Patient interfaces, systems and methods

Abstract

The present invention is directed to a patient interface, system and / or method for providing a dedicated or unique inspiratory line or conduit for providing inspiratory gas to a patient and a dedicated or unique expiratory line or conduit for providing expiratory gas to a downstream device, wherein the inspiratory line or conduit is sealingly engageable with a first nostril of a user and the expiratory line or conduit is sealingly engageable with a second nostril of the user.

Description

[0001] This application is a divisional application of the invention patent with application date of August 31, 2017, application number 201780067487.7 (PCT international application number PCT / IB2017 / 055229), and invention name “PATIENT INTERFACE, SYSTEM AND METHOD”. Technical Field

[0002] The present invention relates to a patient interface, system and method, and more particularly, but not exclusively, to a patient interface, system and method operable to provide gas therapy to a user or as part of a medical breathing circuit or system. Background Art

[0003] Patient interfaces are used in medical breathing circuits to provide a specific or range of gas therapies to a user (eg, a patient receiving gas therapy).

[0004] A patient interface capable of providing dedicated gas therapy or provided as part of a breathing circuit may provide users of the interface or circuit as well as medical professionals with alternative options for delivering desired gas therapy.

[0005] Where reference is made in this specification to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the features of the invention. Unless expressly stated otherwise, reference to such external documents should not be construed as an admission that these documents or these sources of information are prior art or form part of the common general knowledge in the art in any jurisdiction. Summary of the invention

[0006] It is therefore an object of the present invention to provide a patient interface and / or patient interface as part of a medical breathing circuit which will go at least some way towards addressing the aforementioned problems or will at least provide the public with a useful choice.

[0007] In a first aspect, the present disclosure relates to a patient interface comprising:

[0008] a first nasal interface connection component configured to be in fluid communication with a first nostril of a user, and an associated first conduit configured for independent and / or dedicated fluid connection with the first nasal interface connection component;

[0009] a second nasal interface connection component configured to be in fluid communication with a second nostril of the user, and an associated second conduit configured for independent and / or dedicated fluid connection with the second nasal interface connection component;

[0010] One of the following:

[0011] the first nasal interface connecting component to the associated first conduit, or

[0012] The second nasal interface connection component is connected to the associated second conduit

[0013] a single inspiratory line or conduit configured to deliver a source of gas to one of the user's nostrils, and

[0014] The other of the first nasal interface connection component and the associated first conduit or the second nasal interface connection component and the associated second conduit can be configured as a sole exhalation line or conduit that receives gas from the other or second nostril of the user's nostrils.

[0015] The first nasal interface component can be configured to connect to or be partially inserted into a first nostril interface of a user.

[0016] The second nasal interface component can be configured to connect to or be partially inserted into a second nostril interface of the user.

[0017] One or both of the first nasal interface component and / or the second nasal interface component may be configured for a non-sealing interface connection with a user's nostrils.

[0018] Alternatively, the first nasal interface component can be configured for sealing or non-sealing interfacing or engagement with a user's nostrils.

[0019] Alternatively, the second nasal interface component can be configured to interface or engage with the user's nostrils in a sealing or non-sealing manner.

[0020] Alternatively, one of the first nasal interface component and / or the second nasal interface component may be configured to connect or engage with the user's nostrils for sealing or non-sealing interface, and the other of the first nasal interface component and / or the second nasal interface component may be configured to connect or engage with the user's nostrils for sealing or non-sealing interface, and one or both of the first nasal interface component and / or the second nasal interface component may have different nostril sealing capabilities or non-sealing capabilities or have the same nostril sealing capabilities or non-sealing capabilities.

[0021] The first nasal interface component can be configured to interface with or be partially inserted into a first nostril of a user, and the second nasal interface component can be configured to interface with or be partially inserted into a second nostril of a user.

[0022] The first nasal interface component can be configured to substantially sealingly engage or interface with a first nostril of a user.

[0023] The second nasal interface component can be configured to substantially sealingly engage or interface with a second nostril of the user.

[0024] The first nasal interface component can be configured to substantially sealingly engage or interface with a first nostril of a user, and the second nasal interface component can be configured to substantially sealingly engage or interface with a second nostril of a user.

[0025] The first nasal interface component and the second nasal interface component can each include a sealing member for substantially sealing with the user's nostrils. Optionally, the sealing member can take the form of a nasal pillow associated with one or each of the nasal interface components.

[0026] The first nasal interface component and the second nasal interface component can each include a seal.

[0027] Each of the first nasal interface component and the second nasal interface component can be shaped or formed to substantially provide a seal with the user's nostrils.

[0028] The first nasal interface component and the second nasal interface component can be nasal prongs, or can be nasal interface components that include sealing members such as nasal pillows.

[0029] The patient interface may include a divider between the first nasal interface connection component and the second nasal interface connection component.

[0030] The separator may provide a fluid disconnect (which may be mechanical) between the fluid flow path of the first nasal interface connection component and the fluid flow path of the second nasal interface component.

[0031] The divider may provide an adjustable or controllable mechanical fluid connection and / or disconnection between the fluid flow path of the first nasal interface connection component and the fluid flow path of the second nasal interface connection component.

[0032] The divider may comprise a valve. The valve may be a gate valve or a butterfly valve, or an optionally collapsible section of a tube.

[0033] The divider may provide for adjustment of biased flow of a gas source to the first nasal interface component and / or the second nasal interface component.

[0034] A diverter valve may connect a gas source fluid to one of: the first conduit and the first nasal interface component, or the second conduit and the second nasal interface component to provide the inspiratory line or conduit.

[0035] The diverter valve can fluidly connect gas received from one of the first or second nasal interface components via the associated first or second conduit to provide an exhalation line or conduit.

[0036] The associated conduits for the inspiratory line or conduit may be connected to a source of air or another gas, and the associated conduits for the expiratory line or conduit may be connected to a downstream component or device.

[0037] The diverter valve can be operable to divert the gas source to one of the first conduit and the first nasal interface component or the second conduit and the second nasal interface component.

[0038] The diverter valve can be operable to divert gas received from the user via one of the first nasal interface component and the first conduit or the second nasal interface component and the second conduit.

[0039] Alternatively, a diverter valve can be provided for selectively directing a gas source to one of the first conduit and the first nasal interface component or the second conduit and the second nasal interface component to operate as an inspiratory line or conduit, and selectively allowing the other of the first conduit and the first nasal interface component or the second conduit and the second nasal interface component to operate as an expiratory line or conduit.

[0040] The diverter valve can be used to selectively determine:

[0041] the first conduit or the second conduit serving as the inhalation line or conduit for delivering a gas source to the first nasal interface component or the second nasal interface component, and

[0042] The first conduit or the second conduit serves as the exhalation line or conduit for subsequently receiving gas from the first nasal interface component or the second nasal interface component.

[0043] The diverter valve may be operable to allow the source of gas to be delivered alternately to one of the user's first nostril or the user's second nostril.

[0044] The diverter valve may be operable to allow the gas source to be delivered in a manner synchronized with the user's nasal cycle (such as the user's natural alternation of increasing or decreasing obstruction between each of the user's nostrils).

[0045] The diverter valve may fluidly connect the expiratory line or conduit to a downstream device, such as a CPAP bubbler or other device that creates a back pressure of gas in the expiratory line or conduit, or to a return port of a gas source.

[0046] A detector of the pressure or flow of gas in the expiratory line or tube may be used as an indicator of a leak or loss of gas therapy being provided to the user.

[0047] A pressure or flow sensor may be placed in the expiratory line or catheter.

[0048] A signal responsive to pressure or gas flow in the expiratory line or conduit may be generated by the pressure or flow sensor.

[0049] The signal may indicate a leak or loss of gas therapy being provided to the user.

[0050] One or both of the first and second conduits may be non-self-supporting or may collapse in the absence of a minimum gas pressure within the conduit or when the gas pressure within the conduit falls below a predetermined threshold, such as a conduit of an expiratory line or catheter.

[0051] The conduit in fluid communication with the expiratory line or conduit, or the first conduit or the second conduit when provided as or part of an expiratory line or conduit, may include an indicator. The indicator may be capable of changing color to provide a visual indicator of one or more of the following properties or qualities of the expiratory gas: carbon dioxide, temperature, humidity, pressure.

[0052] An inflatable bladder or diaphragm (bladder) may be fluidly coupled to an exhalation line or catheter, with relative inflation of the bladder or diaphragm providing an indicator or indication that gas therapy is being provided to the user.

[0053] A pressure sensor, such as a pressure gauge, may be coupled to the exhalation line or conduit to provide a signal or indicator of the pressure provided to the user or the user's airway, or the pressure of gas in the exhalation line or conduit.

[0054] The indicator may be a visual indicator of the pressure in the expiratory line or catheter.

[0055] The signal generates one or more of: a visual output, an audible output, an alarm when the sensed pressure is above or below a threshold pressure value.

[0056] A first sensor comprising a pressure sensor may be associated with an inspiratory line or tube and a second sensor comprising a pressure sensor associated with an expiratory line or tube.

[0057] The pressure difference between the gas in the inspiratory line or tube and the gas in the expiratory line or tube, or a measurement of the average pressure over the user's nostrils may be determined / measured.

[0058] A single pressure sensor is provided for sampling the pressure in either the inspiratory line or expiratory line or duct or bias flow substantially at the bridge portion of the interface, the sampled pressure providing an approximation of the patient's airway pressure.

[0059] The patient interface may include a retention system for retaining the interface on the face of a user.

[0060] The retention system may be an associated two-piece releasable connection arrangement so that the interface may be positioned on the user's face and removed and repositioned as desired.

[0061] The first part of the two-part releasable connection arrangement may be a skin patch positioned on the user's face and the second part of the two-part releasable connection arrangement is an interface patch positioned on the user-facing side of the patient interface.

[0062] The interface patch can be connected to or attached to the user-facing side of the interface, the user-facing side of the interface patch including one part of a two-part releasable connection arrangement, which is releasably connected to or attachable to the interface-facing side of the skin patch, the interface-facing side of the skin patch including the other of the two-part releasable connection arrangement and capable of receiving the user-facing side of the interface patch.

[0063] A two-part releasable connection system provides the attachment mechanism.

[0064] The attachment mechanism may be configured to secure the user interface and / or the user interface tube to the patient.

[0065] The attachment mechanism can support the nasal cannula on the face of a patient or user and / or can be adapted or modified to support a patient interface or a portion associated with a patient interface (such as an adapter that can be used in combination with a patient interface), such as by including an extension that can be attached to a patch.

[0066] The attachment mechanism can provide for more rapid and / or improved or simplified ease of mounting the user interface to an operating position on a user. This benefit can also facilitate improved or simplified ease of application of an alternative user interface or removal of the user interface from a user as the user cycles between different therapies such as gas and / or medication therapy, e.g., CPAP, high flow, or medication / aerosolized surfactant delivery applications.

[0067] In various embodiments provided by a two-part releasable connection system or attachment mechanism, such a system or mechanism can provide for quick positioning of the interface to a user, and can provide for secure positioning of the interface.

[0068] A two-part releasable connection system or attachment mechanism may provide a first level of securement of the user interface to the user.

[0069] In the event that the user requires additional or increased security positioning or securing of the user interface, a secondary interface securement may be used.

[0070] Optionally, this additional level can include the application of an on patch. Optionally, this on patch can be an adhesive patch and can be mounted on top of a user interface and / or a tube or conduit or line associated with a patient or user interface and can be adhered to a portion of the skin patch.

[0071] The two-part releasable connection system or attachment mechanism may comprise a two-part releasable attachment or connection arrangement.

[0072] The releasable connection arrangement operates between a pair of patches which are respectively affixed to a patient or user and a user interface.

[0073] The first patch is a skin patch that is adhered or otherwise attached to the patient's skin.

[0074] The skin patch includes a user side facing the user's skin and an interface side facing the user interface.

[0075] The user side of the skin patch may be attached to the user's skin by a dermatologically sensitive adhesive (eg, a hydrocolloid).

[0076] The user interface side of the skin patch may be provided with the first part of a two-part releasable attachment or connection system.

[0077] The second patch may be a user interface patch.

[0078] The user interface patch may include a patient or user side and an interface or user interface side.

[0079] When the attachment mechanism or two-part releasable connection system is engaged, the patient side or user side of the user interface patch may be positioned adjacent the skin patch.

[0080] The or a complementary second part of the two-part releasable attachment or connection system may be affixed to the patient side or user side of the user interface patch so that the corresponding parts of the two-part releasable attachment or connection system are engageable when the patches are put together.

[0081] The interface side or user side of the user interface patch may be affixed to a user interface.

[0082] The user interface patch may be integral with the user interface or suitably adhered to the user interface.

[0083] A portion or corner of the user interface patch may include an area that is not attached to the skin patch. Optionally, such an area (or tab) may be grasped by a user or caregiver to remove or detach the interface from the skin patch.

[0084] The two-part releasable attachment or connection arrangement or system may include one or more of the following: a hook and loop material (such as Velcro TM ), a magnet or an array of magnets arranged on respective patches with the poles suitably arranged, an adhesive arrangement activated when the patches are pushed together, or another suitable releasable suitable connection.

[0085] The interface side of the skin patch may include one of the hook or loop materials, and the patient side or user side of the user interface patch may include the other of the hook or loop materials, so that the skin patch and the user interface patch are releasably attached or connected to each other.

[0086] When referring to hook and loop materials, the hook and loop materials may refer to any of a variety of zone-type mechanical fasteners. For example, Velcro TM The product range may include hook and loop products where the hook component comprises upstanding nylon hooks (formed as cut loops through a woven backing web) that engage with any complementary loop fleece material. TM The range may also include extruded hook products that are typically smaller in size and are mated to a "fluffy" non-woven fiber backing material. These hook materials are designed to work with a range of loop substrates and in some cases, also function as the loop substrate. Other similar systems include the Dual-Lock from 3M Company, St. Paul, Minnesota, USA TM Reclosable fastener system. The common feature of these releasable fastening systems is that they engage at any contact portion between the two parts of the system. No precise alignment of individual connectors is required, because there are many connectors distributed over the entire area of ​​the product. Various releasable fastener systems in the field can be used in releasable attachment mechanisms to provide releasable attachment between the skin patch and the user interface.

[0087] The first part of the two-part releasable attachment or connection system can be adhered to the user interface side of the skin patch using a suitable adhesive and can occupy up to 100% or less than about 90%, or about 85%, or about 75%, or about 60%, or about 50%, or about 40%, or about 30%, or about 20%, or about 10% of the surface area of ​​the interface side of the skin patch.

[0088] In some embodiments, the dermal patch may be a generally planar pad that is less thick than it is wide and long.

[0089] In some embodiments, the pad has a generally oval shape, but may take other shapes.

[0090] The pad may include a first part of a two-part releasable attachment mechanism or connection system.

[0091] In some embodiments, the structure of the skin patch can be such that a first portion of a releasable attachment mechanism or connection system can include a substrate and a plurality of fastener elements (e.g., having active hooks, active loops, or other elements) provided substantially across an area of ​​the substrate.

[0092] The substrate may be secured to the body of the skin patch.

[0093] In some embodiments, the substrate may be secured by an adhesive or by direct bonding during formation of the skin patch.

[0094] In some embodiments, the substrate can be smaller than the skin patch in area and can be positioned on the skin patch so that it does not reach any edge of the skin patch. In this way, for example, the edge of the substrate extends from the edge of the skin patch that completely surrounds the perimeter of the substrate.

[0095] In some embodiments, a substrate for the first part of a two-part releasable attachment mechanism or connection system may be flexible such that a flat surface of the substrate may be bent to follow a surface that curves in one direction.

[0096] The pad of the dermal patch may be stretchable and conformable to a surface that curves in more than one direction as may be required to conform to the contours of the placement location on the patient or, for example, on the user's face.

[0097] According to various embodiments described herein, the first portion of a two-part releasable mechanism or connection system may take on or have a form in which a portion of a substrate may be divided into a plurality of regions by at least one seam or at least one groove, such that different portions of the substrate portion may be bent substantially independently and thereby the overall form of the substrate portion may be deformed to substantially match a surface that bends in two directions.

[0098] In another embodiment, the attachment mechanism or two-part releasable connection system may include a skin patch and a fixation patch.

[0099] The fixation patch may extend substantially over the user interface and / or tube or catheter or line and may be adhered to the skin patch to substantially secure the interface and / or tube or catheter or line to the patient or user.

[0100] The skin patch may define a fixed footprint that is attached to the patient or user.

[0101] The user side of the dermal patch may be configured to attach or adhere to the skin of a patient or user.

[0102] The securement patch may extend over the user interface and / or associated user interface tube or conduit or tubing and adhere to the skin patch to secure the user interface to the patient or user.

[0103] The fixation patch and the skin patch may be configured such that when the fixation system is applied to a patient or user in conjunction with a suitable or compatible user interface, the fixation patch may be contained within or substantially bounded by the fixation footprint of the skin patch.

[0104] The skin patch may comprise the same or greater surface area than the fixed patch.

[0105] The skin patch may comprise one part of a two-part mechanical fastener system across its surface or portions of its surface, wherein the securing patch comprises the other part of the fastener system.

[0106] The skin patch may be sized to reduce the likelihood that the tape or any additional tape will extend onto the user's skin.

[0107] It should be understood that there are many disadvantages and problems associated with the repositioning of interfaces, particularly infant interfaces. These include "snub noses", epidermal abrasions, or skin irritation from conventional tape-applying techniques used to apply user interfaces (e.g., nasal cannulas) to users. Such problems can also arise in the following process: the user cycles between different treatment options and conventionally subsequently removes the headband or tape or user interface and then installs a new device and user interface or interface positioning headband or other tool. Therefore, providing a fixing system that is in a ready-to-receive mode for receiving a user interface when applied to the user is a useful step in the progress toward reducing the problems that users have previously faced. Further, improving the ease of installation has further benefits in terms of complexity and the time and work of the caregiver (e.g., nurse).

[0108] The shape of the fixation patch may be shaped or otherwise configured to accommodate geometric or other features of a patient or user interface and / or associated user interface tube or conduit or tubing.

[0109] The fixation patch may include a plurality of wings that accommodate a user interface tube or catheter or line and may increase the contact surface of the fixation patch that is exposed to the skin patch.

[0110] The fixation patch may comprise a pair of wings arranged at one end of the patch.

