CN108289686A - 电刀止血夹 - Google Patents

电刀止血夹 Download PDF

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CN108289686A
CN108289686A CN201680070447.3A CN201680070447A CN108289686A CN 108289686 A CN108289686 A CN 108289686A CN 201680070447 A CN201680070447 A CN 201680070447A CN 108289686 A CN108289686 A CN 108289686A
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clamp arm
pipe
chipware
distal
distal end
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CN108289686B (zh
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保罗·史密斯
皮特·代顿
塞缪尔·雷宾
雷·H·唐
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Boston Scientific Scimed Inc
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Abstract

一种用于治疗组织的装置包括管，管从近端纵向延伸到远端并包括延伸穿过管的通道，管可释放地联接到装置的近侧部，且夹臂的近端可滑动地容置在管的通道中使得夹臂可在开放构型和闭合构型之间移动。芯件连接到夹臂，芯件包括可释放地彼此连接的近侧部和远侧部，使得当芯件经受预定负载时，近侧部和远侧部彼此分离。导电控制件连接到芯件，连接件的近端连接到向夹臂传输电流的电源。

Description

电刀止血夹
优先权主张
本申请要求了2015年12月3日提交的美国临时专利申请No.62/262,729的优先权，该文献的内容通过引证并入本文。
背景技术
医生对于执行更积极的侵入性和具疗效的内窥镜手术的意愿越来越高，包括例如去除较大损伤(如，癌症肿块)、在胃肠(GI)道的粘膜层下进行隧道手术以治疗粘膜下的问题、全层组织切除、将装置插入通过GI道接着穿透GI器官以治疗GI道的外围组织、内窥镜治疗及/或术后问题的修复(如，手术后泄漏、手术缝线的分解及吻合处泄漏)。这些手术可能增加穿孔或损伤GI道壁的风险，或者手术中可能需要包括封闭GI道壁的程序。使用内窥镜进行闭合能降低成本，并减少与这些手术相关的创伤和不便。然而，现有的组织闭合装置可能不足以进行某些组织缺陷的闭合。
发明内容
本发明涉及一种治疗组织的装置，包括从近端朝远端纵向延伸的管，管包括延伸穿过管的通道，管可释放地与装置的近侧部联接。夹臂的近端可滑移地容置在管的通道中，从而使夹臂可在开放构型与闭合构型之间移动，在开放构型中夹臂的远端朝远侧延伸并越过管的远端而彼此分离，在闭合构型中通过管的内表面限制夹臂，从而使夹臂的远端朝彼此拉近。联接于夹臂的芯件包括近侧部与远侧部，近侧部与远侧部可释放地彼此连接，因此当芯件经受预定负载时，近侧部和远侧部彼此分离。与芯件连接的导电控制件，被连接件的近端与电源连接用来将电流传输到夹臂。
在一个实施例中，装置的近侧部包括柔性件与位在柔性件远端的衬套。
在一个实施例中，柔性件与衬套通过非导电件而彼此隔开，从而保护柔性件免受电流影响。
在一个实施例中，芯件的近侧部与远侧部通过可断开连接件而彼此连接。
在一个实施例中，管是绝缘和由非导电材料制成中的其中之一。
在一个实施例中，管是由导电材料制成。
在一个实施例中，控制件的部分为绝缘，从而保护装置的近侧部。
