CN109715403B - 层压可吸收半结晶聚合物膜的方法 - Google Patents
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Abstract
本发明涉及用于层压半结晶、高熔点、低玻璃化转变聚合物膜的新型工艺,所述聚合物膜被挤出并随后被层压在各种热敏基底上,以在特定时间间隔中形成层压医疗装置构造,从而允许使用低加工温度以避免聚合物膜和/或基底降解或热相关的变形。本发明还公开了由此类工艺制得的层压医疗装置构造。
Description
技术领域
本发明涉及的技术领域是用于将可吸收、半结晶、高熔点聚合物膜层压在用于可吸收和部分可吸收医学应用的各种热敏基底上的新型方法。
背景技术
合成可吸收聚酯是本领域中所熟知的。术语可吸收的、可生物吸收的、可生物再吸收的、可再吸收的、可生物降解的在本文中可互换使用。公开的专利文献尤其描述了由乙交酯、L(-)-丙交酯、D(+)-丙交酯、内消旋-丙交酯、ε-己内酯、对二氧杂环己酮和三亚甲基碳酸酯制得的聚合物和共聚物。
聚合物膜形式的医疗装置或包含基底和层压膜的复合结构在本领域中是已知的,并且可用于各种外科应用,包括组织修复、疝修复、器官修复等。
多年来,许多研究人员还描述了可吸收膜和由可生物吸收聚合物材料形成此类膜的工艺,例如美国专利7,943,683 B2“Medical Devices Containing Oriented FilmsofPoly-4-hydroxybutyrate and Copolymers”;美国专利8,030,434B2“Polyester Film,Process for Producing the Same and Use Thereof”;美国专利4,942,087A“Films ofWholly Aromatic Polyester and Processes for Preparation Thereof”;美国专利4,664,859A“Process for Solvent Casting a Film”;以及美国专利5,510,176A“Polytetrafluoroethylene Porous Film”。已知并存在用于生产聚合物膜的各种常规方法和工艺。这些方法和工艺包括但不限于熔体挤出、溶剂浇铸和压缩模塑。然而,并非所有聚合物都可易于转化成膜产品;另外,不同的转化技术具有不同的挑战。在熔体挤出的情况下,树脂必须是热稳定的,表现出适当的熔体粘度,即不会太低以致引起“滴落”,也不会太高以致在挤出机中产生过高的压力,带来不稳定性及不均匀的结果。在树脂具有低玻璃化转变温度的情况下,如果聚合物形态包括一些链取向,则由其制得的膜的尺寸稳定性可能非常低。这是收缩和扭曲的很大一种驱动力。为了避免尺寸不稳定性困难,在膜中形成一定量的结晶度是有利的。结晶速率对于建立稳定的膜挤出过程是重要的,而总体结晶度对于获得尺寸稳定性和良好的机械性能是重要的。已知结晶度水平太低将导致膜在环氧乙烷灭菌时,或在加工、运输或储存期间暴露于轻微升高的温度时可能发生变形。在某些外科应用中,希望最终的膜牢固以具有适当的抗撕裂性,但又足够柔韧以具有良好的处理特性。此类外科应用的示例包括含疝膜的修复贴片需要缝合和/或粘合作为固定到周围组织的手段;在膜是承重部件的情况下,各种膜基医疗装置在植入前要经过广泛的处理和操作等。
如果用于制造膜的可吸收聚合物适用于通过熔体挤出工艺来制造外科膜产品,则该聚合物必须具有一定的熔体和热性能、一定的结晶特性以及一定的机械和水解性能。在通过溶液浇铸制得膜的情况下,聚合物树脂需要在合适的溶剂中具有适当的溶解度。合适的溶剂有利地具有适当的蒸气压曲线,从而带来合适的蒸发速率,并且通常是无毒的。如果聚合物适用于通过溶剂浇铸加工来制造外科膜产品,则该聚合物必须具有一定的溶解度和结晶特性,以及一定的机械和水解性能。
已经在专利文献中描述了在不同基底上层压聚合物膜的方法。例如,美国专利8,349,354B2(Andjelic)描述了一种止血复合结构,其具有可吸收织物或非织造基底和层压在基底的一个主表面上的连续无孔聚合物膜。然而,该膜层限于无定形聚合物材料,或熔点温度低于120℃的半结晶聚合物材料。
