U.S. patent application number 10/405511 was filed with the patent office on 2003-10-09 for method and apparatus for ventilation / oxygenation during guided insertion of an endotracheal tube.
Invention is credited to Christopher, Kent L..
Application Number | 20030188750 10/405511 |
Document ID | / |
Family ID | 27410910 |
Filed Date | 2003-10-09 |
United States Patent
Application |
20030188750 |
Kind Code |
A1 |
Christopher, Kent L. |
October 9, 2003 |
Method and apparatus for ventilation / oxygenation during guided
insertion of an endotracheal tube
Abstract
An endotracheal tube can be inserted into a patient's trachea
during resuscitation by using a face mask and a curved guide. The
guide is inserted through a flexible port in the face mask and has
a curved distal portion that extends into the patient's mouth and
hypopharynx. The patient is initially resuscitated by supplying a
flow of air/oxygen through the mask. For example, a resuscitation
bag can be connected to a rotatable ventilation port on the face
mask. Alternatively, a resuscitation attachment with an air filter
and one-way valve can be removably attached to the ventilation port
of the face mask to enable a health care provider to directly
resuscitate the patient. An endotracheal tube is inserted over the
distal end of a fiber optic probe. Resuscitation, oxygenation, or
artificial ventilation continue without interruption while the
fiber optic probe and endotracheal tube are inserted through a
flexible port at the proximal end of the curve guide and then
advanced along the guide into the patient's airway, thereby
allowing the physician to carefully guide the fiber optic probe and
endotracheal tube to a position past the larynx while resuscitation
continues. The fiber optic probe is then removed from within the
endotracheal tube and the mask is removed while leaving the
endotracheal tube in place within the trachea.
Inventors: |
Christopher, Kent L.;
(Denver, CO) |
Correspondence
Address: |
DORR CARSON SLOAN & BIRNEY, PC
3010 EAST 6TH AVENUE
DENVER
CO
80206
|
Family ID: |
27410910 |
Appl. No.: |
10/405511 |
Filed: |
April 2, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10405511 |
Apr 2, 2003 |
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09707350 |
Nov 6, 2000 |
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6543446 |
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09707350 |
Nov 6, 2000 |
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09411610 |
Oct 1, 1999 |
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6405725 |
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09411610 |
Oct 1, 1999 |
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08974864 |
Nov 20, 1997 |
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5964217 |
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08974864 |
Nov 20, 1997 |
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08607332 |
Feb 26, 1996 |
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5694929 |
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Current U.S.
Class: |
128/207.14 ;
128/207.16 |
Current CPC
Class: |
A61M 16/0084 20140204;
A61M 16/08 20130101; A61M 16/0495 20140204; A61M 16/0409 20140204;
A61M 16/0493 20140204; A61M 2205/0238 20130101; A61M 2205/0222
20130101; A61M 16/06 20130101; A61M 16/107 20140204; A61M 16/0488
20130101 |
Class at
Publication: |
128/207.14 ;
128/207.16 |
International
Class: |
A61M 016/00 |
Claims
I claim:
1. An apparatus for resuscitation of a patient by a health care
provider and for guiding insertion of an endotracheal tube into the
trachea of the patient, said apparatus comprising: a face mask to
cover a patient's mouth having a face mask port, and a ventilation
port allowing a flow of air/oxygen into the face mask to
resuscitate the patient; a guide removably extending through the
face mask port having a distal portion for insertion into a
patient's mouth and hypopharynx to direct insertion of an
endotracheal tube into a patient's trachea, and a tubular proximal
end; and a guide cap removably insertable onto the proximal end of
the guide, said guide cap having: (a) a guide cap passageway
extending through the guide cap; and (b) a one-way valve allowing
anesthetic to be introduced through the guide cap passageway and
guide during insertion of the guide into the patient's mouth and
hypopharynx, but substantially preventing the escape of air/oxygen
through the guide during resuscitation of the patient, said guide
cap being removable from the guide to allow insertion of the
endotracheal tube through the guide.
2. The apparatus of claim 1 wherein the guide cap further comprises
a luer connector for removably securing a syringe to the guide cap
passageway.
3. The apparatus of claim 1 wherein the one-way valve comprises a
duck-bill valve.
4. The apparatus of claim 1 wherein the guide comprises a J- shaped
tubular member.
5. The apparatus of claim 4 wherein the guide further comprises a
annular ring within the proximal end of the guide forming a seal
around the endotracheal tube.
6. An apparatus for resuscitating a patient and guiding insertion
of an endotracheal tube into the patient's trachea, said apparatus
comprising: a face mask to cover a patient's mouth, the face mask
having a face mask port and a ventilation port allowing a flow of
air/oxygen into the face mask to resuscitate the patient; a guide
removably extending through the face mask port having a distal
portion for insertion into a patient's mouth and hypopharynx to
direct insertion of an endotracheal tube into the patient's
trachea; a fiber optic probe insertable through an endotracheal
tube; and a stabilizer removably attachable to the fiber optic
probe, said stabilizer having dimensions sufficiently large to push
the endotracheal tube forward as the fiber optic probe is advanced
along the guide and into the patient's trachea.
7. The apparatus of claim 6 further comprising an endotracheal tube
cap removably attachable to proximal end of the endotracheal tube
having a passageway to receive the fiber optic probe.
8. The apparatus of claim 7 wherein the endotracheal tube cap has
dimensions sufficiently small to fit through the face mask
port.
9. The apparatus of claim 7 wherein the passageway of the
endotracheal tube cap has an inside diameter smaller than the
stabilizer.
10. The apparatus of claim 6 wherein the stabilizer has dimensions
sufficiently small to fit through the face mask port.
11. The apparatus of claim 6 wherein the stabilizer comprises a
flexible tube having a C-shaped cross-section.
12. The apparatus of claim 6 wherein the fiber optic probe is an
endoscope probe and wherein said stabilizer can be attached to any
point along the length of the endoscope probe.
