CN101664324B - 用于密封身体内腔的壁中的穿刺孔的设备 - Google Patents

用于密封身体内腔的壁中的穿刺孔的设备 Download PDF

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CN101664324B
CN101664324B CN2009101609162A CN200910160916A CN101664324B CN 101664324 B CN101664324 B CN 101664324B CN 2009101609162 A CN2009101609162 A CN 2009101609162A CN 200910160916 A CN200910160916 A CN 200910160916A CN 101664324 B CN101664324 B CN 101664324B
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R·S·金
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Kandele Health 529 Co ltd
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Abstract

本发明涉及用于密封脉管穿刺的装置和方法以及用于正确定位和布置密封设备的装置和方法。定位装置(11)包含管腔(27)，其从装置的远端区域开口(12)延伸而且靠近密封设备定位，其管腔延伸到设备近端区域的另一开口(13)。当远端开口连通血管中的血液时，血液流过管腔并从近端开口流出意味着对于用户的这一位置。当回撤密封设备使得进行这样布置该密封设备以便它阻断血液流入远端时，用户将知道密封设备的位置。接着将密封设备与传送设备分离。

Description

用于密封身体内腔的壁中的穿刺孔的设备
本申请是国际申请日为2005年5月20日、名称为“定位器和传送设备及其使用方法”、国家申请号为2005800162749(国际申请号为PCT/US2005/017846)的专利申请的分案申请。 
发明领域
本发明通常涉及用于密封或关闭穿过组织通道的装置和方法，尤其是涉及用于密封与身体管腔，诸如血管所沟通的穿刺或其他开口，以及涉及传送该设备的装置和方法。 
发明背景 
通常通过经患者皮肤和肌肉组织将一中空的针插入到脉管系统中来执行导管插入术和介入操作，诸如血管成形术或支架术。接着可将导线穿过针的管腔进入已经被该针所刺入的患者血管中。可去除该针，并且可将插管器护套沿着导线进入到血管中例如结合后继的扩张器。接着导管或别的设备可穿过插管器护套的管腔并沿着导线进入到一个位置用以执行医疗操作。这样，插管器护套可方便将各种设备插入到血管中，而将对血管壁的损伤减到最小和/或在操作期间将出血降到最小。 
一旦操作结束，可去除设备和插管器，在血管壁上留下穿刺点。可对该穿刺点施加外部压力直到发生凝固和伤口愈合。然而，这一操作可能是费时且昂贵的，需要医生或护士差不多一小时的时间。对患者也是不舒服的，并且需要患者在手术室、导管室或保持区域内保持固定不动。另外，在止血发生前从出血中存在血肿的危险。 
已经提出了多种装置用于通过堵塞穿刺点来经皮密封脉管穿刺。例如，授予Kensey等人的美国专利号为5,192,302和5,222,974描述了可通过插管器进入到穿刺点的生物降解塞的使用。当布置好后，该塞可密封血管并提供止血。然而，这种设备很难关于血管恰当地定位，这一点特别重要因为通常不希望将塞子的材料，例如胶原质暴露在血流中，这种情况下其可顺流漂动并引起栓塞的危险。 
已经提出了包含经皮缝合穿刺点的另一技术，诸如在授予Hathaway等人的美国专利号为5,304,184中所描述的。然而，经皮缝合设备将需要用户有显著的技能，并在制造上机械性复杂且很昂贵。 
