CN110327537A - 螺旋球囊辅助装置以及使用该装置的方法 - Google Patents

螺旋球囊辅助装置以及使用该装置的方法 Download PDF

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CN110327537A
CN110327537A CN201910251269.XA CN201910251269A CN110327537A CN 110327537 A CN110327537 A CN 110327537A CN 201910251269 A CN201910251269 A CN 201910251269A CN 110327537 A CN110327537 A CN 110327537A
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J.罗伦佐
K.约翰逊
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DePuy Synthes Products Inc
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Abstract

本发明题为“螺旋球囊辅助装置以及使用该装置的方法”。本发明提供了一种螺旋球囊辅助装置,所述螺旋球囊辅助装置包括管状球囊和充气管,所述管状球囊在未充气状态下至少部分地形成为独立螺旋形状,并且所述充气管与所述球囊密封连通,并且在近侧方向上从所述螺旋球囊辅助装置延伸。所述螺旋球囊辅助装置可包括内芯构件,所述内芯构件至少部分地形成为独立螺旋形状并支撑所述管状球囊的螺旋形状。

Description

螺旋球囊辅助装置以及使用该装置的方法
技术领域
本公开整体涉及用于血管外科手术的工具的领域。更具体地,本发明涉及用于在血管外科手术期间闭塞血管的球囊装置。
背景技术
球囊引导导管便于插入血管内装置以及控制/限制缺血应用中的血流。它们被设计成具有大的管腔以最大化凝块捕获,并且指示用作凝块检索装置的导管。因为球囊是这些装置上组件的整体部分,所以与尺寸可为6F(2.0mm)(French“F”=0.33mm)的常规大ID引导导管相比,所述装置的轮廓非常大,例如8F(2.7mm)。而且,由于需要充气远侧球囊所需的充气管腔和双层构造,系统的整体柔韧性降低。大的整体轮廓和缺乏远侧柔韧性的组合使得在神经血管解剖结构中跟踪这些装置变得困难。因此,这些装置的使用主要限于近侧脑血管系统。
发明内容
为解决现有技术中的这些缺陷,螺旋球囊辅助装置可包括管状球囊和充气管,所述管状球囊在未充气状态下至少部分地形成为独立螺旋形状,所述充气管与球囊密封连通,并且在近侧方向上从螺旋球囊辅助装置延伸。螺旋球囊辅助装置还可具有内芯构件,所述内芯构件至少部分地形成为独立螺旋形状并支撑管状球囊的螺旋形状。在示例中,内芯构件可由弹性材料形成。
其他示例具有固定到球囊或者固定到最靠近或最远离螺旋轴线的球囊壁的内部部分的内芯构件。内芯构件可通过粘合剂、焊接,或通过机械紧固固定到球囊壁。其他示例具有未固定到球囊的内芯构件。内芯构件可形成为多重螺旋形状,其中第二螺旋沿管状球囊的壁螺旋地延伸。球囊的示例包括其由弹性材料或非弹性材料制成。
螺旋球囊辅助装置也可具有由弹性材料制成的定位器,并且在某些示例中,定位器为充气管。定位器可被构造成在径向上定位螺旋球囊辅助装置。
螺旋球囊辅助装置可与具有导管和螺旋球囊辅助装置的导管系统配对,以可滑动地接合导管的外部。
