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A Respiratory Therapy System, Incubator, And Medical Breathing Gas Delivery Conduit Therefor

Abstract: In accordance with this disclosure, we provide a medical conduit configured to deliver breathable gases in a respiratory therapy system. The medical conduit comprises: i. a first conduit end connector configured to be connected to a user interface; ii. a second conduit end connector configured to be connected to a heated inspiratory conduit; iii. the medical conduit further comprising at least one portion intermediate the first and second conduit end connectors made from a breathable material; iv. the medical conduit being configured to connect the user interface to the heated inspiratory conduit; v. the medical conduit being configured, when connected to the user interface and the heated inspiratory conduit, to be located in an incubator; wherein vi. the medical conduit is unheated. Such a medical conduit can be used in a respiratory therapy system, which comprises an incubator, with the medical conduit inside the incubator.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
22 June 2022
Publication Number
44/2022
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
sna@sna-ip.com
Parent Application

Applicants

FISHER & PAYKEL HEALTHCARE LIMITED
15 Maurice Paykel Place East Tamaki Auckland, 2013

Inventors

1. BABBAGE, Sean Joel
15 Maurice Paykel Place East Tamaki Auckland, 2013
2. SANSON, Samuel Carey Mathew
15 Maurice Paykel Place East Tamaki Auckland, 2013

Specification

A RESPIRATORY THERAPY SYSTEM, INCUBATOR, AND MEDICAL BREATHING GAS DELIVERY CONDUIT THEREFOR

INCORPORATION BY REFERENCE

[001] This application is related to international PCT applications having publication numbers W02006/019323 filed 19 August 2005, W02014/077706 filed 14 November 2013, WO2016/048172 filed 24 September 2015, WO2013/022356 filed 10 August 2012, W02017037660 filed 2 September 2016, WO2011/077250 filed 22 December 2010, and W02013/073970 filed 21 September 2012, each of which is incorporated herein by reference in its entirety.

FIELD OF THE DISCLOSURE

[002] The present disclosure generally relates to respiratory therapy systems for providing breathable gases to users, and more particularly to medical breathing gas delivery conduits in breathing circuits used with respiratory therapy systems that include humidifiers.

BACKGROUND

[003] Many respiratory therapy systems deliver breathable gases, and sometimes also heated and/or humidified, breathable gases for various medical procedures, including respiratory treatment, laparoscopy, and the like. These systems can be configured to control temperature, humidity and flow rates using feedback from one or more sensors. To maintain desirable properties of the breathable gases upon delivery to a user, a breathing circuit of the respiratory therapy system can have one or more heaters associated with components in the breathing circuit, such as gases conduits, where the one or more heaters provide heat to the breathable gases as it flows to the user. The conduit heater(s) can be controlled to provide heat to the breathable gases so that the breathable gases arrives to the user having desirable properties such as temperature and/or humidity. Such a respiratory therapy system can include a temperature sensor to provide feedback to a controller which can adjust and/or modify power delivered to the conduit heater(s) to achieve a target temperature at a location along an associated gases conduit.

[004] An inspiratory circuit of a respiratory therapy system can be provided which comprises a heated conduit with a temperature sensor located at the user end of said conduit to measure the temperature of the gases flow being provided to the user. An example of such a circuit is described in our earlier PCT application W02006/019323 (herein WO’323).

[005] The main purpose of heating the inspiratory flow of gases occurs when the respiratory therapy system includes a humidifier (for example, as a standalone humidifier or as part of an integrated humidifier- flow generator). The humidifier heats and humidifies the respiratory gases to a target dewpoint, which are then delivered to the user via the inspiratory conduit. The inspiratory conduit is the term typically used to describe the gases conduit of the inspiratory circuit that is connected between the humidifier outlet and the user interface that is typically worn by the user. Without heating the inspiratory conduit, the temperature of these gases can then drop as they pass to the user interface. If the temperature of the gases drops below the dewpoint at any point in the inspiratory circuit, then condensation or “rainout” can occur.

[006] The heated conduit described in WO’ 323 prevents condensation by heating the gases passing through the conduit. The power supplied to the conduit is regulated by one or more controllers of the system using a temperature signal provided by the temperature sensor located at the user end of the inspiratory conduit. The controller sets a target temperature for the user end of the inspiratory conduit, and then adjusts the power supplied to the conduit based on the difference between said target temperature and the measured value. The target temperature is generally set at or above the measured, estimated, or target dewpoint temperature of the gases exiting the humidifier. The heat produced by the heater (for example one or more heater wires) of the heated conduit is relatively consistent across the length of the conduit, and provided the rate of heat loss is also relatively consistent across the length of the conduit, then the temperature should be maintained above the dewpoint throughout the conduit.

SUMMARY

[007] The systems, methods and devices described herein have innovative aspects, no single one of which is indispensable or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be summarized.

[008] Throughout, the term ‘respiratory therapy system’ can be interchanged with ‘breathing assistance apparatus’.

[009] Throughout, the term “circuit” in this specification means the entire breathable gases inspiratory pathway to the user from a gases supply, and may also include the expiratory gases path away from the user to a gases supply. The circuit at a minimum should therefore include the inspiratory gases pathway (including all the components) from the gases supply to the user interface. The interface itself e.g. mask or cannula, is separate from the gases pathway and not part of the ‘circuit’.

[0010] Throughout, ‘gases conduit’ is any conduit configured to transport breathable gases or respiratory gases.

[0011] Some embodiments provide for an inspiratory limb for a breathing circuit. The inspiratory limb described herein is particularly useful in situations where heated and humidified gases must pass through two distinct environments. This can be a problem, for example, in infant incubators where the temperature may be significantly higher than the surrounding environment or where a portion of the conduit delivering the gases to the user is under a blanket. The embodiments disclosed herein, however, can be used in any environment where heated and/or humidified gas is delivered to a user where the inspiratory limb passes through two distinct environments having one or more different conditions.

[0012] According to an aspect of this disclosure there is provided a medical conduit configured to deliver breathable gases in a respiratory therapy system; the medical conduit comprising:

a first conduit end connector configured to be connected to a user interface;

a second conduit end connector configured to be connected to a heated inspiratory conduit;

the medical conduit further comprising at least one portion intermediate the first and second conduit end connectors made from a breathable material;

the medical conduit being configured to connect the user interface to the heated inspiratory conduit;

the medical conduit being configured, when connected to the user interface and the heated inspiratory conduit, to be located in an incubator.

[0013] According to an aspect of this disclosure there is provided a medical conduit configured to deliver breathable gases in a respiratory therapy system; the medical conduit comprising:

a first conduit end connector configured to be connected to a user interface;

a second conduit end connector configured to be connected to a heated inspiratory conduit;

the medical conduit further comprising at least one portion intermediate the first and second conduit end connectors made from a breathable material;

the medical conduit being configured to connect the user interface to the heated inspiratory conduit;

the medical conduit being configured, when connected to the user interface and the heated inspiratory conduit, to be located in an incubator; wherein

the medical conduit is unheated.

[0014] According to an aspect of this disclosure there is provided an incubator breathing gas delivery conduit configured to deliver breathable gases in a respiratory therapy system including an incubator; the medical conduit comprising:

a first conduit end connector configured to be connected to a user interface inside the incubator;

a second conduit end connector configured to be connected to a heated inspiratory conduit outside the incubator;

the incubator breathing gas delivery conduit further comprising at least one portion intermediate the first and second conduit end connectors made from a breathable material.

[0015] The conduit may be unheated, that is, the medical conduit does not comprise any heater to heat gases flowing through the medical conduit.

[0016] The conduit may comprise an elongate film spirally wrapped with an elongate reinforcing member to form a lumen, the elongate film bonding with the elongate reinforcing member.

[0017] The conduit may comprise one or more thermally insulating portions, for example formed by one or more air pockets or other insulating material.

[0018] The at least one portion of the medical conduit may be made from breathable material comprises at least one portion of the elongate film.

[0019] The conduit may be compressible, that is, the length of the conduit can be reduced.

[0020] The conduit may be extensible, that is, the length of the conduit can be increased.

[0021] The conduit may be breathable in that at least part of the conduit is highly permeable to moisture vapor such as water vapor, but is substantially impermeable to liquid moisture such as liquid water and substantially impermeable to the bulk flow of gases.

