CN1114177A - 触发崩解的医疗装置 - Google Patents
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Abstract
本发明提供了由离子交联聚合物,特别是斯坦特固定模、导管和套管构件、塞子和缩窄器构成的医疗装置。本发明的医疗装置可通过用交联离子组合物来处理离子可交联聚合物以得到离子交联聚合物而制得。
本发明的一个重要方面是这些医疗装置可以在所希望的时间使装置暴露于化学触发剂而在体内崩解。化学触发剂为一种通过用非交联离子键合或简单代换来取代在离子交联材料中的交联离子的试剂。
Description
本发明涉及可体内崩解的医疗装置。更具体地讲,本发明涉及用于触发崩解的新型医疗装置体系,该体系包括:一种或多种离子可交联的聚合物,一种或多种交联离子,以及一种或多种能代换交联离子的试剂。这类医疗装置经常用于促进物质的流动。如在输尿管斯坦特固定模中使尿液从肾引流至膀胱,或者在血管移植中用于保持血液流动。通常,这些医疗装置是由生物不降解的耐久性材料制成的,如金属、聚氨酯和聚丙烯酸酯。一般说来,在完成其使命后,这些生物不降解且不可溶性医疗装置需通过侵入过程将其从体内取出,或者,它们长期停留在体内。当这些装置停留在体内时,经常会引起一些医疗并发症,如发炎以及其它异体反应。
近来,已开始采用生物可降解材料如聚酯、聚酐和聚原酸酯来制备这类医疗装置。US5,085,629公开了一种在输尿管斯坦特固定模中生物可降解的丙交酯、乙交酯和ε-己内酯的三元共聚物的应用。在该专利中,生物可降解被定义为包括水解不稳定性。这些聚合物在水存在下会发生水解链断裂,从而形成低分子量水溶性成分。据报导,聚酯会在装置的整个厚度内同时水解(均匀水解),而聚酐和聚原酸酯则从表面开始水解(不均匀水解)。但是,用这些生物可降解材料生产的装置存在一些问题。在任何显著的重量损失之前装置的强度会显著减小。这些装置可能会破裂成大片,从而闭塞使用它们的管道。进行表面水解的生物可降解装置可能逐渐达到一种薄皮构型。这种构型也可造成管道闭塞。半结晶体生物可降解材料也会将不可溶晶体残留物留在体内相当长一段时间。
多年来,在生物医学应用领域一直使用多糖-金属盐体系。EP507604A2中,为防止与外科相关的粘连使用了离子交联的含羧基多糖。该发明的离子交联多糖留在了体内。还没有什么办法来溶解该物料。
在生物医学应用领域也广泛采用水凝胶。US4,941,870;4,286,341和4,878,907中,水凝胶被用作血管修复中强性体基质的涂层。这种水凝胶也停留在体内。Kocavara等(J.Biomed.Mater.Res.vol.1,pp.225~326(1967))报导了一种由用聚酯纤维增强的聚(羟乙基甲基丙烯酸酯)水凝胶制备的吻合输尿管修复假体。这种假体设计成留在体内。
US4,997,443和US4,902,295中,由一种藻酸凝胶前体,一处基质单体和具有Ca2+离子的胰腺细胞及一种基质单体聚合催化剂制备可移植合成胰腺组织。钙-藻酸用来向混合物提供机械整体性,而基质单体被聚合,以后,钙-藻酸经钙螯合作用与柠檬酸盐一起被排出而留下一种多孔基质。使用螯合剂以溶解钙-藻酸在体外发生。钙-藻酸为加工助剂,而不是最后的合成组织装置的结构成员。
多糖-金属盐水凝胶也被用来制备包含胰岛细胞的微凝胶胶囊以生产胰岛素。在Veterans Administration Wadsworth MedicalCenter的工作人员经两年的工作发现,这些胶囊能有效地控制患糖尿病的狗的胰岛素的含量(Scientific American,June1992,pp18~22)。这些胶囊也停留在体内。
US5,057,606中公开了用于制备多糖水凝胶的方法和产品。这些起泡和无泡胶凝产品是将以下第一种组分与第二种组分混合在一起而制得的,第一种组分包含一种水溶性二价或三价金属盐在一种多糖水溶液中的悬浮液,第二种组分包括一种水溶性酸的水溶液,选择性地包括水溶性多糖。这些凝胶停留在体内。
