U.S. patent number 3,769,983 [Application Number 05/067,123] was granted by the patent office on 1973-11-06 for medical devices.
Invention is credited to Abraham Dov Merav.
United States Patent |
3,769,983 |
Merav |
November 6, 1973 |
MEDICAL DEVICES
Abstract
Apparatus for intubation within body passages, comprising an
elongated tube having the usual opening at the distal end and means
for connection to a source of fluid, such as air, at the other end.
Occlusion means is located about the surface of the tube near the
open end to seal the space between the passage and the tube against
flow of air. The occlusion means comprises a bag or canopy secured
at its center, to the outer surface of the tube and terminating in
a free edge directed toward the distal end being substantially open
for receipt of air from the direction of the open end of said tube.
The canopy is adapted to be distended against the inner surface of
the passage to form the required seal.
Inventors: |
Merav; Abraham Dov (Riverdale,
NY) |
Family
ID: |
22073859 |
Appl.
No.: |
05/067,123 |
Filed: |
August 26, 1970 |
Current U.S.
Class: |
128/207.15;
604/104 |
Current CPC
Class: |
A61M
16/0447 (20140204); A61M 16/04 (20130101); A61M
16/0445 (20140204); A61M 16/0452 (20140204) |
Current International
Class: |
A61M
16/04 (20060101); A61m 025/00 () |
Field of
Search: |
;128/348,351,245,208 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed:
1. A device for intubation in a tracheal passage or the like,
comprising a hollow tube having a distal end for insertion into
said tracheal passage and a proximal end adapted to be connected to
means for selectively delivering a gas through said tube, a canopy
of flexible material surrounding said tube, spaced proximally of
said distal end for preventing back flow of gas in said passage
about said tube, said canopy comprising a dome portion having an
edge oriented to the proximal end of said tube, an expandable body
portion and a relatively non-expandable distal edge oriented to the
distal end of said tube, said proximal edge of said dome portion
being secured to the outer surface of said tube to prevent
substantial movement of gas therebetween, said distal edge having a
circumference less than the greatest circumference of the body
portion when said body portion is distended and being spaced
radially from the surface of said tube to permit gas to freely flow
into said canopy, said body portion being expandable by said gas to
distend within the passage to occlude the same.
2. The device according to claim 1, including means connecting the
distal edge of said canopy to the surface of said tube to limit
proximal movement and lateral shifting of said edge relative
thereto.
3. The device according to claim 2 wherein the connecting means
comprise one or more shroud lines about the distal edte, said
shroud lines extending to the surface of said tube.
4. The device according to claim 2 wherein the dome portion of said
canopy is substantially circular and said body portion is
symmetrical about said tube, the distal edge of said canopy lying
in a plane substantially perpendicular to the tube.
5. The device according to claim 1 including supporting members
integrally formed with said dome portion and symmetrical with the
axis of said tube for maintaining said dome in distended
position.
6. The device according to claim 1 wherein said canopy is formed
with a plurality of pleats expandable under air pressure.
7. The device according to claim 1 wherein the distal edge of said
canopy is provided with a circumferential reinforcing member.
8. The device according to claim 1 wherein said canopy is formed
with circumferential areas of at least two different degrees of
expandability.
9. The device according to claim 1 wherein said canopy is secured
to said tube by means permitting its selected removal.
Description
BACKGROUND OF INVENTION
The present invention relates to apparatus for use in prolonged
artificial respiration and in particular to improved intratracheal
tube.
As an alternate to the supply of oxygen through tank, tent or chest
respirator systems, recent treatment procedures for such serious
illness as acute poliomyelitis call for ventilation by supplying
auxiliary air under forced or positive pressure directly to the
lungs through an endotracheal or tracheostomy tube (herein after
sometimes referred to collectively as intratracheal tubes) inserted
and left indwelling within the trachea. A pulsating supply of
pressurized air automatically forces the rhythmic expansion of the
lungs and maintains the chest and lungs properly inflated
especially when the patient is unable to provide even the minimum
muscular activity to sustain any breathing. Intubation has a
further advantage in that it leaves the patient free of an
enclosing housing or chest harness making the patient more
accessible to observation and auxiliary treatment.
