U.S. patent application number 15/272074 was filed with the patent office on 2017-01-12 for ventilation mask.
The applicant listed for this patent is Revolutionary Medical Devices, Inc.. Invention is credited to Steven H. Cataldo, David M. Kane, Michael J. Pedro, Ryan Redford, Thomas Reilly.
Application Number | 20170007795 15/272074 |
Document ID | / |
Family ID | 57504590 |
Filed Date | 2017-01-12 |
United States Patent
Application |
20170007795 |
Kind Code |
A1 |
Pedro; Michael J. ; et
al. |
January 12, 2017 |
VENTILATION MASK
Abstract
A nasal ventilation mask having one or more attachment ports
located adjacent to and overlying an upper lip of a patient when
worn.
Inventors: |
Pedro; Michael J.;
(Brooklyn, NY) ; Cataldo; Steven H.; (New York,
NY) ; Kane; David M.; (Tucson, AZ) ; Reilly;
Thomas; (Tucson, AZ) ; Redford; Ryan; (Tucson,
AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Revolutionary Medical Devices, Inc. |
Tucson |
AZ |
US |
|
|
Family ID: |
57504590 |
Appl. No.: |
15/272074 |
Filed: |
September 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15127759 |
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PCT/US16/37070 |
Jun 10, 2016 |
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15272074 |
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62174410 |
Jun 11, 2015 |
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62204899 |
Aug 13, 2015 |
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62245810 |
Oct 23, 2015 |
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62245794 |
Oct 23, 2015 |
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62253528 |
Nov 10, 2015 |
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62253520 |
Nov 10, 2015 |
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62253512 |
Nov 10, 2015 |
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62255120 |
Nov 13, 2015 |
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62286165 |
Jan 22, 2016 |
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62298265 |
Feb 22, 2016 |
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62298295 |
Feb 22, 2016 |
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62301359 |
Feb 29, 2016 |
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62308127 |
Mar 14, 2016 |
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62319686 |
Apr 7, 2016 |
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62324197 |
Apr 18, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/3368 20130101;
A61M 2210/0625 20130101; A61M 2230/432 20130101; A61M 2210/0618
20130101; A61M 2205/3331 20130101; A61M 2016/0033 20130101; A61B
1/00154 20130101; A61M 16/0683 20130101; A61M 16/0672 20140204;
A61M 2016/1035 20130101; A61M 2202/0208 20130101; A61M 16/0605
20140204; A61M 2016/003 20130101; A61M 2016/103 20130101; A61M
16/01 20130101; A61M 2230/437 20130101; A61M 16/20 20130101; A61M
2210/0625 20130101; A61M 16/0666 20130101; A61M 16/209 20140204;
A61M 16/161 20140204; A61M 16/22 20130101; A61M 2016/0027 20130101;
A61B 1/267 20130101; A61M 2210/005 20130101; A61M 16/0616 20140204;
A61B 5/097 20130101; A61M 16/0488 20130101; A61M 2016/1025
20130101; A61M 16/06 20130101; A61M 16/009 20130101; A61M 2230/435
20130101; A61B 5/082 20130101; A61M 2205/7518 20130101; A61M 16/085
20140204; A61M 16/208 20130101 |
International
Class: |
A61M 16/08 20060101
A61M016/08; A61M 16/20 20060101 A61M016/20; A61M 16/01 20060101
A61M016/01; A61B 5/097 20060101 A61B005/097; A61M 16/22 20060101
A61M016/22; A61M 16/06 20060101 A61M016/06; A61B 5/08 20060101
A61B005/08 |
Claims
1. A nasal mask having one or more attachment ports for supporting
a functional accessory, sealable by at least one self-closing
valve, a septum, a frangible membrane, a plug or a cap, adapted to
be located adjacent to and overlying a region of an upper lip of a
patient when worn.
2. The mask of claim 1, wherein the at least one self-closing valve
comprises a duck valve.
3. The mask of claim 1, wherein the functional accessory comprises
(a) a sensor adapted to monitor one or more of the following
parameters: CO.sub.2 concentration, O.sub.2 concentration, N
concentration, anesthesia gas concentration, pressure, relative
humidity, temperature and gas flow rate, and/or (b) an end-tidal
CO.sub.2 adaptor for monitoring end-tidal CO.sub.2 from a nose
and/or mouth of a wearer, and/or (c) a CO.sub.2 scavenger, a gas
collector or exhalation scoop, and/or (d) a nasal cannula, and/or
(e) suction tubing, and/or (f) an oral mask adapted to accommodate
a functional device, and/or a laryngoscope, a video laryngoscope,
an endotrachael tube, a fiber optic bronchoscope, a rigid
bronchoscope, a gastroenterology scope, and/or an exhalation scoop
or exhaled breath scavenger mounted adjacent a lower portion of the
mask positioned to overly a region of an upper lip of a patient
when the mask is worn, wherein the exhalation scoop is attached to
the nasal mask through the attachment ports that optionally permit
exhaled breath captured by the exhalation scoop to be diverted into
the nasal mask.
4. The mask of claim 3, wherein the exhalation scoop or exhaled
breath scavenger is integral to the mask, or fixed to the mask by
mechanical or adhesive attachments or brackets.
5. The mask of claim 1, wherein the functional accessory is one of
an oral mask, a sensor, a gas scavenger, a gas collector, an
exhalation scoop, a nasal cannula, end-tidal CO.sub.2 port, a
nebulizer port, a PEEP valve port, expiratory port and/or valve,
and a pressure relief valve.
6. A nasal mask which can be used separately, or with an oral mask
attached to the nasal mask through a closable opening in the nasal
mask, comprising a sensor or sensors interior to the nasal mask
and/or the oral mask, adapted to measure one or more of the
following parameters: CO.sub.2 concentration, N concentration,
anesthesia gas concentration, pressure, relative humidity,
temperature and gas flow rate within the nasal and/or oral
masks.
7. The mask of claim 1, usable as a CPAP mask having an exhaust
optionally open to atmosphere, said mask being convertible from a
nasal CPAP mask to a full face mask CPAP mask and vice versa,
wherein the mask has a circuit port and an exhaust port, one or
more attachment valves and an adaptor for connecting a PEEP valve
and supplemental oxygen to the mask.
8. The mask of claim 7, wherein an oral mask is attached to the
nasal mask through the at least one self-closing valve.
9. The mask of claim 8, wherein the at least one self-closing valve
comprises at least one duck bill valve for engagement by at least
one proboscis of the oral mask when attached to the nasal mask.
10. The mask of claim 1, wherein the mask is disposable or
reusable.
11. The mask of claim 1, usable as a CPAP mask for use as a manual
resuscitation device having an exhaust port, which port can be
covered and allow pressure to build up within the device or
uncovered and open to atmosphere and allow for pressure drop, which
enables exhalation, said mask being convertible from a nasal CPAP
mask to a full face mask CPAP mask and vice versa.
12. The mask of claim 11, wherein the mask comprises a nasal mask
and an oral mask, said nasal mask having a circuit port and an
exhaust port, one or more attachment valves and an adaptor for
connecting a PEEP valve and supplemental oxygen to the nasal
mask.
13. The mask of claim 12, wherein the oral mask is attached to the
nasal mask through the at least one self-closing valve.
14. The mask of claim 13, wherein the at least one self-closing
valve comprises at least one duck bill valve for engagement by
proboscises of the oral mask when the oral mask is attached to the
nasal mask.
15. A nasal mask comprising a generally triangularly-shaped frame
having an apex forming a nasal bridge region connected by slanted
side walls to a lip region, said nasal mask including a y-shaped
perimeter seal, a nasal bridge seal formed of an elastic membrane
bridging the nasal bridge region and the side walls, and/or a lower
lip seal formed of an elastic membrane bridging the lower lip
region and adjacent portions of the side walls, for accommodating
patient lips of various sizes and shapes.
16. The nasal mask of claim 15, wherein the Y-shaped perimeter seal
has a durometer selected from the group consisting of 2-10, 3-7,
and about 5 measured on the Shore A Hardness scale.
17. The nasal mask of claim 15, further including a port for
connection to a suction source.
18. A method for ventilating a patient, comprising: applying a
nasal mask having one or more attachment ports for supporting a
functional accessory, sealable by at least one self-closing valve,
a septum, a frangible membrane, a plug or a cap, located adjacent
to and overlying a region of an upper lip of a patient when worn,
over the patient's nose; and monitoring one or more of the
following parameters: (a) CO.sub.2 concentration, O.sub.2
concentration, N concentration, anesthesia gas concentration,
pressure, relative humidity, temperature and gas flow rate using a
sensor on or in the mask, and/or (b) end-tidal CO.sub.2 using an
adaptor and/or sensor on or in the mask for monitoring end-tidal
CO.sub.2 from the nose and/or mouth of the wearer, and/or (c)
CO.sub.2 using a CO.sub.2 scavenger, gas collector or exhalation
scoop on or in the mask.