[0022] The length of the conduit may be between about 20cm and 35cm, and in some configurations is about 25cm. The length of the conduit may be between 10cm and 50cm, in some configurations between 15cm and 40cm, and in some configurations between 20cm and 35 cm.

[0023] The length of the conduit may be less than the length of the heated inspiratory conduit with which the conduit is used.

[0024] The conduit of any one of the preceding claims may define a lumen through the conduit and along which breathable gases flow, the lumen comprising a diameter, the diameter being in the range of 3mm to 40mm, preferably 5mm to 25mm and more preferably 10mm to 20mm.

[0025] The breathable material is advantageous as it helps to manage condensation within the conduit. Condensation can occur due to excess water vapor in the gases passing through the conduit. The breathable material allows transmission of water vapor out of the conduit walls while reducing or preventing transmission of liquid water out of the conduit. The breathable material may be further configured to absorb liquid water into the wall of the conduit. The conduit in the incubator made of breathable material is advantageous because it reduces condensate in the conduit.

[0026] According to an aspect of this disclosure there is provided a respiratory therapy kit for use in a respiratory therapy system, the kit comprising:

a conduit according to any one of the above statements;

a user interface configured to be secured to a user’s head to deliver breathable gases to the user; and

a heated inspiratory conduit configured to receive humidified breathable gases from a humidifier of the respiratory therapy system.

[0027] The user interface may comprise an interface conduit.

[0028] The conduit may comprise:

a first conduit end connector configured to be connected to a connector of the user interface, and a second conduit end connector configured to be connected to an end connector of the heated inspiratory conduit; wherein

the first conduit end connector is also configured to be connectable to the second conduit end connector. The conduit comprises a breathable material.

[0029] The conduit may comprise:

a first conduit end connector configured to be connected to a connector of the user interface, and a second conduit end connector configured to be connected to an end connector of the heated inspiratory conduit; wherein

the end connector of the heated inspiratory conduit is configured to be connected directly to the connector of the user interface, without using the medical conduit.

[0030] One or both ends of a conduit according to any one of the above statements may comprise connector features for releasably connecting the conduit to another

component of a breathing circuit. The connector features may be configured such that the conduit can only be connected in a given orientation in the breathing circuit.

[0031] One end of the conduit may comprise:

a first conduit body; and

one or more locking fingers protruding longitudinally from the conduit body.

[0032] The other end of the conduit may comprise:

a second conduit body; and

one or more locking tabs configured to releasably attach with the one or more locking fingers of the first conduit body, the one or more locking tabs formed on an interior surface of the second conduit body.

[0033] The first or second conduit end connector of the conduit may comprise the first conduit body. The other of the first or second conduit end connector of the conduit may comprise the second conduit body.

[0034] The first conduit end connector may comprise a sensor port for receiving a sensor probe, the sensor port formed substantially perpendicularly adjacent to an aperture on the second conduit body, the aperture configured to receive the connecting adapter into the second conduit body.

[0035] The sensor port may form an opening into an insertion aperture formed by the one or more locking fingers when attached to the first conduit connector, the opening configured to allow the sensor probe to extend into the insertion aperture.

[0036] The sensor port may be formed on the second conduit body such that the ends of the one or more locking fingers extend past the opening formed by the sensor port when attached to the first conduit connector.

[0037] The first conduit end connector may comprise a sensor probe positioned to fit between an insertion aperture formed by the one or more locking fingers.

[0038] The first conduit end connector may comprise a receptacle for receiving a detachable sensor probe, the receptacle formed within the second conduit body, the receptacle configured to position the detachable sensor probe between an insertion aperture formed by the one or more locking fingers.

[0039] Full engagement of the one or more locking tabs with the one or more locking fingers may generate an audible sound.

[0040] The first and second conduit end connectors may be configured to provide a quick connect mechanism between the first conduit end connector and the second conduit end connector.

[0041] An alignment tab may be formed on an interior surface of the second conduit body, the alignment tab configured to automatically align the one or more locking fingers with the one or more locking tabs upon insertion of the second conduit end connector within the first conduit end connector.

[0042] The one or more locking fingers may comprise two locking fingers.

[0043] In an incubator breathing circuit, comprising a conduit according to any one of the above statements, a user interface inside the incubator, and a heated inspiratory conduit outside the incubator, each of the conduit, user interface and heated inspiratory conduit may comprise:

a first conduit body having one or more locking fingers protruding longitudinally from the conduit body; and/or

a second conduit body having one or more locking tabs configured to releasably attach with the one or more locking fingers of the first conduit body, the one or more locking tabs formed on an interior surface of the second conduit body.

[0044] Each of the conduit, user interface, and heated inspiratory conduit comprises connector features that enable each component to be releasably connected to the next. The connector features can be arranged so that each component can only be connected to the appropriate adjacent component, or can be arranged so that each component can be selectively connected to any one or more of the other components.

[0045] In a further aspect of this disclosure, there is provided a connector to be provided at a terminal end of a medical conduit according to any one of the above statements, the connector comprising:

a body, the body comprising a first end and a second end, the body internally defining a lumen for the passage of gas therethrough between each of the first and second ends, the first end, in use, being engaged or engageable with the terminal end of the medical conduit or at least a component to be associated with the terminal end of the medical conduit, and

the second end, in use, to be engaged or engageable with another connector, and wherein an internal surface of the body comprises one or more internal connection features configured for connection with said another connector which may be received internally therein, and

wherein an external surface of the body comprises one or more external alignment feature(s) configured for aligning said connector or another connection into an externally aligned connection therebetween.

[0046] In another aspect of this disclosure, there is provided a connector to be provided at a terminal end of a medical conduit according to any one of the above statements, the connector comprising:

a body, the body comprising a first end and a second end, the body internally defining a lumen for the passage of gas therethrough between each of the first and second ends, the first end, in use, being engaged or engageable with the terminal end of the breathing conduit or at least a component to be associated with the terminal end of the breathing tube, and

the second end, in use, to be engaged or engageable with another connector, and wherein an internal surface of the body comprises one or more internal connection features configured for connection with said another connector which may be received internally therein, and

wherein one or more external visual aid(s) is/are configured for, in use, providing an externally visible guide for alignment of said connector or another connector into an aligned connection therebetween.

[0047] According to the above two aspects, there is provided one or more additional features described by the optional configurations below.

[0048] The one or more internal connection features may be surface feature(s) that extend radially inward from the surface of an internal side wall of the body.

[0049] The one or more internal connection features may comprise one or more tabs.

[0050] The one or more tab(s) may be a raised protrusion.

[0051] The internal connection features may be oriented so as to be radially aligned with said one or more external alignment features and/or said one or more external visual aids.

[0052] There may be a pair of said internal connection features.

[0053] At least one (optionally only one) of said internal connection features may comprise a longitudinally extensive channel or recess, said channel or recess may be configured to locate, retain, or position a printed circuit board (PCB) arrangement.

[0054] The internal surface may comprise one or more internal alignment features configured for aligning at least one connection feature of another connector to be received internally thereof into an aligned connection orientation therewith.

[0055] Said internal surface may comprise one or more internal alignment features configured to, in use, rotatably orient a male connection feature of another connector into an aligned connection orientation for connection with the connector, or at least into connection with, said one or more internal connection features located on or about the internal surface of the body.

[0056] The internal alignment feature(s) may be surface feature(s) that extend radially inward from the surface of an internal side wall of the body.

[0057] The internal alignment feature(s) may comprise one or more tab(s).

[0058] The one or more tab(s) may be a raised protrusion.

[0059] The one or more tab(s) may comprise a pair of shoulders, sloping away from each other and away from an end of the tab at the intersection of the shoulders, the end of the tab located substantially more toward a terminal end of the second end of the connector than the shoulders.

[0060] The internal alignment feature(s) may be one or more ribs extending substantially in a longitudinal direction of said connector and along said internal surface, optionally being a surface of an internal side wall of the body.

[0061] The internal alignment features may comprise: 1-10 ribs, or 2-8 ribs, or 4-6 ribs, or 2 ribs, or 3 ribs, or 4 ribs, or 6 ribs, or 8 ribs, or 10 ribs.

[0062] Two or more sets of internal alignment features may be provided on or about the internal surface of the body, optionally there are two sets of alignment features.

