CN1568200A - 亲骨型植入物 - Google Patents

亲骨型植入物 Download PDF

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CN1568200A
CN1568200A CNA028202457A CN02820245A CN1568200A CN 1568200 A CN1568200 A CN 1568200A CN A028202457 A CNA028202457 A CN A028202457A CN 02820245 A CN02820245 A CN 02820245A CN 1568200 A CN1568200 A CN 1568200A
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implant
ray
titanium
hydroxylating
hydrophilic
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A·J·登策尔
J·P·辛普森
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Straumann Holding AG
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Abstract

本发明涉及一种具有粗糙的羟基化和亲水性表面的亲骨型植入物，它由钛或钛合金构成，并适于植入骨中，该植入物的特征在于，在羟基化状态下用高能紫外射线处理。

Description

亲骨型植入物
本发明涉及亲骨型植入物(osteophile Implante)，它用于***骨中并大大地改进骨的整合特性，本发明还涉及一种制备该植入物的方法。
***骨中的植入件如髋关节修复件或膝关节修复件或拧固在颌骨上的用于构成假牙的固定桩(Stift)是已知的。这类植入件优选用钛或钛基合金如钛/锆合金构成，其中还可含有铌、钽和其它与组织相容的金属添加物。这种植入物的主要特性是其骨整合时间，即直到骨物质以足够的强度和持久地与植入物表面相接合即整合所经过的时间。
植入物在骨中固定的牢固度可用机械测量来确定，即通过测量将其从其固定处拉脱或拧脱，使植入物表面和与其接合的骨物质之间脱开所需的力，如拉力、压力、剪力、扭矩来测定。这些测量方法是已知的，并描述于Brunski，Clinical Materials，Vol.10，1992，pp153-201中。测量已表明，具有光滑表面结构的钛-植入物不足以在骨中固定，但具有粗糙表面的植入物从抗拉强度看提供了明显改进的骨-植入物接合。
因此，按照EP 0 388576在第一步中通过喷砂使植入物表面产生宏观粗糙度，接着通过在酸浴中处理以叠置微观粗糙度。例如该植入物表面经喷砂粗糙化，并接着用腐蚀剂如氢氟酸或氢氯酸/硫酸混合物处理。如此提供的具有一定粗糙度的表面再经水和溶剂洗涤及清毒处理。
例如用钛或钛基合金制成的表面的化学状态是复杂的。那是由于钛金属的表面在空气和水平会自行氧化，然后在表面上、即在最外原子层上与水发生反应，以形成羟基。这种含羟基的表面在文献中称为“羟基化”表面。参看H.P.Boehem，Acidic and Basic Propertiesof Hydroxylted Metal Oxide Surfaces，Discussions FaradaySociety，Vol.52，1971，pp.264-275。但是仅当羟基化的表面处于“亲水”状态、即未被如空气中存在的易挥发的烃和其它化合物例如二氧化硫或一氧化氮所覆盖时，才能发挥其全部作用。在制备方法的每一步中，例如在用有机溶剂如甲醇或丙酮处理植入物的净化过程中，其它杂质也可达到表面上。羟基化和亲水性的表面，例如钛或钛合金的表面具有生物活性特征或可看作是生物活性的。与相同的羟基化的但非亲水性的表面相比，羟基化的和亲水性的植入物表面会快得多地随骨物质生长，并很强地接合在一起。羟基化的并同时又亲水性的植入物表面的制备在WO 0044305(PCT/EP00/00619)中已有描述。