13. A method for resuscitating a patient and guiding insertion of
an endotracheal tube into the patient's trachea comprising: placing
a face mask over a patient's mouth, the face mask having a
removable guide extending posteriorly from the face mask allowing
insertion of an endotracheal tube through the face mask and along
the guide into the patient's mouth and hypopharynx, the face mask
further having a ventilation port allowing a flow of air/oxygen
into the face mask; resuscitating the patient by supplying a flow
of air/oxygen through the ventilation port into the face mask and
patient's airway; attaching a stabilizer at a desired position on a
fiber optic probe; inserting the fiber optic probe into an
endotracheal tube until the stabilizer abuts the proximal end of
the endotracheal tube; advancing the fiber optic probe so that the
endotracheal tube advances along the guide and into the patient's
trachea; removing the face mask over the proximal end of the
endotracheal tube while leaving the endotracheal tube and fiber
optic probe in place within the patient's trachea; removing the
fiber optic probe from the endotracheal tube; and ventilating the
patient through the endotracheal tube.
14. The method of claim 13 wherein the stabilizer is attached to
the fiber optic probe at a location so that the distal tip of the
fiber optic probe extends beyond the distal tip of the endotracheal
tube.
15. The method of claim 13 further comprising the steps of:
attaching a removable cap to the proximal end of the endotracheal
tube prior to insertion of the fiber optic probe, said cap having a
passageway to receive the fiber optic probe with an inside diameter
larger than the stabilizer; and removing the cap from the
endotracheal after the fiber optic probe is removed from the
endotracheal tube and prior to ventilating the patient through the
endotracheal tube.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of the
Applicant's co-pending U.S. patent application Ser. No. 09/411,610,
filed on Oct. 1, 1999, which is a continuation-in-part of U.S.
patent application Ser. No. 08/974,864, filed on Nov. 20, 1997, now
U.S. Pat. No. 5,964,217, issued on Oct. 12, 1999, which is a
continuation of U.S. patent application Ser. No. 08/607,332, filed
on Feb. 26, 1996, now U.S. Pat. No. 5,694,929, issued on Dec. 9,
1997.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to the field of
respiratory devices and methods. More specifically, the present
invention discloses a method and apparatus for guiding insertion of
an endotracheal tube while the patient continues to receive
cardiopulmonary resuscitation.
[0004] 2. Statement of the Problem
[0005] In emergency situations involving cardiopulmonary patients
or other patients with compromised or arrested breathing, an oral
airway is first inserted into the patient's mouth. A face mask is
then placed over the patient's mouth and nose. The face mask is
connected to an inflatable bag to maintain at least minimal oxygen
flow to the lungs in the short term. This process is sometimes
referred to as "bagging" the patient. It is suitable for initially
stabilizing the patient. In order to breathe more effectively for
the patient during cardiopulmonary resuscitation, and to prevent
aspiration of stomach contents, an endotracheal tube (or ET tube)
is placed into the trachea. Longer-term care usually requires
attaching the patient to a ventilator (e.g., by means of the
endotracheal tube). The transition from face mask to breathing
through the endotracheal tube can be dangerous if insertion of the
endotracheal tube takes too long, because the mask and oral airway
must be removed and the flow of air/oxygen is interrupted while the
endotracheal tube is inserted through the patient's mouth.
[0006] The typical conventional approach to making this transition
involves discontinuing resuscitation and completely removing the
mask and oral airway to expose the mouth. The physician inserts a
rigid laryngoscope blade into the patient's mouth to ensure that
the patient's airway is open, and then attempts to insert the
endotracheal tube through the patient's mouth and into the trachea
in the conventional manner. This may require a significant amount
of time, particularly if the patient is less than completely
cooperative and relaxed, or if the patient's airway has suffered
trauma, or the tongue has fallen back to close the airway. The
patient may not be breathing during this time, or may not be
breathing sufficiently to maintain adequate blood oxygen levels. If
the transition process takes more than a few seconds, the physician
must temporarily abandon the effort and return to resuscitation by
reinserting the oral airway and replacing the face mask. The
transition process may have to be repeated several times before the
endotracheal tube is successful installed. In addition, the speed
with which the transition process must be completed increases the
chances of a mistake being made or unnecessary injury to the
patient during the intubation procedure.
[0007] Endotracheal tubes are also used in semi-emergency
situations to ventilate patients with respiratory failure who may
be conscious or semi-conscious. The conventional approach requires
the patient to lie still while the physician inserts a rigid
laryngoscope blade into the patient's mouth and trachea. Delivery
of ventilation and/or oxygen is also interrupted during this
period. The endotracheal tube is then inserted into place while the
laryngoscope blade keeps the patient's airway open. Successful
intubation depends on the patient being cooperative and completely
relaxed, which unfortunately is often not the case. Even with a
cooperative patient, intubation is very uncomfortable and can cause
the patient to panic due to the difficulty in breathing during the
procedure. This procedure can also result in a choking or gagging
response that can cause the patient to regurgitate and aspirate
contents from the stomach. One conventional response to these
shortcomings has been to sedate the patient during intubation.
Tranquilizers make the patient more cooperative and less likely to
choke during intubation, but also tend to suppress the patient's
breathing and blood pressure. These side effects may be
unacceptable when dealing with a patient who already suffers from
shallow or irregular breathing or depressed blood pressure.
Therefore, a need exists for an improved device to guide insertion
of an endotracheal tube and ensure that the patient's airway is
open, and that also allows the patient to continue to receive
air/oxygen during the insertion process.
