A kind of skull repairing body and preparation method thereof inducing bone tissue regenerationTechnical field
The present invention relates to the field of medical instrument technology more particularly to it is a kind of induce bone tissue regeneration skull repairing body and itsPreparation method.
Background technique
As patient because the reasons such as brain trauma or intracranial disease carry out operation of opening cranium, it will usually cause skull defeci, skull lacksDamage so that brain tissue is lost protective barrier, be easy injury, when defect is larger more with such as giddy, headache, melancholy, irritability, impatience notThe symptoms such as peace, and beauty is influenced, it causes to patients ' psychological compared with major injury.It can be repaired by skull prosthesis and skull repairing bodyComplication is reduced, and restore the purpose of patient's appearance beauty to realize protection brain tissue in multiple skull defeci region.
Currently, the material for making skull repairing body mainly has natural biologic material and synthetic material two major classes.Natural biologic material is mainly derived from autologous bone, homogeneous allogenic bone and heterogenous allosome bone, draws materials limited, and that there are immunological rejections is anti-It the risks such as answers and infects, therefore be only limitted to the filled type implantation of skull small area defect.Synthetic material can be divided into metal materialMaterial and nonmetallic materials.Metal material includes tantalum, titanium alloy or stainless steel etc., and repairing is permanent implanted, long-term foreign matterStimulation may cause complication, and be easy to cause the teratogenesis of new bone.Nonmetallic materials include organic glass, bone cement andIts composite material etc., bone cement is irritating to brain tissue, and postoperative easily-deformable generation loosens, and organic glass intensity is small, frangible, easily oldChange and histocompatbility is poor.Chinese patent CN102490350A discloses a kind of side for using PEEK as material for repairing skullCase, PEEK has good biocompatibility and excellent mechanical performance, but it is a kind of bio-inert material, is unfavorable for thinThe adherency growth of born of the same parents' tissue, influences wound healing.
Summary of the invention
The technical purpose to be realized of the present invention is to provide a kind of mechanical strength and biocompatibility is high, and facilitates induction and lackDamage the skull repairing body and preparation method thereof of region bone tissue regeneration.
To achieve the goals above, the present invention provides a kind of skull repairing bodies for inducing bone tissue regeneration, from inside to outsideIt successively include interior inducing layer, supporting layer and outer inducing layer；
The supporting layer is made of poly aryl ether ketone material, grid-shaped structure, has multiple grid holes, each netCheckerwork cell is connected to the inner surface and the outer surface of the supporting layer, and is filled with bioactive materials；
The interior inducing layer and the outer inducing layer are made of bioactive materials, are respectively arranged on the interior of the supporting layerSurface and outer surface.
Preferably, the edge of the skull repairing body, the interior inducing layer and the outer inducing layer exceed institute outwardState supporting layer.
Preferably, the interior inducing layer is no more than 2mm beyond the distance of the supporting layer；The outer inducing layer is beyond describedThe distance of supporting layer is not less than 5mm.
Preferably, the thickness range of the skull repairing body is 3mm-12mm, and the thickness range of the supporting layer is 1mm-The thickness range of 4mm, the interior inducing layer and the outer inducing layer is 1mm-4mm.
Preferably, each grid hole is uniformly distributed, and the width range of the single grid hole is 0.5-2mm, adjacentThe spacing range of two grid holes is 2-3mm.
Preferably, the poly aryl ether ketone material is polyether-ether-ketone, polyether ketone ketone, polyether-ketone, polyether etherketone ketone or polyethersIn ether ketone ketone any one or at least two mixture.
Preferably, the bioactive materials are mineralized collagen, hydroxyapatite, calcium phosphate, collagen, polylactic acid, gather oneselfIn lactone or polylactide any one or at least two mixture.
The present invention also provides a kind of preparation methods of skull repairing body as described in above-mentioned first item, including following stepIt is rapid:
S1, the skull data for obtaining patient；
S2, using acquisition skull data carry out three-dimensional reconstruction, according to skull defeci position extract skull repairing body andThe mathematical model of supporting layer；
S3, the mathematical model according to supporting layer, using selective laser sintering 3D printing technique, with poly aryl ether ketone powderThe supporting layer of skull repairing body is printed for raw material；
S4, the mathematical model according to skull repairing body make the upper mold and lower mold of skull repairing body；
S5, the bioactive materials for preparing colloid or corpus mamillare；
S6, using upper mold obtained in step S4 and lower mold, the supporting layer printed in step S3 is embedded in stepIn the bioactive materials prepared in S5, the skull repairing body is made.
