CN101980670A - 用于假体心脏瓣膜的递送系统及植入方法 - Google Patents
用于假体心脏瓣膜的递送系统及植入方法 Download PDFInfo
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- CN101980670A CN101980670A CN200980110514XA CN200980110514A CN101980670A CN 101980670 A CN101980670 A CN 101980670A CN 200980110514X A CN200980110514X A CN 200980110514XA CN 200980110514 A CN200980110514 A CN 200980110514A CN 101980670 A CN101980670 A CN 101980670A
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Abstract
一种用于递送展伸的假体心脏瓣膜到患者的内腔的递送系统,该递送系统包括具有近端和远端的管状体以及从管状体的远端延伸的多个丝线(62),其中每个丝线具有卷曲的远端用于与展伸的假体心脏瓣膜的展伸器接合。还提供一种利用该递送系统布置可植入展伸装置的方法,其包括步骤:提供包括至少一个展伸接合部件(70)的可植入展伸装置,接合多个丝线(62的至少一个的卷曲的远端与展伸接合部件的其中之一,定位可植入展伸装置在植入位置,以及相对于管状体轴向移动多个丝线的至少一个以从丝线的卷曲的远端所接合的展伸接合部件脱离该丝线的卷曲远端。
Description
相关申请的交叉引用
本申请要求于2008年1月24日提交的名称为“用于假体心脏瓣膜的递送系统及植入方法”美国临时申请No.61/062,207的优先权,该申请的内容在此被全文引用作为参考。
技术领域
本发明涉及假体心脏瓣膜。更特别地,本发明涉及用于经皮植入假体心脏瓣膜的装置、方法和递送系统。
背景技术
病变或者先天不足的心脏瓣膜可以通过利用各种不同类型的心脏瓣膜手术进行修补或替换。典型的心脏瓣膜手术包括在全身麻醉下进行的开心手术法,在该过程中心脏停止,而血流通过心-肺旁道设备进行控制。这种类型的瓣膜手术是高度侵入式的并将患者暴露到许多潜在的严重危险,例如感染、中风、肾衰竭以及例如与使用心-肺设备相关的副作用。
近来,在对心脏瓣膜的最小侵入和经皮替换方面已经有越来越多的兴趣。这样的手术技术包括在患者的皮肤上开一个非常小的口,瓣膜组件经过该口插入到身体内并经由类似于导管的递送装置递送到心脏。该技术对于更多侵入形式的手术例如上述的开心手术法通常是优选的。在肺瓣膜替换的情形,Tower等人提交的美国专利申请公开No.2003/0199971A1和2003/0199963A1描述了一种牛颈静脉的瓣膜部,其安装在可展开的展伸器内,用于替换肺瓣膜。替换的瓣膜安装在囊导管上并经由血管系统经皮递送到失效的肺瓣膜的位置并通过囊展开以逆着右心室外流路径压缩瓣膜小叶,从而锚定和密封替换瓣膜。如在Bonhoeffer等人在“Journal of theAmerican College of Cardiology 2002”的39:1664-1669上发表的“Percutaneous Insertion of the Pulmonary Valve”以及Bonhoeffer等人在“Circulation 2000”的102:813-816上发表的“Transcatheter Replacement of aBovine Valve in Pulmonary Position”的文章中所述的,替换肺瓣膜可以被植入以替代本身的肺瓣膜或者修复位于瓣膜导管中的肺瓣膜。
各种类型和构型的假体心脏瓣膜被用于经皮瓣膜手术中以替换病变的人本身的心脏瓣膜。任何特定的假体心脏瓣膜的实际形状和构型在一定程度上取决于待替换的瓣膜(也就是,二尖瓣膜、三尖瓣膜、大动脉瓣膜或者肺瓣膜)。通常,假体心脏瓣膜设计试图复制待替换的功能,从而将包括与生物假体或者机械心脏瓣膜假体一起使用的瓣膜小叶状结构。换句话说,替换瓣膜可以包括以某些方式安装在可展开的展伸器内的瓣膜静脉部以形成展伸的瓣膜。为了制备用于经皮植入的这样的瓣膜,展伸的瓣膜刚开始可以以展开或者未卷绕的情形提供,然后围绕导管的囊部分卷绕或者压缩直到它尽可能地接近导管的直径。
其它的经皮递送假体心脏瓣膜已经由例如Bonhoeffer,P.等人在“Circulation 2002”的102:813-816上发表的“Transcatheter Implantation of aBovine Valve in Pulmonary Position”以及Cribier,A.等人在“Circulation,2002”的106:3006-3008上发表的“Percutaneous TranscatheterImplantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis”提出,其具有大致类似的构型,这些文章中公开的内容在此被引用作为参考。这些技术至少部分依赖于展开的支撑结构和本来的组织之间的摩擦类型的接合以保持递送的假体的位置,尽管响应由展伸器和有时用于展开展伸器的囊提供的径向力,展伸器也可以至少部分植入在周围组织中。这样,借助于这些经导管的技术,对患者本身的组织的假体心脏瓣膜的传统的缝合不是必需的。类似地,在Bonhoeffer,P.等人在“J Am Coll Cardiol,2002”的39:1664-1669上发表的标题为“Percutaneous Insertion of the PulmonaryValve”的文章中,描述了生物瓣膜的经皮递送,该文章中公开的内容在此被引用作为参考。瓣膜被缝合到预先植入的瓣膜或者非瓣膜的导管或者预先植入的瓣膜内的可展开的展伸器。再一次地,第二瓣膜展伸器的径向展开被用于布置和保持替换瓣膜。
用于心脏瓣膜的经皮递送的一些递送系统已经发生与心脏瓣膜粘附或者不稳定地从用于布置到患者的期望位置的递送系统释放相关的问题。在这些情形中,递送系统可以进一步被操控,其会导致瓣膜变为从期望的植入位置移走或者导致对患者的其它损伤。在极少数情况下,心脏瓣膜不能从递送系统释放,其然后会要求紧急手术来进行干涉。这样的手术会将患者暴露到巨大的危险和损伤。
