Tracheotomy device

Abstract

The present invention relates to a device (1) for creating a tracheal hole (F) for a tracheotomy procedure in a simple, safe and reliable way.

Description

[0001] TRACHEOTOMY DEVICE

[0002] The present invention relates to a device for tracheotomy or tracheostomy.

[0003] In particular, the present invention relates to a medical device for performing a tracheotomy procedure, in particular a tracheo-prick procedure, and the positioning of the tracheostomy cannula.

[0004] As is well known, tracheotomy is a surgical procedure that consists in opening the trachea to create direct access to the airways.

[0005] In medical practice, today there exist various techniques for carrying out a tracheotomy procedure. A classic tracheotomy procedure provides for the following steps:

[0006] - prior to the intervention, the patient undergoes local or general anaesthesia depending on the severity of his or her condition and the expected duration of the intervention,

[0007] - the patient is positioned so as to have his or her neck extended to facilitate access to the trachea,

[0008] - with a scalpel, the surgeon makes a "U" or "V" shaped incision in the skin of the neck to expose the neck muscles,

[0009] - after having exposed the neck muscles, the surgeon uses a forceps to delicately separate the tissues and reveal the trachea,

[0010] - the surgeon makes an incision in the trachea to create an opening through which the patient can breathe,

[0011] - once the opening is created in the trachea, the surgeon inserts a tracheal pipe through it; said pipe is then attached to the skin of the neck to prevent it from moving, and

[0012] - the surgeon closes the incision in the skin of the neck with stitches or surgical staples.

[0013] However, said procedure poses some risks and complications, including haemorrhages, infections, nerve lesions and wound healing problems.

[0014] An alternative to the procedure with a scalpel is given by the Seidinger procedure, which today is the most widely used procedure. This procedure provides for the use of a needle by the surgeon to perforate the trachea through the skin and soft tissues of the neck. Subsequently, a guiding thread is inserted into the trachea through the needle. The needle is then removed, leaving the guiding thread inside the trachea. The surgeon then inserts a catheter into the trachea, following the path of the guiding thread. In order to expand the opening in the trachea, use can be made of various dilatative devices which are inserted and then removed by means of the guiding thread, or the catheter itself can be used. Finally, a cannula, i.e. a plastic pipe, is inserted into the opening to create a stable airway.

[0015] The tracheotomy procedure with the Seidinger system is considered less invasive than the classic tracheotomy technique because the guiding thread and the catheter can be inserted through a smaller opening than is necessary for a traditional tracheotomy. However, this procedure as well poses risks such as, for example, of perforating the trachea and damaging the surrounding tissues.

[0016] A tracheotomy with the Seidinger system can also be performed with a fiberscopic guide. In this case, a flexible fiberscope is used to guide the needle and the catheter into the trachea through the incision in the skin. In particular, the fiberscope is inserted into the trachea through the patient’s mouth or nose to visualise the inside of the trachea and guide the needle through the skin and soft tissues of the neck down to the trachea. Subsequently, a catheter is inserted through the needle in the trachea, following the path of the fiberscope. Tracheotomy with a fiberscope is a less invasive tracheotomy technique than traditional tracheotomy because it does not require a surgical incision in the neck. Moreover, a fiberscope enables the surgeon to visualise the inside of the trachea in real time, making it easier to guide the needle and the catheter into the correct position. However, this procedure as well entails a series of risks.

[0017] In conclusion, to date all the percutaneous procedures and the related devices on the market for tracheotomy procedures have not eliminated the following problems of this delicate operation:

[0018] - risk of puncturing the rear wall of the trachea,

[0019] - risk of puncturing the fiberscope (often subject to damage as a result of punctures by the guide needle),

[0020] - risk of lesions and bleeding during the dilation step, with associated inhalation of blood and all the connected ventilatory or oxygenation complications,

[0021] - risk of breakage of the cartilaginous rings during the dilation step,

[0022] - risk of lesions to the inner walls of the trachea during the introduction of dilatators,

[0023] - risk of creating false entryways during the introduction of the tracheostomy cannula,

[0024] - impossibility of performing the Seidinger procedure on paediatric patients and on neonates, due to the excessive elasticity of the tracheal structure, which precludes the use of dilators.

[0025] All these possible complications are rendered more serious and sometimes fatal due to the fact that the area concerned is small in size and is the sole point for the passage of air to the lungs.

[0026] Furthermore, in view of the complexity of the procedure and the associated risks, at least three dedicated operators are necessary to perform tracheotomies with the above-described methods.

[0027] Thus, in the specific sector there exists a need for novel devices for performing a tracheotomy procedure which are capable of overcoming the disadvantages of the known devices.

[0028] This need is satisfied by the device according to the present invention, which offers, moreover, further advantages that will become clear hereinbelow.

[0029] The aim of the present invention is thus to provide a tracheotomy device that makes it possible to overcome the limits of the devices used in the techniques according to the prior art and to obtain the previously described technical results.

[0030] Furthermore, it is an aim of the present invention to provide a tracheotomy device adapted to perform the procedure also on paediatric patients and on neonates.

[0031] A further aim of the invention is that said device can be made at substantially low costs, both as regards the production costs and as far as the management costs are concerned.

[0032] Yet another aim of the invention is to propose a tracheotomy device that is simple, safe and reliable.

[0033] Therefore, a specific aim of the present invention is a tracheotomy device or system or a tracheotomy kit for creating a tracheal hole for the tracheotomy procedure, said device or system or kit being characterised in that it comprises:

[0034] - a sliding device adapted to be introduced through a ventilation pipe used for ventilation of the patient, said sliding device comprising

[0035] - a guiding thread, preferably a metal cable, adapted to enter from said ventilation pipe and to exit from the tracheal hole,

[0036] - a dilatative cannula with a substantially tubular shape, adapted to be introduced through said ventilation pipe, comprising a front end attached to said guiding thread and a back end, said front end of the dilatative cannula having a diameter that is smaller than the diameter of said back end of the dilatative cannula, said dilatative cannula comprising at least one metal portion made of a metallic material adapted to be attracted by a magnet or at least one magnetic portion at said front end, said sliding device alternatively comprising

[0037] - a needle coupled to said front end (431 ) of said dilatative cannula or

[0038] - a housing adapted to be hook onto a needle, said housing being positioned in proximity to the front end of said dilatative cannula, wherein said at least one metal or magnetic portion of said dilatative cannula, once introduced into the trachea, is adapted to be attracted by a magnet placed outside the trachea, so as to allow the coupling of said needle with said magnet or of said housing with a needle coupled to said magnet, thereby creating said tracheal hole and generating a relative dilation of said tracheal hole through the passage of said dilatative cannula from the inside towards the outside.

