CN114364347A - 具有涂层式多孔结构的骨植入物 - Google Patents

具有涂层式多孔结构的骨植入物 Download PDF

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Publication number
CN114364347A
CN114364347A CN202080062447.5A CN202080062447A CN114364347A CN 114364347 A CN114364347 A CN 114364347A CN 202080062447 A CN202080062447 A CN 202080062447A CN 114364347 A CN114364347 A CN 114364347A
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China
Prior art keywords
coating
lattice structure
porous lattice
open
bone implant
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Pending
Application number
CN202080062447.5A
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English (en)
Inventor
H·D·林克
N·柯尼希
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Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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Publication of CN114364347A publication Critical patent/CN114364347A/zh
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Abstract

本发明涉及一种骨植入物，其具有主体(2)，所述主体(2)在其外部区域中具有开放晶胞式多孔晶格结构(3)，所述开放晶胞式多孔晶格结构(3)由大量规则布置的基本晶胞(4)形成，其中，所述基本晶胞(4)实施为拼装式结构并且各自由内腔(40)和围绕所述内腔(40)的多个相互连接的晶棱(41，42，43，44)构成。所述多孔晶格结构(3)设置有包括磷酸钙的骨生长促进涂层(5)，其中，所述磷酸钙涂层(5)具有至多1重量％的羟基磷灰石含量并形成到达所述多孔晶格结构(3)的深部内的孔内涂层。因此，本发明提出了一种特殊的涂层变型例，并因此打破了迄今为止普遍的思想，即，将涂层相对容易地施加并良好地粘附到植入物的表面上。

Description

具有涂层式多孔结构的骨植入物
技术领域
本发明涉及一种骨植入物，其具有主体，所述主体在其外部区域中具有开放晶胞式多孔晶格结构，所述开放晶胞式多孔晶格结构设置有包括磷酸钙的骨生长促进涂层。
背景技术
在植入物、尤其是待植入到骨内或骨上的内置假体和增强物的情况下，特别需要考虑在植入物和骨之间的生理上有利和稳定的连接。此外，期望的是，尽可能快地建立该连接，以实现患者的顺利再活动。为此目的，已知的是，为植入物设置骨生长促进涂层。这促进了骨细胞的生长并因此加速了植入物在骨内或骨上的向内生长。在本文中，涂层是被施加到光滑表面还是被施加到结构化表面在根本上是无关紧要的。在这两种情况下，涂层都实现了它的用途。
已知有各种材料用于涂层。它们的共同点是它们具有生物活性，尤其是具有骨生长促进特性。根据材料的不同，涂层可以以各种方式被施加，例如通过等离子喷涂、溅射或通过浸浴。一种自1990年代以来就广为人知的具有有利的骨生长促进特性的材料是磷酸钙(CaP)。尤其是对于薄的和可溶性涂层的临床应用来说，它建立在移植学中。
