CN106562840B - 一种将植入体装载到输送系统中的导引盖和装载系统 - Google Patents

一种将植入体装载到输送系统中的导引盖和装载系统 Download PDF

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CN106562840B
CN106562840B CN201610889886.9A CN201610889886A CN106562840B CN 106562840 B CN106562840 B CN 106562840B CN 201610889886 A CN201610889886 A CN 201610889886A CN 106562840 B CN106562840 B CN 106562840B
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implant
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刘翔
吴明明
桂宝珠
陈国明
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Shanghai Minimally Invasive Xintong Medical Technology Co Ltd
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    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
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Abstract

本发明提供一种将植入体装载到输送系统中的导引盖和装载系统，能够简化使用植入体进行介入治疗手术时的操作。该导引盖具有贯通的内腔，并且包括：一锥面；与所述锥面的较小开口端连通的直管或锥管；所述锥面的较大开口端的边缘向外翻开所形成的盖体。本发明的上述装载系统包括一导引器，以及上述导引盖。根据本发明的技术方案，在将植入体装载到输送系统的操作中，导引盖既能使瓣膜假体与输送系统连接件连接，又能够帮助瓣膜假体减小尺寸以完全进入输送系统，整个操作较为简单、快捷，有助于缩短临床手术的时间。

Description

一种将植入体装载到输送系统中的导引盖和装载系统
本申请是申请日为2013年10月31日、发明名称为“一种将植入体装载到输送系统中的装置和方法”的201310534075.3号发明专利申请的分案申请。
技术领域
本发明涉及一种将植入体装载到输送系统中的导引盖和装载系统。
背景技术
心脏瓣膜病是我国最常见的心脏病之一，其中主要为风湿热导致的瓣膜损害；近年来随着人口老龄化的发展，瓣膜退行性变(包括钙化和粘液变性等)以及代谢障碍性瓣膜损害在我国也日益增多。
微创介入治疗方法具有无需开胸，创伤小，患者恢复快等优点。近10年内介入治疗方向显示出内外科能治疗的病例，介入都能治疗；外科手术不能治疗的病例，介入也能治疗。新世纪瓣膜病介入治疗，研究工作明显加速，经皮介入瓣膜植入术，由实验研究发展到小规模临床并行的研究阶段，瓣膜病介入可能突破技术上的“瓶颈”，迅速实现广泛的临床应用，再次成为介入性心脏病学领域的关注焦点。
CN101460115A描述了一种装载介入心脏瓣膜到输送系统的装置，它由一个流入锥体42、流入管38、流出锥体34、流出管40和盖子36组成，通过盖子36将介入心脏瓣膜压入流出锥体34，介入瓣膜的一端被流出锥体34压缩，然后流入管38从盖子36中间的孔穿过，撑开介入瓣膜被压缩缩小的部分到与输送系统导管尺寸相当，使介入瓣膜支架与输送系统连接。操作输送系统及保护导管的流出管将介入瓣膜支架一部分收到输送系统内部，然后打开盖子及退下流出锥体，将介入瓣膜支架的另外一端压入到流入锥体，缩小剩余部分的支架尺寸，操作输送系统将整个介入瓣膜支架收入到输送系统内。这种装置在手术中的操作较为复杂。
发明内容
有鉴于此，本发明提供一种将植入体装载到输送系统中的导引盖和装载系统，能够简化使用植入体进行介入治疗手术时的操作。本发明的其他优点将结合实施例加以说明。
为实现上述目的，根据本发明的一个方面，提供了一种将植入体装载到输送系统中的导引盖。
本发明的将植入体装载到输送系统中的导引盖具有贯通的内腔，并且该导引盖包括：一锥面；与所述锥面的较小开口端连通的直管或锥管；所述锥面的较大开口端的边缘向外翻开所形成的盖体。
可选地，所述内腔包括第一内腔和第二内腔，所述第一内腔位于所述锥面内，第二内腔位于所述直管或锥管内，所述第一内腔为锥形，所述第二内腔为圆柱形或圆锥形。
可选地，所述第二内腔为锥形，且第二内腔的锥度小于第一内腔。
可选地，所述盖体上设置有一个环形凹槽。
