CN103767810A - 自伸展支架的成形方法 - Google Patents

自伸展支架的成形方法 Download PDF

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CN103767810A
CN103767810A CN201310576495.8A CN201310576495A CN103767810A CN 103767810 A CN103767810 A CN 103767810A CN 201310576495 A CN201310576495 A CN 201310576495A CN 103767810 A CN103767810 A CN 103767810A
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filament
joint design
joint
anchor portion
filament part
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CN103767810B (zh
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J·谢尔登
R·布思
K·比克
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IDEV Technologies Inc
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IDEV Technologies Inc
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Abstract

本发明公开一种自伸展支架的成形方法，该方法包括：通过在多根线丝中的每一根形成第一弯曲转向部分，以形成所述支架的第一端，每根线丝均包括位于所述第一弯曲转向部分两侧的线丝部分，每个线丝部分包括线丝部分端部：平纹编织所述线丝部分，在平纹编织所述线丝部分后，每个所述线丝部分的端部编织到邻近所述支架的第一端；在平纹编织所述线丝部分后，在第一温度下对多根所述线丝加热处理第一加热处理时间；通过在多根线丝中的每一根形成第二弯曲转向部分，以形成所述支架的第二端部；并且在形成所述第二弯曲转向部后，在第二温度下对多根所述线丝加热处理第二加热处理时间。

Description

自伸展支架的成形方法
本申请是申请号为200780046684.7、申请日为2007年10月22日、发明名称为“用于固定线丝端的方法以及由该方法形成的装置”的专利申请的分案申请。
技术领域
本发明主要涉及用于固定适于放置到解剖结构内的装置的线丝（例如金属丝）端的方法和结构，以及由该方法和结构所形成的装置。这种装置的例子包括编织而成的、自伸展的支架（stent）。
背景技术
在专利号为6,007,574、6,419,694和7,018,401的美国专利以及公布号为US2005/0049682和US2006/0116752的美国专利申请中，公开了由一根或多根线丝所形成的、适于插入到解剖结构内的装置的多个例子，该多个例子通过引用合并于此。
发明内容
本发明方法的一些实施方式包括以下步骤：将接头结构固定到成形为适于插入解剖结构中的装置的第一线丝端部上；以及将所述接头结构固定到所述装置的第二线丝端部上；其中，所述第一线丝端部和所述第二线丝端部基本对准，所述接头结构不是所述装置的线丝，并且所述装置包括一根或多根包含有镍和钛的线丝。在一些实施方式中，所述接头结构的长度小于所述装置长度的25%、24%、23%、22%、21%、20%、19%、18%、17%、16%、15%、14%、13%、12%、11%、10%、9%、8%、7%、6%、5%、4%、3%、2%、1%、0.9%、0.8%、0.7%、0.6%、0.5%、0.4%、0.3%、0.2%或0.1%；这可以适用于所使用的每个接头结构。所述接头结构可以成形为在其被固定到所述第一线丝端部和所述第二线丝端部之前具有通道，并且在进行固定之前该接头结构可以设置为与所述第一线丝端部和所述第二线丝端部直接接触。所述装置可以是支架（例如，由多根线丝编织而成的支架），或者适于在治疗患者时使用的其它任何医疗装置，例如过滤器或封堵器（occluder）。所述装置可以自伸展。所述装置可以具有两个或多个装置端（例如直支架的两个端或分叉支架的三个端），并且每个装置端可以以线丝弯曲转向部分（strand bends）为特征或者可以由线丝弯曲转向部分来限定，其中，特定装置端的线丝弯曲转向部分至少相互之间在形状上是相似（例如，基本相似）的，而在一些情形下则与所有装置端的所有线丝弯曲转向部分在形状上相似，从而使得一个装置端与另一个装置端或另一些装置端外表非常相似。所使用的接头结构的数量可以与用来形成所述装置的线丝（例如，金属丝）的数量对应，并且这些接头结构可以定位为轴向排列成行（平行于所述装置的纵向轴线），或者可以相对于彼此轴向偏移并环绕所述装置的外周定位。所述固定可以通过将所述接头结构焊接（例如，激光焊接）到所述第一线丝端部以形成第一焊接区以及将所述接头结构焊接到所述第二线丝端部以形成第二焊接区来实现。该两个焊接区可以彼此分离，而不通过其它任何焊接区连接。在一些实施方式中所述两个线丝端部相互之间直接接触，而在其它实施方式中，所述两个线丝端部相互之间并不直接接触。所述线丝端部可以基本相互对准（端对端），或者可以定位为并排关系（该并排关系的特征可以是搭接）。在一些实施方式中，所述接头结构是与所述第一线丝端部和所述第二线丝端部分离的一块材料，当采用焊接来进行固定时，在焊接开始前，该接头结构设置为与所述两个线丝端部均直接接触。在一些实施方式中，所述固定步骤中的一些或全部步骤导致特定线丝的特定一半固定到（a）仅一根其它的线丝上或（b）仅同一根线丝的另一半上。在一些实施方式中，所述接头结构定位在与该接头结构交叉的线丝的下方。在一些实施方式中，所使用的全部接头结构均以该相同的方式定位。在一些实施方式中，接头结构和固定到该接头结构的线丝端部在所述固定完成后均不经过精加工（smoothing）步骤。在一些实施方式中，所述装置由多根线丝编织而成，从而产生限定钝角的线丝交叉点，当所述装置在非约束状态下被轴向压缩时，线丝交叉点所限定的钝角会增大，每个装置开口（不包括那些接近所述装置的纵向通道或通道的开口）由至少三个线丝交叉点限定，其中每个线丝交叉点由两个交叉的线丝部分限定。在一些实施方式中，最靠近所述装置的特定端（“装置端”）定位的所述接头结构通过至少一个线丝交叉点（在一些实施方式中，通过至少两个线丝交叉点；在一些实施方式中，通过至少三个线丝交叉点；在一些实施方式中，通过至少四个线丝交叉点；在一些实施方式中，通过至少五个线丝交叉点）在与所述装置的纵向轴线基本平行的方向上（例如，沿一条线）与所有的装置端均间隔开（即使在最靠近所述装置端的接头结构的部分上也是如此）。
