CN113520685A - 用于血管的支架 - Google Patents
用于血管的支架 Download PDFInfo
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- CN113520685A CN113520685A CN202110886550.8A CN202110886550A CN113520685A CN 113520685 A CN113520685 A CN 113520685A CN 202110886550 A CN202110886550 A CN 202110886550A CN 113520685 A CN113520685 A CN 113520685A
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- Prior art keywords
- stent
- blood vessel
- film
- cover film
- anchoring
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Abstract
本发明涉及一种用于血管的支架。该支架包括:相连接的包覆膜与锚定件;锚定件用于将包覆膜固定在血管内;包覆膜用于兜拢血管的病变部位。该支架的锚定件用于在支架受到血液的冲刷时将包覆膜更好地贴附血管内膜,固定在预期植入位置,包覆膜可以兜拢血管内膜上的不稳定斑块,避免不稳定斑块破裂,同时包覆膜也可以在生物体内引发异物反应,从而刺激血管内皮生长,使不稳定斑块生长为稳定斑块,减小急性血栓发生率。且该支架也可以用于介入过程中血管撕裂的处理,避免撕裂血管壁脱落造成血栓事件。
Description
技术领域
本发明涉及医疗器械技术领域,特别是涉及一种用于血管的支架。
背景技术
目前认为动脉粥样硬化是一种慢性炎症疾病,其主要病变特征为动脉某些部位的内膜下脂质沉积,并伴有平滑肌细胞和纤维基质成分的增殖,逐步发展形成动脉粥样硬化性斑块,从而引起血管管腔狭窄或血栓形成。其中,斑块随着病变的慢性进展逐渐扩大,分为稳定性或不稳定性斑块。不稳定性斑块的特征是由薄且不稳定的纤维帽覆盖大的脂质核心,易于破裂,突然破裂可导致血栓形成,进而导致急性动脉症状,风险较高。相反,稳定性斑块的纤维帽较厚,不容易破裂,临床表现为体力活动诱发缺血导致的症状。
研究发现,动脉粥样硬化血栓形成和血栓栓塞并发症的风险似乎更多地与动脉粥样硬化斑块的稳定性相关,而不是与斑块的大小相关。稳定性心绞痛与光滑的纤维性冠状动脉斑块(稳定性斑块)有关,而不稳定性心绞痛、急性心肌梗死(AMI)和心源性猝死几乎均与斑块的不稳定性相关。
发明内容
基于此,有必要针对现有的动脉粥样硬化性斑块易破裂的技术问题,提供一种用于血管的支架。
一种用于血管的支架,所述支架包括:相连接的包覆膜与锚定件;
所述锚定件沿所述支架的轴向设置于所述支架的两端,用于将所述支架固定在血管内;
所述包覆膜通过所述锚定件固定,用于兜拢所述血管的病变部位,其中所述包覆膜的外表面包含细胞黏附物质。
在其中一个实施例中,所述包覆膜为生物可吸收材质,其中所述生物可吸收材质包括聚酯类、聚碳酸酯及其复合物的至少一种。
在其中一个实施例中,所述包覆膜的孔隙率为50%~100%。
在其中一个实施例中,所述包覆膜的沿所述支架轴向依次分布的两端部的孔隙率大于中部的孔隙率。
在其中一个实施例中,所述包覆膜的厚度小于或等于100μm。
在其中一个实施例中,位于所述支架同一端部上的所述锚定件的数目为多个且所述锚定件沿所述支架的轴向依次分布。
在其中一个实施例中,位于所述支架同一端部上的相邻两个所述锚定件间隔分布并通过连接件相连。
在其中一个实施例中,位于所述支架不同端部且相邻的两个所述锚定件之间连接有至少一个支撑件,所述支撑件位于所述包覆膜的内侧。
在其中一个实施例中,所述支撑件还固定于所述包覆膜的中部。
在其中一个实施例中,所述支撑件在所述支架轴向上的长度大于位于所述支架不同端部且相邻的两个所述锚定件之间的距离,以将所述包覆膜拱起。
