CN115120308A - 一种超声外科手术刀及其镀层加工方法 - Google Patents
一种超声外科手术刀及其镀层加工方法 Download PDFInfo
- Publication number
- CN115120308A CN115120308A CN202111432620.9A CN202111432620A CN115120308A CN 115120308 A CN115120308 A CN 115120308A CN 202111432620 A CN202111432620 A CN 202111432620A CN 115120308 A CN115120308 A CN 115120308A
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- Prior art keywords
- ultrasonic surgical
- material layer
- layer
- surgical blade
- coating
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
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Abstract
本申请涉及一种超声外科手术刀及其镀层加工方法,本申请通过在超声外科手术刀的凝血切割面上加工第一材料层,实现金属基材上涂布单层低摩擦系数的镀层。单层镀层可以把镀层厚度做得更薄,产品性能更佳,从而提升产品使用寿命。镀层附着力比涂层更佳,更不容易脱落,满足产品多次使用需求。
Description
技术领域
本发明涉及医疗设备领域,具体涉及一种超声外科手术刀及其镀层加工方法。
背景技术
超声刀是进行超声治疗的必要工具。超声刀的应用原理是通过换能器将电能转化为机械振动,并将振动通过导杆传递至刀头,使刀头产生机械性振荡,对动物或人体组织起到切割和凝血的作用。超声刀由于具有切割精度高、出血少以及热损伤小等优点,被广泛应用在外科手术中。传统技术方案中,对于超声刀的刀头有以下三种处理方案:1、刀头表面喷砂,无涂层;2、刀头表面有两层表面涂层或涂层与镀层的组合;3、刀头表面仅有一层单层涂层。
其中,方案2中超声刀刀头表面采用二层涂层的原因,是单层低摩擦系数的非金属涂层无法通过喷涂直接有效附着在超声刀本身的金属基材上,需要通过镀层才能实现有效附着。而方案3中的单层涂层制备,则需要经过多次复杂工艺处理,技术难度大、成本高。在实际的超声刀使用过程中,为了满足超声刀耐磨要求,涂层一般都设计的较厚,较厚的涂层增加了超声刀阻抗,刀头的全区域涂层结构也会进一步导致阻抗上升,最终超声刀会由于换能器产生热量过大,导致出现产品可靠性低、治疗效果不佳等问题。
发明内容
本申请通过提供一种新的超声外科手术刀及其镀层加工方法。
基于上述目的,本申请一种实施例中提供一种超声外科手术刀,包括直接作用于组织对象的刀尖,和用于将振动传递至所述刀尖的波导杆,所述刀尖包括:
主体,所述主体由金属材料制成,其具有近端和远端;所述主体在近端处与所述波导杆相连接,并沿纵向背离所述波导杆弯曲延伸至所述远端;所述主体接收从所述波导杆传递过来的超声振动,以使得所述主体能够基于接收到的超声振动对所述组织对象进行操作处理,所述主体上设置有凝血切割面;
以及形成在所述主体的凝血切割面上的第一材料层,所述第一材料层的表面能低于所述主体表面的表面能。
一种实施例中,所述第一材料层为将第一材料以真空镀膜工艺加工在所述凝血切割面上的镀层。
一种实施例中,所述第一材料为聚合材料或者含聚合物的材料。
一种实施例中,所述第一材料层的厚度a的取值范围为:5纳米≤a≤0.3毫米。