[0039] According to the invention, said guiding thread can comprise a back end, a front end and at least one metal portion, at said front end, made of a metallic material adapted to be attracted by a magnet, said dilatative cannula being attached to said front end of said guiding thread. In this embodiment, said needle can be optionally coupled both to said front end of said dilatative cannula and to said front end of said guiding thread, or said housing can be coupled both to the front end of said dilatative cannula and to the front end of said guiding thread.

[0040] In particular, according to the invention said device can further comprise: a coupling device comprising an end portion adapted to be coupled to a hole of a flange for tracheostomy, said coupling device comprising a magnet optionally positioned in proximity to said end portion, wherein

[0041] - said needle is coupled alternatively to one of said front end of said dilatative cannula and said end portion of said coupling device, and wherein

[0042] - said housing adapted to be hook onto said needle is positioned in proximity to the end portion of said coupling device when said needle is coupled to the front end of said dilatative cannula, or is positioned in proximity to the front end of said dilatative cannula when said needle is coupled to the end portion of said coupling device.

[0043] Therefore, according to a first embodiment of the present invention, said needle is coupled to the front end of the dilatative cannula and, together with the metal portion of the dilatative cannula, will be attracted by the magnet present in said coupling device, positioned outside the trachea, which comprises the needle housing in proximity to the end portion thereof. In this embodiment, the needle housing can be positioned, for example, inside the magnet itself. In this manner, the tracheal hole will be made from the inside towards the outside, since from the inside of the trachea the needle will be coupled to the housing thereof present outside, inside said coupling device, passing beyond the patient’s trachea and skin.

[0044] According to one embodiment, said needle and said housing have a coupling of a screw-thread type.

[0045] According to a second embodiment, said needle is coupled to the end portion of said coupling device adapted to be coupled to said flange. In this embodiment, the needle can be, for example, housed in the magnet. In this manner, the magnet will attract the metal portion of the dilatative cannula, whose front end comprises the needle housing. In this embodiment, the needle housing can be, for example, a microcapsule. In this manner, the tracheal hole will be made from the outside towards the inside, since from outside the patient’s throat the needle will be coupled to the housing thereof present inside, at said dilatative cannula, passing beyond the patient’s trachea and skin.

[0046] According to the invention, said coupling device can comprise a grip area adapted to allow it to be gripped by the operator, and said grip area can comprise a handle element adapted to be gripped more firmly in order to allow a larger pulling force to be exerted, and preferably placed at the end opposite said end portion.

[0047] Furthermore, said coupling device can internally comprise a winding system, for example a roller or reel able to wind the sliding device inside it as the latter is extracted from the hole. This allows the operator to be safeguarded, without making him or her come into direct contact with organic liquids.

[0048] Preferably, said dilatative cannula is made of a flexible material such as silicone or plastic.

[0049] Furthermore, said housing preferably comprises a fitting system, for example a snap-fit system, adapted to fix the tip of the needle in the housing thereof. According to the invention, said magnet can be activated by movement devices, activated for example by a pushbutton or a trigger. Furthermore, said movement devices can comprise a means for moving the magnet nearer to or further from the hole of said flange, in order to gradually attract the metal portion of the sliding device.

[0050] Moreover, according to the invention, said sliding device can comprise a guide with a substantially tubular shape for positioning a tracheostomy cannula, positioned downstream of the back end of said dilatative cannula, said guide comprising a front end and a back end, said front end being attached to said guiding thread, wherein said guide is adapted to be introduced into the ventilation pipe at said back end of said guide.

[0051] Said guide is adapted to facilitate the introduction of the tracheostomy cannula. Said guide, like the whole sliding device, is adapted to be introduced into the patient’s ventilation pipe V.

[0052] In particular, said guide can comprise holes on the walls adapted to ensure a regular passage of air to the lungs and / or a unidirectional membrane, for example a bicuspid valve, adapted to allow the passage of air inside it only towards the mouth and prevent the passage of airflows towards the lungs, even if subjected to a strong and sudden air pressure, as in the case of coughing, in order to prevent the device from rising towards the mouth. Furthermore, said sliding device can comprise a safety element coupled to said guiding thread at said front end of said guide. In particular, said safety element enables the operator to quickly remove the sliding device from the ventilation pipe in the event of problems during the procedure.

[0053] In particular, according to the invention said dilatative cannula and / or said guide can have a hollow cylindrical shape.

[0054] Furthermore, according to the invention said guiding thread can switch through said dilatative cannula and / or said guide.

[0055] In particular, according to the invention said magnet can alternatively comprise said housing and said needle.

[0056] According to one embodiment, said dilatative cannula can have a truncated cone shape with an increasing diameter.

[0057] Again according to the invention, said dilatative cannula can be a telescopic dilatative cannula comprising a series of cylindrical sections with an increasing diameter, said cylindrical sections being adapted to switch from a closed configuration, in which they are positioned one inside the other, to an open configuration, in which they are positioned, partially overlapping, one after the other. In particular, in this embodiment, said front end of the dilatative cannula is positioned in the cylindrical section having the smallest diameter and said back end of the dilatative cannula is positioned in the cylindrical section having the largest diameter. Said telescopic dilatative cannula is in the closed configuration during the passage of the dilatative cannula in the ventilation pipe until the coupling of the needle with the respective housing in the point of perforation and passes into the open configuration during the extraction of said dilatative cannula from the hole.

[0058] Furthermore, said dilatative cannula can further comprise a plurality of notches in proximity to the front end thereof, i.e. in the point in which it must be bent in order to direct the end thereof towards the patient’s trachea. When said dilatative cannula is a telescopic dilatative cannula, said notches are preferably present on all the cylindrical sections with the exception of the one with the smallest diameter.

[0059] In particular, according to the invention said sliding device can comprise dilatative means coupled to said dilatative cannula, said dilatative means being adapted to further dilate the tracheal hole.

[0060] Furthermore, according to the invention said dilatative means can comprise an atraumatic expandible ring adapted to allow a uniform dilation and fixed on said back end of said dilatative cannula.

