CN103025362A - 用由聚合物网眼细密型缠结物构成的包衣来包衣内假体 - Google Patents
用由聚合物网眼细密型缠结物构成的包衣来包衣内假体 Download PDFInfo
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Abstract
本发明涉及格子状或网状内假体,其具有连续的、不间断的和跨间隙的具有线缠物的包衣,其中该连续的、不间断的和跨间隙的包衣覆盖支柱以及各单独内假体支柱之间的间隙。
Description
本发明涉及用聚合物网眼细密型线缠物包衣的内假体以及该经包衣的内假体的制备和使用。
在全部体通道和体开口中以及在全部体通道和体开口处的血管壁的病理学变化和损伤可以导致这些通道的疼痛炎症、缩窄、阻塞、成囊和出血,从而使得中空器官的功能受限或甚至无效。一般地,血管壁的变性病症代表心肌梗死或卒中最常见原因中超过80%的情况。营养不良、作为流行病症的糖尿病或过度吸烟能够导致血管通道的病理学和动脉硬化变化,其还能够表现在腿动脉中,如果不经专业治疗则会导致坏死和最终切断受影响的肢端。
类似威胁生命的是动脉瘤的形成。这些是血管壁的成囊(Aussackungen),其能够回溯至结缔组织的先天弱点、动脉硬化、炎症或创伤,或者可以作为血管壁容量负荷的结果产生。在该上下文中,可提及伪动脉瘤(Aneurysma spurium),其也称为假动脉瘤。由此产生通过内膜和血管介质的破裂。这可以是钝伤或锐伤的结果,其出现在进行PTCA和/或支架植入的动脉穿刺之后比如在腹股沟动脉穿刺之后以及在心脏导管检查之后。可能的原因是在导管除去之后不足的压力,使得血管未正确封闭,从而导致进入围绕组织中的渗血。
影响体通道的另外一种且类似地频繁发生的危险是恶性和良性肿瘤的生长。快速和不受控的细胞分裂导致肿瘤在中空器官处以及其中的扩散,从而阻塞或封闭中空体通道。实例是食管癌,下咽癌,鼻咽癌和口咽癌,肠癌,肺癌,肾癌,胆管阻塞、胰阻塞和尿道阻塞等。空洞功能受损的进一步原因可以是囊肿和瘘管形成。
狭窄通常是指血管空洞的功能的物理阻塞或打断。再狭窄是复发的狭窄,其原因能够是对狭窄的初始治疗。
为了治疗窄缩的血液-携带体通道和为了治疗狭窄和再狭窄,与经皮经腔血管成形术(PTA)或经皮穿刺腔内冠状动脉成形术(PTCA)一起,近二十年来已证实支架的价值:作为永久留在体内的具有可能的局部活性剂治疗的内假体。在PTA或PTCA期间直接用气球导管将其植入并固定:在受影响场所扩展期间用气球导管,或者在受影响场所除去缩窄之后用粥样斑块切除术导管。处于扩展形式的支架向外挤压血管壁,使得受影响血管的天然血管直径得以重新构建并且血管保持开放。
然而,内假体的外来物质以及操作本身激起身体的保护性反应。在短时间内,内源防御系统通过不同途径对其反应:比如体液和特异性免疫反应,细胞过度增殖,血栓形成等,如果不采取其它缓和措施则会导致手术和治疗诱导的再狭窄。
继续开发内假体的努力所针对的是改善所用物质的生物可相容性,增加灵活性同时降低的物质疲劳并且减少外源表面,这至少在心血管和外周血管范围可以最小化外源表面诱导的再狭窄率的风险。
除内假体的最小化外源表面的基本要求之外,用生物可相容的、生物可降解的或生物稳定的物质包衣表面显得是有希望的进展,其大部分充当抗再狭窄活性剂的基质。该活性剂将根据要求通过时间和浓度-调节的活性剂释放来停止前-再狭窄过程,并且促进治愈过程,在理想情况下其相当于不存在外来影响下的治愈。本文中对内假体本身、包衣材料和活性剂以及它们的相互作用的要求都同样高。
相同骨架用于缓解、预防全部体通道中的狭窄,或用于尽可能长地阻碍威胁性梗阻(比如在治标医疗中或在疼痛治疗中),例如在食管,胆管,肠,肺,肾,尿道,胰,脑血管,气管(支气管),鼻旁窦和其它体空洞中。
于是,内假体的任务是停止过度、恶性、良性和/或干扰性组织的通常进入管腔中的生长,预防炎症,或者降低、预防或弥补中空血管的成囊风险。除了由支架引起的血管再狭窄,肿瘤生长、炎症和动脉瘤比如囊肿形成、瘘管、创伤和疤痕形成也是使用所述内假体的原因。与抗击动脉粥样硬化的血管支架相对照,向这些支架提供优选聚合物的衬垫覆盖整个圆柱形支架体包括支柱之间的间隙,其也作为有效的机械屏障并且应阻碍或至少延缓肿瘤通过间隙重新向内生长进入管腔。
对于体空洞中所用的全部外源物质所共通的是,它们确保最高可能的不受限的灵活性,也即靶标器官的生理学必需的未受打扰的、天然运动性,并且同时除去或延缓对迄今正常的导通性所产生的局部干扰。该灵活性取决于中空体的物质和设计,并且具有导致宽网眼的具有相对低的血管壁接触面积的网状结构。
根据症状和施用场所,考虑对植入物特性的不同要求。从而,对于用于植入动脉的内假体,存在与例如用于植入食管、胆管、气管、脑动脉、鼻旁窦、口咽、下咽等的内假体的不相同的要求。
用于治疗动脉硬化或狭窄和预防支架诱导性再狭窄的包衣以及未经包衣的血管支架具有尽可能小的外源表面,如目前可商购的产品所展示。
该领域中存在非常多的专利申请和专利。目前主要存在作为市场领导者的三种竞争支架。一方面是洗脱活性剂紫杉醇的聚合物包衣支架(Boston Scientific公司的Taxus支架),另一方面是洗脱活性剂雷帕霉素的聚合物包衣支架(Cordis Corp.的Cypher支架),以及洗脱西罗莫司衍生物依维莫司的支架Xience V(Abbott Vascular)。
虽然这些和其它冠状药物-洗脱支架(DES)的结果和经验是很有希望的并且代表对心血管领域再狭窄预防的正面贡献,但是并非全部问题都得以解决。例如,存在支架中再狭窄的现象比如晚期支架血栓形成(LST),以及最佳聚合物的发现。尽管已有良好结果,目前正进行对更佳活性剂的搜寻以便进一步降低再狭窄率以及晚期并发症。
肿瘤治疗所用的内假体能构成屏障的前提是其能完全覆盖受影响区域,也即全尺寸覆盖。这仅在表面最小化的内假体的间隙不再保持可通过的情况下是可能的,因为仅在该情况下屏障能够阻碍或防止肿瘤生长进入管腔。
由于聚合物包裹支架应以安全方式实现其适应作用场所的功能且在理想情况下应确保或支持,而不是负面影响或甚至干扰靶标器官未受影响的功能,过去已提出应为支架提供聚合物外壳的不同概念。
从而WO 93/22986A描述自扩展型食管支架,其在中央部分覆盖有机硅,并且压缩该部分使得支架具有比不含管的近端和远端部分更小的直径。近端和远端并未加以覆盖,使得可以通过游离支架支柱将支架更佳地固定至腔壁。但是,该支架并不成功,其原因是支架体的缩窄出现问题,例如在呕吐期间对支架的作用力增加,使得支架移动且用其游离支架端伤害食管壁。
进一步地,有机硅管能够在这些环境下撕裂或脱除,粘膜或食品颗粒能够沉积在血管壁与有机硅包衣之间,从而除了可能的炎症威胁以外对患者完全负面的情况可以变成现实。
WO 2005/030086描述类似的具有聚氨酯外壳的自扩展支架体的完整尺寸包衣方法,其中在用聚合物首先喷雾包衣支架之后,通过气球或又一适宜的空洞模板将聚合物从内部作为箔材施加于支柱。本文中,包衣从腔侧覆盖整个支架,从而在外侧支架支柱保持将支架稳定化在腔壁之中。随后将系统加热超过柔化温度使得聚氨酯结合至支架。出现的问题是,由于聚合物外壳并未定量或完全结合至包衣支架,并因此在给定环境下不能永久保持在支架上。类似地,通过加热可以形成小孔,其在植入情况下可以扩大并最终可以导致包衣材料的脱离,甚至整个支架的脱离。
