CN1997317A - 定位器和传送设备及其使用方法 - Google Patents

定位器和传送设备及其使用方法 Download PDF

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CN1997317A
CN1997317A CNA2005800162749A CN200580016274A CN1997317A CN 1997317 A CN1997317 A CN 1997317A CN A2005800162749 A CNA2005800162749 A CN A2005800162749A CN 200580016274 A CN200580016274 A CN 200580016274A CN 1997317 A CN1997317 A CN 1997317A
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equipment
locking device
elongate member
distal
guide line
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CN100508898C (zh
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R·S·金
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Contis Usa
Kandele Health 529 Co ltd
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Ensure Medical Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/0065Type of implements the implement being an adhesive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/00654Type of implements entirely comprised between the two sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00672Locating means therefor, e.g. bleed back lumen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22038Implements 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 a guide wire
    • A61B2017/22047Means for immobilising the guide wire in the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2051Electromagnetic tracking systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/062Measuring instruments not otherwise provided for penetration depth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0807Indication means
    • A61B2090/0811Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Abstract

本发明涉及用于密封血管穿刺点的装置和方法以及用于正确定位和布置密封设备的装置和方法。定位装置(11)包括内腔(27),该内腔从该装置的远侧区域中的开口(12)伸出而且靠近该密封设备,该内腔延伸到该设备近侧区域中另一开口(13)。当远侧开口连通血管中的血液时,血液流过该内腔并从近侧开口流出意味着对于用户的这一位置。当回撤该密封设备使得进行这样布置该密封设备以便它阻断血液流入远侧时,用户将知道密封设备的位置。接着将密封设备与传送设备分离。

Description

定位器和传送设备及其使用方法
发明领域
本发明通常涉及用于密封或闭合穿过组织的通道的装置和方法,尤其是涉及用于密封穿刺孔或与身体内腔(诸如血管)连通的其它开口,以及涉及传送该设备的装置和方法。
发明背景
通常穿过经患者皮肤和肌肉组织将一中空的针插入到血管系统中来执行导管插入术和介入操作,诸如血管成形术或支架术。接着可将引导线穿过该针的内腔而进入到插有该针的患者血管中。可以去除该针,并且可将导管鞘沿着引导线进入到该血管中,该导管鞘例如是与扩张器一起进入的,或者在扩张器之后进入的。然后,导管或别的设备可穿过导管鞘的内腔并沿着引导线进入到一个位置用以执行医疗操作。这样,导管鞘可方便将各种设备插入到血管中,而将对血管壁的损伤减到最小和/或在操作期间将出血降到最小。
一旦操作结束,可去除该设备和插管器,在血管壁上留下穿刺点。可对该穿刺点施加外部压力直到发生凝固和伤口愈合。然而,这一操作可能是费时且昂贵的,需要医生或护士差不多一小时的时间。对患者也是不舒服的,并且需要患者在手术室、导管室或保持区域内保持固定不动。另外,在止血前有因出血而导致血肿的危险。
已经提出了多种装置用于通过堵塞穿刺点来经皮密封血管穿刺孔。例如,授予Kensey等人的美国专利No.5,192,302和No.5,222,974描述了可通过导管鞘进入到穿刺点的生物降解塞的使用。当布置好该塞后,该塞可密封血管并提供止血。然而,这种设备很难相对于血管恰当地定位,这一点特别重要因为通常不希望将塞子的材料(例如胶原质)暴露在血流中,这种情况下其可顺流漂动并引起栓塞的危险。
已经提出了包括经皮缝合穿刺点的另一技术,诸如在授予Hathaway等人的美国专利No.5,304,184中所描述的。然而,经皮缝合设备将需要用户有显著的技能,机械复杂且很昂贵。
已经提出了卡钉和手术夹来闭合组织上的伤口或其它开口。例如,授予Brown的美国专利No.5,007,921和No.5,026,390公开了可用于闭合伤口或切口的卡钉。在一个实施例中,公开了包括倒钩的“S”形卡钉,该倒钩可以在伤口的两侧上嵌入到组织中。在另一实施例中,公开了环形卡钉,其包括从环上伸出的倒钩。然而,这些卡钉具有较大的截面轮廓,因此不易通过经皮点传送以闭合血管壁上的开口。
授予Lee的美国专利No.6,033,427公开了用于密封内部穿刺点的方法和设备,其在一个实施例中使用双内腔回流系统,其中远侧回流端口沿轴向彼此隔开,使得当闭塞装置位于某一位置时,将会有回流穿过其中一个腔,而不会穿过另一个腔。
另外,已经提议了可旋入皮肤内开口的皮肤密封件。例如,授予Rudd等人的美国专利No.5,645,565公开了可旋入穿刺孔内以密封该穿刺孔的手术塞。该手术塞包括增大的帽和从该帽伸出的螺纹杆。在内窥镜操作中,将塞子通过皮肤旋入开口直到该帽接合皮肤的表面。该塞子用于密封与体腔连通的开口,以防止吹入的流体从体腔中泄漏。然而,这种塞子仅可用在皮肤的表面,并不能引入穿过组织,以便来例如密封血管壁或其它皮下区域中的开口。
已经提议了各种方法和装置用于确定一种闭合设备的远端的位置,包括诸如在授予Magro等人的美国专利No.4,738,658中公开的“回流”方法。然而,已经构建的现有回流设备使得在布置该密封装置期间血液从患者的流出持续了比所希望的更长的时间。
在已公布的美国专利申请2004/0019330中公开了回流技术进一步的发展,其中,具有增大远端的控制元件既用于控制流过血管穿刺孔的血流,又用于通过将该增大远端从血管内腔中回撤到血管壁内的穿刺孔中来提供导管鞘远端的位置的指示,使得根据该公布的申请来阻止回流。