[0061] In particular, according to the invention said dilatative means can comprise a second dilatative cannula comprising a front end and a back end, said front end having a diameter equal to the diameter of said front end of said dilatative cannula and preferably having a smaller diameter than said back end of said second dilatative cannula, said front end of said second dilatative cannula being adapted to enter into said dilatative cannula at the back end of said dilatative cannula, said dilatative cannula comprising, in proximity to the back end, a longitudinal notch adapted to favour the entry of said second dilatative cannula, said second dilatative cannula comprising a traction wire attached to the front end of said second cannula and adapted to slide inside said dilatative cannula in order to exit from the tracheal hole. In fact, by means of a pulling force exerted from outside the tracheal hole, with said traction wire, for example made of steel, said second dilatative cannula is adapted to further dilate the first dilatative cannula, thereby considerably increasing its diameter, until arriving at a preset maximum width. Therefore, in said embodiment said sliding device comprises said guiding thread adapted to slide inside said dilatative cannula and said second cannula and said traction wire attached to the front end of the second cannula and adapted to slide inside the dilatative cannula.

[0062] Moreover, according to the invention said dilatative means can comprise a second dilatative cannula comprising a front end and a back end, said front end having a smaller diameter than said back end of said second dilatative cannula, said second dilatative cannula being attached to said guiding thread in proximity to the front end thereof so that the front end of said dilatative cannula and the front end of said second dilatative cannula are substantially adjacent to each other and both attached to said guiding thread and so that when said front end of said dilatative cannula is attracted by said magnet, it allows a coupling between the needle and housing and the creation of the tracheal hole, while generating a further dilation given by the passage of said dilatative cannula and of said second cannula adjacent to each other. In other words, the two front ends of said dilatative cannula and said second dilatative cannula, under the pulling force of the guiding thread passing through them, are joined in proximity to the tips, comprising a metal and / or magnetic part, and are bent into an arc, pushing the hole from where the needle comes out towards the point to be perforated.

[0063] In particular, said second cannula can be inserted into said tracheal pipe before or after the insertion of said dilatative cannula and can thus be positioned upstream or downstream of said dilatative cannula. In any case, in this embodiment, the front ends of each of the two cannulas are substantially adjacent to each other so that when said front end of said dilatative cannula is attracted by said magnet a coupling takes place between the needle and housing and the tracheal hole is created, generating a further dilation given by the passage of said dilatative cannula and said second cannula adjacent to each other through the tracheal hole.

[0064] In a further embodiment, the front end of said second cannula can also comprise a metal portion.

[0065] In particular, according to the invention said device can further comprise a flange comprising a hole and adapted to be positioned around the patient’s neck.

[0066] Moreover, according to the invention, said device can comprise a support means adapted to prevent pressure from being applied on the trachea at the moment when said coupling device is attached to said flange positioned on the trachea. In particular, said support means can comprise or consist of support legs attached to said flange or to said coupling device. Said legs are preferably adjustable so as to be able to exert pressure, during the procedure, without crushing the patient’s trachea.

[0067] Furthermore, according to the invention said device can comprise a coupling means for coupling said coupling device with a flange. In particular, said coupling means can comprise anchorage grippers fixed on the end portion of said coupling device and / or anchorage grippers to be engaged to said coupling device and / or a rigid structure adapted to allow the housing of said coupling device on said flange.

[0068] The effectiveness of the device of the present invention is evident, as it enables the tracheotomy procedure to be performed while reducing the risks of the procedures presently used. In particular, the device according to the present invention enables the tracheotomy procedure to be performed while constantly protecting the inner walls of the trachea.

[0069] Furthermore, the effectiveness of the device according to the present invention is evident, as it enables the tracheotomy procedure to be performed also on paediatric patients and on neonates.

[0070] The present invention will now be described, by way of non-limiting illustration according to a preferred embodiment thereof, with particular reference to the figures of the appended drawings, wherein:

[0071] - figure 1a shows the sliding device according to the present invention inserted in the ventilation pipe,

[0072] - figure 1b shows the sliding device in figure 1 a and the coupling device according to the present invention,

[0073] - figure 2 shows a perspective view of a flange comprising a housing for said coupling device,

[0074] - figure 3 shows a perspective view of a support means attached to said flange,

[0075] - figure 4 shows a perspective view of a first embodiment of a dilatative cannula according to the present invention,

[0076] - figure 5 shows a perspective view of a second and a third embodiment of said dilatative cannula according to the present invention,

[0077] - figure 6 shows a first embodiment of the dilatative means according to the present invention, - figure 7 shows a second embodiment of the dilatative means according to the present invention,

[0078] - figure 8 shows a third and a fourth embodiment of the dilatative means according to the present invention,

[0079] - figure 9 shows the sliding device according to the present invention, comprising a guide and a dilatative cannula, before (Fig. 9a) and after (Fig. 9b) the introduction of the guide into the trachea.

[0080] The description below will be focused on a tracheotomy device according to the present invention.

[0081] Making reference to the figures, the reference number 1 will be assigned to a tracheotomy device according to the present invention. In particular, making reference to figures 1a, 1 b and 4, said device 1 comprises a sliding device 4 adapted to be introduced through a pipe V used for ventilation of the patient (ventilation pipe V or orotracheal pipe V). Said sliding device 4 comprises a guiding thread 42 comprising an end A, also called back end of the guiding thread, and an end B, also called front end of the guiding thread. Said guiding thread 42 can be a metal cable, such as for example made of steel or nylon or another material with good tensile strength and can be made of conductive material. Furthermore, said guiding thread 42 is capable of entering from said ventilation pipe V and exiting from the tracheal hole F. For safety reasons, said at least one guiding thread 42 can consist in two or more guiding threads.

[0082] Again making reference to figures 1 a, 1 b and 4, said sliding device 4 comprises a dilatative cannula 43 at the end B of the guiding thread 42. Said dilatative cannula 43 is a cannula that is hollow inside, preferably made of a flexible, crush-resistant material such as silicone or plastic, and is passed through by said guiding thread 42 so that the front end B of the guiding thread 42 terminates in proximity to a front end 431 of said dilatative cannula 43 and is attached to said front end 431 , whilst the back end A of the guiding thread comes out of a back end 432 of the dilatative cannula 43. Preferably, said guiding thread 42, along the portion that passes through said dilatative cannula 43, is attached to the inner wall of said dilatative cannula 43 or is an integral part of the wall of said dilatative cannula 43. Furthermore, at least one portion of the front end 431 of said dilatative cannula 43 turned towards the front end B of the guiding thread 42, i.e. the end portion of the dilatative cannula which, when in use, will be adapted to adhere to the wall of the trachea, comprises metallic and / or magnetic material so that the end portion can be attracted by a magnet placed outside the trachea in the point in which the hole F will be made.

