U.S. patent application number 13/053785 was filed with the patent office on 2012-05-17 for nasal airway management device.
This patent application is currently assigned to The Johns Hopkins University. Invention is credited to Viachaslau M. Barodka.
Application Number | 20120118286 13/053785 |
Document ID | / |
Family ID | 46046651 |
Filed Date | 2012-05-17 |
United States Patent
Application |
20120118286 |
Kind Code |
A1 |
Barodka; Viachaslau M. |
May 17, 2012 |
NASAL AIRWAY MANAGEMENT DEVICE
Abstract
An airway management device including a hollow flexible tube.
The tube defines a lumen extending between a proximal end and a
distal end. The proximal end is configured to be coupled to a
ventilator and/or anesthesia circuit. An opening is provided at or
near the distal end to allow passage of air and/or anesthesia
therethrough. The tube is configured to be expanded radially after
insertion through a patient's nasopharyngeal passageway when the
distal end of the tube is positioned proximate the patient's
hypopharynx. The device may include an inflatable outer sleeve
surrounding and extending along the length of the tube. When the
outer sleeve is in a deflated state, the distal end of the tube may
be inserted through a patient's nasopharyngeal passageway. When the
distal end of the tube is positioned proximate the patient's
hypopharynx, the outer sleeve may be inflated and expanded. The
device may include an inflatable cuff attached at or near the
distal end of the tube and including an opening fluidly coupled
with the opening and lumen of the tube to allow passage of air
and/or anesthesia therethrough. When in a deflated state, the
inflatable cuff may be inserted through the patient's
nasopharyngeal passageway. When in an inflated state, the
inflatable cuff may expand to form a seal around the patient's
supraglottic laryngeal inlet. An intermediate inflatable cuff
having a larger diameter than other portions of the outer sleeve
when inflated may be positioned along the length of the tube
between the proximal and distal ends. The respective inflatable
elements of the device may be concurrently or separately
inflatable.
Inventors: |
Barodka; Viachaslau M.;
(Baltimore, MD) |
Assignee: |
The Johns Hopkins
University
Baltimore
MD
|
Family ID: |
46046651 |
Appl. No.: |
13/053785 |
Filed: |
March 22, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61412943 |
Nov 12, 2010 |
|
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|
Current U.S.
Class: |
128/203.12 ;
128/207.18 |
Current CPC
Class: |
A61M 16/0461 20130101;
A61M 16/0409 20140204; A61M 16/0445 20140204; A61M 2016/0027
20130101; A61M 16/0443 20140204; A61M 16/0486 20140204; A61M
16/0488 20130101; A61M 16/0459 20140204; A61M 16/0434 20130101 |
Class at
Publication: |
128/203.12 ;
128/207.18 |
International
Class: |
A61M 16/01 20060101
A61M016/01; A61M 16/00 20060101 A61M016/00 |
Claims
1. An airway management device, comprising: a hollow flexible tube
defining a lumen extending between a proximal end and a distal end,
wherein the proximal end is configured to be coupled to at least
one of a ventilator and an anesthesia circuit, wherein an opening
is provided proximate the distal end to allow passage of air and/or
anesthesia therethrough, and wherein the tube is configured to be
expanded radially after insertion through a patient's
nasopharyngeal passageway when the distal end of the tube is
positioned proximate the patient's hypopharynx.
2. The airway management device according to claim 1, further
comprising: an inflatable outer sleeve surrounding and extending
along a length of the tube, wherein, when the outer sleeve is in a
deflated state, the distal end of the tube is configured to be
inserted through a patient's nasopharyngeal passageway, and
wherein, when the distal end of the tube is positioned proximate
the patient's hypopharynx, the outer sleeve is configured to be
inflated and expanded.
