U.S. patent application number 16/276674 was filed with the patent office on 2019-06-20 for face mask.
The applicant listed for this patent is RIC INVESTMENTS, LLC. Invention is credited to ROBERT HIEBER, CHRISTOPHER JAMES MCCRACKEN, JONATHAN P. TODD.
Application Number | 20190184126 16/276674 |
Document ID | / |
Family ID | 40336932 |
Filed Date | 2019-06-20 |
View All Diagrams
United States Patent
Application |
20190184126 |
Kind Code |
A1 |
TODD; JONATHAN P. ; et
al. |
June 20, 2019 |
FACE MASK
Abstract
A mask assembly is provided for delivering gas to a patient that
includes a mask body and a breathing circuit interface. The mask
body includes an opening for reception of the gas and includes a
seal structure for sealingly engaging with the face of the patient
and surrounding at least the nose and mouth of the patient. The
breathing circuit interface includes a first portion rotatably
connected with the mask body and a second portion that is
constructed and arranged to releasably connect with a conduit for
delivering the gas to the patient through the opening.
Inventors: |
TODD; JONATHAN P.;
(MURRYSVILLE, PA) ; MCCRACKEN; CHRISTOPHER JAMES;
(HARRISON CITY, PA) ; HIEBER; ROBERT; (EXPORT,
PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RIC INVESTMENTS, LLC |
Wilmington |
DE |
US |
|
|
Family ID: |
40336932 |
Appl. No.: |
16/276674 |
Filed: |
February 15, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15169024 |
May 31, 2016 |
10245405 |
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16276674 |
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14048120 |
Oct 8, 2013 |
9375544 |
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15169024 |
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12742950 |
May 14, 2010 |
8573217 |
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PCT/IB08/54722 |
Nov 11, 2008 |
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14048120 |
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60987843 |
Nov 14, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0858 20140204;
A61M 16/1045 20130101; A61M 16/0875 20130101; A61M 16/208 20130101;
A61M 16/1065 20140204; A61M 16/0463 20130101; A61M 2016/0027
20130101; A61M 16/06 20130101; A61M 16/0816 20130101; A61M 16/16
20130101; A61M 16/0057 20130101; A61M 16/209 20140204; A61M 16/0415
20140204; A61M 16/0825 20140204; A61M 16/0683 20130101; A61M
2230/432 20130101; A61M 16/0616 20140204; A61M 2205/0244 20130101;
A61M 15/009 20130101; A61M 2209/06 20130101 |
International
Class: |
A61M 16/06 20060101
A61M016/06; A61M 16/10 20060101 A61M016/10; A61M 16/08 20060101
A61M016/08; A61M 16/20 20060101 A61M016/20; A61M 16/04 20060101
A61M016/04; A61M 15/00 20060101 A61M015/00; A61M 16/00 20060101
A61M016/00 |
Claims
1. A mask assembly for providing gas to a patient, comprising: a
mask body having an opening for reception of the gas, the mask body
including a seal structure for sealingly engaging with the face of
the patient and surrounding at least the nose and mouth of the
patient, the mask body having a connecting portion; and a conduit
releasably connected with the connecting portion of the mask body
for delivering the gas to the patient through the opening, the
conduit comprising a first connector portion which connects with
the connecting portion, and a second connector portion constructed
and arranged to connect with tubing, wherein the first connector
portion comprises a plurality of recesses at an interface with the
connecting portion to allow exhaled gas to escape therethrough.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a Continuation under 35 U.S.C.
.sctn. 120/121 of U.S. patent application Ser. No. 15/169,024,
filed May 31, 2016, which is a Continuation under 35 U.S.C. .sctn.
120/121 of U.S. patent application Ser. No. 14/048,120, filed Oct.
8, 2013, now U.S. Pat. No. 9,375,544, granted Jun. 28, 2016, which
is a Continuation under 35 U.S.C. .sctn. 120/121 of U.S. patent
application Ser. No. 12/742,950, filed May 14, 2010, now U.S. Pat.
No. 8,573,217, granted Nov. 5, 2013, which claims the priority
benefit under 35 U.S.C. .sctn. 119(e) of U.S. Provisional
Application No. 60/987,843 filed on Nov. 14, 2007, the contents of
which are herein incorporated by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates to therapeutic gas delivery
systems and, more particularly, to a mask that forms a seal with a
patient's face during gas delivery.
2. Description of the Related Art
[0003] One class of respiratory face mask assemblies can be of two
different types: a single limb circuit type and a dual limb circuit
type. For a single limb circuit, the face mask assembly typically
includes a valve and an exhaust port, and, for a dual limb circuit,
the face mask assembly typically does not include a valve but
provides a valveless conduit instead. Other types of masks may also
be useful for different applications. Thus, hospitals and other
health care facilities typically stock several different types of
face mask assemblies that are used for different applications. Cost
and storage space considerations associated with stocking several
different face mask assemblies can be significant.
SUMMARY OF THE INVENTION
[0004] One aspect of the present invention provides a mask assembly
for providing gas to a patient. The mask assembly includes a mask
body having an opening for reception of the gas and a breathing
circuit interface. The mask body includes a seal structure for
sealingly engaging with the face of the patient and surrounding at
least the nose and mouth of the patient. The breathing circuit
interface includes a first portion rotatably connected with the
mask body and a second portion that is constructed and arranged to
releasably connect with a conduit for delivering the gas to the
patient through the opening.
[0005] Another aspect of the present invention provides a mask
assembly for providing gas to a patient. The mask assembly includes
a mask body having an opening for reception of the gas and a
conduit. The mask body includes a seal structure for sealingly
engaging with the face of the patient and surrounding at least the
nose and the mouth of the patient, and a connecting portion. The
conduit is releasably connected with the connecting portion of the
mask body. The conduit includes a first connector portion which
connects with the connecting portion, and a second connector
portion that is constructed and arranged to connect with tubing,
wherein the first connector portion includes a plurality of
recesses at an interface with the connecting portion to allow
exhaled gas to escape therethrough.
