CN1301139A - 内腔脉管修复物 - Google Patents
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Abstract
本发明揭示了一种用于治疗、例如腹主动脉瘤的管状内腔脉管修复物(42)。该修复物(42)包括由挠性管状隔膜(44)所包围的自扩张线材支撑结构(46)。本发明还揭示了一种传送导管及其方法。
Description
发明背景
本发明涉及内腔脉管修复物(prosthesis),尤其涉及用于治疗腹主动脉瘤的自扩张内腔脉管修复物。
腹主动脉瘤是由于人体的一条主要动脉一主动脉在通过腹部时、其壁的异常扩张所引起的一种囊。腹部是人体介于胸与骨盆之间的那部分。它含有一内腔,俗称“腹腔”,该腹腔借助横膈膜与胸腔相隔开,并衬有一血清膜,俗称“腹膜”。主动脉是主干或动脉,全身的动脉系统均从该主动脉延伸出去。该主动脉自左心室上行,在转过一个弯之后又下行穿过胸、腹后到达大约第四腰椎的高度上,在那儿,该主动脉分成两条共髂动脉。
主动脉瘤通常出现在患病的主动脉的肾下部分中,例如,位于肾下方。如果不及时治疗,那么主动脉瘤最终会引起囊破裂而在极短的时间内导致致命的大出血。与破裂相关的高死亡率最初导致经腹壁的腹主动脉瘤外科修复。然而,涉及腹壁的外科手术是极其危险的。存在着相当高的死亡率和与大量的外科手术介入相关的死亡率,大体上包括用修复物装置来置换血管患病的主动脉瘤部分,该修复物装置一般系一种人造管或移植物,通常由聚酯、氨基甲酸乙酯、P、DACRONTEFLON或者其它适当材料制成。
要进行外科手术就要使主动脉从腹部切口中露出,该腹部切口可能从肋骨延伸至耻骨。必须堵塞位于主动脉瘤上方和下方的主动脉,这样才能切开主动脉瘤,并去除血栓或血液凝块以及动脉硬化碎屑。将来自主动脉后壁的小动脉分支结扎。将与正常主动脉同样大小的DACRO管或移植物缝合在位,从而置换主动脉瘤。于是,血液通过该移植物重新恢复流动。但必须在松开主动脉之前将肠子移回到腹后壁。
在腹主动脉瘤破裂之前进行外科手术而接受治疗的病人的生存率要明显高于主动脉瘤破裂之后进行手术的病人的生存率,但死亡率仍然相当得高。倘若在主动脉破裂之前进行外科手术,则死亡率一般略低于10%。传统的外科手术通常是在主动脉瘤破裂之后进行,一项研究显示该死亡率为66.5%。虽然腹主动脉瘤可通过常规检查查出,但病人不会体验到任何来自健康状况的痛楚。因此,倘若病人未接受常规检查的话,则主动脉瘤极可能会一直长到破裂为止,因而死亡率就相当得高。
除高死亡率之外,与传统的已有技术中的外科手术相关的缺点包括:此类外科手术的恢复期较长;难以将移植物或管缝合在主动脉上;会失去用于支撑和加固移植物的已有的主动脉壁和形成血栓;许多患有腹主动脉瘤的病人是不适合作外科手术的;以及,与在主动脉瘤破裂之后进行紧急手术相关的问题。病人可希望手术后在医院中待上一至两个星期,其中相当一部分时间需要特级护理,然后家里还需要两至三个月的逐渐康复期,尤其在病人还患有诸如心脏病、肺病、肝病和/或肾病的情况下,可能须要在医院待上更长的时间。因移植物必须固定或缝合在主动脉的其余部分上,故由于主动脉的其余部分上还存在血栓、且主动脉壁的其余部分常常发脆或容易破碎,因而经常难以进行缝合。
由于许多患有腹主动脉瘤的病人具有其它诸如心脏病、肺病、肝病和/或肾病之类的慢性疾病,再加上这些病人中的绝大部分都是老年患者,平均年龄接近67岁,因而这些病人绝不适合作这种大型的外科手术。
目前,已开发了一种称之为“内腔移植”的、用于主动脉瘤修复的、明显减少侵害的临床方法。Parodi等人提供了这种治疗方法的第一份临床记录。参见Parodi,J.C.等人的、“用于腹主动脉瘤的经股骨(transfemoral)官腔内移植物的移植术”一文,脉管手术5周年年鉴491(1991)。内腔移植包括将修复物动脉移植物经腔置换在内腔位置上(动脉内腔之中)。通过这种方法,移植物借助连接装置(可扩张斯滕特固定模(stent))连接在动脉壁的内表面上,通常一个位于主动脉瘤之上,而第二个则位于该主动脉瘤之下。
斯滕特固定模可使移植物固定在动脉壁的内表面上而无须进行缝合或开放式手术。可径向扩张的斯滕特固定模的扩张传统上是通过使一气囊在气囊式导管的远端处进行膨胀来实现的。例如,在美国专利4,776,337号(Palmaz)中揭示了一种用于内腔治疗的气囊膨胀式斯滕特固定模。美国专利4,655,771号(Wallsten)中也揭示了一种自膨胀式斯滕特固定模。
尽管以上已描述了一种斯滕特固定模,但仍然需要一种诸如用于横跨腹主动脉瘤的经腔移植的内腔修复物。较佳地,该管状修复物可在一位置上进行自扩张,以便治疗腹主动脉瘤。
发明概述
本发明的一个方面提供了一种内腔修复物。该内腔修复物包括具有一近端、一远端和从中延伸的一中心内腔的管状线材支撑结构。该线材支撑结构包括至少一第一和第二轴向相邻的管状分段,这些管状分段由延伸在两者之间的连接件相连。该第一和第二分段及连接件由单根线材制成。
在一实施例中,各分段中的线材包括一系列近侧弯部、一系列远侧弯部以及形成连接近侧弯部与远侧弯部以形成管状段壁的一系列壁(支杆(strut))段。较佳地,位于第一分段上的至少一个近侧弯部与位于第二分段上的至少一个相应的远侧弯部相连。这种连接可为金属连接件、接缝或者本技术领域中已知的其它连接手段。
较佳地,内腔修复物在其支撑结构上还具有诸如管状PTFE(聚四氟乙烯)套管之类的聚合层。
本发明的另一个方面提供了一种制造内腔修复物的方法。该方法包括:提供一段线材,并将该线材制成为两个或多个锯齿形部分,每一个锯齿形部分由交联件连接。然后,将该成形线材绕一轴线卷成一系列沿着轴线设置的管状件,以使每一个管状件通过连接件与相邻管状件相连。较佳地,该方法还包括:将管状聚合套管同心地定位在内腔修复物的至少一部分上。
