U.S. patent application number 10/293759 was filed with the patent office on 2003-05-22 for nasal positive pressure device.
Invention is credited to Doyle, Dominic Robert, McAuley, Alastair Edwin, Smith, Nicholas Charles Alan.
Application Number | 20030094178 10/293759 |
Document ID | / |
Family ID | 19928837 |
Filed Date | 2003-05-22 |
United States Patent
Application |
20030094178 |
Kind Code |
A1 |
McAuley, Alastair Edwin ; et
al. |
May 22, 2003 |
Nasal positive pressure device
Abstract
The present invention relates to apparatus for treating sleep
apnoea. More specifically, the present invention provides a nasal
positive airway pressure device which is reliable and comfortable
to wear and, consequently, more acceptable to the patient. The
nasal device has inflatable cuffs worn in a patient's nasal
cavities. A pair of inflating tubes are in gaseous communication
with the interior of a respective one of the inflatable cuffs and
when pressurised gases flow through each of the inflating tubes,
each of the cuffs inflate to retain the cuff within each of the
nasal cavities of the patient.
Inventors: |
McAuley, Alastair Edwin;
(Auckland, NZ) ; Smith, Nicholas Charles Alan;
(Auckland, NZ) ; Doyle, Dominic Robert;
(Palmerston North, NZ) |
Correspondence
Address: |
TREXLER, BUSHNELL, GIANGIORGI,
BLACKSTONE & MARR, LTD.
105 W. ADAMS STREET
CHICAGO
IL
60603
US
|
Family ID: |
19928837 |
Appl. No.: |
10/293759 |
Filed: |
November 13, 2002 |
Current U.S.
Class: |
128/207.18 ;
128/203.22 |
Current CPC
Class: |
A61M 2210/0618 20130101;
A61M 16/0833 20140204; A61M 16/0666 20130101 |
Class at
Publication: |
128/207.18 ;
128/203.22 |
International
Class: |
A62B 007/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 16, 2001 |
NZ |
515549 |
Claims
What is claimed is:
1. A device for delivering a supply of gases to a patient
comprising or including: a pair of nasal members, the distal end of
each said nasal member defining a cannula, a pair of inflatable
cuff members, each said cuff member surrounding at least a portion
of each of said cannula, a pair of inflating tubes each in gaseous
communication with the interior of a respective one of said cuff
members, said communication provided through an aperture in each of
said cuff members in which a respective one of said inflating tubes
extends there through, a source of pressurised gases connected to
said inflating tubes to deliver pressurized air to the interior of
said cuff members, wherein, in use, when a respective one of said
cuff members is inserted within a respective nasal cavity of said
patient and when said pressurised gases flow through each of said
inflating tubes, each of said cuff members inflate to retain said
cuff members within each of said nasal cavity of said patient.
2. A device for delivering a supply of gases to a patient according
to claim 1 wherein said device includes: a pair of transportation
means, and connecting means, wherein said nasal members are each
connected to said transportation means to supply said gases to each
of said cannula, and said connecting means is substantially
Y-shaped, the arms of said Y-shaped connector adapted to be
connected to a respective one of said pair of transportation
means.
3. A device for delivering a supply of gases to a patient according
claim 2 wherein said connecting means is adapted to be connected to
a supply of said gases.
4. A device for delivering a supply of gases to a patient according
claim 2 wherein said connecting means is connected to said gases
supply by way of a gases pathway that is a flexible conduit that
defines a passage for the flow of gases from said patient
5. A device for delivering a supply of gases to a patient according
to claim 1 wherein said source of pressurised gases comprises a
valve connected to each of said inflating tubes, and a gases
compression means, which pushes gases through said valve and into
said inflating tubes to inflate said cuffs.
6. A device for delivering a supply of gases to a patient according
to claim 5 wherein said valve is a non-return valve.
