CN106420112A - 依次展开的经导管二尖瓣假体 - Google Patents
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- 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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- 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
- A61F2/2403—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 pivoting rigid closure members
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- 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
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- 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
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Abstract
一种依次展开的假体心脏瓣膜,其包括自扩张框架,该自扩张框架具有心房裙部、心室裙部、以及安置于其间的环形区。第一前耳片安置在框架的前部上。后耳片位于自扩张框架的后部上。所述框架可设计成使得任何部分能够以任何期望的顺序依次扩张。例如,第一前耳片的一部分和后耳片的一部分可首先部分地自扩张。接下来,第一前耳片可在后耳片完全自扩张之前完全自扩张。接下来后耳片可完全自扩张,继而心室裙部自扩张;或者接下来心室裙部可自扩张,继而后耳片完全扩张。
Description
本申请是申请号为201280067082.0(国际申请号为PCT/CA2012/001060)、申请日为2012年11月20日、发明名称为“依次展开的经导管二尖瓣假体”的发明专利申请的分案申请。
相关申请的交叉引用
本申请为提交于2011年11月23日的美国临时专利申请No.61/563,156(代理人案卷号42194-704.101)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。
本申请涉及提交于2011年4月28日的美国专利申请No.13/096,572(代理人案卷号42194-703.201),该申请的全部内容通过引用并入于此。
技术领域
本发明总体上涉及医疗装置和方法,且更具体地涉及治疗瓣膜功能不全,例如二尖瓣关闭不全,亦称为二尖瓣反流。
背景技术
瓣膜功能不全(亦称为反流)的一种可能的疗法是使用通过传统的外科植入法递送或者通过创伤较小的经皮导管或微创经心尖法(transapical method)递送的假体瓣膜。
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。
多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(即,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、修复或重塑自体二尖瓣器的心内直视外科技术,以及用以改变自体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自体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效疗法,但它们可能难以递送,制造昂贵,或者可能不适用于所有患者。因此,期望提供用于治疗瓣膜功能不全,比如治疗二尖瓣功能不全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。
举例而言,公开内容通过引用而合并入于此的PCT国际专利号PCT/US2008/054410(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自体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自体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。
现有技术中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,见Hermann等人的美国专利公开号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自体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种方法是外科双孔成形法(surgical bowtie method),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合在一起。该手术更完整地公开于科学和专利文献中,例如公开于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WO2011/137531。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更牢固地将瓣膜锚固到位的改进的装置和方法。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治疗二尖瓣反流的假体瓣膜。尽管本公开着眼于治疗二尖瓣反流的假体瓣膜的使用,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。示例性心脏瓣膜包括主动脉瓣、三尖瓣或肺动脉瓣。