最近，通过添加方法(例如在3D打印技术中)制造的植入物已广为人知，由此可以生成规则的大孔结构。这在专业领域中也被称为小梁结构。小梁结构原本就已具有有利的向内生长行为。这种结构只能在有限程度上受益于具有公知的磷酸钙的涂层。已知一种特殊形式，其中使用钙/磷酸盐比率为1.1的磷酸钙作为涂层，其中，设置有至少70％的钙磷石含量和高达30％的羟基磷灰石含量。
发明内容
本发明基于的目的是提供一种开头提到的类型的骨植入物，该骨植入物具有改进的向内生长行为。
根据本发明的解决方案在于独立权利要求的特征。有利的改进方案是从属权利要求的主题。
一种骨植入物，其具有主体，该主体在其外部区域中具有开放晶胞式多孔晶格结构，该开放晶胞式多孔晶格结构由大量规则布置的基本晶胞形成，其中，基本晶胞实施为拼装式结构并且各自由内腔和围绕该内腔的多个相互连接的晶棱构成，其中，多孔晶格结构设置有包括磷酸钙的骨生长促进涂层，根据本发明规定的是，磷酸钙涂层具有至多1重量％、优选小于1重量％的羟基磷灰石含量并形成到达多孔晶格结构的深部中的孔内涂层。
以下首先说明一些使用的术语：
“开放晶胞式”多孔晶格结构应理解为，这些孔不是各自本身分开的，而是各个孔相互连接。因此，总体上产生一种开放式晶胞结构，其中，这些孔形成在各个晶胞中。
“拼装式结构”应理解为，该结构是加成制造的。这里可以考虑用于加成制造的各种方法。例如电子束熔化或选择性激光熔化等3D打印方法特别适用。
在本文中，“到达多孔晶格结构的深部中”应理解为，孔的内涂层不仅到达位于表面处的孔中，而且还涵盖位于材料内更深处(即远离表面)的孔，尤其是在材料中远离表面有多个(孔)层的孔。
“纤锌矿结构”应理解为一种以纤锌矿晶体形式为模型形成的结构(类似于金刚石结构应理解为以金刚石晶体形式为模型的结构)。
本发明的核心思想是修改和改进本身已知的磷酸钙涂层，使其实际上不含羟基磷灰石(至多1重量％，优选甚至小于1重量％)。从现有技术已知的磷酸钙涂层通常具有良好的20重量％或更多的羟基磷灰石含量，正如开头提到的特殊形式一样。由于根据本发明，实际上在用于涂层的磷酸钙中不再含有羟基磷灰石，因此如本发明所认识到的那样，可以获得更高的溶解度。本发明在第二步中利用这一优点，以便还为由基本晶胞产生的空腔在其深部内提供涂层，并因此可以更大程度地利用高溶解度。
因此，本发明提出了一种特殊的涂层变型例，并因此打破了迄今为止普遍的思想，即，将涂层相对容易地施加并良好地粘附到植入物的表面上。由于极低的羟基磷灰石含量或没有羟基磷灰石含量，本发明放弃了通常用于植入物涂层的磷酸钙材料固有的良好粘附性。乍一看，这可能看起来很荒谬，但本发明已经认识到，可以从粘合强度降低的明显缺点中实现决定性的优点。也就是说，这开辟了这样一种可能性，即这种本身粘附性差的磷酸钙可以更深地引入到开放晶胞式结构中，并因此也可以在开放晶胞式结构的深部内利用骨生长促进特性。令人惊讶的是，这会产生明显的积极效果，即骨细胞更快地生长到植入物中，而不会失去良好的长期效果。这在现有技术中是前所未有的。
优选地，磷酸钙涂层如此生成，使得其具有包括钙磷石和三斜磷钙石的晶相。这种组合式晶相为至少90重量％，优选至少95重量％。根据本发明的羟基磷灰石的极小含量允许钙磷石/三斜磷钙石的组合式晶相具有非常高的含量，该含量可以在必要时甚至为99％或更多。在本文中，优选地规定的是，钙磷石含量不小于65重量％。对于三斜磷钙石含量，没有下限。由于钙磷石由吸收骨植入物的生物体更好地降解，因而尤其是由于最少含量的钙磷石而可以确保最佳的溶解度并因此确保骨向内生长的效果。
符合目的地，磷酸钙涂层的平均厚度如此测量，使得基本晶胞的内腔保持相互连接，优选介于10μm和25μm之间，更优选为15μm+/-5μm。因此，尽管有涂层，也仍保留开放晶胞式结构，这有利于成骨细胞渗透到晶胞中。由此改善了骨整合行为。
