WO2002020077A1

WO2002020077A1 - Apparatus and method for performing percutaneous tracheostomy

Info

Publication number: WO2002020077A1
Application number: PCT/IT2001/000457
Authority: WO
Inventors: Gianmario Monza
Original assignee: LEGRIX Ltd
Current assignee: LEGRIX Ltd
Priority date: 2000-09-05
Filing date: 2001-09-04
Publication date: 2002-03-14
Anticipated expiration: 2003-03-05
Also published as: ITBO20000510A0; AU2001292217A1; ITBO20000510A1

Abstract

Apparatus (1) and method for performing percutaneous tracheostomy, according to which a tubular tracheoscope (2) fitted with an illumination device (14) and an optical inspection device (12) is partially insertable into a trachea and houses a sliding perforation and traction element; the perforation and traction element (21) exits by means of a guide device (19, 20) from one end of the tubular tracheoscope (2) to perforate an intra-annular space of the trachea from the inside to the outside.

Description

"APPARATUS AND METHOD FOR PERFORMING PERCUTANEOUS

TRACHEOSTOMY"

TECHNICAL FIELD This invention relates to an apparatus for performing percutaneous tracheostomy. BACKGROUND ART

Percutaneous tracheostomy is a method used in medicine to accomplish a stoma in an intra-annular space of the trachea of a patient and to position a tracheostomy tube through the stoma with the purpose of assuring ventilation of the airways. According to a known method called translaryngeal tracheostomy, the tracheostomy is performed with an apparatus comprising a tracheoscope which is introduced in the mouth until entering the trachea, and a needle/cannula which is inserted through the trachea from the inside to the outside. The said tracheoscope comprises a straight rigid tube into which a visual endoscope can be inserted fitted with an optical probe and a light source. The endoscope allows, thanks to endoscopic vision and transillumination of the tissues through the light source, identifying the intra-annular space in which to insert the needle/cannula from the outside to the inside until positioning it inside the said rigid tube .

The said apparatus moreover comprises a traction wire which, after inserting the needle/cannula in the rigid tube, is introduced through the lumen of the needle/cannula and pushed inside the rigid tube until one end of the traction wire exits from the mouth.

The end of the traction wire is then inserted in a tracheostomy tube fitted at one end with a dilating cone/cannula and is subsequently enlarged, normally by means of a knot. In this way, after removing the needle/cannula and the tracheoscope, a pulling action is performed on the free end of the traction wire coming out of the stoma in such a way that the tracheostomy tube is drawn through the mouth until entering the trachea and is extracted from the inside to the outside thanks to the progressive dilatation of the dilating cone/cannula.

The use of the said apparatus in performing percutaneous tracheostomy presents a serious problem, in particular when the neck of the patient is very thick. In effect, introducing the needle/cannula from the outside to the inside may lead to staggering of the subcutaneous tissue planes caused by the inevitable pressure that is exercised on the skin. Consequently, when the tracheostomy tube is replaced, normally every six or seven days, the subcutaneous tissue planes tend to readjust and, given that the percutaneous stoma tends to close in a short period of time, it is difficult to insert a new tracheostomy tube through the existing stoma.

DISCLOSURE OF INVENTION The purpose of this invention is to provide an apparatus for performing percutaneous tracheostomy, which does not create the problem described above and which, moreover, is easy and inexpensive to make. According to this invention, an apparatus for performing percutaneous tracheostomy is provided as asserted in Claim 1.

This invention moreover relates to a method for performing percutaneous tracheostomy. According to this invention, a method for performing percutaneous tracheostomy is provided as asserted in Claim 24.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described with reference to the annexed drawings, which illustrate some examples of unrestrictive implementation, in which:

- Figure 1 schematically illustrates, with sections removed for the sake of clarity, a side view of an apparatus for performing percutaneous tracheostomy according to the principles of this invention in a first operating position;

- Figure 2 is an enlarged cross-section of a detail of

Figure 1 ;

- Figure 3 is an enlarged cross-section of Figure 2 along the line III-III;

- Figure 4 is an enlarged cross-section of a detail of

Figure 1 ; - Figures 5 and 6 illustrate an enlarged cross-section, with sections removed for clarity, of a detail of Figure 1 in two different operating positions;

- Figure 7 illustrates an alternative form of implementation of an apparatus according to this invention in a first operating position;

- Figure 8 is an enlarged cross-section of Figure 7 along the line VIII-VIII;

- Figures 9 to 14 illustrate respective details of Figure 1 in six different operating positions.

