U.S. patent application number 10/267279 was filed with the patent office on 2003-05-15 for breathing assistance apparatus.
Invention is credited to Gradon, Lewis George, McAuley, Alastair Edwin, Milivojevic, Ivan, Nightingale, Chris Earl.
Application Number | 20030089373 10/267279 |
Document ID | / |
Family ID | 26652287 |
Filed Date | 2003-05-15 |
United States Patent
Application |
20030089373 |
Kind Code |
A1 |
Gradon, Lewis George ; et
al. |
May 15, 2003 |
Breathing assistance apparatus
Abstract
A device for delivering a supply of gases to a user comprising:
a patient interface, in use in fluid communication with said supply
of gases, a forehead support adapted to pivot about said interface
and in use rest on the forehead of a user and configurable at least
in an adjustment mode for selecting a desired fixed relation and a
secured mode for securing said desired fixed relation. In one
embodiment of the patient interface a mask seals against the face
of said user and deliver said gases to the nasal cavity and/or oral
cavity and/or throat of said user without substantial pressure on
the users face.
Inventors: |
Gradon, Lewis George;
(Auckland, NZ) ; McAuley, Alastair Edwin;
(Auckland, NZ) ; Nightingale, Chris Earl;
(Auckland, NZ) ; Milivojevic, Ivan; (Auckland,
NZ) |
Correspondence
Address: |
TREXLER, BUSHNELL, GIANGIORGI,
BLACKSTONE & MARR, LTD.
105 WEST ADAMS STREET
SUITE 3600
CHICAGO
IL
60603
US
|
Family ID: |
26652287 |
Appl. No.: |
10/267279 |
Filed: |
October 9, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10267279 |
Oct 9, 2002 |
|
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PCT/NZ01/00110 |
Jun 14, 2001 |
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Current U.S.
Class: |
128/206.27 ;
128/204.18 |
Current CPC
Class: |
A61M 16/06 20130101;
A61M 16/0069 20140204; A61M 16/0633 20140204; A61M 16/024 20170801;
A61M 16/109 20140204; A61M 16/1075 20130101; A61M 16/0638 20140204;
A61M 16/0622 20140204; A61M 16/0616 20140204; A61M 16/0683
20130101; A61M 16/065 20140204; A61M 16/16 20130101 |
Class at
Publication: |
128/206.27 ;
128/204.18 |
International
Class: |
A62B 018/08; A61M
016/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 10, 2001 |
NZ |
514750 |
Jun 12, 2002 |
NZ |
519541 |
Claims
1. A device for delivering a supply of gases to a user comprising:
a patient interface, in use in fluid communication with said supply
of gases, a forehead support adapted to pivot about said interface
and in use rest on the forehead of a user and means for securing
said forehead support in a substantially fixed relation to said
interface and configurable at least in an adjustment mode for
selecting a desired fixed relation and a secured mode for securing
said desired fixed relation.
2. A device as claimed in claim 1 wherein said interface is a mask
and said mask and said support being configured to in use
substantially seal against the face of said user without
substantial pressure there to and deliver said gases to the nasal
cavity and/or oral cavity and/or throat of said user.
3. A device as claimed in claims 1 or 2 wherein said desired fixed
relation lies at any point within a predetermined angular
range.
4. A device as claimed in claim 3 wherein said means for securing
further comprises a friction engagement whereby said bridge member
may be selectively engaged to said nasal mask in said desired fixed
relation by a friction engagement.
5. A device as claimed in claim 4 wherein said friction engagement
comprises an adjustable clamp engaging at least a first flange of
said nasal mask with a second flange on said bridge member in a
fixed position relative thereto.
6. A device as claimed in claim S wherein said clamp comprises a
elongate member extending through apertures in at least said first
flange and said second flange whereby the rotation thereof, through
a helical thread acting on either said first flange, said second
flange, said bridge member and/or said interface, thereby
increasing or decreasing the compressive pressure of said first
flange on said second flange and thereby varying the frictional
engagement there between.
7. A device as claimed in claim 6 wherein said first flange said
second flange are flat.
8. A device as claimed in claim 6 wherein said first flange and
said second flange are conical.
9. In a CPAP system for delivering gases to a user the improvement
comprising a user interface for communicating said gases to said
user accordingly to the device claimed in any of the proceeding
claims.
