CN101095619A - 用于组织穿透和止血的能量活检装置 - Google Patents

用于组织穿透和止血的能量活检装置 Download PDF

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CN101095619A
CN101095619A CNA2007101290035A CN200710129003A CN101095619A CN 101095619 A CN101095619 A CN 101095619A CN A2007101290035 A CNA2007101290035 A CN A2007101290035A CN 200710129003 A CN200710129003 A CN 200710129003A CN 101095619 A CN101095619 A CN 101095619A
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biopsy apparatus
vibrating mass
tissue
biopsy
inner sleeve
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CN101095619B (zh
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G·M·蒙森
J·A·希布纳
F·B·斯图莱恩
R·F·小韦克尔
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320069—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for ablating tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/32007—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with suction or vacuum means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320088—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath

Abstract

一种具有侧面组织进入口的活组织检查系统，包括基于能量的组织穿透系统，该组织穿透系统能够有利地穿透硬肿瘤、改善止血以及提供更大程度的组织访问。基于能量的组织穿透系统具有可拆卸地设置在活组织检查系统中的振动部件，以及从活组织检查系统延伸的振动部件的远侧尖端，其用于组织穿透。套管位于振动部件和侧面进入口之间，以防止组织穿过侧面进入口与振动部件接触。

Description

用于组织穿透和止血的能量活检装置
技术领域
本发明整体上涉及影像辅助的组织取样方法，更具体地说，涉及改进的活组织检查探针，其具有基于能量的组织穿透系统，以穿刺硬组织、移除病变、改善止血以及提供更大程度的组织访问(access)。
背景技术
针芯活组织检查装置已经与影像技术结合来更好地定位乳房组织中的病变。Ethicon Endo-Surgery，Inc.提供了一种这样的商业化产品，商标名称为MAMMOTOMETM。这种装置的例子在1996年6月18日授权给Burbank等人的美国专利No.5,526,822中进行了描述，该专利通过引用并入本文。它的手柄接收来自远程控制模块的机械能量和电能量以及真空助力，该控制模块远离磁共振影像(MRI)机器的强磁场。
从这篇专利中可以看出，该器械是一种图像引导、经皮穿刺的乳房活组织检查器械。它为真空助力式，并且获取组织样品步骤中的一些步骤已经实现了自动化。在将组织从身体上切下之前，医生使用这种装置“动态地”捕获(使用真空)该组织。这允许对不同硬度的组织进行取样。另外，使用开放的边孔，避免刺入病变中的必要，后者可能会推开组织。边孔可以围绕探针的纵向轴线旋转，从而允许获取多个组织样品而不需要重新定位探针。这些特征允许对大的病变进行取样，并完全切除小的病变。手持式乳房活组织检查器械还可以允许医生手动执行组织穿透和探针放置。
对乳房的组织穿透使用乳房活组织检查器械远端处的外科针刀(surgical sharp)实现。外科针刀切割并进入组织，且穿透力很大，尤其是在试图穿透硬的或者高密度的病变时。如果乳房活组织检查装置使用外科针刀之外的装置来建立其插入的通道，能够减小插入力，并且高密度的病变也能被穿透而不会被推开。使用能量输送手段如超生波、RF、加热器以及激光器来开设通道、切割组织以及提供减小的穿透力。能量输送手段还能够提供改善的止血，当与活组织检查系统如上述的活组织检查系统结合时，当应用于其它活组织检查方法时，比如前列腺肾脏、肝脏、肺脏、子宫等，能提供有用的优点。
作为例子，Eastabrook等人的美国专利No.6,274,963公开了一种超声波手柄或手持件，其可以用于穿透、切割和凝固组织，该专利公开的内容通过引用全部并入本文。
另外，一些乳房病变可以位于患者的不同部位，比如肋骨附近。通过使用能量输送装置结合活组织检查系统，能够减小外科针刀的长度，为困难的外科部位提供更大的访问范围。另外，位于远侧尖端处的能量输送装置能够用来消融或者烧灼病变组织，而不是将其除去。因此，迫切需要一种活组织检查系统，该系统具有减小的穿透力、改进的组织病变穿透、更好的组织访问、手术室中无需外科针刀以及改善的止血能力。
发明内容
本发明通过提供一种活组织检查系统来克服现有技术中的上述以及其它缺陷，该活组织检查系统包括基于能量的组织穿透系统，该组织穿透系统除去了外科针刀，减小了组织穿透力，能够穿透高密度的或者硬的肿瘤，改进对困难外科部位的访问，提供改善的止血、烧灼或者消融组织，并且能够提供对乳房以外的身体组织进行活组织检查的有用特征。使用这种系统，医生能够具有真空辅助针芯活组织检查系统的全部功能，所具有的增加的额外能量能提高该系统的使用性，并为医生提供益处。
本发明具体涉及：
(1)一种用于穿透和移除组织的活组织检查装置，包括：
具有侧面组织接收孔的外部插管；
振动部件，其设置在所述外部插管内且具有在所述外部插管的远端露出的远侧尖端，所述远侧尖端用于穿透组织；以及
在所述振动部件和所述插管之间的内部套管，所述内部套管暴露所述振动部件的所述远侧尖端，并阻挡所述外部插管的所述侧面组织接收孔。
(2)根据第(1)项所述的活组织检查装置，其中，所述振动部件以超声波频率进行振动。
(3)根据第(1)项所述的活组织检查装置，其中，所述振动部件和所述内部套管具有至少一个在它们之间延伸的隔离元件，操作所述隔离元件能够将所述振动部件与所述内部套管隔离开。