另外,超过聚合物柔化温度的加热可以导致这样的情况:一方面,支架支柱的近腔表面上的包衣软化并侵入支柱之间的间隙,由此聚合物包衣不仅附着至支架,而且还附着至类似地由聚合物组成的气球,从而在膨胀期间包衣可以破裂或支架不与气球脱离。从而,在回收气球时,内部包衣具有粘着问题并且在气球从支架除去时至少部分脱除。作为结果,食品或粘膜能够沉积在脱除的包衣与内壁之间,其逐步使包衣从支架脱除,最主要的是阻碍未受打扰的通道。脱除物质进入腔中并导致额外的刺激,恶心或咳嗽,后者又支持甚至导致整个支架的脱离。目前,可商购的食管支架是ALIMAXX-ESTM,其是用平滑PU-聚合物外壳(作为箔材)完全包装的血管支持物。
施用支架-支柱间隙重叠式包衣支架的又一领域是最一般由支气管癌引起的气管狭窄领域,目前在工业化国家中其是发生率第二高的恶性肿瘤。这些肿瘤难以手术或通过多模式疗法治愈,从而约30%的患中央导气管狭窄的患者死于此病症。
该领域的特殊问题产生自气管的形状与其它中空通道相反并非圆形,从而这些支架中支架脱除和粘膜聚集在包衣支架与气管壁之间的风险特别高。在包衣于给定环境下从支架脱除而分泌物可以沉积支架和包衣之间时,出现相似的不利情况。在全部应用领域尤其是心血管领域中,对于全部包衣型血管支持物必须以相同程度考虑包衣脱离风险。
最一般地,仍然使用所谓的Dumont支架,其是管状有机硅管,配有特别开发用于气管区域的凸角以更佳固定于近腔侧;与大多数金属支架相比,其能够更容易地除去,原因是在通常发生的后续并发症时常常必需进行再植入。现今常常以完全尺寸包衣形式使用不同的可商购金属支架(例如Nitinol支架,Gianturco-和Wall支架),但是类似地其并未显示所希望的成功。
因为气管中的情况,外源体的移动仍旧是可改善的问题。除了固定不良以外,还存在不利地高的壁厚问题,例如在Dumont支架中,其阻碍分泌物沿内壁表面也即腔表面的流动。这导致分泌物的蓄积,其又会阻碍空气流,从而导致炎症且有利于病菌定殖。
这些″再狭窄″是通常发生的并发症。从而,不仅对冠状领域的常规药物-洗脱支架(DES)而且对全尺寸包衣产品即连贯包衣产品比如管来说都存在支架-诱导再狭窄风险,必须考虑包衣支架对例如支气管分泌的这种新阻塞或缩窄的实质风险,最终仅能通过手术将其作为粘稠胶状物除去。
阻塞或增加粘膜粘着的又一常见原因是腔支架表面的脱水,脱水的原因是不再提供天然内壁的身体调节的水分。但是,为了允许支气管分泌物流出又必需所述水分。支气管分泌物附着在该无水区域并不断蓄积,而呼吸的空气不能单独保持该部分的为了保持粘膜带来的天然平衡所必需的水分。因此,受影响的患者依赖用液体雾化器定期吸入以便尽可能久地延缓绝对会发生的分泌物梗阻。
又一且对令患者非常不快的社会问题是由病菌植入物表面原位定殖引起的极臭的呼吸,原因是在给定环境下病菌在这些场所的定殖不再能够得以避免。类似地,原因广泛的但也是支架植入的结果的局部发生炎症也是形成新阻塞的原因。
包衣某种箔材的支架的相同骨架能够用于治疗动脉瘤。动脉瘤的原因是血管壁的病理成囊,血液在其中聚集和凝结。血管壁由于重量负荷在该位置不断伸展,引起进一步的血流、淤塞和凝块。除增加的血栓形成威胁之外,这最终导致血管破裂。
US 5,951,599预期通过用小网眼的部分涂布的聚合物网络填充血管支架的自由间隙来解决该问题,其置于血管囊上方并且覆盖动脉瘤,从而使得囊中的血流停止。作为结果,其中形成稳定血栓,由此停止动脉瘤的扩大。此外,聚合物覆盖预防血栓或凝块的一部分溢出进入血液循环而导致其它部位的梗死。此处由于聚合物网络的低劣粘着也出现相同的问题,其使得支架失去功能并从而给患者带来增加的风险。目前,动脉瘤仍然通过用金属丝(″线圈″)填充来治疗,其停止囊内的血流。但是,在用于更长时间段的情况下,一般且必然使用的通至中空体器官的人工入口或人工出口是不足够的。疼痛的炎症和细菌的感染引起入口的频繁变化,并由此引起患者的并发症和额外的无法忍受且危险的应激。此处同样重要的是确保找到患者安全的解决方案。
本发明的目的是,提供包衣的内假体和在内假体具有间隙比如支架的情况下提供间隙-重叠式或间隙覆盖式包衣的内假体,其相同地避免对于全部体通道所描述的缺点包括冠状应用领域的缺点,并且尽管考虑施用位置的条件仍为所述植入物提供最佳的、一致的产生方法。
该任务通过本发明的独立权利要求技术教导得以解决。本发明的其它有利实施方式来自从属权利要求、说明书和实施例。
已发现现有技术的问题能够通过表面具有线缠物包衣的内假体得以解决。包衣优选是喷雾型线缠物。于是,本发明内假体具有用聚合物网眼细密型线缠物至少部分或完全包衣的表面。此外优选的是,线缠物包衣即线缠物的包衣超过内假体的端点,由此覆盖尖锐边缘或预防暴露的支柱区域。
线缠物包衣是柔性的,机械稳定的并且由聚合物物质组成,所述物质由线组成,而线是统计学且随机取向的、相互缠结和连接并且具有周围线形成的网眼。线缠物包衣的单条线由聚合物物质和尤其是本文提及的聚合物组成。这些聚合物优选具有高平均聚合度。
该线缠物能够作为包衣施用至全尺寸管状内假体比如膀胱导管、旁路导管和人工吻合口出口以及所谓的支架。支架理解为格子状或网状内假体。支架不形成大型管而是形成格子网络。例如,例如通过激光将支架从大型管切出,仅剩余单独的优选连接在一起的薄支柱。术语″支柱″如本文所用应理解为内假体骨架的单个固体片段(支架支柱)或在结点相互联接并由此形成内假体的可扩展且柔性的结构的支架。
在切割支架时,切出单个支柱之间的片段,其在本文中命名为″间隙″。从而,内假体具有构成内假体的多个固体骨架组分(例如环、螺旋、波浪和丝状的支柱),以及固体组分之间的多个间隙。在内假体的一般实施方式中,支柱在结点会聚,从而通过围绕的支柱和结点限定间隙。然而,存在这样的内假体实施方式,其不具有或几乎不具有结点,而支柱具有例如环或螺旋的形式。在所述内假体中,例如部分不再存在多个间隙而是仅有由例如两个纠缠螺旋限定的数个或仅一个间隙。然后,所述间隙并不完全受限,而是能具有一个或两个或更多个开口端或开口侧。总之,″间隙″是指固体内假体组分之间的开口或受限区域。
根据本发明的线缠物包衣间隙-重叠式地施用在支架上,也即间隙封闭性支柱所形成的间隙也得以包衣。从而,该包衣类似桥梁地跨过单个支柱的间隙,其仅链系在骨架、支柱和间隙处,而不位于固体基面。这样产生的衬垫可以是指整个圆柱形支架体或仅其所选区域。例如,根据适应症,可以包衣任选的近端或远端部分、中央区域、单个部分或纵向半侧包衣的支架以及这些区域的组合。包衣优选施用在外侧,也即背离管腔的一侧(近腔的)。但是,取决于适应症,朝向管腔侧也能够用聚合物网眼细密型线缠物包衣来进行包覆。也可能两侧均进行包覆。
术语″间隙-重叠″如本文所用也是指跨间隙的或覆盖间隙的,从而清楚的是,与其它包衣支架比较,该包衣不仅包围支架支柱而是全部包围整个支架。该能够特别良好地体现在图3和图7C中。图3显示包围支架的线缠物包衣,而支架支柱的腔金属表面能够通过撕开的部分观察。另外,能够观察到的是线缠物包衣并未包围单独的支架支柱,而是仅接近支架支柱的近腔表面以包裹整个支架。图7C显示线缠物包衣如何像纺织品包衣一样覆盖整个支架,并且可清楚辨认出从线缠物包衣内部轻微挤压的支架构造。
包衣用于一般也称为″导管″的全部体通道或体空洞的支持物,比如动脉,静脉,食管,胆管,肾管,鼻和口区域中的中空通道,气管,支气管,十二指肠部分,结肠或其它大致管状的体通道,其中内假体的该优选组具有格子状或网状结构,例如支架。本文术语″体通道″或″血管″不仅包括天然体通道或体通路,还包括人工体开口和体通道例如旁路和人工吻合口。从而,根据本发明的内假体包衣的其它应用是喉植入物,旁路,导管或人工吻合口和通常活有机体的体通道必须保持自由以及活动的全部区域,其中所述血管壁并未完全与管腔侧分离,从而确保在内血管壁与管腔之间的必需接触。在虑及管腔中的保持内腔表面健康所必需的重要物质的情况下,通过该方式预防腔壁从管腔分离。可渗透包衣允许对于保持在管腔与腔表面之间功能重要的物质的交换、运输和递送,所述物质是比如保持功能所必需的流体、水分、营养素或分子物质。由此,植入的外源体对环境的影响降低至最小。