在其中一个实施例中,所述支撑件在所述支架轴向上的长度比位于所述支架不同端部且相邻的两个所述锚定件间的距离长5%~20%。
在其中一个实施例中,位于所述支架端部的的锚定件与所述包覆膜间隔分布并通过安装件与所述包覆膜连接。
在其中一个实施例中,所述锚定件由一字形、波浪形或弯折形的锚定条首、尾连接而成。
在其中一个实施例中,所述锚定件的宽度为50μm~5000μm。
在其中一个实施例中,所述锚定件的贴近所述血管内壁的区域设置有凹槽。
上述用于血管的支架,锚定件用于在支架受到血液的冲刷时将包覆膜更好地贴附血管内膜,固定在预期植入位置,包覆膜用于兜拢血管内膜上的不稳定斑块,避免不稳定斑块破裂,且包覆膜的外表面包含细胞黏附物质,该细胞黏附物质可利用相似相溶原理与血管壁上的细胞间形成粘接力,可防止包覆膜由于兜拢力度不够而过度塌陷,从而保证包覆膜能够有效起到兜拢病变部位(尤其是体积过大或重量过大的病变部位)的作用,有效避免不稳定斑块破裂,同时包覆膜也可以在生物体内引发异物反应,从而刺激血管内皮生长,使不稳定斑块生长为稳定斑块,减小急性血栓发生率。且该支架也可以用于介入过程中血管撕裂的处理,避免撕裂血管壁脱落造成血栓事件。
附图说明
图1为本发明一实施例提供的用于血管的支架的结构示意图;
图2为本发明另一实施例提供的用于血管的支架的结构示意图;
图3为本发明另一实施例提供的用于血管的支架的结构示意图;
图4为本发明另一实施例提供的用于血管的支架的结构示意图;
图5为本发明另一实施例提供的用于血管的支架的结构示意图。
其中,附图中的标号说明如下:
100、包覆膜;200、锚定件;300、连接件;400、支撑件;500、安装件。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施例的限制。
在本发明的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。
此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本发明的描述中,“多个”的含义是至少两个,例如两个,三个等,除非另有明确具体的限定。
在本发明中,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系,除非另有明确的限定。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。
在本发明中,除非另有明确的规定和限定,第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触,或第一和第二特征通过中间媒介间接接触。而且,第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方,或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方,或仅仅表示第一特征水平高度小于第二特征。
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。
参阅图1,图1示出了本发明一实施例中的用于血管的支架的结构示意图,本发明一实施例提供了的用于血管的支架,该支架包括相连接的包覆膜100与锚定件200;锚定件200沿支架的轴向设置于支架的两端,用于将支架固定在血管内;包覆膜100通过锚定件200固定,用于兜拢血管的病变部位,其中包覆膜100的外表面包含细胞黏附物质
在本实施例中,血管的病变部位可指血管内膜上的不稳定斑块,也可指血管内膜的撕裂区域等引起血栓的病变部位。需要说明的是,本文中的“兜拢”是指兜住、拢住的意思,即可向血管内膜上的病变部位(例如不稳定斑块)提供一个支撑力,避免不稳定斑块过度塌陷,从而能够有效避免不稳定斑块破裂。
