CN1198540C - 以一预定方向向体内送入非对称装置的径向对准件 - Google Patents

以一预定方向向体内送入非对称装置的径向对准件 Download PDF

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CN1198540C
CN1198540C CNB018031641A CN01803164A CN1198540C CN 1198540 C CN1198540 C CN 1198540C CN B018031641 A CNB018031641 A CN B018031641A CN 01803164 A CN01803164 A CN 01803164A CN 1198540 C CN1198540 C CN 1198540C
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K·安普拉茨
M·阿弗勒莫夫
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Abstract

将一物体送进病人体内的一种装置和方法，其中，该物体相对于病人体内的送进位置以一较优选方向送进。所述送入装置有一对准件，该对准件允许物体经由(在)血管(内)送入病人体内的所需送入装置。其中，物体是以一有利的较佳方法送进的。所述物体可以是例如一非对称物体或该物体包括一结构，该结构在相对于所述要送进的位置只有一个合适的方向可以送入。这种物体可以例如是治疗病人体内的血管或器官的某些缺损或损伤的物体。

Description

以一预定方向向体内送入非对称装置的径向对准件
技术领域
本发明总的涉及将一物体送入病人体内，其中，该物体是相对于病人体内的某一位置是以一优选的方向发送的。更具体地说，本发明涉及一送入装置，该送入装置具有一径向对准件，它可以使被送入的物体经由血管内地送入到病人体内的某一位置，其中，物体是以一预定方向送入的。该物体例如可以是一非对称物体或包括一要求相对于所要发送的位置只要用一个方向送入的结构的物体。这样的物体例如可以用于治疗病人体内的血管或器官内的某些缺陷、损伤。
背景技术
多年来，在血管内发送的医疗装置一直用于治疗病人体内组织和器官的许多类型的缺陷。例如，心内的装置被用于治疗心脏的某些先天性缺陷包括心室中隔(隔膜)缺陷(VSD：延伸穿过在左右心室之间的中隔(隔膜)的缺损或穿孔)，心房中隔缺陷(ASD：延伸穿过在左右心房之间的中隔的缺损或穿孔)或病人的开放性动脉导管(PDA：肺动脉及主动脉之间开孔的不完全的闭合，它是在胎儿发育期间出现的)。这些缺陷可以导致血管不正常地在心室之间分流从而使血液中的氧气量不平衡以致产生青紫(发绀)症，心脏扩大、衰竭或其他并发症。
人们发展出了非侵入性的技术来治疗这些缺损。这些技术包括使用导管及导线以将堵塞(闭合)装置送入病人心脏内的需要填塞的部位。这些装置往往难于定位，并且如果是一个非对称的装置，那就难以以较佳的方位加以送入。例如PDA装置就一般都采用非对称的形状以与肺动脉和主动脉之间联通道角度相啮合。为了使这些非对称性的装置发生效用，必须以一种特定的方向将它在联通道内发送以使该装置的固定盘与主动脉壁平齐。作为另一个例子，室或心室膜周围中膜缺损一般非常接近主动脉瓣。为了闭合这些缺陷，固位机构必须是非对称性的，其中，固位盘从装置的中心偏移以使固位盘在主要部位的一侧比另一侧延伸出去更远些。盘的较小的部分或边缘向着主动脉瓣。
血管中的其他缺陷，例如可能要求把装置送进血管，其中，要求装置在血管内具有一特定的位置。例如该装置可能包括一个洞孔，或某些要求在血管中以一特定方向送入的特定结构。因此人们需要一种把一个物体送到指定位置的装置和方法，其中，该物体的方向是被控制着的。本发明能满足这些要求，而且对本专业领域的专业人员来说是很容易清楚的。
发明内容
本发明的装置适于把一个可折叠的物体送入病人体内的预先选定的区域。一种细长的推进导管，例如，可以改变一下以在它的远端包括一具有一径向对准件的远端端部，此径向对准件适于与可折叠物体的连接件配合。此细长的推进导管还可以有一预定的弯曲或弯曲部，以与发送护套的形状或弯曲部相配合，该形状或弯曲部粗粗地与要发送到的位置附近的血管的形状或弯曲部相配合。在细长形推进导管的发送过程中，导管可以旋转以使导管的弯曲部倾向于与血管中的弯曲部相对准。当可折叠物体安装在细长推进导管的远端端部的固定位置上时，可折叠物体的方向相对于推进导管的弯曲部是已知的。这样，当细长推进导管被发送时，可折叠物体的方向相对于发送导管及要发送到的位置处的血管的弯曲部是已知的。正确的方向可以通过在推进导管及发送导管上采用相同的弯曲部或者防止发送导管中的发送推进器的旋转而实现正确的发送方向。