可选地，在所述导引盖中，其锥面与所述直管或锥管之间有一过渡段。
可选地，所述植入体为心脏瓣膜支架。
根据本发明的另一方面，提供了一种将植入体装载到输送系统中的装载系统。
本发明的将植入体装载到输送系统中的装载系统包括一导引器，以及本发明中的导引盖，并且：所述导引器具有沿轴向渐缩的圆周表面，该表面的两个边缘分别形成较大和较小的开口端，该较小的开口端的直径大于所述导引盖的锥面的较小的开口端的直径；所述导引盖的尺寸和所述导引器的尺寸使得所述盖体能够盖在所述导引器的较大开口端上，并且此时所述直管或锥管的端部能够通过所述导引器然后从较小的开口端伸出。
可选地，所述盖体具有卡槽；所述导引器的较大开口端的外缘有凸台，当所述导引盖盖在所述导引器上时，所述凸台进入所述卡槽。
可选地，所述导引器具有两段渐缩表面，该两段渐缩表面的边缘各形成较大和较小开口端；第一段渐缩表面的较大开口端为所述导引器的较大开口端；第一段渐缩表面的较小开口端的直径等于或略小于第二段渐缩表面的较大开口端的直径，并且二者互相连接；第二段渐缩表面的较小开口端为所述导引器的较小开口端。
根据本发明的技术方案，在将植入体装载到输送系统的操作中，导引盖既能使瓣膜假体与输送系统连接件连接，又能够帮助瓣膜假体减小尺寸以完全进入输送系统，整个操作较为简单、快捷，有助于缩短临床手术的时间。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。其中：
图1A、图1B和图1C是根据本发明实施例的导引盖的结构的示意图；
图2A和图2B是根据本发明实施例的导引器的优选结构的示意图；
图3A和图3B是根据本发明实施例的收纳管的示意图；
图4是与本发明实施例有关的一种瓣膜假体的示意图；
图5是根据本发明实施例的将植入体装载到导引器的示意图；
图6A和图6B是根据本发明实施例的将导引盖与导引器扣合操作的示意图；
图7是根据本发明实施例的输送系统与瓣膜假体连接的示意图；
图8是根据本发明实施例的打开导引盖与导引器的示意图
图9是根据本发明实施例的利用导引盖进一步缩小瓣膜假体尺寸的示意图；
图10是根据本发明实施例的瓣膜假体被装载到导引盖中的示意图；
图11是根据本发明实施例的瓣膜假体被收入到收纳管中的示意图
图12是根据本发明实施例的瓣膜假体被完全装载到输送系统中的示意图。
具体实施方式
以下结合附图对本发明的示范性实施例做出说明，其中包括本发明实施例的各种细节以助于理解，应当将它们认为仅仅是示范性的。因此，本领域普通技术人员应当认识到，可以对这里描述的实施例做出各种改变和修改，而不会背离本发明的范围和精神。同样，为了清楚和简明，以下的描述中省略了对公知功能和结构的描述。
本实施例中的将植入体装载到输送系统中的装置包括导引盖、导引器、收纳管，以下结合附图分别加以说明。
图1A、图1B和图1C是根据本发明实施例的导引盖的结构的示意图，其中图1A示出了导引盖的外形，图1B示出了导引盖轴向的一个剖面，图1C是导引盖的立体图和立体图的A向视图。如图1A和图1B所示，导引盖1具有一锥面101和与该锥面的较小开口端102连通的直管或锥管103，该锥面的较大开口端104的边缘向外翻开形成开口朝向直管或锥管103的盖体105。盖体105内可以有一圈环形的凹槽13。导引盖1的锥面101与直管或锥管103之间可以有一段过渡弧面15，从而使导引盖1的内表面更加平顺，便于植入体在其中顺利移动。
导引器具有渐缩表面，该渐缩表面是沿导引器轴向渐缩的圆周表面，其边缘各形成导引器的较大开口端和较小开口端，其较小开口端的直径大于直管或锥管103的自由端1031的直径。并且，导引盖的尺寸与导引器的尺寸使得盖体105能够固定地盖在导引器的较大开口端，并且此时自由端1031能够通过导引器然后从较小开口端伸出。
导引器的整体形状可以是圆锥的一部分，然而优选的方式是由互相连接的两段渐缩表面构成，参考图2A和图2B。图2A和图2B是根据本发明实施例的导引器的优选结构的示意图，其中图2B为图2A的A向视图。如图2A和图2B所示，导引器2具有互相连接的两段渐缩表面9和10，它们的边缘各形成导引器的较大开口端8和较小开口端11。在渐缩表面9和10的连接处201，渐缩表面9的开口端的直径略小于渐缩表面10的开口端的直径，也就是说导引器2的中部略为收细，这使得植入体在放入导引器后不会自动弹出，便于植入手术的操作。
导引盖的盖体105可以是通过摩擦力与导引器2的较大开口端固定，也可以是利用图1C与图2B中的卡槽17以及凸台12。卡槽17位于盖体105内，是由多个凸起部171从盖体105的边缘起沿锥面101的径向延伸而形成(参见图1C)，凸台12为多个，位于导引器的较大开口端8的边缘构成的平面，这样，当盖体105盖在导引器的较大开口端8上时凸台12能够进入卡槽17，此时适当旋转盖体105，凸台12就可以被凸起部171阻挡从而使盖体105与导引器2固定。
