CN105380736B - 具有增强的射线不可透过性的多股植入物 - Google Patents

具有增强的射线不可透过性的多股植入物 Download PDF

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CN105380736B
CN105380736B CN201510535841.7A CN201510535841A CN105380736B CN 105380736 B CN105380736 B CN 105380736B CN 201510535841 A CN201510535841 A CN 201510535841A CN 105380736 B CN105380736 B CN 105380736B
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R.特拉尼
R.斯拉扎斯
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DePuy Synthes Products Inc
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Abstract

本发明题为“具有增强的射线不可透过性的多股植入物”。本发明提供了一种用于医疗用途的植入物和制作用于医疗用途的植入物的方法，所述植入物具有由第一材料的多个单股形成的主体。该主体还包括结合在单股之间的射线不可透过的材料的至少一个多股，所述多股具有射线不可透过的材料基本上在多股的整个长度上基本上彼此连续平放的至少两个并列细丝。

Description

具有增强的射线不可透过性的多股植入物
背景技术
1.技术领域
本发明涉及身体血管内的植入物且更具体地涉及偏流器、支架和由多股材料形成并具有射线不可透属性的其他植入物。
2.相关领域说明
诸如动脉瘤和其他动静脉畸形的血管疾病和缺陷在位于关键组织附近或者无法随时到达畸形的部位时，对其进行治疗就尤为困难。这两个难点对于颅内动脉瘤而言尤其如此。由于颅内血管周围的脑组织很敏感且进入受限，因此手术治疗颅内脉管系统缺陷非常具有挑战性并且常常很危险。
多个血管闭塞装置已经由金属线、编织纤维和/或织造纤维的螺旋绕组或线圈形成。由非金属纤维形成的植入物或由具有低放射密度的其他材料形成的植入物难以在通过脉管系统的插入、在选定位点处的放置和可能的随后恢复期间跟踪。射线不可透过的纤维已添加到诸如由Engelson等人在美国专利5,423,849中描述的植入物。然而，射线不可透过的纤维的直径常常非常小，通常介于0.0005英寸至0.005英寸之间，且单股的这些纤维难以在由荧光镜透视检查或其他观察技术进行的成像期间看到。射线不可透过的材料包括铂、铬、钴、钽、钨、金、银和它们的合金。
根据期望的射线不可透过性的水平，一些技术是已知的，以在成像期间增加植入物的可视性。附加股的射线不可透过的材料添加到植入物，个别股的直径增加，并且/或者如通过形成线圈，射线不可透过的材料的体积增加。然而，添加附加股的射线不可透过的材料可以改变植入物的机械性能，尤其是对于利用由诸如镍钛的形状记忆合金制成的股的植入物。增加植入物的个别射线不可透过的股的直径不仅潜在地影响该植入物的机械性能，而且增加该植入物的壁厚。同样，通过将射线不可透过的细丝卷绕成线圈并将其添加到植入物来增加射线不可透过的材料的体积将影响植入物的机械性能以及植入物的壁厚两者。
加强纺织物假体的复合纱由Dong在美国专利公布2005/0288775中公开。可包括编织节段的血液偏流器由Gobran等人在美国专利公布2007/0060994中描述。用作过滤器的具有射线不可透过的网片的支架由Zaver等人在美国专利8,394,119中提出。具有用于腔内装置的复合纱的织造织物由Rasmussen等人在美国2012/0168022中描述。
另一种类型的血管闭塞装置由Horton在美国专利5,645,558中示出为具有经卷绕当在放置在诸如动脉瘤或瘘管的血管腔体中之后松弛时形成大体球形或卵形血管闭塞结构的一股或多股柔性材料。相似地，Guglielmi的美国专利5,916,235引用描述可拆卸线圈的早先专利，且然后公开可膨胀式保持架作为在保持架在动脉瘤内膨胀之后可以接收并保持一个或多个栓塞线圈的血管闭塞结构。可自膨胀式的动脉瘤填充装置由Veznedaroglu等人在美国专利公布2010/0069948中公开。
通常，首先使用递送导管将类支架血管重建装置引导至待治疗的动脉瘤下方。例如，一种可商购获得的重建产品是如例如马萨诸塞州雷纳姆派拉蒙大道325号的Codman&Shurtleff公司在导航坚韧解剖宣传册版权2009中所述的CODMAN血管重建装置和系统。CODMAN支架装置由中心递送线承载并且初始由护套型导引器保持在收缩状态的递送线上的适当位置。通常，可从Codman&Shurtleff商购获得并且由Gore等人在美国专利5,662,622中公开的诸如 Plus微导管的递送导管例如首先定位在血管内，并且其远侧末端稍微超出动脉瘤的颈部。该导引器的锥形远侧末端与递送导管的近端衬套紧密配合，然后推进递送线穿过递送导管。