Leschinsky的专利No.5,871,501公开了使用引导线上的锚来提供血管壁位置的指示,以便帮助放置止血材料来阻断血流流出血管上的穿刺孔。
虽然已经提议了这些和其它方法及设备来布置塞子,以阻止血流从血管内的穿刺孔流出,但是仍需要为实现该目的所采用的布置塞子的安全且有效的设备和方法。
发明内容
本发明关注于能够定位被穿刺的血管并密封该血管中的穿刺孔的设备,以及使用该设备的方法。该设备利用了“回流”特征,该“回流”特征使用切段特征来表明该密封元件的位置处于了大致所需的位置。接着使用基于引导线的系统来更精确地定位该密封元件。在一个优选实施例中,该设备包括传送管,其为长型部件的形状并且具有从其远侧区域上一点延伸到其近侧区域上一点的内腔。该内腔在其近侧和远侧区域处连接到长型部件的近侧和远侧端口,从而形成从该内腔到长型部件外表面的流道。在这一实施例中,该长型部件还具有保持在长型部件内并处于其远侧端口的远侧处的可分离密封元件。为了实现密封穿刺孔或与身体内腔(诸如血管)连通的其它开口,该密封元件可以是可生物吸收的毡、水凝胶或其它适合的材料。近侧端口和远侧端口间隔开足够远,从而当远侧端口处于被穿刺血管的管腔中时,近端端口处于患者身体外部。
该设备还在长型部件的内腔中设有闭塞装置,其闭塞装置具有相对较大直径的远侧部分,该远侧部分连接到具有更窄直径的杆上。将长型部件中的远侧端口定位在该闭塞装置的大直径部分的近侧。在这一优选实施例中,闭塞装置的远侧部分和杆具有共同的中央内腔,并且闭塞装置的远侧部分外表面具有基本平行于闭塞装置轴线的凹槽。该设备还设有穿过闭塞装置远侧部分外表面上的凹槽的引导线和穿过闭塞装置中央内腔的系绳。该引导线在其远端具有特殊的构造并在其近侧区域设有指示装置。这些特征便于该设备能够将密封元件布置在基本精确的位置上。一旦到达这一位置,将该长型部件回撤一小段距离并将闭塞装置保持静止,以便从长型部件中推出该密封元件。
穿过闭塞装置中央内腔的系绳以任何适当的方式系到或连接到该密封元件上,例如将系绳的远侧区域通过缠绕、环结和/或打结成围绕该密封元件或连接到该密封元件上。
使用中,本发明的设备可用于闭合例如已经执行了导管插入术后的股动脉上的穿刺伤口。典型的,将本发明的设备插穿过导管鞘,该导管鞘设有适于接合该设备的法兰或其它装置,以防止其进一步向远侧移动,这优选用于导管插入操作。当如此使用时,该设备穿过导管鞘直到闭塞装置远端处的密封元件和长型部件内的远侧端口位于股动脉的内腔中。当导管鞘上的接合装置阻止该设备进一步向远侧移动时,则用户将知道此时已经出现这一情形,。当这一情形出现时,血液将从近侧端口涌出来,因为当该远侧端口抵达血管(诸如股动脉)的内腔时,血液将从血管中穿过远侧端口流入并穿过长型部件的内腔从近侧端口流出。
接着,将该设备和该导管鞘一起回撤一小段距离,使得该远侧端口不再位于股动脉的内腔中,并且血流基本上被患者的组织和密封元件阻断而不能抵达远侧端口。
流出近侧端口的血液一旦停止或大量地减少,则用户将知道此时密封元件接近了所需位置。在这一点上,密封元件大约位于所需的位置上。接着回撤该设备直到连在传送管近侧部分上的盘接触到连于引导线近侧部分的盘,此时密封元件处于最终布置位置上。
连于引导线上的盘和连于传送管上的盘间隔开一小段距离,并允许比别的可能方式更精确地定位该密封元件。然而,值得注意的是,优选是使用这些盘,但是也可使用其它结构来实现同样的目的。
接着将引导线回撤到闭塞装置凹槽内的引导线管中,而将设备的其余部分保持在位。这时,该密封元件位于所需的位置上并可通过将长型部件回撤一小段距离来布置该密封元件,同时将该闭塞装置保持在位,如上所述。在进行布置之后,该闭塞装置的远端将基本位于该长型部件的远端处。引导线的远端将处于在引导线管和长型部件的内腔中,接着将闭塞装置和引导线作为一体从患者中回撤。系绳将保持与密封元件的连接,并用于如果要将密封元件从通向血管穿刺孔的组织通道中移走时拉回该密封元件。