[0111] The wings can be configured to be fixed to the skin patch on either side of the patient or user interface and / or associated user interface tube or conduit or pipeline. Optionally, this can help reduce the possibility of the fixed patch folding around the interface and / or tube or conduit or pipeline.

[0112] The fixation patch may include tube end wings. Optionally, the tube end wings may be configured to extend under the patient or user interface tube or catheter or line and adhere substantially to the skin patch, thereby connecting the ends of the fixation patch.

[0113] The above-described attachment mechanisms may be used to secure a tube or catheter or line to any part of a patient's body, including but not limited to the patient's face, particularly adjacent the user's upper lip and / or cheek. Infant applications may be particularly relevant.

[0114] The user side of the skin patch may include a dermatologically sensitive adhesive (such as a hydrocolloid) that adheres the patch to the user's skin.

[0115] The skin patch can have sufficient surface area to distribute adhesive forces and interface retention forces over appropriate areas of a user's skin (such as the user's face) to reduce localized pressure buildup.

[0116] In some embodiments, a securing system is provided for maintaining, holding, or securing a pressure and / or drug lumen (such as a surfactant lumen or a nasogastric lumen) in place on a patient's face or body.

[0117] In some embodiments, the pressure lumen can be configured to be fluidly connected to a pressure tube or pressure port of a patient interface, and a drug delivery port (such as a surfactant delivery port) can be configured to be fluidly connected to a drug delivery tube, such as a surfactant delivery tube or a nasogastric tube.

[0118] In some embodiments, the securement system comprises a two-part releasable attachment or connection arrangement.

[0119] A releasable connection arrangement may be effected between a pair of components respectively affixed to a user or patient and a pressure and / or drug tube.

[0120] The two-part releasable attachment mechanism may optionally further include structures for holding pressure and / or drug tubes. In some embodiments, these structures may be retainers, clips, flaps, etc.

[0121] The two-part releasable attachment mechanism may include a panel configured to fold over the skin patch to retain the tube.

[0122] The skin patch and the panel may be joined together at the edge regions.

[0123] In order to connect the first and second parts of the two-part releasable attachment system together, the panel can be folded over the skin patch so that the patient side or user side of the panel is adjacent to the user side or patient interface side of the skin patch to connect the first and second parts of the two-part connection system together, optionally capturing or clamping a tube or catheter or line therebetween.

[0124] The two-part releasable attachment mechanism may further include a clip for securing a pressure and / or drug delivery tube, such as a surfactant tube.

[0125] A dermal patch for adhering to the skin of a user or patient may include a securing clip attached to or formed integrally with the dermal patch.

[0126] The fixing clip may comprise a recess or cavity or channel for receiving the tube. Optionally, the recess may be open so that a section of the tube or conduit or line may be pushed into the clip in a lateral direction relative to the longitudinal axis of the tube.

[0127] The recess may comprise a lateral dimension similar to or smaller than the diameter of a tube or conduit or line, such that the tube or conduit or line may be securely clamped by the clamp.

[0128] In one embodiment, the clip may be releasable from the skin patch. For example, the aforementioned two-part connection system or attachment mechanism may be applied between the clip and the skin patch. Alternatively, the clip may be releasably attached to a patient or user interface.

[0129] In various embodiments, a two-part releasable attachment mechanism or connection system may include a wing portion configured to wrap around and secure a pressure and / or drug delivery tube or catheter or line, such as a surfactant delivery tube.

[0130] Such a fixing system may comprise a skin patch for attachment to the patient's or user's face. Optionally, the skin patch may comprise a wing portion for wrapping around a tube or catheter or line once the tube or catheter or line has been correctly positioned in the user's or patient's nostril.

[0131] The holding system may be a headband. The size of the headband may be adjusted to the user's head.

[0132] One or more drugs may be delivered to the inspiratory line or catheter or to the nasal interface connection component (when provided as part of the inspiratory line or catheter). One or more drugs may be atomized or nebulized or aerosolized for delivery into the gas flow in the inspiratory line or catheter or into the gas flow path of the nasal interface connection component (when operable as part of the inspiratory line or catheter).

[0133] One or more drugs may be provided in the flow of gas supplied to the user or patient as an inspiratory flow.

[0134] The drug delivery port may be placed in fluid connection or communication with one or both of the nasal interface connection elements.

[0135] The drug delivery port can be configured to be in fluid connection or communication with a single one or one of the nasal interface connection elements, and the diverter valve is operated or properly matched to provide the gas source or gas supply to the nasal interface connection element associated with the drug delivery port, thereby ensuring that one or more drugs are delivered or administered into the gas flow being delivered as an inspiratory flow to the user or patient.

[0136] Alternatively, the drug delivery port can be configured to be in fluid connection or communication with two (or both) nasal interface connection elements, and the drug diverting valve is operated or properly matched to divert one or more drugs to be delivered or administered to the user or patient to the nasal interface connection element or to a line or conduit associated with the nasal interface connection element being supplied by a gas supply source, thereby ensuring that the drug is delivered to the gas flow being delivered to the user or patient as an inspiratory flow.

[0137] One or more drugs may be provided to the gas flow being supplied to the nasal interface connection element selected as the inspiratory nasal interface connection element. Optionally, nasal interface connection element selection may be achieved by using a diverter valve upstream of the nasal interface connection element.

[0138] One or more drugs may be provided to the gas flow being supplied to the nasal interface connection element selected as the inspiratory nasal interface connection element. Optionally, nasal interface connection element selection may be achieved by using a drug diverting valve to selectively divert the delivery or administration of one or more drugs via the port to the selected inspiratory nasal interface connection element.

[0139] A specific one of a pair of nasal interface connection elements of a patient interface can be selected as an inhalation nasal interface connection element by a diverter valve, and the diverter valve can be appropriately associated with or connected to a mechanism associated with a drug port (such as a drug diverter valve) to selectively divert or direct the drug administered via the port to the selected inhalation nasal interface connection element.

[0140] Alternatively, a valve or diverter valve or selector may be operably adjustable at the port or elsewhere on the patient interface for selecting one of the nasal interface connection elements, or one of the associated conduit and nasal interface connection elements to fluidly connect with the port to receive medication administered via the port. Optionally, the valve or diverter valve or selector allows a line or conduit connected to the port to mate or fluidly couple with the nasal interface connection element selected as the inspiratory line or conduit for delivering medication to the user or patient via the port.

[0141] A patient interface may be provided as part of a closed breathing circuit.

[0142] The patient interface may be configured to provide continuous positive airway pressure (CPAP) gas therapy to the user. Optionally, the gas therapy for the user may include but is not limited to the following: non-invasive positive pressure ventilation (NIPPV), bi-level positive airway pressure (BiPAP) or other ventilation strategies may be used.

[0143] It should be appreciated that the following additional types of gas therapy may be used or combined to provide therapy to the user, including but not limited to:

[0144] • A pressure controlled ventilator, such as that manufactured by Drager / Maquet / Hamilton.

[0145] • Flow-actuated (SiPAP) ventilators with pressure feedback, such as using a flow actuator.

[0146] Various (humidified) gas sources with appropriate pressure controls (e.g., bubbles, PEEP valves) on the expiratory line or conduit of the medical breathing circuit or system or on the associated conduits or branches of this part, including gas blenders, oxygen / medical gas bottles, high flow devices (including, for example, the Airvo TM systems, or CPAP blowers (including, for example, those manufactured by Fisher & Paykel Healthcare Ltd. called Icon TM system).

[0147] • A humidifier or other suitable gas conditioning may be provided for the gas being delivered to the user.

[0148] The patient interface and the system to which the interface may be associated or arranged to be in fluid connection may be supplied or arranged with a humidification source for the gases delivered to the user. Advantageously, supplying or providing a humidification source is important to help reduce dryness or dehydration of the airways, for example in the case of constant unidirectional flow across the nasal mucosa.

[0149] A unique expiratory line or conduit may be fluidly coupled to a downstream device configured to provide a predetermined or adjustable back pressure or PEEP substantially at the opening of the nasal interface connection component provided as an expiratory line or conduit for the user.

[0150] Each nasal interface connection component may include a fluid pathway connected at one end by the conduit providing an independent / dedicated fluid connection and connected at the other end by an opening for fluid connection with a user's nostril with which the nasal interface connection component sealingly interfaces.

[0151] The gas source may be a pressurized source, or the source may be pressurized by an upstream device configured to provide an adjustable or controllable gas pressure to the opening of the nasal interface connection component configured as a sole inspiratory line or conduit.

[0152] In a second aspect, the present disclosure relates to a patient interface comprising:

[0153] a pair of nasal interface connection components, one of the pair being configured to deliver inspiratory gas to only one of the user's nostrils and the other of the pair being configured to receive expiratory gas from only the other of the user's nostrils;

[0154] A valve is operable to selectively control which of the nasal interface connection components provides the inspiratory gas to the user and which of the nasal interface connection components receives the expiratory gas from the user.

[0155] In a first mode, the valve may be operable to allow inspiratory gas to be delivered to a first nasal interface connection component of a pair of nasal interface connection components and to allow a second nasal interface connection component of the pair of nasal interface connection components to receive exhaled gas from a user;

[0156] And in the second mode, the valve can be operated to allow inspiratory gas to be delivered to the second nasal interface connection part of the pair of nasal interface connection parts and allow the first nasal interface connection part of the pair of nasal interface connection parts to receive exhaled gas from the user.

[0157] In a third aspect, the present disclosure relates to a patient interface comprising:

[0158] a pair of nasal interface connection components, one of the pair being configured to deliver inspiratory gas to only one of the user's nostrils and the other of the pair being configured to receive expiratory gas from only the other of the user's nostrils;

[0159] a valve, such as the diverter valve described above, operable to selectively control which of the nasal interface connection components provides the inspiratory gas to the user and which of the nasal interface connection components receives the expiratory gas from the user;

[0160] wherein in the first mode, the valve allows inspiratory gas to be delivered to a first nasal interface connection component of a pair of nasal interface connection components and allows a second nasal interface connection component of the pair of nasal interface connection components to receive exhaled gas from the user;

[0161] And in the second mode, the valve allows inspiratory gas to be delivered to the second nasal interface connection part of the pair of nasal interface connection parts and allows the first nasal interface connection part of the pair of nasal interface connection parts to receive exhaled gas from the user.

[0162] In a fourth aspect, the present disclosure relates to a patient interface, comprising:

[0163] a pair of nasal interface connection components arranged to be in fluid communication with the nostrils of a user;

[0164] a bridge portion mechanically connected to the nasal interface connection component;

[0165] Wherein, the bridge portion includes a bridge valve configured to fluidly connect each of the nasal interface connection components, such as the valves described above with respect to allowing bias flow.

[0166] Each nasal interface connection component may include a gas passageway having an opening at one end for fluidly communicating with a user's nostril and an associated conduit at the other end of the gas passageway for extending the gas passageway.

[0167] The bridge valve may be operable to adjust or control the bias flow of gas being delivered to the user.

[0168] The valve is operable to selectively control which of the nasal interface connection components provides inspiratory gas to the user and which of the nasal interface connection components receives expiratory gas from the user;

[0169] wherein in the first mode, the valve allows inspiratory gas to be delivered to a first nasal interface connection component of a pair of nasal interface connection components and allows a second nasal interface connection component of the pair of nasal interface connection components to receive exhaled gas from the user;

[0170] And in the second mode, the valve allows inspiratory gas to be delivered to the second nasal interface connection part of the pair of nasal interface connection parts and allows the first nasal interface connection part of the pair of nasal interface connection parts to receive exhaled gas from the user.

[0171] One of the pair of nasal interface connection components may be configured to deliver inspiratory gas only to one nostril of the user, and the other nasal interface connection component of the pair may be configured to receive expiratory gas only from the other nostril of the user.

[0172] In a fifth aspect, the present disclosure relates to a patient interface, comprising:

[0173] a first nasal interface component for providing a fluid connection with a first nostril of a user,

[0174] an inspiratory gas pathway in fluid communication between the first nasal interface component and a gas source to provide inspiratory gas to the first nostril of the user,

[0175] a second nasal interface component for providing a fluid connection with a second nostril of the user, and

[0176] an exhalation gas passage for receiving exhalation gas from a second nostril of a user,

[0177] Therein, the fluid connection between the inhalation gas passage and the second nose piece is mechanically disconnected.

[0178] In a sixth aspect, the present disclosure relates to a patient interface, comprising:

[0179] a first nasal interface component for providing a substantially sealed fluid connection with a first nostril of a user,

[0180] an inspiratory gas pathway in fluid communication between the first nasal interface component and a gas source to provide inspiratory gas to the first nostril of the user,

[0181] a second nasal interface component for providing a substantially sealed fluid connection with a second nostril of the user, and

[0182] an exhalation gas passage for receiving exhalation gas from a second nostril of a user,

[0183] Therein, the inhalation gas passage is not in fluid communication with the second nose piece.

[0184] In a seventh aspect, the present disclosure is directed to a method of delivering a unidirectional gas flow through a dedicated inlet nasal interface connection component and conveying an exhaled gas flow through a dedicated outlet nasal interface connection structure so that the gas flow is turned or redirected within the nasal passages of a user.

[0185] Both nasal interface connection components may be configured to seal with the user's nostrils.

[0186] The unidirectional gas flow can be selectively directed to the first nasal interface connection component or the second interface connection component, the selected nasal interface connection component becomes the dedicated inlet nasal interface component, and the other nasal interface connection component becomes the dedicated outlet nasal interface connection component.

[0187] The flow redirector may be operable to selectively redirect the flow of gas to either the first nasal interface connection component or the second interface connection component.

[0188] The divider or fluid path controller may be operable to facilitate fluid connection between each of the first nasal interface connection component and the second interface connection component.

[0189] A divider or fluid path controller may be operable to control or adjust the bias flow of gas flow delivered to the nasal interface connection component.

[0190] In an eighth aspect, the present disclosure is directed to a method of administering gas therapy to a user, the method comprising:

[0191] Delivering a first gas flow to a first nasal interface connection component as an inspiratory flow, wherein the first nasal interface connection component is configured to be in fluid communication with a first nostril of a user;

[0192] receiving a second gas flow as an exhalation flow from a second nasal interface connection component, the second nasal interface connection component being configured to be in fluid communication with a second nostril of the user;

[0193] The expiratory flow is controlled.

[0194] The exhaled flow may be controlled according to any one or more of the following gas parameters: pressure, flow rate.

[0195] The exhaled flow may be controlled to provide an upstream parameter according to any one or more of the following: pressure, flow rate.

[0196] The parameter to be controlled may be a parameter used to influence the pressure of gas provided to or experienced by the airway of a user.

[0197] The gas therapy delivered to the user may be CPAP gas therapy.

[0198] Expiratory flow (or optionally inspiratory flow) may be controlled by or directed to one or more of the following:

[0199] a bubbler or bubble CPAP device or another pressure regulator (such as a positive end-expiratory pressure ("PEEP") valve) for regulating the pressure provided to or experienced by the user's airway;

[0200] A ventilation or resuscitation device, such as for providing any one or more of the following gas therapy to the user, including but not limited to continuous positive airway pressure (CPAP), BiPAP, NiPPV;

[0201] A flow generating device or flow driver, such as for providing desired gas therapy to the user, including but not limited to SiPAP.

[0202] In a further aspect, a patient interface, system and / or method is disclosed for providing a dedicated or unique inspiratory line or conduit for providing inspiratory gas to a patient and a dedicated or unique expiratory line or conduit for providing expiratory gas to a downstream device, wherein the inspiratory line or conduit is sealingly engageable with a first nostril of a user and the expiratory line or conduit is sealingly engageable with a second nostril of the user.

[0203] In various embodiments, the patient or user interface may be modified or configured to receive and / or secure the adapter and any necessary tubes, such as a drug delivery tube or a nasogastric tube.

[0204] The tube may extend from one or both sides of the user's face.

[0205] In some embodiments, the user or patient interface and fixation system described above may include a dynamic interface for accommodating facial movements of the patient.

[0206] This dynamic interface can suppress the effects of facial movement on the positioning of the patient interface around the patient's nose.

[0207] In some embodiments, a dynamic interface may include or incorporate one or more hinges along the interface (or device) that responds to natural and forced facial movements as well as external forces applied to the interface.

[0208] As used herein, the term "hinge" generally refers to a portion of an interface that is configured to bend in one or more directions. A hinge can be configured to bend in one or more predetermined directions, and in some embodiments, a hinge can be constrained from bending in certain directions.

[0209] In another aspect, a user or patient interface suitable for use in the above aspects may broadly include a patient interface, such as a nasal cannula, comprising:

[0210] a body to be positioned on a user (preferably, such as on the user's face),

[0211] the body comprising at least one (and preferably a pair) nasal prong, the or each nasal prong comprising an internal cavity fluidly connectable thereto for fluid communication with a supply of breathable gas, the or each nasal prong being configured to be inserted into or direct a flow of gas towards one or more nostrils of a user's nose,

[0212] wherein the body comprises at least one element that is (optionally mechanically) responsive to force or motion or both experienced by at least a first area of ​​the patient interface; optionally or alternatively, wherein the body comprises at least one element that is (optionally mechanically) capable of responding to force or motion or both experienced by at least a first area of ​​the patient interface so as to prevent them from being transmitted to at least one other area of ​​the patient interface.

[0213] The element may help reduce the transfer of force or motion, or both, applied to at least a first region of the interface from being transferred to at least another region of the interface.

[0214] The element may respond by localizing the force or motion or both experienced by at least the first region.

[0215] The element may respond so as to minimize or prevent the transfer of force or motion or both from at least the first region to at least one other region of the patient interface.

[0216] The element may respond by maintaining at least one (and preferably a pair) of nasal prongs in a configuration for insertion into one or more nostrils of a user's nose, or in a configuration for directing a flow of gas toward one or more nostrils of a user's nose.

[0217] The response may be such that at least one (or preferably, a pair) of nasal prongs are maintained in a stable position within or adjacent to the nostril of the user's nose to which the nasal prongs are directed.

[0218] The response may be such that the interface maintains an operative position on the user.

[0219] The force or motion or both experienced by at least the first region of the interface may be either or both of the following:

[0220] force(s) or motion(s) between the nasal prong(s) and the body of the patient interface, or

[0221] (Multiple) forces or (multiple) movements between the body of the patient interface and (multiple) nasal prongs.

[0222] The element may be deformable or may deform in response to a force or movement, or both, experienced by at least a first region of the interface.

[0223] The element may have a predetermined or preferential deformation pattern in response to an applied force or motion, or both, experienced by at least a first region of the interface.

