U.S. patent application number 16/653963 was filed with the patent office on 2020-02-06 for strapless nasal interface device.
The applicant listed for this patent is Venkata Buddharaju. Invention is credited to Venkata Buddharaju.
Application Number | 20200038615 16/653963 |
Document ID | / |
Family ID | 61282335 |
Filed Date | 2020-02-06 |
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United States Patent
Application |
20200038615 |
Kind Code |
A1 |
Buddharaju; Venkata |
February 6, 2020 |
STRAPLESS NASAL INTERFACE DEVICE
Abstract
A nasal interface device is configured to be positioned about a
user's nose. The nasal interface device includes an air supply
interface including first and second attachment surfaces, a
bendable metallic member including a bridge portion between first
and second ends, an adhesive secured to an underside of the
bendable metallic member, a first elastic member, and a second
elastic member. The bridge portion compresses downward over the
nasal bone of the bridge of the user's nose and the bendable
metallic member compresses downward toward the first and second
sides of the user's nose during use. The first and second elastic
members are adjustable in position on the bendable metallic member
and on the air supply interface body. The first and second elastic
members are pulled taut to form a seal where the air supply
interface body meets the user's nose.
Inventors: |
Buddharaju; Venkata; (Park
Ridge, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Buddharaju; Venkata |
Park Ridge |
IL |
US |
|
|
Family ID: |
61282335 |
Appl. No.: |
16/653963 |
Filed: |
October 15, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15905503 |
Feb 26, 2018 |
10441737 |
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16653963 |
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15810061 |
Nov 11, 2017 |
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15905503 |
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15204718 |
Jul 7, 2016 |
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15810061 |
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13864853 |
Apr 17, 2013 |
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15204718 |
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12641094 |
Dec 17, 2009 |
8430098 |
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13864853 |
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14930548 |
Nov 2, 2015 |
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15810061 |
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61138472 |
Dec 17, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0605 20140204;
A61M 16/0875 20130101; A61M 2205/0238 20130101; A61M 16/0057
20130101; A61M 16/0672 20140204; A61M 16/0616 20140204; A61M
16/0666 20130101; A61M 16/0688 20140204; A61M 2016/0661 20130101;
A61M 16/0683 20130101; A61J 15/0053 20130101; A61J 15/0003
20130101 |
International
Class: |
A61M 16/06 20060101
A61M016/06; A61M 16/08 20060101 A61M016/08; A61M 16/00 20060101
A61M016/00; A61J 15/00 20060101 A61J015/00 |
Claims
1. A nasal interface device configured to be positioned about a
nasal hone of a bridge, a first side, and a second side of a user's
nose, comprising: an air supply interface including an air supply
opening, at least one nasal opening, and first and second
attachment surfaces, wherein the nasal device is selected from the
group of a se mask, nostril interface tubes, and nose pillows; a
bendable metallic member including a bridge portion between first
and second ends, wherein the bridge portion compresses downward
over the nasal bone of the bridge of the user's nose and the
bendable metallic member compresses downward toward the first and
second sides of the user's nose; an adhesive secured to an
underside of the bendable metallic member; a first elastic member
having a first proximal end and a first portion, the first proximal
end including a first coupling means for directly or indirectly
attaching to the first end of the bendable metallic element, and
the first portion engaging with the first attachment surface on the
air supply interface body; and a second elastic member having a
second proximal end and a second portion, the second proximal end
including a second coupling means for directly or indirectly
attaching to the second end of the bendable metallic element, and
the second portion engaging with the second attachment surface on
the air supply interface body; wherein the proximal ends of the
first and second elastic members are adjustable in position on the
bendable metallic member; wherein the first and second portions of
the first and second elastic members are adjustable in position on
the air supply interface body; and wherein each of the first and
second elastic members is pulled taut in order to form a seal where
the air supply interface body meets the user's nose without needing
straps extending around the user's head.
2. The nasal interface device of claim 1, wherein the first portion
is a first distal end of the first elastic member, and wherein the
second portion is a second distal end of the second elastic
member.
3. The nasal interface device of claim 1, wherein each of the first
and second elastic members has a length of between about 5 cm and
about 6 cm.
4. The nasal interface device of claim 1, wherein each of the first
and second elastic members comprises a rubber material.
5. The nasal interface device of claim 1, wherein each of the first
and second elastic members comprises a woven elastic band.
6. The nasal interface device of claim 5, wherein each of the first
and second coupling means has a length of at least about 3 cm.
7. The nasal interface device of claim 1, wherein the air supply
interface connects to one of a ventilator, a continuous positive
airway pressure (CPAP) machine, and a bilevel positive airway
pressure (BiPAP) machine.
8. A nasal interface device configured to be positioned about a
nasal hone of a bridge, a first side, and a second side of a user's
nose, comprising: a nose mask including an air supply opening,
wherein the nose mask is positioned about the user's nose; a
bendable metallic member including a bridge portion between first
and second ends, wherein the bridge portion compresses downward
over the nasal bone of the bridge of the user's nose and the
bendable metallic member compresses downward toward the first and
second sides of the user's nose; an adhesive secured to an
underside of the bendable metallic member; wherein the bendable
metallic member is secured to the nose mask.
