CN107432979B - 具有改良取回特征的可植入泌尿器械 - Google Patents
具有改良取回特征的可植入泌尿器械 Download PDFInfo
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Abstract
本申请涉及具有改良取回特征的可植入泌尿器械。提供了一种具有取回绳的泌尿医疗器械。所述取回绳具有连接所述器械的近端和相对的远端。在第一实施方案中,所述取回绳被构造成初始限制形式,在部署于患者的膀胱中一段时间后,所述限制形式变化为非限制形式,其中所述取回绳的远端可延伸到所述尿道中以允许通过牵拉所述取回绳从膀胱取出所述器械。所述器械可以包括生物可腐蚀组件,其容许所述取回绳在所述生物可腐蚀组件于体内降解后呈现所述非限制形式。在另一个实施方案中,所述取回绳包括铁磁性材料,其可通过磁力捕捉以促进从所述膀胱移除所述器械。所述铁磁性取回绳可以漂浮于尿液中。
Description
本申请是申请日为2013年05月20日,申请号为201380021047.X,发明名称为“具有改良取回特征的可植入泌尿器械”的申请的分案申请。
相关申请的交叉引用
本专利申请要求2012年5月19日提交的美国临时专利申请第61/649,253号的权益,将该申请以引用其全文的方式并入本文。
发明背景
Cima等人在美国专利申请公开第2011/0152839号中描述的输尿管支架和其它医疗器械(如膀胱内药物递送器械)可以具有取回绳以促进从患者移除器械。取回绳可以称为拴绳、吊环、吊环绳、取回结、撤回绳、拉绳、拉绳缝合线或拉出缝合线。理想上,取回绳允许患者或内科医师通过膀胱和尿道将器械从患者输尿管移除,而不需要膀胱镜检查步骤。
在器械部署在患者中的整个时期,取回绳基本上必须延伸穿过且超出患者的尿道以使患者或医疗专家能够抓住该绳。然而,这可能导致其它问题。例如,患者在(例如)排尿期间或之后会不经意拽到绳子,如果支架在输尿管中移位,将可能导致疼痛。这还可以导致器械被过早地拉出或排出。此外,取回绳可能会造成患者不适,可以干扰排尿期间尿液的流动引导,且/或由于提供细菌迁移路径而可能增加感染的风险。
Taylor等人的美国专利6,258,098公开了用于盲性取回输尿管支架的磁性系统。用弛缓绳将铁磁珠拴系到输尿管支架的近端。当导入支架时,珠从膀胱中的支架悬挂。通过将尖端具有稀土磁体(具有极强磁场)的导管导入膀胱实施取回。磁体吸引珠,且当撤回导管时将充足的力施加于珠上以经由输尿管和尿道将支架拉出。Kuntz的美国专利4,790,809还公开其中将铁磁元件并入输尿管支架的尖端的系统。这些系统均被连到被约束在其部署位置的取回支架。相对地,自由浮动的膀胱内器械不可能或轻易适应与那些磁性系统配合使用。例如,自由浮动器械可以位于膀胱内的任何地方且可能呈现任何取向,导致在盲目探索铁磁性尖端时比采用基本上在已知位置和取向的器械(如支架)要困难得多,即使不实施膀胱镜检查可视化。此外,增加如那些专利所公开的大型铁磁性元件可能导致器械不固定而下沉到膀胱颈并增加铁磁性元件过早吸入尿道和器械不经意从膀胱排出的风险。
因此希望提供促进将部署的泌尿器械从患者选择性取回,同时避免常规取回绳和设计所带来的缺点中的一个或多个的器械和方法。
发明概要
提供了用于将医疗器械从膀胱取回的改良系统和方法。在一个方面,所述系统包括泌尿器械,其被构造以使附接到所述泌尿器械的一个或多个取回绳受控露头。在一个实施方案中,所述取回绳具有连接所述泌尿器械的近端和相对的远端且被构造成初始限制形式,在所述医疗器械在患者的膀胱中部署一段时间后,所述限制形式变化为非限制形式,其中所述至少一个取回绳的远端可延伸到膀胱的尿道中以允许通过牵拉所述至少一个取回绳将所述医疗器械从膀胱取出。在一个特定实施方案中,所述器械还包括生物可腐蚀组件,其可操作以(i)将所述至少一个取回绳维持在其初始限制形式,且(ii)容许所述至少一个取回绳在所述生物可腐蚀组件在体内降解后呈现非限制形式。而且在特定实施方案中,所述系统包括在所述取回绳的远端上的水力盖以促进进入并穿过尿道,以促进所述取回绳的远端从膀胱露头。
在另一方面,所述系统包括具有取回绳的泌尿器械,所述取回绳包括有效促进磁性捕捉所述取回绳的铁磁性材料,如通过与经由患者的尿道插入的尖端含磁体的插管磁力耦合。在特定实施方案中,所述铁磁性取回绳漂浮在膀胱内的尿液中。所述铁磁性取回绳可以或可以不被构造成具有初始限制形式,在所述医疗器械部署在患者的膀胱中一段时间后,所述形式变化为如上所述的非限制形式。
在实施方案中,并入这些系统之一或组合的泌尿器械是药物递送器械。在一个特定实施方案中,所述泌尿器械包括(i)具有至少一个药物蓄存内腔的器械主体,和(ii)定位在所述至少一个药物蓄存内腔中的药物制剂,其中所述器械可在用于将所述泌尿器械保持在膀胱中的保留形状与用于将所述泌尿器械部署穿过患者尿道的低形态形状之间弹性变形。在一个实施方案中,所述泌尿器械被构造以容许当所述器械处于其保留形状时呈现其非限制形式的所述取回绳的远端从膀胱的尿道伸出且从而允许患者或内科医师牵拉所述取回绳的远端并导致所述器械呈现其低形态形状,从而容许经由患者的尿道取出所述器械。
本申请还涉及以下内容:
1)一种医疗器械,其包括:
泌尿器械;和
附接到所述泌尿器械的至少一个取回绳,所述取回绳具有连接所述泌尿器械的近端和相对的远端,
其中所述取回绳被构造成初始限制形式,在所述医疗器械部署于患者的膀胱中一段时间后,所述限制形式变化为非限制形式,其中所述至少一个取回绳的所述远端可延伸到所述膀胱的所述尿道中以允许通过牵拉所述至少一个取回绳将所述医疗器械从膀胱取出。
2)根据1)所述的医疗器械,其还包括至少一个生物可腐蚀组件,其可操作以(i)使所述至少一个取回绳维持其初始限制形式,且(ii)容许所述至少一个取回绳在所述生物可腐蚀组件在体内降解后呈现所述非限制形式。
3)根据2)所述的医疗器械,其还包括通过所述至少一个生物可腐蚀组件附接到所述泌尿器械的水力盖。
4)根据2)所述的医疗器械,其中所述至少一个生物可腐蚀组件含有呈所述限制形式的所述取回绳的至少一部分。
5)根据2)所述的医疗器械,其中所述至少一个生物可腐蚀组件包括包裹在所述泌尿器械周围且将所述取回绳固定在所述泌尿器械的外表面的多个绑带。
6)根据5)所述的医疗器械,其中所述至少一个取回绳是单丝。
7)根据1)所述的医疗器械,其中呈所述限制形式的所述至少一个取回绳的至少一部分是盘绕的。
8)根据7)所述的医疗器械,其中所述盘绕取回绳包括水溶性粘性涂料。
9)根据7)所述的医疗器械,其中所述至少一个取回绳由丝绸或编织聚酯组成。
10)根据1)所述的医疗器械,其中所述至少一个取回绳是漂浮的且包括铁磁性材料。
11)根据1)至10)中任一项所述的医疗器械,其中所述泌尿器械包括膀胱内药物递送器械。
12)根据1)至10)中任一项所述的医疗器械,其中所述泌尿器械包括输尿管支架。
