CN1338951A - 用于血管内心脏瓣膜手术的装置 - Google Patents

用于血管内心脏瓣膜手术的装置 Download PDF

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CN1338951A
CN1338951A CN00803476A CN00803476A CN1338951A CN 1338951 A CN1338951 A CN 1338951A CN 00803476 A CN00803476 A CN 00803476A CN 00803476 A CN00803476 A CN 00803476A CN 1338951 A CN1338951 A CN 1338951A
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cardiac valve
pump
valve
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expansion piece
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托斯滕·西斯
威廉·弗拉芒
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Abiomed Europe GmbH
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Impella Cardiotechnik AG
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—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
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    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
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    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—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
    • 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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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/894—Passive valves, i.e. valves actuated by the blood
    • A61M60/896—Passive valves, i.e. valves actuated by the blood having flexible or resilient parts, e.g. flap valves

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Abstract

本发明涉及一种治疗心脏瓣膜闭锁不完全或心脏瓣膜狭窄的装置,它包括一个微型轴流泵40。所述微型轴流泵的泵部分14包括可一个用来推开狭窄瓣膜的膨胀件18。膨胀件为一个高压气囊。在膨胀之中,微型轴流泵40以这种方式工作使得其辅助心脏瓣膜。在心脏瓣膜闭锁不完全的情况下,包围柔性心脏瓣膜生物替代物20的固定模21固定到膨胀件17上。通过膨胀,固定模21被压紧到闭锁不完全的心脏瓣膜上,结果心脏瓣膜停止工作,并且心脏瓣膜生物替代物的瓣膜展开并代替天然心脏瓣膜的功能。

