EP3426192A1

EP3426192A1 - Intra-laryngeal prosthesis comprising a sealing skirt

Info

Publication number: EP3426192A1
Application number: EP17709436.4A
Authority: EP
Inventors: Nicolas Perrin
Original assignee: Protip Medical
Current assignee: Protip Medical
Priority date: 2016-03-10
Filing date: 2017-03-08
Publication date: 2019-01-16
Also published as: FR3048606A1; WO2017153446A1; US20190110892A1; FR3048606B1; US10449038B2

Abstract

The invention relates to an intra-laryngeal prosthesis (PIL) for insertion into a larynx, said prosthesis having an upper portion (PH) comprising: a tubular inner wall (1) with a first end, referred to as upper end (2), and a second end, referred to as lower end (3); a tubular outer wall (4) with a first end, referred to as upper end (2) and a second end, referred to as lower end (3), said outer wall (4) surrounding at least a portion of the inner wall (1); a plurality of ribs (5) extending in the direction of the main axis (X) of the prosthesis and connecting the inner wall (1) with the outer wall (4) such that a plurality of cells (6) are formed between the inner wall (1) and the outer wall (4).

Description

INTRA-LARYNGEAL PROSTHESIS COMPRISING A WATERPROOF SKIRT

TECHNICAL AREA

The present invention relates to an intra-laryngeal prosthesis. More particularly, the invention relates to an intra-laryngeal prosthesis comprising a sealing skirt.

STATE OF THE PRIOR ART

One of the main functions of the larynx is to seal, during swallowing, the lower airways (or respiratory) to protect them and prevent the bolus from entering, instead of passing through the esophagus. This obturation is done by a mechanism of neuromuscular reflex of sequential closure on four floors of the larynx, going from the bottom to the top: vocal folds (glottis), ventricular bands, aryepiglottic folds and epiglottis. In case of dysfunction at one of these stages, it may follow disorders of swallowing, the larynx can no longer ensure proper protection of the lower airways, so that the bolus can pass into them (false roads) when he arrived at the aero-digestive junction.

To remedy this problem, it is known to dispose in the larynx of a patient an intra-laryngeal prosthesis. Such a prosthesis is for example described in WO 2015/032886 which proposes an intra-laryngeal prosthesis configured to be introduced into a larynx, the prosthesis comprising a tubular body having a proximal end surrounding a proximal opening and a distal end surrounding an opening. distal, a valve having a proximal end and a distal end and a hinge connecting the proximal end of the valve to the proximal end of the tubular body so that the valve can be placed in a normal position in which it covers the proximal opening or in an open position in which it does not cover the proximal opening. In this device, the valve is arranged in such a way that, in the normal position, the distal end of the valve forms a rim which covers a part of the tubular body and that a space exists between the distal end of the valve and the tubular body so that air can enter the proximal opening of the tubular body through this space. However, when a prosthesis according to the state of the art is introduced into the larynx of a patient, sealing problems can occur between the prosthesis and the larynx. These problems are mainly due to an inadequacy between the shape of the upper part of the prosthesis and the morphology of the larynx of the patient, the latter may vary from one patient to another. These leakage problems result in a penetration of the bolus or saliva into the lower airways that can cause discomfort or even lower airway infections (pneumonitis inhalation).

There is therefore a need for an intra-laryngeal prosthesis that ensures a good seal between the upper part of the prosthesis and the larynx.

SUMMARY OF THE INVENTION

The invention aims to remedy this technical problem and proposes for this purpose an intra-laryngeal prosthesis comprising an upper part comprising an inner wall and an outer wall connected by a plurality of ribs, this structure forming a sealing skirt permitting adapt the shape of the upper part of the prosthesis to the morphology of the larynx.

To do this, a first aspect of the invention relates to an intralaryngeal prosthesis (ILP) intended to be introduced into a larynx; said prosthesis having an upper portion (PH) comprising:

a tubular inner wall comprising a first end, said upper end, and a second end, said lower end; a tubular outer wall comprising a first end, said upper end and a second end, said lower end; said outer wall surrounding at least a portion of the inner wall; a plurality of ribs extending in the direction of the main axis (X) of the prosthesis and connecting the inner wall to the outer wall forming a plurality of cells between the inner wall (1) and the outer wall.

The upper end is so designated because it is at the top when the prosthesis is placed in situ, that is to say on the side of the throat. The lower end is down, on the side of the trachea. The presence of a lower part is described later, but the prosthesis may not have such a low part.

