U.S. patent application number 15/206624 was filed with the patent office on 2016-11-03 for medical device, and the methods of using same.
The applicant listed for this patent is WM & DG, Inc.. Invention is credited to Robert Molnar.
Application Number | 20160317769 15/206624 |
Document ID | / |
Family ID | 51687244 |
Filed Date | 2016-11-03 |
United States Patent
Application |
20160317769 |
Kind Code |
A1 |
Molnar; Robert |
November 3, 2016 |
MEDICAL DEVICE, AND THE METHODS OF USING SAME
Abstract
A medical device is provided for insertion into a cavity of a
patient to visual the internal membranes of the patient. The
medical device can be an endotracheal tube, a suction tube, a
bronchoscope, a tube changer, an esophageal tube, an intubating
tube, an esophageal tube in combination with a separate intubating
tube, a device for manipulating the position of the epiglottis of
the patient, a stylet, or a tube insertable into the vagina of the
patient. The medical device has a camera lumen having a sealed
window at one end thereof attached thereto, and a separate camera
which is insertable into the camera lumen and is removable from the
camera lumen. The camera is used to monitor the internal membranes
of the patient during the medical procedure.
Inventors: |
Molnar; Robert; (Long Grove,
IL) |
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Applicant: |
Name |
City |
State |
Country |
Type |
WM & DG, Inc. |
Deerfield |
IL |
US |
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|
Family ID: |
51687244 |
Appl. No.: |
15/206624 |
Filed: |
July 11, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13947610 |
Jul 22, 2013 |
9415179 |
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15206624 |
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13486549 |
Jun 1, 2012 |
9357905 |
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13947610 |
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61674924 |
Jul 24, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/05 20130101; A61B
1/267 20130101; A61M 16/0463 20130101; A61M 16/04 20130101; A61B
1/00154 20130101; A61B 1/015 20130101; A61B 1/00128 20130101; A61M
16/042 20140204; A61M 16/0409 20140204; A61M 2205/3375 20130101;
A61M 2205/502 20130101; A61M 2230/04 20130101; A61M 25/0169
20130101; A61M 2025/0681 20130101; A61M 16/0434 20130101; A61B
1/303 20130101; A61B 1/0684 20130101; A61B 5/435 20130101; A61B
1/0676 20130101; A61M 16/0488 20130101; A61B 1/2676 20130101; A61B
1/04 20130101; A61B 7/003 20130101 |
International
Class: |
A61M 16/04 20060101
A61M016/04; A61B 1/04 20060101 A61B001/04; A61B 1/015 20060101
A61B001/015; A61B 5/00 20060101 A61B005/00; A61M 25/01 20060101
A61M025/01; A61B 1/303 20060101 A61B001/303; A61B 7/00 20060101
A61B007/00; A61B 1/06 20060101 A61B001/06; A61B 1/00 20060101
A61B001/00; A61B 1/267 20060101 A61B001/267 |
Claims
1. An assembly comprising: a medical device for insertion into a
cavity of a patient, said medical device comprising: a wall having
a proximal end and a distal end, and a passageway extending between
said proximal and distal ends; a camera lumen having a sealed
window at one end thereof said camera lumen attached to said wall
of said medical device, and said sealed window being proximate to
said distal end of said wall; and a separate camera insertable into
said camera lumen, said camera being removable from said camera
lumen.
2-7. (canceled)
8. The assembly of claim 1, wherein said medical device is a
suction tube for use in suctioning the cavity of the patient; said
distal end of said wall having a series of perforations
therethrough.
9. The assembly of claim 8, wherein said suction tube is curved
along its length.
10. The assembly of claim 9, further including a connector provided
at said proximal end of said suction tube, said connector having
two ports.
11. The assembly of claim 1, wherein said medical device is a
bronchoscope for use in intubating the patient.
12. The assembly of claim 1, wherein said medical device is a tube
changer used for changing one endotracheal tube for another
endotracheal tube, said wall of said tube changer having graduation
marks thereon.
13. The assembly of claim 12, further including a connector
attached to said proximal end of said wall, said connector being
capable of being connected to a ventilator.
14. The assembly of claim 12, wherein said camera lumen is slidably
connected to said tube changer.
15. The assembly of claim 1, wherein said medical device is a tube
insertable into the vagina of a patient.
16. The assembly of claim 1, wherein said medical device comprises
an esophageal tube for use in monitoring breath sounds of the
patient, said esophageal tube formed of said wall, and a separate
intubating tube connected to said esophageal tube, said intubating
tube for use in intubating the patient using an endotracheal tube,
said intubating tube formed of a wall having a passageway
therethrough.
17. The assembly of claim 16, wherein said wall of esophageal tube
has first and second arcuate portions connected to each other by
curved end portions, said wall of esophageal tube having an open
proximal end providing a proximal inlet opening, said wall of
esophageal tube having a generally conical end portion having an
aperture therethrough provided at a distal end of said wall, said
passageway of esophageal tube extending through said wall of
esophageal tube and through the conical end portion, said aperture
being in communication with said passageway of esophageal tube.
18. The assembly of claim 16, wherein said esophageal tube is
curved along its length, and said intubating tube is curved along
its length.
19. The assembly of claim 16, further including a slot through said
wall of said intubating tube which is in fluid communication with
said passageway of said intubating tube, said slot extending from a
proximal end to a distal end of said wall of said intubating tube,
said slot in said intubating tube is opposite to the point of
connection of said intubating tube to said esophageal tube.
20. (canceled)
21. A medical device for insertion into a cavity of a patient for
use in determining the status of the internal membranes of the
patient comprising: an intubating tube for use in intubating the
patient using an endotracheal tube, said intubating tube formed of
a body having a proximal end and a distal end, an elongated recess
formed in said body having a proximal end, a distal end and a
length, said recess generally extending from said proximal end of
said body to said distal end of said body; a sleeve connected to
said intubating tube, said sleeve being C-shaped such that an
elongated slot is formed, said sleeve being rotatable relative to
said intubating tube, said sleeve having a length which is less
than the length of the recess; a camera lumen having a sealed
window at one end thereof, said camera lumen attached to said
intubating tube, said sealed window being positioned proximate to
said distal end of said recess; a separate camera insertable into
said camera lumen, said camera being removable from said camera
lumen.
22. The medical device of claim 21, further including an
endotracheal tube inserted within said recess.
23. The medical device of claim 21, wherein said body has a
generally conical tip at said distal end, said tip having a weight
therein.
24. The medical device of claim 21, wherein said recess is curved
along its length such that in cross-section said recess is
generally arcuate and forms a proximal curved ramp surface.
25. A medical device for insertion into a mouth of a patient for
manipulating the position of the epiglottis of the patient for
intubation, said medical device comprising: a handle having
proximal and distal ends; a curved body extending from an end of
said handle; a finger grip handle extending from said handle at an
angle thereto and at said proximal end of said body, said finger
grip handle capable of being flexed relative to said handle; a tip
provided at said distal end of said body, said tip capable of being
flexed relative to said body; a camera lumen having a sealed window
at one end thereof said camera lumen attached to said body, said
sealed window being positioned proximate to said body; and a
separate camera insertable into said camera lumen, said camera
being removable from said camera lumen.
26. The medical device of claim 25, further including a disposable
sleeve conforming to said tip and said body, said sleeve formed of
a thin plastic material, said sleeve having apertures
therethrough.
27. A medical device for insertion into a cavity of a patient
comprising: a stylet having a proximal end and a distal end; a
camera lumen having a sealed window at one end thereof said camera
lumen attached to said stylet, said sealed window being positioned
proximate to said distal end of said stylet; and a separate camera
insertable into said camera lumen, said camera being removable from
said camera lumen.
Description
[0001] This application is a continuation-in-part application of
U.S. Ser. No. 13/486,549, filed on Jun. 1, 2012, the disclosure of
which is incorporated in its entirety. This application claims the
domestic benefit of U.S. Ser. No. 61/674,924, filed on Jul. 24,
2012, the disclosure of which is incorporated in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to a medical device for
allowing a medical professional to see the internal membranes of a
patient during a medical procedure.
BACKGROUND OF THE INVENTION
[0003] An example of a medical device which medical professionals
use to see the internal membranes of a patient is a laryngeal mask
airway. A laryngeal mask airway is used to ventilate and to supply
anesthetic to a patient during surgery. A laryngeal mask airway is
different than an endotracheal tube in that the laryngeal mask
airway is positioned in the throat of the patient proximally of the
vocal folds, while an endotracheal tube is passed through the vocal
folds and is positioned in the patient's trachea.
[0004] Laryngeal mask airways of the prior art generally have a
tube opening into the center of a generally elliptical dome. The
tube is generally straight, but can flex to assume a curved shape.
A cuff, which may be inflatable, is sometimes attached to the
perimeter of the dome.
[0005] In use, the medical professional inserts the laryngeal mask
airway into the mouth of the patient. The open tube allows the
patient to breathe on his/her own during insertion. The tube can
also be connected to a ventilator to provide assisted breathing to
the patient. For insertion, the cuff (if provided), the dome and
the tube slide against the hard palate and then against the soft
palate and into the pharynx of the patient. This procedure is
performed blindly and only by feel which comes from experience in
performing the procedure. Trauma to the patient may occur when
placing the laryngeal mask airway as a result of the laryngeal mask
airway attempting to conform to a curved position in the pharynx.
When properly positioned in the hypo-pharynx, the proximal end of
the cuff seats against the epiglottis pushing it toward the tongue
of the patient and the distal end of the cuff seats in the
esophagus. At times, the cuff may be positioned such that the
epiglottis is pushed downwardly and may at least partially block
the tube opening. This is not a desirable result as the blocking by
the epiglottis can cause problems with the airflow through the
laryngeal mask airway. In addition, inappropriate sizing and
differences in the anatomy of patients may also impair the proper
positioning of the laryngeal mask airway. Since the insertion is
performed blindly, the medical professional will not know if proper
placement of the laryngeal mask airway has occurred. After
positioning the laryngeal mask airway, the inflatable cuff (if
provided) is inflated and the patient's esophagus is blocked by the
cuff. The medical professional will listen for breath sounds and
ascertain end tidal CO.sub.2 gases from the patient to verify
proper positioning of the laryngeal mask airway.
[0006] If the medical professional needs to insert an endotracheal
tube into the patient, the endotracheal tube can be inserted
through the tube of the laryngeal mask airway to intubate the
patient. If the epiglottis is at least partially blocking the
opening in the tube, this intubation may be difficult. In addition,
the glottis opening quite often does not align with the tube
opening which can make this blind insertion difficult and may
result in trauma to the laryngeal inlet.
[0007] A medical device is provided herein which provides
improvements to existing laryngeal mask airways and which overcomes
the disadvantages presented by the prior art. Other features and
advantages will become apparent upon a reading of the attached
specification, in combination with a study of the drawings.
SUMMARY OF THE INVENTION
[0008] A medical device is provided for insertion into a cavity of
a patient to visual the internal membranes of the patient. The
medical device can be an endotracheal tube, a suction tube, a
bronchoscope, a tube changer, an esophageal tube, an intubating
tube, an esophageal tube in combination with a separate intubating
tube, a device for manipulating the position of the epiglottis of
the patient, a stylet, or a tube insertable into the vagina of the
patient. The medical device has a camera lumen having a sealed
window at one end thereof attached thereto, and a separate camera
which is insertable into the camera lumen and is removable from the
camera lumen. The camera is used to monitor the internal membranes
of the patient during the medical procedure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The organization and manner of the structure and operation
of the invention, together with further objects and advantages
thereof, may best be understood by reference to the following
description, taken in connection with the accompanying drawings,
wherein like reference numerals identify like elements in
which:
[0010] FIG. 1 is a perspective view of a medical device which
incorporates the features of the present invention, the medical
device being inserted into a patient, and shown with an
endotracheal tube and a ventilator which are capable of being used
with the medical device;
[0011] FIG. 2 is a perspective view of the medical device of FIG.
