CN1911188A - 术中支架假体以及输送器 - Google Patents

术中支架假体以及输送器 Download PDF

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CN1911188A
CN1911188A CNA2005100286160A CN200510028616A CN1911188A CN 1911188 A CN1911188 A CN 1911188A CN A2005100286160 A CNA2005100286160 A CN A2005100286160A CN 200510028616 A CN200510028616 A CN 200510028616A CN 1911188 A CN1911188 A CN 1911188A
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prosthese
blood vessel
artificial blood
window
height trestle
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CN1911188B (zh
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可大年
孙立忠
张一�
罗七一
梅奇峰
向勇刚
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Shanghai Minimally Invasive Heart Vein Medical Technology Co., Ltd.
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Microport Medical Shanghai Co Ltd
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Priority to CN2005100286160A priority Critical patent/CN1911188B/zh
Priority to EP12153365.7A priority patent/EP2471491A3/en
Priority to EP12153368.1A priority patent/EP2450007A3/en
Priority to EP05792175A priority patent/EP1913897A4/en
Priority to PCT/CN2005/001537 priority patent/WO2007016821A1/zh
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Abstract

本发明公开了一种血管外科手术中用的术中支架假体以及用来输送这种支架假体的输送器，本发明术中支架假体包括人造血管假体和自弹式血管支架，所述自弹式支架固定设置在人造血管假体内，自弹式支架的外壁与人造血管假体的内壁相接触，所述人造血管假体的一端端部比自弹式支架的相对应端部长。其输送系统可以是鞘管式输送器也可以是线绑式输送器。采用本发明支架假体用于主动脉瘤变外科手术，特别适用于治疗手术中从手术开口不能触及到的主动脉病变，本发明术中支架假体能与普通手术用的人造血管假体缝合，也可与人体血管缝合，从而扩大了手术区，使传统的需两次完成的手术可以一次完成，提高了手术效率。