[0224] The element may be deformable by one or a combination of compression or tension or torsion or bending or other flexure.

[0225] The element may respond to the force or motion, or both, experienced by at least the first region of the interface by one or a combination of: changing shape, changing position, changing configuration, or deforming.

[0226] Elements may include one or any combination of the following:

[0227] hinge, pivot, articulated joint of a body or part associated with a body or part connected in an articulated manner, swivel, ball and socket joint, pin-in-tube joint,

[0228] A material that is relatively less flexible than other parts of the interface; a material that is relatively more flexible than other parts of the interface; a material whose properties change when a force or motion is applied, such as by increasing its resistance to the applied force or motion (or both) or by decreasing its resistance to the applied force or motion (or both); or a material that is elastically deformable in response to an applied force or motion (or both), or a material that is preferentially deformable in specific or predetermined geometries but optionally resists deformation in other specific or predetermined geometries.

[0229] An element can be one or more of the following:

[0230] A pivot (or swivel) or an area capable of pivoting (or rotating), or

[0231] a hinge or an articulated region or a region that is capable of being articulated relative to another part of the interface or another region of the interface, or

[0232] A joint or an articulated joint or an area capable of articulation.

[0233] The element may decouple force or motion (or both) applied to at least a first region of the interface from being transmitted to at least one other region of the interface.

[0234] An element may be provided or operable to or act to prevent or minimise the transfer of force or motion from at least a first region of the interface to at least one other region of the interface.

[0235] An element may be a structure or mechanism of an interface, or may be a region of an interface.

[0236] The element may be deformable about at least one axis or at least one plane.

[0237] The element may be deformable about a preferential first geometric shape.

[0238] The element may be deformable by one or a combination of compression or tension or torsion or bending or other flexure.

[0239] There may be two or more elements positioned around the interface.

[0240] Elements can be connected together in a way that provides a combined response to force or motion (or both).

[0241] Elements can respond to force or motion (or both) in different modes, providing a combined response.

[0242] The elements may be operably coupled to each other, or to other parts of the interface, to provide or provide a combined response.

[0243] At least one of the elements or each such element may be provided as one or more of the following:

[0244] Isolators or isolated areas,

[0245] absorber or absorbing area,

[0246] Suppressor or suppression area,

[0247] Or any other structure or mechanism that provides a reactive response to force or motion applied to at least a first area of ​​the patient interface so as not to be transmitted to at least a second area or another area of ​​the patient interface.

[0248] The response of one or each element may be to at least one of isolate or absorb or suppress or reduce (or a combination thereof) force or movement applied to at least the first area so as to prevent it from being transmitted to at least one other area of ​​the patient interface during use by the user.

[0249] Such force or motion may be caused by a user of the interface changing the geometry of the user's face in which the interface is held, located or positioned, or by the user pulling on or applying force or motion to or to the interface or a headband associated with the interface, or by a breathing circuit or other component of the interface applying force or motion, such as by applying downward pressure on a portion of the interface or a headband associated with the interface.

[0250] Forces or motions between the nasal prongs and the body of the patient interface or between the body of the patient interface and the nasal prongs may be caused by changes in the user's facial geometry, such as during speaking, eating, sleeping, or other facial distortions between relaxed and exaggerated states.

[0251] At least one element or at least one of the elements may be positioned in a bridge region of the nasal cannula patient interface to facilitate movement of the bridge region in response to force or displacement or both (and additionally, may be such as substantially adjacent to a diaphragm region of a user).

[0252] An interface may include multiple elements that are used alone or in combination with other elements to provide a response.

[0253] At least one element may be an articulated portion located or positioned as a bridge between a left body portion and a right body portion, each of which together form a body of an interface to be positioned on the face of a user, such articulated portion providing a preferential deformation area in response to at least a first area of ​​the body or a portion of the body to withstand forces or movements (or both) originating from changes in the facial geometry of the user.

[0254] The patient interface may be substantially conformable or conformable to the facial geometry of the user such that the elements respond to force or movement (or both) to substantially maintain the interface in a preferred therapy delivery configuration for the user.

[0255] In a further aspect, a patient interface that can be used for the above-mentioned aspects can broadly include a patient interface, such as a nasal cannula, comprising: a pair of corresponding left and right body portions, which will be positioned on the face of the user during use; and a bridging portion extending between each of the left and right body portions; a nasal prong extending from one or each of the more internal ends of the corresponding left and / or right body portions, or from an area substantially adjacent to the more internal ends of one or both of the corresponding body portions, the nasal prong being to be inserted into one or more nostrils of the user's nose or directing the flow of gas into one or more nostrils of the user's nose, the bridging portion allowing the corresponding body portions to move in a manner such that the more internal ends of the body portions move toward each other, but resisting movement of the corresponding body portions in a manner such that the more internal ends of the body portions move away from each other.

[0256] When the patient interface is in place on the user's face, displacements in the position of one or both of the left and / or right body portions can be transmitted to the bridge member in a manner that minimizes movement of one or more nasal prongs relative to the user's nostrils.

[0257] The bridge portion may extend and connect the more interior ends of the respective body portions.

[0258] The bridge portion may be a material that is capable of undergoing compression and resisting or withstanding tension applied thereto in a direction extending between the corresponding more interior ends of the body portion.

[0259] The direction extending between the respective more inner ends of the body portions is a longitudinal direction extending along the respective body portions.

[0260] The bridging portion may comprise a textile material.

[0261] The bridge portion may be axially expandable / stretchable but resilient so as to resist movement of the corresponding body portion in such a way that the more inner ends move away from each other.

[0262] The length of the bridge portion between the connection point on the left body portion and the connection point on the right body portion can be greater than the distance between the nose forks.

[0263] The bridging portion may comprise a flexible polymer material.

[0264] In a further aspect, a patient interface that can be used for the above-mentioned aspects can broadly include a patient interface, such as a nasal cannula, comprising: a pair of corresponding left and right body portions, which will be positioned on the face of a user during use; a bridging portion extending between each of the left and right body portions; and a nasal prong extending from one or each of the more internal ends of the corresponding left and / or right body portions, or from an area substantially adjacent to the more internal ends of one or both of the corresponding body portions, the nasal prong being inserted into one or more nostrils of the user's nose or directing a flow of gas into one or more nostrils of the user's nose, wherein one of the corresponding body portions, and preferably both, includes a user face contact surface oriented relative to the corresponding nasal prong so that when in place, a torsional force applied to the left and / or right body portions substantially holds the nasal prong in the nostrils of the user's nose or in a position for directing a flow of gas into the nostrils of the user's nose.

[0265] Rotation of the body portion or rotation of the two body portions toward the user's face can maximize the contact surface area between the facial contact surface and the user's face and position the nasal prongs into the nostrils of the user's nose or position the nasal prongs in a position for directing the gas flow into the nostrils of the user's nose.

[0266] The bridge section may have a relatively smaller diameter than the left and right body portions.

[0267] Each body portion may include a channel that is fluidly connected at one end to a corresponding nasal prong and is open at an opposite end for fluidly coupling a gas flow path of the breathing circuit.

[0268] At least one or each of the left and right body portions may include an axially twisted face contacting surface movable between a relaxed position and a twisted position in which the surface area for positioning adjacent a user's face is increased.

[0269] The face contacting surface may twist axially along the length of the body portion from an inner end of the body portion to an outer end of the body portion.

[0270] The face contacting surface may extend helically along the length of the body portion.

[0271] In the relaxed position, the face contact surface can be distally away from the extension direction of the nasal prongs, and in the twisted position, can face the extension direction of the nasal prongs and be substantially planar along a substantial length of the body portion.

[0272] One or more nasal prongs may be angled relative to respective left and right body portions so as to exert a torque on the body portions when the nasal prong is inserted into a nostril of a user's nose.

[0273] The face contacting surface of the respective left and / or right body portions may be contoured to engage the cheeks of the user's face.

[0274] In a further aspect, a patient interface that can be used for the above-mentioned aspects can broadly include a patient interface, such as a nasal cannula, comprising: a pair of corresponding left and right body portions, which are to be positioned on the face of a user during use; and a bridging portion extending between each of the left and right body portions; a nasal prong extending from one or each of the more inward ends of the corresponding left and / or right body portions, or from an area substantially adjacent to the more inward ends of one or both of the corresponding body portions, the nasal prong being to be inserted into one or more nostrils of the user's nose or directing a gas flow into one or more nostrils of the user's nose; and a series of discrete and separated facial contact surfaces that are movable relative to each other so as to respond to forces or movements or both experienced by the facial contact surfaces and at least partially reduce the transmission of such forces and / or movements to the nasal prongs.

[0275] In a further aspect, a patient interface that can be used in the above-mentioned aspects can broadly include a patient interface, such as a nasal cannula, comprising: a pair of corresponding left and right body portions, each of which will be positioned on the face of a user during use; and a bridge portion extending between the left and right body portions; and a nasal prong extending from one or each of the more internal ends of the corresponding left and / or right body portions, or from an area substantially adjacent to the more internal ends of one or both of the corresponding body portions, the nasal prong being inserted into one or more nostrils of the user's nose or directing a flow of gas into one or more nostrils of the user's nose, wherein the cannula includes at least one articulation region, at least one articulation region being pivotable relative to another region of the cannula about at least a pair of substantially orthogonal axes, or along a pair of substantially orthogonal planes, or both, so as to respond to forces or movements or both experienced by the other regions and at least partially reduce the transmission of such forces and / or movements to the nasal prong.

[0276] At least one articulation region may be pivotable about three substantially orthogonal axes, or along three substantially orthogonal planes, or both.

[0277] The bridge may include a bridge hinge adjacent to the nasal prongs or located between a pair of nasal prongs.

[0278] The bridging hinges may be pre-arranged to have a large curvature.

[0279] The hinge may be pre-arranged to bend inwardly towards the user and downwardly away from the nostril when in place.

[0280] The bridge may further include a second hinge located on one side of the bridge hinge, or a pair of opposing second hinges located on both sides of the bridge hinge and adjacent to one or more nose forks.

[0281] The second hinge or each hinge of the pair of second hinges may be pre-arranged to have a large curvature.

[0282] The second hinge, or each hinge of a pair of second hinges, may be pre-arranged to bend upwardly towards the user's nostrils and outwardly away from the user when in position.

[0283] The bridge may include a third hinge adjacent to the left body portion or the right body portion, or a pair of third hinges arranged adjacent to the respective left and right body portions.

[0284] The third hinge or each hinge of a pair of third hinges may be pre-arranged to have a large curvature.

[0285] The third hinge, or each of the pair of third hinges, may be pre-arranged to flex downwardly away from the nostril and outwardly away from the user when in place.

[0286] When in place, one end of the bridge portion may extend substantially orthogonally from the third hinge, or either end of the bridge portion may extend substantially orthogonally from either of the pair of third hinges and inwardly towards a cheek of the user's face.

[0287] Each body portion may include a face pad contoured to engage an area of ​​a user's face.

[0288] Either end of the bridge portion may extend along at least a portion of the face pad.

[0289] The bridge portion may be substantially hollow at least at either end of the bridge portion to facilitate the passage of a gas flow therethrough.

[0290] Either end of the bridge portion may be configured to couple to a gas flow path of a breathing circuit.

[0291] The, or each, nose prong may extend from and be fluidly connected to a respective end of the bridging portion.

[0292] The bridge portion may comprise an annular cross-section along at least a substantial portion of the length of the bridge portion.

[0293] The bridge may further include a fourth hinge adjacent to the third hinge, or a pair of fourth hinges adjacent to the pair of respective third hinges.

[0294] The fourth hinge or each hinge of a pair of fourth hinges may be pre-arranged to have a large curvature.

[0295] The fourth hinge, or each hinge of a pair of fourth hinges, may be pre-arranged to bend downwardly away from the user's nostrils and inwardly towards the user's facial cheeks when in place.

[0296] Each body portion may include a face pad contoured to engage an area of ​​a user's face.

[0297] In a further aspect, a patient interface that can be used in the above-mentioned aspects can broadly include a nasal interface constructed to stabilize nasal prongs on the patient's face when force is applied to the interface, the nasal interface comprising: a slender body having an overall curvature substantially corresponding to the patient's facial contour, the body being constructed to be connected to a gas flow source and including at least one inner cavity extending at least partially through the body; a pair of nasal prongs extending from the body and being in fluid communication with the at least one inner cavity; and one or more hinges, at least one hinge being arranged between the pair of nasal prongs, the at least one hinge being pre-arranged to bend in a predetermined direction.

[0298] The patient interface may further include one or more facial pads configured to rest on the patient's face.

[0299] At least one hinge disposed between the pair of nose prongs may have a curvature that is substantially opposite to the overall curvature of the elongated body.

[0300] At least one hinge disposed between the pair of nasal prongs may be configured to bend inwardly toward the patient's face.

[0301] The nasal interface can have a generally gull-wing shape.

[0302] The nasal interface can have a wavy shape.

[0303] The nasal interface can have a curved space frame-like support structure.

[0304] The nasal interface can be curved in more than one dimension.

[0305] The one or more hinges may include one or more of: a notch, a variable cross-sectional area, a variable thickness, two or more materials with different flexibility, an elastic hinge constructed to be pre-stressed prior to application to the patient, a cylinder and pin, and / or a ball and socket.

[0306] In a further aspect, a patient interface that can be used for the above-mentioned aspects can broadly include a nasal interface, comprising: a slender body, the slender body including at least one inner cavity extending at least partially through the body, the body being constructed to be connected to a gas flow source; one or more nasal prongs, the one or more nasal prongs extending from the body and being in fluid communication with the at least one inner cavity; and one or more hinges, the one or more hinges being pre-arranged to bend in a predetermined direction; wherein the one or more hinges are constructed to stabilize the position of the one or more nasal prongs on the patient's face when force is applied to the nasal interface.

[0307] The nasal interface may further include one or more facial pads configured to rest on the patient's face.

[0308] At least one of the one or more hinges may be positioned adjacent to or between the one or more nasal prongs.

[0309] At least one of the one or more hinges may be configured to bend inwardly toward the patient's face.

[0310] At least one of the one or more hinges may be configured to bend downwardly.

[0311] The nasal interface can have a generally gull-wing shape.

[0312] The nasal interface can have a wavy shape.

[0313] The nasal interface can have a curved space frame-like support structure.

[0314] The nasal interface can be curved in more than one dimension.

[0315] The nasal interface may include two separate sides connected by a bridge across the strap.

[0316] The one or more hinges may include one or more of: a notch, a variable cross-sectional area, a variable thickness, two or more materials with different flexibility, an elastic hinge constructed to be pre-stressed prior to application to the patient, a cylinder and pin, and / or a ball and socket.

[0317] In a further aspect, a patient interface that can be used for the above-mentioned aspects can broadly include a nasal interface, comprising: a slender body, the slender body including at least one inner cavity extending at least partially through the body, the body being constructed to be connected to a gas flow source; and one or more nasal prongs, the one or more nasal prongs being connected to the body and being in fluid communication with the at least one inner cavity; wherein the slender body has a shape that generally corresponds to the anatomical contour of the patient or the facial contour of a group of patients.

[0318] The group of patients may be one of premature infants, newborns, infants, toddlers or adults.

[0319] The tubular body may initially be ductile.

[0320] The shape of the tubular body may be set by a hardening process.

[0321] With reference to the various patient or user interfaces (including nasal interfaces) described above, in which a first nasal prong and a second nasal prong or nasal interface connecting element are noted as being configured to be fluidly connected, it should be understood that the description herein provides modifications in which a valve or 'bridge valve' may be implemented to control the flow or passage of gas between each nasal prong or nasal interface connecting element. In this way, the bias flow between the nasal prongs or nasal interface connecting elements may be controlled. For example, such a valve at the bridge may be used to support or prevent any flow or passage of gas between the nasal prongs, or the valve may be operated to allow gas to flow or pass between the nasal prongs. In this way, the bias flow of such an interface may be controlled.

[0322] The term "gull-wing" as used herein refers to a shape that includes two protrusions (or protrusion-like areas) and a depression (or depression-like area) between such protrusions, or includes two depressions (or depression-like areas) and a protrusion (or protrusion-like area) between such depressions, when viewed from a top or bottom view of the patient interface (e.g., when the sequence of corresponding protrusions or depressions is plotted as a line graph). Such protrusions or depressions may transition between each other in a relatively arcuate or curved manner. Optionally, such protrusions or depressions may be shaped or curved so as to substantially match or resemble the facial contour or shape of a typical user's face.

[0323] The term "wavy" as used in this specification refers to a shape that includes a plurality of protrusions (or protrusion-like areas) and depressions (or depression-like areas) when viewed from a top view or bottom view of the patient interface (e.g., when the order of corresponding protrusions or depressions is plotted as a line graph), and includes at least one depression (or depression-like area) correspondingly arranged between a pair of protrusions (or protrusion-like areas) or at least one protrusion (or protrusion-like area) or at least one depression (or depression-like area) correspondingly arranged between a pair of protrusions (or protrusion-like areas). Such protrusions or depressions may transition between each other in a relatively arcuate or curved manner. Optionally, such protrusions or depressions may be shaped or curved so as to substantially match or resemble the facial contour or shape of a typical user's face.

[0324] The term "space frame" as used in this specification is meant to refer to a structure that provides a substantially hollow scaffolding or support structure to which a gas delivery line or conduit can be connected or otherwise attached or supported on or to the scaffolding or support structure to deliver gas to a user or to a gas outlet of a patient interface (e.g., a nasal prong or a pair of nasal prongs).

[0325] Where reference is made to a "preformed" such a preformed element refers to an element that is manufactured or molded or constructed or assembled to provide a shape or configuration that is capable of providing a deformable response or a displaceable response in a preferred geometry.

[0326] Where reference is made to a "preferred geometry", this refers to a predetermined or preferred plane(s) or axis(s) of articulation or bending or deformation or displacement.

[0327] Where reference is made to "separation", this means that there is at least partial isolation or inhibition or absorption (or some other mode), preferably a mechanical mode but not limited to such a mode, in which forces or motions (or both) experienced by or applied to a first area or portion of the interface are at least minimized so as not to be fully transmitted to another area or portion of the interface.

[0328] The term "comprising" as used in this specification means "consisting at least in part of..." When interpreting each statement in this specification containing the term "comprising", there may also be features other than the one or those features following the term. Related terms such as "comprise and comprises" are to be interpreted in the same manner.

