CN106214288B - 用于向递送系统上装载假体的方法和设备 - Google Patents
用于向递送系统上装载假体的方法和设备 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
本发明公开了一种用于向递送系统上装载假体的装置,该装置包括具有中心孔的第一壳体。可以径向向内致动所述第一壳体上的一个或多个致动器,以便选择性地压缩安置在中心孔中的假体的分立部分。
Description
本申请是2013年05月30日提交的发明名称为“用于向递送系统上装载假体的方法和设备”的第201380040510.5号(国际申请号PCT/CA2013/000530)中国专利申请的分案申请。
交叉引用
本申请为提交于2012年5月30日的美国临时专利申请No.
61/653,273(代理人案卷号42194-706.101)的非临时申请,并要求其权益;上述申请的全部内容通过引用并入于此。
发明背景
1.发明领域。本发明总体上涉及医疗装置和方法,且更具体地涉及用于向递送系统上装载假体的装置和方法。所述假体可以是任何装置,但在优选的实施方式中用于治疗瓣膜功能不全,诸如二尖瓣关闭不全,亦称为二尖瓣反流。所述递送系统可以是用于通过传统的外科植入法或者通过创伤较小的经皮导管或微创经心尖法来递送假体的任何系统。
脊椎动物的心脏分为四个腔室,并带有四个瓣膜(二尖瓣、主动脉瓣、肺动脉瓣和三尖瓣),它们确保由心脏泵送的血液在向前的方向上流过心血管系统。健康心脏的二尖瓣阻止血液从心脏的左心室向左心房中回流,且该二尖瓣包括当左心室收缩时闭合的两片柔性小叶(前小叶和后小叶)。所述小叶附接到纤维环,且它们的自由边通过瓣下腱索系至左心室中的乳头肌以防止它们在左心室收缩过程中脱垂入左心房中。
各种心脏疾病或退行性病变可导致二尖瓣器的这些部分中的任何部分的功能障碍,导致二尖瓣变得异常缩窄或扩张,或者允许血液从左心室回漏(亦称为反流)至左心房中。任何这样的损伤都会危害心脏的完好性,并且可能会使人衰弱或危及生命。
因此,已开发出许多外科方法和装置来治疗二尖瓣功能障碍,包括用于替换、修复或重塑天然二尖瓣器的心内直视外科技术,以及用以改变天然二尖瓣解剖结构的诸如瓣环成形术环等各种假体装置的外科植入。近来,已开发出用于递送置换二尖瓣组装件的创伤较小的经导管技术。在此类技术中,假体瓣膜一般以卷曲状态安装在柔性导管的末端并经患者的血管或身体推进,直至该瓣膜抵达植入部位。继而,假体瓣膜在有缺陷的天然瓣膜的部位处扩张至其功能尺寸。
尽管这些装置和方法是针对瓣膜功能不全的有前途的疗法,但它们可能难以递送,且难以装载至递送系统上。因此,期望提供用于将假体与递送系统相耦合的改进的装置和方法。下文公开的装置和方法将会满足这些目标中的至少一些目标。
2.背景技术描述。举例而言,公开内容通过引用并入于此的PCT国际专利号PCT/US2008/0544 0(以PCT国际公开号WO2008/103722公开)描述了一种经导管二尖瓣假体,其包括:弹性环;多个小叶膜,它们与所述环相对地安装以允许血液沿一个方向从其中流过;以及多个组织接合定位元件,它们相对于所述环可移动地安装且尺寸设定为包握心脏瓣膜环、心脏瓣膜小叶和/或心脏壁的解剖结构。每个定位元件限定相应的近端、中间和远端组织接合区,它们被协同地配置和设定尺寸以便同时接合解剖结构的组织的单独的对应区域,且所述定位元件可包括相应的第一、第二和第三细长组织穿刺元件。瓣膜假体还可包括相对于弹性环安装的裙部,用于密封瓣膜假体的周边以防血液在瓣膜假体周围逆流。
公开内容通过引用并入于此的PCT国际专利号PCT/US2009/041754(以PCT国际公开号WO2009/134701公开)描述了一种假体二尖瓣组装件,其包括具有张开的上端和渐缩部以适配天然二尖瓣轮廓的锚固件或外支撑框架,以及安装在其中的基于组织的单向瓣膜。该组装件适于径向向外扩张并与天然心脏组织相接触以形成压配合,且该组装件还包括张紧构件,该张紧构件将瓣膜组装件的小叶锚固至心脏上的合适位置以发挥假体腱索的功能。
还已知利用卡爪结构将假体附接到心脏的假体二尖瓣组装件(例如,参见Hermann等人的美国专利申请公开号US2007/0016286,其公开内容通过引用并入于此),这样的假体二尖瓣组装件依赖于轴向而非径向夹持力的施加,以便促进假体相对于天然解剖结构的自定位和自锚固。
作为二尖瓣反流的疗法而提出的另一方法是外科双孔成形(bow tie)法,其最近已适合基于微创导管的治疗,其中使用植入物将瓣膜小叶夹在一起。该手术更充分地公开于科学和专利文献中,诸如公开于St.Goar等人的美国专利号6,629,534中,该文献的全部内容通过引用并入本文。
其他相关的公开文献包括Carpentier等人的美国专利公开号2011/0015731和Lane等人的WO 2011137531。虽然这些装置和方法中的一些装置和方法是有前途的,但仍然存在对于将会进一步允许更精确地定位假体瓣膜并且还将会更牢固地将瓣膜锚固到位的改进的装置和方法的需求。除了需要改进的装置之外,还需要用于将装置装载至其相应的递送系统上的改进的递送系统和改进的工具或者装置和方法。本文所公开的示例性实施方式将会满足这些目标中的至少一些目标。
发明内容
本发明总体上涉及医疗装置和方法,且更具体地涉及用于向递送系统上装载假体的装置和方法。所述假体可以是任何装置,但在优选的实施方式中用于治疗瓣膜功能不全,诸如二尖瓣关闭不全,亦称为二尖瓣反流。所述递送系统可以是用于通过传统的外科植入法或者通过创伤较小的经皮导管或微创经心尖法来递送假体的任何系统。尽管本公开着眼于用于将假体装载到递送系统上的夹具,但并不旨在仅限于此。本文所公开的假体瓣膜还可用于治疗其他身体瓣膜,包括其他心脏瓣膜或静脉瓣膜。示例性的心脏瓣膜包括主动脉瓣、三尖瓣或肺动脉瓣。本文所公开的装载装置可以用于将任何假体装载到任何递送系统上。
在本发明的第一方面,一种用于向递送系统上装载假体的装置包括第一壳体,该第一壳体包括第一入口、第一出口以及在它们之间延伸的第一中心孔(bore)。所述第一壳体具有一个或多个配置用于径向向内或向外致动的致动器,并且所述一个或多个致动器适于当所述假体被安置在所述第一中心孔中时选择性地径向向内压缩所述假体的分立部分,而同时所述假体的相邻部分保持不被所述一个或多个致动器所压缩。
所述第一中心孔可包括恒定直径区域或第一渐缩区域,该第一渐缩区域适于当所述假体从中穿过时使所述假体从第一初始直径径向收缩至较小直径。所述一个或多个致动器可包括三个致动器,所述三个致动器大约每隔120度地周向安置在所述第一壳体周围。所述一个或多个致动器能够可操作地耦合在一起,使得它们被同时致动。所述装置可进一步包括可与所述第一壳体螺纹接合的套环。旋转所述套环对所述一个或多个致动器加以致动。所述一个或多个致动器可包括弹簧加载式致动器,所述弹簧加载式致动器被偏斜(bias)以返回到从所述第一中心孔径向向外安置的位置。所述第一壳体可进一步包括用于接合相邻壳体的多个接合元件。所述装置还可包括可释放地与所述第一壳体相接合的支撑元件。所述内支撑元件可被配置用于支撑所述假体的内表面。
所述装置可进一步包括可首尾相接地与所述第一壳体相耦合的第二壳体。所述第二壳体可包括第二入口、第二出口以及在它们之间延伸的第二中心孔。所述第二中心孔可具有第二渐缩区域,所述第二渐缩区域适于当推进所述假体穿过该第二中心孔时使所述假体从第二初始直径径向收缩至第二较小直径。所述第二中心孔可进一步包括第二恒定直径区域,该第二恒定直径区域与所述第一中心孔连通并位于其近侧。所述第二中心孔可进一步包括圆角区域,该圆角区域安置在所述第二渐缩区域与所述第二恒定直径区域之间。所述第二中心孔可至少部分地为圆柱形。所述第二壳体可包括用于可释放地将所述第二壳体与相邻壳体相接合的多个接合元件,或者用于接纳相邻壳体上的接合元件的多个接合容器。所述多个接合元件可包括三个接合耳片,所述三个接合耳片大约每隔120度地周向布置在所述第一壳体周围。所述假体经过所述第二中心孔的穿通可将所述假体塑形成具有圆形横截面。
所述装置可进一步包括可首尾相接地与所述第一壳体或第二壳体相耦合的第三壳体。所述第三壳体可包括第三入口、第三出口以及在它们之间延伸并与所述第一中心孔或所述第二中心孔连通的第三中心孔。所述第三中心孔可具有第三渐缩区域,所述第三渐缩区域适于当推进所述假体穿过该第三中心孔时使所述假体从第三直径径向收缩至小于该第三直径的直径。所述第三中心孔可进一步包括第三恒定直径区域,该第三恒定直径区域与所述第三渐缩区域连通并位于其远侧。所述第三中心孔还可包括圆角区域(filletedregion),该圆角区域安置在所述第三渐缩区域与所述第三恒定直径区域之间。所述第三中心孔可至少部分地为圆柱形。所述第三壳体可包括用于可释放地接合相邻壳体的多个接合元件。所述第三壳体可包括多个接合容器,所述多个接合容器用于接纳相邻壳体上的接合元件。所述多个接合元件可包括三个接合耳片,所述三个接合耳片大约每隔120度地周向布置在所述第一壳体周围。所述假体经过所述第三中心孔的穿通可将所述假体塑形成具有圆形横截面。
所述假体可包括假体心脏瓣膜,并且可包括多个锚固耳片,并且其中所述一个或多个致动器的致动适于径向向内移动所述多个锚固耳片。所述多个锚固耳片可适于可释放地与递送导管上的固定特征相接合。所述多个锚固耳片可包括假体心脏瓣膜上的连合杆。
