U.S. patent application number 14/483960 was filed with the patent office on 2015-03-19 for ventilation interface.
This patent application is currently assigned to RespCare, Inc.. The applicant listed for this patent is RespCare, Inc.. Invention is credited to Louis Javier Collazo, Shara Hernandez.
Application Number | 20150075530 14/483960 |
Document ID | / |
Family ID | 38668058 |
Filed Date | 2015-03-19 |
United States Patent
Application |
20150075530 |
Kind Code |
A1 |
Collazo; Louis Javier ; et
al. |
March 19, 2015 |
VENTILATION INTERFACE
Abstract
A respiration assist mask having an input gas feed tube, a
ventilation interface, a facial interface and nasal inserts. The
gas feed tube can connect to the ventilation interface and form a
seal. The ventilation interface may be joined with the facial
interface to form a seal between the ventilation interface and the
facial interface, as well as between the facial interface and the
face of a user. Additionally, nasal inserts may be inserted into a
portion of the facial interface and form a seal between the inserts
and the facial interface.
Inventors: |
Collazo; Louis Javier;
(Pompano Beach, FL) ; Hernandez; Shara; (Coconut
Creek, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RespCare, Inc. |
Coconut Creek |
FL |
US |
|
|
Assignee: |
RespCare, Inc.
Coconut Creek
FL
|
Family ID: |
38668058 |
Appl. No.: |
14/483960 |
Filed: |
September 11, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11430902 |
May 10, 2006 |
8887725 |
|
|
14483960 |
|
|
|
|
Current U.S.
Class: |
128/205.25 |
Current CPC
Class: |
A61M 2210/0618 20130101;
A61M 16/0622 20140204; A61M 16/0611 20140204; A61M 16/0666
20130101; A61M 16/20 20130101; A61M 2210/0625 20130101; A61M 16/06
20130101; A61M 16/0694 20140204; A61M 16/0816 20130101 |
Class at
Publication: |
128/205.25 |
International
Class: |
A61M 16/06 20060101
A61M016/06; A61M 16/08 20060101 A61M016/08; A61M 16/20 20060101
A61M016/20 |
Claims
1. A ventilation device, comprising: a ventilation interface
adapted to connect to a gas source supplying a gas to the
ventilation interface; a cushioned facial interface coupled with
the ventilation interface, the cushioned facial interface having a
gas exit configured to seal over the mouth of a user, and at least
one nasal opening; at least one removable nasal pillow with at
least one receiving flange; and the cushioned facial interface
having at least three flanges proximate the at least one nasal
opening, at least two of the flanges are used to receive the at
least one receiving flange to couple the cushioned facial interface
to the at least one removable nasal pillow.
2. The ventilation device of claim 1, wherein the at least one
nasal pillow is coupled to a second removable nasal pillow with a
connecting member.
3. The ventilation device of claim 1, wherein the cushioned facial
interface has a membrane with a top edge and the at least one nasal
pillow has a nasal insert portion with a bottom edge, and the
distance between the top edge of the membrane and the bottom edge
of the nasal insert portion that is approximately 0.030'' to
2''.
4. The ventilation device of claim 1, wherein the cushioned facial
interface has two grooves between the at least three flanges.
5. The ventilation device of claim 4, wherein the height of the two
grooves is substantially the same.
6. The ventilation device of claim 1, wherein the at least one
removable nasal pillow is a first removable nasal pillow and a
second removable nasal pillow, wherein the first removable nasal
pillow may couple with the cushioned facial interface at a first
height and the second removable nasal pillow may couple with the
cushioned facial interface at a second height.
7. A ventilation device, comprising: a ventilation interface
adapted to connect to a gas source supplying a gas to the
ventilation interface; a cushioned facial interface coupled with
the ventilation interface, the cushioned facial interface having a
gas exit configured to seal over the mouth of a user and having at
least two receiving flanges at a receiving hole; and at least one
removable nasal pillow, the at least one removable nasal pillow
having at least two flanges with at least one groove formed between
the at least two flanges, wherein the at least one groove receives
at least one receiving flange to couple the at least one removable
pillow with the cushioned facial interface.
8. The ventilation device of claim 7, wherein the at least one
nasal pillow is coupled to a second removable nasal pillow with a
connecting member.
9. The ventilation device of claim 7, wherein the cushioned facial
interface has a membrane with a top edge and the at least one nasal
pillow has a nasal insert portion with a bottom edge, and the
distance between the top edge of the membrane and the bottom edge
of the nasal insert portion that is approximately 0.030'' to
2''.
10. The ventilation device of claim 7, wherein the cushioned facial
interface has a groove between the at least two receiving
flanges.
11. The ventilation device of claim 7, wherein the height of the at
least two receiving flanges of the cushioned facial interface is
substantially the same.
12. The ventilation device of claim 7, wherein the height of the at
least two flanges of the at least one removable nasal pillow is
substantially the same.
13. The ventilation device of claim 7, wherein the at least one
removable nasal pillow is a first removable nasal pillow and a
second removable nasal pillow, wherein the first removable nasal
pillow may couple with the cushioned facial interface at a first
height and the second removable nasal pillow may couple with the
cushioned facial interface at a second height.
14. A ventilation device, comprising: a ventilation interface
adapted to connect to a gas source supplying a gas to the
ventilation interface; a cushioned facial interface coupled with
the ventilation interface, the cushioned facial interface having a
gas exit configured to seal over the mouth of a user; at least one
removable nasal pillow having at least two receiving flanges; and
the cushioned facial interface having a receiving hole with at
least two flanges and one groove formed between the two flanges ,
wherein the groove receives at least one receiving flange to couple
with the at least one removable nasal pillow.
15. The ventilation device of claim 14, wherein the at least one
nasal pillow is coupled to a second removable nasal pillow with a
connecting member.
16. The ventilation device of claim 14, wherein the cushioned
facial interface has a membrane with a top edge and the at least
one nasal pillow has a nasal insert portion with a bottom edge, and
the distance between the top edge of the membrane and the bottom
edge of the nasal insert portion that is approximately 0.030'' to
2''.
17. The ventilation device of claim 14, wherein the at least one
removable nasal pillow has a groove between the at least two
receiving flanges.
18. The ventilation device of claim 14, wherein the height of the
at least two flanges of the cushioned facial interface is
substantially the same.
19. The ventilation device of claim 14, wherein the height of the
at least two receiving flanges of the at least one removable nasal
pillow is substantially the same.
20. The ventilation device of claim 14, wherein the at least one
removable nasal pillow is a first removable nasal pillow and a
second removable nasal pillow, wherein the first removable nasal
pillow may couple with the cushioned facial interface at a first
height and the second removable nasal pillow may couple with the
cushioned facial interface at a second height.
Description
FIELD OF THE INVENTION
[0001] This invention relates generally to the field of respiration
or breathing assist masks. In particular, the invention relates to
respiration or breathing assist masks utilizing both the nose and
mouth.
BACKGROUND
[0002] Obstructive sleep apnea syndrome (commonly referred to as
obstructive sleep apnea, sleep apnea syndrome, and/or sleep apnea)
is a medical condition that includes repeated, prolonged episodes
of cessation of breathing during sleep. During a period of
wakefulness, the muscles of the upper part of the throat passage of
an individual keep the passage open, thereby permitting an adequate
amount of oxygen to flow into the lungs. During sleep, the throat
passage tends to narrow due to the relaxation of the muscles. In
those individuals having a relatively normal-sized throat passage,
the narrowed throat passage remains open enough to permit the
adequate amount of oxygen to flow into the lungs. However, in those
individuals having a relatively smaller-sized throat passage, the
narrowed throat passage prohibits the adequate amount of oxygen
from flowing into the lungs. Additionally, a nasal obstruction,
such as a relatively large tongue, and/or certain shapes of the
palate and/or the jaw of the individual, further prohibit the
adequate amount of oxygen from flowing into the lungs.
[0003] An individual having the above-discussed conditions can stop
breathing for one or more prolonged periods of time (e.g. ten
seconds or more). The prolonged periods of time during which
breathing is stopped, or apneas, are generally followed by sudden
reflexive attempts to breathe. The reflexive attempts to breathe
are generally accompanied by a change from a relatively deeper
stage of sleep to a relatively lighter stage of sleep. As a result,
the individual suffering from obstructive sleep apnea syndrome
generally experiences fragmented sleep that is not restful. The
fragmented sleep results in one or more of excessive and/or
inappropriate daytime drowsiness, headache, weight gain or loss,
limited attention span, memory loss, poor judgment, personality
changes, lethargy, inability to maintain concentration, and/or
depression.