19. The method of claim 18, wherein the mask is used in combination
with a functional device selected form the group consisting of a
laryngoscope, a video laryngoscope, an endotrachael tube, a fiber
optic bronchoscope, a rigid bronchoscope, and a gastroenterology
scope.
20. The method of claim 18, wherein end-tidal CO.sub.2 is collected
from a patient using an exhalation scoop or exhaled breath
scavenger mounted adjacent a lower portion of the mask positioned
to overly a region of an upper lip of a patient when the mask is
worn, wherein the exhalation scoop is attached to the nasal mask
through the attachment ports that optionally permit exhaled breath
captured by the exhalation scoop to be diverted into the nasal
mask.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 15/127,759, filed Sep. 20, 2016, which is turn claims priority
from PCT Patent Application Serial No. PCT/US16/37070 filed Jun.
10, 2016, which claims priority from U.S. Provisional Application
Ser. No. 62/174,410, filed Jun. 11, 2015, and from U.S. Provisional
Application Ser. No. 62/253,512, filed Nov. 10, 2015, and from U.S.
Provisional Application Ser. No. 62/204,899, filed Aug. 13, 2015,
and from U.S. Provisional Application Ser. No. 62/253,520, filed
Nov. 10, 2015, and from U.S. Provisional Application Ser. No.
62/245,794, filed Oct. 23, 2015, and from U.S. Provisional
Application Ser. No. 62/245,810, filed Oct. 23, 2015, and from U.S.
Provisional Application Ser. No. 62/253,528, filed Nov. 10, 2015,
and from U.S. Provisional Application Ser. No. 62/255,120, filed
Nov. 13, 2015, and from U.S. Provisional Application Ser. No.
62/286,165, filed Jan. 22, 2016, and from U.S. Provisional
Application Ser. No. 62/298,265, filed Feb. 22, 2016, and from U.S.
Provisional Application Ser. No. 62/298,295, filed Feb. 22, 2016,
and from U.S. Provisional Application Ser. No. 62/324,197, filed
Apr. 18, 2016, and from U.S. Provisional Application Ser. No.
62/301,359, filed Feb. 29, 2016, and from U.S. Provisional
Application Ser. No. 62/308,127, filed Mar. 14, 2016, and from U.S.
Provisional Application Ser. No. 62/319,686, filed Apr. 7, 2016,
the contents of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to improvements in anesthesia
masks and ventilation masks.
[0003] During surgery a patient usually is placed under anesthesia.
The most common delivery system consists of canisters containing
anesthesia gases and oxygen, a system of regulating the gas flow
and the patient's breathing, and a device ensuring the potency of
the patient's airway for breathing, oxygenation and the delivery of
the anesthetic gas mixture. A ventilation mask is used to provide
oxygen to the patient either during emergency and/or elective
airway management, which includes but is not limited to: before a
patient is anesthetized for surgery; while the patient is sedated
during the surgery or procedure; while the patient is recovering
from anesthesia; after the patient has recovered from anesthesia;
and during any event where a patient requires supplemental oxygen.
However, conventional ventilation masks are less then ideal.
[0004] Moreover, situations may arise during surgery that require
rapid intubation of a patient. Full face masks, i.e. masks covering
both the nose and mouth of a patient are problematic in emergency
situations since a mask must be removed to uncover the mouth of a
patient for intubation. However, removing the mask also removes
oxygen support.
[0005] In our co-pending PCT Application Serial Nos.
PCT/US2014/44934, PCT/US2015/034277 and PCT/US2015/044341
(hereinafter the '934, '277 and '341 PCT applications), we provide
improved ventilation/anesthesia masks that overcome the aforesaid
and other problems with the prior art by providing, in one aspect,
a combination mask comprising a nasal portion or mask and an oral
portion or mask defining respectively a nasal chamber and an oral
chamber, detachably connected to one another wherein the nasal mask
may be used separately or connected to the oral mask as a
combination nasal/oral mask. We also provide the nasal mask with
one or more ports, and various strap systems for holding the mask
on a patient's face. Such combination nasal/oral masks are
available commercially from Revolutionary Medical Devices, Inc. of
Tucson, Ariz., under the trademark SuperNO.sub.2VA.RTM..
SUMMARY OF THE INVENTION
[0006] The present invention in one aspect provides nasal
ventilation mask having one or more attachment ports located
adjacent to and overlying an upper lip of a patient when worn.
[0007] Preferably the attachment ports are sealable by a
self-closing valve, preferably a duckbill valve, a frangible
membrane, a plug or a cap, and are adapted to support a functional
accessory. In a preferred embodiment the functional accessory
comprises a sensor adapted to monitor one or more of the following
parameters selected from the group consisting of CO.sub.2
concentration, O.sub.2 concentration, N concentration, anesthesia
gas concentration, pressure, relative humidity, temperature and gas
flow rate; an end-tidal CO.sub.2 adaptor for monitoring end-tidal
CO.sub.2 from the nose and/or mouth of the wearer; or a sensor, a
CO.sub.2 scavenger, a gas collector or exhalation scoop, a nasal
cannula, and/or an oral mask adapted to accommodate a functional
device, preferably a laryngoscope a video laryngoscope, an
endotrachael tube, a fiber optic bronchoscope, a rigid
bronchoscope, a gastroenterology scope and/or suction tubing.
[0008] The present invention in another aspect provides a
ventilation mask having upper and lower portions and/or left and
right portions connected by an elastomeric hinge or bridge. In such
aspect the mask maybe a full face mask, an oral mask, a nasal mask
or a combination nasal/oral mask connected to one another. In such
aspect the clastomeric hinge or bridge has an ability to rotate
around the x and/or y and/or z direction. In a particularly
preferred embodiment the mask comprises a combination nasal/oral
mask in which the nasal portion of the mask and the oral portion of
the mask are separable from one another.
[0009] The present invention in another aspect provides a nasal
mask comprising an exhalation scoop mounted adjacent a lower
portion of the mask positioned to overly an upper lip of a patient
when the mask is worn, wherein the exhalation scoop is attached to
the nasal mask through attachment ports that permit exhaled breath
captured by the exhalation scoop to be diverted into the nasal
mask, and a port for connection to a suction source.
[0010] The present invention in yet another aspect provides an
anesthesia mask comprising a nasal mask adapted to seal to a
patient's face when worn by a patient, and an exhaled breath
scavenger attached to the mask adjacent its lower side which
overlies an upper lip of a patient when the mask is worn by the
patient. In such aspect the exhalation scoop or exhaled breath
scavenger preferably is fixed to the mask by mechanical or adhesive
attachments or brackets.
[0011] The present invention also provides a nasal mask comprising
a generally triangularly-shaped frame having an apex forming a
nasal bridge region connected by slanted side walls to a lip
region, said nasal mask including a nasal bridge seal formed of an
elastic membrane bridging the nasal bridge region and the side
walls, and optionally including a lower lip seal formed of an
elastic membrane bridging the lower lip region and adjacent
portions of the side walls, for accommodating patient lips of
various sizes and shapes, or in the alternative, only a lip seal
formed of an elastic membrane bridging the lip region and the side
walls.
[0012] In yet another aspect there is provided a breathing circuit
for delivering oxygen and/or anesthetic gases through a mask to a
patient, comprising a fresh gas supply line connected either
directly to a mask or indirectly to the mask through a
non-breathing circuit port, and an exhalation collecting tube
connected between the non-breathing circuit port and a flexible
reservoir bag, wherein the mask comprises a nasal ventilation mask,
a full face mask with a valved connector or membrane seal, or a
combined nasal/oral mask in which the oral mask is detachable. In
such aspect, a first end of the fresh gas line preferably is either
directly or indirectly connected to the mask, while a second end is
connected to the fresh gas supply. Also, preferably the flexible
reservoir bag defines a passageway for flow of gas in a first
direction, said bag having a gas outlet and inlet, wherein the bag
outlet is in communication with the exhalation collecting tube,
which defines a passageway for flow of gas in a first and a second
direction, wherein at least part of the walls of the bag preferably
extend beyond sides of the exhalation collecting tube, and the
first and second directions of gas flow are substantially parallel
to, and laterally offset from, one another, and/or wherein the
exhalation collecting tube is affixed to an outer surface of the
reservoir bag.
[0013] Also provided by the present invention is a breathing
circuit for delivering oxygen and/or anesthetic gases through a
mask to a patient, wherein the mask comprises a full face mask,
which includes a valved connector or membrane seal for maintaining
positive pressure while simultaneously allowing passage of a
functional tool into the mouth of a patient. In such embodiment,
the functional tool may comprise, for example, a laryngoscope, a
video laryngoscope, an endrotracheal tube, a fiberoptic
bronchoscope, a rigid bronchoscope, a gastroenterology endoscope,
and/or suction tubing. Optionally included is a portable oxygen
tank for transportation of the patient from one location to
another, or connected to supplemental wall oxygen used in an
operating room, or used in procedural room such as a GI suite,
cardiac catheter lab, MRI, and bronchoscopy suite.
