WO2011004417A1

WO2011004417A1 - Orotracheal tube

Info

Publication number: WO2011004417A1
Application number: PCT/IT2010/000303
Authority: WO
Inventors: Tito Mario Franco Passannanti; Francesco Diurno
Original assignee: Individual
Current assignee: Individual
Priority date: 2009-07-09
Filing date: 2010-07-07
Publication date: 2011-01-13
Anticipated expiration: 2012-01-09
Also published as: ITNA20090022U1

Abstract

The invention relates to an oro-tracheal tube, usable for lung separation in mechanical ventilation, provided with two respiratory paths or independent lumens (T, B), characterized in that said tube is provided with a distal end (ED) having a substantially rectilinear conformation, that is to say which substantially extends along the longitudinal axis of the tube (1), on said end (ED) acting means apt to determine, on command, a temporary curvature of the said end, being sensor means foreseen (S) for the positioning of the said tube (1) capable of determining the position of the tube with respect to the respiratory tree in which the tube is inserted.

Description

TITLE: OROTRACHEAL TUBE

DESCRIPTION

The present invention relates to an orotracheal tube.

It is well-known that lung separation in mechanical ventilation is usually defined as one-lung ventilation (OLV) in surgery and, in intensive care, as real separate-lung ventilation.

Among the indications in surgical activities we can find: lung, lobar, segmental, cuneiform resections, video assisted surgery, bronchial and tracheal pathologies due to traumatic ruptures, bronchopleurical fistulae, some operations for esophageal pathologies.

Among the indications in intensive care we can find phlogistic or traumatic pathologies affecting one lung.

In the past, single lumen bronchial blockers and endobronchial tubes were used, but these systems have been abandoned due to technical difficulties and to their incapability of removing secretions from the lung on the blocked side.

At present, lung separation foresees the use of suitable dedicated bilumen tubes for oro-tracheal bronchial intubation. The commonest tubes are the Carlens and White tubes and the

Robertshaw tubes which will be described in the following..

The Carlens and White tubes (an embodiment of which is shown in Fig. 2) are used, respectively, for selective bronchial left and right intubation. Said tubes are provided with a tracheal lumen or channel, indicated by reference T in the drawings and by a bronchial lumen or channel, indicated by reference B. The two lumens T and B of the tube have different lengths: the tracheal lumen T has a length which is shorter than the length of the bronchial tube

B; the two lumens extend up to their respective distal ends defined by corresponding openings

Ft and Fb. The tubes are provided with a carinal rostrum R and, during the phase of association to the patient, they foresee an intra-tracheal rotation after going beyond the vocal cords. Both tubes are to be inserted with a rostrum for their anchoring to the carina in correspondence of the rear part of the laryngeal entrance. In this position, the tube is pushed between the vocal cords and, at the same time, it is rotated by 180° in the counter-clockwise direction. Said rotation bends the rostrum R and compresses it against the wall of the tube, so as to avoid the latter to engage in a vocal cord and to damage said vocal cord. Once the tube has gone beyond the vocal cords, it is rotated again by 90° in the clockwise direction if the tube is a Carlens tube or in the counter-clockwise direction if the tube is a White tube and pushed further into the trachea so as to allow the rostrum to lie on the tracheal carina. In this way, the bronchial portion of the tube will be positioned in the left bronchus if the tube is a Carlens tube and in the right bronchus if the tube is a White tube. The correct position is to be checked after the two caps, with which the tube is provided, have been inflated (indicated in Fig.2 with references Ct- tracheal cap and Cb - bronchial cap), by alternatively hyperventilating one of the lungs, after exclusion of the contralateral lung. No respiratory noises should be present in the excluded lung during auscultation.

The Robertshaw tubes are of two types and they are, respectively used for left and right selective bronchial intubation. Also these tubes are bilumen tubes, they are similar to the previous tubes but they are not provided with a rostrum, they are provided with a premoulded bronchial portion (which, also in this case, is positioned distally). Since the tubes are not provided with a rostrum, their correct positioning does not foresee the first rotation of 180° but only the tracheal rotation so as to allow the bronchial portion of the tube to coincide respectively with the left or the right bronchus, depending on the type of tube being used. At present, said tubes are the most commonly used tubes, since their use implies a lower risk of damage to the vocal cords and to the carina. Most anaesthetists prefer a selective intubation of the left bronchus, also for the exclusion of the left lung, to avoid both an easier occlusion of the right upper bronchus (which is only 2,5 cm far from the carina) and a concentric inflation in the bronchus for the left tube, being the right cap asymmetrical; in fact, the distal cap embraces in a horseshoe manner the hole relative to the right upper lobe bronchus, therefore said cap is narrower in its lateral portion than in its medial portion. It is obligatory to use the right tube in anatomic variations of the left main bronchus (extrinsic compression, aortic arch aneurysm).

