CN101309654B - 经心尖心脏瓣膜输送系统 - Google Patents

经心尖心脏瓣膜输送系统 Download PDF

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CN101309654B
CN101309654B CN200680042808XA CN200680042808A CN101309654B CN 101309654 B CN101309654 B CN 101309654B CN 200680042808X A CN200680042808X A CN 200680042808XA CN 200680042808 A CN200680042808 A CN 200680042808A CN 101309654 B CN101309654 B CN 101309654B
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M·德森达师蒂昂
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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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22098—Decalcification of valves
    • A—HUMAN NECESSITIES
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    • 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • 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
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

用于输送人工心脏瓣膜到主动脉瓣环的输送系统和方法。所述系统包括球囊导管(54)，在所述导管上具有操控机构，用于以顺行的方式将球囊可扩张的人工心脏瓣膜(50)通过导入器(70)输送到主动脉环。球囊导管经过导入器——其通过其尖端和胸壁中的小切口进入左心室。球囊导管包括就在远端球囊(52)近端的偏转部分(164)，以协助人工心脏瓣膜在主动脉环内以正确的方向定位。偏转柄(154)中的滑动器可以被连接到使偏转部分运行的偏转丝上。方法包括：使用在左心室尖部的穿刺孔周围的两个同心环荷包缝合线(44)来保持从中穿过的器械周围的良好密封。人工心脏瓣膜可以被安装在已存在的钙化瓣叶上，也可以利用预膨胀瓣膜成形术。

Description

经心尖心脏瓣膜输送系统
技术领域
本发明涉及用于输送人工瓣膜到心脏的方法和系统。更具体地，本发明涉及用于手术置换(替代，replacement)心脏瓣膜而不打开胸腔、并且使患者处于旁路(bypass)下或不使患者处于旁路下的方法和装置，不使患者处于旁路下被称为“非体外循环”(off-pump)。 
背景技术
当自体心脏瓣膜(native heart valve)变窄时——其一般被称为狭窄，或者当自体瓣膜渗漏或返流时——如当小叶被钙化时，表明需要心脏瓣膜置换。置换瓣膜时，自体瓣膜可以被切除并且被生物瓣膜或机械瓣膜所置换。机械瓣膜需要终生的抗凝血药物以防止血凝块形成，并且通过胸腔通常可以听到瓣膜的滴答声。生物组织瓣膜一般不需要这种药物。组织瓣膜可以从尸体获得或可以是猪或牛的瓣膜，并且通常附着在合成的环状物上，所述环状物被固定于患者的心脏瓣膜环。 
传统的心脏瓣膜手术是在全身麻醉下进行的心脏直视方法。穿过患者的胸骨进行切割(胸骨切开术)，并且患者的心脏被停止而血流改道通过心脏-肺“心肺”旁路控制机(体外循环机，″cardiopulmonary″bypass machine)。瓣膜置换手术是具有明显的伴随风险的高创伤性手术，所述风险包括出血、感染、中风、心脏病发作、心律失常、肾衰竭、对麻醉药物的不良反应，以及猝死。在手术过程中达2-5％的患者死亡。外科手术后，患者可能由于栓子和与体外循环机有关的其它因素而被暂时干扰。手术后的最初2-3天在重症监护室度过，在那里心功能可以被密切监测。平均住院时间在1至2周之间，完全恢复还需要数周至数月。 
在近年来，“微创”手术(minimally-invasive surgery)和介入心脏病学的进步促进了一些研究者从事主动脉心脏瓣膜的经皮置换。经皮瓣膜技术公司(“PVT”)(Percutaneous Valve Technologies)——以前是Fort Lee，N.J，现在是加利福尼亚州欧文市的爱德华兹生命科学公司(Edwards Lifesciences of Irvine，CA)的一部分——已经开发了整合有生物人工瓣膜的球囊扩张支架(balloon-expandable stent)。支架/瓣膜装置在自体患病瓣膜上被展开，以永久地使瓣膜保持开放，从而减少了切除自体瓣膜的需要。PVT装置被设计用于在心脏导管插入术实验室中、使用荧光透视导向(fluoroscopic guidance)在局部麻醉下进行输送，因此避免了全身麻醉和心脏直视手术。 
其它现有技术的微创心脏瓣膜使用自扩张支架作为锚。在经皮/血管内主动脉瓣膜置换术中，人工瓣膜相对于冠状动脉口的准确放置是关键的。尽管支架的近端直到通过荧光透视被证实放置正确才从输送系统被释放，但自扩张支架一旦被释放仍然可以突然移动。因此，通常难以知道支架的末端相对于自体瓣膜和周围结构将在何处。 
Garrison等人的美国专利公开第2002/0151970号公开了用于主动脉瓣置换的两组件装置，其适合于通过患者的主动脉输送。支架被放置在血管内跨过自体瓣膜，然后置换瓣膜被定位在支架腔内并且连接到支架。通过在输送过程中使支架和瓣膜分开——所谓的“两阶段”方法，可以减小输送系统的轮廓(profile)。支架和置换瓣膜的框架可以是球囊式的或可自扩张的。 