对于熔点温度显著高于120℃(例如,为约200℃)的聚合物膜的层压,在现有技术中已经使用和公开了不同的方法,所述方法包括如US 7,615,065和US 8,821,585B2中所述在高熔点聚合物膜和基底之间添加粘合剂层。在市场上,ETHICON PHYSIOMESHTM网装置是市售的疝网产品,其由可吸收聚合物膜(基于75/25Gly/Cap树脂)与不可吸收聚丙烯网联合制得。为了将高熔点聚合物膜接合到网上,在网的两侧使用低熔点聚(对-二氧环己酮)-基膜(熔点为110℃)的间层来将这三种结构胶合在一起形成复合结构。如果没有使用粘合剂层/膜用于粘结,则需要150℃以上的高温将可吸收聚合物膜粘结到网上,从而导致网变形和收缩。另一方面,用于粘结目的的附加层的存在增加了不良组织反应(释放更多降解产物,诸如游离酸)的风险,降低了生物相容性,并且增加了装置刚度;它还显著增加了生产成本并使此类医疗装置的制造复杂化。
与上述技术类似,US 3,467,565A描述了使用低熔点塑料膜诸如聚乙烯将高熔点塑料膜诸如尼龙层压到载体幅材上。该公开没有提及关于在可吸收聚合物体系上使用该技术。
US 4,475,971A中描述的形成强交叉层压平膜的方法包括具有较高熔点层和较低熔点层的复合共挤出膜结构。较高熔点层可以是聚乙烯、尼龙、聚酯或聚丙烯,而较低熔点组分选自乙烯/乙酸乙烯酯共聚物、低密度聚乙烯聚合物和乙烯/丙烯共聚物。同样,低熔点组分作为胶合剂用于所有不可吸收组分上。
US 6,911,244B2描述了用于柔性膜的包封阻挡物,其包括由热敏材料优选乙烯-乙烯醇和至少一种基底优选由两个或更多个粘合剂层包封的定向聚丙烯制得的阻挡层。除了具有粘结功能之外,粘合剂层还可保护阻挡材料免受硬件的高温和硬件内的长停留时间的影响。
US 20130001782A1提出了一种利用低熔点薄金属膜在三层结构上层压高熔点焊接层以制造半导体器件的方法。
US 5,629,077描述了一种用于血管的可生物降解网和膜支架,其包括由可生物降解高强度聚合物纤维与第二可生物降解粘合剂聚合物粘结在一起制得,并且在至少一侧上层压有第三可生物降解聚合物的薄膜的复合网材料片。通过经由较低温度的粘合剂可生物降解层诸如ε-己内酯,或低熔点温度的多种纤维在网状结构中热粘结来实现层压。
US 3,932,693A中描述了具有多层膜结构并且具有低蒸汽和气体渗透性的层压食品包装。该结构包括使用乙酸乙烯酯含量大于10重量%的乙烯/乙酸乙烯酯共聚物膜层层压到偏二氯乙烯聚合物层上的定向聚丙烯膜的基层。
US 4,119,481A描述了一种由无定形二氧化硅纤维制得的熔融层压高温织物,其具有使用高能红外辐射由乙烯基聚酯或氨基甲酸酯聚合物制得的热塑性膜。高能量优选在短时间和空间内被吸收,从而导致温度升高到足以产生与热塑性膜粘合所需的程度。虽然该层压方法不需要附加的粘合剂元件,但是在织物和/或膜由可吸收聚合物制得的情况下,使用高能辐射会引起降解。
US 2,269,125A中描述了一种制得层压尼龙基织物的方法。该方法提供了用水处理织物以便更易于热压力粘结。吸收的水分显著降低了玻璃化转变温度并提高了尼龙基纤维的导热性,从而允许使用较低的层压温度。然而,在可吸收聚合物结构上使用带有热量的水分会导致聚合物显著降解。
总而言之,本领域一直迫切需要将高熔融温度的半结晶可吸收膜有效地层压在各种热敏可吸收或不可吸收基底上而不需要任何附加粘合剂层或任何类型的胶合物质(包括水分)的新型方法。热敏基底的层压需要使用低层压温度诸如120℃或更低温度进行,以避免化学降解和物理变形,并且需要新型方法来提供此类基底的层压。
发明内容
因此,本发明公开了新型层压方法和层压医疗装置构造。
本发明的一方面为一种制造压层医疗装置构造的方法。将半结晶聚合物膜挤出,该聚合物膜具有140℃或更高的熔点温度、低于25℃的玻璃化转变温度和结晶度,其中所述聚合物膜在室温/环境条件下可结晶。
通过在挤出聚合物膜后的约10分钟内进行热/压力层压步骤,将聚合物膜层压到热敏聚合物基底,以形成层压医疗装置构造,其中所述膜具有约10%或更低的结晶度,并且在约120℃或更低的温度下将所述膜层压到基底上,使得基底不会损坏或降解并且将膜有效地层压到基底。
本发明的另一方面为一种制造层压医疗装置构造的方法。将半结晶聚合物膜挤出,该聚合物膜具有140℃或更高的熔点温度、低于25℃的玻璃化转变温度和结晶度。
通过在挤出聚合物膜后的约10分钟内进行热/压力层压步骤,将聚合物膜层压到热敏聚合物基底,以形成层压医疗装置构造,其中所述膜具有约10%或更低的结晶度,并且在约120℃或更低的温度下将所述膜层压到基底上,使得基底不会损坏或降解并且将膜有效地层压到基底,并且其中层压聚合物膜具有至少约10%的可实现结晶度。
