CN100528103C - Bionic artificial semi-joint body and manufacturing technique thereof - Google Patents

Bionic artificial semi-joint body and manufacturing technique thereof Download PDF

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Publication number
CN100528103C
CN100528103C CN 200710018461 CN200710018461A CN100528103C CN 100528103 C CN100528103 C CN 100528103C CN 200710018461 CN200710018461 CN 200710018461 CN 200710018461 A CN200710018461 A CN 200710018461A CN 100528103 C CN100528103 C CN 100528103C
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model
polyurethane
semi
ceramic
articulation body
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CN101108145A (en
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连芩
李涤尘
李翔
靳忠民
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Xian Jiaotong University
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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
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • 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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Manufacturing & Machinery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

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.

Description

Biomimetic prosthetic semi-articulation body and manufacturing process thereof
Technical field
The invention belongs to the manufacturing engineering field, particularly a kind of biomimetic prosthetic semi-articulation body and manufacturing process.
Make new technology, particularly it distinguishes cartilage and bone function according to the anatomical features in joint, goes out the three-dimensional porous structure of cartilage layers and osteoplaque in artificial semi-articulation body indoor design; And, produce the biomimetic prosthetic semi-articulation body that can accurately mate joint defective region complex profile with polyurethane elastomer and bioceramic material combined shaping.
Background technology
Joint disease is a kind of commonly encountered diseases and frequently-occurring disease, can cause the joint motions dysfunction when being in a bad way, even disabled, needs to replace by joint replacement patient's semiarthrosis or total joint.For the patient that a side joint injury is only arranged, especially for the adolescent patient that is in the stage of development, for example, because the growth and the growing tall of whole body of lower limb mainly depend on the epiphysis at long bone two ends, if carry out total knee replacement at one-sided limbs, certainly will destroy the epiphysis of this side distal part of femur and tibia upper end, influence the growth of limbs and finally cause pair leg length discrepancys and function limitation.If only impaired semiarthrosis being carried out the semiarthrosis displacement will be comparatively ideal therapeutic scheme.
The joint body that adopts in the joint replacement mainly is complex and the metal artificial joint from body bone and cartilage at present, though the former therapeutic effect is better, but exist limited for the source, join problems such as shape difficulty, infection, the latter was because of in various degree loosening gradually inefficacy of wearing and tearing meeting between metal and the diaphysis, cause nearly 30% patient to carry out revision procedure 10 years domestic demands, not only cost dearly, also will bear the misery of operation once more.However, the about 3.5 hundred million joint disease patients in the whole world (China about 100,000,000 patients) need a large amount of artificial jointes, and the demand of annual only metal hip joint just surpasses 1,000,000, the key that therefore to seek ideal nonmetal artificial joint body be joint replacement.
Because the joint exists two kinds of different tissues of cartilage and bone, therefore the manufacture method of the nonmetal biomimetic prosthetic joint body that exists at present mainly is to adopt cartilage layers and the compound double-decker of osteoplaque, promptly at first obtain the osteoplaque contour structures that customizes by mould, methods such as then that different materials is coated, extruding are combined with each other and form the complex with cartilage and bone interface structure.After the implantation, this composite construction joint body is fixed and the implantation region by osteoplaque, contacts with cartilage on the offside joint by cartilage layers, reduces the contact friction with the offside joint.But the artificial joint body that this method obtains but exists problem: on the one hand, owing to there is not the pore structure that is exclusively used in cell proliferation and blood circulation in the osteoplaque, so can not guarantee the good ankylose of osteoplaque and osseous tissue, also just be difficult to the position of extended immobilization articular prosthesis; On the other hand, simply coating or extrusion forming process are difficult to accurately control cartilage and bone interface structure (for example cartilage layers thickness and area) on the articular prosthesis, even the problems such as interfacial separation of articular prosthesis can take place after implantation.
Summary of the invention
The present invention is directed to the defective of the nonmetallic double-deck cartilage and the bone composite joint body of present existence, a kind of promote osteogenesis effectively is provided, promote and implantation region sclerotin ankylose; Strengthen the mobility in joint and reduce biomimetic prosthetic semi-articulation body and manufacturing process thereof the frictionally damage in joint.
