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, for example in the form of a dome or a shell, made of a biocompatible, radiolucent material impermeable to gingival cells, for example PEEK; and on the other hand, at least one or more closure elements made of the same material as the barrier element; 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 abstract: 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 shell of radio-transparent material, in particular PEEK, 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:

[0005] on the one hand a self-supporting barrier element, for example in the form of a dome or a shell, made of a biocompatible, radiolucent material impermeable to gingival cells, for example PEEK; and

[0006] on the other hand at least one or more closing elements made of the same material as the barrier element;

[0007] the kit further comprising fastening means for fixing the barrier element above the bone surface to thus form the space where the biomaterial is ready to mineralize and form new bone by grafting onto the previously present bone.

[0008] By using a radiolucent material, particularly PEEK, the surgeon can drill one or more through-holes in the barrier, notably with a trephine, as needed, to introduce biomaterial into the space between the existing bone and the barrier. The biomaterial can then mineralize and form new bone by grafting to the existing bone. The radiolucency of the material allows the practitioner to easily choose the locations for drilling the holes. Furthermore, since PEEK is relatively flexible, this drilling process is facilitated.

[0009] According to a second aspect of the invention, it also 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:

[0010] on the one hand, a self-supporting barrier element, for example in the form of a dome or a shell, made of a biocompatible, radio-transparent material impermeable to gingival cells, for example PEEK, the barrier element being pierced with one or more through openings; and

[0011] on the other hand at least one or more closing elements in the same material as that of the barrier element, having shapes and dimensions adapted to close, in particular to block, the or each through opening;

[0012] the kit further comprising means for fixing 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 onto the previously present bone.

[0013] According to a third 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:

[0014] on the one hand, a self-supporting barrier element, for example in the form of a dome or a shell, made of a biocompatible, radio-transparent material impermeable to gingival cells, for example PEEK; and

[0015] on the other hand, perforation means intended to perforate the barrier element with one or more through openings, for example a drill bit, so as to obtain at least one or more closing elements made of the same material as that of the barrier element capable of closing, in particular blocking, the opening(s) through which each passage passes;

[0016] the kit further comprising means for fixing 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 onto the previously present bone.

[0017] Preferably, the through opening or each through opening and / or the closing element or each closing element has or have a larger dimension between 3 and 10 millimeters, in particular between 4 and 8 millimeters (mm).

[0018] Preferably, the inscribed circle of the opening or of each opening and / or of the closing element or of each closing element, that is to say the largest circle that can be virtually drawn in the opening or in the closing element, has a diameter of between 3 and 10 millimeters, in particular between 4 and 8 millimeters,

[0019] Preferably, the through opening or each through opening and / or the closing element 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.

[0020] 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.

[0021] 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%.

[0022] 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).

[0023] Other examples of suitable materials include polylactic acid (PLA) and polyglycolic acid (PGA), which are resorbable.

[0024] 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.

[0025] 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.

[0026] Preferably, the barrier element is self-supporting but is elastically deformable, particularly in compression and / or bending.

[0027] Preferably, the barrier element, with the through opening or each through opening closed by a respective closing element, forms a barrier to hermetically protect, preferably temporarily, the space above a surface of a bone, for example the jaws.

[0028] In particular, the barrier element is elastically deformable in compression, this compression capacity allowing for better bone formation.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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, made of radio-transparent material, in particular PEEK, and means for fixing the barrier element above the surface of the bone to thus form a volume where the biomaterial can be positioned 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, in particular of circular cross-section having a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters.

[0035] Preferably, the device comprises one or more closing elements intended to close, in particular to plug, the or each through opening in the same radio-transparent material, in particular PEEK.

[0036] Preferably, the barrier element, with the openings closed by the closing elements and outside the means of fixation, 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.

[0037] By way of example, embodiments of the invention are described, with reference to the drawings, in which:

[0038] Fig. 1 is a perspective view of a kit according to the invention;

[0039] 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;

[0040] Fig. 3 is a view similar to that of Fig. 2 in the installed position of the kit;

[0041] Fig. 4 is a perspective view of another kit.

