FR3063633A1 - TRACHEAL RING PROSTHESIS DEVICE AND TOTAL OR PARTIAL TRACHEAL PROSTHESIS DEVICE - Google Patents

Abstract

A tracheal ring prosthesis device which is in the form of an open ring, C-shaped, longitudinally comprising a multiplicity of perforations (3), and whose two end parts (10, 11) are offset, c ' that is to say that they are not in the axial extension of one another. The total or partial tracheal prosthesis device is intended to be sutured to the healthy trachea as a replacement for the resected part, it is in the form of a tubular element, made of a flexible material, comprising at least one peripheral tunnel. in which is inserted a tracheal ring prosthesis device (1).

Description

(54) TRACHEAL RING PROSTHESIS DEVICE AND TOTAL OR PARTIAL TRACHEA PROSTHESIS DEVICE.

FR 3 063 633 - A1 (57) Tracheal ring prosthesis device which is in the form of an open ring, C-shaped, longitudinally comprising a multiplicity of perforations (3), and of which the two end parts ( 10,11) are offset, that is to say that they are not in the axial extension of one another.

The total or partial trachea prosthesis device is intended to be sutured to the healthy trachea to replace the resected part, it is in the form of a tubular element, made of a flexible material, comprising at least one peripheral tunnel into which is inserted a tracheal ring prosthesis device (1).

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The present invention relates to a tracheal ring prosthesis device, as well as a total or partial tracheal prosthesis device comprising said tracheal ring prosthesis device.

The trachea can be prone to different pathologies and traumas, requiring total or partial replacement surgery. There are thus known artificial tracheas mainly consisting of a tubular element, generally made of plastic, associated with anti-crushing stiffening means such as rings.

Such a tracheal implant is described in document WO 2016/081709, it comprises a tubular silicone element reinforced with portions of C-shaped rings, made of a harder material.

The disadvantage of implants of this type is essentially the risk of rejection.

The object of the present invention is to provide a tracheal ring prosthesis device which can be used in an operating technique which makes it possible to remedy the risk of rejection.

The tracheal ring prosthesis device according to the invention is characterized in that it is in the form of an open ring, C-shaped, and the two end parts of which are offset, that is to say say that they are not an extension of each other.

According to an additional characteristic of the tracheal ring prosthesis device according to the invention, it consists of a curved flat bar made of titanium.

According to another additional characteristic of the tracheal ring prosthesis device according to the invention, the flat bar has longitudinally a multiplicity of perforations.

According to another additional characteristic of the tracheal ring prosthesis device according to the invention, it comprises oblong perforations, of major axis making an oblique angle relative to the longitudinal axis of the flat bar.

According to another additional characteristic of the tracheal ring prosthesis device according to the invention, it has an elliptical shape.

The tracheal ring prosthesis device according to the invention is intended to constitute the reinforcement of a tubular element itself intended to be sutured with the healthy trachea in replacement of the resected part. This tubular element can be made of different materials advantageously having a certain flexibility. If the tubular element can be made of a synthetic material, it originates preferably consists of a flap of skin taken from the patient. This skin flap is rectangular in shape, the dimensions of the tracheal part to be replaced, and is pierced longitudinally with a tunnel to allow the introduction of the open ring.

The present invention therefore also relates to a device for partial or total prosthesis of the trachea, intended to be sutured to the healthy trachea in replacement of the resected part, which is characterized in that it is in the form of an element tubular made of a flexible material, comprising at least one peripheral tunnel into which a tracheal ring prosthesis device conforming to the above description is inserted.

The offset of the end portions of the ring make it possible to thread the ring into the peripheral tunnel starting with one end part of the ring without being hindered by the other end part.

Note that the offset or offset of the end parts of the ring can be achieved in different ways, preferably it is made so that the open ring is in the form of a portion of helical turn.

In practice, when the tubular element is produced from a skin flap taken from the patient, the tunnel is created by means of a stylet introduced longitudinally into said skin flap, in its thickness, between two layers of said skin, then a tractor wire is introduced there which is hooked at one end of the C to pull it through said tunnel.

The dimensions of the skin flap are chosen according to those of the part of the trachea to be replaced, and provision may be made for inserting therein more than one C-shaped ring.

After insertion of the ring (s), the longitudinal edges of the skin flap are sutured to the healthy parts of the trachea.

The perforations are intended to promote cell recolonization, the oblong perforations making it possible to reduce the quantity of material and to limit the weight, while their inclination makes it possible to avoid a risk of folding or breaking during the bending operation.

