CN105796219A - 一种血管支架、其制备方法及应用 - Google Patents
一种血管支架、其制备方法及应用 Download PDFInfo
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Abstract
本发明涉及一种血管支架、其制备方法和应用,血管支架包括在定位区段、中央支撑区段和末端支撑区段,定位区段包括多个第一重复单体,中央支撑区段包括至少两个中央支撑单元和至少一个第一连接单元,中央支撑单元包括多个第二重复单体,末端支撑区段包括至少两个末端支撑单元和至少一个第二连接单元,末端支撑单元包括多个第三重复单体,第一重复单体的个数与第二重复单体的个数不同,中央支撑区段的支撑力大于末端支撑区段的支撑力,多个第一重复单体的前端部所形成的平面与血管支架的轴线相垂直。本发明的血管支架的支撑效果好,对静脉壁的伤害小,能够有效避免血栓的形成,定位效果好。
Description
技术领域
本发明属于医疗器械领域,具体涉及一种血管支架、其制备方法及应用。
背景技术
静脉疾病是血管外科疾病中最为常见的,尤其是下肢深静脉血栓及下肢大隐静脉曲张更为常见。而这两种疾病所形成的原因中有很大一部分是髂静脉受压所致。髂静脉受压综合征(iliacveincompressionsyndrome,IVCS)系指髂静脉被髂动脉压迫,导致腔内粘连、狭窄或闭塞,从而发生系列临床症状的综合征,又称May–Thurner、Cockett综合征。髂静脉受压综合征发生率在20%~34%。
在治疗上一直以手术来解决静脉受压,由于需要进腹手术,创伤较大,患者一直难以接受,因此在我国报道的手术例数较少。导致很多患者下肢肿胀无法解决,有部分患者因血液瘀滞出现静脉血栓。自上个世纪九十年代介入技术的发展,国内开始通过球囊扩张,支架置入术的方法来解决髂静脉受压,经过近20年的临床治疗,介入治疗的方法为血管外科界所接受,同时由于创伤小,患者也能接受,现在国内有很多医院已开展了这项工作。同时还有很多医师将该技术用于髂静脉血栓形成后遗症的患者。随着临床病例数的大幅增加,而目前临床一直使用口径较大的动脉支架来治疗髂静脉受压综合征的患者,从而出现了一个重要的问题,即支架内继发血栓的几率较高,这与动脉支架网孔小,以及髂静脉的结构导致动脉支架必须伸入下腔静脉1-1.5厘米,且其支撑力不是为静脉所设计而导致的。
目前,国内外众多的研究报道显示,以髂静脉受压综合征为适应症而设计的支架较少。国内有可取出自膨式骼静脉支架(实用新型:201520126120.6)有效预防下肢深静脉血栓脱落造成的肺栓塞,在完成治疗目的后,可经颈静脉或股静脉途径取出避免支架长期留置产生并发症。用于治疗髂静脉狭窄的支架(实用新型:201320053442.3)由镍钛金属丝编织绕成的网格状网管,网管前端管口面为斜面,斜面与网管断面的夹角为40度,网管上有椭圆形的标记圈,实现定位准确。但是这些骼静脉支架仍然存在一些问题:都不适用于恢复骼静脉血流状态和增加血流量,并且容易导致血栓的形成,因而有必要开展新型骼静脉支架的研发及应用研究。
发明内容
本发明所要解决的技术问题是克服现有技术的不足,提供一种结构不同的血管支架、其制备方法及应用,该血管支架具有不容易形成血栓,组织相容性好,对静脉的支撑力适当且不影响血流,结构简单,操作方便,定位准确,能够满足临床中对髂静脉治疗的需要。
为解决以上技术问题,本发明采用如下技术方案:
本发明的一个目的是提供一种血管支架,其能够从具有第一横截面直径的压缩状态变化到具有被扩大了的第二横截面直径的扩张状态,
所述的血管支架包括在所述的血管支架的轴线方向上依次连接的定位区段、中央支撑区段和末端支撑区段,