(4)根据第(1)项所述的活组织检查装置，其中，所述振动部件和所述内部套管可以插入所述外部插管内并且可以从所述外部插管内取出，所述振动部件和所述内部套管在插入和取出期间相对于彼此的位置保持不变。
(5)根据第(1)项所述的活组织检查装置，其中，所述内部套管可拆卸地连接在所述振动部件周围。
(6)根据第(1)项所述的活组织检查装置，其中，所述内部套管的至少一部分横截面为弓形。
(7)根据第(1)项所述的活组织检查装置，其中，所述远侧尖端具有至少一个表面，所述至少一个表面从下面的组中选择：凹面、凸面、斜角面、弓形面、平面、球面、锥形面以及尖锐面。
(8)根据第(1)项所述的活组织检查装置，其中，所述远侧尖端消融组织。
(9)根据第(1)项所述的活组织检查装置，其中，所述振动部件使创伤部位止血。
(10)根据第(1)项所述的活组织检查装置，其中，所述外部插管、振动部件和内部套管中的至少一者是MRI兼容的。
(11)一种用于穿透和切除组织的活组织检查装置，包括：
具有侧面组织接收孔的空心插管；
用于将组织拉到所述侧面组织接收孔内的真空口；
具有从所述空心插管的远端延伸的远侧尖端的振动部件，所述远侧尖端用于穿透组织；以及
在所述侧面组织接收孔和所述振动部件之间的内部套管，所述内部套管防止组织穿过所述侧面进入口与所述振动部件接触。
(12)根据第(11)项所述的活组织检查装置，其中，所述内部套管是可滑动地设置在所述空心插管内的空心切割管，所述空心切割管可以从离开所述侧面组织接收孔的第一位置向阻挡所述侧面组织接收孔的第二位置移动，所述空心切割管的尺寸用于在其中接收所述振动部件。
(13)根据第(12)项所述的活组织检查装置，其中，所述振动部件上具有至少一个隔离部件，所述至少一个隔离部件用于将所述振动部件可滑动地与所述空心切割管和所述空心插管隔离开。
(14)根据第(13)项所述的活组织检查装置，其中，所述振动部件可滑动地设置在所述空心切割管和所述空心插管内，所述振动部件可以插入所述空心切割管和所述空心插管内以及从中取出。
(15)根据第(11)项所述的活组织检查装置，其中，所述活组织检查装置还包括可滑动地设置在所述空心插管内的空心切割管，所述空心切割管可以从离开所述侧面组织接收孔的第一位置向阻挡所述侧面组织接收孔的第二位置移动，其中所述内部套管和所述振动部件可滑动地设置在所述空心切割管内。
(16)根据第(11)项所述的活组织检查装置，其中，所述内部套管和所述振动部件彼此相对固定，并且可滑动且可移动地设置在所述空心切割管内，所述内部套管和所述振动部件可以从离开所述侧面组织接收孔的第一位置向所述内部套管阻挡所述侧面组织接收孔的第二位置移动，并且所述振动部件的所述远侧尖端从所述空心插管延伸。
(17)根据第(13)项所述的活组织检查装置，其中，所述振动部件上具有至少一个隔离部件，所述至少一个隔离部件用于将所述振动部件与所述空心套管隔离开。
(18)一种用于穿透和切除组织的活组织检查装置，包括：
空心探针，该空心探针具有在其中纵向延伸的第一通道以及延伸到所述第一通道中的侧面组织接收孔；
真空口，该真空口在操作中用于通过所述侧面组织接收孔将组织拉到所述第一通道中；
可滑动地设置在所述第一通道中的空心切割套管，所述空心切割套管用于切除通过所述侧面组织接收孔拉到所述通道中的组织；以及
在操作中置于所述空心探针的远端的能量输送组件，所述能量输送组件包括至少一个导电元件，该导电元件连接到用于穿刺组织的穿刺尖端。
(19)根据第(18)项所述的活组织检查装置，其中，所述穿刺尖端具有至少一个组织穿透表面，该表面从下面的组中选择：凹面、凸面、斜角面、弓形面、平面、球面、锥形面以及尖锐面。
(20)根据第(18)项所述的活组织检查装置，还包括隔离件，用于将所述压电尖端与所述空心探针隔离开。
(21)根据第(20)项所述的活组织检查装置，其中，所述隔离件至少是选自下面组中的一个：电隔离件或者振动隔离件，用于将所述穿刺尖端与所述空心探针隔离开。
(22)根据第(21)项所述的活组织检查装置，其中，所述能量输送组件包括至少一个压电元件，该压电元件在操作中连接到至少一个所述导电元件以振动所述穿刺尖端来穿刺组织。
(23)根据第(21)项所述的活组织检查装置，其中，所述能量输送组件在操作中通过至少一个所述导电元件连接到RF发生器，以便在操作中将所述穿刺尖端连接到所述RF发生器的第一电极。
(24)根据第(23)项所述的活组织检查装置，其中，所述至少一个所述导电元件中的第二个在操作中将所述空心探针连接到所述RF发生器的第二电极。
通过附图和说明书，本发明的这些和其它目标以及优点将变得明显。
附图说明
附图结合到说明书中并作为说明书的一部分，显示了本发明的实施方式，并且将与本发明上述的概述以及下面具体实施方式的详细描述一起来解释本发明的原理。
图1是磁共振成像(MRI)活组织检查系统的分解透视图，该系统包括手柄(“活组织检查装置”)具有根据本发明的直观的图形控制。
图2是图1中MRI活组织检查系统的定位夹具的侧面护板和底座的立体图。
图3是装在图2中右侧主靶导轨上的引导组件的立体图。
图4是图3中引导组件和图1中插管针和导入闭塞件的分解立体图。
图5是插入到图1和4中插管针内的导入闭塞件的立体图。
图6是图1中MRI活组织检查装置的尾部右侧立体图，其中一次性探针组件和键盘控制器从可重复使用的机架部分上分离。
图7是图1中MRI活组织检查装置的前部左侧立体图，其中一次性探针组件和键盘控制器从可重复使用的机架部分上分离。
图8是图7中可重复使用的机架部分的前部左侧分解立体图。
图9是图7中一次性探针组件的俯视图，其中除去了上盖以暴露输送腔中的内部构件。
图10是图7中一次性探针组件的前部左侧分解立体图。
图11是安装到图1中乳房线圈内的定位夹具和引导组件的后部左侧立体图。
图12是装入到图11中引导组件内的图7中MRI活组织检查装置的后部立体图。
图13是图7中MRI活组织检查装置的显示部分的顶部详解图。
图14是图12中MRI活组织检查装置、定位夹具和乳房线圈的后部右侧立体图，其中标记布置器械通过一次性探针组件的探针插入。
图15是图1中活组织检查系统的分解透视图，该活组织检查系统包括超声波组织穿透系统。
图16是图12中MRI活组织检查装置的后部立体图，其中超声波穿透系统置入到图11中引导组件内并穿透组织。
图17是图15中超声波组织穿透系统组件的侧视图，显示了包括插管针的超声波手柄组件的截面。
图18是图17中超声波手柄组件的轴和插管针的横截面。
图19是图17中超声波手柄组件的侧面立体图，显示了暴露的轴元件。
图20是图17中具有插管针的超声波手柄组件的超声波作用远侧尖端的横截面图，插管针穿入乳房组织和硬肿瘤中。
