CN104887365B - 用于支持斑块贴靠血管壁的钉装置 - Google Patents

用于支持斑块贴靠血管壁的钉装置 Download PDF

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Publication number
CN104887365B
CN104887365B CN201510079624.1A CN201510079624A CN104887365B CN 104887365 B CN104887365 B CN 104887365B CN 201510079624 A CN201510079624 A CN 201510079624A CN 104887365 B CN104887365 B CN 104887365B
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spike devices
nail
patch
side ring
blood vessel
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CN104887365A (zh
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彼得·施奈德
罗伯特·贾索利
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Innovasc LLC
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Innovasc LLC
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    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract

一种用于支持斑块贴靠血管壁的钉装置形成为仅包括一对彼此共轴地间隔开的同心侧环，并且该对同心侧环中的每个同心侧环都具有用于在血管中递送的压缩状态和用于支持斑块贴靠血管壁的扩张状态；该装置还包括：连接该对同心侧环的多个纵向延伸的桥构件，其中，多个纵向延伸的桥构件中的每个桥构件在一端处连接至该对同心侧环中的一个同心侧环，并且在相对端处连接至该对同心侧环中的另一个同心侧环；以及位于每个桥构件上的一个或多个倒钩。该钉装置为临床医生提供进行最小侵入性的血管成形术后治疗并且在不使用支架的情况下产生类似支架的效果。

Description

用于支持斑块贴靠血管壁的钉装置
本申请是申请日为2010年6月11日、国家申请号为201080035222.7(PCT申请号为PCT/US2010/038379)、名称为“用于将斑块支持贴靠血管壁的最小表面积接触装置”的中国专利申请的分案申请。
技术领域
本发明涉及通过管腔内手术治疗动脉粥样硬化闭塞性疾病，所述管腔内手术用于推动和支持血管壁上积累的斑块使其不阻碍通道以重新打开血液流动。
背景技术
动脉粥样硬化闭塞性疾病是美国和工业化世界中的中风、心脏病发作、肢体缺损和死亡的主要原因。动脉粥样硬化斑块沿动脉壁形成硬层，并且其由钙、胆固醇、紧密的血栓和细胞碎片构成。随着动脉粥样硬化性疾病的进展，意图穿过特定血管的血液供应减少或者甚至被闭塞程序所阻止。临床治疗显著的动脉粥样硬化斑块的最广泛使用的方法之一是球囊血管成形术。
球囊血管成形术是在体内的每个血管床中打开阻塞或狭窄的血管的公认方法。球囊血管成形术使用球囊血管成形术导管实施。球囊血管成形术导管包括连接到导管的雪茄形圆柱球囊。球囊血管成形术导管从经皮或通过开放暴露的动脉建立的远程进入位点置入动脉中。所述导管沿血管内部穿过引导导管路径的线。导管的连接有球囊的部分设置在动脉粥样硬化斑块需要治疗的部位处。将球囊充气至与动脉在发展成闭塞性疾病之前的原直径相当的尺寸。当球囊充气时，斑块破裂。在斑块内形成解理面，这允许斑块直径随球囊膨胀而扩张。通常，部分斑块比其余的斑块更耐扩张。当这种情况发生时，泵入球囊的更大压力导致球囊充分膨胀至其预定尺寸。将球囊放气并移出，然后重新检验该动脉部分。球囊血管成形术过程是不受控制的斑块破裂的过程。治疗部位的血管腔通常略微扩大，但并不总是这样并且是不可靠的。
随着球囊血管成形术而破裂的斑块所产生的部分解理面形成夹层(dissection)。当部份斑块离开动脉并且不完全贴壁并且可移动或松散时，发生夹层。已被夹层破坏的斑块凸出进入流动流中。如果斑块在血流方向上完全翘起，则可能阻碍血流或导致急性血管闭塞。有证据表明，球囊血管成形术后的夹层必须进行处理以防止闭塞和解决残余狭窄。也有证据表明，在某些情况下，最好放置金属支护结构如支架，以在血管成形术后保持动脉打开，并且迫使夹层重新紧贴血管壁以创建充分的血流管腔。
因此，目前主要使用支架来进行球囊血管成形术后夹层的临床管理。如图24A所示，支架是直径相当于动脉尺寸的管。支架置入动脉中的夹层部位，以迫使夹层片紧贴血管内壁。支架通常由金属合金制成。他们有不同程度的柔性、可视性和不同的安置技术。支架放置在体内的各血管床中。支架的发展已经显著改变了微创治疗血管疾病的方法，使它更安全并且在许多情况下更耐用。使用支架显著降低了球囊血管成形术后急性闭塞的发病率。
