CN105120910B - 用于在医疗器械内原位形成材料的方法 - Google Patents
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Abstract
描述了用于通过如下方式在原位医疗器械中形成材料的方法:在将可聚合溶液从其储存容器转移到原位医疗器械内的空间的过程中或者之后,引发水性溶液中的水溶性聚合物前体的聚合。储存的具有水溶性前体的水性溶液不含自由基引发剂,在水性溶液被转移到原位医疗器械内部的空间的过程中或之后,所述自由基引发剂以粉末形式被引入到水性溶液中。该储存和递送***为储存的水性溶液提供更好的稳定性,使其能够储存在环境温度下,并相对于现有原位聚合体系中所用的溶液提供延长的保存寿命。仅仅对一种水性溶液进行储存和递送/传输的灵活性而不是需要使用两种不同溶液,也是一个好处。
Description
背景技术
本申请要求2013年3月14日提交的题为“Method for Forming Materials InSitu Within a Medical Device(用于在医疗器械内原位形成材料的方法)”的美国临时专利申请第61/785,445号的优先权,其全文通过引用结合入本文。
腹部腹主动脉瘤(AAA)是在主动脉中的弱化区域,其在接近腹部区域形成球状凸出或囊。随着血液流动通过主动脉,血压推压弱化壁,导致其扩张并且常常破裂。破裂的AAA在美国是一个主要死亡原因。
过去,夹具和开放性手术是用于AAA的传统介入疗法。近来,将移植物(有时出于增加稳定性具有支架)放置在动脉瘤上,以降低动脉瘤壁上的压力并防止其发生扩张和破裂。
最近,描述了这样的***,其中,通过微创外科手术(MIS)技术的方式,将器械的可膨胀元件引入到动脉瘤囊中,例如采用出于该目的引入患者内的导丝,指引通过人体患者的脉管***。将可流动前体材料引入可膨胀元件中,前体材料发生化学反应并引起可膨胀元件的膨胀并与动脉瘤囊的形状相一致。随着材料硬化,它们将可膨胀材料固定在患者体内的适当位置并使得动脉瘤稳定化。参见例如,美国专利公开第7,872,068号和第8,044,137号,以及U.S.2006/0222596,其全文通过引用结合入本文。可膨胀元件可以是例如单壁或双壁气球或者可充气套囊。提供了具有可充气或可膨胀元件的器械的其他例子,例如,参见PCT申请公开号WO 00/51522,美国专利公开号5,334,024、5,330,528、6,1312,462、6,964,667、7,001,431、2004/0204755和2006/0025853A1,其全文通过引用结合入本文。可流动前体材料通常是聚合物前体,其聚合并交联以形成水凝胶。一种优选类型的聚合物前体是能够通过自由基聚合发生聚合的材料。通常,这涉及两种预聚物的聚合/交联,它们分别具有末端反应性基团,其易于发生自由基聚合,例如丙烯酸酯和甲基丙烯酸脂。
通过将两种预聚物与热活化的低温自由基引发剂和引发剂催化剂在生理温度下结合,来实现聚合。
为了避免过早聚合,即在所有组分混合并使得它们在可膨胀器械内原位聚合之前,通常将组分储存在两种分开的水性溶液中,一种溶液包含一种聚合物前体和自由基引发剂,另一种溶液包含另一种聚合物前体和引发剂催化剂。以这种方式,将两种聚合物前体保持分开,也将自由基引发剂和引发剂催化剂保持分开。
在实践中,两种溶液同时递送然后混合,在歧管中离体或者是在可膨胀器械自身中。
由于热活化的低温自由基引发剂的不稳定性,含组分的溶液必须一定要保持冷冻,即零摄氏度或更低,直至使用。即使如此,器械或者包含此类溶液的试剂盒的可用保存寿命也仅有12-18个月。
必须将溶液保持冷冻是一个严重的实践缺陷,因为溶液无法容易地解冻并当具有AAA的患者需要立即处理时尽快地待用,特别是由于引发剂的热活化导致无法使用采用大温差的常规技术(例如热水或微波解冻)来进行快速解冻。
