CN110327532A - 分开式球囊辅助装置及其使用方法 - Google Patents

分开式球囊辅助装置及其使用方法 Download PDF

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CN110327532A
CN110327532A CN201910251268.5A CN201910251268A CN110327532A CN 110327532 A CN110327532 A CN 110327532A CN 201910251268 A CN201910251268 A CN 201910251268A CN 110327532 A CN110327532 A CN 110327532A
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auxiliary device
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conduit
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J.罗伦佐
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DePuy Synthes Products Inc
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Abstract

本发明题为“分开式球囊辅助装置及其使用方法”。本发明公开了一种球囊辅助装置，所述球囊辅助装置包括内部主体和粘结到所述内部主体的球囊。所述内部主体沿着轴线从近侧端部延伸到远侧端部并且所述内部主体的截面部分地包围所述轴线。所述球囊辅助装置还包括充气管，所述充气管与由所述内部主体和所述护套包围的体积密封连通。所述球囊辅助装置还可以包括推动器，所述推动器用于使所述球囊辅助装置沿着所述导管滑动。所述推动器可以从所述球囊辅助装置的所述近侧端部沿近侧方向平行于所述轴线延伸。所述充气管也可以用作推动器。所述球囊辅助装置的所述内部主体可以是从所述近侧端部到所述远侧端部沿着所述轴线延伸的分开式柱体。

Description

分开式球囊辅助装置及其使用方法
技术领域
本公开大体涉及用于血管外科手术的工具领域。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
球囊引导导管有助于在缺血性应用中插入血管内装置以及控制/限制流动。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
为了解决现有技术中的这些缺陷，公开了一种球囊辅助装置，其包括内部主体和连结到所述内部主体的护套，从而包围内部主体与护套之间的体积。所述内部主体沿着轴线从近侧端部延伸到远侧端部并且所述内部主体的截面部分地包围所述轴线。所述球囊辅助装置还包括充气管，所述充气管与由所述内部主体和所述护套包围的体积密封连通。所述球囊辅助装置还可以包括推动器，所述推动器用于使所述球囊辅助装置沿着所述导管滑动。所述推动器可以从所述球囊辅助装置的所述近侧端部沿近侧方向平行于所述轴线延伸。所述充气管也可以用作推动器。所述球囊辅助装置的内部主体可以是从所述近侧端部到所述远侧端部沿着所述轴线延伸的分开式柱体。所述内部主体可以由弹性材料形成。
所述内部主体的分开式柱体由狭缝分开。狭缝可以是直的，从近侧端部到远侧端部平行于轴线，或者是螺旋的，从近侧端部到远侧端部围绕轴线螺旋地延伸。所述护套可以沿着周边粘结到内部主体，所述周边具有遵循所述分开式柱体的外表面的轮廓的四个侧部。所述护套可以是弹性材料或非弹性材料。
所述球囊辅助装置可以被设计成使得内部主体在导管的外部卡扣，其中所述可充气护套粘结到所述内部主体，例如通过使所述导管穿过所述内部主体中的狭缝。当在所述导管外部卡扣时，所述内部主体可沿所述导管滑动。所述球囊辅助装置可以经由所述推动器沿着所述导管滑动，所述推动器从所述球囊辅助装置沿近侧方向延伸。所述球囊辅助装置可以包括充气管，所述充气管与所述可充气护套密封连通。所述充气管还可以用于使所述球囊辅助装置沿着所述导管滑动。所述内部主体可以由弹性材料形成，所述弹性材料被构造成通过扩张所述内部主体中的狭缝，使所述导管穿过所述狭缝，并允许所述狭缝围绕所述导管收缩而卡扣在所述导管的外部上。
