Note: Descriptions are shown in the official language in which they were submitted.
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ANESTHESIA GAS DELIVERY AND MONITORING SYSTEM
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims benefit of U.S. Application No. 16/378,141, filed
April 8, 2019,
which is incorporated herein by reference in its entirety.
BACKGROUND
Approximately 200,000,000 sedation procedures are performed in the U.S every
year.
Patient monitoring during sedation procedures can require the use of a nasal
cannula with the
prongs inserted into the nostrils to deliver oxygen while monitoring exhaled
carbon dioxide. A
wide range of issues from inaccurate monitoring to patient injury make this
setup unreliable with
significant room for improvement.
Nasal insertion of the prongs in patients with oral breathing often leads to a
cascade of
monitoring issues. Moving the nasal prongs into the patient's mouth is
unhygienic but performed
regularly in the absence of a better option. Nasal cannulas are insecure and
often get dislodged
causing loss of carbon dioxide capture as well as inability to deliver oxygen
into the nostrils.
During facial procedures, nasal cannulas get in the sterile surgical field
causing a risk for
surgical infections.
Oxygen is heavier than air and tends to settle around the face. Every year
several hundred
cases of surgical fires causing patient injury are reported when an
electrocautery is used.
Electrocautery causes sparks and oxygen acts as fuel.
Approximately two million patients in the U.S are on oxygen therapy either at
home or in
the nursing homes. Oxygen is delivered through a nasal cannula which is
connected to a portable
oxygen tank. These patients encounter multiple issues. Nasal cannula tubing
has a large surface
area that comes in contact with facial skin and long-term use can cause skin
irritation, dermatitis
or skin ulcers. Continuous oxygen flow through the nostrils can cause mucosal
dryness. As
prevention, humidifier bottles are added but water vapor condensation not only
blocks the
oxygen flow to the patient, it can also promote bacterial growth in the
tubing. Part of the oxygen
delivery through the nasal prongs gets wasted during breath exhalation. A
typical oxygen tank
lasts 4-5 days. It is estimated that 40-60% of the patients on home oxygen
therapy continue to
smoke. Lighter flame in close proximity to the plastic prongs emitting oxygen
causes serious
injuries, death and loss of property each year in the U.S. Therefore, the
current nasal cannula
lacks appropriate safety and reliability.
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SUMMARY
Disclosed herein is a gas delivery and monitoring apparatus that can be used,
for
example, to deliver oxygen and monitor exhaled carbon dioxide in a subject
while under
anesthesia. One advantage of the disclosed apparatus is the ability to deliver
oxygen directly to
the back of the mouth instead of in front of the face. Another advantage of
the disclosed
apparatus over existing nasal cannulas is the ability to capture carbon
dioxide exhaled from both
the nose and mouth.
The disclosed apparatus comprises a support member having a channel
therewithin
extending along a longitudinal axis from a proximal end of the channel to a
distal end of the
channel, and a bite block affixed to the support member sized to be inserted
within a mouth of a
subject.
The disclosed apparatus also comprises a first elongated conduit defining an
exhalation
capture flow path extending from an exhalation capture manifold, through the
channel from the
distal end to the proximal end, and terminating in an outlet port. In
particular embodiments, the
exhalation capture manifold captures air exhaled from a subject, which travels
through the first
elongated conduit to the outlet port, where it is connected to a carbon
dioxide monitoring system
(capnograph). The exhalation capture manifold preferably contains a first
capture inlet and a
second capture inlet each fluidly connected to the exhalation capture
manifold. This allows for
one inlet to be positioned for capture of exhalation from the nose, while
another inlet is
positioned for exhalation by the mouth. Therefore, in particular embodiments,
the first capture
inlet and a second capture inlet have perpendicular flow paths.
The disclosed apparatus also comprises a second elongated conduit defining a
gas
delivery flow path extending from an inlet port, through the channel from the
proximal end to
the distal end, into the bite block, and terminating in a gas delivery port.
In particular
embodiments, the inlet port is connected to an oxygen source, which delivers
oxygen through the
second elongated conduit to the gas delivery port. Therefore, in some
embodiments of the
apparatus, the inlet port is fluidly-connectable to a source of pressurized
oxygen.