无污染的羟基化表面具有高的表面能，它导致在不干净空气中存在的易挥发的烃和其它杂质被快速吸附。起初例如该被吸附的烃在羟基化表面上形成单分子层，这时失去了表面的亲水性。植入物在空气中暴露的时间越长，则污染层就越厚。由钛制成的清洁的羟基化表面是亲水的，并在用水湿润时的接触角小于50°，而沾污的羟基化表面的接触角大于70°，并认为是疏水性的。虽然当将这种表面密闭在包封中以防止此表面与有损植入物表面的亲水特性的化合物相接触时，可基本上保持羟基化的和亲水性的表面不改变，并且由此保持其生物活性不发生改变。但是就在植入前需使包封破裂时，就不能防止植入物表面与外部空气接触，并由此使植入物表面的亲水特性下降。因此需要如此制备和处理羟基化的和亲水性的植入物表面，使其在与外部大气空气接触时仍能在长的时间间隔内保持其亲水特性。
曾发现，当用高能的紫外射线(UV-射线)处理这种表面时，可使羟基化的但受污染的、即由杂质覆盖的疏水性的植入物表面得到亲水特性。令人意外的是，与例如通过酸腐蚀所得到的羟基化的和亲水性的植入物表面相比，经UV-射线处理所得的羟基化的和亲水性的表面更不易受外部空气杂质的覆盖影响。同样还发现，当亲水状态下的表面经高能紫外线处理时，可明显增加用酸腐蚀所得到的羟基化和亲水性的植入物表面的亲水特性的稳定性。这种处理的另一优点在于，可不需对植入物进行附加的消毒。
本发明在专利权利要求中加以定义。本发明特别涉及一种具有特别粗糙的羟基化和亲水性表面的亲骨型植入物，这种植入物优选由钛或钛合金制成，并适于植入骨中，其特征在于，该羟基化状态下的植入物经高能紫外射线处理。但也可考虑其它材料如其它金属和陶瓷。
术语“羟基化状态下的植入物”不但指以具有羟基化表面而制备的，其表面具有疏水特性的植入物，也指具有羟基化和亲水性表面的植入物。本发明的植入物具有明显高的抗失去亲水性的稳定性，并由此具有改进的骨整合特性。
本发明还涉及一种制备具有特别粗糙的、羟基化和亲水性表面的亲骨型植入物的方法，其中该植入物优选由钛或钛合金制成，并适用于植入骨中，其特征在于，该在羟基化状态下的植入物经高能紫外射线处理。
本发明的植入物优选由钛合金，优选由钛/锆合金制成，其还可含铌、钽或其它与组织相容的金属添加物。另一些材料也适用于本发明的范围。该植入物优选用作髋关节修复件或膝关节修复件或拧固在颌骨上的用于构成假牙的固定桩。这种植入物，其特性以及为此制备所用的材料是已知的，例如描述于J.Black，G.Hastings，Handbook ofBiomaterials Propeties，第135-200页，Verlag Chapman & Hall，London，1998。
例如牙齿植入物在骨中的结构和功能性固定通常是通过施加宏观粗糙度如螺纹或在表面中的凹坑和/或任选地附加微观粗糙度来达到的，该微观粗糙度或在附加的过程中通过等离子体技术施加，或在精制过程中通过化学腐蚀来施加。施加宏观粗糙度，如螺纹或表面中的凹坑和任选的附加微观粗糙度均是已知的。为实施本发明，即制备具有宏观粗糙度又附加叠置有微观粗糙度的植入物优选是按在EP0388576或在WO 0044305(PCT/EP00/00619)中所述的方法进行的。然后对由此所得的植入物可按本发明用高能紫外射线进行处理。
本发明的植入物表面的宏观粗糙度优选为5μm-100μm(总是指峰谷间)，特别是20μm-40μm，其叠置的微观粗糙度为0.5μm-20μm，特别是0.5μm-10μm，特别是约2μm。
