CN100333704C - 心脏瓣膜治疗的方法和装置 - Google Patents
心脏瓣膜治疗的方法和装置 Download PDFInfo
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Abstract
本发明是一组设计用于改善心脏瓣膜功能的医用装置。所述的医用装置可以单独使用,也可以结合使用以补充损坏的瓣膜、替换损坏的瓣膜,或者改进损坏的瓣膜的功能。所述的医用装置包括瓣叶定位器、新环、新瓣叶,和支架。另外本发明还是手术治疗心脏瓣膜的新颖的方法。
Description
参照在审的在先专利申请
本专利申请要求由John A.Macoviak在2001年10月1日提交的序列号为60/326,590的在审的在先美国临时专利申请的优先权,该专利在此引为参照。
技术领域
本发明涉及改善心脏瓣膜的功能的方法和装置。更具体地,本发明涉及治疗二尖瓣反流的方法和装置。
技术背景
心脏瓣膜的开启和关闭主要由于压力差而发生的。例如二尖瓣的开启和关闭是由于左心房和左心室之间的压力差而发生的。在心室舒张期,心室舒张,从肺静脉的静脉回心血液流入左心房造成心房中的压力超过心室中的压力。结果,二尖瓣开启,让血液流进心室。随着在心室收缩期中心室收缩,室内压升高到心房中的压力以上并且推动二尖瓣关闭。
心室收缩产生的高压可能过度地推挤瓣叶并且使之翻转。脱垂是用于说明这种情况的术语。脱垂正常地由心室内的乳头肌收缩防止,所述的乳头肌由腱索(腱带)连接到二尖瓣瓣叶上。乳头肌的收缩与心室的收缩同时进行并且起保持健康的瓣叶在心室施加的峰值收缩压力下紧密关闭的作用。
瓣膜障碍可以由于腱索松驰和某些情况下撕裂造成。当腱索撕裂时,结果是连枷状瓣叶。还有,正常结构的瓣叶由于瓣膜环扩张可能不能正常工作。这种情况称作瓣膜环舒张并且一般由心肌衰竭产生。另外瓣膜可在出生时损伤或者由于获得性疾病损伤。
发明概述
本发明是一组设计用于改善心脏瓣膜功能的医用装置。所述的医用装置可以单独使用,也可组合使用以弥补损坏的瓣膜、替换损坏的瓣膜,或者改善损坏的瓣膜的功能。所述的医用装置包括瓣叶定位器、新环、新瓣叶,和支架。另外,本发明还包括手术治疗心脏瓣膜的新颖的方法。
附图说明
图1示出患者心脏100的后位斜剖视图。
图2示出患者心脏200的剖视图,带有脱垂的二尖瓣,所述脱垂的二尖瓣在心室收缩时不能够形成紧密的密封,并且从而使血液能够在心室收缩期回流进左心房。
图3示出患者心脏200的剖视图,带有脱垂的二尖瓣,所述脱垂的二尖瓣在心室收缩时不能够形成紧密的密封,并且从而使血液能够在心室收缩期回流进左心房,如箭头所示。
图4示出用于补充或替换天然的瓣叶的弹簧桥接新瓣叶的透视图。
图5示出本发明的一个实施方案的透视图,含有过桥540、张紧材料530、附着装置550,和基底520。另外,所述装置示出具有支架510。
图6示出图5所示实施方案在开启瓣膜位置的透视图。
图7示出图5和图6中所示实施方案位于心脏的左心房内的透视图。
图8和9示出图5和图6中所示实施方案位于心脏的左心房内的透视图。
图10示出具有避开肺静脉(未示出)的支架1010的本发明实施方案的透视图。
图11和12示出具有由前材料1110张紧的前过桥,和由后材料1120张紧的后过桥的双弹簧过桥新瓣叶的透视图。
图13示出没有连接到腱索上的损坏了的天然前瓣叶1310的透视图。
图14示出具有半缝合环1420的装置1400的透视图,带有起新环或者新瓣叶作用的膜1410。
图15示出具有全缝合环1530的装置1500的透视图,带有起新环或者新瓣叶作用的膜1510。
图16示出安置在心房内两天然二尖瓣叶顶部的瓣叶定位器1600的透视图。
图17示出安置在心房内两天然二尖瓣叶顶部的瓣叶定位器1700的透视图。