[0006] In yet another embodiment, the present invention provides a
mask assembly kit for providing gas to a patient. The mask assembly
kit includes a mask body having an opening for reception of the
gas, a first, valveless conduit, and a second conduit containing a
valve. The mask body includes a seal structure for sealingly
engaging with the face of the patient and surrounding at least the
nose and the mouth of the patient. Each of the conduits includes a
first connector portion which connects with a connecting portion
associated with the mask body, and a second connector portion
constructed and arranged to connect with tubing. The connecting
portion of the mask body is constructed and arranged to be
selectively attached to the first connector portion of either the
first conduit or the second conduit.
[0007] These and other aspects of the present invention, as well as
the methods of operation and functions of the related elements of
structure and the combination of parts and economies of
manufacture, will become more apparent upon consideration of the
following description and the appended claims with reference to the
accompanying drawings, all of which form a part of this
specification, wherein like reference numerals designate
corresponding parts in the various figures. It is to be expressly
understood, however, that the drawings are for the purpose of
illustration and description only and are not intended as a
definition of the limits of the invention. As used in the
specification and in the claims, the singular form of "a", "an",
and "the" include plural referents unless the context clearly
dictates otherwise.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1A is a perspective view of the mask assembly and
patient's face in accordance with an embodiment of the present
invention;
[0009] FIG. 1B is a left side perspective view of the mask assembly
and patient's face in accordance with an embodiment of the present
invention;
[0010] FIG. 2 is a perspective view of the mask assembly with an
entrainment valve assembly in accordance with an embodiment of the
present invention;
[0011] FIG. 3 is a perspective exploded view of a mask assembly in
accordance with an embodiment of the present invention;
[0012] FIG. 4 is an upper right perspective view of an air
entrainment valve with exhaust ports assembly in accordance with an
embodiment of the present invention;
[0013] FIG. 5 is a left side perspective view of the air
entrainment valve with exhaust ports assembly in accordance with an
embodiment of the present invention;
[0014] FIG. 6 is a cross-sectional view of the mask assembly in
accordance with an embodiment of the present invention;
[0015] FIG. 7 is a cross-sectional view of the entrainment valve
assembly in accordance with an embodiment of the present
invention;
[0016] FIG. 8 is a perspective view of a valve element in
accordance with an embodiment of the present invention;
[0017] FIG. 9 is a top perspective view of a valve element in
accordance with an embodiment of the present invention;
[0018] FIG. 10 is a perspective view of the mask body and the
entrainment valve assembly in accordance with an embodiment of the
present invention;
[0019] FIG. 11 is a perspective view of the mask body and a
standard elbow before the assembly in accordance with an embodiment
of the present invention;
[0020] FIG. 12 is a perspective view of the mask body and the
standard elbow after the assembly in accordance with an embodiment
of the present invention;
[0021] FIG. 13 is a rear perspective view of the mask assembly in
accordance with an embodiment of the present invention;
[0022] FIG. 14 is a front perspective view of a mask headgear
attachment post in accordance with an embodiment of the present
invention;
[0023] FIG. 15 is a rear perspective view of the mask headgear
attachment post in accordance with an embodiment of the present
invention;
[0024] FIG. 16 is a side perspective view of the mask headgear
attachment post in accordance with an embodiment of the present
invention;
[0025] FIG. 17 is a rear perspective view of a mask headgear
attachment clip in accordance with an embodiment of the present
invention;
[0026] FIG. 18 is a front perspective view of the mask headgear
attachment clip in accordance with an embodiment of the present
invention;
[0027] FIG. 19 is a cross-sectional view taken through the line A-A
in FIG. 6 and showing the passage of the exhalation grooves through
the breathing circuit interface in accordance with an embodiment of
the present invention;
[0028] FIG. 20 is a front perspective view of an alternative
embodiment of the mask assembly;
[0029] FIG. 21 is an exploded front perspective of the mask
assembly in accordance with an embodiment of the present
invention;
[0030] FIG. 22 is a front perspective of an alternative mask
headgear attachment clip in accordance with an embodiment of the
present invention; and
[0031] FIG. 23 is a rear perspective of an alternative mask
headgear attachment clip in accordance with an embodiment of the
present invention.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0032] FIGS. 1A, 1B, 2 and 3 show a mask assembly 10 for use in a
therapeutic gas delivery in accordance with an embodiment of the
present invention. The mask assembly 10 may generally include a
mask body 12 having an opening 13 for reception of gas. The mask
body 12 includes a seal structure 20 for sealingly engaging with
the face of the patient 27 in surrounding relation to at least the
nose and mouth (and optionally the eyes) of the patient 27. The
mask assembly 10, in one embodiment, also includes a breathing
circuit interface 16 for connecting the mask body 12 with a
pressurized breathing gas supply. As disclosed in more detail
later, the breathing circuit interface 16 has a first portion 17
rotatably connected with the mask body 12 and a second portion 19
constructed and arranged to connect with a conduit 18 for
delivering the gas to the patient 27 through the opening 13.
[0033] In an embodiment, the breathing circuit interface 16 and the
conduit 18 connects the mask body 12, via a circuit tubing (not
shown), to a source of gas (not shown), e.g., a blower, a CPAP
machine, a ventilator or other suitable device, for providing
breathing gas to the patient 27. As will be appreciated from
further discussions herein, the second portion 19 of the breathing
circuit interface 16 is releasably connected with the conduit 18 to
enable different types of conduits 18 to be connected to the mask
body 12. In addition, a rotatable or swivel connection between the
breathing circuit interface 16 at the first portion 17 thereof with
the mask body 12 allows the elbow shaped conduit 18 to rotate after
connection to enable the conduit 18 to extend in any direction
within a 360.degree. of rotation for connecting with the tubing. It
should be appreciated that for some purposes the breathing circuit
interface 16 may also be considered to be part of the mask body
12.
[0034] As shown in FIG. 3, the breathing circuit interface 16 has
an annular configuration with a generally cylindrical inner surface
23 disposed about a central opening 29 therethrough. As will be
appreciated from more detailed discussions later, the cylindrical
inner surface 23 of the breathing circuit interface 16 is shaped
and configured to provide a releasable friction fit with a
generally cylindrical mating surface 25 of an appropriate conduit
18 that connects with tubing for receiving a breathable gas.