BEST MODE FOR CARRYING OUT THE INVENTION With reference to Figure 1, 1 as a whole indicates an apparatus for performing percutaneous tracheostomy.

The apparatus (1) comprises a tracheoscope (2) and a control device (3) to which, during use, an end section (2a) of the tracheoscope (2) is connected.

As better illustrated in Figures 5 and 6, the tracheoscope (2) comprises an elongated tubular body (4) which extends along a longitudinal axis (5) , is made of a semi-rigid material and has, in correspondence to its end section (2b) opposite the end section (2a) a curved extension (6) which extends from one section of the periphery of the tubular body (4) and defines a mouthpiece (7) . The tubular body (4) comprises a ventilation channel (8) coaxial with the axis (5) and connectable, during use, to a ventilation device (9) (Figure 1) . As better illustrated in Figure 3 , the tubular body

(4) has, in correspondence to its internal walls, a longitudinal groove (10) which extends parallel to the axis (5) and defines an area of lesser width of the tubular body (4) .

The tubular body (4) moreover comprises various channels extending parallel to the axis (5) and with the same width as the tubular body (4) and include a channel

(11) in which an optical probe (12) can be inserted, three channels (13) in which respective optical illumination fibres (14) are inserted, an insufflation line including a channel (15) in which a tube (16) is inserted, and four aspiration and/or washing channels (17) which, during use, can be utilised to wash one end of the optical probe (12) , to wash the mouthpiece (7) or to aspirate secretions which deposit on the optical probe

(12) and in the mouthpiece (7) . The channels (13) are uniformly distributed along the periphery of the tubular body (4) in such a way that one channel (13) extends along the extension (6) and the relevant optical fibre (14) extends up to the end of the extension (6) (Figures 5 and 6) .

The number of channels (13) and the relevant optical fibres (14) , the number of channels (17) , the number of channels ('11) and the respective optical probes (12) is indicated by way of unrestrictive example and may vary depending on requirements . The tracheoscope (2) comprises an inflatable external peripheral cuff (18) (Figures 5 and 6) communicating with the tube (16) and positioned in proximity of the extension (6) of the tracheoscope. The tracheoscope (2) moreover comprises a tubular guide (19) which extends parallel to the axis (5) , is fixed inside the channel (8) and is arranged with its curvilinear end section along the extension (6) .

A rectilinear, flexible and elastically deformable tube (20) - made, for example, of polyethylene - slides inside the tubular guide (19) . The tube (20) in its turn defines a tubular guide for a perforation and traction element (21) , which is mounted axially sliding along the tube (20) and, together with the tube (20) constitutes part of the tracheoscope (2) .

The perforation and traction element (21) comprises a rectilinear needle (22) made of elastically deformable material, and a steel traction wire (23) securely connected to one end of the needle (22) . The wire (23) has a cylindrical enlargement (24) securely connected to one end (Figure 4) .

The apparatus (1) comprises a tracheostomy tube (25) which, as better illustrated in Figure 4, extends along a longitudinal axis (26) and, during use, the tube (20) and the perforation and traction element (21) slide inside it. The tracheostomy tube (25) comprises a cannula (27) made of a flexible material, across whose width a spiral stiffening spring (28) is inserted, and it has an internal cylindrical channel (29) coaxial with the axis (26) with a certain diameter greater than the diameter of the cylindrical enlargement (24) .

The tracheostomy tube (25) moreover comprises a penetration element (30) which is coupled to one end

(27a) of the cannula (27) and is fitted, in correspondence to a peripheral section of the end (27b) opposite the end (27a) , with an inflatable cuff (31) (Figure 1) .

The cuff (31) is connected to an air adduction tube (32) which extends parallel to the axis (26) and is arranged for most of its length across the width of the cannula (27) , while one end section including a nonreturn valve (known and not illustrated) is inserted in the channel (29) .