In a preferred embodiment, the plurality of ribs extending in the direction of the main axis (X) of the prosthesis and connecting the inner wall to the outer wall forming a plurality of cells between the inner wall (1) and the outer wall extends between the upper and lower ends. In another embodiment, this plurality of ribs extends only over a portion of the prosthesis, from the upper end. In another embodiment, the plurality of ribs extends over several portions of the prosthesis, the plurality of rib portions being separated,

or by an outer wall which is not connected to the inner wall by a plurality of ribs

- Or by a "vacuum", that is to say, no outer wall surrounds the inner wall.

These cells can deform (crush) if necessary depending on the anatomy (variable depending on the individual), which allows a good seal. These cells are thus separated by ribs which thus connect the wall of the outer casing to the wall of the inner duct. Particular attention will be paid to the level of the vocal cord zone (glottal plane) which plays an important role in the sealing.

The term tubular is understood as meaning in the form of a tube, that is to say a conduit having a light defined by a wall. This conduit may be cylindrical or not. In a particular embodiment, the tubular inner wall defines a cylindrical lumen.

In a particular embodiment, the tubular outer wall is not cylindrical, but has the smooth shape of the middle larynx, and preferably slightly larger than the average dimension of the laryngeal duct, allowing a slight crushing of the outer casing and thus creating the seal. Indeed, the glottis and the upper larynx are non-cylindrical and more triangular in shape with flattened sides. Therefore, the use of a non-cylindrical outer wall of suitable shape makes it possible to conform to the internal laryngeal contours of the human larynx. US Patent Applications 20050177233 and US 20040019387 describe such suitable forms. The shape of the outer tubular wall may also be designed by successive iterations using superimpositions on 3D reconstructions of laryngeal ducts, derived from CT scan data. In one embodiment, the inner wall and the outer wall meet at their first and / or second ends (3). Particularly preferably, the inner and outer walls meet at their upper ends. In another embodiment, the inner and outer walls meet at their lower ends. In another embodiment, these inner and outer walls meet at their two lower and upper ends.

In a particular embodiment, the prosthesis also comprises a tubular lower part (PB) disposed in the extension of the inner wall of the upper part (PH) of the prosthesis, thus forming a tubular conduit.

To do this, in this embodiment, the invention relates to an intralaryngeal prosthesis for insertion into a larynx; said prosthesis comprising a tubular lower part and an upper part, this upper part comprising:

a tubular inner wall comprising a first end, said upper end, and a second end, said lower end; a tubular outer wall comprising a first end, said upper end and a second end, said lower end; said outer wall surrounding the inner wall; the inner wall and the outer wall joining at their first and second ends;

a plurality of ribs extending in the direction of the main axis of the prosthesis and connecting the inner wall to the outer wall forming a plurality of cells between the inner wall and the outer wall;

the lower tubular portion of the prosthesis being disposed in the extension of the tubular inner wall of the upper part of the prosthesis thereby forming a tubular conduit.

Thus, the prosthesis according to the invention ensures a better seal between the upper part of the prosthesis and the larynx. Indeed, the outer wall adapts to the morphology of the larynx, by deformation. In addition, the presence of ribs and cavities ensures good rigidity to the structure and allows local deformations not to affect the entire upper part of the prosthesis. The tubular duct defines a distal opening in the lower part of the prosthesis and a proximal opening in the upper part of the prosthesis allowing the passage of air to the lower airways.

The intra-laryngeal prosthesis described herein may also have one or more of the following features taken independently or in any technically possible combination.

In a particular embodiment, the upper end of the tubular inner wall is closed. In this embodiment, the prosthesis behaves like a plug which prevents communication between the trachea (located on the side of the lower end of the prosthesis) and the mouth / throat of the patient (located on the side of the upper end of the prosthesis). Thus, the closed end of the prosthesis (which can be dome-shaped) acts as a barrier to prevent food, saliva and other materials from entering the lungs via the trachea, sealing being further ensured by the specific shape of the outer wall and the presence of the cells, to avoid severe false-roads. This prosthesis replaces the current treatment (tracheostomy associated with a balloon cannula), which requires important cannula care (aspirations), especially after each meal.