然而，支架有重大缺点，正在进行许多研究和开发以解决这些问题。支架诱导经治疗的血管重复狭窄(复发性狭窄)。复发性狭窄是支架的“阿喀琉斯之踵”。取决于动脉的位置和大小，可能发生血管壁内膜增生组织在支柱之间或穿过支架开口向内生长，并且由于支架狭窄或闭塞导致血管重建失败。这可能发生在支架置入术后的任何时间。在许多情况下，支架本身似乎引起局部血管壁反应而导致狭窄，甚至是在最初的支架手术期间并不特别狭窄或患病的动脉部分上放置的部分支架中也是如此。这种针对存在支架的血管反应可能是由于支架的脚手架效应所致。这种复发性狭窄或血管组织生长是对支架的响应。这种活动表明如同使用支架所发生的那样，在动脉中广泛使用金属或血管覆盖有助于狭窄。复发性狭窄是一个问题，因为它导致支架失效和治疗无效。已经用于该问题的现有治疗方法包括：重复血管成形术、切割球囊血管成形术、低温血管成形术、粥样斑切除术(Atherectomy)以及甚至是重复支架术。这些方法都没有高度的长期成功率。
支架也可能由于材料应力而断裂。支架断裂可伴随慢性材料应力发生并且与支架断裂部位处的复发性狭窄的发展有关。这是相对较新的发现，可能对于每个血管床中的每个应用需要专门的支架设计。支架的结构完整性仍然是其应用的当前问题。显著移动的动脉如下肢动脉和颈总动脉特别受到关注。整个支架的完整性在血管弯曲或被压缩的任何时间、沿支架部分的任何部位进行测试。可能发生支架断裂的一个原因是对于较长的动脉段的治疗超出必要。支架的脚手架效应影响动脉的整体力学行为，使动脉的柔性下降。可得的支架材料具有有限的弯曲周期并且容易在反复高频弯曲部位处断裂。
许多动脉段即使不需要支架也被设置了支架，由此加剧了支架的缺点。这有几个原因。许多情况下，需要放置多于一个的支架并且经常需要数个。支架的大部分长度通常放置在不需要支架并且仅与夹层和病变区域相邻的动脉段上。针对病变区的精确长度进行调节的支架无法得到。当试图将多个支架置于最需要支架的部分中时，由于每个支架都需要安装和材料从而导致成本高昂。所需的时间也增加了成本和手术风险。容纳其并不需要的支架的动脉长度越长，则赋予动脉的刚性就越大，因此发生更多的脚手架效应。这也有助于引起动脉对于支架的反应，导致复发性狭窄。
发明内容
根据本发明，一种用于治疗动脉粥样硬化闭塞性疾病的钉装置(tack device)(和相关的配置方法)包括耐用柔性材料的环形带，其配置为在弹力或其它扩张力作用下可向外径向扩张并且在其外环周上具有多个病灶提升元件(focal elevating elements))。在贴靠血管壁的松散斑块的一个或多个特定位置处，在球囊成形术后通过导管递送机制将所述钉装置以压缩状态插入血管中并以扩张状态安装。病灶提升元件设计为在扩张压力下对斑块施加支持力，同时尽量减少与斑块或血管壁接触的材料表面积量。
斑块钉的环形带的血管壁轴(长度)方向宽度大约等于或小于其直径，以尽量减少血管中的外支架结构的放置。只在沿斑块积累部位长度的位置施加一个或多个钉，所述部位需要特定的支持力以稳定斑块和/或支持斑块碎片以不阻碍血液流动。钉的病灶提升元件可利用扩张力压入斑块和/或血管壁中，例如通过后安装球囊膨胀过程。
在本发明中，斑块钉装置设计作为一种微创方法，用以将松散或夹层的动脉粥样硬化斑块钉固在动脉壁上，如图24B所示。它可用于治疗全程动脉粥样硬化病变或球囊血管成形术的不足结果。其设计用于在经治疗的动脉中保持足够的管腔，而避免血管支架的固有缺点。该装置也可用于将药物、流体或其它治疗(“洗脱”)剂施用至动脉粥样硬化斑块或血管壁中或进入血液。
斑块钉和安装程序可以多种方式设计为共享共同的方法，即利用递送机构的扩张力(如球囊膨胀)和/或可压缩环形带的扩张力以使钉被移动到血管位置，然后在血管壁内释放、展开或解折叠以扩张至其全直径尺寸。
在一个优选实施方案中，所述钉装置包括耐用柔性材料的薄环形带，在其外环周上具有多个病灶提升元件，所述环形带的尺寸和设计适合利用压迫斑块的扩张力，以在所述带针对血管壁的施用部位处挤压和支持斑块。除了稳定所述钉的定位外，病灶提升元件的作用是将斑块钉固在血管壁中。所述环形带的血管壁轴向长度大约等于或小于其扩张时的直径。在环或带的形状中，环形带可具有1/100的长径比。斑块钉装置还可以具有载运药物的结构，使得其将生物活性剂洗脱至斑块中以抑制生长和/或治疗血管壁。
对于所有的实施方案而言，表征斑块钉设计的一个重要参数是血管覆盖面积(C)对总血管表面积(TVS)之比，其中C/TVS小于或等于约60％。该等式可以应用于一个钉装置或放置在血管治疗区的整个长度上的几个间隔钉装置。
在另一个优选实施方案中，钉装置形成为具有同心侧环或通过纵向桥构件连接的网带。为适应装置结构中的相对金属表面积(RMS)与纵向段数目的比较的量度，有效金属界面(EMI)方程可用于比较该钉装置的实施方案与典型的支架，如下：
其中x为金属段的数目，l为单个金属段的长度，w为单个金属段的宽度，C为装置下方的血管覆盖面积(腔表面)，并且n为纵向连接在周向取向段之间的桥构件的数目。分母中的求和可以解释为金属的总表面积。钉装置的该优选实施方案具有EMI≤10，而典型支架的EMI将大上数倍。
为了通过包括提升块(FEE)特征而进一步降低EMI，可得到针对钉有效金属界面的改进EMIF，如利用浮动元件所提供的(参见图27)。EMIF可以定义为：
其中所有变量与EMI方程中的变量相同，除了lF为不与动脉接触(浮离动脉)的金属段长度以及wF为同一段的宽度。如果不存在浮动段，则nF＝0，lFwF＝0，因此EMIF＝EMI。
本发明还包括使用该钉装置通过利用压靠斑块的扩张力安装该装置以支持斑块压靠血管壁来治疗球囊血管成形术后血管内的任何斑块夹层的方法。一个优选的方法包括其中首先进行药物洗脱球囊血管成形术，并且如果存在由于球囊血管成形术机构造成的对于血管的任何损伤、破裂、夹层或不规则，则可以使用一个或多个钉装置将受损、破坏、夹层或不规则的血管表面钉固，从而避免需要安装支架并由此保持“无支架”环境。
