CN106580520A - Implant and method for manufacturing mandibular implant with PEKK (polyetherketoneketone) supporting and fixing units and tissue engineering growth unit - Google Patents
Implant and method for manufacturing mandibular implant with PEKK (polyetherketoneketone) supporting and fixing units and tissue engineering growth unit Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2803—Bones for mandibular reconstruction
- A61F2002/2807—Chin implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
Abstract
The invention provides an implant and a method for manufacturing a mandibular implant with PEKK (polyetherketoneketone) supporting and fixing units and a tissue engineering growth unit. The method includes steps: 1) image acquisition and three-dimensional model establishment; 2) molding unit and fixing unit design; 3) supporting unit design; 4) growth unit design; 5) individual composite-structure implant assembly; 6) individual composite-structure implant manufacturing; 7) in-vitro culture. A molding unit, fixing units, supporting units and the growth unit jointly form an individual composite-structure implant, the supporting units, the fixing units and the molding unit are made of PEKK materials and capable of providing sufficient mechanical strength to keep structural integrity from occlusion functional reconstruction, and the growth unit which is an internally degradable stent is capable of guiding new bone generation.
Description
Technical field
The present invention relates to mandible growth field, more particularly, to a kind of there is PEKK to support fixed cell and organizational project
The lower jaw bone implant manufacture method of growing element and implant.
Background technology
Mandibular bone is that volume and area are maximum in human body Maxillary region skeleton, is also the skeleton of facial uniquely energy activity,
Its as facial area profile main support structure, complex shape, and with extremely strong individuation feature.At present, wound, tumor are cut
Except the mandibular defect caused with malformation correction has become clinical common disease, after mandibular defect to the swallowing of patient,
The functions such as language, chewing can all produce impact, and cause facial deformity, reduce quality of life.
The main method for clinically repairing mandibular defect at present is to take bone implant in patient itself different parts to carry out
Skin grafing and mending, such as ilium, rib or fibula take bone., clinically using for many years, comparative maturity can be effective for this technology
Part recover patient oral cavity function and appearance.But due to new wound being brought to patient, being made taking bony site second operation
The Cranial defect of Cheng Xin, and implant bone amount and shape are all limited, it is difficult to recover the appearance of patient, particularly meshing functionss completely
Reconstruction it is undesirable, the later stage occlusion repair it is relatively difficult.
Another kind of method for repairing mandibular defect is customized metal implant.With digital prototype technology and metal
3D printing technique medical domain application, the design and fabrication technology of Individual Mandibular bone implant comparative maturity.Titanium
The 3D printing implant of alloy material clinically has been obtained for successfully after the biological treatments such as hydroxyapatite HA sprayings
Using.But the mechanical properties such as the elastic modelling quantity (110GPa) of metal material such as titanium alloy are than body bone tissue (cortical bone and pine
Matter flexible bone modulus is typically in 1-20GPa scopes) it is much higher, " stress shielding " effect is easily produced after implantation, cause surrounding
Atrophy, implant loosening of normal bone tissues etc., affect the effect of mandible reconstruction.So, metal implant is designed
When, need to reduce its intensity by designing loose structure, but which increase design and the difficulty for making.And metal material
Heat conductivity differs greatly with tissue, and the feeling of patient has significantly different.
Tissue engineering technique is another kind of thinking for repairing mandibular defect, i.e., using degradation material such as polycaprolactone
The porous support that PCL makes, after addition somatomedin and osteocyte, is fabricated to the organizational project bone implant of personalization, implantation
Defect is used for mandible growth.While scaffold degradation, guiding osteocyte grows into form new bone, until completely by itself bone
Tissue substitute.Bone tissue engineer reparation is the most preferable restorative procedure for Cranial defect.Because New born formation needs certain answering
Scaffold degradation process under force environment, but power effect is difficult control, easily subsides and causes New born formation and plastotype difficult；Simultaneously
Product after timbering material degraded easily causes untoward reaction.At present, it is mostly in basis using organizational project repairing bone defect
Conceptual phase, also has with a distance from suitable from real clinical practice.
PEKK (PolyEtherKetoneKetone, abbreviation PEKK) is a kind of special engineering plastics of excellent performance,
Good biocompatibility, can form good synosteosis with osseous tissue；The close aluminium alloy of its mechanical performance, elastic modelling quantity is low, corrosion resistant
Corrosion is close with nickel steel, with excellent rub resistance and abrasion resistance properties, its elastic modelling quantity in 4GPa or so, but than cortical bone
Intensity slightly lower (10-20GPa), after fibre reinforced, its modulus is up to 21GPa.At present, PEKK eats pencil by the U.S.