[0063] Each said set of internal alignment may comprise an equal number of internal alignment features as another set.

[0064] The internal surface may comprise two of said internal alignment features.

[0065] The internal alignment features may, in use, rotatably align a pair of fingers extending from another connector when inserted into or placed into engagement or surface contact with said internal surface of the connector.

[0066] The first end may be configured for engagement with the terminal end of the breathing conduit.

[0067] The first end may comprise a sleeved portion to be attached to the terminal end of the breathing conduit and to form a pneumatic connection therewith.

[0068] At least a part of said sleeved portion may be insertable into or to be located or housed within an interior surface or the lumen of the terminal end of the breathing conduit.

[0069] At least a part of said sleeved portion may be receivable upon or to be located or housed upon an exterior surface of the terminal end of the breathing conduit.

[0070] The external alignment feature(s) and/or the external visual aid(s) may comprise one or more external surface features extending radially outwardly from the outer surface of an external side wall of the body.

[0071] The external alignment feature(s) may comprise one or more tab(s).

[0072] The one or more tab(s) may be a raised protrusion.

[0073] The external alignment feature(s) may be one or more rib(s) (or protrusion(s)) extending substantially in a longitudinal direction with the connector and along said external surface, optionally being a surface of an external side wall of the body.

[0074] The at least one, or each rib or protrusion may comprise a pair of shoulders, said shoulders sloping away from each other and away from an end of the rib or protrusion at the intersection of the shoulders, the end of the rib or protrusion located substantially more toward a terminal end of the second end of the connector than the shoulders.

[0075] The at least one, or each rib or protrusion may be substantially tongue shaped, and/or substantially triangular and/or substantially tapers toward an end.

[0076] The external alignment features may comprise: 1-10 ribs, or 2-8 ribs, or 4-6 ribs, or 2 ribs, or 3 ribs, or 4 ribs, or 6 ribs, or 8 ribs, or 10 ribs.

[0077] External alignment features may be spaced, arrayed or arranged evenly or equidistantly from each other about the circumference or a radius of the external surface.

[0078] The external alignment feature may be a projection of a length that extends in a substantially longitudinal direction of said connector and along said external surface, and a height of said projection from the external surface varies along said length.

[0079] [0043] The height of said external alignment feature may taper along said length.

[0080] The height of said projection may either:

a. reduce in a direction extending from a base of the external alignment feature toward a terminal end of the second end of the connector, or

b. increase in a direction extending from a base of the external alignment feature toward a terminal end of the second end of the connector.

[0081] Provided substantially at or toward a base of a or each said external alignment feature may be a stepped protrusion, the stepped protrusion being a more radially outwardly extending projection than an adjacent portion of the external alignment feature.

[0082] The stepped projection may be configured to be co-located or co-locatable for keying with a reciprocally shaped recess or cut-out of at least a part of a sleeved portion of another connector when brought to bear into connection therewith during a connection between the connector and said another connector.

[0083] The stepped projection may be configured to act as a key to

reciprocally locate with a reciprocally shaped recess or cut-out of a component brought into connection therewith.

[0084] Provided substantially at or toward a base of a or each said external alignment feature may be a recess or cut-out, the recess or cut-out configured for receiving a protrusion or projection of a reciprocally sha ped portion of another connector.

[0085] The recess or cut-out may be configured to be co-located or co-locatable for keying with a reciprocal protrusion or projection of at least a part of a sleeved portion of another connector when brought to bear into connection therewith during a connection between the connector and said another connector.

[0086] The recess or cut-out may be configured to act as a key way to reciprocally locate with a reciprocally shaped protrusion or projection of a component brought into connection therewith.

[0087] The stepped protrusion or recess or cut-out may be of the following shapes or profiles for locating with or receiving a substantially reciprocally shaped recess or cut out, or a protrusion or projection: semi-circular, triangular, rectangular or other recti linear or geometric shapes, elliptical, wedge shaped.

[0088] A radially extensive flange or lip may project from the external surface of the body.

[0089] Said flange or lip may substantially defines a stop end for a point or length of maximum engagement of another connector when made with the external surface of the connector.

[0090] Said flange or lip may comprise one or both of:

a. one or more radially and/or longitudinally recessed or grooved regions, or b. one or more radially and/or longitudinally extending projection regions.

[0091] Said flange or lip may be longitudinally extensive so as to be configured for an engagement with the terminal end of the medical conduit.

[0092] According to an aspect of this disclosure there is provided a respiratory therapy kit for use in a respiratory therapy system, the kit comprising:

the conduit of any one of the above statements; and

a heated inspiratory conduit configured to receive humidified breathable gases from a humidifier of the respiratory therapy system;

the medical conduit comprising:

a first conduit end connector configured to be connected to a connector of a user interface of the respiratory therapy system, and a second conduit end connector configured to be connected to an end connector of the heated inspiratory conduit; wherein

the first conduit end connector is also configured to be connectable to the second conduit end connector.

[0093] According to an aspect of this disclosure there is provided a respiratory therapy kit for use in a respiratory therapy system, the kit comprising:

the conduit of any one of the above statements; and

a heated inspiratory conduit configured to receive humidified breathable gases from a humidifier of the respiratory therapy system;

the medical conduit comprising:

a first conduit end connector configured to be connected to a connector of a user interface of the respiratory therapy system, and a second conduit end connector configured to be connected to an end connector of the heated inspiratory conduit; wherein

the end connector of the heated inspiratory conduit is configured to be connected directly to a connector of the user interface, without using the medical conduit.

[0094] The heated inspiratory conduit may comprise a temperature sensor, configured to measure the temperature of breathable gases in the heated inspiratory conduit.

[0095] The connector on the user interface may be substantially identical to the second conduit end connector of the conduit.

[0096] The kit of any one of the above statements may comprise a plurality of incubator gases delivery conduits, wherein at least one incubator gases delivery conduit comprises a diameter of 5mm, at least a second incubator delivery conduit comprises a diameter of 10mm, and at least a third incubator delivery conduit comprises a diameter of 15mm. Additional incubator delivery conduits can be provided with additional diameters. In use, an incubator gases delivery conduit may be selected depending on the size of the user interface, wherein the selected incubator gases delivery conduit diameter corresponds to the diameter of an interface conduit of the user interface.

[0097] An incubator comprising the conduit of any one of the above statements; and/or a respiratory therapy kit of any one of the above statements.

[0098] The heated inspiratory conduit may comprise a temperature sensor, configured to measure the temperature of breathable gases in the heated inspiratory conduit.

[0099] The heated inspiratory conduit may comprise a controller, wherein the controller uses an output of the temperature sensor to control the heat delivered to the breathable gases by the heated inspiratory conduit, the controller controlling the heat delivered based on the dewpoint of the breathable gases.

[00100] The temperature sensor may be positioned outside of the incubator.

[00101] The conduit and the heated inspiratory conduit are may be configured such that the conduit is inside the incubator, and the heated inspiratory conduit is outside of the incubator.

[00102] The second conduit end connector of the conduit may be positioned outside the incubator, when connected to the heated gases conduit.

[00103] The second conduit end connector of the conduit may be positioned inside the incubator, when connected to the heated gases conduit.

[00104] The incubator may comprise an incubation enclosure in which the user is contained in use, and the medical conduit has a length, the length being sufficient to extend from a periphery of the incubation enclosure to the centre of the incubation enclosure.

[00105] According to an aspect of this disclosure there is provided a respiratory therapy system comprising:

a flow generator;

a humidifier;

a heated inspiratory conduit;

a user interface coupled to the gases conduit to deliver a gases flow to a user;

a sensor configured to determine pressure or flow of the gases flow;

a controller configured to control the flow generator to generate the gases flow;

the system further comprising the conduit and/or the respiratory therapy kit of any one of the above statements.

[00106] The heated inspiratory conduit may comprise a temperature sensor, configured to measure the temperature of breathable gases in the heated inspiratory conduit.

[00107] The controller may use an output of the temperature sensor to control the heat delivered to the breathable gases by the heated inspiratory conduit, the controller controlling the heat delivered based on the dewpoint of the breathable gases.

