IT202000004645A1 - MEDICAL-SURGICAL INSTRUMENT. - Google Patents

Description

Title: MEDICAL-SURGICAL INSTRUMENT.

DESCRIPTION

The present invention relates to a medical-surgical instrument.

In the medical-surgical sector,? now well known and widely used a medical-surgical device called "laryngeal mask" (which is sometimes referred to with the acronym "LMA", from the English phrase "Laryngeal Mask Airway"), which is used in the airways during resuscitation procedures or under anesthesia.

Pi? in detail, the laryngeal mask includes a curved main tube, which is inserted into the cavity. oral of a patient up to support the end? distal against the aditus of the larynx. Just the end? distal tube has a sort of mask whose edge? consisting of a cuff (inflatable or not) which is substantially made to adhere to the patient's anatomical tissue.

After placing the headset,? cos? It is possible to send oxygen and / or apply positive pressure through the tube and achieve effective ventilation of the lungs, even when the patient is not? able to autonomously provide for breathing.

Over time, others have been added to the primary use outlined above, which exploit the direct connection with the lungs and other organs of the respiratory system generated by the tube.

Pi? in detail, ? note the practice of introducing an additional tube or catheter into the main tube, up to bring the end? distal of the latter substantially in correspondence with the cuff. In this way, in fact, the progressive introduction of the catheter takes place in an atraumatic way, since the main tube "protects" the anatomical tissues from injuries or abrasions that could otherwise occur in the event of unwanted collisions.

Through the catheter? cos? possible to insufflate therapeutic substances of various types, which can reach directly and therefore more? effective the lungs or in any case the air organs pi? deep.

This implementation solution is not? for? without drawbacks.

To ensure that the totality? of the therapeutic substance delivered actually reaches the lungs, or in any case the designated organs,? an optimal positioning of the extremity is necessary? distal of the catheter, which preferably should protrude a few millimeters or centimeters beyond the cuff. to be introduced (albeit to a limited extent) into the larynx itself, going beyond the vocal cords.

In fact, if the introduction of the catheter was stopped before the position indicated above, part of the substance could end up in the esophagus (the adhesion of the cuff to the tissues is never perfectly sealed) or go back towards the cavity. oral, reducing the effectiveness of the treatment (however, not easily replicable, also given the huge costs of some substances used).

Conversely, if the catheter were introduced too far beyond the vocal cords, the "protection" offered by the main tube would be lacking and, again, there would be a risk of injury or abrasion to the patient's anatomical tissues.

As for? ? quite evident, it is often difficult to obtain the desired optimal positioning of the catheter, even observing all the necessary precautions, given the remote position that its extremity? must occupy and the obstacles and impediments that normally arise during procedures so? delicate such as those for resuscitation or anesthesia.

The situation is even more? critical if it is observed that the techniques described above are widely used for the treatment of premature babies, where therefore the available spaces are even more? narrow and the margins of error much more? restricted.

The main aim of the present invention? that of solving the above problems, creating a medical-surgical instrument that ensures practical modalities? of introduction and positioning of a catheter, and of its distal end portion in particular, in a cavity? anatomy of any patient, and along its respiratory tract in particular.

Within the scope of this aim, an object of the invention? to create a tool that allows practical modalities? ventilation of a patient's lungs and insufflation of a further substance, avoiding the danger that part of the latter may disperse without reaching the designated goal.

Another object of the invention? to create a tool that ensures high reliability? of operation and practical modalities? of use. Another object of the invention? that of proposing an instrument that adopts an alternative technical and structural architecture to those of known instruments.

Not the least object of the invention? to create a tool that is easily obtainable starting from commonly available elements and materials? on the market.

Yet another object of the invention? that of creating an instrument of low cost and safe application.

