Barrier device for bone regeneration

Abstract

A bone regeneration barrier device designed to form a barrier to hermetically seal a space above a bone surface, for example, a tooth, to allow, after insertion of a biomaterial which, upon mineralization, will form new bone over the existing bone, a self-supporting barrier element in the form of a dome (1) or a shell, and means for fixing the barrier element above the bone surface to thus form a volume where the biomaterial can be placed to mineralize and form new bone grafting to the previously existing bone. The device is characterized in that the dome-shaped (1) or shell-shaped barrier element is made of a material, in particular a non-resorbable one, such that the barrier element is radiolucent. Figure for the abstract: Fig. 1

Description

Title of the invention: Barrier device for bone regeneration

[0001] The present invention relates to a device intended to form a barrier in the shape of a dome or shell, in particular in the field of bone regeneration, which makes it possible to create and protect a volume above the surface of a residual bone in order to place there a biomaterial element, which by mineralizing under the protection of the dome with respect to the other tissues, will form new bone in the volume protected by the dome by aggregating on the surface of the residual bone.

[0002] A shell of this type is already known in the prior art, for example from FR2713090A1, in the form of a semi-cylindrical tube made of titanium, which is held above a bone surface to which it is desired to add bone tissue by regeneration by two border seals or a peripheral seal acting as a means of holding the shell at a distance from the surface on which it is desired to regenerate bone, the space inside the shell being protected from the gingival tissue.

[0003] The present invention aims to improve the devices of the prior art by providing a barrier device of the type mentioned above, which makes it possible to further improve the precision of the volume of regenerated bone, thus obtaining new bone corresponding as precisely as possible to what the surgeon initially wishes to obtain.

[0004] According to a first aspect of the invention, a device for bone regeneration intended to form a barrier to hermetically protect a space above a surface of a bone, for example the jawbone, to allow, after insertion of a biomaterial which, by mineralizing, will form new bone above the bone already present, comprises a self-supporting barrier element in the form of a dome or a shell, and means for fixing the barrier element above the surface of the bone to thus form a volume where the biomaterial can be arranged to mineralize and form new bone grafting onto the previously present bone, is characterized in that the barrier element in the form of a dome or shell is made of a material, in particular non-resorbable, such that the barrier element is radiotransparent, that is to say in particular allows X-rays to pass through with a transmission coefficient of at least 60%,preferably at least 70%, preferably 80%, even more preferably 90%, in particular substantially 100%.

[0005] By thus providing a material sufficiently transparent to X-rays, the surgeon can see with sufficient precision the internal volume formed between the barrier element and the surface of the bone to which it is desired to add bone material, and thus precisely conform this volume, to adapt it as much as possible to the shape he wishes to give to the final implant.

[0006] Preferably, and according to another aspect of the invention which constitutes an invention in itself, but which can advantageously be implemented in combination with the first aspect, the barrier element is self-supporting but is elastically deformable, in particular in compression and / or in bending.

[0007] In particular, the barrier element is elastically deformable in compression, this compression capacity making it possible to obtain better bone formation.

[0008] It is thus possible to conform the volume in which bone material is desired to regenerate as precisely as possible and thus obtain an implant having the shape closest possible to what the surgeon wishes to obtain at the start of his operation. In addition, the barrier element can easily be produced by 3D printing.

[0009] In particular, the biomaterial from which the barrier element is formed has a Young's modulus of between 2 and 20 GPa, in particular between 2 and 15 GPa, more particularly between 2 and 5 GPa, in particular between 3 and 4 GPa.

[0010] According to a preferred embodiment of the invention, the material has a flexural strength of between 100 and 200 MPa, in particular between 150 and 190 MPa, in particular substantially equal to 180 MPa.

[0011] According to a preferred embodiment of the invention, the material of the barrier element has a tensile strength of between 50 and 120 MPa, in particular of between 80 and 100 MPa.

[0012] The above values ​​of resistance and Young's modulus are given at room temperature, i.e. between 20 and 25°C, in particular at 23°C and under atmospheric pressure.

[0013] According to a particularly preferred embodiment, the material of the barrier element is a polyaryletherketone (PAK), in particular a polyetheretherketone (PEEK) or a polyetherketoneketone (PEKK).

[0014] According to a preferred embodiment of the invention, the barrier element comprises at least one slot-shaped slide, in particular two slot-shaped slides, preferably four lateral slot-shaped slides which extend in the direction perpendicular to the opening opposite the top of the dome-shaped or shell-shaped barrier and one or more corresponding respective osteosynthesis screws, arranged in a respective slide slot allowing fixation of the barrier element around the surface of the bone to be regenerated, the movement of the screws in the slides making it possible to adjust the volume protected by the barrier element and to maintain the pressure of the barrier element on the biomaterial, pressure obtained thanks to the possible compressive deformation of the barrier element. barrier.

