CN105164304B - 用于电外科器械的含ZrO2的涂层体系 - Google Patents

用于电外科器械的含ZrO2的涂层体系 Download PDF

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CN105164304B
CN105164304B CN201480021699.8A CN201480021699A CN105164304B CN 105164304 B CN105164304 B CN 105164304B CN 201480021699 A CN201480021699 A CN 201480021699A CN 105164304 B CN105164304 B CN 105164304B
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阿尔伯特·彼得·格哈德·詹森
沃尔克·德福林格
康耐特·阿克格茨
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Abstract

本发明涉及涂层体系，其包括至少一个主要由ZrO2构成的层，该层被用于给医用器械尤其是电外科器械的部件提供绝缘性能。

Description

用于电外科器械的含ZrO2的涂层体系
本发明涉及含ZrO2的涂层体系和施加该涂层体系至需要被电绝缘的电外科器械的部件的表面的方法。
发明背景
电外科手术是利用直接施加电流来切割和/或脱水组织并阻止血液流动的处理过程。它已经被用了许多年，但始终在完善和革新。
目前，电外科手术被用于医疗行业中的所有不同类型的作业。其中一些包括皮肤病手术、心脏手术、血管手术、整形手术和牙科手术。它在切割可能引起大量失血的身体区域和状况下是尤其有用的。
因为它用电力来凝结切口周围的血管，故它能尽量减少失血。在二十世纪三十年代开始采用电外科手术之后，已经能够实现许多外科手术，因为电外科手术工具能控制流血，而使用手术刀是无法控制流血的。
原则上，可以分为单极电外科手术和双极电外科手术。
在单极电外科手术中，单个电极或铅条/器械被用于传输电流至手术位点或切开位点。电流经过接地的患者身体。较高的电压被用于凝结，而较低的电压被用于切割。但是在双极电外科手术中，患者身体未被用作导体来传输电流，因此缘故，此技术在热损伤扩散至附近组织造成患者受伤潜在风险的情况下是最合适的。过度的热扩散例如可能损伤与正在手术的身体区域相邻的神经。
通常，当实施双极电外科技术时，电流被输送经过双极器械的一个尖头并且通过该器械的对置尖头被返回至发生机构。
当前，许多现代医用器械采用了集成电路，并且重要的是它们被正确绝缘。如果金属部件未被正确绝缘，则外科医生和患者电击受伤的危险可能极高。
背景技术
专利文献WO 93/20747描述了一种用于支持单极电弧放电以切割组织和消融梗塞的导丝，其包括柔软金属丝(其是不锈金属或合金如不锈钢)，金属丝包括远端、沿导丝延伸的电绝缘涂层和带有远端且连接至金属丝的电热绝缘尖头，该金属丝穿过电热绝缘尖头并且在金属丝和尖头的远端形成电极。根据WO 93/20747，该绝缘涂层必须是医学相容的电绝缘体例如聚氨酯、聚酰亚胺、聚乙烯和优选是聚四氟乙烯(特氟龙)，因为其具有出色的滑动性能。另外，绝缘涂层必须足够厚以保护使用导丝的手术医生和患者不会被电击并且同时足够薄以使绝缘丝插入细小体腔内。
专利文献EP1905370披露了一种电外科器械，确切说，披露了用于电外科器械的涂层，该电外科器械利用发热能量来烧灼、凝结和组织结合/熔合，与U形钉结合来形成止血钉/凝结/切割线组织。根据EP1905370，该电外科器械具有末端执行器，其可以具有第一极电极和第二极电极以及其中有至少一个U形钉的钉盒，视末端执行器所接受的能量类型而定。但是，在所有情况下，该电外科器械包括非导电涂层或者介电涂层，其可以视器械结构类型而定地被安置在：
-第二极电极的至少一部分上，或者
-第一和第二极电极中的至少一个上，在这里，介电涂层能防止组织直接接触电活电极中的至少一个，或者
-该钉盒的至少一个U形钉上，以减少在施加双极能量给组织时在其上形成表面电荷。
根据EP1905370的非导电涂层或介电涂层可以但不限于是聚四氟乙烯 (PTFE)、二氧化钛或基于对位二甲苯的聚合物或环氧树脂。
另外，从现有技术中知道了，当前一些电外科器械例如双极电外科手术剪被涂覆有通过热喷涂技术来沉积的Al2O3涂层。但是，这种实践可能复杂且很昂贵。
发明目的
本发明的目的是提供一种涂层体系和一种制造绝缘涂层的方法，该绝缘涂层最好同时显示出良好的耐磨性和/或良好的滑动性能。另外，本发明的目的是提供一种有利的制造根据本发明的涂层体系的方法，其允许以不复杂且不昂贵的方式涂覆具有不同形状尺寸的电外科器械部件。