This task and these and other purposes which will become clearer in the following are achieved by a medical surgical instrument, comprising: a main tube, which can be inserted in at least one anatomical duct of a patient and has one extremity? proximal and one extremity? distal, an anatomical mask placed in correspondence of said extremity distal and having an enlarged peripheral edge, configured for stable support on an anatomical tissue of the patient, characterized in that it comprises: a seat configured for housing, even temporarily, an electronic vision device, and an inflatable casing, internally fixed to said tube at said end? distal and associated with a respective swelling line. Further characteristics and advantages of the invention will become clearer from the description of a preferred but not exclusive embodiment of the instrument according to the invention, illustrated by way of non-limiting example, in the accompanying drawings, in which:

Figure 1 is a partially exploded axonometric view of the instrument according to the invention;

Figures 2 to 6 show the use of the instrument in successive stages, sectioned along a sagittal plane;

Figures 7 and 8 are highly enlarged details of Figures 5 and 6 respectively;

Figures 9-11 show in sequence the final stages of introducing a further accessory into the main tube and, more? in detail:

figure 10? a section of figure 7, taken along the X-X axis;

figure 11? a section of figure 8, taken along the XI-XI axis.

With particular reference to the aforementioned figures,? globally indicated with the reference number 1, a medical-surgical instrument, which first of all comprises a main tube 2, which can? be inserted (typically only partially) in at least one anatomical duct of a patient A and which has an extremity? proximal 2a and one extremity? distal 2b. The end? proximal 2a? the one that is maintained more? close to the user and with which the latter interacts during use while, on the opposite side, the extremity? distal 2b? the one that first and most? it is fully inserted into the duct.

It should be noted from now on that in the preferred application of the invention the tube 2 is introduced into the oral cavity B and therefore into the pharynx C: in fact, in this case the instrument 1? an extra-glottic device that is used as a "laryngeal mask" (or "Laryngeal Mask Airway", or "LMA"), but with the important and peculiar innovations that will be described later. In the following (as indeed in the attached figures) it will be done? often refers to this preferred application, in which the instrument 1 is used to ensure the assisted ventilation of patient A, typically but not necessarily a newborn, and the administration of an additional substance, in case of anesthesia, during resuscitation and / or for other treatments to be performed on the newborn, in particular in the case of premature births.

Does it help for? underline that the scope of application and therefore the protection claimed here must not be construed as limited to the specific example indicated above: according to the specific needs, in fact, the possibility is foreseen? to insert the instrument 1 in ducts of any type for patients A of any age? and sex, suffering from various pathologies or in any case in need of care of various kinds.

The instrument 1 comprises an anatomical mask 3 which? (solidly) arranged at the extremity? distal 2b of tube 2 and which has an enlarged peripheral edge 3a (a sort of cuff), configured to rest stably on an anatomical tissue of patient A.

The edge 3a can? consist of an inflatable pad or in any case an enlarged lip made of silicone (or similar materials); in any case it rests stably on the designated anatomical tissue ensuring a partial seal.

In your favorite application you? already? referenced, the edge 3a rests around the epiglottis D (and more precisely on the upper esophageal sphincter, upstream of the vocal cords), with the extremity? distal 2b which remains turned (and open) substantially towards the larynx E (instead excluding the esophagus F). The arrangement cos? obtained? shown in figure 3.

So far, however, the tool 1 can? be made in a similar way to the laryngeal masks of the known type (and inserted in the oral cavity B in the same way) and therefore we will not dwell on it. further on the respective construction details, as already? well known to the person skilled in the art.

According to the invention, the instrument 1 comprises a seat 4 configured for housing, even temporarily, an electronic viewing device 5 (which, as will be further explained, may or may not be included in the instrument 1): more? in detail, the location and shape of the seat 4 are chosen in such a way that the device 5, once installed, is able to acquire and transmit in real time images relating to the passage opening defined by the end. distal 2b and / or to the inner contour of the edge 3a (and obviously of the immediately adjacent areas). By housing the device 5 in the seat 4, therefore, whoever interacts with the instrument 1 can? to view the anatomical areas surrounding the extremity? distal 2b (otherwise closed to sight, for obvious reasons).

