CN1404376A - 假体心瓣膜 - Google Patents
假体心瓣膜 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
- A61F2/2412—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
- 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
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/64—Animal cells
Abstract
一种管状假体半月瓣或房室瓣心瓣膜通过按照要求图案切割平而柔韧的叶片而形成。该瓣膜的构造是通过对齐相邻叶片的侧边缘,使叶片内表面彼此接合,然后沿毗邻侧边缘的一条折叠线将这些叶片缝合在一起。针脚从每个叶的近端流入端延续到远端的流出端。工作期间,当这些叶片打开和关闭时,这些叶片沿折叠线折叠。远的短小突出部分延伸到每个叶片远端之外。这些连续的针脚终止于远的短小突出部分的近端,从而使得沿折叠线远端部分不存在锁定的针脚。相邻叶片的短小突出部分彼此折叠并缝合在一起,形成缝合的连接短小突出部分。这些缝合的连接短小突出部分提供了适合缝合等的缝合连接点,以便将短小突出部分固定于半月瓣的血管壁上和房室瓣的乳头肌和/或腱索上。
Description
发明背景
发明领域
本发明涉及心瓣膜,尤其涉及患病或受伤心瓣膜的替代物。
相关技术描述
心脏中有四个瓣膜,用于引导血液流动通过心脏两侧。心脏的左(系统)侧是:(1)二尖瓣,它位于左心房和左心室之间,及(2)主动脉瓣,它位于左心室和主动脉之间。这两个瓣膜引导来自肺的富氧血液通过心脏左侧并进入主动脉,从而分布到身体中。心脏的右(肺)侧是:(1)三尖瓣,它位于右心房和右心室之间,及(2)肺动脉瓣,它位于右心室和肺动脉之间。这两个瓣膜引导来自身体的脱氧血液通过心脏右侧并进入肺动脉中,从而分布在肺内,在这里这些血液被重新充氧以便开始新的循环。
心脏的所有四个瓣膜都是被动结构,它们自己不消耗任何能量,不完成任何积极的收缩功能。它们由可活动的“叶片”构成,这些叶片根据瓣膜任一侧的压力打开和关闭。二尖瓣和三尖瓣被称为“房室瓣”,因为它们位于心脏每一侧的心房和心室之间。二尖瓣有两个叶片,三尖瓣有三个叶片。主动脉瓣和肺动脉瓣由于它们叶片独特的外观而被称为“半月瓣”,它们的形状有点像半个月亮,它们可以更适合被称之为“尖头”(cusps)。主动脉瓣和肺动脉瓣每个都有三个尖头。
由于先天或后天的瓣膜疾病,心瓣膜可能会出现异常组织和功能。先天瓣膜异常可以很好地忍受多年,直到发展到危及老年患者寿命,或严重到出生后几小时内必须进行急症外科手术。后天瓣膜疾病的起因可能是例如风湿、瓣膜组织退化病症、细菌或真菌感染及创伤。
由于心瓣膜是被动结构,它们只是根据特定瓣任一侧上的不同压力简单地打开和关闭,瓣膜可能出现的问题可以分成两类:(1)狭窄,其中一个瓣膜不能够适当地打开,及(2)机能不全(也叫反流),其中一个瓣膜不能够适当地关闭。狭窄和机能不全可能在相同或不同的瓣膜内伴随出现。这些异常增加了心脏的工作负担。对心脏和患者压力增加的严重性和心脏对它的适应能力决定了是否必须用外科手术替换(在某些情况下是修复)异常瓣膜。
瓣膜修复和置换瓣膜外科手术在很多书和文章中都有描述和说明,可以有很多选择,包括人工机械瓣膜和人工组织瓣膜现在都可用。但是,现在可行的选择不能够复制先天(天然)心瓣膜的优点。一些可用的机械瓣膜非常耐久,但是问题在于它们形成血栓,血液动力学性能较差。一些可用的人工组织瓣膜形成血栓性相对较低,但是缺乏耐久性。此外,这些人工组织瓣膜甚至常常不具有接近先天瓣膜的良好血液动力学性能的血液动力学性能。一些人工组织瓣膜试图复制先天心瓣膜的形式;这种瓣膜仍然缺少耐久性和血液动力学性能。
James L.Cox,M.D.观察到在先天胚胎发展过程中,人类心脏开始是一种简单的管状结构,在发展当中基于其生理作用改变了形式。Dr.Cox根据其研究和基于“形式服从功能”的原理研制了一种管状人工心瓣膜。该原理对心瓣膜可以重述为:“如果人工瓣膜能够像先天瓣膜一样起作用,那么其最终形式将非常类似先天瓣膜的形式”。Dr.Cox根据该原理研制的假体心瓣膜描述和公开于美国专利US5480424、5713950和6092529中。其中每项专利在此全部引入作为参考。
Dr.Cox的工作已经导致了有前景的心瓣膜技术,能够将假体心瓣膜的发展引向获得先天心瓣膜的全部功能。这样的瓣膜应该耐久、不形成血栓,并应该表现出良好的血液动力学性能。
发明概述
因此,本领域需要一种改进的具有良好血液动力学性能、不形成血栓和耐久性好的假体心瓣膜。
根据本发明的一个方面,一种无移植片固定模的(stentless)假体心瓣膜包括多个薄的柔性叶片,每个柔性叶片具有一个内表面,一个外表面,一个流入边缘,一个流出边缘和几个侧边缘。多个叶片沿其至少一部分侧边缘缝合在一起,以便形成一个具有流入端和流出端的大体为管状的瓣膜结构。相邻的叶片设置成使它们的边缘基本对齐,并且几个叶片的内表面靠近这些侧边缘彼此接合。该瓣膜结构可在关闭位置和打开位置之间活动,在关闭位置时相邻叶片的流出边缘相互接合,在打开位置时相邻叶片的流出边缘除了沿这些侧边缘之外相互分开,从而使叶片侧边缘的缝合部分向部分关闭位置偏离。
根据本发明的另一方面,一种无移植片固定模的假体心瓣膜包括三个薄的柔性叶片,每个柔性叶片具有一个内表面,一个外表面,一个流入边缘,一个流出边缘,几个侧边缘和几个向外延伸超出侧边缘并靠近流出边缘的短小突出(tab)部分,使这些叶片沿它们的侧边缘相互连接,从而形成一个具有流入端和流出端的大体为管状的瓣膜结构。相邻叶片的短小突出部分相互接合,形成缝合的连接短小突出部分,至少每个缝合的连接短小突出部分的一部分靠近相邻叶片的外表面。
根据本发明的又一方面,一种无移植片固定模的假体心瓣膜包括具有一个叶片主体的第一叶片,该主体具有一个内表面,一个外表面,一个近端,一个远端,一个第一侧边缘,和一个邻近该远端并从该第一侧边缘延伸的第一短小突出部分,该第一短小突出部分通过一个第一颈部连接于第一叶片主体;及具有一个叶片主体的第二叶片,该主体具有一个内表面,一个外表面,一个近端,一个远端,一个第二侧边缘,和一个邻近该远端并从该第二侧边缘延伸的第二短小突出部分,该第二短小突出部分具有一个纵向槽并通过第二颈部连接于第二叶片主体。第一叶片的第一侧边缘和第二叶片的第二侧边缘基本上相互对齐并相互连接,第一叶片和第二叶片的内表面靠近对齐的侧边缘相互接合。第二短小突出部分折叠,以便使第一和第二颈部延伸通过第二短小突出部分的纵向槽。此外,这些叶片的颈部不缝合。
根据本发明的再一方面,一种制造无移植片固定模的管状假体心瓣膜的方法,包括如下步骤:提供一段基本扁平的柔性材料,从该扁平材料上切割出多个叶片,使每个叶片都具有一个内表面,一个外表面,一个近端,一个远端,几个侧边缘,和几个邻近该远端并从侧边缘延伸的短小突出部分,对齐相邻在一起的叶片侧边缘,以便使相邻叶片的内表面靠近这些侧边缘相互接合,及将对齐的侧边缘缝合在一起,从而形成一个具有一个流入端和一个流出端的大体为管状的瓣膜结构。此外,该多个叶片可以使用一种非接触型切割装置完成,例如但不限于激光。
