A tracheal aid

Abstract

A tracheal device for the assisted respiration of a patient includes a first tube having a proximal end to be arranged protruding from the mouth of the patient and connectable to a device for assisted respiration, a distal end adapted to cover an orifice, and a first sealing element coupled externally to the first tube. The tracheal device also includes a second tube having a distal end adapted to cover the orifice, a second sealing element coupled externally to the second tube, and a flexible and collapsible service duct stably coupled to the first tube and the second tube to allow the service duct and the first and the second tubes to be arranged in two configurations.

Claims

1. A tracheal device adapted for assisted respiration of a patient, comprising: a first tube, having a proximal end to be arranged protruding from a mouth of the patient and connectable to an assisted respiration device, and a distal end adapted to cover an orifice (O); a first sealing element coupled to an outer surface said first tube; a second tube having a distal end adapted to cover the orifice; a second sealing element coupled to an outer surface of said second tube; and a flexible and collapsible service duct stably coupled to said first tube and said second tube to allow said service duct and said first and said second tubes to be arranged in a first configuration, in which said distal end of said first tube is inserted into a supraglottic region of the patient and said distal end of said second tube is inserted into an esophagus of the patient, and in a second configuration,. in which said distal end of said first tube is inserted into a trachea of the patient and said distal end of said second tube is inserted into the esophagus of the patient.

2. The tracheal device according to claim 1, wherein said service duct is stably coupled to a portion of said first tube located between said first sealing element said proximal end of said first tube.

3. The tracheal device according to claim 1, further comprising one or more medical accessories adapted to cover said service duct.

4. The tracheal device according to claim 3, wherein said one or more medical accessories are selected from the group consisting of gastric probes, obturators, and optical instruments.

5. The tracheal device according to claim 1, wherein said first sealing element is a first inflatable cuff connected to a first duct for passage of inflation fluid.

6. The tracheal device according to claim 1, wherein said second sealing element comprises a second inflatable cuff connected to a second duct for passage of inflation fluid.

7. The tracheal device according to claim 1, wherein said second sealing element comprises one or more elastically deformable bodies wrapping said second tube and arranged to be interposed between said second tube and one or more mucosal walls creating, by deformation, a fluid seal therewith, each of said one or more elastically deformable bodies comprising a casing which hermetically closes an inner portion so as to make it-said inner portion inaccessible from outside.

8. The tracheal device according to claim 7, wherein said one or more elastically deformable bodies comprise a plurality of discoid elements arranged radially to said second tube, material vacancy areas being interposed between said discoid elements, said casing being formed by an outer surface of each of said discoid elements and said inner portion being formed by a thickness of said discoid elements.

9. The tracheal device according to claim 7, further comprising an inflatable blister interposed between said second tube and said one or more elastically deformable bodies.

10. The tracheal device according to claim 1, wherein said second tube comprises two or more lumens, at least one of said one or more lumens being fluidly coupled to said service duct.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Further features and advantages of the invention will become more evident in light of the detailed description of a preferred but not exclusive embodiment of a tracheal device according to the invention, illustrated by way of non-limiting example with the aid of the accompanying drawings, in which:

[0038] FIG. 1 shows a tracheal device according to the invention;

[0039] FIGS. 2 and 3 show the tracheal device of FIG. 1 in different operating steps.

DETAILED DESCRIPTION OF SOME PREFERRED EMBODIMENTS

[0040] With reference to the above-mentioned figures, and in particular to FIGS. 1 and 2, a tracheal device 1 according to the invention is described herein. It is adapted to be inserted by the mouth B into a patient P and comprises a first tube 2 having a proximal end 3 protruding from the mouth B of the patient P and connectable to a device for assisted ventilation. The latter is not the subject of the present patent and is not shown in the figures.

[0041] The proximal end 3 has a sealed fitting 4 connectable to the respirator for the passage of fluids for the respiration of the patient P.

[0042] The distal proximity 6 of the first tube 2, opposite the aforementioned proximal end 3, is usable to cover an orifice 0 such as, for example, the supraglottic region L or the trachea T.

[0043] According to an aspect of the invention, a sealing element 8 is present which is externally coupled to the aforementioned first tube 2.

[0044] In the preferred embodiment of the invention, this sealing element 8 is a first cuff 9 connected to a pipe 10 terminating outside the patient P and also having a sealed fitting 12. The latter can be used to inflate the cuff 9 using, for example, a syringe. Usually, the inflatable cuff 9 is arranged near the distal end 6 of the first tube 2.

[0045] Obviously, this aspect should not be considered limiting for different embodiments of the invention, where, for example, the first sealing element does not comprise a cuff but one or more equivalent elements.

[0046] According to another aspect of the invention, the tracheal device 1 comprises a second tube 14 also having the distal end 15 usable for covering an orifice O which typically consists of the oesophagus E.

