CN102018537A - 具有真空控制模块的活检系统 - Google Patents
具有真空控制模块的活检系统 Download PDFInfo
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Abstract
本发明公开一种具有真空控制模块的活检系统。该活检系统包括活检装置,该活检装置具有用于切割组织样本的平移切割器和真空控制模块。真空控制模块与活检装置分离。真空控制模块包括真空泵和真空罐,并且可由单手携带。真空罐和真空控制模块具有互补的端口,所述端口能够在真空罐插入到真空控制模块中时连接。互补的端口在真空控制模块中的真空泵和真空罐中的容器之间提供流体连通。活检装置可以通过罐与真空泵流体连通,而不需使用者将任何管与罐或泵单独连接。
Description
本申请是于2007年12月13日提交的题为“具有真空控制模块的活检系统”的国家申请200710307157.9的分案申请。
技术领域
本发明的一些实施方式整体上涉及用于从体内获得组织样本的活检装置,更具体而言,涉及一种包括轻型、便携式活检控制模块的活检系统。
背景技术
当通过检查、超声波、核磁共振扫描(MRI)、X射线成像等发现在患者的乳腺或其它区域中有可疑组织肿块时,为了确定该肿块是否包含癌细胞,需要进行活检手术以切下上述组织的一块或多块样品。可以使用开放式或经皮式方法进行活检。在活检领域,用来获得用于随后取样和/或试验的组织样本的医疗装置是公知的。例如,现已推向市场的商品名为MAMMOTOME的活检器械可以从EthiconEndo-Surgery公司商业获得,该活检器械用于获得乳腺活检样本。该装置利用真空的辅助插入到乳腺组织中,并且一次插入一般取回多块针芯活检样本。
以下专利文件公开了多种活检装置,其完整的披露内容通过引用包含在此:2001年8月14日公告的美国专利6273862;2001年5月15日公告的美国专利6231522;2001年5月8日公告的美国专利6228055;2000年9月19日公告的美国专利6120462;2000年7月11日公告的美国专利6086544;2000年6月20日公告的美国专利6077230;2000年1月25日公告的美国专利6017316;1999年12月28日公告的美国专利6007497;1999年11月9日公告的美国专利5980469;1999年10月12日公告的美国专利5964716;1999年7月27日公告的美国专利5928164;1998年7月7日公告的美国专利5775333;1998年6月23日公告的美国专利5769086;1997年7月22日公告的美国专利5649547;1996年6月18日公告的美国专利5526822;以及由Hibner等人提交的于2003年10月23日公开的美国专利申请2003/0199753。
一些真空辅助活检装置可以利用可再用控制模块,该控制模块包括真空泵和其它控制设备。这种真空控制模块可能相对较大且较重,并且可以安装在转轮或轮式平台上,从而能够将真空控制模块在手术区从一间病房移到另一间病房。
尽管已经制造和使用了多种活检系统,但相信没有人先于本发明人制造或使用如所附权利要求书中描述的活检系统。
发明内容
本发明具体公开了如下内容:
(1).一种活检系统,包括:
(a)活检装置,其包括:
(i)插管,
(ii)切割器,其被能够切割组织,和
(iii)一个或多个腔,所述腔用于连通流体;
(b)真空控制模块,其包括:
(i)真空泵,和
(ii)罐接收部分,其具有与所述真空泵流体连通的第一端口;
(c)罐,其能够与真空控制模块的罐接收部分接合,其中,所述罐包括:
(i)容器,其能够保持流体,和
(ii)第二端口,其与所述容器流体连通,其中,在罐与真空控制模块的罐接收部分接合时,所述第二端口能与真空控制模块的第一端口直接接合,以使所述容器和真空泵之间流体连通;以及
(d)与所述活检装置和罐连接的导管,其中,所述导管限定了导管腔,所述导管腔能够在罐的容器与活检装置的所述一个或多个腔中的至少一个之间提供流体连通。
(2).如第(1)项所述的活检系统,其中,所述切割器包括中空管,所述中空管限定所述一个或多个腔中的第一腔。
(3).如第(2)项所述的活检系统,其中,所述插管限定所述一个或多个腔中的第二腔,所述第二腔与第一腔平行。
(4).如第(1)项所述的活检系统,其中,所述第一端口具有凹形结构,其中所述第二端口具有凸形结构。
(5).如第(1)项所述的活检系统,其中,所述罐接收部分包括由真空控制模块限定的开口,所述开口的大小使得罐能通过开口插入。
(6).如第(1)项所述的活检系统,其中,所述罐还包括浮子,其中所述浮子能够响应于容器内流体达到一定水平而封闭所述第二端口。
