CN103298427A - 偏置的管腔内装置 - Google Patents
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Abstract
管腔内装置可包括柔性管状壁和框架构件。该框架构件由形状记忆材料制成,并具有带有突出部的侧面,这些突出部在与柔性管状壁一起形成时被部分地或基本上拉平,以由此在管腔内装置的侧壁内形成偏置,该偏置使在挤压加载过程中防止从期望的装置变形,并由此防止在展开时出现内陷。
Description
背景
相关申请的交叉引用
本申请是2010年12月22日提交的、题为“Deployment of EndoluminalDevices(管腔内装置的展开)”的美国临时专利申请第61/425,882的非临时申请并且要求了它的优先权,其全部主题内容以参见的方式纳入本文。
领域
本发明涉及改进的用于治疗血管疾病的可扩张管腔内装置。
相关技术的讨论
为了便于递送到治疗部位,可将可扩张管腔内装置(例如,支架移植物)挤压加载到管状元件上,并由护套或其它管状元件来保持。一旦递送通过曲折的血管结构,在治疗部位使管腔内装置从递送装置展开。
在一些情况下,挤压会造成管腔内装置的内褶或内陷(invagination),特别是在其横截面轮廓并不是弯曲的之处,正如有时在分叉部或以其它方式渐缩的部分的情况那样。
仍期望提供在挤压过程中防止内褶或内陷的管腔内装置,以及用于制造这种管腔内装置的方法。
附图说明
在下述附图中:
图1示出根据各种实施例的用于形成管腔内装置用的线材支架或框架构件的芯轴。
图2示出根据各种实施例的支架或框架构件的端视图。
图3示出根据各种实施例的管腔内装置的正视图。
图4是根据各种实施例的图3中管腔内装置的剖视图,其示出用于防止在挤压和展开过程中变形的向外结构偏置。
具体实施方式
本领域的技术人员应容易理解到可以通过任意数量的构造成实现所需功能的方法和设备来实现本发明的各个方面。换言之,其它方法和设备可包含到文中以实现既定的功能。还应注意,本文中的附图并不是全部按比例绘制的,而是可以放大以示出本发明的各个方面,在此方面,附图不应理解为是限制性的。最后,尽管本发明可结合各种原理和理念来描述,但本发明不应受理论的限制。
根据各种实施例,管腔内装置包括柔性管状壁和框架构件,该框架构件具有一偏置,以防止管状壁从期望的轮廓变形,诸如是内褶或内陷。
根据各种实施例,管腔内装置可以是包括具有期望轮廓的横截面轮廓的部分和例如在装置沿曲折的解剖体展开过程中保持装置的期望的横截面轮廓的结构偏置的任何支架移植物。
根据各种实施例,管腔内装置可以例如在支架移植物从较大周界过渡到较小周界的分叉部或以其它方式渐缩的部分内具有大致不弯曲的部段。
在各种实施例,框架构件包括适用于治疗诸如腹腔动脉瘤的血管病症的支架,并可提供用于管腔内装置和/或血管结构的柔性管状壁的结构支承。框架构件可包括具有螺旋形构造的线材或者一个或多个环。此外,线材或环本身可以是直线的或者具有正弦或之字形样式。框架构件的其它各种实施例可由管子切出,并具有适用于治疗的任何样式。
在各种实施例中,框架构件包括形状记忆材料,诸如镍钛诺。在各种实施例中,框架构件可包括其它材料、自扩张或其它方式可扩张(例如,借助囊体或弹簧机构),诸如各种金属(例如,不锈钢)、合金和聚合物。
在各种实施例中,框架构件包括用于在框架构件与移植物各层组装和/或组装在移植物各层之间以形成管腔内装置时形成偏置的一个或多个突出部。一般来说,突出部包括任何凸起、脊部、凸出部、凹槽、凹陷部或其它向外或向内延伸的特征,这种特征在不与移植物层组装和/或不组装在移植物层之间时与管腔内装置明显不同。
在各种实施例中,突出部的特征可以在于限定内腔的框架构件,该内腔包括其横截面面积比柔性管状壁和/或管腔内装置的对应部分的横截面面积大或小的部分(例如,周缘或中间部分)。横截面形状可以是五边形、八边形或任何其它合适的形状。
在各种实施例中,框架构件构造成具有凸出或向外延伸的突出部。然而,突出部可以沿任何方向大致构造有在管腔内装置中是期望的内部结构偏置。
