Technical Field

-The present invention concerns a system and a method to execute a tracheal intubation.

Background of the invention

-Tracheal intubation is the placement of a flexible plastic tube into the trachea to protect the patient's airway and provide a means of mechanical ventilation.

-The most common tracheal intubation is the oro-tracheal intubation where, with the assistance of a laryngoscope, an endotracheal tube is passed through the mouth, larynx, and vocal cords, into the trachea.

-A bulb is then inflated near the distal tip of the tube to help secure it in place and protect the airway from blood, vomit, and secretions.

-Another possibility is nasotracheal intubation where a tube is passed through the nose, larynx, vocal cords, and trachea.

-Tracheal intubation is a potentially very dangerous invasive procedure that requires a great deal of clinical experience to master.

-When performed improperly (e.g., unrecognized esophageal intubation), the associated complications may rapidly lead to the patient's death.

-No single method for confirming tube placement has been shown to be 100% reliable.

-There are various types of tracheal tubes for oral or nasal intubation.

-Tubes may be flexible or pre-formed and relatively stiff.

-They are usually made of flexible plastic or silicone, though they may be armored with metallic rings to prevent kinking.

-Tracheal intubation can be performed by direct laryngoscopy (conventional technique), in which a laryngoscope is used to obtain a view of the glottis.

-A tube is then inserted under direct vision.

-This technique can usually only be employed if the patient is comatose (unconscious), under general anaesthesia, or has received local or topical anaesthesia to the upper airway structures (e.g., using a local anaesthetic drug such as lidocaine).

-Another alternative is intubation of the patient using a video laryngoscope. -The laryngoscope consists of a handle, usually containing batteries, and an interchangeable blade.

-There are two- styles of laryngoscope blades commercially available: the straight blade, and the curved blade.

-The most popular style of straight blade is the Miller blade, with the Macintosh being the most popular style of curved blade.

-The technique required is slightly different depending on the style of blade being used; in adults, the Macintosh blade is usually preferred by practitioners, whereas with neonates the Miller blade is the most commonly-used style.

-Another common technology used for intubation has been fibre optics, most notably the fibre optic bronchoscope.

-Intubation over a fibre optic bronchoscope is the preferred method for those who have been deemed difficult to intubate using traditional methods.

-Using fibre optic bronchoscopy or rhinoscopy still has its drawbacks, however; it requires a significant degree of skill to manipulate the bronchoscope, making this method somewhat inaccessible to practitioners who are not proficient in its use.

-While traditional intubation with laryngoscopy is ideally achieved in less than 20 seconds, intubation with a bronchoscope can take considerably longer, making its use in emergency situations somewhat limited.

-The above known systems and methods have some drawbacks.

-A first drawback arises by the fact that by said known systems and method the endotracheal tube can be inadvertently placed in the esophagus (right behind the trachea) and therefore adequate respiration will not occur, with consequent brain damage and/or cardiac arrest and/or death. -Furthermore, aspiration of stomach contents can result in pneumonia and acute respiratory distress syndrome (ARDS) a breathing failure that can occur in critically ill persons with underlying illnesses.

-A second drawback arises by the fact that by said known systems and methods, the endotracheal tube can be inadvertently placed too deep, and in this case only one lung being ventilated with consequent result of a pneumothorax as well as of a inadequate ventilation. -A third drawback arises by the fact that by said known systems and methods during endotracheal tube placement, damage can also occur to the teeth, the soft tissues in the back- of the throat, as well as the vocal cords.

-A fourth drawback arises by the fact that intubation with a bronchoscope can take considerably longer, making its use in emergency situations somewhat limited.

Object of the invention

-The object of the present invention is to overcome the above mentioned drawbacks.

-The invention, which is characterized by the claims resolves the problems of creating a system to execute tracheal intubation, in which said system is characterized by the fact to comprise a pair of glasses and an endotracheal assembly, by the fact that said glasses comprise a frontal portion with at least one or more monitors, by the fact that said frontal portion has a determined height to allow the operator to view at least two different visual fields, a first visual field by which the operator can directly observe the face and the oral cavity of the patient and a second visual field by which the operator can observe the monitor; by the fact that said endotracheal assembly comprises an endotracheal tube and optical means able to take the images of the organs that are in front of the distal end of the endotracheal tube, and by the fact that the images take by said optical means are displayed on said one or more monitors.