本发明的另一方面是一种制造假体心瓣膜的方法,包括如下步骤:提供第一瓣膜叶片和第二瓣膜叶片,这些叶彼此分开成型,将第一瓣膜叶片的一部分内表面对着第二瓣膜叶片的相应部分内表面,并使这些内表面部分相互连接。这些叶片的内表面部分连接在这些叶片的侧边缘。
本发明还有一方面涉及一种制造心瓣膜的方法,包括如下步骤:提供其每端都具有一个整体短小突出部分的第一和第二瓣膜叶片,及彼此相对地相互折叠这些短小突出部分以提供缝合的短小突出部分,该缝合的短小突出部分沿缝合短小突出部分线被连接到这些叶片上,从而使这些短小突出部分的自由端从该线向外延伸。
根据本发明的另一方面,一种假体瓣膜包括多个瓣膜叶片,这些瓣膜叶片由柔性材料制成,每个叶都有一个内表面和一个外表面,每个叶片都沿连接线连接另一个叶片,一个叶片的一部分内表面对着位于连接线的另一个叶片的一部分内表面,和位于每条连接线一端的缝合短小突出部分。该短小突出部分的几个自由端用于连接血管。
根据本发明的另一方面,假体瓣膜的几个叶片由马的心包构成。该心包例如固定在一种戊二醛溶液内。
为了概述本发明及在现有技术基础上获得的优点,上面已经描述了本发明的某些目的和优点。当然,可以理解,本发明的任何特定的实施例不必达到所有这些目的和优点。因此,例如,本领域的普通技术人员将认识到,本发明可以以一种获得或优化一个或一组这里所公开优点的方式实施,不必达到这里所公开或建议的其它目的或优点。
所有这些实施例都将包括在这里公开的本发明的范围内。对本领域的普通技术人员而言,从下面结合附图对最佳实施例的详细描述中,本发明的这些和其它实施例将变得更加清楚。
附图简述
图1是人心脏局部剖视图,示出位于先天主动脉瓣位置的管状心瓣膜的替代物。
图2示出本发明的假体管状心瓣膜,它安装在患者的主动脉内,其中有些部分被切除了,并且瓣膜处于打开状态。
图3示出图2的瓣膜处于关闭状态。
图4示出管状假体心瓣膜的另一个实施例,它具有本发明的特征,处于打开状态。
图5示出图4的瓣膜处于关闭状态。
图6示出类似图4中瓣膜的心瓣膜另一个实施例一部分的闭合剖视图。
图7是类似图4中心瓣膜的另一个实施例一部分的闭合剖视图。
图8是具有本发明特征的有凹坑边的(scalloped)管状假体心瓣膜的透视图。
图8A是图8中有凹坑边的管状假体心瓣膜的顶视图。
图9示出可以形成图8的瓣膜叶片的图案。
图10示出本发明的和具有环形缝合套箍(cuff)的管状假体心瓣膜的另一个实施例。
图11示出靠近下游端具有连接短小突出部分的管状假体主动脉心瓣膜的另一个实施例的透视图。
图12示出一个靠近下游端具有连接短小突出部分的管状假体心脏二尖瓣的一个实施例的透视图。
图13A-C示出图11中瓣膜的单个叶片的扁平图案。
图14A-B示出图12中瓣膜的单个叶片的扁平图案。
图15示出图13A-C中叶片的缝合结构,示出将相邻叶片固定在一起的缝合位置。
图16示出具有本发明特征的锥形主动脉心瓣膜的透视图。
图17示出处于部分关闭状态的锥形主动脉心瓣膜的另一个实施例。
图18A-C示出图17中心瓣膜叶的扁平图案。
图19示出图17中心瓣膜的缝合连接短小突出部分沿19-19线剖开后的剖视图。
图20示出具有本发明特征并具有倾斜缝合线的假体心脏二尖瓣的透视图。
图21A示出图20中心瓣膜后叶片的扁平图案。
图21B示出图20中心瓣膜前叶片的扁平图案。
图22示出将图21A和21B中的后和前叶片缝合在一起的初始步骤。
图23示出将图21A和21B中的后和前叶片缝合在一起的下一个步骤。
图24示出具有本发明特征的锥形假体心脏二尖瓣的透视图。
图25A示出图24中二尖瓣后叶片的扁平图案。
图25B示出图24中二尖瓣前叶片的扁平图案。
图26示出具有延伸到瓣膜出口端之外的缝合短小突出部分的心脏主动脉瓣又一个实施例的透视图。
图27示出从侧面观察的图26中的瓣膜,这样能够看见缝合短小突出部分区域内相邻叶片的缝合方式。
图28示出具有本发明的特征并具有适合使耐久性和血液动力学效率增大的缝合短小突出部分的管状假体心脏主动脉瓣另一个实施例的透视图。
图29示出用于构成图28的管状心脏主动脉瓣的一个叶片的扁平图案。
图30示出图29中缝合在一起直到缝合短小突出部分的两个相邻叶片。
图31是图30中叶片的顶视图。
图32是图30中叶片的顶视图,其中一个叶片的第二短小突出部分向后折叠。
图33是沿图32中线33-33剖开后的叶片的剖视图。
图34是图30中叶片的顶视图,其中叶片以必要的方式相互折叠,形成一个缝合短小突出部分。
图35示出图34中缝合在一起的缝合的短小突出部分。
图36示出图35中的叶片和缝合的短小突出部分的另一个视图。
图37示出围绕外边缘有接缝的图35的缝合短小突出部分的另一个视图。
图38示出适用于连接图35的缝合的短小突出部分的加强件。
图39示出安装在图35的缝合的短小突出部分上的图38中的加强件。
图40示出安装在图35的缝合的短小突出部分上的图38中的加强件。
图41示出图28中瓣膜的几个相邻叶片的另一个视图,示出安装在缝的合短小突出部分上的一个加强件。
最佳实施例的详细描述
图1示出正常人心脏50的剖视图。心脏50的左侧包括一个左心房52,一个位于左心室壁56和隔膜58之间的左心室54,一个主动脉瓣60和一个二尖瓣组件62。二尖瓣组件62的这些部件包括一个二尖瓣环带64;一个前叶66(有时叫做主动脉叶,因为它靠近主动脉区域);一个后叶68;两个乳头肌70和72,它们在其底部连接左心室壁56的内表面;及多个腱索74,这些腱索将二尖瓣叶片66和68连接到乳头肌70和72。在叶和乳头肌之间没有一一对应的腱连接;而是存在多个腱,每个乳头肌70和72的腱连接两个瓣膜叶片66和68。
主动脉80大体从左心室54向上延伸,主动脉瓣60位于主动脉80内,靠近左心室54。主动脉瓣60有三个尖头82或叶片。每个叶片82的几个部分在缝合点连接于主动脉壁84。主动脉80旁边示出的是一段管状组织90,它可以用于以下述方式替代主动脉瓣60。
心脏50的右侧包括一个右心房92,一个由右心室壁96和隔膜58包围的右心室94,及一个三尖瓣组件98。该三尖瓣组件98包括一个瓣膜环带100,三个叶片102,连接于右心室壁96内表面的乳头肌104,和多个腱索106,它们将三尖瓣叶片102连接到乳头肌104。
右心室94开向肺动脉(未示出),肺动脉使该室与肺相通。肺动脉瓣(未示出)位于肺动脉内,用于调节从右心室94流入肺动脉内的血液。
二尖瓣和三尖瓣叶片以及主动脉和肺动脉瓣尖头都是被动结构;它们本身不消耗任何能量,不完成任何积极的收缩功能。它们只用于响应瓣膜各侧上的不同压力而打开和关闭。
当左心室壁56舒张使该心室54扩大和吸入血液时,二尖瓣62打开(即叶片66和68分离),主动脉瓣尖头82彼此靠近,以关闭主动脉瓣60。富氧的血液流过二尖瓣62,充满扩张的心室54。靠近的主动脉瓣尖头82防止已经进入主动脉80的血液泄漏(反流)回到左心室内。一旦左心室54已经充满,那么左心室收缩,引起左心室内压力迅速上升。这引起二尖瓣62关闭(即叶66和68重新靠近),同时主动脉瓣60的尖头82打开,允许富氧的血液从左心室54注入主动脉80内。当左心室54收缩时,二尖瓣的腱索74防止二尖瓣叶片66和68脱垂到左心房52内。半月瓣(主动脉和肺)都没有相关的腱索或乳头肌。