CODMAN支架装置具有高度柔性的自膨胀闭孔设计，该闭孔设计在装置的每个扩口端具有射线不可透过的线材的多个线圈充当标记物，类似于在以上引用的Jones等人所公布的专利申请中示出的支架。由于支架的尺寸小并且需要多次围绕支架上的支柱缠绕射线不可透过的线材，这在支架的闭孔内尤其困难，所以这些标记物的制造相对耗时和昂贵。
因此，希望在最小化对植入物性能的影响时以成本有效的方式增加植入物的射线不可透过性。
发明内容
本发明的目的是在最小化植入物制造过程的变化时增加具有多个股的植入物的射线不可透过性。
本发明的另一个目的是在没有不利地影响植入物性能的情况下增强射线不可透过性。
本发明的另外目的是在最小化对植入物的机械属性的影响和保持类似壁厚时增加射线不可透过性。
本发明源于这样的实现，即两股或更多股的射线不可透过的材料可以并列放置在单个载体上作为多股，这可在植入物的制造期间以与单股相同的方式处理。
本发明的特征在于一种用于医疗用途的植入物，其包括具有主体的结构，该主体被构造成包括由至少第一材料构成的多个单股。该主体还包括结合在单股之间的射线不可透过的材料的至少一个多股，所述多股具有射线不可透过的材料的基本上在多股的整个长度上基本上彼此连续平放的至少两个并列细丝。
在一些实施例中，该多股的并列细丝中的每个是射线不可透过的材料的单丝。优选地，每个并列细丝的直径基本上与单股的直径相同。
本发明的特征还在于一种具有主体壁的植入物，该主体壁由第一材料的多个单股形成，从而建立诸如基本上管状形状的开放编织图案或开放织造图案的第一间距图案和第一壁厚。主体壁还包括与单股交替的射线不可透过的材料的多个多股，每个多股具有射线不可透过的材料的基本上彼此连续平放的至少两个并列细丝，并且每个多股在第一间距图案中连接，而不从该图案基本上偏离且基本上不改变第一壁厚。
本发明的特征还在于一种制造用于医疗用途的植入物的方法，该方法包括提供多个载体，每个载体具有第一材料的单股，以及提供具有射线不可透过的材料的多股的至少一个载体，该多股具有射线不可透过的材料的基本上在多股的整个长度上基本上彼此连续平放的至少两个并列细丝。该方法还包括利用单股和多股两者形成植入物的主体，其优选地具有基本上恒定的壁厚。
在一些实施例中，具有多股的载体基本上与用于单股的载体相同。该多股的并列细丝中的每个是射线不可透过的材料的单丝。优选地，每个并列细丝的直径基本上与单股的直径相同。在多个实施例中，形成主体包括建立第一间距图案，并且每个多股在第一间距图案中连接，而不从该图案基本上偏离。在某些实施例中，第一间距图案是开放编织图案和开放织造图案中的一个。在一些实施例中，至少一个多股载体用于每打单股载体，诸如具有至少42个载体的机器，并且该载体中的至少6个载体装载有射线不可透过的材料的多股。
本发明的特征还在于一种改造形成具有多个载体的机器的植入物的方法，每个载体被设计成承载由第一材料和射线不可透过的材料中的至少一个构成的单股。该方法包括选择多个载体中的至少一个以及用射线不可透过的材料的多股装载所选择的载体。多股具有射线不可透过的材料的基本上在所述多股的整个长度上基本上彼此连续平放的至少两个并列细丝。该方法还包括利用射线不可透过的材料的单股和射线不可透过的材料的一个或多个多股两者形成植入物的主体。
附图说明
下面结合附图更详细地解释本发明的优选实施例，其中：
图1是根据本发明的由单股和一个或更多个射线不可透过的多股形成的植入物主体的一部分的示意性放大视图；
图2是根据本发明的具有交替的单股和多股的管状编织植入物的示意性侧视图；
图3是根据本发明的具有单股和多股的更复杂图案的管状编织植入物的示意性侧视图；以及
图4是根据本发明的形成包括在植入物的制造期间提供射线不可透过的多股的常规载体的机器的植入物的一部分的示意图。
具体实施方式
本发明可以由用于医疗用途的植入物和制作用于医疗用途的植入物的方法完成，植入物包括具有至少部分构造有由第一材料构成的多个单股的主体的结构。该主体还包括结合在单股之间的射线不可透过的材料的至少一个多股，所述多股具有射线不可透过的材料的平行于彼此的至少两个并列细丝，即，细丝基本上在多股的整个长度上基本上彼此连续平放。合适的植入物包括偏流器、支架、过滤器、外科网片和由多股材料形成且从增强的射线不可透过属性受益的其他植入物或其部分。
术语“股”在其最广泛意义上意在包括线材、纤维、细丝或其他单个细长构件。术语“射线不可透过”用于放射密度的正常意义，也就是说，由抑制电磁辐射通过以在成像期间增加可视性的一种或多种材料形成。根据本发明使用的合适的射线不可透过的材料包括铂、铬、钴、钽、钨、金、银和它们的合金。
图1是由至少第一材料构成的单股12和一个或多个射线不可透过的多股14形成的根据本发明的植入物主体10的一部分的示意性放大视图。在该构造中，主体10被织造成包括至少第二多股16。在由虚线指示的另一个构造中，主体10还包括由单丝22和24形成的多股18和20，单丝22和24各自分别与单丝26和28放置在一起。
