CN110433387B - 带有弹性体横截面部分的可膨胀鞘管 - Google Patents

带有弹性体横截面部分的可膨胀鞘管 Download PDF

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CN110433387B
CN110433387B CN201910873465.0A CN201910873465A CN110433387B CN 110433387 B CN110433387 B CN 110433387B CN 201910873465 A CN201910873465 A CN 201910873465A CN 110433387 B CN110433387 B CN 110433387B
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sheath
wall portion
rigid wall
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P·周
E·布尔曼
Y·高
B·边
Y·M·朱
D·D·威廉姆斯
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Edwards Lifesciences Corp
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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
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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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2250/0018—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 elasticity, stiffness or compressibility
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M25/0668—Guide tubes splittable, tear apart

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Abstract

本发明涉及带有弹性体横截面部分的可膨胀鞘管。一种用于使植入物递送导管诸如用于递送人工心脏瓣膜的导管通过的可膨胀引导鞘管。可膨胀鞘管平衡鞘管中的各种刚性和弹性结构的数量、形状和位置以选择性地规划鞘管的膨胀性和屈曲刚度。可膨胀鞘管能够包括例如可膨胀管状层，可膨胀管状层包括单个径向厚度的交替的刚性和弹性壁部分。刚性和弹性壁部分的组合允许推进可膨胀鞘管的扭矩和推动强度，同时适应暂时膨胀。可膨胀鞘管还能够用管状的编织纤维层或支架结构来增强以获得附加强度。其他实施例包括在刚性壁部分的远端处选择性使用狭槽或间隙以提高膨胀性并且分布应变。

Description

带有弹性体横截面部分的可膨胀鞘管
本申请是国际申请日为2015年12月14日、进入国家阶段日为2017年9月25日的名称为“带有弹性体横截面部分的可膨胀鞘管”的中国专利申请2015800782035(PCT/US2015/065578)的分案申请。
背景技术
血管内递送导管组件用于在身体内的通过外科手术不易接近/进入(access)或者期望在无需侵入性外科手术的情况下接近的位置处植入假体设备，诸如人工瓣膜。例如，主动脉瓣、二尖瓣、三尖瓣，和/或肺部人工瓣膜能够使用微创外科技术递送到治疗部位。
引导鞘管能够用于将递送装置安全地引入患者的脉管系统(例如，股骨动脉)中。引导鞘管通常具有插入脉管系统中的细长套管和包括一个或多个密封阀的壳体，所述一个或多个密封阀允许递送装置被放置成在最小限度失血的情况下与脉管系统流体连通。常规的引导鞘管通常需要管状装载器插入通过壳体中的密封件以为安装在球囊导管上的阀提供通过壳体的无障碍路径。常规的装载器从引导鞘管的近端延伸，并且因此减小了能够插入通过鞘管并且进入身体的递送装置的可用工作长度。
在引入递送系统之前接近血管(诸如，股骨动脉)的常规方法包括使用直径逐渐增加的多个扩张器或鞘管扩张血管。这种重复插入和血管扩张会增加手术所花费的时间量并且增加对血管损害的风险。
已经公开了径向膨胀的血管内鞘管。此类鞘管趋于具有复杂的机构，诸如棘爪机构，一旦引入直径比鞘管的原始直径大的设备，该机构就将轴或鞘管保持在膨胀配置中。
然而，将假体设备和其他材料递送到患者体内和/或从患者体内移除假体设备和其他材料仍对患者构成风险。此外，由于递送系统的在插入期间会引起血管的纵向和径向撕裂的相对较大的轮廓，所以接近血管仍然是一种挑战。递送系统能够另外地去除血管内的钙化斑块，从而构成由所去除的斑块引起的附加的血块风险。