Since the body tends to reject and expel air which is artificially
supplied and since the diameter of simple intratracheal tubes would
normally allow the escape of air, the air is either supplied under
extremely high pressures or as is preferable under low pressures by
providing the tube with means for sealing the annular space between
the tube and the traches walls. Commonly, such means take the form
of an elastic annular "cuff" of either a balloon of toroidal or
spherical shape or an assembly of one or more flat discs, which are
adapted to be independently inflated to seal against the mucosal
lining and occlude the trachea.
An extensive survey of presently used "cuffed" intratracheal tubes
was made by Drs. Carrol and Hedden in the September 1969 issue of
the Journal of Anesthesiology (Vol. 31, No. 3, Anesthesiology,
pages 275-281) to which reference can easily be made. Briefly such
"cuffed" tubes fall within two categories namely, (a) those in
which the "cuff" is an integral part of the tube, and (b) those in
which the "cuff" is separable. In either case, the cuff requires a
high degree of inflationary pressure and volume to extend into
sealing condition and a high degree of what is referred to as
"tracheal wall pressure" to maintain it sealed against the wall of
the trachea. With these conventional "cuffs" the "tracheal wall
pressure" is generally significantly greater than the pressure
sustaining capillary blood flood so that blockage of blood
(ischemia) through the mucous lining occurs. Particularly high
pressure is required to distend the cuff against the force of its
own residual elasticity (residual pressure), maintain the cuff in
inflated condition against the pressure of the treachea or movement
of the patient etc (intra-cuff pressure) and maintain the occlusion
of the pressure against leakage of respiratory air (sealing
pressure). As a result of both the intubation of an unnatural
device and the maintenance of prolonged pressure against the mucous
lining of the trachea serious side illnesses and complicating
diseases, often worse than the respiratory illness itself occur.
Not even the standard procedure of deflating the "cuff" for a few
minutes or so every hour successfully overcome this problem.
The above problems are accentuated when one appreciates the fact
that since the intubation is hidden from view of the doctor or
surgon, accurate measurement of pressure cannot be obtained. It is
thus more than likely that, in order to insure minimal efficiency
the operator will set the pressure at a level even greater than
that necessary for the secure occlusion of the trachea.
Recent medical literature is replete with studies and surveys of
tracheal stenosis, tracheomalacia, ulceration, erosion of the
tracheal wall, and the formation of lesions resulting from the
prolonged intubation of intratracheal tubes. In the vast majority
of such complicating diseases and injury, the cause has been traced
directly to the employment of the cuff and the prolonged "tracheal
wall pressure" required for its use. As a partial tabulation of
such studies references can be made to the following articles;
Catane et al, British Journal of Anaesthesiology, 1969 Vol. 41,
page 1086; Grillo, H.C. Journal of Thoracic and Cardiovascular
Surgery, January 1969, Vol. 57, No. 1 page 52; Shelly et al,
Journal of Thoracic and Cardiovascilar Surgery, May 1969, Vol. 57,
No. 5 page 623; Fishman et al, Annals of Thoracic Surgery, July
1969, Vol. 8, No. 1, page 47; Miller et al, Annals of Surgery, Feb.
1970, Vol. 171, No. 2, page 283; and Westgate et al, Anesthesia and
Analgesia, May-June 1970, Vol. 49, No. 3, page 393. The result of
all the studies and findings in this field leads to the conslusion
that while intratracheal supply of ventilation is extremely
beneficial there is a need for an improved, less harmful
intratracheal tube with means for occluding the tracheal
passage.
It is the object of the present invention to provide an
intractracheal tube having occluding means which overcome the
drawbacks and dangers of the conventionally known devices.
It is another object of the present invention to provide a device
of the type described which is simple in construction and easier to
use.
It is another object of the present invention to provide apparatus
of the type described which has tracheal occlusion means not
requiring external inflation or maintenance in distended condition
by the application of external air pressure.
It is another object of the present invention to provide an
intratracheal tube having means for occluding the trachea operable
by and as direct result of the internal breathing process or as a
result of the applied auxiliary ventilating process.
It is a specific object of the present invention to provide a
device of the type described which permits prolonged intubation of
fluid feeding device without resulting in complicating side
illnesses etc.