三个叶片102,腱索106,和三尖瓣98的乳头肌104以类似二尖瓣62的方式起作用。肺动脉瓣被动地响应右心室的舒张和收缩,将脱氧后的血液输送到肺动脉内,然后再输送到肺内进行再次富氧。
总而言之,随着心室的舒张和扩张(心舒张),二尖瓣和三尖瓣打开,同时主动脉瓣和肺动脉瓣关闭。当心室收缩(心收缩)时,二尖瓣和三尖瓣关闭,主动脉瓣和肺动脉瓣打开。这样,血液被推动通过心脏两侧。
如上所述,有时需要用假体瓣膜替代先天心瓣膜。先天心瓣膜的摘除可以通过围绕瓣膜环带进行切割,并在房室瓣内切割相应的乳头肌和/或腱索,或者在半月瓣内切除瓣膜的缝合连接点。一旦摘除先天瓣膜,那么就通过缝合或其它连接方法将替代瓣膜的流入环带连接到先天瓣膜空出的瓣膜环带上。如下所述,替代瓣膜的下游部分优选连接到缝合连接点,或乳头肌和/或腱索上。
下面描述了很多管状假体心瓣膜的实施例。这些实施例说明和描述了本发明的各个方面。下面将描述主动脉瓣和二尖瓣的几个实施例,但是应当理解,所述涉及这些瓣膜的这些方面可以用于任何类型的心瓣膜。因此,即使半月瓣的如主动脉瓣和肺动脉瓣的叶片更适合称为“尖头”而不是“叶片”,该描述中也将半月瓣的尖头和房室瓣的叶片称为“叶片”。
图2和3示出图1中的管状假体心瓣膜90安装在患者的主动脉80内,其中为了示出瓣膜,主动脉壁84被部分剖开。如图所示,瓣膜90优选包括三个叶片110。每个叶片110由一种扁平的柔性生物组织或人工材料制成。这些叶片110沿缝合线112彼此连接,从而形成一个管状瓣膜90。该管状瓣膜在瓣膜的近端116具有一个流入环带(annulus)114,在瓣膜的远端120具有一个流出环带118。围绕该瓣膜流入环带114的一个环形缝线122将该瓣膜固定于主动脉壁84的流入环带114上,以使血液通过该瓣膜90而不是主动脉壁84和瓣膜90之间。这样,如图2所示,在收缩期间,叶片110被迫分开,使血液自由地通过管状瓣膜并如箭头所示方向流入主动脉80内。
瓣膜90在三个缝合连接点124连接主动脉壁84。优选不使用移植片固定模或支架将瓣膜固定于适当位置。缝合连接点124优选沿缝合线112布置,瓣膜90优选以连接缝线(suture)126连接主动脉壁84。
下面参见图3,在舒张期间,不同的压力促使血液如箭头所示朝心室流动。叶片110因此被相互拉到彼此靠近,从而密封该瓣膜,防止血液通过该瓣膜从主动脉80流入心室。将瓣膜90下游端连接到主动脉壁84的缝合连接点124防止叶片110脱垂。这能够使叶片110如所示的那样彼此接合,从而获得瓣膜的密闭。
在一个最佳实施例中,柔性材料包括马的心包,它已经被交联并固定在一种低浓度的缓冲戊二醛溶液内。申请人已经确定马的心包大约只有牛心包一半的厚度,并且就像牛心包一样强壮,它用于一些假体心瓣膜内。马心包厚度的减少导致叶片比前面使用的人工心瓣膜的叶更柔韧和更易于打开和关闭。该材料在制造瓣膜时还容易进行,因此能够提供更高的精度。
尽管马的心包用在所述实施例中,但是可以理解,很多材料包括生物和人造材料都可以使用。例如,牛、猪和袋鼠心包组织都可以适当地使用。此外,人造材料,如聚酯、特氟隆、纺织或编织织物等都能够被很好地利用。选用材料的总原则是越柔韧、越薄和强度越大,则材料越好。此外,材料尽可能不形成血栓是有利的。
使用期间,瓣膜90将在图2和3所示的打开和关闭状态之间重复循环。如所能够看见的那样,在关闭期间,叶片110通常折叠在缝合连接点124周围。由于叶片110在瓣膜使用期间将重复地折叠在缝合连接缝线126周围,因此这些缝线可以在关闭期间干扰瓣膜叶片110的正常和天然运动。此外,由于叶片110围绕缝线126的运动,缝合连接点124能够变成叶片的磨损和擦伤点。此外,由于缝合连接点124在舒张期间承受更大的作用力,缝线尤其是最远的缝线可能变成重要的应力集中点。上述状况可能显著降低缝合连接点124的耐久性。这些所关心的问题在下面的实施例中得到了关注和解决。
下面接着参见图4和5,管状心脏主动脉瓣130的另一个实施例以打开(图4)和关闭(图5)状态示出。心瓣膜130包括三个柔性叶片132,它们沿靠近它们侧边缘136的一条接缝(seam line)134缝合在一起。每个叶片132有一个内表面138,一个外表面140。相邻叶片的侧边缘136缝合在一起,从而使缝合在一起的叶片132的内表面138彼此面对,侧边缘136相对于瓣膜130的中心线Lc大体上径向朝外延伸。这种结构提供了很多优点。例如,这些叶片132自然部分地偏向关闭状态。这使瓣膜的关闭更容易和更自然。此外,尤其在靠近接缝134的区域,关闭更完全。此外,这些叶片132以一种能够使这些叶片边缘136紧密缝合在一起的方式缝合在一起,以便减少叶片之间的泄漏,使接缝强度和耐久性最大。此外,将瓣膜130连接到主动脉壁的缝合连接缝线142能够连接接缝134和叶132的侧边缘136之间的瓣膜折叠部分146。在这种结构,缝合连接缝线142实际上与这些叶片132的折叠部分隔离,从而使折叠叶不绕连接缝线142转动和相对于该缝线142移动。因此,接缝线142不妨碍叶片的运动或导致这些叶片132磨损和擦伤。
下面接着参见图6和7,心瓣膜130A,130B的附加实施例使用了缝合的短小突出部分150。这些缝合的短小突出部分150用于提供与折叠叶132隔离的缝合连接点,以便提高耐久性和在植入瓣膜时为外科手术放置缝合缝线提供一个容易看见的目标。
特别参见图6,位于接缝134和侧边缘136之间的相邻叶132的短小突出部分152稍微延伸到瓣膜130A的远端部分内。延伸部分152折叠,从而基本上与对应叶132的外表面140平行。这导致一对短小突出部分152延伸到瓣膜后并基本与打开的瓣膜相切。每个短小突出部分152通过一条缝线154连接主动脉壁。因此,至少要用两条缝线将缝合短小突出部分150连接到主动脉壁。这些缝线基本上与叶片的折叠部分隔离。此外,施加在缝合点的作用力分布在多条缝线上,因此减少了单个应力集中的显著性和冲击。
接着参见图7,专用缝合短小突出部分160的一个附加实施例包括位置靠近接缝134并从相邻叶片的远端向远处延伸的叶片132的隆起部分162。可以使用一条或多条缝合连接缝线154将隆起的缝合短小突出部分160连接到主动脉壁。该隆起的短小突出部分160为外科医生进行缝合确定了一个显而易见的目标,并且还有助于在瓣膜工作期间分配作用力。例如,在舒张期间,当不同的压力促使这些叶到达关闭状态时,隆起的短小突出部分160使缝合的缝线154定位于从每个叶片远端再次摘除的位置,因此进一步使缝合短小突出部分160与这些叶片132隔离,从而使缝合的缝线更少地影响瓣膜的关闭活动。此外,在关闭期间施加于瓣膜上的大部分作用力沿瓣膜远端集中。通过固定瓣膜远端的多条缝合的缝线,这些关闭力可以分布在多条缝线上。因此,单个缝线上的应力相对减少。
接着参见图8和9,其中描述了具有本发明特征的心脏管状主动脉瓣膜170的又一个实施例。瓣膜170具有有凹坑边的流入和流出叶边缘172,174。如图9所示,三个叶片173优选从单一一块扁平的柔性材料切下。侧边缘175优选在一条主接缝176处缝合在一起,形成一个大体为管状的瓣膜,如图8A所示。纵向接缝178被缝合,从而限定了这些叶片并帮助瓣膜关闭。
申请人通过实验已经发现形成凹坑边有助于瓣膜的关闭和血液动力学性能。如上所述,良好的血液动力学性能是心瓣膜所必需的。具有良好血液动力学性能的心瓣膜将允许血液平稳并有效地通过。另一方面,血液动力学问题导致血液的过度扰动和可能的集中合并。这可能导致各种问题,引人注目的是钙化,其中在心瓣膜上出现钙沉淀,最后损害瓣膜的功能。