会希望具有这样的材料和用于此类材料的方法,使得用于处理的水性溶液可以储存在环境温度或者接近环境温度,实现当需要时的立即使用,并且具有至少2年的可用保存寿命。
还会希望能够仅给药一种溶液而不是两种,从而避免在歧管或其他装置中进行混合并确保聚合的材料的均匀性的必要性。
发明内容
需要的是一种使得AAA治疗器械稳定化的改进方法。本文描述了这些方法,包括使得植入医疗器械稳定化的材料和方法,通过引入可流动前体材料,所述前体材料使得器械的可膨胀元件膨胀以将器械固定到位,然后前体硬化以将器械保持到位。先前的器械和方法详细参见例如上文所引用的美国专利第8,044,137号,其全文通过引用结合入本文。
本文所述的实施方式提供了这样的方法,其实现了植入的医疗器械的更简单且更实用的稳定化,特别是消除了保持材料冷冻直至使用的需求,增加了保存寿命,并且能够仅使用一种溶液来引发过程。
具体来说,一种实施方式涉及通过增加患者体内的医疗器械的可膨胀元件的体积,来原位形成材料的方法,其包括:
a.将可流动水性溶液引入到与可膨胀元件内部空间连通的管中,或者直接引入到可膨胀元件中,所述可流动水性溶液包含第一和第二水溶性聚合物前体以及任选的引发剂催化剂,每种水溶性聚合物前体具有末端官能团,
b.将粉末形式的热活化的低温自由基引发剂引入到步骤(a)的可流动水性溶液中,
c.使得自由基引发剂在可流动水性溶液中溶解,
d.如果没有在步骤(a)中预先引入的话,则将引发剂催化剂引入步骤(c)的溶液中,以及
e.使得聚合物前体上的官能团发生共价键合,以在可膨胀元件内的空间中形成固态且基本不可生物降解的材料。
可流动水性溶液可由第一和第二源溶液的混合物形成,它们分别被引入到分开的填充管中,每种源溶液包含一种聚合物前体,或者如果采用同时包含第一和第二聚合物前体的仅仅一种源溶液,则可流动水性溶液与所述一种源溶液相同,并引入到单个填充管中。催化剂可存在于源溶液中,或者在引入引发剂之前或之后添加。
该方法实现了使得引入的源溶液不含自由基引发剂,作为替代,自由基引发剂保持粉末形式,并仅在需要聚合的时候引入到可流动水性溶液中。该粉末形式的材料可存在于可膨胀元件上游的滤器中,存在于可膨胀元件自身,或者存在于与可膨胀元件连通的容器中。作为源溶液中不存在自由基引发剂的结果,可以并且希望在一种源溶液中结合两种聚合物前体,从而给药单种源溶液以引发聚合过程。
附图说明
图1显示现有技术设备的示意性截面图。
图2A显示滤器单元的一个实施方式的示意性截面图。
图2B显示滤器单元的另一个实施方式的示意性截面图。
图2C显示集成歧管/滤器单元的一个实施方式的示意性截面图。
图3显示可膨胀元件的一个实施方式的示意性截面图。
图4显示用于实施本文所述方法的设备的一个实施方式的示意性截面图。
图5显示用于实施本文所述方法的设备的另一个实施方式的示意性截面图。
图6显示用于实施本文所述方法的设备的另一个实施方式的示意性截面图。
图7显示图6的可膨胀元件的封闭示意性截面图。
图8显示用于实施本文所述方法的设备的另一个实施方式的部分示意性截面图。
附图旨在描述各组件及其相互关系。组件不是按比例绘制的。
具体实施方式
如上所述,先前用于治疗AAA的方法包括通过增加医疗器械的可膨胀元件的体积,来原位形成材料。当通过可流动材料使得可膨胀元件发生膨胀时,可膨胀元件与装纳其的动脉瘤的形状一致,并且一旦硬化,将医疗器械固定到位。通过水性溶液中的两种聚合物前体,在存在热活化的自由基引发剂和引发剂催化剂的情况下的自由基聚合,来形成材料。在例如,包含单壁或双壁气球的植入物内进行聚合。