13)根据1)至10)中任一项所述的医疗器械,其中所述泌尿器械包括(i)具有至少一个药物蓄存内腔的器械主体,和(ii)定位在所述至少一个药物蓄存内腔中的药物制剂,其中所述器械可在用于将所述泌尿器械保持在所述膀胱中的保留形状与用于将所述泌尿器械部署穿过患者的尿道的低形态形状之间弹性变形。
14)根据13)所述的医疗器械,其中所述泌尿器械被构造以容许当所述器械呈现其保留形状时呈非限制形式的所述取回绳的远端从所述膀胱的所述尿道伸出并从而允许所述患者或医师牵拉所述取回绳的所述远端且导致所述器械呈现其低形态形状,从而容许经由所述患者的尿道取出所述器械。
15)一种医疗器械,其包括:
泌尿器械;和
附接到所述泌尿器械的取回绳,所述取回绳具有连接所述泌尿器械的近端和相对的远端,
其中所述取回绳包括铁磁性材料。
16)根据15)所述的医疗器械,其中所述取回绳是空心的且所述铁磁性材料含于所述取回绳的内腔中。
17)根据15)所述的医疗器械,其中所述取回绳是实心的且所述铁磁性材料包埋于所述取回绳中。
18)根据15)所述的医疗器械,其中所述铁磁性材料被布置在所述取回绳的外表面上。
19)根据15)至18)中任一项所述的医疗器械,其中所述取回绳漂浮于尿液中。
20)根据15)至18)中任一项所述的医疗器械,其中所述泌尿器械包括膀胱内药物递送器械。
21)根据20)所述的医疗器械,其中所述取回绳漂浮于尿液中。
22)根据15)至18)中任一项所述的医疗器械,其中所述泌尿器械包括输尿管支架。
23)根据22)所述的医疗器械,其中所述取回绳漂浮于尿液中。
24)根据15)至18)中任一项所述的医疗器械,其中所述泌尿器械包括(i)具有至少一个药物蓄存内腔的器械主体,和(ii)定位在所述至少一个药物蓄存内腔中的药物制剂,其中所述器械可在用于将所述泌尿器械保持在所述膀胱中的保留形状与用于将所述泌尿器械部署穿过患者尿道的低形态形状之间弹性变形。
25)根据24)所述的医疗器械,其中所述取回绳漂浮于尿液中。
26)一种从患者移除泌尿器械的方法,其包括:
抓住部署在所述患者中的根据1)至14)中任一项所述的医疗器械的所述至少一个取回绳;且
牵拉所述至少一个取回绳和所述附接的泌尿器械穿过并离开所述患者的所述尿道。
27)根据26)所述的方法,其中所述抓住步骤包括抓住从所述患者尿道伸出的所述取回绳的所述远端部分。
28)一种从患者移除泌尿器械的方法,其包括:
抓住部署在所述患者中的根据15)至25)中任一项所述的医疗器械的所述至少一个取回绳;且
牵拉所述至少一个取回绳和所述附接的泌尿器械穿过并离开所述患者的所述尿道。
29)根据28)所述的方法,其中所述抓住包括将经尿道插入的导管的远端磁力耦合到所述至少一个取回绳。
30)一种医疗器械,其包括:
泌尿器械;和
附接到所述泌尿器械的取回绳,所述取回绳具有连接所述泌尿器械的近端和相对的远端,
其中所述取回绳包括连接到所述远端的水力盖。
31)根据30)所述的医疗器械,其中所述取回绳和所述水力盖不漂浮于尿液中。
附图简述
图1是先前技术泌尿器械的平面视图,该器械可以经过修改以包括本文描述的取回系统的实施方案。
图2是附接有取回绳的膀胱内药物递送器械的一个实施方案的平面视图。
图3A至图3D是示出用于将取回绳附接到一类膀胱内药物递送器械的端件的各个实施方案的透视图。
图3E示出端件的横截面视图,取回绳安装在膀胱内药物递送器械的一个实施方案的管形主体的内腔中。
图4示出药物递送器械的一个实施方案,短取回绳附接到处于保留形状和处于低形态形状的药物递送器械的末端用于经由患者的尿道牵拉所述器械。
图5是泌尿器械的一个实施方案的平面视图,所述泌尿器械具有用取回绳(和水力盖)缠绕的棒形生物可腐蚀组件,用于提供所述取回绳的受控露头。
图6A是泌尿器械的一个实施方案的平面视图,所述泌尿器械具有被生物可腐蚀盖覆盖的盘绕取回绳(和水力盖),用于提供所述取回绳的受控露头。
图6B是盘绕取回绳的一个实施方案的平面视图,所述盘绕取回绳通过施用到线圈上的多个生物可腐蚀粘性材料区域束缚成盘绕构造。
图7是泌尿器械的一个实施方案的平面视图,所述泌尿器械具有生物可腐蚀组件,其具有包埋的取回绳和水力盖,用于提供所述取回绳的受控露头。
图8是泌尿器械的一个实施方案的平面视图,所述泌尿器械具有生物可腐蚀胶囊,其含取回绳和水力盖,用于提供所述取回绳的受控露头。
图9示出泌尿器械的一个实施方案的平面视图,所述泌尿器械具有带水力盖的取回绳,其通过多个环形生物可腐蚀组件沿器械主体的外表面限制在折叠位置,用于提供所述取回绳的受控露头。
图10示出使用取回系统的一个实施方案从膀胱取回泌尿器械的一系列步骤,所述取回系统包括铁磁性取回绳和尖端含磁体的导管器械。
图11示出本文描述的取回绳的两种可能结构。
图12示出取回绳的几种可能结构,所述取回绳包括与本文描述的取回系统配合使用的铁磁性材料。
图13A至图13B示出具有通过生物可腐蚀盖束缚的盘绕取回绳的安慰剂药物递送器械。所述器械被建造并在简单的体外排泄模型中加以测试,证实所述取回绳在生物可腐蚀盖降解后受控露头。
图14至图15图示细长、盘绕或弯曲的膀胱内药物递送器械的实施方案,其中取回绳附接在器械的中间部分或器械的末端。
具体实施方式
提供改良的泌尿器械和从患者取回器械的方法。所述器械和方法有利地包括一个或多个取回特征件,所述特征件允许从患者移除所述器械而不需要实施患者强烈希望避免的膀胱镜检查步骤。
在优选实施方案中,所述器械提供取回绳从尿道受控露头,以使患者在家或由医疗专家通过简单的门诊(办公室)手术实施移除。在另一个实施方案中,所述器械包括漂浮的磁性取回绳,其可通过盲性手术磁力偶合到经由尿道插入的导管的末端以牵拉取回绳进入并通过尿道,以使所述取回绳可用于将器械从患者移除,而且可由医疗专家通过简单的门诊(办公室)手术实施移除而不需要膀胱镜检查。
所述泌尿器械可以实质上是针对在患者的泌尿道和泌尿系统中进行暂时性治疗或诊断使用而设计的任何器械。非限制性实例包括输尿管支架、药物递送器械或其组合。在优选实施方案中,所述泌尿器械是Cima等人的美国专利申请公开第2011/0152839号;TarisBiomedical,Inc等的PCT申请公开WO 2012/019155;Lee等人的美国专利申请公开第2012/0089122号、Taris Biomedical,Inc.等的PCT申请公开WO 2012/018923;Lee等人的美国专利申请公开第2010/0331770号;和Lee等人的美国专利申请公开第2011/0060309号中描述的器械之一,这些文献是以引用的方式并入本文。
所述取回绳可由任何合适材料制成,且可以包括天然或合成纤维。所述取回绳可具有单丝或复丝(例如,编织、纺织、绞合或类似)结构。优选是单丝绳,因为其表面光滑,所以可减少细菌生长。绳优选是弛缓的且具有相对薄的直径以尽可能减小患者不适,但具有足够高的拉伸强度以防在被牵拉以从患者撤回附接的医疗器械时断裂。在实施方案中,所述取回绳包括选自本领域中已知用于/用作不可吸收缝合线的那些材料。这种缝合线的这些制造材料的实例包括Nylon 6、聚丙烯、丝绸、棉、聚酯、聚酯/Dacron、316不锈钢和聚合物掺合物,如尤其是聚(偏氟乙烯)与聚(偏氟乙烯-共聚-六氟聚丙烯)的聚合物掺合物。所述取回绳可以经染色、透明或具有其天然颜色。所述取回绳可用本领域已知的抗微生物剂涂布和/或浸渍。所述取回绳可通过各种不同方式附接到所述泌尿器械,这些方式包括粘合、将绳子穿过或围绕器械的一部分捆绑或类似方式。
