U.S. patent application number 12/099395 was filed with the patent office on 2008-08-07 for sealing nasal cannula.
Invention is credited to David J. Palkon, Geoffrey P. Sleeper.
Application Number | 20080185007 12/099395 |
Document ID | / |
Family ID | 34119107 |
Filed Date | 2008-08-07 |
United States Patent
Application |
20080185007 |
Kind Code |
A1 |
Sleeper; Geoffrey P. ; et
al. |
August 7, 2008 |
SEALING NASAL CANNULA
Abstract
An integrally molded ventilation interface includes a hollow
bellows-like structure and two nasal prongs extending from a top
surface of the bellows. A pair of headgear strap flanges can also
be molded integrally with the ventilation interface. The nasal
prongs provide a first sealing interface between an outer surface
of the nasal prongs and an inner surface of the patient's nares.
The bellows provides a second sealing interface between a top
surface of the bellows-like structure and a bottom surface of a
patient's nose. The headgear strap flanges provide a third sealing
interface between the ventilation interface and a mustache region
of the patient's face as well as a bottom surface of the patient's
nose.
Inventors: |
Sleeper; Geoffrey P.; (Bay
Village, OH) ; Palkon; David J.; (Tinley Park,
IL) |
Correspondence
Address: |
DICKE, BILLIG & CZAJA
FIFTH STREET TOWERS, 100 SOUTH FIFTH STREET, SUITE 2250
MINNEAPOLIS
MN
55402
US
|
Family ID: |
34119107 |
Appl. No.: |
12/099395 |
Filed: |
April 8, 2008 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10898872 |
Jul 26, 2004 |
7353826 |
|
|
12099395 |
|
|
|
|
60493515 |
Aug 8, 2003 |
|
|
|
Current U.S.
Class: |
128/207.18 |
Current CPC
Class: |
A61M 16/0816 20130101;
A61M 16/06 20130101; A61M 16/045 20140204; A61M 16/0611 20140204;
A61M 16/0825 20140204; A61M 16/0633 20140204; A61M 2205/0216
20130101; A61M 16/0666 20130101; A61M 16/0683 20130101; A61M
16/0833 20140204 |
Class at
Publication: |
128/207.18 |
International
Class: |
A61M 15/08 20060101
A61M015/08 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 27, 2004 |
US |
PCT/US04/24292 |
Claims
1. A ventilation interface comprising: a nasal cannula body, the
nasal cannula body comprising: a pair of nasal prongs located on a
top portion of the nasal cannula body to create a first sealing
interface between the nasal cannula body and a nose; and a
bellows-like structure integrally molded in a portion of the nasal
cannula body to create a second sealing interface between the nasal
cannula body and the nose.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/898,872, filed Jul. 26, 2004, which claims
priority under 35 U.S.C. .sctn.119(e)(1) to U.S. Provisional Patent
Application Ser. No. 60/493,515, filed Aug. 8, 2003; the entire
teachings of which are incorporated herein by reference.
FIELD
[0002] The present disclosure relates generally to ventilation
devices, and more particularly, to a nasal ventilation interface
for a continuous positive airway pressure system.
BACKGROUND
[0003] Sleep apnea is a potentially life-threatening breathing
disorder characterized by brief interruptions of breathing during
sleep. There are two types of sleep apnea: central and obstructive.
Central sleep apnea, which is less common, occurs when the brain
fails to send the appropriate signals to the breathing muscles to
initiate respirations. Obstructive sleep apnea occurs when air
cannot flow into or out of the person's nose or mouth although
efforts to breathe continue. In a given night, the number of
involuntary breathing pauses or "apneic events" may be as high as
20 to 60 or more per hour. Sleep apnea can also be characterized by
choking sensations. The frequent interruptions of deep, restorative
sleep often leads to excessive daytime sleepiness and may be
associated with an early morning headache. Early recognition and
treatment of sleep apnea is important because it may be associated
with irregular heartbeat, high blood pressure, heart attack, and
stroke.
[0004] Various forms of positive airway pressure during sleep can
be an effective form of therapy for the apnea sufferer. Ventilation
can be applied in the form of continuous positive airway pressure,
in which positive pressure is maintained in the airway throughout
the respiratory cycle; bi-level positive airway pressure system, in
which positive pressure is maintained during inspiration but
reduced during expiration; and intermittent (non-continuous)
positive pressure, in which pressure is applied when an episode of
apnea is sensed. In such procedures, a patient wears a mask over
the nose during sleep, and pressure from an air blower forces air
through the nasal passages. Typically, a thin flexible tube made of
an inert material transports the air. The tube terminates in an
opening that can be inserted into the patient's nostrils. A pair of
smaller nasal insert tubes can protrude from the tube or the tube
can split at a Y-junction into two smaller tubes, each smaller
nasal insert tube carrying gas to one nostril, thereby increasing
the fraction of inspired oxygen.