These objects, and others, as well as numerous advantages will be
clearly observed from the following description of the present
invention.
SUMMARY OF THE INVENTION
According to the present invention apparatus for intubation within
body passages is provided comprising an elongated tube having an
opening at the distal end and means for connection to a source of
fluid, such as air, at its proximal end. Occlusion means is located
about the surface of the tube near the distal end to seal the space
between the passage and the tube against flow of air. The occlusion
means comprises a bag or canopy secured at its center, to the outer
surface of the tube being substantially open for receipt of air in
a direction toward the distal end of said tube. The canopy is
adapted to be distended against the inner surface of the passage to
form the required seal.
In the preferred form of the invention the canopy is bag like and
is open along its distal end or end facing the open end of the
tube, by providing it with a free edge radially spaced from the
tube to receive a sufficient amount of air flowing backward into it
so that it distends outwardly into contact with the surface of the
body passage wall. The bag or canopy is preferably, but need not be
integral with the tube itself, and can be held down at proximal the
end by some connection with the tube.
The canopy can be made of either inelastic or elastic material but
should be dimensioned so that in either case the canopy forms a
firm and secure seal with the walls of the passage when distended
without the need of excessive pressure to maintain it in that
condition.
In one form of the apparatus the free edge portion has a diameter
at least substantially equal to the diameter of the passage. In
another form the free edge may be of smaller diameter so that it is
prevented from contact with the surface of the passage.
The canopy may be spherical, cylindrical or conical in shape.
Preferably it has a dome portion through the center of which passes
the tube. The dome may be reinforced to provide it with a
deformable but recoverable shape.
The free edge of the canopy may also be provided with a plurality
of shroud lines which hold it to the tube somewhat like a
parachute, or it may itself be extended to.
The foregoing is only a summary of the present invention. Full
details of the invention and its preferred structural embodiments
is set forth below.
BRIEF DESCRIPTION OF THE DRAWINGS
The following disclosure makes reference to the accompanying
drawings in which:
FIG. 1 is a perspective view of the inventive occluding apparatus
embodied in an intratracheal tube,
FIG. 2 is an enlarged vertical section of the device showing the
canopy in use in a body passage such as the trachea,
FIG. 3 is a view similar to that of FIG. 2 showing a modified form
of the device,
FIG. 4 is a perspective views of a canopy showing modified dome
therefor,
FIG. 5 is view similar to FIG. 2 showing modified canopy having
accordion bellow walls,
FIG. 6 is a view of still another modification, and
FIGS. 7 and 8 are detailed views of a second embodiment of the
present invention.
Turning now to the drawings, the present invention is combined or
applied to an otherwise conventional intratracheal tube 10 which
may be made of rubber, plastic such as nylon, or even metal, such
as silver. Since the present invention does not require that the
tube be subject to high pressures, a silver tube is not necessary,
and the preferred material should be either rubber or plastic for
greater flexibility, control and lower cost. The distal or inferior
end of the tube is provided with the usual slanted edge 12 which
makes the insertion of the tube much easier. The proximal or
posterior end of the tube is provided with a connecting member 14
by which it may be made to communicate with a source of air. The
connecting member 14 is of the type common in tracheal ventilation
systems now in use.
The tube 10 can be made in varying lengths and of varying inner and
outer diameters as is the practice in this art. The source of air
(which is not shown) may be a tank and/or pump of any known type
supplied with or without valve means for delivering a continuous or
pulsating flow of air of regulated pressure and volume.
The trachea 16 as seen in the drawing is schematically shown; the
various details, such as the mucous lining and the cartilaginous
and membranous tissue of which it is composed being omitted for the
sake of clarity. The tube 10 is adapted to be inserted within the
trachea to extend in a direction from the larynx toward the
bronchus. Essentially the present invention is suitable as both an
endotracheal and as a tracheotomy tube and may therefore be
inserted naso- or oro-trachially or by incision through the throat
directly into the trachea below the larynx.
The details of insertion, as well as supply of air, pulsation,
humidification, and the full range of therapy involved are all well
known to those skilled in this art. Because of this and because
reference can easily be made to the studies and papers mentioned
earlier, such details are omitted here.
