Note: Descriptions are shown in the official language in which they were submitted.
WO 95132017 ~ ~ 9 ~ 19 9 p~~g95/06403
APPARATUS FOR PRODUCING A TRANSLARYNGEAL TRpCHE~~mnrav
Description
~ The present invention relates to an apparatus for producing
a translaryngeal tracheostomy.
It is known that tracheotomy is normally performed in an
operating theater in aseptic conditions with the aid of an
assistant, an anesthesiologist, and a scrub nurse.
The patient is placed in the dorsal position, with the head
in hyperextension with a cushion under the shoulders to
exteriorize the laryngotracheal region.
To perform tracheotomy, a cutaneous incision is performed
that includes the skin, the subcutaneous cell tissue, and the
cutaneous muscle. The incision is approximately 4 cm long and
is performed along a horizontal line at the upper margin of-the
jugular fossa; optionally, the incision can also be performed
vertically along the median line, starting from thecricoid
cartilage and continuing downward for 3-4 cm.
The vertical incision has the advantage that it does not
cross the surface veins, but it leads to a more conspicuous scar.
In conventional techniques, therefore, in order to perform
tracheotomy it is necessary to perform an actual operation, with
all the difficulties and contraindications typical of this
procedure.
The aim of the present invention is to provide an apparatus
for producing a translaryngeal tracheostomy that allows, instead
of performing an operation, to insert, according to a new
technique, a tracheostomy tube which in practice is bloodless and
most of all does not require the incision of skin or muscle
tissues, thus ehm~natlrig the times and probl~ns linked to cicatrization.
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Within the scope of the above aim, a particular object of
the invention is to provide an apparatus that allows to apply the
tracheostomy tube from the inside outward, radically modifying
the techniques used so far.
Another object of the present invention is to provide an '
apparatus that allows to produce a tracheostomy, avoiding an
operation and all complications such as hemorrhages, infections,
large and unaesthetic scars, and the like, which are normally
linked to an operation.
Another object of the present invention is to provide an
apparatus that allows to apply the tracheostomy tube in
considerably less-time than conventional methods.
This aim, these objects, and others which will become
apparent hereinafterare achieved by an apparatus for producing
a translaryngeal tracheostomy, -according to the invention,
characterized in that it comprises: a trocar that can be inserted
in an interannular space of the trachea, from the outside inward;
a traction wire which can be inserted in said trocar to move its
end outside the oral cavity; a tracheostomy tube which is
provided with a substantially conical end in which said end of
said traction wire can be inserted; and enlargement means which
can be fixed to said end of said traction wire to insert said
tracheostomy tube in the trachea and to make it exit from said
interannular space by means of traction applied to said traction
wire from the other end.
Further characteristics and advantages will become apparent
from the description of some preferred but not exclusive
embodiments of an apparatus for producing a translaryngeal s.
tracheostomy, illustrated only by way of nonlimitative example
in the accompanying drawings, wherein:
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figure 1. is a schematic sectional exploded view of the
tracheostomy tube and of the parts related to it;
" figure 2 is a view of the tracheostomy tube, assembled for --._
insertion, in a first embodiment;
figure 3 is a view of the tracheostomy tube with a
rigid penetration cone;
figure 4 is a view of the tracheostomy tube in which the
penetration element is formed by multiple cones;
figure 5 is a view of the initial step for the
insertion of a rigid cannula with a bronchoscope;
figure 6 is a view of the step for the insertion of the
trocar;
figure 7 is a view of the step for the insertion of the
traction wire;
figure 8 is a view of the insertion of the traction
wire and of the exit of its end from the oral cavity;
figure 9 is a view of the step for connecting the
traction wire to the tracheostomy tube;
figure 10 is a view of the exit of the tracheostomy
tube from the interannular region of the trachea;
figure 11 is a view of the removal of the penetration
element of the tracheostomy tube;
figure 12 is a view of the arrangement of the
tracheostomy tube in the trachea;
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figure 13 is a schematic perspective view of a tool for
pulling the traction.-wire;
figure 14 is a view of the tool assembled at the end of the
step for the _.extraction of the penetration element of the
tracheostomy tube. _..
With reference .to the above figures, the apparatus for
producing a translaryngeal tracheostomy, according to the
invention, comprises a rigid cannula 1, provided with an
inflatable sleeve 2, that can be inserted in the trachea 3. The
cannula 1 can be coriiiected to the ventilation unit to keep the
patient correctly ventilated.
The rigid cannula is provided, in a per se known manner,
with an elastic plug 5 for inserting a bronchoscope 6 without
allowing gas to escape, thus maintaining the continuity of the
ventilation of the patient.
The bronchoscope 6 is placed inside the cannula 1 and allows
to identify the interannular space, which is generally designated
by the reference numeral 10. Lighting isperformed by moving the
cannula 1 forward towards the front wall of the trachea 3, so
that the beam of fight projected by the bronchoscope allows to
identify the region 10 from outside by transillumination.
A trocar 11 can be inserted in the interannular region 10
and is inserted from outside towards the inside of the trachea,
at a downward angle, towards the illuminated region, so that the
needle enters, as shown in figure 6, the cannula 1, from which
the bronchoscope 6 .can now be removed.
The trocar 11 acts as guiding element for a traction wire
20 which is inserted so that by passing through the cannula 1 it ,
can easily exit from the oral cavity with its end.
