CN107865713A - 将假体植入物纹理化的方法 - Google Patents
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Abstract
本发明题为:“将假体植入物纹理化的方法”。本发明提供了一种处理金属整形外科植入物的关节表面的方法,该方法包括:抛光该表面,在第一抛光步骤之后用喷砂介质对该表面喷砂,在喷砂步骤之后抛光金属整形外科植入物的经喷砂的表面。喷砂步骤使表面粗糙化,以形成由峰和谷限定的表面斜率Rsk/Ssk。第二抛光步骤将表面斜率降低为负斜率Rsk/Ssk,并且产生了可接受的平均粗糙度Ra/Sa。经处理的关节面与对应的支承关节面的界面处的润滑性得到了改善,从而提高了抗磨损性。这两个抛光步骤可通过用研磨介质拖刮式修整表面来执行。
Description
技术领域
本公开整体涉及整形外科假体,更具体地,涉及制备整形外科植入物系统部件中一个部件的关节运动表面的方法。
背景技术
根据不同的运动范围,人体肌肉骨骼系统的关节运动牵涉相邻骨的移动。例如,人体膝关节的移动牵涉股骨、胫骨和髌骨的移动。具体地讲,在屈曲和伸展过程中,当髌骨与股骨作关节运动时,股骨的远侧端部和胫骨的近侧端部通过一系列复杂的移动相对于彼此进行关节运动。类似地,人体髋关节的移动牵涉股骨相对于髋臼的移动,并且肩关节的移动牵涉肱骨相对于关节盂的移动。损伤(例如,创伤)或疾病可损害骨、关节软骨以及与这些关节相关联的骨的韧带,这可最终影响自然关节正常发挥功能的能力。因此,为了给患者提供更大的移动性,已经开发出整形外科假体并将其植入关节骨的经外科准备的端部中。
例如,全膝关节置换术中的典型整形外科假体10在图1和图2中示出。所示假体包括:待连接到患者的近侧胫骨的胫骨部件12或胫骨托;待连接到患者的远侧股骨的股骨部件14;以及定位在胫骨托与股骨部件之间的支承部件(或胫骨插件)16。
一旦植入,当膝关节通过屈曲和伸展进行移动时,股骨部件上的关节面18,20支承胫骨插件16的近侧表面上的关节面22,24并抵靠这些关节面进行关节运动。股骨部件14上的凹槽提供第三关节面26,当膝关节屈曲和伸展时,该第三关节面抵靠髌骨植入物部件(未示出)上的支承表面进行关节运动。植入物12,14的其它表面26,28在植入时面向骨,并且可具有粘固剂凹坑或纹理化表面,以促进骨长入。
髋关节置换术中的典型整形外科假体30在图3至图5中示出。髋关节假体30包括:金属杆32、金属股骨头34和髋臼植入物组件36,该髋臼植入物组件包括髋臼杯38和支承部件(髋臼内衬)40,该支承部件固定到髋臼杯38上并接纳股骨头34。
在图4所示的实施方案中,与图3的杆32相比,杆32A有一些不同之处。在两幅图中,股骨植入物是模块化植入物,包括杆32或32A部件与股骨头部件34的组件。头部件34限定关节曲面42,该关节曲面接纳在髋臼内衬40的关节凹面44内并抵靠该关节凹面进行关节运动。杆32的大部分长度限定从远侧端部47朝近侧延伸的向骨表面46,抵靠并面向骨(近侧股骨)。髋臼杯38的外表面也限定向骨表面48。
肩关节置换术中的典型整形外科假体50在图6中示出,其包括金属杆52、金属肱骨头54和关节盂部件56。常见的关节盂部件56包括金属部分和支承件58,该支承件固定到金属部分上并接纳肱骨头54或抵靠肱骨头进行关节运动。头部件54限定关节凸曲面60,该关节凸曲面接纳在支承件58的关节凹曲面62内并抵靠该关节凹曲面进行关节运动。杆52的大部分长度限定从远侧端部66朝近侧延伸的向骨表面64,抵靠并面向骨(近侧肱骨)。关节盂部件的外表面也限定向骨表面。图6示出了被植入近侧肱骨和关节盂中的肩关节假体50。