图21是图20中的替换横截面图，其中超声波远侧尖端从插管针上取下，插入了图1中的MRI活组织检查装置，并且硬肿瘤的一部分被拉到MRI活组织检查装置的探针内。
图22是图21中的替换横截面图，其中插入了图1中的MRI活组织检查装置，并且MRI活组织检查装置的刀管部分切割被拉到MRI活组织检查装置中的肿瘤。
图23是图22中的替换横截面图，其中插入了图1中的MRI活组织检查装置，并且MRI活组织检查装置的刀管全部切割被拉到MRI活组织检查装置中的肿瘤。
图24a-f是显示一些不同远侧尖端结构的系列立体图。
图25是显示准备与超声波穿透系统组合的手持式外科活组织检查系统的立体图。
图26是图25中手持式外科活组织检查系统的立体图，显示了准备插入手持式外科活组织检查系统的通常连续通道内的超声波穿透系统的第一变例。
图27是图25中手持式外科活组织检查系统的立体图，显示了准备插入手持式外科活组织检查系统的通常连续通道内的超声波穿透系统的第二变例。
图28是图26中手持式外科活组织检查系统的端部执行器和超声波穿透系统在穿入乳房组织时的横截面图。
图29是图26中手持式外科活组织检查系统的端部执行器的横截面图，其中除去了超声波穿透系统，并且一部分硬肿瘤被拉到边孔内并被切除。
图30是外科活组织检查系统的替代端部执行器的横截面图，其中超声波穿透和烧灼系统连接到外科活组织检查系统的远端。
图31是外科活组织检查系统的替代端部执行器的横截面图，其中双极RF穿透和烧灼系统连接到外科活组织检查系统的远端。
具体实施方式
一种活组织检查装置优选包括能量输送系统如超声波组织穿透系统，以减小组织穿透力，改进硬肿瘤的穿透和切除，并改善止血。另外，超声波组织穿透系统通过消除从活组织检查装置的穿透端增加的外科针刀的长度，来改进侧面活组织检查口的访问，并且移动侧面活组织检查口更加靠近穿透端来提供增强的组织访问。基于能量的穿透系统还能够切除难以抵达的组织，并提供改善的止血，能够解决出血问题。侧面活组织检查口能够被阻挡以防止组织与能量输送系统的动作元件接触而受到损伤。能量输送系统能够适用于各种活组织检查系统，包括MRI活组织检查装置和手持式活组织检查装置。
MRI活组织检查装置
转到附图，其中在几副图中相同的附图标记表示相同的部件。在图1-3中，磁共振成像(MRI)兼容式活组织检查系统10具有控制模块12，该控制模块12通常置于具有MRI机器(未显示)的屏蔽室的外面，或者至少间隔开以便减轻其强磁场和/或灵敏的射频(RF)信号检测天线的有害干扰。如美国专利No.6,752,768中所述，在控制模块12中预先编程一些功能来帮助获取这些组织样品，该专利通过引用并入本文。控制模块12控制MRI活组织检查装置(“手柄”)14并为该装置提供能量，该装置14通过定位夹具16定位和引导，定位夹具16连接到乳房线圈18，该乳房线圈18置于MRI机器的台架(未显示)上。
线缆管理线轴20置于从控制模块12的侧面伸出的线缆管理连接座22上。捆绑成护套线缆27的一对电气线缆24和机械线缆26缠绕在线缆管理线轴20上，分别用于控制信号的通讯和切割器的旋转/前进运动。具体而言，电气和机械线缆24、26各自的一端连接到控制模块12中的各自的电气和机械端口28、30，并且另一端连接到MRI活组织检查装置14的可重复使用的机架部分32。在不用时可以保持机架部分32的MRI对接杯34通过对接点安装托架36钩在控制模块12上。
安装到墙壁上的界面锁箱38将绳索40提供给控制模块12上的停机端口42。绳索40优选具有独特的终端，并且具有较短的长度，以防止控制模块12被意外放置太过靠近MRI机器。线上的封装44可以有利地将绳索40、电气线缆24和机械线缆26对准控制模块12上的它们各自的端口42、28、30。
真空助力由控制模块12与真空罐50之间连接的第一真空线路46提供，真空罐50捕获液体和固体杂质。管路套件52实现控制模块12与MRI活组织检查装置14之间的气动传递。具体而言，第二真空路线54连接到真空罐50的入口56。第二真空路线54分成两个真空路线58、60，它们连接到MRI活组织检查装置14。使用机架部分32中安装的MRI活组织检查装置14，控制模块12执行功能检查。生理盐水手动注入活组织检查装置14中，以用作润滑剂，并帮助实现真空密封。控制模块12启动MRI活组织检查装置14中的切割机构(未显示)，监视全部行程。机械线缆26或者活组织检查装置14中的联接参考电机的作用力和/或机械线缆26中的扭曲量与机械线缆26每端的转速或位置进行比较来监视，该作用力用于驱动机械线缆26旋转。
紧挨着可重复使用的机架部分32上的显示区域61，可以从可重复使用的机架部分32上拆卸的远程键盘62通过电气线缆24给控制模块12发送讯号，以增强MRI活组织检查装置14的临床控制，尤其是在远处(例如30英尺之外)将控制模块12不方便地插入定位夹具16和/或放置之后，不方便在MRI活组织检查装置14本身上进行控制时。在插入之后，可以访问可重复使用的机架部分32上的尾端指轮63来旋转组织样品将被获取的一侧。
定位框架68上的左右平行的上部导轨64、66分别侧向可调节地容纳在左右平行的上部轨道70、72内，该上部轨道70、72接合到乳房线圈18的患者支撑平台78的下侧74，且位于患者支撑平台78中所形成的选择的乳房开口76的每一侧。乳房线圈18的基部80通过中心柱82连接，该中心柱82在乳房开口76之间接合到患者支撑平台78。并且，一对外侧垂直支撑柱84、86位于各个乳房开口76周围间隔开的每一侧，限定了放置定位夹具16的侧向凹槽88。
在图1-2中，选择的乳房沿内(中间)侧通过中间板90挤压，该中间板90向下容纳在定位框架68的中间三侧框架92内。通过侧面护板94将乳房从乳房的外(横)侧挤压，该侧面护板94向下容纳在定位框架68的侧面三侧框架96内，定义X-Y平面。X-轴相对于站立的患者垂直，且在面向定位夹具16的外露部分的医生观看时，对应左右轴线。
Z-轴垂直于X-Y平面，向乳房的中间侧延伸，通常对应MRI活组织检查装置14的一次性探针组件100的探针98的插入方向和深度，或者对应插管针(sleeve trocar)102的插入方向和深度，该插管针102具有插入的导入闭塞器(introducer obturator)104。为了清楚，词语“Z-轴”可以与“穿透轴线”互换使用，尽管后者可以是或者不是垂直于空间坐标，该坐标用于定位患者的插入点。这里描述的定位夹具16的型号允许穿透轴线以方便的或者临床上有利的角度非垂直于X-Y轴指向病变。空间坐标的原点可以反映由侧面护板(lateral fence)94在组织上施加的记号(dent)。作为替换，由基准保持器108保持的一次性基准指示器106中填充有MRI影像材料(例如KY润滑剂，生理盐水，钆)，并且使用盖子110密封。