球囊辅助导管系统包括导管和球囊辅助装置，所述球囊辅助装置包括内部主体和粘结到所述内部主体的可充气护套。所述内部主体包括具有近侧端部和远侧端部的分开式柱体。所述分开式柱体可以通过从所述近侧端部延伸到所述远侧端部的直开口分开，或者通过从所述近侧端部到所述远侧端部围绕所述轴线螺旋延伸的螺旋形开口分开。所述球囊辅助装置可以包括从所述球囊辅助装置沿近侧方向延伸的推动器。所述推动器可以用于使所述球囊辅助装置沿着所述导管滑动。所述球囊辅助装置还可以包括充气管，所述充气管与可充气的所述护套密封连通。
一种使用球囊辅助装置的方法，其包括以下步骤：在所述球囊辅助装置的有弹性的内部主体中扩张狭缝，通过所扩张的狭缝插入导管，以及释放所扩张的狭缝以围绕所述导管收缩。所述方法还可以包括使用推动器来将所述球囊辅助装置沿着所述导管滑动到患者脉管系统中的治疗部位。所述方法还可以包括使用充气管来在所述治疗部位处对所述球囊辅助装置在充气。所述方法还可以包括当所充气的球囊辅助装置在所述治疗部位处闭塞血管时执行外科手术。所述方法还可以包括对所述球囊辅助装置放气以及撤回所放气的球囊辅助装置。
附图说明
图1是根据本公开的球囊辅助装置的图示，其示出了基本部件。
图2是根据本公开的球囊辅助装置的球囊组件的图示，其示出了结构。
图3是根据本公开的球囊辅助装置的球囊组件的图示，其示出了处于放气状态的球囊并突出显示了球囊与内部主体之间的密封件。
图4是根据本公开的球囊辅助装置的球囊组件的图示，其示出了处于充气状态的球囊并突出显示了球囊与内部主体之间的密封件。
图5是根据本公开的球囊辅助装置的球囊组件的图示，其示出了处于展平状态的球囊和内部主体。
图6是根据本公开的球囊辅助装置的替代性实施方案的图，其中内部主体具有螺旋狭缝。
图7是根据本公开的球囊辅助装置的球囊组件的替代性实施方案的图示，其示出了处于展平状态的球囊和内部主体，其中内部主体具有螺旋狭缝。
图8是根据本公开的正安装到导管主体的近侧端部的球囊辅助装置的图示。
图9是根据本公开的安装在导管主体的近侧端部上的球囊辅助装置的图示。
图10是根据本公开的安装在导管主体上并定位在导管远侧端部处的球囊辅助装置的图示。
图11是根据本公开的在导管远侧端部处充气的球囊辅助装置球囊的图示。
图12是根据本公开的定位在患者脉管系统中的导管的图示，其中球囊辅助装置安装到导管主体的近侧端部。
图13是根据本公开的定位在患者脉管系统中的导管的图示，其中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14是根据本公开的定位在患者脉管系统中的导管的图示，其中球囊在治疗部位处充气，从而闭塞血管。
图15是示出根据本公开的用于使用球囊辅助装置的方法的一个实施方案的流程图。
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件，将详细公开球囊辅助装置的各种实施方案及其使用方法。图1是球囊辅助装置100的示意图，示出了基本部件。球囊辅助装置100包括球囊组件200、充气管104和充气端口106。图2是球囊组件200的近距离视图。球囊组件200包括固定到内部主体204的球囊202。在替代性示例中，内部主体204可以与球囊202一体地形成。内部主体沿着轴线208从近侧端部210延伸到远侧端部212，并且包括用于将球囊辅助装置100安装到导管的狭缝206。因此，内部主体204部分地包围轴线208。图3和图4示出了将球囊202附接到内部主体204的一个实施方案。在该实施方案中，球囊202包括柔性材料的护套214，其围绕护套214的周边216连结到内部主体204。护套214可以由合适的弹性材料或非弹性材料制成，包括聚酰亚胺。包围在护套214与内部主体204之间的体积变成球囊202。
图3示出了处于放气状态的球囊202。图4示出了处于充气状态的球囊202。尽管示出了球囊202的特定形状，但本公开不限于所示的形状。使用充气管104来使球囊202充气。可以在充气端口106处将无菌水、盐水或其他合适的溶液引入充气管104。充气端口106可以是工业中已知的若干类型之一。在另一个实施方案中，球囊202和内部主体204彼此一体地形成。
