CN105765095A - 植入物、用于制造该植入物的方法及其应用 - Google Patents
植入物、用于制造该植入物的方法及其应用 Download PDFInfo
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- 239000007943 implant Substances 0.000 title claims abstract description 47
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 15
- 239000011701 zinc Substances 0.000 claims abstract description 43
- 239000011777 magnesium Substances 0.000 claims abstract description 42
- 229910045601 alloy Inorganic materials 0.000 claims abstract description 41
- 239000000956 alloy Substances 0.000 claims abstract description 41
- 229910052725 zinc Inorganic materials 0.000 claims abstract description 33
- 229910052749 magnesium Inorganic materials 0.000 claims abstract description 30
- 239000011575 calcium Substances 0.000 claims abstract description 25
- 229910052791 calcium Inorganic materials 0.000 claims abstract description 13
- 229910009378 Zn Ca Inorganic materials 0.000 claims abstract description 9
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims abstract description 6
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- JBQYATWDVHIOAR-UHFFFAOYSA-N tellanylidenegermanium Chemical compound [Te]=[Ge] JBQYATWDVHIOAR-UHFFFAOYSA-N 0.000 claims abstract description 5
- 238000000034 method Methods 0.000 claims description 16
- 238000003856 thermoforming Methods 0.000 claims description 8
- 239000011159 matrix material Substances 0.000 claims description 6
- 239000012535 impurity Substances 0.000 claims description 5
- 239000000463 material Substances 0.000 claims description 4
- 230000032683 aging Effects 0.000 claims description 3
- 239000000126 substance Substances 0.000 abstract description 7
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- 238000005260 corrosion Methods 0.000 description 6
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- 238000006065 biodegradation reaction Methods 0.000 description 2
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- 238000005242 forging Methods 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
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Abstract
