CN101019775A - 用于封闭血管的方法、医疗系统和医疗器械 - Google Patents

用于封闭血管的方法、医疗系统和医疗器械 Download PDF

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CN101019775A
CN101019775A CNA2007100791718A CN200710079171A CN101019775A CN 101019775 A CN101019775 A CN 101019775A CN A2007100791718 A CNA2007100791718 A CN A2007100791718A CN 200710079171 A CN200710079171 A CN 200710079171A CN 101019775 A CN101019775 A CN 101019775A
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J·D·梅瑟利
S·K·诺恩费尔特
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Abstract

一种医疗器械，包括医疗端部执行器和用户致动介质输送器。所述医疗端部执行器包括超声传播元件并包括当沿着其输送时适于将药剂定向到所述超声传播元件的路径。所述用户致动介质输送器适于沿着所述路径输送药剂并使之与所述超声传播元件接触。一种医疗系统，包括医疗器械和用户致动止血剂输送器。所述医疗器械适于处理患者组织并且是基于机械的结扎器械或者基于能量的结扎器械。所述用户致动止血剂输送器适于将止血剂输送到患者组织。一种用于封闭患者的血管的方法，包括将止血剂施加到血管，并包括使用医疗器械处理血管，所述医疗器械是基于机械的结扎器械或者基于能量的结扎器械。

Description

用于封闭血管的方法、医疗系统和医疗器械
技术领域
本发明总的涉及外科器械和外科方法，更具体地涉及：用于封闭患者血管的方法；包括基于机械或者能量的结扎器械的医疗系统，所述结扎器械例如是超声外科剪、夹具施放器、缝合器和RF(射频)双极血管闭合器；以及具有包括超声传播元件的医疗端部执行器的医疗器械。
背景技术
传统的超声外科剪包括具有超声外科刀以及可操作地向着所述刀打开和闭合的夹钳臂的端部执行器，其中超声外科刀适于以20千赫到500千赫范围内的频率振动。在一种已知的应用中，超声外科剪被用作基于能量的结扎器械，所述结扎器械用于横切并封闭患者的血管或者其它组织。其它传统结扎器械包括夹具施放器、缝合器和RF(射频)双极血管闭合器。已知的药剂包括止血剂(诸如凝血剂)，其它治疗剂(诸如药物)，以及组织成像增强材料(诸如用于改进X光照相术成像的组织染料)。医疗注射器已知为用于将流体施加到患者组织。
然而，科学家和工程师仍在继续探索具有包括超声传播元件的医疗端部执行器的改进的医疗器械，包括基于机械或者能量的结扎器械的改进的医疗系统，和用于封闭患者血管的改进方法。
发明内容
本发明的第一种实施方式是包括医疗端部执行器和用户致动的介质输送器的医疗器械。所述医疗端部执行器包括超声传播元件并包括当沿着其输送时适于将药剂定向到超声传播元件的路径。所述用户致动介质输送器适于沿着所述路径输送药剂并与超声传播元件接触。
本发明的第二种实施方式是包括医疗器械和用户致动的止血剂输送器的医疗系统。所述医疗器械适于处理患者组织并选自包括基于机械的结扎器械和基于能量的结扎器械的组。用户致动止血剂输送器适于将止血剂输送到患者组织。
本发明的方法用于封闭患者的血管。所述方法包括将止血剂施加到血管。所述方法包括使用医疗器械处理血管，所述医疗器械选自包括基于机械的结扎器械和基于能量的结扎器械的组。