一些研究者提议通过心室途径在动脉环处植入人工心脏瓣膜。例如，哈佛医学院的布莱根妇女医院(Brigham and Women′s Hospital ofHarvard Medical School)的Christoph H.Huber和其他人，已经建议了其中应用直接进入经心尖(transapical)方法在主动脉位置植入自扩张瓣膜支架的过程(E.g.，Huber等，Direct-access valve replacement a novelapproach for off-pump valve implantation using valved stents.J Am CollCardiol 2005；46：366-70)。Huber等的临床研究建议，所述方法只用于具有正常的、非钙化瓣叶的动物。更近期，Bergheim在美国专利公开第2005/0240200号中公开了另一种经心尖方法，其中可以植入或者球囊瓣膜或者自扩张瓣膜，并且也提议除去狭窄的瓣膜或使狭窄的瓣膜 脱钙。 
考虑到与以前已知的用于置换心脏瓣膜而不进行心脏直视手术或心肺旁路，即微创过程有关的缺点，需要更强有力并且创伤较小的改进方法和装置。 
发明内容
本发明的优选实施方式提供心脏瓣膜输送系统，用于不经开胸步骤输送人工(即，置换)心脏瓣膜到自体瓣膜位点。输送系统包括瓣膜输送导管，其具有操控部分以协助瓣膜的定位。 
按照一个方面，本发明提供非体外循环、微创的手术方法，该方法将人工心脏瓣膜植入患者的主动脉瓣环，同时患者的心脏保持搏动。方法包括提供球囊扩张的人工心脏瓣膜，所述瓣膜被安装在球囊导管远端上的球囊上。医师通过位于或接近患者的左心室尖的室壁产生穿刺孔并且通过该穿刺孔插入导入器鞘。球囊导管经过导入器鞘进入到左心室内。球囊的远端前移以便人工心脏瓣膜被定位在主动脉环内。最后，球囊膨胀以扩张主动脉环处的人工心脏瓣膜。 
所述方法也可以包括将第一列荷包缝合线(a first line ofpurse-string sutures)布置在通常处于一个方向的第一圈中，所述第一圈限定患者左心室尖或接近患者左心室尖的周界；并且随后将第二列荷包缝合线布置在通常与第一圈同心但方向相反的圈中。在周界内产生穿刺孔，并且在导入器鞘通过穿刺孔被插入后，系紧荷包缝合线以在周围造成密闭。 
期望地，球囊导管并入操控机构，并且该方法进一步包括操控左心室内的球囊导管以协助人工心脏瓣膜在主动脉环内定位。球囊导管也可以包括正位于球囊近端的偏转部分，其弯曲以使球囊和安放在其上的人工心脏瓣膜形成角度。球囊导管也可以具有推动器，其具有安放在偏转部分上并与球囊近端接合的远端套管。所述方法因此包括使用推动器和套管以推进球囊和安放在其上的人工心脏瓣膜，并且在使球囊膨胀之前，向近端移动推动器和套管相对于偏转部分的位置。理想地，推动器和套管在偏转部分弯曲之前向近端被移动。 
示范性的方法可以进一步包括使自体主动脉瓣叶处于适当位 置，以便膨胀球囊扩张人工心脏瓣膜至与其接触。此外，预先膨胀的球囊导管可以先于导入器鞘被插入，并且其上的球囊被膨胀以预膨胀主动脉环。可选地，方法可以包括扩张人工心脏瓣膜至与以前在主动脉环处植入的人工心脏瓣膜接触。 
将人工心脏瓣膜输送到患者的主动脉瓣环同时患者的心脏保持搏动的另一种非体外循环的微创手术方法包括，提供扩张状态的可扩张人工心脏瓣膜和具有远端的输送导管。心脏瓣膜在输送导管远端上被皱缩成收缩状态。创造肋间入口以暴露患者的左心室尖，并且在左心室尖处或接近左心室尖处形成穿刺孔。导入器鞘通过穿刺孔插入，并且输送导管经过导入器鞘并进入左心室。输送导管的远端被推进和操控以使人工心脏瓣膜在主动脉环内被适当地定位和定向。最后，人工心脏瓣膜在主动脉环处扩张至与其接触。 
输送导管理想地包括在其远端上的球囊，并且人工心脏瓣膜包括球囊扩张支架，其中扩张步骤包括将流体注入到球囊中以外向扩张人工心脏瓣膜至与主动脉环接触。自体主动脉瓣叶可以留在合适的位置，这样膨胀球囊扩张人工心脏瓣膜至与其接触。优选地，在插入导入器鞘之前，在远端具有球囊的预先膨胀的球囊导管经由穿刺孔被插入并且被膨胀以预膨胀主动脉环。 
本发明进一步包括微创人工心脏瓣膜输送系统，其包括穿过其中的腔不大于24弗伦奇(French)的引入器鞘和在远端上具有球囊的球囊导管，球囊导管进一步包括用于使远端偏转的操控机构。系统包括在球囊上皱缩的球囊扩张人工心脏瓣膜，其中在其上皱缩有人工心脏瓣膜的球囊导管的外部尺寸足够小以通过导入器鞘腔。 
理想地，操控机构包括球囊导管上的偏转部分，其正好位于球囊近端。偏转丝(deflection wire)可以连接到偏转部分远端并且延伸通过球囊导管到近端偏转柄。系统优选地具有推动器，其具有包绕偏转部分和球囊近端的大小的远端套管，推动器对于偏转部分是纵向可移动的。 
在一个实施方式中，球囊导管进一步包括连接于球囊相对端的内球囊膨胀管和外球囊膨胀管，它们被排列成彼此同心地滑动以便交替地拉长和缩短球囊。内管柄移动内球囊膨胀管。内球囊膨胀管通过 其中的球囊膨胀连接器连接到外球囊膨胀管的近端。侧面端口开向球囊膨胀连接器内限定的空间，侧端口协助引入膨胀流体到间隙中并且进入内球囊膨胀管和外球囊膨胀管之间的管状空间，用于膨胀球囊。外球囊膨胀管通过的偏转柄可以正好连接于球囊膨胀连接器的远端。外球囊膨胀管包括用于内球囊膨胀管通过的第一腔，和第二腔。偏转丝连接到偏转柄上的致动器(actuator)上并且通过外球囊膨胀管的第二腔到球囊导管的远端。 
系统理想地相对短，以使球囊导管具有的工作长度大小适合不超过大约24英寸(61cm)的导入器。同时，导入器优选地具有不超过大约13英寸(33cm)的总长度。 
对本发明的特征和优点的进一步理解在下面的说明书和权利要求中阐明，尤其是与附图结合考虑时，其中同样的部分具有同样的参考数字。 