图18示出安置在心房内两天然二尖瓣叶顶部的瓣叶定位器1800的透视图。
图19示出安置在两天然二尖瓣叶顶部的瓣叶定位器1900的透视图。
图20示出图19所示的实施方案的侧视图。
图21示出图19所示的实施方案的透视图。
图22至26示出以导管为基础的经皮布设本发明实施方案的步骤顺序。
图27示出具有部分地填充心房的支架的本发明实施方案2700的透视图。
图28示出具有双新瓣叶2830和2840的本发明实施方案2800的透视图。
图29示出具有与天然瓣叶对置的瓣叶定位器2910以及绕心房迂回而不与肺静脉冲突的支架结构2920的本发明实施方案2900的透视图。
图30示出由形成瓣叶定位器和支架的连续的线或者管组成的本发明另一个实施方案3000的透视图。
图31示出本发明的郁金香形线状构形3100的透视图。
图32示出本发明的郁金香形线状构形3200的剖视图。
图33示出本发明的郁金香形带扭曲线状构形3300的剖视图。
图34示出左心房和左心室的剖视图。图左侧的箭头举例示出诸如瓣叶定位器、新瓣叶或新环之类的本发明实施方案,可与二尖瓣互动或者如果更换瓣叶时安置的三种不同方式。
图35示出带有拱托3500的网状瓣叶的透视图。
图36示出本发明的冠状构形3600的透视图。
图37示出原位在患者的左心房内的本发明的冠状构形3700的透视图。
图38示出具有均为完整的天然瓣叶3810和3820的心脏的剖视图。
图39示出带有本发明的一个实施方案3900的心脏的剖视图。
图40示出具有一个完整的二尖瓣瓣叶4010和一个切除或者失落的二尖瓣瓣叶的心脏的剖视图。
图41示出带有本发明的一个实施方案4100的心脏的剖视图。另外,所示的实施方案具有一个新瓣叶4110。
图42示出具有两个二尖瓣瓣叶都切除了的心脏的剖视图。
图43示出带有具两个新瓣叶的本发明一个实施方案4300的心脏的剖视图。
具体实施方式
图1示出患者心脏100的后位斜剖视图。示出四个心室中的两个,即左心房170和左心室140(未示出右心房和右心室)。左心房170充以从肺静脉流来的血液。然后在心室舒张期血液流经二尖瓣(也称为僧帽瓣,并且更一般地称为房室瓣)并且进入左心室140。在心室收缩期血液从左心室140射出经主动脉瓣150进入主动脉160。此时,二尖瓣应当关闭使血液不得回流进左心房。二尖瓣由两个瓣叶,即前瓣叶110和后瓣叶115组成,连接在腱索120上,腱索再在左心房140内连接到乳头肌130上。典型地,二尖瓣具有D字形的朝向主动脉瓣的前瓣叶110,带有新月形的后瓣叶115。瓣叶与心房170交于二尖瓣环190。
图2示出患者心脏200的剖视图,带有脱垂的二尖瓣,所述脱垂的二尖瓣在心室收缩期不能够形成紧密的密封,并且从而使血液能够在心室收缩期回流进左心房。前瓣叶220和后瓣叶225被鼓入左心房中,图中的箭头示出回流的方向。在其他原因中,回流可由于太长以致不能够防止瓣叶被鼓入心房的松驰的腱索210造成。结果瓣叶不能够形成紧密的密封,并且血液回流进心房。
图3示出患者心脏300的剖视图,带有连枷的二尖瓣320,所述连枷的二尖瓣320在心室收缩期不能够形成紧密的密封,并且从而使血液能够在心室收缩期回流进左心房,如箭头所示。在其它原因中,回流可由撕裂的腱索310造成。
