CN1145024A - 绝缘的器具 - Google Patents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A61B18/1482—Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
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- A61B2018/00053—Mechanical features of the instrument of device
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Abstract
一种器械,其中在外表面上设有两种不同材料的涂层。选择其中第一层来提供至少覆盖在器械的基面上的绝缘层,而第二层用来提供该绝缘层的可能的剩余使用寿命的标志。选择两个涂层之间的相关特征,这样当第二涂层的可见的外观逐渐达到一预定的极限时,第一涂层的绝缘性能将仍能令人满意,只是表明器械已经达到其使用寿命的终了的那一点,因而提供一备用的和无源直观观察该器械应当更换的时间标志。
Description
发明领域
本发明涉及一种绝缘涂层,尤其涉及可用肉眼监控以保证绝缘完整性操作的绝缘涂层;特别是可重复使用的电外科用的电极。
发明背景
由于技术进步,已出现日渐增加的需要在器具和其它产品表面上施以绝缘涂层的应用场合。因此,诸如在医疗领域中,已经有日渐增多的器具在其某些表面上需要施以绝缘涂层。这些包括、然而并不仅限于用于进行腹腔镜检和非腹腔镜检两种手术的先进的器具。
如本技术领域中那些熟练人员所知,由于外科知识和技术的进步,已经有相应的趋势朝着使外科手术的切口和进入器械的尺寸减小的方向发展,由此而减小病人的伤口以便尽快使病人恢复。这已引起对采用医疗用小电极的腹腔镜检法和其它外科手术的实践。爱滋病(AIDS)和其它高危或致命的传染性疾病使采用抛弃型器件或经过彻底消毒的可重复使用的器件的重要性更为突出。虽然彻底消毒对于某些器具来说可能是较经济和低成本的,然而其中也存在其它的缺点,即消毒时苛刻的设施(例如:用高压锅蒸煮消毒)可能是极其有害的或者导致使用寿命缩短。而且,对于一些器具来说,重复使用本身也可能导致磨损或损耗。这些顾虑同样也适用于腹腔镜检法和非腹腔镜检法的设施。在防治传染性疾病时,到目前为止已提出了多种电外科技术和器具,它们的示例描述在1933年7月4日授予F.M.Ende的美国专利第1,916,722号;1974年9月19日授予Bernard Weissman等人的德国专利第2,404,764号;1982年1月25日由William S.Walker递交的PCT国际申请第US82/0084号;以及1991年8月2日由Edwin Langberg递交的PCT国际申请第US91/05520号中。根据这些专利的提案,多元件的器具已包括具有可拆下并可抛弃的电极头或电极的可重复使用的本体。如果需要的话主体或支架可消毒并重复使用,电极头、刀片或电极或在一次使用后抛弃或消毒后再次使用。然而,仍存在一些诸如由消毒和构成一个组装器械的部件的使用的最优选择所带来的成本和时间问题。例如,根据现有的提案,一个电外科器械的期望最短使用寿命已经被验证并保持记录长度、使用形式以及器械已消毒的次数,于是要求花时间去保持这些记录。显然,这些手续可产生额外的杂费。另外,在达到期望的最短使用寿命之后这样一个器械被抛弃,除非它在预期寿命的“钟形曲线”下端,其剩余寿命、以及其它器械的剩余使用寿命没被利用,于是妨碍各个单独的器械的剩余寿命的利用并导致额外降低效率。因此,一般地一直需要一种用于监控在先进的器材、尤其是电外科器械上绝缘涂层的改进的方法,包括一种鉴别各自磨损或损耗的便宜而可靠的方法标记以便最佳地使用各个装置、同时鉴别出一点、即超出该点就不应继续使用。
发明的概述