在本发明的另一方面,一种用于向递送系统上装载假体的系统除假体心脏瓣膜和递送装置之外包括上述的装载装置。
在本发明的又一方面,一种用于向递送系统上装载假体的方法包括:提供假体瓣膜,该假体瓣膜具有多个与之耦合的连合杆,其中所述假体瓣膜包括无偏斜直径;以及在选定的分立区域中减小所述假体瓣膜的所述无偏斜直径,所述选定的分立区域包括所述连合杆。所述方法还包括将减小直径的假体瓣膜装载到递送装置上。
减小所述假体瓣膜的所述无偏斜直径可包括致动第一壳体上的一个或多个致动器,其中所述一个或多个致动器可选择性地接合所述假体瓣膜的分立区域。所述方法可进一步包括使所述假体瓣膜穿过所述第一壳体中的中心通道的恒定直径部分。致动所述一个或多个致动器可包括径向向内按下一个或多个销钉或指状体,以接合所述假体瓣膜的所述分立区域。所述分立区域可径向向内移动成减小的外形。按下可包括同时按下所述一个或多个销钉或指状体(finger)。
所述方法可进一步包括将所述假体瓣膜的直径从所述无偏斜直径减小至小于所述无偏斜直径的第一直径。将所述假体瓣膜的直径从所述无偏斜直径减小至所述第一直径可包括使所述假体瓣膜穿过渐缩的中心通道。使所述假体瓣膜穿过所述渐缩的中心通道可包括推动或拉动所述假体瓣膜从中穿过。使所述假体瓣膜穿过所述渐缩的中心通道可包括将所述假体瓣膜塑形成具有圆形横截面。
所述方法可进一步包括将所述假体瓣膜的直径从所述第一直径减小至小于所述第一直径的第二直径。将直径从所述第一直径减小至所述第二直径可包括使所述假体瓣膜穿过第二渐缩的中心通道。使所述假体瓣膜穿过所述第二渐缩的中心通道可包括推动或拉动所述假体瓣膜从中穿过。
所述递送装置可包括可滑动地安置在其上的内轴和外轴,并且装载所述减小直径的假体瓣膜可包括将所述假体瓣膜安置在所述内轴与所述外轴之间。装载所述减小直径的假体瓣膜可包括可释放地将所述连合杆与所述递送装置相接合。
所述假体瓣膜可由镍钛合金制成,并且所述方法可进一步包括将所述假体瓣膜冷却至低于或等于所述假体瓣膜的奥氏体终止温度的温度。冷却所述假体瓣膜可包括在冷盐水中冷却所述假体瓣膜。所述假体瓣膜的直径可在第一壳体中从所述无偏斜直径减小至所述第一直径,并且所述假体瓣膜的直径可在第二壳体中从所述第一直径减小至所述第二直径,并且所述方法可进一步包括将所述第一壳体与所述第二壳体相耦合。在所述直径已经减少至所述第一直径之后,可以将所述第一壳体与所述第二壳体彼此解耦。所述方法还可包括用支撑元件来支撑所述假体的内表面。
在涉及附图的以下描述中进一步详细地描述这些实施方式和其他实施方式。
具体而言,本发明涉及:
1.一种用于向递送系统上装载假体的装置,所述装置包括:
第一壳体,其包括第一入口、第一出口以及在该第一入口和第一出口之间延伸的第一中心孔,并且其中所述第一壳体具有一个或多个配置用于径向向内或向外致动的致动器,所述一个或多个致动器适于当所述假体被安置在所述第一中心孔中时选择性地径向向内压缩所述假体的分立部分,而同时所述假体的相邻部分保持不被所述一个或多个致动器压缩。
2.根据段1所述的装置,其中所述第一中心孔包括恒定直径区域。
3.根据段1所述的装置,其中所述第一中心孔包括第一渐缩区域,该第一渐缩区域适于当所述假体从中穿过时使所述假体从第一初始直径径向收缩至较小直径。
4.根据段1所述的装置,其中所述一个或多个致动器包括三个致动器,所述三个致动器大约每隔120度地周向安置在所述第一壳体周围。
5.根据段1所述的装置,其中所述一个或多个致动器可操作地耦合在一起,使得所述一个或多个致动器被同时致动。
6.根据段1所述的装置,进一步包括可与所述第一壳体螺纹接合的套环,并且其中旋转所述套环以对所述一个或多个致动器加以致动。
7.根据段1所述的装置,其中所述一个或多个致动器包括弹簧加载式致动器,所述弹簧加载式致动器被偏斜以返回到从所述第一中心孔径向向外安置的位置。
8.根据段1所述的装置,其中所述第一壳体进一步包括用于接合相邻壳体的多个接合元件。
9.根据段1所述的装置,进一步包括可释放地与所述第一壳体相接合的内支撑元件,所述内支撑元件被配置用于支撑所述假体的内表面。
10.根据段1所述的装置,进一步包括可首尾相接地与所述第一壳体相耦合的第二壳体,其中所述第二壳体包括第二入口、第二出口以及在该第二入口和第二出口之间延伸的第二中心孔,所述第二中心孔具有第二渐缩区域,所述第二渐缩区域适于当所述假体被推进穿过该第二中心孔时使所述假体从第二初始直径径向收缩至第二较小直径。
11.根据段10所述的装置,其中所述第二中心孔进一步包括第二恒定直径区域,该第二恒定直径区域与所述第一中心孔连通并位于其近侧。
12.根据段11所述的装置,其中所述第二中心孔进一步包括圆角区域,该圆角区域安置在所述第二渐缩区域与所述第二恒定直径区域之间。
13.根据段10所述的装置,其中所述第二中心孔至少部分地为圆柱形。
14.根据段10所述的装置,其中所述第二壳体包括多个接合元件,所述多个接合元件用于可释放地将所述第二壳体与相邻壳体相接合。
15.根据段10所述的装置,其中所述第二壳体包括多个接合容器,所述多个接合容器用于接纳相邻壳体上的接合元件。
16.根据段14所述的装置,其中所述多个接合元件包括三个接合耳片,所述三个接合耳片大约每隔120度地周向布置在所述第一壳体周围。
17.根据段10所述的装置,其中所述假体经过所述第二中心孔的穿通将所述假体塑形成具有圆形横截面。
18.根据段1所述的装置,进一步包括可首尾相接地与所述第一壳体或第二壳体相耦合的第三壳体,所述第三壳体包括第三入口、第三出口以及在该第三入口和第三出口之间延伸并与所述第一中心孔或所述第二中心孔连通的第三中心孔,所述第三中心孔具有第三渐缩区域,所述第三渐缩区域适于当所述假体被推进穿过该第三中心孔时使所述假体从第三直径径向收缩至小于该第三直径的直径。
19.根据段18所述的装置,其中所述第三中心孔进一步包括第三恒定直径区域,该第三恒定直径区域与所述第三渐缩区域连通并位于其远侧。
20.根据段19所述的装置,其中所述第三中心孔进一步包括圆角区域,该圆角区域安置在所述第三渐缩区域与所述第三恒定直径区域之间。
21.根据段18所述的装置,其中所述第三中心孔至少部分地为圆柱形。
22.根据段18所述的装置,其中所述第三壳体包括用于可释放地接合相邻壳体的多个接合元件。
23.根据段18所述的装置,其中所述第三壳体包括多个接合容器,所述多个接合容器用于接纳相邻壳体上的接合元件。
24.根据段22所述的装置,其中所述多个接合元件包括三个接合耳片,所述三个接合耳片大约每隔120度地周向布置在所述第一壳体周围。
25.根据段18所述的装置,其中所述假体经过所述第三中心孔的穿通将所述假体塑形成具有圆形横截面。
26.根据段1所述的装置,其中所述假体包括假体心脏瓣膜。
27.根据段1所述的装置,其中所述假体包括多个锚固耳片,并且其中所述一个或多个致动器的致动适于径向向内移动所述多个锚固耳片。
28.根据段27所述的装置,其中所述多个锚固耳片适于可释放地与递送导管上的固定特征相接合。
29.根据段27所述的装置,其中所述假体包括假体心脏瓣膜,并且所述多个锚固耳片包括所述假体心脏瓣膜的连合杆。
30.一种用于向递送系统上装载假体的系统,所述系统包括:
根据段1所述的装置;
假体心脏瓣膜;以及
递送装置。
31.一种用于向递送系统上装载假体的方法,所述方法包括:
提供假体瓣膜,该假体瓣膜具有多个与之耦合的连合杆,其中所述假体瓣膜包括无偏斜直径;
在选定的分立区域中减小所述假体瓣膜的所述无偏斜直径,所述选定的分立区域包括所述连合杆;以及
将减小直径的假体瓣膜装载到递送装置上。
32.根据段31所述的方法,其中减小所述假体瓣膜的所述无偏斜直径包括致动第一壳体上的一个或多个致动器,所述一个或多个致动器选择性地接合所述假体瓣膜的分立区域。
33.根据段32所述的方法,进一步包括使所述假体瓣膜穿过所述第一壳体中的中心通道的恒定直径部分。
34.根据段32所述的方法,其中致动所述一个或多个致动器包括径向向内按下一个或多个销钉或指状体,以接合所述假体瓣膜的所述分立区域,所述分立区域径向向内移动成减小的外形。
35.根据段34所述的方法,其中按下包括同时按下所述一个或多个销钉或指状体。
36.根据段31所述的方法,进一步包括将所述假体瓣膜的直径从所述无偏斜直径减小至小于所述无偏斜直径的第一直径。
37.根据段36所述的方法,其中将所述假体瓣膜的直径从所述无偏斜直径减小至所述第一直径包括使所述假体瓣膜穿过渐缩的中心通道。
38.根据段37所述的方法,其中使所述假体瓣膜穿过所述渐缩的中心通道包括推动或拉动所述假体瓣膜从所述渐缩的中心通道中穿过。
39.根据段37所述的方法,其中使所述假体瓣膜穿过所述渐缩的中心通道包括将所述假体瓣膜塑形成具有圆形横截面。
40.根据段36所述的方法,进一步包括将所述假体瓣膜的直径从所述第一直径减小至小于所述第一直径的第二直径。
41.根据段40所述的方法,其中将所述假体瓣膜的直径从所述第一直径减小至所述第二直径包括使所述假体瓣膜穿过第二渐缩的中心通道。
42.根据段41所述的方法,其中使所述假体瓣膜穿过所述第二渐缩的中心通道包括推动或拉动所述假体瓣膜从所述第二渐缩的中心通道中穿过。
