Note: Descriptions are shown in the official language in which they were submitted.
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WO 99/32182 PCT/US97/23487
MOUTHPIECE FOR ENDOTRACHEAL TUBE
BACKGROUND OF THE INVENTION
1. FIELD OF THE INVENTION
The present invention relates to endotracheal tubes
and their associated support structures. The
invention relates specifically to an endotracheal
system having a contoured mouthpiece to be fitted
between a patient's teeth and allowing the passage of
an endotracheal tube. The invention also provides a
medication injection line that allows precise dosages
of medication to be delivered directly to the lungs.
2. DESCRIPTION OF THE PRIOR ART
Conventional systems for tracheal. intubation are
employed routinely by health care professionals in
hospital settings. The function of tracheal
intubation is to provide mechanical assistance to
patients for their secure airway and respiration
functions. If mechanical assistance is not provided,
the patient will exhibit respiratory distress. The
situation could progress to respiratory arrest and
even death. Consequently, mechanical assistance is
imperative to keeping the airways open.
Such mechanical assistance is effected by an
endotracheal tube originating from outside of the
patient and extending into the patient's trachea. The
endotracheal tube is inserted in the mouth and passed
through the larynx into the trachea. The endotracheal
tube is typically provided with an inflatable cuff
when a sealed airway is required for mechanical
ventilation. Once inflated, the cuff fills the space
between the outside of the tube and the trachea. The
exterior end of the tube is then coupled to a
ventilation source for the administration of oxygen,
air, or other gases.
It is a conventional practice to secure medical
tubes which are to be disposed externally of a patient
with an adhesive tape which is wrapped around the
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2
tubing and extended therefrom so that it may be
adhered to the skin of the patient. However, such an
approach is often uncomfortable to the patient.
Furthermore, removal of the adhesive tape often causes
irritation and infection, in severe cases, to the area
where the tape was secured.
Frequently, the tape becomes loose from movement of
the patient's head and allows the tube to migrate
upward, sideways, or drift downward, thereby
appreciably reducing the effectiveness of the tube for
providing the needed airflow. More importantly, the
tube may descend into one of the bronchi and cause one
of the patient's lungs to collapse. It is therefore
essential that the medical attendant be continually
vigilant in inspecting the adhesive tape and insuring
that the endotracheal tube remains immovably secured.
This task can often prove difficult to the medical
attendant who must oversee a great number of patients.
Often when a patient has suffered a heart attack, it
is necessary to perform an intubation procedure while
the patient is unconscious. As the patient starts to
regain consciousness, the endotracheal tube can
sometimes cause undue stimulation of the
parasympathetic nervous system, which may slow the
heart rate. In addition, the patient's gag reflex is
increased which places stress on the heart. The use
of a bite block can often reduce this phenomenon.
In many situations where an endotracheal tube is
used, it is also necessary to introduce medication to
the patient. In hospital settings, where
environmental conditions are excellent, intravenous
injections are performed routinely for the most rapid
administration of life-saving drugs even when a
patient is being assisted by an endotracheal tube. In
pre-hospital settings, endotracheal tubes are also
employed by paramedics or the like. Similar to the
hospital setting, the preferred method of
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WO 99/32182 PCT/US97/Z3487
3
administering drugs is intravenously, although
alternative methods are being sampled. One such
method is intratracheal drug administration.
Intratracheal drug administration allows the drug to
enter the blood stream immediately due to the direct
relation between the lungs and the heart.
While the prior art discloses numerous types of
endotracheal tubes and associated support structures,
most are suited only for the evacuation of fluids and
local anesthesia. For example, U.S. Patent No.
5,042,477 issued on Aug. 27, 1991, to Lewis discloses
a medical tube holder for securing endotracheal tubes
and the like. The tube holder has an elongated tube
made of elastomeric, flexible material with a hollow
interior and a slit formed transversely to a
longitudinal axis of the tubing at the middle portion
of the tubing. A securing strap is threaded through
the tubing with the middle portion of the strap
extending through the slit to form a loop through
which the medical tube is inserted. The flexible
material is brought around the patient' s body and tied
together in order to secure the tube relative to the
patient's body.