9. The nasal interface device of claim 8, wherein the nose mask
includes first and second attachment surfaces, and wherein the
first and second ends of the bendable metallic member engage with
the first and second attachment surfaces, respectively, of the nose
mask.
10. The nasal interface device of claim 9, further comprising: a
first elastic member having a first proximal end and a first
portion, the first proximal end including a first coupling means
for directly or indirectly attaching to the first end of the
bendable metallic element, and the first portion engaging with the
first attachment surface on the air supply interface body; and a
second elastic member having a second proximal end and a second
portion, the second proximal end including a second coupling means
for directly or indirectly attaching to the second end of the
bendable metallic element, and the second portion engaging with the
second attachment surface on the air supply interface body; wherein
the proximal ends of the first and second elastic members are
adjustable in position on the bendable metallic member; wherein the
first and second portions of the first and second elastic members
are adjustable in position on the air supply interface body; and
wherein each of the first and second elastic members is pulled taut
in order to form a seal where the air supply interface body meets
the user's nose without needing straps extending around the user's
head.
11. A method of wearing a nasal interface device about a nasal bone
of a bridge, a first side, and a second side of a user's nose,
comprising the steps of: providing the nasal interface device
comprising: an air supply interface including an air supply
opening, at least one nasal opening, and first and second
attachment surfaces, e nasal device is selected from the group of a
nose mask, nostril interface tubes, and nose pillows; a bendable
metallic member including a bridge portion between first and second
ends; an adhesive secured to the underside of the bendable metallic
member; a first elastic member having a first proximal end and a
first portion, the first proximal end including a first coupling
means for directly or indirectly attaching to the first end of the
bendable metallic element, and the first portion engaging with the
first attachment surface on the air supply interface body; and a
second elastic member having a second proximal end and a second
portion, the second proximal end including a second coupling means
for directly or indirectly attaching to the second end of the
bendable metallic element, and the second portion engaging with the
second attachment surface on the air supply interface body; wherein
the proximal ends of the first and second elastic members are
adjustable in position on the bendable metallic member; and wherein
the first and second portions of the first and second elastic
members are adjustable in position on the air interface body;
compressing the bridge portion of the bendable metallic element
downward over the nasal bone of the bridge and toward the first and
second sides of the user's nose; positioning the air supply
interface body about the user's nose, wherein the first and second
attachment surfaces of the air supply interface body are adjacent
to the first and second sides, respectively, of the user's nose;
adjusting the positioning of the proximal ends of the first and
second elastic members on the bendable metallic member; adjusting
the first and second portions of the first and second elastic
members on the air interface body; pulling the first and second
elastic members taut in order to form a seal where the air supply
interface body meets the user's nose; and securing each of the
first and second coupling means to maintain the seal without
needing straps extending around the user's head.
12. The method of claim 11, wherein the first portion is a first
distal end of the first elastic member, and wherein the second
portion is a second distal end of the second elastic member.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority and is a
continuation of U.S. application Ser. No. 15/905,503 filed Feb. 26,
2018, which is a continuation of U.S. application Ser. No.
15/810,061 filed Nov. 11, 2017, which is a continuation-in-part of
U.S. application Ser. No. 15/204,718, filed Jul. 7, 2016, which is
a continuation-in-part of U.S. application Ser. No. 13/864,853,
filed Apr. 17, 2013, which is a continuation of U.S. application
Ser. No. 12/641,094 filed Dec. 17, 2009, which claims the benefit
of priority to U.S. Provisional Application No. 61/138,472 filed on
Dec. 17, 2008. U.S. application Ser. No. 15/810,061 filed Nov. 11,
2017 is also a continuation-in-part of U.S. application Ser. No.
14/930,548 filed Nov. 2, 2011. The disclosures of each
above-mentioned application are incorporated by reference
herein.
FIELD OF THE INVENTION
[0002] The present invention relates to a straplessnasal interface
device, and more particularly, to a device for use with an air
supply, a ventilator, a continuous positive airway pressure (CPAP)
machine, or a bilevel positive airway pressure (BiPAP) machine for
strapless interface with the nasal passages.
BACKGROUND OF THE INVENTION
[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 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 specifically along the bridge portion of the nose as well as
areas of the head in contact with the straps, and can deter use of
the device. The user often needs to adjust the straps during the
night, and movement of the nasal device often results in leakage.
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. Pat. 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. Pat. 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 require 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. Pat. 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. Pat. No. 7,000,613,
issued to Wood et al. In this patent, an interface device also has
tubes which extend into the nasal 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 5 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] U.S. Published Patent Application No. 2010/0000534 by Kooij
et al. discloses various nasal interface systems that are secured
to the head of the user by connector strips and an adhesive strip.
A body of the nasal interface system is positioned about the user's
nostrils. The adhesive strip is secured to the bridge of the user's
nose and includes Velcro portions on the outer surface that engage
with first and second connector strips extending from opposite
sides of the body at the user's nostrils. The adhesive strip is a
separate component.