Preferably, the step S2 includes:
S2-1, by the skull data obtained in step S1 import medicine reverse software in, using threshold value by bone with it is softTissue segmentation extracts the bony areas of skull, and excludes the bone tissue not connecting with main body skull by region growing operation, completeAt the reconstructing three-dimensional model of skull；
S2-2, the threedimensional model of skull is imported into reverse engineering software, extracts the profile in the middle part of skull damaged part bone edgeContour line of the line as supporting layer repairs the upper and lower curved surface for the layer that is supported, and sutures the analog image for the layer that is supported；
S2-3, the grid hole that multiple connection upper and lower curved surfaces of supporting layer are drawn out in the analog image of supporting layer, are hadThere is the Preliminary Simulation body of the supporting layer of network；
S2-4, the threedimensional model according to skull, the 3-D image for extracting repairing damaged part is simulated as skull to be repairedBody image；
S2-5, the simulation of skull obtained in supporting layer Preliminary Simulation body steps for importing S2-4 obtained in step S2-3 is repairedIn complement image, it is overlapped the two, saves the surface model of supporting layer and skull repairing body；
S2-6, by surface model importing digital model engraving software obtained in step S2-5, referring to damaged part mirror imageThe Skull research of position adjusts the internal repair curved surface and external reparation curved surface of skull repairing body, makes damaged part and its mirror imageThe Skull research of position is consistent；
The curvature for adjusting supporting layer is consistent with the curvature of skull repairing body, and supporting layer is made to be in the interposition of skull repairing bodyIt sets；
The upper and lower curved surface of supporting layer is stitched into closed body, the mathematical model for the layer that is supported；By skull repairing bodyInternal repair curved surface and external curved surface of repairing are stitched into closed body, obtain the mathematical model of skull repairing body.
Preferably, further includes:
S7, pre-shaping step S6 obtain skull repairing body, make the supporting layer profile and skull damaged area bone of skull repairing bodyEdge coincide, and interior inducing layer and outer inducing layer exceed supporting layer.
Above-mentioned technical proposal of the invention has the advantages that the present invention provides one kind to have induction bone tissue regeneration functionThe skull repairing body of energy has three-decker, including interior inducing layer, supporting layer and outer inducing layer, with patient's endocranium and skinThe interior inducing layer and outer inducing layer bioactivity with higher of skin contact site and good biocompatibility, can promote and lureLead the regeneration of bone tissue.As interior inducing layer and outer inducing layer are gradually degraded, raw material can be provided and creeped for the regeneration of bone tissueStructure, new bone are grown along interior inducing layer and outer inducing layer, gradually substitute interior inducing layer and outer inducing layer.In the skull repairing bodyBetween supporting layer be poly aryl ether ketone material, good biocompatibility, in bioactivity suitable with human body bone strength, hardness, weightWhile material induces new osteanagenesis, supporting layer is always that skull repairing body provides mechanical support effect, persistently maintains mechanics strongDegree, protects brain tissue not by the injury of external force.Supporting layer is fenestral fabric, is equipped with multiple grid holes, filling in grid holeSelf-bone grafting layer substance, can promote the exchange of supporting layer ectendotrophy substance, be conducive to growing into for tissue.
The present invention also provides a kind of preparation methods of skull repairing body for inducing bone tissue regeneration, and this method is according to patientSkull data establish mathematical model, and using poly aryl ether ketone powder as raw material, printing obtains skull repairing body supporting layer, and makes mouldTool, supporting layer is embedded in bioactive materials, is obtained skull repairing body by filling mould, being compression molded into shape, is obtained skull reparationBody and patient's skull defect bone edge matching degree with higher, operation difficulty when reducing operation.
Detailed description of the invention
Fig. 1 is the skull repairing body vertical section schematic diagram that bone tissue regeneration is induced in the embodiment of the present invention one；
Fig. 2 is supporting layer fenestral fabric schematic diagram in the embodiment of the present invention one；
Fig. 3 is the preparation method flow chart that the skull repairing body of bone tissue regeneration is induced in the embodiment of the present invention two.
