U.S. patent number 3,848,605 [Application Number 05/353,243] was granted by the patent office on 1974-11-19 for endotracheal tube with improved inflation retention means.
This patent grant is currently assigned to American Hospital Supply Corporation. Invention is credited to Andrew Harautuneian, William H. Penny.
United States Patent |
3,848,605 |
Harautuneian , et
al. |
November 19, 1974 |
ENDOTRACHEAL TUBE WITH IMPROVED INFLATION RETENTION MEANS
Abstract
A dual-lumen endotracheal tube with a plastisol tracheal balloon
of limited stretchability and a highly stretchable latex pilot
balloon. These two balloons are connected through an inflation
lumen of the endotracheal tube. Injection of 10 to 15 cc. of air
into the double balloon system through a special check valve at the
pilot balloon expands the pilot balloon substantially more than the
tracheal balloon. The pilot balloon forms a high volume low
pressure air reservoir gently urging the plastisol tracheal balloon
outwardly against a patient's trachea.
Inventors: |
Harautuneian; Andrew (Westlake
Village, CA), Penny; William H. (Arcadia, CA) |
Assignee: |
American Hospital Supply
Corporation (Evanston, IL)
|
Family
ID: |
23388306 |
Appl.
No.: |
05/353,243 |
Filed: |
April 23, 1973 |
Current U.S.
Class: |
128/207.15;
604/100.01 |
Current CPC
Class: |
A61M
16/044 (20130101); A61M 16/0484 (20140204); A61M
16/04 (20130101); A61M 16/0443 (20140204); A61M
16/0486 (20140204) |
Current International
Class: |
A61M
16/04 (20060101); A61m 016/00 (); A61m
025/02 () |
Field of
Search: |
;128/349B,349X,349BV,351,246,344 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,078,650 |
|
Aug 1967 |
|
GB |
|
867,144 |
|
Feb 1953 |
|
DT |
|
Primary Examiner: Medbery; Aldrich F.
Attorney, Agent or Firm: Barger; Larry N. Merrick; Robert
T.
Claims
We claim:
1. In a medical device for insertion into a body passage,
comprising, in combination:
an administration tube for insertion in a body passage; said tube
including a main balloon circumposed about said tube for inflation
and retaining the tube in a relatively fixed position within a body
passage during medical treatment;
a branch tube connected at an inner end to the interior of said
main balloon for inflating the balloon from outside the body
passage;
pilot balloon means connected in series to the main balloon through
an outer end of the branch tube for access outside the body
passage;
said pilot balloon means comprising an elastic material having
expansion properties appreciably greater than the corresponding
inflation characteristics of the main balloon whereby inflation of
the main balloon causes radical exaggerated inflation of the pilot
balloon for immediately apprizing a user of the inflated condition
of the main balloon in a body passage; and
inflation valve means connected in series to the pilot balloon for
permitting inflation pressure to be administered to the balloons;
the improvement including means for permitting the central portion
of the pilot balloon to freely expand longitudinally and laterally
when inflated, said means comprising a pilot balloon having a free
central portion communicating at one end with an elastic collar of
reduced cross-section, said branch tube having bonded to the outer
end thereof an enlarged, rigid collar, said elastic collar being
stretched in circumposed, air-tight relationship around said bonded
collar for obviating the use of adhesives and bonding of the pilot
balloon collar to said bonded collar and branch tube.
2. The combination as claimed in claim 1 in which said pilot is
stretchingly engaged completely over said bonded collar and a
portion of the branch tube depending therefrom.
3. The combination as claimed in claim 2 in which said inflation
valve means comprises a rear collar portion of said pilot balloon,
a tubular elastic body sealed to the rear collar and including a
pair of integral, valve flaps converging inwardly and downwardly
from the inner wall surface of the tubular body and include free
abutting edge portions normally biased toward each other and
forming a one-way valve, said flaps freely diverging from the inner
surface of the tubular body whereby pressure inside the pilot
balloon biases the flaps to a "closed" condition to trap air
therein, and ready entry of inflation means beyond the flaps is
permitted.