在一些构造中织造且在其他构造中编织的主体10的图案包括由在第一方向上取向的单股12和由在例如横向于第一方向的第二方向上取向的单股24和25限定的开口30。主体10还包括由在与多股14相同的方向上取向的单股13和15和由在横向方向上取向的单股24、25和27限定在多股14的任一侧上的开口32和34。在一些构造中，开口32和34稍微比仅由单股限定的开口30大；在其他构造中，所有开口30、32和34基本上相同。所有这些构造被认为具有基本上相同的图案，好像主体10仅仅由材料的单股形成那样。
由于多股以相同的方式编织、织造或以其他方式平行于彼此放置，好像利用射线不可透过的材料的单股那样，并且尤其是当多股的每个细丝具有与单股相同的直径时，对于诸如柔韧性、膨胀能力和卷曲轮廓的植入物性能具有很少机械影响或无机械影响。
图2的管状编织植入物40基本上是圆柱形、中空和多孔结构，诸如根据本发明的一个构造的具有由交替单股42和多股44形成的主体41的支架或偏流器。主体41限定中心管腔46。单股50、52、54和56当在第一方向上取向时是可见的并且与多股60、62、64、66和68交替。单股70、72、74和76当在第二方向上取向时是可见的并且与多股80、82和84交替。在一些构造中，单独编号的单股中的两个或更多个实际上是如对编织和织造领域中的普通技术人员将显而易见的单个、连续单股的不同部分。相似地，单独编号的多股中的两个或更多个实际上是单个、连续多股的不同部分。
图3是根据本发明的另一个构造的具有与三个多股94交替的三个单股92的更复杂图案的交替管状编织植入物90的示意性侧视图。当利用荧光镜透视检查或其他成像技术在患者体内观察时，植入物40和90各自将产生不同的图像，这帮助外科医生或其他使用者将其从其他植入物和解剖特征部辨别出来。在一些构造中，植入物40和/或90限定直径范围从2.0mm至约5.0mm的内管腔。
本发明也可以由制造用于医疗用途的植入物的方法完成，该方法包括提供多个载体，每个载体具有第一材料的单股，以及提供具有射线不可透过的材料的多股的至少一个载体，该多股具有射线不可透过的材料基本上在多股线的整个长度上基本上彼此连续平放的至少两个并列细丝。该方法还包括利用单股和多股两者形成植入物的主体，其优选地具有基本上恒定的壁厚。
图4是根据本发明的形成包括在植入物110的制造期间所示的常规单股载体102和104的机器100的植入物的一部分的未按比例绘制的示意图。载体102装载有单股103，而载体104装载有射线不可透过的多股105。虚线部件120和122表示用于分别引导单股103和多股105的常规机构，以形成植入物110，如相关领域的普通技术人员将理解的。
为了便于说明，图1-4中所示的股的图案是1股在1股上的编织类型图案。如由普通技术人员在研究本公开之后也将理解的，根据本发明可以使用其他编织、针织或织造图案，如1股在2股上图案、2股在2股上图案和其他已知图案。根据常规技术调节在植入物形成期间放置在每股上的张力。
根据本发明的另一种技术是改造形成具有诸如载体102和104的多个载体的机器的植入物，每个载体被设计成承载由第一材料和射线不可透过的材料中的至少一个构成的单股。该技术包括选择多个载体中的至少一个，诸如载体104，并且用射线不可透过的材料的多股装载所选择的载体。多股具有射线不可透过的材料基本上在所述多股的整个长度上基本上彼此连续平放的至少两个并列细丝。利用单股和多股两者形成植入物的主体。
在优选技术中，该多股的并列细丝中的每个是射线不可透过的材料的单丝。在一个构造中，具有多股的载体基本上与用于单股的载体相同。所述多股的并列细丝中的每个是射线不可透过的材料的单丝。优选地，每个并列细丝的直径基本上与单股的直径相同。形成主体包括建立诸如开放编织图案或开放织造图案的第一间距图案以及第一壁厚，并且每个多股在第一间距图案中连接，而不从该图案基本上偏离且基本上不改变第一壁厚。
在某些技术中，至少一个多股载体用于每打单股载体。一些机器具有至少42个载体，诸如48个载体，并且所述载体中的至少6个载体诸如8个载体装载有射线不可透过的材料的多股。这仍然导致48载体编织，但当8个载体装载有射线不可透过的材料的单股时具有射线不可透过的股的数量的双倍。
因此，尽管已经示出、描述和指出了应用于其优选实施例的本发明的基本新颖特征，但应该理解，在不脱离本发明的精神和范围的情况下，本领域技术人员可对所示装置及其操作进行形式和细节上的各种省略、替换和改变。例如，明确预期的是以基本上相同的方式执行基本上相同的功能以实现相同结果的那些元件和/或步骤的所有组合均在本发明的范围内。元件从一个描述的实施例替换到另一实施例也是完全可以预期和想到的。还应当理解，附图未必按比例绘制，但它们在本质上仅仅是概念性的。因此，只意图如所附权利要求书中的范围所指出的那样进行限制。
本文引用的每一公布的专利、待审的专利申请、专利公开、期刊文章、书籍或任何其他参考文献均全文以引用方式并入。

