CN101484203B - 排气压力操作型气囊导管系统 - Google Patents

排气压力操作型气囊导管系统 Download PDF

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CN101484203B
CN101484203B CN200680052240XA CN200680052240A CN101484203B CN 101484203 B CN101484203 B CN 101484203B CN 200680052240X A CN200680052240X A CN 200680052240XA CN 200680052240 A CN200680052240 A CN 200680052240A CN 101484203 B CN101484203 B CN 101484203B
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conduit
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CN101484203A (zh
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M·J·波内特
E·J·索尔
D·J·鲍尔
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3203—Fluid jet cutting instruments
    • A61B17/32037—Fluid jet cutting instruments for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10181—Means for forcing inflation fluid into the balloon
    • A61M25/10182—Injector syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation

Abstract

一种排气压力操作型气囊导管系统是横向流的血栓切除术导管，例如，但不局限于，带有柔性和可膨胀气囊的Angiojet
Figure B200680052240XA00011
导管，其中，气囊由导管形成并与导管相连续，导管部分地形成横向流血栓切除术导管，其中，气囊围绕横向流血栓切除术导管远端区域展开和膨胀以起作闭塞装置，其中，气囊位于流体射流发射器和切除横向流上游的流入孔和流出孔的近端。通过操作由排气压力操作型气囊导管系统的流体射流产生的横向流，形成排气压力或背压，使气囊膨胀地展开。

Description

排气压力操作型气囊导管系统
相关申请
本专利申请涉及2003年6月5日提交的申请No.10/455,096，其题为“Thrombectomy Catheter Device Having a Self-Sealing Hemostasic Valve(具有自封口功能止血阀的血栓切除术导管装置)”，该申请待审查。
技术领域
本发明涉及一种血栓切除术导管，具体来说，本发明涉及一种排气压力操作型气囊导管系统，该系统是横向流血栓切除术导管，例如，但不局限于，带有柔性和可膨胀气囊的安久捷特(Angiojet)
Figure S200680052240XD00011
导管，其中，气囊可围绕横向流血栓切除术导管的远端区域展开和膨胀，其中，气囊在流体射流发射器和切除横向流上游的流入和流出孔的近端。操作排气压力操作型气囊导管系统的流体射流所产生的横向流，产生排气或背压，使气囊膨胀地展开。
背景技术