图4示出用于补充或替换天然的瓣叶的弹簧桥接新瓣叶的透视图。图示的装置400由围绕二尖瓣环安置的基底420形成,然后关闭在前瓣叶上方以形成在前瓣叶上方的过桥430。过桥430可以是刚性、半刚性的或者挠性的。所述过桥可起弹簧的作用,并且从而动态地响应心脏内的压力差。过桥430可以具有张紧过桥430的张紧材料410。张紧材料410可以用一或多个附着装置440连接在装置400上(例如可以是缝合、胶粘或焊接在装置400上,或者可以在缠绕装置400时附着在其本身上)。张紧材料410可以用合成材料(例如薄镍钛诺、达克隆纤维、聚四氟乙烯或者说PTFE、硅酮或者聚氨酯)或者生物材料(例如人或动物心外膜)制造。装置400可以经皮地,经过胸(胸腔镜术)安放,或者使用心脏剖开手术安放。如果经皮安放,该装置可用超弹性材料(例如镍钛诺)制造,使之能够折叠和萎缩从而可以在导管中安放,并且在从导管中松脱以后可以接着自行膨胀。所述装置可以用缝合线或者其它的附着手段(即倒钩、钩、钉具等等)紧固到二尖瓣环上。
图5示出本发明的一个实施方案的透视图,含有过桥540、张紧材料530、附着装置550,和基底520。另外,所述装置示出具有支架510。优选地,支架510不与心房收缩冲突,而是随着心房收缩。这样,装置500可具有不均匀的挠性以改进其在心脏内的功能。在图中该支架从基底520上隆起,带有两个基本上平行的弧形线,它们连接形成在基底520上方的半圆环箍。支架510帮助把所述装置精确地安置在心房中,也帮助把所述装置固定在心房内。新瓣叶含有过桥540和张紧材料530,图示的新瓣叶处于关闭的瓣膜位置。
图6示出图5所示实施方案在开启瓣膜位置的透视图。
图7示出图5和图6中所示实施方案位于心脏的左心房内的透视图。
图8和9示出图5和图6中所示实施方案位于心脏左心房内的透视图。图8示出所述实施方案处于关闭瓣膜的位置,而图9示出所述实施方案处于开启瓣膜的位置。基底810的尺寸可以依据患者的需要而不同。
图10示出具有避开肺静脉(未示)的支架1010的本发明实施方案的透视图。
图11和12示出具有由前材料1110张紧的前过桥,和由后材料1120张紧的后过桥的双弹簧过桥新瓣叶的透视图。图中所示支架1130例举另一种设计。该实施方案还所示的基底具有突出于由瓣膜环形成的假想平面以下的夹具1140。图11示出关闭瓣膜位置中的双新瓣叶,而图12示出开启瓣膜位置中的双新瓣叶。
图13示出没有连接到腱索上的损坏了的天然前瓣叶1310的透视图。
图14示出具有半缝合环1420的装置1400的透视图,带有起新环或者新瓣叶作用的膜1410。当起新环的作用时,膜1410是相对地不动结构,盖住天然瓣叶之一,特别是损坏、失落或者无功能的瓣叶。新环起延伸天然环的作用,并且与剩余的功能性天然瓣膜接合以创立有功能的二尖瓣。当起新瓣叶的作用时,膜1410是可动的结构,它响应于血流运动,与天然瓣膜之一接合以创立有功能的二尖瓣。新瓣叶替换损坏、失落或者无功能的天然瓣叶的功能。装置1400经半缝合环1420连接在二尖瓣环上。该实施方案可以手术地附着在瓣膜环上和/或与支架结合,以利用基于导管的介入技术把该装置锚固在患者的心房中。
图15示出具有全缝合环1530的装置1500的透视图,带有起新环或者新瓣叶作用的膜1510。装置1500具有开口1520,经过与膜1510相对的缝合环1530用于血液流通。或者,该实施方案可以具有两个新瓣叶。该实施方案可以手术地附着在瓣膜环上和/或与支架结合,利用基于导管的介入技术把该装置锚固在患者的心房中。
图16示出安置在心房内两天然二尖瓣叶顶部的瓣叶定位器1600的透视图。该实施方案含有由径向支柱1620连接的外环1610和内环1630。瓣膜口的内部区域保留不被阻塞以用该实施方案流通血液。该实施方案可以手术地附着在瓣膜环上和/或与支架结合,以利用基于导管的介入技术把该装置锚固在患者的心房中。
图17示出安置在心房内两天然二尖瓣叶顶部的瓣叶定位器1700的透视图。该实施方案可以手术地附着在瓣膜环上和/或与支架结合,以利用基于导管的介入技术把该装置锚固在患者的心房中。
图18示出安置在心房内两天然二尖瓣叶顶部的瓣叶定位器1800的透视图。该实施方案可以手术地附着在瓣膜环上和/或与支架结合,以利用基于导管的介入技术把该装置锚固在患者的心房中。
