CN102316823B - 多层外科用假体 - Google Patents
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- CN102316823B CN102316823B CN201080007374.6A CN201080007374A CN102316823B CN 102316823 B CN102316823 B CN 102316823B CN 201080007374 A CN201080007374 A CN 201080007374A CN 102316823 B CN102316823 B CN 102316823B
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Abstract
本发明涉及具有多层片状结构的假体,所述多层片状结构包括至少两个连续聚合物膜层。还公开制造该假体的方法,以及通过将它们植入患者而治疗患者的方法。该假体用于疝修补,腹壁、膈膜和胸壁的解剖学缺损的修补,生殖泌尿系统内缺损的矫正,和创伤性损伤器官如脾、肝或肾的修补中。
Description
发明领域
本发明总体涉及用于外科应用的假体领域,它们的生产方法和通过将它们植入患者而治疗患者的方法。更特别地,本发明涉及具有多层片状结构的假体和它们在疝修补,腹壁、膈膜和胸壁的解剖学缺损的修补,生殖泌尿系统内缺损的矫正,和创伤性损伤器官如脾、肝或肾的修补中的用途。
发明背景
腹壁修补,尤其是疝修补是美国最常见的外科手术。当腹壁内层变弱,然后凸起或撕裂,导致腹部内衬穿过变弱的区域形成气球状囊时发生疝。肠或腹部组织滑进囊中,导致疼痛或损伤的风险。小疝可用缝合修补,但较大的疝通过将网状假体外科手术地插入腹膜(将身体器官与肌肉和脂肪层分离的膜)中并用缝合线或钉将它固定在适当位置而治疗。通常将假体插入腹膜内位置以加强变弱的腹壁以防气球囊。图1示出了疝缺损和放置网状物以矫正疝缺损的实例。
类似的网状假体通常还用于其它外科程序中,包括几种壁或膈膜的解剖学缺损的修补、几种内腔或生殖泌尿系统中缺损的矫正,和创伤性损伤器官如内脏的修补。因此,可通过这种网状假体加强变弱的壁或使其完善。有时,假体缠绕在器官周围用作加强部件。所有这类假体通常由织物材料如编织或针织纤维或细丝的网状织物制成。在近十年中,已提出多种不同的用于网状织物的材料。
自二十世纪六十年代以来,聚丙烯(PP)材料已广泛用于疝修补用的网状物中。沿着该方向引入了递增的创新。然而,至今丙烯保持为不令人满意。它具有差拉伸强度和伸长,且遭受由聚丙烯材料中微裂纹形成所导致的显著老化效应,这随时间急剧地降低其强度和挠性。在植入过程中,聚丙烯还显示出一定程度的收缩。聚丙烯还导致频繁、显著且不可接受的结缔组织粘连,这总是导致炎症。组织粘连的程度与炎症的程度直接相关。如果炎症响应高,则这可导致硬瘢痕片形成。结缔组织粘连还可导致患者的严重不适以及甚至医学创伤,并可导致网状物的过早外科置换的必然性。图2显示了围绕聚丙烯网状物的这种大面积内脏粘连,因此需要另外的外科治疗的实例。
在二十世纪九十年代早期,当封闭腹部伤口时引入聚四氢呋喃(PTFE)材料将组织与内脏分离。PTFE还用作容许的技术以在腹内进行腹腔镜腹部/切口修补程序。已存在与用于疝修补中的PTFE材料相关的材料和性能问题。大多数PTFE材料被挤出并制成片。将这些PTFE片植入患者身体,即血清肿形成、感染和植入后片收缩。广泛已知PTFE片在植入后10-14天中平均收缩34%。由于这些并发症,许多这些患者不得不进行另外的外科手术以除去植入的假体。
近来,已表明PVDF为完全生物相容的,通常可具有高强度和挠性,表明其不随时间老化和改变。当使用时随时间过去它还几乎没有收缩,且具有显著更小的组织粘连问题。因此,已提议将其作为外科应用的基于织物的网状物的合适材料。
鉴于以上片状材料的经验,大多数目前的疝网状物由编织成网状物的细丝制成。尽管容易通过编织生产,但这种方法限制了网状物的设计可能。例如,基于人腹部的解剖学特征,最佳相容的网状物应在一个方向上具有与其它垂直方向相比更高的拉伸度和挠性。这不易使用细丝编织方法实现。另外,当拉伸时,这种细丝编织的网状物的开口或开孔(细丝之间的空间)的孔径大小会降低。已知该孔径大小的降低还会不利地提高内脏组织粘连的可能性。然而,尽管编织网状物的这些缺点,与疝修补相关的常用假体由不同的织物材料如网状织物制成。这种网状织物的实例公开于美国专利申请No.2007/0250147Al中。由多种合成纤维构成的针织和编织织物以及该织物在外科修补中的用途也是已知的(例如美国专利No.3,054,406)。
在目前的假体如疝修复用假体中存在两个仍未解决的关键问题。一个是不想要的内脏组织与假体粘连,即腹内器官与假体的粘连,这是对外科程序的响应,和假体导致的腹膜炎症。用现有假体如上述疝网状物,发生率非常高,导致严重的连续疼痛、固定性和肠相关问题。由于该粘连现象,大约30%以上的患者需要再次外科手术。另一关键问题是由于聚合物溶胀和/或老化,目前假体的机械特性随时间不利地改变,导致差的挠性和强度。随时间过去,假体变硬,不再符合任何方向上的腹壁移动地弯曲,导致非常差的固定和一致。通常,假体完全破裂,需要紧急外科置换。
因此,本发明的目的是提供克服一些上述困难的假体。
发明概述
根据本发明的一个方面,提供具有多层片状结构的假体。该多层片状结构包括至少两个连续的聚合物膜层。
根据本发明的另一方面,提供一种制造具有多层片状结构的假体的方法。该方法包括形成至少两个连续的膜层以产生多层结构。
在另一方面中,本发明提供一种治疗需要片状外科用假体的患者或需要疝修补,腹壁、膈膜或胸壁的解剖学缺损修补,生殖泌尿系统内缺损矫正或创伤性损伤器官如脾、肝或肾修补等的患者的方法。该方法包括将本发明假体植入需要其的患者。
其它实施方案描述于从属权利要求中。本发明的其它方面和特征还将由以下具体实施方案的描述和本发明的非限定性实施例以及附图变得明显。需要理解的是示例性实施方案和图仅设计用于阐述目的,不意欲作为本发明范围的限定。
附图简述
当连同非限定性实施例和附图一起考虑时,参考具体描述将更好地理解本发明。
图1为疝缺损和通过使用网状假体疝修补的图示,其中图1a显示由变弱腹壁导致的疝缺损,图1b显示置于并固定在腹膜内的插入网状物,图1c显示封闭腹膜以前的分解图。
图2显示粘连在内脏上的两个网状物的照片。
图3显示包括多孔层10和加强层20的本发明双层假体的横截面视图。
图4显示包括多孔层10、加强层20和防粘连涂层30的本发明三层假体的横截面视图。
图5显示图4所示假体,其两侧涂有药物释放层40和42。
图6显示假体的另一实施方案,所述假体包括位于或排列在多孔层10与加强层20之间的两个记忆效应提供层50和52。
图7为图3所示假体的实施方案的横截面视图,所述假体具有延伸穿过假体的非锥形通孔。
图8为图3所示假体的另一实施方案的横截面视图,所述假体具有延伸穿过假体的锥形通孔。
图9为图3所示假体的另一实施方案的透视图,所述假体具有延伸穿过假体的多孔层的通孔。
图10为图3所示假体的另一实施方案的透视图,所述假体具有延伸穿过假体的多孔层的通孔。
图11a-c为图3所示假体的三个不同实施方案的横截面视图,其中图11a中的假体具有粗糙表面,图11b中的假体具有锥形孔形式,图11c中的假体具有囊状孔结构。
图12a-c为具有各向异性孔形状的假体的各种实施方案的平面图。
图13a-b为具有各向异性的孔结构的本发明假体的各种实施方案的平面图。
图14为本发明假体的可选择实施方案的多孔层10的截面图,所述假体在其表面层中具有钻孔或坑洞60形式的孔。
发明详述
根据本发明第一方面的新假体具有包括至少两个连续聚合物膜层的多层片状结构。