Reason office FDA is approved as body implanting material (being such as used for jaw bone implant material), with good biomedical applications prospect.But
Because PEKK material mechanical performances are more slightly lower than cortical bone, need to properly increase its mechanical property by structure design or enhancement techniques
Energy.
The content of the invention
In in order to solve current mandibular defect reparation, the increase that autologous bone transplanting is present supplies area new wound, bone amount not
Foot, plastotype are difficult, occlusal reconstruction considers not enough, and metal implant is transplanted, and the elastic modelling quantity for existing is too high, cause " stress screen
Cover " implant is loosened, or even the problems such as repairing failure, the invention provides one kind from meshing functionss reconstruction, have
Enough mechanical strength can be provided maintain the plastotype unit of the PEKK materials of structural intergrity, fixed cell and support unit,
And can guide the personalized composite construction implant that the growing element of the inside biodegradable stent of New born formation collectively constitutes
Manufacture method and implant.
The technical solution adopted for the present invention to solve the technical problems is：
A kind of manufacture method for supporting fixed cell and the lower jaw bone implant of organizational project growing element with PEKK, institute
The method of stating is comprised the following steps：
1) image acquisition and three-dimension modeling：
1. image acquisitions are carried out to mandible and by the image data storage of collection to storage device；
2. the mandible model of reconstruction patients：The Three-dimensional Gravity of mandible model is carried out according to the image data of mandible
Build, and determine the lesion region of mandible；
3. lesion region jawbone is amputated：According to the lesion region on three-dimensional mandible model, by the pathological changes of mandible
Region complete resection obtains defect area；
4. mirror image technology is utilized, the strong side of mandibular bone to be repaired is symmetric to into defect area, after constructing reparation
The initiating structure of complete mandibular bone and the composite construction implant isolated；
5. split the initiating structure of composite construction implant, according to the thickness of cortex of bone for measuring, be divided into cortical bone mould
Type and spongiosa bone model two parts；
2) plastotype unit and fixed cell are designed:
1. based on obtaining complete mandibular bone by mirror image technology, FEM (finite element) model is built, jaw muscle group will be risen with certain rigidity
Spring replace, apply gmatjpdumamicss on the initiating structure of composite construction implant, after carrying out FEM calculation, obtain it is complete under
The stress and strain distribution of jawbone, and the stress and strain distribution of the initiating structure of composite construction implant；
2. based on the cortex bone model in the initiating structure of composite construction implant, according to complete mandibular bone finite element
The stress distribution that analysis is obtained, based on the elastic modelling quantity of PEKK materials, determines the plastotype unit of composite construction implant
Thickness；
3. based on complete mandibular bone stress distribution, composite construction implant is determined according to the elastic modelling quantity of PEKK materials
Fixed cell thickness, by its elongation strain direction design fixed cell, the position of fixing hole need to avoid adjacent healthy tooth
Root of the tooth and mandible incisor；
3) support unit design：
1. the foundation of FEM (finite element) model
The cortex bone model of the initiating structure of composite construction implant, spongiosa bone model and fixed cell are completed into grid to draw
After point, corresponding bone material attribute and boundary condition are set, analysis step is set, apply corresponding Mechanical loading, complete finite element
The foundation of model；
2. topology optimization design
Using finite-element preprocessing software, using minimize flexibility as optimization aim, structural volume fraction as optimization pact
Beam condition, using density variable method topology optimization design is carried out, and obtains the support unit of composite construction implant；
4) growing element design
According to remaining spongiosa bone model after support unit is removed, corresponding 3D printer model and printed material are set
Afterwards, add pre-designed degradable multiporous cell cube, and reserve the position of mandible incisor, obtain degradable tissue work
The structural model of engineering support i.e. growing element；
5) assembling of personalized composite construction implant
Plastotype unit, support unit, fixed cell and growing element is combined, obtain personalized composite construction and plant
Enter body；
Further, the manufacture method is further comprising the steps of：6) making of personalized composite construction implant：
Plastotype unit, fixed cell and support unit adopt PEKK materials, growing element to adopt degradable high polymer material,
The silk material of bi-material controls respectively the temperature of two extruder heads by double extruder head 3D printer extrusions, and disposal molding goes out
Personalized composite construction implant；The personalized composite construction implant of printing need to be through surface sand-blasting process；
Further, the manufacture method is further comprising the steps of：7) In vitro culture and implantation:
Personalized composite construction is implanted and is added after nutritional labeling, somatomedin and osteocyte, trained in culture fluid
Support so as to bioactivation.