图19示出安置在两天然二尖瓣叶顶部的瓣叶定位器1900的透视图。或者,瓣叶定位器可以设计只留置一个瓣叶,或者瓣叶的部分,这取决于患者的需要。该实施方案的外段具有锚着器1910,所述的锚着器1910沿心房壁分布应力,有助于防止磨损心房壁。该实施方案可以手术地附着在瓣膜环上和/或与支架结合,以利用基于导管的介入技术把该装置锚固在患者的心房中。
图20示出图19所示的实施方案的侧视图。
图21示出图19所示的实施方案的透视图。
图22至26示出以导管为基础的经皮布设本发明实施方案的步骤顺序。所述的布设技术也可以应用于其它的实施方案。首先,经外周静脉介入位置,譬如股静脉或者颈静脉,把引导线插入脉管系统中,或者变通地借助手术经右心房介入。图22示出经右和左心房之间的房间膈2220引入引导线2210。图示把引导线经下腔静脉2230引入进右心房。图23示出在引导线2310上推进导管2320。图24示出本发明的一个实施方案2400在取出引导线2310以后从导管上被松开。或者,可以用引导线定位所述的装置。图25示出具有另外特征的本发明的一个实施方案,定位在肺静脉中的环形孔2500有助于把所述装置安放在心房腔内。所述的环形孔2500可以在引导线上推进。图26所示的本发明实施方案2600安置在左心房内。装置2600可以使用导管布设的抓握装置2610安置或者重新安置在心房内。
图27示出具有部分填充心房的支架的本发明实施方案2700的透视图。
图28示出具有双新瓣叶2830和2840的本发明实施方案2800的透视图。所述装置含有支架2810、环形基底2820和新瓣叶2830和2840。新瓣叶补充或替代天然瓣叶,并且起单向阀的作用让血液从心房流向心室,并且防止血液从心室流向心房。此目的的实现是由于新瓣叶结构与天然瓣叶结构相似。
图29示出本发明实施方案2900的透视图,其具有与天然瓣叶对置的瓣叶定位器2910以及绕心房迂回而不与肺静脉冲突的支架结构2920。瓣叶定位器2910防止瓣叶由于心室收缩期的压差而脱垂进心房,从而改善了二尖瓣的关闭并且降低回流。
图30示出本发明另一个实施方案3000的透视图,其由形成瓣叶定位器和支架的连续的线或者管组成。支架的几何状态使得它在心房内向上螺旋。装置3000由于支架在心房内膨胀并且经受心壁压力而固定在位。左定位器通过其连接到支架上在天然瓣叶上方固定在位,并且该瓣叶定位器起阻止天然瓣叶承受脱垂的作用。此外,促进组织生长的涂层可有助于支架在心房内固定的过程。然而装置3000的瓣叶定位器部分可受益于抑制组织生长的涂层,从而让天然的瓣叶能够使血液流入心室中。
图31示出本发明的郁金香形线状构形3100的透视图。
图32示出本发明的郁金香形线状构形3200的剖视图。该图示出与天然的瓣叶3220和3210进行接触以防止脱垂的装置3200。装置3200含有起防止天然瓣叶3210和3220在心室收缩时被鼓入心房中的作用的瓣叶留置部分。该瓣叶留置部分被直接安置在天然瓣叶的上方。在此实施方案中,装置3200的瓣叶留置方面在图中示出与装置的支架部分整体地形成。然而在其它的实施方案中,瓣叶定位器和支架可以是独立的结构,它们可以为单独使用或者结合使用分开地布设。
图33示出本发明的郁金香形带有扭曲线状构形3300的剖视图。该扭曲的方面使得所述装置能够经扭曲而缩短以减少纵向弹簧常数。装置3300含有起防止天然的瓣叶在心室收缩时被鼓入心房中的作用的瓣叶留置部分。该瓣叶留置部分被直接安置在天然瓣叶的上方。在此实施方案中,装置3300的瓣叶留置方面在图中示出与装置的支架部分整体地形成。然而在其它的实施方案中,瓣叶定位器和支架可以是独立的结构,它们可以为单独使用或者结合使用分开地布设。