7. A device for delivering a supply of gases to a patient according
to claim 5 wherein said gases compression means is a syringe
comprising or including: a body part, and reciprocating part,
adapted to be connected and reciprocatable within said body part
and a nib member, wherein, in use, said body part is filled with
gases from the ambient air by pulling said reciprocating part
partially out of said body part drawing said gases into said body
part, and inserting said nib into said inflating tubes and pushing
said reciprocating part back into said body part causing said gases
to be pushed past said valve and into said inflating tubes.
8. A device for delivering a supply of gases to a patient according
to claim 1 wherein said source of pressurised gases is a pump
mechanism comprising or including: a first valve, receiving gases
from the atmosphere, a gases compartment holding said gases, and a
second valve connected to each of said inflating tubes, which said
gases pass through on compression of said gases compartment and
into said inflating tubes.
9. A device for delivering a supply of gases to a patient according
to claim 8 wherein said first and second valves are non-return
valves.
10. A device for delivering a supply of gases to a patient
according to claim 1 wherein said pair of inflating tubes are
flexible conduits of a small diameter that are fitted to and extend
into a respective one of said inflatable cuffs.
11. A device for delivering a supply of gases to a patient
according to claim 1 wherein said device includes: humidification
means in fluid communication with said supply of gases, adapted to
humidify said gases, and gases pathway in fluid communication with
said humidification means and adapted to convey said gases to said
gases pathway.
12. A device for delivering a supply of gases to a patient
according to claim 1 wherein said pair of nasal members have at
least one aperture extending therethrough, said aperture acting as
a vent of gases exhaled from said patients nasal cavities.
Description
BACKGROUND TO THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to apparatus for treating
sleep apnoea. More specifically, the present invention provides a
nasal positive airway pressure device which is reliable and
comfortable to wear and, consequently, more acceptable to the
patient.
[0003] 2. Summary of the Prior Art
[0004] Obstructive Sleep Apnoea (OSA) is a sleep disorder that
affects up to at least 5% of the population in which muscles that
normally hold the airway open relax and ultimately collapse,
sealing the airway. The sleep pattern of an OSA sufferer is
characterised by repeated sequences of snoring, breathing
difficulty, lack of breathing, waking with a start and then
returning to sleep. Often the sufferer is unaware of this pattern
occurring. Sufferers of OSA usually experience daytime drowsiness
and irritability due to a lack of good continuous sleep.
[0005] In an effort to treat OSA sufferers, a technique known as
Continuous Positive Airway Pressure (CPAP) was devised. A CPAP
device consists of a gases supply (or blower) with a conduit
connected to supply pressurised gases to a patient, usually through
a nasal mask. The pressurised air supplied to the patient
effectively assists the muscles to keep the patient's airway open,
eliminating the typical OSA sleep pattern.
[0006] The procedure for administering CPAP treatment has been well
documented in both the technical and patent literature. Briefly
stated, CPAP treatment acts as a pneumatic splint of the airway by
the provision of a positive pressure, usually in the range 4 to 20
cm H.sub.2O. The air is supplied to the airway by a motor driven
blower whose outlet passes via an air delivery hose to a nose (or
nose and/or mouth) mask sealingly engaged to a patient's face by
means of a harness or other headgear. An exhaust port is provided
in the delivery tube proximate to the mask. More sophisticated
forms of positive airway pressure devices, such as bi-level devices
and auto-tritating devices, are described in U.S. Pat. No.
5,148,802 of Respironics, Inc. and U.S. Pat. No. 5,245,995 of
Rescare Limited, respectively.
[0007] U.S. Pat. No. 5,477,852 of Airways Ltd, Inc. discloses a
nasal positive airway pressure device that has a pair of nasal
members each having a cannula tip to be inserted into the nares of
the patient. Each cannula is tapered from a substantially circular
cross-section outside the patient's nostril to a substantially oval
cross-section at the tip inserted into the nostril. An inflatable
cuff surrounds each cannula with the interior space of the cuff
communicating with the lumen of the cannula through at least one
aperture in the sidewall of the cannula. The nasal members are
connected to one or more flexible hoses that, in turn, are
connected to a source of positive air pressure. In use, positive
air pressure is supplied to each cannula tip through the air hoses
and nasal members. The positive air pressure inflates the cuffs to
hold the nasal members in place and to effect treatment. The nasal
device of U.S. Pat. No. 5,477,852 are attached to headgear that is
located about a patient's head. This headgear could be considered
by many patient's as cumbersome and uncomfortable.