A kind of implant made based on described method for designing, including the plastotype unit for plastotype, for it is to be repaired
The growth list that fixed cell, the support unit for supporting gmatjpdumamicss and the guiding osteocyte that purgation again jawbone cheek side is fixed grows into
The shape identical tubular structure of the initiating structure of unit, the plastotype unit and composite construction implant, the support unit, life
Long unit is arranged in the plastotype unit, two ends, the support list of the plastotype unit along its elongation strain direction
Unit is equipped with the fixed cell along the two ends in its elongation strain direction, and a fixed cell is while the plastotype list with same one end
Unit and support unit connection, the support unit is fixedly connected with the inwall of plastotype unit, the left and right two ends of the growing element
Fit with mandibular bone two ends to be repaired section respectively；
The growing element is the loose structure that n degradable multiporous cell cube is formed, and n is the natural number more than 0, and n is individual
Degradable multiporous cell cube is respectively distributed in the space between the support unit and plastotype unit.
Further, the plastotype unit, support unit and fixed cell are made using PEKK materials, and growing element is adopted can
Degraded macromolecular material is made.
Further, the fixed cell follows closely affixed with mandibular bone cheek side to be repaired by titanium.
The present invention design concept be：In repairing for current mandibular defect, it is implanted into based on autologous bone implant, metal
Problem present in the recovery technique of body and tissue engineering bracket implant etc., the present invention rebuilds angle from meshing functionss,
Intend being based on PEKK materials, design and produce a kind of personalization with external support structure and interior tissue engineered biological structure and be combined
Structure implant；I.e. by the topological optimization algorithm in Engineering Structure Optimum, design one kind can provide implant primary stability,
For the supporting construction that internal biodegradable stent provides suitable support force and growing space；While the implant is can with inside
The loose structure of degradable material and the supporting construction for PEKK materials, guiding is new in the optimum stress environment that supporting construction is provided
Osteogenesis.
Beneficial effects of the present invention are mainly manifested in：Avoid and secondary injury is caused to patient after autologous bone transplanting, it is impossible to
Recover appearance completely, the problems such as meshing functionss rebuild undesirable；Metal implant is avoided simultaneously to producing " stress around affected part
Shielding " effect, causes the harmful effects such as atrophy, the implant loosening of surrounding normal osseous tissue；From meshing functionss reconstruction, draw
Enter the Topology Optimization Method in Engineering Structure Optimum, devise it is a kind of with enough mechanical strengths can be provided maintaining structure complete
The plastotype unit of whole property, fixed cell and support unit and can guide New born formation inside degradable growing element
The personalized composite construction implant for collectively constituting；PEKK materials, good biocompatibility is adopted to form good with osseous tissue simultaneously
Good synosteosis；The close aluminium alloy of its mechanical performance, elastic modelling quantity is low, and corrosion resistance is close with nickel steel, with excellent antifriction
Wipe and abrasion resistance properties, matched well can be reached with subjects bones, so as to improve reparation success rate, to improving patient facial region's
Form and profile, recover oral cavity masticatory function and have extraordinary effect.
Description of the drawings
Fig. 1 is Mandibular disease model schematic of the present invention.
Fig. 2 is mandibular bone non lesion regional model schematic diagram of the present invention.
Fig. 3 is the complete mandible model schematic diagram after the present invention is repaired, wherein 31 is the initial of composite construction implant
Structure, 32 is non-lesion region model.
Fig. 4 is cortical bone model schematic of the present invention.
Fig. 5 is spongy bone model schematic of the present invention.
Fig. 6 is the stress and strain distribution schematic diagram of complete mandibular bone.
Fig. 7 is the plastotype cell schematics of composite construction implant.
Fig. 8 is the plastotype unit and fixed cell assembling schematic diagram of composite construction implant.
Fig. 9 is the finite element analysis model schematic diagram of composite construction implant.
Figure 10 is the support of composite construction implant and fixed cell model schematic.
Figure 11 is the flowchart of the Topology Optimization Method for realizing personalized composite construction implant.
Figure 12 is that topological optimization of the present invention is embodied as flow chart.
