CN101204337A - 内瓣膜 - Google Patents

内瓣膜 Download PDF

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CN101204337A
CN101204337A CNA2007101948707A CN200710194870A CN101204337A CN 101204337 A CN101204337 A CN 101204337A CN A2007101948707 A CNA2007101948707 A CN A2007101948707A CN 200710194870 A CN200710194870 A CN 200710194870A CN 101204337 A CN101204337 A CN 101204337A
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valve
interior
prosthese
connecting part
intermediate connecting
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CN101204337B (zh
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M·斯帝瑞克
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Bei Lusiyiyao
Cormove SAS
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Laboratoires Perouse SAS
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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
    • A61F2/2412—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
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • 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
    • A61F2230/0073—Quadric-shaped
    • A61F2230/0078—Quadric-shaped hyperboloidal

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明提供一类包括可在收缩状态与扩张状态之间伸展的内假体(12)的内瓣膜(10)。所述内假体(12)形成一个内部管(26)。所述内瓣膜(10)包括位于内部管(26)中的瓣膜(14)，所述瓣膜(14)可在关闭构型和开放构型之间移动，当瓣膜处于关闭构型时可使所述内部管(26)关闭，当瓣膜处于开放构型时可使所述内部管(26)开放。所述内瓣膜(10)具有瓣膜(14)和内假体(12)之间的连接装置(16)。所述连接装置(16)包括至少一个与内假体(12)相连接的中间连接部件(50，52)，所述中间连接部件包括至少一个能相对于内假体(12)移动的区域。所述瓣膜(14)紧固在可移动区域(56)上。