在本实施例中,包覆膜100的外表面所包含的细胞黏附物质与血管壁上的细胞表层的成分相似,从而可利用相似相溶原理与血管壁上的细胞间形成粘接力,那么在血管的病变部位过大或过重时,可以利用该粘接力防止包覆膜100由于兜拢力度不够而过度塌陷,从而保证包覆膜100能够有效起到兜拢病变部位的作用。制备时,可直接在包覆膜100的表面上涂抹细胞黏附物质之后晾晒或干燥即可。其中,细胞粘附物质可包括蛋白质、生理活性物质及化合物中的至少一种。
作为上述蛋白质,例如可举出癌胚抗原、扁平上皮癌相关抗原、细胞角蛋白19片段、唾液酸化糖链抗原KL-6、利尿钠肽、肌钙蛋白、肌红蛋白等疾病标记物、白细胞介素-1(IL-1)、白细胞介素-2(IL-2)、白细胞介素-3(IL-3)、白细胞介素-4(IL-4)、白细胞介素-5(IL-5)、白细胞介素-6(IL-6)、白细胞介素-7(IL-7)、白细胞介素-8(IL-8)、白细胞介素-9(IL-9)、白细胞介素-10(IL-10)、白细胞介素-11(IL-11)、白细胞介素-12(IL-12)、白细胞介素-13(IL-13)、白细胞介素-14(IL-14)、白细胞介素-15(IL-15)、白细胞介素-18(IL-18)、白细胞介素-21(IL-21)、干扰素-α(IFN-α)、干扰素-β(IFN-β)、干扰素-γ(IFN-γ)、粒细胞集落刺激因子(G-CSF)、单核细胞集落刺激因子(M-CSF)、粒细胞-巨噬细胞集落刺激因子(GM-CSF)、干细胞因子(SCF)、flk2/flt3配体(FL)、白血病细胞抑制因子(LIF)、抑瘤素M(OM)、促红细胞生成素(EPO)、促血小板生成素(TPO)、转化生长因子-α(TGF-α)、转化生长因子-β(TGF-β)、巨噬细胞炎性蛋白-1α(MIP-1α)、表皮细胞生长因子(EGF)、成纤维细胞生长因子1、2、3、4、5、6、7、8、或9(FGF-1、2、3、4、5、6、7、8、9)、神经细胞生长因子(NGF)、肝细胞生长因子(HGF)、白血病抑制因子(LIF)、蛋白酶连接蛋白(protease nexin)I、蛋白酶连接蛋白II、血小板衍生生长因子(PDGF,platelet-derived growth factor receptor)、胆碱能分化因子(CDF)、趋化因子、Notch配体(Delta1等)、Wnt蛋白质、血管生成素样蛋白2、3、5或7(Angpt2、3、5、7)、胰岛素样生长因子(IGF)、胰岛素样生长因子结合蛋白质(IGFBP)、多效蛋白(Pleiotrophin)、胰岛素、生长激素等细胞生长因子、以及胶原I至XIX、纤连蛋白、玻连蛋白、层粘连蛋白-1至12、层粘连蛋白511、层粘连蛋白521、nitogen(日文:ニトジェン)、腱生蛋白、血小板反应蛋白、血管性血友病因子、骨桥蛋白、纤维蛋白原、各种弹性蛋白、各种蛋白多糖、各种钙黏蛋白(cadherin)、桥粒胶蛋白(desmocolin)、桥粒芯蛋白、各种整联蛋白、E-选择蛋白、P-选择蛋白、L-选择蛋白、免疫球蛋白超家族、基质胶(Matrigel)、多聚-D-赖氨酸、多聚-L-赖氨酸等细胞粘附因子、IgG、IgM、IgA、IgD、IgE等各种抗体等。
作为上述生理活性物质,例如可举出D-氨基葡萄糖、D-半乳糖胺、神经氨酸、透明质酸、硫酸软骨素、硫酸乙酰肝素(heparan sulfate)、肝素等糖类、血清素、去甲肾上腺素、肾上腺素、3-(3,4-二氯苯基)-1,1-二甲基脲(DCMU)、莠去津、利谷隆及西玛津等。
作为上述化合物,例如可举出血管紧张素I至IV、缓激肽、血纤肽、利尿钠肽、尿扩张素、鸟苷肽、内皮素1至3、salusin、硬骨鱼紧张肽(urotensin)、催产素、后叶激素运载蛋白、抗利尿激素、促肾上腺皮质激素、黑色素细胞刺激素、内啡肽、促脂素、尿皮素(urocortin)1至3、促黄体生成素释放激素、生长激素释放激素、生长激素抑制素、皮质醇稳定蛋白(cortistatin)、催乳素释放肽、转移抑素(metastin)、速激肽、P物质、神经激肽、endokinin、神经降压素、神经调节肽(neuromedin)、爱森藻肽(日文:ゼニン)、生长素释放肽(ghrelin)、肥胖抑制素(obestatin)、黑色素浓缩激素、食欲肽、神经肽、强啡肽、新内啡肽、内吗啡肽、伤害感受肽(nociceptin)、焦谷氨酰化RF酰胺肽、甘丙肽、胃泌激素、缩胆囊素、胰泌素(secretin)、松弛肽、胰高血糖素、肠高血糖素、肾上腺髓质素、香树素、降钙素、甲状旁腺激素、防御素、胸腺素、YIGSR肽等肽;丙氨酸、精氨酸、天冬酰胺、天冬氨酸、半胱氨酸、谷氨酰胺、谷氨酸、甘氨酸、组氨酸、异亮氨酸、亮氨酸、赖氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、苏氨酸、色氨酸、酪氨酸、缬氨酸、胱氨酸、羟基脯氨酸、羟基赖氨酸、二羟基苯丙氨酸、甲状腺素、磷酸丝氨酸、锁链素、β-丙氨酸、肌氨酸、鸟氨酸、肌酸、γ-氨基丁酸、茶氨酸(theanine)、红藻氨酸、软骨藻酸、鹅膏蕈氨酸等氨基酸;2-二甲基氨基乙基胺(CAS号:108-00-9的化合物)、N-(2-羟乙基)乙二胺(CAS号:111-41-1的化合物)、N-(2-氨基乙基)哌嗪(CAS号:140-31-8的化合物)、4-(2-氨基乙基)吗啉(CAS号:2038-03-1的化合物)、1-(2-氨基乙基)-2-咪唑烷酮(CAS号:6281-42-1的化合物)、色胺(CAS号:61-54-1的化合物)、组胺二盐酸盐(CAS号:56-92-8的化合物)、酪胺(CAS号:51-67-2的化合物)、多巴胺(CAS号:51-61-6的化合物)等伯胺;乙二胺二盐酸盐(CAS号:333-18-6的化合物)、1,6-二氨基己烷(CAS号:124-09-4的化合物)、N,N’-双(氨基丙基)哌嗪(CAS号:7209-38-3的化合物)的伯二胺等。
如上所述的用于血管的支架,锚定件200用于在支架受到血液的冲刷时将包覆膜100更好地贴附血管内壁,固定在预期植入位置,包覆膜100用于兜拢血管内膜上的不稳定斑块,且包覆膜100的外表面包含细胞黏附物质,该细胞黏附物质可利用相似相溶原理与血管壁上的细胞间形成粘接力,可防止包覆膜100由于兜拢力度不够而过度塌陷,从而保证包覆膜100能够有效起到兜拢病变部位(尤其是体积过大或重量过大的病变部位)的作用,有效避免不稳定斑块破裂,同时包覆膜100也可以在生物体内引发异物反应,从而刺激血管内皮生长,使不稳定斑块生长为稳定斑块,减小急性血栓发生率。且该支架也可以用于介入过程中血管撕裂的处理,避免撕裂血管壁脱落造成血栓事件。
在颈动脉粥样硬化性疾病患者中,斑块不规则和破裂与脑缺血事件密切相关,具有不规则或溃疡性斑块的患者表现出较高的缺血性卒中风险,而与管腔狭窄的程度无关。针对该问题,在本发明的一些实施例中,包覆膜100的材质为柔性材质。该类材质的包覆膜100可以兜住不同形状的不稳定斑块,尤其是形状不规则的不稳定斑块,降低形状不规则斑块的患者表现出较高的缺血性卒中风险。可选地,包覆膜100为生物可吸收材质,其中生物可吸收材质包括聚酯类(例如聚己内酯、聚乳酸、聚乙丙交酯)、聚碳酸酯及其复合物的至少一种。生物可吸收材质的包覆膜100可在人体内被降解及吸收。
在本发明的一些实施例中,包覆膜100的孔隙率为50%~100%,例如设置为50%、55%、60%、65%、70%、75%、80%、85%、90、95%、100%等。如此,可以保证包覆膜100能够兜拢病变部位,又能保证包覆膜100的柔性。
具体地,包覆膜100的沿支架轴向依次分布的两端部的孔隙率大于中部的孔隙率。需要说明的是,包覆膜100的中部是指包覆膜100的位于沿支架轴向分布的两端部之间的部位。可以理解的是,包覆膜100包括两个端部(即第一端部、第二端部)及中部,该第一端部、中部、第二端部沿支架的轴向依次分布,即沿血流方向依次分布。包覆膜100的中部用于兜拢血管的病变部位,需要较高的密度;包覆膜100的两端一般用来安装锚定件200,对密度的要求较低,较小的密度可以节省材料及降低加工难度。在应用时,可根据具体情况,对包覆膜100两端及中部的孔隙率进行设置。