U.5. Patent No. 5,146,916 issued on Sep. 15, 1992,
to Catalani discloses an endotracheal tube equipped
for delivering a drug externally of the tube. The
endotracheal tube includes a tube body having proximal
and distal ends, and at least one flexible irrigation
cannula extending along the endotracheal tube's body
to its distal end. An irrigation diffuser is attached
to the irrigation cannula for spraying a drug
externally. The endotracheal tube is particularly
useful for the repeated administration of local
anesthetics.
U.S. Patent No. 5,174,284 issued on Dec. 29, 1992,
to Jackson discloses a bite block to prevent a patient
from biting into an instrument inserted through the
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4
mouth during a medical procedure. The bite block
includes a sloping channel against which the patient
is to bite. As the patient bites on the block, it
becomes more firmly seated in the mouth and the
patient's tongue is further depressed.
U.S. Patent No. 5,181,508 issued on Jan. 26, 1993,
to Poole, Jr. discloses a drug administering
endotracheal respiration system. The system is useful
in administering drugs into the lungs of a patient
while maintaining the flow of life supporting gases
into the lungs via a ventilation apparatus.
U.5. Patent No. 5,237,988 issued on Aug. 24, 1993,
to McNeese discloses a device for immovably securing
an endotracheal tube after it has been inserted into
the patient's airway. A pair of supports are
removably fastened to the inlet of the tube, while a
belt is secured to the supports and snugly positioned
around the neck of the patient. An adhesive strip is
positioned on the belt for adhering to the back of the
patient's neck.
U.S. Patent No. 5,309,905 issued on May 10, 1994 to
Teves discloses a connector for endotracheal tubes.
The connector is particularly useful for use with
tubes which include an integral auxiliary lumen. The
connector is tubular in shape and includes a tubular
mounting member extending from its proximal end, and
a tubular mounting member extending from its distal
end for connecting the endotracheal tube to an
auxiliary source. A bore extends from the proximal to
the distal end of the connector and includes an
auxiliary mounting member at each end for connecting
the auxiliary lumen.
U.5. Patent No. 5, 311, 864 issued on May 17, 1994, to
Huerta discloses an apparatus for safe and effective
evacuation of fluids or t.o dispense medication to a
patient undergoing breathing assistance. The
apparatus includes an evacuation sheath, a balloon
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cuff lumen, and an optional lumen with a reinforced
balloon cuff upper end which promotes uninterrupted
breathing assistance and balloon cuff operations. The
invention may also be provided with an auxiliary tracheal
5 plate for sealing a tracheal incision.
U.S. Patent No. 5,402,776 :issued on Apr. 4, 1995, to
Islava discloses an endotracheal tube holder including a
face plate assembly which is attached to a patient's head
by an adjustable headband. The face plate assembly
includes a plate adapted to be positioned over the
patient' s mouth and includes an opening for access to the
patient's mouth. A bite block is secured to the inner
surface of the face plate in order to keep the patient's
mouth open.
United Kingdom Patent No. 2, 164, 565 issued on Mar. 26,
1986, to Collins, et al. discloses an endotracheal tube
assembly having an inflatable cuff . The cuff is inflated
via an inflation line partially disposed within the wall
of the endotracheal tube.
European Patent Application No. 200,470 published on
Nov. 5, 1986, to Waller discloses a support for a
tracheotomy or endotracheal tube. The support includes
a band of flexible material which wraps around the
patient's head. The band includes an aperture portion
through which an endotracheal tube may be passed. The
support may also be provided with a base member which
abuts a patient's throat when a tracheotomy is performed.
None of the above inventions and patents, taken either
singly or in combination, is seen to describe the instant
invention as claimed.
STJN~iARY OF THE INVENTION
The present invention is a mouthpiece for an
endotracheal tube. The endotracheal tube includes a bite
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6
block of unitary construction having a proximal surface,
a distal surface, and a central aperture of a
predetermined diameter for receiving an endotracheal tube
therethrough. The endoctracheal tube has at least two
arresting elements. Each of the arresting elements
includes a base portion positionable in a parallel manner
along the proximal surface of the bite block. An
upstanding leg is integrally attached at one end to the
base portion. There is a means for pivotally coupling
each of the arresting elements to the bite block. A
frictional engagement means is associated with each of the
arresting elements for restricting movement of the
endotracheal tube. A means is provided for detachably
engaging each of the arresting elements to the bite block.
