Bionic artificial semi-joint body and manufacturing technique thereof
Technical Field The invention belongs to the field of manufacturing engineering, in particular to a bionic artificial semi-joint body and its manufacturing process. New manufacturing process, in particular according to the anatomical characteristics of the joint, the function of differentiating cartilage with the bone, within the body of the artificial semi-joint with the cartilage design a three-dimensional porous structure of cartilage; and the polyurethane elastomer and biological ceramic material composite forming, a complicated molding surface accurate matching joint defect area of bionic artificial semi-joint body. Background Art Joint diseases and frequently is a common disease, serious condition can cause joint movement dysfunction, or even disabled, through joint replacement operation to replace the patient's semi-joint or the whole joint. There is only one side of the patient joint damage, especially to the is in the development stage of the in adolescent patients, for example, because of the lower limb and the two ends of the long bone growth is primarily dependent on the epiphysis, if the single-side limb full knee replacement, is bound to undermine the side of the tibia at the upper end of the femur epiphysis and the lower end of the, impact on the growth of the limbs and eventually lead to the same length and the function of double-infrapopliteal not limited. If only the damaged half joint of the half-joint replacement will be ideal for the treatment of the programme. In the present joint replacement operation is the main joint body of the user and with the cartilage complex metal artificial joint, the former while the therapeutic effect is better, but there is a limited source, matches the shape difficulties, problems such as infection, the latter because the metal and the abrasion of the various degrees between the bone will gradually loose failure, resulting in 30% of patients in the 10 years need of refurbishment operation, not only costly, also bear surgical pain once again. Nevertheless, full some 3.5 billion joint disease patient (China about 1 billion patient's) need a large number of artificial joint, each year the demand for metal hip joint only in respect of more than 100 million pieces, therefore, to find an ideal, non-metal artificial joint body is the key joint is replaced. Because the joint the existence of cartilage with bone two different organizations, therefore the existing non-metallic bionic artificial joint body manufacturing method mainly adopts cartilage with bone composite double-layer structure, that is, customized has first been obtained through the mould of the appearance structure of cartilage, then the different material by coating, extrusion method with a cartilage with bone interface structure of the complex. After implanting, the composite structure joint body through bone fixing and implanted region, and the side of the through the cartilage of the joint cartilage contact, and to reduce the contact friction side. However, this kind of method to obtain the artificial joint body but has a problem: on the one hand, because no special for the cartilage cells and the blood circulation pore structure, therefore there can be no guarantee that bone with bone tissue very good recovering from injuries , it will be difficult for the position of the long-term fixed joint prosthesis; on the other hand, a simple coating or extrusion forming process, are difficult to control accurately on the joint prosthesis with the bone cartilage interface structure (such as the cartilage thickness and area), even after implantation of the joint prosthesis occurs on the interface separation, and the like. Content of the invention The present invention is directed to the prior art double-layer non-metal of the cartilage with the defect of the bone composite joint body, provides a can effectively promote bone growth, promoting hyperosteogeny of the implanting region recovering from injuries ; enhanced activity of the knuckle joint and reduce the friction and damage of the bionic artificial semi-joint body and its manufacturing process. In order to achieve the above-mentioned purpose, the preparation process of the present invention: first of all according to the conditions of the patients by reverse engineering structure biomimesis artificial semi-joint body of curved shape, and using the three-dimensional design software form a bionic artificial semi-joint of the concave die and shell model, then, according to the half-joint cartilage and cartilage thickness data and interface shape of the bone is divided into an upper, middle