[0008] Conventional nasal masks used for administrating CPAP
treatment are also considered uncomfortable and cumbersome, also
prior art nasal masks and the like are noisy, due to air leaks.
These disadvantages in many cases are a formidable obstacle to
patient acceptance of such treatment. Therefore, a substantial
number of patients either cannot tolerate treatment or choose to
forego treatment. It is believed a substantial number of such
patients could benefit from a nasal positive airway pressure
apparatus that is more convenient to use and comfortable to wear,
thereby resulting in increased treatment compliance.
SUMMARY OF THE INVENTION
[0009] It is an object of the present invention to attempt to
provide a nasal positive pressure device which goes some way to
overcoming the abovementioned disadvantages in the prior art or
which will at least provide the industry with a useful choice.
[0010] In a first aspect the present invention consists in a device
for delivering a supply of gases to a patient comprising or
including:
[0011] a pair of nasal members, the distal end of each said nasal
member defining a cannula,
[0012] a pair of inflatable cuff members, each said cuff member
surrounding at least a portion of each of said cannula,
[0013] a pair of inflating tubes each in gaseous communication with
the interior of a respective one of said cuff members, said
communication provided through an aperture in each of said cuff
member in which a respective one of said inflating tubes extends
there through,
[0014] a source of pressurised gases connected to said inflating
tubes to deliver pressurized air to the interior of said cuff
members,
[0015] wherein, in use, when a respective one of said cuff members
is inserted within a respective nasal cavity of said patient and
when said pressurised gases flow through each of said inflating
tubes, each of said cuff members inflate to retain said cuff
members within each of said nasal cavity of said patient.
[0016] To those skilled in the art to which the invention relates,
many changes in construction and widely differing embodiments and
applications of the invention will suggest themselves without
departing from the scope of the invention as defined in the
appended claims. The disclosures and the descriptions herein are
purely illustrative and are not intended to be in any sense
limiting.
[0017] The invention consists in the foregoing and also envisages
constructions of which the following gives examples.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] One preferred form of the present invention will now be
described with reference to the accompanying drawings.
[0019] FIG. 1 is a block diagram of a humidified continuous
positive airway pressure system as might be used in conjunction
with the present invention,
[0020] FIG. 2 is a front view of the nasal plugs and associated
tubing of one embodiment of the present invention, where the nasal
plugs are made from a foam type material,
[0021] FIG. 3 is a close-up front view of the two nasal plugs of
FIG. 2,
[0022] FIG. 4 is a cross-sectional view of a nasal plug of FIG. 2
through AA as shown in FIG. 3,
[0023] FIG. 5 is a front view of one of two nasal plugs of a
further embodiment of the present invention, where the nasal plugs
are made from a silicon type material,
[0024] FIG. 6 is a cross-sectional view of the nasal plug through
BB as shown in FIG. 5,
[0025] FIG. 7 is a front view of the nasal plugs and associated
tubing of yet another embodiment of the present invention, where
the nasal plugs are inflatable cuffs,
[0026] FIG. 8 is a front view of one the inflatable cuffs of FIG.
