CN110520076B - 血管植入物 - Google Patents

血管植入物 Download PDF

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CN110520076B
CN110520076B CN201880024608.4A CN201880024608A CN110520076B CN 110520076 B CN110520076 B CN 110520076B CN 201880024608 A CN201880024608 A CN 201880024608A CN 110520076 B CN110520076 B CN 110520076B
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stent
mesh
mesh structure
forming
scaffolding
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CN110520076A (zh
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M·P·华莱士
H·门多萨
R·赖吉多尔吉德
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Silk Road Medical Inc
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Abstract

一种方法和装置涉及血管支架的使用和构造。支架组件包括网结构，该网结构至少部分地附接到支撑或支架结构。支架结构由一个或多个支柱形成，所述支柱共同形成管状体，该管状体被定尺寸为适配在血管内。网结构由一根或多根细丝或缝线形成，所述细丝或缝线交织或编织以形成联接到支架结构的结构。网结构可至少部分地覆盖支架结构或至少部分地被支架结构覆盖。

Description

血管植入物
相关申请的交叉引用
本申请要求2017年2月21日提交的美国临时申请No.62/461,616的优先权，其公开内容通过引用并入本文。该临时申请通过引用整体并入。
背景技术
用于经腔植入的支架通常由金属支撑件制成，该金属支撑件插入人体的一部分中，例如血管内。支架通常是大致圆柱形的，并且被构造和布置成一旦在体内就位则径向扩张。一些支架包括移植物或网结构，其可用于最小化或消除在愈合阶段由于植入体内的支架而患疝气的风险。
支架组件的网结构会增加支架的总宽度，这可能是不期望的。因此，期望制造一种支架，使得从尺寸的角度来看，网结构和支架结构之间的机械附接是有效的。同样重要的是，网结构适当且牢固地附接到支架的支撑部。
发明内容
本文公开了与血管支架组件的使用和构造相关的方法和装置。支架组件包括网结构，该网结构定位在支架结构上和/或至少部分地附接到支架结构。还公开了用于将网结构牢固地附接到支架结构的装置和方法。支架组件还可包括支架输送系统或与支架输送系统联接，支架输送系统被配置成将支架组件输送到患者的血管中。
在一个方面，公开了一种适于植入血管中的支架组件，包括：由多个互连的支柱形成的内支架结构；由多个互连的支柱形成的外支架结构，所述内支架结构位于所述外支架结构内以在其间形成空间，其中，所述内支架结构和所述外支架结构共同形成支架体，所述支架体被定尺寸和成形为适配在血管内；以及网结构，其至少部分地定位在所述内支架结构和所述外支架结构之间的空间中，使得所述网结构以夹层布置附接到所述内支架结构和所述外支架结构。
在另一方面，公开了一种形成支架组件的方法，包括：由多个互连的支柱形成内支架结构；由多个互连的支柱形成外支架结构；将所述内支架结构定位在所述外支架结构内以在其间形成空间，其中，所述内支架结构和所述外支架结构共同形成支架体，所述支架体被定尺寸和成形为适配在血管内；将网结构至少部分地定位在所述内支架结构和所述外支架结构之间的空间中；将所述网结构夹在所述内支架结构和所述外支架结构之间的空间中，以将所述网结构附接到所述内支架结构和所述外支架结构。
