• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The present invention relates to a synthesis block intended to fill a bone defect, characterized in that it is constituted by a piece (11) of ceramic material which has a shape enabling it to come to fill the bone defect and which is suitable for be stabilized once in place in said bone defect, a three-dimensional network of channels communicating with each other being formed at least in part in said part (11) to pass the fluids and cells allowing revascularization for the purpose of cell growth once said piece (11) in place in the bone defect, said channels opening on each surface of the bone defect in contact with said piece (11) once in place in the bone defect.
    公开号:FR3026937A1
    申请号:FR1459765
    申请日:2014-10-10
    公开日:2016-04-15
    发明作者:Richard Gaignon；Christophe Chaput；Pontcharra Landry De
    申请人:3DCeram SAS；
    IPC主号:
    专利说明:

    [0001] The present invention relates to a synthesis block for filling a bone defect on the surface of a bone, as well as to a method of manufacturing this synthesis block. SUMMARY OF THE INVENTION . In particular, the bone defect treated according to the invention is a bone defect appearing in the bone of a mandible or maxilla. However, the invention is not limited to such bone defects. The bone volume of the maxillae is an essential factor for the placement of implants, namely artificial roots for the replacement of missing teeth. At present, when the bone volume is insufficient, it is possible: for small volumes, to use fillers in the form of granules or paste of synthetic origin (tricalcium phosphate beta, hydroxyapatite), human or animal (bovine, porcine, equine): such an application constitutes Guided Bone Regeneration (GOR); For large volumes, it is necessary to make apposition grafts with blocks of human origin (bone bank), animal or synthetic, or with bone blocks of the operated patient, autografted by symphyseal sampling, ramic or parietal.
    [0002] These known techniques present difficulties because the aforesaid blocks pose problems of shape and quantity. Indeed, they are of standard size and therefore need to be retailled intraoperatively (during 3026937 2 operation) to adapt them as best as possible to the bone defect. It follows: stability problems because the blocks and the bone defect are never perfectly joined; risk of fracture by flip-flop of the block at the time of osteosynthesis (fixation by screw); problems of osseointegration (block colonization by bone cells and formation of neovessels) and therefore rejection of the block; border problems too sharp with a risk of damage to the soft tissues (covering tissues, gingiva, epithelium, connective tissue) therefore poor tissue cicatrization yet essential; soft tissue sutures should provide complete and stress-free sealing to hope for osseointegration of the block; for autografts, there is the problem of a second operative site with the resulting consequences (ramus sampling, the symphysis of the chin, or general anesthesia at the parietal bone or at the hip); for autografts there is also the problem of the quantity that can be taken. The present invention aims to overcome these disadvantages. For this purpose, according to the invention, it is proposed to carry out by the technique by additive methods that can also be called stereolithography or 3D printing - synthetic blocks of ceramic material 30 perfectly adapted to the bone defects of patients, this making it possible to respond to different difficulties with current techniques.
    [0003] Indeed, being produced by 3D printing (stereolithography) from the scanner data of the patient (STL files), the block is perfectly adapted to the defect: 5 one removes the states of intraoperative retouching, difficult and not without risk for the block ; the problem of adaptation of the block to the bone defect is eliminated; a better seal is obtained, hence a close contact between the block and the blood bone cells; the body of the block is made with a sufficient "porosity" allowing colonization of the bone cells and neovascularization (manufacture of 15 new blood vessels); wells are placed at specific locations for the passage of one of several stabilization screws (osteosynthesis); it is especially necessary to strengthen the block at the level of the support of the screw heads and the chamfer and the diameter of these holes is adapted to the diameter of the screws to avoid creating a tension and fractures of the block when tightening the -this ; the composition of the ceramic material block is essential to have a total partial programmed resorption of the block and its total or partial replacement by the neoformed patient's bone; indeed the operator must re-intervene on the site operated after the end of complete bone healing to come to implement the implant or implants for which the increase in bone volume of the mandible or maxillary was necessary; - the problems encountered with autografts (second operating site and quantity removed) are obviously totally excluded. The present invention therefore firstly relates to a synthesis block intended to fill a bone defect on the surface of a bone, characterized in that it consists of a piece of ceramic material which has a shape enabling it to fill the bone defect and which is able to be stabilized once in place in said bone defect, a three-dimensional network of channels communicating with each other being formed at least partly in said room to pass the fluids and cells allowing revascularization in view of the cell growth once said piece in place in the bone defect, said channels opening on each surface of the bone defect in contact with said piece once in place in the bone defect. The ceramic material is advantageously a ceramic material that is at least partially absorbable.