题为“EXPANDABLE SHEATH FOR INTRODUCING AN ENDOVASCULAR DELIVERYDEVICE INTO A BODY(用于将血管内递送设备引入身体中的可膨胀鞘管)”并且通过引用并入本文的美国专利No.8,790,387例如在‘837的图27A和图28中公开了带有分离的外聚合物管状层和内聚合物层的鞘管。内聚合物层的一部分延伸通过由切口产生的间隙并且能够在外聚合物管状层的部分之间被压缩。在鞘管膨胀时，外聚合物管状层的部分已经彼此分离，并且内聚合物层膨胀为基本上圆柱形的管。有利地，‘387专利中公开的鞘管能够暂时膨胀以用于可植入设备通过并且然后恢复到其起始直径。
虽然存在‘387专利的公开，但是仍然需要进一步改进用于植入瓣膜和其他假体设备的血管内系统的引导鞘管。
发明内容
本文公开了一种用于使植入物递送导管(诸如用于递送人工心脏瓣膜的导管)通过的可膨胀引导鞘管。可膨胀鞘管能够通过允许可膨胀鞘管的一部分暂时膨胀以容纳递送导管然后一旦植入物穿过就恢复到原始直径来最小化对血管的创伤。通常，本文公开了平衡鞘管中的各种刚性和弹性结构的数量、形状和位置以选择性地规划鞘管的膨胀性和屈曲(buckling)刚度的各种实施例。可膨胀鞘管能够包括例如可膨胀管状层，该可膨胀管状层包括单个径向厚度的交替的刚性和弹性壁部分。刚性和弹性壁部分的组合允许获得扭矩和推动强度以推进可膨胀鞘管，同时适应暂时膨胀。可膨胀鞘管还能够用管状的编织纤维层或支架结构来增强以获得附加强度。其他实施例包括在刚性壁部分的远端处选择性使用狭槽或间隙以提高膨胀性并且分布应变。
一个实施例的鞘管包括布置成可膨胀管状层的至少一个刚性壁部分和弹性壁部分。刚性壁部分具有刚性壁径向厚度，并且大体上平行于且部分地围绕鞘管的细长轴线延伸并且限定至少两个边缘。两个边缘大体上轴向地并且在刚性壁部分的内表面和外表面之间延伸。刚性壁部分的弹性壁径向厚度等于刚性壁径向厚度，并且大体上平行于且部分地围绕细长轴线延伸。弹性壁部分在刚性壁部分的边缘之间延伸以便限定在任一横截面处均具有一致的径向厚度的可膨胀管状层。可膨胀管状层具有小于植入物的起始轮廓并且限定管腔。可膨胀层被配置成至少在弹性壁部分处暂时膨胀以允许植入物通过管腔。可膨胀层然后在植入物通过管腔之后恢复到其原始形状以接近起始轮廓。
在另一方面，至少一个刚性壁部分包括多个刚性壁部分。并且，至少一个弹性壁部分包括多个弹性壁部分。刚性和弹性壁部分能够围绕细长轴线周向地交替。另外，鞘管能够包括围绕可膨胀管状层延伸的弹性外管状层。鞘管还能够包括中间管状层，该中间管状层包括在可膨胀管状层和外管状层之间延伸的多个编织纤维。编织纤维还能够形成可膨胀网状物，其中弹性外管状层层压到中间管状层上。鞘管还能够包括低摩擦管状层，该低摩擦管状层涂覆可膨胀管状层的内表面。纤维能够彼此大体上垂直延伸以形成可膨胀网状物。
在另一方面，刚性壁部分中的每个的两个边缘能够平行于细长轴线延伸。此外，刚性和弹性壁部分能够是可膨胀管状层的弧段。
在另一实施例中，鞘管包括限定可膨胀管状层的刚性壁部分和弹性壁部分。刚性壁部分大体上平行于并且部分地围绕鞘管的细长轴线延伸并且限定至少两个边缘。两个边缘大体上轴向延伸地并且在刚性壁部分的内表面和外表面之间延伸。弹性壁部分大体上平行于并且部分地围绕细长轴线延伸。弹性壁部分在刚性壁部分的边缘之间延伸以便限定可膨胀管状层。可膨胀管状层具有小于植入物的起始轮廓并且限定管腔。并且，可膨胀管状层被配置成至少在弹性壁部分处暂时膨胀以允许植入物通过管腔并且在植入物通过管腔之后恢复到接近起始轮廓。弹性壁部分(或多个部分)能够包括可膨胀管状层的45度至90度的轴向横截面。
鞘管还能够包括耦接到弹性壁部分的内表面并且大体上平行于细长轴线延伸的一个或多个细长杆。刚性壁部分和细长杆能够具有光滑内表面，该光滑内表面被配置成有利于植入物通过。弹性壁部分还能够是外弹性管状层的一部分，并且刚性壁部分能够嵌入外弹性管状层中。可膨胀管状层的由弹性壁部分限定的管腔能够比由刚性壁部分限定的管腔大。
在另一方面，多个细长杆耦接到弹性壁部分的内表面和刚性壁部分的内表面。细长杆大体上平行于细长轴线延伸并且向内延伸到管腔中。细长杆还能够围绕可膨胀管状层的管腔周向地间隔开。
在另一实施例中，鞘管包括弹性管状层和嵌入弹性管状层中的至少一个刚性壁。刚性壁的近侧部分限定至少一个第一纵向延伸间隙，并且远侧部分限定至少一个第二纵向延伸间隙。至少一个第一纵向延伸间隙的累加周向大小小于至少一个第二纵向延伸间隙的累加周向大小。鞘管具有小于植入物的起始轮廓并且限定管腔。鞘管被配置成在至少一个第一纵向间隙和至少一个第二纵向间隙处暂时膨胀以允许植入物通过管腔，并且然后在植入物通过管腔之后恢复到接近起始轮廓。
第二纵向延伸间隙能够从第一纵向延伸间隙的远端延伸。
另外，鞘管能够包括为第一间隙两倍的第二间隙。第一纵向延伸间隙中的每个的远端能够延伸到第二纵向延伸间隙中对应的一个的近端。在另一方面，鞘管能够包括六个第二纵向延伸间隙。
至少一个第二纵向延伸间隙能够包括具有向远侧逐渐增加的累加周向大小的至少一部分。
在另一方面，鞘管包括线性延伸并且限定多个刚性壁指状件的多个第二纵向间隙。
附图说明
图1是递送导管组件的分解侧视图；
图2是本发明的一个实施例的鞘管的横截面图；