Figure 13 is the growing element model schematic of composite construction implant.
Figure 14 is the model schematic of personalized composite construction implant.
Figure 15 is personalized composite construction implant cast and non lesion regional model assembling schematic diagram.
Specific embodiment
Below in conjunction with the accompanying drawings the invention will be further described.
It is a kind of to support fixed cell to be implanted into the mandibular bone of organizational project growing element with PEKK with reference to Fig. 1～Figure 15
The manufacture method of body is comprised the following steps：
1) image acquisition and three-dimension modeling:
1. image acquisitions are carried out to mandible.The collection of the data can be adopted by means such as CT/MRI
Collection.Illustrated with CT, can be scanned using spiral CT thin, in dicom format storage sets by layer data after scanning
It is standby.
2. the mandible model of reconstruction patients.The image data of mandible is imported to into Medical Image Processing software
In, such as the Mimics softwares of Materlise companies, the three-dimensional reconstruction of mandible model is carried out, and important anatomy structure is rebuild
Such as root of the tooth, mandible incisor analyze in software the lesion region 11 for determining patient, as shown in Figure 1.
3. lesion region jawbone is amputated.According to the lesion region 11 on three-dimensional mandible model, with reference to clinical diagnosis, most
The jawbone amputation scheme of patient is determined eventually.In design software, such as Magics softwares of Materlise companies, by patient's lower jaw
The lesion region complete resection of bone obtains defect area, as shown in Figure 2.
4. mirror image technology is utilized, the strong side of mandibular bone to be repaired is symmetric to into defect area, after constructing reparation
The initiating structure of complete mandibular bone and the composite construction implant isolated.As shown in Figure 3.
5. split composite construction implant initiating structure, according to the thickness of cortex of bone measured on CT images, be divided into skin
Matter bone model 112 and the two parts of spongiosa bone model 113, such as Fig. 4, shown in Fig. 5.
2) plastotype unit and fixed cell are designed:
1. based on obtaining complete mandibular bone by mirror image technology, FEM (finite element) model is built, jaw muscle group (masticatory muscless, temporo will be risen
Flesh, alary muscle) replaced with the spring of certain rigidity, apply gmatjpdumamicss on the initiating structure of composite construction implant, had
After limit unit calculates, the stress and strain distribution of complete mandibular bone, and the stress and strain distribution of reparation body region are obtained, wherein
The overall stress distribution of mandibular bone is as shown in Figure 6.
2. it is limited according to complete mandibular bone based on the cortical bone in the initiating structure of composite construction implant such as Fig. 4
The stress distribution that meta-analysis are obtained, based on the elastic modelling quantity of PEKK materials, determines the plastotype unit of composite construction implant
82 thickness H, as shown in Figure 7.
3. based on complete mandibular bone stress distribution, composite construction implant is determined according to the elastic modelling quantity of PEKK materials
Fixed cell 81 thickness, by its elongation strain direction design fixed cell 81, fixed cell is provided with several, fixed cell
On the position of fixing hole need to avoid the root of the tooth and mandible incisor of adjacent healthy tooth, as shown in Figure 8.
3) support unit design:
1. the foundation of FEM (finite element) model
Using finite-element preprocessing software, such as Hypermesh softwares of Altair companies, by the skin of implant initiating structure
Matter bone model, spongiosa bone model and fixed cell import Hypermesh softwares with IGES forms, it are completed after stress and strain model,
Corresponding bone material attribute (including Young's moduluss and Poisson's ratio) and boundary condition are set, analysis step is set, apply corresponding power
Loading is learned, the foundation of FEM (finite element) model is completed.FEM (finite element) model is as shown in Figure 9.
2. topology optimization design
Using finite-element preprocessing software, such as the Hypermesh softwares of Altair companies, to minimize flexibility to optimize mesh
Mark, structural volume fraction carry out topology optimization design as the constraints of optimization using density variable method, obtain composite construction plant
Enter the support unit 83 of body, as shown in Figure 10.Wherein support unit 83 is directly connected to fixed cell 81.
The Topology Optimization Method for realizing personalized composite construction implant realizes flow process as shown in figure 11, image acquisition and
System model is set up, the then foundation of FEM (finite element) model, topology optimization design, then bone remoulding simulation evaluation, can be with if evaluating,
Just it is composite construction implant, if evaluation is not all right, re-starts topology optimization design.