[0004] Other medical conditions can also prevent individuals,
including adults and infants, from receiving the adequate amount of
oxygen into the lungs. For example, an infant who is born
prematurely can have lungs that are not developed to an extent
necessary to receive the adequate amount of oxygen. Further, prior
to, during and/or subsequent to certain medical procedures and/or
medical treatments, an individual can be unable to receive the
adequate amount of oxygen. Under these circumstances, it is known
to use a ventilation interface to apply a positive pressure to the
throat of the individual, thereby permitting the adequate amount of
oxygen to flow into the lungs. In the known ventilation interface,
oxygen and/or room air containing oxygen is delivered through the
mouth and/or nose of the individual. Existing types of positive
pressure applied by the known ventilation interface include
continuous positive airway pressure (CPAP), in which a positive
pressure is maintained in the throat passage throughout a
respiratory cycle, bi-level positive airway pressure (BiPAP), in
which a relatively high positive pressure is maintained during
inspiration and a relatively low positive pressure is maintained
during expiration, and intermittent mechanical positive pressure
ventilation (IPPV) in which a positive pressure is applied when
apnea is sensed (I.e., the positive airway pressure is applied
intermittently or non-continuously).
[0005] One conventional ventilation interface for the application
of positive pressure includes a face mask that covers both the nose
and the mouth. See, for example, U.S. Pat. Nos. 4,263,212 to
Mizerak and 6,123,071 to Berthon-Jones et al. Other face masks
include configurations that cover only the nose or only the mouth.
Standard masks have air supplied under pressure and use headgear or
harnesses configured at least with what is referred to as a lip
strap, thereby preventing air from escaping from the user's mouth.
Such a strap is positioned level the patient's lips and wasp
circumferentially around the patient's head from one side of the
mask to the other. To keep the supply of positive gas pressure and
to maintain the required seal that prevents the gas supply from
leaking, a force must be applied to the head of the individual. As
a result, the harness is generally uncomfortable to wear,
particularly when sleeping. The applied pressure often results in
undesirable irritation and sores caused by movement of the mask and
harness during periods of both wakefulness and sleep. Further, the
required seal is generally difficult to maintain when the mask and
harness is moved.
[0006] The force that the harness applied to the mask against the
face also applies an undesirable pressure to the sinus area
adjacent to the nose, causing the nasal sinus airways to narrow.
This narrowing causes an increase in the velocity of flow through
the upper anatomical airways and a decrease in the lateral pressure
against the nasal mucosal wall. Additionally, if the tubing between
the mask and the gas supply unit folds undesirably, this problem
will be exacerbated. The above-discussed combination of increased
flow velocity and decreased pressure results in the removal of
moisture form the mucosal walls during inspiration and may cause an
undesirable drying and a burning sensation within the nares. As a
result, the individual may remove the mask to alleviate these
discomforts, consequently discontinuing the beneficial application
of the positive pressure. Such increased air flow velocity and
decreased pressure deteriorate the laminar flow between the air
input and output portions of the conventional mask.
[0007] A common complaint of a patient regarding ventilation masks
is that they cause claustrophobia. Such masks have large headgear
that wrap around the entirety of the user's head and cover a
significant area of the face including the periphery of both the
nose and the mouth. Additionally such masks have a large amount of
dead space within the mask where gas can be re-breathed by a
patient, and a large area against the face of a user that must be
sealed against the mask.
SUMMARY
[0008] In one exemplary embodiment, a respiration assist mask is
disclosed. The respiration assist mask may include a ventilation
interface. A cushion may be connected to the ventilation interface
and the cushion may have one or more openings designed to receive
one or more inputs. Additionally, the respiration assist mask may
have at least one nasal pillow that may be adjustably coupled to
the cushion.
[0009] In another exemplary embodiment, a method of providing
respiration assistance is disclosed. The method may include
coupling at least one nasal pillow with at least one flange with a
cushion having at least one flange. Additionally, the cushion may
be coupled to a ventilation interface. Further, breathable gas may
be provided to the ventilation interface.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 shows an exploded view of an exemplary embodiment of
the invention.
[0011] FIG. 2 shows a side perspective view of an exemplary
embodiment of the invention.
[0012] FIG. 3 shows a front view of an exemplary embodiment of the
invention.
[0013] FIG. 4 shows a back view of an exemplary embodiment of the
invention.
[0014] FIG. 5 shows a top view of an exemplary embodiment of the
invention.
[0015] FIG. 6 shows a bottom view of an exemplary embodiment of the
invention.
[0016] FIG. 7 shows a right side view of an exemplary embodiment of
the invention.
[0017] FIG. 8 shows a left side view of an exemplary embodiment of
the invention.
[0018] FIG. 9 shows a top-down view of an exemplary embodiment of
the invention.
[0019] FIG. 10 shows a rotated top-down view of an exemplary
embodiment of the invention.
[0020] FIG. 11 shows a bottom-up view of an exemplary embodiment of
the invention.
[0021] FIG. 12 shows a side view of an exemplary embodiment of the
invention.
[0022] FIG. 13 shows a front view of an exemplary embodiment of the
invention.
[0023] FIG. 14 shows cut out views of membranes in another
exemplary embodiment of the invention.
[0024] FIG. 15 shows cut out view of membranes in another exemplary
embodiment of the invention.
[0025] FIG. 16 shows a top-down view of an exemplary embodiment of
the invention.
[0026] FIG. 17 shows a rotated top-down view of an exemplary
embodiment of the invention.
[0027] FIG. 18 shows a bottom-up view of an exemplary embodiment of
the invention.
[0028] FIG. 19 shows a side view of an exemplary embodiment of the
invention.
[0029] FIG. 20 shows a front view of an exemplary embodiment of the
invention.
[0030] FIG. 21 shows cut out views of membranes in another
exemplary embodiment of the invention.
[0031] FIG. 22 shows cut out view of membranes in another exemplary
embodiment of the invention.
[0032] FIG. 23 shows an exemplary view of a pair of nasal
pillows
[0033] FIG. 24 shows an exemplary rotated view of a pair of nasal
pillows.
[0034] FIG. 25 shows an exemplary rotated view of a pair of nasal
pillows.
[0035] FIG. 26 shows an exemplary perspective view of a nasal
pillow.
[0036] FIG. 27 shows an exemplary cross sectional view of a nasal
pillow.
[0037] FIG. 28 shows an exemplary rotated view of a pair of nasal
pillows.
[0038] FIG. 29 shows an exemplary top-down view of a nasal
pillow.
[0039] FIG. 30 shows an exemplary side view of a nasal pillow.
[0040] FIG. 31 shows an exemplary bottom-up view of a nasal
pillow.
[0041] FIG. 32 shows an exemplary side view of a nasal pillow.
[0042] FIG. 33 shows an exemplary rotated view of a nasal
pillow.
[0043] FIG. 34A shows an exemplary cross-sectional view of a pair
of nasal cushions.
[0044] FIG. 34B shows an exemplary cross-sectional view of a pair
of nasal cushions.
[0045] FIG. 35A shows an exemplary view of a cushioned interface
having adjustable nasal pillows.
[0046] FIG. 35B shows an exemplary cross-sectional view of a
cushioned interface having adjustable nasal pillows
[0047] FIG. 35C shows an exemplary cross-sectional view of a
cushioned interface having adjustable nasal pillows.
[0048] FIG. 36A shows an exemplary cross-sectional view of an
adjustable nasal pillow for a ventilation interface.
[0049] FIG. 36B shows an exemplary cross-sectional view of an
adjustable nasal pillow for a ventilation interface.
[0050] FIG. 37A shows an exemplary view of a cushion for a
ventilation interface having adjustable nasal pillows.
[0051] FIG. 37B shows an exemplary cross-sectional view of a
cushion for a ventilation interface having adjustable nasal
pillows.
[0052] FIG. 37C shows an exemplary cross-sectional view of a
cushion for a ventilation interface having adjustable nasal
pillows.
[0053] FIG. 38 shows an exemplary view of a cushion for a
ventilation interface having adjustable nasal pillows.
[0054] FIG. 39 shows an exemplary view of a cushion for a
ventilation interface having adjustable nasal pillows.
[0055] FIG. 40 shows an exemplary view of a cushion for a
ventilation interface having adjustable nasal pillows.
[0056] FIG. 41A shows an exemplary view of a ventilation interface
having adjustable nasal pillows.