本发明的又一方面为一种将聚合物膜层压到热敏聚合物基底的方法。首先,将具有熔融温度的可吸收聚合物转移到装有缝模的熔体挤出机的料斗中,其中机筒和模具温度在高于所述可吸收聚合物熔融温度约10℃的范围内。将可吸收聚合物通过所述缝模挤出,从而形成膜。将膜拉伸约0.8倍至约10倍,使得膜的厚度在0.01密耳和10密耳之间。在膜挤出后0和10分钟之间的时间间隔中,在结晶度为约10%或更低的新挤出的聚合物膜与热敏聚合物基底之间提供接触。然后,在120℃或更低的温度下对膜和基底进行热压以形成压层构造。
本发明的又一方面是一种使用任何上述方法制得的层压医疗装置构造。
具体实施方式
如本文所用,术语“热敏聚合物基底”被定义为意指网状或者非织造或织造多孔结构形式的聚合物基底,其在经受相对高的加工温度诸如140℃或更高的温度时经历化学降解或各种物理变形(例如,收缩)。虽然优选的是聚合物膜由可吸收聚合物制得,但在一个另选实施方案中,聚合物膜可由不可吸收聚合物制得。
本文所用的术语“层压膜的可实现结晶度”被定义为意指通过应用各种热和加工手段诸如退火聚合物膜可以实现的最大结晶度水平。
本发明涉及适用于半结晶聚合物膜的新型层压方法,该半结晶聚合物膜具有140℃或更高的高熔点,并且具有25℃或更低的玻璃化转变温度。在一个优选的实施方案中,聚合物膜是可吸收的。可将此类膜层压到非织造或织造的可吸收或不可吸收聚合物基底上,特别是热敏基底上,其中层压在120℃或更低的温和加工温度下进行。本发明的另一方面是一种适用于可吸收的半结晶聚合物膜的新型层压方法,该聚合物膜的熔点为140℃或更高,玻璃化转变温度高于25℃,并且在层压聚合物膜中的可实现结晶度为10%或更高。在一个优选的实施方案中,聚合物膜是可吸收的。可将此类膜层压到非织造或织造的可吸收或不可吸收聚合物基底上,特别是热敏基底上,其中层压在120℃或更低的温和加工温度下进行。
由本发明实践中可用的共聚物制得的膜可用于各种医学应用,包括组织分离屏障、增强支撑材料、止血、药物递送和粘合预防。可将该膜与其它装置(诸如,网和其它纺织物)层压在一起以形成多层结构。
在一个实施方案中,膜层由聚合物材料制得,该聚合物材料是熔点高于140℃的半结晶可吸收聚合物。在另一个实施方案中,膜层由熔点温度高于150℃、更优选高于180℃的聚合物材料制得。在另一个实施方案中,膜层由玻璃化转变温度低于约25℃的聚合物材料制得。在本发明工艺的另一个实施方案中,膜层由聚合物材料制得,该聚合物材料是熔点高于140℃、玻璃化转变温度高于约25℃并且在层压膜中的可实现结晶度为10%或更高的半结晶可吸收聚合物。
本发明还涉及一种止血复合结构,其具有可生物吸收织物或非织造基底和聚合物基膜,该基底具有至少两个背对的主表面区域,该聚合物基膜层压在所述基底的至少一个主表面上。通过将复合结构施加到伤口部位来实现止血,其中将基底的没有膜层的主表面施加到伤口部位上。可生物吸收织物基底可以是氧化多糖并且/或者非织造基底可由可生物吸收的非纤维素衍生聚合物制得。聚合物基膜可以是常规的可生物吸收聚合物,诸如选自聚(乙氧基乙烯二甘醇酸酯-共-乙交酯)、聚(丙交酯)、聚(乙交酯)、聚(氨基酸)以及它们的共聚物和三元共聚物的可生物吸收聚合物。还包括具有较低熔融组分的丙交酯和/或乙交酯的均聚物和共聚物,该低熔点组分包括己内酯、对二氧杂环己酮、三亚甲基碳酸酯(TMC)、聚乙二醇和各种聚醚酯制剂。在一个实施方案中,基底由氧化的再生纤维素制得,并且顶涂膜为共聚物,优选75/25聚(乙交酯-共-ε-己内酯)。在特别优选的实施方案中,膜具有约0.1至10密耳范围内的厚度。在另一个实施方案中,聚合物膜由不可吸收的常规聚合物诸如聚丙烯、聚乙烯、聚对苯二甲酸乙二醇酯、尼龙等制得。
本发明的层压复合结构还可任选地包括生物活性剂,诸如止血剂,包括诸如促凝血酶、蛋白质和肽、凝血酶原、凝血酶、纤维蛋白原、纤维蛋白、纤粘蛋白、肝素酶、因子X/Xa、因子VII/VIIa、因子IX/IXa、因子XI/XIa、因子XII/XIIa、组织因子、巴曲酶、安克洛酶、蛇静脉酶、von Willebrand因子、胶原、弹性蛋白、白蛋白、明胶、血小板表面糖蛋白、加压素和加压素类似物的止血剂、肾上腺素、选择蛋白、促凝血毒液、纤维蛋白溶酶原激活剂抑制剂、血小板激活剂、具有止血活性的合成肽、上述物质的衍生物以及它们的任何组合的止血剂。在一个实施方案中,止血剂选自凝血酶、纤维蛋白原和纤维蛋白。
包括聚合物膜和基底的复合结构通常具有较好的用于外科应用和设置的处理性能。多种织物或非织造基止血材料不具有理想的处理特性,因为它们在外科手术(尤其是在存在血液或其它流体的情况下)期间起皱和折叠。本发明的基底/膜复合物使此类行为降至最低。另外,膜的存在改善织物或非织造基底基材料的机械强度和柔性,从而增强其在腹腔镜手术中的适用性。在腹腔镜手术中,期望所述复合物比单独的基底或膜组件更易于推过套管针和弹开到体腔内。
