The preparation method of artificial joint prosthesis with partially controllable porous structure
Technical field
What the present invention relates to is artificial joint of a kind of technical field of medical instruments and preparation method thereof, is specifically related to a kind of preparation method of artificial joint prosthesis with partially controllable porous structure.
Background technology
The prosthetic replacement repairs the destruction of joint that causes because of disease or tumor, removes arthralgia, deformity and dysfunction, rebuilds a function near joint normally.At present, artificial joint replacement, particularly artificial hip joint and total knee replacement are considered to the very sure Therapeutic Method of effect.Because prosthese implants for a long time, ideal prosthetic material should have enough intensity, toughness and resisting fatigue, resistance to wear, and should have excellent biological compatibility simultaneously, has no side effect.At present, the main material that the artificial prosthesis handle uses is metal material, comprises rustless steel, cochrome, titanium and alloy thereof.These metal materials all have the good mechanical performance, behind the implant into body, can satisfy stressed requirement in patient's daily behavior active procedure.Wherein, because titanium and alloy thereof not only have good biomechanical property, and possess excellent biological compatibility, therefore use the most extensive.Late 1970s, prosthese biology, fixing the rise mainly was to utilize the bone prosthetic surface micropore of growing into, and fixedly secured thereby reach.Surface at prosthese makes loose structure, for growing into of cell, tissue provides the space, promotes the ankylose of cambium and prosthese, realizes biological fixation, is a focus of studying both at home and abroad in recent years.Studies show that the pore structure of prosthetic surface directly affects the formation of growing into of tissue and new bone.Suitable pore structure (size, shape, distribution, space trend and the interconnection that comprise the hole) helps the formation and the revascularization of new bone tissue.
At present, the main method at prosthetic surface manufacturing loose structure has sintering and plasma spraying technology.Wherein, plasma spraying technology is the method that present a kind of part in prosthetic surface of generally adopting prepares loose structure.This technology is to adopt plasma arc as thermal source, and metal material is heated to fusion or semi-molten state, and to spray to the method that forms the surface layer of adhesion-tight through pretreated surface of the work at a high speed, belongs to the high-temperature heat treatment technology.In the process of prosthetic surface spray metal powder, because action of high temperature, the mechanical property of prosthese itself will be affected, and causes the reduction of prosthese mechanical property, ruptures easily after replacing human body.And prepared hole is very irregular, can't guarantee the interconnection between the hole.Therefore, under the prerequisite that does not reduce the mechanical property of prosthese own, make up prosthetic surface pore structure local rule, that be interconnected, for growing into of cell, tissue provides the space, promote the ankylose of cambium and prosthese, have important engineering meaning and clinical value.
Find by prior art documents, application number: 200610046258.0, publication number: CN101049516 title: " a kind of imbedded body in porous titanium of biologic medical use and preparation method thereof ", being a kind of imbedded body in porous titanium of biologic medical use and preparing the imbedded body in porous titanium of biologic medical use method of this disclosure of the Invention with titanium silk or titanium alloy wire, this method can only be made the simple porous implant of profile, be difficult to produce complex-shaped human synovial profile, and the porous implant maximum load-carrying capacity of manufacturing has only 300MPa, with use the intensity of titanium prosthese to differ greatly clinically at present, fracture appears easily behind the implant into body.
Summary of the invention
The objective of the invention is at the deficiencies in the prior art, a kind of preparation method of artificial joint prosthesis with partially controllable porous structure is provided, make it overcome the deficiency of the mechanical property of damage prosthese in the existing preparation artificial joint prosthesis porous surface configuration process own, make up controlled pore structure, for growing into of cell, tissue provides suitable space structure, promote the ankylose of cambium and articular prosthesis, realize the biological fixation of prosthese.
