CN100577218C - Manufacturing method of artificial sclerite shaping implant made of polyvinyl plastics - Google Patents
Manufacturing method of artificial sclerite shaping implant made of polyvinyl plastics Download PDFInfo
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- CN100577218C CN100577218C CN200710170995A CN200710170995A CN100577218C CN 100577218 C CN100577218 C CN 100577218C CN 200710170995 A CN200710170995 A CN 200710170995A CN 200710170995 A CN200710170995 A CN 200710170995A CN 100577218 C CN100577218 C CN 100577218C
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Abstract
The present invention relates to a method for making a vinyon artificial bone fragment molding implant, and the method comprises the steps of: (a) preparing the raw material: filtrating the thin particle vinyon in initial state, the surface of the obtained particle has a plurality of prominent bulges which is irregular ellipse grain shape; (b) preparing the mold which is composed of a mold frame, a top mold board and a lower mold plate; (c) adding material: spreading the filtrated raw material uniformly in the mold cavity after weighting; (d) orientating the electrostatic: opening the electrical power switch of the electrostatic generator and adjusting the electrical voltage, executing slow horizontal moving scanning with the electrode bar at the voltage output end at the upper side of the mold, the upright particles inclines along with the moving direction of the electrode bar and the plastic particles are arranged with regulated cross net shape; (e) closing the mold cover and inputting the mold to the heating furnace to sinter when the process of the electrostatic orientating has finished. The artificial bone fragment made with the method of the invention has a cellular structure with a definite shape, facilitates the adhering and growing of the human organization, has an excellent bioavailability and physical property.
Description
Technical field
The present invention relates to the artificial osteocomma of bio-medical, particularly a kind of manufacture method that adopts the artificial osteocomma formation implant of polyethylene kind plastic production bio-medical.
Background technology
Medical treatment is at present gone up the bone rehablitation project and mainly is divided into artificial joint and bone grafting material two big classes.
In recent years, the Puli of the external advanced country such as the U.S. restrains this (POREX) company and adopts the polyethylene kind plastics, makes implants such as artificial bone and artificial eye pedestal as linear low density polyethylene (LLDPE), ultra-high molecular weight polyethylene (UHMWPE), high density polyethylene (HDPE) (HDPE) etc.These organic molecules of being made up of carbon, the simple atom of hydrogen when molecular weight reaches certain magnitude, can present good physics and chemical property by polymerization and crosslinked, have better biocompatibility and safety non-toxic simultaneously.It is said that domestic some R﹠D institution also did corresponding test, but in the application of slim osteocomma, exist some problem.
Artificial osteocomma has multi-cellular structure, thawing by plastic grain when molding is heated, between the accumulation plastic grain, be connected to form skeleton, because plastic grain is piled up under free state, the artificial osteocomma that forms in the plane the mechanical strength of each point exist very big difference and porosity inconsistent, (thickness only is under 1～2mm) the situation making thin slice, its reaction is particularly evident, operative doctor is when cutting profile, the phenomenon that the edge part branch generating unit of osteocomma divides plastic grain to come off will produce bigger medical hidden danger thus.
Bone grafting material tradition is used medical titanium alloy material and ceramic material, because its processing and forming difficulty, the elastic modelling quantity height implants and can't close with tissue generation chain, in conjunction with difficulty, causes becoming flexible and fails.Some new bone grafting materials have appearred at present, as the artificial bone of being made by inorganic material such as calcium hydroxy phosphates.This material has better biocompatibility, and can be made into microcellular structure.But this material is brittle state, and impact strength is poor, and it is then cracked easily to implant when laminating, it is fixing to carry out shape finishing and punching in surgical operation, therefore its operating difficulties can only occur with the shape of artificial bone piece, does not use and do not recommend to do laminar artificial bone.
Summary of the invention
Task of the present invention provides a kind of manufacture method of improved artificial sclerite shaping implant with polyvinyl plastics, it has solved and has traditionally existed processing and forming difficulty, elastic modelling quantity height as bone grafting material, combines difficulty with tissue with inorganic material such as medical titanium alloy material, ceramic material, calcium hydroxy phosphates, or is poor, the problem such as cracked easily that implants of laminating of fragility, impact strength.