本方法的一些实施方式包括以下步骤：将接头结构焊接到成形为适于插入解剖结构中的装置的第一线丝端部上；以及将所述接头结构焊接到所述装置的第二线丝端部上；其中，所述接头结构不是所述装置的线丝，并且所述装置包括一根或多根包含有镍和钛的线丝。
本装置可以具有一根或多根线丝，并成形为适于插入解剖结构中。在一些实施方式中，本装置包括固定到基本相互对准的两个不同的线丝端部上的接头结构；其中所述两个不同的线丝端部包含有镍和钛，并且所述接头结构不是所述装置的线丝。在一些实施方式中，本装置包括焊接到两个不同的线丝端部上的接头结构；其中所述两个不同的线丝端部包含有镍和钛，并且所述接头结构不是所述装置的线丝。所述装置可以是支架，或适于在治疗患者时使用的其它任何医疗装置，例如过滤器或封堵器。所使用的接头结构的数量可以与所述装置所具有的线丝（例如，金属丝）的数量相对应，并且所述接头结构可以定位为轴向排列成行（平行于所述编织装置的纵向轴线），或者所述接头结构可以相对于彼此轴向偏移并环绕所述装置的外周定位。固定于（例如，焊接于）特定接头结构的每对线丝端部可以基本相互对准，或者可以相互布置为并排关系（该并排关系的特征可以是搭接）。在一些实施方式中，所述接头结构的长度小于所述装置长度的25%、24%、23%、22%、21%、20%、19%、18%、17%、16%、15%、14%、13%、12%、11%、10%、9%、8%、7%、6%、5%、4%、3%、2%、1%、0.9%、0.8%、0.7%、0.6%、0.5%、0.4%、0.3%、0.2%或0.1%；这可以适用于所使用的每个接头结构。所述接头结构可以成形为在其被固定到所述第一线丝端部和所述第二线丝端部之前具有通道，并且在进行固定（例如，焊接）之前该接头结构可以设置为与所述第一线丝端部和所述第二线丝端部直接接触。所述装置可以是支架（例如，由多根线丝编织而成的支架），或适于在治疗患者时所使用的其它任何医疗装置，例如过滤器或封堵器。所述装置可以自伸展。所述装置可以具有两个或多个装置端（例如直支架的两个端或分叉支架的三个端），并且每个装置端可以以线丝弯曲转向部分为特征或者可以由线丝弯曲转向部分限定，其中特定装置端的线丝弯曲转向部分至少相互之间在形状上是相似（例如，基本相似）的，而在一些情形下则与所有装置端的所有线丝弯曲转向部分在形状上相似，从而使得一个装置端与另一个装置端或另一些装置端外表上非常相似。所使用的接头结构的数量可以与用于形成所述装置的线丝（例如，金属丝）的数量相对应，并且所述接头结构可以定位为轴向排列成行（平行于所述装置的纵向轴线），或者所述接头结构可以相对于彼此轴向偏移并环绕所述装置的外周进行定位。所述接头结构可以通过形成第一焊接区的焊接固定到所述第一线丝端部，并通过形成第二焊接区的焊接固定到所述第二线丝端部上，并且该第一焊接区和第二焊接区不通过另一个焊接区相互直接连接。该两个焊接区可以彼此分离而不通过任何其它焊接区进行连接。在一些实施方式中所述两个线丝端部相互直接接触，而在其它实施方式中，所述两个线丝端部不相互直接接触。在一些实施方式中，所述接头结构是与所述第一线丝端部和所述第二线丝端部分离的一块材料，当采用焊接来将所述接头结构固定到所述线丝端部上时，在焊接开始前，该接头结构设置为与所述两个线丝端部均直接接触。在一些实施方式中，所述装置的特定线丝的特定一半固定到（a）仅一根其它的线丝上或（b）仅同一根线丝的另一半上。在一些实施方式中，所述接头结构定位在与该接头结构交叉的线丝的下方。在一些实施方式中，所使用的全部接头结构均以该相同的方式定位。在一些实施方式中，所述接头结构和固定到该接头结构的线丝端部在固定后均不需要精加工。在一些实施方式中，所述装置由多根线丝编织而成，从而产生限定钝角的线丝交叉点，当所述装置在非约束状态下被轴向压缩时，线丝交叉点所限定的钝角会增大，每个装置开口（不包括那些接近所述装置的纵向通道或通道的开口）由至少三个线丝交叉点限定，其中每个线丝交叉点由两个交叉的线丝部分限定。在一些实施方式中，最靠近所述装置的特定端（“装置端”）定位的所述接头结构通过至少一个线丝交叉点（在一些实施方式中，通过至少两个线丝交叉点；在一些实施方式中，通过至少三个线丝交叉点；在一些实施方式中，通过至少四个线丝交叉点；在一些实施方式中，通过至少五个线丝交叉点）在与所述装置的纵向轴线基本平行的方向上（例如，沿一条线）与所有装置端均间隔开（即使在最靠近所述装置端的接头结构的部分上也是如此）。
本发明的方法和装置中的任一个的任何实施方式可以由或基本由所述步骤和/或特征组成，而不是包含/包括/含有/具有所述步骤和/或特征。
下面说明与这些实施方式和其它实施方式有关的细节。
附图说明
下列附图仅通过实施例的方式进行阐述，而非限制性的。相同的附图标记并不一定表示相同的结构。更确切地说，相同的附图标记可以用来表示相似的特征或具有相似功能的特征。为使得附图清楚，各个实施方式的每个特征并非均在显示该实施方式的每个附图中进行了标示。
图1显示正在进行成形以适于插入解剖结构中的装置的一部分的实施例，并且所述装置正处在自由线丝端位于该装置的一端的形成阶段。在该图的顶部中心部分显示有挂钩，该挂钩正将所述装置保持在下面的表面上。该挂钩并不是所述装置的组成部分。
图2显示正在进行成形以适于插入解剖结构中的装置的一部分的实施例，并且所述装置正处在所述自由线丝端中的一半已经被向后编织，而另一半仍留在所述装置的一端的形成阶段。
