Intra-laryngeal prosthesis comprising a sealing skirt

Abstract

The invention relates to an intra-laryngeal prosthesis (PIL) for insertion into a larynx, said prosthesis PIL 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).

Claims

1. An intralaryngeal prosthesis (ILP) intended to be introduced into a larynx; said prosthesis having an upper part (UP) comprising: a tubular inner wall (1) comprising a first end, called upper end (2), and a second end, called lower end (3); a tubular outer wall (4) comprising a first end, called upper end (2) and a second end, called lower end (3), said outer wall (4) surrounding at least a portion of the inner wall (1); a plurality of ribs (5) extending along 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).

2. The intralaryngeal prosthesis of claim 1, which also comprises a tubular lower part (LP), positioned in the extension of the inner wall (1) of the upper part (UP) of the prosthesis, thus forming a tubular conduit (7).

3. The intralaryngeal prosthesis of claim 1, wherein the upper end (2) is closed.

4. The intralaryngeal prosthesis of claim 1, wherein the upper end (2) is open.

5. The intralaryngeal prosthesis of claim 3, wherein the prosthesis has a tubular lower part, positioned in the extension of the inner wall (1) of the upper part (UP) of the prosthesis, and said tubular part has an opening located that it is aligned with the tracheotomy opening after implantation of the prosthesis in the larynx.

6. The intralaryngeal prosthesis of claim 1, wherein each cell (6) comprises an opening (9) arranged in the lower end (3) of the outer wall (4) of the upper part (UP) of the prosthesis.

7. The intralaryngeal prosthesis of claim 2, wherein the junction between the outer wall (4) and the inner wall (1) at their lower end (3) is made by means of a plurality of anchoring strips (13) each terminating by an anchoring area (12) and in that each opening (9) is delimited by two anchoring zones (13), the width of the anchoring strips (13) increasing further from the anchoring area (12).

8. The intralaryngeal prosthesis of claim 3, wherein each opening (9) has the shape of an inverted U.

9. The intralaryngeal prosthesis of claim 1, wherein the outer wall (4) is essentially cylindrical and has a first protrusion (10), said protrusion (10) extending over a part of the diameter and at least a part of the length of the outer wall (4).

10. The intralaryngeal prosthesis of claim 9, wherein the outer wall has a second protrusion (11) diametrically opposed to the first protrusion (10), said second protrusion (11) extending over a part of the diameter and at least a part of the length of the outer wall (4).

11. The intralaryngeal prosthesis of claim 1, wherein the thickness of the ribs (5) and/or the thickness of the outer wall (4) is comprised between 0.1 mm and 1 mm, preferably the rib thickness is essentially equal to 0.3 mm and the outer wall thickness is essentially equal to 0.4 mm.

12. The intralaryngeal prosthesis (ILP) of claim 2, wherein the tubular conduit (7) defines a proximal opening in the upper part (UP) of the prosthesis (ILP) and in that said prosthesis (ILP) comprises a valve (17), the valve (17) having: a first part, called movable part (14), having a proximal end and a distal end; a second part, called fixed part (15), having a proximal end, the fixed part (15) being integral with the upper part (UP); a hinge (16) connecting the proximal end of the movable part (14) to the proximal end of the fixed part (15) so that the movable part of the valve (14) can be placed in a normal position in which it covers the proximal opening of the tubular conduit (7) or in an open position in which it does not cover the proximal opening of the tubular conduit (7).

13. The intralaryngeal prosthesis of claim 12, wherein the movable part (14) of the valve has a convex dome shape and the valve is arranged so that, in the normal position, the distal end of the movable part (14) of the valve forms a rim (18) with an area of the upper part (UP) and that a space exists between the distal end of the movable part (14) of the valve and the upper part (UP) so that air can enter the proximal opening of the tubular conduit (7) by this space.

14. The intralaryngeal prosthesis of claim 12, wherein the outer wall (4) is essentially cylindrical and has a first protrusion (10), said protrusion (10) extending over a part of the diameter and at least a part of the length of the outer wall (4) and the first protrusion (10) is diametrically opposed to the hinge (16) of the valve.

15. The intralaryngeal prosthesis of claim 1, wherein the outer surface of the tubular outer wall (4) is smooth and/or covered with a surface coating preventing the adhesion of dust, mucus or moisture.

16. A method for treating a patient in need thereof, comprising the step of implanting the intralaryngeal prosthesis of claim 1 in the larynx of the patient.