根据靶标血管的相应需要,上述包衣内假体能够通过调整线直径、线长度、网眼数和网眼尺寸、孔径尺寸和孔形成,交联度和缠结物的丝间和最终丝内的渗透性来适应单独施用。
线缠物以及线缠物包衣由松散且随机安排的纤维或线组成,其由于混乱且随机的未组织结构难以分为单个纤维或线。从而,线缠物的稠度和线缠物包衣的强度(Festigkeit)取决于纤维的内在粘着和混乱、随机和未组织的结构。线缠物能够额外地固化的,为此可以使用不同方法比如温度、光线、水分和/或压力。固化的线缠物优选用作有机体中的包衣,原因是可以避免线脱离以及可导致的并发症。在本文中,线的相互粘着和固化在理想情况下已经在蒸发溶剂的干燥程序期间进行。在干燥程序之后,线缠物包衣是防撕裂的、可扩展的和可压缩的以及可卷曲的(也即能够装载于导管气球上)。还必须可以进行内假体灭菌(用热空气和蒸气热法灭菌,分步灭菌或用ETO、臭氧、甲醛、过氧化氢或过氧乙酸化学灭菌)而不影响线缠物的结构或渗透性,然而该方法必须适应内假体所用物质的特性。
根据本发明的线缠物是单独纤维或线的纺织品平面产品,其并非以特定构造相互交织、针织或编织或以其它方式连接或接合。与之相反,组织、针织和机织织物是由纱线和箔材膜按照某些规则原理和针织机理构成的。
与之相对,线缠物的纤维状包衣由位置仅能用统计方法描述的纤维或线组成。线,也称为纤维,是以混乱、无序和随机方式相互安排的。线之间的开口指定为网眼。
术语″网眼″如本文所用描述线缠物包衣的线之间的开口。开口不一定是圆形而能够呈任意形状,因为线缠物包衣的线是以随机方式取向并铺开的。所以,开口即网眼通常由数根线围绕。此外,网眼显示某种尺度分布。网眼的纵向直径理解为该开口的最大延伸,而横向直径是该开口的最小延伸。网眼的截面积理解为该开口也即围绕线以内的该网眼的面积。另外,网眼作为整体也具有平均纵向直径以及平均横向直径以及平均截面积。这些是上述定义参数在网眼整体中的平均值。单独网眼的数目、面积和直径的确定能够通过光谱方法完成。
在图4中可以观察到楔形网眼中央地排布(图4中间的深色区域,楔尖指向右方),其小于下层的肿瘤细胞(从网眼下方开始且朝下延伸的卵形和长伸展的浅色区域),从而肿瘤细胞不能通过线缠物包衣。
线缠物包衣的线具有1μm至30μm,优选1μm至20μm,还优选1μm至15μm,甚至更优选1μm至10μm且尤其优选2μm至7μm的平均线直径。
线缠物包衣的网眼具有0.01μm至1000μm,优选1μm至1000μm,还优选10μm至500μm,甚至更优选25μm至250μm和尤其优选50μm至150μm的平均直径。
线缠物包衣的网眼具有某些尺度分布,其中尺寸称为垂直观察各自网眼且由此获得的二维显示的各单独网眼的截面积。
根据本发明,内假体能够用线缠物包衣,线缠物由生物可降解的或生物稳定的优选线型聚合物或聚合物混合物组成。聚合物能够选自包含下述或由下述组成的组:
聚氨酯,聚对苯二甲酸乙二醇酯,聚氯乙烯,聚乙烯酯,聚乙烯缩醛,聚酰胺,聚酰亚胺,聚丙烯腈,聚醚,聚酯比如聚-3-羟基丁酸酯,聚-3-羟基烷酸酯/盐,聚氨基酸,聚糖,聚丙交酯,聚乙醇酸交酯,聚丙交酯乙交酯,脱乙酰壳聚糖,羧基烷基脱乙酰壳聚糖比如羧基甲基脱乙酰壳聚糖,胶原,聚磷腈,聚苯乙烯,聚砜,有机硅以及前述聚合物的衍生物、嵌段聚合物、共聚物和混合物。原则上,能够使用生物可相容的、非交联的和可溶于溶剂中的全部聚合物。
本发明从而涉及生物稳定的或生物可降解的内假体尤其是支架的包衣方法,但也涉及在体内保留更长时间段的其它假体和辅助物质的包衣方法,其中将它们用聚合物网眼细密型线缠物包衣。
从而,本发明也包括用于包衣扩展血管腔所用的内假体的方法,包括下述步骤:
a)提供内假体,
b)将聚合物溶于挥发性溶剂,
c)将基于聚合物的线缠物通过喷雾或电纺丝施用在内假体表面上。
除喷雾包衣之外,包衣也能够通过电纺丝、湿纺丝或熔融纺丝来进行。
至于溶剂,优选用于良好地溶解聚合物且是挥发性的那些溶剂。作为溶剂,优选使用高蒸气压的溶剂,比如丙酮,丁酮,戊酮,四氢呋喃(THF),苯,甲苯,轻石油醚,二甲基甲酰胺(DMF),二甲亚砜(DMSO),二甲苯,乙二醇,水,甲醇,乙醇,丙醇,氯仿,二氯甲烷,乙酸乙酯,正己烷,异丙醇,苯酚或其混合物。
在本发明方法中,线自身会引起线缠物线的堵塞,也即仅通过喷雾溶液产生的具有仍然粘着潮湿表面的线在接触时相互附着,本文也能够将不是粘合剂或至少不必须是粘合剂的添加剂比如活性物质掺入线缠物。从而,不需要会显著修饰线表面的额外粘合剂、交联步骤或交联剂。相反地,线缠物的线通过由于存在溶剂而仍然粘性的线在接触点相互粘合,从而产生根据本发明的线缠物。因此,不需要会覆盖纤维表面而使得纤维特异性效果不会发展的外来粘合剂。通过仅在相互粘合的纤维的交联点上自身施加的线缠物内聚力,线缠物结构还显示更佳的有利于吸收流体和水分的毛细管特征。喷雾溶液形成线能够优选通过压缩空气喷嘴进行。线缠物的结构和线直径能够通过物质压力、喷嘴出口的变化,在内假体与喷嘴之间的距离以及通过聚合物浓度来改变。由于线仅在接触点粘合,整个线缠物包衣更具柔性和移动性,从而避免在膨胀期间的线缠物包衣破裂。
线缠物包衣能够优选扩展其长度的多至10%,而不存在裂痕;更优选其长度的多至100%,更优选其长度的多至200%,尤其优选扩展其长度的多至400%,而不存在裂痕。
本发明内假体的线缠物包衣优选具有定义为空气渗透率的孔隙率:在1.2kPa的压力差下,1至150ml[1至150ml/(cm2*60s)],更优选10至100ml[10至100ml/(cm2*60s)],特别优选20至50ml空气每平方厘米每分[ml/(cm2*60s)]。
本发明内假体的线缠物包衣优选具有定义为水渗透性的孔隙率:100至300ml/cm2*min,特别是150至250ml/cm2*min(ml水每平方厘米每分,Δp=120mmHg)。根据Wesolowski’s方法于120mm Hg测量来确定这些水渗透性值。本发明内假体的特征优选在于,本发明线缠物具有网眼且由多孔线组成。
这些特征能够根据需要加以使用和调节,从而能够适应所用聚合物物质和所得包衣内假体的必需且多样的模式。除所用聚合物或聚合物混合物之外,关键参数是线直径、线孔隙率、变化的包衣厚度、网眼截面、喷雾技术和溶剂等。尽管包衣程序相同,这些高度变化的可能性确保提供这样的内假体,其最佳且单独地适应全部已知血管病。例如,线缠物包衣能够以上述方式实现,使得肿瘤细胞不可能从线之间侵入内管腔(参见图4)。另外,由于网眼的可调节尺寸促进向内表面进一步提供所需水分,该包衣模式防止中空器官的腔表面的例如干燥,原因是线缠物包衣并不像连续的不可渗透箔材那样将中空器官或体通道的内部表面与内假体内部管腔分离,而是仅排除较大颗粒或癌细胞的通过,但不排除液体、水或空气的渗透。具有聚合物膜状全尺寸包衣的支架恰恰显示上述缺点,其阻碍了水分或空气的交换。相反,根据本发明的包衣支架允许在血管壁与管腔之间的必需交换过程,并且确保所支撑的内部血管壁区域并不与必需的过程和/或物质分离开,从而最佳地支持治愈过程。根据应用场所,内源的杀菌过程能够预防或减少有问题的病菌生长。
根据应用领域,可以用亲水聚合物支持本发明包衣支架的进一步腔侧包衣。
类似地,对于比如气管支架还可以希望平滑腔表面,从而确保粘膜的流动。在将本发明包衣施用在内假体上期间,这能够容易地实现:该内假体装载于适应内假体直径的圆柱形金属核心上,从而没有线能够突出进入管腔,但仍完美形成腔以及近腔的线缠物结构。为了更容易地将喷雾包衣的内假体与金属核心脱离,最终可能必需用溶剂润湿内侧或将具有润滑的预包衣支架支柱的支架用于包衣。