所述的定位区段包括沿着所述的血管支架的周向分布的多个第一重复单体,
所述的中央支撑区段包括在所述的血管支架的轴线方向上彼此相接的至少两个中央支撑单元和至少一个第一连接单元,所述的中央支撑单元包括沿着所述的血管支架的周向分布的多个第二重复单体,
所述的末端支撑区段包括在所述的血管支架的轴线方向上彼此相接的至少两个末端支撑单元和至少一个第二连接单元,所述的末端支撑单元包括沿着所述的血管支架的周向分布的多个第三重复单体,
所述的第一重复单体的个数与所述的第二重复单体的个数不同,所述的中央支撑区段的支撑力大于所述的末端支撑区段的支撑力,多个所述的第一重复单体的前端部所形成的平面与所述的血管支架的轴线相垂直。
根据本发明的一个实施方式,所述的第一重复单体的个数小于所述的第二重复单体的个数。
优选地,所述的第二重复单体的个数为所述的第一重复单体的个数的2~4倍,所述的第一重复单体的个数为4至10个。
进一步地,所述的中央支撑区段的前端部连接有第一显影单元。
根据本发明的一个优选方面,所述的中央支撑区段的第二重复单体的前端部连接有第一显影单元,第一显影单元的个数与所述的第一重复单体的个数可以相等也可以不等。
本发明中,第一重复单体可以与第二重复单体相连接,也可以与第一连接单元相连接。
根据本发明的一个实施方式,所述的定位区段的延伸方向与所述的血管支架的轴线方向的夹角为0°~60°。
优选地,当所述的定位区段的延伸方向与所述的血管支架的轴线方向的夹角为0°时,所述的血管支架大致呈圆柱体;当所述的定位区段的延伸方向与所述的血管支架的轴线方向具有夹角时,所述的定位区段自与所述的中央支撑区段相连接的一端部向着前端部逐渐向着远离所述的血管支架的轴线的方向延伸。
根据本发明的一个优选方面,所述的第一重复单体的前端部为圆角,圆角的圆弧内侧半径大于等于0.1mm。
根据本发明的一个实施方式,所述的第一重复单体的长度为5~15mm,优选为10~15mm;所述的中央支撑区段和所述的末端支撑区段的长度独立地为30~60mm,优选为30~40mm;所述的血管支架的厚度为0.1~0.3mm。
根据本发明的一个实施方式,所述的第二重复单体和所述的第三重复单体的长度独立地为1~7mm,优选为2~5mm。
优选地,所述的末端支撑区段的后端部连接有多个第二显影单元。更为优选地,所述的第二显影单元的个数为3至10个。
根据本发明的一个具体实施方式,所述的第一连接单元包括沿着所述的血管支架的周向分布的多个第一连接体,所述的第二连接单元包括沿着所述的血管支架的周向分布的多个第二连接体,所述的第一连接体的个数不多于所述的第二重复单体的个数,所述的第二连接体的个数不多于所述的第三重复单体的个数,所述的第二重复单体的个数与第三重复单体的个数相等。
更为优选地,每个所述的中央支撑单元中的所述的第二重复单体的个数为每个所述的第一连接单元中的所述的第一连接体个数的2~3倍。
更为优选地,每个所述的末端支撑单元中的所述的第三重复单体的个数为每个所述的第二连接单元中的所述的第二连接体个数的2~3倍。
本发明中,所述的中央支撑区段与所述的末端支撑区段可以通过第一连接单元与末端支撑单元相连接,也可以采用中央支撑单元与第二连接单元相连。
优选地,所述的第一连接体的宽度比所述的第二连接体的宽度宽10%~30%,所述的第二连接体的宽度为0.1~0.3mm。
本发明中,所述的第一连接体的宽度与所述的第一重复单体的宽度相等。
本发明中,所述的第二重复单体的宽度和所述的第三重复单体的宽度可采用常规宽度,如0.1~0.3mm。本发明中,所述的血管支架的材质为不锈钢、记忆合金、钛合金、钽合金、钴铬合金、生物可降解金属、生物可降解聚合物、镁合金、纯铁中的一种或多种。
本发明的另一个目的是提供一种上述血管支架的制备方法,将材料按照支架设计图纸上的路径进行激光切割,然后经酸洗、电化学工艺处理得到所述的血管支架。