此外，磷酸钙涂层优选地具有在1.0至1.2、优选1.05至1.15的范围内的钙/磷酸盐比率。在此，较高的磷酸盐含量(与现有技术的约1.6的通常比率相比)确保了更大的溶解度，这反过来促进了骨向内生长行为，尤其是与结构的深部内的涂层一起。此外，磷酸钙涂层优选地具有钙磷石相，该钙磷石相为至少90重量％，优选至少95重量％(并且必要时高达100重量％)。使用该比率，可以实现磷酸钙中的高的钙磷石含量，而羟基磷灰石最少或没有羟基磷灰石，具有上述有益效果。尤其地，可以如此实现，使得磷酸钙涂层被施加到基本晶胞的拼装式结构的所有侧上，尤其是它们的晶棱上。尤其地，可以形成具有磷酸钙涂层的孔的全向(全方位)衬里，即使在具有复杂或底切结构的孔的情况下也是如此。
此外，符合目的地规定的是，磷酸钙涂层是未退火的。一方面，这简化了制造，另一方面具有的优点是，可以避免如由退火引起的钙磷石含量的不期望的减少。
有利地，基本晶胞分层布置，其中，多个层叠加布置，优选地实施为开放晶胞式小梁结构。因此可以提供一种更深到达的开放晶胞式结构，该开放晶胞式结构也能够通过骨整合实现更深的向内生长。在本文中，符合目的地，磷酸钙涂层也被施加到更深层内，优选地被施加到所有层内。在本文中，更深的层应理解为不是直接位于表面上而是更深地位于材料中的层。由此进一步改善了植入物与周围骨之间的连接。由此有利于短期和长期紧固安全性。
符合目的地，开放晶胞式多孔晶格结构实施为3D打印，优选地借助电子束熔化(Electron Beam Melting-EBM)或选择性激光熔化(Selective Laser Melting-SLM)。这样可以合理地使用金属材料快速且以受控的方式制造部件，而且恰好是那些具有复杂和大量底切部和空腔的结构的部件。基本晶胞的结构可以在本文中精确地限定。这使得晶胞和形成它们的元件，尤其是它们的晶棱的限定布置成为可能。特别地，这些方法适用于采用生物相容性材料来制造植入物，尤其是金属材料，选自包括纯钛、钛合金、钴铬合金、钽、不锈钢和锆的组，优选采用2级或4级钛。
有利地，主体由与开放晶胞式多孔晶格结构相同的材料构成。因此，同样有利的生物相容性材料也可以用于主体。此外，这实现了在开放晶胞式多孔晶格结构和实际主体之间的无缝且必要时无级的过渡。此外，因此实现了更合理的制造。当主体还具有进行支承的区域(支承区域)时尤其适用。符合目的地，主体也可以具有一定的孔隙率，但该孔隙率通常偏离开放晶胞式多孔晶格结构并且优选地更低。特别符合目的的是，支承区域采用实心材料来实施。这不仅产生更大的机械强度，而且可以在隔壁的意义上实现阻塞效果，例如以便界定内部区域和外部区域或防止诸如骨水泥和/或体液的材料通过。
特别符合目的的是，支承区域可以与开放晶胞式多孔晶格结构一体地实施。这实现了特别合理的制造和无级的过渡。恰好后者提供了对周围组织的刺激最小的优点，因此进一步有利于向内生长行为。
优选地，基本晶胞采用纤锌矿结构来实施。纤锌矿结构与已知的金刚石结构的不同之处在于，金刚石结构在空间的所有三个维度上具有相同的刚度，而纤锌矿结构在空间方向上具有不同的刚度。这使得刚度行为能够借助纤锌矿结构更好地适配于解剖条件，结果，因此提高了植入物的生物相容性。
有利的，基本晶胞实施为大孔。在当前情况下，这应尤其理解为，基本晶胞以它们的内腔形成大孔，这些大孔的宽度在介于0.4mm和2mm之间、优选0.7mm至1.5mm的范围内。在这里，多孔结构的深度以符合目的的方式如此选择，使得至少两层基本晶胞彼此叠置。
这种开放晶胞式大孔结构以大的连接自由空间为骨的交联向内生长提供了特别有利的条件。
优选地，与由基本晶胞形成的孔的相对较大的实施不同，涂层实施为相对较薄。符合目的地，涂层具有仅介于10μm和20μm之间的厚度。使用这种薄涂层，可以实现一种由基本晶胞形成的大孔的内衬，并且更确切地如此实现，使得完美地保留了孔隙率以及尤其是开放晶胞式结构(即各个自由空间之间的连接)。这对于骨向内生长行为特别有利，更确切地说，无论是对于骨诱导还是对于骨传导都特别有利。符合目的地，在一方为基本晶胞电池的自由空间的宽度与另一方为涂层的厚度之间的比率如此选择，使得自由空间的宽度至少是涂层的厚度的十倍，优选地介于30倍和200倍之间。
