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(51) International Patent Classification: Auckland, 2013 (NZ). MATTHEWS, Cameron Leslie; 15
A61M 16/16 (2006.01) A61M 16/08 (2006.01) Maurice Paykel Place, East Tamaki, Auckland, 2013 (NZ).
A61M 16/00 (2006.01) A61M 16/10 (2006.01) MASSEY, Shane Terry; 15 Maurice Paykel Place, East
A61M 1/00 (2006.01) Tamaki, Auckland, 2013 (NZ).
(21) International Application Number: (74) Agent: AJ PARK; Level 22, Aon Centre, 1 Willis Street,
PCT/IB20 19/057304 Wellington, 601 1 (NZ).
(22) International Filing Date: (81) Designated States (unless otherwise indicated, for every
30 August 2019 (30.08.2019) kind of national protection av ailable) . AE, AG, AL, AM,
AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ,
(25) Filing Language: English
CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO,
(26) Publication Language: English DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN,
HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP,
(30) Priority Data:
KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME,
62/724,995 30 August 2018 (30.08.2018) US
MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ,
(71) Applicant: FISHER & PAYKEL HEALTHCARE OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA,
LIMITED [NZ/NZ]; 15 Maurice Paykel Place, East Tama- SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN,
ki, Auckland, 2013 (NZ). TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.

(72) Inventors: WHITE, Craig Karl; 15 Maurice Paykel Place, (84) Designated States (unless otherwise indicated, for every
East Tamaki, Auckland, 2013 (NZ). MCDERMOTT, kind of regional protection available) . ARIPO (BW, GH,
Gareth Thomas; 15 Maurice Paykel Place, East Tamaki, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ,

(54) Title: A HUMIDIFICATION ASSEMBLY

(57) Abstract: This invention relates to a humidification assembly or kit for use in a respiratory support system for delivering humidified
gas to a user or patient. The assembly or kit comprises a fluid reservoir, and a humidification chamber. The fluid reservoir and the
humidification chamber are provided in fluid connection with each other, wherein a connection between each of the fluid reservoir
and the humidification chamber provides a pre-determined force of retention and/or resistance to disconnection or is a permanent type
connection.

[Continued on next page]


A HUMIDIFICATION ASSEMBLY

TECH NICAL FIELD

[0001 ] This disclosure relates t o various humid ification assembl ies, f l uid conta i ners,
cond uits, a nd humid ification cha mbers, a nd pa rticula rly t o perma nent connections
between f l uid reservoi rs a nd humid ification chambers. The humid ification assembl ies
i ncl ude connections that a re permanent or del iberately difficult t o remove, where remova l
may ca use damage t o the con nection or assembly components. The disclosure also
relates t o connectors t o faci litate the perma nent or end uri ng connection of f l u id
reservoirs, such as water bags, t o hum id ification cha mbers.

BACKGROUND ART

[0002 ] Known f l uid reservoi rs a nd accessories such as humid ifier cha mbers or
infusion pu mps have a cond uit or tubi ng that is free t o connect t o other flu id reservoi rs or
accessories. This is beca use permanent connections at both ends of a cond uit is usua lly
not desi ra ble. A benefit of known fluid reservoi rs not havi ng permanent connections is
that the cond uit (and patient) often needs t o be p l ugged into a series of successive bags
of the sa me or different flu ids (such as water, med ica ment, or intravenous (IV) f l u ids) .
Thus, in this case, remova ble connections a re provided at either end of the cond uit a nd
a re preferred for optiona lity a nd choice in which f l uid t o provide t o a patient at a given
t i me, without the need t o clean the ad m i nistration eq u i pment from the prior f l uid or t o
provide a new set of ad m i nistration eq u i pment.

[0003 ] However, for hu mid ifiers in an operati ng theatre situation, this is not
necessa r i ly the case. I n this situation, water is usua lly the only f l uid in commu nication
with the humidification chamber.

[0004] Usi ng known flu id bags, there exists a risk that a user, such as a nurse,
cli nicia n, or other medica l professiona l, in a theatre situation, could accidently spi ke an
incorrect f l uid bag for an accessory, for exa mple sa li ne for the humid ifier or water for an
infusion pu mp or IV dri p . If this accidenta l spi k i ng were t o occur in theatre, where it may
be li kely t o as it is a busy and/or stressful envi ronment, then an IV f l uid such as sa l ine
could be introd uced into the humidification cha mber of a humid ifier, a nd conversely
d isti l led water could be introduced into a patient intravenously.

[0005 ] This issue is com pounded beca use hypotonic water bags a nd sa li ne bags look
very s i m i la r . Another compound i ng factor is that there a re no sta nda rds in terms of
la bel li ng of different f l uid bags. I n some countries, the wordi ng for sa li ne bags is bl ue in
colour, but a bl ue word i ng could be used for hypotonic water in other countries.

[0006] Sa li ne is a commonly used intravenous flu id . Typica lly, norma l sa li ne is a


sodi um ch loride sol ution at 0.9% concentration . This concentration is close t o the
concentration in blood so sal i ne is isotonic. If sa li ne is accidenta l ly used with a
humid ification system then when water eva porates, salt is left behi nd . This sa lt ca n ca use
problems with the function of the humid ification system as it may get into a nd da mage
component pa rts, degrade sensors etc. For exa m ple, sa lt bui ld up has shown t o impede
sensor read i ngs a nd va lve f u nctions, which ca n result in overfi ll ing of a hu mid ification
cha mber. This could become a safety haza rd in the operati ng theatre/room .

[0007 ] If hypotonic water is introduced into the patient i nstead of the intended
sa li ne, then the patient's blood can become hypoton ic, with too low a sol ute
concentration, a nd hemolysis of the red blood cells and/or cytolysis of other cel ls may
occur. Hemolysis is the rupturi ng of red blood cel ls, a nd it ca n resu lt in decreased oxygen
supply t o the rest of the body.

[0008] As outl i ned above, commonly used hypotonic water a nd sa l ine bags look
sim ilar, t h us i ncreasing the risk of mixing these bags, a nd adm inistering an incorrect bag
t o a patient ( i .e. hypoton ic water in IV, and/or sa li ne in humidification) . Hypotonic water
already exists in bottles in theatre for other reasons, a nd these bottles a re easily
discernible from IV bags.

[0009 ] I n this specification, where reference has been made t o externa l sources of
information, i ncl ud i ng patent specifications a nd other documents, this is genera lly for the
purpose of provid i ng a context for d iscussi ng the features of the present invention .
Unless stated otherwise, reference t o such sources of information is not t o be construed,
in any j urisd iction, as an ad mission that such sources of information a re prior art or form
pa rt of the common genera l knowledge in the art.

SUMMARY

[00 10] It is an object of t h is disclosure t o provide a f l uid reservoi r perma nently


connected t o a cond uit (tubi ng), in turn perma nently connected t o a humid ification
cha mber, or a fluid reservoi r in a perma nent connection with a humidification cha mber
(such a permanent connection bei ng provided in a ma nner such that the connections
provide for a sufficient resista nce t o disconnection or a con nection w h ich is severed upon
disconnection) which goes at least some way towards overcomi ng one or more of the
a bove mentioned problems or difficulties, or t o provide the i nd ustry/publ ic with a useful
choice.
[ 0011 ] Hypotonic water already exists in bottles in theatre for other reasons, and
these bottles are easily discernible from IV bags. This invention allows this hypotonic
water t o be used t o fill/refill a water bag connected t o a humidification chamber. This
invention removes the need t o have the fluid bags containing hypotonic water in theatre,
because pre-existing bottles of water may be used t o fill up the water bag of this
invention instead. Removing these hypotonic water bags would prevent any confusion
and thus remove the risk of putting water into the patient instead of saline, and saline
into the humidifier instead of water.

[ 0012 ] Therefore, this invention provides an ideal humidification system for a busy
and/or stressful theatre environment that prevents saline accidentally being delivered t o
the humidifier and water accidently being delivered t o the patient.

[ 0013 ] I n accordance with at least one of the embodiments disclosed herein, a


humidification assembly or kit for use in a respiratory support system for delivering
humidified gas t o a user or patient comprises, a humidification chamber, a fluid reservoir
for supplying fluid t o the humidification chamber, and wherein the humidification
chamber and fluid reservoir are permanently connectable via a tubing.

[ 0014 ] I n a first aspect there is provided a humidification assembly or kit for use in
a respiratory support system for delivering humidified gas t o a user or patient,
comprising:

a fluid reservoir, and


a humidification chamber,
wherein the fluid reservoir and the humidification chamber are provided in fluid
connection with each other, and
wherein, a connection between each of the fluid reservoir and the humidification
chamber provides a pre-determined force of retention and/or resistance t o disconnection.

[ 0015 ] The connection between each of the fluid reservoir and the humidification
chamber may provide for a pre-determined force of retention and/or resistance t o
disconnection such that said connection is destructively severed upon application of a
disconnection force above said pre-determined force.

[ 0016 ] A part or component of the humidification assembly or kit may be destroyed


when the connection is subject t o a disconnection force above said pre-determined force.

[ 0017 ] I n a second aspect there is provided a humidification assembly or kit for use
in a respiratory support system for delivering humidified gas t o a user or patient,
comprising:
a fluid reservoir,
a humidification chamber,
wherein in the fluid reservoir and the humidification chamber are provided in
permanent fluid connection with each other.

[0018] I n a third aspect there is provided a humidification assembly or kit for use in
a respiratory support system for delivering humidified gas t o a user or patient,
comprising:

a humidification chamber configured for receiving a source of humidification fluid,


a fluid reservoir configured for providing the source of humidification fluid for
supply t o the humidification chamber, and
wherein a permanent connection is provided for a fluid connection between the fluid
reservoir and the humidification chamber.

[0019] A device may provide for a fluid connection from the fluid reservoir and the
humidification chamber.

[0020] The device providing for the fluid connection may be a conduit.

[0021] I n a fourth aspect there is provided a humidification assembly or kit for use
in a respiratory support system for delivering humidified gas t o a user or patient,
comprising:

a humidification chamber configured for receiving a source of humidification fluid,


a fluid reservoir configured for providing the source of humidification fluid for
supply t o the humidification chamber,
a conduit provided as an interconnect between the humidification chamber and
the fluid reservoir configured for providing the source of humidification fluid, and
wherein, a connection is provided as a permanent connection between each of:
- the conduit and the humidification chamber, and
- the conduit and the fluid reservoir.

[0022] I n a fifth aspect there is provided a humidification assembly or kit for use in
a respiratory support system for delivering humidified gas t o a user or patient,
comprising:

a humidification chamber configured for receiving a source of humidification fluid,


a fluid reservoir configured for providing the source of humidification fluid for
supply t o the humidification chamber,
a conduit provided as an interconnect between the humidification chamber and
the fluid reservoir configured for providing the source of humidification fluid, and
wherei n, a connection is provided with a pre-determi ned force of retention and/or
resista nce t o disconnection between each of:
- the cond uit a nd the hu mid ification cha mber, a nd
- the cond uit a nd the flu id reservoi r .

[0023 ] The fol lowi ng features may be provided in combi nation with any one or more
of the above aspects or features as disclosed herei n.

[0024] The con nection may be one or more of:

- config ured such that, the or a cond uit provid i ng for the f l uid communication is resistant
to, or una ble t o be disconnected,
- configured such that disconnection results in da mage t o the f l uid communication,
- configured such that separation or disconnection of the connection serves t o
destructively sever the connection,
- configured such that separation or disconnection of the connection is destructive of one
or more components or pa rts which formed the con nection,
- configured such that separation or disconnection of the connection serves t o prevent a
subseq uent re-esta bl ishment of a connection .

[0025 ] A f i rst end of the condu it may be con nected or coupled t o the f l uid reservoir,
or a component con nected t o or coupled t o the f l uid reservoir.

[0026] A second end of the cond uit may be connected or coupled t o the
humid ification cha mber or a component con nected t o or coupled t o the humid ification
cha mber.

[0027 ] The conduit may be provided as the f l uid con nection between the f l u id
reservoir a nd the humidification cha mber, a nd may be config ured for provid i ng the
source of humid ification f l uid .

[0028] The conduit may be provided as a f l uid interconnect between the


humid ification cha mber a nd the f l uid reservoi r config u red for provid i ng the source of
humid ification f l uid, a nd the connection may be esta bl ished between each of:

- the cond uit a nd the hu mid ification cha mber, a nd


- the cond uit a nd the flu id reservoi r .

[0029 ] The connection between the cond uit a nd humid ification cha mber may be
made by one or more of:

- a ba rbed-type con nector,


- a structu ra l formation provid i ng for a physica l inter-connect,
- an interference or friction fit or push-fit,
- an adhesive,
- solvent bond i ng,
- heat sea l ing,
- a threaded connection .

[0030] The con nection between the cond uit a nd sa id f l uid reservoi r may be made by
one or more of:

- a ba rbed-type con nector,


- a structu ra l formation provid i ng for a physica l inter-connect,
- an interference or friction fit or push-fit,
- an adhesive,
- solvent bond i ng,
- heat sea l ing,
- a threaded connection .

[0031 ] A f l u id reservoi r end of sa id conduit may comprise a f l uid reservoi r connector


t o provide the connection between sa id device or sa id the cond uit a nd the f l uid reservoi r .

[0032 ] A humid ification cha mber end of sa id cond uit may comprise a hu mid ification
cha mber connector t o provide the con nection between the cond uit a nd the humid ification
cha mber.

[0033 ] The conduit may comprise :

- a f l uid reservoi r connector at a f l uid reservoi r end of sa id cond uit, and


- a hum id ification cha mber connector at a humid ification cha mber end of sa id
cond uit,
wherei n each of sa id f l uid reservoi r connector a nd sa id humid ification cha mber
connector may provide sepa rately made con nections between the cond uit a nd the flu id
reservoir a nd the cond uit a nd the humidification cha mber.

[0034] The f l uid reservoi r con nector may be connected t o the f l uid reservoi r end of
sa id cond uit.

[0035 ] The f l uid reservoi r connector may provide a hermetic connection between the
cond uit a nd the flu id reservoi r .

[0036] The f l uid reservoi r con nector may be connected t o the f l uid reservoi r end of
sa id cond uit by one or more of:
- a ba rbed -type fit,
- a structu ra l formation provid i ng for a physica l inter-connect,
- an interference or friction fit or push-fit,
- an adhesive,
- solvent bond i ng,
- heat sea l ing,
- a threaded connection .

[0037 ] The humid ification chamber connector may be connected t o the


humid ification cha mber end of sa id conduit.

[0038] The humid ification chamber connector may provide a hermetic connection
between the cond uit a nd the humid ification cha mber.

[0039 ] The humid ification chamber connector may be connected t o the


humid ification cha mber end of sa id conduit by one or more of:

- a ba rbed -type fit,


- a structu ra l formation provid i ng for a physica l inter-connect,
- an interference or friction fit or push-fit,
- an adhesive,
- solvent bond i ng,
- heat sea l ing,
- a threaded connection .

[0040] The f l uid reservoi r con nector and/or the h umid ification cha mber connector
may comprise a lead-i n portion substantia lly at or towa rd one end of sa id connector, sa id
lead-i n portion t o facil itate a connection between :

- the f l uid reservoi r connector a nd the f l uid reservoir, and/or


- the humid ification cha mber connector a nd the hu mid ification cha mber.

[0041 ] The lead-i n portion may be a t a pered reg ion .

[0042 ] The lead-i n portion may be sha ped so as t o faci litate the subseq uent
esta bl ishment of connection .

[0043 ] The t a pered region may be t a pered t o provide for a relatively na rrowed neck
of a relatively sma ller d ia meter t o receive sa id condu it or t o be received by the f l uid
reservoir or the humid ification cha mber.
[0044] The f l uid reservoi r con nector and/or the humidification cha mber con nector
may be substa ntia l ly flexi ble or substa ntia lly conforma ble or substantia lly non-rig id .