其他特征和优点应通过以下对各实施例的描述而显而易见，这些实施例通过示例的方式示出了本公开的原理。
附图说明
图1示出了示例性支架组件。
图2示出了用于将网结构附接到支架结构的卷边结构的示意图。
图3示出了其中可熔聚合物引线附接到镍钛(NiTi)网结构的示例。
图4示出了支架组件的示意图，该支架组件包括两个支架结构，该支架结构包括内支架结构和外支架结构，内支架结构和外支架结构在它们之间形成空间，网结构可定位和附接在该空间中。
图5示出了其中单独的夹持器元件附接到支架结构的实施例。
图6示出了通过网结构的末端手工缝制的细丝的示例。
图7示出了具有闭环锚钉和开环锚钉的支架结构的冠状区域的放大视图。
图8示出了可位于支架结构的冠状部上的锚钉的实施例。
图9示出了具有泪滴形孔的示例性支架组件。
具体实施方式
本文公开了与血管支架的使用和构造相关的方法和装置。支架组件包括网结构，该网结构定位在支撑结构或支架结构上和/或至少部分地附接到支撑结构或支架结构。支架结构由一个或多个支柱形成，所述支柱共同形成管状体，该管状体被定尺寸为适配在血管内。网结构由一根或多根细丝或缝线形成，所述细丝或缝线交织或编织以形成联接到根据本文所述的任一种配置的支架结构的结构。网结构可至少部分地覆盖支架结构或至少部分地被支架结构覆盖。
支架组件还可包括支架输送系统或与支架输送系统联接，支架输送系统被配置成将支架组件输送到患者的血管中。示例性支架输送系统包括细长的支架输送导管，其可例如以经皮方式插入血管中。支架组件可安装在支架输送导管上，例如安装在支架输送导管的远侧区域上。然后，支架输送导管可部署到目标部位，并且支架组件可从支架输送导管被释放，使得支架组件部署并保持在血管中的目标位置。
支架组件可用于植入包括颈动脉的任何血管中。支架组件的网结构可用于最小化或消除在支架组件植入患者的愈合阶段(例如在植入的前30天)由于支架而患疝气的风险。
支架组件可以是任何支架，包括自扩张支架，或通过使球囊膨胀可径向扩张的或通过膨胀构件扩张的支架。支架也可由任何期望材料制成，包括金属材料、金属合金(例如镍-钛)或甚至聚合物复合材料。支架可具有任何线或单元设计。其中可部署本发明的支架的血管包括但不限于诸如血管的自然体血管。
本文描述了用于联接到支架结构的网配置的各种示例。网配置可包括例如(1)网的材料；(2)网的螺纹配置；(3)形成网的细丝的尺寸和数量；(4)网和支架等之间的附接方式；及其组合。本文还描述了用于附接到网结构的支架结构的各种实施例。
图1示出了支架组件100的透视图，支架组件100包括联接到网体110(或网结构)的支架体105(或支架结构)。支架体由多个互连的支柱或线形成，所述支柱或线附接于彼此以形成多个单元或开口。支柱可以多种方式中的任何一种附接于彼此。支架体大致形成圆柱形状，该圆柱形状被定尺寸和成形为适配在血管内，例如颈动脉内。
在一个实施例中，网结构(有时称为“编织物”)由形状记忆合金制成，例如镍钛(NiTi或镍钛诺)。在一个示例性实施例中，网结构由位于支架上的0.0005英寸的镍钛诺细丝形成。在另一个示例性实施例中，网结构由聚酯单丝或复丝形成。
具有聚对苯二甲酸乙二醇酯(“PET”)网结构的支架可向下压接到支架结构上，以便加载到输送系统上。网结构具有的壁厚不会增加或显著地增加整个支架组件的总厚度。在这方面，网结构可被定尺寸为使其壁厚小于支架结构的壁厚的两倍。
现在描述用于将网结构附接到支架结构的各种结构和方法。
通过胶合剂附接
在用于将网结构110附接到支架结构105的实施例中，形成卷边并将卷边用作网结构110和支架结构105之间的机械界面。例如，用于形成网结构的材料的平面部分自翻转以形成这样的卷边。卷边限定一空间，支架结构105的相应部分可插入并固定在该空间中。图2示出了卷边结构205的示意图，卷边结构205附接到网结构110和支架结构105。