4. The combination as claimed in claim 3 in which said tubular body
includes an integral elastic skirt projecting beyond said elastic
flaps, said skirt being inverted into circumposed relation about
said rear collar of the pilot balloon circumposed on the outer
surface of the tubular body.
5. The combination as claimed in claim 4 in which said skirt
includes a terminal, integral, thickened annular collar circumposed
intermediately about said outer collar of the pilot balloon, below
the connection between the valve flaps and said tubular body.
6. The combination as claimed in claim 5 in which said pilot
balloon comprises a rubber material having a low stretch
resistance, and the main balloon comprises a polyvinyl chloride
plastisol material having a high stretch resistance.
Description
BACKGROUND
Endotracheal tubes are a common way of administering inhalant
anesthetics to a patient such as during surgery. Some physicians
prefer an endotracheal tube over a mask or nasal cannula because
the lower dispensing end of the endotracheal tube is right at the
branch of the bronchial system leading directly to the lungs. To be
effective, the inhalant anesthetic must be absorbed by the
patient's lungs and many physicians want to dispense it very near
to the base of the lungs.
To properly dispense the anesthetic gases into the trachea at the
base of the lungs, the tracheal tube must be sealed against the
inner lining of the trachea. This is to prevent anesthesia gases
from escaping between the endotracheal tube and the tracheal lining
where the gases can be discharged from the patient's mouth. To
prevent this an endotracheal tube usually includes an inflatable
balloon adjacent its lower dispensing end. The tracheal lining is a
tender area of the body and the physician desires to make the seal
with as small a force as possible to insure that the trachea is not
damaged.
Trachea sealing balloons were originally made of a rubber or latex
material so that they were highly stretchable and could be inflated
outwardly against the trachea. These rubber sealing cuffs did have
some disadvantages in that the rubber often included valcanizing
and accelerating agents that could irritate the membrane lining of
the trachea. Also being of highly stretchable rubber material the
tracheal sealing balloon would sometimes longitudinally stretch to
shift either upwardly or downwardly along a dual-lumen insertion
tube of the endotracheal tube. When the balloon was sealed against
the trachea this shifting caused the lower end of the dual-lumen
insertion tube to move relative to the trachea.
To overcome some of the problems with the rubber tracheal balloons
of the past, the plastisol endotracheal balloons were developed.
These were plastisol dipped balloons often of polyvinyl chloride
plastisol that were formed on a mandrel and later secured to a
dual-lumen tube. These plastisol endotracheal balloons were free of
the vulcanizing and accelerating agents of the previous rubber
endotracheal balloons and also reduced the stretch shifting of the
balloon longitudinally along the dual-lumen insertion tube.
With endotracheal tubes having rubber or plastisol balloons there
was a problem of knowing just when and to what extent the tracheal
balloon was inflated. During use the tracheal cuff was inside the
patient's trachea where the physician could not see it. To remedy
this situation the endotracheal tube manufacturers began including
a side branch tube that had a secondary inflatable pilot balloon
outside the patient. The pilot balloon was coupled to the tracheal
balloon through the inflation lumen of the endotracheal tube. Thus
they formed a system of two balloons, one of which was visible and
outside the patient.
It was believed to obtain an accurate reading of the condition of
the invisible tracheal balloon both the balloons had to be made of
the same material. Thus a rubber tracheal balloon was coupled to a
rubber pilot balloon, and likewise a plastisol tracheal balloon was
coupled to a plastisol pilot balloon. The thinking was that a pilot
balloon of the same material as the tracheal balloon could be
squeezed or observed and the condition of the hidden endotracheal
balloon indicated. There was a balance in stretch characteristics
between the two coupled balloons.
SUMMARY OF THE INVENTION
We have found that balanced stretch characteristics between an
endotracheal balloon and a pilot balloon is not required for good
visual and touch indication of the condition of the concealed
endotracheal balloon. On the contrary, the similar materials of the
endotracheal balloon and pilot balloon has a disadvantage.