在此类典型的整形外科假体中,胫骨托12、远侧股骨部件14、股骨杆32、股骨头34、髋臼杯38、肱骨杆52、肱骨头54和部分关节盂部件56通常由金属制成,诸如钴铬合金或钛合金(诸如,例如钛合金Ti-6Al-4V)。支承部件(胫骨插件16、髋臼内衬40或关节盂支承件58)通常由聚合物制成,或者就髋关节假体而言,可包括金属内衬或陶瓷内衬。在一些情况下,整个胫骨部件和整个关节盂部件可包含聚合物。
用于支承部件16,40,58的聚合物可以是超高分子量聚乙烯(UHMWPE)。UHMWPE可包含例如交联材料。用于交联、骤冷或以其它方式制备UHMWPE的技术在多个已公布美国专利中有所描述,这些专利的示例包括:授予Sun等人的美国专利5,728,748(及其对等专利)、授予Merrill等人的美国专利5,879,400、授予Saum等人的美国专利6,017,975、授予Saum等人的美国专利6,242,507、授予Saum等人的美国专利6,316,158、授予Shen等人的美国专利6,228,900、授予McNulty等人的美国专利6,245,276以及授予Salovey等人的美国专利6,281,264。这些美国专利中每一个专利的公开内容均全文以引用方式并入本文。可例如通过添加抗氧化剂(例如维生素E)来处理支承材料的UHMWPE以稳定其中存在的任何自由基。利用抗氧化剂来稳定UHMWPE的技术在例如以下专利中有所公开:美国专利公布20070293647A1(序列号11/805,867)和美国专利公布20030212161A1(序列号10/258,762),这两个专利的名称均为“Oxidation-Resistant And Wear-Resistant Polyethylenes For Human JointReplacements AndMethods ForMaking Them”。
这些植入物系统中的每一个植入物系统具有一些共同特征:一个植入物部件14,34,54(通常为金属或陶瓷)的关节运动表面18,20,26,42,60支承着支承部件16,40,56的关节面22,24,44,62并抵靠关节面进行关节运动。反复使用数年之后,这些部件之间相互的反复关节运动可导致支承部件16,40,56发生磨损。支承部件过度磨损可导致以下问题:假体关节需要被移除,并通过修正术用另一假体植入物替换。
为解决磨损问题,已提出了各种解决方案。例如,已经尝试通过优化金属关节活动表面的抛光以实现高光泽度来减小磨损。然而,这种抛光工艺成本很高。一些人建议通过蚀刻或阳极氧化来提供纹理化表面,以容纳生物流体,从而提高润滑度。参见例如WO2015/034471A1。
发明内容
本发明实现了以下目标:以具有成本效益的方式提高整形外科植入物假体的抗磨损性能。
根据一个方面,本发明通过提供一种处理整形外科植入物的关节运动表面的方法来实现该目标,该方法包括:抛光整形外科植入物的关节运动表面,对植入物的抛光表面喷砂,之后抛光经喷砂的表面。
在一个具体实施方案中,抛光关节运动表面的步骤包括通过研磨介质拖刮式修整关节运动表面。类似地,抛光经喷砂的表面的步骤可包括通过研磨介质拖刮式修整经喷砂的表面。
喷砂步骤用喷砂介质执行。在一个具体实施方案中,喷砂步骤包括湿式喷砂。湿式喷砂步骤可以用具有125-180um(B100)或0-125um(B125)范围内的尺寸的球形珠介质,按体积计介质浓度在15%-25%的范围内,并且在30-40psi的压力下执行。在该实施方案中,喷砂步骤提高了金属整形外科植入物的表面粗糙度。
在一个更加具体的实施方案中,喷砂前的抛光步骤比喷砂后的抛光步骤耗时更长。
在这些实施方案的任一实施方案中,整形外科植入物部件的关节运动表面在第二抛光步骤之后具有负表面斜率(Rsk,Ssk)。
在另一个更加具体的实施方案中,第一抛光步骤包括在第一时间段内通过研磨介质拖刮式修整关节运动表面,并且抛光经喷砂的表面的步骤包括在第二时间段内通过研磨介质拖刮式修整经喷砂的表面。在这些实施方案中,第一时间段可以是最大40分钟,并且第二时间段可以是最大20分钟。针对材料的不同起始状况以及所用材料或合金的类型,最大时间段可以更长。