17. A method for treating a patient in need thereof, comprising the step of implanting the intralaryngeal prosthesis of claim 2 in the larynx of the patient.

18. A method for treating a patient in need thereof, comprising the step of implanting the intralaryngeal prosthesis of claim 12 in the larynx of the patient.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) Other characteristics and advantages of the invention will result from reading the detailed description that follows, in reference to the attached figures, which illustrate:

(2) FIG. 1A, a side view in section of a prosthesis according to one embodiment of the invention;

(3) FIG. 1B, a top view in section of a prosthesis according to one embodiment of the invention;

(4) FIG. 2, a side view of a prosthesis according to one embodiment of the invention;

(5) FIG. 3, a detailed view of an opening of a cell according to the invention

(6) For more clarity, identical or similar elements are called by identical reference signs in all the figures.

DETAILED DESCRIPTION OF AT LEAST ONE EMBODIMENT

(7) In a first embodiment illustrated in FIGS. 1A-B and 2, the intralaryngeal prosthesis ILP according to the invention has a tubular lower part LP and an upper part UP, the upper part UP comprising: a tubular inner wall 1 comprising a first end, called upper end 2, and a second end, called lower end 3; a tubular outer wall 4 comprising a first end, called upper end 2 and a second end, called lower end 3; said outer wall 4 surrounding the inner wall 1; the inner wall 1 and outer wall 4 connecting at both their first ends 1 and second ends 3; a plurality of ribs 5 extending along 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;
lower part LP of the prosthesis being positioned in the extension of the inner wall 1 of the upper part UP of the prosthesis, thus forming a tubular conduit 7.

(8) Thus, the prosthesis ILP according to the invention ensures the seal between the upper part UP of the prosthesis ILP and the larynx, the outer wall 4 adapting by deformation to the morphology of the larynx. Moreover, the presence of ribs 5 and cells 6 ensures good rigidity to the outer wall and allows local deformations not to affect the whole upper part UP of the prosthesis ILP.

(9) The tubular conduit 7 formed by the lower part LP of the prosthesis ILP and the inner wall 1 of the upper part UP of the prosthesis ILP defines a distal opening 8 in the lower part LP of the prosthesis and a proximal opening in the upper part of the prosthesis (not shown), opposite the distal opening 8, permitting air to circulate in the airways.

(10) In the prosthesis according to the invention, it is also possible to modulate the mechanical strength of the outer wall 4 by changing 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 comprised between 0.1 mm and 1 mm. Preferably, the rib 5 thickness is essentially equal to 0.3 mm and the outer wall 4 thickness is essentially equal to 0.4 mm. In one embodiment, the ribs 5 have a different thickness depending on their position.

(11) In the embodiment illustrated in FIG. 1B, the ribs 5 are eight in number. However, a different number of ribs 5 can be envisaged. An embodiment in which the ribs 5 are three in number can particularly be envisaged. In one preferential embodiment, the ribs 5 are arranged symmetrically relative to a plane F1 going through the main axis X of the prosthesis ILP. When the prosthesis is positioned in the patient's larynx, plane F1 coincides with the sagittal plane.

(12) 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 UP of the prosthesis ILP.

(13) Indeed, in the case where the manufacturing technique for the prosthesis ILP according to the invention involves the use of a mold, this mold must be able to be extracted from the piece obtained. This extraction is generally done by openings, these openings resulting from the shape of the mold used. However, in the prosthesis ILP that is the subject of the invention, the arrangement of openings 9 is important, because an incorrect arrangement of these openings 9 can lead to an accumulation of saliva or the food bolus in the cells 6. By positioning the openings 9 at the lower end 3 of the inner wall 1 and outer wall 4, the risk of accumulation of saliva or the food bolus in the cells 6 is eliminated, since the elements likely to accumulate in the cells 6 are stopped by the outer wall 4 of the upper part UP of the prosthesis ILP.

(14) However, the presence of these openings 9 can cause tissue irritation and, in particular, of the vocal folds which, when the prosthesis ILP is in place in the larynx, are found near the lower end 3 of the inner wall 1 and outer wall 4 of the upper part UP. This is especially the case if the openings 9 are present in the form of slots, the borders of the openings then being in the form of very marked edges.

(15) In order to limit this irritation risk, 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 made by means of a plurality of anchoring strips 13 each terminating by an anchoring area 12 and in that each opening 9 is delimited by two anchoring strips 13, the width of the anchoring strips 13 increasing further from the anchoring area 12.