Technical solution of the present invention is as follows:
A kind of manufacture method of artificial sclerite shaping implant with polyvinyl plastics, make by following processing step:
(a) preparation raw material: the fine-grained polyethylene plastics of original state are screened, the particle size that obtains is 800 μ m～250 μ m, through claim measurement with measuring cup and balance, particulate bulk density is 180g/L～280g/L, particle surface has the protuberance of several protrusions, is irregular ellipse grains shape;
(b) make mould: mould is made up of framed, cope match-plate pattern and lower bolster, upper and lower template and framed employing matched in clearance, and the gap is 0.1mm～0.2mm, and template is slided up and down in framed like a cork;
(c) reinforced: as die bottom plate to be placed in the die cavity, will after the raw material weighing of screening, to be spread in the die cavity equably, and evenly between charge period, mould is vibrated slightly, make between the feed particles of initial shape to be the free state arrangement with the scraper plate sheaing is smooth;
(d) static orientation: adopt high-voltage D.C. generator or electrostatic generator, its running voltage is 220V, output voltage is 20kV～80kV, and voltage output end is excellent portion, and voltage output end rod portion and electrostatic generator electric power connection line place are provided with an insulating segment for operator's holding operation;
Open the electrostatic generator on and off switch, adjust voltage, the electrode bar of voltage output end is moved horizontally scanning slowly above mould, the feed particulate material of observing this moment in the die cavity is subjected to the effect of electrode and makes material surface produce polarization, the arrangement that the raw material that former free state is stacked is produced between feed particles to reaction by the utmost point of generating positive and negative voltage is wriggled, and be the setting shape in the particle length direction, along with moving of electrode bar, the granule of erectting shape is also along with the electrode bar moving direction tilts, when taking away electrode bar, plastic grain still has electric charge, treats that electric charge reduces gradually after several minutes, and it is regularly arranged that plastic grain promptly is;
(e) treat that the static orientation process finishes after, the die cap that closes is put into heating furnace with mould and is carried out sintering.
By manufacture method of the present invention, the artificial osteocomma of making is a kind of bone grafting material of thin slice class of non-bearing type.This artificial osteocomma as base material, is made into the osteocomma of the band microcellular structure with definite shape with vinyon, is convenient to human tissue cell and adheres to and growth.In the subcutaneous rat Implantation Test in 26 weeks, in the time in 4 weeks, histiocyte can run through whole osteocomma, fully demonstrates excellent biological compatibility usually.
The present invention adopts the granule powder of vinyon such as linear low density polyethylene (LLDPE), ultra-high molecular weight polyethylene (UHMWPE) or high density polyethylene (HDPE) (HDPE), behind the high-pressure electrostatic molecularly oriented, the mold pressing thermoplastic shaping, therefore improved the tensile strength and the impact strength of goods, thereby obtained comprehensively to run through that porous, plastic grain are that regular cross network is arranged, elastic modelling quantity is near the artificial osteocomma of non-bearing natural bone.
Be mainly used in the repairing filling of facial bone among the plastic surgery, frontal bone, cheekbone and skull etc. by the artificial osteocomma of manufacture method making of the present invention.Artificial osteocomma adopts certain size and thickness, operative doctor is selected the cutting cutting according to patient's position, if the normal saline that needs band circular arc position osteocomma can be put into 95 ℃ soaked 5～10 minutes, treat to bend to after the osteocomma deliquescing required circular-arc, again osteocomma is put into the normal saline cooling and shaping of room temperature.Because osteocomma thickness requires usually between 1～6mm, therefore, except having excellent biological compatibility, also has excellent physical property, as tensile strength and impact strength etc. as the osteocomma of loose micropore flake structure.
The present invention is easy to make, will be with a wide range of applications in fields such as the transplanting of bio-medical bone, repairing bone.