(7).如第(1)项所述的活检系统,其中,所述真空控制模块还包括电源,所述导管还包括电缆,所述电缆能够将来自电源的电力传递到活检装置。
(8).如第(7)项所述的活检系统,其中,所述电缆和导管腔一体地形成于所述导管中。
(9).如第(7)项所述的活检系统,其中,所述真空控制模块还包括与电源相联的第一组触点,所述罐还包括与电缆相联的第二组触点,所述第一组触点和第二组触点能够在所述罐与真空控制模块的罐接收部分接合时接合,使电源和活检装置之间电连通。
(10).如第(1)项所述的活检系统,其中,所述真空控制模块能够由单手提起和搬运。
(11).如第(1)项所述的活检系统,其中,所述导管与罐是一整体,从而所述罐与导管进行整体包装。
(12).一种活检系统,包括:
活检装置,其具有用于切割组织样本的平移切割器;
真空控制模块,其与所述活检装置连通并独立于活检装置,所述真空控制模块包括真空泵和真空罐,真空控制模块能够向活检装置提供电力和真空,所述真空控制模块可由单手携带。
(13).如第(12)项所述的活检系统,其中,所述真空控制模块的重量小于约40磅。
(14).如第(12)项所述的活检系统,其中,所述真空控制模块的高度小于约1.5英尺,宽度小于约1.5英尺,深度小于约1.5英尺。
(15).如第(12)项所述的活检系统,其中,所述真空控制模块通过单个管缆向活检装置提供电力、真空和盐水。
(16).如第(12)项所述的活检系统,其中,所述活检装置包括至少一个与由真空控制模块提供的真空连通的阀。
(17).如第(12)项所述的活检系统,其中,所述活检装置包括阀,所述阀具有用于与由真空控制模块提供的真空连通的入口,并且所述阀的操作位置是基于平移切割器的纵向位置。
(18).如第(12)项所述的活检系统,其中,所述活检装置包括第一阀和第二阀,其中,所述第一阀包括:第一入口,其用于与真空源连通;第二入口,其用于与盐水源连通;以及至少一个出口,所述第二阀具有与第一阀的出口连通的入口。
(19).如第(12)项所述的活检系统,其中,所述真空罐能够插入到真空控制模块的一部分中,其中,所述真空罐包括第一端口和容器,所述真空控制模块包括第二端口,所述第一端口和第二端口能够在真空罐插入到真空控制模块的一部分中时连接,其中第一端口和第二端口的连接使得容器和真空泵之间流体连通。
(20).一种用于与活检装置一起使用的真空系统,所述真空系统包括:
(a)真空控制模块,其中,所述真空控制模块包括:
(i)真空泵,和
(ii)罐接收部分,其中,所述罐接收部分具有与真空泵流体连通的第一端口;
(b)罐,其中,所述罐被构造成与真空控制模块的罐接收部分接合,其中所述罐包括:
(i)容器,其中,所述容器能够保持流体,和
(ii)第二端口,其中,所述第二端口与容器流体连通,在罐与真空控制模块的罐接收部分接合时,所述第二端口能够直接与真空控制模块的第一端口接合,使得容器与真空泵之间流体连通;
(c)第一导管,其用于使来自容器的真空通向活检装置;以及
(d)第二导管,其用于使盐水通向活检装置,其中,所述第二导管与第一导管基本上平行。
附图说明
尽管本说明书通过权利要求书具体指出并清楚地请求保护本发明,但结合附图,通过参考以下描述将能够更好地理解本发明,其中:
图1是根据本发明的一种实施方式的活检系统的示意图;
图1A是具有真空腔和切割腔的组织刺穿插管的远侧部分的示意图,示出了切割腔中切割器的远侧部分;
图1B是随着切割器在切割腔内相对于组织接收孔前进和回缩时真空腔内具有的真空度的示意图;
图2是图1中示出的真空控制模块的某些部件的分解示意图;
图3是能够用于图1中活检系统的真空罐的示意图;
图4是多腔电缆接口和真空罐盖的接口的示意图;
图5是包括手柄和铰接盖的控制模块的示意图;
图5A示出了定位在图5中控制模块背面上的USB端口;
图6示出了能够相对于插入到控制模块上的USB端口中的USB装置执行的多个步骤;
图7示出了可以用于活检系统的气动回路;以及
图8示出了能够用于控制活检系统中的活检装置的多种控制状态。
具体实施方式
图1示出了根据本发明一种实施方式的活检系统。本示例的活检系统包括:活检装置10,其具有用于切割组织样本的平移切割器120;真空控制模块5000;和管缆200,其从活检装置10延伸到控制模块5000。管缆200可以是电缆形式的,具有多个用于向活检装置10提供电源、真空、气动装置、液压系统或盐水中的一种或多种的腔。活检装置10可以是例如适用于超声成像的手持式装置10A,或者替代地,可以是安装在立体定向台或X射线台上的立体定向装置10B。真空控制模块5000可以是相对较轻的便携式设备,具有光滑成形的外壳5100和提把5015。一个人用一只手可以容易地提起并移动本示例的轻质控制模块5000。本示例的多腔管缆200在活检装置10和控制模块5000之间提供单线连接,消除了具有多个从活检装置10延伸的电动、盐水、气动、液压和/或真空管线的复杂性。