1;
[0012] FIG. 3 is an alternate perspective view of the medical
device of FIG. 1;
[0013] FIG. 4 is yet another alternate perspective view of the
medical device of FIG. 1;
[0014] FIG. 5 is a side elevation view of the medical device of
FIG. 1;
[0015] FIG. 6 is a side elevation view of the medical device of
FIG. 1 inserted into a patient;
[0016] FIG. 7 is a side elevation view of the medical device of
FIG. 1 inserted into a patient, and shown with an endotracheal tube
inserted therein;
[0017] FIG. 8 is a schematic view of the medical device of FIG.
1;
[0018] FIG. 9 is a perspective view of an alternate medical device
which incorporates the features of the present invention;
[0019] FIG. 9A is a perspective view of a modification to the
medical device of FIG. 9;
[0020] FIG. 10 is a schematic view of the medical device of FIG.
9;
[0021] FIG. 11 is a schematic of a control system for use with the
medical devices shown in the drawings;
[0022] FIG. 12 is a perspective view of an airway assist device
which incorporates the features of the present invention for use
with the medical devices of FIGS. 1 and 9 and 10;
[0023] FIG. 13 is a side elevation view of the airway assist device
of FIG. 12;
[0024] FIG. 14 is a perspective view of the lumens which form part
of the airway assist device of FIG. 12;
[0025] FIGS. 15 and 16 are side elevation views of the airway
assist device of FIG. 12 inserted into a patient;
[0026] FIG. 17 is a perspective view of an alternate airway assist
device which incorporates the features of the present invention for
use with the medical devices of FIGS. 1 and 9/10;
[0027] FIG. 18 is a perspective view of the airway assist device of
FIG. 17 with a medical device mounted therein;
[0028] FIGS. 19 and 20 are side elevation views of the airway
assist device of FIG. 17 with a medical device mounted therein;
[0029] FIG. 21 is a perspective view of another medical device
which incorporates the features of the present invention inserted
into a patient;
[0030] FIG. 22 is a side elevation view of the medical device of
FIG. 21;
[0031] FIG. 23 is an end elevation view of the medical device of
FIG. 21;
[0032] FIG. 24 is alternate perspective view of the medical device
of FIG. 21:
[0033] FIGS. 25A-25E are side elevation views of the medical device
of FIG. 21 being inserted into a patient, and being used with a
stylet and an endotracheal tube;
[0034] FIGS. 26 and 27 are perspective views of an alternate
medical device which incorporates the features of the present
invention;
[0035] FIG. 28 is a side elevation view of the medical device of
FIGS. 26 and 27;
[0036] FIGS. 29 and 30 are perspective views of the medical device
of FIGS. 26-28, with an endotracheal tube being shown for use
therewith;
[0037] FIGS. 31A and 31B are side elevation views of the medical
device of FIGS. 26-28 being inserted into a patient, and being used
with an endotracheal tube;
[0038] FIG. 32 is a perspective view of another medical device
which incorporates the features of the present invention;
[0039] FIG. 33 is a perspective view of yet another medical device
which incorporates the features of the present invention;
[0040] FIG. 34 is a perspective view of the medical device of FIG.
33 in an alternate position;
[0041] FIG. 35 is a cross-sectional view of the medical device of
FIG. 33;
[0042] FIG. 36 is a perspective view of another medical device
which incorporates the features of the present invention;
[0043] FIGS. 37A and 37B show the medical device of FIG. 36 in use
in a patient;
[0044] FIGS. 38-39C show perspective views of a further medical
device which incorporates the features of the present
invention;
[0045] FIG. 40 shows a perspective view of yet another medical
device which incorporates the features of the present
invention:
[0046] FIG. 41 shows a perspective view of yet another medical
device which incorporates the features of the present
invention;
[0047] FIG. 42 shows a perspective view of another medical device
which incorporates the features of the present invention;
[0048] FIGS. 43 and 44 show perspective views of yet a further
medical device which incorporates the features of the present
invention:
[0049] FIG. 45 shows a perspective view of another medical device
which incorporates the features of the present invention; and
[0050] FIG. 46 shows a perspective view of a tool which can be used
with the medical device of FIG. 45.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0051] While the invention may be susceptible to embodiment in
different forms, there is shown in the drawings, and herein will be
described in detail, a specific embodiment with the understanding
that the present disclosure is to be considered an exemplification
of the principles of the invention, and is not intended to limit
the invention to that as illustrated and described herein.
Therefore, unless otherwise noted, features disclosed herein may be
combined together to form additional combinations that were not
otherwise shown for purposes of brevity.
[0052] FIGS. 1-8 show a first embodiment of a medical device 20 and
FIGS. 9/9A and 10 show a second embodiment of a medical device 120.
The medical device 20, 120 is inserted into the throat of a patient
22 to open the airway to allow the patient 22 to breathe on his/her
own, to allow the patient 22 to breathe with ventilation via a
ventilator 23 or for intubating the patient 22 with an endotracheal
tube 24. Each medical device 20, 120 is formed of a dual-tube
design which includes a ventilating tube 26, 126 and an intubating
tube 28, 128 which are connected to a dome 30, 130. A cuff 32, 132,
which may inflatable, is attached to the perimeter 31, 131 of the
dome 30, 130. While the inflatable cuff 32, 132 is shown and
described herein, the inflatable cuff 32, 132 is not necessary, or
it may be formed of rubber provided at the end of the tubes 26,
126, 28, 128. The dual-tube design provides the ventilating tube
26, 126 for allowing the patient to breathe on his/her own or for
ventilation, and the intubating tube 28, 128 for intubation of the
patient 22.
[0053] Each medical device 20, 120 includes a camera lumen 58 which
is formed by a small diameter flexible plastic tube. The camera
lumen 58 has a proximal end and an opposite distal end and a
central passageway therethrough. The distal end of the camera lumen
58 has a clear window 60 which is sealed to the camera lumen 58 to
close the end of the central passageway. As a result, the camera
lumen 58/window 60 are impervious to gases/fluids such that entry
of fluids and other matter into the camera lumen 58 is prevented. A
pair of LED lights 62 may be formed in the wall of the camera lumen
58 on opposite sides of the window 60. If LED lights 62 are
provided in the camera lumen, wires are molded into the camera
lumen 58 and extend from the proximal end thereof for connection to
a suitable power source. A non-disposable camera 66 can be easily
slid into and removed from the scaled camera lumen 58/window 60
combination. Instead of providing separate LED lights 62 in the
camera lumen 58, the camera 66 and LED lights 62 (or other source
of lighting, including a camera with its own built-in lighting) can
be incorporated into a single non-disposable device which is
insertable and removeable from the camera lumen 58.
[0054] Each medical device 20, 120 includes a transmission lumen 68
for transmitting breath and heartbeat sounds from the patient 22 to
the medical professional. The transmission lumen 68 is formed by a
small-diameter flexible plastic tube having a central passageway
and a series of perforations 70 at its distal end. The perforations
70 are covered by a thin gauge plastic cap 72. When the medical
device 20, 120 is seated in the throat of the patient 22, the
distal end of the transmission lumen 68 is positioned closest to
the esophagus 80 which enables breath and heartbeat sounds to be
easily transmitted through the perforations 70 and along the length
of the transmission lumen 68 to the medical professional monitoring
the patient 22.
[0055] Attention is invited to the first embodiment of the medical
device 20 shown in FIGS. 1-8 which shows the specifics of the
dual-tube design. [0006] Each tube 26, 28 is formed from a
cylindrical wall 36, 38 having a proximal open inlet 36a, 38a (at
the end closest to the medical professional), an opposite distal
open outlet 36b, 38b (at the end furthest away from the medical
professional during use of the medical device 20) and a central
passageway 36c, 38c extending through the respective tube 36, 38.
Each tube 36, 38 has a centerline 36d, 38d which extends from the
proximal inlet 36a, 38a to the distal outlet 36b, 38b. The tubes
26, 28 are curved along the length of each tube 26, 28 and the
centerlines 36d, 38d are accordingly curved. Each tube 26, 28 has a
diameter which is preferably 15 mm, however, each tube 26, 28 may
be bigger or smaller, and/or not of equal diameter with respect to
each other. Each tube 26, 28 is formed of a relatively stiff but
compliant plastics material and is preferably formed by extrusion.
The tubes 26, 28 are situated side-by-side and thus the centerlines
36d, 38d of the tubes 26, 28 are parallel to each other. The inlets
36a, 38a generally align with each other, and the outlets 36b, 38b
generally align with each other. Proximate to the distal outlets
36b, 38b of the tubes 26, 28, the inner portions of the walls 36,
38 merge together at the dome 30.
[0056] The dome 30 is formed of a plastics material like that of
the tubes 26, 28. The dome 30 has a ramped surface 40 proximate to
the intubating tube 28 which acts as a ramp for the insertion of
the endotracheal tube 24 into the throat of the patient 22. The
perimeter 31 of the dome 30 distal from the distal ends of the
tubes 26, 28 generally forms an ellipse.
[0057] The centerlines 36d, 38d of the tubes 26, 28 generally fall
along the major axis 31f of the ellipse and are offset from each
other, with one centerline 36d proximate to one focus 31a of the
ellipse and the other centerline 38d proximate to the other focus
31 b of the ellipse. As schematically shown in FIG. 8, the distal
open outlet 36b of the ventilating tube 26 generally aligns with
focus 31a and forms a ventilating passageway. The distal open
outlet 38c of the intubating tube 28 generally aligns with focus 31
b. The ramped surface 40 is between distal open outlet 38c of the
intubating tube 28 and the vertex 31d of the ellipse. The inner
portions of the walls 36, 38 preferably generally align with the
center 31c of the ellipse. The intubating tube 28 and the ramped
surface 40 form an intubating passageway along their lengths. While
the distal open outlet 38c of the intubating tube 28 is described
and shown as generally aligning with focus 31 b, it is to be
understood that the ramped surface 40 can be positioned to
generally align with this focus 31 b.
[0058] The inflatable cuff 32, if provided, surrounds the perimeter
31 of the dome 30. A central opening 42 is formed by the cuff 32.
The inner edge of the cuff 32 is bonded or otherwise suitably
secured, such as by ultrasonic welding, to the perimeter 31 of the
dome 30. Thus the inner edge of the cuff 32 is generally
elliptical. The cuff 32 is preferably formed of a thin, flexible
plastics material so that the cuff 32 can be deflated to a low
profile for insertion into the patient 22 and can be inflated to
seal with the surrounding tissue when the medical device 20 is
correctly positioned in the throat of the patient 22 as described
herein.
[0059] The medical device 20 includes an inflation line 44 which is
formed by a small diameter flexible plastic tube. As shown, the
inflation line 44 is provided proximate to the ventilating tube 26
at a position farthest from the intubating tube 28. This position
is only illustrative and the inflation line 44 can be provided at
other locations. The distal end of the inflatable cuff 32 is scaled
with the outside of the inflation line 44 so that it opens into the
interior of the inflatable cuff 32. The proximal end of the
inflation line 44 is attached to a combined inflation indicator
balloon and connector 46 which are known in the art. The inflation
line 44 can be attached to one of the tubes 26, 28 along its
length, if desired. Alternatively, an extruded small-bore lumen
(not shown) can be provided within the wall 36, 28 of one of the
tubes 26, 28 to provide the inflation line 44.
[0060] A cap 48 is provided at the proximal end of the intubating
tube 28 for sealing the proximal outlet 38a of the intubating tube
28 when it is not in use. Preferably, the cap 48 is formed of
rubber. The cap 48 can have a flip-top, or can be removed from the
intubating tube 28, to allow access to the intubating passageway
when needed. Other means for sealing the end of the intubating tube
28, while selectively allowing access to the intubating passageway
therein, are within the scope of the present invention.
[0061] The camera lumen 58 has a distal end which is preferably
provided at the vertex 31e of the ellipse between the ventilating
tube 26 and the cuff 32. The ventilating tube 26 and the cuff 32
are sealed to the camera lumen 58 by suitable means. Instead of a
separate lumen attached to the ventilating tube 26 and the cuff 32,
an extruded small-bore lumen can be provided within the wall of the
ventilating tube 26, with the window 60 sealed to the end thereof.
The camera 66 is preferably provided at the vertex 31 e of the
ellipse between the ventilating tube 26 and the cuff 32 as this
provides the best angle for viewing the tissues of the patient 22
when the medical device 20 is being inserted. It is to be
understood that the camera 66 can be placed in other positions.
