Patent Description:
In particular, the present invention relates to a kit for percutaneous dilational tracheotomy that allows performing an extrusive tracheotomy.

During the hospitalization of patients in intensive care it is often necessary to perform a tracheotomy to manage respiratory failure, to facilitate weaning from mechanical ventilation or to protect the airways.

Tracheotomy is a surgical procedure that allows opening an access to the trachea (stoma) and that can be performed with open surgery or with percutaneous dilational techniques.

Compared to the surgical technique, percutaneous dilational techniques are faster and accessible even to specialists other than the ENT surgeon.

The techniques for performing a percutaneous dilational tracheotomy are divided into two groups, intrusive tracheotomies and extrusive tracheotomies.

In both cases (both for intrusive and extrusive) percutaneous dilational tracheotomies begin with the insertion of a large needle from the outside into the central part of the neck, until the tip is introduced into the lumen of the trachea through its front wall, in a central point and perfectly localized between two of the first tracheal rings. This maneuver is delicate and crucial for the success of the whole operation. For this reason, it is performed under tracheoscopic guidance (that is, directly viewing the trachea from the inside) with a fibrobronchoscope or rigid optics.

After the puncture of the trachea, a guide wire is inserted into the large needle according to the Seldinger technique, which must be pushed in one or the other direction depending on the type of percutaneous dilational tracheotomy to be performed: towards the keel (i.e. towards the distal part of the trachea) if an intrusive tracheotomy is being performed, towards the cranial part of the patient to come out of the mouth if instead an extrusive tracheotomy is being performed.

In intrusive tracheotomies, the tracheal and pretracheal tissues are progressively dilated from the outside towards the inside of the trachea. Conversely, in extrusive tracheotomies the tracheal and pretracheal tissues are progressively dilated from the inside of the trachea towards the outside.

Intrusive tracheotomies are easier and faster to perform and learn, for these reasons they are nowadays the most used.

However, intrusive tracheotomies expose to the risk of rupture of the tracheal rings and the rear wall of the trachea due to the direction of access to the trachea, that is from the outside towards the inside. In addition, intrusive tracheotomies expose to a greater risk of bleeding and infection of the stoma since they require large skin incisions and greater dilation of the tracheal and pretracheal tissues.

On the contrary, extrusive tracheotomies, acting from the inside of the trachea towards the outside, reduce the risk of rupture of the tracheal rings and the rear wall of the trachea; moreover, extrusive tracheotomies require minimal or even no incisions, thereby limiting the risk of bleeding and infection of the stoma.

These advantages of extrusive tracheotomies are indispensable especially in those clinical contexts, increasingly frequent in modern intensive care, with increasingly elderly and complex patients, often treated with anticoagulant and antiplatelet drugs.

A currently known extrusive tracheotomy technique called translaryngeal tracheotomy (TLT) was disclosed in the document: "<NPL>".

The steps for performing this TLT extrusive technique, described below with reference to <FIG> (A-O), include:.

The TLT extrusive tracheotomy technique just described, despite the above-mentioned advantages, is currently out of use due to some technical difficulties in its execution that make it difficult to learn, more insidious and time-consuming to perform compared to the intrusive tracheotomy techniques currently in use.

In detail, the disadvantages of TLT extrusive tracheotomy compared to intrusive tracheotomies are:.

Most of the technical difficulties related to the TLT extrusion technique are due to problems linked to the maneuverability of the above-described components of the TLT extrusion technique kit during the execution of the tracheotomy.

The document <CIT> discloses a method and a kit relating to an endotracheal tube with a tip suitable for traversing the laryngeal inlet and with a guiding channel having a proximal opening adjacent to a proximal end portion and a distal opening adjacent to a tip, wherein the guiding channel is adjacent to a sidewall of the main lumen of the tube.

The main object of the present disclosure is thus to provide a kit of components for extrusive percutaneous dilational tracheotomy which allows performing an extrusive tracheotomy in a simpler way, with maneuvers that are more similar to those commonly used in intrusive tracheotomy techniques, and at the same time in an accurate and safe manner, so as to overcome the aforementioned drawbacks.

