CN1743486A - Alloy as magnesium element as matrix and its use as bone-fracture internal fixer - Google Patents
Alloy as magnesium element as matrix and its use as bone-fracture internal fixer Download PDFInfo
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- CN1743486A CN1743486A CN 200410054145 CN200410054145A CN1743486A CN 1743486 A CN1743486 A CN 1743486A CN 200410054145 CN200410054145 CN 200410054145 CN 200410054145 A CN200410054145 A CN 200410054145A CN 1743486 A CN1743486 A CN 1743486A
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Abstract
This invention discloses an alloy with Mg element as the matrix and the use as a fixer for fractures. Content of the composition and weight percentage is: Mg: 90-99.7%, other metals: 0.3~10%, which can be the fixer for fractures since it can provide suitable starting strength and degradation speed matched to knitting.
Description
Technical field
The present invention relates to the alloy that a kind of magnesium elements is a matrix, and this alloy is as the application of bone fracture internal fixing device.
Technical background
Said fracture among the present invention (fracture of bone) is TF normally.The regenerative power of bone is very strong, through the TF after well resetting, generally can heal fully in 3-4 month.Bone is outer, in the inner membrance osteoblast hyperplasia and produce the basis that newborn sclerotin is union of fracture.Fracture is after hemotoncus formation, fibering and osseous callus form and the process of poroma reconstruction and healing fully makes bone recover normal on 26S Proteasome Structure and Function.
Biomechanics Research to osteogenesis and knitting shows that the various stress that bones bears have determined the morphological structure of bone to a certain extent, has also determined the arrangement architecture of bones.Under fracture situation, the growth of osseous tissue and the reparation of bone must have stress to realize.
Force analysis to bone shows, the stress that the normal circumstances sending down the fishbone is born comprises that self heavy burden, muscular contraction force and outside atmosphere are the negative Gs that is added to human body, and they can be divided into pressure, tension force, torsion, shearing force and bending force at the effect on bone.Therefore, clinically, very high to the mechanical property requirements of bone fracture internal fixation material.
In a word, perfectly bone fracture internal fixing device should have following 2 mechanical functions at least:
1. enough initial physical strengths are provided, can bear the stress that to bear by osseous tissue at the fracture initial stage;
2. the intensity of internal fixation device can progressively reduce, and makes fracture site can be subjected to stress stimulation in agglutination, promotes the osseous tissue growth.
Traditional metal internal fixation device (stainless steel, titanium alloy etc.) is aspect the treatment fracture, and is clinical widely-used.It is advantageous that intensity height, moulding convenience, be easy to preservation etc., but also have significant defective: the mechanical consistency of (1) metal inside-fixture is poor, and promptly the mechanical consistency of metallic substance and osseous tissue does not match, and causes stress distribution inhomogeneous.Because stress shielding produces osteoporosis, bone resorption or osteanabrosis, delays initial stage knitting process, influences the poroma plastotype, the secondary fracture easily takes place.(2) histocompatibility of metal inside-fixture is poor, and mainly due to corrosion of metal, the metal ion of release can make body produce untoward reactions such as anaphylaxis, aseptic inflammation.(3) need second operation to take out inside-fixture.
The advantage that can absorb inside-fixture is that with the prolongation of the time of implantation, material is constantly degraded, and intensity reduces gradually, and stress is transferred on the bone gradually.Thereby reduce or eliminate stress fully occlusion effect and corresponding osteoporosis, do not need the most important thing is second operation, alleviate patient economically, the burden of physiology and psychology.
But owing to can absorb macromolecular material is that the present physical strength of internal fixation material of matrix is not enough, and range of application is also very limited, can only be used for the not high cortex bone of mechanical property requirements and fix; In addition, foreign body reaction is big, the material degraded mode in vivo of simple degradable polyester class is a bulk degradation, promptly, degrade simultaneously from material surface to material internal,, hastening phenomenon occurs thereby degraded in inside because inner degraded product can't spread, and degraded product can produce biological respinses such as inflammation in the part, is unfavorable for the later stage healing of osseous tissue.In addition, but traditional bio-absorbable internal fixation device strength property and speed of fracture union are inharmonious.