10. In a CPAP system as claimed in claim 9 the improvement further
comprising a humidifier in fluid communication with said interfaces
variably humidifies said gases prior to delivery to said user.
Description
[0001] This is a Continuation-In-Part of PCT/NZ01/00110 filed Jun.
14, 2001.
FIELD OF INVENTION
[0002] This invention relates to patient interfaces particularly
though not solely for use in delivering CPAP therapy to patients
suffering from obstructive sleep apnoea (OSA).
BACKGROUND OF THE INVENTION
[0003] In the art of respiration devices, there are well known
variety of respiratory masks which cover the nose and/or mouth of a
human user in order to provide a continuous seal around the nasal
and/or oral areas of the face such that gas may be provided at
positive pressure within the mask for consumption by the user. The
uses for such masks range from high altitude breathing (i.e.
aviation applications) to mining and fire fighting applications, to
various medical diagnostic and therapeutic applications.
[0004] One requisite of such respiratory masks has been that they
provide an effective seal against the user's face to prevent
leakage of the gas being supplied. Commonly, in prior mask
configurations, a good mask-to-face seal has been attained in many
instances only with considerable discomfort for the user. This
problem is most crucial in those applications, especially
applications, which require the user to wear such a mask
continuously for hours or perhaps even days. In such situations,
the user will not tolerate the mask for long durations and optimum
therapeutic or diagnostic objectives thus Will not be achieved, or
will be achieved with great duty and considerable user
discomfort.
[0005] U.S. Pat. No. 5,243,971 and U.S. Pat. No. 6,112,746 are
examples of prior art attempts to improve the mask system. U.S.
Pat. No. 5,570,689 and PCT publication No. WO 00/78384, and U.S.
Pat. No. 6,119,693 are examples of attempts to improve the forehead
rest.
SUMMARY OF THE INVENTION
[0006] It is an object of the present invention to attempt to
provide a patient interface 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.
[0007] Accordingly in one aspect the present invention consists in
a patient interface, in use in fluid communication with said supply
of gases,
[0008] a forehead support adapted to pivot about said interface and
in use rest on the forehead of a user and means for securing said
forehead support in a substantially fixed relation to said
interface and configurable at least in an adjustment mode for
selecting a desired fixed relation and a secured mode for securing
said desired fixed relation.
[0009] Preferably said interface is a mask and said mask and said
support being configured to in use substantially seal against the
face of said user without substantial pressure there to and deliver
said gases to the nasal cavity and/or oral cavity and/or throat of
said user.
[0010] Preferably said desired fixed relation lies at any point
within a predetermined angular range.
[0011] Preferably said means for securing further comprises a
friction engagement whereby said bridge member may be selectively
engaged to said nasal mask in said desired fixed relation by a
friction engagement.
[0012] Preferably said friction engagement comprises an adjustable
clamp engaging at least a first flange of said nasal mask with a
second flange on said bridge member in a fixed position relative
thereto.
[0013] Preferably said clamp comprises a elongate member extending
through apertures in at least said first flange and said second
flange whereby the rotation thereof, through a helical thread
acting on either said first flange, said second flange, said bridge
member and/or said interface, thereby increasing or decreasing the
compressive pressure of said first flange on said second flange and
thereby varying the frictional engagement there between.
[0014] Preferably said first flange said second flange are
flat.
[0015] Preferably said first flange and said second flange are
conical.
[0016] In a second aspect a CPAP system for delivering gases to a
user the improvement comprising
[0017] a user interface for communicating said gases to said user
accordingly to the device claimed in any of the proceeding
paragraphs.
[0018] Preferably the improvement further comprising
[0019] a humidifier in fluid communication with said interfaces
variably humidifies said gases prior to delivery to said user.
[0020] 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.