本发明涉及一种植入物、一种用于制造该植入物的方法及其针对发育中的患者的应用,该植入物具有基于Mg?Zn?Ca的合金。为了满足在兼容性以及耐化学性和机械强度方面的最高要求而提出的是,合金具有0.1至0.6重量百分比的锌(Zn)和0.2至0.6重量百分比的钙(Ca)和作为其余物的镁(Mg)以及受制造限制而不可避免的、分别最多为0.01重量百分比且总地至多为0.1重量百分比的杂质,其中,Zn和Ca重量百分比的商小于等于1。
Description
技术领域
本发明涉及一种针对发育中的患者的具有基于Mg-Zn-Ca的合金的植入物。
背景技术
由现有技术公知有可生物降解的植入物(DE102009002709A1),该植入物的材料由镁合金制成。镁合金也被公知为基于Mg-Zn-Ca的合金,其主要合金元素具有相对人类的机体的生物相容性。由此,能够避免对这种植入物周围的区域的刺激现象。此外,主要合金元素的这种生物相容性在儿童和青少年医疗中也开辟了置入植入物,尤其用于骨接合术的钉的可能性,这是因为溶解性的主要合金元素能够被在发育中的人的机体吸收和利用。此外,公知的基于Mg-Zn-Ca的钉出于强度的原因而具有相对较高的Zn含量,然而,这却导致减弱了钉的耐腐蚀性。副合金元素、尤其是稀土,可以再次提高钉的耐腐蚀性,但是却减少了其生物相容性,以此,将如此构建的钉尤其应用在儿童和青少年医疗中是危险的。
发明内容
因此,本发明的任务提出的是,以如下方式改进开头所述类型的基于Mg-Zn-Ca的植入物,即,使该植入物具有高强度并且在其相对人类的机体,尤其是儿童或在发育中的患者的机体的生物相容性方面仍然满足最高要求。
本发明通过如下方式解决在植入物方面的任务,即,合金具有0.1至0.6重量百分比的锌(Zn)和0.2至0.6重量百分比的钙(Ca)和作为其余物的镁(Mg)以及受制造限制而不可避免的、分别最多为0.01重量百分比且总地至多为0.1重量百分比的杂质,其中,Zn和Ca重量百分比的商小于等于1。
如果合金具有0.1至0.6重量百分比的锌(Zn),那么可以首先通过这种降低了的Zu含量来试图提高植入物的耐腐蚀性。但是另一方面,可以通过降低了的Zn含量预期到减低了的固溶强化。本发明可以通过如下方式来减少这种由此降低了的强度的缺点,即,使合金具有0.2至0.6重量百分比的钙(Ca),其中,Zn和Ca的重量百分比的商小于等于1[((Zn的重量百分比)/(Ca的重量百分比))≤1]。业已被证实的是,借助在合金的成分中的该限制可以主要析出(Mg,Zn)2Ca相(金属间相)。可以有利地抑制其它金属间相的构成,如MgZn2的和Mg6Zn3Ca2,这一方面能够表现出在植入物的较低的降解速度方面的优点。附加地,在根据本发明的合金中,(Mg,Zn)2Ca颗粒作为针对位错的障碍起作用,也就是说,它也引起了颗粒强化,这就有助于合金的强度的显著提升。但是,金属间的(Mg,Zn)2Ca析出也能够以有利的方式妨碍晶粒生长,这就能够显著改善植入物的强度和延展性。另外由于该(Mg,Zn)2Ca相比本来就相对不惰性的Mg基体更不惰性,所以“刺入”晶界的(Mg,Zn)2Ca相不作为阴极位置起作用并且随后不干扰均匀的腐蚀侵蚀。通过后者也避免了导致构成植入物的局部稳定性问题进而导致断裂部的、特别不利的点状腐蚀。因此,根据本发明的医用的植入物还可以提供经由其生物降解而均匀地减少机械强度,以便因此满足力求的在机体上的疗法或使用。因此,这样的植入物可以特别适用于骨接合术。由于在腐蚀和机械负荷方面的相对较高的稳定性或强度,使用附加的合金元素,例如稀土可以成为多余的。因此当植入物除了合金元素Zn、Ca之外作为其余物具有镁(Mg)以及受制造限制而不可避免的、分别最多为0.01重量百分比且总地至多为0.1重量百分比的杂质时就是足够的。因此,根据本发明的植入物实际上仅由生物相容的元素构成。因此,鉴于上述优点,该植入物可以特别适用于在发育中的患者。
一般性提及的是,用于骨接合术的植入物可以是克氏针、赫伯特螺钉,髓钉或类似物。优选的是,植入物是弹性稳定髓内钉(ESIN)。
合金可以通过如下方式满足在腐蚀性和机械受载能力方面的稳定性和强度的特别高的要求,即,该合金在其Mg基体中就金属间相而言主要(也就是大于50%地)含有(Mg,Zn)2Ca析出相。
上述的当合金在其Mg基体中仅含有(Mg,Zn)2Ca析出相时可以被进一步改善。
此外,本发明还提出了如下任务,即,简化用于制造植入物的方法,并且尽管如此仍然可再现地提供相对较高的耐化学性和机械强度。此外,该方法还应当能够相对低成本地来执行。
本发明通过如下方式解决了在用于制造针对发育中的患者的植入物的方法方面的任务,即,为了构造出(Mg,Zn)2Ca析出相而将该植入物的合金保持在200至400摄氏度范围内的温度上。
