CN1359279A - 治疗二尖瓣关闭不全的装置和方法 - Google Patents

治疗二尖瓣关闭不全的装置和方法 Download PDF

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CN1359279A
CN1359279A CN00809730A CN00809730A CN1359279A CN 1359279 A CN1359279 A CN 1359279A CN 00809730 A CN00809730 A CN 00809730A CN 00809730 A CN00809730 A CN 00809730A CN 1359279 A CN1359279 A CN 1359279A
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詹·奥托·索里姆
佩尔·奥拉·基姆布拉德
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2451—Inserts in the coronary sinus for correcting the valve shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/902—Method of implanting
    • Y10S623/903—Blood vessel

Abstract

一种用于治疗二尖瓣环带扩张的装置,包括一细长体(8),该细长体有两种状态。在第一种状态,该细长体(8)可插入冠状窦(5)中并且其形状与冠状窦(5)的形状相适应。而当该细长体(8)位于冠状窦(5)内时,该细长体(8)可转变成有减小曲率半径的第二种状态,因此使冠状窦(5)的曲率半径减小,同时使二尖瓣环带(6)的周缘以及曲率半径减小。

Description

治疗二尖瓣关闭不全的装置和方法
本发明总体上涉及用于治疗二尖瓣关闭不全的装置和方法，尤其是用于治疗二尖瓣环带扩张的装置和方法。
二尖瓣关闭不全可能有多种原因，例如缺血性疾病、二尖瓣器官的变性疾病、风湿热、心内膜炎、先天性心脏病和心肌病。二尖瓣的四个主要结构部分是环带、两个小叶、索带(chordae)和乳头肌。其中的任意一个或各种不同的组合都可能受到损害并产生关闭不全。不管病因如何，二尖瓣关闭不全在病理上的主要表现是环状扩张。而且，很多二尖瓣关闭不全的病人主要或仅由于后面的环状扩张，前面的小叶的环带不会扩张，因为它固定在心脏基部的纤维架上。
对二尖瓣关闭不全的自然史的研究发现，具有严重二尖瓣关闭不全但完全无病症的病人通常在五年内发展到严重伤病。目前，治疗包括二尖瓣替换或修复，两种方法都需要作打开心脏的外科手术。替换能够用机械瓣(valve)或生物瓣进行。
机械瓣带来血栓栓堵的危险，并需要抗凝血剂，这些有潜在的危害，而生物假体又有使用寿命的限制。进行替换的另一危害是有心内膜炎的危险。而对于瓣的修复，这些危险和其它瓣的相关并发症大大减少。
当存在基本正常的前小叶时，理论上能够修复二尖瓣。修复的四个基本方法包括：使用瓣环成形环、分段切除病变的后小叶的四角部分、缩短细长的索带和将后小叶索带移位到前小叶。
瓣环成形环用于能长期减小环状扩张。所有常见的环都是沿在左心房中的二尖瓣环带附近的二尖瓣后小叶来缝合。Duran环完全环绕该瓣，而其它的环都朝着前小叶开口。该环既可以是刚性的，就象最初的Carpentier环，或者是柔性的但却没有弹性，就象Duran环或Cosgrove-Edwards环。
目前对二尖瓣关闭不全的有效治疗需要通过使用总心肺分流术、主动脉横向夹和心脏麻痹抑制术来进行打开心脏的外科手术。
对于某些病人，这尤其危险。老年病人以及左心室功能弱、有肾病、主动脉严重钙化、先前做过心脏手术或有其它伴发病的病人尤其可能从很小侵入的方法中受益，尽管修复并不完全。目前的趋势是朝着在没有心肺分流的情况下进行更小侵入的冠状动脉手术，同时，PTCA也需要发展一种很小侵入的方法，用于修复通常伴发的二尖瓣关闭不全。
因此，本发明的第一目的是提供一种在不需要心肺分流和打开胸腔和心脏的情况下治疗二尖瓣关闭不全的装置和方法。
本发明的第二目的是用更小侵入的手术来减小二尖瓣环带。
这些和其它目的通过如附后的权利要求1所限定的装置和如附后的权利要求7所限定的方法来实现。
根据本发明，一种用于治疗二尖瓣关闭不全的装置包括一细长体，该细长体的大小能插入冠状窦并有两种状态，在第一种状态，该细长体的形状与冠状窦的形状相适应，而当该细长体位于冠状窦内时，该细长体可从所述第一状态转变成有减小的曲率半径的第二种状态，因此使冠状窦的曲率半径减小，同时使二尖瓣环带的周缘减小。
优选是，提供有通过弯曲和/或缩短该细长体而将该细长体转变成第二状态的装置，从而使该细长体从较大的曲率半径变成较小的曲率半径。
优选是，该转变装置可以包括通过细长体的非对称收缩而使该细长体弯曲和/或缩短的装置。
而且，该细长体可以包括一个记忆材料，以便能向第二状态转变。
在优选实施例中，细长体可以有一支承体部分(stent)。在一个可选实施例中，本发明的装置可以包括几个支承体部分，所述弯曲和/或缩短的装置包括用于缩短该支承体部分之间的距离的丝线。
根据第二方面，一种减小二尖瓣环带的周缘的方法，包括以下步骤：将细长体插入在二尖瓣的后小叶附近的冠状窦；然后，当细长体定位在冠状窦中时，使该细长体弯曲和/或缩短，以便减小冠状窦的曲率半径，从而减小二尖瓣环带的周缘。
因此，本发明利用了冠状窦的位置靠近二尖瓣环带的优点。从而通过采用目前的导管引导技术就可以进行修复。
冠状静脉将血液从心肌排向右心房。较小的静脉将血液直接排向心房腔内，较大的静脉将伴随主动脉并伸入基本环绕二尖瓣孔和环带的冠状窦中。该较大的静脉在进入在心房间隔和后Eustachian窦之间的右心房之前在后房室槽内延伸，并位于在左心房壁和心室心肌之间的脂肪组织内。