现有技术的血栓切除术导管系统包括歧管和导管，导管具有多个涉及切除射流的流入和流出孔，所述射流与膨胀闭塞的气囊相合作。该闭塞气囊在极大程度上需要对其与导管的附连作出精细的方案，所述导管用作为带走切除过程存在的颗粒和其它流体的排气管。气囊通常对准和围绕导管/排气管，然后，用粘结剂、电子粘结等方法固定到导管。常常还需要单独的包括充气孔的充气腔，以便与闭塞气囊连通和对其充气；或依赖于需要使用可移动部件的复杂方案，在血栓切除术过程中膨胀闭塞的气囊。也可使用其它膨胀方法。
发明内容
本发明总目的是提供一种排气压力操作型气囊导管系统以在血管中精致地阻塞血流。血流的停止使Angiojet
Figure S200680052240XD00012
型血栓切除术导管装置和一些手术的效率得到优化，手术包括药物灌输、包围栓塞、血栓切除术的手术和其它的手术，由于可供溶解的血量减到最小，所以，减小了溶血。本发明利用位于近端的带有Angiojet
Figure S200680052240XD00021
血栓切除术导管装置的气囊，其涉及横向流的切除流动，具体来说，本发明利用形成在Angiojet
Figure S200680052240XD00022
血栓切除术导管装置的导管(排气管)之外的充气气囊，所述Angiojet
Figure S200680052240XD00023
血栓切除术导管装置相对于横向流位于近端，操作由血栓切除术导管的流体射流产生的横向流，并使用由此形成的背压来展开Angiojet
Figure S200680052240XD00024
血栓切除术导管装置。尽管过去已经提出将气囊附连在流入和流出孔近端或远端的导管上，但本发明则更进一步，其形成包括佩巴科斯(Pebax)、聚亚安酯或其它合适材料制成的导管(排气管)结构的气囊，同时使用流体射流的排气压力来填充气囊和维持气囊的膨胀，目的在于近端保护或闭塞，在用于逆向流动的某些情形中，则是远端的保护。该结构最大程度地减小总体外形、部件数量和设计复杂性、制造成本，并提供一种排气压力操作型气囊导管系统，由于排气压力操作型气囊导管系统被致动时，气囊是自动地展开的，所以该系统使用非常容易。
由于Angiojet
Figure S200680052240XD00025
型血栓切除术导管更有效地除去停滞流中的碎片，以及在具有停滞流的其它手术中更加有效，所以，本发明在好几种应用中很有效。本发明可与过滤器合作使用，以便更有效地从过滤器内和过滤器周围除去碎片。可使用本发明来提高从特殊血管长度中除去的碎片/血栓量。据此，本发明还可将远端或近端的栓塞减到最少。本发明可用来更有效地将药物提供到一停滞的区域。气囊也可用来将导管对中或定位在血管中。最后，当气囊导管移动通过阻塞的血管时，本发明可用来破碎凝块(修正的栓子切除术)。
根据本发明的一个或多个实施例中，提供一种包括歧管和紧密相关的部件的排气压力操作型气囊导管系统，该系统包括止血螺母组件；自封口的止血阀；螺纹的高压连接端口；通过应变释放结构连接地从歧管延伸的导管(有时称之为排气管)；具有多个紧靠的延伸通过导管侧壁的流出孔和流入孔的导管锥形末端；从螺纹的高压连接端口通过歧管和通过导管延伸到位于多个流出孔和流入孔远端的流体射流发射器的连接的高压管；沿着高压管远端部分间距开并固定到高压管远端部分的第一组支承环；支承环和上述流体射流发射器沿着高压管远端部分间距开并固定到高压管远端部分；对准在全厚度导管部分之间的导管薄壁部分(这里称之为气囊)，其中，全厚度导管部分对准，以及沿与第一组间距的支承环相反方向延伸；固定在导管上和导管周围与下面第一组支承环对准的辐射透不过的标记带；以及紧靠多个流出孔和流入孔的导管一部分，其中，这样一部分导管对准在间距开的支承环和上述流体射流发射器上和其周围，并用辐射透不过的标记带固定在其上和其周围。
本发明排气压力操作型气囊导管系统的一显著方面和特征是，使用近端地位于Angiojet型血栓切除术导管上的气囊(下文中称为近端气囊)，其中，气囊有减小的壁厚并由导管(排气管)本身形成。
排气压力操作型气囊导管系统的另一显著方面和特征是，位于Angiojet血栓切除术导管上的近端气囊，它通过操作排气压力操作型气囊导管系统所产生的背压来展开。