附图简述 
本发明的特征和优点将被理解，因为参照说明书、权利要求书和附图，其变得更好理解，其中： 
图1是患者的示意性前视图，显示提供接近心脏左心室尖的肋间切口位置； 
图2A-2B是通过患者心脏左侧的截面图，显示按照本发明用于在植入人工心脏瓣膜之前扩张钙化的主动脉环的程序； 
图3A-3E是通过患者心脏左侧的截面图，显示按照本发明用于植入人工心脏瓣膜的程序中的几个步骤； 
图4A是在本发明的微创心脏瓣膜植入程序中使用的导入器的侧面图； 
图4B是图4A导入器的部件分解图； 
图5是按照本发明用于植入人工心脏瓣膜的示范性球囊导管的透视图； 
图5A是提供图4A的导入器和图5的球囊导管之间的连接的加载器的透视图； 
图6A是图5的球囊导管的放大局部平面图； 
图6B是图5的球囊导管沿着垂直面的放大局部图； 
图7是如在图6B中所见的球囊导管的近端的放大局部部分； 
图8是管段的孤立侧面图，所述管段在一个末端上具有抗旋转部件，形成图5的球囊导管的一部分； 
图9是形成图5的球囊导管的一部分的外部球囊膨胀管的近端的孤立侧面图； 
图10是形成如在图6B中见到的球囊导管的一部分的推动器柄的放大截面图； 
图11是在图6B中见到的球囊导管的远端偏转部分的放大截面图； 
图12是本发明的球囊导管的远端球囊在其扩张状态下的放大截面图； 
图13是球囊导管的远侧软尖端的放大截面图； 
图14是球囊导管远端的放大正视图，显示球囊在其缩小状态部分地被推动器套管包围；和 
图15是球囊导管远端的放大正视图，显示缩小球囊周围的保护鞘。 
具体实施方式
心脏是略微圆锥形的中空肌肉器官；它在纵隔中位于肺之间并且被心包膜包绕。心脏倾斜地位于胸骨体后的胸中并且邻近肋软骨部分，而且向胸腔的左半部分比向右半部分突出的更远，所以其大约三分之一位于正中面的右侧而三分之二位于正中面的左侧。心脏被间隔再分为右半部分和左半部分，并且缢痕将该器官的每一半部分再分成两个腔，上面的腔被称为心房，下面的腔为心室。心脏因此由四个室组成：右心房和左心房，右心室和左心室。 
如在图1中见到的，左心室尖LVA指向下、向前，和向左(从患者的视角)。心尖典型地位于左侧第五肋间隙(或在第四肋和第五肋之间)的后面，离胸骨中线8至9厘米，并且比左侧乳头低大约4厘米和距左侧乳头内侧2毫米。因此，对左心室的进入可以通过如以虚线显示的肋间切口20实现，位于左侧第五肋间隙上。这种方法通常 被成为“迷你胸廓造口术”(mini-thoracotomy)。 
在本发明优选的一个实施方式中，外科医生在现有的一般被钙化的自体瓣叶上植入人工心脏瓣膜。有用于除去钙化瓣叶的程序和装置，但是与之有关的风险，包括钙化材料释放到血流中，不是微不足道的。因此，优选将人工心脏瓣膜直接安装在自体瓣叶上并且包含自体瓣叶的心脏瓣膜置换程序。 
本领域技术人员将会意识到，在主动脉瓣膜内配置人工瓣膜之前预先膨胀狭窄的主动脉瓣的瓣叶和环，可能是必要的。图2A和2B是瓣膜成形术程序的两幅快照，该程序最初可以被实施以将自体心脏主动脉瓣叶外向压缩到窦房结和升主动脉上。如上面提到的，自体主动脉瓣叶可以实质上被钙化，并且瓣膜成形术对于破裂或推开硬化组织可能是必需的。预先膨胀增加了通过主动脉瓣的流动面积并且在瓣叶中产生足够大小的开口以接收人工瓣膜。使用可扩张部件如扩张球囊导管，优选地实现预膨胀。瓣膜环的预膨胀的一个例子在2005年6月21日公布的Cribier的美国专利第6,908,481号中被看到，其明确地引入本文作为参考。 
图2A说明通过左心室LV中的心尖穿刺孔32引入导丝30。导丝30的远端34延伸通过自体主动脉瓣AV并且进入升主动脉AA。远端34可以在主动脉弓上进一步延伸，如在图2B中见到的，但是最小的延伸是穿过主动脉瓣AV。 
图2B说明在远端具有膨胀球囊42的球囊导管40，其通过导丝30并且穿过心尖穿刺孔32。此处应当指出，一个或多个荷包缝合线44穿过穿刺孔32周围的左心室尖的组织。这些缝合线44在最初的穿刺孔形成之前被预先植入。在一个优选的实施方式中，外科医生通常将第一列荷包缝合线布置在通常处于一个方向的第一圈中，并且随后将第二列荷包缝合线布置在通常与第一圈同心但方向相反的圈中。结果是两个单独的荷包缝合线44的同心圆限定了其中形成穿刺孔的外围。荷包缝合线44可以因此被拉伸以系紧周围心室组织——不论任何物体通过穿刺孔。尤其是，在导丝30和球囊导管40周围，荷包缝合线44都被拉紧。在相反的方向安装单独的荷包缝合线44帮助预防心室组织的撕裂，并且对无论哪一种延长物体通过穿刺孔都提供更一致的压缩。 
如在图2B中显示的，膨胀球囊42径向地向外扩张，与自体主动脉瓣叶接触。根据关于具体主动脉瓣大小的信息，球囊42被选择以使它向外扩张并且将主动脉瓣叶略微压缩到周围的主动脉壁上。有各种用于评定特定患者主动脉瓣大小的方法，包括超声波，其将不会在本文中描述。足以说明，在图2B中见到的瓣膜形成术程序后，自体主动脉瓣叶相对于主动脉壁被向外压缩并且产生实质上圆形的孔。关于预膨胀和瓣膜置换的其它细节可以在2002年5月2日提交的、申请人的共同未决美国专利公开第20030014104号中找到，其明确引入本文作为参考。 
现在参照图3A-3E，使用经心尖方法配置和植入本发明人工心脏瓣膜的优选方法现在将更详细地描述。本文公开的装置和方法尤其适合置换狭窄的主动脉瓣，并且同样地，在图2A-2B中见到的预膨胀程序一般是在瓣膜植入之前以便使环和瓣叶的轮廓平滑。然而，应当指出，本文描述的程序可以在没有瓣膜预膨胀的情况下进行。 
此外，本发明程序可以作为第一次瓣膜植入或以前植入的补充。相对大比例的人工心脏瓣膜的接受者是年长者，一般为60岁以上。随着时间的推移，已经知道人工心脏瓣膜功效降低并且甚至失效。在七十岁甚至八十岁的人中重新做手术是成问题的。然而，如本文公开的微创程序消除了开心手术和潜在的心肺旁路，因此对于老年患者更为可取。因此，本发明考虑在已有的人工瓣膜植入物上经心尖植入人工心脏瓣膜。在这种情况下，尽管预膨胀步骤是可能的，但其一般是不需要的。 