[0035] A plurality of radially outwardly extending ribs 31, which
have an increasing thickness or radial dimension as they extend
from the second portion 19 to the first portion 17 of the breathing
circuit interface 16, are spaced at regular circumferential
intervals. The ribs 31 are integrally formed as part of the outer
surface of the breathing circuit interface 16. The plurality of
ribs 31 located on the outer surface of the second portion 19 of
the breathing circuit interface 16 provides the user 27 (or
healthcare personnel) a grip to hold the breathing circuit
interface 16 when connecting and disconnecting the conduit 18 to
the breathing circuit interface 16. The ribs 31 also facilitate
manual rotation of the breathing circuit interface 16.
[0036] In one embodiment, the mask body 12 includes a rigid portion
21, formed from a clear plastic material, and the aforementioned
flexible peripheral seal structure 20. The flexible peripheral seal
structure 20 is attached around the rigid portion 21 of the mask
body 12. A protrusion 60 extends forwardly from a forward central
portion of the rigid portion 21 of the mask body 12 and is shaped
to accommodate the nose and the mouth of the patient 27. The
protrusion 60 is generally pear shape about its periphery 62, where
it meets the flatter parts 64 of the rigid portion 21 and includes
the opening 13 located in the forwardmost portion thereof. The
protrusion 60 includes a pair of indentations 68 located
horizontally on either side of the opening 13. The pair of
indentations 68 serves as finger receiving indentations and
provides a region for an individual to grip the mask body 12 when
placing and removing the mask body 12 on the patient's face.
[0037] In one embodiment, the mask body 12 is adapted to be
connected with headgear assembly 11 that can be used to mount the
mask body 12 on the head of the patient 27. In an embodiment, a
pair of headgear attachment clips 14 provided for interface and
connection with lower headgear mounting strap portions 40 of the
headgear assembly 11. A pair of headgear attachment members 22 is
provided for connectably receiving the headgear attachment clips
14, and a pair of spaced upper headgear strap retaining tabs 24,
each having an elongated opening 50 therethrough, is provided for
receiving upper headgear mounting strap portions 40 of the headgear
assembly 11. The pair of headgear retaining tabs 24 is disposed on
the opposite upper sides of the rigid portion 21 of the mask body
12. The pair of headgear attachment members 22 is disposed on
opposite, lower sides of the rigid portion 21 of the mask body 12.
Each headgear retaining tab 24 is integrally formed with rigid
portion 21 and extends outwardly from the flexible peripheral seal
structure 20, as best seen in FIGS. 2 and 3.
[0038] FIG. 4 shows a conduit 18 in accordance with one embodiment.
In this embodiment, the conduit 18 is an entrainment valve assembly
200. The entrainment valve assembly 200 comprises a generally an
elbow shaped tubular member 201 formed from a rigid plastic
material, such as polycarbonate or other plastic material as would
be appreciated by one skilled in the art. In one embodiment, the
tubular member 201 is formed from a clear, colorless, plastic
material. Tubular member 201 includes a primary inlet 202, a
secondary inlet 204 and an outlet 206.
[0039] Tubular member 201 includes a first connector portion 230
and a second connector portion 232. The first connector portion 230
and the second connector portion 232 are generally cylindrical in
shape and are generally disposed perpendicular to each other. The
first connector portion 230 and second connector portion 232 is
joined by a bent tubular region 233. The first connector portion
230 has aforementioned generally cylindrical outer surface 25 for
connection with the breathing circuit interface 16, while the
second connector portion 232 also has a cylindrical outer surface
205 for frictionally mating with the inner surfaces of tubing.
[0040] The second connector portion 232 is connected to the
breathing circuit tubing (not shown) and receives pressurized gas
from a source of pressurized gas (e.g., air from a CPAP machine, a
blower, a ventilator or other ventilation device).
[0041] The secondary inlet 204 of the entrainment valve assembly
200 comprises an opening 254 located towards the bent tubular
region 233. The opening 254 is divided into two equal, generally
semi-cylindrical segments by a planar wall 256. The planar wall 256
of the entrainment valve assembly 200 extends through the
cylindrical opening 254. The opening 254 allows the user 27 to
breath in from and out to atmosphere in the absence of pressurized
gas flow being provided into inlet 202. The entrainment valve
assembly 200, at cylindrical surface 25, further includes a
plurality of exhalation grooves 258. The grooves 258 are located at
an interface where the entrainment valve assembly 200 connects with
the breathing circuit interface 16 as will be more fully
appreciated from FIG. 19. The plurality of the exhalation grooves
258 are circumferentially spaced on surface 25 and placed
symmetrically on either side of the first connector portion 230.
Other embodiments are contemplated in which the exhalation grooves
258 are located anywhere on the outer surface of the first
connector portion 230, where it interfaces with breathing circuit
interface 16.
[0042] As clearly shown in FIG. 3, the four exhalation grooves 258
on each side of the entrainment valve tubular member 201 are placed
at an angle with respect to the horizontal axis on the surface 25
of the entrainment valve 200. Specifically, when the tubular member
201 is connected to the rigid portion 21 such that the second
connector portion 232 of the tubular member 201 points downwards,
the four exhalation grooves 258 on one side of the tubular member
201 point upwards at an angle whereas the four exhalation grooves
258 on the other side of the tubular member 201 point downwards at
an angle. The angular positioning of the grooves 258 allows the
exhaled gas to exit the mask in a swirling motion. In addition, the
angled groove 258 aid in providing a releasable friction fit
between the cylindrical mating surface 25 of the entrainment valve
assembly 200 and the cylindrical inner surface 23 of the breathing
circuit interface 16.