排气压力操作型气囊导管系统的另一显著方面和特征是，位于Angiojet
Figure S200680052240XD00033
血栓切除术导管上的近端气囊，它用下面的支承环或通过其它合适方法固定和定位在两个标记带之间。
排气压力操作型气囊导管系统的另一显著方面和特征是，位于Angiojet
Figure S200680052240XD00034
血栓切除术导管上的近端气囊，它的目的是停止血管或其它体内导管内流体的流动。
排气压力操作型气囊导管系统的另一显著方面和特征是，位于Angiojet
Figure S200680052240XD00035
血栓切除术导管上的近端气囊，它的目的是停止血管或其它体内导管内流体的流动，以使血栓切除术导管在碎片或组织去除方面达到最大的效果。
排气压力操作型气囊导管系统的另一显著方面和特征是，位于Angiojet
Figure S200680052240XD00036
血栓切除术导管上的近端气囊，它的目的是停止血管或其它体内导管内流体的流动，以使血栓切除术导管在从远端保护过滤器丝网或气囊中除去碎片或组织方面达到最大的效果。
排气压力操作型气囊导管系统的另一显著方面和特征是，位于Angiojet
Figure S200680052240XD00037
血栓切除术导管上的近端气囊，它的目的是对中导管。
排气压力操作型气囊导管系统的另一显著方面和特征是，位于Angiojet
Figure S200680052240XD00038
血栓切除术导管上的近端气囊，它的目的是修正栓子切除术。
排气压力操作型气囊导管系统的另一显著方面和特征是，用来将药物供应到血管或其它体内导管。
由此，简明地描述了本发明的实施例并提及了本发明某些显著的方面和特征，本发明的主要目的是提供一种排气压力操作型气囊导管系统。
附图说明
参照以下结合附图的详细描述，将可容易地认识并可更好地理解本发明其它的目的和本发明许多相随的优点，在全部的附图中，相同的标号表示相同的零件，其中：
图1是示出本发明排气压力操作型气囊导管系统可见部件的平面图，显示本发明主要特征、部件或组件；
图2是排气压力操作型气囊导管系统的分解立体图；
图3显示图4a、4b和4c的对准关系；
图4a、4b和4c一起示出排气压力操作型气囊导管系统的不同比例部件的截面图，它们沿图1的线4a-4a、4b-4b和4c-4c截取得到；
图5示出连接到辅助装置的本发明；以及
图6示出执行本发明使用方法的排气压力操作型气囊导管系统。
具体实施方式
图1是一平面图，显示本发明的排气压力操作型气囊导管系统10的可见部件，示出了本发明的主要特征、部件或组件。本发明如此的主要特征、部件或组件包括具有导管14的一件式歧管12，所述导管14从歧管12延伸并附连在歧管上，现将描述其所包括的细节。一柔性可膨胀和充气的气囊(本文中称其为气囊16)显示为充气的位置中，其为导管14的一体部分，导管14可称之为排气管。气囊16位于靠近导管14的远端，刚好靠近沿着和围绕导管14远端的多个流入孔18a-18n和多个流出孔20a-20n。气囊16的膨胀外形用虚线显示为膨胀的气囊16a。一件式歧管12的可见部分包括：中心管状体24；高压连接支管26，该高压连接支管26包括一体的螺纹连接器端口28(图2)且从中心管状体24斜向延伸出来；排气支管30，该排气支管30包括一体的螺纹连接器端口32且从高压连接支管26斜向延伸出来；以及腔体34，该腔体34从中心管状体24向近端延伸出来。导管14具有内腔40(图2)，而导管14的近端延伸通过应变释放结构36的内部并密封地抵靠在其上，还延伸通过同心定位的连接器38以使内腔40与歧管12的内部连通。导管14朝向远端延伸以包括锥形末端42，在锥形末端处内腔40的直径减小(见图4c)，其中所有零件都是柔性的。两个相对的辐射透不过的标记带46和48显示位于气囊16两侧处的导管14的周围，而两个相对的辐射透不过的标记带50和52显示位于多个流入孔18a-18n和多个流出孔20a-20n两侧处的导管14的周围。止血螺母组件54对准于腔体34的特征件并贴合地和螺纹地啮合该特征件。螺纹的高压连接端口56合适地固定到与连接器58合作的高压连接支管26的一体螺纹连接器端口28的内部。