and lower three parts; the design according to the function of each layer within the same column negative structure, that is, the structure of the upper layer is the squirrel-cage column, column section is homogeneous rule structure, the middle layer is of a hollow structure, the pipe column structure intersecting vertically each other, finally the each layer of the model and artificial semi-joint shell model combining, to form the artificial semi-joint body structure model negative shape ; rapid forming machine itself the layered software to model negative shape layered, layer thickness: 0.10 mm, according to the result of the layered after forming machine with a precise photo-curing resin mold negative shape prosthesis structure; the ceramic powder, hydrosolvent, organic monomer, dispersant and cross-linking agent to the 110-120 [...] the 60-80 [...] the 6-8 [...] the 1-2 [...] 1-1.5 uniformly mixing of the mass ratio, removal of air bubbles into the vacuum machine, and the mixture of concentrated ammonia water PH=9 obtain slurry, and then in the slurry in the quality of the cross-linking agent is added to 0.2-0.5 times the initiator and catalyst are formed into a ceramic slurry; the ceramic slurry is filled into the prosthesis structure in the resin mold negative shape , and into vacuum high temperature furnace from room temperature to in the 100 [...] /hour the temperature rise speed of the temperature to the 800 [...] -1000 the insulation [...] 1.5-2 hours to be cured, is then taken out of the furnace cooling to room temperature; according to the 8 [...] 1 than the polyurethane and the quality of the polyurethane type corresponding to the solid polyurethane solution; the polyurethane solution is poured into the concave mold, cured and then the formed ceramic body is placed in the polyurethane solution, vacuum pumping, in 0.01-0.0005 MPa is placed under a vacuum of 0.5 hours, the normal pressure, is under room temperature 12-24 hours taken to be polyurethane fully solidified; taking the mould inner half joint body, shaping is obtained for the ceramic portion of the bone material, cartilage elastic material is polyurethane elastomer artificial semi-joint body. Precision of the present invention of photo-curing is the wavelength of the laser machine 355 nm; light spot diameter is 0.2 mm; filling scanning velocity is 5000 mm/s; filling vector distance is 0.10 mm; support scanning velocity is 2000 mm/s; hop cross-speed is 8000 mm/s; profile scanning speed is 3000 mm/s; compensating a diameter of 0.12 mm; the lifting speed of the worktable to 4.00 mm/s; point supporting scanning time is 0.50ms; veined structure scanning time is 0.50ms; the lower layer 3 of the tubular column structure to the tubular column orthogonal structure or other biomimesis tubular column structure; hydrosolvent is deionized water; ceramic powder as Beta-tricalcium phosphate (β-TCP), (α-TCP) Alpha-tricalcium phosphate, hydroxyapatite (HAP), calcium carbonate or alumina; organic monomer is acrylamide, methyl-methoxyethyl trimethyl ammonium chloride or adipic acid dihydrazide; the cross-linking agent is N, N-dimethylene two acrylamide, N, N-Acetonyl acrylamide or dibenzylidene Acetonyl acrylamide, dispersing agent is sodium polyacrylate or ammonium polyacrylate, the initiator is ammonium persulfate, sodium persulfate or potassium persulfate, the catalyst is N, N, N 'N' -tetramethyl ethylenediamine, N, N-dimethyl-cyclohexylamine or N, N, N ', N ", N"-pentamethyl-diethylene-triamine. Semi-joint body of the present invention comprises: a ceramic portion of the bone-contacting surface, and the joint contact and two part polyurethane elastomer, said ceramic portion of the implant in the bone region for the three-dimensional porous structure recovering from injuries ; polyurethane elastomer through the top of the ceramic portion of the squirrel-cage three-dimensional porous structure is fixed to the ceramic part. The cartilage of the present invention in-mold injection molding polyurethane elastomer material cartilage, precise control of the thickness of the cartilage, area and shape, the side that in contact with the cartilage of the joint, reduces the friction and damage of the side, the ability to enhance the activities of the joint. Bone through the light-cured indirect shaping process manufacturing gradient porous structure, not only can at the same time a complete customization of the cartilage internal and external structure, its internal porous structure also has a triple function, in other words ensuring the bio-ceramic material and a polyurethane elastomer material function of combining the closely; the promotion of cell adhesion, the