Description

用于血管内心脏瓣膜手术的装置
本发明涉及一种用于血管内的心脏瓣膜手术的装置，本装置包括一个固定在导管上的微型轴流泵。
在专利WO98/43688种，描述了一种心内血液泵，它包括马达部分和泵部分，并可以通过血管系统引导到心脏中。这种血液泵可以经由主动脉布置在主动脉瓣膜位置，例如，用于从左心室向主动脉泵送血液。这种血液泵适合支持或者代替心脏的泵送功能。它们可以不必打开心脏而将其布置在心脏内。
根据专利WO97/37697，知道一种血管内的血液泵，它也包括马达部分和泵部分，并与导管连接。可以通过病人的血管系统推送该血液泵进入。这是一个最大直径大约7mm的微型轴流泵。泵部分被一个膨胀阻塞件围绕，来阻塞在泵壳体外面的流动路径。这样，确保吸入的血液通过马达部分在流动方向输送，并避免了在泵部分周围流动造成的短路。阻塞件可以是固定到泵壳体上的环形气囊或者是与泵壳体连接的吸入软管。血液泵在血管内使用，阻塞件只是为了阻塞围绕泵部分的血管腔，但不引起血管壁变形。因此，阻塞件气囊是一个以低压力膨胀的低压气囊，从而以非创伤方式密封到血管壁上。
还公知具有气囊的膨胀导管，利用它可通过推开瓣膜狭窄部分而消除瓣膜狭窄。这种膨胀导管也可以嵌入一个环形固定模(stent)中，该固定模包括一个可膨胀的金属结构并构成支承件，从而形成瓣膜狭窄部的永久扩展支承件。这种膨胀导管设计为灌流导管，它具有用来通过膨胀气囊输送血液的泵部分。对于心脏瓣膜手术，如果其具有仅最大2mm的小直径，那么这种膨胀导管就不合适了。
心脏瓣膜最常见的缺陷是瓣膜闭锁不全和瓣膜狭窄。在瓣膜闭锁不全的情况下，瓣膜不能充分关闭。这造成血液回流。通常，这种瓣膜要利用人工瓣膜替代。狭窄瓣膜具有与边缘长在一起的瓣膜小叶，从而瓣膜不能完全打开，不容许血液通过其进行充分流动。
对心脏瓣膜有两种形式的手术：在心脏瓣膜替换中，通过手术除掉天然心脏瓣膜，并用生物替代物或者机械心脏瓣膜来代替。对这种手术，必须保证手术区无血，即改变血液的自然流动。在修复天然心脏瓣膜的过程中，使用一个气囊导入到瓣膜可进行最低侵入的介入治疗。这类手术，例如在主动脉瓣膜位置，心脏外科医生或者心脏病学家需要很高的技术。尤其是其原因在于，在间断过程中必须阻挡通过主动脉的血液流动，从而为了恢复血管系统供血而必须在很短的时间内进行手术。并且，阻挡主动脉血液流动时，通过冠状动脉供血被阻止，心脏内血液压力急剧升高。
本发明的目的是提供一种用于血管内的心脏瓣膜手术的装置，利用它可以相对简单和不受时间约束地进行最小侵入的瓣膜手术。
按照本发明，通过权利要求1所述的特征来实现该目的。
在本装置中，提供一个血管内微型轴流泵，即本泵可通过病人的血管系统推进去，并具有对应的不超过8mm的小外径。微型轴流泵的泵部分具有一个膨胀件，如果将之放置在心脏瓣膜，那么适合打破心脏瓣膜狭窄部。膨胀件优选包括一个高压气囊，其膨胀直径至少15mm，并利用至少1bar的压力膨胀。高压气囊布置在心脏瓣膜内并利用液体进行膨胀，以便打破或吹开瓣膜狭窄部。这样，膨胀件形成打破瓣膜狭窄部的激活件，特别是在主动脉瓣膜狭窄部和二尖瓣狭窄的情况下更是如此。
泵部分或者邻接泵部分的管的间隙至少8mm，从而避免太强的、生理流量高达71/min的局部血液流。并且膨胀件的载体应该具有至少8mm的外径，以便形成对膨胀件足够大的支承并且直径增加程度不过分。
并且，本发明涉及一个按照权利要求5所述的、用于在血管内放置心脏瓣膜替代物的装置。本装置也具有支承膨胀件的微型轴流泵。而且，提供一个在其内侧承载柔性心脏瓣膜替代物的固定模。包含心脏瓣膜替代物的固定模可以被引入到致病的心脏瓣膜中，并可以被膨胀件所撑胀，以便它压迫天然心脏瓣膜小叶分开。心脏瓣膜替代物包括自动起作用的并代替天然心脏瓣膜的单叶或多叶心脏瓣膜。
作为心脏瓣膜替代物，可以使用小牛或母牛的颈静脉瓣。这是天然组织的瓣膜生物替代物。
下面参照附图详细说明本发明的实施例。这些附图包括：
图1表示引入到主动脉瓣中的用来消除瓣膜狭窄部的装置；
图2表示图1的装置，其中膨胀件处于膨胀状态；
图3表示柔性心脏瓣膜替代物的纵截面；
图4表示具有膨胀固定模的图3的心脏瓣膜替代物；
图5是一个截面图，表示具有环绕气囊的泵部分以及合拢的、其中包含心脏瓣膜替代物的固定模；
图6是一个用来移植柔性心脏瓣膜替代物的装置；以及
图7表示心脏的某区域，其中移植的心脏瓣膜替代物位于主动脉位置。
图1表示心脏的一部分，称为左心室LV，血液从这里经过主动脉瓣膜流入到主动脉AO。主动脉瓣膜具有三个瓣膜小叶，它们伸入到主动脉AO中并形成流体意义上的单向阀，仅容许流向主动脉。
为推开具有狭窄部的主动脉瓣膜AK，示于图1的装置经过主动脉引入到心脏中。本装置包括一个和微型轴流泵40连接的导管10。泵包括驱动部分11，后者包含电动马达并驱动从圆柱状驱动部分11末端延伸出来的轴12。支承腹板13沿轴向从驱动部分11延伸管状泵部分14。泵部分14包括一个具有由驱动轴12驱动的叶轮的泵环15，以及一个轴向延伸泵环15的套管16。整个泵装置，即驱动部分11和泵部分14，具有8mm的最大直径。导管10包括用来为微型轴流泵40供电和进行控制的电线，以及一个通过其供给压力液体的压力腔。
在泵部分14上具有一个环形气囊17，以合拢状态示于图1。通过导管10的压力腔，可以利用液体来膨胀气囊17。本气囊是具有至少15mm膨胀直径的高压气囊，优选膨胀直径在15到40mm之间，可以抗压达8bar。气囊17延伸超过套管16长度的一部分。其整个长度可以由刚性环支承，从而防止套管16受到压缩。
为了将泵装置引导到主动脉内，首先是在主动脉和左心室内放置一个引导线(没示出)。然后，该装置沿着引导线前进并定位在主动脉瓣膜AK处，结果出口部分19在主动脉内，进口部分16a在左心室LV内。这样，泵部分15被主动脉瓣膜AK包围。本泵装置向回输送血液，即它在出口部分19轴向抽取和横向喷送血液。
当泵装置布置在图1所示的位置后，启动驱动部分11以便该泵从左心室LV向主动脉AO输送血液。这样，心脏的体积和压力降低并平静下来。然后，形成膨胀件18的气囊17膨胀并在主动脉瓣膜AK中间扩张。利用高压膨胀气囊17，主动脉瓣膜AK的瓣膜小叶被推开，它们和接缝处可能的粘连被打破。以这种方式，狭窄瓣膜被推开足够大以重新恢复为完全打开状态。利用本泵装置，可以在平静环境下进行这种形式的瓣膜手术，不必匆忙。因为在手术过程中，利用泵装置通过膨胀件输送心脏输出的血液(l/min)。上述膨胀件可以按照类似的方式用于打开具有狭窄缺陷的二尖瓣膜。
图3到图7涉及这样的装置，它用瓣膜替代物来替换闭锁不完全的瓣膜。为此目的，一般使用与图1和图2所述相同的装置。本装置示于图6。一个柔性心脏瓣膜替代物20位于减压的与合拢的膨胀件18上，在心脏瓣膜替代物20上方是一个可压缩的螺旋形固定模21。
图6还示出引导线22，用来推进具有导管10的本装置并将其布置在正确的位置。引导线从套管16的末端伸出来。引导线穿过套管中的横向孔23并在泵部分14和驱动部分11外面沿着导管10延伸。
柔性心脏瓣膜替代物20示于图3。它是取自母牛或小牛的修复替代物。为此目的，取下包括血管瓣膜25的血管的一部分24。瓣膜24可以为单叶或三叶瓣膜。按照图4，这个瓣膜替代物20布置在固定模21内。固定模21是金属杆式的管状件，在本实施例中为弯曲的曲折线状，并容许轴向压缩或径向膨胀。也可以使用其它固定模结构，例如可伸展材料制造的单元结构。重要的是，该固定模可以可靠地保持压缩管状形状和膨胀管状形状。心脏瓣膜替代物20的软管状的壁24缝合到固定模21的杆上。心脏瓣膜替代物20固定在固定模21的内侧，以便心脏瓣膜替代物移植后，固定模静止于天然心脏瓣膜和心脏瓣膜生物替代物之间。这样，固定模不需要使用针对血栓形成的抗凝血药。
图5表示具有泵环15的泵部分14。膨胀件18的气囊和心脏瓣膜替代物20合拢为围绕泵环15的几个环，其中心脏瓣膜替代物固定在固定模21的杆上。在此状态下，气囊、心脏瓣膜替代物20和固定模21形成围绕泵部分14的平整包裹物。该包裹物位于天然心脏瓣膜AK中。随后启动泵，膨胀件17随着泵工作而膨胀。固定模21被胀大，胀宽心脏瓣膜替代物24，并向外压迫天然心脏瓣膜AK的瓣膜小叶至打开位置(如图7所示，收缩期瓣膜的位置)。这样，主动脉瓣膜AK被钝化。固定模21保留在心脏瓣膜开口内。在固定模中，存在扩大到其原始位置并包括瓣膜小叶25的心脏瓣膜替代物24。这个心脏瓣膜替代物现在执行天然主动脉瓣膜AK的功能。
为避免心脏瓣膜替代物移动，固定模21或心脏瓣膜替代物20可以固定到围绕天然心脏瓣膜的环26内。这是一个软骨制成的坚固环，用作心脏瓣膜替代物的支承件。