图2是本发明的排气压力操作型气囊导管系统10的分解的立体图，图4a、4b和4c的排列关系显示在图3中，该三个图一起图示出排气压力操作型气囊导管系统10的不同比例部件的截面图，其不包括导管14的全长，但包括诸如本发明使用中包含的导向丝60(图4a)。为清晰起见，图4b和4c图示的比例稍大于图4a的比例。导管14也用作和起作排气管的功能，导管14和高压管62为清晰起见而透视缩短和显示为部分长度。
一起参照图2和图4a、4b和4c，进一步描述本发明。歧管12包括多个连接的和连通的通道和内腔，这些通道和内腔包括：高压支管通道64，该高压支管通道64位于高压支管26和一体螺纹连接器端口28内；排气支管通道66，该排气支管通道66位于排气支管30和一体螺纹连接器端口32内且与高压支管通道64相交并连通；以及锥形的中心通道68，该中心通道68从朝向远端的螺纹连接端口70延伸并延伸通过端口70，该端口70与中心管状体24形成一体，并通过中心管状体24到内腔72，与内腔72连通，内腔72较佳地呈圆柱形，位于腔体34的中心。内螺纹74(图4a)位于腔体34内部的周围并靠近歧管12的近端区域以便容纳止血螺母组件54的螺纹端。
本发明的有益之处在于，使用了自封口的止血阀76，其形状和功能在2003年6月5日提交的待审查的专利申请No.10/455,096中有详细的描述，其题为“Thrombectomy Catheter Device Having a Self-Sealing Hemostasic Valve”。自封口的止血阀76在歧管12的近端区域处被对准、擒获并容纳在腔72的远端部分内。腔72呈管状而包括管状的内腔壁78、螺纹74和呈环形和圆形的相交平表面80。位于平表面80中心的孔82是内腔72和锥形中心通道68所共有。止血螺母组件54包括通道86，其延伸通过总的本体并通过具有外螺纹88的圆柱形凸台84。一体的致动器钮90也是止血螺母组件54的一部分。歧管12的近端利用内螺纹74将止血螺母组件54附连到歧管12，那里，止血螺母组件54的外螺纹88转动地啮合歧管12的内螺纹74，以使圆柱形凸台84抵靠在自封口的止血阀76上，由此，导致自封口的止血阀76密封住导向丝60并密封住锥形中心通道68的近端，在本发明的静态或致动状态中，如此的密封在该处是很有效的。包括在止血螺母组件54内的还有环形唇边92，图2清晰地示出该环形唇边92，多个凹坑94从腔体34的管状腔壁78中向内突出(图2)，环形唇边92用来与凹坑94贴合地配合。
图中还示出套圈96，其对准在高压连接端口56的通道98内，它们的组合对准在螺纹连接器端口28处的高压支管通道64的一部分之内。高压管62的近端被用来接纳高压切除的液体，并合适地固定在套圈96的中心通道内以与螺纹的高压连接端口56的通道98连通。高压管62还延伸通过高压支管通道64、通过锥形中心通道68的部分、通过包括导管14内的内腔40、连接器38和应变释放结构36在内的同轴对准部件，因此，通过平衡导管14中内腔40的长度来附连到其它的现将描述的部件。高压管62延伸通过支承环100、102和104，延伸到末端42，那里，设置高压管62的终端，其呈流体射流发射器106的形式，其在其它的申请和受让于受让者的专利中有描述。高压管62还延伸通过辐射透不过的标记带46、48和50，延伸到流体射流发射器106和辐射透不过的标记带52。高压管62例如通过焊接和其它合适的方法较佳地附连到支承环100、102和104和流体射流发射器106，那里，支承环100、102和104和流体射流发射器106对辐射透不过的标记带46、48、50和52下方区域内的导管14起作协同定位的支承功能。在图2中，辐射透不过的标记带46、48、50和52为清晰起见显示为从支承环100、102和104和流体射流发射器106朝向远端位移一短距离，它们在沿着和围绕图4b和4c中的导管14的远端部分的实际位置中显示为摩擦的配合。
