CN1381278A - Adsorbable internal fixing material for bone fracture and its preparing process - Google Patents
Adsorbable internal fixing material for bone fracture and its preparing process Download PDFInfo
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- CN1381278A CN1381278A CN 02113025 CN02113025A CN1381278A CN 1381278 A CN1381278 A CN 1381278A CN 02113025 CN02113025 CN 02113025 CN 02113025 A CN02113025 A CN 02113025A CN 1381278 A CN1381278 A CN 1381278A
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- adsorbable
- bone fracture
- hydroxyapatite
- internal fixing
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Abstract
An absorbable internal fixing material for bone fracture is prepared from polylactic acid (50-90 wt.%), tricalcium phosphate (1-40 wt.%) and hydroxylapatitie (1-40 wt.%) through mixing then and then hot die pressing at 80-1230 deg.C and under 0.11-25 MPa or hot extruding at 80-230 deg.c. The granulality of hydroxylapatite and tricalcium phosphate is less than 100 microns. Its advantages are high strength, high strength, high X-ray visualization and high biocompatibility.
Description
One, technical field:
The present invention be a kind of can absorbed bone fracture internal fixation material and preparation method thereof, belong to the technical field of medical science surgery with material preparation.
Two, background technology:
Internal fixation device is orthopaedics therapy fracture, the indispensable medical apparatus and instruments of bone wound.Bone fracture internal fixing device commonly used at present has metal material maybe can absorb macromolecular material.By the inner fixer intensity height that rustless steel or titanium alloy are made, cost is lower, and frequency of utilization is very high.The subject matter of this class nail is need carry out second operation after the union of fracture and take out; Secondly, because stress-shielding effect causes bone resorption probably, osteanabrosis the secondary fracture easily takes place, and the initial stage knitting of making delays; Histocompatibility is bad, can cause inflammatory reaction etc.
But by the internal fixation device of bio-absorbable macromolecular material preparation, need not second operation and take out, be difficult for taking place bone resorption and osteanabrosis.But, because progressively degrading, macromolecular material produces acid micromolecular compound in body, the non-bacterial inflammatory reaction appears in some patients.On the other hand, the absorbed inner fixer strength character and the speed of fracture union of polylactic acid preparation are inharmonious, and intensity does not reach requirement.Another problem is that inner fixer does not have X-ray Presentation Function, external degraded and the absorption process that is difficult to observe inner fixer.
In order to improve the performance that can absorb inner fixer, there is the people that hydroxyapatite is mixed with macromolecular material, this material not only has higher intensity, and has X-ray Presentation Function.But the bio-absorbable performance of hydroxyapatite (HAP) is not so good, may influence the function of healing bone, and because the biodegradation of HAP is slow, is disadvantageous to the inflammatory reaction of eliminating inner fixer.
The somebody with tricalcium phosphate with can absorb macromolecular material and be mixed with bone renovating material, the intensity height of the strength ratio straight polymer material of this composite, and tricalcium phosphate has bio-absorbable performance preferably, composite has better biocompatibility.
Three, summary of the invention:
(1) goal of the invention
The purpose of this invention is to provide a kind of adsorbable bone folding inner fixer and preparation method thereof with high strength, X-ray display performance and biocompatibility.
(2) technical scheme
The preparation method of adsorbable bone folding inner fixer of the present invention.This material comprises polylactic acid, tricalcium phosphate, hydroxyapatite, wherein counts by weight percentage, and polylactic acid accounts for 50%～90% of material gross weight, and tricalcium phosphate accounts for 1%～40% of material gross weight, and hydroxyapatite accounts for 1%～40% of material gross weight; Polylactic acid be L-lactic acid or poly-(D, L)-lactic acid or this both mixture or L-lactic acid-(D, L)-lactic acid copolymer, the molecular weight of polylactic acid is 150,000～1,500,000; The granularity of hydroxyapatite and tricalcium phosphate is less than 100 microns; The method of preparation is: polylactic acid, tricalcium phosphate, hydroxyapatite are mixed, then through hot moulding or hot-extrudable making; The materials processing temperature of hot moulding is 80 ℃～230 ℃, and the pressure of hot moulding is 0.11～25MPa; Hot-extrudable materials processing temperature is 80 ℃～230 ℃.
(3) technique effect
(1) the present invention compared with prior art has following advantage:
(2) internal fixation material provided by the invention has higher intensity, and the characteristics that the X-ray shows are easy to absorbing features, and its bending strength reaches 100～300MPa, and bending modulus reaches 1～15GPa.Implanting to human body can be fixed fracture effectively.The clinical reparation that is used to fracture all will obtain good effect.