[0008] A wide variety of devices that combine face masks with tubes
for ventilation (e.g., endotracheal tubes) have been used in the
past, including the following:
1 Inventor Patent No. Issue Date Teves 5,348,000 Sep. 20, 1994 Don
Michael 5,339,808 Aug. 23, 1994 Jeshuran 5,197,463 Mar. 20, 1993
Northway-Meyer 4,848,331 Jul. 18, 1989 Kondur 4,580,556 Apr. 8,
1986 Donmichael 4,497,318 Feb. 5, 1985 Dryden 4,256,099 Mar. 17,
1981 Buttaravoli 3,809,079 May 7, 1974 Michael et al. 3,683,908
Aug. 15, 1972
[0009] Teves discloses a system for dispensing oxygen or anesthesia
via an interchangeable face mask and nasal catheter.
[0010] Don Michael discloses a endotracheal-esophageal intubation
device that includes a face mask (see, FIG. 2 of the Don Michael
patent).
[0011] Jeshuran shows an anesthesia mask 28 that is initially
placed over the patient's mouth and nose as shown in FIG. 7 of the
Jeshuran patent. A fiber optic 40 is inserted through an
endotracheal tube, and then through an opening in a two-piece core
84, 86, as shown in FIG. 9 of the Jeshuran patent. The fiber optic
40 is advanced into the trachea. The head 96 is then unscrewed and
the core segments 84, 86 are disassembled to allow the endotracheal
tube to be inserted through the mask, as shown in FIG. 2 of the
Jeshuran patent. The fiber optic 40 serves as a guide for insertion
of the endotracheal tube 46. The fiber optic 40 is then withdrawn
and the endotracheal tube cuff 136 is inflated, as shown in FIG. 8
of the Jeshuran patent. However, Jeshuran does not show a curved
guide to direct insertion of the fiber optic probe. The physician
is faced with the problem of navigating the fiber optic probe past
the patient's tongue and along the airway.
[0012] Northway-Meyer discloses a device for pulmonary ventilation
concurrent with fiber optic examination of the respiratory tract
and tracheal intubation. In particular, Northway-Meyer discloses a
face mask with a plurality of ports for ventilation and intubation
of the patient, and curved guide for advancing an endotracheal
tube.
[0013] Kondur discloses another example of an adapter 10 that
allows insertion of an endotracheal tube 40 through the face mask
50 and nose of the patient. Here again, no curved guide is
provided.
[0014] Donmichael discloses an esophageal obturator for blocking
aspiration of stomach fluids while the face mask is being used for
ventilating the lungs.
[0015] Dryden discloses a two-tube resuscitation system. One tube
is used to supply air to the trachea, while the other tube is used
for aspiration or administering medication.
[0016] Buttaravoli discloses a resuscitator having a face mask 11
with a curved tube 15 for supplying air to the patient's
airway.
[0017] Michael et al. disclose an apparatus for sealing a patient's
esophagus and providing artificial respiration. The apparatus
includes a mouth shield 14 and a curved main tube 10.
[0018] In addition, the prior art includes several references
involving intubating pharyngeal airways that have a curved central
tubular member, including the following:
2 Inventor Patent No. Issue Date Parker 5,339,805 Aug. 23, 1994
Augustine 5,203,320 Apr. 20, 1993 Berman 4,069,820 Jan. 24, 1978
Berman 4,068,658 Jan. 17, 1978 Berman 4,067,331 Jan. 10, 1978
Berman 4,054,135 Oct. 18, 1977
[0019] Parker discloses a curved guide for intubation of a
patient's trachea or suctioning of the hypopharynx or
esophagus.
[0020] Augustine discloses a tracheal intubation guide with a
curved forward end.
[0021] The Berman patents show an intubating pharyngeal airway
having a side access for passage of a tube. The side opening can be
expanded or closed by means of either a hinge on the opposite side
wall of the tube or by a cap.
[0022] 3. Solution to the Problem
[0023] None of the prior art references uncovered in the search
show a face mask that incorporates a port and a curved guide for
directing a fiber optic probe and endotracheal tube along the
patient's airway while resuscitation, cardiopulmonary
resuscitation, artificial mask breathing, or oxygenation continues.
After the distal end of the fiber optic probe has guided the
endotracheal tube past the larynx into the trachea, the fiber optic
probe is withdrawn and the endotracheal tube can be used to more
effectively "bag" the patient, or the patient can be connected to
an external ventilator.
[0024] This system allows the endotracheal tube to be inserted and
connected to a ventilator without interrupting resuscitation or
oxygenation of the patient via the face mask. In addition, the
curved guide greatly simplifies insertion of the fiber optic probe
and endotracheal tube by providing direction and maintaining an
open passageway past the patient's tongue and into the hypopharynx.
The flow of air/oxygen supplied by the resuscitation bag tends to
inflate the patient's mouth and airway, and thus also helps to
maintain a passageway and visualization for the fiber optic probe
and endotracheal tube.
SUMMARY OF THE INVENTION
[0025] This invention provides a method and apparatus for guiding
insertion of an endotracheal tube into a patient's trachea during
resuscitation by using a face mask and a curved guide. The guide is
inserted through a flexible port in the face mask and has a curved
distal portion that extends into the patient's mouth and
hypopharynx. The patient is initially resuscitated by supplying a
flow of air/oxygen through the mask. For example, a resuscitation
bag can be connected to a rotatable ventilation port on the face
mask. Alternatively, a resuscitation attachment with an air filter
and one-way valve can be removably attached to the ventilation port
of the face mask to enable a health care provider to directly
resuscitate the patient. An endotracheal tube is inserted over the
distal end of a fiber optic probe. Resuscitation, oxygenation, or
artificial ventilation continue without interruption while the
fiber optic probe and endotracheal tube are inserted through a
flexible port at the proximal end of the guide and then advanced
along the guide into the patient's airway. The direction of the
distal tip of the fiber optic probe can be controlled by the
physician. This allows the physician to carefully guide the fiber
optic probe and endotracheal tube to a position past the larynx
while resuscitation continues. The fiber optic probe is then
removed from within the endotracheal tube and the mask is removed
while leaving the endotracheal tube in place within the trachea.