探针98、插管针102和基准指示器106通过定位夹具16引导。具体参照图2，由侧面护板支撑的机架120在空间中定位左、右主靶向导轨121、122，每个导轨121、122则随之引导活组织检查装置14的基准指示器106、插管针102或探针98(图1)。每个主靶向导轨121、122包括接合轴124，该接合轴124容纳在高度(Y-轴)轭126的左侧或者右侧轴套125内，高度轭126基于机架主体128可垂直调节，且随之基于侧面护板94可侧向调节。作为替换，乳房线圈可以使机架主体能够安装在中间板90上，以便从中间访问。机架主体128包括近侧的矩形立柱132，厚壁134从该立柱132的远侧伸出，并在侧向上向外展开(形成左、右垂直矩形槽136、138)而作为托架140的一部分，所述托架140具有顶部和底部悬臂144、146，该悬臂144、146分别在侧面护板94中所形成的顶部轨道148上和近似于开放的下部轨道150上侧向滑动。在侧向调节杆151参照侧向测量导轨145向左或向右重新定位到所需位置时，可以抬升侧向(X-轴)调节杆151，使其远端149被抬高而与侧面护板94中所形成的底部轨道147脱离。
高度轭126是在远侧的中间部分断开以形成左、右锁柄(hand)152的矩形袖口(cuff)，所述左、右锁柄152分别在左、右垂直矩形槽136、138中垂直滑动。左、右锁柄152具有各自的山脊状近侧表面(未显示)，该表面可以被选择地向近侧拉动以便由高度锁杆156锁止接合，该高度锁杆156在每个垂直矩形槽136、138的近侧上具有山脊状表面158。在高度轭126重新垂直定位时，高度锁杆156上升，使高度轭126松开与机架主体128的锁止接合。对于高度调节，高度轭126的近侧顶面作为瞄准器160，以读取高度锁杆156近侧表面上所具有的高度测量刻度162。
接合轴124可以旋转，从而穿透轴线可以包括向上或者向下轨迹。在所示的结构中，高度轭126的近侧拐角包括可以由角度锁杆166选择的角度锁扣164(例如，-15°，0°，+15°)。主靶向导轨122包括远侧锁扣167，作为基准保持件108(图1)的原始参考。
在图3-4中，导向组件200可以接合到图2中由侧面护板支撑的机架120，该组件200包括框架(cradle)202，该框架202的上部侧面202a向上展开以接合主靶向导轨122的底部凹槽203。下部侧面202b水平展开以提供机架导轨204，该机架导轨204位于穿透轴线的下面。为了为MRI活组织检查装置14(图1)提供附加引导，副靶向导轨206包括侧面凹槽208，该侧面凹槽208沿主靶向导轨122的纵向引导片210导向。当完全接合在纵向引导片210上时，棘爪212在棘爪弹簧214的作用下围绕侧面窗口218中的垂直爪销216枢转，侧面窗口218位于副靶向导轨206中的近侧，棘爪212落入近侧锁扣220中，该近侧锁扣220位于主靶向导轨122的近侧。棘爪弹簧214可以将棘爪212保持在中立位置，该中立位置用于副靶向导轨206的装配和后续的拆卸，或者包括一对相对的棘爪弹簧(未显示)用于此目的。
在图4-5中，插管针102包括空心轴(或插管)223，该空心轴223在近侧连接到圆柱形轮毂224，并具有靠近开放的远端228的侧面开口226。圆柱形轮毂224具有向外露出的指轮230，用于旋转侧面开口226。圆柱形轮毂224具有内部凹槽232，该凹槽232包围鸭嘴形密封件(duckbill seal)234、刮片式密封件(wiper seal)23 6和密封圈(seal retainer)238，以便在轴223为空时提供流体密封，并用于密封锁插入的导入闭塞件104。
导入闭塞件104优选包括具有对应特征的一些构件。空心轴242包括在成像侧切口246与近侧端口248之间连通的流体腔244。空心轴242纵向延伸，在插管针102的远端228之外接合有穿刺尖头249。闭塞件手柄250包围近侧端口248，且包括锁止特征252，该锁止特征252包括可视的角度指示器254，该角度指示器254可旋转地接合指轮230，使成像侧切口246与插管针102中的侧面开口226对准。闭塞件密封帽256可以在近侧接合到闭塞件手柄250内，以封闭流体腔244。闭塞件密封帽256包括锁止件或者锁止特征258，该锁止件或者锁止特征258包括可视的角度指示器259，该角度指示器259对应闭塞件指轮帽230上的可视的角度指示器254。闭塞件密封帽256可以由刚性的、柔软的或者弹性的材料成型。
回到图3和图4，插管针102在穿透组织期间通过套管支座260引导，该套管支座260具有插管轮毂262用于接收插管针102的圆柱形轮毂224。套管支座260具有侧面插管轮毂凹槽264，该凹槽264沿副靶向导轨206的顶部和底部导向凸缘266、268滑动，每个凸缘266、268具有对齐的、凹脊状的棘齿表面270，该表面270与顶部和底部导轨锁止摇杆锁闩276、278各自上的顶部和底部棘齿特征272、274相互作用，所述锁闩276、278通过套管支座260每侧的各自的顶部和底部锁销280、282接合。棘齿特征272、274的向近侧倾斜，以允许向远侧运动。每个导轨锁止摇杆锁闩276、278的远侧部分通过各自的导轨锁止压缩弹簧284、286从套管支座260向外偏压，以便将棘齿特征272、274偏压到与引导凸缘266、268的棘齿表面270相接触。导轨锁止摇杆锁闩276、278的同时受压允许插管支架260被向近侧拉动，拉出在其中支撑的插管针102，直到插管支架260抵达副靶向导轨206的近端，基于此，插管支架260驱动棘爪212顺时针旋转(从顶部看)，并因此与副靶向导轨206接合，副靶向导轨206从主靶向导轨122上解锁，使得通过继续向近侧运动而可以从主靶向导轨122上卸下。
在首先将副靶向导轨206装到主靶向导轨122上之前，优选将套管支座260可调节地置于副靶向导轨206上来设置所需的穿透深度。具体而言，通过月牙形的深度指示器292形成深度导向290，所述深度指示器292具有侧向凹槽296用于接合顶部和底部引导凸缘266、268。位于侧向凹槽296顶部和底部的向前倾斜的表面298用于接合副靶向导轨206上的山脊状棘齿表面270，允许通过从副靶向导轨206的远端插入深度指示器292来进行装配。然后，摩擦接合将抵抗向近侧进一步运动，并且强力反抗任何向远侧的运动，尤其是从深度导向290的深度丝杠(depth lead screw)300上向远侧的运动，当使用深度驱动杆305来旋转深度丝杠300并将深度丝杠300纵向定位在其中时，该丝杠300的远端302在深度指示器292中的通孔304内旋转，并且其近端向侧面偏斜。深度丝杠300的中部容纳在纵向通孔306内，该纵向通孔306形成于插管支架260内且位于其侧面凹槽208的外侧。对于粗略的深度调节，深度丝杠300上的外导向螺纹307选择性地接合插管支架260，直到顶部和底部粗略调节按钮308、310向内陷入到插管支架260内，该粗略调节按钮308、310包括各自的顶部和底部粗略调节压缩弹簧312、314。每个粗略调节按钮308、310包括各自的垂直伸长的孔316、318，该孔316、318的内表面具有蜗轮段320、322，该蜗轮段320、322在受到松弛的粗略调节压缩弹簧312、314的压迫时将接合深度丝杠300上的外导向螺纹307。