一种实施例中,所述第一材料层的厚度a的取值范围为:5微米≤a≤8微米。
一种实施例中,所述主体还包括与所述凝血切割面连接的辅助面以及形成在所述辅助面上的第二材料层,所述第二材料层为将第二材料以真空镀膜工艺加工在所述辅助面上的镀层。
一种实施例中,所述第二材料层的厚度小于所述第一材料层的厚度。
一种实施例中,所述第二材料层的厚度b的取值范围为:1纳米≤b≤0.3毫米。
一种实施例中,所述第二材料层的厚度b的取值范围为:1微米≤b≤2微米。
一种实施例中,所述第二材料层与所述第一材料层的材料相同或不同。
一种实施例中,所述第二材料为非金属材料。
一种实施例中,所述第二材料为聚合材料或者含聚合物的材料。
一种实施例中,所述第一材料层与所述第二材料层不重叠、部分重叠或全部重叠。
一种实施例中,所述第一材料层或所述第二材料层的全部或者部分导电。
一种实施例中,所述刀尖主体上设置有背切部,所述凝血切割面与所述背切部对称或近似对称地设置于所述刀尖沿纵向方向的中轴的两侧;
其中,设置于所述凝血切割面上的第一材料层或第二材料层不导电,设置于所述背切部或除所述凝血切割面、背切部以外区域的第一材料层或第二材料层导电或不导电。
一种实施例中,所述第二材料层的表面能大于所述第一材料层的表面能且小于所述主体的表面能,所述第二材料层的硬度大于所述第一材料层。
一种实施例中,所述第一材料层或第二材料层以真空镀膜工艺加工在所述凝血切割面上的镀层,其特征在于,所述真空镀膜工艺包括:
前处理:对经表面处理后的目标区域进行表面前处理,以增加所述目标区域的表面粗糙度、与待镀材料的结合面积和表面能中的至少一项参数;
镀层:将待镀材料镀在目标区域上。
一种实施例中,所述前处理采用表面等离子处理工艺。
一种实施例中,所述真空镀膜工艺中,在所述前处理之前进行表面处理,所述表面处理包括对所述目标区域进行表面处理,以提高目标区域的附着力。
一种实施例中,所述镀层步骤采用物理气相沉积、化学气相沉积或厚膜高速氧焰等离子体材料施加技术。
一种实施例中,所述第一材料和第二材料均分别为四氟化碳、六氟乙烷、六氟丙烷、七氟丙烷、八氟丙烷、全氟丁烷、全氟戊烷、十氟戊烷、全氟己烷、四氟乙烯和六氟丙烯的共聚物、陶瓷复合物、聚四氟乙烯、陶瓷复合物、聚丙烯、聚乙烯、聚己酸内酯、二硫化钨、二硫化钼、石墨、氧化铝、氧化钨、氮化钛、氮化铬、碳化铬、碳化钨和金属化陶瓷中的一种或多种的组合。
基于上述目的,本申请一种实施例中提供一种适用于超声外科手术刀的镀层加工方法,包括:
前处理:对超声刀头的目标区域进行表面前处理,以增加所述目标区域的表面粗糙度、与待镀材料的结合面积和表面能中的至少一项参数;
镀层:将待镀材料镀在目标区域上。
一种实施例中,所述前处理采用表面等离子处理工艺。
一种实施例中,所述镀层加工方法中,在所述前处理之前进行表面处理,所述表面处理包括对所述目标区域进行表面处理,以提高目标区域的附着力。
一种实施例中,所述镀层步骤采用物理气相沉积、化学气相沉积或厚膜高速氧焰等离子体材料施加技术。
一种实施例中,所述目标区域包括超声刀头上用于实现凝血、切割功能的凝血切割面和连接所述凝血切割面的辅助面,所述待镀材料包括第一材料和第二材料,在所述镀层步骤中,所述第一材料被加工在凝血切割面上并形成第一材料层,所述第二材料被加工在辅助面上并形成第二材料层,所述第一材料层厚度大于所述第二材料层厚度。
一种实施例中,所述第一材料和第二材料均分别为四氟化碳、六氟乙烷、六氟丙烷、七氟丙烷、八氟丙烷、全氟丁烷、全氟戊烷、十氟戊烷、全氟己烷、四氟乙烯和六氟丙烯的共聚物、陶瓷复合物、聚四氟乙烯、陶瓷复合物、聚丙烯、聚乙烯、聚己酸内酯、二硫化钨、二硫化钼、石墨、氧化铝、氧化钨、氮化钛、氮化铬、碳化铬、碳化钨和金属化陶瓷中的一种或多种的组合。