[0014] The present invention in another aspect provides a breathing
circuit for delivering oxygen and/or anesthetic gases through a
mask to a patient, wherein a fresh gas line is connected to a
exhalation collecting tube, and the exhalation collecting tube is
connected to a two chamber ventilation facemask, including an oral
chamber and a nasal chamber, wherein the oral chamber is removable
allowing the nasal chamber to stay on the patient for providing
nasal CPAP and nasal NIPPV, while simultaneously allowing a surgeon
access to the patient's mouth to perform a procedure.
[0015] In yet another aspect there is provided a breathing circuit
for delivering oxygen and/or anesthetic gases through a mask to a
patient, where a fresh gas line is connected to an exhalation
collection tube, and an exhalation collecting tube is connected to
a nasal mask for use in nasal CPAP and nasal NIPPV, said
non-rebreathing breathing circuit further comprising a separate
oral mask, having one or more ports which contain either one-way
valved connectors or membrane seals that allow passage of a
functional tool.
[0016] In such aspect the functional tool preferably comprises a
video laryngoscope/laryngoscope, an endrotracheal tube, and/or a
fiberoptic bronchoscope with an endotrachcal tube attached or a
suction tool; the oral mask optionally preferably includes a port
for scavenging gases; the exhalation collecting tube optionally
preferably includes an end-tidal CO.sub.2 port for connection to an
end-tidal CO.sub.2 monitor; and, the exhalation collecting tube
optionally preferably includes--bacterial filters.
[0017] The present invention in yet another aspect provides a
disposable CPAP mask having an exhaust optionally open to
atmosphere, said mask being convertible from a nasal CPAP mask to a
full face mask CPAP mask and vice versa. In such aspect, the nasal
CPAP mask preferably comprises a nasal mask having a circuit port
and an exhaust port, one or more attachment valves and an adaptor
for connecting a PEEP valve and supplemental oxygen to the mask,
optionally including a removable oral mask, and wherein the one or
more attachment valves preferably comprise duck bill valves for
engagement by proboscises of an oral chamber when attached to the
nasal chamber.
BRIEF SUMMARY OF THE DRAWINGS
[0018] Further features and advantages of the present invention
will be seen from the following detailed description, taken in
conjunction with the accompanying drawings, wherein:
[0019] FIG. 1 is a side view of a nasal mask in accordance with one
aspect of the present invention;
[0020] FIG. 2 is a perspective view and
[0021] FIG. 3 a plan view from the inside of the mask of FIG.
1;
[0022] FIG. 3A is a cross-sectional view taken along line 3A-3A
showing details of a Y-seal in accordance with a preferred
embodiment of the invention;
[0023] FIG. 4 is a top plan view and
[0024] FIG. 5 a side view of a hinged combination nasal/oral mask
in accordance with an embodiment of the present invention;
[0025] FIG. 6 is a schematic view of a nasal mask and sensor system
in accordance with another embodiment of the present invention;
[0026] FIG. 7 is an inside view of an embodiment of a combination
nasal/oral mask in accordance with the present invention with
sensors in the oral chamber;
[0027] FIG. 8 is a schematic view of a nasal mask with a CO.sub.2
collector and gas scavenger accessory in accordance with an
embodiment of the present invention;
[0028] FIG. 9 is a side elevational view of another embodiment of a
CO.sub.2 scavenger accessory in accordance with the present
invention;
[0029] FIG. 10 is a front plan view and
[0030] FIG. 11 a side view of still another embodiment of the
present invention;
[0031] FIG. 12 is a view similar to FIG. 8 of yet another
embodiment of the present invention;
[0032] FIG. 13 is an exploded perspective view of yet another
embodiment of the present invention;
[0033] FIG. 14A is a front view, and FIGS. 14B and 14C are cross
sectional views along sections A-A and B-B, respectively of yet
another embodiment of the present invention where an end tidal CO2
collector is integrated as part of the Nasal chamber;
[0034] FIGS. 15A and 15B are views similar to FIGS. 14A and 14C of
still yet another embodiment of the present invention where an end
tidal CO2 collector and gas scavenger are integrated as part of the
Nasal chamber;
[0035] FIG. 16A is a front view, FIGS. 16B and 16C side views, FIG.
16D an exploded view and FIG. 16E a rear view of yet another
embodiment of the present invention where an end tidal CO2
collector and gas scavenger are integrated as part of the nasal
chamber (FIGS. 16A and 16B), or formed separately and mounted to
the nasal chamber (FIGS. 16C-16E);
[0036] FIG. 17 is an exploded side elevational view of still yet
another embodiment of the present invention where a nasal cannula
accessory is inserted through the duckbill valves to provide
additional oxygen flow;
[0037] FIG. 18 is perspective view of another embodiment of the
invention in which a video laryngoscope blade is inserted through
the oral chamber;
[0038] FIG. 19 is a perspective view of another embodiment of the
invention in which a video laryngoscope blade and an endotracheal
tube are inserted through the oral chamber;
[0039] FIG. 20 is a schematic view showing yet another embodiment
of the invention including a respiratory nasal mask and breathing
circuit assembly;
[0040] FIG. 21 is a schematic view of yet another embodiment of the
invention comprising of a respiratory tube chamber (oral and nasal)
full face mask and breathing circuit assembly;
[0041] FIG. 22 is a schematic view of yet another embodiment of the
invention incorporating separate nasal and oral masks with a
breathing circuit assembly through the oral mask;
[0042] FIG. 23 is a schematic view of yet another embodiment of the
invention showing a respiratory nasal mask directly connected with
a fresh gas limb and breathing circuit assembly;
[0043] FIG. 24 is a schematic view of another embodiment of the
invention showing a two-piece full face mask and breathing circuit
assembly;
[0044] FIG. 25 is a perspective view of yet another embodiment of
the invention showing a nasal mask with a peep valve adaptor;
and
[0045] FIG. 26 is a view similar to FIG. 25, showing a two-piece
(nasal and oral) mask incorporating a peep valve adaptor.
DETAILED DESCRIPTION OF THE DRAWINGS
[0046] The present invention in one aspect is based on the
realization that the nasal portion or mask of the combination
nasal/oral mask as described in our aforesaid '934, '277 and '341
PCT applications, not only can be used separately as a nasal mask
for nasal ventilation, but also as a platform for connecting other
devices, attachments and accessories, to the nasal mask including
other types of oral chambers for accommodating, for example,
laryngoscopes, bronchoscopes, CO.sub.2 scavengers, and adaptors and
sensors for measuring, for example, O.sub.2 or nitrogen
concentrations, anesthesia gas concentration, end tidal CO.sub.2,
etc., as will described below.
[0047] However, before describing the other devices, attachments
and accessories, we will describe various structural improvements
to the nasal mask and the combination nasal/oral mask such as
described in our aforesaid '934, '277 and '341 PCT
applications.
[0048] Referring to FIGS. 1-3, a nasal mask in accordance with the
present invention provides a generally triangularly shaped shell
having a relatively rigid body portion 60 formed of a transparent
polymeric material. A multi-lobed, preferably Y-shaped seal 62 is
fixed to rigid body 60 at 70. Seal 62 includes a nose bridge region
64 provided adjacent the "apex" area of triangularly shaped body
60. Seal 62 is formed of a resiliently deformable material
preferably having a Shore A Hardness durometer of 2-10, more
preferably 3-7, most preferably about 5. In order to provide a
better seal for patients with different bridge heights and shapes,
a nasal bridge seal in the form of an elastic membrane-like seal
structure 100 is provided spanning the right side 112 and left side
114 of the mask terminating at the inside edge of seal 120. Seal
100 which preferably is formed integrally with seal 62, is thinned
to a thickness of 0.04 to 9.7 mm, preferably 1 to 5 mm, most
preferably about 2 mm. Being quite thin, and being formed of a
resiliently deformable material, seal 100 readily deforms and
stretches to intercept and conform to the nose of the patient.
Thus, if there is a gap 130 at the top of the bridge as shown in
FIG. 1, the clinician may slightly deform body 60 the nasal chamber
(which is significantly more rigid than the elastic membrane 100),
whereby to deform the elastic membrane-like nasal bridge seal, so
that the edge of the nasal bridge seal 100 indicated by the dotted
line 118 intercepts a lower portion of the patient's nose. Because
seal 100 is attached to the nasal chamber perimeter seal 120, this
allows the nasal chamber 116 to better seal to the patient's
nose.
[0049] In a similar manner, a lower lip seal 140 may be provided in
the form of a thin elastic membrane spanning the lower portion
perimeter seal 120, and has a similar effect of accommodating
patients having different size and shape lips, and sealing the
nasal chamber even if there was a gap. In various embodiments we
provide a nasal bridge seal 100, a lower lip seal 140 or both nasal
bridge and lower lip seals 100, 140.