在直边管状心瓣膜实施例的研制和测试期间,已经观察到在瓣膜关闭期间一些多余材料出现在瓣膜的流出端。该多余材料在瓣膜流出边缘引起过度的折叠和褶皱。直边管状实施例的流入边缘在生理性关闭测试期间还检查和观察到在靠近流入环带的叶边缘出现了折叠。此外,使流入边缘成凹坑有助于更好地适应先天瓣膜空出的环带内的假体瓣膜。
通过连续的研制和测试,申请人已经确定使每个叶片的流入和流出边缘172和174都成凹坑有助于增加瓣膜的血液动力学性能和减少褶皱和折叠,这些褶皱和折叠对瓣膜的耐久性和关闭能力有长期的副作用。
正如能够从图8和9中看到的一样,靠近流入环带176的凹坑能够使叶片中央部分就近延伸出毗邻接缝178的叶片近端之外。每个叶片的近端172在毗邻接缝178的点处和该叶片中央之间的距离Dp已经通过测试已被确定,它优选约为瓣膜总体直径的15%-25%,更优选约为瓣膜直径的20%。凹坑优选具有平缓的曲线。
在瓣膜的远端174,每个瓣膜的中央部分优选距离毗邻接缝178的叶片的远端近点距离为Dd。该距离Dd已经通过实验确定,优选约为瓣膜总体直径的8%-20%,更优选约为瓣膜直径的15%-17%。至于流入环带,凹坑优选是平缓的曲线。
在瓣膜重复打开和关闭期间以及在血液通过瓣膜和主动脉的脉冲流动期间,流入环带保持很大的作用力。因此,本发明的另一个实施例提供了一种在流入环带182具有加强件的管状瓣膜180。接着参见图10,环形缝合套箍184可以设置在流入环带182处,从而在流入环带182处提供加强件。在一个最佳实施例中,缝合套箍184包括一种纺织或编织织物材料,优选为一种聚酯材料,它被缝合或以其它方式连接到瓣膜的流入环带182上。纺织织物可以使来自主动脉的纤维组织生长在加强材料内和加强材料周围,进一步将该套箍和瓣膜固定于主动脉壁上,更好地建立流入环带182和主动脉壁之间的密封。此外,由于组织生长在纺织材料内和纺织材料周围,天然细胞位于血流和人造材料之间,使人造织物材料和血流有效地隔离。由于通过该瓣膜的血流借助该组织与该材料分离,因此减少甚至消除了该材料的血栓形成性。通常排列于血管系统整个内表面的一薄层内皮细胞最好位于在环带182部分。
尽管所示缝合套箍184使用在一个简单的管状瓣膜180内,但是可以理解,这样一种纺织或编织缝合套箍能够用于上述或下述任何实施例中,包括凹坑边实施例中。此外,其它适当的材料如心包也能够用于通过缝合套箍提供额外的加强。
接着参见图11和12,其中示出了主动脉190(图11)和二尖瓣192(图12)管状假体心瓣膜的实施例。在这些实施例中,缝合的连接短小突出部分196沿邻近瓣膜远端/流出端200的接缝198设置。所示的连接短小突出部分196大体为三角形的“狗耳”形。构造这些瓣膜的方式将在下面进行讨论并示于图13-15中。
图11的主动脉瓣190通过连接三个叶片202而构造成。接下去参见图13A-C,这些叶202优选由一块扁平的柔性材料如上述的马心包切割而成。每个叶片的边缘部分204朝外延伸,毗邻叶片的远端200,大体形成从叶片202主体延伸的三角形短小突出部分206。
图15示出构成瓣膜190的缝合图案。对于图4和5所述实施例,相邻的叶片202沿它们的侧边缘204缝合在一起,使它们的内表面212彼此面对。因此,相邻叶202的内表面212彼此接合,每个叶202的侧边缘204从瓣膜190的中心线Lc朝外径向延伸。
将相邻叶片缝合在一起的最佳方法包括步骤:首先用缝纫针制成常规三联环,然后形成一系列针脚(stitches)214,优选是在钮孔型针脚之后为锁定钮结,它起始于瓣膜190的流入端216,并沿毗邻叶片边缘(见图15)的大体直的接缝L朝瓣膜的流出端200延伸。沿边缘204的针脚214优选距离这些边缘大约1毫米,并间隔开1-1/2毫米。优选地,一种双环或另一种类型的锁定的针脚用于锁定每一个针脚。采用钮孔针脚后跟一个锁定结,即使在接缝被切开或断开时也能够保持整个接缝的整体性。
当缝合到远端短小突出部分206的近端220时,缝合结束,接着是接缝L,和连续的针脚214沿短小突出部分206外边缘被打结。当缝合已经结束于叶片的远端220时,连续的针脚朝接缝L方向沿远端边缘打结,直到一针脚在大体毗邻接缝L和叶片远端交叉的位置处被打结。这样,相邻的叶片202被紧紧地相互连接在一起,并形成一个从叶片202的主体210分离的缝合的连接短小突出部分196。
缝合的连接短小突出部分196适合接收缝合连接缝线(未示出),将瓣膜连接到缝合连接点。图11-15示出的“狗耳”缝合连接短小突出部分包括相邻叶片的重叠层。这在远端缝合连接点提供了加强件,因此提高了假体瓣膜的长期耐久性。
在所述实施例中,打结的缝合不是沿叶片202最远端部分内的接缝L延伸。这减少了沿接缝L的缝合将妨碍叶片关闭的可能性;因此,能够减少瓣膜重复打开和关闭期间锁定针脚周围叶片折叠的应力集中和可能的摩擦和磨损。
下面参见图12和14,对于二尖瓣192,前叶片224(图14A)通常小于后片叶226(图14B)。在所述实施例中,前叶片224的宽度Wa通常约为后叶片宽度Wp的一半。相邻的叶片以上述方式缝合在一起,导致2-叶片二尖瓣192如图12所示那样具有狗耳缝合连接短小突出部分196。
接着参见图16,具有本发明特征的假体心瓣膜230的另一个实施例包括一个管状瓣膜,其中瓣膜230从流入环带232到流出环带234是锥形的。如所示的那样,流出环带234的直径Do小于流入环带232的直径Di。该实施例作为一种解决方案已经被申请人在瓣膜研制和测试期间证实。此外,在主动脉瓣内,缝合连接点位于主动脉内直径稍微小于瓣膜环带直径的部分。
申请人在测试基本为圆柱形的管状瓣膜时发现,在瓣膜关闭期间,瓣膜叶片远端倾向于有些折叠,因此扰乱了相邻叶片的平滑连接,对瓣膜的密封产生不利影响。申请人注意到大体为圆形的流出环带234的周长为πD,其中D代表瓣膜直径。当瓣膜关闭时,如图3和图5所示,每个叶片折叠,与两个相邻的叶片接合,从而使这些叶片的远边缘从瓣膜边缘到瓣膜的纵向中央Lc都相接合。因此,相邻叶片每个远边缘共有接合长度大约等于瓣膜的半径R。由于每个叶片有两个接合长度,有三个叶片,因此,总的线性接合长度大约为瓣膜半径的6倍,或6R,它等于直径的三倍(3D)。由于πD大于3D,因此瓣膜的远边缘拥有的材料比叶片在关闭状态彼此接合时能够容纳的材料更多。因此,多余材料往往在关闭期间产生折叠和褶皱。
业已发现使管状瓣膜为锥形由于在瓣膜叶片和主动脉壁之间提供了额外的空间而解决了该令人关注的问题。管状心瓣膜230的流入环带232的尺寸优选基本适合用主动脉壁关闭。在一个非锥形的直管状瓣膜内,流出环带因此基本上用主动脉壁关闭,当打开时在叶片和壁之间只有很少或几乎没有空间。但是,在锥形瓣膜内,流出环带234的直径Do稍微小于流入环带的直径Di,在流出端的叶片和主动脉壁之间形成一个空间。在瓣膜关闭期间,当叶折叠彼此接合时,瓣膜的接缝径向朝外移动一点距离,进入该空间,从而增加了相邻叶片之间的接合长度,与瓣膜远端流出环带234的整个周长(πD)相配合。因此,使瓣膜成为锥形减少了折叠和可能由于限制叶片远端能够工作的空间所造成的其它断裂。