在程序本身的讨论之前，应当指出，本发明的优选输送系统将参照图4-15在下面更详细地描述。在说明最终将瓣膜植入主动脉环中所采取的步骤之后，本输送系统的工作方式可以被更容易地理解。 
本文描述的人工心脏瓣膜植入程序可以与心肺旁路联合进行，或在所谓的非体外循环程序中没有心肺旁路而进行。旁路的必要性取决于许多因素，包括患者的年龄、对这种程序的易损性、和天然瓣叶的存活性。理想地，在非体外循环下进行植入程序。 
使用身体定径机(physical sizer)或超声心动图，外科医生或心脏病学家首先测定主动脉瓣的大小。然后，医师和手术室工作人员在 球囊导管54的球囊52上使可扩张的人工瓣膜50皱缩(目前描述的一些元件可以在图3A-3E的程序图中见到，而其它元件可以在图4-15的系统图中见到)。通过已经插入穿过左心室尖穿刺孔32的导入器鞘70，外科医生推进导丝60(其可以是在预膨胀程序中使用的相同导丝30)上的球囊导管54。 
用于预膨胀程序的同一荷包缝合线44也可以用于密封导入器鞘70周围的心肌组织。在没有预膨胀程序的情况下，荷包缝合线44在最初的穿刺孔形成之前被预先植入。如同以前所述，外科医生将第一列荷包缝合线布置在通常处于一个方向的第一圈中，并且随后将第二列荷包缝合线布置在通常与第一圈同心但方向相反的圈中。结果是两个单独的荷包缝合线44的同心圆限定了一个外围——在其中形成穿刺孔并且其对导入器鞘70周围进行密闭。 
此外，扩张穿刺孔32的内径并且跨过导丝60的扩张器(没有显示)可以在导入器鞘70之前被插入。优选的扩张器直径在12和22弗伦奇之间的范围。导入器鞘70包括导入器的远端，其将在下面被描述。不大于24弗伦奇，理想地为22或24弗伦奇(Fr)的导入器鞘直径是优选的。 
图3A显示导入器鞘70通过穿刺孔32和在向上延伸通过钙化的主动脉瓣AV的导丝60上穿过进入左心室。外科医生将导入器70的远端72放置在恰好主动脉瓣AV的流入侧，如在图3A中见到的。在这点上，本领域技术人员应当理解，使用不透射线的标志物(radiopaque markers)和荧光透视(fluoroscopy)，或使用其它成像系统，如经食道超声(transesophageal echo)、经胸廓超声(transthoracicecho)、血管内超声成像(intravascular ultrasound imaging(IVUS))，或是不透射线的可注射染料，导入器鞘70相对于主动脉瓣AV的位置，以及系统的其它元件的位置被监控。 
图3B显示球囊导管54在导丝60上和通过导入器鞘70的前进。最后，如在图3C中见到的，人工心脏瓣膜50定位于主动脉环并且在自体主动脉瓣叶之间。图3C也说明导入器鞘70从图3B中它的更前的位置的撤回。可以在导入器鞘72的远端上提供的不透射线的标志物，以便更准确地确定它相对于瓣膜50和球囊52的位置。 
另外，通过使不透射线的标志物定位于人工瓣膜50的远端和近端，可以完成人工心脏瓣膜50的精确定位。理想地，外科医生可以通过启动球囊导管54内的操控机构或偏转机构，调整瓣膜50的位置，如下文将描述的。而且，通过从其近端扭曲球囊导管54并且在荧光透视下观察瓣膜(或球囊导管)上的特定标记物，可以相对于自体主动脉瓣的尖端和接合处调整瓣膜50的转动方向。显示了通向一个升主动脉窦的一个冠状动脉口80，并且本领域的技术人员将理解，不使人工瓣膜50闭塞两个冠状动脉口是重要的。也应当指出，尽管图3A中显示主动脉瓣AV的自体瓣叶是合紧的，并且在图3B和3C中被球囊导管54灵活地移位，在预膨胀程序中，它们可能实际上被进一步向外压缩到主动脉环上。 
图3C显示在球囊52周围皱缩的、收缩或未扩张状态的人工心脏瓣膜50。当外科医生对瓣膜50的正确定位和转动方向满意时，球囊52如图3D中所见被扩张。自体主动脉瓣AV的正确的大小测定使外科医生能够选择最佳尺寸的瓣膜50，以使它向外扩张到与主动脉环良好接触。术语“良好接触”意指足够的接触以确保人工心脏瓣膜50在植入后不移动。然而，瓣膜的过度扩张可以损害周围组织或妨碍邻近瓣膜的功能。 
许多装置可用以帮助将人工瓣膜50锚定到主动脉环中，如倒刺(barb)和类似物。用于本发明的人工心脏瓣膜50的优选结构在2004年6月30日提交的、共同未决美国专利申请系列第10/883,575号中被公开，在此明确引入其公开内容作为参考。当然，瓣膜50可以有各种不同的形式，但是通常包括支撑瓣膜结构的可扩张的支架部分。支架部分具有足够的径向强度以在治疗位点支撑瓣膜并且抵抗狭窄瓣叶的弹回。在美国专利第6,730,118和6,893,460号中，可以见到关于优选的球囊扩张瓣膜实施方式的其它细节，它们都明确引入本文作为参考。优选的人工心脏瓣膜50包括在它外表面上的足够的不规则性，因此它可以在不使用倒刺或其它组织刺穿结构的情况下被锚定在主动脉环内。 
一旦瓣膜50被正确地植入，如在图3D中见到的，球囊52被缩小，并且包括球囊导管54的整个输送系统经导丝60被撤回。然后 导丝60被撤回，接着导入器鞘70被撤回。最终，先前描述的荷包缝合线44被系紧并打结以便封闭穿刺孔32，如在图3E中见到的。 
认识到本发明的心脏瓣膜输送系统特别适合顺行的、左心室尖、“经心尖”方法是重要的。更具体地，迷你胸廓造口术需要相对短的器械。因此，延伸到体内的导入器鞘70部分理想地不大于大约8英寸(20厘米)长，并且延伸到导入器鞘70内的球囊导管54的长度，即“工作长度”理想地不大于大约24英寸(61厘米)。相对短长度的球囊导管54和导入器鞘70的进一步细节将在下面被提供。本文描述的人工心脏瓣膜输送系统的短长度也非常适合其它的解剖学途径，包括经由颈动脉或锁骨下动脉。短长度的系统是理想的，因为，相对于较长的系统，它增强了远端的可控制性和可操控性，这有助于改善精确性并且减少瓣膜定位的时间。 