本发明的又一个方面提供了一种多区域内腔修复物。该多区域内腔修复物包括具有一近端、一远端和从中延伸的一中心内腔的管状线材支撑结构。该线材支撑结构包括至少一第一和第二轴向相邻的管状分段,这些管状分段由延伸在两者之间的连接件连接。第一管状分段具有不同于第二管状分段的径向强度。在一实施例中,该修复物还包括第三管状分段。至少一个管状分段具有不同于其它两个管状分段的径向强度。在另一实施例中,修复物近端的直径可自扩张至大于修复物中心区的直径。
本发明还有一个方面提供了一种内腔修复物。该修复物包括一细长的挠性线材,该线材被制成为沿一轴线相隔设置的多个轴向相邻的管状分段。每一个管状分段包括一段锯齿形线材,该锯齿形部分具有多个近侧弯部和远侧弯部,其中该线材在各相邻管状分段之间是连续的,从而在装置的整个纵向长度上形成一种一体构造的支撑系统。该修复物可径向压缩成用于移植到体腔内的第一横截面减小的结构,并可在体腔的治疗位置上自扩张成第二横截面扩大的结构。
较佳地,该修复物还包括围绕修复物的至少一部分的外部管状套管。可通过该管状套管设置一个或多个侧向灌注口。
在一实施例中,修复物具有至少大约1∶5的扩张比,较佳地具有至少大约1∶6的扩张比。在另一实施例中,修复物在自由扩张时具有至少大约20毫米的扩张直径,并可利用不大于大约16弗伦奇(French)的导管进行移植。较佳地,修复物具有至少大约25毫米的扩张直径,并可借助其直径不大于大约16弗伦奇的传送装置进行移植。
本发明另外一个方面提供了一种移植内腔脉管修复物的方法。该方法包括:提供具有一近端、一远端和从中延伸的一中心内腔的一种可自扩张的内腔脉管修复物。该修复物可从第一减小的直径扩张至第二扩大的直径。将该修复物安装一导管上,以便当该修复物在导管上呈现直径减小的结构时,通过该修复物的导管直径不大于大约16弗伦奇。然后,将导管引入到体腔内,并将修复物定位在体腔内的治疗位置上。将该修复物在治疗位置上释放,以使其自第一直径扩张至第二直径,其中,第二直径为至少大约20毫米。
对于本技术领域中的那些熟练技术人员而言,通过结合附图和权利要求的本发明的描述,将对本发明进一步的特点和优点一目了然。
附图简介
图1是本发明一种内腔脉管修复物的示意图,该修复物定位在一对称的腹主动脉瘤之中。
图2是本发明内腔脉管修复物的分解图,它示出了自外套管分离出来的自扩张线材支撑结构。
图3是用于绕一轴线卷成本发明一种多段式支撑结构的成形线材的平面图。
图4是图3所示成形线材的一部分的放大图。
图5是沿着图4中的线5-5剖切的一种剖视图。
图6是沿着图4中的线5-5剖切的另一种剖视图。
图7是本发明另一种线材设计的局部视图。
图8是本发明一种交联线材设计的立面图。
图8A是用于形成图8所示交联实施例的成形线材设计的平面图。
图9是本发明又一种线材设计的局部视图。
图10是本发明再一种线材设计的局部视图。
图11是本发明一种顶端的局部视图。
图12是本发明另一种顶端的局部视图。
图13是本发明又一种顶端的局部视图。
图14是本发明还有一种线材设计的局部视图。
图15是本发明另有一种线材设计的局部视图。
图16是本发明又有一种线材设计的局部视图。
图17是本发明一种传送导管的示意图,该导管定位在一腹主动脉瘤之中。
图18与图17相类似,其中内腔修复物自传送导管局部展开。
图19是沿着图17中的线19-19剖切的剖视图。
图20是本发明一种锥形线材的局部视图。
图21是腹主动脉瘤的示意图,其中本发明的内腔脉管修复物分别定位在右肾动脉和右共髂骨之中。
较佳实施例的详述
请参阅图1,图中示出了腹主动脉及其主支脉的示意图。尤其,腹主动脉30表现为右肾动脉32和左肾动脉34。该主动脉较大的末端支脉是右左共髂动脉36和38。为简化起见,图中已省略了其它脉管(例如,第二腰动脉、睾丸动脉、下肠系膜动脉、中骶动脉)。一基本对称的主动脉瘤40如图所示位于患病的主动脉的肾下部分中。本发明的一种可扩张的内腔脉管修复物42,如图所示,横跨主动脉瘤40。虽然可改变本发明内腔脉管修复物的特征以用于例如共髂分支之类的分叉的主动脉瘤之中,但本文中将主要针对其在腹主动脉、或者胸或髂动脉的直段中的应用来描述本发明的内腔修复物。
内腔脉管修复物42包括一聚合套管44和一管状线材支撑结构46,如图1所示。在图2所示的分解图中可更清楚地看清套管44和线材支撑结构46。此处图示和描述的内腔修复物42示出了这样一种实施例:聚合套管44同心地位于管状线材支撑结构46的外部。然而,还可包括同心地位于线材支撑结构内部、或者同时位于该线材支撑结构的内部和外部的其它形式的实施例。或者,线材支撑结构可嵌置在形成套管的聚合基体之中。无论套管44是位于线材支撑结构46的内部还是外部,根据套管44的成分以及总的移植物设计,该套管可通过包括激光连接、粘接、夹紧、缝合、浸渍或喷镀等在内的多种方式中的任何一种方式来与线材支撑结构相连。
聚合套管44可由包括PTFE、PE(聚乙烯)、PET(对苯二甲酸乙二醇聚酯)、氨基甲酸乙酯、涤纶、尼龙、聚酯或纺织品在内的多种人造聚合材料及其组合中的任何一种制成。较佳地,该套管材料相对于线笼46的拟予放大的直径而言呈现出较低的固有弹性或者低弹性。该套管材料较佳地具有薄薄的轮廓剖面,例如不大于大约0.002英寸到0.005英寸。
在本发明的一较佳实施例中,套管44的材料是多孔的,足以使内皮细胞向内生长,从而更为牢固地锚定住修复物,并潜在地减小流动阻力、垂向力(sheerforce)以及修复物周围血液的泄漏。聚合套管材料中的多孔性可通过测量随流体静压而变化的渗水性来进行估算,该流体静压的范围较佳地从3至6psi(磅/平方英寸)。