在一个实施例中，夹臂的部分为绝缘，从而提供电流到夹臂的期望部分。
在一个实施例中，芯件的近侧部包括限制突片用来卡合夹臂的近端，远侧部包括对齐突起用来连接横向延伸穿过每个夹臂的相应切口。
在一个实施例中，夹臂的远端包括朝彼此横向延伸的尖锐齿，当通过夹臂接收电能时，尖锐齿用来烧灼夹在夹臂之间的组织。
在一个实施例中，当电能被夹臂所接收，夹臂的内表面被构造成对组织进行凝血。
本发明也涉及一种夹持装置包括具有柔性件和衬套的近侧部，柔性件从近端纵向延伸至远端，衬套连接到柔性件的远端。可释放地耦接至近侧部的远侧部，因此远侧部可从夹持装置展开。远侧部包括可释放地联接于衬套的管，管从近端纵向延伸至远端并包括延伸穿过管的通道。夹臂从可滑移地容置在管的通道中的近端而延伸，因此夹臂可在开放构型与闭合构型之间移动，在开放构型中夹臂的远端朝远侧延伸并越过管的远端而彼此分离，在闭合构型中通过管的内表面限制夹臂，从而使夹臂的远端朝彼此拉近。联接至夹臂的近端的芯件，芯件包括通过可断开连接件彼此连接的近侧部与远侧部，可断开连接件设计成在经受预定负荷时会失效。连接至芯件的导电控制线，被连接件的近端连接至电源用来传输电流至夹臂。
在一个实施例中，装置进一步包括延伸覆盖控制线的一部份的绝缘衬套。
在一个实施例中，夹臂的远端包括侧向朝彼此延伸的尖锐齿。
在一个实施例中，夹臂的部分为绝缘。
本发明也涉及一种治疗目标组织的方法，方法包括插入夹持装置的远侧部到活体内的目标区域，远侧部包括管与夹臂，夹臂可滑移地接受在管中从而可在开放构型与闭合构型之间活动。在开放构型中夹臂的远端彼此分离，在闭合构型中夹臂的远端彼此拉近，远侧部可释放地与装置的近侧部联接，因此远侧部可从夹持装置展开，将夹臂定位于与目标组织接触，并通过连接到管和夹臂中之一的导电件而传输电能至夹臂，从而治疗目标组织。
在一个实施例中，将夹臂定位于与目标组织接触的步骤包括将夹臂朝开放构型移动，因此夹臂的内表面位在与目标组织接触从而将目标组织进行凝血。
在一个实施例中，将夹臂定位于与目标组织接触的步骤包括将目标组织夹持于位在夹臂远端上的尖锐齿之间从而烧灼目标组织。
在一个实施例中，方法进一步包括通过在开放构型中将组织的目标部分定位于夹臂的远端之间而夹持组织的目标部分，以及将夹臂拉往闭合构型从而夹持组织的目标部分。
在一个实施例中，方法进一步包括在闭合构型中锁定夹臂并将远侧部从装置的近侧部展开。
附图说明
图1是示出根据本发明的示例实施例的装置的纵向剖视图；
图2是示出根据本发明的替代实施例的装置的纵向剖视图；
图3是示出根据本发明的另一示例实施例的装置的纵向侧视图；
图4是示出图3的装置的纵向剖视图；
图5是示出根据本发明的另一替代实施例的装置的部分透视立体图；以及
图6是示出图5的装置的纵向剖视图。
具体实施方式
参考以下描述和附图可以进一步理解本发明，其中相同的元件使用相同的附图标号来做表示。本发明涉及用于治疗组织穿孔、缺陷和/或出血的内窥镜夹持装置。具体而言，本发明的示例实施例描述了具有夹持和凝血功能的止血夹。一部份的夹持装置是绝缘的或由非导电材料制成以实现理想的凝血效果。应该注意的是，如本文所使用的术语“近侧”和“远侧”旨在表示装置朝向(近侧)和远离(远侧)使用者。
如图1所示，根据本发明的示例实施例的装置100包括远侧部102，远侧部102可通过例如内窥镜的工作通道而插进活体中以到达等待治疗的目标组织。该装置具有足够的柔性以容许穿过身体内的曲折路径-例如穿过内窥镜的工作通道插入通过身体自然孔腔而进入的自然体腔。远侧部102包括一对夹臂104，夹臂104可滑移地容置于管106的纵向通道122之中。夹臂104可在开放构型与闭合构型之间移动，开放构型中夹臂104的远端108彼此分离以将目标组织容置于其中，闭合构型中夹臂104的远端108朝彼此移动以将目标组织夹在其中。远侧部102可释放地联接至装置100的近侧部110，近侧部110包括当展开远侧部102时保持身体外部让使用者可接触的手把(未示出)。夹臂104通过延伸进入管106的控制件112而可以在开放与闭合构型之间移动。控制件112的近端也联接于能量源，能量源通过控制件112将电流提供给夹臂104以向目标组织提供能量，以下将做进一步详细描述。