本发明的输送系统基本上包括导入器100、球囊导管54、和伴随的联接器以及操作结构，包括在导入器和球囊导管之间的加载器140，如在图5A中见到的。导入器100在图4A和4B中说明，而球囊导管54和加载器140在图5-15中说明。应当指出，输送系统与用于经皮植入人工主动脉瓣膜的另一系统相似，该系统在2005年6月13日提交的、共同未决的美国专利申请系列号11/152,288中被公开，并且明确引入本文作为参考。尽管一些特征是共同的，但本系统在几个方面不同，所述几个方面使它更适合用于经心尖方法。 
如在图4A和4B中见到的，导入器100包括上述的远端鞘70，该远端鞘70与包含一系列阀(valve)的导入器架(导入器罩)102相连接。图4B的部件分解图显示了从导入器架102分离的末端帽104。末端帽104包括与加载器140接合的凸缘接管头(法兰接管头，flangednipple)105，如下文将解释的。末端帽104以拧螺母的方式或以其它方式连接到导入器架102上并且保持在那里，从近端到远端串连排列为：十字阀(cross-slit valve)106、间隔装置108、盘状阀110、和鸭嘴兽阀(duck-bill valve)112。当没有器械穿过导入器100和当几种不同大小的器械从其穿过时，这三种阀行使提供密封的功能。例如，如先前显示，阀在导丝60和球囊导管54周围进行密封。导入器鞘70延伸进入到体腔内，而导入器架102位于体腔外。在一个优选的实施方 式中，导入器鞘70具有外部亲水性涂层并且具有大约8英寸的长度，因而它可以通过进入切口20(见图1)延伸进入到左心室中并且到达主动脉环。 
导入器鞘70通过管120的中间部分连接到导入器架102上。管120的大小理想地比鞘70略大，因而它可以在其近端周围收缩。管120的近端包括与从架102延伸的远端接管头124接合的密封凸缘(密封法兰)122。优选地，在这两个接合部分之间使用粘合剂。螺母架126在管120上越过并且连接到螺纹128上，所述螺纹128在架102上刚好位于接管头124的近端处被提供。以这种方式，各种组件可以被单独制造(典型地铸模或挤出)并且在装配过程中被容易地连接在一起。 
侧端口管130以一定角度远离导入器架102而延伸并且终止在三通活拴132。这使得使用者能够通过导入器100的腔注入药物或其它的流体——即使装置如球囊导管54在其中存在。 
图5透视说明球囊导管54，其包括在近端以小型快速接头(luerfitting)142起始并在远端以软尖端(soft tip)144终止的相关部件的集合。在图5A中以透视显示的加载器140将在下面更详细地描述并且提供球囊导管54和上述导入器100之间的连接。球囊导管54也在图6-15的平面图、截面图、和单独的视图中被显示，并且从近端到远端包括：具有小型快速接头142的内管柄150、球囊膨胀连接器152、偏转柄154、外球囊膨胀管156、推动器柄158、推动器主体160、推动器套管162、偏转部分164、和刚好位于软尖端144近侧的可扩张球囊52。内螺纹加载器帽170安装在推动器主体160之上并且连接到加载器140。 
在具体描述示范性球囊导管54之前，将要说明它经由加载器140与导入器100的相互作用。加载器140具有管型的主体，在近端具有用于与加载器帽170上的内螺纹连接的外螺纹172，并具有适合导入器100内的外部略呈锥形的远前端(distal nose)174。加载器140包括一对与其平行延伸的、带内面搭钩脊(internally facing snap ridge)178的附加的悬臂式指状物(cantilevered fingers)176，用于将加载器140固定到导入器100。环状加载器密封装置180——其在图6A和6B中更好地看到，位于加载器帽170内。环状加载器密封装置180包括一对优选尼龙的环状垫圈182，其夹在优选硅树脂的环状弹性密封物184 之间。 
加载器140便于球囊导管54引入到导入器100中。如上面描述的，导入器架102包含一系列阀106、110、112，在不同大小的医疗器具缺乏或存在下，其聚集在一起提供针对通过导入器100流出的血液的有效流体密封。加载器140的远前端174通过导入器架102和这些阀106、110、112延伸以保持它们开放以及提供与导入器鞘70的腔尺寸相匹配的平滑内腔。以此方式，具有在球囊52周围皱缩的人工瓣膜50的略不规则形状的球囊导管54可以平稳地穿入导入器鞘70。 
在如图5中见到的球囊扩张之前，加载器140在球囊导管54的远端范围连接并且向近端移动，直到它可以加载器帽170连接。将加载器帽170螺纹连接在加载器140的外螺纹172上轴向压缩加载器密封装置180，以提供流体紧密配合并且相对于球囊导管54锁住加载器140。在这点上，包括球囊160的球囊导管54的远端，位于加载器140的管状体内。远前端174插入到导入器架102中并且悬臂式加载器指状物176与末端帽104的凸缘接管头105接合(图4A)。球囊导管54因此连接到导入器100中。然后加载器帽170被解开，允许球囊导管54相对于加载器140的轴向移位。将整个球囊导管54滑行到远端允许其最远端的不规则外形安全通过阀106、110、112并且进入到导入器鞘70中。在瓣膜植入程序中，加载器140保持与导入器100连接，并且如果需要，加载器帽170可以被重新加紧以确保球囊导管54和导入器100的相对位置。 
现在将针对图5和图6-15的更详细的视图描述球囊导管54的各种组件。参照图6A和6B，球囊膨胀连接器152包括具有近端部分188和远端部分190的主体186。纵向延伸通过近端部分188的是第一孔192，而纵向延伸通过远端部分190的是与第一孔192相通的第二孔194。第一孔192具有非圆形的截面结构，其理由将在下面更详细的讨论。布置在远端部分190的远端上的是远端连接器螺母196，而布置在近端部分188近端上的是膨胀帽198，其保持膨胀连接器152内的膨胀密封物199。第二孔194在其远端变宽为放大的开口，其接收同样连接在偏转柄154内的连接器接管头200。 