[0329] The present invention may also be broadly described as consisting of the parts, elements and features individually or collectively referred to or specified in the specification of the present application, as well as any or all combinations of any two or more of said parts, elements or features, and when specific integers having known equivalents in the art to which the present invention relates are mentioned herein, such known equivalents are deemed to be incorporated herein as if individually listed.

[0330] The present invention resides in the foregoing, and also contemplates a variety of configurations, only examples of which are given below. BRIEF DESCRIPTION OF THE DRAWINGS

[0331] Preferred embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:

[0332] Figure 1 One embodiment of a patient interface is presented.

[0333] Figure 2 Alternative embodiments of patient interfaces are presented.

[0334] Figure 3 Embodiments of a patient interface when provided in conjunction with a diverter valve are shown, and corresponding additional conduits are in fluid communication with a gas source and downstream devices.

[0335] Figure 4 A close up view of the diverter valve is shown.

[0336] Figure 5 yes Figure 4, showing how the blade of this valve can be redirected to switch an associated conduit supplied with gas from a gas source G and to switch an associated conduit arranged in fluid communication with a downstream device D.

[0337] Figure 6 In a decomposed state Figure 4 FIG. 1 is a diagram of a steering valve showing how the vane may operate with the housing or body of the steering valve.

[0338] Figure 7 The pressure measurement arrangement is shown.

[0339] Figure 8 An alternative nasal interface to patient interface is demonstrated.

[0340] Fig. 9 Shown in more detail Figure 8 interface.

[0341] Fig.10 Shows what it looks like when worn by a user Fig. 9 interface.

[0342] Fig.11 Demonstrated the combination Fig. 9 The interface system.

[0343] Fig.12 Shown Figure 8 and Fig. 9 Further alternatives to the interface.

[0344] Fig.13 Shown Fig.12 Another view of the interface.

[0345] Fig.14 Demonstrated the combination Fig.12 The interface system.

[0346] FIG. 15A to FIG. 15D Embodiments of attachment mechanisms for securing a user interface and / or a user interface tube to a patient are presented.

[0347] Fig.16 Embodiments of a securing system comprising a two-part releasable attachment or connection arrangement are presented.

[0348] Fig.17 Another embodiment of a securement system comprising a two-part releasable attachment or connection arrangement is presented.

[0349] Fig.18 Another embodiment of a securement system comprising a two-part releasable attachment or connection arrangement is presented.

[0350] FIG. 19A to FIG. 19BEmbodiments of securing structures configured to secure a pressure lumen and / or a surfactant lumen to a patient's face are presented.

[0351] FIG. 20A to FIG. 20C Embodiments of attachment mechanisms including dynamic interfaces are presented.

[0352] FIG. 21A to FIG. 21C Another embodiment of an attachment mechanism including a dynamic interface is presented.

[0353] Fig. 22 Another embodiment of an attachment mechanism including a dynamic interface is presented. DETAILED DESCRIPTION

[0354] The following description is made with reference to the accompanying drawings.

[0355] The present disclosure relates to a system and / or apparatus and / or method for providing gas therapy to a user. Specifically, but not limited to, applying gas therapy using a patient interface that has the ability to direct or deliver a flow of gas from a source to one nostril of the user as an inspiratory flow and to collect and direct a flow of gas from the other nostril of the user as an expiratory flow.

[0356] Advantageously, such patient interfaces and / or systems and / or methods may facilitate one or more of the following:

[0357] Clear and reduce airway dead space (i.e., the user's physiological airway dead space),

[0358] reducing or substantially eliminating dead space in the patient interface (i.e., structural dead space in the interface due to internal geometry or the flow path of gas through the patient interface),

[0359] facilitating detection of gas delivery to a user or facilitating detection of intended gas therapy being delivered or provided to a user,

[0360] · Alternative modes of delivering or providing CPAP gas therapy to a user,

[0361] a mechanism for delivering medication to the user's airway,

[0362] The ability to provide as a single patient interface a first mode or gas therapy to a user in which two nasal interface connection elements are used to deliver a gas flow to the user / patient, and then in another mode, deliver breathing gases to the user / patient via a sole or dedicated nasal connection element to a first of the user / patient's nares, with the option of providing a bias flow between the inspiratory nasal interface connection element and the second nasal interface connection element.

[0363] References to dead space in this specification may refer to the user's physiological (ie, their airway) dead space or to dead space that may exist in a patient interface. It is desirable to reduce dead space in this context of both user dead space and patient interfaces that provide specific gas therapy.

[0364] Although the patient interface, system and method disclosed herein may be specifically related to infant users, it will be understood that the end user (or patient) may vary from an infant user to a pediatric user to an adult user. In this way, various components of the patient interface (such as a catheter or nasal interface connection component or other element) or components or devices provided as part of the system or for providing a specific gas therapy intended method to provide appropriate gas flow, gas pressure, sealing force (for example, an adult user may be able to wear a patient interface or a suitable interface holding system more comfortably relative to a younger user, thereby providing a higher or greater sealing force or a higher gas pressure or a higher gas flow). It will also be understood that the larger gas flow or pressure that may be required by an older user may not be suitable for a younger user, so the specific control or demand for the components or devices in the patient interface or system may be different. For example, delivering a larger flow rate of gas to a user may require a catheter with a larger hole, while for a younger user, the flow rate may be smaller, so a catheter with a smaller hole may be suitable, including but not limited to considering the flow resistance (RTF) of the catheter to be used. Each of these types of considerations can be considered according to the user's requirements.

[0365] The systems, devices or methods described above may be further modified to control the positive airway pressure type gas therapy to be provided to the user. For example, a nasal interface connection component provided as part of an expiratory line or conduit configured to be in fluid communication with the expiratory flow can be operated to provide a closed medical breathing circuit.

[0366] The systems and / or devices and / or methods of the present disclosure also enable a gas source to be selectively provided or delivered to one of the user's nostrils via a first nasal interface connection component, wherein a collection of gas flows is selectively provided or received from another nostril of the user via a second nasal interface connection component.

[0367] The systems and / or devices and / or methods of the present disclosure also enable selective control of gas bias flow directed to one of a pair of nasal interface connection components of a patient interface. For example, in a bridge region of such a patient interface, a valve (referred to herein as a 'bridge valve') is operable to adjustably control fluid communication between gas paths of each of the pair of nasal interface connection components.

[0368] Physiological (also called anatomical) dead space is the portion of the airway that is shared by the inspiratory and expiratory flow paths and can therefore potentially fill with CO2 at the end of the expiratory phase so that this CO2 will then be inhaled during the next inspiratory phase or the next expiratory portion of breathing.

[0369] Structural dead space can be reduced by mechanical design, that is, by reducing the portion of the interface that is shared by the inspiratory and expiratory flow paths. In various embodiments, a patient interface as disclosed herein can eliminate shared portions entirely. Specifically, a conventional sealed cannula will have dead space in both the nasal prongs and the "bridge" (the gas flow path that connects the nasal prongs to each other). As described herein, a patient interface can be constructed to have no gas flow path in the bridge. In addition, when the patient interface described herein provides a unidirectional (and provided to a single nostril of the user) gas flow, there is no shared space in the nasal prongs.

[0370] Patient interfaces and gas therapies (e.g., respiratory gas therapies) can also effectively reduce anatomical dead space by managing gas flow (e.g., higher bias flow rates or jet action of conventional flow driver interfaces). This type of patient interface can reduce anatomical dead space by operating to effectively force all bias flow through the patient's airway, thereby "flushing" CO2 during and after the expiratory phase (as long as the bias flow rate is high enough to meet peak inspiratory demands).

[0371] Additional disclosure and concepts for suitable systems and / or devices and / or methods for implementing the above are provided below.

[0372] Bias flow is referred to as the minimum gas flow rate through the patient interface during both the inhalation phase and the exhalation phase. For conventional interfaces, during the exhalation phase, the bias flow goes directly through the interface and does not reach the patient. However, with the patient interface described herein, 100% bias flow can be delivered to the patient during both breathing phases.

[0373] The bias gas flow rate, or bias flow rate, is typically approximately constant for a given pressure setting and should be at or near the peak inspiratory demand (the flow rate that will support PIP) (which is the peak inspiratory pressure, the highest negative pressure applied to the lungs during inspiration) to ensure positive pressure throughout the respiratory cycle. That is, if the bias flow rate is too low, then there will be a negative pressure in the gas flow at the peak of inspiration.

[0374] With conventional interfaces, excess bias flow (above peak inspiratory demand) has little effect on the patient. However, with the patient interface described herein, excess bias flow may increase dead space washout, which can reduce respiratory rate. Lower respiratory rates can also reduce peak inspiratory demand, potentially reducing the bias flow rate required to maintain positive pressure.

[0375] On the other hand, a reduced bias flow rate (still meeting peak inspiratory demands) may be beneficial in reducing the likelihood of damaging the patient's airway and, in the case of oxygen therapy, reducing the likelihood of retinopathy of prematurity due to oxygen toxicity.

[0376] In one embodiment, a patient interface 1 is provided, comprising a first nasal interface connection component 2 configured to be in fluid communication with a first nostril (not shown) of a user and an associated first conduit 3 provided for independent / dedicated fluid connection with the first nasal interface connection component 2; and a second nasal interface connection component 4 configured to be in fluid communication with a second nostril (not shown) of a user and an associated second conduit 5 provided for independent / dedicated fluid connection with the second nasal interface connection component 4. In this arrangement, the only inspiratory line or conduit configured to deliver an inspiratory gas flow from a gas source G (not shown) to one nostril of a user is either: a) the first nasal interface connection component 2 and the associated first conduit 3, or b) the second nasal interface connection component 4 and the associated second conduit 5. In this arrangement, the only expiratory line or conduit configured to receive gas from the other nostril of the user is the other of the first nasal interface connection component 2 and the associated first conduit 3 or the second nasal interface connection component 4 and the associated second conduit 5. Such an embodiment may, for example, be Figure 1 Type shown.

[0377] In another embodiment, such a patient interface may be, for example Figures 8 to 10 As shown in either or when used for example Fig.11 or in another embodiment, such as Figure 12 to Figure 13 As shown in either or when used for example Fig.14 The type of time in the system shown.

[0378] Figures 8 to 10A portion of a patient interface including a pair of nasal interface connection components 116, 118 is shown. The nasal interface connection components extend from the body portion 136, from the relatively flexible section 126. The nasal interface connection components are shown without sealing elements for providing sealing capabilities with the user's nares, but it will be appreciated that there are various sealing systems that can be used to modify such components as described elsewhere in this specification. The nasal interface connection components 116, 118 are each equipped with an associated conduit 112, 142. The nasal interface connection structures 116 and 118 can be large enough to form a seal with the nostrils. Alternatively, the structures 116, 118 can include other sealing structures defined herein. For the purposes of this embodiment, it is not necessary to specify which associated conduit is fluidly connected to which nasal interface connection component (as it may be a configuration of the design of the interface itself), however it will be appreciated that each of the associated conduits 112, 142 is configured to be in direct (and dedicated / unique) fluid communication with one nasal interface connection component each. In this manner, the housing 138 can act as a partitioned manifold to ensure a separate and unique fluid connection between each associated conduit 112, 142 and the corresponding nasal interface connection component 116, 118. Alternatively, the housing 138 can be used to provide a relatively solid body that is configured to guide the individual conduits 112, 142 to the nasal interface connection components to which they are respectively fluidly connected. In the illustrated embodiment, the associated conduits 112, 142 are shown one behind the other, however, side-by-side type arrangements are also contemplated (see, e.g., Figure 12 to Figure 13 A port 144 may also optionally be provided, which may allow, for example, a suitable sensor, detector (as described, for example, elsewhere in this specification) to be placed in fluid communication with one or the other or possibly both of the associated conduits 112, 142 or in close proximity to the nasal interface connection components 116, 118 for pressure or flow sensing or detection purposes.

[0379] Fig. 9 Shown in more detail Figure 8of patient interfaces. Associated conduits 112, 142 are shown extending generally upwardly away from the nasal interface connection component. A headrest or support type block 334 is also shown. A diverter valve 9 may be incorporated into this block 334, as described elsewhere in this specification. Such a diverter valve is operable to switch an inspiratory gas flow from a source G to either of the associated conduits 112, 142 so that the inspiratory gas flow is then selectively supplied to a single nasal interface connection component (e.g., either of the nasal interface connection components 116 or 118). Such a diverter valve is then also operable to selectively cause one of the nasal interface connection components and its associated conduit to operate to receive an expiratory gas flow from the user and direct that flow to a downstream device (D) (not shown). For purposes of this embodiment, a source of the inspiratory gas flow may be directed from a supply conduit via lumen 21 (and then into block 334 and the diverter valve), while an expiratory gas flow is directed through an expiratory conduit via lumen 230. Identified as Fig. 9 Additional conduits and lumens in item 156 may be take-offs for pressure measurement purposes.

[0380] Fig.10 Shows what it looks like when worn by a user Figure 8 , Fig. 9 The patient interface 100 of FIG. 1 is shown in this case by the headband 150. It will be appreciated that other forms of retention as described herein may be used in combination with the interface 100.

[0381] Fig.11 A patient interface 100 is shown, such as Figures 8 to 10The patient interface for the system shown. A flow generator 18 is shown, which is used to provide a flow of a gas source G to the humidification chamber 10 via an inlet 16 for regulation and then exit at an outlet 12. The humidification chamber 10 includes a humidifying fluid (e.g., water). Heat is provided to the humidification chamber 10 via a heater base HB. An inspiratory branch conduit 21 can be used to transmit regulated gas to the interface 100. The conduit 21 can optionally be equipped with a heating system, such as a heater 20, which can be controlled according to the condition requirements of the gas for delivery to the interface 100 worn by the patient P. The inspiratory gas is provided to the patient P via the dedicated associated conduit and nasal interface connection components described herein. The expiratory gas flow is then directed away from the patient via a dedicated nasal interface connection component and an associated conduit that are configured to be in fluid communication with the expiratory branch conduit 230. The expiratory branch conduit 230 is configured to be in communication with a downstream device D, which in this example can be a bubbler 234. Bubble 234 includes a gas inlet 252 and an extension tube or extension piece to reach below water level 236 of water 238. Depending on the depth of the extension tube or extension piece, the effective back pressure on the closed system can be controlled as required for the breathing gas therapy to be provided to patient P.

[0382] Fig.12 Demonstrated concept and Figures 8 to 10 142 are arranged in a side-by-side configuration. The same type of fluid connection is provided between the associated conduits and the nasal interface connection components 116, 118 (i.e., each is fluidly separate). Such separation may be provided by a divider (not shown) within the body or housing. The arm labeled RS is configured to receive a suitable retention system, such as a headband type arrangement. Various output devices, such as 410 and 470, are provided for sensors or other detectors for pressure or flow type sensing or detection purposes (as described elsewhere in this specification). Fig.13 Shown from different angles Fig.12 interface 200.

[0383] In various embodiments, for example Fig.12 and Fig.13 As shown in , an output device or port such as output device 410 can be used as a port for introducing a drug into the gas stream being delivered to the user. Optionally, this drug can be an aerosolized drug, such as an aerosolized surfactant, or can be any other suitable drug that can be introduced into the gas stream for delivery to or into the airway of the user.

[0384] In various embodiments, where a port such as 410 is provided for a patient interface, such a port 410 can be used to administer or deliver a drug into a gas stream being delivered to a user or patient. For example, the drug can be atomized or otherwise suitably provided for administration to a user or patient's airway.

[0385] The drug can be provided into the gas flow being supplied to the user or patient as an inspiratory flow. In one embodiment, a drug delivery port (such as Fig.12 , Fig.13 The port 410 shown in FIG. 4A can be in fluid connection or communication with one or both of the nasal interface connection elements 116 , 118 .

[0386] Where the drug delivery port is configured to be in fluid connection or communication with a single nasal interface connection element, the diverter valve will need to be operated or properly matched to provide the gas supply source to the nasal interface connection element associated with the drug delivery port, thereby ensuring that the drug is delivered to the gas flow being delivered to the user or patient as an inspiratory flow. Alternatively, where the drug delivery port is configured to be in fluid connection or communication with two (or both) nasal interface connection elements, the drug diverter valve will need to be operated or properly matched to provide the drug that can be administered via a port (such as 410) to the nasal interface connection element or associated line or conduit being supplied by the gas supply source to the nasal interface connection element, thereby ensuring that the drug is delivered to the gas flow being delivered to the user or patient as an inspiratory flow.

[0387] The drug can be provided into the gas flow being supplied to the nasal interface connection element selected as the inspiratory nasal interface connection element. This selection can be achieved by using a diverter valve upstream of the inspiratory nasal interface connection element.

[0388] In the event that a particular one of a pair of nasal interface connection elements of a patient interface is selected as the inhalation nasal interface connection element by a diverter valve, the diverter valve can be suitably associated with or connected to a mechanism associated with a medication port to direct medication administered via the port to the selected inhalation nasal interface connection element.

[0389] Alternatively, a valve or diverter valve or selector may be operably adjustable at the port or elsewhere on the patient interface for selecting one of the nasal interface connection elements, or one of the associated conduit and nasal interface connection elements to fluidly connect with the port to receive medication administered via the port. This valve or diverter valve or selector allows a line or conduit connected to the port to mate or fluidly couple with the nasal interface connection element selected as the inspiratory line or conduit for delivering medication to the user or patient via the port.

[0390] For example, Fig.12and Fig.13 The port 410 shown in FIG. 4B provides a line or conduit or channel for directing medication that may be administered into the port 410 .

[0391] In one embodiment, the line or conduit extending from port 410 can provide a dedicated or sole fluid connection or communication with a single nasal interface connection element (e.g., one of nasal interface connection elements 116 or 118). The nasal interface connection element that is in fluid connection or communication with the line or conduit from drug delivery port 410 is the inspiratory nasal interface connection element or its associated conduit. In this way, the drug delivered via port 410 is directed to the gas flow that is being directed for delivery to a user or patient.

[0392] In another embodiment, a line or conduit extending from port 410 can provide selective fluid connection or communication with each nasal interface connection element (e.g., one of nasal interface connection elements 116 or 118 can be selected for delivery of medication). The nasal interface connection element that is in fluid connection or communication with the line or conduit from the medication delivery port 410 is the inspiratory nasal interface connection element or its associated conduit. In this way, medication delivered via port 410 can be selectively directed to a gas stream that is directed for delivery to a user or patient.