在这些实施方案的任一实施方案中,用于第一拖刮式修整步骤的研磨介质可包括塑料陶瓷复合物,并且用于第二拖刮式修整步骤的研磨介质可包括结合有陶瓷抛光介质的坚果壳或玉米芯。
在这些实施方案的任一实施方案中,喷砂步骤可形成具有由多个峰值和谷值限定的表面粗糙度(Ra/Sa)和斜率(Rsk/Ssk)的表面,第二抛光步骤降低了该表面粗糙度(Ra/Sa)并提高了负斜率Rsk/Ssk。例如,在第二拖刮式修整步骤之后,表面斜率Rsk/Ssk可为-1至-3。第二抛光步骤之后的平均表面粗糙度可小于0.1微米。表面特征(粗糙度和斜率)可通过白光干涉法测量。
在这些实施方案的任一实施方案中,整形外科植入物的关节运动表面可包含金属,诸如标准钴铬合金或钛合金。
在这些实施方案的任一实施方案中,整形外科植入物可包括膝关节植入物的远侧股骨部件或胫骨托、髋关节植入物的股骨头、或肩关节植入物的肱骨头或关节盂部件。
附图说明
背景技术和具体实施方式具体地参考以下附图,其中:
图1是整形外科膝关节假体系统的示例的透视图;
图2是图1的膝关节假体系统的分解图;
图3是整形外科髋关节假体系统的示例的透视图;
图4是整形外科髋关节假体系统的示例的股骨杆和股骨头的分解透视图;
图5是用于整形外科髋关节假体系统中的髋臼杯和内衬的示例的分解图;
图6是被示出为植入在肱骨和肩关节上的整形外科肩关节假体系统的示例的透视图;
图7是用于修整整形外科假体系统(诸如图1至图6所示的系统)的金属部件中的一个或多个的关节面的工艺步骤的流程图。
具体实施方式
虽然本发明的概念易于具有各种修改形式和替代形式,但本发明的具体示例性实施方案已在附图中以举例的方式示出,并且将在本文中详细说明。然而应当理解,本文无意将本公开限制为所公开的具体形式,而是相反,本发明的目的在于涵盖落入如由所附权利要求限定的本发明的精神和范围内的所有修改形式、等同形式和替代形式。
在本公开中有关本文所述的整形植入物和患者的自然解剖部分均可以通篇使用表示解剖学参考的术语,例如前侧、后侧、内侧、外侧、近侧、远侧、上、下等。这些术语在解剖学研究和整形外科领域都具有公知的含义。除非另外指明,否则说明书和权利要求中使用的此类解剖参考术语旨在符合其公知的含义。
与表面粗糙度表征相关的术语可在其公开内容中通篇使用。例如,使用了平均表面粗糙度Ra,Sa和表面斜率Rsk,Ssk。除非另外指明,否则这些术语的使用旨在符合其公知的含义。另外,除非明确排除在外,表面纹理测量和/或表征的标准方法以及用于测量和/或表征表面纹理的标准设备旨在可相对于本发明使用。
尽管下面的结果以三维结果(Sa和Ssk)报告,但应当理解,这些结果应当与2维测量值(Ra和Rsk)类似。除非另外明确指出,否则提及的表面粗糙度和斜率的具体数值应当理解为是对Sa与Ra、以及Ssk与Rsk的提及。
在本发明的工艺中,起始点是具有关节运动表面的标准整形外科植入物部件,诸如例如远侧股骨部件14、股骨头34或肱骨头54。该植入物可以由标准金属制成,诸如整形外科植入物所用的标准CoCrMo合金或钛合金(但除非权利要求书明确指出,否则本发明并不限于任何具体合金)。应当理解,这些植入物部件仅被视为示例;除非权利要求书明确指出,否则本发明不限于这些部件。另外,期望本发明的原理也可适用于陶瓷整形外科植入物部件,诸如例如陶瓷股骨头。
一般来讲,本发明的工艺涉及:抛光植入物部件的关节运动表面,对经抛光表面喷砂,然后抛光经喷砂的表面。
如本文所用,“抛光”是指移除所抛光表面上的材料以降低所抛光表面粗糙度的任何标准研磨制造工艺。标准抛光工艺包括例如研磨介质中的振动式修整和研磨介质中的滚筒抛光。就下文的实施例而言,用研磨介质拖刮式修整关节运动表面经证明是抛光关节运动表面的一种有效方式。