The penetration element (30) comprises a detachable flexible dilating cone/cannula (33) coupled to the end (27a) of the cannula (27) by means of a threaded coupling. The cone/cannula (33) has an internal cylindrical channel (34) coaxial with the axis (26) with a diameter smaller than the diameter of the channel (29) and the diameter of the cylindrical enlargement (24) . Moreover, the cone/cannula (33) is fitted with a metallic insert (35) in correspondence to the penetration tip. The apparatus (1) also comprises a safety wire (36) (Figure 2) , preferably a silk wire, one end of which, during use, is connected to the end (27a) of the cannula (27) . The control device (3) comprises a multifunction gun (37) as illustrated in Figure 1.

The gun (37) comprises a control lever (38) selectively connectable - in a known manner and not illustrated - by means of a mobile selector (39) between two positions A and B, to the tube (20) or to the perforation and traction element (21) , respectively.

Furthermore, the gun (37) is fitted with a terminal

(40) connectable to a light source (41) and an eyepiece

(42) connectable to the optical probe (13) . The gun (37) , as better illustrated in Figures 2 and

3, comprises a tubular body (43) extending along an axis

(44) and defining the barrel of the gun (37) , inside which a seat (45) has been cut to house, during use, the end section (2a) of the tracheoscope (2) and the tracheostomy tube (25) .

The gun (37) comprises a releasable tubular cap (46) coupled, to the tubular body (43) by means of a bayonet joint (47) of known type.

The cap (46) has a channel (48) coaxial with the axis (44) and houses an end section (43a) of the tubular body (43). The gun (37) moreover comprises a cutting element (49) which is coupled to the cap (46) and is movable between a rest position (indicated with a solid line in Figures 2 and 3) and an operating position (indicated with a broken line in Figure 3) .

The cutting element (49) comprises a blade (50) securely connected to a button (51) by means of interposition of a rod (52) . The blade (50) is housed in the rest position inside a radial housing (53) cut across the width of the cap (46) and extending along an axis

(54) perpendicular to the axis (44) , while the rod (52) together with the button (51) remains almost completely outside the cap (46) . The cutting element (49) is maintained in the rest position by means of a spring (55) wound around the rod (52) and interposed between the button (51) and the outer wall of the cap (46) and by means of a catch (56) connected to the rod (52) which engages the housing (53) and is held in place against an appendix (57) extending parallel to the axis (44) by one side wall of the housing (53) .

The blade (50) has a cutting profile defined by a first inclined section (58) with respect to the axis (44) and a second concave section (59) arranged on a lateral end of the blade and defining a hook together with the inclined section (58) .

The end section (43a) has, in a position rotated by an angle of about 30° with respect to the axis (54) , a through slit (Figure 3) which extends parallel to the axis (44) along the entire extension of the section (43a) .

The apparatus (1) comprises a ventilation tube (61) (Figures 9-13) of known type, which is fitted with an inflatable cuff (62) at one peripheral end section. The tube (61) is moreover fitted with an air adduction line

(63) communicating with the cuff (62) and connectable, during use, to a pumping device (64) by means of interposition of a non-return valve (known and not illustrated) .

The apparatus (1) moreover comprises an obturator (65) (Figures 12-14) which, during use, is utilised to turn the cannula (27) from the cranial to the caudal position. The obturator (65) has a longitudinal channel (66) along which, as will be better explained below, the optical probe (12) can be inserted after it has been removed from the tracheoscope (2) . The obturator (65) is preferably made of a material able to transmit light, for example, polycarbonate, and can be connected to a light source

(known and not illustrated) .

According to an alternative form of implementation shown in Figures 7 and 8, in which the parts in common with the first form of implementation are indicated with the same reference numbers, the ventilation tube (61) forms part of the tracheoscope (2) and is connected to the tubular body (4) in such a way that it can be released. The tubular body (4) has an external longitudinal groove (67) which extends parallel to the axis (5) and houses the ventilation tube (61) . The ventilation tube (61) is held inside the groove (67) by means of a film (68) which extends along almost the entire length of the groove (67) , and is connected to the peripheral sections of the tubular body (4) adjacent to the groove (67) in such a way that it can be removed, and allows the ventilation tube (61) to slide along the groove (67) . Along the ends of the groove (67) without film (66) , the ventilation tube (61) is held in position by means of two elastic rings (68) integral to the tubular body (4) .