[00108] The respiratory therapy system may be configured for use in an environment comprising both an ambient environment, subject to ambient environment conditions, and a controlled environment subject to at least one controlled parameter, wherein the gases conduit medical conduit is configured to be located in the ambient environment, and the medical conduit is configured, when connected to the gases conduit, to be located in the controlled environment.

[00109] The controlled parameter may be selected from any of:

a. temperature;

b. humidity;

c. pressure;

d. flow

[00110] The user interface may be any one of:

a. a nasal interface configured to seal around the nares or nose of the user; b. an oral mask configured to seal around the mouth of the user;

c. a full face mask configured to seal around both the mouth and nose of the user;

d. a nasal mask, which may be an infant nasal mask; or

e. an unsealed nasal cannula.

[00111] The respiratory therapy system may comprise any one or more further components being:

a. an elbow connector configured to connect a gases conduit to a user interface;

b. a gases conduit;

c. a gases conduit connector configured to connect a gases conduit to another component of the respiratory therapy system.

[00112] The respiratory therapy system may comprise any one or more of:

a. a breathing gas flow generator;

b. a b humidifier for humidifying the breathable gases;

c. a gases conduit, which may or may not be heated; and/or

d. a user interface;

e. a supplementary gases inlet to allow supplementary gases to be introduced into the respiratory therapy system.

[00113] The supplementary gases are preferably delivered upstream of the flow generator. The flow generator may be used to mix the supplementary gases and ambient air or ambient gases that are drawn in through an inlet of the respiratory therapy system by the flow generator. Alternatively the respiratory therapy system may comprise a mixer to mix the supplementary gases and ambient air.

[00114] The respiratory system may comprise a first supplementary gases inlet and a second supplementary gases inlet. The first supplementary gases inlet is a low pressure oxygen inlet. The second supplementary gases inlet may comprise a high pressure gases inlet. A valve may be coupled to the second supplementary gases inlet to control the amount of supplementary gases introduced into the gases flow. The respiratory gases supply comprises a controller to control the flow generator, humidifier and the valve to control the amount of supplementary gases. In one example the valve is controlled to control the oxygen fraction in the gases stream.

[00115] The respiratory gases supply may also comprise one or more sensors that are attached to a patient to measure a patient parameter e.g. the patient’s Sp02 readings. In one example the sensor attached to the patient may be a pulse oximeter that is used to measure the patient’s Sp02. The controller may be configured to control the flow generator to deliver a required or set flow rate. The controller may further be configured to control the valve to maintain an oxygen fraction that achieves a set Sp02 value. The controller is configured to execute a closed loop Sp02 control scheme that attempts to maintain a patient’s Sp02 value by controlling the oxygen fraction within the gases stream.

[00116] The breathable material of the medical conduit may be configured to manage condensation within the conduit, the breathable material allowing transmission of water vapor out of the conduit while reducing or preventing transmission of liquid water out of the conduit.

[00117] The breathable material may be configured to absorb liquid water into the conduit.

[00118] The breathable material may reduce condensate in the conduit.

[00119] When using a medical conduit according to any of the above statements, it can be important that the unheated medical conduit remain inside the incubator, and the heated inspiratory conduit remain outside of the incubator. We have determined that it can therefore be desirable for the connector, connecting the outlet end of the heated inspiratory conduit to the inlet end of the unheated medical conduit to be secured at the boundary of the incubator. To achieve this, once the heated inspiratory tube is located in the correct position, a clip can be provided on the heated inspiratory tube, to clip the heated inspiratory tube to the exterior of the incubator, to resist movement of the heated inspiratory conduit into the incubator, and/or to resist movement of the unheated medical conduit from the incubator. Once so secured, movement of the patient will be less likely to alter the position of the connector.

[00120] According to a further aspect of this disclosure, we provide a component for use with the conduit, kit, and/or respiratory therapy system of any one or more of the above statements, the component comprising a body engageable with one or more external surface recesses of respective one or more conduits, and a pair of jaws extending from the body for gripping an item such that, in use, in a first orientation of the body relative to the respective conduit(s) recesses, the component is movable along a length of the conduit(s), and in a second orientation of the body relative to the respective conduit(s) recesses, the component is resistive to movement along a length of the conduit(s).

[00121] Preferably in use, the body is substantially surrounding of a perimeter of the conduit(s).

[00122] Preferably an internal surface of the body is engageable with the one or more external surface recesses of the conduit(s).

[00123] Preferably in the first orientation the component is in a plane such that the body engageable with external recesses of the respective conduit(s) is substantially co axial with the respective conduit(s), and in the second orientation the component is in a plane such that the body is engageable with external recesses of the respective conduit(s) is substantially non co-axial with the respective conduit(s).

[00124] Preferably one or more portions extend from the body to be engageable with the recesses of the conduit(s).

[00125] Preferably the one or more portions is/are fixed portions.

[00126] Preferably the one or more portions is/are an annular lip or a projection or projections extending from an internal surface of the body.

[00127] Preferably the jaws are opposing upon one another in a closed position.

Preferably the jaws are co-acting upon each other in a closed position.

[00128] Preferably the jaws are hingedly biased toward each other in reaching a substantially closed position.

[00129] Preferably the jaws are openable from a substantially closed position for gripping of an item, openable by deflecting the jaws away from each other.

[00130] Preferably the jaws are openable and grippable of an item for locating of the conduit engaged by the component in a set position.

[00131] Preferably the component is positioned on the conduit(s), such that, when the component is in the second orientation, and the jaws are gripping of an item, the component acts to locate the conduit(s) in a set position.

[00132] Preferably the item comprises one or more of the following: clothing, bedding, structures associated with personal clothing (e.g. personal lanyard, belt) or bedding (e.g. bed frame, mattress), structures associated with medical equipment or where a user is located (e.g. stands, bed side table), incubators, or cots.

[00133] Preferably the body comprises a shoulder portion associated with each jaw of the pair of jaws, the shoulder portion providing a surface for actuation, by a user, of the jaws to an open position.

[00134] Preferably the shoulder portion is an enlarged region of the body.

[00135] Preferably in use, the shoulder portions are deflectable towards each other, such that, in-use, deflection moves the jaws from a closed or substantially closed position to or toward a substantially open position, and release of the deflection allows the hingedly biased jaws to move back to the closed or substantially closed position.

[00136] Preferably the shoulder portions are sized for actuation by fingers of a user, or are finger tabs.

[00137] Preferably one or each jaw comprises grips for gripping of an item.

[00138] Preferably the grips are one or a series of ridges, projections or teeth, such grips being interlockable or interposing with one or more corresponding grips of an opposing jaw.

[00139] Preferably one of more of the grips is shaped to expose one or a series of acute angled portions facing inwardly toward the body.

[00140] Preferably one of more of the grips is shaped to expose one or a series of obtusely angled portions facing outwardly away from the body.

[00141] Preferably the body is configured to be substantially annular about the exterior surface of the, or each, respective conduit(s).

[00142] The system and kit as described earlier may include an expiratory conduit that is coupled to the patient interface and direct exhaled gases away from the patient. The expiratory conduit may direct and carry gases away and out of the incubator. The expiratory conduit may also comprise a breathable material. The breathable material may be similar to the breathable material of the medical conduit that is used between the interface conduit and the inspiratory conduit. The expiratory conduit being made of breathable material allows excess water vapour to be transferred out of the expiratory conduit to reduce or prevent condensation within the expiratory conduit.

BRIEF DESCRIPTION OF THE DRAWINGS

[00143] Throughout the drawings, reference numbers can be reused to indicate general correspondence between reference elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the disclosure.

[00144] Figure 1 shows an example prior art respiratory humidification system for delivering humidified breathable gases to a user, the respiratory therapy system having a breathing circuit that includes an inspiratory circuit comprising a heated inspiratory conduit with a sensor at an end connector of the conduit.

[00145] Figure 2 shows a respiratory therapy system in accordance with an aspect of this disclosure.

[00146] Figure 3 is a first conduit end connector of a medical extension conduit of the system of Figure 2.

[00147] Figure 4 is a second conduit end connector of a medical extension conduit of the system of Figure 2.

[00148] Figure 5 shows an elastomeric outer cover configured for use with the second conduit end connector of Figure 4.

[00149] Figure 6 shows the outer cover of Figure 5 in an assembled configuration with the second conduit end connector of Figure 4.

[00150] Figures 7a to 7e are various views of connection features of conduit connectors in accordance with this disclosure.