如上所述并如图1所示,活检装置10可以是适用于超声成像的手持式活检装置10A。该活检装置10A可以包括可再用的机座130和能够从机座130上拆卸的可置换探头设备160。机座130和探头160共同形成能够舒适地单手握持并操作的手持件。活检装置10B可以包括可置换探头设备163和可再用的立体定向机座133,该立体定向机座133具有用于将活检装置的组织刺穿部分发射到组织中的击发机构。该击发机构可以是电动的(例如电机驱动),并且可以包括:按钮150,通过作用该按钮150以致动击发机构;以及击发构件152,其被构造成使探头160的至少一部分发射到组织中。击发机构可以采用任何适当的结构,只要具有击发机构即可。立体定向机座133能够被构造用来可操作地安装在立体定向X射线台上。当然,可以将活检装置10A和活检装置10B可选择性地用于多种其它装置或构造中。
本示例的探头设备160和163包括向远侧延伸的组织刺穿部分,例如从探头160向远侧延伸的插管100。该插管100可以包括远侧组织刺穿尖端110和位于尖端110近侧与尖端110间隔开的组织接收孔114。插管100也可以包括切割腔104和真空腔108,其中在腔104与腔108之间提供流体连通的通路107和109位于插管100的远侧部(图1A)。可以将插管100插入到待取样的组织肿块中或使其接近所述组织肿块,并且可操作活检装置10在一次将插管100插入到组织中时获得多块被切割的组织样本。
将插管100插入到组织中,然后通过在插管100中平移的管状切割器120的尖锐的远端122(图1A)来切割被拉进孔114内的组织。可以施加真空,使其沿轴向通过切割器120并进入真空腔108中,以辅助将组织拉进孔114内。图1B通过图解示出了随着切割器120相对于孔114平移时真空腔108中具有的可变真空度。探头设备160和163也可以包括组织存储组件2000,其能够布置在探头设备160、163的近端或其它位置。组织存储组件2000可用于存储多块组织样本,所述样本通过切割器在插管100内的平移来切割,并从近侧穿过中空切割器120而转移到组织存储组件2000中。
本示例的探头设备160和163中的每一个还包括布置在插管100附近的灯140。仅作为示例,灯140可以包括LED或其它光源,并且可以被构造成至少局部照亮插管100插入的部位。探头163还包括遥控指轮156,可以旋转该指轮156以使探头163的插管100相对于其剩余部分旋转。鉴于这里的教导,本领域普通技术人员可以想到用于产生上述旋转的合适的机构。当然,可以根据需要对探头160、163以及机座130、133进行各种改变和变型。
本示例的真空控制模块5000可以由单手携带,并且其重量可以不超过约40磅,在一种实施方式中其重量小于约25磅。替代地,真空控制模块5000可以具有任何适当的重量。如图1所示,控制模块5000的手柄5015从设备的上部向上延伸,手柄5015是控制模块5000的最上方部件。本示例真空控制模块5000可以具有的最大外部尺寸为宽W、深D和高H,各尺寸均小于约1.5英尺。替代地,真空控制模块5000可具有任何适合的尺寸。本示例的真空控制模块5000还包括用于接收来自标准电源插座的电力的标准电源线。
图2示出了本示例控制模块5000的各部件。控制模块5000可以包括:内部铝质(或其它适当的金属)底架5110,该底架5110可以直接或间接地支撑真空泵4010;AC/DC电源5073;和微处理机控制板5040。适当的电源5073可以包括由Condor D.C.Power Supplies ofOxnard,California生产的型号为GPFC250 Commercial/GPFM250Medical 250的250瓦电源。替代地,也可以使用任何其它适当的电源5073。适当的真空泵4010可以包括2头膜片泵,其最大流速小于约每分钟18升,其供应的最大真空量约为25.1英寸汞柱(InchHg.)。替代地,真空泵4010可以具有任何其它适当的部件和性质。仅作为示例,一个适当的真空泵4010可以是从Reitschle Thomas,Thomas Products Division of Sheboygan,Wisconsin处获得的型号为7006ZVDP-2,3E的膜片泵。