[0042] 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.

[0043] These slots 2 are very fine, in particular on the order of 0.5 to 3 mm 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.

[0044] 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.

[0045] 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.

[0046] The kit further 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.

[0047] In the case where several through openings 4 are provided, a corresponding number of closing elements 5 are provided.

[0048] 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.

[0049] 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.

[0050] 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. In particular, 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 his choice according to his needs, in particular using a trephine.

[0051] The kit also includes a closure element 50 made of the same material, here PEEK.

[0052] 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.

[0053] In the case where several through openings 40 are provided, a corresponding number of PEEK closure elements 50 are provided.

[0054] 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.

[0055] 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.

[0056] Once the dome's interior volume is filled with the biomaterial R intended to grow, the surgeon closes 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 inside it 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.

[0057] 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 by X-ray 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.

[0058] 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.

[0059] 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.

[0060] The shapes and dimensions of the closure elements are adapted to those of the openings, and in particular are substantially the same, so that they can be inserted into the openings to close them, especially in cases where 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 the closure elements completely cover the openings and allow them to be fixed along the peripheral edge of the openings, notably with glue. They may also be slightly smaller so that the closure elements are located within the openings, fixed there by a seal, notably with glue.

[0061] 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 - we position the closing element(s) so as to close, in particular to block, the opening(s) through.

[0062] According to a favorable embodiment, the drilling of the opening or each opening is carried out after fixing the barrier element around the bone, in particular using a trepan.

[0063] According to another favorable embodiment, the drilling of the opening or each opening is carried out after positioning the barrier element around the bone, but before fixing it around the bone.

[0064] According to one embodiment, the barrier element is positioned around the bone to be repaired and fixed with the fixing means.

[0065] According to another embodiment, the barrier element is fixed after the biomaterial has been inserted into said space.

[0066] 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. A bone regeneration kit, intended to form a barrier to protect a space above a bone surface, for example 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 (1; 10), for example in the form of a dome or a shell, made of a biocompatible, radiolucent material impermeable to gingival cells, for example PEEK, and on the other hand at least one or more closure elements (5; 50) made of the same material as the barrier element, the kit further comprising means (2, 3; 20, 30) for fixing the barrier element above the bone surface to thus form the space where the biomaterial is disposed to mineralize and form new bone by grafting to the previously existing bone.

2. Kit for bone regeneration according to claim 1, characterized in that the barrier element is pierced with one or more through openings (4; 40), the closing element(s) (5; 50), made of the same material as the barrier element, having shapes and dimensions adapted to close, in particular to plug, the through opening(s).

3. Kit for bone regeneration according to claim 1 or 2, 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).

4. Kit according to claim 1, 2 or 3, characterized in that the through opening(4; 40) and / or the closing element(5; 50) has a larger dimension of between 3 and 10 millimeters, in particular between 4 and 8 millimeters (mm).

5. Kit according to claim 4, characterized in that the inscribed circle of the opening or each opening (4; 40) and / or of the closing element or each closing element (5; 50), i.e., the largest circle that can be virtually drawn in the opening or in the closing element, has or have a diameter between 3 and 10 millimeters, particularly between 4 and 8 millimeters.

6. Kit according to claim 5, characterized in that the opening or each opening (4; 40) through and / or the closing element or each element (5; 50) is or are of circular cross-section, and preferably their diameter is between 3 and 10 millimeters, in particular between 4 and 8 mm.

7. 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.

8. 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%.

9. 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).

10. 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, comprising a self-supporting barrier element (1; 10), for example in the form of a dome or a shell, made of radiolucent material, in particular PEEK, and means (2, 3; 20, 30) 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 hull, includes at least one through opening (4; 40) 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 section having a diameter between 3 and 10 millimeters, in particular between 4 and 8 millimeters.

11. Device according to claim 10, characterized in that the device comprises one or more closing elements (5; 50) intended to close, in particular to plug, the or each through opening in the same radio-transparent material, in particular PEEK.

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