装置100的近侧部110包括将管106连接至手把的柔性件118。柔性件118例如使用线圈或任何其他适合的柔性结构而制成，其促进装置100的远侧部102通过活体的曲折路径而插入。管106通过衬套120连接至柔性件118，衬套120可释放地联接于管106。控制件112延伸穿过柔性件118、衬套120与管106而连接至夹臂104。柔性件118与衬套120被电性绝缘和/或由非导电材料制成以保护使用者、周围器械和非目标组织免受其影响。可使用粉末涂层、收缩管或通过使用非导电成分例如塑料和/或陶瓷来施加绝缘。绝缘材料可包括缩醛(POM)、环氧树脂、FEP、聚酰胺、PVDF、酚醛树脂、PFA、聚碳酸酯、聚砜、PVC、聚苯硫醚、聚醚酰亚胺、硅树脂、聚醚醚酮(PEEK)、聚四氟乙烯(PTFE)和聚乙烯。绝缘体的厚度可以在0.0005英寸(0.0127mm)和0.020英寸(0.508mm)之间，更具体地，是在0.002英寸(0.0508mm)和0.006英寸(0.1524mm)之间。
衬套120从连接于柔性件118的远端126的近端124纵向延伸至可释放地联接至管106的衬套远端128。在一个示例中，衬套120包括至少一个开口130，开口130横向延伸穿过衬套120以用于容置管106的相应连接突片132。然而，衬套120可包括多个开口，而且在一个特定实施例中，衬套120包括一对径向相对的开口。类似于管106和柔性件118，衬套120可以是绝缘和/或由非导电材料形成，以防止周围部受到通过穿过衬套120的控制件112的电流影响。在另一个实施例中，控制件112的长度穿过柔性件117与衬套120，控制件112可以是绝缘的和/或被鞘套158覆盖以避免电流从控制件112传输到装置100的周围部。覆盖控制件112的绝缘件和/或鞘套158为夹持装置的周围部提供额外的保护。在本实施例中，柔性件118与衬套120不需为绝缘的/非导电的。
管106包括数个连接突片132相应于衬套120中成对的开口130。管106从近端134纵向延伸至远端136，并包括纵向延伸穿透管106的通道122。连接突片132从近端134放射状地朝内延伸，因此当突片132被容置在衬套120的一个相应的开口130之中，管106与衬套120彼此联接。管106也包括一对窗口138，窗口138沿着管106的近侧部横向延伸穿过管106。如以下将进一步详细描述的那样，一对窗口138的大小、形状和构造是用来容置夹臂104的近端116上的锁定件140。虽然装置100被示出是经由开口130和连接突片132将衬套120和管106联接，但只要衬套120和管106可释放地彼此联接且当装置100的远侧部102展开时可释放衬套120和管106，衬套120和管106可利用多种方式中的任一种相互联接。
本实施例的夹臂104通过芯件142连接至控制件112，芯件142包括近侧部144与远侧部146，近侧部144与远侧部146可释放地彼此连接，因此经受了预定负载的近侧部144和远侧部146会彼此分离。在一个实施例中，可释放连接设计成在经受预定负载时会分离或断开的可断开连接件148。可断开连接件经由焊接或其他适合的连接而形成，只要此连接保持定位直至经受预定负载，且施加负载时此连接即失效。芯件142由导电材料形成，因此通过控制件112的电流通过芯件142而至夹臂104。通过例如容置在位于近侧部144内具相应尺寸与形状的空腔154中的扩大远端114，将控制件112的远端114连接至近侧部144。因此，当控制件112相对于管106纵向移动，芯件142以及连带夹臂104相对于管106相应地移动。