[00151] Figure 8 is a perspective cross sectional view of an example medical extension conduit in accordance with this disclosure.

[00152] Figure 9a is a side-plan view of a medical extension conduit incorporating a breathable foamed polymer material; and Figure 9b is cross section view of the medical extension conduit of Figure 9a.

[00153] Figure 10a shows a side-plan view of a section of an example conduit.

[00154] Figure 10b shows a longitudinal cross-section of a top portion a conduit similar to the example conduit of Figure 10a.

[00155] Figure 10c shows another longitudinal cross-section illustrating a first elongate member in a conduit.

[00156] Figure lOd shows another longitudinal cross-section of a top portion of a conduit.

[00157] Figure lOe shows another longitudinal cross-section of a top portion of a conduit.

[00158] Figure 11 shows a transverse cross-section of a second elongate member in a conduit.

[00159] Figures 12-14 illustrate a sequence in which the connector is connected or engaged with another connector.

[00160] Figure 15 is a cross-section through the left-hand end connector of the connector arrangements shown in Figures 12-14.

[00161] Figure 16 shows a graph of the humidity drop against flow rate for various setups of respiratory therapy system.

[00162] Figure 17 shows a graph of the temperature drop against flow rate for various setups of respiratory therapy system.

[00163] Figure 18 is a perspective view of a clip component in use with a conduit in accordance with this disclosure.

[00164] Figure 19 is a side view corresponding to Figure 18.

DETAILED DESCRIPTION

[00165] Certain embodiments and examples of a respiratory therapy system, such a system comprising or for use with an incubator, and medical conduits for such a system, are described herein. Those of skill in the art will appreciate that the disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the disclosure herein disclosed should not be limited by any particular embodiments described herein.

[00166] The disclosure references heater wires, heating elements, and/or heaters in the context of providing heat to a conduit. Heater wire, for example, is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (that is, it is not to be limited to a special or customized meaning) and includes, without limitation, heater strips and/or conductive elements that produce heat when electrical power is provided. Examples of such heating elements include wires made of a conductive metal ( e.g ., copper), conductive polymers, conductive inks printed on a surface of a conduit, conductive materials used to create a track on a conduit, and the like. Furthermore, the disclosure references conduits, limbs, and medical conduits in the context of gas delivery. Conduit, for example, is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and includes, without limitation, passageways having a variety of cross-sections such as cylindrical and non-cylindrical passageways. The disclosed systems and medical conduits can also be used in breathing circuits configured to provide a continuous, variable, or bi level positive airway pressure (PAP) therapy or other form of respiratory therapy such as high flow or low flow oxygen therapy. The breathing circuit may for example comprising an inspiratory circuit which at a minimum includes the inspiratory gases pathway (including all the components) from the gases supply to the user interface.

[00167] When a heated, humidified breathing or gases conduit is used for an incubator or any other temperature (or other parameter) controlled environment (or any region where there is a temperature change, such as around radiant warmers used for burn victims, or under a blanket used by a user), the gases conduit may pass through at least two distinct zones: a lower temperature zone (such as the one outside the incubator, e.g. in ambient air) and a higher temperature zone (such as the one inside the incubator). If the gases conduit is heated by a single heater along its full length, one of the zones will tend to be at an undesirable, unsuitable, or non-optimal temperature, depending on which zone is sensed ( e.g ., which zone contains a temperature sensor). If the heater is controlled to a sensor inside the incubator (such as to a user-end temperature sensor), the section outside the incubator will tend to be too cool, which can lead to condensation in the gases conduit.

[00168] Conversely, if the heater is controlled to a sensor outside the incubator, the section inside the incubator will tend to be too hot, which can lead to overheated gas being provided to the user. This can be particularly undesirable when providing respiratory therapy to infants, such as neonates,, where any excess temperature in the breathing gases delivered to the infant must be avoided. The overheating of the gases can also raise the enthalpy of the gases above a safe limit. This over enthalpy condition should be avoided.

[00169] In a situation where the temperature sensor is outside the incubator, and the temperature of the gases are not accurately controlled, the gases may cool across the conduit portion inside the incubator. This cooling can result in condensation of the water vapour in the gases. This condensation is a risk to a user e.g. an infant within the incubator. The liquid water that has condensed can present a drowning risk and may also present an infection risk, if the liquid water reaches the user. Further the liquid water provides a restriction within the conduit, thereby partially restricting or restricting gases flow through the conduit. This can reduce the effectiveness of the therapy delivered to the patient.

[00170] A typical example of an inspiratory circuit (of a breathing circuit which may or may not also comprise an expiratory circuit) in a respiratory therapy system, includes a heated gases conduit with a temperature sensor located at the user end of said conduit to measure the temperature of the gases flow being provided to the user. An example of such a circuit is described in our earlier patent application PCT publication W02006/019323 (herein WO’323). Another example of such a circuit is described in our earlier patent application PCT publication W02014/077706.

[00171] The respiratory therapy system may include a humidifier (for example, as a standalone humidifier or as part of an integrated humidifier-flow generator). The humidifier heats and humidifies the respiratory gases to a target dewpoint, which are then delivered to the user via the gases conduit. Without heating the gases conduit, the temperature of these gases can then drop as they pass to the user interface. If the temperature of the gases drops below the dewpoint at any point in the inspiratory circuit, then condensation or “rainout” can occur.

[00172] The heated conduit described in WO’323 prevents condensation by heating the gases passing through the conduit. The power supplied to the conduit is regulated by a controller in the device through reference to a temperature signal provided by the temperature sensor located at the user end of the inspiratory conduit. The controller sets a target temperature for the user end of the inspiratory conduit, and then adjusts the power supplied to the conduit based on the difference between said target temperature and the measured value. The target temperature is generally set at or above the measured, estimated, or target dewpoint temperature of the gases exiting the humidifier. The heat produced by the heater wire of the heated conduit is relatively consistent across the length of the conduit, and provided the rate of heat loss is also relatively consistent across the length of the conduit, then the temperature should be maintained above the dewpoint throughout the conduit.

[00173] When receiving respiratory support, infant users, such as neonatal users, are often placed in an incubator, which maintains the environment around the user at a fixed temperature. This environment is typically warmer than the room air (typically incubators are maintained between about 35°C and 37°C), and as such the ambient conditions surrounding the flow path from the device to the user interface become inconsistent along the length of the flow path (i.e. along the length of the inspiratory circuit). If the heated conduit described above was to be connected to user interface inside the incubator, then the user end of the heated conduit comprising the temperature sensor would also be located inside the heated incubator. This would cause the user end of the heated conduit and the temperature sensor to be heated by the incubator itself, resulting in a lower power being required to achieve the target temperature at the temperature sensor.

[00174] Whilst this lower power setting may be enough to achieve the target temperature at the temperature sensor, it might not be enough to maintain the temperature of the gases flow above the dewpoint temperature in the section of the conduit that is located outside of the incubator (i.e. the part of the conduit exposed to ambient environmental conditions). As such, there is a chance of condensation occurring if the circuit is set up in this way. This condensation can be a problem due to lack of sanitation, restricting or blocking the conduit, and/or posing a risk to the user should the liquid be tipped towards the interface. As such, it is desirable to be able to prevent or at least reduce this condensation, for example to help reduce the risk of drowning or infection

[00175] Figure 1 shows an example of a typical prior art respiratory therapy system 1 having a gases source 110 that is either integrated with, or a separate component from, a humidifier 120 comprising a humidifier heater plater 121 and a humidifier fluid chamber 122 having an inlet 123 and an outlet 124. The respiratory therapy system may comprise a housing comprising a casing or enclosure. The gases source 110, such as a blower, and the humidifier 120, may be integrated into the housing. The gases source 110 and humidifier 120 supplies heated and humidified breathable gases to a user U via a breathing circuit that includes, for example, an inspiratory gases conduit 140 for delivery of breathable gases, and a user interface 150. The gases conduit 140 comprises a conduit heater wire 141. In some embodiments, another medical conduit, such as a supply conduit 160, can be used to transport gases from the gases source 110 to the humidifier 120. In some embodiments, an additional medical conduit, such as an interface conduit 170, can connect between the inspiratory conduit 140 and the user interface 180. In some embodiments, a connector 145 can connect between the inspiratory conduit 140 and the interface conduit 170. In some embodiments, exhaled gases can be transported via a medical conduit, such as an expiratory conduit 190. In a bubble CPAP respiratory therapy system 1 as shown in Figure 1, an end of the expiratory conduit 190 distal from the user is immersed in a water reservoir 195, the depth of the immersion in the reservoir 195 determining the pressure generated in the user’s airways. In this system the integrated flow generator and humidifier generates and provides a gases flow at a set flow rate. Further the flow generator may be a blower. The system may comprise pressure relief valves for overpressure relief or the blower may be controlled to prevent an overpressure condition. For example the blower may be switched off if an over pressure is detected by a pressure sensor within the conduit or within the system housing.