[0015] By way of example, an embodiment of the invention is described with reference to the drawings, in which:

[0016] [Fig. 1] is a perspective view of a barrier element according to the invention in the form of a dome;

[0017] [Fig. 2] is a schematic sectional view of the barrier element of [Fig. 1] disposed over a bone prior to installation; and

[0018] [Fig.3] is a view similar to that of [Fig.2] in the installed position of the barrier.

[0019] In [Fig.l], a dome 1 is shown formed from PEEK having a thickness of 0.5 mm, this thickness being able in particular to be between 0.1 mm and 1 mm. Four sliding slots 2 extend substantially vertically, close to the opening of the dome, formed opposite the top of the dome. Each of the sliding slots 2 receives within it a respective screw 3 which can slide in its respective slot.

[0020] As shown in Figures 2 and 3, the dome 1 is intended to cover a surface of a bone B, leaving a volume protected from other soft tissues, such as the gum or the skin, or the like, in order to be able to insert bone biomaterial therein, which, by mineralizing under the protection of the dome with respect to the other tissues, will form new bone in the volume protected by the dome by aggregating on the surface of the bone B.

[0021] Once the interior volume of the dome is filled with the biomaterial R intended to develop, the surgeon can apply pressure to the dome to compress the biomaterial within it and, using screws, fix the dome in the final position in which it maintains a shape ([Fig.3]) under pressure deformed compared to its initial shape ([Fig.2]).

[0022] On the other hand, the surgeon can also easily see the shape of the interior space of the dome on X-rays and adapt it to the shape of the implant he wishes to create, while being able, thanks to the fixation by the screws and the deformable nature of the wall of the dome, to add or remove biomaterial intended to form regenerated bone.

[0023] As can be seen in [Fig.l] in particular, the wall of the dome is, preferably, solid, without any opening passing through it except for the very fine slots 2, in particular of the order of 0.5 to 3 mm in width for a length of the order of 2 to 15 mm.

[0024] Preferably, the height of the dome, that is to say the distance perpendicular to its opening to its summit, is a function of the need for bone gain, generally of the order of 3 to 15 mm, in the dental field, while this length can be greater, of the order of several centimeters in the orthopedic or maxillofacial field.

Claims

Claims

1. Device for bone regeneration intended to form a barrier to protect a space above a surface of a bone (B), for example the jawbone, to allow, after insertion of a biomaterial which, by mineralizing, will form new bone above the bone already present, comprises a self-supporting barrier element in the form of a dome (1) or a shell, and means for fixing the barrier element above the surface of the bone to thus form a volume where the biomaterial can be arranged to mineralize and form new bone grafting onto the previously present bone, is characterized in that the barrier element in the form of a dome (1) or shell is made of a material, in particular non-resorbable, such that the barrier element is radiotransparent, that is to say in particular allows X-rays to pass through with a transmission coefficient of at least 60%, preferably at least 70%, preferably 80%,even more preferably 90%, in particular substantially 100%.,

2. Device according to claim 1, characterized in that the barrier element (1) is self-supporting but is elastically deformable, in particular in compression and / or in bending.

3. Device according to claim 2, characterized in that the barrier element (1) is elastically deformable in compression.

4. Device according to claim 1, 2 or 3, characterized in that the material from which the barrier element is formed has a Young's modulus of between 2 and 20 GPa, in particular between 2 and 15 GPa, more particularly between 2 and 5 GPa, in particular between 3 and 4 GPa.

5. Device according to one of claims 1 to 4, characterized in that the material of the barrier element has a flexural strength of between 100 and 200 MPa, in particular between 150 and 190 MPa, in particular substantially equal to 180 MPa.

6. Device according to one of claims 1 to 5, characterized in that the material of the barrier element has a tensile strength of between 50 and 120 MPa, in particular of between 80 and 100 MPa.

7. Device according to one of claims 1 to 6, characterized in that the material of the barrier element is a polyaryletherketone (PAK).

8. A device according to claim 7, characterized in that the PAK is a polyetheretherketone (PEEK) or a polyetherketoneketone (PEKK).

9. Device according to one of claims 1 to 8, characterized in that the barrier element (1) comprises at least one slot-shaped slide (2), in particular two slot-shaped slides, preferably four lateral slot-shaped slides which extend in the direction perpendicular to the opening away from the top of the dome- or shell-shaped barrier and one or more corresponding osteosynthesis screws (3), arranged in a respective slide slot allowing fixation of the barrier element around the surface of the bone to be regenerated, the movement of the screws in the slides allowing adjustment of the volume protected by the barrier element, thanks to the possible deformation of the barrier element

10. Device according to one of claims 1 to 9, characterized in that the barrier element (1) protects the space above the surface (B) of the bone to be regenerated in a hermetic manner.

Images