According to one form of the present invention the exterior of the
intratracheal tube is provided, as seen in FIG. 2, with occluding
means comprising a canopy generally depicted by the numeral 18,
located near the distal end 12. The canopy is generally formed by a
bag of cylindrical shape having a symmetrical wall 20 ending in a
circumferential free edge 22 forming an open facing the lungs and
at its posterior end in an enclosing dome wall 24, cephalad. The
dome wall 24 is provided with a central hub 26 which surrounds and
is integrally secured, adhered, or formed with the exterior surface
of the tube 10.
Preferably, the canopy 18 is made of inelastic or slightly elastic
plastic or synthetic material inert to the body fluid and
chemistry. Material such as polyurethane, polypropylene, surgical
rubber, or silicon rubber such as that sold by Dow-Corning under
the Trademark "Silastic" are all suitable. The canopy as will be
explained later is not required to be expanded or blown up as a
rubber balloon in the fashion of the prior art "cuff" but is merely
distended to assume a fixed shape under pressure of the ambient or
moving air within the trachea. Consequently, elasticity of the
material is not required. Although it is, on the other hand, not a
detriment or hindrance to good working of the device.
In the embodiment shown in FIG. 2 the canopy wall is generally
cylindrical and has an outer diameter at least substantially equal
to the diameter of the trachea lumen or passage. The shape of the
wall 20 is not critical nor is its length, however, in this form an
important feature resides in the fact that the diameter of the
circumferential free edge 22 or canopy wall 20 must be sufficient
to lie, when the bag is filled with air, against the inner mucous
walls of the trachea 16. The diameter of the edge 22 or canopy 20
may be larger than the inner diameter of the trachea since a
certain degree of overlap of the material forming the wall 20 is
permissible, however, it should not be smaller since air may pass
between it and trachea wall leaking outwardly of the trachea. The
axial length of the wall 20 should also be sufficient to engage and
abut against the inner walls of the trachea for a sufficient
distance to provide a sealing area of sufficient size so that small
creases, folds, pockets, or voids in either the wall of the bag of
in the wall of the trachea are completely covered and sealed.
As is known, the trachea itself has an oval cross section and
consequently while cylindrical circular cross sectioned canopies
may be simple to construct, the canopy may be ovaloid, elliptical
in cross section, or any other shape. The flexibility and
distendibility of the material used will enable the canopy to
conform to the shape of the trachea.
The shape of the wall 20 may be somewhat modified in the form of a
sphere, however, in accordance wth the form shown in FIG. 2 the
overall outer diameter of the free edge should be of the size at
least substantially equal to the diameter of the passage.
The canopy shown in FIG. 2 may be embodied in a number of ways. For
example in FIG. 3 the canopy is provided with a plurality of
conically arranged shrouds or strips 28 which function to hold down
the free edge 22 during insertion of the tube in the body passage.
The shrouds lines may be formed of the same material as the canopy
18, and are integrally connected to the free edge 22 and the outer
surfac of the tube 10. Preferably, the length of each is equal to
that of the others and greater than a straight line drawn between
the surface of the tube 10 and the inner surface of the trachea at
the points where the ends of the shrouds 28 contact. The shrouds or
strips 28 permit the intratracheal tube 10 to be inserted in the
trachea without the aid of a Penrose drain or other covering means
and yet be assured that the free edge 22 will not curl, ravel or
invert. The extra length of the shroud will however, insure that
the free edge or canopy wall distend completely to the wall of the
trachea.
In FIG. 4, the canopy is shown as formed with a plurality of
concentric rings 30 imbedded in the dome or bottom wall 24, the
concentric rings provide a constant canopy structure with spread
walls 20 which depend freely therefrom. This construction provides
an always open canopy which is pressed toward the wall of the
trachea by only a minimal differential in air pressure. The rings
may be rubber, plastic, or metal although soft deformable plastic
is preferred.
The dome 24 may be also formed with a plurality of radially
arranged spokes which function similarly to the rings 30 of FIG. 4,
although they are deformable in a different manner. The canopy dome
may be made of a greater thickness to provide suitable
firmness.