3. The airway management device according to claim 2, further
comprising: an inflatable cuff attached at or near the distal end
of the tube, wherein the inflatable cuff defines an opening fluidly
coupled with the opening and lumen of the tube to allow passage of
air and/or anesthesia therethrough, wherein, when in a deflated
state, the inflatable cuff is configured to be inserted through the
patient's nasopharyngeal passageway, and wherein, when in an
inflated state, the inflatable cuff is configured to expand to form
a seal around the patient's supraglottic laryngeal inlet.
4. The airway management device according to claim 3, wherein a
space between an outer surface of the tube and an inner surface of
the outer sleeve defines an inflation passage extending along the
tube and fluidly coupled to the inflatable cuff to allow concurrent
inflation and deflation of the outer sleeve and the inflatable
cuff.
5. The airway management device according to claim 5, wherein the
outer sleeve further comprises an intermediate inflatable cuff
portion disposed between the proximal and distal ends, wherein the
intermediate inflatable cuff portion is configured to have a larger
diameter than other portions of the outer sleeve when inflated, and
wherein, when positioned in the patient's oropharynx and inflated,
the intermediate inflatable cuff portion of the outer sleeve is
configured to secure the tube therein and prevent the tube from
sliding back into the nasopharyngeal passageway.
6. The airway management device according to claim 3, further
comprising a pilot tube extending along the length of the tube.
8. The airway management device according to claim 6, wherein the
pilot tube is fluidly coupled to the inflatable cuff and to a space
between an outer surface of the tube and an inner surface of the
outer sleeve to allow concurrent inflation and deflation of the
inflatable cuff and the outer sleeve.
9. The airway management device according to claim 8, further
comprising an intermediate inflatable cuff provided on the outer
sleeve between the proximal and distal ends, wherein the
intermediate inflatable cuff is configured to have a larger
diameter than the outer sleeve when inflated, and wherein, when
positioned in the patient's oropharynx and inflated, the
intermediate inflatable cuff is configured to secure the tube
therein and prevent the tube from sliding back into the
nasopharyngeal passageway.
10. The airway management device according to claim 9, wherein the
intermediate inflatable cuff is fluidly coupled to at least one of
the pilot tube and a space between the outer surface of the tube
and the inner surface of the outer sleeve to allow concurrent
inflation and deflation of the outer sleeve, the inflatable cuff,
and the intermediate inflatable cuff.
11. The airway management device according to claim 9, wherein the
intermediate inflatable cuff is fluidly coupled to a second pilot
tube to allow inflation and deflation of the intermediate
inflatable cuff separate from the outer sleeve and the inflatable
cuff.
12. The airway management device according to claim 6, wherein the
pilot tube is fluidly coupled to the inflatable cuff to allow
inflation and deflation of the inflatable cuff separate from the
outer sleeve.
13. The airway management device according to claim 12, further
comprising an intermediate inflatable cuff provided on the outer
sleeve between the proximal and distal ends, wherein the
intermediate inflatable cuff is configured to have a larger
diameter than the outer sleeve when inflated, and wherein, when
positioned in the patient's oropharynx and inflated, the
intermediate inflatable cuff is configured to secure the tube
therein and prevent the tube from sliding back into the
nasopharyngeal passageway.
14. The airway management device according to claim 13, wherein the
intermediate inflatable cuff is fluidly coupled to a space between
the outer surface of the tube and the inner surface of the outer
sleeve to allow concurrent inflation and deflation of the outer
sleeve and the intermediate inflatable cuff.
15. The airway management device according to claim 13, wherein the
intermediate inflatable cuff is fluidly coupled to at least one of
the pilot tube and the inflatable cuff to allow concurrent
inflation and deflation of the inflatable cuff and the intermediate
inflatable cuff.
16. The airway management device according to claim 13, wherein the
intermediate inflatable cuff is fluidly coupled to a second pilot
tube to allow inflation and deflation of the intermediate
inflatable cuff separate from the outer sleeve and the inflatable
cuff.