对于成年人，冠状窦的过程(course)可以离二尖瓣后小叶的中间固定部分(attachment)5-15mm。在对正常体重的成年人的尸检中所进行的初步测量显示了类似的结果，在中间固定部分处的距离为5.3±0.6mm，在后小叶侧面的距离为大约10mm。冠状窦的周缘在其口处为18.3±2.9mm(假设后小叶的直径为5.8±0.9mm)，沿后小叶的外侧为9.7±0.6mm(对应于直径3.1±0.2mm)。
通过下面参考附图对优选实施例的说明，可以更好地理解本发明，附图中：
图1是心脏部分的剖视图；
图2和3是本发明第一实施例的装置的示意图；
图4-6是表示可以在使图2和3中的装置在冠状窦中定位时使用的器械的示意图；
图7是图2中所示的第一实施例的局部放大图；
图8和9是表示图2和3中的装置在冠状窦中的定位的示意图；
图10和11是表示本发明第二实施例的装置在冠状窦中的定位的示意图；以及
图12和13是表示本发明第三实施例的装置在冠状窦中的定位的示意图。
图1是穿过后心房和心室的槽1的心脏区域的横剖图，该区域充满脂肪组织。图中还表示了二尖瓣的后小叶2以及前房心肌与心室心肌的连接部分3、4。如图所示，冠状窦5靠近二尖瓣环带6并在后小叶2的固定部分7的后面。因为冠状窦5基本环绕二尖瓣环带6，因此，弯曲的冠状窦5的曲率半径的减小也导致二尖瓣环带6的直径和周长的减小。
图2的装置包括一个细长体8，该细长体8由记忆金属例如镍钛合金或者其它类似材料制成，该类似材料对初始形状有记忆，如图3所示的初始形状，并能暂时压迫成另外的形状，如图2所示。该细长体8包括一个、两个或多个成螺旋形或其他形状的记忆金属线9，以便结合在一起并能进行如下方式的运动。沿细长体8固定有多个挂钩10，这些挂钩10从该细长体径向向外伸出。这些挂钩10由图2中的盖板(cover sheet)11覆盖。
通过稳定器12使细长体8成拉伸或伸长状态，如图4所示。该器械12在杆15的远端14有两个臂13，在杆15的近端有锁定装置16。杆15的端头之间的距离等于细长体8在插入冠状窦5中时的合适长度。
臂13能够在如图4所示位置和如图6所示与杆15成一直线的位置之间自由运动。该锁定装置16有两个锁定按钮17，该锁定按钮17通过两弹簧片18从该杆15径向向外压。因此，该细长体8可以推到该稳定器12的杆15上，然后在臂13和按钮17之间伸长，并最终以伸长状态锁定在在臂13和按钮17之间的稳定器12上和按钮17之间，如图5所示。
杆15可以是金属丝，该金属丝在远端14和锁定装置16之间相对较硬，但还是可以弯曲，这样，它将遵循冠状窦5的形状。在靠近锁定装置16处，稳定器12的金属丝更柔软，以便能遵循纹理的弯曲形状。
上述细长体8以如下方式定位在冠状窦5内：
可以通过使用合成材料的引入薄板(sheet)(未示出)来到达静脉系统的入口。进入静脉系统入口后，较长的金属引导丝(未示出)通过该引入薄板前进，并通过该静脉系统进入冠状窦5。该引导丝有X射线距离标志，这样，可以检测引导丝在冠状窦5中的位置。
如图5所示，细长体8锁定在稳定器12上，并引入合成材料的较长盖板11内。然后，通过引入薄板和静脉系统将集料(aggregate)推入在引导丝上的冠状窦5中。当细长体8在冠状窦5中准确定位后，如图8所示，二尖瓣19有一中心间隙20，将盖板11抽出并暴露在冠状窦5内的细长体8。该操作使得细长体8上的挂钩10钩入冠状窦5的壁中和钩入心脏内。细长体8还锁定在稳定器12上，这样，在细长体8处于拉伸或伸长的状态下，该挂钩10与冠状窦5的壁面啮合。
如图6所示，导管21向前推入到引导丝和杆15上，以便通过向着杆15按压弹簧片18而将细长体8从锁定装置16上释放。该运动松开按钮17以及臂13与细长体8的配合，该细长体8收缩，如图9所示，导致弯向二尖瓣环带6，使得该二尖瓣环带6的后面部分向前运动(如图9中箭头所示)。该运动减小了二尖瓣环带6的周缘，从而使中心间隙20关闭。
图7表示沿细长体8的周围部分的金属丝9和挂钩10的局部结构，因此，当至少部分挂钩10的互联部分22缩短至初始形状时，细长体8将进行非对称的收缩，导致该细长体8弯曲。
图10和11表示了细长体8’的一种可选实施例，该细长体8’是成开口U形环形状的单股线，当该成开口U形环形状的单股线插入冠状窦5中时，它与冠状窦5的最靠近二尖瓣环带6的壁面配合。该细长体8’由记忆金属材料构成，当该记忆金属材料返回其初始形状时，将如图11所示弯曲。开口环8’返回其初始形状可以以多种方式开始，这对本领域技术人员是显而易见的。
细长体8″的第三实施例如图12和13所示，包括三个支承体部分23-25，这三个支承体部分分别位于细长体8″一端、中间部分和另一端。这些支承体部分23-25可以如图所示以普通方法定位在冠状窦5内，这样，它们的位置将固定。它们通过丝线26、27连接，这可以从静脉系统的外部操纵，这样相邻支承体部分23、24和24、25之间的距离将缩短。尤其是，该距离的缩短是非对称的，即越在冠状窦5的侧面将越靠近二尖瓣环带6的后面部分。因此，细长体8″弯曲，如图13所示，并使冠状窦5压在二尖瓣环带6上，从而使间隙20关闭。
因此，本发明提供了一种置于冠状窦内的装置，该装置设计成减少二尖瓣环带的扩张。该装置在离后小叶的固定部分一定距离处，该距离不超过目前通过开刀的外科手术而放置的瓣环成形环的距离，而冠状窦在其整个过程(course)上都足够大，以便保持该装置。该装置可以通过导管法或其它任意合适的技术定位，并提供了一种相对于目前的开刀手术法更安全的可选方法。该装置可以设计成或避免在冠状窦中形成血栓，从而减少对阿斯匹林、ticlopedine或抗凝血治疗的需求。
应当知道，在不脱离本发明的精神和范围的情况下，本领域技术人员可以对上述装置和方法进行变化。