Oxygen exits the delivery port for inhalation by the subject. The delivery
port is
positioned by the bite block within the mouth instead of in front of the face.
In some cases, the
second elongated conduit extends through and past the bite block to terminate
in the gas delivery
port (i.e., the gas delivery port extends past the bite block). In other
embodiments, the bite block
further comprises an outlet manifold fluidly connected to the gas delivery
port.
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The remaining dimensions of the first elongated conduit and second elongated
conduit
relative to the support member and bite block can be selected based on
anatomical needs. For
example, in some embodiments, the distance between the distal end of the
channel and the
exhalation capture manifold is about 4 to 8 cm.
Various other embodiments include a gas delivery and monitoring apparatus
having a
support member, a bite block, a first elongated conduit, a second elongated
conduit, and a
bridge. The support member has a longitudinal axis. The bite block is affixed
to the support
member and is sized to be inserted within a mouth of a subject. The first
elongated conduit
defines an exhalation capture flow path extending from a capture inlet at the
distal end of the bite
block and terminating in an outlet port. The second elongated conduit defines
a gas delivery
flow path extending from an inlet port into the bite block and terminating in
a gas delivery port
at the distal end of the bite block. Both the gas delivery port and capture
inlet are located in the
mouth of the subject when the bite block is inserted in the mouth of the
subject during use. The
bridge connects the bite block to the support member. The bridge extends away
from the
support member. The bridge positions the bite block a first minimum distance
from the support
member such that the support member and the bite block are simultaneously
positionable on
opposite sides of a cheek of a subject.
In some embodiments, the support member has a channel therewithin extending
along the
longitudinal axis from a proximal end of the channel to a distal end of the
channel.
In some embodiments, the apparatus further includes a third elongated conduit
defining a
nasal exhalation capture flow path extending from a secondary capture inlet,
through the channel
from the distal end to the proximal end, and terminating in an outlet port.
In some embodiments, the first elongated extends through the channel from the
proximal
end to the distal end. In some embodiments, the second elongated conduit
extends through the
channel from the proximal end to the distal end.
In some embodiments, the bridge extends away from the support member along a
transverse plane perpendicular to the longitudinal axis. The bridge positions
the bite block a first
minimum distance from the support member. In some embodiments, the first
minimum distance
is 1 to 3 cm. In some embodiments, the bridge is deformable to a second
minimum distance
from the support element. In some embodiments, the second minimum distance is
1 to 3 cm. In
some embodiments, the bridge provides spring tension to secure the bite block
within the mouth
of the subject.
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In some embodiments, the second elongated conduit extends through the bite
block to
terminate in the gas delivery port.
In some embodiments, the first elongated conduit includes a flexible
elastomeric material
that is not gas-permeable.
In some embodiments, the third elongated conduit is encased in a deformable
sheath.
In some embodiments, the second elongated conduit comprises a flexible
elastomeric
material that is not gas-permeable.
In some embodiments, the inlet port is fluidly-connectable to a source of
pressurized
oxygen.
In some embodiments, at least a portion of each of the support member, bite
block, and
bridge are integrally formed. In some embodiments, the support member, bite
block, and bridge
are mechanically connected.
In some embodiments, a distance between the distal end of the channel and the
secondary
capture inlet is about 4 to 8 cm.
In some embodiments, the first elongated conduit has an inner diameter of
about 2 to 4
mm. In some embodiments, the second elongated conduit has an inner diameter of
about 2 to 8
mm. In some embodiments, the third elongated conduit has an inner diameter of
about 2 to 4
mm.
In some embodiments, the third elongated conduit comprises a flexible
elastomeric
material that is not gas-permeable.
The details of one or more embodiments of the invention are set forth in the
accompa-
nying drawings and the description below. Other features, objects, and
advantages of the
invention will be apparent from the description and drawings, and from the
claims.
DESCRIPTION OF DRAWINGS
FIG. 1 is a perspective view of a gas delivery and monitoring apparatus
according to one
implementation.
FIG. 2 is a cutout view of a gas delivery and monitoring apparatus according
to one
implementation.