body fluid and with the metabolism of the infiltration of oxygen, or the like, ensure that the new bone growth bone layer and the integration of the function of the artificial prosthesis; accurately control the size of the cartilage with bone interface function. Because this shark cartilage level internal three-dimensional porous structure comprises an upper, middle, lower three parts, the upper layer is the squirrel-cage pore structure, ensuring biological ceramic material and tightly combined with polyurethane elastomer material; non-porous middle layer, the polyurethane elastomer material will not enter the lower passage of the bone-contacting surface, and; the lower layer contact with the bone tunnel with orthogonal or other biomimesis pore structure, ensuring osteocompatibility and nutrition can enter the ceramic material, so that the prosthesis can be well and recovering from injuries. Description of drawings Figure 1 is an exploded view of three-dimensional cartilage negative shape structure model of the invention; Figure 2 is a three-dimensional bone model negative shape structure of the invention; Figure 3 is a model diagram of the invention; Figure 4 is the overall three-dimensional map, wherein Figure 4a is an elevational view, Figure 4b is a side view of the invention. Mode of execution The following binding with photos of the present invention is described further in detail. Embodiment 1, igur 1, 2, 3, 4, the preparation process of this invention are as follows: first of all according to the conditions of the patients by reverse engineering structure biomimesis artificial semi-joint body of curved shape, and using the three-dimensional design software form a bionic artificial semi-joint of the concave die and shell model, then, according to the half-joint cartilage and cartilage thickness data and interface shape of the bone is divided into an upper 1, middle level 2 and a lower 3 three parts; the design according to the function of each layer within the same column negative structure, that is, the upper layer 1 is a squirrel-cage tubular column structure, column section is homogeneous rule structure, the middle layer 2 is of a hollow structure, the lower layer 3 having mutually perpendicular intersecting orthogonal of bionic pipe column structure or other structure, finally the each layer of the model and artificial semi-joint shell model combining, to form the artificial semi-joint body structure model negative shape ; rapid forming machine itself the layered software pair of concave mold and negative shape model is hierarchically, layer thickness: 0.10 mm, according to the result of the layered after forming machine with a precise photo-curing resin mold negative shape prosthesis structure; precision light solidifying and forming machine for laser wavelength of 355 nm; light spot diameter is 0.2 mm; filling scanning velocity is 5000 mm/s; filling vector distance is 0.10 mm; support scanning velocity is 2000 mm/s; hop cross-speed is 8000 mm/s; profile scanning speed is 3000 mm/s; compensating a diameter of 0.12 mm; the lifting speed of the worktable to 4.00 mm/s; point supporting scanning time is 0.50ms; veined structure scanning time is 0.50ms; the-tricalcium phosphate (β-TCP) Beta, deionized water, acrylamide, sodium polyacrylate and N, N-dimethylene two acrylamide according to the 110 [...] the 70 [...] the 8 [...] the 2 [...] 1 uniformly mixing of the mass ratio, removal of air bubbles into the vacuum machine, and the mixture of concentrated ammonia water PH=9 obtain slurry, and then in the slurry in the quality of the cross-linking agent is added to 0.4 times of ammonium persulfate and N, N, N 'N' -tetramethyl ethylenediamine forming β-TCP ceramic slurry; will be filled with ceramic slurry β-TCP negative shape resin mold to a prosthesis in the structure of, and into vacuum high temperature furnace from room temperature to in the 100 [...] /hour the temperature rise speed of the temperature is increased to 1000 the insulation [...] 1.5 hours to be cured, is then taken out of the furnace cooling to room temperature; according to the 8 [...] 