[0047] Typically, but not necessarily, both tubes 2 and 14 have a shape and size such that they can be inserted into the trachea T, however, as mentioned, for a correct operation of the device of the invention 1 the second tube 14 is inserted into the oesophagus E.

[0048] Typically, but not necessarily, the tubes 2 and 14 are cylindrical and made of biocompatible materials.

[0049] According to another aspect of the invention, the second tube 14 is also externally coupled to a second sealing element 16 which allows the oesophagus E to be blocked when the second tube 14 is inserted therein so as to avoid the passage of any gastric regurgitations.

[0050] According to a further aspect of the invention, the tracheal device 1 also comprises a service duct 20 stably coupled to the two tracheal tubes 2 and 14. Typically, but not necessarily, this duct 20 is stably coupled to a portion of the first tube 2 identified between the first sealing element 8 and the proximal end 3.

[0051] Furthermore, the duct 20 is flexible so as to allow the device 1 to be arranged according to two distinct configurations. There is a first configuration in which the distal end 6 of the first tube 2 is inserted into the supraglottic region L of the patient P, while the distal end 15 of the second tube 14 is inserted into the oesophagus E. In this configuration, the first sealing element 8, which acts on the supraglottic region L, allows the tracheal device 1 to perform the function of a supraglottic airway device.

[0052] Instead in the second configuration, the distal end 6 of the first tube 2 is inserted into the trachea T of the patient P, while the distal end 15 of the second tube 14 is inserted into the oesophagus E. In this configuration, the first sealing element 8 allows the trachea T to be blocked, stabilizing the first tube 2, while the second sealing element 16 allows the oesophagus E to be blocked, preventing the passage of regurgitations from the stomach. Consequently, in such a configuration the tracheal device 1 of the invention performs the function of an endotracheal tube.

[0053] Advantageously, therefore, the service duct 20 always allows to arrange the tracheal device 1 so as to ensure the ventilation of the patient.

[0054] The tracheal device 1 allows, still advantageously, to be used both as a supraglottic airway device (first configuration) and as an endotracheal tube (second configuration). Moreover, the structure thereof allows to switch from one configuration to another reversibly and without extracting the device 1 from the patient P.

[0055] Still advantageously, since the transition from the configuration as supraglottic airway device to the configuration as endotracheal tube may be performed without extracting the tracheal device 1, the periods of apnea to which the patient P is subjected are minimized, if not cancelled.

[0056] In addition to this, the service duct 20 is collapsible, i.e., free to collapse, making the walls touch so as to be blocked.

[0057] Advantageously, therefore, the service duct 20 minimizes, if not eliminates, the difficulties of blocking the orifices O, allowing the sealing elements 8 and 16 to adapt to the mucosal walls M in which they are inserted, achieving an optimal fluidic seal. Moreover, the same service duct 20 is typically made with material such as to reduce hindering the blocking mentioned above, even if it is not collapsed.

[0058] Still advantageously, the service duct 20 puts the oesophagus E of the patient P in fluidic communication with the external environment. This duct 20 is typically hollow and therefore advantageously allows the expulsion of the fluids regurgitated by the stomach due to the pressure exerted by the latter (passive expulsion). In fact, this pressure allows to reverse the collapse process of the duct 20, opening it.

[0059] Obviously, this aspect should not be considered limiting for different embodiments of the invention, where, for example, the tracheal device comprises multiple service ducts.

[0060] According to another aspect of the invention not shown in the figures, the tracheal device 1 of the invention also comprises one or more medical accessories capable of covering the service duct 20. These accessories belong to the group comprising gastric probes, obturators and optical instruments. However, they can be used simultaneously in the aforementioned case of the presence of several service ducts.

[0061] Advantageously, such medical accessories make it possible to render the service duct 20 active. In this sense, it can be used to provide for the outflow of regurgitated fluids and the artificial nutrition of patients by covering it with a gastric tube, or it can be used to facilitate the insertion of the tracheal device 1 in the patient by covering it with an obturator. Further, it may be covered by optical instruments for visual inspection of the orifices 0. In all such cases, still advantageously, the service duct 20 allows the use of the medical accessories without problems of operation of the sealing elements 8 and 16 as well as without problems of compatibility with the mucosal walls M of the accessories since they do not come into contact therewith.

[0062] With regard to the second sealing element 16, according to the described embodiment, it comprises several elastically deformable bodies 23 arranged wrapping the second tube 14 to be interposed between the same and the mucosal walls M. In this way they create a fluidic seal through the deformation thereof. The number of deformable bodies should not be considered limiting for different embodiments of the invention where, for example, there is only one.