图3显示图1所表示的编织和图2所表示的向后编织完成后的装置的一部分的实施例，并且所述装置包括接头结构，该接头结构的数量等于用于形成该装置的线丝的数量。具体而言，一个接头结构已被激光焊接到所述装置的六对不同的基本对准的线丝端部中的每对上（对于总共六个接头结构而言）。
图4A和图4B显示与图3中所显示的装置类似的其他装置的一部分的实施例。
图5显示与图3和图4中所显示的装置类似的装置的装置端（以及限定这些装置端的线丝弯曲转向部分的相似性）的结构。
图6显示具有接头结构的装置的一部分的实施例，其中所述接头结构轴向排列成行，并且各自将处于搭接关系的两个线丝端部固定。
图7显示具有接头结构的装置的一部分的实施例，其中所述接头结构轴向排列成行，并且各自将基本对准的两个线丝端部固定。
图8显示装置的一部分的实施例，该装置除了相邻的接头结构环绕所述装置的外周彼此间隔开之外，其它部分均与图6中所显示的装置类似。其中，对所述接头结构中的距离观察者最远的两个接头结构进行了标示。
图9显示装置的一部分的实施例，该装置除了相邻的接头结构环绕所述装置的外周彼此间隔开之外，其它部分均与图7中所显示的装置类似。
图10A显示固定到基本对准的两个线丝端部上的一个接头结构。
图10B显示固定到相互搭接的两个线丝端部上的一个接头结构。
图10C显示固定到基本对准的两个线丝端部上的接头结构的另一实施方式。
图11A和图11B是示意图，该示意图显示用于装置（如编织支架）的接头结构的不同布置方式的实施例。
图12显示激光焊接系统的实施例，该激光焊接系统能够用于形成图2至图9所示的装置。
图13是表格，该表格提供了能够用于特定尺寸的六线丝编织支架的特定直径的镍钛金属丝尺寸的镍钛接头结构的内径、外径以及长度尺寸的实施例，此外还提供了用于下述的LASAG焊接系统的设置参数的实施例（其中scfh表示标准立方英尺/小时）。
图14A是详图，该详图显示了通过将图示的接头结构固定到图示的线丝上的焊接工艺所产生的特定尺寸的焊接区。
图14B是表格，该表格包含图14A中所显示的尺寸的实施例值，以及根据本发明的方法所形成的支架的其它方面的参数。
具体实施方式
术语“包含（comprise）”（以及“包含”的任何形式，例如单数形式的“包含”和现在分词形式的“包含”）、“具有（have）”（以及“具有”的任何形式，例如单数形式的“具有”和现在分词形式的“具有”）、“含有（contain）”（以及“含有”的任何形式，例如单数形式的“含有”和现在分词形式的“含有”）和“包括（include）”（以及“包括”的任何形式，例如单数形式的“包括”和现在分词形式的“包括”）均是开放性的联系动词。因此，“包含”、“具有”、“含有”或“包括”一个或多个部件或步骤的装置或方法具有该一个或多个部件或步骤，但不局限于仅仅具有该一个或多个部件或步骤。同样，“包含”、“具有”、“含有”或“包括”一个或多个特征的装置的部件或方法的步骤具有该一个或多个特征，但并不局限于仅仅具有该一个或多个特征。另外，以某种方式成形的结构应当理解为至少以该方式成形，但也能够以未说明的其它方式成形。
本发明的方法和装置中的任一个的任何实施方式可以由或基本由所述的步骤和/或特征组成，而不是包含/包括/含有/具有所述的步骤和/或特征。因此，作为实施例，尽管本发明方法的一些实施方式包括以下步骤：将接头结构焊接到成形为适于插入解剖结构中的装置的第一线丝端部上；以及将所述接头结构焊接到所述装置的第二线丝端部上；其中所述接头结构不是所述装置的线丝，并且所述装置包括一根或多根包含有镍和钛的线丝，但其它一些实施方式则基本由或由以下步骤组成：将接头结构焊接到成形为适于插入解剖结构中的装置的第一线丝端部上；以及将所述接头结构焊接到所述装置的第二线丝端部上；其中，所述接头结构不是所述装置的线丝，并且所述装置包括一根或多根包含有镍和钛的线丝。
术语“一”（“a”和“an”）限定为一个或多于一个，除非本申请公开内容中明确表示有另外的含义。术语“基本”和“大约”限定为至少接近于（以及包括）特定的值或状态（优选地在特定的值或状态的10%范围内，更优选地在特定的值或状态的1%范围内，最优选地在特定的值或状态的0.1%范围内）。
本发明的方法可以用来固定成形为适于插入解剖结构中的装置的两个未固定的线丝端。用于形成所述装置的初始工艺可以包括编织工艺（例如专利号为6,792,979和7,048,014的美国专利中所公开的编织方法，该两篇美国专利通过引用予以合并），或者能够产生至少两个未固定的线丝端的任何其它类型的工艺。如果采用编织工艺，“Steeger USA”（斯巴达堡，南卡罗莱纳州）生产的“Steeger24Carrier Horizontal Fine Wire Carrier Braider HS140-24-IH”是一种可以使用的合适的编织机。所述装置可以由一根或多根线丝形成，并且该装置可以具有多种结构，例如支架（如，具有两个端的支架或具有两个以上的端的多腿支架）、封堵器或过滤器。所述线丝端可以通过接头结构固定，该接头结构包括通道（例如细管），所述线丝端能够从相对端插入该通道内，并将该通道焊接（例如，激光焊接）到插入到该通道内的线丝端部上。但是，所述接头结构不需要像细管那样包围所述线丝端。替代地，在其它实施方式中，所述接头结构可以包括与所述线丝端连接的平条带或仿形的条带，例如细管的一部分。此外，尽管激光焊接在下文中被描述为优选的连接方法，但是也可以使用其它方法，包括（但不限于）电子束焊接、电阻焊接、钨惰性气体焊接、金属惰性气体焊接、压接（crimping）、热焊接、热膨胀连接（braising）以及粘接。
所述接头结构可以由与连接到所述接头结构的线丝端部采用的材料相同的材料制成（例如，镍-钛接头结构可以用于将两个镍-钛线丝端部连接在一起），或者可以由一种或数种不同的材料制成（例如，不锈钢接头结构可以用于将两个镍-钛线丝端部连接在一起）。
在装置由镍-钛金属丝（镍—占全部组分重量的56.0%；钛—占全部组分的平衡量）编织而成的实施方式中，在初始编织工艺完成后，所述装置（如果需要，可以具有心轴，该装置形成在该心轴上）可以根据下表1中的数据进行热处理：
表1
支架的直径（mm） 加热炉的温度设置（℃） 热处理时间（分钟）