[0393] According to the above embodiments, such a valve or diverter valve or selector that allows the line or conduit connected to the port to match or fluidically connect with the nasal interface connection element selected as the inhalation line or conduit for delivering the drug to the user or patient via the port may be a manually adjustable valve, or may be automatically adjusted according to the associated line or conduit and the nasal interface connection element to supply the gas source to the associated line or conduit being selected as the inhalation line or conduit and the inhalation nasal interface connection element. That is, which nasal interface connection element or its associated conduit or line to receive the delivery of the drug may be selected manually or automatically in response to the selection of the diverter valve.

[0394] Fig.14 Shown with Fig.11 A further system 1000 is similarly arranged, for example wherein an indication interface 200 is utilized. The interface 200 is shown on a patient, the interface receiving an inspiratory gas flow G via an inspiratory conduit 60, and the expiratory gas flow is directed from the interface to a bubbler device 70 via an expiratory conduit 40. A diverter valve 9 is provided to allow selective determination of the configuration of the conduit and nasal interface connection components to be provided as an inspiratory line or conduit or an expiratory line or conduit. A humidifier system 30 is provided, the humidifier system providing a chamber located atop a heater base, the chamber being supplied with a gas flow source, for example, from a hospital or other supply source 2000.

[0395] In each of the interfaces 100 or 200 described above, it will be appreciated that one or more of the following may be provided:

[0396] A bridge valve type arrangement can be provided to adjust the bias flow,

[0397] A diverter valve may be provided to allow switching of the nasal interface connection component for use in an inspiratory configuration or an expiratory configuration,

[0398] Different retention systems for retaining the interface on the patient may be used,

[0399] A system for holding a supply tube may be provided in conjunction with an interface,

[0400] The nasal interface connection component may have no nasal sealing capability or may not have no nasal sealing capability.

[0401] Further, in each of the embodiments of the interfaces 100 and 200 described above, the inhalation and exhalation gas conduits will extend downward from the forehead toward the nose. The conduits will be directly connected to the nasal prongs or may be connected to the nasal prongs through a manifold. The manifold may include a partition between the inhalation nasal interface connection component and the exhalation nasal interface connection component, so that all inhalation gases (i.e., fresh gas) are delivered through one such component (e.g., nasal prongs) and all exhaled gases from the user are directed through the exhalation component (e.g., exhalation nasal prongs) and directed to the exhalation gas conduit. The nasal interface connection component may be a nasal prong and may include a sealing structure, such as a ball end or a pillow or cascade / nested barbs, to facilitate sealing with each nostril. The nasal prongs may alternatively be in the form of an inflatable nasal prong that can be inflated to seal around the nostrils.

[0402] In another embodiment, a system including a medical breathing circuit may incorporate the above-described patient interface 1 as a gas therapy delivery device. This system will be provided with a gas source G. The gas source may be conditioned, such as optionally heated and / or humidified.

[0403] Humidification can be performed in a humidification chamber disposed upstream of the inspiratory line or catheter. For example, it can be a chamber configured to contain or hold a humidification fluid (e.g., water), the chamber comprising a heating base configured to transfer heat to the humidification fluid. A gas stream source G can be transmitted to the chamber, regulated, and then further transmitted to the inspiratory line or catheter of the patient interface or system described herein. The heating of the gas source G can be provided by a humidification chamber, or can be provided by a controllably heated catheter provided as part of the patient interface 1 or as part of a system that can operate with the patient interface 1.

[0404] The regulated gas may then be provided to the user via the gas delivery pathway. The gas delivery pathway may be connectable to an associated conduit (e.g., in the form of a ventilator) provided as part of an inspiratory line or conduit for providing inspiratory gas to the user. Figure 1 The associated catheter 3) is shown in the configuration.

[0405] The system may be configured to allow selective connection of a gas source G to an associated first conduit 3 or second conduit 5, which is arranged in fluid communication with their respective nasal interface components 2, 4. This means that either of the nasal interface connection components 2, 4 may be selected for delivering inspiratory gas. Figure 1 Nasal interface connection component 2 is shown as an inspiratory line or catheter gas path in use, while nasal interface connection component 4 is an expiratory line or catheter gas path.

[0406] The selective connection may facilitate switching the supply of source gas G from one of the associated first conduits 3 or second conduits 5, thereby enabling switching of the nasal interface connection component to be operated as an inspiratory gas provider for the user in use. The selective connection will also allow facilitating switching of the associated first conduit 3 or second conduit 5 (and the nasal interface connection component connected thereto) between operating as an inspiratory line or conduit or an expiratory line or conduit.

[0407] Figure 1 An exemplary patient interface is shown in which a nasal interface connection component 2 and its associated conduit 3 operate as part of an inspiratory line or conduit, while an expiratory line or conduit is provided by a nasal interface connection component 4 and its associated conduit 5. G indicates that a flow of gas (optionally regulated) provided from a source is provided to the user interface. Figure 1 The arrows in the figure indicate the direction of flow of gas through the associated conduits and nasal interface connection components when the patient interface 1 is constructed without any fluid communication between the flow paths of the pair of nasal interface connection components. This can be compared, for example, to the provision of a bridge valve 6 in the bridge region of the interface. Figure 2 In comparison, the ability to provide fluid communication between the various nasal interface connection components is provided.

[0408] Figures 1 to 3 Also shown are component parts of the interface 1 which may operate with a suitable retention system.For example, a pair of laterally extending wings 8 may be provided for implementing a two-part releasable connection arrangement or securing system as described elsewhere in this specification.

[0409] In another embodiment, a method of providing gas therapy to a user includes delivering gas from a source to the user via a single inspiratory line or conduit and receiving gas from the user via a single expiratory line or conduit, wherein a first nasal interface connection component (configurable to engage with a first nostril of the user) is operable to provide delivery of expiratory gas to the user, and a second nasal interface connection component (configurable to engage with a second nostril of the user) is operable to provide receipt of expiratory gas from the user. In this method of providing gas therapy, the gas therapy may be positive airway pressure (PAP) therapy.

[0410] The above-described apparatus, systems, and methods facilitate delivery of gas to a user, wherein the delivered gas (i.e., inspiratory gas from an inspiratory line or catheter) provides a dedicated delivery point to the user's airway (e.g., via a single nostril), rather than allowing the delivered gas to pass through the interface from the inlet of the interface to the outlet of the interface and avoid having the delivered gas reach the user. This configuration can help reduce dead space in the patient interface itself, and can provide a detection system to determine if there may be a loss of gas therapy being provided to the user.

[0411] The first nasal interface component can have any suitable arrangement, shape, or size, but is configured to provide an interface with a first nostril of a user, wherein the interface is fully or partially inserted into the nostril. Similarly, the second nasal interface component can have any suitable arrangement, shape, or size, but is configured to provide an interface with a second nostril of a user, wherein the interface is fully or partially inserted into the nostril.

[0412] One or both of the first nasal interface component 2 and the second nasal interface component 4 can be configured or have been configured to substantially sealingly engage or interface with a nostril of a user to which each nasal interface connection component is to be provided. For example, a first nasal interface connection component can be provided for sealing engagement with a first nostril of a user, while a second nasal interface connection component can be provided for sealing engagement with a second nostril of a user.

[0413] exist Figures 1 to 3 In the figure, the nasal interface connection component is shown as a nasal prong of a nasal cannula, which has a wider portion that lowers the neck of the nasal prong so that the nasal prong can be substantially sealed with the user's nostrils.

[0414] In this way, substantial sealing of the nasal interface connection portions (first and second) with the user's nostrils (first and second) can provide a patient interface, system, or method for providing gas therapy to the user, and the provision of gas therapy can be controlled.

[0415] For example, a substantial seal with the user's nostrils may be achieved, which in turn allows for delivery of specific gas therapies to the user, such as CPAP (e.g., a bubble CPAP device), BiPAP, NiPPV, SiPAP (e.g., providing a flow driver for CPAP) for controlled delivery of gas to the user. Controlled delivery of gas to the user may utilize an apparatus associated with an expiratory line or conduit for controlling the flow of gas that a user may provide to an expiratory line or conduit of such a patient interface, a system including such a patient interface, or a method of delivering gas therapy to a user.

[0416] There are a variety of mechanisms or systems that can be used to provide nasal interface connection components with nasal sealing capabilities. For example, a sealing member can be provided as part of each nasal interface connection component. Such a sealing member can take the form of a seal or arrangement that can be operated to substantially provide a seal once in place with the user's nostrils (e.g., nasal pillows or other inflatable arrangements), or the nasal interface connection components can be suitably shaped so as to provide a seal with the user's nostril walls once substantially inserted into the user's nostrils.

[0417] However, it will be appreciated that other seal or sealing member arrangements may be provided for the nasal interface connection component. This may take the form of a physical shape or form or arrangement of a plug-type sealing system, or may take the form of an arrangement operable to provide a seal with the user's nares in use (e.g., an inflatable pillow system).

[0418] Where the nasal interface connection component is, for example, a nasal prong (e.g., the nasal prong of a nasal cannula-type patient interface), then the nasal prong will have a seal or sealing member. Alternatively, where the nasal interface connection component is, for example, part of a nasal mask-type patient interface, then the portion for engaging with each of the user's nostrils will be provided with a suitable seal or sealing member.

[0419] In a further alternative, other forms of nasal interface-connected patient interfaces may be provided that include a partition for providing a partition between a first nostril (e.g., left nostril) of a user and a second nostril (e.g., right nostril) of the user, the partition facilitating controlled delivery of a gas source to one nostril of the user as an exhaled gas flow and facilitating controlled receipt of gas from another nostril of the user as an exhaled gas flow. See, for example, Figures 8 to 14 Patient interface (and associated system) shown. In this regard, the nasal interface connection structures 116 and 118 can be large enough to form a seal with the nostrils. Alternatively, the structures 116, 118 can include other sealing structures defined herein.

[0420] The patient interface may form a sealed gas pathway between the gas source and the first nostril and form a sealed gas pathway from the second nostril to further components.

[0421] Similarly, providing a patient interface that facilitates sealing of an inspiratory line or tube with a first nostril of a user and an expiratory line or tube with a second nostril of the user can make the interface suitable for CPAP and other related pressure-controlled gas therapies.

[0422] While the nasal interface connection component is considered to include a seal, the sealing capability may be sufficient such that approximately 90% of the user's nostril (cross-section) is occupied by the nasal interface connection component.

[0423] Further examples include any shape of nasal prongs that can seal each nostril individually, such as expanded nasal prongs, Christmas tree shaped barbs, multiple cascading barbs, trapezoidal pillows on a stem type arrangement, or double wall pillows on a stem type arrangement, or even high flow therapeutic nasal prongs. Other types of patient interfaces can be modified to seal each nostril individually, such as dual chamber nasal pillows. It will be appreciated that the nasal interface connection component can be large enough to form a seal with the nostrils. Alternatively, the structure can include other sealing structures defined herein.

[0424] In various embodiments, the patient interface can be configured to include a divider 7 (which can be a mechanical / physical divider, for example) between each of the first nasal interface connection component and the second nasal interface connection component.

[0425] When in a nasal cannula type patient interface, the separator 7 may be, for example, a solid bridging region. Figure 1 shown.

[0426] Such a divider provides a mechanical fluid disconnect between the fluid flow path of the first nasal interface connection component and the fluid flow path of the second nasal interface connection component. In this way, the fluid flow path of each nasal interface connection component can be kept separate and / or reserved for dedicated inhalation operation or exhalation operation.

[0427] In an alternative configuration, the partition 7 can be configured to provide an adjustable or controllable mechanical fluid connection and / or disconnection of the fluid flow paths of the first nasal interface connection component and the second nasal interface connection component. For example, the partition can include or can be a valve, such as a valve provided by Figure 26. Valve 6 can be any suitable arrangement that allows for controlled gas flow between fluid flow paths of the nasal interface connection components. A gate valve, butterfly valve, or other suitably constructed valve can be used. Such a controllable or adjustable divider allows for adjustment of the bias flow of a gas source to the first nasal interface component and / or the second nasal interface component (depending on which nasal interface component is selected or provided as the inspiratory side and which nasal interface component is selected or provided as the expiratory side of the patient interface).

[0428] Providing a partition 7 or division between the inspiratory flow path and the expiratory flow path can provide benefits for many end users and related to gas therapy, such as but not limited to:

[0429] Allow gas flow to be unidirectional so that gas flowing into one side of the patient interface must flow through the user's airway (e.g., into the user's airway via an inspiratory line or tube) to reach the other side of the interface (e.g., out of the user's airway via an expiratory line or tube).

[0430] Valves in the bridge section (i.e., bridge valves, such as Figure 2 6) can be optionally disposed between the pair of nasal interface connection components (e.g., between the first nasal prong and the second nasal prong), such a bridging valve can allow the patient interface to switch between different modes, such as one-way flow (e.g., a single dedicated / only inspiratory nasal interface connection component, and toward a more traditional CPAP flow by opening the bridging valve and allowing some inspiratory line or catheter gas flow to reach the other nasal interface connection component, such as the nasal interface connection component being operable as a single dedicated / only expiratory nasal interface connection component in the previous mode).

[0431] In various embodiments, the diverter valve 9 can be implemented to fluidly connect the gas flow source G to one of the following: the first conduit 3 and the first nasal interface component 2, or the second conduit 5 and the second nasal interface component 4, to provide an inspiratory line or conduit. Similarly, the diverter valve 9, when implemented, can fluidly connect the gas received from one of the first nasal interface component 2 or the second nasal interface component 4 via the associated first conduit 3 or second conduit 5 to provide an expiratory line or conduit. The expiratory line or conduit can deliver the expiratory gas flow to a device D (not shown) capable of controlling the expiratory gas, so as to provide auxiliary control of the gas therapy provided to the user.

[0432] For example, the device may be a bubble CPAP type arrangement that creates back pressure in the gas provided to the user in a closed system.Alternatively or additionally, the diverter valve 9 may be connected to a port for a gas source or provide for the return of exhaled gas to said port.

[0433] In alternative embodiments, the diverter valve 9 can be implemented to operably divert the gas source to one of the first conduit and the first nasal interface component (3, 2) or the second conduit and the second nasal interface component (5, 4), thereby constructing a patient interface 1, system or method for delivering gas therapy to a user by determining the nasal interface connection component to be used for the inspiratory line or conduit. Similarly, the diverter valve 9, when implemented, can be operated to fluidly connect the gas received from the user via the first nasal interface component and the first conduit (2, 3) or the second nasal interface component (and one of the second conduits (5, 4) when provided as an expiratory line or conduit). The expiratory line or conduit can be arranged to be in fluid communication with a device D (not shown) capable of controlling expiratory gas to provide auxiliary control of the gas therapy provided to the user, for example, the device can be a bubble CPAP type arrangement that generates back pressure for the gas provided to the user in a closed system.

[0434] In the case where a diverter valve 9 is provided as part of a patient interface 1 (e.g., a component) or system or as part of a method for providing gas therapy to a user, such a diverter valve 9 can facilitate selectively determining or directing a gas source to one of the first conduit and the first nasal interface component or the second conduit and the second nasal interface component to operate as an inspiratory line or conduit, and selectively allowing the other of the first conduit and the first nasal interface component or the second conduit and the second nasal interface component to operate as an expiratory line or conduit.

[0435] In the manner described above, the steering valve 9 can be controlled or adjusted to selectively determine:

[0436] the first conduit or the second conduit serving as the inhalation line or conduit for delivering a gas source to the first nasal interface component or the second nasal interface component, and

[0437] The first conduit or the second conduit serves as the exhalation line or conduit for subsequently receiving gas from the first nasal interface component or the second nasal interface component.

[0438] For example, such a diverter valve 9 may be adjusted manually (e.g., by medical personnel), or may be automatically adjusted or controlled based on inputs such as user or patient parameter inputs, or based on expected changes in the nostril to which inspiratory gas will be provided (and subsequently also the nostril for expiratory flow).

[0439] Thus, adjustment or control of the diverter valve 9 may be operated to synchronize with the user's nasal cycle (the user's natural alternation of increased or decreased obstruction between the user's nostrils), or to provide relief to the user by switching or alternating which nostril is being used to receive the inspiratory and expiratory airflows.

[0440] Advantageously, the diverter valve 9 fluidly connects the expiratory line or conduit with a downstream device D (not shown). For example, the downstream device may be those including, but not limited to, a CPAP bubbler or other device that creates a back pressure of gas in the expiratory line or conduit.

[0441] The diverter valve 9 can fluidly connect the associated conduit (operable as an inspiratory and expiratory line or conduit) to either of the nasal prongs of the nasal interface connection component, depending on the position of the diverter valve. Specifically, a switch or other actuation mechanism can be moved, for example, between two settings (e.g., "R" and "L" for indicating that the exhalation flow is directed to the left or right nasal prong, respectively).

[0442] For example, Figure 3 The diverter valve 9 is shown configured such that the conduit in which the inspiratory gas flow is received is selected as "L". Figure 4 It's the same arrangement. Figure 5 and Figure 6 One form of the diverter valve 9 is shown when disassembled, showing the internal vane 10 which solely directs the flow of gas from a gas source G to be directed to an associated conduit for use as an inspiratory line or duct, while isolating another associated conduit to be used as an expiratory line or duct and for directing expiratory gas to a downstream device D (not shown). Figure 5 9 is a cross section of a diverter valve 9 showing how a blade 10 can be reoriented within the housing of the diverter valve depending on the use of an associated conduit switch as an inspiratory and expiratory line or conduit. In addition, those skilled in the art will appreciate that any suitable diverter valve known in the art can be used in place of the diverter valve shown.

[0443] Figure 6 Also shown is an optional additional embodiment of a pressure relief device 11 provided on the gas source line or conduit. Such a pressure relief device may be provided as a user safety mechanism to prevent over-pressurization of the user's airway.

[0444] The manually actuated steering valve 9 is for example Figures 3 to 6 Shown.

[0445] Automatic variations of the diverter valve 9 may be actuated using a solenoid or similar component; such a diverter valve may also be actuated manually (eg, when a caregiver pushes a user interface button) or may be actuated automatically based on time or pressure.

[0446] The diverter valve 9 may be used to synchronize with the user's nasal cycle, to prevent asymmetric development of the unossified airway of a neonate, or to simply improve user comfort.

[0447] According to various embodiments described herein, the patient interfaces, systems and methods may additionally incorporate a detector of pressure or gas flow in the expiratory line or conduit. Such detection may be used as an indicator of a leak or loss of gas therapy provided to the user.