In this embodiment, a kit containing the prosthesis as described can be envisioned, as well as a substantially L-shaped tracheostomy connector, which has a lumen formed between a proximal end (located "outside the patient" via the tracheostomy port) and a distal end (in the lumen of the prosthesis or opening into the patient's trachea), the distal end being inserted into the prosthesis through the opening mentioned above, and opening towards the end lower part of the lower wall. Such a prosthesis geometry has been described in US 4794924 (see in particular the element 70 of Figure 1 of US 4794924). The embodiments described in US 4794924 (and in particular the presence of an orifice 72 (according to the reference of FIG. 1 of US 4794924), of the band 62) can also be implemented in this embodiment. However, it should be noted that in the event of the presence of a valve such as the valve 50 of US 4794924 on the tracheostomy connector, the upper end of the prosthesis will then preferentially be open (see above). In another embodiment, the upper end of the inner tubular wall is open. In this embodiment, the tubular conduit formed by the inner tubular wall allows communication between the trachea and the mouth / throat. In this embodiment, it is preferred that this open end evening "protected" by a valve, as described below, to prevent the elements entering the mouth from entering the trachea. The existing communication allows the passage of air. In one embodiment, the valve is such that the flow of air is essentially from the trachea to the pharynx. In another embodiment, the valve is such that the flow of air is in both directions (trachea towards pharynx and pharynx towards trachea).

The embodiment using a valve allowing essentially air to pass from the trachea to the throat is generally implemented for patients who would require a laryngeal prosthesis, and to give them the opportunity to speak. These patients could express themselves (with a whispered voice only because the plug is positioned between the vocal cords) while protecting their lower airways.

The present version of this laryngeal plug has at its proximal end a unidirectional valve which has 2 positions:

- A position called "rest": the valve is closed on the body of the prosthesis in a sealed manner (no passage of liquid such as saliva for example).

A so-called "phonation" position: the valve opens upwards when the patient wishes to express himself (generating a pressure). The passage of air through the pharynx and mouth, coupled with the articulation of the tongue and the oral cavity, allows the patient to express himself with a whispered voice.

In this embodiment (open upper end), one can also consider the implementation with the tracheostomy connector as described more top, and a kit including the prosthesis, as well as this connector. In this embodiment, the tracheostomy tube 70 may comprise a unidirectional directional valve that allows air to enter the lungs via tube 70 but does not allow air to exit through tube 70. The air exhaled from the patient's lungs then passes into the prosthesis according to the invention, through the opening located at the upper end. Exhalation through the prosthesis helps purge the lungs and trachea and keep the prosthesis free of mucus. In this embodiment, a valve is preferably placed at the upper end of the prosthesis, which opens upwards (towards the pharynx), under the effect of the pressure exerted by the exhaled air. The presence of the valve allows to keep closed the upper end of the prosthesis in the absence of expiration of the patient, and avoids the entry of undesired material (food bolus, water, saliva ...) in the trachea.

US Patent Application Nos. 20140288648 and 8551168 disclose valve devices. The teaching of these titles, in that it describes the valves and in particular the devices for fixing the valves on the prosthesis is directly applicable to the prosthesis described in the present application. It should be noted, however, that these titles describe double-clamshell systems, whereas the system envisioned in this framework has only one flap.

In another embodiment, a kit comprising a prosthesis as described above, as well as an L-shaped connector, as described in US 4794924, and shown in FIG. 4 of this patent, is contemplated. One end of the T of this connector can be inserted into the lower end of the inner conduit of the prosthesis, the other leg of the T being introduced into the trachea, and the foot of the T passing through the tracheostomy hole.

Once inserted into the larynx, the surface of the outer wall is in contact with the inner surface of the larynx. Thus, it is preferred that this outer surface be smooth to prevent adhesion of dust, mucus or moisture, and to minimize abrasion of the laryngeal mucosa. This surface can be treated by any suitable surface coating. Preferably, the wall of the inner duct is more rigid (generally thicker) than the outer wall. The ribs are enough that can dampen the deformation to avoid transmitting on the opposite rib.

The upper part may have 6 or 8 cells. However, it may have fewer than 6 and more than 8 cells. The angular distribution of these cells may be variable: some areas of the outer envelope of the prosthesis may need to be reinforced with more cells (every 20 ° for example) and vice versa (every 45 ° for example).

The thickness of the outer shell is about 0.4 mm and the ribs are about 0.3 mm. These quantities may change in case of redesign if there is a need to increase or decrease rigidity. It is also envisaged to have ribs of different thicknesses: thicker in front and back and thinner on the sides, or vice versa.

The entire new geometry is designed so that the prosthesis is atraumatic. In particular, all the edges are rounded.