在本发明的一些实施例中,包覆膜100的厚度小于或等于100μm,例如可以设置为100μm、90μm、80μm、70μm、60μm等。如此,便于细胞更好的延展到包覆膜100的中部,加快血管内皮化,也可以使得包覆膜100更柔软,且也可以占用更少的血管管腔。优选地,包覆膜100的厚度小于或等于50μm,例如可以设置50μm、40μm、30μm、20μm、10μm等。
在本发明的一些实施例中,包覆膜100可通过编制、静电纺丝、压膜或镂空切割的方式加工形成。在应用时,可以根据包覆膜100的材质,选取对应的加工方式来制备包覆膜100。
在本发明的一些实施例中,如图1所示,位于支架同一端部上的锚定件200的数目为多个且锚定件200沿支架的轴向依次分布。可以理解的是,支架包括两个端部(即第一端部、第二端部),该第一端部、该第二端部沿支架的轴向依次分布,即沿血流方向依次分布,支架的“同一端部”是指支架的第一端部或第二端部。在支架的同一端部上设置多个锚定件200,可以提高包覆膜100在血管内的植入牢固程度。应用时,可以根据需求,具体来设置位于支架同一端部上的锚定件200的数目。示例地,例如图2所示出的包覆膜100的一端设置2个锚定件200,另一端设置3个锚定件200,再例如图3所示出的包覆膜100的两端各设置3个锚定件200。当然了,在本发明的另外一些实施例中,也可通过增大锚定件200在支架轴向上的长度,来增大锚定件200的锚定力度,此时可以看作,如图4所示,位于包覆膜100同一端部上的相邻两个锚定件200间彼此相贴合并相连,相邻两个锚定件200可以采用熔融焊接或一体化成型(例如激光雕刻成型)的方式相连。
进一步地,在本发明的一些实施例中,如图2所示,位于包覆膜100同一端部上的相邻两个锚定件200间隔分布并通过连接件300相连。可以理解的是,该包覆膜100的“同一端部”是指包覆膜100的第一端部或第二端部。如此,可以使得锚定件200构成镂空结构,加快血管内皮化进程,且血管输送系统能够更加省力地压握住锚定件200,从而便于支架的输送。可选地,连接件300的材质可与锚定件200的材质相同,连接件300的形状可以为一字形、弯折形、波浪形等,连接件300可采用熔融焊接或一体化成型(例如激光雕刻成型)的方式与锚定件200相连。
在本发明的其他一些实施例中,锚定件200的贴近血管内壁的区域也可以设置有凹槽。该凹槽可以利于细胞的长入,使得锚定件200更牢固地锚定在血管内,从而提高包覆膜100在血管内的植入牢固程度。关于凹槽的形状,本发明实施例不进行限定,可以为圆形、多边形等。需要说明的是,当锚定件200为环状时,锚定件200的面向血管内壁的壁即为锚定件200的贴近血管内壁的区域,而锚定件200的背向血管内壁的壁即为锚定件200的靠近支架中轴线的壁;当锚定件200包括多个环绕支架中轴线排布的凸起(例如楔形凸起)且凸起插入至血管内壁从而起到锚定的作用时,凸起的插入至血管内壁的壁即为锚定件200的远离支架中轴线的壁,凸起的未插入至血管内壁的壁即为锚定件200的贴近血管内壁的区域。其中,支架的中轴线延伸方向与血流的方向相平行。
在本发明的一些实施例中,锚定件200为环状结构。完整封闭的锚定件200可以保证包覆膜100与血管的内壁贴合良好。
具体地,锚定件200由一字形(参见图1、图3至图5)、波浪形(参见图2)或弯折形的锚定条首、尾连接而成。其中,当锚定件200由一字形锚定条首、尾连接而成时,可降低用于血管的支架的加工难度。当锚定件200由波浪形或弯折形的锚定条首、尾连接而成时,便于整体压缩支架,从而便于支架的植入。应用时,锚定件200可设置不同的形状,针对不同大小的病变位置进行兜拢。
在本发明的一些实施例中,锚定件200的宽度为50μm~5000mm,例如可以设置为50μm、100μm、1000μm、3000μm、5000μm等。锚定件200的宽度大于传统覆膜支架上每个金属波杆的宽度,该尺寸下的锚定件200可有效将包覆膜100锚定在血管内。需要说明的是,当包覆膜100上设置的锚定件200越多,锚定件200的宽度也可以相应减小。