17. The airway management device according to claim 2, further
comprising an intermediate inflatable cuff provided on the outer
sleeve between the proximal and distal ends, wherein the
intermediate inflatable cuff is configured to have a larger
diameter than the outer sleeve when inflated, and wherein, when
positioned in the patient's oropharynx and inflated, the
intermediate inflatable cuff is configured to secure the tube
therein and prevent the tube from sliding back into the
nasopharyngeal passageway.
18. The airway management device according to claim 17, wherein a
space between an outer surface of the tube and an inner surface of
the outer sleeve defines an inflation passage extending along the
tube and fluidly coupled to the intermediate inflatable cuff to
allow concurrent inflation and deflation of the outer sleeve and
the intermediate inflatable cuff.
19. The airway management device according to claim 17, further
comprising a pilot tube extending along the length of the tube.
20. The airway management device according to claim 19, wherein the
intermediate inflatable cuff is fluidly coupled to the pilot tube
to allow inflation and deflation of the intermediate inflatable
cuff separate from the outer sleeve.
21. The airway management device according to claim 1, further
comprising a plurality of pilot tubes extending along a length of
the tube and configured to radially expand the tube when
inflated.
22. The airway management device according to claim 21, wherein the
pilot tubes spiral along the length of the tube, wherein, when the
pilot tubes are inflated, the length of the tube increases.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application No. 61/412,943 filed Nov. 12, 2010, the entire contents
of which are hereby incorporated by reference.
BACKGROUND
[0002] 1. Field of Invention
[0003] The invention relates generally to airway management devices
and, more particularly, to a nasal airway management device with an
inflatable outer sleeve.
[0004] 2. Discussion of Related Art
[0005] Maintaining and securing a patient's airway and providing
adequate ventilation when necessary are core principles to ensure
oxygen delivery in all human beings. Controlling a patient's airway
is the first and most important principle in basic life support and
advanced cardiac life support algorithms. Humans cannot survive the
interruption of oxygen delivery to the body for more than 5-10
minutes. This puts enormous pressure on ensuring timely and
reliable means of airway control in emergency situations.
Anesthetized patients, sedated patients, critically ill patients
and coding patients, for example, often can not maintain an airway
or adequately breath on their own and almost always require
assisted ventilation. Accordingly, airway devices are typically
placed in a patient's airway by trained professionals in order to
assist with ventilation or to maintain and protect the airway.
These devices may include, for example, oral and nasal airways,
laryngeal mask airways (LMAs), and endotracheal tubes. These
devices, however, have several disadvantages. For example, highly
trained healthcare personnel and special instrumentation are
typically required for the placement of advanced airway devices
such as LMAs and endotracheal tubes. Moreover, sedation or general
anesthesia are required during placement and use of LMAs and
endotracheal tubes. Other devices such as, for example, nasal and
oral airways and external face masks, while less invasive,
nevertheless provide limited or no ability to provide assisted
ventilation.
[0006] There is a need for quick, simple and reliable airway
management device to provide airway control and assisted
ventilation in, for example but not limited to, emergency
situations.
SUMMARY
[0007] In an embodiment of the invention, an airway management
device is provided. The airway management device according to an
embodiment of the invention includes a hollow flexible tube. The
tube defines a lumen extending between a proximal end and a distal
end. The proximal end may be coupled to at least one of a
ventilator and an anesthesia circuit. An opening is provided
proximate the distal end of the tube to allow passage of air and/or
anesthesia therethrough. The tube may be expanded radially after
insertion through a patient's nasopharyngeal passageway when the
distal end of the tube is positioned proximate the patient's
hypopharynx.
[0008] According to an embodiment of the invention, the airway
management device may also include an inflatable outer sleeve
surrounding and extending along the length of the tube. When the
outer sleeve is in a deflated state, the distal end of the tube may
be inserted through a patient's nasopharyngeal passageway. When the
distal end of the tube is positioned proximate the patient's
hypopharynx, the outer sleeve may be inflated and expanded.