For achieving the above object, preparation technology of the present invention is: the appearance curved surface of at first constructing the biomimetic prosthetic semi-articulation body according to patient's situation by reverse engineering, and utilize Three-dimensional Design Software to form the female mold and the Shell model of biomimetic prosthetic semiarthrosis, according to the cartilage of this semiarthrosis and the interface shape and the thickness data of osteoplaque osteoplaque is divided into three parts in the upper, middle and lower then; Design its inner tubing string minus structure respectively according to each layer function, be that the upper strata is a mouse cage shape tubular column structure, the tubing string cross section is even regular texture, the middle level is a cavity structure, lower floor has the tubular column structure that intersects vertically mutually, at last the Shell model of each layer model with artificial semiarthrosis merged, form the negative shape model of artificial semi-articulation body structure; Adopt the delamination software of rapidform machine self that negative shape model is carried out layering, lift height: 0.10mm, utilize precise light curing formation machine molding borrowed structure to bear the shape resin die according to the result after the layering; Ceramic powders, aqueous solvent, organic monomer, dispersant and cross-linking agent are compared mix homogeneously by the quality of 110-120: 60-80: 6-8: 1-2: 1-1.5, put into the vacuum machine and remove bubble, and make the PH=9 of mixture obtain slurry with the strong aqua ammonia adjustment, in slurry, add cross-linking agent quality 0.2-0.5 initiator and catalyst doubly more respectively and form ceramic slurry; Ceramic slurry is filled in the negative shape resin die of borrowed structure, and inserts in the high-temperature vacuum furnace and to be warming up to 800 ℃～1000 ℃ insulations from room temperature with 100 ℃/hour programming rate and to be cured in 1.5～2 hours, cool to room temperature then with the furnace and take out; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; Polyurethane solutions is poured in the female mold, then the ceramic body with curing molding places polyurethane solutions, evacuation was placed 0.5 hour under the vacuum of 0.01～0.0005Mpa, placed under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 12～24 hours; Take out the semi-articulation body in the mould, it is ceramic segment that shaping promptly obtains the osteoplaque material, and the cartilage layers elastomeric material is the artificial semi-articulation body of polyurethane elastomer.
The wavelength of the laser instrument of precise light curing formation machine of the present invention is 355nm; Spot diameter is 0.2mm; The filling scanning speed is 5000mm/s; Filling vectorial spacing is 0.10mm; The support scanning speed is 2000mm/s; The jumping speed of striding is 8000mm/s; Profile scan speed is 3000mm/s; The compensation diameter is 0.12mm; Worktable lifting speed is 4.00mm/s; It is 0.50ms that point supports sweep time; Stricture of vagina structure sweep time is 0.50ms; The tubular column structure of lower floor 3 is tubing string orthohormbic structure or other bionical tubular column structures; Aqueous solvent is a deionized water; Ceramic powders is Beta-tricalcium phosphate (β-TCP), Alpha-tricalcium phosphate (α-TCP), hydroxyapatite (HAP), calcium carbonate or an aluminium oxide; Organic monomer is acrylamide, methyl-acyl-oxygen ethyl-trimethyl salmiac or adipic dihydrazide; Cross-linking agent is N, N-dimethylene diacrylamine, N, N-two acetonyl acrylamides or dibenzalacetone base acrylamide, dispersant is sodium polyacrylate or ammonium polyacrylate, initiator is Ammonium persulfate., sodium peroxydisulfate or potassium peroxydisulfate, and catalyst is N, N, N ' N '-tetramethylethylenediamine, N, N-dimethyl cyclohexyl amine or N, N, N ', N ", N " pentamethyl-diethylenetriamine.
Semi-articulation body of the present invention comprises: the ceramic segment that contacts with bone and form with polyurethane elastomer two parts of joint contact has the three-dimensional porous tubular column structure that promotes with implantation region sclerotin ankylose in the said ceramic segment; Polyurethane elastomer is fixed on the ceramic segment by the mouse cage shape three-dimensional porous structure at ceramic segment top.
