CN1328436A - 用锚形体和一个外部护套进行组织固位的心脏瓣膜 - Google Patents
用锚形体和一个外部护套进行组织固位的心脏瓣膜 Download PDFInfo
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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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
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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
- A61F2/2415—Manufacturing methods
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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
- 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
Abstract
本发明公开了一种以准备好的自体组织制造心脏瓣膜的装置和方法。三个组织叶片通过组织锚形体支持定位在一个组织固定骨架上,该骨架具有一个圆环形的基底和多个从基底上伸出的接合柱。一个弹性护套轻靠在组织叶片上以防止组织叶片从锚形钩上脱落并且将叶片包围以形成瓣尖。叶片在其接合线上相互接触,接合线相对于接合柱成大约65度的角。该心脏瓣膜能够在外科手术进行时在很短的时间内制造出,典型的时间是10分钟。小的接合角度和叶片被支持定位并不被夹紧在两个不易屈服的元件之间使得组织上的应力能够最小化。
Description
本发明涉及利用自体组织对心脏瓣膜作出的改进,其中自体组织通过锚形体和一个外部护套支持定位。该心脏瓣膜能够在外科手术进行的同时在很短的时间内制出,典型的是10分钟。
目前已有几种类型的心脏瓣膜用于替换人体内患病或不能正常工作的心脏瓣膜。
其中一种心脏瓣膜是用动物组织制造的,特别是用牛的或猪的大动脉瓣膜组织。这些瓣膜典型的是在需要之前必需将它们在实验室内制好然后储存在醛溶液中。这些瓣膜还需要熟练的技术人员装配。用动物组织制造的瓣膜其寿命相对较短。造成短寿命的原因有两个因素。第一是人体对动物组织具有能引起组织钙化的抗原反应,随着时间的推移该反应使组织变得没有柔韧性并且更容易感染而衰竭。第二是为了尽量降低抗原反应,在移植之前该组织通常储存在戊二醛内。醛容易使该组织具有像皮革一样的坚松度,这使其在开启和关闭的重复应力下不会受到磨损。
因此,尽管动物组织瓣膜得到了广泛的应用,但是大约五到十年后它们还得再更换。因为更换瓣膜需要再次打开心脏并且在手术期间会可能出现伴随的问题,因此会给病人带来危险。
机械心脏瓣膜也能够应用。这些瓣膜是用坚硬的非生物材料如金属或陶瓷制成的。尽管机械心脏瓣膜耐用,但是瓣膜上坚硬的非生物材料表面容易引起血液凝结。血液凝结会引起心脏病发作,因此带有机械心脏瓣膜的病人必需服用抗凝血剂药品。这些药品会引起出血并发症。同时服用这些药品的病人需要经常并且终生化验他们的凝结时间。
另一种类型的心脏瓣膜,自体组织瓣膜,是用病人自己的组织制成的。许多关于自体组织瓣膜以及制造自体组织的方法的专利已经授予了自生公司(AUTOGENICS),即这些申请的受让人,其中包括美国专利No.5,161,955和No.5,326,371。
本发明提供了一种用于制造自体心脏瓣膜的改进的装置和方法。本发明的一个要点在于自体组织的结构和用于将其连在瓣膜骨架上的方法都可以防止在组织内产生有害的应力。
自体组织的精确定位是通过将从病人身体上取得的包心膜组织制成三个单独的组织叶片且每个叶片通常成半圆形并沿着一条组织尖点线(tissue cusp line)具有多个组织锚形体孔实现的。这些组织锚形体孔的位置与永久连在组织固定骨架上的锚形钩相一致。