[0057] FIG. 41B shows an exemplary perspective view of a
ventilation interface having adjustable nasal pillows.
[0058] FIG. 41C shows an exemplary cross-sectional view of a
ventilation interface having adjustable nasal pillows.
[0059] FIG. 42 shows an exemplary view of a ventilation interface
having adjustable nasal pillows.
[0060] FIG. 43A shows an exemplary view of a ventilation interface
having adjustable nasal pillows.
[0061] FIG. 43B shows an exemplary cross-sectional view of a
ventilation interface having adjustable nasal pillows.
[0062] FIG. 44A shows an exemplary view of a ventilation interface
having adjustable nasal pillows.
[0063] FIG. 44B shows an exemplary cross-sectional view of a
ventilation interface having adjustable nasal pillows.
[0064] FIG. 44C shows an exemplary cross-sectional view of a
ventilation interface having adjustable nasal pillows.
[0065] FIG. 45A shows an exemplary view of a ventilation interface
having adjustable nasal pillows.
[0066] FIG. 45B shows an exemplary cross-sectional view of a
ventilation interface having adjustable nasal pillows.
DETAILED DESCRIPTION
[0067] Aspects of the invention are disclosed in the following
description and related drawings directed to specific embodiments
of the invention. Alternate embodiments may be devised without
departing from the spirit or the scope of the invention.
Additionally, well-known elements of exemplary embodiments of the
invention will not be described in detail or will be omitted so as
not to obscure the relevant details of the invention. Further, to
facilitate an understanding of the description discussion of
several terms used herein follows.
[0068] The word "exemplary" is used herein to mean "serving as an
example, instance, or illustration." Any embodiment described
herein as "exemplary" is not necessarily to be construed as
preferred or advantageous over other embodiments. Likewise, the
term "embodiments of the invention" does not require that all
embodiments of the invention include the discussed feature,
advantage or mode of operation.
[0069] Generally referring to FIGS. 1-8, a ventilation interface
mask is disclosed. The interface may be used for a variety of
purposes, for example providing continuous positive airway pressure
to a user. The ventilation interface may alleviate concerns some
users have by being small than other types of ventilation masks and
by eliminating portions of the mask that fit over the nose of a
user. Additionally, by eliminating the portions of a mask that fit
over the nose of a user, less sealing is required against the face
of a user. Also, the small size of the ventilation interface
reduces the amount of space on the interior of the mask, thus
resulting in less gas to exhaust and a decreased amount of gas that
is breathed more than once.
[0070] FIG. 1 shows an exploded view of an exemplary embodiment of
a respiration assist mask. Respiration assist mask 2 may have
several separable components, such as ventilation interface 4,
cushioned facial interface 6, nasal inserts 8 and 9, and gas supply
tube 10. In one embodiment of the invention, supply tube 10 may be
connected to ventilation interface 4 in order for input gas may be
supplied to the device. In a further embodiment, facial interface 6
may be joined with ventilation interface 4. Ventilation interface 4
may also accept nasal inserts 8 through receiving holes 12 and 14.
The respiration assist mask 2 may then be positioned over the mouth
of a user such that facial interface 6 forms an airtight seal over
the mouth of the user. Additionally, in a further embodiment,
facial interface 6 may form a seal against the upper and lower lips
of the user. When respiration assist mask 2 is positioned over the
mouth of a user, the user may insert nasal inserts 8 and 9 into the
nares of a user. When nasal inserts 8 and 9 are inserted into the
nares of a user, an airtight seal may be formed.
[0071] In another exemplary embodiment, nasal inserts 8 and 9 may
be formed in a variety of shapes, for example the volcano style
shown in FIG. 1. Additionally, any size or shape nasal insert that
fits into the nares of a user and optionally provides an airtight
seal may be used with respiration assist mask 2. Nasal inserts may
be formed from any suitable material, for example silicone. In a
further embodiment, nasal inserts 8 and 9 may be connected by
connector 16. Connector 16 may be formed out of any material and
is, optionally, formed out of the same material as the nasal
inserts. Connector 16 can also be separable from nasal inserts 8
and 9, or, in a different embodiment, nasal inserts 8 and 9 can be
formed without a connector. If connector 16 is fitted to nasal
inserts 8 and 9, it may function to prevent the rotation of nasal
inserts 8 and 9 when they are engaged on facial interface 6 in
receiving holes 12 and 14, respectively. Additionally, connector 16
may act to retain nasal inserts 8 and 9 in a desired position.
Alternatively, connector 16 may be removed to allow for rotation of
nasal inserts 8 and 9 in receiving holes 12 and 14, respectively.
Further, if connector 16 is removed, two different size nasal
inserts may used and attached to respiration assist mask 2 if it is
needed or desired by a user.
[0072] In another embodiment shown in FIG. 1, nasal inserts 8 and 9
may be formed with elliptical distal ends 18 and 20, respectively.
Elliptical ends 18 and 20 may be formed so as to provide
comfortable and airtight seals within the nares of a user.
Connector 16 may be positioned on nasal inserts 8 and 9 so as to
hold nasal inserts 8 and 9 in a position which provides a
comfortable and airtight seal in the nares of the user.
[0073] In yet another embodiment shown in FIG. 1, facial interface
6 may provide an airtight seal against the face of a user.
Additionally, facial interface 6 may act as a cushion against the
face of a user. Similar to the removable cushion disclosed in U.S.
Pat. No. 6,595,214 (the '214 patent), which was incorporated by
reference into Provisional U.S. Patent Application No. 60/634,188
to which priority is claimed, facial interface 6 may act as a
removable cushion that attaches to a ventilation interface. Facial
interface 6 may also act to form a seal against an upper and/or
lower lip of a user.
[0074] Additionally, facial interface 6 may include chin flap 22.
When respiration assist mask 2 is placed on the face of a user,
chin flap 22 may be positioned under the chin of the user. In one
embodiment, chin flap 22 may provide additional sealing against the
face of a user. Additionally, in another embodiment, chin flap 22
may act to provide additional comfort for a user. In a further
embodiment, chin flap 22 can act to limit the movement of the lower
jaw of a user.
[0075] In yet a further embodiment shown in FIG. 1, facial
interface 6 may have multiple membranes 24a, 24b and 24c
(collectively membranes 24). Membranes 24 may serve to provide
additional seals against the face of a user. For example, membranes
24, and specifically membrane 24a, may seal against an upper and/or
lower lip of a user who is wearing respiration assist mask 2. In
this exemplary embodiment, membrane 24a may be formed to be thinner
than membrane 24b. Thus, membrane 24a can adhere to facial contours
and fill small facial gaps as it can be a thin, flexible material.
Additionally, membrane 24b may be thicker than membrane 24a to
provide auxiliary sealing against the face of a user and provide
structural support for the device. For example, membrane 24a may be
made of any suitable material, for example silicone, and may be
approximately 0.020'' thick. Membrane 24b may also be made of any
suitable material, for example silicone, and have a thickness of
approximately 0.050''. Still other parts of facial interface 6, for
example 24c, may have a thickness of approximately 0.100''. This
thickness may extend around the periphery of that portion of the
device.
[0076] Also, membranes 24 may work in conjunction with chin flap 22
to provide additional sealing capabilities. As stated previously,
in one embodiment, chin flap 22 may act to limit the movement of
the lower jaw of a user. In a further embodiment, chin flap 22 may
have some elasticity which allows a user wearing respiration assist
mask 2 to move their jaw and, for example, open their mouth. In the
event of this happening, membrane 24a, which also may be elastic,
may stretch upper portion of the lower jaw of the user, thus
maintaining the seal between the interface and a wearer's face.
Membrane 24b, which may also be elastic, may then stretch against
the bottom portion of the mouth of the user, thus maintaining an
airtight seal between facial interface 6 and the face of a
user.
[0077] Moreover, in a further exemplary embodiment of the
invention, movement of the lower jaw of a user will not break the
airtight seal of respiration assist mask 2 against the face of a
user or dislodge the nasal inserts which may be positioned against
the nares of a user. In this embodiment, when the mouth of a user
wearing the mask opens, chin flap 22 allows facial interface 6 to
stretch. For example, if a user were to open their mouth, the lower
jaw of the user would move against chin flap 22, but remain in
contact with chin flap 22 as it stretches. Thus, when facial
interface 6 stretches, membranes 24 remain sealed against the
moving face of the user.