图1显示用于实施先前方法的典型现有技术设备10的实施方式。两种溶液13A、13B位于容器11A、11B中,例如注射器,其与填充管12A、12B连通。在该构造中,一种溶液包含第一聚合物前体以及引发剂或催化剂,另一种溶液包含第二聚合物前体以及引发剂和催化剂中的另一种。将溶液13A、13B加压递送到歧管16,它们在其中混合。歧管可包括各种结构以确保完全混合。然后将所得到的溶液递送通过管14到达可膨胀元件15,在其中进行聚合,可膨胀元件发生膨胀,与围绕的动脉瘤(未示出)的形状相一致,随时间的推移进行聚合。一旦结束溶液递送(溶液注入的终止可以基于与加压管(例如管14)附连的压力传感器,或者可以基于对所需占据的动脉瘤空间进行填充所需的预测量或计算体积所实现的递送),则可以将管14从可膨胀元件撤回,实现将聚合化的混合物密封在可膨胀元件15内。通常通过导丝上放到位的导管的方式,将包含可膨胀元件的医疗器械递送到患者体内的动脉瘤的位置。在另一个实施方式中,不存在歧管,两种溶液在可膨胀元件中混合。
在待引入的一种溶液中存在引发剂的问题在于,溶液(因而整个设备)需要保持冷冻,并且仅在紧接递送到导管对患者进行治疗之前才解冻。涉及大温差,例如热水或微波处理的常规方式的解冻是不可行的,这是由于引发剂的热活化导致的。在环境温度下,溶液中的引发剂是不稳定的,会导致聚合物前体的降级,例如和包括过早聚合,导致不可接受的保存寿命。
现在令人惊讶的发现,通过消除溶液中的引发剂并在稍后过程中将其以粉末形式引入,(i)可以避免将含有溶液的设备储存在冷冻温度;(ii)可以改善整体保存寿命;(iii)可以将两种聚合物前体结合在一种溶液中进行递送,极大地简化了工艺;以及(iv)所得到的水凝胶的质量与通过先前方法制备的质量基本相同。
因此,在其最宽方面,描述的方法包括通过增加患者体内的医疗器械的可膨胀元件的体积,来原位形成材料的方法,其包括:
a.将可流动水性溶液引入到与可膨胀元件内部空间连通的管中,或者直接引入到可膨胀元件中,所述可流动水性溶液包含第一和第二水溶性聚合物前体以及任选的引发剂催化剂,每种水溶性聚合物前体具有末端官能团,
b.将粉末形式的热活化的低温自由基引发剂引入到步骤(a)的可流动水性溶液中,
c.使得自由基引发剂在可流动水性溶液中溶解,
d.如果没有在步骤(a)中预先引入的话,则将引发剂催化剂引入步骤(c)的溶液中,以及
e.使得聚合物前体上的官能团发生共价键合,以在可膨胀元件内的空间中形成固态且基本不可生物降解的材料。
特别优选的聚合物前体是如下那些,在聚合和交联之后,会导致具有某些所需性质的水凝胶,特别是可溶胀性小于约20%v/v且杨氏模量至少约为100千帕的固态且不可生物降解的材料。为了使得MIS(微创外科手术)过程所需的时间最小化,但是时间足以从可膨胀元件去除填充管,优选形成最终的水凝胶的时间约为30秒至约30分钟,从引发聚合反应开始。通过溶液中的两种聚合物前体、引发剂和催化剂,来引发聚合反应。
优选聚合物前体是水溶性的,相互可溶,具有类似的聚合反应性,以确保水凝胶是无规共聚物并具有末端官能团。特别优选的是如下聚合物前体,其包含聚环氧乙烷单元(即聚乙二醇(PEG)),具有末端丙烯酸酯或甲基丙烯酸酯官能团。还优选第一聚合物前体是线型的,第二聚合物前体是支化的。线型聚合物前体为水凝胶提供长链、耐用和灵活基础,支化聚合物前体为水凝胶提供高度交联,其具有含所需可溶胀性和硬度的网络结构。特别优选的线型聚合物前体是聚乙二醇,其末端衍生有2个丙烯酸酯基团并具有约20-50千道尔顿(最优选约35千道尔顿)的分子量。特别优选的支化聚合物前体是低聚支化聚乙二醇,其末端衍生有3个丙烯酸酯基团并具有约800道尔顿至1.2千道尔顿(最优选约1千道尔顿)的分子量。支化聚合物前体与线型聚合物的摩尔比优选约为200:1至1000:1,最优选约400:1。
热活化的低温自由基引发剂会在生理体温或接近生理体温引发自由基交联反应。特别优选的引发剂是过硫酸钠、过硫酸钾和过硫酸铵。过硫酸铵是特别优选的原因在于它的高水溶性,从而确保其在所述过程中的完全溶解性。