Another object of the present disclosure is to provide a kit of components for extrusive percutaneous dilational tracheotomy which includes interchangeable components with kit components already in use in the field of intensive medicine.

A further object of the present disclosure is to provide a kit of components for extrusive percutaneous dilational tracheotomy that it is simple and economical to make.

These objects are achieved through a kit for extrusive percutaneous dilational tracheotomy comprising a dilator tube extended along a longitudinal axis and having a dilation tapered portion ending with a tip and a guide tubular portion, characterized in that said dilation tapered portion and said guide tubular portion are separatable from each other along at least one weakening line transversely extended with respect to said longitudinal axis, the guide tubular portion further comprising, in proximity to said weakening line, hooking means for a mandrel associated with a cannula.

In an embodiment of the kit of components according to the technology, the tapered portion of the dilator tube has a channel therein that is longitudinally extended from the tip and unidirectional locking means for a guide wire in said channel.

In an embodiment of the kit of components according to the technology, the at least one weakening line between the dilation tapered portion and the guide tubular portion of said dilator tube is transversely obliquely extended so as to form, after separation, a guide portion (or guide tube) with a beveled end having a substantially flute-beak-like cross section and having said hooking means in proximity to said beveled end, the kit further comprising a cannula having a beveled end having a profile that is complementary to that of the bevelled end of said guide tubular portion.

In an alternative embodiment, the at least one weakening line between the dilation tapered portion and the guide tubular portion of said dilator tube is perpendicularly extended with respect to the longitudinal axis so as to form, after separation, a guide portion (or guide tube) with a non-beveled end and having said hooking means in proximity to said non-beveled end, and the guide tubular portion further having a longitudinal notch in proximity to said weakening line, said longitudinal notch being substantially opposite said hooking means. In said embodiment, the kit of components may further comprise a conventional cannula with a non-beveled end and i.e. having a substantially right-angled cross section.

In another embodiment, the at least one weakening line is made of a weakening line that is transversely obliquely extended with respect to the longitudinal axis of the dilator tube and of a weakening line that is perpendicularly extended with respect to the longitudinal axis of the dilator tube.

Preferably, the at least one weakening line is at least one incision line.

Advantageously, this allows choosing the most suitable weakening line (or incision line) for the separation of the guide tubular portion based on the cannula that the doctor wishes to use to perform the tracheotomy. In case of use of the transversely oblique incision line to obtain a guide portion with a flute-beak-like beveled portion, the doctor can choose a cannula with a flute-beak-like beveled portion having a complementary profile, cannula which is advantageously included in the kit according to the technology. Vice versa, in case of use of the perpendicular incision line to obtain a guide portion with a non-beveled end, the doctor can choose any cannula with a non-beveled end in common use, which is not necessarily supplied with the kit according to the technology.

Preferably, the cannula has a curved tubular body ending with a flute-beak-like beveled or non-beveled distal end and an opposite proximal end, a flange in proximity to the proximal end and a cuff in proximity to the distal end in fluid communication with a balloon through a small tube. Preferably, the cannula may further have a safety opening known as a "Murphy eye" in proximity to the distal end, which allows the passage of air in the event that the distal end inserted in the trachea closes by leaning against the wall of the trachea itself.

The kit according to the technology may further comprise at least one mandrel to be used in association with a corresponding cannula, the mandrel comprising a rod with a proximal end and a distal end, a maneuvering knob at the proximal end and an anchoring element provided with a cavity at the opposed distal end, the anchoring element being adapted to removably engage with the hooking means of the guide portion of the dilator tube.

Advantageously this allows a quick, easy, and firm anchoring of the cannula to the guide tube. Said cavity of the mandrel is further adapted to disanchor from the hooking means in the tube guide by tilting the cannula after its insertion into the trachea.

Advantageously this allows a quick unhooking of the tube from the cannula from the guide tube, no longer necessary when the cannula is in the trachea.