    [0004] The ceramic material is especially chosen from tricalcium phosphate beta (R-TCP), hydroxyapatite and mixtures thereof in all proportions, being in particular composed, for 100% by weight, of 40 to 100% by weight of hydroxyapatite and from 60 to 0% by weight of 13-TCP. A common mixture consists of 60% by weight of hydroxyapatite and 40% by weight of 13-TCP. 13-TCP is absorbable whereas hydroxyapatite is not. The three-dimensional network of channels may be of any form in that it allows revascularization by the penetration of the fluids and cells necessary for this revascularization; there may be mentioned in particular the cubic mesh networks, the 5 channels then extending along each of the edges of the cubic mesh network. The ceramic part may carry externally at least one stabilizing eyelet intended to be applied against the surface of the bone to be restored, externally to said bone defect, said stabilization eyelet having no revascularization channels and being pierced with at least one hole for the passage of at least one stabilizing screw, and / or said ceramic piece may be pierced with at least one through hole, from the surface intended to come into contact with the delimiting bone said bone defect at the free surface, considering the position of the piece in place in the bone defect, for the passage of at least one stabilizing screw, said piece having no revascularization channels in the regions surrounding said hole at least in the adjacent portion of said free surface. Advantageously, the part does not have 20 revascularization channels in the region of its free surface if one considers its position in place in the bone defect. The channels forming the revascularization system may be of any section, for example circular, square, triangular, rhombic, with shapes having the greatest number of angles (cross-shaped for example). In particular, the channels forming the revascularization system may have a square section whose side is 250 to 600 μm with a tolerance of 200 μm. The channels forming the revascularization system advantageously have an upper section in the region of the part intended to be in contact with the bone delimiting the bone defect, being in particular channels of square section of 400 to 600 μm with a tolerance of 200 μm, the core channels of the coin being smaller square-section channels; alternatively, the density of the channels forming the revascularization system may be greater in the region or regions of the room intended to be in contact with the bone defect. The ceramic material composing the part has an intergranular microporosity, measured by mercury porosimetry, of 5 to 30% by volume, the micropores having a size of 0.1 to 10 μm. This microporosity is specific to the ceramic material manufactured. It is interesting that: - the heart of the piece has a structure closest to the "porous" and soft trabecular bone; the outer periphery of the piece (considered in its position in place in the bone defect) has a structure that is as close as possible to the characteristics of the cortical bone: dense and rigid; and the part of the part intended to come into contact with the patient's bone is very "porous" to allow revascularization as quickly as possible. Above described by "porous" or "porous" the presence of the channel network as defined above. Indeed the outer periphery of the part has the same structure as the rest of the room, with the microporosity inherent in the manufacturing process. The present invention also relates to a method for manufacturing a synthesis block as defined above, characterized in that it comprises the following steps: a three-dimensional image of the bone of a patient with the bone defect that one wants to fill; a computer model of the synthesis block whose shape corresponds to the bone defect, which comprises the revascularization channels and whose dimensions are slightly larger than said bone defect, is constructed by computer-aided design to take into account the withdrawal of the ceramic during the manufacture of the synthesis block; modifying this computer model of synthesis block, by computer-aided design, so that it can be ensured the stabilization of said synthesis block in said bone defect; and the desired synthesis block is manufactured by stereolithography or 3D printing. The method of manufacturing the piece of ceramic material as defined above generally comprises the steps of: forming, on a rigid support or on a part during manufacture, a first layer of a photocurable composition comprising at least one minus a ceramic material and a photocurable monomer; - curing the first layer of the photocurable composition by irradiation in the pattern defined for said layer, forming a first stage; forming, on the first stage, a second layer of the photocurable composition; - curing the second layer of the photocurable composition by irradiation in the pattern defined for said layer, forming a second stage; - optionally repeat said steps to obtain a part in the green state; 3026937 8 clean the part in the green state to remove the uncured composition; optionally disrupting the part in the cleaned raw state; 5 - sinter the piece in the raw state cleaned and optionally debonded, to obtain the finished part. In a particular embodiment of the process, the part is manufactured by stereolithography in a liquid process, the photocurable composition being liquid and the rigid support being a platform immersed in a bath of photocurable composition, and each of the layers is formed. of the photocurable composition by lowering the platform in the photocurable composition bath such that the upper stage of the workpiece being manufactured is lowered below the free surface of the photocurable composition, and each of the photocurable composition layers by laser scanning said free surface according to the pattern defined for said layer.