控制模块5000也可以包括布置在控制模块5000的外表面上或其它位置(例如控制模块5000的外部等)上的LCD显示器5050,或其它类型的显示器。仅作为示例,显示器5050可以包括背光源、彩色LCD显示器。替代地,可以使用任何其它类型的显示器5050,或不设置显示器5050。在控制模块5000上靠近显示器5050也可以设置键盘5080。键盘5080可以包括电容式开关或其它输入装置,并且可以用于向控制模块5000输入指令或与其互相作用。显示器5050可以显示操作条件、菜单或其它信息,因此显示器5050和键盘5080共同提供了用户界面。当然,可以替代地以任何适当的方式使用任何其它适当的部件来提供用户界面。
在本示例中,控制模块还包括用以接收现成盐水包5300的附加组件5200。该附加组件5200与柔性电路5202相连接,并用以感测盐水包5300的重量。具体而言,控制模块5000可以被构造成当附加组件5200感应到没有重量或重量不足,也就是表明没有盐水包5300或盐水包5300包含不足量的盐水时阻止操作活检装置10。此外或替代地,控制模块5000可以被构造成例如经由显示器5050来告知用户盐水包5300与附加组件5200未连接或盐水包5300包含不足量的盐水。替代地,可以任何其它适当的方式使用来自附加组件5200的数据,或者可以完全省略附加组件5200。
本示例的真空控制模块5000可以包括真空罐4030,该真空罐4030可拆卸地容纳于设置在控制模块5000的基本上面朝上的外表面中的开口5030中。真空罐4030可以用作用于活检真空电路的真空“电容器”,并且其容积可以小于约300立方厘米。更具体而言,真空罐4030的容积可以是约200cc至250cc。替代地,真空罐4030可具有任何其它适当的容量或性质。
参考图3,本示例的管缆200可以包括多个腔,可以包括第一腔202,其用于将来自真空泵4010的真空输送至活检装置10;第二腔204,其用于一个或多个传送电导体,所述电导体用来将电力和控制信号从控制模块5000输送至活检装置10;以及第三腔206,其用于输送盐水。替代地,管缆200可以具有任何其它适当数量或类型的腔。在另一变型中,一个或多个腔202、204、206以独立的导管或电缆的形式提供,而不是结合在单一的管缆200中。管缆200的近端可以包括连接终端210。管缆200的远端可以容纳于活检装置10的可置换部分中,例如探头160或探头163中,从而电力和控制信号通过可置换探头160导向,然后到达机座130。一个或多个控制器(例如控制按钮170、172、174等)可以定位在可再用机座130上。替代地,管缆200的远端或其一部分可以容纳在机座130中或其它位置。同样,控制器除了可以定位在机座130上以外,还可以定位在探头160、163上,或者代替定位在机座130上的控制器将其定位在探头160、163上。
本示例的真空罐4030可以包括杯形或容器形本体部分4032和盖4034。真空罐4030插入到控制模块5000的朝上面向的外表面中的开口5030中。真空罐4030可支撑在至少部分围绕开口5030延伸的盖5031上。当然,有多种可以用来构造真空罐4030以及将真空罐4030和控制模块5000连接的替代方式。
在本示例中,真空罐4030的本体部分4032包括与真空罐4030内部连通的凸形真空端口4033。当真空罐4030插入到开口5030中时,端口4033可以与设置在盖5031开口中的凹形真空端口5033密封接合。在其它变型中,控制模块5000的盖5031或其它部分可以包括凸形真空端口4033,而真空罐4030具有互补的凹形真空孔口5033。在本示例中,真空端口5033可与柔性软管、管或其它导管连接,所述柔性软管、管或其它导管与布置在控制模块5000中的真空泵4010的出口连通。因此,在本示例中,当真空罐4030插入到开口5030中时,自真空泵4010到真空罐4030内部便建立了真空连接。
本示例的盖4034适于接收设置在管缆200近端的连接终端210。盖4034可以包括上部的第一盖部分4036和下部的第二盖部分4038。连接终端210可以容纳于第一和第二盖部分4036、4038之间,并且两个盖部分4036、4038连接在一起(例如通过咬合、粘合或任何其它适合的方式)。位于盖部分4036、4038之间的终端210的位置可通过下部盖部分上的定位销212来确定,定位销212与设置在终端210周边上的对应的导向孔214配合。替代地,如果需要,任何其它适当的结构或特征都可以用以确定位于盖部分4036、4038之间的终端210的位置。当然,盖4034可以由单件形成,而不是两个盖部分4036、4038,并且管缆200可以任何其它适当的方式相对于盖4034固定。多腔管缆200和真空罐4030可以是分离式可置换件,或是整体式可置换件。