引发剂催化剂用于通过与引发剂反应来引发聚合反应。优选的催化剂包括三乙醇胺和四甲基乙二胺。三乙醇胺是特别优选的。通常优选引发剂与催化剂以约等摩尔量存在,支化聚合物前体与引发剂的摩尔比约为2:1至约15:1,优选约7:1。
前述组分(两种聚合物前体,以及任选的催化剂)溶解在一种或两种源溶液中,优选溶解在缓冲的水性溶液中,例如磷酸盐缓冲溶液,其具有对于酯键的稳定性是合乎希望的pH,优选中和至略酸性,pH 4-7,并且提供相对于生理条件具有中性渗透压的水凝胶。稍后使得作为粉末的引发剂溶解。充分缓冲的源溶液被用于降低粘度并确保源溶液是可流动的。如果采用两种源溶液,则第一源溶液包含第一聚合物前体,第二源溶液包含第二聚合物前体。催化剂可以存在于源溶液之一中,或者其可以稍后添加,在引入引发剂之前或之后。优选地,催化剂存在于源溶液之一中。此外,源溶液之一通常还包含辐射阻挡(radio-opaque agent)试剂,例如用于荧光显影的泛影酸钠(sodium diatrizoate)。为了易于递送,优选采用约为等体积的两种源溶液。如果仅采用一种源溶液,则存在两种聚合物前体、任选的催化剂以及辐射阻挡试剂。优选地,催化剂存在于源溶液中。
在如图2A所示的一个实施方式中,滤器单元20A包括滤器18。将粉末形式的引发剂17A布置在滤器的上游侧。滤器单元布置在可膨胀元件的上游的管14中。随着可流动水性溶液通过滤器单元,引发剂溶解在其中。
在另一个实施方式中,粉末形式的引发剂17B固定在滤器18的上游侧上。这如图2B所示。可以通过例如将引发剂俘获在海绵或支架中,将其捕集在小孔中或者易蚀固体中,来实现固定。
在如图2C所示的另一个实施方式中,利用两种源溶液,显示将歧管和滤器集成在单个单元20C中。
在图2A-C的前述实施方式中,滤器可以由PTFE、PVDF、聚砜、聚丙烯和其他相容材料构成,其具有足够小的孔,以防止引发剂粉末通过其,但是能够允许溶液在压力下的通过而不造成阻碍。箭头显示流动方向。可以使用各种具有上述性质的市售可得的滤器单元,例如33mm Millex GP 0.22μm滤器。
在如图3所示的另一个实施方式中,粉末形式的引发剂17C布置在可膨胀元件15中。然后,当可流动水性溶液流入可膨胀元件中时,该材料溶于可流动水性溶液中。
用于实施所述方法的设备40的一个实施方式如图4所示。将两种源溶液19A、19B(其分别含有一种聚合物前体,一种源溶液包含催化剂)递送到歧管16,然后将所得到的可流动水性溶液递送到滤器18,所述滤器18具有以粉末形式布置在其上游侧的引发剂17A(或17B),在粉末溶解之后,所得到的溶液通过滤器并被递送到可膨胀元件15。
用于实施所述方法的设备50的另一个实施方式如图5所示。在该实施方式中,仅采用一种源溶液21。该溶液同时包含两种聚合物前体和催化剂,并且被递送到滤器18,所述滤器18具有以粉末形式布置在其上游侧的引发剂17A(或17B),在粉末溶解之后,所得到的溶液通过滤器并被递送到可膨胀元件15。
用于实施所述方法的设备60的另一个实施方式如图6所示。将单个源溶液直接递送到可膨胀元件15,其显示为部分膨胀。将小部分(例如5-10%)体积的递送的溶液26通过管22撤回到含有粉末形式的引发剂17D的容器23(例如注射器)中。在粉末溶解于递送的溶液26之后,所得到的溶液通过管22返回到可膨胀元件中,与可膨胀元件中递送的溶液26混合,使得进行聚合反应。在该实施方式的变化形式中,初始地将两种源溶液递送到可膨胀元件。
图7显示图6的可膨胀元件15在含引发剂的溶液通过管22返回之后的具体实施方式。所得到的溶液24发生聚合。为了确保含引发剂的返回溶液与递送的溶液26在可膨胀元件中的完全混合,管22的远端部分显示为延伸基本到达可膨胀元件的远端。还显示管22的远端部分具有绕着管22的远端部分环状间隔开的多个端口25。以这种方式,通过管22返回的溶液可以与递送的溶液26更完全的混合,以确保更均匀混合的溶液,并得到具有所需性质的均匀水凝胶聚合物。