尽管在经皮瓣膜替换技术和装置中已经有所进步,但是,存在持续的期望以提供不同设计的心脏瓣膜,其可以以最小侵入和经皮的方式被植入。还存在持续的期望以能够在瓣膜一旦已经被布置或者部分布置就复位和/或缩回瓣膜以为了能够保证薄膜在患者体内的优化的布置。特别地,这将会是有利的,即,提供允许一旦瓣膜定位在患者体内就完全或部分的复位和/或缩回瓣膜的瓣膜和相应的递送系统。此外,这将是有利的,即,提供一种递送系统,其能够稳定地释放心脏瓣膜而不会对展伸瓣膜引起力的施加,该力会使得瓣膜从期望的位置移走。最后,与经导管的瓣膜展伸器以及设计来适应展伸器的复杂的解剖相关的复杂性和不断改变的几何机构使得对能够顺次地释放经导管瓣膜展伸器的特定区域或部分存在需求。这使得能够带来更准确地定位装置和/或布置用于锚定、密封或者停靠装置的特定特征的优点。此外,使得不同径向力和/或几何机构的各个区域的释放顺次的能力在提高经导管的瓣膜装置的可递送性方面是重要的。
发明内容
能够用于本发明的递送系统的替换心脏瓣膜每个包括展伸器,瓣膜结构可以附着到该展伸器。用于本发明的递送系统和方法的展伸器包括能够单独使用或者与其它展伸特征结合使用的各种结构和特征。特别地,这些展伸器提供许多不同的停靠和/或锚定结构,其有助于其经皮递送。这样,许多展伸结构是可压缩到相对小的直径,用于经皮递送到患者的心脏,然后要么经由外部压缩力的去除(例如,自我展开的展伸器),要么通过施加外部径向力(例如,囊式可展开的展伸器)而展开。在此描述的由递送系统递送的装置可以用于递送展伸器、瓣膜展伸器或者其它干涉装置例如ASD(心房间隔缺损)闭合装置、VSD(室中隔缺损)闭合装置或PFO(未闭卵圆孔)闭塞器。
本发明的用于插入替换心脏瓣膜的方法包括递送系统,该递送系统能够在它们的插入过程中将展伸结构保持在它们的压缩状态并允许或者使得它们一旦处于它们的期望位置就展开所述展伸结构。特别地,植入展伸器的方法可以包括使用递送系统或者瓣膜展伸器,其具有附着到展伸框架的特征的多个具有卷曲或猪尾式末端的丝线。卷曲的丝线末端可以被弄直或者解卷曲以释放它们所附着到的展伸器。卷曲的或者猪尾式丝线末端构型允许展伸器从递送系统积极的、稳定的释放,而没有用其它递送系统可能会发生的不完全释放和/或粘附所致的相关复杂性。此外,展伸器从具有卷曲丝线末端的递送系统的释放并不需要直接施加力到展伸的瓣膜,所述力能够使得瓣膜从期望的植入位置移走。
本发明的递送系统和方法可以包括允许展伸器回复用于在它们已经从展伸递送系统布置或者部分布置后它们的移除或者再定位的特征。所述方法包括利用前进或者回退方法植入展伸结构。进一步地,在本发明的许多递送方法中,展伸结构是能够在活体内旋转的以允许展伸结构定位在期望的方向。
本发明的递送系统和方法提供心脏瓣膜的部分的顺次释放。也就是,递送系统具有用于在第一步中从心脏瓣膜的一个或多个结构特征脱离的促动能力,然后在一个或多个顺次的步骤中从该心脏瓣膜的其它结构特征脱离。这样,心脏瓣膜的布置能够相对渐进地执行,其可以提供医生在心脏瓣膜从递送系统完全释放之前复位或重新定位心脏瓣膜的机会。
附图说明
将参照附图进一步解释本发明,其中在数个视图中,相同的结构用相同的附图标记表示,并且,其中:
图1是本发明的递送系统的一个实施例的透视图;
图2是图1所示的递送系统的近端的透视图;
图3是当丝线附着到展伸框架时具有带卷曲的末端的多个丝线的盒的透视图;
图4是附着到展伸器的一个末端处的冠的图3的盒的放大侧视图;
图5是接近于它们将附着到其上的递送系统的一部分的图4的盒和附着的展伸器的侧视图;
图6是本发明的具有附着的展伸器的递送系统的侧视图;
图7是附着到展伸器的递送系统的丝线的卷曲的或者猪尾式的末端的放大透视图;
图8-10是示出从本发明的递送系统展开的展伸器的各个阶段的侧视图;
图11是具有带卷曲的或者猪尾式的末端的不同长度的丝线的递送系统的一部分的侧视图;
图12是具有带卷曲的末端以形成不同数量的环的丝线的另一个递送系统的一部分的侧视图;
图13是本发明的另一递送系统的一部分的侧视图;
图14-16是从图13所示类型的递送系统的猪尾式末端展开的各个阶段的展伸冠的顺次的截面侧视图。
图17是本发明的递送系统的另一个实施例的示意性前视图;
图18是图17的递送一些它的一部分的放大的前视图,示出附着到展伸器的冠的多个卷曲的丝线;
图19是图18所示的递送系统的系统部分的放大前视图;
图20是图17的递送系统的示意性前视图,具有从递送系统的所有卷绕的丝线分离的展伸器;
图21是图20的递送系统的一部分的放大前视图;
图22是本发明的猪尾式递送系统的丝线之一的透视图;
图23是相对于递送系统的实施例定位的展伸冠的侧视图;
图24是相对于递送系统的另一个实施例定位的展伸冠的侧视图;以及
图25是展伸递送系统的顺次的丝线释放构型的透视图。
具体实施方式
如在此所涉及的,根据各种装置以及心脏瓣膜递送的方法所用的假体心脏瓣膜可以包括各种不同的构型,例如,具有组织小叶的假体心脏瓣膜或者具有聚合物、金属或者组织工程的小叶的合成物心脏瓣膜,并可以特别配置用于替代任何心脏瓣膜。也就是,尽管在此的许多描述涉及主动脉瓣的替换,但是,本发明的假体心脏瓣膜通常还可以用于替换天然二尖瓣、肺瓣或者三尖瓣,其用作静脉瓣,或者用以替换失效的生物假体,例如在主动脉瓣或二尖瓣区域中的。
用于在此所述的递送装置和方法的每一瓣膜可以包括附着在展伸器的内部区域内的小叶;但是,该小叶在许多示例性实施例中为了清楚的目的而没有示出。通常,用于在此描述的递送系统和方法的展伸器包括支撑结构,该支撑结构包括相对于彼此安置的许多支柱或者丝线部分以提供期望的压缩性和强度给心脏瓣膜。但是,其它的展伸结构也可以被配置用于本发明的递送系统和方法,包括具有箔或金属框架或者能够充填可加硬材料或剂的可膨胀的内腔的展伸器,例如在美国专利No.5,554,185(Block)中所提出的。尽管可以使用许多不同构型的展伸器,但是,从广义上讲,在此描述的展伸器为大致管状或者圆柱的支撑结构,尽管直径和形状可以随着展伸器的长度变化,并且小叶固定到支撑结构以提供瓣膜展伸器。小叶可以由许多材料形成,例如,本领域已知的自体的组织、xenograph材料或者合成材料。小叶可以设置为同质的生物瓣膜结构,例如,猪瓣膜、牛瓣膜或者马瓣膜。或者,小叶可以彼此独立地设置(例如、牛心包小叶或者马心包小叶),并随后组装为展伸器的支撑结构。在另一替代实施例中,展伸器和小叶可以同时制造,例如可以利用由例如德克萨斯州San Antonio的Advanced Bio Prosthetic Surfaces Ltd(ABPS)公司生产的高强度纳米制造的镍钛薄膜而实现。支撑结构一般配置为容纳三个小叶,但是,在此所述的假体心脏瓣膜可以结合大于或者小于三个小叶。