所述取回绳可以是单绳或回环。如本文所使用,关于取回绳的一部分的术语“末端部分”或“远端”可以是单股或回环。
本文公开的器械和方法可用于人类,不论男性或女性、成人或儿童或用于其它哺乳动物,如兽医或牲畜应用。因此,本文所使用的术语“患者”是指人类或其它哺乳动物。
可参照例示性且不加限制的图1至图15理解所述器械和方法。这些图并非按比例绘制。
在第一类实施方案(类型1)中,所述器械包括长取回绳,以使在将所述泌尿器械插入患者后,所述取回绳的末端部分处于伸出患者尿道的位置。视乎器械类型和泌尿器械在患者中的部署位置,取回绳的另一个末端部分可以附接到所述泌尿器械的各个位置。所述绳可以是单股或回环款式。
图1示出泌尿器械的一个实例,即可弹性变形药物递送器械10,其描述于Lee等人的美国专利申请公开第2012/0089122号中。所述取回绳的附接位置可变化,如在器械10的主体14的中间部分(如图1中的“A”所示)或在任一末端(如图1中的“B”和“C”所示)。其可缝合到器械10。在图2示出的一个实施方案中,所述取回绳通过在邻接药物蓄存内腔22的保留框架内腔20的内壁中的开口18附接到钢丝型件16(即,保留框架),所述药物蓄存内腔初始时可以容置药物负载(未示出)。所述取回绳12可以向或包裹钢丝型件16捆绑或打结。
在其它实施方案中,所述取回绳12被附接在器械10的末端部分之一(图1中的B和C)。在实施方案中,药物蓄存内腔22的末端之一或两个用端件封闭,所述端件可以是或可以包括被束缚在所述药物蓄存内腔的末端开口内的塞子。所述端件可以由实质上任何生物可相容材料制成。实例制作材料是硅酮,但可使用其它生物可相容聚合物和材料。
所述取回绳可以打结并穿过在泌尿器械的端件或其它部分中的孔成环。或者,所述取回绳可以装罐到泌尿器械的端件或其它部分中。图3A至图3D示出了四种可能实施方案,其中取回绳12被附接到端件30、端件31、端件32或端件33。图3A示出端件30,其具有贯穿端件的纵轴且供取回绳12从中穿线的单孔。图3B示出端件31,其具有平行于端件的纵轴且供取回绳12穿线的两个孔。图3C示出端件32,其中所述取回绳12的近端部分被包埋(例如,装罐),而远端部分伸出端件。在图3D中,绳的中间部分被包埋在端件33中,以使从端件33伸出两个取回绳12。图3E示出插入到药物递送器械外壳的大内腔的末端中的端件组件。
以上描述的类型1实施方案可以不是优选实施方案。即,虽然将取回绳置于尿道外可用于辅助非膀胱镜检查器械取回,但有可能带来不适、感染风险、器械不经意/过早撤回和喷尿或尿流方向的问题。为了克服这些缺点,提供如下文详述的其它类型的器械实施方案。
在第二类实施方案(类型2)中,取回绳(可以呈回环的形式)的末端部分自由但不伸出尿道。因此,取回绳的末端部分必须由医疗专家通过微创手术抓住,所述微创手术可以为盲性(不监视器械或取回绳)或借助膀胱镜可视化。在一个子类中,所述取回绳相比于类型1而言是短的。在膀胱镜检查取回手术期间当绳被抓住时,图4中的器械(例如)可按照直线方式被取回。按照直线方式取回可减小器械经过尿道时患者可能感到的不适。在第二子类中,取回绳具有磁性,且优选漂浮,且可在盲性手术中轻易抓住并撤回。
在第三类实施方案(类型3)中,取回绳的全部或一部分(如末端部分)缠绕、盘绕、囊封且/或按照其它方式限制在器械中或上(即,不自由且不从尿道伸出)直至要求取回器械。即,器械被设计以提供取回绳从尿道的受控露头。
图5示出类型3器械的一个实施方案。此处,泌尿器械主体54包括端件51,且取回绳52以限制形式,缠绕在棒形生物可腐蚀组件58周围。取回绳52的近端被附接到端件51,且取回绳的远端被附接到水力盖56。在器械部署在患者中后,生物可腐蚀组件58降解。一旦生物可腐蚀组件58在预定时间后失去连接水力盖56与泌尿器械主体54的充足完整性,取回绳52变为不受限制,例如,展开,如图5的下半图示所示。随后,水力盖56可被吸入患者的尿道中。一旦水力盖56被吸入尿道,排尿期间施加给盖56的水力将拖拽水力盖56和取回绳52的远端部分离开尿道,此时便可轻易抓住,从而允许患者或护理人员牵拉泌尿器械并将其从患者身体撤回。
如本文所描述,术语“生物可腐蚀”或“生物可降解”意指所述器械或其组件(例如,与释放取回绳缔合的生物可腐蚀组件)在体内通过溶解、酶水解、腐蚀、再吸收或其组合降解。在一个实施方案中,这种降解发生在不干扰将药物从器械释放的预期动力学的时间。例如,生物可腐蚀部分的大体腐蚀可以在药物制剂被大体或完全释放后才发生。
在优选实施方案中,水力盖56被制造成不漂浮(在生物可腐蚀组件已失效后),以使其在膀胱中下沉,从而促进其随着流入/流过的尿液吸入尿道。例如,水力盖可由生物可相容聚合物、金属或其组合形成,以使盖具有大于约1.0g/mL的密度。
水力盖56可具有实质上任何合适形状。在实施方案中,其最长维度小于5mm。所述形状可以是圆柱形、子弹形、球根形、椭圆形、圆形、碗形、球形、椭圆体形、新月形、半环形、豆形、香蕉形、甜甜圈形或矩形。设想其它形状。所述水力盖可由任何合适生物可相容材料制成。
所述水力盖为任选,并设想在无需水力盖下提供取回绳的受控露头的泌尿器械的变化例。例如,取回绳本身可充分地不漂浮且/或在远端部分成形以促进排尿吸入。
在另一个类型3器械的实施方案中,呈限制形式的取回绳包埋或容置在生物可腐蚀组件中。例如,如图7中所示,器械主体74包括带水力盖76的取回绳72,其包埋在生物可腐蚀组件78中,除了取回绳72的近端部分71,其用于将取回绳固定在泌尿器械主体74上。在器械部署于膀胱中的一段选择时间后,生物可腐蚀组件将降解并容许取回绳72和水力盖76呈现自由非限制形式,其随后可随着尿液穿过尿道以促进从患者撤回器械。
图8示出另一个类型3器械的实施方案。此处,器械主体84包括带水力盖86的取回绳82,其被限制于生物可腐蚀胶囊88中,除了取回绳82的近端部分81,其用于将取回绳固定在泌尿器械主体84上。在器械部署于膀胱中的一段选择时间后,生物可腐蚀胶囊将降解并破裂,从而容许取回绳82和水力盖86呈现自由非限制形式,其随后可随着尿液穿过尿道以促进从患者撤回器械。在一个实施方案中,在带有取回绳82的生物可腐蚀胶囊88中提供空气(或另一种生物可相容气体),其有利地可用于促进整个器械漂浮在膀胱中,直至生物可腐蚀胶囊82降解并破裂以释放绳子、水力盖和空气。
因为以上实施方案中的取回绳将可能在其限制位置(例如当缠绕或含于小空间中时)经受巨大张力,所以在优选实施方案中,所述取回绳是由薄丝绸或编织聚酯缝合线材料组成,而不是单丝尼龙或单丝聚丙烯缝合线材料。
