Kit for bone regeneration and device forming part of such a kit

Abstract

A kit for bone regeneration, intended to form a barrier for protecting a space above a surface of a bone, for example of the jawbones, to make it possible, after insertion of a mineralizing biomaterial, to form new bone above the bone already present, comprising: on the one hand, a self-supporting barrier element, for example in the form of a dome or a shell; and, on the other hand, at least one or more closure elements; the kit further comprising fastening means for fastening the barrier element above the surface of the bone in order thereby to form the space where the biomaterial is arranged to mineralize and form new bone by grafting to the bone previously present.

Description

Bone regeneration kit 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 from other tissues, particularly 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 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 shell in radio-transparent material, in particular PEEK, and means of fixing the barrier element above the surface of the bone to thus form the volume where the biomaterial can be placed to mineralize and form new bone grafting to the bone previously present.

[0003] From US2018 / 0193149, a bone regeneration membrane is known in the form of a rectangular parallelepiped pocket with an opening on its top, opposite the entire extent of the area to be regenerated. A flap can be folded over to cover this opening, leaving the lateral sides partially open. Since the dimensions of the opening are the same as those of the area to be regenerated, in the case of a tooth, it is greater than 1 cm.

[0004] US5824088 describes a flat plate for covering a cavity formed in bone to be regenerated. This plate consists of a reinforcing metal grid and a covering membrane in the form of one or more layers supported by the metal grid. The plate as a whole is solid, without any through-holes. The grid has very small, microscopic perforations that allow the layer to pass through. forming the cover membrane can be applied to it in the form of a solution.

[0005] The present invention aims to improve prior art devices by providing a barrier 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.

[0006] According to a first aspect, the invention relates to a 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 a self-supporting barrier element, for example in the form of a dome or a shell; and on the other hand at least one or more closure elements; the barrier element being pierced with at least one through opening having a larger dimension, in particular a diameter, between 3mm and 10mm, the closure element or each closure element being of a suitable size to close, in particular plug, the opening or each opening;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 placed to mineralize and form new bone by grafting onto the previously present bone.

[0007] According to a first favorable embodiment, the barrier element is made of a biocompatible material, radio transparent and impermeable to gingival cells, for example PEEK, and the closure element or elements are made of the same material.

[0008] By using a radiolucent material, particularly PEEK, the surgeon is given the ability to create one or more through-holes in the barrier element, notably with a trephine, depending on their needs, to introduce biomaterial through these through-holes. The space formed between the existing bone and the barrier element allows the biomaterial to mineralize and form new bone by grafting onto the existing bone. The material's radiolucency makes it easy for the practitioner to choose the locations for drilling the openings. Furthermore, PEEK's relatively low rigidity facilitates this drilling process.

[0009] According to a second favorable embodiment, the barrier element is made of a first material, in particular impermeable to gingival cells, for example PEEK, Zirconia, Titanium or any other biocompatible non-resorbable or resorbable material such as Magnesium or similar, and the closure element or elements are made of a second material, different from the first material, in particular having an impermeability to gingival cells which deteriorates faster than that of the first material, in particular in bone matter.

[0010] The bone constituting the material of the closure element, 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, in particular for a sufficient time to allow new bone formation, 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 newly formed bone, without the gingival cells being able to pass through, thus accelerating bone formation.

[0011] According to another aspect of the invention, 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, in particular made of a biocompatible, radiolucent material impermeable to gingival cells, for example PEEK; and on the other hand, means of perforation intended to perforate the barrier element with one or more through openings, for example a trepan, so as to obtain at least one or more closure elements in the same material as that of the barrier element, suitable for closing, in particular plugging the through opening or each one; the kit further comprising means of fixing 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 bone previously present.

[0012] Preferably, the through opening(s) and / or the closing element(s) has a larger dimension, in particular diameter ± between 3 and 10 millimeters, especially between 4 and 8 millimeters (mm).