4.0 525 5
5.0 535 5
6.0 510 10
7.0 520 10
8.0 510 13
9.0 520 13
10.0 530 13
当以该方式对装置进行热处理时，所述装置可以具有位于所述装置端中的一些或全部装置端上的自由线丝端。图1显示装置（装置100）的一个实施例，该装置具有一根或多根线丝并且成形为适于插入解剖结构中。装置100为一种支架，该装置100由具有十二根半线丝10的六根线丝（金属丝）按照美国专利No.7,018,401所公开的方法编织而成。在装置100的未显示的装置端上没有自由线丝端。各个半线丝仅固定到（参见图3）另一个半线丝上（该另一个半线丝可以属于相同的线丝或不同的线丝）。
在进行该热处理后，所述装置可以在去离子水中直接进行淬火直至冷却。接下来，所述装置的自由线丝端可以根据需要向后编织，进而再根据表1中的数据进行烘焙处理，并在去离子水中直接进行淬火直至冷却。图2显示松散的十二个线丝端中的一半已经被向后编织后的装置100。
接下来，可以将一个或多个接头结构（例如，含有镍和钛的接头结构，如镍占全部组分重量的55.8%，钛占全部组分的平衡量）沿所述装置的长度方向在任何需要的位置上连接到所述编织的装置的线丝端部上。在定位所述接头结构之前，可以将所述装置装载到心轴上，以能够精确地设置所述装置的内径。一旦所述接头结构已经按照要求定位，则可以采用任何适当的方法，例如激光焊接（将在下文中对激光焊接进行更详细地阐述）将该接头结构固定到线丝端部上。图3至图4B显示装置100的实施例，其中接头结构20已经分别设置为与一对线丝端部接触，并进而按照下述的激光焊接方法焊接到那些线丝端部上。图5显示通过图1至图4B以及图6至图9中所显示的制作所述装置的编织方法、向后编织方法以及接头结构固定方法所形成的一种装置100的两个装置端102，104，并且显示所述装置端102，104（装置端104是最靠近所使用的接头结构的装置端）分别由线丝弯曲转向部分40（并非所有的线丝弯曲转向部分40均进行了标示）限定，其中所述线丝弯曲转向部分40均具有基本相似的形状。
如图3和图4A所示，在一些实施方式中，最靠近特定装置端的接头结构（例如，在这些附图中所显示的最右边的接头结构20）可以通过至少一个线丝交叉点或多个线丝交叉点与所述装置端间隔开。在这些附图中所显示的实施方式中，图示的最右边的接头结构20通过沿着线40所取的至少三个线丝交叉点（该三个线丝交叉点通过标记为30的圆圈指示）与图示的装置端间隔开，该线40与所述装置100的纵向轴线50基本平行。该最右边的接头结构20通过至少一个装置开口45或多个装置开口45与图示的装置端间隔开；具体而言，通过至少三个装置开口45与图示的装置端间隔开（所述装置开口45在图中的其它地方已经被画出轮廓，以显示出这种类型的开口（也可以以网孔开口为特征）由线丝交叉点限定，具体而言，除了最末行的装置开口之外，其它装置开口均由四个线丝交叉点限定，所述最末行的装置开口仅通过三个线丝交叉点来限定（因此，在该图中显示的此种装置100的所有装置开口均由至少三个线丝交叉点限定））。此外，该最右边的接头结构20从图示的装置端沿着线40形成第四个线丝交叉点30，并定位在与该接头结构20交叉的装置100的线丝的下方。其它接头结构20中的每个接头结构20同样各自定位在与该每个接头结构20交叉的装置100的线丝的下方。在固定之前，与特定接头结构固定连接的线丝端可以进行切割（根据需要），以使得所述线丝端基本居中地定位在将要经过该接头结构的线丝的下方；从而，该接头结构的中心将基本位于由该接头结构部分限定的交叉点上，这适用于图3至图4B中所显示的接头结构。
所使用的接头结构（对于支架而言，接头结构的数量优选等于线丝的数量）可以如同图3、图4A、图4B、图6以及图7中所显示的接头结构20那样轴向排列成行，或者可以如同图8和图9中所显示的接头结构20那样轴向彼此间隔开并环绕所述装置的外周进行定位。用于切割线丝端的切割机可以是注册商标为
Figure BDA0000416282290000121
、型号为576TX（硬质合金切割机）或503ETST（斜头硬质合金切割机）的切割机，这些类型的切割机可以从“Cooper Hand Tools（Cooper Industries，LLC）”获得。针对所述装置的微小尺寸，在切割所述线丝端以及布置所述接头结构的过程中可以采用显微镜。
图10A至图10C显示用于接合或连接两个线丝端（该两个线丝端可以是不同的线丝的线丝端或相同的线丝的线丝端）的接头结构的实施例以及通过这些接头结构固定的线丝端部的布置方式的实施例。图10A显示固定于处于对接接头或对接结构形式的线丝端部12，14上的接头结构20；这种布置方式使得线丝端部12，14基本相互对准。通过形成第一焊接区22的焊接将接头结构20固定到线丝端部12上，并通过形成第二焊接区24的焊接将接头结构20固定到线丝端部14上。如图所示，第一焊接区22并未通过另一个焊接区连接到第二焊接区24；该两个焊接区彼此间隔开并分离。此外，尽管在其它实施方式中这两个线丝端部彼此直接接触，但在该图中显示的这两个线丝端部彼此并不直接接触（在它们的末端之间具有微小的间隙）。在图10A中显示的这种接头结构20具有在将接头结构固定到所述两个线丝端部中的任意一个之前存在的通道，并且该通道的尺寸适于容纳装置的一根线丝。
图10B显示固定到处于搭接接头或搭接结构形式的线丝端部12，14上的接头结构20；该结构也可以以搭接为特征。因此，所述两个线丝端部定位在彼此的侧面而不是端对端。尽管在该实施方式中所述两个线丝端部之间显示有微小的间隙，但在其它实施方式中，它们之间可以侧面对侧面地直接接触。所述两个焊接区22，24具有与图10A的实施方式中的焊接区相同的特征：即该两个焊接区22，24不通过另一焊接区彼此连接；它们彼此间隔开并分离。尽管在图10B中示意性显示的形成两个焊接区的两次焊接各自仅指向一个线丝端部，但该两次焊接也可以各自应用于两个线丝端部，正如形成如图6中所显示的焊接区的焊接那样。在图10B中显示的该种接头结构20具有通道，该通道在将所述接头结构固定到所述两个线丝端部中的任意一个之前存在，并且所述通道的尺寸适于容纳装置的两根线丝。