(3) the present invention adopts mold pressing or extrusion molding to process, and equipment is simple, processing ease, and cost is low.
(4) the present invention adopts tricalcium phosphate, hydroxyapatite mixture as reinforcing material, can effectively improve the intensity of inner fixer.Obtain the inner fixer of various varying strength requirements, can satisfy clinical various needs.
(5) the present invention adopts tricalcium phosphate as main reinforcing material, has improved the biological degradation function of inner fixer, and the inflammatory reaction of control material improves biocompatibility effectively.
(6) the present invention adopts hydroxyapatite as a kind of reinforcing material, not only has the induced osteogenesis effect, and makes inner fixer have the X-ray Presentation Function similar to the body osseous tissue, is convenient to clinical observation.It is synthetic that the hydroxyapatite that granularity is little can participate in bone, accelerates knitting.
Four, the specific embodiment
The present invention is to be raw material with polylactic acid, tricalcium phosphate and hydroxyapatite.
Above-mentioned polylactic acid is that ring-opening polymerisation obtains polylactic acid, comprises poly (l-lactic acid), poly-(D, L)-lactic acid, or both blends or L-lactic acid-(D, L)-lactic acid copolymer, the molecular weight of polymer is 15～1,500,000.
Above-mentioned tricalcium phosphate and hydroxyapatite are synthetic by wet method.Raw material drying, ball mill pulverizing obtain the pulverulent material that granularity is 50 nanometers-100 micron.Can be easy to obtain granularity through ball mill pulverizing is powder tricalcium phosphate and hydroxyapatite about 100 nanometers.
The present invention passes through mechanical mixture with polylactic acid, tricalcium phosphate, hydroxyapatite, and perhaps the precipitation mixing obtains composite.
Above-mentioned prepared composite is added in the mould, be heated to uniform temperature, suitable temperature range is 80～230 ℃, only temperature range is 150～220 ℃, best temperature range is 180～210 ℃, is forced into certain pressure then, and suitable pressure limit is 0.11～25MPa, pressure limit is 1～10MPa preferably, and best pressure limit is 2～5MPa.Obtain club-shaped material through compression molding.
Perhaps above-mentioned prepared composite is added in the extruder and processes, extrude and obtain club-shaped material.The temperature range that extruder barrel is suitable is 140～230 ℃.
The club-shaped material that is made by said method is heated to uniform temperature, is injected in the mold cavity through extruding, and the temperature of mold cavity is at 30-120 ℃, and temperature range is 50-100 ℃ preferably.
The lateral dimension of above-mentioned die cavity is littler than club-shaped material diameter.The composite that injects die cavity obtains high strength bar or flaky material through cooling.After machining, obtain high-intensity bone fracture internal fixation material.
For example be about 600,000 poly (l-lactic acid) with 20 gram particles directly be that tricalcium phosphate and 10 gram particles about 1 micron directly are that 1 micron left and right sides hydroxyapatite adopts the sedimentation method to mix with 70 gram-molecular weights, obtain composite, this material is pulverized, joined in the die cavity that diameter is 15mm.The die cavity temperature is heated to 190 ℃.Carry out mold pressing, molding pressure is 10MPa, pressurize 10 minutes, and cooling obtains preforming material.
Above-mentioned preforming material is joined in the mold cavity, the die cavity temperature is heated to 80 ℃.Carry out mold pressing, molding pressure is 10MPa, pressurize 10 minutes, and cooling obtains moulding material.
Above-mentioned moulding material is carried out machining obtain nail.
Claims (6)
1, a kind of adsorbable internal fixing material for bone fracture, make by materials such as hydroxyapatite, it is characterized in that this material comprises polylactic acid, tricalcium phosphate, hydroxyapatite, wherein count by weight percentage, polylactic acid accounts for 50%～90% of material gross weight, tricalcium phosphate accounts for 1%～40% of material gross weight, and hydroxyapatite accounts for 1%～40% of material gross weight.
2, adsorbable internal fixing material for bone fracture according to claim 1, it is characterized in that polylactic acid be poly (l-lactic acid) or poly-(D, L)-lactic acid or this both mixture or L-lactic acid-(D, L)-lactic acid copolymer, the molecular weight of polylactic acid is 150,000～1,500,000.
