Bone regeneration kit and device forming part of such a kit

Abstract

Bone regeneration kit and device forming part of such a kit. Bone regeneration kit, intended to form a barrier to protect a space above a bone surface, for example, the jawbone, to allow, after insertion of a mineralizing biomaterial, the formation of new bone above the existing bone, comprising: on the one hand, a self-supporting barrier element, pierced with at least one through-hole, in particular of circular cross-section; and on the other hand, at least one plug made of a second material having a shape and dimensions adapted to plug the through-hole(s); the kit further comprising means for fixing the barrier element above the bone surface to thus form the space where the biomaterial is placed to mineralize and form new bone by grafting to the previously existing bone. Figure for the abbreviation: Fig. 4

Description

Title of the invention: Kit for bone regeneration and device forming part of such a kit

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

[0002] Prior art already knows, for example from FR3134965A1 in the name of the applicant, a device for bone regeneration intended to form a barrier to protect a space above a surface of a bone, for example of the jaws, to allow, after insertion of a biomaterial which by mineralizing will form new bone above the bone already present, comprising a self-supporting barrier element in the form of a dome or a shell and means of fixing the barrier element above the surface of the bone so as to form the volume where the biomaterial can be placed to mineralize and form new bone grafting to the bone previously present.

[0003] The present invention aims to improve prior art devices by providing a barrier-forming device of the kind mentioned above, which makes it possible to further improve the accuracy of the volume of regenerated bone, thus obtaining new bone that corresponds as precisely as possible to what the surgeon initially wishes to obtain, and in addition, in a shorter time.

[0004] According to a first aspect, the invention relates to a bone regeneration kit, intended to form a barrier to protect a space above a bone surface, for example the jawbones, to allow, after insertion of a mineralizing biomaterial, the formation of new bone above the existing bone, comprising: - on the one hand, a self-supporting barrier element, for example in the form of a dome or a shell, made of a first material, in particular impermeable to gingival cells, for example PEEK, Zirconia, Titanium or any other non-resorbable or resorbable biocompatible material such as Magnesium or similar materials, pierced with at least one through opening, in particular of circular cross-section; and - on the other hand, at least one stopper made of a second material, different from the first material, in particular having cell impermeability gingivals which deteriorate faster than that of the first material, particularly in bone matter, having shape and size adapted to plug the through opening(s); the kit also includes means of fixing to fix the barrier element above the surface of the bone in order to form the space where the biomaterial is disposed to mineralize and form new bone by grafting to the previously present bone.

[0005] The bone constituting the plug material, autologous, taken from the patient, particularly in the oral area, or from bone banks, gradually passes from an initial non-porous state, impermeable to gingival cells, particularly for a sufficient time to allow bone neoformation, in particular by protecting the biomaterial against fibrosis created by contact with these cells in the early stages of regeneration, to a porous state, allowing the release of growth factors from the covering tissue of the gingiva and the penetration of blood vessels into the neoformed bone, without the gingival cells being able to pass through, thus accelerating bone formation.

[0006] Preferably, the opening or each through opening has a larger dimension between 3 and 10 millimeters, in particular between 4 and 8 millimeters (mm).

[0007] Preferably, the inscribed circle of the opening or of each opening, that is to say the largest circle that can be virtually drawn in the opening, has a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters,

[0008] Preferably, the through opening or openings are circular in cross-section, and preferably their diameter is between 3 and 10 millimeters, in particular between 4 and 8 mm.

[0009] According to a favorable embodiment, the barrier element, apart from the through opening(s) and the means of fixation, is impermeable to gingival cells but can be permeable to ions, for example by having microperforations on all or part of its surface, the largest dimension in width of the microperforations, in particular their diameter, being on the order of 1 to 5 micrometers.

[0010] According to a favorable embodiment, the barrier element, for example in the shape of a dome or shell, is made of a material, in particular non-absorbable, such that the barrier element is radio-transparent, 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%.

[0011] According to a particularly preferred embodiment, the material of the non-resorbable barrier element is a polyaryletherketone (PAEK), in particular a polyetheretherketone (PEEK) or a polyetherketoneketone (PEKK).