突出部可制成到框架构件内或在制造之后以其它方式引入。在各种实施例中,通过是柔性管状壁和/或管腔内装置的期望直径或宽度的约5%到约25%的突出部来实现合适的偏置。管腔内装置例如可与具有柔性管状壁和/或管腔内装置的直径或宽度的约10%的突出部的框架构件一起制成。一般来说,相对于柔性管状壁和/或管腔内装置的期望直径或宽度来说较大的突出部尺寸会造成较大偏置,以阻止管腔内装置在突出部处或附近内褶或内陷。
在各种实施例中,柔性管状壁一般是任何近腔和/或腔覆盖物,该覆盖物构造成部分地或基本上弄平、拉平或以其它方式减小框架构件的突出部,并由此使框架构件突出部顺应于管腔内装置的期望尺寸和轮廓。
在各种实施例中,框架的形状为大致圆锥形,并由柔性管状壁约束成大致圆筒形。在各种实施例中,柔性管状壁限定不包括在框架构件中存在的突出部的表面。在各种实施例中,柔性管状壁的一部分(例如,周缘或中间部分)具有不包括存在于框架构件的对应部分内的突出部的横截面区域。
在各种实施例中,柔性管状壁包括带状ePTFE。用于柔性管状壁的其它有用的材料可包括尼龙、聚碳酸酯、聚乙烯、聚丙烯、聚四氟乙烯、聚氯乙烯、聚氨酯、聚硅氧烷、和其它生物相容材料中的一种或多种。
在各种实施例中,柔性管状壁在一个或多个位置例如采用热缩、粘附或本领域已知的其它工艺牢固地固定到或以其它方式联接到框架构件的近腔或腔表面。在各种实施例中,将柔性管状壁联接到从框架向外延伸并大致在框架突出部近侧的锚定件。在各种实施例中,采用多个柔性管状壁,这些壁联接到框架构件的近腔和腔表面。
各种实施例包括一个或多个柔性管状壁,这些柔性管状壁在框架构件突出部处或沿框架构件突出部或在其附近联接到框架构件,以部分地或基本上弄平、拉平或以其它方式减小框架构件突出部,并由此在装置处于未约束状态下时产生沿突出部方向的内部结构偏置。
在各种实施例中,框架构件突出部在联接到或以其它方式与柔性管状壁一起形成时部分或大致是平坦的。将框架构件的突出部拉平可在管腔内装置中产生结构偏置,该结构偏置防止沿大致与突出部相反的方向的径向变形(例如,内褶或内陷),或以其它方式防止在挤压加载过程中从其横截面形状变形,并在展开并且装置处于未约束状态时保持其结构整体性。
在各种实施例中,管腔内装置具有围绕大致垂直于其内腔的纵向轴线的横截面沿周向或沿周缘变化的抗径向变形力。这种抗径向变形力可以在一个或多个柔性管状壁联接到框架构件的中间部分达到峰值。
在各种实施例中,用于制成偏置的管腔内装置的方法可包括在第一芯轴上形成框架构件,该第一芯轴具有与管腔内装置在突出部处或附近的期望轮廓相比包括一个或多个突出部的表面。然后,管腔内装置可通过如下方式来形成,即,将柔性管状壁卷绕在不包括突出部的第二芯轴上的框架构件周围,随后使柔性管状壁热缩到框架构件。
示例性管腔内装置随后能在不期望的变形、诸如是内褶或内陷的可能性减小的情况下来径向挤压加载。将支承囊体引入管腔内装置的内腔,并在径向挤压加载过程中放气,以进一步减小不期望的变形的可能性。
参照图1、2、3和4来描述本发明的各种实施例。具体来说,参照图1,将用于形成诸如支架的框架构件的芯轴40设置成具有装置从较大周界过渡到较小周界的锥形部42。锥形部42可包括例如0.05英寸的脊状突出部44。然而,根据框架形状和所需的结构偏置量可以采用或大或小的突出部以及形状不同的突出部。
将镍钛诺支架框架构件30卷绕在芯轴40上,由此如图2的端视图中说明性地示出那样在框架构件30的锥形部中形成对应的0.05英寸的脊状突出部32。然后,使框架构件30卷绕有ePTFE柔性管状壁20,以拉平脊状突出部32。在图3和4中示出所得的管腔内装置10。为了便于比较,图4中的点划线32’示出与移植物层一起组装和/或组装在移植物层之间以形成装置的框架构件的轮廓。由此,应容易理解到在组装装置之前的未约束的框架构件32’与在与移植物层一起组装和/或组装在移植物层之间之后沿突出部32的框架构件之间的轮廓差或位置差总地表示结构偏置,该结构偏置防止装置沿框架构件的具有突出部的部分内褶或内陷。