已经提出了卡钉和手术回针来闭合组织上的伤口或其他开口。例如，授予Brown的美国专利号为5,007,921和5,026,390公开了可用于闭合伤口或切口的卡钉。在一个实施例中，公开了包括将倒钩衔接伤口另一侧组织的“S”形卡钉。在另一实施例中，公开了包括从环上突出倒钩的环形卡钉。然而，这些卡钉具有较大的截面轮廓，因此不易通过经皮点传送以闭合血管壁上的开口。 
授予Lee的美国专利号为6,033,427公开了用于密封内部穿刺点的方法和设备，其在一个实施例中使用双腔反流系统，其中远端反流部位彼此轴向隔离使得当密闭装置位于某一位置时，将会反流穿过其中一个腔，而不会穿过另一个腔。 
另外，已经提议了可旋入皮肤上开口的皮肤密封。例如，授予Rudd等人的美国专利号为5,645,565公开了可旋入穿刺处以密封该穿刺的手术塞。该手术塞包括增大的帽和从该帽延伸的螺纹杆。在内窥镜操作中，将塞子通过皮肤旋入开口直到帽衔接皮肤的表面。该塞子意旨密封沟通体腔的开口以防止喷洒流体从体腔中泄漏。然而，这种塞子仅可用在皮肤的表面，并不能引入穿过组织，例如来密封血管或其他皮下区域壁上的开口。 
已经提议了各种方法和装置用于确定关闭设备远端的位置，包括诸如在授予Magro等人的美国专利号为4,738,658中的“反流”方法。然而，已经构建的在先的反流设备使得在布置密封装置期间血液从患者流出持续了比希望更长的时间。 
在公布的美国专利申请2004/0019330中公开了反流技术进一步的发展，其中具有增大远端的控制元件即用于控制流过血管穿刺处的血流，又用于通过从血管腔中回撤进到血管壁内穿刺的增大远端来提供插管器护套远端位置的指示使得根据该公布的申请可阻止反流。 
Leschinsky专利号为5,871,501公开了在导线上使用锚以提供血管壁位置的指示来辅助放置止血材料以阻断血流流出血管上的穿刺。 
虽然已经提议了这些和其他方法及设备来布置塞子以阻止血流从血管上的穿刺处流出，但是仍需要为实现该目的所采用的布置塞子的安全且有效的设备 和方法。 
发明内容
本发明关注能够定位被穿刺的血管并密封该血管上的穿刺的设备，以及使用该设备的方法。该设备利用了在接近所需位置上使用关闭特征来指示密封元件位置的这一“反流”特征。接着使用基于导线的系统来更精确地定位密封元件。在一个优选实施例中，该设备包含传送管，其为狭长部件的形状具有从其远端区域上一点延伸到其近端区域上一点的管腔。该管腔在其近端和远端区域处连接到狭长部件的近端和远端端口从而产生从该管腔到狭长部件外表面的导管形状。在这一实施例中，该狭长部件还设有保持在其远端端口处狭长部件内的可分离密封元件。为了实现密封沟通身体管腔，诸如血管的穿刺或其他开口，该密封元件可以是生物吸收的毡、水凝胶或其他适合的材料。将近端和远端端口充分地隔开很远从而当远端端口在被穿刺血管管腔中时，近端端口在患者身体之外。 
该设备还在狭长部件的管腔中设有密闭装置，其密闭装置具有相对较大直径的远端部分，其连接到具有更窄直径的杆上。将狭长部件中的远端端口定位在最接近密闭装置的较大直径部分处。在这一优选实施例中，密闭装置的远端部分和杆具有共同的中央管腔并且密闭装置的远端部分外表面设有基本平行于密闭装置轴的凹槽。该设备还设有穿过密闭装置远端部分外表面上的凹槽的导线和穿过密闭装置中央管腔的拴绳。该导线在其远端具有特殊的构造并在其近端区域设有指示装置。这些特征便于该设备能够将密封元件布置在基本精确的位置上。一旦到达这一位置，将狭长部件回撤一小段距离并将密闭装置保持静止以便从狭长部件中射出密封元件。 
拴绳，其穿过密闭装置的中央管腔，以任何适当的方式，例如通过缠绕、打结和/或将拴绳的远端围绕该密封元件系缚或系到该密封元件上从而栓到或连接到密封元件上。 
