U.S. patent number 3,640,282 [Application Number 05/061,586] was granted by the patent office on 1972-02-08 for tracheal tube with normally expanded balloon cuff.
This patent grant is currently assigned to SAID Kamen, by said Wilkinson. Invention is credited to Jack M. Kamen, Carolyn J. Wilkinson.
United States Patent |
3,640,282 |
Kamen , et al. |
February 8, 1972 |
TRACHEAL TUBE WITH NORMALLY EXPANDED BALLOON CUFF
Abstract
A tracheal tube for use in intubation of a trachea, and
embodying a resilient, yieldable cuff for effecting an air seal
between the tube and the trachea. The cuff contains a resilient
member, such as a rubber sponge, which resiliently maintains the
cuff in an expanded position away from the tube. The cuff may be
contracted by means of a vacuum applied thereinto by a secondary
tube mounted on the tracheal tube. The cuff in its normal expanded
position within the trachea affords a good seal and at the same
time prevents injury to the tracheal wall by virtue of its
yieldable contact therewith.
Inventors: |
Kamen; Jack M. (Gary, IN),
Wilkinson; Carolyn J. (Chicago, IL) |
Assignee: |
SAID Kamen, by said Wilkinson
(N/A)
|
Family
ID: |
22036748 |
Appl.
No.: |
05/061,586 |
Filed: |
August 6, 1970 |
Current U.S.
Class: |
128/207.15;
604/103.11 |
Current CPC
Class: |
A61M
16/04 (20130101); A61M 16/0434 (20130101) |
Current International
Class: |
A61M
16/04 (20060101); A61m 025/00 () |
Field of
Search: |
;128/348,351,349B,349BV,344,246,208 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
We claim:
1. A tracheal tube comprising
a. an elongated tube having an outer surface, proximal end and
distal end,
b. a cuff mounted on said elongated tube adjacent to said distal
end and in spaced relation to said proximal end,
c. said cuff comprising
1. a flexible tubular cover
a. disposed on said elongated tube in surrounding relation thereto,
and
b. having its ends secured to said outer surface, and
2.
2. a resilient body portion mounted in said cover,
d. said body portion having
1. normally an expanded position, wherein it is effective to hold a
portion of said cover outwardly away from said elongated tube,
and
2. a collapsed position, wherein the outer surface thereof is
disposed closer to said elongated tube than in said expanded
position to thereby permit said portion of said cover to assume a
position closer to said elongated tube, and
e. means connected to said cuff for creating and releasing a vacuum
in said cover to thereby cause said body portion to move toward
said collapsed and
expanded positions, respectively. 2. A tracheal tube comprising
a. an elongated tube having a longitudinally extending opening for
feeding working fluid therethrough, a proximal end and a distal
end,
b. a cuff mounted on said elongated tube adjacent said distal end
and in spaced relation to said proximal end for effecting a seal
between said elongated tube and a trachea in which it is
disposed,
c. said cuff including resilient means for normally holding said
cuff in expanded position wherein it extends outwardly from said
elongated tube under atmospheric conditions, and
d. means operatively connected to said cuff for
1. creating a vacuum therein and thereby move said cuff inwardly
from said expanded position for movement of said cuff through such
a trachea, and
2. releasing such a vacuum in said cuff to thereby permit said cuff
to move outwardly toward said expanded position under urging of
said resilient means into position to effect said seal with such a
trachea in which said tube is disposed in operative position.
3. A tracheal tube as defined in claim 2, and in which
a. said cuff includes a cover member, and
b. said resilient means comprises a resilient body portion disposed
in said cover member for yieldingly urging said cover member
outwardly away from said elongated tube.
4. A tracheal tube for use in intubating the trachea and
comprising
a. an elongated tube for insertion into operative position into a
trachea for feeding air into and out of the latter and having a
proximal end and a distal end,
b. a cuff mounted on the distal end portion of said elongated tube
in spaced relation to said proximal end thereof in position to be
disposed within such a trachea when said elongated tube is disposed
in said operative position therein,
c. said cuff having
1. a normal position wherein it is disposed in radially outwardly
expanded position relative to said elongated tube, and
2. another position wherein it extends a lesser distance, radially,
from said elongated tube than in said normal position,
d. said cuff including resilient means for normally yieldingly
holding said cuff in said normal position,
e. said cuff being movable
1. into said other position for movement through such a trachea,
and
2. toward said normal position from said other position into a
position for effecting a seal between said elongated tube and said
trachea within which said cuff is so disposed, and
f. means operatively connected to said cuff for creating and
releasing a vacuum therein and thereby causing said cuff to move
toward said other and normal positions, respectively.