狭缝206沿着内部主体204的长度L设置，并且在某些示例中完全通过该内部主体204的长度以允许球囊辅助装置安装到导管240的外部。导管240可以小至6-8F，这增强了本发明进入远侧脉管系统的能力。为了将球囊辅助装置100安装在导管240上，将狭缝206展开并使导管240穿过狭缝。然后重新闭合狭缝206。在一个实施方案中，内部主体204由弹力材料(诸如弹簧韧度不锈钢)制成或者更优选地由超弹性材料(诸如镍钛诺)制成。在这样的实施方案中，由于内部主体204的弹性性质，内部主体204中的狭缝206将自身重新闭合。在另一个实施方案中，内部主体204与球囊202一体形成。
图5示出了球囊组件102首先以扁平构造组装的一个示例，其中内部主体204和护套214的形状可以更容易切割。扁平构造还允许护套214更容易地围绕护套周边216周密封到内部主体204。护套214可以使用工业中众所周知的各种技术(包括但不限于粘合剂、热粘结和射频(RF)粘结)来密封到内部主体204。除了护套214与内部主体204之间的密封之外，充气管104与球囊202的内部体积进行密封连通。充气管104可以由金属制成以便有助于球囊202沿导管240的推动，由聚合物材料(诸如聚酰亚胺)制成以用于柔性，或者在近侧端部210处由金属制成并在它朝向远侧端部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可用于在远侧方向上沿导管240推进球囊辅助装置100并使其在近侧方向上缩回。在其他实施方案中，单独推动器(未示出)可以附接到内部主体204，在远侧方向上沿导管240推进球囊辅助装置100并使其在近侧方向上缩回，从而允许充气管更柔韧。
在将护套214密封到内部主体204之后，扁平球囊组件200可以形成为用于安装到导管240的合适形状。在某些示例中，球囊辅助装置100可能以平面取向制造/运输并且由临床医生围绕导管弯曲。内部主体204的最终形状部分地包围导管240，其牢固程度足以在手术期间在患者脉管系统内沿着导管主体进行跟踪。在所示的实施方案中，内部主体204具有圆柱形形状，但根据需要可以使用其他截面。
在图5所示的实施方案中，内部主体204中的狭缝206是直的。也就是说，狭缝206平行于轴线208和导管240。在图6中示出了具有螺旋狭缝228的替代性实施方案。在该实施方案中，螺旋狭缝214围绕轴线208和导管240缠绕至少四分之一圈。该实施方案的预成形扁平形式在图7中示为形成螺旋狭缝228的非限制性示例。代替矩形，内部主体224和护套226被切割成梯形(未示出)。当这些形成为圆柱体时，它们产生螺旋形狭缝228。
图8-图11示出了球囊辅助装置100的基本操作。在图9中，球囊辅助装置100安装在导管240上。如上所述，狭缝206展开得足够宽以接受导管240。为了简化该过程，可以首先展开狭缝206的拐角220以接受导管240，并且通过在剩下的部分中将球囊辅助装置100完全扭转到导管240上来完成该过程，如图8所示。图9示出了在近侧端部位置230处完全安装在导管240上的球囊辅助装置100。然后使用充气管104或单独推动器(未示出)来使球囊辅助装置100沿着导管240滑动。图10示出了在沿着导管240滑动之后在远侧位置232中安装在导管240上的球囊辅助装置100。然后使用充气管104来使球囊202充气，如图11所示。
图12-图14示出了球囊辅助装置100在医疗手术期间的基本操作。图12示出了完全安装在导管240上的近侧位置230中的球囊辅助装置100，临床医生已将该导管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或单独推动器(未示出)来使球囊辅助装置100沿着导管240滑动到治疗部位250。图10示出了在治疗部位250处的远侧位置232中安装在导管240上的球囊辅助装置100。然后使用充气管104来使球囊202充气以闭塞患者脉管系统252的一部分，如图11所示。
图15是示出用于使用球囊辅助装置100的步骤的流程图。在1500处，扩张狭缝206。在1502处，通过扩张的狭缝206插入导管240。在1504处，释放扩张的狭缝206以围绕导管240收缩，从而将球囊辅助装置100牢固且可滑动地安装到导管240。其余步骤基于临床手术是可选的。在1506处，使用推动器将球囊辅助装置100沿导管240滑动到患者脉管系统252中的治疗部位250。在一些实施方案中，推动器可以是充气管104。在1508处，使用充气管104在治疗部位250处使球囊辅助装置100充气。可替代地，在1510处执行手术，同时充气的球囊辅助装置100闭塞治疗部位250处的血管。在1512处，使球囊辅助装置100放气。在1514，撤回放气的球囊辅助装置100。