[0009] According to another embodiment, an inflatable cuff may be
attached at or near the distal end of the tube. The inflatable cuff
may define an opening fluidly coupled with the opening and lumen of
the tube to allow passage of air and/or anesthesia therethrough.
When in a deflated state, the inflatable cuff may be inserted
through the patient's nasopharyngeal passageway. When in an
inflated state, the inflatable cuff may expand to form a seal
around the patient's supraglottic laryngeal inlet.
[0010] According to another embodiment, the device may include an
intermediate inflatable cuff positioned along the length of the
tube between the proximal and distal ends and having a larger
diameter than other portions of the outer sleeve when inflated.
[0011] According to another embodiment, the respective inflatable
elements of the device may be concurrently or separately
inflatable.
[0012] Further features and advantages, as well as the structure
and operation of various embodiments of the invention, are
described in detail below with reference to the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The foregoing and other features and advantages of the
invention will be apparent from the following, more particular
description of some example embodiments of the invention, as
illustrated in the accompanying drawings. Unless otherwise
indicated, the accompanying drawing figures are not to scale.
Several embodiments of the invention will be described with respect
to the following drawings, in which like reference numerals
represent like features throughout the figures, and in which:
[0014] FIG. 1 depicts a perspective view of a nasal airway
management device having an inflatable outer sleeve and an
inflatable supraglottic laryngeal cuff, both in a deflated state,
according to an embodiment of the invention;
[0015] FIG. 2 depicts a perspective view of the nasal airway
management device of FIG. 1 with both the outer sleeve and
supraglottic laryngeal cuff in an inflated state according to an
embodiment of the invention;
[0016] FIG. 3 depicts the nasal airway management device of FIG. 1
in a deflated state in a patient's laryngopharynx after insertion
through the nasopharyngeal passageway;
[0017] FIG. 4 depicts the nasal airway management device of FIG. 3
in the patient's laryngopharynx after insertion through the
nasopharyngeal passageway and inflation of the outer sleeve and
supraglottic laryngeal cuff;
[0018] FIG. 5 depicts a perspective view of a nasal airway
management device having an inflatable outer sleeve, an inflatable
intermediate cuff, and an inflatable supraglottic laryngeal cuff,
all in a deflated state, according to an embodiment of the
invention;
[0019] FIG. 6 depicts a perspective view of the nasal airway
management device of FIG. 5 with the outer sleeve, intermediate
cuff, and supraglottic laryngeal cuff all in an inflated state
according to an embodiment of the invention;
[0020] FIG. 7 depicts the nasal airway management device of FIG. 5
in a deflated state in a patient's laryngopharynx after insertion
through the nasopharyngeal passageway;
[0021] FIG. 8 depicts the nasal airway management device of FIG. 6
in the patient's laryngopharynx after insertion through the
nasopharyngeal passageway and inflation of the outer sleeve, the
intermediate cuff, and the supraglottic laryngeal cuff;
[0022] FIG. 9 depicts a perspective view of a nasal airway
management device having an inflatable outer sleeve in an inflated
state according to an embodiment of the invention;
[0023] FIG. 10 depicts a perspective view of a nasal airway
management device having an inflatable outer sleeve and an
inflatable intermediate cuff, both in an inflated state, according
to an embodiment of the invention; and
[0024] FIGS. 11A-H and 12 depict a cross-sectional view of the
nasal airway management device of any of FIGS. 1-10 according to
another embodiment of the invention, including at least one pilot
tube to provide for separate inflation of one or more of the
respective inflatable elements.
[0025] FIGS. 13-14 depict a schematic cross-sectional view of the
tube according to an embodiment of the invention having multiple
pilot tubes extending along the length thereof to expand the lumen
of the tube when inflated.
DETAILED DESCRIPTION
[0026] Some embodiments of the invention are discussed in detail
below. In describing embodiments, specific terminology is employed
for the sake of clarity. However, the invention is not intended to
be limited to the specific terminology so selected. A person
skilled in the relevant art will recognize that other equivalent
components can be employed and other methods developed without
departing from the broad concepts of the invention. All references
cited herein are incorporated by reference as if each had been
individually incorporated.