The present invention is achieved by the following technical solutions:
The present invention includes following steps:
The first step, according to helping cell, organizing the principle of growing into, utilize commercialization CAD software, as: Unigraphix, Pro/E, Catia etc., the design cell structure, its pore-size is designed to 200-1000 μ m, and designed porosity is 50%-90%, be interconnected fully between the hole, designed cell structure cad data is stored as the stl file form;
Second step, above-mentioned cell structure cad model is input to rapid forming system, this system is mainly used in the scanning pattern of control electron beam, utilize Materialise ' the s Magics software in this system that cad data is carried out the hierarchy slicing processing, obtain the two-dimensional signal data of cell structure, and carry out the quick shaping manufacturing;
Described quick shaping manufacturing, be specially: powder feeding mechanism is with powder body material, as: titanium and alloy powder thereof, the vitallium powder, deliver to presumptive area, powder mechanism paves powder body and compacting by the shop, then, electron beam scans according to the two-dimensional signal data that obtained under computer control, fusing sintering powder body material, and then powder feeding, the shop powder, fusing sintering powder body repeats this process, up to forming whole test specimen, make good test specimen and be placed on slowly cooling in the powder body heap in the vacuum chamber, take out, further be cooled to remove after the room temperature and be stained with the unnecessary powder body that is bonded on the test specimen.
Described cooling is meant that temperature reduces to 150 ℃.
Described quick shaping manufacturing, its basic technology parameter is as follows: processing bed thickness 0.1mm, scanning speed 300m/s, beam power 4kW, vacuum is 5 * 10
-4MBar.
Rapid Prototyping technique is existing a kind of advanced manufacturing technology.Technological parameter in this step does not have specific requirement, makes according to the parameter of quickly shaping device acquiescence.Rapid forming system is a control system, mainly is to be used for that cad data is carried out hierarchy slicing to handle and control the electron beam scanning path.
The 3rd step, utilize laser welding technology, above-mentioned controllable porous structure body is welded on precalculated position on the articular prosthesis, form and have high-strength mechanical properties and artificial joint prosthesis with partially controllable porous structure.
Compare with the artificial joint prosthesis of plasma spraying technology preparation; the artificial joint prosthesis with partially controllable porous structure of the present invention's preparation; the pore structure characteristic and the project organization of its cell structure are in full accord; be according to helping cell; the principle design that tissue is grown into; therefore; be particularly suitable for cell; tissue is grown into; be convenient to realize the biological fixation of prosthese; its mechanical property can be by the adjustment apertures rate; accomplish with people's osseous tissue very approaching, and, taked the manufacturing process of multiple step format; direct metal quick shaping manufacturing process is separated with assembly technology, can be good at protecting the original high-strength mechanical properties of prosthese handle.
The present invention adopts the electron-beam melting forming technology of one of cad technique and direct metal Rapid Prototyping technique, manufacture and design the partial cell structure of prosthese, can design the three-D space structure of cell structure as required in advance, and realize the accurate control of manufacture process by Rapid Prototyping technique, obtain to be fit to cell easily, the pore structure characteristic that tissue is grown into, then, adopt laser welding technology, under the prerequisite of not damaging the mechanical property of prosthese own, prepared controllable porous structure body is welded on the predetermined position of articular prosthesis, formation has the artificial joint prosthesis of high-strength mechanical properties and partially controllable porous structure, can be applicable to the reparation of joint injury clinically.
Description of drawings
Fig. 1 is a structural representation of the present invention;
Fig. 2 is a controllable porous structure body sketch map.
The specific embodiment
Below in conjunction with accompanying drawing embodiments of the invention are elaborated: following examples are being to implement under the prerequisite with the technical solution of the present invention; provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
As shown in Figure 1, 2, the prosthese in following examples comprises: prosthese handle 1, controllable porous structure body 2, controllable porous structure body 2 are welded on the default position of prosthese handle 1, form the artificial joint prosthesis of partially controllable porous structure.
Described controllable porous structure body 2 comprises: controlled pore structure 3, can be designed and manufactured into cellular, three-dimensional orthogonal structure, gradient pore structured etc., and support unit body 4, its porosity is at 50%-90%.Its pore-size is 200-1000 μ m.