辐射透不过的标记带46、48、50和52和支承环100、102和104和流体射流发射器106彼此和导管14之间的关系清晰地显示在图4b和4c中。在图4b中，气囊16显示为与导管14连续，其中，与导管14总的壁厚相比，气囊16的壁厚减小。气囊16的壁厚是合适的壁厚，以允许对气囊16充气而膨胀以相遇和密封抵靠在可发生血栓切除术、提供药物和其它手术的脉管的管壁上。辐射透不过的标记带46和48和支承环100和102显示为强制地接触邻近于气囊16的导管14的全壁厚，由此，允许气囊16较薄壁的全长用来进行膨胀。或者，气囊16的一合适部分也可配合在辐射透不过的标记带46和48与支承环100和102之间。气囊16的膨胀用虚线显示为膨胀的气囊16a。
图4c示出辐射透不过的标记带50和52围绕导管14远端部分的定位。位于远端的辐射透不过的标记带52被强制施加在导管14的远端部分的周围，以使导管14一部分与流体射流发射器106的环形槽108的全部或部分摩擦地环向配合。如此的摩擦配合足以将辐射透不过的标记带52(还有46、48和50)的外半径表面放置在某一小于导管14总体的且较大的外径向表面的位置，由此，部分地提供没有突出超过导管总体外径向表面的元件的导管14，以使导管14在静脉、动脉等脉管内有无阻碍和光滑的远端或近端的过渡。通道109显示位于流体发射器106的中心，以容纳导向丝的通过。
提供一结构，其自然地帮助导管14的远端部分引入和通过血管、动脉等到达血栓沉淀物或病理部分的部位。在沿远端方向插入移动过程中，相对于圆形和非锥形末端，呈锥形的术端42可以部分地和更容易地穿透血栓沉淀物或病理部分，而不是朝向远端地挺进或推进如此的血栓沉淀物或病理部分。锥形末端42沿远端方向直径的减小还能提高其越过和通过曲折路径的灵活性。
排气管支承环100和102在包围气囊16相对端的区域内与辐射透不过的标记带46和48一起使用，它们是沿导管14在包围气囊16端部区域内提供支承或加强的结构实例。排气管支承环104和流体射流发射器106与辐射透不过的标记带50和52一起使用，是沿导管14提供支承或加强的结构的另一个实例。如此的支承允许导管14使用较薄壁的尺寸，而允许内腔40有较大和更有效和实效的尺寸，以及有利于其它直径减小尺寸。当导管14沿着静脉或血管推进或挺进时，如此的支承还有利于支持地维持导管14直径大小和总体形状，以及有利于扭转的支承。
操作模式
一般来说，普通的导向丝在需治疗的血管中展开，或者，可使用过滤器导向丝或气囊闭塞导向丝。在其它必要的干预手术之后，排气压力操作型气囊导管系统10在导向丝上前进，以除去碎片/血栓、药物灌输或其它手术，以及操纵到合适的位置内以作治疗。可必要地包括导向导管或护套来提供帮助，将排气压力操作型气囊导管系统10的导管14放置在脉管要求的部位内。致动排气压力操作型气囊导管系统10，其中，气囊16自动地和膨胀地展开，形成膨胀的气囊16a并除去碎片或灌输药物。气囊16可交替地加压和减压，其中，在手术过程中，排气压力操作型气囊导管系统10可向近端或向远端移动，以使系统的收效最大。当手术完成时，气囊16一般地放气到足以低于正常动脉血压以便安全地除去，或用手工将注射器附连到排出管线来帮助放气，或通过使用滚子泵来帮助放气。此外，对于其余的导向丝或丝装置通常可执行其它的干预。
具体来说，图5和6示出操作的模式，其中，图5示出连接至辅助装置的本发明，而图6示出执行本发明方法的排气压力操作型气囊导管系统10的远端部分。最好参照图5和6连同上述的附图一起来理解该操作模式。