更广泛地说,具有一个或多个小叶的支撑结构的组合可以呈现不同于所示和所描述的各种其它构型,包括任何已知的假体心脏瓣膜设计。在本发明的某些实施例中,具有小叶的支撑结构可以是任何的可展开的假体心脏瓣膜构型,不管囊是可展开的、自我展开的还是展开的(例如,如在下面的文献中所述的,即,美国专利No.3,671,979、4,056,854、4,994,077、5,332,402、5,370,685、5,397,351、5,554,185、5,855,601和6,168,614;美国专利申请公开No.2004/0034411;Bonhoeffer P.等人在“Pediatric Cardiology,2002”的39:1664-1669上发表的“Percutaneous Insertion of the PulmonaryValve”;Anderson J.R.等人在“EUR Heart J,1992”的13:704-708上发表的“Transluminal Implantation of Artificial Heart Valves”;Anderson J.R.等人在“EUR Heart J,1990”的11:(Suppl)224a上发表的“Transluminal CatheterImplantation of New Expandable Artificial Cardiac Valve”;Hubert S.L.等人在“J Thorac Cardiovascular Surgery,1989”的94:419-29上发表的“Evaluation ofExplanted Polyurethane Trileaflet Cardiac Valve Prosthesis”;Block P.C.于1998年10月1日在“The American Journal of Cardiology”的卷62上发表的“Clinical and Hemodyamic Follow-Up After Percutaneous AorticValvuloplasty In the Elderly”;Boudjemline,Y.在“Circulation,2002”的105:775-558上发表的“Steps Toward Percutaneous Aortic Valve Replacement”;Bonhoeffer.P在“Circulation,2002”的102:813-816上发表的“TranscatheterImplantation of A Bovine Valve in Pulmonary Position,a Lamb Study”;Boudjemline,Y.在“EUR Heart J,2002”的23:1045-1049上发表的“Percutaneous Implantation of a Valve In the Descending Aorta In Lambs”;Kulkinski,D.在“ASAIO J,2004”的50:364-68上发表的“Future Horizons InSurgical Aortic Valve Replacement:Lessons Learned During the Early Stages ofDeveloping a Transluminal Implantation Technique”;上述文献的教导在此被引用作为参考)。
本发明的展伸器的任选的定向和定位可以通过展伸器的自我定向(例如通过展伸器和先前植入的展伸器或者瓣膜结构之间的干涉)或者通过展伸器的人工定向而对齐它的特征和解剖特征或者先前的生物假体特征,例如可以通过利用荧光检查可视化技术实现。例如,当对齐本发明的展伸器与天生解剖结构时,它们应当对齐以使得不阻挡心脏动脉,并且天生的二尖瓣或三尖瓣的瓣膜应当相对于前面的小叶和/或三角形体/接合处对齐。
展伸器的支撑结构可以是由成形记忆材料例如镍钛合金(例如镍钛诺)形成的丝线。借助于成形记忆材料,支撑结构能够从收缩状态自我展开到展开状态,例如通过施加热、能量等,或者通过去除外部力(例如,压缩力)。该支撑结构还可以重复地被压缩和再膨胀而不会破坏展伸器的结构。此外,这样的一个实施例的支撑结构可以由单一片的材料激光切割而成,或者可以由许多不同部件组装而成。对于这些类型的展伸结构,可以使用的递送系统的一个例子包括具有覆盖展伸器直到它展开的能缩进的鞘的导管,在所述点上鞘可以缩回以允许所述展伸器展开。
展伸器或者可以为一系列的丝线或者丝线段,其安置得以使得它们能够通过施加或者移除外部和/或内部力而从收缩状态变换为展开状态。这些包括支撑结构的各丝线可以由金属材料或者其它材料形成。进一步地,丝线安置为以使得展伸器可以折叠或者压缩到收缩状态,其中它的内径比当该结构处于展开状态时它的内径小很多。在它的收缩状态,具有附着的瓣膜的该支撑结构可以安置在递送装置例如囊导管上。支撑结构配置为以使得当期望时它能够变化到它的展开状态,例如通过囊导管的展开或者去除通过例如鞘提供的外部力。用于这样的展伸器的递送系统可以设置为具有转动度和轴向定向能力以为了正确地定位新的展伸器在它的期望位置。
现参照附图,其中在整个的数个附图中各部件标有相同的标号,并且对于刚开始的附图1-10,展伸递送系统的一个实施例被示出。该系统可以包括用于初始附着展伸器和/或展伸装置到展伸基部装置以及随后附着到递送系统的盒(cartridge),从而提供由操作者进行的展伸器到递送系统的快速简单的附着。在一个实施例中,附着机构是楔形榫头类型的连接,其包括在盒和递送系统上的配合特征,其允许展伸部被预装载到盒并容易地由医生附着到递送系统。其它的连接装置也是可以想到的,例如咬合配合连接、螺纹连接、夹子、销、磁体等。或者,猪尾式的递送系统可以包括更多的永久附着的部件,其不需要使用基于盒的系统的特征。
本发明的一个递送系统可以进一步包括一系列丝线用于连接展伸瓣膜到递送系统。在一个实施例中,每个丝线可以在它的远端形成为卷绕或者“猪尾”构型。当丝线末端是卷绕的时,每个丝线的卷绕的末端可以固定到展伸器的特征,例如展伸冠。然后,弄直丝线可以释放它所固定到的展伸特征,如下面进一步详细描述的。
具有卷绕的远端82和近端84的丝线20的一个示例性实施例示出在图22中。丝线可以在远端82和近端84之间弯曲大约90度,或者,它可以以不同于90度的角度弯曲,或者,它可以是没有弯曲或者卷曲的直的丝线部分。如所示的,丝线20的远端82成形为产生大约1-1/2个圈或环;但是,丝线20可以包括比示出的更多或更少的圈或环。丝线可以由各种材料制成,例如高拉伸强度的弹簧丝线材料或者例如镍钛。或者,丝线可以是具有一定延展性的以使得一旦任何展伸瓣膜特征已经从丝线释放它不是必须返回到原来的卷绕形状。
每个丝线的猪尾末端的尺寸和确切构型可以被选取或者设计为以使得缩回和布置展伸器所需的力是在期望范围内。丝线的猪尾部分应当足够强以防止在展伸器定位、再装鞘、再定位等过程中从递送系统意外地释放。此外,丝线的猪尾部分应当足够柔性以使得在植入装置布置的过程中它不需要过大的力来弄直它。在一个示例性实施例中,丝线20直径为大约0.010英寸,因而需要大约7磅的拉力来解绕丝线20的远端82。但是,不同材料和不同尺寸的丝线可以用于提供不同的递送系统属性的猪尾丝线。