在进一步优选的实施方式中,使用或根据本发明施用线缠物,其还含有至少一种抗增殖剂,抗迁移剂,抗血管生成剂,抗炎剂,抗再狭窄剂,消炎剂,细胞生长抑制剂,细胞毒素剂和/或抗血栓形成剂。该活性剂能够以共价结合形式或呈粘着或离子结合形式包括。获得的由此包衣的医学产品也即内假体,其含有线缠物包衣中的至少一种活性剂,优选呈药物-释放包衣(药物释放系统)形式。线缠物包衣能够这样制备:将活性剂或活性剂混合物溶于喷雾溶液,然后施用喷雾溶液以制备线缠物包衣,或者在制备线缠物包衣之后向其施涂。
本文中有利的是,活性剂或活性剂混合物从本发明线缠物包衣中的释放不仅对于一般支架在支架支柱处发生,而也在植入本发明包衣内假体的整个患病区域发生。与之目前可商购的仅用活性剂在支柱区域包衣的药物洗脱支架相反,上述有利特征可以向患病位置全面提供必需的弥补并且不仅准确治疗受影响位置,甚至还治疗接近损伤的区域。类似地,与常规支架的支柱的均匀包衣相比较,由于粘着得到促进,相当粗的线缠物质地有助于新细胞在受伤区域定殖。
具有本发明的聚合物网眼细密型线缠物包衣的内假体具有下述优势:
1.包衣方法可通用于下述领域:血管内假体以及人工体通道比如人工吻合口出口、膀胱导管、静脉导管;简言之,较长时间地用于在体表或体内必需的全部人工入口和出口;并且通过选择聚合物物质、活性剂的加入和可调节的过程参数比如线的网眼尺寸或孔径尺寸来单独适应不同条件。
2.线缠物覆盖损伤区域中体通道所产生的不平坦,从而提供显著和必需的保护,例如在来自在损伤区域中的凝血细胞附件的血管支架情况下,由此显著抑制对带来威胁生命的止血的活化凝血细胞引发的凝结级联。
3.血管壁的损伤区域基本上通过线缠物包衣保护隔离在腔内的活动,从而治愈过程能够以最佳方式发生。
4.聚合物网眼细密型线缠物包衣提供损伤区域中的体通道的额外稳定性。
5.聚合物网眼细密型线缠物包衣充当对抗过度增殖、肿瘤生长、新瘘管形成和成囊以及外部出血的机械屏障。
6.经由仍然可渗透的线缠物结构,在管腔与血管壁之间的至少最低接触得以保持,从而最必需要求比如营养素、水分、氧的渗透等是可能的,尽管受到限制。
7.线缠物包衣的纹理表面提供血管壁中的内假体的额外支持。
8.聚合物网眼细密型线缠物包衣提供所加活性剂在整个受影响区域的合理均匀分布。
9.聚合物网眼细密型线缠物的线缠物包衣的显著更大的表面允许施用增加的量的活性剂。
10.通过聚合物网眼细密型线缠物包衣的显著更大的表面,也能够给予仅在某些剂量导致成功治疗的那些活性剂,上述成功治疗是仅支柱包衣不能实现的。因此,本发明包衣能够以最简单方式拓宽适宜活性剂的选择。
11.活性剂能够随喷雾溶液直接混入用于形成线缠物的聚合物中。
12.活性剂能够在填充线缠物的线形成的网眼之后引入。
13.活性剂用不同速度洗脱。
14.活性剂能够相互局部分开,一方面在多孔或生物可降解的聚合物纤维中,而另一方面在形成线缠物的线之间。
15.尽管局部分离,活性剂在整个内假体的分布绝对均匀。
16.能够局部分开引入不同活性剂,两者仍然均匀分布且在整个治疗区域洗脱。
17.上述包衣内假体的腔侧能够根据需要是平滑、包衣或未经包衣的,含或不含活性剂。
18.聚合物网眼细密型线缠物的包衣以及质地提供比普通(仅在支柱上)包衣内假体显著较大的表面,用于最多样的体通道血管壁损伤的治疗途径。
19.聚合物网眼细密型线缠物包衣的部分施用允许对患病位置的特定治疗,例如从一侧生长进入管腔的肿瘤能够用仅在该侧包衣的支架停止的。内假体的对侧保持开放或仅在支柱上包衣。该变型也良好地适于动脉瘤的治疗。
20.线缠物形成的孔不仅能用活性剂填充,如果需要还能用其它物质和赋形剂填充,其在短时间之后与活性剂一起洗脱或降解。快速降解的聚合物可以用作活性剂载体和洗脱控制物,以及活性剂转移加速剂、所谓的运输介导物或介导物。
最后,在充足的、优选时间限制性的稳定性的情况下,聚合物网眼细密型线缠物包衣还能够甚至不与内假体一起使用。出于该意图,任选地含有活性剂的线缠物直接喷雾在塑形核心上。除支架之外,还能够包衣连续的、全尺寸的和管状的内假体。因此,将任选地含有活性剂的线缠物直接施用至内假体(例如在膀胱导管的情况下)或运输单元。内假体暂时保持在有机体中,比如用线缠物包衣且例如配有抗菌或抗炎活性剂的膀胱导管或静脉导管能解决或至少显著改善许多使用持久导管的患者的问题。
作为可降解或生物可降解的内假体的包衣的上述线缠物能在预设时间之后于受控条件下缓慢降解,而不存在任意长期的例如伴随非可降解内假体的并发症。
类似地,生物稳定的或生物可降解的线缠物可用于生物可降解的支架。取决于应用领域,生物可降解的线缠物还能够有利地位于可移除的植入物上,例如在生物可降解的线缠物降解之后除去内假体。包衣和内假体还能够构造为生物可降解的。在该情况下,使用活性剂也可以是合理的。
自然地,必须确保聚合物网眼细密型线缠物的包衣不释放能导致生命威胁情况的任意片段或颗粒。
当然,也可能以分开的包衣步骤将至少一种活性剂直接涂布在内假体表面,由此在线缠物包衣下,或在线缠物包衣上,或者在线缠物包衣以下和以上。
活性剂浓度优选为0.001-500mg每平方厘米包衣内假体表面,也即表面按本发明线缠物包衣的总表面来计算。
根据包衣方法,一种或多种活性剂能够位于线缠物包衣下、线缠物包衣中和/或线缠物包衣上。能够优选用作抗增殖剂,抗炎剂,抗迁移剂,消炎剂,抗血管生成剂,细胞生长抑制剂,细胞毒素剂,抗再狭窄剂,抗成瘤剂,抗菌剂和/或抗霉菌剂的是:
阿昔单抗,阿西美辛,乙酰维斯米亚酮(Acetylvismion)B,阿柔比星,腺苷蛋氨酸,阿霉素,七叶素,阿佛洛莫生,东非马钱碱,阿地白介素,胺碘酮(Amidoron),氨鲁米特,安吖啶,阿那白滞素,阿那曲唑,银莲花素,氨基蝶呤,抗真菌药,抗血栓药,毒毛旋花甙元,阿加曲班,马兜铃内酰胺-AII,马兜铃酸,子囊霉素,天冬酰胺酶,阿司匹林,阿托伐他汀,金诺芬,硫唑嘌呤,阿奇霉素,浆果赤霉素,巴弗洛霉素,巴利昔单抗,苯达莫司汀,苯佐卡因,小檗碱,桦木醇,桦木酸,银杏酚,双银胶菊内酯(Bisparthenolidin),博来霉素,Bombrestatin,乳香脂酸及其衍生物,鸦胆子酚A、B和C,环落地生根素A,白消安,抗凝血酶,比伐卢定,钙粘蛋白,喜树碱,卡培他滨,邻-氨基甲酰基-苯氧基-乙酸,卡铂,卡莫司汀,塞来考昔,千金藤素,西立伐他汀,CETP抑制剂,苯丁酸氮芥,磷酸氯喹,毒芹素,环丙沙星,顺铂,克拉屈滨,克拉霉素,秋水仙碱,伴刀球霉素,香豆定,C-型利尿钠肽(CNP),拓树异黄酮A,姜黄素,环磷酰胺,环胞素A,阿糖胞苷,达卡巴嗪,达克珠单抗,放线菌素D,氨苯砜,柔红霉素,双氯芬酸,1,11-二甲氧基铁屎米-6-酮,多西他赛,多柔比星,道诺霉素,表柔比星,爱波喜龙A和B,红霉素,雌莫司汀,依托泊苷,依维莫司,非格司亭,氟尿嘧啶,氟伐他汀,氟达拉滨,氟达拉滨-5′-二氢磷酸酯,氟尿嘧啶,多叶霉素,磷雌酚,吉西他滨,Ghalakinosid,银杏酚,银杏酸,糖苷1a,4-羟基氧基环磷酰胺,伊达比星,异环磷酰胺,交沙霉素,拉帕醇,洛莫司汀,洛伐他汀,美法仑,麦迪霉素,米托蒽醌,尼莫司汀,匹伐他汀,普伐他汀,丙卡巴肼,丝裂霉素,甲氨蝶呤,巯嘌呤,硫鸟嘌呤,奥沙利铂,伊立替康,托泊替康,羟基脲,米替福新,喷司他丁,培门冬酶,依西美坦,来曲唑,福美坦,米托蒽醌,麦考酚酸莫酯,β-拉帕醌,鬼臼毒素,鬼臼酸2-乙基酰肼,莫拉司亭(rhuGM-CSF),聚乙二醇化干扰素α-2b,来格司亭(r-HuG-CSF),聚乙二醇,选择素(细胞因子拮抗剂),细胞激动素抑制剂,COX-2抑制剂,血管肽素,抑制肌肉细胞增殖的单克隆抗体,bFGF拮抗剂,普罗布考,前列腺素,1-羟基-11-甲氧基铁屎米-6-酮,东莨菪亭,NO供体,季戊四醇四硝酸酯和斯德酮胺(Syndnoeimine),S-亚硝基衍生物,他莫昔芬,星孢素,β-雌二醇,α-雌二醇雌三醇,雌酮,炔雌醇,甲羟孕酮,环戊丙酸雌二醇,苯甲雌二醇,曲尼司特,尾叶香茶菜丙素(Kamebakaurin)和癌症治疗中所用的其它萜类化合物,维拉帕米,酪氨酸激酶抑制剂(酪氨酸磷酸化抑制剂),紫杉醇及其衍生物,-α-羟基-紫杉醇,紫杉特尔,莫非布宗,氯那唑酸,利多卡因,酮洛芬,甲芬那酸,吡罗昔康,美洛昔康,青霉胺,羟氯喹,金硫丁二钠,奥沙西罗,β-谷甾醇,麦替卡因,聚多卡醇,诺香草胺,左薄荷脑,玫瑰树碱,D-24851(Calbiochem),秋水仙胺,细胞松弛素A-E,Indanocine,Nocadazole,杆菌肽,玻连蛋白受体拮抗剂,氮斯汀,胍基环化酶刺激物金属蛋白酶-1和-2的组织抑制剂,游离核酸,掺入核酸的病毒传递物,DNA和RNA片段,纤溶酶原活化剂抑制剂-1,纤溶酶原活化剂抑制剂-2,反义寡核苷酸,VEGF抑制剂,IGF-1,抗生素类活性剂,头孢羟氨苄,头孢唑林,头孢克洛,头孢西丁,妥布霉素,庆大霉素,青霉素类,双氯西林,苯唑西林,磺酰胺类,甲硝唑,依诺肝素,肝素,水蛭素,PPACK,精蛋白,尿激酶原,链激酶,华法林,尿激酶,血管扩张剂,双嘧达莫,曲匹地尔,硝普盐,PDGF拮抗剂,三唑并嘧啶,Seramin,ACE抑制剂,卡托普利,西拉普利,赖诺普利,依那普利,氯沙坦,硫蛋白酶抑制剂,前列环素,伐哌前列素,干扰素α、β和γ,组胺拮抗剂,5-羟色胺阻断剂,细胞凋亡抑制剂,细胞凋亡调节剂,卤夫酮,硝苯地平,对乙酰氨基酚,右泛醇,氯吡格雷,乙酰水杨酸衍生物,链霉素,新霉素,新霉素B,巴龙霉素,核糖霉素,卡那霉素,阿米卡星,阿贝卡星,卡那霉素B,地贝卡星,大观霉素,潮霉素b,硫酸巴龙霉素,奈替米星,西索米星,异帕米星,甲基姿苏霉素,阿司米星,安普霉素,遗传霉素,阿莫西林,氨苄西林,巴氨西林,匹美西林,氟氯西林,美洛西林,哌拉西林,阿洛西林,替莫西林,替卡西林,阿莫西林,克拉维酸,氨苄西林,舒巴坦,哌拉西林,三唑巴坦,舒巴坦,头孢孟多,头孢替安,头孢呋辛,头孢甲肟,头孢地嗪,头孢哌酮,头孢噻肟,头孢他定,头孢磺啶,头孢曲松,头孢平,头孢匹罗,头孢西丁,头孢替坦,头孢氨苄,头孢呋肟酯,头孢克肟,头孢泊肟,头孢布烯,亚胺培南,美罗培南,厄他培南,多利培南,氨曲南,螺旋霉素,阿奇霉素,泰利霉素,Quinopristin,达福普汀,克林霉素,四环素,脱氧土霉素,米诺环素,甲氧苄啶,磺胺甲基异噁唑,磺胺美曲,呋喃妥因,洛美沙星,诺氟沙星,环丙沙星,氧氟沙星,氟罗沙星,左氧氟沙星,司帕沙星,莫西沙星,万古霉素,替考拉宁,利奈唑胺,达托霉素,利福平,夫西地酸,磷霉素,氨丁三醇,氯霉素,甲硝唑,多粘菌素E,莫匹罗星,杆菌肽,新霉素,氟康唑,伊曲康唑,伏立康唑,泊沙康唑,两性霉素B,5-氟胞嘧啶,卡泊芬净,阿尼芬净,生育酚,曲尼司特,吗多明,茶多酚,表儿茶素没食子酸酯,表没食子儿茶素没食子酸酯,来氟米特,依那西普,柳氮磺吡啶,依托泊苷,双氯西林,四环素,曲安西龙,突变霉素,普鲁卡因胺,视黄酸,奎尼丁,丙吡胺,氟卡尼,普罗帕酮,索他洛尔,天然和合成获得的类固醇,桦褐孔菌醇(Inotodiol),Maq uirosid A,Ghalakinosid,Mansonin,Streblosid,氢化可的松,倍他米松,地塞米松,非甾族物质(NSAIDS),非诺洛芬,布洛芬,吲哚美辛,萘普生,保泰松,抗病毒剂,阿昔洛韦,更昔洛韦,齐多夫定,克霉唑,氟胞嘧啶,灰黄霉素,酮康唑,咪康唑,制霉菌素,特比萘芬,抗原生动物剂,氯喹,甲氟喹,奎宁,天然萜类化合物,马栗树皮苷(Hippocaesculin),玉蕊皂甙元-C21-angelat,14-脱氢剪股颖酯,翦股颖克灵(Agroskerin),剪股颖酯(Agrostistachin),17-羟基剪股颖酯,Ovatodiolide,4,7-氧基环防风酸,类燕茜素B1、B2、B3和B7,土贝母皂苷,抗痢鸦胆子甙C,鸦胆子苷(Yadanzioside)N和P,异去氧地胆草素,白花地胆草内酯(Tomenphantopin)A和B,甘油茶碱A、B、C和D,熊果酸,山香酸(hyptatic acid)A,异-德国鸢尾醛,变叶美登木醇(Maytenfoliol),艾佛散宁A,香茶菜甲素A和B,长栲利素B,黄花香茶菜素C,Kamebaunin,Leukamenin A和B,13,18-脱氢-6-α-Senecioyloxychaparrin,美丽红豆杉素A和B,Regenilol,雷公藤甲素,磁麻苷,Hydroxyanopterin,原白头翁素,白屈菜红碱(Cheliburin)氯化物,中国木防己碱(Sinococulin)A和B,二氢光花椒碱,氯化光花椒碱,12-β-羟基孕二烯-3,20-二酮,堆心菊灵,大尾摇碱,大尾摇碱-N-氧化物,毛果天芥菜碱,桦褐孔菌醇(Inotodiol),鬼臼毒素,爵床脂素A和B,Larreatin,Malloterin,Mallotochromanol,异丁酰梧桐色满醇,Maquirosid A,地钱素(Marchantin)A,美坦生,石蒜西定(Lycoridicin),石蒜西定(Margetin),水鬼蕉碱(Pancratistatin),鹅掌揪碱,双银胶菊内酯(Bisparthenolidin),氧化黄心树宁碱,杠柳苷A,熊果酸,脱氧普梭草素,Psycorubin,蓖麻毒素A,血根碱,马武小麦酸(Manwu wheat acid),甲基珍珠梅苷,Sphatheliachromen,刺叶素(Stizophyllin),Mansonin,Streblosid,Dihydrousambaraensin,羟基乌撒巴林,马钱子碱五氨合物,Strychnophyllin,乌撒巴林,乌桑巴拉碱(Usambarensin),鹅掌揪碱,氧化黄心树宁碱,西瑞香素,落叶松树脂醇,甲氧基落叶松树脂醇,丁香树脂酚,西罗莫司(雷帕霉素)及其衍生物比如Biolimus A9,依维莫司,Myolimus,Novolimus,吡美莫司,Ridaforolimus,脱氧雷帕霉素,他克莫司FK 506,坦罗莫司和唑罗莫司,生长抑素,他克莫司,罗红霉素,醋竹桃霉素,辛伐他汀,罗苏伐他汀,长春碱,长春新碱,长春地辛,替尼泊苷,长春瑞滨,曲磷胺,曲奥舒凡,替莫唑胺,塞替派,维A酸,螺旋霉素,伞形酮,脱乙酰维斯米亚酮(Desacetylvismion)A,维斯米亚酮(Vismion)A和B,泽渥萜和含硫氨基酸比如胱氨酸以及前述活性剂的盐,水合物,溶剂化物,对映体,外消旋体,对映体混合物,非对映体混合物;代谢物,前药和混合物。
线缠物包衣或线缠物包衣的网眼可以用可吸收的或在使用条件下耐性的防水层密封。这些还能够含有控释的活性剂。另外,线缠物形成的网眼能够用可吸收的聚合物或低聚物或粘稠物质填充,其含有活性物质或本身是活性物质。
另外,在用线缠物包衣步骤之前的步骤中,可将血液相容层固定化在表面上,优选以共价方式结合在未经包衣的内假体表面,或者用例如戊二醛交联。在未经包衣的支架物质可以与血液接触情况下,并未活化血液凝结的上述层是合理的。因此,优选首先用该内部的血液相容层装配部分包衣的支架。另选地,也能将外部、任选血液相容的层施用在线缠物包衣上。″内部″层或包衣是指直接施用在支架表面的层或包衣。″外部″层或包衣是指顶部或离支架表面最远的层或包衣。