[0012] In U.S. Pat. No. 5,735,272 issued to Dillon et al., a nasal
tube holder for anchoring a nasal tube in a nasal passage is
disclosed. The nasal tube holder includes a nasal dilator that is
affixed to the bridge of the user's nose. Metallic or plastic truss
members on the nasal dilator extend across the bridge of the nose,
flexing the nasal dilator into a planar position so as to open up
the user's nasal passages.
[0013] 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.
[0014] 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.
SUMMARY OF THE DISCLOSURE
[0015] The present invention provides, in one aspect, 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.
Children in particular are sensitive to the discomfort of nasal
devices and claustrophobic experiences. 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.
[0016] In one aspect of the invention, the nasal interface device
configured to be positioned about a user's nose, includes an air
supply interface connected to an air tube and a bendable element
connected to the air supply interface. The bendable element bends
to match contours of the user's nose and holds its shape so as to
secure a position of the air supply interface relative to the
user's nose. The bendable element may be made of a metallic
material, such as aluminum. One or more adhesives may be positioned
along the band element to promote adherence to the user's face. The
adaptability of the bendable element to conform to the shape of the
user's nose allows for the bendable element to be used with a
variety of shapes and sizes of noses, including the noses of small
children as well as adults.
[0017] In traditional nasal interface devices, the fulcrum of force
that holds the nasal device to the user's face is centered in the
back of the head through the use of straps. In the nasal interface
devices of the present application, the fulcrum of force is
centralized on the bridge of the nose through the use of the
bendable element. This repositioning relieves the user of stresses
and discomfort related to the straps and minimizes the affected
area from the whole head (by means of the straps) to the nasal area
(through a nose mask and/or nostril interface tubes).
[0018] In one embodiment, 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 may also include exhalation holes. Thus,
when the user exhales, the carbon dioxide rich exhalation air can
exit through the exhalation holes, allowing new air to enter. In
other devices, the nasal interface device may be used to position a
cannula that is connected to an oxygen tank so that the nasal
prongs of the cannula are at the user's nostrils. In a further
embodiment, the nasal interface device may be used to maintain the
positioning of a feeding tube at the user's nostrils.
[0019] The bendable element may be a flexible strip of material
with a first bend corresponding to contours of a bridge area of the
user's nose. As used throughout the present application, the
bridge, also referred to as the bridge area, includes the bridge of
the user's nose and an area adjacent to the bridge, including at
least about 2 mm, and preferably about 4 mm, below the bridge of
the user's nose. The bendable element may also include first and
second side portions between the first bend and first and second
ends, respectively, wherein the first and second side portions
correspond to contours of sides of the user's nose. The bendable
element may also include second and third bends, where the first
and second side portions are between the first bend and the second
and third bends, respectively. The bendable element may also
include fourth and fifth bends adjacent to the first and second
ends, respectively.
[0020] In yet another aspect, a breathing interface device includes
a housing or air supply interface defining a chamber. The housing
includes a first nostril tube in fluid communication with the
chamber, a second nostril tube in fluid communication with the
chamber, and a first opening in fluid communication with the
chamber and a positive pressure source. The breathing interface
device further includes a facial patch adherable to a portion of a
user's face and has a contact surface, and an attachment flap
rotatably couplable to the housing and releasably couplable to the
facial patch. The bendable element may be secured to an underside
of the facial patch. In some embodiments, the facial patch is a
nose mask. The bendable element may be positioned along an outer
edge of the nose mask.
[0021] In some embodiments, the height of the bendable element (the
distance between the first bend of the bendable element and the air
supply interface) may be adjusted to accommodate for various sizes
and shapes of users' noses, from pediatric patients to adult sizes.
The bendable element is connected to the air supply interface near
the first and second ends, and the user may modify the height of
the bendable element by moving the first and second ends further or
closer to the air supply interface. In one embodiment, the air
supply interface may include first and second side slots through
which the first and second ends of the bendable element extend. The
user can pull or push the bendable element so that the user can
move the first and second ends of the bendable element closer to or
away from the first and second side slots, respectively.
[0022] So that the height and positioning of the bendable element
about the user's face may be adjusted for various sizes and shapes
of user's noses. Alternatively, an adjusting device may be secured
to the air supply interface that includes first and second
adjusters that engage with the bendable element near the first and
second ends, respectively. Rotation of the first and second
adjusters allow the user to adjust the height and positioning of
the bendable element about the user's face.
[0023] In some embodiments, the housing or air supply interface
includes a body that interfaces with the user's 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 along with the bendable element that bends to match
contours of the user's nose and holds its shape so as to secure a
position of the air supply interface relative to the user's nose,
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 sensitive nasal mucosa.
Alternatively, the nostril interface elements are held against the
outer edge of the nostrils.
[0024] 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.
[0025] 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.
[0026] 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.
[0027] 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.
[0028] 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. Side flaps are optionally included extending
from the sides of the body of the device. An optional front flap
may also 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.
[0029] 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.
[0030] In a further embodiment, the nasal interface device
configured to be positioned about a user's nose includes a bendable
element including a bridge portion that corresponds to a bridge of
the user's nose and first and second ends. The bendable element
forms first and second platforms adjacent to the first and second
ends. The nasal interface device further includes an adhesive
secured to an underside of the bendable element. The bendable
element bends to match contours of the user's nose and holds its
shape so as to secure a position of the air supply interface
relative to the user's nose.