图3A和图3B是根据本发明实施例的收纳管的示意图，其中图3A示出了收纳管的外形，图3B是收纳管的剖面图。如图3B所示，收纳管3包括直管部5和锥体部7；可选地，二者之间还可以有一段过渡弧面6，使收纳管3的内表面更加平顺。收纳管3也可以由一个或两个锥管构成，此时需要该锥管的顶角相当小。锥体部7的开口端的直径介于导引盖1的锥面101的较小开口端102的直径与导引器2较小开口端11的直径之间。直管部5的自由端可以有一个内倒角或内圆角4，便于与导管的装配。
使用本发明实施例中的上述装置，能够将植入体装载到输送系统，装载操作依次示出图4至图12中，以下结合图4至图12对该装载操作做出说明。
本实施例中的装置可以用来将心脏瓣膜假体等植入体装载到输送系统例如导管。图4是与本发明实施例有关的一种瓣膜假体的示意图。如图4所示，瓣膜假体18具有瓣膜流入端19和瓣膜流出端20，后者的端部有瓣膜挂耳27。
图5是根据本发明实施例的将植入体装载到导引器的示意图。如图5所示，在装载时首先将瓣膜假体18装载到导引器2中(如图中箭头所示)，使瓣膜假体18的瓣膜流出端20从导引器2的较大开口端8进入导引器2并且从较小开口端11露出，此时瓣膜流入端19也露在导引器2的较大开口端8的外部。
图6A和图6B是根据本发明实施例的将导引盖与导引器扣合操作的示意图。如图6A所示，使导引盖1与导引器2沿图中箭头方向相向运动，让导引盖1的直管或锥管103从导引器2的较大开口端8伸入导引器2内的瓣膜假体18内。然后如图6B所示，导引盖1的直管或锥管103的自由端1031从导引器2的较小开口端11露出并将瓣膜假体流出端20撑开(如图中箭头所示)。此时瓣膜流入端19被容纳在导引盖1的盖体105内的凹槽13(图中未示出)中，避免了瓣膜流入端19受力变形。
图7是根据本发明实施例的输送系统与瓣膜假体连接的示意图。如图7所示，先将收纳管3套在输送系统导管26上，然后一起与装载有瓣膜假体的导引器相向运动(如图中箭头所示)，在此过程输送系统导引头24从导引盖1的直管或锥管103的自由端1031进入导引盖1内，挂耳23挂在输送系统连接件25表面的小钩251上(参考图8)。先移动收纳管3使植入体部分进入收纳管，然后移动输送系统导管26将植入体部分包覆到导管内，再移动收纳管3使植入体更多部分进入收纳管，此步骤可重复直至植入体由于其较大的径向支撑力而无法再更多地被包覆到导管及收纳管内为止。如图8所示状态。另外，由于锥体部7的开口端的直径介于锥管103的自由端1031与导引器2的较小开口端11之间，这样，在图7的状态下移动收纳管3，可使其部分地进入导引器2的较小开口端11，使植入体部分进入收纳管，从而其外廓有所收缩，便于接下来将导引器2向图中右方移动，参考图8，图8是根据本发明实施例的打开导引盖与导引器的示意图。如图8中所示，将导引盖1和导引器2打开，并使二者反向移动(如图中两个箭头所示)。
图9是根据本发明实施例的利用导引盖进一步缩小瓣膜假体尺寸的示意图。如图9所示，将导引盖1的盖体105朝向输送系统导引头24并使二者相向运动(如图中箭头所示)，能够使瓣膜流入端19及其附近部分进一步缩小，最终如图10所示，输送系统导引头24从导引盖的直管或锥管103的自由端1031伸出。图10是根据本发明实施例的瓣膜假体被装载到导引盖中的示意图。
在图10所示的状态下，令收纳管3沿图中箭头方向运动并保持输送系统导管26不动，就可使导引盖1被收纳管顶掉，同时瓣膜假体18被收入到收纳管3中，呈图11所示状态，图11是根据本发明实施例的瓣膜假体被收入到收纳管中的示意图。
如图11所示，此时沿图中箭头所示方向推动输送系统导管26使得输送系统连接件25及其与输送系统导引头之间的瓣膜假体一起进入输送系统导管26中，此时如图12所示，瓣膜假体18被完全装载到输送系统中，图12是根据本发明实施例的瓣膜假体被完全装载到输送系统中的示意图。在图11或图12的状态下可从收纳管3的锥体部7的开口端取下导引器2。
从以上的将植入体装载到输送系统的操作可以看出，导引盖既能使瓣膜假体与输送系统连接件连接，又能够帮助瓣膜假体减小尺寸以完全进入输送系统，整个操作较为简单、快捷，有助于缩短临床手术的时间。从本实施例的装置的结构来看，仅用3个部件即可完成瓣膜的装载，各个部件外形特点分明，不会造成混淆；导引器的中部略为收细，能够使瓣膜假体放入其中不会自动弹出和引起操作不便；收纳管一端有一较长锥面和直管部或全部为锥管，既可以保护输送系统导管，而锥面设计可以将管件的开口做的更大，因此能够适应更多不同形状设计的瓣膜假体，保护瓣膜假体不受到损伤，装载容易。以上这些都有助于临床手术的顺利操作。
上述具体实施方式，并不构成对本发明保护范围的限制。本领域技术人员应该明白的是，取决于设计要求和其他因素，可以发生各种各样的修改、组合、子组合和替代。任何在本发明的精神和原则之内所作的修改、等同替换和改进等，均应包含在本发明保护范围之内。

