U.S. patent number 3,854,484 [Application Number 05/310,129] was granted by the patent office on 1974-12-17 for endotracheal tube with liquid fillable cuff.
Invention is credited to Richard R. Jackson.
United States Patent |
3,854,484 |
Jackson |
December 17, 1974 |
ENDOTRACHEAL TUBE WITH LIQUID FILLABLE CUFF
Abstract
Endotracheal and tracheotomy tubes having liquid-fillable
sealing cuffs formed of material permeable to air and substantially
non-permeable to the liquid at sealing pressure. Preferably the
cuff material is a hydrophobic cellular plastic, preferably of
expanded polytetrafluoroethylene. The cuff may be inflated directly
by a pre-packaged, pre-filled syringe or by a collapsible bag
filled with the liquid.
Inventors: |
Jackson; Richard R.
(Marblehead, MA) |
Family
ID: |
26887308 |
Appl.
No.: |
05/310,129 |
Filed: |
November 28, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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191708 |
Oct 22, 1971 |
3766927 |
Oct 23, 1973 |
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Current U.S.
Class: |
128/207.15;
128/207.14; 604/170.03; 604/97.02 |
Current CPC
Class: |
A61M
16/0438 (20140204); A61M 16/044 (20130101); A61M
16/0443 (20140204); A61M 2209/06 (20130101) |
Current International
Class: |
A61M
16/04 (20060101); A61m 025/00 () |
Field of
Search: |
;128/348,349B,349BV,35R,351 ;206/63.2R |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Laudenslager; Lucie H.
Parent Case Text
This application is a continuation-in-part of my copending
application Ser. No. 191,708, filed Oct. 22, 1971, now U.S. Pat.
No. 3,766,927, issued Oct. 23, 1973, entitled "Hydraulic Cuff
Tracheal Tube."
Claims
What is claimed is:
1. A tracheal tube device comprising a tube sized for introduction
of air through the trachea into the lungs of a living being, a cuff
member surrounding and secured to said tube and adapted to be
filled with liquid to cause extension of said cuff into sealing
contact with tracheal tissue about said cuff to create a seal
between said tube and the trachea and a filling lumen extending
proximally from said cuff for communication with a source of
filling liquid, the improvement wherein said cuff comprises a
material which in the presence of said liquid is permeable to air
and substantially nonpermeable to said liquid at the normal
pressure said liquid exerts upon the interior of said cuff while
creating said seal.
2. the tracheal device of claim 1 wherein said cuff material is a
hydrophobic cellular plastic.
3. The tracheal device of claim 2 wherein said cuff material
comprises expanded polytetrafluoroethylene having an open cell
construction.
4. The tracheal tube device of claim 2 wherein said plastic
cuff-forming material is heat-sealed to said tube at the proximal
and distal regions of said cuff.
5. A ready-to-use tracheal assembly comprising a tracheal tube in
accordance with claim 1 in combination with a syringe filled with
water, joined together in a common package.
6. The tracheal device of claim 1 wherein said cuff material has a
predetermined breakthrough pressure to said liquid (i.e., the
pressure above which said liquid can substantially pass through the
material of said cuff) less than the probable tissue-damaging
pressure.
7. The tracheal tube device according to claim 1 in combination
with a filling means which includes a collapsible, non-pressure
applying filling container connected to the proximal end of said
filling lumen, to communicate therethrough with said cuff, said
container, lumen and cuff comprising a closed liquid system, said
lumen and container extending a predetermined distance from said
cuff enabling the container to be vertically spaced a distance
equal substantially to the predetermined gravity head pressure to
be exerted on the tracheal wall by said cuff when there is no air
pressure differential across the trachea, said system, when said
container is raised above said cuff capable of permitting free flow
of liquid from said container into said cuff under influence
substantially only of the gravity head, with attendant non-pressure
applying partial collapse of said container.
8. The assembly of claim 7 wherein said collapsible container
comprises a collapsible bag formed of flaccid material.