可通过本发明的一种或多种方法和实施方式得到许多益处和优点。在一个例子中，当沿着所述路径借助机械平移、机械旋转、机械平移并旋转、流体压力差等等输送时，药剂具有更粘稠状态，并且当由超声传播元件超声振动时具有较小的粘稠状态，所述超声传播元件允许药剂的改进扩散。在另一个例子中，将止血剂输送到患者组织(诸如将止血剂应用到血管)能够在使用基于机械或者基于能量的结扎器械对患者组织(诸如血管)进行处理时促进止血。
本发明适用于(但不限于)手致动器械以及机器人辅助器械。
更具体地说，本发明涉及如下内容：
(1)一种医疗器械，包括：
a)医疗端部执行器，包括超声传播元件并包括当沿着其输送时适于将药剂定向到超声传播元件的路径；以及
b)用户致动介质输送器，适于沿着所述路径输送所述药剂并使所述药剂与所述超声传播元件接触。
(2)如第(1)项所述的医疗器械，还包括药剂，其中当沿着所述路径输送时，所述药剂具有更粘稠状态，并且当由所述超声传播元件超声振动时，所述药剂具有较小的粘稠状态。
(3)如第(2)项所述的医疗器械，其中，当沿着所述路径输送时，所述药剂具有更粘稠的液态，并且当由所述超声传播元件超声振动时，所述药剂具有较小粘稠的液态。
(4)如第(3)项所述的医疗器械，其中，所述路径包括通道，其中所述用户致动介质传输器包括注射器。
(5)如第(2)项所述的医疗器械，其中，当沿着所述路径输送时所述药剂处于固态，当由所述超声传播元件超声振动时所述药剂处于液态。
(6)如第(5)项所述的医疗器械，其中，所述用户致动介质输送器包括推动滑块。
(7)如第(2)项所述的医疗器械，其中，所述超声传播元件适于以范围在20千赫到500千赫范围内的频率振动。
(8)如第(2)项所述的医疗器械，其中，所述路径包括通道，并且其中所述用户致动介质输送器适于在通道中输送药剂。
(9)如第(2)项所述的医疗器械，其中，所述路径包括管形的杆，其中所述药剂具有环形形状并适于安放在所述杆上，其中所述用户致动介质输送器适于沿着所述杆输送所述药剂。
(10)一种使用如第(2)项所述的医疗器械对患者组织进行医疗处理的方法，包括下列步骤：
a)将医疗端部执行器设置到待进行医疗处理的患者组织附近；
b)使用用户致动介质输送器沿着路径输送处于更粘状态的药剂并使之与超声传播元件接触；
c)致动所述超声传播元件使所述药剂热变化到粘度较小的状态以扩散所述药剂；以及
d)使所述超声传播元件解除致动，从而使扩散的药剂热恢复到更粘的状态。
(11)如第(10)项所述的方法，其中，所述药剂具有至少一种选自如下的组中的效果，所述效果的组包括：组织标记、组织部位成像增强、借助压塞凝结、借助化学诱导的凝集促进凝结、细胞死亡、组织生长抑制、组织消融、组织膨胀、感染抑制、痛苦减轻、细胞生长/移植、组织靠近、装置靠近以及植入物靠近。
(12)如第(10)项所述的方法，其中，所述用户致动介质输送器包括导螺杆。
(13)如第(10)项所述的方法，还包括使用涂层材料涂覆所述药剂以降低所述药剂对所述超声传播元件的粘接。
(14)一种医疗系统，包括：
a)医疗器械，适于处理患者组织并选自包括基于机械的结扎器械和基于能量的结扎器械的组；和
b)用户致动止血剂输送器，适于将止血剂输送到患者组织。
(15)如第(14)项所述的医疗系统，其中，所述患者组织包括血管，其中所述医疗器械是适于横切血管的基于能量的结扎器械，其中所述基于能量的结扎器械包括超声外科剪。
(16)如第(14)项所述的医疗系统，其中，所述用户致动止血剂输送器包括适于将止血剂喷洒到患者组织上的弥雾机。
(17)如第(14)项所述的医疗系统，其中，当由能量致动时，所述止血剂具有止血特性，并且所述医疗器械是适于活化所述止血剂的止血特性的基于能量的结扎器械。
(18)如第(17)项所述的医疗系统，其中，所述止血剂包括适于由来自基于能量的结扎器械的能量变性形成凝集的蛋白质。
(19)一种用于封闭患者血管的方法，包括下列步骤：
a)将止血剂施加到血管；和
b)使用医疗器械处理血管，所述医疗器械选自包括基于机械的结扎器械和基于能量的结扎器械的组。