图10C显示本发明接头结构中的一个接头结构的另一实施方式，即接头结构20’，该接头结构20’通过形成第一焊接区22和第二焊接区24的两次焊接固定于第一线丝端部12和第二线丝端部14。接头结构20’不具有通道；替代地，该接头结构20’成形为管状结构的一部分（例如，具有弧的条带，尽管在其它实施方式中该条带是扁平的）。
图11A是显示用于特定装置的接头结构20轴向排列成行的示意图。图11B显示接头结构20可以成螺旋形地布置，这是一种将这些接头结构20相对于彼此轴向地和圆周地（例如以60°的间隔）进行偏移的方法。
对于由镍钛金属丝（例如含有占全部组分重量的56.0%的镍和占全部组分平衡量的钛的金属丝）制成的编织支架而言，由同种类型的镍钛合金（例如含有占全部组分重量的55.8%的镍和占全部组分平衡量的钛的镍钛合金）制成的接头结构可以用于通过激光焊接（例如脉冲激光焊接）的方式连接不同的线丝的端部。图12中显示了一种合适的激光焊接系统的实施例，该激光焊接系统包括LASAG脉冲Nd：YAG（钕：钇铝石榴石）“EasyWelder”激光系统，该激光系统选自SLS200系列（Lasag，瑞士）。
对于由六根镍钛金属丝（镍—占全部组分重量的56.0%；钛—占全部组分的平衡量）制成的支架而言，可以使用六个镍钛接头结构（镍—占全部组分重量的55.8%；钛—占全部组分的平衡量）。图13中的表格提供了能够用于特定尺寸的六线丝编织支架的特定直径的镍钛金属丝尺寸的镍钛接头结构的内径、外径和长度尺寸的实施例，并且还提供了上述LASAG焊接系统的设置参数的实施例（scfh表示标准立方英尺/小时）。
下面简要地说明如何通过使用上述LASAG焊接系统的至少半自动化（在其它实施方式中可以为全自动化）的工艺，将所述接头结构固定到经过热处理的（根据上述方法进行热处理）、由六根金属丝编织而成的镍钛支架的成对的金属丝端部上：
所述支架已经被部分地向后编织（例如，手工编织），这意味着12个金属丝端中的6个金属丝端已经被向后编织到所述支架中；
从任何适当的金属丝交叉点（例如，从已经被向后编织的金属丝端开始的第四个或第五个金属丝交叉点）开始，如上所述切割所述金属丝端，以使得所述金属丝的末端在交叉的金属丝下方接触；
所述接头结构装载到所述金属丝端上，并关于所述交叉金属丝居中定位，同时将所述支架装载在心轴上，以能够精确地设置所述支架的内径；
将所述支架的连接区通过弹簧加载式夹子固定到所述心轴上，以防止所述支架和心轴之间的相对运动，并且能够精确地设置所述支架的内径以及在所述接头结构内保持所述金属丝端部的正确布置；
进而，将安装并固定有支架的所述心轴放置在激光焊接系统中，并且在系统的观察屏上将第一接头结构与水平十字准线对准；
调用用于特定尺寸的待焊接支架的焊接程序（下文提供有实施例）；以及
提示操作员将所述十字准线与所述接头的左上角对准。一旦对准，操作员按下开始按钮，从而形成左焊缝。然后所述系统移动，并提示操作员将所述十字准线对准到接头的右上角。一旦对准，操作员按下开始按钮，从而形成右焊缝。然后，所述系统移动到第二接头的左上角并重复所述过程。这将持续到全部12次焊接完成。
图14A中显示了本发明装置（具体地，例如图1至图4B中所显示的那些编织支架）中的一个装置的特定接头结构20的焊接区24的尺寸，并在图14B中给出了这些尺寸的实施例值。下表2提供了与图14B中给出的“接头结构编号”相对应的管状接头结构尺寸的实施例值：
表2
接头结构编号 接头结构内径（英寸）接头结构外径（英寸）接头结构长度（英寸）
-01 0.00700.01000.070
-02 0.00700.01000.080
-03 0.00750.01050.100
-04 0.00850.01200.120
-05 0.00850.01200.150
除非另有规定，图14B中的值的公差如下：X.=±1；.X=±.5；.XX=±.25；.XXX=±.125。除非另有规定，表2中的值的公差如下：.X=±.030；.XX=±.010；.XXX=±.005。
因此，以图14B的第一行为例，由直径为0.006英寸的镍钛金属丝（例如上述的金属丝）制成的内径为4.0mm、长度为40mm的特定支架，可以由内径为0.0070英寸、外径为0.0100英寸以及长度为0.070英寸的各个管状接头结构（编号-01）制作，通过将该接头结构固定到指定的金属丝中的一个金属丝上的激光焊接所产生的焊接区的尺寸A、B、C分别为A=0.010英寸、B=0.005英寸以及C=0.010英寸。
下列以工业标准NC（数字代码）编写的例行程序能够用来作为上述LASAG焊接系统的程序，该LASAG焊接系统用于通过使用上述接头结构来形成对接式接头，从而得到在各个例行程序前列明的各种尺寸的镍钛支架（通过使用上述的镍钛合金形成）：
4mm内径的支架
;4mm内径支架的焊接程序
M61;激光远程控制
;焊接参数
C101Q10;频率10HZ
C102Q0.25;脉冲宽度0.25ms
C108Q200;峰值功率200W
C111Q120;A标度值120
M51;激光监控正常
;将激光移动到通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
Z-2.656;调节焦点
;焊接六个接头
M26H152;机门复位
M98P2;转到子程序1–第一接头
F4;快速进给以进行内部（inter）移动
X-.040Y.037;退回相对原点
M98P2;转到子程序1–第二接头
F4;快速进给以进行内部移动
X-.040Y.037;退回相对原点
M98P2;转到子程序1–第三接头
F4;快速进给以进行内部移动
X-.040Y.037;退回相对原点
M98P2;转到子程序1–第四接头
F4;快速进给以进行内部移动
X-.040Y.037;退回相对原点
M98P2;转到子程序1–第五接头
F4;快速进给以进行内部移动
X-.040Y.037;退回相对原点
M98P2;转到子程序1–第六接头
;返回通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
M25H152;打开机门
M02;数字代码结束
;/*程序结束*/
;接头焊接子程序
O2;焊接程序
Fl;进给率