图3是图2的鞘管的局部分解图；
图4是图2的鞘管的远端的放大视图；
图5是图2的鞘管的近端的放大视图；
图6A是另一实施例的鞘管的放大视图，其中囊状件(capsule)从中穿过；
图6B是图6A的鞘管的横截面图；
图7是另一实施例的鞘管的横截面图；
图8A是接近远端区域弹性增加的递送鞘管的另一实施方式的示意图；
图8B至图8D是图8A所示的递送鞘管实施方式的横截面示意图；
图9A是接近远端区域弹性增加的递送鞘管的另一实施方式的示意图；
图9B至图9D是图9A所示的递送鞘管实施方式的横截面示意图；
图10A是接近远端区域弹性增加的递送鞘管的另一实施方式的示意图；
图10B至图10D是图10A所示的递送鞘管实施方式的横截面示意图；
图11A是接近远端区域弹性增加的递送鞘管的另一实施方式的示意图；
图11B至图11D是图11A所示的递送鞘管实施方式的横截面示意图；
图12A是接近远端区域弹性增加的递送鞘管的另一实施方式的示意图；
图12B至图12D是图12A所示的递送鞘管实施方式的横截面示意图；
图13是本发明的另一实施例的将两个鞘管组装成组合鞘管的示意图；
图14至图16是具有可膨胀薄壁节段的鞘管的实施例的横截面图；
图17至图19是具有增强可膨胀壁管的丝或带的鞘管的实施例的横截面图；
图20是用于本发明的另一实施例的鞘管的端部的支架的局部透视图；且
图21至图23是具有逐渐打开以增加其管腔直径的远侧支架部分的鞘管的刚性壁结构的实施例的透视图。
具体实施方式
本发明构思的某些示例的以下描述不应当用于限制权利要求的范围。从以下描述中，其他示例、特征、方面、实施例以及优点将对本领域技术人员显而易见。如将被意识到的，设备和/或方法能够具有其他不同且明显的方面，所有这些均不偏离本发明构思的精神。因此，附图和描述应被视为本质上是说明性的而非限制性的。
出于本说明书的目的，本文描述了本公开的实施例的某些方面、优点和新颖特征。所述方法、系统和装置不应被解释为以任何方式进行限制。相反，本公开涉及各种所公开的实施例的所有新颖的且非显而易见的特征和方面，这些特征和方面是单独地和彼此呈各种组合和子组合。所公开的方法、系统和装置不限于任何具体的方面、特征或其组合，所公开的方法、系统和装置也不要求存在任何一种或多种具体的优点或解决任何一个或多个问题。
结合本发明的特定的方面、实施例或示例所描述的特征、整数、特性、化合物、化学成分或组应当被理解为适用于本文所述的任何其他方面、实施例或示例，除非与其相矛盾。本说明书(包括任何所附权利要求、摘要和附图)中公开的所有特征，和/或所公开的任何方法或过程的所有步骤可以以任何组合方式进行组合，除了此类特征和/或步骤中的至少一些相互排斥的组合外。本发明不限于任何前述实施例的细节。本发明延伸到本说明书(包括任何所附权利要求、摘要和附图)中所公开的特征的任何新颖的特征或任何新颖的组合，或延伸到所公开的任何方法或过程的步骤的任何新颖的步骤或任何新颖的组合。
应当理解，被称为通过引用并入本文的全部或部分的任何专利、出版物或其他公开材料是仅在所并入的材料不与本公开中阐述的现有的定义、陈述或其他公开材料冲突的程度上并入本文的。由此并且在必要的程度上，如本文明确阐述的公开内容取代通过引用并入本文的任何冲突材料。被称为通过引用并入本文但是与本文所阐述的现有的定义、陈述或其他公开材料冲突的的任何材料及其部分仅在所并入的材料和现有的公开材料之间没有出现冲突的程度上被并入。
如说明书和所附权利要求书中所用的，单数形式“一个/种”以及“该”包括复数指示物，除非上下文另外清楚地指示。范围在本文可被表示为从“约”一个特定值和/或到“约”另一特定值。当表述此范围时，另一方面包括从该特定值和/或到另一特定值。类似地，当值通过使用先行词“约”被表示为近似值时，应当理解特定值形成另一方面。还应理解，范围中的每个的端点无论是与另一端点相关还是独立于另一端点都是有意义的。
“可选的”或“可选地”意指随后描述的事件或情况可发生或可不发生，并且该描述包括所述事件或情况发生的情形和不发生的情形。
贯穿本说明书的描述和权利要求书，词语“包括”和该词语的变型诸如“包含”和“涵盖”意指“包括但不限于”，并且并非旨在排除例如其他添加物、部件、整数或步骤。“示例性的”意指“…的示例”并且并非旨在传达优选或理想方面的指示。“诸如”不用于限制性的意义而是用于说明的目的。
本文公开了用于使植入物递送导管(诸如用于递送人工心脏瓣膜的导管)通过的可膨胀引导鞘管。可膨胀鞘管能够通过允许可膨胀鞘管的一部分的暂时膨胀以容纳递送导管然后一旦植入物穿过就恢复到原始直径来最小化对血管的创伤。通常，本文公开了平衡鞘管中的各种刚性和弹性结构的数量、形状和位置以选择性地规划鞘管的膨胀性和屈曲刚度的各种实施例。可膨胀鞘管能够包括例如可膨胀管状层，该可膨胀管状层包括单个径向厚度的交替的刚性和弹性壁部分。刚性和弹性壁部分的组合允许获得扭矩和推动强度以推进可膨胀鞘管，同时适应暂时膨胀。可膨胀鞘管还能够用管状的编织纤维层或支架结构来增强以获得附加强度。其他实施例包括在刚性壁部分的远端处选择性使用狭槽或间隙以提高膨胀性并且分布应变。