图9示出类型3器械的又一实施方案。此处,器械主体94包括带水力盖96的取回绳92。取回绳的近端91被固定在器械主体(可以是药物递送器械)的末端。取回绳92的其余部分折叠并沿器械的长度用四个生物可腐蚀组件98约束。视乎例如器械主体和生物可腐蚀组件的特定形状和尺寸,可使用更少或更多生物可腐蚀组件。在器械部署于膀胱中的一段选择时间后,所述生物可腐蚀组件将降解,从而容许取回绳92和水力盖96呈现自由非限制形式,其随后可随着尿液穿过尿道以促进从患者撤回器械。在这个实施方案中,绳92可以处于相对低的张力下,并因此单丝缝合线材料可以是优选材料。生物可腐蚀组件98的数目和形状和放置方式可变化。水力盖为任选。
图9还以平面视图示出生物可腐蚀组件98可以是单内腔或多内腔类型。对于单内腔类型来说,器械主体和取回绳两者均可通过单内腔(C1)。对于多内腔类型来说,器械主体可穿过大内腔且取回绳可穿过大或小内腔。器械94可以在上半图示中示出,用于将泌尿器械保持在膀胱中的保留形状与用于将泌尿器械部署穿过患者尿道的低形态形状之间弹性变形。图9的下半图示示出了在部署导管或膀胱镜中的这种低形态形状。
限制所述取回绳时的构造可赋予在生物可腐蚀组件降解后供部署取回绳使用的可靠性、时机和便利。例如,绳应能够轻易松开而不与自身或泌尿器械纠缠。图6A示出类型3器械的又一个实施方案。此处,取回绳62螺旋缠绕并被限制于生物可腐蚀盖68内。取回绳的末端A被附接到泌尿器械64,而取回绳的末端B自由。一旦生物可腐蚀盖在尿液中溶解或降解,那么取回绳62将松开。
在另一个实施方案中,生物可腐蚀组件可呈现生物可降解且暂时粘稠材料的形式,其可用于取回绳形成为限制结构的过程中。例如,可使用粘性多糖水溶液以促进如图6B中所示的绳盘绕过程。此处,将粘稠材料69施用到取回绳62线圈的有限区域,如图6B中所示。或者,可在将绳折叠或盘绕成限制形式之前或之后沿着整个或大体上整个绳子施用所述材料。视乎材料和厚度,所述绳子局部或整体上趋向笔直。粘稠材料在绳盘绕过程期间保持粘稠且在盘绕过程后可变干或凝固。
在另一个类型2器械的实施方案中,所述取回绳是或包括磁性或铁磁性漂浮绳。通过使绳子漂浮于尿液中,可减少或避免绳子停置于膀胱底部,否则将可能在排尿期间被水力拖出,这可进一步触发患者不适、感染、器械可能锚固在膀胱颈,因长期与膀胱壁接触,所以可导致炎症。在一个实施方案中,取回绳,且有利地仅取回绳磁力耦合到尖端含磁体的导管。一旦绳子露出,患者或护理人员便可将其抓住以将器械完全拉出病患。
注意经由尿道拉出绳子所需的磁力远低于直接拉出器械所需的磁力。因此,获得取出时所要求的磁力所需的铁磁性元件的大小也较小。这使得铁磁性元件的大小减小的同时仍与磁体保持足以取出绳子的磁性吸力。
此外,在优选实施方案中,与取回绳缔合的磁性组件遍布于取回绳的大部分,而不仅仅在其末端,相比于取回绳的尖端或泌尿器械之一带磁性的盲性手术,这有利地增加了在盲性手术中绳子磁力耦合到尖端含磁体的导管的可能性和便利性(因为铁磁性元件/绳子将散步在整个膀胱的更多位置)。
图10示出在一个实施方案中取回过程如何工作的一系列图示。在第一(顶部)图示中,泌尿器械(如药物递送器械)坐落于膀胱的底部,同时漂浮取回绳向膀胱的顶部浮动,离开靠近膀胱颈的区域,在膀胱颈,有可能经由尿道被拖出。在第二图示中,将尖端含磁体的导管经由尿道插入膀胱,且磁体磁力耦合到含有铁磁性材料的取回绳。随后,从膀胱撤回尖端含磁体的导管和耦合取回绳的一部分。最后,将绳子经由尿道外置并牵拉以经由尿道从膀胱取回器械。
图11示出取回绳结构的两种类型。在图的顶部,绳子是空心的。即,形状为环形,内腔可装载尺寸经调整以适配在内腔中的一个或优选多个铁磁性元件(未示出)。在图的底部,绳子是实心的。其不具有内腔。在这种实施方案中,可将铁磁性元件分散在形成绳子的材料中。例如,绳子可由合成聚合物形成,所述聚合物被熔化且随后挤压成一个或多个细丝。在挤压前,可将铁磁性材料混合/分散到熔化物中。
图12示出具有铁磁性元件的绳子的多种潜在构造。针对实现方式选择的构造可视乎实际上需要多大的力将绳子拉出尿道,和什么构造符合这个要求而定。铁磁性元件不一定沿着绳子的整个长度放置。例如,如果希望确保绳子的特定部分附接到磁体,那么铁磁性元件可仅仅在绳子的一部分中。
本文描述的取回绳或磁性漂浮取回绳系统的受控露头可与部署在或穿过患者膀胱的实质上任何类型的固定或自由浮动医疗器械配合使用。特定非限制性实例包括输尿管支架和膀胱内药物递送器械,如未拴系或自由浮动药物递送器械。在另一个实施方案中,所述泌尿器械可以是诊断或成像器械,如Neeman等人的美国专利第2010/0076261号中公开的器械。在一个实施方案中,所述磁性漂浮取回绳被构造成受控露头。
将取回绳附接到泌尿器械的位置可影响移除力。例如,对于膀胱内药物递送器械的实施方案,如果将绳子附接在中间部分(如图14)或至少所述器械可“桥”跨内尿道口的位置,那么相比于将绳子附接到器械末端或器械不桥跨尿道口(如图15)的情况,将要求更大的力(扣住器械)以将器械引导到尿道。在绳子贯穿整个治疗期期间从尿道露出以防止器械偶然拉出的情况中优选图14的实施方案。
以上描述的取回绳系统可与各种不同的可植入泌尿器械配合使用。下文提供这种器械的实施方案的进一步描述。
在一个实施方案中,所述泌尿器械是针对经由尿道插入并自由浮动地保留在膀胱中而设计的药物递送器械。在一个实施方案中,所述器械包括药物蓄存部分、保留框架部分和取回绳部分。所述器械具有适合保留在膀胱中的相对膨胀形状,但可弹性压缩以呈现相对较低形态形状用于部署穿过部署仪器(如膀胱镜或导管)的通道。在部署到膀胱中(即释放到膀胱中)后,所述器械可以呈现相对膨胀形状以保持所述药物递送器械。
在另一个实施方案中,所述泌尿器械是输尿管支架器械,其包括在支架的膀胱停靠末端处或附近的取回绳部分。在一个实施方案中,所述输尿管支架器械还包括与所述输尿管支架部分,如与支架末端之一缔合的至少一个药物递送部分。在特定实施方案中,所述药物递送部分被定位在膀胱停靠末端上以将药物局部递送到膀胱,但肾脏停靠末端还可以与药物递送部分缔合,或两个末端可以与不同药物递送组件缔合,不论支架末端是笔直还是卷曲。在一些实施方案中,药物递送部分还可以沿着输尿管支架部分的整个或部分中心主体延伸。
就本发明的目的而言,诸如“相对膨胀形状”、“相对较高形态形状”或“保留形状”的术语基本上表示适合将器械保持在预期植入位置的任何形状,包括但不限制于适合将器械保持在膀胱中的盘绕或卷饼形状。类似地,诸如“相对较低形态形状”、“低形态形状”或“部署形状”的术语基本上表示适合将药物递送器械部署到身体中的任何形状,包括适合将器械部署穿过导管、膀胱镜或定位在身体内腔(如尿道)中的其它部署仪器的工作通道的直线或细长形状。在实施方案中,所述药物递送器械可以天然呈现相对膨胀形状且可以通过人工方式或借助外部设备变形为供插入身体使用的相对较低形态形状。一旦部署,所述器械可以自发或自然恢复用于保留在身体中的初始相对膨胀形状。
在一个实施方案中,所述药物递送器械包括界定药物蓄存内腔的管或壁和界定保留框架内腔的管或壁。药物蓄存内腔中含有药物制剂,其可以包括包含一种或多种药物的一个或多个固体药物单元(例如,片剂或胶囊)。端塞可以封闭药物蓄存内腔和/或保留框架内腔的末端。在一个实施方案中,取回绳可以与器械的一个或两个末端操作缔合。在另一个实施方案中,取回绳可以与保留框架本身或与界定药物蓄存内腔和/或保留框架内腔的管操作缔合。