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Once the traction wire has been positioned, the cannula 1
and the trocar 11 are removed, thus achieving the condition shown
in figure 8.
The end of the traction wire 20 is inserted in z
5 tracheostomy tube, generally designated by the reference numeral
30, which is constituted by a tubular element 31 which has an
inflatable sleeve 32 at one end and, at the other end, a
penetration element which is generally designated by the
reference numeral 35.
The inflatable sleeve 32 is connected to an air supply tube
32a which during the insertion step; as clarified hereinafter,
is placed inside the tubular element 31 and can subsequently be
removed to connect. it to the pumping element 32b.
The penetration element 35 is constituted, as shown in
figures 1 and 2, by a fixed cone 40 which is placed at the end
of the tubular element 31 and on which a flexible cone 41 is
associated, for example by gluing; said cone has a metal insert
42 at the penetration tip.
In this manner, one obtains a low-taper penetration element
that produces a gradual divarication as it enters the
interannular region.
The penetration element 35, as shown in figure 3, can also
be obtained by means of a single rigid cone, optionally made of
metal or covered with metal, designated by the reference numeral
50, which is located at the end of the tubular element 31 and has
a larger taper angle, producing a faster type of divarication.
According to another embodiment of the penetration element
35, shown in -figure 4, there are multiple cones 55 which have
progressively larger dimensions and are arranged sequentially
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with respect to the traction wire 20 that joins them.
The traction wire 20 has, at the end where-the tracheostomy
tube 30 is located,-enlargement means which have the purpose of -
preventing the disengagement of the traction wire 20 from the
tracheostomy tube when traction is applied to the wire in order ' -
to make the penetration element 35 produce a gradual expansion
of the interannular region 10, consequently causing the exit of
the tracheostomy tube, which is inserted from the inside outward.
The enlargement means can be provided in various manners and
can be constituted by a first retainer 60, which is fixed
directly to the end of the wire and can be inserted in the trocar
11 during the initial step and on which a cup 61 and an elastic
ring 62 are applied, preventing disengagement, once the wire has
been inserted in the tracheostomy tube.
I5 It is optionally also possible to provide an element that
can be coupled to the first retainer 60 so as to increase its
size and prevent extraction.
Furthermore, if one wishes to use a smaller trocar, it is
possible to provide no enlarged portions on the wire and to
couple to said wire, once it has been inserted in the
tracheostomy tube, a small strip which can be folded in the shape
of the letter U so as to in practice enlarge the end of the wire,
preventing its accidental extraction, even when the traction wire
is pulled. - _ _
Of course it is possible to use other elements that allow
to enlarge the end--of -the traction wire after it has been
inserted in the txacheostomy tube, such as for example a knot in
the wire_ -
Once the penetration element has been made to exit from the
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interannular region IO by means of the traction wire, the
penetration element 35.is removed by cutting and the inflation -
duct 32a is connected to the pumping element 32b; after directing
" the loose end of the tracheostomy tube 30 towards the pulmonary
region, the sleeve element 32 is inflated, thus allowing to
' ventilate the patient.
In this manner the tracheostomy tube is therefore applied
from the inside outward and most of all without having to perform
an operation that causes bleeding but by simply obtaining a
gradual divarication of the interannular region where a very
small hole has been formed by means of the trocar.
In order to facilitate the application of the tracheostomy
tube, and in particular in order to be able to apply correct
traction to the traction wire 20, a tool 70 is provided; said
tool is shown in figures 13 and 14 and consists of a base body
71 which has a plate 72 that can rest at the outer surface of the
trachea in the region where the wire 2 exits. The plate 72 is
provided with a passage hole 73 which is larger than the diameter
of the tracheostomy tube that is being used.
The plate 72 is connected to a guiding bar 75 which ends
with an abutment cross-member 76 that can rest at the palm of the
hand of the user.
A slider 80 is slideable on the guiding bar 75, is provided
with grip hollows 81 for the fingers of the operator, and forms
a seat 82 in which it is possible to insert the traction wire 20,
which can be locked by virtue of locking means constituted for
example by a screw 83.
In order to pull the traction wire 20, the operator must
therefore fix the end of the traction wire that protrudes from
the hole formed in the interannular region and then, by resting
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x:he palm .of the hand on the crossmember 7~, puli the traction
wire by acting on the slider 8~, so that ~e can easily extract
t:he penetration element and therefore the tracheostomy tube as
well .
In this manner, the plate 72 furthermore rests against the
outer surface of the trachea, thus providing an abutment element
that prevents lacerations in the region affected by the passage
of the penetration element.
Finally, use of the above described tool allows the operator
to apply traction gradually, accordingly avoiding forces that are
excessive or otherwise dangerous to the patient.
From the above description it is thus evident that the
invention achieves the intended aim and objects, and in
particular the fact is stressed that an apparatus is provided
which allows to produce a tracheostomy according to fully
innovative methods, since the tracheostomy tube is inserted from
the inside of the trachea outward, avoiding an operation which
causes bleeding and in no way damaging the muscle and skin
tissues.
The invention thus conceived is susceptible of numerous
modifications and variations, all of which are within the scope
of the inventive concept.
All the details may furthermore be replaced with other
technically equivalent elements.
In practice, the materials employed, as well as the
contingent shapes and dimensions, may be any according to tt~e
requirements.