当然,本发明的血管支架也可以采用其他方法进行制备,例如,编织或焊接。
本发明的第三个目的是提供一种支架输送系统,其包括上述血管支架。
本发明的第四个目的是提供一种上述血管支架在分叉血管中的用途。
优选地,本发明提供一种上述血管支架在髂静脉中的用途。
本发明中以定位区段所在侧定义为血管支架的前方,以末端支撑区段所在侧定义为血管支架的后方。
本发明中定义的夹角为直线与平面或者直线与直线之间形成的小于90°的角。
本发明中的血管支架的总长度是指第一重复单体的前端部至第二显影单元的最长垂直距离。第一重复单体、第二重复单体和第三重复单体的长度是指每个重复单体的前端部至后端部的垂直距离。中央支撑区段是指第一显影单元至末端支撑区段的前端部之间的垂直距离。末端支撑区段的长度是指中央支撑区段的后端部至第二显影单元之间的垂直距离。
由于上述技术方案的实施,本发明与现有技术相比具有如下优点:
本发明的血管支架特别适用于髂静脉,对髂静脉的支撑效果好,且对静脉壁的伤害小,能够有效避免血管支架植入后支架内继发血栓的形成,此外,本发明的血管支架能够很好的在髂静脉中进行定位,提高了释放的准确性,操作简便,本发明的血管支架的结构简单,生产方便,成本低,从而具有重要的现实意义和良好的临床应用前景。
附图说明
图1为实施例1的血管支架植入于髂静脉中的示意图(定位区段的延伸方向与血管支架的轴线方向一致);
图2为实施例1的血管支架展开成平面的结构示意图;
图3为实施例1的血管支架在扩张状态的立体图(定位区段的延伸方向与血管支架的轴线方向一致);
图4为实施例1的血管支架在扩张状态的立体图(定位区段呈喇叭口形状);
图5为第二连接体的放大图;
图6为第一连接体的放大图;
图7为第一重复单体的放大图;
图8为实施例2的血管支架展开成平面的结构示意图;
图9为实施例2的血管支架在扩张状态的立体图(定位区段的延伸方向与血管支架的轴线方向一致);
图10为实施例2的血管支架在扩张状态的立体图(定位区段呈喇叭口形状);
图11为实施例1的血管支架植入于髂静脉中的示意图(定位区段呈喇叭口形状);
图12为实施例2的血管支架植入于髂静脉中的示意图(定位区段的延伸方向与血管支架的轴线方向一致);
图13为实施例2的血管支架植入于髂静脉中的示意图(定位区段呈喇叭口形状);
其中:1、定位区段;11、第一重复单体;2、中央支撑区段;21、中央支撑单元;211、第二重复单体;22、第一连接单元;221、第一连接体;3、末端支撑区段;31、末端支撑单元;311、第三重复单体;32、第二连接单元;321、第二连接体;4、第一显影单元;5、第二显影单元;β为第一重复单体的前端部所形成的平面与血管支架的轴线的夹角;W1为第一连接体的宽度;W2为第二连接体的宽度;W3为第一重复单体的宽度;W4为第二重复单体的宽度;W5为第三重复单体的宽度;L1为第一重复单体的长度;L2为中央支撑区段的长度;L3为末端支撑区段的长度;L4为第二重复单体的长度;L5为第三重复单体的长度;L6为血管支架在扩张状态时的总长度。
具体实施方式
下面结合具体实施例对本发明做进一步详细的说明,但本发明并不限于以下实施例。
本发明的血管支架主要适用于分叉血管中,特别适用于髂静脉中(如图1)。在将血管支架植入髂静脉的过程中,血管支架安装在支架输送系统的输送器中,此时,血管支架处于压缩状态,当输送器将血管支架输送至合适位置后,释放血管支架,血管支架向外扩张至扩张状态,从而对髂静脉起到支撑作用,血管支架在压缩状态时具有第一横截面,在扩张状态状态时具有第二横截面,并且,第一横截面的直径小于第二横截面的直径。本发明中,第一横截面和第二横截面为中央支撑区段2的横截面,且该横截面与血管支架的轴线相垂直。本实施例中,第二横截面的外径为10~20mm,优选为12~16mm。