[0012] Other examples of suitable materials include polylactic acid (PLA) and polyglycolic acid (PGA), which are resorbable.

[0013] According to another equally favorable embodiment, the barrier-forming element is zirconium dioxide.

[0014] According to another equally favorable embodiment, the barrier-forming element is made of resorbable magnesium.

[0015] According to one embodiment, the fixing means comprise perforations formed in the barrier element and one or more corresponding respective osteosynthesis screws disposed in the respective perforations, the largest dimension in width of the perforations, in particular their diameter, being less than 3mm, in particular in the order of 1 to 2mm.

[0016] According to another possible embodiment of the invention, the fixation means comprise at least one slot-shaped slide, in particular two slot-shaped slides, preferably four lateral slot-shaped slides formed in the barrier element and extending 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, disposed 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 and maintaining the pressure of the barrier element on the biomaterial.

[0017] Preferably, the barrier element is self-supporting but is elastically deformable, particularly in compression and / or bending.

[0018] Preferably, the element, with the through opening or each through opening plugged by a respective plug, forms a barrier to hermetically protect, preferably temporarily, the space above a surface of a bone, for example the jaws.

[0019] In particular, the barrier element is elastically deformable in compression, this compression capacity allowing for better bone formation.

[0020] This allows the volume in which bone tissue is to regenerate to be shaped as precisely as possible, thus obtaining a bone volume with a form as close as possible to what the surgeon initially intended. Furthermore, the barrier element can easily be produced by 3D printing, machining, or other similar techniques.

[0021] In particular, the biomaterial in which the barrier element is formed has a Young's modulus 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.

[0022] According to a preferred embodiment of the invention, the material has a flexural strength between 100 and 200 MPa, in particular between 150 and 190 MPa, in particular equal to substantially 180 MPa.

[0023] 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 between 80 and 100 MPa.

[0024] 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.

[0025] The present invention also relates to a bone regeneration device intended to form a barrier to protect a space above a bone surface, for example a tooth, to allow, after insertion of a biomaterial which by mineralizing will form new bone above the bone already present, comprising a self-supporting barrier element, for example in the form of a dome or shell made of PEEK, Titanium or Magnesium, and means for fixing the barrier element above the bone surface to thus form a volume where the biomaterial can be disposed to mineralize and form new bone grafting onto the previously present bone, characterized in that the barrier element, for example in the form of a dome or shell, has at least one through opening of circular cross-section having a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters.

[0026] Preferably, the barrier element, apart from the circular cross-section through opening(s) and the means of fixing, is impermeable to gingival cells but permeable to ions and nutrients, for example by having microperforations on all or part of its surface, the largest dimension in width of the microperforations, in particular their diameter, being on the order of 1 to 10 micrometers.

[0027] The present invention also relates to a bone regeneration device intended to form a barrier to protect a space above a bone surface, for example, a tooth, to allow, after insertion of a biomaterial which, upon mineralization, will form new bone above the existing bone, consisting solely of a self-supporting barrier element, for example in the form of a dome 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 onto the previously existing bone, characterized in that the barrier element, for example in the form of a dome or a shell, has at least one through opening whose inscribed circle (largest circle that can be virtually drawn in the opening) has a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters, and in particular the barrier element not having any cover for closing the through opening(s).

[0028] By way of example, embodiments of the invention are described, with reference to the drawings, in which:

[0029] Fig. 1 is a perspective view of a kit according to the invention;

[0030] Fig. 2 is a schematic cross-sectional view of the barrier element of the kit. the [Fig.l] placed above a bone before its installation;

[0031] [Fig.3] is a view similar to that of [Fig.2] in the installed position of the kit;

[0032] Fig. 4 is a perspective view of another kit.

[0033] In [Fig. 1], the kit shown comprises a dome 1, for example made of PEEK, having a thickness of 0.5 mm, this thickness being in particular between 0.1 mm and 1 mm. Four sliding slots 2 (only two are visible in the figure) extend substantially vertically, near the opening of the dome, formed opposite the apex of the dome. Each of the sliding slots 2 is designed to receive within it a respective screw 3 which can slide in its respective slot, the slots and screw together forming fastening means for fixing the dome-shaped barrier element around a bone to be regenerated.