[0078] In another embodiment shown in FIG. 1, facial interface 6
may have contoured surfaces around receiving holes 12 and 14. These
contoured surfaces may work in conjunction with flange 26 of nasal
insert 8 and flange 28 of nasal insert 9. Contoured surface 30 and
contoured surface 32 may act to hold nasal insert 8 and nasal
insert 9, respectively, in a position that allows for an airtight
seal to be formed between the nasal inserts and the nares of a user
wearing respiration assist mask 2. Also, contoured surfaces 30 and
32 may act to provide an airtight seal between nasal inserts 8 and
9, respectively and facial interface 6. In a further embodiment,
contoured surfaces 30 and 32 can act to angle nasal inserts 8 and
9, respectively, towards each other and thus orientate them to be
better received into the nares of a user.
[0079] In another exemplary embodiment shown in FIG. 1, auxiliary
ports 34 and 36 may be positioned on ventilation interface 4.
Auxiliary ports 34 and 36 may be positioned on an upper portion of
interface 4 and may project outwardly. Additionally, when they are
not being otherwise utilized, auxiliary ports 34 and 36 may be
capped with coverings 38 and 40, respectively. Auxiliary ports may
be used, for example, to connect to outside devices for the
purposes of measuring oxygen or carbon dioxide levels, pressure, or
to connect to any other outside device to provide measurements,
readings or additional inputs. Alternatively, auxiliary ports 34
and 36 may be utilized as exhaust ports to release gas from the
interior portion of ventilation interface 4. Removable coverings 38
and 40 may act to prevent the release of gas from respiration
assist mask 2 and maintain the airtight seal within the device
when.
[0080] Ventilation interface 4 may also have a design such that it
can accept and seal with cushioned facial interfaces of various
sizes. In one exemplary embodiment, cushioned facial interface 6
may be made to have different size or shape cushions or have a
different sealing area. Different size facial interfaces may
maintain a similar size or shape membrane to connect with
ventilation interface 4, however. In other embodiments, different
size facial interfaces may be made out of a material that
stretches, so as to allow for an airtight seal to be formed between
varying sizes of facial interface and ventilation interface 4.
[0081] FIG. 1 also shows input gas tube 10, which may be formed in
an elbow shape or any other shape which may attach to ventilation
interface 4. Input gas tube may be used to deliver any type of gas
or aerosol and may be used in any type of respiration application,
such as CPAP or BiPAP applications. Input gas tube 10 may have
connection portion 42 which can be used to connect input gas tube
10 to ventilation interface 4 through the use of receiving hole 48.
Connection portion 42 may be threading, allowing input gas tube 10
to be screwed into receiving hole 48 or any other connection and
sealing mechanism, such as a clip or a clasp. Input gas tube 10 may
also have valve 44 disposed on its surface. Valve 44 may be coupled
with a flap, held in place by connector 46, which is closed in an
airtight seal when ventilation gas is being passed through input
gas tube 10. However, if there is no gas being inputted through
tube 10, the flap will open, allowing outside air to enter
respiration assist mask 2.
[0082] In another embodiment of the invention, the device may be
worn on the face of a user with any of a variety of types of
headgear. The headgear may attach to respiration assist mask 2
through the use of headgear attachment posts 50. Attachment posts
50 may be positioned at various portions of ventilation interface
4, for example at the top and bottom of either side face 4. In a
further embodiment, the headgear may have female connectors that
allow for the headgear to be securely fastened to male attachment
posts 50. In a different embodiment, the headgear may have looped
ends that securely fit around attachment posts 50. Additionally,
any other known type of attachments or posts may be used to
securely attach headgear to respiration assist mask 2 in such as
manner as to provide for the comfort of a user and allow for an
airtight seal to be formed between the face of a user and
respiration assist mask 2.
[0083] FIG. 2 shows another exemplary embodiment where the
components of the device are joined together. In this embodiment,
gas input tube 10 may be securely connected to ventilation
interface 4 through any of the methods mentioned previously.
Additionally, tube 10 may be secured to face 4 to provide an
airtight seal between the tube and the face, but it may be
rotatably engaged to the face. Thus input gas tube 10 may be
rotated so that a feed tube that may, optionally, be connected to
input gas tube 10 can be mounted in any location or position and
continue to supply input gas to respiration assist mask 2.
[0084] FIG. 2 also shows how ventilation interface 4 can be
connected to facial interface 6. The mating of these two devices
can create an airtight seal between face 4 and connector 6.
Additionally, any known method of connecting the two components may
be utilized, such as tongue in groove, clasps, clips or the like.
Connector 6 may also serve to enhance the structural rigidity of
respiration assist mask 2. For example, the top portion and side
portions of connector 6 may be thicker than other portions of
connector 6. This can allow for stabilization of nasal inserts 8
and 9 when they are joined with connector 6. Further, this may
prevent fore and aft movement as well as lateral movement of nasal
inserts 8 and 9 when they are joined with connector 6, and may also
act to enhance the seal between the nasal inserts 8 and 9 and
connector 6.
[0085] In a further embodiment shown in FIG. 2, nasal inserts 8 and
9 are shown connected to facial interface 6 through the use of
receiving holes 12 and 14. This connection may also form an
airtight seal between nasal inserts 8 and 9 and facial interface
6.
[0086] The assembled respiration assist mask 2 shown in FIG. 2 may
be joined to provide airtight seals between each of the components.
Additionally, when the device is positioned on the face of a user,
an airtight seal may exist between the interior portion of
respiration assist mask 2 and the face of the user.
[0087] In a further embodiment of the invention, exhaust ports 52
may be disposed on the face of respiration assist mask 2. In one
exemplary embodiment, a series of exhaust ports 52 may be formed on
the surface of ventilation interface 4. These ports 52 may be
utilized to release or output carbon dioxide that is exhaled by a
user wearing the mask. In an alternative embodiment, the exhaust
ports may protrude from ventilation interface 4. In another
embodiment, a different number of exhaust ports that may be larger
or smaller may be utilized on ventilation interface 4. In yet
another embodiment, one or more exhaust ports have adjustable
apertures or adjustable flow rates may be disposed on ventilation
interface 4. In still another embodiment, exhaust ports 52 may be
capable of being capped or sealed from the interior or exterior of
ventilation interface 4 so as to vary the flow rate of exhaust
gases. In another exemplary embodiment, exhaust ports 52 may be
disposed on any location of ventilation interface 4.
[0088] In a further embodiment shown in FIGS. 3 and 4, facial
interface 6 may have an upper portion that is positioned against
the upper lip of a user. For example, upper portion 6a of facial
interface 6 may rest snugly against the upper lip of a user when
respiration assist mask 2 is being worn. Upper portion 6a may act
to create an airtight seal between the upper lip of a user wearing
the device and connector 6. Additionally, upper portion 6a may act
as an anchor portion for respiration assist mask 2 when it is being
worn by a user. Thus if a user, for example, opens their mouth and
moves their lower jaw while wearing the device, upper portion 6a of
connector 6 will anchor respiration assist mask 2 on the face of
the user to prevent it from being dislodged, which could
potentially cause a break in the airtight seal between respiration
assist mask 2 and the face of a user. Further, when upper portion
6a acts as an anchor, it may prevent forces on chin flap 22 caused
by jaw or mouth movement of a user wearing the device from
affecting the positioning and sealing of nasal inserts 8 and 9,
which may be inserted into the nares of a user wearing the device.
In this embodiment, stress exerted elsewhere on respiration assist
mask 2 will not be translated into movement of nasal inserts 8 and
9 within the nares of a user and can prevent the dislodging of the
nasal inserts from the nares.
[0089] In another embodiment of the invention shown in FIG. 4,
upper portion 6a may also prevent movement of nasal inserts 8 and 9
when respiration assist mask 2 is worn or adjusted by a user. For
example, if respiration assist mask 2 is worn on the face of a user
through the use of headgear attached to posts 50, the user will
likely need or desire to adjust the headgear so as to have comfort
while ensuring the device is positioned properly. In previous
devices having nasal inserts, the tightening of headgear on the
head of a user would likely cause articulation and movement apart
of the nasal inserts as the device onto which the nasal inserts was
mounted stretched as the headgear was tightened. This articulation
and movement can cause discomfort for a user and may dislodge the
nasal inserts from the nares of a user. In this embodiment,
however, upper portion 6a of connector 6 acts as an anchor for
respiration assist mask 2 because it is positioned against the
upper lip of a wearer to create a seal. Therefore any forces acting
upon respiration assist mask 2 by the use or tightening of headgear
will be absorbed by upper portion 6a of connector 6, rather than by
nasal inserts 8 and 9. Thus, the comfort of a user wearing the
device can be enhanced and there is a reduced possibility of nasal
inserts 8 and 9 being moved within the nares of a user or
dislodged, causing a break in the seal.