In an embodiment, the rod of the mandrel is curved and has a fixed length with curvature and length substantially corresponding to those of a curved cannula which it is intended to be associated with.

In another embodiment, the rod of the mandrel is curved or rectilinear with variable length and the mandrel comprises a system for adjusting the length of the rod.

Advantageously, this allows hooking any commercial cannula to the guide tube without having to use the cannula with flute-beak-like ends supplied in the kit.

The kit according to the technology may comprise further components to perform the extrusive dilational percutaneous tracheotomy selected among guide wire, a ventilation small tube, at least one needle and a tracheoscope.

The guide wire has a "J"-shaped soft tip, a cable, and a knob. Said "J"-shaped soft tip is separatable from the braided steel cable while, preferably, said knob is firmly connected to said cable. Said guide wire is easily locked/hooked inside the tip of the dilator tube that has a channel therein with a unidirectional locking system.

Advantageously, this simplifies handling and pulling the guide wire throughout the tracheotomy procedure.

Further features and advantages of the present technology will be evident from the following description of some embodiments given by way of non-limiting example with reference to the attached drawings.

For better understanding and clarity of the figures the elements represented therein may not be on a scale representative of reality. Furthermore, similar elements in the figures will be identified by similar reference numbers.

With reference to <FIG>, a kit of components for performing an extrusive percutaneous dilational tracheotomy according to some embodiments of the present disclosure is now herein described in detail, said kit being globally indicated with reference number <NUM>.

The kit <NUM> comprises a dilator tube <NUM>, a cannula <NUM>, a mandrel <NUM>, a guide wire <NUM>, a ventilation small tube <NUM>, at least one needle <NUM> and a tracheoscope <NUM> according to a possible embodiment of the present disclosure.

<FIG> show an overview and a detailed view of the dilator tube <NUM> of the kit <NUM> for extrusive tracheotomy.

The dilator tube <NUM> has a tapered portion <NUM>, hereinafter referred to as dilation portion <NUM>, and a guide portion <NUM>, hereinafter also referred to as guide tube <NUM>, which are separatable from each other at a weakening line <NUM>, for instance an incision line, to facilitate the separation thereof.

The tapered portion <NUM> has a conical section ending at a first end 211a thereof with a tip <NUM> having an opening 215a, and a cylindrical section connected to the above conical section ending at a second end 211b at the incision line <NUM>. From the opening 215a of the tip <NUM> a channel <NUM> provided with unidirectional locking means <NUM> longitudinally departs inside the conical section of the tapered portion <NUM>.

The opening 215a allows the entry of the guide wire <NUM> into the channel <NUM> of the tapered portion <NUM> of the dilator tube <NUM>. Said guide wire <NUM> may slide inside the channel <NUM> where it encounters the locking means <NUM>, thus remaining firmly anchored to the channel <NUM> of the tapered portion <NUM> of the dilator tube <NUM>. As it will be seen later, the energetic traction of the guide wire <NUM> anchored to the channel <NUM> allows, during the tracheotomy procedure, the creation of the tracheal stoma.

The unidirectional locking means <NUM> are per se conventional and may be for instance ratchet locking, ball locking, arrow locking, arrow and wing locking, pine locking means.

Advantageously, this allows for an easy, quick, and firm anchoring between the guide wire <NUM> and the tapered portion <NUM> of the dilator tube <NUM>, thus overcoming the cumbersome management of the guide wire <NUM> as in the known art, which is critical for the success of the TLT tracheotomy.

The shape of the tapered portion <NUM> of the dilator tube is adapted to facilitate the progression in the tracheal tissues during the dilation step of the tracheotomy, which leads to the formation of the tracheal stoma.

The dilation tapered portion <NUM> is preferably made of biocompatible rigid plastic and may preferably be externally coated with a hydrophilic material commonly used in the dilators of some intrusive tracheotomies, so as to make it more slippery and to favor the progression of the dilator tube <NUM> in the tracheal tissues.

