Device for tracheotomy

The following invention relates to a device for tracheotomies, in particular for low-invasive or percutaneous tracheotomies. Low-invasive or mini-invasive tracheotomies have gained increasing interest in recent years and increasing space in intensive therapies, being today the most used techniques in the management of respiratory airways in patients who require medium to long- term ventilation, i.e. for periods that are longer than, for example, two weeks.

The techniques that are currently most used are percutaneous techniques by virtue of their simplicity, rapidity and applicability, even in critical conditions . Percutaneous tracheotomy involves making an incision of limited dimensions in the front wall of the trachea, dilating the incision by means of suitable dilating devices until it is possible to insert a cannula therein for ventilating the patient . Making the incision and introducing the cannula have to occur under continuous bronchoscopic control in order to permit a more correct performance of the operations and reduce the risk of possible complications, such as, for example, lesions to the mucous of the trachea. For this purpose, percutaneous tracheotomy is currently performed after inserting into the trachea of the patient an endotracheal tube through which a fibre-optic bronchoscope is inserted; the tube is extracted as much as possible to enable the incision of the trachea below the distal end of the endotracheal tube, and the bronchoscopic view of the tip of the introducer needle at the entry into the tracheal lumen and the subsequent technical steps .

The endotracheal tube used is normally provided with a standard inflatable sealing cuff for ensuring the seal during ventilation of the patient at positive pressure. The limit to this method lies in the long distance between the proximal part of the cuff and the tip of the tube, which

makes viewing difficult or impossible in patients with short necks and any way does not enable the rear wall of the trachea to be protected.

This last element is certainly very important inasmuch as the most frequent complications of percutaneous tracheotomy are characterised by lesions to the rear wall of the trachea. An object of the present invention is to provide a device that enables, during performance of a tracheotomy, appropriate ventilation of the patient, protection of the rear wall of the trachea, insertion of a fibre-optic bronchoscope and complete viewing of the front wall of the trachea, transillumination from the tracheal lumen, said device having reduced dimensions and being simple and quick to use. According to the present invention a device for tracheotomy is provided comprising:

- a flexible endotracheal tube that at a distal end thereof has an inflatable sealing cuff;

- inflating means of said sealing cuff associated with said endotracheal tube, said endotracheal tube extending beyond said cuff with an appendage consisting of a sector of cylindrical wall.

This appendage, which is introduced into the trachea by a standard laryngoscope technique, enables total exposure of the front wall of the trachea to be able to conduct transillumination and view with facility the entry of the needle into the tracheal lumen and simultaneously constitutes a protection against possible lesions to the rear wall of the trachea that can be caused by the instrument used to carry out the incision of the trachea, for example a needle instrument, or by other elements present in the various tracheotomy kits .

In a further embodiment of the present invention, said inflatable sealing cuff has an asymmetrical shape, said asymmetrical shape being selected in such a way that the cuff, after inflating, adapts to the shape of the laryngeal

aditus of a patient.

The asymmetrical shape of the cuff means that when it is inflated after the introduction of the endotracheal tube, immediately in front of the laryngeal aditus, it is in a supraglottal position enabling the necessary seal for ventilation, not occupying space inside the trachea, but ensuring the occlusion of the oesophagus.

According to a further aspect of the present invention there is provided a tracking system that is associable with said endotracheal tube, that enables the position in which to conduct the tracheotomy to be determined in a precise manner. The invention will now be disclosed merely by way of non- limitative example with reference to the attached drawings, in which: Figure 1 is a schematic view from above of a device according to the invention;

Figure 2 is a schematic side view of the device in Figure 1; Figures 3 and 4 show an enlarged detail of the device in Figures 1 and 2, to illustrate the sealing cuff respectively before and after inflating;

Figure 5 is a greatly enlarged detail of Figure 3, that illustrates the connection between the inflating tube obtained inside the wall of the endotracheal tube and the sealing cuff; Figure 6 illustrates the tracking device;

Figure 7 illustrates the endotracheal tube with the tracking device in position.

With reference to Figures 1 and 2, a device for tracheotomy according to the invention comprises an endotracheal tube 1 made, for example, of relatively stiff material, in which, at a certain distance from the proximal end thereof, an asymmetrical inflatable sealing cuff C is provided, the function of which is to ensure the seal of the tube in front of the laryngeal aditus AL (Figure 7), i.e. above the glottis G, and to occlude the oesophagus ES after the distal

end of the tube 1 has been introduced into the trachea of the patient.

The portion of tube after the cuff C consists of a short tubular length 2a followed by an appendage 2b having the shape of a portion of cylindrical wall, for example with an angular extent of approximately 180°, intended to be introduced into the trachea. The appendage 2b is preferably made from a softer and more flexible material than the material from which the endotracheal tube 1 is made, i.e. in order to limit the risks of lesions to the trachea of the patient during insertion into the trachea. The radius of curvature of the appendage 2b is substantially the same as the radius of the tubular portion 2a. The cuff C is associated with an inflating line that comprises a conduit D obtained in the side wall 6 of the tube 1 (Figures 3-5) that ends at 7 at the lower fitting 10 of the inflatable sealing cuff C, and with an external inflating line E, as in the normal endotracheal tubes. The fact that a part of the inflating line of the cuff is obtained in the thickness of the wall 6 of the tube 1 minimises the lateral dimensions of the tube. The external inflating line E consists of a flexible inflating line 5 provided, in the proximal portion, with a monitoring ball 11 for controlling the pressure inside the inflatable sealing cuff C and with a standard fitting S for connecting to any inflating device (syringe or other) .