Also part of the invention is a mouthpiece for an
endotracheal tube . The mouthpiece includes a bite block
of unitary construction having a proximal surface, a
distal surface, and a central aperture of a predetermined
diameter for receiving an endotracheal tube therethrough.
A tubular extension originates from the proximal surface
and extends perpendicularly therefrom. The tubular
extension has an inner diameter identical to the diameter
of the central aperture contained in the bite block and
an outer diameter substantially less than the distance
from the outermost point on the proximal surface of the
bite block to the central aperture . The mouthpiece has
at least two arresting elements, and means for pivotally
coupling each of the arresting elements to the bite block.
A frictional engagement means is associated with each of
the arresting elements for restricting movement of the
endotracheal tube.
Also part of the invention is an endotracheal system.
The system includes an endotracheal tube. The
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7
endotracheal tube has a proximal end and a distal end.
An exit port is integrally attached to the distal end.
The endotracheal tube also has an inner diameter and an
outer diameter. A wall is defined by the area formed
between the inner and outer diameters. An inflatable
balloon surrounds the wall at the distal end of the
endotracheal tube. The endotracheal tube has means for
inflating the balloon. A first lumen originates external
of the endotracheal tube and enters the wall through a
first entry point proximate the proximal end of the
endotracheal tube. The first lumen extends through the
endotracheal tube and terminates at the exit port for
delivering medication out of the endotracheal tube. A
second lumen originates external of the endotracheal tube
and enters the wall through a second entry point proximate
the proximal end of the endotracheal tube. The second
lumen extends through the endotracheal tube and exists in
the balloon. A membrane is integrally connected to the
exit port of the first lumen. The membrane contains a
plurality of micropores dimensioned for atomizing the
medication. The endotracheal system also has a
mouthpiece. The mouthpiece includes a bite block of
unitary construction having a proximal surface, a distal
surface, and a central aperture of a predetermined
diameter for receiving an endotracheal tube therethrough.
The mouthpiece has at least two arresting elements. Each
of the arresting elements includes a base portion
positionable in a parallel manner along the proximal
surface of the bite block. An upstanding leg is
integrally attached at one end to the base portion. The
mouthpiece has means for pivotally coupling each of the
arresting elements to the bite block. A frictional
engagement means is associated with each of the arresting
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8
elements for restricting movement of the endotracheal
tube . The mouthpiece has means for detachably engaging
the arresting elements to the bite block. Means are also
provided for securing the endotracheal system to a
patient.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a partially fragmented environmental view of
an endotracheal system of the present invention.
Fig. 2 is a sectional view detailing the mouthpiece of
the present invention.
Fig. 3 is a side elevational view of an endotracheal
system according to the present invention.
Fig. 4 is a sectional view of an alternative embodiment
of the mouthpiece utilizing a flexible material to
interconnect the bite block and the arresting element.
Fig. 5 is a sectional view of an alternative embodiment
of the mouthpiece of the present invention.
Fig. 6 is a partially fragmented side elevational view
of an alternative embodiment of the present invention
capable of delivering medication in a spray form.
Similar reference characters denote corresponding
features consistently throughout the attached drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
With reference to the drawings and initially to Fig. 1,
there is provided a mouthpiece 10 for an endotracheal tube
12. The mouthpiece includes a bite block 14 which has a
proximal surface 18 and a distal surface 20. The bite
block 14 also contains a central aperture through which
the endotracheal tube 12 is inserted. The central
aperture is of a predetermined diameter for receiving an
endotracheal tube. The mouthpiece 10 includes a bite
block 14 and a plurality of arresting elements 16 attached
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9
to the bite block 14. The arresting elements 16 are used
to restrict motion of the endotracheal tube 12.