此两个叠置的粗糙度可在两个相继的步骤中制备。例如该植入物表面的宏观粗糙度可通过用平均粒度为0.25-0.5mm的刚玉颗粒的喷砂产生，接着该微观粗糙度通过在80°-约110℃的温度下用HCl∶H2SO4∶H2O＝2∶1∶1的含水氢氯酸/硫酸混合物处理约5分钟来得到。此酸浴处理后，将该表面结构化的钛部件，或该植入物用纯水彻底洗至中性，任选地用醇、丙酮或其它有机溶剂或消毒剂处理。由此所得的植入物可经密封包装，任选地用伽玛射线进行消毒。如果在酸浴之后用纯水彻底洗涤植入物表面至中性，并在对亲水表面呈惰性的气氛中干燥及将该植入物保存在惰性气氛中，则以这种方法就可得到亲水性的植入物表面。在用醇、丙酮或其它有机溶剂或消毒剂中处理，并在热空气中干燥的情况下，得到疏水性的植入物表面。
用于洗涤的“纯”水优选是经多次蒸馏或经反渗析所制备的水，优选在惰性气氛即例如在低压下于氮气氛或惰性气氛中进行制备。此外，该纯水的电阻至少为2Mohm cm(电阻＞2Mohm cm)，有机碳的总含量最高为10ppb(≤10ppb)。
按本发明，该呈羟基化态的植入物经高能紫外射线处理。该高能紫外射线(UV-射线)使植入物表面变成亲水性，并去除存在于表面上的杂质。本发明可应用波长为150nm-300nm，优选170nm-260nm的UV-射线作为高能UV-射线，特别是用氧的吸收最大值范围内的UV射线，即波长约为184.9nm范围的UV-射线以及臭氧的吸收最大值范围内的UV射线，即波长约为253.7nm范围的UV-射线作为高能UV-射线。在该范围的波长有利于臭氧的同时形成和分解，并能断开高能化学键，如烯属碳-碳双键。在所述范围的波长可由市售的所谓氙辐射器产生。
因为射线的强度随着与UV-源的距离呈指数下降，所以使要处理的植入物表面离UV-源的距离小，例如在约1mm的范围是有利的。UV-照射的持续时间与沾污的种类和厚度有关，可由本专业技术人员很容易确定或最佳化。通常辐照持续的时间为1-15分钟。在按本发明处理亲水性(因此已经较为纯净)表面时，通比处理沾污的表面可得到更纯的产物。
为了分析用UV-射线处理过的植入物表面，利用XPS(X-射线激发的光电子光谱法)或俄歇电子光谱法(AES)是有利的。例如直接在酸腐蚀后形成的并经羟基化和是亲水性的植入物表面，在与该表面接触的水滴增大(Vordringen)时的水的湿润角＜50°，在再形成(zuriickbildenden)水滴情况下其水的湿润角＜20°，并具有明显的生物活性。这同样适于用UV-射线处理过的植入物表面，但在与外部空气接触时，其亲水特性按本发明可保持较长的时间。
以工业规模制备的钛和钛合金的表面对用于实验室和临床来说通常具有杂质，这些杂质主要由碳化合物和痕量的氮、钙、硫、磷和硅构成。这些杂质集中在最外的金属氧化物层中。本发明所制备的羟基化的和亲水性的植入物表面按光谱法如XPS或AES或其它已知的光谱法测定其含有最高为20原子％的碳。
在经UV-射线处理后，该所得的植入物优选保存在充有对植入物表面是惰性的气体的包封中。这种惰性气体，即不影响表面的亲水性或其生物活性的气体例如是氮、氧或稀有气体如氩。该包封优选是对气体和液体不可渗透的包封。有害于植入物表面的生物活性的化合物例如是已提到过的甲醇、乙醇、丙酮和类似的酮类以及大量其它的有机化合物或二氧化碳。
任选地，可在包封中部分或全部充有纯水，有时纯水中还可含有添加物，其中至少存在能保证粗糙的植入物表面保湿或湿润的水量。
合适的添加物例如是具有呈无机盐形式的相应阴离子的一价碱金属阳离子如Na+或K+，例如氯化钠、氯化钾、氯酸钠或氯酸钾、硝酸钠或硝酸钾、磷酸钠或磷酸钾或这些盐的混合物。同样也可加入具有可溶于水的无机盐形式的二价阳离子。合适的阳离子特别是呈氯化物形式的Mg2+、Ca2+、Sr2+和/或Mn2+或其混合物。合适的阴离子也可以是磷酸根阴离子和膦酸根阴离子，此时可理解为是与上述阳离子相组合的单正磷酸根阴离子和二正磷酸根阴离子、以及单正膦酸根阴离子和二正膦酸根阴离子。