本文公开了特别适用于递送呈可植入心脏瓣膜(诸如球囊可膨胀的可植入心脏瓣膜)形式的植入物的细长的递送鞘管。球囊可膨胀的可植入心脏瓣膜是公知的并且在此将不详细描述。在美国专利N0.5,411,552并且还在美国专利申请公开No.2012/0123529中描述了这种可植入心脏瓣膜的示例，上述两个专利均通过引用并入本文。本文所公开的细长的递送鞘管也可用于递送其他类型的植入设备，诸如自膨式可植入心脏瓣膜、支架或过滤器。如本文所用的术语“植入物”和“可植入物”广义上被定义为意指递送到身体内的部位的任何东西-假体的或非假体。例如，诊断设备可为可植入物。
如本文所用的术语“管”或“管状的”并非意味着将形状限制为圆形横截面。相反，管或管状的能够指带有封闭的横截面和轴向延伸通过其的管腔的任何细长结构。管在其中还能够具有一些选择性定位的狭缝或开口-但是管仍提供足够的封闭结构以将其他部件包括在其(多个)管腔内。
图1示出递送导管组件1，其包括带有管腔的细长的可膨胀递送鞘管3，以引导支撑假体植入物5(诸如人工心脏瓣膜)的植入物递送导管通过。在近端处，鞘管3包括防止加压的血液泄露的止血阀和用于与鞘管3连接的接口(hub)4。递送导管组件1能够包括可转向的导向导管7(也被称为挠曲导管)和延伸通过导向导管7的球囊导管9。递送导管组件1还能够包括囊状件13，囊状件13具有增大的直径以保持安装在球囊导管9的球囊上的植入物5。
通常，在使用期间，鞘管3穿过患者的皮肤(通常在导丝上)使得鞘管3的远端区域插入血管(诸如，股骨动脉)中，并且然后推进到手术部位-诸如在主动脉弓上推进到自体主动脉心脏瓣膜。球囊导管和囊状件13的鼻部在鞘管3的近端处插入通过止血阀。可转向的导向导管7用于推进球囊导管11和囊状件13的鼻部通过鞘管3的端部并且使其自该端部离开。然后，植入物5被推出囊状件13并且诸如通过球囊充气或通过自膨胀而膨胀到自体心脏瓣膜中。
本文所示的递送鞘管的实施方式能够为需要瞬时膨胀的其他植入物和递送装置提供通路，以有利于使植入物或递送装置的部分通过。例如，在一些实施方式中，递送鞘管能够用于递送过大的球囊导管用于血管再成形术手术。如本文所用的术语“植入物”无需是永久的植入物-例如，球囊暂时是植入物-而是能够是递送到身体中以用于进行手术的任何设备。
图2至图5示出包括壁结构和限定在其间延伸的管腔32的鞘管3的一个实施例，壁结构在其远端上具有尖端28并且在其近端30上具有张开部分。壁结构包括外弹性层20、中间网孔层22、混合的可膨胀层24和内光滑低摩擦衬垫或层26。通常，张开的近端30的大小和形状设定为接收接口结构的远侧凸端，除了别的以外，该接口结构还包括在递送导管插入通过递送鞘管3的管腔32期间调节泄露的止血阀。鞘管3的大小能够设定为用于递送呈例如安装在支架上的软组织心脏瓣膜形式的假体植入物。对于此应用，鞘管能够具有0.260英寸的外径和0.215英寸的内径。这些直径能够随植入物的大小和/或植入物或其他应用的类型而变化。
如图4所示，具有渐缩的圆柱形构造的远侧尖端28具有近侧锥部34、远侧锥部36、内表面38和圆形前缘40。近侧锥部34相对于外弹性层20的平行的外壁成相对微小的角度。通常，尖端在近侧锥部的远端处具有约0.25英寸的外径并且在近侧锥部34的近端处具有约0.26英尺的外径。远侧锥部36具有增至约20度的较大的角度。远侧锥部36具有约0.060英寸的长度。前缘40具有约0.01英寸的圆角半径。前缘的最外直径为0.206英尺并且最内直径为0.187英尺。
内表面38支撑混合的可膨胀层24和内光滑层26的逐渐变薄的向远侧渐缩部分-其中这些层在远侧方向上变得更薄。层24和26的内表面和远侧渐缩部分一起限定植入物5和囊状件13能够通过其离开的管腔32的远侧部分。
在远侧尖端28的近端处，远侧尖端28包括内环形表面42和外环形表面44。内环形表面凹入远侧尖端28的近端内，并且外环形表面在远侧尖端28的最近侧边缘上。内环形表面42被配置成接收并邻接网孔层22的远侧边缘，并且外环形表面44被配置成邻接外弹性层20的远侧边缘。
当组装到层20、22、24和26的远端时，由相对平滑的刚性材料构成的远侧尖端28为鞘管3的远端的推进提供支撑。在推进通过体腔时，锥部和圆形外边缘最小化创伤。另外，在植入物3和囊状件13通过之后，远侧尖端28有助于保持鞘管3的端部直径。
外层20具有管状形状并且优选地由软弹性体材料诸如PEBAX或聚醚嵌段酰胺材料构成，以便响应于力而容易膨胀并且恢复到其原始尺寸。另外，弹性体特性促使更多的内层缩回到它们的原始形状。外层能够具有0.260英寸的外径并且是组成鞘管3的层的最大直径。外层20围绕延伸通过其管腔的网孔层22延伸并且层压到网孔层22上。
网孔层22优选地由织物形成，该织物由从编织或针织构造中获得柔性和一些推动刚度的弹性较低的成分组成。例如，网孔层能够由编织成带有多孔开口的柔性网状物或套管或管的PET(聚对苯二甲酸乙二醇酯)绳或线材料构成以促进膨胀并且增强柔性。网孔层22能够形成为多个编织纤维。例如，图3示出网孔层22的一个实施例的管状形状，其中一组线垂直于另一组线延伸。丝或金属也能够用于构造网孔层22，诸如具有高弹性应变极限的编织的超弹性镍钛诺丝。
