CN116687634B - 一种超声波下输送的可穿刺覆膜支架 - Google Patents
一种超声波下输送的可穿刺覆膜支架 Download PDFInfo
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Abstract
一种超声波下输送的可穿刺覆膜支架,包括:支撑骨架,所述支撑骨架为螺旋状,由波浪形的环状支撑单元首尾相连组成;第一支撑膜,所述支撑单元上下穿插于所述第一支撑膜上,使得所述支撑单元的波峰和波谷位于所述第一支撑膜的一侧,波杆位于所述第一支撑膜的另一侧;所述第一支撑膜上设有微孔,所述微孔内部完全填充有可降解聚合物,所述支撑骨架黏附或凹陷进所述第一支撑膜;促增生涂层,所述促增生涂层涂敷于覆膜支架外表面;所述第一支撑膜的构造可以使其在超声植入过程中被清晰探测到,当所述可降解聚合物降解后,血管组织就可以在所述促增生涂层的作用下较快的生长入所述微孔内,使得支架表面与血管组织紧密贴合,防止穿刺过程中产生夹层。
Description
技术领域
本发明专利涉及医疗器械领域,尤其涉及一种超声波下输送的可穿刺覆膜支架。
背景技术
自体动静脉内瘘(Autogenous arteriovenous fistula,AVF)是我国目前血液透析血管通路最常见的形式,血管狭窄是AVF最常见的并发症,常见狭窄部位为动静脉吻合口后2-5cm的静脉。球囊扩张和支架植入是治疗AVF狭窄的常规方法。目前治疗血管狭窄的主要产品之一为覆膜支架,由于其远期通畅率高于裸支架支架,而受到广大医生的喜欢。
市面上的外周血管覆膜支架的金属丝骨架较为细集,一般不能用于血液透析穿刺,穿刺针进入可受到金属丝骨架的阻挡,穿刺针压迫和切割也可导致金属丝骨架变形和折断。并且在覆膜支架植入早期,覆膜与血管壁并未产生粘连,穿刺时有可能会使膜与血管内壁分离,在支架和血管壁之间可能产生血肿。这些原因导致覆膜支架段的血管无法进行透析穿刺,而血液透析病人需要频繁地进行血管穿刺,传统覆膜支架虽然治疗了血管狭窄,但也使得可正常穿刺的血管长度缩短,透析患者的资源十分珍贵,所以很有必要将支架段的血管利用起来用于穿刺。
另外,血管支架的植入通常是在X射线的辅助下进行,但X射线具有辐射性,危害医生和患者的身体健康,另外超声介入器材的定位具有细节显示和适时显示的优势,所以开始有医生使用超声来引导支架的植入。覆膜支架一般采用ePTFE作为主要覆膜材料,但ePTFE膜本身存在大量微米级的缝隙,内含空气,不利于超声的成像。
覆膜支架的边缘性狭窄是其在血液透析血管通路领域使用出现的主要并发症,常需要反复进行球囊扩张治疗或者植入新支架,其发生的主要机制为支架持续外扩力和ePTFE材料对血管的刺激以及支架植入后血流动力学的改变,所以覆膜支架的内表面还需要涂敷一些物质来预防覆膜支架的狭窄。
发明内容
本发明的目的在于克服以上不足,提供一种超声波下输送的可穿刺覆膜支架。
本发明所采用的技术方案如下:
一种超声波下输送的可穿刺覆膜支架,其特征在于,包括:支撑骨架,所述支撑骨架为螺旋状,由波浪形的环状支撑单元首尾相连组成;第一支撑膜,所述支撑单元上下穿插于所述第一支撑膜上,使得所述支撑单元的波峰和波谷位于所述第一支撑膜的一侧,波杆位于所述第一支撑膜的另一侧;所述第一支撑膜上设有微孔,所述微孔内部完全填充有可降解聚合物,所述支撑骨架黏附或凹陷进所述第一支撑膜;促增生涂层,所述促增生涂层涂敷于覆膜支架外表面;所述第一支撑膜的构造可以使其在超声植入过程中被清晰探测到,当所述可降解聚合物降解后,血管组织就可以在所述促增生涂层的作用下较快的生长入所述微孔内,使得支架表面与血管组织紧密贴合,防止穿刺过程中产生夹层。
优选的,所述第一支撑膜和所述支撑骨架通过粘接或热合固定到一起。
优选的,每层所述支撑单元的间距为2mm-6mm。
优选的,所述支撑骨架完全陷入所述第一支撑膜的其中一侧。
优选的,还包括第二支撑膜,所述第二支撑膜黏附在未完全陷入所述第一支撑膜的一侧,所述第一支撑膜和第二支撑膜将所述支撑骨架完全包裹。