如本发明中所用术语“假体”指可为由至少两层,即2、3、4、5或更多个成层或排列在彼此之上的片状形式的连续层构成的基本平片的任何片状结构。即使各个片具有具体厚度,但是这种基本平片通常称为二维结构。然而,片的厚度通常小,通常不被认为是第三维。因此,用于限定本文所指假体的主结构的术语片定义为具有基本在平面(二维)内延伸的形状的物体,例如补片或箔。尽管如此,片结构不限于二维结构,如果假体的至少主体(大于总体的约50%,例如55%、60%、65%、70%、75%、80%或更多)具有片状结构,则具有有复杂形状的三维亚结构的物体也落入术语假体的定义中。例如,三维亚结构可包括由相同或任何不同材料制成的在多层片上的塞。例如如果要封闭的伤口或缺损太宽而不能封闭,同时不存在任何合成材料或足够的组织封闭间隙,这种塞可用于接通两个组织之间的间隙。这种三维亚结构的另一实例可以为人造开口,例如分离例如血管或精索以防粘连在假体上的小孔或阻隔物。另一实例可以为投影导向锥(projectingguidingcone)以促进使用长的直针通过皮肤和疝囊将假体放置在腹部正中心。
可配置假体以具有任何合适的形状,只要它相对平坦(即基本在二维上延伸)且足够柔软,从而容许外科医生操纵外科用假体的形状以符合所关心的解剖点和缝合或钉在其上。假体的轮廓和尺寸可根据外科应用而改变,这对本领域技术人员是显而易见的。外科医生可在外科程序期间将假体预成型或成型。为了在植入期间足够可塑,假体在其纵轴(在这点上纵轴指主轴或主纵向伸长)可为基本柔软的。在类正方形轮廓的假体的情况下,如果正方形体在x-y平面上延伸,则纵轴例如可以为x或y轴。
本文所述假体可用于植入需要它的哺乳动物(例如人、狗、猫、兔、小老鼠、大老鼠等)。假体尤其可用于治疗任何壁缺损或损伤器官,但不限于此。壁缺损的各种实例为疝缺损,腹壁、膈膜和/或胸壁的解剖学缺损,或生殖泌尿系统中的缺损。可例如通过将片状假体缠绕在损伤器官周围或将其植入损伤器官的壁中以加强它而治疗的损伤器官的各种实例包括内脏如脾、肝、肾、肺、膀胱或心脏,或肠道的器官如胃或肠。本文所述假体的示意性实例为心脏补片,结肠补片,血管假体如血管补片,伤口愈合用补片如缝合补片或网状物,疝补片,肠胃假体如口、咽、食管、胃、小肠、大肠、直肠和肛门用假体,泌尿生殖系统用补片等。
在本发明上下文中,术语“连续聚合物膜层”特别指由为连续膜形式的聚合物材料制成的层。这种连续膜可通过已知方法制备,只要整体形成或模塑聚合物膜,即形成单片膜。换言之,本文所用连续聚合物膜层通常由液体或糊状聚合材料,其后将材料硬化产生具体形式的连续聚合物膜而制备。与本文所述连续膜层相反,由编织或针织聚合物纤维(即再成型或变形的纤维)的层制成的编织或针织织物网状物不具有如上所定义的“连续”聚合物膜结构。原因是这种织物层在具有固体/固体边界的层内相互之间包括若干显著的细丝或纤维。因此,它们不形成连续的整体形成的聚合物膜。尽管如此,聚合物膜可包括孔或通孔在如本发明所定义的术语“连续”的含义内,所述孔或通孔在聚合物膜层的生产期间例如通过浇铸、模塑等,或在其生产以后例如通过在所需区域的硬化聚合物材料的机械摩擦、切割等以形成多孔或网状结构而制备。
多层片状结构各层的层厚度可尤其考虑各层的相应机械或物理性能而调整。然而,各层的厚度通常为微米范围,例如厚度为约1-约5000μm。层应不厚于约5000μm、4500μm、4000μm、3500μm、3000μm、2500μm、2000μm、1500μm、1000μm、750μm、500μm、400μm或300μm,然而,假体应具有基本片状形状以提供对于相应治疗方法的应用或本发明假体的应用而言足够的挠性。尤其地,如果多层假体的总厚度太高,则挠性通常低以致假体不能充分固定在周围组织上,即便能与组织一起柔软且弹性地拉伸。各层的下限应为约1、2、3、4、5、10、15、20、25、50或100μm以提供足够的破裂强度给本发明假体。各层可具有上述范围内的厚度或可具有在该范围内的变化厚度。
聚合物材料可以为任何聚合物材料,包括例如生物相容和/或可生物再吸收聚合物材料的低聚物(例如2至5至10至约25重一种或多种结构单元,通常称为单体)或均聚物和/或共聚物(例如约25至50至100至250至500至约1000或更多重一种或多种结构单元,通常称为单体)。聚合物可采用例如可选自线性、环状和其中包括树枝状构造在内的支化的一种或多种构造。如果使用共聚物,则至少两个结构单元可无规、周期或嵌段状等排列。
如本文所定义,“生物相容”聚合物材料指对生物组织具有最低毒性或刺激的聚合物材料。因此,身体充分地耐受它而无不利影响。这种生物相容聚合物材料可以为长期使用的生物稳定组分,即在假体意欲保持植入在身体中的期间基本保持完整的组分。“可生物再吸收”聚合物材料定义为在假体意欲保留在身体中的期间,例如由于组分溶解、化学分解等而不能保持完整的材料。换言之,可生物再吸收材料容易对体内的生物学过程敏感。它可通过活体或其部分(例如细菌或酶作用)或环境的影响如暴露在辐射如可见光、湿气、升高的温度和/或空气下等而降解。可生物再吸收材料的降解可导致形成初级降解产物如低分子量化合物,其然后通过活体的作用进一步分解。在本发明上下文中,术语“可生物再吸收材料”特别指可通过生理代谢过程从局部区域完全除去的材料。当被细胞吸收时,可生物再吸收化合物可通过细胞机构如溶酶体或通过水解分解成组分,从而使得细胞可再使用或丢弃而对细胞没有明显的毒性作用。生物降解方法的实例包括酶或非酶水解、氧化和还原。非酶水解的合适条件例如包括在特定温度和溶酶体(即细胞内细胞器)的pH下使可生物再吸收材料暴露在水中。降解片段通常不引起或很少引起器官或细胞过载或这种过载导致的病理学过程或体内的其它不利影响。
可用于本文所述假体的多孔层中的生物相容性聚合物材料不受具体限制,可使用适于假体的任何本领域已知的生物相容性材料。生物相容性聚合物材料的实例可包括但不限于合成聚合物,包括由加聚或缩聚产生的低聚物、均聚物和共聚物。合适的加聚物的各种实例包括但不限于丙烯酸类如由丙烯酸甲酯、甲基丙烯酸甲酯、丙烯酸、甲基丙烯酸、丙烯酰胺、羟基丙烯酸酯、丙烯酸羟乙酯、甲基丙烯酸羟乙酯、丙烯酸甘油酯、甲基丙烯酸甘油酯、甲基丙烯酰胺和乙基丙烯酰胺聚合的那些;乙烯基类如苯乙烯、氯乙烯、聚乙烯醇、聚偏二氟乙烯和乙酸乙烯酯;由乙烯、丙烯和四氟乙烯形成的聚合物,或任何聚合物共混物,共聚物或其衍生物。缩聚物的各种实例包括但不限于尼龙类如聚己内酰胺或聚月桂基内酰胺;聚氨酯,聚碳酸酯,聚酰胺,聚砜和聚(对苯二甲酸乙二醇酯)。这种生物相容性聚合物材料的示意性实例包括但不限于聚偏二氟乙烯,聚酰胺,聚乙烯,聚丙烯,聚(对苯二甲酸乙二醇酯),聚氨酯,聚苯乙烯,聚甲基丙烯酸酯,聚四氟乙烯,和对二氧杂环己酮,碳酸三亚甲基酯(l,3-二氧杂环己烷-2-酮)及其烷基衍生物,戊内酯,丁内酯,癸内酯,羟基丁酸酯,羟基戊酸酯,1,5-二氧杂环庚烷-2-酮,1,4-二氧杂环庚烷-2-酮,6,6-二甲基-1,4-二氧杂环己烷-2-酮的聚合物或共聚物,或其任何聚合物共混物。