[0090] FIG. 5 shows a top down view of another embodiment of the
invention. In this embodiment, nasal inserts 8 and 9 are shown as
being angled towards each other. In other embodiments, nasal
inserts 8 and 9 may be angled or orientated differently depending
on the fitting required or desired by a user. Additionally, hole 54
on nasal insert 8 and hole 56 on nasal insert 9 may be elliptical.
Other sizes and shapes of the holes may be utilized depending on
the application and wearer of ventilation interface 2.
[0091] FIG. 6 shows a bottom up view of a different embodiment of
the invention. This embodiment provides a bottom perspective facial
interface 6 and chin flap 22. Additionally, one example of the
placement of attachment posts 50 is shown. FIG. 6 also demonstrates
the seal and one possible way of joining facial interface 6 and
ventilation interface 4 where facial interface 6 fits into
ventilation interface 4 in a tongue-in-groove fashion.
[0092] FIGS. 7 and 8 show exemplary side views of the invention. In
this embodiment, chin flap 22 on facial interface 6 extends beyond
other portions of facial interface 6. Additionally, interface
connector may have shaped edges which can contour to the face of a
user to better provide a seal against the face of the user. FIGS. 7
and 8 also show auxiliary ports 34 and 36 as being disposed inside
recessed or cut out portions of ventilation interface 4. In other
embodiments of the invention, auxiliary ports 34 and 36 may be
disposed in an area on ventilation interface 4 that is not cut out
or recessed.
[0093] FIGS. 9-22 show an exemplary embodiment of cushioned facial
interface 6. In this embodiment various membranes are shown as well
as the difference between membranes. For example, the facial
interface shown in FIGS. 9-15 may be smaller than the facial
interface shown in FIGS. 16-22. Despite any size differences in the
facial interfaces, both may be used interchangeably with
ventilation interface 2 and nasal inserts 8 and 9 without any
alterations to those devices. Additionally, as shown in FIGS. 14-15
and 21-22, membrane 24a is shown as an outer membrane that is
thinner than inner membrane 24b. As discussed previously, membrane
24a can be made of any suitable material, such as silicone. As
discussed above, membrane 24a is thin so as to be able to follow
the contours of a user's face and provide a seal between facial
interface 6 and the face of the user. Moreover, the thin membrane
may be able to stretch in order to maintain a seal when the user's
face moves, for example, such as when the user opens their mouth.
Membrane 24b is shown as being thicker than membrane 24a and is
also positioned inside membrane 24a. Membrane 24b may also be made
out of any suitable material, such as silicone, and, as discussed
above, may be thicker to provide support on the inside of mask 2.
Membrane 24b may also serve to act as a "stop." In other words,
membrane 24b may limit the amount of movement a user may have while
wearing the mask, for example, preventing the user from opening
their mouth beyond a certain point.
[0094] Additionally, as shown in FIG. 11, the differences in the
areas separating various membranes can be seen. As shown in FIGS.
11 and 18, the distance between membranes 24a, 24b and 24c is
larger on axis A-A than it is on the E-E axis. The distance between
membranes 24a-c on axis A-A can allow for increased user comfort
and utility, as a seal can be made around the entire mouth of the
user. Additionally, by having a seal around the entire mouth area,
the structural rigidity of mask 2 can be increased. Further,
because of the increased structural rigidity, a user may be able to
tighten mask 2 on their face without causing flex in the central or
peripheral portions of the mask which could lead to the seal
between the user's face and the facial interface being broken. This
membrane structure can also allow downward pressure to be exerted
on nasal inserts 8 and 9 without dislodging nasal inserts 8 and/or
9 and without significantly deforming facial interface 6 so as to
cause a break in the seal between the face of the user and facial
interface 6.
[0095] Referring generally to FIGS. 23-44, components of a
ventilation interface that may be adjustable in various manners are
disclosed.
[0096] An exemplary view of a pair of nasal pillows is shown in
FIG. 23. The nasal pillows may be a connected pair or, in another
exemplary embodiment, may be disposed separately. In this exemplary
embodiment, a pair of nasal pillows is shown as having opening 62
at a distal end of a nasal pillow, as well as nasal insert portion
60. Nasal insert portion 60 may flare out from opening 62 so as to
provide a comfortable fit against the nares of a user.
Additionally, connector 64 is shown as coupling a pair of nasal
pillows. Connector 64 may be formed out of any soft or rigid
material and may be attachable and detachable from one or both
nasal pillows.
[0097] FIG. 24 is another exemplary view of a pair of nasal
pillows. This exemplary embodiment shows flanges 68, 70, and 72,
which may be disposed around a perimeter of a nasal pillow. Flanges
68, 70 and 72 may be inserted into a cushion associated with a
ventilation interface, for example openings 12 and 14 of cushion 6.
The nasal pillows may be inserted into cushion 6 and provide a
gas-tight seal between the cushion and the nasal pillows.
Additionally, the nasal pillows may be inserted into cushion 6 and
form a seal between flange 72 and cushion 6, flange 70 and cushion
6 or flange 68 and cushion 6. Thus, the height of the nasal pillows
may be varied by a user to obtain a more beneficial height. In
another exemplary embodiment, any number of additional flanges may
be disposed on a nasal pillow, in additional to flanges 68, 70 and
72, which can allow for a larger degree of adjustment to be
obtained. Additionally, the size of the flanges and distance
between the flanges may be varied, changed or adjusted, so as to
provide additional adjustability.
[0098] In another exemplary embodiment shown in FIG. 25, a pair of
nasal pillows is again shown. In this exemplary view, indented
portion 74 of a nasal pillow is shown. Indented portion may act to
compress when a nasal insert is inserted into the nares of a user.
This compression may allow for better fitment and comfort of the
nasal pillow as well as provide for an additional adjustment of
height, depending on how the user inserts nasal insert portion 60.
Additionally, indented portion 74 can allow for lateral and fore
and aft movement of the nasal pillow. Thus, comfort may be
increased and additional adjustments may be made to the fitment of
the nasal pillows.
[0099] FIG. 26 shows an exemplary view of a single nasal pillow.
This nasal pillow may be separated from another nasal pillow
through the removal of connector 64. Additionally, a single nasal
pillow of a first size may be pair with a second nasal pillow
having a second size, thus allowing for additional levels of
adjustment to be performed by a user. FIG. 27 shows an exemplary
cross sectional view of a single nasal pillow. From this view, an
exemplary orientation of various flanges and grooves may be seen.
For example, flanges 68, 70 and 72 appear in a rotated view as
compared to FIG. 24. Additionally, grooves 66 and 67 may be seen in
this cross-sectional view. Grooves 66 and 67 may act to slot into
openings 12 and 14 of cushion 6, for example. After grooves 66 and
67 are fitted into either opening 12 or 14, flanges 68, 70 and 72
may act to provide a gas tight seal between the nasal pillow and
cushion 6 and may use friction, or any manner of preventing
movement, to hold a nasal pillow in a location or orientation that
is desired by a user.
[0100] FIG. 28 shows an exemplary rotated view of a pair of nasal
inserts. In this view is can be seen that indented portion 74 may
again be compressed or expanded, depending on the fitment desired
by a user.
[0101] FIG. 29 is an exemplary top-down view of a nasal pillow.
This view allows for a view of opening 62, which may be circular,
oval, substantially circular, substantially oval, or any other
shape. Additionally, nasal insert portion 60 may flare out of the
perimeter of opening 62, allowing for a user to insert the nasal
pillow to a desired, function and comfortable depth. Nasal insert
portion 60 may also act to provide a gas tight seal between a nasal
pillow and the nares of a user. FIG. 31 provides an exemplary
bottom-up view of a nasal pillow. From this view it is shown that
the bottom portion of a nasal pillow may be of a greater area than
opening 62.