如果将用于构造出(Mg,Zn)2Ca析出相的植入物的合金保持在200至400摄氏度范围内的温度上,那么可以有针对性地影响(Mg,Zn)2Ca析出相的生长,从而形成特别细晶的(Mg,Zn)2Ca析出相。因此,可以以在方法技术上能简单处理的且低成本的方式可再现地以高的机械强度来制造医用的植入物。此外,根据本发明的方法也可以提供在Mg基体中均匀地分布的(Mg,Zn)2Ca析出相,以便确保在植入物上的均匀的生物降解。于是根据温度处理的持续时间而定地,可以满足力求的疗法或在机体上的使用地设计合金的机械强度和耐化学性。这尤其是在用于骨接合术的医用的植入物中,特别是也在儿童和青少年医疗中可以是有利的,植入物例如是克氏针、赫伯特螺钉,弹性稳定髓内钉(ESIN)或类似物。通常要注意的是,该温度处理可以在极其不同的用于制造植入物的方法步骤中进行。例如,在坯料热成型之前、在热成型(例如通过挤压、锻造、轧制或类似热成型)时和/或在热处理(例如在退火、热时效或类似热处理)时。因此,根据本发明的措施是特别易于处理地设置的并且显著简化了方法。
如果合金被保持在200至275摄氏度范围内的温度上,那么就可以在该部分范围内进一步提高(Mg,Zn)2Ca析出相的构成。
如已经提及地,当合金在热成型之前被保持在该温度上时可以促进合金优选构造出(Mg,Zn)2Ca析出相。
优选地,在热成型期间,或在热成型之前和其期间,合金可以保持在该温度上用以构造出(Mg,Zn)2Ca析出相,以便将热处理与成型相结合,并且因此更快更经济地执行该方法。热成形能够被理解为挤压、锻造、轧制或类似热成形。例如,为此在其中一个温度中对植入物的坯料进行锻造可以是特别突出的,以便优化植入物的机械强度和耐化学性。在对植入物进行热成型之后可以使植入物经受最终加工,例如切削加工。
此外能够想到的是,通过如下方式优选获得(Mg,Zn)2Ca析出相,即,在热时效期间将合金保持在该温度上用以构造出(Mg,Zn)2Ca析出相。
特别地,当基于Mg-Zn-Ca的合金具有0.1至0.6重量百分比的锌(Zn)、0.2至0.6重量百分比的钙(Ca)和作为其余物的镁(Mg)以及受制造限制而不可避免的、分别最多为0.01重量百分比且总地至多为0.1重量百分比的杂质,其中,Zn和Ca重量百分比的商小于等于1[((Zn的重量百分比)/(Ca的重量百分比))≤1]时,本发明在作为材料用于制造针对发育中的患者的、在骨接合术中使用的植入物的应用是突出的。
尤其地,材料的应用适用于克氏针、赫伯特螺钉,髓钉和/或弹性稳定髓内钉。
具体实施方式
为了记录所取得的效果,制备了具有基于Mg-Zn-Ca的不同的合金的钉作为医用的植入物。在表1中列举的所研究的合金的组成。
钉号 | 组成 |
1 | MgZn1,Ca0.25Mn0.15Y2 |
2 | MgZn5,Ca0.25Mn0.15 |
3 | MgZn0.4Ca0.4 |
表1:钉的一览表
表1的1号钉是在应用了稀土Y作为合金元素的情况下已公知的镁合金。同样由现有技术钉所公知的根据表1的2号钉舍弃了稀土作为合金元素,然而为了达到所期望的强度而需要锌的份额提高,这就减低了钉的耐化学性(耐腐蚀性)。在表1中在组成方面示例性地给出的3号钉具有根据本发明的镁合金。3号钉具有在Zn的所要求保护的0.1至0.6重量百分比范围内的0.4重量百分比的Zn、在Ca的所要求保护的0.2至0.6重量百分比范围内的0.4重量百分比的Ca。Zn和Ca的重量百分比的商(Zn的重量百分比除以Ca的重量百分比)为1,并且因此也如根据本发明所要求的那样小于等于1。该3号钉由经冷却的、经挤压的坯料以随后进行切削加工来制成。挤压在200至400℃的温度界限内进行。
所述的钉就其耐化学性和机械强度进行试验。为此,在拉伸试验中确定抗拉强度Rm、屈服极限Rp0.2和断裂延率A5。此外,在SBF(模拟体液)中测量了降解。所得到的测量值被归纳于表2中。
钉号 | Rp0.2[MPa] | Rm[MPa] | A5 | SBF[mm/年] |
1 | 150 | 250 | 20 | 0.5 |
2 | 210 | 295 | 18 | 4 |
3 | 200 | 250 | 22 | 0.25 |
表2:所试验的钉的测量结果
3号钉的相对于2号钉相对较低的锌含量如表2所获知地导致在机械强度方面没有缺点,而是由此十分特别地在至多0.25mm/年的降解的提高了的耐化学性方面获益。这本身比在其合金中不利地具有稀土的1号钉上所测量的降解要低。
因此,提供了一种稳定的可生物降解的植入物,其特别适用于儿童和青少年医疗或通常适用于在发育中的患者。这一点得到确保,这是因为没有使用稀土,因此,合金成分是具有生物相容性的,并且因此能够被在发育中的机体利用,然而附加地,仍然提供了高机械强度和耐化学性。
Claims (12)
1.一种针对发育中的患者的植入物,所述植入物具有基于Mg-Zn-Ca的合金,其特征在于,所述合金具有
0.1至0.6重量百分比的锌(Zn)和
0.2至0.6重量百分比的钙(Ca)
和作为其余物的镁(Mg)以及受制造限制而不可避免的、分别最多为0.01重量百分比且总地至多为0.1重量百分比的杂质,其中,Zn和Ca重量百分比的商小于等于1。
2.根据权利要求1所述的植入物,其特征在于,所述合金在所述合金的Mg基体中就金属间相而言主要含有(Mg,Zn)2Ca析出相。
3.根据权利要求2所述的植入物,其特征在于,所述合金在所述合金的Mg基体中仅含有(Mg,Zn)2Ca析出相。
4.根据权利要求1、2或3所述的植入物,其用于骨接合术。
