CN1368386A - Process based on fast shaping for preparing bio-active artificial bone - Google Patents
Process based on fast shaping for preparing bio-active artificial bone Download PDFInfo
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Abstract
A process based on fast shaping technique for preparing biological active artificial bone includes such steps as creating CAD 3D internal microstructure and external shape model of bone by CT data, fast shaping the microstructure and the negative mould of its external shape, implantating biological factors or cells, adding Ti fibres for reinforcing mechanism property, filling biological bone material, and preparing artificial substitute bone. Its advantages are high individual adaptibility, high preparing speed good biological compatibilility and high survival rate after implanlation.
Description
One, technical field
The invention belongs to the medical recovery project in manufacturing field, the composite manufacturing method of the active skeleton of particularly a kind of artificial bio-membrane based on rapid shaping.
Two, background technology
A variety of causes such as disease, accident and war have caused a large amount of human body wounds, and wherein the damage to skeleton makes many people become deformity and lose basic viability.This has all brought great influence for patient's family and society.How to help the sclerous tissues of patient's repair deficiency or disappearance, recovering the human body hard tissue function better is the problem that medical circle is being explored always.From the biocompatibility angle, it is ideal that the homologue of getting patient self is made the material of damaged tissue repair, but this has not only increased infection chance, and the bone source is also restricted.Adopt allograph bone (animal bone and people's corpse),, antigenicity is arranged, also have social problem etc.,, be used for the reparation of tissue and organ and function in an acting capacity of its function so people just begin to develop the artificial material that can replace patient autologous tissue though the bone source problem is solved.In medical circle, researcher has been made the replacement bone implant into body with artificial material (plastics, metal, pottery), and this method can solve the reparation of the damaged skeleton of bulk.Medically use ceramic material manufacture of intraocular skeletons such as hydroxyapatite, calcium carbonate at present, but utilize these material manufacture artificial bones all need make complicated mould, or carry out expensive post-production.Because it is long to exist the replacement bone manufacturing cycle, product category is few, and size, shape can not meet patient's multiple reasons such as practical situation fully, and its repairing effect is not satisfactory.The rapid prototyping technique of develop rapidly both at home and abroad is expected to address these problems at present.
Rapid prototyping technique (Rapid Prototyping ﹠amp; Manufacturing, be called for short RPM) be to adopt the material forming principle that adds up, need not cutter, frock, form 3D solid by number of ways, it can turn materially the direct finished parts of the product prototype with certain structure function with design philosophy with the fastest speed, thereby product design and development may be estimated fast, test, improve, manufacture and design process to finish, meeting the market requirement, be a kind of development of manufacturing direction that is rich in vitality, and rapid prototyping technique unit of being suitable for or small lot batch manufacture, manufacturing cycle is short, do not need complicated mould just can reach the form factor of degree of precision.
The quick forming method of having developed at present mainly contains photocuring method (Stereolithography), layered manner (LOM), sintering process (SLS), fusing process of intermediate (FDM), 3D print process (3D-Printer) etc.
Do not possess enough intensity owing to be used for the biodegradable bioactive materials of rapid shaping manufacture method at present without sintering, all need sintering so general rapid shaping prepares the method for artificial bone.High temperature sintering makes the skeletal growth factor cell not survive.So the skeletal growth factor cell generally is after adopting sintering, the active skeleton of the artificial bio-membrane after solidifying is soaked in the liquid that contains the skeletal growth factor cell of debita spissitudo, behind the certain hour, the skeletal growth factor cell will enter artificial bone inside.But, because the skeletal growth factor cell will enter artificial bone inside, need the long period, and should not infiltrate inside, limited its scope of application.
Three, summary of the invention
The objective of the invention is to overcome the shortcoming of above-mentioned prior art, proposed the composite manufacturing method of the active skeleton of a kind of artificial bio-membrane based on rapid shaping.