如上文所述,催化剂可以被结合到源溶液中或者在稍后过程中引入(在引入引发剂之前或之后)。图8显示用于实施本发明的设备80的一个实施方式。在该实施方式中,两个滤器单元20A和27串联连接。滤器单元20A含有引发剂17A(或17B),滤器单元27含有催化剂29。同时包含两种聚合物前体的可流动水性溶液流入滤器单元20A,在其中使得引发剂溶解于其中,然后流入滤器单元27,在其中使得催化剂29溶解于其中,之后递送到可膨胀元件15。在该实施方式的一个变化形式中,两个滤器单元的位置发生调换,使得将催化剂引入到可流动水性溶液中,然后引入引发剂。用于催化剂的滤器单元可以与用于引发剂的滤器单元是相同类型的。
以下实施例仅出于说明目的,并不旨在以任意方式限制其他实施方式的范围。
实施例1
通过如下方式制备第一源溶液:混合约为等重量的0.01M、pH 7.0的磷酸盐缓冲液和乙氧基化(20)三羟甲基丙烷三丙烯酸酯(PEG-T)(美国宾夕法尼亚州埃克斯顿市沙多玛公司(Sartomer Co.,Exton,PA))。通过如下方式制备第二源溶液:在0.01M、pH 7.0的磷酸盐缓冲液中含有4%(w/w)的聚乙二醇二丙烯酸酯35,000Da(PEG-D)(美国德克萨斯州艾伦市键凯科技公司(JenKem Technology,Allen,TX))。分别将22-23mL的这些源溶液转移到封顶双筒注射器的单独的平行室内。将38g的过硫酸铵粉末(APS)置于33mm Millex GP 0.22μm滤器碟的入口侧上,敲打该碟以使得粉末更好地分布。将55mg的三乙醇胺液体(TEA)置于第二33mm Millex GP 0.22μm碟的入口侧上。将多元素静态混合器与双筒注射器的端部相附连。双筒注射器放入分配设备中,其能够分配等体积的两种溶液通过混合器。将含有APS的滤器与混合器附连,依次将含有TEA的滤器与APS滤器的出口相连。每种源溶液分配约15mL(总计30mL),耗时10-20秒,通过混合器以及两个滤器,随后进入置于37摄氏度水浴中的3玻璃瓶中,每个瓶中约10mL。在7分钟后,在第一个瓶中观察到聚合,产生白色固体水凝胶。
实施例2
将等体积(分别约为25mL)的实施例1的第一和第二源溶液进行混合,以形成单个源溶液。由于仅有封顶双筒注射器可用,将所得到的单个源溶液转移到注射器的两个平行室,每个约22-23mL,将混合管与注射器相连,目的不是进行混合,而是提供合适的连接器。将含有27mg的TEA液体的33mm Millex GP 0.22μm滤器碟与混合管的端部附连,并依次将含有32mg的APS粉末的第二33mm Millex GP 0.22μm滤器碟与第一滤器的出口相附连。双筒注射器放入分配设备中,其能够分配等体积的两种溶液。每个筒分配约15mL(总计30mL),耗时10-20秒,通过滤器,随后进入置于37摄氏度水浴中的3玻璃瓶中,每个瓶中约10mL。在9分钟后,在第一个瓶中观察到聚合,产生白色固体水凝胶。
实施例3
重复实施例1,不同之处在于,滤器颠倒,从而使得具有TEA的滤器与混合器的端部相附连,而具有APS的滤器依次与第一滤器的出口相附连。观察到聚合,产生白色固体水凝胶。
实施例4
重复实施例2,不同之处在于,滤器颠倒,从而使得具有APS的滤器与混合管的端部相附连,而具有TEA的滤器依次与第一滤器的出口相附连。观察到聚合,产生白色固体水凝胶。
实施例5
重复实施例1,不同之处在于,将92mg的TEA溶解在第一源溶液中,而不是装纳在滤器中。观察到聚合,产生白色固体水凝胶。
实施例6
重复实施例2,不同之处在于,将45mg的TEA溶解在单个源溶液中,而不是装纳在滤器中。观察到聚合,产生白色固体水凝胶。
实施例7