图5示出鞘管3的张开的近端的横截面。同远端一样，近端包括外弹性层20、中间网孔层22、混合的可膨胀层23和内光滑衬垫或层26。最近侧区域具有比鞘管3的剩余部分宽的第一环形部分17。层20、22、24和26从近端30的第一环形部分向远侧移动而急剧变窄，从而形成肩部21。肩部21和第一环形部分17被配置成连接到递送系统1的接口4。从肩部21向远侧移动，这些层向远侧延伸以形成第二环形部分19。第一环形部分17和第二环形部分19的壁基本上平行于鞘管3的纵轴2延伸，并且第二环形部分19延伸比第一环形部分17大的距离。从第二环形部分19向远侧移动，层20、22、24和26再次变窄以形成锥部23。相比肩部21，锥部23与纵轴2成更小的角度。相比肩部21，锥部23还沿纵轴2延伸更大的距离。
再次参考图3，混合的可膨胀层24由包括软部分46和硬部分48的交替的全厚度部分的混合物构成。软部分46由向可膨胀层24提供弹性的弹性体材料-诸如，类似于外层20的材料-构成。硬部分48由相对刚性材料构成，并且从而为克服体腔的阻力推进鞘管3提供一些柱状稳定性。部分46和48的数量和间隔能够根据应用来调整。能够包括更大数量或尺寸的刚性部分48以获得更大的刚度。能够包括更大数量或尺寸的软/弹性体部分46以获得改进的膨胀性和柔性。TECOFLEX(一种脂肪族聚醚型聚氨酯)是一种能够用于刚性部分48的材料。
这些部分围绕层24的圆周具有相等的从内径到外径的径向厚度。另外，这些部分中的每个包括在硬部分和软部分之间的在层24的内表面和外表面之间延伸的一对边缘25。所述对边缘还能够与鞘管3的长轴平行地纵向延伸。软/弹性体部分46与硬部分48以弧段交替，它们的边缘邻接附接，以形成混合的可膨胀层24的管状结构(带有一致的或恒定的壁厚)。硬弧段和软弧段能够大小相等，或者它们的大小能够变化。
内光滑层26涂覆可膨胀层24的内表面或附贴在其上。层26优选为低摩擦层(诸如，PTFE)并且能够包括将光滑材料附接到可膨胀层24的连接层(tie-layer)。有利地，包括弹性外层、网孔层和交替的硬/弹性体层的三个层的复合以及内光滑衬垫能够为植入物的通过提供刚度、膨胀/恢复和低阻力的良好平衡。
图6A示出本发明的另一实施例的递送鞘管3，其中囊状件13承载安装在支架上的心脏瓣膜或其他假体植入物5穿过鞘管的管腔32。(例如，植入物能够是29mm的安装在支架上的人工心脏瓣膜)。囊状件13在近侧到远侧的方向上穿过。如本文所用的，“远侧”(图6A中标记为“D”)意指朝向植入部位，并且“近侧”(在图6A中标记为“P”)意指远离植入部位。递送鞘管3能够包括透明或半透明材料，通过该材料能够看见囊状件13。通常，图6A和图6B的鞘管显示出暂时膨胀以使植入物5通过并且然后恢复到其标准直径的能力。另外，鞘管3能够包括多个杆50，多个杆50能够通过鞘管看见并且有利于囊状件13较低摩擦地通过。
图6B示出包括刚性壁部分52、弹性壁部分54和杆50的递送鞘管3的横截面。刚性壁部分52具有部分圆形或弧形或C形横截面，其中横截面内具有一致的壁厚。刚性壁部分的C形状具有一对边缘56，这对边缘56在刚性壁部分52的内表面和外表面之间延伸。两个边缘大体沿刚性壁部分52的长度并且在递送鞘管3的细长轴线的方向上并且平行于细长轴线垂直于横截面延伸。
弹性壁部分54在刚性壁部分52的自由边缘56之间延伸以限定可膨胀管状层并且封闭鞘管3的管腔32。如图6B所示，弹性壁部分通常具有比刚性壁部分52短的弧长，并且比刚性壁部分52的内表面更径向远离鞘管3的轴线定位。这种附加的径向空隙为三个杆50提供空间以使它们延伸到管腔32中。弹性壁部分54能够包括鞘管3的横截面的至少20度或多达45度至90度的角度58。弹性壁部分54和刚性壁部分52的组合和比例在植入物5通过期间提供了管腔直径32的暂时膨胀和恢复。
弹性壁部分54能够是外弹性管状层62的在外部将刚性壁部分52封装在无缝弹性体层中的一部分。以这种方式，弹性管状层62有助于封闭管腔32并且当其不再处于来自穿过的植入物的压力下时促使C形刚性壁部分52回到其原始直径。虽然图6A和图6B的鞘管能够具有一定范围的尺寸以适应不同的应用，但是出于人工瓣膜递送的目的，刚性壁部分52的厚度能够在0.002英寸到0.020英寸的范围内，包括约0.015英寸。弹性管状层62的外部添加约另外的0.002英寸至0.020英寸，并且特别是添加约0.005英寸。在一个应用中，鞘管3的总厚度能够约为0.020英寸。未膨胀的管腔32能够具有从0.050英寸至0.250英寸诸如0.156英寸的直径。
图6B示出嵌入到弹性壁部分54中并且延伸到鞘管3的管腔32中的杆50中的三个杆。杆50是带有挤压横截面-诸如，带有圆形横截面的圆柱形形状-的沿鞘管3的纵轴延伸的细长结构。图6B的杆50在C形刚性壁部分52的边缘56之间在周向方向上彼此等距地间隔开。有利地，如图6A所示，在囊状件13通过期间，杆50的间隔能够随着弹性壁部分54的拉伸而增加。因此，杆能够提供一些附加刚度并且减小表面积和原本将存在于弹性壁部分和穿过的植入物或囊状件之间的摩擦力，而对鞘管的膨胀性没有很大的影响。如能够看出的，杆50的横截面的至少约一半延伸到管腔32中。