本发明的其他目的、特征和优点将在参考附图的以下详细说明中进行解释。
附图说明
图1A和1B是斑块钉装置的带状实施方案的示意图。
图2是展开后为环形的图1B的带钉的第一实施方案的侧视图。
图3是展开后为环形的图1B的带钉的正视图。
图4是具有稳定翼的图1B的带钉的替代方案。
图5是具有向外三角提升元件和向内径向指的弯曲星形钉的另一实施方案的示意图。
图6是具有未接合末端的螺旋线圈钉的另一实施方案的示意图，所述未接合末端可水平反向牵引以减少其插入血管的截面直径。
图7A-7D示出具有多种不同的提升元件设计的图5的弯曲星形钉的替代形状。
图8是图1B的带钉的照片图像，示出当钉弯曲成环形时以一定角度从金属带伸出的舌或开孔部分。
图9是图1B的带钉的提升元件的特写图像。
图10是图1B的带钉在安装前的照片图像。
图11示出在图1B的带钉的舌上形成的用于将斑块生长抑制材料递送至斑块中的毛细管图案。
图12是在图11的带钉的舌上形成的毛细管的特写图像。
图13是具有用于折叠的内V形段和用于锚定的外反转V形点的折叠环钉的另一实施方案的示意图。
图14是在用于插入血管中的导管的递送头上的多个单元中装载的带钉的示意图。
图15是图14中的带钉的递送头的详图。
图16是在导管的递送头上的多个单元中装载的具有将其以压缩形式保持在鞘上的固定器(保持器)的折叠环钉的示意图。
图17是示出部分展开的折叠环钉的示意图。
图18是示出在血管中完全展开的折叠环钉的示意图。
图19A以端视图示出金属网钉的第五实施方案，图19B以侧视图示出，图19C以透视图示出金属网钉，图19D以详图示出金属网钉的一部分。
图20是示出装载在导管递送管上的金属网钉的多个单元的示意图。
图21是示出从递送头释放并在血管中完全扩张的金属网钉的示意图。
图22是装载在鞘的递送头上的多个单元中并通过固定器盖固定的螺旋线圈钉的示意图。
图23是示出从递送头释放并在血管中完全扩张的螺旋线圈钉的示意图。
图24A示出如现有技术中常规实施的在血管成形术后安装的支架的使用。
图24B示出在血管成形术后安装的斑块钉的使用，表明其优于现有技术的优点。
图25示出形成有通过一系列桥接构件连接的同心环的斑块钉的另一实施方案的详图。
图26示出使用沿治疗部位的长度间隔开的多个钉装置与典型支架的对比。
图27是示出用于计算由于在斑块钉装置中使用病灶提升元件导致钉表面增加的变量的示意图。
图28示出使用具有病灶提升元件的钉装置将斑块位置支持在血管壁上。
图29A和29B示出在具有通过其间的桥连接的两个以上同心环段的钉装置上使用具有倒钩的病灶提升元件。
图30A和30B示出在具有两个以上同心环段的钉装置上的病灶提升元件的另一变化方案。
图31示出使用病灶提升元件将动脉壁重新塑形成所需截面形状。
图32-39示出在钉装置的支柱段上形成和定位病灶提升元件的变化。
图40A和40B示出形成有同心环的斑块钉的优选实施方案的详图，所述同心环包含在长支柱的顶端处的病灶提升元件和在桥上的倒钩组。
具体实施方式
本发明的主题涉及在其环周上具有病灶提升元件的环钉装置以尽量减少接触表面积并减少在钉装置和血管壁之间的接触区产生的摩擦。本发明的改进是用于在扩张力下支持松散斑块贴靠血管壁的在其环周上具有倒钩(barb)的环形钉装置的现有优选实施方案的原公开内容的部分继续。在下面的说明中，首先描述该现有优选实施方以说明具体实例及其实施细节。接着说明具有病灶提升元件的环形钉装置的改进的优选实施方案。
如图24B所示，现有斑块钉装置一般包括在其外环周上具有多个倒钩或锚定元件的耐用柔性材料的薄环带。径向调节斑块钉的尺寸并将其设计为对斑块施加扩张力以加压并支持其贴靠血管壁。所述倒钩或锚定元件通过斑块钉的扩张力嵌入斑块中或至少设置为与斑块物理接触。斑块钉仅延伸越过血管壁轴向的小区域，从而尽量减少放置在血管中的外来结构。一个或多个钉只沿斑块累积部位的长度施加，所述部位需要特定的支持力以稳定该部位和/或支持斑块的碎片使其不阻挡血流。
斑块钉和安装程序可以多种方式设计为共享共同的方法，即利用弹簧状环形带的外向力使得钉能够被压缩、折叠或堆叠为小直径体积，从而可以在鞘或导管上被移动到血管中的适当位置，然后在血管壁内释放、展开或解折叠以扩张至其全直径尺寸。
在以下说明中，详细说明斑块钉装置及其如何递送的五个一般实施方案，称为：(1)带钉；(2)折叠环钉；(3)柔性环钉；(4)螺旋线圈钉和(5)金属网钉。所有这些实施方案通过血管内插入递送至血管。各自的递送装置涉及具有血管鞘的一些特征的递送装置。每种斑块钉装置的递送装置各不相同并且具有专门设计用以递送特定钉的特征。
参考图1A和1B，斑块钉装置的第一优选实施方案显示为两种类型的带钉，分别具有如带一样的线型平面形状。图1A的类型具有基底端31、展开如尖锐倒钩或锚的开孔(cutout)舌或穿孔部分的行33以及固定器端35。图1B的类型具有基底端32、展开如尖锐倒钩或锚的开孔部分的单行34以及固定器端35。每个类型可由诸如耐腐蚀金属、聚合物、复合材料或其他耐用柔性材料的材料制成。优选的材料“形状记忆”金属(如Nitinol)，其允许初始形成具有环形，接着形成线型形状，然后在长时间暴露于身体内部温度时恢复环形形状。当所述带在血管中展开时，弯曲成环形形状。图2示出图1B的带材料在弯曲成其在血管中展开的优选形状后的视图，留下血液从中流过的大的内开放区域36。显示倒钩由于弯曲力开放为向外指向角度37，使得倒钩指向血管壁或血管表面。
在一个典型的配置中，带钉可具有约0.1至5毫米的宽度、约1至10毫米的直径(弯曲成环状时)、约3至30毫米的长度(当线性延伸时)以及0.01到5毫米的倒钩高度。一般来说，斑块钉的环形带的血管壁轴向宽度大约等于或小于其直径，以便尽量减少放置在血管中的外来结构的数量。对于环或带形的钉设计，支柱(strut)宽度与环直径之比可为1/10至1/100的范围内。