Cartilage layers of the present invention adopts in-mould injection molded polyurethanes elastomeric material cartilage layers, accurately control thickness, area and the contour structures of cartilage layers, when guaranteeing cartilage layers and offside joint contact, reduce frictionally damage, strengthen the mobility in joint the offside joint.Make gradient porous structure by photocuring indirect forming technology on the osteoplaque, can not only finish the external and internal compositions of the one customization of osteoplaque simultaneously, its inner loose structure also has triple functions, promptly guarantees the function that bioceramic material and polyurethane elastomer material are combined closely; Promote the infiltration and the metabolism of cell attaching, body fluid and oxygen etc., guarantee in the osteoplaque new bone growth and with the function of the fusion of artificial prosthesis; Accurately control the function of cartilage layers and osteoplaque interface dimensions.Because this shark bone layer interior three-dimensional loose structure comprises upper strata, centre, lower floor's three parts, the upper strata is a mouse cage shape pore passage structure, guarantees that bioceramic material and polyurethane elastomer material are in conjunction with tight; The imporosity, middle level guarantees that polyurethane elastomer material can not enter the duct that lower floor contacts with bone; The duct that lower floor contacts with bone has quadrature or other bionical pore passage structures, guarantees that osteocyte and nutrition can enter ceramic material inside, makes prosthese and bone ankylose well.
Description of drawings
Fig. 1 is the three-dimensional negative shape structural model exploded view of osteoplaque of the present invention;
Fig. 2 is the three-dimensional negative shape structural model figure of osteoplaque of the present invention;
Fig. 3 is a spill illustraton of model of the present invention;
Fig. 4 is a whole graphics of the present invention, and wherein Fig. 4 a is a front view, and Fig. 4 b is a side view.
The specific embodiment
The present invention is described in further detail below in conjunction with accompanying drawing.
Embodiment 1, referring to Fig. 1,2,3,4, preparation process of the present invention is as follows: at first construct the appearance curved surface of biomimetic prosthetic semi-articulation body according to patient's situation by reverse engineering, and utilize Three-dimensional Design Software to form the female mold and the Shell model of biomimetic prosthetic semiarthrosis, according to the cartilage of this semiarthrosis and the interface shape and the thickness data of osteoplaque osteoplaque is divided into upper strata 1,3 three parts in middle level 2 and lower floor then; Design its inner tubing string minus structure respectively according to each layer function, be that upper strata 1 is mouse cage shape tubular column structure, the tubing string cross section is even regular texture, middle level 2 is a cavity structure, lower floor 3 has tubing string orthohormbic structure or other the bionical tubular column structures that intersects vertically mutually, at last the Shell model of each layer model with artificial semiarthrosis merged, form the negative shape model of artificial semi-articulation body structure; Adopt the delamination software of rapidform machine self that female mold and negative shape model are carried out layering, lift height: 0.10mm, utilize precise light curing formation machine molding borrowed structure to bear the shape resin die according to the result after the layering; The wavelength of the laser instrument of precise light curing formation machine is 355nm; Spot diameter is 0.2mm; The filling scanning speed is 5000mm/s; Filling vectorial spacing is 0.10mm; The support scanning speed is 2000mm/s; The jumping speed of striding is 8000mm/s; Profile scan speed is 3000mm/s; The compensation diameter is 0.12mm; Worktable lifting speed is 4.00mm/s; It is 0.50ms that point supports sweep time; Stricture of vagina structure sweep time is 0.50ms; With Beta-tricalcium phosphate (β-TCP), deionized water, acrylamide, sodium polyacrylate and N, N-dimethylene diacrylamine was by 110: 70: 8: 2: 1 quality is put into the vacuum machine and is removed bubble than mix homogeneously, and make the PH=9 of mixture obtain slurry with the strong aqua ammonia adjustment, the Ammonium persulfate. and the N that add 0.4 times of cross-linking agent quality again in slurry respectively, N, N ' N '-tetramethylethylenediamine form β-TCP pottery slurry; β-TCP pottery slurry is filled in the negative shape resin die of borrowed structure, and inserts in the high-temperature vacuum furnace and to be warming up to 1000 ℃ of insulations from room temperature with 100 ℃/hour programming rate and to be cured in 1.5 hours, cool to room temperature then with the furnace and take out; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; Polyurethane solutions is poured in the female mold, then β-TCP the ceramic body with curing molding places polyurethane solutions, evacuation was placed 0.5 hour under the vacuum of 0.01～0.0005Mpa, placed under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 12～24 hours; Take out the semi-articulation body in the mould, it is ceramic segment 4 that shaping promptly obtains the osteoplaque material, the cartilage layers elastomeric material is the artificial semi-articulation body of polyurethane elastomer 5, has the three-dimensional porous tubular column structure that promotes with implantation region sclerotin ankylose in the ceramic segment 4 of this artificial semi-articulation body; Polyurethane elastomer 5 is fixed on the ceramic segment by the mouse cage shape three-dimensional porous structure at ceramic segment 4 tops.