[0102] FIGS. 30, 32 and 33 show additional exemplary embodiments of
a nasal pillow. As shown in FIG. 30, indented portion 74 may be of
a different diameter than in previous embodiments. This can allow
for different degrees of adjustability, as a thinner indented
portion 74 may allow for more fore and aft movement and more
lateral movement. Additionally, a thinner indented portion 74 may
allow for indented portion 74 to have a higher level of
compression. FIGS. 32 and 33 show another embodiment of a nasal
pillow with different sized features. In one exemplary embodiment,
opening 82 can be larger or smaller than that in previous
embodiments. Additionally, nasal insert portion 84 can have a
lesser slope or a greater slope from opening 82, as well as
different surface areas than previous embodiments. These different
orientations of a nasal pillow may allow for the device to fit in
the nares of various-sized nares. Additionally, it can allow for
flexibility in using a first nasal pillow with a second nasal
pillow, if a user has different sized nares. Additionally, indented
portion 80 may also have a larger or smaller diameter than in
previous embodiments. This, coupled with other larger or smaller
features, may allow for a greater or lesser amount of gas flow
through a ventilation interface and into the nares of a user. The
gas flow provided to a user may be varied through the use of
different sized nasal inserts and nasal pillows depending on the
needs of that user.
[0103] In another embodiment of the invention shown in FIG. 34,
different cushions may utilize different amount of flanges. For
example, in FIG. 34a, opening 88 is shown with a singular flange
90. Flange 90 may act to receive and seal with a nasal pillow
having one or more flanges and which may or may not be adjustable
in height. In FIG. 34b, multiple flanges 94 may act with opening 92
to receive a nasal pillow having one or more flanges. Flanges 94
can be used to adjust the height of a nasal pillow having a single
flange or may be used with a nasal pillow having multiple flanges
to provide a greater degree of vertical adjustability. Each portion
of flanges 94 may individually act to couple and seal with a nasal
pillow. In a further embodiment, any number of flanges may be
disposed on cushion 86 and may provide for a varying amount of
adjustability of a cushion, nasal pillow or spacer.
[0104] FIGS. 35a-c show yet another exemplary embodiment of a
ventilation interface utilizing nasal pillows that may be adjusted.
Here, as shown in FIG. 35a, nasal pillows 96 and 98 may have
multiple flanges 100 and 102, respectively. Flanges 100 and 102 may
be used to couple nasal pillows 96 and 98, respectively, to cushion
104. Flanges 100 and 102 may couple with receiving flanges 106 and
108, respectively, of cushion 104. Receiving flanges 106 and 108
may be disposed on cushion 104 and may include any number of
flanges. Additionally, receiving flanges 106 and 108 may be
disposed on cushion 104 in any manner, for example molding,
adhesion or any other manner known to one having ordinary skill in
the art.
[0105] In one example shown in the cutaway view of FIG. 35b, nasal
pillow 98 is shown as being coupled with cushion 104 through
opening 112. Here nasal pillow 98 may be in a raised position from
cushion 104, as the upper flange of flange 108 is used to couple
pillow 98 with cushion 104. In another exemplary embodiment shown
in FIG. 35c, nasal pillow 98 is in a lower position relative to
that shown in FIG. 35b. Here the lower flange of flange 108 may be
used to couple pillow 98 with cushion 104. In further exemplary
embodiments, any number of flanges may be disposed on nasal pillows
96 or 98 and any number of receiving flanges 106 and 108 may be
disposed on cushion 104. Therefore, nasal pillows 96 and 98 may be
vertically adjusted in a variety of manners and to any height
desired by a user of the ventilation interface.
[0106] In one exemplary embodiment, shown in FIG. 36, one or more
adjustable nasal pillows 114 and 116 may be configured to be
disposed on a cushion. Each nasal pillow 114 and 116 may have a
single assembly groove 118, as shown in FIG. 36A, or multiple
assembly grooves 120, as shown in FIG. 36B. Each nasal pillow may
fit into a cushion, which may have one or more flanges for
receiving assembly groove 118 or assembly grooves 120. Nasal
pillows 114 and 116 may also have nasal insert portions 122 and
124, as well as indented portions 126 and 128. Finally, nasal
pillows 114 and 116 may have openings 130 and 132, which may be
used to deliver breathable gas to the nares of a user.
[0107] In a further exemplary embodiment shown in FIG. 37a-c, one
manner in which nasal pillows may be attached to a cushion is
shown. In the exemplary embodiment of FIG. 37a, nasal pillows 134
and 136 may be configured to be attached to cushion 138. Nasal
pillows 134 and 136 may be inserted into openings 140 and 142,
respectively, on cushion 138. Nasal pillows 134 and 136 may include
flanges 144 and 146, respectively, which act to join and seal the
nasal pillows with cushion 138.
[0108] FIGS. 37b and 37c show cross-sectional, views of the
exemplary embodiment of FIG. 37a. In FIG. 37b, nasal pillow 134 is
shown as separated from cushion 138. Additionally, interior flanges
148 are shown inside flange 144. Interior flanges 148 may interlock
and seal with flanges and grooves 152 that are associated with
opening 140. Nasal pillow 136 is shown as being joined with cushion
138. Nasal pillow 136 may use interior flanges 150 inside flange
146 to interlock and seal with flanges and grooves 154 of opening
142. Nasal pillow 136 can be fitted in the lowest fitting position
for this combination of flanges and grooves. However, any of a
variety of different combinations of flanges and grooves may be
utilized to provide varying degrees of adjustment. FIG. 35c shows a
further exemplary embodiment having nasal pillow 134 fitted in a
low position and nasal pillow 136 fitted in a raised position.
Here, nasal pillow 134 may be coupled with cushion 138. In other
exemplary embodiments, nasal pillow 134 may be either permanently
or removably coupled with cushion 138. Nasal pillow 134 can use
interior flanges 148 inside flange 144 to interlock and seal with
flanges and grooves 152 of opening 140. Nasal pillow 136 can join
with cushion 138 in a raised position. Nasal pillow 136 may use
interior flanges 150 inside flange 146 to interlock and seal with
upper flanges and grooves 154 of opening 142. Other exemplary
embodiments may use nasal pillows of varying sizes and may provide
additional flanges to allow for different adjustments to be made to
the height or orientation of the nasal pillows.
[0109] In another embodiment shown in FIG. 38, a spacer may also
then be utilized in conjunction with both a nasal pillow and a
cushion. In FIG. 38, a pair of nasal pillows, a pair of spacers and
a cushion are shown. Nasal pillows 156 and 158 may be similar to
those described in other embodiments and may have one or more
flanges, for example 160 and 162, respectively, disposed on a lower
portion of each nasal pillow and allowing for varying degrees of
adjustability with respect to cushion 164. Each spacer 166 and 168
may have one or more flanges 170 and 172, respectively. Flanges 170
and 172 may be disposed at varying locations on spacers 166 and
168, respectively. Additionally, spacers 166 and 168 may be able to
join with a nasal pillow and a cushion using flanges 170 and 172,
respectively. In the exemplary embodiment, spacer 166 may be
separated from nasal pillow 156 and cushion 164. Spacer 168,
however, can be either permanently or removably joined with both
nasal pillow 158 and cushion 164. In this example, nasal pillow 158
uses flanges 162 to couple with the upper flanges 172 of spacer
168. A gas tight seal may be formed between nasal pillow 158 and
spacer 168. Additionally, spacer 168 may couple with cushion 164 in
opening 176. Lower flanges 172 of spacer 168 may be used to couple
with the flange disposed at the edges of opening 176, and a gas
tight seal may be provided between the two. Also, the multiple
flanges may allow the spacer to fit into the pillow and the cushion
at different levels. For example, if a user of a cushion desires to
move a pillow away from the cushion, they may utilize a top flange
or flanges of a spacer. If a user of a cushion desires to move a
pillow away from the cushion, for example, they may utilize a lower
flange or flanges of a spacer. In the exemplary embodiment shown in
FIG. 38, the lower portion of flange 172 is not shown as being
utilized; thus a user could adjust nasal pillow 158 and spacer 168
vertically using flange 172 of spacer 168.
[0110] FIG. 39 shows another exemplary embodiment of a pair of
nasal pillows that are joined to a cushion using spacers. Similar
to the embodiment shown in FIG. 38, nasal pillow 170 is shown in an
exploded view and not connected to spacer 166 or cushion 164. Nasal
pillow 172 may again be connected to spacer 168 and cushion 164.
However, in this exemplary embodiment, nasal pillow 172 has been
adjusted vertically. Here, the lower portion of flange 176 of nasal
pillow 172 can be coupled with the upper portion of flange 172 of
spacer 168, as opposed to the exemplary embodiment shown in FIG.
38, where both flanges 176 of nasal pillow 172 were coupled to the
two upper flanges 172 of spacer 168. Thus, in the exemplary
embodiment shown in FIG. 39 nasal pillow 172 has been adjusted
vertically when compared to nasal pillow 172 in FIG. 38.