图34示出左心房和左心室的剖视图。图左侧的箭头举例地示出诸如瓣叶定位器、新瓣叶、或新环之类的本发明实施方案,可与二尖瓣互动或者如果更换瓣叶时安置的三种不同方式。换言之,本发明的一个实施方案可以位于由二尖瓣的环形成的平面上,如中间的箭头3410所示。还有,发明的一个实施方案可以位于由二尖瓣的环形成的平面上方或者下方,如分别由上方的箭头3400和下方的箭头3420所示。另外,图34还用于示出当本发明的这些部件被构形成弹簧过桥时可能的运动,所述弹簧过桥张紧二尖瓣环和主动地随着瓣叶运动。可以把弹簧过桥构形得被偏置在开启瓣膜的位置,并且由于心室内的压力上升而受迫关闭。或者,不把所述弹簧过桥偏置得开启或者关闭,而是简单地响应压差运动。还有,也可以把弹簧过桥偏置在关闭位置。
图35示出带有拱托3500的网状瓣叶的透视图。该实施方案含有支架3510和瓣叶定位器3520。该实施方案的瓣膜孔3530的内部区域保留开启以便于血液在心室之间流动。瓣叶定位器3520防止天然的瓣叶在心室收缩时被鼓入心房中。支架3510把心壁压力传送到瓣叶定位器,激励瓣叶定位器保持处在天然瓣叶的上方。
图36示出本发明的冠状构形3600的透视图。该实施方案可以用作支架,瓣叶定位器或者其它的瓣膜加强装置可以附着或者连接于其上。
图37示出原位在患者左心房内的本发明的冠状构形3700的透视图。
图38示出具有均为完整的天然瓣叶3810和3820的心脏的剖视图。
图39示出带有本发明一个实施方案3900的心脏的剖视图。
图40示出具有一个完整的二尖瓣瓣叶4010和一个切除或者失落的二尖瓣瓣叶的心脏的剖视图。切除的瓣叶的腱索4020在图中示出是间断的。
图41示出带有本发明实施方案4100的心脏的剖视图。另外,所述的实施方案具有一个新瓣叶4100。所述的新瓣叶4100可以是刚性的、半刚性的或者挠性的。
图42示出具有两个二尖瓣瓣叶都切除了的心脏的剖视图。腱索4210在图中示出是间断的。
图43示出带有两个新瓣叶的本发明一个实施方案4300的心脏的剖视图。
这些装置可经开心手术、经胸、或经远端血管安放到心脏。经远端血管递送的例子包括利用引导线和导管。它们可以经上腔静脉或下腔静脉(经管路地、经外周静脉插入位置,譬如股静脉或者颈静脉)推进至右心房中,或者经主动脉推进到左心室中。左心房可以从右心房经房间膈抵达。或者,可以经外周动脉插入位置,譬如股动脉获得通路用于经腔方法通过二尖瓣从左心室通到左心房。可以用超声波技术判断患者是否经受回流并且可以使用各种成像技术定位所述装置。
所示装置可以使用倒钩、钉、胶、磁体等等锚着在左心房内。另外,所述的装置可以涂复各种材料以促进(达克隆)或抑制(肝素)装置周围的组织生长,以防止血栓,或者涂复其它所希望的材料以激励其它合意的特性。还可以在瓣的对(心室)侧进行锚着。
尽管在此以示例的实施方案和实施本发明的最佳方式说明了本发明,然而本领域内普通技术人员可以对本发明的各种实施方案、适应和变化进行许多修改、改进和亚组合而不偏离本发明的精神和范围将是一目了然的。
Claims (4)
1.医用装置,包含心脏植入物,所述植入物的尺寸和构造做成通过血管内进入路径定位于天然心脏二尖瓣环平面上方的左心房中,所述路径从右心房穿过隔膜进入左心房,所述植入物包括部分,所述部分的大小和构造做成跨越天然心脏二尖瓣环上方平面内的天然心脏二尖瓣环以与心脏二尖瓣小叶的运动相互作用从而影响心脏二尖瓣的功能。
2.如权利要求1所述的医用装置,其中所述部分的尺寸和构造做成改变天然心脏二尖瓣环的形状。
3.如权利要求1所述的医用装置,其中所述心脏植入物至少部分包括镍钛诺、达克隆纤维、聚四氟乙烯、硅酮、聚氨酯、人类心包膜或动物心包膜。
4.如权利要求1所述的医用装置,其中所述心脏植入物至少部分包括超弹性的材料。