使用中，本发明的设备可用于闭合象已经执行了导管插入术后的股动脉上的穿刺伤口。典型的，将本发明的设备引入穿过设有凸缘或其他装置适于衔接该设备并提供进一步远端移动及优选用于导管插入操作的插管器护套中。当如此使用时，该设备穿过插管器护套直到密闭装置远端处的密封元件和狭长元件内的远端端口位于股动脉的管腔中。用户将会知道当已经出现这一情形时，此 时插管器护套上的衔接装置阻止该设备进一步的远端移动。当这一情形出现时，血液将从近端端口涌现出来，因为当远端端口抵达血管，诸如股动脉的管腔时，血液将从血管中穿过远端端口流入并穿过狭长部件的管腔从近端端口流出。 
接着，将设备和护套一起回撤一小段距离使得远端端口不再位于股动脉的管腔中，并且血流基本上被患者的组织和密封元件阻断而不能抵达远端端口。 
用户将会知道当密封元件接近所需位置时，它立刻引起流出近端端口的血液停止或大量地减少。在这一点上，密封元件大约位于所需的位置上。接着回撤该设备直到栓在传送管近端部分的盘接触到栓于导线近端部分的盘，此时密封元件最终处于所布置的位置上。 
将栓于导线上的盘和栓于传送管上的盘隔开一小段距离并允许密封元件比别的可能方式更精确地定位。然而，值得注意的是优选这种盘的使用，但是也可使用其他结构来实现同样的目的。 
接着将导线回撤到密闭装置凹槽内的导线管中，而将设备的剩余部分保持在适当的位置。直到这时，密封器件位于所需的位置上并可通过将狭长部件回撤一小段距离进行布置，而密闭元件将基本位于狭长部件的远端。导线的远端将在导线管和狭长元件的管腔中，接着将密闭元件和导线作为一体从患者中回撤。栓绳将保留与密封元件的连接并能用于在将密封元件从指向血管穿刺组织的管域中移走时，拉回密封元件。 
如果将本发明的设备穿过插管器护套进行传送，优选地提供连接设备使得当狭长元件的远端位于血管管腔内时，护套和设备将变得彼此栓缚。如果此项完成，则作为一体的设备和护套的回撤将象把远端端口维持在护套远端位置一样是很方便的。 
在优选的实施例中，密封元件从可扩展的材料，诸如由直立的聚乙二醇酸(PGA)(由于其毡的结构)制成的毡来制造，接着进行扩展以确保穿刺伤口的有效闭合。可替代的，密封元件可由水凝胶，诸如藻朊酸羟纤维素(HPC)多微孔水凝胶制造。还可将密封涂覆有或其他设有促进凝结的止血材料。 
上面描述已经关注于密封股动脉上的穿刺伤口，但是应当理解的是本发明的设备可用于定位其他血管的管腔并用于密封它们上的穿刺伤口。为了理解，我们开始本发明更详细地描述。 
附图说明
图1是本发明设备的示意性阐述。 
图2是从A-A线看去，图1所阐述设备的截面图。 
图3阐述了具有其远端插入到血管管腔中的本发明的设备。 
图4显示了此时基本上已经从血管管腔中回撤的本发明的设备。 
图5显示了此时密封已经正确定位的本发明的设备。 
图6显示了在已经将密封推入到组织管域中后的本发明的设备。 
图7阐述了图1中所示设备的栓绳。 
图8阐述了在其近端具有更多细节的本发明的设备。 
图9阐述了本发明近端另外的细节。 
图10阐述了该设备把手上的狭缝。 
图11阐述了本发明设备的分解透视图。 
图12A和12B阐述了图11中所示设备的部分，在其近端具有附加的细节。 
图12C阐述了轻轻定位特征的另外的细节。 
图12D阐述了从D-D线看去图12A中所述的设备的截面图。 
发明具体实施方式 
图1阐述了本发明设备许多特征的相当示意的形式。设备10包括设有远端端口12和近端端口13的传送管11。密闭装置14罩在传送管11内并包含杆20和直径增大的远端部分21。设备10还设有横向延伸到远端16的导线15。该设备还设有密封元件17，其优选由毡、水凝胶或其他材料制成用于密封与身体管腔，诸如血管沟通的穿刺或其他开口。 
图2是从A-A线看去图1所示设备的截面图。如从图2中所见，密闭装置14的远端部分21设有用作导线15穿过通道的凹槽18。另外，密闭装置14设有从其远端延伸到其近端并用作栓绳(未显示)穿过通道的管腔19(未在图1中显示)。 