Advantageously, each cell comprises an opening arranged at the lower end of the outer wall of the upper part of the prosthesis. Thus the risk of accumulation of saliva or food bolus in the cells is eliminated. In addition, this allows a manufacture of the device by overmoulding or injection in a single step, the orifices left by the mold used in this overmolding or injection step, when positioned according to the invention, not detrimental to the sealing of the prosthesis. The prosthesis can also be made by any other method, and in particular by 3D printing.

Advantageously, the junction between the outer wall and the inner wall at their lower ends, at the openings of the cells, is via a plurality of anchor strips each terminating in an anchoring zone. and in that each opening is delimited by two anchor strips, the width of the anchor strips increasing away from the anchoring zone. Preferably, each opening has an inverted U-shape. Thus, the risk of irritation or inflammation of the tissues and in particular vocal folds are limited, the contact being made progressively through the anchoring strips whose width increases away from the anchoring zone . Advantageously, the outer wall is of substantially cylindrical shape and has a first protuberance, said protuberance extending over a portion of the diameter and at least a portion of the length of the outer wall.

Preferably, the outer wall has a second protuberance diametrically opposite the first protuberance, said second protuberance extending over a portion of the diameter and at least a portion of the length of the outer wall.

By diametrically opposed is meant that the projection in a plane perpendicular to the main axis of the prosthesis of the second protrusion is diametrically opposed (central symmetry with respect to the projection of the axis) to the projection of the first protuberance in this same plan. In other words, although diametrically opposed, the two protuberances may be located at a different height along the main axis of the prosthesis.

Thus, the shape of the prosthesis and in particular of its upper part conforms to the morphology of the larynx. The presence of these protuberances thus reduces the discomfort felt by the patient while increasing the seal between the prosthesis and the wall of the larynx.

Advantageously, the thickness of the ribs and / or the thickness of the outer wall is between 0.1 mm and 1 mm. Preferably, the thickness of the ribs is substantially equal to 0.3 mm and the thickness of the outer wall is substantially equal to 0.4 mm. A good compromise is thus obtained between the rigidity necessary for good mechanical strength and the flexibility required for the outer wall and the ribs to adapt to the morphology of the larynx.

Advantageously, the proximal opening of the tubular duct is closed by means of a closure face, lateral orifices being able to be arranged on the periphery of the upper part of the prosthesis at the sealing face to ensure the passage of air such as the crenellated orifices described in EP 815 807.

In other embodiments, the proximal opening of the tubular conduit is closed by valves, in particular those described in WO 2013/034858, WO 2009/098408 or WO 2015/032886.

Preferably, the prosthesis according to the invention comprises a valve, the valve comprising:

a first part, said moving part, comprising a proximal end and a distal end;

a second part, said fixed part, having a proximal end, the fixed part being secured to the upper part of the prosthesis;

a hinge connecting the proximal end of the movable portion to the proximal end of the fixed portion so that the movable portion of the valve can be placed in a normal position in which it covers the proximal opening of the tubular conduit or in an open position in which it does not cover the proximal opening of the tubular duct.

Thus the moving part, when in the normal position, provides the protective function preventing the bolus from entering the larynx. In addition, the surgeon can also open the valve to control the airway, for example with an endoscope passing through the prosthesis.

Advantageously, the movable portion of the valve has a curved domed shape and the valve is arranged so that, in the normal position, the distal end of the movable portion of the valve forms a rim with an area of the upper part of the prosthesis and a gap exists between the distal end of the movable portion of the valve and the upper portion of the prosthesis so that air can enter the proximal opening of the tubular conduit through this gap.

Thus, the air circulates through the baffle space formed between the valve and the upper part of the prosthesis. In addition, the fact that the movable part of the valve forms a rim with an area of the upper part of the prosthesis makes it possible to prevent the saliva and the food bowl evacuated from the valve surface are evacuated into the tubular duct. However, to allow air circulation despite everything, the movable portion of the valve is configured so that a space exists between the movable part of the valve, and more precisely between its flange, and the upper part of the prosthesis . The air can therefore enter the tubular duct, through this space, without saliva or food bolus entering the tubular duct due to the rim.

Advantageously, the movable portion of the valve has a lower face, and the hinge is shaped (in particular via a torsion spring exerting a return torque on the valve, or elastically) so that the valve is closed in the normal position when no force greater than a threshold force is exerted on the underside of the valve, and that the movable part of the valve goes to the open position when a force greater than a threshold force is exerted on the lower face of the movable portion of the valve.

Thus, in normal breathing, the valve remains in the normal position and therefore it covers the proximal opening of the tubular conduit so as to protect it. In case of expectoration, the movable part of the valve opens to facilitate the expiration of the patient. This is also the case in case of coughing, sneezing or forced expiration.