The technical solution used in the present invention is in order to achieve the above object:
(1) artificial bone's bionical CAD design:
A, skeleton profile CAD design by section survey of CT feature or outer surface measuring, is used the three-dimensional CAD of characteristic number's strong point reconstruct skeleton profile, and it is expressed with the STL data format;
If the three-dimensional CAD design of b, bones medullary cavity based on the CT profile data, can as if the measurement data based on outer surface, can utilize external surface shape to set up the CAD that mathematical model is constructed medullary cavity with the method construct medullary cavity CAD of reconstruct;
The CAD design of c, skeleton sclerotin tissue by the size and the regularity of distribution of electron microscope observation skeleton micropore, is set up sclerotin and is organized the micro structure mathematical model, and the three-dimensional CAD of structure skeleton guarantees the complete conducting in micropore space;
D, by the bionical CAD Modeling and Design of above three parts, profile CAD and inner CAD are combined, construct complete skeleton CAD;
(2) formation system:
A, make the anti-shape (minus) of section bar material with the method manufacture of intraocular bone of fusion sediment with emulsifying sugar;
B, the three-dimensional CAD data are carried out layering handle, go out the minus (anti-shape) of skeleton profile and internal microstructure with the method rapid shaping of layering manufacturing;
C, pressurizing vessel that has controlled heating system of making, the material that container bottom is opened a 0.2mm extrudes the hole, and the hole is opened and closed by electric-controlled switch control;
D, whole system is installed on the X-Y workbench, has one can form a layering formation system, with the pressurizing vessel realization layering manufacturing of packing into of emulsifying sugar at the shaped platform of Z direction motion;
(3) moulding process:
Emulsifying sugar is packed in the pressurizing vessel, the temperature of pressurizing vessel is controlled at 80-120 ℃, pressure is controlled at flowability and the plasticity that 0.8Pa-1Pa controls emulsifying sugar, emulsifying sugar extrudes the hole by material and extrudes after reaching melting state after the heating, the sugared extruder rate of research emulsifying becomes the relation of filament diameter with X-Y movement velocity and emulsifying sugar, so that control the diameter of different conduits by speed, bone profile and medullary cavity realize by conventional manufacture method successively;
(4) skeletal growth factor and osteoblastic compound:
Skeletal growth factor is made suspension, add osteoblast, make bioactivator, under aseptic condition, the bioactivator temperature is controlled at 36 ℃～38 ℃ exactly, to guarantee osteoblastic activity, bioactivator is poured in the bone die cavity of forming and cultivated, so that skeletal growth factor and osteoblast can be adsorbed onto on the catheterostat, then, again bioactivator is poured out, skeletal growth factor can be retained on the catheterostat, become the active substance of implantable artificial bone;
(5) compound skeletonization manufacturing process:
For improving the intensity of bone, in skeleton, insert the titanium fiber earlier, be compounded in the middle of the bone as reinforcement, to improve the bulk strength of replacement bone, pour into after evenly in the emulsifying sugar bone minus chamber after biology is compound with the spontaneous coagulation calcium hydroxy phosphate, progressively tamp, after waiting to solidify, fall outside emulsifying sugar moulding material with 36 ℃～38 ℃ dissolved in distilled water, the calcium hydroxy phosphate artificial bone is presented.
Another characteristics of the present invention are: the anti-shape (minus) of the method manufacture of intraocular bone of fusion sediment is with bone profile entity sealing, and the inner entity rack that is made of bone marrow body and micropore and siphunculus thereof forms netted cavity structure.
The present invention is directed to the interior gauge structure of skeleton, the skeleton layer data that utilizes the Medical CT machine to obtain.The processing and the processing of the bionical CAD modeling technique of process artificial bone, pore model in setting up, through layering, add date processing such as support, on rapidform machine, adopt special Biodegradable material to produce skeleton profile mould, inner chamber (medullary cavity) mould and artificial bone endoporus three-dimension-framework, simultaneously, in forming process, bioactive substances such as implantable bone somatomedin.Go out to insert the plastic biodegradable matrix material of room temperature in the space, produce the active skeleton of artificial bio-membrane.This method has reached material, molding, bioactive unification.