The correct positioning of a Robertshaw tube is to be verified through a series of manoeuvres which foresee isolated expansion of the lungs without excluding parts thereof; however, a direct-vision verification through the use of a bronchoscope is advisable.

Once the Robertshaw tube has been positioned, it is necessary to carry out a verification both with the tracheal cap and with the bronchial cap, due to the frequency at which incorrect positioning may take place.

The verification foresees the following operations:

- the tracheal cap is inflated and, through auscultation, the symmetricity of the murmur on both lung fields is verified; if a hemitorax is not ventilated well, the cause may be an excessive insertion of the tube. In this case, the tracheal hole may rest on the carina with a partial occlusion of said hole, or the tracheal hole may be completely blocked up if, after the complete descent of a bronchus, the contralateral bronchus is completely excluded.

-The bronchial cap is subsequently inflated with con 2-3 ml air and the symmetricity of the murmur is verified again through auscultation; if the bronchial cap is too full, it may herniate downward with occlusion of the bronchial hole of the tube and the consequent absence or reduction of the murmur in the dependent lung, or it may herniate upwards and migrate beyond the carina with a partial or total occlusion of the entrance of the contralateral bronchus.

- Verify if the bronchial prolongment is positioned in the chosen main bronchus. For the left bronchial intubation, clamp the tracheal lumen and observe the thoracic expansion and the presence of vescicular murmur on the left only; an analogous symmetrical manoeuvre is necessary for the one on the right. Then clamp the left bronchial lumen and observe the thoracic expansion and the presence of vescicular murmur on the right. It is necessary to carry out an analogous symmetrical proof if a right tube is used.

The risk of occlusion of the left upper lobe bronchus, if the left Robertshaw tube is pushed too deeply, should always be considered; if this happens, the left lung will be ventilated in a dishomogeneous way whereas the right lung will be excluded. When a right Robershaw tube is used, the risk of occlusion of the right upper lobe bronchus is elevated since it is at a distance of about 2 cm from the carina. The excessive insertion of a right Robertshaw tube causes the exclusion of the left lung and of the right upper lobe.

Besides anomalies of position relative to the insertion depth of the tube into the trachea and into the bronchi, anomalies in the rotation of the tube may be present with numerous anomalous respiratory cases relative to the partial or total occlusion of the tracheal hole and of the right upper bronchial hole.

Besides visual and auscultatory controls, as previously pointed out, it is always advisable to carry out a bronchoscopic control after the positioning of a bilumen tube. In fact, it has been demonstrated that perfectly positioned double lumen tubes with an adequate inspective and auscultatory control, after a fibroscopic control, show an incidence of incorrect positioning of 20-48%.

As described above, the orotracheal intubation technique with bilumen tubes is rather complex and frequently characterized by anomalous positioning of the devices of the respiratory apparatus; in fact, it is necessary to carry out additional direct-vision instrumental investigations to be absolutely certain of a perfect positioning. Moreover, the tubes currently used for lung separation with a right or left premoulded rigid distal end exhibit, in their passage through the first respiratory path, a caliber on the horizontal plane which is much greater than the useful caliber of the two lumens. The distal angulature, in fact, deviates from the axis of the tube and increases the horizontal diameter of the same tube.

The difficulty in carrying out a correct positioning with respect to the main bronchi arises from the incapability of observing the progression of the tube into the respiratory apparatus with direct vision. Only through bronchoscopy with an already positioned tube, a technique which can be carried out by extremely experienced staff, it is possible to get the certainty of a perfect positioning.

One of the aims of the present invention is to reduce technical difficulties in the intubation manoeuvre, with a simplified positioning of the tube in the exact position; another aim of the present invention is to make the passage of premoulded rigid tubes less harmful to the tissues of the respiratory tree.