如图1、3和4所示,本示例的连接终端210提供了多触点电连接器223,当终端210设置在盖4034上时电连接器223自盖4034面向外部。控制模块5000包括配对多触点电连接器5023。多触点电连接器5023设置在控制模块5000的开口5030附近,使得当真空罐4030位于开口5030中时,通过触点223和5023在控制模块5000和多腔管缆200之间建立电接触。然而,可以理解的是,可以利用多种替代结构和技术在控制模块5000和管缆200之间提供电接触。
参考图3和4,连接终端210还可包括从连接终端210的底部表面向下延伸的凸形真空端口227。真空端口227与通过管缆200中的真空腔202连通。当终端210布置在盖4034上的盖部分4036和4038之间时,真空端口227穿过下部盖部分4038中的开口4037延伸,以与真空罐4030内部连通。替代地,可以利用任何其它适当的结构或技术将真空腔202与真空罐4030内部连通。
因此,在本示例中,真空罐4030、终端210和控制模块5000被构造成使得当真空罐4030放置在控制模块5000的开口5030中时在活检装置10和真空控制模块5000之间提供电连接和真空连通。换言之,活检装置10和真空控制模块5000之间的流体连通和电连接仅通过将真空罐4030插入到开口5030中来实现,从而使用者不必在真空罐4030插入到开口5030中之前或之后建立附加的管或电缆连接(例如与真空罐4030的管连接)等。这里所用的术语“流体”应当理解为包括真空、压缩空气、大气、液体(例如盐水、血液等)等,不管固体物质(例如组织样本或颗粒等)是否随其输送。
仍参考图3和4,可以将浮子4063布置在真空罐4030中。如果真空罐中的流体蓄积到容许水平之上,那么可以操作浮子4063来封闭真空端口4033。如果需要的话,可以在真空端口5033处设置包括过滤垫5037和过滤垫罩5038的过滤器组件5035。当然,和这里描述的其它部件一样,浮子4063、过滤器组件5035、过滤垫5037和过滤垫罩5038都只是可选择的,根据需要可以对它们进行修改、替换、补充或省略。
图5是包括铰接盖5600的控制模块5000的一种实施方式的示意图。铰接盖5600盖住存储腔5610,存储腔5610类似于图2所示控制模块的组织存储舱5620。存储腔5610的尺寸可以适于存储一个或多个活检装置机座130。如果需要的话,可以在腔5610附近或内部设置多个UV光源5612(仅示出一个)。光源5612可以被构造成当铰接盖5600关闭时其“接通”(当铰接盖5600打开时光源5612“断开”),并且可以用于对存储在存储腔5610中的部件进行消毒或灭菌。在其它实施方式中,除了具有光源5612之外或者代替它,也包括其它部件、特征或装置用于对存储在存储腔5610中的一个或多个部件进行消毒或灭菌。在另外一些实施方式中,不包括用于对部件进行消毒或灭菌的特征。同样,在控制模块5000的一些变型中完全没有存储腔5610。
参考图5A,可以在控制模块5000的外表面上设置一个或多个通用串行总线(USB)端口5700。替代地,可以在控制模块5000上设置任何其它类型的端口(例如SD卡槽、以太网端口、串行连接端口、专用连接端口等)。图6示出了当USB存储装置(未示出)经由端口5700与控制模块5000连接时可以采用的操作步骤的顺序流程图。根据USB存储装置的内容,可以确定动作过程。例如,根据USB存储装置的内容,控制模块微处理机控制器可以将真空控制模块数据(例如使用时间、操作状态、首次使用或首次服务日期等)写入USB存储装置。控制微处理机控制器也可以将活检装置数据(例如使用时间、操作状态、首次使用或首次服务日期)写入USB存储装置。替代地,真空控制模块5000可以从USB存储装置、真空模块的程序重调操作和/或活检装置10的程序重调操作中读出新的校准信息、软件或软件更新等。替代地,通过端口5700或一些其它方式可以使计算机(例如台式或便携式PC)、或网络(例如因特网)与控制模块5000连接。
图7是可以用于本示例活检装置10和真空控制模块5000的气动配置的示意图。图8示出了可以用于控制活检装置10的多种控制状态。
如图7所示,本示例的控制模块5000包括设置在气动回路中的真空泵4010、调节器4020和真空罐4030。主控制阀4060和盐水/真空阀4080示意性地示出为位于可置换探头160中。
由真空泵4010提供的真空可以经由管缆200的真空腔202通向可置换探头160,以向切割器120和切割腔104供应真空。供应所述真空可以不装设阀,使得当操作真空泵4010时,向插管100的切割器120内部和切割腔104供应真空总是处于“接通”状态。替代地,可以在探头160、真空罐4030、控制模块5000中和/或其它位置处设置一个或多个阀或相似的部件。由管缆200提供的真空也可通过两个阀4060和4080向真空腔108提供。阀4080可以是二位三通阀,具有两个输入口。一个输入口可以连接到真空源上,另一个输入口可以连接到盐水源4016上(或替代地通过过滤器4018和大气压力相通)。阀4080的输出口与主阀4060的输入口连通。鉴于这里的教导,本领域普通技术人员很容易想到端口的其它适当的构造和连接。
