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BACKGROUND OF THE INVENTION
The present invention relates to medical-surgical devices for intubation,
and in particular to endotracheal or other tubes intended to be inserted
within the trachea of a patient for effecting artificial ventilation in
surgical treatments requiring general anesthesia or in intensive
resuscitation treatments.
In surgical treatments requiring general anesthesia and in intensive
resuscitation treatments, it is frequently necessary and advisable to
subject a patient to laryngotracheal anesthesia and/or anti-inflammatory
and mucolytic treatments localized at the place of traumas resulting from
the intubation or from the introduction of a foreign body constituting the
endotracheal tube.
In accordance with a known technique, the administration of local
anesthetics, anti-inflammatory and fluidizing drugs is effected by
insertion of a suitable cannula into the trachea of the patient before
intubation with the endotracheal tube, the cannula being then removed to
permit the introduction of the tube. However, once the endotracheal tube
has been inserted, the administration of drugs consisting of local
anesthetics, anti-inflammatories and mucolytics cannot be repeated.
In fact, the endotracheal tubes in accordance with the prior art are
differently shaped and devised as well as provided with many necessary
devices such as secondary canalizations for various purposes, but none
specifically intended for the effective administration of drugs such as
local anesthetics, anti-inflammatories and fluidizers with constant
intubation.
OBJECTS OF THE INVENTION
A main object of the present invention is therefore to provide a modified
endotracheal tube that permits the repeated administration of drugs such
as local anesthetics, anti-inflammatories and mucolytics, even during
intubation of such tube in such manner as to attain a prompt
laryngotracheal topical anesthesia or an anti-inflammatory action in said
anatomic structures which is reproducible and that avoids reducing the
pharmacological effectiveness covered by a previous administration.
Another object of the present invention is to achieve the above object with
optimal diffusion of the administered drugs.
Still another object of the present invention is to achieve the previous
objects through a device that does not impede intubation by the modified
endotracheal tube, or in any way make it more complicated for the
operator, or more traumatic for the patient.
A further object of the present invention is to attain the above objects by
a device that, furthermore, avoids interfering with the functions of the
endotracheal tube with which it is associated.
SUMMARY OF THE INVENTION
The foregoing and other objects are obtained through an endotracheal tube
particularly intended for artificial ventilation in surgical operations
and intensive resuscitation treatments in accordance with the present
invention. The inventive tubes comprise independent secondary canalization
for the repeated administration and passage of drugs--particularly local
anesthetics, anti-inflammatories and mucolytics--during the course of
intubation. In this connection, the inventive tube is provided with a
distal end that is associated externally with the endotracheal tube and is
suitable for spraying said drugs through a plurality of micrometric
openings. Such distal end can debouch into similarly perforated chambers
developed on the outside around the distal segment of said endotracheal
tube.
BRIEF DESCRIPTION OF THE DRAWINGS
Further characteristics and advantages of the device in accordance with the
present invention will become apparent from the following detailed
description of certain of its embodiments which are preferred but not
exclusive, and given by way of illustration and not of limitation, in the
accompanying drawings, in which:
FIG. 1 shows a longitudinal length of an endotracheal tube comprising an
irrigation device according to the present invention;
FIGS. 2 and 3 show two cross sections, respectively, through the
endotracheal tube of FIG. 1 taken at lines A-Al and B-B1 in FIG. 1,
respectively;
FIGS. 4, 5 and 6 show the distal portion of an endotracheal tube associated
with three respective, alternative embodiments of the irrigation device of
the invention;
FIG. 7 shows a longitudinal length of an endotracheal tube comprising
another alternative embodiment of the irrigation device of the invention;
FIGS. 8, 9 and 10 show respective cross-sections through the endotracheal
tube of FIG. 7 taken at lines A-A1, B-B1 and C-C1 in FIG. 7, respectively.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to the figures and, in particular, to FIG. 1, the numeral "1"
indicates, in general, an endotracheal tube of plastic material for
artificial ventilation of known type (except for details specifically
illustrated which constitute the invention). The endotracheal tube 1
comprises a main tubular structure 2 provided at one end (proximal end)
with a coupling 3 for connection to an automatic respiration system of
known type (not shown), and at the other end (distal end) with a balloon
4, also of known type, adapted to be inflated by air in order to adhere to
the trachea of the patient and to be used for known functions.
The air for the inflation of the balloon 4 is fed to the latter through a
secondary flexible canalization or inflation cannula 5 of plastic material
which extends along and is developed on the inside of the main tubular
structure 2, adhering to the inner wall of the latter, or preferably
within the thickness of the wall itself. The cannula 5, emerges near the
proximal end of the main tubular structure 2 itself, and is associated
with a coupling 6 for connection to a flow-generating system.