[0050] While the invention has particular utility for use with
combination the nasal portion of a nasal-oral mask such as
described in our aforesaid '934, '277 and '341 PCT applications,
the nasal bridge seal 100 and/or lower lip seal 140 advantageously
also may be used with conventional nasal masks or full
facemasks.
[0051] The present invention, in another aspect, provides
improvements to the combination nasal-oral mask such as described
in our aforesaid '934, '277 and '341 PCT applications, by providing
a hinge that allows for relative movement/positioning between the
upper nasal chamber and the lower mouth or oral chamber, for better
conforming to a patient's face.
[0052] Accordingly, in order to accommodate different size/shape
faces, we have separated the nasal chamber 200 and the oral chamber
210 into upper and lower portions as shown in FIGS. 4 and 5. The
upper and lower portions are connected by an elastomeric hinge 220
or bridge or expansion joint that maintains a seal and yet allows
the nasal chamber 200 and the oral chamber 210 to rotate in either
direction about the X axis as shown in FIGS. 4 and 5. This rotation
allows the perimeter seal to better engage with the nasal bridge
and/or the lower lip of the patient. Also, a vertically running
elastomeric bridge or hinge or expansion shown in phantom at 222,
i.e. connecting the left 224 and right 226 sides of the mask, may
be employed in place of or in addition to the elastomeric hinge or
bridge connecting the nasal and oral portions of the mask.
[0053] While out invention is particularly useful in connection
with a combined nasal/oral mask as described in our aforesaid '934,
'277 and '341 PCT applications, the invention also advantageously
may be employed with conventional masks including full face and
nasal masks.
[0054] As noted supra, the nasal portion or mask, as above
described also provides a platform for supporting various
functional attachments and accessories. One such functional
accessory is shown in FIG. 6, and comprises an integrated sensor
system 230 including one or more sensors 231 carried on proboscises
231 for sensing, e.g., gas identification and concentration levels
including, e.g., O.sub.2 concentration, CO.sub.2 concentration,
N.sub.2 concentration, anesthesia gas concentration, pressure,
relative humidity, temperature and/or gas flow rate, within or
adjacent an inner surface and/or outer surface of a ventilation
mask 232 and connected to a circuit/controller 234, for monitoring
the gas, etc., within or adjacent the mask 232. Preferably the mask
comprises a nasal mask with valved ports 235 such as duckbill
valves as described in our aforesaid '934, '277 and '341 PCT
applications. However, other types of valve mechanisms, or open
ports with removable plugs or frangible membranes may be used in
place of the duckbill valves. The integrated sensor system within
the mask 232 allows sensing of the mask interior environment.
Preferably the accessory includes communication capabilities in the
form of a circuit/controller 236 and connector 240 that connects to
a local amplifier 238 which may include an analog to
digital/digital to analog converter. Signals from the sensor system
are transmitted to a circuit/controller 234 resulting in a closed
or an open loop command that may then be sent to an anesthesia
machine, ventilator or other respiratory device 244 to adjust
pressure, and various gas properties such as temperature,
anesthesia or oxygen concentration and humidity level. The
integrated sensor system also may include a local controller 237
for providing local housekeeping, calibration and control
functions, etc.
[0055] Referring to FIG. 7 multiple sensors 250, 252 could be
placed at different locations within or adjacent the mask inner
surface to monitor the inner chamber environment, below the
patient's nose where the nasal chamber duckbill valves 260 and the
oral chamber 260 proboscis interface, or at other locations. As
before, a controller 254 for housekeeping calibration or other
functions also could reside in the chamber. All sensor power, data
and or control interface may occur through connector 240.
[0056] Various other sensors for measuring the above listed and
other parameters may be included. The sensors may be (1) resident
on an inside of a nasal chamber and/or oral chamber of a
combination nasal-oral mask as described above; (2) resident on an
inside and also an outside of the nasal chamber; (3) provided as a
sensor assembly that plugs into ports of a nasal mask; and/or (4)
resident in an oral mask part of a nasal/oral mask combination,
without impacting exchange through a connection between the nasal
and oral mask portions.
[0057] Also provided is a ventilation mask monitor having a local
amplifier to amplify sensor signals from one or more of the above
sensors, for delivery to a controller, and a ventilation mask
monitor including gas sensors, having a power controller for
providing filtered power to the sensors and local processor; a
ventilation mask gas monitoring system including an Analog to
Digital and Digital to Analog signal converter; and a controller
for monitoring sensor signals and closing a loop by sending signals
to the hardware associated with the airway for one or more of the
above parameters.
[0058] A feature and advantage of the present invention which
results from the placement of a sensor assembly including CO.sub.2
or other gas monitors directly within or adjacent an inner surface
of a ventilation mask is the ability to monitor the inner chamber
environment of the ventilation mask in real time.
[0059] Shown in FIG. 8 is a nasal mask which in a preferred
embodiment is the nasal portion of a combination nasal-oral mask
such as described in our aforesaid '934, '277 and '341 PCT
applications, incorporating a sensor assembly 314 which is plugged
into the valved ports 310 of the nasal mask 312. Referring also to
FIG. 9, the sensor assembly 314 includes a proboscis pair 316 sized
and shaped to engage with the valved ports 310 of the mask 312.
Sensor assembly 314 includes a plurality of sensor elements 315 for
monitoring CO.sub.2 and other gas levels such as O.sub.2, nitrogen,
anesthesia gas concentrations, humidity, etc. Also, if desired, an
additional sensor element 315A could be placed exterior to the
sensor assembly 314 just above the upper lip of the patient to
monitor oral respiratory functions including end tidal
CO.sub.2.
[0060] Sensor assembly 314 engages through the valved ports 310 of
the nasal mask 312 to access the nasal chamber interior region and
to sit over the patient's upper lip as shown in FIG. 8. When so
engaged, the sensor assembly 314 is in direct contact with the
interior nasal chamber environment at the top region of the
proboscis pair 316. A communication and powerline 320 interfaces
with the sensor assembly 314. All sensor elements are
interconnected for power, data and control. A description of the
sensor elements on the interior to the carrier and proboscis
exterior, and partially exterior in the case of sensor element
315A, is provided in Table 1 below:
TABLE-US-00001 TABLE 1 Nasal Chamber Numbered Elements Element #
Name Comment 315/315A Sensor One or multiple sensors that monitor
the interior nasal chamber environment when mounted at the tip or
interior of the proboscis, or the environment above the patient's
lip. These sensors can monitor one or more properties, but not
limited to: 1. Gas Identification and Concentration levels
including: CO.sub.2 concentration O.sub.2 Concentration N
Concentration Anesthesia gas concentrations 2. Pressure 3. Relative
Humidity 4. Temperature 5. Gas flow Rate 322 Amplifier/ Provides
local sensor signal amplification and filtering and/or analog
Converter/ to digital conversion and/or digital to analog
conversion and/or digital Data to digital communication to elements
within the Sensor Assembly and Interface external devices. 324
Local A local controller could be resident within the assembly to
provide for Controller local housekeeping, calibration and control
functions
[0061] The sensor assembly provides open and closed loop control of
respiratory systems including ventilators, anesthesia machines,
CPAP machines, high-flow oxygen and humidification sources.
[0062] If a full facemask is desired, composed of a combination
mask including both nasal and oral chambers, an alternate
configuration is to have a sensor assembly similar to the sensor
assembly described integrated into the oral chamber of the
combination mask. The sensor assembly as above described also
advantageously may be used in connection with a conventional full
face mask.
[0063] In yet another aspect of the invention, illustrated in FIG.
9, a functional accessory in the form of an end-tidal CO.sub.2
sample line adaptor 350 is provided, which attaches to a nasal mask
having valved ports such as duckbill valves as described in our
'934, '277 and '341 PCT applications. Sample line adaptor 350
allows end-tidal CO.sub.2 monitoring from both the nose and the
mouth simultaneously. Preferably sample line adaptor 350 comprises
a branched tubing 352, having one or more prongs or proboscises
354, 356 with one or more openings 358. The branched tubing 352 has
a line 360 with a luer lock 362 that connects through a standard
luer lock 364, which connects to an end-tidal CO.sub.2 sample line
366 to monitor end-tidal CO.sub.2. The distal end of the branched
tubing 352 has two ends with two prongs or proboscises 354, 356,
where one prong 356 has a solid proximal end 370 and inserts
through the nasal mask's valved ports allowing them to open up,
whereby to permit sampling of, e.g., CO.sub.2 from the nose. The
other end of the branched generally y-shaped tubing 360 has a solid
distal end 372 and an open side or slit 374, located on the outside
of the nasal mask, near the mouth for sampling CO.sub.2 expelled
from the patient's mouth.
[0064] The current invention is advantageous in that it can monitor
end-tidal CO.sub.2 from a patient's nose and mouth, while allowing
for positive pressure ventilation to occur, and without obstructing
either the mouth and/or the view of the patient's airway. This is
important because many procedures such as EGD, TEE, and
laryngoscopy require the clinician have access to the patient's
mouth. Preferably adaptor 350 is thin, and located just above the
mouth, so as to not interfere with procedures, or the doctor's
view. The invention also permits positive pressure ventilation
without effecting end-tidal CO.sub.2 monitoring.