排气压力操作型气囊导管系统10显示为配合在导向丝60周围，其中导向丝60(先前配合到静脉或动脉内)首先可滑动地配合锥形末端42处的导向丝管道14的内腔40，其后，可滑动地配合流体射流发射器106的通道109，可滑动地配合锥形的中心通道68，并可滑动地和密封地配合止血阀76，以从止血螺母组件54中退出。高压流体源110和高压流体泵112通过螺纹的高压连接端口56和连接器113连接到歧管12。诸如滚子泵和其它合适装置的排气调节器114和收集腔窒116通过如图所示的连接器117连接到排气支管30的螺纹连接器端口32。
图6示出执行本发明方法的排气压力操作型气囊导管系统10，特别地关注排气管14的远端部分，其包括定位在血栓沉淀物或病理部分120部位处的血管118、动脉等中的柔性锥形末端42，那里，血管118和主血栓沉淀物或病理部分120显示在截面图中。多个盐水(或其它合适流体)的高速射流122的喷射流，沿近端方向从流体射流发射器106喷射出而撞击到血栓沉淀物或病理部分120，并带走已被减小为颗粒形式的血栓沉淀物或病理部分。或者，作为该图中所示流体射流发射器106的替代方案，不同结构的其它流体射流发射器也可包括在导管14的远端部分内，以便向近端沿着或靠近导管14的纵向轴线发射或射出一个或多个高速射流122，从而完成与如上描述的流体射流发射器106相同的目的。盐水的高速射流122向外通过流出孔20a-20n沿径向方向流过，形成朝向血管118壁的向外的横向流124，并在流入孔18a-18n处受低压的影响而造成横向流124，以便向远端和圆周地流动而发生撞击、提供曳力和粉碎血栓沉淀物或病理部分120，用夹带方式推动和通过流入孔18a-18n(相对低的压力区域)带走血栓沉淀物或病理部分120的颗粒，流入到高速射流122内，那里，血栓120进一步分离为微小颗粒，由此流入导管腔40内而通过膨胀的气囊16a，并进一步通过内腔40以作其后的排气。流出的排气流被由高速射流122和通过流入孔18a-18n的夹带流体产生的内压所驱动，致使内腔40和气囊16加压，该流出的排气流用作为好几个优点。其一个优点在于，当血的远端由于干预的充气和膨胀的气囊16a的充气而停止流动时，其处于没有流动的情况下，血栓沉淀物或病理部分120的颗粒基本上被滞留，因此可以更加有效地循环、再循环和再稀释，直到所有剩余物是盐水和血栓沉淀物或病理部分120的细小颗粒，其后，通过促使流动通过排气调节器114，沿着近端方向通过导管14的内腔40除去它们。另一优点是使用排气流出流和由高速射流122形成的内压，组合了诸如受排气调节器114影响的对流出流的约束，而造成气囊16自动地膨胀，气囊16强制地撞击和密封抵靠在血管118的内壁上。减小的包括气囊16在内的材料厚度允许气囊16充分地膨胀而变为膨胀的气囊16a，其受到与血管118壁碰撞的限制。可通过在高压流体泵112处控制输入压力的流体和控制排气调节器114处的排气率，来影响充气压力和流动。本发明揭示了排气压力操作型气囊导管系统10，其利用连续形成的充气和膨胀的由与导管(排气管)相同的材料形成的气囊的原理，通过高速射流、横向流等造成的内部加压来自动地进行充气。这样的概念也可应用于其它的血栓切除术导管和系统，诸如，但不局限于，包括快速互换的导管、通过导向丝的导管，以及由流体流源进行加压的导管在内的所有AngioJet
Figure S200680052240XD00091
导管。
零件清单
10排气压力操作型气囊导管系统
12歧管
14导管
16气囊
16a膨胀的气囊
18a-n流入孔
20a-n流出孔
24中心管状体
26高压支管
28螺纹连接器端口
30排气支管
32螺纹连接器端口
34内腔体
36应变释放结构
38连接器
40内腔
42锥形末端
46辐射透不过的标记带
48辐射透不过的标记带
50辐射透不过的标记带
52辐射透不过的标记带
54止血螺母组件
56螺纹的高压连接端口
58连接器
60导向丝
62高压管
64高压支管通道
66排气支管通道
68锥形中心通道
70螺纹连接端口
72内腔
74内螺纹
76自封口止血阀
78管状腔壁
80平表面
82孔
84凸台