During use, the tracheostomy tube (25) , already connected to the safety wire (36) , is placed in the housing (45) with the tube (20) and the traction wire (23) fitted with the cylindrical enlargement (24) arranged along the channel (29) (Figures 2 and 4) .

The end section (2a) of the tracheoscope (2) is positioned in the housing (45) along the end section

(43a) of the tubular body (43) and securely connected, for example, by means of gluing to the inner wall of the housing (45) . Moreover, the tracheoscope (2) is arranged in the housing (45) in such as way that the groove (10) is set at an angle of about 30° with respect to the axis (54) and in correspondence to the slit (60) . Before inserting the tracheoscope (2) in the housing (45) , the optical probe (12) is connected to the eyepiece (42) (known and not illustrated) and inserted in the channel (11) . Moreover, the tube (20) and the wire (23) are connected - in a known manner and not illustrated - to the control lever (38) and the selector (39) , and the optical fibres (14) are connected - in a known manner and not illustrated - to the light source (41) . Subsequently, as illustrated in Figure 1, the tracheoscope (2) is partially inserted through the mouth of a patient in a supine position until entering the trachea with the end section (2b) with the mouthpiece (7) facing the upper wall of the trachea. The tracheoscope (2) is then locked into position by inflating the cuff (18) by means of a pumping device (70) which is connected by interposing a non-return valve (known and not illustrated) to the tube (16) .

During the subsequent phases, the patient is ventilated by connecting the ventilation channel (8) , known and not illustrated, to the ventilation device (9) .

Once the tracheoscope (2) has been introduced and the intra-annular space where the tracheostomy is to be performed identified thanks to the illumination and the endoscopic vision by means of the optical fibres (14) and the optical probe (12) , respectively, the lever (38) is operated with the selector (39) locked in position A, exercising an axial thrust on the tube (20) thus making it slide along the tubular guide (19) . During the advance along the tubular guide (19) , the tube (20) is bent in correspondence to the extension (6) , but being elastically deformable, it reacquires a rectilinear configuration when exiting from the tracheoscope (2) , thus being oriented towards the upper wall of the trachea. Hence the tube (20) is advanced until coming into contact with the upper wall of the trachea between two tracheal rings (Figure 5) .

Subsequently, after having checked through the eyepiece (42) that the end of the tube (20) is in the desired position, the selector (39) is set to position B and, operating the lever (38) , the perforation and traction element (21) is advanced along the tube (20) until the needle (22) exits which, like the tube (20) , reacquires a rectilinear configuration when exiting the tubular body (4) (Figure 6) .

When the needle (22) has exited it is drawn and subjected to traction.

Before starting traction, the tracheoscope (2) is extracted from the patient, the traction wire (23) released from the tube (20) , the tubular guide (19) and the tubular body (4) and the tracheostomy tube (25) is removed from the housing (45) (Figure 9) .

To disengage the traction wire (23) from the tube (20) , the tubular guide (19) and the tubular body (4) , the cap (46) of the gun (37) is rotated by about 30° in the direction indicated by the arrow C until one end of the housing (53) is positioned in correspondence to the slit (60) . In this position the cap (46) is uncoupled from the tubular body (43) and the cutting element (49) is moved from the rest position to the operating position by pushing the button (51) in the direction indicated by the arrow D. In this way, the blade (50) is made to slide in the slit (60) and is advanced until cutting into the tubular body (4) with the inclined section (58) in correspondence to the groove (10) . Continuing to push the button (51) , the blade (50) is arranged with the concave section (59) bridging the width of the tubular body (4) in such a way that, when pulling back the gun (37) and consequently the tracheoscope (2) to the outside, the tubular body (4) is cut longitudinally along the groove (10) .

Before proceeding with extraction of the tracheoscope (2) and. cutting of the tubular body (4) , the optical probe (12) is removed from the channel (11) to be reused and the cuff (18) is deflated.