如果将本发明的设备通过导管鞘进行传送,优选地提供一连接设备,使得当长型部件的远侧端口位于血管内腔内时,该导管鞘和该设备将形成彼此连接。如果此项工作完成,则作为一体的设备和导管鞘的回撤将是很容易的,这将使得该远侧端口维持在导管鞘的远端的远侧位置处。
在优选的实施例中,密封元件由可膨胀的材料制造,该材料诸如是由成束的聚乙醇酸(PGA)制成的毡,该材料由于其毡结构而进行膨胀以确保穿刺伤口的有效闭合。可替代的,该密封元件可由水凝胶制成,诸如羟丙基纤维素(HPC)多微孔水凝胶。该密封件还可涂覆有或以其它设有促进凝结的止血材料。
上面描述已经关注于密封股动脉上的穿刺伤口,但是应当理解的是本发明的设备可用于定位其它血管的内腔并用于密封它们中的穿刺伤口。为了理解,我们开始本发明更详细地描述。
附图说明
图1是本发明设备的示意图。
图2是图1所示设备沿A-A线的截面图。
图3示出了远端插入到血管内腔中的本发明的设备。
图4显示了此时基本上已经从血管内腔中回撤的本发明的设备。
图5显示了此时密封件已经正确定位的本发明的设备。
图6显示了在已经将密封件推入到组织通道中后的本发明的设备。
图7示出了图1中所示设备的系绳。
图8示出了其近端更多细节的本发明的设备。
图9示出了该设备的近端的其它细节。
图10示出了该设备把手中的开槽。
图11示出了本发明设备的分解透视图。
图12A和12B示出了图11中所示设备的多个部分,示出了其近端的其它细节。
图12C示出了精确定位特征的进一步细节。
图12D示出了图12A中所示设备沿D-D线的截面图。
本发明的详细说明
图1示意性地示出了本发明设备的许多特征部件。该设备10包括具有远侧端口12和近侧端口13的传送管11。闭塞装置14容纳在传送管11内并包括杆20和直径增大的远侧部分21。该设备10还具有引导线15,该引导线15具有横向延伸的远侧部分16。该设备还具有密封元件17,其优选由毡、水凝胶或其它适用于密封穿刺孔或与人体内腔(诸如血管)连通的其它开口的材料制成。
图2是图1所示设备沿A-A线的横截面图。如从图2中所见,该闭塞装置14的远侧部分21具有凹槽18,该凹槽18用作供该引导线15穿过的通道。另外,该闭塞装置14具有从其远端延伸到其近端的内腔19(未在图1中显示),该内腔用作供系绳(未显示)穿过的通道。
图3示出了该设备10将其远侧部分插入到血管23的内腔22中。如所见,该设备延伸穿过通道24,该通道24延伸穿过从患者皮肤25到血管壁中的穿刺孔26之间的组织。当如此定位后,该设备的回流特征部包括传送管11的远侧端口12、传送管11的内腔27和传送管11的近侧端口13,该回流特征部用于指示用户该传送管11的远侧部分定位在了血管内腔内,因为可以看见血液从近侧端口13流出。
图4示出了该设备10在其远侧部分(包括远侧端口12)已经从血管23的内腔22的内部回撤之后的状态。当该设备处于图4中所示的位置时,患者的组织和密封材料17已经大幅度缩小了,或者防止了血流到达该远侧端口12和近侧端口13。因此,用户将根据从端口13流出的血液明显减少而知道该密封材料17位于用来进行布置的大致合适位置。然而,在布置该密封材料17之前,优选地采取附加的定位步骤。
参考图4,可以看出,引导线的横向延伸的远侧部分16在该设备10回撤阶段并不与血管壁接触。
接着参考图5,可以看出,引导线的远侧部分16已经与接触血管壁23形成接触,另外,由于该壁施加给该远侧部分16的压力,已经将引导线的远侧部分16改变外形。因为存在阻止引导线15进一步向近侧移动的阻力,用户可感觉到该引导线的远侧部分与血管壁之间的这种接触。这种接触还可通过利用合适的措施(诸如利用荧光透视法)观测引导线远侧部分16的变形来确定。这一情形的发生可用来为密封元件17的布置而实现该设备的最终定位,如下面更充分的描述。