The specific embodiment
The present invention is a kind of manufacture method of artificial sclerite shaping implant with polyvinyl plastics, adopts following process steps to make:
1, preparation raw material: the raw material of artificial osteocomma adopts vinyon, can select linear low density polyethylene (LLDPE) for use, perhaps ultra-high molecular weight polyethylene (UHMWPE), perhaps high density polyethylene (HDPE) (HDPE); Also can select the mixture of linear low density polyethylene (LLDPE), ultra-high molecular weight polyethylene (UHMWPE) and high density polyethylene (HDPE) (HDPE) for use.
These materials are fine grain in original state, and the fine-grained polyethylene plastics are screened, and the particle size that obtains is 800 μ m～250 μ m, are preferably 600 μ m～350 μ m.By adopting measuring cup and balance to claim to measure, particulate bulk density is 180g/L～280g/L.Adopt 8 times of magnifieres to observe, particle surface has the protuberance of several protrusions, is irregular ellipse grains shape, and the ridge rough surface that protrudes, and with the floccule of a small amount of wire drawing shape.
2, make mould: mould is made up of three parts, promptly framed, cope match-plate pattern and lower bolster.Consider the magnetic field orientating of high-pressure electrostatic, the framed material in the mould is made by polytetrafluoroethylene (PTFE), but this material is at life-time service below 250 ℃; Cope match-plate pattern in the mould and lower bolster are made by stainless steel materials 1Cr18Ni9Ti, and sheet metal thickness is selected 6～10mm for use, so that conduction of heat.Upper and lower template and framed employing matched in clearance, the gap is 0.1mm～0.2mm, and template is slided up and down in framed more like a cork.
3, reinforced: that die bottom plate is placed in the die cavity, to after the raw material weighing of screening, be spread in the die cavity equably, and with scraper plate that the raw material sheaing is smooth evenly, between charge period, mould can be vibrated slightly, make to be free state between the feed particles of initial shape and to arrange.
4, static orientation: adopt high-voltage D.C. generator or electrostatic generator, its running voltage is 220V, and output voltage is 20～80kV.The output voltage of high-voltage D.C. generator or electrostatic generator is preferably 50kV～60kV.Voltage output end is bar-shaped, and its length is slightly larger than die cavity.Voltage output end rod portion and electrostatic generator electric power connection line place are provided with an insulating segment, so that operator's holding operation.
Open the electrostatic generator on and off switch, voltage output end promptly produces high-pressure electrostatic, adjusts voltage to 50kV～60kV, and the electrode bar that is about to voltage output end moves horizontally scanning slowly above mould; The feed particulate material that can be observed this moment in the die cavity is subjected to the effect of electrode and makes material surface produce polarization, and the arrangement that the raw material that former free state is stacked is produced between feed particles to reaction by the utmost point of generating positive and negative voltage is wriggled, and is the setting shape in the particle length direction; Along with moving of electrode bar, the granule of erectting shape is also along with the electrode bar moving direction tilts; When taking away electrode bar, plastic grain still has certain electric charge, treats that (for example 5 minutes) electric charge reduces gradually after several minutes, can see significantly this moment, the plastic grain of erectting shape lodges in proper order and presents necessarily regularly arrangedly, has so just reached the purpose that static is orientated.
The distance of electrode bar 30mm～80mm above mould of static orientation moves horizontally scanning highly slowly, and this distance highly is preferably 40mm～70mm.The electrode bar translational speed of static orientation is controlled at 0.15m/min～0.3m/min, its moving direction alternately moves at the vertical and horizontal of mould respectively, stop 5～10 minutes between each orientation that alternately moves, replace mobile number of times for vertically with laterally each 2～3 times, to reach the good granule state that interweaves.
5, treat that the static orientation process finishes after, the die cap that closes is put into heating furnace with mould and is carried out sintering.In heating process, can replenish nitrogen (N in the heating furnace
2) wait noble gas, to reduce the degree of oxidation of product surface.