相比之下,“喷砂”是指使表面发生变形而不是移除表面上的材料的表面处理。一般来讲,喷砂是指在压力下将介质向表面推进以作用于该表面。就下文的实施例而言,对经抛光的关节运动表面喷砂会通过塑料变形在该表面处形成谷和峰。这些峰可在最终的抛光步骤中通过研磨被移除,以产生具有可接受的表面粗糙度和负斜率的表面。
首先可将植入物部件安装到夹具上,并且置于包括拖刮式修整研磨介质的容器中。例如,可使用诸如Rosler RKH 4(聚酯树脂/陶瓷介质复合物)的塑料研磨介质。将安装的植入物部件浸没,然后以行星运动方式穿过研磨介质。例如,当夹具自身旋转以使植入物部件移动穿过介质(其自身可以是旋转容器)时,植入物部件可围绕轴线旋转。在植入物部件通过湿式喷砂工艺进一步纹理化之前,该步骤将抛光植入物部件。例如,在被拖动穿过复合介质长达40分钟之后,植入物部件的平均表面粗糙度Ra/Sa可为0.03μm。第一抛光步骤的时间长度可不同,具体取决于材料的起始状况和所用材料或合金的类型。
在该第一抛光步骤之后,再次用夹具保持植入物部件,然后喷砂以进一步使所需表面粗糙化。例如,可使用湿式喷砂工艺,其中在受控时间内(例如,1分钟)将加压的喷砂介质浆液(例如,在30或40psi的压力下,在水中按体积计为15%-25%的Zirblast B100或Microblast B125型氧化锆介质)施加到所需表面上。该步骤将通过形成多个峰和谷使植入物部件的关节运动表面进一步粗糙化。
喷砂之后,植入物部件的表面粗糙度可表征为包括多个峰和谷,形成具有Ra例如为0.3μm、Rsk为0至-1的表面粗糙度。
为了减少或消除喷砂步骤所形成的峰,同时保留所形成的谷,喷砂步骤之后可进行另一拖刮式修整或抛光步骤。例如,可将用合适的夹具保持的植入物部件浸入另一拖刮式研磨介质(诸如,Rosler Supervelat玉米芯抛光介质,这是一种基于玉米芯的介质,该介质包括结合有陶瓷抛光介质的玉米芯,www.rosler.us;GmbH)中,并且以将会消除或基本消除峰的速度拖动其穿过该介质一段时间。预期此类的处理步骤可降低平均粗糙度Ra/Sa,并形成更小的表面斜率Rsk/Ssk。
在整个抛光和喷砂步骤中,可以控制植入物部件暴露于研磨抛光介质和喷砂介质的表面,使得仅暴露关节运动表面(诸如,股骨部件14的表面18,20、头34的表面42、或头54的表面60)。因为常常期望向骨表面具有不同的表面特征,如果需要的话,可通过遮蔽或保持这些部件的夹具的结构来保护表面26,28,46,48,64以避免暴露于介质中。
可使用商购设备执行拖刮式修整和喷砂步骤。例如,适用于拖刮式修整步骤的设备可得自Metal Finishing公司(www.rosler.us; GmbH)。此设备允许将多个植入物部件安装到各个主轴上,各个主轴依次安装到转盘上使得主轴和转盘可以旋转,以使这些部件移动穿过研磨材料的料盆(料盆也可旋转)。适用于喷砂步骤的设备可得自Metal Finishing公司(www.rosler.us;GmbH),例如RWB 48湿式喷砂研磨室。
该工艺所用的研磨介质可以是用于制造医疗装置,根据工艺的阶段选择的标准打磨或抛光介质。例如,研磨介质可包括可商购获得的基于坚果壳或玉米芯的颗粒以及此类颗粒与其它材料(诸如,陶瓷)的复合物。“基于坚果壳或玉米芯的抛光介质”旨在包括可商购获得的介质,其中坚果壳或玉米芯结合有诸如陶瓷的另一材料。如本文所用,“研磨介质”旨在涵盖这些介质,以及用于传统抛光工艺的其它标准材料。抛光步骤可以是湿式或干式步骤。可选择所用研磨介质的具体特征以产生所需的表面光洁度特性。抛光步骤中的其它参数(诸如,旋转元件的旋转速度和拖动时间)也可调节以产生所需的表面光洁度特性。