[0045 ] The f l uid reservoi r con nector and/or the humidification cha mber con nector
may be substantia lly inflexi ble or substa ntia l ly non-conforma ble or substa ntia lly rig id .

[0046] The f l uid reservoi r con nector and/or the humid ification cha mber connector
may be substa ntia l ly rig id, a nd optiona lly may be formed of a polypropylene.

[0047 ] The f l uid reservoi r con nector may be a substa ntial ly long itud i na l component
comprisi ng a first end config ured t o be received by the f l uid reservoir, a nd a second end
configu red t o be received by the conduit.

[0048] The f l uid reservoi r connector may com prise a lead-i n portion at or towa rd the
f i rst end .

[0049 ] The f l uid reservoi r connector may com prise a ba rb-type portion at or towa rd
the second end .

[0050] The ba rb-type portion may be config ured t o reta in sa id condu it once sa id
connection is esta bl ished .

[0051 ] At least one radial ly outwa rd projection may extend from an outer surface of
the f l uid reservoi r connector, sa id at least one rad ia lly outwa rd projection may be located
intermed iate of the lead-i n portion a nd the second end .

[0052 ] The at least one rad ia lly outwa rd projection may be or comprise of a barb-
type a rra ngement, configu red t o reta in sa id f l uid reservoi r once sa id connection is
esta bl ished .

[0053 ] A lead i ng edge or lead i ng su rface of sa id at least one outwa rd projection may
be lead i ng with respect t o an edge or su rface of the projection (s) w h ich is/a re t o
preferentia l ly ma ke contact with sa id f l uid reservoi r .

[0054] A colla r may be located intermed iate of the at least one rad ia lly outwa rd
projection a nd the second end .

[0055 ] The col la r may provide for at least two seating su rfaces, a first of said
seati ng surfaces provided t o substa ntia lly face towa rd the f i rst end a nd a second of sa id
seati ng surfaces provided t o substa ntia lly face towa rd the second end .

[0056] Each seati ng surface of the at least two seati ng surfaces may be provided as
a conti nuous or disconti nuous surface.
[0057 ] The col la r may be an a nnula r col la r.

[0058] The colla r may extend radia lly outwa rdly from the outer surface of the f l uid
reservoir con nector, the col la r dimensioned t o have a long itud i na l thickness config u red t o
sepa rate a termi na l end of the cond uit from a f l u id reservoi r connection poi nt.

[0059 ] The col la r may be a thickened ba nd reg ion of the f l uid reservoi r con nector.

[0060] A lead i ng edge or lead i ng su rface of sa id at least one outwa rd projection may
be lead i ng with respect t o an edge or su rface of the projection (s) w h ich is/a re t o
preferentia lly ma ke contact with sa id f l uid reservoi r .

[0061 ] The at least one rad ia lly outwa rd projection may extend outwa rdly of the
outer surface t o a substa ntia lly lesser extent or dia meter tha n sa id col la r .

[0062 ] The colla r may extend substa ntia lly rad ia lly outwardly of the outer su rface t o
a substa ntia lly greater extend, extent, or d ia meter than sa id outwa rd projection .

[0063 ] The ba rb-type portion may be located substa ntia lly at or towa rd sa id second
end, a nd may be located intermed iate of the col la r a nd the second end .

[0064] The externa l d ia meter of the connector between the second end of sa id
con nector a nd the collar may comprise a f i rst long itud i na l length diameter a nd a second
long itud i na l d ia meter, the first long itudi na l dia meter may be substantial ly sma ller tha n
the second long itud i na l d ia meter, wherei n the f i rst long itud i na l d ia meter may be at the
second end a nd the second long itud i na l d ia meter may be long itudi na lly d isplaced from
the second end a nd more towa rd the col la r .

[0065 ] The ba rb-type portion may be located with in a region of the f i rst long itud ina l
length d ia meter.

[0066] The f l uid reservoi r con nector and/or the humidification cha mber connector
may comprise a lumen or passageway for ena bl i ng f l uid communication between the f irst
end a nd the second end .

[0067 ] A force requ ired t o sepa rate the f l uid reservoi r con nector and/or the
humid ification cha mber connector a nd the cond uit may be at least about 20N .

[0068] A force requ ired t o sepa rate the f l uid reservoi r con nector and/or the
humid ification cha mber connector a nd the cond uit may be at least about 30N .

[0069 ] A force requ ired t o sepa rate the f l uid reservoi r con nector and/or the
humid ification cha m ber connector a nd the cond uit may be about 20N t o about 1 10N .
[0070] A force requ ired t o sepa rate the f l uid reservoi r con nector and/or the
humid ification cha mber connector a nd the cond uit may be about 30N t o about 100N .

[0071 ] A force requ ired t o sepa rate the f l uid reservoi r con nector a nd the f l uid
reservoir may be at least about 20N .

[0072 ] A force requ ired t o sepa rate the f l uid reservoi r con nector a nd the f l uid
reservoir may be at least about 30N .

[0073 ] A force requ ired t o sepa rate the f l uid reservoi r con nector a nd the f l uid
reservoir may be about 20N t o about 200N .

[0074] A force requ ired t o sepa rate the f l uid reservoi r con nector a nd the f l uid
reservoir may be about 30N t o about 100N .

[0075 ] A force req uired t o sepa rate the cond uit a nd the humid ification cha mber
and/or f l uid reservoi r may be at least about 20N .

[0076] A force req uired t o sepa rate the cond uit a nd the humid ification cha mber
and/or f l uid reservoi r may be at least about 30N .

[0077 ] A force req uired t o sepa rate the cond uit a nd the humid ification cha mber
and/or f l uid reservoir may be about 20N t o about 1 10N .

[0078] A force req uired t o sepa rate the cond uit a nd the humid ification cha mber
and/or f l uid reservoir may be about 30N t o about 100N .

[0079 ] A force req u i red t o sepa rate or disconnect the hu midification assembly, or
one or more components of the humid ification assembly, may be at least about 20N .

[0080] A force req u i red t o sepa rate or disconnect the hu midification assembly, or
one or more components of the humid ification assembly, may be at least about 30N .

[0081 ] A force req u i red t o sepa rate or disconnect the hu midification assembly, or
one or more components of the humid ification assembly, may be about 20N t o about
200N .

[0082 ] A force req u i red t o sepa rate or disconnect the hu midification assembly, or
one or more components of the humid ification assembly, may be about 30N t o about
100N .

[0083 ] A sepa ration of one or more components of the hum id ification assembly may
ca use destruction of at least one component of the humidification assembly.
[0084] The conduit may be flexible.

[0085 ] The conduit may be at least pa rtia lly tra nspa rent.

[0086] The conduit may be formed of polyvi nyl ch loride (PVC) .

[0087 ] The conduit may have a length for creati ng sufficient pressu re t o su pply f l uid
from the f l uid reservoi r t o the humid ification cha mber.

[0088] The f l uid pressure may be insufficient t o da mage components of the


humid ification assembly, when in use.

[0089 ] The conduit may be at least 0 . 1m in length.

[0090] The conduit may be about 0 .3m t o 3m in length .

[0091 ] The conduit may be about 0 .5m t o 2m in length .

[0092 ] The conduit may be about 0 . 6m in length .

[0093 ] The conduit may be a condu it assembly, a nd may comprise of one or more
cond uits connected together.

[0094] The con nection between these one or more cond uits may be perma nent.

[0095 ] The f l uid reservoi r may be perma nently connected with a f i rst cond uit.

[0096] The humid ification chamber may be perma nently connected with a second
cond uit.

[0097 ] The f i rst a nd second condu its may be perma nently con nected together, for
exa mple by a perma nent joi nt, or by a connector such as the connector descri bed above,
thereby providi ng a perma nently connected f l uid reservoi r a nd humidification cha mber.
There may be other cond uit portions provided between the f i rst a nd second cond uit
portions, each of sa id cond uits or cond uit portions bei ng permanently con nected
together.

[0098] The f l uid reservoi r may comprise a t a pered base or floor w h ich leads t o an
outlet port or t o a f l u id outlet correspondi ng to, or associated with, a flu id reservoi r
connection poi nt.

[0099 ] The f l uid reservoi r may comprise at least one inlet port capa ble of being
sea led or closed, sa id inlet port for receiving a su pply of hum id ification flu id .
[00 100] The inlet port may be capa ble of bei ng sea led or closed by a lid or a ca p .

[00 10 1] The l id or ca p may be attached or reta ined t o the f l uid reservoi r or the inlet
port by a flexible a rm or stra p .

[00 102] The f l uid reservoi r may be cha rged or re-cha rged with sa id humidification
f l uid (e.g . f i l la ble and/or refi llable) via the inlet port.

[00 103] The f l uid reservoi r may comprise an attachment for securi ng t o or ha ngi ng
the f l uid reservoi r from a su pport.

[00 104] The attach ment may be a closed loop or an open hook.

[00 105] The attach ment may be provided as a sepa rate component pa rt, and/or may
be integ ra lly formed with the inlet port and/or the lid or ca p .

[00 106] The f l uid reservoi r may comprise at least pa rtia lly transpa rent or transl ucent
wa l ls t o ena ble visua l inspection of the humid ification f l uid level .

[00 107] The f l uid reservoi r may be a flexi ble receptacle.

[00 108] The f l uid reservoi r may have a ca pacity of about 0 . 25L t o about 5L.

[00 109] The f l uid reservoi r may have a ca pacity of about 0 . 5L t o about 2L.

[00 110] The f l uid reservoi r may have a ca pacity of about 1L .

[00 11 1] The f l uid reservoi r may comprise an index or i nd ices for i nd icati ng a
humid ification f l u id level or a flu id vol ume.

[00 11 2] The f l uid reservoi r may be a water bag .

[00 113] The f l uid reservoi r may be formed of polyvi nyl chloride (PVC) .

[00 114] The humid ification assembly may further comprise a control ler t o control a
rate of flow of a f l u id t o be received from the f l uid reservoi r, or a rate of flow of a f l uid t o
be discha rged or released from the f l uid reservoi r, or controls a rate of flow of a f l uid t o
be ad mitted t o the humid ification cha mber.

[00 115] The humid ification cha mber may com prise indices or an index or a visua l
guide for i nd icati ng f l uid level withi n sa id humidification cha mber.

[00 116] The humid ification assembly or kit may be steri le or may be provided as
steri le component pa rts of a sea led conta iner or receptacle.
[00117] The humidification assembly or kit as described above may be configured for
use or coupling or provided as part of a high flow respiratory support system or a high
flow respiratory support circuit comprising a flow source (or flow generator) and a patient
interface.

[00118] The humidification assembly or kit as described above may be configured for
use or coupling or provided as part of a respiratory support system or a respiratory
support circuit comprising a flow source (or flow generator) and a patient interface.

[00119] The patient interface may be of a sealing or a non-sealing type.

[00120] The patient interface may be one of: a nasal cannula, an oro-nasal mask, a
mouth-piece, a full-face mask, or a nasal cannula comprising of a sealing or non-sealing
nasal prong or prongs.

[00121] The respiratory support system and/or the humidification assembly or kit as
described above may comprise a dry line or a conduit for directing a source of respiratory
gas t o a humidification chamber or for provision t o a respiratory breathing circuit or
system.

[00122] The respiratory support system and/or the humidification assembly or kit as
described above may comprise an inspiratory conduit.

[00123] The respiratory support system and/or the humidification assembly or kit as
described above may comprise an expiratory conduit.

[00124] The humidification assembly or kit may be for multi-patient use.

[00125] The humidification assembly or kit may have a pre-determined period of in-
use capability.

[00126] The humidification assembly or kit may be for use for about 24 hours.

[00127] The humidification assembly or kit may be provided with an expiry period of
about 24 hours of use.

[00128] The fluid reservoir may be configured t o retain a volume or quantity of


humidification fluid.

[00129] The humidification chamber and the fluid reservoir may be provided as
separate component parts.
[00 130] The f l uid reservoi r may be configu red t o be cha rged, or re-cha rged, or is
recha rgeable, with a supply of humid ification f l uid .

[00 13 1] The con nection may be a hermetic connection .

[00 13 2] At least one, or each, of sa id esta bl ished connection (s) may be made by one
or more of:

- a ba rbed-type con nector,


- a structu ra l formation provid i ng for a physica l inter-connect,
- an interference or friction fit or push-fit,
- an adhesive,
- solvent bond i ng,
- heat sea l ing,
- a threaded connection .

[00 133] The humid ification f l uid may be a l iq uid .

[00 134] The humid ification f l uid may be l iq uid water.

[00 135] The humid ification f l uid may be water, hypotonic water, and/or d isti l led
water.

[00 136] Water conta ined in or t o be added t o the f l uid reservoi r may be su bsta ntia lly
pure, and/or may not conta in sol utes.

[00 137] Fl uid conta i ned in or t o be added t o the f l u id reservoi r may be sterile.

[00 138] Water conta ined in or t o be added t o the f l u id reservoi r may be disti l led
water.

[00 139] I n a sixth aspect there is provided a respi ratory su pport system for del iveri ng
humid ified gas t o a user or patient, comprisi ng :

a flow source,
a patient interface, and
the humid ification assembly or kit as descri bed in any of the above aspects or
features as d isclosed herei n,
wherei n the humid ification chamber is in f l u id commun ication with the flow source
a nd the patient interface.

[00 140] The patient interface may be for single-patient use.


[00 14 1] The flow source may be opera ble t o provide a gas flow of at least about 5
LPM .

[00 142] The flow source may be opera ble t o provide a gas flow of about 5LPM t o
about 150LPM .

[00 143] The flow source may be opera ble t o provide a gas flow of about 20LPM t o
about 90LPM .

[00 144] The flow source may be opera ble t o provide a gas flow of about 40LPM t o
about 70LPM .

[00 145] The respi ratory support system may be config ured for use or coupl i ng or
provided as pa rt of a high flow respi ratory support system or a hig h flow respi ratory
support c i rcuit comprisi ng a flow sou rce (or flow generator) a nd a patient interface.

[00 146] The respi ratory support system may be config ured for use or coupl i ng or
provided as pa rt of a respi ratory su pport system or a respi ratory support c i rcuit
comprisi ng a flow source (or flow generator) a nd a patient interface.

[00 147] The patient interface may be of a sea li ng or a non-sea li ng type.

[00 148] The patient interface may be one of: a nasa l ca nnu la, an oro-nasa l mask, a
mouth-piece, a ful l-face mask, or a nasa l ca nnula comprisi ng of a sea li ng or non-sea li ng
nasa l prong or prongs.

[00 149] The respiratory support system and/or the hu mid ification assembly or kit as
descri bed above may comprise an expi ratory cond uit.

[00 150] The assembly or kit may comprise a f irst assembly or f irst kit provid i ng
components for conti nued use with multi ple patients, and a second assembly or second
kit provid ing components for i nd ivid ua l use with an i nd ivid ua l patient.

[00 15 1] The f irst assembly or f irst kit may comprise the assembly or kit as descri bed
above.

[00 15 2] The f irst assembly or f irst kit may comprise :

a f l uid reservoi r,
a h um idification cha mber,
optiona lly a cond uit for providi ng of a f l uid connection between the f lu id reservoi r
a nd the humidification cha mber,
optiona lly a d ry li ne or a cond uit for di recti ng a sou rce of respi ratory gas t o a
humid ification cha mber or for provision t o a respi ratory breath ing c i rcuit or system, a nd
optiona lly an i nspi ratory cond uit.

[00 153] The second assembly or second kit may comprise:

a patient interface,
a f ilter, or an in-li ne f i lter, for connection between the patient interface a nd an
i nspi ratory cond uit of a f irst assembly or f i rst kit.
[00 154] The second assembly or second kit may comprise an expi ratory cond uit.

[00 155] Any of the aforementioned features or embodi ments or aspects may be
combi ned with one or more of the other featu res or em bod iments or aspects as descri bed
herei n.