FIG. 3 is an illustration of a gas delivery and monitoring apparatus according
to one
implementation positioned in the mouth of a subject.
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FIG. 4 is an illustration of a gas delivery and monitoring apparatus according
to one
implementation using a "basket" shaped area that can efficiently capture
exhaled oral or nasal
CO2.
FIG. 5 is an illustration of a gas delivery and monitoring apparatus according
to one
implementation using a curved "basket" shaped area that can efficiently
capture exhaled oral or
nasal CO2.
FIG. 6 is a perspective view of a gas delivery and monitoring apparatus,
according to
another implementation.
FIG. 7 is a perspective view of a gas delivery and monitoring apparatus of
FIG. 6
disposed in the mouth of a subject.
FIG. 8 is a perspective view of a gas delivery and monitoring apparatus,
according to
another implementation.
FIG. 9 is a perspective view of a gas delivery and monitoring apparatus of
FIG. 8
disposed in the mouth of a subject.
FIG. 10 is a perspective view of a gas delivery and monitoring apparatus,
according to
another implementation
DETAILED DESCRIPTION
The present invention now will be described more fully hereinafter with
reference to
specific embodiments of the invention. The invention can be embodied in many
different forms
and should not be construed as limited to the embodiments set forth herein;
rather, these
embodiments are provided so that this disclosure will satisfy applicable legal
requirements.
As used in the specification, and in the appended claims, the singular forms
"a," "an,"
"the," include plural referents unless the context clearly dictates otherwise.
The term "comprising" and variations thereof as used herein are used
synonymously with
the term "including" and variations thereof and are open, non-limiting terms.
The term "subject" refers to any individual who is the target of
administration or
treatment. The subject can be a vertebrate, for example, a mammal. Thus, the
subject can be a
human or veterinary patient. The term "patient" refers to a subject under the
treatment of a
clinician, e.g., physician.
Now referring more particularly to Figures 1 and 2 of the drawings, a gas
delivery and
monitoring apparatus 10 is provided that can be used, for example, to deliver
oxygen and
monitor exhaled carbon dioxide in a subject while under anesthesia. As shown
in Figures 1 and
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2, the disclosed gas delivery and monitoring apparatus 10 has a first
elongated conduit 20 for
capturing exhalation from a subject and a second elongated conduit 30 for
delivering gas to the
subject for inhalation.
The first elongated conduit 20 defines an exhalation capture flow path
extending from an
exhalation capture manifold 40 to an outlet port 24. In particular
embodiments, the exhalation
capture manifold 40 captures air exhaled from a subject, which travels through
the first
elongated conduit to the outlet port 24, where it is connected to a carbon
dioxide monitoring
system (capnograph). The exhalation capture manifold 40 preferably contains a
first capture inlet
41 and a second capture inlet 42 each fluidly connected to the exhalation
capture manifold 40.
This allows for one inlet to be positioned for capture of exhalation from the
nose, while another
inlet is positioned for exhalation by the mouth. Therefore, in particular
embodiments, the first
capture inlet 41 and a second capture inlet 42 have perpendicular flow paths.
As shown in
Figures 1 and 2, the first elongated conduit 20 can be inside a deformable
sheath 25, allowing the
exhalation capture manifold 40 to be positioned in front of the subject's nose
and mouth.
The second elongated conduit 30 defines a gas delivery flow path extending
from an inlet
port 32 to a gas delivery port 34. In particular embodiments, the inlet port
32 is connected to an
oxygen source, which delivers oxygen through the second elongated conduit 30
to the gas
delivery port 34. Therefore, in some embodiments of the apparatus, the inlet
port 32 is fluidly-
connectable to a source of pressurized oxygen.
As shown in Figures 1 and 2, the disclosed gas delivery and monitoring
apparatus 10 has
a support member 50 having a channel 52 therewithin extending along a
longitudinal axis 55
from a proximal end of the channel 58 to a distal end of the channel 56. The
support member 50
is affixed to a bite block 70 that is sized to be inserted within a mouth of a
subject.
As shown in Figure 2, the first elongated conduit 20 extends from the
exhalation capture
manifold 40 through the channel 52 from the distal end 56 to the proximal end
58, and
terminating in the outlet port 24.