In particular, it is possible to provide a movable portion of the off-axis valve with respect to the upper part of the prosthesis so that:

- The distal end of the movable portion of the valve forms a rim which covers an area of the upper part of the prosthesis and that;

a gap exists between the distal end of the movable portion of the valve and the upper portion of the prosthesis so that air can enter the proximal opening of the tubular conduit through this gap.

The movable portion of the valve is preferably off-axis in a direction opposite to that of the hinge.

It is also possible that the movable portion of the valve has transverse dimensions greater than those of the upper part of the prosthesis so that: the distal end of the movable portion of the valve forms a rim which covers an area of the upper part of the prosthesis and that;

Of course, the two previous embodiments can be performed separately or in combination. Advantageously, the valve is made of titanium so as to avoid deformation of the fixed portion of the valve when the hinge deforms or the movable portion of the valve under the effect of the bolus or saliva.

Advantageously, the movable portion of the valve comprises centering means disposed on its lower face, the proximal end of the tubular conduit having complementary centering means, the centering means of the movable portion of the valve being arranged to cooperate with the means. complementary to the tubular duct so as to ensure that the movable portion of the valve returns to the desired position when it moves from the open position to the normal position. For this, the centering means may be formed by a truncated centering cone projecting from the lower face of the movable portion of the valve. The complementary centering means may in this case be formed by a truncated conical orifice formed in a transverse wall of the tubular conduit, the orifice being adapted to receive the centering cone. This technical solution ensures that the movable portion of the valve returns to normal position (closed), the cover between the valve and the titanium body being sized to prevent any body (bolus, saliva, ...) passes in the prosthesis, entering through the sides of the prosthesis, between the valve and the upper part of the prosthesis.

Advantageously, the movable portion of the valve is elliptical so as to better adapt to the patient's anatomy and minimize its bulk compared to the surrounding anatomical structures. Advantageously, the lower part of the prosthesis comprises protruding outer protuberances, for fixing said prosthesis in position inside the larynx by supporting said protrusions against an inner wall of the larynx. Advantageously, the growths are chevron-shaped. These excrescences make it possible to obtain a good support of the prosthesis when the latter is in place in the larynx.

Advantageously, the upper part and the lower part of the prosthesis are made of silicone (in particular of hardness between 40 and 70 shores) and the fixed part of the valve is entirely embedded in the silicone constituting the upper part and the lower part. The fastening of the valve with the upper part is thus ensured.

Advantageously, the first protrusion is diametrically opposite to the hinge of the valve. This configuration makes sure that the protuberance is on the same side as the arytenoid cartilages. In this case, the extent of the first protuberance along the length of the outer wall, that is to say along the main axis of the prosthesis, is chosen so that, when the prosthesis is in the larynx, the first protuberance is next to the arytenoid cartilages. Similarly, the extent of the second protuberance along the length of the outer wall, that is to say along the main axis of the prosthesis, is chosen so that, when the prosthesis is in the larynx, the The second protuberance is at the level of the space just above the anterior commissure of the vocal folds. Preferably, all the materials used to make the intra-laryngeal prosthesis is biocompatible.

BRIEF DESCRIPTION OF THE FIGURES Other characteristics and advantages of the invention will emerge on reading the detailed description which follows, with reference to the appended figures, which illustrate: FIG. 1A, a sectional side view of a prosthesis according to a embodiment of the invention;

- Figure 1 B, a sectional top view of a prosthesis according to one embodiment of the invention; Figure 2 is a side view of a prosthesis according to one embodiment of the invention;

Figure 3, a detailed view of an opening of a cell according to the invention Figure 4, three views of a prosthesis according to one embodiment of the invention, wherein the upper end is closed. Figures 4.A and 4.B show a view from above or below the prosthesis. Figure 4.C shows a sectional view of the prosthesis;

- Figure 5 shows a close view of a valve 14 positioned on the upper end of the prosthesis in the closed position (A) or open (B)

For the sake of clarity, identical or similar elements are identified by identical reference signs throughout the figures.