尽管本文所实施的原理可应用到较大范围的器材和器械上,然而在此本发明是结合一改进的电外科组合装置的较佳实施例来描述的,根据本发明它包括一用于可抛弃件的电极保持器,其中保持器的一个主要表面或整个外表面是被涂以有不同预期寿命的两种涂层。第一涂层包括用于提供所需的电绝缘的基本涂层,并且特点在于存在一较长的预期寿命;另一方面,可覆盖至少一部分第一涂层的第二涂层的预期寿命比第一涂层短,并用作第一涂层的剩余寿命的无源指示器。因此,当使用时,第二涂层状态的肉眼可见的指示恒久地表明第一涂层,即基本涂层的大概的剩余寿命。在一些实施例中第二涂层的至少一部分覆盖在第一涂层的至少一部分上、并且使涂层制成不同的颜色,例如,黑与白、红与白的实施例中,当已经达到各个器械的第一涂层的剩余寿命的安全线于是需要替换时,将使它非常直观地可见。而且,通过在一覆层上采用不同的颜色,由于外界擦伤而造成的破坏可变得易于发现,因为通过如刮伤、刻伤和其它类似的损伤,下层颜色将显露。发明目的和特征
本发明的一个总目的在于对在先进器材上绝缘涂层的控制的改进。
本发明的另一个总目的在于对在电外科器具上的绝缘涂层的灵活监控。
本发明的另一个目的在于对这些器材和器具的剩余的有效寿命便于测定。
本发明的再一个目的在于增加对绝缘的电外科器具的剩余的有效寿命的利用。
本发明还有一个目的在于提供一种直观地测定个别器材或器械的剩余寿命的无源方式。
因此,根据本发明的一个特征,一个绝缘涂层置于需要绝缘的一个或多个表面上,并且具有预期寿命短于所述绝缘涂层的预期寿命的另一种材料的涂层位于所述绝缘涂层一部分之上或靠近其一部分,于是可提供一可供磨蚀的涂层,它的状态可提供恒久地指示所述绝缘涂层的剩余有效寿命。
根据本发明的另一个特征,由多个部件构成一电外科器具,包括可选择地抛弃的接头或安装到一双层涂覆的接头夹持件上的刀片,从而可方便地重复和安全使用。
根据本发明的再一个特征,双层涂覆的接头夹持件包括有不同预期寿命的至少局部地覆盖的涂层,因此这种涂层的状态可使无源直观地鉴别非常方便。
根据本发明的又一个特征,涂层可以是不同颜色的并且在供磨蚀涂层局部地覆盖在另一层上的实施例中,当下层的颜色开始显出来时,供磨蚀涂层的损坏易于察觉。
根据本发时的再一个特征,通过使用前述的一些医疗用器件的直观的鉴别,可避免记录一医疗用夹持件已经消毒过的次数或受到其它损坏而产生事件的次数,于是可提高使用时的效率。
还根据本发明的一个特征,一个前述的涂层可通过收缩-裹包方式而位于另一层之上,因而便于其包覆。
本发明的这些和其它的目的和特征从以下结合附图对本发明的较佳实施例的详细描述中可以明了。
附图的概述
图1是本发明的一个电外科用电极的立体图;
图2是图1所示电外科用电极的另一个立体图,示出了从主体上分离的刀片或接头;以及
图3是沿图2中的3-3线的截面图。
实施例的描述
在进行详细描述之前,研究一下“部分可弃型器械(resposable)”一词以下的定义可能是有所帮助的。
如本文所用的,“部分可弃型器械(resposable)”意思为一器械,其中一个部件、诸如接头或刀片可有选择地抛弃并且其中一个部分、诸如用于有选择地抛弃的部件的夹持件是可重复使用的。
虽然本文所述的用来说明的较佳实施例是关于一部分可弃型器械的,但是如上文所注意到的,应强调其原理超出这一点的并且也可以用到非部分可弃置的、可重复使用的医疗器械上,该处关注的是重复使用和消毒可降低其的性能和效用。这是电外科用电极的特别的要求,该处绝缘整体上的破口可以引起有害的并发症。除了腹腔镜检电极之外,这包括一般的外科用电极,OB/GYN电极和其它类似的电极。
现参见附图,特别是参见图1,将可见根据本发明的电外科用刀片的立体图。一复合的电外科用器械如标号10所示。它包括一主体11,它是一用于可拆卸的接头部分12的夹持件。如图所示的,接头部分12包括一终止在一变钩14上的延伸段13。当然,由于对于本技术领域中的熟练人员来说将是显而易见的,延伸段13可容易地成为一外科手术刀片或其它的外科器具。在最接近的端部15,包括一传统的导电延伸段16,它可用来进行传统方式的连接。
参见图2,图中所示的图1的复合电外科用器械已拆去可拆卸的接头部分12。由于对于本技术领域中的熟练人员来说是显而易见的,各种已知的方法中的任何一种都可用来将可拆卸的接头12固定到主体11上。然而,在图2中示出了用来插入一相应的腔室12a中的末端延伸部分11a。如图所示有一锁扣11b,它与腔室12a中的一相应的槽(未示)配合以将接头部分12牢固地锁在主体11上。