    [0005] In another particular embodiment of the process, the porous structure is produced by passthrough stereolithography, the photocurable composition being pasty and the photocurable composition is fed to the upper stage of the workpiece being produced and the photocurable composition for forming each of the photocurable composition layers, and each of the photocurable composition layers is cured by laser scanning said layer according to the pattern defined for said layer.
    [0006] The present invention also relates to the use of a synthesis block as defined above or manufactured by the method as defined above as a synthesis block intended to fill a bone defect of a mandible. or a maxilla. To better illustrate the object of the present invention, will be described below, for information and without limitation, several embodiments with reference to the accompanying drawing. In this drawing: - Figure 1 is a schematic perspective view of the healthy mandible of an adult man; - Figure 2 is a view of the body of the mandible of Figure 1 with a bone defect; Figure 3 is a schematic side view of a block intended to fill this bone defect, block according to a first embodiment of the invention; Figure 4 is a schematic top view of the block of Figure 3; - Figure 5 is a view corresponding to Figure 2 after implementation and stabilization of the synthesis block according to the first embodiment of the invention; Figure 6 is a view corresponding to Figure 5 after resorption of the synthesis block material and replacement by the patient's bone and placement of artificial roots; Figures 7 to 10 are front views of a maxillary respectively the healthy state; after loss of the incisal block; after setting up a synthesis block according to the first embodiment of the present invention; and after complete bone healing and placement of dental implants; 11 and 12 are views corresponding to FIGS. 3 and 4, respectively, showing a synthesis block made in accordance with a second embodiment of the present invention, the fastening screws used with this second embodiment having been shown in FIGS. in these Figures 11 and 12; Fig. 13 is a cross-sectional view of the synthesis block on the first or second embodiment to describe a possible structure thereof; Figure 14 is a top view of a mandible portion having a bone defect filled with a synthesis block according to the second embodiment of the invention; and Figure 15 shows, on a larger scale, a longitudinal sectional view of the synthesis block of Figure 14, for the purpose of describing the structure thereof. On the anatomical schematic views of the drawings, for the sake of clarity, the soft tissues: gingiva, muscles, cheeks, etc., and the vascular system were excluded, only the hard tissues: bones and teeth appearing. With reference to FIG. 1, it can be seen that the mandible 1 of an adult man has been represented with his body 2 and his two branches 3. The body 2 bears the teeth 4 of the lower dental arch, these being embedded in the cells carved in the spongy alveolar edge of the mandible body. In the drawing, the teeth have not been accurately represented, the objective of the invention being to present a synthesis block intended to fill a bone defect and its placement therein. The teeth involved here were numbered by their position relative to the middle of the mandible, namely: 5: second premolar; 6: first molar; 7: second molar; 8: third molar or wisdom tooth FIG. 2 shows the mandible body after loss of teeth 6, 7 and 8, and associated alveolar bone. The resulting bone defect has the shape of a trough extending from one side wall to the other of the mandible body.