[00176] Also add the exhaling of the patient causes bubbling within the reservoir, which can improve the CPAP therapy.

[00177] Figure 1 shows an example of how the respiratory therapy system 1 might be set up in an environment comprising an ambient environment and a controlled environment, where the inspiratory circuit passes through both environments. The controlled environment is shown inside the dashed line in Figure 1, and in this case comprises an incubator I which comprises part of the system 1. The system 1 shown is set up to provide bubble CPAP therapy, but could equally apply to other forms of therapy performed on a user placed inside a heated incubator I, such as nasal high flow therapy. The system 1 could equally be used in any other situation where the inspiratory circuit passes through an environment having varying environmental conditions along the length of the inspiratory circuit.

[00178] Initially, respiratory gases exit the humidifier 120 at point A at a set temperature and humidity (for example, a temperature of 40°C against a dewpoint of 37°C). The respiratory gases would then flow through the inspiratory conduit 140 to point C, located inside the incubator I (represented by the dashed box), at which point the temperature of the respiratory gases is measured. The power supplied to the heated inspiratory conduit 140 is regulated such that the temperature at point C matches the target temperature set by the system controller (for example 40°C). The controller could be in the main housing or enclosure of the device in which the flow generator is located, or may be at any other part of the system, or remote from the system and connected to the system 1 by wired or wireless communication. Similarly the system may comprise more than one controller.

[00179] Due to the presence of the incubator I in the example given, the section of the heated conduit 140 that is located outside of the incubator I (i.e. between points A and B) are exposed to a lower ambient temperature than the section of the heated conduit 140 that is located inside of the incubator I (i.e. between points B and C). This can result in the temperature dropping across the length of the heated conduit 140 between points A and B, before increasing to the target temperature across the length of the heated conduit 140 between points B and C. Depending on factors such as the temperature difference between the incubator I and the room air (i.e. a difference in a parameter between the controlled and ambient environments), it is possible that the temperature in the heated conduit 140 between points A and B may undesirably drop below the dewpoint at one or more locations.

Respiratory Therapy System

[00180] This disclosure relates to modifying the Figure 1 type respiratory therapy system 1 to provide a respiratory therapy system 100 which includes another medical conduit 200 being an extension conduit with a first conduit connector 210 at a first end configured to connect to a connector 145 on the heated inspiratory conduit 140, and a second connector 220 at a second end configured to connect to a connector 185 on the user interface 180.

[00181] During use, substantially all of the entire length of the extension conduit 200 is located within the incubator I (that is, within the controlled environment), with substantially all of the entire length of the heated conduit 170 being located outside of the incubator I (that is, in the ambient or uncontrolled environment).

[00182] An example system 100 using the extension conduit 200 is shown in Figure 2.

In this system 100, the heated inspiratory conduit 140 extends from the outlet 124 of the humidifier 120 (point A) to the boundary of the incubator I (point B) at which point it connects to the extension conduit 200. The extension conduit 200 extends from the boundary of the incubator I (point B) to the connector 185 of the user interface 180 (point C).

[00183] As described above, the power supplied to the heated inspiratory conduit 140 is controlled by a controller, such as the system controller, or any other local or remote controller, based on feedback from a temperature sensor T, located at point B, that is, located outside the incubator I, but as close to the incubator I as possible. As the entire length of the heated inspiratory conduit 140 is exposed to substantially the same ambient conditions, then the temperature of the respiratory gases throughout the entire length of the inspiratory conduit 140 should be above the dewpoint temperature, provided that the set target temperature for the conduit 140 is sufficiently high (as set by the controller in response to a signal indicative of temperature from the temperature sensor T).

[00184] After passing through the heated inspiratory conduit 140 the respiratory gases enter the extension conduit 200, located substantially within the incubator I (that is, within the controlled environment). The extension conduit 200 may be unheated. The extension conduit 200 may be breathable, as discussed in more detail below. The unheated, breathable conduit 200 provides a further length of conduit between the incubator and the interface conduit. The extension conduit 200 may be removably connectable between the inspiratory conduit 140 and the interface conduit 170. As the incubator I may be maintained close to or above the dewpoint temperature of the breathing gases in the inspiratory circuit, any temperature drop across the extension conduit 200 may be too small to cause condensation to occur. At the least the system 100 of Figure 2 should reduce condensate forming in the inspiratory circuit.

Connectors

[00185] The extension conduit 200 comprises a first connector 210 at a first end configured to connect to a connector 145 on the heated inspiratory conduit 140.

Additionally, the extension conduit 200 comprises a second connector 220 at a second end configured to connect to a connector 185 on the user interface 180.

[00186] Furthermore, the connector 145 on the heated inspiratory conduit 140 is configured to connect to the connector 185 on the user interface 180 such that the extension conduit 200 can be removed from the inspiratory circuit when not in use. As such, the first connector 210 may be substantially identical to the connector 185 on the user interface 180. The second connector 220 may be substantially identical to the connector 145 on the heated inspiratory conduit 140. Additionally, as the connector

145 on the heated inspiratory conduit 140 is complementary to the connector 185 on the user interface 180 in order to allow for the inspiratory circuit to be set up without the extension conduit 200, the first and second connectors 210, 220 on the extension conduit 200 are therefore compatible with each other, in that the connectors 210, 220 could be connected together.

[00187] With reference to Figures 3 to 6, each connector 210, 220 connects to the flexible portion of a respective end of conduit 200 via a threaded connector portion 230 on each connector 210, 220. The thread (pitch and inner and outer diameters) on the threaded connector portion 230 corresponds to the internal thread (pitch and inner and outer diameters) of the flexible portion of conduit 200, and can be secured to the flexible portion using an adhesive for example. The threaded connector portion 230 of the connector 210, 220 may be constructed with a relatively slight taper (for example 2°) to allow for a more secure fit between the conduit 200 and the connectors 210,

220. The taper additionally causes a tighter fit at the base of the threaded connector portion 230, and as such the adhesive could be placed in this region. As a result, any expansion and/or swelling of the conduit 200 would be unlikely to cause the threaded connector portion 230 to detach from the flexible portion at the ends of the conduit 200.

[00188] As an alternative to the threaded connection, the flexible portion at the ends of the conduit 200 could be manufactured with a straight tubular portion at one or both ends. In this configuration the connectors 210, 220 could be constructed with a straight (non-threaded) taper to connect to the flexible portion at the ends of conduit 200. An adhesive may or may not be used in this scenario.

[00189] Other methods of attachment of the connectors 210, 220 to the conduit 200 may be used, including, for example, overmoulding part of the connectors 210, 220 to the conduit 200.

[00190] As can best be seen in Figure 3, the first connector 210 may have one or more protrusions or textured regions 215 to allow for greater grip when connecting and disconnecting the extension conduit 200 to/from the heated inspiratory conduit 140.

[00191] With reference to Figures 5 and 6, the second connector 220 can comprise an elastomeric outer sleeve 225. The elastomeric outer sleeve 225 allows for greater grip when connecting and disconnecting the extension conduit 200 to the user interface 180. The sleeve 225 could be constructed as a separate component, and then slid onto the connector 220 to form a composite connector assembly. Alternatively, the sleeve 225 could be overmoulded onto the connector 220. The outer sleeve 225 is configured to surround the outside of the flexible end portion of the extension conduit 200, where the conduit 200 is threaded onto the connector 220.

[00192] One example of such connectors 210, 220 are set out in our earlier patent application PCT publication WO2013/022356 (herein WO’ 356). In particular, the first and second connectors 210, 220 may comprise the locking fingers and locking tabs described in this publication.