如上所述,图3是沿图2中的线3-3的截面图,它示出了前述的两个用17和18标示的涂层的较佳的位置和关系。在这一点上应注意虽然根据较佳实施例涂层都是绝缘的,但这对于本发明的实际运用来说并不是必要的。例如,虽然下涂层17应当是绝缘的,而外涂层18可以是根本不绝缘的或局部适当绝缘,只要在使用时其外观随着绝缘涂层17的剩余寿命而改变,这样它就可作为绝缘涂层17的剩余寿命的一个可靠的直观标志。同样应当理解,虽然在较佳实施例中外涂层18完全盖住了主体11上的绝缘下涂层,但这也不是本发明的实际应用时所必须的。
可拆卸的接头12可由本技术领域中熟练人员所知的所适合使用的各种材料中的任何一种所制成。然而,在本文所述的较佳实施例中,看来所用的是覆盖在不锈钢部分20上的硅树脂层19,从不锈钢部分20处伸出不锈钢延伸段13。较佳的覆盖延伸段13是一薄层碳氟化合物。
虽然如上所述的,多种导电性的和绝缘的材料可用于主体11(例如,聚醚酰亚胺和聚乙二烯氟化物),金属部分较佳地由不锈钢材料制成,绝缘涂层17为聚四氟乙烯(PTFE,Teflon),涂层18为聚烯烃。这些可通过本技术领域中熟练人员已知的各种技术来施加于其上。
在本发明的实际运用过程中,主体,即主体11,通过如高压锅蒸煮消毒后可重复使用。在每次消毒后,直观地测试绝缘损坏的标志,如上所述的通过涂层18的损坏,它将是清楚可见的。虽然这种损坏可以直观地观察而不必使用使外涂层和内涂层着上强烈的对比色的局部着色,但通过从上层颜色中透出的下层的颜色的存在可方便而显著地鉴别出外涂层的损坏。;另外,对于绝缘整体的刻伤、抓伤、刮伤及其它单独的损坏将也是易于显露的。
现在将可明白,本文已描述了一改进的复合涂层用于无源地、先进地、直观地监控其上的电绝缘状态,并且是易于使用和成本效率高的,因此对于使用者来说是有吸引力和符合要求的。
虽然本文中已通过一较佳实施例对本发明作了描述,然而应当理解,只要不脱离本发明的实质精神和范围还可对其作出其它应用和变化。因此,本发明的原理被认为对于除了上述的具体的较佳实施例之外的较大范围的器具和其它产品也有适用性。它们的例子可以是其它具有绝缘涂层的腹腔镜和非腹腔镜器械。
本文所用的术语和用词仅作为描述用语而不能作为对本发明的限制;因此,此处没有排除等同事物的用意,但另一方面只要不脱离本发明的实质精神和范围这些用词也有意于包括可能采用的任何和所有的等同事物。
Claims (21)
1.一器械,具有:
(a)一基面;
(b)一位于所述基面上的绝缘涂层;以及
(c)与所述绝缘涂层靠近的另一个涂层,所述另一个涂层具有比所述绝缘涂层短的预期寿命,通过对所述另一个涂层的直观观察可揭示所述绝缘涂层的可能的剩余寿命小于一可靠极限时的情况。
2.如权利要求1所述的器械,其特征在于,所述绝缘涂层和所述另一个涂层是不同颜色的。
3.如权利要求1所述的器械,其特征在于,所述另一个涂层是邻接所述绝缘涂层的。
4.如权利要求1所述的器械,其特征在于,所述另一个涂层的一部分直接覆盖在所述绝缘涂层的一部分上。
5.如权利要求1所述的器械,其特征在于,所述器械是一医疗器械,它有一具有基本的外部工作表面的细长本体。
6.如权利要求5所述的医疗器械,其特征在于,所述第一层基本覆盖着所述基本外部工作表面。
7.如权利要求5所述的医疗器械,其特征在于,所述第二层覆盖着所述第一层的一部分。
8.如权利要求7所述的医疗器械,其特征在于,所述第二层覆盖着所述第一层的一部分。
9.如权利要求8所述的医疗器械,其特征在于,所述第二层覆盖着所述第一层的全部。
10.如权利要求6所述的医疗器械,其特征在于,所述第二层覆盖着所述第一层的全部。
11.如权利要求5所述的医疗器械,其特征在于,所述第二层是绝缘的。
12.如权利要求6所述的医疗器械,其特征在于所述第二层是绝缘的。
13.如权利要求5所述的医疗器械,其特征在于,所述细长的本体是由多个部件组成的。
14.如权利要求5所述的医疗器械,其特征在于,所述细长的本体包括两个基本部件。
15.如权利要求5所述的医疗器械,其特征在于,所述细长的本体包括一个可拆卸的接头部件和一个装到所述可拆卸的接头部件上的主体。
16.如权利要求15所述的医疗器械,其特征在于,所述基本的外部工作表面即在所述主体的一个表面上的。
17.一种检测医疗器械上的绝缘涂层的剩余寿命的方法,包括:
(a)将所述绝缘涂层置于所述器械的一个可见的可接近的表面上;
(b)提供另一种预期寿命比所述绝缘涂层短的材料,所述另一种材料的剩余的预期寿命直观地观察是显而易见的;
(c)将所述另一种材料置于所述器械的一可见的可接近表面上;以及