DETAILED DESCRIPTION OF AT LEAST ONE EMBODIMENT

In a first embodiment illustrated in FIGS. 1A-B and 2, the intra-laryngeal prosthesis PIL according to the invention comprises a tubular lower part PB and a high part PH, the upper part PH comprising:

a tubular inner wall 1 comprising a first end, said upper end 2, and a second end, said lower end

3;

a tubular outer wall 4 comprising a first end, said upper end 2 and a second end, said lower end 3; said outer wall 4 surrounding the inner wall 1; the inner wall 1 and the outer wall 4 joining at their first ends 1 and second ends 3;

a plurality of ribs 5 extending in the direction of the main axis X of the prosthesis and connecting the inner wall 1 to the outer wall 4 forming a plurality of cells 6 between the inner wall 1 and the outer wall 4; the lower part PB of the prosthesis being disposed in the extension of the inner wall 1 of the upper part PH of the prosthesis thus forming a tubular conduit

7.

Thus, the prosthesis PIL according to the invention ensures the seal between the upper part PH of the prosthesis PIL and the larynx, the outer wall 4 adapting by deformation to the morphology of the larynx. In addition, the presence of the ribs 5 and the cells 6 provides good rigidity to the outer wall and allows local deformations not to affect the entire upper part PH of the prosthesis PIL. The tubular duct 7 formed by the lower part PB of the prosthesis PIL and the inner wall 1 of the upper part PH of the prosthesis PIL defines a distal opening 8 in the lower part PB of the prosthesis and a proximal opening in the upper part of the prosthesis. the prosthesis (not shown), opposite to the distal opening 8, allowing air to circulate in the airways.

In the prosthesis according to the invention, it is also possible to modulate the mechanical strength of the outer wall 4 by modifying the thickness of the ribs 5 and / or the thickness of the outer wall 4. In one embodiment, the thickness of the ribs 5 and / or the thickness of the outer wall 4 is between 0.1 mm and 1 mm. Preferably the thickness of the ribs 5 is substantially equal to 0.3 mm and the thickness of the outer wall 4 is substantially equal to 0.4 mm. In one embodiment, the ribs 5 have a different thickness depending on their position. In the embodiment illustrated in FIG. 1B, the ribs 5 are eight in number. However, a different number of ribs can be envisaged. An embodiment may notably be envisaged in which the ribs 5 are three in number. In a preferred embodiment, the ribs 5 are arranged symmetrically with respect to a plane F1 passing through the main axis X of the PIL prosthesis. When the prosthesis is placed in the larynx of a patient, the plane F1 coincides with the sagittal plane.

In one embodiment, each cell 6 comprises an opening 9 arranged at the lower end 3 of the outer wall 4 of the upper part PH of the PIL prosthesis.

Indeed, in the case where the manufacturing technique of the prosthesis PIL according to the invention involves the use of a mold, the latter must be extracted from the part obtained. This extraction is generally by openings, these openings resulting from the shape of the mold used. However, in the PIL prosthesis object of the invention, the arrangement of the openings 9 is important, because an improper disposition of these openings 9 may cause a saliva accumulation or food bolus in the cells 6. By arranging the openings 9 at the lower end 3 1 and outer wall 4, the risk of accumulation of saliva or food bolus in the cells 6 is eliminated, since the elements likely to accumulate in the cells 6 are stopped upstream by the outer wall 4 of the part high PH of the PIL prosthesis. However, the presence of these openings 9 can cause tissue irritation and in particular vocal folds which, when the PIL prosthesis is in place in the larynx, are close to the lower end 3 of the teeth. inner 1 and outer 4 walls of the upper part PH. This is particularly the case if the openings 9 are in the form of crenellations, the edges of the openings then being in the form of very pronounced edges.

In order to limit this risk of irritation, in one embodiment illustrated in FIG. 3, the junction between the outer wall 4 and the inner wall 1 at their lower end 3 is via a plurality of anchoring strips 13 each terminating in an anchoring zone 12 and in that each opening 9 is delimited by two anchor strips 13, the width of the anchoring strips 13 increasing away from the zone of anchorage 12.

This configuration limits tissue damage. Indeed, the flared shape of the anchoring strips 13 ensures a progressive contact and limits tissue irritation at the lower end 3 of the outer wall 4 and the inner wall 1 of the upper part PH. In one embodiment, each aperture 9 has an inverted U-shape. The distance between the inner wall 1 and the outer wall 4 may also vary. In one embodiment, the distance between the outer wall 4 and the inner wall 1 is between 0.5mm and 10mm. One can also choose to modulate the distance between the inner wall 1 and the outer wall 4 to form protuberances. In one embodiment, the outer wall 4 is substantially cylindrical in shape and has a first protuberance 10, said protrusion 10 extending over a portion of the diameter and at least a portion of the length of the outer wall 4 of the upper portion. of the prosthesis.

