EP3041437A1

EP3041437A1 - Intralaryngeal prosthesis

Info

Publication number: EP3041437A1
Application number: EP14761346.7A
Authority: EP
Inventors: Nicolas Perrin; Maurice BÉRENGER
Original assignee: Protip Medical
Current assignee: Protip Medical
Priority date: 2013-09-05
Filing date: 2014-09-05
Publication date: 2016-07-13
Also published as: CA2923113A1; US20160228239A1; CN105555228A; WO2015032886A1; FR3009951B1; US9913713B2; FR3009951A1

Abstract

The invention relates to an intralaryngeal prosthesis which is not at risk of getting blocked and which allows the patient to breathe comfortably. For this purpose, the prosthesis comprises a tubular body pierced by a proximal opening and a convex dome-shaped valve (10), the valve being arranged such that: the distal end (15) of the valve forms a rim (16) which covers a portion of the tubular body (2), and such that a space (17) exists between the distal end (15) of the valve and the tubular body (2) such that air can enter the proximal opening (8) of the tubular body through said space (17).

Description

INTRA-LARYNGEAL PROSTHESIS

TECHNICAL AREA

The present invention relates to an intra-laryngeal prosthesis. STATE OF THE PRIOR ART

The main function of the larynx is to seal, during swallowing, the airways to protect them and prevent the bolus from entering, instead of passing through the esophagus. This obturation is done by neuromuscular reflex of closure of the glottis, resulting from the adduction of muscle groups arranged on three levels (glottic ary-epi, ventricular bands and vocal cords). In case of dysfunction at one of these levels, it ensues disorders of swallowing, the larynx can no longer ensure proper closure of the airways, so that the bolus can pass into them.

To remedy this problem, the document EP 0 815 807 describes an intra-laryngeal prosthesis, which makes it possible to remedy the dysfunction of the larynx. For this, the intra-laryngeal prosthesis comprises a tubular body which is intended to be inserted into the larynx of a patient. The tubular body having one of its ends shaped bevel. On this end is fixed a shutter valve which is aligned with the beveled end of the tubular body. The shutter valve prevents elements from entering the tubular body. In order to allow the air to penetrate the tubular body in spite of everything, the beveled end is pierced by orifices, which have a substantially crenellated shape and connect the inside and outside of said tubular body. However, these orifices tend to be blocked by saliva or food bolus, which hampers the patient's breathing.

SUMMARY OF THE INVENTION

The invention aims to remedy the drawbacks of the state of the art by proposing an intra-laryngeal prosthesis which prevents the passage of the bolus and saliva into the airways, which does not become clogged and which allows the patient to breathe. easily.

To do this, a first aspect of the invention relates to an intralaryngeal prosthesis configured to be introduced into a larynx, the prosthesis comprising:

A tubular body having a proximal end surrounding a proximal opening; A valve, the valve having a proximal end and a distal end;

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 (or at rest) position in which it covers the proximal opening or in an open position in the which it does not cover the proximal opening;

the valve being arranged so that, in the normal position:

the distal end of the valve forms a rim that covers a portion 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. Thus, the orifices allowing air to circulate in the tubular body are no longer formed by slots made in the tubular body, but by a baffle-shaped space formed between the valve and the tubular body. In addition, the fact that the valve forms a rim which covers a portion of the tubular body prevents the saliva and the food bolus evacuated from the surface of the valve being discharged into the tubular body. However, to allow the flow of air despite everything, the valve is configured so that a space exists between the valve, and more precisely between its flange, and the tubular body. The air can therefore enter the tubular body through this space, without saliva or food bolus entering the tubular body due to the rim.

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

Advantageously, the valve has a domed domed shape, which prevents the stagnation of the bolus and saliva on the valve, since these elements are evacuated by gravity.

However, it is possible to envisage other geometries of the valve, and in particular that the valve is flat (it could then be beveled with respect to the tubular body, that is to say that the valve plant is not perpendicular to the valve. axis of the tubular body). The other geometries of the valves must be determined in such a way that they prevent stagnation of the bolus or saliva on the valve, and must slide into the esophagus because of gravity.