图3阐述了具有将其远端部分插入到血管23的管腔22中的设备10。如所见，该设备延伸穿过从患者皮肤25延伸到血管壁上穿刺26的管域24。当如此定位后，设备的反流特征，其包含传送管11上的远端端口12、传送管11上的管腔27和传送管11上的近端端口13，发挥了指示用户将传送管11的远端部分定位在血管管腔内的功能，因为可以看见血液从近端端口13流出。 
图4阐述了在包括其远端端口12的远端部分已经从血管23的管腔22的内 部回撤之后的设备10。当设备处于图4中所阐述的位置时，患者的组织和密封材料17基本上已经缩小了或者防止了血流从抵达远端端口12和近端端口13。因此，用户将从端口13流出血液的明显减少知道密封材料17位于布置的大约合适的位置。然而，在布置密封材料17之前，优选地采取附加的定位步骤。 
参考图4，可以看出导线横向延伸的远端部分16在设备10回撤的这一阶段没有接触到血管壁。 
接着参考图5，可以看出已经开始将导线的远端部分16接触血管壁23，另外，由于壁所施加给远端部分16的压力已经将导线的远端部分16重新装配。用户可感觉到导线远端部分与血管壁间的接触，因为存在对导线15近端移动的阻抗。这一接触还可通过利用合适的装置，诸如通过荧光透视法观看导线远端部分16的变形来确定。这一情形的发生可用于为密封元件17的布置而实现设备的最终定位，如下面更充分地描述。 
如图6中所示，通过向近端回撤传送管11来布置密封材料17，而同时保持密闭装置14的静止。这引起从管11中射出密封材料17并将它放置在血管管域24中靠近穿刺26的所需位置上。还向近端回撤导线15使得其远端部分16穿过凹槽18并存在于传送管11的管腔27中，或优选的，存在于延伸穿过管腔27长度的导线管34中(见图8)。优选的，管11的远端将与密闭装置14的增大部分21的远端齐平。接着通过将整个设备10从管域24中回撤，可将其从患者中去除。优选的，提供延伸穿过密闭装置14的中央管腔19的栓绳(未显示)并将其系在或以适当的其他方式栓到密封元件17上。该栓绳用作在存在任何需要将密封元件17从患者中回撤的情况下，给用户至少一个控制密封元件17的措施。这可简单地通过向近端拉动栓绳直到去除密封元件17来实现。 
图7中显示了将其末端部分打结在密封元件17上的栓绳28之间的关系，该图还显示了远端部分21和具有中央管腔19贯穿其中延伸的密闭装置14的杆20。如上所提到的，通过系缚、打结或任何其他合适的手段可将栓绳28固定在密封元件17上。图7中所示的代表是用于阐述的目的。 
现在参考图8，关于其近端结构更加详细地阐述了本发明的设备。图8显示了设有远端端口12和近端端口13以及将杆20和密闭装置的远端部分21罩在其管腔27中的传送管11内。传送管11还设有导线管34，其用作导线从设备的近端穿过密闭装置远端部分21上凹槽18的通道。还显示了密封元件17。 
还显示了制动器31，将其捆绑或以其他合适的方式栓于传送管11上。制动器31设有旋钮32，其具有与传送管11的近端端口13对准的管腔33。旋钮32可用作向近端或远端移动传送管11。使用中，向近端移动制动器31而保持密闭装置14静止使得一旦传送管已经被正确定位，密封元件17就从传送管11中射出。帽35设有密闭装置14的杆20可从其中穿过进行滑动的孔。将收缩管51的长度设成围绕杆20以便提供可滑动的密封。帽35还设有用于导线管34的孔，但是将导线管34捆绑或以其他合适的方式栓于帽35上使得制动器31的移动将引起传送管11和导线管34作为一体进行移动。在接近传送管11的近端提供粘合材料52以维持相对位置并相对于传送管11密封收缩管51和导线管34。 
制动器31还设有凹陷36，其优选为环形构造。凹陷36终止于底部37，如关于其他附图的更详细解释，该底部发挥弹簧座的功能。 
图9进一步阐述了设备的近端区域和除图8中所示元件之外的其他元件，其显示了凹陷36中的按钮38，其带有向近端方向上偏置按钮36的弹簧38。按钮38的近端设有管39，通过它导线管34可进行滑动。如图所示的手柄40，其围绕制动器31和按钮38。手柄40设有L形狭缝41，这在图10中有更完整地阐述，其中旋钮32能够移动。这一L形狭缝在图9中特别显示为元件41。固定到制动器31上的导线管34的近端部分设有制动器盘42。接近制动器盘42的是栓有导线15的导线盘43。制动器盘42和导线盘43被弹簧45隔开。 