Summary of the invention
The technical issues that need to address of the present invention are to disclose alloy that a kind of magnesium elements is a matrix and as the application of bone fracture internal fixing device, to overcome the above-mentioned defective that prior art exists, satisfy the needs of medical field.
The contriver thinks that magnesium is metal the lightest in the practicality, also is the most active metal, can be separated the matter corrosion by the power and water in the body fluid.
The contriver finds simultaneously, is that the alloy of matrix can absorb in vivo with magnesium, and absorbed magnesium elements, has no side effect in vivo.Magnesium elements is the activator that surpasses 300 kinds of human body ferment, influences the metabolic function that body weight for humans is wanted, if there is not magnesium elements, cell just can not be metabolic, the especially metabolism of ATP (Adenosine Triphosphate).The generation of ATP is mainly by (1) the sugar decomposition effect on biochemical; (2) Ke Liebai circulation (Klebs Circulation); (3) three kinds of cellular biochemical reactions of electron transport chain, these biochemical reactions are all relevant with magnesium elements.Therefore, can not had side effects by the magnesium of bio-absorbable to human body.The magnesium elements that has added a small amount of other metals is the alloy of matrix, can have good bending resistance, tension, shear strength, can be used for preparing bone fracture internal fixing device, and adopts in the general method method for implantation human body of medical field.
The said magnesium elements of the present invention is that the component and the weight percent content of the alloy of matrix is:
Magnesium elements 90%-99.7%, other metallic elements 0.3～10%.
Said other metallic elements are selected from a kind of among Al, Zn, Ca or the Li or its more than one;
The adding of other metallic elements is for the bending strength that improves alloy, yield strength;
The material of said components can be used for preparing bone fracture internal fixing device, comprises Steel Plate For Fixation Of Fracture, screw, intramedullary nail or pinning etc.
The field of metallurgy known method is adopted in the moulding of magnesium alloy, is prepared as degeneration methods and casting, is broadly divided into:
1) gravity casting (Gravity Die casting);
2) low-pressure casting (Low pressure die casting);
3) semi-solid state die casting (Thixcasting);
4) fritting injection moulding (Thixomolding);
5) die casting (High pressure die casting).
Bone fracture internal fixing device of the present invention preferably adopts gamma ray sterilization before in implant into body.
Technique effect:
The present invention has tangible advantage:
Have moderate initial intensity, the intensity of stainless steel or titanium alloy internal fixation device is very high, well beyond the demand of healthy dense bone; The polylactic acid-based internal fixation device that intensity is the highest, its intensity still is lower than the intensity of healthy dense bone, has limited its range of application.The bone fracture internal fixing device that the present invention describes, intensity and have bigger regulation range between stainless steel and polymkeric substance.
The degradation speed that is complementary with knitting can be provided.Stainless steel or titanium alloy internal fixation device are after implantation, and intensity does not have to change substantially, therefore stress shielding can occur; Polylactic acid-based internal fixation device, its intensity are decayed very fast after implantation, also not healing fully, and its intensity disappears, and is not suitable for being applied to the reparation of load-bearing bone.
Embodiment
Embodiment 1
The moulding of magnesium alloy fritting injection moulding
(Mg: Al=97/3/wt) lathe into the fines shape, raw material quantitatively enters screw rod by feeding cylinder, and the Heating Zone Temperature of injector is controlled between 550-650 degree centigrade with magnesium ingot, rotating extruding by screw rod advances, make it become the fritting state, inject die cavity, cooling and shaping then at a high speed.By designing different moulds, can obtain different products, such as, Steel Plate For Fixation Of Fracture, screw, intramedullary nail, pinning etc.