The tip <NUM> of the dilation tapered portion <NUM> is made of metal material, preferably of stainless steel, to favor the dilation of the tracheal tissues.

The channel <NUM> may be made of hard plastic or a metal material.

The guide portion <NUM> of the dilator tube <NUM> has a cylindrical-shaped elongated and flexible body, without preformed curves, open at both ends 212a, 212b and has hooking/unhooking means therein of an assembly made of the mandrel <NUM> and the cannula <NUM> located in the proximity to the end 212a thereof.

In the present embodiment, said hooking/unhooking means include a tooth <NUM> inside the guide portion <NUM> in the proximity to the end 212a thereof.

Moreover, the guide portion <NUM> has at the outer surface thereof and on the entire length a longitudinal demarcation line <NUM> that helps the doctor in the correct orientation of the dilator tube <NUM> for the insertion into the trachea, in particular said line <NUM> identifies the part of the tube that must be held towards the front area of the patient's neck.

The length of the guide portion <NUM> is suitably sized to get out of the patient's mouth during the entire tracheotomy procedure, i.e. it will have a longer length for adult kits and a shorter length for pediatric use kits.

The diameter of the guide portion <NUM> is suitably sized to adapt to the different types of patient, for instance a larger diameter for adult kits and a smaller diameter for pediatric use kits and to allow the insertion of a fibrobronchoscope from the outside of the patient's mouth towards the work area at the tracheal level.

The guide portion <NUM> of the dilator tube <NUM> is preferably made of biocompatible flexible transparent plastic, preferably of PVC, silicone, or similar materials.

The incision line <NUM> placed between the dilation portion <NUM> and the guide tube <NUM> is useful for guiding and facilitating the separation of the dilation portion <NUM> from the guide portion <NUM>, after the creation of the tracheal stoma by means of the dilation portion <NUM>, at the ends 211b, 212a thereof. Further to the separation, the end 212a of the guide portion <NUM> is available to engage with the cannula <NUM> and the mandrel <NUM> associated with each other.

In an embodiment (<FIG>), the incision line <NUM> present on the dilator tube <NUM> is transversely obliquely extended with respect to the longitudinal axis of the dilator tube <NUM> so as to form, after separation of the dilation portion <NUM> from the guide portion <NUM>, a guide portion <NUM> with a beveled end 213a having a substantially flute-beak-like cross section and having the hooking/unhooking means (tooth <NUM>) in the proximity to said beveled end 213a. In particular, in the present embodiment, the hooking/unhooking means are located internally on the longest side of the guide portion <NUM> at the beveled portion 213a.

As it will be better illustrated hereinafter, said guide portion <NUM> is suitable for use with a cannula <NUM> as illustrated in <FIG> associated with a mandrel <NUM> wherein the cannula <NUM> has a beveled end <NUM> having a profile that is complementary to that of the beveled end 213a of the guide portion.

In another embodiment (<FIG>), the incision line <NUM> present on the dilator tube <NUM> is perpendicularly extended with respect to the longitudinal axis of the dilator tube <NUM>, so as to form, after separation of the dilation portion <NUM> from the guide portion <NUM>, a guide portion <NUM> having a non-beveled end 213b (i.e. with right-angle cross section) and bearing the hooking/unhooking means (tooth <NUM>) in the proximity to said right-angle end 213b. In this embodiment, a notch 213c is also preferably provided on the guide portion <NUM> in a position substantially opposite the hooking/unhooking means (tooth <NUM>).

As it will be better illustrated hereinafter, said guide portion <NUM> is suitable for use with any commercial cannula <NUM> commonly used in hospitals and having a non-beveled end 222b associated with a mandrel <NUM>.

In a further embodiment, the dilator tube <NUM> may have both an incision line <NUM> obliquely extended, and an incision line <NUM> extended perpendicularly, as visible in <FIG>.

Advantageously, this allows the doctor to choose, by cutting the dilator tube <NUM> along the appropriate incision line, the preferred or most suitable cannula for tracheotomy without any constraint on the use of cannula <NUM> contained in the kit <NUM>.