每一丝线20的近端84固定到位于盒或递送系统的中心内腔上的中心或基部部分。丝线20可以通过利用机械方法和/或胶粘剂固定到中心或基部部分。在一个实施例中,在远端82的卷绕或者猪尾部分刚开始围绕展伸器的一个末端的丝线卷绕,然后完全或部分弄直以布置展伸瓣膜。丝线可以是由弹簧材料或者成形记忆材料制成,其可以经由热处理熟化或“设置”以使得卷绕的丝线末端可以被缩回、旋转、再布置、脱离等,而无需利用其它的工具或者管理移除的部分。特别地,在它们的远端具有猪尾部分的丝线相对于一个或多个导管缩回,所述丝线包围在所述导管中直到猪尾部分与导管之一的一个末端相邻。也就是,丝线相对于导管被拉动,导管相对于丝线被向前推动,或者丝线和导管二者相对于彼此移动。卷绕圈或环的直径可以与导管开口直径相比尺寸相对较大,所述圈被拉动到所述开口中以使得当它们向着导管拉动时所述圈将接触并干涉导管的末端。丝线然后被进一步向后拉入导管内,从而弄直猪尾部分直到它们从它们已经成环圈的展伸丝线释放。在一个实施例中,猪尾部分的较大区域或者体积与导管的内部区域之间的干涉迫使猪尾部分随着被拉动到导管中而解绕或者弄直。或者,环的卷绕直径与它们被拉入的导管的直径相比可以尺寸相对较小(例如,参见图13),以使得当所述环向着导管拉动时展伸冠将与导管的末端接触和干涉。这将禁止展伸器移动以使得在丝线上的额外的拉力将使得卷绕的丝线末端解绕。
特别地,图1示出用于猪尾类型的系统的一个示例性递送系统10,所述系统一般包括近端12和远端14。图2示出图1的递送系统10的近端12的放大视图,其包括第一旋钮30和第二旋钮32用于控制在大致远端14的展伸器的递送和布置,如在下面进一步详细描述的。用于经皮展伸器和瓣膜递送的递送系统可以包括相对长的递送系统,其可以通过患者的脉管系统进行操控直至到达期望的解剖位置。在任何情形下,递送系统可以包括允许它递送展伸器到患者身体中的期望位置的特征。
盒16在图3中示出为与它将附着到的展伸器18相邻。展伸器18在图4中示出为经由丝线20的卷绕或猪尾末端附着到盒16。也就是,盒16包括具有从一端延伸的一系列丝线20以及在相反端的楔形榫头附着部分22的支柱19。每一丝线20包括在其近端84连接到支柱19的大致直的部分,并且在其远端82进一步包括“猪尾”或卷曲的部分。每个丝线20是由成形记忆类型的材料(例如镍钛诺)制成以使得当处于它将附着到的展伸部的近端时它可以通过施加外部力而被弄直,而当弄直力移除时它可以大致返回到它的卷曲构型。或者,当足够的力已经施加到它上以从递送系统释放展伸的瓣膜时,永久变形的丝线可以被使用。
为了装载展伸器到盒16的丝线20上,每个丝线20的卷曲末端可以被弄直或者部分弄直并布置为与展伸器的冠或者“V”末端之一相邻。在每个丝线20上的力然后可以被被移除或减小以使得丝线圈的远端向着它的猪尾构型后退,从而缠绕和捕获展伸器18的一个冠,如图4所示。或者,延展性类型的丝线材料可以被使用,其中圈可以在展伸器的装载处理过程中通过将丝线围绕展伸冠缠绕而形成。如果不同的展伸构型被使用,卷绕的丝线可以接合那种类型的展伸器的一些其它特征。盒优选地设置有与设置在相应的展伸器上的冠的数量相同数量的具有猪尾或卷绕丝线末端的丝线,尽管盒可以设置有更多或更少的具有卷绕末端的丝线。还可以想到的是,展伸器的单一的冠可以具有附着到它上的多于一个的猪尾丝线。在盒16的丝线20附着到展伸器18之后,如图4所示,盒和展伸器组合然后能够附着到递送系统10。
本发明的具有递送系统的盒的使用可以提供优势给展伸器装载处理。例如,盒和展伸器可以提供给医生预附着到盒的展伸器以使得医生不需要在手术之前执行展伸器附着步骤。此外,盒的构型简化了瓣膜到递送系统的附着,改善了附着的可靠性和稳定性,并消除瓣膜将错误地向后附着到递送系统的可能性。
示例性展伸器18,其有一端示出在附图中,是由一系列可以通过施加和去除外部力而压缩和展开的丝线制成,并可以包括一系列直径为例如大致0.011-0.015英寸的镍钛诺丝线。也就是,展伸器18可被认为是自我展开的展伸器。但是,本发明的猪尾丝线部分附着到其上的展伸器可以具有许多不同的构型并可以由大量的各种不同材料制成。但是,为了与本发明的递送系统一起使用,展伸器优选地设计为具有卷绕丝线末端能够附着到其上的至少一个点或特征。也就是,尽管开口末端类型的展伸冠被示出,但是也可以使用其它展伸末端构型,例如孔眼、环或其它开口。
图5示出递送系统10的一端,其具有楔形榫头部分24,该部分能够配合或者附着到盒16的相应的楔形榫头附着部分22,这是通过定位该两个部件以使得它们变为彼此接合而实现的。该特定的楔形榫头配置是示例性的,并且应当理解,可以替代地使用在递送系统的两个部分上的协作元件的不同的机械配置,其中展伸结构附着到递送系统的其中一个部件上,该部件顺次机械地附着到递送系统的另一部件。可以进一步想到的是,具有猪尾末端的丝线不是基于盒的系统的一部分,而是丝线可以直接附着到并不包括盒的递送系统。
如图6和7所示,在盒16附着到递送系统10之后,盒16及其附着的展伸器18然后通过向着递送装置的近端移动或者拉动盒16而缩回到递送系统的中空的导管或者内腔26中。该移动继续直到展伸器18的冠与内腔26的末端相邻。注意到,内腔26可以是系统的外鞘,或者它可以是内腔以使得另一鞘或导管可以定位在它的外部。由于展伸器18的可压缩属性,盒16向着递送装置的近端的继续移动将向着递送系统的中心内腔28拉动丝线20,从而同样向着中心内腔28拉动展伸器18的丝线。盒16然后可以向着装置的近端继续移动直到展伸器18完全围绕在内腔26内部,如在图1中所示的。能够用于展伸器18缩回到内腔26中的一个示例性的方法是在第一方向(例如顺时针方向)转动旋钮32(见图2)直到旋钮完全向前。当在与第一方向相反的第二方向(例如逆时针方向)转动旋钮32时旋钮30然后可以被拉动,直到展伸器缩回到递送系统中。
图8-10示出经由递送系统的展伸器18的布置,这将在展伸器18一旦大致位于患者内腔(例如,心脏瓣膜区域)中的它的期望的解剖位置就开始。特别地,图8示出随着内腔26移动远离递送系统的远端29进而暴露展伸器18的自由端(也就是,展伸器18的没有附着到卷曲的丝线20的末端)时的递送系统的近端。这样,通过将展伸器18包围在内腔26内所提供的压缩力被移除,展伸器18可以向着它原来的展开情形展开。图9示出该过程的下一步骤,其中内腔26从系统的远端28甚至更进一步地移动,从而允许展伸器18的整个长度从内腔26的内部释放以便其展开。