[0043] The exhalation grooves 258 are sufficiently long so that,
when the entrainment valve assembly 200 is pushed as far as it can
go into the breathing circuit interface 16, the grooves 258 still
extend outwardly from the breathing circuit interface 16 and
provide a path for allowing the exhaled gas to exit through the
grooves 258. In addition, for any extent of friction fitting
engagement between the surfaces 23, 25, the cross-sectional area of
the gap or space provided by the grooves 258 will be constant, so
that the expired gas flow path to the exterior of the mask 258
provides constant resistance, irrespective of whether the
entrainment valve assembly 200 is fully inserted or somewhat less
than fully inserted into the breathing circuit interface 16.
[0044] Referring to FIG. 5, the entrainment valve assembly 200
includes a pressure port 260. The pressure port 260 extends from
the bent tubular region 233 of the entrainment valve assembly 200
and is generally parallel to the second connector portion 232 of
the entrainment valve assembly 200. A removable cap 262 is used to
close the pressure port 260. The cap 262 includes gripping tab 264
to aid in removal of the cap 262 from the pressure port 260. A
sampling tube (not shown) may be disposed in fluid communication
with the gas within tubular body 201 through the pressure port 260.
A transducer (not shown) can be secured to the sampling tube, and a
processor communicates with the transducer. The processor
calculates at least one respiratory parameter using the signal from
the transducer. This is generally used to measure pressure by the
ventilator as control feedback to the ventilator.
[0045] As shown in FIGS. 6 and 7, the breathing circuit interface
16 includes the aforementioned first portion 17 and second portion
19. The first portion 17 is generally circular in shape and
includes an annular flat wall 408 that engages a radially inwardly
extending flange portion 70 in slidable surface relationship. The
flange portion 70 surrounds opening 13 in the rigid portion 21 of
the mask body 12 (see FIG. 3). The first portion 17 of the
breathing circuit interface 16 further includes generally
cylindrical protruding portion 409 that extends outwardly from a
radially innermost portion of annular surface 408. The cylindrical
protruding portion 409 extends into the opening 13 in the rigid
portion 21 of the mask body 12. The cylindrical protruding portion
409 has a groove 410 located in the outer cylindrical surface
thereof (see FIG. 7). The groove 410 accommodates a connecting
washer or a bearing 412. The washer 412 in one embodiment is a
split ring washer structure that has an outer periphery thereof
that bears against the inner surface of the flange 70, and its
inner periphery received groove 410 so as to rotatably connect the
breathing circuit interface 16 with the mask body 12. Thus, the
breathing circuit interface 16 is rotatably connected with the
rigid portion 21 of the mask body 12. Slight friction at the
rotatable interface may, in one embodiment, provide at least
resistance to rotation, so that the rotational position of the
breathing circuit interface 16 can be manually set as desired, and
it will retain that position so that the leg or the second
connector portion 232 of the conduit 18 that connects with tubing
can be positioned in a desired direction that is generally retained
unless intentionally altered. In another embodiment, the friction
at the point of rotation can be minimal, to allow free rotation of
the breathing circuit interface 16.
[0046] In another embodiment, the connection between the breathing
circuit interface 16 and the rigid portion 21 of the mask body 12
may be achieved by using a ball bearing arrangement or any other
type bearing arrangement that allows a rotating motion of the
breathing circuit interface 16 with respect to the mask body
12.
[0047] As discussed above, the inner surface 23 of the breathing
circuit interface 16 is shaped and configured to engage detachably
with an outer surface 25 of the entrainment valve assembly 200 by a
friction-fit. In addition to allowing friction fit with the
entrainment valve assembly 200, the inner surface 23 of the
breathing circuit interface 16 allows the entrainment valve
assembly 200 to be removed and interchangeably friction fitted with
different, other types of the conduits 18 through a similar
friction fit, as will be described in more detail later. The
diameter of the first connector portion 230 is larger than the
diameter of the second connector portion 232 of the entrainment
valve assembly 200 to prevent the wrong end of the valve assembly
200 from being connected with interface 16.
[0048] The entrainment valve assembly 200 includes a valve member
208. The valve member 208 is connected to the tubular member 201 at
connection region 248 thereof by means of a recess 250 and a barb
526 and a stop member 528 provided in the valve member 208 (see
FIGS. 8 and 9). A rib 252 (see FIG. 7), located on the lower
portion of the bent tubular region 233 of the entrainment valve
assembly 200, has an outer surface thereof that is received in
recess 250 so as to clamp the connecting region 248 against a
portion 234 of an annular flange 253.
[0049] The valve member 208 has a sealing portion 520, having a
relatively thin, flat, oval configuration. The sealing portion 520
is made of a flexible material and thus capable of bending upwardly
(as shown in the dashed lines in FIG. 7) in response to pressurized
gas being forced into the primary inlet 202. The upward bending
continues until an upper surface 522 of the sealing portion 520
engages an annular lip 235 at the end of a cylindrical wall 254
protruding into the tubular body 201 and defining the secondary
inlet 204. The direction of travel of the sealing portion 520 from
its rest position to the upper bent portion is shown by arrow A in
FIG. 7. In this upper bent portion, the sealing engagement of the
upper surface 522 of the valve member 208 with annular lip 235
causes the secondary inlet 204 to be sealed so that pressurized gas
provided into the primary inlet 202 does not escape through the
secondary inlet 204.
[0050] It should be noted that where gas is not being provided to
the patient through the primary inlet 202 (e.g., the blower
connected with the primary inlet 202 is not operating), the
secondary inlet 204 may serve as both an inlet passage of
atmospheric air provided to the patient during inhalation and an
outlet passage for exhalation. In this instance, the sealing
portion 520 may remain at its at rest position, wherein it forms a
seal with an upper surface 259 of the annular flange 253, as shown
in FIG. 7.
[0051] The valve member 208 can be made from rubber, latex,
silicone, or any other elastomeric material as would be appreciated
by one skilled in the art.