图3是示出弯曲成环形的带钉的上视图。图4示出具有沿侧边提供稳定翼用以在血管中展开时提供增加横向稳定性的替代方案。图8示出具有以向外角度伸出的锚的带钉的顶视照片图像。图9是环形带的锚的特写图像。图10是静止时线型延伸的金属带的顶视图。
图11示出可通过蚀刻舌或开孔部分的表面形成的毛细管25的图案，其用以递送斑块生长抑制物质或其它治疗剂，其中钉安装在斑块累积部位处。图12示出毛细管25的图案如何通过供应导管24供应斑块抑制物质或治疗物质。该物质可以停留在通道内，接着插入钉中或从环内侧上的储库通过表面上部件外侧的孔转移进入锚定物体中以及组织壁中，从而能够递送治疗剂或实现保持最优血流的附加预防性措施。使得物质能够从环内部通过树状分枝转移的力可以是毛细管力或毛细管力与液压压力的组合。毛细管作用、毛细现象、毛细运动或芯吸是物质吸引另一物质进入的能力。标准参照物是植物中的导管，但是用多孔纸也很容易观察到。其在液体与物质之间的粘合分子间力强于液体中的内聚分子间力时发生。该效应导致在物质接触垂直表面处形成凹月面。
使用倒钩或提升元件的阵列来连接钉的环形带与斑块物或血管壁。倒钩由足够刚性的材料制成以保持与血管组织的锁定关系和/或穿透斑块并维持其间的锁定关系。倒钩由设置在支撑体上的头部构成。优选地，头部和支撑体彼此形成为一体并构建成单片。倒钩可以90度角伸出与环带相切或者也可使用锐角。
参照图13，现有斑块钉装置的第二优选实施方案形成为折叠环钉，其具有与外反转V形点交替的用于折叠的内V形段。V形段允许环被径向折叠成小直径卷用以运载在鞘末端的展开管上。在血管的所需位置处，压缩环钉从展开管中释放，使得环弹出至其全直径形状并且向外的点用作嵌入或挤压斑块的倒钩或提升元件。折叠环钉优选由金属线材制成。对于外表面上的锚的形状可以使用其它选择。
参照图5，斑块钉装置的第三优选实施方案形成为柔性环钉，其具有可弯曲或铰接的结构并形成有在环外侧上径向延伸尖端59的阵列以及内径向指状物50的阵列。内径向指状物阵列用于移置尖端以沿一个轴向水平平放，此时所述指状物被沿相反的轴向推动。利用移置成水平平放的倒钩或尖端，该柔性环钉可以装载在导管递送管上并被外罩压制。然后移除所述指状物，使其在安装所述钉时无法阻挡血管。在所需位置处，移置固定器罩以释放环钉，其弹起以使其尖端径向向外延伸用以嵌入斑块中。环形环的主体可具有不同的厚度和不同设计的中央区域中的指状物，如升高的三角锚59和径向指状物50，如图5所示。
图7A-7D示出具有多种不同的锚固设计72、73、78、80的图5的第三实施方案的替代形状。用于弯曲插入点平(points flat)的指状物76、77被所有设计包括。当指状物在预装载后被移除并且柔性环钉已展开时，环形环79、82的内区74、75保持不被堵塞。
参照图6，现有斑块钉装置的第二优选实施方案形成为末端未接合并且在其外周上具有倒钩或点61的线圈形状64。所述末端被沿反向纵向牵引以使环带扁平成为线型延伸的螺旋形状，使得其可围绕管鞘长度或在管鞘长度内运送至血管中，通过固定器元件保持在合适位置。在血管内的所需位置处，释放固定器元件以允许钉扩张回其挤压斑块的全直径环形状。
图14和15示出上述带钉的优选递送方法。多个线型扁平带条80平行排列成携载在管状导管82的递送头81的外表面上的阵列80a。每个带条80携载在缠绕导管的多管钉匣84的对应管83中，如图14所示。导管具有内压腔85，其装有盐水溶液或二氧化碳气体，用于在其通过匣84沿方向RR旋转而移动使每个带条依次移至与递送头中的喷射器轨道86对准的喷射器位置(图中左侧)时，将带条从枪管中喷出。来自压力腔85的加压流体用于推动移动器构件以使带条从枪管喷射入喷射器轨道86。如图15中更详细所示，喷射器轨道86导致弯曲出口通道87，使得在递送头旋转时，带条向其环形状弯曲。出口通道87弯曲90度，从导管轴向至面向血管壁的径向。该弯曲通道捕获被推入喷射器轨道中的带末端并且导致带条的中部向外朝向血管壁突出，在此处它将放倒垂直于血管轴。导管的递送头作为递送机构的一部分旋转。当所述带在液压压力或推进压力下被推出递送头时，递送头的旋转允许所述带被放置成跨越血管壁的环形形状。
图16、17和18示出用于图13的折叠环钉的第二所述实施方案的优选递送方法。折叠环钉具有包括内V弯曲的整体圆形，允许将其以Z形方式折叠成压缩的较小体积形式，用以装载到导管92的递送端。如图16所示，压缩折叠环钉90的多个单元在导管表面上排列成串。导管是空心的并内衬有织物91，所述织物在导管外表面上滑动并且被牵引越过导管末端进入其内部(U形箭头方向)。所述织物由强韧耐用的低摩擦材料如聚四氟乙烯或芳纶纤维等材料制成。多个钉可装载到覆盖导管外表面的织物表面上。所述钉被外壳或外罩93压制成其压缩折叠形式，所述外壳或外罩93在导管上套叠并防止所述钉过早展开。外壳可以是透明塑料套或类似的结构，其末端从导管末端后置小段距离。当拉伸拉入导管内部的织物91时，被压缩的钉90朝向导管末端行进。当钉到达末端时，从外壳93中释放，并弹回其原始形状，即具有嵌入或放置贴靠斑块和血管壁的外倒钩的环形带。图17示出利用中途展开的钉工作的该过程。使钉90行进的织物91被拉入中空递送管的中心。图18示出从递送管分离出的置于血管中的钉。
图5的柔性环钉的第三优选实施方案可以用上述类似方法展开，即通过装载到在导管外表面上牵引的类似滑动织物载体，利用套在导管上的外壳防止所述钉展开，直至每个钉到达导管末端为止。