[0005] Conventional nasal tube systems do not provide a positive
seal between the nasal insert tubes and the nostrils. Most nasal
ventilation systems therefore include a mask that fits over the
nose and is intended to provide a space of oxygen-enriched air for
inhalation into the lungs for respiration. Such systems frequently
suffer from air leaking out around the mask, creating an inability
to assure ventilation in many patients. Additionally, most systems
are usually very position dependent, whereby if the mask is moved
slightly with respect to the facial contour or with respect to the
nose, air leakage occurs. With such systems, the mask can become
uncomfortable when not in position, thus requiring the patient to
remain rather still in order to alleviate the discomfort and to
maintain oxygen inspiration.
SUMMARY
[0006] The following presents a simplified summary of the
disclosure in order to provide a basic understanding of some
aspects of the disclosure. This summary is not an extensive
overview of the disclosure. It is intended to neither identify key
or critical elements of the disclosure nor delineate the scope of
the disclosure. Its sole purpose is to present some concepts of the
disclosure in a simplified form as a prelude to the more detailed
description that is presented later.
[0007] The present disclosure relates to a ventilation interface
for a continuous positive airway pressure system. According to a
first aspect of the present disclosure, a ventilation interface is
provided which includes a nasal cannula body. The nasal cannula
body includes a pair of nasal prongs located on a top portion of
the nasal cannula body to create a first sealing interface between
the nasal cannula body and a nose; and a bellows-like structure
integrally molded in a portion of the nasal cannula body to create
a second sealing interface between the nasal cannula body and the
nose.
[0008] According to another aspect of the present disclosure, a
ventilation interface is provided having a nasal cannula body; and
a pair of barrel shaped prongs located on a top portion of the
nasal cannula body, the barrel shaped prongs providing a large
sealing surface between an outer surface of the prongs and an inner
surface of a patient's nares.
[0009] According to yet another aspect of the present disclosure, a
ventilation interface is provided, the ventilation interface
including a nasal cannula body; and a pair of nasal prongs located
on a top portion of the nasal cannula body, the nasal prongs
comprising a thin wall that inflates under pressure to create a
sealing surface with nares of a patient.
[0010] According to yet another aspect of the present disclosure,
the ventilation interface includes means for creating a first
sealing interface between the ventilation interface and a patient's
nose; means for creating a second sealing interface between the
ventilation interface and the patient's nose; and means for
creating a third sealing interface between the ventilation
interface and the patient's nose.
[0011] According to yet another aspect of the present disclosure, a
method of manufacturing a ventilation interface is provided. The
method includes forming a nasal cannula body from a flexible
material; forming a pair of nasal prongs materially integrally with
the nasal cannula body; and forming a headgear strap materially
integrally with the nasal cannula body.
[0012] The following description and the annexed drawings set forth
in detail certain illustrative aspects of the disclosure. These
aspects are indicative, however, of but a few of the various ways
in which the principles of the disclosure may be employed and the
present disclosure is intended to include all such aspects and
their equivalents. Other objects, advantages and novel features of
the disclosure will become apparent from the following detailed
description of the disclosure when considered in conjunction with
the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 illustrates a perspective view of a nasal ventilation
interface in accordance with an aspect of the present
disclosure.
[0014] FIG. 2 illustrates a front view of a swivel component in
accordance with an aspect of the present disclosure.
[0015] FIG. 3 illustrates a perspective view of the nasal cannula
body employed in the nasal ventilation interface of FIG. 1 in
accordance with an aspect of the present disclosure.
[0016] FIG. 4 illustrates another perspective view of the nasal
cannula body employed in the nasal ventilation interface of FIG. 1
in accordance with an aspect of the present disclosure.
[0017] FIG. 5 illustrates a perspective view of another nasal
cannula body in accordance with an aspect of the present
disclosure.
[0018] FIG. 6 illustrates a perspective view of another nasal
cannula body in accordance with an aspect of the present
disclosure.
[0019] FIG. 7 illustrates a perspective view of a top portion of
the nasal cannula body of FIG. 6 in accordance with an aspect of
the present disclosure.