阀4080的操作位置可以被构造成对应于切割器120的位置,例如通过使切割器120穿过阀4080延伸,使得切割器120在阀体内的位置能够确定阀口的操作状态(打开或关闭)。当切割器120向近侧回缩时(例如使得组织接收孔114打开),阀4080和主控制阀4060真空连通。当切割器120向远侧推进时(例如使得组织接收孔114关闭),阀4080和主控制阀4060盐水连通。替代地,如果没有盐水或者不需要盐水,那么阀4080通过过滤器4018与主控制阀4060大气连通。阀4060可以通过受微处理机控制的电机、通过与切割器120的机械连接件或通过其它方式来致动。阀4080可以在一处位置进行弹簧加载,切割器120的运动(例如切割器120运动到远端位置)可以用于改变阀的操作位置。替代地,可以任何其它适当的方式将阀4080的操作位置构造成对应于切割器120的位置。此外,阀4080可以被构造成使其操作位置不一定要与切割器120的位置对应。
主控制阀4060可以是三位三通阀。一个输入口可以连接到阀4080的输出口上。第二输入口可以与过滤的大气相通。阀4060的输出口可以连接到插管100的真空腔108的近端上。阀4060的阀位可以由活检装置10的操作者使用一个或多个用户控制接口(例如图8中所列的控制按钮170、172、174)或任何其它接口来控制。控制按钮170、172、174可以定位在活检装置10的本体上的任何便利的位置处,包括例如定位在手持件130上或其它位置。阀4060可以由螺线管、电机来致动,或通过与切割器120之间的连接件来致动,或以其它方式致动。
参考图8,活检装置10的“就绪状态”对应于切割器120被推进到其最远侧位置并且组织接收孔114关闭。在就绪状态,阀4080和主控制阀4060盐水连通,并且主控制阀被设置用来封闭(关闭)它的其它口,包括与真空腔108连通的输出口。在就绪状态时,通过关闭通向侧腔108的口,通过装置的气流量可以降至最低,这将允许泵4010更容易地维持真空罐4030在所需的真空度。
在本示例中,当操作者按下“取样”按钮170时,切割器电机被致动以使切割器120向近侧回缩。当切割器回缩时,阀4080改变位置以与主控制阀4060真空连通。同时,主控制阀改变位置以与真空腔108真空连通。组织接收孔114打开时,来自真空泵4010的真空施加到切割器120(例如通过组织存储组件2000)和切割腔104(通过切割器120),以及真空腔108(通过阀4080和4060)上。真空施加到切割腔104和真空腔108有助于将组织脱出到插管100的孔114中。
在维持这种真空状态一秒或更长时间以确保组织被脱出到孔114中之后,切割器120向远侧推进(并同时旋转)以关闭孔114并切割在中空切割器120远侧部分中的组织样本。当切割器120向远侧推进时,切割器120可以接触或用其他方式致动阀4080来改变阀的位置以与主控制阀4060盐水连通。同样,当切割器120推进时,可以使用微处理机改变主控制阀4060的位置以与真空腔108过滤大气连通,真空腔108又通过通道107、109与设置在中空切割器120的远侧部中的切割组织样本的远侧面连通。组织样本的远侧面上的大气在组织样本上施加向近侧的推力,而在切割器120中提供的真空(通过组织存储组件2000)在切割的组织样本上施加指向近侧的拉力。施加在组织样本上指向近侧的力使组织样本通过中空切割器120输送到组织存储组件2000中。当然,任何其它适当的结构或技术都可用于获得组织样本,并使其与组织存储组件2000连通。
在一种替代实施方式中,微处理机可用于改变主控制阀4060的位置,从而使主控制阀首先与真空腔108盐水连通预定的一段时间,然后改变阀的位置以与腔108大气连通。因此,定量的盐水可以通过通道107、109输送到中空切割器120的远端,由此有助于向近侧移动切割的组织样本通过中空切割器120到达组织存储组件2000。在预定的一段时间(例如一秒或几秒)之后,可以通过编程使控制系统返回就绪状态。
在就绪状态(例如在操作“取样”按钮170以切割组织之后)时,为了引导微处理机控制器使切割器120作轻微往复运动,以将孔114打开和关闭一英寸的若干分之几(例如0.2英寸),或任何适当的程度,活检装置操作者可以按下“清除探头”按钮172。切割器120的往复运动可以有效地移组织样本或释放样本,使得样本可以自由地通过中空切割器120。当切割器120作往复运动时,真空控制阀4060可以复位以与真空腔108盐水连通,并通过通道107、109在组织样本的远侧面上施加推力。在预定的一段时间之后,微处理机可以使气动系统返回就绪状态。