本实施例的近侧部144包括定位于近侧部144的相对侧的一对突片150，用来卡合夹臂104的近端116。远侧部146包括对齐突起152，每个对齐突起152纵向对齐于相应的一个突片150，对齐突起152卡合于横向延伸穿过夹臂104一部分而具相应尺寸和形状的切口。对齐突起152使得夹臂104相对于彼此保持对齐状态。虽然芯件142被描述和示出是具有经由可断开连接件148彼此连接的部分的单一元件，但夹臂104可经由其他机构彼此连接和对齐。举例来说，如本领域技术人员所理解的，芯件142可以是单一的或者由通过可分离接头以各种方式彼此连接的两个以上的分离元件所组成。
夹臂104朝向开放构型偏压，因此当夹臂104朝远侧移动而越过管106的远端136，夹臂104的远端108彼此分离至开放构型。当夹臂104被朝近侧拉进管106内，夹臂104通过接触管106的内表面而朝闭合构型移动，且通过管106将夹臂104保持在闭合位置。如上所述，夹臂104通过控制件112在开放与闭合构型之间移动。夹臂104由导电材料制成，因此经过控制件112的电流穿过夹臂104到达与夹臂104接触的目标组织。夹臂104和管106的配置使得将夹臂104拉往闭合构型而需要的拉动距距，令控制件112的导电部、芯件142和夹臂104永远不会被拉进柔性件118的导电部。
具有小电流发射区域(例如尖锐边缘)的夹臂104的特征可用作烧灼边缘或切割边缘。例如，位于夹臂104的远端108上的尖锐齿109朝彼此侧向延伸，因此当尖锐齿109之间夹持组织时，尖锐齿109可用来烧灼他们接触到的组织。具有大电流发射区域例如平滑表面的特征可用来凝血。例如，沿着夹臂104长度的内表面156(如当夹臂104一起被拉住，彼此面对的夹臂104的表面)压迫到组织时可用来提供凝血功能。在另一示例中，夹臂104朝闭合构型移动，因此远端108的尖锐齿109结合在一起从而形成平滑远侧边缘。该平滑远侧边缘用来对组织的小区域进行凝血。在又一示例中，在闭合构型中夹臂104的远侧表面，可以被压迫到目标组织从而将该组织进行凝血。夹臂104的不同区域压迫到组织时对组织提供不同功能。以这种方式，尖端的几何形状和材料构造可改变作用在组织上的电流密度。诸如夹臂104的内表面或外表面上的大面积提供较低的电流密度效应用来凝血。更小、更尖锐的区域，例如夹臂104的尖端或尖锐齿109，提供更高的电流密度效应用来切割。尽管示例性实施例示出并描述了所有的夹臂104全部都可导电，但也可使一部分的夹臂104为绝缘，仅仅只有期望的一部分可导电。例如，希望仅有夹臂104的远端可导电。
如上所述，装置100用来对目标组织进行烧灼/切割、凝血和/或剪切，根据需要或必要来治疗目标区域。烧灼与凝血功能经由开启或关闭连接到控制件112近端的电源进行供电控制。当期望对组织进行烧灼或凝血时，将电源通电，使得电流传输到夹臂104。一旦达到所需的烧灼和/或凝血功能，或者当期望利用装置100的夹持方面时，将电源断电，使得夹臂104定位在目标组织上并夹持目标组织而不需进一步将能量施加到被切下的组织上。一旦目标组织已经定位在夹臂104之间，夹臂104可朝向闭合构型移动，使得装置100的远侧部102在目标组织上展开，下文将进行更详细的描述。
根据示例性的方法，装置100的远侧部102穿过例如内窥镜的工作通道插入活体内的目标区域。远侧部102在闭合构型中插入穿过工作通道。然而，一旦远侧部102抵达目标区域，通过将控制件112相对于管106朝远侧移动从而使夹臂104移动至开放构型。夹臂104可在开放和闭合构型之间移动而利用可达成预期效果的方式来夹持和/或接触组织。例如，夹臂104的远端10在开放构型中可定位在待切割的组织区域附近以提供切割功能。夹臂104被拉往闭合构型，因此期望被切割的目标区域的一部份被夹持在夹臂104的远端108的齿109的尖锐边缘之间。将电源通电，使得通过控制件112的电流穿过夹臂104到达远端108从而烧灼/切割被夹持的组织。也期望对目标区域中组织的一部分提供凝血。在一个示例中，夹臂104在开放构型中被定位而横跨待处理的一部份组织，使得内表面156接触待治疗的组织。夹臂104略微朝闭合构型移动从而增加与组织接触的面积。在另一个示例中，夹臂104在闭合构型中可形成平滑的远侧边缘对组织进行凝血。平滑的远侧边缘用来对组织的更多目标部分进行凝血。当电源启动，电流通过夹臂104对夹臂104接触的组织进行凝血。上述的程序可重复直至达到期望的烧灼和/或凝血效果。