三块组织叶片顺序地放置在组织固定骨架上的组织锚形钩上使得它们完全围绕着组织固定骨架的周围就位。一个弹性护套伸展至组织固定骨架的整个外表上。该护套用于防止组织从组织锚形钩上脱落并沿尖点线轻靠在组织上以使组织形成一个自然封闭的瓣膜。
本发明的一个重要特征在于支撑自体组织的方式能防止在组织上产生有害的应力。由此组织不是夹紧在两个不易屈服的元件之间,而是通过配合在组织锚形钩孔内的锚形钩与同组织叶片周边部分接合的弹性护套的结合被支撑和保持在弹性护套件与内部组织固定骨架之间。
本发明的另一个特征在于组织叶片包括充分的多余组织区域以提供一个生理上有代表性的接合线角度,从而减少由护套支持定位的组织的伸展并进而减少组织内的应力。
图1为根据本发明制造的装配自体心脏瓣膜的一个优选实施例的透视图;
图2A为组织固定骨架的内部骨架部分制造期间的主视图;
图2B为组织固定骨架的外部骨架部分制造期间的主视图:
图3A为外部骨架卷成圆筒形结构后的透视图;
图3B为内部和外部骨架同心地联结在一起的透视图;
图3C为一个带有组织锚形体的完整组织固定骨架在没有用布覆盖前的透视图;
图3D为其中一个接合柱锚形体的放大视图;
图4为接合组织锚形体的一个放大视图;
图5为尖点组织锚形体的一个放大视图;
图6为图3沿线6—6剖开后的剖面图;
图7A为其中一个自体组织叶片的主视图;
图7B为图7A中的自体组织叶片的主视图,其中显示了在接合吊钩上用于叠覆组织叶片的多余组织;
图8为图6具有两个增加的叠覆自体组织叶片的剖视图;
图9A为弹性护套的透视图;
图9B为图9A沿线9B—9B剖开后的剖视图;
图10A为同组织固定骨架相连的弹性护套的透视图;
图10B为图10A所示弹性护套的主视图;
图10C为图1沿线10C—10C剖开后的剖视图;
图11A为图1沿线11A—11A剖开后的剖视图;
图11B为图1沿线11B—11B剖开后的剖视图;
图11C为图1沿线11C—11C剖开后的剖视图;
图12A为圆环形缝纫环在用布覆盖前的透视图;
图12B为图12A沿线12B—12B剖开后的剖视图:及
图13显示了本发明优选实施例减小了的接合角θ。
图1所示为本发明装配的自体心脏瓣膜9的一个优选实施例。该瓣膜使用的是病人自己的组织并且在外科手术进行时用一些工厂制造出的组件来制作。参考图3C和图7A,这些组件包括一个组织固定骨架40(图3C),其具有多个组织锚形体34和36。在该组织固定骨架40上固定有三个单独的自体组织叶片50,其中一个如图7A所示。三个叶片的最终装配结构如图1中90所示。一个弹性外部护套42覆盖在组织固定骨架的外面上并帮助将组织支持定位在骨架上同时对组织叶片不施加不适当的应力。一个圆环形的缝纫环70安装在组织固定骨架和弹性护套的底部并用于在病人体内以传统的方式支持装配瓣膜定位。如下所述,该瓣膜是在打开心脏期间由外科医生在外科手术进行时装配,典型的装配时间是10分钟左右。
组织固定骨架40
在图2A,2B,3A,3B,3C,3D,4和5中示出了组织固定骨架40的组件。图2A所示为内部骨架10,其最好是具有一个基底12并具有三个从基底上伸出的接合柱14。在图1所示的瓣膜中,这些接合柱14在血液流过瓣膜的方向上沿瓣膜的轴线放置。优选的是三个接合柱14沿内部骨架均匀地间隔开以便当内部骨架装配时,三个接合柱相互间隔120度。接合柱最好是与扇形的壁体16连接,内部骨架的端部18最好是倾斜一个角度而不是与基底12垂直。在扇形壁体16和接合柱14的周边上具有多个内部骨架孔20。
内部骨架10可以由多种适合体内应用的材料制成,包括一定的金属和塑料。作为制造材料,金属通常比塑料要好,埃尔基洛伊(ELGILOY)耐蚀游丝合金是一种特别优选的制造内部骨架10的金属。迭尔林(DELRIN)是一种特别优选的塑料。
图2B所示为组织固定骨架的外部骨架24部分。像内部骨架一样,外部骨架是由一个基底12a和多个由扇形壁体16a连在一起的接合柱14a构成。外部骨架的端部18a最好也是倾斜的。沿着尖点线30有多个外部骨架孔16a,该尖点线在图2B中表示为虚线。尖点线30位于靠近扇形壁体16a和接合柱14a的边界。内部骨架孔和外部骨架孔的数量依赖于瓣膜尺寸的大小但其通常是在21—24个的范围内。如下所述,当内部骨架和外部骨架装配在一起时,外部骨架孔与相应的内部骨架孔并置。外部骨架可以用包括金属和塑料在内的多种材料制造。埃尔基洛伊耐蚀游丝合金是一种特别优选的材料。