在图19A-D中示出金属网钉形式的现有斑块钉的第五实施方案，并且在图20和21中示出其展开方式。在图19A中，金属网钉以端视图示出，其具有由交错网格形成的环形带100a以及外尖端或倒钩100b。金属网钉可从金属管形式中激光切割或蚀刻出或由缠绕和交织成网的薄金属丝制成，所述金属丝焊接、钎焊、缠绕和/或连接在一起成为所需的网格形状。图19B以侧视图示出金属网钉，其具有从环形带100a伸出的倒钩。其外表面上的倒钩将接触并嵌入到血管壁。图19C以透视图示出处于完全展开状态的金属网钉，图19D以详图示出金属网钉的一部分。网格图案是特别设计的，以使其可以向内径向压缩至较小体积用以装载在待插入血管的导管递送装置上。
图20示出用于金属网钉的优选递送方法。多个网钉100被压缩至其较小体积尺寸并装载到导管递送管102的表面上，在给定长度的导管上形成阵列100x。如先前所述的递送方法，外罩或外壳103套在管表面上以保持所述钉处于其压缩状态并防止所述钉过早展开。当外罩103向下回撤管的长度时，每个网钉被依次释放并扩张至其全尺寸。图21示出在血管中扩张并展开的网钉100。
在图22和23中示出图6的螺旋线圈钉的第四所述实施方案的优选递送方法。图6中的线圈形钉形成有倒钩以及具有未接合末端的带，所述未接合末端可具有或可不具有厚度沿其长度变化的锥度。这种设计在静置状态下线圈展开，看起来像“破碎”的圆。线圈钉可以压缩到其静止直径的一部分，其方法是将线圈钉的末端沿相反线性方向拉伸以形成占据较小体积的紧密螺旋，使其可插入到血管中。当释放时，它可以扩大至其螺旋形状直径的数倍。图22示出装载在导管递送管112内部中的螺旋线圈钉110的多个单元。当所述钉被压缩时，它占据数个螺旋匝并且纵向间隔。在这种情况下，递送导管内衬有在其外表面上可滑动越过管末端至其外侧(由一对U形箭头指示)的织物113。当织物被牵引穿过管中心时，钉朝向递送导管末端行进。当钉到达递送导管末端时，所述钉被从管中释放并再次扩张至其全尺寸以展开进入血管壁中。图23示出在血管中展开的钉。
在前述现有实施方案中，优选斑块钉装置可由镍钛合金(Nitinol)、硅复合材料(有或没有惰性涂层)、聚乙醇酸或某些其它超弹性材料制成。锚可具有0.01毫米至5毫米的优选渗透长度。材料带可由通过光刻加工、激光或水切割、化学蚀刻或最终形状的机械移除或使用自下而上制造例如化学气相沉积工艺或使用注射成型、热压成型或使用电镀或化学镀加工的带、圆形或矩形线材或板材制成。它可由金属、塑料、陶瓷或复合材料制成。
斑块钉装置设计为是内在自对准，即其机械安装可调节小的失配。通过减少支柱构件中的应力，同时将动脉壁夹在设计中心处，使得所述钉与动脉纵轴自对准。提供应力消减和提供未折叠支柱均匀分布的设计特征包括窄间距的倒钩、不均匀的厚支柱以及倒钩头，其角度用以减少装置在递送过程中向前弹出。设置在每个桥构件上的周向取向的倒钩在靠在血管壁上时提供导管尖端和嵌入特征的夹持力。这些设计特征有助于将所述钉设置在病变血管的特定位置处。对于具有尖锐形状的穿刺倒钩而言，可用于嵌入在具有不规则表面的对象例如斑块或夹层或损伤的动脉表面中。在斑块钉展开后，外科医生可选择将球囊血管成形术的球囊放置在所述钉的部位处并将球囊充气以使一个或多个锚压入血管壁内。
斑块钉设计参数
本文所述的斑块钉不同于常规支架的目的在于将植入的外来材料量减至最低，同时还实施血管病症的病灶治疗以使血管壁反应和不良的治疗后再狭窄最小化。优选的斑块钉设计为具有显著较低的金属覆盖和/或与血管表面的接触，由此减少所引发的急性和慢性炎症。减少植入材料对血管壁的压力与较低的内膜增生发病率和更好的长期开放相关。显著减少沿血管轴向距离的长度允许更加靶向的治疗，与血管表面较少的异物体覆盖相关，避免覆盖表面不需覆盖的部分，并且与血管重建的早期和晚期的改善开放相关。斑块钉只在需要将已被球囊血管成形术或其它机制破坏的斑块钉固处展开。而不是覆盖整个治疗区域，斑块钉局部且选择性地放置，并且不延伸进入正常或较少病变的动脉段中。这允许血管保持其天然柔性，因为在局部使用小轮廓钉时或在甚至多个钉在治疗区域上间隔开时，脚手架效应最小或没有。减少压力曲线是通过使用“接触点”在病灶部位(位点)产生较高压力并且提升相邻支柱部分离开血管壁以减少在钉支柱结构上的其它位置的外向压力的总负荷。
斑块钉的一个设计参数为钉长度对直径比(L/D)约等于或小于1。亦即，沿血管轴的钉长度约等于或小于钉直径。优选的斑块钉因此形状如同环形环或带，而典型的支架的形状如同细长管。小轮廓钉因此可局部用于靶向治疗血管表面的破坏区域，同时外来材料覆盖或接触最小。我们的试验表明，与长度大于直径且通常长度远大于直径的常规支架相比，长度/直径比≤1的斑块钉几乎不导致生物反应或后续的血管狭窄。我们的试验表明，L/D≤1的装置产生的脚手架效应远低于典型支架并且较少引起血管壁反应。对于在球囊血管成形术后的小夹层部位处的应用而言，可使用具有最小覆盖区的斑块钉，例如L/D比为1/10至1/100的单一薄环形钉。
对支架的研究表明，支架长度与多个血管区中的闭塞趋势相关。已放置的支架长度越长，则重建失败的可能性就越高。支架长度也与置于浅股动脉中时支架的破裂频率和趋势直接相联系。医学文献指出，浅股动脉就像橡皮筋，并且浅股动脉的天然伸长和收缩的变化可能在浅股动脉支架的失效模式中具有重要作用。与此相反，在小轮廓斑块钉可仅在需要使用其的局部区域中植入，由此能够使血管保持其天然柔性以甚至在表面经历钉固后进行移动和弯曲。多个钉可区域分隔地植入而无需金属支撑，由此使动脉更自然地自由弯曲。