In this way, the kit of components <NUM> according to the technology may also be advantageously integrated with kits/ commercial components used in intensive medicine.

<FIG> shows an overall view of the cannula <NUM> and mandrel <NUM> of the kit <NUM> for extrusive tracheotomy according to an embodiment of the present disclosure.

The cannula <NUM> comprises a curved tubular body <NUM>, a first end or distal end <NUM>, a second end or proximal end <NUM>, a flange <NUM> in proximity to the second end <NUM> and a small tube <NUM>.

The first end <NUM> of the cannula <NUM> has a beveled cross section, substantially in the shape of a flute beak complementary to the beveled end 213a of the guide portion <NUM> after the separation thereof from the dilation portion <NUM> along the incision line 213a.

The first end <NUM> of the cannula <NUM> is adapted to be juxtaposed to the beveled end 213a of the guide portion <NUM> by coupling between complementary profiles and removably engaged, thought the mandrel <NUM>, to the guide tube <NUM>, so that the cannula <NUM> and the guide tube <NUM> are adjacent in use.

The first end <NUM> of the cannula <NUM> may preferably have a further safety opening (not shown) known as a "Murphy eye", which allows the passage of air in the event that the end <NUM> inserted in the trachea closes by leaning against the wall of the trachea itself after the separation of the cannula <NUM> from the guide tube <NUM>.

The second end <NUM> of the cannula <NUM> is provided with a universal fitting for the mechanical ventilation since it is intended to remain external to the trachea to engage with automatic or manual ventilation tools.

The curved tubular body <NUM> has at the first end <NUM> a cuff <NUM> in fluid communication with the small tube <NUM>. The small tube <NUM> runs in the thickness of the wall of the curved tubular body <NUM> of the cannula <NUM> ending with a balloon <NUM>.

The cuff <NUM> is therefore inflatable through the balloon <NUM> and, once inflated, it generates a tight coupling with the trachea, thus allowing the use of positive pressure ventilation.

The flange <NUM> is usually an oval-shaped soft foil and has two opposite holes 224a and 224b. The flange <NUM> is movable and perpendicular with respect to the tubular body <NUM> of the cannula <NUM> and is adjustable to be adapted to any type of patient. The flange <NUM> is the limit beyond which the cannula <NUM> cannot be inserted into the trachea. The holes 224a and 224b allow, through the use of conventional fastening straps (not shown), to fix the cannula <NUM> and keep it in the correct position during the movements of the head and swallowing.

During use, the fluid connection between the small tube <NUM> and the cuff <NUM> allows inflating, through the pilot balloon <NUM>, the cuff <NUM> of the cannula <NUM>, thus creating a tight coupling between the cuff <NUM> and the trachea.

The cannula <NUM> is preferably made of biocompatible plastic material, such as for instance PVC, silicone, etc..

The mandrel <NUM> has a curved rod <NUM> ending at an end with a maneuvering knob <NUM> and, at the opposite end, with an anchoring element <NUM>.

The rod <NUM> of the mandrel <NUM> has a curvature similar to that of the body <NUM> of the cannula <NUM>, so as to be easily inserted thereinto and a similar length, so as to protrude the anchoring element <NUM> from the first end <NUM> of the cannula <NUM>.

The knob <NUM> is useful to maneuver the mandrel <NUM> when it is placed inside the cannula <NUM>.

The anchoring element <NUM> of the mandrel <NUM> is in the shape of a cylindrical body, rounded at its free end (or tip) <NUM>, having a cavity <NUM> adapted to engage in a removable manner, when in use in association with the cannula <NUM>, with the tooth <NUM> of the guide tube <NUM> of the dilator tube <NUM>, thus anchoring the cannula <NUM> to the guide tube <NUM>. The anchoring system tooth <NUM>/cavity <NUM> is made so as to ensure an optimal seal of the cannula <NUM>/guide tube <NUM> assembly until they are aligned with each other and to facilitate the unhooking of the cannula <NUM> from the guide tube <NUM> when the cannula <NUM>/mandrel <NUM> assembly bends with respect to the axis of the tube guide <NUM>.