优选血液相容层制备自下述优选物质:天然来源的肝素以及区域选择性制备的不同硫化和乙酰化度的衍生物,其分子量范围是带来抗血栓效果的戊聚糖的分子量范围至可商购肝素的约13kD的标准分子量的分子量范围,类肝素硫酸盐及其衍生物,红细胞二醇盏(Erythrocytenglycolcalix)的寡糖和聚糖,低聚糖,聚糖,完全脱硫的和N-再乙酰化的肝素,脱硫的和N-再乙酰化的肝素,N-羧基甲基化的和/或部分N-乙酰化的脱乙酰壳聚糖,聚丙烯酸,聚醚醚酮(Polyetheretherketone),聚乙烯吡咯烷酮和/或聚乙二醇以及这些化合物的混合物。
本发明方法适用于下述的包衣:例如内假体,特别是支架比如冠状支架,血管支架,气管支架,支气管支架,尿道支架,食管支架,胆管支架,肾支架,小肠支架,结肠支架,大脑支架,咽支架,周围支架和其它支架。此外,能够根据本发明包衣螺旋线、导管、插管、管、导线以及一般管状的或管式的植入物或前述医学产品的一部分。
内假体和特别是支架可以由常用物质组成,比如医用不锈钢,钛,铬,钒,钨,钼,金,铁,钴-铬,镍钛诺(Nitinol),镁,铁,前述金属的合金以及生物可再吸收的金属和金属合金比如镁,锌,钙,铁等,以及聚合物物质,优选可吸收的聚合物物质比如脱乙酰壳聚糖,类肝素,多羟基丁酸酯(PHB),聚甘油酯,聚丙交酯和上述提及化合物的共聚物。导管能够制备自常用物质中任一种,尤其是聚合物比如聚酰胺,聚醚,聚氨酯,聚丙烯酸类,聚醚和其它聚合物。
包衣的医学产品特别用于保持整个身体包括脑、鼻、十二指肠、幽门、小和大肠中的全部管状结构开放,比如尿道,食道,气管,胆管,肾管,血管,但还用于保持人工出口开放,比如用于肠道或气管,以及用于长期需要的人工入口和出口开放。
因此,包衣的医学产品适于预防、减少或治疗狭窄,再狭窄,支架中再狭窄,动脉硬化,动脉粥样硬化,肿瘤,瘘管形成,成囊,动脉瘤,周围组织出血和血管阻塞、血管缩窄、血管膨胀和通道或出口或人工入口和出口损伤的全部其它形式。
本发明的进一步实施方式涉及具有合成型聚合物多孔壁的内假体,其中微粒包埋在表面上固定化血液凝结抑制剂的假体壁中。血液凝结抑制剂优选经由所谓的连接体(间隔物分子)固定化在微粒表面。一般地,连接体并非共价地,但优选吸附性地结合至微粒。血液凝结抑制剂优选共价结合至连接体。共价键合通常基于在连接体官能团与抑制剂的适宜反应性基团例如羟基和/或氨基之间的化学缩合反应。通过与连接体键合,血液凝结抑制剂与微粒有一定距离。由此,抑制剂的活性损伤能够得以广泛地避免。连接体-抑制剂缀合物在微粒表面的固定化优选是基于吸附,特别是在连接体与微粒表面之间的静电相互作用。
在其它优选的实施方式中,连接体是聚合物分子,方便地具有线性结构。优选,这些连接体是寡或聚亚烷基二醇,尤其是聚乙二醇(PEG)。血液凝结抑制剂优选是丝氨酸蛋白酶抑制剂,尤其是凝血酶抑制剂。凝血酶是血浆凝血的关键酶,其将纤维蛋白原裂解为单体纤维蛋白。随后,其将附着在血管内壁的血液组分聚合并交联为血栓。
附图说明
图1显示部分预扩展支架周围的PLGA线缠物,其已在用线缠物包衣之后卷曲并扩展。能够容易地辨认出PLGA外壳保持完好。
图2显示具有微孔(d=200μm;d表示平均孔径)的线缠物包衣的支架。
图3显示,与图1和2比较,未预扩展的内假体,其在卷曲和扩展尝试之后崩开的PLGA线缠物包衣。将支架过度延伸以使线缠物包衣破裂,使得可以良好观察线状包衣结构。在生理学条件下,上述支架过度延伸不会发生,从而并无线缠物包衣破裂的危险。
图4显示肿瘤细胞由于其尺寸无法穿透至线缠物包衣的另一侧。
图5显示在不锈钢纱布上通过喷雾方法制备的PU-纤维网络或纤维缠结物的REM-图片(1000x放大率)。白色圆圈等于大约5μm,其提供对纤维直径的认识。在喷雾过程期间通过重叠纤维的胶结形成平坦区域。对于两种物质,最小孔的估计孔径尺寸为2至5μm(在10k-图片中估计,根据小圆圈等于大约5μm)。该物质内和外表面的结构并无本质不同。
图6显示在不锈钢纱布上通过喷雾方法制备的PU-纤维网络或纤维缠结物的REM-图片(800x放大率)。在喷雾过程期间通过重叠纤维的胶结形成平坦区域。对于两种物质,最小孔的估计孔径尺寸为2至5μm(在10k-图片中估计,根据小圆圈等于大约5μm)。该物质内和外表面的结构并无本质不同。
图7显示不同包衣阶段的内假体。A)在包衣之前的内假体,水平装载于包衣装置的棒上;B)包衣内假体,水平装载于包衣装置的棒上;C)包衣内假体。
实施例
实施例1:用聚合物预包衣内假体的支柱
用0.5%PLGA溶液喷雾-包衣内假体支柱。出于该目的,将支架水平悬挂在已插入旋转且顺向进料装置的旋转轴的细金属棒上,旋转轴以所定义旋转速度旋转。在所定义的顺向进料幅度、旋转速度和所定义在支架与喷嘴之间的距离,用喷雾溶液来喷雾支架。在室温下干燥并储存在排气罩中过夜之后,再次称量。支架支柱或内假体支柱的预包衣提供线缠物对支柱的更佳粘着。
实施例2:用含抗增殖活性剂的聚合物内假体支柱的进行表面全尺寸预包衣
喷雾溶液:145.2mg PLGA或聚砜和48.4mg雷帕霉素或雷帕霉素(量20%-90%)与一种或多种其它活性剂比如紫杉醇、环胞素A、沙利度胺、fusadil等的相应活性剂组合的33%喷雾溶液,用氯仿充至22g。
如实施例1的描述,将该喷雾溶液施用于支架上。
所用支架可以是裸支架、血液相容包衣的支架和/或通过喷雾或浸渍方法用活性剂层包衣的支架。
仅用于包衣支柱的喷雾溶液通常具有与下述线缠物喷雾包衣不同的又一活性剂。
实施例3:用含抗细菌活性剂的聚合物将内假体预包衣在经尿道或耻骨弓上导管的实施例上
溶液:144.5mg PVP以及相应的抗细菌剂和抗真菌剂活性剂组合(例如红霉素和特比萘芬3∶1 w∶w)的32%喷雾溶液,用氯仿充至22g。
根据喷雾方法(也可能是浸渍方法),将该喷雾溶液全尺寸地、均匀地且无间隙地施用至实施例1描述的表面。
实施例4:用PLGA线缠物全尺寸或支柱间隙重叠式全尺寸地包衣内假体
在干燥之后,在与实施例1相同的喷雾包衣装置上,将部分预扩展内假体用含3%氯仿的PLGA溶液喷雾,以便涂布致密的水分可渗透的线缠物。
实施例5:用平滑内壁和外表面上的PU-线缠物包衣产生全尺寸或支柱间隙重叠式全尺寸的线缠物包衣内假体
将内假体牢固地装载于抛光的不锈钢棒上,浸入粘稠的聚氨酯(PU)THF溶液(约16%)(例如Avansource Biomaterials Inc.的Chronoflex C65D)。
然后在稍干燥的表面上,通过喷雾装置(例如Chronoflex C 80A)用6%PU的THF溶液施用均匀的线缠物层。
在干燥之后,从金属棒仔细地除去线缠物包衣支架。
实施例6A:置于气球导管上的内假体的线缠物包衣
预处理的支架卷曲在气球导管上,随后根据实施例2用5%PLGA(Evonik的Resomer RG504H,固有粘度为0.54dl/g)的氯仿喷雾溶液进行全尺寸包衣。
实施例7A:用PDLG-线缠物进行支架的支柱间隙重叠式全尺寸包衣
仅用0.5%PDLG-溶液(PURAC的Purasorb PDLG 5010,固有粘度为1.03dl/g),将各10个支架预喷雾在支柱上,该预包衣确保线缠物对支柱的更佳粘着。在干燥之后,用3%PDLG-溶液喷雾支架,以涂布致密的线缠物。将包衣喷雾在支架的右边缘和左边缘,从而转折点位于支架以外。
在气球导管上卷曲并扩展至4mm直径之后,在非预扩展支架上的PLGA-线缠物包衣以及100%预扩展支架的包衣发生破裂。在卷曲和扩展期间,50%预扩展支架的PDGL-线缠物包衣保持不变。在不加惰性气氛贮藏5天之后,50%预扩展支架的包衣的功能保持不变。
实施例6B:用脱硫的再乙酰化的肝素进行内假体的血液相容性包衣
