Note: Descriptions are shown in the official language in which they were submitted.
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STRAPLESS NASAL INTERFACE DEVICE
10 BACKGROUND OF THE INVENTION
Cross-Reference to Related Applications
[0001] This application claims the benefit of U.S. Provisional
Application No.
61/138,472, filed December 17, 2008, which is hereby incorporated by reference
herein
in its entirety.
Field of the Invention
[0002] The present invention relates to a strapless nasal interface
device, and more
particularly, to a device for use with a ventilator, CPAP, or BIPAP for
strapless interface
with the nasal passages.
Background
[0003] Nasal passage interface devices are commonly used in
conjunction with
CPAP devices, BIPAP, ventilators, and other devices. For example, in CPAP
applications, a nasal passage interface device is used to provide a passageway
for air to
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enter the nasal passages of the user. Such devices must be secured to the
nasal passages
so that it remains in place during sleep.
[0004] Various existing interfaces are typically held in place by
straps or
headgear. Such straps can become uncomfortable to the user, and can deter use
of the
device. Thus, existing devices are deficient in that they fail to provide an
ideal method of
attachment.
[0005] Numerous such interfaces have been disclosed. For example,
U.S. Patent
No. 6,405,729, issued to Thornton, discloses an oral appliance for improving
breathing.
The appliance includes a mouthpiece and two nasal cushions which sit on the
outside of
the nose. The device requires the use of the mouthpiece to hold it in place,
which would
be uncomfortable for a user not in need of the mouthpiece. Without the
mouthpiece, the
nasal interface would not hold the unit in place.
[0006] U.S. Patent No. 6,478,026, issued to Wood, discloses a nasal
ventilation
interface. The unit includes tubes which insert into the nose of the user.
However, the
inserts do not hold the unit in place. The devices requires that the air tubes
be looped
over the ears of the user to hold the unit in place, which would be
uncomfortable and
easily dislodged during sleep.
[0007] Another device is disclosed in U.S. Patent No. 6,581,594,
issued to Drew
et al. In this patent, a cumbersome respiratory mask is disclosed which covers
the nose of
the user. A forehead piece extends from the unit and is attachable to straps
to hold the
unit in place. The device is rather obtrusive and would have both straps to
hold the
device in place and a mask, both of which would be uncomfortable for a user.
[0008] Yet another device is disclosed in U.S. Patent No. 7,000,613,
issued to
Wood et al. In this patent, an interface device also has tubes which extend
into the nasal
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passage. Again, straps in the form of head straps are used to secure the
device, which can
cause discomfort to a user.
[0009] In U.S. Published Patent Application No. 2004/0182397, filed
by Wood, a
ventilation interface is disclosed having tubes extending into the nares of
the nose. In this
disclosure, seal portions inserted into the nostrils are disclosed. However,
these seal
portions are not capable of securing the device to the user, and thus, further
securing
methods such as straps are needed, again causing potential discomfort to the
user.
[0010] Another typical interface device is disclosed in U.S. Published
Patent
Application No. 2007/0272249, filed by Chandran et al. In this device, pillows
are
included which wedge into the nares of the nose. However, again, these pillows
do not
secure the device, and straps of various sorts would be required to hold it in
place.
[0011] While a number of other interface devices have been used or
disclosed,
none of them enable securing via nasal inserts to eliminate the use of straps
or air tube
contraptions to secure the device to the user's nose. Furthermore, they each
pose a level
of potential discomfort to the user which render them problematic for
sleeping.
[0012] Thus, there continues to be a need for a particular suitable nasal
passage
interface device which can be secured without the need for straps or air tube
arrangements, and which provides a greater comfort level to the user.
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SUMMARY
[0013] The present invention is a strapless nasal interface device
for use with a
CPAP or BIPAP device, or any other ventilator type device. The nasal interface
device
of the present invention enables the user to secure the device in place
without the need for
straps or headgear, which can be uncomfortable for the user. Typical PAP
devices are
secured to the user via straps which wrap around the head of the user. These
straps can
be very uncomfortable, and can even deter use of the device altogether. Straps
can be
particularly uncomfortable when the head is tilted in various directions
during sleep.