Furthermore, the instrument 1 comprises an inflatable casing 6, which? internally fixed to the tube 2 at the end? distal 2b (and of the edge 3a) and what? associated with a respective inflation line 7 (which allows the envelope 6 to be filled with air or other fluid when the latter is already introduced into the anatomical duct of patient A).

Tool 1 can include (be supplied with) an accessory such as a catheter 8, a probe (a tracheal probe for example), or the like, which can? be removably introduced into the tube 2 at the end? proximal 2a of the latter, in particular when the tube 2 itself? introduced and positioned in the desired anatomical duct (figure 4). Alternatively, this catheter 8 (or other) can? be found separately. In any case, in the instrument 1 the electronic vision device 5 and the envelope 6 cooperate (in the modalities that will be described below), to ensure optimal positioning of the distal terminal portion 8a of the catheter 8 inside the anatomical duct of the patient A.

Also the electronic vision device 5 can? be found separately (and therefore not supplied directly with the instrument 1): for example, for an effective application of the invention a hospital or other health facility can use 5 gi? provided, using them from time to time, when different needs arise, in cooperation with instrument 1 or for other medical surgical practices.

In a form of considerable practical interest, on the other hand, the instrument 1 comprises the electronic vision device 5 and is therefore supplied with the latter already? housed (removably or rigidly) in seat 4, or even loose. In any case, this device 5? configured to acquire and transmit in real time images relating to the light of passage defined by the extremity? distal 2b and / or to the inner contour of the edge 3a.

In particular, the main tube 2 has a curved longitudinal development (so as to accommodate the conformation of the oral cavity B and of the pharynx C) and, as in the attached figures, the envelope 6? placed at the edge of the end? distal 2b arranged diametrically on the opposite side with respect to the ideal center of curvature of the tube 2 (at the point furthest from the ideal center of curvature).

It is however specified how the shape of the tube 2 (in particular the choice of giving it a straight or curved development) and the location of the casing 6 can vary according to the specific application, without thereby? fall outside the scope of protection claimed here.

In the preferred embodiment, illustrated in figures 9-11 annexed by way of non-limiting example of the application of the invention, the casing 6 has, at least in an active configuration, which can? be obtained following the swelling operated by the line 7, two lateral swellings 6a, placed side by side along a plane transversal to the longitudinal axis of the tube 2, and a central inlet 6b, interposed between the swellings 6a. This peculiar conformation (which evokes the humps of a camel) can? be obtained by suitably dimensioning the casing 6 and / or giving different stiffness and thickness to its various parts, or in another way, according to specific requirements.

The specific location of the inflation line 7 with respect to the tube 2 (as well as the modalities with which the first is linked to the second) can? vary according to specific needs. A first chance? however, it provides that at least a fraction of this line 7 is integrated into the thickness of the main pipe 2.

A second chance? on the other hand, it provides for at least a fraction of this line 7 to be stably applied to the internal side surface of the main pipe 2.

A third possibility? also provides? that at least a fraction of this line 7 is stably applied to the external lateral surface of the main pipe 2.

In practice, the layout of line 7 and the modalities? of constraint to tube 2 can correspond to a combination of two or more? of the possibilities? indicated above or also be made according to further options, without departing from the scope of protection claimed herein.

In order to facilitate the inflating operations, and therefore the sending of air or other fluid to the casing 6 (which can be carried out in any way, without departing from the scope of protection defined here), the line 7? associated, on the opposite side to the envelope 6, to an inflatable lung 9.

The lung 9? placed outside the tube 2 (near the proximal end 2a) and d? equipped with an entrance 9a, which? operationally placed on the opposite side to line 7 and? equipped with a one-way fluid passage valve, configured for the selective consent to the filling of the lung 9 and the obstacle to emptying.