[0065] Another embodiment of our invention is shown in FIGS. 10-11.
Referring to FIGS. 10-11, in order to better collect end tidal
CO.sub.2 samples from a patient's exhaled breath, a functional
accessory in the form of an exhalation scoop 400 that is part of a
nasal chamber adaptor 402 is added to a nasal chamber 404. In one
embodiment, the nasal chamber 404 is the chamber portion of a
combination nasal-oral mask such as described in our aforesaid
'934, '277 and '341 PCT applications. Adaptor 402 has a proboscis
pair 406 which engage the valved ports in the nasal chamber 404,
which permits collection of nasal exhalation through the proboscis
and oral exhalation through the exhalation scoop 400 adjacent the
patient's lips. Exhalation scoop 400 directs exhaled breath towards
a suction element 410 of a CO.sub.2 port when connected to a
suction source (not shown). Exhalation scoop 400 preferably is
generally perpendicular to the plane created by the patient's lower
lip, but may be curved to divert the patient's breath towards the
nasal chamber 404.
[0066] An extended exhalation scoop 406 that has a length beyond
both lips also may be desired in order to capture more of the oral
exhalation gases, as shown in the FIG. 11.
[0067] Additionally, in order to better scavenge exhaled gas or
scavenge exhaled gas and end tidal CO.sub.2 from a patient's
exhaled breath, an exhalation scoop 412 may be formed as an
integral part of the nasal chamber (see FIG. 11).
[0068] Exhalation scoop 400, 406 may be rigid, or somewhat flexible
to provide access to a user's mouth.
[0069] Referring to FIGS. 12-13 another functional accessory in the
form of oral scavenging adaptor 502 is illustrated in which the
nasal mask 500 has one or more attachment sites 504, to which an
oral scavenging adaptor 502 is connected via ports 506. Preferably
the nasal mask comprises a nasal mask portion of the combination
nasal/oral combined mask as described in our aforesaid '934, '277
and '341 PCT applications, and the attachment sites 504 are valved
ports. However, the oral scavenging adaptor 502 also advantageously
may be employed in connection with other, more conventional nasal
masks, and may be formed integrally with the mask, or affixed to
the mask by adhesive or mechanical fasteners, hook and loop, etc.
In a preferred embodiment, the oral scavenging adaptor 502 consists
of a hollow member, having an opening 520 on the bottom, and
suction tubing 516, connecting the oral scavenging adaptor 502 to a
suction or vacuum source 514.
[0070] Referring in particular to FIG. 13, in a preferred
embodiment, the nasal mask 500 comprises the nasal mask portion of
a SuperNO.sub.2VA.RTM. mask available from Revolutionary Medical
Devices of Tucson, Ariz., and includes ports including a pair of
female ports 506 including duckbill valves, and the oral scavenging
adaptor 502 comprises one and preferably two closed proboscises 508
sized and shaped to be inserted into the duckbill valves of the
nasal mask 500. An opening or port 512 on the lower side oral
scavenging adaptor 502 is provided for suctioning anesthetic gases
and CO.sub.2 which may leak from the patient's mouth. A suction
connector 514 connects to suction tubing 516, which in turn
connects to wall suction and actively scavenges anesthetic
gases.
[0071] In a particularly preferred embodiment, the oral scavenging
adaptor 502 also includes an end-tidal carbon dioxide monitor
(ET-CO.sub.2 monitor), for monitoring ET-CO.sub.2 from within the
nasal mask 500, or the oral scavenging adaptor 502, or both.
[0072] As before, while the oral scavenger as above described
advantageously may be used with the nasal mask portion of a
SuperNO.sub.2VA mask, the oral scavenger adaptor also may be fixed
to a conventional nasal mask, using for example, a mechanical
fastener, hook and loop fasteners, an adhesive, etc., or the oral
scavenger adaptor could be integrally formed as a part of a
conventional nasal mask. This allows the clinician to help
determine whether or not nasal CPAP that is being applied is
effective.
[0073] Still yet another embodiment of our invention is illustrated
in FIGS. 14A-14C. A nasal mask 610 includes a CO.sub.2 port 618
formed as an integral part of the nasal chamber 610 and one or two
mounting ports 612, 614. Ports 612, 614 have barriers 616, that
separate the pressure environment within the nasal chamber 610,
P.sub.NC, from the ambient pressure environment where the patient's
lips are located, P.sub.Amb. This provides a seal so that the nasal
chamber interior may be pressurized at a level that is greater than
ambient. CO.sub.2 port 618 intersects the port 612 at barrier 616.
The intersection of the CO.sub.2 port 618 at barrier 616 can be
adjusted such that the area that provides an opening to the
interior of the nasal chamber environment, A.sub.Nasal, and the
area providing an opening to the ambient environment of the oral
region, A.sub.Oral, can be sized to adjust the level of flow from
zero flow to full flow based on suction source negative pressure,
P.sub.SS from the nose and mouth accordingly
(P.sub.SS<P.sub.Amb<P.sub.NC). A flow would occur when the
end of the CO.sub.2 port 618 is attached to a suction and sampling
device such as a CO.sub.2 monitor 622. The open end of the CO.sub.2
port 618 is connected to the suction source by a tube or pipe 624.
This configuration allows the nasal chamber to be maintained at
adequate positive pressure while still allowing sampling end tidal
CO.sub.2 that is being expired from the nose and the between the
lips. Additionally, this configuration provides the benefit that if
anesthetic gasses are being expelled from the mouth, some or all of
those gasses will be scavenged through the oral port when connected
to a suction source such as a CO.sub.2 monitor 622.
[0074] An alternate configuration shown in FIGS. 15A and 15B adds
as a functional accessory an integrated gas scavenger or collector
626 that attaches to a suction source 628 that is used to scavenge
anesthetic gases. A configuration with only the gas scavenger 626
also is possible. The gas scavenger 626 consists of a scavenger
port 630 that intersects the oral port 632 as shown in Section B-B
of FIG. 15A. In this configuration, only the ambient oral
environment called out as A.sub.Oral, will be exposed to the
suction source, resulting in the collection of expired gases from
the mouth by the suction source. The nasal chamber is blocked from
the suction source. The open end of the scavenger port 630 is
connected to the suction source 628 by a tube or pipe.
[0075] Incorporating a CO.sub.2 collector as part of a nasal mask
has several advantages. For one, the CO.sub.2 collector or
scavenger port does not obstruct access to or visualization of the
oral cavity of the patient. Also, the CO.sub.2 collector has a
secondary benefit that it may be used to scavenge anesthetic gases
expired from the mouth.
[0076] Alternatively, a CO.sub.2 collector such as an exhalation
scoop may be formed as an integral part of the nasal mask, to
sample end tidal CO.sub.2 from a patient's exhaled breath. FIGS.
16A and 16B illustrate front and side views, respectively, of an
exemplary exhalation scoop 640. The exhalation scoop 640 includes
one and preferably two closed proboscises 642 sized and shaped to
be inserted into the duckbill valves of the mask. Preferably
proboscises 642 are formed of a relatively rigid material for
engaging with the duckbill valves, while the main body 644 of the
exhalation scoop is formed of a relatively soft compliant material
so as to not injure or irritate the patient if it is pushed against
the patient's lips or teeth. Exhalation scoop extends from a
forward, lower surface of the oral ports of the mask and directs
the exhaled breath of the patient towards the suction element of
the CO.sub.2 port 650. Exhalation scoop 640 should be a gas
impervious barrier that directs flow of the exhaled gas from the
patient's mouth toward the collection suction provided by the
CO.sub.2 port when connected to a suction source. In an alternative
embodiment one or both proboscises 642 are hollow so that breath
collected by the exhalation scoop 640 may be diverted into the
nasal mask and a port on the nasal mask for connection to a suction
source. The exhalation scoop 640 may be located nominally
perpendicular to the plane created by the lower lip of the patient,
but preferably is curved to divert the breath towards the nasal
chamber.
[0077] Alternatively, as shown in FIGS. 16C-16E, an exhalation
scoop 660 may be formed separately with closed proboscises 662
sized and shaped to be inserted into the duckbill valves 664 of the
nasal mask 666. Preferably the proboscises 662 and main body 668 of
the inhalation scoop 660 are formed of a relatively rigid material,
while the distal portion of the exhalation scoop 660 is formed of a
relatively soft compliant material so as to not injure or irritate
the patient if it is pushed against the patient's lips or teeth.
Exhalation scoop 660 includes a CO2 port 672 which may be connected
to a suction source. In an alternative embodiment, one or both
proboscises 662 are hollow so that breath collected by the
exhalation scoop 660 may be diverted into the nasal mask and a port
on the nasal mask for collection to a suction source.