This problem may also be particularly present in patients having
claustrophobia issues
when headgear or straps can be perceived as enclosing on a patient.
Additionally,
eliminating straps or headgear can make the maintenance and cleaning of the
device
easier. Providing a lightweight device which can be secured without straps or
headgear is
thus most advantageous.
[0014] The nasal interface device of the present invention includes
an interface
body which is preferably light weight and low profile. A ventilation tube is
connected to
the body, such as a tube through which air is supplied via a CPAP or other
device. The
body also includes exhalation holes. Thus, when the user exhales, the carbon
dioxide
rich exhalation air can exit through the exhalation holes, allowing new air to
enter.
[0015] The body of the device interfaces with the nasal passage via
nostril
interface tubes extending from the body. These tubes include a nasal interface
element
designed to aid in securing the device in place, and thus eliminating the need
for straps or
headgear. The nasal interface elements are formed of an expandable,
compressible
material, meaning they can be compressed in order to insert them into the
nostril, and
once inserted they expand to apply pressure to the inner surfaces of the
nostril opening to
hold the device in place. Preferably, the contact is made at the end portion
of the nostril
so that only the section in the nostril covered by skin is contacted, thus
avoiding the more
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sensitive nasal mucosa. Alternatively, the nostril interface elements are held
against the
outer edge of the nostrils.
[0016] These nasal interface elements can be formed of any suitable
material
which can be deformed, but are resilient in that they tend back to their
original shape. A
compressible foam is one material which may be well-suited for use in the
invention.
The interface element can be either permanently mounted to the interface
tubes, or they
may be removable and disposable so that they can be replaced after use. Thus,
they can
be mounted to the tubes via any suitable method. For example, they can be
mounted via
threading, frictional fit, or adhesive. However, other suitable methods of
mounting the
element to the tubes are contemplated and considered within the scope of the
present
invention.
[0017] The nasal interface elements of the present invention are
ideally shaped in
such a manner that they will form a seal or snug fit within the nostril of the
user. This
may mean they have more material on the bottom part toward the user's face, or
that they
may be specially formed to conform to the shape of the interior of the
nostril. By
exerting a small amount of pressure to the inside of the nostril, an
additional advantage
can be obtained by widening the passageway to allow more airflow. Furthermore,
to
enhance the securing of the device, the interface elements may include a mild
adhesive
on their exterior surface to hold them in place against the inner surfaces of
the nostril.
Such adhesive must be mild enough that the element can be easily removed by
the user
without causing significant discomfort or irritation or abrasion.
[0018] Optionally, these interface elements may contain an anti-bacterial
agent to
reduce the growth of contaminants. Once used, the user may replace the
elements onto
the tubes.
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[0019] In various embodiments of the present invention, the interface
tubes may
further include a skirt surrounding the tube below the interface elements.
Such skirts can
be fitted against the outside of the nostril opening to help form a seal.
Optionally, a mild
adhesive can be disposed on the surface of the skirt which touches the outside
edge of the
nasal opening to help hold it in place.
[0020] In various embodiments of the present invention, the device
also includes
one or more flaps to assist in holding the device in place while in use. For
example, side
flaps are optionally included extending from the sides of the body of the
device. The side
flaps have an adhesive, enabling them to be adhered to the outer surface of
the nose of the
user to secure the device in place. Alternatively, the side flaps may
removably secure to
a nose cover which is adhered to the nose of the user.
[0021] Furthermore, an optional front flap may be included. The front
flap
extends from the body of the device and is secured to the exterior surface of
the nose of
the user. It may be secured via a strip of tape, and adhesive on the underside
of the flap,
or by any other suitable method. This front flap holds the device in place
during use. In
certain embodiments, the front flap may include resilient strips traversing
the exterior of
the nasal passageways. These strips can be deformed when applying the front
flap to the
nose via an adhesive, and will apply pressure tending to open the nasal
passageways. A
single one of such strips can be used. Alternatively, multiple strips can be
used. Thus,
the passageway is opened to allow more airflow, reducing the tendency of
snoring in the
user, and potentially reducing the air pressure required through the device to
accomplish
its purpose. Greater airflow may be enhanced by the combination of the strips
and the
expanding nasal interface elements, thus reducing air pressure requirements.