本发明的球囊导管54理想地并入相对滑动的同心内球囊膨胀 管和外球囊膨胀管，该管连接到球囊52的相对端。没有具体描述，同心管允许球囊52变短或变长，这取决于两者之间的相对运动。这提供了在球囊52被缩小后轴向延伸球囊52的能力，因而其径向轮廓减小并且它可以容易地从周围结构被解剖地或其它的方式除去。膨胀流体，优选盐水，在同心球囊之间提供的管状空间中通过。在本发明中，球囊52扩张人工心脏瓣膜52，以将它植入在环中，其后球囊在从瓣膜内除去之前被缩小并轴向拉长。这种同心管结构的结构和功能的详细讨论可以在美国专利第5,968,068号中见到，其公开内容明确引入本文作为参考。 
在图6B中见到，内球囊膨胀管210的近端延伸到内管柄150中，并且在图7的放大视图中也可见到。管210被同心地固定在管段212(在图8中单独见到)内，管段212的近端又被固定在管柄150的孔内。固定在管段212的远端的抗旋转部件(抗旋转块)214在膨胀连接器主体186的第一孔192内轴向滑动。第一孔192和抗旋转部件214在径向截面上是非圆形的，以防止在其之间的相对旋转。优选地，这些部件是方形的。这也防止内管210和膨胀连接器152之间的旋转。 
在图6B和7中看到外球囊膨胀管156的近端延伸到偏转柄154中以在连接器接管头200内被固定地接收。如在图9中看到的分离图，外球囊膨胀管156在偏转柄154的远端具有比它在连接器接管头200中的末端更大的截面。管156的外部分在偏转柄154的中空主体230的远端的连接器内系紧，而较小直径的流体运送管215通过偏转柄延伸到连接器接管头200。流体运送管215接收内球囊膨胀管210，而另一个在外球囊膨胀管156内限定的腔接收偏转丝，如下面所述。连接器接管头200相对于膨胀连接器152和偏转柄154被固定(如，被粘附或类似地被系紧)，使这两个部件基本上接近。因此，如在图6B中见到的，内管柄150相对于膨胀连接器152的移位也使内管210相对于外管156移位。 
在球囊膨胀连接器主体186的远端部分190中的Y端口216通向侧管和活拴阀(stop-cock valve)218。阀218提供用于膨胀球囊52的盐水源的连接点。主体186中的第二孔194开向第一孔192，第一孔192又在膨胀连接器152近端上的膨胀帽198处被密封。盐水因此以远 端方向通过连接器接管头200经过内管210外部和外管156的流体运送管215内部的管状空隙。管210、215之间的同心空间提供盐水进入远端球囊152的通路。 
仍然参照图7，内管柄150的特征是一对相对的悬臂式夹(cantilevered clips)220，其功能是暂时将管柄连接到膨胀连接器152近端上的膨胀帽198。通过按压夹220的近端，它们的远端打开并且内管柄150可以在相对于膨胀帽198的近端方向被移位。在短距离一般是1-2厘米之间行进后，夹220的远端位于膨胀帽198上的凸缘接管头222上并且可以被松开，从而夹220上面向内的锯齿啮合凸缘。这种操作相对于外球囊膨胀管156移动内球囊膨胀管210，其又引起球囊52的相对轴向末端移开。如上面提到的，这种运动促使缩小球囊的轮廓减小。夹220上的锯齿和凸缘接环头222之间的相互作用保持外管和内管156、210的相对位置，从而球囊52以其延伸结构保持锁定，易于去除。 
内管柄150近端上的小型快速接头(luer fitting)142提供放射造影剂注射的进入点。小型快速接头142向内部球囊膨胀管210的腔开放，管210延伸到球囊导管54的远端，在所述远端提供出口。造影剂对于检查人工瓣膜植入后的瓣周渗漏(perivalvular leaks)是有用的。 
参照图6B和图7，偏转柄154包括一般中空的主体230，其在接收滑动器(slider)232的一侧上具有轴向缝隙，见图6A。中空主体230限定了一系列在滑动器232对面的局部外圆周肋状物(partialexternal circumferential ribs)234以便于使用者夹持。尽管从图7的截面图不是显而易见的，但滑动器232在柄主体230内连接到偏转丝236，偏转丝236进入外球囊膨胀管156的较大部分内提供的一个腔中。图11的放大图说明外管156的远端并且显示从其延伸的偏转丝236。偏转丝236连接到球囊导管54远端的详述将在下面提供。足以说明，滑动器232的轴向运动转换成偏转丝236的轴向运动。 
参照图6A-6B和图10，推动器柄158包括管状主体240，其具有滑动接收通过其中的外管156的纵向延伸的内腔242。一对连接器螺母244、246连接主体240的各自近端和远端，并且尤其是与在其上提供的外螺纹配合。管状侧臂(tubular side arm)248从主体240有角度 地延伸并且与其中的腔242相通。推动器主体160的近端理想地在主体240的远端中连接，并且推动器主体内限定的腔与推动器杆主体240的腔242流体相通。由于侧臂248开放到围绕外球囊膨胀管156的腔242中，通过侧面臂被引入的流体进入在外管156和推动器主体160之间的同心空隙。侧臂248提供导入血管造影流体、肝素、或其它这样的治疗物质的多功能端口。近端的连接器螺母244轴向压缩密封元件252以将推动器柄158固定到外球囊膨胀管156，并且提供其间的流体密封。 
现在参照图11，推动器主体160的远端连接到张开的(flared)推动器套管162。尽管被单独显示，在通过导入器鞘70期间，推动器套管162包围偏转部分164和球囊52的近端部分。偏转部分164通常包括包围内部螺形弹簧264的外部柔韧盖262。推动器主体160和推动器套管162促进偏转部分164和连接的球囊52前进通过导入器鞘70，所述球囊52具有在其上皱缩的瓣膜50。推动器主体160相对于外球囊膨胀管156的近端撤回使偏转部分164和球囊52脱离(free)。如在图5中见到最好的，推动器柄158可以通过松开近端连接器螺母244在球囊膨胀管156上向近端滑动，从而相对于管156拉回推动器主体160。 