Once this connection has been made it is possible to inflate the inflatable sealing cuff C, that is actuatable owing to the presence of an opening 8 through the side wall of the tube that permits the flow of air F from the inflating conduit D, obtained inside the wall 6, to the sealing cuff C. This cuff C consists of a sleeve of elastic material, applied coaxially above the side wall 6 of the tube 1 and fixed thereto at the two ends 9 and 10 thereof so as to ensure the air seal. The cuff C is furthermore asymmetrical so that, inflating, it takes on a shape substantially

corresponding to the shape of the laryngeal aditus so as to ensure the seal during ventilation and to occlude the oesophagus of the patient by exerting a pressure that is as reduced as possible on the mucous of the patient, so as to minimise the risks of lesions from compression on the mucous .

After inflating the cuff C, the device connects to a system for ventilating the patient through a fitting 4 or a catheter mount. This fitting comprises a first portion 4a, of cylindrical shape, intended to be connected to the above ventilation device, and a second portion 4b, this also with a cylindrical shape, intended to be inserted into the proximal end of the endotracheal tube 1. The external diameter of the second portion 4b of the fitting 4 element is chosen in such a way that the coupling between said second portion 4b and the internal wall of the endotracheal tube 1 occurs with interference to ensure the seal when the ventilation device blows in air; in other words, the external diameter of the second portion 4b of the fitting 4 element is chosen slightly greater than the internal diameter of the endotracheal tube 1.

The endotracheal tube 1 can be provided with a standard catheter mount with sealing cap to be connected to the ventilation fitting and with a fixing device for fixing to the head of the patient to prevent movement of the endotracheal tube when it has been inserted into the patient .

The endotracheal tube 1 can be provided on the external side surface thereof with position indicators and be provided with a radio-opaque line along the entire length thereof or in some parts thereof, or with other means that is useful for correct viewing and evaluation of the positioning of the device through radiographic means . The endotracheal tube 1 can be made, in a preferred embodiment, completely of soft and/or flexible material.

The device according to the invention furthermore comprises

tracking means P intended to facilitate identification of the point of the throat of the patient in which to conduct the tracheotomy and keep in position the instrument with which initial perforation of the wall of the trachea is conducted, when conducting a tracheotomy.

Once the endotracheal tube 1 has been positioned, the cuff C has been inflated and the patient has been ventilated, the tracking means P is connected to the endotracheal tube 1, as illustrated in Figure 6. The tracking means P comprises a telescopic rod 12, preferably metal, with fixing screw 13, that locks the telescopic movement of the rod 12, to prevent any variation in length when an appropriate length of the rod 12 has been fixed, on the basis of the physical features of the patient. The telescopic rod 12 is fixable to the proximal end of the endotracheal tube 1, immediately below the fitting element 4 with the ventilation system, by means of a ring 14 that can be tightened with a screw mechanism 14a on the external wall of the endotracheal tube 1. The telescopic rod 12 is connected to the ring 14 by means of an articulated connecting element 15 with locking screw 15a. The articulated connecting element 15 enables said first end of the rod 12 to be positioned angularly with respect to the ring 14 and said first end to be locked in the chosen angular position by means of the locking screw 15a. At a second end, opposite said first end, the telescopic rod 12 is connected to a second ring 16a by means of a further articulated connecting element 20 with locking screw 21. This ring 16a can be tightened with a screw mechanism 16b on the wall of a positioning system 16, consisting of housing for a metal cannula 17 that acts as a guide for a surgical instrument intended for making an incision in the trachea of the patient . The sliding of the further ring 16a is used to position the cannula 17 at the point of incision 18 of the trachea (Figure 7) in which the tracheotomy has to be performed. The

articulated element 20 permits angular positioning of the cannula 17, so that it is in the optimal position and at the point of the throat of the patient where the incision has to be made for the tracheotomy. The cannula 17 furthermore has a screw connection 19 for connecting a source of external lighting, for example a source of fibre-optic lighting. The procedure for using the tracker P is as follows: once the tube 1 is positioned with the inflatable sealing cuff C inflated and in position and the distal end 2b of the endotracheal tube 1 inserted into the trachea of the patient, through the catheter mount a bronchoscope is inserted into the endotracheal tube 1. The transillumination from the inside of the trachea, achievable through the bronchoscope, enables the point to be identified (seeing the light from the exterior) where the incision has to be made. When this has been done, the tracker P is fixed, adjusting the length of the telescopic rod 12, the angular position of the articulated connecting elements 15 and 20 and the position of the further ring 16 on the pin 16a. Once the tracker P has been fixed, the luminous intensity of the light source of the bronchoscope is lowered and the source of external illumination is inserted into the metal cannula 17, connecting it to the appropriate fitting 19. Transillumination from the exterior is then conducted. In fact with the bronchoscope, from the interior it will be possible to see the light and check, - thus from the interior of the trachea - whether the tracker P is positioned in the correct manner. It is thus possible to modify the position of the tracker P if necessary and possibly fix it with appropriate screws or other fixing systems so that the chosen position remains unvaried during performance of the tracheotomy.

Once the tracker P has been fixed, the source of external lighting is removed and through the tracking cannula 17, the tracheotomy is performed using normal tracheotomy techniques.

In the practical embodiment, the materials, the dimensions and the constructional details may be different from those indicated but be technically equivalent thereto, without thereby falling outside the scope of the present invention.