使用螺旋球囊辅助装置的示例性方法可包括以下步骤,使螺旋球囊辅助装置的球囊的远侧匝变形,以在螺旋球囊辅助装置的球囊的两个匝之间产生或扩张间隙。然后将导管插入穿过球囊的匝之间的间隙,扭转螺旋球囊辅助装置以将螺旋球囊辅助装置完全安装到导管上,以及使用充气管或定位器将螺旋球囊辅助装置沿导管滑动到患者脉管系统中的治疗部位。该方法还可包括以下步骤,使用充气管对螺旋球囊辅助装置的球囊充气,然后执行临床手术。然后,使用充气管对螺旋球囊辅助装置的球囊放气,以及
从患者身上撤出螺旋球囊辅助装置。在这些示例中,使螺旋球囊辅助装置的球囊充气导致邻近治疗部位的患者的血管至少部分闭塞。
附图说明
图1是根据本公开的螺旋球囊辅助装置的示意图,其示出了螺旋球囊辅助装置的基本部件。
图2是根据本公开的螺旋球囊辅助装置的球囊组件的示意图,其示出了处于放气状态的球囊。
图3是根据本公开的螺旋球囊辅助装置的球囊组件的示意图,其示出了处于充气状态的球囊。
图4A是根据本公开的螺旋球囊辅助装置的球囊组件的横截面图,其示出了定位在球囊内靠近导管外径的内芯构件的一个示例。
图4B是根据本公开的螺旋球囊辅助装置的球囊组件的横截面图,其示出了定位在球囊内远离导管外径的内芯构件的一个示例。
图4C是根据本公开的螺旋球囊辅助装置的球囊组件的横截面图,其示出了定位在球囊壁内的内芯构件的一个示例。
图4D是根据本公开的螺旋球囊辅助装置的球囊组件的横截面图,其示出了以多螺旋形状定位在球囊内的内芯构件的一个示例。
图5是根据本公开的将螺旋球囊辅助装置安装在导管主体的近侧端部上的示意图。
图6是根据本公开的安装完全安装在导管主体的近侧端部上的螺旋球囊辅助装置的示意图。
图7是根据本公开的安装在导管主体上并位于导管远侧端部处的螺旋球囊辅助装置的示意图。
图8是根据本公开的在导管的远侧端部处充气的螺旋球囊辅助装置的球囊的示意图。
图9是根据本公开的定位在患者脉管系统中的导管的示意图,其中螺旋球囊辅助装置安装到导管主体的近侧端部。
图10是根据本公开的定位在患者脉管系统中的导管的示意图,其中螺旋球囊辅助装置在治疗部位处定位在导管主体的远侧端部上。
图11是根据本公开的定位在患者脉管系统中的导管的示意图,其中球囊在治疗部位处充气,闭塞血管。
图12是示出根据本公开的使用螺旋球囊辅助装置的方法的一个示例的流程图。
具体实施方式
现在参考附图,其中相同的附图标记表示相同的部分,将详细地公开螺旋球囊辅助装置及其使用方法的各种示例。图1为示出其基本部件的螺旋球囊辅助装置的示意图。螺旋球囊辅助装置100包括球囊组件200、充气管104和充气口106。图2是球囊组件200的近视图。球囊组件包括由内芯构件204支撑的球囊202。球囊202可由弹性或半弹性材料诸如聚酰亚胺形成。球囊202沿轴线208并且围绕轴线208从近侧端部210螺旋地延伸到远侧端部212。内芯构件204为支撑球囊202的螺旋元件。在一个示例中,内芯构件204可为线材。尽管球囊202的具体形状示出,但本发明不局限于所示的形状。
球囊202可以在一端或两端处具有平行于轴线208延伸的平直节段214。平直节段214可以改善与充气管104的结合的坚固性,可以改善球囊202在导管240上的抓握,或者可以改善沿导管240跟踪球囊202的容易性。另选地,球囊202可以是纯螺旋状的。球囊202的螺旋部分250由管直径252描述,标称直径254限定球囊202的匝与轴线208之间的距离,以及球囊202的匝之间的节距256。管直径252可为恒定的或可变的。在一些示例中,管直径252可朝向球囊202的端部212渐缩。节距256可为恒定的或可为可变的。在一个示例(未示出)中,球囊202可具有“闭合”端部,其中部分匝为非螺旋的,但替代地具有零节距并且沿循垂直于轴线208的平面围绕导管缠绕,该端部类似于螺旋压缩弹簧的“闭合”端部。