[0062] The transmission lumen 68 seats against the intubating tube
28 and the distal end of the transmission lumen 68 is attached to
the cuff 32 or is attached near the distal outlet 38b of the
ventilating tube 26 near the cuff 32, such that the end of the
transmission lumen 68 is positioned proximate to the ramped surface
40. When the medical device 20 is seated in the throat of the
patient 22, the distal end of the transmission lumen 68 is
positioned closest to the esophagus 80 which enables breath and
heartbeat sounds to be easily transmitted through the perforations
70 and along the length of the transmission lumen 68 to the medical
professional monitoring the patient 22.
[0063] In use, the medical professional inserts the medical device
20 through the mouth and into the throat of the patient 22. The
intubating tube 28 is closed by the cap 48 at its proximal outlet
38a and is not used. The ventilating tube 26 remains open to allow
the patient 22 to breathe on his/her own through the ventilating
tube 26 through the open proximal inlet 36a of the ventilating tube
26. The ventilating tube 26 can also be connected to the ventilator
23 to provide assisted breathing to the patient 22. The cuff 32 and
the intubating tube 28 slide against the hard palate and then
against the soft palate and into the pharynx of the patient 22. The
medical device 20 will flex to assume a curved shape to conform to
the throat of the patient 22. The medical professional uses the
camera 66 to properly guide the medical device 20 into the pharynx.
Because the camera 66 provides constant visualization of the
tissues during insertion of the medical device 20 into the patient,
the medical professional can be assured that the medical device 20
is being properly inserted and positioned in the throat of the
patient 22 with limited trauma to the patient 22. The medical
professional can see the vocal folds via the camera 66 to ensure
proper positioning of the medical device 20 in the patient's
throat. Once positioned in the pharynx, one end 73 of the cuff 32
seats against the epiglottis 74 pushing it toward the tongue 76 of
the patient 22 and the opposite end 78 of the cuff 32 seats in the
esophagus 80. The cuff 32 is then inflated. As a result, the
esophagus 80 is blocked by the cuff 32 and the epiglottis 74 is
moved out of the way of the ventilating and intubating passageways
36c, 38c. The distal outlets 36b, 38b of the ventilating and
intubating passageways 36c. 38c are open to the glottis of the
patient 22. During this entire procedure of insertion, the camera
66 provides constant visualization of the tissues during insertion
of the medical device 20 into the patient 22. The patient 22 can
breathe by airflow through the open ventilating tube 26. Since the
camera 66 is constantly operating during insertion and through the
entire medical procedure, the medical professional can constantly
visually confirm that the patient 22 is breathing. The constant
visualization of the laryngeal inlet and the vocal folds of the
patient 22 can make earlier diagnoses of issues, for example, but
not limited to, secretions, tumors, paralyzed vocal folds, apnea,
bleeding, and abnormal anatomy, as well as other potentially
harmful effects to the patient 22.
[0064] If the medical professional needs to insert an endotracheal
tube 24 into the patient 22, the cap 48 on the intubating tube 28
is removed/opened and the endotracheal tube 24 is inserted through
the proximal outlet 38a of the intubating tube 28 and through the
passageway 36c of the intubating tube 28. The endotracheal tube 24
will contact the ramped surface 40 which properly directs the
endotracheal tube 24 into the pharynx. Once the endotracheal tube
24 exits the intubating tube 28 at its distal outlet 38b, the
medical professional can see the positioning of the endotracheal
tube 24 via the camera 66. The medical professional can thus guide
the endotracheal tube 24 through the vocal folds and into the
trachea, and inflate the cuff of the endotracheal tube 24, under
the constant visualization provided by the camera 66. At times, the
medical device 20 may be advanced, pulled back, or turned from side
to side, to maintain the proper trajectory through the vocal folds.
This is easily accomplished since there is constant visualization
of the tissues via the camera 66. In addition, known moveable
stylets (not shown) may be used. The ventilator 23 is then
disconnected from the ventilating tube 26 and the ventilating tube
26 is capped, or the ventilator 23 remains connected, but turned
off.
[0065] As a result of the structure of the medical device 20, the
intubating tube 28 is located furthest away from the epiglottis 74
when the medical device 20 is positioned within the patient 22.
This minimizes the ability of the epiglottis 74 to block the
insertion of the endotracheal tube 24 into the trachea in the event
that the epiglottis 74 is not seated between the cuff 32 and the
tongue 76.
[0066] Attention is now invited to the second embodiment of the
medical device 120 shown in FIGS. 9 and 10 which shows the
specifics of the dual-tube design.
[0067] Each tube 126, 128 is formed from a cylindrical wall 136,
138 having a proximal open inlet 136a, 138a (at the ends closest to
the medical professional), an opposite open distal outlet 136b,
138b (at the ends furthest away from the medical professional
during use of the medical device 120) and a central passageway
136c, 138c extending through the respective tube 126, 128. Tube 128
is shown in full line in FIG. 9 to illustrate the construction of
the tube 128 (of course, in practice, tube 126 may be opaque such
that tube 128 would not be visible along its length). The outlets
136b, 138b generally align with each other. Each tube 126, 128 has
a centerline 136d, 138d which extends from the proximal inlet 136a,
138a to the distal outlet 1366, 138b. The tubes 126, 128 are curved
along the lengths thereof and the centerlines 136d, 138d are
accordingly curved. Each tube 126, 128 is formed of a relatively
stiff but compliant plastics material and is preferably formed by
extrusion. Tube 126 forms the ventilating tube, however, tube 128
is also used in the ventilating process as described herein. Tube
128 forms the intubating tube.
[0068] The intubating tube 128 is positioned within the ventilating
tube 126. A portion of the wall 136 of the ventilating tube 126 is
preferably connected to the intubating tube 128, as shown in FIG.
9, along a junction 150 to affix the tubes 126, 128 together and to
prevent the intubating tube 128 from moving around within the
ventilating tube 126. The centerlines of the tubes 126, 128 are
parallel to each other. The ventilating tube 216 has a diameter
which is preferably 20 mm, and the intubating tube 128 has a
diameter which is preferably 10 mm.
[0069] The intubating tube 128 has an elongated slit 152 along its
length opposite to the junction 150 to allow for gas communication
between the passageway 136c of the ventilating tube 126 and the
passageway 138c of the intubating tube 128. The slit 152 can extend
the entire length of the intubating tube 128 as shown, or can
extend along a portion of the length of the intubating tube
128.
[0070] The ventilating tube 126 has a ventilating port 154 in its
wall 136 proximate to, but spaced from, the proximal open inlet
136a thereof. The ventilating port 154 is preferably proximate to
the slit 152 in the intubating tube 128. A connector tube 156 is
formed around the ventilating port 154. The connector tube 156 may
be integrally formed with the ventilating tube 126, or may be a
separate component which is sealed to the ventilating tube 126 by
known means.
[0071] The dome 130 is formed of a plastics material like that of
the tubes 126, 128. The dome 130 is formed at the distal outlet
136b of the ventilating tube 126. The dome 130 has a ramped surface
140 which connects to the intubating tube 128 to act as a ramp for
the insertion of the endotracheal tube 24 into the throat of the
patient 22 as described herein. The perimeter 131 of the dome 30
distal from the distal ends of the tubes 126, 128 generally forms
an ellipse.
[0072] The inflatable cuff 132 surrounds the perimeter 131 of the
dome 130. A central opening 142 is formed by the cuff 132. The
inner edge of the cuff 132 is bonded or otherwise suitably secured,
such as by ultrasonic welding, to the perimeter 131 of the dome
130. Thus the inner edge of the cuff 32 is generally elliptical.
The cuff 132 is preferably formed of a thin, flexible plastics
material so that the cuff 132 can be deflated to a low profile for
insertion into the patient's throat and can be inflated once
properly positioned to seal with the surrounding tissue when the
medical device 120 is correctly positioned in the throat of the
patient 22 as described herein.
[0073] The centerlines 136d, 138d of the tubes 126, 128 generally
fall along the major axis 31f of the ellipse and are offset from
each other. As schematically shown in FIG. 10, the distal open
outlet 136b of the ventilating tube 126 generally aligns with both
foci 31 a, 31 b as this ventilating tube 126 is large. The distal
open outlet 138c of the intubating tube 128 generally aligns with
one focus 31b. The ramped surface 140 is between distal open outlet
136c of the ventilating tube 128 and the vertex 31d of the ellipse.
The intubating tube 128 and the ramped surface 140 form an
intubating passageway.
[0074] The medical device 120 includes an inflation line like that
of the first embodiment (not shown in FIG. 8) and therefore, the
specifics are not repeated herein. Like elements are denoted by
like reference numerals with the elements of the second embodiment
being denoted with reference numerals in the one-hundreds.
[0075] A cap 148 attaches to the proximal inlet 136a of the
ventilating tube 126 to prevent access to the open proximal outlet
138a of the intubating tube 128 when the endotracheal tube 24 is
not being used. Preferably, the cap 148 is formed of rubber. The
cap 148 can have a flip-top as shown to allow access to the
intubating passageway 138c, or can be removed from the ventilating
tube 126 to allow access to the intubating passageway 138c. Other
means for sealing the end of the ventilating tube 126, while
selectively allowing access to the intubating passageway 138c, are
within the scope of the present invention.
[0076] The transmission lumen 68 seats against the ventilating tube
126 and the distal end of the transmission lumen 68 is either
attached to the cuff 132 or is attached near the distal outlet 138b
of the ventilating tube 126 near the cuff 132. When the medical
device 120 is seated in the throat of the patient 22, the distal
end of the transmission lumen 68 is positioned closest to the
esophagus 80 which enables breath and heartbeat sounds to be easily
transmitted through the perforations 170 and along the length of
the transmission lumen 68 to the medical professional monitoring
the patient 22.
[0077] The distal end of the camera lumen 58 is preferably provided
at the vertex 31e of the ellipse between the ventilating tube 126
and the cuff 132 which are sealed thereto. Alternatively, an
extruded small-bore lumen can be provided within the wall of the
ventilating tube 126, with the window 60 sealed to the end thereof.
The camera 66 is preferably provided at the vertex 31 e of the
ellipse between the ventilating tube 126 and the cuff 132 as this
provides the best angle for viewing the tissues of the patient 22
when the medical device 120 is being inserted. It is to be
understood that the camera 66 and camera lumen 58 can be placed in
other positions.
[0078] In use, the medical professional inserts the medical device
120 through the mouth and into the throat of the patient 22. The
open ventilating tube 126 allows the patient 22 to breathe on
his/her own through the connector 156 attached to the ventilating
tube 126. The ventilating tube 126 can also be connected to the
ventilator 23 to provide assisted breathing to the patient 22. The
cuff 132 and the ventilating tube 126 slide against the hard palate
and then against the soft palate and into the pharynx of the
patient 22. The medical device 120 will flex to assume a curved
shape to conform to the throat of the patient 22. The medical
professional uses the camera 66 to properly guide the medical
device 120 into the pharynx. Because the camera 66 provides
constant visualization of the tissues during insertion and the
entire time that the medical device 120 is in the patient 22, the
medical professional can be assured that the medical device 120 is
being properly inserted and maintained. The medical professional
can see the vocal folds via the camera 66 to ensure proper
positioning of the medical device 120 in the patient's throat.
Since the camera 66 is constantly operating, the medical
professional can constantly visually confirm movement of the vocal
folds to be assured that the patient 22 is breathing. Once
positioned in the pharynx, the proximal end of the cuff 132 seats
against the epiglottis 74 pushing it toward the tongue 76 of the
patient 22 and the distal end of the cuff 132 seats in the
esophagus 80. The cuff 132 is then inflated. As a result, the
esophagus 80 is blocked by the cuff 132 and the epiglottis 74 is
moved out of the way of the ventilating and intubating passageways
136c, 138c. The distal outlets 136b, 138b of the intubating tube
126 and the ventilating tube 128 are open to the glottis of the
patient 22. During this entire procedure, the camera 66 provides
constant visualization of the tissues during insertion of the
medical device 120 into the patient 22 and continues throughout the
entire medical procedure. The constant visualization of the
laryngeal inlet and the vocal folds of the patient 22 can make
earlier diagnoses of issues, for example, but not limited to,
secretions, tumors, paralyzed vocal folds, apnea, bleeding, and
abnormal anatomy, as well as other potentially harmful effects to
the patient 22.