管腔内装置10可用径向挤压器来进行径向挤压加载。由于突出部32提供的内部结构偏置(在图4中由附图标记22表示),锥形部阻止在径向挤压器的挤压力下向内偏转。然后,管腔内装置10由护套或其它管状元件保持、递送通过曲折的血管结构并在治疗部位处展开,而没有内褶或内陷。
根据各种实施例,可以例如由切割管、缠绕线材(或带)或卷成管状的平板制成支架,这些支架具有用于形成防止管腔内装置从期望的轮廓变形的结构偏置的突出部。支架可由金属、聚合物或天然材料制成,并可包括:传统医疗级别的材料,诸如尼龙、聚丙烯酰胺、聚碳酸酯、聚乙烯、聚甲醛、聚甲基丙烯酸甲酯、聚丙烯、聚四氟乙烯,聚三氟氯乙烯、聚氯乙烯、聚氨酯、弹性有机硅聚合物;诸如不锈钢、钴铬合金和镍钛诺的金属以及诸如牛动脉/静脉、心包膜和胶原的生物衍生材料。支架还可包括可生物可吸收材料,诸如聚(氨基酸类)、聚(酐),聚(己内酯),聚(乳酸/乙醇酸)聚合物,聚(羟基丁酸盐)和聚(原酸酯)。
用于移植物构件的可能材料包括例如膨胀型聚四氟乙烯(ePTFE)、聚酯、聚氨基甲酸乙酯、诸如全氟弹性体之类的含氟聚合物,聚四氟乙烯、硅酮、聚氨酯、超高分子量聚乙烯、芳族聚酰胺纤维及其组合。用于移植物材料的一个较佳的实施例是ePTFE。用于移植物构件材料的其它实施例可包括高强度聚合物纤维,诸如超高分子量聚乙烯纤维(例如,Dyneema等)或者芳纶纤维(例如等)。移植物构件可包括生物活性剂。在一个实施例中,ePTFE移植物沿其与血液接触的表面包括碳成分。
用于如上所述构造用于装置的管腔内递送的导管的典型材料可包括通常已知的材料,诸如无定形商用热塑性塑料,其包括聚甲基丙烯酸甲脂(PMMA或丙烯酸)、聚苯乙烯(PS)、丙烯腈-丁二烯-苯乙烯(ABS)、聚氯乙烯(PVC)、改性的聚对苯二甲酸乙二醇酯(PETG)、醋酸丁酸纤维素(CAB);半晶态商用塑料,其包括聚乙烯(PE)、高密度聚乙烯(HDPE)、低密度聚乙烯(LDPE或LLDPE)、聚丙烯(PP)、聚甲基戊烯(PMP);无定形工程热塑性塑料,其包括聚碳酸酯(PC)、聚苯醚(PPO)、改性的聚苯醚(ModPPO)、聚丙乙烯(PPE)、改性的聚丙乙烯(Mod PPE)、热塑性聚氨酯(TPU);半晶态工程热塑性塑料,其包括聚酰胺(PA或尼龙)、聚甲醛(POM或乙缩醛)、聚对苯二甲酸乙二酯(PET,热塑性聚酯)、聚对苯二甲酸丁二酯(PBT,热塑性聚酯)、超高分子量聚乙烯(UHMW-PE);高性能热塑性塑料,其包括聚酰亚胺(PI,酰亚胺化塑料)、聚酰胺-酰亚胺(PAI,酰亚胺化塑料)、聚苯并咪唑(PBI,酰亚胺化塑料);无定形高性能热塑性塑料,其包括聚砜(PSU)、聚醚酰亚胺(PEI)、聚醚砜(PES)、聚芳基砜(PAS);半晶态高性能热塑性塑料,其包括聚苯硫醚(PPS)、聚醚醚酮(PEEK);以及半晶态高性能热塑性塑料、氟聚合物,其包括氟化乙烯丙烯(FEP)、乙烯-三氟氯乙烯共聚物(ECTFE)、乙烯、乙烯-四氟乙烯共聚物(ETFE)、聚三氟氯乙烯(PCTFE)、聚四氟乙烯(PTFE),聚偏氟乙稀(PVDF)、全氟烷氧基树脂(PFA)。其它公知的医疗级材料包括弹性有机硅聚合物、聚醚嵌段酰胺或热塑性共聚醚(PEBAX)和金属,如不锈钢和镍/钛合金等。
对于本领域技术人员来说明显的是,可在本发明内作出各种修改和变型而不脱离本发明的精神和范围。因此,本发明旨在涵盖其任何改型和变型,只要它们落在所附权利要求及其等同物的范围内即可。
Claims (15)
1.一种管腔内装置,包括:
柔性管状壁,所述柔性管状壁限定具有第一周缘横截面形状的内腔;以及
框架构件,所述框架构件具有与所述第一周缘横截面形状不同的第二周缘横截面形状,并联接到所述柔性管状壁,以提供结构支承,
其中,所述柔性管状壁牢固地固定到所述框架构件的至少一部分,并在所述装置处于未约束状态时使所述框架构件的所述至少一部分连续偏置,以防止所述内腔从所述第一周缘横截面形状变形。