Particularly with a plastisol endotracheal balloon, the plastisol
pilot balloon has an inflation resistance because it is of limited
stretchability. This inflation resistance causes a greater pressure
to build up in the endotracheal balloon inside the patient. This
creates additional outward force to be placed on the tracheal
lining than is necessary for sealing. The reason for the additional
air pressure inside the plastisol pilot balloon is to expand the
plastisol pilot balloon of limited stretchability to provide a
clear visual indication of the condition of the endotracheal
balloon.
We have overcome this problem by creating an endotracheal tube with
an endotracheal balloon and a pilot balloon that have walls of
substantially different materials and stretch characteristics. The
endotracheal balloon fitting inside the patient has a wall of a
polyvinyl chloride plastisol material that has limited
stretchability. This plastisol endotracheal balloon can expand
outwardly slightly to make a good seal against the inner surface of
the trachea. The wall of the balloon however does not
circumferentially expand more than 50 percent from its normal
uninflated condition before it reaches its elastic limit.
Therefore, the balloon wall is always circumferentially expanded
less than 50 percent from its unstretched condition during normal
use to seal against a patient's trachea. Because the tracheal
balloon is not highly stretchable, the dual-lumen insertion tube
does not longitudinally shift relative to the balloon.
Coupled with the plastisol endotracheal balloon is a highly elastic
latex pilot balloon. The pilot balloon has a wall that
circumferentially stretches substantially more than 50 percent from
its uninflated condition. The latex balloon wall can normally
expand circumferentially 800 percent to 1,000 percent before
reaching its elastic limit. This creates an unbalanced stretch
between the two coupled balloons when both are subjected to a
common internal pressure. Therefore the latex pilot balloon can be
inflated with low pressure air to a large bulbous reservoir that
exerts a low pressure expansion force on the plastisol tracheal
balloon of limited stretchability.
THE DRAWINGS
FIG. 1 is a side elevational view of the endotracheal tube showing
the tracheal balloon and pilot balloon in their natural uninflated
condition;
FIG. 2 is an enlarged sectional view taken along line 2--2 of FIG.
1;
FIG. 3 is an enlarged sectional view taken along line 3--3 of FIG.
1;
FIG. 4 is a view similar to FIG. 2, but showing the pilot balloon
in inflated condition;
FIG. 5 is a sectional view similar to FIG. 3, but showing the
tracheal balloon in an inflated condition;
FIG. 6 is a front elevational view of a forward section of the
endotracheal tube showing its position in the trachea with the
tracheal balloon in a normal uninflated condition;
FIG. 7 is a view similar to FIG. 6, but showing the tracheal
balloon inflated against the trachea lining;
FIG. 8 is a perspective view of the pilot balloon of the
endotracheal tube;
FIG. 9 is a sectional view taken along line 9--9 of FIG. 8; and
FIG. 10 is a sectional view taken along line 10--10 of FIG. 8.
DETAILED DESCRIPTION
Referring to these drawings, FIG. 1 shows the complete endotracheal
tube prior to insertion into a patient's trachea. The endotracheal
tube includes a dual-lumen insertion tube 1 that extends between a
rear end 2 and a forward end 3. Adjacent a forward end of the
endotracheal tube is a main balloon 4 for sealing against a
trachea. This tracheal balloon includes a rear collar 5 and a
forward collar 6 permanently bonded to the dual-lumen tube 1.
Centrally located between collars 5 and 6 is a permanently enlarged
central portion 7.
At the upper end of the dual-lumen tube formed of extruded flexible
polyvinyl chloride is connected a rigid adapter 8 with a tapered
section 9. Fitted on this tapered section 9 is an elbow coupling 10
which is for connecting with an anesthesia machine. Such anesthesia
machine (not shown) feeds the proper mixture of anesthesia gases
through a main lumen of the insertion tube to the patient.
Adjacent an upper end of the dual-lumen tube 1 is a side branch
tube 11 that joins with an inflation lumen 12 (see FIG. 3) of the
dual-lumen tube. Inflation lumen 12 extends forwardly along the
dual-lumen tube to a port 13 beneath enlarged central portion 7.
Port 13 communicates with an interior annular air space 14 between
the enlarged section 7 and the dual-lumen tube 1. Preferably the
inflation lumen 12 is formed within a wall portion of dual-lumen 1
which wall portion defines both the inflation lumen 12 and a main
lumen 15.