类似地,工艺中所用的喷砂介质可以是标准喷砂介质。例如,可使用水中的陶瓷珠的基于氧化锆的浆液(“Zirblast”,Saint Gomain,Worcester,MA)。如本文所用,“喷砂介质”旨在涵盖陶瓷珠、玻璃珠和金属珠,以及用于传统喷砂工艺中的其它标准材料。喷砂工艺可以是湿式或干式工艺。可调节喷砂介质的具体特征和喷砂工艺的参数(诸如,压力和时间)以产生所需的表面光洁度特性。
为了将本发明的工艺与现有技术抛光工艺进行比较,按照下表所列制备样品CoCrMo圆盘(所有样品均为铸造的CoCrMo圆盘,ASTM F75,经过热处理[HIP和均质化]):
在上述样品2-4中,用于第一抛光步骤的基于塑料的研磨介质为Rosler RKH 4(聚酯树脂/陶瓷介质复合物)。此相同材料在塑料介质拖动步骤中用于样品5和6。用于样品2,3和6的基于坚果壳的介质为Rosler Polishing Grain SVK-747。
图7示出了样品3的工艺步骤。
如下文所述,上文所示样品的表面经表征以确定Sa和Ssk,并且还进行了销盘磨损测试。使用白光干涉法(Zygo NewView 5000,Middlefield,CT)进行表面表征。使用不同负载下的OrthoPOD销盘摩擦计(AMTI,Watertown,MA)和关节运动代表保罗曲线(Paul,Proc.Inst.Mech.Eng.181,8-15,1967)执行销盘磨损测试,其中负载峰值在1.98MCyc时为330N。销盘测试在37±2℃下使用牛血清(总蛋白质浓度为64.8mg/mL;HyCloneLaboratories Inc.,Logan,UT)辅以叠氮化钠和EDTA来完成。清洗销并称重,并且在整个测试过程中,根据ISO 14242-2:2000(E),用浸泡补偿法,使用线性回归分析,测定重量磨损率六次。润湿性通过Kruss液滴形状分析系统(DSA 10)和10μL水滴进行测量。金属部件抵靠包括从DePuy Synthes Joint Reconstruction商购的XLK UHMWPE的部件进行关节运动。此UHMWPE材料由GUR 1020树脂在50kGy下进行辐照并再融化而制成。
对于一些样品,也可在该过程中表征表面粗糙度。例如,对于样品组2,在喷砂步骤之后测量Sa和Ssk,分别为0.32μm和0.8。
样品组2和3的Sa值处于ISO 21534规定的0.1微米规格以内。对于样品组2和3,在最终的表面精抛光步骤之后,Ssk值为负。与高度抛光的对照样品1相比,这些样品还表现出更低的水滴接触角和磨损率。这些负斜率值表明该表面包括凹坑,据信这些凹坑可以将润滑剂捕获在支承表面上以提高液动润滑性。还期望这些凹坑可以夹带可能有害的磨损微粒。还期望这些样品在体内将更快表现出初始润滑性。
上述工艺可适用于植入物部件。例如,胫骨托12、股骨部件14、股骨头34或肱骨头54的关节运动表面可通过本发明的工艺修整,并且预期这些植入物部件将表现出对其相关联的支承件16,40,58的关节面的更高抗磨损性能。
因此,本发明的工艺预期可以具有成本效益的方式提高整形外科假体的抗磨损性能。
尽管在附图和上述说明中已详细地举例说明和描述了本公开的概念,但此类说明和描述应视为示例性的而不是限制性的,应当理解的是,仅示出和描述了示例性的实施方案,并且本公开的实质内的所有改变和变型都应受到保护。
本文所述装置和方法的多个特征使本发明具有多个优点。应当注意的是,本发明的装置和方法的替代实施方案可以不包括所有所述特征,但仍然可以具有这些特征的至少某些优点的有益效果。本领域的普通技术人员可容易地设计出他们自己的对于装置和方法的实施方式,该实施方式可结合本公开的特征中的一项或多项,并且落入本公开的精神和范围内。
Claims (22)
1.一种处理整形外科植入物的关节运动表面的方法,包括:
抛光所述整形外科植入物的所述关节运动表面;
对所述整形外科植入物的经抛光的表面喷砂;以及
抛光所述整形外科植入物的经喷砂的表面。