[00 156] The term "hypotonic" f l uid used in t h is specification may i ncl ude d isti l led
water that may or may not be sterile. Hypotonic water has substa ntia lly no sa lts a nd has
an osmola rity of substa ntia lly 0 mOsm/Kg . I n contrast, sa li ne or IV f l uids (that are
isotonic) may have an osomola rity of about 300 mOsm/Kg . An exa mple of the water that
could be used t o f ill a f l uid reservoi r as descri bed herei n wou ld be known as "hypotonic
USP steri le water", however it w i ll be understood that any suita ble hu mid ifier flu id could
be used for del ivery from a f l uid reservoi r t o a hum id ification cha mber for humid ification
purposes.

[00 157] The terms 'cond uit' a nd 'tubi ng' as used in this specification a nd cla ims a re
intended t o broad ly mea n, u nless the context suggests otherwise, any member that
forms or provides a l umen for directing a flow of l iqu id or gases. For exa mple, a cond uit
or cond uit portion may be part of a humid ification device, or may be a sepa rate cond uit
attacha ble t o a humidification device t o provide a flow of f l uid or a f l uid commu nication .

[00 158] The terms "comprisi ng" and/or " includi ng" as used in this specification a nd
cla i ms mea ns "consisti ng at least in pa rt of". When interpreting each statement in this
specification and cla i ms that i ncl udes the term "comprising" and/or " i ncl ud ing", featu res
other tha n that or those prefaced by the term may a lso be present. Related terms such
as "comprise" a nd "comprises", " incl ude" a nd " i ncl udes" a re t o be interpreted in the sa me
ma nner.

[00 159] It is intended that reference t o a ra nge of nu mbers d isclosed herein (for
exa mple, 1 t o 10) a lso incorporates reference t o all rationa l num bers withi n that ra nge
(for exa mple, 1, 1. 1, 2, 3, 3 .9, 4, 5, 6, 6 .5, 7, 8, 9 a nd 10) a nd a lso any ra nge of rationa l
numbers with in that ra nge (for exa mple, 2 t o 8, 1.5 t o 5.5 a nd 3 . 1 t o 4 . 7) a nd, therefore,
all sub-ra nges of a ll ra nges expressly disclosed herei n a re hereby expressly disclosed .
These a re on ly exa mples of what is specifica lly intended a nd a ll possible combi nations of
numerica l va l ues between the lowest val ue a nd the highest va l ue en umerated a re t o be
considered t o be expressly stated in this a ppl ication in a simi la r ma nner.

[00 160] As used herei n the term "and/or" mea ns " and" or "or", or both .

[00 16 1] As used herei n "(s)" fol lowi ng a noun mea ns the p l ura l and/or s i ng ula r forms
of the nou n.

[00 162] To those skil led in the art t o which the invention relates, ma ny cha nges in
construction a nd widely differi ng embod iments a nd applications of the invention wil l
suggest themselves without depa rti ng from the scope of the invention as defi ned in the
a ppended cla i ms. The disclosures a nd the descri ptions herei n a re purely i ll ustrative a nd
a re not intended t o be in any sense limiti ng .

[00 163] The disclosure consists in the foregoing a nd also envisages constructions of
which the followi ng g ives examples on ly. Features disclosed herei n may be combi ned into
new embod iments of compati ble components add ressi ng the same or related inventive
concepts. For exa mple, connection of one i ll ustrated embodi ment may be combi ned with
f l uid conta iner or hum id ification cha mber of another illustrated embodi ment.

BRIEF DESCRIPTION OF T H E FIGURES

[00 164] Preferred embod iments of the disclosure w i ll be descri bed by way of exa mple
only and with reference t o the fol lowi ng d rawi ngs.

[00 165] Figure 1 schematica lly shows a respi ratory thera py system incorporati ng a
humidification assembly, for exa mple the humid ification assembly or kit of Figu res 2, 3 or
7.

[00 166] Figure 2 shows a perspective view of an embod iment of a humid ification
assem bly of the present disclosure.

[00 167] Figure 3 shows components of an embod iment of a humid ification assembly
of the present disclosure.

[00 168] Figures 4A and 4 B show perspective a nd front views of a con nector of an
embod iment of the present disclosure.

[00 169] Figures 5A and 5 B show perspective views of a f l uid reservoi r of an


embod iment of the present disclosure.
[00 170] Figure 6 shows a perspective view of a f l uid reservoi r of an embod iment of
the present disclosure.

[00 17 1] Figure 7 shows an em bodi ment of a hu mid ification assembly of the present
disclosure.

DETAILED DESCRIPTION

[00 17 2] Va rious embodi ments a re descri bed with reference t o the Fig ures.
Throughout the Figu res a nd specification, the sa me reference numera ls may be used t o
designate the sa me or s i mila r components, a nd red unda nt descri ptions thereof may be
omitted .

[00 173] Flypotonic water already exists in bottles in theatre for other reasons. The
invention of this disclosure provides for an a ppa ratus, system or assem bly in which this
water ca n be used t o f i ll/refil l a water bag . The water bag is t o be provided in perma nent
f l uid communication with a humidifier cha mber.

[00 174] The present disclosure is intended t o m i n i mise, reduce or a mel iorate, the risk
of provid i ng hypotonic water t o a patient, and/or directi ng an isotonic solution t o a
humid ification cha mber. With the d isclosed humidification assembly or kit, med ica l
personnel may have t o ma ke a conscious and/or intentiona l effort t o incorrectly
ad m i nister the wrong f l uid bag . This is a problem not recog nized with cu rrent f l uid (water
a nd IV) bags a nd humid ifier cha mbers/i nfusion pumps that a re used in an operati ng
theatre/room, where optiona lity in what t o con nect t o is val ued over perma nence of
connection . Moreover, incorrectly ad m i nisteri ng the wrong bag may have serious
i mpl ications for a patient, such that there exists a rea l patient and eq u i pment safety risk
in a busy and/or stressful theatre envi ron ment.

[00 175] Figu re 1 illustrates a hum id ifying respi ratory c i rcu it. A patient P is receiving
humid ified a nd pressurised gases t h roug h a nasa l ca nn ula assembly of a patient interface
601 that is operatively connected t o a hu midified gases tra nsportation pathway or
i nspi ratory cond uit 401 via a f ilter 501 . The i nspi ratory cond uit 401 in turn is connected
t o a humidifier 200 ( i ncl ud i ng h um id ifier cha mber 251) that is suppl ied with gases from a
blower 115 or other appropriate gases supply mea ns via a gases del ivery cond uit 30 1.
The gases del ivery cond uit is a 'd ry' cond uit; that is, it is positioned upstrea m of the
humid ifier. Fleadgea r 620 is provided t o support a nd reta in the patient interface aga inst
the patient's face.
[00 176] The i nspi ratory condu it 401 is connected t o the outlet 257 of the h um idifier
cha mber 25 1 which conta i ns a vol ume of l iq uid such as water. Humid ifier chamber 251
may be formed from a plastics materia l a nd may have a h ig hly heat cond uctive base 259
(for exa mple an al umi n ium base) which is in direct contact with a heater plate 203 of
humid ifier 200 .

[00 177] The humid ifier 200 is provided with control mea ns or electronic control ler
205 which may comprise a microprocessor based control ler executi ng computer softwa re
comma nds stored in associated memory. Gases flowi ng through the i nspi ratory cond uit
401 a re passed t o the patient by way of an optiona l filter 501 a nd patient interface 601 .

[00 178] The controller 205 receives input from sou rces such as user input mea ns or
d ia l 207 throug h w h ich a user of the device may, for exa mple, set a predetermined
req u i red va l ue (pre-set va l ue) of humid ity or temperature of the gases suppl ied t o patient
P. I n response t o the user set humid ity or temperature va l ue input via d ia l 207 a nd other
possi ble inputs such as interna l sensors that sense gases flow or tem perature, or by
pa rameters ca lculated in the control ler, control ler 205 determi nes when (or t o what level)
t o energ ise heater plate 203 t o heat the water withi n humidifier cha mber 251 . As the
vol ume of water withi n hu mid ifier cha mber 251 is heated, water va pour beg i ns t o f i ll the
vol ume of the cha mber a bove the water's surface a nd is passed out of the hu mid ifier
cha mber 251 outlet port 257 with the flow of gases (for exa mple air) provided from a
gases su pply mea ns or blower 115 which enters the cha mber throug h gases inlet port
255 . It shou ld be noted that it is possi ble t o obta in the relationshi p between the
humid ity of the gases in hu mid ifier cha mber 25 1 a nd the temperature of the heater plate
203 . Accord i ng ly, it is possi ble t o uti l ise the heater plate temperature in an algorithm or
a look-u p t a ble t o determi ne the humid ity of the gases.

[00 179] The blower 115 may be provided with a va ria ble speed pump or fa n 1 12
which d raws air or other gases throug h the blower inlet 117 . The speed of varia ble speed
pump or fa n 112 may be controlled by a further control mea ns or electronic control ler
118 (or alternatively the function of this control ler 118 could be ca rried out by the other
controller 205) in response t o in puts from controller 205 a nd a user set predetermi ned
req u i red va l ue (pre-set val ue) of pressu re or fan speed or flow rate via d ia l 1 19 or other
input device. Alternatively, the gases may be provided from a wa ll supply; i .e. a wa ll gas
port G P in a wa ll W.

[00 180] A housi ng 1 16 of the blower is provided with an outlet port 120. An inlet
port 303 of the gases del ivery cond uit 301 a nd the outlet port 120 of the blower a re
provided with complementa ry coupl i ng features t o connect the outlet port 120 with the
inlet port 303, and t o provide a gases flow path therethrough . The complementa ry
cou pli ng featu res may in pa rt be provided by a n ada pter insert.

[00 18 1] I n some config urations, rather tha n usi ng a blower 1 15 , gases flow may be
obta i ned from some other source(s) of gas. For exa mple, i n some config urations,
source(s) of gas may comprise one o r more conta iners of compressed a ir a nd/or a nother
gas and one o r more v a lve a rra ngements ada pted t o control the rate at which gases
leave the one o r more conta iners. As another exa mple, in some config urations, gases
may be obtai ned from a n oxygen concentrator. The system may a lso incl ude a
supplementa ry gases source t o provide a n a ir a nd supplementa ry gas mixture. For
exa mple, the su pplementa ry gas mig ht be 02. I n some config urations, the a ppa ratus
may be ada pted t o del iver a hig h flow thera py.

[00 182] " FHig h flow thera py" as used in this d isclosure may refer t o delivery of gases
t o a patient at a flow rate of g reater tha n o r eq ua l t o a bout 5 o r 10 litres per m inute ( 5 o r
10 LPM o r L/mi n) .

[00 183] I n some configu rations, ' high flow thera py' may refer t o the del ivery of gases
t o a patient at a flow rate of a bout 5 o r 10LPM t o a bout 150LPM, o r a bout 1 5LPM t o a bout
95LPM, o r a bout 20LPM t o a bout 90LPM, o r about 25LPM t o a bout 85LPM, o r a bout 30LPM
t o a bout 80LPM, o r a bout 35LPM t o a bout 75LPM, o r a bout 40LPM t o a bout 70LPM, o r
a bout 45LPM t o a bout 65LPM, o r a bout 50LPM t o a bout 60LPM . For exa mple, accord ing
t o those v a rious embodi ments a nd config urations descri bed herei n, a flow rate of gases
suppl ied o r provided t o a n interface o r via a system o r from a flow source, may comprise,
but is not li mited to, flows of at least a bout 5 , 10 , 20, 30, 40, 50, 60, 70, 80, 90, 100,
1 10, 120, 130, 140, 150 L/mi n , o r more, a nd usefu l ra nges may be selected t o be a ny of
these v a lues (for exa mple, a bout 2 0 t o a bout 9 0 LPM, a bout 4 0 t o a bout 7 0 LPM , a bout
4 0 t o a bout 8 0 LPM, about 50 t o a bout 8 0 LPM, a bout 6 0 t o a bout 8 0 LPM, a bout 7 0 t o
a bout 100 L/mi n, a bout 7 0 t o 8 0 L/mi n) .

[00 184] Gases del ivered may comprise a percentage of oxygen . I n some
configu rations, the percentage of oxygen in the gases del ivered may be a bout 20% t o
a bout 100%, o r a bout 30% t o a bout 100%, o r about 40% t o a bout 100%, o r about 50%
t o a bout 100%, o r a bout 60% t o a bout 100%, o r a bout 70% t o a bout 100%, o r a bout
80% t o a bout 100%, o r a bout 90% t o a bout 100%, o r about 100%, o r 100%.

[00 185] Hig h flow thera py has been found effective in meeti ng o r exceed ing the
patient's inspi ratory flow, t o increase oxygenation of the patient a nd/or red uce the work
of breathing . Add itiona lly, high flow therapy may generate a f lushi ng effect in the
nasopha rynx such that the a natom ica l dead space of the upper a irways is f lushed by the
hig h incoming gas flows. This creates a reservoi r of fresh gas ava i la ble of each a nd every
breath, whi le m i n i misi ng re-breathi ng of ca rbon dioxide, nitrogen, etc.

[00 186] The humid ifier 200 has a humid ifier base comprisi ng a housi ng 201 with the
heater 203, the controller 205 that is coupled t o the heater, a nd the user input device
207 t o ena ble a user t o turn on a nd off the humidifier a nd t o select a desi red temperature
t o be provided by the heater. The user input device 207 may for exa mple be a button,
switch, or touch screen display. The heater 203 may comprise one or more heati ng
elements.

[00 187] The humid ifier base is configu red t o receive the humid ifier cha mber 251 .
The hu mid ifier cha mber 251 comprises a housi ng 253 defi n i ng an interna l l iq u id reservoi r
254, an upstrea m gases inlet port 255 in f l uid/pneu matic comm unication with the l iq uid
reservoir, a downstrea m gases outlet port 257 in f l uid/pneu matic commun ication with the
l iqu id reservoi r, a nd a base 259. The base 259 is a rra nged t o be positioned on or a bove
the heater 203 t o heat l iq uid in the l iq uid reservoi r . The base may com prise a fla nge 261
that projects outwa rd ly from an adjacent portion of the housi ng 253, t o assist with
locati ng the humid ifier cha mber in position on the hu mid ifier base.

[00 188] The gases inlet port 255, the l iq uid reservoi r 254, a nd the gases outlet port
257 a re in f l uid/pneumatic communication t o provide a gases flow path from the gases
inlet port 255, through or past the l iq uid reservoi r, t o the gases outlet port 257 t o heat
a nd humid ify gases travel li ng a long the gases flow path .

[00 189] The humid ifier cha m ber 251 may be any suitable chamber that holds
suita ble l iq uid for use in humidifyi ng gases, such as water for exa mple. The humid ifier
cha mber 251 may be a ma nua l f i ll cha mber, a nd may be f i l led t h roug h a l iq uid inlet port
263 . Alternatively a nd prefera bly, the humid ifier cha mber 251 may be an automatica lly
f i lli ng cha mber, a nd liq uid may be fed t o the hum idifier cha mber from a f l uid
reservoir/l iqu id conta iner, bag, or other l iq uid source. The humid ifier chamber may
comprise a float valve in the l iq u id reservoi r, the float valve config u red t o control flow of
l iqu id form the l iq uid conta i ner i nto the l iq uid reservoir.