The tubular body preferably extends, at least over a portion, along a reference axis so as to be inserted into the larynx of a patient.

In a particular embodiment, the tubular body has two zones:

A first zone (I) (for example cylindrical) extending along a reference axis (this zone being intended to be inserted wholly or partly in the larynx of a patient, or at the end a tracheal ring as described in the application WO 2013/079362)

A second zone (II) (including the proximal end) having outer dimensions smaller than the outer dimensions of the first zone (such that the first zone is moved to the second zone by narrowing the outer dimensions of the body tubular). Generally, the inner lumen (cross section, proximal opening (8)) of the second zone is smaller than the inner lumen defined in the first zone. This second zone may be of frustoconical shape, or in the form of a bevel (or in the form of a whistle or a recorder's mouthpiece).

If the first zone (I) is generally of revolution about an axis, the second zone (II) does not necessarily have an axis of symmetry.

The principle of the implementation of this embodiment allows to use a valve having the same diameter as the first cylindrical zone of the tubular body, while maintaining the space between the proximal portion of the tubular body and said valve.

In fact, and by construction in order to maintain the space between the valve and the tubular body, the dimensions of the valve are greater than those of the proximal end of said tubular body. However, it is not possible to reduce too much the size of the portion of the tubular body to be inserted into the larynx of the patient so that the patient can breathe without discomfort or effort. In some cases, the use of a larger valve (diameter) than that of the tubular body may cause discomfort after implantation in the patient.

Thus, the use of a tubular body as described above and whose proximal end is of smaller dimension than the distal dimensions of said tubular body, thus reduces the size of the valve and use a valve of diameter equal to that of the distal end of the tubular body, while maintaining the space between the proximal portion of the tubular body and the flange of said valve who covers it.

The fact that the valve forms a rim which covers a portion of the tubular body and that a space exists between this part of the tubular body and the rim can be achieved in different ways.

In particular, it is possible to provide a valve that is off-center with respect to the tubular body so that:

the distal end of the flap forms a rim that covers a portion 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.

The valve is preferably offset in a direction opposite to that of the hinge. It can also be provided that the valve has transverse dimensions greater than those of the tubular body so that:

Of course, the two previous embodiments can be performed separately or in combination.

According to one embodiment, the valve comprises a lid having weakened zones, the lid being able to be pierced by an intubation probe. Thus, the valve can be pierced easily and quickly during emergency intubation. The lid preferably comprises a reception area adapted so that an intubation probe can be placed in this reception area without the risk of slipping on the upper face of the valve. Advantageously, the valve has a lower face, the hinge being elastically deformable so as to allow the passage of the valve in the open position when a force greater than a threshold force is exerted on the underside of the valve. Thus, during a sputum, a cough, a strong expiration, or when the surgeon wants to control the airway using an endoscope, for example, the hinge allows the opening of the flap to the top. Advantageously, the valve has a lower face, the hinge being elastically deformable so as to return the valve in the normal position when no force greater than a threshold force is exerted on the underside of the valve. Thus, in normal breathing, the valve remains in the normal position and therefore it covers the proximal opening of the tubular body so as to protect it.

According to a preferred embodiment, the valve has an upper face, the upper face of the valve being treated, at least in part, a release treatment. The non-stick treatment strengthens the effect of the shape of the valve in order to avoid stagnation of the bolus and saliva on the valve. This non-stick treatment may for example be achieved by polishing or microbotting the upper face of the valve or by a release layer deposited on the valve.

The proximal end of the tubular body may also be treated by a surface treatment.

Advantageously, the valve comprises centering means arranged on its lower face, the proximal end of the tubular body having complementary centering means, the centering means of the valve being arranged to cooperate with the complementary means of the tubular body so as to guide the valve and ensure that it returns to the desired position as 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 underside of the valve. The complementary centering means can in this case be formed by a truncated conical orifice formed in a transverse wall of the tubular body, the orifice being adapted to receive the centering cone. This technical solution ensures that the valve returns to the neutral position.