聚合套管44的多孔特性可在修复物42的整个轴向长度上均一化、或者可顺着该修复物42的轴向位置发生变化。例如,请参阅图1和2,在使用中,顺着修复物42的不同的轴向位置上需要不同的物理性质。至少修复物42的近段部分55和远段部分59将抵靠在位于主动脉瘤近侧和远侧的当地脉管壁上。在这些近段及远段部分中,修复物较佳地鼓励内腔生长、或者至少允许内腔生长至修复物的渗透部分,以便于更好地锚定并将泄漏减至最小。修复物的中段部分57横跨主动脉瘤,从而锚定不再是一个问题。而,如何将流过修复物壁的血液减至最少俨然成了一个主要目标。因此,在修复物42的中段区57中,聚合套管44可呈无孔态、或具有不多于大约60%至80%的孔。
根据本发明,还可通过将一管状套管44设置在修复物的中段部分57上、以使该套管横跨将要治疗的主动脉瘤,但留下修复物42的近连接区55和远连接区59从线材支撑结构46中露出线材,从而设置一种具有多个区域的修复物42。在该实施例中,所露出的线材46同时与位于主动脉瘤近侧和远侧的脉管壁相接触,这样,随着时间的流逝,这部分线材会嵌入到生长在脉管壁的内表面上的细胞内。
在修复物42的一实施例中,套管44和/或线材支撑结构46呈锥形,它们在近端50处的扩张直径要大于远端52的扩张直径。这种锥形设计可使修复物更好地适应脉管自然递减的远侧横截面,从而减小移植物移动的危险,并潜在地形成更佳的流动态。
管状线材支撑结构46较佳地由一段连续的圆形(如图5所示)或扁平状(如图6所示)线材所制成。该线材支撑结构46较佳地形成在多个分离段54中,它们彼此相连且环绕一共轴定向。每一对相邻段54通过一连接部分66(下文中将作介绍)相连。这些连接部分66共同形成了一基本轴向延伸的支柱,该支柱增加了修复物42的轴向强度。诸相邻段可通过该支柱、以及包括沿圆周延伸的接缝56(如图1和2所示)、焊接部、线圈和多种呈互锁关系的结构中的任何一种在内的其它结构相连。接缝可由诸如尼龙、聚丙烯或不锈钢之类的多种生物聚合材料或合金中的任何一种制成。使分段54彼此固定的其它方式将在下文中加以介绍(参见图8)。
管状线材支撑结构46的分段构造具有极大的灵活性。虽然每一分段54与相邻段相连,但它还可独立制造以提供所需的参数。每一分段54的轴向长度的范围可从大约0.3至5厘米。一般而言,它们的长度越短,其径向强度就越强。一内腔修复物可包含大约1至50个分段,较佳地包括大约3至10个分段。例如,根据本发明,一较短的移植修复体可仅仅包括2个分段,并横跨总计2至3厘米,而一完整的移植物则可包括4个或更多的分段,并横跨整个主动脉瘤。除通过采用不同长度的分段所获得的灵活性及其它功能上的好处之外,通过调整与管状支撑结构相关联的线材弯部的数量、角度或结构可显得更为灵活。可能的弯曲结构将在下文中作详细介绍(参见图4-16)。
通过采用本发明多段式结构可获得多个附加优点。例如,请参阅图2,线笼46可被分割成近段区55、中段区57和远段区59。如上所述,该线笼46可被构造成自直径相对较大的近段区55向直径相对较小的远段区59逐渐减小。另外,线笼46可在一定区域内呈现过渡锥形和/或分级直径。
线笼46还可设有其扩张直径大于中段区57的近段区55和远段区59,如图2所示。这种结构可较理想地抵御修复物在脉管内移动。近段区55和/或远段区59可不为外覆物44所覆盖,而外部套管44仅仅覆盖在中段区57上。这样就可使近段区55和远段区59与位于病灶近侧和远侧上的组织直接接触,从而便于内腔细胞的生长。
除了在修复物42的不同区域内具有不同的扩张直径之外,还可在不同区域上施加诸如范围从大约0.2至0.8磅的不同的径向扩张力。在一实施例中,在近段区55上所施加的径向力要大于中段区57和/或远段区59上所施加的径向力。可以本文中其它地方所述的多种方式中的任何一种方式来施加较大的径向力,例如通过与位于中段区57或远段区59中的参考段54相比、采用附设的一个或两个或三个或多个近侧弯部60、远侧弯部62以及壁部64。或者,通过在近段区55中采用与修复物的其余部分数量相同、但用较大线经规格(gauge)线的近侧弯部60而可在该近段区中获得附加的弹簧力。通过绷紧图2中所示的接缝56、以使中段区57即使在扩张结构中也可保持在压缩状态下,从而可获得超出中段区57的扩张直径极限的径向力。通过忽略位于修复物的近端和/或远端处的接缝,该近端和远端将径向向外直至形成完全扩张的结构,如图2所示。
线材可由多种诸如埃尔基耐蚀游丝合金(elgiloy)、镍钛诺或MP35N之类不同的合金、或者包含镍、钛、钽或不锈钢、高Co-Cr合金的其它合金、或者其它温度敏感材料中的任何一种制成。例如,可采用一种含有15%的Ni、40%的Co、20%的Cr、7%的Mo以及配重Fe的合金。适用线材的拉伸强度通常在大约300Kpsi以上,对于多数实施例而言,则往往介于大约300到340Kpsi之间。在一实施例中,例如一种在市场上以名称为Coniehrom(Fort Wayne金属公司,印第安娜州)销售的铬-镍-钼合金具有范围从300至320Kpsi的拉伸强度、3.5-4.0%的延长度以及大约80到70lbs的断裂载荷。该线材可涂有一层浆层,并可设有或不设有诸如:PTFE、Teflon(聚四氟乙烯)、Perlyne(珀尔奈)和Drugs(德路格斯)之类的涂层。
除上述分段长度和弯曲结构之外,径向强度的另一个决定性因素为线材规格。在紧裹型轮廓的50%处所测得的径向强度的范围较佳地从大约0.2至0.8lb,一般是从0.4至0.5lb或以上。本发明线材直径的范围较佳地从大约0.004至0.020英寸。更佳地,该线材直径的范围从大约0.006至0.018英寸。一般来讲,线材直径越大,则用于一定线材设计的径向强度就越大。因此,线材规格可根据移植成品的应用场合结合/脱离其它设计参数中的变化(例如,每个分段的支杆、或者近侧弯部60和远侧弯部62的数量(下文中将作描述))而发生变化。在具有四个各长2.5厘米的分段的移植物中可采用直径约为0.018英寸的线材,其中每一分段具有用于使用在主动脉中的六个支杆,而具有诸如0.006英寸之类较小直径的线材则可使用在用于髂动脉的、每个分段具有5个支杆的0.5厘米长的分段移植物中。线笼42的长度可有28厘米之长。