本发明消除了与上述材料相关的各种问题。水解不稳定性并不取决于促进溶解作用。当需要时该装置即通过应用一种试剂来实现崩解,该试剂可通过键合或代换机理排出离子交联成分,该试剂可为阴离子(一价或多价)或阳离子(一价或多价)。在本发明中使用的术语“崩解”包括装置破裂成小颗粒和破裂成水溶性组分。触发崩解消除了用生物易腐蚀材料时观察到的对不同患者的时间不确定性。触发崩解的方法包括:通过饮食将崩解剂给药或触发释放;直接以水溶液形式将该试剂给药于装置上;将该试剂包封在装置中;非肠道给予和灌肠。装置无需显著增大即发生崩解。
本发明提供了一种医疗装置,它包括选自斯坦特固定模、导管或套管构件、塞子和缩窄器的至少一种元件,它们由离子交联聚合物构成。这些医疗装置是通过用交联离子组合物来处理离子可交联聚合物组合物以提供离子交联的材料而制备的。这种处理可能涉及离子可交联聚合物组分的水溶液在一种交联离子的溶液中的交联作用。
本发明的另一种实施方案为一种医疗装置的新颖组合,它包含与至少一种体液结合的离子交联聚合物,所说的体液选自:尿液、胆汁、粪便、血液和肠液。本发明的另一个方面是一种医疗装置,该装置包含选自斯坦特固定模,导管或套管构件、塞子和缩窄器中的至少一种元件,其中所说的医疗装置包括选自尿液、胆汁、粪便、血液和肠液的至少一种体液以及离子交联聚合物。
本发明的再一种实施方案是一种医疗装置,它包括选自由离子交联聚合物构成的斯坦特固定模、导管或套管构件、塞子和缩窄器中的至少一种元件,还包括用一种非交联离子经键合或简单代换来替换交联离子的试剂。本发明还包括一种体内崩解医疗装置的方法,该方法包括用至少一种化学触发剂来处理所说的体内医疗装置。这些化学触发剂可包含代换交联离子的至少一种试剂。
本发明进一步包括一种人体和动物体的医学治疗方法,它包括引入一种医疗装置,该装置包括选自斯坦特固定模、导管或套管构件、塞子和缩窄器中的至少一种元件,其中所述医疗装置包括离子交联聚合物。医疗装置的引入可随后用化学触发剂对医疗装置进行崩解。
本发明的另一个方面是一种由离子交联聚合物水凝胶构成的医疗装置,其中所述水凝胶含水量小于90%。
按照本发明在室温下制备并平衡的装置具有优良的机械强度和弹性。但是,业已发现,高温处理能大大地增强装置的刚性和抗蠕变力。在高于室温通常为40℃~100℃下装置的平衡不仅仅使机械性能得以增强,而且使装置产生新的形状。在热处理步骤期间装置还可能发生稠化。意想不到的是,在返回室温后,这些成形且密度增加的装置仍保持其新的形状和密度。
本发明生产管形制品的方法之一包括:使一种含离子可交联聚合物通过一个模具以形成一个管子,同时泵送一种含交联离子的溶液通过所形成的管子,然后将形成的管子从所说的模具上挤出并进入一种含交联离子的溶液中。在该方法中,交联步骤也可包括装置的成型如以管状装置的湿旋转成形。另一方面,该类装置也可通过将一种潜在的交联成分铸模加工而制成,如一部或两部反应注模体系。术语“管状”不仅包括具有圆形截面的圆柱形装置,而且还包括具有不同截面的装置,只要该制品具有区别管与棒的中空通道。
生产这些装置的另一种方法为常规的铸模技术如反应注模技术,其中将离子可交联聚合物与交联离子混合在一起并将它们置于一个模具中形成所希望构型的制品。
该医疗装置也可在体内形成。这样一种对人体和动物体进行医学治疗的方法包括:向人体和动物体引入一种离子可交联聚合物和一种随后交联所说的聚合物的交联离子,从而形成一种医疗装置,该装置选自斯坦特固定模、导管或套管构件、塞子和缩窄器,其中所说的医疗装置包含离子交联聚合物。
通过将离子交联组合物暴露于代换交联离子的试剂而实现医疗装置的崩解。引入所说的试剂的方法包括:通过患者的饮食,通过非肠道给予引入或触发释放;将一种溶液直接引至装置上或通过装置中本身包封的试剂的释放;或通过灌肠。通过暴露于代换交联离子的试剂,医疗装置可从体内以水溶性成分的形式安全排出体外。崩解发生时所述装置有很小的膨胀。
因而,本发明的医疗装置可以用于人体或动物体的各个系统中,包括但不限于:胃肠、泄尿生殖、心血管、淋巴、耳鼻喉、眼睛、神经、体被和肌肉等系统。
这些包含离子交联聚合物的医疗装置在至少121℃的温度下是可灭菌的。
图1显示了一种用于实施本发明的湿旋转成形装置。
图2显示了作为图1所示设备一部分的的湿旋转成形模具。
图3显示了用于生产本发明的医疗装置的反应注模装置。
本发明的医疗装置是通过用交联离子处理离子可交联聚合物以提供离子交联材料而制得的。