Advantageously, the tubular body comprises a resiliently deformable central portion, which allows to easily insert without surgery the intra-laryngeal prosthesis in the larynx of a patient.

The central portion of the tubular body is preferably made of silicone. The proximal end of the tubular body is preferably made of titanium so as to facilitate the attachment of the hinge to the tubular body and to avoid deformation of the proximal end when the hinge is deformed.

Advantageously, the valve is made of titanium so as to be rigid enough not to deform under the effect of the bolus or saliva.

Advantageously, the valve is elliptical so as to better adapt to the patient's anatomy.

Advantageously, the hinge is made of silicone, but it can also be with any other biocompatible elastic material. As described below, the hinge has a sufficient restoring force to allow the valve to cover the proximal opening when it is at rest, but to open when a force greater than a threshold force is applied to the face bottom of the flap.

All the materials used to make the intra-laryngeal prosthesis is biocompatible.

According to various embodiments, the tubular body may be flexible, semi-rigid or even rigid.

Advantageously, said tubular body has projecting external nipples, for fixing said prosthesis in position inside the larynx, by pressing said nipples against the inner wall thereof.

Advantageously, to allow said prosthesis to be easily housed at the vocal cords, the distal end of said tubular body, opposite the proximal end has a smaller diameter than the side of the proximal end, or that the central portion of the tubular body.

Advantageously, the distal end is beveled.

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 - Figure 1, a sectional view of an intra-laryngeal prosthesis according to one embodiment of the invention;

FIG. 2, a perspective view of the intra-laryngeal prosthesis of FIG. 1;

- Figure 3, a side view of the prosthesis of Figure 1;

- Figure 4, a front view of the prosthesis of Figure 1;

- Figure 5, a top view of the prosthesis of Figure 1;

FIG. 6, an enlarged view of the inside of the prosthesis of FIG.

- Figure 7, a sectional view of the zone (I) containing the proximal opening (8) of the tubular body (2) in the form of a recorder mouthpiece, and a small portion of the zone (I). ) of the tubular body (2), and the valve (10) whose diameter is identical to that of the cylindrical zone (I) of the tubular body (2). This figure shows the valve (10) in the rest position. The gap (17) between the distal end (15) of the valve (10) and the tubular body is also observed, allowing air to flow and the patient to breathe.

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

With reference to the figures, the intra-laryngeal prosthesis 1 comprises a tubular body 2. The tubular body 2 extends along a reference axis 3. The tubular body 2 has a tubular shape around the reference axis. The tubular body 2 preferably comprises a central portion 4. The central portion 4 is preferably elastically deformable. For this, the central portion 4 is preferably made of silicone. The intra-laryngeal prosthesis can thus be inserted easily by the endobuccal route and without surgery in the larynx of a patient. The central portion 4 may be provided with asperities 5 so as to facilitate its retention in the larynx of the patient. The prosthesis can be put in place without tracheotomy.

In the case where the tubular body contains a zone (I) and a zone (II) as described above, the central portion is present in the zone (I).

The tubular body 2 also has a proximal end 6 and a distal end 7. The proximal end 6 and distal 7 are opposite. The distal end 7 is preferably bevelled. The proximal end 6 is preferably rigid, so as to be more resistant, and to allow the fixing of a hinge and to allow the good return in position of the valve on the tubular body. The rigid proximal end 6 also makes it possible to fix the ancillary for placing the intra-laryngeal prosthesis. The proximal end 6 is preferably made of titanium.

The proximal end 6 is pierced by a proximal opening 8. The proximal opening 8 opens onto a cylindrical opening 9 which passes right through the tubular body 2.

The intra-laryngeal prosthesis 1 preferably comprises a valve 10. The valve 10 can be placed in a normal position in which it covers the proximal opening 8 and an open position in which it does not cover the proximal opening 8. The valve 10 is preferably made of titanium. The valve 10 has a lower face 12 and an upper face 13. The lower face 12 of the valve is directed towards the tubular body. The upper face 13 of the valve is directed away from the tubular body. The valve 10 has a proximal end 14 and a distal end 15. The lower face 12 of the valve is preferably provided with centering means 18 arranged to fit in complementary centering means 19 of the tubular body 2 so as to provide the good positioning of the flap as it moves from the open position to the normal position. These centering means 18 may for example comprise a centering cone, the complementary centering means 19 having a complementary conical orifice.