Advantageously, this hooking/unhooking system allows overcoming the prior art problems relating to the cone-cannula <NUM> management.

Advantageously, the rounded tip <NUM> prevents injury to the tracheal lumen and therefore makes it safe to maneuver the mandrel during its insertion into the trachea.

<FIG> shows in detail the hooking/unhooking system of the cannula <NUM>/mandrel <NUM> assembly with the guide tube <NUM> of the kit <NUM> for extrusive tracheotomy according to alternative variants of the present technology.

In the first variant shown on the left in <FIG>, the guide tube <NUM> separated from the dilation portion <NUM> has a flute-beak-like beveled end 213a with the hooking means (tooth <NUM>) arranged therein on the longer side at said beveled end 213a and the cannula <NUM> has a flute-beak-like beveled end 222a having a complementary profile to that of the beveled end 213a of the guide tube <NUM>.

To perform the hooking, the cannula <NUM> is arranged substantially in axis with the guide tube <NUM> with its beveled end 222a juxtaposed to the beveled end 213a of complementary profile of the guide tube <NUM>, so as to allow the engagement of the tooth <NUM> into the cavity <NUM> of the anchoring element <NUM>.

To perform the unhooking, the cannula <NUM> may be tilted with respect to the guide tube <NUM>, keeping away its beveled portion 222a from the beveled portion 213a of the guide tube, so as to cause the unhooking of the anchoring element <NUM> from the tooth <NUM>.

In the second variant shown on the right in <FIG>, the guide tube <NUM> separated from the dilation portion <NUM> has a non-beveled end 213b (i.e. a right angle) in proximity to which the hooking means (tooth <NUM>) and the notch 213c are therein arranged opposite each other and the cannula <NUM> also has a non-beveled end 222b.

To perform the hooking, the cannula <NUM> is arranged substantially in axis with the guide tube <NUM> with its non-beveled end 222b juxtaposed to the non-beveled end 213b of the guide tube <NUM>, so as to allow the engagement of the tooth <NUM> into the cavity <NUM> of the anchoring element <NUM>.

To perform the unhooking, the cannula <NUM> may be tilted with respect to the guide tube <NUM>, so as to cause the unhooking of the anchoring element <NUM> from the tooth <NUM>, unhooking which is facilitated by the presence of the opposite notch 213c.

<FIG> shows several variants of the mandrel <NUM> of the kit <NUM> for extrusive tracheotomy subject-matter of the present disclosure.

In detail, the mandrel 23a is the mandrel preferably present in the kit <NUM> and has been already previously described with reference to <FIG>. The mandrel 23a is fixed and has an ideal shape and length to enter the cannula <NUM> with flute-beck ends 222a of the kit <NUM> and to release the anchoring element <NUM> provided with cavity <NUM> for the removable engagement with the tooth <NUM> of the guide tube <NUM>.

Instead, the mandrel 23b is a universal mandrel adapted to adapt with <NUM> different cannulas if their shape does not allow the use of the mandrel 23a. The mandrel 23b differs from the above-described mandrel 23a substantially in that the rod <NUM> has a variable length and is therefore provided with a length-adjustment system <NUM> located at the knob <NUM>.

The adjustment system <NUM> is preferably of the screw type and allows the mandrel 23b to adapt to different lengths of the cannulas <NUM> by pushing the cannula <NUM> to perfectly couple with the guide tube <NUM>, by adjusting the screw of the adjustment system <NUM> when the mandrel 23b is inserted into the cannula <NUM> and hooked to the guide tube <NUM> with right-angled ends 213b.

Advantageously, this allows obtaining a correct coupling between any commercial cannula and the guide tube <NUM>, provided that their outer diameter is substantially the same or similar so as to be compatible.