如上面提到的，偏转柄154支撑连接到偏转丝236的滑动器232(图6A)，在图11中看到偏转丝236延伸通过偏转部分164。在这方面，偏转丝236从偏转柄154沿着外球囊膨胀管156中的一个腔延伸。管156正好在偏转部分164的柔韧盖262内终止，并且更具体的是，在刚性的近端管段274内被固定，柔韧盖262也连接于管段274，如应用粘合剂。螺形弹簧264理想地包括在两端的紧密缠绕部件270、272，其中近端的一个紧密缠绕部件被固定在管156的远端内。偏转丝236从外管156离开并且在螺形弹簧264的外部周围经过，最后固定到偏转部分164的远端管段276上。管段276提供对柔韧盖262、螺形弹簧264、和球囊52近端的刚性锚定。 
偏转丝236中的张力拉紧远端管段276的一侧，其引起偏转部分164的远端在该方向弯曲。当然，通过使整个球囊导管54环绕它的轴旋转，偏转部分164可以在任何方向被操控。螺形弹簧264提供柔 韧性和弹性，以便偏转丝236上的张力释放允许偏转部分164返回直线方向。因为球囊52连接到偏转部分164的远端，在其上皱缩的人工心脏瓣膜50可以在自体环内被精确地确定方向。 
再次参照图6A和6B和12，球囊52包括第一锥形部分288、主要圆柱部分290、和第二锥形部分292。人工心脏瓣膜50理想地在主要圆柱部分290周围皱缩，如在图12中的剖示图中显示的。球囊52可以由尼龙形成，并且在6-8atm的破裂压力下被评价。在优选的实施方式中，球囊的扩张直径在大约20至28mm的范围，具体的尺寸取决于被植入的心脏瓣膜50的尺寸。 
内球囊膨胀管210通过球囊52并且在被上面提到的软尖端144覆盖的远端终止，最好见图13。软尖端144促进球囊导管54的导入并且减少对周围组织的损伤。这在本发明的优选程序——其中导管进入左心室尖并且通过主动脉瓣膜行进到升主动脉中——是特别重要的。如图3D中见到的，导管的远端可以延伸得足够远以进入主动脉弓，而软尖端144因此防止了对周围血管组织造成破裂或其它擦伤。图13也说明内管210和软尖端144的开放远端，在植入之后，放射造影剂可以通过它们被注入以检验瓣膜充分性(valve sufficiency)。 
图14是球囊导管54远端的正视图，显示缩小的球囊52和被推动器套管162包绕的球囊近端。本图也显示内管210中提供的一系列膨胀孔298，盐水通过所述孔来膨胀球囊52。 
图15显示当球囊导管54在其包装中输送时，球囊导管54的远端。具体的，保护鞘300被提供在球囊52的周围，其在植入手术之前在手术室中被除去。 
在使用中，本发明提供用于在主动脉环中植入人工心脏瓣膜50的新的有效的方法。所述程序的步骤，至少直至最后的植入步骤，已经在上文参考图1-3中描述。现在将提供在进行整个程序中示范性球囊导管54的有利应用的描述。 
首先，如上所述，医师测定患者的环的尺寸。这可以通过在左心室尖创造切口20和穿刺孔32和将定径器插入到主动脉环中而在机体中完成。然而，穿刺孔32可能不足够大以通过传统的定径机，而且可供选择的技术如超声心动描记或其它这样的成像系统可以被利用。 
随后，球囊导管54、导入器100、加载器140、和人工心脏瓣膜50被选择，并且通过将它们从任何包装中取出并按照需要冲洗或消毒，准备使用。可以进行上文针对图2A-2B描述的预膨胀步骤以扩大或破裂主动脉环中现有的钙化物。 
可以用许多方法完成人工心脏瓣膜50在球囊52上的皱缩过程，而且市场上有用于在球囊上皱缩球囊扩张支架的合适装置。在一个优选的实施方式中，具有如照相机的可变光圈(aperture iris)一样工作的压缩机构的装置被利用。在这样的装置中，包绕人工心脏瓣膜50外围的多个连续部分独立但一致地关闭，从而均一的内向压力被施加在心脏瓣膜上。所述装置一般为人工操作。 
随后，前述的推动器主体160和展开的套管162在球囊52的近端上向远侧推进，如在图14中见到的。通过旋紧连接器螺母244，推动器柄158被固定在此位置。然后加载器140在球囊导管54的远端上被固定，其包括偏转部分164、球囊52和人工瓣膜50的集合。通过加载器帽170与加载器主体的近端螺纹172的接合，加载器140被固定在这个位置。 
在这点，或在球囊导管准备的同一时间，导入器100被定位在左心室内，如图3A中见到的。另外，荷包缝合线44在导入器鞘70周围保持流体紧密密封。在整个程序过程中，心脏可以继续跳动。医师将加载器140的远前端174插入到导入器架102的近端开口并且使加载器到达最低点，以使悬臂式指状物176接合导入器的凸缘接管头105。在这点，球囊导管54准备好导入体内。 
加载器帽170的松开允许球囊导管54相对于加载器140和导入器100向远侧推进。然后，医师通过松开连接器螺母244(图10)并且拉回外球囊膨胀管156上的推动器柄158，从偏转部分164和球囊52的近端部分撤回推动器套管164。医师推进导管54直到它到达图3C中显示的位置，这也涉及导入器鞘70的撤回。使用荧光透视标记物和荧光检查可见到整个操作，并且通过导管54的轴向运动和旋转结合偏转部分164的角度变化，完成球囊52和安放在其上的人工瓣膜50的准确定位。具体而言，当人工瓣膜54前进时，通过导管54的总运动以及用滑动器232拉紧偏转丝236轻微改变它的角度方向(图6A)， 它尽量沿着自体主动脉瓣AV的流动轴(flow axis)排列。 
最后，瓣膜50如图3被正确定位，注意当扩张时，瓣膜50不易于阻塞任一冠状动脉口80。然后，通过活栓218(图6B)注射盐水，其经过Y-端口216并进入到外球囊膨胀管和内球囊膨胀管156、210之间的管状间隙中。盐水向远端持续经由球囊导管54中的流体通路并充满球囊52。球囊52是具有最大扩张直径的类型，其以前已经被选择以便将人工心脏瓣膜52适当地扩张到与周围主动脉瓣AV和钙化的瓣叶——如果它们保持在适当位置——接触的最适直径。该步骤在图3D中被说明。 