回到图3，指轮230使用插管针102的其它部分(被省略)接合到插管支架260的插管环(sleeve hug)262上。与本发明一致的申请可以包括MRI活组织检查装置的探针，该探针可以是包括穿刺尖头的探针，可以是不穿过空心轴(插管)223而以其它方式使用的探针。由此，具有类似密封部件的指轮可以装入到插管支架260中。
在图6-7中，MRI活组织检查装置14具有一次性探针组件100，如图所示，该探针组件100与可重复使用的机架部分32分离，并且远程键盘62从可重复使用的机架部分32上释放。护套线缆27连接到可重复使用的机架部分32的下侧且位于尾端指轮63的远侧，以改进可重复使用的机架部分的平衡和支撑，该机架部分则随之可以通过工字梁形状的机架导轨324接合到机架引导轨道204(图4)中，机架导轨324的上表面326接合在机架基板330的底部凹槽328内。机架基板330上的山脊状部件331在接合过程中引导一次性探针组件100。机架导轨324的变窄的上部远侧表面332还接合向下抓持凸缘334，该凸缘334紧挨着一次性探针组件100的远侧指轮336向下延伸。下悬式壳体337被紧固到机架基板330的近侧底面部分。
一次性探针组件100还具有向后滑动而与可重复使用的机架部分32接合的底面。具体而言，变窄的近端338形成于上盖340中，远侧锁臂342与上盖340的每一侧分离，但是朝近侧方向具有解锁按钮344位于上盖340的外表面346上，该解锁按钮344向下压缩以便使锁面348(图6)从机架基板330的可重复使用的机架部分32中的向远侧开放的接收孔352的远侧舌片350上分离。
可重复使用的机架部分32的近侧上盖356的上部近侧表面中的凹板354设计成用来接收远程键盘62。近侧上盖356还定义了接收孔352的上部。凹板354具有前导孔360和后锁孔362，分别用于接收远程键盘62尾端的前齿363和可挠曲的解锁片364，以便选择性地将键盘62接合到可重复使用的机架部分32以及从该机架部分32分离。键盘62还包括平移摇杆按钮366，该按钮366具有远侧前进、默认中立以及向后缩回控制位置。可以通过尾端按钮368编程一些模式功能如生理盐水冲洗。
具体参照图6，一次性探针组件100具有位于尾部对接端370上的多个互连元件。向右偏置的真空软管接头372用于接收真空管(未显示)，该真空管由在其下面和尾部延伸的摩擦夹373夹持以防止意外松开。右侧狭槽374向远侧开放，且形成于机架基板330和近侧顶盖356之间，以便在一次性探针组件100接合到可重复使用的机架部分32时用于接收这种真空管。中心的花键驱动轴375接合尾端指轮63，并与远侧指轮336联系，以便将探针98中的边孔376旋转到所需一侧，在此过程中通过远侧指轮336上的箭头指示器378从视觉上进行确认。右侧的花键驱动轴380实现刀具平移，左侧的花键驱动轴382实现刀具旋转。
远侧指轮336和探针98装在圆柱形轮毂384上，该轮毂384是下部壳体358伸出与上盖340匹配之外的远侧部分。样品通孔386穿过圆柱形轮毂384，用于接收进入探针98的刀管(cutter tube)388(图9)的旋转和平移，并且用于接收通过缩回刀管388而取得的组织样品(未显示)。当刀管388全部缩回到在上盖340和下部壳体358的近侧部分之间所形成的输送腔380中时，从被刀管388包围的真空管394向远侧延伸的尖端392将缩回的组织样品装到样品获取平台396上，该平台396为上盖340和圆柱形轮毂384之间的交换区域(relieved area)。
在图8中，应当认识到，护套线缆27连接到机架基板330上，且将单一的机械驱动旋转传递给装到机架基板330上的定速比变速器398，并且与解码器400电通信，该解码器400接合到接收孔352尾部的定速比变速器398。护套线缆27还通过线束(未显示)与显示区61电通信，并且通过线缆组件404与键盘62电通信，线缆组件404包括夹持键盘线缆404的应力缓解托架404并且紧固到护套线缆27的近侧。定速比变速器398具有贯通开口408用于接收中心花键驱动轴375(图6)的远端，以便转动地接合在近侧接收的锥形轴410，该锥形轴410形成于尾端指轮63的远侧并且通过0形环412密封。形成于定速比变速器398远侧的右侧开口414可旋转地接合一次性探针组件100的右侧花键驱动轴380，用于使刀管388前进以及缩回(“平移”)。形成于定速比变速器398远侧的左侧开口416可旋转地接合一次性探针组件100的左侧花键驱动轴382，用于在刀管388的远侧刀刃经过探针98的边孔376滑动时旋转刀管388。
在图9-10中，一次性探针组件100的输送腔390包括具有螺纹轴孔420的刀具输送架418，该螺纹轴孔420套在细长的平移轴422上，该平移轴422的近端是右侧花键驱动轴380，该右侧花键驱动轴380由下部壳体358尾壁425中的尾部右侧圆柱形轴承424支撑。在圆柱形轴承424外圆周上的沟槽中容纳有O形环426。螺纹平移轴422的远端428在接合到下部壳体358前壁432上的远侧右侧圆柱形轴承430中转动。在圆柱形轴承430外圆周上的沟槽中容纳有O形环434。细长平移轴422的螺纹中部436位于非螺纹远侧延伸部分438和非螺纹近侧延伸部分440之间，这两个部分允许刀具输送架418的螺纹轴孔420从螺纹中部436分离。
远侧压缩弹簧442和近侧压缩弹簧444分别位于非螺纹远侧和近侧延伸部分438、440上，用于在细长平移轴422反转时，压迫刀具输送架418的螺纹轴孔420向后与螺纹中部436接合。具体而言，刀具输送架418包括与上盖340(未显示)的底面滑动接合的顶部轴向凹槽446，以及与下部壳体358的顶面上的纵向轨道450接合的底部纵向导向448。在如此抑制旋转时，细长平移轴422的旋转将使刀具输送架418作相应的纵向平移，刀具输送架418的远侧和尾侧成对的夹持凸缘452、454在侧向上被保持在左侧，以便分别与刀具正齿轮452的齿部460的每一侧上所形成的远侧和近侧沟槽456、458相接合，刀具正齿轮462具有轴孔用于施加真空。
在这一端，真空软管接头372连接到安装结构464上，该安装结构464被夹持在上盖340和下部壳体358之间以便在输送腔390内形成节流孔(orifice)466，该节流孔466与刀具齿轮462的轴孔对齐且与真空软管接头372流体连通。