[0078] In yet another aspect, the present invention provides a
functional accessory in the form of an adapter for converting or
supplementing a nasal mask to/with a high flow nasal cannular
system. In one embodiment of the invention, illustrated in FIG. 17,
there is provided a high flow nasal cannula attachment piece 700
(nasal chamber to nasal cannula interface), which consists of a
male end 702 and a female end 704, where the female end 704
connects to a conventional high flow nasal cannula systems 706
(such as an OptiFlow.TM. nasal cannula available from Fisher &
Paykel Healthcare, or a VapoTherm.TM. nasal cannula available from
Vapotherm, Inc.), and the other end 702 attaches to the ports 720
on a nasal mask. Unlike conventional high flow cannulas which are
relatively soft so as to not damage a patient's tender nares, the
male end 702 of the high flow nasal cannula 700 attachment is made
sufficiently rigid or stiff distally to allow for penetration
through the duck valves in the ports 720 of the mask nasal chamber
712 to maintain patency of the valves. The male end 702 of the
nasal cannula should be made long enough to reach the nares of the
patient. Attachment piece 700 can either be used as an open system
by connecting to a nasal mask with a seal and leaving a circuit
port open, or be used as a closed system, connecting to nasal mask
with a seal, with its circuit connector connected to either a
ventilator, resuscitation bag, CPAP machine or PEEP valve, in order
create a positive pressure inside the mask or full facemask, and
allow for positive pressure ventilation.
[0079] Positive pressure also allows for relief of upper airway
obstruction and allows for institution of mask ventilation. With
this configuration, gas flows can be achieved that surpass the
capabilities of current high flow nasal cannula systems and are
over 100 L/min. e.g. through the mask inlet port 720.
[0080] Still other embodiments of the invention are illustrated in
FIG. 18-19 which illustrate the present invention with a functional
adaptor for an endotracheal tube or video larygoscope. Endotracheal
intubation is considered a dangerous procedure, since it is
performed without the patient receiving any oxygen or being
ventilated. The amount of time it takes to place an endotrachcal is
critical, as too long may cause the patient's oxygen saturation
levels to fall to life-threatening levels. Also, many times it may
take several attempts to place an endotracheal tube, at which point
a patient's oxygen saturation level may fall to life-threatening
levels (desaturation). Patients that are in respiratory failure who
need to be emergently intubated or patients that are morbidly obese
whose oxygen stores are quickly used up, may only have a few
seconds after they have received their last breath until their
oxygen saturation levels fall to life-threatening levels and their
heart goes into deadly arrhythmias.
[0081] The present invention provides a gas ventilation mask
comprising an anesthesia nasal mask 800 and a mouth mask 802
defining respectively a nasal chamber and an oral chamber, where
the nasal chamber is connected to a gas supply (mechanical
ventilator, anesthesia machine, oxygen supply source) and used to
provide oxygenation and ventilation and the oral chamber is used to
create a seal around the patient's mouth to prevent leakage of gas,
and accommodate a laryngoscope or other instrument as described
below.
[0082] The nasal mask portion may be a conventional nasal mask or
specialty nasal mask such as described in the aforesaid '934, '277
and '341 PCT Applications.
[0083] The oral mask portion has one or more ports 804, 806 which
contain either one-way valves such as duck bill valves (not shown)
similar to the duck bill valves described above for the nasal
masks, capped ports, or membranes 810 which allow the passage of,
e.g., a video laryngoscope, and handle, endotracheal tube, and/or
fiberoptic bronchoscope with an endotracheal tube attached 812 and
seals the video laryngoscope/laryngoscope, endotracheal tube,
and/or fiberoptic bronchoscope with an endotracheal tube 812 to
prevent any leakage of gas around them.
[0084] In use, the nasal mask 814 is placed over the patient's nose
and secured to the patient's head by a strap 808, which creates a
seal around the nose and prevents leakage of gas. One nasal mask
port 820 is connected to a gas supply where the gas supply is
pressurized and can be used to deliver oxygen and ventilate the
patient. In another embodiment a second port 822 can be used to
connect to a gas supply.
[0085] As noted supra, the oral mask may have one or more ports
804, 806, wherein each port is either a one-way valve or a membrane
that allows for the passage of, e.g., a video laryngoscope blade
812 and/or handle and either an endotracheal tube and/or a
fiberoptic bronchoscope with an endotracheal tube attached through
one or more ports and also creates a seal around the video
laryngoscope/laryngoscope blade and/or handle as well as the
endotracheal tube and/or the fiberoptic bronchoscope with the
endotracheal tube attached. The oral mask also covers and seals the
mouth, and is held in place by an oral chamber strap 810 preventing
any leakage of gas.
[0086] In one embodiment the oral mask has two ports, where one
port 804 allows for a video laryngoscope to pass through and seal
around it, while the second port 806 allows for either an
endotracheal tube and/or fiberoptic bronchoscope with an
endotracheal tube attached to pass through and seal around it to
prevent any leakage of gas. In yet another embodiment a third port
820, may be provided, for connection to a gas supply and allow the
oral mask to be pressurized and allow for oxygenation and positive
pressure ventilation.
[0087] In one embodiment, the oral chamber is adapted to attach and
seal to the video laryngoscope/laryngoscope. In a further
embodiment the oral chamber could be carried on the video
laryngoscope/laryngoscope.
[0088] In yet another embodiment, the oral chamber may be provided
with one or two extensions, which can be inserted into one or both
of the patient's nares and seal the nares, whereby to prevent
leakage of gases and eliminate the necessity for a sealed nasal
chamber as described above and illustrated in FIG. 17. In another
embodiment, a closed and pressurized system with one or more ports
allows for the delivery of oxygen positive pressure ventilation,
and monitoring of end-tidal carbon dioxide as described above.
Also, if desired, end-tidal carbon dioxide can be sampled and
monitored from one or more ports within either the oral chamber,
the nasal chamber, or both chambers, also as described above. Also,
for patients who are spontaneously breathing (i.e., breathing on
their own), the nasal chamber can be used to apply continuous
positive airway pressure (CPAP) to keep the patient's airway
patent, while the oral chamber prevents any gas from leaking out of
the mouth and maintains the pressure within the patient's
airway.
[0089] In a further embodiment, where the oral chamber occludes the
patient's nares and is connected to the pressurized gas supply,
when the patient is spontaneously breathing, CPAP can be used to
keep the patients airway patent (open).
[0090] In another aspect the oral mask includes a port through
which the endotracheal tube may pass, which can act as a guide when
passing the endotracheal tube into the trachea to facilitate
endotracheal intubation. In another embodiment, the oral chamber
has one or more ports which allow for the passage of an
gastroenterology endoscope and rigid bronchoscope while maintaining
a seal around them.
[0091] In yet another aspect there is provided a multi-port gas
ventilation mask system that allows for the passage of a video
laryngoscopy/laryngoscope, endotracheal tube, fiberoptic
bronchoscope, rigid bronchoscope, gastroenterology endoscope, and
suctioning tubing with an endotracheal tube, and which includes a
nasal mask and a mouth mask defining respectively a nasal chamber
and an oral chamber, where in the desired embodiment the mask seals
touch adjacent the top of the mouth, so that the nasal mask and the
mouth mask may be used separately with the nasal mask providing
oxygenation and ventilation, and the oral mask maintaining a seal
to provide a closed system. Also provided is a mask anchor for
holding a face mask on a patient, which includes a head support for
engaging a back of a patient's head, a posterior head strap that
originates from behind the patient's head, in contact with the
patient's head and attaches either directly or indirectly to the
mask when the mask is on the patient's face, wherein the strap can
be tightened to create a seal to allow for positive pressure
ventilation or left loose and for providing supplement oxygen. Also
provided is an anesthesia mask strap system having a first
expandable strap portion having the ability to extend; second and
third non-expandable strap sections fixed to ends of the first
expandable strap section; and an adhesion section for fixing a
length of the strap system when the second and third non-expandable
strap sections are pulled to tension the expandable strap
section.
[0092] Also, while the oral ventilation mask has been shown as
having a flexible membrane with ports for accommodating and scaling
around a laryngoscope and endotracheal tube, the membrane may be
formed of a flexible self-sealing material which the clinician may
puncture to introduce a laryngoscope or endotracheal tube, and
self-seal around the laryngoscope or endotracheal tube.
[0093] Other changes are possible. For example, a full face mask or
an oral only mask may be provided with a sealing membrane for
permitting introduction of a laryngoscope, or other instrument.
[0094] The present invention in yet another aspect provides
improvements in respiratory nasal and/or full face mask and
breathing circuit assemblies. Over the last decade the number of
moderate and deep sedation procedures have dramatically increased
(several million being performed annually). Sedation cases use
sedating medications in order to limit the patient from
experiencing both physical and psychological pain. However, these
sedating medications can cause relaxation of the muscles that help
maintain an open airway (i.e., upper airway obstruction), which can
lead to the airway becoming obstructed, inhibiting the patient from
breathing. Also, if a higher than expected dose of sedating
medication is given it can lead to respiratory depression.