In use therefore, in anticipation of the use of the instrument 1 for the treatment of a patient A, it is envisaged to first fill the lung 9 with air (or other fluid). resort to a syringe 10 (Figure 2) or to another device, which can be associated with the lung 9 to store air in the latter.

In this context, can you? provide that the inlet 9a is configured to allow for the entry of air simply by effect of the connection to the syringe 10 or of the pressure gradient generated by pressing on the syringe 10 or on the lung 9 itself.

In any case, the valve? then able to prevent the escape of air and therefore the lung 9 remains temporarily inflated (full of air or other fluid), as in figures 2-4.

When the user wishes to inflate the envelope 6,? it is sufficient to press on the lung 9 (figure 5): following the pressure imparted, in fact, the lung 9 deflates and the air (or other fluid) runs along the line 7 until it fills the envelope 6, thus obtaining the desired swelling.

If the user wishes to deflate the envelope 6, it will be? it is sufficient to reduce the pressure on the lung 9 (or cancel it completely), to induce the air to follow the opposite path.

Conveniently, in the preferred embodiment the seat 4 comprises at least one auxiliary channel, which leads to the end? distal 2b of tube 2 and that can? be used for the introduction and housing, even temporary, of the electronic vision device 5, so? as of a further medical device, such as a probe, an aspirator, etc. However, it is envisaged that the instrument 1 can be provided with any number of channels, according to the number of tools to be used.

The specific location of the groove with respect to pipe 2 (as well as the modalities with which the first is bound to the second) can? vary according to specific needs.

A first chance? however, it provides that at least a fraction of this groove is integrated into the thickness of the main tube 2 (as in the attached figures).

A second chance? on the other hand, it provides for at least a fraction of this channel to be stably applied to the internal side surface of the main pipe 2.

A third possibility? also provides? that at least a fraction of this channel is stably applied to the external lateral surface of the main pipe 2.

In practice, however, the disposition of the channel (or in any case of the seat 4) and the modalities? of constraint to tube 2 can correspond to a combination of two or more? of the possibilities? indicated above or also be made according to further options, without departing from the scope of protection claimed herein.

The choice of providing a channel allows the viewing device 5 to be housed in a removable way, facilitating the operations of removal and replacement of the same. as the possibility? to reconvert the same channel to another use, if necessary.

In an embodiment of considerable practical interest, cited by way of example and not limiting the application of the invention, the electronic viewing device 5 comprises a video camera 5a, which can at least temporarily be placed in the vicinity of the device. of the extremity? distal 2b of the main tube 2, to direct its visual field (schematically indicated with dashed lines in figures 4-8) towards the extremity? distal 2b and / or the internal contour of the edge 3a (and the adjacent areas, in particular those downstream).

It should be noted how typically the video camera 5a is anchored to one end of a wire 5b housed in the groove.

The 5a camera can? be operatively associated (for example by means of wire 5b) to a screen (supplied together with the instrument 1 or found separately), for displaying the acquired images in real time.

Advantageously, the extremity? proximal 2a of main tube 2? coupled to a "Y" -shaped fitting 11, which defines two mutually independent access openings 11a to the main pipe 2. The use of the instrument according to the invention is described below in relation to the junction. cited favorite application, but will result? It is clear to the person skilled in the art that, mutatis mutandis, the indications and considerations developed in the next paragraphs can be easily extended and adopted also in different contexts, for different anatomical conduits, while remaining within the scope of protection claimed herein.

In view of the use of the instrument 1, the user (the surgeon, the anesthetist, the neonatologist, the specialized operator, etc.) fills the lung 9 with air or other fluid, for example using a syringe 10 (figure 2 ). It is emphasized how the use of the lung 9 allows to control in a more? I practice the inflation and deflation of the envelope 6, but it is not excluded to foresee other modalities? of sending air through line 7, which are independent of the lung 9.