    [0007] The piece of ceramic material 11 intended to fill this defect 10 is shown in FIGS. 3 and 4. It comprises a body 12 which has a shape enabling it to perfectly fit the defect 10, and which externally carries three eyelets 13 in the example shown, namely two eyelets on one side and one of the other. The eyelets 13 are intended to be applied against the respective lateral walls of the mandible 25 as can be seen in FIG. 5. They each comprise a hole 14 for the passage of an osteosynthesis screw making it possible to stabilize the workpiece. 11 is in place in the defect 10. The axis of the holes 14 is oriented to obtain the desired orientation of the osteosynthesis screws in order to attach the eyelets 13 for a perfect stabilization of the part 11. Similarly, the eyelets 13 are positioned on the body 12 of the part 11 to ensure such stabilization.
    [0008] In Figure 6, there is shown the mandible 1 after resorption of the ceramic material of the part 11 and replacement by the bone of the patient. After healing, placement of dental implants 15 is made possible.
    [0009] The structure of the workpiece 11 will be described hereinafter with reference to FIG. 13. FIGS. 7 to 10 correspond to the views 1, 2, 5 and 6, respectively, for a maxillary 16: FIG. 7 represents a front view of the maxillary 16 10 bearing the teeth 17 of the upper dental arch; Figure 8 shows the corresponding front view with loss of the four incisors and bone loss, creating the bone defect 18; 9 shows the piece 19 of ceramic material 15 according to the invention whose body 20 has filled the bone defect and the eyelets 22 have been applied against the front wall of the maxillary, allowing the passage of osteosynthesis screws through the corresponding holes 22; and Figure 10 shows the frontal view of the maxillary after complete bone healing and placement of the four dental implants on which the new teeth 24 have been placed. Figures 11 and 12 are views corresponding to Figures 3 and 4 respectively. but with another embodiment of the workpiece stabilizing means 11. In this embodiment, through-holes or holes 25 are drilled through the workpiece 11 (two bores 25 in the example shown) for the passage of the osteosynthesis screw 26 (shown in Figures 11 and 12) to penetrate into the patient's bone delimited by the bone defect 10. On the opposite, each bore 25 is flared in a chamfered portion 27 for the 3026937 13 housing the corresponding screw head 28. The positioning and orientation of the axes of the screws 26 are chosen to ensure good stabilization of the workpiece 11 for successful revascularization.
    [0010] Referring to Figure 13, it can be seen that the workpiece 11 may have two types of "porosity", namely: a main part 11a in which the three-dimensional network of revascularization channels is formed of channels of square section for example from 250 to 600 pm +/- 200 pm side; and a surface portion 11b which does not have a revascularization network, and therefore without channels (with only the microporosity) for a better resistance.
    [0011] As indicated above, the portion 11a could have a denser network or with larger channel sections in its region of contact with the patient's bone for accelerated revascularization. Figures 14 and 15 show a part 11 according to the second embodiment which has three different regions as to its "porosity": - a core portion 11A in which the three-dimensional network of revascularization channels is formed of square section channels for example 250-350 pm 25 +/- 200 pm side; a part 11B intended to come into contact with the patient's bone, in which the three-dimensional network of vascularization channels is denser or is formed of channels of square cross-sectional area larger than the channels of part 11A, by example of 400 to 600 pm +/- 200 pm side; and a surface portion 11C surrounding the holes 25 which does not have a revascularization network, hence without channels (with only the microporosity) for better resistance. The structure according to the invention can be manufactured according to any method of manufacturing layer by layer of the ceramic material. By way of example of such methods, mention may be made of rapid prototyping, and in particular stereolithography. This method is known to those skilled in the art, and for a detailed description thereof, reference is made to US5496682 or EP1472081. Briefly, in pasted stereolithography, a paste having, for example, the following composition (in% of the total mass) is prepared: ceramic 80 photopolymerizable binder 11.51 photoinitiator 0.09 dispersant 1.1 plasticizer 7.3 Ceramic here is hydroxyapatite or 13, - TCP or a mixture of both. The photopolymerizable binder may be an acrylate resin such as di-ethoxylated bisphenol A dimethacrylate or 1,6-hexanediol diacrylate. The photoinitiator will be selected from photoinitiators commonly used in the polymerization of acrylates. In particular, 2,2'-dimethoxy-2-phenylacetophenone and 2-hydroxy-2-methyl-1-phenylpropan-1-one are mentioned. The dispersant is preferably a phosphoric ester. As plasticizer can be chosen one or more agents from the group consisting of the family of glycols (eg polyethylene glycol), the family of phthalates (eg dibutyl phthalate), glycerol.