在本发明的第一方面,一种向具有带有前小叶或后小叶的二尖瓣的患者心脏递送植入式假体瓣膜的方法包括:提供假体瓣膜,其中该假体瓣膜包括可扩张框架,该可扩张框架具有第一末端、与所述第一末端相对的第二末端、位于所述可扩张框架的前部上的第一前耳片、位于所述可扩张框架的后部上的后耳片以及与所述可扩张框架的所述第一末端相邻的心室裙部。该假体瓣膜具有用于接合心脏的扩张配置和收缩配置。将该假体瓣膜以收缩配置递送到患者心脏的二尖瓣附近,并且径向向外扩张第一前耳片使得第一前耳片的尖端部分接合位于二尖瓣的前小叶的第一侧上的第一纤维三角区。与前小叶相邻的前腱索被置于第一前耳片与心室裙部的外前表面之间。在径向扩张第一前耳片之后,径向向外扩张后耳片,使得二尖瓣的后小叶和相邻的后腱索被置于后耳片与心室裙部的外后表面之间。在径向扩张后耳片之后,径向向外扩张心室裙部,从而接合前小叶和后小叶。将前小叶和相邻的前腱索捕获在第一前耳片与心室裙部的外前表面之间。将后小叶和相邻的后腱索捕获在后耳片与心室裙部的后外表面之间。
在本发明的另一方面,一种向具有带有前小叶或后小叶的二尖瓣的患者心脏递送植入式假体瓣膜的方法包括:提供假体瓣膜,其中该假体瓣膜包括可扩张框架,该可扩张框架具有第一末端、与所述第一末端相对的第二末端、位于所述可扩张框架的前部上的第一前耳片、位于所述可扩张框架的后部上的后耳片以及与所述可扩张框架的所述第一末端相邻的心室裙部。该假体瓣膜具有用于接合心脏的扩张配置和收缩配置。将该假体瓣膜以收缩配置递送到患者心脏的二尖瓣附近。径向向外扩张第一前耳片使得第一前耳片的尖端部分接合位于二尖瓣的前小叶的第一侧上的第一纤维三角区。将前小叶和相邻的前腱索置于第一前耳片与心室裙部的外前表面之间。在径向扩张第一前耳片之后,径向向外扩张心室裙部从而接合前小叶,使得前小叶和相邻的前腱索被捕获在第一前耳片与心室裙部的外前表面之间。在径向扩张心室裙部之后,径向向外扩张后耳片,使得二尖瓣的后小叶和相邻的后腱索被置于和捕获在后耳片与心室裙部的外后表面之间。
该方法可进一步包括提供递送导管,其中假体瓣膜可释放地与之耦合。递送假体瓣膜可包括从心脏外的区域向心脏的左心室经心尖地(transapically)递送假体瓣膜,或者可以从心脏的右心房向左心房经中隔地(transseptally)递送假体瓣膜。递送假体瓣膜可包括跨二尖瓣定位假体瓣膜,使得可扩张框架的第一末端位于二尖瓣的一部分的下方,并且可扩张框架的第二末端位于二尖瓣的一部分的上方。
扩张第一前耳片可包括从该第一前耳片缩回约束鞘套,使得第一前耳片可以自由地径向向外自扩张。假体瓣膜可进一步包括位于可扩张框架的前部上的第二前耳片,并且所述方法可进一步包括径向向外扩张该第二前耳片,使得第二前耳片的尖端部分接合位于与前小叶的第一侧相对的前小叶的第二侧上的第二纤维三角区。可以将前小叶和相邻的前腱索安置在第二前耳片与心室裙部的外表面之间。第二前耳片可与第一前耳片的扩张同时地径向向外扩张。在将第一纤维三角区或第二纤维三角区与相应的第一前耳片或第二前耳片相接合之前,以及在将前小叶和相邻的腱索安置在第一前耳片或第二前耳片与心室裙部的外表面之间之前,所述方法可包括部分地径向向外扩张第一前耳片或第二前耳片,使得第一前耳片或第二前耳片横向于(transverse to)假体瓣膜的纵轴线。扩张第二前耳片可包括从该第二前耳片缩回约束鞘套,使得第二前耳片可以自由地径向向外自扩张。
在一些实施方式中,在将二尖瓣的后小叶和相邻的后腱索安置在后耳片与心室裙部的外后表面之间之前,所述方法可包括部分地径向向外扩张后耳片,使得后耳片横向于假体瓣膜的纵轴线。在将前小叶和相邻的前腱索安置在第一前耳片与心室裙部的外前表面之间之后,所述方法可包括部分地径向向外扩张后耳片,使得后耳片横向于假体瓣膜的纵轴线,并且其中部分地扩张后耳片而不将二尖瓣的后小叶和相邻的后腱索安置在后耳片与心室裙部的外后表面之间。
径向扩张心室裙部可包括从心室裙部缩回约束鞘套,使得心室裙部可以自由地径向向外自扩张。心室裙部可包括多个倒刺,并且扩张心室裙部可包括将所述多个倒刺锚固到心脏组织中。假体瓣膜可进一步包括多个连合部,并且扩张心室裙部可使前二尖瓣小叶和后二尖瓣小叶径向向外移位,从而防止连合部与前小叶和后小叶之间的干扰。扩张心室裙部可使前瓣膜小叶和后瓣膜小叶径向向外移位而不接触左心室的内壁,并且不阻塞左心室的流出道。扩张心室裙部可不对称地扩张心室裙部,使得心室裙部的前部基本上平坦,而心室裙部的后部为圆柱形。
所述方法可进一步包括减少或消除二尖瓣反流。在一些实施方式中,假体瓣膜可携带治疗剂,并且所述方法可进一步包括将所述治疗剂从假体瓣膜洗脱到相邻组织中。假体瓣膜还可包括对准元件。第二纤维三角区安置在与前小叶的第一侧相对的前小叶的第二侧上,并且所述方法可进一步包括将对准元件与主动脉根部对准,以及将所述对准元件安置在第一纤维三角区与第二纤维三角区之间。对准所述对准元件可包括旋转假体瓣膜。
假体瓣膜可进一步包括多个连合部,并在它们之上安置有覆盖物,由此形成多个假体瓣膜小叶,并且所述方法可进一步包括从递送导管释放所述多个假体瓣膜小叶。所述多个假体瓣膜小叶可形成具有敞开配置和闭合配置的三尖瓣。所述多个假体瓣膜小叶可在敞开配置下被安置成彼此远离从而允许顺行血液流动穿过,并且所述多个假体瓣膜小叶可在闭合配置下彼此接合从而基本上阻止逆行血液流动穿过。
假体瓣膜可进一步包括心房裙部,并且所述方法可进一步包括径向向外扩张所述心房裙部,以便使其位于二尖瓣的上表面之上,并且抵靠二尖瓣的上表面接合心房裙部。扩张心房裙部可包括从心房裙部缩回约束鞘套,使得心房裙部可以自由地径向向外自扩张。可以相对于二尖瓣向上游或下游移动假体瓣膜,以确保心房裙部接合二尖瓣的上表面。抵靠所述上表面地接合心房裙部可将心房裙部抵靠着二尖瓣的上表面地密封,以阻止或基本上阻止其间的血液流动。