焊接区域32的位置如图2B中的剖面线所示部分。该焊接区域确定了外部骨架24内表面上与内部骨架10的外表面相焊接以把两个骨架永久结合在一起的区域。
内部骨架10和外部骨架24卷成一个圆筒形的结构。由于两个圆筒形元件的外形非常相似,所以在图3A中只显示了外部骨架24。然后两个元件10和24同心地装配在一起并绕着基底12的焊接区域32进行点焊以形成图3B所示的构件。当两个骨架焊接在一起时骨架的端部18和18a相隔120度。
接合柱锚形体34(图4)和尖点线锚形体36(图5)是用金属制成,最好是用埃尔基洛伊耐蚀游丝合金制成。每个锚形体34和36都包括一个弯钩部分和一个扁尾部分(34a和36a),后者用于将锚形体永久地固定在组织固定骨架40上。弯钩部分从结合在一起的内部和外部骨架圆筒的里面插入并穿过内部骨架孔20和外部骨架孔26以便其从外部骨架的表面伸出(如图3C和3B所示)。通过内部骨架10上相应较大的内部骨架孔20将扁尾部分36a同外部骨架24的内表面点焊在一起。如图6所示,扁尾部分34a同外部骨架24的内表面邻接并位于较大的相应内部骨架孔20内。如图4和图5所示,下面将会清楚,接合柱锚形体34比尖点线锚形体36稍大,因为接合柱锚形体34支撑两层组织而不是像尖点线锚形体36支撑一层组织。
图3D是接合柱锚形体34一个更详细的视图,其中锚形体34从外部骨架24上的外部骨架孔26内伸出。通过内部骨架10上较大的内部骨架孔20(未示出)将接合柱锚形体同外部骨架24的内壁点焊在一起。
如图3C,3D和6所示,接合柱锚形体34上的弯钩部分朝向上方,而图3C中尖点线锚形体36的弯钩部分朝向远离尖点线30的方向并指向下方。通常但不是必需,在每个接合柱14上具有两个接合柱锚形体。
打开心脏进行外科手术期间在外科医生移去病人的瓣膜之后为了适应病人的特殊需要,组织固定骨架40制造成几种不同尺寸。目前所用瓣膜的典型尺寸包括19,21,23和25mm。尖点线锚形体的数量是变化的,其依赖于组织固定骨架尺寸的大小。通常每个瓣膜上具有6个接合柱锚形体(每个柱体上两个)和15—18个尖点线锚形体。尖点线锚形体的数量依赖于瓣膜尺寸的大小。
图6为装配的组织固定骨架40一侧的剖面图,其中显示了内部骨架10,外部骨架24及接合柱锚形体34。两个接合柱锚形体34通过内部骨架孔20同外部骨架24的内壁点焊在一起。尽管图中未显示,尖点线锚形体34也以相似的方式同骨架40的下端部分焊接在一起。
在内部骨架10,外部骨架24,接合柱锚形体34及尖点线锚形体36装配并焊接在一起后,用DACRON布38将装配的组织固定骨架40的两侧覆盖(见图11)。DACRON是杜邦公司对聚对苯二甲酸乙二醇脂的注册商标名称。
由于在图中难以对布进行表示,下面对图10C,11B和11C进行描述时,其中覆盖固定骨架40,护套42以及缝纫环70的DACRON布用虚线38表示。接合柱锚形体34和尖点线锚形体36从DACRON布内伸出。如上所述,点焊的锚形体同内部骨架的内侧表面几乎平齐仅稍微突出(典型的是突出0.003英寸)。因此,当用DACRON将骨架覆盖时,除了DACRONDE的纺织表面,内表面是光滑的。用DACRON覆盖骨架能将非生物材料如骨架金属同人体隔离。同时将非生物材料同人体隔离并使其和心脏成为一个整体还能实现促进组织向布的空隙内生长的目的。这有助于避免血栓栓塞的问题。另外,还能够在瓣膜的金属与塑料组件和组织之间提供柔和的接触面并且通过允许血液自由地流向组织有助于培育组织和促进它的生存能力。
尽管可以用多种方法来准备覆盖骨架的DACRON,但是美国专利No.5,163,955描述了一种有益的方法,该专利在这里合并作为参考。该专利中描述了一种具有三个指的DACRON软护套或手套,如该专利的图4A所示。该三指软护套是通过用热丝,热烙铁或超声波技术对DACRON布的接缝部分加热制成的。另外,整个手套还可以纺织或编织为一个整体。然后把该手套翻过来(以从血流中除去接缝)套在组织骨架上,并用一个热接缝将其固定在手套基层上。类似的纺织方法也可以用于此处描述的其他DACRON保护套中。
自体组织叶片