在本发明的一些实施例中,锚定件200的材质包括镍钛合金、钴铬合金、不锈钢、锌铁合金、镁合金以及聚酯类、聚碳酸酯及其复合物的至少一种。其中,当锚定件200的材质为镍钛合金或一些具有形状记忆的聚酯类(例如聚氨酯)时,锚定件200能够自膨,如此可以无需借助工具(例如球囊)对锚定件200进行球扩,减少手术难度,也可以有效避免破坏血管的病变部位。当锚定件200的材质为其他材质时,锚定件200无法自膨,此时需要借助工具(例如球囊)对锚定件200进行球扩。当然了,球扩时,锚定件200的材质也可以具有形状记忆功能,这样可以使得锚定件200具有向外的张力,提高锚定效果。
在本发明的一些实施例中,如图2至图5所示,位于包覆膜100不同端部且相邻的两个锚定件200之间连接有至少一个支撑件400,支撑件400位于包覆膜100的内侧。在锚定件200撑开包覆膜100的过程中,支撑件400也可以辅助撑开包覆膜100。该支撑件400不仅减小包覆膜100的径向坍陷量,而且也可以减少支架的轴向回缩量。
可选地,支撑件400的材质可与锚定件200的材质相同,也可以不同。支撑件400可沿用于血管的支架的轴向分布,也可与用于血管的支架的轴向呈有夹角(例如5°、10°、20°等)。支撑件400的形状为一字形、弯折形、波浪形或螺旋形。支撑件400可以采用熔融焊接或一体化成型的方式(例如激光切割成型)与对应的锚定件200连接。
可选地,支撑件400还可固定于包覆膜100的中部。如此在锚定件200撑开包覆膜100的过程中,可以有效带动包覆膜100撑开。其中,支撑件400可以采用编织、粘接或熔融焊接的方式固定于包覆膜100的中部。
可选地,如图4所示,支撑件400在支架轴向上的长度大于位于包覆膜100不同端部且相邻的两个锚定件200间的距离,以将包覆膜100撑起。如此,可以解决包覆膜100由于过长而垂下的问题,可有效兜住尺寸较大的不稳定斑块。可选地,支撑件400在支架轴向上的长度比位于包覆膜100不同端部且相邻的两个锚定件200间的距离长5%~20%,例如长5%、10%、15%、20%等。如此设置,既可以避免支撑件400因长度过短而导致在将包覆膜100拱起时绷得太紧,也可以避免支撑件400因长度过长而导致支架与血管内壁间有间隙。
在本发明的一些实施例中,如图5所示,靠近包覆膜100端部的锚定件200与包覆膜100间隔分布并采用安装件500与包覆膜100连接。如此,可以降低包覆膜100的包覆率,使得细胞更好地爬到包覆膜100的中部,促进内皮化。可选地,安装件500可以为丝状(例如纤维丝),可在包覆膜100的端部沿周向牵拉出多股纤维丝。当然了,在本发明的另外一些实施例中,靠近包覆膜100端部的锚定件200可采用编织、熔融焊接、焊接等方式直接安装在包覆膜100上。在应用时,可以根据病变部位及包覆膜100的大小,来选择靠近包覆膜100端部的锚定件200与包覆膜100间的连接方式。
实施例1
该实施例提供一种用于血管的支架,如图2所示,该支架的一端设置有2个锚定件200,另一端设置有3个锚定件200,且同一端部相连的两个锚定件200之间通过一字形的连接件300相连。其中,锚定件200的材质为钴铬合金材料,锚定件200由激光切割为波纹形状,连接件300也通过激光切割的方式形成于锚定件200上。位于支架的不同端部且相邻的两个锚定件200之间通过编制打结方式连接一张PCL(聚己内酯)材质的包覆膜100,包覆膜100厚度为20微米并由静电纺丝制成。位于支架的不同端部且相邻的两个锚定件200之间还设置有等距分布的4根直径为10μm的PLLA(左旋聚乳酸)单丝,即支撑件400。PLLA单丝在包覆膜100的内侧,用于支架打开时辅助支撑包覆膜100。
实施例2
该实施例提供一种用于血管的支架,如图3所示,该用于血管的支架的两端各设置有一个注塑成型的聚碳酸酯锚定件200,且这两个锚定件200之间连接有宽度为50μm、厚度为10μm、材质为镍钛合金的支撑件400。该支撑件400通过缠绕锚定件200一圈再熔融焊接锚定件200上。该支撑件400的形状为一字形并沿支架的轴向分布,支撑件400的长度较锚定件200之间的距离长5%~20%,因此当支架释放时,支撑件400会略微向外凸起,将包覆膜100拉紧,避免塌陷。