(20)如第(19)项所述的方法，其中，所述医疗器械是基于机械的结扎器械，其中所述基于机械的结扎器械选自包括夹具施放器和缝合器的组。
(21)如第(19)项所述的方法，其中，所述医疗器械是基于能量的结扎器械，其中所述基于能量的结扎器械选自包括超声外科剪和双极血管闭合器的组。
(22)如第(21)项所述的方法，其中，所述止血剂包括适于利用来自基于能量的结扎器械的能量被变性形成凝集的蛋白质。
(23)如第(21)项所述的方法，其中，所述基于能量的结扎器械是具有插脚的超声外科剪，其中所述止血剂包括套筒，所述套筒包括凝结物并适于由所述插脚承载。
(24)如第(19)项所述的方法，其中，所述止血剂选自包括胶水和环氧树脂的组。
附图说明
图1是本发明的第一种实施方式的示意性侧剖视图，其中医疗器械包括医疗端部执行器(其以剖面显示)中的通道型路径，用于在其中将药剂输送到医疗端部执行器的超声传播元件，所述医疗器械还包括输送通道中的药剂的注射器；
图2是类似于图1的视图，但是是图1的医疗器械的替代实施方式(为了清楚起见省去了端部执行器的外护套)，包括不同的通道类型路径和不同的超声传播元件；
图3是图1的医疗器械的另一种替代实施方式的端部执行器的示意性剖视图，包括杆型路径和不同的超声传播元件；
图4是本发明的第二种实施方式的剖视图的侧视图，其中医疗系统包括超声外科剪，并包括适于将止血剂喷洒到患者组织上的弥雾机；和
图5是图4的超声外科剪和止血剂的透视图，所述止血剂包括具有凝块的套筒并适于载于超声外科剪的插脚上。
具体实施方式
在详细解释本发明之前，应当理解的是，本发明不限于在附图和说明书中示出和阐述的部件的构造和设置的细节的应用或使用。所示的本发明的实施方式可以以其它实施方式、变化和修改来实现或者包含，并可以各种方式实践或者实现。此外，除非特别指明，为方便读者，在本文中使用的术语和表达方式为描述本发明的典型实施方式的目的而选择，而不是出于限制本发明的目的。
应理解，任何一个或多个下述实施方式、例子等可与任何一个或多个其它下述实施方式、例子等结合。
现在参见附图，其中相同的附图标记表示相同的元件，图1示出了本发明的第一种实施方式。图1的实施方式的第一种表达方式是医疗器械10，包括医疗端部执行器12和用户致动的介质输送器14。医疗端部执行器12包括超声传播元件16并包括当沿着其输送时适于将药剂20定向到超声传播元件16的路径18。用户致动介质输送器14适于沿着路径18输送药剂20并与超声传播元件16接触。
在图1的实施方式的第一种表达方式的一种实现方式中，当沿着路径18输送(没有受到超声振动)时药剂20具有更粘性的状态(包括但不限于固体状态和固/液混合状态，例如粘液载体中的粒子或者固体聚合物载体中稳定的微泡)，并且当由超声传播元件16超声振动时具有较小的粘性状态。在一种使用方式中，实现了药剂20的改进扩散，当其不再受到超声传播元件16的超声振动时扩散的药剂恢复到更粘性的状态，停留在原位。
超声传播元件16是适于以超声频率振动的元件。在一种利用中，超声传播元件16适于以20千赫到500千赫范围内的频率振动。在一个例子中，超声传播元件16具有最远侧振动波腹22，并且介质输送器14适于沿着路径18输送药剂20并与超声传播元件16在其最远侧振动波腹22处或附近的区域接触。在一种应用中，超声传播元件16是弯曲的超声刀。超声传播元件16将热能输送到药剂20。这种能量输送可迅速发生到药剂20并可极为靠近接触区域(也就是说，能量沉积可以陡的热梯度为特征)，从而为药剂20提供能量输送控制。使用这种受控能量输送，药剂20可以受控的方式被输送；用户可快速连续地开始和停止药剂20的输送。