相对于现有的止血装置,本发明的复合结构通常在外科手术期间具有更好的保持在适当位置的倾向和/或能力。例如,以多层使用的一些织物基产品或非织造形式的那些产品在施用过程中可破裂或其部件可迁移。本发明的基底/膜复合结构有助于保持止血材料的物理完整性,因此其在手术期间不可能过早地破碎、弯曲、或迁移。该复合结构的另一个优点是可将装置缝合在适当位置。
由本发明的方法制得的复合结构装置还提供了将膜组件用于其它外科功能的可能性,诸如提供组织支承、帮助伤口愈合和/或充当生物活性剂的递送载体。
可用于制备本发明的层压复合结构中的织物或非织造基底的聚合物包括但不限于胶原、藻酸钙、甲壳质、聚酯、聚丙烯、多糖、聚丙烯酸、聚甲基丙烯酸、多胺、聚亚胺、聚酰胺、聚酯、聚醚、多核苷酸、聚核酸、多肽、蛋白质、聚(环氧烷)、聚亚烷基类(polyalkylenes)、聚硫酯、聚硫醚、聚乙烯基类、包含脂质的聚合物以及它们的混合物。优选的纤维包含氧化再生多糖,尤其是氧化再生纤维素。
优选地,使用氧化多糖来制备本发明的伤口敷料。更优选地,使用氧化纤维素来制备用于本发明的伤口敷料中的织物。纤维素可为羧基氧化纤维素,或者可为醛氧化纤维素,上述各种物质如本文所定义和所述。甚至更优选地,使用氧化再生纤维素来制备用于本发明的伤口敷料中的织物基底。再生纤维素因其相对仍未再生的纤维素具有较高的均匀度而为优选的。再生纤维素和如何制得再生氧化纤维素的详细说明在美国专利3,364,200和美国专利5,180,398中有所描述,这些专利中的每一个的内容据此以引用方式全文并入本文。由此,有关再生氧化纤维素及其制得方法的教导内容完全在止血伤口敷料领域的技术人员的知识范围内。
常规止血伤口敷料(诸如,可吸收止血器、Surgicel可吸收止血器、Surgicel可吸收止血器以及细纤维可吸收止血器,全部可得自Johnson&Johnson公司的Ethicon公司(Somerville,N.J.)分部的Johnson&Johnson WoundManagement Worldwide;以及可吸收纤维素外科敷料,得自Becton Dickinsonand Company(Morris Plains,N.J.))中使用的基底或织物均可用于制备根据本发明的伤口敷料。在某些实施方案中,本发明的伤口敷料有效提供和保持严重出血情况下的止血。如本文所用,严重出血是指包括其中以相对较高速率失去相对较大体积血液的那些出血情况。严重出血的示例包括(但不限于)因动脉穿刺、肝脏切除、钝性肝损伤、钝性脾损伤、主动脉瘤导致的出血、得自具有过度抗凝作用的患者的出血、或者得自具有凝血病(例如血友病)的患者的出血。与在(如)诊断性或介入性血管内手术之后的当前护理标准相比,此类伤口敷料允许患者较快地走动。
本发明的新型层压工艺将使用常规压力层压工艺设备和常规膜挤出工艺设备。膜挤出工艺设备将在足够的温度、压力和挤出速度下运行,以有效地提供所需的膜和给定聚合物的输出速率。例如,可将挤出工艺设备的温度保持在通常为100℃至约300℃、更通常为120℃至约250℃、并且优选为约160℃至约220℃的温度下。本发明工艺的膜输出速率的范围通常为约1fpm至约2,000fpm,更通常为约5fpm至约100fpm,并且优选为约6fpm至约20fpm。在本发明工艺中挤出的膜的厚度将足以为层压结构提供有效的性能。这些性能包括拉伸强度、抗撕裂性和刚度。通常,膜厚度的范围为约0.1密耳至约10密耳,更通常为约0.2密耳至约5.0密耳,并且优选为约1.0密耳至约3.0密耳。挤出机压力通常为约100psi至约5,000psi,更通常为约500psi至约3,000psi,并且优选为约1,000psi至约2,000psi。
从工艺设备挤出之后,将挤出的膜优选在收卷辊上卷起,其中相邻的层用硅树脂防粘纸隔开。然后在常规切割设备上将挤出的膜切成一定长度。然后将切割的膜带到层压站或储存在氮气下。使用常规层压器械,使用足够的热量和压力将膜层压到合适的基底,以使膜有效地层压到基底。膜挤出和层压步骤之间的时间通常为约5秒至约10分钟,更通常为约1分钟至约8分钟,并且优选为约2分钟至约5分钟。层压温度通常为约60℃至约140℃,更通常为约80℃至约130℃,并且优选为约100℃至约120℃。层压(Godet速度)通常为约0.1fpm至约10fpm,更通常为约0.2fpm至约5.0fpm,并且优选为约0.5fpm至约2.0fpm。
如果需要,可将挤出的膜移动到层压器械上,而无卷起和切割膜的中间步骤。在工艺的该变体中,膜的挤出和层压步骤之间的时间通常为约1秒至约10秒,更通常为约2秒至约6秒,并且优选为约3秒至约5秒。在该连续工艺中层压之后,可将层压体卷起或切割成离散的部分。