Claims (15)

1.一种用于医疗用途的植入物，包括具有主体壁的结构，所述主体壁由至少第一材料构成的多个单股形成，从而建立第一间距图案和第一壁厚，所述主体壁包括与所述单股交替的射线不可透过的材料的多个多股，每个多股具有射线不可透过的材料的基本上彼此邻近放置的至少两个并列细丝，并且每个多股在所述第一间距图案中连接，而不从所述图案基本上偏离且基本上不改变所述第一壁厚，
其中，由所述单股和所述多股形成的所述植入物的主体具有基本上恒定的壁厚。
2.根据权利要求1所述的植入物，其特征在于，所述多股的所述并列细丝中的每个是射线不可透过的材料的单丝。
3.根据权利要求1所述的植入物，其特征在于，所述第一间距图案是开放编织图案和开放织造图案中的一个。
4.一种制造用于医疗用途的植入物的方法，包括：
提供多个载体，每个载体具有由至少第一材料构成的单股；
提供具有射线不可透过的材料的多股的至少一个载体，所述多股具有射线不可透过的材料的基本上在所述多股的整个长度上基本上彼此邻近放置的至少两个并列细丝；以及
利用所述单股和所述多股两者形成所述植入物的主体，
其中，由所述单股和所述多股形成的所述植入物的主体具有基本上恒定的壁厚。
5.根据权利要求4所述的方法，其特征在于，具有所述多股的所述载体基本上与用于所述单股的所述载体相同。
6.根据权利要求5所述的方法，其特征在于，所述多股的所述并列细丝中的每个是射线不可透过的材料的单丝。
7.根据权利要求6所述的方法，其特征在于，形成所述主体包括建立第一间距图案和第一壁厚，并且每个多股在所述第一间距图案中连接，而不从所述图案基本上偏离且基本上不改变所述第一壁厚。
8.根据权利要求7所述的方法，其特征在于，所述第一间距图案是开放编织图案和开放织造图案中的一个。
9.根据权利要求7所述的方法，其特征在于，至少一个多股载体用于每打单股载体。
10.一种改造具有多个载体的形成植入物的机器的方法，每个载体被设计成承载由第一材料和射线不可透过的材料中的至少一个构成的单股，所述方法包括：
选择所述多个载体中的至少一个，并且用射线不可透过的材料的多股装载所选择的载体，所述多股由射线不可透过的材料的基本上在所述多股的整个长度上基本上彼此邻近放置的并排的两个并列细丝组成；以及
利用所述单股和所述多股两者形成所述植入物的主体，
其中，由所述单股和所述多股形成的所述植入物的主体具有基本上恒定的壁厚。
11.根据权利要求10所述的方法，其特征在于，所述多股的所述并列细丝中的每个是射线不可透过的材料的单丝。
12.根据权利要求11所述的方法，其特征在于，形成所述主体包括建立第一间距图案和第一壁厚，并且每个多股在所述第一间距图案中连接，而不从所述图案基本上偏离且基本上不改变所述第一壁厚。
13.根据权利要求12所述的方法，其特征在于，所述第一间距图案是开放编织图案和开放织造图案中的一个。
14.根据权利要求12所述的方法，其特征在于，至少一个多股载体用于每打单股载体。
15.根据权利要求13所述的方法，其特征在于，所述机器具有至少42个载体，并且所述载体中的至少6个载体装载有所述射线不可透过的材料的多股。
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