保留框架内腔可以装载保留框架(有时称为“钢丝型件”),其可以是弹性线。在一种情况中,所述保留框架包括镍钛诺线。保留框架可以被构造以自发恢复保留形状,如图示的“卷饼”形状或另一种盘绕形状。例如,保留框架可以具有弹性极限和模量,其允许器械以相对较低形态形状导入身体、容许器械在身体内之后恢复相对膨胀形状,且阻碍器械响应预期力(如与逼尿肌收缩和排尿有关的水力)在体内呈现相对较低形态形状。因此,一旦植入,器械可以保持在身体中,从而限制或防止意外驱逐。
用于形成药物递送器械主体的材料可以具有弹性或挠性以容许器械在部署形状与保留形状之间移动。用于形成器械主体的材料还可以透水或多孔,以使增溶流体可进入药物蓄存部分,从而在植入器械后溶解药物单元。例如,可以使用硅酮或另一种生物可相容弹性体材料。
在将药物递送器械设计成植入膀胱的一个实施方案中,药物递送器械被设计以通过膀胱镜检查方式经由尿道插入膀胱。因此,器械可以经过大小调整并成形以适配穿过部署仪器(如导管或膀胱镜)的窄管形路径。一般来说,成人用膀胱镜具有约5至7mm的外径和工作通道,其具有约2.4mm至约2.6mm的内径。在其它实施方案中,膀胱镜具有具更大内径,如4mm或更大的内径的工作通道。因此,器械可以相对小。例如,当器械弹性变形为相对较低形态形状时,成年患者用器械可以具有约3.75mm或更小,如约2.6mm或更小的总外径。对于幼儿患者,预期器械的尺寸更小。
膀胱内器械的整体形状可以允许器械在膀胱内自行调整以减少其与膀胱壁的啮合或接触。所述器械的保留形状还可以足够小以容许在膀胱内移动。特定来说,当部署时,器械可以足够小以在膀胱内移动,如在膀胱充盈的大部分条件下在整个膀胱内自由移动或畅通,从而促进患者对器械的耐受。器械的自由移动还促进在整个膀胱内均匀药物递送,而不是只在释放孔附近的特定膀胱位置。然而,虽然当膀胱排空时,在非排空下可以在膀胱内自由移动的器械不再自由移动,但如果充分可压缩,那么器械仍是可耐受的。
在一些实施方案中,所述器械至少部分为非生物可腐蚀。合适的制造材料可以包括医学级硅酮、天然乳胶、聚四氟乙烯(PTFE)、膨胀PTFE、聚(乳酸-共聚-乙醇酸)(PLGA)、聚(癸二酸甘油酯)(PGS)、不锈钢、镍钛诺、埃尔吉洛伊非磁性合金(elgiloy)(非铁磁性金属合金)、聚丙烯、聚乙烯、聚碳酸酯、聚酯、尼龙或其组合。在释放药物制剂后,器械和/或保留框架可以大体上完整地或分多个工件移除。在一些实施方案中,所述器械部分生物可腐蚀,以使在部分腐蚀后,器械断裂成足够小的不可腐蚀工件从膀胱排泄。本领域已知可用的生物可相容可腐蚀和不可腐蚀制造材料。
基本上,药物递送器械包括至少一个药物蓄存部分。在实施方案中,药物蓄存部分包括形成至少一个药物蓄存内腔的器械主体部分,所述内腔容置至少一种药物的药物制剂。所述药物蓄存部分可以侧壁为边界。药物蓄存内腔可以包括弹性管,如聚合物管。在一个实施方案中,器械的药物蓄存内腔包括长形管。管的内部可以界定一个或多个药物蓄存室,且药物制剂可以容置于药物蓄存室中。在其它实施方案中,药物蓄存内腔采取非管的形式。
药物蓄存部分可以作为渗透泵操作。在这一实施方案中,管可以由透水材料(如硅酮)形成,或管可以具有多孔结构,或二者兼具。在植入后,水或尿液渗透穿过管壁、穿过管形成的一个或多个孔、或穿过多孔管形成的一个或多个通孔。水进入蓄存室,并被药物制剂吸收。溶解的药物在受控速率下经由一个或多个孔分散离开蓄存室,被蓄存室中的渗透压驱动。渗透泵的递送速率和整体性能受器械参数影响,如管的表面积;用于形成管的材料的液体渗透性;孔的形状、大小、数目和放置;和药物制剂溶解特性等各个参数。根据熟知原理,可从界定特定药物递送系统的理化参数预测递送速率。在一些实施方案中,器械可以初始展现零阶释放速率且随后可以展现降低的非零阶释放速率,在这种情况中,整体药物释放特性可以从初始零阶释放速率和总负载确定。
在替代实施方案中,所述器械可以实质上按照以下方式操作:使药物从管扩散穿过(i)形成于管壁中的一个或多个离散孔,或形成于多孔管壁中的通孔,或(ii)本身可渗透药物的管壁或(iii)布置于管的一个或两个末端中的端件或壁,或(iv)其组合。在扩散穿过壁的实施方案中,可以不包括孔或通孔。在另外其它实施方案中,所述器械可以按照渗透与扩散组合的方式操作。
药物蓄存部分可以由弹性体材料形成,所述材料可以容许器械弹性变形以供其插入患者,例如,在其部署穿过部署仪器(如膀胱镜或导管)期间。例如,所述管可以连同保留框架弹性变形以用于膀胱内植入。在实施方案中,药物蓄存部分是由呈弹性体性且透水的材料形成。呈弹性体性且透水的一种材料是硅酮,但可使用其它生物可相容材料。
器械主体或其组件可由不可再吸收材料形成。例如,其可由医学级硅酮管形成。合适的不可再吸收材料的其它实例包括合成聚合物,其选自聚(醚)、聚(丙烯酸酯)、聚(甲基丙烯酸酯)、聚(乙烯吡咯烷酮)、聚(乙酸乙烯酯)、聚(尿烷)、纤维素、乙酸纤维素、聚(硅氧烷)、聚(乙烯)、PTFE和其它氟化聚合物、聚(硅氧烷)、其共聚物和其组合。
所述器械主体或其组件可以是生物可腐蚀的。希望包括甚至具有完全生物可腐蚀器械的取回绳,例如,如果患者因器械或药物而经受非预期副作用,那么可以希望在治疗期结束前移除器械。在实施方案中,器械主体、用于限制取回绳的生物可腐蚀组件或两者可以由生物可降解或生物可再吸收聚合物制成。合适的这种材料的实例包括合成聚合物,其选自聚(酰胺)、聚(酯)、聚(酯酰胺)、聚(酐)、聚(原酸酯)、聚磷腈、拟聚(氨基酸)、PGS、其共聚物和其混合物。在一个优选实施方案中,可再吸收合成聚合物选自聚(乳酸)、聚(乙醇酸)、PLGA、聚(己内酯)和其混合物。其它可固化的生物可再吸收弹性体包括聚(己内酯)(PC)衍生物、氨基醇基聚(酯酰胺)(PEA)和聚(柠檬酸辛二醇酯)(POC)。
所述器械主体还可被构造以维持所述保留形状,而无需或至少无需保留框架。例如,器械主体可以包括使器械保持其保留形状的“骨架”。所述“骨架”可以是形成药物蓄存部分的材料的较厚且/或较坚固区段。“骨架”可以直线、螺旋或弯曲地贯穿药物蓄存部分的长度。在特定实施方案中,器械主体是用经处理或更改以使器械可在保留形状与部署形状之间变形的材料形成。例如,用于形成药物蓄存部分的材料可以在向器械施加热时,如当进入膀胱后暴露于体温时“记忆”并自发呈现相对膨胀形状。在一些情况中,加热可以导致聚合物材料的至少一部分交联,以使器械能够在部署于膀胱中后保持保留形状。
在一些实施方案中,药物递送器械包括(尤其)用于如通过渗透、扩散或其组合分散药物的一个或多个孔或孔口。所述孔可以沿着管隔开以提供用于释放药物制剂的通路。孔或孔口可以定位成穿过管的侧壁或末端。