C形刚性壁部分52能够由一定范围的刚性材料组成，诸如向鞘管3提供屈曲阻力、可推动性、可扭转性和相对刚性主体的高密度聚乙烯或尼龙。弹性体软部分46的组合有助于调节鞘管的扭结并且有助于抵抗刚性壁部分52的打开趋势。包括壁部分52、54和外弹性管状层62的可膨胀管状层的近端能够张开以提供接口附接。另外，尖端能够由与壁部分54相同的弹性体材料构成。尖端能够包括不透射线的特性并且能够热熔到外管状层62。制造相当容易，这是因为鞘管3的部件能够在单个操作中共同挤压而成。
图7示出包括壁部分52、54和杆50的与图6A和图6B中的鞘管3类似的鞘管3的另一实施例。然而，在该实施例中，刚性壁部分52的边缘56被定向成在在共同的平面内。与具有封装的外弹性管状层62相反，弹性壁部分54还具有与刚性壁部分52匹配的厚度。相比图6A和图6B所示的实施例，弹性壁部分54占去更大的角度58。
鞘管3还包括更大数量的杆50，杆50围绕整个管腔32周向地等距间隔开。杆50连接到刚性壁部分52和弹性壁部分54两者的内表面。杆50具有半圆形挤压的横截面。附加的杆50能够进一步减小接触面积和相关联的摩擦。杆50能够由刚性的、相对光滑的材料组成以进一步有利于滑动。由于杆有利于增加刚度，刚性壁部分52的杆50能够允许减小壁部分的总刚度。
图8A至图8D示出一个实施例，其中鞘管3包括弹性管状层66，弹性管状层66覆盖一个或多个刚性壁部分68。弹性管状层66能够是防止血液或流体泄露的无缝外层。刚性壁部分限定一个或多个间隙70。通常，由间隙70占去的横截面的累加周向量与鞘管3在该特定纵向位置处的膨胀阻力成比例。例如，图8A至图8D示出向远侧增加的间隙70的累加量，使得在植入物上施加的压缩量在远侧方向上下降。这能够是有利的，因为在鞘管内推进囊状件13的摩擦力和/或其他阻力能够随着行进距离的增加而增加-膨胀阻力的下降能够稍微抵消增加的推动阻力。
例如，图8D所示的横截面是从较近侧位置截取的，并且所嵌入的刚性壁部分68占去明显多于鞘管3的圆周的一半的圆周。刚性壁部分68的端部之间的单个间隙70为形成类似于上述刚性壁部分52的C形管的约45度的圆周。向远侧移动到图8C所示的横截面示出添加到较大间隙的附加的一组四个较小的间隙70。如图8A所示，这些间隙旨在将刚性壁部分68限定为离散的指状件74。随着间隙大小与刚性壁部分68的大小成比例地增加，鞘管3的膨胀刚度下降。图8B所示的横截面在远端处并且现在不存在刚性壁部分68，从而大大增加鞘管3的远端的膨胀性。
虽然图8A至图8D所示的间隙纵向延伸并且大体上彼此平行延伸，但是间隙70能够具有一定范围的大小和定位。较小的间隙周向地布置并且彼此间隔开并且与较大的间隙间隔开。整齐间隔的多个间隙70有利于弹性管状层66的均匀膨胀。整个轴向长度间隙还能够具有与其他间隙70类似的周向大小以用于更加均匀的膨胀分布。例如，对于六个间隙，C形管的300％应变分为在每个位置处50％。与此相反，带有单个间隙的尖端具有层66的更加局部的膨胀和一些断裂风险。
应当注意，如本文所用的术语“轴向的”不限于笔直的轴线，而是指纵向结构的总体的瞬时方向。换句话说，轴线随着细长结构的弯曲而弯曲。
图9A至图9D示出另一实施例，其中鞘管3具有纵向延伸的间隙70中的单个间隙和然后形成面向远侧的对角线曲面的对角线切口。对角线切口用于逐渐减少由刚性壁部分68在远侧方向上延伸时所占据的横截面的量，如图9D、图9C和图9B所示。
图10A至图10D示出另一实施例，其中鞘管包括在刚性壁部分的相对侧上的一对间隙70。这对间隙在远侧方向上膨胀，其直径在图10D的近侧横截面处最小，从而使大小逐步增加到图10C的横截面。在最终过渡时，刚性壁部分68消失以获得图10B的横截面。该型式在轴向方向上的每次过渡时提供了逐步减小的膨胀阻力。
图11A至图11D示出另一实施例，其中当刚性壁部分开始一对会聚的对角线曲面72时，间隙70中的一个消失。对角线曲面会聚到单对相对的指状件74。此外，由刚性壁部分68和间隙70占据的圆周的比例的变化调整鞘管3的远端的膨胀阻力。
图12A至图12D示出一些先前的构思的组合，其中鞘管3包括会聚到一个指状件74的对角线曲面72。
在图8A至图12D的实施例中，弹性管状层66和刚性壁部分能够独立于彼此移动以进行更自由的膨胀。这能够通过添加尖端区域76来补充，诸如通过在C形刚性壁部分68中限定间隙70的切口的远端上方回流焊(reflow)软的可膨胀管或涂层。添加尖端能够使尖端软化并且成型以更容易插入鞘管3并且保护和覆盖刚性壁部分68的远端。在图8A至图8D中，尖端区域76覆盖指状件74的纵向长度的一些或全部，而仅带有单个C形横截面(例如，图8D的横截面)的刚性壁部分的剩余部分独立于弹性管状层66以进行自由膨胀。在图9A至图12D中，尖端区域能够在限定图9D的C形横截面的单个间隙的终端的远侧开始。
虽然本文所公开的鞘管3的实施例具有特定的层构造，但是它们能够包括围绕附图所描绘的层的内部或外部延伸的附加的层。例如，在一些实施方式中，能够包括底切/板(bard)或连接层以使刚性壁部分68保持附接到弹性管状层66。在一些实施方式中，能够包括光滑的最外层。光滑的最外层能够包括增加外表面润滑性的助滑添加剂。