可以看出,本申请通过在超声外科手术刀的凝血切割面上加工第一材料层,实现金属基材上涂布单层低摩擦系数的镀层。单层镀层可以把镀层厚度做得更薄,产品性能更佳,从而提升产品使用寿命。镀层附着力比涂层更佳,更不容易脱落,满足产品多次使用需求。
进一步地,一些实施例中,针对不同的功能区域,镀层厚度和材料可相同或不同,如凝血切割面,需要耐磨,镀层厚度增加,而两侧辅助面,镀层厚度则可以相对较薄,这样刀杆的阻抗可以在满足产品功能性能下做到更低。
附图说明
图1为本申请的超声手术器械中超声外科手术刀的刀尖结构示意图;
图2为本申请的超声手术器械中波导杆与刀尖的结构示意图;
图3为本申请的超声手术器械中刀柄与波导杆、刀尖连接的结构示意图;
图4为本申请的超声手术器械中刀柄、换能器的连接示意图;
图5为本申请的超声手术器械中超声刀系统的结构示意图。
具体实施方式
下面通过具体实施方式结合附图对本发明作进一步详细说明。其中不同实施方式中类似元件采用了相关联的类似的元件标号。在以下的实施方式中,很多细节描述是为了使得本申请能被更好的理解。然而,本领域技术人员可以毫不费力的认识到,其中部分特征在不同情况下是可以省略的,或者可以由其他元件、材料、方法所替代。在某些情况下,本申请相关的一些操作并没有在说明书中显示或者描述,这是为了避免本申请的核心部分被过多的描述所淹没,而对于本领域技术人员而言,详细描述这些相关操作并不是必要的,他们根据说明书中的描述以及本领域的一般技术知识即可完整了解相关操作。
另外,说明书中所描述的特点、操作或者特征可以以任意适当的方式结合形成各种实施方式。同时,方法描述中的各步骤或者动作也可以按照本领域技术人员所能显而易见的方式进行顺序调换或调整。因此,说明书和附图中的各种顺序只是为了清楚描述某一个实施例,并不意味着是必须的顺序,除非另有说明其中某个顺序是必须遵循的。
本文中为部件所编序号本身,例如“第一”、“第二”等,仅用于区分所描述的对象,不具有任何顺序或技术含义。而本申请所说“连接”、“联接”,如无特别说明,均包括直接和间接连接(联接)。
实施例一
本实施例提供了一种超声手术器械,具体地,图1为本申请实施例中一个具体的超声外科手术刀的刀尖结构示意图,其包括主体,主体包括凝血切割面1、辅助面2、凝血切割部3。其中,凝血切割面1与辅助面2上可以进行镀层设置。图中用不同颜色示出了凝血切割面1、辅助面2的区域。
在一个具体的实施例中,通过真空镀膜工艺,一次加工成型,实现了金属基材上涂布单层低摩擦系数的非金属镀层。单层镀层可以把镀层厚度做得更薄,产品性能更佳,从而提升产品使用寿命。镀层附着力比涂层更佳,更不容易脱落,满足产品多次使用需求。在另一个实施例中,针对不同的功能区域(如凝血切割面1和辅助面2),镀层厚度不同/材料也可以不同。如组织凝血切割表面部,需要耐磨功能,镀层厚度则增加,而两侧辅助面2,镀层厚度则可以相对较薄,这样刀杆的阻抗可以在满足产品功能性能下做到最低。优选的,本方案的各实施例中,至少有一层镀层。
如图1所示,在刀尖上,凝血切割面1上设有镀层结构。在另一个实施例中,基于辅助面2的功能,可以不设置镀层或者设置厚度较薄(小于凝血切割面1上镀层厚度)的镀层,镀层的材料也不限于与凝血切割面1完全相同。在另一个实施例中,手术过程中直接进行组织处理的面结构为手术需求面,如凝血切割面1和辅助面2,其上都设置有相同材质、相同厚度的镀层。
针对不同的功能区域,镀层厚度不同/材料也可以不同,如凝血切割面1,需要耐磨,镀层厚度增加,而两侧辅助面2,镀层厚度则可以相对较薄,这样刀杆的阻抗可以在满足产品功能性能下做到最低。
在一个优选的实施例中,镀层与镀层之间可以重叠,例如基于已经完成第一材料层布置的超声刀头,继续在其上的辅助面2上布置第二材料层,或者是进一步对凝血切割面1进行处理。