如图6中所示,通过向近侧回撤传送管11而同时保持闭塞装置14不动,从而来布置该密封材料17。这使得密封材料17被推出管11并位于血管通道24中靠近穿刺孔26的所需位置上。还向近侧回撤该引导线15,使得其远侧部分16穿过凹槽18并驻留在传送管11的内腔27中,或优选地,驻留在延伸穿过内腔27长度的引导线管34中(见图8)。优选地,该管11的远端将与闭塞装置14的增大部分21的远侧齐平。然后,通过将整个设备10从通道24中回撤,可将其从患者体内中取出。优选地,提供了延伸穿过该闭塞装置14的中央内腔19的系绳(未显示),并将其系在或以适当的其它方式连接到该密封元件17上。该系绳用于在存在任何需要将密封元件17从患者体内回撤的情况下,给用户至少一种控制密封元件17的措施。这可简单地通过向近侧拉动该系绳直到取出该密封元件17来实现。
图7中显示了将系绳28的远侧部分环绕在该密封元件17上时它们之间的关系,该图还显示了该闭塞装置14的远侧部分21和杆20具有贯穿其中延伸的中央内腔19。如上文所提到的,通过系结、环结或任何其它合适手段可将系绳28固定在密封元件17上。图7中所示的代表例子是用于说明性目的。
现在参考图8,关于其近侧结构更加详细地阐述了本发明的该设备。图8显示了具有远侧端口12和近侧端口13的传送管11,并且该传送管11在其内腔27内容纳有该闭塞装置的杆20和远侧部分21。该传送管11还具有引导线管34,其用作供引导线从该设备的近端穿过该闭塞装置的远侧部分21内的凹槽18的通道。还显示了密封元件17。
还显示了致动器31,该致动器31粘合至或以其它方式合适地连接至该传送管11。该致动器31具有凸起32,该凸起32具有与传送管11的近侧端口13对准的内腔33。该凸起32可用来向近侧和远侧移动该传送管11。在使用时,向近侧移动该致动器31而同时保持闭塞装置14不动,使得一旦传送管已经被正确定位,则该密封元件17就从传送管11中离开。帽35具有孔,闭塞装置14的杆20可穿过该孔进行滑动。围绕杆20提供一定长度的颈缩管51,以便提供一种可滑动的密封。帽35还具有用于引导线管34的孔,但是引导线管34粘合至或以其它方式合适地连接至帽35,使得致动器31的移动将引起传送管11和引导线管34作为一体进行移动。在传送管11的近端附近提供粘合材料52,以维持相对位置并相对于传送管11密封该颈缩管51和引导线管34。
该致动器31还具有凹部36,其优选为环形构造。该凹部36终止于底部37,如正对其它附图更详细解释的那样,该底部37用作弹簧座。
图9除示出了图8中所示元件之外,还进一步示出了该设备的近侧区域,并显示了凹部36中的按钮38,其中,弹簧38向近侧方向上偏压按钮36。按钮38的近端设有管39,引导线管34可穿过该管39进行滑动。还示出了手柄40,其围绕致动器31和按钮38。该手柄40设有L形开槽41,这在图10中有更完整地阐述,凸起32能够在该开槽41内移动。该L形开槽在图9中部分地显示为元件41。引导线管34的固定到致动器31的近侧部分具有致动器盘42。引导线盘43接近该致动器盘42,该引导线盘43连接至该引导线15。致动器盘42和引导线盘43被弹簧45隔开。
图10中更详细地显示了手柄40中的L形开槽41。从该图中可以看出,凸起32既可在该开槽的短腿内横向于该设备的纵向轴线移动,又可在该开槽的长腿内沿轴向方向移动。
图11是本发明设备一个实施例的分解透视图。如在此所示出的,可以看出,手柄40包括上半部分46和下半部分47。手柄的上半部分46含有L形开槽41。还显示了具有凸起32和按钮38的致动器31,并且凸起32容纳并保持在L形开槽41中。带有远侧端口12的传送管11与引导线44的远侧部分一起构成了该设备的远侧部分。传送管11具有衬套48,当手柄的上和下半部分46和47结合在一起时,该衬套48延伸进入手柄40的远侧凹部49内。致动器盘42连接到引导线管34上并靠近其近端,而引导线盘43在接近致动器盘的位置处连接至该引导线。
转到图12A-D,显示了关于致动器31和致动器盘42及引导线盘43的其它细节。在图12A-B中,显示了致动器31,其具有定位在远侧部分的凸起32和定位在其近端处的按钮38。该致动器31包括两部分,近侧部分31a和远侧部分31b(见图12B)。致动器的近侧部分31a形成限制按钮38向近侧移动的内部台肩31c。弹簧44(图12B)向近侧方向上偏压该按钮。该引导线管34从致动器31向近侧延伸,引导线15位于引导线管34的内腔内部。致动器盘42连接至该引导线管34的近端,并且该引导线盘43在接近致动器盘42的位置处连接至引导线14。