7,
[0027] FIG. 9 is a cross-sectional view of the inflatable cuff,
through CC as shown in FIG. 8, when the cuff is in the inflated
condition,
[0028] FIG. 10 is a cross-sectional view of the inflatable cuff,
through CC as shown in FIG. 8, when the cuff is in the deflated
condition,
[0029] FIG. 11 is a perspective view of the nasal flap, nasal plugs
and associated tubing of still a further embodiment of the present
invention, where the nasal flap is in the in use, closed
position,
[0030] FIG. 12 is a front view of the nasal flap, nasal plugs and
associated tubing of FIG. 11, where the nasal flap is in the in
use, closed position,
[0031] FIG. 13 is a side view of the nasal flap, nasal plugs and
associated tubing of FIG. 11, where the nasal flap is in the in
use, closed position,
[0032] FIG. 14 is a perspective view of the nasal flap, nasal plugs
and associated tubing of FIG. 11, where the nasal flap is in the
open position,
[0033] FIG. 15 is a front view of the nasal flap and nasal plugs of
FIG. 11, where the nasal flap is in the open position,
[0034] FIG. 16 is a side view of the nasal flap and nasal plugs of
the forth form of the present invention, where the nasal flap is in
the open position,
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] It will be appreciated that the improvements to nasal plugs
as described in the preferred embodiments of the present invention
can be used in respiratory care generally or with a ventilator, but
will now be described below with reference to their use in a
humidified Continuous Positive Airway Pressure (CPAP) system.
[0036] CPAP System
[0037] With reference to FIG. 1 a CPAP system is shown in which a
patient 1 is receiving humidified and pressurised gases through the
nasal device 2, such as nasal cannulae, that are connected to a
humidified gases transportation pathway or inspiratory conduit 3.
It should be understood that delivery systems could also be VPAP
(Variable Positive Airway Pressure) and BiPAP (Bi-level Positive
Airway Pressure) or numerous other forms of respiratory therapy.
Inspiratory conduit 3 is connected to the outlet 4 of a
humidification chamber 5 that contains a volume of water 6.
Inspiratory conduit 3 may contain heating means or heater wires
(not shown) that heat the walls of the conduit to reduce
condensation of humidified gases within the conduit. Humidification
chamber 6 is preferably formed from a plastics material and may
have a highly heat conductive base (for example an aluminium base)
which is in direct contact with a heater plate 7 of humidifier 8.
Humidifier 8 is provided with control means or electronic
controller 9 which may comprise a microprocessor based controller
executing computer software commands stored in associated
memory.
[0038] Controller 9 receives input from sources such as user input
means or dial 10 through which a user of the device may, for
example, set a predetermined required value (preset value) of
humidity or temperature of the gases supplied to patient 1. The
controller may also receive input from other sources, for example
temperature and/or flow velocity sensors 11 and 12 through
connector 13 and heater plate temperature sensor 14. In response to
the user set humidity or temperature value input via dial 10 and
the other inputs, controller 9 determines when (or to what level)
to energise heater plate 7 to heat the water 6 within
humidification chamber S. As the volume of water 6 within
humidification chamber S is heated, water vapour begins to fill the
volume of the chamber above the water's surface and is passed out
of the humidification chamber 5 outlet 4 with the flow of gases
(for example air) provided from a gases supply means or blower 15
which enters the chamber through inlet 16. Exhaled gases from the
patient are exhausted to the ambient surroundings.
[0039] Blower 15 is provided with variable pressure regulating
means or variable speed fan 21 that draws air or other gases
through blower inlet 17. The speed of variable speed fan 21 is
controlled by electronic controller 18 (or alternatively the
function of controller 18 could carried out by controller 9) in
response to inputs from controller 9 and a user set predetermined
required value (preset value) of pressure or fan speed via dial
19.
[0040] Nasal Plugs
[0041] In a general form, the nasal device 2 generally consists of
Y-shaped connector piece that connects the nasal device to the
breathing circuit, transportation passageway or conduit 3, which is
connected to the source of pressurised gas. Each arm of the
Y-shaped connector is connected to a nasal tube, which are each
connected to nasal members. The nasal members have a tapered end
terminating in an aperture (cannula), the tapered end has disposed
about it nasal plugs. In use, when a patient inserts each of the
nasal plugs into their nasal cavities and positive pressure
ventilation therapy is commenced, pressurised gases pass through
the conduit 3, into the Y-shaped connector, through each of the
nasal tubes exiting into the patient's nostrils through each nasal
cannula, thereby administering positive pressure ventilation
therapy to the patient.