已在体液中存在的，特别是以其生理浓度和在生理酸值(pH值)为4-8，优选酸值为6-8范围内存在的阳离子和阴离子是优选的。优选的阳离子为Na+、K+、Mg+2和Ca+2。优选的阴离子是Cl-。所述阳离子或阴离子的总量各宜为约50mEq/l-250mEq/l，优选约100mEq/l-200mEq/l，特别是约150mEq/l。这里，Eq/l意指(化学式-)当量重量或Eq/l相当于分子式单元的原子重量除以价态。mEq/l意指毫克当量重量/升。如果在包封中单独地或与所述一价阳离子组合地含有两价阳离子，特别是Mg+2、Ca+2、Sr+2和/或Mn+2，则所存在的两价阳离子的总量优选为1-20mEq/l。
气密性和液密性的包封优选是由玻璃、金属、合成聚合物或其它气密性和液密性的材料或由这些材料的组合构成的密封安瓿。该金属优选以薄金属箔形式存在，也可按照已知的方式将聚合物材料和金属箔以及玻璃相互组合成合适的包装。
但是，本发明的特别优点在于，如果该植入物在按本发明用UV-射线处理之后在一段合适的时间如1小时内就要植入，则就不需将植入物包装在上述的气密性和液密性的包装中。意外的是，正如一开始所指出的，按本发明处理过的植入物表面在这段时间内就是与大气空气接触也会保持其亲水特性基本上不变。适用的较紧凑的UV-设备现在可以得到，并且易于在医疗实际中安装。因此，只要将由上述的和本身已知方法制备的具有粗糙的疏水性表面的植入物以无尘包装就足够的。手术外科医生(牙外科医生)就在植入前按本发明在UV-设备中用UV-射线处理具有疏水表面的植入物，由此得到具有羟基化的亲水性表面的无微生物(消毒过的)的植入物。这种植入物表面的羟基化和亲水性状态并由此其生物活性可基本保持到植入操作。
本发明还涉及一种用于植入具有粗糙的羟基化和亲水性表面的植入物的方法，其中该植入物由钛或钛合金构成，并适于植入骨中，其特征在于，用高能紫外射线处理呈羟基化状态的植入物，并就在该处理之后植入骨中。下面以实施例说明本发明。
实施例1
制备直径为4mm，长度为10mm的呈螺杆形的常用牙齿植入物。按已知方法对圆柱形坯料进行车削和铣削以得到坯状体。该***骨中的表面按EP 0 388576提供以宏观粗糙度，其中采用平均粒度为0.25-5mm的颗粒进行喷砂。接着该称为宏观粗糙度的粗糙表面在95℃下经HCl∶H2SO4∶H2O＝2∶1∶1的含水氢氯酸/硫酸混合物处理5分钟，以使粗糙的植入物表面与较抛光的表面的比为3.6，它是在0.15M NaCl的含水电解质中以伏安法测定的(相应于0.1摩尔Na2SO4电解质中以阻抗测定法所得的比例是3.9)。由此所形成的植入物用纯水仔细洗至中性，接着在大气空气中于110℃下干燥，并无尘包装在玻璃安瓿中。如此制备多种同样的植入物。经4周后打开该安瓿。
a)一部分植入物未经变化地植入(对比例)。
b)另一部分植入物在Radium公司(Lampenwerk Wipperfürth，Deutschland)的氙-辐照器中用最大发射波长为172mm的UV-射线以距离为0.1mm于大气空气中处理。
实验a)[未经UV-处理]样品的湿润角超过70°(＞70°)，并且表面上的碳含量为20-40原子％。实验b)[经UV-处理]样品是完全可湿润的，即其湿润角为0°，表面的碳含量为8-13原子％。实验b)样品的贫碳状态在至少一天的时间期内可保持实际上无变化。
将实验a)和b)的植入物植入小猪的上颌骨中。在骨中的固定度由植入小猪的上颌骨中的螺栓的松脱扭矩来度量。所得结果列于表1中。
表1
 2周后的固定度*(Ncm)  3周后的固定度*(Ncm)  4周后的固定度*(Ncm)
实验  a)  20  58  80
实验  b)  55  85  110
*该固定度以单位为Ncm的松脱扭矩(Lsedrehmoment)(平均值)给出。