2.如权利要求1所述的管腔内装置,其特征在于,所述柔性管状壁牢固地固定到所述框架构件的至少一部分,并在所述装置处于未约束状态时使所述框架构件的所述至少一部分连续偏置,以防止所述柔性管状壁的内陷。
3.如权利要求1所述的管腔内装置,其特征在于,所述管腔内装置具有抗径向变形力,所述径向变形绕大致垂直于所述内腔的纵向轴线的横截面沿周向变化。
4.如权利要求3所述的管腔内装置,其特征在于,所述抗径向变形力一般在所述柔性管状壁牢固地固定到所述框架构件的所述至少一部分的中间部分处达到峰值。
5.如权利要求4所述的管腔内装置,其特征在于,所述抗径向变形力在沿周向围绕所述框架构件的多个位置处达到峰值。
6.一种管腔内装置,包括:
框架,所述框架具有初始制造形状;
柔性管状壁,所述柔性管状壁形成具有预定周缘横截面形状的内腔,所述柔性管状壁牢固地固定到所述框架,并使所述框架从所述初始制造形状变形,因而,变形的框架防止所述柔性管状壁变形。
7.如权利要求6所述的管腔内装置,其特征在于,所述框架的所述初始制造形状包括大致向外延伸的突出部。
8.如权利要求7所述的管腔内装置,其特征在于,所述突出部通过与其牢固地固定的所述柔性管状壁而径向向内变形,以在所述框架内产生防止所述柔性管状壁内陷的偏置。
9.如权利要求6所述的管腔内装置,其特征在于,所述框架的所述初始制造形状为大致圆锥形。
10.如权利要求9所述的管腔内装置,其特征在于,所述柔性管状壁牢固地固定到所述框架,并使所述框架约束到大致圆筒形形状。
11.如权利要求7所述的管腔内装置,其特征在于,包括从所述框架向外延伸并大致在所述突出部近侧的锚定件。
12.一种用于制成偏置的管腔内装置的方法,包括:
提供具有第一横截面面积的框架构件;以及
提供具有比所述第一横截面面积小的第二横截面面积的柔性管状壁,
其中,将所述柔性管状壁牢固地固定到所述框架构件的至少一部分,并在所述装置处于未约束状态时使所述框架构件的所述至少一部分连续偏置,以防止所述装置向内变形。
13.一种如权利要求12中所述的用于制成偏置的管腔内装置的方法,还包括将柔性管状壁卷绕在具有比所述第一横截面面积小的第二横截面面积的芯轴上的所述框架构件周围。
14.一种如权利要求12中所述的用于制成偏置的管腔内装置的方法,其中,所述框架构件包括镍钛诺。
15.一种如权利要求12中所述的用于制成偏置的管腔内装置的方法,其中,所述柔性管状壁包括ePTFE。
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EP2654619B1 (en) | 2021-01-27 |
AU2011349406A1 (en) | 2013-07-04 |
RU2013134004A (ru) | 2015-01-27 |
US20120323304A1 (en) | 2012-12-20 |
JP2014503293A (ja) | 2014-02-13 |
CA2821724C (en) | 2017-05-16 |
ES2861424T3 (es) | 2021-10-06 |
US20230414341A1 (en) | 2023-12-28 |
WO2012088017A3 (en) | 2012-08-16 |
US10617514B2 (en) | 2020-04-14 |
EP2654619A2 (en) | 2013-10-30 |
US11786356B2 (en) | 2023-10-17 |
CN103298427B (zh) | 2016-06-29 |
AU2015238886A1 (en) | 2015-10-29 |
JP6117704B2 (ja) | 2017-04-19 |
US20200289254A1 (en) | 2020-09-17 |
CA2821724A1 (en) | 2012-06-28 |
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