In figure: 1: interior inducing layer；11: internal repair curved surface；2: supporting layer；21: grid hole；3: outer inducing layer；31: externalRepair curved surface.
Specific embodiment
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with the embodiment of the present inventionIn attached drawing, technical scheme in the embodiment of the invention is clearly and completely described, it is clear that described embodiment isA part of the embodiments of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, ordinary skill peopleMember's every other embodiment obtained without making creative work, shall fall within the protection scope of the present invention.
Embodiment one
As shown in Figure 1, the embodiment of the present invention one provides a kind of skull repairing body for inducing bone tissue regeneration, including three layersStructure successively includes interior inducing layer 1, supporting layer 2 and outer inducing layer 3 from inside to outside.Wherein, supporting layer 2 is by mechanical strength and craniumThe comparable poly aryl ether ketone material of bone is made, as shown in Fig. 2, the grid-shaped structure of supporting layer 2, has multiple grid holes 21.RespectivelyA grid hole 21 is connected to the inner surface and the outer surface of supporting layer, and raw filled with can induce bone tissue in each grid hole 21Long bioactive materials.Interior inducing layer 1 and outer inducing layer 3 are made of the bioactive materials of inducible bone growth,It is respectively arranged on the inner surface and the outer surface of supporting layer 2.
In the prior art for repair of bone of cranium skull repairing body usually exist mechanical strength not enough, biocompatibility notThe problem of well or being unfavorable for cell tissue adherency growth.And the present invention provides a kind of skull reparations for inducing bone tissue regenerationBody is with higher with patient's endocranium and the interior inducing layer 1 at skin contact position, outer inducing layer 3 using three-deckerBioactivity and good biocompatibility bioactive materials, can promote and induce the regeneration of bone tissue.Its intermediate powerThe supporting layer 2 for learning supporting role is poly aryl ether ketone material, suitable with human body bone strength, hardness, weight.Skull repairing body dressAfter entering patient's skull defect, interior inducing layer 1, outer inducing layer 3 gradually degrade and tissue are promoted to grow, and replace biologyActive material, and supporting layer 2 is not involved in degradation, persistently maintains patient's skull mechanical strength always in replacement process, protects brainPortion's tissue is not by the injury of external force.Meanwhile supporting layer 2 is equipped with multiple grid holes 21, fills self-bone grafting layer in each grid hole 21Substance can promote the exchange of 2 ectendotrophy substance of supporting layer, be conducive to growing into for tissue, promote patient wound's healing.
Preferably, the edge of skull repairing body, interior inducing layer 1 and outer inducing layer 3 exceed supporting layer 2 outward, herein"outside" refer to far from each surface center of each layer structure.As shown in Figure 1, interior inducing layer 1 and outer inducing layer 3 are all larger than branchLayer 2 is supportted, the upper surface of interior inducing layer 1 is greater than the lower surface of supporting layer 2, and curved surface is to extending out along where the lower surface of supporting layer 2, outsideThe lower surface of inducing layer 3 is greater than the upper surface of supporting layer 2.The circumferential edge of interior inducing layer 1 and outer inducing layer 3 was at supporting layer 2 weeksThe projection of curved surface where to edge falls in the outside of 2 circumferential edge of supporting layer namely the upper surface contour line of interior inducing layer 1 surroundsOn the outside of the lower surface contour line of supporting layer 2, the lower surface contour line of outer inducing layer 3 surrounds the upper surface contour line of supporting layer 2Outside.
As shown in Figure 1, the U-shaped groove in the edge of the skull repairing body of the induction bone tissue regeneration may be stuck in damaged portionDivide at bone edge, help to fix the skull repairing body, it is avoided to move, misplace, so that supporting layer 2 and skull damaged partBone edge be in close contact, preferably to support skull.