离子可交联聚合物可以是阴离子或阳离子型的,它们可包括但不限于:羧酸、硫盐和胺官能化的聚合物(如聚丙烯酸、聚甲基丙烯酸、聚乙烯胺)、多糖(如藻酸)、果胶酯酸、羧甲基纤维素、透明质酸、肝素、脱乙酰壳多糖、羧甲基脱乙酰壳多糖、羧甲基淀粉、羧甲基糊精、硫酸肝素、硫酸软骨素、阳离子瓜耳胶、阳离子淀粉和它们的盐。优选的离子可交联聚合物为藻酸、果胶酯酸、羧甲基纤维素、透明质酸、脱乙酰壳多糖和它们的盐。最优选的离子可交联聚合物为藻酸、果胶酯酸、透明质酸和它们的盐。离子可交联聚合物分为离子可交联阴离子聚合物和离子可交联阳离子聚合物。其中可采用的离子可交联阴离子聚合物为聚丙烯酸、聚甲基丙烯酸、藻酸、果胶酯酸、羧甲基纤维素、透明质酸、肝素、羧甲基淀粉、羧甲基糊精、硫酸肝素和硫酸软骨素。可采用的离子可交联阳离子聚合物为脱乙酰壳多糖、阳离子瓜尔胶、阳离子淀粉和聚乙烯胺。
交联离子通常分为阴离子或阳离子。适宜的交联离子包括但不限于:阳离子选自钙、镁、钡、锶、硼、铍、铝、铁、铜、钴、铅和银离子;阴离子选自磷酸根、柠檬酸根、硼酸根、琥珀酸根、马来酸根、己二酸根和草酸根离子。广义上讲,阴离子是来自多元有机酸或无机酸。优选的交联阳离子为钙、铁和铝离子。最优选的交联阳离子是钙和铁离子,最优选的交联阴离子为磷酸阴离子。
代换交联离子的适宜试剂包括但不限于:乙二胺四乙酸、乙二胺四乙酸盐、柠檬酸盐、有机磷酸盐(如磷酸纤维素)、无机磷酸盐(例如三聚磷酸五钠、磷酸二氢钾或磷酸氢二钾、焦磷酸钠)和磷酸、羧甲氧基琥珀酸三钠、次氮基三乙酸、马来酸、草酸盐、聚丙烯酸,钠、钾、钙和镁离子。优选的试剂为柠檬酸盐、无机磷酸盐、钠、钾和镁离子。最优选的试剂为无机磷酸盐和镁离子。
该装置可选择性地包括:水;其它的医学治疗添加剂,如防腐剂、抗菌素、抗凝剂、或药物;和用于调节机械性能的添加剂。
可通过使用旋压装置来生产一次成型(Linear)装置或预成型装置,如纤维、棒、管或带,其中,使离子可交联聚合物的溶液通过一个成型模具进入一个含交联离子的交联浴中。如果离子可交联聚合物溶液为水溶液,那么交联后的产品通常被称之为水凝胶。在形成所希望的形状后,可在交联溶液中处理水凝胶使其用于制备或进一步给出一种三维形状。经平衡后,水凝胶将保持其新的三维形状。本发明的装置可以其水凝胶形式或脱水形式使用。在脱水过程中,三维形状仍然保持。
更复杂形状的装置可以使用一部或两部反应注模组合物构成。这些注模组合物通常包含离子可交联聚合物溶液,不溶解或缓慢溶解的交联离子,以及使交联离子溶解的添加剂。当该交联离子溶解和解离离子可交联聚合物溶液凝胶时,该凝胶(如溶剂为水则为水凝胶)可用于制备或进一步加工、交联及成型,这是通过将其浸入交联离子的溶液中。可以使用两部注模系统来使交联离子溶解形成凝胶,在所说的系统中,第二种组分包含一种酸或前酸(pre-acid)如环内酯,它们降低了pH值并使先前不溶的交联离子溶解。
本发明的装置置于体内使用。使用后,经暴露于一种能代换交联离子的试剂的水溶液中,装置即可在体内崩解。
本发明的医疗装置可用于以下的应用中:即常规需除去不可崩解的医疗装置,这类装置使患者不适和/或花费昂贵;以及医疗中暂时需要的装置。这些装置有用的应用实例包括:输尿管、尿道、胆管、回肠和幽门和斯坦特固定模。在这些应用中,现有技术中的斯坦特固定模必须通过第二次侵入过程除去。这给患者带来不适并花费昂贵。本发明的医疗装置便于除去,从而可减少病人的不适和减少花费。本发明的医疗装置也可用于心血管、淋巴、神经、体被、骨骼、肌肉、眼睛、耳鼻喉、口腔、胃肠、泄尿生殖等应用中,其中可有效地控制装置的离子交联部分;还可用于外科手术中,其中需要暂时使用该类装置如作细胞支架(cellular scaffold),手术后最好通过溶解将其除去。其它的医疗装置应用领域还包括:防粘着装置,在耳或窦道管中的导液装置。在牙科及药物应用中的释放装置,外伤治疗如在褥疮治疗中,骨科暂时用支架,亲骨(osteophilic)涂料,神经生长引导,用于吻合的暂时斯坦特固定模,成型传输装置,止血,外科用海棉,脑积水分流,渗析管道,器械涂层,吻合袋,在患者身上胶凝的适于形成的受伤处理装置,暂时用塞子,用于动脉瘤修复的注射可传输暂时填料,合成皮肤,具有医疗添加剂的牙槽添充剂,暂时静脉腔静脉过滤装置,用于传输静脉腔静脉过滤装置的传输胶囊,用于矫形外科的深静脉血栓形成,可溶性肠进料管,肠塞,以及食管裂孔疝斯坦特固定模。这些装置中的任一种也可用于释放药物或营养物等。