[0079] The patient can breathe by airflow through the connector
56/ventilating tube 126. Air can also flow through the slit 152 and
through the intubating tube 128 to the patient 22.
[0080] If the medical professional needs to insert an endotracheal
tube 24 into the patient 22, the cap 148 is removed/opened (opened
via removing the plug 148a on the cap 148 to open the passageway
148b in the cap 148) to allow access to the proximal outlet 138a of
the intubating tube 128 and the endotracheal tube 24 is inserted
through the proximal outlet 138a and through the intubating
passageway 138c. The endotracheal tube 24 will contact the ramped
surface 140 which properly directs the endotracheal tube 24 into
the pharynx. Once the endotracheal tube 24 exits the intubating
tube 28, the medical professional can see the positioning of the
endotracheal tube 24 via the camera 66. The medical professional
can thus guide the endotracheal tube 24 through the vocal folds and
into the trachea, and then inflate the cuff of the endotracheal
tube 24, under the constant visualization provided by the camera
66. At times, the medical device 120 may be advanced, pulled back,
or turned from side to side, to maintain the proper trajectory
through the vocal folds. In addition, known moveable stylets (not
shown) may be used. The ventilator 23 is then disconnected from the
ventilating tube 26 and the connector 156 may be capped (although
it can be left open since the endotracheal tube 24 is in place), or
the ventilator 23 can remain connected, but turned off.
[0081] In this embodiment of the medical device 120, the
ventilating port 154 and connector tube 156 can be moved from the
tube 126 to a modified cap 148' as shown in FIG. 9A (like that=of
FIG. 9, tube 128 is shown in full line in FIG. 9A to illustrate the
construction of the tube 128 (of course, in practice, tube 126 may
be opaque such that tube 128 would not be visible along its
length)). This modified cap 148' allows for ventilation (via
ventilation port 56/connector tube 154), intubation (intubation is
achieved by removing the plug 148a on the cap 148' to open the
passageway 148b in the cap 148'), and connection to the tube 128.
The skirt 148c of the cap 148 is longer than the skirt of the cap
148 to accommodate the ventilation port 156, while still allowing
the cap 148' to be connected to the tube 128.
[0082] The intubating tube 128 is located furthest away from the
epiglottis 74 when the medical device 120 is inserted. This
minimizes the ability of the epiglottis 74 to block the insertion
of the endotracheal tube 24 into the trachea of the patient 22 in
the event that the epiglottis 74 is not seated between the cuff 132
and the tongue 76.
[0083] The dual tubes 26/126, 281128 thus provide the ability for a
patient 22 to breathe on his/her own, to breathe under ventilation
via the ventilator 23, or to be intubated using the endotracheal
tube 24. The endotracheal tube 24 can be removed from the
intubating tube 28, 128 and the intubating tube 28, 128 capped, and
the patient 22 can return to breathing on his/her own or under
ventilation through the ventilating tube 26, 126 without removal of
the medical device 20, 120 from the patient 22. If the patient 22
becomes distressed or if circumstances dictate, the endotracheal
tube 24 can be reinserted into the intubating tube 28, 128. This
provides great flexibility for the medical professional to keep the
patient's airway open, to constantly visually verify that the
patient's airway is open during the entire medical procedure, and
to constantly verify by hearing that the patient's airway is open
during the entire procedure.
[0084] The transmission lumen 68 is positioned proximate to the
esophagus 80 which is the location closest to the lungs and heart
of the patient 22. This enables breath and heart sounds to be
easily transmitted along the transmission lumen 68.
[0085] The medical device 20, 120 is intended to be in the patient
22 during the entire medical procedure. The video information from
the camera 66 and the information from the transmission lumen 68
are transmitted to a microprocessor 82, FIG. 11, via appropriate
means, such as wires, wireless, Bluetooth, etc., which in turn can
transmit the information to another computer, mobile devices, a
mobile station and the like, via appropriate means, such as wires,
wireless, Bluetooth, etc., and then this information can be
accessed by appropriate personnel. This microprocessor 82 can be
on-site where the procedure is being performed or can be remote
from the procedure site. For example, the information can be
supplied to the nurses' station and the nurse on duty will be able
to instantly know if the patient 22 is breathing by the visual
confirmation that the vocal folds are opening and closing and by
hearing breath and heart sounds. The medical professional will be
able to interpret the depth of anesthesia by looking at the
rhythmic movement of the vocal folds as well as other diagnoses
previously mentioned. Other medical personnel can be hundreds of
miles away and still be able to monitor, advise, confirm, and
diagnose without the patient 22 being in close physical proximity
to that medical personnel. Since the camera 66 is constantly
operating, medical personnel can tell at any time if the patient 22
is properly ventilated/intubated and is breathing.
[0086] If desired, the medical device 20, 120 can be removed once
the endotracheal tube 24 is properly positioned because the
intubating passageway 38c, 138c is sufficiently large to slide over
the endotracheal tube 24 without dislodging the endotracheal tube
24 from the patient's throat.
[0087] A temperature sensor (not shown) can also be incorporated
into the medical device 20, 120 for providing temperature
information to the appropriate personnel via the microprocessor
82.
[0088] The medical device 20, 120 is disposable. Since the camera
66 is removed from the medical device 20, 120 before disposal, an
expensive component of the medical device 20, 120 is reusable.
While the lights 62 are described as being provided in the medical
device 20, 120, it is possible for the lights 62 to be built into
the camera 66.
[0089] FIGS. 12-16 show a first embodiment of an airway assist
device 84 and FIGS. 17-20 show a second embodiment of an airway
assist device 184, each of which are used in combination with the
medical device 20, 120. The airway assist device 84, 184 can be
used to manipulate the position of the patient's epiglottis 74 and
tongue 76 to further ensure that the epiglottis 74 and tongue 76
are moved out of the way of the ventilating and intubating
passageways 36c, 136c, 38c, 138c and to minimize the chance of
blockage of the passageways 36c. 136c, 38c, 138c by the epiglottis
74. These airway assist devices 84, 184 allow first responders, for
example, paramedics, an easier way to provide patency to the airway
of the patient 22, and to easily advance the medical device 20, 120
under constant visualization by the camera 66.
[0090] Attention is invited to the airway assist device 84 shown in
FIGS. 12-16. The airway assist device 84 is formed from an airway
holder 86 and a tongue positioner 96.
[0091] The airway holder 86 is formed of a cylindrical tube which
has a central passageway 86c extending from a proximal end 86a
thereof to a distal end 86b thereof. The central passageway 86c has
a large enough diameter to allow the medical device 20, 120 to pass
therethrough. The airway holder 86 is preferably curved in the same
shape as the medical devices 20, 120.
[0092] An elongated mounting extension 88 extends from the airway
holder 86. The mounting extension 88 has a dovetail opening 90
extending along the length thereof. Alternatively, the wall of the
airway holder 86 could be thickened and the dovetail opening 90
formed therein. A collar 92 is provided at the proximal end 86a of
the airway holder 86 and extends perpendicularly therefrom.
[0093] The airway assist device 84 includes a camera lumen 58 for
housing a camera 66 and a transmission lumen 68 attached to the
outer surface of the airway holder 86 at a position which is
diametrically opposed to the mounting extension 88. The camera
lumen 58, the camera 66 and the transmission lumen 68 are identical
to those shown in the medical devices 20, 120 and the specifics are
therefore not repeated. A lumen 94 for housing a temperature sensor
is also provided (such a lumen 94 and temperature can be provided
with the medical devices 20, 120). As shown, the lumens 58, 68, 94
are positioned side-by-side and attached to the airway holder 86 by
suitable means. The lumens 58, 68, 94 can be integrally formed with
the airway holder 86.
[0094] The tongue positioner 96 is slidably received in the
mounting extension 88. The tongue positioner 96 has an elongated
body 98 which is curved and has a distal end 100 which has a radius
which is substantially greater than the radius at which the body 98
is curved. The edge 102 of the distal end 100 is preferably
arcuate. A handle 104 is provided at the proximal end of the body
98 which enables a medical professional to grasp the tongue
positioner 96. The tongue positioner 96 is preferably formed of a
rigid plastic. The distal end 100 may be covered with a soft
material, such as silicone. A dovetail protrusion 1 06 extends
outwardly from the body 98 and seats within the dovetail slot 90 in
the mounting extension 88.
[0095] A series of spaced apart ratchet teeth 108 extend outwardly
from the body 98 proximate to the handle 104. The teeth 108 are
capable of engaging with the collar 92 to hold the position of the
tongue positioner 96 proximally and distally relative to the airway
holder 86.
[0096] In use, the medical professional inserts the airway assist
device 84 into the mouth of the patient 22. The airway holder
86/lumens 58, 68, 94 28 slide against the hard palate and then
against the soft palate and partially into the pharynx of the
patient 22 until the distal end 1 00 of the airway assist device 84
enters into the vallecula 11 0 and the edge 102 engages the tissues
of the patient 22. The tongue positioner 96 may slide along the
patient's tongue 76. The camera 66 on the airway assist device 84
allows the medical professional to see the tissues and determine
the proper positioning of the airway assist device 84. Once
properly positioned in the vallecula 110, the medical professional
pulls on the handle 104 to move the tongue positioner 96 proximally
relative to the medical device tube 86. The distal end 100 engages
the patient's tongue 76 and pulls the tongue 76 proximally toward
the outside of the mouth of the patient 22. As a result, the
epiglottis 74 is also pulled proximally to further open the airway
of the patient 22. The teeth 1 08 ratchet on the collar 92 of the
airway holder 86 and prevent the tongue positioner 96 from moving
distally relative to the airway holder 86. During this procedure,
the patient 22 can breathe through the central passageway 86c of
the airway holder 86.
[0097] When the epiglottis 74 is pulled proximally, the medical
professional inserts the medical device 20, 120 into the central
passageway 86c of the airway assist device 84 and properly
positions the medical device 20, 120 in the patient's throat as
described herein.
[0098] After insertion of the medical device 20, 120, the medical
professional releases the 14 patient's tongue 76 by pulling the
tongue positioner 96 away from the airway holder 86 to disengage
the teeth 108 from the collar 92. The rigid plastic of the tongue
positioner 96 has enough flexibility to allow the elastic
deformation of the tongue positioner 96. Once the teeth 108 are
disengaged from the collar 92, the medical professional pushes the
tongue positioner 96 distally relative to the airway holder 86 to
cause the tongue 76 of the patient to move rearwardly into the
patient's mouth. Thereafter, the airway assist device 84 can be
removed from the patient's mouth by sliding it over the medical
device 20, 120.
[0099] Attention is invited to the airway assist device 184 shown
in FIGS. 17-20. With this embodiment, the ventilating tube 26, 126
has a collar 192 at its proximal end which extends=perpendicularly
from the ventilating tube 26, 126.
[0100] The airway assist device 184 includes a tongue positioner
196 having an elongated body 198 which is curved and has a distal
end 200 which has a radius which is substantially greater than the
radius at which the body 198 is curved. The edge 202 of the distal
end 200 is preferably arcuate. A handle 204 is provided at the
proximal end of the body 198 which enables a medical professional
to grasp the tongue positioner 196. The tongue positioner 196 is
preferably formed of a rigid plastic. The distal end 200 may be
covered with a soft material, such as silicone.
[0101] The airway holder 186 includes a pair of tabs 212 and a pair
of arms 216.
[0102] The tabs 212 extend upwardly from the distal end 200
proximate to, but spaced from, the edge 202. Each tab 212 is curved
and aligned with each other such that the ends of the tabs 212 face
each other. As a result, a space 214 is formed between each of the
tabs 212 and the distal end 200. This space 214 has a dimension
which is approximately equal to the inflatable cuff 32, 132 in the
deflated condition. The tabs 212 are spaced apart from each other a
distance which is generally equal to the width of the inflatable
cuff 32, 132.
[0103] The arms 216 extend upwardly from the body 198. Each arm 216
is generally L-shaped, with a first section 216a extending
perpendicularly from the body 198 and second sections 216b
extending perpendicularly from the first section 216a. The ends of
the second sections 216b are spaced apart from each other to form a
slot 218. The slot 218 has a width which is slightly less than the
diameter of the medical device 20, 120. The arms 216 and the body
198 form a medical device receiving passageway 186. A tooth 208
extends upwardly from the proximal end of the body 198 between the
arms 216. The tooth 208 is capable of engaging with the collar
192.