Gradually, while proceeding with cutting of the tubular body (4) , the traction wire (23) is disengaged from the tubular guide (19) and the tube (20) , which preferably have longitudinal grooves (not illustrated) similar to the groove (10) to facilitate disengagement of the traction wire (23) . After completely extracting the tracheoscope (2) from the mouth and removing the optical probe (12) , the tracheoscope (2) , which is a single-use device, is disconnected from the gun (37) and sent to an authorised waste disposal site.

In a phase immediately following extraction of the tracheoscope (2) , the patient is intubated with the ventilation tube (61) which is connected to a ventilation device (71) and locked in proximity of the carinal bifurcation by inflating the cuff (62) (Figure 9) .

Subsequently, the perforation and traction element

(21) is subjected to traction from the outside in correspondence to the end of the needle (22) , the enlargement (24) slips into place in correspondence to one end of the channel (34) of the cone/cannula (33) , and the tracheostomy tube (25) is thus drawn into the trachea and induced to exit, first with the cone/cannula (33)

(Figure 10) and then with a section of the cannula (27)

(Figure 11) , from the patient thanks to progressive dilatation of the stoma.

In a subsequent phase, the cone/cannula (33) is unscrewed from the cannula (27) to which the safety wire (36) was connected before starting the operations (Figure 11) . The safety wire (36) which is connected to the cannula (27) and runs outside the cannula (27) is used as remedy in the event of failure of the extraction manoeuvre, i.e. in the event that the tracheostomy tube (25) exist completely, since the end of the safety wire (36) exiting the mouth can be connected to the traction wire (23) forming a ring in such a way that the tracheostomy tube (25) can be reinserted.

As illustrated in Figure 12, after unscrewing the dilating cone/cannula (33) , the obturator (65) is inserted in the channel (29) of the cannula (27) and connected to a light source (not illustrated) , and the optical probe (12) is inserted in the channel (66) of the obturator (65) . Subsequently, the obturator (65) is rotated to move the cannula (27) from the cranial position (Figure 12) to the caudal position (Figure 13) .

In a subsequent phase, the obturator (65) and the optical probe (12) are extracted from the cannula (27) and the cannula (27) locked on the outside by means of a retaining ring nut (72) of known type. Finally, the tube (32) is connected to a pumping device (73) in such a way as to inflate the cuff (31) and lock the cannula (27) inside the trachea, the ventilation tube (61) is extracted (Figure 14) and the cannula (27) connected to a ventilation device (71) .

Alternatively, if the tracheoscope (2) is made according to the form of implementation shown in Figures 7 and 8, during extraction of the tracheoscope (2) , the tube (61) is made to slide in the opposite direction along the groove (67) and, gradually while proceeding with extraction, it is separated from the tracheoscope (2) detaching the film (68) and severing the elastic rings (69) until positioning it as illustrated in Figure 9. The form of implementation where the ventilation tube (61) is coupled to the tubular body (4) in such a way that it can be removed is particularly advantageous since it avoids separate insertion of the tracheoscope (2) and the ventilation tube (61) . The apparatus (1) has many advantages for performing a percutaneous tracheostomy.

First of all, the fact that the needle (22) and then the traction wire (23) is introduced from the inside of the trachea to the outside is particularly advantageous, since in this way the tracheostomy can also be performed on very thick or short necks, given that no counterpressure needs to be exercised on the skin from the outside and hence the subcutaneous tissue planes are perforated radially, preventing the negative effect of misalignment of the subcutaneous planes.

Moreover, the apparatus (1) allows carrying out perforation and insertion of the tracheostomy tube (25) with fewer manoeuvres compared to known techniques and hence the whole apparatus can be maintained in better hygienic conditions .

Apart from the fact that the tracheoscope (2) is made of a semi-rigid material and is preformed to better favour the anatomy of the trachea, it is less harmful to the patient during introduction into the trachea and allows carrying out the introduction manoeuvre in better safety conditions compared to the use of a rigid tracheoscope .

A further advantage is that the optical probe (12) can be inserted in the channel (11) and, during use, can be fixed into position inside the tracheoscope (2) . This solution allows easier control over the endoscopic vision compared to a known solution where the endoscope is inserted in a rigid tracheoscope and must continually be positioned with respect to the rigid tracheoscope during execution of the stoma.