[00 190] A gases del ivery cond uit 301 is located upstrea m of the humid ifier cha mber
251 . The gases del ivery cond uit 301 is in flu id/pneumatic commun ication with the
humid ifier cha mber 251 or is config ured t o be placed in f l uid/pneumatic commu nication
with the humid ifier cha mber upstrea m of the humid ifier cha mber; i .e. with the hum id ifier
cha mber 251 downstrea m of the gases cond uit 301 . The gases delivery conduit 301 is
configu red t o receive one or more gases from a source of gas a nd del iver the gas(es) t o
the gases in let port 255 of the humid ifier cha m ber.
[ 00191 ] The gases del ivery cond uit 301 has an upstrea m gases inlet port 303 at one
end of the cond uit, a nd a downstrea m gases outlet port 305 at the opposite end of the
cond uit. The gases in let port 303 and the gases outlet port 305 a re in f l uid/pneu matic
communication t o provide a gases flow path from the gases inlet port 303 t h roug h the
gases del ivery cond uit t o the gases outlet port 305. The gases outlet port 305 of the
gases del ivery cond uit a nd the gases in let port 255 of the humid ifier cha mber 251 may
comprise complementa ry cou p l i ng features, t o ena ble the gases del ivery cond uit 301 t o
be coupled t o the humidifier t o provide f l uid/pneu matic commu nication between the
gases del ivery condu it 301 a nd the humid ifier cha mber 251 . The complementa ry coupl i ng
features of the gases outlet port 305 of the gases del ivery cond uit 30 1 a nd the gases
inlet port 255 of the hu midifier cha mber 25 1 may be d isconnecta ble from each other t o
ena ble the gases del ivery cond uit 251 t o be decoupled from the humid ifier cha mber 251 .
Alternatively, the complementary coupl i ng features may be perma nently or semi¬
perma nently coupled .

[ 00192 ] The gases inlet port 303 of the gases del ivery condu it may be provided with
coupli ng feature(s) t o ena ble the gases del ivery cond uit t o be coupled t o the sou rce of
gas.

[ 00193 ] An inspiratory conduit 40 1 extends from the h umid ifier cha mber 251 t o li nk
the humidifier t o a patient interface 60 1 via an optiona l in-l i ne f i lter 501 . The inspi ratory
cond uit 401 may comprise a cond uit heater 403 ada pted t o heat gases passi ng throug h
the condu it 401 . The heater 403 w i ll hel p min i mise or prevent the formation of
condensation in the i nspi ratory cond uit, which could otherwise occur d ue t o a
temperature differentia l between the interior of the cond uit wa ll a nd exterior of the
cond uit wa ll. I n other config urations the cond uit heater 403 may not be present. The
i nspi ratory condu it 401 comprises an upstrea m gases inlet port 405 at one end of the
conduit a nd a downstrea m gases outlet port 407 at the opposite end of the cond uit, with
the cond uit defini ng a gases flow path from the gases inlet port 405 t o the gases outlet
port 407 .

[ 00194 ] The humid ifier cha mber 251 is in flu id/pneumatic com munication with the
gases in let port 405 upstream of the i nspi ratory cond uit 401 or is config ured t o be placed
in f luid/pneumatic comm unication with the gases inlet port 405 upstrea m of the
i nspi ratory condu it; i .e. with the i nspi ratory cond uit positioned downstrea m of the
humidifier cha mber 251 . The gases outlet port 257 of the hu mid ifier cha mber 251 a nd
the gases inlet port 405 of the i nspi ratory cond uit 401 may comprise complementa ry
coupli ng features, t o ena ble the inspi ratory cond uit 401 t o be coupled t o the humid ifier t o
provide f l uid/pneumatic communication between the humid ifier cha mber 25 1 a nd the
inspiratory cond uit 40 1. The complementa ry coupl i ng features of the gases outlet port
257 of the humid ifier cha mber 251 a nd the gases inlet port 405 of the i nspi ratory cond uit
401 may be disconnecta ble from each other t o ena ble the i nspi ratory cond uit 401 t o be
decoupled from the hu mid ifier cha mber 25 1. Alternatively, the complementa ry coupli ng
features may be perma nently or semi-perma nently coupled .

[00 195] The i nspi ratory cond uit 401 w i ll typical ly have a longer length tha n the gases
del ivery cond uit 30 1.

[00 196] The optiona l f ilter 501 comprises a genera lly cyl i nd rica l f ilter housi ng 503
with an en la rged centra l body portion . A leadi ng edge of the enla rged centra l body
portion comprises a t a peri ng wa ll that termi nates at an upstrea m gases inlet port 505,
a nd a trai li ng edge of the en la rged centra l body portion termi nates at a downstrea m
gases outlet port 507. The gases inlet port 505 a nd gases outlet port 507 a re in
f l uid/pneu matic com munication via the centra l body portion . The f i lter may be a hig h-
efficiency pa rticulate arresta nce ( H EPA) f i lter. The en la rged centra l portion of the f i lter
housi ng conta i ns suita ble f i ltration materia l. For exa mple, the f i ltration material may
comprise pleated pa per, na no-fibers, or any other suita ble f i ltration material , i ncl ud ing
sock f i lters, stacked d isc f i lters, spi ra l filters, block(s) of f i lter materia l, a d isc or d iscs of
f i lter materia l with strea ms of f i lter materia l t o free flow from or off the disc in f l uid flow.
The filter ca ptu res a nd prevents downstrea m passage therethroug h of particulates,
bacteria and/or other infectious materia l from the i nspi ratory condu it t o the patient, and
a lso ca ptures and prevents upstrea m passage therethroug h of bacteria and/or other
infectious materia l from the patient t o the inspiratory condu it.

[00 197] The gases inlet port 505 of the f ilter 501, if present, a nd the gases outlet
port 407 of the i nspi ratory condu it 40 1 may comprise complementa ry coupl i ng features,
t o enable the inspiratory cond uit t o be coupled t o the filter t o provide fluid/pneumatic
communication between the inspiratory cond uit a nd the f i lter. The complementa ry
coupli ng featu res of the gases inlet port 505 of the f i lter, if present, a nd the gases outlet
port 407 of the i nspi ratory cond uit 401 a re disconnecta ble from each other t o ena ble the
i nspi ratory condu it 401 t o be decou pled from the f i lter 501 .

[00 198] I n one configuration, the complementa ry coupli ng features between the
gases outlet port 407 of the i nspi ratory cond uit 401 a nd the gases inlet port 505 of the
f i lter comprise a 22mm medica l con nection or 22mm med ica l t aper connection . An
electrica l connector may be provided on the gases inlet port of the i nspi ratory cond uit.
The electrical connector may provide for a power connection t o a heater wire of the
i nspi ratory condu it, or therethroug h t o any associated components with i nspi ratory
cond uit or other pa rts of the kit or assembly. The electrical connector may a lso all provide
connection t o sig na l, commu nication or sensor w i res.
[00 199] The optiona l f ilter 501 is in f l uid/pneumatic communication with the patient
interface 601 upstrea m of the patient interface or is config ured t o be placed in
f l uid/pneumatic commu nication with the patient interface 60 1 upstrea m of the patient
interface 601 ; i .e. with the patient interface located downstrea m of the f i lter. I n one
configu ration, the f i lter 501 is coupled t o the patient interface 601 or is config ured t o be
coupled t o the patient interface 601 .

[00200] The patient interface 601 comprises a patient interface gases cond uit 603
with an upstrea m gases inlet port 605 at one end of the cond uit. The opposite
downstrea m end of the patient interface gases conduit 603 is in f l uid/pneumatic
commu nication with a patient can nula 30/607 t o del iver gases from the patient interface
gases cond uit 603 t o a patient P.

[0020 1] I n one configuration, the gases outlet port 507 of the optiona l filter 501 a nd
the gases inlet port 605 of the patient interface gases cond uit comprise complementa ry
coupli ng features t o ena ble the filter 501 t o be coupled t o the patient interface 601 t o
provide f l uid/pneumatic communication between the f i lter a nd the patient interface gases
cond uit, with the f i lter in-line with a gases flow path throug h the patient interface gases
cond uit. The com plementa ry cou p l i ng features may be disconnectable from each other t o
ena ble the f i lter t o be decoupled from the patient interface gases tube of the patient
interface. Alternatively, the complementa ry coupl ing featu res may be perma nently or
semi-perma nently coupled .

[00202] I n one configuration, the complementa ry coupli ng features between the


gases outlet port 507 of the f i lter 501 a nd the gases inlet port 605 of the patient interface
601 com prise a 22mm medica l t a per con nection .

[00203] I n an alternative config uration, the patient interface 601 comprises a patient
interface gases cond uit 603, a nd the f i lter 501 is i nteg ra lly formed with the patient
interface gases cond uit t o provide f l uid/pneumatic communication between the f i lter 501
a nd the patient interface gases cond uit 603, with the filter i n-l i ne with a gases flow path
throug h the patient interface gases conduit. That is, the f ilter a nd patient interface may
be an i nteg rated unit.

[00204] I n another exa mple embod iment without a f i lter, the gases outlet port 407 of
the i nspi ratory condu it 401 con nects t o the gases inlet port 605 of the patient interface
gases cond uit 603. The gases outlet port 407 of the inspi ratory cond uit 401 a nd the
gases in let port 605 of the patient interface gases conduit 603 may comprise
complementa ry coupl i ng features, t o ena ble the inspiratory cond uit t o be coupled t o the
patient interface cond uit t o provide fluid/pneumatic com munication between the
inspi ratory conduit a nd the patient interface cond uit. The complementa ry coupl i ng
features of the gases outlet port 407 of the inspiratory cond uit a nd the gases inlet port
605 of the patient interface gases cond uit 603 a re disconnecta ble from each other t o
ena ble the i nspi ratory condu it 401 t o be decoupled from the patient interface.

[00205] I n one configuration, the complementa ry coupli ng features between the


gases outlet port 407 of the i nspi ratory cond uit 401 a nd the gases inlet port 605 of the
patient interface gases cond uit 603 comprise a 22mm med ica l connection or 22mm
medica l t aper connection .

[00206] The patient interface 601 is shown t o be a nasa l ca nnula, althoug h it should
be understood that in some config urations, other patient interfaces may be suita ble. For
exa mple, in some config urations, the patient interface may comprise a sea li ng or non¬
sea li ng interface, a nd may comprise a nasa l mask, an ora l mask, an oro-nasa l mask, a
f u ll face mask, a nasa l p i llows mask, a nasa l ca nnula, an endotrachea l tube, a
tracheostomy tube, a combi nation of the above or some other gas conveyi ng system . I n
an embodi ment, the patient interface 601 comprises a non-sea li ng interface such as a
nasa l ca nnula, w h ich al lows gases t o be exchanged with the envi ronment. For exa mple,
the non-sea li ng ca nnula al lows ca rbon dioxide t o be removed and/or clea red from the
patient's airways whi le the patient receives flow thera py from the system . Further, in an
em bodi ment, the patient interface is in the form of a nasa l interface, such that the
system does not interfere with other ora l airway eq u i pment and/or devices, for exa mple,
a tracheal tube in an intu bation proced ure. Accordi ng ly, the patient may contin ue t o
receive flow thera py throug hout the intubation proced u re.

[00207] The patient interface gases cond uit 603 forms a f i rst gas lumen defi ned by a
tubula r wa ll. The first gas lumen is ada pted t o receive gases from the respi ratory thera py
system, via the i nspi ratory cond uit 401 a nd f i lter 50 1 shown in Fig ure 1, a nd cha nnel the
gases t o the patient P.

[00208] The i ll ustrated f i rst gas lumen is defi ned at least in pa rt by a wa ll withi n
which gases ca n be cha nnel led .

[00209] The f i rst gas lumen may optiona lly comprise a rei nforcement element
ada pted t o strengthen and/or add rig id ity t o the f i rst gas lu men t o prevent deformation
or col la pse of the f i rst gas lu men arisi ng d ue t o the application of forces aga inst the f i rst
gas lumen . The rei nforcement element may include a nu mber of structures, i ncl ud i ng but
not li mited t o plastic or meta ll ic rei nforcing beads that l ie in or on the wa ll of the first gas
lumen . Alternatively, the lu men may, in some config urations, com prise wea kened
sections, or sections w h ich a re una ble t o self-ma inta in thei r flow path or a f l uid flow
passage, t o allow for a mask t o sea l over the patient interface, such as a nasa l ca nnula or
nasa l mask, a nd t o reduce or prevent the flow of gases t o the patient interface.
[00210] The f i rst gas lu men 603 is in f l uid/pneu matic commun ication with a flow
ma nifold . The flow ma nifold receives gases from the f irst gas lu men 603 a nd passes them
t o one or more nasa l del ivery elements (e.g . the nasa l prongs of a nasa l ca nnula, not
shown) . The one or more nasa l del ivery elements extend outwa rd ly from the flow
ma nifold . The one or more nasa l delivery elements a re ada pted t o be non-sea l ing ly
positioned in one or more nares of the patient P.

[0021 1] As shown, in one exa mple, the patient interface 60 1 ca n comprise two nasa l
del ivery elements ada pted t o be positioned one in each of the patient's nares. Each nasa l
del ivery element may be sha ped or a ng led such that it extends inwa rdly towa rds a
septum of the patient's nose.

[0021 2] Additiona lly, each nasal del ivery element may be sha ped or angled such that
a t ip of each nasa l del ivery element points, in use, towa rds a back of the head of the
patient P. I n the embodi ment shown in fig ure 1, the flow man ifold receives flow from one
latera l side of the flow ma nifold (e.g . with respect t o an i mag i na ry vertical pla ne bisecti ng
the face of the patient P) a nd cha nnels flow t o each of the nasa l del ivery elements. I n
other configu rations, the patient interface 60 1 may comprise greater (for exa mple, three
or fou r) or fewer (for exa mple, one) nasa l del ivery element.

[00213] I n other config urations, each nasa l del ivery elements ca n have different
properties. For example, one of a pai r of nasa l del ivery elements ca n be relatively long
a nd the other nasal del ivery element can be relatively short. I n some config urations, the
flow manifold may be configured t o receive flow from two latera l sides of the flow
ma nifold (e.g . from a 'left' a nd 'rig ht' of the flow ma nifold when instead of j ust the 'left' of
the flow ma nifold as seen in Figure 1) . I n some such configu rations, mu ltiple gas lu mens
may be used t o provide for pneumatic communication between the flow ma nifold a nd the
respi ratory thera py system . I n some configu rations, the flow ma nifold may be config ured
t o receive flow from a non-latera l side of the flow ma nifold (e.g . from a 'bottom' or 'top'
of the flow man ifold) .

[00214] I n other config urations, as noted, the ma nifold may be a sepa rately
attacha ble component t o be attached t o the body of the interface, such as a nasa l
ca nnula or nasa l mask. Such a ma nifold may be an enti rely sepa rate component able t o
be removed from attachment t o the interface, or it may be de-attached or disconnected
from an operational position t o a l low for a re-orientation of the ma nifold (a nd associated
supply condu it) relative t o the interface. For exa mple, the ma nifold may be of a push-fit
type a rra ngement t o be push-fitted into a connection with the interface body, or may be
of a swivel-type con nection with the body of the interface allowi ng for a re-orientation of
the ma nifold . A re-orientation allows for the supply cond uit t o be positioned t o a left or a
rig ht side of the interface (a nd therefore cha nged from one side t o another of the
patient) . This may al low for an improved convenience or arra ngement of components in a
system deliveri ng gas t o the patient. For exa mple, if those assisti ng in a med ica l
proced ure need access t o the patient from one pa rticu la r side, then the ma nifold ca n be
re-oriented a nd the su pply tube re-positioned so as t o extend from a different side of the
patient. Such an arrangement al lows for a relatively unobtrusive a ppl ication of a patient
interface a nd its associated components away from medica l specia l ists.

[00215] The patient interface when in the form of a nasa l ca nnula may uti l ise a
headgea r in the form of a strap that ca n be bifu rcated ( i .e. a li ne of wea kness or other
split arra ngement ca n be config ured) t o al low for the headgea r or a stra p thereof t o be
reconfig ured from a s i ng le stra p a rra ngement into a bifurcated strap a rra ngement.

[00216] The patient interface when in the form of a nasa l ca n nula may uti l ise a pa ir
of side a rms extend ing from the ma in body (to which the ma nifold is t o be put into
connection with) . The side a rms may comprise of features allowi ng for the retention or
secu rement or position ing of a gas su pply tube t o the side a rm (to prevent the gas supply
tube from uncontrol la bly movi ng about) .