Manufacture method of the present invention adopts the processing step of static orientation, carries out the high-pressure electrostatic orientation when die cavity Nei Shibu plastic grain raw material, by the intergranular interaction of electromagnetic field, with the condition that obtains to align.The static orientation adopts the similar scan method of high voltage electrostatic rod, and from the adjacent both sides of mould difference cross scan several times, the arrangement of orientation back plastic grain presents the cross network structure with rule row.To put into the heating furnace sintering behind the mould matched moulds, strict control temperature and pressure make the mode gradually fusion of plastic grain with inherently stable, and by well-regulated connection moulded products between granule.Especially molding sheet thickness is the artificial bone sheet articles of the conduct of δ=1mm by the inventive method, through the static orientation, when comparing, on the result of the test of tensile strength and impact strength, improved more than 15% respectively with the control sample that is orientated without static.
The artificial osteocomma that the present invention adopts the high-pressure electrostatic method for alignment to make detects through inspection center of Shanghai Plastic Inst. and inspection center of Shanghai Inst. of Materials, and the detection destination data is as follows:
Above testing result shows, sample of the present invention through orientation process is compared with the control sample that not oriented is handled, on the Main physical index, the former is significantly improved than the latter, especially tensile strength and impact strength have all improved more than 15%, modulus of elasticity in comperssion is reduced significantly, it only is 2.5 ‰ of the present medical titanium metal (200GMP) that uses, for common ultra-high molecular weight polyethylene (about 40% of 1300MPa～1500MPa), more approaching with the elastic modelling quantity of human body bone.Impact strength is that the calcium hydroxy phosphate inorganic material is made artificial bone (0.2KJ/m
2～0.5KJ/m
2) more than 20 times.
Artificial osteocomma sample of the present invention as formation implant in the subcutaneous rat Implantation Test, detect through 4 weeks, 12 weeks, 26 time-of-weeks respectively, and sampling is observed respectively, each phase tissue reaction's degree of sample is identical with the negative control product, the marginal portion does not have particulate material yet and is scattered during cutting sampling, has obtained the design result of use of expection.
Manufacture method by artificial sclerite shaping implant with polyvinyl plastics of the present invention in the process of experimentizing, has adopted linear high-density polyethylene (LLDPE) respectively to selecting for use of raw material, and model is DNDC-7150; Ultra-high molecular weight polyethylene (UHMWPE), model are HD450; High density polyethylene (HDPE) (HDPE), model are DMDY-1158.Its material is screened respectively, and the particle size of employing is 400 μ m～500 μ m.When above-mentioned particulate material heats in heating furnace, behind melt surface,, impose suitable pressure again and can form needed osteocomma size shape by the intergranular bonding skeleton that forms.Osteocomma takes out after cooling off and observes, can see and be full of micropore in the osteocomma, these micropores can reduce the elastic modelling quantity of this material, with elastic modelling quantity near natural person's bone, micropore is convenient to the inside growth of tissue behind the artificial osteocomma implant into body of conduct, to reach the better tissues compatibility.
Certainly in concrete experiment processing,, should select different heating-up temperatures, heat time heating time, briquetting pressure and mould respectively for use according to the difference of raw-material difference and goods.The HV generator that is adopted for example model is JIA-02, and its output voltage is 0～70kV, regulates in 30kV～65kV scope usually.
Further describe four experimental examples below:
Experimental example 1
Base plate is installed in the rectangle of a 120 * 100mm is framed, the linear low density polyethylene (LLDPE) of about 10g is put in weighing then, the raw material model is DNDC-7150, by vibration, wipe technology off, the high pressure torch is adjusted to 50kV, highly be in vertical apart from raw material 50mm, each cross scan secondary of transverse direction, finish the static orientation process, cover cope match-plate pattern, put into heating furnace and carry out heat-agglomerating, the 0.12MPa that on cope match-plate pattern, exerts pressure during heating, heating-up temperature is between 140 ℃～180 ℃, and the time is 60～105 minutes, then mould is taken out from heating furnace, be placed on and naturally cool in the room temperature about 60 ℃, last depanning can obtain the thin slice of 1mm left and right thickness.