Claims (7)

1.一种用于血管内的心脏瓣膜手术的装置，其特征在于，该装置包括一个固定在导管(10)上并具有管状泵部分(14)的微型轴流泵(40)，以及一个围绕泵部分(14)的膨胀件(18)；该膨胀件当位于所述心脏瓣膜(AK)内时，适合打破所述心脏瓣膜的狭窄部。
2.如权利要求1所述的装置，其特征在于，所述膨胀件(18)包括一个环形高压气囊，它利用至少1bar的压力进行膨胀。
3.如权利要求1或2所述的装置，其特征在于，所述泵部分(14)包括一个泵环(15)和一个与之连接的管状套管(16)。
4.如权利要求1到3中任何一项所述的装置，其特征在于，所述高压气囊位于一个刚性的环状支承件上。
5.一种用于血管内的心脏瓣膜手术的装置，其特征在于，该装置包括一个固定在导管(10)上并具有管状泵部分(14)的微型轴流泵(40)；一个用来胀大固定模(21)的膨胀件(18)；以及一个承载合拢的柔性心脏瓣膜替代物(20)并适于被膨胀件(17)胀大的固定模(21)。
6.如权利要求5所述的装置，其特征在于，所述心脏瓣膜替代物(20)被缝合到固定模(21)上。
7.如权利要求5或6所述的装置，其特征在于，所述心脏瓣膜替代物(20)具有软管状的壁(24)，它与膨胀件(17)的气囊壁合拢在一起。
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