Towards the proximal end of the main tubular structure 2 there also
commences another secondary flexible canalization or irrigation cannula,
indicated generally as 7. Cannula 7 is also formed of plastic material and
is of constant cross-section in its three sections of development
described below. Cannula 7 is also equipped at its proximal end with a
coupling 8, provided with pin 9 that is adapted to be associated with a
syringe or hypodermic syringe (not shown).
The irrigation cannula 7, which constitutes an aspect of the present
invention, is developed over its first portion or proximal portion 10 on
the outside of the main tubular structure 2 without adhering to it. The
irrigation cannula 7 is inserted into the main tubular structure 2 and has
a second or central portion 11 extending within the main tubular structure
2 and adhering to the inner wall of the latter or being within the
thickness of the wall itself; alternatively, it may extend within
structure 2 in the same way as the inflation cannula 5; see also FIG. 2,
which is a cross-section taken at said line A-A1 in FIG. 1.
Finally, the irrigation cannula 7 emerges from main tubular structure 2 and
extends, over a third or distal portion 12, along the outside of the main
tubular structure 2 while it adheres to the outer wall of the distal
section of the latter, and even beyond the balloon 4, and terminates with
a rounded closed-end 13; see also FIG. 3 which is a cross-section of the
unit in this distal section along the line B-B1 of FIG. 1.
The third or distal portion 12 of the irrigation cannula 7, which portion
constitutes a true spray device, is provided over its entire length and
surface with a plurality of micrometric or small holes 14 for placing its
interior side in communication with the outside.
In the variant embodiment shown in FIG. 4, in which only the distal section
of the endotracheal tube is shown, the perforated distal portion 12 of the
spray cannula 7 debouches into a chamber described and limited by a casing
15. The casing surrounds on the outside, and wraps around so as to
enclose, the balloon 4 of the endotracheal tube 1; it is fastened to the
latter by upper 16 and lower 17 cuff portions thereof. The outer casing 15
is also provided over its entire surface with micrometric or small holes
14 for placing its interior in communication with the outside. The casing
15 preferably constitutes silicone with high stretchability, even by a low
pressure force.
In the variant embodiment shown in FIG. 5, in which there is also shown
only the distal section of the endotracheal tube 1, the perforated distal
portion 12 of the irrigation cannula 7 stops and terminates with its
rounded portion 13 upstream of the balloon 4 of the endotracheal tube 1.
In the variant embodiment shown in FIG. 6, in which there is also shown
only the distal section of the endotracheal tube 1, the perforated distal
portion 12 of the irrigation cannula 7 debouches into a ring-shaped
chamber provided within a cylindrical cuff 18 with double walls welded
together at the bases; cuff 18 surrounds the endotracheal tube 1. The
cylindrical cuff 18 is also provided over all of its own outer surface
with micrometric or small holes 14 adapted to place the ring-shaped
chamber described by it in communication with the outside; cuff 18 is
formed preferably of silicone, and is preferably arranged in
non-protruding fashion on the outer surface of the endotracheal tube 1,
fixed around tube 1 by a suitable groove provided on the endotracheal tube
1 itself.
FIG. 7 shows another alternative embodiment of the endotracheal tube
according to the present invention, in which the irrigation cannula 12
(FIG. 1) is split into two proximal portions 10 and 10A outside the main
tubular structure 2; such portions 10 and 10A are engaged within the
structure 2 and extend in two portions 11 and 11A within the thickness of
the wall of said main tubular structure 2, like the inflation cannula 5 of
the balloon 4; see also FIG. 8 which is a cross section through the entire
unit in said section along the line A-A1 of FIG. 7.
The first inner branch 11 of the irrigation cannula 7 debouches into a
ring-shaped chamber contained within a first cylindrical cuff 18 located
proximally with respect to the balloon 4; such cuff 18 has the same
characteristics as that described above and bearing the same number in
FIG. 6; and, for instance, is also provided with a plurality of
micrometric or small holes 14 on its own outer surface; see also FIG. 9
which is a cross-section through the entire unit in this section along the
line B-B1 of FIG. 7.
The second inner branch 11A of the irrigation cannula 7, however, continues
beyond the balloon 4, below it, and debouches into a further ring-shaped
chamber provided within a second cuff 19 located distally with respect to
the balloon 4. The cuff 19 has the same characteristics as the cuff 18
referred to above and is also provided with a plurality of micrometric or
small holes 14 on its outer surface; see also FIG. 10 which is a cross
section of the entire unit in said section, along the line C-C1 of FIG. 7.