[0052] As can be appreciated most readily from FIG. 4 and FIG. 19
(which is a cross-sectional view taken through A-A in FIG. 6), the
exhalation grooves 258 form a passage between the exterior surface
25 of the tubular portion 201 and the interior cylindrical surface
23 of the breathing circuit interface 16. In one embodiment, the
exhalation grooves 258 are provided on opposite lateral sides of
the exterior surface 25 of the tubular portion 201. In another
embodiment, the exhalation grooves may be provided on the inner
surface 23 of the breathing circuit interface 16 rather than on
body 201. In addition, as shown as dashed lines in FIG. 7, in
another embodiment they may alternatively, or also, be located at
the top portion of the exterior surface 25 of the body 201. When
the user inhales, a very small fraction of gas may be drawn from
atmosphere through the exhalation grooves 258. However, by and
large, the pressurized gas forced into the primary inlet 202 will
create higher pressure within the body 201 than the atmospheric
pressure, so that air is mostly forced outwardly through the
exhalation passages 258 (rather than inwardly), even during
inhalation. Moreover, as the user exhales, the exhaled gas impacts
the centrally incoming airflow through the body 201 and is thus
forced to mushroom radially outwardly resulting in a circular flow
pattern that effectively flushes the exhaled gas, and is thus
generally directed toward and through the peripheral exhalation
grooves 258 to atmosphere.
[0053] As best seen in FIG. 6, the flexible peripheral seal portion
20 may have a generally rectangular channel shaped cross-sectional
configuration with three sides 504, 506 and 508. The flexible
peripheral seal structure 20 may be attached to the mask body 12 at
side 504. An edge 500 of the rigid portion 21 of the mask body 12
engages with an opening 502 located in the side 504 of the flexible
peripheral seal structure 20, such that a layered connection is
formed. The parts are then adhered in place, through an adhesive
connection, an ultrasonic weld connection, a riveted or a pinned
connection or any other type of connection as would be appreciated
by one skilled in the art. Other embodiments are contemplated in
which there is no overlap, such as by attaching the rigid portion
21 and flexible peripheral seal structure 20 with their edges end
to end (e.g., by an adhesive connection). The side 506 is located
between side 504 and side 508, providing a gap between sides 504
and 508. This gap may provide flexibility to the flexible
peripheral seal portion 20, as it conforms to the face of the user
27. The corners of the flexible peripheral seal portion 20 may be
generally rounded. The length of the sides 508 and 506 may vary
along the periphery of the seal structure 20 so as to provide a
conforming sealing engagement of the mask body 12 with the face of
the patient 27.
[0054] FIGS. 10-12 show the replaceable and interchangeable concept
of the conduit 18 with respect to the breathing circuit interface
16. Specifically, in FIGS. 10-12, the entrainment valve assembly
200 is shown being replaced by a standard elbow 300, both of which
can be used as examples for the conduit 18. However, as discussed
later, other elbow configurations may also be friction fitted with
the breathing circuit interface 16.
[0055] FIG. 10 shows the entrainment valve assembly 200 having been
removed from the mask assembly 10. This can be done by simply
pulling the entrainment valve assembly 200 away from the mask
assembly 10 to release friction fit as discussed earlier. FIGS. 11
and 12 show the mask assembly 10 being connected with the standard
elbow 300 by a similar friction fit. The standard elbow 300 has no
internal valve and no exterior exhalation grooves. The standard
elbow 300 provides a tubular, elbow shaped body 301 that is
otherwise similar to tubular body 201 for providing a connection
between the breathing circuit interface 16 and the tubing that will
provide breathing gas to the mask assembly 10. The standard elbow
300 may optionally be provided with the pressure port 260 and
pressure cap 262 as discussed with respect to the entrainment valve
assembly 200. In one embodiment, body 301 is formed from a clear
(transparent), but colored (e.g., blue) plastic material.
[0056] The removable and replaceable conduits 18 enable the mask
assembly 10 to be functional for different uses, simply by
employing the conduit 18 of choice.
[0057] Though FIGS. 10-12 show the mask assembly 10 that is adapted
to accommodate the entrainment valve assembly 200 and standard
elbow 300 interchangeably, listed below are some non-limiting
examples of other types of conduits 18 that can be used
interchangeably with the mask assembly 10 described above: [0058]
Conduit with a bronchoscope port to permit the care giver to
perform a bronchoscopy procedure with mask on [0059] Conduit with
aerosol generator adapter to deliver medication during NIV [0060]
Conduit with MDI port to deliver medication using a "Metered Dose
Inhaler" [0061] Conduit with port to accommodate a CPAP relief
valve [0062] Conduit with C02 sensor capabilities to monitor
patient [0063] Conduit with Volumetric C02 sensor capabilities to
monitor patient VC02 [0064] Conduit that entrains Heliox or other
specialty gases [0065] Conduit that adds moisture to inhaled gas
[0066] Conduit that includes an HME [Heat moisture exchanger]
[0067] Conduit that incorporates "nano" sensors for a variety of
clinical monitoring capabilities [0068] Conduit with Filtered
Exhalation [useful in pandemic situations like SARS] [0069] Conduit
that enhances the patients ability to "Speak with Mask On" [0070]
Conduit that accommodates a NG feeding tube [0071] Conduit that
reduces/control C02 re-breathing [0072] Conduit that aids in
secretion clearance [0073] Conduit with Standard Elbow [0074]
Conduit that can be used on a wide range of mask types [Such as
Full, Nasal or Total or Helmet]
[0075] It should be appreciated, that the above listed conduit
configurations provide non-limiting examples of different types,
configurations and/or constructions of conduits that can be
provided. It should be appreciated that, while these conduits may
all be provided with an elbow shaped tubular body; other tubular
shapes (such as a straight tubular configuration) may alternatively
be provided.
[0076] Other embodiments are contemplated in which the connection
between the conduit 18 and the breathing circuit interface 16 is
not a friction fit, but may be achieved by virtue of other types of
connections such as a quarter-turn type connection, a snap fit, or
any other locking mechanism that provides a detachable connection
between the conduit 18 and the breathing circuit interface 16.
[0077] In yet another embodiment, the first connector portion 230
of the conduit 18 may itself be provided with a swivel coupling,
similar to the breathing circuit interface 16, rather than such
structure being provided as part of the mask. In that case, the
swivel coupling of the elbow can be connected directly to a
non-swiveled portion (e.g., an outwardly projecting cylindrical
configuration) surrounding the opening 13 in the rigid portion 21
of the mask body 12.