Topological optimization is embodied as flow chart as shown in figure 12, calls in FEM (finite element) model and initial parameter, into major cycle,
Finite element analyses solution is carried out, to minimize flexibility as optimization aim, then structural volume fraction is sentenced as optimization constraints
It is disconnected whether to meet required precision, required precision is met with regard to output result and visualization result, if being unsatisfactory for required precision, enter back into
Major cycle.
4) growing element design:
Using Industrial Design Software, such as the Auto Fab softwares of MARCAM ENGINEERING companies, by removing knot is supported
Remaining spongiosa bone model imports Auto Fab softwares with VFX forms after structure, arranges corresponding 3D printer model and prints material
After material, add pre-designed degradable multiporous cell cube and solve, and reserve the position of mandible incisor, obtain dropping
The structural model of solution tissue engineering bracket i.e. growing element 84, as shown in figure 13.
5) assembling of personalized composite construction implant:
Using design software, such as the Magics softwares of Materlise companies, by foregoing plastotype unit 82, support
Unit 83, fixed cell 81 and growing element 84 are combined, obtain personalized composite construction implant, as shown in figure 14.
6) making of personalized composite construction implant:
Plastotype unit, support unit and fixed cell use PEKK materials, and growing element degradable high polymer material is such as
Poly- caproate PCL, the silk material of bi-material controls respectively the temperature of two extruder heads by double extruder head 3D printer extrusions,
Disposal molding goes out personalized composite construction implant.The implant of printing need to be through surface sand-blasting, bioactivation such as hydroxyl carbon
The post processings such as lime stone spraying.
7) In vitro culture:
Personalized structured implant is added after nutritional labeling, somatomedin and osteocyte, is trained in culture fluid
Support so as to bioactivation.
Then the defect area of mandibular bone is implanted to by clinical operation, with the fixed fixed cell 81 of titanium nail, completes to repair
Operation, final repairing effect figure is as shown in figure 15.
A kind of implant made based on described method for designing, including the plastotype unit 82 for plastotype, for treat
Repair what fixed cell 81, the support unit 83 for supporting gmatjpdumamicss and the guiding osteocyte fixed mandibular bone cheek side grew into
The shape identical tubular structure of the initiating structure of growing element 84, the plastotype unit 82 and composite construction implant, it is described
Support unit 83, growing element 84 are arranged in the plastotype unit 82, and the plastotype unit 82 is along its elongation strain side
To two ends, the support unit 83 be equipped with the fixed cell 81, a fixation along the two ends in its elongation strain direction
Unit is connected with the plastotype unit and support unit of same one end simultaneously, and the support unit 83 is fixed with the inwall of plastotype unit 82
Connection, the left and right two ends of the growing element 84 fit respectively with mandibular bone two ends to be repaired section；
The growing element 84 is the loose structure that the degradable multiporous cell cubes of n are formed, and n is the natural number more than 0, n
Individual degradable multiporous cell cube is respectively distributed in the space between the support unit and plastotype unit.
The plastotype unit 82 is used to maintain the integrity of structure, and for internal biodegradable stent suitable support force is provided,
Growing space is provided for cell growth；The fixed cell 81 is used to provide the stability at implant initial stage；The support unit
83 are used to carry gmatjpdumamicss；The growing element 84 is used for attachment, propagation and the differentiation of cell, to meet and transport nutrient between tissue
Matter and metabolic waste, guide New born formation；The fixed cell follows closely affixed with the outer surface of mandibular bone cheek side to be repaired by titanium.
When using, the fixed cell 81 of whole personalized composite construction implant is fitted in into mandibular bone cheek side to be repaired
On, and two end sections of growing element 84 fit respectively with mandibular bone two ends to be repaired section, then by titanium nail will
Property composite construction implant is fixed on the defect area of mandibular bone to be repaired.