5. A tracheal tube as defined in claim 4 and in which
a. said cuff comprises
1. a flexible cover secured to said elongated tube, and
2. a resilient filler mounted in said cover for holding the latter
in said normal position when said vacuum is completely released and
said cuff is completely free to expand.
6. A tracheal tube as defined in claim 5 and in which
a. said filler has interstices spread therethrough.
7. A tracheal tube as defined in claim 4 and in which
a. said cuff comprises
1. a flexible tube
a. disposed in surrounding relation to said elongated tube, and
b. having end portions hermetically sealed to said elongated tube,
and
2. a spongelike elastic mass mounted in said flexible tube for
yieldingly urging the latter outwardly.
8. A tracheal tube as defined in claim 7 and in which
a. said flexible tube is elastic, and
b. said elastic mass comprises foam rubber.
9. A tracheal tube as defined in claim 4 and in which
a. said last mentioned means comprises another tube,
b. said cuff comprises
1. a flexible cover
a. disposed in surrounding relation to said elongated tube and to
said other tube, and
b. hermetically sealed to said last mentioned tubes, and
2. a spongelike elastic body portion disposed around said elongated
tube within said cover for yieldingly urging the latter outwardly
away from said elongated tube.
10. A tracheal tube as defined in claim 4 and in which
a. said elongated tube is flexible,
b. said last mentioned means comprises another tube secured to said
elongated tube and extending into said cuff
c. said cuff comprises
1. an elastic latex rubber tube mounted on said elongated tube and
said other tube in surrounding relation thereto with the ends of
said elastic tube secured to said elongated tube in hermetically
sealed relation thereto and one of said ends of said elastic tube
hermetically sealed to said other tube, and
2. a resilient foam rubber body portion mounted around said
elongated and other tubes within said elastic tube in position to
yieldingly urge said elastic tube outwardly away from said
elongated and other tubes between said ends of said elastic tube.
Description
BACKGROUND OF THE INVENTION
The present invention relates to tracheal tubes and, more
particularly, to tracheal tubes of the type embodying a cuff for
effecting a seal between the tube and a trachea.
The primary object of the present invention is to afford a novel
tracheal tube.
Another object is to enable an effective seal between a tracheal
tube and a trachea to be effected in a novel and expeditious
manner.
A further object of the present invention is to afford a novel cuff
on a tracheal tube.
Tracheal tubes, as that term is used herein, may be of different
types, such as, for example, orotracheal tubes, nasotracheal tubes
and tracheostomy tubes. Also, such tubes may be flexible, the main
body portion thereof being made of flexible material such as, for
example, rubber or a suitable plastic material, such as, for
example, polyethylene, or the like, or they may be stiff or rigid,
being made of material such as stainless steel, or the like, the
latter type of tubes being primarily useful as tracheostomy tubes.
The present invention is intended for use in the construction of
all such tracheal tubes.
As is well known in the art, tracheal tubes are commonly inserted
into a person's trachea for various purposes, such as, for example,
to enable the person to breathe, or to enable intermittent positive
pressure ventilation of the respiratory tract to be carried out.
Often, it is highly important, particularly in such instances as
when positive pressure ventilation of the respiratory tract is to
be carried out, that an airtight or substantially airtight seal be
provided between the tracheal tube and the trachea. Heretofore,
various attempts have been made to effect such seals between
tracheal tubes and the trachea, such as, for example, by using
large tubes which completely fill the trachea, or using cuffs which
are inflatable by forcing air or other working fluid thereinto.
However, each of the methods of sealing heretofore known in the art
have presented certain difficulties and complexities. It is an
important object of the present invention to overcome such
difficulties and complexities.
In the cuffed tubes heretofore known in the art, cuffs in the form
of elastic diaphragms or tubes made of elastic material, such as
latex rubber, have been mounted on the main tube in sealed
surrounding relation thereto, with the cuff normally, and when
being inserted into the trachea, being in uninflated or deflated
condition. With such devices, after the intubation device has been
inserted into the trachea, the cuff is inflated, like a balloon, by
feeding air or other working fluid thereinto at a positive pressure
to thereby expand the cuff into engagement with the inner wall of
the trachea. However, it has been found that such devices have
several inherent disadvantages, the primary disadvantage being that
they commonly cause injury to the trachea, causing lesions such as
tracheal stenosis, tracheal malacia and localized erosion, and the
like, particularly if it is necessary for the tube to remain in the
trachea for prolonged periods of time. Various attempts have been
made to prevent such injuries from occurring with the cuffs
heretofore known in the art, such as, for example, by using
alternately inflated double-cuffed tubes; using intermittently
inflated cuffs; and by serial adjustment of the level of the cuffed
tubes. However, these attempts have met with only limited success.