[0078] In yet another embodiment, no swivel coupling is provided.
Rather, a direct connection between the tubular body (e.g., 201 or
301) is provided with a correspondingly shaped portion of the rigid
portion 21 of the mask. In this embodiment, some rotation of the
conduits 18 may nevertheless be accommodated via direct sliding
friction at the friction fit connection between rigid portion 21
and the tubular body. However, it is further contemplated that
other, non-rotational connections may also be provided and will
still enable the modularity of design contemplated herein.
[0079] In one aspect of the invention, a mask assembly kit is
provided. The kit assembly includes the mask body 12, with or
without the rotatable interface 16, and at least two conduits 18 of
different types to enable the mask body 12 to provide different
functionality simply by changing conduit types. For example, the
standard elbow 300 (valveless) can be provided as one conduit, and
the entrainment valve assembly 200 can be provided as another
conduit. More than two conduits may be provided, and more than one
mask may be provided, although each of the masks will have a common
configuration, while the conduits will have at least two different
configurations that fit the mask body.
[0080] FIG. 13 shows a rear perspective view of the mask assembly
10. The flexible seal structure 20 can be clearly seen here. Also
shown are the headgear strap retaining tabs 24 and portions of
headgear attachment members 22, which are partially obstructed by
the headgear attachment clips 14. FIGS. 14-16 show the headgear
attachment members 22 more clearly. The headgear attachment members
22 are integrally formed with the rigid portion 21 and extend
outwardly therefrom, beyond the flexible peripheral seal structure
20. Specifically, the headgear attachment members 22 each have a
generally flat web portion 78 integrally connected with the rigid
portion 21 of the mask body 12, and a connecting post or barrel 82
disposed at the outer end of the web portion 78. The web portion 78
gradually tapers from the mask body 12 to the barrel 82. The
headgear attachment members 22 each include a front surface 84 and
a rear surface 86. A reinforcement rib 88, which extends along the
web 78 from the mask body 12 to the barrel 82, is provided on the
rear surface 86 on each of the webs 78. Each barrel or post 82
includes a front face 90 and a rear face 92. The front face 90 of
the barrel 82 is generally semi-cylindrical in shape with a groove
94 located centrally thereof, as best seen in FIG. 14. The front
face 90 has an upper semi-cylindrical surface portion 91 and a
lower semi-cylindrical surface portion 93 on opposite sides of
groove 94. The rear face 92 of the barrel 82 includes a channel 96
located between opposite ends 104 and 106 of the barrel 82. The
channel 96 is divided into four segments by three generally
semi-circular projections 108, 110 and 112 (top projection 108,
middle projection 110, and bottom projection 112). The thickness of
the central circular projection 110 is greater than the thickness
of the circular projections 108 and 112.
[0081] FIGS. 17 and 18 show one of the headgear attachment clips
14. The headgear attachment clips 14 each include a front face 116,
a rear face 118, a top face 120, a bottom face 122, a first side
face 124 and a second side face 126. When the headgear attachment
clip 14 is assembled with the mask body 12, the top face 120 faces
upwards towards the headgear strap retaining tabs 24 of the mask
body 12, the bottom face 122 faces away from the headgear strap
retaining tabs 24 of the mask body 12, the first side face 124
faces the mask body 12, and the second side face 126 faces away
from the mask body 12. Finger indentations 128 having gripping ribs
129 are located on the top face 120 and the bottom face 122 of the
headgear attachment clips 14. The gripping ribs 129 provide a
region for the patient 27 or care giver to grip the headgear
attachment clips 14 while securing or removing the headgear
assembly 11 with the mask body 12. The headgear attachment clips 14
include an elongated opening 130 that receives the straps 40 of the
headgear assembly 11.
[0082] As shown in FIG. 17, the rear face 118 of the headgear
attachment clips 14 includes a cavity 134, which is generally
rectangular in shape and includes three cam fingers 136, 138 and
140 that extend from a wall 133 defining one side of the elongated
opening 130. The cam fingers 136, 138 and 140 extend about half way
through the cavity 134. The thickness of the central cam finger 138
is greater than the thickness of the upper and lower cam fingers
136 and 140 respectively. The cam fingers 136, 138 and 140 are
generally rectangular in shape and connected along one side to wall
133 and on the bottom to a bottom wall 137 of the cavity 134. Each
of the cam fingers 136, 138 and 140 has a chamfered edge located on
the top corners 139 that are located away from the side wall 133.
The edges 145 of the cam fingers 136 and 140 that extend downwardly
from the corners 139 are sloped at a positive angle so that they
extend away from wall 133 as they extend downwardly to join bottom
wall 137. In contrast, the chamfered corner 139 on the central cam
finger 138 terminates at a hard corner 141 that protrudes slightly
beyond the edges 145 of cam fingers 136 and 140, and then extends
at a negative angle to form an undercut, such that its forward edge
149 extends slightly in a direction towards wall 133 as it extends
towards bottom wall 137. The hard corner 141 provides a primary
point of camming contact with the barrel 82 (and in particular,
central projection 110 thereof) to lock and unlock (or connect and
disconnect) the barrel 82 to the headgear attachment clip 14 as
will be described. The cavity 134 includes an elongated channel 135
that does not contain the cam fingers 136, 138 and 140. An outer
wall 148 of the headgear attachment clip 14 defines one end of the
cavity 134, opposite the wall 133. The top portion of wall 148
includes a chamfered top portion 151, and also includes a pair of
overhangs 143. The overhangs 143 serve a similar function to the
hard corner 141, but engage with semi-cylindrical surfaces 91 and
93 respectively (see FIG. 14), as will be described.
[0083] As shown in FIG. 18, the front face 116 of the headgear
attachment clips 14 includes three rectangular openings 142, 144
and 146 that are located in the wall 137. The three rectangular
openings 142, 144 and 146 extend into the channel 135 of the cavity
134 on the rear face 118 (see FIG. 17). The openings 142 and 146
are disposed closely to outer wall 148, while the opening 144 is
offset and disposed at the bottom of sloping surface 149 of cam
finger 138.