It is further preferred that interior inducing layer 1 is no more than 2mm beyond the distance of supporting layer 2, i.e., interior inducing layer 1 is greater than supportThe lower surface contour line distance of of length no more than 2mm of 2 part of layer namely the upper surface contour line of interior inducing layer 1 and supporting layer 2No more than 2mm, avoids skull repairing body from can not be successfully and be caught in damaged part；Outer inducing layer 3 is not less than beyond the distance of supporting layer 25mm, namely the lower surface contour line of outer inducing layer 3 and the upper surface contour line distance of supporting layer 2 are not less than 5mm, to installWhen can be punched in outer inducing layer 3 beyond the part of supporting layer 2, be packed into fixing glue, fixing glue penetrates outer inducing layer 3 and be fixed on patientSkull bone edge, further fixes the position of the skull repairing body, skull repairing body is avoided to relatively move with patient's skull, rightTissue causes friction damage.
Preferably, to obtain better repairing effect, and ensure that the mechanical strength of skull repairing body is enough, skull repairing bodyThickness range be 3mm-12mm, the thickness range of supporting layer 2 is 1mm-4mm, is divided into the inside and outside interior inducing layer 1 of supporting layer 2Thickness range with outer inducing layer 3 is 1mm-4mm.
Preferably, each grid hole 21 being arranged on supporting layer 2 is uniformly distributed in the form of an array, the width of single grid holeRange is 0.5-2mm, and the spacing range of two neighboring grid hole 21 is 2-3mm, and spacing herein refers to two adjacent meshThe minimum range in hole 21, i.e. the distance between the two adjacent edge.Each grid hole 21 is preferably square, and is ensuring skull reparationIn the case where the mechanical strength of body, equably promote the exchange of 2 ectendotrophy substance of supporting layer.
The poly aryl ether ketone material for being preferably made from supporting layer 2 is polyether-ether-ketone, polyether ketone ketone, polyether-ketone, polyether etherketoneIn ketone or polyether ether ketone ketone any one or at least two mixture.
It is preferably made from interior inducing layer 1 and outer inducing layer 3, and the bioactivity material being filled in each grid hole 21Material be mineralized collagen, hydroxyapatite, calcium phosphate, collagen, polylactic acid, polycaprolactone or polylactide in any one orAt least two mixture.
Preferably, which is made according to patient's skull defect, and the upper surface of outer inducing layer 3 is outsideCurved surface 31 is repaired, the lower surface of interior inducing layer 1 is internal repair curved surface 11, skull repairing body entirety and patient's skull defectMatch.
Embodiment two
As shown in figure 3, the present embodiment two of the present invention provides a kind of preparation of skull repairing body for inducing bone tissue regenerationMethod is used to prepare the skull repairing body that bone tissue regeneration is induced described in above-described embodiment comprising following steps:
S1, the skull data for obtaining patient；
S2, using acquisition skull data carry out three-dimensional reconstruction, according to skull defeci position extract skull repairing body andThe mathematical model of supporting layer 2；Skull repairing body mathematical model herein is the skull repairing body overall digital mould for including supporting layer 2Type；
S3, according to the mathematical model of supporting layer 2, using selective laser sintering 3D printing technique, with poly aryl ether ketone powderEnd is the supporting layer 2 that raw material prints skull repairing body；
S4, the mathematical model according to skull repairing body make the upper mold and lower mold of skull repairing body；
S5, the bioactive materials for preparing colloid or corpus mamillare；
S6, using upper mold obtained in step S4 and lower mold, the supporting layer 2 printed in step S3 is embedded in stepIn the bioactive materials prepared in S5, skull repairing body is made.
A kind of preparation method of skull repairing body inducing bone tissue regeneration provided by the invention obtains patient's skull data,Mathematical model is established with this, and then obtains the skull repairing body to match with patient's skull defect, manufactured skull repairing body is notOnly help to induction bone tissue regeneration, and with skull defeci position bone edge matching degree with higher, reduce skull reparationSurgical procedure difficulty.
Preferably, in step S1 obtain patient skull data method be computed tomography, Magnetic resonance imaging,One of x-ray imaging, B ultrasound imaging, electronic imaging are several.On the data etch-recordable optical disk of acquisition or other can be storedIn equipment, DICOM format is saved as.
Preferably, when in step S2 according to the mathematical model of skull defeci position extraction skull repairing body and supporting layer 2,Specifically includes the following steps:
S2-1, by the skull data obtained in step S1 import medicine reverse software in, using threshold value by bone with it is softTissue segmentation extracts the bony areas of skull, and excludes the bone tissue not connecting with main body skull by region growing operation, completeAt the reconstructing three-dimensional model of skull.