单独的卷边结构205例如通过缝制或胶合附接到网结构110。然后，网结构110通过多种方法中的任何一种胶合到支架结构105。例如，网结构可诸如通过将NiTi网结构金焊接到支架结构而焊接到支架结构。备选地，可使用聚合物胶合剂、熔体、溶剂聚合物键合等或保形聚合物涂层。图3示出了其中一些示例，其中，可熔聚合物引线305附接到NiTi网结构110。然后，使网结构的附着聚合物部分熔化、粘合或以其他方式机械附接到支架结构。
以这种方式，支架组件包括从形状记忆材料(例如，镍钛诺)到支架组件的端部处的聚合物材料的过渡。
通过夹层机械附接
在用于将网结构110附接到支架结构105的另一实施例中，网结构110夹在内支架结构105a和外支架结构105b之间。也就是说，支架组件包括两个支架结构，包括内支架结构105a和外支架结构105b，如图4示意性所示。支架结构105a和105b之间形成一空间，网结构110可至少部分地定位在该空间中。以这种方式，网结构110插入或夹在支架结构105a和105b之间，以在它们之间形成牢固的附接。
在一个示例中，以下规格可用于内支架结构和外支架结构：
·NiTi网结构上的0.003"外支架结构和0.006"内支架结构；
·NiTi网结构上的0.002"外支架结构和0.008"或0.009"内支架结构。
如图5所示，在另一夹层实施例中，仅在支架结构的冠状端部上添加单独的夹持器元件505。网结构未在图5中示出。
现在进一步描述夹层实施例。内支架结构和外支架结构可通过将网结构置于它们之间而包封网结构。内支架结构施加比外支架结构高的径向强度或径向向外力，使得在植入时内支架结构和外支架结构之间的净合力将整个支架组件装置推向血管壁(例如，径向向外)。在长度方面，内支架结构和外支架结构均长于网结构的长度。在一个实施例中，除了两个参数之外，内支架结构和外支架结构均具有相同的规格。第一个参数是支架结构的支柱的支柱长度(SL)。第二个参数是支架结构的壁厚(wt)。
在一个示例中，内支架结构的SL短约15％并且外支架结构的SL长约15％。也就是说，内支架结构的所有支柱长度均小于外支架结构的最短支柱。内支架结构与外支架结构之间的SL的净差为30％。通过具有较短的SL，径向强度变得较高。通过具有较长的SL，径向强度变得较低。因此，整个支架组件装置的径向强度向外(即，朝向血管壁)施加其径向强度。
内支架结构的wt为0.006"，外支架结构的wt为0.003"。通过具有较薄的wt，径向强度变得较低。通过具有较厚的wt，径向强度变得较高。因此，复合装置的径向强度向外(例如，朝向血管壁方向)施加其径向强度。此外，复合装置的净wt等于或低于0.009"阈值wt。通过分别调整内支架和外支架的wt和SL以适应较高或较低的径向强度，复合装置的净径向强度朝向血管壁施加向外力。
通过机器缝制附接
如上所述，可在网结构上形成卷边。网可使用缝纫机形成，并且卷边附接到支架结构。网结构也可直接机械地缝制到支架结构的支柱上。根据这种工艺，细丝用于形成将网结构附接到支架结构的线迹式样。缝纫线迹式样可由任何种类的细丝形成，包括例如205手工线迹和301锁式线迹。线迹可沿着支架的支柱(或恰好横跨支架的支柱)以圆周方向形成。线迹宽度可以是恒定的，或围绕装置的圆周变化。
线迹可具有恒定或可变的线迹长度。例如，线迹可沿着支架结构在一定数量的离散位置处更紧密并且在其余位置处略不紧密。编织结构还可形成多种形状和尺寸的孔。
通过手工缝制附接
在另一实施例中，通过将网结构的末端手工缝制到其自身和/或支架，将网结构附接到支架结构。优选的缝制式样可与支架上的定制特征一起使用，以使得更容易将缝线附接到支架上。示例性缝制式样包括测试用301锁式线迹和205手工线迹。
图6示出了通过网结构110的末端手工缝制的细丝605的示例。然后，使用单独的多圈缝线将网结构附接到支架结构的冠状部。将细丝缝制为使其进出所述多个圈。圈的数量可变化。在一个实施例中，存在10到100个圈。