[0031] In another aspect of the embodiment, the first and second
platforms of the bendable element may support first and second
lanyards of a cannula and/or a feeding tube. In further
embodiments, each of the first and second ends of the bendable
element include one of a protrusion, a button, and a clasp that
attaches to first and second sides, respectively, of the bendable
element.
[0032] In yet another embodiment, the nasal interface device may be
positioned onto a pair of glasses to maintain the positioning of a
cannula and/or a feeding tube relative to the user's nostrils. The
bridge portion of the bendable element may be received by the pad
arms carrying the nose pads of the glasses.
[0033] 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, 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] FIG. 1 shows an embodiment of the nasal interface device of
the present application.
[0035] FIG. 2 shows another embodiment of the nasal interface
device of the present application, having optional side and front
straps for mounting the device.
[0036] FIG. 3 shows an embodiment of FIG. 2 as mounted on a user's
nose.
[0037] FIG. 4 shows an embodiment of the nasal interface element
used in the embodiments of the nasal interface devices of FIGS. 1
and 2.
[0038] FIG. 5 shows another embodiment of the nasal interface
device of the present application.
[0039] FIG. 6 shows an exploded view of the embodiment of FIG.
5.
[0040] FIG. 7 shows a perspective view of a further embodiment of
the nasal interface device of the present application.
[0041] FIG. 8 shows another embodiment of the nasal interface
device of the present application.
[0042] FIG. 9 is a perspective view of a further embodiment of the
nasal interface device of the present application.
[0043] FIG. 10 is a front elevational view of the nasal interface
device of FIG. 9.
[0044] FIG. 11 is a rear elevational view of the nasal interface
device of FIG. 9.
[0045] FIG. 11A is a cross-sectional view generally taken along
lines 11A-11A shown in FIG. 11.
[0046] FIG. 12 is a front elevational view of a bendable element
used in the nasal interface device of FIG. 9.
[0047] FIG. 13A is a perspective view of an alternative air supply
interface for use with any of the illustrated embodiments.
[0048] FIG. 13B is a front elevational view of the alternative air
supply interface of FIG. 13A.
[0049] FIG. 14A is a further embodiment of the nasal interface
device of the present application including a nose mask.
[0050] FIGS. 14B and 14C are further embodiments of the nasal
interface device of the present application including a nose and
mouth mask.
[0051] FIG. 15 is a further embodiment of the nasal interface
device of the present application adapted for use with a
cannula.
[0052] FIG. 16 is a further embodiment of the nasal interface
device of the present application for use with a feeding tube.
[0053] FIG. 17 is a further embodiment of the nasal interface
device of the present application adapted for use with a
cannula.
[0054] FIG. 18 is a perspective view of another embodiment of the
nasal interface device of the present application.
[0055] FIG. 19 is a front elevational view of the nasal interface
device of FIG. 18.
[0056] FIG. 20 is a rear elevational view of the nasal interface
device of FIG. 18
[0057] FIG. 21 is a perspective view of a further embodiment of the
nasal interface device of the present application.
[0058] FIG. 22 is a front elevational view of the nasal interface
device of FIG. 21.
[0059] FIG. 23 is a perspective view of a further embodiment of the
nasal interface device of the present application.
[0060] FIG. 24 is a front elevational view of the nasal interface
device of FIG. 23.
[0061] FIG. 25 is a perspective view of a further embodiment of the
nasal interface device of the present application.
[0062] FIG. 26 is a front elevational view of the nasal interface
device of FIG. 25.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0063] 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.
[0064] 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.
[0065] The device 10 further includes at least one nostril
interface tube 50 extending from the body 20 to interface with the
nasal passages of a user or a person. 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.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] 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 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.
[0070] 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 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.
[0071] 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.
[0072] 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 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.
[0073] 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.
[0074] 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 of the user without compromising the integrity
of the seal formed between the device and the user's nostrils.
[0075] 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.
[0076] 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 user's nostril when the device 100 is worn by a user. 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 worn by a user.
[0077] 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.
[0078] 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.
[0079] 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.
[0080] In the embodiment illustrated in FIGS. 5 and 6, one or two
attachment flaps 160 are connected to the nasal interface body 105
to hold the device 100 in place properly. 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.
[0081] 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 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.
[0082] FIGS. 9-12 illustrate a further embodiment of a strapless
nasal interface device 300 suitable for use with a CPAP or BIPAP
device, or with any other ventilator type device. The device 300
includes an air supply interface 302 defining an interior cavity or
chamber 304, an intermediate air tube 306, and an air supply tube
310 extending therefrom.
[0083] The device 300 includes one or two nostril interface tubes
312 extending from a body 313 of the air supply interface 302 to
engage with the nasal passages of the user as described with
respect to previous embodiments. Referring to FIG. 10, compressible
expandable nasal interface elements 314 surround the tubes 312 and
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 312 in place within the nostril. Each of
the interface tubes 312 may also include a skirt (see FIG. 1) to
aid in sealing the air passage.
[0084] Seen best in FIGS. 10 and 11, a bendable element 316 is
secured to the air supply interface 302 and is sufficiently
flexible so that its shape corresponds to contours of the user's
face as seen in FIG. 9. First and second ends 318, 320 of the
bendable element 316 engage with first and second slots 322, 324 on
the interface body 313 to hold the air supply interface 302 in
position relative to the user's nose as the bendable element 316 is
secured to the user's face.
[0085] The bendable element 316 illustrated in FIG. 12 is a
metallic strip including bends that correspond to contours of the
user's nose and face. The plasticity of the material of the
bendable element 316 is deformable so that it bends to match
contours of the user's nose while maintaining its shape so as to
secure the positioning of the air supply interface 302 relative to
the user's nose. The material of the bendable element 316 may be
aluminum or other suitable material.
[0086] A first bend 326 of the bendable element 316 corresponds to
the bridge area of a user's nose. Second and third bends 328, 330
define first and second side portions 336, 338, respectively, of
the bendable element 316 that are seated against the sides of the
user's nose. Fourth and fifth bends 332, 334 adjacent to first and
second ends 318, 320 of the bendable element 316 engage the body
313 of the air supply interface 302. While the illustrated
embodiment includes five bends, the bendable element 316 may be
free from bends yet be shaped to conform to the user's face, or may
include any number of bends necessary to conform to the user's face
and/or to engage the air supply interface 302.
[0087] In the embodiment illustrated in FIG. 9, the first and
second ends 318, 320 of the bendable element 316 are threaded
through the first and second slots 322, 324 on the interface body
313 and moveable so that the position of the bendable element 316
can be adjusted for varying sizes and heights of users' noses. As
shown in FIG. 12, the first and second ends 318, 320 may include
protrusions that are received by openings in the first and second
side portions 336, 338, although other suitable fasteners such as,
but not limited to, buttons and/or clasps for securing the first
and second ends 318, 320 to first and second side portions 336, 338
of the bendable element 316 may be used. During use, the user can
adjust the height of the bendable element 316 so that it is
positioned comfortably and appropriately on the user's nose while
the air supply interface 302 is positioned at the user's
nostrils.
[0088] Referring to an alternative embodiment illustrated in FIGS.
18-20, a strapless nasal interface device 700 secures a bendable
element 702 to the bridge area 703 of the user's nose using first
and second elastic members 704, 706. First ends of the first and
second elastic members 704, 706 are secured to first and second
ends 708, 710, respectively, of the bendable element 702. In the
illustrated embodiment, the first and second elastic members 704,
706 are threaded through first and second slots 712, 714,
respectively, within the interface body 716. In other embodiments,
the first and second elastic members 704, 706 may be attached to
the sides of interface body 716 by any suitable means, such as, for
example, through a slotted surface on the interface body 716 or any
other attachment means as described with respect to other
embodiments of the present application.
[0089] In a preferred embodiment, each elastic member 704, 706 is a
rubber or other suitable material having a minimum Young's modulus
of 0.01 to 0.1 GPa. In some embodiments, each elastic member 704,
706 may have a length of about 3 cm to about 4 cm and a width of
about 1 cm to 1.5 cm.
[0090] At second ends of the first and second elastic members 704,
706, first and second adhesive members 718, 720 adhere to first and
second sides 722, 724 of the user's nose. Each adhesive member 718,
720 may comprise an elastic surgical tape material. One example
material is a foam adhesive tape that conforms easily to facial
features such as 3M Microfoam (St. Paul, Minn.). In some
embodiments, each adhesive member 718, 720 may have a length of
about 3 cm to about 6 cm and a width of about 1 cm to 1.5 cm.
[0091] During use, the user first inserts the interface body 716
and/or nose pillows adjacent to the nose or nostrils. The user then
adjusts the positioning of each elastic member 704, 706 within the
respective slot 712, 714 so that each adhesive member 718, 720 is
positioned on the side 722, 724 of the nose and is taut between
first and second ends 708, 710, respectively, of the bendable
element 702 and the adhesive members 718, 720. In the embodiment
illustrated in FIG. 18, the first and second adhesive members 718,
720 cross the user's nose and are secured to the opposite sides 724
and 722, respectively. In other embodiments, the first and second
adhesive members 718, 720 are secured to the adjacent sides 722 and
724. Due to the stretching of the elastic members 704, 706 and the
adhesive members 718, 720, the interface body 716 fits snug against
the user's nose without the need for straps extending around the
head or extending along the cheeks of the user. The lack of straps
and additional attachment means provides a more comfortable sleep
for the user due to the elimination of the straps as well as the
minimization of the unit altogether. Further, the combination of
the elastic members 704, 706 in conjunction with the metallic
bendable element 702 secure the seal of the interface body 716 at
the user's nose and maintains the interface body 716 in close
proximity to the nostrils. Simultaneously, the elastic members 704,
706 and the bendable element 702 allow the user to conform and
adjust the device about the user's face and as necessary to
maintain the seal.
[0092] FIGS. 21 and 22 illustrate a strapless nasal interface
device 800 including a bendable element 802 secured to the
interface body 803 via first and second elastic members 804, 806.