当装置处于将药物或组织标记物插入到待取样的组织或者已经或将要取出组织样本的部位中的就绪状态时,操作者可以按下和释放“吸出/插入”按钮174。在本示例中,当按钮174按下时,切割器120向近侧移动以打开孔114。主控制阀4060的位置改变以与真空腔108大气连通。按下“吸出/插入”按钮174也关闭真空(例如通过关闭真空泵4010或打开调节器4020以使真空泵4010出口与大气相通等)。组织标记施用器(或药物)可以通过中空切割器120例如通过组织存储组件2000或其它方式输送到插管100的近端内,然后通过插管100中的开口孔114配置标记(或药物)。配置标记或药物之后,用户可以按下任何按钮,使切割器120可以返回到主控制阀4060朝上定位的就绪状态。
操作者可以按下和保持“吸出/插入”按钮174以吸出孔114附近的流体。在本示例中,当操作者按下按钮174时,切割器120向近侧移动以打开孔114。切割器在近侧定位时,阀4080和主控制阀4060真空连通,并且设置主控制阀4060与真空腔108真空连通。因此,将真空施加到腔108和切割腔104中(因为在本示例中当真空泵4010操作时,真空连续地通过切割器120向腔104供应)。供应给腔104和腔108的真空吸出孔114附近的所有液体。当释放吸出/插入按钮174时,气动系统被控制返回就绪状态。切割器120被推进以关闭孔114。在本示例中,当切割器120被推进时,主控制阀4060被定位成与真空腔108过滤大气连通。一旦关闭穿刺口孔114,定位主控制阀4060以关闭其所有的口,达到就绪状态。对于这里描述的其它操作顺序,前述操作顺序仅为示例性的,除了这些在这里明确描述的之外或者代替它们,可以采用任何其它适当的操作顺序。
为了适应活检装置10在操作室内的运动,或由于控制模块5000在磁共振成像环境中的位置受到限制,从容纳真空泵4010的控制模块5000到活检装置10的管缆200的长度可以相对较长(在一些情况下是20英尺或更长)。当然,管缆200可以具有任意所需长度。在本示例中,当组织孔114打开时,管缆200中的真空管道可以被认为是需要通过真空泵4010和真空罐4030供应或维持流量的重要部分。将盐水真空阀4080和主控制阀4060设置在真空管道的远端(与活检装置10关联的端部)而不是在活检真空控制装置5000中,这意味着可以使用更小的真空泵4010和更小的真空罐4030。在一些常规的活检装置中,可以在包括真空泵的控制装置中装设阀,控制装置由于其重量和尺寸可以被安装在轮子上。在图2-4中,阀4060和4080如图所示布置在活检装置10中。阀可以布置在包括插管100和切割器120的可置换探头部分160、163中,和/或布置在活检装置10的不可置换(例如在机座130中)部分中。这样布置阀可以允许使用流速大约为每分钟18公升的重量相对较低的膜片真空泵4010,相比之下,用常规方法布置泵和阀所需的流速大于每分钟80公升。当然,可以使用具有任意所需特性的任何所需的真空泵。
同样,真空罐4030可以相对较小,其容积小于大约300立方厘米,相比之下,常规的真空罐的存储容量为1200立方厘米或更大。因此,可以使用相对较轻、手提式真空控制模块5000。真空控制模块5000(图1、2和5)的重量可以小于25磅,可以单手搬运,并且其高度、宽度和长度都小于约1.5英尺。替代地,真空罐4030和控制模块5000可以具有任何其它适当的容积、尺寸、重量或其它特性。
根据需要,可以使用脚踏板(未示出)或遥控键盘(未示出)直接向活检装置10提供控制输入或指令和/或例如通过连接器180向真空控制模块5000提供控制输入或指令。脚踏板和遥控键盘可以系栓在一起(例如使用一根或多根从踏板/键盘延伸到真空控制模块5000的导线等)。替代地,在脚踏板/键盘和控制模块5000和/或活检装置10之间可以采用“无线”通信。例如,可利用无线“蓝牙”通信和关联的硬件和软件向真空控制模块5000和/或活检装置10提供无线控制信号,无需用于信号发送和接收的“视线”。替代地,可以利用红外发射器和接受器来发送和接收控制信号。鉴于这里的教导,可在活检系统的部件之间(例如脚踏板/键盘和控制模块5000之间)建立通信的其它方式,不管是有线、无线或其它对于本领域普通技术人员来说都是可以想到的。
尽管在这里示出并描述了本发明的优选实施方式,但本领域的技术人员清楚地了解,这些实施方式仅作为示例提供。在不脱离所附权利要求书的精神和范围的条件下,本领域技术人员能够想到多种变型、改变和替换。此外,每一个与本发明有关的元件都可以被替代地描述为用于执行该元件功能的方式。
Claims (9)
1.一种活检系统,包括:
插管,所述插管具有封闭的组织穿刺远端和与所述封闭的远端向近侧隔开的组织接收端口,所述插管从所述探头延伸;