在完成期望的烧灼和/或凝血后，或者期望利用装置100的夹持方面，电源可断开并将夹臂104定位在待夹持的一部份组织的周围。一旦将待夹持的一部份组织定位在夹臂104之间，则夹臂104朝向闭合构型移动，因此组织被夹持于夹臂104之间。夹臂104在开放与闭合构型之间移动，直到夹持住期望的一部份组织。在一个特定的实施例中，在闭合构型中，藉由将控制件112朝近侧进一步拉动直到芯件142的近端160朝近侧移动而抵靠管106的连接突片132，使装置100的远侧部102随夹臂104展开。抵靠突片132的朝近侧力迫使突片132从衬套120的开口130脱离，从衬套120中释放管106。控制件112进一步朝近侧移动使芯件142分离，使得夹臂104的近端116被释放并与窗口138卡合，从而将夹臂104锁定在闭合构型中。芯件142的近侧部144朝近侧被拉出管106，从而使装置100的远侧部102与近侧部分离，并将装置在体内展开。
上述的展开程序是描述如何将装置100的远侧部展开的一个示例。远侧部102可利用多种不同的方式展开，取决于芯件142的构造和/或衬套120与管106之间的联接方式，只要展开程序能将管106从衬套120中释放，并同时将夹臂104锁定在闭合构型中即可。
根据一个替代实施例，如图2所示，装置100’基本与上述装置100相似，包括具有夹臂104’的远侧部102’，夹臂104’可滑移地容置在管106’之中，通过控制件112’使远侧部102’在开放构型与闭合构型之间移动。装置100’的使用方法基本与装置100相同。然而，管106'并非绝缘和/或由非导电材料形成，而是由导电材料形成，使得电能可以通过。例如，电能基本如上文关于装置100所述的那样通过控制件112'经由与管106'接触的芯件142'和/或夹臂104'传输到管106'。
与装置100相似，远侧部102’通过衬套120’可释放地联接于装置100’的近侧部110’的柔性件118’。然而，近侧部110’也包括非导电分离器162’定位于衬套120’与柔性件118’之间，以进一步保护柔性件118'免受电流影响。基本类似于上述装置100，可通过将柔性件118’中延伸的控制线112'的部分绝缘和/或用非导电护套158’覆盖部分的控制线112'，使柔性件118’免受电流影响。
如图3至4，根据示例性实施例的装置200基本相似于如上所述的装置100，包括一对夹臂204可在管206中在开放构型与闭合构型之间滑移。然而，并非通过控制件212令电流传输到夹臂204，而是通过导电或电容联接来激活经由夹臂204进行的烧灼和/或凝血。具体来说，导电线圈264围绕管206的外表面而延伸。导电线圈264可连接到装置200的近端处的电源，使得供电时，导电线圈264产生将电能传输到夹臂204的电场，使得夹臂204可以烧灼组织和/或以基本类似于装置100的方式对组织进行凝血，如上所述。由于夹臂204是利用导电线圈264激活，所以控制件212为绝缘和/或由非导电材料形成。
如图5至6所示，根据替代实施例的装置200'基本类似于装置200。然而，装置200'并非具有围绕管206’外部的导电线圈，而是具有围绕管206’内表面延伸的导电线圈264'。导电线圈264'产生用来激活可滑动地容置在管206'内的夹臂204'的电场。在另一个未示出的实施例中，导电线圈可嵌入管206'的壁内。
装置200、200’的使用方法基本与装置100相似。特别来说，夹臂204、204’可如上所述的用来进行消毒、凝血和/或夹持组织。
在不脱离本发明的精神和范围的条件下，可针对本发明的结构和方法做出变化。因此，本发明旨在包括本领域技术人员可设想到的本发明的修改和变化。

Claims (15)