Each arresting element contains a frictional pad for
restricting the motion of the endotracheal tube. Each
arresting element is also capable of detachably engaging
the bite block. When an arresting element engages the
bite block, it is locked in a position where the
frictional pad is in contact with the endotracheal tube,
thereby restricting motion of the tube. When the
arresting element is disengaged from the bite block, the
frictional pad is no longer in contact with the
endotracheal tube and the tube is somewhat free to move
within the central aperture of the bite block.
The bite block is designed to withstand the forces
capable of being exerted by a patient's jaw. This in turn
prevents a trauma patient from accidentally biting down
on the endotracheal tube and depriving himself of life
saving gases . The bite block may also be provided with
an external layer of resilient material for the patient
to comfortably bite into, while still having a rigid inner
layer which protects the endotracheal tube.
The bite block 14 is designed to fit between a
patient's teeth 30. In order to prevent a patient from
moving their jaw and accidentally biting on the
endotracheal tube 12, the bite block 14 should be of a
length sufficiently greater than the forward distance
which an average patient's jaw can travel. It is
preferred that the bite block 14 be made of a clear
material in order to facilitate reading the measurements
inscribed on the endotracheal tube 12.
The bite block 14 may be constructed of any material
which is capable of withstanding the forces which might
be applied upon it by a patient's jaw. The bite block 14
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may also have a variety of cross-sectional areas, such as
square or rectangular, so long as the patient is capable
of biting on the exterior.
The mouthpiece is provided with means to secure it to
5 the patient. V~lith the mouthpiece secured, the
endotracheal tube is incapable of being accidentally
removed from the patient's mouth or inserted further into
the trachea. This requires less supervision from
attending health care personnel to assure that the
10 endotracheal tube does not exit the patient's trachea and
damage the vocal cords or descend into one of the
patient's bronchi. In one embodiment of the invention,
the mouthpiece is secured to the patient by using
umbilical tape. The umbilical tape is secured to a first
arresting element, passed behind the patient's head, and
secured to a second arresting element.
A number of arresting elements 16 are attached to the
bite block 14. As seen more particularly with reference
to Fig. 2, each arresting element 16 has a base portion
34, an upstanding leg 40, and a shoulder 38. Each
arresting element 16 is coupled to the bite block 14. The
embodiment of the mouthpiece 10 illustrated Fig. 2
incorporates a hinge 44 as the means for coupling each of
the arresting elements 16 to the bite block 14. The hinge
44 provides a pivotable connection between the arresting
elements 16 and the bite block 14 as illustrated by the
phantom lines.
A fitted extension 36 originates from the base portion
34 of the arresting element 16 and extends in a
perpendicular manner. A mating recess is provided on the
proximal surface 18 of the bite block 14 for receiving the
fitted extension 36. The arresting element 16 may be
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11
pivoted until it engages the mating recess. Once engaged,
a predetermined force is required to disengage the
arresting element 16. Each arresting element 16 includes
a resilient friction pad 42 capable of contacting the
endotracheal tube 12. When the arresting elements 16 are
engaged with the bite block 14, the friction pads 42 are
placed in snug contact with the endotracheal tube 12 . The
combined force placed on the endotracheal tube 12 by all
of the friction pads 42 is sufficient for keeping the
endotracheal tube 12 in the desired stationary position.
In operation, a health care attendant would first
disengage the arresting elements 16 from the bite block
14 and insert the endotracheal tube 12 through the
aperture of the bite block 14. The endotracheal tube 12
is then inserted through the patient's oral cavity 26 and
into the trachea 28 as illustrated in Fig. 1. As the
endotracheal tube 12 is further inserted into the trachea
28, the mouthpiece 10 may be continually adjusted to
compensate so that it remains within contact of the
patient's teeth 30. Next, the arresting elements 16 are
pivoted to engage the bite black 14 so that the friction
pads 42 are in contact with the endotracheal tube 12, thus
preventing accidental movement thereof. As seen in Fig.
1, umbilical tape 48 or other means, such as a string or
cord, may be provided to secure the mouthpiece 10 to the
patient's head 24. Traditionally, adhesive tape is used
to secure the endotracheal tube to a patient's face.