Description

术中支架假体以及输送器
技术领域
本发明属于血管外科手术中使用的血管内植入物以及植入器械，具体地说，涉及一种术中支架假体以及用来输送这种支架假体的输送器。
背景技术
在传统的医疗技术中，用正主开胸手术治疗胸主动脉瘤病变，包括升主动脉、弓部和降主动脉。在手术中用人造血管假体替代病变的主动脉血管。但在正中开胸手术中降主动脉被心脏挡住难以触及，故对于这段血管的病变传统的方法是将一般人造血管从降主动脉切口处插入(俗称象鼻子)。这段血管的作用是便于和二次手术(一般从第四左肋处开胸)连接。这样多数病人就须接受二次手术，在一次手术与二次手术之间，病人将承受较大风险。
发明内容
本发明所要解决的技术问题是提供一种术中支架假体以及用来输送这种支架假体的输送器，以克服现有技术存在的上述缺陷，一次完成全部手术。
本发明解决技术问题的技术方案如下：
一种术中支架假体，其特征在于，包括人造血管假体和自弹式血管支架，所述自弹式支架固定设置在人造血管假体内，自弹式支架的外壁与人造血管假体的内壁相接触，所述人造血管假体的一端端部比自弹式支架的相对应端部长。自弹式支架可以通过缝合等方式与人造血管假体固定。人造血管假体长出支架的一端可以便于与其他血管或血管假体的对应部位缝合。
作为本发明的进一步改进，所述人造血管假体的两端端部均比自弹式支架的相对应端部长。
作为本发明的进一步改进，所述支架假体上设有窗口，所述窗口将人造血管假体与自弹式支架分成独立的左右两段，左右两段自弹式血管支架之间通过合金丝连接，所述合金丝的弯曲度与人造血管相同且相应于窗口处裸露透过窗口可见。
作为本发明的进一步改进，所述人造血管假体上与自弹式支架重合处设有窗口，所述自弹式支架相应于窗口处裸露且透过窗口可见。所述窗口可以为椭圆形窗口，也可以为其他形状窗口，还可将中间段的人造血管假体全部取消。
所述窗口沿人造血管环向呈圆柱状设置，所述窗口使人造血管分成独立的左右两段，所述支架于相应窗口处裸露可见。
作为本发明的另一种改进，所述人造血管假体带有1～3个血管分支。相应的也可以在每个血管分支内设置血管支架。
所述人造血管假体的材料选自PET或PTFE，所述支架采用弹性好、生物相容性好的金属材料制成，可以选自NiNi形状记忆合金、CoCr合金或316L/317L不锈钢等材料。
本发明的另一个目的是提供一种用于输送上述术中支架假体的输送器，包括手柄、拉杆和拉线，手柄的一端带有管状口，所述拉线的一端固定在拉杆上，另一端固定在手柄上，所述支架假体一端插入管状口并通过拉线绑在拉杆上，所述拉杆从手柄管状口中穿过，其特征在于，还包括带有导丝孔的芯棒，所述芯棒的头部设有子弹型导入头，所述手柄带有通孔，所述芯棒末端固定设置在手柄孔内，外来导丝可穿过导丝孔从导入头伸出。子弹型导入头使得术中支架假体传入病变血管变得容易，还能保护血管不受损伤；当血管真腔口被压得很小时，可先借助导丝穿入病变，在将芯孔穿在导丝外沿导丝穿入，从而保证了操作的方便和可靠。
作为对上述输送器的进一步改进，所述输送器还包括手枪状输送器主体，所述手柄末端与枪口处固定连接，所述拉杆的末端与手枪的扳机固定连接。这样可以在手术过程中通过扳动手枪扳机，即可使支架假体在输送以及释放过程由双手操作变为单手操作，另一只手可用手术工具固定浮动的主动脉血管切口，从而使输送及释放操作更加容易，准确，提高手术时间和效率。
本发明术中支架假体还可以采用鞘管式输送系统输送，所述输送器包括外鞘管、推送杆，还包括带有导丝孔的芯棒，所述芯棒的头部设有子弹型导入头，所述芯棒的尾部伸入推送杆内部且与推送杆固定连接，所述推送杆内设有可供外来导丝穿过的通孔，外来导丝可穿过导丝孔从导入头伸出。子弹型导入头使得术中支架假体传入病变血管变得容易，还能保护血管不受损伤；当血管真腔口被压得很小时，可先借助导丝穿入病变，在将芯孔穿在导丝外沿导丝穿入，从而保证了操作的方便和可靠。
作为对上述鞘管式输送器的进一步改进，还包括手枪状输送器主体，所述外鞘管末端与输送器主体的枪口处固定连接，所述推送杆与手枪扳机固定连接。支架假体被预先压缩在外鞘管与芯棒之间，操作时将外鞘管插入处理的主动脉切口，用一手固定推送杆的手柄，另一手将输送鞘管向后撤出，支架假体会从外鞘管中释放出来并自动弹开，剪齐动脉血管切口使其与术中支架端面平齐并重叠，将另一段置换主动脉的人造血管与这一重叠口缝合，完成手术。
本发明与现有技术相比的有益效果如下：
本发明通过在人造血管假体内设置血管支架，改变了原有手术时必须在升主段另外用人造血管假体取代病变血管，再与术中支架缝合的操作方式，且不需缝合，不仅节省了手术费用，而且也节省了手术时间，使手术变得更加简单。而且手术时可不用将病变的人造血管剪去，仅需在主动脉处开切口将支架插入即可。此外，中部裸露式支架假体可以使其裸段对准弓部三个分支，或将三分支假体的三个分支插入人体主动脉弓部的三个分支血管，其前段带膜部分对应升主段，后段带膜部分对应降主动脉，从而起到了人造血管及术中支架的联合作用，提高手术效率，节省费用。用合金丝连接的带窗口的术中支架假体由于省去了窗口部的支架，还可减少支架对血管壁的刺激。
本发明支架假体具有结构简单、使用方便操作性能可靠等优点，在血管中能保持良好的几何形状，有良好的机械性能及生物相容性；而且多种结构可适应不同的病变。不仅可一次手术中完成两次手术的操作内容，而且可以节省一次手术的时间。
附图说明
图1是本发明术中支架假体结构示意图；
图2是中部全部裸露合金丝连接的术中支架假体结构示意图；
图3是中部全部裸露的术中支架假体结构示意图；
图4是中部部分裸露的术中支架假体结构示意图；
图5是带有3个血管分支的支架假体结构示意图；