假体瓣膜可进一步包括环形区,并且所述方法可进一步包括径向向外扩张所述环形区,以便吻合二尖瓣的环部,并将所述环形区与二尖瓣环相接合。扩张环形区可包括从环形区缩回约束鞘套,使得环形区可以自由地径向向外自扩张。扩张环形区可包括不对称地扩张环形区,使得环形区的前部基本上平坦,而环形区的后部为圆柱形。
在本发明的另一方面,一种依次展开的假体心脏瓣膜包括自扩张框架,该自扩张框架具有第一末端、与所述第一末端相对的第二末端、靠近所述第二末端的心房区以及靠近所述第一末端的心室区。所述自扩张框架具有扩张配置和收缩配置。所述扩张配置适于接合心脏组织,而所述收缩配置适于递送到患者的心脏。假体瓣膜还包括安置在心房区中的自扩张心房裙部、安置在心室区中的自扩张心室裙部以及安置在心房区与心室区之间的自扩张环形区。第一自扩张前耳片安置在自扩张框架的位于心室区内的前部上。自扩张后耳片安置在自扩张框架的位于心室区内的后部上。第一自扩张前耳片的一部分和自扩张后耳片的一部分在从其移除约束时部分地径向向外自扩张。当从其移除约束时,第一前耳片在后耳片完全径向向外自扩张之前完全径向向外自扩张。当从其移除约束时,后耳片在心室裙部自扩张之前完全径向向外自扩张,而心室裙部最后完全扩张。
在本发明的又一方面,一种依次展开的假体心脏瓣膜包括自扩张框架,该自扩张框架具有第一末端、与所述第一末端相对的第二末端、靠近所述第二末端的心房区以及靠近所述第一末端的心室区。所述自扩张框架具有扩张配置和收缩配置。所述扩张配置适于接合心脏组织,而所述收缩配置适于递送到患者的心脏。假体心脏瓣膜还包括安置在心房区中的自扩张心房裙部、安置在心室区中的自扩张心室裙部以及安置在心房区与心室区之间的自扩张环形区。第一自扩张前耳片安置在自扩张框架的位于心室区内的前部上。自扩张后耳片安置在自扩张框架的位于心室区内的后部上。第一自扩张前耳片的一部分和自扩张后耳片的一部分在从其移除约束时部分地径向向外自扩张。当从其移除约束时,第一前耳片在心室裙部径向向外自扩张之前径向向外自扩张。心室裙部在后耳片完成自扩张之前径向向外自扩张,而后耳片在心室裙部自扩张之后完成自扩张。
心房裙部的至少一部分可覆盖有组织或合成材料。心房裙部可具有收缩配置和扩张配置。所述收缩配置可适于递送到患者的心脏,而所述扩张配置可相对于收缩配置径向扩张,并且可适于放置在患者的自体二尖瓣的上表面之上,从而将心房裙部锚固到左心房的一部分上。心房裙部可包括一个或多个不透射线的标记,并且可包括多个轴向定向的支柱,所述多个轴向定向的支柱用连接器元件连接在一起,从而将互连的支柱形成为一系列凸峰和凹谷。在心房裙部的自扩张之后,心房裙部可形成与自扩张框架的第二末端相邻的带凸缘的区域。此外,在自扩张之后,心房裙部可具有非对称D形横截面,该非对称D形横截面具有基本上平坦的前部和圆柱形的后部。假体瓣膜可进一步包括耦合至心房裙部的前部的对准元件,并且该对准元件可与患者心脏的主动脉根部对准并且可安置在患者的二尖瓣的前小叶的两个纤维三角区之间。
环形区的至少一部分可覆盖有组织或合成材料。环形区可具有收缩配置和扩张配置。所述收缩配置可适于递送到患者的心脏,而所述扩张配置可相对于收缩配置径向扩张,并且可适于吻合并且接合患者的自体二尖瓣的环部。在自扩张之后,环形区可具有非对称D形横截面,该非对称D形横截面具有基本上平坦的前部和圆柱形的后部。环形区可包括用连接器元件连接在一起的多个轴向定向的支柱,并且所述多个互连的支柱可形成一系列凸峰和凹谷。所述多个轴向定向的支柱中的一个或多个支柱可包括延伸穿过其中的一个或多个缝合孔,并且所述缝合孔的尺寸可设定为收纳缝合线。
心室裙部的至少一部分可覆盖有组织或合成材料。在自扩张之后,心室裙部可包括非对称D形横截面,该非对称D形横截面具有基本上平坦的前部和圆柱形的后部。心室裙部可具有收缩配置和扩张配置。所述收缩配置可适于递送到患者的心脏,而所述扩张配置可相对于收缩配置径向扩张,并且可适于使自体二尖瓣小叶径向向外移位。
第一前耳片可具有尖端部分,该尖端部分适于接合位于患者的二尖瓣的前小叶的第一侧上的第一纤维三角区,并且第一前耳片还可适于将前小叶和相邻的腱索捕获在第一前耳片与心室裙部的外前表面之间。假体心脏瓣膜可进一步包括第二自扩张前耳片,该第二自扩张前耳片安置在自扩张框架的位于心室区内的前部上。所述第二前耳片可具有尖端部分,该尖端部分适于接合位于患者的二尖瓣的前小叶的与前小叶的第一侧相对的第二侧上的第二纤维三角区。第二前耳片可适于将前小叶和相邻的腱索捕获在第二前耳片与心室裙部的外表面之间。第一前耳片或第二前耳片可具有安置于其上的覆盖物,该覆盖物增大耳片与心脏组织之间的接触面积。所述覆盖物可包括安置在与第一耳片或第二耳片耦合的聚合物耳片上的织物。后耳片可适于锚固在患者的二尖瓣的后小叶上,使得后耳片座合在后小叶与患者心脏的心室壁之间。后耳片可包括多个支柱,并且相邻的支柱可耦合在一起以形成多个可扩张的铰接连结。当后耳片径向扩张时,所述多个支柱可彼此移开,从而敞开所述铰接连结以形成拉长的水平区段,所述拉长的水平区段允许后耳片与位于后小叶和心室壁之间的子环区域(sub-annular region)的接合和锚固。因此,与仅具有由支柱间的单一铰链所形成的渐缩尖端的后耳片相比,所述拉长的水平区段接触子环区域的更大区域。心室裙部可进一步包括与之耦合的多个倒刺。所述多个倒刺可适于将心室裙部锚固到心脏组织中。心室裙部还可包括用连接器元件连接在一起的多个支柱,并且所述多个互连的支柱可形成一系列凸峰和凹谷。一个或多个所述支柱可包括延伸穿过其中的一个或多个缝合孔,所述缝合孔的尺寸设定为收纳缝合线。
假体心脏瓣膜可进一步包括多个假体瓣膜小叶。所述小叶中的每个小叶可具有第一末端和自由端,并且所述第一末端可与自扩张框架相耦合,而所述自由端可与所述第一末端相对。假体瓣膜小叶可具有敞开配置,其中假体瓣膜小叶的自由端安置成彼此远离,以允许顺行血液流动穿过。假体瓣膜小叶可具有闭合配置,其中假体瓣膜小叶的自由端彼此接合并且基本上阻止逆行血液流动穿过。所述多个假体瓣膜小叶可形成三尖瓣。一个或多个假体瓣膜小叶的至少一部分可包含组织或合成材料。一个或多个所述假体瓣膜小叶可包括具有连合耳片的连合杆(commissure post),并且所述连合耳片可适于可释放地与递送装置相接合。假体心脏瓣膜可携带适于从其洗脱的治疗剂。