在一些实施方式中，诸如图6B所示的实施方式，例如由于包括共挤压、热粘合、胶或另外的固定材料的制造方法，第一层54和第二层62以及壁部分52(其为另一层)粘合在一起。共挤压的实施方式特别有利，这是因为它们制造简单又便宜。共挤压还减少外周向层与内周向层的分层。在其他实施方式中，层没有完全粘合并且至少部分地并且可能完全地可相对于彼此旋转。对于可旋转的实施方式，在植入物5穿过时所经受的周向张力围绕层20、54和66分布而不是局部化到特定的位置。这减少了使这些外层断裂的可能性。在一些实施方式中，层在鞘管3的某些长度上粘合在一起，并且可在鞘管3的其他长度上旋转。在一些实施方式中，第一和第二周向层仅在鞘管3的远端区域处粘合在一起。选择性地允许层的一些部分旋转允许获得一些改进的抗撕裂性，同时保留某个单元结构刚度。在一些实施方式中，鞘管3的近端能够张开以附接到鞘管的外部部件。
在一些实施方式中，所示实施例的各个部分能够用纵向杆50补充。杆能够部分或完全沿限定鞘管的管腔32的最内表面的长度延伸。纵向延伸杆能够例如由最内表面支撑。在此，术语“由…支撑”能够意指杆与该内表面接触或延伸通过该内表面。例如，杆能够附贴到最内表面或形成于最内表面上。在一些实施方式中，纵向延伸杆能够完全嵌入最内层中。在其他实施方式中，纵向延伸杆50能够部分嵌入该层中，并且部分突出到鞘管的内管腔中，诸如图6B所示。
纵向延伸杆50的高度和宽度并且因此致力于非弹性体部分的鞘管横截面的量能够沿鞘管3的长度变化。纵向延伸杆50的宽度43能够例如为从0.001英寸到0.05英寸。当从大体上垂直于鞘管3的细长轴线2截取的横截面观察时，杆50能够为圆形的、椭圆形的、多边形的、矩形的、正方形的或者是以上所列的形状的部分的组合。带有突出到管腔中的弯曲表面(诸如圆形或椭圆形表面)的杆50具有减小鞘管和穿过的物体之间的接触面积从而减小摩擦的优点。当鞘管处于张力下时，纵向延伸杆还最小化纵向方向上的尺寸变化。
本文描述为弹性的部件能够由弹性体诸如高弹性聚合物组成。在一些实施方式中，弹性体部分能够包括聚醚、聚氨酯、硅树脂、热塑性弹性体、橡胶诸如丁苯橡胶或以上所列的高弹性聚合物的任一种的共聚物。弹性体材料能够具有大约800％的伸长率。在一些实施方式中，弹性体部件能够包括NEUSOFT聚合物。NEUSOFT聚合物的硬度能够例如为63邵氏A硬度。NEUSOFT是带有良好弹性、振动阻尼、耐磨损性和抗撕裂性的半透明的聚醚聚氨酯基材料。聚氨酯在化学上耐水解并且适于包覆模制在聚烯烃、ABS、PC、Pebax和尼龙上。聚氨酯提供良好的隔湿层和隔氧层以及UV稳定性。
各种弹性层诸如，层20、62和66的提高的弹性有利于层从其起始轮廓膨胀以允许假体植入物5和/或递送囊状件13通过。在一些实施方式中，特别是对于包括安装在支架上的假体植入物的囊状件的通过，管腔在完全膨胀的状态下能够膨胀到0.15英寸至0.4英寸。例如，在一个实施方式中，管腔的原始直径是0.13英寸，在植入物通过期间膨胀到0.34英寸，并且紧接着在植入物通过之后收缩回到0.26英寸，并且随时间的推移继续收缩直到最终恢复到大约0.13英寸。在植入物通过之后，由于弹性体部件的弹性，所以管腔塌缩回到更窄的直径。
本文所述的实施例的非弹性体部件(有时特别描述为刚性的)由比弹性体部件的弹性小的大体上刚性材料制成。刚性部件向鞘管3提供强度以补充由弹性体部件所贡献的弹性特性。更加刚性的非弹性体部件还有助于抗屈曲性(压力下的抗破坏性)、抗扭结性(弯曲期间的抗破坏性)和扭矩(或易于使鞘管在血管内周向地转动)。用于制造刚性部件的刚性材料能够包括高密度聚乙烯(HDPE)、尼龙、聚对苯二甲酸乙二醇酯(PET)、含氟聚合物(诸如，聚四氟乙烯或PTEF)、聚甲醛(POM)或任何其他适当刚性的聚合物。非弹性体刚性部件的伸长率能够例如为大约5％。HDPE非弹性体刚性部件的硬度能够例如为约70邵氏D硬度。
非弹性体部件还能够由比弹性体材料更加光滑的材料制成，以便减小部件和/或部件和植入物5、囊状件13或其他相邻的接触物之间的摩擦。
本文所公开的实施例能够彼此组合以产生带有变化的特性的鞘管。图13示出嵌套到彼此中的两个单层管的组合。单层管中的每个包括具有C形状的刚性壁部分和围绕管腔32封闭C形状的弹性壁部分54。每个单层管还包括处于与图6B的实施例类似的配置的杆50。单层管中的一个具有更小的直径并且装配在另一管的管腔32内。这种组合的优点是弹性壁部分54更加平衡地分布在管的两侧上，这进而分布膨胀应变。本文所公开的其他实施例能够彼此嵌套以调整膨胀阻力和分布。
图14、图15和图16示出包括刚性壁部分52和弹性壁部分54的鞘管3的变型，其中与刚性壁部分52相比，弹性壁部分具有更小的壁厚以获得附加柔性。在这些实施例中，壁部分能够具有带有由于厚度减小而获得的附加柔性的相同材料。或者，减小的厚度能够与更具有弹性的材料成分结合。
图14示出鞘管3的实施例，其中C形刚性壁部分52与薄的弹性壁部分54结合。图15示出相对侧上的两个弹性壁部分54和两个厚的更加刚性的壁部分52的使用，从而将膨胀应变定位在鞘管3的相对侧上。图16示出鞘管3的实施例，其中鞘管的圆周的多于一半或2/3或3/4是减薄的弹性壁部分54。