43.根据段31所述的方法,其中所述递送装置包括可滑动地安置在其上的内轴和外轴,并且其中装载所述减小直径的假体瓣膜包括将所述假体瓣膜安置在所述内轴与所述外轴之间。
44.根据段31所述的方法,其中装载所述减小直径的假体瓣膜包括可释放地将所述连合杆与所述递送装置相接合。
45.根据段31所述的方法,其中所述假体瓣膜由镍钛合金制成,并且所述方法进一步包括将所述假体瓣膜冷却至低于或等于所述假体瓣膜的奥氏体终止温度的温度。
46.根据段45所述的方法,其中冷却所述假体瓣膜包括在冷盐水中冷却所述假体瓣膜。
47.根据段40所述的方法,其中所述假体瓣膜的直径在第一壳体中从所述无偏斜直径减小至所述第一直径,并且其中所述假体瓣膜的直径在第二壳体中从所述第一直径减小至所述第二直径,并且其中所述方法进一步包括将所述第一壳体与所述第二壳体相耦合。
48.根据段47所述的方法,进一步包括在所述直径已经减少至所述第一直径之后,将所述第一壳体从所述第二壳体解耦。
49.根据段31所述的方法,进一步包括用支撑元件来支撑所述假体的内表面。
援引并入
本说明书中所提及的所有出版物、专利和专利申请均通过引用并入本文,程度如同具体地和个别地指出要通过引用来并入每一单个出版物、专利或专利申请。
附图说明
本发明的新颖特征在随附权利要求书中具体阐述。通过参考以下对其中利用到本发明原理的示例说明性实施方式加以阐述的详细描述和附图,将会对本发明的特征和优点获得更好的理解;在附图中:
图1是心脏的左心室的示意图,图中用箭头示出心缩期的血液流动。
图2是心脏的左心室的示意图,其具有二尖瓣中的脱垂小叶。
图3是患有心肌病的患者体内心脏的示意图,其中心脏扩张且小叶不相接。
图3A示出瓣膜小叶的正常闭合。
图3B示出瓣膜小叶的异常闭合。
图4图示了具有受损的乳头肌的心脏左心室中的二尖瓣反流。
图5A-图5B图示了二尖瓣的解剖结构。
图6图示了假体心脏瓣膜中的无覆盖框架的示例性实施方式,其中所述框架被展平和铺开。
图7图示了假体心脏瓣膜中的无覆盖框架的另一示例性实施方式,其中所述框架被展平和铺开。
图8图示了假体心脏瓣膜中的无覆盖框架的又一示例性实施方式,其中所述框架被展平和铺开。
图9A图示了假体心脏瓣膜中的无覆盖框架在其扩张之后的透视图。
图9B图示了图9A中的实施方式的俯视图。
图10图示了图9A的框架具有覆盖物从而形成假体心脏瓣膜。
图11A-图11D图示了用于经心尖递送假体心脏瓣膜的递送系统的示例性实施方式。
图12A-图12L图示了植入假体心脏瓣膜的示例性方法。
图13A-图13L图示了植入假体心脏瓣膜的另一示例性方法。
图14是用于具有连合部的假体瓣膜向递送系统中的装载的示例性装载系统的透视图。
图15是图14中的装载系统的侧视图。
图16是图14中的装载系统的剖视图。
图17是图14中的装载系统的局部分解侧视图。
图18A是图14中的装载系统在未致动配置下的端视图。
图18B是图14中的装载系统在致动配置下的端视图。
图19是假体的局部剖视图,其连合部被插入到图14的装载系统的第一级中。
图20是图19中的假体的局部剖视图,该假体从图14的装载系统的第一级行进至第二级。
图21是图19中的假体的局部剖视图,该假体行进经过图14的装载系统的第二级。
图22是图19中的假体的局部剖视图,该假体从图14中的装载系统的第二级行进至第三级。
图23是图19中的假体的局部剖视图,该假体被定位在图14的装载系统的第三级内。
图24是图19中的假体的局部剖视图,该假体被定位在图14的装载系统的第三级内,且还有递送系统与装载系统相接合。
图25是图19中的假体在图14的装载系统的致动之后的局部剖视图。
图26A是图14中的装载系统的端视图,图中示出处于收缩但未挠曲配置中的假体。
图26B是图14中的装载系统的端视图,并有处于收缩并挠曲配置中的假体。
图27图示了装载系统的另一示例性实施方式。
图28A-图28B图示了致动之前的图27的装载系统。
图29A-图29B图示了致动之后的图27的装载系统。
图30-图33图示了装载系统的又一示例性实施方式。
具体实施方式
现将参考附图来描述公开的装置、递送系统和方法的具体实施方式。这些详细描述中的内容并不旨在暗示任何特定组件、特征或步骤对于本发明而言是不可或缺的。
心脏解剖结构。图1中图示了处于心缩期的正常心脏H的左心室LV。左心室LV正在收缩并且血液在箭头方向上通过主动脉瓣AV、即三尖瓣向外流动。由于二尖瓣被构造成当左心室中的压强高于左心房LA中的压强时阻止回流的“止回阀”,因此阻止了通过二尖瓣MV的血液回流或“反流”。如图1中所示,二尖瓣MV包括一对小叶,所述小叶具有均匀接触以便闭合的自由边FE。小叶LF的相对端沿着被称为环AN的环形区附接到周围的心脏结构。小叶LF的自由边FE通过腱索CT(在本文也称为索)紧固至左心室LV的下部,该腱索包括紧固在每个瓣膜小叶LF的底面上的多个分支腱。索CT进而附接至从左心室下部和室间隔IVS向上延伸的乳头肌PM。
现参考图2-图4,心脏中的若干结构缺陷可能导致二尖瓣反流。如图2中所示,断裂的腱索RCT可能因经由腱索传递至小叶的张力不足而导致瓣膜小叶LF2脱垂。尽管另一小叶LF1保持正常外形,但两个瓣膜小叶不能正确地接触,因而会发生如箭头所示的从左心室LV向左心房LA中的泄漏。
反流还发生在患有心肌病的患者身上,其中,心脏如图3中所示地扩张,而增大的尺寸阻止了瓣膜小叶LF正确接触。心脏的增大导致二尖瓣环变大,使得自由边FE无法在心缩期相接触。如图3A中所示,前小叶和后小叶的自由边正常情况下沿着接合线C接触,但是如图3B中所示,在患有心肌病的患者体内可能留有显著的间隙G。
二尖瓣反流还可能在患有缺血性心脏病的患者身上发生,其中如图4中所示,乳头肌PM的功能受损。当左心室LV在心缩期收缩时,乳头肌PM不能充分收缩来实现正确的闭合。从而如图所示,小叶LF1和LF2脱垂。如箭头所示,再次发生从左心室LV向左心房LA的泄漏。
图5A更清楚地图示了二尖瓣MV的解剖结构,其为具有前侧ANT和后侧POST的二叶瓣。该瓣膜包括前(主动脉)小叶AL和后(壁)小叶PL。腱索CT将瓣膜小叶AL、PL与前外侧乳头肌ALPM和后内侧乳头肌PMPM相耦合。瓣膜小叶AL、PL沿着被称为前外侧连合部ALC和后内侧连合部PMC的线彼此接合。环AN包围瓣膜小叶,并且毗邻所述环的前部、位于前小叶的相对两侧上的两个区域被称为左纤维三角区LFT和右纤维三角区RFT。这些区域大体上以实线三角形标示。图5B更清楚地图示了左纤维三角区LFT和右纤维三角区RFT。
尽管已经提出了各种外科技术以及植入式装置,并且它们看起来是针对二尖瓣反流的有前途的疗法,但外科方法可能需要漫长的恢复期,而植入式装置具有不尽相同的临床结果。因此,仍然需要用于治疗二尖瓣反流的改进的装置、递送系统、装载夹具和方法。尽管本文公开的实施方式针对用于治疗二尖瓣反流的植入式假体二尖瓣,但是本领域技术人员将领会这并不旨在仅限于此,并且本文所公开的装置和方法还可用于治疗其他心脏瓣膜,诸如三尖瓣、主动脉瓣、肺动脉瓣等,以及治疗体内的其他瓣膜,诸如静脉瓣膜。
假体瓣膜。已通过外科手术将假体瓣膜植入在心脏之中作为对二尖瓣反流的治疗。这些瓣膜中的一些瓣膜是诸如猪瓣膜等取自动物的瓣膜,而其他瓣膜则是具有或不具有组织覆盖物的假体机械瓣膜。近来,微创导管技术已被用于向心脏递送假体瓣膜。这些瓣膜通常包括用于将瓣膜紧固至患者心脏的锚固件,以及瓣膜机构——机械瓣膜或是带有动物组织的瓣膜,或者它们的组合。假体瓣膜一旦被植入,就会接替功能失常的天然瓣膜,从而减小或消除瓣膜功能不全。尽管这些瓣膜中的一些瓣膜看起来是有效的,但仍然需要改进的瓣膜。在天然解剖结构中定位和锚固假体瓣膜仍是一个挑战。以下公开了克服与现有假体瓣膜相关联的一些挑战的假体瓣膜、用于该假体瓣膜的递送系统以及递送该瓣膜的方法的示例性实施方式。
图6图示了处于收缩配置(configuration)下的假体心脏瓣膜的示例性实施方式。已经从框架移除覆盖物(例如,织物或组织),以允许观察下面的框架600。该框架已被铺开和展平。假体瓣膜框架600具有心房区606、环形区608和心室区610。框架600由多个互连的支柱所形成,所述支柱形成一系列凸峰和凹谷,所述凸峰和凹谷可相对于彼此扩张和收缩从而允许将框架以收缩配置装载到递送导管上,并继而使其在靶治疗部位处径向扩张以供植入。优选实施方式为自扩张式,并且可使用超弹性镍钛诺(superelastic nitinol)或其他自扩张材料制成。还可以使用在高于转变温度时弹开的形状记忆合金,并且还可以使用可扩张构件以在需要塑性变形(例如,球囊扩张)来敞开框架时扩张该框架。
心房区606具有裙部616,该裙部616包括形成一系列凸峰和凹谷的多个互连的支柱。在该区域中,所述支柱相对于彼此偏斜,并且因此,所产生的单元图案具有一个扩大的末端,而相对的末端渐缩成较小的末端。在优选实施方式中,心房裙部的前部不像后部那样具有带凸缘的区域,因此心房区的前部602可具有比后区604更短的支柱。因此,所述前部中的凸峰和凹谷从心房区的其余后部中的凸峰和凹谷轴向偏移。由于这防止了心房裙部的前部中的支柱向上突出而潜在地碰撞左心房并导致穿孔,因此可能是有利的。此外,缩短的支柱和偏移的凸峰与凹谷形成对准元件614,该对准元件614可协助医师对假体瓣膜向二尖瓣的递送以及在假体瓣膜的扩张之前的假体瓣膜的对准加以可视化。可选的不透射线标记614a安置在偏移的凸峰和凹谷的任一侧上,并且进一步帮助在瓣膜植入期间的可视化。心房区优选地自扩张成圆柱形,或者其可具有D形横截面,其中前部602基本上是平坦的,而后部604为圆柱形。这允许心房裙部吻合天然二尖瓣的解剖结构,从而防止左心室流出道的阻塞。此外,心房裙部还可形成为使得在扩张时该裙部向外张开并形成可抵靠二尖瓣的上表面的凸缘。带凸缘的区域优选地沿着心房裙部的后部,并且心房裙部的前部保持无凸缘。或者,所述凸缘可在整个心房裙部周围延伸。心房区用连接支柱连接至相邻的环形区608,所述连接支柱优选地是直线的,并且基本上平行于框架的纵轴线。