[0034] These slots 2 are very fine, in particular on the order of 0.5 to 3mm in width, that is to say parallel to the edge of the opening of the dome, for a length, in the vertical direction going from the free edge towards the top of the dome, on the order of 2 to 15 mm.

[0035] On the other hand, there is formed in the dome 1 at least one circular through opening 4, of diameter greater than the dimension of the slots 2 in their width, in particular of a diameter between 3 and 10mm, in particular between 4 and 8mm.

[0036] For example, one could provide only one through opening, or on the contrary, provide two through openings, in particular diametrically opposed, or more than two through openings, in particular three or four through openings, in particular distributed, in particular regularly, on the surface of the hull.

[0037] The kit also includes a bone stopper 5.

[0038] The bone constituting the plug 5 could be taken from the patient, notably in the form of a core sample obtained with a trephine, or be sourced from a bone bank. The shape and dimensions of the plug 5 are such that when it is positioned in the opening 4, the latter is completely sealed.

[0039] In the case where several through openings 4 are provided, a corresponding number of bone plugs 5 are provided.

[0040] Figure 4 shows another kit according to the invention. In Figure 4, the kit shown comprises a dome 10, for example made of PEEK, having a thickness of 0.5 mm, this thickness being in particular between 0.1 mm and 1 mm. Four perforations 20 (only two are visible in the figure) are formed near the free edge of the dome opening, opposite the apex of the dome, the perforations being regularly distributed along the circumference of the free edge of the dome. Each of the perforations 20 receives within it a respective screw 30, for fixing the dome around the bone to be regenerated. These perforations 20, preferably circular in cross-section, are very fine, in particular on the order of 0.5 to 3 mm in diameter.

[0041] On the other hand, a through opening 40 of circular section is formed in the dome 10, with a diameter greater than the diameter of the perforations 20, in particular with a diameter between 3 and 10mm, in particular between 4 and 8mm.

[0042] According to another embodiment, two through openings could be provided, in particular diametrically opposed, or more than two through openings, in particular three or four through openings, distributed, in particular regularly, over the surface of the dome.

[0043] The kit also includes a 50 bone stopper.

[0044] The bone constituting the plug 50 could be taken from the patient, notably by means of a trephine, in the form of a core sample, or be obtained from a bone bank. The dimensions and shape of the plug 50 are such that when it is positioned in the opening of the window 40, the latter is completely blocked.

[0045] In the case where several through openings 40 are provided, a corresponding number of bone plugs 50 are provided.

[0046] In the two embodiments shown in Figures 1 and 4 respectively, each dome 1 or 10 may include microperforations allowing neovascularization to access the biomaterial from the tissues, in addition to that from the native bone. However, these microperforations are sufficiently small to prevent gingival cells from passing through the wall; in particular, these microperforations are circular in shape and have a diameter of between 1 and 5 micrometers.

[0047] As shown in the figures, the domes 1 or 10 are each intended to cover a surface of a bone B, leaving a volume protected from other soft tissues, such as the gum or skin, or similar, in order to insert, in particular through the through opening(s) 4 or 40 or also from below in the case of dome 1 having the sliding slots, bone biomaterial, which, by mineralizing under the protection of the dome with respect to other tissues, will form new bone in the volume protected by the dome by associating with the surface of bone B.

[0048] Once the dome's interior volume is filled with the biomaterial R intended to grow, the surgeon seals the through opening(s) 4 or 40 with its respective plug 5 or 50. The surgeon can then also apply pressure to the dome to compress the biomaterial R inside and, using screws 3 or 30, fix the dome in its final position, maintaining a deformed shape ([Fig. 3]) under pressure relative to its initial shape ([Fig. 2]). However, this application of pressure is optional, and the surgeon can also fix the dome in its final position without deforming it.

[0049] On the other hand, when the material chosen for the dome is radio-transparent, for example PEEK, the surgeon can 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 make, while being able, thanks to the fixing by the screws and the deformable nature of the wall of the dome, to add or remove biomaterial intended to form regenerated bone.

[0050] However, the present invention is not limited to these radio-transparent materials, and the barrier element may in particular be instead made of zirconium dioxide, titanium, magnesium or any other biocompatible material.