[0063] Advantageously, the deformable bodies 16 wrapping the second tube 14, being adaptable to the mucosal walls M, allow an optimal blocking of the oesophageal orifice O.

[0064] In the embodiment described, the deformable bodies 23 comprise several discoid elements 28 arranged radially to the second tube 14 and between which material vacancy areas 29 are interposed.

[0065] Still advantageously, the fluidic seal of the oesophagus E is obtained without any intervention of the staff using the tracheal device 1. Moreover, if the second sealing element consists of an inflatable cuff, an important aspect is that it must not be inflated excessively in order to avoid damage to the mucosal walls. According to the embodiment shown in the figures, this is instead advantageously excluded. The possibility of human error is therefore excluded, especially in the case of use by inexperienced or hardly experienced staff.

[0066] Obviously, the manufacture of the sealing element is a feature which should not be understood in a limiting sense for the present invention. In particular, an alternative embodiment where the second sealing element comprises a second inflatable cuff connected to at least a second pipe for the passage of inflation fluid is not excluded. According to this embodiment, not shown in the figures, this second duct can be coupled externally to the service duct or embedded in the walls thereof.

[0067] Further, according to different embodiments not shown in the figures, the deformable bodies are formed by a single body shaped as a full ellipsoid or, according to further different embodiments also not represented herein, by a plurality of full ellipsoid or spherical bodies.

[0068] In the drawings it can be seen that, according to the embodiment represented therein, the discoid elements 23 have increasing extensions starting from the distal end 15 of the second tube 14. Advantageously, this allows to obtain a progressive fluidic seal which is well suited to different oesophageal dimensions from patient to patient without the risk of subjecting the mucosal walls M to excessive pressure.

[0069] Obviously, this aspect should not be considered limiting for different embodiments of the invention, where, for example, the discoid elements are of any extension, of different forms or all equal to each other.

[0070] With regard to the material vacancy areas 29, the contact of the discoid elements 28 with the mucosal walls M allows to obtain a succession of decompression chambers 30 which allow an outlet for the regurgitation of fluids coming from the stomach while preventing the access thereof to the airways.

[0071] According to another aspect of the invention, each of the deformable bodies 23 comprises a casing 33 which hermetically seals an inner portion thereof 34 so as to render it inaccessible from the outside. In such a case, as specified above, it does not need to be inflated or filled in the operating step with any solid, liquid or gas.

[0072] Advantageously, the aforementioned shape allows to differentiate the materials of the casing 33 and the inner portion 34 so as to optimize the function thereof. In particular, the casing 33 must correctly adhere to the mucosal walls M and the choice of material allows this property to be optimized while limiting the use of biocompatible materials. At the same time, materials more adapted for obtaining the desired pressure on the mucosal walls M may be used for the inner portion. Moreover, advantageously, this configuration makes it possible to obtain the inner portion 34 also with materials in the liquid or gaseous state.

[0073] Obviously, this aspect should not be considered limiting for different embodiments of the invention, where the deformable bodies are obtained in a single body and with a single material.

[0074] In the case of the embodiment of the invention shown in the figures, in the discoid elements 28 the casing 33 is formed by the outer surface 36 of each discoid element 28, while the inner portion 34, is formed by the thickness 37 thereof.

[0075] According to a further aspect of the invention, not visible in the figures, the second tube 14 comprises two or more lumens, at least one of which is fluidly coupled to the service duct 20.

[0076] Advantageously, the presence of two or more lumens allows to be able to make them adapted to be covered by accessory devices such as, for example, optical instruments or the like.

[0077] Obviously, this aspect should not be considered limiting for different embodiments of the invention, where, for example, the second tube comprises a single lumen.

[0078] According to different embodiments of the invention, not shown herein, the tracheal device comprises a further medical accessory, i.e., a semi-rigid stylet shaped to cover the two tubes. Said stylet is removable and the functionality thereof is to keep the tubes mutually aligned during the insertion thereof into the patient. After insertion, the stylet is extracted so as to leave the flexible junction element freedom of action.

[0079] Moreover, according to a further embodiment not shown in the figures, the stylet may be coupled to additional medical devices useful for the insertion thereof, such as, for example, instruments provided with final optics.

[0080] Advantageously, the presence of an optical detection instrument allows the user to guide the insertion of the tracheal device with the possibility of seeing the orifice being covered.

[0081] According to further embodiments, however, such auxiliary medical devices, and in particular the imaging means, are coupled to the distal end of the second tube or to different parts thereof.

[0082] According to another embodiment, the metal stylet has a tip which is steerable by means of a cable. Advantageously, in this manner the user can improve the steering of the device in the insertion into the patient's orifices.

[0083] According to a further embodiment, the tracheal device also comprises an inflatable blister interposed between the second tube and the elastically deformable bodies. This blister can be inflated as needed by the operator through a pipe.