3, adsorbable internal fixing material for bone fracture according to claim 1, the granularity that it is characterized in that hydroxyapatite and tricalcium phosphate is less than 100 microns.
4, a kind of preparation method that is applicable to the adsorbable internal fixing material for bone fracture of claim 1 is characterized in that the method for preparing is: polylactic acid, tricalcium phosphate, hydroxyapatite are mixed, then through hot moulding or hot-extrudable making.
5, the preparation method of adsorbable internal fixing material for bone fracture according to claim 4, the materials processing temperature that it is characterized in that hot moulding are 80 ℃～230 ℃, and the pressure of hot moulding is 0.11～25MPa.
6, the preparation method of adsorbable internal fixing material for bone fracture according to claim 4 is characterized in that hot-extrudable materials processing temperature is 80 ℃～230 ℃.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02113025 CN1381278A (en) | 2002-05-20 | 2002-05-20 | Adsorbable internal fixing material for bone fracture and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02113025 CN1381278A (en) | 2002-05-20 | 2002-05-20 | Adsorbable internal fixing material for bone fracture and its preparing process |
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| CN1381278A true CN1381278A (en) | 2002-11-27 |
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| CN 02113025 Pending CN1381278A (en) | 2002-05-20 | 2002-05-20 | Adsorbable internal fixing material for bone fracture and its preparing process |
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Cited By (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100427283C (en) * | 2004-10-09 | 2008-10-22 | 武汉理工大学 | Directly heating, pressing and forming method for polylactic acid and hydroxy apatite composite material |
| CN101973125A (en) * | 2010-10-22 | 2011-02-16 | 中国科学院长春应用化学研究所 | Mould and method for manufacturing fracture internal fixation member |
| CN101991881A (en) * | 2010-11-24 | 2011-03-30 | 天津理工大学 | Controllable degradable internal fixation composite material and preparation method and application thereof |
| CN102085397A (en) * | 2011-01-19 | 2011-06-08 | 浙江普洛家园生物医学材料有限公司 | Absorbable implant material in bone and preparation method thereof |
| CN102266593A (en) * | 2011-07-27 | 2011-12-07 | 长春圣博玛生物材料有限公司 | Absorbable internal fracture fixing piece |
| CN102490308A (en) * | 2011-12-26 | 2012-06-13 | 华东理工大学 | Preparation method of absorbent composite internal fixator |
| CN102504508A (en) * | 2011-11-23 | 2012-06-20 | 天津理工大学 | Preparation method of magnesium-hydroxyapatite/polylactic acid composite molding material |
| CN102935248A (en) * | 2012-10-19 | 2013-02-20 | 东华大学 | PLA absorbable bone screw with PBC as toughening agent, and preparation method thereof |
| CN104436321A (en) * | 2014-12-25 | 2015-03-25 | 长春圣博玛生物材料有限公司 | Anchorage nail and preparation method thereof |
| CN105213005A (en) * | 2015-10-23 | 2016-01-06 | 成都市南丁医用材料有限公司 | Medical absorbable internal fixtion rivet |
| WO2016206180A1 (en) * | 2015-06-24 | 2016-12-29 | 东莞天天向上医疗科技有限公司 | Bioresorbable bone repair material and application and manufacturing method thereof |
| CN107296986A (en) * | 2016-04-14 | 2017-10-27 | 医盟生技股份有限公司 | The Bioabsorbable nail that can develop under x light |
| CN109666274A (en) * | 2018-12-27 | 2019-04-23 | 广州云瑞信息科技有限公司 | A kind of high-intensity absorbable bone fracture internal fixation material and preparation method thereof |
| CN109968572A (en) * | 2019-03-28 | 2019-07-05 | 山东大学齐鲁医院 | A kind of molding machine and method of the polylactic acid bone plate for cervical posterior approach |
| CN110639067A (en) * | 2019-10-16 | 2020-01-03 | 四川大学 | Composite material for processing miniature bone retention nail and preparation method thereof |
| CN110962318A (en) * | 2019-12-26 | 2020-04-07 | 扬州大学 | Preparation method of 3D-printed polylactic acid/nano-hydroxyapatite composite bone nail |