在层压时挤出的聚合物膜需要具有约0%至约10%、更优选0%至6%并且最优选0%至4%的结晶度。
本发明的新型层压方法和由此类工艺制得的层压医疗装置构造具有许多优点。这些优点包括不需要粘合剂层/膜用于粘结,可以使用低加工温度(120℃或更低)来将可吸收或不可吸收聚合物膜粘结到热敏基底,这将防止基底变形和收缩并且最小化化学降解。缺乏附加粘结层将降低不良组织反应(释放较少降解产物,诸如游离酸)的风险,提高生物相容性,并且降低装置刚度—增加柔韧性。使用本发明的方法还将显著降低生产成本并极大简化此类医疗装置的制造步骤。
以下实施例示出本发明的原理和实践,但不限于此:
实施例1
嵌段75/25Gly/Cap共聚物的合成
在本实施例中使用的嵌段共聚物是通过先前在名称为“Suture,aNew Ultra-Pliable Absorbable Monofilament Suture”Biomaterials,第16卷,第15期,1995年10月,第1141-1148页的论文中描述的方法制得的。其合成也在专利文献诸如US 5,133,739A和US 8,278,409B2中有所描述。这些参考文献的公开内容以引入方式并入本文。
最终的干燥树脂是嵌段A-B-A型共聚物,其具有75摩尔%的聚合乙交酯和25摩尔%的聚合ε-己内酯单元,如通过核磁共振(NMR)方法确定。干燥树脂具有1.71dL/g的特性粘度(IV),如在六氟异丙醇中在25℃下和在0.10g/dL的浓度下测量。凝胶渗透色谱法(GPC)分析显示重均分子量为大约85,000道尔顿。干燥树脂的玻璃化转变温度Tg为4.4℃,熔点为194℃,并且熔化热ΔHm为45.3J/g,如通过差示扫描量热法(DSC)使用第一加热数据和10℃/分钟的加热速率确定。广角X射线衍射(WAXD)分析显示干燥树脂的结晶度为45%。
实施例2
实施例1的干燥树脂的所择量热特性
使用配备有自动取样器的来自TA Instruments(New Castle,DE)的型号Q20-3290量热计进行DSC测量。在各个实验中,将如实施例1中所描述的干燥的热处理共聚物树脂置于DSC盘中,在低于负(-)60℃下淬火,并以10℃/分钟的恒定加热速率加热,以确定其量热特性(第一加热特性);这些量热特性包括玻璃化转变温度Tg、熔点Tm和熔化热ΔHm。根据第二加热测量(将树脂在240℃下熔融,随后在低于–60℃淬火),获得Tg、Tm、Tc(结晶温度)和ΔHm的值,这些值独立于先前热处理史。表1中列出了使用量热测量获得的数据。
表1
用于描述本发明的在实施例1的共聚物上的第一加热和第二加热运行期间的DSC
结果
还通过等温结晶方法评估了结晶特征。使用DSC技术进行实施例1的共聚物的等温结晶动力学分析。将如实施例1中所描述的干燥的热处理共聚物树脂置于DSC盘内,并且在240℃下完全熔融2分钟,以去除样品中存在的任何成核位点。随后,使测试材料快速冷却/淬火(-60℃/分钟的冷却速率)至所需的结晶温度。等温方法假设在样品达到测试温度之前不发生结晶;获得的数据支持该假设。在50℃至110℃的广泛温度范围内表征了树脂的结晶行为。根据随着时间在热流中的变化监控等温结晶动力学(在恒定温度下)。对等温热流曲线积分,以确定结晶度参数。值得注意的是等温DSC运行以随机化次序进行,以避免任何偏差。
随着时间推移的结晶度的发展状况可由结晶程度α来评价,该结晶程度通过如下的比率表示
其中dQ/dt是相应的热流;dHt是时间t时DSC曲线和时间轴之间的部分面积;并且dH∞是峰下总面积并对应于结晶总热。结晶程度α是随后在时间t时形成的结晶体积分数。
在执行热流/时间曲线的积分后,可确定半结晶时间t1/2。半结晶时间是达到在等温运行期间发展的结晶度总量的50百分比所需的时间。为了表示结晶动力学,根据结晶温度呈现倒数半结晶时间。下表2中示出了等温测量的数据。在大约100℃下观察到所检查树脂的最快速动力学。
表2
用于描述本发明的在实施例1的共聚物上的等温结晶运行期间的DSC结果
实施例3
通过熔体挤出实施例1的树脂而形成膜
使用由Davis Standard公司(Pawcatuck,CT 06379,U.S.A)制造的装有膜模具的KN125型熔体挤出机对实施例1的树脂实施熔膜挤出。在所有膜挤出运行中使用6密耳的模隙。不同机筒区域中的挤出机温度在180至210℃范围内,其中模具温度保持在220℃。对于1密耳厚的膜,将螺杆速度设定为15.8rpm,其中将拉出辊的线速度保持在10.4fpm。相似地,对于2密耳厚的膜,螺杆速度为19.1rpm,同时将拉出辊的线速度保持在6.0fpm。在膜收集期间,使用从辊架分配的硅树脂防粘纸将卷绕在收卷辊上的各膜层分离。挤出后,将具有对应硅树脂防粘纸的膜切割成合适的长度,并在挤出后立即将其带到层压器械,或储存在氮气下更长的时间。将所产生的膜的厚度确定为1.0密耳和2.0密耳。