Claims (19)

1.由钛或钛合金构成的具有羟基化表面、优选具有粗糙的适于植入骨的表面的亲骨型植入物，其特征在于，该植入物是亲水的，即表面上基本不存在杂质。
2.由钛或钛合金构成的具有粗糙表面的亲骨型植入物，它通过包括直到植入有活性的表面-处理过程的生产和制备方法制备，其步骤如下：
(a)羟基化植入物的表面，和
(b)用紫外射线处理植入物表面以制备亲水性表面，特别是用以破坏和/或去除有机杂质。
3.权利要求1或2的植入物，其特征在于，该经处理的植入物表面的碳含量小于20原子％，特别是小于13原子％。
4.权利要求1或3之一的植入物，其特征在于，用UV-射线处理表面，以达到亲水性和去除表面的杂质。
5.权利要求1-4之一的植入物，其特征在于，它由钛合金，优选由钛/锆合金构成，任选地还可含有铌、钽或其它与组织相容的，特别是金属添加物。
6.权利要求1-5之一的植入物，其特征在于，该植入物是髋关节修复件或膝关节修复件或引入颌骨中用于构成假牙的固定桩。
7.权利要求1-6之一的植入物，其特征在于，该植入物表面具有宏观粗糙度，优选螺纹或表面上的凹坑，任选地还有叠置在宏观粗糙度上的微观粗糙度。
8.权利要求7的植入物，其特征在于，其宏观粗糙度为5-10μm(总是指峰谷间)，特别是20-40μm，其叠置的微观粗糙度为0.5-20μm，特别是0.5-10μm，特别是约2μm。
9.权利要求1-8之一的植入物，其特征在于，应用其波长为150-300nm，优选170-260nm的UV-射线，特别是应用波长为约184.9nm和约253.7nm的UV-射线。
10.权利要求1-9之一的植入物，其特征在于，其辐照持续时间为1-15分钟。
11.权利要求1-10之一的植入物，其特征在于，该植入物包装在充有对植入物表面是惰性的气体，优选氮、氧或稀有气体的、不渗透气体和液体的包封中。
12.权利要求11的植入物，其特征在于，该包封部分或全部充有纯水，任选地还含有添加物。
13.权利要求12的植入物，其特征在于，该水含呈无机盐形式的具有相应阴离子的碱金属阳离子，优选Na+或K+，优选为氯化钠、氯化钾、氯酸钠或氯酸钾、硝酸钠或硝酸钾、磷酸钠或磷酸钾或这些盐的混合物，或具有水可溶的无机盐形式的二价阳离子，优选Mg2+、Ca2+、Sr2+和/或Mn2+，优选是氯化物，或水可溶的磷酸盐和/或膦酸盐形式。
14.权利要求12或13的植入物，其特征在于，其阳离子和阴离子的总量各为50mEq/l-250mEq/l，优选100mEq/l-200mEq/l，优选约150mEq/l。
15.权利要求11-14之一的植入物，其特征在于，其气密性和液密性的包封是由玻璃、金属、合成聚合物或其它气密性和液密性的材料或由这些材料的组合构成的安瓿。
16.权利要求1-15之一的亲骨型植入物，其具有粗糙化的羟基化的和亲水的表面，该植入物由钛或钛合金构成，其特征在于，该羟基化态的植入物经高能紫外射线处理。
17.用于植入具有羟基化和亲水性的，优选具有粗糙的适于植入骨中的表面的亲骨型植入物的方法，其中该植入物由钛或钛合金构成，其特征在于，使该羟基化态的植入物经UV-射线处理，采用波长为150nm-300nm，优选170nm-260nm的UV-射线，特别是采用波长为约184.9nm和约253.7nm的UV-射线进行处理，紧接该处理后将该植入物植入骨中。
18.用于植入具有羟基化和亲水性的，优选具有粗糙的适于植入骨中的表面的亲骨型植入物的方法，其中该植入物由钛或钛合金构成，其特征在于，使该羟基化态的植入物经UV-射线处理，采用波长为150nm-300nm，优选170nm-260nm的UV-射线，特别是采用波长为约184.9nm和约253.7nm的UV-射线进行处理，如此达到的表面的亲水性状态通过合适的贮存加以保持，并在以后的时间点完成该植入物在骨中的植入。
19.由钛或钛合金构成的，优选具有适于植入的粗糙表面的亲骨型植入物作为牙科植入物的应用，其表面经羟基化，并通过UV-射线，特别是高能射线辐照，以破坏或表面存在的有机杂质或使其去活。
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CN106267371A (zh) * 2011-12-27 2017-01-04 (株）奥齿泰种植体 增进初期稳定性的用于牙科的种植体及其制造方法
CN104349743A (zh) * 2012-05-30 2015-02-11 京瓷医疗株式会社 牙植入体
CN105916678A (zh) * 2014-01-16 2016-08-31 学校法人冲绳科学技术大学院大学学园 由选定尺寸的纳米颗粒制成的分级氧化的钽多孔膜的设计和组装及其牙科和生物医疗植入物应用
CN109195641A (zh) * 2016-02-12 2019-01-11 纳米桥接分子股份公司 采用膦酸化合物的改进的植入物处理
CN109195641B (zh) * 2016-02-12 2021-07-27 纳米桥接分子股份公司 采用膦酸化合物的改进的植入物处理
CN114343894A (zh) * 2022-02-17 2022-04-15 北京冠美口腔医院管理有限公司 一种牙科种植体骨结合率加速器

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US20040210309A1 (en) 2004-10-21
CN100366300C (zh) 2008-02-06
EP1434607A1 (de) 2004-07-07

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