进一步地,对于经过上述处理的超声刀头,本实施例进一步对其进行了阻抗测试,测试结果如下:
进一步地,可以采用下列工艺制备获得前述各实施例中的超声刀头。
表面处理工艺:喷丸、喷砂、滚花、雕刻、蚀刻、激光雕刻、等离子蚀刻、电晕放点蚀刻、抛光、磨粒流加工和其它技术。优先的选取喷丸、喷砂技术。
前处理工艺:使用无机含氧气体或含烃基气体或混合体进行表面等离子处理。无机含氧气体(但不限于)包括水、过氧化氢、臭氧、氧气、二氧化碳、二氧化氮、一氧化氮中的至少一种。含烃基气体(但不限于)包括直链烃、环氧烃、芳烃、醇、羧酸、醚、呋喃、有机胺中的至少一种。
镀层施工:涂布、浸渍、喷涂、刷涂、干燥、熔化、激光固化、UV固化、阳极氧化、电镀、化学沉积、物理气相沉积(PVD)、化学气相沉积(CVD)、热喷涂、厚膜高速氧焰等离子体和其它合适的材料施加技术。优先的选取喷涂、物理气相沉积。(PVD)、化学气相沉积(CVD)技术。各镀层可以通过一次也可以多次施工完成。
镀层施工范围:包括但并不限制于刀头凝血切割段,在一个具体的实施例中,只针对凝血切割段进行镀层处理,能有效保证手术过程中防止刀头与组织黏连。对其他部位进行镀层处理,则可以基于超声刀头的具体工作需求进行设置,本实施例中对此不作具体的限制。
镀层或镀层厚度:镀层的厚度范围为5纳米~0.3毫米,根据具体需求,不同的区域可以施加不同的镀层厚度。在一个具体的实施例中,凝血切割面1需要耐磨,镀层厚度最厚,优选5-8μm,而两侧辅助面2无需耐磨要求,镀层厚度可以较薄,优选1-2μm。
镀层或镀层材料:本实施例中,第一材料、第二材料可以是聚合材料或者含聚合物的材料,例如(但不限于)包括括四氟化碳、六氟乙烷、六氟丙烷、七氟丙烷、八氟丙烷、全氟丁烷、全氟戊烷、十氟戊烷、全氟己烷、四氟乙烯(TFE)和六氟丙烯(HFP)的共聚物(FEP)、FEP/陶瓷复合物、聚四氟乙烯(PTFE)、PTFE/陶瓷复合物、聚丙烯、聚乙烯、聚己酸内酯、;非聚合物,例如(但不限于)二硫化钨、二硫化钼、石墨、氧化铝、氧化钨、氮化钛、氮化铬、碳化铬、碳化钨、金属化陶瓷、不锈钢、钼;其他材料还有硅胶、无机聚硅氮烷、有机聚硅氮烷、改性无机聚硅氮烷和改性有机聚硅氮烷等。本实施例的镀层可以由以上一种或多种组合形成。优先的选取聚四氟乙烯(PTFE)、PTFE/陶瓷复合物、氮化铬镀层、有机聚硅氮烷。即,本实施例的第一材料、第二材料,分别可以是上述聚合材料或者含聚合物的材料中的一种,或者多种的组合,本实施例中对此不作具体的限定。
实施例二
本实施例提供了一种超声外科手术刀,该超声刀头可作为超声手术器械的一种。请参考图1和2,该超声外科手术刀包括直接作用于组织对象的刀尖100和用于将振动传递至刀尖100的波导杆200。该刀尖100包括主体,主体由金属材料制成,其具有近端和远端。主体在近端处与波导杆200相连接,并沿纵向背离波导杆200弯曲延伸至远端。主体接收从波导杆200传递过来的超声振动,以使得主体能够基于接收到的超声振动对组织对象进行操作处理。该刀尖100的主体具有凝血切割部3,该凝血切割部3具有用于实现凝血、切割功能的凝血切割面1和连接凝血切割面1的辅助面2。该刀尖100还可能具有与凝血切割面1相背离的背切部5,以便增加切割的灵活性。图中用不同灰度示出了凝血切割面1、辅助面2的区域。
其中,考虑到凝血切割面1经常与处理对象进行接触和摩擦,为了满足该凝血切割面1的耐磨要求,该凝血切割面1上设有第一材料层,该第一材料层的表面能低于主体表面的表面能。
进一步地,一种实施例中,为了降低第一材料层对刀尖100阻抗的影响,该第一材料层为将第一材料加工在凝血切割面1上的镀层。