    [0012] In a pasty stereolithography apparatus, the paste is first spread on a platform to form a first layer of uniform thickness. This first layer is irradiated by laser scanning according to the pattern defined for the layer. The first layer of dough is cured by photopolymerization of the dough, except in the areas corresponding to the channels, which are not irradiated by the laser. A second layer of paste is then spread on the first hardened layer. This second layer is irradiated by laser scanning according to the pattern defined for the layer. The second layer of dough is thus cured, by photopolymerization of the dough, except in the areas corresponding to the channels. These operations are repeated to form the following stages.
    [0013] Each of the formed layers has a thickness of 25 to 100 μm, especially 50 μm; it goes without saying that the number of layers depends on the part manufactured. After photopolymerization of the last layer, the green part thus formed is cleaned to remove the unpolymerized composition. The cleaned green part is subjected to heat treatment (debinding) and then to sintering. It is understood that the embodiments which have been described above have been given as indicative and non-limiting and that modifications can be made without departing from the scope of the present invention.
    权利要求:
    Claims (10)
    [0001]
    CLAIMS1 - Synthesis block intended to fill a bone defect (10; 18) on the surface of a bone, characterized in that it is constituted by a piece (11) of ceramic material which has a shape allowing it to be filled the bone defect (10; 18) and which is capable of being stabilized once in place in said bone defect (10; 18), a three-dimensional network of channels communicating with each other being formed at least partly in said part (11) for passing fluids and cells allowing revascularization for cell growth once said piece (11) in place in the bone defect (10; 18), said channels opening on each surface of the bone defect (10; 18) in contact with said piece (11) once in place in the bone defect (10; 18).
    [0002]
    2 - synthesis block according to claim 1, characterized in that the ceramic material is a ceramic material at least partly absorbable.
    [0003]
    3 - synthesis block according to one of claims 1 and 2, characterized in that the ceramic material is selected from tricalcium phosphate beta ((3-TCP), hydroxyapatite and mixtures thereof in all proportions, being in particular composed, for 100% by weight, of 40% to 100% by weight of hydroxyapatite and 60% to 0% by weight of 3, -TCP.
    [0004]
    4 - synthesis block according to one of claims 1 to 3, characterized in that the piece (11) ceramic externally carries at least one stabilizing eyelet (13) intended to be applied against the surface of the bone to be restored, externally to said bone defect (10; 18), said stabilization eyelet (13) having no revascularization channels and being pierced with at least one hole (14) for the passage of at least one stabilizing screw, and / or said ceramic piece (11) is pierced with at least one through hole (25), from the surface intended to come into contact with the bone delimiting said bone defect (10; ) to the free surface, considering the position of the piece (11) in place in the bone defect (10; 18), for the passage of at least one stabilizing screw (26), said piece (11) ) not having revascularization channels in the regions surrounding said hole (25) at least in the portion adjacent to said free surface.
    [0005]
    5 - synthesis block according to one of claims 1 to 4, characterized in that the piece (11) has no revascularization channels in the region of its free surface if we consider the position of the room (11) in place in the bone defect (10; 18).
    [0006]
    6 - synthesis block according to one of claims 1 to 5, characterized in that the channels forming the revascularization system have a square section whose side is 250 to 600 pm with a tolerance of 200 pm.