具体参照图10，真空管394的近端容纳在节流孔466内。矩形导向467支撑着真空管394向远侧延伸的尖端392，并且接合在上盖340和下部壳体358之间。刀具管388套在真空管394上并使真空管394平移。连接到刀具齿轮462近端的密封帽468动态密封真空管394的外圆周，从而向近侧供应给向远侧延伸的尖端392的真空压力不会在输送腔390中释放。刀管388前进到真空管394的开放远端周围，经过样品获取平台396以密封到后部密封件470上，该后部密封件470基本上将近侧开口472密封到插管接头474中，该插管接头474在圆柱形轮毂484中旋转。插管接头474具有远端476，该远端476可旋转地接合远侧指轮336。远侧和近侧O形环478、480分别位于远侧和近侧沟槽482、484内，该沟槽482、484跨过插管接头474的侧向通道486，以提供一定程度的摩擦阻力来避免意外旋转，并且有效密封侧向通道486用于真空助力，使组织脱垂并获取样品。在远侧指轮336远侧表面的中心开设非圆形开口488。探针98的探针管490的近端穿过非圆形开口488延伸以便接收刀管388的远端。在其长度上连接到探针管490的侧面管492与接头插管474的侧向通道486连通。侧面管492具有横腔，该横腔通过腔孔494(图9)与边孔376下面的探针管490/刀管388所形成的刀具腔连通。
通过尾端指轮63旋转的中心花键驱动轴375驱动轴496旋转，该轴496的键合远端498接合到小齿轮500并随之驱动小齿轮500旋转，该小齿轮500齿轮啮合到近侧正齿轮502，该近侧正齿轮502形成插管接头474的外部近侧圆周。键合的远端498的圆柱形远侧尖端504在下部壳体358中的轴孔(未显示)内旋转。尾端指轮63的旋转因此驱动探针98旋转。
远侧肘状气动配件506支撑在下部壳体358内，上端508与插管接头474的侧向通道486连通，尾端510连接到由下部壳体358支撑的通风气动管路512。通风气动管路512的另一端连接到近侧肘状气动配件516的远端514，该配件516的横端518向外界大气开放。从横端518通过腔孔494传递大气压力的各种构件设计成使得可以通过探针管490取出组织样品。在切割组织样品之前通过真空软管接头382气动抽吸空气，将在边孔376处实现足够低的压力以便使组织脱垂以便切割。
细长旋转轴520在近侧终止于左侧花键驱动轴382，该驱动轴382由左侧尾侧圆柱形轴承522可旋转地支撑，该轴承522的外圆周上具有沟槽以容纳O形环524，并且容纳在下部壳体358的尾壁425内。细长旋转轴520的远端526可旋转地容纳在左侧远侧圆柱形轴承528内，该轴承528的外圆周上具有沟槽以容纳O形环530，并且容纳在下部壳体358的前壁425内。当刀具输送架418前进以便使刀管388滑动经过边孔376时，刀具正齿轮460啮合细长旋转轴520的正齿轮部分532。刀管388的成比例旋转将保证有效切割组织。在不切割时停止旋转将有利地提高组织样品的获取。
在使用时，在图11中，定位夹具16已经装入到乳房线圈18中。引导组件200已经预设了所需的插入点、所需的穿透轴线和穿透深度。在插管针102/导入闭塞件104已经插入并且经过影像确认之后，除去导入闭塞件104并插入活组织检查装置14的探针98，如图12所示。插管针102的形状调准探针98，这通过使用插管针102的指轮230上的可视角度指示器对准远侧指轮336上的箭头指示器378进行视觉辅助。医生可以通过按压键盘62上的平移摇杆按钮366和尾部按钮368来实现活组织检查装置14的操作，同时参考显示区61上关于活组织检查装置14的状态信息。在图13中，显示区61优选包括刀具位置柱状图534，该柱状图534具有远侧和近侧指示器536、538，可以与已经有多少个光段540通过发光来指示刀管388相对于边孔376的进度进行比较。可以拨动尾部按钮368使活组织检查装置14通过三个模式进行循环，这通过位置LED指示器542、样品LED指示器544和清零LED指示器546进行指示，这些指示器具有对应的标记来图形化显示活组织检查装置在该模式中的操作。具体而言，位置模式描述器(depiction)548表示刀管388可以前进和后退，例如在将探针98插入插管针102之前关闭边孔376。在样品模式描述器550中，实现真空助力，通过刀管388抽吸足够的空气将组织脱垂到在刀管388平移的同时保持开放的边孔376中。在清零模式描述器552中，在完全缩回刀管388以取出组织样品的同时保持真空。在图14中，在通过圆柱形轮毂388中的样品通孔386时使用标记装置548。
基于能量进行组织穿透的活组织检查装置
在图15中，显示了一种具有基于能量的组织穿透系统的外科手术活组织检查系统610。基于能量的系统能够减小穿透硬肿瘤所需的力，改善止血，并且能够有利地移动靠近插管针102远端的外部插管或者插管针102的组织接收侧面孔226。另外，基于能量的系统能够用来消融和烧灼通过侧面孔226所无法访问的组织。如图所示，能够提供一种基于能量的系统，例如但不限于超声波穿透系统615，该系统615包括能够由开关621致动的发生器620，以及在操作时通过电缆622连接到发生器620的手柄组件625。插管针102可以是手柄组件625的固定连接元件，或者如果需要，也可以可拆卸地与之连接。图16显示了插入到外科手术系统610中以穿透组织的超声波穿透系统615。
现在参考图17，发生器620通过电缆622以选择的振幅、频率和相位向手柄组件625发送电信号。手柄组件625包括声学组件630，其具有能够响应电信号的一个或者多个压电元件631。压电元件631响应电信号进行膨胀和收缩，从而将电能量转化为机械运动。机械运动在驻波中产生经过声学组件630传播的超声波能量的纵波，以选择的频率、振幅和相位来振动声学组件630，所述频率、振幅和相位中的任意一者都可以是时间或其它变量的函数。刀片或振动组件635可拆卸地连接到声学组件630上。手柄组件625包括延伸到可拆卸的振动组件635的声学组件630的近侧部分，振动组件635从该近侧部分向远侧延伸。手柄626包围声学组件630的近侧部分，并防止医生接触振动元件。套管640能够使用盖子642可拆卸地连接到手柄626，并包围振动部件635但露出远侧尖端650。隔离件641可振动地将振动部件635与固定套管640隔离开。
声学组件630的零件能够以相同的共振频率进行振荡或者共振。对其中包含的元件进行调谐来放大远侧尖端650的运动，并且能够产生简谐振动与声学系统中的其它部分共振，这将导致远侧尖端650最大幅度的前后运动。声学组件630的远侧尖端650能够放置成与患者的组织相接触，以便将超声波能量输送给组织。