本发明消除了先有技术材料有关的问题。并不使用水解不稳定性来增进溶解。该装置一旦需要时即可采用一种代换交联离子的试剂进入装置而实现崩解,触发崩解消除了用生物易腐蚀材料观察到的对不同患者的时间不确定性。触发崩解的方法包括:通过饮食将崩解剂给药或触发释放;直接以水溶液形式将该试剂给药于装置上;将该试剂包封在装置中;非肠道给予;和灌肠。装置无需显著增大即发生崩解。
图1显示了一种用于制备本发明医疗装置的湿旋转设备。注射泵1用于泵送注射器3和4的内容物。注射器3中填充离子可交联聚合物。注射器4填充交联剂,通常为交联离子溶液。注射器3连接到湿旋压模具6上,注射器4连接的侧管7上与模具6相通,交联浴5内含有交联离子溶液,该溶液通过蠕动泵2经管子8循环。
图2显示了湿旋转模具6。模具6有一终端9,通过该终端引入离子可聚合聚合物;还具有另一终端10,从该终端排出的为含聚合物与交联离子的反应产物的制品。交联离子通过侧管7进入,从而在湿旋转模具中形成一个管子,聚合物在管的内和外表面上与交联离子接触。
图3显示了一种用于制备本发明的医疗装置的反应注模设备。该设备具有一个注射泵21,它与注射器22和23相连,注射器22含有离子可交联聚合物和含交联离子的不溶性盐;注射器23含有离子可交联聚合物和pH调节剂。将注射器22和23的内容物注入Y形管24中并通过静态混合器25。Y形管24和静态混合器25均为聚硅氧烷管。然后将静态混合器25的内容物通过静态混合器终端26进入模具30的入口27,模具30有一个管形空腔29和一个棒28从而使得管形装置被模压并胶凝。胶凝的管形装置也可再置于含交联离子的溶液中直至形成充分交联的聚合物。
通过下述实例可进一步描述本发明。
实施例1
向95.10g蒸馏水中加入5.005g的藻酸钠(Sigma平均分子量,macrocystis pyrifera),将它们搅拌直至均匀(大约1小时),加热至90℃并持续45分钟,冷却至室温然后离心分离以除去夹带的空气。然后将藻酸钠溶液装在一个30cc的注射器中,该注射器是连在图1所示的湿旋转模具上的。然后将注射器和模具挂起来(如图1所示)挂至注射泵上,交联溶液注射器包含10%(重量)CaCl2·2H2O的水溶液,蠕动泵进料包含10%(重量)CaCl2·2H2O的水溶液。使用注射泵将一管的藻酸钠湿旋压至一交联浴中,该浴中含有10%(重量)CaCl2·2H2O溶液,在管旋压成后开通蠕动泵以保持促凝剂溶液流过管子。30分钟后,从交联浴中取出管子并将其置于4%(重量)CaCl2·2H2O水溶液中。管子在溶液中放置24小时。
实施例2
如实施例1制备的管段分别被浸入下列水溶液中:a)0.5%的磷酸二氢钾和0.5%的磷酸氢二钾,b)1%的三聚磷酸钠,然后将它们放置过夜。在管瓶a和b中的管子过夜即破裂并崩解。
实施例3
如实施例1制得的管子被穿在铜线上,铜线的两端是首先弯曲而形成猪尾形线的。然后将管子与线一起放在4%(重量)CaCl2·2H2O的水溶液中。在90℃下加热溶液12小时。溶液冷却至室温后,从溶液中取出管和线,将线拉直并使管子从线中取出。管子将保留线的形状,其每一端具有猪尾形且壁厚降低。
实施例4
如实施例3热成形的管子切成的短管段,将它们浸入0.50%(重量)柠檬酸钠水溶液中,在不超过6个小时内管子完全崩解。
实施例5
将约15g的5%(重量)藻酸钠水溶液(如实施例1制备)装在一30cc的注射器中。如图1所示将注射器和模具挂起来挂至注射泵上,交联溶液为10%(重量)Al2(SO4)3·18H2O的水溶液,蠕动泵进料为10%(重量)Al2(SO4)3·18H2O的水溶液。使用注射泵将一管的藻酸钠湿旋压加至一交联浴中,该浴中含有10%(重量)Al2(SO4)3·18H2O的水溶液。在管旋压成后开通蠕动泵以保持促凝剂溶液流过管子。20分钟后,从交联浴中取出管子并将其置于4%(重量)Al2(SO4)3·18H2O水溶液中。管子在该溶液中放置24小时。然后,在4%Al2(SO4)3·18H2O的水溶液中在90℃下加热16小时。然后在0.50%(重量)三聚磷酸钠水溶液中放置过夜,1/4″长的热处理后的管子溶解并分解了。
实施例6