Description

内瓣膜
技术领域
本发明涉及一类内瓣膜，这类内瓣膜包括：
—一个可在收缩状态和扩张状态之间伸展的内假体，所述内假体形成了一个内部管；
—一个置于内部管中的瓣膜，所述瓣膜可在关闭构型和开放构型之间移动，当瓣膜处于关闭构型时可使所述内部管关闭，当瓣膜处于开放构型时可使所述内部管开放；以及
—瓣膜和内假体之间的连接装置。
特别地，这类内瓣膜用于替代人类心脏中的有缺陷的天然瓣膜。
背景技术
已知有一种上述类型的内瓣膜，所述内瓣膜可通过管腔内方法植入以替代天然瓣膜。为此，可通过例如导管将处于收缩状态的内瓣膜放置到其植入位置。然后该内瓣膜可面对需要被替代的天然瓣膜伸展，并压紧天然瓣膜周围的血管壁。
为保证内瓣膜所携带的瓣膜正常工作，必须使瓣膜能牢固地固定在紧贴血管壁的内假体上。
因此，已知方法是将瓣膜缝合在内假体上，以便将瓣膜牢固地固定在构成内假体的可伸展网格的细丝上。所述缝合过程在人体外进行，此时内假体处于其扩张状态和均一的构型。
然而，当内假体被植入以后，其形状会根据所植入患者体内的形状而变化。因此，当天然瓣膜的构型中不存在圆柱形切面时，处于伸展状态的内假体就会成为椭圆形甚至是三角形。而这类径向上不均匀的形状会在固定在网格上的瓣膜处产生应力，从而有可能损坏瓣膜或妨碍瓣膜的正常工作。
发明内容
因此，本发明的一个目的是提供这样一类内瓣膜：它能够适于植入至具有各种体内形状的患者体内，而不会影响其工作的可靠性。
为实现上述目的，本发明提供了一种上述类型的内瓣膜，其特征在于所述连接装置包括至少一个与内假体相连接的中间连接部件，所述中间连接部件包括至少一个能相对于内假体移动的区域，所述瓣膜固定在所述可移动区域上或固定在至少一个可移动区域上。
根据本发明的内瓣膜可包括一个或多个下述特征，这些特征可以独立地或以任何技术上可行的组合方式存在：
—所述内假体包括侧壁，所述侧壁形成至少一个开到内部管的横向开口，该横向开口通过侧壁开到内假体的外部，所述内假体还包括由中间连接部件和固定在所述横向开口上的瓣膜形成的组件；
—由瓣膜和中间连接部件形成的组件可以相对于所述侧壁在由所述横向开口确定的一个行程的范围内局部移动；
—所述中间连接部件具有位于内假体外部的外部区域，和通过内假体的横向开口连接所述或每一个可移动区域的中间区域；
—中间连接部件可沿着其全长相对于内假体局部移动；
—所述中间连接部件置于内假体外部，所述瓣膜沿着紧固线通过在内假体中形成的至少一个横向开口固定在所述中间连接部件上；
—所述中间连接部件的形状基本上与紧固线的形状互补；
—所述中间连接部件为细丝结；
—所述中间连接部件为带状结构；以及
—所述中间连接部件为环绕内假体的管状套。
附图说明
通过阅读下文的仅以示例性方式给出的描述并参考附图，可以更好的理解本发明，附图中：
—图1为本发明的第一种内瓣膜的主视图；
—图2显示的是图1的内瓣膜的水平切面平面II的切面图；
—图3为显示本发明的第二种内瓣膜的与图1视角相同的视图；
—图4为显示本发明的第二种内瓣膜的与图2视角相同的视图；
—图5显示的是用于本发明的第二种内瓣膜的中间固定带状部件的两个实施例；
—图6为显示本发明的第三种内瓣膜的与图1视角相同的视图；
—图7为显示本发明的第三种内瓣膜的与图2视角相同的视图。
具体实施方式
图1和图2显示了本发明的第一种内瓣膜10，用于通过管腔内方法植入而替代有缺陷的天然心脏瓣膜。
内瓣膜10包括管状内假体12、置于管状内假体12中的瓣膜14和内假体12和瓣膜14之间的中间连接装置16。
管状内假体12由具有弹簧性质的管状网格18构成的框架形成。网格18由至少一种不锈钢、形状记忆合金或聚合物的细丝编制而成。在一个变化方案中，用激光从一个管子上切下所述网格。
网格18包括多个细丝区段20，所述细丝区段20彼此相交形成菱形的横向开口22。
网格18具有内表面24和外表面28，所述内表面24形成供血流通过的内部管26，所述外表面28可以压紧血管壁并面对有缺陷的天然瓣膜。
横向开口22开在内表面24和外表面28上。
内假体12的金属网格18可以从具有较小直径的收缩状态伸展成为具有较大直径的扩张状态，这种扩张状态构成其休眠状态。
在图1所示的实施例中，网格18可以自发地从其收缩状态伸展为其扩张状态。在一个变化方案中，使用气球来伸展所述网格。
所述瓣膜14例如可基于动物(例如猪)的天然瓣膜制造。在一个变化方案中，所述瓣膜14可基于天然或合成纤维制造。
所述瓣膜14包括管状的基部30，该基部通过封闭管26的三个瓣32A、32B和32C向上延伸。
基部30具有的外表面与所应用的内假体12的内表面24在形状上基本互补。
在图2显示的实施例中，瓣32A、32B和32C与它们向上延伸的基部30形成一个整体。
瓣32A、32B和32C围绕着内部管26的轴X-X’分布。因此，瓣32A、32B和32C的每一个占据了围绕着轴X-X’的角度为120°的扇形区域。
瓣32A、32B和32C的每一个都是对着内表面24的一部分延伸的袋形膜34的形式。瓣32A、32B和32C的每一个的外部和下部边界都有基本上成U字形的紧固线36，其上部边界为可在内部管26中自由移动的游离边缘38。
紧固线36基本上沿着内假体12的内表面24延伸到两个顶点40，该两个顶点形成游离边缘38的两个侧端点。瓣32A、32B和32C的每个顶点40都是相邻的两个瓣32A、32B和32C共用的端点。
如下文所示，紧固线36专门缝合到中间连接装置16上，并不缝合到内假体12的网格18上。
游离边缘38基本上在内部管26内顶点40之间水平延伸。
如图2所示，游离边缘38和袋34可以在内部管26中的血液压力的作用下，在开放内部管26的开放构型(未示出)和关闭内部管26的关闭构型之间运动。
当处于开放构型时，袋34压住内假体12的内表面24。此时游离边缘38沿着内表面24延伸并且彼此远离。
此时游离边缘38与轴X-X’之间的距离最远。瓣32A、32B和32C在内部管26中占据的面积最小，从而允许血液流过。
当处于关闭构型时，袋34在内部管26内伸展。此时游离边缘38的位置接近轴X-X’。瓣32A、32B和32C的每一个的游离边缘38都几乎全长地压在相邻瓣32B、32C和32A的游离边缘38上。