[0084] The headgear attachment clips 14 along with the headgear
straps 40 are connected to their respective headgear attachment
members 22 by moving the headgear attachment clips 14 toward the
barrels 82 so that the channel 135 of the headgear attachment clips
14 are forced onto the barrels 82 of the headgear attachment
members 22. Specifically, the cam finger 138 (and specifically, the
hard corner 141) of the headgear attachment clips 14 engages with
the corresponding semi-circular projection 110 of the barrel 82,
and the overhangs 143 of the headgear attachment clips 14 engage
with the surfaces 91 and 93 on the opposite side of the barrel 82.
A camming motion between the cam finger 138 of the headgear
attachment clips 14 and the corresponding circular projection 110
of the barrel 82 of the headgear attachment members 22 causes a
bending of the web portions 78, and a slight flexing of the cam
finger 138 and/or circular projection 110 to allow the circular
projection 110 to move past the hard corner 141 and into the
channel 135. Similarly, the flexing movement of web 78, together
with slight flexing of the overhangs 143 and/or surfaces 91 and 93
enable the surfaces to be cammed passed the overhangs 143. When the
barrel 82 is disposed within channel 135, the overhangs 143 and the
hard corner 141 prevents the barrel 82 from escaping the channel
135. The overhangs 143 of the headgear attachment clips 14 engage
with the surfaces 91 and 93 on the opposite side of the barrel 82,
thus allowing for rotation of the headgear attachment clip 14
during adjustment or to accommodate different head sizes.
[0085] In one embodiment, rather than a camming action the headgear
attachment clips 14 are pulled off or pushed onto the headgear
attachment members 22 by a snapping action over hard corners 141
without camming, and the cam finger 138 of the headgear attachment
clips 14 engages with the corresponding semi-circular projection
110 of the barrel 82.
[0086] To remove headgear attachment clips 14, the user 27 or
caregiver places his fingers on the finger indentations 128 and
pulls the headgear attachment clips 14 in a direction away from the
flexible peripheral seal structure 20 towards the protrusion 60.
The headgear attachment clips 14 rotate about an axis defined by
the barrel 82 until the chamfered top portions 151 of the wall 148
engages the front surface 84 of the web 78. Rotational force
applied to the headgear attachment clips 14 (e.g., manual force) in
a direction forcing surface 151 against surface 84 causes a camming
action that creates a flexing of the aforementioned parts and
surfaces that lock barrel 82 within channel 135, so as to cam the
barrel 82 out of locking engagement within the channel 135. In one
embodiment, the headgear attachment clips 14 may be molded from a
plastic material, but other materials such as rubber, elastomeric
material, or metal are also contemplated.
[0087] In another embodiment of the headgear attachment clips 14 as
shown in FIGS. 20-23, the headgear attachment clips 14 each include
a front face 116, a rear face 118, a top face 120, a bottom face
122, a first side face 124 and a second side face 126. When the
headgear attachment clip 14 is assembled with the mask body 12, the
top face 120 faces upwards towards the headgear strap retaining
tabs 24 of the mask body 12, the bottom face 122 faces away from
the headgear strap retaining tabs 24 of the mask body 12, the first
side face 124 faces the mask body 12, and the second side face 126
faces away from the mask body 12. The headgear attachment clips 14
include an elongated opening 130 that receives the straps 40 of the
headgear assembly 11. In addition, this embodiment includes an
auxiliary elongated opening 152. The elongated opening 152 is
defined by an inner auxiliary wall 154, an outer auxiliary wall
156, and side auxiliary walls 158. The inner auxiliary wall extends
from bottom face 122.
[0088] As shown in FIG. 23, the rear face 118 of the headgear
attachment clips 14 includes a cavity 134, which is generally
rectangular in shape and includes three cam fingers 136, 138 and
140 that extend from a wall 133 defining one side of the elongated
opening 130. The cam fingers 136, 138 and 140 extend about half way
through the cavity 134. The thickness of the central cam finger 138
is greater than the thickness of the upper and lower cam fingers
136 and 140 respectively. The cam fingers 136, 138 and 140 are
generally rectangular in shape and connected along one side to wall
133 and on the bottom to a bottom wall 137 of the cavity 134. Each
of the cam fingers 136, 138 and 140 has a chamfered edge located on
the top corners 139 that are located away from the side wall 133.
The edges 145 of the cam fingers 136 and 140 that extend downwardly
from the corners 139 are sloped at a positive angle so that they
extend away from wall 133 as they extend downwardly to join bottom
wall 137. In contrast, the chamfered corner 139 on the central cam
finger 138 terminates at a hard corner 141 that protrudes slightly
beyond the edges 145 of cam fingers 136 and 140 to form an
undercut, and then extends at a negative angle, such that its
forward edge 149 extends slightly in a direction towards wall 133
as it extends towards bottom wall 137. The hard corner 141 provides
a primary point of camming contact with the barrel 82 (and in
particular, central projection 110 thereof) to lock and unlock (or
connect and disconnect) the barrel 82 to the headgear attachment
clip 14 as will be described. The cavity 134 includes an elongated
channel 135 that does not contain the cam fingers 136, 138 and 140.
An outer wall 148 of the headgear attachment clip 14 defines one
end of the cavity 134, opposite the wall 133. The top portion of
wall 148 includes a chamfered top portion 151, and also includes a
pair of overhangs 143. The overhangs 143 serve a similar function
to the hard corner 141, but engage with semi-cylindrical surfaces
91 and 93 respectively (see FIG. 14), as will be described.
[0089] As shown in FIG. 22, the front face 116 of the headgear
attachment clips 14 includes three rectangular openings 142, 144
and 146 that are located in the wall 137. The three rectangular
openings 142, 144 and 146 extend into the channel 135 of the cavity
134 on the rear face 118 (see FIG. 23). The openings 142 and 146
are disposed closely to outer wall 148, while the opening 144 is
offset and disposed at the bottom of sloping surface 149 of cam
finger 138.