将医学不锈钢LVM 316制成的非扩展支架,用丙酮和乙醇在超声浴中去脂15分钟,在干燥箱中于100℃干燥。随后,将它们浸入2%的3-氨基丙基三乙氧基硅烷的乙醇/水混合物(50/50(v/v))溶液,持续5分钟,然后在100℃干燥5分钟。随后在脱矿质水中洗涤支架过夜。
在4℃,将3mg脱硫和再乙酰化的肝素溶于pH 4.75的30ml 0.1MMES缓冲剂(2-(N-吗啉代)乙磺酸),加入30mg N-环己基-N’-(2-吗啉代乙基)碳二亚胺-甲基-对甲苯磺酸酯。在4℃,将支架在该溶液中搅拌15小时。随后用水、4M NaCl溶液和水各冲洗2小时。
实施例7B:用聚氨酯线缠物包衣的内假体的血液相容性包衣
可将与实施例6B和3所示的血液相容性包衣相同的方法用于线缠物例如PU线缠物,由此在全部内假体上产生具有表面血液相容性的线缠物。
实施例8:以聚氨酯为例制备具有平滑的内壁和喷雾的外壁的内假体
将抛光的不锈钢棒用作浸渍/喷雾过程的载体物质,用于制备聚氨酯血管假体。
最初,将金属棒浸渍于粘稠的PU(例如Carbothane PC-3575A)的THF溶液中,以获得平滑内壁。随后,将6%聚氨酯-THF-溶液喷雾在预包衣的金属棒上。在干燥之后,在60℃于SDS-溶液浴中温育内假体30分钟,然后将其自金属棒脱除。所获得的内假体具有1mm的壁强度
壁强度可通过喷雾过程进行调节。壁强度的希望范围是优选1至1.5mm。内假体的直径和长度是可变的,并且取决于不锈钢棒的直径和长度。
实施例9:用混有表面活性剂混合物(吐温20)的聚碳酸酯聚氨酯的线缠物包衣内假体
为了喷雾-线缠物,制备1.5%至6%聚碳酸酯聚氨酯的THF溶液,其中表面活性剂的量基于溶液中的固体比例为5%,10%和20%。
在用聚碳酸酯聚氨酯-表面活性剂-THF-溶液包衣期间,用所定义的速度纵向来回移动量筒,同时围绕其纵轴旋转。
喷雾溶液中的聚合物浓度越高,则所得线越粗。在低浓度仅得到很细的线,其中所述结构通过喷雾溶液微滴胶结。
随层厚增加,线缠物显示对于水的更佳的润湿和铺展行为。(然而,不同浓度的表面活性剂几乎不对水或水类液体的铺展行为或线缠物表面的润湿行为带来任何影响。)
尽可能均匀地施用线缠物。取决于喷雾的内假体,层厚有所变化。在本文所描述的表面的情况下,其例如不超过20μm厚。
实施例10:用生物稳定性聚合物纤维的分子可渗透的线缠物包衣可扩展的食管支架
用大量亲水聚合物喷雾溶液:
聚醚砜/PVP-溶液:称量24.0mg PS和1.4mg PVP,用氯仿充至3g→0.80%PS,0.047% PVP
任选地,根据实施例1可以施用仅包衣支柱的聚醚砜基础层,加或不加活性剂,加或不加聚醚砜的亲水聚合物添加剂。
具有活性剂实例的喷雾溶液
a)PS/辛伐他汀/PVP-溶液:
称量23.2mg PS,8.8mg辛伐他汀和3.2mg PVP并充氯仿多至4g→0.58%PS,0.22%辛伐他汀,0.08%PCP
b.称量13.2mg PS和4.4mg紫杉醇,并充氯仿多至2g→0.66%PS,0.22%紫杉醇
c.称量11.6mg PS,3mg PVP和4.4mg紫杉醇,并充氯仿多至2g→0.58%PS,0.15%PVP,0.22%紫杉醇
在混合丝内的渗透增强性水凝胶比如PVP、PVA和其它亲水聚合物的情况下,活性剂或活性剂组合能够与聚醚砜溶于氯仿中多至约40重量百分比,得到具有至少0.04%水凝胶的能够施用至内假体的溶液。
随后,通过用线缠物的活性剂溶液(2%的挥发性溶剂中的溶液)浸渍支架包衣,向线缠物形成的孔加载雷帕霉素。
实施例11:内假体的含有丝间活性剂的线缠物包衣
将根据实施例8但未加表面活性剂的内假体用线缠物包衣。随后,通过浸渍方法并利用包衣的毛细管特性,向丝间隙充入含有活性剂的溶液。
b)类似地,通过用具有定义量活性剂的溶液喷雾表面并随后干燥,可能在线缠物包衣上涂布纯活性剂层。
c)通过将其浸入含活性剂的溶液,线缠物包衣还能够以最容易的方式与其它或相同活性剂一起加载。线缠物的孔通过毛细管力充满活性剂。
d)以相同方式,能够分开施用不同的活性剂,例如e)用将加速活性剂在血管壁中的吸收的物质来填充线缠物孔。
e)用短期生物可降解的聚合物比如PLGA 50/50填充孔,其控释或缓释活性剂。
f)前述可能变化的组合。
Claims (13)
1.内假体,其表面至少部分具有聚合物网眼细密型线缠物的包衣。
2.根据权利要求1的内假体,其中所述线缠物由至少一种选自包含下述或由下述组成的组的生物稳定或生物可降解的聚合物组成:
聚氨酯,聚对苯二甲酸乙二醇酯,聚氯乙烯,聚乙烯酯,聚乙烯缩醛聚酰胺,聚酰亚胺,聚丙烯腈,聚醚,聚酯,聚氨基酸,聚糖,聚丙交酯,聚乙醇酸交酯,聚丙交酯-co-乙交酯,脱乙酰壳聚糖,羧基烷基脱乙酰壳聚糖,胶原,聚乙二醇,聚乙烯吡咯烷酮,聚磷腈,聚苯乙烯,聚砜以及前述聚合物的衍生物、嵌段聚合物、共聚物和混合物。
3.根据权利要求1或2的内假体,其中所述线缠物包衣具有网眼。
4.根据权利要求3的内假体,其中所述网眼具有0.01μm至1000μm的平均横向直径和/或0.01μm至1000μm的平均纵向直径。
5.根据前述权利要求之一的内假体,其中所述线缠物包衣的线是多孔的。
6.根据前述权利要求之一的内假体,其中所述线缠物包衣具有定义为空气渗透率的孔隙率:在1.2kPa的压力差下1至150ml空气每平方厘米每分。
7.根据前述权利要求之一的内假体,其中所述线缠物包衣具有定义为水渗透率的孔隙率:100至300ml/(cm2*分)和尤其是150至250ml/(cm2*分)。
8.根据前述权利要求之一的内假体,还包含至少一种抗增殖剂,抗炎剂,抗迁移剂,消炎剂,抗血管生成剂,细胞生长抑制剂,细胞毒素剂,抗再狭窄剂,抗肿瘤剂,抗细菌剂和/或抗霉菌剂。
9.根据权利要求8的内假体,其中所述至少一种抗增殖剂,抗炎剂,抗迁移剂,消炎剂,抗血管生成剂,细胞生长抑制剂,细胞毒素剂,抗再狭窄剂,抗肿瘤剂,抗细菌剂和/或抗霉菌剂选自包含下述或由下述组成的组:
阿昔单抗,阿西美辛,乙酰维斯米亚酮B,阿柔比星,腺苷蛋氨酸,阿霉素,七叶素,阿佛洛莫生,东非马钱碱,阿地白介素,胺碘酮,氨鲁米特,安吖啶,阿那白滞素,阿那曲唑,银莲花素,氨基蝶呤,抗真菌药,抗血栓药,毒毛旋花甙元,阿加曲班,马兜铃内酰胺-AII,马兜铃酸,子囊霉素,天冬酰胺酶,阿司匹林,阿托伐他汀,金诺芬,硫唑嘌呤,阿奇霉素,浆果赤霉素,巴弗洛霉素,巴利昔单抗,苯达莫司汀,苯佐卡因,小檗碱,桦木醇,桦木酸,银杏酚,双银胶菊内酯,博来霉素,Bombrestatin,乳香脂酸及其衍生物,鸦胆子酚A、B和C,环落地生根素A,白消安,抗凝血酶,比伐卢定,钙粘蛋白,喜树碱,卡培他滨,邻-氨基甲酰基-苯氧基-乙酸,卡铂,卡莫司汀,塞来考昔,千金藤素,西立伐他汀,CETP抑制剂,苯丁酸氮芥,磷酸氯喹,毒芹素,环丙沙星,顺铂,克拉屈滨,克拉霉素,秋水仙碱,伴刀球霉素,香豆定,C-型利尿钠肽(CNP),拓树异黄酮A,姜黄素,环磷酰胺,环胞素A,阿糖胞苷,达卡巴嗪,达克珠单抗,放线菌素D,氨苯砜,柔红霉素,双氯芬酸,1,11-二甲氧基铁屎米-6-酮,多西他赛,多柔比星,道诺霉素,表柔比星,爱波喜龙A和B,红霉素,雌莫司汀,依托泊苷,依维莫司,非格司亭,氟尿嘧啶,氟伐他汀,氟达拉滨,氟达拉滨-5′-二氢磷酸酯,氟尿嘧啶,多叶霉素,磷雌酚,吉西他滨,Ghalakinosid,银杏酚,银杏酸,糖苷1a,4-羟基氧基环磷酰胺,伊达比星,异环磷酰胺,交沙霉素,拉帕醇,洛莫司汀,洛伐他汀,美法仑,麦迪霉素,米托蒽醌,尼莫司汀,匹伐他汀,普伐他汀,丙卡巴肼,丝裂霉素,甲氨蝶呤,巯嘌呤,硫鸟嘌呤,奥沙利铂,伊立替康,托泊替康,羟基脲,米替福新,喷司他丁,培门冬酶,依西美坦,来曲唑,福美坦,米托蒽醌,麦考酚酸莫酯,β-拉帕醌,鬼臼毒素,鬼臼酸2-乙基酰