优选的,所述第二支撑膜上的微孔内填充有可降解聚合物。
优选的,所述第二支撑膜为条状或筒状。
优选的,还包括第三支撑膜,第二支撑膜和所述第三支撑膜将所述第一支撑膜夹在中间。
优选的,所述支撑骨架由镍钛丝通过热处理定型而成。
优选的,所述促增生涂层为四环素涂层。
优选的,所述覆膜支架内表面涂敷有抗凝血物质。
优选的,所述抗凝血物质为肝素。
优选的,所述覆膜支架端口的内表面涂敷有抗增生物质。
优选的,所述抗增生物质为雷帕霉素、紫杉醇及其衍生物中的至少一种。
优选的,所述可降解聚合物为聚乳酸、聚乙醇酸及其共聚物、聚二氧烷酮、聚果皮内酯、聚磷嗪、胶原蛋白、明胶、壳聚糖或糖胺聚糖中的至少一种。
附图说明
图1为本发明一种超声波下输送的可穿刺覆膜支架结构示意图;
图2为本发明支撑骨架示意图;
图3为本发明支撑膜示意图;
图4为本发明的一种实施例;
图5为本发明在被穿刺时的示意图。
实施方式
下面结合附图和实施例对本发明的实施方式作进一步详细描述。以下实施例用于说明本发明,但不能用来限制本发明的范围。
一种超声波下输送的可穿刺覆膜支架,包括:支撑骨架100,所述支撑骨架100为螺旋状,由波浪形的支撑单元110首尾相连组成;所述支撑单元上下穿插于第一支撑膜200上,使得所述支撑单元110的波峰111和波谷112位于所述第一支撑膜200的一侧,波杆113位于所述第一支撑膜20的另一侧,如图1所述;所述第一支撑膜200上设有微孔210,所述微孔内部完全填充有可降解聚合物,所述支撑骨架100黏附或凹陷进所述第一支撑膜200;覆膜支架的外表面还涂敷有促增生涂层;所述第一支撑膜200和所述支撑骨架100通过粘接或热合固定到一起。
支撑骨架100为螺旋筒状结构,如图2所示,每层的支撑单元110具有一定的间隔,间距为2mm-6mm,间隔的大小影响着支架整体的径向支撑力,优选的,支撑骨架100两端的支撑单元100的间距小于中间段的间距,这样可以增加支架的抗位移性能。支撑骨架100是一根镍钛丝通过热处理定型而成的一体结构,镍钛合金材料拥有超弹性,所以在其被压缩后,可以自扩张到原始形状,就可以在血管内提供优异的径向支撑力,使支架贴合血管。制作时,首先使用模具将镍钛合金丝固定成一定形状,然后再进行高温热处理使镍钛丝定形,然后就可以获得预期结构的金属裸支架,此时裸支架表面会因热处理而形成氧化层,可能会增加血栓的风险,所以还需要进行抛光处理,使裸支架表面呈光亮态。在另一种实施例,支撑单元为封闭的环状,每层相互独立,通过第一支撑膜200将每层连接起来。
支撑骨架100的材料也可以根据需求进行更改,如不锈钢、L605钢、聚合物、MP35N钢、不锈钢、聚合物材料、钴、铬、镍合金,或者高分子材料,如聚(对苯二甲酸乙二醇酯)(PET)或聚四氟乙烯(PTFE),或者生物可降解材料,如聚乳酸-羟基乙酸共聚物(PLGA)或聚乳酸(PLA),或者上述材料的组合。加工过程中,同样可以先使用模具将丝固定成一定形状,然后热处理定形。
支撑单元110的波形为W型、S型或U型,优选为U型,因为U型波拐角处圆润,可以减小应力集中,增加支架的疲劳寿命。波的高度和间距影响着支架的径向支撑力,波的高度越高、间距越小,支架的支撑力越小,柔韧性越差;波的高度越低、间距越大,支架的支撑力越大,柔韧性越好。制作支撑骨架100的镍钛丝直径也会影响支架的力学性能,直径越大,支架支撑力越大,柔韧性越差,优选的,镍钛丝直径为0.15mm-0.3mm之间。
支撑骨架100本身为松散状态,其自身无法提供径向支撑力,所以需要第一支撑膜200对其进行约束,第一支撑膜200为高分子材料,如PTFE(聚四氟乙烯)、PE(聚乙烯)或FEP(全氟乙烯丙烯共聚物),其表面有许多微米级的孔洞,如图3所示,这些孔洞的存在有助于血管组织长入膜内,使支架和血管贴合的更加紧密,这样在穿刺过程中就不容易形成夹层,但这些孔洞的存在不利于支架被超声探测到,所以孔洞中还填充有可降解聚合物,可降解聚合物降解后,孔洞就会再次显露出来,为了让患者可以尽快在支架植入部位进行穿刺,第一支撑膜200表面还涂敷有促进组织增生的涂层,如四环素,促进增生涂层的存在可以加快血管组织长入第一支撑膜200的孔洞中,让血管支架和血管内壁紧密贴合在一起。