本发明还涉及一种用于制造相应涂层式骨植入物的方法，该涂层式骨植入物具有主体，该主体在其外部区域中具有开放晶胞式多孔晶格结构，该开放晶胞式多孔晶格结构由大量规则布置的基本晶胞形成，该方法具有以下步骤：将规则布置的基本晶胞如此构建为分别由内腔和围绕该内腔的多个相互连接的晶棱构成的拼装式结构，使得内腔相互连接；用包括磷酸钙的骨生长促进涂层对多孔晶格结构进行涂层；其中，根据本发明规定的是，在进行涂层时，涂层以至多1重量％的羟基磷灰石含量制成，并作为孔内涂层被施加到多孔晶格结构的深部内。符合目的地，涂层如此执行，使得涂层具有晶相，该晶相包括钙磷石和三斜磷钙石，并且该晶相为至少90重量％，优选至少95重量％，其中，钙磷石含量不小于65重量％。为了更详细的说明，参考上面的描述。
优选地，涂层作为沉淀物被施加到多孔晶格结构的所有侧上，优选地借助电化学方法。因此，可以实现全向孔内涂层，即用骨生长促进涂层对孔加衬里。有利地，对于电化学方法，使用电流，该电流遵循在初始峰值电流之后回落到较低工作电流的电流曲线。本发明已经认识到，这种减小的电流导致改进的沉淀反应，尤其是磷酸钙的具有钙磷石/三斜磷钙石的组合式晶相在基本晶胞的结构元件上、更确切地说特别是在结构的深部内的沉淀反应。此外，因此可以可靠地实现均匀的薄涂层。
此外，优选地省去电化学加工之后的后续退火。因此可以避免不期望的晶体转变，从而磷酸钙的钙磷石相继续保持所需的高含量。
对于进一步的有利设计方案和更详细的描述，参考对上述植入物的说明，该说明也相应地适用于该方法。
总之，可以确定的是，使用根据本发明的涂层可以实现改善的骨向内生长，如测试已证明的那样。
附图说明
下面参照附图基于有利的实施例更详细地说明本发明。在附图中：
图1示出了根据本发明的一实施例的植入物的一实施例；
图2示出了根据图1的植入物的多孔结构的基本晶胞的详细图；
图3示出了基本晶胞和形成这些基本晶胞的元件的示意图；
图4中的a、b示出了多孔结构的两个正交方向的剖视图；
图5示出了根据本发明的第二实施例的增强物的图像；
图6中的a、b示出了根据图5的增强物的示意性的侧视图和前视图；
图7示出了表示骨向内生长行为的比较表；以及
图8示出了根据本发明的电化学涂层时的电流分布图。
具体实施方式
根据本发明的植入物的第一实施例在图1中示出。在本文中，该植入物是用于膝关节内置假体(未图示)的胫骨部件的锥体1。
锥体1在胫骨的近端部处形成有缺陷的骨材料的替代物，以便填充由于缺乏有损伤的骨材料而产生的空腔。这样提供了一个完整基座，膝关节内置假体的胫骨部件可以牢固地布置在该基座上。为此目的，锥体1是使用开放晶胞式多孔晶格结构来制造的，该开放晶胞式多孔晶格结构设置有根据本发明的涂层以改善骨材料的生长或向内生长。在本文中，开放晶胞式多孔晶格结构3被施加到主体2上。
尤其是得益于在锥体1的外侧上布置这种开放晶胞式多孔晶格结构3，可以实现周围胫骨-骨(未图示)的骨材料的良好向内生长行为，由此产生锥体1在胫骨中的快速和安全的紧固。
多孔结构3由大量规则布置的基本晶胞4形成。基本晶胞4及其在周围基本晶胞中的集成的详细图在图2中示出。基本晶胞4具有内腔40，该内腔40与相邻的基本晶胞4'的内腔40'连接。基本晶胞沿着分层平面49规则布置。有利地，多个分层平面叠加布置。
基本晶胞的规则布置可以从图4中的a、b的侧视图中很清楚地看出。它们示出了沿限定分层平面49的两个正交轴(参见图3中的x轴、y轴)的等距视图。可以看出，在两个方向上产生不同的横截面视图，尤其是关于内腔40的设计。这是所用晶体结构即纤锌矿结构的特殊性质。纤锌矿结构确保的是，如此形成的开放晶胞式多孔晶格结构在不同的空间方向上具有不同的压缩刚度，这在适配于骨的解剖条件方面是有利的。还可以看到，相邻的内腔40相互连接，从而由基本晶胞4以它们的内腔40形成的大孔以开放晶胞的方式相互连接(它们形成所谓的“连通孔”)。