The valve 10 is connected to the tubular body 2 by a hinge January 1 which is elastically deformable so as to allow the passage of the valve from the normal position to the open position and vice versa. In other words, the hinge is flexible, it can bend. More specifically, the proximal end 14 of the valve is connected to the hinge January 1. The hinge January 1 is preferably made of silicone. The hinge January 1 is shaped to allow the passage of the valve in the open position when a force greater than a threshold force is applied to the lower face 12 of the valve 10. Thus, in case of expectoration, the valve opens to facilitate the expiration of the patient. This is also the case in case of coughing or sneezing. The surgeon can also open the flap to make a check airways, for example by endoscope. Furthermore, the hinge January 1 is shaped to bring the valve 10 in the normal position when no force greater than the threshold force is applied to the lower face 12 of the valve. Thus, the valve 10 is always returned to the normal position so as to protect the proximal opening 8, except in case of force greater than the threshold force. In normal breathing, the valve 10 is in the normal position.

In order to prevent the passage of saliva and / or bolus into the proximal opening 8 of the tubular body, while allowing the passage of air through this opening, the intra-laryngeal prosthesis has the characteristics detailed below. after.

The valve 10 preferably has a convex shape. More specifically, the valve 10 preferably has a convex shape and a concavity facing the tubular body 2. Thus, by gravity effect, the food bolus that would be deposited on the valve would be evacuated. The dome shape thus makes it possible to avoid stagnation of the bolus and saliva on the valve. In addition, to enhance this effect, one can provide a release coating on the upper surface 13 of the valve.

In this embodiment, the valve has a symmetry of revolution. However, it could also have a valve which has an elliptical cross section, of greater axis parallel to a transverse axis 20 connecting the proximal end of the valve at its distal end, or a larger axis perpendicular to such a transverse axis 20.

In addition, the valve 10 is arranged so that:

the distal end 15 of the valve forms a flange 16 which covers a portion 30 of the tubular body 2 and that

a space 17 exists between the distal end 15 of the valve 10 and the tubular body 2 so that air can enter the proximal opening 8 of the tubular body 2 by this space 17.

For this, it is possible in particular to provide that the valve has transverse dimensions greater than the transverse dimensions of the body In this document, the term "transverse dimensions" refers to a dimension taken perpendicularly to the reference axis 3 of the tubular body.

According to another embodiment, it is possible to offset the valve 10 relative to the tubular body, so that the valve 10 is offset in the opposite direction to the hinge 1 1. Naturally, these two embodiments can be used independently of one another or in combination.

The space 17 and the space between the lower face 12 of the valve and the transverse wall at the distal end 6 form a baffle which allows the air to enter the proximal opening 8, while avoiding that food or saliva can enter the proximal opening 8.

The flange 16 is preferably cut to fit the tubular body 2 in the longitudinal direction, on either side of the space 17.

Furthermore, the valve 10 may be provided with a lid 31 which has weakened zones 32 so that the lid can be pierced by an intubation probe in case of emergency intubation. The lid 31 is preferably made of silicone. The lid 31 is preferably overmolded on the valve 10 at the same time as the hinge January 1 which is also preferably overmolded on the valve 10. The valve 10, preferably made of titanium, is provided with through holes placed on the periphery of the seal which make it possible to ensure the mechanical strength of the seal 31 on the valve 10. The seal 31 is hermetic as long as it is not torn and is sufficiently strong not to be pierced by food or saliva. The cover 31 may for example be made in the following manner: firstly, the seal 31 of silicone is overmolded on the valve 10. In a second step, a tool provided with blades allows to come notch the center of the opercule 31, preferably in the form of cross, cross, or flake-shaped. These notches are not through: a thin silicone thickness allows to join together parts of the cap. This keeps a seal between the top and bottom of the valve. This technical solution will, once pierced by an intubation probe, to keep the petals of the seal linked to the valve. According to various embodiments, the lid may be flat, as shown in Figures 1 and 4, or curved. Furthermore, the lid may comprise a reception zone 33 adapted to receive the end of a probe so as to prevent the end of the probe from slipping on the lid. For this purpose, the reception area preferably forms a concave hollow of concavity turned to the opposite of the tubular body 2. In other words, the concavity of the reception zone 33 is preferably opposite to the concavity of the valve 10. The reception zone 33 is preferably aligned with the reference axis 3 of the body tubular 2, so as to initiate the guidance of an intubation probe in the axis of the tubular body. Consequently, when the valve is off-axis with respect to the tubular body, the receiving zone is off-axis with respect to the valve.