自体组织叶片50大致成一个半圆形,如图7A所示,下面对叶片的详细内容包括其形成方式进行描述。组织叶片50上沿组织尖点线62具有多个组织锚形体孔58,其中组织尖点线62在图7A中以虚线表示。组织叶片斜面66最好是在组织叶片的一个角上切出以识别哪个叶片放在上端并与前面叶片的一部分重叠。在外科手术进行时制造瓣膜期间,这些组织孔58套在接合柱锚形体34和尖点线锚形体36上以使组织叶片在装配的组织骨架上恰当地被定位。组织叶片50同接合柱锚形体34的固定如图8所示。如图所示,通过把组织叶片50a和50b穿在接合柱锚形体34的弯钩部分上使重叠的组织叶片50a和50b固定在组织固定骨架40上。因此,每个接合柱锚形体34上固定有两层组织叶片50。然而,在骨架的下端部分只有一层组织叶片并没有叶片重叠。尖点线锚形体36具有一个弯钩部分,其从骨架40伸出的不是那么多。
弹性护套
弹性护套42如图9A所示。该弹性护套42通常具有和组织固定骨架类似的形状,其具有一个环形弹性基座44和三个从基座上伸出的弹性护套接合柱46。弹性护套接合柱46之间通过弹性护套的扇形壁体48相连。弹性护套42具有多个弹性护套孔64,它们在位置和数量上与骨架40上的接合柱锚形体34和尖点线锚形体36相一致。弹性护套42最好是用硅橡胶制造并用DACRON布将其两侧覆盖。
图9A,10A,10B,10C,11A和11B是弹性护套42另外的视图。需要指出的是,图10A,10B,和11A是用以说明目的的其中仅表示出了弹性护套42与骨架40之间的固定而没有显示自体组织叶片50。在制造瓣膜期间由于首先是在护套42就位后通过组织锚形体34和36将叶片固定在组织固定骨架40上,因此上述图示情况不会发生。图9中弹性护套42的剖面部分在某种程度上像是一个倒立的“J”形并具有两个与弹性护套基座44毗邻的边缘。弹性护套42设计成能够在固定有三个叶片50的装配骨架结构外面伸展。当弹性护套42在装配骨架结构的外面伸展时,组织锚形体34和36就能宽松地位于DACRON覆盖的弹性护套孔64内,如图11B所示。
外部弹性护套倒立“J”形部分的顶端安装在骨架40上接合柱14顶部的上面。组织叶片50同接合柱锚形体34和尖点线锚形体36相固定然后被保持在弹性护套42的内壁与组织固定骨架40之间。弹性护套孔64用于容纳从组织内伸出的接合柱锚形体34和尖点线锚形体36的弯钩部分。图10A显示了接合柱锚形体34和尖点线锚形体36配合在弹性护套孔64内时的情形。
弹性护套42是通过其DACRON覆盖层与装配骨架的基层固定在一起的,其中通过热焊,缝合,或缝纫将其同装配骨架的DACRON覆盖层结合在一起。通过位于外部弹性护套倒立的“J”形部分顶部的弹性护套凹穴48,弹性护套42还被保持在骨架的接合柱14顶部的合适位置上(图11B)。
缝纫环
图11A,11B,11C,12A和12B中所示的DACRON覆盖的缝纫环70位于装配瓣膜的底部。该缝纫环具有一个楔形截面并且最好是用硅橡胶制成,也可以应用其他具有柔韧性,弹性和耐用的材料。该缝纫环又薄又有柔韧性以便当瓣膜植入人体内时其能够与大动脉根的扇形形状保持准确的一致。
缝纫环,组织固定骨架和弹性护套通过在热焊点110将所有六层DACRON联结在一起而结合在一起,如图11B和11C所示。热焊点110是通过缝纫环与组织固定骨架几乎平齐形成的。当缝纫环移到图11B所示位置时,焊点就隐藏于缝纫环与外部护套之间。这可以防止在焊接相对光滑的表面上形成血栓栓塞。
组织固定骨架,组织锚形体及弹性护套组成一个成套元件,其能够在工厂里预先装配并运送到手术室内应用。该成套元件可以在工厂里安装在一起和将弹性护套与组织固定骨架组合。组织固定骨架和弹性护套最好是用DACRON覆盖起来,并且如上所述DACRON层利用图11B和11C中所示的热焊点110焊接在一起。
该成套元件还可随意地额外包括一个同组织固定骨架和弹性护套相固定的缝纫环。该缝纫环最好也用DACRON覆盖并且如上所述该缝纫环通过在热焊点将六层DACRON焊接在一起同组织固定骨架和弹性护套相固定。
自体组织叶片的准备
通常每个组织叶片的形状如图7A所示。该形状设计成扇形形状并使组织的应力最小化。组织沿组织尖点线94的长度比图2B所示组织骨架的尖点线30的长度稍长,因此多余的组织能够形成一个杯形,工艺上与形成女士服装中的束胸的工艺类似。尽管组织比所需要的尖点线长度要大,但是还不至于引起组织折叠或起皱。