在本发明的一实施例中,线材直径自近端至远端逐渐减小。或者,线材直径可针对各种临床应用所需的径向强度递增或逐级下降、或者逐级增大。在一实施例中,针对腹主动脉,线材在其近段区55中的横截面尺寸为大约0.018英寸,并且该线材逐渐减小至移植物42的远段区59中的大约0.006英寸的直径。在不脱离本发明精神实质的情况下,端点尺寸和缩减率根据所需的临床机能可大范围地进行变化。
请参阅图3,图中示出了用于绕一纵轴卷成一种四段式管状线材支撑结构的单根成形线材的平面图。该成形线材呈现出独特的分段,每一分段对应于管状支撑结构中的一个管状段54(参见图1和2)。
每一分段具有一种通过壁部64与相应的远侧弯部62相连的近侧弯部60的重复图形,当分段54径向扩张时,这种重复图形以基本锯齿形结构扩展。除移植物的末端之外,每一分段54通过连接部分66与相邻段54相连。图示实施例中的连接部分66包括将第一分段54上的近侧弯部60与第二相邻分段54上的远侧弯部62相连的两个壁部64。连接部分66还可设有一连接弯部68,它可用于将增大的径向强度传递给移植物,和/或提供一用于沿圆周延伸的接缝的连接地带。
请参阅图4,图中示出了线材支撑结构的放大图,其中在两个相邻段54之间设有一连接部分66。在图4所示的实施例中,近侧弯部60包括一段大约180度的弧形部分,该弧形部分具有径向直径(w)(范围从0.070至0.009英寸),它是由跟随其后的、横跨轴向距离d1的长度较短的平行线材的线材直径所决定的。接着,该平行线材又向下彼此叉开以形成支杆部分64、或者连接部分66的近侧半部。在支杆部分64的远端上,线材构成远侧弯部62,除反向凹入之外,该弯部较佳地具有与近侧弯部60相同的特征。介于相应的近侧弯部60与远侧弯部62的顶端之间的距离的轴向分量称之为(d),并表示该分段的轴向长度。由弯部60和叉开的支杆部分64所构成的总扩张角由α来表示。在压缩成紧裹状态的情况下,例如当移植物位于设置导管之中时,该角度α减小至α’。在扩张结构中,α通常落在大约35至45°的范围之中。介于任意两个相邻远侧弯部62(或者近侧弯部60)之间的扩张圆周距离被定义为(s)。
一般而言,各近侧弯部60或远侧弯部62的直径W落在大约0.009至0.070英寸的范围之中,这取决于线材直径。直径W相对于一定线材直径和线材特性而言较佳地应尽可能得小。但如本技术领域中的那些熟练技术人员所应意识到的是,当距离W减小至接近两倍于线材横截面尺寸时,弯部60或62将超出线材的弹性极限而将失去所形成的分段的径向强度。结合特殊线材直径和线材材料,通过本技术领域中的那些熟练技术人员所作的常规试验即可很容易地确定W的最小值。类似地,尽管从顶端到壁部64内的第一弯部至少要有某个距离d1,但该距离d1较佳地要减小到理想的径向强度性能要求的范围之中。当d1增加时,它可能会不利地增大移植物的紧裹型轮廓剖面。
从图3和4中可以清楚地意识到,在横切所形成的移植物的纵轴的一平面内的距离(s)总和将与该平面内的所形成的移植物的圆周相对应。对于一定圆周,近侧弯部60或远侧弯部62的数量直接关系到相应平面内的距离(s)。当应用于主动脉时,较佳地,位于任意一个横切平面内的所形成的移植物具有大约3至10个(s)尺寸,较佳地为大约4至8个(s)尺寸,且更佳地为大约5或6个(s)尺寸。各个(s)尺寸与介于任意两个相邻的弯部60-60或62-62之间的距离相对应,这从本文中的叙述中可一目了然。由此,每一分段54可被形象化成环绕移植物的轴线沿圆周延伸的一系列三角形,每一个三角形由一个近侧弯部60和两个远侧弯部62(或一个远侧弯部62和两个近侧弯部)来构成。
通过改变线材支撑结构的参数(例如,d,d1,s,α和α’),制造商对于轴向总长、轴向及径向灵活度、径向力和扩张比及由此带来的修复物性能可有极大的设计控制权。例如,由于紧裹型轮廓剖面的圆周可不小于一定横切平面内的距离(w)的总和,因此尺寸(w)的增加会直接导致紧裹型轮廓的增大。类似地,一定分段中近侧弯部60的数量的增加可能会增加径向强度,但同时也类似地增大了紧裹型轮廓剖面。由于主径向力来自于近侧弯部60和远侧弯部62,因此,壁部64起到用于将该力转化成径向强度的杠杆臂的作用。结果,减小用于一定数量的近侧弯部60的支杆部分64的长度将增加分段的径向强度,但要求其它的分段保持总的移植物长度。在需要最小的入口轮廓剖面的地方,径向强度最好通过减小壁部64的长度而不是增加近侧弯部60的数量来得以实现。另一方面,增加一定总长的移植物中(较短的)分段54的数量将在移植物径向扩张的同时增加其轴向缩短的量。因此,在需避免轴向缩短的一实施例中,通过选择线材材料或线材规格及其它参数、且同时将移植物内分段总数减至最少,可使增大的径向强度最优化。由于本文中所述的内容,本技术领域中的那些熟练技术人员应当对本发明其它几何形状的结果一目了然。
在图8A所示的一实施例中,对于0.018英寸的线材直径而言,w约为2.0mm±1mm。D1约为3mm±1mm,d约为20mm±1mm,c约为23mm±1mm,g约为17mm±1mm,a约为3mm±1mm,以及b约为3mm±1mm。由于本文中所述的内容,用于上述所有变量的特定尺寸可根据所需的线材结构进行显著地变化。
请参阅图7,图中示出了另一种具有多个位于一个或多个支杆部分64中的圆角弯部70的线材设计,这种设计增加了多个弯曲点,以便改善流体动态特性,并保持管状形状。
