CN103379937A - 包括可缩回的针的医疗部件***设备 - Google Patents

包括可缩回的针的医疗部件***设备 Download PDF

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CN103379937A
CN103379937A CN2012800088666A CN201280008866A CN103379937A CN 103379937 A CN103379937 A CN 103379937A CN 2012800088666 A CN2012800088666 A CN 2012800088666A CN 201280008866 A CN201280008866 A CN 201280008866A CN 103379937 A CN103379937 A CN 103379937A
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pin
armarium
distal end
interventional instrument
dilator
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CN103379937B (zh
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J·W·霍尔
R·C·帕特森
C·法恩沃斯
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CR Bard Inc
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    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/065—Guide needles
    • A61M2025/0656—Guide needles having a tip larger than the rest of the body
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0687—Guide tubes having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

本发明公开了用于辅助医疗设备在患者身体中的放置的***设备。例如，***设备可以被用来辅助导引器的放置，所述导引器为导管***身体中提供管道。在一个实施方案中，***设备包括针和针缩回组件，所述针可移除地设置在由医疗设备限定的内膛中。针缩回组件可以将所述针定位在第一位置、第二位置以及第三位置中的任一个上，在所述第一位置，所述针的远侧末端被设置为在所述医疗设备的远侧端远侧一预先确定的距离，在所述第二位置，所述针远侧末端被设置为是在远侧的但邻近所述医疗设备的所述远侧端，在所述第三位置，所述针远侧末端在所述医疗设备内膛中被缩回。