实施例4:
实施例3中制得的膜的结晶特性的检查
使用第一加热和第二加热DSC方法确定实施例3的未退火和退火膜的量热特性。下表3中示出了结果的汇总。
表3:
实施例3中的未退火和退火的2密耳挤出膜的热(量热)特性
*第二加热DSC测量始于在240℃下将树脂熔化2分钟,随后淬火(-60℃/分钟)至-60℃,然后以10℃/分钟进行恒定加热扫描
**结晶度百分比由100%结晶的PGA材料的熔化热计算(ΔH m=12KJ/mol,相当于103J/g);[参考文献:“Biomedical Engineering Fundamentals”,Joseph D.Bronzino和DonaldR.Peterson;“Wound ClosureBiomaterials andDevices”,Chih-Chang Chu和J.Anthony von编辑;“Biomaterials:Principles andPractices”,Joyce Y.Wong、JosephD.Bronzino和Donald R.编辑;“Biotextiles as Medical Implants”,M WKing、B S Gupta和R Guidoin编辑;“The Biomedical Engineering Handbook1”,Joseph D Bronzino;“Surfaces and Interfacesfor Biomaterials”,P Vadgama编辑]
如表3所示,实施例4中制得的未退火和退火膜均含有相对高水平的结晶度(分别为46%和47%)以及高熔点(均为约191℃),如根据第一加热测量确定。根据第二加热扫描,两种膜均显示出较低的结晶度(约40%)。这是因为在实验过程中,首先擦除了热历史(使样品进入无定形相),接下来是从淬火开始仅在加热扫描期间以10℃/分钟的相对快的加热速率产生结晶度的步骤。
为了进一步了解这些膜的结晶动力学,我们进行了以下一组实验。将实施例3中制得的膜片置于DSC盘中,加热至240℃保持2分钟以擦除任何热历史,然后迅速降至室温,在此温度下其度过一定的时间形成晶体形态。在该“停留”期后,将样品以10℃/分钟加热至其熔点240℃以上。在该加热步骤(第一加热测量)期间,将发生另外的结晶,然后进行随后的熔融转变。熔化热(熔融转变)下的峰面积与结晶热之间的差异与样品暴露于室温时产生的结晶度成正比。下表4中给出了该组实验的数据汇总。表4中的最后一列示出了在给定样品在室温下停留时间期间产生的结晶度。
表4:
通过DSC方法将实施例1的75/25Gly/Cap共聚物树脂作为室温下停留时间的函数
的等温结晶研究
*第一加热DSC测量始于在240℃下将树脂熔化2分钟,随后淬火(-60℃/分钟)至22℃,并在该温度下等温停留给定的时间,然后以10℃/分钟进行恒定加热扫描
**结晶度百分比由100%结晶的PGA材料的熔化热计算(ΔHm=12KJ/mol,相当于103J/g);[参考文献:“Biomedical Engineering Fundamentals”,Joseph D.Bronzino和DonaldR.Peterson;“WoundClosureBiomaterials andDevices”,Chih-Chang Chu和J.Anthony von编辑;“Biomaterials:Principles andPractices”,Joyce Y.Wong、JosephD.Bronzino和DonaldR.编辑;“Biotextiles as Medical Implants”,M WKing、B S Gupta和R Guidoin编辑;“The Biomedical Engineering Handbook 1”,Joseph D Bronzino;“Surfaces and Interfacesfor Biomaterials”,P Vadgama编辑]
如表4所示,在10分钟或更短的停留时间内,膜在室温下能够产生的结晶度相对较小(小于7%)。然而,随着停留时间延长,结晶度逐渐增加。另外,在室温下具有较长停留时间的样品在第一加热扫描期间表现出更快或更容易的结晶。这在表4的第三列中指出,因为结晶峰相应地转变为较低温度。
实施例5
具有不同基底和由75/25Gly/Cap摩尔%制得的半结晶膜的复合结构的层压(非本