[00217] The patient interface 601 may further comprise mounts and/or supports,
e.g ., cheek su pports, for attachi ng and/or su pporti ng the gas l umen 603 and/or ca nnula
30/607 on the patient's face. For exa mple, a releasable connection system may be
uti l ised t o position or locate the interface upon the patent's face, yet al low for a relatively
ra pid remova l or re-positioni ng of the interface if necessa ry.

[00218] The patient interface gases cond uit or gas l umen may be a short section of
tube or condu it. For exa mple, the patient interface gases conduit or gas lu men may be
about 20 cm t o about 50 cm long, or about 25 cm t o about 40 cm long, or about 30 cm
t o about 35 cm long, or may be about 32 cm long .

[00219] Figu res 2 a nd 3 illustrate exa mple embodi ments of a hu midification assembly
or kit 1 for use in a respiratory su pport system such as that shown in fig ure 1. The
humid ification assembly or kit 1 may del iver humid ified gases t o a user or patient via the
respi ratory support system as illustrated in figu re 1, a nd ca n include a flu id reservoi r 2
for provid i ng a source of humid ification f l u id, a humidification cha mber 3 (such as
humid ifier cha mber 251 in fig ure 1) for receivi ng a source of hu midification f l uid, a nd a
connection t o tra nsfer the humid ification flu id from the flu id reservoi r 2 t o the
humidification cha mber 3 .

[00220] The f l uid reservoi r 2 and the humid ification chamber 3 a re in f l uid con nection
or commu nication with each other, with a con nection establ ished between each of the
f l uid reservoi r 2 a nd the humid ification cha mber 3 t o provide humid ification f l uid via the
f l uid communication . The f l u id reservoi r 2 a nd the hum id ification cha mber 3 may be in
f l uid connection or commu nication even when the humid ification assembly or kit 1 is not
provid ing humidified gases t o a user or patient. The f l uid connection, f l u id communication
or f l uid pathway may be provided by a device such as a cond uit 4, tubi ng, or other form
of f l uid con nection or communication . One end of the device may be connected t o the
f l uid reservoi r 2, a nd another end may be connected t o the humid ification cha mber 3 .
Alternatively, in other embod iments there may be a direct connection esta blished
between a f l uid reservoi r a nd a hu mid ification cha m ber.

[0022 1] The con nection may be a perma nent connection. The connection may have a
pre-determi ned force of retention or resista nce t o disconnection . The connection may be
provided with a force of retention or resistance t o disconnection such that when the
connection is disconnected, it is destructively severed, for exa m ple upon a ppl ication of a
disconnection force above a pre-determi ned force of retention .

[0022 2] Additiona lly, a pa rt or component of the humid ification assem bly or kit 1
may be destroyed or da maged when the esta bl ished perma nent connection is subject t o a
disconnection force above a pre-determi ned force of retention .

[00223] The con nection between each of the f l uid reservoi r 2 a nd the hu mid ification
cha mber 3, may be a one-time, or non-reusa ble con nection, or may be an end uri ng
connection . Alternatively, the connection or f l uid communication may be esta bl ished as a
one-ti me, secured, resil ient, or a resista nt (to d iscon nection) or an endu r i ng connection
t o provide a f l uid pathway or f l u id connection between the f l uid reservoir 2 a nd the
humid ification cha mber 3 that ca nnot be reused or easi ly disconnected .

[00224] Turni ng back t o Fig ures 2 a nd 3, the pre-determi ned force of retention
and/or resista nce t o disconnection of these exa mple humid ification assembl ies may be a
force of retention provided between the cond uit 4 a nd the humid ification cha mber 3,
and/or the condu it 4 a nd the f l uid reservoi r 2 .

[00225] Alternatively, the connection provided by the condu it 4 between the flu id
reservoir 2 a nd hu mid ification cha mber 3, may be effectively perma nent, such that
remova l in the norma l scheme of use would be difficu lt, and/or would result in
deformation or da mage of one of the components of the assembly.

[00226] As outl i ned above, the establ ished connection may be config u red such that, a
cond uit 4 providi ng for the f l uid com munication is resista nt to, or una ble t o be
disconnected, or where disconnection results in da mage t o the f l uid communication .
Sepa ration or disconnection of the esta blished con nection may serve t o destructively
sever the connection, or separation or disconnection of the established connection may
be destructive of one or more components or parts which formed the established
connection. Separation or disconnection of the connection may serve t o prevent a
subsequent re-establishment of a connection.

[00227] The connection between the conduit 4 and humidification chamber 3, and/or
the conduit 4 and the fluid reservoir 2, may be made by one or more of:

- a barbed-type connector,
- a structural formation providing for a physical inter-connect,
- an interference or friction fit or push-fit,
- an adhesive,
- solvent bonding,
- heat sealing,
- threaded connection,
- any combination of the above.

[00228] Figures 4A and 4 B show an example embodiment of such a connector 5,


which may be used t o connect the conduit 4 and fluid reservoir 2 or humidification
chamber 3 of Figures 2 and 3 . The connector 5 in Figures 4A and 4 B utilises a barb type-
connection, but it should be apparent that any other suitable connector may be used t o
provide a one-time connection capability.

[00229] The connector 5 in Figures 4A and 4 B may be a fluid reservoir connector 5,


disposed at a fluid reservoir end of a conduit 4, and configured t o connect t o a fluid outlet
of a fluid reservoir.

[00230] Additionally, the connector 5 in Figures 4A and 4 B may be a humidification


chamber connector 5, disposed at a humidification chamber end of a conduit 4, and
configured t o connect t o a fluid inlet of a humidification chamber 3 . Alternatively, the
conduit 4 may be adhered, e.g. glued into connection with the humidification chamber 3 .

[00231] Therefore, in an example embodiment a conduit 4 may comprise a fluid


reservoir connector 5 at a fluid reservoir end of the conduit 4, and/or a humidification
chamber connector 5 at a humidification chamber end of the conduit 4 . One or both of
these connections may be the abovementioned connection, configured t o be permanent,
and/or resistant t o disconnection.

[00232] Any of the abovementioned connections may be hermetic connections. I n an


example, this provides a hermetic connection between the humidification chamber 3 and
the fluid reservoir 2, via the conduit 4 .
[00233] To achieve the perma nent, one-ti me, or end uri ng connection descri bed
above, the connector 5 of Fig ures 4A a nd 4B, representi ng any of the abovementioned
connections, may comprise a lead-in portion 6 substa ntia lly at or toward one end of sa id
connector 5 . The lead-i n portion 6 may faci litate the connection, and may be a t a pered
reg ion, sha ped so as t o facil itate the esta bl ish ment of con nection .

[00234] The t a pered region may be t a pered t o provide for a relatively na rrowed neck
of a relatively sma ller d ia meter, which may allow recei pt of a cond uit 4, or al low the
connector 5 t o be received by the f l uid reservoi r 2 or the humid ification chamber 3 3 . The
t a pered reg ion may faci litate ease of connection, by g uid i ng the connector 5 into the fluid
reservoi r 2 or h um idification chamber 3, or the cond uit 4 onto the con nector 5 .

[00235] The con nector 5 may be substa ntia lly flexi ble or su bsta ntia lly conformable or
non-rig id, which could alleviate stress on the connection formed by this connector 5.
Alternatively, the con nector 5 may be substa ntia lly inflexible or su bsta ntia lly non-
conforma ble or substa ntia lly rig id, which may faci litate ease of esta bl ish ment of the
connection .

[00236] Alternatively, the connector 5 may comprise both substa ntia l ly conforma ble,
a nd substa ntia lly non-conforma ble parts, w h ich may i ncl ude soft or flexible parts a long
with ha rd or rigid pa rts, or a h i nge reg ion .

[00237] The con nector 5 may be formed of polypropylene, or s i l icon, or any other
suita ble ha rder or softer materia l t o faci litate the desi red perma nent connecta b i lity.

[00238] I n an exa mple em bodi ment, the con nector 5 may be a f l uid reservoi r
connector 5, a nd may be a su bsta ntia lly long itud i na l component comprisi ng a f i rst end 8
configu red t o be received by the f l uid reservoi r, a nd a second end 9 configu red t o be
received by the cond uit 4 . A lead-i n portion 6 may be d isposed at or towa rd the f i rst end
8, a nd a rad ia lly outwa rd portion 7, for exa mple a ba rb-type a rra ngement or portion,
may be d isposed at or towa rd the second end 9 .

[00239] The radial ly outwa rd portion 7, may be config ured t o reta in the cond uit 4
once a connection is esta bl ished . The portion 7 may be rad ia lly or a nn ula rly conti nuous,
or may be rad ia lly or a nn ula rly disconti n uous.

[00240] The con nection may additiona lly comprise at least one rad ia lly outwa rd
projection 10, which may extend from an outer su rface of the f l uid reservoi r connector 5 .
The rad ia lly outwa rd projection 10 may be located intermed iate of the lead-i n portion 6
a nd the second end 9, a nd may comprises of a ba rb-type a rra ngement, config ured t o
reta in a fluid reservoi r once the connection is esta bl ished . A leadi ng edge or lead ing
surface of the radia lly outwa rd projection 10 may be lead i ng with respect t o an edge or
surface of the projection(s) which is/are t o preferentia lly ma ke contact with sa id f l uid
reservoir. The at least one rad ial ly outwa rd projection 10 may be rad ia lly conti n uous, or
radia lly disconti nuous. There may be severa l rad ia lly outwa rd projections 10 located
intermed iate the lead-i n portion 6 a nd the second end 9, t o provide add itiona l security of
retention of a con nection .

[0024 1] The con nector 5 may f urther comprise a col la r 11, w h ich may be located
intermed iate of the rad ia lly outwa rd projection 10 a nd the second end 9 . The col la r 11
ca n provide for at least two seati ng su rfaces 12, a f irst of sa id seati ng surfaces 12
provided t o substa ntial ly face towa rd the f i rst end 8 a nd a second of sa id seati ng surfaces
12 provided t o substantia lly face towa rd the second end 9 . Each seati ng surface may be
provided as a conti nuous or disconti n uous su rface.

[00242] The col la r 11 may be an annula r col la r 1 1, where the col lar 11 extends
radial ly outwa rd ly from the outer surface of the flu id reservoi r connector 5 . The col lar 11
may be dimensioned t o have a long itud inal thickness config ured t o sepa rate a termi nal
end of the condu it 4 from a f l uid reservoi r connection poi nt. The colla r 11 may be a
sepa rate component pa rt of the connector 5, or may be a thickened band reg ion of the
connector 5 .

[00243] The at least one rad ia lly outwa rd projection 10 may extend outwa rd ly of the
outer su rface t o a substa ntia lly lesser extent or d ia meter tha n the col la r 11. Col la r 11
may therefore provide a seati ng surface for a correspond i ng pa rt of a f l uid reservoi r .
S i mila rly, the rad ia lly outwa rd portion 7 of the connector 5 may extend outwa rd ly t o a
lesser extent tha n the col la r 11. Col lar 11 may therefore a lso provide a seati ng surface
for the condu it end . Alternatively, rad ia lly outwa rd projection 10 a nd portion 7 may
provide engagement featu res, optiona lly t o correspond i ng engagement features of a f l uid
reservoir and/or a cond uit. Col la r 11 may have greater diameter tha n rad ia lly outward
projection 10 a nd portion 7, a nd may therefore provide seati ng surfaces t o correspond i ng
features of a f l uid reservoir and/or a cond uit.

[00244] The radia lly outwa rd portion 7 may be located substa ntia lly at or towa rds the
second end 9, a nd may be located intermed iate of the col la r 11 a nd the second end 9,
provid ing for secure retention of a cond uit 4 .

[00245] The externa l d ia meter of the connector 5 between the second end 9 a nd the
colla r 11 may comprise two different long itud i na l length d ia meters 13A, 13B. The f i rst
long itud i nal d ia meter 13A may be substa ntia lly sma ller tha n the second long itud i na l
d ia meter 13B, a nd the f i rst d ia meter 13A may be at the second end 9, whereas the
second dia meter 13B may be long itud i na lly displaced from the second end 9 a nd more
towa rd the col la r 11. The f i rst long itud i na l d ia meter 13A may assist in provid i ng and/or
improvi ng the permanent coupl i ng a nd connection between a condu it a nd the connector
5, e.g . via i ncreasi ng ad hesion between contact surfaces, components or pa rts. The
second long itud inal d ia meter 13B may, alongside the rad ia lly outwa rd portion 7, or as a
replacement t o the rad ial ly outwa rd portion 7, provide for a friction fit t o provide secure
retention of a condu it 4 . I n t h is config uration, the radial ly outwa rd portion 7 may be
located withi n a reg ion of the f i rst longitud i na l length dia meter 13A. I n alternative
embod iments, rad ia l ly outwa rd portion 7 may be located withi n a reg ion of the second
long itudi na l dia meter 13B. I n some embod iments, there may be severa l rad ia lly outwa rd
portions 7 located withi n both regions 13A a nd 13B, providi ng add itiona l security of
retention of a con nection .

[00246] The con nector 5 of Figu res 4A a nd 4 B may comprise a lumen 14 or


passageway for enabl i ng f l uid communication between the f i rst end 8 and the second end
9, t h us provid i ng for a flu id connector 5 for use at a f l uid reservoi r and/or humidification
cha mber end of a cond uit 4 .

[00247] The force requ ired t o overcome the pre-determi ned force of retention
outl i ned above, in order t o separate the flu id reservoi r connector 5 and/or the
humid ification cha mber connector 5 a nd the cond uit 4 may be at least about 20N , or
about 30N, or may be between about 20N t o about 110N, or about 30N t o about 100N .

[00248] S i m i la rly, the force req u i red t o separate the f l u id reservoi r connector 5 a nd
the f l uid reservoi r 2 may be at least about 20N, or about 30N, or may be between about
20N t o about 200N, or about 20N t o about 1 10N , or about 30N t o about 100N . I n some
embod iments, the force req u i red t o sepa rate the f l uid reservoi r con nector 5 a nd f l uid
reservoir 2 is up t o about 200N .

[00249] S i m i la rly, the force req u i red t o sepa rate the cond uit 4 a nd the humidification
cha mber 3 may be at least about 20N, or about 30N , or may be between about 20N t o
about 1 10N, or about 30N t o about 100N .

[00250] Genera lly, the force req uired t o sepa rate or disconnect the humidification
assem bly or kit, or t o separate or disconnect one or more components of the
humid ification assembly, wou ld be more, prefera bly substa ntia lly more, tha n the forces
experienced du r i ng norma l use (for exa mple forces experienced d uri ng norma l use cou ld
be 20N or less) . The force requi red t o sepa rate or disconnect the hu mid ification assembly
or kit, or t o sepa rate or disconnect one or more components of the humid ification
assem bly, may be at least about 20N , or at least about 30N, or may be between about
20N t o about 1 ION, or about 30N t o about 100N . Sepa ration of any or a ll connections of
the humid ification assembly or kit may be ach ieved only upon the a ppl ication of a force,
a long one or more axes of engagement of the connection, havi ng a mag nitude w h ich
exceeds the forces experienced d uri ng norma l use of the assembly or kit by a mag nitude
of at least 100%, at least 200%, at least 300%, at least 400%, at least 500%, at least
600%, at least 700%, at least 800%, at least 900%, at least 1000%, or at least 1100%.
I n some embod iments, the mag nitude of force experienced t o separate or d iscon nect one
or more components of the assembly or kit may be up t o 2000% of the forces
experienced du r i ng norma l use of the assem bly or kit. It w i ll be understood that a pre¬
determ i ned force of retention as outli ned above, could be any suita ble force for resisti ng
disconnection of the hu midification assembly or kit. A sepa rati ng or disconnection force
equa l t o or more tha n t h is pre-determi ned force of retention would be req u i red t o
sepa rate the components of the humid ification assembly or kit. I n certa in embod iments,
a sepa rati ng or disconnection force more tha n this pre-determi ned force of retention
would be req u i red t o sepa rate the components of the hu mid ification assembly or kit.