图6是线绑式输送器结构示意图；
图7是手枪型线绑式输送器结构示意图；
图8是手枪型鞘管式输送器结构示意图；
图9是本发明支架假体用于降主动脉实例示意图；
图10是本发明支架假体用于腹主动脉实例示意图；
图11是本发明中部全部裸露的术中支架假体用于弓部实例示意图；
图12是本发明中部部分裸露的术中支架假体用于弓部实例示意图；
图13是本发明带有3个分支的术中支架假体用于弓部实例示意图。
具体实施方式
下面结合附图与实施例进一步说明本发明。
参见图1，本发明术中支架假体，包括人造血管假体2和自弹式血管支架1，所述自弹式支架1固定设置在人造血管假体2内，自弹式支架的外壁与人造血管假体的内壁相接触，所述人造血管假体2的一端端部比自弹式支架1的相对应端部长L，L的长度可以为10mm左右。也可以人造血管假体2的两端端部均比自弹式支架1的相应端部长。
参见图2，作为本发明的进一步改进，所述术中支架假体上设有窗口204，所述窗口204将人造血管假体2分成独立的左右两段201、202，窗口204将自弹式支架1分成独立的左右两段101、102，左右两段自弹式血管支架101、102之间通过合金丝103连接，所述合金丝103的弯曲度与人造血管2相同且相应于窗口204处裸露透过窗口204可见。
参见图4，作为本发明的进一步改进，所述人造血管假体2上与自弹式支架1重合处设有窗口204，所述自弹式支架相应于窗口处裸露且透过窗口可见。所述窗口204为椭圆形窗口。
参见图3，作为本发明的进一步改进，所述窗口沿人造血管环向呈圆柱状设置，所述窗口使人造血管分成独立的左右两段201和202，所述自弹式支架1相应于柱状窗口处裸露可见。
作为进一步改进，如图5所示，所述人造血管假体可以带有1～3个血管分支203。相应的也可以在每个血管分支内设置血管支架104。
所述自弹式支架为Z型结构或编织结构，支架可以向一个方向弯曲也可以向多个方向弯曲以顺应弯曲的血管。
人造血管的材料可以为PET、或PTFE，人造血管的表面可以是平整的也可以是波纹状的。
参见图6，本发明用于输送上述术中支架假体的输送器，包括手柄3、拉杆4和拉线5，手柄的一端带有管状口301，所述拉线5的一端固定在拉杆4上，另一端固定在手柄3上，所述支架假体6一端插入管状口301并通过拉线5绑在拉杆4上，所述拉杆4从手柄管状口301中穿过，还包括带有芯孔的芯棒7和导丝8，所述芯棒7的头部设有子弹型导入头9，所述手柄3带有通孔，所述芯棒7末端固定设置在手柄孔内，外来导丝8可穿过芯孔从导入头9伸出。拉杆4为不锈钢丝，拉杆的尾端带有圆环拉手401。操作时将术中支架假体6插入要处理的主动脉切口，一手固定手柄，另一手拉出不锈钢丝拉杆4，支架会被释放同时自动弹开，从手柄管状口301中脱出。
如图7所示，作为对上述输送器的进一步改进，所述输送器还包括手枪状输送器主体10，所述手柄3末端与输送器主体枪口处11固定连接，所述拉杆4的末端与手枪的扳机12固定连接。使用时扳动扳机即可将支架逐步释放并弹出。整个过程单手操作即可完成。
如图8所示，本发明术中支架假体还可以采用鞘管式输送系统输送，所述输送器包括外鞘管3、推送杆4，还包括带有导丝孔的芯棒7，所述芯棒7的头部设有子弹型导入头9，所述芯棒7的尾部伸入推送杆4内部且与推送杆4固定连接，所述推送杆4内设有可供外来导丝8穿过的通孔，外来导丝8可穿过导丝孔从导入头9伸出。也可以对上述鞘管式输送器进行改进，增加一个手枪状输送器主体10，将所述外鞘管3末端与输送器主体的枪口11处固定连接，将所述推送杆4与手枪扳机12固定连接。所述术中支架假体6压缩在外鞘管3与芯棒7之间，操作时，将外管3插入处理的主动脉切口，扳动扳机12使推送杆4顶住支架假体6，输送器外鞘向后撤，支架6会在外鞘管3中逐渐释放出来并自动弹开。剪齐动脉血管切口使其与术中支架假体端面平齐并重叠，将另一段置换主动脉的人造血管与这一重叠口缝合，完成手术。
实施例1
参见图9所示，病人患有胸主动脉瘤病变，包括升主段，弓部和降主段。对他进行了正中开胸手术，将升主动脉段与弓部用带有三分支的人造血管假体13置换；人造血管假体的一端与升主动脉切口缝合；将术中支架假体14插入降主动脉切口并使之释放弹开；将术中支架与降主动脉切口重叠口与人造血管的另一端口缝合。将人造血管的三个分支与对应的分支血管(即头臂动脉、胫总动脉及左锁骨下动脉)分别缝合，完成全部手术。
实施例2
参见图11、图12所示，病人患有胸主动脉瘤病变，包括升主动脉、弓部和降主动脉，对患者实施了正中开胸手术，在升主动脉处作切口，从切口将图2和图3所示的术中支架假体14插向降主动脉部，使术中支架中部裸露的部分正对着主动脉弓部的三个支脉，如图11和12所示，将术中支架与开主动脉切口重叠口与升主动脉通心脏边的切口缝合，完成全部手术。
实施例3
参见图10所示，病人所患的是包括降主动脉与腹主动脉的主动脉瘤病变，且病变波及左锁骨下动脉。对病人实施了左肋下第四肋骨处开胸手术，用带一个分支的人造血管将降主动脉处的病变血管取代，并分别与对应的主动脉弓部切口及左锁骨下动脉切口缝合，在腹主动脉切口处插入图1所示的术中支架并将其释放，如图10所示；将术中支架与腹主动脉切口重叠，再与人造血管的下端缝合，完成全部手术。
实施例4
参见图13所示，病人患有胸主动脉瘤病变，包括升主动脉、弓部和降主动脉，对患者实施了正中开胸手术，在升主动脉处作切口，从切口将图2，图3或图4所示的术中支架假体14插向降主动脉部，使术中支架中部的三个分支插入主动脉弓部的三个支脉，如图11和12所示，将术中支架与开主动脉切口重叠口与升主动脉通心脏边的切口缝合，完成全部手术。