[0022] Still other objects and advantages of the present invention
will become
readily apparent to those skilled in the art from the following detailed
description,
wherein it is shown and described only the preferred embodiments of the
invention,
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simply by way of illustration of the best mode contemplated of carrying out
the
invention. As will be realized, the invention is capable of other and
different
embodiments and its several details are capable of modifications in various
obvious
respects, without departing from the invention. Accordingly, the drawings,
wherein like
reference numerals represent like features, and description are to be regarded
as
illustrative in nature and not as restrictive.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Fig. 1 shows an embodiment of the nasal interface device of
the present
invention.
[0024] Fig. 2 shows another embodiment of the nasal interface device of the
present invention, having optional side and front straps for mounting the
device.
[0025] Fig. 3 shows an embodiment of the nasal interface device of
the present
invention as mounted on the nose of a user.
[0026] Fig. 4 shows an embodiment of the nasal interface element of
the present
invention.
[0027] Fig. 5 shows another embodiment of the nasal interface device
of the
present invention.
[0028] Fig. 6 shows an exploded view of one embodiment of the nasal
interface
device of the present invention.
[0029] Fig. 7 shows a perspective view of one embodiment of the nasal
interface
device of the present invention.
[0030] Fig. 8 shows another embodiment of the nasal interface device
of the
present invention.
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DETAILED DESCRIPTION OF THE INVENTION
[0031] While this invention is susceptible of embodiments in many
different
forms, there are shown in the drawings and will herein be described in detail,
preferred
embodiments of the invention with the understanding that the present
disclosure is to be
considered as an exemplification of the principles of the invention and is not
intended to
limit the broad aspect of the invention to the embodiments illustrated.
[0032] The present invention is a strapless nasal interface device 10
suitable for
use with a CPAP or BIPAP device, or any other ventilator type device. The
device 10
includes an interface body 20 having an interior cavity. The cavity is fluidly
connected to
an air tube 40 extending from the body 20 for use with a CPAP or other device.
The
body 20 ideally includes exhalation holes 30 to enable expelled air to escape
the device
10.
[0033] The device 10 further includes at least one nostril interface
tube 50
extending from the body 20 to interface with the nasal passages of the user.
Preferably,
two such tubes 50 are included. Surrounding the tubes are compressible
expandable
nasal interface elements 60. These elements 60 are formed such that they can
be
compressed to fit within the nostril of the user, after which they expand to
make contact
with the interior of the nostril at the inner edge of the nostril to hold the
interface tube 50
in place within the nostril. Thus, the need for straps or headgear in
conjunction with the
device is eliminated.
[0034] In various embodiments of the present invention, the interface
elements 60
are permanently mounted to the interface tubes 50. However, in various other
embodiments, the interface elements 60 are removably mounted to the tubes 50.
If
removably mounted, the interface elements 60 may be mounted to the tubes 50 by
any
suitable means. For example, they may be threaded, frictionally fit, or
adhered with an
adhesive 62.
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[0035] Interface elements 60 can be formed of any suitable material.
In certain
embodiments, they are formed of an expandable, compressible foam. Preferably,
the
elements 60 have an anti-bacterial agent. Optionally, elements 60 may include
a mild
adhesive 64 on the outer surface to make contact with the skin on the interior
of the
nostril. Ideally, elements 60 form a seal within the nostril. Ideally, they
are shaped to
optimize such a seal. For example, they may be formed to conform to the
interior shape
of the nostril so as to form a proper fit.
[0036] In various embodiments of the present invention, a skirt 70 is also
included. The skirt 70 is disposed on the nostril interface tube 50 between
the interface
element 60 and the interface body 20. The skirt interfaces with the end of the
nostril
opening to help aid in sealing the air passage. Optionally, a mild adhesive
can be
disposed on the surface 75 of the skirt 70 adjacent the rim of the nostril
opening to further
seal the passageway.