实施例3
该实施例提供一种用于血管的支架,如图4所示,该支架的两端各设置有3个锚定件200,且同一端部相连的两个锚定件200之间贴合在一起。位于支架的不同端且相邻的两个锚定件200之间还设置有4根弯曲的支撑件400。支撑件400与锚定件200在聚乳酸管材上激光雕刻而成。位于支架的不同端且相邻的两个锚定件200之间通过编制方式连接一张聚乳酸材质的包覆膜100。其中,锚定件200的聚乳酸分子量在20万以上,大于包覆膜100所使用的聚乳酸材质的分子量,使其能够提供足够的支撑作用。锚定件200上还雕刻有凹槽,以增大固定力。
实施例4
该实施例提供一种用于血管的支架,如图5所示,该支架的两端各设置有一个锚定件200。这两个锚定件200之间设置有一字状的支撑件400,可增加对包覆膜100的支撑作用,其中支撑件400与锚定件200的材质均为钴铬合金。这两个锚定件200之间还通过编制的方式连接有由PCL和PGLA混合材料制成的包覆膜100,其中包覆膜100的孔隙率中间低、两端高,包覆膜100的两端部各拉出5股编织纤维丝(即安装件500),用于拴系在锚定件200上。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。
Claims (15)
1.一种用于血管的支架,其特征在于,包括相连的包覆膜(100)与锚定件(200);
所述锚定件(200)沿所述支架的轴向设置于所述支架的两端,用于将所述支架固定于所述血管内;
所述包覆膜(100)通过所述锚定件(200)固定,用于兜拢所述血管的病变部位,其中所述包覆膜(100)的外表面包含细胞黏附物质。
2.根据权利要求1所述的支架,其特征在于,所述包覆膜(100)为生物可吸收材质,其中所述生物可吸收材质包括聚酯类、聚碳酸酯及其复合物的至少一种。
3.根据权利要求1所述的支架,其特征在于,所述包覆膜(100)的孔隙率为50%~100%。
4.根据权利要求1-3任一项所述的支架,其特征在于,所述包覆膜(100)的沿所述支架轴向依次分布的两端部的孔隙率大于中部的孔隙率。
5.根据权利要求1-3任一项所述的支架,其特征在于,所述包覆膜(100)的厚度小于或等于100μm。
6.根据权利要求1-3任一项所述的支架,其特征在于,位于所述支架同一端部上的所述锚定件(200)的数目为多个且所述锚定件(200)沿所述支架的轴向依次分布。
7.根据权利要求6所述的支架,其特征在于,位于所述支架同一端部上的相邻两个所述锚定件(200)间隔分布并通过连接件(300)相连。
8.根据权利要求1-3任一项所述的支架,其特征在于,位于所述支架不同端部且相邻的两个所述锚定件(200)之间连接有至少一个支撑件(400),所述支撑件(400)位于所述包覆膜(100)的内侧。
9.根据权利要求8所述的支架,其特征在于,所述支撑件(400)还固定于所述包覆膜(100)的中部。
10.根据权利要求8所述的支架,其特征在于,所述支撑件(400)在所述支架轴向上的长度大于位于所述支架不同端部且相邻的两个所述锚定件(200)之间的距离,以将所述包覆膜(100)拱起。
11.根据权利要求10所述的支架,其特征在于,所述支撑件(400)在所述支架轴向上的长度比位于所述支架不同端部且相邻的两个所述锚定件(200)间的距离长5%~20%。
12.根据权利要求1-3任一项所述的支架,其特征在于,位于所述支架端部的锚定件(200)与所述包覆膜(100)间隔分布并通过安装件(500)与所述包覆膜(100)连接。
13.根据权利要求1-3任一项所述的支架,其特征在于,所述锚定件(200)由一字形、波浪形或弯折形的锚定条首、尾连接而成。
14.根据权利要求1-3任一项所述的支架,其特征在于,所述锚定件(200)的宽度为50μm~5000μm。