[0083] In the embodiment shown in figures 1 ,4 and 5, the dilatative cannula 43 is in fact adapted to be introduced, starting from the front end 431 , together with the guiding thread 42 passing inside it, into the patient’s ventilation pipe V until arriving in the trachea, i.e. a couple of centimetres beyond the end of the ventilation pipe, in proximity to the point in which the hole F will be made. The front end B of the guiding thread and / or the front end 431 of said dilatative cannula 43, attached to each other, are adapted to be attracted by the magnet. The positioning of said sliding device 4 and, in particular, of said dilatative cannula 43 can be favoured by possible lights visible through the skin and / or through the use of an internal video camera.

[0084] In particular, in the embodiment shown in figures 4 and 5, said sliding device 4 comprises a needle 5 coupled to said front end 431 of said dilatative cannula 43.

[0085] In an alternative embodiment, not shown, said sliding device 4 comprises a housing adapted to engage to an external needle, said housing being coupled to said front end 431 of said dilatative cannula 43.

[0086] In particular, said at least one metal portion of said dilatative cannula 43 and / or of said guiding thread 42, once introduced into the trachea, is adapted to be attracted by said magnet placed outside the trachea, so as to allow the coupling of said needle 5 with said magnet or of said housing with a needle coupled to said magnet, thus creating said tracheal hole F and generating a relative dilation of said tracheal hole F through the passage of said dilatative cannula 43 from the inside towards the outside.

[0087] Making reference to the embodiment shown in figures 2-3, said device 1 can comprise a flange 2, adapted to be positioned around the patient’s neck, closely adherent to the trachea, so as to isolate the point of interest for the operation, that is, the area to be pricked to create the tracheal hole F. Said flange 2 comprises a central hole 20 that will surround the hole that will be made in the patient’s neck for the tracheotomy procedure, i.e. the tracheal hole F. Said flange is in fact necessary for isolating the point of intervention and acts as an area of support and traction for making a precise guided prick. Said flange 2 preferably comprises two halves which can be joined together by means of a suitable fitting and locking system in order then to be separated from each other for the removal of the flange. In particular, the removal of the flange can take place before the insertion of a tracheostomy cannula.

[0088] Making reference to the embodiments shows in figures 1 b-2, said device 1 further comprises a coupling device 3 adapted to be coupled to said flange in proximity to said hole 20. Said coupling device 3 can comprise levers, controls and visual / audible signalling elements. In particular, making reference to figure 1 b, said coupling device 3 has an elongate shape comprising a grip area 30 adapted to allow it to be gripped by the operator and an end portion 33 adapted to be coupled to said hole 20 of said flange 2. Said grip area 30 can comprise a handle element 300 adapted to be more firmly gripped in order to allow a larger pulling force to be exerted.

[0089] Furthermore, said coupling device 3 comprises a magnet 31. In particular, said magnet 31 can be positioned in proximity to said end portion couplable to said flange 2 or it can be movable inside an internal channel that passes through said coupling device 3 for the whole length thereof. In the latter case, said magnet 31 can be positioned at different heights, based on the needs at the operating time.

[0090] Said coupling device 3 can be coupled to said flange 2 via coupling means. Preferably, said coupling means consist of anchorage grippers. Said anchorage grippers can be fixed onto said coupling device 3 and be engaged to said flange 2, for example by means of grooves along the outer margin of said flange 2 which will allow the anchorage grippers to be locked and released. Alternatively, the flange can have grippers to be engaged to the coupling device 3. More preferably, as shown in figure 2, said coupling means consist of a rigid structure 23 fixed onto said flange 2. In particular, making reference to figure 2, said rigid structure comprises vertical supports, adapted to distance said hole 20 from the coupling device 3, connected to a flat support comprising a housing for the end portion of said coupling device 3. Therefore, said rigid structure 23 allows the housing of said coupling device 3, while keeping it at a distance from said hole 20 of said flange 2. Furthermore, the housing present in said rigid structure is such as to enable the operator to maintain a view over the operating point and to enable the rotation of said coupling device 3 if necessary.

[0091] Said device 1 can further comprise support means adapted to prevent pressure from being applied on the trachea at the moment in which said coupling device 3 is attached to said flange 2 positioned on the trachea. With particular reference to figure 3, in a first embodiment, said support means are support legs 21 fixed directly onto said flange 2. Said support legs 21 , when in use, rest stably on a supporting base 22, wherein said supporting base 22 can be a resuscitation procedure plate. Said support legs 21 are preferably adjustable so as to be able to exert pressure, during the procedure, without crushing the patient’s trachea.

[0092] In a second embodiment, not shown, said support means are support legs fixed directly to said coupling device.

[0093] Again making reference to figures 4-5, said device 1 further comprises a needle 5 adapted to perforate the patient’s trachea and a needle housing adapted to engage said needle 5, for example a concave housing capable of accommodating the tip of the needle. Said needle 5 can be a straight or semi-curved needle, for example with a microscopic tip and then an increasing diameter. Said housing can consist, for example, of a microcapsule adapted to accommodate the tip of the needle 5. Said housing preferably comprises a fitting system, for example a snap-fit system, adapted to fix the tip of the needle 5 in the housing thereof. In particular, in one embodiment, not shown, said fitting system comprises a concave base resting on a portion of a ring adapted to enter a through hole of said needle, said through hole being positioned at a short distance from the tip of the needle.

[0094] Said needle 5 can alternatively be coupled in proximity to the front end B of said guiding thread 42 and to the front end 431 of the dilatative cannula 43, as shown in figure 4, or it can be coupled to the end portion 33 of said coupling device 3.

[0095] Said needle housing is thus placed at the end of said coupling device 3 adapted to be coupled to said flange 2 when the needle 5 is coupled to the front end B of said guiding thread 42 and to the respective front end 431 of the dilatative cannula 43 or is placed at the front end B of said guiding thread 42 and at the respective front end 431 of the dilatative cannula 43 when said needle 5 is coupled to the end of said coupling device 3 adapted to be coupled to said flange 2.

[0096] Therefore, the magnetic attraction between the magnet 31 present in said coupling device 3, positioned on said flange 2 outside the patient’s throat in proximity to said hole 20, and the end portion comprising metallic / magnetic material of the dilatative cannula 43 ensure that the needle 5, which can be present at the front end 431 of said dilatative cannula 43 or at the end of said coupling device 3, is attracted towards the needle housing that is on the other side of the skin, thus generating the formation of a tracheal hole F in the patient’s trachea.