支撑骨架100上下穿插在第一支撑膜200上,这样就可以在轴向和周向约束住支撑骨架100,使其能提供稳定的径向支撑力。但穿插之后,支撑骨架100和第一支撑膜200之间会存在间隙,所以需要用粘合剂将支撑骨架100粘接在第一支撑膜200上。优选的,第一支撑骨架100通过热合的方式固定连接在第一支撑膜200上,首先将穿插好的支架套在一金属棒上,然后外部缠绕上绑扎带以对内部施加压力,使支撑骨架100和第一支撑膜200紧密贴合,绑扎带可以为PTFE等高分子材料,然后将金属棒放入热处理炉加热,在高温下第一支撑膜200开始软化,支撑骨架100就会凹陷进第一支撑膜200内,这种方法可以使支撑骨架100和第一支撑膜200贴合的更加牢固。在一种实施例中,第一支撑膜200的厚度较厚,通过上述热处理方法可以将支撑骨架100完全陷入所述第一支撑膜200中,这样的话所述支撑骨架100就被第一支撑膜200完全包裹,隔绝血液,提升了支架的生物兼容性能,但是这种实施例会导致第一支撑膜的厚度较厚,影响支架的柔顺性。所以在另一种实施例中,经过上述热处理方法,可以将支撑骨架100完全陷入第一支撑膜200的一侧,而另一侧的支撑骨架还暴露在外面,然后通过第二支撑膜300将暴露一侧的支撑骨架100包裹起来,再通过热处理的方式将第一支撑膜100和第二支撑膜300热合到一起,第二支撑膜300可以是条状、片状或者筒状,如果是条状的话,条状第二支撑膜需要沿着支撑骨架螺旋线的方向将露出的支撑骨架包裹起来。如果想进一步减小覆膜支架的厚度,增加柔顺性能,可以引入第三支撑膜,三层支撑膜的厚度按需选择,优选的,厚度为10-100μm,在这种厚度下,支撑骨架100只能粘贴在第一支撑膜200表面,第一支撑膜200两侧的支撑骨架都会暴露出来,然后使用第二支撑膜和第三支撑膜将支撑骨架100和第一支撑膜夹在中间,然后通过热合的方式将三层膜结合到一起,这种实施例既可以将支撑骨架100完全包裹起来,增加了支架的生物相容性能,又可以尽可能保留支架的柔顺性能。无论是几层支撑膜,促增生涂层都是涂敷在最外层的支撑膜上。三层支撑膜的结构类似,都有微孔结构,微孔中部分或完全填充有可降解聚合物,为了达到较好的超声显影效果,微孔中需要尽可能多的填充进可降解聚合物。所述可降解聚合物为聚乳酸、聚乙醇酸及其共聚物、聚二氧烷酮、聚果皮内酯、聚磷嗪、胶原蛋白、明胶、壳聚糖或糖胺聚糖中的至少一种。
覆膜支架的边缘性狭窄是其在血液透析血管通路领域使用出现的主要并发症,常需要反复进行球囊扩张治疗或者植入新支架,其发生的主要机制为支架持续外扩力和ePTFE材料对血管的刺激以及支架植入后血流动力学的改变。所以在一种实施例中,覆膜支架内表面还涂敷有抗凝血物质,如,肝素;在另一种实施例中,覆膜支架端口的内表面还可以涂敷抗增生物质,如,雷帕霉素、紫杉醇及其衍生物中的至少一种。
在临床使用过程中,因为支撑膜的微孔被填充起来,所以在输送过程中,支架可以在超声过程中清晰的显影出来,AVF吻合口部位的血管立体构型有时很复杂,超声多角度地细节现象在该部位的优势更加明显,可以更加准确的释放支架,支架被释放后,微孔中的可降解聚合物就会逐渐降解,降解后显露出来的微孔就会被血管组织填充,使血管内壁和支架的结合更加紧密贴合,而四环素的存在可以加快这一过程,可降解聚合物的降解周期在一个月到半年。透析患者的血管资源十分宝贵,所以需要尽可能利用放置有支架的血管段,本发明支架的覆膜和血管组织紧密贴合可以防止穿刺过程中血管组织和覆膜分离,形成夹层,所有医生可以有效地利用这段血管资源。