随后，球囊52中的盐水压力降低使其缩小。通过向膨胀柄152远端移动内管柄150而轴向延伸球囊52的相对端，辅助缩小(见图6B)。可以从球囊导管54的近端口(proximal lure)142注入放射造影剂通过远端软尖端144离开并且测试刚刚植入的人工瓣膜50的效力。如果瓣膜正确地行使功能，球囊导管54被撤回导入器鞘70中，其从穿刺孔32被移除。荷包缝合线44被关闭以密封穿刺孔32。 
又一次，本文描述的输送系统特别适合顺行的、经心尖方法，这部分是由于它的相对短的长度。参考图4A，导入器100的全长是大约13英寸(33厘米)，而可以在机体内延伸的鞘70的长度是大约8英寸。延伸到导入器100中的球囊导管54的部分(即，从远端软尖端144到大约偏转柄154的球囊导管部分)不多于大约24英寸(61厘米)，其允许大约11英寸(28厘米)的球囊导管延伸超过导入器远端72(见图4)。应当指出，输送系统相对短的长度不适合经由周围血管的较长的、更迂回的方法，如在共同未决的美国专利申请系列第11/152,288号中显示的。同样，操控机构在球囊导管54本身上被提供，而不是在用于导向球囊导管的第二导管上，如在申请系列号11/152,288中完成的。球囊导管的短的长度和直接操作的能力大大提高了人工心脏瓣膜在主动脉环内的成功定位。 
尽管本发明已其优选的实施方式被描述，应该理解，被使用的词语是描述性词语而不是限制性的。因此，在附加的权利要求内可以进行改变而不背离本发明的真正范围。 

Claims (13)

1.微创人工心脏瓣膜输送系统，其包括：
导入器鞘(70)，其具有不大于24弗伦奇(直径8mm)的穿过其的腔；
在远端上具有球囊(52)的球囊导管(54)，所述球囊导管(54)进一步包括用于偏转所述远端的操控机构，所述操控机构包括偏转部分(164)和偏转丝(236)，所述偏转部分(164)在所述球囊导管(54)上并刚好位于所述球囊(52)近端，所述偏转丝(236)连接到所述偏转部分(164)的远端以与其进行固定并且延伸通过所述球囊导管到达近端偏转柄(154)，其中所述球囊导管(54)具有的工作长度大小适合不超过大约24英寸(61cm)的导入器(70)；和
在所述球囊(52)上皱缩的球囊可扩张人工心脏瓣膜(50)，
其中，在其上具有所述人工心脏瓣膜(50)的所述球囊导管(54)的外部尺寸小到足以穿过所述导入器鞘腔。
2.权利要求1的系统，其中所述偏转部分包括包围内部螺形弹簧的外部柔韧盖。
3.权利要求2的系统，其中所述螺形弹簧具有在两端的紧密缠绕部件，并且所述偏转丝在螺形弹簧的外部周围经过且固定到偏转部分(164)的远端管段(276)上，所述远端管段(276)提供对柔韧盖(262)、螺形弹簧(264)和球囊(52)近端的刚性锚定。
4.权利要求2或3的系统，其进一步包括：
具有远端套筒的推动器(160)，所述远端套筒的大小为包绕所述偏转部分(164)和所述球囊(52)近端，所述推动器(160)可相对于所述偏转部分(164)纵向移动。
5.权利要求1至3中任一项的系统，其中所述球囊导管(54)进一步包括：
内球囊膨胀管和外球囊膨胀管(156；210)，其连接到所述球囊(52)的相对端并且排列成相对彼此同心滑动以交替地拉长和缩短所述球囊(52)；
用于移动所述内球囊膨胀管(210)的位置的内管柄(150)；
球囊膨胀连接器(152)，所述内球囊膨胀管(210)通过其中，并且所述外球囊膨胀管(156)的近端与其连接；和
开向被限定在所述球囊膨胀连接器(152)内的空间的侧端口(248)，所述侧端(248)适合于将膨胀流体引入所述空间并且进入到所述内球囊膨胀管(156)和所述外球囊膨胀管(210)之间的管状空间，用于膨胀所述球囊(52)。
6.权利要求5的系统，其中：
所述偏转柄(154)刚好连接到所述球囊膨胀连接器(152)远端，并且所述外球囊膨胀管(156)通过所述柄，所述外球囊管(156)包括用于通过所述内球囊膨胀管(210)的第一腔、和第二腔；和
所述偏转(236)连接到所述偏转柄(154)上的致动器并且通过所述外球囊膨胀管(156)的所述第二腔到达所述偏转部分(164)的远端。
7.权利要求1至3中任一项的系统，其中所述导入器(70)具有不大于大约13英寸(33厘米)的总长度。
8.权利要求4的系统，其中所述推动器套管设置在所述偏转部分上。
9.权利要求2的系统，其中所述偏转柄(154)包括主体(230)，其在接收滑动器(232)的一侧上具有轴向缝隙，所述滑动器(232)被连接以拉紧所述偏转(236)。
10.权利要求2的系统，其中所述偏转丝(236)通过外球囊膨胀管(156)中的腔。
11.权利要求1至3中任一项的系统，进一步包括在所述导入器和所述球囊导管之间的加载器(140)，所述加载器具有带有远前端的管型的主体，所述远前端通过所述导入器架(102)并且所述导入器架(102)包含一系列阀(106、110、112)，这些阀在不同大小的医疗器具缺乏或存在下聚集在一起提供针对通过导入器(100)流出的血液的有效流体密封。
12.权利要求11的系统，其中所述加载器(140)包括一对与其平行延伸的、带内面搭钩脊(178)的附加的悬臂式指状物(176)，用于将所述加载器(140)固定到导入器(100)。
13.权利要求11的系统，其中所述加载器(140)包括环状加载器密封装置(180)，所述加载器(140)进一步与加载器帽(170)连接，所述加载器帽(170)具有与所述加载器(140)近端的外螺纹配合的内螺纹，其中所述螺纹的接合轴向压缩所述加载器密封装置(180)以提供流体紧密配合并且相对于所述球囊导管(54)轴向锁住所述加载器(140)。
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