为了从递送系统10释放或者布置展伸器18,丝线20然后经由递送系统的促动机构向后朝着装置的近端拉动直到卷绕或猪尾部分与内腔26的末端直接相邻,如图10所示的。接着,具有沿着它们所附着到的内腔26延伸的丝线20的盒16被朝着装置的近端进一步拉动,直到丝线20的卷绕末端接触和干涉内腔26的末端,从而迫使丝线20在它们的远端解绕或者弄直。一旦丝线20被充分地弄直或者解绕,丝线20变为从展伸器18脱离,从而导致展伸器18处于患者体内的它的释放位置。可以用于借助该递送系统相对于内腔26这样地最终布置展伸器18的一个示例性的步骤顺序是在第一方向(例如,顺时针方向)转动旋钮32(见图2),直到展伸器暴露或者布置超过内腔26。旋钮30然后可以被缩回,从而从递送系统完全释放展伸器18。
注意到,在上面的方法中,展伸器可以在丝线20从展伸器18脱离的时刻之前在该处理的任何点上向后缩回到内腔26内,例如用于再定位展伸器,如果确定展伸器不是相对于患者解剖结构理想地定位的话。在这种情形中,上面描述的步骤可以被重复直到展伸器的期望定位被实现。
在使用上面描述的楔形榫头连接的递送系统中,或者允许展伸器连接到盒的卷绕的丝线的另一构型中,盒可以替代地预附着到瓣膜展伸器,共同包裹在苯乙哌啶酮溶液内,并以该预组装的方式提供给医生。这样,医生能够在植入步骤时简单地移除组件并将其附着到递送系统,这可以减小瓣膜展伸器刚好在植入时刻之前需要被操控的时间量。
借助上面描述的这个系统,通过瓣膜的所有或者部分血流可以在展伸瓣膜布置到患者体内但尚未从它的递送系统释放时的期间有利地得以保持。该特征可以帮助防止在通过一些其它已知的递送系统植入瓣膜过程中当血流停止或阻塞时会发生的复杂性。这还消除或降低对额外的处理步骤例如快速同步、循环帮助和/或其它程序的需求。此外,医生因此可以评估小叶的打开和闭合,检查任何瓣膜周围渗漏(paravalvular leakage),评估冠流动,以及在展伸瓣膜的最终释放之前正确定位瓣膜在目标解剖结构内。
上面描述的系统和处理可以包括同时或者大致同时弄直丝线以使得他们在它们的远端全部解绕或弄直以在单一步骤中从展伸器脱离。但是,可以想到,丝线可以以顺次的方式弄直,其中单个丝线、丝线对或者丝线的其它组合以一些预定的顺序选择性地弄直以顺次布置展伸器的部分。这可以通过递送装置的结构和/或展伸器的结构和/或通过使用的递送系统的操作而得以实现。
可以用于递送系统的一个示例性促动机构可以接合所有的或某些丝线以允许顺次释放各展伸器冠。冠的该顺次释放的有利之处在于,它允许高水平地控制展伸瓣膜的近端的直径方向的偏转(例如展开)。再者,高径向力展伸器的释放相应地可以最小化对解剖结构的伤害和损失。控制对展伸器全部或部分的直径方向的展开可以最小化在装置布置过程中装置移位、组装伤害和/或栓塞事件的可能性。此外,冠的顺序或者顺次的释放对于任何一个丝线或一组丝线与同时释放全部丝线所要求的力的量相比可以要求更小的力。此外,展伸器的区域例如固定锚定部、瓣部等可以以期望的顺序释放以优化所述布置的定位和一致性。最后,展伸器在不同几何结构(内流翼、球形区域等)和/或不同径向力的不同的轴向带或区域处的特定区域的释放可以使得更准确和稳定地定位和释放装置。
图25示出展伸递送系统的顺次丝线释放构型的一部分的实施例,其包括大致沿着相同纵轴从圆盘200间隔开的第一圆盘200和第二圆盘202。圆盘200包括三个丝线206从其延伸的表面204。圆盘202包括三个丝线210从其延伸的表面208以及圆盘200的丝线206可以延伸通过其的三个孔212。每个圆盘的丝线和孔的数量可以根据期望多于或者少于三个。应当进一步理解,可以提供超过两个的圆盘,一个或多个丝线附着到每个圆盘。所有的丝线206、210终止在它们的远端,在该远端具有卷绕部分,所述部分可以包括在此讨论的任何卷绕丝线属性。在丝线206、210组中的每一丝线可以具有相同长度或者不同长度以使得卷绕末端距离圆盘202的表面208相同或不同的距离。该丝线释放构型进一步包括促动构件,其示意性地示出为丝线214、216,其中丝线214延伸通过圆盘200的中心孔218并附着到圆盘202,丝线216附着到圆盘200。丝线214、216可以独立促动以通过它们的附着的丝线210、206分别轴向移动圆盘200和202。促动丝线214、216意在为典型的促动装置,其中其它促动装置也可以使用以提供圆盘200、202的独立的轴向运动。
在另一个实施例中,多个丝线可以从展伸器以包括径向释放作为围绕展伸器周边的单个丝线、丝线对或者丝线组的展伸器丝线的顺序释放。例如,在圆周相对侧面上的展伸器丝线可以成对释放,然后该顺序可以以顺时针方向或者反时针方向继续直到所有的丝线从展伸器释放。这可以在相同的轴向平面中在丝线上执行。进一步有利的是,根据本发明,在各个轴向平面中从展伸器顺次释放丝线。这对于在平面中具有不同的径向力的展伸器是有价值的。在这样的情形中,递送系统可以例如包括卷曲的丝线末端。最后,本发明的递送系统还可以用于释放不同于展伸冠和环或者除了展伸冠和环之外的其它特定的展伸器特征和元件,例如展开的裙状件、停靠接口元件、密封特征、倒刺件、钩子等。
图11示出递送系统的末端部分的一个示例性实施例,其包括内腔40的另一实施例,多个丝线42的远端从该内腔延伸。如所示的,每一丝线42的远端具有相同数量的圈或环;但是,这些圈的每一个与内腔40的末端44之间的距离不同。这样,当丝线42附着到展伸器并向着内腔40的末端44拉动时,最短的丝线42将首先接触内腔40。足够的干涉优选地在丝线42和内腔40之间产生以使得当该最短丝线42被拉到内腔40中时,它被弄直并最终从它所附着到的展伸特征释放。丝线42将继续向着内腔40的末端44进一步移动直到下一最长丝线42接触内腔,所述丝线也将被解绕或者弄直以将其从展伸器释放。该过程将被重复直到所有丝线42从展伸器释放并且展伸器完全布置。尽管仅三个丝线42在该附图中示出,但是,可以替代地提供不同数量的丝线,并且优选地,提供的丝线的数量与由递送系统递送的展伸器上的冠的数量匹配。此外,所有的丝线可以在它们的远端具有不同长度和/或数量的弯曲部,或者至少一个丝线可以配置为与所述递送系统的至少一个其它丝线一致。例如,递送系统可以包括相同的一对丝线以使得在展伸器布置过程中每个丝线对从展伸器同时释放。
图12示出类似于图11的递送系统的末端部分的另一示例性实施例,它包括内腔50,多个丝线52的远端从该内腔延伸。再一次地,丝线52并不配置为彼此完全一致。如在该附图中所示的,每个丝线52的远端在它的卷绕末端具有不同数量的卷曲以使得当丝线52附着到展伸器并向着内腔50的末端54拉动时,所有或者大部分丝线52的卷曲部分将几乎同时接触末端54。丝线52到内腔50内的进一步的移动将使得卷曲末端同时开始弄直或解绕;但是,具有最少数量的卷绕的丝线52将完全或者几乎完全被首先弄直,从而从它们所附着的展伸特征释放这些丝线。丝线52的移动继续直到具有下一更大数量的卷绕的丝线从展伸器解绕和释放,并且所有的丝线52从展伸器释放以使得展伸器完全释放。与图11的实施例一样,该实施例提供顺次的而非同时的展伸特征(例如展伸冠)释放。注意到,可以在系统中使用大于或者小于三个的丝线52,并且所有的丝线52可以彼此不同,或者一些丝线52可以配置为一致的(例如,配置为同时释放的丝线对)。