At an outer end of side branch tube 11 is connected a highly
stretchable latex rubber pilot balloon 16. This ballon has an
elongated shape with a front collar 17 and a rear collar 18 at a
rearward end. An inflation check valve 19 connects with rear collar
18. Both the check valve 19 and front connector at collar 17 will
be discussed in more detail later in the specification.
As seen in FIG. 1, the main tracheal sealing balloon 4 and pilot
balloon 16 are coupled together through inflation channel or lumen
12. Thus the air pressure in the two balloons are equalized.
However, an important feature of this invention is that although
their pressures are equalized, their stretch characteristics differ
widely and create an unbalanced system relative to elongation of
the walls of the two balloons at a given pressure.
As shown in FIG. 2, the pilot balloon has a thin flattened shape at
its center section in its normally uninflated condition. In FIG. 3,
the polyvinyl chloride plastisol tracheal sealing balloon central
portion 4 in its uninflated condition is spaced outwardly a
distance from the exterior wall of the dual-lumen tube 1. The
purpose of this is so that the enlarged central portion 7 of the
tracheal sealing balloon more closely approaches the diameter of
the patient's trachea in its uninflated condition. Therefore the
degree of inflation of central portion 7 is greatly reduced when
the balloon is expanded to seal against the patient's trachea.
FIGS. 4 and 5 illustrate the substantially different stretch
characteristics of the highly stretchable rubber pilot balloon and
the plastisol trachea sealing balloon 4. When 10 to 15 cc. of air
are injected into the pilot balloon 16 through check valve 19, the
pilot balloon being highly stretchable with less force expands to a
very large shape. Being of latex rubber its percent elongation in a
given wall section of pilot balloon 16 can reach 800 percent to
1,000 percent or more before rupturing. Thus, the pilot balloon
serves as a low pressure, high volume air reservoir for inflating
the tracheal sealing balloon 4. As shown in FIG. 5, the plastisol
endotracheal balloon 4 has a very limited stretchability and in a
given wall section the circumference of an annular section of its
wall expands less than 50 percent. On the other hand, during normal
use, the circumference of an annular section of the pilot balloon
wall may expand to 400 percent and still maintain a low pressure
system between the two balloons. During normal use, the pressure in
the coupled balloons might be 5 to 10 psi above atmospheric and the
capacity of the pilot balloon expand from a capacity of 1 to 3 cc.
at its uninflated condition to a capacity of 25 cc. when
inflated.
Because the plastisol endotracheal balloon 4 has a wall with a
relatively low percent elongation at its elastic limit, i.e., less
than 50 percent elongation, the center section 7 will not
materially stretch longitudinally to shift its position along
dual-lumen tube 1. Thus, when the plastisol balloon 4 is locked
against a patient's trachea, this also locks the dispensing forward
tip 3 at a given location at the base of the lungs. If balloon 4
were highly stretchable, as is the latex pilot balloon 16, the
dual-lumen tube 1 could longitudinally shift in the trachea,
because of a stretch and rolling effect of a latex balloon on the
dual-lumen tube.
With reference to FIGS. 6 and 7, the forward portion of the
endotracheal tube is shown in a patient's trachea 20. In FIG. 6,
the endotracheal tube has just been inserted in trachea 20 and is
in its normal uninflated condition. It is noted that there is an
annular space 21 between the enlarged central portion 7 of the
trachea balloon and an inner lining 23 of the trachea.
When the endotracheal tube is inserted into the trachea as in FIG.
6, the physician properly locates the end 3 at the desired depth in
the trachea, usually immediately above the branched fork of the
left and right bronchus. As shown in FIG. 6, the left bronchus is
on the right side of FIG. 6 and the right bronchus is on the left
side of FIG. 6. This is because the viewer is facing the patient
that is shown in sectional view. In FIGS. 6 and 7, the open forward
end 25 is defined by a lip angularly biased relative to a
longitudinal axis of the dual-lumen tube and end 25 is positioned
to direct gases to the left bronchus. Physicians prefer to have the
very large diagonal opening 25 directed to the left bronchus. The
smaller opening 26 is directed to the right bronchus. This is
because it is more difficult to get anesthetic gases into the left
bronchus. The reason for this is that a patient's anatomy is not
symetrical in this area.