[0104] In use, the medical professional first inserts the medical
device 20, 120 into the airway assist device 184 by inserting the
medical device 20, 120 through the slot 218 and into the central
passageway 186 of the airway assist device 184. The arms 216 can
elastically flex outwardly as necessary to allow the medical device
20, 120 to pass through the slot 218. The cuff 32, 132 seats
underneath the tabs 212 such that the cuff 32, 132 is sandwiched
between the tabs 212 and the distal end 200.
[0105] The medical professional then inserts the combined medical
device 20, 120/airway assist device 184 into the mouth of the
patient 22. The airway assist device 184 is sandwiched between the
medical device 20, 120 and the tongue 76 of the patient 22. The
medical device 20, 120 slides against the hard palate and then
against the soft palate and partially into the pharynx of the
patient 22 until the distal end 100 of the airway assist device 84
enters into the vallecula 11 0 and the arcuate edge 202 engages the
tissues of the patient 22. The camera 66 on the medical device 20,
120 provides visual means to the medical professional to properly
insert the distal end 200 into the vallecula 110. The tongue
positioner 196 may slide along the patient's tongue 76. Once the
distal end 200 is positioned in the vallecula 110, the medical
professional pulls on the handle 204 to move the tongue positioner
196 proximally relative to the medical device 20, 120. The distal
end 200 engages the tongue 76 and pulls the tongue 76 proximally
toward the outside of the mouth of the patient 22. As a result, the
epiglottis 74 is also pulled proximally. During this procedure, the
patient 22 can breathe through the medical device 20, 120 as
described herein.
[0106] When the epiglottis 74 is pulled proximally, the medical
professional then pulls the medical device 20, 120 proximally to
release the cuff 32, 132 from the tabs 212. The freed medical
device 20, 120 then can be finally inserted with the distal end of
the medical device 20, 120 in the upper esophagus 80 of the patient
22 as discussed above.
[0107] After insertion of the medical device 20, 120, the medical
professional releases the patient's tongue 76 by pushing the tongue
positioner 196 distally into the patient's mouth to cause the
tongue 76 of the patient to move rearwardly. Thereafter, the airway
assist device 184 can be removed from the patient's mouth by
sliding it over the medical device 20, 120.
[0108] While the cuff 32, 132 has been described as inflatable, the
cuff 32, 132 can be formed of a soft material, such as silicone,
which will readily seal with the tissues in the glottis when the
medical device 20, 120 is seated therein.
[0109] FIGS. 21-25E show a medical device 220 which is inserted
into the throat of a patient 22 to determine the status of the
internal membranes of the patient 22 and to provide a means for
intubating the patient 22 with an endotracheal tube 24. The medical
device 220 includes an esophageal tube 226 and an intubating tube
228 which are connected together. The esophageal tube 226 is used
to monitor breath sounds of the patient 22, and the intubating tube
228 is used for intubation of the patient 22 using the endotracheal
tube 24 as described herein.
[0110] The esophageal tube 226 is formed from an elongated tube
wall which as shown in FIG. 23 has first and second portions 230,
232 which are arcuate and which are connected to each other by
curved end portions 234, 236. The first and second portions 230,
232 are preferably separate from each other by a distance of mm and
the end portions 234, 236 are preferably separated from each other
by a distance of 5 mm, however, the esophageal tube 226 may be
bigger or smaller. The proximal end of the esophageal tube 226 is
open and provides a proximal inlet opening 238. A generally conical
end portion 240, see FIG. 24, having an aperture 242 therethrough
is provided at the distal end of the tube wall. A central
passageway 244 extends through the tube wall and through the
conical end portion 240. The aperture 242 is in communication with
the central passageway 244. The esophageal tube 226 is curved along
its length. The esophageal tube 226 is formed of a relatively stiff
but compliant plastics material and is preferably formed by
extrusion.
[0111] A transmission lumen 68 like that of the first and second
embodiments of the medical device 20, 120 is provided and the
specifics are not repeated herein. The transmission lumen 68 seats
within the central passageway 244 of the esophageal tube 226 and
extends from the aperture 242. The transmission lumen 68 may seat
freely in the esophageal tube 226, may be attached to the
esophageal tube 226 by a friction fit with the aperture 242, or the
transmission lumen 68 can be otherwise affixed to the esophageal
tube 226.
[0112] The intubating tube 228 is formed from a small diameter
cylindrical wall 246 having a proximal open inlet (at the end
closest to the medical professional), an opposite distal open
outlet (at the end furthest away from the medical professional
during use of the medical device 220), a central passageway 248
extending therethrough, and a slot 250 which is in fluid
communication with the central passageway 248 and extends from the
proximal end (at inlet) to the distal end (at outlet) of the
intubating tube 228. The intubating tube 228 is curved along its
length. The intubating tube 228 has a diameter which is preferably
4 mm, however, the intubating tube 228 may be bigger or smaller.
The intubating tube 228 is formed of a relatively stiff but
compliant plastics material and is preferably formed by
extrusion.
[0113] A camera lumen 58/window 60 and camera 66 like that of the
first and second embodiments of the medical device 20, 120 are
provided and the specifics are not repeated herein.
[0114] The intubating tube 228 is affixed, such as by ultrasonic
welding, to the esophageal tube 226 along the second wall portion
232. The camera lumen 58 is affixed, such as by ultrasonic welding,
to the esophageal tube 226 along the second wall portion 232 and is
proximate to the intubating tube 228. The camera 66 and LED lights
62 (or other source of lighting, including a camera with its own
built-in lighting) can be incorporated into a single device which
is insertable and removeable from the camera lumen 58. The camera
66 is situated to provide the best angle for viewing the tissues of
the patient 22 when the medical device 220 is being inserted into
the throat of a patient 22. As a result, the intubating tube 228
and the camera lumen 58 are situated side-by-side. The inlets of
the esophageal tube 226, the intubating tube 228 and the camera
lumen 58 generally align with each other. The outlets do not align
with each other; instead, the outlets of the intubating tube 228
and the camera lumen 58 are spaced proximally a predetermined
distance from the outlet of the esophageal tube 226. The slot 250
in the intubating tube 228 is opposite to the point of weldment of
the intubating tube 228 to the esophageal tube 226 to provide a
means for insertion of the endotracheal tube 24 into the patient 22
as described herein.
[0115] In use, the medical professional inserts the medical device
220 through the mouth and into the throat of the patient 22. The
esophageal tube 226 slides against the hard palate and then against
the soft palate and into the pharynx of the patient 22. The medical
device 220 will flex to assume a curved shape to conform to the
throat of the patient 22. The medical device 220 does not block the
airway of the patient 22 so the patient 22 can breathe on his/her
own. The generally conical end wall 240 of the esophageal tube 226
enters into the upper end of esophagus 80 such that the
transmission lumen 68 is positioned within the esophagus 80 and is
located closest to the lungs of the patient 22. The distal outlet
of the intubating tube 228 is open to the glottis of the patient
22. During this entire procedure of insertion, the camera 66
provides constant visualization of the tissues during insertion of
the medical device 220 into the patient 22. Because the camera 66
provides constant visualization of the tissues during insertion of
the medical device 220 into the patient, the medical professional
can be assured that the medical device 220 is being properly
inserted and positioned in the throat of the patient 22 with
limited trauma to the patient 22. Since the camera lumen 58
terminates proximally of the esophageal tube 226 and does not enter
into the esophagus 80, the medical professional can see the vocal
folds 82 via the camera 66. Since the camera 66 is constantly
operating during insertion and through the entire medical
procedure, the medical professional can constantly visually confirm
that the patient 22 is breathing by the rhythmic opening and
closing of the vocal folds 82. The constant visualization of the
laryngeal inlet and the vocal folds 82 of the patient 22 can make
earlier diagnoses of issues, for example, but not limited to,
secretions, tumors, paralyzed vocal folds, apnea, bleeding, and
abnormal anatomy, as well as other potentially harmful effects to
the patient 22.
[0116] The medical device 220 is used to insert the endotracheal
tube 24. First, a stylet 252, which is known in the art, is
inserted into the intubating tube 228 and the distal end thereof
preferably extends past the distal end of the intubating tube. The
stylet 252 rides along the portion of the wall 246 of the
intubating tube 228 which is proximate to the point of weldment to
the esophageal tube 226, and, as such, will not be prone to falling
through the slot 250. Thereafter, the distal end of the
endotracheal tube 24 is threaded over the proximal end of the
stylet 252 (the portion of the stylet 252 which extends from the
proximal end of the intubating tube 228). As the endotracheal tube
24 is pushed along the stylet 252, the stylet 252 is pulled
upwardly to release it from the intubating tube 228 by the stylet
252 moving through the slot 250. As a result, the endotracheal tube
24 is guided along the proper path by the stylet 252 and the
intubating tube 228. Once the stylet 252 is completed released from
the intubating tube 228, the endotracheal tube 24 can be further
inserted through the vocal folds 82 of the patient 22 under the
visualization provided by the camera 66. The medical professional
can thus guide the endotracheal tube 24 through the vocal folds 82
and into the trachea, and inflate the cuff of the endotracheal tube
24, under the constant visualization provided by the camera 66. At
times, the medical device 220 may be advanced, pulled back, or
turned from side to side, to maintain the proper trajectory of the
endotracheal tube 24 through the vocal folds 82. This is easily
accomplished since there is constant visualization of the tissues
via the camera 66.
[0117] When the medical device 220 is seated in the throat of the
patient 22, the distal end of the transmission lumen 68 is
positioned within the esophagus 80 which enables breath and
heartbeat sounds to be easily transmitted through the transmission
lumen 68 to the medical professional monitoring the patient 22 as
described herein.
[0118] As a result of the structure of the medical device 220, the
intubating tube 228 is located away from the epiglottis 74 of the
patient 22 when the medical device 220 is positioned within the
patient 22. This minimizes the ability of the epiglottis 74 to
block the insertion of the endotracheal tube 24.
[0119] Because of the structure of the medical device 220, the
patient 22 does not have to be laying on his/her back to effect
intubation. The patient 22 can be sitting in a chair, or lying face
down.
[0120] Like that of the medical devices 20, 120, the video
information from the camera 66 and the information from the
transmission lumen 68 are transmitted to a microprocessor 82 via
appropriate means, such as wires, wireless, Bluetooth, etc., which
in turn can transmit the information to another computer, mobile
devices, a mobile station and the like, via appropriate means, such
as wires, wireless, Bluetooth, etc., and then this information can
be accessed by appropriate personnel. This microprocessor 82 can be
on-site where the procedure is being performed or can be remote
from the procedure site. For example, the information can be
supplied to the nurses' station and the nurse on duty will be able
to instantly know if the patient 22 is breathing by the visual
confirmation that the vocal folds are opening and closing and by
hearing breath and heart sounds. The medical professional will be
able to interpret the depth of anesthesia by looking at the
rhythmic movement of the vocal folds as well as other diagnoses
previously mentioned. Other medical personnel can be hundreds of
miles away and still be able to monitor, advise, confirm, and
diagnose without the patient 22 being in close physical proximity
to that medical personnel. Since the camera 66 is constantly
operating, medical personnel can tell at any time if the patient 22
is properly ventilated/intubated and is breathing.
[0121] FIGS. 26-318 show an alternate medical device 320 which is
inserted into the throat of a patient 22 to determine the status of
the internal membranes of the patient 22 and to provide a means for
intubating the patient 22 with an endotracheal tube 24. The medical
device 320 includes an intubating tube 326 and a sleeve 328 which
are connected together. The sleeve 328 is rotatable relative to the
intubating tube 326.