[0020] FIG. 8 illustrates a bottom view of the top portion of the
nasal cannula body of FIG. 6 in accordance with an aspect of the
present disclosure.
[0021] FIG. 9 illustrates a perspective view of a bottom portion of
the nasal cannula body of FIG. 6 in accordance with an aspect of
the present disclosure.
[0022] FIG. 10 illustrates another perspective view of the bottom
portion of the nasal cannula body of FIG. 6 in accordance with an
aspect of the present disclosure.
[0023] FIG. 11 illustrates a perspective view of another nasal
ventilation interface in accordance with an aspect of the present
disclosure.
[0024] FIG. 12 illustrates a front view of another nasal cannula
body in accordance with an aspect of the present disclosure.
[0025] FIG. 13 illustrates a perspective view of the nasal cannula
body of FIG. 12 in accordance with an aspect of the present
disclosure.
[0026] FIG. 14 illustrates a front view of another nasal cannula
body in accordance with an aspect of the present disclosure.
[0027] FIG. 15 illustrates a top view of the nasal cannula body of
FIG. 14 in accordance with an aspect of the present disclosure.
[0028] FIG. 16 illustrates a perspective view of another nasal
ventilation interface in accordance with an aspect of the present
disclosure.
[0029] FIG. 17 illustrates a perspective view of a nasal cannula
body employed in the nasal ventilation interface of FIG. 16 in
accordance with an aspect of the present disclosure.
[0030] FIG. 18 illustrates a perspective view of an elbow component
in accordance with an aspect of the present disclosure.
[0031] FIG. 19 illustrates an exploded view of the elbow component
of FIG. 18 in accordance with an aspect of the present
disclosure.
[0032] FIG. 20 illustrates a perspective view of a combination face
mask and nasal cannula body in accordance with an aspect of the
present disclosure.
[0033] FIG. 21 illustrates another perspective view of the
combination face mask and nasal cannula body of FIG. 20 in
accordance with an aspect of the present disclosure.
DETAILED DESCRIPTION
[0034] The present disclosure provides a nasal ventilation
interface having at least two sealing interfaces. The present
disclosure will now be described with reference to the drawings,
wherein like reference numerals are used to refer to like elements
throughout. It is to be appreciated that the various drawings are
not necessarily drawn to scale from one figure to another nor
inside a given figure, and in particular that the size of the
components are arbitrarily drawn for facilitating the reading of
the drawings. In the following description, for purposes of
explanation, numerous specific details are set forth in order to
provide a thorough understanding of the present disclosure. It may
be evident, however, that the present disclosure may be practiced
without these specific details.
[0035] Turning initially to FIG. 1, an example of a nasal
ventilation interface 100 in accordance with a first aspect of the
present disclosure is illustrated. The nasal interface 100
comprises a base portion 110 and a swivel component 120. The base
portion 110 includes a nasal cannula body 130 materially integral
with two supply tubes 140. The base portion 110 is manufactured
from one or more inert materials, such as polyurethane, silicone,
or the like. The supply tubes 140 are employed to deliver air
pressure from a ventilation device (not shown) to a patient via the
nasal cannula body 130. In particular, the ventilation device
forces a gas, such as air, through the supply tubes 140 and can be
provided by a continuous positive airway pressure machine, a
bi-level positive airway pressure machine, an intermittent
(non-continuous) positive pressure machine, or any other suitable
machine to deliver air to the patient.
[0036] For sleep apnea therapy, the ventilation device will usually
supply room air at a pressure of between five and fifteen
centimeters of water. The room air may be supplemented with oxygen
if desired by splicing an oxygen supply line into the supply hose
or using a triple port connector. It is normally unnecessary to
humidify or add moisture to the air supplied by the ventilation
device in using the nasal interface of the present disclosure, as
the nasal interface is designed to avoid stripping moisture from
the nares. Thus, moisture does not have to be added to relieve
patient discomfort from drying or burning sensations in the nasal
airways.
[0037] Each of the supply tubes 140 includes an end portion, which
is coupled to the swivel component 120 to facilitate easy
manipulation of the supply tubes 140 for patient comfort. Turning
now to FIG. 2, the swivel component 120 comprises a substantially
cylindrical element 122 for coupling with a tube of the ventilation
device and a hemispherical element 124 having two tubular engaging
portions 126 projecting therefrom. The two tubular engaging
portions 126 are utilized for coupling with end portions of the
supply tubes 140 of the ventilation interface 100. The cylindrical
element 122 and the hemispherical element 124 are operable to
swivel with respect to each other. For instance, the cylindrical
element 122 and the hemispherical element 124 can swivel about each
other by 360 degree. It is to be appreciated that any suitable
structure contemplated for swiveling the ventilation interface 100
with the tube of the ventilation device can be utilized.