药物制剂可以包括实质上任何治疗、预防或诊断剂,如可用于在/向膀胱或输尿管局部释放以进行局部或区域性治疗的作用剂。药物制剂可以只由药物组成,或可以包括一种或多种药物可接受赋形剂。所述药物可以是生物制剂。所述药物可以是代谢物。如本文所使用,关于本文描述的任何具体药物的术语“药物”包括其替代形式,如盐形式、游离酸形式、游离碱形式、溶剂化物和水合物。药物可接受赋形剂为本领域已知且可以包括润滑剂、粘度改性剂、表面活性剂、渗透剂、稀释剂和预期促进药物的操作、稳定性、分散性、润湿性和/或释放动力学的任何其它非活性配方成分。
药物递送器械可以用于治疗疼痛。可使用各种不同的麻醉剂、止痛剂和其组合。麻醉剂可以是可卡因类似物。在特定实施方案中,麻醉剂是氨基酰胺、氨基酯或其组合。氨基酰胺或酰胺类麻醉剂的典型实例包括阿替卡因(articaine)、布比卡因(bupivacaine)、卡替卡因(carticaine)、辛可卡因(cinchocaine)、依替卡因(etidocaine)、左布比卡因(levobupivacaine)、利多卡因(lidocaine)、卡波卡因(mepivacaine)、丙胺卡因(prilocaine)、罗哌卡因(ropivacaine)和三甲卡因(trimecaine)。氨基酯或酯类麻醉剂的典型实例包括阿米卡因(amylocaine)、苯佐卡因(benzocaine)、布大卡因(butacaine)、氯普鲁卡因(chloroprocaine)、可卡因(cocaine)、环美卡因(cyclomethycaine)、二甲卡因(dimethocaine)、海克卡因(hexylcaine)、拉罗卡因(larocaine)、美普卡因(meprylcaine)、美布卡因(metabutoxycaine)、俄妥卡因(orthocaine)、哌罗卡因(piperocaine)、普鲁卡因(procaine)、丙对卡因(proparacaine)、丙氧卡因(propoxycaine)、丙美卡因(proxymetacaine)、利索卡因(risocaine)和丁卡因(tetracaine)。这些麻醉剂通常是弱碱且可以调配成盐(如盐酸盐),以使其为水溶性,但还可以使用呈游离碱或水合物形式的麻醉剂。还可以使用其它麻醉剂,如隆多卡因(lontocaine)。所述药物还可以是展现麻醉作用的抗毒蕈碱化合物,如奥昔布宁(oxybutynin)或丙哌维林(propiverine)。所述药物还可以包括单独或与麻醉剂组合的本文描述的其它药物。
止痛剂可以是类鸦片。类鸦片激动剂的典型实例包括阿芬太尼(alfentanil)、烯丙罗定(allylprodine)、阿法罗定(alphaprodine)、阿尼利定(anileridine)、苄吗啡(benzylmorphine)、贝齐米特(bezitramide)、丁丙诺菲(buprenorphine)、布托啡诺(butorphanol)、氯尼他秦(clonitazene)、可待因(codeine)、二氢去氧吗啡(desomorphine)、右吗拉胺(dextromoramide)、地佐辛(dezocine)、地恩丙胺(diampromide)、二醋吗啡酮(diamorphone)、二氢可待因(dihydrocodeine)、二氢吗啡(dihydromorphine)、地美沙朵(dimenoxadol)、地美庚醇(dimepheptanol)、二甲噻丁(dimethylthiambutene)、吗苯丁酯(dioxaphetyl butyrate)、地匹哌酮(dipipanone)、依他佐辛(eptazocine)、依索庚嗪(ethoheptazine)、乙甲噻丁(ethylmethylthiambutene)、乙基吗啡(ethylmorphine)、依托尼秦(etonitazene)、芬太尼(fentanyl)、海洛因(heroin)、氢可酮(hydrocodone)、氢化吗啡酮(hydromorphone)、羟哌替啶(hydroxypethidine)、异美沙酮(isomethadone)、凯托米酮(ketobemidone)、羟甲左吗喃(levorphanol)、左芬啡烷(levophenacylmorphan)、罗芬太尼(lofentanil)、配西汀(meperidine)、美普他酚(meptazinol)、美他佐辛(metazocine)、美沙酮(methadone)、美托酮(metopon)、吗啡(morphine)、麦罗啡(myrophine)、纳布啡(nalbuphine)、罂粟碱(narceine)、尼可吗啡(nicomorphine)、去甲左啡诺(norlevorphanol)、去甲美沙酮(normethadone)、纳洛芬(nalorphine)、去甲吗啡(normorphine)、诺匹哌酮(norpipanone)、鸦片(opium)、羟考酮(oxycodone)、羟吗啡酮(oxymorphone)、阿片全碱(papaveretum)、喷他佐辛(pentazocine)、非那多松(phenadoxone)、非诺吗烷(phenomorphan)、非那唑辛(phenazocine)、苯哌利定(phenoperidine)、匹米诺定(piminodine)、哌腈米特(piritramide)、普罗庚嗪(proheptazine)、普罗麦多(promedol)、丙哌利定(properidine)、丙吡胺(propiram)、丙氧酚(propoxyphene)、舒芬太尼(sufentanil)、替利定(tilidine)、曲马多(tramadol)、其药物可接受盐和其混合物。考虑了其它类鸦片药物,如μ、κ、δ和伤害感受类鸦片受体激动剂。
止痛剂可以是麻醉性或非麻醉性作用剂。止痛剂的典型实例包括对乙酰氨基酚、丁丙诺菲(buprenorphine)、布托啡诺(butorphanol)、可待因、二氢可待因、芬太尼、海洛因、氢可酮、氢化吗啡酮、美沙酮、吗啡、尼可吗啡、羟考酮、羟吗啡酮、喷他佐辛、哌替啶、丙氧芬(propoxyphene)、马洛芬(pyridium)(非那吡啶(phenazopyridine))、蒂巴因(thebaine)、曲马多、水杨醇、非那吡啶盐酸盐、乙酰水杨酸、氟苯柳(flufenisal)、布洛芬(ibuprofen)、吲哚洛芬(indoprofen)、吲哚美辛(indomethacin)和萘普生(naproxen)。止痛剂可以选自(例如)非类鸦片、非甾体止痛剂、类鸦片止痛剂和水杨酸酯等类型。
药物递送器械可以用于治疗炎症性疾病,如IC/BPS(间质性膀胱炎/膀胱疼痛综合症),以及放射性膀胱炎、前列腺炎、尿道炎、手术后疼痛和肾结石。用于这些疾病的具体药物的非限制实例包括利多卡因(lidocaine)、粘多糖(例如,硫酸软骨素、舒洛地特(sulodexide))、戊聚糖多硫酸钠(PPS)、二甲亚砜(DMSO)、奥昔布宁(oxybutynin)、丝裂霉素C、肝素、黄酮哌酯、酮咯酸或其组合。对于肾结石,药物可以经过选择以治疗疼痛且/或促进肾结石溶解。可以用于治疗IC/BPS的药物的其它实例包括神经生长因子单克隆抗体(MAB)拮抗剂,如他尼珠单抗(Tanezumab);和钙通道α-2-δ调节剂,如PD-299685或加巴喷丁(gabepentin)。