Experimental example 2
Base plate is installed in the rectangle of a 120 * 100mm is framed, the ultra-high molecular weight polyethylene (UHMWPE) of about 20g is put in weighing then, the raw material model is HD450, by vibration, wipe technology off, the high pressure torch is adjusted to 60kV, highly be in vertical apart from raw material 70mm, each cross scan secondary of transverse direction, finish the static orientation process, cover cope match-plate pattern, put into heating furnace and carry out heat-agglomerating, the 0.25MPa that on cope match-plate pattern, exerts pressure during heating, heating-up temperature is between 160 ℃～225 ℃, and the time is 90～120 minutes, then mould is taken out from heating furnace, be placed on and naturally cool in the room temperature about 80 ℃, last depanning can obtain the thin slice of 2mm left and right thickness.
Experimental example 3
Base plate is installed in the rectangle of a 120 * 100mm is framed, the high density polyethylene (HDPE) (HDPE) of 30g is put in weighing then, the raw material model is DMDY-1158, by vibration, wipe technology off, the high pressure torch is adjusted to 40kV, highly be in vertical apart from raw material 40mm, each cross scan secondary of transverse direction is finished the static orientation process, covers cope match-plate pattern, put into heating furnace and carry out heat-agglomerating, the 0.1MPa that on cope match-plate pattern, exerts pressure during heating, heating-up temperature is between 150 ℃～190 ℃, and the time is 70～110 minutes, then mould is taken out from heating furnace, be placed on and naturally cool in the room temperature about 50 ℃, last depanning can obtain the thin slice of 3mm left and right thickness.
Experimental example 4
Base plate in being φ 145mm circular framed, is installed an internal diameter, the raw material (this raw material by the UHMWPE of 50% LLDPE and 50% through fully mixing) of about 58g is put in weighing then, by vibration, wipe technology off, the high pressure torch is adjusted to 65kV, highly locate to scan apart from raw material 60mm, scan respectively from three directions of 120 ° of the framed center of circle of circle angles, finish the static orientation process, cover upper mould cover, put into heating furnace and carry out heat-agglomerating, the 0.25MPa that on cope match-plate pattern, exerts pressure during heating, heating-up temperature is between 170 ℃～220 ℃, and the time is 80～110 minutes, then mould is taken out from heating furnace, be placed on and naturally cool in the room temperature about 60 ℃, last depanning can obtain the thin slice about 4mm.
Certainly, those skilled in the art in the present technique field will be appreciated that, the foregoing description only is to be used for illustrating the present invention, and be not as limitation of the invention, as long as in connotation scope of the present invention, all will drop in the scope of claim of the present invention conversion, the modification of the foregoing description.
Claims (9)
1. the manufacture method of an artificial sclerite shaping implant with polyvinyl plastics is characterized in that, makes by following processing step:
(a) preparation raw material: the fine-grained polyethylene plastics of original state are screened, the particle size that obtains is 800 μ m～250 μ m, through claim measurement with measuring cup and balance, particulate bulk density is 180g/L～280g/L, particle surface has the protuberance of several protrusions, is irregular ellipse grains shape;
(b) make mould: mould is made up of framed, cope match-plate pattern and lower bolster, upper and lower template and framed employing matched in clearance, and the gap is 0.1mm～0.2mm, and template is slided up and down in framed like a cork;
(c) reinforced: as die bottom plate to be placed in the die cavity, will after the raw material weighing of screening, to be spread in the die cavity equably, and evenly between charge period, mould is vibrated slightly, make between the feed particles of initial shape to be the free state arrangement with the scraper plate sheaing is smooth;
(d) static orientation: adopt high-voltage D.C. generator or electrostatic generator, its running voltage is 220V, output voltage is 20kV～80kV, and voltage output end is excellent portion, and voltage output end rod portion and electrostatic generator electric power connection line place are provided with an insulating segment for operator's holding operation;
Open the electrostatic generator on and off switch, adjust voltage, the electrode bar of voltage output end is moved horizontally scanning slowly above mould, the feed particulate material of observing this moment in the die cavity is subjected to the effect of electrode and makes material surface produce polarization, the arrangement that the raw material that former free state is stacked is produced between feed particles to reaction by the utmost point of generating positive and negative voltage is wriggled, and be the setting shape in the particle length direction, along with moving of electrode bar, the granule of erectting shape is also along with the electrode bar moving direction tilts, when taking away electrode bar, plastic grain still has electric charge, treats that electric charge reduces gradually after several minutes, and it is regularly arranged that plastic grain promptly is;
(e) treat that the static orientation process finishes after, the die cap that closes is put into heating furnace with mould and is carried out sintering.