[00193] FIGS. 8 A and 8B illustrate perspective views of the connector 210 or 220 from a source aperture 305 side and a terminal aperture 310 side, respectively, incorporating such locking fingers and locking tabs. In the illustrated embodiment, the connector 210 or 220 includes a substantially cylindrical conduit having two locking fingers 153 extending from the source aperture 305. The locking fingers 153 can be spaced apart The connectors 210, 220 may include a slot or opening to insert a temperature sensor within the connector 210, 220. The extension conduit 200 may also comprise a further sensor to measure the temperature at the end of the extension conduit 200. This second temperature sensor reading may be provided to the controller and the signals may be used to control the heater wire in the inspiratory conduit.

[00194] In some embodiments, each locking finger 153 includes a locking recess 154 formed on the outer surface of the locking finger 153. In one embodiment, the locking recesses 154 are configured to lock with the locking tabs of another connector, such as the gases conduit connector 145 or the user interface connector 185. In some embodiments, the locking fingers 153 include a flexible or semi-rigid material such that sufficient longitudinal force can cause the locking recesses 154 to pass over

locking tabs 151 of the source conduit connector 125, thereby releasing the connecting adapter 140 from the source conduit connector 125. For example, pushing the connectors 210, 220 into gases conduit connector 145 or the user interface connector 185 (on assembly or connection) or pulling out the connectors 210, 220 (on disconnection) can cause the locking tabs of the gases conduit connector 145 or the user interface connector 185 to engage or disengage with the locking recesses 154 of the locking finger 153.

[00195] Also consider borrowing broad disclosure and drawings from W02017/037660, e.g. figs 21-23.

[00196] Also include a disclosure of the connector in fig. 28 as a further alternative connector that could be used as the connector to couple to the inspiratory conduit connector.

Conduit Structure

[00197] The length of the extension conduit 200 may be determined by two requirements. First, the extension conduit 200 needs to be long enough to reach from the periphery of an incubator enclosure of the incubator I to the user interface 180. In one example, the extension conduit 200 has a length at least equal to the distance between the periphery of the incubator enclosure, and the centre of the incubator. Secondly, a longer extension conduit 200 will lose a greater amount of heat along its length, as well as a greater amount of humidity if the conduit 200 is breathable (as is described below). As such, it is desirable to make the conduit 200 as short as possible, provided it is not too short to reach the user interface 180 or cause difficulty during the process of setting up the inspiratory circuit. In one configuration, the extension conduit length is between about 20cm and about 35cm. In a further configuration, the extension conduit length is about 25cm. In some configurations the extension conduit length may be between 10cm to 50cm, more preferably between 15cm to 40cm, even more preferably between 20cm and 35 cm.

[00198] The extension conduit 200 can be unheated. The extension conduit being unheated is advantageous because it reduces the chances of a patient (e.g. neonate) inside the incubator being burned. The external wall temperature of the extension tube does not rise to dangerous levels because the extension tube does not have a heater within it.

[00199] The extension conduit 200 also provides a further additional decoupling of the user interface 180 from the inspiratory conduit 140. The extension conduit 200 can move to reduce transfer of forces to the interface if the inspiratory conduit 140 is moved or moves in use. Further the extension conduit 200 can take movement of the interface conduit 140 and reduce transfer of forces to the inspiratory conduit 140 to prevent or reduce the chances of the inspiratory conduit 140 from being dislodged from an opening in the incubator I.

[00200] The extension conduit further helps to stabilise the inspiratory conduit and interface by decoupling the inspiratory conduit from the interface.

CLAIMS

1. A medical conduit configured to deliver breathable gases in a respiratory therapy system; the medical conduit comprising:

i. a first conduit end connector configured to be connected to a user interface;

ii. a second conduit end connector configured to be connected to a heated inspiratory conduit;

iii. the medical conduit further comprising at least one portion intermediate the first and second conduit end connectors made from a breathable material;

iv. the medical conduit being configured to connect the user interface to the heated inspiratory conduit;

the medical conduit being configured, when connected to the user interface and the heated inspiratory conduit, to be located in an incubator.

2. A medical conduit configured to deliver breathable gases in a respiratory therapy system; the medical conduit comprising:

i. a first conduit end connector configured to be connected to a user interface;

ii. a second conduit end connector configured to be connected to a heated inspiratory conduit;

iii. the medical conduit further comprising at least one portion intermediate the first and second conduit end connectors made from a breathable material;

iv. the medical conduit being configured to connect the user interface to the heated inspiratory conduit;

v. the medical conduit being configured, when connected to the user interface and the heated inspiratory conduit, to be located in an incubator; wherein

vi. the medical conduit is unheated.

3. An incubator breathing gas delivery conduit configured to deliver breathable gases in a respiratory therapy system including an incubator; the medical conduit comprising: i. a first conduit end connector configured to be connected to a user interface inside the incubator;

ii. a second conduit end connector configured to be connected to a heated inspiratory conduit outside the incubator;

iii. the incubator breathing gas delivery conduit further comprising at least one portion intermediate the first and second conduit end connectors made from a breathable material.

4. The conduit of claim 1 or 3 wherein the conduit is unheated, that is, the medical conduit does not comprise any heater to heat gases flowing through the medical conduit.

5. The conduit of any one of the preceding claims comprising one or more thermally insulating portions, for example formed by one or more air pockets or other insulating material.

6. The conduit of claim 1 to 5 comprising an elongate film spirally wrapped with an elongate reinforcing member to form a lumen, the elongate film bonding with the elongate reinforcing member.

7. The conduit of claim 6 wherein the at least one portion of the medical conduit which is made from breathable material comprises at least one portion of the elongate film.

8. The conduit of any one of the preceding claims wherein the conduit is compressible, that is, the length of the conduit can be reduced.

9. The conduit of any one of the preceding claims wherein the conduit is extensible, that is, the length of the conduit can be increased.

10. The conduit of any one of the preceding claims wherein the conduit is breathable in that at least part of the conduit is highly permeable to moisture vapor such as water vapor, but is substantially impermeable to liquid moisture such as liquid water and substantially impermeable to the bulk flow of gases.

11. The conduit of any one of the preceding claims wherein the length of the conduit is between about 20cm and 35cm, and in some configurations is about 25cm.

12. The conduit of any one of claims 1 to 10 wherein the length of the conduit is between 10cm and 50cm, in some configurations between 15cm and 40cm, and in some configurations between 20cm and 35 cm.

13. The conduit of any one of the preceding claims wherein the length of the conduit is less than the length of the heated inspiratory conduit with which the conduit is used.

14. A respiratory therapy kit for use in a respiratory therapy system, the kit comprising:

i. a conduit according to any one of claims 1 to 13;

ii. a user interface configured to be secured to a user’s head to deliver breathable gases to the user; and

iii. a heated inspiratory conduit configured to receive humidified breathable gases from a humidifier of the respiratory therapy system.

15. The respiratory therapy kit of claim 14 wherein the user interface comprises an interface conduit.

16. The respiratory therapy kit of claim 14 or 15 wherein the conduit comprises:

i. a first conduit end connector configured to be connected to a connector of the user interface, and a second conduit end connector configured to be connected to an end connector of the heated inspiratory conduit; wherein

ii. the first conduit end connector is also configured to be connectable to the second conduit end connector.

17. A respiratory therapy kit of claim 14 or 15 wherein the conduit comprises:

i. a first conduit end connector configured to be connected to a connector of the user interface, and a second conduit end connector configured to be connected to an end connector of the heated inspiratory conduit; wherein

ii. the end connector of the heated inspiratory conduit is configured to be connected directly to the connector of the user interface, without using the medical conduit.

18. A respiratory therapy kit for use in a respiratory therapy system, the kit comprising:

i. the conduit of any one of claims 1 to 13; and

ii. a heated inspiratory conduit configured to receive humidified breathable gases from a humidifier of the respiratory therapy system; iii. the medical conduit comprising:

i. a first conduit end connector configured to be connected to a connector of a user interface of the respiratory therapy system, and a second conduit end connector configured to be connected to an end connector of the heated inspiratory conduit; wherein the first conduit end connector is also configured to be connectable to the second conduit end connector.

