FR3160877A1 - Single-use protective device of the tab type intended to be positioned removably on an upper face of an intubation blade - Google Patents

Abstract

The present invention relates to a single-use protective device (200) intended to be positioned removably on an upper face (133) of an intubation blade (1) to come into contact in particular with the upper incisors (I) of a patient during intubation, said protective device (200) comprising an elongated tongue (201) whose internal face (201a) is configured to match the shape of the upper face (133) of said blade (1) and whose external face (201b) intended to be in contact with the incisors (I) of said patient is made of a shock-absorbing material, so that, during intubation, the protective device (200) at least partially covers the upper face (133) of the blade (1) and constitutes a shock absorber between the blade (1) and the upper incisors (I) of the patient. Figure 4

Description

Single-use protective device of the tab type intended to be positioned removably on an upper face of an intubation blade

The present invention relates to the field of health and relates more particularly to a removable single-use tab intended to be positioned on an intubation blade in order to prevent dental breakage.

Prior art

Intubation is a medical procedure that involves inserting an intubation tube into a patient's trachea. Inserting this tube allows both mechanical ventilation and the administration of medication through the lungs.

Intubation is most often performed during a surgical procedure that requires the patient to be under general anesthesia.

To insert the aforementioned tube into the trachea, the tracheal orifice must be visualized. To do this, an exploration of the back of the throat and larynx (laryngoscopy) is performed through the mouth using an intubation device.

This intubation device has a handle at the end of which is mounted an intubation blade.

The blade typically includes a tongue depressor sole and a protruding portion that extends perpendicular to the sole and is primarily used to:
- lift the tongue and lower jaw; and
- visualize the tracheal orifice.

The blade is equipped with a light guide such as, for example, an optical fiber, one end of which is arranged substantially at the end of the blade.

The handle has a lamp that generates light when the intubation blade is mounted on the handle.

During intubation, the blade is inserted into the patient's mouth: the sole presses on the patient's tongue and the protruding portion spreads the lingual mass and the lower jaw.

The blade's light guide then allows, by transmitting the light emitted by the handle, to illuminate the opening of the trachea. The practitioner can thus, by sliding the intubation tube over the blade, visualize the trachea and position it correctly in the patient's body.

During this procedure, the teeth, and in particular the patient's incisors, are likely to come into contact with the upper surface of the protruding portion. This is especially likely when, for example, the patient has a narrower than normal mouth or has a pathology limiting their mouth opening.

The mobilization and pressure of the blade on the teeth (healthy or in poor condition or in perfect rehabilitation) sometimes causes the incisors to break, or even to be extracted, depending on the state of the patient's teeth.

While some dental expulsions are unavoidable due to the poor oral health of some patients, others suffer fractures, cracks, chips of enamel (or ceramic for prosthetic crowns) on healthy teeth or teeth in perfect rehabilitation.

The Applicant observes here that the financial stakes for professional insurance may prove significant because these dental breakages represent approximately 40% of complaints against anesthesiologists and resuscitators.

To avoid damaging the patient's teeth during laryngoscopy, practitioners are recommended to use dental guards that form splints.

Such gutters made of flexible material are described in the article entitled "How to handle a perianesthetic dental breakage" published in the journal "The practitioner in anesthesia and resuscitation", Editions Elsevier Masson, pages 303-308 volume 17, December 2013.

Using these gutters is not easy.

In particular, these gutters must be adapted to the morphology of the patient's mouth by deformation. The gutters tend to fall and above all their volume considerably hinders the vision that the practitioner can have of the inside of the patient's mouth.

Furthermore, documents US 2005/0240081 A1 and US 2014/0228645 A1 each describe a laryngoscope which comprises a removable handle capable of being mounted on an intubation blade, which comprises a tongue depressor sole, a projecting portion which extends above said sole and a fixing element capable of cooperating with a handle and arranged under said sole. The projecting portion of the intubation blade has an upper face which comprises a damping portion capable of coming into contact with the teeth of the intubated subject.

WO 95/14426 A1 describes a laryngoscope comprising a handle and a removable blade. The blade comprises a tongue-depressor base and a protruding portion whose upper surface is coated with a deformable material such as beeswax. This device helps protect the teeth of the intubated patient.

Document WO2016151241 is also known, which proposes a solution aimed at limiting, or even eliminating, the risk of damaging the teeth of the intubated patient due to an impact with the rear part of the protruding portion.