在本发明的另一方面中,一种用于将假体心脏瓣膜递送到具有带有前小叶和后小叶的二尖瓣的患者心脏的递送系统包括:假体心脏瓣膜;内导丝轴,其具有延伸穿过其中的管腔,其中所述管腔的尺寸设定为可滑动地收纳导丝;以及远侧组织穿透尖端,其耦合至所述内导丝轴的远侧部分。所述远侧尖端适于穿过和扩张心脏中的组织,并且,连续张开区将内导丝轴与远侧尖端耦合起来。所述连续张开区配置为支撑假体心脏瓣膜,从而减少或消除假体心脏瓣膜的不期望的弯曲。所述递送系统还包括同心地安置在内导丝轴上的衬套轴(hub shaft)。假体心脏瓣膜可释放地耦合至所述衬套轴的远侧部分。钟形轴可滑动地且同心地安置在衬套轴之上,并且外鞘套可滑动地且同心地安置在钟形轴之上。假体心脏瓣膜以径向收缩配置被容纳在外鞘套中。递送系统还具有靠近递送系统的近端的手柄。该手柄包含致动器机构,该致动器机构适于推进和缩回钟形轴和鞘套。外鞘套相对于钟形轴的近端回缩可从假体心脏瓣膜移除约束,从而允许假体心脏瓣膜自扩张成与患者的二尖瓣相接合。假体心脏瓣膜可包括多个连合杆,并且所述连合杆可以可释放地与衬套轴的远侧部分相耦合。钟形轴相对于衬套轴的近端回缩可允许连合杆从衬套轴解耦。致动器机构可包括转轮。
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。
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而并入本文,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的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,其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的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14A-图14D图示了耳片覆盖物的示例性实施方式。
具体实施方式
现将参考附图来描述所公开的装置、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。
心脏的解剖结构。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。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转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至图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,断裂的索RCT可能因经由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在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效疗法,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,即接替功能失常的自体瓣膜,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。在自体解剖结构中定位和锚固假体瓣膜仍是一个挑战。以下说明书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从而导致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可能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加以可视化以及在假体瓣膜的扩张之前对准假体瓣膜。可选的不透射线的标记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自体二尖瓣的解剖结构,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。前耳片被设计成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。
通过控制前耳片或后耳片沿着框架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,因此当从耳片缩回约束鞘套时,前耳片和后耳片将会一起部分地向外弹出。随着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。使用这样展开假体瓣膜的顺序,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。本领域中技术人员将会理解,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,以便为假体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。
框架可通过放电加工(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(如果需要),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该收缩配置。约束鞘套的移除将会允许假体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假体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)来打开框架时扩张该框架。