In FIG. 5 still another form of the present invention is shown in
which the canopy is formed similar to that of a bellows having a
wall 30 formed of a circumferentially arranged longitudinally
extending alternating series of inward and outward pleats 32. As
seen in FIG. 5, the bellows has a proximal collar 34 which is
attached in sealed condition about its center to the tube 10 in the
manner previously shown.
In FIG. 6 still another form is shown wherein the tube 10 itself is
provided with one or more small holes 40 extending radially through
its wall and directed toward the side walls 20 of the canopy 18.
Such holes permit the escape of small amounts of air against the
side wall 20 during inspiration creating a positive pressure
against it and forcing it securely against the mucous lining of the
trachea. If desired, the provision of the holes 40 permits suction
to be applied to the tube, drawing in the walls 20 against the
tube. Th intubation of the tube may then not require a cover such
as the Penrose drain or it may be useful as a means of controlling
by-pass of air should therapy so require it.
In FIGS. 7 and 8 still another form of the present invention is
shown. In this embodiment the canopy 42 has a generally bulbous,
onion like conical configuration. The tube 10 passes through a
collar 44 at the apex of the cone whidh is integrally sealed or
secured within any of the prior forms to render the canopy sealed
against passage of air. As seen in FIG. 7, the free edge 46 is
rolled or hemmed to provide a reinforced edge which has only
limited elasticity relative to the remainder of the canopy. The
rolling or hemming of the free edge can be simply obtained when
plastic or rubber material is used by gluing or heat sealing.
Unlike the prior forms the present canopy 42 is provided with a
free edge 46 which may be narrower in diameter than the diameter of
the body passage 16. Because the edge is rolled or hemmed it has
limited elasticity preventing it from contacting or engaging the
inner surface or lining of the body passage. When air, however,
fills the canopy, the conical wall portions distends upwardly and
outwardly and the central peripheral surfaces thereof contact the
lining walls effecting the occlusion of the passage. The free edge
maintains its circular cross section even when the canopy is
extended, permitting only the conical wall to distend creating
curved contacting surfaces with the lining of the trachea, as seen
in FIG. 8.
While the canopy in this embodiment might have some degree of
elasticity it is not absolutely necessary. The elasticity would
allow the canopy to bulge and form the contacting engagement.
However, the same bulge can be made with an inelastic material
since the conical canopy has a slightly bowed or curved vertical
cross section.
In the embodiment shown in FIG. 7, a plurality of shroud lines 48
may be provided to hold the peripheral free edge 46 taut. Since,
the free edge is not intended to be elastic or even to distend, the
lines 48 may be of a shorter length than required in the form
illustrated earlier. In fact, the lines 48 can be so short as to
extend radially, like spokes in the plane of the free edge. The
lines 48 may be secured by a circular band 50 sealed to the tube.
The shrouds act to hold the edge 46 and to force the creation of
the roll or bulge in the conical bag.
In any event the overall circumference or diametrical dimension of
a canopy employing an inelastic hem or free edge must be
substantially equal to the diameter of the body passage so that
when it is distended it will occulde the passage. Excess pressure
on the surface is to be avoided as well as the need to extend the
canopy beyond elastic limits. An advantage of this embodiment over
the preceding one lies in the fact that the free edge portion does
not contact the lining of the body passage and consequently a
resilient or elastic material may be used without fear that its
free edge will cut into the wall. In some body passages the elastic
canopy may be preferred since it will more easily conform to the
irregular mucous linings.
The devices of the present invention are indeed very simple and in
this simplicity lie the benefits and advantages not obtained by the
prior art. Operatively the device such as the intratracheal tube is
inserted within the trachea in any one of the known ways previously
discussed. For ease of insertion a Penrose drain may be used to
surround the tube which is later removed once the tube 10 is fully
inserted. Once intubation is accomplished the connector 14 is
attached to the source of air and ventilation begun. In the
inspiration portion of the ventilation cycle, air is supplied to
the patient at a pulsating rhythm, pressure, and volume desired for
proper therapy. The air passes through the tube exiting from the
distal end 12 in the direction of the arrow A(FIG. 2) toward the
bronchus. Since air like all fluid tends to take multiple paths,
particularly the one of least resistance, a certain amount of air
bends upwardly and flows axially along the outer surface of the
tube 10. The upwardly flowing air enters into the canopy and opens
it radially outwardly. In the forms of FIGS. 2 and 3 the wall 20
engages the inner surface of the trachea 16, since the free edge 22
has a diameter at least equal to the inner diameter of the trachea.