本发明的递送系统的另一示例性实施例的远端示出在图13-16中。该递送系统提供用于附着展伸器或者展伸瓣膜的结构,其允许展伸器或者展伸瓣膜在其从递送系统释放之前完全直径方向地展开和评定。这样,在相邻解剖结构(例如,冠状动脉、束支、二尖瓣干涉等)上的血液动力学性能、稳定性和影响可以被评定,并且如果发现不足或者不准确,展伸器可以在展伸器从递送系统的最终释放之前被再次捕获和再定位。或者,如果在布置展伸器的处理过程中获得任何不期望的结果的话,整个展伸器可以在它从递送系统释放之前从患者移除。
更特别地参照图13,递送系统的末端部分被示出,其大致包括具有末端64的内腔60,多个丝线62的远端从所述末端64延伸。该内腔60可以是递送系统的外鞘。每个丝线62部分地围绕在导管66内,每个丝线62的卷绕末端延伸超过每一导管66的远端68。每个丝线62相对于各自的导管66是可纵向移动或滑动的。优选地导管66的尺寸以使得当丝线62向着内腔660拉动时,丝线62的卷绕末端将接触和干涉导管66的末端68。丝线62的继续移动然后将致使丝线62弄直直到它们从展伸器释放。这些步骤在附图14-16中通过单一导管66示出,附图14-16示出附着到(见图14和15)包括多个冠(未示出)的展伸器的冠70然后从其分离(见图16)的延伸的卷绕丝线62。在图14中,丝线62卷绕在展伸器的冠70周围,然后丝线62在方向72相对于导管66移动直到卷绕丝线部分接触导管66的末端74(见图15)。这将导致丝线62的卷绕部分和导管66的末端74之间的干涉。丝线62在方向72的继续移动将致使丝线66的卷绕末端展开。丝线62在方向72的移动将继续直到丝线62被充分弄直以从冠70释放,如图16所示。
导管66优选地相对不可压缩以使得当向着内腔被拉动时丝线62的卷绕部分中足够的张力使得丝线弄直。换句话说,导管在张力下的不可压缩性可以模拟柔性柱,其在当卷绕丝线末端抵靠着它们拉动时抵抗曲折。在图13的系统的替代实施例中,丝线62可以在它们的圈中具有不同长度和/或不同数量的卷绕(流入,如图11和12所示),以提供对丝线的顺次释放。在又另一替代实施例中,导管66可以具有不同的长度,从而提供导管66的末端和丝线62的卷绕部分之间的不同大小的间隙。
另一替代展伸器丝线释放实施例通过导管150的末端部分示出在图23中,丝线154的卷绕末端152定位在所述导管中。卷绕末端152附着到展伸冠156并且至少部分地被包围或容纳在导管150中。为了从展伸冠156分离丝线154,缩进力施加到丝线154直到展伸冠156接触导管150的末端158,这将限制展伸器的进一步移动。继续施加力到丝线154将致使卷绕末端152展开,从而从展伸冠156释放卷绕末端152。图24示出类似于图23所示的丝线释放实施例,但是额外的导管160’定位在导管150内。为了从展伸冠释放卷绕丝线末端,丝线可以通过导管160的末端162和卷绕丝线末端之间的干涉展开,和/或可以通过相对于导管150的移动而展开丝线,如关于图23所描述的那样。注意到,在本发明的这些以及其它实施例中丝线圈可以包括具有多个卷绕或者部分卷绕的完全或者部分的圈,这取决于期望的释放属性。
图17-21示出可以用于提供丝线的顺次释放的示例性的递送系统100,所述丝线的卷绕末端接合展伸器120,其中丝线全部具有大致相同的构型(也就是,长度、圈数等)。递送系统100包括具有末端104的内腔102,多个丝线106的远端从末端104延伸。每一丝线106被部分围绕在导管108内。每一丝线106的卷绕末端112延伸超过每一导管108的远端110。每个丝线106能够相对于其各自的导管108纵向移动或滑动。优选地,导管108的尺寸使得当丝线106向着内腔102拉动时(或当导管108相对于丝线106移动时),丝线106的卷绕末端112将接触导管108的远端110。丝线106相对于导管108的继续移动然后将使得丝线106的卷绕末端112弄直,从而有利于展伸器120从递送系统100释放。
递送系统100进一步包括把手130,内腔102从把手130延伸。把手130包括用于布置展伸器120的控制方面。特别地,把手130包括近端控制旋钮132、中间控制旋钮134和远端控制旋钮136。这些控制旋钮提供用于控制展伸器120的递送和布置。在本发明的一个示例性实施例中,这些旋钮是弹簧装载的以使得它们需要向着把手被按压以为了将它们沿着路径移动到新的位置。把手130还可以设置有一系列的制动器,所述制动器限定旋钮可以定位的特定位置。递送系统100还可包括能够用于控制各个丝线106或各组丝线的移动的其它旋钮、操控杆等。
为了在递送系统100上装载附着展伸器120的盒系统,控制按钮132、134、136移动到可以称作“装载位置”的位置。特定的制动器或其它的标识可以设置在递送系统上以表明旋钮的正确位置。然后盒可以利用楔形榫头连接或一些其它类型的固定附着机构附着到递送系统。近端旋钮132可以然后移动到“准备入鞘的位置”,而远端旋钮136移动到“入鞘位置”。这样,鞘将被移动到其中展伸器被鞘保护的位置。递送系统然后可以在它的期望位置插入到患者体内,这有利于展伸器的布置。移动近端旋钮132到“近端打开位置”以及移动远端旋钮136到“装载位置”然后可以布置展伸器120。为了排出展伸器120,在递送系统上的开关(未示出)或一些其它的控制机构可以移动到“打开位置”,远端旋钮136可以移动到“排出位置”,近端旋钮132可以移动到它的“排出位置”。中间旋钮134可以与其它旋钮同时操作以为了促进装载、入鞘、布置和排出程序。
递送系统100进一步包括双控制程序和机构以顺次将丝线106拉入到导管108内从而将它们从展伸器120的冠断开。在该实施例中,第一组丝线106可以首先从展伸器120移除,然后第二组丝线106可以从展伸器移除从而从递送系统100释放展伸器120。这样,单独的机构设置在把手130内以允许第一组丝线106通过操作控制旋钮之一而被拉入导管108内,然后允许第二组丝线106通过操控不同的控制旋钮而被拉入导管108内。每一组丝线106可包括丝线的一半,或者可以为每一组中的不同百分数的丝线106。将丝线分为组可以进一步包括使得每个其它的丝线包括在一个组中并且交替的丝线包括在第二组中,尽管丝线可以以不同的图案进行分组。可以进一步想到,可以提供其它的机构以使得丝线被分为多于两个组,它们通过单独的机构控制用于丝线的顺次释放。