为了便于理解所公开技术的原理和特征结构，下面解释了例示性实施方案。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。
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。
以上参考流程图描述了该技术的某些实施方案。根据本公开的一些实施方案，框图和流程图的一些框可能不一定需要以所呈现的顺序执行，或者根本不一定需要执行。
虽然已经结合目前被认为是最实际的内容和各种实施方案描述了本公开的某些实施方案，但是应当理解，本公开内容不限于所公开的实施方案，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实施方案，并且还使得本领域任何技术人员能够实践该技术的某些实施方案，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。该技术的某些实施方案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)

1.一种球囊辅助装置，包括：
内部主体，所述内部主体沿着轴线从近侧端部延伸到远侧端部并包括部分地包围所述轴线的截面；
球囊，所述球囊连结到所述内部主体。
2.根据权利要求1所述的球囊辅助装置，其中所述球囊包括粘结到所述内部主体的柔性材料的护套和所述护套与所述内部主体之间的体积，所述体积包括所述球囊的内部。
3.根据权利要求1所述的球囊辅助装置，还包括充气管，所述充气管与所述球囊密封连通。
4.根据权利要求1所述的球囊辅助装置，还包括推动器，所述推动器从所述球囊辅助装置的所述近侧端部沿近侧方向平行于所述轴线延伸。
5.根据权利要求4所述的球囊辅助装置，还包括充气管，所述充气管与所述球囊密封连通。
6.根据权利要求2所述的球囊辅助装置，其中所述内部主体包括分开式柱体，所述分开式柱体从所述近侧端部到所述远侧端部沿所述轴线延伸。
7.根据权利要求6所述的球囊辅助装置，其中所述内部主体由弹性材料形成。
8.根据权利要求7所述的球囊辅助装置，其中所述分开式柱体包括从所述近侧端部到所述远侧端部平行于所述轴线的直狭缝。
9.根据权利要求7所述的球囊辅助装置，其中所述分开式柱体包括螺旋狭缝，所述螺旋狭缝从所述近侧端部到所述远侧端部围绕所述轴线螺旋延伸。
10.根据权利要求6所述的球囊辅助装置，其中所述护套沿着周边粘结到内部主体，所述周边具有遵循所述分开式柱体的外表面的轮廓的四个侧部。
11.根据权利要求10所述的球囊辅助装置，其中所述护套包括弹性材料。
12.一种球囊辅助导管系统，包括：
导管；
球囊辅助装置，所述球囊辅助装置可移除地接合所述导管的外部，所述球囊辅助装置包括：
内部主体，所述内部主体包括具有近侧端部和远侧端部的分开式柱体；和
可充气球囊，所述可充气球囊粘结到所述内部主体。
13.根据权利要求12所述的球囊辅助导管系统，其中所述分开式柱体由从所述近侧端部延伸到所述远侧端部的直开口分开。
14.根据权利要求12所述的球囊辅助导管系统，其中所述球囊辅助装置还包括推动器，所述推动器从所述球囊辅助装置沿近侧方向延伸。
15.根据权利要求12所述的球囊辅助导管系统，其中所述球囊辅助装置还包括充气管，所述充气管与可充气的所述护套密封连通。
16.一种使用球囊辅助装置的方法，包括以下步骤：
在所述球囊辅助装置的有弹性的内部主体中扩张狭缝；
通过所扩张的狭缝插入导管；
释放所扩张的狭缝以围绕所述导管收缩。
17.根据权利要求16所述的方法，还包括使用推动器来将所述球囊辅助装置沿着所述导管滑动到患者脉管系统中的治疗部位。
18.根据权利要求17所述的方法，还包括使用充气管来在所述治疗部位处对所述球囊辅助装置充气。
19. 根据权利要求18所述的方法，还包括当所充气的球囊辅助装置在所述治疗部位处闭塞血管时执行外科手术。
20.根据权利要求19所述的方法，还包括对所述球囊辅助装置放气；以及
撤回所放气的球囊辅助装置。
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