[0097] Summing up the above: - according to a first embodiment (I), shown in figure 1 , the needle 5 is coupled to the end B of said guiding thread 42 and / or to the respective front end 431 of the dilatative cannula 43 and, together with the portion made of metallic / magnetic material of the dilatative cannula 43, will be attracted by the magnet 31 present in said coupling device 3, which comprises the needle housing at the end thereof, which can be positioned, for example, inside the magnet 31 itself; in this manner, the tracheal hole F will be made from the inside towards the outside by means of a manual push by an operator, since the needle 5 from inside the trachea will be coupled to the respective needle housing present on the outside, passing beyond the patient’s trachea and skin;

[0098] - according to a second embodiment (II), not shown, the needle 5 is coupled to the end portion of said coupling device 3 adapted to be coupled to said flange 2, for example the needle 5 can be housed in the magnet 31 , and the magnet 31 will attract the metal portion made of metallic / magnetic material of the dilatative cannula 43, whose front end 431 comprises the needle housing 51 ; in this manner, the tracheal hole F will be made from the outside towards the inside, since, from the outside of the patient’s throat, the needle 5 will be coupled to the respective needle housing present inside, passing beyond the patient’s trachea and skin.

[0099] In the above-described embodiment (I), said needle 5 attached to the front end B of the guiding thread 42 and / or of the dilatative cannula 43 can be actuated, for example, by pushing said guiding thread 42. In fact, in the embodiment (I) said guiding thread 42 comprises a semi-rigid steel cable.

[0100] In particular, the tip of said needle 5 can be protected by a thin pierceable membrane, so as to avoid accidental pricks or abrasions of the inner wall of the trachea. In fact, the tip of the needle 5 is adapted to protrude from the pierceable membrane only when an intentional thrust is exerted.

[0101] Making particular reference to figure 1 b, said magnet 31 can be lowered or raised with respect to the end of said coupling device 3 proximal to the flange 2 by means of movement devices, activated, for example, by a pushbutton or a trigger. For example, said movement devices can comprise a lever system comprising one or more toothed lifting wheels on a roller track, for example a track with teeth, pushed by an interlocking toothed wheel of the track. Moreover, said movement devices can comprise a piston or syringe, adapted to be manually activated. In this manner, the magnet 31 can move closer to and away from the sliding device 4 positioned in the trachea, with the aim of attracting it gradually to the point of interest, in order then to be brought to the maximum closeness during the prick step.

[0102] In one embodiment, not shown, the movement of the magnet can be controlled by a knob placed on the coupling device which will enable the operator of rotate it with his or her free hand, while holding the handle with the dominant hand.

[0103] In an alternative embodiment, not shown, the magnet is an electromagnet with a "trigger" control to regulate the magnetic intensity.

[0104] In particular, when said magnet 31 is aligned with the front end of said guiding thread 42 and of said dilatative cannula 43, they are attracted to each other, indicating to the operator the point where the prick should be performed in the area of interest. More particularly, when said magnet 31 is an electromagnet, said coupling device 3 can comprise a trigger adapted to regulate the passage of current in the electromagnet. In fact, when said magnet 31 is aligned with the front end of said guiding thread 42 and of said dilatative cannula 43, they will be attracted to each other based on the pressure exerted on said trigger, enabling the operator to perform the prick in the area of interest.

[0105] Once the tracheal hole F has been made by means of said needle (from the inside towards the outside or vice versa), said dilatative cannula is adapted to be extracted from the hole from the inside towards the outside, in order to dilate said tracheal hole F. According to the invention, said dilatative cannula, in the use configuration, is characterised by an increasing diameter starting from the end attached to the front end B of the guiding thread, i.e. the end turned towards the patient’s trachea during the perforation of the trachea, towards the opposite end.

[0106] Making particular reference to the embodiments shown in figure 5, said dilatative cannula 43 can be a telescopic dilatative cannula (figure 5A), i.e. made up of a series of concentric cylindrical sections (or pipes) 430 capable of being positioned one inside the other, that is, wherein each cylindrical section 430 is capable of incorporating the adjacent section with a smaller diameter and wherein the section with the smallest diameter is the section adapted to be turned towards the patient’s trachea during the perforation of the trachea. In particular, said telescopic dilatative cannula 43 preferably comprises a wire 438 attached to the section with the largest diameter. Said wire is adapted to be pulled to enable said dilatative cannula 43 to bend, when attracted by the magnet 31 , in order to turn its end towards the patient’s trachea. In an alternative embodiment (figure 5B) said dilatative cannula is a dilatative cannula having a truncated cone shape with an increasing diameter.

[0107] The maximum diameter that the dilatative cannula 43 can have is the inner diameter of the ventilation pipe V.

[0108] Said dilatative cannula 43 is preferably endowed with a plurality of notches on one side of its surface in proximity to the front end 431 attached to the end B of the guiding thread, i.e. in the point where it will have to bend, attracted by the magnet 31 , in order that its end will be turned towards the patient’s trachea. Furthermore, said dilatative cannula 43 can contain, in the front end 431 thereof, a small amount of anaesthetic and / or vasoconstrictor gel to be released in the point of contact to be pricked. Alternatively, said dilatative cannula 43 can have passing through it, for its entire length, a specific passage channel for aspiration or inoculation, to be used, therefore, also for the passage of said gel from the proximal access.

[0109] In particular, in the event that the dilatative cannula is not telescopic but is rather a truncated cone of increasing diameter, it can be provided with further separate internal routes, also positioned inside the wall of said dilatative cannula; said routes are adapted to be dedicated to other functions, such as the passage of said gel. In particular, said dilatative cannula can comprise an internal channel dedicated to the passage of a catheter provided with a balloon inflatable with air, to be used as a support to the sliding device during the perforation step, and useful for pushing the cannula upwards, towards the tracheal wall to be perforated.

[0110] According to the present invention, once the tracheal hole F has been made, by virtue of the magnetic coupling of the needle 5 with the needle housing, said dilatative cannula 43 of said sliding device 4 is extracted from the tracheal hole F starting from the end B of said guiding thread 42 attached to the end of the dilatative cannula 43. In this manner, the dilatative cannula 43 can be extracted towards the outside with the effect of gradually dilatative the tracheal hole F up to a maximum diameter. The maximum diameter of dilation can correspond to the diameter of the back end 432 of the dilatative cannula 43 or to a point of the dilatative cannula 43.

[0111] Said coupling device 3 can internally comprise a winding system, for example a roller or reel capable of gradually incorporating the guiding thread 42 and the dilatative cannula 43, as the latter are extracted from the hole. This allows the operator to be safeguarded, without making him or her come into direct contact with organic liquids. Furthermore, said winding system can be electronic or mechanical with a spring system. Furthermore, said device 1 can comprise a bag ready for the disposal of the sliding device 4 once it has exited from the tracheal hole F and suitable for avoiding possible discharges of organic liquids. Said bag is preferably coupled to said coupling device 3.