在线材支撑结构的另一实施例中,如图8所示,每一对相邻的近侧分段76和远侧分段78可通过相应的近侧弯部与远侧弯部的交联而连接。因此,来自远侧分段78的近侧弯部60与相应的近侧分段76的远侧弯部62相连,从而使近侧分段76与远侧分段78相联。由于本文中所述的内容,如本技术领域中的那些熟练技术人员所一目了然的是,可以多种方法中的任何一种来使相应的近侧弯部60与远侧弯部62相连。在图示实施例中,这种连接是通过采用连接件72来完成的。该连接件72可为诸如不锈钢之类的金属圈、焊接部或其它类型的连接。较佳地,连接件72包括可使近侧分段76相对远侧分段78枢轴转动的金属圈或环。
在本发明的一种内腔脉管修复物中,近侧分段76设有六个远侧弯部62。相应的远侧分段78则设有六个一一对应的近侧弯部60。在每一对相应的弯部60和62上可设有一连接件72,这样,在近侧分段76与远侧分段78之间的界面处横切移植物纵轴的一平面内就设有六个连接件72。或者,连接件72可少于所有对应的弯部,而只在每隔一个弯部、每三个弯部或者仅仅在移植物的相对两侧上设置连接件。可选择任意一所给实施例中连接件72的分布方式,以使一定设计中所需的灵活特性及其它性能标准最优化。
采用诸如交联件72之类的连接件能改善移植物绕脉管曲线部分时的踪迹随从。尤其,如图8所示的线笼46可绕一条平缓曲线弯曲,从而其既能保持其曲线形结构,又能保持通过其轴向延伸的中心内腔的开放。图2所示实施例可能更难以在保持中心内腔完全开放的同时随从曲线组织。在绕一条曲线延伸的同时保持完全开放的能力在某些人体组织中是较为理想的,例如在主动脉无法跟随图1所示的直线形肾下通道的情况下。
请参阅图8A,图中示出了用于绕一轴线卷成如图8所示的多段式支撑结构的一种成形线材的平面图。一般来讲,图8A所示的成形线材与图3所示的线材相似。然而,图3所示实施例中任何一对相应的远侧弯部62和近侧弯部60轴向叠置,以便于穿入一圆周接缝,而图8A所示实施例中相应的远侧弯部62和近侧弯部60彼此端对端毗连或彼此靠近,如图8所示,以便其上容纳一连接件72。
远侧弯部62相对一相应的近侧弯部60适当的轴向定位可以多种方式来得以实现,最方便地是通过在线笼的相邻段之间形成适当的连接弯部68。
图9-16示出了本发明其它弯部结构。图9示出了一种具有作为孔眼的近侧弯部和远侧弯部的实施例,但连接弯部68仍然保留为常见的结构。图10所示实施例具有呈孔眼结构的近侧弯部和远侧弯部以及连接弯部。图11-13中详细示出了本发明的各种孔眼设计,包括双圈型圆形孔眼(图11)、双圈型三角形孔眼(图12)以及单圈型三角形孔眼(图13)。这些孔眼可用于容纳上述沿圆周延伸的接缝或线材。
图14-16中示出了线材结构的其它实施例。图14示出了一种采用双弯部以增加弯曲度的近侧弯部60和远侧弯部62的实施例。或者,图15示出了具有更显著的长度(d1)的平行线材以及因此而变短的壁部64的三角形弯部。图16中示出了近侧弯部和远侧弯部的另一实施例,其中三角形弯部包含有采用壁段弯部70的形式的附加弯曲点。
请参阅图17和18,图中示出了本发明一较佳实施例的设置装置及方法。具有扩张尖端82的传送导管80顺着引导线前进,直到(在解剖学上)紧裹型内腔脉管修复物86的近端50定位在肾动脉32及34与主动脉瘤40之间。本发明紧裹型修复物的直径范围为2至10毫米。较佳地,该紧裹型修复物的直径范围为3至6毫米(12至18F)。更佳地,包含修复物的传送导管为16F、或者15F或14F或更小。
修复物86通过抑制管状传送导管80的壁而保持在其紧裹型结构中,去除这种抑制就可使修复物自扩张。可将不透射线的标记材料加入到传送导管80中和/或修复物68的至少其近端和远端处,以便于监视修复物位置。扩张尖端82与导管内心92相结合,如图18所示,其中当传送导管80的外鞘回缩时,显露出导管内心92和部分扩张的基体88。图19中还绘出了导管内心92的横截面图。
当外鞘回缩时,紧裹型修复物86关于导管内心92保持大致轴向固定,并因此在一预定的脉管位置上进行自扩张,如图18所示。外鞘的连续回缩使得移植物完全展开。展开后,已扩张的内腔脉管修复物的直径已自扩张至大约20至40毫米的范围之中,相应的扩张比为大约1∶2至1∶20。在一较佳实施例中,该扩张比的范围为大约1∶4至1∶8,更佳地为大约1∶4至1∶6。
除上述外鞘之外、或者取代该外鞘的是,修复物86可通过一限制带保持在其紧裹型结构中,该限制带编织在整个修复物上、或以紧裹的、减小的直径缠绕在修复物外部。在将修复物放置到治疗位置之后,可在近侧从修复物上收回该带子,从而释放该修复物而使它在治疗位置上自扩张。该带子可包括多种材料,例如缝线、PTFE带子、FEP(氟化乙丙烯)、聚酯纤维、以及对于有关本文内容的本领域的技术人员而言一目了然的其他材料。该限制带可在近侧延伸通过一传送导管的内腔或者该导管的外部延伸至一近侧控制件。该控制件可为一拉动片或环、可转动的卷轴、滑动开关或其它能够在近侧取回带子的结构。该带子可连续地延伸通过导管的整个长度,抑或连接于另一轴向移动件,例如一拉动线材上。
一般来讲,本发明移植物的扩张直径可为用于所需内腔或中空器官的任何直径,其中该移植物即将设置于上述内腔或中空器官之中。对于大多数的动脉脉管应用而言,扩张尺寸的范围约为10至40mm。腹主动脉应用通常其扩张直径约为20至28mm的移植物,例如,可在胸动脉中使用直径约为45mm的移植物。上述尺寸是指在不受约束的结构中、例如表(table)中的移植物的扩张尺寸。一般来讲,移植物将定位在其内截面略小于移植物的扩张尺寸的动脉之中。这样就能使移植物顶着动脉壁保持轻微的正压力,以有助于在聚合套管44的内皮愈合之前的这段时间内固留该移植物。
由修复物的近侧分段94顶着主动脉30的壁所施加的径向力提供了一防止脉管修复物周围的血液泄漏的密封,并可防止已展开的修复物轴向移动。如上所述,通过改变包括分段的轴向长度和弯曲结构在内的各种设计参数可按需改变径向力。在本发明的另一实施例中,如图20所示,通过改变线材规格可在近侧的上游端提高径向拉伸力。应注意到的是,线材规格沿着壁段64从近侧弯部60处的T1逐渐增加至远侧弯部62处的T2。因此,远侧弯部62所施加的径向挠曲要大于近侧弯部60所施加的径向挠曲,由此径向拉伸力在修复物的近端50处有所增加。T1的范围约为0.001至0.01英寸,而T2的范围则约为0.01至0.03英寸。