Embodiment 2, this enforcement is with hydroxyapatite (HAP), deionized water, acrylamide, sodium polyacrylate and N, N-dimethylene diacrylamine, ammonium polyacrylate and N, N-two acetonyl acrylamides were by 115: 80: 6: 1: 1.3 quality compares mix homogeneously, put into the vacuum machine and remove bubble, and make the PH=9 of mixture obtain slurry with the strong aqua ammonia adjustment, and in slurry, adding the sodium peroxydisulfate and the N of 0.2 times of cross-linking agent quality more respectively, the N-dimethyl cyclohexyl amine forms HAP pottery slurry; HAP pottery slurry is filled in the negative shape resin die of borrowed structure, and inserts in the high-temperature vacuum furnace and to be warming up to 900 ℃ of insulations from room temperature with 100 ℃/hour programming rate and to be cured in 1.8 hours, cool to room temperature then with the furnace and take out; Other step is with embodiment 1, thereby obtain the osteoplaque material is ceramic segment 4, the cartilage layers elastomeric material is the artificial semi-articulation body of polyurethane elastomer 5, has the three-dimensional porous tubular column structure that promotes with implantation region sclerotin ankylose in the ceramic segment 4 of this artificial semi-articulation body; Polyurethane elastomer 5 is fixed on the ceramic segment by the mouse cage shape three-dimensional porous structure at ceramic segment 4 tops.
Embodiment 3, present embodiment is with aluminium oxide, deionized water, methyl-acyl-oxygen ethyl-trimethyl salmiac, sodium polyacrylate and dibenzalacetone base acrylamide were by 120: 60: 7: 1.6: 1.5 quality compares mix homogeneously, put into the vacuum machine and remove bubble, and make the PH=9 of mixture obtain slurry, in slurry, add potassium peroxydisulfate and 0.5 times of N of 0.2 times of cross-linking agent quality more respectively with the strong aqua ammonia adjustment, N, N ', N ", " pentamethyl-diethylenetriamine forms the aluminium oxide ceramics slurry to N; The aluminium oxide ceramics slurry is filled in the negative shape resin die of borrowed structure, and inserts in the high-temperature vacuum furnace and to be warming up to 800 ℃ of insulations from room temperature with 100 ℃/hour programming rate and to be cured in 2 hours, cool to room temperature then with the furnace and take out; Other step is with embodiment 1, thereby obtain the osteoplaque material is ceramic segment 4, the cartilage layers elastomeric material is the artificial semi-articulation body of polyurethane elastomer 5, has the three-dimensional porous tubular column structure that promotes with implantation region sclerotin ankylose in the ceramic segment 4 of this artificial semi-articulation body; Polyurethane elastomer 5 is fixed on the ceramic segment by the mouse cage shape three-dimensional porous structure at ceramic segment 4 tops.