In this embodiment, first and second elastic members 804, 806 are
positioned such that first ends 808, 810 are adjacent to first and
second slotted surfaces 812, 814, respectively, of the interface
body 803. In other embodiments, the first and second elastic
members 804, 806 may extend through first and second slot within
the interface body 803, or the first and second elastic members
804, 806 may attach to the interface body 803 through any other
suitable attachment means, particularly as described with respect
to other embodiments of the present application.
[0093] Second ends 816, 818 of the first and second elastic members
804, 806 are threaded through first and second rings 820, 822,
respectively, that are secured to the first and second ends 824,
826, respectively, of the bendable element 802. The first and
second ends 824, 826 of the bendable element 802 may be bent in a
folding fashion to provide a hooking surface to receive the first
and second rings 820, 822, respectively. Other connection means may
also be used.
[0094] In one embodiment, each of the first and second elastic
members 804, 806 include a first hook and loop fastener surface
828, 830 on at least one side of each first and second elastic
members 804, 806 adjacent to the interface body 803 and a second
hook and loop fastener surface 832, 834 on second ends 816, 818 of
the first and second elastic members 804, 806. During use, the
first and second elastic members 804, 806 are taut between the
first and second slots 812, 814 of the interface body 803 and the
second hook and loop fastener surface 832, 834 of the first and
second elastic members 804, 806.
[0095] Similar to the device described above, the combination of
the elastic members 804, 806 in conjunction with the metallic
bendable element 802 secure the seal of the interface body 803 at
the user's nose and maintains the interface body 803 in close
proximity to the nostrils. Simultaneously, the elastic members 804,
806 and the bendable element 802 allow the user to conform and
adjust the device 800 about the user's face and as necessary to
maintain the seal. In some embodiments, the strapless nasal
interface device 800 delivers pressures between about 4 and about
20 cmH.sub.2O.
[0096] In a still further embodiment illustrated in FIGS. 23 and
24, a strapless nasal interface device 900 is secured to the user's
nose by first and second elastic members 902, 904 and corresponding
adhesive members 906, 908. More specifically, the first and second
elastic members 902, 904 extend through first and second slots 914,
916, respectively, of the interface body 918, although any suitable
attachment means may be used. In the illustrated embodiment, the
first and second slots 914, 916 are sufficiently narrow so as to
secure first ends 910, 912 of the first and second elastic members
902, 904 in place.
[0097] First and second adhesive members 906, 908 are attached to
second ends 920, 922 of the first and second elastic members 902,
904, respectively. Referring to FIG. 24, each elastic member 902,
904 is secured to the respective adhesive member 906, 908 by a ring
924, 926 or other suitable securing mechanism. The adhesive member
906, 908 may comprise an elastic surgical tape material. One
example material is a foam adhesive tape that conforms easily to
facial features such as 3M Microfoam (St. Paul, Minn.).
[0098] During use, the user first inserts the interface body 918
and/or nose pillows adjacent to the nose or nostrils. The user then
adjusts the positioning of each elastic member 902, 904 within the
slot 914, 916 to position each adhesive member 906, 908 on the side
of the nose so that each elastic member 902, 904 is taut between
the slot 914, 916 and the adhesive member 906, 908. In the
embodiment illustrated in FIG. 23, the user adheres the first
adhesive member 906 to the bridge area of the user's nose, and then
adheres the second adhesive member 908 to the bridge area of the
user's nose overlapping with the first adhesive member 906. In
other embodiments, the interface device 900 may be used to position
a cannula that is connected to an oxygen tank so that the nasal
prongs of the cannula are at the user's nostrils. In a further
embodiment, the nasal interface device may be used to maintain the
positioning of a feeding tube at the user's nostrils. Any of the
nasal devices described herein may be in fluid communication with a
ventilator, a continuous positive airway pressure (CPAP) machine,
and a bilevel positive airway pressure (BiPAP) machine.
[0099] Similar to the embodiments mentioned above, the stretching
of the elastic members 902, 904 and the adhesive members 906, 908
allows the interface body 918 to fit snugly against the user's nose
without the need for straps extending around the head or extending
along the cheeks of the user. The lack of straps and additional
attachment means provides a more comfortable sleep for the user due
to the elimination of the straps as well as the minimization of the
unit altogether.
[0100] A mild adhesive may be applied to the underside of the
bendable element 316 to hold it in place against the user's face.
Such adhesive must be mild enough that the element can be easily
removed by the user without causing significant discomfort or
irritation or abrasion. The adhesive may also be a soft foam or
non-foam (such as a silicone) adhesive. Further, the adhesive may
include a slit so that it can slide onto the bendable element
316.
[0101] In a still further embodiment illustrated in FIGS. 25 and
26, a strapless nasal interface device 1000 is secured to the
user's nose by first and second elastic members 1002, 1004. The
first and second elastic members 1002, 1004 extend between an air
supply interface 1016 at the user's nostrils and a metallic
bendable element 1003 across the bridge of the user's nose. In this
embodiment, the elastic members 1002, 1004 are adjustable with
respect to both the air supply interface 1016 and the metallic
bendable element 1003. Each elastic member 1002, 1004 includes a
series of openings 1020 along the length thereof. The air supply
interface 1016 includes side tabs 1022, 1024 having protrusions or
buttons 1026, 1028 thereon, which engage with an opening 1020 at a
lower end 1002a, 1004a in the respective elastic member 1002, 1004.