Embodiment 2
The moulding of magnesium alloy fritting injection moulding
With magnesium ingot (Mg: Al=97/3wt) under 100-400 degree centigrade (being preferably in 200-300 degree centigrade), be squeezed into the solid bar of magnesium alloy, use the way of mechanical workout again, be processed into, internal fixation material such as intramedullary nail, pinning.
Embodiment 3-17
The magnesium alloy deformation legal system is equipped with the solid bar of heterogeneity
Select the magnesium ingot (proportioning such as 2-16) in the table 1 for use, processing conditions is with embodiment 2.
The component list of table 1 magnesium ingot
| Magnesium | Aluminium | Zinc | Calcium | Lithium | |
| Magnesium ingot 1 | 97 | 3 | 0 | 0 | 0 |
| Magnesium ingot 2 | 97 | 0 | 3 | 0 | 0 |
| Magnesium ingot 3 | 94 | 0 | 0 | 6 | 0 |
| Magnesium ingot 4 | 90 | 0 | 0 | 0 | 10 |
| Magnesium ingot 5 | 98 | 1 | 1 | 0 | 0 |
| Magnesium ingot 6 | 98 | 1 | 0 | 1 | 0 |
| Magnesium ingot 7 | 98 | 1 | 0 | 0 | 1 |
| Magnesium ingot 8 | 98 | 0 | 1 | 1 | 0 |
| Magnesium ingot 9 | 98 | 0 | 1 | 0 | 1 |
| Magnesium ingot 10 | 98 | 0 | 0 | 1 | 1 |
| Magnesium ingot 11 | 96 | 1 | 1 | 1 | 1 |
| Magnesium ingot 12 | 99.7 | 0 | 0.1 | 0.1 | 0.1 |
| Magnesium ingot 13 | 99.7 | 0.1 | 0 | 0.1 | 0.1 |
| Magnesium ingot 14 | 99.7 | 0.1 | 0.1 | 0 | 0.1 |
| Magnesium ingot 15 | 99.7 | 0.1 | 0.1 | 0.1 | 0 |
| Magnesium ingot 16 | 90 | 1.5 | 1.5 | 1 | 4.5 |
| Each composition range | 90-99.7 | 0-3 | 0-3 | 0-6 | 0-10 |
Embodiment 18-33
Magnesium alloy fritting injection moulding prepares the magnesium alloy of heterogeneity, selects the magnesium ingot (proportioning such as 2-16) in the table 1 for use, and preparation becomes screw, and processing conditions is with embodiment 1.
Embodiment 34
The sterilization of magnesium alloy implanting device and packing
Magnesium alloy is active material, and is very responsive to water, oxygen etc., therefore, common high hot high humidity or go back the oxidative ethane sterilising method, inapplicable to the magnesium alloy implanting device, but can adopt γShe Xianmiejun (preferably vacuum condition (pressure is less than 10-2Pa)).
Embodiment 35
The mensuration of magnesium alloy materials corrosion speed
With the diameter of embodiment 2 is that the magnesium alloy bone broach of 4.2mm is weighed, and be submerged in the phosphate buffered saline buffer of 37 degrees centigrade of pH values 7.4, regularly take out intramedullary pin and weigh, observe the weight loss of magnesium alloy, in the time of 6 months, the weight loss of magnesium alloy bone broach is at 30-60%.
Embodiment 36
The right back Fracture of femur treatment of dog
Cut under the blunt peeling of skin from the femur lateral margin in the right hind outside, avoid muscle, expose knochenbruch, the hole is squeezed into and got out to the magnesium alloy bone intramedullary needle of embodiment 2 from the proximal femoral knochenbruch, cut off the nail that gets out by big hole, make the intramedullary pin moderate length.Bone marrow nail is squeezed into the far-end knochenbruch with knochenbruch is involutory.For preventing the rotation of bone, add the magnesium alloy staple at the near-end and the far-end of bone intramedullary needle, add an amount of penicillin preventing infection, sew up muscle bundle sarolemma and skin with absorbable suture.Postoperative a year and a half check, magnesium alloy marrow nail disappears, and replaces healthy osseous tissue.