After the endotracheal tube is positioned as in FIG. 7, the
physician regulates the anesthesia machine to administer gaseous
anesthesia mixture, air, or other gas in through the main lumen 15
of the dual-lumen tube. While gas is flowing in the main lumen 15
of the dual-lumen tube it can exit through forward end 25 and side
port 26. The physician then begins slowly inflating the pilot
balloon 16 with air from a hypodermic syringe inserted into check
valve 19. As this occurs, a central portion 7 of the endotracheal
balloon 4 begins expanding until it contacts the lining of the
trachea, as shown in FIG. 7. The physician listens for a hissing
noise indicating the passage of expelled air past the endotracheal
balloon 4. When this hissing noise stops the balloon is inflated
against the trachea. The physician can then insert a small
additional amount of air to insure that anesthesia gases will not
leak past the endotracheal balloon 4.
When the two balloons are so inflated, usually with 5 to 10 psi air
pressure, the pilot balloon 4 will exhibit a substantially enlarged
condition as illustrated generally at FIG. 4. Thus, as the patient
breathes or moves his trachea to slightly contract and expand the
air will be shifted in and out slightly from the highly stretchable
pilot balloon 16. Thus the coupled two balloon system, (a plastisol
balloon with high stretch resistance and a latex rubber balloon
with a very low stretch resistance) provides a low pressure
inflation retention means for gently urging the endotracheal
balloon against the trachea. As shown in FIG. 7, the stretch
resistance of the endotracheal balloon 4 keeps the dual-lumen tube
1 from shifting up and down relative to the branched tubes leading
to the lungs. This gives the physician a very accurate control of
the outlet end and the depth it is located in the trachea.
With reference to this highly stretchable latex rubber pilot
balloon, FIG. 8 shows the balloon in perspective view. The balloon
has a flattened central body section 28 with forward collar section
17 and rearward collar section 19. At FIG. 10, the side branch tube
11 leading from the inflation channel or lumen 12 has an upper end
29. Fitting around the branch tube 11 adjacent end 29 is a rigid
thermoplastic collar. This thermoplastic collar 30 is permanently
bonded to branch tube 11. It can be bonded by cement, solvent
sealing, etc. The forward latex collar 17 is physically stretched
over rigid collar 30 and assumes a neck down retention section 31
adjacent its forward end. Thus the inflation pilot balloon is
permanently locked in an air tight joint to the side branch tube
11.
At an opposite upper end of the rubber pilot balloon 16 is a check
valve system shown in FIG. 9. This check valve system has a tubular
rubber body 35 with a forward end 36. The check valve has an
integral inverted skirt 37. This skirt is formed from a
longitudinal extension of body 35 as shown in dotted line in FIG.
9. This skirt is then expanded outwardly and stretched down over an
outside surface of body 35. This creates an annular gripping
section at 38 that securely locks to an end portion of collar
19.
Within the tubular body 35 are located a pair of converging flap
portions 39 and 40 that are integral with the body 35 and converge
toward the pilot balloon 28. There is a slit or openable section 41
between these two flaps 39 and 40. Thus, when a tapered tip portion
(Luer adapter) of a hypodermic syringe is inserted into syringe
retention pocket 42 and a plunger moved forwardly, air is forced
through slit 41. When the rubber pilot balloon is expanded as shown
in FIG. 4, the back pressure from the latex pilot balloon will
force the check valve slit into a closed position because of the
angular slant of flaps 39 and 40. To deflate the latex pilot
balloon, the tip of a hypodermic syringe (not shown) is inserted
into pocket 42 to a depth sufficient to expand apart reeds 39 and
40. Thus slit 41 opens and air can be withdrawn by the syringe. To
get good valving action between flaps 39 and 40, the rubber valve
is of natural or synthetic rubber of a Shore A hardness of 35.
In the foregoing specification a specific embodiment has been used
to describe the invention. However, it is understood by those
skilled in the art that certain modifications can be made to this
embodiment without departing from the spirit and scope of the
invention.
* * * * *