[0037] In various further embodiments, the device 10 includes one or
more flaps
in order to further secure it on the user. For example, in certain
embodiments, side flaps
80 extend from the body 20. The side flaps 80 have an adhesive thereon to
adhere the
flaps to the exterior of the nose, further securing it. Side flaps 80 may be
mounted to the
interface body 20 by any suitable method, such as via a groove in the
interface body 20
allowing an end of flap 20 to be inserted. Such a fit may be a friction fit,
or it may be a
dovetail groove. However, any other suitable method of attachment is
contemplated as
within the scope of the invention.
[0038] Additionally, an optional front flap 90 may extend from the
interface body
20. The front flap 90 covers an exterior portion of the nose. It can be
mounted to the
nose via any suitable method. For example, a separate strip of tape or
adhesive may be
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used. In certain embodiments, it may be mounted via an adhesive on the
underside of the
front flap 90. Thus, the device 10 is further secured to the nose of the user.
Front flap 90
may be mounted to the interface body 20 by any suitable method, such as via a
groove in
the interface body 20 allowing an end of flap 90 to be inserted. Such a fit
may be a
friction fit, or it may be a dovetail groove. However, any other suitable
method of
attachment is contemplated as within the scope of the invention.
[0039] In various embodiments, the front flap 90 of the device 10
further includes
tension bows or strips 95. These strips 95 are formed of a resilient material.
Thus, the
strips 95 may be deformed when adhered to the exterior of the nose via an
adhesive on
the underside of the front flap 90, after which they apply pressure tending to
expand the
nasal passageway. Thus, the passageways are expanded, relieving a tendency of
snoring
and potentially reducing the air pressure required for the user's purposes.
While a single
such strip 95 can be used, in certain embodiments multiple strips 95 are used
to open the
passageway along an entire portion of the passageway. The front flap 90 can be
used
without side flaps 80, or in conjunction therewith.
[0040] In various other embodiments, the present invention includes a
strapless
nasal interface device 100 having an interface body 105 having an internal
cavity 110.
The cavity 110 is in communication with an air tube 115 which extends from the
body
105. The air tube 115 is preferably rotatably attached to the interface body
105 at a first
point of attachment 120. Ideally, this point of attachment 120 allows the air
tube 115 to
rotate 360 degrees, yet maintains a substantially leak-proof connection
regardless of how
the air tube 115 is oriented with respect to the interface body 105. A sealing
o-ring may
be incorporated to facilitate the rotatable mounting. This first point of
attachment 120
may be located at any suitable position on interface body 105, however, in a
preferred
embodiment it is located on a front wall which is adjacent the wall on which
nostril
interface tubes 135 are located such that the air tube 115 extends out
perpendicular to the
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plane of the face and away from the face, thus keeping air tube 115 and air
supply tube
125 from rubbing against the face of the user.
[0041] Preferably, the device 100 comprises at least one exhalation
hole, and
preferably a plurality of exhalation ports or holes 122 which are sized to
allow exhaled
air to pass therethrough, but which are sized so that they do not
substantially depressurize
the cavity 110 of the interface body 105. Exhalation holes 122 can be placed
in any
suitable location on the interface body 105. For example, they may be placed
on the side
opposite of where nostril interface tubes 135 are located, or on the top side
of the
interface body 105 near the first point of attachment 120, or in both
locations, or in any
other suitable location. In certain embodiments, 35 to 40 exhalation holes
sized at about
0.023 inches each may be suitable to enable carbon dioxide rich exhalation air
to leave
the cavity 110, yet such holes 122 are small enough such that air pressure
intended to
pressurize the nasal passage is maintained. In another embodiment, hole sizes
may be
approximately 0.02 inches in diameter, and about 78 of them may be suitable.
However,
any size, number, and configuration of exhalation holes 122 which function as
described
is suitable and contemplated within the scope of the present invention.