心房区706具有裙部716,该裙部716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从而导致单元图案具有一扩大的末端,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。这允许生成对准元件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。可选的不透射线的标记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自体二尖瓣的解剖结构,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在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也由多个轴向定向并互连的支柱构成,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。
通过控制前耳片或后耳片沿着框架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,因此当从耳片缩回约束鞘套时,前耳片和后耳片将会一起部分地向外弹出。随着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,以允许附接诸如心包或聚合物(诸如涤纶或ePTFE)等覆盖物。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。本领域中技术人员将会理解,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,以便为假体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拉长的水平区段,所述拉长的水平区段允许后耳片与位于后小叶和心室壁之间的子环区域(sub-annularregion)的接合和锚固。因此,与仅具有由支柱间的单一铰链所形成的渐缩尖端的后耳片相比,所述拉长的水平区段接触子环区域的更大区域。这提供了假体瓣膜的增强的锚固。在该示例性实施方式中,前耳片将会首先完全自扩张,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)来打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从而导致单元图案具有一扩大的末端,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的凸峰和凹谷轴向偏移。这允许生成对准元件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。可选的不透射线的标记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自体二尖瓣的解剖结构,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在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也由多个轴向定向并互连的支柱构成,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。前耳片被设计为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至图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,从而形成拉长的水平区段,所述拉长的水平区段允许后耳片与位于后小叶和心室壁之间的子环区域的接合和锚固。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。本实施方式中的后耳片可由本说明书中描述的任何其他后耳片所替代。
通过控制前耳片或后耳片沿着框架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,因此当从耳片缩回约束鞘套时,前耳片和后耳片将会一起部分地向外弹出。随着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沿着环形区以及心室区的支柱安置,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。本领域中技术人员将会理解,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,以便为假体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。可以类似于上文所描述那样形成框架。
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。该框架包括具有前部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,其由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区域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为优选地经心尖地递送假体心脏瓣膜,但本领域中技术人员将会理解,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。本领域中技术人员将会理解,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(hubcatheter shaft)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;以及最后是内导丝导管轴1108,其也相对于其他的轴固定,并且具有管腔,该管腔的尺寸设定为收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。螺丝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。手柄优选地由螺丝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。因此心房裙部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。