使用充气管104使球囊202充气。可以在充气口106处将无菌水、盐水或其他适当的溶液引入充气管104。充气口106可为行业中已知的多种类型中的一种。充气管104具有终止于球囊202内部的开口端218。充气管104的外周边在其开口端218近侧的位置处结合到球囊202。该结合提供气密密封和坚固的机械附接,以在使用螺旋球囊辅助装置100期间承受力。
充气管104可由金属制成以有利于球囊202沿导管240的可推性,由聚合物材料诸如聚酰亚胺制成以获得柔韧性,或者在近侧端部210处的金属并且当其朝远侧端部212延伸时过渡到聚合物材料的组合。在一些示例中,充气管104可用于沿导管240在远侧方向上定位螺旋球囊辅助装置100并将其在近侧方向上回缩。在一些示例中,充气管104可连接到内芯构件204。在其他示例中,可将单独的定位器(未示出)附接到球囊202和/或内芯构件204,以沿导管240在远侧方向上推进螺旋球囊辅助装置100并在近侧方向上回缩螺旋囊辅助装置100,从而允许充气管104更具柔性。定位器可由弹性材料诸如弹簧回火不锈钢或更优选地镍钛诺制成。在若干示例中,定位器可通过焊接(例如通过激光或超声方法)、粘合剂、压接或热铆接来附接,这取决于定位器、内部主体104和/或球囊202的材料。
球囊组件200的长度L在轴向上可相对较短。在一个示例中,球囊组件200可小于或等于导管240的外径D的两倍(参见图6)。在另一个示例中,球囊组件200可小于或等于导管240的外径D。短长度L允许球囊组件200在引导它的导管240的更紧凑半径弯曲之上跟踪。
图4A-4D示出内芯构件204的示例。在一个示例中,内芯构件204由弹性材料诸如弹簧回火不锈钢或更优选地超弹性材料诸如镍钛诺制成。内芯构件204具有支撑球囊202的螺旋形状。内芯构件204可固定到球囊202或可在球囊202内松散。内芯构件204可通过粘合剂、超声焊接、机械紧固件、热铆接,或本领域的技术人员已知的其他方法固定。如果固定到球囊202,内芯构件204可固定到球囊202的内部216,球囊202的外部或球囊202的壁220内,如图4C所示。内芯构件204也可通过粘合剂、超声焊接、机械紧固件、热铆接,或本领域技术人员已知的其他技术固定到充气管104。在一个示例中,如图4A所示,内芯构件204可以形成为沿循球囊202的最靠近导管240的壁220的螺旋,即,具有与导管240的外径242类似的标称直径的螺旋。在另一个示例中,如图4B所示,内芯构件204可以形成为沿循球囊202的最远离导管240的壁220的螺旋,即,具有大约等于导管240的外径(由周长242示出)加上球囊202的管直径的两倍的标称直径。
在另一个示例中,内芯构件204可形成为螺旋地沿循球囊202的螺旋形状的内壁220的多重螺旋222,如图4D所示。多重螺旋222具有大约等于球囊的管直径的标称直径,并且沿逼近沿循球囊管中心的花键的轴线螺旋卷绕。因此,多重螺旋222类似于包在导管240上的长螺旋弹簧。多重螺旋222可例如机械地或通过以某种形式热处理内芯构件204而形成。
图5-8示出螺旋球囊辅助装置100的基本操作。图5示出通过以螺旋方式扭转而暂时变形并安装在导管上的球囊辅助装置。球囊202的远侧端部212变形以在球囊202的最远侧匝和最下一个远侧匝之间产生间隙226。图6示出在近侧位置230中完全安装在导管上的螺旋球囊辅助装置。然后使用充气管104或单独的定位器(未示出)沿导管240滑动螺旋球囊辅助装置100。图7示出在沿导管240滑动之后在远侧位置232中安装在导管240上的螺旋球囊辅助装置100。然后使用充气管104使球囊202充气,如图8所示。