当然,当使瓣膜成为锥形时更需要考虑的是通过限制流通过的血液阻碍瓣膜的血液动力学性能。因此,使瓣膜成为锥形的缺陷大于其必要性或有利性。通过测试和分析,申请人已经确定这些瓣膜的锥度优选不大于流入直径Di的10%;更优选使锥度约为1-7%,最优选约为流入直径Di的5%。
图17-19示出锥形主动脉瓣240的另一个实施例。该瓣在其远端244具有大体为长方形的缝合安装短小突出部分242。图18A-C中的每一幅图都描绘了已经从薄而扁平的柔性材料上切割下的叶片246,它们用于构造成图17的瓣膜240。这些叶片246优选彼此基本相同,每个叶片都包括一个具有近端252、远端254和几个侧边缘256的主体250。侧边缘256从叶片主体250的近端252朝远端254向内倾斜,从而使每个叶片246的近端宽度Wp优选大于每个叶片的远端宽度Wd。大体为长方形的短小突出部分258靠近每个叶246的远端254。
下面接着参见图19,当相邻的叶片246缝合在一起时,每个短小突出部分258折叠,折叠在自身上,从而使相邻叶片的短小突出部分的侧边缘260相互接近。这些短小突出部分258接着沿它们的侧边缘使用多根缝线(stitches)262缝合在一起。当这些短小突出部分258如所示的那样缝合在一起时,它们形成了一个基本与瓣膜240的远端流出边缘244相切的双层缝合短小突出部分242。一旦缝合短小突出部分242形成,那么缝线262包围其外边缘264,以便帮助短小突出部分保持其折叠形状。按照这种方式构造缝合短小突出部分242,由于其大体为正切的结构,提供了一种更强的双层短小突出部分,这些突出部分基本适合用主动脉壁关闭,并提供了一个大体与折叠瓣膜叶片隔离的缝合连接点。
图17也示出流入环带加强结构266的另一个实施例。在所示的实施例中,流入环带268处的叶片材料折叠于自身上一小段距离,并被适当缝合。优选地,该材料折叠于自身上的距离约为1-5毫米,更优选为约2-3毫米。在流入环带268处将叶材料折叠于自身上加强了该环带,并提供了一个加强层266,加强了主动脉壁和流入环带268之间的连接。折叠加强部分266可以用于替代或附加于图10中的织物加强件184。
下面接着参见图20-23,一个二尖瓣270也使用倾斜的接缝结构。通过测试申请人已经认识到二尖瓣倾向于沿不必彼此平行的线折叠。图20所示的实施例使用了一种倾斜接缝结构272。图21A和21B分别描述了图20中瓣270的后瓣膜叶片和前瓣膜叶片274和276。后叶片274的流入边缘280的宽度Wpi约为前叶片276流入边缘282宽度Wai的两倍。但是,如附图所示,两个叶片274和276流出边缘284和286的宽度Wo基本相同。
下面接着参见图22和23,各个叶片274和276的侧边缘290首先对准,接着用连续的锁定针脚292从流入边缘280和282开始朝流出边缘284和286及绕上所述短小突出部分294缝合在一起。但是可以理解,其它实施例可以采用不连续的缝合,或可以采用从流出边缘到流入边缘的连续缝合。
接着参见图24和25,其中提供了具有本发明特征的一种假体二尖瓣300的另一个实施例。为了利用了图16-19所述锥形瓣膜的各方面的优点,该二尖瓣300从其流入边缘302到其流出边缘304是锥形的。
接着参见图21A和B及25A和B,在上述两个二尖瓣实施例中,后叶片274,274A的流出边缘284,284A的宽度Wo基本与前叶片276,276A流出边缘286,286A的宽度Wo相同。这利用了申请人的发现和观察,当瓣膜叶片流出边缘的宽度Wo基本相等时,观察到两叶片瓣膜更好地关闭。但是,在两个实施例中,接缝272,306变化,从而使瓣270和300按照要求的方式折叠。
接着参见图26和27,其中提供了假体心脏主动脉瓣的另一个实施例。该瓣膜包括三个凹坑边叶片312,这些叶片沿它们的侧边缘314缝合在一起,并具有大体与瓣膜流出端318相切的长方形缝合连接短小突出部分316。相邻叶片312通过一系列从叶312流入边缘322朝流出边缘324延伸的琐定针脚320彼此连接,这些针脚终止于短小突出部分242的近端326。缝合的短小突出部分316的构造方式与图17-19的短小突出部分的构造方式相同;但是,缝合的短小突出部分316延伸到相应叶片312远端324之外。折叠的缝合短小突出部分316优选缝合在一起,以便提供一种使缝合连接更牢固的加强件。
如图27所示,锁定缝线320不是沿空间328内的缝线L在短小突出部分316近端326和叶主体远端324之间延伸。此外,叶312沿该部分328松散地缝合。
在另一个实施例中,在瓣膜流出端和每个缝合短小突出部分近边缘之间的空间328内沿缝线L没有提供缝合。在缝合短小突出部分316近边缘326和瓣膜310流出端318之间的空间328内,沿缝线L终止锁定缝线320和只提供小缝线或根本不提供缝线减少了穿过叶材料的孔数。其中每个孔都削弱了叶材料的强度。在远端部分内保持叶材料的连续性提高了瓣膜远端部分的耐久性。
形成缝合连接短小突出部分316,使它延伸到叶片324远端之外,能更好地分配瓣膜工作产生的应力。如上所述,关闭瓣膜310的大部分压力集中在瓣膜310流出端318。瓣膜310远端的缝合缝线承载该关闭力。在几个不隆起的缝合短小突出部分,或在没有短小突出部分的瓣膜结构中,最远的缝线承载绝大部分力。这种结构能够降低最远缝线周围的叶片的耐久性。隆起的短小突出部分316能够利用多条缝线将缝合的短小突出部分316固定在主动脉壁上。集中在瓣膜叶片312流出端324上的关闭力将被分布在这些缝线上,它们位于流出端324远端的短小突出部分316的隆起部分上。此外,缝合缝线与折叠叶片312隔开,不干扰叶的工作。
可以理解,在半月瓣和房室瓣内可以使用各种类型和形状的缝合的连接短小突出部分。在半月瓣例如主动脉瓣中,缝合的短小突出部分使瓣膜与主动脉壁连接。在房室瓣如二尖瓣中,缝合的短小突出部分使瓣膜与腱索和/或乳头肌连接。房室瓣的这些缝合的短小突出部分能够以优选适合这种连接的方式成形。
下面参见图28-41,其中示出了心脏管状主动脉瓣的另一个实施例。首先参见图28和29,心脏主动脉瓣330包括从一块平而柔韧的材料上按照图29中的叶片图案裁下的三个叶片332。如图所示,每个叶片332在其近端和远端334和336做成凹坑边。远端短小突出部分340,342从每个叶主体346侧边缘344朝外延伸。短小突出部分340,342基本上都是长方形的,远远地延伸到主体346远端336之外。每个短小突出部分340,342的一个内边缘348优选对准或仅从主体346外侧边缘344朝外对准。
每个短小突出部分340,342通过颈部350与叶片主体346连通。过渡边缘352,354使每个短小突出部分的内边缘348与叶片332的远端336连接,每个短小突出部分340,342的一个近端边缘356与叶片的侧边缘344连接。过渡部分352,354优选是弯曲的,从而避免过渡点产生应力集中。
第二短小突出部分342内形成有一条细长槽360。该槽360从短小突出部分342的近边缘356远远地延伸到叶片主体346最远边缘远端点。槽360的最远端优选有倒角,以避免应力集中。槽360的纵向中心线CL优选位于从短小突出部分342内边缘348到该短小突出部分外边缘362之间距离的约2/3处。