[0025 1] Any sepa ration of one or more components of the humid ification assembly or
kit ca n ca use destruction of at least one component of the assembly or kit. For exa mple,
a sepa ration or disconnection of the esta blished con nection may serve t o destructively
sever the connection . This may i ncl ude da mage or destruction t o the condu it 4, the
connector 5 between the flu id reservoi r 2 a nd the cond uit 4, and/or the connector 5
between the humid ification cha mber 3 a nd the cond uit 4, and/or connection poi nts on the
f l uid reservoi r 2 or humid ification cha mber 3 . Add itiona lly, a sepa ration or disconnection
of an esta bl ished connection of the humid ification assembly may serve t o prevent or
preclude a subseq uent re-establ ishment of a connection . Put another way, any of the
abovementioned connections may be of a one-time connection ca pa b i lity.

[0025 2] The conduit 4 form ing the f l uid con nection or communication between the
f l uid reservoi r 2 and the humidification cha m ber 3 may be flexi ble, a nd may be at least
partia lly tra nspa rent. The cond uit 4 may be formed of polyvi nyl ch loride (PVC), or any
other su ita ble materia l t o provide a flexi ble or semi-flexi ble flu id connection .
Alternatively, the f l uid con nection may be rig id, a nd may be opaq ue.

[00253] I n an exa mple em bod iment, the cond uit 4 has a length that is sufficient for
creati ng sufficient pressure t o supply f l uid from the f l uid reservoi r 2 t o the humid ification
cha mber 3 . However, the f l uid pressu re may be insufficient t o da mage components of the
humid ification assembly, when in use.

[00254] The conduit 4 may be at least 0 . 1m in length, however it could be between


about 0 . 3m t o 3m in length, or about 0 . 5m t o 2m in length . I n an exa mple embod iment,
the cond uit 4 length is about 0 .6m, which may provide the abovementioned sufficient
pressu re t o su pply f l uid from the f l uid reservoi r 2 t o the hu mid ification cha mber 3,
without ca usi ng com ponent da mage due t o excess f l uid pressure. However, it w i ll be
understood that the effects of cond uit 4 or tubing length, d ia meter, a nd materia l w i ll va ry
the requi red cond uit length a nd supply pressure accord i ng ly. The supply pressu re may
a lso be affected by the f l uid reservoi r, i ncl ud i ng the f l uid reservoir outlet, a nd the
humid ification cham ber a nd its components.

[00255] The device or cond uit 4 con necti ng the f l u id reservoi r 2 a nd the
humid ification cha mber 3 may be formed as a cond uit assembly, a nd may com prise one
or more cond uits connected together. The con nection between these one or more
conduits may be perma nent. For exam ple, the f l uid reservoi r 2 may be perma nently
connected with a f i rst cond uit 4, a nd the humid ification cha mber 3 may be perma nently
connected with a second cond uit 4 . The f i rst a nd second cond uits may be perma nently
connected together, for exa mple by a perma nent joint, or by a connector such as
connector 5, thereby providi ng a perma nently connected f l uid reservoi r 2 a nd
humid ification cha mber 3 . It w i ll be understood that any suita ble number or config uration
of f l uid con nection or commu nication devices, such as cond uit 4, could be provided in
perma nent connection with each other t o achieve a con nection between a f l u id reservoi r
a nd humid ification cha mber that is secured as descri bed herein . I n some em bod iments,
there may be other condu it portions provided between the first and second cond uit
portions, each of sa id cond uits or cond uit portions bei ng perma nently connected
together.

[00256] Figu res 5A a nd 5B show an exa mple embod iment of a f l uid reservoi r 2 as
descri bed a bove. The f l uid reservoi r 2 may comprise a t a pered base 15 or floor, w h ich
may lead t o an outlet port or t o a f l uid outlet 16 correspond ing to, or associated with, a
f l uid reservoi r connection poi nt. The outlet port or f l uid outlet 16 may be config ured t o
receive the connector 5 of Fig ures 4A a nd 4 B as descri bed above, and/or may be
configu red t o d i rectly receive a cond uit 4 .

[00257] The f l uid reservoi r 2 may comprise at least one inlet port 17, w h ich may
ca pa ble of bei ng sea led or closed . The inlet port 17 may be config ured t o receive a supply
of h umid ification f l uid, a nd the f l uid reservoi r 2 may be cha rged or re-cha rged with sa id
humidification f l u id (e.g . f i l la ble and/or refi l ia ble) via the inlet port 17.

[00258] The inlet port 17 may be ca pa ble of being sea led or closed by a l id or a ca p
18. The lid or cap 18 may be attached or reta i ned t o the f l uid reservoi r 2, and/or the inlet
port 17, by a flexi ble a rm or stra p 19 .

[00259] The f l uid reservoi r 2 may comprise an attachment 20 for securi ng t o or


ha ng i ng the f l uid reservoi r 2 from a support. The attachment 20 could be a closed loop,
as illustrated in Figures 5A and 5B, or an open hook (not shown), or any other suita ble
attachment poi nt, such as throug h holes 2 1 in Fig u res 5A a nd 5B.

[00260] The attachment 20 may be provided as a sepa rate component pa rt, or may
be integ ra lly formed with the in let port 17 and/or the l id or cap 18 ( not shown) . The
attachment 20 may a lso be formed as an integra l pa rt of the f l uid reservoir 2, as shown
in Figures 5A a nd 5B. Alternatively, the attach ment 20 may be an integ ra lly formed pa rt
of the f l uid reservoi r 2 structure, or may form a part of the inlet 17 and/or lid/ca p 18
structure, or may be provided as a sepa rate ha nger portion, which ca n be attached t o the
f luid reservoi r 2 t o provide another faci lity for hangi ng the f l uid reservoir from a support.

[0026 1] The f l uid reservoi r 2 may comprise at least pa rtia lly tra nspa rent or
tra nsl ucent wa lls, or a tra nspa rent section, t o ena ble visua l inspection of the
humidification f l uid level . The f luid reservoi r 2 may comprise an index or i nd ices 22 for
i nd icating a humid ification f lu id level or a f l uid volume conta i ned withi n the f l uid reservoi r
2 . Add itiona lly, the humid ification cha mber 3 as descri bed herei n may also, or
alternatively, comprise i nd ices or an index or a visual guide for indicati ng f l uid level
withi n the humid ification cha mber 3 . The indices could a lso be formed on the cond uit 4 .

[00262] The f l uid reservoi r 2 may be a flexible receptacle (for exa mple, the flexi ble
receptacle may be a bag, such as a water bag) . Alternatively, the f lu id reservoi r 2 may
comprise a rigid or semi -rig id contai ner. I n either case, the f l uid reservoi r 2 may be
formed of a plastic, or other su itable materia l for conta i n i ng f luid, for exa mple polyvi nyl
chloride ( PVC) .

[00263] The f l uid reservoi r 2 is config ured t o reta in a vol u me or q ua ntity of


humid ification f lu id, a nd may have a ca pacity of about 0 . 25L t o about 5L, or about 0 . 5L
t o about 2L. I n an exam ple em bodi ment, the ca pacity of the f l uid reservoi r 2 is about 1L .

[00264] Figu re 6 i ll ustrates an exa mple of a f l uid reservoi r 2 suita ble for use with the
humid ification assem bly or kit as descri bed herei n. This f l uid reservoi r 2 i ncl udes a sing le
attachment poi nt 20 integ rated into the f l uid reservoi r 2, and an off-centre inlet port 17
for f i ll ing and refil li ng the f l uid reservoir 2 . Alternatively, the in let port 17 could be
provided in the centre of the f lu id reservoi r 2, for exa mple taki ng the place of attachment
poi nt 20 . An attach ment poi nt cou ld be provided as an integ ra l pa rt of such a centra l inlet
port, or one or more attachment poi nt(s) could be provided at either side of such a
centra l inlet port, optiona lly these attachment point(s) cou ld be throug h holes integra lly
formed as pa rt of the f l uid reservoi r .

[00265] The humid ification assembly or kit 1 as descri bed above may include a
controller t o control a rate of flow of hum id ification flu id t o be received from the flu id
reservoir 2, t o the hu mid ification cha mber 3 . The control ler may be used t o control a rate
of flow of flu id t o be d ischa rged and/or released from the f l u id reservoi r 2, or t o control a
rate of flow of f l uid t o be del ivered and/or ad mitted t o the humid ification cha mber 3 . The
controller may be an integ ra l pa rt of the cond uit 4, f l uid reservoi r 2, and/or
humid ification cha m ber 3, or may be a sepa rate component.

[00266] Figu re 7 shows an exa mple embodi ment of a humid ification assembly or kit 1
as descri bed herei n, comprisi ng f l uid reservoi r 2, h um idification chamber 3, a nd condu it
4 . The f l uid reservoir 2 i ncl udes t a pered base 15 a nd f l uid outlet 16, a long with inlet port
17 comprising a l id 18, stra p 19, a nd attachment 20 . I n this exa mple embod iment,
connector 5 is shown providi ng a one-ti me and/or perma nent connection between conduit
4 a nd f l uid reservoi r 2 . The other end of cond uit 4 is perma nently attached t o
humid ification cha mber 3 by an adhesive or friction fit. Humidification chamber 3 a lso
i ncl udes gases inlet 23, for connection t o a d ry l ine or other source of un-hu midified
breathi ng gases, a nd gases outlet 24, for connection t o an i nspi ratory cond uit for
tra nsmission of humid ified breath ing gases t o a patient. Gases inlet 23 a nd gases outlet
24 may be eq uiva lent t o gases inlet port 255 a nd outlet 257 as shown in Fig ure 1.

[00267] The humid ification assembly or kit may be steri le, or at least provided as
steri le component pa rts of a sea led conta iner or receptacle. For exa mple, the
humid ification assembly or kit may be provided for use in a surgery or theatre situation,
a nd provided with an anaesthesia kit in a sea led receptacle t o be opened a nd used for
patient humid ification d uri ng a procedu re.

[00268] The humid ification assembly or kit may be config ured for use or cou pli ng or
provided as pa rt of a respi ratory support system, or a respi ratory support c i rcuit
comprisi ng a flow source (or flow generator) a nd a patient interface (such as a can nula) .
The respi ratory support system could be a hig h flow system .

[00269] The patient interface cou ld be of a sea li ng or a non-sea li ng type, a nd could


be one of a nasal ca nn ula, an oro-nasa l mask, a mouth-piece, a ful l-face mask, or a nasa l
ca nnula comprisi ng of a sea li ng or non-sea li ng nasa l prong or prongs.

[00270] The respiratory support system and/or the hu mid ification assembly or kit
may also i ncl ude a d ry li ne or a gases condu it for di recti ng a source of respi ratory gas t o
a h um id ification cha mber 3, or for provision t o a respi ratory breathi ng c i rcuit or system .

[0027 1] The respiratory support system and/or the hu mid ification assembly or kit
may a lso i ncl ude an i nspi ratory cond uit, and/or an expi ratory cond uit.
[0027 2] The humid ification assembly or kit may be desig ned for mu lti-patient use,
a nd may have a pre-determi ned period of in-use ca pa b i lity, for exa mple, the
humid ification assembly or kit may have a use lifeti me of about 24 hours, and may be
provided with an expiry period of about 24 hours of use.

[00273] The respiratory support system may comprise a first assembly or first kit
provid ing components for conti nued use with multiple patients, a nd a second assembly or
second kit providi ng com ponents for i nd ivid ua l use with an individ ua l patient.

[00274] The f i rst kit may comprise the hu mid ification assembly or kit 1 as descri bed
herei n, i ncl ud i ng a f l uid reservoi r 2, a humid ification cha mber 3, a cond uit 4 for provid i ng
of a f l uid pathway or f l uid connection between the f l uid reservoi r 2 and the humid ification
cha mber 3, optiona lly a dry li ne or a gases cond uit for di recti ng a source of respiratory
gas t o a humidification cha mber 3 or for provision t o a respi ratory breathi ng c i rcu it or
system, a nd optiona lly an i nspi ratory gases cond uit for receivi ng humid ified gases from
the humid ifier outlet a nd di recti ng them t o a patient interface component such as a
patient interface, or an intermed iate connector such as a y-piece. The f i rst kit may be
provided as a clea n or steri le kit.

[00275] The second kit may comprise a patient interface, a nd a f i lter, or an in-l ine
f i lter, for connection between a patient interface. This may faci litate the multi-patient
usa bil ity of the hu mid ification assembly or kit, by provid i ng a s i ng le patient use patient
interface, with a f i lter t o ensure a con nected hu mid ification assembly or kit rema ins clea n
between patients. Further, the f l uid reservoir 2 provides a reservoi r of humid ification f l u id
t o replenish the humidification f l u id in the hu mid ification cha mber 3 that has been lost or
used up du r i ng operation of the respi ratory support system - w h ich provides for use with
multi ple patients - w h i le at the sa me t i me red uci ng or e l i m i nati ng the need t o consta ntly
re-fi ll or re-charge the humid ification cha mber 3 ma nua lly. The second kit may be
provided as a clea n or steri le kit.

[00276] It w i ll be understood that any of the abovementioned kits or assembl ies, or


any of thei r component pa rts, may be provided together in any combi nation as a kit or
assembly. For exa mple, as a kit for use in theatre, where some of the components may
be for multi ple patient use, a nd some may be for i nd ivid ua l patient use, a nd where some
or all of the components of the kit may be provided clea n or steri le, as described a bove.

[00277] The humid ification cha mber 3 a nd the f l uid reservoi r 2 of the humid ification
assem bly or kit 1 may be provided as sepa rate component pa rts, and when connected by
a user (for exa mple via a conduit 4), the connection may be sufficient t o resist
disconnection, and/or may be perma nent and/or a one-ti me connection .
[00278] The f l uid reservoi r 2 may be config ured t o receive, (a nd t o del iver t o a
humid ification cha mber 3 via a cond uit 4 a nd one-ti me connection), l iqu id water, for
exa mple d isti l led water, or f l uid that is steri le, substa ntia lly pu re, and/or does not conta in
solutes. As an exa mple, steri le water may already be present in a theatre or su rgery
envi ronment for other uses, a nd this water may be used t o f ill the flu id reservoi r 2 via the
inlet port 17.

[00279] The respiratory support system described above may be config ured t o del iver
humidified gases t o a user or patient, and may comprise a flow source, a patient
interface, a nd the humid ification assembly or kit as descri bed herei n. Add itiona lly, the
humid ification cham ber 3 may be in f l uid communication with the flow source a nd the
patient interface.

[00280] The flow source may be opera ble t o provide a gas flow rate of at least about
5 LPM, or about 20LPM t o about 90 LPM, or about 40LPM t o about 70LPM, or up t o about
150LPM .

[0028 1] S i m i la rly, the flow source may be operable t o provide and/or the respiratory
support system is opera ble t o del iver t o a patient, a gas flow rate of g reater tha n or eq ua l
t o about 5 or 10 litres per m i nute ( 5 or 10 LPM) . I n other config urations, the gas flow
rate may be about 5 or 10LPM t o about 1 50LPM, or about 15LPM t o about 95LPM, or
about 20LPM t o about 90LPM, or about 25LPM t o about 85LPM, or about 30LPM t o about
80LPM, or about 35LPM t o about 75LPM, or about 40LPM t o about 70LPM, or about 45LPM
t o about 65LPM, or about 50LPM t o about 60LPM . For exa mple, accord i ng t o those
various embod iments a nd config urations descri bed herei n, a flow rate of gases suppl ied
or provided t o an interface or via a system or from a flow source, may comprise, but is
not li mited to, flows of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 1 10,
120, 130, 140, 150 L/mi n, or more, a nd useful ra nges may be selected t o be any of
these val ues (for exa mple, about 20 t o about 90 L/min, about 40 t o about 70 L/mi n,
about 40 t o about 80 L/mi n, about 50 t o about 80 L/m i n, about 60 t o about 80 L/mi n,
about 70 t o about 100 L/mi n, about 70 t o 80 L/mi n) .