可生物再吸收聚合物材料的各种实例是本领域已知的,其中任何一种通常适用于本文所述聚合物涂层中。认为可生物再吸收的可生物再吸收聚合物材料的实例包括但不限于聚二氧杂环己酮、聚葡糖酸酯、聚乳酸-聚环氧乙烷共聚物、多糖、纤维素衍生物、基于透明质酸的聚合物、聚羟基丁酸酯、聚酐、聚磷酸酯、聚(氨基酸)、脂族聚酯、可生物降解聚醚、聚(氨基酸)、共聚(醚-酯)如PEO/PLA葡聚糖、聚草酸聚亚烷基酯、聚酰胺、聚缩酮、聚(亚氨基碳酸酯)、聚原酸酯、聚草酸酯(polyoxaester)、聚酰胺基酯、含酰胺基的聚草酸酯、聚(酐)、聚氰基丙烯酸酯、聚(氰基丙烯酸烷基酯)、聚(富马酸烷基酯)如聚(富马酸丙二醇酯)、聚磷腈、聚碳酸酯、天然存在的可生物降解聚合物如脱乙酰壳多糖、淀粉、明胶、骨胶原、纤维蛋白原、纤维蛋白、纤维素、藻酸盐、多糖、淀粉酶,或任何聚合物共混物、共聚物或其衍生物。聚原酸酯的实例包括聚乙交酯、聚丙交酯、乙交酯丙交酯共聚物(poly-co-glycolactide)、聚乳酸、聚乙醇酸、聚(乙烯乙交酯)、聚(乙二醇)、聚(乙二醇)二丙烯酸酯、聚亚烷基聚合物如聚琥珀酸乙二醇酯或聚丁烯二乙醇酸酯、聚羟基丁酸酯、聚羟基戊酸酯、聚羟基丁酸酯/聚羟基戊酸酯共聚物、聚羟基醇酸酯(alkoate)、聚酐、脂族聚碳酸酯、聚己内酯如聚(ε-己内酯)、可生物降解聚酰胺、可生物降解聚酯和/或其共聚物。可生物降解聚合物的示意性实例包括但不限于聚丙交酯如聚(L-丙交酯)(PLLA)、聚己内酯(PCL)、聚己内酯(PCL)和聚乳酸(PLA)的共聚物,或聚(丙交酯)和聚(乙交酯)(PLGA)的共聚物。可使用的共聚物的更具体实例包括但不限于乙交酯含量基于共聚物组合物为约5-50%、10-50%、15-50%或20-50%,或约20%、25%、30%、35%或50%的聚(丙交酯)和聚(乙交酯)(PLGA)的共聚物。上述可生物再吸收聚合物材料各自在身体中具有特征降解速率。例如,PGA和聚二氧杂环己酮为相对快的生物吸收材料,通常在几周至几月内降解。PLLA和聚己内酯为相对慢生物吸收材料的实例,通常在几月至几年内降解。因此,本领域技术人员能选择具有适于所需假体应用的所需降解速率的适当可生物再吸收材料。
在一些实施方案中,多孔层可作为本文所述假体的多层片状结构中的一个层提供。多孔层可由任一种上述聚合物材料如生物相容性或可生物再吸收材料制成。“多孔结构”指至少在层的外部或表面区域具有孔或在整个层中具有孔的层。“孔”指任何规则或不规则形状的孔(例如在层表面区域中的短通道或空穴(例如深度为约10-约500μm,但至少约10μm、20μm、30μm、40μm、50μm、75μm或100μm且不大于约200μm、250μm、300μm、350μm、400μm、450μm或500μm),其也称为“钻孔”或“坑洞”,或在层中的球形或非球形孔)。表面层中的这种孔或空穴产生所谓的“粗糙”表面。粗糙表面指表面构造由如本文所定义的孔组成。术语“孔”还指通孔(例如具有与上文定义相同的深度,但其延伸穿过整个多孔层)。这种通孔可以以均匀(例如具有矩形体或柱状结构)、锥形(例如具有规则或不规则圆锥或逐渐锥形的形状)或不规则(例如具有弯曲或曲折形状)方式从多孔层的上表面延伸至其内部。另外,通孔还可不仅延伸穿过多孔层,而且穿过假体的两个或更多层,例如全部所有层。这意味着孔可以为仅在多孔层内延伸或延伸穿过整个假体的通孔,由此在假体中形成微通道。通常,孔或通孔的延伸反向基本垂直于片平面的延伸。在通孔从假体的上表面延伸至假体的相反表面的情况下,假体有时称为穿孔片或网状片。
孔或通孔的界定壁由至少一对相反侧面和任选的底面限定。术语“表面”可理解为指平坦或弯曲区域,其可为任何所需几何形状。至少一部分或全部孔或通孔的两个相反侧面间的距离在微米范围内。如本文所用,术语微米范围指约1-10000μm的范围。孔的表面可以为任何所需内表面特征和任何所需材料,只要它们允许所需类型的细胞或组织生长于其中。具体表面特征的各种实施方案包括一个或多个阶梯、凹陷、倒转、凸出、沟槽或纹状体。然而,在一些实施方案中,表面可为任何一致布局,例如至少基本平坦或至少基本平面,包括具有至少基本直的表面。
此外,孔表面的不同区域可提供不同的表面特征,且含有不同材料或由不同材料组成,例如其中孔在多层结构的两个或更多个不同的聚合物膜层内延伸。这使得可在一个孔或通孔中不同地调整组织在孔中或穿过孔生长的倾向。
根据本发明,孔或通孔可具有任何所需形状,包括直的、弯曲或曲折(或缠绕)形状,可包括一个或多个弯曲、弯折或分支,只要组织可在孔中或穿过孔生长。在典型实施方案中,孔或通孔具有一个纵轴。孔可具有为任何所需外形的横截面,例如为规则如多边形、矩形(例如具有矩形、类菱形或正方形外形)或作为选择圆形结构,或具有所需不规则和/或旋绕横截面的任何其它合适不规则外形。在一些实施方案中,孔的不规则外形为不可通过编织或针织制备,但可通过使用机械摩擦或切割方法如冲压、研磨、激光切割等生产的外形。在本发明上下文中,这种不规则形状如非圆形或单对称形状也称为孔或通孔的“各向异性形状”。在本文中“各向异性”还指孔形状是不规则的,例如非圆形或单对称的,或层内的孔结构在平面图或其横截面是不规则的(即例如由具有各种孔形状或各种孔径的孔或不均匀分布的孔形成的单对称结构)。
在本发明一些实施方案中,孔充当使假体固定在腹部组织上的工具。该固定作用起因于组织增强穿透、“在其中生长”或“生长通过”多孔层或假体的孔。另外,由于较高的表面积和保留流体的能力,多孔表面也可提供高摩擦或润湿性。在一些实施方案中,可例如通过在粗糙模具上浇铸而制备的粗糙表面的摩擦可例如通过处理以改变孔或多孔层的表面而适当地改善。这种处理可包括各种方式,例如机械、热、电或化学方式。适于调整所需层的表面摩擦和/或表面粗糙度的机械处理的各种实例包括但不限于等离子处理、喷砂处理、压纹处理(例如通过印刷可成型的糊剂)或施胶(或“精压”)处理。电晕处理或放电加工可作为电处理的实例。化学处理的各种实例包括等离子聚合涂覆、溶液涂覆或化学蚀刻。作为用于提高润湿性的化学表面处理的示意性实例,例如提及通过用亲水性聚合物涂覆或通过例如用表面活性剂如三(羟甲基)丙烯酰胺基甲烷(THAM)或蔗糖酯处理而使任何疏水性表面的表面性能变得亲水的处理。化学表面处理的其它实例包括但不限于暴露于如下物质或用其涂覆:硅烷如三甲基氯硅烷、二甲基二氯硅烷、丙基三氯硅烷、四乙氧基硅烷、环氧丙氧基丙基三甲氧基硅烷、3-氨基丙基三乙氧基硅烷聚二甲基硅氧烷;聚丙烯酸酯如聚(甲基丙烯酸甲酯)或聚(甲基丙烯酸乙酯)或与其它生物相容单体的共聚物,可生物再吸收聚合物如聚(乙醇酸)、聚(乳酸)或共聚(乳酸-乙醇酸)、促进或促使内皮细胞粘连或附着在表面上的粘连促进分子,包括内皮细胞生长因子(例如血小板衍生的ECGF、ECGF-β、ECGF-2a或ECGF-2b)、肽、多肽、糖蛋白,蛋白质,例如细胞表面蛋白质如纤连蛋白、玻连蛋白、层粘连蛋白、腱糖蛋白、骨胶原、明胶、聚赖氨酸、合成肽,理想地在其氨基酸序列中具有约3-约30个氨基酸残基的粘连肽,例如精氨酸-甘氨酸-天冬氨酸盐(RGD)、精氨酸-谷氨酸-天冬氨酸-缬氨酸(REDV)和酪氨酸-异亮氨酸-甘氨酸-丝氨酸-精氨酸(YIGSR)等。
孔可具有任何孔径,只要在已将假体插入患者以后,它们的大小允许组织在愈合过程期间穿透、“生长在”孔中或“生长穿过”假体。在一些实施方案中,多孔层中的孔的平均孔径为约0.5-约5mm(包括两个极限值)。平均孔径取决于植入点和穿透、生长在其中或生长穿过腹部组织至孔中的比率。尤其地,平均孔径的下限可以为约0.6、0.7、0.8、0.9、1.0、1.1、1.2、1.3、1.4或1.5mm。平均孔径的上限可以调整至约2.5-5mm之间的任何值如约2.6、2.7、2.8、2.9、3.0、3.5、4.0、4.5mm。术语“平均孔径”指相应多孔层内所有孔的宽度或直径的平均值。就这点而言,测量平均孔径的方法是本领域已知的。示意性实例为光学显微术或扫描电子显微术,但本发明不局限于此。
在一些实施方案中,具有多层结构的假体具有支撑多孔层的额外连续聚合物膜层。在图3中,以其横截面视图显示了这种两层假体的示意性实施方案。层10为上述多孔层,其上提供有第二层20,也称为加强层。如果多层结构的其它层不具有足够的加强作用,则加强层20通常对假体提供相应的加强作用,由此使得组织加强或封闭组织或壁缺损。该层可由任何聚合物材料制成,只要所述材料具有相应的物理性能如足以确保假体在插入患者以后不破裂或撕裂并允许加强或组织封闭的破裂强度。示意性的实例包括但不限于上述生物相容或可生物再吸收的聚合物材料。在其中与多孔层相反的假体表面,即朝向内脏器官的表面用作加强层的一些实施方案中,该层也可提供对内脏组织而言的防粘连效果以避免假体与内脏组织的任何粘连。该对内脏组织的防粘连效果可例如通过支撑层表面的相对平滑即不具有基本孔或亚微米范围内的孔,或通过含有具有防粘连性能的特定聚合物材料提供。