如实施例1制备的5%(重量)藻酸钠水溶液约2cc装入一10cc的注射器中,通过注射器将溶液旋转加入4%(重量)FeCl3水溶液中。溶液立刻凝聚而形成连续的纤维。在FeCl3溶液中静置过夜后,将纤维置于4%(重量)FeCl3的水溶液中于90℃下加热16小时,然后将一片纤维立刻浸入0.50%三聚磷酸钠的水溶液中。该纤维过夜崩解。
实施例7
将如实施例1制备的5%(重量)藻酸钠水溶液从一个10cc注射器中旋转加入4%(重量)SrCl2·6H2O的水溶液中。藻酸溶液立刻胶凝形成纤维。将该纤维放在交联溶液中过夜,以后将纤维在同一交联溶液中于90℃下加热16小时,将一段热处理过的纤维浸入0.5%(重量)三聚磷酸钠的水溶液和0.5%(重量)柠檬酸钠水溶液中。在三聚磷酸钠溶液中的纤维在3小时内崩解。在柠檬酸钠溶液中的纤维过夜崩解。
实施例8
将0.10g的透明质酸钠(Chisso Corp.lot#700910,MW1.35×106)加至0.99g如实例1制备的5%(重量)藻酸钠溶液中。用刮勺搅拌使溶液混合直至透明质酸钠溶液及溶液均匀。将溶液转移至一个2.5cc玻璃注射器中。玻璃注射器上装有一个18号(gauge)1.5″长的针头,样品被旋转加入10%(重量)CaCl2·2H2O水溶液中。样品很快胶凝形成纤维,将该纤维留在交联溶液中1小时。然后将纤维转移至4%CaCl2·2H2O的水溶液中放置过夜。然后再将纤维在4%CaCl2·2H2O的水溶液中加热16小时。纤维在0.5%的三聚磷酸钠水溶液中过夜将崩解并溶解。
实施例9
将1.25g果胶酯酸(GENUpectinic acid Hercules Incorporated,LM1912CSZ)加至47.5g蒸馏水中使其混合。混合过程持续15分钟后,再加入1.25g藻酸钠(Sigma,平均分子量)。混合物再混合30分钟后,离心除去夹带的空气。将约2cc的溶液装入一个2.5cc的注射器中。溶液直接经注射器旋转加入10%CaCl2·2H2O的水溶液中。物料立刻胶凝形成纤维。然后将纤维留在交联溶液中20分钟,之后用蒸馏水将CaCl2·2H2O溶液稀释至4%。样品在4%溶液中放置过夜。在0.5%三聚磷酸钠水溶液中一小片纤维过夜将溶解。
实施例10
将0.10g的透明质酸钠(Chisso Lorporation)加至3.40g蒸馏水中制成2.9%(重量)透明质酸钠水溶液。将0.73g3%的FeCl3水溶液倾倒至透明质酸钠溶液的顶部。透明质酸钠溶液立刻开始胶凝。3小时后取出一小片凝胶并将其浸入0.5%的三聚磷酸钠水溶液中。凝胶过夜崩解。
实施例11
将0.82g的肝素(Fluka)和0.83g的蒸馏水称重加至5ml的管瓶中,搅拌直至肝素溶解,然后离心除去夹带的空气。然后将等体积(约1.6cc)的3%(重量)FeCl3水溶液倾倒至5ml管瓶中肝素溶液的顶部。在室温下静置过夜后,肝素溶液胶凝。在0.5%三聚磷酸钠水溶液中几个小时内该凝胶完全溶解。
实施例12
在搅拌下将4.00g的Mannugel(Kelco International Limited)加至76.00g的蒸馏水中。样品在室温下搅拌1小时后将其在90℃下加热1小时。样品离心处理除去夹带的空气。将纤30cc的Mannugel溶液转移至30cc注射器。如图1注射器连有一个管状模具且置于注射泵上。交联溶液注射器含10%(重量)CaCl2·2H2O水溶液,蠕动泵进料包含10%(重量)CaCl2·2H2O水溶液。使用注射泵将一管的藻酸钠旋转加至包含10%(重量)CaCl2·2H2O水溶液的交联浴中。在管子旋转后,开通蠕动泵以保持交联溶液流动通过该管。20~30分钟后,从交联浴中取出该管并将其置于4%(重量)的CaCl2·2H2O水溶液。将该管留在溶液中过夜。将一段管子在4%(重量)的CaCl2·2H2O溶液中在90℃下加热16小时。将一片热处理过的管子浸入0.5%(重量)的三聚磷酸钠水溶液中,静置过夜管子分解并崩解。
实施例13
搅拌下将5.0g的果胶酯酸(GENUpectinic acid HerculesInc.,LM1912CSZ)加至45.0g的蒸馏水中。再加入16.62g的蒸馏水并混合直至均匀。对溶液离心处理以除去夹带的空气。将约2cc的溶液装入一个2.5cc的注射器中。经一个1.5″长8号针头将溶液旋转加入10%CaCl2·2H2O水溶液中。纤维立刻胶凝。将纤维留在交联浴中45分钟,然后将其转移至4%CaCl2·2H2O水溶液中并过夜。之后在90%下将4%CaCl2·2H2O水溶液中的纤维加热16小时。在0.5%的三聚磷酸钠水溶液中一片纤维充分溶解。