Preferably, the medicine reverse software used in the step can be Mimics software or other same type softwares,Such as 3D-doctor, 3D-Med or 3D Slicer.
By taking Mimics software as an example, the skull data of DICOM format are imported with Mimics software, using threshold T, by boneBone and soft tissue are divided into bright and dark two class, the binarization segmentation of image are realized, to extract bone portion；According to the ladder of imageDegree information seeks its Grads threshold G, extracts the profile of tissue, is determining the skull bone region of level choosing needs as seed zoneThen domain clicks automated regional growth order, is automatically performed the reconstructing three-dimensional model of skull, exports the data file of STL format.
S2-2, the threedimensional model of skull is imported into reverse engineering software, extracts the profile in the middle part of skull damaged part bone edgeContour line of the line as supporting layer 2 repairs the upper and lower curved surface for the layer 2 that is supported, and sutures the analog image for the layer 2 that is supported.
Preferably, the reverse engineering software applied in the step include Imageware, Geomagic Studio,One of CopyCAD and RapidForm or a variety of.
By taking Imageware as an example, (STL formatted data) skull 3 D model obtained in step S2-1 is importedImageware software hands over the profile cut, in the middle part of the damaged skull bone edge of B-spline, the method for match point cloud extraction by command point cloudLine, as 2 contour line of supporting layer, save as IMW format.
Obtained IMW formatted data is imported into UG, by designing radian line, repairs to obtain with functions such as grid curvesThe upper and lower curved surface of supporting layer 2, will repair curved surface suture can be obtained the analog image of supporting layer 2.
S2-3, the grid hole 21 that multiple connection upper and lower curved surfaces of supporting layer are drawn out in the analog image of supporting layer 2, obtainTo the Preliminary Simulation body of the supporting layer 2 with network.
Supporting layer 2 is compiled as fenestral fabric by this step, it is preferable that draws width on 2 projection plane of supporting layerRange is the square or rectangular of 0.5-2mm, and it is 2- that the spacing range of multiple square or rectangulars is made by linear array3mm, by stretching, boolean the operation such as subtract, form grid hole 21 on supporting layer 2, each grid hole 21 is in the form of an array uniformlyDistribution, the width range of single grid hole 21 are 0.5-2mm, and the spacing range of two neighboring grid hole is 2-3mm, is supportedThe Preliminary Simulation body of layer 2 is saved into STL format.
S2-4, the threedimensional model according to skull, the 3-D image for extracting repairing damaged part is simulated as skull to be repairedBody image.
Preferably, using Geomagic Studio software that (STL formatted data) skull obtained in step S2-1 is three-dimensionalModel removes noise point, and the contour line of damaged part skull is extracted by removal point cloud or boundary curve, repairs function by broken holeCan, it chooses curvature repairing method and repairs broken hole, extract the 3-D image at repairing position, skull simulation repairing body figure can be obtainedPicture namely skull repairing body general image.
Skull mould obtained in S2-5, the Preliminary Simulation body steps for importing S2-4 by supporting layer 2 obtained in step S2-3In quasi- repairing body image, so that the two is overlapped, the surface model of supporting layer 2 and skull repairing body is saved.
Preferably, by 2 Preliminary Simulation body file steps for importing of (STL formatted data) supporting layer obtained in step S2-3In the simulation repairing image of skull obtained in S2-4, by operations such as characteristic point, alignment so that 2 Preliminary Simulation body of supporting layer and craniumBone simulates repairing body picture registration, deletes other in 2 Preliminary Simulation body file of supporting layer in addition to 2 Preliminary Simulation body of supporting layerImage (repairs the outside of skull repairing body 2 image of supporting layer (the upper and lower curved surface of supporting layer 2), skull simulation repairing body imageDouble-curved surface 31 and internal repair curved surface 11, the i.e. upper and lower curved surface of skull repairing body) and primordial skull bone defect image save togetherAt OBJ format, adjusted convenient for the details of next step.