Claims (6)
1. a kind of manufacture method of the lower jaw bone implant for supporting fixed cell and organizational project growing element with PEKK, it is special
Levy and be：The method comprising the steps of：
1) image acquisition and three-dimension modeling：
1. image acquisitions are carried out to mandible and by the image data storage of collection to storage device；
2. the mandible model of reconstruction patients：The three-dimensional reconstruction of mandible model is carried out according to the image data of mandible,
And determine the lesion region of mandible；
3. lesion region jawbone is amputated：According to the lesion region on three-dimensional mandible model, by the lesion region of mandible
Complete resection obtains defect area；
4. mirror image technology is utilized, the strong side of mandibular bone to be repaired is symmetric to into defect area, constructed complete after repairing
The initiating structure of mandibular bone and the composite construction implant isolated；
5. split composite construction implant initiating structure, according to the thickness of cortex of bone for measuring, be divided into cortex bone model with
Spongiosa bone model two parts；
2) plastotype unit and fixed cell are designed:
1. based on obtaining complete mandibular bone by mirror image technology, FEM (finite element) model is built, by liter jaw muscle group with the bullet of certain rigidity
Spring replaces, and on the initiating structure of composite construction implant gmatjpdumamicss are applied, and after carrying out FEM calculation, obtains complete mandibular bone
Stress and strain distribution, and the initiating structure of composite construction implant stress and strain distribution；
2. based on the cortex bone model in the initiating structure of composite construction implant, according to complete mandibular bone finite element analyses
The stress distribution for obtaining, and determine the thickness of the plastotype unit of composite construction implant；
3. based on complete mandibular bone stress distribution, the thickness of the fixed cell of composite construction implant is determined, by its stretching
Should be changed direction design fixed cell, and the position of the fixing hole on fixed cell need to avoid the root of the tooth and lower jaw god of adjacent healthy tooth
Jing is managed；
3) support unit design：
1. the foundation of FEM (finite element) model
The cortex bone model of the initiating structure of composite construction implant, spongiosa bone model and fixed cell are completed into stress and strain model
Afterwards, corresponding bone material attribute and boundary condition are set, analysis step is set, apply corresponding Mechanical loading, complete finite element mould
The foundation of type；
2. topology optimization design
Using finite-element preprocessing software, using minimize flexibility as optimization aim, structural volume fraction as optimization constraint bar
Part, using density variable method topology optimization design is carried out, and obtains the support unit of composite construction implant；
4) growing element design
According to remaining spongiosa bone model after support unit is removed, after corresponding 3D printer model and printed material are set, add
Plus pre-designed degradable multiporous cell cube, and the position of mandible incisor is reserved, obtain degradable organizational project
The structural model of frame i.e. growing element；
5) assembling of personalized composite construction implant
Growing element is sleeved on outside support unit, plastotype unit is sleeved on outside growing element, fixed cell is simultaneously single with support
Unit, plastotype unit are connected, and obtain personalized composite construction implant.
2. manufacture method as claimed in claim 1, it is characterised in that：The method comprising the steps of：6) it is personalized compound
The making of structure implant：
Plastotype unit, fixed cell and support unit adopt PEKK materials, growing element to adopt degradable high polymer material, two kinds
The silk material of material controls respectively the temperature of two extruder heads by double extruder head 3D printer extrusions, and disposal molding goes out individual character
Change composite construction implant；The personalized composite construction implant of printing need to be through surface sand-blasting process.
3. manufacture method as claimed in claim 1 or 2, it is characterised in that：The method comprising the steps of：7) external training
Support：
Personalized composite construction is implanted and is added after nutritional labeling, somatomedin and osteocyte, cultivated in culture fluid, made
Its bioactivation.
4. the implant that a kind of manufacture method based on described in claim 1 makes, it is characterised in that：The implant includes using
Plastotype unit in plastotype, the fixed cell for fixing with mandibular bone cheek side to be repaired, the support list for supporting gmatjpdumamicss
Unit and the guiding growing element that grows into of osteocyte, the shape phase of the plastotype unit and the initiating structure of composite construction implant
Same tubular structure, the support unit, growing element are arranged in the plastotype unit, and the plastotype unit draws along it
The two ends in stretching strain direction, the support unit are equipped with the fixed cell along the two ends in its elongation strain direction, one
Fixed cell is connected with the plastotype unit and support unit of same one end simultaneously, and the support unit is fixed with the inwall of plastotype unit
Connection, the left and right two ends of the growing element fit respectively with mandibular bone two ends to be repaired section；
The growing element is the loose structure that n degradable multiporous cell cube is formed, and n is the natural number more than 0, and n can drop
Solution porous element body is respectively distributed in the space between the support unit and plastotype unit.
5. implant as claimed in claim 4, it is characterised in that：The plastotype unit, support unit and fixed cell are adopted
PEKK materials are made, and growing element is made using degradable high polymer material.
6. implant as claimed in claim 5, it is characterised in that：The fixed cell is followed closely and mandibular bone cheek to be repaired by titanium
Side is affixed.
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