发明描述
本发明的目的通过提供一种涂层体系来完成，该涂层体系包含至少一个二氧化锆层即ZrO2层，该层通过电弧蒸发PVD技术或者磁控溅射PVD技术来沉积。在利用磁控溅射PVD技术情况下，则优选高功率脉冲磁控溅射 (HIPIMS)技术。
根据本发明的含ZrO2的涂层体系可以被施加在需要电绝缘的医用器械如电外科器械例如单极和双极外科手术器械的部件的表面上。
根据本发明的含ZrO2的涂层体系对于给医用器械和仪器例如刀片、切割器和消融器以及双极器械和单极器械还有普通医用电子装置提供介电绝缘性是尤其理想的。
根据本发明的含ZrO2的涂层体系具有比热缩套管和聚合物包封模注更可靠的性能，因此最适用于涂覆电外科器械。
形成本发明涂层体系的、或者被包含在本发明涂层体系内的二氧化锆层最好显示出约为18.4的介电常数和/或约为0.60kV的高压击穿和/或约为 20mA的击穿电流。
根据本发明的含ZrO2的涂层体系的优选实施例包括至少一个氮化锆层。该氮化锆层最好作为夹层和/或支撑层沉积在该基材表面和二氧化锆层之间。
根据本发明的用于沉积二氧化锆层的优选方法牵涉到使用电弧蒸发技术来在反应性含氧气氛中蒸发“锆制的或主要含有锆的靶”(至少一个靶)以在基材表面形成二氧化锆。另外，最好至少在二氧化锆层的沉积过程中，对基材施以脉冲偏压。
根据本发明方法的上述实施例，通过反应电弧离子电镀PFV技术所沉积的二氧化锆层显示出至少主要或大部分含有锆的小滴。所述小滴是来自靶的熔化材料，其无法被正确蒸发并因此无法与反应气体(在此情况下是氧气)适当反应来形成期望的涂覆材料(在此情况下是ZrO2)。如此沉积的二氧化锆层显示出非常好的性能。
在包含至少一个电弧PVD沉积二氧化锆层的本发明涂层体系的优选实施例中，二氧化锆层的总厚度是不大于30μm的，或者是小于30μm的；最好是不大于20μm的，或是小于20μm的；更优选是不大于10μm，或小于 10μm。
必须如此选择用于本发明的涂层体系的电弧PVD沉积二氧化锆层的厚度，即，二氧化锆层能提供充分的绝缘作用。为此，需要考虑待涂覆表面的表面质量以及二氧化锆涂层的多孔性。
尤其是，在本文的语境下通过产生涂层体系获得了出色的结果，该涂层体系含有至少一个电弧PVD沉积二氧化锆层，其厚度为至少3μm，更尤其是至少4μm或5μm。
用于沉积本发明涂层体系的二氧化锆层的另一个优选方法牵涉以下的至少一个步骤，其中，通过使用在含氧气氛中的HIPIMS技术并通过施加脉冲偏压至在二氧化锆沉积过程中被涂覆的基材来溅射至少一个锆靶。
在如下内容中尤其提到了本发明涂层体系，其包括至少一个至少主要由 ZrO2构成的层，且被用于提供电绝缘性能给医用器械部件或者医用部件或仪器的至少一部分，所述医用部件或仪器可以是电外科器械或可以被包含在电外科器械内：一种具有电绝缘性能的涂层体系，其沉积在导电基材的表面上并且它必须是不导电的，所述导电基材作为医用器械、尤其是电外科器械的一部分，
所述涂层体系包括至少一个二氧化锆层，该二氧化锆层包含由锆构成的或者主要或大部分由锆构成的小滴。
根据一个优选的实施方式，该二氧化锆层显示出约为18.4的介电常数，和/或约0.60kV的高击穿电压和/或约20mA的击穿电流。
根据一个优选的实施方式，该二氧化锆层的厚度小于30μm，优选小于 20μm，更优选小于10μm，或在0.5μm至10μm之间。
根据一个优选的实施方式，该二氧化锆层的厚度至少是3μm，更尤其是至少4μm或5μm。
根据一个优选的实施方式，该涂层体系包括至少一个氮化锆层。
根据一个优选的实施方式，该氮化锆层作为夹层和/或支撑层沉积在该基材和该二氧化锆层之间。
根据一个优选的实施方式，涂覆表面是电极表面的至少一部分。
尤其是如下所提到地，本发明涂层体系可以被用于避免电击到在使用过程中接触医用器械的人员：
被涂覆的基材是金属丝，尤其是导丝。
尤其在如下内容提到了根据本发明的用于涂覆基材的方法：
根据一个优选的实施方式，该医用器械包括电极且优选是由金属丝以及至少一个尖头形成的电极，所述尖头附接至所述金属丝，该电极在该尖头处提供要与患者组织接触的接触面，并且该涂层体系被如此沉积在该电极的表面的至少一部分上，即被涂覆的电极表面的导电性被降低并且因此在该电极接触面处的热能也被减少以避免组织损伤。
该医用器械包括电极表面，其能接触患者身体或医用器械操作者的身体，并且该涂层体系被沉积在该表面的至少一部分上，以避免电击到患者或操作者。
根据一个优选的实施方式，在医用器械的表面上施加该涂层体系，以避免该医用器械在操作使用过程中短路。
根据一个优选的实施方式，该医用器械被用于切割组织和/或消融梗塞。