The cuff on the endotracheal tube is inflated and a ventilator is
connected to the proximal end of the endotracheal tube to ventilate
the patient. Alternatively, the patient can be manually ventilated
by connecting a resuscitation bag to the proximal end of the
endotracheal tube.
[0026] A primary object of the present invention is to provide a
method and apparatus for guiding insertion of an endotracheal tube
that does not require interruption of the resuscitation
process.
[0027] Another object of the present invention is to provide a
method and apparatus for improving insertion of an endotracheal
tube by helping to keep the patient's airway open, and also
allowing the physician to guide the insertion process via the fiber
optic probe.
[0028] Another object of the present invention is to provide a
method and apparatus for instilling local anesthetic into the
patient's airway and suctioning excess secretions prior to
insertion of the endotracheal tube.
[0029] Another object of the present invention is to provide a
method and apparatus for guiding insertion of an endotracheal tube
that lessens the risk of injury and reduces patient discomfort.
[0030] Yet another object of the present invention is to provide a
device that enables the physician to instill anesthetic and/or
suction secretions from the patient's mouth and airway as the
device is inserted.
[0031] These and other advantages, features, and objects of the
present invention will be more readily understood in view of the
following detailed description and the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The present invention can be more readily understood in
conjunction with the accompanying drawings, in which:
[0033] FIG. 1 is a front perspective view of the face mask
assembly, including the port 23 and curved guide 25.
[0034] FIG. 2 is a rear perspective view of the mask assembly
corresponding to FIG. 1.
[0035] FIG. 3 is a cross-sectional view of the mask assembly
corresponding to FIG. 1.
[0036] FIG. 4 is a front view of the face mask port 23 showing the
stretchable opening 24 closed.
[0037] FIG. 5 is a cross-sectional view of the mouth and airway of
a patient after the mask 20 has been initially placed over the
patient's mouth and nose with the curved guide 25 extending into
the mouth, over the tongue 14, and into the hypopharynx 15.
[0038] FIG. 6 is a cross-sectional view of the mouth and airway of
the patient corresponding to FIG. 5 after the fiber optic probe 30
and endotracheal tube 40 have been inserted through the face mask
port 23 and advanced along the curved guide 25 to a position below
the larynx 18.
[0039] FIG. 7 is a front view of the mask port 23 corresponding to
FIG. 6 showing the fiber optic probe 30 and endotracheal tube 40 in
cross-section.
[0040] FIG. 8 is a cross-sectional view of the mouth and airway of
the patient corresponding to FIG. 5 after the fiber optic probe 30
has been removed from within the endotracheal tube 40.
[0041] FIG. 9 is a cross-sectional view of the mouth and airway of
the patient corresponding to FIG. 5 showing the face mask 20 being
removed while the endotracheal tube 40 remains in place.
[0042] FIG. 10 is a cross-sectional view of the mouth and airway of
the patient corresponding to FIG. 5 after the mask 20 has been
removed, the endotracheal tube cuff 44 has been inflated, and a
ventilator 50 has been connected to the endotracheal tube 40.
[0043] FIG. 11 is a cross-sectional view of the face mask 20 and
guide 25 in an alternative embodiment in which the curved guide 25
is configured as a oral airway that engages the posterior surface
of the mask 20 surrounding the face mask port 23.
[0044] FIG. 12 is a rear detail view of locking mechanism 21 used
to engage the curved guide 25 to the posterior surface of the mask
20.
[0045] FIG. 13 is a front perspective view of an alternative
embodiment of the face mask assembly.
[0046] FIG. 14 is a cross-sectional view of the mask assembly
corresponding to FIG. 13.
[0047] FIG. 15 is a side elevational view corresponding to FIGS. 13
and 14 showing the mask assembly 20 placed over the patient's mouth
and nose.
[0048] FIG. 16 is a front perspective view of a removable
resuscitation attachment 70 that can be connected to the
ventilation port 62 of the face mask assembly.
[0049] FIG. 17 is a side view of the resuscitation attachment 70
and flexible tubing 80.
[0050] FIG. 18 is a detail side view of an alternative embodiment
of the resuscitation attachment 70 in which the location of the
oxygen port 76 has been placed below the filter and one-way
valve.
[0051] FIG. 19 is an exploded perspective view of the guide cap
assembly.
[0052] FIG. 20 is a cross-sectional view of the guide cap assembly
corresponding to FIG. 19.
[0053] FIG. 21 is a cross-sectional view of the mouth and airway of
a patient after the mask 20 has been initially placed over the
patient's mouth and nose, and the curved guide 25 is being advanced
along the patient's airway while administering a local anesthetic
from the syringe 195.
[0054] FIG. 22 is a perspective view of the stabilizer 220 that can
attached to the fiber optic probe of an endoscope.
[0055] FIG. 23 is a perspective view of the endotracheal tube cap
230 that can be used in conjunction with a stabilizer 220.
[0056] FIG. 24 is a cross-sectional view of the mouth and airway of
a patient after the face mask 20 has been initially placed over the
patient's mouth and nose, and the stabilizer 220 and endotracheal
tube cap 230 have been used to advance the endotracheal tube 40 to
a position below the larynx 18.
DETAILED DESCRIPTION OF THE INVENTION
[0057] Turning to FIGS. 1 and 2, front and rear perspective views
of the present invention are illustrated. A corresponding
cross-sectional view is shown in FIG. 3. The face mask 20 is
adapted to fit over the patient's mouth and nose for resuscitation
of the patient 10 as shown in FIG. 5. The mask 20 has a low profile
and is made of an elastic material, such as rubber or flexible
plastic, to allow the mask to conform to the contours of the
patient's face and create a more air-tight seal around the mouth
and nose.
[0058] The face mask 20 includes a resealable port 23. In the
preferred embodiment, the face mask port 23 consists of a flexible,
elastic membrane having a stretchable opening 24 with dimensions
large enough to allow a curved guide 25 to pass through the face
mask port 23. For example, this elastic membrane can be made of
rubber with slot or hole forming an opening 24, as shown in FIG.