Below provide embodiments of the invention in detail:
Embodiment 1
At first according to helping cell, organizing the basic principle of growing into, utilize commercialization CAD software Unigraphix to design cellular porous structure, its pore-size is 200 μ m, porosity is 50%, be interconnected fully between the hole, designed cell structure cad model is stored with the stl file form; The STL data are input to rapid forming system, carry out hierarchy slicing and handle, obtain the two-dimensional signal data of cell structure; Carry out the manufacturing of direct metal quick shaping then, by powder feeding mechanism with Ti6Al4V alloy powder material, deliver to presumptive area, shop powder mechanism paves powder body and compacting, then, electron beam scans according to the two-dimensional signal data that obtained under computer control, fusing sintering powder body material, and then powder feeding, shop powder, fusing sintering powder body, repeat this process, up to forming whole test specimen, the basic technology parameter of manufacture process is as follows: processing bed thickness 0.1mm, scanning speed 300m/s, beam power 4kW, vacuum is 5 * 10
-4MBar.Make good cell structure and be placed on slowly cooling in the powder body heap in the vacuum chamber, treat to take out after temperature is reduced to 150 ℃, the unnecessary powder body that is bonded on the cell structure is stained with in removal after further being cooled to room temperature, thereby obtains and on all four titanium of project organization and alloy cell structure thereof; At last, utilize laser welding technology, above-mentioned cell structure is welded on precalculated position on the artificial joint prosthesis, form artificial joint prosthesis with partially controllable porous structure.
Embodiment 2
At first according to helping cell, organizing the basic principle of growing into, utilize commercialization CAD software Unigraphix to design cellular porous structure, its pore-size is 600 μ m, porosity is 70%, be interconnected fully between the hole, designed cell structure cad model is stored with the stl file form; The STL data are input to rapid forming system, carry out hierarchy slicing and handle, obtain the two-dimensional signal data of cell structure; Carry out the manufacturing of direct metal quick shaping then, by powder feeding mechanism with Ti6Al4V alloy powder material, deliver to presumptive area, shop powder mechanism paves powder body and compacting, then, electron beam scans according to the two-dimensional signal data that obtained under computer control, fusing sintering powder body material, and then powder feeding, shop powder, fusing sintering powder body, repeat this process, up to forming whole test specimen, the basic technology parameter of manufacture process is as follows: processing bed thickness 0.1mm, scanning speed 300m/s, beam power 4kW, vacuum is 5 * 10
-4MBar.Make good cell structure and be placed on slowly cooling in the powder body heap in the vacuum chamber, treat to take out after temperature is reduced to 150 ℃, the unnecessary powder body that is bonded on the cell structure is stained with in removal after further being cooled to room temperature, thereby obtains and on all four titanium of project organization and alloy cell structure thereof; At last, utilize laser welding technology, above-mentioned cell structure is welded on precalculated position on the artificial joint prosthesis, form artificial joint prosthesis with partially controllable porous structure.
Embodiment 3
At first according to helping cell, organizing the basic principle of growing into, utilize commercialization CAD software Unigraphix to design cellular porous structure, its pore-size is 1000 μ m, porosity is 90%, be interconnected fully between the hole, designed cell structure cad model is stored with the stl file form; The STL data are input to rapid forming system, carry out hierarchy slicing and handle, obtain the two-dimensional signal data of cell structure; Carry out the manufacturing of direct metal quick shaping then, by powder feeding mechanism with Ti6Al4V alloy powder material, deliver to presumptive area, shop powder mechanism paves powder body and compacting, then, electron beam scans according to the two-dimensional signal data that obtained under computer control, fusing sintering powder body material, and then powder feeding, shop powder, fusing sintering powder body, repeat this process, up to forming whole test specimen, the basic technology parameter of manufacture process is as follows: processing bed thickness 0.1mm, scanning speed 300m/s, beam power 4kW, vacuum is 5 * 10
-4MBar.Make good cell structure and be placed on slowly cooling in the powder body heap in the vacuum chamber, treat to take out after temperature is reduced to 150 ℃, the unnecessary powder body that is bonded on the cell structure is stained with in removal after further being cooled to room temperature, thereby obtains and on all four titanium of project organization and alloy cell structure thereof; At last, utilize laser welding technology, above-mentioned cell structure is welded on precalculated position on the artificial joint prosthesis, form artificial joint prosthesis with partially controllable porous structure.
The prepared artificial joint prosthesis of the present invention can obtain the porous metal structure body consistent with project organization, thereby helps growing into of cell, tissue.