有代表性的是组织叶片是利用一个组织切割模切割成的,该切割模的结构既能满足最终瓣膜的尺寸也能在叶片的一侧提供额外的组织。美国专利No.5,163,955和5,425,741中显示并描述了适于将自体组织裁剪成预定形状的切割模具的实例。在优选实施例中,将会供应一次性的组织切割模并且用在一个护套内,该护套可能不是一次性的。
对于本发明中的使用,切割模的结构要满足组织叶片50以这样一种方式切割,即要考虑用于在接合柱14上重叠所需的额外组织,如图11B所示。其组织在接合柱上并位于毗邻叶片(图11B中的叶片叶片50a)上面的叶片沿着结合线的半径由覆盖内部叶片所需的额外量延长。该切割模或其他切割装置的结构能够在叶片的一侧提供额外的组织,并能斜切所切割叶片的一角以识别哪一个叶片放置在前面叶片的上面。组织叶片的切角66如图7A所示。
位于上面组织叶片具有较长长度的一侧如图10C所示。其组织位于毗邻叶片(图11B中的叶片叶片50a)上面的叶片沿着结合线的半径由覆盖内部叶片所需的额外量延长。图7B中阴影线区域98为从组织叶片中心线量起的额外组织量。
除了组织切割模以外,也可以采用其他外科手术技术以精确切割组织叶片,例如水喷射或激光切割装置。
本发明该优选实施例的一个特征是其不需要水平的接合线。如图13所示,这样一条水平接合线104大大增加了接合柱14上组织的应力。这类似于与一条允许有弯曲的凉衣服绳子相比要保持凉衣服绳子非常绷紧所需要的张力。根据本发明该优选实施例制造的心脏瓣膜,外部弹性护套42支持着组织叶片50a和50b绕在组织固定骨架40的接合柱14上。沿接合线的组织长度大于瓣膜半径的两倍。考虑到组织的伸展,额外组织导致形成了一条与接合柱成大约65度夹角的接合线,如图13中标号102所示。接合角θ的减小大大降低了接合柱14上组织叶片的应力。
用于制造组织叶片50的组织最好是自体组织,如包心组织,但是也可以是阔筋膜,直肌筋膜或静脉组织。这些组织源都相对易损坏和不易处理。这是因为,一旦采集下来,这些组织的厚度大约只有10—12密耳(mils)。相比而言,牛的包心膜大约为15—20密耳(mils)厚。组织采集下来后,通常是通过在0.625%的戊二醛溶液中浸泡大约10分钟以使其部分固着。这既能够使组织变得坚韧又能够使其易于处理。
当然除了自体组织其他组织也是可以,如牛的包心膜或其他异种移植组织等类似组织。另外,同种移植组织也是可以的。这些组织可以由瓣膜制造者预先切割下来或在手术室外制造并以传统的方法储藏。然而,如果使用其他的组织源,就要对瓣膜组件的尺寸进行调整以适应组织,这些组织通常要比优选的组织源厚。
外科手术进行时瓣膜的制造
自体组织的清洁,采集和固着工艺在现有技术领域是公知的,如美国专利No.5,163,955中所描述的。
如上所述,在固着之后接下来是采集三块独立的组织叶片。
其尺寸能够叠盖剪切角66(图7A)的三个组织叶片放置在前面叶片的上面。这些叶片顺序地放置在组织锚形钩34和36上,其中组织锚形钩34和36位于被布覆盖的组织固定骨架40上。
然后将弹性护套42折叠并卷起覆盖在骨架40和固定的组织叶片上,以便位于每个弹性护套42上的弹性护套接合柱部分46顶部的凹穴48钩在组织固定骨架40的接合柱14上。在优选实施例中,覆盖弹性护套的DACRON沿尖点线轻靠在组织叶片上(见图11B),以便组织叶片自然地形成图1所示的封闭的瓣膜。护套42用于防止组织叶片50从锚形钩34和36上脱落,同时护套42充分地将接合柱14的上端部分以及固定在其上面的组织叶片包围和“拥抱”起来,如图10C所示,因此毗邻的叶片在接合线上彼此接触。
根据现有技术将完整的瓣膜经过测试然后固定在一个支架上用于移植。见美国专利No.5,163,955。
Claims (45)
1.一种组织心脏瓣膜,该组织心脏瓣膜包括:
(a)一个制造好的组合件,该组合件包括:
一个组织固定骨架,其具有一个通常为圆筒形的基底,三个接合柱及多个向外伸出的组织锚形钩;
一个固定在所述组织固定骨架上的缝纫环;
一个固定在所述组织固定骨架上的弹性护套;及