[00282] This invention d iscloses perma nent connections between a f l uid reservoi r 2
(e.g . a water bag) a nd a hu midification cha mber 3 via a conduit 4 (e.g . a tubing) ; i .e. a
perma nent or one-ti me con nection provided between a f l uid reservoi r 2 a nd one end of a
cond uit 4, a nd a perma nent or one-ti me connection between a humid ification cha mber 3
a nd another end of the condu it 4 .

[00283] The arra ngement descri bed above is an atypica l set-up a nd serves the
purpose of ensuri ng only water is used in a humidification system, as the user is una ble
t o accidenta lly spike (con nect to) a bag conta i n i ng a f l uid other tha n water. This problem
is not recog nized in the art, which genera lly prefers flexi b i lity in allowi ng con nections t o
ma ny different types of f l uids. Accordi ngly, a ppl ica nts have su rprisi ng ly found that
perma nently connecting these components provides adva ntages such as improved
patient safety and ease of use for the med ical staff in the operati ng theatre.

[00284] Testi ng was done t o ensure the force requ i red t o sepa rate:
o The flu id reservoi r connector a nd the f l uid reservoi r
o The flu id reservoi r connector and/or the humid ification cha mber connector
a nd the cond uit
is at least 30 N.

[00285] This force requ irement was found t o be satisfied when the connections were
uncond itioned, tra nsport conditioned, duration of use cond itioned and shelf life
cond itioned .

[00286] The method for testi ng involved mounti ng the hum id ification cha mber in a
test rig with the perma nent connections bei ng axial ly al ig ned with a load cell that was
attached t o the f l uid reservoi r . Pea k tension was then recorded du ring a 500mm/mi nute
extension unti l fa il ure. The fail ure mode was a lso recorded .

[00287] The fa il ure modes i ncl uded a brea k a long the interconnecti ng cond uit, a
brea k at the hu mid ification cha mber con nection or the ba rb ada ptor s l i ppi ng from the
interconnecti ng tube.

[00288] When the sa mples were uncond itioned, the pea k tension or force ra nged
from about 50N t o about 70N . There was about 50% fa il ure d ue t o the ba rb ada pter
sli ppi ng from the cond uit a nd 50% fa il ure from a brea k in the con nection at the
humid ification cha mber. There was no fa il ure in cond uit brea k i ng .

[00289] When the sa mples were conditioned t o s i mu late tra nsportation stresses, the
pea k force ra nged from about 50N t o about 70N . There was about 95% fa il ure due t o the
barb ada pter s l i ppi ng from the cond uit and 5% fa il ure from a break in the connection at
the humid ification cha mber. There was no fa il ure in cond uit brea k i ng .

[00290] When the sa mples were conditioned t o s i mulate the stresses d uri ng use ( i n
this test, the duration of use was 7 days) the pea k force ra nged from about 50N t o about
80N . There was about 55% fa il ure d ue t o the ba rb ada pter s l i ppi ng from cond uit a nd
45% fai lu re from a brea k in the connection at the humid ification cha mber.

[0029 1] When the sa mples were cond itioned at 60 ° C t o the eq uiva lent of 2 years
storage/shelf-l ife, the pea k force ra nged from about 40N t o about 70N . There was 100%
fa il ure d ue t o the ba rb ada pter s l ipping from cond uit. There was no fail ure by either a
break in the conduit or a break in the connection at the humidification chamber. The
shelf-life conditioned samples were estimated t o have a 5.6-8.3N (drop of 9.0-13.3%)
effect on the mean retention force but the samples were still above the minimum
required 30N.

[00292] Where, in the foregoing description reference has been made t o integers or
components having known equivalents thereof, those integers are herein incorporated as
if individually set forth.

[00293] I n the foregoing description, the terms 'permanent' and 'permanently' are
intended t o include the terms 'one-time', 'secured', 'resilient', 'resistant (to
disconnection)', 'non-releasable', 'durable' and/or 'enduring', used in regard t o the
connection established between any or all of a fluid reservoir, a conduit, and a
humidification chamber. The terms 'permanent' or 'permanently' are intended t o describe
a connection that, when formed, is not separable in the normal use of equipment
containing these components. Put another way, by use of permanent connection, or the
related terms outlined herein, it is meant that said connection cannot be undone by the
application of forces which are experienced during normal use of the assembly or kit, and
there is no mechanism for releasing the connection, or disengaging any protrusions or
formations that may enable the permanence of the connection, without either damaging
one or more component parts of the assembly, or applying a force between components
that exceeds a pre-determined threshold force along an axis of engagement of a
connection.

[00294] Although the present disclosure has been described in terms of certain
embodiments, other embodiments apparent t o those of ordinary skill in the art also are
within the scope of this disclosure. Thus, various changes and modifications may be
made without departing from the spirit and scope of the disclosure. For instance, various
components may be repositioned as desired. Moreover, not all of the features, aspects
and advantages are necessarily required t o practice the present disclosure. Accordingly,
the scope of the present disclosure is intended t o be defined only by the claims that
follow.
CLAIMS

1. A humid ification assembly or kit for use in a respi ratory support system for
del iveri ng humid ified gas t o a user or patient, comprising :
a h um idification chamber configu red for receivi ng a source of humid ification f l uid,
a f l uid reservoi r config u red for provid i ng the source of humid ification f l uid for
supply t o the h um id ification cha mber,
a cond uit provided as an interconnect between the hu midification cha mber a nd
the f l uid reservoi r config ured for provid ing the sou rce of hum id ification flu id, a nd
wherei n, a connection is provided as a perma nent connection between each of:
- the cond uit a nd the hu mid ification cha mber, a nd
- the cond uit a nd the flu id reservoi r .

2. A humid ification assembly or kit for use in a respi ratory support system for
del iveri ng humid ified gas t o a user or patient, comprising :
a h um idification chamber configu red for receivi ng a source of humid ification f l uid,
a f l uid reservoi r config u red for provid i ng the source of humid ification f l uid for
supply t o the h um id ification cha mber,
a cond uit provided as an interconnect between the hu midification cha mber a nd
the f l uid reservoi r config ured for provid ing the sou rce of h um id ification flu id, a nd
wherei n, a connection is provided with a pre-determi ned force of retention and/or
resista nce t o disconnection between each of:
- the cond uit a nd the hu mid ification cha mber, a nd
- the cond uit a nd the flu id reservoi r .

3. The humidification assembly or kit of cla im 1 or 2, wherei n the connection is one


or more of:
wherei n the connection is configured such that, the or a cond uit provid i ng for the
f l uid communication is resistant to, or unable t o be d iscon nected,
wherei n the connection is configured such that disconnection results in da mage t o
the f l uid communication,
- wherei n sepa ration or discon nection of the connection serves t o destructively
sever the connection,
wherei n sepa ration or disconnection of the connection is destructive of one or
more components or pa rts which formed the connection,
- wherei n sepa ration or d iscon nection of the connection serves t o prevent a
subseq uent re-esta bl ishment of a connection .
4. The hu midification assembly or kit of a ny one of cla i ms 1-3, wherei n a f irst end of
the cond uit is con nected or coupled t o the f l uid reservoir, or a com ponent connected t o or
coupled t o the f l uid reservoi r .
5. The hu midification assembly or kit of a ny one of cla i ms 1-4, wherei n a second end
of the cond uit is connected or coupled t o the humid ification cham ber or a component
connected t o or coupled t o the humid ification cha mber.

6. The hu mid ification assembly or kit of any one of cla i ms 1-5, wherei n the cond uit is
provided as the f l uid connection between the flu id reservoi r and the humid ification
cha mber, a nd is config ured for providi ng the source of humid ification f l uid .

7. The hu midification assembly or kit of any one of cla i ms 1-6, wherei n the cond uit is
provided as a f l uid interconnect between the humid ification cha mber a nd the f l uid
reservoir config ured for provid i ng the source of humid ification f l u id, a nd
wherei n, the con nection is esta bl ished between each of:
- the cond uit a nd the hu mid ification cha mber, a nd
- the cond uit a nd the flu id reservoi r .

8. The hu midification assembly or kit of any one of cla i ms 1-7, wherei n the
connection between the cond uit a nd humid ification cha mber is made by one or more of:
- a ba rbed-type con nector,
- a structu ra l formation provid i ng for a physica l inter-connect,
- an interference or friction fit or push-fit,
- an adhesive,
- solvent bond i ng,
- heat sea l ing,
- a threaded connection .

9. The hu midification assembly or kit of any one of cla i ms 1-8, wherei n the
connection between the cond uit a nd sa id f l uid reservoir is made by one or more of:
- a ba rbed-type con nector,
- a structu ra l formation provid i ng for a physica l inter-connect,
- an interference or friction fit or push-fit,
- an adhesive,
- solvent bond i ng,
- heat sea l ing,
- a threaded connection .

10. The hu mid ification assembly or kit of any one of cla i ms 1-9, wherei n a f l uid
reservoir end of said condu it comprises a f l uid reservoi r connector t o provide the
connection between said device or the cond uit a nd the f l uid reservoi r .
11. The hu midification assembly or kit of any one of cla i ms 1-1 0, wherei n a
humid ification cha mber end of sa id conduit com prises a hu midification cha mber
connector t o provide the connection between the cond uit a nd the humid ification cham ber.

12. The hu midification assembly or kit of any one of cla i ms 1-1 1, wherei n the cond uit
comprises :
- a f l uid reservoi r connector at a f l uid reservoi r end of sa id cond uit, and
- a hum id ification cha mber connector at a humid ification cha mber end of sa id
cond uit,
wherei n each of sa id f l uid reservoi r connector a nd sa id humid ification cha mber
connector provide sepa rately made connections between the condu it a nd the f l u id
reservoir a nd the cond uit a nd the humidification cha mber.

13. The hu mid ification assembly or kit of clai m 12, wherei n the f l uid reservoi r
con nector and/or the humid ification cha mber connector comprises a lead-i n portion
substa ntia lly at or towa rd one end of sa id connector, said lead-i n portion t o faci litate a
connection between :
- the f l uid reservoi r connector a nd the f l uid reservoir, and/or
- the humid ification cha mber connector a nd the hu mid ification cha mber.

14. The hu mid ification assembly or kit of cla im 13, wherei n the lead-i n portion is a
t a pered region, wherei n optiona lly the t a pered reg ion is t a pered t o provide for a relatively
na rrowed neck of a relatively sma ller dia meter t o receive sa id cond uit or t o be received
by the f l uid reservoir or the humid ification cha mber.

15 . The hu midification assembly or kit of cla im 13 or 14, wherei n the lead-i n portion
is sha ped so as t o faci litate the subseq uent esta bl ishment of connection .

16. The hu midification assembly or kit of any one of cla i ms 12- 15, wherei n the f l uid
reservoir con nector and/or the hu mid ification cha mber con nector is substa ntia lly
inflexi ble, or substa ntia lly non-conforma ble, or su bstantial ly rig id, or optiona lly wherei n
the f l uid reservoi r connector and/or the humid ification cha mber connector is formed of a
polypropylene.

17. The hu midification assembly or kit of any one of cla i ms 12- 16, wherei n the f l uid
reservoir con nector is a substa ntial ly longitud inal component comprisi ng a first end
configu red t o be received by the flu id reservoi r, a nd a second end config ured t o be
received by the cond uit.

18. The hu mid ification assembly or kit of clai m 17, wherei n the f l uid reservoi r
con nector comprises a lead-i n portion at or towa rd the first end, and/or a ba rb-type
portion at or towa rd the second end, optiona lly wherei n sa id barb-type portion is
config ured t o reta in sa id conduit once sa id connection is esta blished .

19. The hu mid ification assembly or kit of cla im 18, wherei n at least one rad ia lly
outwa rd projection extends from an outer surface of the f l uid reservoi r con nector, said at
least one rad ia lly outwa rd projection located intermed iate of the lead-i n portion a nd the
second end, and/or sa id at least one rad ial ly outward projection is or comprises of a
barb-type a rra ngement, config ured t o reta in sa id f l uid reservoi r once sa id connection is
esta blished, and/or a lead i ng edge or lead i ng surface of sa id at least one outwa rd
projection is leadi ng with respect t o an edge or surface of the projection(s) which is/a re
t o preferentia l ly ma ke contact with sa id f l u id reservoi r .

20. The hu mid ification assembly or kit of cla im 19, wherei n a col la r is located
intermed iate of the at least one radia lly outwa rd projection a nd the second end, and/or
wherei n the col la r provides for at least two seati ng surfaces, a f i rst of sa id seati ng
surfaces provided t o substa ntia lly face towa rd the first end a nd a second of sa id seati ng
surfaces provided t o substa ntia lly face towa rd the second end, optiona lly wherein each
seati ng surface of the at least two seati ng surfaces is provided as a contin uous or
disconti nuous su rface.

2 1. The hu mid ification assembly or kit of cla im 20, wherei n the col la r extends rad ia lly
outwa rd ly from the outer surface of the flu id reservoi r connector, the col la r dimensioned
t o have a longitud i na l t h ickness config ured t o sepa rate a termi na l end of the cond uit from
a f l uid reservoi r connection poi nt.

22. The humidification assembly or kit of cla im 20 or 2 1 , wherei n a leadi ng edge or


lead i ng surface of sa id at least one outwa rd projection is lead i ng with respect t o an edge
or surface of the projection(s) w h ich is/a re t o preferentia l ly ma ke contact with sa id f l uid
reservoir.

23. The hu midification assembly or kit of any one of cla i ms 20-22, wherei n the at
least one rad ia lly outwa rd projection extends outwa rd ly of the outer surface t o a
substa ntia lly lesser extent or d ia meter tha n sa id col la r .

24. The hu midification assembly or kit of a ny one of cla i ms 20-23, wherei n the col la r
extends su bsta ntia l ly radial ly outwa rd ly of the outer surface t o a substa ntial ly greater
extend or dia meter tha n sa id outwa rd projection.

25. The hu midification assembly or kit of any one of cla i ms 20-24, wherei n the ba rb-
type portion is located substa ntia lly at or towa rd sa id second end, a nd is located
intermed iate of the col la r a nd the second end .
26. The hu midification assembly or kit of any one of cla i ms 20-25, wherei n the
externa l d ia meter of the connector between the second end of sa id con nector a nd the
col la r comprises a f i rst long itud i na l length d ia meter a nd a second longitud ina l d ia meter,
the f i rst long itud i na l d ia meter is su bsta ntia lly sma ller tha n the second long itud i na l
d ia meter, wherei n the f i rst long itud i na l d ia meter is at the second end a nd the second
long itud i nal d ia meter is longitud i na lly d isplaced from the second end a nd more towa rd
the col la r .

27. The hu mid ification assembly or kit of clai m 26, wherei n the ba rb-type portion is
located withi n a reg ion of the f irst long itudi na l length d ia meter.

28. The hu midification assembly or kit of any one of cla i ms 12-27, wherei n the f l uid
reservoir con nector and/or the h umid ification chamber connector comprise a l umen or
passageway for ena bl i ng flu id com mun ication between the f i rst end a nd the second end .

29. The hu mid ification assembly or kit of any one of cla i ms 12-28, wherei n a force
req u i red t o sepa rate the f l uid reservoir con nector and/or the hum id ification cha mber
con nector a nd the condu it is at least about 20N .

30. The hu midification assembly or kit of any one of cla i ms 12-29, wherei n a force
req u i red t o sepa rate the f l uid reservoir con nector and/or the hum id ification cha mber
connector a nd the conduit is either: about 20N t o about 1 10N, or about 30N t o about
100N .

3 1. The hu mid ification assembly or kit of any one of cla i ms 12-30, wherei n a force
req u i red t o sepa rate the f l uid reservoir con nector a nd the f l u id reservoi r is at least about
20N .