These results and other results have been achieved, according to the present invention, by adopting the idea of an orotracheal tube having the features described in claim 1. Further features are the subject of the dependent claims

Among the advantages of the present invention are those described in the following.

Advantageously, the tube of the present invention is provided with a straight distal end (Fig. 1, reference Pd), in line with the axis of the tube, an end which can be angulated after its passage through the larynx and the trachea so that it can be oriented towards the selected bronchus. Moreover, the tube is provided with a number of proximity sensors (Fig. 1, reference S), capable of transmitting the signal outwards in order to indicate the position of the tube with respect to the main bronchi and with respect to the upper lobe bronchi; the tube can be provided with optical fibres with reading zones in correspondence of the tracheal and bronchial ventilation holes, so as to allow vision from the exterior (Fig. 10, references F.O.T. e F.O.B.). Thanks to the present invention, it is possible to obtain a remarkable reduction of the difficulties connected with the intubation manoeuvre, with an easy monitoring of the positioning conditions of the tube. Besides, the passage of the tube is noticeably less harmful to the tissues with which the tube comes into contact.

Every technician who works in this field will better understand these advantages and features and further advantages and features of the present invention thanks to the enclosed drawings as a practical explanation of the present invention which should not be considered in a limitative sense, wherein

- 1 Fig. 1 is a schematic perspective view of a possible embodiment of an oro-tracheal tube according to the invention; in the figure, the tube is shown subdivided into two portions, to indicate that its length is greater than the length shown in the figure ;

- Fig. 2 schematically shows a well-known type of tube;

- Figs. 3a and 3b schematically show a specific left tube realized according to the invention, respectively shown in a sagittal or plan view (Fig.3a) and a lateral view (Fig. 3b);

- Figs. 4a, 4b e 4c schematically show a right specific tube realized according to the invention, respectively shown in a sagittal or plan view (Fig.4a), in a right lateral view (Fig. 4b), and in a left lateral view (Fig.4c);

- Figs. 5a and 5b schematically show a tube which is usable both on the right and on the left, realized according to the invention, and respectively shown in a sagittal or plan view (Fig.5a) and in a lateral view (Fig. 5b);

- Fig. 6 is a schematic perspective view of a detail in an enlarged scale, relative to a tie rod for the curvature of the distal end ;

- Figs. 7a and 7b schematically show the embodiment of a left specific tube shown in Figs. 3a and 3b, respectively shown in a sagittal or plan view (Fig.7a) and in a lateral view (Fig. 7b), provided with proximity sensors;

- Figs. 8a, 8b and 8c schematically show the embodiment of a right specific tube shown in Figs. 4a, 4b and 4c, respectively shown in a sagittal or plan view (Fig.8a), in a right lateral view (Fig. 8b), and a left lateral view (Fig.8c), provided with proximity sensors;

- Figs. 9a, 9b and 9c schematically show the embodiment of a specific tube usable both on the right and on the left shown in Figs. 5a and 5b, respectively shown in a sagittal or plan view

(Fig.9a), in a right lateral view (Fig.9b), and in a left lateral view (Fig.9c), provided with proximity sensors;

- Figgs 10a, and 10b schematically show the embodiment of a right specific tube shown in Figs. 4a, 4b and 4c, respectively shown, in a right lateral view (Fig. 10a) and in a left lateral view (Fig.10b), provided with optical-fiber- sensors; in the embodiment of Fig.10a the distal end is shown without the bronchial cap Cb shown in Fig. 4b.

According to the present invention, differentiated tubes are foreseen for right and left bronchial intubation due to a different anatomical conformation of the upper lobe bronchi which are detached on the right from the carina of a about 2 cm and on the left of about 4 cm. Therefore, the bronchial holding cap Cb is differently conformed. For the right one a ventilation hole Fb should be present for the upper lobe bronchus (see Fig. 4), just at the level of the cap Cb. Advantageously, thanks to the presence of sensors or optical fibers through which it is possible to verify the exact position of the distal portion with respect to the ostium of the upper lobe bronchi, it is possible to foresee a single ambivalent right-left tube provided with two bronchial caps CbI and Cb2 (see Figs.5a and 5b), besides the tracheal cap Cf, which is the same for all types of tubes. The two bronchial caps Cl and Cb2 are disposed respectively upstream and downstream of the origin of the upper lobe bronchus.

Therefore, according to the present invention, it is possible to realize three types of bilumen tubes: - specific left tube;

- specific right tube ; and

- single tube for the left and for the right provided with 2 distal caps.