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,并且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越二尖瓣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穿过心脏的顶点经由左心室LV向左心房LA中的经心尖递送。递送系统1202延导丝GW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。通过旋转假体并查看先前所述的对准元件,可以定向和正确定位假体。另外,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,而这对所述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自体解剖结构。在图12E中,鞘套1206的回缩最终允许前耳片1212和后耳片1214两者部分地向外自扩张,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,从而确保自体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留在其替代自体二尖瓣的位置上。
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自体二尖瓣解剖结构中。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在内的患者心脏的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越二尖瓣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穿过心脏的顶点经由左心室LV向左心房LA中的经心尖递送。递送系统1302延导丝GW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。通过旋转假体并查看先前所述的对准元件,可以定向和正确定位假体。另外,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,而这对所述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自体解剖结构。在图13E中,鞘套1306的回缩最终允许前耳片1312和后耳片1314两者部分地向外自扩张,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,从而确保自体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留在其替代自体二尖瓣的位置上。
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自体二尖瓣解剖结构中。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。
耳片覆盖物。在上文所述的示例性实施方式中,耳片(前三角形耳片和后心室耳片)总体上是狭窄的,并且颇为尖锐。先前关于图8所述的实施方式包括位于后耳片上的水平支柱,所述水平支柱帮助在更大的面积上分布力,并从而减少对组织的创伤。图14A-图14D图示了优选地随前三角形耳片一起使用以帮助减少创伤的另一实施方式。如果需要,其还可随后耳片一起使用。
图14A图示了具有尖端1404的前三角形耳片1402。该尖端可以是狭窄而尖锐的,因而在展开到组织中时引起组织创伤。因此,在一些实施方式中,可能期望在所述尖端上放置覆盖物来帮助减少组织创伤。图14B图示了可附接至三角形耳片1402的聚合物耳片1406。在其他实施方式中,该耳片可由诸如织物、金属等其他材料或者本领域中已知的其他材料所形成。所述聚合物耳片可由对聚合物片的激光切割而成,并且包括长轴向部分1408和增大的头部区域1410。多个缝合孔1412可预先切割到聚合物耳片1406中,并且所述孔的尺寸设定为收纳缝合材料。聚合物耳片上的预切割孔可与三角形耳片上的预切割孔对准,并且继而可以使用缝合线、粘合剂或本领域中已知的其他耦合技术来将聚合物耳片紧固到三角形耳片。继而将具有由铰接区域1416所分隔的两个对称半部的织物覆盖物1414缠绕在聚合物耳片周围,并通过缝合线将其附接至聚合物耳片,从而形成三角形耳片周围的覆盖。所述织物可以是涤纶、ePTFE或者本领域中已知的任何其他生物相容性材料。因此,覆盖物增加了三角形耳片与组织之间的接触表面积,从而减小了潜在创伤和刺穿心脏壁的可能性。此外,所述材料可允许组织长入,而这进一步有助于锚固假体。还对材料和尺寸加以选择,以便在以收缩配置递送的过程中保持低装置型面。
虽然本文已经示出和描述了本发明的优选实施方式,但对于本领域中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。本领域中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 (4)