[0112] Once the maximum dilation brought about by dilatative cannula 43 is reached, said dilatative cannula 43 can be cut (leaving the guiding thread 42 intact). In particular, said dilatative cannula 43 can be cut in a dilatative portion provided with a housing for atraumatic dilatative forceps, so as to obtain the right diameter of the tracheal hole F. In fact, the tracheal hole must have a diameter adapted to allow the correct insertion of the tracheostomy cannula that will subsequently take place. Therefore, following the extraction of said dilatative cannula up to the necessary diameter, said hole F can be further dilated manually by using forceps.

[0113] Alternatively, for the further dilation of the tracheal hole F said device 1 can further comprise dilatative means 45.

[0114] Said dilatative means 45 can comprise, for example a dilatative ring 45. The dilatative ring 45 will remain in the cutaneous / tracheal plane to bring about the last, decisive dilation of the tracheal hole F and enable a uniform circular dilation with the surface in contact with the tissues. Making particular reference to figures 6 and 7, said dilatative ring 45 is an atraumatic expandable ring attached to the inner walls of the dilatative cannula 43 in proximity to the back end 432 thereof. Therefore, once the maximum dilation has been reached, the dilatative cannula can be cut so as to isolate the portion containing the dilatative means.

[0115] In the embodiment shown in figure 7, said dilatative ring 45 comprises a body 48 having a circular shape with a central hole and consisting of two separable semicircular halves 480 with two metal strips 481 passing through them, wherein each metal strip 481 passes through both the semicircular halves, as shown in Figure 7b. Said metal strips 481 are provided with grooves and / or toothed notches and are housed inside the casing in two cavities provided with counter-toothing adapted to allow the sliding the metal strip in a single direction (opening) when pressure is exerted with the aim of separating the two semicircular halves 480 of said ring 45.

[0116] Said ring can be dilated by using a forceps with two or more arms, wherein said forceps is capable of coming into contact with the inner surface of the ring, for example in proximity to specific seats, without, therefore, coming into direct contact with the tissues. Said forceps can be directly incorporated into said coupling device 3.

[0117] In an alternative embodiment shown in Figure 6, said dilatative ring 45 comprises a casing 450, for example made of silicone material or elastic material, and comprises a preformed metal strip 451 tending to open, in particular a pipe clamp adapted to widen, said strip being provided with grooves and / or notches, adapted to receive teeth of a toothed wheel 452 to be rotated manually, for example by means of an insertable tip, for example a screwdriver, placed internally, which will exert an action of advancing the portion of the strip that is inserted in said mechanism. The rotation of the toothed wheel 452 by means of the rotation of the housing adapted to receive the tip of a screwdriver or of a hex key will result in a dilation of the inner diameter of the dilatative ring 45, which can initially be forcibly compressed into a size with a smaller diameter.

[0118] In addition, said dilatative means, and in particular said dilatative ring 45, can comprise a plurality of locking tabs adapted to secure the dilatative ring 45 to the inner walls of the trachea. Said locking tabs can be, for example, of butterfly-like tabs, or a small cuffable portion, or a balloon inflatable with air, adapted to form a circular thickness around the hole through an increase in diameter. Said locking tabs, once activated, after the back end 432 of the dilatative cannula 43 has exited from the ventilation pipe V, will open and ensure that the dilatative ring 45 remains secured to the inner walls of the trachea. Said locking tabs 453 can be closed again in the event that problems occur, or after the conclusion of the procedure. For example, said dilatative ring 45 comprising the locking tabs 453 can be in a disassemblable form, so that, in order to remove it, it can be disassembled into at least two parts, which will be extracted.

[0119] Furthermore, said dilatative ring can also be dilated by means of a balloon expandible with water, for example activated by a high-pressure pump.

[0120] In one embodiment, not shown, said dilatative means can comprise an umbrella system, which, after partial extraction with an associated pre-dilation, will open inside the end part of said dilatative cannula, thereby increasing its diameter to the right size. In particular, said umbrella system comprises an internal wire attached to said back end of the dilatative cannula. Thus, pulling the internal wire will cause the arms to open like an umbrella, thereby increasing the diameter of the cone. A further embodiment, not shown, comprises both the umbrella system and the dilatative ring in order to make the opening more solid and secure.

[0121] Furthermore, making reference to figures 8a and 8b, said dilatative means 45 can comprise a second dilatative cannula 47 comprising a front end 471 and a back end 472.

[0122] In a first embodiment shown in figure 8a, said second dilatative cannula 47 is adapted to enter into said dilatative cannula 43 through a longitudinal notch 433 at the back end 432 of said dilatative cannula 43. In particular, said front end 471 of said second dilatative cannula 47 has a smaller diameter than said back end 472 and equal to the diameter of said front end 431 of said dilatative cannula 43.

[0123] Furthermore, again making reference to the embodiment shown in figure 8a, said second dilatative cannula 47 comprises a traction wire 473 attached to said front end 471 and adapted to slide inside said dilatative cannula 43 so as to come out from the tracheal hole F. In fact, through a pulling force exerted from outside the tracheal hole with said traction wire 473, for example made of steel, said second dilatative cannula 47 is adapted to further dilate the first dilatative cannula 43, thereby considerably increasing its diameter, until arriving at a set maximum width.

[0124] Making reference to the embodiment shown in figure 8b, said second cannula 47 is attached to said guiding thread 42 and is positioned downstream of the front end 431 of said dilatative cannula 43. In particular, said guiding thread 42 can pass through the front end 431 of said dilatative cannula 43 and the front end 471 of said second dilatative cannula 47, coupling them so that when said front end 431 of said dilatative cannula 43 is attracted by said magnet, it will enable a coupling between the needle and housing and the creation of the tracheal hole, while generating a further dilation given by the passage of said dilatative cannula 43 and of said second cannula 47 positioned side by side through the tracheal hole F.

[0125] Furthermore, said second dilatative cannula 47 can comprise, at the back end 472, a water-filled and / or high-pressure cuffable covering to increase the diameter.