Claims (22)

1.一种具有电绝缘性能的涂层体系，其沉积在导电基材的表面上并且它必须是不导电的，所述导电基材作为医用器械的一部分，
其特征是，
所述涂层体系包括至少一个二氧化锆层，该二氧化锆层包含由锆构成的小滴，
其中，该二氧化锆层通过在含有氧气的气氛中电弧蒸发由锆构成的靶来沉积，至少在沉积该二氧化锆层过程中，将脉冲偏压施加到其表面正被涂覆的基材上，
其中，所述小滴是来自靶的熔化材料，其无法被正确蒸发并因此无法与反应气体氧气适当反应来形成期望的涂覆材料ZrO2，
其中，该二氧化锆层显示出为18.4的介电常数，和/或0.60kV的高击穿电压和/或20mA的击穿电流。
2.根据权利要求1的涂层体系，其特征是，该二氧化锆层的厚度小于30μm。
3.根据权利要求2的涂层体系，其特征是，该二氧化锆层的厚度小于20μm。
4.根据权利要求2的涂层体系，其特征是，该二氧化锆层的厚度小于10μm。
5.根据权利要求2的涂层体系，其特征是，该二氧化锆层的厚度在0.5μm至10μm之间。
6.根据权利要求2的涂层体系，其特征是，该二氧化锆层的厚度至少是3μm。
7.根据权利要求2的涂层体系，其特征是，该二氧化锆层的厚度至少是4μm。
8.根据权利要求2的涂层体系，其特征是，该二氧化锆层的厚度至少是5μm。
9.根据权利要求1至8之一的涂层体系，其特征是，该涂层体系包括至少一个氮化锆层。
10.根据权利要求9的涂层体系，其特征是，该氮化锆层作为夹层和/或支撑层沉积在该基材和该二氧化锆层之间。
11.根据权利要求1至8、10之一的涂层体系，其特征是，涂覆表面是电极表面的至少一部分。
12.根据权利要求1至8、10之一的涂层体系，其特征是，被涂覆的基材是金属丝。
13.根据权利要求12的涂层体系，其特征是，被涂覆的基材是导丝。
14.根据权利要求1至8、10、13之一的涂层体系，其特征是，所述导电基材作为电外科器械的一部分。
15.一种医用器械，其具有根据权利要求1至14之一的涂层体系，该医用器械是刀片或切割器或消融器或单极电外科器械或双极电外科器械。
16.根据权利要求15的医用器械，其特征是，该医用器械包括电极，所述电极由金属丝以及至少一个尖头形成的电极，所述尖头附接至所述金属丝，该电极在该尖头处提供要与患者组织接触的接触面，并且该涂层体系被如此沉积在该电极的表面的至少一部分上，即被涂覆的电极表面的导电性被降低并且因此在该电极接触面处的热能也被减少以避免组织损伤。
17.根据权利要求15的医用器械，其特征是，该医用器械包括电极表面，其能接触患者身体或医用器械操作者的身体，并且该涂层体系被沉积在该表面的至少一部分上，以避免电击到患者或操作者。
18.根据权利要求15的医用器械，其特征是，在医用器械的表面上施加该涂层体系，以避免该医用器械在操作使用过程中短路。
19.根据权利要求15至18之一的医用器械，其特征是，该医用器械被用于切割组织和/或消融梗塞。
20.一种用于形成根据权利要求1至14之一的涂层体系的或用于涂覆根据权利要求15至19之一的医用器械的方法，其特征是，至少该二氧化锆层通过物理气相沉积技术来沉积。
21.根据权利要求20的方法，其特征是，至少该二氧化锆层通过电弧PVD技术来沉积。
22.一种用于形成根据权利要求1至14之一的涂层体系的或用于涂覆根据权利要求15至19之一的医用器械的方法，其特征是，该涂层体系的沉积包括使用高功率脉冲磁控溅射技术来沉积至少一个层。
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