(b)三个在外科手术进行时剪切下来并具有多个固定孔的自体组织叶片,所述叶片分别固定在相应的组织锚形钩上以使所述叶片绕着所述组织固定骨架的四周顺序就位,每个叶片从一个接合柱伸向毗邻的接合柱并且在每个接合柱上每个所述叶片叠盖在先的毗邻叶片,所述弹性护套(ⅰ)轻靠在所述组织叶片上以防止所述叶片从所述组织锚形钩上脱落,及(ⅱ)将所述接合柱和固定在接合柱上的组织叶片包围以使所述叶片形成瓣尖。
2.一种组织心脏瓣膜,该组织心脏瓣膜包括:
(a)一个制造好的组合件,该组合件包括:
一个组织固定骨架,其具有一个通常为圆筒形的基底,三个接合柱及多个向外伸出的锚形钩;
一个固定在所述组织固定骨架上的缝纫环;
一个固定在所述组织固定骨架上的弹性护套;及
(b)三个在外科手术进行时剪切下来的自体组织叶片,每个叶片(ⅰ)通常为一个半圆形的形状,(ⅱ)其组织沿组织尖点线的长度比所述组织固定骨架沿尖点线的长度稍长,以便当所述组织叶片固定在组织固定骨架上时多余的组织能使叶片形成一个尖角形状,(ⅲ)在每个叶片的一侧具有的额外组织以接纳在所述组织固定骨架的接合柱上叠盖毗邻叶片的所述组织的叠盖部分,及(ⅳ)额外充分的组织,以便当组织叶片固定在所述组织固定骨架上和所述弹性护套内时由毗邻组织叶片的自由边缘确定的接合线不是水平的接合线,及(ⅴ)多个固定孔,所述叶片孔分别固定在所述组织锚形钩上以便组织叶片沿着所述组织固定骨架的四周被顺序固定并且每个叶片从所述接合柱上伸向毗邻的接合柱,所述弹性护套折叠覆盖在所述叶片上以便所述弹性护套(ⅰ)轻靠在所述组织叶片上以防止所述叶片从组织锚形钩上脱落,及(ⅱ)将所述接合柱的上端部分和固定在接合柱上的组织叶片包围,由此(ⅰ)所述叶片形成瓣尖,及(ⅱ)毗邻的叶片沿着所述接合线彼此接触。
3.一种组织心脏瓣膜,该组织心脏瓣膜包括:
(a)一个制造好的组合件,该组合件包括:
一个组织固定骨架,其通常具有一个圆筒形的基底,三个接合柱及多个向外伸出的锚形钩;
一个固定在所述组织固定骨架上的缝纫环;
一个固定在所述组织固定骨架上的弹性护套;及
(b)三个在外科手术进行时剪切下来并由相应组织锚形钩支持的自体组织叶片,所述组织叶片沿着所述组织固定骨架的四周顺序放置,每个叶片从一个接合柱上伸向毗邻的接合柱,同时所述弹性护套(ⅰ)轻靠在组织叶片上以将所述叶片支持在所述组织锚形钩上,及(ⅱ)将所述接合柱的上端部分和固定在接合柱上的组织叶片包围以使叶片形成瓣尖。
4.根据权利要求3所述的组织心脏瓣膜,其中所述组织固定骨架包括一个同一外部骨架相固定的内部骨架。
5.根据权利要求3所述的组织心脏瓣膜,其中所述组织叶片是超尺寸的以促进所述瓣尖的形成。
6.根据权利要求3所述的组织心脏瓣膜,其中所述组织叶片是超尺寸的以便所述弹性护套能支持所述多个组织叶片并具有一个不超过90度的生理上典型的接合角。
7.根据权利要求6所述的心脏瓣膜,其中所述接合线到接合柱的角度大约为60度。
8.根据权利要求3所述的心脏瓣膜,其中所述弹性护套能够自我调整以对所述骨架上的组织叶片施加均匀的力。
9.根据权利要求3所述的心脏瓣膜,其中所述锚形体是吊钩且所述弹性护套具有多个用于容纳所述吊钩的孔口。
10.根据权利要求9所述的心脏瓣膜,其中所述弹性护套内的孔口容纳的是所述吊钩的外围部分。
11.根据权利要求3所述的心脏瓣膜,其中所述弹性护套是在工厂内同所述组织固定骨架结合在一起的。
12.根据权利要求3所述的心脏瓣膜,其中所述组织叶片是通过下述结合支撑和保持的,(ⅰ)将所述叶片内的孔口分别固定在所述组织锚形体上及(ⅱ)所述弹性护套同所述外部弹性护套与所述内部组织固定骨架之间的组织叶片的外围部分接合,同时所述组织在这两个不易屈服的元件之间不被夹紧。
13.根据权利要求3所述的心脏瓣膜,其中所述所述组织叶片包括部分固着的自体组织。
14.根据权利要求3所述的心脏瓣膜,其中所述组织叶片包括部分固着自体包心组织。
15.根据权利要求3所述的心脏瓣膜,其中所述组织固定骨架用织物覆盖。
16.根据权利要求15所述的心脏瓣膜,其中所述织物为聚乙烯对二苯酸脂。
17.一个用于将组织固定在医疗装置上的护套,包括一个有柔韧性,柔软的圆环形主体,该主体用于容纳所述医疗装置和所述组织并将组织支撑在医疗装置上。