Claims (11)

1.一种术中支架假体，其特征在于，包括人造血管假体和自弹式血管支架，所述自弹式支架固定设置在人造血管假体内，自弹式支架的外壁与人造血管假体的内壁相接触，所述人造血管假体的一端端部比自弹式支架的相对应端部长。
2.根据权利要求1所述的术中支架假体，其特征在于，所述人造血管假体的两端端部均比自弹式支架的相对应端部长。
3.根据权利要求1所述的术中支架假体，其特征在于，所述支架假体上设有窗口，所述窗口将人造血管假体与自弹式支架分成独立的左右两段，左右两段自弹式血管支架之间通过合金丝连接，所述合金丝的弯曲度与人造血管相同且相应于窗口处裸露透过窗口可见。
4.根据权利要求1所述的术中支架假体，其特征在于，所述人造血管假体上与自弹式支架重合处设有窗口，所述自弹式支架相应于窗口处裸露且透过窗口可见。
5.根据权利要求4所述的术中支架假体，其特征在于，所述窗口沿人造血管环向呈圆柱状设置，所述窗口使人造血管分成独立的左右两段，所述支架相应与柱状窗口处裸露可见。
6.根据权利要求1所述的术中支架假体，其特征在于，所述人造血管假体带有1～3个血管分支。
7.根据权利要求1至6任一项所述术中支架假体，其特征在于，所述人造血管假体的材料选自PET或PTFE，所述支架的采用弹性金属材料制成，选自NiNi形状记忆合金、CoCr合金或316L/317L不锈钢之一。
8.一种用于输送权利要求1至7所述的术中支架假体的输送器，包括手柄、拉杆和拉线，手柄的一端带有管状口，所述拉线的一端固定在拉杆上，另一端固定在手柄上，所述支架假体一端插入管状口并通过拉线绑在拉杆上，所述拉杆从手柄管状口中穿过，其特征在于，还包括带有导丝孔的芯棒，所述芯棒的头部设有子弹型导入头，所述手柄带有通孔，所述芯棒末端固定设置在手柄孔内。
9.根据权利要求8所述的输送器，其特征在于，还包括手枪状输送器主体，所述手柄末端与枪口处固定连接，所述拉杆的末端与手枪的扳机固定连接。
10.一种用于输送权利要求1至7所述的术中支架假体的输送器，包括外鞘管、推送杆，其特征在于，还包括带有导丝孔的芯棒，所述芯棒的头部设有子弹型导入头，所述芯棒的尾部伸入推送杆内部且与推送杆固定连接，所述推送杆内设有可供外来导丝穿过的通孔。
11.根据权利要求10所述的输送器，其特征在于，还包括手枪状输送器主体，所述外鞘管末端与输送器主体的枪口处固定连接，所述推送杆与手枪扳机固定连接。
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CN112522496A (zh) * 2020-12-07 2021-03-19 北京泰杰伟业科技有限公司 一种用于血管支架预制成型的热处理夹具
CN112807142A (zh) * 2021-02-08 2021-05-18 周小彪 一种分支型主动脉人工支架输送装置

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EP1913897A1 (en) 2008-04-23
CN1911188B (zh) 2010-10-13
WO2007016821A1 (fr) 2007-02-15

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