Any amount of air within the bag having a differential or .DELTA. P
greater than atmosphere will force the canopy to lie snugly and
securely about the entire circumference of the inner wall of the
trachea. Air thereafter completely fills the bag of the canopy
forcing the axial extend of wall 20 against the mucous surface
preventing passage of air or leakage during the inflow portion of
ventilation cycle. During the expiration portion of the ventilation
process, the patient either voluntarily or forcibly exhales air in
a stream labeled by the arrow B. The exhalation portion of the
cycle is not under forced or positive inward pressure. This lack of
pressure in the conventional intratracheal tubes would, but for the
independent inflation of the cuff, cause a collapse of the seal
between tube and trachea surface. Here, however, the reverse flow
of air B passes in a major stream upwardly through the tube 10 and
in a minor stream about the outer surface of the tube 10 into the
canopy. The exhaled air functions similarly to the inflowing air to
fill the canopy and maintain the wall 20 firmly pressed against the
inner wall of the trachea.
The ventilation cycle produces a generally sine-wave flow of air in
which, during the inspiration cycle a flow of air occurs in one
direction, while in the expiration of the cycle a flow of air
occurs in an opposite direction. At an instant of time the flow of
air may be at a standstill or zero value (i.e. between the forward
and reverse flow), and the canopy relaxes from its distended
position receding from the surface of the lining. This has a
beneficial effect in that it positively avoids prolonged blockage
of capillary blood flow and ischemia, should it ever occur. The
canopy itself, takes on a modified pulsation responsive to the flow
of air rhythmically distending and receding. This has a benefical
effect on the lining of the passage since at the zero pressure
period, the surface of the passage is instantaneously free of
pressurized contact with the canopy. The periodic deflation is
automatic and responsive to the rhythmic ventilation and obviates
the need for the hourly relaxation of the "cuff" and shutting down
of the ventilation process. Notwithstanding this rhythmic
deflation, the canopy does not collapse, so that effective
occlusion is never lost. The passage remains effectively blocked
because of only the instantaneous relaxation.
Notwithstanding the open end of the canopy, the bag 18 as shown in
FIG. 2, will not reverse itself under the pressure of either air
stream A or B. The surface tension between the bag and the mucous
lining of the trachea 16, together with the size and diameter of
the bag, prevent inversion of the bag. The canopy, shown in FIG. 3
and FIGS. 7 and 8 having shroud lines or being secured to the tube
at the distal end, cannot invert or reverse itself, under any
condition.
The canopy shown in FIGS. 7 and 8 operate much in the same way as
those shown in FIGS. 2 and 3, for example. Here the inextensible
edge or rolled hem prevents the canopy from distending along its
entire length. However, the flexing of the canopy itself and the
distending of the walls provides ample sealing surface. The conical
shape and smaller diameter distal end secured to the tube by short
shrouds forms a more cohesive unit which can be handled with great
ease without fear of harming the device itself. It also enables the
device to be inserted within the body passage with greater ease and
without the use of drains, etc. The conical shape and the outward
and upward distending of the canopy seems also to provide a more
secure seal and occlusion.
A startling advantage arises from all forms of the present
invention, in that the low pressure necessary to distend the canopy
is equal to ventilatory pressure and the pressure within tube 10.
Therefore, since all pressures are substantially equal, the tube
need not be made of the heavy, thick wall or strong tubing required
by the prior art to prevent intratube occlusion but may, in fact,
be made of a soft pliable thin walled material. Such material is
more comfortable to the patient, and permits easier intubation.
Further advantages and forms of the invention will be observed.
Various circumferential levels of the canopy can be provided with
different thicknesses so as to be more or less extendible and more
or less rugged. Thus, for example, the canopy, as seen in FIGS. 7
and 8, can have its dome 44 formed of a thicker material and with
its central equatorial section, denoted by the dotted lines of
lesser thickness, so that the dotted equatorial portion may be more
readily distended into contact with the surface of the body
passage. This can be easily accomplished when forming the invention
of plastic or rubber by known dipping or molding techniques.