4.
[0059] As depicted in FIG. 5, the curved guide 25 can be readily
inserted through the face mask port 23 while maintaining a
substantially air-tight seal around the guide 25 to prevent gas
from escaping from within the face mask 20. The guide 25 is
generally tubular and includes a resealable port 27 at its proximal
end. For example, the guide port 27 can be made of a flexible,
elastic membrane having a stretchable slot or opening 28 with
dimensions large enough to allow an endotracheal tube to pass
through the guide port 27. The guide 25 extends posteriorly through
the face mask 20 and has a curved distal portion that is inserted
into the patient's mouth and hypopharynx 15 as the face mask 20 is
placed over the patient's mouth. The distal portion of the curved
guide 25 is generally J-shaped to follow the profile of a typical
patient's airway through the mouth, over the tongue 14, and into
the hypopharynx 15 just above the opening to the trachea 16. The
guide 25 is shaped to prevent the patient's tongue 14 and
collapsible pharynx from obstructing access to the trachea 16,
while also defining a channel for later insertion of an
endotracheal tube. The guide 25 is typically made of plastic with
sufficient strength and rigidity to keep the patient's teeth apart
and prevent the patient from biting down on the endotracheal tube.
The face mask port 23 allows the guide 25 to slide relative to the
face mask 20, and also allows a limited range of rotation of the
guide 25. This flexibility allows the guide 25 to accommodate a
wide range of patient sizes and conditions.
[0060] In the preferred embodiment, the guide 25 is equipped with
small tube 29 bonded to the exterior of the guide 25 that extends
along the length of the guide 25 to its distal end. This tube 29
can be used to suction secretions from the patient's mouth and
airway as the guide 25 is advanced. Alternatively a syringe 55
containing a local anesthetic (e.g., lidocaine or xylocaine) can be
connected to the proximal end of the tube 29 to squirt anesthetic
as the guide 25 is insert through the patient's mouth and into the
hypopharynx 15, as illustrated in FIG. 5. If squirted with
sufficient force, the anesthetic can be carried as far as the
larynx 18 to deaden any discomfort associated with insertion of the
endotracheal tube 40. Alternatively, the physician can squirt
anesthetic directly down the main passageway of the guide 25. The
main passageway can also be used for suctioning secretions from the
patient's mouth and airway.
[0061] The patient is initially resuscitated by supplying a flow of
air/oxygen through the mask. For example, the flow of air can be
supplied by a resuscitation bag 22 attached to the mask 20 that is
manually squeezed periodically to simulate natural breathing.
However, other conventional air/oxygen supplies for resuscitation
could be substituted at the connector for the face mask 20. In the
preferred embodiment, the flow of oxygen/air from the resuscitation
bag 22 is directed around the exterior of the curved guide 25. This
tends to inflate the patient's mouth and airway, which distends the
collapsible tissues, and thereby makes visualization and insertion
of the endotracheal tube 40 easier.
[0062] After the patient's conditioned has been stabilized to some
degree during initial resuscitation, an endotracheal tube 40 is
inserted over a fiber optic probe 30. The fiber optic probe 30 and
endotracheal tube 40 are then inserted through the guide port 27
and along the guide 25 to a position within the trachea 16 past the
larynx 18 while resuscitation continues, as illustrated in FIG. 6.
The opening 28 in the flexible membrane stretches to allow the
endotracheal tube 40 and fiber optic probe 30 to pass through the
guide port 27, but maintains a sufficiently tight fit around the
endotracheal tube 40 to prevent the escape of gas from within the
mask 20, as shown in the front view of the face mask provided in
FIG. 7.
[0063] The fiber optic probe 30 allows the physician to view within
the patient's mouth and trachea 16 during insertion. The physician
can also remotely manipulate the direction of the probe tip 32 to
control the direction of the fiber optic probe 30. This minimizes
patient discomfort and risk of injury to the patient. The small
size of the fiber optic probe 30 also allows the physician to
thread the fiber optic probe 30 through relatively constricted
areas within the airway, such as the larynx 18. Most importantly,
the fiber optic probe 30 and endotracheal tube 40 do not interfere
with ongoing resuscitation of the patient.
[0064] The distal end 46 of the endotracheal tube 40 can beveled as
illustrated most clearly in FIG. 6. Experience has shown that
injury to the larynx 18 can be reduced by spinning the endotracheal
tube 40 as it is advanced. The beveled end tends to keep the
endotracheal tube 40 centered as it is passes through the vocal
cords. Injury to the lining of the mouth and trachea can be reduced
by using an endotracheal tube 40 made of a material having a low
coefficient of friction, such as silicone. Bivona Medical
Technologies of Gary, Ind., markets a line of endotracheal tubes
made of silicone with a helical reinforcing wire.
[0065] After the endotracheal tube 40 has been inserted, the fiber
optic probe 30 is removed from within the endotracheal tube 40
through the proximal end of the endotracheal tube 40, as depicted
in FIG. 8. The face mask 20 and guide 25 can then be removed while
leaving the endotracheal tube 40 in place within the trachea 16, as
shown in FIG. 9. The opening 28 in the flexible port 27 allows the
face mask 20 and guide 25 to be withdrawn over the connector 42 at
the proximal end of the endotracheal tube 40 with minimal effort
and dislocation of the endotracheal tube 40. The position of the
endotracheal tube 40 can be stabilized while the mask 20 is removed
by manually gripping the proximal end of the endotracheal tube 40
and gradually urging it through the port 27 as the mask 20 is
lifted from the patient's face. The physician can then reach under
the face mask 20 to grip the endotracheal tube 40 after the mask 20
has been lifted sufficiently to allow access.