-The invention, which is characterized by the claims resolves the problems of creating a method to execute the tracheal intubation of a patient, in which said method is characterized by the fact to utilize a system as above mentioned object of the present invention and a laryngoscope which substantially comprises a handgrip and a blade, in which said method comprises the following operations: a)-the operator puts the glasses on the nose; b)-the operator grasps with a first hand the handgrip of the laryngoscope; c)-the operator grasps with a second hand the handgrip of the endotracheal assembly; d)-the operator lowers the tongue of the patient by the blade of the laryngoscope and during said operation said operator uses the first visual field directly observing the face and the oral cavity of the patient; e)-the operator inserts the distal end of the endotracheal tube into the mouth of the patient, still using the first visual field directly observing the face and the oral cavity of the patient; f)-when the distal end of the endotracheal tube is inserted into the oral cavity, the operator provides to further insert the same endotracheal tube towards and into the trachea using two different images, a first image obtained through the first visual field by which the operator can observe the face and the oral cavity of the patient, and a second image obtained through the second visual field by which the operator observing monitors can see the images of the organs that will be step by step met by the distal end of the endotracheal tube .

-By use of the system and the method object of the present invention the operator can perform a rapid and precise intubation of the patient, without abandoning the grasping with the two hands of the endoscope assembly and of the laryngoscope.

-Furthermore, the operator is able to perform the intubation by direct visualization of the oral cavity of the patient and, at the same time, to check the execution of the intubation through visualization of the organs surrounding the distal end of the endotracheal tube.

Brief Description of the Drawings

-Further characteristics and advantages of the present invention will mostly result evident from the description that follows of a preferred embodiment.

-The following description of the system and of the method proposed by the present provisional application is provided by way of non-limiting examples in a reference to the enclosed drawings in which:

>-Figure 1 shows a pair of glasses that form the system object of the present invention;

>-Figure 1A shows the pair glasses of fig. 1 put on the nose of the operator according to a first operative configuration;

>-Figure 1 B shows the pair glasses of fig. 1 put on the nose of the operator according to a second operative configuration;

>-Figure 2 shows an endotracheal assembly that forms the system object of the present invention;

>-Figure 3 shows a laryngoscope.

>-Figure 4 shows the distal portion of the endotracheal assembly inserted into patient. >-Figures 5 and 6 show a third configuration of the system.

Description of the Preferred Embodiment

-Figure 1 illustrates a pair of glasses 100 which are a first component of the system object of the present invention.

-Said glasses 100, substantially comprises a frontal portion 101 which has a determined height H, two arms 102a and 102b, two monitors 103a and 103b connected with a receiver 105, nose pads 104a-104b adjustable in height, a receiver 105 (of the type of radio frequency, bluetooth or other type), and a battery 106, preferably of the rechargeable type, able to power supply the devices previously quoted 103a, 103b, 105.

-With reference to the figure 1A, through said glasses 100, the operator, lifting or lowering the eyes can get two different visual fields and more particularly: >-a first visual cone or visual field, 110, obtained lowering the look, i.e. looking below the glasses, by which the operator can directly observe the face and the oral cavity of the patient; and >-a second visual cone or visual field, 120, obtained lifting the look, i.e. looking directly into the monitor 103a and 103b.

-With reference to the figure 2, it illustrates an endotracheal assembly 200 that is a component of the system of the present invention.

-Substantially, said endotracheal assembly 200 comprises: -an endotracheal tube 210 which is preferably mechanically connectable/associable in a fixable/detachable manner with the handgrip 220 by a flange 212 or other connecting means, in which said handgrip 220 has preferably a cylindrical form and contains a light source 230, a video-camera 240, a transmitter 250 (of the type to radio frequency, bluetooth or other type), a fiber optic 260 and a battery 270 preferably of the rechargeable type, able to power supply the devices previously quoted 230, 240, 250. -Also the fiber optics 260 placed within the endotracheal tube 210 is mechanically connectable/associable in a fixable/detachable manner with instruments of the handgrip 220.

-The light source 230 the video-camera 240 the transmitter 250 the fiber optic 260 and the battery 270 are connected among them, with the purpose of projecting light energy at the distal end 261 of the fiber optic 260, in order to take the images that are in front of the same distal end 261 by the video-camera 240, and in order to transmit the images through the transmitter 250 to the receiver 105 of the glasses 100.