The metallic bendable element 1003 also includes opposing
attachment surfaces 1030, 1032 that each engage with an opening
1020 at an upper ends 1002b, 1004b of the respective elastic member
1002, 1004. The attachment surfaces 1030, 1032 include a rigid
structure that curves upward, although any suitable structure such
as a button, protrusion, or other securement means may be used.
Through the use of the openings 1020, the elastic member 1002, 1004
is adjustable at both of its lower and upper ends 1002a,b, 1004a,
b, providing greater flexibility to the patient when attempting to
secure the device 1000 in place.
[0102] In some embodiments, the elastic member 1002, 1004 engages
with the side tabs 1022, 1024 of the air supply interface 1016
through any suitable coupling means which allows for adjustability.
Similarly, the elastic member 1002, 1004 engages with the side
structures 1030, 1032 of the metallic bendable element 1003 through
any suitable coupling means which allows for adjustability.
[0103] The embodiment illustrated in FIGS. 25 and 26 also features
a torsion shaped air supply interface 1016, although the elastic
member structure 1002, 1004 described herein may be used with any
nasal mask, nostril interface, donut-shaped nasal aperture with
soft, stretchable margins or other suitable structure, including
but not limited to other embodiments shown herein. In some
embodiments, the margins surrounding the nose mask, the
donut-shaped nasal aperture, or similar device may include an
adhesive, such as (but not limited to) a mild, washable, reusable
adhesive, to improve the seal between the air interface body and
the face.
[0104] In the embodiment illustrated in FIGS. 9-12, the adhesive
346 is positioned along the underside of the bendable element 316
to adhere to the user's skin, primarily along the first bend 326 of
the bendable element 316. Second and third adhesives 348, 350 may
optionally be positioned along the bendable element 316 between the
second and third bends 328, 330 and the fourth and fifth bends 332,
334, respectively. In the illustrated embodiment, an inner surface
316a of the bendable element 316 includes first and second grooves
316b, 316c that receive the adhesive 346 as shown in FIG. 11A. Each
groove 316b, 316c is formed by first and second ledges 316d, 316e
extending from first and second outer edges 316f, 316g of the
bendable element 316. The adhesive 346 includes an outer adhesive
surface 346a spaced apart from an inner non-adhesive surface 346b
by a body 346c. The inner surface 346b is positioned within the
first and second grooves 316b, 316c, and the outer surface 346a is
positioned outwardly of the grooves 316b, 316c. The sizes, shapes,
and dimensions of the grooves 316b, 316c of the bendable element
316 and surfaces 346a, 346c and body 346b of the adhesive 346 may
vary from those shown in the illustrated embodiment of FIG. 11A as
desired or necessary. The grooves 316b, 316c may be formed along
the length of the bendable element 316 or at discrete portions of
the bendable element 316.
[0105] In an alternative embodiment, a single adhesive may be
applied that extends between the first and second side portions
336, 338, optionally including the second and third bends, 328,
330, across the first bend 326. The adhesives 346, 348, 350 may be
reused a number of times (rewetting with water as necessary), and
easily replaced as necessary. Another suitable adhesive is a
polyolefin foam tape for dermatological use, such as 3M.RTM.
CoTran.TM. 9773 Tape. In other embodiments, any number of adhesives
may be used as necessary to sufficiently secure the bendable
element 316 to the user's face. In an alternative embodiment, first
and second edges of the adhesive 346 may be pre-coiled so that they
can be easily received by the first and second grooves 316b, 316c
of the bendable element 316. The adhesive stability improves as the
bendable element 316 is bent because such bending improves the
retention of the adhesive 346 within the grooves 316b, 316c. In
another embodiment shown in FIG. 13B, the adhesive 346d has a
tubular shape that is threaded onto the bendable element 316. The
outer surface of the adhesive 346d may be completely adhesive or
may include adhesive and non-adhesive portions. For example, the
tubular adhesive 346d may include an inner adhesive portion along
the inner surface of the bendable element and an outer non-adhesive
portion along the outer surface of the bendable element.
[0106] In a further embodiment illustrated in FIGS. 13A and 13B,
the air supply interface 302 includes an adjusting device 340 to
modify the height and position of the bendable element 316 relative
to the air supply interface. The adjusting device includes a
bendable element base 342 that is received by an adjustment dial
344. The adjustment dial is threaded onto a tubing connector 346.
The first and second ends 318, 320 of the bendable element 316 are
secured to or integral with the bendable element base 342 so that
rotation of the adjustment dial 344 along the tubing connector 346
causes the first and second ends 318, 320 to move vertically,
thereby causing the bendable element 316 to adjust for varying
sizes and heights of users' noses.