在较佳实施例中，推进导管包括一管腔，该管腔在近端和远端之间延伸，其中，远端端部包括一穿过并与管腔对准的洞孔，一导索延伸穿过推进导管的管腔，其中，导索的一远端延伸穿过远端端部的孔并且可与折叠物体相连。该导索的远端包括一带螺纹的外表面以及可折叠物体包括一具有适于容纳该导索的带螺纹的外表面的螺纹内孔的构件。但这并不一定要这样的安排，本技术领域的专业人员将理解，其他把诸物体可拆开地紧固在一起的方法也可以用于远端端部及可折叠物体，这并不越出或背离本发明的范围。
推进导管的远端部还包括一具有一预定形状的径向对准件。可折叠物体的连接件包括一相应的匹配的形状，从而使可折叠物体只可能对准并与径向对准件在一个方向上相啮合。例如，当然不一定限于这个例子，径向对准件的形状可以是一个具有一个倾斜的角的半圆形或一个矩形，一等腰三角形或其他形状，只要它们只允许一个匹配方向就行。径向对准件及连接件之间的啮合阻止可折叠件围绕远端端部旋转。
在使用时，一非对称物体可以用本发明的装置送入病人体内。其中，该物体的方向是预先定好的。手术者先把非对称装置连到细长形推进导管上，其中，远端端部具有一径向对准件，该径向对准件适于非对称装置的一个连接件相配合。此装置可以包括射线透不过的指示器，它设置在非对称装置的一预定位置上。以这种方式，非对称装置的方向可以通过x射线透视法或其它已知观察方法加以确定。径向对准件的方向相对于推进导管的弯曲处是固定的。然后把一发送护套定位在病人血管内，其中，护套的一远端接近所希望的发送位置。该护套还可以有一个相应于接近所要求发到位置的血管形状的一预置弯曲部。或者，该推进导管及护套的内腔的形状形成得可以防止推进导管在护套内旋转。然后，手术者通过把径向对准件与推进导管中的弯曲部相联系的一个方向上相连，把连到推进导管上的非对称装置装进护套。然后把推进导管通过护套推进直到导管的远端端部伸出护套为止。然后，手术者可以确定可折叠物体是否正确定位，如果需要，把物体与径向对准件和推进导管的端部脱开啮合。此后，手术者可以已知的适当方式取出推进导管及护套。
附图说明
图1是本发明的细长形推进导管的立体图。
图2是图1中所示的细长形推进导管的立体图，导管的远端端部装上了一PDA装置。
图3是图2中的PDA装置的侧视图。
图4是一部分侧视图，图中示出了一非对称PDA装置被送入时符合主肺动脉和主动脉之间的联通道的角度。
图5是所述细长形推进导管的远端端部的部分立体图。
图6是图2中PDA装置的连接件的俯视图。
图7是另一个细长形推进导管实施例的远端端部的部分立体图。
图8是图2所示PDA装置的连接件的另一个实施例的俯视图。
图9是推进导管的剖视图。
图10是一截面图，图中示出了护套的内腔的形状，该护套适于容纳具有图9所示形状的推进导管。
图11是一部分剖面侧视图，图中示出了一非对称堵塞装置位于一周围膜心室隔膜缺损中。
具体实施方式
下面结合附图及权利要求书详细描述本发明的实施例，附图中凡是相同的部件均用相同的编号表示。本发明提供了对发送装置的可供给用的改进，并提供了把一物体以一预定方向送进病人体内的方法。应予理解的是，在此所详细叙述的实施例，其目的是作为其中可使用本发明的那些实施例的代表以用以说明本发明的例子，本发明并不局限于所描述的实施例。
本发明提供一细长推进导管10，该导管10可以通过一护套12并与一可以自展开的物体14以一预定的方向相连以送入病人体内。该可自展开的物体14具有一可以堵塞住一PDA的形状，然而，也不一定仅适于PDA的形状，本技术领域可以理解，该可自展开物体14可以具有不同的形状和尺寸。例如，该可自展开物体14可以结构成特别适合治疗ADD、VSD、PFO、用于修复腹部主动脉动脉瘤的三A移植片或其他可自展开物体的形状和方位显著的缺损。
该可自展开物体14最好是用包括多个编制金属股线的管状金属织物，当然也不限于这种材料。一夹持件16装在金属织物的每一外端，从而可防止金属织物的散开。至少夹持件16的一个适于连接到推进导管10的端部以送入病人体内的预先选定的位置。这将在下面作详细的叙述。