小轮廓斑块钉的设计也可以显著减少施加在血管壁上的向外径向压力，甚至在以间隔构型使用多个钉时也是如此。为了尽量减少这种向外的力，同时仍然提供夹层贴靠动脉壁的所需支持力，使用一系列的锚钩。对动脉壁施加病灶压力的倒钩的存在允许其余的钉对动脉壁施加最小的向外的力。施加压力的倒钩的尖端是非常针对病灶的，并且这是施加最大力的位置。所述钉施加的压力应用的病灶特性也最大限度地减少装置的结构影响。均匀分布的病灶提升元件提供使形成环形腔的倾向最大化的径向能量分布。
斑块钉的另一个重要设计参数是容器覆盖面积(C)对总血管表面积(TVS)之比。该等式可以应用到一个钉装置或在跨血管治疗区的长度放置几个间隔开的钉装置时。对于斑块钉而言，C/TVS比为约60％以下，而对于支架而言，它可以为100％以上(如果用于覆盖治疗部位)。对于病灶而言，常规治疗血管长度为X+10毫米至20毫米，其中X是病灶长度，增加的长度与病灶近端或远端的正常或较少病变动脉相邻。在常规支架术中，整个治疗血管长度将被支架覆盖。例如，在2厘米病灶的情况下，治疗血管长度为3至4厘米(通常选择该长度的单一支架)，使得C/TVS为150％-200％。与此相反，当放置钉时，约1/2的X将被覆盖，并且相邻的正常或较少病变的动脉不被治疗。例如，在2厘米病变中，约1厘米将被覆盖，使得C/TVS比为约60％以下。该创新方法的关键是仅在需要动脉钉固的夹层区中放置带。
在另一个优选实施方案中，钉装置形成有通过纵向桥构件连接的同心侧环或网带。图25示出在每一侧形成有通过一系列桥构件连接的同心环的斑块钉的优选实施方案的详图。在图中，同心侧环显示为被压缩用以在血管中递送。当扩张时，钉装置的直径大约等于钉装置的宽度。该实施方案可以从管或锥形管来激光切割，其中所述锥形管能够简化具有病灶提升元件的钉装置的生产。桥构件的数目的选择取决于应用。例如，在需要限制内膜增生时，在两个同心环之间可使用6个或更少的桥构件。
工业文献已指出，支架设计的一个重要因素可能是相对金属表面积(RMS)与装置结构中的纵向段的数目之比，例如Mosseri M,Rozenman Y,Mereuta A,Hasin Y,GotsmanM.,"New Indicator for Stent Covering Area",in Catheterization andCardiovascular Diagnosis,1998,v.445,pp.188-192所述。当采取RMS度量时，有效金属界面(EMI)方程可被用来比较具有纵向桥接构件的钉装置的实施方案与典型支架，如下：
成为：
其中x是金属段的数目，l是单个金属段的长度，w是单个金属段的宽度，C是装置下方的血管覆盖面积(腔表面)，并且n是纵向连接在周向取向段之间的桥构件的数目。包含浮动金属段(浮动长度lF，浮动宽度wF，浮动桥的数目nF)减少EMI，其进一步在数学上计算为EMIF方程中的负变量之和。在分母中求和可以解释为总金属表面积。具有纵向桥接构件的钉装置的实施方案具有EMI≤10，而典型支架的EMI将大几倍。这种低EMI的原因在于具有小覆盖区和最小纵向桥的钉设计的特性，而支架通常具有大的覆盖区并且将时其的好几倍。
图26示出使用多个钉装置，与典型支架相比，所述多个钉装置在相当于治疗部位的长度上间隔开。优选地，钉装置之间的间隔至少为钉装置的宽度。请注意，相邻钉装置之间的间距为未治疗的血管区。在图上部示出典型支架，与图下部中的使用6个间隔开的钉装置进行比较。治疗区的总长度是6.6厘米(相同长度的支架)，同时每个带显示为被6mm间距隔开的6mm长度。因此，支架的血管覆盖面积与总血管表面积(＝6.6cm×0.6π或12.44cm2)，得出C/TVS比为100％。对于一系列间隔开的钉装置而言，C等于6×0.6厘米×0.6π或6.78cm2，而TVS为12.44cm2，因此C/TVS比等于54.5％。
当需要在治疗部位的延伸长度上使用两个以上的支架时，常规实践是交叠相连的支架以防止支架之间的扭结。由于增加了金属格，因此在交叠区域变得高度刚性并且不顺应。这种不顺应限制天然动脉柔性并增加再狭窄的倾向。在多个支架展开并交叠时弯曲高频率发生并常见的浅股动脉中更频繁地发生支架断裂。支架断裂与支架内再狭窄和再闭塞的较高风险相关。与此相反，斑块钉设计为应用于局部区域并且不交叠。钉的最佳间距是最低1个钉的宽度间距。这允许动脉保持其柔性，并且只有一半或更少的动脉治疗长度将覆盖金属。
斑块钉外倒钩的存在通过将区域性向外的力转移至病灶压力点使得整体结构对血管壁的压力最小化，由此在病灶点处施加较高压力并且通过与血管壁接触的倒钩施加低压力。对动脉壁施加病灶压力的倒钩的存在允许其余的钉对动脉壁施加最小的向外力。无论倒钩放置在何处，在该区域中向外径向能量被最大化，导致动脉壁产生轻微的向外弯曲。向外弯曲可用于动脉成形或塑型，例如，可使用5个以上均匀分布的病灶点来形成循环腔。就血管壁相互作用而言，不考虑血管损伤，循环腔提供额外的益处。
药物洗脱球囊血管成形术后斑块钉的应用
使用斑块钉装置可以与使用药物洗脱球囊(DEB)血管成形术相结合以管理血管成形术后夹层以及避免需要支架。在DEB血管成形术中，以常规方式准备药物洗脱球囊或药物涂层球囊。所述药物可以是用于不同功能如抗血栓、抗有丝分裂、抗增殖、抗炎、促进愈合或其它功能的生物活性剂中的一种或组合。DEB在穿过血管系统中的堵塞或狭窄区的引导线上递送。根据用于治疗目的的制造指南，将DEB充气到特定压力并持续一段时间，因为它涉及药物涂层和预期效果，然后将DEB放气并移除。在这一阶段，药物已从DEB转移到血管壁。随后，利用血管内超声成像来评估球囊膨胀部位处的动脉完整性和血管表面的光滑性。沿表面的损伤可以表示为夹层、斑块抬高、组织破坏、表面不规则。斑块钉用于钉固受损的、破裂的、夹层的或不规则的血管表面。即使由于球囊血管成形术已经发生血管损伤，这也允许继续“无支架”环境。