Claims (3)
1. the alloy that magnesium elements is a matrix is characterized in that, component and weight percent content are: magnesium elements 90%-99.7%, other metallic elements 0.3～10%;
Said other metallic elements are selected from a kind of among Al, Zn, Ca or the Li or its more than one.
2. the described magnesium elements of claim 1 is the application of the alloy of matrix, it is characterized in that, is used to prepare bone fracture internal fixing device.
3. application according to claim 2 is characterized in that said bone fracture internal fixing device comprises Steel Plate For Fixation Of Fracture, screw, intramedullary nail or pinning.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410054145 CN1743486A (en) | 2004-08-31 | 2004-08-31 | Alloy as magnesium element as matrix and its use as bone-fracture internal fixer |
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|---|---|---|---|
| CN 200410054145 CN1743486A (en) | 2004-08-31 | 2004-08-31 | Alloy as magnesium element as matrix and its use as bone-fracture internal fixer |
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| CN100368028C (en) * | 2005-12-22 | 2008-02-13 | 上海交通大学 | Bioabsorbable Mg-Zn Binary Magnesium Alloy Materials |
| WO2007125532A3 (en) * | 2006-04-28 | 2008-11-06 | Biomagnesium Systems Ltd | Biodegradable magnesium alloys and uses thereof |
| JP2010503509A (en) * | 2006-09-22 | 2010-02-04 | ユー アンド アイ コーポレーション | Implant containing biodegradable metal and method for producing the same |
| CN101015711B (en) * | 2007-02-07 | 2010-05-19 | 北京大学 | A kind of body fluid degradable medical implant and its preparation method |
| CN101690676B (en) * | 2009-10-26 | 2011-03-23 | 上海交通大学 | Absorbable metal intramedullary nail and preparation method thereof |
| CN101085377B (en) * | 2007-06-11 | 2011-05-04 | 沈阳工业大学 | Process for forming magnesium alloy ultra-fine thin-wall tube used for degradable blood vessel bracket |
| CN102100579A (en) * | 2011-04-01 | 2011-06-22 | 苏州奥芮济医疗科技有限公司 | In vivo degradable and absorbable metal encirclement device for bone fracture internal fixation |
| CN102392163A (en) * | 2011-11-07 | 2012-03-28 | 山东科技大学 | Degradable high-toughness corrosion-resistant medical Mg-Li-Ca alloy |
| CN102392164A (en) * | 2011-11-07 | 2012-03-28 | 山东科技大学 | Degradable high-toughness corrosion-resistant medical Mg-Li-Ca-Y alloy |
| CN102057068B (en) * | 2008-06-06 | 2012-08-29 | 斯恩蒂斯有限公司 | Resorbable magnesium alloy |
| CN102676894A (en) * | 2012-01-15 | 2012-09-19 | 河南科技大学 | Magnesium-based microcrystal alloy strip material and preparation method thereof |
| US20140271334A1 (en) * | 2013-03-14 | 2014-09-18 | Korea Institute Of Science And Technology | Biodegradable mg based alloy and implant |
| CN104755644A (en) * | 2012-08-31 | 2015-07-01 | 新特斯有限责任公司 | Ultrapure magnesium alloy with adjustable degradation rate |
| US9593397B2 (en) | 2013-03-14 | 2017-03-14 | DePuy Synthes Products, Inc. | Magnesium alloy with adjustable degradation rate |
| KR20190051286A (en) * | 2017-11-06 | 2019-05-15 | (주) 장원테크 | Method for manufacturng magnesium alloy having eccellent thermal dissipation properties |
| US10344365B2 (en) | 2012-06-26 | 2019-07-09 | Biotronik Ag | Magnesium-zinc-calcium alloy and method for producing implants containing the same |