图17和18示出其中每个丝线106在它们的远端112被附着到展伸器120的冠的步骤。图19示出其中一些丝线106已经被拉入到它们各自的导管108内从而弄直丝线的远端并将它们从展伸器120分离的步骤。但是,其余的丝线106保持附着到展伸器120的冠。图20和21示出当剩余的丝线106已经被拉入它们各自的导管108内从而弄直丝线的远端并将它们从展伸器120分离的步骤。这样,展伸器120从递送系统100的释放比所有丝线从展伸器同时释放更渐进。递送系统的部件替代地可以包括与示出的不同的部件以实现图18、19和21中更一般地示出的顺次丝线释放。
本发明的递送系统能够例如用于顶端和经股的程序,并可以具有能够根据需要转动展伸器的能力。递送系统可进一步包括可以容纳不同尺寸的展伸器的可移除的外鞘。
在本发明的许多描述的实施例中向着内腔拉动丝线的处理可以以许多方法实现,例如通过在粗牙螺纹上转动装置或者推动按钮以将其滑动以向着内腔拉动丝线。也就是,许多不同的机构可以用于实现丝线相对于递送系统的该移动。进一步,注意到,尽管在此描述的卷绕丝线末端大致示出为与展伸器的末端冠接合,但是卷绕丝线末端可以替代地接合中间展伸冠或者其它展伸特征。此外,尽管卷绕丝线末端在此被示出为与均一地设置在圆柱展伸器的末端上的展伸冠干涉,但是所述的卷绕丝线设计还可以适应具有展伸特征附着几何结构的非均一的轴向或纵向展伸冠的瓣膜展伸器的递送。
本发明的递送系统,其具有经由卷曲丝线末端附着的展伸器,可以递送通过患者的经皮开口(未示出)。植入位置可以通过插入导引丝线到患者体内而定位,所述导引丝线从递送系统的远端延伸。然后,递送系统远端沿着导引丝线推进直到展伸器相对于植入位置定位。在替代实施例中,展伸器经由最小侵入手术切口(也就是,非经皮的)递送到植入位置。在另一替代实施例中,展伸器经由开心/胸手术递送。在本发明的一个实施例中,展伸器可以包括辐射不透明的、产生回声的或者MRI可视的材料以有利于展伸器的正确布置的可视确定。或者,其它已知的手术可视辅助器可以结合到展伸器中。相对于展伸器在心脏内的布置描述的技术可以用于监测和修正展伸器在纵向方向相对于它所定位在其中的解剖结构的长度的布置。
在瓣膜上的一个或多个标记与相应的成像系统(例如,回波,MRI等)一起能够用于在此描述的各种可定位的递送系统以为了在将瓣膜从递送系统释放之前检验瓣膜的正确布置。许多因素可以被单独或组合考虑以检验瓣膜是否正确布置在植入位置,其中一些示例性因素如下:(1)在替换瓣膜周围没有瓣周漏,其在当血液流动通过瓣膜时可以有利地检查,因为这些递送系统允许流动通过和围绕瓣膜;(2)替换瓣膜相对于冠状动脉的优化的转动取向;(3)带有就位的替换瓣膜的冠状血流的存在;(4)替换瓣膜环带关于患者本身的解剖结构的正确的纵向对齐;(5)验证替换瓣膜的窦性区域的位置没有与本身的冠状血流干涉;(6)验证密封裙状物与解剖特征对齐以最小化瓣周漏;(7)验证替换瓣膜没有在最终释放之前引起节律不整;以及(8)验证替换瓣膜没有干涉相邻瓣膜例如二尖瓣膜的功能。
本发明现在已经参照其数个实施例进行了描述。在此引证的任何专利或专利申请的整个公开内容在此被引用作为参考。前面的详细描述和例子仅仅是为了理解的清晰而给出的。不应理解为不必要的限制。显然,对于本领域技术人员可以在所述的实施例中进行许多变化而不超出本发明的范围。这样,本发明的范围不应限制到在此描述的结构,而仅由权利要求的语言所描述的结构以及那些结构的等效物进行限制。
Claims (43)
1.一种在患者的解剖位置布置可植入展伸装置的方法,包括步骤:
提供在其远端包括第一和第二展伸接合结构的递送系统;
附着所述展伸装置的第一结构元件到所述第一展伸接合结构,并且附着所述展伸装置的第二结构元件到所述第二展伸接合结构;
将所述展伸装置推进到植入位置;以及
从所述递送系统的所述第一展伸接合结构顺次地脱离所述展伸装置的所述第一结构元件,然后从所述第二展伸接合结构脱离所述展伸装置的所述第二结构元件。
2.如权利要求1所述的方法,其中,所述第一和第二展伸接合结构每个包括具有远端的丝线,所述远端是卷绕的用于分别与所述展伸装置的所述第一和第二结构元件接合。
3.如权利要求1所述的方法,其中,所述展伸装置的所述第一和第二结构元件分别包括第一和第二展伸冠。
4.如权利要求2所述的方法,其中,第一丝线的卷绕远端包括第一数量的环圈,其中第二丝线的卷绕远端包括比所述第一丝线更大数量的环圈,并且其中顺次从所述第一和第二结构元件的各自的展伸接合结构脱离该第一和第二结构元件的步骤进一步包括促动一促动装置,该促动装置同时轴向移动所述第一和第二丝线。
5.如权利要求4所述的方法,其中,所述促动装置的促动致使所述第一丝线的所述卷绕远端解绕用于从所述第一结构元件脱离,然后致使所述第二丝线的所述卷绕远端解绕用于从所述第二结构元件脱离。
6.如权利要求2所述的方法,其中,第一丝线的卷绕远端包括第一数量的环圈,其中第二丝线的卷绕远端包括比所述第一丝线更大数量的环圈,并且其中顺次从所述第一和第二结构元件的各自的展伸接合结构脱离该第一和第二结构元件的步骤进一步包括在多个步骤中促动一促动装置以顺次轴向移动所述第一和第二丝线。
7.如权利要求2所述的方法,其中,第一丝线的卷绕远端和第二丝线的卷绕远端每一个包括相同数量的环圈,并且其中从所述第一和第二结构元件的各自的展伸接合结构顺次脱离该第一和第二结构元件的步骤进一步包括在两个步骤中促动一促动装置以顺次轴向移动该第一和第二丝线。
8.如权利要求2所述的方法,其中,第一丝线的卷绕远端和第二丝线的卷绕远端每一个包括相同数量的环圈,并且其中从所述第一和第二结构元件的各自的展伸接合结构顺次脱离该第一和第二结构元件的步骤进一步包括促动第一促动装置以轴向移动第一丝线,然后促动第二促动装置以轴向移动第二丝线。
9.如权利要求1所述的方法,进一步包括附着递送系统的其它展伸接合结构到展伸装置的其它相应的结构元件,然后在展伸装置推进到植入位置之后以及在第一和第二结构元件从它们各自的展伸接合结构脱离之后从该其它展伸接合结构的各自的结构元件顺次脱离该其它的展伸接合结构的步骤。
10.如权利要求2所述的方法,其中,所述递送系统进一步包括多个套筒,其中每一丝线至少部分地定位在所述套筒之一中,并且其中所述丝线能够相对于它们定位在其中的所述套筒轴向移动以致使丝线的卷绕远端接触套筒的远端并解绕以从它们各自的结构元件脱离。
11.如权利要求10所述的方法,其中,所述套筒的至少一个具有与所述多个套筒的其余套筒不同的长度。
12.如权利要求1所述的方法,其中,所述展伸装置进一步包括假体瓣膜。
13.如权利要求1所述的方法,其中,所述第一和第二展伸接合结构每个包括具有远端的丝线,所述远端包括钩子部分用于分别与所述展伸装置的所述第一和第二结构元件接合。
14.如权利要求1所述的方法,其中,所述第一和第二展伸接合结构每个包括一缝合部,该缝合部安置用于分别与所述展伸装置的所述第一和第二结构元件接合。
15.一种布置可植入展伸装置在患者的解剖位置的方法,包括步骤:
提供在其远端包括多个展伸接合结构的递送系统;
提供包括多个结构元件的展伸装置;
接合所述展伸装置的每一结构元件和所述展伸接合结构之一;
将所述展伸装置推进到植入位置;以及
从所述递送系统的各自的展伸接合结构顺次脱离所述展伸装置的所述结构元件。
16.如权利要求15所述的方法,其中,从所述结构元件的各自的展伸接合结构顺次脱离所述结构元件的步骤进一步包括脱离第一组结构元件,然后脱离第二组结构元件,其中所述第一和第二组结构元件每一个包括至少两个结构元件。
17.如权利要求16所述的方法,其中,从展伸接合结构顺次脱离所述结构元件的步骤包括从所述第一和第二组结构元件的各自的展伸接合结构径向脱离该第一和第二组结构元件。
18.如权利要求15所述的方法,其中,所述多个展伸接合结构的每一个包括具有远端的丝线,该远端是卷曲的用于与所述展伸装置的所述结构元件之一接合。
19.如权利要求18所述的方法,其中所述递送系统进一步包括多个套筒,所述多个套筒的每一个至少部分地围绕所述丝线之一,其中所述丝线能够相对于它们定位其中的套筒轴向移动。
20.如权利要求19所述的递送系统,其中所述套筒的至少一个具有与所述其它套筒的至少一个不同的长度。
21.如权利要求18所述的递送系统,其中,每一丝线的所述卷绕远端能够至少临时变形用于接合和脱离所述展伸装置的所述结构元件。
22.一种用于递送可植入展伸装置到患者的内腔的递送系统,所述递送系统包括:
具有近端和远端的管状体,以及
从该管状体的远端延伸的多个丝线,其中每一丝线包括卷绕的远端用于接合所述可植入展伸装置的展伸器。
23.如权利要求22所述的递送系统,进一步包括延伸通过所述管状体的至少一部分的中心支柱,其中每一丝线的近端附着到该中心支柱。
24.如权利要求23所述的递送系统,其中,所述中心支柱能够大致沿着所述管状体的纵轴线性移动。
25.如权利要求24所述的递送系统,其中,所述中心支柱包括从所述递送系统的近端向着所述递送系统的远端延伸的第一部分,以及可移除地附着到该第一部分的第二部分,其中该第二部分包括多个丝线。
26.如权利要求22所述的递送系统,其中,所述多个丝线的每一个具有相同的长度。
27.如权利要求22所述的递送系统,其中,所述多个丝线的至少一个具有与所述丝线的其它丝线不同的长度。
28.如权利要求22所述的递送系统,其中,所述多个丝线的每一个的远端具有相同数量的环圈。
29.如权利要求28所述的递送系统,其中,所述丝线的至少一个的整体长度与所述多个丝线的其它丝线的整体长度不同。
30.如权利要求22所述的递送系统,其中,所述丝线的至少一个的远端具有与所述多个丝线的其它丝线不同数量的环圈。
31.如权利要求22所述的递送系统,其中,所述多个丝线的至少一个由成形记忆材料形成。
32.如权利要求22所述的递送系统,其中,所述多个丝线的至少一个由高张力弹簧材料形成。
33.如权利要求22的所述递送系统,其中所述多个丝线的至少一个由延展性材料形成。
34.如权利要求22所述的递送系统,进一步包括多个套筒,所述丝线的每一个至少部分定位在所述套筒之一内,并且所述丝线能够相对于它们定位在其中的套筒轴向移动。
35.如权利要求34所述的递送系统,其中所述套筒的至少一个具有与其它套筒的至少一个不同的长度。
36.如权利要求34所述的递送系统,其中,每个丝线的卷绕远端的外径比它定位在其中的套筒的开口更大以使得每个丝线的远端在处于其卷绕构型时不能轴向移动到它各自的套筒中。
37.如权利要求36所述的递送系统,其中,每个丝线的远端能够在当它处于其卷绕构型时轴向移动到它各自的套筒中。
38.如权利要求22所述的递送系统,其中,所述丝线的所述卷绕远端能够至少临时变形以与展伸心脏瓣膜的展伸冠接合和脱离。
39.如权利要求22所述的递送系统,进一步包括至少部分围绕所述管状体定位的鞘,其中所述管状体和鞘能够相对于彼此从其中丝线的卷绕末端延伸超过鞘的远端的第一位置移动到其中至少一个丝线的卷绕末端接触所述鞘的远端的第二位置。
40.一种用于递送展伸假体心脏瓣膜到患者的内腔的递送系统的盒,该盒包括圆柱主体部分和多个从所述圆柱主体的远端延伸的丝线,其中所述多个丝线的每一个包括卷绕的远端用于与展伸假体瓣膜的展伸器接合,并且其中所述盒能够接合递送系统的远端。
41.一种通过递送系统布置可植入展伸装置的方法,所述递送系统包括具有近端和远端的管状体以及从所述管状体的远端延伸的多个丝线,其中每一丝线包括卷绕的远端用于接合可植入展伸装置的展伸器,该方法包括步骤:
提供包括至少一个展伸接合部件的可植入展伸装置;
接合所述多个丝线的至少一个卷绕远端与所述展伸接合部件的其中之一;
定位所述可植入展伸装置在植入位置;
相对于所述管状体轴向移动所述多个丝线的至少其中之一以从丝线所接合的展伸接合部件脱离丝线的卷绕远端。
42.如权利要求41所述的方法,其中,轴向移动所述多个丝线的至少一个的步骤进一步包括轴向移动至少一个丝线直到它的卷绕末端首先接触管状体的远端,然后至少部分解绕并从展伸接合部件脱离。
43.如权利要求41所述的方法,其中,轴向移动所述多个丝线的至少一个的步骤进一步包括从它们接合的各自的展伸接合部件的卷绕远端顺次脱离第一丝线然后脱离第二丝线。
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US20090192585A1 (en) | 2009-07-30 |
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CN101980670B (zh) | 2014-04-23 |
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JP5628688B2 (ja) | 2014-11-19 |
US20090198316A1 (en) | 2009-08-06 |
US20140142680A1 (en) | 2014-05-22 |
US11607311B2 (en) | 2023-03-21 |
AU2009206672A1 (en) | 2009-07-30 |
US20210361425A1 (en) | 2021-11-25 |
US20210315693A1 (en) | 2021-10-14 |
US11083573B2 (en) | 2021-08-10 |
EP2254515A1 (en) | 2010-12-01 |
US8157853B2 (en) | 2012-04-17 |
US10758343B2 (en) | 2020-09-01 |
US20160296327A1 (en) | 2016-10-13 |
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