Four, the specific embodiment
Embodiment 1,
1, artificial bone's bionical CAD design: skeleton profile CAD design, by section survey of CT feature or outer surface measuring, use the three-dimensional CAD of characteristic number's strong point reconstruct skeleton profile, and it is expressed with the STL data format; If the three-dimensional CAD design of bones medullary cavity based on the CT profile data, can as if the measurement data based on outer surface, can utilize external surface shape to set up the CAD that mathematical model is constructed medullary cavity with the method construct medullary cavity CAD of reconstruct; The CAD design of skeleton sclerotin tissue by the size and the regularity of distribution of electron microscope observation skeleton micropore, is set up sclerotin and is organized the micro structure mathematical model, and the three-dimensional CAD of structure skeleton guarantees the complete conducting in micropore space; Bionical CAD Modeling and Design by above three parts combines profile CAD and inner CAD, constructs complete skeleton CAD;
2, formation system: make the anti-shape (minus) of section bar material with the method manufacture of intraocular bone of fusion sediment with emulsifying sugar, the method of fusion sediment is that bone profile entity is sealed, the inner entity rack that is made of bone marrow body and micropore and siphunculus thereof forms netted cavity structure; The three-dimensional CAD data are carried out layering handle, go out the minus (anti-shape) of skeleton profile and internal microstructure with the method rapid shaping of layering manufacturing; Make a pressurizing vessel that has controlled heating system, the material that container bottom is opened a 0.2mm extrudes the hole, and the hole is opened and closed by electric-controlled switch control; Whole system is installed on the X-Y workbench, has one can form a layering formation system, with the pressurizing vessel realization layering manufacturing of packing into of emulsifying sugar at the shaped platform of Z direction motion;
3, moulding process: emulsifying sugar is packed in the pressurizing vessel, the temperature of pressurizing vessel is controlled at 80 ℃, pressure is controlled at flowability and the plasticity that 0.8Pa controls emulsifying sugar, emulsifying sugar extrudes the hole by material and extrudes after reaching melting state after the heating, the sugared extruder rate of research emulsifying becomes the relation of filament diameter with X-Y movement velocity and emulsifying sugar, so that control the diameter of different conduits by speed, bone profile and medullary cavity realize by conventional manufacture method successively;
4, skeletal growth factor and osteoblastic compound: skeletal growth factor is made suspension, add osteoblast, make bioactivator, under aseptic condition, the bioactivator temperature is controlled at 36 ℃ exactly, to guarantee osteoblastic activity, bioactivator is poured in the bone die cavity of forming and cultivated, so that skeletal growth factor and osteoblast can be adsorbed onto on the catheterostat, then, again bioactivator is poured out, skeletal growth factor can be retained on the catheterostat, become the active substance of implantable artificial bone;
5, compound skeletonization manufacturing process: for improving the intensity of bone, in skeleton, insert the titanium fiber earlier, be compounded in the middle of the bone as reinforcement, to improve the bulk strength of replacement bone, pour into after evenly in the emulsifying sugar bone minus chamber after biology is compound with the spontaneous coagulation calcium hydroxy phosphate, progressively tamp, after waiting to solidify, fall outside emulsifying sugar moulding material with 38 ℃ dissolved in distilled water, the calcium hydroxy phosphate artificial bone is presented.
Embodiment 2,
1, artificial bone's bionical CAD design: skeleton profile CAD design, by section survey of CT feature or outer surface measuring, use the three-dimensional CAD of characteristic number's strong point reconstruct skeleton profile, and it is expressed with the STL data format; If the three-dimensional CAD design of bones medullary cavity based on the CT profile data, can as if the measurement data based on outer surface, can utilize external surface shape to set up the CAD that mathematical model is constructed medullary cavity with the method construct medullary cavity CAD of reconstruct; The CAD design of skeleton sclerotin tissue by the size and the regularity of distribution of electron microscope observation skeleton micropore, is set up sclerotin and is organized the micro structure mathematical model, and the three-dimensional CAD of structure skeleton guarantees the complete conducting in micropore space; Bionical CAD Modeling and Design by above three parts combines profile CAD and inner CAD, constructs complete skeleton CAD;
2, formation system: make the anti-shape (minus) of section bar material with the method manufacture of intraocular bone of fusion sediment with emulsifying sugar, the method of fusion sediment is that bone profile entity is sealed, the inner entity rack that is made of bone marrow body and micropore and siphunculus thereof forms netted cavity structure; The three-dimensional CAD data are carried out layering handle, go out the minus (anti-shape) of skeleton profile and internal microstructure with the method rapid shaping of layering manufacturing; Make a pressurizing vessel that has controlled heating system, the material that container bottom is opened a 0.2mm extrudes the hole, and the hole is opened and closed by electric-controlled switch control; Whole system is installed on the X-Y workbench, has one can form a layering formation system, with the pressurizing vessel realization layering manufacturing of packing into of emulsifying sugar at the shaped platform of Z direction motion;
3, moulding process: emulsifying sugar is packed in the pressurizing vessel, the temperature of pressurizing vessel is controlled at 120 ℃, pressure is controlled at flowability and the plasticity that 1Pa controls emulsifying sugar, emulsifying sugar extrudes the hole by material and extrudes after reaching melting state after the heating, the sugared extruder rate of research emulsifying becomes the relation of filament diameter with X-Y movement velocity and emulsifying sugar, so that control the diameter of different conduits by speed, bone profile and medullary cavity realize by conventional manufacture method successively;
4, skeletal growth factor and osteoblastic compound: skeletal growth factor is made suspension, add osteoblast, make bioactivator, under aseptic condition, the bioactivator temperature is controlled at 38 ℃ exactly, to guarantee osteoblastic activity, bioactivator is poured in the bone die cavity of forming and cultivated, so that skeletal growth factor and osteoblast can be adsorbed onto on the catheterostat, then, again bioactivator is poured out, skeletal growth factor can be retained on the catheterostat, become the active substance of implantable artificial bone;
5, compound skeletonization manufacturing process: for improving the intensity of bone, in skeleton, insert the titanium fiber earlier, be compounded in the middle of the bone as reinforcement, to improve the bulk strength of replacement bone, pour into after evenly in the emulsifying sugar bone minus chamber after biology is compound with the spontaneous coagulation calcium hydroxy phosphate, progressively tamp, after waiting to solidify, fall outside emulsifying sugar moulding material with 38 ℃ dissolved in distilled water, the calcium hydroxy phosphate artificial bone is presented.