Claims (10)

1.一种用于治疗二尖瓣环带扩张的装置，包括一细长体(8；8’；8″)，该细长体的大小能插入冠状窦(5)并有两种状态，在第一种状态，该细长体(8；8’；8″)的形状与冠状窦(5)的形状相适应，而当该细长体(8；8’；8″)位于冠状窦(5)内时，该细长体(8；8’；8″)可从所述第一状态转变成有减小曲率半径的第二种状态，因此使冠状窦(5)的曲率半径减小，同时使二尖瓣环带(6)的周缘减小。
2.根据权利要求1所述的装置，还包括：通过弯曲和缩短该细长体而将该细长体(8；8″)转变成第二状态的装置(9；22；26；27)，从而使该细长体从较大的曲率半径变成较小的曲率半径。
3.根据权利要求2所述的装置，其中：所示转变装置(9；22；26；27)包括通过细长体的收缩而使该细长体(8)弯曲和缩短的装置。
4.根据权利要求1所述的装置，其中：该细长体(8；8’)包括一个记忆材料，以便能向第二状态转变。
5.根据权利要求1或2所述的装置，其中：该细长体(8)包括一个支承体部分。
6.根据权利要求2所述的装置，其中：该细长体(8″)包括几个支承体部分(23-25)，所述弯曲装置(9；22；26；27)包括用于缩短该支承体部分之间的距离的丝线(26、27)。
7.一种减小二尖瓣环带的周缘的方法，包括：将细长体(8；8’；8″)插入在二尖瓣的后小叶(2)附近的冠状窦(5)内；当该细长体定位在冠状窦(5)中时，使该细长体(8；8’；8″)弯曲和缩短，以便减小冠状窦(5)的曲率半径，从而减小二尖瓣环带(6)的周缘。
8.根据权利要求7所述的方法，其中：该细长体(8；8″)的弯曲和缩短是通过使该细长体收缩而进行的。
9.根据权利要求7或8所述的方法，其中：在细长体(8’)内采用记忆材料，以便向第二状态转变。
10.根据权利要求7或8所述的方法，其中：该细长体(8″)由几个支承体部分(23-25)组成，丝线(26、27)用于缩短该支承体部分(23-25)之间的距离，以便使该细长体(8″)弯曲。
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