Document WO2016151241 proposes for this purpose an intubation device comprising an intubation blade which conventionally comprises:
- a tongue depressor sole;
- a projecting portion which extends above the sole and which has an upper face which includes a cushioning portion capable of coming into contact in particular with the patient's upper incisors during intubation, said cushioning portion having a hardness lower than that of said sole and/or the rest of said upper face.

The Applicant submits that the solution proposed in this document WO2016151241 requires a modification of the intubation blade itself.

Indeed, in document WO2016151241, the upper face of the protruding portion includes this damping portion, which generates numerous technical manufacturing constraints and makes the industrialization of this solution very costly:

Document WO2016151241 provides that the damping portion comprises a silicone pad, bonded in a cavity provided or formed by the upper face of the blade. The pad has a shape such that its upper surface complements the upper face of the blade.

All of the above documents address the problem of damage to the patient's teeth due to impact with the upper surface of the protruding portion of the blade.

However, the Applicant submits that the various solutions of the prior art are not satisfactory.

Indeed, to date, neither manufacturers nor practitioners have adopted the solutions proposed in this document, both for reasons of manufacturing complexity and practical reasons regarding the use of the proposed devices.

The present invention aims to improve the situation described above.

One of the objectives of the present invention is to propose an intubation device which makes it possible to reduce or even eliminate the risks of dental breakage during intubation.

One of the other objectives of the present invention is to propose a device which makes it possible to reduce tooth breakage, particularly of the incisors, and which does not obstruct the practitioner's vision during laryngoscopy.

One of the other objectives of the present invention is to offer the practitioner a device that is easy and quick to use and which does not change his operating habits in any way.

Finally, one of the other objectives of the present invention is to offer the practitioner a solution which adapts to the morphology and/or pathologies of the patient.

The present invention aims in particular to remedy at least one of the various technical problems mentioned above by proposing, according to a first aspect, a single-use protection device which is intended to be positioned removably on an upper face of an intubation blade.

Such a device according to the present invention makes it possible to come into contact in particular with the upper incisors of a patient during intubation.

According to the present invention, the protection device comprises an elongated tab:
- the internal face of which is configured to fit the shape of said blade; and
- whose external face, intended to be in contact with the patient's upper incisors, is made of a shock-absorbing material,
Thus, during intubation, the protective device at least partially covers the upper face of the blade and constitutes a shock absorber between the blade and the patient's upper incisors.

It should be noted here that the tab can be sized to extend over all or part of the upper face of the blade. It can extend, for example, over a length substantially equal to or less than half the length of the upper face, or over a length of the order of 3 or 4 cm.

Such a length allows when the tongue tends to adhere to the surface of the tongue not to hinder the sliding of the blade.

It should also be noted that the positioning of the tab on the blade for intubation will create a local excess thickness compared to the rest of the surface of the upper face. This local excess thickness does not obstruct the visibility of the trachea during intubation.

In an advantageous embodiment, the tab is of the strip type.

In another advantageous embodiment, the tongue is of the gutter type and has a substantially U-shaped cross-section over its entire length.

Preferably, in this other mode, it is possible to provide that the branches of the U are curved so as to bear on the lateral facets of the blade and form slides promoting engagement of the tongue on the blade.

It should be noted here that the internal face of the base of the U fits the upper face of the blade and that the branches of the U serve as fixing tabs.

Optionally, the slides are provided at the distal end of the tongue with beads serving here as stops delimiting the end of travel of the tongue on the blade during said engagement.

Here, we understand that the distal end of the tongue comes plumb with the rear part of the blade when it is engaged.

In an advantageous embodiment, the tongue is made of an elastically deformable material so that the branches of the U exert pressure on lateral facets of said blade in order to ensure assembly by pinching the gutter on the blade.

In an embodiment which can possibly be combined with the previous embodiment, the internal face of the tab is provided with adhesive means ensuring assembly by gluing the tab to the blade.

Preferably, the internal face of the tab comprises over all or part of its length an adhesive strip (serving as adhesive means).

Advantageously, the device according to the present invention is made of a damping material having a hardness coefficient lower than that of the upper face of the blade.

The lesser hardness of the cushioning portion prevents teeth from being broken, particularly the patient's incisors, when inserting and/or removing the blade. A person skilled in the art is able to determine the hardness of the cushioning portion, which prevents them from being broken and/or displaced.