[0122] The intubating tube 328 is formed by an elongated
cylindrical body 330 which has a generally conical tip 332 at its
distal end. The intubating tube 228 is made of a flexible plastic
material. The body 330 has an elongated recess 334 therein which
generally extends from the proximal end of the body 330 to the
distal end of the body 330. The recess 334 is curved along its
length such that in cross-section it is generally arcuate as shown
in FIG. 28. As a result, a proximal curved ramp surface 336 is
formed by the recess 334 and extends from the outer surface of the
body 330 proximate to the distal end thereof distally to the apex
338 of the recess 334, and a distal curved ramp surface 340 is
formed by the recess 334 and extends from the outer surface of the
body 330 proximate to the distal end thereof proximally to the apex
338 of the recess 334. An enlarged cylindrical handle 342 is
provided at the distal end of the body 330. The tip 332 has a
weight provided therein to make the tip 332 heavier than the
remainder of the medical device 320. A camera lumen 58/window 60
and separate camera 66 like that of the previous embodiments of the
devices 20, 120, 220 are provided and the specifics are not
repeated herein. The camera lumen 58 is preferably positioned
beside the recess 334 and the distal end of the camera lumen 58 is
proximate to the distal end of the recess 334. The camera lumen 58
is suitably attached to the intubating tube 326 by suitable means,
such as ultrasonic welding. Alternatively, the camera lumen 58 can
be provided integral with the intubating tube 326.
[0123] The sleeve 328 is formed from generally C-shaped wall 344
which defines a slot 346 between the opposite ends of the C-shaped
wall 344. The sleeve 328 is made of a flexible plastic material.
The sleeve 328 has a length which is less than the length of the
recess 334, surrounds a portion of the body 330, and is rotatable
relative the body 330 to cover and uncover the majority of the
recess 334.
[0124] In use, the sleeve 328 is rotated relative to the body 330
such that the recess 334 is partially blocked. The proximal and
distal ends of the recess 334 are not blocked by the sleeve 328
such that proximal and distal openings 348, 350 are formed as shown
in FIG. 26. The patient 22 then swallows the medical device 320, or
the medical professional inserts the medical device 320 through the
mouth and into the throat of the patient 22. During this insertion,
the recess 334 is proximate to the tongue 76 of the patient 22. The
intubating tube 326 slides against the hard palate and then against
the soft palate and into the pharynx of the patient 22. The medical
device 320 will flex to assume a curved shape to conform to the
throat of the patient 22. The medical device 320 does not block the
airway of the patient 22 so the patient 22 can breathe on his/her
own. The generally conical tip 332 of the intubating tube enters
into the upper end of esophagus 80. The proximal opening 348 is
positioned exterior to the mouth of the patient 22. The distal
opening 350 is open to the glottis of the patient 22. During this
entire procedure of insertion, the camera 66 provides constant
visualization of the tissues of the patient 22. Because the camera
66 provides constant visualization, the medical professional can be
assured that the medical device 320 is being properly inserted and
positioned in the throat of the patient 22 with limited trauma to
the patient 22. Since the camera lumen 58 terminates proximally of
the intubating tube 326 and does not enter into the esophagus 80,
the medical professional can see the vocal folds 82 via the camera
66. Since the camera 66 is constantly operating during insertion
and through the entire medical procedure, the medical professional
can constantly visually confirm that the patient 22 is breathing.
The constant visualization of the laryngeal inlet and the vocal
folds 82 of the patient 22 can make earlier diagnoses of issues,
for example, but not limited to, secretions, tumors, paralyzed
vocal folds, apnea, bleeding, and abnormal anatomy, as well as
other potentially harmful effects to the patient 22.
[0125] The medical device 320 is then used to insert the
endotracheal tube 24. The distal end of the endotracheal tube 24 is
inserted into the proximal opening 348 and pushed along the length
of the recess 334 until the distal end and cuff of the endotracheal
tube 24 exit through the distal opening 350 and passes through the
vocal folds of the patient 22. The ramp surface 340 at the distal
end of the recess 334 aids in properly positioning the endotracheal
tube 24 relative to the glottis of the patient 22. The camera 66 is
used to determine the positioning of the endotracheal tube 24 and
the medical professional can adjust the position of the medical
device 320 using this constant visualization provided by the camera
66 to ensure proper entry of the endotracheal tube 24 through the
vocal folds 82 and into the trachea of the patient 22. At times,
the medical device 320 may be advanced, pulled back, or turned from
side to side, to maintain the proper trajectory of the endotracheal
tube 24 through the vocal folds 82. This is easily accomplished
since there is constant visualization of the tissues via the camera
66. Once the endotracheal tube 24 is properly positioned, the
sleeve 328 is rotated relative to the intubating tube 326 and the
endotracheal tube 24 is released from the intubating tube 326. The
medical device 320 can then be removed from the patient 22 if
desired.
[0126] A transmission lumen 68 like that of the previous devices
20, 120, 220 may be provided and attached to the intubating tube
326. If provided, when the medical device 320 is seated in the
throat of the patient 22, the distal end of the transmission lumen
68 is positioned within the esophagus 80 which enables breath and
heartbeat sounds to be easily transmitted along the length of the
transmission lumen 68 to the medical professional monitoring the
patient 22 as described herein.
[0127] As a result of the structure of the medical device 320, the
intubating tube 326 is located away from the epiglottis 74 of the
patient 22 when the medical device 320 is positioned within the
patient 22. This minimizes the ability of the epiglottis 74 to
block the insertion of the endotracheal tube 24.
[0128] Because of the structure of the medical device 320, the
patient 22 does not have to be laying on his/her back to effect
intubation. The patient 22 can be sitting in a chair, or lying face
down. The medical devices 220, 320 provide a new methodology of
intubating the patient 22 by placing the medical device 220, 320
into the esophagus 80 of the patient 22 and working upwardly toward
the trachea.
[0129] Like that of the previous devices 20, 120, 220, the video
information from the camera 66 and the information from the
transmission lumen 68 are transmitted to a microprocessor 82 via
appropriate means, such as wires, wireless, Bluetooth, etc., which
in turn can transmit the information to another computer, mobile
devices, a mobile station and the like, via appropriate means, such
as wires, wireless. Bluetooth, etc., and then this information can
be accessed by appropriate personnel. This microprocessor 82 can be
on-site where the procedure is being performed or can be remote
from the procedure site. For example, the information can be
supplied to the nurses' station and the nurse on duty will be able
to instantly know if the patient 22 is breathing by the visual
confirmation that the vocal folds are opening and closing and by
hearing breath and heart sounds. The medical professional will be
able to interpret the depth of anesthesia by looking at the
rhythmic movement of the vocal folds 82 as well as other diagnoses
previously mentioned. Other medical personnel can be hundreds of
miles away and still be able to monitor, advise, confirm, and
diagnose without the patient 22 being in close physical proximity
to that medical personnel. Since the camera 66 is constantly
operating, medical personnel can tell at any time if the patient 22
is properly ventilated/intubated and is breathing.
[0130] As an alternative, the endotracheal tube 24 can be seated
within the recess 334 prior to insertion of the medical device 320
into the patient 22. The distal portion of the endotracheal tube 24
is preferably trapped between the sleeve 328 and the body 330 when
the medical device 320 is first inserted to prevent damage to the
cuff of the endotracheal tube 24.
[0131] FIG. 32 shows a medical device 420 which includes an
endotracheal tube 24 having the camera lumen 58/window 60 affixed
thereto. The camera lumen 58/window 60 and separate camera 66 like
that of the previous embodiments of the devices 20, 120, 220, 320
are provided and the specifics are not repeated herein.
[0132] As is known in the art, the endotracheal tube 24 includes a
cylindrical wall 24a formed of a relatively stiff but compliant
plastics material and is preferably formed by extrusion which has a
central passageway therethrough, a cuff 24b attached proximate to
the distal end of the wall 24a which is inflatable via inflation
line 44 which is formed by a small-diameter flexible plastic tube.
The proximal end of the tube 24a has a connector 24c for connecting
the endotracheal tube 24 to a ventilating machine in a known
manner. The prior art endotracheal tube 24 is modified in that a
mark 426 is provided thereon which is preferably one inch proximal
of the cuff 24b.
[0133] The camera lumen 58 extends along the length of the wall 24a
and the distal end of the camera lumen 58 is proximate to the mark
426. The camera lumen 58 is suitably attached to the wall 24a by
suitable means, such as ultrasonic welding. Alternatively, the
camera lumen 58 can be provided integral with the wall 24a.
[0134] In use, the medical professional inserts the medical device
420 through the mouth and into the throat of the patient 22. The
endotracheal tube 24 then passes through the vocal folds and into
the trachea of the patient 22. The medical device 420 will flex to
assume a curved shape to conform to the throat of the patient 22.
If desired, the medical device 420 can be inserted into the patient
22 using the medical device 20, 120. During this entire procedure
of insertion, the camera 66 provides constant visualization of the
tissues during insertion of the medical device 420 into the patient
22. Because the camera 66 provides constant visualization of the
tissues during insertion of the medical device 420 into the
patient, the medical professional can be assured that the medical
device 420 is being properly inserted and positioned in the throat
of the patient 22 with limited trauma to the patient 22. The
medical professional can adjust the position of the medical device
420 using this constant visualization provided by the camera 66 to
ensure proper entry of the endotracheal tube 24 through the vocal
folds and into the trachea of the patient 22. At times, the medical
device 420 may be advanced, pulled back, or turned from side to
side, to maintain the proper trajectory of the endotracheal tube 24
through the vocal folds. This is easily accomplished since there is
constant visualization of the tissues via the camera 66.
[0135] The portion of the endotracheal tube 24 distal to the mark
426 passes through the vocal folds, however, the camera lumen 58
does not pass through the vocal folds. As such, the camera 66 is
used to continuously visualize the vocal folds and to view the
portion of the endotracheal tube 24 which is distal to the vocal
folds (when the vocal folds are open) to determine if the
endotracheal tube 24 has been properly positioned. Since camera
lumen 58 does not pass through the vocal folds, this provides a
smaller dimension of material passing through the vocal folds.
Since the camera 66 is constantly operating during insertion and
through the entire medical procedure, the medical professional can
constantly visually confirm that the patient 22 is breathing. The
constant visualization of the laryngeal inlet and the vocal folds
of the patient 22 can make earlier diagnoses of issues, for
example, but not limited to, secretions, tumors, paralyzed vocal
folds, apnea, bleeding, and abnormal anatomy, as well as other
potentially harmful effects to the patient 22.
[0136] A transmission lumen (not shown) like that of the previous
devices 20, 120, 220, 320 may be provided and attached to the
endotracheal tube 24. If provided, when the medical device 420 is
seated in the throat of the patient 22, the distal end of the
transmission lumen is positioned proximate to the esophagus which
enables breath and heartbeat sounds to be easily transmitted
through the transmission lumen to the medical professional
monitoring the patient 22.
[0137] FIGS. 33-35 shown a modified medical device 420' to that
shown in FIG. 32 which includes a modified endotracheal tube 24'
and a modified camera lumen 58'. The camera lumen 58' is attached
to the wall 24a by means which allow the camera lumen 58 to slide
relative to the wall 24a. As shown, a dovetail joint 428, formed of
a tongue on one of the camera lumen 58 and the wall 24a and of a
groove on the other of the camera lumen 58 and the wall 24a, mounts
the camera lumen 58 to the wall 24a. A small cylindrical tube 430
is affixed to the wall 24a by suitable means, such as ultrasonic
welding, and is provided between the cuff 24b and the wall 24a. A
passageway 432 is provided by the small cylindrical tube 430. The
distal end of the tube 430 is sealed with a window. The small
cylindrical tube 430 is positioned at the end of the structure
forming the portion of the dovetail joint 428 on the wall 24b. The
camera lumen 58' has a handle 434 attached to its distal end to
allow the medial professional to grasp the camera lumen 58' to
manipulate the position of the distal end of the camera lumen 58'
as described herein.
[0138] In use, the medical professional can grasp the handle 434 to
slide the camera lumen 58, with the camera 60 mounted therein,
along the wall 24a via the inter-engagement of dovetail joint 428
and to slide the distal end of the camera lumen 58/camera 66
through the small cylindrical tube 430. This allows the medical
professional to continuously view the tissues of the patient on
either side of the vocal folds of the patient 22.
[0139] A transmission lumen 68 is affixed to the endotracheal tube
24', preferably to the wall 24a opposite to that where the camera
lumen 58' is located. When the medical device 420 is seated in the
throat of the patient 22, the distal end of the transmission lumen
68 is positioned proximate to the esophagus which enables breath
and heartbeat sounds to be easily transmitted through the
transmission lumen 68 to the medical professional monitoring the
patient 22.