当远侧尖端650与组织振动接合时，能够出现组织的空化、细胞破壁和乳化。组织中的内部细胞摩擦能够产生热能量或热量，使振动尖端650的侧面产生烧灼并提高止血。产生的热量足以断开蛋白氢键，导致高结构蛋白(即胶原蛋白和肌肉蛋白)变质(即组织变成不良)。切割的量以及得到的凝血程度能够根据远侧尖端650的振幅、使用者施加的压力大小以及远侧尖端650的锋利性而变化。声学组件630的远侧尖端650可以将振动能量集中到与远侧尖端650直接接触的组织上，并且能够强化和局部定位(localize)热能和机械能的传递。显示的插管针102可拆卸地连接到手柄组件623上。图18是沿线A-A获取的横截面，显示了振动部件635、套管640和空心轴或插管223的组装。套管640能够阻挡插管223中的孔226，以防止组织与振动部件625接触。
这仅仅是超声波系统615的操作的概述，本领域技术人员将会知道具体构件如何工作来实现该基于能量的外科操作。还将理解的是，图15和16中举出的超声波装置以及上述的元件仅仅是代表性的，如B.Estabrook等人的名称为“Methods and Devices for Controlling theVibration of Ultrasonic Components”的美国专利No.6,274,963中所公开的那些装置和元件，该专利通过引用并入本文。
图19显示了手柄组件623和插管针102的元件的分解图。振动部件635可拆卸地连接到手柄625中的超声波组件630，套管640在振动部件635上滑动以便使用环箍642可拆卸地连接到手柄625。手柄组件623可滑动且可拆卸地安装在插管针102中。
图20-23显示了超声波穿透系统615如何在活组织检查外科中展现优点。现在参考图20，显示的是超声波穿透系统615的手柄623的远端650穿过乳房680且穿过硬肿瘤685的横截面图。显示的肋骨686靠近肿瘤685，而不是将硬肿瘤685推向一侧，振动尖端650已经穿过硬肿瘤685和靠近肋骨686的组织。
在图21中，手柄组件623已经从插管针102中撤出。插管针102仍然停留在乳房中，MRI活组织检查装置手柄14(图1)的探针98已经置于空心轴或者插管223中。使用远侧尖端650在乳房680和肿瘤685中所开设的通道使得插管针102的空心轴或者插管223能够被推到靠近肋骨686。插管针102靠近肋骨的运动使医生可以访问靠近肋骨686的肿瘤685的一部分。当MRI活组织检查装置手柄14的探针98位于侧面孔226下，使用真空将组织从硬肿瘤685拉到插管针102的侧面孔226中，并且拉到探针98的边孔376内。
在图22中，旋转和平移的刀管388在探针98的侧面管492中向远侧平移，并且已经部分切割了硬肿瘤685。在图23中，硬肿瘤685的第一部分687在旋转和平移的刀管388中被完全切除。
图24显示了用于振动部件635的远侧尖端650的一些替换的尖端实施例。每个远侧尖端650具有至少一个作用面651用于穿透、切割或者凝固组织。本发明的至少一个作用面651可以是圆锥形、斜角形、球形、凹形、凸形、弓形、半球形、尖锐形的表面或者它们的任意组合。图24a具有圆锥形表面652，图24b具有至少一个斜角表面653。图24c显示与至少一个斜角表面653组合的球面654，图24d显示具有至少一个弓形表面655和至少一个凹面67和凸面658的远侧尖端650。图24e显示具有半球形表面656和至少一个斜角表面653的远侧尖端650。图24f显示具有至少一个斜角表面653和至少一个凹面657的远侧尖端650。另外，上述任意的表面都可以是切割刀刃659。虽然上述远侧尖端650能够与本发明的装置一起使用，但是上述列举的表面不是为了以任何方式来限制能够在本发明的范围内起作用的远侧尖端650的数量。
使用能量组织穿透的手持式活组织检查系统
虽然本发明的上述实施方式组合了图1中所示的外科系统10的元件和超声波穿透系统615，但能够通过组合超声波穿透系统615和手持式活组织检查装置能够实现本发明的替换实施方式。图25-28显示了能够与超声波穿透系统615进行组合的完整的手持式活组织检查系统710。手持式活组织检查系统710包括手柄组件730，该手柄组件730包括手柄732和可拆卸连接的机架734。在图25中，手柄组件732具有远侧活组织检查探针788，该探针788具有从中延伸的边孔764。机架734能够包括开关和控制器。控制绳766和旋转轴768将连接的机架734可拆卸地连接到控制模块746和活组织检查探针788。控制模块746为近侧探针组件732提供旋转运动为手柄组件730提供能量，以及生理盐水748、压缩空气750、电源772和真空源736的微处理器控制。第一侧面管738从探针组件732向控制模块746延伸，以便将真空源736、生理盐水源756和压缩空气源750连接到手柄组件730。
通常连续的通道724从探针组件732中的近侧开口726经过手柄组件730向活组织检查探针788的远端延伸。活组织检查探针788上的边孔764与该连续的通道724连接。通道724清楚显示于图26中，其在后面作更详细地描述。通道724的近侧开口726用于接收超声波气动系统615或者第二轴向管740，该第二轴向管740使用真空将组织样品输送给组织储存组件562，该组件562连接到控制模块746和真空源736。
图26和27显示了活组织检查手柄组件732的横截面图和可拆卸的机架734的概要视图。管状刀具755可旋转且可滑动地设置在探针788的金属插管790的上部刀具腔792内以及手柄组件732内。提供正齿轮用于旋转刀具755，螺旋齿轮用于向近侧和远侧移动刀具755。超声波穿透系统615的手柄组件626置于可拆卸的机架734下面(未显示)。通常连续的通道725由后腔756、空心刀具755的钻孔以及上部刀具腔792形成。真空口或者下部真空腔794通过开口连接到上部刀具腔792，以便将组织拉到边孔764中。
在图26中，显示了超声波穿透系统615的第一变例以备插入连续通道725内，外部插管640由盖子642保持。超声波穿透系统615的第一变例的插入使用外部插管640阻挡边孔764，并且通过远侧钻孔727露出远侧尖端650。
图27显示了超声波穿透系统615的第二变例以备插入手柄组件730中，其中除去了外部插管640和盖子642，并露出了振荡部件635。插入活组织检查手柄组件730内的第二变例，使得振荡部件的侧面通过边孔764露出。对于这个变例，通过边孔764接触的组织通过将探针组件732的刀具755向远侧移动来阻挡。振动部件640上的隔离件641防止振动部件接触刀具755的内壁，该内壁形成连续通道725的一部分。当超声波穿透系统615全部插入到活组织检查手柄730内时，远侧尖端650穿过活组织检查探针788的远侧钻孔727(图26)延伸。在致动时，手持式外科系统的远侧尖端650穿透组织。