图9-11示出在医疗手术期间螺旋球囊辅助装置100的基本操作。图9示出完全安装在导管240上的近侧位置230中的螺旋球囊辅助装置100,临床医生可已经将其定位在患者脉管系统252内的治疗部位250处。然后使用充气管104或单独的定位器(未示出)沿导管240将螺旋球囊辅助装置100滑动到治疗部位250。图10示出在治疗部位250处在远侧位置232处安装在导管240上的螺旋球囊辅助装置100。然后使用充气管104使球囊202充气以闭塞患者脉管系统252的一部分,如图11所示。在一些示例中,可在临床手术期间使用螺旋球囊辅助装置100以闭塞血流,闭塞或捕获通过手术释放的组织、斑块或碎屑,或将导管240保持在血管中的适当位置。
图12是示出使用螺旋球囊辅助装置100的步骤的流程图。在1200处,球囊的远侧端部变形以在螺旋的匝之间产生或扩张间隙226。在1202处,将导管240插入穿过球囊226的匝之间的间隙202。在1204处,螺旋球囊辅助装置100以螺旋方式被完全扭转到导管240上。在1206处,使用充气管104或定位器将螺旋球囊辅助装置100沿导管240滑动到患者脉管系统252中的治疗部位250。在一些示例中,定位器可为充气管104。在1208处,使用充气管104在治疗部位250处使螺旋球囊辅助装置100充气。其余步骤基于临床手术是可选的。在1210处,执行手术,同时充气的螺旋球囊辅助装置100闭塞治疗部位250处的血管。在1212处,螺旋球囊辅助装置100放气。在1214处,将放气的螺旋球囊辅助装置100撤出。
为了便于理解所公开技术的原理和特征结构,上面解释了例示性示例。在下文中被描述为构成所公开技术的各种元件部件旨在是说明性的而非限制性的。将执行与本文所描述的部件相同或相似功能的许多合适的部件旨在涵盖在所公开的装置和方法的范围内。本文未描述的此类其他部件可包括但不限于例如在所公开的技术开发之后开发的部件。
尽管示例描述将螺旋球囊辅助装置安装在导管上,但其可类似地与导丝、管腔或任何类似的细长血管外科工具一起使用。
还应该注意的是,除非上下文清楚地指明,否则本说明书和所附权利要求中所用的单数形式“一个/一种”和“所述/该”包括复数指代物。“包含”或“含有”或“包括”是指至少命名的部件或方法步骤存在于制品或方法中,但不排除存在其他部件或方法步骤,即使其他此类部件或方法步骤具有与命名的那些相同的功能。
还应当理解,提到一个或多个方法步骤不排除存在附加的方法步骤或在那些明确标识的步骤之间的中间方法步骤。类似地,还应当理解,提到装置或系统中的一个或多个部件不排除存在附加的部件或在那些明确标识的部件之间的中间部件。
本专利申请中描述的设计和功能本质上旨在是示例性的,并且并不旨在以任何方式限制本公开。本领域普通技术人员将理解,本公开的教导可以以各种合适的形式来实现,包括本文公开的那些形式以及本领域普通技术人员已知的附加形式。
上文结合流程图描述了该技术的某些示例。根据本公开的一些示例,框图和流程图的一些块可不一定需要按所呈现的顺序来执行,或者不一定需要完全执行。
虽然已经结合目前被认为是最实际的内容和各种示例描述了本公开的某些示例,但是应当理解,本公开内容不限于所公开的示例,而相反地,旨在涵盖包括在所附权利要求的范围内的各种修改形式和等同布置。尽管本文采用了特定术语,但是这些术语仅以一般性意义和描述性意义被使用并且不出于限制的目的。