所述药物递送器械可以与放置输尿管支架联合使用,(例如)以治疗由输尿管支架放置所导致的疼痛、尿急或尿频。用于这些治疗的具体药物的非限制实例尤其包括抗毒蕈碱药物、α-阻断剂、麻醉剂和非那吡啶。
所述药物递送器械可以用于治疗尿失禁、尿频或尿急,包括急迫性尿失禁和神经性尿失禁,以及膀胱三角炎。可使用的药物包括抗胆碱能剂、止痉挛剂、抗毒蕈碱剂、β-2激动剂、α-肾上腺素能药物、抗痉挛药、去甲肾上腺素摄取抑制剂、血清素摄取抑制剂、钙通道阻断剂、钾通道开放剂和肌肉松弛剂。用于治疗尿失禁的合适药物的典型实例包括奥昔布宁、S-奥昔布宁、依米波宁(emepronium)、维拉帕米(verapamil)、丙咪嗪(imipramine)、黄酮哌酯(flavoxate)、阿托品(atropine)、普鲁本辛(propantheline)、托特罗定(tolterodine)、罗西维林(rociverine)、克伦特罗(clenbuterol)、达非那新(darifenacin)、特罗地林(terodiline)、曲司氯铵(trospium)、莨菪碱(hyoscyamin)、丙哌维林(propiverine)、去氨加压素(desmopressin)、伐米胺(vamicamide)、克利溴铵(clidinium bromide)、双环胺HCl、格隆溴铵(glycopyrrolate)氨基醇酯、异丙托溴铵(ipratropium bromide)、溴美喷酯(mepenzolate bromide)、溴化甲基东莨菪碱(methscopolamine bromide)、氢溴酸东莨菪碱(scopolamine hydrobromide)、噻托溴铵(iotropium bromide)、富马酸非索罗定(fesoterodine fumarate)、YM-46303(YamanouchiCo.,Japan)、兰吡立松(lanperisone)(Nippon Kayaku Co.,Japan)、依普利松(inaperisone)、NS-21(Nippon Shinyaku Orion,Formenti,Japan/Italy)、NC-1800(Nippon Chemiphar Co.,Japan)、Z D-6169(Zeneca Co.,United Kingdom)和司洛碘铵(stilonium iodide)。
所述药物递送器械可以用于治疗尿道癌,如膀胱癌和前列腺癌。可使用的药物包括抗增生剂、细胞毒素剂、化学治疗剂或其组合。适合治疗尿道癌的药物的典型实例包括卡介菌(BCG)疫苗、顺铂、多柔比星(doxorubicin)、戊柔比星(valrubicin)、吉西他滨(gemcitabine)、分支杆菌细胞壁-DNA复合体(MCC)、甲氨蝶呤、长春花碱(vinblastine)、塞替派(thiotepa)、丝裂霉素、氟尿嘧啶(fluorouracil)、亮丙瑞林(leuprolide)、己烯雌酚(diethylstilbestrol)、雌氮芥(estramustine)、醋酸甲地孕酮(megestrol acetate)、环丙孕酮(cyproterone)、氯他米特(flutamide)、选择性雌激素受体调节剂(即SERM,如三苯氧胺(tamoxifen))、肉毒素和环磷酰胺(cyclophosphamide)。所述药物可以是生物制剂,且可以包括单克隆抗体、TNF抑制剂、抗白细胞介素或类似制剂。所述药物还可以是免疫调节剂,如TLR激动剂,包括咪喹莫特(imiquimod)或另一种TLR7激动剂。所述药物还可以是激酶抑制剂,如纤维母细胞生长因子受体-3(FGFR3)-选择性酪氨酸激酶抑制剂、磷脂酰肌醇3激酶(PI3K)抑制剂或丝裂原活化蛋白激酶(MAPK)抑制剂等或其组合。其它实例包括塞来昔布(celecoxib)、厄洛替尼(erolotinib)、吉非替尼(gefitinib)、紫杉醇(paclitaxel)、多酚E、戊柔比星、新抑癌蛋白(neocarzinostatin)、阿帕齐醌(apaziquone)、贝利司他(Belinostat)、巨大戟醇甲基丁烯酸酯、凋亡促进剂(Urocidin)(MCC)、普罗昔铵(Proxinium)(VB 4845)、BC 819(BioCancell Therapeutics)、钥孔戚血蓝蛋白、LOR 2040(Lorus Therapeutics)、尿刊酸、OGX 427(OncoGenex)和SCH 721015(Schering-Plough)。其它膀胱内癌症治疗包括:小分子,如阿帕喹酮(Apaziquone)、阿霉素(adriamycin)、AD-32、多柔比星(doxorubicin)、多西紫杉醇(doxetaxel)、表柔比星(epirubicin)、吉西他滨、HTI-286(哈米特林(hemiasterlin)类似物)、伊达比星(idarubicin)、γ-亚麻酸、米托蒽醌(mitozantrone)、葡甲胺(meglumine)和塞替派(thiotepa);大分子,如活化巨噬细胞、活化T细胞、EGF-葡萄聚糖、HPC-多柔比星(HPC-doxorubicin)、IL-12、IFN-a2b、IFN-γ、α-乳白蛋白、p53腺病毒载体、TNFα;组合,如表柔比星+BCG、IFN+表柔比星(farmarubicin)、多柔比星(Doxorubicin)+5-FU(经口)、BCG+IFN和百日咳毒素+膀胱切除术;活化细胞,如巨噬细胞和T细胞;膀胱内输注,如IL-2和多柔比星(Doxorubicin);化疗增敏剂,如BCG+抗纤维蛋白溶解剂(对甲基苯甲酸或氨基己酸)和多柔比星(Doxorubicin)+维拉帕米(verapimil);诊断剂/显像剂,如己基氨基酮戊酸、5-氨基酮戊酸、碘脱氧尿嘧啶核苷、HMFG1 Mab+Tc99m;和局部毒性管理作用剂,如福尔马林(Formaline)(出血性膀胱炎)。
所述药物递送器械可以用于治疗涉及膀胱、前列腺和尿道的感染。可以施予抗生素、抗菌剂、抗真菌剂、抗原生动物药、防腐剂、抗病毒剂和其它抗感染剂来治疗这些感染。用于治疗感染的药物的典型实例包括丝裂霉素、环丙沙星(ciprofloxacin)、诺氟沙星(norfloxacin)、氧氟沙星(ofloxacin)、甲胺、呋喃咀啶(nitrofurantoin)、氨苄青霉素(ampicillin)、阿莫西林(amoxicillin)、萘夫西林(nafcillin)、甲氧苄啶(trimethoprim)、磺胺类药甲氧苄啶-磺胺甲唑(trimethoprimsulfamethoxazole)、红霉素(erythromycin)、多西环素(doxycycline)、甲硝唑(metronidazole)、四环素(tetracycline)、卡那霉素(kanamycin)、青霉素(penicillins)、头孢菌素(cephalosporins)和氨基糖苷类。
所述药物递送器械可以用于治疗泌尿生殖部位(如膀胱或子宫)纤维化。用于治疗纤维化的药物的典型实例包括己酮可可碱(pentoxphylline)(黄嘌呤类似物)、抗TNF、抗TGF剂、GnRH类似物、外源性孕酮、孕酮拮抗剂、选择性雌激素受体调节剂、达那唑(danazol)和NSAID。