[0038] Turning back to FIG. 1, the nasal interface 100 also
includes headgear strap flanges 150, which are coupled to the base
portion 110, to facilitate utilization of headgear straps (not
shown). Each of the headgear strap flanges 150 includes at least
one aperture 160 for receiving a portion of the headgear straps
therethrough. When nasal prongs of the nasal cannula body 130 are
inserted into nares of the patient, the headgear strap fastens
around the patient's head and applies backward pressure to the
nasal cannula body 130. A first sealing interface is thus created
via the headgear strap securing the nasal interface 100 against the
patient's mustache region. In addition to this backward pressure,
the flanges 150 are positioned in such a way that the headgear
strap applies an angular, upward pressure (e.g., approximately a
45-degree angle) to a bellows portion of the nasal cannula body
130, which will be described in further detail below. This angular,
upward pressure creates a second sealing interface between the
nasal cannula body 130 and the patient's nose.
[0039] The supply tubes 140 can be shaped to extend along a base of
the nasal cannula body 130 and bend downward near the headgear
strap flanges 150. As a result, the headgear straps support weight
and torque produced by the supply tubes 140, thereby decreasing the
chance of the supply tubes 140 disturbing a sealing means and
potentially breaking a seal between the ventilation interface 100
and the patient. Alternatively or additionally, the supply tubes
140 can be looped over the patient's ears.
[0040] Turning now to FIG. 3, the nasal cannula body 130 of the
ventilation interface 100 is shown in greater detail. The nasal
cannula body 130 is an arcuate, hollow body formed of a flexible
material, such as a silicone elastomer, for example. The nasal
cannula body 130 includes two substantially barrel-shaped nasal
prongs 210 projecting from a top surface 220 of the nasal cannula
body 130 and formed materially integrally therewith. The nasal
prongs 210 are hollow to form a continuous flow path, or conduit,
for passage of inhaled and exhaled gases between the patient's
nasal air passages and air chamber. Further, the nasal prongs 210
operably create a third sealing interface between the nasal prongs
210 and the patient's nares via the barrel-shaped structure. The
barrel shape is defined by a diameter of a central portion of the
nasal prongs 210 being greater than diameters at end portions of
the nasal prongs 210. Employing such a barrel shape structure
creates a large, even sealing surface when inserted into the
patient's nares. For instance, when inserted into the nares of the
patient, the barrel shape of each of the prongs 210 is compressed
in a radial direction such that a substantially uniform pressure is
applied across the outer surface of each of the prongs 210 and
against an inner surface of a respective naris, thus forming a
substantially airtight seal between the prong 210 and the naris
over a large surface area. The nasal prongs 210 also include a
center-to-center distance that corresponds to a center-to-center
distance between nares of an average user, such as about one
centimeter. It is to be appreciated that any suitable
center-to-center distance can be employed. Spacing the nasal prongs
210 by such a distance facilitates adjustment of the nasal
interface 100 for patient comfort.
[0041] A bellows-like structure (hereinafter referred to as
"bellows") 230 is integrally molded in the nasal cannula body 130
to create the second sealing interface between the nasal cannula
body 130 and the patient's nose. More specifically, the second
sealing interface is created between the top surface 220 of the
nasal cannula body 130 and a bottom, triangular shaped area of the
nose. The bellows 230 act in a manner similar to a compression
spring to apply a gentle upward pressure to the nose thereby
holding the sealing surfaces (e.g., the top surface of the bellows
230 and the bottom area of the nose) in sealing engagement with one
another. The bellows 230 is adjustable in length between a
contracted state and an expanded state.
[0042] FIG. 4 depicts a bottom perspective view of the nasal
cannula body 130. The nasal cannula body 130 further includes at
least one bleeder port 310 projecting from a bottom surface 320 of
the cannula body 130. In the example illustrated in FIG. 4, two
bleeder ports 310 are utilized and are axially aligned with the
nasal prongs 210. The bleeder ports can be cylindrical and have an
internal diameter of about three millimeters and a length of about
0.25 inches, for example. The internal diameter of the bleeder
ports 310 are ample to permit venting of carbon dioxide exhaled by
the patient while not being so large as to cause a significant
pressure drop in the cannula body 130. The axial alignment of the
bleeder port 310 with the nasal prongs 210 creates a direct path
for venting of the expired gases. At substantially the same time,
laminar flow of air supplied by the supply tubes is normal to the
bleeder ports 310, such that air supplied by the ventilator must
bend about ninety degrees to exit through the bleeder ports 310.