Naturally, the invention is not limited to the embodiments described with reference to the figures and variants could be envisaged without departing from the scope of the invention. The valve could in particular have a shape other than the curved shape: it could for example be triangular or trapezoidal.

Claims

1. An intra-laryngeal prosthesis (1) configured to be inserted into a larynx, the prosthesis comprising:

- A tubular body (2) having a proximal end (6) surrounding a proximal opening (8);

A valve (10) having a proximal end (14) and a distal end (15);

A hinge (1 1) connecting the proximal end (14) of the valve (10) to the proximal end (6) of the tubular body (2) so that the valve (10) can be placed in a normal position in which it covers the proximal opening (8) or in an open position in which it does not cover the proximal opening (8);

Characterized in that the valve (10) is arranged so that, in the normal position:

the distal end (15) of the valve forms a flange (16) which covers a portion of the tubular body (2) and that

a space (17) exists between the distal end (15) of the valve and the tubular body (2) so that air can enter the proximal opening (8) of the tubular body through this space (17) .

2. Intra-laryngeal prosthesis (1) according to claim 1, wherein the valve (10) has a curved domed shape.

3. Intra-laryngeal prosthesis (1) according to one of claims 1 or 2, wherein the tubular body (2) extends along a reference axis (3), the valve (10) being offset from the body tubular (2) in a direction opposite to the hinge (1 1).

4. Intra-laryngeal prosthesis (1) according to one of claims 1 to 3, wherein the tubular body (2) extends along a reference axis (3), the valve (10) having transverse dimensions greater than those of the tubular body.

5. intra-laryngeal prosthesis (1) according to one of claims 1 or 2, wherein the tubular body has a first zone (I) extending according to a reference axis, and a second zone (II) having external dimensions smaller than the external dimensions of the first zone.

The intra-laryngeal prosthesis according to claim 5, wherein the second zone is frustoconical, bevel-shaped, whistle-shaped or beak-shaped.

7. intra-laryngeal prosthesis (1) according to one of claims 1 to 5, wherein the valve (10) comprises a seal having weakened areas, the seal being adapted to be pierced by an intubation probe.

8. intra-laryngeal prosthesis (1) according to claim 7, wherein the lid comprises a receiving zone adapted to receive the end of an intubation probe.

9. intra-laryngeal prosthesis (1) according to one of claims 1 to 8, wherein the valve (10) has a lower face (12), the hinge (1 1) being elastically deformable to allow the passage of the valve (10) in the open position when a force greater than a threshold force is exerted on the lower face (12) of the valve (10).

10. Intra-laryngeal prosthesis (1) according to one of claims 1 to 9, wherein the valve (10) has a lower face (12), the hinge (1 1) being elastically deformable so as to bring the valve ( 10) in the normal position when no force greater than a threshold force is exerted on the lower face (12) of the valve (10).

1 1. Intra-laryngeal prosthesis (1) according to one of claims 1 to 10, wherein the valve (10) has an upper face (13), the upper face (13) of the valve (10) being treated, at least in part , a non-stick treatment.

12. intra-laryngeal prosthesis (1) according to one of claims 1 to 1 1, wherein the tubular body (2) comprises a central portion (4) elastically deformable.