环形区608也包含多个轴向定向并互连的支柱,所述支柱形成允许径向扩张的凸峰和凹谷。所述支柱优选地彼此平行,并且平行于框架的纵轴线。环形区也可为自扩张式,并且扩张成圆柱形,或者更优选地,环形区可扩张以具有如上文关于心房区所述的D形横截面。因此,环形区可类似地具有平坦的前部和圆柱形的后部。当递送时,环形区与二尖瓣环对准并且扩张成与二尖瓣环相接合。连接器支柱将环形区与心室区610接合起来。
心室区610也包括形成凸峰和凹谷的多个互连支柱。此外,心室区中的支柱形成小叶连合部613,所述小叶连合部613覆盖有织物、心包组织或其他材料,以形成假体瓣膜小叶。连合部中的孔允许向其附接缝合线。心室区中的支柱还形成向外扩张以接合前二尖瓣小叶和后二尖瓣小叶的心室裙部628,并且心室区中的支柱还形成前耳片624和后耳片630。前耳片被设计用于将前二尖瓣小叶捕获在前耳片的内表面与心室裙部的外表面之间。还可将任何相邻的腱索捕获在其间。另外,前耳片的尖端接合位于二尖瓣的前部上的纤维三角区,所述纤维三角区一个位于左侧,一个位于右侧。后耳片类似地将后二尖瓣小叶连同任何相邻的腱索一起捕获在后耳片的内表面与心室裙部的外表面之间。这将在下文中更详细地描述。
通过沿着框架控制前耳片或后耳片的支柱长度或轴向位置,可以控制耳片的展开。因此,在本示例性实施方式中,由于前耳片624和后耳片630中的支柱的长度及其沿着框架的相对位置彼此相同,因此当约束鞘套从耳片缩回时,前耳片和后耳片将会部分地一起向外弹出。随着该约束鞘套被进一步缩回,前耳片的其余部分将会径向向外自扩张。约束鞘套的进一步回缩继而允许后耳片的其余部分完成其径向扩张,并且最终心室裙部将会径向向外扩张。虽然后耳片和心室裙部的支柱长度和轴向位置相似,但内部支柱将心室裙部与连合部相连接,而这稍微延迟了心室裙部的扩张,因而后耳片在心室裙部之前完成扩张。使用这样的假体瓣膜展开顺序可以允许更准确地递送瓣膜,并且还允许更牢固地将瓣膜锚固到位。
缝合孔621沿着环形区和心室区的支柱安置,以允许诸如心包或聚合物(诸如涤纶或ePTFE)等覆盖物的附接。缝合孔还可沿着框架的任何其他部分安置。倒刺623沿着心室裙部628安置,以帮助将假体瓣膜锚固到相邻的组织。连合耳片或耳片612安置在连合部613的尖端上,并且可如下文所述那样用于将连合部可释放地与递送系统相耦合。这允许框架首先扩张,并且继而可于随后从递送系统释放连合部。本领域技术人员将会理解,可以使用多种支柱几何结构,并且此外可以调整诸如长度、宽度、厚度等支柱尺寸,以便为锚固件提供期望的机械性能,诸如刚度、径向抗压强度、连合部挠曲等。因此,图示的几何结构并不旨在成为限制性的。
框架可通过EDM、激光切割、光化学蚀刻或本领域中已知的其他技术来形成。可以使用皮下注射管或平板来形成框架。一旦已切割出框架并将其形成为圆柱体,则可将其径向扩张成期望的几何形状并使用已知的工艺对其进行热处理以固化该形状。因此,可以将假体瓣膜以收缩配置装载到递送导管上,并使用约束鞘套来将其约束于收缩配置。约束鞘套的移除将会允许锚固件自扩张成其无偏斜的预设形状。在其他实施方式中,可以使用诸如球囊等可扩张构件来将锚固件径向扩张成其优选的扩张配置。
图7图示了收缩配置下的假体心脏瓣膜的另一示例性实施方式,并且该假体心脏瓣膜与先前实施方式相似,主要区别在于前耳片、后耳片和心室裙部中的支柱长度。通过改变支柱长度而允许对前耳片和后耳片以及心室裙部的扩张顺序加以控制。已经从框架移除覆盖物(例如,织物或组织),以允许观察下面的框架700。该框架已被铺开和展平。假体瓣膜框架700具有心房区706、环形区708和心室区710。框架700由多个互连的支柱所形成,所述支柱形成一系列凸峰和凹谷,所述凸峰和凹谷可相对于彼此扩张和收缩从而允许将框架以收缩配置装载到递送导管上,并继而使其在靶治疗部位处径向扩张以供植入。优选实施方式为自扩张式,并且可使用超弹性镍钛诺或其他自扩张材料制成。还可以使用在高于转变温度时弹开的形状记忆合金,并且还可以使用可扩张构件以在需要塑性变形(例如,球囊扩张)来敞开框架时扩张该框架。
心房区706具有裙部716,该裙部616包括形成一系列凸峰和凹谷的多个互连的支柱。在该区域中,所述支柱相对于彼此偏斜,并且因此,所产生的单元图案具有一个扩大的末端,而相对的末端渐缩成较小的末端。心房区的前部702具有比后区704更短的支柱。因此,所述前部中的凸峰和凹谷从心房区的其余后部中的凸峰和凹谷轴向偏移。这允许创造出对准元件714来帮助医师将假体瓣膜递送到二尖瓣并在假体瓣膜的扩张之前对准假体瓣膜。心房区706的其他方面与图6中的心房区606的各方面相似。可选的不透射线标记714a安置在偏移的凸峰和凹谷的任一侧上,并且帮助在瓣膜植入期间的可视化。心房区优选地自扩张成圆柱形,或者其可具有D形横截面,其中前部702基本上是平坦的,而后部704为圆柱形。这允许心房裙部吻合天然二尖瓣的解剖结构,从而防止左心室流出道的阻塞。此外,心房裙部还可形成为使得在扩张时该裙部向外张开并形成可抵靠二尖瓣的上表面的凸缘。带凸缘的区域优选地沿着心房裙部的后部,并且心房裙部的前部保持无凸缘。或者,所述凸缘可在整个心房裙部周围延伸。心房区用连接支柱连接至相邻的环形区708,所述连接支柱优选地是直线的,并且基本上平行于框架的纵轴线。
环形区708也包含多个轴向定向并互连的支柱,所述支柱形成允许径向扩张的凸峰和凹谷。所述支柱优选地彼此平行,并且平行于框架的纵轴线。环形区也可为自扩张式,并且扩张成圆柱形,或者更优选地,环形区可扩张以具有如上文关于心房区所述的D形横截面。因此,环形区可类似地具有平坦的前部和圆柱形的后部。当递送时,环形区与二尖瓣环对准并且扩张成与二尖瓣环相接合。连接器支柱将环形区与心室区710接合起来。
心室区710也包括形成凸峰和凹谷的多个互连支柱。此外,心室区中的支柱形成小叶连合部713,所述小叶连合部713覆盖有织物、心包组织或其他材料,以形成假体瓣膜小叶。连合部中的孔允许向其附接缝合线。心室区中的支柱还形成向外扩张以接合前二尖瓣小叶和后二尖瓣小叶的心室裙部728,并且心室区中的支柱还形成前耳片724和后耳片730。前耳片被设计用于将前二尖瓣小叶捕获在前耳片的内表面与心室裙部的外表面之间。还可将任何相邻的腱索捕获在其间。另外,前耳片的尖端接合位于二尖瓣的前部上的纤维三角区,所述纤维三角区一个位于左侧,一个位于右侧。后耳片类似地将后二尖瓣小叶连同任何相邻的腱索一起捕获在后耳片的内表面与心室裙部的外表面之间。这将在下文中更详细地描述。
通过沿着框架控制前耳片或后耳片的支柱长度或轴向位置,可以控制耳片的展开。因此,在本示例性实施方式中,由于前耳片724和后耳片730中的支柱的长度及其沿着框架的相对位置彼此相同,因此当约束鞘套从耳片缩回时,前耳片和后耳片将会部分地一起向外弹出。随着该约束鞘套被进一步缩回,前耳片的其余部分将会径向向外自扩张,这是因为它们相对于心室裙部和后耳片中的支柱是最短的。约束鞘套的进一步回缩继而允许心室裙部径向扩张,并且最终鞘套的进一步回缩允许后耳片的其余部分完成其径向扩张。使用这样的假体瓣膜展开顺序可以允许更准确地递送瓣膜,并且还允许更牢固地将瓣膜锚固到位。
缝合孔721沿着环形区和心室区的支柱安置,以允许诸如心包或聚合物(诸如涤纶或ePTFE)等覆盖物的附接。缝合孔还可沿着框架的任何其他部分安置。倒刺723沿着心室裙部728安置,以帮助将假体瓣膜锚固到相邻的组织。连合耳片或耳片712安置在连合部713的尖端上,并且可如下文所述那样用于将连合部可释放地与递送系统相耦合。这允许框架首先扩张,并且继而可于随后从递送系统释放连合部。本领域技术人员将会理解,可以使用多种支柱几何结构,并且此外可以调整诸如长度、宽度、厚度等支柱尺寸,以便为锚固件提供期望的机械性能,诸如刚度、径向抗压强度、连合部挠曲等。因此,图示的几何结构并不旨在成为限制性的。可以类似于上文关于图6所描述那样形成框架。
图8图示了收缩配置下的假体心脏瓣膜的另一示例性实施方式,并且该假体心脏瓣膜与先前实施方式相似,主要区别在于后耳片被设计用于扩张以形成细长的水平区段,所述细长水平区段允许后耳片与位于后小叶和心室壁之间的环下区域的接合和锚固。因此,与仅具有由支柱间的单一合页所形成的渐缩尖端的后耳片相比,所述细长水平区段接触环下区域的更大区域。这提供了假体瓣膜的增强的锚固。在该示例性实施方式中,前耳片将会首选完全自扩张,随后是后耳片,继而是心室裙部。然而,在一些情况下,诸如递送系统、解剖结构等外部因素可改变扩张的顺序,因此这样的顺序并不旨在成为限制性的。已经从框架移除覆盖物(例如,织物或组织),以允许观察下面的框架800。该框架已被铺开和展平。假体瓣膜框架800具有心房区806、环形区808和心室区810。框架800由多个互连的支柱所形成,所述支柱形成一系列凸峰和凹谷,所述凸峰和凹谷可相对于彼此扩张和收缩从而允许将框架以收缩配置装载到递送导管上,并继而使其在靶治疗部位处径向扩张以供植入。优选实施方式为自扩张式,并且可使用超弹性镍钛诺或其他自扩张材料制成。还可以使用在高于转变温度时弹开的形状记忆合金,并且还可以使用可扩张构件以在需要塑性变形(例如,球囊扩张)来敞开框架时扩张该框架。