Advantageously, this allows supplying the kit <NUM> even without the flute-beak-like cannula <NUM> but only with the components necessary to perform the extrusive tracheotomy according to the method described in the present disclosure, i.e. the dilator tube <NUM> and possibly the universal mandrels 23b, 23c and the guide wire <NUM>, using commercial components already in use in the field of intensive medicine for the rest.

Furthermore, the mandrel 23c is a straight universal mandrel, whose rod <NUM> has no curvature. For this reason, the mandrel 23c is used in cannulas <NUM> having a particularly soft tubular body <NUM>, which are thus made rectilinear during the insertion step into the trachea.

The cavity <NUM> of the anchoring element <NUM> of the mandrel 23c, conversely to the cavities <NUM> of the mandrels 23a and 23b, allows a hooking and unhooking of the mandrel 23c from the guide tube <NUM> through a rotation of the mandrel 23c on its main axis by mean of the knob <NUM>.

The knob <NUM> of the mandrel 23c has an adjustment system <NUM>, preferably a screw-type one, to adapt to different lengths of the cannulas <NUM>.

The mandrels 23a, 23b and 23c are preferably made of a malleable plastic material, for instance PVC, so that their rod <NUM> is adaptable to the shape and angle of the different cannulas and to the patient's airways.

The mandrels 23a, 23b and 23c may preferably be inserted into the kit at the same time <NUM>.

Advantageously, this allows the doctor to choose the cannula <NUM> with the most suitable features for the tracheotomy and to always have a type of mandrel 23a, 23b or 23c available to couple it correctly to the guide tube <NUM>.

Advantageously, this allows the kit <NUM> to integrate with commercial components commonly used in intensive medicine.

<FIG> shows the mandrel 23c of <FIG> inserted in the cannula <NUM> during the hooking step to the guide tube <NUM> and the unhooking step from the guide tube <NUM>.

The mandrel 23c is inserted in the soft cannula <NUM> and made straight by the mandrel 23c itself.

The screw adjustment system <NUM> adjusts the length of the mandrel 23c to ensure that the cavity <NUM> of the mandrel 23c hooks to the tooth <NUM> of the guide tube <NUM>, thus ensuring the perfect coupling of the cannula <NUM> and of the guide tube <NUM>.

In this way, the cannula <NUM> in use adjacent to the guide tube <NUM> may be seamlessly inserted into the tracheal stoma (not shown) by pulling the guide tube <NUM>, already inserted in the trachea, towards the patient's mouth.

When the cannula <NUM> is inserted in the tracheal stoma (not shown), it is possible to unhook the mandrel 23c from the guide tube <NUM>.

The unhooking of the mandrel 23c from the guide tube <NUM> takes place by rotating the mandrel 23c on its axis through the rotation of the end <NUM> of the mandrel 23c operated by the doctor.

As for <FIG>, the other components of the extrusive tracheotomy kit <NUM> present in an embodiment of the present disclosure will now be described.

The guide wire <NUM> has a "J" soft tip <NUM>, a cable <NUM> and a knob <NUM>.

The cable <NUM> is made of braided steel and has two ends.

One end of the cable <NUM> is joined to the "J" tip <NUM>, whereas the other end of the cable <NUM> is joined to the knob <NUM>.

The knob <NUM> is made of plastic material, is cylindrical in shape and suitable for being easily gripped.

The knob <NUM> is needed to roll up the cable <NUM> while exerting a controlled traction on the cable <NUM> during the execution of the tracheotomy.

Advantageously, the cable <NUM> of the guide wire <NUM> is preferably already firmly connected to the knob <NUM> thus eliminating the technical difficulties present in the prior art.

The ventilation small tube <NUM> is per se conventional and has an elongated and thin tubular shaped body <NUM> and two ends <NUM> and <NUM> and a small tube <NUM>.

The end <NUM> of the ventilation small tube <NUM> is at right angle and has, likewise to the end <NUM> of the cannula <NUM>, an inflatable cuff <NUM> for the positive pressure ventilation and airway protection.

The end <NUM> of the ventilation small tube <NUM> is provided, likewise to the end <NUM> of the cannula <NUM>, with a universal fitting for the mechanical ventilation.