实施例14
将2.40g的CaHPO4分散在76.63g蒸馏水中,随后在搅拌下向悬浮液中加入4.00g的藻酸钠(Sigma,平均分子量)。混合直至均匀后,溶液/悬浮液在90℃下加热20分钟。在American Brand UltrasonicCleaner Bath中再混合30分钟,在室温下静置过夜。然后离心除去夹带的空气。将0.30g的D-葡糖酸内酯(Sigma)加至9.70g5%的藻酸钠水溶液中制成第二种溶液。将两份溶液如图3装在两个10cc的注射器中。使用注射泵使两种溶液通过静态混合器进入一个预定的模具中形成一个10″长的管子,管外经12″,内径0.4″。1.5小时后打开模具取出胶凝后的管子。将该管子置于4%(重量)的CaCl2·2H2O水溶液中。静置过夜后,将一段铜线插入管中,使铜线成型,两端形成猪尾状,然后在90℃下加热16小时。然后将垫成形的管子从铜线中取出。管子保留两端的猪尾状。将一段管子浸入0.5%的三聚磷酸钠水溶液中,管子过夜分解并崩解。
实施例15
将约0.5ml的25%(重量)聚丙烯酸溶液(Polysciences,MW为140,000)加至约5ml的4%(重量)CaCl2·2H2O水溶液中。聚丙烯酸过夜形成一种凝胶。在10cc的0.5%三聚磷酸钠中一小片该凝胶过夜溶解。
实施例16
将625.8g去离子水称重加入1000ml的烧杯中。加入118.2g的藻酸钠(Prolanal LF10/60,Pronova),同时剧烈混合以形成旋涡。10秒钟后混合结束。将溶液在室温下放置过夜。将727.15g的溶液转移至已预热至60℃的Ross Double行星式1夸脱混合器中。在60℃下搅拌溶液30分钟。然后加入54.07g的碱式碳酸钕。继续混合30分钟。混合器冷却至室温后打开。将混合物装入一个30cc的注射器中,离心以除去夹带的空气,然后用于图1的设备上作旋转管。内交联溶液和交联浴为30%(重量)CaCl2·2H2O溶液。在模具(图1中的6)和交联浴(图1中的5)之间的空隙为35.56cm(14英寸)。
然后在去离子水中使藻酸钙管渗析几次以脱除未键合的离子。
实施例17
在一个4盎司罐中将9.0g的SrCl2·6H2O溶解在21.0g去离子水中。将实施例16制备的2英寸长的藻酸钙管浸入罐中的溶液中48小时。然后将藻酸锶管在去离子水中渗析几次以除未键合的锶、钙和氯离子。
实施例18
在一个4盎司的罐中使0.87g的氯化铅与86.13g的去离子水混合并溶解。将实施例16制备的2英寸长的藻酸钙管浸入罐中的溶液中48小时。然后将藻酸铅管在去离子水中渗析几次以除去未键合的铅、钙和氯离子。
实施例19
将0.52g氯化锡加至102.96g的去离子水中以形成饱和溶液。将实施例16制备的2英寸长的藻酸钙管浸在氯化锡溶液中48小时。然后使藻酸锡管在去离子水中渗析几次以除去未键合的离子。
实施例20
将36.0g的氯化钡溶解在84.0g的去离子水中。将实施例16制备的2英寸长的藻酸钙管浸在氯化钡溶液中48小时。然后使藻酸钡管在去离子水中渗析几次以除去未键合的离子。
实施例21
将实施例16~20制得的管子浸入含0.025%(重量)的PO4 3-的合成尿液中。管子对磷酸的敏感性顺序为藻酸钙>藻酸锶>藻酸锡>藻酸铅>藻酸钡。
实施例22
将实施例20制成的藻酸钡管浸入0.3%(重量)的柠檬酸三钠中。6天后,管子肿胀、分裂并部分崩解。
Claims (26)
1.一种医疗装置,它包括:选自斯坦特固定模、导管或套管构件、塞子和缩窄器中的至少一种元件,其中所说的医疗装置包含离子交联聚合物。
2.按权利要求1的医疗装置,其中所说的离子交联聚合物包含至少一种由选自羧酸、硫酸盐和胺官能化的聚合物中的至少一种离子可交联聚合物制备的聚合物。
3.按权利要求1的医疗装置,其中所说的离子交联聚合物包含由至少一种多糖制备的至少一种聚合物。
4.按权利要求1的医疗装置,其中所说的离子交联聚合物包含由至少一种离子可交联阴离子聚合物制备的至少一种聚合物。
5.按权利要求1的医疗装置,其中所说的离子交联聚合物包含由至少一种离子可交联的阳离子聚合物制备的至少一种聚合物。