致使径向拉伸力自近侧分段至远侧分段逐渐减小的线材设计的另一实施例的整个线材支撑结构中的线材规格自近端处的大约0.01至0.03英寸逐渐或逐级减小至远端处的0.002至0.01英寸。此类实施例可用于形成锥形修复物。或者,线材规格在近端和远端处可较厚,以确保较大的径向拉伸力以及由此带来的密封性能。因此,例如,近侧和远侧分段中的线材规格约为0.01至0.03英寸,而中间段可构制成约为0.001至0.01英寸的较细的线材。
请参阅图21,图中示出了用于本发明内腔脉管修复物42的两个设置点。例如,一对称的动脉瘤33如图所示位于右肾动脉32之中。本发明的一扩张的内腔脉管修复物42如图所示横跨该动脉瘤33。类似地,一修复物42展开后横跨右共髂动脉瘤37。
请参阅图22,图中示出了本发明脉管内修复物96的一改型的实施例。在图22所示的实施例中,脉管内修复物96设有具有六个轴向对齐分段54的线笼46。然而,对于前述诸实施例,根据具体实施例的临床性能目标,脉管内修复物96可设有大约2至10个或更多的轴向分隔或相邻的分段54。
如上所述,线材支撑结构46设有一管状聚合套管。但在本实施例中,在该聚合套管44内设有一个或多个侧向灌注口或开口,例如如图所示,右肾动脉灌注口98和左肾动脉灌注口100。
在多种临床应用的脉管内修复物96的实施例中,聚合套管44中的灌注口是符合需要的。例如,尽管图1和22示出了一位于腹主动脉的肾下直段中的基本对称的动脉瘤40,该动脉瘤与两面对称的左右肾动脉和两面对称的左右髂骨轴向隔开,但该动脉瘤40的位置和对称性以及腹主动脉结构的构成对于不同的病人而言差别是很大的。因此,脉管内修复物96需要延伸穿过一根或两根肾动脉,以便充分地锚定脉管内修复物96并且/或者横跨动脉瘤40。设置一个或多个侧向灌注口可使脉管内修复物96横跨肾动脉,同时又能允许从中进行灌注,从而防止肾脏的“斯滕特固定膜监禁(jailing)”。倘若需要的话,还可提供通过脉管内修复物96的侧向灌注,以用于本领域的技术人员易于理解的、包括第二腰椎、睾丸、下方肠系膜、中部骶骨等在内的其它各种动脉。
脉管内修复物96还设有至少一个、较佳地两个或多个不透射线的标记,以便于在动脉内适当定位修复物96。在具有灌注口98和100的一实施例中,例如在图示的设计中,修复物96应当轴向且可转动地适当对齐,以便能同时观察该装置的轴向和转动位置。或者,只要传送导管的设计能进行足够的转矩传递,移植物的转动方向位置即可与位于导管近端上的索引标记相协调,这样通过转动方向位置的外部标记可转动和确定导管,以使其与左右肾动脉适当对齐。
在另一实施例中,聚合套管44延伸穿过动脉瘤40,但终止于肾下区。在该实施例中,修复物96上的一近段区55包括一线笼46,但不具有聚合套管44。在该实施例中,修复物96仍然实现了穿过肾动脉的锚定功能,而且从本质上不妨碍肾脏灌注。因此,根据未被覆盖的线笼46的所需长度,聚合套管44可覆盖修复物96的轴向长度的大约50%至100%,以用于例如锚定和/或侧向灌注。在具体实施例中,聚合套管44可覆盖大约70%至80%的范围,在具有单个暴露分段的一个四分段实施例中,聚合套管44覆盖修复物96的总长的75%。未被覆盖的线笼46仅仅位于修复物96的一个端部,以用于例如横跨肾动脉。或者,线笼46的暴露部分可设于修复物的两端,以用于例如锚定。
在另一实施例中,设有一个由两部分构成的聚合套管44。第一远侧部分横跨动脉瘤40,并具有终止于肾动脉末端的一近端。聚合套管44的第二近侧部分由位于肾动脉之上的线笼46的近侧部分所承载。这样就留下了通过脉管修复物96的侧壁的一环形侧向流动通道,它可与肾动脉轴向对齐而无须转动位置。
可根据肾动脉口预期的横截面尺寸、以及左右肾动脉之间潜在的轴向偏移来调节聚合套管44的近侧分段与远侧分段之间间隙的轴向长度。尽管右肾动脉32和左肾动脉34如图22所示同心地设置在腹主动脉的相对两侧上,但左右肾动脉从腹主动脉的分叉点(take off point)可顺着腹主动脉隔开设置,这对于本领域的技术人员是熟知的。一般来讲,对于典型的成年病人,以沿着腹主动脉的轴向方向所测得的肾动脉口的直径范围约为7至20cm。
本发明所满足的临床和设计的挑战包括:在脉管修复物的上游端和动脉壁之间提供足够的密封;提供足够的长度以横跨腹主动脉瘤;横跨动脉瘤的跨度提供足够的壁强度或支撑;以及提供充分的扩张比,因此可利用最小经皮轴向直径引导处于紧裹型结构中的脉管修复物。
已有技术中的方法目前采用一种7mm的插管器(18F),它包括手术过程,以便引入移植物传送装置。根据本发明,显著减小了插入管的轮廓。本发明诸实施例可被构制成具有16或15或14F或更小的尺寸(例如3-4mm),从而可通过经皮过程来设置本发明的内腔脉管修复物。此外,本发明的内腔脉管修复物无须柱气囊植入膨胀扩张术,而可被构制成在径向扩张的同时具有最小的轴向收缩,并可避免与镍钛诺移植物有关的缺点。
尽管已详尽描述了本发明的多个较佳实施例及其变型,但对本技术领域中的熟练技术人员而言,其它的变形和使用方法以及医疗应用将是显而易见的。因此,应理解到,只要不脱离本发明的精神和权利要求书的范围,可等同地进行各种应用、改型和替换。
Claims (34)
1.一种内腔修复物,包括:
具有一近端、一远端和从中延伸的一中心内腔的管状线材支撑结构;
所述线材支撑结构包括至少一第一和第二轴向相邻的管状分段,所述管状分段由延伸在两者之间的连接件相连;
其中,所述第一和第二分段及所述连接件由单根线材制成。
2.如权利要求1所述的内腔修复物,其特征在于,还包括至少三个分段和两个连接件。
3.如权利要求1所述的内腔修复物,其特征在于,还包括至少五个分段和四个连接件。