参见图30,相邻叶片332通过使叶片的外边缘344合在一起而连接,从而使叶片332内表面364彼此接合。侧边缘344使用一系列锁定的针加366沿毗邻每个侧边缘344的一条折叠线Lf缝合在一起,这些针脚位于叶332近端334和远端336之间。侧折叠部分368毗邻侧边缘344。当叶片332沿侧边缘344缝合在一起时,希望折叠部分368大体沿该折叠线Lf折叠。在所示实施例中,每个叶片332的远端334在侧折叠部分368内不是凹坑边,从而能够更好地适应该区域内的缝线。
缝合在达到短小突出部分340,342近端边缘356之前结束,最后的缝线位于近端过渡边缘354近端。接着沿折叠线折叠短小突出部分340,342,从而使各个叶片332的外表面369重叠,如图30和31所示。如图所示,相邻的第一和第二短小突出部分340,342折叠在它们的颈部360内。这些短小突出部分340,342再次折叠和彼此连接,形成适合避免应力集中并使耐久性增加的缝合连接短小突出部分370。缝合的短小突出部分370的构造方式在下面进行描述。
下面参见图32和33,其中第二短小突出部分342向后弯,使槽360位于两个短小突出部分的折叠颈部350上。图34示出接着折叠第一短小突出部分340,使它大体靠近第二短小突出部分342。一旦这些短小突出部分已经相互折叠,那么能够在短小突出部分折叠内进行小的调整,直到总缝合短小突出部分370大体成为相邻短小突出部分332彼此靠近折叠的颈部350中沿线的中心。槽360的尺寸优选能够使第二短小突出部分342基本围绕但不接触叶片颈部350,从而使第二短小突出部分342不影响叶片工作。
下面参见图35-37,一旦短小突出部分340,342彼此适当对准并折叠形成一个适当的缝合连接短小突出部分370,那么通过这些短小突出部分340,342形成一条倒U形线,使这些短小突出部分相互连接。如图36所示,缝合优选基本平行于槽360,但与槽360间隔开,从而使第一和第二短小突出部分340,342牢固地缝合在一起,但是短小突出部分颈部350内没有缝合。
为了进一步将这些短小突出部分固定在一起,提供了一种清洁、紧凑的边缘结构,边缘缝合374绕每个缝合的连接短小突出部分370周边设置,如图37所示。
如上所述,当工作期间不同的压力引起瓣膜关闭时,瓣膜的最远端部分承受绝大部分关闭力。由于相邻叶片332不是在颈部350内缝合在一起,它是瓣膜叶片332的最远端部分,因此颈部内的叶片材料是连续的,不存在导致瓣膜耐久性降低的应力集中点(例如适合缝合线的通孔)。此外,在远端部分350内沿折叠线Lf没有缝线,在工作期间不影响瓣膜330的打开和关闭。此外,缝合的连接短小突出部分370的折叠结构能够使短小突出部分容纳多根缝线,从而分配关闭力而不影响瓣膜工作。
还有一个实施例也提供了缝合短小突出部分382的加强件380。下面参见图38和39,一种纺织织物加强件380有一个槽部382。该槽部382的尺寸和设置应该能够适合装在叶片332的颈部350上,该加强件380能够被折叠在缝合短小突出部分370远端边缘384上。在被折叠于该缝合短小突出部分370上之后,该加强件380被缝合在该短小突出部分370上,如图40所示,其中在加强件380折叠就位之后,边缘缝合线374位于短小突出部分370上。
下面参见图41,加强槽382的尺寸优选为能够在织物380和叶片332的颈部350之间提供一个空间,从而使该加强件380在叶片332打开和关闭时基本不接触颈部350。这减少了摩擦并进一步避免了应力集中。
在缝合的短小突出部分被适当地缝合在主动脉壁上之后,纤维组织将在加强层的纺织织物内或周围生长,进一步固定缝合的短小突出部分。此外,内皮细胞能够使血流与纺织织物材料隔离。因此减少了形成血栓性和提高了耐久性。
所示缝合的短小连接件基本为长方形结构。但是可以理解,为了适应其它瓣膜设置和类型如房室瓣,也可以提供各种形状和尺寸的折叠缝合连短小突出部分,其中缝合的短小突出部分连接腱索和乳头肌。
为了提高构造瓣膜时的一致性和质量,每个叶的形状优选基本相同。可以使用各种切割介质和方法如剃刀、冲刀、激光或流体和/或粒子喷射重复和精确地切割叶片。
马心包是具有三层的层状结构,其中包括内脏、浆膜和体壁层。申请人已经发现使用接触型刀具如剃刀、冲刀切割马心包有沿切割边缘分成一层或多层的趋势。这是因为接触型切割刀具在叶材料上施加较大的力。分层能够破坏瓣膜的工作,大大损害瓣膜的耐久性。例如,血液能够进入所分层之间,引起尖头血肿,或由于扰动增加而导致瓣膜钙化。因此,希望在构造瓣膜时减少或消除心包层的分层现象。
在一个最佳实施例中,非接触型刀具如脉冲持续时间比马心包热弛豫点短的二氧化碳激光用于从马心包平片上切下单个的叶片。该激光器的脉冲持续时间和功率选为能够使心包层基本沿切割边缘集中在一起,但是并不会被过度烧损以致损坏叶片或使其变形,或产生过度钙化。由于多层沿它们的边缘熔融在一起,因此在该方案中通过使用激光器解决了分层问题。
一种脉冲激光器也可以很好地用于切割加强件的纺织织物。这种激光器切割能够在织物上形成卷边或小珠,从而使织物端部不被磨损。通过消除磨损提高了耐久性,减少了血栓形成性。
改变特定激光器的参数,例如脉冲功率,切割速度,和每英寸的脉冲数,能够使操作者选择很多方案,这些方案将给心包层和织物加强件提供切割和熔融。
在一个最佳实施例中,绘图激光切割机例如可以从Universal LaserSystems of Scottsdale,Arizona购买的M-series激光器用于精确地从马心包平层切割出叶片。该绘图仪优选由计算机控制,以便提供精度和重复性。
尽管在特定的最优选实施例和实例的上下文中已经说明了本发明,但是本领域的普通技术人员可以理解,在本发明公开的特定实施例之外也可以有其它实施例,和/或本发明的使用,和各种改进和等效替换。此外,虽然已经详细示出和描述了很多本发明的改型,但是本领域的普通技术人员在本说明书的基础上可以很容易理解本发明范围内的其它改型。希望对所公开的这些实施例的多个特征和方面进行各种组合或变形,并且它们也落入本发明的保护范围内。因此,可以理解,所公开实施例的各种特征和方面都可以相互组合或替代,以便形成本发明的改进模式。因此,这里公开的本发明的范围并非由所公开的特定实施例限制,而应该由下面的权利要求限定。
Claims (48)
1.一种无移植片固定模的假体心瓣膜包括:
多个薄的柔性叶片,每个柔性叶片具有一个内表面,一个外表面,一个流入边缘,一个流出边缘和几个侧边缘,多个叶片沿其侧边缘的至少一部分缝合在一起,从而形成一个具有流入端和流出端的大体为管状的瓣膜结构,相邻的叶片设置成使它们的侧边缘基本对齐,几个叶片的内表面靠近这些侧边缘彼此接合,
其中该瓣膜结构可在关闭位置和打开位置之间活动,在关闭位置相邻叶片的流出边缘相互接合,在打开位置相邻叶片的流出边缘除了沿这些侧边缘之外相互分开,叶片侧边缘的缝合部分将叶片朝着部分关闭位置偏离。
2.如权利要求1的心瓣膜,其中对齐的叶片侧边缘基本上从大体为管状的瓣膜结构朝向延伸。
3.如权利要求1的心瓣膜,其中每个叶片包括一个邻近叶流出边缘的短小突出部分。
4.如权利要求3的心瓣膜,其中每个短小突出部分延伸到相应叶片的流出边缘之外。
5.如权利要求3的心瓣膜,其中这些短小突出部分设置成靠近至少一个叶片侧边缘。
6.如权利要求5的心瓣膜,其中一个短小突出部分靠近每个叶片的侧边缘形成。
7.如权利要求6的心瓣膜,其中相邻叶片的短小突出部分彼此连接形成缝合的连接短小突出部分。