2.根据权利要求1所述的方法,其特征在于,抛光所述整形外科植入物的所述关节运动表面的步骤包括用研磨介质拖刮式修整所述整形外科植入物的所述关节运动表面。
3.根据权利要求1所述的方法,其特征在于,抛光所述整形外科植入物的经喷砂的表面的步骤包括用研磨介质拖刮式修整所述整形外科植入物的所述关节运动表面。
4.根据权利要求1所述的方法,其特征在于,喷砂包括湿式喷砂。
5.根据权利要求4所述的方法,其特征在于,喷砂包括用具有在B100至B125范围内的尺寸的陶瓷珠介质在30-40psi的压力下进行湿式喷砂以提高金属整形外科植入物的表面粗糙度。
6.根据权利要求1所述的方法,其特征在于,喷砂前的所述抛光步骤比喷砂后的所述抛光步骤耗时更长。
7.根据权利要求1所述的方法,其特征在于,所述整形外科植入物的所述关节运动表面在第二抛光步骤之后具有负表面斜率(Ssk)。
8.根据权利要求1所述的方法,其特征在于:
抛光所述整形外科植入物的所述关节运动表面的所述步骤包括在第一时间段内用研磨介质拖刮式修整所述整形外科植入物的所述关节运动表面;并且
抛光所述整形外科植入物的经喷砂的表面的步骤包括在第二时间段内用研磨介质拖刮式修整所述整形外科植入物的经喷砂的表面。
9.根据权利要求8所述的方法,其特征在于,所述第一时间段为最大40分钟。
10.根据权利要求8所述的方法,其特征在于,所述第二时间段为最大20分钟。
11.根据权利要求8所述的方法,其特征在于,用于第一拖刮式修整步骤中的所述研磨介质包括塑料陶瓷复合物。
12.根据权利要求8所述的方法,其特征在于,用于第二拖刮式修整步骤中的所述研磨介质包括基于坚果壳或玉米芯的抛光介质。
13.根据权利要求8所述的方法,其特征在于,所述喷砂步骤形成具有由多个峰和谷限定的表面斜率的表面,并且所述第二拖刮式修整步骤形成具有负斜率的表面。
14.根据权利要求8所述的方法,其特征在于,所述整形外科植入物的所述关节运动表面在所述第二拖刮式修整步骤之后具有-1至-3的表面斜率。
15.根据权利要求8所述的方法,其特征在于,所述整形外科植入物的所述关节运动表面在所述第二拖刮式修整步骤之后具有小于0.1微米的平均表面粗糙度。
16.根据权利要求15所述的方法,其特征在于,所述整形外科植入物的所述关节运动表面在所述第二拖刮式修整步骤之后具有-1至-3的表面斜率。
17.根据权利要求8所述的方法,其特征在于,所述整形外科植入物的所述关节运动表面包含金属。
18.根据权利要求17所述的方法,其特征在于,所述整形外科植入物的所述关节运动表面包含金属,所述金属选自包括钴铬合金和钛合金的组。
19.根据权利要求8所述的方法,其特征在于,所述整形外科植入物选自包括以下项的组:
整形外科膝关节植入物的远侧股骨部件;
整形外科膝关节植入物的胫骨托;
整形外科髋关节植入物的股骨头;
整形外科肩关节植入物的肱骨头;和
整形外科肩关节植入物的关节盂部件。
20.根据权利要求19所述的方法,其特征在于,所述整形外科植入物的所述关节运动表面:
在所述第二拖刮式修整步骤之后具有经白光干涉法测得的小于0.1微米的平均表面粗糙度(Sa);
在所述第二拖刮式修整步骤之后具有经白光干涉法测得的-1至-3的表面斜率(Ssk);并且
包含金属,所述金属选自包括钴铬合金和钛合金的组。
21.根据权利要求20所述的方法,其特征在于,喷砂包括用具有在B100至B125范围内的尺寸的陶瓷珠介质在30-40psi的压力下进行湿式喷砂以提高所述金属整形外科植入物的所述表面粗糙度。
22.根据权利要求21所述的方法,其特征在于:
所述第一时间段为最大40分钟;
所述第二时间段为最大20分钟;
用于所述第一拖刮式修整步骤中的所述研磨介质包括塑料复合物;并且
用于所述第二拖刮式修整步骤中的所述研磨介质包括基于坚果壳或玉米芯的抛光介质。
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