图28显示了在穿透乳房组织680时的超声波穿透系统615的第二变例。赋能的远侧尖端650穿过活组织检查探针788远端的开放的远侧钻孔727延伸。所示的远侧尖端650穿过乳房680和肿瘤685，在其中形成通道。外部管状刀具755阻挡活组织检查探针788的边孔764并防止不需要的组织与振动部件635接触。振动部件635具有与之连接的隔离件641，用于振动地隔离所述部件635防止与管状刀具755和后腔756的内壁接触。
在图29中，赋能的远侧尖端650已经穿到乳房组织680中，将边孔376定位到肿瘤685中，医生准备关断超声波能量，将超声波穿透系统615从通常连续的通道725中以及探针组件532中拉出。移动管状刀具755阻挡边孔764，防止组织接触振动部件635。如图30所示，一旦通常连续的通道725通过除去振动部件635而被打开时，第二轴向管540就能够连接到通常连续的通道725(图15)。现在，能够施加真空将组织吸到边孔764中，并且将管状刀具755向远侧移动来切除肿瘤685。在施加真空时，硬肿瘤685被吸到边孔564中，并且乳房组织680被吸到活组织检查探针788远端的开放的远侧钻孔726内。开放的远侧钻孔726设计成允许振动部件635的远侧尖端650通过，但最小化开放的远侧钻孔726的尺寸，以便在施加真空时它能够容易地由乳房组织680来密封。一旦切除，组织样品687能够从通常连续的通道725中拉出，沿第二轴向管740向下，然后进入到组织储存组件562中。
图30公开了连接到组织活组织检查系统远端的基于能量的组织穿透系统的替换实施方式。在图29中，声学组件810具有一个或者多个近侧压电元件811连接到远侧刀片812，该声学组件810连接到活组织检查探针815的远端。压电元件811响应电信号进行膨胀和收缩，从而将电能量转换为机械运动来振动远侧刀片812。机械运动在声学驻波中产生通过声学组件810传播的振动能量中的纵波，以以选择的频率和振幅来振动声学组件810和远侧刀片812。远侧隔离件813将声学组件810装在活组织检查探针815的远端，并且远侧紧固件814将预载荷施加到声学组件810的元件上。一对第一和第二电线820、821能够沿活组织检查探针815纵向延伸，以将压电元件811电连接到发生器620。
图31公开了连接到组织活组织检查系统远端的基于能量的组织穿透系统的分解的替换实施方式。对于该实施方式，RF发生器930将RF双极能量输送给RF探针组件910。第一电极丝920在操作中连接到位于RF探针组件910远侧尖端的第一电极912。第一电极丝920还在操作中连接到发生器930的第一电极。第二电极丝921在操作中连接到第二电极921，该第二电极921连接到RF发生器930的第二电极。第一电极丝912和第二电极921安装在绝缘件913上，该绝缘件913由但不限于例如陶瓷制造。绝缘件913安装在探针组件910的轴922上。使用合适的切割波形赋能的发生器930使探针组件910能够变成RF双极穿透装置。作为替换，在发生器930中切换到凝血波形使探针组件910能够变成RF双极烧灼装置。如果需要，能够使用混合的波形或者任意形状的波形。
至少一个传感器能够增设在组织探针附近，在使用能量输送系统穿透组织时用来检测组织性质。组织性质的检测结果可以反馈给发生器控制器来改变能量输送。例如，可以将温度传感器设置在RF探针910处，在探针910穿入组织中时提供实时信息以改变能量输送。另外，作为例子，可以使用温度传感器来监视利用超声波组织穿透系统所得到的组织效果。
应当认识到，任何专利、公开出版物或者其它公开材料全部或者部分地说过通过引用并入本文，所引用的程度仅仅是该引用的材料不与本发明中目前所公开的限定、声明或者其它公开材料相抵触。由此且在所需的程度上，这里清楚陈述的公开内容将取代任何通过参考在此引述的相抵触的材料。任何材料或者其部分说过通过参考在此引述的，但与在这里所公开的限定、声明或者其它公开内容相抵触的，将仅仅在引用的内容与本发明公开的内容之间不存在冲突时才加以引用。
已经显示和描述了本发明的各种实施方式，这里描述的方法和系统的进一步改编可以通过本领域技术人员在不背离本发明范围的前提下作出适当修改来实现。已经提及了一些潜在的修改，其它一些修改将对于本领域技术人员来说是显而易见的。例如，上述的实施例、实施方式、几何形状、材料、尺寸、比率、步骤等等都是描述性的而不是必需的。因此，本发明的范围应当依据所附的权利要求，并且理解为不限于说明书和附图中所示和所述的具体结构和操作。
虽然在这里已经显示和描述了本发明的一些优选实施方式，但是本领域技术人员很清楚这些实施方式仅仅是作为例子提供的。本领域技术人员在不背离本发明的前提下可以作出各种变例、改变和替换。因此，本发明仅仅通过所附的权利要求的精神和范围进行限定。

Claims (10)

1、一种用于穿透和移除组织的活组织检查装置，包括：
具有侧面组织接收孔的外部插管；
振动部件，其设置在所述外部插管内且具有在所述外部插管的远端露出的远侧尖端，所述远侧尖端用于穿透组织；以及
在所述振动部件和所述插管之间的内部套管，所述内部套管暴露所述振动部件的所述远侧尖端，并阻挡所述外部插管的所述侧面组织接收孔。
2、根据权利要求1所述的活组织检查装置，其中，所述振动部件以超声波频率进行振动。
3、根据权利要求1所述的活组织检查装置，其中，所述振动部件和所述内部套管具有至少一个在它们之间延伸的隔离元件，操作所述隔离元件能够将所述振动部件与所述内部套管隔离开。
4、根据权利要求1所述的活组织检查装置，其中，所述振动部件和所述内部套管可以插入所述外部插管内并且可以从所述外部插管内取出，所述振动部件和所述内部套管在插入和取出期间相对于彼此的位置保持不变。
5、根据权利要求1所述的活组织检查装置，其中，所述内部套管可拆卸地连接在所述振动部件周围。
6、根据权利要求1所述的活组织检查装置，其中，所述内部套管的至少一部分横截面为弓形。
7、根据权利要求1所述的活组织检查装置，其中，所述远侧尖端具有至少一个表面，所述至少一个表面从下面的组中选择：凹面、凸面、斜角面、弓形面、平面、球面、锥形面以及尖锐形面。
8、根据权利要求1所述的活组织检查装置，其中，所述远侧尖端能够消融组织。
9、根据权利要求1所述的活组织检查装置，其中，所述振动部件使创伤部位止血。
10、根据权利要求1所述的活组织检查装置，其中，所述外部插管、振动部件和内部套管中的至少一者是MRI兼容的。
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DE602007011003D1 (de) 2011-01-20
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US20080200835A1 (en) 2008-08-21

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