The advantages and characteristics of the prosthesis devices according to the invention will emerge more clearly from the description which follows and which relates to the appended drawing, which represents a non-limiting embodiment thereof.

In the attached drawing:

- Figure 1 shows a schematic perspective view of a tracheal ring prosthesis device according to the invention.

- Figure 2 shows a schematic plan of the same device during a stage of its manufacture.

- Figure 3 shows a schematic perspective view of a partial trachea prosthesis device according to the invention.

Referring to Figure 1, we can see a device 1 for tracheal ring prosthesis according to the invention. It is in the form of an open, C-shaped ring, the end portions 10 and 11 of which are not in line with one another, but offset to move away from each other. 'a median plane. Thus, the ring device 1 has the general shape of a portion of helical coil.

With reference also to FIG. 2, it can be seen that the ring prosthesis device 1 is in the initial form of a rectangular bar 2, preferably made of titanium, in which perforations 3 are made, which are intended for cell recolonization.

In the embodiment shown, the perforations are, without limitation, of two types, round perforations 30 distributed along the longitudinal edges 21 and 22 of the bar 2, and oblong perforations 31 distributed longitudinally in the central part.

The oblong perforations 31 preferably have a particular orientation, namely that their major axis YY 'is inclined relative to the longitudinal axis XX' of the bar 2, so that during the bending operation to give it its shape d 'open ring, there is no risk of folding or breaking, as could be the case with oblong perforations of large transverse axis, that is to say perpendicular to the longitudinal axis of the bar 2.

Referring now to Figure 3, one can see a partial tracheal prosthesis device, using the tracheal ring prosthesis device 1 according to the invention.

The partial tracheal prosthesis device consists of a flexible element shaped as a sleeve intended to be placed in replacement of the resected part of the trachea, and reinforced by one or more tracheal ring devices.

This flexible element may consist of a compatible tissue, or of synthetic skin, but it is preferably constituted by a skin flap 4, taken beforehand from the patient, of rectangular shape, of length corresponding to the circumference of the trachea to equip, and of width greater than that of the bar 2.

The skin flap 4 is previously subjected to a preparation, not illustrated. Thus, by means of a cutting tool, such as a stylus, a tunnel 40 is practiced in the skin flap 4, in the longitudinal direction, then the open ring 1 is threaded into this tunnel 40, advantageously using a pulling wire that is hooked at one end of the C to pull the latter into said tunnel 40. The purpose of shifting the end portions 10 and 11 is to facilitate this operation of threading the skin flap 4 onto an end part, 10 or 11, of the ring 1 without being hindered by the other end part.

These operations make it possible to obtain a sleeve 5, as shown in FIG. 3, and which comprises the skin flap 4 shaped into a cylinder, and reinforced with the ring 1.

The sleeve 5 is then intended to replace the part to be replaced of the trachea, by being sutured by each of its edges 50 and 51 to the healthy part of the trachea.

It is obvious that a sleeve 5 may have more than one ring 1, depending on the dimensions of the trachea part to be replaced, the skin flap 4 being dimensioned accordingly.

It is also possible to envisage suturing several sleeves 5, each comprising one or more rings 1.

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Claims (8)

1) Tracheal ring prosthesis device (1) characterized in that it is in the form of an open ring, C-shaped and whose two end parts (10, 11) are offset, that is to say that they are not in the 5 axial extension of one another. 2) Tracheal ring prosthesis device (1) according to claim 1, characterized in that it consists of a curved flat bar (2) made of titanium. 3) Tracheal ring prosthesis device (1) according to claim 2, characterized in that the flat bar (2) has longitudinally a multiplicity of perforations (3). 4) Tracheal ring prosthesis device (1) according to claim 3, characterized in that it comprises oblong perforations (31), of major axis (YY ') making an angle 15 oblique to the longitudinal axis (XX ') of the flat bar (2). 5) Tracheal ring prosthesis device (1) according to any one of the preceding claims, characterized in that it is generally elliptical in shape. 20 6) A tracheal ring prosthesis device (1) according to any one of the preceding claims, characterized in that it is made of titanium. 7) Device for partial or total prosthesis of the trachea (5), intended to be sutured to the healthy trachea as a replacement for 25 the resected part, characterized in that it is in the form of a tubular element, made of a flexible material, comprising at least one peripheral tunnel (40) into which a tracheal ring prosthesis device is inserted (1) according to any one of claims 1 to 6. 30 8) Device for partial or total prosthesis of trachea according to claim 7, characterized in that the flexible material from which the tubular element is made consists of a skin flap (4) taken from the patient. 1/1 40 11