Advantageously, the device according to the present invention is made at least partially from a physiologically acceptable flexible material of the elastomer type such as, for example, silicone or polyethylene.

Advantageously, the tongue is curved in order to follow the curvature of the blade.

Preferably, the device according to the present invention is a single-piece part obtained by injection.

Correlatively, the subject of the invention relates, according to a second aspect, to a kit comprising:
- an intubation device with an intubation blade mounted on a handle; and
- a plurality of protective devices as described above.

Advantageously, the protective devices in the kit come in various sizes adapted to the morphology of several types of patients, for example a tab adapted for children, a tab adapted for adults.

Thus, through its various functional and structural technical characteristics described above, practitioners who intervene during an intubation have a single-use accessory, simple and easy to use, which is removably attached to the blade and which adapts to the patient's morphology.

DEFINITIONS

The term " hardness " is not limited to a specific standard. The skilled person can choose, depending on the materials used, the appropriate hardness scale for both materials or different scales that can allow comparison of hardnesses. Thus, it is possible to use Shore hardness for the removable tab used as a shock absorber. As a guide, this tab may have a Shore A hardness according to ISO 868 of between 20 and 60 Shore A.

The term “ elastomer ” designates, within the meaning of the present invention, any elastically deformable polymer.

The term " silicone " means any polymer containing a polysiloxane and any polysiloxane.

The term " physiologically acceptable material " means any material suitable for introduction at least temporarily into the human body, in contact with tissues without causing an immune reaction of such magnitude that it would require the removal of the material before the end of its useful life.

The term " local extra thickness " refers to the surface of the tongue located locally above the surface of the upper face in particular.

Description of figures

Other characteristics and advantages of the present invention will emerge from the description below, with reference to the appended figures which illustrate an exemplary embodiment without any limiting character and in which:

FIG. 1 represents a schematic perspective view from above of a removable blade protection device in the form of a gutter according to an exemplary embodiment of the present invention;

FIG. 2 represents a schematic perspective view from below of a removable protective device conforming to the FIG. 1 ;

FIG. 3 represents an exploded schematic perspective view of an intubation blade equipped with a removable protection device according to an exemplary embodiment of the present invention;

FIG. 4 represents a rear view of the intubation blade in accordance with the FIG. 3 equipped with a removable protective device in accordance with figures 1 and 2;

FIG. 5 represents a schematic view of an intubation blade equipped with a removable protective device in the form of a strip according to an alternative embodiment;

FIG. 6 represents a schematic view of the intubation of a patient using an intubation device comprising an intubation blade conforming to the FIG. 3 equipped with a removable protective device.

Detailed description

A protective device for an intubation blade according to an exemplary embodiment of the present invention will now be described in the following with reference to Figures 1 to 6.

As a reminder, one of the objectives of the present invention is to provide practitioners in charge of laryngoscopy with a simple to manufacture, easy to use tool which does not modify the practices and gestures of the practitioner and which makes it possible to reduce or even eliminate the risks of dental breakage during intubation.

This is made possible in the following example.

To perform a laryngoscopy (see FIG. 6 ), the practitioner is conventionally equipped with an intubation device comprising an intubation blade 1 which has a tongue depressor sole 11 which is curved and has an upper face 110 which is convex.

In this example and as illustrated in figures 3, 4 and 5, the blade 1 further comprises a projecting portion 13 which vertically extends the tongue depressor sole 11.

In this example, the projecting portion 13 has a vertical face 130 in which an opening is formed, and an upper face 133 substantially parallel to the upper face 110 of the sole 11.

In this example, the blade 1 comprises a fixing element 15 which is capable of cooperating by fitting with a handle 2 which is shown here in the FIG. 6 .

The upper face 133 has a first end 135 arranged directly above the fixing element 15 and a second end 137 which corresponds to its junction with the tongue depressor sole 11.

The upper face 133 of the projecting portion 13 forms a curved, convex surface without a bump. In other words, the intersection of the upper face 133 with a vertical plane forms a convex curve having a single maximum which is located between the intersection of the ends of the upper face 133 with the aforementioned vertical plane. The upper face 133 being curved, the thickness of the blade 1, formed by the projecting portion 13, varies in an increasing manner from the second end 137 to its first end 135.