It is another important object of the present invention to
eliminate such injuries to the trachea, or at least to
substantially reduce the likelihood and incidence of their
occurring.
Another object of the present invention is to enable a seal to be
effected in a novel and expeditious manner between a tracheal tube
and a trachea by volume occlusion as distinguished from the
pressure occlusion heretofore afforded by the aforementioned
inflatable cuffs heretofore known in the art.
A tracheal tube constructed in accordance with the present
invention comprises an elongated tube, which may be either flexible
or stiff, for insertion into the trachea for feeding air, or the
like, into and out of the respiratory tract of a patient. A cuff is
mounted on the elongated tube for effecting a seal between the tube
and the trachea, after the tube has been inserted into operative
position in the trachea. The cuff comprises a flexible, air
impervious cover disposed in surrounding relation to a portion of
the tube and hermetically sealed thereto, and a preferably porous
resilient body portion, made of suitable material, such as, for
example, sponge rubber, mounted around the elongated tube, within
the cover for yieldingly urging the cover outwardly away from the
tube. The tracheal tube also includes an auxiliary tube extending
into the cover, in hermetically sealed relation thereto. With this
construction air may be withdrawn from the cover through the
auxiliary tube, to thereby cause the cuff to collapse to facilitate
the insertion thereof into a trachea, and, after the cuff is in the
desired position in the trachea, the auxiliary tube may be opened
to the atmosphere and thereby permit the cuff to expand into
yielding, sealing engagement with the trachea.
Other and further objects of the present invention will be apparent
from the following description and claims and are illustrated in
the accompanying drawings which, by way of illustration, show a
preferred embodiment of the present invention and the principles
thereof and what we now consider to be the best mode in which we
have contemplated applying these principles. Other embodiments of
the invention embodying the same or equivalent principles may be
used and structural changes may be made as desired by those skilled
in the art without departing from the present invention and the
purview of the appended claims.
DESCRIPTION OF THE DRAWINGS
In the drawings:
FIG. 1 is a fragmentary side elevational view of a tracheal tube
embodying the principles of the present invention;
FIG. 2 is a longitudinal sectional view taken substantially along
the line 2--2 in FIG. 1, and showing the tracheal tube disposed in
operative position in a trachea, which is shown
diagrammatically;
FIG. 3 is a transverse sectional view taken substantially along the
line 3--3 in FIG. 2;
FIG. 4 is a transverse sectional view taken substantially along the
line 4--4 in FIG. 5; and
FIG. 5 is a view similar to FIG. 2, but showing certain parts
disposed in different operative positions.
DESCRIPTION OF THE EMBODIMENT SHOWN HEREIN
A tracheal tube or intubation device 1, embodying the principles of
the present invention, is shown in the drawings to illustrate the
presently preferred embodiment of the present invention.
The tracheal tube 1 embodies, in general, an elongated tube 2
having a cuff 3 mounted on one portion thereof, with a tube 4
extending into the cuff 3 for a purpose which will be described in
greater detail presently. The tube 2 may be of any suitable
construction and is for the purpose of feeding air, or the like,
into and out of the respiratory tract of a patient into whose
trachea the tracheal tube or intubation device 1 has been inserted.
Commonly, when the tracheal tube 1 is to be used as an endotracheal
tube, such as, either an orotracheal or nasotracheal tube, the tube
2 thereof is preferably flexible and may be made of any suitable
material such as, for example, rubber or a suitable plastic, such
as polyethylene, or the like. However, in other instances, such as,
for example, when the tracheal tube 1 is to be used as a
tracheostomy tube, it may be desired to have the tube 2 thereof be
rigid in construction and made of suitable material such as, for
example, stainless steel, or the like.
In the drawings, the tube 2 is shown as having a distal end 5,
which is cut on a slope or bevel 6, FIG. 1, extending across the
end opening of the tube 2 so as to facilitate insertion of the tube
2 into the trachea. The end portion 5 also has a transverse opening
7, FIG. 2, formed therein, such construction for tracheal tubes
being common as is well known in the art. The other, or proximal
end 8 of the tube 2 may be of any suitable configuration, such as
that shown in FIG. 1. It will be understood by those skilled in the
art that the tube 2 may be of any suitable length, such tubes,
commonly being in the nature of nine to fourteen inches in length,
when used in an endotracheal tube, and commonly being considerably
shorter when used as a tracheostomy tube.