8.如权利要求7的心瓣膜,其中连接的短小突出部分至少部分地彼此折叠。
9.如权利要求7的心瓣膜,其中还包括对缝合的连接短小突出部分的加强件。
10.如权利要求7的心瓣膜,其中缝合的短小突出部分远远地延伸到管状瓣膜结构流出端之外。
11.如权利要求6的心瓣膜,其中当瓣结构处于打开状态时,每个缝合的短小突出部分基本位于与管状瓣膜结构相切的平面内。
12.如权利要求1的心瓣膜,其中每个叶片基本是相同的。
13.如权利要求1的心瓣膜,其中包括一个第一叶片和一个第二叶片,第一叶片流入边缘的宽度大于第二叶片流入边缘的宽度。
14.如权利要求13的心瓣膜,其中第一叶片流出边缘的宽度大体上与第二叶片流出边缘的宽度相同。
15.如权利要求1的心瓣膜,其中还包括一个连接于瓣膜流入端的织物加强件。
16.一种无移植片固定模的半月心瓣膜,包括:
三个薄的柔性叶片,每个柔性叶片具有一个内表面,一个外表面,一个流入边缘,一个流出边缘,几个侧边缘和几个向外延伸到侧边缘之外并靠近流出边缘的短小突出部分,这些叶片沿它们的侧边缘相互连接,从而形成一个具有流入端和流出端的大体为管状的瓣膜结构;
其中相邻叶片的短小突出部分相互接合,形成缝合的连接短小突出部分,每个缝合的连接短小突出部分的至少一部分邻接相邻叶的外表面。
17.如权利要求16的半月心瓣膜,其中该三个叶片彼此基本相同。
18.如权利要求16的半月心瓣膜,其中相邻的叶片设置成使它们的侧边缘基本对齐,叶片内表面靠近侧边缘相互连接,多条缝线沿一条邻近对齐的侧边缘的线设置。
19.如权利要求18的半月心瓣膜,其中邻近该叶片流出边缘的一部分线没有缝线。
20.如权利要求16的半月心瓣膜,其中相邻该叶片的短小突出部分彼此重叠,从而使缝合的短小突出部分具有多层。
21.如权利要求20的半月心瓣膜,其中还包括一个连接于缝合的连接短小突出部分的织物加强件。
22.如权利要求16的半月心瓣膜,其中瓣膜结构流入端的直径大于瓣膜结构流出端的直径。
23.如权利要求16的半月心瓣膜,其中每个叶片流入边缘和流出边缘基本为凹坑边形。
24.如权利要求23的半月心瓣膜,其中每个叶片流入边缘的中央部分延伸一段距离,靠近侧边缘汇合流入边缘的位置。
25.如权利要求24的半月心瓣膜,其中每个叶片流出边缘的中央部分延伸一段距离,远离侧边缘汇合流出边缘的位置。
26.一种无移植片固定模的心瓣膜,包括:
具有一个叶片主体的第一叶片,该叶片主体具有一个内表面,一个外表面,一个近端,一个远端,一个第一侧边缘,和一个邻近该远端并从该第一侧边缘延伸的第一短小突出部分;及
具有一个叶片主体的第二叶,该叶片主体具有一个内表面,一个外表面,一个近端,一个远端,一个第二侧边缘,和一个邻近该远端并从该第二侧边缘延伸的第二短小突出部分,该第二短小突出部分具有一个纵向槽并通过第二颈部连接于第二叶片主体;
第一叶片的第一侧边缘和第二叶片的第二侧边缘基本上相互对齐并相互连接,第一叶片和第二叶片的内表面靠近对齐的侧边缘相互接合;及
其中第二短小突出部分折叠,从而使第一和第二颈部通过第二短小突出部分的纵向槽延伸。
27.如权利要求26的心瓣膜,其中第一短小突出部分折叠在第二短小突出部分上。
28.如权利要求26的心瓣膜,其中第一和第二颈部不缝合。
29.如权利要求26的心瓣膜,其中第一和第二短小突出部分缝合在一起,形成一个缝合的短小突出部分。
30.如权利要求29的心瓣膜,其中缝合的连接短小突出部分适合连接于血管内壁。
31.如权利要求26的心瓣膜,其中每个叶片的短小突出部分、颈部和主体是一体成型的。
32.如权利要求26的心瓣膜,其中叶片的近端和远端是凹坑形的。
33.一种制造无移植片固定模的假体心瓣膜的方法,包括如下步骤:
提供一段基本扁平的柔性材料;
从该扁平材料上切割出多个叶片,使每个叶片都有一个内表面,一个外表面,一个近端,一个远端,几个侧边缘,和几个邻近该远端并从该侧边缘延伸的短小突出部分;
对齐相邻叶片的侧边缘在一起,以便相邻叶片的内表面靠近这些侧边缘相互接合;及
将对齐的侧边缘缝合在一起,形成一个具有一个流入端和一个流出端的大体为管状的瓣膜结构。
34.如权利要求33的方法,其中提供一段基本扁平的柔性材料包括提供一段心包并固定该心包。
35.如权利要求34的方法,其中该材料是马心包。
36.如权利要求33的方法,其中使用非接触型切割装置切割出多个叶片。
37.如权利要求37的方法,其中使用激光器切割出多个叶片。
38.如权利要求33的方法,其中还包括折叠叶片的短小突出部分,从而形成一个缝合的短小突出部分。
39.一种制造假体心瓣膜的方法,包括如下步骤:
提供第一瓣膜叶片和第二瓣膜叶片,这些叶彼此分开成型;
将第一瓣膜叶片的一部分内表面对着第二瓣膜叶片相应部分的内表面,及
使这些内表面部分相互连接。
40.如权利要求39的方法,其中叶片的内表面部分连接在叶的侧边缘。
41.如权利要求39的方法,其中还包括利用马心包形成瓣膜叶片。
42.一种制造心瓣膜的方法,包括如下步骤:
提供端部具有一个整体短小突出部分的第一和第二瓣膜叶片;及
相对于彼此折叠这些短小突出部分,形成一个缝合的短小突出部分,该缝合的短小突出部分沿缝合短小突出部分线连接于这些叶片上,从而使这些短小突出部分的自由端从该线向外延伸。
43.如权利要求42的方法,其中还包括将瓣膜叶片侧边缘沿与缝合短小突出部分线共同延伸的连接线彼此连接。
44.一种假体瓣,包括:
多个瓣膜叶片,这些瓣膜叶片由柔性材料制成,每个叶片都有一个内表面和一个外表面,每个叶片沿连接线连接于另一个叶片,一个叶片的一部分内表面面对位于连接线的另一个叶片的一部分内表面;及
位于每条连接线一端的缝合的短小突出部分,所述短小突出部分的自由端构造成用于连接血管。
45.如权利要求44的瓣膜,其中缝合的短小突出部分由一种柔性材料构成。
46.如权利要求44的瓣膜,其中缝合的短小突出部分与瓣膜叶片成一个整体。
47.如权利要求44的瓣膜,其中这些叶片由心包组织构成。
48.如权利要求47的瓣膜,其中这些叶片由马心包构成。
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- 2001-01-29 HU HU0204398A patent/HUP0204398A2/hu unknown
- 2001-01-29 BR BR0107897-6A patent/BR0107897A/pt not_active Application Discontinuation
- 2001-01-29 AT AT01908738T patent/ATE399513T1/de not_active IP Right Cessation
- 2001-01-29 DK DK01908738T patent/DK1251804T3/da active
- 2001-01-29 NZ NZ520462A patent/NZ520462A/en not_active IP Right Cessation
- 2001-01-29 AU AU36579/01A patent/AU780931B2/en not_active Expired
- 2001-01-29 PL PL356923A patent/PL199785B1/pl unknown