9. The assembly of claim 8 wherein said bag is defined by flexible
plastic sheet.
10. The assembly of claim 7 wherein said container extends less
than 25 cm from said cuff and said closed liquid system is adapted
to contain water.
11. The device of claim 1 wherein said liquid includes
surface-effective anesthetic, the normal operating pressure within
said cuff being below the effective break-through pressure at which
said anesthetic can pass through said material (i.e., the pressure
above which said liquid including said anesthetic can substantially
pass through the material of said cuff), and the material of the
cuff selected so that elevating the pressure within said cuff above
said break-through pressure is effective to apply said anesthetic
to said tracheal tissue.
Description
This invention relates to endotracheal (including trachetomy) tubes
of the low-pressure type in which liquid within the cuff produces a
minimal cuff pressure against the tracheal tissue to provide a seal
for control of breathing with anesthesia or respirator machines.
The main object of the invention is to provide an endotracheal tube
of this type which is improved with regard to ease of
administration.
The invention features an endotracheal tube in which the cuff
material is permeable to air but is non-permeable to the filling
liquid at the desired sealing pressure. Preferably the cuff
material is hydrophobic, preferably cellular plastic, preferably
expanded polytetrafluoroethylene heat-sealed to the tube and
preferably the endotracheal tube is packaged with a liquid-filled
syringe in a ready-to-use assembly. Another embodiment features a
pre-filled collapsible container as of flaccid material connected
to fill the cuff as the container collapses and as air is expelled
through the cuff wall. These and other objects and features will be
understood from the description of the preferred embodiment taken
in conjunction with the drawings wherein:
FIG. 1 is a diagrammatic cross-sectional view showing the inflation
of the cuff of the endotracheal tube by means of a syringe;
FIG. 2 is a cross-sectional view taken at line 2--2 of FIG. 1;
FIG. 3 depicts a ready-to-use endotracheal tube assembly; and
FIG. 4 is a view similar to FIG. 1 of an endotracheal tube device
combined with a collapsible filling container according to the
invention.
Referring to FIG. 1, the endotracheal tube 10 has a connector 12
and the usual curved configuration terminating in a slanted distal
end 14. Cuff 16 inflated by liquid through lumen 18 is disposed
circumferentially about the tube proper to seal against the
tracheal tissue 20. The cuff, in the form of a tube of diameter
considerably greater than tube 10, is heat-sealed at its ends to
tube 10. The lumen 18 extends to a proximal filling connector 22
provided for receiving a syringe 24 filled with the hydraulic
fluid. The material defining the cuff 16 in this preferred
embodiment is comprised of heat-sealable expanded
polytetrafluoroethylene (DuPont's teflon) which is of thin, pliable
sheet, expanded form, available under the trade designation
Gore-tex from W. L. Gore and Associates Inc. of Newark, Del. This
material has microscopic open cells, is highly permeable to air,
and is nonpermeable to water or other hydraulic fluid up to a
prespecified breakthrough pressure. In this preferred embodiment
the breakthrough pressure is selected to be in excess of 20 cm
H.sub.2 O head, dimension H in FIG. 1. The technique for
administering the endotracheal tube comprises first inserting the
endotracheal tube through the mouth into the patient's trachea
according to the usual procedure and then connecting the syringe 24
filled with the hydraulic fluid to filling connector 22. Thereupon
the plunger of the syringe is depressed in the direction of the
arrow forcing liquid through the syringe and through the lumen 18
into the cuff 16.
Referring to FIG. 2, the liquid, e.g., water, 26 proceeding in the
filling direction through lumen 18 applies pressure to the air in
volume 17 of the cuff 16 and because of the air-permeability of the
cuff material 16, this air is expelled to the trachea, see arrows
A. As the liquid fills the cuff, as indicated in the dotted lines,
this expulsion of air continues. When resistence is felt on the
plunger, the cuff is filled with liquid, no air remaining. Upon
detachment of the syringe 24 from the filling connector 22, the
liquid is allowed to restore to ambient pressure with the release
of a few drops of liquid from the filling point, thus establishing
the pressure of the liquid within the cuff as the height H between
the filling point 22 and the cuff 16. Thereupon the lumen is sealed
with pinch clamp 23.