| US10358709B2 (en) | 2012-06-26 | 2019-07-23 | Biotronik Ag | Magnesium-zinc-calcium alloy, method for production thereof, and use thereof |
| EP3561095A4 (en) * | 2016-12-22 | 2019-10-30 | Posco | MAGNESIUM ALLOY SHEET AND METHOD FOR MANUFACTURING THE SAME |
| US10478529B2 (en) | 2013-03-14 | 2019-11-19 | DePuy Synthes Products, Inc. | Magnesium alloy with adjustable degradation rate |
| CN111279004A (en) * | 2017-08-30 | 2020-06-12 | M.A.医疗联盟股份有限公司 | Metal alloys and medical devices containing the same |
| US10895000B2 (en) | 2012-06-26 | 2021-01-19 | Biotronik Ag | Magnesium alloy, method for the production thereof and use thereof |
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| CN100368028C (en) * | 2005-12-22 | 2008-02-13 | 上海交通大学 | Bioabsorbable Mg-Zn Binary Magnesium Alloy Materials |
| WO2007125532A3 (en) * | 2006-04-28 | 2008-11-06 | Biomagnesium Systems Ltd | Biodegradable magnesium alloys and uses thereof |
| JP2010503509A (en) * | 2006-09-22 | 2010-02-04 | ユー アンド アイ コーポレーション | Implant containing biodegradable metal and method for producing the same |
| US20100075162A1 (en) * | 2006-09-22 | 2010-03-25 | Seok-Jo Yang | Implants comprising biodegradable metals and method for manufacturing the same |
| EP2063816A4 (en) * | 2006-09-22 | 2011-07-20 | U & I Corp | Implants comprising biodegradable metals and method for manufacturing the same |
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| CN102057068B (en) * | 2008-06-06 | 2012-08-29 | 斯恩蒂斯有限公司 | Resorbable magnesium alloy |
| CN101690676B (en) * | 2009-10-26 | 2011-03-23 | 上海交通大学 | Absorbable metal intramedullary nail and preparation method thereof |
| CN102100579A (en) * | 2011-04-01 | 2011-06-22 | 苏州奥芮济医疗科技有限公司 | In vivo degradable and absorbable metal encirclement device for bone fracture internal fixation |
| CN102392164A (en) * | 2011-11-07 | 2012-03-28 | 山东科技大学 | Degradable high-toughness corrosion-resistant medical Mg-Li-Ca-Y alloy |
| CN102392163A (en) * | 2011-11-07 | 2012-03-28 | 山东科技大学 | Degradable high-toughness corrosion-resistant medical Mg-Li-Ca alloy |
| CN102676894A (en) * | 2012-01-15 | 2012-09-19 | 河南科技大学 | Magnesium-based microcrystal alloy strip material and preparation method thereof |
| CN102676894B (en) * | 2012-01-15 | 2014-09-17 | 河南科技大学 | Magnesium-based microcrystal alloy strip material and preparation method thereof |
| US10344365B2 (en) | 2012-06-26 | 2019-07-09 | Biotronik Ag | Magnesium-zinc-calcium alloy and method for producing implants containing the same |
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| US10196715B2 (en) | 2013-03-14 | 2019-02-05 | DePuy Synthes Products, Inc. | Magnesium alloy with adjustable degradation rate |
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| US9593397B2 (en) | 2013-03-14 | 2017-03-14 | DePuy Synthes Products, Inc. | Magnesium alloy with adjustable degradation rate |
| US20140271334A1 (en) * | 2013-03-14 | 2014-09-18 | Korea Institute Of Science And Technology | Biodegradable mg based alloy and implant |
| EP3561095A4 (en) * | 2016-12-22 | 2019-10-30 | Posco | MAGNESIUM ALLOY SHEET AND METHOD FOR MANUFACTURING THE SAME |
| US11268178B2 (en) | 2016-12-22 | 2022-03-08 | Posco | Magnesium alloy sheet and method for manufacturing same |
| CN111279004A (en) * | 2017-08-30 | 2020-06-12 | M.A.医疗联盟股份有限公司 | Metal alloys and medical devices containing the same |
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