Claims

1. Apparatus for performing percutaneous tracheostomy- endoscopy comprising a tracheoscope (2) insertable in a trachea, illumination devices (14) and optical inspection devices (12) , the said tracheoscope comprising a first tubular body (4) extending along a first longitudinal axis (5) , the apparatus (1) being characterised by the fact that it includes a perforation and traction element (21) mounted in such a way that it slides inside the said first tubular body (4) to exit from one end of the first tubular body (4) in such a way as to perforate an intra- annular space of the trachea from the inside to the outside.

2. Apparatus according to Claim 1 in which the said tracheoscope (2) comprises guide devices (19,20) to orient the said perforation and traction element (21) towards the said intra-annular space.

3. Apparatus according to Claim 2 in which the said guide devices (19,20) comprise a tubular guide (19) fixed to the said first tubular body (4) extending along the said first tubular body

(4) parallel to the said first axis (5) , the said tubular guide (19) having a curvilinear end section. . Apparatus according to Claim 3 in which the said guide devices (19, 20) moreover comprise a rectilinear tubular element (20) made of an elastically deformable material, the said tubular element (20) being mounted in such a way that it slides along the said tubular guide (19) .

5. Apparatus according to Claim 4 in which the said perforation and traction element (21) is mounted in such a way that it slides along the said tubular element (20) .

6. Apparatus according to any of the preceding claims in which the said perforation and traction element (21) comprises a rectilinear needle (22) and a traction wire (3) securely connected to each other.

7. Apparatus according to Claim 6 in which the said needle (22) is made of an elastically deformable material .

8. Apparatus according to Claims 3-7 in which the said tracheoscope (2) is fitted, in correspondence to a first end section (2b) , with a curved extension (6) extending from one peripheral section of the said first tubular body (4) and suitable to house the said curvilinear end section of the tubular guide (19) .

9. Apparatus according to any of the preceding claims in which the said first tubular body (4) comprises a first ventilation channel (8) coaxial with the said first axis (5) .

10. Apparatus according to any of the preceding claims in which the said tracheoscope (2) comprises at least one insufflation line (15, 16) arranged along the said first tubular body (4) and an inflatable cuff (18) arranged along the periphery of the said first tubular body (4) and communicating with the said insufflation line (15, 16) .

11. Apparatus according to any of the preceding claims in which the said first tubular body (4) comprises at least a second channel (13) extending parallel to the said first axis (5) , and the said illumination devices (14) comprise at least one optical illumination fibre (14) inserted along the said second channel (13) .

12. Apparatus according to any of the preceding claims in which the said first tubular body (4) comprises at least a third channel (11) extending parallel to the said first axis (5) , and the said optical inspection devices (12) comprise an optical probe (12) that can be inserted, in such a way that it can be extracted, along the said third channel (11) .

13. Apparatus according to any of the preceding claims in which the said first tubular body (4) comprises at least a fourth aspiration and/or washing channel (17) extending parallel to the said first axis (5) .

14. Apparatus according to any of the preceding claims and moreover comprising control devices (3) suitable for connection to the said tracheoscope (2) , the said control devices (3) comprising at least one eyepiece (42) connectable to the said optical inspection devices (12) , a terminal (40) connectable to a light source (41) and to the said illumination devices (14) , and advance devices (38, 39) connectable to the said perforation and traction element (21) to make it slide along the said first tubular body (4) and advance it towards the said intra- annular space .

15. Apparatus according to Claims 14 and 4 in which the said advance devices (38, 39) are selectively connectable to the said tubular element (20) to make it advance towards the said intra-annular space sliding it along the said tubular guide (19) , or to the said perforation and traction element (21) to make it advance towards the said intra-annular space sliding it along the said tubular element (20) .

16. Apparatus according to Claims 14 or 15 in which the said control devices (3) moreover comprise a cutting device (49) activatable to execute a longitudinal cut parallel to the said first axis (5) along the said first tubular body (4) .

17. Apparatus according to Claim 16 in which the said control devices (3) comprise a gun (37) fitted with a second tubular body (43) extending along a respective second longitudinal axis (44) and having a housing (45) suitable to house a second end section (2a) of the said tracheoscope (2) .