[0126] In the embodiment shown in figures 9a and 9b, said sliding device 4 further comprises a guide 44 for the controlled insertion of the tracheostomy cannula. The guide 44 is adapted to facilitate the introduction of the tracheostomy cannula, eliminating the possibility of bending of the guide 44 and of creating false routes. Said guide 44 has a hollow cylindrical shape and, like the whole sliding device 4, is adapted to be introduced into the patient’s ventilation pipe V. In particular, said tubular shaped guide 44 can have a diameter almost equal to the inner diameter of the ventilation pipe, being able in any case to slide inside it. Said guide 44 has a front end 441 , attached to said guiding thread, and a back end 440. In particular, as shown in Figs. 9a and 9b, said guide 44 can have a pointed conical portion in proximity to said front end 441 , to allow an easier exit thereof. Furthermore, said guide 44 can comprise a hole for the passage of the air in said pointed conical portion. Making reference to the guiding thread 42, starting from the front end B of the guiding thread towards the back end A, the guide 44 is positioned downstream of the dilatative cannula 43. The guiding thread placed between the back end 432 of the dilatative cannula 43, i.e. the end with a larger diameter, and the front end 441 of the guide 44 has a length such that, when the dilatative cannula 43 is inserted into the trachea in the working position, i.e. with the front end 431 positioned in proximity to the flange 2 attached to the outside, the guide 44 is outside the patient’s mouth. Therefore, the length of the portion of guiding thread placed between the back end 432 of the dilatative cannula 43 and the front end 441 of the guide 44 has a length equal at least to the distance between the point in which the flange 2 is positioned and the area located in proximity to the patient’s mouth.

[0127] As shown in figure 9A, said guide 44 is adapted to be inserted, once said dilatative cannula 43 has been extracted from the tracheal hole F, into the patient’s mouth through the ventilation pipe V, starting from the back end 440 of the guide 44. Once the back end 440 of the guide 44 is inserted into the ventilation pipe V, it will be sufficient to pull the front end B of the guiding thread so that said guide 44 slides in the trachea until the front end 441 of the guide 44 is positioned in proximity to the tracheal hole F, as shown in figure 9B. Subsequently, the front end 441 of the guide 44 can be extracted from the tracheal hole F in order to be inserted into the tracheostomy cannula, acting as a guide therefor, during the whole of its final positioning. Said guide can subsequently be extracted once the cannula has been positioned.

[0128] Said guide 44 can comprise a sheathing made of soft plastic material that is folded and fixed in its folded configuration along the outer side of said guide 44, in particular in proximity to the back end 440 of said guide 44, which will come out first from the hole.

[0129] Said sheathing is adapted to be opened at the moment when the back end 440 of said guide 44 comes out and, in the open configuration, it extends around said guide 44 so as to be positioned between the guide 44 and the tissue of the patient’s trachea. The sheathing performs, in fact, a function of protecting the inner wall of the trachea and subsequently remains engaged to the distal end of the guide 44, in order then to be extracted from the tracheostomy cannula together with the guide 44 itself. In particular, the sheathing can comprise a plastic or fabric tape, attached to the outer wall of the guide, adapted to maintain the sheathing in its folded configuration, adherent to the outer wall of the guide. Said tape can be disengaged by the operator in order to bring the sheathing into its open configuration. More in particular, during use the tape is kept upward with respect to the semirigid guide that will be introduced into the tracheostomy cannula. In particular, as the tracheostomy cannula is inserted, it will be possible to extract the guide carrying the sheathing anchored at the end thereof. Subsequently, while holding the guide firm, it will be possible to introduce the tracheostomy cannula and extract the guide.

[0130] In addition, said guide 44 can comprise holes adapted to ensure the regular passage of air to the lungs.

[0131] Moreover, said guide can comprise a directional membrane adapted to ensure that said guide is not lifted upwards, that is, towards the mouth, even if subjected to a strong, sudden air pressure as in the case of coughing. A downwards displacement, on the other hand, is avoided by virtue of the guiding thread already secured outside the tracheal hole F. In particular, said directional membrane can comprise a bicuspid valve which will prevent the passage of a jet of air if it is in opposition to the tip of the adjacent tabs, whereas it will allow air to pass if directed from the base of the valve towards their tips.

[0132] Furthermore, said tape can be made of materials adapted to render the passage slippery in order to reveal any bleeding and / or contain specific medications such as vasoconstrictors or antihemorrhagic drugs.

[0133] In addition, said guide is dimensioned so as to allow said guide to be drawn back by the dilatative cannula, without remaining trapped between the cannula and the tracheal hole F.

[0134] Moreover, making reference to figures 9a and 9b, said sliding device 4 can comprise a safety element 46 coupled to said guiding thread 42 at said front end

[0135] 441 of said guide 44. In particular, said safety element 46 enables the operator to quickly remove the sliding device 4 from the ventilation pipe V in the event of problems during the procedure.

[0136] Said sliding device 4 can further comprise an inlet support positioned at the entry of the ventilation pipe V. Said inlet support preferably comprises a clamp consisting of two rollers which allow controlled sliding, in both directions, and the stopping and advancement of said sliding device 4 through the ventilation pipe V. Furthermore, said support can comprise a means for transmitting information or electric signals (by wire or Wi-Fi) to coordinate the various functions of the device which will accommodate the re-entry of the piercing or dilatative sections. Such information / signals will be marked (audible signals) and precise, thanks to preconfigured notches along the sliding sections, which will be easily kept under control by the operator, who will be facilitated by any lighting and magnified view provided in the functions of said support.

[0137] In particular, said notches provide a precise indication of the point emerging from the ventilation pipe and, consequently, the amount by which it emerges from the opposite side can be deduced, considering that the ventilation pipe has standard sizes.

[0138] Making reference to one embodiment, not shown, said coupling device can comprise, at the end located in proximity to the trachea, a pushing system. Said pushing system comprises at least two pincer-like arms adapted to oppose the skin that is everted due to passage of the exiting sliding device and adapted to exert a counterthrust on the skin, which will tend to be everted during the extractive / dilatative step performed by said exiting sliding device.

[0139] In particular, said at least two arms are adapted to switch from a first configuration of disengagement from to a second configuration of coupling with said dilatative ring wherein said at least two arms are crossed so as to allow the extraction of said dilatative cannula.

[0140] Moreover, the dilation of the dilatative ring will be modulated by said arms turned towards the inside of the entry hole thereof (with a ball I wheel I blade made of silicone at the end) and adapted to expand, opposing the spring I elastic system which push to close them, also during the passage between them of the sliding device emerging from the hole created.

[0141] In addition, said arms can be pushed downwards in an intermittent mode, either automatically (in the case of an electric / electronic / automated device) or mechanically, by slightly lifting the coupling device and bringing it closer if released from the flange.

[0142] Moreover, said arms allow the tissues of the trachea brought upwards by the emerging push to remain on their physiological plane. The described mechanism will facilitate the dilation of the tissues, while also avoiding problems and injuries to the cartilaginous rings.