The second elongated conduit 30 extends from the inlet port 32, through the
channel 52
from the proximal end 58 to the distal end 56, into the bite block 70, and
terminating in the gas
delivery port 34. As depicted in Figure 2, the second elongated conduit 30 can
extend through a
receiving element 72 (such as a channel) in the bite block. In some cases, the
gas delivery port
34 extends past the bite block 70. In other embodiments, the bite block 70
further comprises an
outlet manifold fluidly connected to the gas delivery port 34.
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The support member 50 and bite block 70 are preferably configured so that they
are
positioned on opposite sides of a subject's cheek. As depicted in Figures 1
and 2, a bridge 60 can
connect the bite block 70 to the support member 50. For example, the bridge 60
can extend away
from the support member 50 along a transverse plane perpendicular to the
longitudinal axis 55,
wherein the bridge positions the bite block a first minimum distance from the
support element.
This distance is based on the thickness of a subject's cheek. Therefore, in
some embodiments,
this first minimum distance is about 1 to 3 cm, including about 1.0, 1.5, 2.0,
2.5, or 3.0 cm. The
bridge is also preferably deformable to a second minimum distance from the
support element to
adjust for the size and shape of the subject's mouth and cheek. In these
embodiments, the
deformable distance (in a direction away from the support member) can be about
0.1 to 2 cm. In
some embodiments, deformation of the bridge 60 also provides spring tension to
secure the bite
block 70 within the mouth of the subject. In some embodiments, at least a
portion of each of the
support member, bite block, and bridge are integrally formed. In some
embodiments, the support
member, bite block, and/or bridge are mechanically connected.
The bite block 70 can be a modular embodiment with adjustable heights to
accommodate
various size mouth openings. The bite block 70 can also have openings/ports to
sample oral CO2.
Each of the first elongated conduit 20 and second elongated conduit 30 can be
made from
a flexible elastomeric material that is not gas-permeable. Either of these
conduits can also be
coated or sheathed with another material to provide additional properties,
such as rigidity and
deformability. In particular embodiments, the first elongated conduit is
encased in a deformable
sheath 25 that can be articulated. In some embodiments, the sheath 25 is a
plastic tube with a co-
extruded metal wire that allows the tube to be bent and hold its shape.
Each of the support member 50, bridge 60, and bite block 70 can be made, in
whole or in
part, from a rigid material, such as a metal or plastic.
The inner diameters of the first and second elongated conduits can be selected
based on
desired air pressures. For example, in some embodiments, the first elongated
conduit has an
inner diameter of about 2 to 4 mm. In some embodiments, the second elongated
conduit has an
inner diameter of about 2 to 8 mm.
The outlet port and inlet port can each independently be any length past the
proximal end
of the channel, i.e., for connection to a carbon dioxide monitor and oxygen
source, respectively.
In some cases, the outlet port and/or inlet port are connected to a fitting,
such as a luer tube
fitting (e.g. male or female). In these cases, the apparatus can be connected
to carbon dioxide
monitor and oxygen source by extension tubing.
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Optionally, the gas delivery and monitoring apparatus 10 can be sterilized,
for example
by chemical and/or heat based techniques.
As shown in Figure 4, in some embodiments, the gas delivery and monitoring
apparatus
uses a "basket" shaped area that can efficiently capture exhaled oral or nasal
CO2. In some
embodiments, the exhalation capture manifold comprises a basket shaped area
for the capture of
exhaled oral and/or nasal CO2 though a single capture inlet.
As shown in Figure 5, in other embodiments, the gas delivery and monitoring
apparatus
uses a curved "basket" shaped area that can efficiently capture exhaled oral
or nasal CO2. In
some embodiments, the exhalation capture manifold comprises a curved basket
shaped area for
the capture of exhaled oral and/or nasal CO2 though a single capture inlet. In
some embodiments,
the single capture inlet is fluidly connected to the exhalation capture
manifold. As shown in
Figures 4 and 5, the first elongated conduit can be connected to the single
capture inlet. In some
embodiments, the first elongated conduit is located inside a deformable
sheath, allowing the
exhalation capture manifold to be positioned in front of the subject's nose
and mouth.