[0042] Referring to FIGS. 2 to 4, there is shown a nasal positive
airway pressure device 30 in accordance with a first embodiment of
the present invention. Device 30 consists of a Y-shaped connector
piece 31 (that is connected to the gases outlet end of the conduit
3), and a pair of nasal tubes 32, 33 each terminating in a nasal
member 34, 35. The Y-shaped connector 31 and each of the nasal
members 34, 35 are hollow cylinders or tubes that allow for the
flow of gases therein. The nasal members terminate in an aperture
that is the outlet of pressurised gases from the ventilation system
into the patient's nasal cavities. The end of each nasal member 34,
35 defines a cannula, which is basically a tapered end 36
terminating in an aperture. Fitted about each cannula 36 is a nasal
plug 37, 38 configured and dimensioned to fit within the nasal
cavities of a patient. In the first form of the present invention
the nasal plugs 37 and 38 are made of a foam type material,
preferably a closed-cell foam that has been moulded into the shape
of a nostril, that shape being a generally frustoconical.
[0043] The Y-connector 31 and nasal members 34, 35 are each moulded
from a polycarbonate type material, although other substantially
rigid materials may be used, such as rigid plastics or metal.
Suitable plastics include homopolymers, copolymers, blends and
mixtures of polystyrene, ABS, polycarbonate, acrylics, or
polyethylene. Suitable metals include stainless steel, titanium,
aluminium and alloys thereof One end of each nasal tube 32, 33 is
fitted over the arms 39, 40 of the Y-connector 31 and the other end
of each nasal tube 32, 33 is adapted to be connected to each nasal
member 34, 35, for example the nasal member may be fitted within
the nasal tubes 32, 33. These fittings may be of any convenient
manner suitable for coupling without substantial loss of gas
pressure, such as by friction fit, snap fit, gluing, welding,
threading or the like. The foam nasal plugs 31, 38 are fixed about
the cannulae 36 by appropriate fixing means, for example by gluing,
in a manner that preserves gas pressure.
[0044] The nasal tubing 32, 33 are conduits 44 that is, in the
preferred form, molded from an elastomeric material such as a
Polyethylene/EVA mixture or silicon rubber. The conduit preferably
has a "ribbed" "or corrugated" construction to allow bending, (the
ribs are referenced as 45). This conduit construction may be
accomplished by blowing the molten elastomeric material to form an
endless cylinder that is forced outwards against the internal
surface of a rotating mould that impresses the ribs onto the
conduit. The conduit 44 may also have within it a helically wound
heater wire (not shown) that preferably sits against or adjacent to
the internal wall of the conduit along its length. The purpose of
having a conduit with a heater wire is to reduce the condensation
of the gases within the conduit. The nasal tubing 32, 33 being a
"ribbed" conduit provides the advantage of being able to be easily
manipulated by the patient for additional patient comfort.
[0045] In use, the patient need only apply pressure to the sides of
the foam nasal plugs 37, 38 thereby depressing the foam deforming
the shape of each of the nasal plugs so that each is easily
insertable into each nasal cavity. Once each plug is within each
cavity the foam will expand to its original form where the external
surface of the foam abuts the internal surface of the patient's
nasal cavity, thereby filling the area within each nostril. The
foam nasal plug provides a seal between the cavity and the cannula,
effectively eliminating gases leakage, as the expanding foam
provides an outward force upon the inner surface of each of the
patient's nasal cavities, which also prevents each plug from
falling from the nasal cavity.
[0046] Nasal members 34, 35 have disposed in them at least one, but
preferably a number of, small holes (not shown) that act as vents
to exhaust the gases that are exhaled by the patient. The holes and
thus the nasal members may be covered with an appropriate type of
material that acts as a diffuser.
[0047] In a further form of the nasal device of the present
invention, the nasal plugs may be constructed from a silicon type
material. With reference to FIGS. 5 and 6, the, nasal device in
this form is almost identical to that as shown in FIG. 2, the
difference being the nasal plugs are manufactured from a silicon
type material that is formed in an inverted U-shape. The nasal plug
and nasal member, as shown in FIG. 6, is a cross-section through BB
of FIG. 5. The silicon nasal plug 41 is adapted to be connected to
the tapered end 42 of the respective nasal member 40. This
connection may be provided by any appropriate means as discussed
earlier in relation to the embodiment of the nasal plugs, but more
preferably by a type of glue.