切割器,所述切割器具有切割器腔,所述切割器能够相对于所述插管的组织接收开口移动,以便撕裂组织;
布置在所述探头上的第一阀,其中所述切割器的至少一部分延伸穿过所述第一阀,使得所述切割器在所述阀内的位置确定所述第一阀的至少一部分的操作状态;以及
其中所述第一阀能够操作,以便在所述切割器位于远侧位置时连通盐水。
2.根据权利要求1所述的活检系统,其中所述活检探头包括与所述第一阀分开的第二阀。
3.根据权利要求2所述的活检系统,其中所述第一阀的输出端口与所述第二阀的入口端口连通。
4.根据权利要求1所述的活检系统,其中所述切割器在阀主体内的位置能够将盐水源与第二阀连通。
5.根据权利要求2所述的活检系统,其中所述切割器向近侧缩回使得所述第一阀操作,以便将真空连通到所述第二阀。
6.一种手持式活检装置,包括:
手持件,所述手持件的尺寸和形状能够通过单手抓握和操纵,而不借助于外部支撑件的帮助;
插管,所述插管从所述手持件的远端延伸,所述插管具有封闭的组织穿刺远端和与所述封闭的远端向近侧隔开的组织接收端口;
切割器,所述切割器具有切割器腔,所述切割器能够相对于所述插管的组织接收开口移动,以便撕裂组织;以及
第一阀,所述第一阀具有布置在所述手持件内的阀壳体;
控制阀;
其中所述切割器的至少一部分延伸穿过所述第一阀壳体;以及
其中所述切割器能够在所述第一阀壳体内运动,以便将真空连通到所述控制阀。
7.根据权利要求6所述的手持式活检装置,还包括组织存储组件。
8.根据权利要求7所述的手持式活检装置,其中所述组织存储组件被布置在所述手持件的近端。
9.根据权利要求7所述的手持式活检装置,其中所述手持件经由所述组织存储组件将真空连通到所述切割器。
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- 2007-11-20 US US11/942,764 patent/US7938786B2/en active Active
- 2007-12-11 CN CN201710020400.2A patent/CN106974679A/zh active Pending
- 2007-12-11 CN CN2007800504482A patent/CN101641052B/zh active Active
- 2007-12-12 DE DE602007007426T patent/DE602007007426D1/de active Active
- 2007-12-12 ES ES07254806T patent/ES2345681T3/es active Active
- 2007-12-13 CN CN2010106174511A patent/CN102018537A/zh active Pending
Cited By (4)
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US11179141B2 (en) | 2006-12-13 | 2021-11-23 | Devicor Medical Products, Inc. | Biopsy system |
CN104703549A (zh) * | 2012-08-13 | 2015-06-10 | 德威科医疗产品公司 | 活组织检查系统 |
CN104703549B (zh) * | 2012-08-13 | 2017-10-13 | 德威科医疗产品公司 | 活组织检查系统 |
US20200345335A1 (en) * | 2017-11-30 | 2020-11-05 | C. R. Bard, Inc. | Sample container and coaxial introducer cannula for a biopsy apparatus |
Also Published As
Publication number | Publication date |
---|---|
US20080228103A1 (en) | 2008-09-18 |
US7938786B2 (en) | 2011-05-10 |
CN106974679A (zh) | 2017-07-25 |
CN101641052B (zh) | 2013-01-02 |
CN101641052A (zh) | 2010-02-03 |
DE602007007426D1 (de) | 2010-08-12 |
ES2345681T3 (es) | 2010-09-29 |
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