[0021] The invention consists in the foregoing and also envisages
constructions of which the following gives examples.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] One preferred form of the present invention will now be
described with reference to the accompanying drawings in which;
[0023] FIG. 1 is a block diagram of a humidified continuous
positive airway pressure (system) as might be used in conjunction
with the present invention,
[0024] FIG. 2 is an illustration of the nasal mask in use according
to the preferred embodiment of the present invention,
[0025] FIG. 3 shows a perspective view of the mask with
cushion,
[0026] FIG. 4 is a cutaway view of the mask showing the
cushion,
[0027] FIG. 5 is a cutaway view of the periphery of the outer
membrane,
[0028] FIG. 6 is a cutaway view of the periphery of the mask body
portion,
[0029] FIG. 7 shows the forehead rest in isolation,
[0030] FIG. 8 shows the pivoting forehead rest with a locking
mechanism,
[0031] FIG. 9 is a perspective view of the mask showing the
friction engagement,
[0032] FIG. 10 is an alternate perspective view of the mask showing
the friction engagement, and
[0033] FIG. 11 is a cross section view of the friction
engagement.
DETAILED DESCRIPTION
[0034] The present invention provides improvements in the delivery
of CPAP therapy. In particular a patient interface is described
which is quieter for the user to wear and reduces the side leakage
as compared with the prior art. It will be appreciated that the
patient interface as described in the preferred embodiment of the
present invention can be used in respiratory care generally or with
a ventilator but will now be described below with reference to use
in a humidified CPAP system. It will also be appreciated that the
present invention can be applied to any form of patient interface
including, but not limited to, nasal masks, oral masks and
mouthpieces.
[0035] With reference to FIG. 1 a humidified Continuous Positive
Airway Pressure (CPAP) system is shown in which a patient 1 is
receiving humidified and pressurised gases through a patient
interface 2 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 which contains a volume of
water 6. Inspiratory conduit 3 may contain heating means or heater
wires (not shown) which 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.
[0036] 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 5. As the volume of water 6 within
humidification chamber 5 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's mouth are passed directly to ambient surroundings in FIG.
1.
[0037] Blower 15 is provided with variable pressure regulating
means or variable speed fan 21 which 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.
[0038] Mask
[0039] According to a first embodiment of the present invention the
patient interface is shown in FIG. 2 as a mask. This may be also a
nasal mask, a full face mask, a oral mask endotracheal tube, nasal
cannula or other breathing assistance interface as are known in the
art. The mask includes a hollow body 102 with an inlet 103
connected to the inspiratory conduit 3. The mask 2 is positioned
around the nose of the user 1 with the headgear 108 secured around
the back of the head of the patient 1. The restraining force from
the headgear 108 on the hollow body 102 and the forehead rest 106
ensures enough compressive force on the mask cushion 104, to
provide an effective seal against the patient's face.
[0040] The hollow body 102 is constructed of a relatively
inflexible material for example, polycarbonate plastic. Such a
material would provide the requisite rigidity as well as being
transparent and a relatively good insulator. The expiratory gases
can be expelled through a valve (not shown) in the mask, a simple
vent (not shown), a further expiratory conduit (not shown), or any
other such method as is known in the art.
[0041] Mask Cushion
[0042] Referring now to FIGS. 3 and 4 in particular, the mask
cushion 1104 is provided around the periphery of the nasal mask
1102 to provide an effective seal onto the face of the user to
prevent leakage. The mask cushion 1104 is shaped to approximately
follow the contours of a patient's face. The mask cushion 104 will
deform when pressure is applied by the headgear 1108 to adapt to
the individual contours of any particular user. In particular,
there is an indented section 1150 intended to fit over the bridge
of the user's nose as well as a less indented section 1152 to seal
around the section beneath the nose and above the upper lip.
[0043] In FIG. 4 we see that the mask cushion 1104 is composed of a
inner foam cushion 1110 covered by an outer sealing sheath 1112.
The inner cushion 1110 is constructed of a resilient material for
example polyurethane foam, to distribute the pressure evenly along
the seal around the user's face. The inner cushion 1110 is located
around the outer periphery 1114 of the open face 1116 of the hollow
body 1102. Similarly the outer sheath 1112 may be commonly attached
at its base 1113 to the periphery 1114 and loosely covers over the
top of the inner cushion 1110.
[0044] In the preferred embodiment shown in FIGS. 3-6 the bottom of
the inner cushion 1110 fits into a generally triangular cavity 1154
in the hollow body 1102. The cavity 1154 is formed from a flange
1156 running mid-way around the interior of the hollow body.