The tubes realized according to the invention (indicated with 1 in their totality) are formed by a bilumen tracheal portion and by a mono-lumen tracheal portion. The bilumen portion (whose length is indicated with LT in Fig. 3b) ends exactly at the level of the tracheal bifurcation in the two main bronchi and the tracheal lumen Ft ends with a hole which is exactly in correspondence of the non- intubated main bronchus. From this point onwards, if we proceed distally into the mono-lumen portion (whose length is indicated with LB in Fig. 3b), the shape of the three tubes varies according to the destination of its use, if it is a left destination, a right destination or a single destination.

In the case of the left tube, the length of the mono-lumen component from the tracheal hole is about 4 cm; the structure should be extremely flexible and non compressible in case of stress during flexion, preferably provided with a solenoid-shaped metal armature A. In the case of the left tube, moreover, most of the mono-lumen component is externally occupied by the bronchial holding cap, which is inflatable from the exterior.

In the case of the right tube, the length of the mono-lumen component from the tracheal hole, relative to the ventilation of the left lung, is about 4 cm; for the above reasons, the structure should be armed (armature A). The bronchial cap Cb occupies most of the length of the mono- lumen component, but with a different shape with respect to the left one. In fact, it is asymmetrical because laterally on the right (seen in a front-rear view), with the tube in position, it exhibits a hole FbI which connects the internal lumen with the external environment. Therefore, the internal lumen ends with a hole Fb2, on which the ventilation of the lower medium lobe depends and laterally, on the right, with the hole FbI which, being disposed in correspondence of a free zone of the holding cap, guarantees ventilation to the right upper lobe.

In the case of the single tube for right or left intubation, the length of the mono-lumen component is about 4 cm. The structure, which is armed, too (armature A), does not exhibit a single cap in the exterior like in the previous examples, but two short holding caps CbI and Cb2, with a longitudinal development along the tube which is inferior to the caps of the previous examples. The caps are disposed one CbI in proximal position (in correspondence of the origin of the left or right bronchus), the other Cb2 is disposed in a distal position. The proximal cap CbI has the aim of holding pressure, the distal cap Cb2, increases the contact surface tube-bronchus and aims above all at reaching stability, avoiding its dislocation and facilitating a better centering of the tube in the bronchus. The presence of a ventilation hole FbI₅ relative to the upper right lobe bronchus is foreseen between the two caps. If used in the left position (after a rotation on the horizontal plane of 180° with respect to the right intubation), the lateral hole will not be used, and the air flux will exit from the distal hole only. The three examples, although they have substantial differences, especially in the holding caps, have one aspect in common: they can be bent in correspondence of the distal end (ES). Said flection can bring them from the rectilinear conformation, corresponding to the axis of the tube, to a curved conformation (with a curvature opposite to the tracheal hole), so as to define, with respect to the axis of the tube, a maximum angle of about 45°. As shown in the non-limitative embodiments, said flexion can be carried out manually, by operating a command Ftr external to the tube (shown in the Figs 1 and 6). In fact, in the lateral portion of the tube opposite to the portion where the tracheal hole Ft is present, over the whole length of the tube, it is foreseen the presence of a thread Ftr provided with a holding ring An. The thread Ftr is fixed to a point D in correspondence of the distal end of the tube and slides in a dedicated conduit provided by the body of the tube so that it can exit in the proximal portion of the tube. Being said thread firmly anchored only in the distal point of origin D and being it capable of sliding along the body of the tube, its traction (see arrow V) from the exterior, causes the flexion of the point (see rotation R). Only the tip can be bent, since the body of the tube, in the whole bilumen portion, will be strengthened both by the bilumen component, which is stronger, and by a spindle which will be used during positioning and extracted after the tracheal positioning. The flexion manoeuvre of the point should last few seconds and should be carried out only when it is necessary to direct the point towards the selected main bronchus. It is possible to foresee a locking device, for example a lever, to keep the thread in tension during the sliding of the tube along the trachea and to avoid manual traction (said locking device is not shown in the drawings, being it realizable in various ways). Once the tube has been inserted into the bronchial component of one of the two bronchi, the command thread Ftr can be released and the progression of the oro-tracheobronchial tube will be governed by proximity sensors or by the processing of the images obtained from the optical fibers.