Sizeable bite blocks can be added to various embodiments described herein to
facilitate
the placement of an oral-airway, a laryngeal mask airway, or any other life-
saving airway
apparatus in case of an emergency. Another application of the bite block is to
facilitate the
passage of an endoscope in the esophagus or trachea of a patient.
In some embodiments, disclosed herein is a method for the delivery of a first
gas and
monitoring of a second gas, comprising: providing to a subject an apparatus
comprising: a
support member having a channel therewithin extending along a longitudinal
axis from a
proximal end of the channel to a distal end of the channel; a bite block
affixed to the support
member sized to be inserted within a mouth of a subject; a first elongated
conduit defining an
exhalation capture flow path extending from an exhalation capture manifold,
through the channel
from the distal end to the proximal end, and terminating in an outlet port; a
second elongated
conduit defining a gas delivery flow path extending from an inlet port,
through the channel from
the proximal end to the distal end, into the bite block, and terminating in a
gas delivery port; and
wherein the exhalation capture manifold captures exhaled oral and/or nasal
carbon dioxide. In
some embodiments, the first gas comprises oxygen. In some embodiments, the
second gas
comprises carbon dioxide. In some embodiments, the subject is under
anesthesia.
FIGS. 6 and 7 show another embodiment of a gas delivery and monitoring
apparatus 610
similar to the gas delivery and monitoring apparatus 10 shown in FIGS. 1-5,
but in this
embodiment, the first elongated conduit 620 extends through the bite block 670
such that the
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capture inlet 641 of the first elongated conduit 620 is disposed in the mouth
of a subject when
the gas delivery and monitoring apparatus 610 is in use. The gas delivery and
monitoring
apparatus 610 includes a support member 650, a bite block 670, a first
elongated conduit 620, a
second elongated conduit 630, and a bridge 660. The description of features in
the embodiment
shown in FIGS. 1-5 can apply to similar features of the embodiment shown in
FIGS. 6 and 7.
The support member 650 has a channel 652 therewithin extending along a
longitudinal
axis 655 from a proximal end 658 of the channel 652 to a distal end 656 of the
channel 652. The
bridge 660 connects the bite block 670 to the support member 650. The bridge
660 extends
away from the support member 650 along a transverse plane perpendicular to the
longitudinal
axis 655 of the support member 650. The bridge 660 is structured to curve
around the corner of
the mouth of a subject, and the bite block 670 is sized to be inserted within
a mouth of the
subject. The support member 650, bite block 670, and bridge 660 shown in FIGS.
6 and 7 are
mechanically connected to each other. However, in other embodiments, at least
a portion of each
of the support member 650, bite block 670, and bridge 660 are integrally
formed.
The bridge 660 positions the bite block 670 a first minimum distance from the
support
member 650 such that the support member 650 and the bite block 670 are
simultaneously
positionable on opposite sides of the cheek of the subject. The first minimum
distance is based
on the thickness of a subject's cheek. Therefore, in some embodiments, this
first minimum
distance is about 1 to 3 cm, including about 1.0, 1.5, 2.0, 2.5, or 3.0 cm.
The bridge 660 is also
preferably deformable to a second minimum distance from the support member 650
to adjust for
the size and shape of the subject's mouth and cheek. In these embodiments, the
deformable
distance (in a direction away from the support member) can be about 0.1 to 2
cm. In some
embodiments, deformation of the bridge 660 also provides spring tension to
secure the bite block
670 within the mouth of the subject.
The first elongated conduit 620 defines an exhalation capture flow path. The
second
elongated conduit 630 defines a gas delivery flow path terminating in an inlet
port 632 that is
fluidly-connectable to a source of pressurized oxygen. Both the first
elongated conduit 620 and
the second elongated conduit 630 extend through the channel 652 of the support
member 650
similar to the embodiment shown in FIG. 1. However, in the embodiment shown in
FIGS. 6 and
7, both the first elongated conduit 620 and the second elongated conduit 630
extend through the
bite block 670 such that the capture inlet 641 of the first elongated conduit
620 and the gas
delivery port 634 of the second elongated conduit 630 terminate in the mouth
of the subject
when the gas delivery and monitoring apparatus 610 is in use. To facilitate
the first elongated
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conduit 620 extending through the bite block 670, the bridge 660 is sized such
that both the first
elongated conduit 620 and the second elongated conduit 630 are extendable
along the surface of
the bridge 660 to prevent the conduits 620, 630 from kinking when bending
around the corner of
the mouth of the subject.