[0048] Again, to allow for exhaust and diffusion of exhaled gases
from the patient each of the nasal members (of which only one,
labelled 40, is shown in FIGS. 5 and 6 have disposed in them at
least one, but preferably a number of, small holes (not shown) that
act as vents to exhaust the gases that are exhaled by the patient
into the ambient air. The holes and thus the nasal members may be
covered with an appropriate type of material that acts as a
diffuser.
[0049] The nasal plug 41 may be made from other appropriately
flexible materials that will be deformed under a pressure applied
by the user of the nasal device. In use, as a patient inserts the
U-shaped plugs into his or her nares the arms of each of the
U-shaped plugs are compressed, effectively reducing the space 43
between the tapered end 42 and the interior surface of the nasal
plug 41. Once the plugs are completely inside the nares, the arms
of each U-shaped plug expand to their natural position, causing the
plugs to be retained within the nares by way of friction.
[0050] In both of the abovementioned forms the nasal plugs provide
a good seal within the patient's nasal cavities, thereby reducing
the effects of gases leakage. As the nasal plugs are deformable,
they are easily fitted by the patient and provide greater patient
comfort when in use. In addition, the forces of the expanding
materials, once inserted, hold the nasal plugs within the nasal
cavities in a manner that is more comfortable to the patient than
prior treatment devices.
[0051] Inflatable Cuffs
[0052] In accordance with a further embodiment of the present
invention, FIGS. 7 to 9 show a nasal device 50 that utilises
inflatable cuffs 51, 52. The cuffs are attached by appropriate
means, for example by moulding or gluing or the like, to the nasal
members 53, 54. The nasal members 53, 54 are adapted to be
connected to nasal tubes 55, 56 and the nasal tubes to the
Y-connector as described above.
[0053] Each inflatable cuff 51, 52 surrounds the tapered end 58
(see FIG. 8) and provides a force, when in use, within the nasal
cavity, to hold the tapered end 58 in position within the patient's
nares in a manner to be explained below. Each tapered end 58 of the
nasal members 53, 54 are preferably substantially oval or
elliptical in cross-section at the open end that is distal to nasal
members 53, 54, and gradually tapers to a substantially circular
cross-section outside the patient's nares. The inflatable cuffs 51,
52 surrounding each tapered end 58 are made of a plastics material,
and a small inflation tube 59, 60, made from a flexible plastics
material communicates with the interior space of each cuff,
preferably through the cuff wall. Both inflation tubes 59, 60 are
connected to an inflation device, where when the inflation device
provides gases to the tubes (59, 60) the cuffs are inflated with
the gases. FIG. 9 shows one such inflatable cuff 51 in
cross-section when the cuff is inflated in an "in use" form,
whereas FIG. 10 shows one such cuff 51' in cross-section when the
cuff is the deflated "insertion" form.
[0054] The inflation device that could be used to provide gases to
the inflation tubes may be a non-return valve with a fitting at one
end, in which a plastic syringe (without the needle) could be
placed. The syringe can then be used to force air into each of the
cuffs. When the syringe is removed the non-return valve would keep
the air in the cuffs. This is similar to the inflation system on an
ET tube. To deflate the cuff, the syringe can be inserted into the
inflating tubes and valve and draw the gases from the cuff.
[0055] Alternatively, a further inflation device is anticipated
which is a small pump mechanism. This would involve having a
plastic gases holding compartment with two non-return valves
attached on either side of the compartment. One valve would allow
air to pass into the compartment from the atmosphere, and once the
compartment is compressed, for example, by the patient's fingers,
gases are forced through the second non-return valve, into the
inflating tubes, inflating the cuffs. To deflate the cuffs, the
pump mechanism would be supplied with a bleed valve, that is
preferably hand operated.
[0056] In use, when the patient wishes to commence positive
pressure ventilation therapy, he or she must place each cuff within
his or her nasal cavities and start the inflation device. As air
flows through the inflation tubes 59, 60 the cuffs 51, 52 will
inflate and provide a force against the internal walls of the nasal
cavities, preventing the cuffs from falling from the cavities.