S2-6, by surface model importing digital model engraving software obtained in step S2-5, referring to damaged part mirror imageThe Skull research of position adjusts the internal repair curved surface 11 and external reparation curved surface 31 of skull repairing body, makes damaged part and itsThe Skull research of mirror position is consistent；The curvature for adjusting supporting layer 2 is consistent with the curvature of skull repairing body, that is, adjusts supporting layerUpper (lower) curved surface is consistent with outer (interior) the portion reparation curved surface curvature of skull repairing body, and supporting layer 2 is made to be in the centre of skull repairing bodyPosition.The curved surface of supporting layer 2 is stitched into closed body, the mathematical model for the layer 2 that is supported.The inside of skull repairing body is repairedDouble-curved surface 11 and external curved surface 31 of repairing are stitched into closed body, obtain the mathematical model of skull repairing body.
Preferably, the optional ZBrush software of mathematical model engraving software in the step, referring to the surface model of OBJ formatThe Skull research of mirror position in the skull defeci image of file Central Plains, by different operation brushes to the outside of skull repairing bodyIt repairs curved surface 31 and internal repair curved surface 11 is adjusted, adjust its curvature, have a smooth surface transition it, with mirror positionSkull research is consistent.
By drawing the orders such as convex or indentation so that the curvature of supporting layer 2 and the curvature of skull repairing body are consistent, and make to supportLayer 2 is in the middle position of skull repairing body.Unit inch is changed to mm, refresh data size by modification dimensional units orderNew data size is exported STL format by ratio.
The STL format that export is obtained, imported into Geomagic Studio software, chooses skull repairing body and supportLayer 2, deletes other images.2 image of supporting layer is chosen, skull repairing body image is deleted, the upper and lower curved surface of supporting layer 2 is suturedAt closed body, STL format is exported as, the mathematical model for the layer 2 that is supported.
Skull repairing body is chosen, supporting layer 2 is deleted, it is by broken hole mending function, the internal repair of skull repairing body is bentFace 11 and external curved surface 31 of repairing are repaired integral, obtain the mathematical model of skull repairing body.
Preferably, 2 mathematical model of STL format supporting layer obtained in step S2-6 is imported into selective laser in step S3It is sintered 3D printer, prints to obtain the supporting layer 2 in skull repairing body to be implanted into the poly aryl ether ketone powder of rank as raw material.
Preferably, the upper mold and lower die of skull repairing body are made according to the mathematical model of skull repairing body in step S4When tool, skull repairing body mathematical model obtained in step S2-6 is subtracted by segmentation, offset entirety, extension, stretching, boolean,The operation of the overmoldeds such as precise curved surface, obtains the upper and lower mold data of skull repairing body entirety, exports IGS format.
According to obtained IGS formatted data, by machining, casting, mould punching, chemical method, Electrolyzed Processing orThe upper mold of the skull repairing body of entity is made under in the method that model compares one or more of pincers worker system of striking manufacture moldMold.Preferably, the upper surface of upper mold is plane, and lower surface is identical as the external reparation curved surface 31 of skull repairing body.Lower dieThe upper surface of tool is identical as the internal repair curved surface 11 of skull repairing body, and lower surface is plane, and flat with the upper surface of lower moldRow is convenient for pressing mold.Also, the contact surface of upper mold and lower mold needs fit like a glove, and form closed type chamber after guaranteeing pressurizationNot flash.
Preferably, when preparing the bioactive materials of colloid or corpus mamillare in step S5, following method production mine can be usedChange collagen colloid:
S5-1, collagen is dissolved in any one of hydrochloric acid, nitric acid or acetic acid, is configured to collagen acid solution, collagen is denseDegree is 5.0 × 10-5-5.0×10-3g/ml。
S5-2, the solution by calcium ions, be added 4.1 obtained in collagen acid solution, the additional amount of calcium ion is everyGram collagen corresponds to calcium ion 0.01-0.16mol.
S5-3, continue whipping step S5-2 acquired solution, be slowly added to the solution of phosphorus-containing acid ion, phosphate anionThe molar ratio of additional amount and the additional amount of calcium ion in step S5-2 is Ca/P=1/1-2/1.
S5-4, continue whipping step S5-3 acquired solution, NaOH solution is slowly added dropwise to pH value of solution=6-8, forms whiteSuspension mixed system.