处于这种构型时，袋34在内部管26中占据的面积最大，基本上阻止了血液从内部管26中流过。
根据本发明，瓣膜14和内假体12之间的连接装置16由与内假体12连接的中间连接部件形成，但是要包括至少一个可相对于内假体12移位的区域。
在本发明的第一种内瓣膜10中，连接装置16由顶部连接细丝50和底部连接细丝52形成，所述顶部连接细丝50用于紧固瓣32A、32B和32C，所述底部连接细丝52用于紧固基部30。
细丝50和52都与内假体12的内表面24和外表面28之间的网格18互相编织在一起。因此，细丝50和52连续地穿过开口22，从而连续地通过细丝区段20的里面和外面。
这样细丝50和52就与内假体相连接，使得它们可以在内假体移动时跟随内假体一起移动较长的距离。
但是，细丝50和52也可以相对于内假体12在它们全长的范围内，或在由固定细丝50和52的每一开口22的大小所限定的一个行程的范围内局部移动。
每条细丝50和52确定了多个位于内假体12外部的外部区域54、多个位于内部管26以内的内部紧固区域56以及多个通过横向孔22连接外部区域54和内部紧固区域56的中间区域58。
顶部连接细丝50形成三个U形跨度60，这三个U形跨度60分别面对每个瓣32A、32B和32C的紧固线36。
瓣32A、32B和32C缝合到内部紧固区域56上。这样瓣32A、32B和32C和细丝50就形成了一个固定在多个横向开口22上的单独组件。
类似地，底部连接细丝52沿着基部30的底边、围绕内表面24的圆周、以轴X-X’为轴延伸。瓣膜14的基部30沿着所述圆周缝合到底部连接细丝52的内部紧固区域56上。
这样，通过由中间连接细丝50和52和瓣膜14共同构成的组件和网格18的共同作用，将瓣膜14整体上相对于管状内假体12固定在一起，以使其可以与内假体12一起移动。由细丝50和52和瓣膜14构成的组件也可以相对于内假体12在开口22中作局部移动，可以移动由每个开口22确定的一个行程。
下面描述本发明的第一种内瓣膜10的操作过程。
首先，在内瓣膜10的装配过程中，将细丝50和52固定在内假体12的网格18上，形成围绕轴X-X’的三个相应的U形跨度60，并使细丝50和52沿着网格18的底部圆周延伸。然后将瓣膜14插入到内部管26中并缝合到细丝50和52的内部紧固区域56上。
然后，将内假体12收缩至其收缩状态，并通过用于在生物体内释放内瓣膜10的释放装置(未示出)将内假体12保持在这一状态，而该释放装置由例如本申请人在法国专利FR-A-2 863 160中所述的外鞘或细丝释放系统构成。
然后，通过例如管腔内方法，将装有内瓣膜10的释放装置植入至患者体内的待植入位置。
当内瓣膜10位于面对植入位置处，即位于天然瓣膜附近时，操作释放装置以使得内瓣膜10由其收缩状态伸展为其扩张状态。这样内假体12的外表面28会压紧血管壁。内假体12从而形成与其所处的血管的切面形状基本互补的切面。
然而，即使当网格18并未以轴X-X’为轴均匀地伸展时，也就是说当网格18的一些横向开口22比其他开口形变程度更大时，在瓣膜14上产生的任何应力都可被瓣膜14和细丝50和52在开口22中相对于网格18的局部运动所释放。这就使得瓣膜14处于比较松弛的状态，由此增加了瓣膜长时间工作的可靠性。
而且，由于瓣膜14仅仅通过中间连接细丝50和52被紧固，并未直接紧固在构成网格18的细丝区段20上，因此内假体12的网格18从收缩状态向扩张状态的伸展并不受瓣膜14的影响，这使得内假体12的释放更容易。
在一个变化方案中，细丝50和52围绕内假体12的外表面28放置。细丝50和52被紧固在网格18的某些点上，例如在其周长的至少三个点上。
瓣膜14通过横向开口22紧固在细丝50和52上，该紧固点位于细丝50和52与网格18的紧固点之间的游离区域。
在另一个变化方案中，瓣膜14具有管状壁，该管状壁围绕并支撑着瓣32A、32B和32C。管状壁被压在内表面24上。
这样，顶部细丝50形成了一个基本为圆形的轮廓，底部细丝52也与此类似。然后将瓣膜14的管状壁紧固在细丝50和52上。
本发明的第二种内瓣膜70与第一种内瓣膜10不同，区别在于第二种内瓣膜70的连接装置16包括形式为编织带72和74的中间部件，所述带72和74的形状基本上与瓣膜14的缝合线36的形状互补。因此，顶部紧固带72形成了三个U形跨度60，这三个U形跨度60通过它们的顶点彼此缝合在一起。下部带74为环形。
例如，带72和74可使用针织或编织好的生物相容织物例如Dacron制造。
带72和74压在内假体12的外表面28上，在内部管26的外面，并通过穿过开口22的缝合针脚76与瓣膜14相连接。
这第二种内瓣膜70的操作过程与第一种内瓣膜10基本相同。
图5显示了一种变化方案的一部分，在这个变化方案中，紧固带72A包括三个彼此不相连的独立的跨度60A、60B和60C。跨度60A、60B和60C的每一个分别紧固在相应的瓣32A、32B和32C的紧固线36上。
本发明的第三种内瓣膜80(示于图6和图7)与第二种内瓣膜70不相同，区别在于第三种内瓣膜80的连接装置16的中间连接部件由单个编织套82形成，该编织套82围绕内假体12的外表面28固定。
套82的高度基本上与瓣膜14的高度相同。通过缝合针脚84，可使得套82通过横向开口22牢固地与瓣32A、32B和32C和基部30固定在一起。
这第三种内瓣膜80的操作过程与第一种内瓣膜10或第二种内瓣膜70基本相同。
在图6中用虚线显示了一种变化方案，在该变化方案中，套82形成了三个U形凹口120，每个凹口120分别沿着瓣32A、32B和32C的紧固线36面对瓣32A、32B和32C延伸。套82的顶部边缘形成凹口120向上的开口，这样一来，血液的流动就能使瓣32A、32B和32C从它们贴在内表面24上的释放构型变成能关闭内部管26的关闭构型。
在图1中用虚线显示了一种变化方案，在该变化方案中，顶部细丝50带有一个从外表面28上向外伸出的环100，这使得可以通过拉动细丝50而回收内瓣膜10，具体回收方法记载于本申请人的法国专利申请06/02932中。