[0107] FIGS. 14A-14C illustrate further embodiments of the
strapless nasal interface device 400 that is similar to the
strapless nasal interface device 300 except for the features
described as follows. The primary difference is the use of a nose
mask 402 in lieu of the nostril interface tubes 312. As shown in
FIGS. 14A-14C, the nose mask 402 is connected to an air supply
interface 404. In FIG. 14A, the nose mask 402 covers the nose of
the user. In FIGS. 14B and 14C, each of the nose masks 402a and
402b covers the mouth in addition to the nose. In FIGS. 14A and
14B, the bendable element 406, 406b is positioned outside of the
nose mask 402, 402a, while in FIG. 14C, the bendable element 406c
is positioned along the underside of the nose mask 402 at an outer
edge 408. Each of the nose masks 402, 402a of FIGS. 14A and 14B
include a handle 408, 408a through which an end of the bendable
element 406, 406a is threaded and wrapped around in order to secure
the positioning of the bendable element 406, 406a relative to the
nose mask 402, 402a. The bendable element 406b shown in FIG. 14B
extends along the bottom of the nose mask 402a and is threaded
through a second handle 410a to secure positioning as well. Other
manners of securing the bendable element to the nose mask are
envisioned.
[0108] The nose mask 402 is shaped in such a manner to form a seal
or snug fit with the face of the user. The nose mask 402 may have
curved edges around the opening at the nasal air interface to
improve the seal around the nose. The edges may be made of medical
grade silicone. In some embodiments, the outer margins of the nose
mask may include an adhesive to promote the sealing of the nose
mask onto the user's face. Air flows from a body 410 of the air
supply interface 404 into the nose mask 402 and is inhaled by the
user. Similar to the bendable element 316 of the nasal interface
device 300, the bendable element 406 is a metallic strip that
corresponds to contours of the user's nose and face. The plasticity
of the material of the bendable element 406 is deformable so that
it bends to match contours of the user's nose while maintaining its
shape so as to secure the positioning of the air supply interface
404 relative to the user's nose. The height of the bendable element
406 may be adjusted for various sizes and shapes of users' noses.
The strapless nasal interface device 400 may be modified to include
first and second elastic members as described with respect to FIGS.
18-26.
[0109] Referring to FIG. 15, a further embodiment of the strapless
nasal interface device 500 includes a bendable element 502 that
engages with an air supply interface 504. In this embodiment, the
air supply interface 504 is a cannula 506 including a pair of nasal
prongs 508 and first and second lanyards 510, 512 extending from
either side of the nasal prongs 508.
[0110] Similar to the bendable elements 316, 406 of the nasal
interface devices 300, 400, respectively, of FIGS. 9 and 14,
respectively, the bendable element 502 is a metallic strip that
corresponds to contours of the user's nose and face. The plasticity
of the material of the bendable element 502 is deformable so that
it bends to match contours of the user's nose while maintaining its
shape so as to secure the positioning of the cannula relative to
the user's nose.
[0111] The bendable element 502 includes first and second ends 514,
516 and first and second bends 518, 520 adjacent the bridge area of
the user's nose during use. The curvature of the bendable element
502 near the first and second ends 514, 516 provides first and
second platforms or shelves 522, 524, respectively, that engage the
first and second lanyards 510, 512 of the cannula 506. In other
embodiments, the bendable element 502 may be free of bends or may
include any number of bends as desired to facilitate corresponding
to contours of the user's nose.
[0112] Referring to FIG. 15, the first and second lanyards 510, 512
are positioned on the first and second platforms 522, 524 of the
bendable element 502 to assist in positioning the nasal prongs 508
of the cannula 506 adjacent to or within the user's nostrils. As
shown in FIG. 16, the nasal interface device 500 may be used to
maintain the position of a feeding tube 534 relative to the user's
nostrils. Specifically, the first and second platforms 522, 524 of
the bendable element 502 support and maintain the position of the
feeding tube 534 adjacent to or within the user's nostrils.
[0113] In the embodiment illustrated in FIG. 15, protrusions 526
extending from the first and second ends 514, 516 engage with
openings 528 along first and second side portions 530, 532 of the
bendable element 502 so that the user can adjust the sizing and
shape of the platforms 522, 524. The device 500 may include other
suitable fasteners such as, but not limited to, buttons and/or
clasps for securing the first and second ends to first and second
side portions of the bendable element.
[0114] FIG. 17 illustrates an embodiment of the strapless nasal
interface device 600 that is similar to the device 500 of FIG. 15
in that it includes a bendable element 602 that engages with an air
supply interface 604 comprising a cannula 606. The bendable element
602 is shaped to form first and second platforms 608, 610 adjacent
first and second ends 612, 614, respectively, for supporting first
and second lanyards 616, 618 of the cannula 606. In the illustrated
embodiment, the first and second ends 612, 614 remain free from
first and second side portions 620, 622 of the bendable element
602.
[0115] The strapless nasal interface device 600 may be secured to a
pair of glasses 624 that has first and second pad arms 626, 628
that carry first and second nose pads (not shown), respectively,
adjacent first and second frames 634, 636, respectively.
Specifically, the bendable element 602 includes a bridge portion
638 between the first and second side portions 620, 622. First and
second ends 640, 642 of the bridge portion 638 may be held between
the first and second pad arms 626, 628, respectively, and the first
and second frames 634, 636, respectively.
[0116] While the above describes example embodiments of the present
disclosure, these descriptions should not be viewed in a limiting
sense. Rather, several variations and modifications can be made
without departing from the scope of the present disclosure.
* * * * *