图17、图18和图19示出其中丝78或带80能够嵌入结构82中以选择性地增强可膨胀弹性管状层81的实施例。结构82能够是纵向应用-诸如共挤压-到弹性管状层81的外表面的增厚的隆起或特征部。丝或带能够由相对较刚性的材料构成以获得选择性的增强。图17和图18示出丝78的使用，并且为了增加的强度，图19示出嵌入到结构82中的带80的使用。
图14至图19的鞘管能够如上所述制造，包括经由回流焊、胶合、粘合、焊接等。材料能够包括HDPE或TECOFLEX以用于更加刚性的部件。本文的其他材料还能够用于刚性或弹性部件。另外，材料成分能够变化以包括金属、陶瓷和不同于聚合物的其他材料。其他特征部能够应用到图14至图19的实施例，包括光滑的衬垫、亲水涂层或其他涂层、硅树脂或其他液体或印花。
如图20至图23所示，鞘管3的另一实施例能够包括用于嵌入弹性管状层中的支架结构84。支架84能够包括多个环88，多个环88面向相反的周向方向并且在彼此之间(图21至图23)互相交叉或彼此相邻(图21)，以便能够在穿过支架的植入物5的压力下打开。图20示出在环88中的每个之间的附加的全周式绕组90以获得附加刚度。图21、图22和图23示出当植入物5穿过支架84时管腔在支架84内的逐渐膨胀。支架84能够具有变化的长度并且在所示实施例中用于鞘管3的远端。支架84还能够包括如其他实施例中所示的在其远端上的热熔尖端。
支架84是成形框架，其能够由激光切割管形成或者通过将丝弯曲成框架来形成。类似于C形刚性管，支架84在假体植入物5通过期间导致偏心的轴向负载。环88和/或绕组90的相邻关系提供了优异的推动刚度以抵抗屈曲，同时仍然具有周向/径向膨胀性。因此，鞘管具有特别高的屈曲与膨胀力比率-从而允许良好的铰接并且容易膨胀。支架84还特别适用于保护易损的植入物5，如安装在支架上的人工心脏瓣膜。支架84能够由聚合物涂覆以用于止血密封并且保护假体植入物5的外部结构。
鉴于能够应用所公开的发明的原理的许多可能的实施例，应当认识到，所述实施例仅为本发明的优选示例并且不应被视为限制本发明的范围。更确切地说，本发明的范围由随附权利要求限定。因此，我们要求我们的发明全部落入这些权利要求的范围和精神内。

Claims (13)

1.一种限定中央管腔的鞘管，其包括：
多个纵向区段；
沿所述多个纵向区段延伸并且包括多个纵向延伸的杆的可膨胀内层，以及
围绕所述可膨胀内层并沿多个纵向区段延伸的外管状层，
其中所述鞘管的第一纵向区段包括作为所述外管状层的一部分的互相交叉加强结构，所述互相交叉加强结构围绕所述可膨胀内层并且包括多个环，所述多个环面向交替的周向方向并且在彼此之间互相交叉，
其中所述鞘管的所述第一纵向区段经配置暂时膨胀，以允许植入物通过至少部分地打开所述互相交叉加强结构并且增加所述杆的间隔而通过所述中央管腔。
2.根据权利要求1所述的鞘管，其中所述第一纵向区段包括作为所述外管状层的一部分的最外面的覆盖物，所述最外面的覆盖物经配置伸展以容纳通过的植入物。
3.根据权利要求1所述的鞘管，还包括第二纵向区段，其中所述第二纵向区段包括多个周向间隔开的弧形刚性壁部分，作为所述外管状层的一部分，所述多个刚性壁部分平行于所述可膨胀内层且部分地围绕所述可膨胀内层延伸。
4.根据权利要求3所述的鞘管，其中所述刚性壁部分中的每个刚性壁部分包括弯曲的内表面、弯曲的外表面、在所述弯曲的内表面和所述弯曲的外表面之间延伸的第一直边缘，以及在所述弯曲的内表面和所述弯曲的外表面之间延伸的直的第二边缘，并且其中所选择的刚性壁部分的每个弯曲的外表面比所述所选择的刚性壁部分的对应的弯曲的内表面宽。
5.根据权利要求3所述的鞘管，其中所述第二纵向区段还包括在所述刚性壁部分的纵向延伸边缘之间的多个纵向延伸间隙，并且所述鞘管的所述第二纵向区段经配置通过加宽所述多个纵向延伸间隙而暂时膨胀。
6.根据权利要求1所述的鞘管，其中所述加强结构嵌入在所述外管状层中。
7.根据权利要求1所述的鞘管，其中所述多个环中的每一个包括在环之间互相交叉的面向相反的周向方向的U形材料环。
8.根据权利要求1所述的鞘管，其中所述多个环包括第一环和相邻的第二环，
其中所述互相交叉加强结构包括在所述第一环和所述第二环之间延伸的至少一个全周式绕组。
9.根据权利要求5所述的鞘管，其中所述多个纵向延伸间隙包括限定在所述刚性壁部分的近侧部分中的第一纵向延伸间隙和限定在所述刚性壁部分的远侧部分中的第二纵向延伸间隙，
其中被所述多个纵向延伸间隙占去的所述刚性壁部分的横截面的累加周向量沿着所述刚性壁部分向远侧增加。
10.根据权利要求9所述的鞘管，其中所述第二纵向延伸间隙包括至少两倍于所述第一纵向延伸间隙的第二纵向延伸间隙。
11.根据权利要求10所述的鞘管，其中每个第一纵向延伸间隙的远端延伸到对应的第二纵向延伸间隙的近端。
12.根据权利要求9所述的鞘管，其中至少一个第二纵向延伸间隙能够包括具有向远侧逐渐增加的累加周向大小的至少一部分。
13.根据权利要求1所述的鞘管，其中至少两个刚性壁部分包括第一刚性壁部分、第二刚性壁部分和第三刚性壁部分，每个刚性壁部分沿着第二纵向区段的长度延伸，所述第一刚性壁部分、所述第二刚性壁部分和所述第三刚性壁部分大致平行于彼此定向并且在大致平行于所述鞘管的中心纵向轴线的方向上延伸。
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