86通道
88外螺纹
90致动器钮
92环形唇边
94凹坑
96套圈
98通道
100支承环
102支承环
104支承环
106流体射流发射器
108环形槽
109通道
110高压流体源
112高压流体泵
113连接器
114排气调节器
116收集腔
117连接器
118血管
120血栓沉淀物或病理部分
122高速射流
124横向流
本发明可作出各种修改而不脱离本发明的范围。

Claims (7)

1.一种用于血管中的血栓切除术的排气压力操作型气囊导管系统，包括：
a.一件式歧管，所述一件式歧管包括：
(1)中心管状体；
(2)高压支管，所述高压支管包括一体的螺纹连接器端口，且所述高压支管从所述中心管状体斜向地延伸；
(3)排气支管，所述排气支管包括一体的螺纹连接器端口，且所述排气支管从所述高压支管斜向地延伸；以及
(4)腔体，所述腔体具有止血螺母组件，且所述腔体从所述中心管状体向近端延伸；
b.由第一材料形成的导管，所述导管包括排气内腔，所述导管从所述歧管向远端延伸通过应变释放结构并朝向位于远端的锥形末端；
c.多个在所述导管上与所述排气内腔连通的、紧靠所述锥形末端的流出孔和流入孔；
d.高压管，所述高压管从所述高压支管连接地延伸通过所述歧管和通过所述导管，延伸到位于所述多个流出孔和流入孔远端的流体射流发射器，流体在高压下从所述歧管朝向远端载送到所述流体射流发射器；
e.由所述导管的所述第一材料形成的柔性、可膨胀和可充气的薄壁部分的气囊，所述气囊与壁厚大于所述气囊壁厚的所述导管形成一体，并连接在所述导管的两个部分之间且与这两个部分对准，且在所述多个流出孔和流入孔的近端处，其中所述多个流出孔和流入孔位于所述流体射流发射器和所述薄壁部分的气囊之间，并且多个流出孔和流入孔通过所述排气内腔与所述薄壁部分的气囊和所述流体射流发射器连通；以及
f.所述导管的所述排气内腔与所述薄壁部分的气囊连通，所述导管的所述排气内腔和所述薄壁部分的气囊由来自所述流体射流发射器的朝向近端的排气流和通过所述多个流出孔流出并以夹带流形式从所述流入孔流入的流体可维持地加压，且所述朝向近端的排气流将所述薄壁部分的气囊充气到膨胀状态。
2.如权利要求1所述的排气压力操作型气囊导管系统，其特征在于，还包括位于所述薄壁部分的气囊远端和近端的相对的辐射透不过的标记带。
3.如权利要求2所述的排气压力操作型气囊导管系统，其特征在于，还包括与所述薄壁部分的气囊相邻的支承环。
4.如权利要求1所述的排气压力操作型气囊导管系统，其特征在于，所述止血螺母组件卡合地和螺纹地配合所述腔体。
5.如权利要求4所述的排气压力操作型气囊导管系统，其特征在于，所述腔体包括所述腔体上向内突出的凹坑，用于与所述止血螺母组件上的环形唇边配合。
6.如权利要求1所述的排气压力操作型气囊导管系统，其特征在于，所述薄壁部分的气囊可围绕所述导管远端区域展开和膨胀，以在与所述排气压力操作型气囊导管系统连接的排气压力装置操作时起作闭塞装置。
7.如权利要求1所述的排气压力操作型气囊导管系统，其特征在于，所述流体射流发射器和所述流入孔和所述流出孔限定了由所述流体射流发射器的流体产生的切除用横向流的位置，其中，所述薄壁部分的气囊位于所述切除用横向流的部位的近端。
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EP1959842A2 (en) 2008-08-27
US8162878B2 (en) 2012-04-24
WO2007067661A2 (en) 2007-06-14
WO2007067661A3 (en) 2009-01-15
CN101484203A (zh) 2009-07-15
JP2009518134A (ja) 2009-05-07
US20090149807A1 (en) 2009-06-11

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