通过将4.8g的PEG-D和2.4g的泛影酸钠溶于112.8g的0.01M、pH 5.0的磷酸盐缓冲液中,来制备第一源溶液。通过将64.2g的PEG-T和1.128g的三乙醇胺溶于64.8g的0.01M、pH5.0的磷酸盐缓冲液中,来制备第二源溶液。将2.009g的过硫酸铵置于聚氨酯植入袋的内部。将60mL的每种源溶液混合15分钟,以形成单一源溶液。源溶液置于注射器中,并在21摄氏度下注入置物袋内,没有进行搅动以使得水凝胶固化。在22分钟24秒之后观察到完全聚合,产生固体白色水凝胶。
根据本发明的前述实施方式以及用于实施此类实施方式的设备仅是示意性的,并不旨在限制下文所附的权利要求书的范围。上述实施方式的变化、改进和组合对于本领域技术人员是显而易见的,并且包括在本发明中。
Claims (23)
1.一种用于治疗患者体内的动脉瘤的***,所述***包括:
适于递送到患者体内并膨胀的可膨胀元件;
与所述可膨胀元件内的空间流体连通,或者直接导入所述可膨胀元件内的管;
可流动水性溶液,其包含第一和第二水溶性聚合物前体以及任选的引发剂催化剂,每种水溶性聚合物前体具有末端官能团;以及
热活化的低温自由基引发剂,其以粉末形式溶解在所述可流动水性溶液中,如果所述可流动水性溶液不含引发剂催化剂,则将所述引发剂催化剂引入溶液中;
所述溶液和引发剂适于使得所述水溶性聚合物前体上的官能团发生共价键合,以在所述可膨胀元件内的空间中原位形成固态且基本不可生物降解的材料,
其中,所述***还包括:
布置在所述可膨胀元件上游的所述管中的滤器,所述滤器具有上游侧和下游侧;
所述自由基引发剂布置在所述滤器的上游侧上,使得当所述可流动水性溶液通过所述滤器时,所述自由基引发剂溶解在其中。
2.如权利要求1所述的***,其特征在于,所述自由基引发剂固定在所述滤器的上游侧上。
3.如权利要求1所述的***,其特征在于,所述自由基引发剂布置在所述可膨胀元件中,当所述可流动水性溶液进入所述可膨胀元件时,所述自由基引发剂溶解在所述可流动水性溶液中。
4.如权利要求1所述的***,所述***还包括:
与所述可膨胀元件流体连通的容器,所述自由基引发剂布置在所述容器内,所述容器适于使得将一部分的所述可流动水性溶液从所述可膨胀元件撤回进入所述容器中,使得所述自由基引发剂溶解在所述可流动水性溶液中,并且将所得到的混合溶液再次引入到所述可膨胀元件中。
5.如权利要求1所述的***,其特征在于,所述可流动水性溶液是第一和第二源溶液的混合物,所述第一源溶液包含所述第一水溶性聚合物前体,所述第二源溶液包含所述第二水溶性聚合物前体。
6.如权利要求5所述的***,所述***还包括:
歧管,在所述歧管中混合所述第一和第二源溶液,之后与所述自由基引发剂接触。
7.如权利要求6所述的***,其中所述歧管包括集成滤器。
8.如权利要求1所述的***,其特征在于,所述自由基引发剂是过硫酸钠、过硫酸钾或过硫酸铵。
9.如权利要求1所述的***,其特征在于,所述第一水溶性聚合物前体是线型的,所述第二水溶性聚合物前体是支化的。
10.如权利要求9所述的***,其特征在于,所述第一水溶性聚合物前体是线型聚乙二醇,其末端衍生有2个丙烯酸酯基团并具有20-50千道尔顿的分子量,所述第二水溶性聚合物前体是支化低聚聚乙二醇,其末端衍生有3个丙烯酸酯基团并具有800道尔顿至1.2千道尔顿的分子量。
11.如权利要求9所述的***,其特征在于,支化聚合物前体与线型聚合物前体的摩尔比为200:1至1000:1。
12.如权利要求9所述的***,其特征在于,支化聚合物前体与自由基引发剂的摩尔比为2:1至15:1。
13.如权利要求1所述的***,所述自由基引发剂与引发剂催化剂的摩尔比为1:1。
14.如权利要求5所述的***,所述***还包括引发剂催化剂,所述第一或第二源溶液包含所述引发剂催化剂。
15.一种通过增加用于治疗动脉瘤的可膨胀元件的体积来形成植入物的方法,所述方法包括:
a.将可流动水性溶液引入到与所述可膨胀元件内部空间连通的管中,或者直接引入到所述可膨胀元件中,所述可流动水性溶液包含第一和第二水溶性聚合物前体以及任选的引发剂催化剂,每种水溶性聚合物前体具有末端官能团;