G05Q1;间歇地缓慢移动/移动到左上角
G91;增量坐标
M8;开气
G4F.5;停留0.5秒
X0.008Y-.004;从接头的角偏移
M71;激光加工并同步进给
X0.015;焊接左焊缝=0.015
M70;停止激光加工
X0.058Y.0045;指向右上角
G05Q1;间歇地缓慢移动/调节到右上角
X-0.008Y-.004;从接头的右上角偏移
M71;激光加工并同步进给
X-0.015;焊接焊缝=0.015
M70;停止激光加工
M9;关气
M99;返回
5mm内径的支架
;5mm内径支架的焊接程序
M61;激光远程控制
;焊接参数
C101Q10;频率10HZ
C102Q0.25;脉冲宽度0.25ms
C108Q200;峰值功率200W
C111Q120;A标度值120
M51;激光监控正常
;移动到通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
Z-2.656;调节焦点
;焊接六个接头
M26H152;机门复位
M98P2;转到子程序1–第一接头
F4;快速进给以进行内部移动
X-.040Y.041;退回相对原点
M98P2;转到子程序1–第二接头
F4;快速进给以进行内部移动
X-.040Y.041;退回相对原点
M98P2;转到子程序1–第三接头
F4;快速进给以进行内部移动
X-.040Y.041;退回相对原点
M98P2;转到子程序1–第四接头
F4;快速进给以进行内部移动
X-.040Y.041;退回相对原点
M98P2;转到子程序1–第五接头
F4;快速进给以进行内部移动
X-.040Y.041;退回相对原点
M98P2;转到子程序1–第六接头
;返回通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
M25H152;打开机门
M02;数字代码结束
;接头焊接子程序
O2;焊接程序
Fl;进给率
G05Q1;间歇地缓慢移动/移动到左上角
G91;增量坐标
M8;开气
G4F.5;停留0.5秒
X0.010Y-.004;从接头的角偏移
M71;激光加工并同步进给
X0.015;焊接左焊缝=0.015
M70;停止激光加工
X0.055Y.0045;指向右上角
G05Q1;间歇地缓慢移动/调节到右上角
X-0.010Y-.004;从接头的右上角偏移
M71;激光加工并同步进给
X-0.015;焊接焊缝=0.015
M70;停止激光加工
M9;关气
M99;返回
6mm内径的支架
;6mm内径支架的焊接程序
M61;激光远程控制
;焊接参数
C101Q10;频率10HZ
C102Q0.3;脉冲宽度0.3ms
C108Q300;峰值功率200W
C111Q100;A标度值100
M51;激光监控正常
;移动到通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
Z-2.6716;调节焦点
;焊接六个接头
M26H152;机门复位
M98P2;转到子程序1–第一接头
F4;快速进给以进行内部移动
X-.060Y.045;退回相对原点
M98P2;转到子程序1–第二接头
F4;快速进给以进行内部移动
X-.060Y.045;退回相对原点
M98P2;转到子程序1–第三接头
F4;快速进给以进行内部移动
X-.060Y.045;退回相对原点
M98P2;转到子程序1–第四接头
F4;快速进给以进行内部移动
X-.060Y.045;退回相对原点
M98P2;转到子程序1–第五接头
F4;快速进给以进行内部移动
X-.060Y.045;退回相对原点
M98P2;转到子程序1–第六接头
;返回通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
M25H152;打开机门
M02;数字代码结束
;接头焊接子程序
O2;焊接程序
Fl;进给率
G05Q1;间歇地缓慢移动/移动到左上角
G91;增量坐标
M8;开气
G4F.5;停留0.5秒
X0.010Y-.005;从接头的角偏移
M71;激光加工并同步进给
X0.015;焊接左焊缝=0.015
M70;停止激光加工
X0.075Y.005;指向右上角
G05Q1;间歇地缓慢移动/调节到右上角
X-0.010Y-.005;从接头的右上角偏移
M71;激光加工并同步进给
X-0.015;焊接焊缝=0.015
M70;停止激光加工
M9;关气
M99;返回
7mm内径的支架
;7mm内径支架的焊接程序
M61;激光远程控制
;焊接参数
C101Q10;频率10HZ
C102Q0.3;脉冲宽度0.3ms
C108Q300;峰值功率200W
C111Q100;A标度值l00
M51;激光监控正常
;移动到通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
Z-2.6716;调节焦点
;焊接六个接头
M26H152;机门复位
M98P2;转到子程序1–第一接头
F4;快速进给以进行内部移动
X-.060Y.049;退回相对原点
M98P2;转到子程序1–第二接头
F4;快速进给以进行内部移动
X-.060Y.049;退回相对原点
M98P2;转到子程序1–第三接头
F4;快速进给以进行内部移动
X-.060Y.049;退回相对原点
M98P2;转到子程序1–第四接头
F4;快速进给以进行内部移动
X-.060Y.049;退回相对原点
M98P2;转到子程序1–第五接头
F4;快速进给以进行内部移动
X-.060Y.049;退回相对原点
M98P2;转到子程序1–第六接头
;返回通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
M25H152;打开机门
M02;数字代码结束
;接头焊接子程序
O2;焊接程序
F1;进给率
G05Q1;间歇地缓慢移动/移动到左上角
G91;增量坐标
M8;开气
G4F.5;停留0.5秒
X0.010Y-.005;从接头的角偏移
M71;激光加工并同步进给
X0.015;焊接左焊缝=0.015
M70;停止激光加工
X0.075Y.005;指向右上角