As previously said, it is foreseen the presence of sensors S capable of verifying, during the progression phase of the tube into the respiratory path, the relationship of the tube itself with the main bronchi and the upper lobe bronchi. Through the use of sensors, it is also possible to verify at any time the exact position of the device. The sensors, positioned along the body and the point of the tube, are capable of perceiving the distance between the tube and the tracheal or bronchial wall. The sensors S can function by means of ultrasonic emissions or in the infrared field or another suitable signal and are capable, with predetermined tolerance, to identify the presence of solid tissue or the presence of void relative to the origin of the bronchi. The immediate return of the signal identifies the passage of the sensor through the full tissue, whereas a slowed down return, until the complete disappearance of the signal return, identifies the passage of the sensor through an empty branch . The verification of said signals will be external, by means of luminous spy lamps and/or visualizers L disposed on the proximal part of the tube. The position of the sensors will be different depending on the chosen tube, as described in the following.

In the case of the left tube (see Figs.7a-b), it is necessary to consider that, as previously said, the right upper lobe bronchus detaches at about 4 cm from the carina and allows therefore a good positioning of the bronchial component, without any relevant interferences with the upper lobe bronchus. To avoid any interference with the left upper lobe bronchus, although said interference is not likely to occur, it is possible to dispose a left, lateral apical sensor S3. For this type of tube it is therefore foreseen the use of three sensors, positioned:

- one S2, disposed distally to the tracheal hole;

- one Sl, disposed proximally to the tracheal hole;

- one S3 in a bronchial apical position, which recognizes a possible left upper lobe bronchus. The right ventilation depends on the first two sensors Sl and S2: an incorrect position of the hole, in fact, can seriously hinder the right ventilation. If we consider the sensors Sl and S2 for the right bronchial hole, during the insertion phase of the tube, the first distal sensor S2, in its passage through the right main bronchus, will recognize the absence of signal return; the signal return will reappear as soon as the sensor comes in contact with the medial wall of the left main bronchus . The correct position of the tube is perceived by the signal return of both tracheal sensors, the distal sensor S2, which is now positioned in the left bronchus and the proximal sensor Sl positioned in the trachea before the division in the two main bronchi.

In the case of the right tube (see Fig.8a-c) it is foreseen the presence of four sensors, two distal sensors (bronchial) S3, S4 and two proximal sensors Sl, S2. The proximal sensors Sl and S2 are analogous to those described for the left intubation. The distal sensors S3 and S4 will be positioned at the two ends of the ventilation hole of the right upper lobe bronchus FbI and will recognize, in their definitive position, the absence of void relative to said bronchus.

In the case of the single tube (see Figs.9a-c), it is foreseen the use of two holding cups in the bronchial part of the tube, a proximal cap CbI, which is annular and symmetrical and positioned before (proximally to) the lobe hole, and a distal cap Cb2, positioned beyond the hole (distally), capable of providing greater stabilization for the tube. For said tube, it is foreseen the presence of four sensors, two distal sensors (bronchial) S3 and S4 and two proximal sensors Sl and S2. The proximal sensors Sl and S2 correspond to those described for the right intubation. The two distal sensors S3 and S4, are positioned close to the two holding caps (distally to the proximal cap and proximally to the distal cap) and are of greater utility for the use of the tube on the right; in, fact, in their definitive position, they will recognize the absence of void relative to the right upper lobe bronchus. In the left intubation

(rotation by 180° on a horizontal plane), the two distal sensors S3 and S4, if the intubation is executed correctly towards the left main bronchus, there should never be a void signal.

Thanks to the use of optical fiber technology in the matrix, that is to say in the body of the tube, it is foreseen the presence of bundles of optical fibers which start from the zones of the tube corresponding to the tracheal hole F.O.T. and to the bronchial hole F.O.B., and end in the extra-oral portion, with their corresponding devices CCD: a tracheal device CCD-T and a bronchial device CCD-B (see Figg.lθa-b). It is also possible to foresee a connection to an external monitor for a more detailed vision, after an adequate processing of the images. The optical fibers originate from the tracheo-bronchial, distal portion of the tube, in the regions corresponding to the two ventilation holes (tracheal hole and bronchial hole). They completely wrap up the perimeter of the ventilation holes and, gathered in bundles, they proceed into the matrix of the tube and are taken to the CCD in the extraoral proximal portion of the tube. The corresponding CCD, by means of a image processor, show the sliding surface of the tube along the respiratory tree and identify, in millimetric measurement, the origin of the main bronchi. The corresponding CCD can be mobile, hinged at one point only for a better visualization of the images.