The effect of this construction is that the bleeder ports 310 are
virtually silent in operation, mitigating a whistle noise
associated with bleeder holes in conventional ventilation
interfaces.
[0043] As illustrated in FIG. 4, the nasal cannula body 130 can
also includes a substantially straight-shaped back surface 330.
However, it is to be appreciated that the back surface 330 of the
nasal cannula body 130 can also include the bellows-like structure
formed in the front surface 230 of the nasal cannula body 130.
[0044] FIG. 5 illustrates an alternative nasal cannula body 400
that can be employed with a nasal ventilation interface, such as
any of those disclosed herein. Although not illustrated in detail,
the nasal cannula body 400 can include headgear strap flanges for
use in conjunction with headgear straps to create a first sealing
interface between the nasal cannula body 400 and the patient's
face. The headgear strap flanges can be configured in a manner
similar to that depicted and discussed with respect to FIG. 1. The
nasal cannula body 400 can also include a bellows structure 430 to
create a second sealing interface between a top portion of the
nasal cannula body 400 and a bottom portion of the patient's nose.
The bellows structure 430 operates in a manner similar to bellows
230, described above, and thus further description of the bellows
structure 430 will be omitted herein for the sake of brevity.
[0045] A third sealing interface is created by two nasal prongs 410
that project from the top portion of the nasal cannula body 400.
The nasal prongs 410 comprise a substantially straight-shaped,
hollow body having two or more rings 420 provided around an outer
surface thereof. For example, the nasal prongs 410 can include
three rings, as depicted in FIG. 4. In particular, the third
sealing interface is created between an outer surface of the rings
420 and an inner surface of a patient's nares when the nasal prongs
410 are inserted into a nose of a patient. It is to be appreciated
that the rings 420 can also be used in combination with the
barrel-shaped nasal prongs 210 described with respect to FIG.
3.
[0046] FIG. 6 illustrates another example of a nasal cannula body
500 in accordance with an aspect of the present disclosure. The
nasal cannula body 500 comprises a top housing portion 510 and a
bottom housing portion 520. The top housing portion 510 includes a
bellows structure 530 and two barrel-shaped nasal prongs 540
extending from a top surface 550 of the top housing portion 510.
The barrel-shaped nasal prongs 540 and the bellows 530 are employed
to create sealing interfaces between the nasal cannula body 500 and
a nose of a patient. When inserted into the nares of the patient,
the barrel shape of each of the prongs 540 is compressed in a
radial direction such that a substantially uniform pressure is
applied across its outer surface against an inner surface of a
respective naris, thus forming a substantially airtight seal
between the prong 540 and the naris over a large surface area.
Alternatively, or additionally, two or more rings formed on the
nasal prongs provide a sealing interface between the ring(s) and an
inner surface of the naris. The bellows 530 act in a manner similar
to a compression spring to apply a gentle upward pressure to a
bottom surface of the nose, thereby holding the top surface 550 of
the nasal cannula body 500 and the bottom area of the nose in
sealing engagement with each other.
[0047] The bottom housing portion 520 of the nasal cannula body 500
forms a base for the bellows 530 and includes one or more air
inlets 560 to which flexible air supply tubing (not shown) can be
attached. The inlets 560 extend from opposing side portions of the
nasal cannula body 500 in a direction angled towards the patient
when the nasal cannula body 500 is in use.
[0048] Turning now to FIGS. 7 and 8, the top housing portion 510 of
the nasal cannula body 500 is depicted in further detail. The top
housing portion 510 has an open end 610, which serves as an air
inlet, located opposite the top surface 550. Each of the
barrel-shaped nasal prongs 540 is hollow and has an outlet 710
(FIG. 7) through which air pressure from the open end 610 is
communicated to the patient. The top housing portion 510 further
includes the bellows 530 around a circumference of the nasal
cannula body 500. However, it is to be appreciated that the bellows
530 can be provided on only a front or back portion of the nasal
cannula body 500, if desired.