4.如权利要求1所述的内腔修复物,其特征在于,所述各分段中的线材包括一系列近侧弯部、一系列远侧弯部,并形成连接所述近侧弯部与远侧弯部、以形成管状段壁的一系列支杆段。
5.如权利要求4所述的内腔修复物,其特征在于,所述支杆段中的至少一部分大致呈直线形。
6.如权利要求4所述的内腔修复物,其特征在于,还包括位于所述弯部中的至少一部分上的孔眼。
7.如权利要求6所述的内腔修复物,其特征在于,位于所述第一管状分段的远端上的一个或多个孔眼与位于所述第二管状分段的近端上的相应的一个或多个孔眼相连。
8.如权利要求7所述的内腔修复物,其特征在于,所述相应的孔眼与接缝或环相连。
9.如权利要求4所述的内腔修复物,其特征在于,所述各分段包括大约4至12个近侧弯部。
10.如权利要求1所述的内腔修复物,其特征在于,具有至少一近侧分段、一中间分段和一远侧分段,其中所述修复物可自减小的横截面扩张至扩张后的横截面。
11.如权利要求10所述的内腔修复物,其特征在于,当所述修复物呈扩张后的横截面状态时,所述近侧分段和远侧分段的至少一部分的横截面要大于所述中间分段的横截面。
12.如权利要求1所述的内腔修复物,其特征在于,还包括位于所述线材支撑结构上的聚合层。
13.如权利要求12所述的内腔修复物,其特征在于,所述聚合层包括围绕所述修复物的至少一中心部分的管状PTFE套管。
14.一种制造内腔修复物的方法,包括下列步骤:
提供一段线材;
将所述线材制成为两个或多个锯齿形部分,每一个锯齿形部分由交联件隔开;
将所述成形线材绕一轴线卷成一系列沿着所述轴线设置的管状件,以使每一个管状件通过连接件与相邻管状件相连。
15.如权利要求14所述的方法,其特征在于,还包括下列步骤:将管状聚合套管同心地定位在所述至少一个管状件上。
16.如权利要求15所述的方法,其特征在于,所述定位步骤包括:将所述管状聚合套管同心地定位在所述管状件的外表面上。
17.如权利要求16所述的方法,其特征在于,所述管状聚合套管包括PTFE。
18.一种多区域内腔修复物,包括:
具有一近端、一远端和从中延伸的一中心内腔的管状线材支撑结构;
所述线材支撑结构包括至少一第一和第二轴向相邻的管状分段,所述管状分段由延伸在两者之间的连接件相连;
其中,所述第一管状分段具有不同于所述第二管状分段的径向强度。
19.如权利要求18所述的内腔修复物,其特征在于,还包括第三管状分段,其中所述至少一个管状分段具有不同于其它两个管状分段的径向强度。
20.如权利要求19所述的内腔修复物,其特征在于,所述修复物近端的直径可自扩张至大于所述修复物中心区的直径。
21.一种内腔修复物,包括一细长的挠性线材,所述线材制成为沿一轴线相隔设置的多个轴向相邻的管状分段,所述各管状分段包括一段锯齿形线材,所述锯齿形部分具有多个近侧弯部和远侧弯部,所述线材在所述各相邻的管状分段之间是连续的,其中,所述修复物可径向压缩成用于移植到体腔内的第一横截面减小的结构,并且可在体腔的治疗位置上自扩张成第二横截面扩大的结构。
22.如权利要求21所述的内腔修复物,其特征在于,包括至少三个由所述线材制成的分段。
23.如权利要求22所述的内腔修复物,其特征在于,还包括围绕所述修复物的至少一部分的外部管状套管。
24.如权利要求23所述的内腔修复物,其特征在于,所述套管还包括从中延伸的至少一个侧向灌注口。
25.如权利要求22所述的内腔修复物,其特征在于,所述修复物具有一近端和一远端,所述近端和远端中的至少一端在自由扩张时可扩张成其直径大于所述修复物中心部分的直径。
26.如权利要求21所述的内腔修复物,其特征在于,位于第一分段上的至少一个远侧弯部与来自相邻分段的至少一个近侧弯部相连。
27.如权利要求26所述的内腔修复物,其特征在于,所述连接包括可枢转的连接。
28.如权利要求27所述的内腔修复物,其特征在于,所述连接包括金属连接件。
29.如权利要求27所述的内腔修复物,其特征在于,所述连接包括接缝。
30.如权利要求21所述的内腔修复物,其特征在于,所述修复物具有至少大约1∶4的扩张比。
31.如权利要求30所述的内腔修复物,其特征在于,所述修复物具有至少大约1∶5的扩张比。
32.如权利要求21所述的内腔修复物,其特征在于,所述修复物在自由扩张时具有至少大约20-30毫米的扩张直径,并可利用不大于大约16弗伦奇的导管进行移植。
33.如权利要求32所述的内腔修复物,其特征在于,所述修复物具有至少大约25毫米的扩张直径,并可借助其直径不大于大约16弗伦奇的传送装置进行移植。
34.一种移植内腔脉管修复物的方法,包括下列步骤:
提供具有一近端、一远端和从中延伸的一中心内腔的一种可自扩张的内腔脉管修复物,所述修复物可从第一减小的直径扩张至第二扩大的直径;
将所述修复物安装一导管上,以便当该修复物在所述导管上呈直径减小的结构状态时,通过所述修复物的导管直径不大于大约16弗伦奇;
将所述导管引入到体腔内,并将修复物定位在所述体腔内的治疗位置上;
将所述修复物在所述治疗位置上释放,以使其自所述第一直径扩张至所述第二直径;
其中,所述第二直径为至少大约20毫米。
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US09/034,689 US6077296A (en) | 1998-03-04 | 1998-03-04 | Endoluminal vascular prosthesis |
US09/034,689 | 1998-03-04 |
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EP (1) | EP1059893B1 (zh) |
JP (1) | JP4143749B2 (zh) |