药剂的例子包括但不限于对患者组织具有疗效的治疗剂，和当使用医学成像装置观察手术部位时(例如需要标记手术部位和识别诊断边界时)改善药剂和相邻组织的可视性的成像增强剂。医学成像装置的例子包括但不限于诊断超声装置、磁共振成像装置、计算机层析成像装置以及射线照相装置。组织成像增强剂的例子包括但不限于放射性同位素，射线照相染料，微泡，铁粒子，钆螯合物，锰螯合物等等。在一种应用中，治疗剂具有医学活性部分和医学非活性部分，其中所述医学非活性部分选择为当沿着路径输送时使药剂具有更粘的状态，当由超声传播元件振动时使其具有粘性较小的状态。一旦处于位置中，使药剂冷却，直到其达到与周围组织的热平衡，从而使药剂恢复到更粘的状态(例如但不限于固体状态)。药剂和邻近组织的成像借助至少下列之一来改进：a)前述增强剂存在与药剂的不活动部分或者组织的误配的和可分辨的边界，上面列举的成像模式是已知的解决方法；和b)冷却的药剂本身存在与相邻组织的误配的和可分辨的边界，同样，上面列举的成像模式是已知的解决方法。
治疗剂的例子包括但不限于聚合物、胶合剂、接合剂和药物，它们单独或作为组合试剂提供临床效果，诸如具有促凝血(procoagulative)(借助压塞或者化学诱导，诸如通过凝集促进)、细胞死亡、生长抑制、细胞生长/移植、消融、膨胀、感染抑制、痛苦减轻和/或靠近(例如通过粘性粘接)效果。在一种变化中，治疗剂包括在一段时间后可被患者组织吸收的生物可降解材料。这种生物可降解试剂可以是固体聚合物或者粘性流体，并可包括结合药物、基因治疗或者对于局部吸收而言(相对于粘性较小的状态下单独输送而言)通过延长的期限(time frame)提供受控的或者长的持续临床效果的活生物体。在相同或不同的变型中，治疗剂包括使结构(诸如装置、植入物或者患者组织)接近或者连接的粘接材料。在相同或不同变型中，治疗剂具有医学活性状态和医学非活性状态，其中通过外部工具(诸如超声压力波或者光)使药剂具有医学活性。
在图1的实施方式的第一种表现方式的实现方式中，路径18包括通道24，并且用户致动的介质输送器14适于在通道24中传输药剂20。在相同或不同实现方式中，当沿着路径8输送(没有受到超声振动)时药剂20具有更粘的流体状态，当由超声传播元件16超声振动时具有较小粘性的流体状态。在一种变化中，路径18包括通道24，用户致动的介质输送器14包括注射器26。在一个例子中，医疗端部执行器12包括外护套28，通道24是外护套28的腔，超声传播元件16从外护套28延伸或者可从其伸出，医疗器械10包括手持件30，并且手持件30和注射器26与外护套28连接。
超声传播元件的其它形状(未显示)包括：那些具有孔的形状，当所述孔接触围绕孔的壁时药剂20可穿过其中；那些具有分开式元件(一个向上弯曲，另一个向下弯曲)和两个路径(一个将第一药剂引向向上弯曲的元件，另一个将第二药剂引向向下弯曲的元件)的形状；那些具有单个元件并具有上端销和下端销和两个路径(一个将药剂引向上端销，另一个将药剂引向下端销)的形状；以及那些其超声传播元件靠近由外部管携带的远端针的形状，所述外部管的侧壁被切除以暴露出元件。
医疗器械110的第一种替代实施方式在图2中显示。在一种实现方式中，当沿着路径118输送时药剂120具有固体状态(或者固液混合态，诸如液体载体中的粒子)，当由超声传播元件116超声振动时具有液体状态。在一种变型中，用户致动的介质输送器114包括沿着装置延伸以便向远侧促动药剂120并与超声传播元件116接触的推动滑块126。如图2所示，推动滑块126通过滑动或者平移将来自用户的力传递给介质。类似地，轴向力和/或旋转扭矩可通过例如导螺杆被提供给药剂120。在一种变型中，超声传播元件116具有针形并与通道124同轴对准。在一个例子中，在受到超声振动之前，药剂120包括一系列固体药剂，每种都具有球形形状。固体药剂的形状的其它例子(未显示)包括但不限于一系列具有平末端的圆柱体和一系列具有球窝末端的圆柱体。在一种构造中，通道124是内护套132的通道，所述内护套132可在振动节点处例如借助肋、O形环等与超声传播元件116在振动上隔离。