[0049] FIGS. 9 and 10 illustrate the bottom housing portion 520 of
the nasal interface 500, as described with respect to FIG. 5. The
bottom housing portion 520 includes a base portion 810 having an
open area 820 for receiving air from the one or more air inlets
560. The air inlet(s) 560 include an end portion 830 to which
flexible air supply tubing (not shown) can be attached. The air
supply tubing can be made of a relatively flexible adjustable
material, such as plastic or the like, and is employed as a conduit
for ventilation. The nasal interface 500 can include a Y-connector
having a first end adapted to receive a supply hose from a
mechanical ventilator (not shown) and a second end having a pair of
ports (not shown) with connectors for attachment to the air supply
tubing. It is to be appreciated that the Y-connector described with
respect to the present disclosure can alternatively be a
T-connector, or any other three-way tubing connector as is known in
the art. A swivel portion can also be coupled to the connector to
facilitate easy manipulation of the tubing for patient comfort.
[0050] Although not illustrated, it is to be appreciated that a
headgear strap or a flange for a headgear strap can be coupled to
the bottom housing portion 520 to provide an additional sealing
interface. The headgear strap can fasten around the patient's head
to apply backward pressure to the nasal cannula body 500, thereby
securing it against the patient's mustache region. Also, the
headgear applies an angular, upward pressure, at approximately a
45-degree angle, to the bellows 530. The spring-like feature of the
bellows 530 partially absorbs this angular, upward pressure and
applies gentle pressure to the bottom of the nose, thereby forming
an airtight seal between the top surface 550 of the nasal cannula
body 500 and the bottom of the patient's nose.
[0051] Turning now to FIG. 11, yet another example of a nasal
ventilation interface 1000 is illustrated in accordance with
another aspect of the present disclosure. The nasal ventilation
interface 1000 includes a nasal cannula 1010 that provides at least
two sealing interfaces between the nasal cannula 1010 and a
patient's nose. Nasal prongs 1020, which are located on a top
surface 1030 of the nasal cannula 1010, form one sealing interface.
The nasal prongs 1020 can include a substantially barrel shaped
structure for providing a sealing interface between an outer
surface of the prongs and the inner nares of the patient.
Alternatively, the nasal prongs can include a plurality of rings
(not shown) formed thereon to provide a sealing interface between
the rings and the inner nares of the patient. The other sealing
interface is formed between the top surface 1030 of the nasal
cannula 1010 and the bottom surface of the patient's nose by
employing a bellows structure 1040 in conjunction with a headgear
strap, as described herein. The nasal ventilation interface 1000
also includes air supply tubing 1050 to provide air to the patient
via the nasal cannula. The tubing 1050 can be coupled to headgear
strap flanges 1060 or can be configured to wrap around the
patient's ear.
[0052] FIGS. 12 and 13 depict yet another nasal cannula design 1100
in accordance with an aspect of the present disclosure. The nasal
cannula 1100 includes at least one headgear strap flange 1130
materially integrally formed with the nasal cannula body 1100 to
provide a first sealing interface. It is to be appreciated that the
headgear strap flange 1130 can be coupled to tubes of the nasal
cannula in any conventional manner. The headgear strap flange 1130
includes a first aperture 1140 for allowing air supply tubing to
pass therethrough and a second aperture 1150 for receiving the
headgear strap. Moreover, the flange(s) 1130 is configured such
that the headgear strap secures the nasal cannula 1100 to the
patient in at least two different planes: up and towards the face.
The nasal cannula body 1100 further includes a bellows like
structure 1120 to provide a second sealing interface between the
nasal cannula body 1100 and a bottom portion of the patient's nose.
Further still, the nasal cannula body 1100 includes barrel shaped
nasal prongs 1110 for providing a third sealing interface between
an inner surface area of the patient's nose and the nasal prongs
1110.
[0053] FIGS. 14 and 15 illustrate another alternative nasal cannula
body 1300 that can be employed with any of the nasal ventilation
interfaces disclosed herein. The nasal cannula body 1300 is shaped
such that it substantially conforms to contours of a patient's
mustache region (see FIG. 15) and includes three sealing
interfaces. One sealing interface is created by two nasal prongs
1310 projecting from a top surface of the nasal cannula body 1300.