18.根据权利要求17所述的护套,其中护套在圆环形的主体中具有多个用以容纳所述医疗装置上吊钩的孔。
19.一种心脏瓣膜,该瓣膜包括:
一个骨架,该骨架包括一个圆环形的基底和多个从所述基底上伸出的柱子;
多个固定在所述骨架上的组织锚形体;
多个由所述组织锚形体支撑的组织叶片;及
一个有柔韧性的弹性护套,其中所述护套配合在所述骨架和所述组织的四周并将所述组织叶片支持在所述组织锚形体上。
20.根据权利要求19所述的心脏瓣膜,其中所述弹性护套包括一个圆环形的基座和多个从所述基座上伸出的柱子。
21.根据权利要求19所述的心脏瓣膜,其中所述组织锚形体为吊钩并且所述组织叶片被支持在所述骨架上的多个吊钩上。
22.根据权利要求19所述的心脏瓣膜,其中所述骨架包括一个内部骨架和一个外部骨架。
23.根据权利要求19所述的心脏瓣膜,其中所述骨架包括一个内部骨架和一个外部骨架,两个骨架绕着它们的基座联结在一起。
24.根据权利要求19所述的心脏瓣膜,其中所述组织叶片是超尺寸的以促进形成瓣尖。
25.根据权利要求19所述的心脏瓣膜,其中所述弹性护套支持着多个连在一起的组织叶片,其中组织叶片的结合角不大于90度。
26.根据权利要求19所述的心脏瓣膜,其中所述弹性护套能够自我调整以便对骨架上的所述组织叶片施加均匀的力。
27.根据权利要求21所述的心脏瓣膜,其中所述弹性护套具有多个用以容纳所述吊钩的孔。
28.根据权利要求19所述的心脏瓣膜,其中所述护套通过所述柱子上的凹穴支撑在所述骨架上。
29.根据权利要求19所述的心脏瓣膜,其中所述弹性护套是在工厂里同所述骨架接合在一起的。
30.根据权利要求19所述的心脏瓣膜,其中所述组织叶片是通过下述结合支撑和保持的,(ⅰ)所述组织锚形体及(ⅱ)所述弹性护套同所述外部弹性护套与所述内部组织固定骨架之间的组织叶片的外围部分接合,同时所述组织在这两个不易屈服的元件之间不被夹紧。
31.根据权利要求19所述的心脏瓣膜,其中所述组织叶片包括部分固着的自体组织。
32.根据权利要求19所述的心脏瓣膜,其中所述组织叶片包括部分固着的自体包心组织。
33.根据权利要求19所述的心脏瓣膜,其中所述骨架用织物覆盖。
34.根据权利要求33所述的心脏瓣膜,其中所述织物为聚乙烯对二苯酸脂。
35.根据权利要求19所述的心脏瓣膜,该瓣膜另外还包括一个有柔韧性的圆环形缝纫环。
36.根据权利要求35所述的心脏瓣膜,其中所述弹性护套和所述圆环形缝纫环同所述骨架固定。
37.根据权利要求19所述的心脏瓣膜,其中所述组织叶片是在瓣膜置换手术进行期间装配在所述骨架上的。
38.用以制造心脏瓣膜的成套元件,该成套元件包括:
一个固定骨架,其包括一个圆环形基底和多个从所述基底上伸出的柱子:
多个固定在所述固定骨架上的锚形钩;
一个有柔韧性的弹性护套,其包括一个圆环形的基座和多个从所述基座上伸出的柱子,其中所述柱子包括用以将所述护套支持在所述固定骨架上的凹穴。
39.根据权利要求38所述的成套元件,该成套元件另外还包括一个同所述固定骨架和所述弹性护套相固定的缝纫环。
40.根据权利要求38所述的成套元件,其中所述固定骨架用织物覆盖。
41.一种装配心脏瓣膜的方法,该方法包括:
从病人身体上切割组织;
将所述组织剪切成具有多个孔的组织叶片;
提供一个骨架,该骨架包括一个圆环形的基底,多个从所述基底上伸出的柱子,及多个同所述骨架相固定的吊钩;
通过将组织孔放在吊钩上把所述组织叶片固定在所述骨架上;及
将所述弹性护套折叠覆盖在所述骨架的接合柱上以包围所述接合柱和固定在所述接合柱上的一部分组织叶片,以将所述叶片制成心脏瓣尖。
42.一种装配心脏瓣膜的方法,该方法包括:
将组织剪切成多个组织叶片;
将所述多个组织叶片固定在一个骨架上,该骨架包括一个圆环形的基底,多个从所述基底上伸出的柱子,及多个同所述骨架相固定的吊钩;及
将所述弹性护套折叠覆盖在所述骨架和所述叶片上以将所述叶片支持在所述骨架上。
43.一个用于制造组织心脏瓣膜的组合件,该组合件包括:
一个组织固定骨架,其通常具有一个为圆筒形的基底,多个接合柱,及多个向外伸出的组织锚形体;
一个同所述组织固定骨架相固定的缝纫环;
一个同所述组织固定骨架相固定的弹性护套。