[0013] Preferably, the inscribed circle of the opening(s) and / or of the closing element(s), i.e. the largest circle that can be virtually drawn in the opening or in the closing element, has a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters,

[0014] Preferably, each through opening and / or each closing element is or are of circular section, and preferably their diameter is between 3 and 10 millimeters, in particular between 4 and 8mm.

[0015] In 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 micro-perforations on all or part of its surface, the largest dimension in width of the micro-perforations, in particular their diameter, being on the order of 1 to 5 micrometers.

[0016] According to a favorable embodiment, the material of the barrier element, for example in the shape of a dome or shell, and of the closure element(s) is made of a material, in particular non-absorbable, such that the barrier element 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%.

[0017] According to a particularly preferred embodiment, the non-absorbable material of the barrier element and of the closure(s) is a polyaryletherketone (PAEK), in particular a polyetheretherketone (PEEK) or a polyetherketoneketone (PEKK).

[0018] Other examples of suitable materials include polylactic acid (PLA) and polyglycolic acid (PGA), which are resorbable.

[0019] 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.

[0020] 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.

[0021] Preferably, the barrier element is self-supporting but elastically deformable, particularly in compression and / or bending.

[0022] Preferably, at least one through opening is formed in the lateral part of the barrier element, in particular not formed in the top part facing the area to be regenerated.

[0023] Preferably, the barrier element, with the through opening or openings closed by a respective closing element, forms a barrier to hermetically protect, preferably temporarily, the space above a bone surface, for example the jaws.

[0024] In particular, the barrier element is elastically deformable under compression, this compression capacity allowing for better bone formation.

[0025] This allows for the most precise shaping of the volume in which bone regeneration is desired, resulting in a bone volume that closely matches the surgeon's initial objective. Furthermore, the barrier element can easily be produced using 3D printing, machining, or similar techniques.

[0026] In particular, the biomaterial in which the barrier element is formed has a Young's modulus between 2 and 20 GPa, especially between 2 and 15 GPa, more particularly between 2 and 5 GPa, especially between 3 and 4 GPa.

[0027] 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 equal to substantially 180 MPa.

[0028] 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.

[0029] The above values ​​of resistance and Young's modulus are given at room temperature, i.e. between 20 and 25 °C, specifically at 23°C and under atmospheric pressure.

[0030] 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, the bone of a tooth, to allow, after insertion of a biomaterial which, upon mineralization, will form new bone above the existing bone, comprising a self-supporting barrier element, for example in the form of a dome or a shell, for example made of a radio-transparent material, in particular PEEK, 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, comprises at least one through-opening whose largest dimension is between 3 and 10mm, in particular whose inscribed circle (largest circle that can be drawn virtually in the opening) has a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters, in particular of circular section having a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters.

[0031] According to a favorable embodiment, the device includes one or more closure elements intended to close, in particular to plug, the or each through opening in the same material, in particular radio-transparent, in particular PEEK, Zirconia, Titanium or any other biocompatible non-resorbable or resorbable material such as Magnesium or similar.

[0032] According to another favorable embodiment, the device comprises one or more closure elements intended to close, in particular to plug, the or each through opening, the barrier element being made of a first material, in particular impermeable to gingival cells, for example PEEK, Zirconia, Titanium or any other biocompatible non-resorbable or resorbable material such as Magnesium or similar and the or each closure element is made of a second material, different from the first material, in particular having an impermeability to gingival cells which deteriorates faster than that of the first material, in particular bone material.

[0033] Preferably, the barrier element, with the openings closed by the closure elements and excluding the means of fixation, is impermeable to gingival cells but permeable to ions and nutrients, for example by having micro-perforations on all or part of its surface, the largest dimension in width of the micro-perforations, in particular their diameter, being on the order of 1 to 10 micrometers, preferably 1 to 5 micrometers.