心房区806具有裙部816,该裙部816包括形成一系列凸峰和凹谷的多个互连的支柱。在该区域中,所述支柱相对于彼此偏斜,并且因此,所产生的单元图案具有一个扩大的末端,而相对的末端渐缩成较小的末端。心房区的前部802具有比后区804更短的支柱。因此,所述前部中的凸峰和凹谷从心房区的其余后部中的凸峰和凹谷轴向偏移。这允许创造出对准元件814来帮助医师将假体瓣膜递送到二尖瓣并在假体瓣膜的扩张之前对准假体瓣膜。心房区806的其他方面与图6中的心房区606的各方面相似。可选的不透射线标记814a安置在偏移的凸峰和凹谷的任一侧上,并且帮助在瓣膜植入期间的可视化。心房区优选地自扩张成圆柱形,或者其可具有D形横截面,其中前部802基本上是平坦的,而后部804为圆柱形。这允许心房裙部吻合天然二尖瓣的解剖结构,从而防止左心室流出道的阻塞。此外,心房裙部还可形成为使得在扩张时该裙部向外张开并形成可抵靠二尖瓣的上表面的凸缘。带凸缘的区域优选地沿着心房裙部的后部,并且心房裙部的前部保持无凸缘。或者,所述凸缘可在整个心房裙部周围延伸。心房区用连接支柱连接至相邻的环形区808,所述连接支柱优选地是直线的,并且基本上平行于框架的纵轴线。
环形区808也包含多个轴向定向并互连的支柱,所述支柱形成允许径向扩张的凸峰和凹谷。所述支柱优选地彼此平行,并且平行于框架的纵轴线。环形区也可为自扩张式,并且扩张成圆柱形,或者更优选地,环形区可扩张以具有如上文关于心房区所述的D形横截面。因此,环形区可类似地具有平坦的前部和圆柱形的后部。当递送时,环形区与二尖瓣环对准并且扩张成与二尖瓣环相接合。连接器支柱将环形区与心室区810接合起来。
心室区810也包括形成凸峰和凹谷的多个互连支柱。此外,心室区中的支柱形成小叶连合部813,所述小叶连合部813覆盖有织物、心包组织或其他材料,以形成假体瓣膜小叶。连合部中的孔允许向其附接缝合线。心室区中的支柱还形成向外扩张以接合前二尖瓣小叶和后二尖瓣小叶的心室裙部828,并且心室区中的支柱还形成前耳片824和后耳片830。前耳片被设计用于将前二尖瓣小叶捕获在前耳片的内表面与心室裙部的外表面之间。还可将任何相邻的腱索捕获在其间。另外,前耳片的尖端接合位于二尖瓣的前部上的纤维三角区,所述纤维三角区一个位于左侧,一个位于右侧。后耳片类似地将后二尖瓣小叶连同任何相邻的腱索一起捕获在后耳片的内表面与心室裙部的外表面之间。这将在下文中更详细地描述。后耳片与上文所述图6-图7中的后耳片相似,不同之处在于在本实施方式中,后耳片包括四个互连支柱而不是两个互连支柱。因此,在本实施方式中,所述多个互连支柱沿着耳片形成三个铰接区836。当后耳片扩张时,所述铰接区也将会扩张,从而形成细长的水平区段,所述细长水平区段允许后耳片与位于后小叶和心室壁之间的环下区域的接合和锚固。这样可以比仅具有较小的占位面积或单一的渐缩尖端的后耳片更好地帮助定位和锚固假体瓣膜以供接合二尖瓣的后部。本实施方式中的后小叶可由本说明书中描述的任何其他后耳片所替代。
通过沿着框架控制前耳片或后耳片的支柱长度或轴向位置,可以控制耳片的展开。因此,在本示例性实施方式中,由于前耳片824和后耳片830中的支柱的长度及其沿着框架的相对位置彼此相同,因此当约束鞘套从耳片缩回时,前耳片和后耳片将会部分地一起向外弹出。随着该约束鞘套被进一步缩回,前耳片的其余部分将会径向向外自扩张,这是因为它们相对于心室裙部和后耳片中的支柱是最短的。约束鞘套的进一步回缩继而允许后耳片的其余部分完成自扩张,随后是心室裙部的自扩张。使用这样的假体瓣膜展开顺序可以允许更准确地递送瓣膜,并且还允许更牢固地将瓣膜锚固到位。
缝合孔821沿着环形区和心室区的支柱安置,以允许诸如心包或聚合物(诸如涤纶或ePTFE)等覆盖物的附接。缝合孔还可沿着框架的任何其他部分安置。倒刺823沿着心室裙部828安置,以帮助将假体瓣膜锚固到相邻的组织。连合耳片或耳片812安置在连合部813的尖端上,并且可如下文所述那样用于将连合部可释放地与递送系统相耦合。这允许框架首先扩张,并且继而可于随后从递送系统释放连合部。本领域技术人员将会理解,可以使用多种支柱几何结构,并且此外可以调整诸如长度、宽度、厚度等支柱尺寸,以便为锚固件提供期望的机械性能,诸如刚度、径向抗压强度、连合部挠曲等。因此,图示的几何结构并不旨在成为限制性的。可以类似于上文关于先前在上文描述的框架所述那样形成框架。
图9A图示了在已扩张之后的假体心脏瓣膜的框架900。由于每个上述框架都具有类似的几何结构,因此任何上述框架实施方式均可采取这种形式,但它们以不同的顺序扩张。框架包括具有前部914和后部916的心房裙部906。所述后部周围形成带凸缘的区域,而所述前部保持无凸缘。此外,前部大体上是平坦的,而后部为圆柱形,从而形成适应二尖瓣解剖结构的D形横截面。图9B为图9A中的实施方式的俯视图,并且更清楚地图示了所述D形横截面。
框架还包括环形区910和心室裙部912。前耳片904(在该视图中仅有一个可见)完全扩张,使得在前耳片的内表面与心室裙部的外表面之间存在空间。这允许将前小叶和相邻的腱索捕获于其间。类似地,后耳片902也完全展开,且在后耳片902的内表面与心室裙部的外表面之间具有类似的空间。这允许将后小叶和相邻的腱索捕获于其间。还可看到连合杆908,并且其安置在由框架所形成的内通道中。连合杆用于形成假体二尖瓣小叶。扩张的框架的整体形状为D形,其中前部是平坦的而后部为圆柱形。
图10图示了扩张的框架由附接至框架的诸如心包组织或者如ePTFE等聚合物或者如涤纶等织物之类的覆盖物1002所覆盖,从而形成假体心脏瓣膜1000。心房裙部可完全由材料所覆盖,或者在优选实施方式中,仅将覆盖物安置在心房裙部的带凸缘的部分中的相邻单元中的相邻支柱1012之间。位于相同单元内的相邻支柱之间的区域1014保持无覆盖。这允许在植入假体瓣膜的同时保持血液流动基本上不受妨碍。可以使用缝合线1010来将覆盖物附接至框架。在该视图中,只有假体瓣膜的后部上的后耳片1006连同心室裙部1008和心房裙部1004是可见的。
递送系统。图11A-图11D图示了可用于递送本说明书中所公开的任何假体心脏瓣膜的递送系统的示例性实施方式。虽然该递送系统设计用于优选地经心尖递送假体心脏瓣膜,但本领域技术人员将会理解,还可对其做出修改以便可以诸如使用经中隔路径,腔内地经由导管递送假体瓣膜。本领域技术人员将会理解,使用经中隔路径可能要求修改各个轴的相对运动以便适应递送系统相对于二尖瓣的位置。
图11A图示了递送系统1100的透视图。递送系统1100包括靠近递送系统的近端的手柄1112和远侧组织穿透尖端1110。递送系统中包括4个细长轴,这些细长轴包括:外鞘套导管轴1102;钟形导管轴1104,其可滑动地安置在外鞘套导管轴1102中;衬套导管轴1106,其相对于其他的轴保持静止,但所述钟形导管轴相对于该衬套轴滑动;以及内导丝导管轴1108,其也相对于其他的轴固定,并且具有管腔,该管腔的尺寸设定用于接纳从中穿过并穿出远侧组织穿透尖端的导丝。如下文将会更详细地解释,使用致动器机构1114来控制各轴的移动,并且使用具有鲁尔连接器(luer connector)的冲洗线1116、1118来冲洗相邻的轴之间的环形区域。冲洗线1118用于冲洗外鞘套导管轴1102与钟形导管轴1104之间的环形空间。冲洗线1116用于冲洗钟形导管1104与衬套导管1106之间的环形空间。内导丝导管轴1108相对于衬套导管1106静止,因此可以用O形环或其他材料来密封环形空间。鲁尔连接器1122允许对导丝管腔的冲洗,并且可以将诸如Tuohy-Borst之类的止血阀耦合至鲁尔连接器以允许在保持止血的同时推进导丝穿过导丝导管轴。螺杆1120保持手柄壳体耦合在一起。图11B图示了递送系统1100的侧视图。
图11C为递送系统1100的局部分解图,并且更清楚地图示了手柄1112中的组件以及它们如何相互作用。手柄1112包括具有两个半部1112a、1112b的壳体,所述两个半部1112a、1112b容纳所有的组件。手柄优选地由螺杆1120和螺母1120b保持在一起,但其还可使用诸如压配合、卡扣配合、粘接、超声焊接等其他技术来密封。致动器轮1114的旋转转化为螺纹嵌件1124的直线运动。外鞘套导管轴1102耦合至螺纹嵌件1124,因此致动器轮1114在一个方向上的旋转将会推进鞘套导管轴1102,而在相反方向上的旋转将会缩回鞘套导管轴1102。致动器轮1114的进一步旋转将螺纹嵌件1124缩回到足以碰到耦合至嵌件1128的销钉1126,从而还移动嵌件1128。钟形导管轴1106耦合至嵌件1128,因此致动器轮1114的进一步旋转将会移动外轴1102并且还移动钟形导管轴1106。致动器轮在相反方向上的旋转推进鞘套,并且螺纹嵌件1124从销钉1126脱离。弹簧1130使嵌件1128回到其无偏斜位置,从而使钟形导管轴回到其无偏斜位置。