在这一阶段，药物已从DEB转移到血管壁。在荧光显微引导下将造影剂施加至血管内或使用诸如血管内超声的另一方法来评估球囊膨胀部位处的动脉完整性和血管表面的光滑性。在某些情况下，一个或更多的这些完成的研究将表明沿表面的损伤存在于球囊膨胀部位处。这种损伤可包括夹层、斑块抬高、组织破坏、表面不规则。
斑块钉递送导管装载有多个钉，其可根据手术操作者的判断而放置并且在血管中的引导线之前到达发生夹层或破裂或不规则的部位处。利用血管造影术详细而小心地识别该部位。斑块钉在病变部位处展开。可放置多于一个钉以钉固主要的夹层。如果放置多于一个钉，则可只根据合适的钉间距规则来放置所述钉。即，钉应至少间隔一个钉长度并且不交叠。在放置所述钉后，其可以利用标准的血管成形术球囊或药物洗脱或药物涂层球囊进一步扩张进入血管壁。钉的目的不是使血管腔保持开放，而是钉固血管的不光滑或夹层的表面。这种“修补策略”允许解决药物洗脱或药物涂层球囊导致的损伤而无需求助于安置支架，由此保持“无支架”环境。
作为进一步的措施，如上所述，斑块钉装置本身可以用来递送药物至血管。除了从倒钩中递送药物外，所述钉可在钉安置之前涂覆有药物。该行动的目的是允许所述钉洗脱对于血管具有积极效果的一种或更多种生物活性剂。
病灶提升元件的改进
在本发明公开内容中，斑块钉装置可以通过扩大使用在所述装置的环周上的倒钩或病灶提升元件来进行改进。使用这种新的命名是为了区分用作锚或稳定器的作为具有更大的动脉壁穿透特征并且优选放置在连接环元件的支柱上的倒钩，而病灶提升元件是可以或不可以穿透但仍提供局部支柱抬高的特征，其优选放置在支柱的顶点上或周期性垂直于支柱长度。对于倒钩和病灶提升元件而言，钉与动脉壁之间的界面尺寸优选等于或短于至少一个方向上的支柱宽度。病灶提升元件与倒钩元件相似，但不穿透组织或仅轻微穿透组织，从而最大限度地减少与斑块接触的材料表面积量，并提供用于与病灶提升元件相邻的钉装置的向外压力的一系列释放段，从而最大限度地减少在血管壁上产生的摩擦。病灶提升元件以与前述钉装置实施方案类似的方式形成并配置在钉装置的环周上，包括在倒钩或尖头之外增加凸起的接触部分。所述接触部分可以提供改进的钉固特性，其中其通过在接触区压缩斑块来增加接触区的向外力，并且减少与病灶提升元件相邻区域处的向外力。这在某些区段提供局部压力释放并且在凸起或尖锐点处增加压力，从而共同提供血管壁的创伤和细胞反应的减少。
因为钉装置通过自身施加至血管表面上的压力而保持位置，所以其容易受到摩擦，即在装置和血管表面之间的轻微移动。每次器官移动(例如，行走时的腿)时，动脉也移动。可以推断，当动脉移动时，安置在动脉内的工作装置也移动，但不一定每一接触点均彼此同步移动。每当动脉与装置之间存在甚至微小失配时，该系统彼此摩擦从而促进细胞反应和装置失效。已从实验数据推导出这种摩擦刺激内皮细胞，引起炎症反应。在本发明中，进行病灶提升元件(FEE)的策略性放置以减少保持开放区域的整体摩擦负载(认为是炎症、细胞增殖和导致再狭窄的愈合反应的来源)。FEE产生的这些凸起部分通过限制装置与组织的接触来限制组织的组织学反应和装置的疲劳。与接触体积无关，钉装置使得腔壁光滑，并允许更多的天然血管运动。正是这种微观运动，增加血管表面对外来装置的细胞反应。
在钉装置的配置中，病灶提升元件设计为通过使与血管表面接触的总体材料最少化来减少有效金属界面(EMI)。病灶提升元件(FEE)优选配置为窄且抬高的特征，其具有足以穿透血管的高度并且将钉装置的相邻支柱段抬离以不再接触动脉壁，从而减少与动脉壁接触的异物表面积。减少接触负担在支柱构件连接外周环或周向取向的支柱带时特别有价值。与血管壁接触的支柱段可在其移动或摩擦血管壁时产生微摩擦。通过减少异物对血管壁的接触面积，减少产生微摩擦接触的趋势。
参照图27，示意图示出在斑块钉装置上使用病灶提升元件的优选设计假设。图中，h是指伸出血管的病灶提升元件的高度(注：锚入动脉或斑块体中的病灶提升元件的穿透深度不包括在这个计算中)，w是指病灶提升元件的宽度(在其基部)，并且IF是指抬离动脉壁的相邻支柱表面(数学简化为直线)。与病灶提升元件相邻的支柱可利用形状记忆材料制造或设计为对管腔直径变化提供补偿的压缩波。与病灶提升元件相邻的支柱力产生支柱的向外弯曲，其由意图扩张直至与血管壁接触的支柱的力所产生。IA是指不通过病灶提升元件与任何相邻的支柱结构接触的动脉壁的长度。
病灶提升元件可以形成为在钉装置的环周上的圆柱形、矩形、球形、锥形，泪滴形、锥体或倾斜的元件。它们可以通过将钉结构的一部分进行弯曲或冲压，通过附加工艺(例如通过在周边表面上焊接或退火)，通过消减工艺(例如通过研磨或蚀刻掉周围物质以使凸起元件高于周围表面)，或通过在片材或管材切割之前或之后修改周边表面的小部分使其高于周围表面来形成。例如，修改网钉结构的小部分的一种方法是通过线网的打结、扭转、弯曲或编织以产生从钉装置的与动脉壁连接的网表面上凸起的元件。
适当取向和对称定位的病灶提升元件可为病灶提供扩张力。当装置施加向外力并且动脉施加向内力时，病灶提升元件可以策略性地定位在减少与病灶提升元件相邻的支柱段的向外压力的位置上。
倒钩和病灶提升元件二者提供的战略优势包括：通过减少接触面积和将向外力转移至倒钩和病灶提升元件来减少钉支柱上的压力负担，使表面接触最小化，以减少动脉壁和钉支柱之间的微移动驱动的摩擦负载趋势，以及在倒钩和病灶提升元件穿透血管壁部分特征高度的部位处锚定所述钉的稳定性。