- 2001-01-29 EP EP01908738A patent/EP1251804B1/en not_active Expired - Lifetime
- 2001-01-29 KR KR1020027009730A patent/KR20020082217A/ko not_active Application Discontinuation
- 2001-01-29 JP JP2001555604A patent/JP2003521314A/ja active Pending
- 2001-01-29 CA CA2398281A patent/CA2398281C/en not_active Expired - Lifetime
- 2001-01-29 WO PCT/US2001/002911 patent/WO2001054624A1/en active IP Right Grant
- 2001-01-29 SK SK1102-2002A patent/SK11022002A3/sk unknown
- 2001-01-29 ES ES01908738T patent/ES2307590T3/es not_active Expired - Lifetime
- 2001-01-29 MX MXPA02007253A patent/MXPA02007253A/es not_active Application Discontinuation
- 2001-01-29 CZ CZ20022574A patent/CZ20022574A3/cs unknown
- 2001-01-29 CN CN01805244A patent/CN1404376A/zh active Pending
- 2001-01-29 DE DE60134625T patent/DE60134625D1/de not_active Expired - Lifetime
- 2001-01-29 US US09/772,526 patent/US6682559B2/en not_active Expired - Lifetime
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2002
- 2002-07-24 NO NO20023538A patent/NO20023538L/no not_active Application Discontinuation
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2004
- 2004-01-05 US US10/751,549 patent/US6911043B2/en not_active Expired - Lifetime
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CN100405991C (zh) * | 2005-07-08 | 2008-07-30 | 北京佰仁医疗科技有限公司 | 心脏流出道带瓣补片 |
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CN103391756B (zh) * | 2010-12-14 | 2016-06-01 | 科利柏心脏瓣膜有限责任公司 | 包括具有整合瓣叶的折叠膜尖瓣的可经皮输送的心脏瓣膜 |
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CN105073068A (zh) * | 2013-03-12 | 2015-11-18 | 爱德华兹生命科学公司 | 可快速部署的外科心脏瓣膜 |
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CN103239301A (zh) * | 2013-04-23 | 2013-08-14 | 金仕生物科技(常熟)有限公司 | 瓣膜瓣叶裁选设备及裁选方法 |
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CN111182857A (zh) * | 2017-08-22 | 2020-05-19 | 基因创新医疗科技股份有限公司 | 可折叠单向瓣膜 |
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CN109172041A (zh) * | 2018-11-21 | 2019-01-11 | 杭州嘉和众邦生物科技有限公司 | 一种带瓣管道及其制备方法 |
CN109172041B (zh) * | 2018-11-21 | 2024-03-12 | 杭州创心医学科技有限公司 | 一种带瓣管道及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
DE60134625D1 (de) | 2008-08-14 |
NZ520462A (en) | 2004-08-27 |
HUP0204398A2 (en) | 2003-03-28 |
JP2003521314A (ja) | 2003-07-15 |
NO20023538D0 (no) | 2002-07-24 |
EP1251804B1 (en) | 2008-07-02 |
DK1251804T3 (da) | 2008-11-03 |
AU780931B2 (en) | 2005-04-28 |
CA2398281A1 (en) | 2001-08-02 |
MXPA02007253A (es) | 2003-09-22 |
EP1251804A1 (en) | 2002-10-30 |
SK11022002A3 (sk) | 2003-03-04 |
NO20023538L (no) | 2002-09-26 |
AU3657901A (en) | 2001-08-07 |
WO2001054624A1 (en) | 2001-08-02 |
BR0107897A (pt) | 2002-11-05 |
US20040138742A1 (en) | 2004-07-15 |
US7037333B2 (en) | 2006-05-02 |
US6911043B2 (en) | 2005-06-28 |
US20020052651A1 (en) | 2002-05-02 |
PL356923A1 (en) | 2004-07-12 |
PL199785B1 (pl) | 2008-10-31 |
CA2398281C (en) | 2011-01-04 |
US6682559B2 (en) | 2004-01-27 |
KR20020082217A (ko) | 2002-10-30 |
ATE399513T1 (de) | 2008-07-15 |
ES2307590T3 (es) | 2008-12-01 |
US20040138743A1 (en) | 2004-07-15 |
CZ20022574A3 (cs) | 2003-01-15 |
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