Additionally, pillow 172 in FIG. 39 may be adjusted in any of a
variety of different matters vertically.
[0111] Another exemplary embodiment of an adjustable nasal pillow
is shown in FIG. 40. Similar to FIGS. 37 and 38, nasal pillow 170
is shown in an exploded view and not connected to spacer 166 or
cushion 164. Nasal pillow 172 may be connected to spacer 168 and
cushion 164. However, in this exemplary embodiment, nasal pillow
172 has again been adjusted vertically. Here, the lower portion of
flange 176 of nasal pillow 172 may be coupled with the upper
portion of flange 172 of spacer 168, similar to the exemplary
embodiment shown in FIG. 39. However, in FIG. 40, the bottom-most
portion of flange 172 on spacer 168 can be used to couple spacer
168 to cushion 164, using opening 176. Thus, in the exemplary
embodiment shown in FIG. 40 nasal pillow 172 has again been
adjusted vertically when compared to nasal pillow 172 in FIG. 39.
Additionally, pillow 172 in FIG. 40 may also be adjusted in any of
a variety of different matters vertically.
[0112] In further exemplary embodiments of FIGS. 34 and 38-40, a
spacer (e.g. 166 or 168) used with a nasal pillow, such as 170 or
172, may have one or more flanges located at varying distances from
each other. The flanges may be formed at different distances for
different spacers, allowing for variable adjustments to be made to
the pillow and cushion. In another embodiment, the spacer may be
formed with one or more flanges or one or more grooves.
Additionally, the cushion and pillow may also be formed with either
flanges or grooves, thus allowing for the spacer to be joined in a
male-female or female-male fashion with the cushion and pillow.
Flanges or grooves used with any of the spacer, cushion or pillow
may be formed in any shape, such as square, fully round, partially
rounded or any combination thereof.
[0113] In yet another exemplary embodiment, the spacer, such as
spacer 166 or 168, may be formed of any soft material, such as
silicone, or any rigid material, such as plastic. Additionally, the
spacer may be formed in a variety of shapes and having a variety of
flanges or grooves regardless of whether the spacer is formed of
any soft or hard material. Also, one or more spacers may be joined
or connected to provide further adjustability of a pillow or
cushion location. For example, an additional spacer could be
coupled to nasal pillow 172 and then coupled with spacer 168.
Additionally, any of the embodiments disclosed in this document may
be used with a single pillow or one or more connected pillows, and
a single spacer, one or more connected spacers, or one or more
axially connected spacers.
[0114] In another exemplary embodiment shown in FIG. 41, a pair of
nasal pillows may be joined with spacers and then coupled with a
cushion for a ventilation interface. In a first view, shown in FIG.
41a, nasal pillows 178 and 180 may use flanges 196 and 198,
respectively (and shown as shrouded in FIG. 41a) to couple with
spacers. Spacer 188 may couple with flange 196 of nasal pillow 178
using flanges 192. A similar coupling may occur between nasal
pillow 180 and spacer 190, although they are shown as already
coupled in this view, thus flanges 194 are not shown in FIG.
41a.
[0115] FIG. 41b shows a side perspective view of the exemplary
embodiment of FIG. 41a. In this view, it is shown that spacer 188
is substantially round. In another exemplary embodiment, spacer 188
may be any shape that may be coupled with nasal pillow 178 and also
may be coupled with opening 196 on cushion 186. Additionally, in
the view shown in FIG. 41b, flanges 192 are shown as extending
around the entire perimeter of spacer 188. In other embodiments of
the invention, flanges 192 may be disposed on only parts of spacer
188, may be arranged in different locations, may be located at
different distances from the other flanges, may be angled or may
not extend around the entire perimeter of a spacer. Additionally,
as shown in
[0116] FIGS. 41a and 41b, cushion 186 may be configured to adhere
to the contours of the face of a user. Cushion 186 may also be
configured on one side to receive a ventilation interface, such as
a plastic interface having a means for accepting input gas, such as
CPAP or BiPAP.
[0117] Additionally, a cross-sectional view of the embodiments
shown in FIGS. 41a and 41b is shown in FIG. 41c. In this view, it
can be seen that nasal pillow 180 can use multiple grooves 198 to
receive the upper portion of spacer 190 flange 194. Additionally,
only a lower portion of spacer 190 flange 194 may be used in
opening 198 to couple spacer 190 to cushion 186. Further, from this
exemplary embodiment, spacers 188 and 190 may be adjusted
vertically on cushion 186 without disturbing the coupling of
spacers 188 and 190 to nasal pillows 178 and 180, respectively.
Additionally, nasal pillows 178 and 180 may be adjusted vertically
on spacers 188 and 190, respectively, without disturbing the
coupling of spacers 188 and 190 with cushion 186. Also, in another
exemplary embodiment, nasal pillows 178 and 180 may be adjusted
vertically on spacers 188 and 190, respectively, while spacers 188
and 190 are being adjusted on cushion 186.
[0118] FIG. 42 shows another exemplary embodiment of a ventilation
interface where nasal pillows may be adjusted through the use of
flanges on the nasal pillows, flanges on the cushion and through
the use of spacers. Here, nasal pillows 204 and 206 may be coupled
with spacers 214 and 216, respectively. Spacers 214 and 216 may
also be coupled with cushion 212. Nasal pillows 204 and 206 in FIG.
42 may also be adjusted to different positions. Nasal pillow 204
may use flanges 208 on two upper flanges 218 of spacer 214. Spacer
214 may then be coupled to opening 226 of cushion 212 through the
use of the upper portion of flange 222. Nasal pillow 206 can use
the bottom portion of flanges 210 on the uppermost flange of
flanges 220 of spacer 216. Spacer 216 can then be coupled to
opening 228 of cushion 212 through the use of the upper portion of
flange 224. In each of these embodiments, each of the nasal
pillows, spacers and cushion may be adjusted independently or in
conjunction with one another. For example, nasal pillow 204 could
be adjusted vertically on spacer 214 without affecting the
positioning of spacer 214 on flange 222 of cushion 212.
Alternatively, spacer 214 could be adjusted on flanges 218 of
cushion 212 without affecting the position of nasal pillow 204 on
spacer 214. In yet another alternative embodiment, the position of
nasal pillow 204 on spacer 214 could be adjusted simultaneously or
in conjunction with the position of spacer 214 on cushion 212.
[0119] In another exemplary embodiment of a ventilation interface
shown in FIG. 43, nasal pillows may be adjusted through the use of
a threaded spacer. Here, as shown in FIG. 43a, nasal pillows 230
and 232 may have flanges 234 and 236, respectively. Flanges 234 and
236 may couple with spacers 240 and 242, respectively. Spacers 240
and 242 may have threaded portions 244 and 246. This threading may
either be male or female and may mate with threaded portions 252
and 254, respectively, of cushion 238. Threaded portions 252 and
254 may be either male or female, so that they may mate with
spacers 240 and 242.
[0120] In FIG. 43b, nasal pillow 230 is shown in a cutaway view as
being separated from spacer 240 and cushion 238. Nasal pillow 232,
however, may be coupled with spacer 242 using flange 236 on pillow
232 and receiving flange 245 on spacer 242. Spacer 242 may then
utilize threads 246 to be threaded into opening 258 of cushion 238.
Flanges 250 on cushion 238 may have internal threading 254 that may
receive the threading of 246 of spacer 242. In one exemplary
embodiment, flanges 250 may have male threading that receives
female threading of spacer 242. Alternatively, flanges 250 may have
female threading that receives male threading of spacer 242. In yet
another exemplary embodiment, cushion 238 and spacer 242 may snap
together, for example with either cushion 238 or spacer 242 having
a post that fits into a receiving hole or slot on the other member.
In yet another exemplary embodiment, cushion 238 and spacer 242 may
be joined by friction. After spacer 242 and cushion 238 are
coupled, a user may twist either nasal pillow 232 or spacer 242.
The twisting may result in a raising or lowering of the height of
nasal pillow 232, as well as a changing of the orientation of nasal
pillow 232. In a further embodiment, both the spacers and flanges
on a cushion may have threading of any length, allowing a user to
adjust one or both nasal pillows to any desired height or
orientation. In yet another embodiment, spacers may be coupled to a
cushion through the use of friction between the spacer material and
the cushion, allowing for an infinite amount of adjustment to be
made to the height and orientation of one or both nasal pillows.
Alternatively, any other method known to one having ordinary skill
in the art may be used to couple a spacer with a cushion.