鉴于以上内容,在假体由两层结构制成的情况下,通常将假体植入患者(通常是哺乳动物)身体,使得多孔层的外侧朝向腹壁,另一侧即上述加强层的一侧朝向内脏器官。因此,由于第一层的多孔结构,同时朝向内脏部分的第二表面防止内脏组织粘连在假体上,假体的多层结构可允许与腹部组织的良好固定。在一些实施方案中,与腹部组织的固定效果可通过向多孔层提供如上更详细解释的具有具有高摩擦或高润湿性的表面而得到改善。然而,在可选择的实施方案中,表面可涂有通过高表面摩擦和/或粗糙度或高润湿性等提供相应性能即与腹部组织的良好固定效果的其它层。
在一些实施方案中,除赋予与腹部组织的固定效果的上述第一层和上述第二加强层外,本发明假体还含有具有对内脏组织而言的防粘连效果的其它聚合物膜层。图4显示了这种三层假体的示意性实施方案的横截面视图,所述假体包括多孔层10、加强层20和防粘连涂层30。与其中层30覆盖整个层20的图4所示示意性实施方案相反,防粘连涂层30可作为假体一个或两个外表面的一部分提供,其中需要防粘连效果作为与周围器官或组织的阻隔物。
术语“防粘连涂层”指如果不需要将假体固定在这些器官或组织上,该其它层向假体提供足以防止任何器官或组织如内脏组织在假体上粘连的防粘连效果。因此,如果例如在疝修补中不需要粘连在内脏组织上,则类似于上述两层实施方案将该层提供在朝向身体中内脏组织的一侧上。防粘连涂层通常可由与其它两层相同的聚合物材料制成,只要材料性能、层的表面结构或层的其它组分如添加剂、填料、稳定剂、防粘剂等提供对内脏组织而言的防粘连效果。上文给出了要用于防粘连层中的聚合物的各种实例。
除聚合物材料外,防粘连涂层还可包含添加剂如常规添加剂或填充材料、稳定剂或防粘剂。可使用任何本领域已知的任何防粘剂,只要所述试剂为生物相容的,即例如为无毒或没有刺激。可用于防粘连涂层中的防粘剂的示意性实例包括但不限于羧甲基纤维素(CMC)、骨胶原、骨胶原/脱乙酰壳多糖混合物、ω-3脂肪酸、透明质酸、氧化再生纤维素、葡聚糖、果胶、明胶、多糖、生物相容表面活性剂如聚乙二醇、聚丙二醇或泊洛沙姆,和这些材料的衍生物和/或共混物。骨胶原和CMC可以在用作防粘剂以前交联。
在其它示意性实施方案中,上述具有两层或三层结构(或具有3、4或更多不同层的多层结构)的假体由至少1、2或3个药物释放层构成。这意味着多孔层10和/或加强层20和/或防粘连涂层30可包含一种或多种可释放药物、治疗剂和/或药学活性物质。在可选择实施方案中,上述假体在假体的一个或两个最外层上涂有另外的聚合物药物释放层,其包含一种或多种可释放药物、治疗剂和/或药药学活性物质。如果一个或多个其它层负载有药物,则也可提供两个另外的药物释放层。图5显示在两侧上涂有药物释放层40和42的图4所示假体的示意性实施方案。
在这点上,另外的药物释放层40和42可由任何上文就多层结构的其它层所定义的生物相容或可生物再吸收聚合物材料制成,只要所述材料具有药物释放性能。例如,聚合物涂层可例如通过调整药物的流出或扩散速率控制药物的流出。药物的释放也可通过聚合物涂层的控制降解而实现。如果涂覆可生物再吸收聚合物材料,则聚合物涂层应在药物流出以后在身体中生物降解以避免任何可能与聚合物化合物在体内的分解反应相关的有害效果。因此,在这些具体实施方案中,应将如上定义的可生物再吸收聚合物材料用于药物释放层40和42。另外,可将各药物释放层的表面以与多孔层10或防粘连涂层30相同的方式表面处理以具有与下层类似的功能。那意味着如果一个或两个最外面的药物释放层降解,则下层具有与相应上层类似的固定或防粘连效果。因此,假体相应表面的固定效果或防粘连效果基本不随药物释放层的降解而改变。
在本发明上下文中,术语“药物”通常指可混入任何上述药物释放层的聚合物组合物中或者浸入或掺入聚合物层中以提供含药物聚合物层的治疗剂或药剂。含药物涂层中的药物可以为任何适用于可植入假体的含药物层中的治疗剂或药剂。各种实例包括但不限于:消炎药如肾上腺皮质类固醇(氢化可的松(cortisol)、可的松(cortisone)、皮质酮(corticosterone)、布地奈德(budenoside)、雌激素(estrogen)、柳氮磺胺吡啶(sulfasalazine)、美沙拉秦(mesalamine)、氟氢可的松(fludrocortisone)、泼尼松(prednisone)、泼尼松龙(prednisolone)、6-α-甲基泼尼松龙(6-α-methylprednisolone)、曲安西龙(triamcinolone)、倍他米松(betamethasone)和地塞米松(dexamethasone),非甾族药剂(例如水杨酸衍生物如阿司匹林(aspirin));止痛药如扑热息痛(paracetamol)(醋氨酚(acetaminophen))、非甾族消炎药(NSAID)(例如水杨酸酯如阿司匹林(aspirin)、布洛芬(ibuprofen)和萘普生(naproxen))、麻醉药(例如吗啡(morphine))、具有麻醉性能的合成药(例如曲马多(tramadol));免疫抑制或免疫降低药剂(例如环孢霉素(cyclosporine)、他克莫司(tacrolimus)(FK-506)、西罗莫司(sirolimus)(雷帕霉素(rapamycin))、硫唑嘌呤(azathioprine)、麦考酚酸吗乙酯(mycophenolatemofetil))、伤口愈合或防止瘢痕形成的药剂,例如血管原药剂如血管内皮生长因子(VEGF)、成纤维细胞生长因子(FGF、PDGF、TGF-β);促进或促使内皮细胞粘连或附着在表面上的粘连促进剂,包括内皮细胞生长因子(例如血小板衍生的ECGF、ECGF-β、ECGF-2a或ECGF-2b);抗菌剂如三氯生(triclosan)或头孢菌素类(cephalosporins),或抗菌肽如马加宁(magainin)、氨基糖苷或呋喃妥因(nitrofurantoin);细胞毒试剂、细胞抑制剂或细胞增殖影响剂;血管舒张剂或妨碍内源性血管机制的药剂;防再狭窄药剂如防增生/抗有丝分裂药剂,包括天然产物如长春花生物碱(例如长春碱(vinblastine)、长春新碱(vincristine)和长春瑞滨(vinorelbine))、紫杉醇(paclitaxel)、表鬼臼毒素(epidipodophyllotoxin)(例如依托泊苷(etoposide)、替尼泊苷(teniposide))、抗生素(更生霉素(dactinomycin)(放线菌素D(actinomycinD))、柔红霉素(daunorubicin)、多柔比星(doxorubicin)和伊达比星(idarubicin))、蒽环类(anthracyclines)、米托蒽醌(mitoxantrone)、博莱霉素类(bleomycins)、普卡霉素(plicamycin)(光神霉素(mithramycin))和丝裂霉素(mitomycin)、酶(L-天冬酰胺酶(L-asparaginase),其系统代谢L-天门冬酰胺并剥夺没有所述能力的细胞合成其自身的天门冬酰胺);防增生/抗有丝分裂烷基化剂如氮芥类(如氮芥(mechlorethamine)、环磷酰胺(cyclophosphamide)和类似物、美法仑(melphalan)、苯丁酸氮芥(chlorambucil))、氮丙啶类和甲基密胺类(六甲密胺和塞替派(thiotepa))、烷基磺酸酯-白消安(busulfan)、亚硝基脲类(卡莫司汀(carmustine)(BCNU)和类似物、链脲霉素(streptozocin))、三氮烯类(trazenes)-达卡巴嗪(dacarbazinine)(DTIC);防增生/抗有丝分裂抗代谢物如叶酸类似物(甲氨喋呤(methotrexate))、嘧啶类似物(氟尿嘧啶(fluorouracil)、氟尿苷(floxuridine)和阿糖胞苷(cytarabine))、嘌呤类似物和相关抑制剂(巯嘌呤(mercaptopurine)、硫鸟嘌呤(thioguanine)、喷司他丁(pentostatin)和2-氯脱氧腺苷{克拉屈滨(cladribine)});铂配位配合物(顺铂(cisplatin)、卡铂(carboplatin))、丙卡巴肼(procarbazine)、羟基脲(hydroxyurea)、米托坦(mitotane)、氨鲁米特(aminoglutethimide);激素(例如雌激素(estrogen));抗凝血剂(肝素、合成肝素盐或凝血酶的其它抑制剂);溶纤维蛋白药(例如组织型纤溶酶原激活物、链激酶(streptokinase)和尿激酶(urokinase));抗血小板(例如阿司匹林(aspirin)、双嘧达莫(dipyridamole)、噻氯匹定(ticlopidine)、氯吡格雷(clopidogrel)、阿昔单抗(abciximab));防迁移药;抗分泌药(如布雷菲德菌素(breveldin));对氨基苯酚衍生物(例如醋氨酚(acetaminophen));吲哚和茚乙酸(例如吲哚美辛(indomethacin)、舒林酸(sulindac)和依托度酸(etodalac))、杂芳基乙酸(例如托美丁(tolmetin)、双氯芬酸(diclofenac)和酮咯酸(ketorolac))、芳基丙酸类(例如布洛芬(ibuprofen)和衍生物)、邻氨基苯甲酸(例如甲芬那酸(mefenamicacid)和甲氯芬那酸(meclofenamicacid))、烯醇酸(例如吡罗昔康(piroxicam)、替诺昔康(tenoxicam)、保泰松(phenylbutazone)和oxyphenthatrazone)、萘丁美酮(nabumetone)、金化合物(如金诺芬(auranofin)、金硫葡糖(aurothioglucose)、硫代马来酸金钠);一氧化氮供体;反义寡聚核苷酸及其组合。
在一些实施方案中,药物为选自如下的蛋白质:抗体或其抗体结合片段、生长因子如抗菌生长因子和/或心血管治疗蛋白质。可用于假体中的药物的其它实例为选自如下的小化学分子:抗炎药、止痛药、抗菌剂、伤口愈合或防止瘢痕形成的药剂和/或防再狭窄或免疫降低剂。
在本发明上下文中,需要注意的是要掺入涂层的一个或多个层中的药物(治疗或药学活性试剂)可以为小有机或化学分子、蛋白质或蛋白质片段、肽或核酸如DNA或RNA或其任意任何组合。如本文所用术语“小化学分子”通常表示含有至少两个碳原子,但优选不大于7或12个可旋转碳键,且分子量为100-2000道尔顿,或100-1000道尔顿的有机分子,其可任选含有一个或两个金属原子。如本文所用术语“肽”通常指具有2-约40、2-约30、2-约20、2-约15或2-约10个氨基酸残基的二肽或寡肽。肽可以为天然存在或合成的肽,除20个天然存在的L-氨基酸、D-氨基酸外,还可含有非天然存在的氨基酸和/或氨基酸类似物。合成肽的具体实例为精氨酸-甘氨酸-天冬氨酸盐(RGD)、精氨酸-谷氨酸-天冬氨酸-缬氨酸(REDV)和酪氨酸-异亮氨酸-甘氨酸-丝氨酸-精氨酸(YIGSR)。“蛋白质”指任何含有大于40个氨基酸残基的天然存在的多肽。蛋白质可以为全长蛋白质或截短的形式,例如活性片段。蛋白质的示意性实例包括但不限于用于所选细胞受体的抗体、其抗体结合片段或其它具有类抗体性能的结合蛋白质(例如亲合体(affibody)或称为的脂质运载蛋白突变蛋白质);血管生长抑制剂如抑制抗体、针对生长因子的抗体、由生长因子和细胞毒素组成的双官能分子、由抗体和细胞毒素组成的双官能分子;生长因子如VEGF(血管内皮生长因子)和类似的转送信号的因子、心血管治疗蛋白质或心脏激素及其活性片段或这种心脏激素的激素原或前激素原(如果它们具有小于40个氨基酸残基,则这些激素或激素原可以为如本文所定义的肽,或如果它们的多肽序列含有大于40个氨基酸残基,则为蛋白质)。心血管治疗剂的其它实例可以为肽或DNA如一氧化氮用DNA。核酸分子的实例包括正义或反义DNA分子(如果要控制目标基因的表述)或要制备的治疗活性蛋白质的编码序列(例如单独或在基因治疗媒介物中)。此时,核酸可编码促进伤口愈合的蛋白质,例如如WO97/47254所述。
在涂层的一个或多个层中的药物(或者2或更多种药物一起)的量不受限制且可以高达所需的量,只要聚合物层的物理性能,尤其是破裂强度、挠性、玻璃化转变温度或断裂伸长不会受到不利影响。在一些实施方案中,药物的量基于包含药物的聚合物层的干重可以为至多约35重量%。药物可以基于包含药物的聚合物层的干重为0.1-35重量%、1-35重量%或1-10、15、20、25或30重量%的量存在。
在一些实施方案中,假体提供有记忆效应性能。记忆效应允许多层结构自己再成型为所需外形(即具有形状记忆效应)。通过外部刺激如温度变化引发材料从变形状态(临时形状)恢复至其原始(永久)形状。该记忆效应可例如用于在外科植入期间通过使用最小侵害的(槽状小切口或天然小孔)植入技术将植入物放置在正确位置中。假体以其最小的临时形状放置在身体内的所需位置,在例如通过温度提高激活形状记忆以后,其再成型为其永久(和通常体积更大的)形状。因此,通常可使切口更小或可最小化。另外,当记忆效应假体例如用于外科缝合中时,所用材料的形状记忆性能使伤口自调节最佳张力地闭合,这避免由于太紧的缝合而导致的组织损伤并支持愈合和/或再生。
记忆效应性能可通过如上所述层10、20、30、40或42中的任一个,或通过将两个额外的提供记忆效应的层(50;52)加入多层结构中而提供。因此,不用说的是这些层可作为两个相邻层或在多层结构的不同位置提供。在图6所示示意性的实施方案(这仅为各种可能的实施方案中的一个)中,两个提供记忆效应的层50和52例如排列在多孔层10与加强层20之间,其同时具有防粘连性能。在其它实例中,例如可将两个层提供在图4或5所示三-或五层假体中。为了能保持药物释放或表面处理过的最外层的相应性能,通常代替加强层或邻近加强层提供提供记忆效应的层50和52。
提供记忆效应的层可以为任何具有足够记忆效应的材料如形状记忆聚合物(SMP)。SMP为能通过外部刺激如温度变化引发由变形状态(临时形状)恢复至其原始(永久)形状的聚合物材料。各种SMP为热塑性和热固性(交联)形状记忆聚合物如例如聚乳酸、聚乙醇酸、聚己内酯的聚合物或共聚物。那些聚合物和共聚物在医疗器械技术领域中是非常公认的。通常,SMP应为生物相容的以避免任何毒性或刺激不利影响。
具有记忆效应的两层结构的示意性实例为由聚(丙交酯)和聚(乙交酯)共聚物(PLGA)制成且聚(丙交酯)和聚(乙交酯)含量分别为约50%的层50,和由聚(丙交酯)和聚(乙交酯)共聚物(PLGA)制成且聚(丙交酯)含量为约75%和聚(乙交酯)含量为约25%的层52。
在一些实施方案中,具有多层片状结构的假体具有各向异性的孔结构或孔具有各向异性形状。这些各向异性结构使得本发明假体可适合于插入假体的位置的各向异性性质。更具体地,可通过特定的新各向异性孔结构充分且可变地控制假体的挠性和破裂强度以得到假体例如对周围肌腱膜层或周围组织的改善固定和掺入。
提供上述优点且可容易地通过本发明方法制备的示意性各向异性结构显示于图8、9和11-13中。
图8为图3所示假体(两层假体)的实施方案的横截面视图,所述假体具有延伸通过假体的所有层的锥形通孔(如虚线所示)。不用说的是,这种孔结构可应用于所有前述多层结构如具有3、4或更多不同层的假体。这种孔的横截面形状可以为任何规则或不规则形状如圆形、椭圆形、卵形、多边形(例如三角形、正方形、五边形或类菱形形状)、非圆形横截面或单对称形状。如上所述,壁表面的结构也可为不规则形状以增强表面摩擦。与具有直线形状的通孔(如虚线所示)的图7所示假体相反,组织穿透或生长进入孔中可通过特定的各向异性孔形状(锥形,例如圆锥或菱锥形状)控制。除此之外,加强层20表面上的孔径可调整在亚微米范围内使得可基本防止任何组织穿透。然而,加强层20表面上的小孔同时可例如允许药物流出。