[0034] By way of example, embodiments of the invention are described, with reference to the drawings, in which:

[0035] Figure 1 is a perspective view of a kit according to the invention;

[0036] Figure 2 is a schematic cross-sectional view of the barrier element from the kit in Figure 1 positioned over a bone before its installation;

[0037] Figure 3 is a view similar to that of Figure 2 in the installed position of the kit;

[0038] Figure 4 is a perspective view of another kit;

[0039] Figure 5 is a perspective view of a kit according to the invention;

[0040] Figure 6 is a schematic cross-sectional view of the barrier element from the kit in Figure 5 positioned over a bone before its installation;

[0041] Figure 7 is a view similar to that of Figure 6 in the installed position of the kit;

[0042] Figure 8 is a perspective view of another kit.

[0043] In Figure 1, the kit shown comprises a dome 1, for example made of PEEK, with a thickness of 0.5 mm, although this thickness can be between 0.1 mm and 1 mm. Four sliding slots 2 (only two are visible in the figure) extend approximately vertically, near the opening of the dome, which is located opposite the apex of the dome. Each sliding slot 2 is designed to receive a corresponding screw 3, which can slide within its respective slot. The slots and screws together form fastening means for securing the dome-shaped barrier element around a bone to be regenerated.

[0044] These slits 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 15mm.

[0045] On the other hand, there is formed in the dome 1 at least one circular through opening 4, with a diameter greater than the dimension of the slots 2 in their width, in particular with a diameter between 3 and 10mm, in particular between 4 and 8mm.

[0046] 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.

[0047] The kit also includes a PEEK closure element 5 with a shape complementary to the through opening 4 so as to be able to close, preferably completely, in particular to block, the opening 4.

[0048] In the case where several through openings 4 are provided, a corresponding number of closing elements 5 are provided.

[0049] 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, although this thickness may be 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 perforation 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.

[0050] 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.

[0051] In another embodiment, two through-holes could be provided, in particular diametrically opposed, or more than two through-holes, in particular three or four through-holes, distributed, in particular regularly, over the surface of the dome. Specifically, it could be provided that the surgeon, starting from a shell without an opening 40, drills the opening or several openings at the locations of their choice according to their needs, in particular using a trephine 60.

[0052] The kit also includes a 50 closure element in the same material, in this case PEEK.

[0053] The dimensions and shapes of the closing element 50 are such that when it is positioned in the opening of the window 40, the latter is closed, in particular blocked.

[0054] In the case where several through openings 40 are provided, a corresponding number of PEEK closure elements 50 are provided.

[0055] In both 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 small enough to prevent gingival cells from passing through the wall; specifically, these microperforations are circular in shape and have a diameter between 1 and 5 micrometers.

[0056] As shown in the figures, 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 from other tissues, will form new bone in the volume protected by the dome by associating with the surface of bone B.

[0057] Once the dome's interior volume is filled with the biomaterial R intended for growth, the surgeon seals the through-opening(s) 4 or 40 with its respective closing element 5 or 50. The surgeon can then also apply pressure to the dome to compress the biomaterial R within it and, using screws 3 or 30, fix the dome in its final position, maintaining a deformed shape (Figure 3) under pressure relative to its initial shape (Figure 2). However, this application of pressure is optional, and the surgeon can also fix the dome in its final position without deforming it.

[0058] On the other hand, since 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, and on the other hand, if he starts from a shell without an opening, drill the through opening(s) according to his needs.

[0059] Preferably, the height of the dome, that is to say the distance perpendicular to its opening to its apex, depends on 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.

[0060] 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 cavity. However, the cross-section of the through-hole can have other shapes, for example elliptical or polygonal, or even square or hexagonal, particularly with rounded corners.

[0061] The shapes and dimensions of the closure elements are adapted to those of the openings, and are essentially the same, so that they can be inserted into the openings to close them, particularly when the openings have been created by the surgeon, notably using a trephine. The shapes and dimensions of the closure elements may also be slightly larger so that they completely cover the openings and allow them to be fixed along the peripheral edge of the openings, for example with adhesive. Alternatively, they may be slightly smaller so that the closure elements are located within the openings and are fixed there with a seal, for example with adhesive.

[0062] This application also presents 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 barrier element and the bone to be repaired, notably via at least one through-hole; and - we position the closing element(s) so as to close, in particular to block, the opening(s) through.