[0140] In the embodiments of the medical device 420, 420', the
camera lumen 58, 58'/window 60 could instead be mounted within the
endotracheal tube 24, 24', with the mark 426 provided on an
interior surface of the endotracheal tube 24, 24'.
[0141] FIGS. 36-37B show a medical device 520 formed of a dual
branch endotracheal tube 524 which incorporates the sealed camera
lumen 58/window 60 and separate camera 66 which can be inserted
therein and removed therefrom as described herein. The camera lumen
58/window 60 and separate camera 66 are like that of the previous
embodiments of the devices 20, 120, 220, 320, 420, 420' and the
specifics are not repeated herein. The dual branch endotracheal
tube 524 is used to separate the left and right bronchus 526, 528
from each other for surgical purposes and can be used as a normal
endotracheal tube which is normally seated in the trachea of the
patient 22. In the prior art, separation of the left and right
bronchus 526, 528 from each other is usually accomplished using two
lumens which tends to be cumbersome.
[0142] The endotracheal tube 524 is formed from a main cylindrical
wall 530 having a proximal end (end closest to the medical
professional during use) and a distal end (end furthest from the
medical professional during use), a first branch cylindrical wall
532 extending from the distal end of the main wall 530, and second
branch cylindrical 534 wall extending from the distal end of the
main wall 530. The first and second branch walls 532, 534 are
smaller in dimension than the main wall 530, but when the
dimensions of the branch walls 532, 534 are combined, this
dimension is approximately equal to the dimension of the main wall
530. As a result, the endotracheal tube 524 has a single inlet port
at its proximal end and first and second outlet ports at its distal
end. A central passageway extends through the main wall 530, and
branch passageways extend through the branch walls 532, 534, each
of which are in communication with the central passageway through
the main wall 530. The distal end of the first branch wall 532 has
a first port 536 which terminates proximally of the distal end of
the second branch wall 534 which forms a second port 538. The
second port 538 is angled relative to the first port 536.
[0143] The proximal end of the endotracheal tube 524 is closed with
a cap 538. The cap 538 has a first aperture 540 therethrough which
can be closed with a plug 542 in a known manner, and a second
aperture 544 provided through an extension 544 which extends
perpendicular to the centerline of the main wall 530. A ventilator
is attached to the extension 544 in a known manner to provide
positive air pressure to the medical device 520.
[0144] An inflatable cuff 548 surrounds the main wall 530 at a
position which is spaced from the branch walls 532, 534. An
inflation line 550 and its associated pilot 552 is attached to this
inflatable cuff 548. An inflatable cuff 554 surrounds the first
branch wall 532 at a position which is spaced from the distal port
536. An inflation line 554 and its associated pilot 556 is attached
to this inflatable cuff 554. An inflatable cuff 558 (shown in full
line in the figures for ease in understanding) is positioned
interiorly within the first branch wall 532 at a position which is
spaced from the distal port 536. An inflation line 560 and its
associated pilot 562 is attached to this interior inflatable cuff
558. The camera lumen 58/window 60 extends through the aperture 540
in the cap 538, through the central passageway in the main wall 530
and into the second branch passageway through the second wall 534
and preferably terminates at, or proximate to, the second port 538.
The cap 538 and the lumen 58 can form a frictional fit to prevent
the camera lumen 58 from 28 disengaging from the cap 538. The
camera 66 is then is inserted into the camera lumen 58.
[0145] The medical professional inserts the medical device 520,
with all of the cuffs 548, 554, 558 in the deflated condition,
through the mouth and into the throat of the patient 22. This
insertion can be effected using the medical device 20, 120 as
described above. The camera 66 mounted in the medical device 520
provides constant visualization of the tissues of the patient 22
during this insertion.
[0146] The medical device 520 can be placed in the patient 22 in
one of the three positions. In a first position, the medical device
520 can be placed such that the main wall 530 and the second branch
wall 534 are in the trachea of the patient 22 and past the vocal
folds 82, and the first branch wall 532 is in the left main stem
bronchus 526 of the patient 22, as shown in FIG. 37 A. In a second
position, the medical device 520 can be placed such that the main
wall 530 and the second branch wall 534 are in the trachea of the
patient 22 and past the vocal folds 82, and the first branch wall
532 is in the right main stem bronchus of the patient 22 (not
shown). In a third position, the medical device 520 can be placed
such that the main wall 530 and both branch walls 532, 534 are in
the trachea of the patient 22, past the vocal folds 82, but not
past the carina 84, as shown in FIG. 37B.
[0147] In use, the medical professional inserts the medical device
520 into the patient 22. If desired, the medical device 520 can be
inserted into the patient 22 using the medical device 20, 120. The
camera 66 is used to continuously visualize the position of the
medical device 520 during this insertion. For surgery, the medical
device 520 is positioned such that the main wall 530 and the second
branch wall 534 seat in the trachea of the patient 22 and the first
branch wall 532 seats into one of the bronchus of the patient 22
(left as shown in the drawings). Since the camera 66 is positioned
in the trachea of the patient 22, the carina 84 of the patient 22
is always within view and the medical professional will know that
the first branch wall 532 is positioned within the bronchus of the
patient 22. Once properly positioned, the external cut's 548, 554
are inflated to hold the medical device 520 in place. Cuff 548
engages with the trachea of the patient 22, and cuff 554 engages
with the bronchus of the patient 22. The camera 66 provides visual
confirmation that the cuff 554 has been inflated in the bronchus.
When the surgeon wants to operate on the lung, the medical
professional disconnects the ventilator from extension 544 to allow
both lungs to deflate. Thereafter, the internal cuff 558 is
inflated to block airflow through the branch wall to the bronchus
in which the first branch wall 532 is seated. Thereafter,
ventilation is resumed such that the lung which will not be
operated upon is functioning. Once the medical procedure is
completed, all of the cuffs 548, 554, 558 are deflated and the
medical device 520 is pulled proximally to remove the second branch
wall 532 from the bronchus. As a result, the main wall 530 and both
branch walls 532, 534 are seated within the trachea. The camera 66
again provides visual confirmation of the position of the medical
device 520 in the trachea as the carina 84 can be seen.
[0148] Once the medical device 520 is positioned completely in the
trachea, the pilots 556, 560 to the inflation lines 554, 560 to the
distal cuffs 554, 558 are cut as shown in FIG. 37B to prevent their
inflation. The main cuff 548 is then re-inflated and the medical
device 520 functions as a normal endotracheal tube. This medical
device 520 can be modified to include the camera lumen shown in
FIGS. 32-35 to allow the medical professional to view the tissues
above or below the vocal folds 82.
[0149] This structure presents a distinct advantage over prior art
double lumen endotracheal tubes. Prior art double lumen
endotracheal tubes are much wider than the present medical device
520, which may cause undue harm to the patient.
[0150] FIGS. 38-39C show a medical device 620 which is a modified
bronchoscope which has the camera lumen 58/window 60 and separate
camera 66. The camera lumen 58/window 60 and separate camera 66 are
like that of the previous embodiments of the devices 20, 120, 220,
320 and the specifics are not repeated herein.
[0151] In the prior art, bronchoscopes use a fiber optic line, the
position of which can be manipulated by the mechanism at the
proximal end of the fiber optic line. As is known in the prior art,
the handle on the mechanism can be toggled to cause the fiber optic
line to curved either to the left or to the right. Prior art
bronchoscopes are expensive because of the built-in fiber optics
and if this fiber optic line is compromised, the entire
bronchoscope must be replaced.
[0152] The medical device 620 replaces the fiber optic line of the
prior art bronchoscope, with an elongated plastic line 626 which is
flexible, yet maintains its rigidity. The position of the plastic
line 626 is manipulated by the same mechanism 628 which is known in
the prior art bronchoscope to cause the plastic line 628 to curve
to the left or to the right (shown in FIGS. 39B and 39C) by
toggling the handle 630.
[0153] The medical device 620 has the camera lumen 58/window 60
affixed to the elongated plastic line 626 by suitable means, such
as ultrasonic welding, such that the plastic line 626 and the
camera lumen 58 are side-by-side. The distal ends of the plastic
line 626 and the camera lumen 58 preferably terminate at the same
point. As is described herein with respect to the other
embodiments, the camera 66 is removably placed in this sealed
camera lumen 58.
[0154] In use, the medical professional inserts the plastic line
626/camera lumen 58 with the camera 66 mounted therein into the
patient 22 and uses it like a prior art bronchoscope. The camera 66
provides constant visualization of the tissues of the patient
22.
[0155] The medical device 620 can be used in place of the camera
lumen 58 in the medical devices 420, 420'. 520 disclosed herein.
The medical device 620 can be used to place the medical devices
420, 420', 520 in the patient 22.
[0156] FIG. 40 shows a medical device 720 which is used to provide
suction to a cavity of the patient 22, such as the lungs, the chest
cavity, etc. to drain fluids/air from the cavity. The medical
device 720 includes a cylindrical suction tube 726 which is known
in the art which is attached to the camera lumen 58/window 60 and
separate camera 66. The camera lumen 58/window 60 and separate
camera 66 are like that of the previous embodiments of the devices
20, 120, 220, 320, 420, 420'. 520, 620 and the specifics are not
repeated herein.
[0157] The suction tube 726 has a proximal open inlet (at the end
closest to the medical professional), an opposite distal outlet (at
the end furthest away from the medical professional during use) and
a central passageway extending therethrough. The suction tube 726
is curved along its length. The distal end of the suction tube 726
has a series of perforations 728. The suction tube 726 is formed of
a relatively stiff but compliant plastics material and is
preferably formed by extrusion. The proximal end of the suction
tube 726 has a connector 730 attached thereto as is known in the
art. The connector 730 has two ports 732, 734 which are
perpendicular to each other. As is known in the art, port 732 is
attached to a suction device (not shown); the ribs 736 on the port
732 help retain the suction device thereon. When the suction device
is turned on, air will be entrained from the open port 734. The
medical, professional places his/her thumb or otherwise blocks the
port 734 to cause the suction tube 726 to suck fluids from the
distal end through the perforations 728.
[0158] The camera lumen 58 is affixed, such as by ultrasonic
welding, to the suction tube 726, such that the suction tube 726
and the camera lumen 58 are side-by-side. The distal ends of the
suction tube 726 and the camera lumen 58 preferably terminate at
the same point. As is described herein with respect to the other
embodiments, the camera 66 is removably placed in this sealed
camera lumen 58.
[0159] In use, the medical professional inserts the medical device
720 through the endotracheal tube 24, through a drain line (not
shown) or directly into the patient's cavity. The camera 66
provides constant visualization of the tissues during insertion and
use of the medical device 720 into the patient 22 and the medical
professional can be assured that the medical device 720 is being
properly positioned in the patient 22 with limited trauma to the
patient 22. The constant visualization of the tissues of the
patient 22 can make earlier diagnoses of issues, for example, but
not limited to, secretions, tumors, paralyzed vocal folds, apnea,
bleeding, and abnormal anatomy, as well as other potentially
harmful effects to the patient 22.
[0160] The medical device 720 can be used in combination with many
of the other medical devices disclosed herein.
[0161] FIG. 41 shows a medical device 820 which provides a stylet
826 which is known in the art which is attached to the camera lumen
58/window 60 and separate camera 66. The camera lumen 58/window 60
and separate camera 66 are like that of the previous embodiments of
the devices 20, 120, 220, 320, 420, 420', 520, 620, 720 and the
specifics are not repeated herein.
[0162] The camera lumen 58 is attached to the stylet 826 by
suitable means, such as ultrasonic welding or a dovetail joint
between the camera lumen 58 and the stylet 82, such that the stylet
826 and the camera lumen 58 are side-by-side. The distal ends of
the stylet 826 and the camera 32 lumen 58 preferably terminate at
the same point. As is described herein with respect to the other
embodiments, the camera 66 is removably placed in this sealed
camera lumen 58 to continuously visualize the path the stylet 826
takes during insertion into the patient 22.