The nasal prongs 1310 have thin, ribbed walls, which are adapted to
inflate under pressure. For example, the nasal prongs 1310 can be
easily and comfortably inserted into a nose of a patient in a
compressed state, as illustrated in FIGS. 14 and 15. Then, when a
gas flows through the ventilation interface via a CPAP machine, for
example, the nasal prongs 1310 can inflate to create an air tight
sealing surface between the outer surface of the nasal prongs 1310
and the nares of the patient. The nasal prongs 1310 can assume a
barrel-shaped structure when inflated to provide a large, even
sealing surface in the nares. However, it is to be appreciated that
the nasal prongs 1310 can assume any suitable shape when inflated
to provide maximum sealing between the prongs 1310 and the
nares.
[0054] Another sealing interface is created by a bellows-like
structure 1320 formed on a front portion of the nasal cannula body
1300. The bellows-like structure 1320 operates to apply a gentle
upward pressure to the nose such that a top surface of the nasal
cannula body 1300 is held in sealing engagement with a bottom
surface of a nose. The bellows 1320 is adjustable in length between
a contracted state and an expanded state. It is to be appreciated
that the bellows can additionally, or alternatively, be located on
a back portion of the nasal cannula body 1300.
[0055] Integral headgear strap flanges 1330 create yet another
sealing interface. The headgear strap flanges 1330 are located at
an angle suitable to provide a backward pressure to secure the body
1300 against the patient's mustache region in addition to an upward
pressure to secure the body 1300 against the patient's nose. For
example, the headgear strap flanges 1330 can be located at
approximately a 45-degree angle with respect to a central axis of
inlet ports 1340 located on the nasal cannula body 1300. The
spring-like feature of the bellows 1320 partially absorbs this
upward pressure and applies gentle pressure to the bottom the nose,
thereby, forming an airtight seal between the top surface of the
nasal cannula body 1300 and the bottom of the patient's nose.
[0056] Turning now to FIG. 16, another example of a nasal
ventilation interface 1600 is depicted in accordance with an aspect
of the present disclosure. The nasal ventilation interface 1600
includes three different sealing interfaces and three different
swivel points for patient comfort. The nasal ventilation interface
1600 includes a nasal cannula body 1610 that is connected to a
ventilation device (not shown) via at least one supply tube 1620. A
first swivel component 1630 is utilized to couple the at least one
supply tube 1620 with a ventilation device supply tube (not shown).
The first swivel component 1630 is similar in construction to the
swivel component described with respect to FIG. 2 herein and thus
will not be described further for the sake of brevity.
[0057] FIG. 17 illustrates the nasal cannula body 1610 in greater
detail. A first sealing interface of the nasal ventilation
interface 1600 is created by at least one headgear strap flange
1650, which can be formed materially integrally with the nasal
cannula body 1610. The headgear strap flange(s) 1650 includes at
least one slot 1655 formed therein for securing the headgear strap
thereto. Due to the configuration of the headgear strap flange
1650, the headgear strap, when worn by the patient, applies a
backward pressure to the nasal cannula body 1610. The first sealing
interface is thus created between the nasal cannula body 1610 and
the patient's mustache region. In addition to this backward
pressure, the flange(s) 1650 is positioned in such a way that the
headgear strap applies an angular, upward pressure (e.g.,
approximately a 45-degree angle) to a bellows portion 1670 of the
nasal cannula body 1610, which will be described in further detail
below. This angular, upward pressure creates a second sealing
interface between a top surface of the nasal cannula body 1610 and
a bottom surface of the patient's nose.
[0058] A third sealing interface is created by a pair of nasal
prongs 1660 projecting from a top surface of the nasal cannula body
1610. The nasal prongs 1660 include a bulbous base portion that
tapers into a substantially straight top portion. The nasal prongs
1660 are inserted into the nares of the patient such that the
bulbous base portion of the nasal prongs 1660 creates a
substantially airtight seal between an outer surface area of the
base portion and an inner surface area of the nares. At least one
bleeder port 1680 projects from a bottom surface of the nasal
cannula body 1610.
[0059] The nasal cannula body 1610 further comprises at least one
inlet for receiving gas from the supply tube(s) 1620. In the
illustrated example, the nasal cannula body 1610 includes two
inlets coupled to two supply tubes 1620. Two swivel elbows 1800 are
also included to provide an airtight coupling between the nasal
cannula body 1610 and the supply tubes 1620, as well as, to provide
an additional swivel feature to the nasal ventilation interface
1600. The swivel elbows 1800 swivel about an axis parallel to a
central axis of the inlet ports; thereby, allowing the supply tubes
1620 to swivel 360 degree about the nasal cannula body 1610. Thus,
the patient can wear the nasal ventilation interface 1600 with the
supply tubes 1620 down towards their chest or above their head.