[0063] In a favorable embodiment, the drilling of the opening or each opening is carried out after fixing the barrier element around the bone, in particular with the aid of a trepan.

[0064] According to another favorable embodiment, the drilling of the opening or openings is carried out after positioning the barrier element around the bone, but before fixing it around the bone.

[0065] According to one embodiment, the barrier element is positioned around the bone to be repaired and fixed with the fixing means.

[0066] According to another embodiment, the barrier element is fixed after the biomaterial has been inserted into said space.

[0067] In cases where the barrier is made of a non-resorbable material, the barrier element is removed once the bone has regenerated.

[0068] In Figure 5, the kit shown comprises a dome T, for example made of PEEK, with a thickness of 0.5 mm, although this thickness can be between 0.1 mm and 1 mm. Four sliding slots 2' (only two are visible in the figure) extend approximately vertically, near the opening of the dome, which is located opposite the apex of the dome. Each sliding slot 2' is designed to receive a corresponding screw 3', which can slide within its respective slot. The slots and screws together form fastening means for securing the dome-shaped barrier element around a bone to be regenerated.

[0069] These 2' slots 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 15mm.

[0070] On the other hand, there is formed in the dome 1' at least one circular through opening 4', with a diameter greater than the dimension of the slots 2 in their width, in particular with a diameter between 3 and 10mm, in particular between 4 and 8mm.

[0071] 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.

[0072] The kit also includes a 5" bone plug.

[0073] The bone forming the plug 5' could have been taken from the patient, notably as a core sample obtained with a trephine, or 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.

[0074] In the case where several 4' through openings are planned, a corresponding number of 5' bone plugs are planned.

[0075] Figure 8 shows another kit according to the invention. In Figure 8, the kit shown comprises a dome 10', for example made of PEEK, having a thickness of 0.5 mm, although this thickness may be 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's opening, opposite the apex of the dome, the perforations being regularly distributed along the circumference of the dome's free edge. Each perforation 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.

[0076] 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.

[0077] 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.

[0078] The kit also includes a 50' bone stopper.

[0079] The bone used for plug 50' could be harvested from the patient, notably using a trephine 60', in the form of a core sample, or obtained from a bone bank. The dimensions and shape of plug 50' are such that when positioned in the opening of window 40', the latter is completely sealed.

[0080] In the case where several 40' through openings are planned, a corresponding number of 50' bone plugs are planned.

[0081] In both embodiments shown in Figures 5 and 8, respectively, each T or 10' dome may include microperforations allowing neovascularization to access the biomaterial from the tissues, in addition to that from the native bone. However, these microperforations are small enough to prevent gingival cells from passing through the wall; specifically, these microperforations are circular in shape and have a diameter between 1 and 5 micrometers.

[0082] As shown in the figures, the T or 10' domes 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 the T dome with sliding slots, bone biomaterial, which, by mineralizing under the protection of the dome from other tissues, will form new bone in the volume protected by the dome by associating with the surface of bone B.

[0083] Once the dome's interior volume is filled with the biomaterial R intended for growth, the surgeon seals the 4' or 40' through-hole(s) with their respective 5' or 50' plugs. The surgeon can then also apply pressure to the dome to compress the biomaterial R within it and, using the 3' or 30' screws, fix the dome in its final position, maintaining a deformed shape (Figure 6) under pressure relative to its initial shape (Figure 5). However, this application of pressure is optional, and the surgeon can also fix the dome in its final position without deforming it.

[0084] 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.

[0085] However, the present invention is not limited to these radio-transparent materials, and the barrier element may instead be made of zirconium dioxide, titanium, magnesium, or any other biocompatible material.

[0086] 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.

[0087] 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 cavity. However, the cross-section of the through-hole can have other shapes, for example elliptical or polygonal, or even square or hexagonal, particularly with rounded corners.

[0088] This application also presents 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 barrier element and the bone to be repaired, notably via at least one through-hole; and - each through opening is plugged with a respective bone plug.