发明实施例)
将由厚度为1密耳和2密耳(在实施例3中描述)的实施例1的共聚物树脂制得的膜层压到各种ORC基基底(可以商品名SurgicelSurgicelSurgicel得自Ethicon公司)以及用于疝修复应用的聚丙烯(PP)基网上。将膜在室温下老化或熟化;将从实际的膜挤出工艺到层压时间的经过时间设置为至少48小时或更长。使用Godet的加热设置与夹辊的组合完成层压。在范围为120至200℃的各种Godet温度下执行层压。对于1密耳和2密耳的膜,辊速通常保持在0.5和1FPM之间。重要的是要提到低温层压非常需要保持氧化再生纤维素(ORC)材料不降解,对于聚丙烯(PP)网也是如此,以避免任何与热相关的变形。对于ORC系列产品,120℃或以下的温度被认为对于层压是安全的,而145-150℃被认为是聚丙烯基网的上限温度。
尝试将老化的75/25Gly/Cap膜(1密耳和2密耳)在低于150℃的温度下层压到任何基底上都由于立即分层(缺少粘结)而失败。这是因为膜的熔点为191℃。在高于150℃的温度下,基底上存在部分熔化和粘结,但在处理过程中很快发生分层。最重要的是,ORC基基底变黄,表明降解过程开始,而PP网由于大量收缩而严重变形。
实施例6
具有不同基底和在低加工温度下由75/25Gly/Cap摩尔%制得的新挤出的低结晶
度的膜的复合结构的层压(本发明实施例)
如本文所用,术语“新挤出”被定义为意指在挤出步骤后10分钟或更短时间内已层压在基底上的可吸收半结晶聚合物膜。为了在实施例3中先前描述的挤出步骤之后立即检查75/25Gly/Cap膜的层压,切割离开最后一组挤出Godet的矩形聚合物膜片,并将其带到实施例4中所述的层压器械中。接着在每个基底上使用120℃的低Godet温度以下列时间间隔进行一系列层压程序:从膜挤出结束开始2、5、10和30分钟。
出乎意料的是,用时间间隔2、5和10分钟标记的所有膜/基底组合在120℃的低加工温度下都表现出完美的层压(粘结)。然而,在膜挤出后30分钟处理的某些测试组合未产生最佳结果(观察到部分分层)。随后将观察到产生良好层压(2、5和10分钟)的样品置于在室温下供应氮气流的稳定室中72小时以产生另外的晶体形态。在72小时室温老化之后,检查膜/ORC膜/PP-网复合物的处理特性。
使用本发明工艺制得的产生层压复合物表现出优异的处理特性,并且在标记为2、5和10分钟的任何制备的组合中都未观察到75/25Gly/Cap膜的分层。另外,未观察到ORC或PP织物变形或起皱。使用广泛的物理处理,包括重复弯曲工序、拉动和其它主观处理操作,膜/ORC膜/PP结构未撕裂或显示任何损坏迹象。最后,由于120℃的低层压温度,在任何ORC织物中均未观察到变色。
虽然已相对于本发明的详细实施方案示出和描述本发明,但本领域的技术人员将理解,在不脱离所要求保护的本发明的实质和范围的情况下,可对本发明在形式上和细节上作出各种改变。
Claims (32)
1.一种制得层压医疗装置构造的方法,所述方法包括:
a)将半结晶聚合物膜挤出,所述半结晶聚合物膜具有140℃或更高的熔点温度、低于25℃的玻璃化转变温度和结晶度,所述聚合物膜在室温或环境条件下可结晶;
b)通过在已挤出所述聚合物膜后的10分钟内进行热或压力层压步骤,将所述膜直接层压到热敏聚合物基底,以形成层压医疗装置构造,其中所述膜具有10%或更低的结晶度,以便在120℃或更低的温度下将所述膜层压到基底上,其中所述基底不会损坏并且将所述膜有效地层压到所述基底。
2.根据权利要求1所述的方法,其中所述基底选自非织造物、织造物和网。
3.根据权利要求1所述的方法,其中所述聚合物膜包含选自以下各项的聚合物:丙交酯或乙交酯作为主要组分与一种或多种其它组分的共聚物,所述其它组分包括己内酯、聚(对二氧杂环己酮);三亚甲基碳酸酯(TMC)、聚乙二醇和聚醚酯制剂。
4.根据权利要求1所述的方法,其中所述聚合物膜包含选自以下各项的聚合物:聚丙烯、聚乙烯、聚对苯二甲酸乙二醇酯和尼龙。
5.根据权利要求1所述的方法,其中所述聚合物膜包含摩尔比分别为75%至25%的乙交酯和ε-己内酯的共聚物。
6.根据权利要求1所述的方法,其中所述基底包含选自以下各项的材料:胶原、藻酸钙、甲壳质、聚酯、聚丙烯、多糖、聚丙烯酸、聚甲基丙烯酸、多胺、聚亚胺、聚酰胺、聚醚、多核苷酸、多核酸、多肽、蛋白质、聚(环氧烷)、聚亚烷基类、聚硫酯、聚硫醚、聚乙烯基类、包含脂质的聚合物、氧化的再生纤维素以及它们的混合物。
7.根据权利要求1所述的方法,其中所述层压是离线执行的。
8.根据权利要求1所述的方法,其中所述层压是在线辊对辊执行的。