因为钉装置通过自身施加至斑块或血管表面上的向外力压力而保持位置，所以其容易受到摩擦，即在装置和血管表面之间的轻微移动。图28示出在钉的病灶提升元件和动脉壁之间的起作用的力。FT是钉装置对抗动脉壁力FA所施加的周向力。FFEE是由于设计和材料选择产生在在病灶提升元件处的附加周向力，并且FF是当动脉由于身体力而改变其取向或形状时产生的动脉摩擦力。每当身体部分移动时，血管也略微移动。病灶提升元件可以策略性地定位以减少可引起炎症、细胞增殖或导致再狭窄的身体反应的局部摩擦负载。
病灶提升元件的数量和位置会影响前述的总体相对金属表面积(RMS)。病灶提升元件可沿钉装置表面的长度定位，使得最小量的金属表面积量接触动脉壁。放置在周向支柱环之间的桥上或在钉装置的支柱段的顶点上的病灶提升元件可以减轻大多数的动脉损伤。当病灶提升元件仅放置在顶点和桥上时，由于窄长度，构成同心环的支柱构件的RMS略有改变，同时桥的RMS显著减少，从而减轻周向取向支柱环的相对移动。
图29A和29B示出使用根据图25的前述类型的在钉装置上的病灶提升元件，其具有其间通过桥连接的两个以上的环部分。图29A示出具有支柱部分290c并且在中间通过桥290d连接的两个相邻环部分290a和290b的单元。图29B示出在扩张力下扩张的环部分并且相反的病灶提升元件290e在两个相邻环部分290a和290b的相反端展开。该图的插图示出具有从支柱表面凸起的高度的圆形病灶提升元件。
图30A和30B示出在具有其间通过桥300d连接的两个以上的同心环部分300a、300b的钉装置上形成的病灶提升元件的另一变化方案的单元。在单元变化方案中，病灶提升元件300e通过将支柱(示为支柱顶点)伸出周向平面的部分弯曲至不同的倾斜角度来形成，例如位置“a”或位置“b”，位置“c”所示的至多90度的垂直取向以形成提升元件。
将形状记忆合金用于钉装置的内在特性是顺应血管壁形状的能力。由于病灶提升元件可以在损伤风险最小时的情况下对血管壁施加扩张压力，因此它们可以设计为将血管壁重新塑形为所需形状。图31示出定位在直径上的相反位置上的病灶提升元件(FEE)，其形成有延伸高度以将动脉壁重新塑形为椭圆形横截面形状，该形状可以更好地匹配动脉截面(如动脉分支)或扩大管腔以使无斑块区域更加开放。
图32示出沿支柱长度间隔开的FEE的侧视图，由于FEE的高度抬离相邻支柱长度的短距离导致其具有抬离动脉的小区域。所用设计和材料产生的向外力允许只有FEE另一侧的小部分被抬离血管壁。
图33示出沿钉装置的支柱部分长度间隔开的一系列FEE的透视图。
图34示出放置在钉装置的支柱部分的顶点上的圆柱形FEE的详图。
图35示出形成为在支柱部分的顶点上的锥体元件的FEE的透视图。
图36示出形成为在支柱部分的顶点上的圆顶元件的FEE的透视图。
图37示出通过弯曲支柱长度的一部分以将其高度提升至相邻支柱长度的表面上方而形成的FEE的透视图。
图38示出通过将支柱部分的顶点向上弯曲而形成的FEE的透视图。
图39示出通过将支柱部分(由丝线制成)扭曲而形成的FEE的透视图。
图40A和40B示出形成有在长支柱的顶点处包含病灶提升元件和在桥处包含倒钩组的同心环的斑块钉的优选实施方案的详图。
工业实用性
综上所述，本发明的钉装置用于在对动脉粥样硬化闭塞性疾病进行球囊血管成形术治疗后进行斑块保持，同时避免使用支架时由于在体内安装大量异物而可能造成损伤、炎症和/或提供再狭窄部位的问题。与此相反，所述钉装置最大限度地减少材料结构并且能够仅在需要保留的一个或多个斑块夹层部位处安装。在钉的周边上使用病灶提升元件的改进使得钉装置与血管壁的接触面积最小化并且减少导致斑块夹层或血管壁损伤的风险。这种方法为临床医生提供实施最小侵入性的血管成形术后治疗并且在不使用支架的情况下产生类似支架的结果。
应该理解，可以根据本发明原理的以上说明设想出许多修改和变化。所有这些修改和变化意图被视为在本发明的精神和范围，如以下权利要求书所限定。

Claims (10)

1.一种用于支持斑块贴靠血管壁的钉装置，包括：
仅一对同心侧环，所述一对同心侧环彼此共轴地间隔开，所述一对同心侧环中的每个同心侧环都具有用于在血管中递送的压缩状态和用于支持斑块贴靠血管壁的扩张状态；以及
多个纵向延伸的桥构件，所述多个纵向延伸的桥构件连接所述一对同心侧环，其中，所述多个纵向延伸的桥构件中的每个桥构件在一端处连接至所述一对同心侧环中的一个同心侧环，并且在相对端处连接至所述一对同心侧环中的另一个同心侧环；以及
位于每个所述桥构件上的倒钩组。
2.根据权利要求1所述的钉装置，其中，当扩张时，所述钉装置的直径大约等于所述钉装置的宽度。
3.根据权利要求1所述的钉装置，其中，当处于所述压缩状态时，所述一对同心侧环中的每个同心侧环都形成为Z字形。
4.根据权利要求1所述的钉装置，其中，每个同心侧环的宽度与直径之比为1/10至1/100。
5.根据权利要求1所述的钉装置，其中，所述钉装置由形状记忆合金制成。
6.根据权利要求5所述的钉装置，其中，所述形状记忆合金包括镍钛合金。
7.根据权利要求1所述的钉装置，其中，两个所述同心侧环之间具有6个或更少的桥构件。
8.根据权利要求1所述的钉装置，其中，所述钉装置不能自行扩张，并被构造为通过球囊膨胀挤压血管中的斑块来施用。
9.根据权利要求1所述的钉装置，其中，所述钉装置从管激光切割得到。
10.根据权利要求1所述的钉装置，其中，所述钉装置从锥形管激光切割得到。
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US10779971B2 (en) 2020-09-22
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US20140194967A1 (en) 2014-07-10
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