[0066] Alternatively, the face mask 20 can be removed while leaving
the guide 25 in place to serve as an oral airway and to protect the
endotracheal tube 40 from being bitten by the patient's teeth.
After the face mask 20 has been removed, the endotracheal tube is
taped to the patient's face, or held in place by some other
suitable means for attachment.
[0067] The cuff 44 at the distal end 46 of the endotracheal tube 40
is then inflated through the port valve 45 to block the trachea 16.
An external ventilator 50 can be attached to the connector 42 at
the proximal end of the endotracheal tube 40, as shown in FIG. 10.
The patient can then be mechanically ventilated in the conventional
manner via the endotracheal tube 40. Alternatively, the patient can
be manually ventilated by attaching a resuscitation bag to the
connector 42 at the proximal end of the endotracheal tube.
[0068] It should be understood that the guide 25 and mask 20 can
have any number of possible embodiments. The embodiment shown in
the FIGS. 1-9 uses a guide 25 that extends through an elastic port
23 in the face mask 20. This allows a limited range of motion
between the guide 25 and mask 20 to make insertion of the guide
easier, but requires two elastic ports 23 and 28. Alternatively,
the guide 25 and mask 20 could be fabricated as two separate pieces
that engage one another, as illustrated in FIG. 11. This eliminates
the need for the guide port 27. In this embodiment, the guide 25 is
separately inserted into the mouth, similar to a conventional oral
airway. The mask 20 is then placed over the patient's mouth and
nose so that the proximal end of the guide 25 engages a
corresponding opening in the posterior face of the mask 20 to
provide a relatively continuous passageway for insertion of the
fiber optic probe 30 and endotracheal tube 40 through the face mask
port 23 and along the guide 25. FIG. 12 provides a rear detail view
of the locking mechanism 21 used to engage the guide 25 to the
posterior face of the mask 20. The guide 25 can be readily
disengaged by rotating it slightly relative to the face mask 20.
After the endotracheal tube 40 has been inserted, the mask 20 is
removed while leaving the guide 25 in place within the patient's
mouth. The guide 25 remains around the endotracheal tube 40 and
protects it from being bitten or crimped by the patient's
teeth.
[0069] The guide 25 can consist of a J-shaped tubular member as
shown in the drawings. Alternatively, the distal portion of the
guide 25 can have a U-shaped cross-section. The guide 25 can be
molded from a suitable plastic material having a relatively low
coefficient of friction to minimize irritation to the lining of
mouth and trachea and to minimize resistance to insertion of the
endotracheal tube 40 along the guide. Friction can be further
reduced by applying a slippery coating to both the exterior and
interior surfaces of the guide 25. A slippery coating can also be
applied to the endotracheal tube to minimize friction between the
endotracheal tube and the guide.
[0070] All of the components necessary to practice the present
invention can be readily packaged as a kit for use in emergency
rooms and intensive care units. The kit is sufficiently compact and
inexpensive that it can be stocked on resuscitation carts widely
used in hospitals, and carried in ambulances for use by emergency
medical technicians in the field. The fiber optic probe can be
operated using a battery-powered light source. The oxygen supply
for the hospital or ambulance can be connected to the face mask 20
for resuscitation or to provide a flow of gas to the ventilator 50.
The tube 29 extending along the guide 25 can also be connected to
the suction system provided by the hospital or ambulance, if
necessary.
[0071] Rotatable Ventilation Port. FIG. 13 is a front perspective
view of an alternative embodiment of the face mask assembly with a
rotating ventilation port. FIG. 14 shows a cross-sectional view of
the mask assembly corresponding to FIG. 13. FIG. 15 is a side
elevational view showing the mask assembly 20 placed over the
patient's mouth and nose.
[0072] In contrast, the embodiment of the present invention
illustrated in FIGS. 1-12 has a fixed ventilation port for
connecting a resuscitation bag 22 or other source of air/oxygen to
the face mask 20. This limitation may present a significant problem
in emergency situations in which only limited access to the patient
is available, or in which the patient cannot be readily moved.
Similar problems can also occur in a hospital setting, due to the
patient's position in bed, or surrounding medical equipment that
can limit access to the patient from one side or the other.
[0073] Returning to FIGS. 13-15, the mask assembly includes a
rotatable annular ventilation collar 60 with a ventilation port 62
that can be connected to a conventional respiration bag 22 or other
air/oxygen source to ventilate the patient. The ventilation collar
60 allows the ventilation port 62 to be freely rotated to any
desired orientation about the face mask port 23.
[0074] Air from the resuscitation bag 22 flows through the
ventilation port 62 and into the annular ventilation collar 60. It
then flows through a plurality of small ventilation holes 66 in the
mask 20 beneath the annular ventilation collar 60 into the
patient's mouth and nose. The resuscitation bag 22 is typically
used to initially resuscitate the patient, and to provide
short-term ventilation until the endotracheal tube is in place and
connected to a ventilator. After the patient has been intubated and
connected to the ventilator, the resuscitation bag 22 can be
removed. If needed, the resuscitation bag 22 can reconnected to the
ventilation port 62 to supplement the flow provided by the
ventilator.
[0075] In particular, the mask 20 includes a raised cylindrical
flange 63 that engages a corresponding flange 64 extending around
the base of the annular ventilation collar 60 to provide a
rotatable, but generally air-tight seal between the mask 20 and the
ventilation collar 60. A tubular member 67 extends upward from the
surface of the mask 20 beneath the ventilation collar 60, and
passes through the central opening in the annular ventilation
collar 60. An O-ring 65 provides a rotatable, air-tight seal
between the outer surface of the tubular member 67 and the
ventilation collar 60, and also serves to retain the ventilation
collar in place on the mask assembly 20.