-More particularly, the fiber optic 260 extends into and along the endotracheal tube 210 with the distal end 261 positioned in proximity of the distal end 211 of said endotracheal tube 210.

-With such structuring, the fiber optic 260 illuminates the organs that are in front of the distal end 211 of the endotracheal tube 210 and, at the same time, it also takes the images that are in front of the same distal end 211.

-With reference to the figure 3, it illustrates a laryngoscope 300 which substantially comprise a handgrip 310 and a blade 320, as also the battery and one or more light sources.

-With such system and with the laryngoscope 300, see fig. 4, in order to execute an oro-tracheal intubation of a patient, the following operations are executed: a)-the operator puts the glasses 100 on the nose; b)-the operator grasps by a first hand M1 the handgrip 310 of the laryngoscope 300; c)-the operator grasps with a second hand M2 the handgrip 220 of the endotracheal assembly 200; d)-the operator lowers the tongue of the patient with the blade 320 of the laryngoscope 300 and during said operation he uses the first visual field 110, therefore said operator directly observes the face and the oral cavity of the patient; e)-the operator inserts the distal end of the endotracheal tube into the mouth of the patient, still using the first visual field 110 and, therefore, directly observing the face and the oral cavity of the patient; f)-when the distal end 211 of the endotracheal tube 210 is inserted into the oral cavity, the operator provides to further insert the same endotracheal tube 210 towards and into the trachea using two images, a first image obtained through the first visual field 110, by which the operator can directly observe the face and the oral cavity of the patient, and a second image obtained through the second visual field 120, by which the operator, observing monitors 103a and 103b can see the images of the organs (larynx, epiglottis, vocal cords, trachea, etc.) that will be step by step met by the distal end 211 of the endotracheal tube 210, during the operation of insertion of the same endotracheal tube toward and into the trachea.

-With reference to the insertion of the endotracheal tube into the trachea, please note that during this operative step the attention of the physician would be focused on precisely positioning of the distal end 211 of the endotracheal tube with respect to the bronchi bifurcation.

-Furthermore, during and/or after the cuff inflation 214 of the endotracheal tube

210, in which said operation can cause movement of the endotracheal tube with respect to the tracheal, the operator can check the correct positioning of the distal end 211 of the same endotracheal tube 210 with respect to the bronchi bifurcation.

-Likewise, the same operator can check if a wrong positioning of the distal end 211 of the endotracheal tube 210 into the left or right bronchus has happened, resolving the problems above mentioned.

-In such context, the operator can perform the aforesaid operations without abandoning the grasping of the endotracheal assembly 200 and of the laryngoscope 300.

-Furthermore, the operator can perform the tracheal intubation directly observing the face and the oral cavity of the patient and, therefore, he can execute said intubation in a rapid manner and, at the same time, he can indirectly observe the images of organs that are in front of the distal end 211 of the endotracheal tube 210, obviating the above mentioned drawbacks about a wrong insertion or a wrong positioning of the endotracheal tube 210.

-When the operator has positioned the endotracheal tube 210 and inflated the cuff 214 as above described, the same operator can dissociate the handgrip 220 with respect to the endotracheal tube 210 with the fiber optics 260, and in this manner, for example, the proximal end 213 of the endotracheal tube 210 can be associate with a system of forced ventilation e/o for other applications.

Description of a Second Configuration

-With reference to Fig. 1 B and to the above description, according to a second configuration, through said glasses 100 the operator lifting or lowering the eyes can get two different visual fields and more particularly: >-a first visual cone or visual field, B-110, obtained by lifting the look, by which the operator can directly observe the face and the oral cavity of the patient; and >-a second visual cone or visual field, B-120, obtained by lowering the look, by which the operator can observe the monitors 103a and 103b.

Description of a Third Configuration -With reference to Figs. 5 and 6, according to a third configuration, the glasses 100 and the endotracheal assembly 200 are connected between them by a cable C-251 and C-106. -

-More in particular the glasses 100 comprises a receiver C-105 with a cable C- 106 and the endotracheal assembly 200 comprises a transmitter C-250 with a cable C-251 , in which the free ends of said cables C-106 and C-251 can be connected between them.

. -The above description of the system and of the method to execute a tracheal intubation is provided solely by way of non-limiting example, and clearly, therefore, said system and of the method can be modified or varied in any way suggested by experience and/or by their use.