CN1486667A - 带有一次性鞘套的内窥镜系统 - Google Patents
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Abstract
带有一次性鞘套的内窥镜系统,属于医疗器械技术领域,包括有镜体和开口管道,其特点是内窥镜系统中还设置有一个由透明坚韧材料制成的隔离套囊,该隔离套囊套在内部不设任何开口管道的镜体上,在隔离套囊的外边设置有连为一体的管道联体,与现有技术相比,本发明有益效果是:取消原有内窥镜镜体内的各种占位较大、不易清洗消毒的开口管道,并将这些管道移到装套在内窥镜镜体外面的套囊的外面,患者使用后,即可将套囊连同外面的管道完全弃扔,而价格昂贵的内窥镜镜体因受到保护而不受污染,只需普通消毒或快速擦拭处理就可再次使用,既提高了内窥镜的周转率,又延长了内窥镜的使用寿命。
Description
技术领域
本发明涉及一种内窥镜,特别涉及一种带有一次性鞘套的内窥镜系统,属于医疗器械技术领域,适于各类医院使用。
背景技术
医用内窥镜作为微创外科手术和直观探察以及特有的明视活检功能可为确诊提供依据等重要手段,在现代医学领域中已成为无可替代的技术。但就诸如上述活检过程所能产生的医源性污染又不容忽视,尤其近年血液病毒传播的可怕性令人望而却步!为此,人们将很多小型医疗器械尽可能改为一次性使用,但医用内窥镜因为造价较高而不适合一次性使用,内窥镜作为介入器械,消毒确是大问题,近年对一般硬性内窥镜可用新发展起来的高温消毒办法解决消毒问题,而各种软性镜是不能耐受高温消毒的,内窥镜中各种开口管道更是无法彻底清洁消毒,比如活检钳道所能受到污染的危险性之大可想而知。为此自廿世纪九十年代以来,国内外均有人开始探讨解决途径,其中较为接近可行的有美国专利5,025,778号和5,876,329号,他们各具特色,但都有其不易实施之处,例如美国专利5,025,778号给出实施方案的图示结构:图2B所示管道「54」是由两层物质构成,前端开口呈张开状,容易划伤体腔粘膜;图8所示的管道「54」则相反,全管处于闭合状,管道很长,插入器械过程不顺畅,管道有被刺破危险。而美国专利5,876,329号给出实施方案的图示结构,将内窥镜制成C字型,软性镜需要弯曲转向,其制作难度大,鞘套的造价也较高,影响其产品在市场上销售和使用。
发明内容
本发明的目的在于克服现有技术的上述不足,通过对现有内窥镜结构做了实质性的改进,给出了一种带有一次性鞘套的内窥镜系统,该内窥镜系统是将软性内窥镜易受污染的各种开口管道在镜体中取消,从而压缩了新系统中特制内窥镜的直径,并将其头部前端进行适当改形,临床应用时套上与内窥镜外形相适应的隔离套囊,最后利用内窥镜头部的变形所提供的空间,将原内窥镜镜体中的各种开口管道的金属头部,经弹簧圈固定在已套有隔离套囊的内窥镜的前端部,各开口管道的金属头部与各自软管相连,发挥各自功能。全系统用后,因为内窥镜体已被隔离套囊保护,只将隔离套囊及套囊以外与各开口管道连为一体的弹簧圈拿掉,实现一次性使用,做到了消毒可靠、方便经济、实用性强和便于推广。
基于将易受污染的各种开口管道从原内窥镜镜体中取消,并移置到套有内窥镜镜体的隔离套囊的外面这一总的发明构思,新系统中特制内窥镜的头部前端也可不进行适当改形,即保持原先的普通圆柱形,此时设置的开口管道直接粘接在隔离套囊外面,开口管道前端的开口边缘可与套囊前端周边同轴地呈线性浅表地烫合在一起,实行暂时闭合。也可用可溶塞将开口管道前端的开口堵塞。
本发明给出的技术解决方案是:这种带有一次性鞘套的内窥镜系统,包括有镜体和开口管道,其特点是内窥镜系统中还设置有一个由透明坚韧材料制成的隔离套囊,该隔离套囊套在内部不设任何开口管道的镜体上,在隔离套囊的外边设置有连为一体的管道联体。