In reference to the FIG. 3 , the blade 1 also comprises an optical fiber 3 forming a light guide, one end of which is arranged at the level of the fixing element 15 and the other, referenced 31 on the FIG. 3 , is arranged in the opening made in the vertical face 130 of the projecting portion 13. The optical fiber 3 is blocked in the aforementioned opening and runs along the blade 1 under the upper face 133.

The usual use of such a blade 1 for intubation is problematic as explained in the preamble.

In fact, we often observe when introducing the blade the breaking of the teeth, in particular the incisors, with the impact of the upper face 133 with the teeth.

The solution proposed in document WO2016151241 is already known.

However, such a solution remains impossible to implement industrially. It requires, in particular, the removal of all molds, which makes the manufacture of such a product impossible.

Also, the present invention makes it possible to design a simple and easy-to-use accessory which meets all of the above problems and the requirements of practitioners.

More particularly, according to the example described in figures 1 and 2, the design of an injected part serving as a single-use protection device 200 is provided, which is intended to be positioned removably on an upper face 133 of the intubation blade 1 to come into contact in particular with the upper incisors of a patient during intubation.

In this example, and as illustrated in these figures 1 and 2, said protective device 200 comprises an elongated tongue 201 in the form of a gutter, the internal face 201a of which is configured to match the shape of said blade 1 and the external face 201b of which intended to be in contact with the incisors I of the patient is made of a shock-absorbing material.

Thanks to this innovation, the tab 201 during intubation at least partially covers the upper face 133 of the blade 1 and acts as a shock absorber between the blade 1 and the upper incisors I of the patient as shown in FIG. 6 .

The practitioner simply needs to take the tab 201 and position the internal face 201a of this tab 201 on the upper face 133 of the blade 1.

It should be noted here that there may be several sizes of tabs 201 in order to meet the different patient morphologies (adult man, adult woman, child, etc.).

This removable tab 201 is characteristic of the present invention.

In the example of figures 1 and 2, this tongue 201 is in the form of a gutter; it has a substantially U-shaped cross section over its entire length.

We could also speak of a hollow cylinder split along its entire length.

In the example of realization of the FIG. 5 , this tab 201 can take the form of a strip which would cover the upper face 133 of the blade 1.

This alternative is even simpler to achieve.

In either case, this tab 201 is made of a damping material having a hardness coefficient lower than that of the upper face 133 of the blade 1.

In the embodiment of figures 1 and 2 (gutter shape), the branches 204 of the U are slightly curved so as to be able to rest on the lateral facets of the blade 1.

This U-shape with curved branches 204 makes it possible to form slides facilitating the engagement of the tongue 201 on the upper face 133 from the second end 137 to its first end 135.

The practitioner simply has to slide the tab 201 by engaging it along these slides along the blade 1 to ensure the assembly of the two elements together.

In an embodiment not illustrated here, it will be possible to provide ridges at the end 202 of the slides; such ridges serve as stops to delimit the end of travel of the tongue 201 on the blade 1 during this engagement.

The assembly of the tab 201 on the blade 1 is facilitated by the design of a tab made of an elastically deformable material.

Thus, the branches 204 of the U of the tongue will deform slightly when the tongue is inserted along the blade and will exert pressure on the lateral facets of the blade in order to ensure assembly by pinching of the tongue 201 on the blade 1.

Alternatively or additionally, it is possible to provide adhesive means on the internal face 201a of the tongue 201 (for example an adhesive strip 205 extending over all or part of the length of the bottom 203 of the gutter) to ensure assembly by gluing of the tongue 201 on the blade 1.

In the example of the FIG. 5 , it is understood here that, when the tab 201 takes the form of a strip, the presence of this adhesive strip 205 on the internal face 201a of the tab 201 is desired to facilitate the assembly by gluing of the tab 201 on the blade 1.

In the example described here and illustrated in Figures 1 to 6, the tongue 201 extends along the upper face of the blade 1 over a distance of the order of 3 cm from its first end 135.

In the embodiment described here, it is planned to produce the tab 201 in a physiologically acceptable flexible material of the elastomer type such as for example silicone or polyethylene.

Advantageously, as illustrated in Figures 3 to 6, the tab 201 is curved in order to follow the curvature of the blade 1.

In reference to the FIG. 6 , an example of use of the invention will now be described. The practitioner selects a single-use tab 201 adapted to the morphology of his patient. He positions this shock-absorbing tab 201 on the upper face of the blade 1 by sliding it in translation along the blade 1.

This blade 1 is mounted on the handle 2 at the level of the fixing element 15.