    [0007]
    7 - synthesis block according to one of claims 1 to 6, characterized in that the channels forming the revascularization system have an upper section in the region of the part (11) intended to be in contact with the bone defining the bone defect (10; 18), being in particular square section channels of 400 to 600 pm side with a tolerance of 200 pm, the channels of the heart of the room being smaller square section channels, or the density of the channels forming the revascularization system is greater in the region or regions of the part (11) intended to be in contact with the bone defect (10; 18). 3026937 18
    [0008]
    8 - synthesis block according to one of claims 1 to 7, characterized in that the ceramic material component part (11) has an intergranular microporosity of 5 to 30% by volume, the 5 micropores having a dimension of 0, 1 to 10 pm.
    [0009]
    9 - A method of manufacturing a synthesis block as defined in one of claims 1 to 8, characterized in that it comprises the following steps: one acquires a three-dimensional image of the bone of a patient presenting the bone defect (10; 18) that one wants to fill; a computer model of the synthesis block whose shape corresponds to the bone defect (10; 18), which comprises the revascularization channels and whose dimensions are slightly larger than said bone defect, is constructed by computer-aided design. 18) to take into account the removal of the ceramic during the manufacture of the synthesis block; This computer block computer model is modified by computer-aided design so that stabilization of said synthesis block in said bone defect (10; 18) can be ensured; and the desired synthesis block is manufactured by stereolithography or 3D printing.
    [0010]
    10 - Use of a block of synthesis as defined in one of claims 1 to 8 or manufactured by the method as defined in claim 9 as a dental block intended to fill a bone defect (10; 18) of a 30 mandible or maxillary.
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    同族专利:
    公开号 | 公开日
    US10639156B2|2020-05-05|
    WO2016055752A1|2016-04-14|
    US20170304056A1|2017-10-26|
    EP3203934A1|2017-08-16|
    JP2019155121A|2019-09-19|
    JP2017536216A|2017-12-07|
    FR3026937B1|2021-10-01|
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    法律状态:
    2015-06-25| PLFP| Fee payment|Year of fee payment: 2 |
    2016-04-15| PLSC| Search report ready|Effective date: 20160415 |
    2016-10-28| PLFP| Fee payment|Year of fee payment: 3 |
    2017-08-23| PLFP| Fee payment|Year of fee payment: 4 |
    2018-08-14| PLFP| Fee payment|Year of fee payment: 5 |
    2019-08-28| PLFP| Fee payment|Year of fee payment: 6 |
    2020-05-15| CD| Change of name or company name|Owner name: S.A.S 3DCERAM-SINTO, FR Effective date: 20200407 |
    2020-10-26| PLFP| Fee payment|Year of fee payment: 7 |
    2021-09-29| PLFP| Fee payment|Year of fee payment: 8 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1459765A|FR3026937B1|2014-10-10|2014-10-10|SYNTHESIS BLOCK INTENDED TO FILL A BONE DEFECT AND ITS MANUFACTURING PROCESS|FR1459765A| FR3026937B1|2014-10-10|2014-10-10|SYNTHESIS BLOCK INTENDED TO FILL A BONE DEFECT AND ITS MANUFACTURING PROCESS|
    JP2017538465A| JP2017536216A|2014-10-10|2015-10-12|Synthetic block for bone defect compensation and manufacturing method thereof|
    US15/517,562| US10639156B2|2014-10-10|2015-10-12|Synthetic block intended for filling in a bone defect and method for manufacturing same|
    EP15801894.5A| EP3203934A1|2014-10-10|2015-10-12|Synthetic block intended for filling in a bone defect and method for manufacturing same|
    PCT/FR2015/052748| WO2016055752A1|2014-10-10|2015-10-12|Synthetic block intended for filling in a bone defect and method for manufacturing same|
    JP2019084876A| JP2019155121A|2014-10-10|2019-04-26|Synthetic block for filling in bone defect and method for manufacturing same|
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