In operation, an endotracheal tube 1 is used in known manner to intubate a
patient; after the intubation has been effected and at some time during
the surgical operation or the intensive resuscitation treatment, the
patient can be administered or re-administered a dose of a drug, broadly
defined to include local anesthetic, anti-inflammatory or fluidizer
intended to carry out its action locally on the laryngotracheal mucosa;
this may occur possibly after inflation of the endotracheal balloon 4 in
order to permit contact of the drug also with the underlying tracheal
mucosae. This administration is effected by injecting, with a syringe a
hypodermic syringe, a suitable dose of drug into the irrigation cannula 7
through the coupling 8.
The drug which is thus injected reaches, through the proximal portion 10
and medial portion 11 of the irrigation cannula 7, the distal portion 12
thereof and, from the latter, emerges sprayed through the holes 14, so as
to expand on the laryngotracheal mucosae, irrigating them and carrying out
its intrinsic action.
In the variant embodiment shown in FIG. 4, the drug enters into the
external casing 15 and emerges from the holes 14 provided on the surface
thereof, resulting in a more uniform distribution over the entire tracheal
mucosae. The perforated outer casing 15 does not prevent the functional
expansion of the underlying balloon 4 of the endotracheal tube 1 owing to
the substantial elasticity which characterizes it; nor does casing 15
constitute an impediment to intubation as it does not extend substantially
beyond the profile of the endotracheal tube 1, like the underlying balloon
4, when deflated.
In the variant embodiment shown in FIG. 5, the perforated distal portion 12
of the irrigation cannula 7 is shorter in order not to interfere with the
expansion of the balloon 4 of the endotracheal tube 1.
In the embodiment shown in FIG. 6, the drug reaches into the ring-shaped
chamber formed by the cuff 18 and emerges as spray through the holes 14 to
achieve a more homogeneous diffusion over the entire endotracheal mucosa.
In the embodiment shown in FIG. 7, the drug is distributed in the two
branches 11 and 11A of the irrigation cannula 7, and from the latter
enters into the ring-shaped chambers respectively formed by the upper cuff
18 and lower cuff 19. The drug emerges as spray from the holes 14 to
achieve an even more diffuse irrigation of the mucosa.
It is obvious that the shaping and location of the irrigation chambers,
when provided, can differ from those illustrated above, subject to the
concept of the solution described above and claimed below; thus, subject
to the same concept of solution, the conformation of the spray holes can
also be different; for instance with a spiraling course on the distal
portion of the spray cannula, which latter can furthermore be provided
with internal spirals or the like in order to impart turbulence to the
flow the drug.
It is obvious, finally, that subject to the preferred use of the invention
in the field of endotracheal tubes, the spray device of the present
invention can find useful and functional application also in
medical-surgical tubes and catheters having different functions.
As is evident from the above description of preferred, but not exclusive,
embodiments, the spray device of the present invention advantageously
provides a means permitting the administration of, possibly repeated
administration of, and a homogenous diffusion of, drugs of the type
including local anesthetics, anti-inflammatories and mucolytics with
constant intubation with endotracheal tube. Such provision of drugs occurs
without substantially complicating the intubation or making it more
traumatic for the patient; for instance, the overall structure of the
instrument is not made in any way rigid, nor is the corresponding cross
section changed; furthermore, the drug administrative is achieved without
interfering with the functions of the endotracheal tube with which it is
associated.
Moreover, the possibility afforded by the invention of repeating the
topical anesthesia with constant intubation results, in the course of
general anesthesias, in an appreciable savings of neuroleptics,
analgesics, halogenated gaseous anesthetics and, in particular muscle
relaxants; as well as in permitting the subjecting to general anesthesia
of patients who are otherwise inoperable or subject, at times, to lethal
post-operative complications.
In addition, there are eliminated or substantially reduced complications of
protracted intubations such as dysphonia, laryngitis and formation of
mucus plugs, thereby improving the tolerance to respiratory prosthesis as
well as the quality of the post-operative wakening and of the period
following the extubation.
Furthermore, in the treatments of patients subjected to intensive
resuscitation therapy, the adaptation of such patients to the endotracheal
tube and, through it, to an automatic respirator is frequently permitted
by repeated administrations of tranquilizing drugs, analgesics, muscle
relaxants and halogenated gaseous anesthetics. With the spray device
according to the present invention in such operations, in addition to
considerably reducing the dosage of such drugs, local complications such
as cardiovascular complications are reduced and, in particular, there can
be reduced the recourse to a tracheostomy as a consequence of repeated
traumatisms of the balloon of the endotracheal tube on the mucosae.
It should be understood that the preferred embodiments and examples
described are for illustrative purposes only and are not to be construed
as limiting the scope of the present invention which is properly
delineated only in the appended claims.
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