2. the manufacture method of artificial sclerite shaping implant with polyvinyl plastics according to claim 1, it is characterized in that, described vinyon is selected linear low density polyethylene LLDPE for use, perhaps ultra-high molecular weight polyethylene UHMWPE, perhaps high density polyethylene.
3. the manufacture method of artificial sclerite shaping implant with polyvinyl plastics according to claim 1, it is characterized in that described vinyon is selected the mixture of linear low density polyethylene LLDPE, ultra-high molecular weight polyethylene UHMWPE and three kinds of raw materials of high density polyethylene for use.
4. the manufacture method of artificial sclerite shaping implant with polyvinyl plastics according to claim 1 is characterized in that, the particle size of described fine-grained polyethylene plastics after screening is preferably 600 μ m～350 μ m.
5. the manufacture method of artificial sclerite shaping implant with polyvinyl plastics according to claim 1 is characterized in that, framed in the described mould made by polytetrafluoroethylene PTFE.
6. the manufacture method of artificial sclerite shaping implant with polyvinyl plastics according to claim 1 is characterized in that, cope match-plate pattern in the described mould and lower bolster are made by stainless steel materials 1Cr18Ni9Ti.
7. the manufacture method of artificial sclerite shaping implant with polyvinyl plastics according to claim 1 is characterized in that, the output voltage of described high-voltage D.C. generator or electrostatic generator is preferably 50kV～60kV.
8. the manufacture method of artificial sclerite shaping implant with polyvinyl plastics according to claim 1 is characterized in that, the distance of electrode bar 30mm～80mm above mould of described static orientation moves horizontally scanning highly slowly.
9. the manufacture method of artificial sclerite shaping implant with polyvinyl plastics according to claim 1, it is characterized in that, the electrode bar translational speed of described static orientation is controlled at 0.15m/min～0.3m/min, its moving direction alternately moves at the vertical and horizontal of mould respectively, stop 5～10 minutes between each orientation that alternately moves, replace mobile number of times for vertically with laterally each 2～3 times, to reach the good granule state that interweaves.
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| CN101746007B (en) * | 2008-12-11 | 2012-05-23 | 上海超高工程塑料有限公司 | Rotary rotational molding forming and manufacturing method for artificial eye pedestal implant |
| AU2011264850B2 (en) | 2010-06-08 | 2016-03-03 | Smith & Nephew, Inc. | Implant components and methods |
| PL2750725T3 (en) * | 2011-09-01 | 2021-05-17 | Anatoli D. Dosta | Dental implant, vascular implant and tissue implant made of porous three-dimensional structure of polytetrafluoroethylene |
| JP6258226B2 (en) * | 2012-02-10 | 2018-01-10 | シンセス・ゲーエムベーハーＳｙｎｔｈｅｓ ＧｍｂＨ | Porous implant materials and related methods |
| CN103272277B (en) * | 2013-05-28 | 2015-04-08 | 北京博辉瑞进生物科技有限公司 | Mold for preparing accellular small intestine submucosa matrix material |
| CN103272273B (en) * | 2013-05-28 | 2015-04-08 | 北京博辉瑞进生物科技有限公司 | Mold for preparing accellular small intestine submucosa matrix material |
| CN106362204A (en) * | 2016-08-30 | 2017-02-01 | 何仁英 | High-strength artificial bone material and preparation method thereof |
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