[0076] A resealable face mask port 23 is provided at the upper
opening of the tubular member 67, so that a curved guide 25 can be
removably inserted through the face mask port 23 and into the
patient's mouth and hypopharynx 15, as illustrated in FIG. 5. When
the face mask port 23 is not in use (e.g., during initial
resuscitation of a patient using the resuscitation bag 22), the
face mask port 23 should remain sealed to prevent gas from escaping
from the face mask 20. For example, the face mask port 23 can be a
flexible membrane that has a stretchable opening to receive the
guide 25. When the guide 25 is not inserted through the face mask
port 23, the flexible membrane retracts to substantially seal the
opening and prevent gas from escaping from the face mask port 23,
as previously discussed. Alternatively, the face mask port 23 can
be equipped with a removable cap to seal the port with it is not in
use.
[0077] Resuscitation Attachment. FIG. 16 is a perspective view of a
removable resuscitation attachment 70 that can used in place of the
resuscitation bag 22 for mouth-to-mask resuscitation by the rescue
person. In a hospital setting, the first person responding to a
patient in need of resuscitation typically activates an alarm to
summon a resuscitation team, and then immediately begins
mouth-to-mouth resuscitation of the patient until the resuscitation
team arrives. To help minimize the risk of contamination, many
hospitals equip each hospital bed with a face mask having a
ventilation port for mouth-to-mask resuscitation. This type of face
mask is also commonly provided for use by police and firemen with
little medical training. When the resuscitation team arrives, this
face mask is generally replaced with a system consisting of a
second face mask, an oral airway, and a resuscitation bag. Since
the patient usually requires intubation, this second face mask must
be removed while an endotracheal tube is inserted into the
patient's airway and the patient is connected to a ventilator. Each
of these transitions entails an interruption in on-going
resuscitation efforts, which can be detrimental to the patient.
According to the American Heart Association, a period in excess of
30 seconds without breathing or circulation can cause irreversible
brain and heart damage
[0078] In addition, the most common types of face masks used for
initial resuscitation at the patient's bed do not include a guide
or oral airway to keep the patient's airway open. As a result,
initial efforts at manual resuscitation using the first face mask
may be partially or completely ineffective, until the resuscitation
team arrives and replaces the first face mask with a second face
mask and a separate airway device used to keep the patient's airway
open.
[0079] In contrast to the conventional approach practiced in many
hospitals, as described above, the present invention allows the
same face mask to be used throughout the entire process without
interrupting resuscitation. In addition, the present invention
includes a face mask with a curved guide that can be inserted into
the patient's airway to maintain patency during the first effort to
resuscitate the patient before the resuscitation team arrives.
[0080] Returning to FIG. 16, the resuscitation attachment 70 has an
output port 71 that can be removably connected to the ventilation
port 62 of the face mask 20. The healthcare provider administers
mouth-to-mask resuscitation to the patient via the resuscitation
attachment 70 and face mask 20.
[0081] The resuscitation attachment 70 includes an air filter 74
across the flow path between the input port 72 and output port 71,
to help prevent the exchange of contaminants between the healthcare
provider and patient. A one-way valve 75 (e.g., a duckbill valve)
directs any backflow of air or contaminated fluids from the face
mask 20 to the exhaust port 73, and thereby serves to further
protect the healthcare provider from contaminants.
[0082] The healthcare provider can breathe directly into the input
port 72 of the resuscitation attachment 70. Alternatively, a length
of flexible tubing 80 can be connected to the resuscitation
attachment 70 by means of a connector 82 that can be plugged into
the input port 72 of the resuscitation attachment 70, as shown in
FIG. 17. In the preferred embodiment, the flexible tubing 80 is
approximately six inches in length and forms a helical coil for
easier storage. The proximal end of the flexible tubing 80 has a
mouthpiece 84 with an oval opening.
[0083] The resuscitation attachment 70 can also be equipped with an
oxygen port 76, as shown in FIG. 17, that can be connected by
tubing to a external oxygen source to supply supplemental oxygen to
the patient through the flow path, in addition to the mouth-to-mask
resuscitation provided by the healthcare provider. Each exhalation
by the healthcare provider then carries oxygen-enriched air through
the face mask 20 and into the patient's lungs. The oxygen port 76
can be closed with a removable cap 77 when the oxygen port 76 is
not in use. The internal passageway within the flexible tubing 80
and resuscitation attachment 70 upstream from the one-way valve 75
serve as a reservoir for accumulation of oxygen between each
exhalation by the healthcare provider.
[0084] FIG. 18 shows an alternative embodiment of the resuscitation
attachment 70 with the oxygen port 76 placed below the one-way
valve 75 and filter 74. In this embodiment, the internal passageway
within the resuscitation attachment 70 downstream from the one-way
valve 75 serves as a reservoir for accumulation of oxygen between
each exhalation by the healthcare provider. The one-way valve 75
helps to prevent oxygen from escaping during the remainder of the
resuscitation cycle. However, the exhalation port 73 prevents the
build-up of excessive pressure that might be injurious to the
patient's lungs.
[0085] Removable Guide Cap. FIGS. 19-21 show a removable cap
assembly that can be used to seal the proximal end of the tubular
guide 25 in place of the guide port 27 shown for example in FIGS.
1, 4, and 7. As shown in the exploded perspective view of the cap
assembly provided in FIG. 19, the guide cap 191 has an outside
diameter dimensioned to seat into the proximal opening of the guide
25. A central passageway extends through the guide cap 191. As
shown in the cross-sectional view provided in FIG. 20, a luer
connector 192 with a one-way valve 193 (e.g., a duck-bill valve) is
permanently attached to the guide cap 191 so that air or fluid can
only flow down the passageway of the guide cap 191, but not up.
Thus, the one-way valve 193 serves to prevent air/oxygen from
escaping from within the face mask 20 during initial
resuscitation.
[0086] As illustrated in the cross-sectional view provided in FIG.
21, a syringe 195 containing anesthetic can be secured to the luer
connector 192 on the guide cap 191. As the guide 25 is advanced
into the patient's mouth and hypopharynx, the healthcare provider
squirts anesthetic from the syringe 195, through the one-way valve
193 and guide 25 to lessen discomfort.