S5-5, mixed system obtained in step S5-4 being stood into 24-120h, precipitation and separation simultaneously washes away foreign ion, withMixed system is concentrated afterwards, obtains mineralized collagen colloid.
Preferably, step S6 includes: the colloid or corpus mamillare for pouring into 1-3mm height in obtained lower mold in step s 4Bioactive materials are placed in freeze dryer to freeze 0.5h at -20 DEG C, take out and freeze real lower mold, by what is printed in step S3Supporting layer 2 is put into lower mold, after adjusting position, the bioactive materials of identical colloid or corpus mamillare is added again, and willIt is filled into the grid hole 21 of supporting layer 2, covers upper mold, and the upper and lower mold that lid closes integrally is put into freeze dryer -20It freezes 5h at DEG C, takes out upper mold, carry out vacuumizing freeze-drying until weight is no longer changed, lower mold is removed after drySkull repairing body can be obtained.
Preferably, skull repairing body preparation method further include: S7, pre-shaping step S6 obtain skull repairing body, make skull2 profile of supporting layer and skull damaged area bone edge of dummy coincide, and interior inducing layer 1 and outer inducing layer 3 exceed supporting layer2, i.e. the U-shaped groove of the circumferential edge of skull repairing body.It is further preferred that distance of the interior inducing layer 1 beyond supporting layer 2 is notMore than 2mm, outer inducing layer 3 is not less than 5mm beyond the distance of supporting layer 2.
The embodiment is the skull repairing body for obtaining circumferential edge first with mold releasability and exceeding skull damaged part, thenBy the finishing in step S7, the skull repairing body coincideing with patient's skull damaged part is obtained.Skull repairing body after finishingInterior inducing layer 1 and outer inducing layer 3 exceed supporting layer 2,2 profile of supporting layer and skull damaged area bone edge of skull repairing bodyMatch, as shown in Figure 1, the groove that skull repairing body is circumferentially U-shaped, when use can be caught at skull defeci, so that skull repairing bodyIt is not susceptible to move, avoids scratch tissue, while 2 profile of supporting layer of skull repairing body and skull damaged area bone edge coincide,Skull can be preferably supported, maintains mechanical strength during inducing bone growth, has the function that protect brain tissue.
In order to step S7 finishing before obtain circumferential edge exceed patient's skull damaged part range skull repairing body, oneKind preferred embodiment are as follows: when making the upper mold and lower mold of skull repairing body in step s 4, according to skull repairing bodyMathematical model the circumferential edge of skull repairing body entirety is expanded outward so that the upper mold and lower die of skull repairing bodyHas the skull repairing body circumferential direction profile produced greater than actually required.It, can be along the week of skull repairing body when modifying in the step s 7To cutting, interior inducing layer 1 and outer inducing layer 3 are modified, and makes the exposure of the supporting layer being embedded in bioactive materials 2.
Another preferred embodiment are as follows: when extracting the mathematical model of skull repairing body in step s 2, it is preferable thatAfter adjusting supporting layer 2 in step S2-6, inducing layer 1,3 corresponding region of outer inducing layer in skull repairing body are expanded outward, obtainedInterior inducing layer 1, outer inducing layer 3 exceed the skull repairing body mathematical model of supporting layer 2.Corresponding upper mold is obtained in step s 4When with lower mold, the thickness of lower mold is preferably more than the thickness of interior inducing layer 1.It is right in lower mold when demoulding in step s 6Answering the region of 2 profile of interior inducing layer 1 and supporting layer, there are stepped changes, according to the profile variations feelings of lower mold mesocrany bone repairCondition fills bioactive materials, and interior inducing layer 1, skull repairing body of the outer inducing layer 3 beyond supporting layer 2 is directly made.In stepWhen being modified in S7, rubbing down and small range trimming adjustment can be carried out along the circumferential of skull repairing body, obtain final skull repairing body.
Finally, it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention, rather than its limitations；AlthoughPresent invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that: it still may be usedTo modify the technical solutions described in the foregoing embodiments or equivalent replacement of some of the technical features；And these are modified or replaceed, technical solution of various embodiments of the present invention that it does not separate the essence of the corresponding technical solution spirit andRange.