[0121] FIG. 44 shows yet another exemplary embodiment of a
ventilation interface having adjustable nasal pillows. Similar to
other embodiments, as shown in FIG. 44a, nasal pillows 260 and 262
may have flanges 264 and 266, respectively. Flanges 264 and 266 may
couple with spacers 270 and 272, respectively. Spacers 270 and 272
may also have hinged portions 274 and 276, respectively. Hinged
portions 274 and 276 may have a mold-in, living hinge-like detail
that has over-center memory or biasing, for example, which may be
hinged similar to the gas input tubes found on beach balls. Thus,
spacers 270 and 272 may be extended, as shown in FIG. 44b, or may
be partially collapsed on itself, as shown by spacer 270 in FIG.
44c. Alternatively, spacers 270 and 272 may be hinged in any other
manner known to a person having ordinary skill in that art. Spacers
270 and 272 may also have flanges 278 and 280, respectively, which
may be coupled with flanges 282 and 284. Flanges 282 and 284 are
associated with openings 286 and 288, respectively, of cushion
268.
[0122] In a further embodiment shown in FIG. 44b, nasal pillow 260,
spacer 270 and cushion 268 are shown as separate, in a cutaway
view. Nasal pillow 262, however, may use flange 266 to couple with
upper flange 275 of spacer 272. Lower flange 280 of spacer 272 may
then be coupled with flange 284 of cushion 268, so as to allow gas
to flow from a ventilation interface, through spacer 272 and
through nasal pillow 262. In the exemplary embodiment shown in FIG.
44b, hinge 276 of spacer 272 is shown in an upright, elongated
fashion.
[0123] In exemplary FIG. 44c, the orientation of nasal pillow 262,
spacer 272 and cushion 268 remains similar to that shown in FIG.
44b. Nasal pillow 260, however, may use flange 264 to couple with
upper flange 273 of spacer 270. Lower flange 278 of spacer 270 may
then be coupled with flange 282 of cushion 268, so as to allow gas
to flow from a ventilation interface, through spacer 270 and
through nasal pillow 260. Additionally, in the exemplary embodiment
shown in FIG. 44c, hinge 274 of spacer 270 is shown in a collapsed
fashion. Thus, the height of nasal pillow 260 may be varied through
the collapsing or elongating of hinge 274. Additionally, the height
of nasal pillow 262 may be varied through the collapsing or
elongating of hinge 276. Each of these hinges may be collapsed or
elongated in any of a variety of fashions known to a person having
ordinary skill in the art and each hinge may have an infinite range
of motion.
[0124] In another exemplary embodiment, the one or more nasal
pillows, for example nasal pillows 260 and 262, may be joined with
a cushion in any of a variety of manners. The nasal pillows 260 and
262 may be joined directly to a cushion, for example cushion 268.
Alternatively, nasal pillows 260 and 262 may be joined with a
spacer or spacers, for example spacers 270 and 272, respectively
that may then be joined with a cushion. The spacers may be in the
shape of a shroud that can then be joined with a cushion, may be
joined with a secondary piece that may then be joined with a
cushion, or may be joined in any other manner. In one embodiment,
the nasal pillows 260 and 262 may have threads, thus allowing the
nasal pillow to be threaded into a cushion, spacer or other
secondary piece. For example, by turning the pillow on the threads,
a user can adjust the pillow up or down within the range of the
threads. Additionally, a pillow may have female threads that thread
into male threads on a cushion, spacer or secondary piece or a
pillow may have male threads that thread into female threads on a
cushion, spacer or secondary piece. Additionally, if a spacer or
secondary piece is used to join the one or more nasal pillows to a
cushion, the spacer or secondary piece may have threading that is
designed to accept the one or more nasal pillows and may have
threading that may be used to adjustably connect the spacer or
secondary piece to the cushion.
[0125] In another exemplary embodiment, the spacer or spacers used
in any embodiment may be any shape. For example, the spacer may be
circular or oval. Additionally, the spacer may be constructed so as
to be either soft or rigid. Further, the spacer may be hollow so as
to allow for gas to travel through the spacer. Alternatively, the
spacer may be solid and have holes or slots disposed internally so
as to allow for the flow of gas from a cushion to a nasal
pillow.
[0126] Additionally, different spacers, such as spacers 270 and
272, may be utilized and interchanged. Spacers may be formed that
have a variety of different thicknesses. Also, spacers may be
formed with different elasticity, different stretching capabilities
or different flexibility. For example, different spacers may be
formed of different materials, thus giving the different spacers
different material properties and allowing for a wide range of
adjustments to be made for size, comfort and style, for
example.
[0127] In another exemplary embodiment, any of the spacers or
secondary pieces described herein, for example spacers 270 and 272
of FIG. 44, may be assembled and formed in any of a variety of
manners. For example, a spacer may be mechanically attached to a
nasal pillow or cushion, a spacer may be bonded to a nasal pillow
or a cushion or a spacer may be molded into a nasal pillow or
cushion. Additionally, any manner of attaching a spacer to a nasal
pillow or a cushion that is known to one of ordinary skill in the
art may be utilized.
[0128] In yet another embodiment, a nasal pillow in any of the
above exemplary embodiments, for example nasal pillow 260 or 262,
may be fitted or joined into a cushion or spacer in any of a
variety of manners. For example, a nasal pillow may press fit into
a cushion or spacer. Thus, a pillow may have straight or angled
walls and, when the pillow is being inserted into a cushion or
spacer, the friction between the walls of the pillow and the walls
of the cushion or spacer will act to provide a seal and maintain
the height of the nasal pillow. Additionally, a user may adjust the
height of the nasal pillow by pushing the nasal pillow down
further, and thereby lowering the height of the nasal pillow, or by
pulling the nasal pillow up, thus raising the height of the nasal
pillow.
[0129] In another exemplary embodiment shown in FIGS. 45a-b, one or
more nasal inserts may be oriented in additional positions on a
cushion. In FIG. 45a, a first nasal pillow 280 is shown as
separated from cushion 284, leaving opening 286 open and flange 288
unengaged. Nasal pillow 282 is shown as engaged to cushion 284
through the use of flange 290. Additionally, cushion 284 may have
edges that seal against the face, for example the upper lip, of a
user wearing the ventilation interface. In FIG. 45b a cutaway of
nasal pillow 282 engaged with cushion 284 is shown. Nasal pillow
282 may use flanges 292 to engage with flange 290 on cushion 284.
In the exemplary embodiment shown in FIG. 45b, the lower portion of
flanges 292 are used to engage nasal pillow 282 in cushion 284. In
alternative exemplary embodiments, any of the central or upper
flanges 292 may be utilized on nasal pillow 282. Further, in the
exemplary embodiment shown in FIG. 45b, cushion 284 has a membrane
300 that may seal against the upper lip of the user, and nasal
pillow 282 has a nasal insert portion 298 that may contact the
bottom of a nostril. The distance between a top edge 294 of
membrane 300 and a bottom edge 296 of nasal insert portion 298 may
be in the range of approximately 0.030'' to 2''.
[0130] Additionally, in further embodiments of the invention, one
nasal pillow may be connected to another nasal pillow using a
connecting member. The connecting member may be formed as part of a
nasal pillow and may be made out of any material and may join the
nasal pillows in any manner known to one having ordinary skill in
the art. The connecting member may also be removably attached to at
least one of the nasal pillows. A connecting member may be utilized
with any of the embodiments described herein and may maintain its
connection with each nasal pillows regardless of adjustment of the
height or angle of the nasal pillows. Additionally, the nasal
pillows may have thin portions that are designed to provide a place
for a connecting member to securely attach.
[0131] Any of the above embodiments may be utilized in any of a
variety of respiration or respiration assist devices and are not
limited to respiration assist masks. The various adjustable nasal
pillows, spacers and cushions, for example, may be utilized in any
of a variety of devices, including but not limited to respiration
assist masks, nasal cannulas, ventilation masks, underwater
breathing apparatuses, and other type of device capable of
delivering breathable gas or aerosol.
[0132] The foregoing description and accompanying drawings
illustrate the principles, preferred embodiments and modes of
operation of the invention. However, the invention should not be
construed as being limited to the particular embodiments discussed
above. Additional variations of the embodiments discussed above
will be appreciated by those skilled in the art.
[0133] Therefore, the above-described embodiments should be
regarded as illustrative rather than restrictive. Accordingly, it
should be appreciated that variations to those embodiments can be
made by those skilled in the art without departing from the scope
of the invention as defined by the following claims.
* * * * *