[0090] The headgear attachment clips 14 along with the headgear
straps 40 are connected to their respective headgear attachment
members 22 by moving the headgear attachment clips 14 toward the
barrels 82 so that the channel 135 of the headgear attachment clips
14 are forced onto the barrels 82 of the headgear attachment
members 22. Specifically, the cam finger 138 (and specifically, the
hard corner 141) of the headgear attachment clips 14 engages with
the corresponding semi-circular projection 110 of the barrel 82,
and the overhangs 143 of the headgear attachment clips 14 engage
with the surfaces 91 and 93 on the opposite side of the barrel 82.
A camming motion between the cam finger 138 of the headgear
attachment clips 14 and the corresponding circular projection 110
of the barrel 82 of the headgear attachment members 22 causes a
bending of the web portions 78, and a slight flexing of the cam
finger 138 and/or circular projection 110 to allow the circular
projection 110 to move past the hard corner 141 and into the
channel 135. Similarly, the flexing movement of web 78, together
with slight flexing of the overhangs 143 and/or surfaces 91 and 93
enable the surfaces to be cammed passed the overhangs 143. When the
barrel 82 is disposed within channel 135, the overhangs 143 and the
hard corner 141 prevents the barrel 82 from escaping the channel
135. The overhangs 143 of the headgear attachment clips 14 engage
with the surfaces 91 and 93 on the opposite side of the barrel 82,
thus allowing for rotation of the headgear attachment clip 14
during adjustment or to accommodate different head sizes.
[0091] In this embodiment, the mask assembly may be provided with
an additional strap, not shown, connected between the auxiliary
openings 152 and below the chin. This construction provides
additional under-the-chin support for the mask 12 to hold it in
place rather than permitting it to ride up the patient's face.
[0092] The flexible peripheral seal structure 20 of the mask body
12 may be made of a relatively soft and/or flexible material so
that the flexible peripheral seal structure 20 conforms to the
shape of a patient's face when held against it. The flexible
peripheral seal structure 20 may be made of, for example, silicone,
an elastomeric material or any other suitable shape conforming
material as will be appreciated by one skilled in the art.
Different regions of the flexible peripheral seal structure 20
around the perimeter of the mask body 12 may have different
cross-sectional configurations. Various other flexible peripheral
seal structure 20 configurations will become apparent to those
skilled in the art. The flexible peripheral seal structure 20 is
generally annular to form a seal around the nose and the mouth and
may be generally oblong shaped, pear shaped (as shown in FIG. 13)
or any other suitable shape as will be appreciated by one skilled
in the art. The rigid portion 21 of the mask body 12, in one
embodiment, is made of a relatively more rigid material than the
flexible peripheral seal structure 20. For example, mask body 12
may be made from polycarbonate, or other suitable material.
[0093] The mask body 12 may be formed by a two-step insert molding
process. For example, the rigid portion 21 may be molded first and
then inserted into a second mold for the flexible peripheral
flexible peripheral seal structure 20, which is injection molded to
form around and/or into the rigid portion 21.
[0094] In one embodiment, the headgear assembly 11 that is used to
mount the mask body 12 to the head of a patient 27 takes the form
of straps. However, any structure that secures the mask body 12 to
the head of a patient can be used. In the illustrated embodiment as
shown in FIGS. 1A and 1B, an end potion 41 of each of the two
headgear straps 40 (only one shown in FIG. 1B) is threaded through
the elongated opening 50 of the headgear retaining tab 24, and the
end portion 41 of the lower headgear straps 40 are threaded through
the elongated opening 130 of the headgear attachment clip 14. In
one embodiment, the end portion 41 comprise hook material and is
bent back into engagement with the adjoining surface 401, formed of
loop material, on the straps 40 so as to form a hook and loop (or
VELCRO) type connection. It is to be appreciated, however, that
there are numerous other ways for securing the end portion of the
headgear strap to itself or to the headgear attachment clip 14
and/or to the headgear attachment tab 24, such as a snap
connection, buckle, or locking clamp, as non-limiting examples. The
headgear 11 is adjustable, as the straps 40 can be pulled further
through the opening 50 of the headgear retaining tab 24 or the
elongated opening 130 of the headgear attachment clip 14 to
accommodate smaller diameter head sizes.
[0095] In addition, in another embodiment, a more permanent
attachment of the end portion of the headgear strap 40 to the
headgear strap retaining tabs 24 or the headgear attachment clips
14 may be provided. For example, once the patient/user 27 sets the
headgear strap 40 to the desired length and threaded in through the
elongated opening 50 of the headgear strap retaining tabs 24 or the
elongated opening 130 of the headgear attachment clips 14, the free
end of the strap 40 can be permanently fixed back onto the strap
40, such as by gluing, sewing, or riveting the overlapping straps
together. The straps 40 of the headgear assembly 11 may be elastic
or inelastic, and may extend around the back of the head of the
patient 27 to secure the mask body 12 on the patient 27, with the
flexible peripheral seal structure 20 in sealing engagement with
the patient's face.
[0096] The mask, as shown in FIG. 1, is a total face mask that
accommodates substantially the entire facial area (including the
nose, the mouth and the eyes) of the patient. It is to be
understood, however, that the present invention also contemplates
an oral/nasal mask that accommodates only the mouth and the nose of
a user. The configuration of the mask may vary and is not limited
to a particular size or configuration, as patients may range in
age, size, and/or medical purpose so as to require appropriate
selection from among a variety of different mask sizes and
configurations as would be appreciated by one skilled in the art.
In one embodiment, the size of the face mask is embossed on the
lower end portion of the flexible peripheral seal structure 20 as
shown by 600 in FIG. 13.
[0097] Although the invention has been described in detail for the
purpose of illustration based on what is currently considered to be
the most practical and preferred embodiments, it is to be
understood that such detail is solely for that purpose and that the
invention is not limited to the disclosed embodiments, but, on the
contrary, is intended to cover modifications and equivalent
arrangements that are within the spirit and scope of the appended
claims. For example, it is to be understood that the present
invention contemplates that, to the extent possible, one or more
features of any embodiment can be combined with one or more
features of any other embodiment.
* * * * *