本文所公开的任何假体心脏瓣膜均可由递送系统1100来携带。心房裙部、环形裙部、前耳片、后耳片和心室裙部被装载在钟形导管轴上,并且安置在外鞘套导管轴1102之下。心室裙部被装载在近端使得其最靠近手柄1112,并且心房裙部被装载在最远端因此其最靠近尖端1110。因此,外鞘套导管轴1102的回缩在控制假体心脏瓣膜的展开中发挥重要作用。心房裙部因此在外鞘套导管缩回时首先扩张。假体瓣膜连合部可与衬套导管1106的远侧部分上的衬套1106a相耦合,并且继而将钟形导管轴安置在其上,从而将连合部可释放地与递送导管相接合。一旦假体心脏瓣膜的其他部分已经扩张,即可释放连合部。
图11D突出图示了递送系统1100的远侧部分。外鞘套导管轴1102相对于可滑动地安置在外鞘套导管轴1102中的钟形导管轴1104推进和缩回。图中示出衬套导管轴1106可滑动地安置在钟形导管轴1104中并且钟形导管轴1104被缩回,以便暴露出具有容纳假体瓣膜连合部的槽1106b的衬套1106a。内导丝导管轴1108为最内层的轴,并且具有渐缩的锥形区段1130,该锥形区段1130为假体瓣膜提供平滑过渡并且防止假体心脏瓣膜框架的不期望的弯曲或屈曲。组织穿透尖端1110适于穿透组织,特别是在经心尖心脏手术中穿透组织。
装载夹具。假体瓣膜可由医师手动装载到递送系统上,但这可能具有挑战性,因为必须相对于递送系统将瓣膜适当地定向,并且继而必须将连合杆与递送系统上的槽或容器相接合,并使其被捕捉在所述槽或容器中。这可能要求多个操作者同时操纵假体和递送系统及其致动器机构。因此,提供夹具来促进假体瓣膜向递送系统上的装载将会是有利的。图14-图18B图示了装载夹具(本文亦称为装载装置)的示例性实施方式,其可用于将诸如假体瓣膜等假体与递送系统相耦合。假体可以是包括本公开内容中所述的假体瓣膜在内的任何假体。类似地,递送系统可以是包括本文所述递送系统在内的任何递送系统。
图14图示了具有主体1438的装载装置1401,该主体1438包括三个联锁级或壳体,包括第一壳体1405(本文亦称为A级或A壳体)、第二壳体1407(本文亦称为B级或B壳体)和第三壳体1409(本文亦称为C级或C壳体)。装载装置1401允许诸如假体瓣膜等假体插入到装载装置的一端中,并且随着假体从中穿过,其总直径被减小,并且当对装载装置进行制动时,假体的选定区域被进一步径向向内压缩。这允许在递送之前使假体与递送系统相接合。
内部通道1439以入口孔1402始于第一壳体1405,并在出口孔1403处终止于第三壳体1409。三个手动操作的弹簧加载式致动器1404位于第三壳体1409中,并且用于按下诸如假体心脏瓣膜等假体的某些部分,以便将瓣膜装载到递送系统上,其细节在下文中更详细地描述。
如图15中可见,A级1405包括适配环1406,该适配环1406提供多个悬臂式耳片1415,该悬臂式耳片1415用于凭借卡扣配合件1417而与后续级的锁定窗1416配合。每个适配环1406用螺纹紧固件1414紧固到相应的级。通过按下悬臂式耳片1415,从锁定窗1416释放卡扣配合件1417,并且可以分离相应的级(1405、1407或1409)以使得装置的每个级都能被单独操纵。
图16示出了图15中所示的装载系统1401的剖视图。为了开始对假体心脏瓣膜的压缩,A级1405首先具有内部渐缩节段1426,该内部渐缩节段1426经由圆角过渡区1439与恒定直径的平坦节段1428相耦合。穿过A级1405具有将假体心脏瓣膜直径从第一较大输入值减小至第二较小输出值的作用,并且还帮助将瓣膜的框架或支架部分成形为具有圆形横截面。B级1407首先具有内部渐缩节段1427,该内部渐缩节段1427经由圆角过渡区1440与恒定直径的平坦节段1429相耦合。穿过B级1407具有再次将假体心脏瓣膜直径从第一较大输入值(A级1405的输出直径)减小至第二较小的最终输出值的作用。
在图15中以剖视图显示了装载系统1401的内部机械组件。当将瓣膜从B级1407推动至C级1409时,其保持在B级1407中所设定的输出直径。为了挠曲心脏瓣膜的某些部分,诸如连合部、锚固件或其他必要的定位特征,必须按下弹簧加载式致动器1404,其动作向假体瓣膜的定位特征传递线性位移。弹簧加载式致动器1404能够以可变的不同周向配置来布置,例如三个这样的致动器1404可以是成120°等间距的,以便挠曲心脏瓣膜假体的三个单独的定位特征。由于可以修改该设计以包含对支架的特定部分进行操作的任何合理数目和位置的此类致动器,因此令这种设计并不限于三个此类致动器,或者限于任何特定的定位方案。通过行进经过C级1409中的恒定直径通道1430,可使假体心脏瓣膜与弹簧加载式致动器1404的尖端1420相接触。弹簧加载式致动器1404包括可被按下的按钮1419、其上容纳有弹簧1411的轴1418、抵接有弹簧1411以提供回弹力的凸肩1421、在其中有空间供弹簧1411压缩的圆柱形窝眼1441,以及允许轴1418在未压缩状态与压缩状态之间自由转换的支承面1442,以及从洞1412突出并与心脏瓣膜相接触以允许压缩的尖端1420。
如图16中所见,盖板1410通过螺纹紧固件1413紧固至C级1409。盖板1410与C级1409共同发挥作用以容纳弹簧1411和弹簧加载式致动器1404。
图17图示了将A级1405、B级1407和C级1409组合起来的方式,并且详述了如先前所讨论的相关附接机构的位置。
如图18A中所见,C级1409的端视图具有出口孔1403。还图示了未压缩的直径圆1422,其代表弹簧加载式致动器1404的尖端1420所正常位于的初始大直径。图18B中继而示出了当致动时,弹簧加载式致动器1404的尖端1420转化成并吻合于较小的、压缩的直径圆1423。这是借以实现选择性假体瓣膜挠曲以使假体瓣膜的部分与递送系统相配合的机构。
本领域技术人员将会理解,所述装载装置并不限于三个单独的壳体。所述装置的替代实施方式可以包括单一壳体,该单一壳体包含所述三个单独的壳体的一些或所有特征。单一壳体实施方式在图27-图33中图示,并在下文描述。下文更详细地描述单一壳体装载装置的示例性实施方式。其他替代实施方法可以包括A壳体或B壳体之一以及C壳体,且这种配置可以作为两个可耦合的壳体或单一的集成壳体。在其他实施方式中,可以用单一壳体中的单一渐缩通道来完成整个直径减小,并且选择性挠曲可以是在同一壳体中或在单独的壳体中。本领域技术人员将会理解,所述三个壳体及其对应特征的任何组合或排列均可在装载装置中使用,以将假体装载到递送系统上。
图19-图26B图示了使用上文所述的装载装置来将诸如本文所述的假体瓣膜装载到诸如本文所述的递送系统上的示例性方法。图19图示了A级1405与通用假体心脏瓣膜1424之间的初始相互作用。在该示例中,通用假体心脏瓣膜1424包括三个锚固耳片1425,所述锚固耳片1425是该瓣膜模型向递送系统的定位和附接所需的。这三个锚固耳片1425可相当于先前在上文中关于公开的假体二尖瓣所描述的连合杆或支柱。当手动推动通用假体心脏瓣膜1424经过A级1405时,瓣膜滑下内部渐缩节段1426,滑过圆角过渡区1439,并滑入到恒定直径的平坦节段1428。为了安全地减小至少部分地由诸如镍钛诺等合金制成的心脏瓣膜假体的直径,首先有必要在冷盐水中冷却该假体,以便使装置低于被称为奥氏体终止温度的温度,所述奥氏体终止温度对于每种合金是特定的,并且取决于制造工艺。这是镍钛诺的晶体结构变得以允许在因应变所造成的永久损伤的风险很小的情况下塑性变形的方式而排列的温度。当通用假体心脏瓣膜1424位于平坦节段1428中并被手动调节以获得圆形时,A级1405准备好附接至B级1407,并且下文将会详述该过程的这一步骤。
如图20中所示,通过按压A级1405上的以进入到位于B级1407上的相应的锁定窗1416之中的卡扣配合件1417终止的悬臂式耳片1415,将A级1405接扣到B级1407上。在将A级1405接扣到B级1407上之后,可以推进通用假体心脏瓣膜1424跨过接合处并进入到内部渐缩节段1427,经过圆角过渡区1440,并最终进入到恒定和最终直径的平坦节段1429中。如果在图21中观察,可以更容易理解该过程的这一步骤,因为当通用假体心脏瓣膜1424在B级1407中呈现其终止位置时,从B级1407拆卸A级1405成为必要。
如图22中所示,通过按压B级1407上的以进入到位于C级1409上的相应的锁定窗1416之中的卡扣配合件1417终止的悬臂式耳片1415,将B级1407接扣到C级1409上。在将B级1407接扣到C级1409上之后,可以推进通用假体心脏瓣膜1424跨过接合处并进入到恒定和最终直径的平坦节段1430中。平坦节段1430的直径被设计为最优地将瓣膜1424压缩至最小直径,该最小直径仍然允许相应的递送系统或其组件穿通,并且仍然允许接近向递送系统的瓣膜装载和锚固所需的相关支架特征。
在图23中可以看到通用假体心脏瓣膜1424在C级1409内的最终的压缩位置。在可以进行对锚固耳片1425的准确挠曲之前,可能首先有必要在恒定直径的平坦节段1430内旋转瓣膜1424,以便将所有的锚固耳片1425与相应的弹簧加载式致动器1404的尖端1420对准。图23中图示了这种做法。在进行锚固耳片1425的对准之后,弹簧加载式致动器1404的准确操作成为可能。