[0095] Current practice recommends using a supplemental oxygen mask
and a carbon dioxide (CO.sub.2) monitor in order to try to maintain
a patient's blood oxygen levels at or close to oxygen saturation.
However, even with these devices, a patient may still suffer
life-threatening complications such as oxygen desaturation (low
blood oxygen levels).
[0096] Typically, a clinician would either apply a continuous
positive airway pressure (CPAP) mask over the patient's nose and
mouth to relieve a possible upper airway obstruction, or a
ventilation mask is placed over the patient's mouth and nose and
the patient is bag-mask ventilated using one of several
non-rebreathing breathing circuits (Mapleson, Bain, Magill and
Lack, Jackson Rees, etc). However, many procedures such as
endoscopy, transesophageal echocardiography (TEE), and bronchoscopy
require that the surgeon have access to the patient's mouth, which
prevents clinicians from being able to use this life-saving
technique. Thus, one of the major drawbacks to current
non-rebreathing breathing circuits is the fact that they are used
with a full ventilation facemask, which covers the patient's nose
and mouth.
[0097] The present invention provides an improvement over the
foregoing non-rebreathing breathing circuits and other prior art
breathing circuits and helps to solve the problem of patient's
desaturating and becoming apneic during moderate and deep sedation
procedures, by providing either nasal CPAP to relieve an upper
airway obstruction, or nasal NIPPV via a pressurized breathing
circuit connected to supplemental oxygen to nasally or
nasally/orally bag-mask ventilate.
[0098] More particularly, the present invention provides improved
breathing circuits, which includes but is not limited to
non-rebreathing breathing circuits, controllable partial
rebreathing anesthesia circuits, and a non-rebreathing anesthesia
circuits. Provided is a non-breathing breathing circuit comprising
a fresh gas supply line either directly connected to an exhalation
collecting tube or completely separate from the exhalation
collecting tube, where one end of the exhalation collecting tube is
connected to either a nasal ventilation mask, a two chamber (nasal
chamber with removable oral chamber) full ventilation facemask, or
a nasal ventilation mask with an oral seal/scavenger, and the other
end is connected to a flexible reservoir having bag walls. One end
of the fresh gas line can either be directly connected to the
exhalation collecting tube or it can be separately connected to the
nasal mask or full facemask, while the other end is connected to
the fresh gas supply. The bag defines a passageway for flow of gas
in a first direction. The bag has a gas outlet and inlet, where the
outlet is in communication with an exhalation collecting tube,
which defines a passageway for flow of gas in a second direction.
At least part of the walls of the bag extend beyond the sides of
the collecting tube, and the first and second directions of gas
flow are substantially parallel to, and laterally offset from, one
another. Alternatively, the exhalation collecting tube is attached
to an outer surface of the reservoir bag. The present invention
allows either a reusable or disposable non-rebreathing breathing
circuit to be connected to either a nasal mask, a full facemask, or
a nasal/oral mask configuration, which can be used to create a seal
to maintain positive pressure while simultaneously allow the
passage of a tool such as a video laryngoscopy/laryngoscope, an
endotracheal tube, a fiberoptic bronchoscope, a rigid bronchoscope,
gastroenterology endoscope, or suction tubing.
[0099] Thus, the present invention in another aspect provides a
breathing system, which can be used to deliver gases to a patient
via either the nose or both the nose and mouth using blow-by flow,
continuous positive airway pressure (CPAP), or non-invasive
positive pressure ventilation (NIPPV), and to remove gases exhaled
by the patient including CO.sub.2 and anesthetic gases via a
exhalation collection tube. The circuit may be used with an oxygen
tank for transportation of the patient from one location to
another, or connected to supplemental wall oxygen used in an
operating room, or in a procedural room such as a GI suite, cardiac
catheter lab, MRI, or bronchoscopy suite. A flexible reservoir bag
defines a passageway for flow of gas in a first direction, the bag
having a gas outlet and inlet, wherein the bag outlet is in
communication with the exhalation collecting tube which defines a
passageway for flow of gas in a first and a second direction. In
one embodiment of the invention, at least part of the walls of the
bag extend beyond sides of the exhalation collecting tube, and the
gas flow first and second directions are substantially parallel to,
and laterally offset from, one another.
[0100] The invention also provides a non-rebreathing breathing
circuit for delivering oxygen through a mask to a patient, which
may be either reusable or disposable, for connection to either a
nasal mask, a full face mask, or a nasal mask and oral mask set in
which the oral mask and nasal mask are separate from one another,
wherein the full face mask or the oral mask includes a valved
connector or membrane seal for maintaining positive pressure while
simultaneously allowing passage of a tool such as a video
laryngoscopy/laryngoscope, an endotracheal tube, a fiberoptic
bronchoscope, a rigid bronchoscope, gastroenterology endoscope,
and/or suction tubing to scavenge gases.
[0101] The present invention also provides a non-rebreathing
breathing circuit for delivering oxygen through a mask to a
patient, that can be used to deliver gases to a patient via either
the patient's nose or the patient's nose and mouth using blow-by
flow, continuous positive airway pressure (CPAP), or non-invasive
positive pressure ventilation (NIPPV), and to remove gases exhaled
by the patient via an oral scavenger or pressure release valve.
[0102] The above-described non-rebreathing breathing circuits may
be used in combination with a portable oxygen tank for
transportation of the patient from one location to another, or
connected to supplemental wall oxygen used in an operating room, or
used in procedural room such as a GI suite, cardiac catheter lab,
MRI, and bronchoscopy suite. In such embodiment a fresh gas line
and an exhalation collecting tube preferably are connected to a
nasal chamber portion of a full face two chamber combined nasal and
oral facemask, wherein the oral chamber is removable allowing the
nasal chamber to stay on the patient and to be used for nasal CPAP
and nasal NIPPV, while simultaneously allowing the surgeon access
to the patient's mouth to perform the procedure.
[0103] The present invention also provides a non-rebreathing
breathing circuit system for delivering oxygen through a mask to a
patient, where a fresh gas line and an exhalation collection tube
line is connected to a nasal mask for use in nasal CPAP and nasal
NIPPV, said system further including a separate oral mask, wherein
the oral mask has a valved connector or membrane seal that allows
passage of a tool such as a video laryngoscope/laryngoscope,
endotracheal tube, and/or fiberoptic bronchoscope with an
endotracheal tube attached and/or suction tubing.
[0104] In still yet another embodiment of the invention there is
provided a non-rebreathing breathing circuit for delivering oxygen
through a mask to a patient, wherein a fresh gas line and an
exhalation collection tube are directly connected to either a nasal
mask, a full facemask having a valved connector or membrane seal
that allows passage of a tool such as a tool such as a video
laryngoscope/laryngoscope, endotracheal tube, fiberoptic
bronchoscope with an endotrachcal tube and/or a suction tube, a
nasal mask/oral mask combination in which the oral mask is
separable from the nasal mask, or an oral mask and oral mask set in
which the oral mask and nasal mask are separate from one another,
wherein the oral mask has a valved connector or membrane seal that
allows passage of a tool such as a video laryngoscope/laryngoscope,
endotracheal tube, fiberoptic bronchoscope with an endotracheal
tube.
[0105] In various of the above embodiments the mask may include a
port for scavenging gases, an/or an exhalation collecting tube
including an end-tidal CO.sub.2 port for connection to an end-tidal
CO.sub.2 monitor, and/or filters for absorbing CO.sub.2.
[0106] Referring to FIG. 20 there is shown a non-rebreathing
breathing circuit, wherein a fresh gas line 912 is connected to an
exhalation port 914 of a nasal ventilation mask 920. An exhalation
collection tube 916 is also connected at one end to the exhalation
port 914, and at its other end to a reservoir bag 918. As so
constructed, the non-rebreathing breathing circuit permits nasal
CPAP and nasal NIPPV while simultaneously allowing a surgeon access
to the patient's mouth 922 to perform a procedure, i.e. allow
passage of a tool such as a video laryngoscope/laryngoscope, an
endotrachcal tube, a fiberoptic bronchoscope, a rigid bronchoscope,
a gastroenterology endoscope, or suction tubing, etc.
[0107] In another embodiment of the invention, shown in FIG. 21, a
fresh gas line 912 is connected to the exhalation port 914 of the
nasal mask 928, which nasal mask in turn is connected to a
removable oral ventilation mask 930 in accordance with our
aforesaid '934, '277 and '341 PCT Applications. With such
arrangement, the oral ventilation mask 930 may be removed, allowing
the nasal mask 928 to remain on the patient and used for nasal CPAP
and nasal NIPPV while simultaneously allowing the surgeon access to
the patient's mouth to perform a desired procedure, e.g. endoscopy,
etc. Also, with this embodiment, an end-tidal CO.sub.2 sampling
line 932 is connected to the exhalation port 914 of the nasal mask
928.