[0051] Preferably, the height of the dome, that is to say the distance perpendicular to its opening to its apex, is a function of the need for bone gain, generally on the order of 3 to 15 mm, in the dental field, while this length can be greater, on the order of several centimeters in the orthopedic or maxillofacial field.

[0052] In the embodiments shown here, the through-hole has a circular cross-section, which is particularly advantageous for ease of use, especially when the bone is harvested from the patient, and for ensuring a tight seal of the shell. However, the cross-section of the through-hole can have other shapes, for example elliptical or polygonal, for example square or hexagonal, particularly with rounded corners.

[0053] This application also describes a method for repairing bone by bone regeneration comprising the steps in which: - we take a kit according to the invention; - the barrier element is positioned around the bone to be repaired; - biomaterial is inserted into the space formed between the forming element barrier and the bone to be repaired, notably through at least one through opening; and - each through opening is plugged with a respective bone plug.

[0054] According to one embodiment, the barrier element is positioned around the bone to be repaired and fixed with the fixing means.

[0055] According to another embodiment, the barrier element is fixed after the biomaterial has been inserted into said space.

[0056] In the case where the barrier is made of a non-resorbable material, the barrier element is removed once the bone has regenerated.

Claims

Demands

1. Kit for bone regeneration, intended to form a barrier to protect a space above a surface of a bone, for example of the jaws, to allow, after insertion of a mineralizing biomaterial, the formation of new bone above the existing bone, comprising: - on the one hand an element (1; 10) forming a self-supporting barrier, for example in the form of a dome or a shell in a first material, pierced with at least one through opening (4; 40); and - on the other hand at least one plug (5; 50) in a second material, different from the first material, having shape and dimensions adapted to plug the through opening(s) (4; 40); the kit further includes means (2, 3; 20, 30) of fixation to fix the barrier element above the surface of the bone so as to form the space where the biomaterial is disposed to mineralize and form new bone by grafting to the previously present bone.

2. Kit according to claim 1, characterized in that the through opening or each through opening has a circular cross-section.

3. Kit according to claim 1 or 2, characterized in that the through opening or each through opening has a larger dimension of between 3 and 10 millimeters, in particular a diameter of between 3 and 10 millimeters.

4. Kit according to any one of the preceding claims, characterized in that the fixing means comprise perforations (20) formed in the barrier and one or more corresponding respective osteosynthesis screws (3; 30) disposed in the respective perforations, the largest dimension in width of the perforations, in particular their diameter, being less than 3mm, in particular in the order of 1 to 2mm.

5. Kit according to any one of the preceding claims, characterized in that the barrier element, apart from the through opening(s) and the means of fixation, is impermeable to gingival cells but can be permeable to ions, for example by having microperforations on all or part of its surface, the largest dimension in width of the microperforations, in particular their diameter, being on the order of 1 to 5 micrometers.

6. Kit according to any one of the preceding claims, characterized in that the barrier element has the shape of a shell or a dome.

7. Kit according to any one of the preceding claims, characterized in that the second material is bone material.

8. A bone regeneration device intended to form a barrier to protect a space above a bone surface, for example a tooth, to allow, after insertion of a biomaterial which, upon mineralization, will form new bone above the existing bone, consisting solely of a self-supporting barrier element, for example in the form of a dome 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 onto the previously existing bone, characterized in that the barrier element, for example in the form of a dome or a shell, has at least one through opening whose inscribed circle has a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters,and in particular the barrier element which does not include any closing cover for the through opening(s).

9. Device according to claim 8, characterized in that the fixing means comprise perforations (20) formed in the barrier and one or more corresponding respective osteosynthesis screws (30) disposed in the respective perforations, the largest dimension in width of the perforations, in particular their diameter, being less than 3mm, in particular in the order of 1 to 2mm.

10. Device according to claim 8 or 9, characterized in that the barrier element, apart from the through opening(s) and the means of fixing, is impermeable to gingival cells but can be permeable to ions, for example by having microperforations on all or part of its surface, the largest dimension in width of the microperforations, in particular their diameter, being on the order of 1 to 10 micrometers.

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