一旦选好了适当的治疗病人生理状况的可自展开物体14之后，一导管或其他适当的送入装置可位于病人身体的通道内以将送入装置10的远端置于所需要治疗位置附近。该发送或送入装置10可以促使可自展开物体通过一护套的管腔或在病人体内采的其他管子。当物体在护套的远端展开时，物体保持留在发送装置的端部，一旦证实自展开物体14已恰当定位在病人体内时，该推进导管10可以与自展开物体14脱离，接着把它抽出。通过将自展开物体14安装在推进导管上，手术者可以缩回物体14对之加以重新定位，如果发现物体定位不合适，甚至在推进导管10的端部外物体已展开时也可以重新定位。
在附图所示的一较佳实施例中，图中示出了该非对称医疗堵塞用的自展开物体14装载推进导管或发送装置10上面的。该推进导管10通常包括一细长、柔性、生物兼容的管子。该管子具有沿其纵向轴线的管腔。一导线或导索可以设置在该推进导管的管腔内，并延伸穿过推进导管的端部。导索的端部带螺纹并旋入夹持件的端部，从而把可自展开物体14固定在推进导管10上。推进导管10内的管腔的直径的尺寸做成导线可以在推进导管内旋转，但是又足够的贴合以避免导索内的纽结或绞缠。形成在推进导管的端部或远端的径向对准件包括一预定的形状，该形状与形成在夹持件内的形状相配合。其中，该径向对准件只和夹持件在一个方向上啮合。
推进导管10在近其远端处是弯曲的，其弯曲的形状取决于要把该装置经血管送到什么地方。例如，如果要使推进导管把一个堵塞装置送到PDA附近，那么，推进导管的弯曲形状要近似肺动脉和主动脉附近联通部之间的路径。下面将要详细叙述，固定在远端端部内的该形状的方向可加以控制以改变连在径向对准件上的可自展开物体的方位。推进导管的弯曲部有助于径向对准件把装置在一预定方向发送的能力。
现请参阅附图。本发明的推进导管10示意性地示于图1及图2。该推进导管10包括一细长管段18，该段具有一近端28和一远端30。一导索20延伸穿过管段18的管腔。管段18的远端30包括一径向对准件24，它固定在管子18的远端30上。该径向对准件24包括穿过它的一个孔26，其中，孔26的中心与管腔的中心彼此对准，导索20的远端上带螺纹，该导索远端延伸到管段18的远端的外面穿过径向对准件24的孔26，一手柄22装载导索的近端，它有助于导索在管状段18内的旋转。
图2和图4示出了连接在推进导管10上的可自展开物体14，该可自展开物体14包括一连接件或夹持件16，该连接件或夹持件16装在径向对准件24上(参见图3)。为了充分堵塞住主动脉和肺动脉之间的联通道，图3和图4中所示的物体14只有一个最佳的方向。突缘、边或称固位盘32从PDA装置的主圆筒形部分以一锐角延伸，这样，当突缘32靠在主动脉壁上时，主圆筒形部分34相对于邻近PDA的主动脉的纵向轴线以一角度延伸进入联通部。所述非对称物体14可以包括一射线通不过的指示器44，该指示器44安装在非对称装置14的一个预定位置上。这样，非对称装置14的方位就可以通过X射线或其他已知方法加以确定。
现请参阅图5及图6，图中示出了径向对准件24和夹持件或称连接件16的匹配形状。径向对准件24包括一突出部36，在突出部36的一段具有一半圆的形状，夹持件16包括一相应的形状，在夹持件内形成凹部38。该突出部36与凹部38相匹配，导索20的远端旋入夹持件16的带螺纹的内孔40之中。或者，突出部36可以从夹持件16伸出，凹部38可以形成在径向对准件内，如图7及图8所示。以这种方式，可自展开物体14可以相对于推进导管10以及，例如在管子段18的近端上的标记42，只可以以一个方向连接在径向对准件24上。这样，当物体14通过护套传送时，所附着的物体14的方向就可以知道(相对于标记)。发送护套12(见图4)位于病人身体的血管内，其中护套12的一远端则邻近所要求发送到的位置。护套12也可以有一个相应于推进导管10中的弯曲的一预设弯曲部。或者，推进导管10及护套12的内腔60的形状形成得可以防止推进导管10在护套12内转动(见图9及图10)。
图11示出了一堵塞物体46，图中，它的位置是堵塞一隔膜48中的室或心室膜周围中膜(隔膜)缺损。该填塞装置46是非对称的，它包括凸缘50及52。凸缘50及52啮合隔膜48并且围绕着缺陷处。一射线不能透过的指示件44在图中连在凸缘50上。以此方式，当堵塞装置46被送进时，装置46的位置是否合适可以确定，连接件16与推进导管10的径向对准件24相配合。如图11所示，径向对准件24及连接件16可以以所需方向发送非对称装置46，以凸缘52的较长的部分啮合离开主动脉瓣的隔膜。
在此，对本发明以相当具体的细节作了描述以符合专利法规的要求以及为本技术领域内的专业人员提供所需信息以应用新的原理，制作及使用本发明的实施例。但是，应予理解的是，本发明也可以以不同的装置来实施，而且在本发明的精神实质的范围内完全有可能对本发明上述实施例作出种种改变和变化。