血管支架的材质为不锈钢、记忆合金、钛合金、钽合金、钴铬合金、生物可降解金属、生物可降解聚合物、镁合金、纯铁中的一种或多种。不锈钢可采用SUS-316L不锈钢等。记忆合金可采用Ni-Ti合金、Cu-Al-Mn合金等。钴铬合金可采用CoCr-L605钴铬合金等。生物可降解金属是一种可在人体内分解的金属,例如纯镁、镁合金、纯铁和铁合金等。生物可降解聚合物可以是聚乳酸、聚乙醇酸、聚(乳酸-ε-己内酯),聚(乙醇酸-ε-己内酯)等生物可降解的聚合物。此外,也可在体内可降解金属上,涂上一种生物可降解聚合物材料来作为血管支架的材料。
本发明的血管支架可以利用激光雕刻一次成型。激光雕刻的生产过程:首先,基于支架设计图纸利用CAM创建切割路径;其次,对金属或高分子材料进行激光切割;最后,经过酸洗和电化学工艺提高表面光洁度,使各边缘形状圆润。
如图2和图3所示,血管支架包括在血管支架的轴线方向上自前向后依次连接的定位区段1、中央支撑区段2和末端支撑区段3。
定位区段1包括沿着血管支架的周向分布的多个第一重复单体11。
中央支撑区段2包括在血管支架的轴线方向上彼此相接的至少两个中央支撑单元21和至少一个第一连接单元22,中央支撑单元21包括沿着血管支架的周向分布的多个第二重复单体211,第一连接单元22包括沿着血管支架的周向分布的多个第一连接体221。第一连接体221的个数不多于第二重复单体211的个数,优选地,每个中央支撑单元21中的第二重复单体211的个数为每个第一连接单元22中的第一连接体221个数的2~3倍。
末端支撑区段3包括在血管支架的轴线方向上彼此相接的至少两个末端支撑单元31和至少一个第二连接单元32,末端支撑单元31包括沿着血管支架的周向分布的多个第三重复单体311,第二连接单元32包括沿着血管支架的周向分布的多个第二连接体321。第二连接体321的个数不多于第三重复单体311的个数,优选地,每个末端支撑单元31中的第三重复单体311的个数为每个第二连接单元32中的第二连接体321个数的2~3倍。
本发明中的第一重复单体11、第二重复单体211、第三重复单体311的结构可以是能够形成孔的任意形状,例如V型、网格型、菱形等。第一连接体221和第二连接体321在整个血管支架上的分布方式可以是任意的,例如直线形式、V型、W型、S型、N型等。
本发明中,中央支撑区段2的前端部连接有第一显影单元4,本实施例中,中央支撑区段2的第二重复单体211的前端部连接有第一显影单元4,第一显影单元4的设置使得血管支架能够很好的实现定位,方便医生找准释放点。
本实施例中,第一重复单体11的后端部与第二重复单体211的前端部相连接。
本发明中,第一重复单体11的个数为4至10个,第一显影单元4的个数与第一重复单体11的个数相等或不等。
本发明中,中央支撑区段2与末端支撑区段3可以通过第一连接单元22与末端支撑单元31相连接,也可以采用中央支撑单元21与第二连接单元32相连接,即,中央支撑区段2与末端支撑区段3之间的连接体可以是第一连接体221,也可以是第二连接体321。当中央支撑区段2与末端支撑区段3之间的连接体是第一连接体221时,中央支撑单元21和第一连接单元22的个数相同。
本发明中,末端支撑区段3的后端部连接有多个第二显影单元5,第二显影单元5的个数为3至10个,并且,第二显影单元5的个数与第一显影单元4的个数相等。本实施例中,第二显影单元5可以与末端支撑单元31相连接,或者与第二连接单元32相连接,第二显影单元5沿着血管支架的周向均匀分布。