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- 2002-10-01 CA CA002462254A patent/CA2462254A1/en not_active Abandoned
- 2002-10-01 WO PCT/US2002/031376 patent/WO2003028558A2/en active Application Filing
- 2002-10-01 EP EP02800430A patent/EP1434542A2/en not_active Withdrawn
-
2003
- 2003-10-28 US US10/695,433 patent/US7291168B2/en not_active Expired - Lifetime
-
2005
- 2005-08-25 HK HK05107461A patent/HK1073423A1/xx not_active IP Right Cessation
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2007
- 2007-10-25 US US11/977,493 patent/US20080140190A1/en not_active Abandoned
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN2135346Y (zh) * | 1992-09-12 | 1993-06-09 | 中国人民解放军第四军医大学第一附属医院 | 可塑性二尖瓣成型环 |
CN1131384A (zh) * | 1993-08-13 | 1996-09-18 | 让-保罗·库蒂尔 | 可植心瓣 |
CN1223560A (zh) * | 1996-06-24 | 1999-07-21 | 阿迪亚姆医药技术有限及两合公司 | 人造心脏瓣膜 |
CN1223562A (zh) * | 1996-06-24 | 1999-07-21 | 阿迪亚姆医药技术有限及两合公司 | 人造二尖瓣心脏瓣膜 |
WO2001019292A1 (en) * | 1999-09-17 | 2001-03-22 | Cardiac Concepts, Inc. | Mitral valve annuloplasty ring and method |
Also Published As
Publication number | Publication date |
---|---|
CN101108144A (zh) | 2008-01-23 |
US20080140190A1 (en) | 2008-06-12 |
JP2005504577A (ja) | 2005-02-17 |
US20040138745A1 (en) | 2004-07-15 |
AU2002362442B2 (en) | 2008-08-07 |
US7291168B2 (en) | 2007-11-06 |
CA2462254A1 (en) | 2003-04-10 |
WO2003028558A2 (en) | 2003-04-10 |
HK1073423A1 (en) | 2005-10-07 |
JP4458845B2 (ja) | 2010-04-28 |
CA2455444A1 (en) | 2003-04-10 |
EP1434542A2 (en) | 2004-07-07 |
CN1610529A (zh) | 2005-04-27 |
WO2003028558A8 (en) | 2003-10-30 |
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