An endotracheal system is also provided. The system
includes an endotracheal tube having a proximal end and
a distal end. The distal end of the endotracheal tube
also includes an exit port . The endotracheal tube has a
wall which is defined by the area between its inner and
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12
outer diameters . A balloon is attached around the outer
surface of the endotracheal tube at the distal end. The
balloon is capable of being inflated by an external supply
of gas. It is also possible to deliver medication
directly into the patient's lungs via the endotracheal
tube.
The system also includes a mouthpiece which has a bite
block and at least two arresting elements coupled to the
bite block. The bite block has a proximal surface, a
distal surface, and a central aperture suitable for
receiving the endotracheal tube. Each of the arresting
elements is provided with a frictional pad for restricting
the motion of the endotracheal tube inserted through the
bite block. The arresting elements are capable of
engaging the bite block and being locked in a position to
effectuate the necessary friction on the endotracheal
tube.
In order to deliver medication directly to the
patient's lungs and to inflate the balloon, two lumens are
disposed within the wall of the endotracheal tube. The
first lumen is used to deliver medication and extends to
the exit port of the endotracheal tube . The second lumen
is used to inflate the balloan and extends to the area
near the distal end corresponding to the location of the
balloon. The lumens enter the wall of the endotracheal
tube through a first and second entry point near the
proximal end of the endotracheal tube.
Turning now to Fig. 3, there is provided an
endotracheal system 100 which incorporates a mouthpiece
112 and is capable of delivering medication directly into
the lungs of a patient. The endotracheal system 100
includes an endotracheal tube 110, a mouthpiece 112, a
connector 116 for attaching the endotracheal tube to an
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external gas supply (not shown) , and umbilical tape 114
or other means, such as a string or cord, for securing the
endotracheal system 100 to the patient.
The endotracheal tube 110 has a proximal end 118 and a
distal end 120. An exit port 122 is attached to the
distal end 120 of the endotracheal tube 110. The
endotracheal tube 110 has an inner diameter and an outer
diameter . The area between the inner and outer diameters
defines a wall. A balloon 130 is attached to the outer
surface of the endotracheal tube 110 at the distal end
120.
A first lumen 132 is provided for delivering medication
to the patient s lungs. The first lumen 132 has a
proximal end 136 and a distal end 138. The first lumen
132 is disposed within the wall of the endotracheal tube
110. The distal end 138 of the first lumen 132 extends
to the exit port 122 of the endotracheal tube 110. The
proximal end 136 of the first lumen 132 is external of the
patient and the endotracheal tube 110. A first entry
point is provided in the wall of the endotracheal tube 110
for the first lumen 132 to enter through. A syringe
permeable diaphragm assembly 180 is attached to the
proximal end 136 of the first lumen 132 so that medication
may be directed to the patient.
A second lumen 134 is provided for inflating the
balloon 130. The second lumen 134 is also disposed in the
wall of the endotracheal tube 110. The second lumen 134
has proximal end 148 and a distal end 150. The proximal
end 148 of the second lumen 134 originates external of the
patient and the endotracheal tube 110 while the distal end
148 of the second lumen 134 terminates in the balloon 130.
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A second entry point is provided in the wall of the
endotracheal tube 110 through which the second lumen 134
enters . An adapter 154 is attached at the proximal end
148 of the second lumen 134 for attaching a gas supply
(not shown) to inflate the balloon 130.
The mouthpiece 112 of the endotracheal system 100
includes a bite block 156 and a plurality of arresting
elements 164. The bite block 156 has a proximal surface
158, a distal surface 160, and a central aperture through
which the endotracheal tube 110 is inserted. Each of the
arresting elements 164 includes a base portion 166, an
upstanding leg 168, and a shoulder 170. The shoulder 170
of each arresting element 164 also includes a vertical
groove. A friction pad 178 is also attached to the
upstanding leg 168 of each arresting element 164 in order
to secure the endotracheal tube 110.
A connector 116 is also provided for attaching the
endotracheal tube 110 to an external gas supply (not
shown) . The connector 116 includes a first passageway 174
which functions as the main supply line to the
endotracheal tube 110. Auxiliary passageways 176 which
are smaller in diameter may also be provided in the
connector 116. The auxiliary passageways 176 may serve
numerous functions such as monitoring the level of carbon
dioxide being exhaled by the patient.