在一个实施例中，细丝(例如，PET细丝)通过NiTi网结构的末端缝制并连接到支架结构。细丝通过网结构的一个或多个圈并且还通过沿支架结构的冠状部的环形孔或开口缝制。
利用缝线锚钉通过手工缝制附接
支架组件的冠状区域可包括一种或多种类型的缝线锚钉。支架的冠状部包括具有“拼合O”构型的第一类型的缝线锚钉，其中，缝线锚钉形成沿其圆周具有间隙或开口的部分环。间隙或开口为缝线插入锚钉提供了通道。
第二类型的缝线锚钉是“实心圆形”或闭合的环，其中，缝线锚钉形成完全闭合的环。图7示出了具有闭环锚钉705和开环锚钉710的支架结构的冠状区域的放大视图。缝线可穿过开环锚钉并以夹板方式固定，其中，缝线也延伸穿过开环锚钉。缝线可交替地围绕闭环锚钉形成环形并且还缠绕在锚钉的基部以进一步将缝线固定到其上。
理想地，网结构以如下的方式固定到支架结构：克服沿着支架结构的纵向轴线在远侧方向和近侧方向上施加的力，将网结构固定到支架结构。也就是说，无论支架结构和网结构之间的相对力的方向如何，网结构都将保持固定并且不会从支架结构脱离。
图8示出了可位于支架结构的冠状部上的锚钉805的实施例。该锚钉形成闭环并且包括一个或多个“耳部”、尖头、倒钩或突起810，其用作进一步将缝线固定到锚钉的结构。如图8所示，缝线805可穿过闭环并且还缠绕在耳部上以将缝线固定到其上并防止其在从输送系统加载和/或移除支架组件期间从支架结构脱离。应当理解，耳部结构仅是示例，并且可使用其他结构进一步将缝线固定到支架结构。
通过互连特征机械附接
在另一实施例中，网与支架的特征机械地互连。可使用多种方法将网结构机械地附接到支架结构。例如，网结构的末端可环绕在支架结构的端部上，或者网结构在其自身内部形成环形，其中，两个编织层位于支架的外侧上。然后，可将两个编织层与该构造粘合或缝制在一起。
可选地，可对编织物的末端进行“收尾”，使得用于编织的细丝不会松开或解开。利用本公开中描述的任何方法来固定编织物的末端。接下来，使网结构的末端环绕在支架的一些特征上。这些特征可包括支架的冠状部或指状突起结构。突起可背离或朝外，以帮助网结构更容易地接合。
通过聚合物涂层附接
在另一实施例中，聚合物涂层可用于对网结构的末端进行收尾和/或将网结构附接到支架结构。在网结构的末端添加薄的聚合物层，以防止网结构在附接到支架结构之前散开。
备选地，聚合物涂层用于帮助对网结构的末端进行“收尾”，并且还用作一次性附接网支架支柱的机构。对于该示例，聚合物可仅喷涂在支架组件的端部上，从而使支架/网结构的中心不含任何聚合物。聚合物涂层可施加于一排或多排编织元件、少于一排编织元件、一个或多个支柱横档元件、或少于一个支柱横档元件。为了仅涂覆编织物的末端，可能需要用掩蔽剂掩蔽支架结构的中心，该掩蔽剂可在涂覆过程完成后除去。
聚合物涂层可利用具有各种固体含量的浸渍或喷涂过程实现。可能需要多个循环来获得足够的涂层。关键是利用涂层将整个编织细丝-支架支柱元件包封，以确保其充分附着。
用于固定网末端和/或粘合到支架的各种聚合物胶合或涂覆可选方案在下表中示出。
Figure BDA0002229470690000081
Figure BDA0002229470690000091
可使用的其他材料包括例如：
派瑞林C：通过气相沉积形成的保形涂层。随着医疗装置的悠久历史。
PEVA：橡胶状共聚物。有多种醋酸乙烯酯系列可供选择。非常低的VA含量(低于10％)难以溶解。较高的VA(18-33％)将是非常柔韧且粘性的。
PBMA：坚韧的材料。不如PEVA柔韧。易溶于多种溶剂。
SIBS：韧性的橡胶材料。可溶于几种溶剂中。
PC：倾向于形成自组装单层。
PVP：水溶性聚合物。
聚偏二氟乙烯/六氟丙烯：可熔融加工。
通过焊接附接
在另一实施例中，网结构也可焊接到支架结构。例如，在焊接过程中可使用以下材料：
-用于Niti支架焊接的Niti线(来自编织物)：激光焊接、电阻焊接
-用于Niti支架焊接的聚合物细丝(来自编织物)