肼,莫拉司亭(rhuGM-CSF),聚乙二醇化干扰素α-2b,来格司亭(r-HuG-CSF),聚乙二醇,选择素(细胞因子拮抗剂),细胞激动素抑制剂,COX-2抑制剂,血管肽素,抑制肌肉细胞增殖的单克隆抗体,bFGF拮抗剂,普罗布考,前列腺素,1-羟基-11-甲氧基铁屎米-6-酮,东莨菪亭,NO供体,季戊四醇四硝酸酯和斯德酮胺,S-亚硝基衍生物,他莫昔芬,星孢素,β-雌二醇,α-雌二醇,雌三醇,雌酮,炔雌醇,甲羟孕酮,环戊丙酸雌二醇,苯甲雌二醇,曲尼司特,尾叶香茶菜丙素,萜类,维拉帕米,酪氨酸激酶抑制剂,酪氨酸磷酸化抑制剂,紫杉醇及其衍生物,-α-羟基-紫杉醇,紫杉特尔,莫非布宗,氯那唑酸,利多卡因,酮洛芬,甲芬那酸,吡罗昔康,美洛昔康,青霉胺,羟氯喹,金硫丁二钠,奥沙西罗,β-谷甾醇,麦替卡因,聚多卡醇,诺香草胺,左薄荷脑,玫瑰树碱,秋水仙胺,细胞松弛素A-E,Indanocine,Nocadazole,杆菌肽,玻连蛋白受体拮抗剂,氮斯汀,胍基环化酶刺激物,金属蛋白酶-1和-2的组织抑制剂,游离核酸,掺入核酸的病毒传递物,DNA和RNA片段,纤溶酶原活化剂抑制剂-1,纤溶酶原活化剂抑制剂-2,反义寡核苷酸,VEGF抑制剂,IGF-1,抗生素,头孢羟氨苄,头孢唑林,头孢克洛,头孢西丁,妥布霉素,庆大霉素,青霉素类,双氯西林,苯唑西林,磺酰胺类,甲硝唑,依诺肝素,肝素,水蛭素,PPACK,精蛋白,尿激酶原,链激酶,华法林,尿激酶,血管扩张剂,双嘧达莫,曲匹地尔,硝普盐,PDGF拮抗剂,三唑并嘧啶,Seramin,ACE抑制剂,卡托普利,西拉普利,赖诺普利,依那普利,氯沙坦,硫蛋白酶抑制剂,前列环素,伐哌前列素,干扰素α、β和γ,组胺拮抗剂,5-羟色胺阻断剂,细胞凋亡抑制剂,细胞凋亡调节剂,卤夫酮,硝苯地平,生育酚,曲尼司特,吗多明,茶多酚,表儿茶素没食子酸酯,表没食子儿茶素没食子酸酯,来氟米特,依那西普,柳氮磺吡啶,依托泊苷,双氯西林,四环素,曲安西龙,突变霉素,普鲁卡因胺,视黄酸,奎尼丁,丙吡胺,氟卡尼,普罗帕酮,索他洛尔,天然和合成获得的类固醇,桦褐孔菌醇,Maquirosid A,Ghalakinosid,Mansonin,Streblosid,氢化可的松,倍他米松,地塞米松,非甾族物质(NSAIDS),非诺洛芬,布洛芬,吲哚美辛,萘普生,保泰松,抗病毒剂,阿昔洛韦,更昔洛韦,齐多夫定,克霉唑,氟胞嘧啶,灰黄霉素,酮康唑,咪康唑,制霉菌素,特比萘芬,抗原生动物剂,氯喹,甲氟喹,奎宁,天然萜类化合物,马栗树皮苷,玉蕊皂甙元-C21-angelat,14-脱氢剪股颖酯,翦股颖克灵,剪股颖酯,17-羟基剪股颖酯,Ovatodiolide,4,7-氧基环防风酸,类燕茜素B1、B2、B3和B7,土贝母皂苷,抗痢鸦胆子甙C,鸦胆子苷N和P,异去氧地胆草素,白花地胆草内酯A和B,甘油茶碱A、B、C和D,熊果酸,山香酸A,异-德国鸢尾醛,变叶美登木醇,艾佛散宁A,香茶菜甲素A和B,长栲利素B,黄花香茶菜素C,Kamebaunin,Leukamenin A和B,13,18-脱氢-6-α-Senecioyloxychaparrin,美丽红豆杉素A和B,Regenilol,雷公藤甲素,磁麻苷,Hydroxyanopterin,原白头翁素,白屈菜红碱氯化物,中国木防己碱A和B,二氢光花椒碱,氯化光花椒碱,12-β-羟基孕二烯-3,20-二酮,堆心菊灵,大尾摇碱,大尾摇碱-N-氧化物,毛果天芥菜碱,桦褐孔菌醇,鬼臼毒素,爵床脂素A和B,Larreatin,Malloterin,Mallotochromanol,异丁酰梧桐色满醇,Maquirosid A,地钱素A,美坦生,石蒜西定,石蒜西定,水鬼蕉碱,鹅掌揪碱,双银胶菊内酯,氧化黄心树宁碱,杠柳苷A,熊果酸,脱氧普梭草素,Psycorubin,蓖麻毒素A,血根碱,马武小麦酸,甲基珍珠梅苷,Sphatheliachromen,刺叶素,Mansonin,Streblosid,Dihydrousambaraensin,羟基乌撒巴林,马钱子碱五氨合物,Strychnophyllin,乌撒巴林,乌桑巴拉碱,鹅掌揪碱,氧化黄心树宁碱,西瑞香素,落叶松树脂醇,甲氧基落叶松树脂醇,丁香树脂酚,西罗莫司及其衍生物比如Biolimus A9,依维莫司,Myolimus,Novolimus,吡美莫司,Ridaforolimus,他克莫司FK 506,坦罗莫司和唑罗莫司,生长抑素,罗红霉素,醋竹桃霉素,辛伐他汀,罗苏伐他汀,长春碱,长春新碱,长春地辛,替尼泊苷,长春瑞滨,曲磷胺,曲奥舒凡,替莫唑胺,塞替派,维A酸,螺旋霉素,伞形酮,脱乙酰维斯米亚酮A,泽渥萜,维斯米亚酮A和维斯米亚酮B。
10.根据前述权利要求之一的内假体,其中所述内假体配有外部血液相容层和/或内部血液相容层。
11.根据权利要求1-10中任一项的内假体,其中所述内假体是支架。
12.根据权利要求1-11中任一项的内假体,用于预防、减少或治疗体通道壁,狭窄,再狭窄,支架中再狭窄,晚期支架血栓形成,动脉硬化,血管阻塞,血管缩窄,缩窄的心瓣膜,动脉瘤,通至人体的人工出口和入口和在人体中铺设管腔的损伤。
13.包衣内假体的方法,包括下述步骤:
a)提供内假体,
b)将聚合物溶于挥发性溶剂中,
c)通过喷雾或电纺丝将聚合物的线缠物施用在内假体的表面上。
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CN108785316A (zh) * | 2017-04-28 | 2018-11-13 | 苏州凯祥生物科技有限公司 | 香加皮c21甾类在制备ido抑制剂中的用途 |
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CN108785316B (zh) * | 2017-04-28 | 2021-02-05 | 苏州凯祥生物科技有限公司 | 香加皮c21甾类在制备ido抑制剂中的用途 |
CN109985052A (zh) * | 2017-12-29 | 2019-07-09 | 上海蓝木化工有限公司 | 三萜类化合物的新用途 |
CN111068124A (zh) * | 2018-10-19 | 2020-04-28 | 中山大学 | 腹膜内修补用聚丙烯/茶多酚补片及其制备方法与应用 |
Also Published As
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WO2011147409A3 (de) | 2012-04-12 |
MX2012013753A (es) | 2014-02-11 |
CA2795453A1 (en) | 2011-12-01 |
IL222893A0 (en) | 2012-12-31 |
SG183555A1 (en) | 2012-10-30 |
AU2011257663A1 (en) | 2012-10-04 |
US20130103139A1 (en) | 2013-04-25 |
EP2575917A2 (de) | 2013-04-10 |
RU2012157314A (ru) | 2014-07-10 |
WO2011147409A2 (de) | 2011-12-01 |
BR112012030021A2 (pt) | 2016-08-02 |
JP2013526946A (ja) | 2013-06-27 |
KR20130086518A (ko) | 2013-08-02 |
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