参考图12C,将盘簧45设在致动器盘42和引导线盘43之间。盘簧45提供的力趋向于将两个盘42、43分开,即盘簧45相对于彼此向远侧偏压致动器盘42并向近侧偏压引导线盘43。
图12D提供了关于该设备的近侧部分的其它细节。如图所示,按钮38具有内腔53,用于注入上文关于图9所述的粘合材料52。闭塞装置的杆20连接到按钮38,管39也连接至该按钮38,引导线管34和引导线15能够穿过管39进行滑动。也显示了致动器31a的近侧部分,并在上文进行了充分的描述。
现在将描述涉及致动器盘42和引导线盘43操作的其它细节。致动器盘42和引导线盘43用于提供密封元件17在患者组织中所形成的通道24内的最终、精确定位。如前面所述,引导线盘43连接至引导线的14的近侧部分,而致动器盘42连接到引导线管34,该引导线管34依次又连接到致动器31。两个盘42、43被隔开一小段距离1,如图12C中所示。如上面所述,当设备10从血管内腔中回撤时,例如如图5中所示,在设备10的远端退出血管的撤退期间,引导线的远侧部分16接合该血管壁23。此时,该回流特征部将处于没有发生大量回流的状态,这表明该设备靠近了要布置密封元件17的位置。该设备的继续回撤将使得引导线15保持相对静止,这是因为引导线的远侧部分16与该血管壁相接合。同时,致动器31、致动器盘43和设备10的其余部分将继续向近侧移动。当致动器盘43接合引导线盘42时,即,当该设备已经从引导线远侧部分16接合血管壁的位置回撤一附加距离1时,则表明到达了最终的布置位置。在这一位置处,布置该密封元件17。
如上所述,通过使得传送管11相对于闭塞装置14向近侧移动,从而实现了密封元件的布置。这通过在L形开槽41中沿轴向滑动该凸起32来实现。因为该凸起32结合致动器31,因此该轴向移动使得致动器31和传送管11向近侧前进。同时,闭塞装置14保持就位,由此而在所选的位置上布置该密封元件17。当按钮38的近端接合手柄40的内部表面时,致动器31能够克服按钮弹簧44的弹力而在手柄40内向近侧移动。这样,连接至致动器31的传送管11能够相对于致动器14沿轴向移动。
虽然本发明易于进行各种修改及替代的形式,其特定的例子已经在附图中显示并在此详细地进行了描述。然而,应该理解的是本发明并不限于所公开的特定形式或方法,相反,本发明覆盖所有落在所附权利要求的精神和范围内的修改、等同物及替代物。

Claims (21)

1、一种用于密封身体内腔的壁中的穿刺孔的设备,包括
长型部件,该长型部件具有在其内的内腔和位于其远侧区域的远侧端口以及位于其近侧区域的近侧端口,每个所述端口与所述长型部件内的所述内腔相连通,
容纳在所述长型部件内的闭塞装置,所述闭塞装置的远侧部分具有相对大的外部尺寸,该远侧部分连接至杆,该杆从该远侧部分向近侧延伸,
所述闭塞装置具有从所述闭塞装置的远端向近侧贯穿所述杆而延伸的中央内腔,
位于该闭塞装置的远侧部分的外表面中的凹槽,和
引导线,其延伸穿过所述长型部件内的所述内腔并穿过所述凹槽,所示引导线的远侧区域能够阻挡向近侧的移动,但具有足够的柔性以通过所述凹槽向近侧回撤。
2、如权利要求1所述的设备,其在长型部件的远侧区域中设有密封元件,该密封元件位于该闭塞装置的远端的远侧。
3、如权利要求2所述的设备,还包括延伸穿过所述长型部件内的所述内腔的引导线管,其中,所述引导线保持在所述引导线管中。
4、如权利要求3所述的设备,还包括定位装置,用于将所述密封元件定位在靠近身体内腔的壁中的穿刺孔的位置。
5、如权利要求4所述的设备,其中,所述定位装置包括连接至所述引导线管的第一部件和连接至所述引导线的第二部件,所述第一和第二部件具有用于定位所述密封元件的空间关系。
6、如权利要求2所述的设备,还包括延伸穿过所述闭塞装置的中央内腔并连接至所述密封元件的系绳。