图10中更详细地显示了手柄40中的L形狭缝41。从该图中可以看出，旋钮32即可在狭缝的短腿上横向移动到设备的纵轴，又可在狭缝的长腿上在轴向方向上移动。 
图11是本发明设备一个实施例的分解透视图。如在此所阐述的，可以看出手柄40包含上半部分46和下半部分47。手柄的上半部分46含有L形狭缝41。还显示了具有旋钮32和按钮38的制动器31，并且在L形狭缝41中接纳并保持旋钮32。具有远端端口12连通具有导线44远端部分的传送管11包含设备的远端部分。传送管11设有衬套48，当上下各半手柄46和47结合在一起时，其延伸进入手柄40的远端凹陷49中。制动器盘42连接到靠近其近端处的导线管34上，而导线盘43在接近制动器盘的点上连接导线。 
转到图12A-D，显示了关于制动器31和制动器盘42及导线盘43的附加细 节。在图12A-B中，显示了制动器31，其具有定位在远端的旋扭32和定位在其近端的按钮38。制动器31包含两部分，近端部分31a和远端部分31b(见图12B)。制动器的近端部分31a形成限制按钮38近端移动的内部垫肩31c。弹簧44(图12B)向近端方向上偏置按钮。导线管34带着定位在导线管34的管腔内的导线15在近端从制动器31延伸。制动器盘42连接到导线管34的近端，并且导线盘43在接近制动器盘42的点上连接导线14。 
参考图12C，将盘簧45设在制动器盘42和导线盘43之间。盘簧45提供力趋使将两个盘42、43分开，即盘簧45相对于彼此在远端偏置制动器盘42并向近端偏置导线盘43。 
图12D提供了关于设备近端部分的附加细节。如图所示，按钮38具有用于注入关于图9的上述粘合材料52的管腔53。密闭装置杆20连接到按钮38，如同穿过管39的导线管34和导线15能够滑动。也显示了制动器31a的近端，并在上面进行了充分地描述。 
现在将描述涉及制动器盘42和导线盘43操作的附加细节。制动器盘42和导线盘43用于提供在患者组织中所形成的管域24内密封元件17的最终、精确定位。如前面所述，导线盘43连接导线的14的近端口，而制动器盘42连接到导线管34，反过来，其连接到制动器31。两个盘42、43被隔开一小段距离，1，如图12C中所示。当设备10从血管管腔中回撤时，如上面所述，在将设备10的远端从血管中回撤的撤退期间，导线的远端部分16在一点上衔接血管壁23，例如，如图5中所示。在这一点上，反馈特征将出现没有发生大量反流的情形，这指示了该设备靠近了密封元件17带布置的位置。设备的持续撤退将引起导线15保持相对的静止，因为导线远端部分16衔接到血管壁。同时，制动器31、制动器盘43和设备10的剩余部分将继续向近端移动。当制动器盘43衔接导线盘42，即，当设备已经从衔接血管壁的导线远端16回撤一附加距离-1-时，指示了最终的布置位置。在这一点上，布置密封元件17。 
如上所述，通过引起传送管11相对于密闭装置14向近端移动实现密封元件的布置。这通过在L形狭缝41中轴向滑动旋钮32来实现。因为旋钮32结合制动器31，这一轴向移动引起制动器31和传送管11向近端前进。同时，密闭装置14保持在适当的位置，因此在所选的位置上布置密封元件17。当按钮38的近端衔接手柄40的内部表面时，制动器31能够在手柄40内对抗按钮弹簧44 的弹力向近端移动。这样，连接制动器31的传送管11能够相对于制动器14轴向移动。 
虽然本发明易于进行各种修改及替代的形式，其特定的例子已经在附图中显示并在此详细地进行了描述。然而，应该理解的是本发明并不限于所描述的特定形式或方法，相反，本发明覆盖所有落在附加权利要求精神和范围内的修改、等同物及替代物。 

Claims (20)