This protuberance 10 gives the prosthesis PIL a form closer to the morphology of the larynx which reduces the discomfort caused by the prosthesis while increasing the seal between the larynx and the prosthesis PIL. In one embodiment, the shape and location of this first protuberance 10 are chosen so that when the PIL prosthesis is in place in the larynx, the first protuberance 10 is located opposite the upper portion of the arytenoid cartilages.

In one embodiment, there is provided a second protrusion 1 1 diametrically opposed to the first protrusion 10, said second protuberance 11 extending over a portion of the diameter and at least a portion of the length of the outer wall 4 of the upper part of the prosthesis.

By diametrically opposed is meant that the projection in a plane perpendicular to the main axis X of the prosthesis PIL of the second protuberance 11 is diametrically opposite, relative to the diameter of the tubular conduit 7, the projection of the first protrusion 10 in this same plan. In other words, although diametrically opposed, the two protuberances 10, 1 1 may be located at a different height along the main axis X of the prosthesis PIL.

Like the first protuberance 10, this second protuberance January 1 gives the prosthesis PIL a form closer to the morphology of the larynx which reduces the inconvenience caused by the prosthesis PIL while increasing the seal between the larynx and the prosthesis PIL . In one embodiment, the shape and location of this second protuberance 11 are chosen so that when the prosthesis PIL is in the larynx, the second protuberance 11 is located in the space just above of the anterior commissure of the vocal folds.

The adaptation of the protuberances to the morphology of the larynx is further improved by the presence of the ribs 5 and the cells 6 which allows the deformation localized these protuberances 10.1 1 and provides a good adaptation of the prosthesis PIL while minimizing the discomfort felt by the patient.

In a preferred embodiment, the first protuberance 10 and the second protuberance 11 are chosen so as to have the same plane of symmetry as the larynx when the prosthesis is in place in said larynx. In other words, once in the larynx, the sagittal plane is a plane of symmetry of the first protuberance 10 and the second protuberance 11. In one embodiment, the ribs 5 are arranged symmetrically with respect to the plane of symmetry of the first protuberance 10 and the second protuberance 11.

In one embodiment, the lower portion PB of the prosthesis PIL comprises protruding external protrusions 19, for fixing said PIL prosthesis in position inside the larynx by supporting said protrusions 19 against an inner wall of the larynx. Advantageously, the protrusions 19 are chevron-shaped. These protuberances 19 make it possible to obtain good retention of the PIL prosthesis when the latter is in place in the larynx.

In one embodiment, the prosthesis comprises a valve 17, the valve 17 comprising:

a first portion, said moving portion 14, having a proximal end and a distal end;

a second part, said fixed part 15, having a proximal end, the fixed part 15 being integral with the upper part PH;

a hinge 16 connecting the proximal end of the mobile part 14 to the proximal end of the fixed part 15 so that the mobile part 14 of the valve can be placed in a normal position in which it covers the proximal opening tubular duct 7 or in an open position in which it does not cover the proximal opening of the tubular duct 7.

In one embodiment, the movable portion 14 of the valve 17 has a domed domed shape and in that the valve 17 is arranged so that, in the normal position, the distal end of the movable portion 14 of the valve 17 forms a flange 18 with an area of the upper PH portion of the PIL prosthesis and that a space exists between the distal end of the movable portion 14 of the valve and the upper part PH of the prosthesis PIL so that air can enter the proximal opening of the tubular conduit 7 by this space. Thus, the fact that the movable portion of the valve 17 forms a flange which covers a portion of the tubular conduit 7 prevents the saliva and the food bolus discharged from the surface of the movable portion of the valve 17 are evacuated in the conduit tubular 7 and therefore in the lower airways. However, to allow air circulation despite everything, the movable portion of the valve 17 is configured so that a space exists between the movable portion of the valve 17, and more precisely between its flange 18, and the upper part PH of the PIL prosthesis. The air can therefore enter the tubular duct 7 through this space, without the saliva or food bolus entering the tubular duct due to the flange 18.

FIG. 4 represents an intra-laryngeal prosthesis PIL according to another embodiment of the invention comprising a high part PH, the high part PH comprising:

a tubular inner wall 1;

a tubular outer wall 4; said outer wall 4 surrounding the inner wall 1;

a plurality of ribs 5 extending in the direction of the main axis X of the prosthesis and connecting the inner wall 1 to the outer wall 4 forming a plurality of cells 6 between the inner wall 1 and the outer wall 4. The Figure 5 shows the movement of the movable portion 14 of a valve, used to allow the patient to be able to speak with a whispered voice. The valve rises (arrow) under the effect of pressure exerted by the patient, the tracheostomy hole then being blocked by the patient.