所描述的实施方案在所有方面仅被认为是说明性的而不是限制性的。因此,本公开的范围由所附的权利要求而不是由前面的说明书来表示。在权利要求的等同的含义和范围内的所有改变都被包括在其范围内。本发明并不局限于上述实施例,即不意味着本发明必须依赖上述实施例才能实施。所属技术领域的技术人员应该明了,对本发明的任何改进,对本发明所选用原料的等效替换及辅助成分的添加、具体方式的选择等,均落在本发明的保护范围和公开范围之内。
Claims (15)
1.一种超声波下输送的可穿刺覆膜支架,其特征在于,包括:
支撑骨架,所述支撑骨架为螺旋状,由波浪形的环状支撑单元首尾相连组成;
第一支撑膜,所述支撑单元上下穿插于所述第一支撑膜上,使得所述支撑单元的波峰和波谷位于所述第一支撑膜的一侧,波杆位于所述第一支撑膜的另一侧;所述第一支撑膜上设有微孔,所述微孔内部完全填充有可降解聚合物,所述支撑骨架黏附或凹陷进所述第一支撑膜;
促增生涂层,所述促增生涂层涂敷于覆膜支架外表面;
所述第一支撑膜的构造可以使其在超声植入过程中被清晰探测到,当所述可降解聚合物降解后,血管组织就可以在所述促增生涂层的作用下较快的生长入所述微孔内,使得支架表面与血管组织紧密贴合,防止穿刺过程中产生夹层。
2.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述第一支撑膜和所述支撑骨架通过粘接或热合固定到一起。
3.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,每层所述支撑单元的间距为2mm-6mm。
4.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述支撑骨架完全陷入所述第一支撑膜的其中一侧。
5.根据权利要求4所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,还包括第二支撑膜,所述第二支撑膜黏附在未完全陷入所述第一支撑膜的一侧,所述第一支撑膜和第二支撑膜将所述支撑骨架完全包裹。
6.根据权利要求5所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述第二支撑膜上的微孔内填充有可降解聚合物。
7.根据权利要求5所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述第二支撑膜为条状或筒状。
8.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,还包括第三支撑膜,第二支撑膜和所述第三支撑膜将所述第一支撑膜夹在中间。
9.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述支撑骨架由镍钛丝通过热处理定型而成。
10.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述促增生涂层为四环素涂层。
11.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述覆膜支架内表面涂敷有抗凝血物质。
12.根据权利要求11所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述抗凝血物质为肝素。
13.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述覆膜支架端口的内表面涂敷有抗增生物质。
14.根据权利要求13所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述抗增生物质为雷帕霉素、紫杉醇及其衍生物中的至少一种。
15.根据权利要求1所述的一种超声波下输送的可穿刺覆膜支架,其特征在于,所述可降解聚合物为聚乳酸、聚乙醇酸及其共聚物、聚二氧烷酮、聚果皮内酯、聚磷嗪、胶原蛋白、明胶、壳聚糖或糖胺聚糖中的至少一种。
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