Umbilical tape 114 or other means, such as a string or
cord, may be used to secure the endotracheal system 100
to the patient as illustrated in Fig. 3. The umbilical
tape 114 would first be passed through the vertical groove
in the shoulder 170 of one of the arresting elements 164
and wrapped around the same shoulder 170 several times so
that a short portion and an long portion remain free. The
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long portion of the umbilical tape 114 is then passed
behind the head of the patient and wrapped in a similar
manner around the shoulder 170 of another arresting
element 164. Next, the long portion of the umbilical tape
5 114 is wrapped several times around the endotracheal tube
110 and releasably tied to the short portion. The long
portion of the umbilical tape 114 may then be wrapped
several times around the connector 116 in order to secure
the entire endotracheal system 100 to the patient.
10 Turning now to Fig. 4, there is shown an alternative
embodiment of a mouthpiece 200. The mouthpiece 200
contains a bite block 210 which has a proximal surface 212
and a distal surface 214. The bite block 210 contains a
central aperture through which an endotracheal tube 216
15 may be passed. The arresting elements 218 of this
particular embodiment are coupled to the bite block 210
by means of a band 230 of flexible material. Each
arresting element 218 includes a base portion 220, an
upstanding leg 222, and a shoulder 224. A fitted
extension 226 extends from the base portion 220 and is
capable of engaging a mating recess contained on the
proximal surface 212 of the bite block 210. A friction
pad 228 is attached to the upstanding leg 222 of each
arresting element 218. When the fitted extension 226 of
the arresting element 218 engages the mating recess of the
bite block 210, the friction pads 228 are pushed snugly
against the endotracheal tube 216.
Fig. 5 illustrates another embodiment of a mouthpiece
300. The mouthpiece 300 is shown to include a bite block
310 which has a proximal surface 312 and a distal surface
314 . The bite block 310 also contains a central aperture .
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16
A tubular extension 316 originates from the proximal
surface 312 of the bite block 310. The tubular extension
316 has an inner diameter identical to the diameter of the
central aperture. The outer diameter of the tubular
extension 316 is significantly less than that of the bite
block 310. An endotracheal tube 336 may be passed through
the central aperture of the bite block 310 and the inner
diameter of the tubular extension 316. The arresting
elements 322 of this particular embodiment are pivotally
coupled to the bite block 310 at the point of origination
of the tubular extension 316. Each arresting element 322
includes an arm 324 and a shoulder 326. A fitted friction
pad 328 is attached to the arm of each arresting elements
322. The tubular extension 316 contains a plurality of
mating bores for receiving each of the fitted friction
pads 328. When the fitted friction pad 328 of the
arresting element 322 engages the mating bore of the bite
block 310, the fitted friction pad 328 is pushed snugly
against the endotracheal tube 336.
In certain situations, it may be desirable to deliver
medication in a spray, or atomized, form to a patient.
Fig. 6 illustrates an embodiment of the endotracheal
system which facilitates this procedure. Fig. 6 shows the
distal portion of an endotracheal tube 400. A balloon 410
is attached to the periphery of the distal portion 400.
An exit port 412 is integrally attached to the distal end
400 of the endotracheal tube and extends therefrom. A
f first and second lumen 414 , 416 are disposed within the
wall of the endotracheal tube. The first lumen 414 is
used to deliver medication to the lungs while the second
lumen 416 is used to inflate the balloon 410. In order
to facilitate the delivery of medication in a spray form,
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the first lumen 414 is sealed by a membrane which contains
a plurality of micro pores 420. This embodiment is
particularly effective when the medication needs to be
repeatedly administered or when topical anesthetics are
necessary.
The preferred embodiments of the invention provide a
mouthpiece for an endotracheal system which prevents a
patient from biting down on the endotracheal tube. The
mouthpiece secures the endotracheal tube from
unintentional movement. The mauthpiece also has means for
delivering medication to a patient's lungs.
It is to be understood that the present invention is
not limited to the embodiments described above, but
encompasses any and all embodiments within the scope of
the following claims.