医疗器械210的第二种替代实施方式在图3中显示。在一种实现方式中，路径218包括管状的杆224，药剂220具有环形形状并适于安放在杆224上。在该实现方式中，用户致动的介质输送器(未显示，但在一种例子中是环形推动滑块，其余与图2中显示的推动滑块126相同，在另一个例子中是向药剂220施加平移和/或旋转的导螺杆)适于沿着杆224输送药剂220，并与超声传播元件216的远端(例如球形或针形远端)接触。在一个例子中，在受到超声振动之前，药剂220包括一系列固体药剂，每个具有环形形状。其它环形形状的例子(未显示)包括但不限于一系列管。在一种构造中，杆224是内护套杆，其围绕超声传播元件216并可在振动节点处例如借助肋、O形环等与超声传播元件216连接，从而使结构支撑件对超声传播元件216的性能的冲击最小(即，杆224与超声传播元件216在振动上隔离)。
使用图1的实施方式的第一种表达方式的医疗器械10对患者组织进行医学处理的方法(其中当超声振动时药剂20的粘度变小)包括步骤a)到d)。步骤a)包括将医疗端部执行器12设置到待进行医学处理的患者组织附近。步骤b)包括使用用户致动介质输送器14以沿着路径18输送处于更粘状态(例如但不限于固体状态)的药剂20并与超声传播元件16接触。步骤c)包括致动超声传播元件16使药剂20热变化到粘度较小的状态，以扩散药剂20。步骤d)包括使超声传播元件16解除致动，从而使扩散的药剂20热恢复到更粘的状态(例如但不限于固体状态)。
在一种使用中，药剂20具有至少一种选自如下组中的效果，所述效果包括组织标记、组织部位成像增强、借助压塞凝结、借助化学诱导的凝集促进凝结、细胞死亡、组织生长抑制、组织消融、组织膨胀、感染抑制、痛苦减轻、细胞生长/移植、组织靠近、装置靠近以及植入物靠近。在相同或不同使用中，用户致动介质输送器包括导螺杆。在相同或不同使用中，还包括使用涂层材料涂覆药剂20以降低药剂20对超声传播元件16的粘接。涂层材料的例子包括但不限于特氟隆(Teflon)悬浮液，Paralene(商标名)，MDX(硅树脂扩散液)和氮化钛。
再次参见附图，图4-5示出了本发明的第二种实施方式。图4-5的实施方式的第一种表达方式是医疗系统310，包括医疗器械312和用户致动止血剂传输器314。需要注意的是，术语“用户”包括但不限于人类用户和机器人用户。医疗器械312适于处理患者组织316并选自包括基于机械的结扎器械和基于能量的结扎器械318的组。用户致动止血剂输送器314适于将止血剂320输送到患者组织316。
在图4-5的实施方式的第一种表达方式的一种实现方式中，患者组织316包括血管322。在一种变型中，医疗器械312是适于横切血管322的基于能量的结扎器械318。在一种改变中，基于能量的结扎器械318包括超声外科剪324。基于能量的结扎器械的其它例子包括但不限于双极血管闭合器。基于机械的结扎器械的例子包括但不限于夹具施放器和组织缝合器。止血剂320的例子包括但不限于粘接剂，诸如胶水(例如丙烯酸氰基酯(cynoacrylites))，粘合剂，诸如环氧树脂类(例如氨基甲酸乙酯)等。
在图4-5的实施方式的第一种表达方式的一种应用中，用户致动止血剂传输器314包括适于将止血剂320喷洒到患者组织316上的弥雾机326。其它用户致动止血剂输送器包括但不限于前述介质传输器14。
在图4-5的实施方式的第一种表达方式的一种实现方式中，当由能量致动时，止血剂320具有止血特性，并且医疗器械312是适于活化止血剂320的止血特性的基于能量的结扎器械318。在一种变化中，止血剂320包括适于利用来自基于能量的结扎器械318的能量被变性形成凝集的蛋白质。
本发明的方法用于封闭患者的血管322。所述方法包括将止血剂320应用到血管322。所述方法包括使用医疗器械312处理血管322，所述医疗器械312选自包括基于机械的结扎器械和基于能量的结扎器械318的组。