The correct intubation manoeuvre is to be executed by using the proposed oro-tracheo bronchial tubes, in more phases, as described in the following.

Through the usual employment of a laryngoscope, like in a normal oro-tracheal intubation, the laryngeal entrance is put into view; once the bilumen tube, which has been armed with the rigid spindle, is positioned in the bronchial lumen, the bilumen tube is inserted between the vocal cords, like in a normal intubation with a mono-lumen tube. After going beyond the vocal cords, so that the hole for the bronchial ventilation is positioned in the trachea and the two external lumens are kept external to the oral cavity (indicated with T and B in Fig.1) in a perfect horizontal position, it is possible to remove the stiffening spindle.

The progression of the tube into the trachea is to take place after the traction of the orientation thread Ftr of the bronchial portion, or after activation of the locking device for the tension of the thread. The thread Ftr is obviously to be positioned on the left for the left bronchial intubation and on the right for the right bronchial intubation. Once the sensors have been activated, the progression of the tube into the trachea and into the bronchi is to be executed with a control of the passage of the latter through the various possible bronchial branches. Since it is foreseen the use of optical-fiber technology, a light generator will be activated. The control of the correct insertion of the tube into the trachea and into the chosen bronchus is to be executed when the caps are deflated. Said caps will be inflated, like in every intubation, when the tube is in a definitive position . The filling of the caps with air, in fact, when the sensor or the optical fibers are moved away from the tracheal wall, could give a false signal of the presence of a bronchus or remarkably reduce the luminous resolution sensitivity; the presence of perfectly adjusted sensors on the exact distance of the sensor from the mucosa, connected with a correct capping system can verify, besides the presence of the void space relative a bronchial ostium, also the excessive or insufficient pressure present in the caps .

In practice, the construction details may vary in any equivalent way as regards the shape, dimensions, disposition of elements, nature of the used material, without nevertheless departing from the scope of the adopted solution idea and thereby remaining within the limits of the protection granted to the present patent.

Claims

1. Oro-tracheal tube, usable for lung separation in mechanical ventilation, provided with two respiratory paths or independent lumens (T, B), characterized in that said tube is provided with a distal end (ED) having a substantially rectilinear conformation, that is to say which substantially extends along the longitudinal axis of the tube (1), on said end (ED) acting means apt to determine, on command, a temporary curvature of the said end, being sensor means foreseen (S) for the positioning of the said tube (1) capable of determining the position of the tube with respect to the respiratory tree in which the tube is inserted.

2. Oro-tracheal tube according to claim 1, characterized in that said distal end (ED) is provided with a stiffening armature (A)

3. Oro-tracheal tube, according to claim 1, characterized in that said tube is provided with a thread (Ftr) whose distal end (D) is anchored to the distal end (ED) of the tube, being said thread (Ftr) positioned passing in a corresponding channel (C) disposed along the longitudinal development of the tube (1), so as to determine, in correspondence of a traction

(V) exerted on the thread, a corresponding curvature (R) of said distal end (ED).

4 . Oro-tracheal tube according to claim 3, characterized in that said thread (Ftr) can be fixed in a traction configuration.

5. Oro-tracheal tube according to claim 1, characterized in that said sensors (S) are connected to luminous spy-lamps and/or visualizers (L) positioned in the proximal portion of the said tube (1).

6. Oro-tracheal tube according to claim 1, characterized in that said sensors (S) are proximity sensors and identify the respiratory paths by recognizing a void zone, that is to say according to a slowed down or absent return signal.

7 . Oro-tracheal tube according to claim 1, characterized in that said sensors (S) are disposed along the body of the oro-tracheal tube, upstream and downstream of the hole relative to the ventilation of the non-intubated main bronchus.

8 . Oro-tracheal tube according to claim 1, characterized in that the two sensors (S) are disposed upstream and downstream of the hole relative to the right upper lobe ventilation, so as to allow the positioning of said tube in correspondence of the ostium of the right upper lobe bronchus.