(d)定期地观察所述可见的可接近的表面上的另一种材料以直观地确定其剩余的预期寿命。
18.如权利要求17所述的方法,其特征在于,将所述另一种材料置于所述器械的所述可见的可接近表面上的步骤包括将所述另一种材料收缩-裹包在所述可见的接近表面上。
19.如权利要求17所述的方法,其特征在于,还包括将所述器械制成为多个部分,包括一可任意弃置的接头和一可重复使用的主体;并且其中设置所述绝缘涂层的步骤包括将所述绝缘涂层固定到所述主体的一个工作表面上。
20.如权利要求19所述的方法,其特征在于,在所述器械的一个可见的可接近表面上设置另一种材料的步骤包括将所述另一种材料置于所述绝缘涂层上。
21.如权利要求19所述的方法,其特征在于,将所述另一种材料置于所述器械的一可见的可接近表面上的步骤包括将所述另一种材料置于所述绝缘涂层的基本的全部表面上。
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US08/342,215 US5531743A (en) | 1994-11-18 | 1994-11-18 | Resposable electrode |
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US08/547,571 | 1995-10-24 | ||
US08/547,571 US5846237A (en) | 1994-11-18 | 1995-10-24 | Insulated implement |
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US (1) | US5846237A (zh) |
EP (1) | EP0847252B1 (zh) |
JP (1) | JP3691067B2 (zh) |
CN (1) | CN1149961C (zh) |
AU (1) | AU695979B2 (zh) |
DE (1) | DE69533205T2 (zh) |
NZ (1) | NZ296194A (zh) |
TW (1) | TW364842B (zh) |
WO (1) | WO1996016587A2 (zh) |
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CN108124447A (zh) * | 2015-07-02 | 2018-06-05 | 艾斯丘莱普股份公司 | 用于电外科手术中的施加器的涂层 |
CN108124447B (zh) * | 2015-07-02 | 2021-05-25 | 艾斯丘莱普股份公司 | 用于电外科手术中的施加器的涂层 |
Also Published As
Publication number | Publication date |
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EP0847252A4 (zh) | 1998-07-01 |
CN1149961C (zh) | 2004-05-19 |
JP3691067B2 (ja) | 2005-08-31 |
AU695979B2 (en) | 1998-08-27 |
DE69533205T2 (de) | 2005-08-04 |
US5846237A (en) | 1998-12-08 |
AU3991995A (en) | 1996-06-19 |
EP0847252B1 (en) | 2004-06-23 |
JPH09507781A (ja) | 1997-08-12 |
WO1996016587A3 (en) | 1996-09-19 |
TW364842B (en) | 1999-07-21 |
NZ296194A (en) | 1997-06-24 |
DE69533205D1 (de) | 2004-07-29 |
WO1996016587A2 (en) | 1996-06-06 |
EP0847252A2 (en) | 1998-06-17 |
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