1.一种治疗组织的装置，包括：
从近端朝远端纵向延伸的管，所述管包括延伸穿过所述管的通道，所述管可释放地与所述装置的近侧部联接；
夹臂，所述夹臂的近端可滑移地容置在所述管的所述通道中，从而使所述夹臂可在开放构型与闭合构型之间移动，在所述开放构型中所述夹臂的远端朝远侧延伸并越过所述管的远端而彼此分离，在所述闭合构型中通过所述管的内表面限制所述夹臂，从而使所述夹臂的远端朝彼此拉近；
联接于所述夹臂的芯件，所述芯件包括近侧部与远侧部，所述近侧部与所述远侧部可释放地彼此连接，因此当所述芯件经受预定负载时，所述近侧部和所述远侧部彼此分离；以及
与所述芯件连接的导电控制件，所述被连接件的近端与电源连接用来将电流传输到所述夹臂。
2.根据权利要求1所述的装置，其中所述装置的近侧部包括柔性件与位在所述柔性件的远端的衬套。
3.根据权利要求2所述的装置，其中所述柔性件与所述衬套通过非导电的元件而彼此隔开从而保护所述柔性件免受电流影响。
4.根据权利要求1至3中任一所述的装置，其中所述芯件的所述近侧部与远侧部通过可断开连接件而彼此连接。
5.根据权利要求1至4中任一所述的装置，其中所述管是绝缘的或是由非导电材料制成。
6.根据权利要求1至5中任一所述的装置，其中所述管是由导电材料制成。
7.根据权利要求1至6中任一所述的装置，其中所述控制件的一部分被绝缘，从而保护所述装置的近侧部。
8.根据权利要求1至7中任一所述的装置，其中所述夹臂的部分被绝缘从而提供电流到所述夹臂的期望部分。
9.根据权利要求1至8中任一所述的装置，其中所述芯件的所述近侧部包括限制突片用来卡合所述夹臂的近端，所述远侧部包括对齐突起用来卡合横向延伸穿过所述每个夹臂的相应切口。
10.根据权利要求1至9中任一所述的装置，其中所述夹臂的所述远端包括朝彼此横向延伸的尖锐齿，当通过所述夹臂接收电能时，所述尖锐齿用来烧灼夹在所述夹臂之间的组织。
11.根据权利要求1至10中任一所述的装置，其中当接收到电能时，所述夹臂的内表面被构造成对组织进行凝血。
12.一种夹持装置，包括：
近侧部，所述近侧部具有柔性件和衬套，所述柔性件从近端纵向延伸至远端，所述衬套连接到所述柔性件的所述远端；以及
可释放地联接至所述近侧部的远侧部，因此所述远侧部可从所述夹持装置展开，所述远侧部包括：
可释放地联接于所述衬套的管，所述管从近端纵向延伸至远端并包括延伸穿过所述管的通道；以及
夹臂，所述夹臂从可滑移地容置在所述管的所述通道中的近端而延伸，使得所述夹臂可在开放构型与闭合构型之间移动，在所述开放构型中所述夹臂的远端朝远侧延伸并越过所述管的远端而彼此分离，在所述闭合构型中通过所述管的内表面限制所述夹臂，从而使所述夹臂的远端朝彼此拉近；
联接至所述夹臂近端的芯件，所述芯件包括通过可断开连接件彼此连接的近侧部与远侧部，所述可断开连接件设计成在经受预定负荷时失效；以及
连接至所述芯件的导电控制线，所述被连接件的近端连接至电源用来传输电流至所述夹臂。
13.根据权利要求12所述的装置，进一步包括延伸覆盖所述控制线一部分的绝缘衬套。
14.根据权利要求12与13中任一所述的装置，其中所述夹臂远端包括侧向朝彼此延伸的尖锐齿。
15.根据权利要求12至14中任一所述的装置，其中所述夹臂的部分被绝缘。
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US10307202B2 (en) 2019-06-04
CN108289686B (zh) 2021-03-16
EP3359060A1 (en) 2018-08-15
JP2018534994A (ja) 2018-11-29
US20190247109A1 (en) 2019-08-15
WO2017095626A1 (en) 2017-06-08
US20170156785A1 (en) 2017-06-08
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