所述药物递送器械可以用于治疗神经性膀胱功能障碍。用于治疗神经性膀胱功能障碍的药物的典型实例包括止痛剂或麻醉剂,如利多卡因(lidocaine)、布比卡因(bupivacaine)、卡波卡因(mepivacaine)、丙胺卡因(prilocaine)、阿替卡因(articaine)和罗哌卡因(ropivacaine);抗胆碱能类;抗毒蕈碱类,如奥昔布宁(oxybutynin)或丙哌维林(propiverine);香草酸(vanilloid),如辣椒素(capsaicin)或树脂毒素(resiniferatoxin);抗毒蕈碱类,如作用于M3毒蕈碱样乙酰胆碱受体(mAChR)的抗毒蕈碱类;止痉挛药,包括GABAB激动剂,如巴氯芬(baclofen);肉毒素;辣椒素;α-肾上腺素能拮抗剂;抗痉挛药;血清素再摄取抑制剂,如阿米替林(amitriptyline);和神经生长因子拮抗剂。在各个实施方案中,所述药物可以是作用于膀胱传入神经的药物或作用于传出神经胆碱能传递的药物,如Reitz等人,Spinal Cord 42:267-72(2004)中所描述。
所述药物可以选自已知用于治疗由神经性逼尿肌过度活动和/或低顺应性逼尿肌引起的尿失禁的那些药物。这些药物类型的实例包括膀胱松弛药(例如奥昔布宁(oxybutynin)(具有显著肌肉松弛活性和局部麻醉活性的抗毒蕈碱剂)、丙哌维林(propiverine)、impratroprium、噻托溴铵(tiotropium)、曲司氯铵(trospium)、特洛地林(terodiline)、托特罗定(tolterodine)、普鲁本辛(propantheline)、羟苄利明(oxyphencyclimine)、黄酮哌酯(flavoxate)和三环抗抑郁药;用于阻断支配膀胱和尿道的神经的药物(例如,香草酸类(辣椒素(capsaicin)、树脂毒素(resiniferatoxin))、肉毒菌A毒素);或调节逼尿肌收缩力、排尿反射、逼尿肌括约肌协同失调的药物(例如,GABAb激动剂(巴氯芬(baclofen)、苯二氮卓类)。在另一个实施方案中,所述药物选自已知用于治疗由神经性括约肌损伤引起的尿失禁的那些药物。这些药物的实例包括α肾上腺素能激动剂、雌激素、β-肾上腺素能激动剂、三环抗抑郁药(丙咪嗪(imipramine)、阿米替林(amitriptyline))。在还有另一个实施方案中,所述药物选自已知用于促进膀胱排空的那些药物(例如,α肾上腺素能拮抗剂(酚妥拉明(phentolamine))或胆碱能药物)。在又一个实施方案中,所述药物选自抗胆碱能药物(例如双环胺(dicyclomine))、钙通道阻断剂(例如异搏定(verapamil))、托品烷生物碱(例如阿托品(atropine)、莨菪碱(scopolamine))、痛敏肽(nociceptin)/孤啡肽(orphanin FQ)和乌拉胆碱(bethanechol)(例如,m3毒蕈硷激动剂、胆碱酯)。
在一个实施方案中,所述药物制剂呈固体或半固体形式,例如以减小药物制剂的总体积并从而减小器械的大小且/或在储存期间和释放前使药物维持稳定形式。所述半固体形式可以是(例如)乳液或悬浮液;凝胶或膏糊。所述固体形式可以是装载到药物蓄存室(例如,容置内腔)中的固体药物单元。所述药物单元是固体离散物件,其大体上保持选择性赋予的形状(在所述递送器械于组装、储存和植入前的操作期间一般将暴露的温度和压力条件下)。药物单元可以呈片剂、胶囊、丸剂或珠粒的形式,但也可以采用其它构造。
本发明将通过以下非限制性实例加以说明。
实例1
将ETHIBOND EXCELTM(Ethicon Endo-Surgery Inc.)聚酯缝合线(5-0号,绿色编织型)用作取回绳。将安慰剂药物递送器械(具有卷饼形保留框架的硅酮管)用作典型泌尿器械。将取回绳的一端附接到器械的末端。随后,螺旋缠绕或盘绕绳子并收紧以使其可以限制于平面内(图13A和图13B)。随后,在绑绳上放置生物可降解盖。具体来说,使用如图13A和图13B所示的明胶胶囊盖(4号),但可以使用其它可降解聚合物,如PLGA。
将由漏斗(16oz容量)和乳胶管(ID:6.35mm和长度:23cm)组成的简单排泄模型用作测试设备。将具有加盖/受限制的取回绳的药物递送器械放置在漏斗部分内并填充水,同时夹住乳胶管的一端。当漏斗排空时松开管以使漏斗只借助重力排空。当明胶盖溶解时,在水中展开成束绳子。在重复填充和排空步骤几次后,取回绳在管的末端露头。因此,这个实验证实了取回绳的受控露头。
本文引用的公开和其中所引述的材料具体以引用的方式并入本文。本领域技术人员将从以上详细描述明白本文描述的方法和器械的修改和变化。预期这些修改和变化属于随附权利要求的范围内。
Claims (15)
1.一种医疗器械,其包括:
泌尿器械;和
附接到所述泌尿器械的取回绳,所述取回绳包括主体,所述主体具有连接到所述泌尿器械的近端和相对的远端,
其中所述取回绳包括至少沿所述取回绳的所述主体的长度的铁磁性材料,以容许磁力地操纵所述取回绳穿过尿道,从而允许取出所述医疗器械。
2.根据权利要求1所述的医疗器械,其中所述取回绳的所述主体是空心的且所述铁磁性材料含于所述取回绳的内腔中。
3.根据权利要求1所述的医疗器械,其中所述取回绳的所述主体是实心的且所述铁磁性材料包埋于所述取回绳的所述主体中。
4.根据权利要求1所述的医疗器械,其中所述铁磁性材料被布置在所述取回绳的所述主体的外表面上。
5.根据权利要求1至权利要求4中任一项所述的医疗器械,其中所述取回绳漂浮于尿液中。
6.根据权利要求1至权利要求4中任一项所述的医疗器械,其中所述泌尿器械包括膀胱内药物递送器械。
7.根据权利要求6所述的医疗器械,其中所述取回绳漂浮于尿液中。
8.根据权利要求1至权利要求4中任一项所述的医疗器械,其中所述泌尿器械包括输尿管支架。
9.根据权利要求8所述的医疗器械,其中所述取回绳漂浮于尿液中。
10.根据权利要求1至权利要求4中任一项所述的医疗器械,其中所述泌尿器械包括(i)具有至少一个药物蓄存内腔的器械主体,和(ii)定位在所述至少一个药物蓄存内腔中的药物制剂,其中所述泌尿器械可在用于将所述泌尿器械保持在膀胱中的保留形状与用于将所述泌尿器械部署穿过患者尿道的低形态形状之间弹性变形。
11.根据权利要求10所述的医疗器械,其中所述取回绳漂浮于尿液中。
12.根据权利要求2或权利要求3中任一项所述的医疗器械,其中所述铁磁性材料包括球粒、圆柱体、编织物或包埋芯中的一种或多种。
13.根据权利要求3所述的医疗器械,其中所述铁磁性材料分散在形成所述取回绳的所述主体的材料中。
14.根据权利要求1所述的医疗器械,其中所述铁磁性材料遍布于所述取回绳的大部分。
15.根据权利要求2或权利要求3中任一项所述的医疗器械,其中所述铁磁性材料包括粒子。
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