其中所述镜体的头部形状,可以适当改形,例如本发明给出的一种端面“D”字形,也可以不进行改形,而保持原先普通的圆柱形,所述镜体的后部根据需要,可以设置或不设置注水注气手阀:设置注水注气手阀是为了方便利用原有手阀和机箱内的注水注气设备;不设置注水注气手阀是为了更高度保证水、气万一产生的倒流所能出现的污染。不设置注水注气手阀的,注水注气管道的后端可与注射器或一次性使用的专用注水注气机通过接头联接使用,代替原有在机箱内的多次使用的注水注气机。此时的内窥镜镜体仅由观察系统(物镜、目镜、传象束或CCD等)、传光系统、方向操纵系统和包皮等构成,并由于取消了占位较大的各开口管道,而大大压缩了镜体的直径。所述镜体的物镜前端面应高于镜体的其它前端面,以利于该物镜前端面与隔离套囊前端面紧密贴合,以防止杂光进入。
所述隔离套囊的头部形状与镜体的头部形状相匹配,其尺寸以能够适度套进为宜,后部则较镜体宽松,长度视卫生要求程度而定,可以套在手柄近处,也可以将手柄全部包裹,采用透明坚韧材料制成的隔离套囊应保证病毒等不能透过。
所述开口管道联体是由新的内窥镜镜体中所取消了的各种开口管道组成,其前端金属管部分通过弹簧圈连为一体,前端适度弯曲的金属管部分排列并焊接在弹簧圈上,其后部与各自软性管相连接,有的管道后端设有插钳口和吸引接头(即分流管)。有的管道后端还设有分流头,可与内窥镜手柄上的注水和注气手阀连接,也可与注射器联接,以便向喷头注水或注气。
与现有技术相比,本发明给出的这种带有一次性鞘套的内窥镜系统的有益效果如下:
1.取消原有内窥镜镜体内的各种占位较大、不易清洗消毒的开口通道,并将这些通道移到装套在内窥镜镜体外面的隔离套囊的外面,患者使用后,即可将隔离套囊连同外面的管道完全弃掉,而价格昂贵的内窥镜镜体因受到保护而不受污染,只需普通消毒或快速擦拭处理就可再次使用,既提高了内窥镜的周转率,又延长了内窥镜的使用寿命。
2.隔离套囊采用透明、柔软、坚韧、无弹性且不能透过病菌的材料制造,具有设计合理、结构简单、无毒和生物相容性好的特点。
3.本发明较美国专利5,876,329号的实质性区别在于:5,876,329号专利将内窥镜镜体制成轴向为C字形结构,这对镜体中转向弯曲的蛇骨部份增大了制作难度,器械管道复杂,制造成本过高,而本发明的镜体头部形状可以适当改形,例如本发明给出的一种头部端面呈“D”字形;也可以不进行改形,而保持原先普通的圆形,由于只在圆柱形的镜体的头部制成轴外视向的“D”字形的端面,而并不改变现有内窥镜的弯曲转向的园桶形蛇骨结构,工艺成熟,成本不高,更具实用性。
4.本发明较美国专利5,025,778号的实质性区别在于:镜体隔离套囊(鞘套)外的开口管道的前端边缘做了如下处理:a.实行暂时封闭措施;b.用可容塞封堵。从而解决了开口管道的开口在圆柱镜体外划伤体腔粘膜的可能,而在本发明给出的镜体头部端面为“D”字形的内窥镜中,由于设置的弹簧圈的外周边为倒圆、无棱角,更易插入腔体而不会划伤体腔粘膜。
附图说明
图1为本发明给出的一种实施例(镜体头部端面为“D”字形)头部的结构示意图;
图2为图1中头部变形的内窥镜镜体的示意图;
图3为图1中隔离套囊的示意图;
图4为图1中开口管道联体的示意图;
图5为开口管道联体的金属体组成的示意图(在未套上弹性管之前);
图6为注水注气管与注水注气手阀联接的全系统示意图;
图7为注水注气管与注射器联接及套囊后部包裹的全系统示意图;
图8为本发明给出的另一种实施例(镜体头部形状为普通圆形)的开口管道的开口被可溶塞封堵的示意图;
图9为图8中的开口管道的前端开口被暂时封闭的示意图;
图10为本发明给出的另一种实施例(镜体头部形状为普通圆形)的喷嘴示意图;
图11为图8的开口管道的前端端面示意图;
图12为图9的开口管道的前端端面示意图。
具体实施方式
下面结合附图对本发明的具体技术方案做进一步说明:
如图1~图5所示,这种带有一次性鞘套的内窥镜系统,包括有镜体1和开口管道,其特点是内窥镜系统中还设置有一个由透明坚韧材料制成的隔离套囊6,该隔离套囊6套在内部不设任何开口管道的镜体1上,在隔离套囊6的外边设置有连为一体的管道联体。图1表明,由于将软性内窥镜易受污染的各种开口管道在镜体1中取消,从而压缩了内窥镜的直径,其头部前端也进行了适当改形,临床应用时套上与内窥镜外形相适应的隔离套囊6,最后利用内窥镜头部的变形所提供的空间,将原内窥镜镜体中的各种开口管道的金属头部8,经弹簧圈10固定在内窥镜的前端部,各开口管道的金属头部8与各自软管9、15相连,发挥各自功能,这时的内窥镜系统的直径周长并不大于原来的内窥镜,又因为人体腔道是软组织,本发明虽然不是完全的圆柱体,也不会增大体腔的横向压力,而且管道8的后边是由软管构成,经过狭窄部会被压瘪,更省下空间。图1所示的内窥镜系统是双钳道、大钳道的高性能电子结肠内窥镜,其截面长轴在未被腔道挤压情况下略大于相应原有电子结肠内窥镜直径,但经挤压就小于原有电子结肠内窥镜直径,而且截面短轴尺寸却远小于原有电子结肠内窥镜直径,本发明前端周长仅为目前国际先进相同性能指标的电子镜的前端周长的75%;图2表明,镜体1的头部前端进行了适当变形,前端面为“D”字形,此时的内窥镜镜体1由观察系统(物镜、目镜、传象束或CCD等)、传光系统、方向操纵系统和包皮等构成,由于取消了占位较大的各开口管道,而大大压缩了镜体1的直径。镜体1的物镜前端面3高于镜体1的其它前端面,以利于该物镜前端面3与隔离套囊6前端面7紧密贴合,以防止杂光进入;图3表明,隔离套囊6是专为保护内窥镜镜体而设计,是用高度透明、坚韧、无毒和不能透过病毒和毒素的材料制作,其头部形状5与镜体1的变形头部2形状相匹配,其尺寸以能够适度套进为宜,后部则较镜体宽松,长度视卫生要求程度而定,可以套在手柄近处,也可以将手柄全部包裹;由图4所知,开口管道联体是由新的内窥镜镜体中所取消了的各种开口管道组成,其前端金属管8部分通过弹簧圈10连为一体,前端适度弯曲的金属管8部分,排列并焊接在弹簧圈10上,其后部与各自软性管相连接,弹簧圈10有开口12,是为增强弹性,在弹簧圈10的前端下部设置有起覆盖作用的薄片11,薄片11有若干圆孔13、14,可对准镜体1的物镜3和光导4等光孔,使套囊6前端面7与物镜的端面3紧密贴合而不进杂光,喷嘴16是注水注气管道9的出口并用于冲洗镜头;图5表明了在未套上弹性软管9、15之前,开口管道联体的金属体连为一体情况。使用时,相继将镜体1套上隔离套囊6和管道联体,管道联通过弹簧圈10将开口管道与套有镜体1头部的隔离套囊紧固在一起。
图6表明了注水注气管与注水注气手阀联接的全系统的工作情况,图7表明了注水注气管与注射器联接及套囊后部包裹的全系统的工作情况,如图6~图7所示,内窥镜的后部根据需要,可以设置或不设置注水注气手阀23,设置注水注气手阀23(图6),是为了方便利用原有手阀23和机箱内的注水注气设备;不设置注水注气手阀(图7},是为了更高度保证水、气万一产生的倒流所能出现的污染。不设置注水注气手阀的,注水注气管道9的后端可与注射器25或一次性使用的专用注水注气泵通过接头17、18联接使用,代替原有在机箱内的多次使用的注水注气机。同样,开口管道连体的操作管道15后端设有可插入器械和连接吸引机的分流管,并分别做了如下处理:
①.钳道与吸引管的端部19,(即分流管)示于图6、图7,插钳口22设有橡皮头(或类似物)21,起到密封作用,避免吸引时漏气和操作时漏水。吸引接头20可与吸引机联接,进出器械与吸引功能可以同时进行,也可以分别进行;
②.注水注气管道9的后端,可以与原镜体手柄的注水注气手阀23在镜体手柄近端接头17、18联接,如不放心还可不设注水注气手阀23,而与注水和注气的两支注射器25连接,在镜体和开口管道的中后部还设有带扣24,以使中后部的各种管道与镜体更好地绑束在一起。