具体来说,在传统的涂层工艺中,其通过底涂胶水使表面涂层跟刀尖100的金属基材进行结合,胶水结合力一般都不大,特别是摩擦系数小的涂层,如氟涂层,所以结合力都比较差,涂层和基材之间的原子距离也不密实,所以容易脱落。因此,往往需要在刀尖100的金属基材上先设置一层打底涂层,然后再将耐磨性更高的涂层涂覆在该打底涂层上,这导致了刀尖100外侧的涂层过厚,使得刀尖100的阻抗急剧增加,进而导致换能器发热大,降低产品可靠性。相比之下,本实施例中第一材料为在凝血切割面1上的镀层,该镀层能够与凝血切割面1更牢固的附着,无需设置打底涂层,进而能够更灵活的选择镀层的厚度,以在满足耐磨要求的前提下,降低刀尖100的阻抗,提高刀尖100的可靠性。
此外,本实施例中至少保证凝血切割面1上设有镀层,而其他区域,例如辅助面2和背切部5等,可根据实际场景需求而决定是否设置镀层。相比整个刀尖100外壁均设有涂层的现有技术来说,当辅助面2或背切部这些区域不设置镀层或设置更薄的镀层时,还可以进一步的降低这些区域的阻抗,进一步提高刀尖100的可靠性。而且,该第一材料层的表面能低于主体表面的表面能,从而使凝血切割面1相对主体表面(如直接裸露在外的主体表面)更不容易粘连人体组织,防止刀尖100挂连人体组织。
在采用第一材料形成的镀层作为耐磨层时,可将第一材料层的厚度a的取值范围设置为:5纳米≤a≤0.3毫米,该取值范围既可以保证凝血切割面1满足耐磨要求,又可以将凝血切割面1这一区域的阻抗控制在较小的范围,利于保证刀尖100的可靠性。
在上述a的取值范围中,不同的小范围之间也存在差异,一种实施例中,将第一材料层的厚度a的取值范围设置为:5微米≤a≤8微米。该更小范围下,能够在满足耐磨要求和阻抗控制两方面获得一个较好的平衡,从而产生一个相比之下更好的最终效果,更利于保证刀尖100的可靠性。
进一步地,如前文所述,除凝血切割面1之外,该刀尖100的其他区域也可设置或不设置保护层。本申请一种实施例中,该辅助面2上设有第二材料层,与第一材料层思路类似,区别于现有技术中的涂层,本实施例中第二材料层为将第二材料加工在辅助面2上的镀层。该镀层能够与辅助面2更牢固的附着,无需设置打底涂层,进而能够更灵活的选择镀层的厚度,以在满足耐磨要求的前提下,降低刀尖100的阻抗,提高刀尖100的可靠性。
其中,该第一材料和第二材料可采用相同或不同的材料。例如,为了降低加工成本,可同时在凝血切割面1和辅助面2上设置相同材料的镀层,进而形成第一材料层和第二材料层。不过,因为凝血切割面1和辅助面2对耐磨性的要求不同,其中辅助面2对耐磨性的要求低于凝血切割面1,因此也可以分别在凝血切割面1和辅助面2上分别设置不同材料的镀层,来形成第一材料层和第二材料层。如此,增加了第一材料层和第二材料层选择的多样性,凝血切割面1和辅助面2可根据实际需求来选择最合适的材料。
其中,该第一材料层和第二材料层各自区域可严格的区分开,也可以相互连为一体。一些实施例中,第一材料层与第二材料层不重叠、部分重叠或全部重叠。例如,第二材料层可覆盖一部分或全部第一材料层,或者第一材料层可覆盖一部分或全部第二材料层。
一种实施例中,该第二材料层的表面能高于第一材料层且低于主体的表面,第二材料层的耐磨性高于第一材料,第二材料层的硬度大于第一材料层。
此外,考虑到辅助面2对耐磨性的要求低于凝血切割面1,也可以将第二材料层的厚度设置为小于第一材料层的厚度。随着第二材料层的厚度的降低,能够进一步降低刀尖100的阻抗,进一步提高产品的可靠性。
例如,在采用第二材料形成的镀层作为耐磨层时,一种实施例中,可将第二材料层的厚度b的取值范围为:1纳米≤b≤0.3毫米。较好地,一种实施例中,第二材料层的厚度b的取值范围为:1微米≤b≤2微米。
对此,本实施例还提供了一些实验数据供参考,案例如下:
根据以上表格可见,在保证第一材料层具有同等耐磨性能(如第一材料层的厚度取值保持在5-8μm(微米)之间)时,当第二材料层厚度小于第一材料层厚度,样品阻抗有明显的降低。
当然,基于其他需求,某些实施例中也可将第二材料层的厚度设置为等于或大于第一材料层的厚度。
进一步地,一种实施例中,该第一材料层或第二材料层的全部或者部分导电,以满足对应的导电需求。
一种实施例中,当刀尖100的主体上设置有背切部5,该凝血切割面1和背切部5对称或近似对称地设置于刀尖100沿纵向方向的中轴的两侧;其中,设置于凝血切割面1上的第一材料层或第二材料层不导电,设置于背切部5或除凝血切割面1、背切部5以外区域的第一材料层或第二材料层导电或不导电,以满足对应的导电需求。
进一步地,为了使第一材料层和第二材料层与刀尖100之间具有更好的附着力,一种实施例中,将第一材料和/或第二材料成型于凝血切割面1上的工艺为真空镀膜工艺。真空镀层工艺能够在真空下离子化而再进行正负离子结合形成结合力很强的化学键,涂层离子化成为原子微粒,通过电场冲击到金属基材上,堆积很密实,所以结合力很强。
进一步地,通常刀尖100采用金属材料制成,综合加工工艺、耐磨性能以及成本的因素的考虑,一种实施例中,该第一材料和/或第二材料为非金属材料。
尤其是一种实施例中,该第一材料和/或第二材料为聚合材料或者含聚合物的材料。该聚合材料和含聚合物的材料,例如(但不限于)包括括四氟化碳、六氟乙烷、六氟丙烷、七氟丙烷、八氟丙烷、全氟丁烷、全氟戊烷、十氟戊烷、全氟己烷、四氟乙烯(TFE)和六氟丙烯(HFP)的共聚物(FEP)、FEP/陶瓷复合物、聚四氟乙烯(PTFE)、PTFE/陶瓷复合物、聚丙烯、聚乙烯、聚己酸内酯。非聚合物,例如(但不限于)二硫化钨、二硫化钼、石墨、氧化铝、氧化钨、氮化钛、氮化铬、碳化铬、碳化钨、金属化陶瓷。一种实施例中,该第一材料和/或第二材料还可以选择硅胶、无机聚硅氮烷、有机聚硅氮烷、改性无机聚硅氮烷和改性有机聚硅氮烷。其中,该第一材料和/或第二材料可以由以上一种或多种组合形成。一些实施例中,可优先选取聚四氟乙烯(PTFE)、PTFE/陶瓷复合物、氮化铬涂层、有机聚硅氮烷。
进一步地,本实施例还提供了一种具体完成镀层操作的真空镀膜工艺,该包括:
表面处理:对目标区域进行表面处理,以提高目标区域的附着力;
具体地,利用喷丸、喷砂、滚花、雕刻、蚀刻、激光雕刻、等离子蚀刻、电晕放点蚀刻、抛光、磨粒流加工或其它技术对目标区域进行表面处理。
一种实施例中,可优先的选取抛光、喷丸、喷砂技术。
当然,某些实施例中,该真空镀膜工艺也可省略表面处理这一步骤。
前处理:对经表面处理后的目标区域进行表面前处理,以增加目标区域的表面粗糙度、与待镀材料的结合面积和表面能中的至少一项参数,以使目标区域更容易与待镀材料进行结合。
一种实施例中,该前处理采用表面等离子处理工艺;
具体地,一种实施例中,可使用无机含氧气体或含烃基气体或混合体进行表面等离子处理。无机含氧气体(但不限于)包括水、过氧化氢、臭氧、氧气、二氧化碳、二氧化氮、一氧化氮中的至少一种。含烃基气体(但不限于)包括直链烃、环氧烃、芳烃、醇、羧酸、醚、呋喃、有机胺中的至少一种。金属基材离子化后,跟离子化镀层分子结合形成化学键,增强镀层和金属基材的结合力。
镀层:将待镀材料镀在目标区域上。
具体地,采用物理气相沉积(PVD)、化学气相沉积(CVD)、厚膜高速氧焰等离子体和其它合适的材料施加技术。一些实施例中,可优先选取物理气相沉积(PVD)、化学气相沉积(CVD)技术。此外,该镀层可以通过一次加工而成,也可以多次加工完成。
在上述真空镀膜工艺中,目标区域为刀尖100上需要设置镀层的区域,一种实施例中,该目标区域至少包括凝血切割面1,在其他实施例中,目标区域也可以包括辅助面2和/或背切部5。
在上述真空镀膜工艺中,视需要设置镀层的区域不同,该待镀材料可以为第一材料和/或第二材料。