在所述方法的一种实现方式中，医疗器械312是基于能量的结扎器械318，并且基于能量的结扎器械318选自包括超声外科剪324和双极血管闭合器的组。在一种变化中，止血剂320包括适于由来自基于能量的结扎器械318的能量变性形成凝集的蛋白质。在相同或不同变化中，基于能量的结扎器械318是具有插脚328(超声外科剪324的超声刀330或者夹钳臂332)的超声外科剪324，并且止血剂320包括套筒334(例如止血剂具有环形形状)，所述套筒334包括凝结物并适于携带于插脚328(在图5中显示两个套筒330和两个插脚328)上。在所述方法的不同实现方式中，医疗器械312是基于机械的结扎器械，基于机械的结扎器械选自包括夹具施放器和缝合器的组。
通过本发明的一种或多种方法和实施方式得到了许多益处和优点。在一个例子中，当沿着路径借助机械平移、机械旋转、机械平移并旋转、流体压力差等等输送(没有受到超声振动)时，药剂具有更粘稠状态，并且当由超声传播元件超声振动时具有较小的粘稠状态，所述超声传播元件允许药剂的改进扩散。在另一个例子中，将止血剂输送到患者组织(诸如将止血剂应用到血管)能够当使用基于机械或者基于能量的结扎器械对患者组织(诸如血管)进行处理时促进止血。
虽然已经通过一些实施方式和方法的描述对本发明进行了解释，申请人并不是想将所附的权利要求书的精神和范围限制或限定得如此详细。在不背离本发明的精神的情况下的许多其它变化、改变和替代对本领域技术人员来说都是可以想到的。例如，考虑到所述系统、元件和方法与所述机械系统兼容的明显修改，本发明的医疗器械和医疗系统在机器辅助的外科方面具有应用。应当理解，前述描述仅仅作为例子提供，本领域技术人员在不背离所附的权利要求书的精神和范围的情况下可进行其它修改。

Claims (9)

1、一种医疗器械，包括：
a)医疗端部执行器，包括超声传播元件并包括当沿着其输送时适于将药剂定向到超声传播元件的路径；以及
b)用户致动介质输送器，适于沿着所述路径输送所述药剂并使所述药剂与所述超声传播元件接触。
2、根据权利要求1所述的医疗器械，还包括药剂，其中当沿着所述路径输送时，所述药剂具有更粘稠状态，并且当由所述超声传播元件超声振动时，所述药剂具有较小的粘稠状态。
3、根据权利要求2所述的医疗器械，其中，当沿着所述路径输送时，所述药剂具有更粘稠的液态，并且当由所述超声传播元件超声振动时，所述药剂具有较小粘稠的液态。
4、根据权利要求3所述的医疗器械，其中，所述路径包括通道，其中所述用户致动介质传输器包括注射器。
5、根据权利要求2所述的医疗器械，其中，当沿着所述路径输送时所述药剂处于固态，当由所述超声传播元件超声振动时所述药剂处于液态。
6、根据权利要求5所述的医疗器械，其中，所述用户致动介质输送器包括推动滑块。
7、根据权利要求2所述的医疗器械，其中，所述超声传播元件适于以范围在20千赫到500千赫范围内的频率振动。
8、根据权利要求2所述的医疗器械，其中，所述路径包括通道，并且其中所述用户致动介质输送器适于在通道中输送药剂。
9、根据权利要求2所述的医疗器械，其中，所述路径包括管形的杆，其中所述药剂具有环形形状并适于安放在所述杆上，其中所述用户致动介质输送器适于沿着所述杆输送所述药剂。
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AU2007200414A1 (en) 2007-08-30
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CA2578485A1 (en) 2007-08-15
EP1820459A3 (en) 2007-09-19
JP5160101B2 (ja) 2013-03-13
US20070191712A1 (en) 2007-08-16

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