Embodiment 3
1, artificial bone's bionical CAD design: skeleton profile CAD design, by section survey of CT feature or outer surface measuring, use the three-dimensional CAD of characteristic number's strong point reconstruct skeleton profile, and it is expressed with the STL data format; If the three-dimensional CAD design of bones medullary cavity based on the CT profile data, can as if the measurement data based on outer surface, can utilize external surface shape to set up the CAD that mathematical model is constructed medullary cavity with the method construct medullary cavity CAD of reconstruct; The CAD design of skeleton sclerotin tissue by the size and the regularity of distribution of electron microscope observation skeleton micropore, is set up sclerotin and is organized the micro structure mathematical model, and the three-dimensional CAD of structure skeleton guarantees the complete conducting in micropore space; Bionical CAD Modeling and Design by above three parts combines profile CAD and inner CAD, constructs complete skeleton CAD;
2, formation system: make the anti-shape (minus) of section bar material with the method manufacture of intraocular bone of fusion sediment with emulsifying sugar, the method of fusion sediment is that bone profile entity is sealed, the inner entity rack that is made of bone marrow body and micropore and siphunculus thereof forms netted cavity structure; The three-dimensional CAD data are carried out layering handle, go out the minus (anti-shape) of skeleton profile and internal microstructure with the method rapid shaping of layering manufacturing; Make a pressurizing vessel that has controlled heating system, the material that container bottom is opened a 0.2mm extrudes the hole, and the hole is opened and closed by electric-controlled switch control; Whole system is installed on the X-Y workbench, has one can form a layering formation system, with the pressurizing vessel realization layering manufacturing of packing into of emulsifying sugar at the shaped platform of Z direction motion;
3, moulding process: emulsifying sugar is packed in the pressurizing vessel, the temperature of pressurizing vessel is controlled at 100 ℃, pressure is controlled at flowability and the plasticity that 0.9Pa controls emulsifying sugar, emulsifying sugar extrudes the hole by material and extrudes after reaching melting state after the heating, the sugared extruder rate of research emulsifying becomes the relation of filament diameter with X-Y movement velocity and emulsifying sugar, so that control the diameter of different conduits by speed, bone profile and medullary cavity realize by conventional manufacture method successively;
4, skeletal growth factor and osteoblastic compound: skeletal growth factor is made suspension, add osteoblast, make bioactivator, under aseptic condition, the bioactivator temperature is controlled at 37 ℃ exactly, to guarantee osteoblastic activity, bioactivator is poured in the bone die cavity of forming and cultivated, so that skeletal growth factor and osteoblast can be adsorbed onto on the catheterostat, then, again bioactivator is poured out, skeletal growth factor can be retained on the catheterostat, become the active substance of implantable artificial bone;
5, compound skeletonization manufacturing process: for improving the intensity of bone, in skeleton, insert the titanium fiber earlier, be compounded in the middle of the bone as reinforcement, to improve the bulk strength of replacement bone, pour into after evenly in the emulsifying sugar bone minus chamber after biology is compound with the spontaneous coagulation calcium hydroxy phosphate, progressively tamp, after waiting to solidify, fall outside emulsifying sugar moulding material with 37 ℃ dissolved in distilled water, the calcium hydroxy phosphate artificial bone is presented.