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CN (1) | CN1301139A (zh) |
AT (1) | ATE304330T1 (zh) |
AU (1) | AU7960098A (zh) |
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1998
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- 1998-06-15 JP JP2000534144A patent/JP4143749B2/ja not_active Expired - Fee Related
- 1998-06-15 AU AU79600/98A patent/AU7960098A/en not_active Abandoned
- 1998-06-15 AT AT98930137T patent/ATE304330T1/de not_active IP Right Cessation
- 1998-06-15 EP EP98930137A patent/EP1059893B1/en not_active Revoked
- 1998-06-15 KR KR1020007009800A patent/KR20010041603A/ko not_active Application Discontinuation
- 1998-06-15 CN CN98813843A patent/CN1301139A/zh active Pending
- 1998-06-15 RU RU2000123558/14A patent/RU2207826C2/ru not_active IP Right Cessation
- 1998-06-15 DE DE69831608T patent/DE69831608T2/de not_active Revoked
-
2000
- 2000-01-14 US US09/483,411 patent/US6331190B1/en not_active Expired - Fee Related
-
2001
- 2001-12-18 US US10/032,230 patent/US20020147492A1/en not_active Abandoned
-
2004
- 2004-01-12 US US10/755,703 patent/US20040204753A1/en not_active Abandoned
-
2006
- 2006-05-03 US US11/417,651 patent/US20060271163A1/en not_active Abandoned
-
2007
- 2007-01-16 US US11/623,679 patent/US20070112412A1/en not_active Abandoned
Cited By (5)
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CN105193530A (zh) * | 2015-11-13 | 2015-12-30 | 丛海波 | 带活动关节衔接模式的跨关节血管支架 |
CN110742709A (zh) * | 2016-03-18 | 2020-02-04 | 杭州唯强医疗科技有限公司 | 一种主动脉裸支架及主动脉夹层支架 |
CN110234297A (zh) * | 2017-02-01 | 2019-09-13 | 恩朵罗杰克斯股份有限公司 | 可纵向延伸的支架移植物系统和方法 |
CN114052820A (zh) * | 2021-11-30 | 2022-02-18 | 珠海通桥医疗科技有限公司 | 一种血管支架 |
CN114052820B (zh) * | 2021-11-30 | 2023-09-29 | 珠海通桥医疗科技有限公司 | 一种血管支架 |
Also Published As
Publication number | Publication date |
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US6331190B1 (en) | 2001-12-18 |
US6077296A (en) | 2000-06-20 |
WO1999044536A1 (en) | 1999-09-10 |
US20060271163A1 (en) | 2006-11-30 |
KR20010041603A (ko) | 2001-05-25 |
EP1059893B1 (en) | 2005-09-14 |
US20020147492A1 (en) | 2002-10-10 |
EP1059893A1 (en) | 2000-12-20 |
JP4143749B2 (ja) | 2008-09-03 |
US20040204753A1 (en) | 2004-10-14 |
EP1059893A4 (en) | 2001-11-21 |
ATE304330T1 (de) | 2005-09-15 |
JP2002505147A (ja) | 2002-02-19 |
AU7960098A (en) | 1999-09-20 |
DE69831608T2 (de) | 2006-02-02 |
US20070112412A1 (en) | 2007-05-17 |
DE69831608D1 (de) | 2005-10-20 |
RU2207826C2 (ru) | 2003-07-10 |
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