G05Q1;间歇地缓慢移动/调节到右上角
X-0.010Y-.005;从接头的右上角偏移
M71;激光加工并同步进给
X-0.015;焊接焊缝=0.015
M70;停止激光加工
M9;关气
M99;返回
8mm内径的支架
;8mm内径支架的焊接程序
M61;激光远程控制
;焊接参数
C101Q10;频率10HZ
C102Q0.3;脉冲宽度0.3ms
C108Q300;峰值功率200W
C111Q100;A标度值l00
M51;激光监控正常
;移动到通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
Z-2.6544;调节焦点
;焊接六个接头
M26H152;机门复位
M98P2;转到子程序1–第一接头
F4;快速进给以进行内部移动
X-.067Y.053;退回相对原点
M98P2;转到子程序1–第二接头
F4;快速进给以进行内部移动
X-.067Y.053;退回相对原点
M98P2;转到子程序1–第三接头
F4;快速进给以进行内部移动
X-.067Y.053;退回相对原点
M98P2;转到子程序1–第四接头
F4;快速进给以进行内部移动
X-.067Y.053;退回相对原点
M98P2;转到子程序1–第五接头
F4;快速进给以进行内部移动
X-.067Y.053;退回相对原点
M98P2;转到子程序1–第六接头
;返回通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
M25H152;打开机门
M02;数字代码结束
;接头焊接子程序
O2;焊接程序
Fl;进给率
G05Q1;间歇地缓慢移动/移动到左上角
G91;增量坐标
M8;开气
G4F.5;停留0.5秒
X0.010Y-.006;从接头的角偏移
M71;激光加工并同步进给
X0.015;焊接左焊缝=0.015
M70;停止激光加工
X0.095Y.006;指向右上角
G05Q1;间歇地缓慢移动/调节到右上角
X-0.010Y-.006;从接头的右上角偏移
M71;激光加工并同步进给
X-0.015;焊接焊缝=0.015
M70;停止激光加工
M9;关气
M99;返回
9mm内径的支架
;9mm内径支架的焊接程序
M61;激光远程控制
;焊接参数
C101Q10;频率10HZ
C102Q0.3;脉冲宽度0.3ms
C108Q300;峰值功率200W
C111Ql00;A标度值l00
M51;激光监控正常
;移动到通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
Z-2.6716;调节焦点
;焊接六个接头
M26H152;机门复位
M98P2;转到子程序1–第一接头
F4;快速进给以进行内部移动
X-.067Y.057;退回相对原点
M98P2;转到子程序1–第二接头
F4;快速进给以进行内部移动
X-.067Y.057;退回相对原点
M98P2;转到子程序1–第三接头
F4;快速进给以进行内部移动
X-.067Y.057;退回相对原点
M98P2;转到子程序1–第四接头
F4;快速进给以进行内部移动
X-.067Y.057;退回相对原点
M98P2;转到子程序1–第五接头
F4;快速进给以进行内部移动
X-.067Y.057;退回相对原点
M98P2;转到子程序1–第六接头
;返回通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
M25H152;打开机门
M02;数字代码结束
;接头焊接子程序
O2;焊接程序
Fl;进给率
G05Q1;间歇地缓慢移动/移动到左上角
G91;增量坐标
M8;开气
G4F.5;停留0.5秒
X0.010Y-.006;从接头的角偏移
M71;激光加工并同步进给
X0.015;焊接左焊缝=0.015
M70;停止激光加工
X0.095Y.006;指向右上角
G05Q1;间歇地缓慢移动/调节到右上角
X-0.010Y-.006;从接头的右上角偏移
M71;激光加工并同步进给
X-0.015;焊接焊缝=0.015
M70;停止激光加工
M9;关气
M99;返回
10mm内径的支架
;10mm内径支架的焊接程序
M61;激光远程控制
;焊接参数
C101Q10;频率10HZ
C102Q0.3;脉冲宽度0.3ms
C108Q300;峰值功率200W
C111Q100;A标度值l00
M51;激光监控正常
;移动到通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
Z-2.6716;调节焦点
;焊接六个接头
M26H152;机门复位
M98P2;转到子程序1–第一接头
F4;快速进给以进行内部移动
X-.067Y.061;退回相对原点
M98P2;转到子程序1–第二接头
F4;快速进给以进行内部移动
X-.067Y.061;退回相对原点
M98P2;转到子程序1–第三接头
F4;快速进给以进行内部移动
X-.067Y.061;退回相对原点
M98P2;转到子程序1–第四接头
F4;快速进给以进行内部移动
X-.067Y.061;退回相对原点
M98P2;转到子程序1–第五接头
F4;快速进给以进行内部移动
X-.067Y.061;退回相对原点
M98P2;转到子程序1–第六接头
;返回通常工作位置
G90;绝对坐标
F50;进给率
X3.93Y-4.6;定位于固定装置和部件
M25H152;打开机门
M02;数字代码结束
;接头焊接子程序
O2;焊接程序
Fl;进给率
G05Q1;间歇地缓慢移动/移动到左上角
G91;增量坐标
M8;开气
G4F.5;停留0.5秒
X0.010Y-.006;从接头的角偏移
M71;激光加工并同步进给
X0.015;焊接左焊缝=0.015
M70;停止激光加工
X0.095Y.006;指向右上角
G05Q1;间歇地缓慢移动/调节到右上角
X-0.010Y-.006;从接头的右上角偏移
M71;激光加工并同步进给
X-0.015;焊接焊缝=0.015
M70;停止激光加工
M9;关气
M99;返回
          *         *         *