Adopt preparation technology of the present invention that the manufacturing time of the active skeleton of artificial bio-membrane is shortened significantly, only need several days to making finished product from data acquisition, even several hours, can realize clinical manufacturing; Artificial bone and replaced bone shape basically identical help keeping the coupling with original other organ, realize the individuation manufacturing simultaneously; The material of skeleton has fabulous biocompatibility and biodegradability, can be substituted by the human reg osseous tissue gradually; Artificial bone inside has that controlled porosity, pore diameter are controlled, the 3 D stereo bionic micropore structure of on-state rate 100%, and blood vessel and nerve are grown into easily, promote repair process; But the quantity of the micropore of artificial bone inside, size, distribution and shape artificial affecting and control; Have skeletal growth factor, osteogenesis to regulate bioactive substances such as albumen and osteocyte in artificial bone inside, and bioactive substance can be distributed in the place of any needs, can make that artificial bone is very fast to be communicated with the microcirculation in human body tissue; Can also make material when filling reparation, also have further therapeutic purposes at the inner medicines such as anticancer or antiinflammatory that add of artificial bone.
Claims (2)
1, the composite manufacturing method of the active skeleton of a kind of artificial bio-membrane based on rapid shaping is characterized in that:
(1) artificial bone's bionical CAD design:
A, skeleton profile CAD design by section survey of CT feature or outer surface measuring, is used the three-dimensional CAD of characteristic number's strong point reconstruct skeleton profile, and it is expressed with the STL data format;
If the three-dimensional CAD design of b, bones medullary cavity based on the CT profile data, can as if the measurement data based on outer surface, can utilize external surface shape to set up the CAD that mathematical model is constructed medullary cavity with the method construct medullary cavity CAD of reconstruct;
The CAD design of c, skeleton sclerotin tissue by the size and the regularity of distribution of electron microscope observation skeleton micropore, is set up sclerotin and is organized the micro structure mathematical model, and the three-dimensional CAD of structure skeleton guarantees the complete conducting in micropore space;
D, by the bionical CAD Modeling and Design of above three parts, profile CAD and inner CAD are combined, construct complete skeleton CAD;
(2) formation system:
A, make the anti-shape (minus) of section bar material with the method manufacture of intraocular bone of fusion sediment with emulsifying sugar;
B, the three-dimensional CAD data are carried out layering handle, go out the minus (anti-shape) of skeleton profile and internal microstructure with the method rapid shaping of layering manufacturing;
C, pressurizing vessel that has controlled heating system of making, the material that container bottom is opened a 0.2mm extrudes the hole, and the hole is opened and closed by electric-controlled switch control;
D, whole system is installed on the X-Y workbench, has one can form a layering formation system, with the pressurizing vessel realization layering manufacturing of packing into of emulsifying sugar at the shaped platform of Z direction motion;
(3) moulding process:
Emulsifying sugar is packed in the pressurizing vessel, the temperature of pressurizing vessel is controlled at 80-120 ℃, pressure is controlled at flowability and the plasticity that 0.8Pa-1Pa controls emulsifying sugar, emulsifying sugar extrudes the hole by material and extrudes after reaching melting state after the heating, the sugared extruder rate of research emulsifying becomes the relation of filament diameter with X-Y movement velocity and emulsifying sugar, so that control the diameter of different conduits by speed, bone profile and medullary cavity realize by conventional manufacture method successively;
(4) skeletal growth factor and osteoblastic compound:
Skeletal growth factor is made suspension, add osteoblast, make bioactivator, under aseptic condition, the bioactivator temperature is controlled at 36 ℃～38 ℃ exactly, to guarantee osteoblastic activity, bioactivator is poured in the bone die cavity of forming and cultivated, so that skeletal growth factor and osteoblast can be adsorbed onto on the catheterostat, then, again bioactivator is poured out, skeletal growth factor can be retained on the catheterostat, become the active substance of implantable artificial bone;
(5) compound skeletonization manufacturing process:
For improving the intensity of bone, in skeleton, insert the titanium fiber earlier, be compounded in the middle of the bone as reinforcement, to improve the bulk strength of replacement bone, pour into after evenly in the emulsifying sugar bone minus chamber after biology is compound with the spontaneous coagulation calcium hydroxy phosphate, progressively tamp, after waiting to solidify, fall outside emulsifying sugar moulding material with 36 ℃～38 ℃ dissolved in distilled water, the calcium hydroxy phosphate artificial bone is presented.
2, the composite manufacturing method of the active skeleton of the artificial bio-membrane based on rapid shaping according to claim 1, it is characterized in that: the said anti-shape (minus) of using the method manufacture of intraocular bone of fusion sediment, be that bone profile entity is sealed, the inner entity rack that is made of bone marrow body and micropore and siphunculus thereof forms netted cavity structure.
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