图8~图12表明了本发明给出的另一种实施例(镜体头部形状为普通圆形)的内窥镜头部情况。其中从图11和图12中可知内窥镜镜体头部形状并未变形,仍为原来的圆柱形,图8、图9和图10表明开口管道直接与套有镜体1的隔离套囊6的外边粘接在一起的情况,开口管道的前端开口实行了暂时闭合,图8采用的是在开口管道的前端开口处设有可溶塞26,在镜体插入过程中将开口管道15堵塞,当镜体进入工作部位需要插入器械时,再将可溶塞26推出管口开始工作,而可溶塞26在腔内经过一段时间会溶化或排出。图9采用的是将开口管道15的前端开口处的边缘与隔离套囊6前端周边同轴浅表的烫合在一起,形成临时封口27,从而避免开口管道15的开口处划伤体腔粘膜,开口管道15其余部分仍呈软管状,当使用管道时,用闭合状的活检钳头部捅开封口27,活检钳等就可工作。如果需要插入的器械是锋利的剪力等物,可采用上述办法先用活检钳的闭合头部将封口27捅开后,再换用剪刀等插入工作。图10是粘附在隔离套囊6的外边的注水注气管道9的情况,图中所见的喷嘴16可以在隔离套囊6的外边对物镜部份喷洗和注水注气。在本实施例中,内窥镜的物镜前端外可设一平行平板玻璃或光栏圈以防杂光。
本发明也适用在原有的内窥镜上,即用隔离套囊6套住原有的内窥镜,以保证其不受污染,而将原有内窥镜中的各个开口管道封闭起来,而相应的管道则粘贴在隔离套囊6的外边,做完手术后,再将隔离套囊6以及其外面的各管道9、15和喷嘴16全部拿掉进行无害化处理,实现一次性应用。
Claims (10)
1.一种带有一次性鞘套的内窥镜系统,包括有镜体和开口管道,其特征在于内窥镜系统中还设置有一个由透明坚韧材料制成的隔离套囊,该隔离套囊套在内部不设任何开口管道的镜体上,在隔离套囊的外边设置有连为一体的管道联体。
2.根据权利要求1所述的带有一次性鞘套的内窥镜系统,其特征在于当所述镜体的头部端面是“D”字形时,设置在隔离套囊外面的管道联体前端处设置有一弹簧圈,该弹簧圈将开口管道的金属头部固定在已套有隔离套囊的内窥镜的前端部。
3.根据权利要求1所述的带有一次性鞘套的内窥镜系统,其特征在于当所述镜体的头部形状是普通的圆形时,设置在隔离套囊外面的开口管道前端的开口边缘与隔离套囊前端周边同轴浅表地烫合在一起。
4.根据权利要求1所述的带有一次性鞘套的内窥镜系统,其特征在于当所述镜体的头部形状是普通的圆形时,设置在隔离套囊外面的开口管道的前端开口处设有可溶塞。
5.根据权利要求1所述的带有一次性鞘套的内窥镜系统,其特征在于隔离套囊的头部形状与镜体的头部形状相匹配,其后部较镜体宽松。
6.根据权利要求1所述的带有一次性鞘套的内窥镜系统,其特征在于镜体的物镜前端面高于镜体前端平面。
7.根据权利要求2所述的带有一次性鞘套的内窥镜系统,其特征在于弹簧圈的前端面上设置有起覆盖作用的带孔薄片。
8.根据权利要求3或4所述的带有一次性鞘套的内窥镜系统,其特征在于镜体物镜前端外设置有防杂光的平行平板玻璃或光栏圈。
9.根据权利要求1所述的带有一次性鞘套的内窥镜系统,其特征在于隔离套囊外的注水注气管与注射器或一次性使用的注水注气泵对接。
10.根据权利要求1所述的带有一次性鞘套的内窥镜系统,其特征在于隔离套囊外的操作管后端设有可插入器械和连接吸引机的分流管。
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Also Published As
Publication number | Publication date |
---|---|
AU2003261638A1 (en) | 2004-06-18 |
CN100337579C (zh) | 2007-09-19 |
CN1697624A (zh) | 2005-11-16 |
WO2004047626A1 (en) | 2004-06-10 |
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