The use of the instrument 1 therefore provides that the tube 2 is inserted in the oral cavity B and then in the pharynx C, until the extremity is firmly supported. distal 2b on the upper esophageal sphincter, upstream of the vocal cords (Figure 3). The connection 11 (if foreseen) can? be bound before or after the aforementioned phase but, in any case, this condition reached? It is possible to send oxygen or air (but also any other substance) through the tube 2 itself, for example to ensure ventilation of the lungs (as required during resuscitation, anesthesia, or in other particular clinical conditions).

It should now be noted that in many contexts it is required or preferable to insert the catheter 8 into the tube 2, to insufflate the lungs or in any case into the smaller airways. deep a further substance, and then give another treatment in addition to the ventilation already? mentioned. For example, the substance in question can? be "surfactant", a phospholipoprotein substance which, how? known, ? deficient in pre-term infants and which is therefore provided to them to prevent the collapse of the pulmonary alveoli, facilitate the recruitment of the airways already? collapse and maintain the capacity? functional residue, with a consequent improvement in oxygenation.

The catheter 8 is then firstly inserted into the tube 2 (for example using one of the two access mouths 11a, the other being used for ventilation), until the distal end portion 8a is brought into proximity. of the extremity? distal 2b of tube 2 (figure 4). The user in this phase can? to note that the distal terminal portion 8a has now reached the extremity? distal 2b observing the images acquired with the video camera 5a, or in any case the electronic vision device 5, whose visual field? facing right (from the inside to the outside of the tube 2) towards the passage opening defined by the end? distal 2b and / or the inner contour of the edge 3a. In fact, the image acquired in this case (and displayed for example on a screen) could be that of figure 9.

It is known that, just to make sure that the totality? of the substance delivered through the catheter 8 invests the lungs,? It is essential to align the distal terminal portion 8a to the larynx E and then introduce the distal terminal portion 8a into the latter by a few millimeters or centimeters, beyond the extremity? distal 2b and the vocal cords.

In fact, in case of non-alignment, by further pushing the catheter 8 the distal terminal portion 8a could impact and abrade the vocal cords or in any case the anatomical tissues of patient A, without reaching the necessary condition. Likewise, should the user "be satisfied" and stop introducing the distal end portion 8a at the end? distal 2b, there would be no complete perfusion of the lungs (the substance could partly end up in the esophagus F or go up towards the oral cavity B).

In this context, therefore, the user can? check the images provided by the device 5 and verify if the distal end portion 8a? actually aligned with the larynx E before pushing the catheter 8 further deeper.

If not, the user can? press the lung 9 or otherwise send air or other fluid along the line 7, inflating (or possibly deflating) the envelope 6 and progressively moving the distal terminal portion 8a (figure 5), lifting it (or possibly lowering it) that is? progressively, by the action of the casing 6 itself. Pi? in detail, by checking the images of the device 5 through the screen (Figure 10), the user inflates the envelope 6 until the distal end portion 8a reaches the desired alignment condition, at which he interrupts the inflation of the casing 6 (keeping the pressure constant on the lung 9 for example) and further pushes the catheter 8, precisely causing the distal end portion 8a to enter the larynx E (Figures 6 and 11) reaching the desired final position.

Is that so? It is possible to insufflate the substance into the lungs through the catheter 8.

The choice of shaping the casing 6 like the humps of a camel allows to optimize the positioning operations: in fact, during the inflation the distal terminal portion 8a automatically settles between the lateral swellings 6a and also when the inflation? completed, the inlet 6b keeps centered and guides the further sliding of the catheter 8.

Yup ? therefore, having seen how the instrument 1 achieves the predetermined purpose: the cooperation between the device 5, housed in the seat 4, and the casing 6 ensures practical modalities. of introduction and positioning of a catheter 8, and of its distal end portion 8a in particular, in a cavity? anatomy of any patient A, and for example along his respiratory tract.

Pi? in detail, the tool 1 allows both practical modalities? ventilation of the lungs that the insufflation of a further substance, avoiding the danger that part of the latter may disperse without reaching the designated objective.