该书面描述使用示例来公开技术的某些示例,并且还使得本领域任何技术人员能够实践该技术的某些示例,包括制造和使用任何设备或系统并执行任何所包括的方法。该技术的某些示例的可取得专利的范围在权利要求中加以定义,并且可包括本领域技术人员想到的其他示例。如果这些其他示例具有与权利要求的文字语言相同的结构元件,或者如果它们包括与权利要求的文字语言无实质差异的等同的结构元件,则此类其他示例旨在处于权利要求的范围内。

Claims (20)

1. 一种螺旋球囊辅助装置,包括:
管状球囊,所述管状球囊在未充气状态下至少部分地形成为独立螺旋形状;和
充气管,所述充气管与所述球囊密封连通,并且在近侧方向上从所述螺旋球囊辅助装置延伸。
2.根据权利要求1所述的螺旋球囊辅助装置,还包括内芯构件,所述内芯构件至少部分地形成为独立螺旋形状并支撑所述管状球囊的所述螺旋形状。
3.根据权利要求2所述的螺旋球囊辅助装置,其中所述内部芯构件由弹性材料形成。
4.根据权利要求2所述的螺旋球囊辅助装置,其中所述内部芯构件固定到所述球囊。
5.根据权利要求4所述的螺旋球囊辅助装置,其中所述内芯构件固定到最靠近螺旋轴线的球囊壁的内部部分。
6.根据权利要求4所述的螺旋球囊辅助装置,其中所述内芯构件固定到最远离螺旋轴线的球囊壁的内部部分。
7.根据权利要求4所述的螺旋球囊辅助装置,其中所述内芯构件通过粘合剂、通过焊接或通过机械紧固固定到球囊壁。
8.根据权利要求2所述的螺旋球囊辅助装置,其中所述内芯构件形成为多重螺旋形状,所述多重螺旋形状包括沿所述管状球囊的壁螺旋延伸的第二螺旋。
9.根据权利要求2所述的螺旋球囊辅助装置,其中所述内芯构件不固定到所述球囊。
10.根据权利要求1所述的螺旋球囊辅助装置,其中所述球囊包括弹性材料。
11.根据权利要求1所述的螺旋球囊辅助装置,其中所述球囊包括非弹性材料。
12.根据权利要求1所述的螺旋球囊辅助装置,还包括由弹性材料制成的定位器。
13.根据权利要求13所述的螺旋球囊辅助装置,其中所述定位器包括所述充气管。
14.根据权利要求13所述的螺旋球囊辅助装置,其中所述定位器被构造成在径向上定位所述螺旋球囊辅助装置。
15. 一种螺旋球囊辅助导管系统,包括:
导管;和
螺旋球囊辅助装置,所述螺旋球囊辅助装置可滑动地接合所述导管的外部,所述螺旋球囊辅助装置包括:
管状球囊,所述管状球囊在未充气状态下至少部分地形成为独立螺旋形状;和
充气管,所述充气管与所述球囊密封连通,并且在近侧方向上延伸。
16.根据权利要求18所述的球囊辅助导管系统,其中所述充气管包括定位器。
17.根据权利要求18所述的球囊辅助导管系统,其中所述螺旋球囊辅助装置还包括内芯构件,所述内芯构件至少部分地形成为独立螺旋形状并支撑所述管状球囊的所述螺旋形状。
18.一种使用螺旋球囊辅助装置的方法,所述方法包括:
使所述螺旋球囊辅助装置的球囊的远侧匝变形,以在所述螺旋球囊辅助装置的所述球囊的两个匝之间产生或扩张间隙中;
将导管插入通过所述球囊的所述两个匝之间的所述间隙;
扭转所述螺旋球囊辅助装置以将所述螺旋球囊辅助装置完全安装到所述导管上;以及
使用充气管或定位器中的一个将所述螺旋球囊辅助装置沿所述导管滑动到患者脉管系统中的治疗部位。
19.根据权利要求18所述的方法,还包括以下步骤:
使用所述充气管对所述螺旋球囊辅助装置的所述球囊充气;
执行临床手术;
使用所述充气管对所述螺旋球囊辅助装置的所述球囊放气;以及
从所述患者身上撤出所述螺旋球囊辅助装置。
20.根据权利要求19所述的方法,其中对所述螺旋球囊辅助装置的所述球囊充气导致患者的邻近所述治疗部位的血管至少部分闭塞。
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