Claims (5)

1, the manufacturing process of biomimetic prosthetic semi-articulation body is characterized in that:
1) at first according to patient's situation appearance curved surface by reverse engineering structure biomimetic prosthetic semi-articulation body, and utilize Three-dimensional Design Software to form the female mold and the Shell model of biomimetic prosthetic semiarthrosis, according to the cartilage of this semiarthrosis and the interface shape and the thickness data of osteoplaque osteoplaque is divided into upper strata (1), (3) three parts in middle level (2) and lower floor then; Design its inner tubing string minus structure respectively according to each layer function, be that upper strata (1) is mouse cage shape tubular column structure, the tubing string cross section is even regular texture, middle level (2) is a cavity structure, lower floor (3) has the tubular column structure that intersects vertically mutually, at last the Shell model of each layer model with artificial semiarthrosis merged, form the negative shape model of artificial semi-articulation body structure;
2) adopt the delamination software of rapidform machine self that negative shape model is carried out layering, lift height: 0.10mm, utilize precise light curing formation machine molding borrowed structure to bear the shape resin die according to the result after the layering;
3) ceramic powders, aqueous solvent, organic monomer, dispersant and cross-linking agent are compared mix homogeneously by the quality of 110-120: 60-80: 6-8: 1-2: 1-1.5, put into the vacuum machine and remove bubble, and make the PH=9 of mixture obtain slurry with the strong aqua ammonia adjustment, in slurry, add cross-linking agent quality 0.2-0.5 initiator and catalyst doubly more respectively and form ceramic slurry;
4) ceramic slurry is filled in the negative shape resin die of borrowed structure, and inserts in the high-temperature vacuum furnace and to be warming up to 800 ℃～1000 ℃ insulations from room temperature with 100 ℃/hour programming rate and to be cured in 1.5～2 hours, cool to room temperature then with the furnace and take out;
5) be made into polyurethane solutions by 8: 1 mass ratio with polyurethane with the corresponding consolidation liquid of polyurethane model;
6) polyurethane solutions is poured in the female mold, then the ceramic body with curing molding places polyurethane solutions, evacuation was placed 0.5 hour under the vacuum of 0.01～0.0005Mpa, placed under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 12～24 hours;
7) take out the interior semi-articulation body of mould, it is ceramic segment (4) that shaping promptly obtains the osteoplaque material, and the cartilage layers elastomeric material is the artificial semi-articulation body of polyurethane elastomer (5).
2, the manufacturing process of biomimetic prosthetic semi-articulation body according to claim 1 is characterized in that: the wavelength of the laser instrument of said precise light curing formation machine is 355nm; Spot diameter is 0.2mm; The filling scanning speed is 5000mm/s; Filling vectorial spacing is 0.10mm; The support scanning speed is 2000mm/s; The jumping speed of striding is 8000mm/s; Profile scan speed is 3000mm/s; The compensation diameter is 0.12mm; Worktable lifting speed is 4.00mm/s; It is 0.50ms that point supports sweep time; Stricture of vagina structure sweep time is 0.50ms.
3, the manufacturing process of biomimetic prosthetic semi-articulation body according to claim 1 is characterized in that: the tubular column structure of said lower floor (3) is tubing string orthohormbic structure or other bionical tubular column structures.
4, the manufacturing process of biomimetic prosthetic semi-articulation body according to claim 1 is characterized in that: said aqueous solvent is a deionized water; Ceramic powders is Beta-tricalcium phosphate (β-TCP), Alpha-tricalcium phosphate (α-TCP), hydroxyapatite (HAP), calcium carbonate or an aluminium oxide; Organic monomer is acrylamide, methyl-acyl-oxygen ethyl-trimethyl salmiac or adipic dihydrazide; Cross-linking agent is N, N-dimethylene diacrylamine, N, N-two acetonyl acrylamides or dibenzalacetone base acrylamide, dispersant is sodium polyacrylate or ammonium polyacrylate, initiator is Ammonium persulfate., sodium peroxydisulfate or potassium peroxydisulfate, and catalyst is N, N, N ' N '-tetramethylethylenediamine, N, N-dimethyl cyclohexyl amine or N, N, N ', N ", N " pentamethyl-diethylenetriamine.
5, a kind of biomimetic prosthetic semi-articulation body that obtains according to the manufacturing process of claim 1, it is characterized in that: comprise the ceramic segment (4) that contacts with bone and form to have the three-dimensional porous tubular column structure that promotes with implantation region sclerotin ankylose in the said ceramic segment (4) with polyurethane elastomer (5) two parts of joint contact; Polyurethane elastomer (5) is fixed on the ceramic segment by the mouse cage shape three-dimensional porous structure at ceramic segment (4) top.
CN 200710018461 2007-08-14 2007-08-14 Bionic artificial semi-joint body and manufacturing technique thereof Expired - Fee Related CN100528103C (en)

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