进一步地,请参考图2,一种实施例中还提供了一种超声外科手术刀,其包括刀尖100和波导杆200,刀尖100设置于波导杆200的一端。其中,该刀尖100为如实施例一所示的刀尖或实施例二所示的刀尖。
该刀尖100可与波导杆200一体成型,或分开制造后固定连接,以传递振动。
请参考图3,一种实施例中还提供了一种超声外科手术刀的刀柄1000的结构,该刀柄1000包括用于与如上述任一项实施例所示的刀尖100连接的夹持组件300,该刀尖100通过波导杆200安装在夹持组件300上。该夹持组件300可控制一个夹片400与刀尖100进行配合,以夹紧和松开目标物体。
请参考图4,一种实施例中还提供了一种超声外科手术刀,其包括如上述实施例所示的刀柄1000以及换能器2000,该换能器2000与刀柄1000连接,换能器2000能够将电信号转成机械振动,其所产生的振动可传递至刀柄1000上,尤其是传递至刀柄1000连接的波导杆200和刀尖100上。
请参考图5,一种实施例中还提供了一种超声刀系统,其包括如上述实施例所示的超声外科手术刀以及主机3000,该主机3000与超声外科手术刀的换能器2000信号连接,以控制换能器2000工作,产生机械振动。同时,该主机3000也可用来接收来自手术对象的信号反馈并进行相关分析。
以上应用了具体个例对本发明进行阐述,只是用于帮助理解本发明,并不用以限制本发明。对于本发明所属技术领域的技术人员,依据本发明的思想,还可以做出若干简单推演、变形或替换。
Claims (27)
1.一种超声外科手术刀,包括直接作用于组织对象的刀尖和用于将振动传递至所述刀尖的波导杆,其特征在于,所述刀尖包括:
主体,所述主体由金属材料制成,其具有近端和远端;所述主体在近端处与所述波导杆相连接,并沿纵向背离所述波导杆弯曲延伸至所述远端;所述主体接收从所述波导杆传递过来的超声振动,以使得所述主体能够基于接收到的超声振动对所述组织对象进行操作处理,所述主体上设置有凝血切割面;
以及形成在所述主体的凝血切割面上的第一材料层,所述第一材料层的表面能低于所述主体表面的表面能。
2.根据权利要求1所述的超声外科手术刀,其特征在于,所述第一材料层为将第一材料以真空镀膜工艺加工在所述凝血切割面上的镀层。
3.根据权利要求2所述的超声外科手术刀,其特征在于,所述第一材料为聚合材料或者含聚合物的材料。
4.根据权利要求1-3任一项所述的超声外科手术刀,其特征在于,所述第一材料层的厚度a的取值范围为:5纳米≤a≤0.3毫米。
5.根据权利要求4所述的超声外科手术刀,其特征在于,所述第一材料层的厚度a的取值范围为:5微米≤a≤8微米。
6.根据权利要求1-5任一项所述的超声外科手术刀,其特征在于,所述主体还包括与所述凝血切割面连接的辅助面以及形成在所述辅助面上的第二材料层,所述第二材料层为将第二材料以真空镀膜工艺加工在所述辅助面上的镀层。
7.根据权利要求6所述的超声外科手术刀,其特征在于,所述第二材料层的厚度小于所述第一材料层的厚度。
8.根据权利要求6或7所述的超声外科手术刀,其特征在于,所述第二材料层的厚度b的取值范围为:1纳米≤b≤0.3毫米。
9.根据权利要求8所述的超声外科手术刀,其特征在于,所述第二材料层的厚度b的取值范围为:1微米≤b≤2微米。
10.根据权利要求6-9任一项所述的超声外科手术刀,其特征在于,所述第二材料层与所述第一材料层的材料相同或不同。
11.根据权利要求6-9任一项所述的超声外科手术刀,其特征在于,所述第二材料为非金属材料。
12.根据权利要求11所述的超声外科手术刀,其特征在于,所述第二材料为聚合材料或者含聚合物的材料。
13.根据权利要求6-12任一项所述的超声外科手术刀,其特征在于,所述第一材料层与所述第二材料层不重叠、部分重叠或全部重叠。