[0084] Advantageously, the inflation of said blister exerts a pressure on the inner parts of the deformable bodies so as to cause the slight expansion thereof, which results in an increase in the pressure they exert against the mucosal walls. This allows to further stabilize the fluidic seal of the oesophageal device.

[0085] Operationally, the user inserts the tracheal device 1 of the invention into the mouth B of the patient P. In the absence of airway inspection (“blind” insertion), the second tube 14 most likely covers the oesophagus E, as shown in FIG. 2. It follows that with this operation the discoid elements 28, interposed between the mucosal walls M and the second tube 14, block the oesophagus E, obtaining a fluidic seal which preserves the airways from any regurgitated fluids. Moreover, these can be evacuated through the service duct 20 passively capable of dilating.

[0086] In the case in which the user wishes to use the device 1 of the invention as a supraglottic airway device, the user continues with the insertion until the first cuff 9 associated with the first tube 2 reaches the supraglottic region L. Subsequently, the user can proceed with the inflation of the cuff 9, blocking the supraglottic region L.

[0087] The user can then connect the assisted respiration device to the sealed fitting 4 present at the proximal end 3 of the first tube 2, successfully ventilating the patient P.

[0088] If it is necessary to proceed, also later, with the intubation of the patient P, passing from the supraglottic airway device configuration to an endotracheal tube configuration, it is not necessary to remove the device 1. In fact, it is sufficient to proceed, as shown in FIG. 3, to insert the distal end 6 of the first tube 2 into the trachea T. This operation can advantageously be carried out without removing the second tube 14 thanks to the flexibility of the service duct 20 which allows the distal end 6 of the first tube 2 to cover a different orifice O than the one covered by the second tube 14.

[0089] Advantageously, accordingly, it is demonstrated that the tracheal device 1 of the invention can be used both as a supraglottic airway device and as an endotracheal tube.

[0090] Still advantageously, such transformation from one configuration to another is reversible any number of times.

[0091] In addition, still advantageously, since the transition from the configuration as supraglottic airway device to the configuration as endotracheal tube may be performed without extracting the tracheal device 1 of the invention, the periods of apnea to which the patient is subjected are minimized, if not cancelled.

[0092] Typically, but not necessarily, the transformation from supraglottic airway device to tracheal tube operatively takes place by first inserting a fibroscope into the first tube 2 to locate the trachea T, then the trachea T is covered with the fibroscope, then the cuff 9 is deflated, still in the supraglottic region L, and finally the first tube 2 is inserted into the trachea T using the fibroscope as a guide. Obviously, the use of the fibroscope is optional and this procedure should not be considered limiting for the present invention since the same operation can be carried out with a more traditional laryngoscopy.

[0093] Following insertion into the trachea T, the cuff 9 is inflated, ending the transformation of the device 1 of the invention from supraglottic airway device to endotracheal tube.

[0094] What emerges from all the above is that the tracheal device 1 of the invention can always be used “blindly”, that is, in the absence of airway inspection without jeopardizing the failure of the application of assisted respiration to the patient P. In addition, this operation can advantageously be carried out by inexperienced staff and also in critical situations of the patient P.

[0095] In light of the above, it is to be understood that the tracheal device of the invention overcomes the drawbacks of the known art, being easy to apply on any patient in any state they may be found.

[0096] In particular, it can also be used successfully by inexperienced staff, allowing the use of a single product capable of being configured as a supraglottic airway device and endotracheal tube, avoiding replacement/extraction procedures to make the transition from one to the other, also repeated.

[0097] The device of the invention also allows to make the transition from one configuration to another in a reversible manner and limiting, if not cancelling, the time in which the patient is in an apnea condition.

[0098] Furthermore, the device of the invention comprises a collapsible service duct which, in addition to putting the oesophagus in fluidic communication with the external environment to expel the regurgitation fluids coming from the stomach, allows the sealing elements to adapt to the mucosal walls of the orifices in which the device is inserted, achieving optimal blocking.

[0099] The aforementioned duct is then adapted to be covered by multiple medical accessories, for example gastric probes, obturators or optical instruments.

[0100] In addition, the tracheal device of the invention is shaped to block the oesophagus by progressively adapting to the mucosal walls of the orifice, so as to prevent regurgitated fluids from reaching the airway.

[0101] Finally, the tracheal device of the invention, adapted for use both in the supraglottic airway device configuration and as a tracheal tube, is configured to be inserted “blindly”, making it suitable for use even by inexperienced staff.

[0102] The invention might be subject to many changes and variants, which are all included in the appended claims. Moreover, all the details and steps may furthermore be replaced by other technically equivalent elements, and the materials may be different depending on the needs, without departing from the protection scope of the invention defined by the appended claims.