Claims

Intra-laryngeal prosthesis (ILP) intended to be introduced into a larynx; said prosthesis having an upper portion (PH) comprising:

- an inner tubular wall (1) comprising a first end, said upper end (2), and a second end, said lower end (3);

- A tubular outer wall (4) comprising a first end, said upper end (2) and a second end, said lower end (3); said outer wall (4) surrounding at least a portion of the inner wall (1);

a plurality of ribs (5) extending in the direction of the main axis (X) of the prosthesis and connecting the inner wall (1) to the outer wall (4) forming a plurality of cells (6) between the inner wall (1) and the outer wall (4).

Intra-laryngeal prosthesis according to claim 1, characterized in that it also comprises a tubular lower part (PB) disposed in the extension of the inner wall (1) of the upper part (PH) of the prosthesis, thus forming a tubular duct.

Intra-laryngeal prosthesis according to claim 1 or 2, characterized in that the upper end (2) is closed.

Intra-laryngeal prosthesis according to claim 1 or 2, characterized in that the upper end (2) is open.

Intra-laryngeal prosthesis according to claim 3, characterized in that the prosthesis has a tubular lower part, arranged in the extension of the inner wall (1) of the upper part (PH) of the prosthesis, said tubular part having a localized opening so that it is aligned with the tracheostomy hole after implanting the prosthesis into the larynx. Intra-laryngeal prosthesis according to claim 1, characterized in that each cell (6) comprises an opening (9) arranged at the lower end (3) of the outer wall (4) of the upper part (PH) of the prosthesis.

Intra-laryngeal prosthesis according to claim 2, characterized in that the junction between the outer wall (4) and the inner wall (1) at their lower end (3) is via a plurality of bands anchoring means (13) each terminating in an anchoring zone (12) and in that each opening (9) is delimited by two anchoring zones (13), the width of the anchoring strips (13) increasing away from the anchoring zone (12).

Intra-laryngeal prosthesis according to claim 3, characterized in that each opening (9) has an inverted U-shape.

Intra-laryngeal prosthesis according to one of claims 1 to 4, characterized in that the outer wall (4) is substantially cylindrical in shape and has a first protuberance (10), said protuberance (10) extending over a portion of the diameter and at least a portion of the length of the outer wall (4).

Intra-laryngeal prosthesis according to claim 5, characterized in that the outer wall has a second protrusion (1 1) diametrically opposite the first protuberance (10), said second protuberance (1 1) extending over a portion of the diameter and at least a part of the length of the outer wall (4).

Intra-laryngeal prosthesis according to one of claims 1 to 6, characterized in that the thickness of the ribs (5) and / or the thickness of the outer wall (4) is between 0.1 mm and 1 mm, preferably the thickness of the ribs is substantially equal to 0.3 mm and the thickness of the outer wall is substantially equal to 0.4 mm. Intra-laryngeal prosthesis (ILP) according to one of claims 1 to 7, characterized in that the tubular duct (7) defines a proximal opening in the upper part (PH) of the prosthesis (PIL) and in that said prosthesis (PIL) comprises a valve (17), the valve (17) comprising:

- a first part, said moving part (14), having a proximal end and a distal end;

- A second part, said fixed part (15), having a proximal end, the fixed part (15) being secured to the upper part (PH);

- a hinge (16) connecting the proximal end of the movable portion (14) to the proximal end of the fixed portion (15) so that the movable portion (14) of the valve can be placed in a normal position in which it covers the proximal opening of the tubular duct (7) or in an open position in which it does not cover the proximal opening of the tubular duct (7).

Intra-laryngeal prosthesis according to claim 8, characterized in that the movable portion (14) of the valve has a curved domed shape and in that the valve is arranged so that in normal position the distal end of the movable part (14) of the flap forms a flange (18) with an area of the upper part (PH) and a gap exists between the distal end of the movable portion (14) of the flap and the upper portion (PH) so that air can enter the proximal opening of the tubular duct (7) through this space.

Intra-laryngeal prosthesis according to one of claims 8 or 9 in their dependence on claim 5 or claim 6, characterized in that the first protrusion (10) is diametrically opposed to the hinge (16) of the valve.

Intra-laryngeal prosthesis according to one of claims 1 to 14, characterized in that the outer surface of the tubular outer wall (4) is smooth and / or covered with a surface coating preventing adhesion of dust, mucous or moisture.