1 than the polyurethane and the quality of the polyurethane type corresponding to the solid polyurethane solution; the polyurethane solution is poured into the concave mold, and then the ceramic body β-TCP curing molding in the polyurethane solution, vacuum pumping, in 0.01-0.0005 MPa is placed under a vacuum of 0.5 hours, the normal pressure, is under room temperature 12-24 hours taken to be polyurethane fully solidified; taking the mould inner half joint body, shaping is obtained for the ceramic portion of the bone material 4, cartilage elastic material is polyurethane elastomer 5 artificial semi-joint body, the ceramic portion of the half-joint body 4 with the promotion of the implanting region in hyperosteogeny of the three-dimensional porous structure recovering from injuries ; polyurethane elastomer 5 through the ceramic part 4 squirrel-cage on the top of the three-dimensional porous structure is fixed to the ceramic part. Embodiment 2, this embodiment is the hydroxy apatite (HAP), deionized water, acrylamide, sodium polyacrylate and N, N-dimethylene two acrylamide, ammonium polyacrylate and N, N-Acetonyl acrylamide according to the 115 [...] the 80 [...] the 6 [...] the 1 [...] 1.3 mixing of the mass ratio, removal of air bubbles into the vacuum machine, and the mixture of concentrated ammonia water PH=9 obtain slurry, and then in the slurry in the quality of the cross-linking agent is added to 0.2 times that of the sodium persulfate and N, formed-dimethyl cyclohexylamine N HAP ceramic slurry; the HAP ceramic slurry is filled into the prosthesis structure in the resin mold negative shape , and into vacuum high temperature furnace from room temperature to in the 100 [...] /hour the temperature rise speed of the temperature to 900 the insulation [...] 1.8 hours to be cured, and then cooled to the room temperature taken out of the furnace; other step with embodiment 1, so as to obtain material as the ceramic portion of the cartilage 4, cartilage elastic material is polyurethane elastomer 5 artificial semi-joint body, the ceramic portion of the half-joint body 4 with the promotion of the implanting region in hyperosteogeny of the three-dimensional porous structure recovering from injuries ; polyurethane elastomer 5 through the ceramic part 4 squirrel-cage on the top of the three-dimensional porous structure is fixed to the ceramic part. Embodiment 3, the embodiment is the alumina, deionized water, methyl-methoxyethyl trimethyl ammonium chloride, sodium polyacrylate and dibenzylidene Acetonyl acrylamide according to the 120 [...] the 60 [...] the 7 [...] the 1.6 [...] 1.5 uniformly mixing of the mass ratio, removal of air bubbles into the vacuum machine, and the mixture of concentrated ammonia water PH=9 obtain slurry, and then in the slurry in the quality of the cross-linking agent is added to 0.2 times of potassium persulphate and 0.5 times N, N, N ', N ", N"-pentamethyl-diethylene-triamine formation of the aluminum oxide ceramic slurry; the alumina ceramic slurry is filled into the prosthesis structure in the resin mold negative shape , and into vacuum high temperature furnace from room temperature to in the 100 [...] /hour the temperature rise speed of the temperature to 800 the insulation [...] 2 hours to be cured, and then cooled to the room temperature taken out of the furnace; other step with embodiment 1, so as to obtain material as the ceramic portion of the cartilage 4, cartilage elastic material is polyurethane elastomer 5 artificial semi-joint body, the ceramic portion of the half-joint body 4 with the promotion of the implanting region in hyperosteogeny of the three-dimensional porous structure recovering from injuries ; polyurethane elastomer 5 through the ceramic part 4 squirrel-cage on the top of the three-dimensional porous structure is fixed to the ceramic part. A simulation manual semi-joint body and fabrication technics are provided, which forms a shell model through reverse engineering and 3D design software and the divides the bone layer into three parts, namely upper, middle and lower layer; then designing the internal pipe column negative structure according to the funvtions of each layer and finally combining the model of each layer and the shell model to form the negetive model. The invention shapes the false body model by adopting the speedy shaping and exact photocureable forming machine, fills the ceramics slurry into the false body model and solidifies it in vacuum high temperature stove and then places the solidified ceramics body in polyurethane solution module; then pumping the vacuum, placing the module still and then taking out the ceramics after the polyurethane fully solidified; shaping it, thus achieving the bone layer material serving as the ceramics part; the soft bone layer elastomer is made of manual semi-joint body of the polyurethane elastomer. The invention reduces the rubbing damage for side joints and strengthens the activity capacity of the joints when the soft bone layer contacting the side joints. 