19. A respiratory therapy kit for use in a respiratory therapy system, the kit comprising:

i. the conduit of any one of claims 1 to 13; and

ii. a heated inspiratory conduit configured to receive humidified breathable gases from a humidifier of the respiratory therapy system; iii. the medical conduit comprising:

a first conduit end connector configured to be connected to a connector of a user interface of the respiratory therapy system, and a second conduit end connector configured to be connected to an end connector of the heated inspiratory conduit; wherein

the end connector of the heated inspiratory conduit is configured to be connected directly to a connector of the user interface, without using the medical conduit.

20. The respiratory therapy kit of any one of claims 14 to 19 wherein the heated inspiratory conduit comprises a temperature sensor, configured to measure the temperature of breathable gases in the heated inspiratory conduit.

21. The respiratory therapy kit of any one of claims 14 to 20 wherein the connector on the user interface is substantially identical to the second conduit end connector of the conduit.

22. An incubator comprising the conduit of any one of claims 1 to 13; and/or a respiratory therapy kit of any one of claims 14 to 21.

23. The incubator of claim 22 wherein the heated inspiratory conduit comprises a temperature sensor, configured to measure the temperature of breathable gases in the heated inspiratory conduit.

24. The incubator of claim 23 comprising a controller, wherein the controller uses an output of the temperature sensor to control the heat delivered to the breathable gases by the heated inspiratory conduit, the controller controlling the heat delivered based on the dewpoint of the breathable gases.

25. The incubator of claim 24 wherein the temperature sensor is positioned outside of the incubator.

26. The incubator of any one of claims 22 to 25 wherein the conduit and the heated inspiratory conduit care configured such that the conduit is inside the incubator, and the heated inspiratory conduit is outside of the incubator.

27. The incubator of claim 26 wherein the second conduit end connector of the conduit is positioned outside the incubator, when connected to the heated gases conduit.

28. The incubator of claim 26 or 27 wherein the second conduit end connector of the conduit is positioned inside the incubator, when connected to the heated gases conduit.

29. The incubator of any one of claims 22 to 28, wherein the incubator has an incubation enclosure in which the user is contained in use, and the medical conduit has a length, the length being sufficient to extend from a periphery of the incubation enclosure to the centre of the incubation enclosure.

30. A respiratory therapy system comprising:

i. a flow generator;

ii. a humidifier;

iii. a heated inspiratory conduit;

iv. a user interface coupled to the gases conduit to deliver a gases flow to a user;

v. a sensor configured to determine pressure or flow of the gases flow; vi. a controller configured to control the flow generator to generate the gases flow;

vii. the system further comprising the conduit of any one of claims 1 to 13;

and/or a respiratory therapy kit of any one of claims 14 to 21.

31. The respiratory therapy system of claim 30 wherein the heated inspiratory conduit comprises a temperature sensor, configured to measure the temperature of breathable gases in the heated inspiratory conduit.

32. The respiratory therapy system of claim 31 wherein the controller uses an output of the temperature sensor to control the heat delivered to the breathable gases by the heated inspiratory conduit, the controller controlling the heat delivered based on the dewpoint of the breathable gases.

33. The respiratory therapy system of any one of claims 30 to 32 configured for use in an environment comprising both an ambient environment, subject to ambient environment conditions, and a controlled environment subject to at least one controlled parameter, wherein the gases conduit medical conduit is configured to be located in the ambient environment, and the medical conduit is configured, when connected to the gases conduit, to be located in the controlled environment.

34. The respiratory therapy system of claim 33 wherein the controlled parameter is selected from any of:

i. temperature;

ii. humidity;

iii. pressure;

iv. flow.

35. The respiratory therapy system of any one of claims 30 to 34 wherein the breathable material is configured to manage condensation within the conduit, the breathable material allowing transmission of water vapor out of the conduit while reducing or preventing transmission of liquid water out of the conduit.

36. The respiratory therapy system of claim 35 wherein the breathable material is configured to absorb liquid water into the conduit.

37. The respiratory therapy system of claim 35 or 36 wherein the breathable material reduces condensate in the conduit.

Documents

Application Documents

# Name Date
1 202217035756-FORM 18 [21-12-2023(online)].pdf 2023-12-21
1 202217035756.pdf 2022-06-22
2 202217035756-TRANSLATIOIN OF PRIOIRTY DOCUMENTS ETC. [22-06-2022(online)].pdf 2022-06-22
2 202217035756-AMMENDED DOCUMENTS [20-12-2023(online)].pdf 2023-12-20
3 202217035756-STATEMENT OF UNDERTAKING (FORM 3) [22-06-2022(online)].pdf 2022-06-22
3 202217035756-Annexure [20-12-2023(online)].pdf 2023-12-20
4 202217035756-PRIORITY DOCUMENTS [22-06-2022(online)].pdf 2022-06-22
4 202217035756-FORM 13 [20-12-2023(online)].pdf 2023-12-20
5 202217035756-NOTIFICATION OF INT. APPLN. NO. & FILING DATE (PCT-RO-105-PCT Pamphlet) [22-06-2022(online)].pdf 2022-06-22
5 202217035756-MARKED COPIES OF AMENDEMENTS [20-12-2023(online)].pdf 2023-12-20
6 202217035756-RELEVANT DOCUMENTS [20-12-2023(online)].pdf 2023-12-20
6 202217035756-FORM 1 [22-06-2022(online)].pdf 2022-06-22
7 202217035756-FIGURE OF ABSTRACT [22-06-2022(online)].jpg 2022-06-22
7 202217035756-Correspondence-300922.pdf 2022-10-25
8 202217035756-Others-300922.pdf 2022-10-25
8 202217035756-DRAWINGS [22-06-2022(online)].pdf 2022-06-22
9 202217035756-FORM 3 [11-10-2022(online)].pdf 2022-10-11
9 202217035756-DECLARATION OF INVENTORSHIP (FORM 5) [22-06-2022(online)].pdf 2022-06-22
10 202217035756-COMPLETE SPECIFICATION [22-06-2022(online)].pdf 2022-06-22
10 202217035756-Proof of Right [28-09-2022(online)].pdf 2022-09-28
11 202217035756-Correspondence-090922.pdf 2022-09-16
11 202217035756-FORM-26 [01-09-2022(online)].pdf 2022-09-01
12 202217035756-GPA-090922.pdf 2022-09-16
13 202217035756-Correspondence-090922.pdf 2022-09-16
13 202217035756-FORM-26 [01-09-2022(online)].pdf 2022-09-01
14 202217035756-COMPLETE SPECIFICATION [22-06-2022(online)].pdf 2022-06-22
14 202217035756-Proof of Right [28-09-2022(online)].pdf 2022-09-28
15 202217035756-DECLARATION OF INVENTORSHIP (FORM 5) [22-06-2022(online)].pdf 2022-06-22
15 202217035756-FORM 3 [11-10-2022(online)].pdf 2022-10-11
16 202217035756-DRAWINGS [22-06-2022(online)].pdf 2022-06-22
16 202217035756-Others-300922.pdf 2022-10-25
17 202217035756-Correspondence-300922.pdf 2022-10-25
17 202217035756-FIGURE OF ABSTRACT [22-06-2022(online)].jpg 2022-06-22
18 202217035756-FORM 1 [22-06-2022(online)].pdf 2022-06-22
18 202217035756-RELEVANT DOCUMENTS [20-12-2023(online)].pdf 2023-12-20
19 202217035756-MARKED COPIES OF AMENDEMENTS [20-12-2023(online)].pdf 2023-12-20
19 202217035756-NOTIFICATION OF INT. APPLN. NO. & FILING DATE (PCT-RO-105-PCT Pamphlet) [22-06-2022(online)].pdf 2022-06-22
20 202217035756-PRIORITY DOCUMENTS [22-06-2022(online)].pdf 2022-06-22
20 202217035756-FORM 13 [20-12-2023(online)].pdf 2023-12-20
21 202217035756-Annexure [20-12-2023(online)].pdf 2023-12-20
22 202217035756-AMMENDED DOCUMENTS [20-12-2023(online)].pdf 2023-12-20
23 202217035756-FORM 18 [21-12-2023(online)].pdf 2023-12-21
24 202217035756-FER.pdf 2025-10-10

Search Strategy

1 202217035756_SearchStrategyNew_E_SearchHistory(1)E_09-10-2025.pdf