可使用多种网构造。可使用圆形编织方法，其中，孔径可由多种聚合物或金属纤维中的任何一种或其组合形成。示例性NiTi或PET纤维是约0.001"、0.00075"、0.0005"直径的线。
用于网或支架结构的示例性单元式样
在图9所示的实施例中，编织物或网结构可形成和/或被后处理以形成配对的孔或单元式样。例如，网结构形成多个泪滴形孔905，其在第一端具有扩大的圆形区域并且在第二端具有较小的尖角区域。在配对式样中，至少两个泪滴形孔的扩大的圆形区域彼此接触或邻接。泪滴形孔可沿长轴线延伸，其中孔的圆形区域沿轴线定位在第一端，而尖角区域沿轴线定位在第二端，其中，轴线是直的。孔可成排布置，使得两个孔的较大区域在“配对”布置中直接接触，而两个孔的较小区域彼此间隔开。一系列孔(例如，孔905a和905b)沿共同的长轴线同轴。可实现该式样的一种方式是编织具有单独的多个孔的管状编织结构，其中，至少一些孔为大致圆形、正方形或矩形形状。管状编织物可纵向拉伸到较小直径的心轴上，以产生呈现配对或泪滴形式样的细长孔；然后，可选地对该结构进行热定形以保持该形状。
上述泪滴形孔布置能够利用特定线来实现较小的孔径以形成支架组件和孔，例如直径在0.0005"至0.001"范围内的镍钛诺线。在一个示例性实施例中，“配对”孔构造能够实现100-250um的最小孔宽度和范围从3:1至10:1的长宽比。
虽然本说明书包含许多细节，但这些细节不应被解释为对要求保护的或可要求保护的发明的范围的限制，而是作为对特定实施例特有的特征的描述。在本说明书中单独实施例的上下文中描述的某些特征也可在单个实施例中组合实现。相反，在单个实施例的上下文中描述的各种特征也可在多个实施例中单独地或以任何合适的子组合实现。此外，尽管上述特征可被描述为以某些组合起作用甚至最初是如此主张的，但在某些情况下可从组合中删除所要求保护的组合中的一个或多个特征，并且所要求保护的组合可以涉及子组合或子组合的变型。类似地，虽然在附图中以特定顺序图示了操作，但这不应被理解为要求以所示的特定顺序或按顺序执行这些操作，或者执行所有示出的操作，以实现期望的结果。仅公开了几个示例和实施方式。可基于所公开的内容对所描述的示例和实施方式以及其他实施方式进行变型、改进和增强。

Claims (7)

1.一种形成支架组件的方法，包括：
由多个互连的支柱形成支架结构，所述支架结构包括内支架结构和外支架结构；
将所述内支架结构定位在所述外支架结构内以在其间形成空间，其中，所述内支架结构和所述外支架结构共同形成支架体，所述支架体的尺寸和形状被设置为适配在血管内；
形成具有多个孔的管状编织结构，其中，所述孔中的至少一些是圆形、正方形或矩形形状；
将所述管状编织结构纵向拉伸到心轴上，以使所述孔中的至少一些形成泪滴形孔；
对所述管状编织结构进行热定形以形成网结构；
将所述网结构至少部分地定位在所述内支架结构和所述外支架结构之间的空间中；
将所述网结构夹在所述内支架结构和所述外支架结构之间的空间中，以将所述网结构附接到所述内支架结构和所述外支架结构，
其中，所述支架结构的冠状区域包括开环锚钉和闭环锚钉，其中，缝线穿过所述开环锚钉并以夹板方式固定，并且所述缝线进一步交替地围绕所述闭环锚钉形成环形并缠绕在所述闭环锚钉的基部上。
2.根据权利要求1所述的方法，还包括在所述网结构上形成卷边。
3.根据权利要求2所述的方法，还包括将所述内支架结构和所述外支架结构中的一个的至少一部分定位在所述卷边内。
4.根据权利要求2所述的方法，其中，在所述网结构上形成卷边包括将卷边附接到所述网结构。
5.根据权利要求2所述的方法，其中，在所述网结构上形成卷边包括将所述网结构的一部分折叠在其自身上。
6.根据权利要求1所述的方法，还包括在所述网结构中形成多个泪滴形孔。
7.根据权利要求1所述的方法，其中，所述泪滴形孔被布置成使得至少两个泪滴形孔在第一端具有扩大的圆形区域而在第二端具有较小的区域，并且其中，至少两个泪滴形孔的扩大的圆形区域彼此接触。
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