Again, this embodiment of the nasal plugs of the present invention
has the advantage of providing the patient with a comfortable
alternative to prior art nasal devices.
[0057] Nasal Snap Flap
[0058] In accordance with a fourth form of the present invention,
FIGS. 11 to 16 show a nasal device 60 that utilises an engagement
means located about nasal cannulae to engage and secure the
cannulae within the nares of a patient. The engagement means is a
nasal sealing flap 61. The flap 61 in its natural bias is tapered,
the wide-open end of which is shaped to conform to the facial
contours of a patient's nose around the outside of the nose. Thus
in a closed form, as shown in FIGS. 11 to 13, the flap provides a
cup-like device that is fitted around the patient's nose and
prevent the nasal device 60 from falling from the patients nose. In
the open form, that allows for placement and fitting of the nasal
device 60, the flap 61 is intended to be in a bent back position,
as shown in FIGS. 14 to 16, to aid insertion of the nasal cannulae
63, 64 into the patient's nares.
[0059] The nasal device comprises the nasal sealing flap 61
connected by appropriate means to a nasal member 62 that terminates
in at least one nasal cannula, although in the preferred form two
cannulae 63, 64 are provided, one for each of the patient's nares.
The flap 61 and cannulae 63, 64 may be integrally formed or the
flap 61 may be attached about the cannulae 63, 64 (by appropriate
means, such as gluing) after the cannulae have been formed.
Furthermore, the cannulae 63, 64, flap 61 and nasal member 62 may
all be integrally formed by injection moulding or the like methods.
The cannulae 63, 64 extend through the proximate end of the flap
61, so that in use, upon placing the flap about the patient's nose
the cannulae extend into the nasal cavities of the patient's nose.
The other end of the nasal member 62 is connected, again by
appropriate fixing means, such as by friction fit, snap fit,
gluing, welding, threading or the like, to a nasal tube 65.
[0060] The nasal tube 65 is a conduit that is, in the preferred
form, moulded from an elastomeric material such as a
Polyethylene/EVA mixture or silicon rubber. The conduit preferably
has a "ribbed" "or corrugated" construction to allow bending that
is constructed as described above with relation to the tubing 32,
33 of FIG. 2. The nasal tube 65 is preferably connected to the
inspiratory conduit 3 and thus to the rest of the ventilation
system as detailed with reference to FIG. 1 above. In an
alternative form the nasal tube 65 and conduit 3 may be one
tube.
[0061] In use, to attach the nasal device to the nose and nares,
the patient bends back the flap 61 to the open position, as shown
in FIGS. 14 to 16, and inserts the nasal cannulae 63, 64 into each
nostril. To enable the retaining of the cannulae 63, 64 within the
nares the flap 61 is bent into the closed position, the flap 61
providing a cup-like seal around the patient's nose. The flap is
bent back into the open position to enable removal from the
patient, by simply pressing on its outer periphery 66, until it
snaps into the bent back position, in which it will stay unaided.
The flap 61 may be adjusted into its operational position by
pressing on its outer periphery 66 until it snaps forward to press
against the outside of the nose.
[0062] It will be appreciated that as well as providing a
substantially airtight seal the flap provides enough compressive
force on the nose to keep the nasal device and conduit in place
without the need for straps. This allows the administering of
positive airway pressure ventilation therapy to be considerably
less obtrusive than traditional methods.
[0063] In all forms of the nasal device as discussed above, the
friction between the plugs or cuff of the device and the interior
surface of the patient's nares prevents the plugs or cuffs from
falling from the patient's nares. Although it is appreciated that
headgear could be used to ensure securement of the nasal device to
the patient. Thus, the device may be secured to the head of the
user with headgear (not shown) by attaching straps of the headgear
at an appropriate point along the length of each nasal tube or at
the nasal members. Furthermore, a clip or the like could be used to
attach the tubing associated with the nasal device to the patient's
clothes.
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