The cuff 3, FIGS. 3 and 5, includes an air impervious cover 9 and a
body portion 10 disposed within the cover 9. Both the body portion
10 and the cover 9 are disposed around a portion of the tube 2 in
spaced relation to the ends 5 and 8 thereof. In practice, the cuff
3 will normally be disposed substantially closer to the end 5 of
the tube 2 than to the end 8 thereof, such as, for example, being
spaced from the end portion 6 a distance in the nature of one-half
to three-fourths of an inch on a tube having an overall length of
14 inches. However, as will be appreciated by those skilled in the
art, the cuff 3 may be disposed at any suitable location along the
tube 2, the particular location thereof depending upon the intended
use of the intubation device 1. For example, normally, when the end
5 of the tube is to be inserted into the windpipe or trachea, only,
the cuff 3 preferably will normally be spaced a relatively short
distance from the end portion 6, such as, for example, the
aforementioned one-half to three-fourths of an inch. However, if
the intubation device 1 is to be inserted further than the trachea,
such as, for example, into the bronchia, the cuff 3 preferably
would be spaced a greater distance from the end portion 6 so that
it would remain in the trachea when the end portion 5 was inserted
into the bronchia.
The cover 9 is flexible and may be made of any suitable material
such as, for example, latex rubber or a suitable plastic sheet
material, such as, polyethylene, or the like. Preferably, it also
is elastic for reasons which will be discussed in greater detail
presently, and, of course, under such circumstances it would be
made of a suitable elastic material such as the aforementioned
latex rubber.
The cover 9 is tubular in form, and the end portions 11 and 12
thereof are hermetically sealed to the outer surface of the tube 2
by suitable means, such as, for example, being vulcanized thereto
or by a suitable cement such as rubber cement, or the like. In the
preferred form of the intubation device 1 shown in the drawings,
reinforcing rings 13 are mounted on the end portions 11 and 12 of
the cover 9 to insure the maintenance of any effective seal between
the end portions 11 and 12 and the tube 2. The reinforcing rings 13
may be made of any suitable material such as rubber or a suitable
plastic such as polyethylene and may be secured to the outer faces
of the end portions 11 and 12 by suitable means such as
vulcanization or a suitable cement.
The body portion 10 affords a resilient mass which preferably
completely fills the cover 9 between the end portions 11 and 12
thereof and, when the intubation device 1 is disposed in normal
inoperative position, outside the trachea, preferably is effective
to yieldingly hold the cover 9 in fully expanded position, as shown
in FIG. 1. The body portion 10 may be made of any suitable
resilient material, but, preferably, is made of a spongelike
resilient material having a multitude of interstices spread
therethrough, such as, for example, sponge rubber or a suitable
resilient plastic material, such as, for example, foamed
polyurethane, or the like, for a purpose which will be discussed in
greater detail presently.
The tube 4 has one end portion 14 extending into the cuff 3. As
shown in the drawings, the tube 4 extends along the tube 2, and,
preferably, the tube 4 is formed integrally with the tube 2 and
terminates in a free end portion 15 which extends outwardly beyond
the end 8 of the tube 2. However, as will be appreciated by those
skilled in the art, the tube 4 may be formed separately from the
tube 2 and inserted into the cuff 3 in a suitable manner without
departing from the purview of the broader aspects of the present
invention.
In the intubation device shown in the drawings, wherein the tube 4
extends along tube 2, FIG. 2, the tube 4 extends through the end
portion 11 of the cover 9 and the latter is hermetically sealed
thereto in the same manner as it is so sealed to the tube 2. With
this construction, it will be seen that when the tube 4 is open to
the atmosphere at the end portion 15 thereof, and the intubation
device 1 is disposed outside of a trachea, the body portion 10 is
effective to yieldingly hold the cover 9 in fully outwardly
extended position, as shown in FIG. 1. However, by the application
of a vacuum to the end portion 15 of the tube 4, air may be
withdrawn from within the cover 9 through the tube 4 to thereby
afford a partial vacuum within the cuff 3 and cause it to collapse
from the position shown in FIG. 1 to a position such as that shown
in FIG. 5, because of the imbalance between the pressures within
the cover 9 and the atmospheric pressure exteriorly thereof. It
will be seen that by making the body portion 10 of a resilient
material having interstices therein, such as, for example, the
aforementioned foam rubber or foamed polyurethane, the withdrawal
of air from within the cover 9 may be substantially uniform
throughout the entire area between the end portions 11 and 12
thereof, so as to effect a relatively uniform, substantially
complete collapse of all portions of the cover 9 throughout the
length thereof.