The small tube <NUM>, likewise to the small tube <NUM> of the cannula <NUM>, allows inflating, through the pilot balloon <NUM>, the cuff <NUM> of the ventilation small tube <NUM>, creating a tight coupling between the cuff <NUM> and the trachea.

It may be appropriate for the ventilation small tube <NUM> to be long enough to allow cuff <NUM> to be positioned just above the keel of the trachea, distally with respect to the area where the stoma will be created.

The ventilation small tube <NUM> preferably has a diameter suitable to allow the simultaneous entry into the trachea of the dilator tube <NUM> during the execution of the tracheotomy. For instance, in the case of an adult male, in which the cannula <NUM> could have an internal diameter of <NUM>, the ventilation small tube <NUM> could have an internal diameter of <NUM>.

The needle <NUM> must be of adequate caliber to allow the guide wire <NUM> to enter. Preferably, the needle <NUM> could be a curved sharp needle 26a or of the "Tuohy" type 26b.

The tracheoscope <NUM> has an elongated and thin tubular body <NUM> and two ends <NUM> and <NUM> and a small tube <NUM>.

The end <NUM> of the tracheoscope <NUM> is flute-beak-like and has, likewise to what has already been described regarding the cannula <NUM> and the ventilation small tube <NUM>, an inflatable cuff <NUM> for positive pressure ventilation and airway protection.

The end <NUM> of the tracheoscope <NUM> is provided, likewise to what has already been described regarding the cannula <NUM> and the ventilation small tube <NUM>, with a universal fitting for the mechanical ventilation.

The small tube <NUM>, likewise to what has already been described regarding the cannula <NUM> and the ventilation small tube <NUM>, allows inflating, through the pilot balloon <NUM>, the cuff <NUM> of the tracheoscope <NUM>, thus creating a tight coupling between the cuff <NUM> and the trachea.

The tracheoscope <NUM> allows access to rigid optics and stabilization of the trachea during the tracheal puncture.

With reference to <FIG> and <FIG>, a new method for performing extrusive percutaneous dilational tracheotomy with the kit <NUM> according to the technology will now be described.

In light of the above, the kit of components according to the technology achieves the pre-fixed aims and numerous advantages with respect to the prior art.

Indeed, the kit <NUM> for extrusive tracheotomy according to the technology advantageously allows performing an extrusive percutaneous dilational tracheotomy in a simpler and safer manner than the prior art techniques and with maneuvers similar to those of the intrusive tracheotomy techniques currently most used in the field of intensive medicine.

Advantageously, this makes the extrusive percutaneous dilational tracheotomy technique faster and easier to learn and perform.

In particular, the advantages of this extrusive tracheotomy technique with respect to the TLT extrusive tracheotomy technique are:.

In light of what has been described above, the kit <NUM> for extrusive percutaneous dilational tracheotomy of the present technology allows performing an extrusive tracheotomy, thus reducing the drawbacks of the prior art.

Yet, the kit <NUM> for extrusive percutaneous dilational tracheotomy of the present disclosure may contain components that are universal and usable with the commercial ones normally used in the field of intensive medicine.

Finally, the kit <NUM> for extrusive percutaneous dilational tracheotomy of the present disclosure is easy and simple to make.

Claim 1:
Kit (<NUM>) of components for extrusive percutaneous dilational tracheotomy comprising a dilator tube (<NUM>) that is extended along a longitudinal axis and having a dilation tapered portion (<NUM>) ending with a tip (<NUM>) and a guide tubular portion (<NUM>), characterized in that said dilation tapered portion (<NUM>) and said guide tubular portion (<NUM>) are separatable from each other along at least one weakening line (211b; 212a), preferably an incision line, which is transversely extended with respect to said longitudinal axis, the guide tubular portion (<NUM>) further comprising, in proximity to said weakening line (211b; 212a), hooking means (<NUM>) for a mandrel (23a; 23b; 23c) associated with a cannula (<NUM>).