15.根据权利要求1-3任一项所述的支架,其特征在于,所述锚定件(200)的贴近所述血管内壁的区域设置有凹槽。
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CN115154662A (zh) * | 2022-04-28 | 2022-10-11 | 南开沧州渤海新区绿色化工研究有限公司 | 一种兼具抗凝血和促进内皮化功能的人工血管及其制备方法 |
WO2023011222A1 (zh) * | 2021-08-03 | 2023-02-09 | 上海微创医疗器械(集团)有限公司 | 用于血管的支架 |
TWI822450B (zh) * | 2021-11-26 | 2023-11-11 | 大陸商上海微創心脈醫療科技(集團)股份有限公司 | 覆膜支架及覆膜支架系統 |
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US7572286B1 (en) * | 2002-05-13 | 2009-08-11 | Advanced Cardiovascular Systems, Inc. | Stent assembly for the treatment of vulnerable plaque |
US7326238B1 (en) * | 2002-09-30 | 2008-02-05 | Abbott Cardiovascular Systems Inc. | Method and apparatus for treating vulnerable plaque |
KR20050091040A (ko) * | 2002-12-30 | 2005-09-14 | 안지오테크 인터내셔날 아게 | 실크 함유 스텐트 이식편 |
EP1984040A1 (en) * | 2006-01-31 | 2008-10-29 | Multi Gene Vascular Systems, Inc. | Drug-eluting intravascular prostheses and methods of use |
US20070179599A1 (en) * | 2006-01-31 | 2007-08-02 | Icon Medical Corp. | Vascular protective device |
WO2007112025A2 (en) * | 2006-03-24 | 2007-10-04 | Prescient Medical Inc | Composite vascular prosthesis |
EP3427766B1 (en) * | 2013-08-08 | 2020-09-23 | Boston Scientific Scimed, Inc. | Dissolvable or degradable adhesive polymer to prevent stent migration |
CN113520685A (zh) * | 2021-08-03 | 2021-10-22 | 上海微创医疗器械(集团)有限公司 | 用于血管的支架 |
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WO2023011222A1 (zh) * | 2021-08-03 | 2023-02-09 | 上海微创医疗器械(集团)有限公司 | 用于血管的支架 |
TWI822450B (zh) * | 2021-11-26 | 2023-11-11 | 大陸商上海微創心脈醫療科技(集團)股份有限公司 | 覆膜支架及覆膜支架系統 |
CN115154662A (zh) * | 2022-04-28 | 2022-10-11 | 南开沧州渤海新区绿色化工研究有限公司 | 一种兼具抗凝血和促进内皮化功能的人工血管及其制备方法 |
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