[0163] FIG. 42 shows a medical device 920 which provides a tube
changer 926 which is known in the art which is attached to the
camera lumen 58/window 60 and separate camera 66. The camera lumen
58/window 60 and separate camera 66 are like that of the previous
embodiments of the devices 20, 120, 220, 320, 420, 420'. 520, 620,
720, 820 and the specifics are not repeated herein.
[0164] As is known in the art, tube changers are used to change one
endotracheal tube for another endotracheal tube. The tube changer
926 is formed of an elongated, relatively stiff but compliant
plastics material and is preferably formed by extrusion. The tube
changer 926 has a proximal end, a distal end and a central
passageway therethrough. The proximal end of the changer 926 is
capped with a connector 930 that can be connected to a
ventilator.
[0165] The camera lumen 58 is attached to the tube changer 926 by
suitable means, such as ultrasonic welding or a dovetail joint
between the camera lumen 58 and the tube changer 926, such that the
tube changer 926 and the camera lumen 58 are side-by-side. The
distal ends of the tube changer 926 and the camera lumen 58
preferably terminate at the same point. As is described herein with
respect to the other embodiments, the camera 66 is removably placed
in this sealed camera lumen 58 to continuously visualize the path
the tube changer 926 takes during insertion into the patient
22.
[0166] In use, the medical professional feeds the medical device
920 through the endotracheal tube that is to be removed until the
distal end of the medical device 920 is positioned proximate to the
carina 84 of the patient 22. The medical professional can see the
distal end of the endotracheal tube as the camera 66 passes thereby
and can see the carina 84. The medical professional uses the camera
66 to constantly visualize the tissues and to determine when the
distal end of the medical device 920 is proximate to the carina 84.
The connector 930 is removed from the medical device 920 and the
endotracheal tube is then removed from the patient 22. If
necessary, the patient 22 can be ventilated through the medical
device 920 by attaching the connector 930 to the tube changer 926
and attaching a ventilator to the connector 930. In order to insert
the new endotracheal tube, the connector 930 is removed from the
tube changer 926. The new endotracheal tube (which may be one of
the endotracheal tube shown in FIGS. 32-37B) is fed over the
medical device 920 and into the trachea of the patient 22. The
medical device 920 is then pulled proximally. Once the distal end
of the new endotracheal tube is sighted using the camera 66, the
medical professional must also be able to see the carina 84 to
ensure that the new endotracheal tube was not inserted too far into
the trachea (if the endotracheal tube is positioned too deeply, the
endotracheal tube can abut the carina 84, or can be positioned in
one of the bronchus of the patient 22). The new endotracheal tube
can be repositioned at this time if necessary using the camera 66
for the proper positioning. Once the new endotracheal tube is
properly positioned, the medical device 920 is removed from the new
endotracheal tube. The camera 66 can be removed from the camera
lumen 58 and placed into the new endotracheal tube as discussed
herein.
[0167] The tube changer 926 may have graduation marks 932 thereon
between the ends which may be used to double check the position of
the new endotracheal tube in accordance with the known Seldinger
technique. Since the camera 66 provides visual confirmation of the
correct placement of the endotracheal tube, the graduations marks
932 are not necessary.
[0168] FIGS. 43 and 44 show a medical device 1020 which is used to
manipulate the position of the epiglottis 74 of the patient 22 for
intubation purposes which is similar to a medical device commonly
sold under the trademark GLIDESCOPE.RTM.) which is owned by
Verathon Medical (Canada) ULC. The medical device 1020 has a handle
1026 and curved body 1028 extending from one end of the handle
1026. The handle 1026 has a finger grip handle 1030 extending
therefrom at a forty-five degree angle. The finger grip handle 1030
can be flexed relative to the handle 1026. A tip 1032 is provided
at the opposite end of the body 1028 and can be flexed relative to
the body 1028. A mechanism (not shown), which is known in the art,
is embedded in the medical device 1020 and connects the finger grip
handle 1030 to the tip 1032. When the medical device 1020 is held
by a medical professional, the handle 1 026 seats in the palm of
the medical professional and the fingers of the medical
professional wrap around the finger grip handle 1030. When the
medical professional squeezes his/her fingers, the finger grip
handle 1030 moves toward the handle 1026 and this causes the
internal mechanism to move the tip 1032 toward the handle 1026.
This is known in the prior art.
[0169] The prior art medical device 1020 has been modified in two
respects. First, integral camera lumen 58/window 60 and LED lights
62 are provided. The integral camera lumen 58 extends along a
section of the body 1028. The window 60 is sealed to the camera
lumen 58 to prevent the entry of fluids and other matter into the
camera lumen 58. This camera lumen 58 terminates at approximately
the midpoint of the body 1028. Second, a disposable sleeve 1034
which conforms to the shape of the tip 1032 and body 1028 is
provided. The sleeve 1034 is formed of a thin plastic material. The
sleeve 1034 has apertures 1036, 1038 therethrough to remove any
obstruction from the view of the camera 66 and to allow the lights
62 to shine therethrough in an unobstructed manner. The lights 62
can be incorporated into the sleeve 1034 instead of the body
1028.
[0170] In use, the camera 66 is inserted into the camera lumen 58
and the sleeve 1034 covers the tip 1032 and body 1028. The
apertures 1036, 1038 in the sleeve 1034 align the window 60 and the
lights 62. The medical professional inserts the medical device 1
020 into the mouth of the patient 22 and the tip 1032 enters into
the vallecula 110. The body 1028 generally mirrors the shape of the
patient's tongue 76. The sleeve 1034 prevents the patient's tissues
and secretions from contacting the remainder of the medical device
1020. The handle 1026 seats in the palm of the medical professional
and the fingers of the medical professional wrap around the finger
grip handle 1030. The entry of the tip 1032 into the mouth of the
patient 22 is continuously visualized by the camera 66 in the
sealed camera lumen 58. Once the tip 1032 is properly positioned in
the vallecula 110, the medical professional's fingers are squeezed
and the finger grip handle 1030 moves toward the handle 1026. This
causes the internal mechanism in the body 1028 to move the tip 1032
toward the handle 1026. The tip 1032 engages the patient's tongue
76 and pulls the tongue 76 proximally toward the outside of the
mouth of the patient 22. As a result, the epiglottis 74 is also
pulled proximally to further open the airway of the patient 22.
[0171] With the epiglottis 74 pulled proximally, the medical
professional inserts the medical device 20, 120 or the medical
device 420, 420', 520 in the patient's throat as described herein.
The camera 66 can be removed from the medical device 1020 and
inserted into the medical device 20, 120 or medical device 420,
420', 520.
[0172] In all of the devices 20, 120, 220, 320, 420, 420'. 520,
620, 720, 820, 920, 1020 described herein, the same camera 66 can
be easily slid into and removed from all of the sealed camera
lumens 58. As a result, the camera 66, which is an expensive
component, can be used in multiple different devices such as those
as shown (or other devices which have such a sealed camera lumen)
by removing it from one device and inserting it into another
device. Since the camera lumen 58 is sealed, it is not necessary to
sterilize the camera 66 between uses as the camera 66 does not come
into contact with the tissues and/or secretions of the patient
22.
[0173] While specific lumens (camera lumen, transmission lumen) are
shown and described with respect to each of the embodiments, it is
to be understood that other lumens can also be provided each of the
embodiments. Such other lumens could be used for insertion of other
tools into the patient 22, for the providing oxygen to the patient
22, for suctioning fluids from the patient 22 and the like.
[0174] A transmission lumen 68 can be used in any of the devices
20, 120, 220, 320, 420, 420', 520, 620, 720, 820, 920, 1020. If
such a transmission lumen 68 is provided, a speaker (not shown) can
included to audibilize the breath and heart sounds from the patient
22 transmitted from the transmission lumen 68. The sound from the
transmission lumen 68 can be magnified and externalized to the
devices. The speaker can be disseminated electronically. The
speaker can be provided in any one of the lumens or tubes, or
suitably connected to the lumens or tubes.
[0175] FIGS. 45 and 46 show a medical device 1120 which is allows a
medical professional, such as an obstetrician/gynecologist
(OB/GYN), to easy view the cervix of a patient to determine the
amount of dilation of the cervix. The medical device 1120 includes
a cylindrical tube 1126 which has the camera lumen 58/window 60
attached thereto. The separate camera 66 is insertable and
removable from the camera lumen 58. The camera lumen 58/window 60
and separate camera 66 are like that of the previous devices 20,
120, 220, 320, 420, 420', 520, 620, 720, 820, and the specifics are
not repeated herein.
[0176] The tube 1126 has a proximal open inlet 1128 (at the end
closest to the medical professional), an opposite distal outlet
1130 (at the end furthest away from the medical professional during
use) and a central passageway 1132 extending therethrough. The tube
1126 may be curved along its length, or it may be straight. The
tube 1126 is formed of a relatively stiff but compliant plastics
material and is preferably formed by extrusion.
[0177] The camera lumen 58 is affixed, such as by ultrasonic
welding, to the tube 1126, such that the tube 1126 and the camera
lumen 58 are side-by-side. The camera lumen 58 can be on the
external surface or external surface of the tube 1126. The proximal
and distal ends of the tube 1126 and the camera lumen 58 preferably
are at the same points. As is described herein with respect to the
other embodiments, the camera 66 is removably placed in this sealed
camera lumen 58. As in the previous devices, an LED light 62 can be
provided at the distal end 1130 of the tube 1132 or camera lumen 58
to illuminate the tissues, or in the camera 66 itself.
[0178] In use, the medical professional inserts the medical device
1120 into the patient's vagina such that the cervix can be seen.
The camera 66 provides constant visualization of the cervix and
tissues during insertion and use of the medical device 1120 in the
patient and the medical professional can be assured that the
medical device 1120 is being properly positioned in the patient
with limited trauma to the patient. The constant visualization of
the tissues of the patient can make earlier diagnoses of issues,
for example, but not limited to, secretions, tumors, bleeding, and
abnormal anatomy, as well as other potentially harmful effects to
the patient.
[0179] After the medical device 1120 is positioned, the medical
professional can use a tool, such as the tool 1134 shown in FIG.
46, to measure the amount of dilation of the cervix. The medical
device 1120 remains in place during the labor. The camera 66
provides a constant stream of information to the medical
professional regarding the amount of dilation of the patient.
[0180] In any of the devices 20, 120, 220, 320, 420, 420', 520,
620, 720, 820, 920, 1020, 1120, the video information from the
camera 66 and/or the information from the transmission lumen 68 are
transmitted to a microprocessor 82, FIG. 11, via appropriate means,
such as wires, wireless, Bluetooth, etc., which in turn can
transmit the information to another computer, mobile devices, a
mobile station and the like, via appropriate means, such as wires,
wireless, Bluetooth, etc., and then this information can be
accessed by appropriate personnel. This microprocessor 82 can be
on-site where the procedure is being performed or can be remote
from the procedure site. For example, the information can be
supplied to the nurses' station and the nurse on duty will be able
to instantly know if the patient 22 is breathing by the visual
confirmation that the vocal folds are opening and closing and by
hearing breath and heart sounds. The medical professional will be
able to interpret the depth of anesthesia by looking at the
rhythmic movement of the vocal folds as well as other diagnoses
previously mentioned. Other medical personnel can be hundreds of
miles away and still be able to monitor, advise, confirm, and
diagnose without the patient 22 being in close physical proximity
to that medical personnel. Since the camera 66 is constantly
operating, medical personnel can tell at any time if the patient 22
is properly ventilated/intubated and is breathing.
[0181] In any of the devices 20, 120, 220, 320, 420, 420', 520,
620, 720, 820, 920, 1020, 1120, the LED light 62 can be provided at
the distal end of the device 20, 120, 220, 320, 420, 420', 520,
620, 720, 820, 920, 1020, 1120, in camera lumen 58, or in the
camera 66 itself to illuminate the tissues. In addition, multiple
LED lights 62 can be provided in each of the 20, 120, 220, 320,
420, 420', 520, 620, 720, 820, 920, 1020, 1120 and can be located
on different parts of the devices 20, 120, 220, 320, 420, 420',
520, 620, 720, 820, 920, 1020, 1120.
[0182] While preferred embodiments of the present invention are
shown and described, it is envisioned that those skilled in the art
may devise various modifications of the present invention without
departing from the spirit and scope of the appended claims.
* * * * *