[0448] The detector may be a sensor, such as a pressure sensor or a flow sensor, disposed on an expiratory line or duct (or on an inspiratory line or duct or on both expiratory and inspiratory lines or ducts). Such one or more sensors may provide a signal in response to the pressure or gas flow in the expiratory or inspiratory line or duct. Optionally, the gas in the expiratory line or duct may be sent to one or more of the following: a carbon dioxide analyzer, an oxygen sensor or analyzer, a nitrogen or nitrous oxide sensor or detector, or a gas sample from the expiratory line or duct may be sent to one or more of these sensing or detection or analysis devices via a separate sampling line or duct fluidly connected to the expiratory line or duct.

[0449] Optionally, the expiratory line or conduit may include sensors for sensing, detecting or analyzing one or more of: humidity, temperature, pressure, flow, or a gas sample from the expiratory line or conduit may be sent or directed to one or more of these sensors.

[0450] The detectors and the detection or signals generated by the sensors may be used in association with or provided as indicators of a leak or loss of gas therapy provided to the user. For example, when the gas flow or gas pressure is above or below a threshold gas flow or threshold gas pressure (depending on whether the measured / sensed / detected flow or pressure is of an inspiratory line or conduit or an expiratory line or conduit), the detected or sensed gas flow or pressure, or signals representative of these conditions, may provide an indication of a leak or loss of gas therapy provided to the user.

[0451] A detector may be provided where one or both of the first and second conduits are non-self-supporting or collapsible in the absence of a minimum gas pressure within these conduits or when the gas pressure within these conduits is below a predetermined threshold, such as a conduit of an expiratory line or catheter. For example, if the gas pressure is below a threshold gas pressure, the conduit may collapse, thereby providing a visual or observable indicator of insufficient pressure in the expiratory line or catheter. Such an indicator or detection may be provided to medical personnel to note changes in the gas therapy provided to the user. A check may then be performed or adjustments may be made to re-establish the provision of gas therapy to the user. For example, a seal provided by one or both of the nasal interface connection components may have been displaced or the seal may have been broken by the user's nostrils, in which way adjustment of the patient interface may allow resealing and the intended gas therapy may be provided to the user. Alternatively, a gas flow or pressure parameter may need to be changed to re-establish the provision of gas therapy to the user. Alternatively, a device in the patient interface or system may have failed or been blocked and may need to be repaired or replaced.

[0452] The conduit in fluid communication with the expiratory line or conduit, or the first conduit or the second conduit when provided as or part of an expiratory line or conduit, may comprise a detector or indicator as described above.

[0453] A detector or indicator may be provided that is capable of changing color to provide a visual indicator of, for example but not limited to, one or more of the following properties or qualities of the exhaled gas: carbon dioxide, temperature, humidity, pressure.

[0454] In one example, an inflatable balloon or diaphragm can be fluidly coupled to an expiratory line or conduit (or an inspiratory line or conduit, or both expiratory and inspiratory lines or conduits), wherein relative inflation of the balloon or diaphragm provides an indicator or indication that gas therapy is being provided to the user.

[0455] In another example, a pressure sensor (such as a manometer) can be fluidly coupled to an expiratory line or conduit (or, in the alternative, to an inspiratory line or conduit) to provide a signal or indicator of the pressure provided to a user or the user's airway, or the pressure of gas in the expiratory line or conduit (or, in the alternative, the inspiratory line or conduit; or both the expiratory line or conduit and the inspiratory line or conduit).

[0456] The indicator may provide a visual indication or indicator of the pressure in the expiratory line or conduit (or the inspiratory line or conduit or both).

[0457] The above detectors or sensors may generate a signal as one or more of: a visual output, an audible output, an alarm when the sensed pressure is above or below a threshold pressure, an alarm when the sensed flow is above or below a threshold flow value.

[0458] In the case of unidirectional gas flow such as that of the patient interface described herein, such a design can help eliminate bias flow through the interface. For example, the patient interface can reduce or eliminate bias flow or a large amount of bias flow that flows through the interface and out of the interface without entering the nostrils. Thus, the user must attach and receive gas therapy with a positive pressure gas flow present in an expiratory line or catheter. Therefore, a pressure or flow detector disposed in the expiratory portion of the medical breathing circuit can provide a leak detection capability.

[0459] A digital pressure gauge with a display or a similar pressure gauge with a needle can be used to indicate the pressure. The absence of bubbles in the bubble CPAP chamber can also be used as an indicator or detection of loss of therapy.

[0460] Further, depending on the embodiment, the detection mechanism of the loss of therapy may also provide a respiration detection, ie a measurement of the respiration rate. This may be implemented, for example, by a digital (or similar) CO2 meter or a color change material triggered by CO2.

[0461] According to various embodiments, a first sensor including a pressure sensor may be associated with an inspiratory line or duct and a second sensor including a pressure sensor may be associated with an expiratory line or duct. The sensed pressure of each line or duct may be used individually or compared. For example, the pressure difference between the gas in the inspiratory line or duct and the gas in the expiratory line or duct may be determined / measured, and a signal or output of this detection or sensing may be provided (e.g., an alarm or warning or other information provided in a visual, audible, or tactile form).

[0462] Conventional breathing circuits for pressure-dependent therapies such as CPAP typically include a relatively small (in inner diameter) pressure measuring tube that may be fluidly connected to one of the breathing circuit components (e.g., the inspiratory tube, the expiratory tube, the Y-piece or other interface connector, the interface tube, or the interface itself in a dual-limb system). Such a measuring tube will typically have a sufficiently small inner diameter compared to the breathing circuit component to which it is fluidly connected to form a sufficiently high RTF (resistance to flow) to minimize gas flow that escapes through the measuring tube rather than continuing through the breathing circuit component.

[0463] Patient interfaces, systems, and methods as disclosed herein can utilize similar pressure measuring tubes fluidly connected to two nasal prongs (i.e., in a Y-shape), which also have a sufficiently high RTF to minimize gas flow escaping through the measuring tubes. However, the inner diameter can be selected to minimize not only the gas flow into the main branch of the measuring tube (A), but also the gas flow from one nasal interface connection component to the other nasal interface connection component (B), because the gas flow through the tube from one nasal prong to the other nasal prong will reduce the effects caused by the unidirectional flow design described herein. The immediate pressure measurement of the two nasal prongs, which effectively averages the inspiratory and expiratory pressures, is used as a good estimate of the nasopharyngeal pressure in the patient. Conventional pressure measuring tubes fluidly connected to inspiratory or expiratory circuit components may only measure the inspiratory or expiratory pressure, respectively, which is not necessarily a good estimate of the nasopharyngeal pressure. Such a setup, for example, in Figure 7 Shown in.

[0464] exist Figure 7 In the embodiment, the nasal interface connection component identified as item 2 is provided as an inhalation line or catheter, while the nasal interface connection component identified as item 4 is provided as an exhalation line or catheter.

[0465] Advantageously, the ability to measure or determine patient pressure without the need to position or place a sensor within the patient's airway provides a unique development.

[0466] For example, the pressure port may be remote from the patient or located at some distance from the patient, such as at a connector of a breathing circuit, as long as the interface is symmetrical or has a known asymmetry.

[0467] If the interface is symmetrical or substantially symmetrical, then the measured pressure provides a useful approximation of the patient pressure.

[0468] Alternatively, if the interface has a predictable, known or predetermined asymmetry, then the measured pressure plus or minus an offset to account for the asymmetry will produce another useful approximation of the patient's pressure. The specific offset may depend on, for example, the geometry of the interface and may be calculated by one skilled in the art using known methods.

[0469] Furthermore, the same pressure measurement target can be Figure 2The invention can be implemented at or using a valve as shown and discussed with reference thereto. For example, the valve can be significantly, almost or substantially closed so that a very small volume of the majority of the gas flow moves through the valve between the nasal interface connection components, as long as the valve still receives or obtains some pressure input from the two nasal interface connection components. The valve can include a pressure sensor or an output device or port for a pressure sensor, or a port or output device for connecting to a pressure line or catheter to be configured to communicate with the pressure sensor, and then the pressure measurement obtained at the valve or at the pressure port or output device of the valve can be used as a useful approximation of the patient's nasopharyngeal pressure.

[0470] Patient pressure can also be determined in systems or breathing circuits without an expiratory limb or second wall interface connection component (i.e., where the user's second nostril or second side of the interface is open to atmosphere) by averaging the measured pressure at any location in the inspiratory line or conduit or along the inspiratory side of the gas flow with atmospheric pressure (either by using a preset value or by measuring atmospheric pressure each time).

[0471] The discussion provided above regarding pressure measurement calculations or determinations need not occur only in a sealed system or breathing circuit having a patient interface that sealingly engages the nares or airway of a user, as long as the flow rate is high enough.

[0472] The patient interfaces described herein may include a retention system for retaining the interface on the user's face. In this manner, the interface may be deployed and, when worn in an appropriate manner, may provide the intended gas therapy. The retention system may improve the ability to provide the intended gas therapy to the user and may also provide user comfort features or features that may be utilized without fuss by medical personnel (e.g., to allow for convenient application of the interface to the user or readjustment as needed).

[0473] In this manner, in one particular embodiment, the retention system provided for the interface may be an associated two-part releasable connection arrangement such that the interface may be positioned on the user's face and may be removed and repositioned as desired.

[0474] For example, the first part of the two-part releasable connection arrangement can be a skin patch located on the user's face, and the second part of the two-part releasable connection arrangement can be an interface patch located on the user-facing side of the patient interface. The interface patch can be connected to or attached to the user-facing side of the interface, wherein the user-facing side of the interface patch itself includes a part of the two-part releasable connection arrangement, which is releasably connected to or can be attached to the interface-facing side of the skin patch, and the interface-facing side of the skin patch includes another of the two-part releasable connection arrangement and can accommodate the user-facing side of the interface patch. Therefore, the two patches (skin and interface) can be brought together to releasably fasten or connect together, but can be separated from each other to allow adjustment or repositioning as needed (e.g., from a user's comfortable angle or in order to provide gas therapy to the user via the patient interface better or improved or alternative).

[0475] One such suitable two-part releasable connection arrangement is known as the Wigglepad manufactured by Fisher & Paykel Healthcare Limited. TM Arrangement of the fixing system.

[0476] Two such suitable patient interfaces that can be modified to include a sealing system for nasal interface connection components (e.g., nasal prongs of a nasal cannula) can be, for example, the Optiflow Junior TM or Optiflow Junior 2 TM Patient interface for nasal cannula interface.

[0477] Regarding the above-mentioned retaining system involving a two-part releasable connection arrangement or attachment mechanism, such a retaining system may for example be a fixing system as described in PCT / NZ 2011 / 000218 (WO 2012 / 053910) or PCT / NZ 2016 / 050041 (WO 2016 / 148585).

[0478] With respect to the patient interface described above, a patient interface such as that described in PCT / NZ 2011 / 000218 (WO2012 / 053910) (the contents of which are incorporated herein by reference) may be utilized but modified to optionally provide a nasal interface connection component (e.g., a nasal prong) including a sealing capability. In addition, in another embodiment, a nasal cannula such as that described in the document incorporated by reference above may be modified according to the separator described herein for controlling fluid communication between the gas flow paths of the first nasal prong and the second nasal prong. Further, alternatively, with reference to the nasal cannula such as that described in the document incorporated by reference above, a steering valve may be provided to selectively determine or control the conduit and the nasal prong to receive a gas source as an inspiratory flow, and to selectively determine or control the conduit and the nasal prong to receive gas from the user as an expiratory flow.

[0479] In yet further alternative embodiments, the retention system may be a headband. It will be appreciated that various forms of headbands may be provided, depending on the form of the patient interface (e.g., as a nasal cannula type interface or other nasal mask type interface). Where a headband is used, there may be various form factors or other capabilities, including size adjustment, retention, and user comfort features provided.

[0480] In other alternative embodiments, one or more patient interfaces described herein can be used with a two-part retention system that includes an integrated nasogastric (NG) tube or orogastric (OG) tube or other supply tubes that grasp or carry or accommodate one or more structures. For example, a portion or piece of a retention system may include one or more grooves or cutouts for accommodating a supply tube or NG tube or OG tube. In another embodiment, a portion of a retention system may include a flap or a foldable section or extension that can be wrapped around the tube and removably connected back to a portion of the retention system to grasp the supply tube in an operable position and reduce or minimize the chance of displacing the supply tube from use or an operating position. Similarly, the same two-part retention system or the same arrangement or structural type can also be used to fix a medicament tube or a drug tube, such as a surfactant delivery tube or other drug delivery tube, for connection with an output device or port of an inspiratory line or catheter or for administering or delivering a drug to other ports in a gas stream supplied or delivered to a user.

[0481] Examples of two-part releasable connection systems or attachment mechanisms of applicant's PCT / NZ 2017 / 050109 are hereby incorporated by reference FIG. 15A to FIG. 15D A two-part releasable connection system or attachment mechanism may be configured to secure a user interface and / or a user interface tube (or catheter or line) to a patient, such as Fig.15AAn attachment mechanism 1100 is shown that supports a nasal cannula on the face of a patient or user, but may also be adapted to support an adapter for modifying a patient or user interface to accept a drug delivery tube or catheter or line using the same principles (e.g., by including an extension that can be attached to a patch rather than by a clip).

[0482] In some embodiments, the attachment mechanism provides for an overall faster and improved or simplified ease of mounting the user interface to an operating position on a user. Further, these benefits may also help to improve or simplify the ease of application of an alternative user interface or the ease of removal of the user interface from a user as the user cycles between different therapies (such as gas therapy, e.g., CPAP or high flow applications). In various embodiments provided by a two-part releasable connection system or attachment mechanism, such an attachment mechanism or system may provide for quickly positioning the interface to the user, and may provide fixed positioning of the interface.

[0483] In some embodiments, the ease with which the user interface can be positioned is particularly useful to the user.It may be particularly advantageous to provide a system whereby a caregiver (eg, nurse) can apply the securement system with one hand, for example where the interface user is an infant.

[0484] Additionally, in another embodiment, the attachment mechanism provides a first level of fixation of the user interface to the user. For example, such a first level of fixation may be as follows: FIG. 15A to FIG. 15B In situations where the user requires additional or increased security in positioning or securing the user interface, a second level of interface securement may be used. This additional level may include application of a patch, such as by Fig.15D The patch 1260 shown is provided. Such a patch 1260 may be an adhesive patch and may be mounted on the top of the user interface and / or tube and may be adhered to a portion of the skin patch 1150 ( Fig. 15B ).

[0485] The attachment mechanism 1100 comprises a two-part releasable attachment or connection arrangement 1151. The releasable connection arrangement 1151 acts between a pair of patches that are respectively affixed to the patient and the user interface.

[0486] The first patch can be a skin patch 1150 that adheres or is attached to the patient's skin. The skin patch can have a user side facing the user's skin and an interface side facing the user interface. The user side of the skin patch 1150 can be attached to the user's skin by a dermatologically sensitive adhesive (such as a hydrocolloid). The user interface side of the skin patch can be provided with a first part 1153 of a two-part releasable attachment or connection system 1151.

[0487] The second patch can be a user interface patch 1152. The user interface patch 1152 can also have a patient side and an interface side. When engaging the attachment mechanism 1100, the patient side of the user interface patch 1152 can be arranged adjacent to the skin patch. The complementary second part 1153 of the two-part releasable attachment or connection system can be adhered to the patient side of the user interface patch 1152, so that when the patch 1150,1152 is put together, the corresponding part of the two-part releasable attachment or connection system 1151 can be easily engaged. The interface side of the user interface patch 1152 can be adhered to the user interface. The user interface patch can be integrated with the user interface or adhere to the user interface compatibly.

[0488] In some examples, a portion or corner of the user interface patch 1152 may include an area that is not attached to the skin patch 1150. The general purpose of this may be to allow the area (or tab) to be more easily grasped by the user or caregiver to remove or disengage the interface from the skin patch.

[0489] The two-part releasable attachment or connection system arrangement 1151 may include a hook and loop material (such as Velcro TM ), a magnet or array of magnets disposed on the respective patches with the poles suitably arranged, an adhesive arrangement activated when the patches are pushed together, or another suitable releasable suitable connection. The interface side of the skin patch 1150 can have one of the hook or loop materials and the patient side of the user interface patch 1152 can have the other of the hook or loop materials so that the skin and user interface patches are releasably attached or connected to each other.

[0490] When referring to hook and loop materials, the hook and loop materials may refer to any of a variety of zone-type mechanical fasteners. For example, Velcro TM The product range may include hook and loop products where the hook component comprises upstanding nylon hooks (formed as cut loops through a woven backing web) that engage with any complementary loop fleece material. TM The range may also include extruded hook products that are typically smaller in size and are mated to a "fluffy" non-woven fiber backing material. These hook materials are designed to work with a range of loop substrates and in some cases, also function as the loop substrate. Other similar systems include the Dual-Lock from 3M Company, St. Paul, Minnesota, USA TMReclosable fastener system. The common feature of these releasable fastening systems is that they engage at any contact portion between the two parts of the system. No precise alignment of individual connectors is required, because there are many connectors distributed over the entire area of ​​the product. Various releasable fastener systems in the field can be used in releasable attachment mechanisms to provide releasable attachment between the skin patch and the user interface.

[0491] The first part of the releasable attachment or connection system of two-part formula can use suitable adhesive to adhere to the user interface side of skin patch, and occupy up to 100% or lower than about 90% or about 85% or about 75% or about 60% or about 50% or about 40% or about 30% or about 20% or about 10% of the interface side surface area of ​​skin patch.In certain embodiments, skin patch 1150 is the pad of the general plane of thickness far less than width and length.In certain embodiments, described pad has overall oval shape, but can take other shapes.

[0492] The pad may also include a first portion 1153 of a two-part releasable attachment system 1151. In some embodiments, the structure of the skin patch is such that the first portion 553 of the releasable attachment system includes a substrate and a plurality of fastener elements (having effective hooks, effective loops or other elements) provided across an area of ​​the substrate. The substrate is secured to the body of the skin patch. In some embodiments, the substrate is secured by an adhesive or by direct bonding during formation of the skin patch.

[0493] In some embodiments, the substrate can be smaller than the skin patch in area and is located on the skin patch so that it does not reach any edge of the skin patch. In this way, the edge of the substrate extends from the edge of the skin patch that completely surrounds the perimeter of the substrate.