1, bionic artificial semi-joint body manufacturing process, characterized in that 1) first of all according to the conditions of the patients by reverse engineering structure biomimesis artificial semi-joint body of curved shape, and using the three-dimensional design software form a bionic artificial semi-joint of the concave die and shell model, then, according to the half-joint cartilage and cartilage thickness data and interface shape of the bone is divided into an upper (1), the middle layer (2) and the lower layer (3) of three parts; the design according to the function of each layer within the same column negative structure, that is, the upper (1) structure of the squirrel-cage column, column section is homogeneous rule structure, the middle layer (2) is of a hollow structure, the lower layer (3) has a vertical pipe column structure of intersecting, finally the each layer of the model and artificial semi-joint shell model combining, to form the artificial semi-joint body structure negative shape model; 2) rapid forming machine itself the layered software to model negative shape layered, layer thickness: 0.10 mm, according to the result of the layered after forming machine with a precise photo-curing resin mold negative shape prosthesis structure; 3) the ceramic powder, hydrosolvent, organic monomer, dispersant and cross-linking agent to the 110-120 [...] the 60-80 [...] the 6-8 [...] the 1-2 [...] 1-1.5 uniformly mixing of the mass ratio, removal of air bubbles into the vacuum machine, and the mixture of concentrated ammonia water PH=9 obtain slurry, and then in the slurry in the quality of the cross-linking agent is added to 0.2-0.5 times the initiator and catalyst are formed into a ceramic slurry; 4) the ceramic slurry is filled into the prosthesis structure in the resin mold negative shape , and into vacuum high temperature furnace from room temperature to in the 100 [...] /hour the temperature rise speed of the temperature to the 800 [...] -1000 the insulation [...] 1.5-2 hours to be cured, is then taken out of the furnace cooling to room temperature; 5) according to the 8 [...] 1 than the polyurethane and the quality of the polyurethane type corresponding to the solid polyurethane solution; 6) the polyurethane solution is poured into the concave mold, cured and then the formed ceramic body is placed in the polyurethane solution, vacuum pumping, in 0.01-0.0005 MPa is placed under a vacuum of 0.5 hours, the normal pressure, is under room temperature 12-24 hours taken to be polyurethane fully cured; 7) taking the mould inner half joint body, shaping is obtained for the ceramic portion of the bone material (4), cartilage elastic material is polyurethane elastomer (5) artificial semi-joint body. 2, bionic artificial semi-joint body manufacturing process according to Claim 1, characterized in that said precision optical solidifying and forming machine for laser wavelength of 355 nm; light spot diameter is 0.2 mm; filling scanning velocity is 5000 mm/s; filling vector distance is 0.10 mm; support scanning velocity is 2000 mm/s; hop cross-speed is 8000 mm/s; profile scanning speed is 3000 mm/s; compensating a diameter of 0.12 mm; the lifting speed of the worktable to 4.00 mm/s; point supporting scanning time is 0.50ms; veined structure scanning time is 0.50ms. 3, bionic artificial semi-joint body manufacturing process according to Claim 1, characterized in that said lower layer (3) of the tubular column structure to the tubular column orthogonal structure or other biomimesis tubular column structure. 4, bionic artificial semi-joint body manufacturing process according to Claim 1, characterized in that said solvent is deionized water; ceramic powder as Beta-tricalcium phosphate (β-TCP), (α-TCP) Alpha-tricalcium phosphate, hydroxyapatite (HAP), calcium carbonate or alumina; organic monomer is acrylamide, methyl-methoxyethyl trimethyl ammonium chloride or adipic acid dihydrazide; the cross-linking agent is N, N-dimethylene two acrylamide, N, N-Acetonyl acrylamide or dibenzylidene Acetonyl acrylamide, dispersing agent is sodium polyacrylate or ammonium polyacrylate, the initiator is ammonium persulfate, sodium persulfate or potassium persulfate, the catalyst is N, N, N 'N' -tetramethyl ethylenediamine, N, N-dimethyl-cyclohexylamine or N, N, N ', N ", N"-pentamethyl-diethylene-triamine. 5, a method according to claim 1 for the manufacture of the bionic artificial semi-joint body, characterized in that comprises a ceramic portion of the bone-contacting surface, and (4) and the joint contact polyurethane elastomer (5) of two parts, said ceramic part (4) of the implanting region in hyperosteogeny with the promotion of the three-dimensional porous structure recovering from injuries ; polyurethane elastomer (5) through the ceramic part (4) at the top of the squirrel-cage three-dimensional porous structure is fixed on the ceramic part.