Thus it is seen that a liquid-filled cuff is provided which through
the weight of the water establishes a desired low pressure in the
manner previously taught by me (prior art) with the attendant
advantages of ensuring adequate blood circulation in the contacted
tissue and avoiding tissue damage. According to the present
invention, because of the self-purging of air, the cuff is readily
fillable with no special procedures required as might detract from
the acceptability of the liquid-filled system. Air pockets are
avoided in the hydraulic cuff and at the same time special
procedures such as evacuating the lumen prior to filling are
avoided.
In an alternative embodiment the breakthrough pressure of the cuff
material may be predetermined at such a level as to provide a
safety relief--that is, should the cuff be inflated with the
syringe above its predetermined breakthrough pressure, it will
automatically relieve itself down to the breakthrough pressure.
Thus by predetermining the breakthrough pressure below the probable
damage pressure for tracheal tissue, i.e., below 30 cm H.sub.2 O, a
safety feature can be provided against excessive inflation pressure
even if the preferred gravity head technique just outlined is not
followed. The particular breakthrough pressure must be specified in
relation to the ambient chemical constituents. Thus the presence of
conventional pre-applied lubricant to the cuff with a water filling
will cause water-breakthrough the cuff at a lower pressure than
will a system without the lubricant.
In another embodiment the liquid may be supplied to the cuff
through the filling device as shownn in my copending patent
application Ser. No. 191,708, incorporated by reference herein.
Referring to FIG. 4, the filling lumen is flexible and has its
proximal end connected to a collapsible, non-pressure applying
filling container 24a. The container, lumen, and cuff comprise a
closed liquid system, the lumen and container extending a
predetermined distance from the cuff enabling the container to be
vertically spaced a distance equal substantially to the
predetermined gravity head pressure to be exerted on the tracheal
wall by the cuff when there is no air pressure differential across
the trachea. (It will be understood that when the respirator
applies pressure to the patient, that pressure will be transmitted
to liquid in the cuff and transmitted thereby against the tracheal
tissue, this occurring periodically with the periodic operation of
the respirator.)
For filling, when the container is raised above the cuff, the
system is capable of permitting free flow of liquid from the
container into the cuff under influence substantially only of the
gravity head with attendant non-pressure applying partial collapse
of the container. The air-permeable cuff material may exhaust any
resident air as the liquid flows downwardly to insure that the cuff
is fully filled with liquid.
In another embodiment, according to the invention, the hydraulic
fluid which fills the cuff incorporates liquid surface effective
anesthetic. Normally the fluid pressure in the cuff is below
break-through pressure. Periodically, however, perhaps every 2 or 4
hours, the system is designed to permit the attendant to
temporarily over-pressure the cuff above break-through pressure,
thus causing some of the liquid and anesthetic to pass through the
cuff wall, anesthetizing the tissue and enabling the patient to
more easily tolerate the presence of the tube. In the case of the
embodiment of FIG. 1 this is accomplished by temporarily releasing
pinch clamp 23 and applying the syringe. In the case of the
embodiment of FIG. 4 this is accomplished by similarly releasing
clamp 23 and squeezing the still partially filled bag or
container.
For use in the foregoing embodiments a specific example of cuff
material is Gore-tex of 0.4 density (expanded, comprising in volume
40 percent polytetrafluorethylene and 60 percent air) in sheet form
of 0.004 inch thickness backed with a thin perforated polyethylene
film, and having by itself a break-through pressure of 10-12 p.s.i.
The effective break-through pressure is lowered by the presence of
usual amounts of endotracheal tube lubricant containing
polyethylene and propylene glycols to a level of about 1.0
p.s.i.
Other air-permeable materials may be used including films made
air-permeable by nuclear bombardment, and other variations will be
understood to be within the spirit and scope of the following
claims.
* * * * *