6.按权利要求4的医疗装置,其中所说的离子交联阴离子聚合物包含至少一种由至少一种离子可交联的聚合物制备的聚合物,其中离子可交联的聚合物选自:聚丙烯酸、聚甲基丙烯酸、藻酸、果胶酯酸、羧甲基纤维素、透明质酸、肝素、羧甲基淀粉、羧甲基糊精、硫酸肝素和硫酸软骨素,及它们的盐。
7.按权利要求5的医疗装置,其中所说的离子交联的阳离子聚合物包含至少一种由离子可交联的聚合物制备的聚合物,其中离子可交联的聚合物选自:脱乙酰壳多糖、阳离子瓜尔胶、阳离子淀粉和聚乙烯胺。
8.按权利要求1的医疗装置,其中所说的离子交联的聚合物是通过一种包含一种或多种阳离子的交联离子进行交联的。
9.按权利要求8的医疗装置,其中所说的一种或多种阳离子选自:钙、镁、钡、锶、硼、铍、铝、铁、铜、钴、铅和银离子。
10.按权利要求1的医疗装置,其中所说的离子交联的聚合物是通过一种包含一种或多种阴离子的交联离子进行交联的。
11.按权利要求10的医疗装置,其中所说的一种或多种阴离子选自:磷酸根、柠檬酸根、硼酸根、琥珀酸根、马来酸根、己二酸根和草酸根离子。
12.按权利要求1~11的医疗装置,它进一步包含选自尿液、胆汁、粪便、血液和肠液的至少一种体液。
13.按权利要求1~11的医疗装置,它进一步包含一种能代换交联离子的试剂。
14.按权利要求13的医疗装置,其中所说的能代换交联离子的试剂包括选自下述试剂中的一种或多种:乙二胺四乙酸、乙二胺四乙酸盐、柠檬酸盐、有机磷酸盐、无机磷酸盐、羧甲氧基琥珀酸三钠、次氮基三乙酸、马来酸、草酸盐、聚丙烯酸、钠、钾、钙和镁。
15.按权利要求14的医疗装置,其中所说的无机磷酸盐选自:三聚磷酸五钠、磷酸二氢钾和磷酸氢二钾、焦磷酸钠和磷酸。
16.一种溶解体内医疗装置的方法,它包括用至少一种化学触-发剂处理所说的体内医疗装置。
17.按权利要求16的方法,其中所说的体内医疗装置包含离子交联的聚合物,并且其中所说的化学触发剂包含至少一种能代换交联离子的试剂。
18.一种对人和动物进行医疗治疗的方法,它包括向人和动物引入权利要求1~15的医疗装置。
19.一种对人和动物进行医疗治疗的方法,它包括向人和动物引入一种离子可交联的聚合物和一种随后与所说聚合物交联的交联离子,从而形成一种选自斯坦特固定模、导管或套管构件、塞子和缩窄器的医疗装置,其中所说的医疗装置包含离子交联聚合物。
20.按权利要求18和19的方法,它进一步包括用一种化学触发剂使所说的医疗装置崩解的步骤。
21.按权利要求20的方法,其中所说的化学触发剂包含至少一种能代换交联离子的试剂。
22.一种医疗装置,它由离子交联聚合物水凝胶构成,所述的水凝胶的含水量小于90%。
23.一种改进含离子交联聚合物的医疗装置的方法该方法包括:在高于约40℃下对装置进行热处理。
24.一种制备管状制品的方法,该方法包括:使一种离子可交联的聚合物通过一个模具形成一个管子,同时泵送一种含交联离子的溶液通过所形成的管子,将形成的管子从模具上挤进一种含交联离子的溶液中,然后任意地对管子进行热处理。
25.医疗装置在人或动物系统中的应用,其中所说的系统选自:胃肠、泌尿生殖、心血管、淋巴、耳鼻喉、眼睛、神经、体被和肌肉系统,其中所说的医疗装置包含离子交联的聚合物。
26.一种包含离子交联的聚合物的医疗装置,其中所说的医疗装置在至少121℃的温度下是可灭菌的。
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CN1114177A true CN1114177A (zh) | 1996-01-03 |
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CN94116589A Pending CN1114177A (zh) | 1993-09-29 | 1994-09-29 | 触发崩解的医疗装置 |
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EP (1) | EP0645150B1 (zh) |
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CN (1) | CN1114177A (zh) |