如图24中可见,可以将通用递送系统1432引入到C级1409的出口孔1403,并且可以使位于锚固衬套1433中的固定窝眼(本文亦称为容器或槽)1434与通用假体心脏瓣膜1424的锚固耳片1425对准。
图25图示了这样的机构:通过该机构将弹簧加载式致动器1404的尖端1420按压到通用假体心脏瓣膜1424的锚固耳片1425中,以便通过弯曲来使其挠曲,并迫使锚固耳片1425进入到位于通用递送系统1432的锚固衬套1433中的相应的固定窝眼1434之中。
图26A示出了C级1409的端视图,伴有在最终挠曲之前被压缩并就位的诸如先前上文所述的假体心脏瓣膜1444。假体心脏瓣膜1444的相关特征包括心室裙部1435、三角形耳片1436以及连合锚固件(亦称为连合杆或支柱)1437,其详情可在本说明书中其他部分找到。
图26B示出了C级1409的端视图,伴有在最终挠曲之后被压缩并就位的假体心脏瓣膜1444。请注意,诸如心室裙部1435和三角形耳片1436等相关特征未由弹簧加载式致动器1404的任何部分所移位,并且,仅有连合锚固件1437被移位到最终减小的直径并被对于相应递送系统上的相应特征来说是可用的,其详情在本说明书中其他部分公开。一旦连合锚固件1437已被径向向内挠曲并定位在递送导管上的对应容器中,即可将外轴或鞘套可滑动地安置于其上以便捕获连合锚固件。继而可将另一外轴或鞘套可滑动地安置于假体瓣膜的其余部分上,以在递送过程中捕获瓣膜并保持其处于恰当位置。下文描述假体瓣膜的释放。
图27-图29B图示了装载系统的另一示例性实施方式。虽然该实施方式类似于先前所述的实施方式,但是该实施方式具有在装载过程中为假体的内表面和外表面提供支撑的优点,并且致动器还同时被致动。
如图27中所见,图中详细图示了瓣膜装载系统的变体。内锥2701为所要装载的瓣膜或假体的内表面提供支撑。内锥2701的重要特征包括锥形斜面2702以及可扭转的锁定机构2703,诸如插销栓。锥形斜面2702帮助座接所要装载的瓣膜,而可扭转的锁定机构2703通过下文将会进一步详述的扭转运动来允许内锥2701牢固地固定到外锥2704。
外锥2704的周长上的三个锁定挂钩2705允许外锥2704的基部配合内锥2701的锁定机构2703。外锥2704的螺纹节段2706始于初始端2709并终止于最终端2710,并且以允许与具有匹配的内螺纹的位移螺母2708相配合的方式具有螺纹。当将位移螺母2708被从初始端2709向前拧向最终端2710时,位移螺母2708的前缘迫使翅片或其他指状构件2707由于包含翅片2707的棱条2713的斜面以及位移螺母2708在骑跨于翅片2707上时的滑移运动而被下推。多个翅片2707可以在最终端2710处围绕外锥2708而周向间隔开,以便对期望的机构起作用。该实施方式优选地具有大致间隔开120度的三个翅片。
如图28A和图28B中所见,所述装置的端视图提供了相关部件之间的内在机械关系的进一步细节。图28B中可以看到衬垫2714安放于未挠曲位置2711。当位移螺母2708骑跨在螺纹节段2706上时,衬垫2714的位置径向向内移动至挠曲位置2712,如图29A中所示。多个衬垫2714可以在最终端2710处围绕外锥2708而周向间隔开,以便与相等的多个翅片2707一起对期望的机构起作用。
图30-图33图示了装载夹具的另一示例性实施方式。图30是装载系统的透视图。指状体2707a比先前的实施方式更粗,并且还具有凸轮形轮廓而不是斜坡形轮廓。另外,位移螺母2708a比先前的实施方式更细。这些特征有助于操作者平滑地致动位移螺母并径向收缩假体的一部分以便装载到递送系统上。此外,该实施方式包括位于锥的入口侧的“D”形凸缘3001(该特征还在图33中可见),其可以用于瓣膜对准的目的。其他对准特征将会在图31-图32中图示。因此操作者将会知道“D”形凸缘的平坦部分也是“D”形假体的平坦部分。
图31是移除了位移螺母的装载锥的等距视图,图中示出可以用于任何装载夹具实施方式中的可选特征。出现于装载锥的渐缩部分上的垂直槽3102充当用于所要对准的假体瓣膜上的缝线(未图示)的标志物。这允许在装载过程中准确地定位瓣膜。出现于装载锥的渐缩过渡部分上的水平槽3103充当能够借以抵靠支架的心房裙部区域进行固定的标志物,以便在连合部捕捉之前准确地定位瓣膜。装载锥可以由诸如聚碳酸酯等光学透明聚合物所形成,该聚合物允许用户在整个装载过程中看见瓣膜特征/标志物。
图32是装载锥的等距视图。已将可选的尺寸标注3004印在与D形凸缘3001相邻的锥的渐缩节段上。标记允许用户容易地识别和选择合适的装载夹具。
图33是装载锥的端视图。在该视图中可以清楚地看到D形凸缘3001。当向装载锥中装载瓣膜时,操作者可以在插入之前将瓣膜的平坦侧与D形凸缘的平坦部分进行定向。
图30-图33的实施方式提供了用于收缩假体瓣膜的单一级,并且因此比多级装载夹具更容易。如先前在上文所讨论,在装载过程中可以在冷盐水中冷却假体瓣膜。由于该实施方式比其他实施方式更小并具有更少的部件,因此其更轻且更易于使用,并且还减少了制造成本。它可以用单手致动,而其他实施方式可能需要不止一只手。
递送方法。可以使用多种方法来将假体心脏瓣膜递送到心脏。递送假体二尖瓣的示例性方法可包括腔内递送路径,这还可以是一种穿过心脏的右侧与左侧之间的隔膜的经中隔技术,或者在更优选的实施方式中,可以使用诸如图12A-图12L中所图示的经心尖路径。可以使用先前在上文中所述的递送装置来递送本文所述的假体瓣膜的任何实施方式,或者还可使用其他递送装置和其他假体瓣膜,诸如在先前通过引用并入本文的美国专利申请No.13/096,572中所公开的递送装置和假体瓣膜。然而,在这个优选的示例性实施方式中,使用图6的假体心脏瓣膜,使得前耳片首先展开,随后展开后耳片,并继而展开心室裙部。
图12A图示了包括左心房LA和左心室LV在内的患者心脏左侧的基本解剖结构。肺静脉PV将血液从肺部返回到左心房,而血液继而从左心房跨二尖瓣MV被泵送到左心室中。二尖瓣包括位于瓣膜的前侧A上的前小叶AL和位于瓣膜的后侧P上的后小叶PL。所述小叶附接至腱索CT,所述腱索CT接着由乳头肌PM紧固到心脏壁。血液继而被泵出左心室而进入主动脉Ao,并有主动脉瓣AV阻止反流。
图12B图示了递送系统1202穿过心脏的顶点向左心房LA中的经心尖递送。递送系统1202可在导丝GW上推进到左心房中,并且组织穿透尖端1204通过扩张组织并形成用于让递送系统的其余部分穿过的较大的通道来帮助递送系统穿过心脏的顶点。递送导管携带假体心脏瓣膜1208。一旦已将递送系统的远侧部分推进到左心房中,即可向近侧(例如,朝向操作者)缩回外鞘套1206,从而从假体瓣膜1208的心房部分移除约束。这允许心房裙部1210径向向外自扩张。在图12C中,随着外鞘套被进一步缩回,心房裙部继续自扩张并向外探出,直到其如图12D中所示完全展开。心房裙部可具有圆柱形的形状,或者其可如上文所讨论那样为D形并具有平坦的前部和圆柱形的后部以便避免妨碍主动脉瓣和左心室流出道的其他方面。可以向上游或下游推进假体心脏瓣膜,以正确定位心房裙部。在优选实施方式中,心房裙部形成抵靠二尖瓣的上表面的凸缘,而这对假体瓣膜加以锚固并阻止其不期望地向下游移动到左心室中。
随着外鞘套1206继续向近侧缩回,接下来假体心脏瓣膜的环形区自扩张成与瓣膜环相接合。环形区也优选地具有D形几何形状,但其还可为圆柱形或者具有其他几何形状以匹配于天然解剖结构。在图12E中,鞘套1206的回缩最终允许前耳片1212和后耳片1214同时部分地向外自扩张而优选地不接合前小叶或后小叶或者腱索。在该实施方式中,外鞘套1206的进一步回缩继而允许全部两个前耳片1212(在该视图中仅有一个可见)完成它们的自扩张,以便如图12F中所示将前小叶捕获在每个前耳片的内表面与心室裙部1216的外表面之间。后耳片1214保持部分敞开,但尚未完成其扩张。此外,如将在下文中更详细地说明,前耳片的尖端还锚固到二尖瓣的左纤维三角区和右纤维三角区中。
在图12G中,外鞘套1206的进一步回缩继而从后耳片1214释放约束,从而允许其完成其自扩张,由此将后小叶PL捕获在后耳片1214的内表面与心室裙部1218的外表面之间。在图12H中,鞘套被进一步缩回,从而释放心室裙部1220并允许心室裙部1220径向向外扩张,进一步将前小叶和后小叶捕获在心室裙部的外表面与它们相应的前耳片或后耳片之间。心室裙部的扩张还向外推动前小叶和后小叶,从而确保天然小叶不妨碍假体瓣膜或假体瓣膜小叶的任何部分。现在,假体瓣膜在二尖瓣之上、沿着环部、向瓣膜小叶以及在二尖瓣之下被锚固到位,从而将其紧固就位。
现在,如图12I中所示,递送装置的进一步致动将外鞘套1206和钟形导管轴1222缩回,以便从衬套导管1224移除约束。这允许从衬套导管释放假体瓣膜连合部1226,因此连合部扩张成它们的偏斜配置。继而如图12J中所示,移除递送系统1202和导丝GW,将假体瓣膜1208留在其替代天然二尖瓣的位置上。