本发明中,第一重复单体11的个数与第二重复单体211的个数不同,第二重复单体211的个数与第三重复单体311的个数相等。优选地,第一重复单体11的个数小于第二重复单体211的个数,本实施例中,第二重复单体211的个数为第一重复单体11的个数的2~4倍,从而保证第一重复单体11形成的孔径较大,如图1所示将血管支架植入髂静脉后,定位区段1伸至下腔静脉时,能够避免因血管支架的孔径较小到导致血栓的形成以及避免定位区段1对对面髂静脉的血流造成影响。
本实施例中,定位区段1的延伸方向与血管支架的轴线方向的夹角为0°~60°。如图3所示,定位区段1的延伸方向与血管支架的轴线方向一致,即夹角为0°,此时,血管支架在扩张状态时大致呈圆柱体型。如图4所示,定位区段1的延伸方向与血管支架的轴线方向存在夹角,并且,定位区段1自与中央支撑区段2相连接的一端部向着前端部逐渐向着远离血管支架的轴线的方向延伸,即定位区段1呈自后向前逐渐向外扩张的喇叭口形状。
本发明中,中央支撑区段2的支撑力大于末端支撑区段3的支撑力,保证了血管支架的中央支撑区段2对髂静脉的支撑力的同时降低了血管支架的末端支撑区段3对静脉壁的损伤。本发明中采用第一连接体221的宽度W1比第二连接体321的宽度W2宽10%~30%来实现中央支撑区段2的支撑力大于末端支撑区段3的支撑力,当然,也可以采用其他方式来实现中央支撑区段2的支撑力大于末端支撑区段3的支撑力。本实施例中,第二连接体321的宽度W2(如图5所示)为0.1~0.3mm。
第一连接体221的宽度W1(如图6所示)与第一重复单体11的宽度W3(如图7所示)相等。第二重复单体211的宽度W4(如图6所示)和第三重复单体311的宽度W5(如图5所示)可以采用常规宽度,例如0.1~0.3mm。
本实施例中,血管支架的厚度0.1~0.3mm(无图示),血管支架的厚度是指血管支架的横截面的外径与内径之差。
本实施例中,第一重复单体11的前端部为圆角,圆角的圆弧内侧半径大于0.1mm(无图示),从而减少了血管支架对血管的刺激。
本实施例中,第一重复单体11的长度L1为5~15mm,优选为10~15mm,第一重复单体11的长度过长,会导致第一重复单体11的前端部碰触到对面的血管壁而造成对血管的刺激等不利影响;第一重复单体11的长度过短,则会影响血管支架在髂静脉中的定位,使得血管支架无法稳定地植入于所需位置。
中央支撑区段2的长度L2和末端支撑区段3的长度L3独立地为30~60mm,优选为30~40mm,第二重复单体211的长度L4和第三重复单体311的长度L5独立地为1~7mm,优选为2~5mm。即,中央支撑区段2大致包括8个中央支撑单元21,末端支撑区段3大致包括8个末端支撑单元31,当然,中央支撑单元21和末端支撑单元31的个数也可以根据实际需要进行调整。
本发明的血管支架在扩张状态时的总长度L6为50~120mm,优选为60~100mm。
实施例1和实施例2的上述内容相同,区别仅在与:实施例1中,多个第一重复单体11的前端部所形成的平面与血管支架的轴线相垂直,如图2和图3所示。实施例2中,多个第一重复单体11的前端部所形成的平面与血管支架的轴线相交,并且多个第一重复单体11的前端部所形成的平面与血管支架的轴线的夹角β为45°~89°,如图8至10所示,其中,图8至10中,多个第一重复单体11的前端部所形成的平面与血管支架的轴线的夹角β为70°,实施例2中,第一重复单体11的长度是逐渐变化的,但是,其长度范围应在上述限定的第一重复单体11的长度范围之内。
以上对本发明做了详尽的描述,其目的在于让熟悉此领域技术的人士能够了解本发明的内容并加以实施,并不能以此限制本发明的保护范围,且本发明不限于上述的实施例,凡根据本发明的精神实质所作的等效变化或修饰,都应涵盖在本发明的保护范围之内。
Claims (14)