[0143] Furthermore, the configuration of the coupling device 3 is dimensioned so as to enable the operator to have a continuous view of the point of operation and also allows an aspiration pipe or tampons to be introduced manually in the case of any bleeding.

[0144] Said device 1 can comprise at least one micro blade positioned on said coupling device 3, adapted to create small incisions in the skin during the first dilation step. In particular, the skin everted by the push of the exiting device creates a “mould” effect when the skin is pressed towards the blades protruding inside the concave housing.

[0145] Finally, said device 1 can contain voice commands, illumination, sensors, video cameras and lights, connected to each other for example via a wireless connection to help the operator. Furthermore, said device 1 can comprise dilatative forceps or hex keys, a screwdriver or the like which could be necessary in the last dilation step and could be included in said coupling device 3.

[0146] The present invention has been described by way of non-limiting illustration according to preferred embodiments thereof, but it is to be understood that variations and / or modifications can be introduced by the person skilled in the art without going outside the scope of protection hereof, as defined by the appended claims.

Claims

CLAIMS1 ) A device (1 ) for creating a tracheal hole (F) for the tracheotomy procedure, said device (1 ) being characterised in that it comprises:- a sliding device (4) adapted to be introduced through a ventilation pipe (V) used for ventilation of the patient, said sliding device (4) comprising- a guiding thread (42), preferably a metal cable, adapted to enter from said ventilation pipe (V) and to exit from the tracheal hole (F),- a dilatative cannula (43) with a substantially tubular shape, comprising a front end (431 ) attached to said guiding thread (42) and a back end (432), said front end (431 ) of the dilatative cannula (43) having a diameter that is smaller than the diameter of said back end (432) of the dilatative cannula (43), said dilatative cannula (43) comprising at least one metal portion made of a metallic material adapted to be attracted by a magnet or at least one magnetic portion at said front end (431 ), said sliding device (4) alternatively comprising- a needle (5) coupled to said front end (431 ) of said dilatative cannula (43) or- a housing adapted to hook onto a needle, said housing being positioned near to the front end (431 ) of said dilatative cannula (43), wherein said at least one metal or magnetic portion of said dilatative cannula (43) is adapted to be attracted by a magnet placed outside the trachea, so as to allow the coupling of said needle (5) with said magnet or of said housing with a needle coupled to said magnet, thereby creating said tracheal hole (F) and generating a relative dilation of said tracheal hole (F) through the passage of said dilatative cannula (43).2) The device (1 ) according to the preceding claim, characterised in that said guiding thread (42) comprises a back end (A), a front end (B) and at least one metal portion, at said front end (B), made of a metallic material adapted to be attracted by a magnet, said dilatative cannula (43) being attached to said front end (B) of said guiding thread (42).3) The device (1) according to one of claims 1 and 2, characterised in that it further comprises: a coupling device (3) comprising an end portion (33) adapted to becoupled to a hole (20) of a flange for tracheostomy, said coupling device (3) comprising a magnet (31 ), wherein- said needle (5) is coupled alternatively to one of said front end (431 ) of said dilatative cannula (43) and said end portion (33) of said coupling device (3), and wherein- said housing adapted to hook onto said needle (5) is positioned in proximity to the end portion (33) of said coupling device (3) when said needle (5) is coupled to the front end (431 ) of said dilatative cannula (43), or is positioned in proximity to the front end (431 ) of said dilatative cannula (43) when said needle (5) is coupled to the end portion (33) of said coupling device (3).4) The device (1 ) according to any one of the preceding claims, characterised in that said sliding device (4) comprises a guide (44) with a substantially tubular shape, positioned downstream of the back end (432) of said dilatative cannula (43), said guide (44) comprising a front end (441 ) and a back end (440), said front end (441 ) being attached to said guiding thread (42), wherein said guide (44) is adapted to be introduced into the ventilation pipe (V) at said back end (440) of said guide (44).5) The device (1 ) according to any one of the preceding claims, characterised in that said dilatative cannula (43) and / or said guide (44) have a hollow cylindrical shape.6) The device (1 ) according to the preceding claim, characterised in that said guiding thread (42) passes through said dilatative cannula (43) and / or said guide (44).7) The device (1 ) according to any one of claims 3-6, characterised in that said magnet (31 ) comprises alternatively said housing and said needle (5).8) The device (1 ) according to any one of the preceding claims, characterised in that said sliding device (4) comprises dilatative means (45) coupled to said dilatative cannula (43).9) The device (1 ) according to claim 8, wherein said dilatative means (45) comprise a second dilatative cannula (47) comprising a front end (471 ) and a back end (472), said front end (471 ) having a diameter equal to the diameter of said front end (431 ) of said dilatative cannula (43) and preferably having a smaller diameter than said back end (472) of said second dilatative cannula (47), said front end (471 )of said second dilatative cannula (47) being adapted to enter into said dilatative cannula (43) at the back end (432) of said dilatative cannula (43), said dilatative cannula (43) comprising, in proximity to the back end (432), a longitudinal notch (433) adapted to favour the entry of said second dilatative cannula (47), said second dilatative cannula (47) comprising a traction wire (473) attached to the front end (471 ) of said second dilatative cannula (47) and adapted to slide inside said dilatative cannula (43).10) The device (1 ) according to claim 8, when dependent on claim 2, wherein said dilatative means (45) comprise a second dilatative cannula (47) comprising a front end (471 ) and a back end (472), said front end (471 ) having a smaller diameter than said back end (472) of said second dilatative cannula (47), said second dilatative cannula (47) being attached to said guiding thread (42) in proximity to the front end thereof (471 ) so that the front end (471 ) of said dilatative cannula (43) and the front end (471 ) of said second dilatative cannula (47) are substantially adjacent to each other and both attached to said guiding thread (42).11 ) The device (1 ) according to any one of the preceding claims, characterised in that said dilatative cannula (43) and / or said second dilatative cannula (47) is a telescopic dilatative cannula comprising a series of cylindrical sections (430) with an increasing diameter, said cylindrical sections (430) being adapted to switch from a closed configuration, in which they are positioned one inside the other, to an open configuration, in which they are positioned, partly overlapping, one after the other.12) The device (1 ) according to any one of claims 8-11 , wherein said dilatative means (45) comprise an atraumatic expandable ring adapted to allow a uniform circular dilation and fixed on said back end (432) of said dilatative cannula (43).13) The device (1 ) according to any one of the preceding claims, characterised in that it further comprises a flange (2) comprising a hole (20) adapted to be positioned around the patient’s neck.14) The device (1 ) according to any one of claims 3-13, characterised in that it comprises coupling means for coupling said coupling device (3) with a flange (2).

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