With the intubation device 1 constructed in the aforementioned
manner, when it is desired to insert it into a trachea, such as the
trachea 16 diagrammatically shown in FIGS. 2-5, a partial vacuum
may be applied to the end portion 14 of the tube 4 to thereby cause
the cuff 3 to move from its normal expanded position shown in FIG.
1 to a collapsed position such as that shown in FIG. 5. While
maintaining the vacuum on the tube 4, the tracheal tube 1 may be
inserted into a trachea, such as the trachea 16, the cuff 3 being
disposed in the aforementioned collapsed position to thereby
facilitate such insertion. Thereafter, when the tracheal tube 1 has
been inserted into the desired position in the trachea 16, the
vacuum on the tube 4 may be released to thereby permit the cover 9
to be expanded outwardly by the yielding expansion of the resilient
body member 10, the expansion of the cover from the collapsed
position being to a position wherein it is yieldingly held by the
body portion 10 in engagement with the inner wall 17 of the trachea
16, FIGS. 2 and 3. Such expansion, it will be seen, is caused by
the resiliency of the body portion 10 and is a direct result of the
volumetric expansion thereof. This is to be distinguished from the
expansion of the aforementioned cuffs heretofore known in the art,
which cuffs are expanded by the application of a positive pressure,
by the introduction of air or other working fluid thereinto under
pressure.
It will be remembered that the cuff 3 may be made of any suitable
flexible material, but that preferably it is made of an elastic
material, such as, for example, latex rubber. The latter is true
because with the cover made of a suitable elastic material it may
be so constructed that no wrinkles are formed therein in any
position thereof between the fully expanded position shown in FIG.
1 and the collapsed position shown in FIG. 5, whereas with some
materials which are flexible but do not have this degree of
elasticity such as, for example, certain plastic sheet materials,
and the like, wrinkles could be formed when the cover 9 is disposed
in a position wherein it was extended outwardly less than that
which it occupies when in fully extended position. Although it is
of little or no importance whether the cover 9 is wrinkled when the
cuff 3 is in fully collapsed position, as shown in FIG. 5, and it
is not essential or an absolute requirement that no wrinkles be
formed in the cover 9 when the cuff 3 is disposed in operative
engagement with a trachea, such as is shown in FIG. 2, it is
preferred that no such wrinkles be present when the cuff 3 is in
operative engagement with a trachea. Therefore, to insure against
such wrinkles, we prefer that the cover 9 be made of a suitable
elastic material such as, for example, the aforementioned latex
rubber.
As will be appreciated by those skilled in the art, the size of the
cuff 3 in its normal, fully expanded state, as shown in FIG. 1, and
the characteristics of the cover 9 and the body portion 10 are
factors in the determination of the pressure with which the cuff 3
presses outwardly on the trachea such as the trachea 16, when it is
disposed in operative engagement with the inner wall 17 of such a
trachea. Preferably, the size of the cuff 3 and the characteristics
of the cover 9 and the body portion 10 are such that the outward
pressure of the cuff 3 on a trachea is no greater than fourteen
centimeters of water, when the intubation device 1 is in normal
operative position in the trachea and the cuff 3 is in effective
sealing engagement with the latter. However, as will be appreciated
by those skilled in the art, this is set forth merely by way of
illustration of the preferred embodiment of the present invention
and not by way of limitation and variations in the size and
characteristics of the cuff 3 may be made by those skilled in the
art without departing from the purview of the present
invention.
From the foregoing it will be seen that the present invention
affords a novel intubation device embodying a cuff which is
constructed and operates in a novel and expeditious manner.
Also, it will be seen that the present invention affords a novel
intubation device for use in tracheas wherein effective sealing
between the intubation device and the trachea may be afforded in a
novel and expeditious manner.
In addition, it will be seen that the present invention affords a
novel intubation device which is practical and efficient in
operation and which may be readily and economically produced
commercially.
Thus, while we have illustrated and described the preferred
embodiment of our invention, it is to be understood that this is
capable of variation and modification, and we therefore do not wish
to be limited to the precise details set forth, but desire to avail
ourselves of such changes and alterations as fall within the
purview of the following claims.
* * * * *