7、如权利要求1所述的设备,还包括连接至所述长型部件的致动器,所述致动器适于方便所述长型部件相对于所述闭塞装置的移动。
8、一种用于充分密封身体内腔中的开口的方法,包括:
将一闭合设备的至少远端通过一组织通道插入到所述身体内腔内,
确认该闭合设备的至少该远端处于所述身体内腔中,
从所述身体内腔中回撤该闭合设备的远端,使得该设备仍然保留在该组织通道中,并且
从所述闭合设备布置密封元件。
9、如权利要求8所述的方法,其中,所述确认步骤包括观察穿过所述闭合设备中所含内腔的血流。
10、如权利要求9所述的方法,其中,将位于该闭合设备的远端附近的远侧端口从所述身体内腔中回撤后,所述血流基本上被阻止。
11、如权利要求8所述的方法,进一步包括:
将所述闭合设备的所述远端定位在该组织通道内的位置,所述位置至少部分地是通过这样来确定的,即,穿过所述闭合设备延伸的一部分引导线接合至所述身体内腔的一部分。
12、如权利要求11所述的方法,其中,所述定位步骤包括:
将该引导线的远端部分与所述身体内腔的壁相接合,并且
该引导线的该远端部分与该身体内腔的该壁接合后,将该闭合设备回撤一预定距离。
13、如权利要求12所述的方法,进一步包括:
通过观察第一部件和第二部件来确认将所述闭合设备回撤了所述预定距离,其中,所述第一部件连接至所述闭合设备上的引导线管,所述第二部件连接至引导线。
14、如权利要求8所述的方法,其中,所述布置步骤包括:向远侧移动所述闭合设备的长型部件,而所述设备的闭塞装置保持在适当位置,由此从所述闭合设备的远端释放所述密封元件。
15、一种用于密封身体内腔的壁中的穿刺孔的设备,包括:
长型部件,其具有远侧端口,近侧端口,和连接所述远侧端口和近侧端口的通道,
延伸穿过至少一部分所述长型部件的闭塞装置,所述闭塞装置具有远侧部分,当所述长型部件向近侧回撤时,所述远侧部分适于选择性地防止一密封元件在近侧方向上移动,以及
延伸穿过所述长型部件的引导线,所述引导线在远侧区域具有横向布置的部分。
16、如权利要求15所述的设备,其中,所述密封部件位于该闭塞装置的远侧部分的远侧。
17、如权利要求15所述的设备,进一步包括延伸穿过所述长型部件内的内腔的引导线管,其中,所述引导线保持在所述引导线管中。
18、如权利要求17所述的设备,进一步包括定位装置,用于将所述密封元件定位在靠近身体内腔的壁中的穿刺孔的位置。
19、如权利要求18所述的设备,其中,所述定位装置包括连接至所述引导线管的第一部件和连接至所述引导线的第二部件,所述第一和第二盘具有用于定位所述密封元件的空间关系。
20、如权利要求15所述的设备,进一步包括从闭塞装置的远端延伸的中央内腔、和延伸穿过所述闭塞装置的中央内腔并连接至所述密封元件的系绳。
21、如权利要求15所述的设备,进一步包括连接至所述长型部件的致动器,所述致动器适于方便所述长型部件相对于所述闭塞装置的移动。
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EP1750590A1 (en) 2007-02-14
US20080065151A1 (en) 2008-03-13
CA2566631A1 (en) 2005-12-01
CN100508898C (zh) 2009-07-08
MXPA06013350A (es) 2008-03-11
CN101664324A (zh) 2010-03-10
JP2008500141A (ja) 2008-01-10
AU2005244989A1 (en) 2005-12-01
CN101664324B (zh) 2013-05-29
ATE539684T1 (de) 2012-01-15
US7361183B2 (en) 2008-04-22
AU2005244989B2 (en) 2010-09-16
US8579934B2 (en) 2013-11-12

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