Each of the first elongated conduit 620 and second elongated conduit 630 can
be made
from a flexible elastomeric material that is not gas-permeable. Either of
these conduits 620, 630
can also be coated or sheathed with another material to provide additional
properties, such as
rigidity and deformability. In particular embodiments, the first elongated
conduit 620 is encased
in a deformable sheath 625 that can be articulated. In some embodiments, the
sheath 625 is a
plastic tube with a co-extruded metal wire that allows the tube to be bent and
hold its shape.
The inner diameters of the first elongated conduit 620 and second elongated
conduit 630
can be selected based on desired air pressures. For example, in some
embodiments, the first
elongated conduit 620 has an inner diameter of about 2 to 4 mm. In some
embodiments, the
second elongated conduit 630 has an inner diameter of about 2 to 8 mm.
Although FIGS. 6 and 7 show the support member 650 having a channel 652
therewithin,
in some embodiments, the support member 650 does not have a channel 652, and
the first
elongated conduit 620 and the second elongated conduit 630 do not extend
through the support
member 650.
FIGS. 8 and 9 shows another embodiment of a gas delivery and monitoring
apparatus
810 similar to the embodiment shown in FIGS. 6 and 7, but in this embodiment,
the device does
not include a support member or a bridge. Rather, a portion of the first
elongated conduit 820
and a portion of the second elongated conduit 830 are rigid and are structured
in a U-shape,
similar to the shape in which the flexible conduits 620, 630 of the embodiment
shown in FIGS. 6
and 7 are held by the support member 650 and the bridge 660. The rigid
portions of the first
elongated conduit 820 and the second elongated conduit 830 positions the bite
block 870 a first
minimum distance from the first elongated conduit 820 and the second elongated
conduit 830
such that the conduits 820, 830 and the bite block 870 are simultaneously
positionable on
opposite sides of the cheek of the subject.
FIG. 10 shows another embodiment of a gas delivery and monitoring apparatus
1010
having a first elongated conduit 1020 and a second elongated conduit 1030
similar to the
embodiment shown in FIGS. 6 and 7, but in this embodiment, the device includes
a third
elongated conduit 1080 for monitoring nasal exhalation. The description of
features in the
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embodiment shown in FIGS. 1-8 can apply to similar features of the embodiment
shown in FIG.
10.
The third elongated conduit 1080 is similar to the first elongated conduit 20
of the
embodiment shown in FIGS. 1-5. The third elongated conduit 1080 defines a
nasal exhalation
capture flow path extending from a secondary capture inlet 1092, through the
channel 1052 of
the support member 1050 from the distal end 1056 to the proximal end 1058, and
terminating in
a secondary outlet port 1084. The third elongated conduit 1080 extends from
the distal end 1056
of the channel 1052 such that a distance between the distal end 1056 of the
channel 1052 and the
secondary capture inlet 1092 is about 4 to 8 cm.
The third elongated conduit 1080 is made from a flexible elastomeric material
that is not
gas-permeable and is encased in a deformable sheath. The third elongated
conduit 1080 has an
inner diameter of 2 to 4 mm, which can be selected based on desired air
pressures.
A number of embodiments of the invention have been described. Nevertheless, it
will be
understood that various modifications may be made without departing from the
spirit and scope
of the invention.
Disclosed are materials, systems, devices, compositions, and components that
can be
used for, can be used in conjunction with, can be used in preparation for, or
are products of the
disclosed methods, systems and devices. These and other components are
disclosed herein, and
it is understood that when combinations, subsets, interactions, groups, etc.
of these components
are disclosed that while specific reference of each various individual and
collective combinations
and permutations of these components may not be explicitly disclosed, each is
specifically
contemplated and described herein.
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