32. The hu mid ification assembly or kit of any one of cla i ms 12-31, wherei n a force
req u i red t o sepa rate the f l uid reservoir con nector a nd the f l uid reservoi r is either: about
20N t o about 200N, or about 30N t o about 100N .

33. The hu mid ification assembly or kit of any one of cla i ms 1-32, wherei n a force
req u i red t o sepa rate the cond uit a nd the h um idification cha mber and/or f l uid reservoi r is
at least about 20N .

34. The hu mid ification assembly or kit of any one of cla i ms 1-33, wherei n a force
req u i red t o sepa rate the cond uit a nd the h um id ification cha mber and/or f l uid reservoi r is
either: about 20N t o about 1 10N, or about 30N t o about 100N .
35. The hu mid ification assembly or kit of any one of cla i ms 1-34, wherei n a force
req u i red t o separate or disconnect the h umid ification assembly, or one or more
components of the hu mid ification assembly, is at least about 20N .

36. The hu mid ification assembly or kit of any one of cla i ms 1-35, wherei n a force
req u i red t o separate or disconnect the h umid ification assembly, or one or more
components of the humidification assembly is either: about 20N t o about 200N, or about
30N t o about 100N .

37. The hu mid ification assembly or kit of any one of cla i ms 35 or 36, wherein a
sepa ration of one or more components of the humid ification assembly ca uses destruction
of at least one component of the h um idification assembly.

38 . The humid ification assem bly or kit of any one of clai ms 1-37, wherei n the conduit
is flexi ble.

39. The hu midification assembly or kit of a ny one of cla i ms 1-38, wherei n the cond uit
has a length for creati ng sufficient pressure t o supply flu id from the f l uid reservoi r t o the
humidification cha mber.

40. The hu midification assembly or kit of any one of cla i ms 1-39, wherei n the cond uit
is about 0 . 5m t o 2m in length .

4 1. The hu midification assembly or kit of a ny one of cla i ms 1-40, wherei n the f l uid
reservoir comprises a t a pered base or floor which leads t o an outlet port or t o a f l uid
outlet correspond i ng to, or associated with, a f l uid reservoi r connection poi nt.

42. The hu midification assembly or kit of a ny one of cla i ms 1-41, wherei n the f l uid
reservoir comprises at least one inlet port ca pa ble of bei ng sea led or closed, sa id inlet
port for receivi ng a supply of humid ification f l u id .

43. The hu mid ification assembly or kit of cla im 42, wherei n the inlet port is ca pa ble of
bei ng sea led or closed by a l id or a cap, optiona lly the lid or ca p is attached or reta i ned t o
the f l uid reservoi r or the inlet port by a flexi ble a rm or stra p .

44. The hu midification assembly or kit of cla im 42 or 43, wherei n the flu id reservoi r is
cha rged or re-cha rged with sa id humidification f l u id (e.g . f i l la ble and/or refi l la ble) via the
inlet port.

45. The hu midification assembly or kit of a ny one of cla i ms 1-44, wherei n the f l uid
reservoir comprises an attachment for securi ng t o or ha ng i ng the flu id reservoi r from a
support.
46. The hu mid ification assembly or kit of any one of cla i ms 1-45, wherei n the f l uid
reservoir has a capacity of about 1L .

47. The hu midification assembly or kit of any one of cla i ms 1-46, wherei n the f l uid
reservoir is a water bag .

48. The hu mid ification assembly or kit of any one of cla i ms 1-47, wherei n the
humidification assembly further com prises a control ler t o control a rate of flow of a f l uid
t o be received from the f l uid reservoir, or a rate of flow of a flu id t o be d ischa rged or
released from the f l uid reservoi r, or controls a rate of flow of a f l uid t o be ad mitted t o the
humidification cha mber.

49. The hu midification assembly or kit of any one of cla i ms 1-48, config ured for use or
coupli ng or provided as pa rt of a hig h flow respi ratory support system or a h igh flow
respi ratory support c i rcuit comprisi ng a flow source (or flow generator) a nd a patient
interface.

50. The hu mid ification assembly or kit of cla im 49, wherei n the patient interface is of
a sea li ng or a non-sea li ng type.

51. The hu midification assembly or kit of cla im 49 or 50, wherei n the respi ratory
support system and/or the h um idification assembly or kit further com prises :
a d ry li ne or a conduit for di recti ng a source of respi ratory gas t o a humid ification
cha mber or for provision t o a respiratory breathi ng c i rcuit or system, and/or an
i nspi ratory condu it.

52. The hu mid ification assembly or kit of any one of cla i ms 1-5 1, wherei n the
humid ification assembly or kit has a pre-determi ned period of in-use ca pa b i lity.

53. The hu midification assembly or kit of any one of cla i ms 1-52, wherei n the
humid ification f l uid is water, hypotonic water, and/or disti l led water.

54. The hu mid ification assembly or kit of any one of cla i ms 1-53, wherei n water
conta i ned in or t o be added t o the f l uid reservoir is su bsta ntia lly pu re, and/or does not
conta in solutes.

55. A humid ification assembly or kit for use in a respi ratory support system for
del iveri ng humid ified gas t o a user or patient, comprising :
a f l uid reservoi r, a nd
a h um idification cha mber,
wherei n the f l uid reservoir and the humid ification cha mber a re provided in f l uid
connection with each other, a nd
wherei n, a connection between each of the f l uid reservoi r a nd the humid ification
cha mber provides a pre-determined force of retention and/or resista nce t o disconnection .

56. The hu mid ification assembly or kit of cla im 55, wherei n the connection between
each of the f l uid reservoi r a nd the hum idification cha mber provides for a pre-determined
force of retention and/or resista nce t o d iscon nection such that sa id connection is
destructively severed u pon a ppl ication of a disconnection force above sa id pre¬
determ i ned force.

57. The hu midification assembly or kit of cla im 55 or 56, wherei n a pa rt or component


of the humid ification assembly or kit is destroyed when the connection is subject t o a
disconnection force above sa id pre-determi ned force.

58. A humid ification assembly or kit for use in a respi ratory support system for
del iveri ng humid ified gas t o a user or patient, comprising :
a h um idification chamber configu red for receivi ng a source of humid ification f l uid,
a f l uid reservoi r config u red for provid i ng the source of humid ification f l uid for
supply t o the hum id ification cha mber, a nd
wherei n a perma nent connection is provided for a f l uid connection between the f l uid
reservoir a nd the humid ification cha mber.

59. The hu mid ification assembly or kit of any one of cla i ms 55-58, wherei n a device
provides for a f l uid con nection from the f l uid reservoi r a nd the humid ification cha mber.

60. The hu mid ification assembly or kit of clai m 59, wherei n the device provid i ng for
the f l uid connection is a cond u it.

6 1. A respiratory support system for del iveri ng hu mid ified gas t o a user or patient,
comprisi ng :
a flow source,
a patient interface, and
the humidification assembly or kit of any one of cla i ms 1-60,
wherei n the humid ification chamber is in f l u id commun ication with the flow source
a nd the patient interface.

62. The respi ratory support system of cla im 61, wherei n the flow source is operable t o
provide a gas flow of about 20LPM t o about 90LPM .

63. The respi ratory su pport system of cla im 6 1 or 62, config ured for use or coupli ng or
provided as pa rt of a high flow respi ratory support system or a hig h flow respi ratory
support c i rcuit comprisi ng a flow sou rce (or flow generator) a nd a patient interface.
64. The respi ratory su pport system of any one of cla i ms 61-63, wherei n sa id assembly
or kit comprises a f i rst assembly or f i rst kit provid i ng components for conti nued use with
multi ple patients, a nd a second assembly or second kit provid i ng components for
i nd ivid ua l use with an i nd ivid ua l patient.

65. The respi ratory su pport system of any one of cla i ms 61-64, wherei n the f i rst
assem bly or f i rst kit comprises the assembly or kit as defi ned in any one of cla ims 1-60.
INTERNATIONAL SEARCH REPORT International application No.
PCT/IB2019/057304

A. CLASSIFICATION OF SUBJECT MATTER


A61M 16/16 (2006.01 ) A61M 16/00 (2006.01) A61M 1/00 (2006.01) A61M 16/08 (2006.01) A61M 16/10 (2006.01)

According to International Patent Classification (IPC) or to both national classification and IPC
B . FIELDS SEARCHED
Minimum documentation searched (classification system followed by classification symbols)

Documentation searched other than minimum documentation to the extent that such documents arc included in the fields searched

Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
EPOQUE INTERNAL with Logical database PATENW IPC/CPC: A61M16/10, A61M16/16, A61M16/0816, A61M16/0875, A61M16/08,
A61M1 6/162, A61M2039/1 027, A61 M2039/1061 , A61 M39/10, A61 M39/12 & keywords water, liquid, container, bag, reservoir, tank, bottle,
plug, connector, couple, tube, pipe, conduit, permanent, thread, seal, adhesive, bond, glue, break, destroy, destruction, friction, snap, quick, speed,
push, press, bias, lock, tab, force, newton, tension, resist, avoid, prevent, disconnect, detach, unplug and like terms.

Applicant(s)/Inventor(s) name searched in Espacenet, AusPat and internal databases provided by IP Australia.

C. DOCUMENTS CONSIDERED TO BE RELEVANT

X Further documents are listed in the continuation of Box C X See patent family annex

* Special categories of cited documents:


"A" document defining the general state of the art which is not "T" later document published after the international filing date or priority date and not
considered to be of particular relevance in conflict with the application but cited to understand the principle or theory
"D" document cited by the applicant in the international application underlying the invention
"E" earlier application or patent but published on or after the "X" document of particular relevance; the claimed invention cannot be considered
international filing date novel or cannot be considered to involve an inventive step when the document is
taken alone
"L" document which may throw doubts on priority claim(s) or "Y" document of particular relevance; the claimed invention cannot be considered to
which is cited to establish the publication date of another involve an inventive step when the document is combined with one or more other
citation or other special reason (as specified) such documents, such combination being obvious to a person skilled in the art
"O" document referring to an oral disclosure, use, exhibition or other
means document member of the same patent family
"P" document published prior to the international filing date but
later than the priority date claimed

Form PCT/ISA/210 (fifth sheet) (July 2019)


INTERNATIONAL SEARCH REPORT International application No.
PCT/IB2019/057304

Box No. II Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet)

This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following
reasons:
1. | | Claims Nos.:
because they relate to subject matter not required to be searched by this Authority, namely:
the subject matter listed in Rule 39 on which, under Article 17(2)(a)(i), an international search is not required to be
carried out, including

□ Claims Nos.:
because they relate to parts of the international application that do not comply with the prescribed requirements to such
an extent that no meaningful international search can be carried out, specifically:

3. Claims Nos:
because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a)

Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet)

This International Searching Authority found multiple inventions in this international application, as follows:

See Supplemental Box for Details

1 As all required additional search fees were timely paid by the applicant, this international search report covers all
searchable claims.

2. As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite
payment of additional fees.

3. As only some of the required additional search fees were timely paid by the applicant, this international search report
covers only those claims for which fees were paid, specifically claims Nos.:

4. No required additional search fees were timely paid by the applicant. Consequently, this international search report is
restricted to the invention first mentioned in the claims; it is covered by claims Nos.:

Remark on Protest X The additional search fees were accompanied by the applicant's protest and, where applicable,
the payment of a protest fee.

The additional search fees were accompanied by the applicant's protest but the applicable
protest fee was not paid within the time limit specified in the invitation.

No protest accompanied the payment of additional search fees.

Form PCT/ISA/210 (third sheet) (July 2019)


Continuation of: Box III
This International Application does not comply with the requirements of unity of invention because it does not relate to one
invention or to a group of inventions so linked as to form a single general inventive concept.

This Authority has found that there are different inventions based on the following features that separate the claims into distinct
groups:

• Claims 1, 3-28 (in part), 38-54 (in part), 58, 59-65 (in part) are directed to a humidification assembly or kit for use in a
respiratory support system for delivering humidified gas to a user or patient, comprising, a humidification chamber, a fluid
reservoir and a conduit provided as an interconnect between the humidification chamber and the fluid reservoir. The
feature of the connection being provided as a permanent connection between each of the conduit and the humidification
chamber, and -the conduit and the fluid reservoir is specific to this group of claims.

• Claims 2, 3-28(in part), 29-37, 38-54(in part), 55-57, 59-65 (in part) directed to a humidification assembly or kit for use in
a respiratory support system for delivering humidified gas to a user or patient, comprising, a humidification chamber, a
fluid reservoir and a conduit provided as an interconnect between the humidification chamber and the fluid reservoir. The
feature of the connection being provided with a pre-determined force of retention and/or resistance to disconnection
between each of the conduit and the humidification chamber, and the conduit and the fluid reservoir is specific to this
group of claims.

Note: claims 29-37 are all defining “a separation force” and should ultimately be appended to only claim 2 as claim 1 does not
define this feature and therefore they are grouped into the second invention only.

PCT Rule 13.2, first sentence, states that unity of invention is only fulfilled when there is a technical relationship among the
claimed inventions involving one or more of the same or corresponding special technical features. PCT Rule 13.2, second sentence,
defines a special technical feature as a feature which makes a contribution over the prior art.

When there is no special technical feature common to all the claimed inventions there is no unity of invention.

In the above two groups of claims, the identified features may have the potential to make a contribution over the prior art but are not
common to all the claimed inventions and therefore cannot provide the required technical relationship. The only feature common to
both claimed inventions is a humidification assembly comprising a humidification chamber, afluid reservoir and a conduit
interconnecting the humidification chamber and the fluid reservoir.

However this feature does not make a contribution over the prior art because it is generic in the art and exemplified by:

US 7201163 B2 Jiang et al. published 10 April 2007

US 3861386 A Harris et al. published 2 1 January 1975

Therefore there is no special technical feature common to all the claimed inventions and the requirements for unity of
invention are consequently not satisfied a posteriori.

Form PCT/ISA/210 (Supplemental Box) (July 2019)


US 7201 163 B2 10 April 2007 US 2003 136402 A 1 24 Jul 2003
US 7201 163 B2 10 Apr 2007

AU 2003202237 A 1 30 Jul 2003


WO 03059425 A 1 24 Jul 2003

US 9545493 B2 17 January 20 17 US 2013269696 A 1 17 Oct 2013

US 9545493 B2 17 Jan 2017

AU 6570600 A 05 Mar 2001


AU 20052018 17 A 1 26 May 2005
AU 20052018 17 B2 04 Sep 2008
DE 19936499 A 1 08 Feb 200 1
DE 19949283 A 1 19 Apr 2001

DE 19949292 A 1 13 Jun 2001

EP 1210139 A2 05 Jun 2002

EP 1210139 B 1 11 Oct 2006


EP 1669098 A2 14 Jun 2006

EP 1669098 B 1 11 Oct 201 7


EP 2308539 A2 13 Apr 201 1

EP 2308539 B 1 20 Apr 2016


EP 2345449 A2 20 Jul 201 1
EP 2345449 B 1 0 1 May 2019

JP 2003506 161 A 18 Feb 2003

JP 46953 18 B2 08 Jun 201 1


US 7096864 B 1 29 Aug 2006
US 200619 153 1 A 1 3 1 Aug 2006
US 79381 12 B2 10 May 201 1

US 201 1073 109 A 1 3 1 Mar 201 1


US 8469025 B2 25 Jun 2013
US 2015306338 A 1 29 Oct 201 5
US 92721 16 B2 0 1 Mar 2016

US 2015306337 A 1 29 Oct 201 5


US 9302067 B2 05 Apr 2016
US 2016158482 A 1 09 Jun 2016
US 9545494 B2 17 Jan 2017

US 2016095999 A 1 07 Apr 2016


US 955521 1 B2 3 1 Jan 2017

Due to data integration issues this family listing may not include 10 digit Australian applications filed since May 2001.
Form PCT/ISA/210 (Family Annex)(July 2019)
Form PCT/ISA/210 (Family Annex)(July 2019)

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