[0042] In various embodiments, the air tube 115 is also attached to
an air supply
tube 125. Preferably, this is a removable attachment. Optionally, the
connection at a
second attachment point 130 between the air tube 115 and the air supply tube
125 also
allows rotation while maintaining a leak-proof connection. Ideally, 360
degrees of
rotation is enabled. In certain embodiments, the air tube 115 is bent
somewhere along its
length, such that the planes of rotation at the two attachment points 120 and
130 are
different planes of rotation. For example, if the air tube is bent by about 90
degrees, the
planes of rotation will be substantially orthogonal with respect to one
another. In some
embodiments, one plane of rotation will be parallel to the face of the user,
and the other
will be perpendicular to the user. This allows for a great degree of freedom
of movement
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of the user without compromising the integrity of the seal formed between the
device and
the user's nostrils.
[0043] In various embodiments, the device includes at least one
nostril interface
tube 135 having an internal passage extending from the interface body 105 to
the nostrils
of a user. Preferably, there are two such tubes or nostril interface elements
135 extending
to the nostrils of a user. In certain embodiments, the nostril interface
elements 135
include an upper cushion 140, which is a radial protrusion, preferably formed
of
compressible material such that the upper surface of the cushion can be
compressed
against the outer edge of the nostril to help form a seal with the nostril of
the user.
Ideally, nostril interface tubes 135 are each formed as a single integral
piece which can be
attached and removed from the interface body 105.
[0044] Preferably, the nostril interface elements 135 also include a
lower radial
element 145 which is a radial protrusion adapted to be urged toward the upper
cushion
140 and to compress the upper cushion 140 to aid in forming a seal between the
upper
cushion 140 and a person's nostril when the device 100 is warn by a person. In
certain
embodiments, the lower radial element 145 includes an internal substantially
rigid rim
152 adapted to aid in compressing the upper cushion 140 when the device 100 is
warn by
a person.
[0045] Ideally, the nostril interface elements 135 have substantially
non-porous
surfaces. For example, they may be formed entirely of a non-porous material
such as
silicone or any other suitable material. Alternatively, at least the exposed
surfaces of the
nostril interface elements 135 are coated with a non-porous material such as
silicone, or
any other suitable material. In certain embodiments, the nostril interface
elements 135
are removably attached to the interface body 105, such as via a snap fit,
frictional fit,
threading, or any other suitable method. Thus, they can be removed for
cleaning or
replacement.
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[0046] The device 100 includes a facial patch 150. The facial patch
can be
adhered to the face of a user. Preferably, the facial patch 150 is a nose
cover 150 which
adheres to the nose of a user. The nose cover 150 preferably includes an
adhesive on its
bottom surface to removably adhere to the skin of the user's nose. The
adhesive is
ideally suitable for use on skin and removable. This nose cover 150 is ideally
disposable
and replaceable.
[0047] The nose cover 150 is ideally formed of a flexible material.
Optionally, a
bendable element 155 is included as part of the nose cover 150 which may be
embedded
within it or on one of its surfaces. The bendable element 155 is formed of a
material
which can be bent to fit the contour of the nose and hold its shape so as to
help the nose
cover 150 adhere to the nose. The bendable element may be formed of any
suitable
material, such as a metal as aluminum, or any other material with suitable
properties.
[0048] In various embodiments, in order to hold the device 100 in
place properly,
at least one attachment flap 160, and preferably two attachment flaps 160 are
connected
to the nasal interface body 105. They secure to the surface of the nose cover
150. Any
suitable manner of removable attachment is contemplated. For example, hook and
loop
attachment in which one element of the hook and loop material 165 is attached
to the
flaps 160, and the other element of the hook and loop material 170 is attached
to the
surface of the nose cover 150. However, an adhesive or other manner of
attachment can
be used. Ideally, the flaps 160 extend around the sides of the interface body
105 and hold
the device 100 snug against the nostrils. In this way, no straps around the
head of the
user are required.
[0049] In an alternate embodiment, the nostril interface elements 135
may include
a magnet or iron or nickel bearing material, and they may be secured to the
nose via
magnets on the external surface of the nose. In a further alternate
embodiment, as shown
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in Fig. 8, the nose cover 150 may be eliminated and one or more flaps 160 may
be
adhered directly to the outer surface of the nose of the user.
[0050] While specific embodiments have been illustrated and described,
numerous modifications come to mind without significantly departing from the
spirit of
the invention and the scope of protection is limited by the scope of the
accompanying
claims.