1.一种用于向患者的心脏递送假体心脏瓣膜的递送系统,所述心脏具有带有前小叶和后小叶的二尖瓣,所述递送系统包括:
假体心脏瓣膜;
内导丝轴,其具有延伸穿过其中的管腔,所述管腔的尺寸设定为可滑动地收纳导丝;
远侧组织穿透尖端,其耦合至所述内导丝轴的远侧部分,所述远侧尖端适于穿过和扩张心脏中的组织,其中连续张开区将所述内导丝轴与所述远侧尖端耦合起来,所述连续张开区配置用于支撑所述假体心脏瓣膜,从而减少或消除所述假体心脏瓣膜的不期望的弯曲;
衬套轴,其同心地安置在所述内导丝轴之上,其中所述假体心脏瓣膜可释放地耦合至所述衬套轴的远侧部分;
钟形轴,其可滑动地并同心地安置在所述衬套轴之上;
外鞘套,其可滑动地并同心地安置在所述钟形轴之上,其中所述假体心脏瓣膜以径向收缩配置被容纳在所述外鞘套中;以及
手柄,其靠近所述递送系统的近端,该手柄包括致动器机构,该致动器机构适于推进和缩回所述钟形轴和所述鞘套。
2.根据权利要求1所述的递送系统,其中所述外鞘套相对于所述钟形轴的近端回缩从所述假体心脏瓣膜移除约束,从而允许所述假体心脏瓣膜自扩张成与患者的二尖瓣相接合。
3.根据权利要求1所述的递送系统,其中所述假体心脏瓣膜包括多个连合杆,并且其中所述连合杆可释放地与所述衬套轴的远侧部分相耦合,并且其中所述钟形轴相对于所述衬套轴的近端回缩允许所述连合杆从所述衬套轴解耦。
4.根据权利要求1所述的递送系统,其中所述致动器机构包括转轮。
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AU2019208326B2 (en) | 2018-01-19 | 2022-05-19 | Edwards Lifesciences Corporation | Covered prosthetic heart valve |
DE102018102940B4 (de) | 2018-02-09 | 2019-10-31 | Francisco Javier Carrero Gomez | Vorrichtung zur Prüfung der Funktion einer Aortenklappe |
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2012
- 2012-11-16 US US13/679,920 patent/US9308087B2/en active Active
- 2012-11-20 CA CA3180262A patent/CA3180262A1/en active Pending
- 2012-11-20 WO PCT/CA2012/001060 patent/WO2013075215A1/en active Application Filing
- 2012-11-20 ES ES12851477.5T patent/ES2677472T3/es active Active
- 2012-11-20 EP EP18171652.3A patent/EP3400907B1/en active Active
- 2012-11-20 CN CN201280067082.0A patent/CN104302247B/zh active Active
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- 2016-02-17 US US15/046,371 patent/US9713529B2/en active Active
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- 2017-04-20 JP JP2017083678A patent/JP2017148551A/ja not_active Withdrawn
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- 2019-04-03 AU AU2019202290A patent/AU2019202290B2/en active Active
- 2019-12-09 US US16/707,481 patent/US11413139B2/en active Active
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Cited By (6)
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CN110536656A (zh) * | 2017-04-18 | 2019-12-03 | 爱德华兹生命科学公司 | 心脏瓣膜密封装置及其递送装置 |
CN110536656B (zh) * | 2017-04-18 | 2023-01-17 | 爱德华兹生命科学公司 | 心脏瓣膜密封装置及其递送装置 |
CN111263622A (zh) * | 2017-08-25 | 2020-06-09 | 内奥瓦斯克迪亚拉公司 | 顺序展开的经导管二尖瓣假体 |
US11793640B2 (en) | 2017-08-25 | 2023-10-24 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
CN111050699A (zh) * | 2017-09-07 | 2020-04-21 | 爱德华兹生命科学公司 | 用于在人工心脏瓣膜中预防血瘀的整体冲洗方案 |
CN109199640A (zh) * | 2018-10-24 | 2019-01-15 | 宁波健世生物科技有限公司 | 一种人工瓣膜假体 |
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