b.将粉末形式的热活化的低温自由基引发剂引入到步骤(a)的可流动水性溶液中;
c.使得所述自由基引发剂在所述可流动水性溶液中溶解,其中,在所述可膨胀元件上游的所述管中布置有滤器,所述滤器具有上游侧和下游侧,所述自由基引发剂布置在所述滤器的上游侧,当所述可流动水性溶液通过所述滤器时,所述自由基引发剂溶解在其中;
d.如果没有在步骤(a)中预先引入的话,则将引发剂催化剂引入步骤(c)的溶液中,和
e.使得所述水溶性聚合物前体上的官能团发生共价键合,以在所述可膨胀元件内的空间中形成固态且基本不可生物降解的材料。
16.如权利要求15所述的方法,其特征在于,所述自由基引发剂布置在所述医疗器械的可膨胀元件中,当所述可流动水性溶液进入所述可膨胀元件时,所述自由基引发剂溶解在所述可流动水性溶液中。
17.如权利要求15所述的方法,其特征在于,所述自由基引发剂布置在与所述可膨胀元件连通的容器内,一部分的所述可流动水性溶液从所述可膨胀元件撤回进入所述容器中,使得所述自由基引发剂溶解在所述可流动水性溶液中,并且将所得到的混合溶液再次引入到所述可膨胀元件中。
18.如权利要求15所述的方法,其特征在于,所述可流动水性溶液是由第一和第二源溶液的混合物形成的,所述第一源溶液包含所述第一水溶性聚合物前体,所述第二源溶液包含所述第二水溶性聚合物前体。
19.如权利要求18所述的方法,其特征在于,在歧管中混合所述第一和第二源溶液,之后与所述自由基引发剂接触。
20.如权利要求18所述的方法,其特征在于,在步骤(a)之前,将包含所述第一和第二水溶性聚合物前体的源溶液和所述引发剂催化剂引入到填充管中。
21.如权利要求18所述的方法,其特征在于,所述第一或第二源溶液包含所述引发剂催化剂。
22.如权利要求15所述的方法,其特征在于,在引入所述引发剂之前引入所述引发剂催化剂,或者在引入所述引发剂之后引入所述引发剂催化剂。
23.如权利要求15所述的方法,其特征在于,所述可流动水性溶液还包含辐射阻挡试剂。
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BR112015022688A2 (pt) | 2017-07-18 |
EP2968692A1 (en) | 2016-01-20 |
JP2016511087A (ja) | 2016-04-14 |
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JP6951379B2 (ja) | 2021-10-20 |
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WO2014159093A1 (en) | 2014-10-02 |
CN105120910A (zh) | 2015-12-02 |
JP6533776B2 (ja) | 2019-06-19 |
JP2019136561A (ja) | 2019-08-22 |
US20140277385A1 (en) | 2014-09-18 |
EP2968692B1 (en) | 2020-11-18 |
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US10201638B2 (en) | 2019-02-12 |
BR112015022688A8 (pt) | 2019-11-26 |
EP2968692B8 (en) | 2021-02-24 |
US9289536B2 (en) | 2016-03-22 |
BR112015022688B1 (pt) | 2020-10-06 |
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