[0027] FIGS. 1 and 2 depict perspective views of a nasal airway
management device 10 according to an embodiment of the invention.
The device 10 includes a hollow flexible tube 12 defining a lumen
extending between a proximal end 18 and a distal end 20. An
inflatable outer sleeve 14 may surround and extend along the length
of the tube 12. An inflatable supraglottic laryngeal cuff 16 may be
attached at or near the distal end 20 of the tube 12. Both outer
sleeve 14 and cuff 16 are shown in a deflated state in FIG. 1. In
FIG. 2, both the outer sleeve 14 and cuff 16 are shown in an
inflated state. The proximal end 18 of the tube 12 may include a
connector portion 22 and an inflation port 23. The connector
portion 22 may be configured to be coupled to a ventilator, a
ventilation bag, or an anesthetic circuit (not shown). The
inflation port 23 may be configured to be coupled to an automatic
or manual inflation mechanism such as, for example, a syringe
filled with air or another suitable gas or liquid substance for
inflation and deflation of one or both of the outer sleeve 14 and
cuff 16. Additional inflation ports are possible to provide for
separate inflation/deflation of respective inflatable elements. An
adjustable annular flange 24 may be moveably disposed on an outer
periphery of the tube 12 near the proximal end 18 to help stabilize
and hold the tube 12 in place at the patient's nostril N.
[0028] The tube 12, particularly the distal end 20, is configured
for insertion through a patient's nostril N and nasopharyngeal
passageway NP to a position in the laryngopharynx (or hypopharynx)
LP (see FIG. 3). The tube 12 may be formed from a variety of
suitable materials such as, for example but not limited to,
polyvinylchloride (PVC), although other materials are possible so
long as they are body tolerated and constructed to provide enough
rigidity to prevent collapse, twisting, kinking and/or buckling of
the tube in the nasal cavity and in the pharynx. The tube 12 should
also be flexible enough to avoid causing nasal trauma during
insertion and use. As discussed in further details below, the tube
12 is configured to be expanded radially after insertion through
the patient's nasopharyngeal passageway NP when the distal end 20
of the tube 12 is positioned proximate the patient's hypopharynx LP
so as to allow easier passage of air, anesthesia, or a combination
thereof.
[0029] In some embodiments, the inflatable cuff 16 is attached at
or near the distal end 20 of the tube 12 and may be arranged to be
inflated and deflated via an inflation passage defined by a space
between the inner surface of the outer sleeve 14 and the outer
surface of the tube 12. The inflation passage may extend along the
tube 12 and may be fluidly coupled to the inflatable cuff 16 to
allow concurrent inflation and deflation of the outer sleeve 14 and
the cuff 16. In some embodiments, discussed further below, a pilot
tube 140 (see FIGS. 11A-11H and 12) may extend along the tube 12 to
provide for concurrent or separate radial expansion of the tube 12,
inflation of the cuff 16, and/or inflation of the outer sleeve
14.