Claims (14)

1.一种可以把一可折叠的装置送进病人体内一预选区域的送入装置，其特征在于，所述送入装置包括：
一细长的推进导管，该导管有一近端及一远端，所述远端包括一远端端部，其上具有一径向对准件，该径向对准件可用于与一可折叠装置的连接件相配合，其中，所述径向对准件的方位相对于所述细长推进导管的纵向轴线是预先确定的。
2.如权利要求1所述的送入装置，其特征在于，所述推进导管包括一在近端和远端之间延伸穿过细长推进导管的管腔，且其中，所述远端端部包括一延伸穿过并与管腔对准的孔。
3.如权利要求2所述的送入装置，其特征在于，它还包括一延伸穿过所述推进导管的管腔的导索，其中，所述导索的远端可延伸穿过所述远端端部的孔，并可连到可折叠装置上。
4.如权利要求3所述的送入装置，其特征在于，所述导索包括一带螺纹的外表面。
5.如权利要求1所述的送入装置，其特征在于，所述径向对准件具有一半圆的形状。
6.如权利要求1所述的送入装置，其特征在于，所述可折叠装置的连接件的方向相对于所述可折叠装置的形状是预先设定的。
7.如权利要求1所述的送入装置，其特征在于，所述径向对准件和连接件之间的匹配可以防止可折叠装置绕远端端部旋转。
8.一种适于把一可折叠装置送进病人体内一预选定区域的送入装置，所述送入装置包括：
一细长的推进导管，该导管有一近端及一远端，所述远端包括一远端端部，其上具有一装置，用以相对于所述远端端部的一预定方向径向地对准可折叠装置的一连接件，所述远端端部还包括使所述远端端部与所述连接件相配合的装置，其中，相对于远端端部的该预定方向还相对于固定于所述推进导管内的弯曲部是可调整的。
9.如权利要求8所述的送入装置，其特征在于，所述推进导管包括一在近端和远端之间延伸穿过细长推进导管的管腔，以及其中所述远端端部包括一从中延伸穿过并与所述管腔对准的孔。
10.如权利要求9所述的送入装置，其特征在于，它还包括一延伸穿过所述推进导管的管腔的导索，其中，所述导索的远端延伸穿过远端端部的孔并可与可折叠装置相连。
11.如权利要求10所述的送入装置，其特征在于，所述导索的远端包括一带螺纹的外表面。
12.如权利要求8所述的送入装置，其特征在于，所述对准用的装置具有一半圆形的形状。
13.如权利要求8所述的送入装置，其特征在于，所述可折叠装置的连接件的方向相对于可折叠装置的形状是预先设定的。
14.如权利要求8所述的送入装置，其特征在于，在对准用的装置和连接件之间的匹配可以阻止所述可折叠装置绕远端端部旋转。
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CN1394132A (zh) 2003-01-29
BR0110815A (pt) 2003-02-11
AU6162001A (en) 2001-11-26
ES2315284T3 (es) 2009-04-01
ATE404125T1 (de) 2008-08-15
EP1284656A4 (en) 2006-06-07
US20020029061A1 (en) 2002-03-07
KR100508469B1 (ko) 2005-08-17
US6402772B1 (en) 2002-06-11
KR20020094038A (ko) 2002-12-16
EA200201088A1 (ru) 2003-06-26
HK1049594A1 (zh) 2003-05-23
ZA200208841B (en) 2003-10-31
BR0110815B1 (pt) 2013-01-08
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AU2001261620B2 (en) 2004-03-11
DE60135323D1 (de) 2008-09-25
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US6334864B1 (en) 2002-01-01
CA2408943A1 (en) 2001-11-22
CA2408943C (en) 2005-11-08
BR0110815B8 (pt) 2013-02-19
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EP1284656A1 (en) 2003-02-26

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