[0089] According to one embodiment, the barrier element is positioned around the bone to be repaired and fixed with the fixing means.

[0090] According to another embodiment, the barrier element is fixed after the biomaterial has been inserted into said space.

[0091] In cases where the barrier is made of a non-resorbable material, the barrier element is removed once the bone has regenerated.

Claims

Demands

1. 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; and on the other hand at least one or more closure elements; the barrier element being pierced with at least one through opening having a larger dimension, in particular a diameter, between 3mm and 10mm, the closure element(s) being of a suitable size to close, in particular plug, the opening or each opening;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 placed to mineralize and form new bone by grafting onto the previously present bone.

2. Kit for bone regeneration according to claim 1, characterized in that the barrier element is made of a biocompatible, radio-transparent material impermeable to gingival cells, for example PEEK, and the closure element or elements are made of the same material.

3. Kit for bone regeneration according to claim 1, characterized in that the barrier element is made of a first material, in particular impermeable to gingival cells, for example PEEK, Zirconia, Titanium or any other biocompatible non-resorbable or resorbable material such as Magnesium or similar, and the closure element or elements are made of a second material, different from the first material, in particular having an impermeability to gingival cells which deteriorates faster than that of the first material, in particular in bone matter.

4. Kit for bone regeneration according to claim 1 to 3, characterized in that it comprises perforation means intended to perforate the barrier element with one or more through openings, for example a trephine, so as to obtain the closing element(s), made of the same material as the barrier element, suitable for closing, in particular plugging the through opening(s).

5. Kit according to any one of claims 1 to 4, characterized in that the through opening or each through opening and / or the closing element or each closing element has or have a larger dimension of between 4 and 8 millimeters (mm).

6. Kit according to claim 5, characterized in that the inscribed circle of the or of each opening and / or of the or each closing element, i.e. the largest circle that can be drawn virtually in the opening or in the closing element, has or have a diameter of between 3 and 10 millimeters, in particular between 4 and 8 millimeters.

7. Kit according to any one of claims 1 to 5, characterized in that the through opening or each through opening and / or the closing element or each closing element is or are of circular section.

8. 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.

9. Kit according to any one of the preceding claims, characterized in that the material of the barrier element, for example dome-shaped or shell-shaped, and of the closure element(s) is made of a material, in particular non-absorbable, such that the barrier element 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%.

10. Kit according to any one of the preceding claims, characterized in that the non-absorbable material of the barrier element and of the closure(s) is a polyaryletherketone (PAEK), in particular a polyetheretherketone (PEEK) or a polyetherketoneketone (PEKK).

11. Kit according to any one of the preceding claims, characterized in that at least one through opening is formed in the lateral part of the barrier-forming element, in particular is not formed in the top part facing the area to be regenerated.

12. Barrier element intended to be part of a kit according to one of the preceding claims.

13. A bone regeneration device intended to form a barrier to protect a space above a bone surface, for example, a tooth bone, to allow, after insertion of a biomaterial which, upon mineralization, will form new bone above the existing bone, comprising a self-supporting barrier element, for example in the form of a dome or a shell, made of radio-transparent material, in particular PEEK, 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, comprises at least one through opening whose largest dimension is between 3 and 10 mm,in particular 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, in particular of circular cross-section having a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters.

14. Device according to claim 13, characterized in that the device comprises one or more closure elements intended to close, in particular to plug, the or each through opening in the same material, in particular radio-transparent, in particular PEEK, Zirconia, Titanium or any other biocompatible non-resorbable or resorbable material such as Magnesium or similar.

15. A device according to claim 13, characterized in that the device comprises one or more closing elements intended to close, in particular to plug, the through opening(s), the barrier element being made of a first material, in particular impermeable to gingival cells, for example PEEK, Zirconia, Titanium or any other biocompatible non-resorbable or resorbable material such as Magnesium or similar and the closure element(s) is made of a second material, different from the first material, in particular having an impermeability to gingival cells which deteriorates faster than that of the first material, particularly in bone matter.

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