5.一种用于制造根据权利要求1至4中任一项所述的针对发育中的患者的植入物的方法,在所述方法中,为了构造出(Mg,Zn)2Ca析出相而将所述植入物的合金保持在200至400摄氏度范围内的温度上。
6.根据权利要求5所述的方法,其特征在于,为了构造出(Mg,Zn)2Ca析出相而将所述合金保持在200至275摄氏度范围内的温度上。
7.根据权利要求5或6所述的方法,其特征在于,为了构造出(Mg,Zn)2Ca析出相,在热成型之前将所述合金保持在所述温度上。
8.根据权利要求5、6或7所述的方法,其特征在于,为了构造出(Mg,Zn)2Ca析出相,在热成型期间将所述合金保持在所述温度上。
9.根据权利要求5至8中任一项所述的方法,其特征在于,为了构造出(Mg,Zn)2Ca析出相,在热时效期间将所述合金保持在所述温度上。
10.用于制造植入物的根据权利要求5至9中任一项所述的方法,所述植入物用于骨接合术。
11.一种基于Mg-Zn-Ca的合金的应用,所述合金具有0.1至0.6重量百分比的锌(Zn)、0.2至0.6重量百分比的钙(Ca)和作为其余物的镁(Mg)以及受制造限制而不可避免的、分别最多为0.01重量百分比且总地至多为0.1重量百分比的杂质,其中,Zn和Ca重量百分比的商小于等于1,所述合金作为材料用于制造在骨接合术中使用的针对发育中的患者的植入物。
12.根据权利要求11所述的应用,其特征在于,所述植入物作为克氏针、赫伯特螺钉,髓钉和/或弹性稳定髓内钉使用。
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EP13187287.1 | 2013-10-03 | ||
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Publication number | Priority date | Publication date | Assignee | Title |
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CN110755177A (zh) * | 2019-10-25 | 2020-02-07 | 上海交通大学医学院附属第九人民医院 | 一种骨缺损植入物及构建方法、制备方法、计算机可读存储介质、设备 |
CN112899506A (zh) * | 2021-01-18 | 2021-06-04 | 陕西科技大学 | 一种Mg-Zn-Ca合金及其加工方法 |
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US20200384160A1 (en) * | 2018-02-20 | 2020-12-10 | Thixomat, Inc. | Improved magnesium alloy and process for making the same |
US10405889B2 (en) * | 2018-06-14 | 2019-09-10 | New Standard Device, LLC | Cold forged cutting tip for orthopedic wires and pins |
GB2576706A (en) | 2018-08-20 | 2020-03-04 | Bri Tech | Magnesium alloy based implant and method of preparing an implant |
US11969519B1 (en) | 2023-05-24 | 2024-04-30 | Bioretec Oy | Implant comprising magnesium alloy and a method for preparing thereof |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1792383A (zh) * | 2005-12-22 | 2006-06-28 | 上海交通大学 | 生物体内可吸收的Mg-Zn-Ca三元镁合金材料 |
EP1840235A1 (de) * | 2006-03-31 | 2007-10-03 | BIOTRONIK VI Patent AG | Magnesiumlegierung und dazugehöriges Herstellungsverfahren |
CN101629260A (zh) * | 2008-07-18 | 2010-01-20 | 中国科学院金属研究所 | 医用可吸收Mg-Zn-Mn-Ca镁合金 |
EP2511390A2 (en) * | 2009-12-07 | 2012-10-17 | U & I Corporation | Magnesium alloy |