Blade 1 is approximately perpendicular to handle 2.

The practitioner inserts the tongue depressor sole 11 into the mouth of the sleeping patient. The concave underside of the sole 11 comes into contact with the patient's tongue. The practitioner continues to insert the blade 1 into the patient's mouth by sliding the blade 1 along the patient's tongue; the blade 1 being made of metal, sliding is easy. In doing so, the projecting portion 13 which has an increasing height towards its first end 135 comes into contact with the patient's incisors I, at the level of the shock-absorbing tab 201. This tab 201 being made of elastically deformable elastomer, it deforms upon contact with the incisors, without breaking or moving them, when inserting the blade 1.

In the same way, when removing the blade 1, the shock-absorbing tab 201 prevents, as during introduction, the breaking of the teeth, in particular the incisors.

The present invention thus proposes a single-use protective device comprising a removable tab made of a flexible material capable of being positioned on the upper part of the blade (possible support zone on teeth at risk) made of flexible material (silicone type, polyethylene, etc.).

Such a tab can, for example, take the form of a gutter formed by a hollow cylinder split in the middle which is applied by sliding onto the most protruding upper part of the blade.

It is understood here that this removable tab can be held either by its simple shape (preformed U-shaped strip) or by adhesive means on its internal part.

Such a tab can also be in the form of a strip simply covering the upper face of the blade.

The design of such a flexible removable tongue acts as a shock absorber and allows for more flexible support on the tooth and limits the risk of tooth breakage.

The dimensions of this tab are preferably of different sizes and adaptable according to the size of the blade used by the practitioner.

Finally, to make the practitioner's work easier, predefined markings can be provided on the tab to indicate where to place this tab on the blade.

It should be noted that this detailed description relates to a particular embodiment of the present invention, but that in no case does this description have any limiting character with respect to the subject of the invention; on the contrary, its objective is to remove any possible imprecision or misinterpretation of the claims which follow.

It should also be noted that the reference signs placed in parentheses in the following claims are in no way limiting; these signs have the sole purpose of improving the intelligibility and understanding of the following claims as well as the scope of the protection sought.

Claims (13)

Single-use protective device (200) intended to be positioned removably on an upper face (133) of an intubation blade (1) to come into contact in particular with the upper incisors (I) of a patient during intubation,
said protective device (200) comprising an elongated tongue (201) whose internal face (201a) is configured to match the shape of the upper face (133) of said blade (1) and whose external face (201b) intended to be in contact with the upper incisors (I) of said patient is made of a shock-absorbing material,
such that, during intubation, the protective device (200) at least partially covers the upper face (133) of the blade (1) and constitutes a shock absorber between the blade (1) and the upper incisors (I) of the patient. Device (200) according to claim 1, wherein the tab (201) is of the strip type. Device (200) according to claim 1, in which the tongue (201) is of the gutter type and has over its entire length a substantially U-shaped cross-section. Device (200) according to claim 3, in which the branches (204) of the U are curved so as to bear on the lateral facets of said blade (1) and form slides promoting engagement of the tongue (201) on the blade (1). Device (200) according to claim 4, in which the slides are provided at the distal end (202) of the tongue (201) with beads serving as stops to delimit the end of travel of the tongue (201) along the blade (1) during said engagement. Device (200) according to any one of claims 3 to 5, in which the tongue (201) is made of an elastically deformable material so that the branches (204) of the U exert pressure on lateral facets of said blade (1) in order to ensure assembly by pinching the tongue (201) on the blade (1). Device (200) according to any one of the preceding claims, in which the internal face (201a) of the tab (201) is provided with adhesive means ensuring assembly by gluing the tab (201) onto the blade (1). Device (200) according to claim 7, in which the internal face (201a) of the tab (201) comprises over all or part of its length an adhesive strip (205). Device (200) according to any one of the preceding claims, is made of a damping material having a hardness coefficient lower than that of the upper face (133) of the blade (1). Device (200) according to any one of the preceding claims, which is made at least partially from a physiologically acceptable flexible material of the elastomer type such as for example of the silicone or polyethylene type. Device (200) according to any one of the preceding claims, in which the tab (201) is curved in order to follow the curvature of the blade (1). Kit comprising an intubation blade (1) and a plurality of protective devices (200) according to any one of claims 1 to 11. Kit according to claim 12, wherein the protective devices (200) have various sizes adapted to the morphology of several types of patients.