Among the various alternatives possible, are the numerous
combinations and permutations available from the forms earlier
shown. For example, the entire conical canopy 42 of FIGS. 7 and 8
can also be made with pleats in the form of the bellows shown in
Fig. 5, or the pleats may be the equatorial portion only. The
conical bag may be made also to extend distally to the tube as a
unitary piece and the shrouds formed by cutting holes in the bag to
open the bag to incoming air. The earlier shown forms may be
provided with rolled or hemmed free edges, of either smaller
diameter or equal diameter, to the body passage. Any of the
embodiments may be provided with reinforced domes or side walls.
Other combinations will now be apparent.
The present invention has been described as being integrally
constructed on the surface of an endotracheal tube. It will be
appreciated that it can easily be formed as a separable member, by
converting the tube 10, shown in each of the embodiments, into a
sleeve of finite length. The sleeve, which can be relatively thin
rubber, plastic or even metal, is then adaptable to be slid over
the end of an existing endotracheal tube of either the flexible
plastic or rubber type or over the inflexible sliver type.
Functioning of the device, of course, remains the same. It will
also be appreciated that the present device can be used with a
conventional "cuff" as an auxiliary or iniating occlusion device as
may be desired.
It will thus be seen that the present device functions entirely
differently than the prior art devices. In the first place the
canopy is always open and is not inflated independently. Secondly,
the bag does not assume the shape of an annular balloon or toroidal
ring. In fact the present bag takes the form more closely
approximating that of a parachute and is inflatable or openable
only on the passage of air into its open end. Thirdly, the opening
of the bag is not dependent upon overcoming any residual elasticity
of its material. In fact, the elasticity of the bag plays little or
no part at all in its structural formation or in the creation of
the seal itself. Fourthly, the canopy is not maintained in open
position by the superimposition of an independent volume or
pressure of air. The intra bag (intra-cuff) pressure is exactly the
same as that pressure exerted by the inhaling air stream A and the
exhaling air stream B, both of which are more natural to the
patient than any pressure employed in inflating the prior cuffs of
the prior art. Above all, the sealing pressure, required to make
the perfect seal is also equal to the pressure of the flowing
streams A and B and is not in excess to the normal pressure exerted
against the mucous linings. The pressure required to inflate or
distend the canopy is only at a level slightly above atmosphere
(i.e. the .DELTA. P between the air in the trachea and the
atmosphere is only very small) the actual pressure exerted by the
present device on the surface of the passage should not exceed 30
cm/H.sub.2 O. This pressure is well below the pressure which blocks
capillary blood flow and therefore ischemia is obviated. The
pulsation of the canopy also prevents blood stoppage.
Laboratory tests performed with dogs have been made over a long
period. These tests have shown successful use of the device.
Curarized dogs have been maintained with the present device for
periods exceeding 10 hours at pressures of between 15 - 20
cms/H.sub.2 O, at tidal volume of 400-500 cc with no significant
leakage. Ventilatory support for 72 hours produced no visible gross
or even microscopic tracheal damage. Similar tests, but over a
prolonged period of ventilation, continue to be carried out,
current indications are that positive respiratory assistance can be
obtained over indefinite periods without tracheal damage or with
only minimal and largely insignificant damage.
There are but a few of the embodiments to which the present
invention may be applied. Numerous others will now be readily
apparent to those skilled in this art. The essential feature of
each embodiment is the canopy construction which has a free edge
defining an open end directed toward the lungs and an enclosed dome
cephalad whereby the air inherent in the procedure is employed to
distend the canopy and maintain it in sealed position against the
wall of the trachea.
Having described the present invention it will be also obvious that
the objects set forth for it have been met. The present device is
simple and of low cost. The present device is safer and less
injurious to the body than the prior art. The present device
provides a safe and effective occlusion means without the use of
excess pressure. The present device does not require external air
pressure to maintain its sealing pressure. Furthermore, the present
device enables prolonged intubation.
Since various changes, modifications, equivalent structures may be
employed, it is intended that the present disclosure be
illustrative of the invention and it should therefore not be taken
in any limiting or restricting manner.
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