图9为图3所示假体(具有两层结构)的另一实施方案的透视图。在该示例性实施方案中,孔作为仅通过假体多孔层的通孔形成。这还促进例如腹部组织生长进入多孔层10中,同时,加强层20充当组织的阻断或阻隔层。在该具体实施方案中,孔具有类正方形形状。
图10为图3所示假体的另一实施方案的透视图,其也具有仅延伸通过假体的多孔层(10)的通孔。在该实施方案中,孔具有圆柱形形状。
在此需要注意的是本发明假体不限于图9和10中所示的两个示意性实例。本领域技术人员已知其中可形成孔的各种形状设计。这种孔结构(在多孔层10中延伸,但也可在多层结构的1、2或更多层中延伸,或可以为延伸通过假体的通孔)的各种示意性实例例如显示于图11a、11b和11c中。各所示实施方案,例如图11a所示仅在表面区域具有空穴或凹陷的粗糙表面,例如图11b所示具有圆锥或菱锥形状的锥形孔形式,或图11c所示囊状孔形状适于提供可控的各向异性孔结构以确保假体例如与周围肌腱膜层或周围组织的更好固定和掺入。本领域技术人员可通过常规实验找到其它孔各向异性孔形状。
图12a-c和13a-b显示具有改善的各向异性孔形状或孔结构的假体的其它示意性实施方案。图12a-c为具有各向异性孔形状的假体的各种实施方案的平面图。图13a-b为具有各向异性孔结构的假体的各种实施方案的平面图。例如在图13a中,假体左侧上的孔具有正方形结构,而右侧上的孔具有类菱形形状,同时纵轴不变。类似地,在图13b所示的假体中,孔形状由左侧向右侧变化。在该实施方案中,形状由圆形向卵形变化。改变共平面孔的形状或混合不同形状的几种可能性可由本领域技术人员通过常规实验作出以设计具体的可控孔结构,其具有足以更好地复制或模拟周围组织的各向异性解剖学性质的各向异性。
需要注意的是所有这些孔形状不可通过上述现有技术所述的编织或针织技术制备,使得这些特定的新各向异性孔形状和它们对假体的各向异性的影响在外科用假体领域中是独特的。
可选择的实施方案显示于图14中。在该实施方案中,显示了在其表面层包括为钻孔或坑洞60形式的孔的多孔层10。在该图中没有显示其它层如加强层20等。多孔层的膜厚度例如为约500μm,可例如通过使用激光切割、压纹或钻孔将钻孔或坑洞60切在多孔层中。此时,由于孔60的深度小于多孔层的厚度,钻孔或坑洞60不穿透多孔层。在图14所示实施方案中,厚度例如为约300μm。在其中不提供钻孔或坑洞60的假体的其它部分中,可提供如上所述穿过多孔层或整个假体的孔如通孔(图中未显示)。因此,该实施方案的假体可具有两种不同的孔,即通孔和孔60。孔60即钻孔或坑洞可例如用于引发细胞再生。为引发细胞再生,钻孔或坑洞可含有如上所述添加剂如药物、蛋白质等,或它们可简单地充当细胞再生的空穴位置。
在本发明的第二方面中,提供了一种生产具有多层片状结构的假体的方法。该方法包括形成两个连续聚合物膜层以产生多层片状结构的步骤。
在这点上,需要提醒的是假体的任何层由为连续膜形式的聚合物材料制成。此外,连续聚合物膜层通常由液体或糊状聚合物材料,其后使材料硬化以产生连续聚合物膜而制备。在一些实施方案中,至少两个层例如通过模塑方法如注塑和压塑;涂覆方法如溶液涂覆、浸涂或旋涂;溶液浇铸;和/或挤出方法如吹挤或薄膜挤出而形成。
在使用浇铸方法的情况下,可在生产聚合物膜层期间通过使用具有孔的基质图案的特定模具用孔或通孔将聚合物膜间隔开。例如,粗糙表面可通过使用粗糙模具提供。类似地,如果使用相应的两部分或多部分模具,则任何孔结构如网状结构可容易地通过注塑技术制成。
在可选择的实施方案中,各种机械或化学处理可用于处理多层结构或1、2或更多这些层或最外层的表面。机械处理的示意性实施方案为机械摩擦或切割方法,例如冲压、研磨、激光切割、放电加工、钻孔等。通过这些方法,在所需区域处理过的相应聚合物层可容易地形成多孔或网状结构。
在另一示意性实施方案中,粗糙表面的摩擦可例如通过处理以改变孔或多孔层的表面而适当地调整,所述粗糙表面可例如通过浇铸在粗糙模具上,其后使多层结构的其它层在其上成层而制备。该处理可包括各种方法,例如机械、热、电或化学方法。适于调整所需层的表面摩擦和/或表面粗糙度的机械处理的各种实例包括但不限于等离子处理、喷砂处理、压纹处理或施胶处理。化学处理的各种实例包括等离子聚合涂覆或溶液涂覆或化学蚀刻处理。作为用于提高润湿能力的化学表面处理的示意性实例,可例如提到通过用亲水性聚合物涂覆或通过例如用表面活性剂处理而使任何疏水性表面的表面性能变得亲水的处理。
由于在其生产以后将膜激光切割,上述溶剂浇铸多层膜方法有助于克服现有细丝编织网状物方法的局限性。激光切割打开了包括各向异性设计在内的设计的所有可能性,这将最佳地匹配腹壁的各向异性解剖学性质。因此,通常使用已预先计算机分析(例如通过有限元分析,FEA;通常使用迭代法)过的设计通过激光切割由平整的多层片切割假体以得到所需的各向异性性能。相同方法也可用于使用最少量的材料实现设计。因此,材料成本可降低,可使生产过程更成本有效。另外,按照所谓的Halstead原理,引入患者的异物的量越少,他们就越好。在疝修补中,它等同于具有最少量的材料,同时具有用于永久支撑的最佳强度。使用该原理,可通过上述方法令人满意地调整孔的设计和假体的厚度。
所有这些方法允许容易地制造可控的孔结构。例如,具有不规则形状如非圆形或单对称形状的孔或具有各向异性结构的孔结构可通过这些方法生产。不用说的是规则孔结构也可通过这些方法生产。由于已就假体详细地描述了不同的孔形状,因此这里不再重复。本领域技术人员已知如何通过使用一种上述方法生产相应的形状。
在另一示例性实施方案中,多层结构的最外层通过将无机或有机细颗粒和/或无机/有机复合颗粒分散在聚合物混合物中,然后模塑相应的层以得到粗糙表面而制成。各种实例例如包括无机颗粒如二氧化硅、二氧化钛、膨润土、粘土或其混合物;有机颗粒如熔点高于聚合物膜的聚合物的低聚物或聚合物;或无机/有机复合颗粒如二氧化硅或二氧化钛作为芯材料且具有聚合物壳的颗粒。因此,可提供具有改善表面摩擦性能的粗糙表面。如果需要,可将所得粗糙表面如上所述后处理以进一步改善表面的摩擦或润湿性。
如上所述,在示意性实施方案中,所述方法包括在其中需要相应涂层的假体一个或两个外表面的至少一部分上形成防粘连涂层。所述方法还可包括提供药物释放层或记忆效应提供层的步骤。
下文描述多层假体的生产方法的示意性工作实施例,其中这些实施例不意欲将本发明局限于这三个实施方案。在所有实施例中,聚偏二氟乙烯(PVDF)用作多层假体的聚合物材料。申请人已开发了这些浇铸多层PVDF的新方法,已表明PVDF为完全生物相容的。PVDF具有更高的强度,并仍保持良好的挠性。这允许假体制得比现有聚丙烯网状物假体更薄。其还非常好地保持这些性能,且当包埋在体内时,不随时间形成裂纹,这是聚丙烯网状物中的关键问题。它高度耐水解且具有最小的收缩。这是与常规PTFE网状物相比的另一彻底改善。
(1)溶液浇铸:
根据该方法,首先将聚合物材料溶于合适的溶剂中。在包含药物的那些层中,在浇铸以前首先将药物溶于聚合物溶液中。然后将溶液应用于模具上,其中表面轮廓决定第一层的表面粗糙度或轮廓。模具的外形也是当植入膜时最终所需外形的形状。然后在类似地沉积下一层以前将层小心地干燥以释放所有溶剂。反复重复该过程直至获得所需的层数。然后将整个多层膜在模具上在一个或多个聚合物层的玻璃化转变温度以上热处理以得到所需形状的假体形成。然后在插入体内以前将具有外形的膜在25℃或以下平整为平片。一旦置于体内,膜然后在37℃下恢复其所需外形形状。
(2)浸涂:
多层膜通过垂直和以可控方式将模具在聚合物的溶液中浸涂,并将其提起而浇铸,同时在模具上涂覆聚合物层。在那些层中,在浇铸以前首先将药物溶于聚合物溶液中。然后在在另一聚合物溶液中浸涂以获得第二层以前将涂层干燥以释放所有溶剂。然后反复重复该过程直至得到所需层。模具具有决定第一层的粗糙度或轮廓的表面轮廓。模具的外形类似在植入膜以后所得的最终所需外形的形状。然后将整个多层膜在模具上在一个或多个聚合物层的玻璃化转变温度以上热处理以得到所需形状的形成。然后在插入体内以前将具有外形的膜在25℃或以下平整为平片。一旦置于体内,膜然后在37℃下恢复其所需外形形状。
(3)旋涂:
旋涂使用其中将聚合物溶液逐滴地应用于快速旋转的模具上以在模具上得到均匀旋涂涂层的方法。该方法用于所需聚合物材料。在包含药物的那些层中,在浇铸以前首先将药物溶于聚合物溶液中。模具的外形也类似在植入膜以后所得的最终所需外形的形状。然后在以相同方式将下一层沉积在在先层上以前将层小心地干燥以释放所有溶剂。反复重复该过程直至获得所需的层数。然后将整个多层膜在模具上在一个或多个聚合物层的玻璃化转变温度以上热处理以得到所需形状。然后在插入体内以前将具有外形的膜在25℃或以下平整为平片。一旦置于体内,膜然后在37℃下恢复其所需外形形状。
(4)可选择的生产方法:
类似的PVDF膜通过模塑或挤出方法而非上述浇铸方法制备。在已模塑膜以后,通过使用激光切割或机械切割(例如钻孔)切割具体孔图案,因此提供网状膜结构。
然后将由此获得的膜结构通过将包含药学活性试剂的由羧甲基纤维素(也可以相同方式使用其它可生物降解材料)制成的顶涂层粘结其上而进一步加工。为增强粘结性能,将生物相容聚合物如PLGA以另外膜的形式或作为羧甲基纤维素的附属物用作增粘剂。因此,制备包括多孔PVDF膜层的多层膜假体。
本发明另一方面涉及通过植入本发明假体而治疗患者的方法。根据本发明第三方面的方法通常包括将如先前所述本发明假体植入哺乳动物如人、狗、猫、兔、小老鼠、大老鼠等的步骤。
在一些实施方案中,该方法(或假体)可用于治疗任何壁缺损或受损器官,但不限于此。壁缺损的各种实例为疝缺损,腹壁、膈膜和/或胸壁的解剖学缺损,或生殖泌尿系统中的缺损。可例如通过将片状假体缠绕在受损器官上或将它植入受损器官壁以增强它而治疗的受损器官的各种实例包括内脏如脾、肝、肾、肺、膀胱或心脏,或肠道器官如胃或肠。所述方法的示意性实例包括植入假体,例如心脏补片、结肠补片、血管假体如血管补片、伤口愈合用补片如缝合补片或网状物、疝补片、肠胃假体如口、咽、食管、胃、小肠、大肠、直肠和肛门用假体、泌尿生殖系统用补片等。
总之,以上描述已表明可完美地使假体适应周围组织并与这些组织一致地移动。另外,假体可充分地固定在周围组织上,并由于其独特的孔结构,尤其是各向异性的孔或各向异性的孔结构能随组织挠性且弹性拉伸。因此,所述新假体可克服常规假体的大部分缺点,所述常规假体通常不能良好固定或不是挠性的(例如由几种聚合物细丝或纤维制成的常规疝网状物),因此相对于患者腹部组织痛苦地滑动。该滑动通常导致大的不适和甚至腹部创伤。
此外,由于向多层结构各层提供不同性能如朝向内脏组织的层的防粘连性能的可能性,本发明假体不允许自身显现与内脏的组织粘连。由于内脏粘连通常导致术后疼痛、肠梗阻和最严重地瘘形成,本发明新假体同时克服了常规假体的这些缺点。
此外,本发明提供了例如用于加强哺乳动物腹壁或修补壁或器官中的其它缺损的新的药物释放多层假体。为避免与内脏组织或内脏的不想要的连接,提供了其中假体的一侧包括非粘附功能,另一侧包括较高摩擦和粘附功能以促进假体与组织或器官表面固定的假体。该假体也可用于其它外科程序中,包括腹壁、膈膜和胸壁的解剖学缺损的修补,生殖泌尿系统缺损的矫正和创伤性损伤器官如脾、肝或肾的修补。
Claims (79)
1.一种具有包括至少两个连续聚合物膜层的多层片状结构的假体,其中所述连续聚合物膜层为聚偏二氟乙烯或其共聚物的整体形成的层。
2.根据权利要求1的假体,其中多层结构中的至少一层为具有孔的多孔层。
3.根据权利要求2的假体,其中所述孔从多孔层的一个表面延伸至多孔层的另一表面以在多孔层中形成通孔。
4.根据权利要求2的假体,其中所述孔从假体的一个表面延伸至假体的另一表面以在假体的多层结构中形成通孔。
5.根据权利要求2的假体,其中多孔层具有高摩擦以能良好地固定在腹部组织上。
6.根据权利要求3的假体,其中多孔层具有高摩擦以能良好地固定在腹部组织上。
7.根据权利要求4的假体,其中多孔层具有高摩擦以能良好地固定在腹部组织上。
8.根据权利要求2-7中任一项的假体,其中多孔层具有高润湿能力以能固定在腹部组织上。
9.根据权利要求2、3或5-7中任一项的假体,其中与多孔层表面相反的多层片状结构的表面具有对内脏组织的防粘连作用。
10.根据权利要求1-7中任一项的假体,所述假体另外包括在假体的一个或两个外表面的至少一部分上的防粘连涂层。
11.根据权利要求10的假体,其中防粘连涂层包含生物相容或可生物再吸收聚合物。
12.根据权利要求10的假体,其中防粘连涂层包含防粘剂。
13.根据权利要求12的假体,其中防粘剂为羧甲基纤维素,骨胶原,ω-3脂肪酸,透明质酸,氧化再生纤维素,明胶,多糖,生物相容性表面活性剂,和来自这些材料的衍生物和/或共混物。
14.根据权利要求13的假体,其中所述生物相容性表面活性剂为聚乙二醇、聚丙二醇或泊洛沙姆。
15.根据权利要求1的假体,其中多层结构的各层包含生物相容或可生物再吸收聚合物材料。
16.根据权利要求11或权利要求15的假体,其中生物相容性聚合物材料为如下材料中的任一种:聚偏二氟乙烯,聚酰胺,聚乙烯,聚丙烯,聚(对苯二甲酸乙二醇酯),聚氨酯,聚苯乙烯,聚甲基丙烯酸酯,聚四氟乙烯,和对二氧杂环己酮、碳酸三亚甲基酯(l,3-二氧杂环己烷-2-酮)及其烷基衍生物、戊内酯、丁内酯、癸内酯、羟基丁酸酯、羟基戊酸酯、1,5-二氧杂环庚烷-2-酮、1,4-二氧杂环庚烷-2-酮、6,6-二甲基-1,4-二氧杂环己烷-2-酮的聚合物或共聚物,或其任意聚合物共混物。
17.根据权利要求11或权利要求15的假体,其中可生物再吸收聚合物材料为如下材料中的任一种:聚乙交酯、聚丙交酯和乙交酯丙交酯共聚物、聚乳酸、聚乙醇酸、聚(乙烯乙交酯)、聚乙二醇、聚己内酯、聚二氧杂环己酮、聚葡糖酸酯、聚乳酸-聚环氧乙烷共聚物、多糖、纤维素衍生物、基于透明质酸的聚合物、淀粉、明胶、骨胶原、聚羟基丁酸酯、聚酐、聚磷酸酯、聚(氨基酸)或其任意聚合物共混物、共聚物或衍生物。
18.根据权利要求17的假体,其中所述聚己内酯为聚(ε-己内酯)。
19.根据权利要求2-7中任一项的假体,其中所述孔的平均孔径为0.5-5mm。
20.根据权利要求2-7中任一项的假体,其中所述孔的平均孔径为1-4mm。
21.根据权利要求2-7中任一项的假体,其中所述孔具有规则或不规则形状。
22.根据权利要求21的假体,其中具有规则形状的孔具有圆形、椭圆形、卵形或多边形形状。
23.根据权利要求21的假体,其中具有规则形状的孔具有三角形、正方形、五边形或类菱形形状。
24.根据权利要求21的假体,其中具有不规则形状的孔具有非圆形横截面或单对称形状以提供各向异性的孔结构。
25.根据权利要求21的假体,其中多层结构中的共平面孔具有不同的孔直径或孔形状以提供各向异性的孔结构。
26.根据权利要求2-7中任一项的假体,其中所述孔在其横截面中具有各向异性的形状。
27.根据权利要求26的假体,其中所述孔的各向异性形状由多孔层的上表面至其内部或假体的相反侧面逐渐变小。
28.根据权利要求24的假体,其中各向异性的孔结构或所述孔的各向异性形状适合于要将假体插入患者的位置的各向异性解剖学性质。
29.根据权利要求1-7中任一项的假体,其中多层结构的一个、两个或更多个层为包含一种或多种可释放药物、治疗剂和/或药学活性物质的药物释放层。
30.根据权利要求29的假体,其中多层结构的多孔层或防粘连涂层为包含一种或多种可释放药物、治疗剂和/或药学活性物质的药物释放层。