[0030] The outer sleeve 14 and inflatable cuff 16 may include thin,
flexible and compliant material such as, for example, PVC or
polyurethane, although other materials are possible. When in a
deflated state such as, for example, as shown in the embodiment
depicted in FIG. 1, the outer sleeve 14 and inflatable cuff 16 are
sized and configured to be inserted through the patient's
nasopharyngeal passageway NP (see FIG. 3). For example, the outer
sleeve 14 and inflatable cuff 16 may be densely packed about the
tube 12 so as to facilitate insertion via the patient's nostril N
and nasopharyngeal passageway NP. In an embodiment, the densely
packed inflatable cuff 16 may form a substantially conical shape
extending from the distal end 20 of the tube 12. The deflated cuff
16 may define, for example, a round, smooth elongated tip with a
gradually increasing diameter to facilitate atraumatic insertion of
the device 10. The inflatable cuff 16 defines an opening 26 fluidly
coupled with the lumen of the tube 12 to allow passage of air or
other gaseous substance. In an embodiment not shown in greater
detail herein, the inflatable cuff 16 may comprise an outer portion
and an inner portion. The outer portion may be formed from a
relatively thick and semi-rigid material such as, for example, of
the same thickness and rigidity as the tube 12. The inner portion
may be of a relatively thinner and more flexible material densely
packed inside the outer portion about the distal end 20 of the tube
12 when the inflatable cuff 16 is in the deflated state to
facilitate insertion of the distal end 20 of the tube 12 through
the patient's nasopharyngeal passageway NP. Once inflated, the
outer portion unfolds and forms a semi-rigid base wider than the
diameter of the tube 12 against posterior wall of the
laryngopharynx forming a base and structural support for the inner
portion of the cuff 16. The inflated inner portion the cuff 16
expands on the edges of the semi-rigid outer portion and forms a
final shape to provide a seal of the supraglottic laryngeal
inlet.
[0031] FIG. 3 depicts a side cross-sectional view of a patient's
head with after insertion of the device 10 through the nostril N
and nasopharyngeal passageway NP. The outer sleeve 14 and
inflatable cuff 16 are shown positioned in the patient's
oronasopharynx OP and laryngopharynx LP, respectively, in a
deflated state. FIG. 4 depicts the distal end 20 of the tube 12 of
the nasal airway management device 10 in the patient's
laryngopharynx LP after inflation of the outer sleeve 14 and cuff
16. When inflated, for example, the outer sleeve 14 may be
expanded. Similarly, when in the inflated state, the inflatable
cuff 16 is expanded to a shape and size configured to form a seal
around the patient's supraglottic laryngeal inlet L. For example,
the inflated cuff 16 may form a substantially elliptical or oval
structure circumscribing the opening 26 and disposed at an angle to
a longitudinal axis of the tube 12. In this regard, the cuff 16 can
function as a nasally-inserted supraglottic laryngeal mask,
allowing ventilation of the patient while the patient's oral cavity
O remains free of any airway devices. The inflatable cuff 16 seals
the larynx and trachea T from the esophagus E and pharynx and
allows a healthcare provider to deliver PPV (positive pressure
ventilation), CPAP (continuous positive airway pressure) or PEEP
(positive end expiratory pressure) to the patient via the device
10. Thus, once inflated, the cuff 16 may be in the form of, for
example, a triangular pyramid occupying the laryngopharynx LP, the
space between the glottic opening and choana (i.e., the anatomical
opening of the nasal airway passage in the nasopharynx). Inflation
of the cuff 16 lifts the epiglottis away from the glottic opening
to prevent it from obstructing the airway (see FIG. 4).
Alternatively, when the inflatable cuff 16 is positioned in the
patient's laryngopharynx LP in the deflated state (FIG. 3), the
device 10 may serve to simply maintain patency of the patient's
airway and allow spontaneous ventilation via the opening 26.
[0032] As shown in the embodiment depicted in FIGS. 1-4, the tube
12 may include a curved shaped such as, for example, a U-shape to
mimic nasal airway anatomy and add a second dimension to allow only
one position for insertion. Other positioning structures and/or
indicator markings are, however, possible to ensure correct
positioning of the cuff 16 adjacent to the supraglottic laryngeal
inlet L. The device 10 may be offered in different sizes to fit
different patients. Before placement, the outer sleeve 14 and cuff
16 should be in the deflated state. Lubrication jelly, possibly
including local anesthetic, may be applied to the outer sleeve 14
and cuff 16 and along the outer wall of the tube 12 from the distal
end 20 to assist with gentle insertion through the patient's
nostril N and nasopharyngeal passageway NP. Local anesthetic spray
may also be applied to the patient's nostril N. Once inserted, the
outer sleeve 14 and cuff 16 may be inflated concurrently via the
inflation port 23 (or separately via respective inflation ports)
by, for example, a 10-20 cc syringe filled with air or another
suitable gas or liquid substance. The inflated cuff 16 will make
the form of a laryngeal mask providing the seal between larynx and
the rest of pharynx and esophagus E. Inflation of the cuff 16 may
protect the vocal cords and airway and allow the delivery of PPV,
CPAP or PEEP assisted ventilation.