基本晶胞4的实际结构在图3中示意性示出。在所示的实施例中，基本晶胞4由基本元件45形成，这些基本元件45各自实施为四足体。不言而喻，也可以设置除四足体以外的其他基本元件。这些四足体中的每一个具有实施为晶棱的四个腿41、42、43、44，这些腿各自在一端部处相互连接并因此形成一个节点。四足体可以规则地或不规则地形成，具有相等的腿长或不同的腿长。所示的是一常规实施方式，其中这些腿的长度相等，并且每个腿与其他腿中的每一个围成相同的角度。在将四足体布置在平坦分层中时，三个腿41、42、43各自竖立布置在一平面上，而第四腿44垂直于该平面取向。因此，该第四腿代表与布置在其上方的分层平面的四足体的连接(参见图3)。
通过选择分层平面的数量，可以控制开放晶胞式多孔晶格结构的深度。因此，可以设置例如三个或四个或五个叠加层(参见图4中的a、b)，但通常设置至少两个叠加层。作为用于开放晶胞式多孔晶格结构的材料，优选使用钛合金或纯钛。
第二实施例在图5和图6中示出。图5是摄影图像。该图示出了圆柱形增强物1'，例如它也可以例示性用于填充骨缺损或必要时还用于融合相邻骨元件、特别是椎体的目的。圆柱形增强物1'具有大致构成为套筒的主体2'，该主体2'为大体圆柱形设计。主体2'在其侧面上设置有开放晶胞式多孔晶格结构3'。如尤其是在图6中的a、b的示意图中可以清楚地看出，该开放晶胞式多孔晶格结构3'也由基本晶胞4形成，这些基本晶胞4具有它们的相互连接的内腔40，其中，基本晶胞4又由作为基本元件45的四足体组成。
如尤其是从图5中的摄影图像可以清楚地看出，由基本晶胞4形成的开放晶胞式多孔晶格结构3'设置有在图像中显得有些粗糙的涂层5。涂层5被平坦地施加到开放晶胞式多孔晶格结构3'上和主体2'的两个端部区域上，并且也进一步被施加到基本晶胞4的内腔40中的结构3'的深部内。
圆柱形套筒状主体2'的长度和宽度的示例性尺寸为12mm长度或6mm直径作为宽度。在本文中，形成开放晶胞式多孔晶格结构3'的基本晶胞4的内腔40具有约700μm的宽度，并且开放晶胞式多孔晶格结构3'的深度延伸超过约2000μm。在基本晶胞4中观察，由此产生近三层基本晶胞4的深度。
涂层5具有钙磷石和三斜磷钙石的组合式晶相，其含量为95重量％，其中，钙磷石的含量为至少65重量％。此外，涂层5给基本晶胞4的内腔40完全加衬里，更确切地说不仅在最高层中，而且在位于其下的层中。
根据本发明，由此产生在骨整合和骨传导的框架内的骨材料的显著改善的向内生长。使用具有相同设计的开放晶胞式多孔晶格结构但没有根据本发明的涂层5的比较植入物的比较测试结果在图7中示出。在那里，示出了定量组织形态学分析，其中，沿Y轴示出了以百分比表示的骨/植入物接触比率，更确切地说针对两个不同区域(ROI1和ROI2)。两个左柱对代表比较植入物(“C1”)，并且两个右柱对代表根据本发明的测试植入物(“T”)。每个柱对中的左柱示出了短期向内生长行为(4星期后测量)，并且每个柱对中的右柱示出了长期向内生长行为(26星期后测量)。可以清楚地看到，在根据本发明的植入物(“T”)的情况下，在4星期后已经实现了骨材料的极好的向内生长，其中，比较例仅在6倍的时间后，即26星期后才达到相似的值。这令人印象深刻地证明了根据本发明的涂层的骨生长促进特性。
符合目的地，电化学方法用于涂层。电化学涂层时的电流分布在图8中示出。
可以看出，最初设置了一个高峰值电流，然后将其降低到较低的工作电流。使用这种电流方案，可以实现特别适用于薄且均匀的涂层的特别好的磷酸钙沉淀反应，其中，产生了具有足足95％的高含量的组合式钙磷石/三斜磷钙石相。

Claims (15)