[0045] The outer sheath 1112 fits in place over the cushion 1110,
holding it in place. The sheath 1112 is secured by a snap-fit to
the periphery 1114 of the hollow body. In FIGS. 5-6 the periphery
1114 is shown including an outer bead 1158. The sheath 1112
includes a matching bead 1159, whereby once stretched around the
periphery, the two beads engage to hold the sheath in place.
[0046] However it will be appreciated the invention is not limited
to this form of sealing.
[0047] Forehead Rest
[0048] In the preferred embodiment of the present invention the
nasal mask 2102 includes a pivoting forehead rest 106 (seen in
FIGS. 2 and 7). The attachment of the forehead rest 106 to the
hollow body 102 effectively allows the forehead rest 106 to pivot
towards and away from the user but with no lateral movement.
[0049] In one form shown in FIG. 7, pins 2130 are provided mounted
on a base 2132 attached to the hollow body 102. These pins 2130 are
co-axial within cylinders 2131 mounted on a bridge member 2136.
[0050] At the top end 2142 (around the user's forehead) of the
bridge member 2136 harnessing slots 2138 are provided which allow
straps from the headgear to be inserted to secure the mask to the
headgear. For the user's comfort one or more resilient cushions
2140 are provided underneath the top end 2142 of the bridge member
2136, which rest on the forehead of the user. The cushion 2140
might be constructed of silicon or any foam materials as is known
in the art for providing cushioning.
[0051] In a firer embodiment the forehead rest 106 described
previously may include a weakened section 2130 at its base 2132
which allows the joining member 2136 to pivot from the hollow body
102. The bridge member extends up to the forehead of the user. In a
further alternative the mask may include a vertical upwardly
extending inlet In this case the member 2136 is hinged at its base
2132 to either side of the inlet passage. Again the member would
then extend to the forehead.
[0052] In a still further embodiment shown in FIG. 8 the forehead
rest 106 is shown with the pivoting action which can be locked in a
single position. As before the bridge member 136 pivots by virtue
of pins from the hollow body 102 co-operating with cylinders 131 on
the bridge member 136. The locking action is provided by an
engaging clip 200 which is attached through an aperture at the base
of the bridge member 136. The lock and clip 200 has a number of
ribs which engage with at least two ribs on the interior of the
aperture which allows it to lock and place it in at least an upper
position and a lower position. In the upper position the locking
clip 200 is clear of the hallow body 102 and allows the bridge
member 136 to pivot freely. In the lower position the locking pin
200 engages with a cavity on the surface of the said hollow body
102 which locks said bridge member 136 at a predetermined angular
position with respect to said hollow body 102. In the preferred
embodiment this position provides the maximum off set of the upper
section of the mask from the bridge of the patients nose.
[0053] In a still further embodiment shown in FIGS. 9 to 11 the
bridge member 430 according to the present invention is shown
including a friction engagement 432 with the mask body 434. In this
embodiment the mask body 434 is shown with an elbow connector 436
connected to the inlet conduit 438. An adjustment knob 440 provided
on the side of the bridge member 432 allows adjustment. With the
knob 440 in a loosened position the bridge member 430 may be
pivoted to any desired angle with respect to the mask body 434.
Once in the desired position the knob 440 may be configured to a
tightened position whereby the angle of the bridge member 430
relative to the mask body 434 is substantially fixed by virtue of
the friction engagement in the pivot parts. Knob 440 may also be
configured in a partially tightened position whereby the pivot
angle may be adjusted by applying a large force between the
two.
[0054] In more detail shown in FIG. 11 the knob 440 includes a
helical thread engaging with a reciprocal helical thread 441 on pin
442 running transversely through the bridge member 430. The pin
also runs through apertures in two flanges 444, 445 extending up
from the mask body 434 and an internal flanges 446 from the bridge
member 430. In this fashion the body flanges 444, 445 and bridge
flange 446 may frictionally engage (optionally also with the inner
surfaces of the bridge member 430) once the knob 440 is in a
tightened position. More preferably washer 448 is provided between
body flanges 444, 445 and bridge flange 446. Washer 448 improves
the friction engagement and may be formed as a single hard rubber
inset, or two separate washers. Adjustment may either be allowed in
a finite number of predetermined positions or more preferably may
be completely variable.
[0055] In a further variation the body flange and bridge flange may
be conical, or any other configuration allowing pivoting as well as
engagement in a desired relation
* * * * *