图12K和图12L突出图示了前耳片和后耳片与相应的前小叶和后小叶的接合。在图12K中,在前耳片1212已经完全扩张之后,它们将前小叶AL和相邻的腱索捕获在前耳片的内表面与心室裙部1220的外表面之间。此外,前耳片1212的尖端1228与二尖瓣的前侧的纤维三角区FT相接合。所述纤维三角区为瓣膜的纤维区,因此前耳片进一步将假体瓣膜锚固到天然二尖瓣解剖结构中。一个前耳片锚固到左纤维三角区中,而其他前耳片锚固到右纤维三角区中。所述三角区位于小叶的前侧的相对两侧上。图12L图示了后耳片1214与后小叶PL的接合,所述后小叶PL被捕获在后耳片的内表面与心室裙部1220的外表面之间。此外,相邻的腱索也被捕获在后耳片与心室裙部之间。
图13A-图13L图示了递送方法的另一示例性实施方式。该实施方式类似于先前所述的实施方式,主要区别在于假体心脏瓣膜自扩张成与二尖瓣相接合的顺序。本文所公开的任何递送装置或任何假体心脏瓣膜均可使用,然而在优选实施方式中,使用图7的实施方式。改变所述顺序可允许更好地定位植入物、更容易地捕获瓣膜小叶,以及更好地锚固植入物。该示例性方法还优选地使用经心尖路径,但还可使用经中隔路径。
图13A图示了包括左心房LA和左心室LV在内的患者心脏左侧的基本解剖结构。肺静脉PV将血液从肺部返回到左心房,而血液继而从左心房跨二尖瓣MV被泵送到左心室中。二尖瓣包括位于瓣膜的前侧A上的前小叶AL和位于瓣膜的后侧P上的后小叶PL。所述小叶附接至腱索CT,所述腱索CT接着由乳头肌PM紧固到心脏壁。血液继而被泵出左心室而进入主动脉AO,并有主动脉瓣AV阻止反流。
图13B图示了递送系统1302穿过心脏的顶点向左心房LA中的经心尖递送。递送系统1302可在导丝GW上推进到左心房中,并且组织穿透尖端1304通过扩张组织并形成用于让递送系统的其余部分穿过的较大的通道来帮助递送系统穿过心脏的顶点。递送导管携带假体心脏瓣膜1308。一旦已将递送系统的远侧部分推进到左心房中,即可向近侧(例如,朝向操作者)缩回外鞘套1306,从而从假体瓣膜1308的心房部分移除约束。这允许心房裙部1310径向向外自扩张。在图13C中,随着外鞘套被进一步缩回,心房裙部继续自扩张并向外探出,直到其如图13D中所示完全展开。心房裙部可具有圆柱形的形状,或者其可如上文所讨论那样为D形并具有平坦的前部和圆柱形的后部以便避免妨碍主动脉瓣和左心室流出道的其他方面。可以向上游或下游推进假体心脏瓣膜,以正确定位心房裙部。在优选实施方式中,心房裙部形成抵靠二尖瓣的上表面的凸缘,而这对假体瓣膜加以锚固并阻止其不期望地向下游移动到左心室中。
随着外鞘套1306继续向近侧缩回,接下来假体心脏瓣膜的环形区自扩张成与瓣膜环相接合。环形区也优选地具有D形几何形状,但其还可为圆柱形或者具有其他几何形状以匹配于天然解剖结构。在图13E中,鞘套1306的回缩最终允许前耳片1312和后耳片1314同时部分地向外自扩张而优选地不接合前小叶或后小叶或者腱索。在该实施方式中,外鞘套1306的进一步回缩继而允许全部两个前耳片1312(在该视图中仅有一个可见)完成它们的自扩张,以便如图13F中所示将前小叶捕获在每个前耳片的内表面与心室裙部1316的外表面之间。后耳片1214保持部分敞开,但尚未完成其扩张。此外,如将在下文中更详细地说明,前耳片的尖端还锚固到二尖瓣的左纤维三角区和右纤维三角区中。
在图13G中,外鞘套1306的进一步回缩继而从心室裙部1320释放约束,从而允许心室裙部径向扩张。这继而进一步将前小叶AL捕获在前耳片1312与心室裙部1316之间。心室裙部的扩张还向外推动前小叶和后小叶,从而确保天然小叶不妨碍假体瓣膜或假体瓣膜小叶的任何部分。如图13H中所示的鞘套1306的进一步回缩从后耳片1314释放约束,从而允许其完成其自扩张,由此将后小叶PL捕获在后耳片1314的内表面与心室裙部1318的外表面之间。现在,假体瓣膜在二尖瓣之上、沿着环部、向瓣膜小叶以及在二尖瓣之下被锚固到位,从而将其紧固就位。
现在,如图13I中所示,递送装置的进一步致动将外鞘套1306和钟形导管轴1322缩回,以便从衬套导管1324移除约束。这允许从衬套导管释放假体瓣膜连合部1326,因此连合部扩张成它们的偏斜配置。继而如图13J中所示,移除递送系统1302和导丝GW,将假体瓣膜1308留在其替代天然二尖瓣的位置上。
图13K和图13L突出图示了前耳片和后耳片与相应的前小叶和后小叶的接合。在图13K中,在前耳片1312已经完全扩张之后,它们将前小叶AL和相邻的腱索捕获在前耳片的内表面与心室裙部1320的外表面之间。此外,前耳片1312的尖端1328与二尖瓣的前侧的纤维三角区FT相接合。所述纤维三角区为瓣膜的纤维区,因此前耳片进一步将假体瓣膜锚固到天然二尖瓣解剖结构中。一个前耳片锚固到左纤维三角区中,而其他前耳片锚固到右纤维三角区中。所述三角区位于小叶的前侧的相对两侧上。图13L图示了后耳片1314与后小叶PL的接合,所述后小叶PL被捕获在后耳片的内表面与心室裙部1320的外表面之间。此外,相邻的腱索也被捕获在后耳片与心室裙部之间。
虽然本文已经示出和描述了本发明的优选实施方式,但对于本领域技术人员而言将会显而易见的是,此类实施方式只是以举例的方式提供的。本领域技术人员将会想到众多不偏离本发明的变化、改变和替换。应当理解,在实践本发明的过程中可以采用对本文所述发明的实施方式的各种替代方案。以下权利要求旨在限定本发明的范围,并因此涵盖这些权利要求范围内的方法和结构及其等效方案。
Claims (19)
1.一种用于向递送系统上装载假体的方法,所述方法包括:
提供假体瓣膜,该假体瓣膜具有多个与之耦合的连合杆,其中所述假体瓣膜包括无偏斜直径;
致动致动器使其与多个所述连合杆接合;
在位于所述假体瓣膜的一端上的选定的分立区域中减小所述假体瓣膜的所述无偏斜直径,选定的所述分立区域包括所述连合杆,其中在致动所述致动器时,所述连合杆被移位至减小的直径,并且在所述一端上所述假体瓣膜的心室裙部和三角形耳片保持不移位;以及
将减小直径的该假体瓣膜装载到递送装置上。
2.根据权利要求1所述的方法,其中减小所述假体瓣膜的所述无偏斜直径包括致动壳体上的一个或多个所述致动器,一个或多个所述致动器选择性地接合所述假体瓣膜的选定的所述分立区域。
3.根据权利要求2所述的方法,进一步包括使所述假体瓣膜穿过所述壳体中的中心通道的恒定直径部分。
4.根据权利要求2所述的方法,其中致动一个或多个所述致动器包括径向向内按下一个或多个销钉或指状体,以接合所述假体瓣膜的所述分立区域,所述分立区域径向向内移动成减小的外形。
5.根据权利要求4所述的方法,其中按下包括同时按下所述一个或多个销钉或指状体。
6.根据权利要求1所述的方法,进一步包括将所述假体瓣膜的直径从所述无偏斜直径减小至小于所述无偏斜直径的第一直径。
7.根据权利要求6所述的方法,其中将所述假体瓣膜的直径从所述无偏斜直径减小至所述第一直径包括使所述假体瓣膜穿过渐缩的中心通道。
8.根据权利要求7所述的方法,其中使所述假体瓣膜穿过所述渐缩的中心通道包括推动或拉动所述假体瓣膜从所述渐缩的中心通道中穿过。
9.根据权利要求7所述的方法,其中使所述假体瓣膜穿过所述渐缩的中心通道包括将所述假体瓣膜塑形成具有圆形横截面。
10.根据权利要求6所述的方法,进一步包括将所述假体瓣膜的直径从所述第一直径减小至小于所述第一直径的第二直径。
11.根据权利要求10所述的方法,其中将所述假体瓣膜的直径从所述第一直径减小至所述第二直径包括使所述假体瓣膜穿过第二渐缩的中心通道。
12.根据权利要求11所述的方法,其中使所述假体瓣膜穿过所述第二渐缩的中心通道包括推动或拉动所述假体瓣膜从所述第二渐缩的中心通道中穿过。
13.根据权利要求1所述的方法,其中所述递送装置包括可滑动地安置在其上的内轴和外轴,并且其中装载所述减小直径的假体瓣膜包括将所述假体瓣膜安置在所述内轴与所述外轴之间。
14.根据权利要求1所述的方法,其中装载所述减小直径的假体瓣膜包括可释放地将所述连合杆与所述递送装置相接合。
15.根据权利要求1所述的方法,其中所述假体瓣膜由镍钛合金制成,并且所述方法进一步包括将所述假体瓣膜冷却至低于或等于所述假体瓣膜的奥氏体终止温度的温度。
16.根据权利要求15所述的方法,其中冷却所述假体瓣膜包括在冷盐水中冷却所述假体瓣膜。
17.根据权利要求10所述的方法,其中所述假体瓣膜的直径在第一壳体中从所述无偏斜直径减小至所述第一直径,并且其中所述假体瓣膜的直径在第二壳体中从所述第一直径减小至所述第二直径,并且其中所述方法进一步包括将所述第一壳体与所述第二壳体相耦合。
18.根据权利要求17所述的方法,进一步包括在所述直径已经减少至所述第一直径之后,将所述第一壳体从所述第二壳体解耦。
19.根据权利要求1所述的方法,进一步包括用支撑元件来支撑所述假体瓣膜的内表面。
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2013
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EP2854719A1 (en) | 2015-04-08 |
CA3080648A1 (en) | 2013-12-05 |
CN104507424B (zh) | 2016-08-17 |
CN104507424A (zh) | 2015-04-08 |
US10016275B2 (en) | 2018-07-10 |
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