[0494] In some embodiments, the substrate for the first part of the two-part releasable attachment system can be flexible so that the plane of the substrate can be bent to follow a surface that is bent in one direction. However, the substrate is typically not retractable either so as to be able to follow a surface that is bent in two orthogonal directions. However, the pad of the skin patch can be retractable and conformable to a surface that is bent in more than one direction as required by the contour of the placement position on the patient. According to some embodiments, this difficulty is alleviated by providing the first part 1153 of the two-part releasable mechanism in a certain form, wherein the part of the substrate is divided into multiple regions by at least one seam or at least one groove, so that different parts of the substrate part can be bent independently and therefore the overall form of the substrate part can be deformed to substantially match the surface that is bent in two directions. Even if the substrate part is bent only in one direction at any single position on the substrate part, the situation will be so.

[0495] FIG. 15C to FIG. 15D Another embodiment of the attachment mechanism is shown in .Attachment mechanism 1200 may include skin patch 1250 and fixed patch 1260. Fixed patch 1260 may extend over the user interface and / or tube and adhere to skin patch 1250 to fix the interface and / or tube to the patient. Skin patch 1250 may define a fixed footprint attached to the patient and have a similar configuration to the corresponding skin patch 1150 in the above-mentioned attachment mechanism and two-part releasable connection system. The user side of skin patch 1250 is constructed to attach or adhere to the user's skin.

[0496] Fixed patch 1260 can extend on user interface and / or associated user interface tube and stick to skin patch 1250 to fix user interface to patient.Fixed patch 1260 and skin patch 1250 can be constructed so that when fixing system is applied to patient together with suitable or compatible user interface, fixed patch can be contained within or be bounded by the fixed footprint of skin patch.Fixed patch 1260 is contained within the fixed footprint of skin patch 1250 and can reduce the possibility of unnecessary contact with patient's skin and potential stimulation.Ideally, skin patch 1250 can have the same or greater than the surface area of ​​fixed patch 1260.Skin patch 1250 can include a part of two-part mechanical fastener system on its surface or multiple parts on its surface, and wherein fixed patch 1260 has another part of fastening system.

[0497] In this way, the size of the skin patch can be determined to reduce the possibility of tape sticking or any additional tape sticking extending to the user's skin. It is preferred to avoid or minimize the application or repeated application and removal of adhesive on the user's skin. This embodiment beneficially reduces the possibility of adhesive or sticky tape being repeatedly applied to the user's skin to install or place the user interface in the operating position. Sticky tape or other skin adhesive patches (when repeatedly applied and removed) can cause problems, especially when used for infants. Problems include but are not limited to skin irritation (for example, due to skin sensitivity) caused by sticky chemicals (or sticky removal chemicals, such as solvents) or tape materials, due to repeated application and removal of skin patches or tapes to position or reposition the user's interface and the damage caused to the user's skin. In the case of a therapeutic cycle (that is, changing from one treatment type to another, and then repeating back and forth), repositioning may be required or may need to be adjusted. Therefore advantageously, the described embodiment provides a system for placing or positioning a user interface for the user but reducing the possibility of problems associated with the sticky tape attached to the user's skin.

[0498] It should be understood that there are many disadvantages and problems associated with the repositioning of interfaces, particularly infant interfaces. These include "snub noses", epidermal abrasions, or skin irritation from conventional tape-applying techniques used to apply user interfaces (e.g., nasal cannulas) to users. Such problems can also arise in the following process: the user cycles between different treatment options and conventionally subsequently removes the headband or tape or user interface and then installs a new device and user interface or interface positioning headband or other tool. Therefore, providing a fixing system that is in a ready-to-receive mode for receiving a user interface when applied to the user is a useful step in the progress toward reducing the problems that users have previously faced. Further, improving the ease of installation has further benefits in terms of complexity and the time and work of the caregiver (e.g., nurse).

[0499] The shape of the fixing patch can be determined or otherwise configured to accommodate the geometric features or other features of the user interface and / or associated user interface tube. The fixing patch shown can have multiple wings 1261 that accommodate the user interface tube and increase the contact surface of the fixing patch 1260 exposed to the skin patch 1250. Fig.15D The illustrated fixing patches each have a pair of wings disposed at one end of the patch. Wings 1261 are configured to be fixed to the skin patch on either side of the user interface and / or associated user interface tube and reduce the possibility of the fixing patch 1260 rubbing around the interface and / or tube.

[0500] exist Fig.15D The fixing patch 1261 shown in FIG. 1260 may also have a tube end wing 1261. The tube end wing 1261 may be configured to extend under the user interface tube and adhere to the skin patch 1250 to connect the end of the fixing patch 1260.

[0501] The above-described embodiments of attachment mechanisms may all be used to secure the tube to any part of the patient's body. FIG. 15A to FIG. 15D The illustrated embodiment is configured to attach the user interface to the patient's face, particularly adjacent to the user's upper lip and / or cheek.The illustrated securing system may be suitable for neonatal applications.

[0502] The user side of the skin patch 1150, 1250 can have a dermatologically sensitive adhesive (such as a hydrocolloid) that adheres the patch to the user's skin so that application of the corresponding fixing system causes as little irritation as possible. The skin patch 1150, 1250 can have sufficient surface area to distribute the adhesive force and interface retention force over the appropriate area of ​​the user's face to reduce local pressure accumulation.

[0503] In some embodiments, the patient or user's face may also be adapted to support an adapter for modifying the patient or user interface to receive a drug delivery tube or catheter or line.

[0504] Such adapter or the interface comprising such adapter can include a fixing system for keeping, holding or fixing pressure and / or drug delivery conduit (e.g., surfactant delivery lumen) in a suitable position on the patient's face. In certain embodiments, the pressure lumen is configured to be fluidically connected to the pressure tube, and the drug delivery conduit (e.g., surfactant lumen) is configured to be fluidically connected to the drug conduit (e.g., surfactant tube). In certain embodiments, the fixing system includes a two-part releasable attachment or connection arrangement. The releasable connection arrangement works between a pair of parts that are respectively attached to the patient and pressure and / or surfactant tube. PCT / NZ 2013 / 000069 (WO 2013 / 157960) describes several such fixing systems, and the document content is incorporated herein by reference.

[0505] Examples of attachment mechanisms are as follows Figures 16 to 18 Reproduce.

[0506] In the reproduced Figures 16 to 18 In the embodiment of the present invention, the two-part releasable attachment mechanism can further include a structure for maintaining the pressure and / or surfactant tube. In some embodiments, these structures can be a retainer, a clip, a flap, etc.

[0507] For example, Fig.16 As shown, the two-part releasable attachment mechanism may include a panel configured to be folded onto the skin patch to hold the tube. The skin patch 1610 and the panel 1620 are coupled together at the edge region 1613. To couple the first and second parts of the two-part releasable attachment system together, the panel is folded onto the skin patch so that the patient side 1622 of the panel is adjacent to the interface side 1612 of the skin patch to couple the first and second parts 1614, 1624 of the two-part connection system together, thereby capturing or sandwiching the tube 1602 therebetween.

[0508] As another example, Fig.17Shown is a two-part releasable attachment mechanism further comprising a clip for fixing pressure and / or surfactant tubes. The skin patch 1710 for adhering to the patient's skin can include a fixing clip 1720, which is attached to the skin patch or is formed integrally with the skin patch. The fixing clip includes a recessed portion or a cavity or a channel for receiving tube 1702. The recessed portion is open so that a certain section of the tube can be pushed into the clip in a transverse direction relative to the longitudinal axis of the tube. One end of the tube does not need to be pushed through the clip to fix. The recessed portion can have a transverse dimension similar to or slightly smaller than the diameter of the tube so that the tube can be firmly clamped by the clip. In one embodiment, the clip can be released from the skin patch. For example, the aforementioned two-part connection system can be applied between the clip and the skin patch. Alternatively, the clip can be releasably attached to the patient interface 1700.

[0509] Fig.18 A two-part releasable attachment mechanism is shown with a wing portion configured to wrap around and secure a pressure and / or surfactant tube. The securing system 1805 may include a skin patch 910 for attachment to the patient's face. The skin patch includes a wing portion 932 for wrapping around the tube 2 once the tube has been properly positioned in the patient's nostril.

[0510] FIG. 19A to FIG. 19B Embodiments of securing structures configured to secure pressure and / or drug delivery tubes or catheters or lines, such as surfactant tubes, are shown. Fig.19A and Fig.19B A fixing structure assembly is shown having a perforated section which allows the fixing structure to be removed from the tube to be fixed.

[0511] A close up view of a patient's face with a nose N and a mouth M is shown. The fixed structure assembly 1900 can be torn along the tear line T, thereby removing one of the detachable extensions 1904B. In the illustrated embodiment, a pair of perforated sections connect the body 1902 to one of the detachable extensions 1904A, 1904B. The body 1902 and the detachable extension 1904A still attached to the body 1902 can be placed on one side of the face, and the detached detachable extension 1904B can be adhered to the other side of the face using the adhesive portion 1908B, thereby exposing the fixing element 1910B of the detached detachable extension 1904B. The tube 1940 can be placed on the body 1902, and the detachable extension 1904A attached to the body 1902 can be folded to cover the tube 1940.

[0512] like FIG. 19A to FIG. 19BAs shown, the tube 1940 can be positioned in or adjacent to the perforated area (e.g., the first intermediate area 1905A). This can facilitate the quick and simple removal of the fixed structure assembly 1900 from the tube 1940. Therefore, when removing the fixed structure, the tube 1940 does not necessarily have to be removed, and the care provider is not required to reinsert the tube 1940 after removing the fixed structure assembly 1900, thereby reducing the number of steps required. Positioning the tube 1940 in or adjacent to the perforated area can help enable the fixed structure assembly 1900 to be folded and / or glued to itself. For example, this can help fold the detachable extension 1904A onto the body 1902.

[0513] In some instances, the molded portion line may also be down along the central plane of symmetry of the adapter (rather than splitting along the threaded connector). In some instances, the threaded connectors may also be arranged so that their axes are parallel to the plane of symmetry but offset from the center so as to form a space between them. In some instances, this may allow for a more compact arrangement and simpler tooling, and reduce motion complexity. This may also include a pressure port oriented longitudinally between them.

[0514] The illustrated fixation system is particularly configured to receive and / or fix a patient interface or adapter and any necessary tubes, such as a drug delivery tube or a nasogastric tube. The tubes may extend from one or both sides of the user's face. In some embodiments, the patient interface and fixation system may include a dynamic interface for absorbing the patient's facial movements. The dynamic interface may be used to suppress the effects of an infant's facial movements on the positioning of the patient interface around the patient's nose. PCT / NZ2014 / 000217 (WO2015 / 057083) discloses an example of a dynamic interface, the contents of which are incorporated herein by reference.

[0515] Examples of attachment mechanisms of PCT / NZ 2014 / 000217 (WO 2015 / 057083) are hereby incorporated by reference. FIG. 20A to FIG. 20C , FIG. 21A to FIG. 21C and Fig. 22 Reproduction. In some embodiments, the dynamic interface can include one or more hinges along the device that responds to natural and forced facial movement and external forces applied to the interface. The hinge can minimize the effects of facial movement and external forces on fitting the interface to the patient's face, specifically placing the nasal prongs in the patient's nostrils. As used herein, a hinge generally refers to a portion of an interface that is configured to bend in one or more directions. The hinge can be configured to bend in one or more predetermined directions, and in some embodiments the hinge can be constrained to not bend in certain directions.

[0516] FIG. 20A to FIG. 20B shows an example of an infant's relaxed facial shape, and Fig. 20C A schematic diagram of the geometry of the dynamic interface 1300 positioned on a relaxed face is shown. Fig. 20A is a front view of the baby's face and Fig. 20B This is a bottom view of the baby's face. Fig. 20C 13 is a bottom view of a dynamic interface. The dynamic interface 1300 may have one or more hinges 1310. Preferably, the dynamic interface has a central hinge 1312 disposed between nasal prongs 1330. Multiple hinges 1310 on the interface allow the interface 1300 to conform to the general contours of the patient's face.

[0517] FIG. 21A to FIG. 21B Examples of stressed or squeezed facial shapes of infants are shown in front and bottom views, respectively. Fig. 21C A schematic bottom view of the geometry of the dynamic interface 1400 positioned on a squeezed face is shown. A squeezed face approximates the distortion of the face when, for example, a patient lies on his side. Fig. 21C As shown, hinge 1410 helps to conform the interface 1400 to the shape of a distorted face and maintain the position of the nasal prong 1430 in the patient's nostril. The dynamic interface 1400 is particularly useful in situations where infants or other patients tend to exhibit exaggerated cheek movements. Nasal prong flicking can be reduced.

[0518] Each hinge 1410 can be constructed to react to the applied force in a predetermined manner, and different hinges can react differently depending on their position on the interface. For example, the hinge 1412 located in the area between the nasal prongs 1430 can be bent downward toward the lips and / or bend inward toward the face to form a concave shape (when viewed from the front), while the hinge 1414 adjacent to the patient's cheek can be bent outward to form a convex shape around the cheek. The hinge 1412 can resist movement perpendicular to the face outward and minimize the movement of the nasal prongs 1430 away from the nostrils due to the force applied laterally to the device. In some cases, the bending of the hinge 1412 can be limited by the patient's anatomical structure. For example, the inward bending of the hinge 1412 can be limited by the patient's philtrum, which can beneficially limit the displacement of the nasal prongs 1430. Once the hinge 1412 reaches its limit, the force applied to the interface can act on other hinges (e.g., hinges 1414 adjacent to the cheeks). The combination of hinge type and hinge location can allow the designer to control how the interface will react in various situations. The hinge can be designed to allow 1, 2, or 3 degrees of motion in any predefined direction depending on the desired functionality. Advantageously, an inherently stable interface can be developed that is able to maintain the nasal prongs in the patient's nares under different loading conditions.

[0519] Fig. 22Another example of a dynamic nasal interface 1500 is shown. Although the interface shown is a nasal cannula, the articulated portion can be adapted to support the adapter disclosed herein using the same principles (e.g., by including an articulated extension that attaches to the patch discussed above).

[0520] For example, Fig. 22 A nasal interface 1500 is shown with hinges in at least three locations, the hinges being a bridging hinge 1510 and external hinges 1512, 1514 on either side of the nasal prongs. The additional hinges of the nasal interface help stabilize the position of the nasal prongs 1502 when the cannula is stressed and reduces the displacement distance, thereby helping to keep the nasal prongs in the patient's nostrils and reducing irritation of the nasal prongs to the nostrils. In some embodiments, the bridging hinge 1510 and the external hinges 1512, 1514 can be constructed to be attachable to the above-mentioned patch to support the disclosed adapter.

[0521] PCT / NZ 2014 / 000217 (WO 2015 / 057083) further presents additional embodiments of dynamic interfaces, the contents of which are incorporated herein by reference.

[0522] With respect to the various patient interfaces described herein, where, for example, the patient interface may be a nasal cannula type interface, the nasal cannula may have an arrangement as described in PCT / NZ 2011 / 000218 (WO2012 / 053910) or PCT / NZ 2014 / 000217 (WO2015 / 057083), the contents of each of which are incorporated herein by reference. In particular, the nasal cannula described in these documents provides a nasal cannula system comprising separate or independent gas flow paths, wherein at least one element is additionally provided that is responsive to a force or motion or both experienced by at least a first region of the patient interface.

[0523] In this way, compensation can be provided by the patient interface for the movement of the user transitioning to the interface, which may otherwise include providing the intended gas therapy or relocating, for example, a nasal interface connection component (e.g., a nasal prong) away from the user's nostrils. In particular for pressure-controlled gas therapy, such compensation can help minimize the likelihood of a loss of a sealed connection between the nasal interface connection component and the user's nostrils, which would result in a loss of gas therapy provided to the patient. Therefore, a patient interface as described herein can be modified according to the functional and mechanical modes listed in the documents cited above. Specifically, the functions and mechanisms of the nasal cannula interface referenced in the above documents can be provided to the nasal cannula in an area outside of the bridging area of ​​such nasal cannula.

[0524] According to the documents cited above, the patient interfaces described herein can be modified according to the referenced documents, but additionally provide sealing capabilities of the nasal interface connection components (e.g., the nasal prongs of the nasal cannula). In such embodiments, the associated conduits of each nasal interface connection component (e.g., the conduits or tubes associated with each) can have reinforcement types described in those referenced documents.

[0525] With respect to the various patient interfaces described herein, such patient interfaces may be modified or include those features described in PCT / NZ 2013 / 000069 (WO 2013 / 157960) and PCT / NZ 2016 / 050050 (WO2016 / 159783), the contents of which are each incorporated herein by reference. Specifically, the contents of these documents provide various supply tube retention systems or capabilities that may be integrated into the patient interfaces described herein or as part of such systems described herein.

[0526] This retention system is not only applicable to supply tubes, but also to other tubes or catheters or devices that need to be fixed in place. For example, a catheter or supply line or an output device or port for supplying or delivering drugs to an inspiratory catheter or a catheter for supplying or delivering drugs on the inspiratory side of a patient interface can be held in place using the retention system described in the above patent specification. For example, a drug delivery catheter can be fluidly connected to Fig.12 and Fig.13 An output device or port 410 is shown. Such a drug may be, for example, a surfactant which may be aerosolized for addition to the gas stream.

[0527] In a further alternative, a patient interface having an output device or port for connection to a drug delivery catheter or line or conduit may be utilized. Some form of adapter may be provided or configured to connect to the output device or port to enable a drug delivery catheter or supply line or conduit connection to the interface. It will be appreciated that the output device or port may be in or on the patient interface itself, such as a nasal cannula or Y-piece, or as part of a conduit disposed on the inspiratory side of a breathing circuit, for introducing a drug, which may be an aerosolized drug, such as a surfactant or an aerosolized surfactant, into the gas stream delivered to the user.

[0528] A particular advantage of delivering medication through a one-way interface is the ability to direct all or substantially all of the medication doses given into the gas stream to the user. This is achieved by providing a way to direct the entire inspiratory flow into the user / patient. This provides significant advantages and helps solve the main problem of medication delivery, where a large amount and sometimes all of the medication delivery is flushed out of the interface by the bias flow or patient expiratory flow that impacts the medication delivery and is not delivered to the user / patient. If, for example, the gas delivery flow rate supplied to the user / patient is about 8L / min and the user / patient peak inspiratory requirement is only about 500mL / min, the user / patient's ability to take medication is limited and many of the medication doses attempted to be delivered may instead end up passing through the expiratory duct or bypass. This may occur even if a clinician or medical assistant attempts to determine the timing or dosage of medication delivery to match the timing of the inspiratory phase of the user / patient's breathing cycle.