1.一种血管支架,其能够从具有第一横截面直径的压缩状态变化到具有被扩大了的第二横截面直径的扩张状态,其特征在于:
所述的血管支架包括在所述的血管支架的轴线方向上依次连接的定位区段(1)、中央支撑区段(2)和末端支撑区段(3),
所述的定位区段(1)包括沿着所述的血管支架的周向分布的多个第一重复单体(11),
所述的中央支撑区段(2)包括在所述的血管支架的轴线方向上彼此相接的至少两个中央支撑单元(21)和至少一个第一连接单元(22),所述的中央支撑单元(21)包括沿着所述的血管支架的周向分布的多个第二重复单体(211),
所述的末端支撑区段(3)包括在所述的血管支架的轴线方向上彼此相接的至少两个末端支撑单元(31)和至少一个第二连接单元(32),所述的末端支撑单元(31)包括沿着所述的血管支架的周向分布的多个第三重复单体(311),
所述的第一重复单体(11)的个数与所述的第二重复单体(211)的个数不同,所述的中央支撑区段(2)的支撑力大于所述的末端支撑区段(3)的支撑力,多个所述的第一重复单体(11)的前端部所形成的平面与所述的血管支架的轴线相垂直。
2.根据权利要求1所述的血管支架,其特征在于:所述的第一重复单体(11)的个数小于所述的第二重复单体(211)的个数。
3.根据权利要求2所述的血管支架,其特征在于:所述的第二重复单体(211)的个数为所述的第一重复单体(11)的个数的2~4倍,所述的第一重复单体(11)的个数为4至10个。
4.根据权利要求1所述的血管支架,其特征在于:所述的中央支撑区段(2)的前端部连接有第一显影单元(4)。
5.根据权利要求1所述的血管支架,其特征在于:所述的定位区段(1)的延伸方向与所述的血管支架的轴线方向的夹角为0°~60°。
6.根据权利要求1所述的血管支架,其特征在于:所述的第一重复单体(11)的前端部为圆角,圆角的圆弧内侧半径大于等于0.1mm。
7.根据权利要求1所述的血管支架,其特征在于:所述的第一重复单体(11)的长度为5~15mm,所述的中央支撑区段(2)和所述的末端支撑区段(3)的长度独立地为30~60mm,所述的血管支架的厚度为0.1~0.3mm。
8.根据权利要求1所述的血管支架,其特征在于:所述的末端支撑区段(3)的后端部连接有多个第二显影单元(5),所述的第二显影单元(5)的个数为3至10个。
9.根据权利要求1所述的血管支架,其特征在于:所述的第一连接单元(22)包括沿着所述的血管支架的周向分布的多个第一连接体(221),所述的第二连接单元(32)包括沿着所述的血管支架的周向分布的多个第二连接体(321),所述的第一连接体(221)的个数不多于所述的第二重复单体(211)的个数,所述的第二连接体(321)的个数不多于所述的第三重复单体(311)的个数,所述的第二重复单体(211)的个数与所述的第三重复单体(311)的个数相等。
10.根据权利要求9所述的血管支架,其特征在于:所述的第一连接体(221)的宽度比所述的第二连接体(321)的宽度宽10%~30%,所述的第二连接体(321)的宽度为0.1~0.3mm。
11.根据权利要求1所述的血管支架,其特征在于:所述的血管支架的材质为不锈钢、记忆合金、钛合金、钽合金、钴铬合金、生物可降解金属、生物可降解聚合物、镁合金、纯铁中的一种或多种。
12.一种如权利要求1至11中任一项所述的血管支架的制备方法,其特征在于:将材料按照支架设计图纸上的路径进行激光切割,然后经酸洗、电化学工艺处理得到所述的血管支架。
13.一种如权利要求1至11中任一项所述的血管支架在分叉血管中的用途。
14.一种如权利要求1至11中任一项所述的血管支架在髂静脉中的用途。
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