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AU (1) | AU685152B2 (zh) |
BR (1) | BR9403911A (zh) |
CA (1) | CA2132293C (zh) |
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- 1994-09-23 RU RU94034125A patent/RU2138297C1/ru active
- 1994-09-28 AU AU74296/94A patent/AU685152B2/en not_active Ceased
- 1994-09-28 BR BR9403911A patent/BR9403911A/pt not_active Application Discontinuation
- 1994-09-28 KR KR1019940024420A patent/KR950007801A/ko not_active Application Discontinuation
- 1994-09-29 EP EP94115361A patent/EP0645150B1/en not_active Expired - Lifetime
- 1994-09-29 AT AT94115361T patent/ATE209511T1/de not_active IP Right Cessation
- 1994-09-29 JP JP23498994A patent/JP3703155B2/ja not_active Expired - Fee Related
- 1994-09-29 CN CN94116589A patent/CN1114177A/zh active Pending
- 1994-09-29 DE DE69429227T patent/DE69429227T2/de not_active Expired - Lifetime
- 1994-09-29 PL PL94305241A patent/PL177431B1/pl unknown
- 1994-09-29 DK DK94115361T patent/DK0645150T3/da active
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PL305241A1 (en) | 1995-04-03 |
KR950007801A (ko) | 1995-04-15 |
JPH07163655A (ja) | 1995-06-27 |
RU2138297C1 (ru) | 1999-09-27 |
US5531716A (en) | 1996-07-02 |
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CA2132293A1 (en) | 1995-03-30 |
DE69429227D1 (de) | 2002-01-10 |
DE69429227T2 (de) | 2002-07-25 |
US5650116A (en) | 1997-07-22 |
RU94034125A (ru) | 1996-07-10 |
ATE209511T1 (de) | 2001-12-15 |
US6096018A (en) | 2000-08-01 |
US5820608A (en) | 1998-10-13 |
CA2132293C (en) | 2009-04-07 |
AU7429694A (en) | 1995-04-13 |
JP3703155B2 (ja) | 2005-10-05 |
BR9403911A (pt) | 1995-05-30 |
US6126645A (en) | 2000-10-03 |
PL177431B1 (pl) | 1999-11-30 |
EP0645150A1 (en) | 1995-03-29 |
EP0645150B1 (en) | 2001-11-28 |
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