[0108] Yet another embodiment of the present invention illustrated
in FIG. 22 comprises a separate nasal mask 928 and oral mask 940.
The fresh gas line 912 is connected to the exhalation port 916 to
the nasal mask 920, as in the case of FIG. 20. In the illustrated
exhibit, the oral mask 940 comprises one or more ports 942 which
contain either one-way valved connector or membrane seal to
accommodate the passage of a endoscope or other tool such as a
video laryngoscope/laryngoscope, endotracheal tube, fiberoptic
bronchoscope, or suction tubing, etc. while at the same time
sealing the tool to prevent leakage of gas around the tool. The
oral mask 720 also can be used to scavenge exhalation gases.
[0109] Yet another embodiment of the present invention, shown in
FIG. 23 is similar to the nasal mask portion of the nasal mask/or
mask combination shown in FIG. 21. Still yet another embodiment of
the invention is illustrated in FIG. 24. In the FIG. 24 embodiment
the mask comprises an two-piece face mask including a nasal mask
950 and an oral mask 960, which includes a non-breathing circuit
port 952 and oxygen port 954, and includes one or mounting ports
956 which support an oral ventilation mask 960 similar to oral
ventilation mask 930 shown in FIG. 21. Alternatively, oral
ventilation mask 960 may be similar to oral ventilation mask 802
shown in FIG. 18, and include membrane seals to allow the passage
of a tool such as a video laryngoscope/laryngoscope, endotracheal
tube, fiberoptic bronchoscope with an endotracheal tube, suction
tool, etc to seal the tool to prevent leakage of gas around
them.
[0110] If desired, a separate end-tidal CO.sub.2 sampling line 958
and/or gas scavengers may be provided, connected to the
non-rebreathing circuit port collection tube 916.
[0111] A feature and advantage of the present invention is that the
fresh gas line 912 is completely separate from the exhalation line.
This allows for end-tidal CO.sub.2 monitoring through a port 952,
and also allows for an easier manufacturing, since the fresh gas
line will not have to be incorporated into the exhalation
collection tube.
[0112] Also, while the invention has been described in connection
with non-re-breathing breathing circuits, the invention also
advantageously may be used with controllable partial rebreathing
circuits, and non-rebreathing anesthesia circuits. The present
invention allows either a reusable or disposable non-rebreathing
breathing circuit to be connected to either a nasal mask, a full
facemask, or a nasal/oral mask configuration, which can be used to
create a seal to maintain positive pressure while simultaneously
allow the passage of a tool such as a video
laryngoscopy/laryngoscope, an endotracheal tube, a fiberoptic
bronchoscope, a rigid bronchoscope, gastroenterology endoscope, or
suction tubing.
[0113] In other embodiments the mask may be used with pressure
regulated or low flow CPAP; a full face mask can connect to a nasal
mask without losing pressure as an (1) attachment, (2) built into a
mask, or (3) with a ventilator or anesthesia machine.
[0114] Still yet other embodiments are possible. For example, a
bacteria or CO.sub.2 filter may be build into the mask connector.
Also, a pop-off valve with pressure relief may be provided at the
O.sub.2 port. Also, if desired, nebulized or aerosolized medication
may be injected via the O.sub.2 port. Also, the O.sub.2 port may be
provided with a 1-way valve for a person delivering breaths.
[0115] The present invention is the only full face mask that can
convert to a nasal mask for CPAP that can connect to supplemental
O.sub.2 tank, and the only positive pressure ventilation mask
providing high flow O.sub.2 capability utilizing O.sub.2 post and
ventilation post simultaneously with minimal leakage.
[0116] Finally, the present invention is a new configuration for a
disposable continuous positive airway pressure (CPAP) system.
Disposable continuous positive airway pressure (CPAP) systems
function by applying a continuous flow of gas (i.e.: oxygen) to a
closed and regulated system (i.e., a mask), which allows pressure
to be built up within the mask. This pressure is then transmitted
to a patient's airway and can be used to apply a continuous
positive airway pressure. This is typically used for patients that
have either Obstructive Sleep Apnea or an upper airway obstruction
from sedation.
[0117] The present invention is unique in that it can convert from
a nasal CPAP mask to full facemask CPAP mask and vise versa while
continuously maintaining pressure within the mask the entire time.
The configuration is also unique in that the nasal mask's
supplemental oxygen port can also be used as an exhaust port to
prevent the re-breathing of carbon dioxide.
[0118] In a preferred embodiment the nasal CPAP mask comprises a
nasal mask having a circuit port and an exhaust port, one or more
attachment ports and an adaptor for connecting a PEEP valve and
supplemental oxygen to the mask.
[0119] In another and preferred embodiment the one or more
attachment ports include closures such as duck bill valves for
engagement by proboscises of an oral chamber when attached to the
nasal chamber.
[0120] The present invention also provides a disposable CPAP system
comprising a nasal mask as above described, and a removable oral
mask.
[0121] Shown in FIG. 25 is a configuration for a combined
disposable continuous positive airway pressure (CPAP) system and
manual resuscitation system. The configuration consists of the
following: a nasal chamber or nasal mask 1010 which has two ports,
a circuit port 1012 and an exhaust port 1014 and one or more
attachment ports 1016 which may include duck bill valves, a peep
valve adaptor 1018, which connects to a positive end of an
expiratory pressure (PEEP) valve 1020 and has a supplemental oxygen
port 1022, which connects to supplemental oxygen source through
tubing 1024. The circuit port 1012 attaches to adaptor 1018, which
then attaches to the positive end expiratory pressure (PEEP) valve
1020 and applies a range of back-pressures to help stent open an
obstructed airway and keep alveoli open, acting as a source for
continuous positive airway pressure (CPAP). The exhaust port 1014
within the nasal mask 1020 is open to atmosphere and functions to
prevent suffocation. Since the exhaust port 1014 is open to
atmosphere a patient can inhale and exhale through it. It also
prevents re-breathing of carbon dioxide (CO.sub.2). This
configuration can also be used as a manual resuscitation device
intermittently covering the exhaust port, 1014, allowing pressure
to be built up within the device and then uncovering the exhaust
port and allowing for exhalation.
[0122] The duck bill valves within ports 116 of the nasal mask 1010
have three functions. Their first function is as an inhalation
valve to allow the patient to inhale without much resistance. Their
second function is to seal shut upon exhalation, which prevents
excessive leaking and maintains positive pressure. Their third
function is to permit attachment of different accessories. For
example, as shown in FIG. 26, an oral chamber 1021 can be attached
to the duck bill valves 1016. Within the oral chamber 1026 are
proboscises (not shown) and when they are inserted into the duck
bill valves 1016, the duck bill valves open i.e. as described in
our aforesaid '934, '277 and '341 PCT Applications. This allows for
bilateral flow through the nose and mouth, and converts the
disposable nasal CPAP to a disposable full facemask CPAP.
[0123] The PEEP valve adaptor 1018 has two functions. The first
function is that it has a supplemental oxygen port 1022 within it.
The supplemental oxygen port is for connection to a supplemental
oxygen source via supplemental oxygen tubing. This is what supplies
oxygen (i.e.: gas flow) to the nasal mask and allows pressure to be
built up within the mask. The second function of the adaptor is to
connect to the PEEP valve 1020. The PEEP valve 1020 is the
resistance that the patient has to exhale against. The PEEP valve
820 is adjustable from, e.g., 0 cmH.sub.2O-30 cmH.sub.2O.
[0124] Shown in FIG. 26 is a disposable CPAP system in accordance
with the present invention is converted to a full facemask CPAP
system. The oral chamber 1026 has two proboscises within in it.
When the oral chamber's proboscises are inserted into the nasal
chamber's duck bill valves 1016, the duck bill valves 1016 open up
and allow for bilateral flow through the nose and mouth of the
patient, thus converting from a nasal CPAP mask to a full facemask
CPAP. The advantage is that is allows for the pressure within the
mask to be maintained without removing and replacing the mask with
a full face mask
[0125] Various changes may be made without departing from the
spirit and the scope of the present invention. By way of example,
while the nasal mask portion of the combination nasal/oral mask as
described in our '973, '277 and '341 PCT applications and as
commercially available as the SuperNO.sub.2VA mask as described
above, and including attachment ports duckbill valves is
particularly useful for accepting accessories and attachments,
other valves may be incorporated into the nasal mask. Also, it is
not necessary that the attachment ports include valves which
automatically close. In fact, simple removable plugs or frangible
membranes could be employed in place of valves. Thus, any nasal
mask having one or more sealable ports located over the upper lips
of a patient may be advantageously adapted to support various
attachments and accessories as above described. Also, in the case
of end tidal CO.sub.2 measurement, an exhalation scoop may be fixed
directly or formed integrally with a lower portion conventional
nasal mask, i.e., to lie adjacent the upper lip of a patient. Still
other changes would be possible without departing from the spirit
and scope of the invention.
* * * * *