WO2013052791A2 (en) * | 2011-10-06 | 2013-04-11 | University Of Pittsburgh-Of The Commonwealth System Of Higher Education | Biodegradable metal alloys |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PL2294236T3 (pl) * | 2008-06-06 | 2015-09-30 | Synthes Gmbh | Stop magnezu ulegający resorpcji |
DE102009002709A1 (de) | 2008-10-06 | 2010-04-08 | Biotronik Vi Patent Ag | Implantat und Verfahren zur Herstellung desselben |
US9677151B2 (en) | 2012-01-19 | 2017-06-13 | Eth Zuerich | Process and apparatus for vacuum distillation of high-purity magnesium |
WO2014001321A1 (en) | 2012-06-26 | 2014-01-03 | Biotronik Ag | Magnesium-zinc-calcium alloy, method for production thereof, and use thereof |
JP6502315B2 (ja) | 2013-03-14 | 2019-04-17 | デピュイ・シンセス・プロダクツ・インコーポレイテッド | 分解速度が調整可能なマグネシウム合金 |
-
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-
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- 2014-10-03 WO PCT/EP2014/071255 patent/WO2015049379A1/de active Application Filing
- 2014-10-03 US US15/026,966 patent/US9757174B2/en active Active
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- 2014-10-03 CA CA2925765A patent/CA2925765A1/en not_active Abandoned
- 2014-10-03 JP JP2016546169A patent/JP2016540128A/ja active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1792383A (zh) * | 2005-12-22 | 2006-06-28 | 上海交通大学 | 生物体内可吸收的Mg-Zn-Ca三元镁合金材料 |
EP1840235A1 (de) * | 2006-03-31 | 2007-10-03 | BIOTRONIK VI Patent AG | Magnesiumlegierung und dazugehöriges Herstellungsverfahren |
CN101629260A (zh) * | 2008-07-18 | 2010-01-20 | 中国科学院金属研究所 | 医用可吸收Mg-Zn-Mn-Ca镁合金 |
EP2511390A2 (en) * | 2009-12-07 | 2012-10-17 | U & I Corporation | Magnesium alloy |
WO2013052791A2 (en) * | 2011-10-06 | 2013-04-11 | University Of Pittsburgh-Of The Commonwealth System Of Higher Education | Biodegradable metal alloys |
Non-Patent Citations (2)
Title |
---|
欧阳春等: "Mg-Zn-Ca三元镁合金生物材料的腐蚀行为", 《中国有色金属学报》 * |
毛丽贺等: "锌对医用Mg-Ca-Zn合金组织及力学性能的影响", 《金属热处理》 * |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110755177A (zh) * | 2019-10-25 | 2020-02-07 | 上海交通大学医学院附属第九人民医院 | 一种骨缺损植入物及构建方法、制备方法、计算机可读存储介质、设备 |
CN112899506A (zh) * | 2021-01-18 | 2021-06-04 | 陕西科技大学 | 一种Mg-Zn-Ca合金及其加工方法 |
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