Claims (10)

1.一类内瓣膜(10；70；80)，这类内瓣膜包括：
—一个可在收缩状态和扩张状态之间伸展的内假体(12)，所述内假体(12)形成了一个内部管(26)；
—一个置于内部管(26)中的瓣膜(14)，所述瓣膜(14)可在关闭构型和开放构型之间移动，当瓣膜处于关闭构型时可使所述内部管(26)关闭，当瓣膜处于开放构型时可使所述内部管(26)开放；以及
—瓣膜(14)和内假体(12)之间的连接装置(16)；
其特征在于，所述连接装置(16)包括至少一个与内假体(12)相连接的中间连接部件(50，52；72，74；82)，所述中间连接部件包括至少一个能相对于内假体(12)移动的区域(56)，所述瓣膜(14)固定在所述可移动区域(56)上或固定在至少一个可移动区域(56)上。
2.根据权利要求1的内瓣膜(10；70；80)，其特征在于所述内假体(12)包括侧壁，所述侧壁形成至少一个开到内部管(26)的横向开口(22)，该横向开口(22)通过侧壁(18)开到内假体(12)的外部，所述内假体还包括由中间连接部件(50，52；72，74；82)和固定在所述横向开口(22)上的瓣膜(14)形成的组件。
3.根据权利要求2的内瓣膜(10；70；80)，其特征在于由瓣膜(14)和中间连接部件(50，52；72，74；82)形成的组件可以相对于所述侧壁(18)在由所述横向开口(22)确定的一个行程的范围内局部移动。
4.根据权利要求2或权利要求3的内瓣膜(10；70；80)，其特征在于所述中间连接部件(50，52；72，74；82)具有位于内假体(12)外部的外部区域(54)，和通过内假体的横向开口(22)连接所述或每一个可移动区域(56)的中间区域(58)。
5.根据前述权利要求任一项的内瓣膜(10；70；80)，其特征在于中间连接部件(50，52；72，74；82)可沿着其全长相对于内假体(12)局部移动。
6.根据前述权利要求任一项的内瓣膜(10；70；80)，其特征在于所述中间连接部件(72，74；82)置于内假体(12)外部，所述瓣膜(14)沿着紧固线(36)通过在内假体(12)中形成的至少一个横向开口(22)固定在所述中间连接部件(72，74；82)上。
7.根据权利要求6的内瓣膜(70)，其特征在于所述中间连接部件(72，74)的形状基本上与紧固线(36)的形状互补。
8.根据前述权利要求任一项的内瓣膜(10)，其特征在于所述中间连接部件(50，52)为细丝结。
9.根据前述权利要求任一项的内瓣膜(70)，其特征在于所述中间连接部件(72，74)为带状结构。
10.根据前述权利要求任一项的内瓣膜(80)，其特征在于所述中间连接部件(82)为环绕内假体(12)的管状套。
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US20080147183A1 (en) 2008-06-19
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