Claims (9)

1.一种将植入体装载到输送系统中的导引盖，其特征在于，该导引盖具有贯通的内腔，并且该导引盖包括：
一锥面；
与所述锥面的较小开口端连通的直管或锥管；
所述锥面的较大开口端的边缘向外翻开所形成的盖体。
2.根据权利要求1所述的导引盖，其特征在于，所述内腔包括第一内腔和第二内腔，所述第一内腔位于所述锥面内，第二内腔位于所述直管或锥管内，所述第一内腔为锥形，所述第二内腔为圆柱形或圆锥形。
3.根据权利要求2所述的导引盖，其特征在于，所述第二内腔为锥形，且第二内腔的锥度小于第一内腔。
4.根据权利要求1所述的导引盖，其特征在于，所述盖体上设置有一个环形凹槽。
5.根据权利要求1所述的导引盖，其特征在于，所述锥面与所述直管或锥管之间有一过渡段。
6.根据权利要求1至5中任一项所述的导引盖，其特征在于，所述植入体为心脏瓣膜支架。
7.一种将植入体装载到输送系统中的装载系统，其特征在于，包括一导引器，以及权利要求1至6中任一项所述的导引盖，并且：
所述导引器具有沿轴向渐缩的圆周表面，该表面的两个边缘分别形成较大和较小的开口端，该较小的开口端的直径大于所述导引盖的锥面的较小的开口端的直径；所述导引盖的尺寸和所述导引器的尺寸使得所述盖体能够盖在所述导引器的较大开口端上，并且此时所述直管或锥管的端部能够通过所述导引器然后从较小的开口端伸出。
8.根据权利要求7所述的装载系统，其特征在于，所述盖体具有卡槽；所述导引器的较大开口端的外缘有凸台，当所述导引盖盖在所述导引器上时，所述凸台进入所述卡槽。
9.根据权利要求7或8所述的装载系统，其特征在于，所述导引器具有两段渐缩表面，该两段渐缩表面的边缘各形成较大和较小开口端；第一段渐缩表面的较大开口端为所述导引器的较大开口端；第一段渐缩表面的较小开口端的直径等于或略小于第二段渐缩表面的较大开口端的直径，并且二者互相连接；第二段渐缩表面的较小开口端为所述导引器的较小开口端。
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