18. Apparatus according to Claim 17 in which the said gun (37) comprises a detachable tubular cap (46) coupled to one end (43a) of the said second tubular body (43) , and in which the said cutting device (49) comprises a blade (50) securely connected to an activation button (51) , the said cutting device (49) being held in the said tubular cap (46) and being movable with respect to the tubular cap (46) from a rest position to an operating position where the said blade (50) cuts into the said first tubular body (4) .

19. Apparatus according to any of the preceding claims, moreover comprising a tracheostomy tube (25) fitted at one end with a penetration element (30) , and in which the said perforation and traction element (21) is connectable to the said tracheostomy tube (25) in such a way that following traction exercised on the free end of the perforation and traction element (25) , the said tracheostomy tube (25) is drawn inside the said trachea and made to exit progressively, through the said penetration element (30) , from the inside of the trachea to the outside through the said intra-annular space.

20. Apparatus according to Claim 19 in which the said tracheostomy tube (25) comprises a cannula (27) and a dilating cone/cannula (33) , the said dilating cone/cannula (33) defining the said penetration element (30) and being coupled to the said cannula (27) in such a way that it can be detached.

21. Apparatus according to Claims 17 and 19 in which the said housing (45) is suitable to house, during use, the said tracheostomy tube (25) .

22. Apparatus according to any of the preceding claims in which the said tracheoscope (2) comprises a ventilation tube (61) and attachment devices (68, 69) to connect the said ventilation tube (61) to the said first tubular body (4) in such a way that it can be released.

23. Apparatus according to Claim 22 in which the said first tubular body (4) has an external groove (67) extending parallel to the said first axis (5) , the said ventilation tube (61) being housed in such a way that it slides along the said external groove (67) .

24. Method for performing percutaneous tracheostomy comprising the phases of inserting a tracheoscope (2) into the patient until entering the trachea, the said tracheoscope (2) comprising a first tubular body (4) , illumination devices (14) and optical devices (12) , and being fitted with a perforation and traction element (21) arranged in such a way that it slides inside the said first tubular body (4) , the method comprising the additional phase of advancing the said perforation and traction element (21) along the said first tubular body

(4) to make it exit from one end of the said tracheoscope (2) in such a way as to perforate, from the inside to the outside, an intra-annular space of the trachea.

25. Method according to Claim 24 in which the said tracheoscope (2) comprises a tubular guide (19) fixed along the said first tubular body (4) and a tubular element (20) arranged in such a way that it slides along the said tubular guide (19) , the said perforation and traction element (21) mounted in such a way that it slides along the said tubular element (20) ; the method also comprises the phase of advancing the said tubular element (20) along the said tubular guide (19) to make it exit from the said end until it ultimately comes into contact with the said intra-annular space, and of advancing the said perforation and traction element (21) towards the said intra-annular space after advancing the said tubular element (20) .

26. Method according to Claim 25 in which before inserting the said tracheoscope (2) into the patient, and end portion (2a) of the tracheoscope (2) is connected to the control devices (3) suitable to selectively advance the said tubular element (20) or the said perforation and traction element (21) .

27. Method according to Claims 24 and 26 in which after executing the said perforation, the said tracheoscope (2) is extracted from the patient through the mouth and, during extraction, the said first tubular body (4) is cut longitudinally in a progressive manner.

28. Method according to Claim 27 in which during extraction of the said tracheoscope (2) and following cutting of the said first tubular body (4) , the said perforation and traction element (21) is progressively disengaged from the said tubular guide (19) and from the said tubular element (20) .

29. Method according the Claim 27 or 28 in which the said tracheoscope (2) comprises a ventilation tube (61) attached to the said first tubular body (4) in such a way that it can be removed, and in which the said ventilation tube (61) is detached from the said first tubular body (4) to be locked inside the trachea before extraction of the said first tubular body (4) .

30. Method according to Claims 24-29 in which the said perforation and traction element (21) comprises a needle

(22) and a traction wire (23) securely connected to each other, the said traction wire (23) being connectable to a tracheostomy tube (25) fitted with a penetration element (30) , the method comprising the phases of drawing the said perforation and traction element (21) from the outside and subjecting it to traction in such a way as to draw the said tracheostomy tube (25) into the said trachea, and of progressively extracting the said tracheostomy tube (25) by means of the said penetration element (30) from the inside to the outside through the said perforation.