31.根据权利要求1-7中任一项的假体,所述假体在假体的一个或两个最外层上进一步包括另外的聚合物药物释放层,其包含一种或多种可释放药物、治疗剂和/或药学活性物质。
32.根据权利要求29的假体,其中药物选自小化学分子、肽、蛋白质、核酸或其任意组合。
33.根据权利要求32的假体,其中蛋白质选自抗体或其抗体结合片段、生长因子和/或心血管治疗蛋白质。
34.根据权利要求33的假体,其中所述生长因子为抗菌生长因子。
35.根据权利要求32的假体,其中小化学分子选自消炎药、止痛药、抗菌剂、伤口愈合或防止瘢痕形成的药剂和/或防再狭窄或免疫降低剂。
36.根据权利要求1-7中任一项的假体,其中假体具有记忆效应性能。
37.根据权利要求36的假体,所述假体包括在其多层片状结构中提供记忆效应性能的两个额外层。
38.根据权利要求1-7中任一项的假体,其中多层片状结构沿着片状结构的纵轴基本为挠性的。
39.根据权利要求1-7中任一项的假体,其中多层片状结构包括至少两种不同的孔结构,其中第一孔结构包括穿过多孔层或穿过假体的通孔,第二孔结构包括在其中没有提供第一孔结构的那些多孔层部分上的一个或多个钻孔或坑洞,其中钻孔或坑洞的深度小于多孔层的厚度。
40.一种制造具有多层片状结构的假体的方法,所述方法包括形成聚偏二氟乙烯或其共聚物的至少两个连续聚合物膜层且所述连续聚合物膜层是整体形成的。
41.根据权利要求40的方法,其中所述至少两个层通过模塑方法;涂覆方法;溶液浇铸;和/或挤出方法形成。
42.根据权利要求41的方法,其中所述模塑方法为注塑或压塑。
43.根据权利要求41的方法,其中所述涂覆方法为浸涂或旋涂。
44.根据权利要求41的方法,其中所述挤出方法为吹挤或薄膜挤出。
45.根据权利要求40的方法,其中多层片状结构的最外层通过将聚合物浇铸在粗糙的模具上以得到粗糙表面,在其上形成其它层,然后机械或化学处理多孔层的所述粗糙表面以提高其表面摩擦和润湿能力而形成。
46.根据权利要求45的方法,其中粗糙表面的机械处理包括等离子处理、喷砂处理、压纹处理或施胶处理。
47.根据权利要求45的方法,其中粗糙表面的化学处理包括蚀刻处理或涂覆。
48.根据权利要求47的方法,其中所述涂覆为等离子聚合涂覆或溶液涂覆。
49.根据权利要求40的方法,其中多层结构的最外层通过将无机或有机细颗粒和/或无机/有机复合颗粒分散在聚合物混合物中,然后模塑相应层得到粗糙表面而制成。
50.根据权利要求49的方法,其中无机颗粒包括二氧化硅、二氧化钛、膨润土、粘土或其混合物。
51.根据权利要求49的方法,其中有机颗粒包括熔点高于聚合物膜的聚合物的低聚物或聚合物。
52.根据权利要求49的方法,其中无机/有机复合颗粒包括在芯中的二氧化硅或二氧化钛颗粒和聚合物壳。
53.根据权利要求40或权利要求41的方法,其中通过使用具有孔图案的基质在多层结构的一个或多个层中制造孔。
54.根据权利要求40或权利要求41的方法,其中以固体层的形式作为最外层形成多孔层,然后通过机械处理由该固体层形成多孔结构。
55.权利要求54的方法,其中机械处理为研磨方法、激光切割方法、放电加工、冲压或机械摩擦方法。
56.根据权利要求40-52中任一项的方法,其中在假体的一个或两个外表面的至少一部分上形成防粘连涂层。
57.根据权利要求56的方法,其中防粘连涂层包含生物相容或可生物再吸收聚合物。
58.根据权利要求56的方法,其中防粘连涂层包含防粘剂。
59.根据权利要求40方法,其中多层结构由至少两个包含生物相容或可生物再吸收聚合物材料的层制成。
60.根据权利要求57或权利要求59的方法,其中生物相容性聚合物材料为如下材料中的任一种:聚偏二氟乙烯,聚酰胺,聚乙烯,聚丙烯,聚(对苯二甲酸乙二醇酯),聚氨酯,聚苯乙烯,聚甲基丙烯酸酯,聚四氟乙烯,和对二氧杂环己酮、碳酸三亚甲基酯及其烷基衍生物、戊内酯、丁内酯、癸内酯、羟基丁酸酯、羟基戊酸酯、1,5-二氧杂环庚烷-2-酮、1,4-二氧杂环庚烷-2-酮、6,6-二甲基-1,4-二氧杂环己烷-2-酮的聚合物或共聚物,或其任意聚合物共混物。
61.根据权利要求57或权利要求59的方法,其中可生物再吸收聚合物材料为如下材料中的任一种:聚乙交酯、聚丙交酯和乙交酯丙交酯共聚物、聚乳酸、聚乙醇酸、聚(乙烯乙交酯)、聚乙二醇、聚己内酯、聚二氧杂环己酮、聚葡糖酸酯、聚乳酸-聚环氧乙烷共聚物、多糖、纤维素衍生物、基于透明质酸的聚合物、淀粉、明胶、骨胶原、聚羟基丁酸酯、聚酐、聚磷酸酯、聚(氨基酸)或任意聚合物共混物、共聚物或衍生物。
62.根据权利要求61的方法,其中所述聚己内酯为聚(ε-己内酯)。
63.根据权利要求40-52中任一项的方法,其中至少一个层提供有平均孔径为0.5-5mm的孔。
64.根据权利要求40-52中任一项的方法,其中至少一个层提供有平均孔径为1-4mm的孔。
65.根据权利要求40-52中任一项的方法,其中至少一个层提供有具有规则或不规则形状的孔。
66.根据权利要求65的方法,其中具有规则形状的孔具有圆形、椭圆形、卵形或多边形形状。
67.根据权利要求65的方法,其中具有规则形状的孔具有三角形、正方形、五边形或类菱形形状。
68.根据权利要求65的方法,其中具有不规则形状的孔具有非圆形横截面或单对称形状以提供各向异性的孔结构。
69.根据权利要求65的方法,其中多层结构中的共平面孔具有不同的孔直径或孔形状以提供各向异性的孔结构。
70.根据权利要求40的方法,其中至少一个层提供有在其横截面中具有各向异性形状的孔。
71.根据权利要求70的方法,其中所述孔的各向异性形状由多孔层的上表面至其内部或假体的相反侧面逐渐变小。
72.根据权利要求68的方法,其中各向异性的孔结构适合于要将假体插入患者的位置的各向异性解剖学性质。
73.根据权利要求69的方法,其中各向异性的孔结构适合于要将假体插入患者的位置的各向异性解剖学性质。
74.根据权利要求70的方法,其中所述孔的各向异性形状适合于要将假体插入患者的位置的各向异性解剖学性质。
75.根据权利要求40-52中任一项的方法,其中多层结构的一个、两个或更多个层通过在模塑所述层以前在相应层中加入一种或多种可释放药物、治疗剂和/或药学活性物质或通过将它们浸入模塑层中而制成药物释放层。
76.根据权利要求75的方法,其中多层结构的多孔层或防粘连涂层通过在模塑所述层以前在相应层中加入一种或多种可释放药物、治疗剂和/或药学活性物质或通过将它们浸入模塑层中而制成药物释放层。
77.根据权利要求40-52中任一项的方法,所述方法进一步包括在假体的一个或两个最外层上形成另外的聚合物药物释放层的步骤,其中聚合物药物释放层包含一种或多种可释放药物、治疗剂和/或药学活性物质。
78.根据权利要求40-52中任一项的方法,其中在多层片状结构中形成两个层以提供记忆效应。
79.根据权利要求78的方法,其中这两个层作为在假体的多层片状结构中提供记忆效应性能的两个另外的层而由聚合材料形成。
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CN102316823A (zh) | 2012-01-11 |
WO2010093333A1 (en) | 2010-08-19 |
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JP2012517319A (ja) | 2012-08-02 |
EP2395941B1 (en) | 2017-01-11 |
US9486302B2 (en) | 2016-11-08 |
US20120010636A1 (en) | 2012-01-12 |
JP2015147098A (ja) | 2015-08-20 |
JP5973168B2 (ja) | 2016-08-23 |
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