| CN111359025A (en) * | 2020-04-15 | 2020-07-03 | 花沐医疗科技(上海)有限公司 | Orderly-absorbed composite absorbable interface screw system with sheath and preparation method thereof |
| CN111494724A (en) * | 2020-05-28 | 2020-08-07 | 花沐医疗科技(上海)有限公司 | Composite absorbable interface screw and preparation method thereof |
| CN111643736A (en) * | 2020-05-28 | 2020-09-11 | 北京市春立正达医疗器械股份有限公司 | Composite material for interface screw and preparation method thereof |
-
2002
- 2002-05-20 CN CN 02113025 patent/CN1381278A/en active Pending
Cited By (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100427283C (en) * | 2004-10-09 | 2008-10-22 | 武汉理工大学 | Directly heating, pressing and forming method for polylactic acid and hydroxy apatite composite material |
| CN101973125A (en) * | 2010-10-22 | 2011-02-16 | 中国科学院长春应用化学研究所 | Mould and method for manufacturing fracture internal fixation member |
| CN101973125B (en) * | 2010-10-22 | 2012-12-12 | 中国科学院长春应用化学研究所 | Mould and method for manufacturing fracture internal fixation member |
| CN101991881A (en) * | 2010-11-24 | 2011-03-30 | 天津理工大学 | Controllable degradable internal fixation composite material and preparation method and application thereof |
| CN101991881B (en) * | 2010-11-24 | 2013-07-31 | 天津理工大学 | Controllablely degradable internal fixation composite material and preparation method and application thereof |
| CN102085397A (en) * | 2011-01-19 | 2011-06-08 | 浙江普洛家园生物医学材料有限公司 | Absorbable implant material in bone and preparation method thereof |
| CN102266593A (en) * | 2011-07-27 | 2011-12-07 | 长春圣博玛生物材料有限公司 | Absorbable internal fracture fixing piece |
| CN102504508A (en) * | 2011-11-23 | 2012-06-20 | 天津理工大学 | Preparation method of magnesium-hydroxyapatite/polylactic acid composite molding material |
| CN102490308A (en) * | 2011-12-26 | 2012-06-13 | 华东理工大学 | Preparation method of absorbent composite internal fixator |
| CN102935248A (en) * | 2012-10-19 | 2013-02-20 | 东华大学 | PLA absorbable bone screw with PBC as toughening agent, and preparation method thereof |
| CN104436321A (en) * | 2014-12-25 | 2015-03-25 | 长春圣博玛生物材料有限公司 | Anchorage nail and preparation method thereof |
| WO2016206180A1 (en) * | 2015-06-24 | 2016-12-29 | 东莞天天向上医疗科技有限公司 | Bioresorbable bone repair material and application and manufacturing method thereof |
| CN105213005A (en) * | 2015-10-23 | 2016-01-06 | 成都市南丁医用材料有限公司 | Medical absorbable internal fixtion rivet |
| CN107296986A (en) * | 2016-04-14 | 2017-10-27 | 医盟生技股份有限公司 | The Bioabsorbable nail that can develop under x light |
| CN109666274A (en) * | 2018-12-27 | 2019-04-23 | 广州云瑞信息科技有限公司 | A kind of high-intensity absorbable bone fracture internal fixation material and preparation method thereof |
| CN109968572A (en) * | 2019-03-28 | 2019-07-05 | 山东大学齐鲁医院 | A kind of molding machine and method of the polylactic acid bone plate for cervical posterior approach |
| CN109968572B (en) * | 2019-03-28 | 2022-03-25 | 山东大学齐鲁医院 | Molding device and method of polylactic acid bone fracture plate for posterior cervical vertebra surgery |
| CN110639067A (en) * | 2019-10-16 | 2020-01-03 | 四川大学 | Composite material for processing miniature bone retention nail and preparation method thereof |
| CN110962318A (en) * | 2019-12-26 | 2020-04-07 | 扬州大学 | Preparation method of 3D-printed polylactic acid/nano-hydroxyapatite composite bone nail |
| CN111359025A (en) * | 2020-04-15 | 2020-07-03 | 花沐医疗科技(上海)有限公司 | Orderly-absorbed composite absorbable interface screw system with sheath and preparation method thereof |
| CN111359025B (en) * | 2020-04-15 | 2022-03-15 | 花沐医疗科技(上海)有限公司 | Orderly-absorbed composite absorbable interface screw system with sheath and preparation method thereof |
| CN111494724A (en) * | 2020-05-28 | 2020-08-07 | 花沐医疗科技(上海)有限公司 | Composite absorbable interface screw and preparation method thereof |
| CN111643736A (en) * | 2020-05-28 | 2020-09-11 | 北京市春立正达医疗器械股份有限公司 | Composite material for interface screw and preparation method thereof |
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