[0033] When PPV, CPAP, or PEEP is no longer needed, or if the
patient should undergo unassisted spontaneous breathing trials such
that simple maintenance the patency of the airway remains, the
device 10 can be left in place with cuff 16 deflated and outer
sleeve 14 either deflated or still inflated (if separately
inflatable). In this case, the device 10 can serve as a
conventional nasal airway. Nasal airways provide minimal
stimulation to the patient and are extremely well tolerated
compared to endotracheal tubes or LMAs. In addition the patient
would be able to talk. At any time, the cuff 16 could be inflated
again if there is a need to resume assisted ventilation.
[0034] FIGS. 5 and 6 depict perspective views of a nasal airway
management device 100 according to another embodiment of the
invention and having a tube 112, an outer inflatable sleeve 114, an
inflatable cuff 116 and an inflatable intermediate positioning cuff
130. The outer sleeve 114, cuff 116, and intermediate cuff 130 are
all shown in a deflated state in FIG. 5. In FIG. 6, the outer
sleeve 114, cuff 116, and intermediate cuff 130 are all shown in an
inflated state. Airway management device 100 is substantially the
same as device 10, described above, except that device 100 includes
the second intermediate inflatable cuff 130 at a position along the
tube 112 between the proximal and distal ends 118, 120,
respectively. The intermediate inflatable cuff 130 may be
configured to be inflated in order to fix and hold the airway tube
112 in position patient's nasopharyngeal passageway NP. When the
device 100 is inserted with the outer sleeve 114 and cuffs 116, 130
all in the deflated state, the intermediate cuff 130 should be
positioned along the tube 112 on outer sleeve 114 so that it
corresponds to the oronasoparynx (see FIGS. 7 and 8). Once
inflated, as shown in FIG. 8, the device 100 may be gently pulled
back such that the intermediate cuff 130 will be positioned in the
oronasopharynx OP and will prevent dislodgement of the tube 112
back out of the nostril N. The intermediate inflatable cuff 130 may
be part of the outer sleeve 114 or coupled thereto and may have a
larger diameter than other portions of the outer sleeve 114 when
inflated. The intermediate cuff 130 may be fluidly coupled to one
or both of the outer sleeve 114 and cuff 116 to allow concurrent
inflation therewith. Alternatively, the intermediate cuff 130 may
be separately inflated via a pilot tube as further discussed
below.
[0035] FIG. 9 depicts a perspective view of a nasal airway
management device 200 according to another embodiment of the
invention and having a tube 212 and an outer inflatable sleeve 214.
The outer sleeve 214 is shown in an inflated state in FIG. 9.
Airway management device 200 is substantially the same as devices
10 and 100, described above, without an inflatable cuff at the
distal end 220 of the tube 212 or an intermediate inflatable cuff
at a position along the tube 212 between the proximal and distal
ends 218, 220. When inflated after insertion through a patient's
nostril N, for example, the outer sleeve 214 may be expanded with
the distal end 220 of the tube 212 positioned proximate the
laryngopharynx LP. FIG. 10 depicts a perspective view of a nasal
airway management device 300 according to another embodiment of the
invention and having a tube 312, an outer inflatable sleeve 314,
and an intermediate inflatable cuff 330 at a position along the
tube 312 between the proximal and distal ends 318, 320. The outer
sleeve 314 and intermediate inflatable cuff 330 are shown in an
inflated state in FIG. 10. Airway management device 300 is
substantially the same as devices 10, 100, and 200, described
above, without an inflatable cuff at the distal end 320 of the tube
312. When inflated after insertion through a patient's nostril N,
for example, the outer sleeve 314 may be expanded with the distal
end 320 of the tube 312 positioned proximate the laryngopharynx LP.