[0529] Thus, the ability to provide drug delivery to the inspiratory side of the breathing circuit (e.g., the inspiratory catheter) or the inspiratory side of the patient interface (e.g., the upstream side of the first nasal interface connection component) provides a simpler and more efficient mode of delivering the drug to the user / patient. Such administration allows for a more effective drug delivery system without the complexity of attempting to match drug delivery to the inspiratory phase of the user / patient.

[0530] A patient interface as described herein may be configured to receive one or more medicaments or to provide delivery of one or more medicaments to the nostrils of a user of the interface. For example, a medicament may be delivered to an inspiratory line or catheter or to a nasal interface connection component (when provided as part of an inspiratory line or catheter). The medicament may be atomized or sprayed for delivery into a gas stream in an inspiratory line or catheter or into a gas flow path of a nasal interface connection component (when operable as part of an inspiratory line or catheter). In this way, a dedicated or unique inspiratory nasal interface connection component may be provided for direct delivery to a user.

[0531] With respect to drug delivery, an adjustable or controllable partition between the nasal interface connection components can be configured to prevent any fluid communication between the gas flow paths of the two interface connection components during drug delivery, and thereby prevent inadvertent loss of drug that is not delivered to the user. However, in such an arrangement, the partition of the interface can be configured after delivery back to a specific setting. For example, a specific setting for a patient can provide a desired bias flow between the nasal interface connection components to fine-tune the gas therapy provided to that patient.

[0532] Drug delivery can be used in combination with various gas therapies.

[0533] The following is an overview of various gas therapies that may be used in conjunction with the patient interfaces, systems, and methods described herein:

[0534] Bubble CPAP

[0535] A nasal interface connection component provided on the expiratory line or conduit can be provided in fluid communication with an associated conduit (e.g., an expiratory conduit) leading to a bubbler (which adjusts PEEP by forcing gas through water), as in a conventional bubble CPAP device. The flow of exhaled gas forces the water down through a "dipstick" (an adjustable tube or pipette within the bubbler), and the gas then escapes to the atmosphere as bubbles in the water contained in the bubbler chamber. The deeper the dipstick is below the water level, the greater the pressure required for the gas to force the water through the dipstick.

[0536] • During operation, if the chamber is bubbling, it indicates that the exhaled gas pressure must be at least X cm H2O, where X is the depth of the dipstick below the water level in cm. The absence of bubbles may indicate a treatment failure.

[0537] The bubble chamber also acts as a pressure limiter because once the chamber is bubbled, the pressure is relieved, so it is difficult for the pressure to rise above the setting on the scale. Therefore, this setting determines the PEEP in the patient.

[0538] Manual ventilation / resuscitation

[0539] The nasal interface connection provided on the exhalation line or conduit can be placed in fluid communication with an associated conduit (e.g., an exhalation conduit) leading to a PEEP (positive end expiratory pressure) valve. The pressure (above atmospheric pressure) remaining in the lungs at the end of exhalation

[0540] Ventilator CPAP / BiPAP / (S)NiPPV

[0541] • A nasal interface connection component provided on an expiratory line or conduit may be provided in fluid communication with an associated conduit (eg, an expiratory conduit) returning to the ventilator.

[0542] CPAP is continuous positive airway pressure, which is designed to deliver air at a relatively constant pressure to "clamp" the user's upper airway.

[0543] BiPAP is bilevel positive airway pressure (similar to CPAP, but with different pressure levels for inspiration and expiration).

[0544] (S)NiPPV - (Synchronized) Nasal Intermittent Positive Pressure Ventilation, which is generally similar to CPAP, but with PIP intervals and is essentially synchronized with the respiratory rate to provide the patient with a "breath"

[0545] SiPAP (Synchronized Intermittent Positive Airway Pressure, Flow-Driven CPAP)

[0546] - A nasal interface connection component provided on an expiratory line or catheter may be provided in fluid communication with an associated vent, such as a vent that opens directly to atmosphere (eg, through a filter).

[0547] According to the description herein, a system may be provided, the system comprising a gas source, a conduit provided as a suction line or catheter, and the above-mentioned patient interface.

[0548] The gas source may be a pressurized gas delivery source, such as via a blower or ventilator.

[0549] The system may be a medical breathing circuit, wherein the circuit is a closed system or circuit, or the circuit is an open system or circuit.

[0550] A system as described herein may provide a CPAP delivery system.

[0551] In another example, a system is provided that includes a component fluidly connected or in fluid communication with an expiratory line or conduit or an associated conduit of an expiratory line or conduit.

[0552] The expiratory line or conduit may be fluidly coupled to a downstream component or device configured to provide a predetermined or adjustable back pressure or PEEP substantially at the opening of the nasal interface connection component provided as an expiratory line or conduit for a user.

[0553] Since each nasal interface connection component includes a fluid pathway, the fluid pathway passes through or can be connected through the associated conduit at one end when selectively utilizing the associated conduit (for example, by adjusting the above-mentioned diverter valve), and independent or dedicated fluid connections can be made through the openings of the nasal interface connection components to which the associated conduits are connected (for example, a first associated conduit is set to be in fluid communication with a first nasal interface component).

[0554] According to the above embodiment, in a further alternative, a patient interface may be provided, the patient interface comprising: a pair of nasal interface connection components, one of the pair of nasal interface connection components being configured to deliver inspiratory gas only to one nostril of the user, and the other of the pair of nasal interface connection components being configured to receive expiratory gas only from the other nostril of the user; and a valve operable to selectively control which of the pair of nasal interface connection components provides inspiratory gas to the user, and which of the pair of nasal interface connection components receives expiratory gas from the user. Such a patient interface may optionally include one or more of the above embodiments or features.

[0555] In addition, according to the above-mentioned patient interface: in a first mode, the valve may be operable to allow inspiratory gas to be delivered to a first nasal interface connection part in a pair of nasal interface connection parts and to allow a second nasal interface connection part in the pair of nasal interface connection parts to receive exhaled gas from the user; in a second mode, the valve may be operable to allow inspiratory gas to be delivered to a second nasal interface connection part in a pair of nasal interface connection parts and to allow the first nasal interface connection part in the pair of nasal interface connection parts to receive exhaled gas from the user.

[0556] According to the above embodiment, in a further alternative, a patient interface can be provided, which includes a pair of nasal interface connection components configured to be in fluid communication with the user's nostrils; a bridging portion that (optionally mechanically) connects the nasal interface connection components; wherein the bridging portion includes a bridging valve constructed to fluidly connect each of the pair of nasal interface connection components.

[0557] Relative to the above-described embodiments, each nasal interface connection component includes a gas passageway at one end of which is an opening for fluidly communicating with a user's nostril, and at the other end of the gas passageway is an associated conduit for extending the gas passageway.

[0558] Optionally, the bridge valve is operable to adjust or control a bias flow of gas delivered to the user via the nasal interface connection component.

[0559] Optionally, the valve is operable to selectively control which one of the nasal interface connection parts provides inhalation gas to the user and which one of the nasal interface connection parts receives exhalation gas from the user. For example, in a first mode, the valve allows inhalation gas to be delivered to the first nasal interface connection part of a pair of nasal interface connection parts and allows the second nasal interface connection part of the nasal interface connection parts to receive exhalation gas from the user; in a second mode, the valve allows inhalation gas to be delivered to the second nasal interface connection part of a pair of nasal interface connection parts and allows the first nasal interface connection part of the nasal interface connection part to receive exhalation gas from the user.

[0560] According to the various nasal patient interfaces described herein, one of the pair of nasal interface connection components can be constructed to deliver inspiratory gas only to one nostril of the user, and the other nasal interface connection component in the pair can be constructed to receive expiratory gas only from the other nostril of the user.

[0561] According to the above embodiment, in a further scheme, a patient interface can be provided, the patient interface comprising: a first nasal interface component, the first nasal interface component is used to provide a fluid connection with a first nostril of a user; an inspiratory gas passageway, the inspiratory gas passageway is in fluid communication between the first nasal interface component and a gas source to provide inspiratory gas to the first nostril of the user; a second nasal interface component, the second nasal interface component is used to provide a fluid connection with a second nostril of the user; and an expiratory gas passageway, the expiratory gas passageway is used to receive expiratory gas from the second nostril of the user. In such a configuration, the fluid communication between the inspiratory gas passageway and the second nasal component is disconnected.

[0562] According to the above embodiment, in a further alternative, a patient interface may be provided, comprising: a first nasal interface component, the first nasal interface component being used to provide a substantially sealed fluid connection with a first nostril of a user; an inspiratory gas pathway, the inspiratory gas pathway being in fluid communication between the first nasal interface component and a gas source to provide inspiratory gas to the first nostril of the user; a second nasal interface component, the second nasal interface component being used to provide a substantially sealed fluid connection with a second nostril of the user; and an expiratory gas pathway, the expiratory gas pathway being used to receive expiratory gas from the second nostril of the user, wherein the inspiratory gas pathway is not in fluid communication with the second nasal component.

[0563] According to the above embodiment, in a further alternative, a method of delivering a gas flow to a user through the patient interface described herein may be provided, such that a dedicated inlet nasal interface connection component is provided for providing a dedicated inspiratory flow to one nostril of the user, and an exhaled flow or expiratory flow is conveyed away from the other nostril of the user via a dedicated outlet nasal interface connection component.

[0564] According to the above embodiment, in a further alternative, a method can be provided for delivering a unidirectional gas flow through a dedicated inlet nasal interface connection component and transmitting the exhaled flow away via a dedicated outlet nasal interface connection structure so that the gas flow is turned or redirected within the user's nasal passage.

[0565] According to the above method, two nasal interface connection components are constructed to seal with the user's nostrils.

[0566] Optionally, the unidirectional gas flow can be selectively directed to the first nasal interface connection component or the second interface connection component, the selected nasal interface connection component becoming the dedicated inlet nasal interface connection component, and the other nasal interface connection component becoming the dedicated outlet nasal interface connection component.

[0567] Optionally, the flow redirector is operable to selectively redirect the flow of gas to either the first nasal interface connection component or the second interface connection component.

[0568] Optionally, a partition or fluid path controller is operable to facilitate fluid connection between each of the first nasal interface connection component and the second interface connection component. The partition or fluid path controller may be operable to control or adjust the bias flow of the gas flow delivered to the nasal interface connection component.

[0569] According to the above embodiment, in a further alternative, a method of administering gas therapy to a user may be provided, the method comprising: delivering a first gas flow to a first nasal interface connection component as an inspiratory flow, the first nasal interface connection component being configured to be in fluid communication with a first nostril of the user; receiving a second gas flow from a second nasal interface connection component as an expiratory flow, the second nasal interface connection component being configured to be in fluid communication with a second nostril of the user; and controlling the expiratory flow.

[0570] Optionally, the exhaled flow is controlled according to any one or more of the following gas parameters: pressure, flow rate.

[0571] Optionally, the exhaled flow is controlled to provide an upstream parameter according to any one or more of the following: pressure, flow rate.

[0572] Optionally, the parameter to be controlled affects the pressure of gas provided to or experienced by the airway of the user.

[0573] Optionally, the gas therapy delivered to the user is CPAP gas therapy.

[0574] Optionally, expiratory flow (or optionally inspiratory flow) is controlled by or directed to one or more of:

[0575] a bubbler or bubble CPAP device or another pressure regulator for regulating the pressure provided to or experienced by the user's airway;

[0576] A ventilation or resuscitation device, such as for providing any one or more of the following gas therapy to the user, including but not limited to continuous positive airway pressure (CPAP), BiPAP, NiPPV;

[0577] A flow generating device or flow driver, such as for providing desired gas therapy to the user, including but not limited to SiPAP.

[0578] The various embodiments described above may provide for a patient interface, system, or method that provides one or more of the following advantages:

[0579] Eliminate mechanical dead space in the patient interface

[0580] "Flush" (reduce) anatomical dead space in the user's airway

[0581] Flushes more CO2 out of the patient's airway, reducing the amount of CO2 that is re-breathed

[0582] More accurate / predictable pressure delivery

[0583] • All the pressure generated by the gas source is delivered to the user, without having to account for uncertain pressure losses from bias flow through the interface.

[0584] The Y-shaped tube can improve the accuracy of estimating nasopharyngeal pressure compared to conventional tubes that measure only one side.

[0585] May reduce spontaneous breathing rate

[0586] When used with oxygen therapy, may reduce the percentage of oxygen delivered

[0587] More efficient delivery of aerosolized drugs

[0588] May reduce the user's work of breathing

[0589] With respect to a possible reduction in the user / patient's work of breathing, while one might think that the work of breathing might increase because the user / patient has to exhale from a single nostril, Applicants surprisingly found that unless high bias flow is present, the user / patient's work of breathing is not higher, but rather lower.

[0590] The bias flow rate can be, for example, up to or greater than about 14 L / min, or up to about 15 L / min, or up to about 16 L / min, or up to about 17 L / min, or up to about 18 L / min, or up to about 19 L / min, or up to about 20 L / min, or up to about 21 L / min, or up to about 22 L / min, or up to about 23 L / min, or up to about 24 L / min, or up to about 25 L / min, or up to about 26 L / min, or up to about 27 L / min, or up to about 28 L / min. Up to about 27 L / min, or up to about 28 L / min, or up to about 29 L / min, or up to about 30 L / min, or up to about 31 L / min, or up to about 32 L / min, or up to about 33 L / min, or up to about 34 L / min, or up to about 35 L / min, or up to about 36 L / min, or up to about 37 L / min, or up to about 38 L / min, or up to about 39 L / min, or up to about 40 L / min, or Up to about 41 L / min, or up to about 42 L / min, or up to about 43 L / min, or up to about 44 L / min, or up to about 45 L / min, or up to about 46 L / min, or up to about 47 L / min, or up to about 48 L / min, or up to about 49 L / min, or up to about 50 L / min, or from about 14 L / min to about 50 L / min, or from about 14 L / min to about 45 L / min, or from about 14 L / min to about 50 L / min, or from about 14 L / min to about 45 L / min, or from about 14 L / min to about 40 L / min, or about 14 L / min to about 35 L / min, or about 14 L / min to about 30 L / min, or about 14 L / min to about 25 L / min, or about 14 L / min to about 20 L / min, or less than about 50 L / min, or less than about 45 L / min, or less than about 40 L / min, or less than about 35 L / min, or less than about 30 L / min, or less than about 25 L / min, or less than about 20 L / min.

[0591] The above description of the invention includes preferred forms of the invention. Modifications may be made to the invention without departing from the scope of the invention.

Claims

1. A patient interface, comprising: a pair of nasal interface connection components configured to deliver inspiratory gas to a user and configured to receive expiratory gas from the user, the pair of nasal interface connection components comprising a first nasal interface connection component and a second nasal interface connection component; a bridging region located between the pair of nasal interface connection components; and a bridge valve operable to selectively control the passage of gas through the pair of nasal interface connection components, wherein the bridge valve is disposed in the bridge region; Wherein, in one mode, the bridge valve is operable to provide inhalation gas to the user through only one of the first nasal interface connection component and the second nasal interface connection component and to receive exhalation gas from the user through only the other of the first nasal interface connection component and the second nasal interface connection component; wherein, in another mode, the bridge valve is operable to allow inspiratory gas to be delivered to both a first nasal interface connection part and a second nasal interface connection part of the pair of nasal interface connection parts; and Wherein one or both of the first nasal interface connection component and the second nasal interface connection component are configured to substantially sealingly engage or interface with a user's nostrils.

2. The patient interface of claim 1, further comprising a divider between the first nasal interface connection component and the second nasal interface connection component.

3. A patient interface according to claim 2, wherein the partition provides a mechanical fluid disconnect between the fluid flow path of the first nasal interface connection component and the fluid flow path of the second nasal interface connection component.

4. A patient interface according to claim 2, wherein the divider provides an adjustable or controllable mechanical fluid connection and / or disconnection between the fluid flow path of the first nasal interface connection component and the fluid flow path of the second nasal interface connection component.

5. A patient interface according to claim 2, wherein the partition comprises the bridge valve.

6. A patient interface according to claim 1, wherein the bridge valve is operable to adjustably control fluid communication between the gas pathways of each of the pair of nasal interface connection components.

7. A patient interface according to claim 1, wherein the bridge valve provides fluid communication between the pair of nasal interface connection components.

8. A patient interface according to claim 1, wherein the bridging valve is operable to switch the patient interface to another mode, namely a CPAP mode, in which the bridging valve opens to allow inspiratory gas to flow to reach both the first nasal interface connection part and the second nasal interface connection part of the pair of nasal interface connection parts.

9. The patient interface of claim 1, further comprising a diverter valve that connects a gas source fluid to one of: a first conduit and a first nasal interface connection component, and a second conduit and a second nasal interface connection component to provide an inspiratory line.

10. A patient interface according to claim 9, wherein: The diverter valve fluidly connects gas received from one of the first nasal interface connection component and the second nasal interface connection component via an associated conduit to provide an exhalation line.

11. A patient interface according to claim 10, wherein an associated conduit for the inspiratory line is connectable to a gas source and a separate associated conduit for the expiratory line is connectable to a downstream component.

12. A patient interface according to claim 9, wherein the diverter valve is operable to allow alternating delivery from the gas source to one of a first nostril of a user and a second nostril of a user.

13. A patient interface according to claim 10, further comprising a pressure detector or a gas flow detector in the exhalation line, wherein the pressure detector or gas flow detector serves as an indicator of leakage or loss of gas therapy provided to the user.

14. A patient interface according to claim 10, wherein the exhalation line is capable of being fluidly connected to a downstream component, which is configured to provide a predetermined or adjustable back pressure or PEEP substantially at the opening of one of the pair of nasal interface connection components.

15. The patient interface of claim 10, wherein a pressure sensor is coupled to an exhalation line to provide a signal indicator of the pressure provided to the user or the pressure of gas in the exhalation line.

16. A patient interface according to claim 10, wherein a pressure difference between gas in the inspiratory line and gas in the expiratory line, or a measurement of the average pressure across the nares of a user is determined or measured.

17. A patient interface according to claim 1, wherein the patient interface includes a retention system for retaining the patient interface on the face of a user, the retention system including an associated two-piece releasable connection arrangement so that the patient interface can be positioned on the face of the user and removed and repositioned as needed.

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