44.一个用于将组织叶片固定在一个心脏瓣膜组织固定骨架上的弹性护套,所述弹性护套包括一个圆环形基座和多个从所述基座上伸出的柱子,其中所述护套是用有柔韧性、柔软的材料制成的并具有多个用于容纳所述固定骨架上吊钩的孔。
45.根据权利要求44所述的弹性护套,其中所述护套具有一个倒立的“J”形截面。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US09/161,809 US6334873B1 (en) | 1998-09-28 | 1998-09-28 | Heart valve having tissue retention with anchors and an outer sheath |
US09/161,809 | 1998-09-28 |
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CN1328436A true CN1328436A (zh) | 2001-12-26 |
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Application Number | Title | Priority Date | Filing Date |
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CN99811423A Pending CN1328436A (zh) | 1998-09-28 | 1999-09-22 | 用锚形体和一个外部护套进行组织固位的心脏瓣膜 |
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US (2) | US6334873B1 (zh) |
EP (1) | EP1117354A1 (zh) |
JP (1) | JP2002525169A (zh) |
CN (1) | CN1328436A (zh) |
AU (1) | AU6259499A (zh) |
WO (1) | WO2000018333A1 (zh) |
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-
1998
- 1998-09-28 US US09/161,809 patent/US6334873B1/en not_active Expired - Lifetime
-
1999
- 1999-09-22 WO PCT/US1999/021997 patent/WO2000018333A1/en not_active Application Discontinuation
- 1999-09-22 CN CN99811423A patent/CN1328436A/zh active Pending
- 1999-09-22 JP JP2000571856A patent/JP2002525169A/ja active Pending
- 1999-09-22 AU AU62594/99A patent/AU6259499A/en not_active Abandoned
- 1999-09-22 EP EP99949797A patent/EP1117354A1/en not_active Withdrawn
-
2001
- 2001-10-16 US US09/982,609 patent/US20020026238A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US20020026238A1 (en) | 2002-02-28 |
WO2000018333A1 (en) | 2000-04-06 |
AU6259499A (en) | 2000-04-17 |
EP1117354A1 (en) | 2001-07-25 |
US6334873B1 (en) | 2002-01-01 |
JP2002525169A (ja) | 2002-08-13 |
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