9.根据权利要求5所述的方法,其中所述膜结晶度在挤出后的前30分钟内从0%变化到10%,并且对于长于24小时的停留时间变化到20%以上。
10.根据权利要求1所述的方法,其中在层压到所述基底之前,将所述挤出的膜卷起并切成片。
11.一种医疗装置构造,所述医疗装置构造通过权利要求1所述的方法制得。
12.一种制得层压医疗装置构造的方法,所述方法包括:
a)将半结晶聚合物膜挤出,所述半结晶聚合物膜具有140℃或更高的熔点温度、高于25℃的玻璃化转变温度和结晶度,
b)通过在已挤出所述聚合物膜后的10分钟内进行热或压力层压步骤,将所述膜直接层压到热敏聚合物基底,以形成层压医疗装置构造,其中所述膜具有10%或更低的结晶度,以便在120℃或更低的温度下将所述膜层压到基底上,其中所述基底不会损坏并且将所述膜有效地层压到所述基底,并且其中层压的聚合物膜具有至少10%的结晶度。
13.根据权利要求12所述的方法,其中所述基底选自非织造物、织造物和网。
14.根据权利要求12所述的方法,其中所述聚合物膜包含选自以下各项的聚合物:乙交酯或丙交酯的均聚物、它们的共聚物、丙交酯或乙交酯作为主要组分与一种或多种其它组分的共聚物,所述其它组分包括己内酯、聚(对二氧杂环己酮);三亚甲基碳酸酯(TMC)、聚乙二醇和聚醚酯制剂。
15.根据权利要求12所述的方法,其中所述基底包含选自以下各项的材料:胶原、藻酸钙、甲壳质、聚酯、聚丙烯、多糖、聚丙烯酸、聚甲基丙烯酸、多胺、聚亚胺、聚酰胺、聚醚、多核苷酸、聚核酸、多肽、蛋白质、聚(环氧烷)、聚亚烷基类、聚硫酯、聚硫醚、聚乙烯基类、包含脂质的聚合物、氧化的再生纤维素以及它们的混合物。
16.根据权利要求12所述的方法,其中所述聚合物膜包含选自以下各项的聚合物:聚丙烯、聚乙烯、聚对苯二甲酸乙二醇酯和尼龙。
17.根据权利要求12所述的方法,其中所述层压是离线执行的。
18.根据权利要求12所述的方法,其中所述层压是在线辊对辊执行的。
19.根据权利要求12所述的方法,其中在层压到所述基底之前,将所述挤出的膜卷起并切成片。
20.一种医疗装置构造,所述医疗装置构造通过权利要求12所述的方法制得。
21.一种将聚合物膜层压到基底的方法,所述方法包括:
a)将熔融温度为140℃或更高的聚合物转移到装有缝模的熔体挤出机的料斗中,其中机筒和模具温度在高于所述聚合物的所述熔融温度10℃的范围内;
b)将所述聚合物通过所述缝模挤出,从而形成膜;
c)将所述膜拉伸0.8倍至10倍,使得所述膜的厚度在0.01密耳和10密耳之间;
d)在步骤c)下的所述膜挤出后0和10分钟之间的时间间隔中,其中所述聚合物膜具有10%或更低的结晶度,在挤出的聚合物膜和聚合物基底之间提供接触;以及,
e)在120℃或更低的温度下热压所述膜和所述基底,以形成层压构造。
22.根据权利要求21所述的方法,其中所述基底包括选自以下各项的聚合物基底:非织造物、织造物和网。
23.根据权利要求21所述的方法,其中所述聚合物膜包含选自以下各项的聚合物:乙交酯或丙交酯的均聚物、它们的共聚物、丙交酯或乙交酯作为主要组分与一种或多种其它组分的共聚物,所述其它组分包括己内酯、聚(对二氧杂环己酮);三亚甲基碳酸酯(TMC)、聚乙二醇和聚醚酯制剂。
24.根据权利要求21所述的方法,其中所述聚合物膜包含选自以下各项的聚合物:聚丙烯、聚乙烯、聚对苯二甲酸乙二醇酯和尼龙。
25.根据权利要求21所述的方法,其中所述聚合物膜包含摩尔比分别为75%至25%的乙交酯和ε-己内酯的共聚物。
26.根据权利要求21所述的方法,其中所述基底包含选自以下各项的材料:胶原、藻酸钙、甲壳质、聚酯、聚丙烯、多糖、聚丙烯酸、聚甲基丙烯酸、多胺、聚亚胺、聚酰胺、聚醚、多核苷酸、聚核酸、多肽、蛋白质、聚(环氧烷)、聚亚烷基类、聚硫酯、聚硫醚、聚乙烯基类、包含脂质的聚合物、氧化的再生纤维素以及它们的混合物。
27.根据权利要求21所述的方法,其中所述层压是离线执行的。
28.根据权利要求21所述的方法,其中所述层压是在线辊对辊执行的。
29.根据权利要求25所述的方法,其中所述膜结晶度在挤出后的前30分钟内从0%变化到10%,并且对于长于24小时的停留时间变化到20%以上。
30.根据权利要求21所述的方法,其中在层压到所述基底之前,将所述挤出的膜卷起并切成片。
31.根据权利要求21所述的方法,其中层压的聚合物膜具有至少10%的结晶度。
32.一种医疗装置构造,所述医疗装置构造通过权利要求21所述的方法制得。
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