These results are obtained with a simple tool 1, easily achievable with commonly available components. on the market and whose implementation does not involve particular complications, giving the instrument 1 high reliability? of operation and practical modalities? of use. The found, so? conceived,? susceptible of numerous modifications and variations, all of which are within the scope of the inventive concept; moreover, all the details can be replaced by other technically equivalent elements.

In the examples of embodiment illustrated, individual characteristics, reported in relation to specific examples, may actually be? replaced with other different characteristics, existing in other embodiments.

In practice, the materials used, as well as? the dimensions may be any according to the requirements and the state of the art.

Claims (10)

R I V E N D I C A Z I O N I 1. Medical-surgical instrument, comprising: - a main tube (2), which can be inserted in at least one anatomical duct of a patient (A) and has one extremity proximal (2a) and one extremity? distal (2b), - an anatomical mask (3) arranged in correspondence with said extremity distal (2b) and presenting an enlarged peripheral edge (3a), configured for stable support on an anatomical tissue of the patient (A), characterized by the fact of understanding: - a seat (4) configured for housing, even temporarily, an electronic viewing device (5), e - an inflatable casing (6), internally fixed to said tube (2) at said end distal (2b) and associated with a respective swelling line (7). 2. Instrument, according to claim 1, characterized in that it comprises an accessory of the type of a catheter (8), a probe, or the like, which can be removably inserted into said tube (2) at said end. proximal (2a). 3. Instrument, according to claim 1 or 2, characterized in that it comprises said electronic viewing device (5), said device (5) being configured for the acquisition and transmission in real time of images relating to the passing light defined by said end? distal (2b) and / or to said inner contour of said edge (3a). 4. Instrument, according to one or more? of the preceding claims, characterized in that said main tube (2) has a curved longitudinal development, said casing (6) being located in correspondence with the flap of said end. distal (2b) disposed diametrically on the opposite side with respect to the ideal center of curvature of said tube (2). 5. Instrument, according to one or more? of the preceding claims, characterized in that said casing (6) has, at least in an active configuration, obtainable following the swelling operated by means of said line (7), two lateral swellings (6a), side by side along a plane transversal to the longitudinal axis of said tube (2), and a central inlet (6b), interposed between said bulges (6a). 6. Instrument, according to one or more? of the preceding claims, characterized in that at least a fraction of said swelling line (7)? integrated in the thickness of said main tube (2) or? stably applied on the inner side surface or on the outer side surface of said main tube (2). 7. Instrument, according to one or more? of the preceding claims, characterized in that said inflation line (7)? associated, on the opposite side to said envelope (6), to an inflatable lung (9), located externally to said tube (2) and equipped with an inlet (9a), operationally located on the opposite side to said line (7) and equipped a valve for the unidirectional passage of fluid, configured for the selective consent to the filling of said lung (9) and the obstacle to emptying. 8. Instrument, according to one or more? of the preceding claims, characterized in that said seat (4) comprises at least one auxiliary channel, leading to said end? distal (2b) of said tube (2) and having at least one fraction integrated in the thickness of said main tube (2) or stably applied to the external lateral surface or to the internal lateral surface of said main tube (2), for the introduction and the housing, also temporary, of said electronic vision device (5), and / or of a further medical device. 9. Instrument, according to one or more? of the preceding claims, characterized by the fact that said electronic viewing device (5) comprises a video camera (5a), which can at least temporarily be placed in proximity? of said extremity? distal (2b) of said main tube (2), to direct its visual field towards said extremity distal (2b) and / or said internal contour of said edge (3a), said camera (5a) being operatively associable with a screen, for real-time viewing of the acquired images. 10. Instrument, according to one or more? of the previous claims, characterized by the fact that said extremity? proximal (2a) of said main tube (2)? coupled to a "Y" fitting (11), defining two mutually independent access openings (11a) to said main pipe (2).