Further, the swivel elbows 1800 allow the nasal cannula body 1610
to self-adjust to a correct angle for nasal prong insertion in both
the downward and over the head positions.
[0060] The swivel elbows 1800 are illustrated in further detail in
FIGS. 18 and 19. The swivel elbows 1800 can be manufactured from a
rigid plastic material, or any other suitable material, and include
an elbow component 1810, a swivel connector 1820, and a locking
collar 1830. The swivel connector 1820 fits over an end portion of
the elbow component 1810. The locking collar 1830 snaps over a
portion of the swivel connector 1820 such that at least one small
protrusion (not shown) on the locking collar 1830 projects through
a corresponding aperture on the swivel connector 1820 to make
contact with the elbow component 1810, thereby locking the three
components 1810, 1820, and 1830 together. The swivel connector 1820
and the locking collar 1830 are then operable to rotate about the
end portion of the elbow component 1810. It is to be appreciated
that any suitable size and shape swivel component can be employed
to couple at least one supply tube to the nasal cannula body and is
contemplated as falling within the scope of the present
disclosure.
[0061] FIGS. 20 and 21 illustrate yet another example of a nasal
ventilation device 2000. The nasal ventilation device 2000 is a
hybrid of a nasal cannula body portion 2010 and a face mask portion
2020. The nasal cannula body portion 2010 includes a pair of nasal
prongs 2030 for insertion into a patient's nares. The nasal prongs
2030 can include a bulbous-shaped base portion to facilitate
providing an airtight seal between an outer surface of the nasal
prongs 2030 and an inner surface of the patient's nares. The
bulbous-shaped base portion includes a large sealing surface area
to mitigate internal pressure points between the nasal prongs 2030
and the nares, thereby mitigating nasal irritation in the patient.
Moreover, when gas flows through the nasal prongs 2030, the nasal
prongs 2030 are adapted to expand to further seal the nasal prongs
2030 within the nares. The bulbous-shaped base portion of the nasal
prongs 2030 tapers into a straight-shaped end portion. It is to be
appreciated that the nasal prongs 2030 can be of any suitable shape
for providing a sealing interface between the prongs and the
patient's nares. For example, the nasal prongs 2030 can be
barrel-shaped. At least one inlet 2070 is included on the nasal
cannula body portion 2010 for receiving the gas from the
ventilation device (not shown).
[0062] The nasal cannula body portion 2010 further includes a
bellows 2040 formed within the nasal cannula body portion 2010 to
facilitate sealing between a top surface of the nasal cannula body
portion 2010 and a bottom surface of a patient's nose. Headgear
strap flanges 2050 are also integrally formed with the nasal
cannula body portion 2010 to facilitate yet another sealing
interface between the nasal cannula body portion 2010 and the
patient. The headgear strap flanges 2050 each include at least one
aperture, and in this example, each of the headgear strap flanges
2050 includes two apertures 2060 and 2065. The apertures 2060 and
2065 receive headgear straps, which are then fastened around the
patient's head. The position of the headgear strap flanges 2050, as
well as the positions of the apertures 2060 and 2065, pull the
nasal cannula body portion 2010 backwards and upwards towards the
patient's face to create a sealing interface between a back portion
of the nasal cannula body 2010 and the patient's mustache
region.
[0063] The face mask portion 2020 of the ventilation device 2000
includes an elastomeric material and is shaped so as to fit the
contours of a patient's face around a mouth area of the patient.
The face mask portion 2020 also includes headgear strap flanges
2110 formed integrally with the mask 2020 to facilitate sealing of
the mask against the patient's face. The headgear strap flanges
2110 each include at least one aperture 2120 for receiving headgear
straps. The face mask portion 2020 further includes at least one
bleeder port 2100 and an anti-asphycsia valve 2090.
[0064] Due to the three different sealing means of a nasal
ventilation interface, as described with respect to the plurality
of embodiments described herein, an adequate seal is provided with
minimal pressure concentration being applied to the patient's nose
and face; thereby, mitigating mucosal irritation. Accordingly,
effectiveness as well as comfort of the nasal ventilation interface
is achieved.
[0065] Although a detailed description of a preferred embodiment of
this disclosure has been shown and described hereinabove, it will
be understood that various modifications and rearrangements of the
parts and their respective features may be resorted to without
departing from the scope of the disclosure as disclosed herein.
* * * * *