9. Oro-tracheal tube according to claim 1, which is usable, in particular, for the left intubation, comprising a tracheal opening or tracheal hole (Ft) and a bronchial opening or bronchial hole (Fb) disposed distally to the tube (1), characterized in that the tube is provided with three sensors: a first sensor (S2) disposed distally to the tracheal hole (Ft), a second sensor (Sl), disposed proximally to the tracheal hole and a third sensor (S3) in a bronchial apical position, that is to say in correspondence of said bronchial hole. (Fb).

10. Oro-tracheal tube according to claim 1, usable, in particular, for the right intubation, comprising a tracheal opening or tracheal hole (Ft), a bronchial opening or bronchial hole (Fb2) disposed distally to the tube (1) and an opening or hole (FbI) disposed on the lateral surface of the tube (1), characterized in that the tube is provided with four sensors: two distal or bronchial sensors (S3, S4) and two proximal sensors (Sl, S2); being the proximal sensors respectively disposed upstream and downstream of the tracheal ventilation hole (Ft), and being the distal holes (S3, S4) respectively disposed upstream and downstream of the ventilation hole of the lobe bronchus (FbI).

11. Oro-tracheal tube according to claim 1, usable in particular both for the left and right intubation, comprising a tracheal opening or tracheal hole (Ft), a bronchial opening or bronchial hole (Fb2) disposed distally to the tube (1) and an opening or tube (FbI) disposed on the lateral surface of the tube (1), characterized in that the tube is provided with four sensors: two distal or bronchial sensors (S3, S4) and two proximal sensors (Sl, S2); being the proximal sensors disposed respectively upstream and downstream of the tracheal ventilation hole (Ft) and being the distal holes (S3, S4) respectively disposed upstream and downstream of the ventilation hole of the lobe bronchus. (FbI).

12. Oro-tracheal tube according to claim 1 and/or 12, characterized in that said tube is provided with at least one tracheal cap (Ct) and with a bronchial cap (Cb).

13. Orotracheal tube according to claim 12, usable in particular for the left intubation, comprising a tracheal opening or tracheal hole (Ft) and a bronchial opening or bronchial hole (Fb) disposed distally to the tube(l), characterized in that the brachial cap (Cb) is disposed in correspondence of the distal end (ED) of the tube upstream of said bronchial hole (Fb).

14. Oro-tracheal tube according to claim 12, usable in particular for the right intubation, comprising a tracheal opening or tracheal hole (Ft), a bronchial opening or bronchial hole (Fb2) disposed distally to the tube (1) and an opening or hole (FbI) disposed on the lateral surface of the tube (1), characterized in that the bronchial cap (Cb) is disposed in correspondence of the distal end (ED) of the tube and asymmetrical so as to leave a free zone in correspondence of said hole (FbI).

15. Oro-tracheal tube according to claim 12, usable in particular both for the right and for the left intubation, comprising a tracheal opening or tracheal hole (Ft), a bronchial opening or bronchial hole (Fb2) disposed distally to the tube (1) and an opening or a hole (FbI) disposed on the lateral surface of the tube (1), characterized in that the tube (1) is provided with two holding caps (CbI, Cb2), respectively disposed upstream and downstream of said bronchial hole (FbI) which is disposed laterally.

16 . Oro-tracheal tube according to claim 1, characterized in that said sensors (S) comprise readers connected by means of optical fibers to corresponding devices CCD disposed or connected to the proximal portion of the tube, that is to say the external portion.

17 . Oro-tracheal tube according to claim 1, characterized in that said sensors (S) comprise readers connected by means of optical fibers to corresponding devices CCD disposed or connected to the proximal portion of the tube, that is to say the external portion .

18 . Oro-tracheal tube according to claim 1 characterized in that the tube (1) is provided with optical fibers whose distal end surrounds the perimeter of a tracheal ventilation hole.

19. Oro-tracheal tube according to claim 1 characterized in that said tube (1) is provided with optical fibers whose distal end surrounds the perimeter of a bronchial ventilation hole .

20. Oro-tracheal tube according to one or more claims from claim 16 to claim 19, characterized in that the optical fibers are connected to external visualization means.

21. Oro-tracheal tube according to one or more claims from claim 16 to claim 19, characterized in that the optical fibers are connected to external visualization means.

22. Oro-tracheal tube according to one or more of the previous claims, characterized in that said means apt to determine the curvature hallow a shape variation on the horizontal plane when the tube is inserted in trachea, i.e. with the patient in the position of the insertion procedure.