1.一种骨植入物，其具有主体(2)，所述主体(2)在其外部区域中具有开放晶胞式多孔晶格结构(3)，所述开放晶胞式多孔晶格结构(3)由大量规则布置的基本晶胞(4)形成，其中，所述基本晶胞(4)实施为拼装式结构并且各自由内腔(40)和围绕所述内腔(40)的多个相互连接的晶棱(41，42，43，44)构成，其中，所述多孔晶格结构(3)设置有包括磷酸钙的骨生长促进涂层(5)，其特征在于，所述磷酸钙涂层(5)具有至多1重量％的羟基磷灰石含量并形成到达所述多孔晶格结构(3)的深部内的孔内涂层。
2.根据权利要求1所述的骨植入物，其特征在于，所述磷酸钙涂层(5)具有晶相，所述晶相包括钙磷石和三斜磷钙石，并且所述晶相为至少90重量％，优选至少95重量％，其中，所述钙磷石含量不小于65重量％。
3.根据权利要求1或2所述的骨植入物，其特征在于，所述磷酸钙涂层(5)具有在1.0至1.2、优选1.05至1.15的范围内的钙/磷酸盐比率。
4.根据前述权利要求中任一项所述的骨植入物，其特征在于，所述磷酸钙涂层(5)的平均厚度如此测量，使得所述基本晶胞(4)的所述内腔保持相互连接，优选介于10μm和25μm之间，更优选为15μm+/-5μm。
5.根据前述权利要求中任一项所述的骨植入物，其特征在于，所述磷酸钙涂层(5)是未退火的。
6.根据前述权利要求中任一项所述的骨植入物，其特征在于，所述磷酸钙涂层(5)被施加到所述基本晶胞(4)的所述拼装式结构的所有侧上，尤其是它们的晶棱(41，42，43，44)上，优选地形成全向孔内涂层。
7.根据前述权利要求中任一项所述的骨植入物，其特征在于，所述基本晶胞(4)分层布置，其中，多个层叠加布置，优选地实施为开放晶胞式小梁结构，和/或所述基本晶胞(4)采用纤锌矿结构来实施。
8.根据前述权利要求中任一项所述的骨植入物，其特征在于，所述开放晶胞式多孔晶格结构(3)实施为3D打印，优选地借助电子束熔化(Electron Beam Melting-EBM)或选择性激光熔化(Selective Laser Melting-SLM)。
9.根据前述权利要求中任一项所述的骨植入物，其特征在于，所述主体(2)由与所述开放晶胞式多孔晶格结构相同的材料构成。
10.根据前述权利要求中任一项所述的骨植入物，其特征在于，所述主体(2)具有支承区域，所述支承区域的孔隙率小于所述开放晶胞式多孔晶格结构(3)的孔隙率，其中，所述支承区域优选地实施为实心，和/或所述支承区域和所述开放晶胞式多孔晶格结构实施为一体。
11.根据前述权利要求中任一项所述的骨植入物，其特征在于，所述基本晶胞(4)的所述内腔(40)形成大孔，所述大孔的宽度至少是所述涂层(5)的厚度的十倍，优选介于30倍和200倍之间，和/或所述孔的宽度在介于0.4mm和2mm之间、优选0.7mm至1.5mm的范围内，并且所述涂层(5)具有介于10μm和20μm之间的厚度。
12.一种用于制造涂层式骨植入物的方法，所述涂层式骨植入物具有主体(2)，所述主体(2)在其外部区域中具有开放晶胞式多孔晶格结构，所述开放晶胞式多孔晶格结构由大量规则布置的基本晶胞形成，所述方法具有以下步骤：
将所述规则布置的基本晶胞如此构建为分别由内腔和围绕所述内腔的多个相互连接的晶棱构成的拼装式结构，使得所述内腔相互连接；
用包括磷酸钙的骨生长促进涂层对所述多孔晶格结构进行涂层；
其特征在于，所述涂层以至多1重量％的羟基磷灰石含量制成，并作为孔内涂层被施加到所述多孔晶格结构的深部内。
13.根据权利要求12所述的方法，其特征在于，所述涂层具有晶相，所述晶相包括钙磷石和三斜磷钙石，并且所述晶相为至少90重量％，优选至少95重量％，其中，所述钙磷石含量不小于65重量％。
14.根据权利要求12或13所述的方法，其特征在于，所述涂层作为沉淀物被施加到所述多孔晶格结构的所有侧上，优选地借助电化学方法。
15.根据权利要求14所述的方法，其特征在于，对于所述电化学方法，使用电流，所述电流遵循在初始峰值电流之后回落到较低工作电流的电流曲线。
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