The intermediate cuff 330 may be fluidly coupled to the outer
sleeve 314 to allow concurrent inflation and deflation therewith.
Alternatively, the intermediate cuff 330 may be separately inflated
and deflated via a pilot tube as further discussed below.
[0036] FIGS. 11A-11H and 12 depict cross-sectional views of the
nasal airway management device as shown in any of FIGS. 1-10
according to several embodiments of the invention and which
optionally allows for separate inflation and deflation of the
respective inflatable members of the device. For simplicity,
reference is made hereafter to the embodiment of the device 100
depicted in FIGS. 5-8. As shown in FIG. 11A, for example, a pilot
tube 140 may be provided extending along the length of the tube 112
to allow for separate inflation of one or more of the respective
inflatable elements such as, for example, outer sleeve 114,
inflatable cuff 116, and intermediate inflatable cuff 130 (not
shown in FIGS. 11A-11H). As shown in FIGS. 11A, 11C, and 11D, the
pilot tube 140 may be coupled to or formed integral with the tube
112. As shown in FIG. 11B, the pilot tube 140 may be disposed
within the lumen of the tube 112 and extend freely along the length
of the tube 112. As shown in FIGS. 11F, 11G, and 11H, the pilot
tube 140 may be coupled to or formed integral with the outer sleeve
114. As shown in FIG. 11E, the pilot tube 140 may extend freely
along the length of the tube 112 in a space between an outer
surface of the tube 112 and an inner surface of the outer sleeve
114. As shown in FIG. 12, multiple pilot tubes 140', 140'' may be
provided along the length of the tube 112.
[0037] As shown in the embodiment depicted in FIGS. 13-14, the tube
112 may be provided without an outer sleeve, and may be expanded
radially (e.g., increasing internal diameter) when the pilot tubes
140, 140', 140'' extending along the length thereof are inflated.
The pilot tubes 140, 140', 140'' may also spiral (not shown in
detail) along the length of the tube 112 such that when the pilot
tubes 140, 140', 140'' are inflated, the length of the tube 112
increases.
[0038] The embodiments of the nasal airway management device may be
useful and beneficial in various medical situations. For example,
the device may be utilized for rescue ventilation in emergency
situations to provide effective and reliable ventilation by nurses
or other non-anesthesia trained personnel involved in the
management of a coding patient before arrival of anesthesia or
emergency rooms doctors and placement of an endotracheal tube.
Additionally, the device may be utilized in the early postoperative
period to prevent a patient's tongue and soft tissue from
collapsing onto the pharynx and obstructing the patient's upper
airway while also providing the ability to rapidly transition to
PPV by inflating the cuff when a patient stops breathing due to
over-sedation, muscle weakness or residual anesthetic effects.
[0039] The device may also be utilized in outpatient procedures
requiring sedation. These procedures (e.g. colonoscopies,
endoscopies, transesophageal echocardiograms) are done under
anesthesia sedation with intravenous general anesthetics (e.g.
propofol) or combination of narcotic with anxiolitic. One of the
anesthetic goals of such a technique is to keep patients breathing
on their own (spontaneous ventilation) while supplemental oxygen is
provided via nasal cannula. Emergency situations arise when a
patient is over-sedated and stops breathing. Effective use of the
device in place of conventional nasal cannulas will dramatically
improve safety, by allowing timely, effective and smooth transition
to PPV in a case of anesthetic overdose and cessation of
spontaneous ventilation. Similar use under general anesthesia may
be provided.
[0040] While various embodiments of the present invention have been
described above, it should be understood that they have been
presented by way of example only, and not limitation. Thus, the
breadth and scope of the present invention should not be limited by
any of the above-described embodiments, but should instead be
defined only in accordance with the following claims and their
equivalents.
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