[0087] After the guide 25 has been advanced into position, the
guide cap 191 is removed from the guide 25 to allow insertion of
the endotracheal tube 40 through the guide 25, as previously
discussed. An annular ring 127 within the proximal end of the guide
25 forms a loose seal around the endotracheal tube 40 to help
prevent air/oxygen from escaping as the endotracheal tube 40 is
being inserted.
[0088] Fiber Optic Probe Stabilizer. FIGS. 22-24 show another
embodiment in which a stabilizer 220 is attached to the endoscope
probe 30 and then used to advance the endotracheal tube 40 along
the guide 25 and into the patient's trachea. In the preferred
embodiment, the stabilizer 220 is a flexible plastic tube having a
C-shaped cross-section, as shown in FIG. 22, that can be readily
clipped over the fiber optic probe 30 at any desired location along
its length.
[0089] The inside diameter of the stabilizer 220 should be selected
to provide a snug, frictional fit against the exterior of the fiber
optic probe 30 so that the stabilizer 220 will not readily slide
after it has been attached to the fiber optic probe 30. The
stabilizer 220 can also be readily removed from the endoscope probe
30 by the healthcare provider for cleaning or to adjust its
location on the probe 30. The stabilizer 220 should have outside
dimensions sufficiently large to push the endotracheal tube forward
as the fiber optic probe 30 is advanced by the healthcare provider,
and sufficiently small to fit through the face mask port.
[0090] The proximal end of the endotracheal tube 40 can be fitted
with a removable cap 230 shown in FIG. 23. This cap 230 has outside
dimensions selected so that it can be inserted snugly into the
proximal opening of the endotracheal tube 40 and yet is
sufficiently small to fit through the face mask port, if
necessary.
[0091] A central passageway extends axially through the cap 230 to
receive the fiber optic probe 30. The fiber optic probe 30 passes
freely through the cap 230. However, the cap passageway has an
inside diameter smaller than the stabilizer 220, so that the
stabilizer 220 will abut and push against the proximal end of the
endotracheal tube 40 as the fiber optic probe 30 is advanced by the
healthcare provider.
[0092] In practice, this embodiment of the present invention
typically uses the following sequence of steps. First, the face
mask 20 is placed over the patient's mouth and the patient is
initially resuscitated by a flow of air/oxygen delivered through
the face mask ventilation port. With the guide cap 191 sealing the
proximal end of the guide 25, the distal portion of the guide 25 is
advanced by the healthcare provider into the patient's mouth and
hypopharynx, as previously discussed. If necessary, a syringe 195
can be attached to the guide cap 191 to spray anesthetic down the
guide 25 and into the patient's airway to less discomfort.
[0093] The stabilizer 220 is attached at a desired position on a
fiber optic probe 30 of the endoscope. The fiber optic probe 30 is
then inserted into the proximal end of the endotracheal tube 40
until the stabilizer 220 abuts the proximal end of the endotracheal
tube 40. The location of the stabilizer 220 on the fiber optic
probe 30 is normally selected so that the distal tip of the fiber
optic probe 30 will extend slightly beyond the distal tip 46 of the
endotracheal tube 40.
[0094] Optionally, a removable endotracheal tube cap 230 is
attached to the proximal end of the endotracheal tube 40 prior to
insertion of the fiber optic probe 30 so that the stabilizer 220
will push against this cap 230 as the healthcare provider advances
the fiber optic probe 30. In this variation, the fiber optic probe
30 is inserted through both the endotracheal tube cap 230 and the
endotracheal tube 40.
[0095] The guide cap 191 and syringe 195 are removed from the guide
25, and the assembly consisting of the endotracheal tube 40, fiber
optic probe 30 and stabilizer 220 is inserted through the proximal
end of the guide 25. The healthcare provider then pushes forward on
the fiber optic probe 30 to advance the endotracheal tube 40 and
the fiber optic probe 30 along the guide 25 and into the patient's
trachea 16 as shown in FIG. 24. If the fiber optic probe 30 is part
of a conventional endoscope, the healthcare provider can view
through the endoscope probe 30 and manipulate the controls on the
endoscope housing 31 to navigate the distal portion of the
endotracheal tube 40 through the larynx and into the pharynx. Many
conventional endoscopes include a suction channel extending the
length of the fiber optic probe to its distal tip. This feature can
be used to suction mucus or other secretions from the patient's
airway as the endoscope/endotracheal tube assembly is inserted.
[0096] After the endotracheal tube 40 has been moved into position
with its distal end in the trachea, the face mask 20 is removed
over the proximal end of the endotracheal tube 40 while leaving the
endotracheal tube 40 and fiber optic probe 30 in place. More
specifically, the face mask 20 and guide 25 can either be removed
together, or the face mask 20 can be remove first followed by the
guide 25.
[0097] Before removing the face mask 20 and guide 25, the
healthcare provider may wish to slide the stabilizer 220 a few
centimeters toward the distal end of the fiber optic probe 30. This
allows the endoscope to be pulled back relative to the endotracheal
tube 40, so that the distal tip of the endoscope is located within
the distal end of the endotracheal tube 40 and offers a view of
both the endotracheal tube's distal tip and the patient's trachea.
This enables the healthcare provider to monitor the position of the
endotracheal tube 40 relative to the trachea as the face mask 20
and guide 25 are removed, as described above.
[0098] The fiber optic probe 30 is then withdrawn from within the
endotracheal tube 40 and the endotracheal tube cap 230 is removed
if one is present. Finally, the patient can be ventilated via a
conventional ventilator connected to the endotracheal tube 40.
[0099] The above disclosure sets forth a number of embodiments of
the present invention. Other arrangements or embodiments, not
precisely set forth, could be practiced under the teachings of the
present invention and as set forth in the following claims.
* * * * *