14.根据权利要求13所述的超声外科手术刀,其特征在于,所述第一材料层或所述第二材料层的全部或者部分导电。
15.根据权利要求14所述的超声外科手术刀,其特征在于,所述刀尖的主体上设置有背切部,所述凝血切割面与所述背切部对称或近似对称地设置于所述刀尖沿纵向方向的中轴的两侧;
其中,设置于所述凝血切割面上的第一材料层或第二材料层不导电,设置于所述背切部或除所述凝血切割面、背切部以外区域的第一材料层或第二材料层导电或不导电。
16.根据权利要求6-15任一项所述的超声外科手术刀,其特征在于,所述第二材料层的表面能大于所述第一材料层的表面能且小于所述主体的表面能,所述第二材料层的硬度大于所述第一材料层。
17.根据权利要求1或16所述的超声外科手术刀,所述第一材料层或第二材料层以真空镀膜工艺加工在所述凝血切割面上的镀层,其特征在于,所述真空镀膜工艺包括:
前处理:对经表面处理后的目标区域进行表面前处理,以增加所述目标区域的表面粗糙度、与待镀材料的结合面积和表面能中的至少一项参数;
镀层:将待镀材料镀在目标区域上。
18.根据权利要求17所述的超声外科手术刀,其特征在于,所述前处理采用表面等离子处理工艺。
19.根据权利要求17所述的超声外科手术刀,其特征在于,所述真空镀膜工艺中,在所述前处理之前进行表面处理,所述表面处理包括对所述目标区域进行表面处理,以提高目标区域的附着力。
20.根据权利要求17所述的超声外科手术刀,其特征在于,所述镀层步骤采用物理气相沉积、化学气相沉积或厚膜高速氧焰等离子体材料施加技术。
21.根据权利要求6-20任一项所述的超声外科手术刀,其特征在于,所述第一材料和第二材料均分别为四氟化碳、六氟乙烷、六氟丙烷、七氟丙烷、八氟丙烷、全氟丁烷、全氟戊烷、十氟戊烷、全氟己烷、四氟乙烯和六氟丙烯的共聚物、陶瓷复合物、聚四氟乙烯、陶瓷复合物、聚丙烯、聚乙烯、聚己酸内酯、二硫化钨、二硫化钼、石墨、氧化铝、氧化钨、氮化钛、氮化铬、碳化铬、碳化钨和金属化陶瓷中的一种或多种的组合。
22.一种适用于超声外科手术刀的镀层加工方法,其特征在于,包括:
前处理:对超声刀头的目标区域进行表面前处理,以增加所述目标区域的表面粗糙度、与待镀材料的结合面积和表面能中的至少一项参数;
镀层:将待镀材料镀在目标区域上。
23.根据权利要求22所述的镀层加工方法,其特征在于,所述前处理采用表面等离子处理工艺。
24.根据权利要求22所述的镀层加工方法,其特征在于,所述镀层加工方法中,在所述前处理之前进行表面处理,所述表面处理包括对所述目标区域进行表面处理,以提高目标区域的附着力。
25.根据权利要求22所述的镀层加工方法,其特征在于,所述镀层步骤采用物理气相沉积、化学气相沉积或厚膜高速氧焰等离子体材料施加技术。
26.根据权利要求22-25任一项所述的镀层加工方法,其特征在于,所述目标区域包括超声刀头上用于实现凝血、切割功能的凝血切割面和连接所述凝血切割面的辅助面,所述待镀材料包括第一材料和第二材料,在所述镀层步骤中,所述第一材料被加工在凝血切割面上并形成第一材料层,所述第二材料被加工在辅助面上并形成第二材料层,所述第一材料层厚度大于所述第二材料层厚度。
27.根据权利要26所述的镀层加工方法,其特征在于,所述第一材料和第二材料均分别为四氟化碳、六氟乙烷、六氟丙烷、七氟丙烷、八氟丙烷、全氟丁烷、全氟戊烷、十氟戊烷、全氟己烷、四氟乙烯和六氟丙烯的共聚物、陶瓷复合物、聚四氟乙烯、陶瓷复合物、聚丙烯、聚乙烯、聚己酸内酯、二硫化钨、二硫化钼、石墨、氧化铝、氧化钨、氮化钛、氮化铬、碳化铬、碳化钨和金属化陶瓷中的一种或多种的组合。
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