应当理解的是，本发明方法以及由本发明方法形成的装置并不局限于所公开的特定形式。相反，本发明方法以及由本发明方法形成的装置应当涵盖落入权利要求范围内的所有变型、等同物以及替代物。例如，虽然附图中所示的装置由多根线丝编织而成，但在其它实施方式中，本发明方法可以应用于仅由一根线丝（例如，镍钛金属丝）编织而成的或以其它方式形成的装置。此外，虽然在附图中显示的是支架，但是适于放置到解剖结构内的其它装置，例如过滤器和封堵器均可以根据本发明方法来连接它们的自由线丝端。
权利要求不应被理解为包括装置+功能限制或步骤+功能限制，除非在特定的权利要求中，这种限制分别通过使用短语“装置用于”或“步骤用于”进行了明确的阐述。

Claims (22)

1.一种自伸展支架的成形方法，该方法包括：
通过在多根线丝中的每一根形成第一弯曲转向部分，以形成所述支架的第一端，每根线丝均包括位于所述第一弯曲转向部分两侧的线丝部分，每个线丝部分包括线丝部分端部：
平纹编织所述线丝部分，在平纹编织所述线丝部分后，每个所述线丝部分的端部编织到邻近所述支架的第一端；
在平纹编织所述线丝部分后，在第一温度下对多根所述线丝加热处理第一加热处理时间；
通过在多根线丝中的每一根形成第二弯曲转向部分，以形成所述支架的第二端部；并且
在形成所述第二弯曲转向部后，在第二温度下对多根所述线丝加热处理第二加热处理时间。
2.根据权利要求1所述的方法，进一步包括将每个线丝部分端部固定到另一个线丝部分端部以形成成对的固定端部。
3.根据权利要求2所述的方法，其中，固定所述成对的固定端部包括将接头结构固定到每个成对的所述固定端部。
4.根据权利要求3所述的方法，其中，固定所述接头结构包括将所述接头结构焊接至所述成对的固定端部。
5.根据权利要求4所述的方法，其中，将所述接头结构焊接至所述成对的固定端部包括激光焊接。
6.根据权利要求4所述的方法，其中，将所述接头结构焊接至所述成对的固定端部包括形成至少两个彼此间隔开的焊接区。
7.根据权利要求3所述的方法，其中，每个接头结构均包括尺寸适于容纳一个所述线丝的通道。
8.根据权利要求3所述的方法，其中，所述接头结构包括弧形条带。
9.根据权利要求3所述的方法，其中，所述接头结构包括镍钛合金。
10.根据权利要求3所述的方法，其中，所述接头结构包括与所述多个线丝相同的材质。
11.根据权利要求3-10中任意一项所述的方法，其中，将所述接头结构固定到成对的所述固定端部包括放射状向与该接头结构交叉的至少一个所述线丝内布置每个所述接头结构。
12.根据权利要求2-10中任意一项所述的方法，其中，固定成对的所述固定端部包括使每个成对的所述固定端部沿所述支架的轴向方向排列成行。
13.根据权利要求2-10中任意一项所述的方法，其中，固定成对的所述固定端部包括使每个成对的固定端部环绕所述支架的外周偏移。
14.根据权利要求2-10中任意一项所述的方法，其中，固定成对的所述固定端部包括使每个成对的所述固定端部与所述支架的第一端间隔开至少两个线丝交叉点。
15.根据权利要求2-10中任意一项所述的方法，其中，固定成对的所述固定端部包括使每个所述线丝部分端部与另一个线丝部分端部首尾相连地排列成行。
16.根据权利要求15所述的方法，其中，使每个所述线丝部分端部与另一个线丝部分端部首尾相连地排列成行包括使每个所述线丝部分端部与另一个线丝部分端部间隔开。
17.根据权利要求1-10中任意一项所述的方法，其中，还包括在形成所述第二弯曲转向部后向后编织一些所述线丝部分，其中向后编织一些所述线丝部分包括从所述支架的第一端穿过所述线丝部分至少两个线丝交叉点。
18.根据权利要求1-10中任意一项所述的方法，进一步包括修整所述线丝部分。
19.根据权利要求1-10中任意一项所述的方法，其中，所述第一加热处理时间与所述第二加热处理时间相同。
20.根据权利要求1-10中任意一项所述的方法，其中，所述第一温度与所述第二温度相同。
21.根据权利要求1-10中任意一项所述的方法，其中，所述第一温度与所述第二温度中的至少一者在510℃至535℃之间。
22.根据权利要求1-10中任意一项所述的方法，其中，所述第一加热处理时间与所述第二加热处理时间中的至少一者在5分钟到13分钟之间。
CN201310576495.8A 2006-10-22 2007-10-22 自伸展支架的成形方法 Expired - Fee Related CN103767810B (zh)

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CN104799983A (zh) * 2015-05-04 2015-07-29 苏州英络医疗器械有限公司 一种无缝支架及制造方法
US10888411B2 (en) 2015-05-04 2021-01-12 Suzhou Innomed Medical Device Co., Ltd. Intravascular stent and manufacturing method thereof
CN105266934A (zh) * 2015-09-17 2016-01-27 常州乐奥医疗科技有限公司 一种编织型的血管支架
CN110037839A (zh) * 2019-05-28 2019-07-23 南京微创医学科技股份有限公司 一种腔内支架及其制备方法
WO2020238168A1 (zh) * 2019-05-28 2020-12-03 南微医学科技股份有限公司 一种腔内支架及其制备方法
CN110037839B (zh) * 2019-05-28 2024-03-12 南微医学科技股份有限公司 一种腔内支架及其制备方法
CN112472953A (zh) * 2020-12-03 2021-03-12 广东博迈医疗器械有限公司 一种带有加强筋的编织导管
CN116370008A (zh) * 2023-04-24 2023-07-04 上海励楷科技有限公司 多节距编织支架
CN116370008B (zh) * 2023-04-24 2024-01-30 上海励楷科技有限公司 多节距编织支架

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