(16) This configuration limits tissue damage. Indeed, the flared shape of the anchoring strips 13 ensures gradual contact and limits tissue irritation at the lower end 3 of the outer wall 4 and inner wall 1 of the upper part UP. In one embodiment, each opening 9 has the shape of an inverted U.

(17) The distance between the inner wall 1 and outer wall 4 can also vary. In one embodiment, the distance between the outer wall 4 and inner wall 1 is comprised between 0.5 mm and 10 mm. One can also choose to modulate the distance between the inner wall 1 and the outer wall 4 to form protrusions.

(18) In one embodiment, the outer wall 4 is essentially cylindrical and has a first protrusion 10, said protrusion 10 extending over a part of the diameter and at least a part of the length of the outer wall 4 of the upper part of the prosthesis.

(19) This protrusion 10 gives the prosthesis ILP a shape closer to the morphology of the larynx which permits reducing the discomfort caused by the prosthesis while increasing the seal between the larynx and the prosthesis ILP. In one embodiment, the shape and location of this first protrusion 10 are chosen so that, when the prosthesis ILP is in place in the larynx, the first protrusion 10 is located opposite the upper part of the arytenoid cartilages.

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

(21) Diametrically opposed means that the projection in a plane perpendicular to the main axis X of the prosthesis ILP of the second protrusion 11 is diametrically opposed, relative to the diameter of the tubular conduit 7, to the projection of the first protrusion 10 in this same plane. In other words, although diametrically opposed, the two protrusions 10, 11 can be located at a different height along the main axis X of the prosthesis ILP.

(22) Like the first protrusion 10, this second protrusion 11 gives the prosthesis ILP a shape closer to the morphology of the larynx which permits reducing the discomfort caused by the prosthesis ILP while increasing the seal between the larynx and the prosthesis ILP. In one embodiment, the shape and location of this second protrusion 11 are chosen so that, when the prosthesis ILP is in the larynx, the second protrusion 11 is located at the space located just above the anterior commissure of the vocal folds.

(23) This adaptation of the protrusions to the morphology of the larynx is also improved by the presence of the ribs and cells 6 that allows the local deformation of these protrusions 10, 11 and helps to obtain a good adaptation of the prosthesis ILP while reducing the discomfort experienced by the patient.

(24) In one preferential embodiment, the first protrusion 10 and second protrusion 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 protrusion 10 and second protrusion 11. In another embodiment, the ribs 5 are positioned symmetrically relative to the plane of symmetry of the first protrusion 10 and second protrusion 11.

(25) In one embodiment, the lower part LP of the prosthesis ILP comprises protruding external projections 19, for fixing said prosthesis ILP in position inside the larynx by supporting said projections 19 against an inner wall of the larynx. Advantageously, the projections 19 are chevron shaped. These projections 19 allow the prosthesis ILP to be properly held when it is in position in the larynx.

(26) In one embodiment, the prosthesis comprises a valve 17, the valve 17 having: a first part, called movable part 14, having a proximal end and a distal end; a second part, called fixed part 15, having a proximal end, the fixed part 15 being integral with the upper part UP; a hinge 16 connecting the proximal end of the movable part 14 to the proximal end of the fixed part 15 so that the movable part 14 of the valve can be placed in a normal position in which it covers the proximal opening of the tubular conduit 7 or in an open position in which it does not cover the proximal opening of the tubular conduit 7.

(27) In one embodiment, the movable part 14 of the valve 17 has a convex dome shape and the valve 17 is arranged so that in the normal position the distal end of the movable part 14 of the valve 17 forms a rim 18 with an area of the upper part UP of the prosthesis ILP and that a space exists between the distal end of the movable part 14 of the valve and the upper part UP of the prosthesis ILP so that air can enter the proximal opening of the tubular conduit 7 by this space.

(28) Thus, the fact that the movable part of the valve 17 forms a rim that covers a part of the tubular conduit 7 prevents saliva and the food bolus evacuated from the surface of the movable part of the valve 17 from being evacuated into the tubular conduit 7 and therefore into the lower airways. However, to allow air circulation despite everything, the movable part of the valve 17 is configured so that a space exists between the movable part of the valve 17, and more precisely between its rim 18 and the upper part UP of the prosthesis ILP. Air can therefore enter into the tubular conduit 7 by this space, without saliva or the food bolus entering into the tubular conduit because of the rim 18.