1.一种用于密封身体内腔的壁中的穿刺孔的设备，包括：
长型部件，其具有远侧端口，近侧端口，和连接所述远侧端口和近侧端口的通道，
延伸穿过至少一部分所述长型部件的闭塞装置，所述闭塞装置具有远侧部分，当所述长型部件向近侧回撤时，所述远侧部分适于选择性地防止密封部件在近侧方向上移动以释放密封部件来密封身体内腔的壁中的穿刺孔，其中所述闭塞装置的远侧部分比所述长型部件的远侧端口位于更远侧，以及
延伸穿过所述长型部件的引导线，所述引导线在远侧区域具有横向布置的部分，所述远侧区域具有足够的柔性向近侧回撤。
2.如权利要求1所述的设备，其中，所述密封部件位于该闭塞装置的远侧部分的远侧。
3.如权利要求1所述的设备，进一步包括延伸穿过所述长型部件内的内腔的引导线管，其中，所述引导线保持在所述引导线管中。
4.如权利要求1所述的设备，进一步包括连接至所述长型部件的致动器，所述致动器适于方便所述长型部件相对于所述闭塞装置的移动。
5.如权利要求1所述的设备，其中所述引导线的远侧区域的横向布置的部分接合身体内腔的壁以指示密封部件的位置。
6.如权利要求1所述的设备，其中所述长型部件是管状结构并且所述远侧端口是所述管状结构的侧面中的孔。
7.一种用于密封身体内腔的壁中的穿刺孔的设备，包括：
长型部件，其具有远侧开口、远侧端口，近侧端口，和连接所述远侧端口和近侧端口的通道，
延伸穿过至少一部分所述长型部件的闭塞装置，所述闭塞装置具有远侧部分，当所述长型部件向近侧回撤时，所述远侧部分适于选择性地防止密封部件在近侧方向上移动以释放密封部件来密封身体内腔的壁中的穿刺孔，其中所述闭塞装置的远侧部分比所述长型部件的远侧端口位于更远侧，以及
延伸穿过所述长型部件的远侧开口的引导线，所述引导线在远侧区域具有横向布置的部分，所述远侧区域具有足够的柔性向近侧回撤。
8.如权利要求7所述的设备，其中，所述密封部件位于该闭塞装置的远侧部分的远侧。
9.如权利要求7所述的设备，进一步包括延伸穿过所述长型部件内的内腔的引导线管，其中，所述引导线保持在所述引导线管中。
10.如权利要求9所述的设备，其中所述引导线管相对于所述长型部件是静止不动的。
11.如权利要求7所述的设备，进一步包括连接至所述长型部件的致动器，所述致动器适于方便所述长型部件相对于所述闭塞装置的移动。
12.如权利要求7所述的设备，其中所述长型部件防止流体进入所述远侧开口。
13.如权利要求7所述的设备，所述远侧端口是所述长型部件管状结构的侧壁中的孔。
14.一种用于密封身体内腔的壁中的穿刺孔的设备，包括：
长型部件，其具有远侧开口、远侧端口，近侧端口，和连接所述远侧端口和近侧端口的通道，
延伸穿过至少一部分所述长型部件的闭塞装置，所述闭塞装置具有远侧部分，当所述长型部件向近侧回撤时，所述远侧部分适于选择性地防止密封部件在近侧方向上移动以释放密封部件来密封身体内腔的壁中的穿刺孔，其中所述闭塞装置的远侧部分比所述长型部件的远侧端口位于更远侧，以及
延伸穿过所述长型部件的远侧开口的引导线，所述引导线在远侧区域具有环形部分，其限定的平面相对于所述引导线的近侧区域横向布置，所述远侧区域具有足够的柔性向近侧回撤。
15.如权利要求14所述的设备，其中，所述密封部件位于该闭塞装置的远侧部分的远侧。
16.如权利要求14所述的设备，进一步包括延伸穿过所述长型部件内的内腔的引导线管，其中，所述引导线保持在所述引导线管中。
17.如权利要求14所述的设备，进一步包括连接至所述长型部件的致动器，所述致动器适于方便所述长型部件相对于所述闭塞装置的移动。
18.如权利要求14所述的设备，其中所述密封部件防止流体进入所述远侧开口。
19.如权利要求14所述的设备，其中所述远侧端口是所述长型部件管状结构的侧壁中的孔。
20.如权利要求14所述的设备，其中所述引导线的远侧区域处的环形部分基本是圆形。
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