Description

包括可缩回的针的医疗部件***设备
相关申请的交叉引用：本申请要求2011年2月25日递交的、题为“包括可缩回的针的导引器组件（Introducer Assembly Including a Retractable Needle）”的美国临时专利申请No.61/446,817的权益，该美国临时专利申请通过引用被整体并入本文。
发明内容
简要概述，本发明的实施方案涉及用于辅助医疗设备在患者身体中的放置的***设备。例如，***设备可以被用来辅助导引器的放置，所述导引器提供到身体中的管道（conduit）来使得导管的***得以进行。
在一个实施方案中，***设备包括针和针缩回组件，所述针可移除地设置在由医疗设备限定的内膛（bore）中。针缩回组件能够将所述针定位在第一位置、第二位置以及第三位置中的任一个上，在所述第一位置，所述针的远侧末端被设置为在所述医疗设备的远侧端远侧一预先确定的距离，在所述第二位置，所述针远侧末端被设置为是在远侧的但邻近所述医疗设备的所述远侧端，在所述第三位置，所述针远侧末端在所述医疗设备内膛中被缩回。
如所述的，在一个实施方案中，医疗设备为导引器组件，所述导引器组件包括同轴地设置在护套中的扩张器，其中所述针设置在由扩张器限定的内膛中。针缩回组件可以包括壳体，所述壳体可移除地附接到扩张器的近侧端。针的套接件（hub）可以可滑动地设置在所述壳体中，使得所述针在上面所描述的三个针位置中的任两者之间的手动移动得以进行。如将可见的，三个针位置中的每个便利医疗设备到患者体内的方便***而使对患者的创伤最小。
本发明实施方案的这些和其他特征将从下面的说明和所附的权利要求书中变得更加完整清晰，或者可以通过对由下文所阐明的本发明实施方案的实践来获悉。
附图说明
将通过参考本发明的具体的实施方案提供对本发明的更加具体的描述，所述的具体实施方案在所附的附图中被图示说明。可以理解，这些附图仅描绘本发明的典型实施方案，因而不能被认为是对本发明范围的限制。将通过使用说明书附图来以附加的特征和细节对本发明的示例性实施方案进行描述和解释，其中：
图1A-图1C是根据一个实施方案的***设备的各种视图；
图2A和图2B是图1A-图1C的***设备的部分剖视图；
图3A-图3C以各种配置示出图1A-图1C的***设备；
图4A-图4E示出根据一个实施方案的使用***设备将导引器***患者体内的各步骤；
图5A和图5B示出根据一个实施方案的***设备；
图6是根据一个实施方案的***设备的顶视图；
图7A-图7C示出根据一个实施方案的图1A-图1C的***设备的针的***的细节；
图8示出根据一个实施方案的***设备的壳体；以及
图9A-图9C示出根据一个可能的实施方案的***设备的远侧部分。
具体实施方式
现在将参考附图，其中相似的结构将被提供以相似的参考编号。可以理解，附图为本发明的示例性实施方案的图解的和示意的表征，并且所述附图为非限制性的，也无须按比例绘制。
为清楚起见，将理解到的是，词语“近侧的（proximal）”是指相对地更靠近使用本文将描述的所述设备的临床医生的方向，而词语“远侧的（distal）”是指相对地更远离临床医生的方向。例如，被放置在患者体内的导管的端被认为是所述导管的远侧端，而所述导管仍保留在体外的端为所述导管的近侧端。另外，如本文（包括权利要求书）所使用的词语“包括（including）”、“具有（has）”以及“具有（having）”，应当具有同词语“包括（comprising）”相同的意思。
本发明的实施方案总地涉及用于辅助医疗设备在患者身体中的放置的***设备。例如，***设备可以被用来辅助导引器的放置，该导引器提供到患者身体中的管道，以使得导管通过该导引器的***得以进行。在另一实施例中，***设备可以用来将导管直接放置到患者的身体中而不使用导引器。还可以利用本文描述的***设备放置其他医疗设备。在一个实施方案中，***设备包括针，在使用该设备期间所述针可定位在三个或更多个位置中的一个上，从而方便医疗设备***身体。
首先参照图1A-图1C，图1A-图1C根据一个实施方案示出关于***设备（一般地以10标示）的各种细节。如所示的，设备10与导引器12初始地配接，导引器12又包括导引器套接件14和从套接件向远端延伸的护套本体（“护套”）16。导引器套接件14限定握持部来在使用期间用于操纵导引器12。导引器12的导引器套接件14和护套16一起限定纵向内膛。尽管在此处被配置为是可***的，然而在其他实施方案中导引器无需是可***的。
扩张器20同轴地设置在导引器12的内膛中。如所示的，扩张器20包括套接件22和从该套接件向远侧延伸的本体24。扩张器套接件22和本体24一起限定通过其中的内膛，用于通过可选的导丝。扩张器套接件22限定基底部分22A和帽部分22B。如图1A-图1C中所示的，帽部分22B被配置来螺纹接合导引器12的套接件14，从而可释放地配接导引器和扩张器20。在这一配接的配置中，可见的是，扩张器本体24的锥形远侧部分26延伸超过导引器护套16的远侧端。
图1A-图1C进一步示出这样的空心针30，该空心针30同轴地设置在扩张器20的内膛中，以致其尖锐的远侧末端30B初始地向远侧延伸通过扩张器20的锥形部分26。针30的近侧端30A连接到针套接件32（图2A、图2B）。如将被描述的，针套接件32与针缩回组件40协作来相对于导引器组件轴向地选择性移动针30。例如，闪现孔（flash hole）34可以被包括在针30靠近其远侧末端30B的壁中，从而帮助检测血液的存在并且确定针远侧末端在静脉中的定位。在其他实施方案中，闪现孔或用于确定针中存在血液的其他适合的部件可以被安置在设备上的其他位置。在一个实施方案中，例如，闪现窗（flashwindow）可以被提供在扩张器套接件基底22A中或者靠近扩张器套接件基底22A。此外，尽管此处是空心的，然而在其他实施方案中，针可以为实心的。
针缩回组件40与***设备10一起被包括并且包括与扩张器套接件22的基底部分22A螺纹接合的壳体42。壳体42限定腔，针30的套接件32被可滑动地设置在该腔中。如所示的，针30从针套接件32向远侧延伸通过由扩张器20的套接件22和本体24限定的内膛，来延伸超过扩张器的锥形远侧部分26。
针套接件32的两个握持部44经由限定在壳体42中的纵向延伸槽46在针缩回组件42外部延伸。由此，针套接件32在壳体42内朝向其近侧端的滑动运动引起针30的远侧末端30B的相应近侧移动。类似地，针套接件32在壳体42内朝向其远侧端的远侧移动引起针远侧末端30B的相应远侧移动。由此可见的是，握持部44提供选择性地移动针套接件32和针30的一种方式。然而，应当理解的是，其他结构或方法可以用来选择性地移动针，包括弹簧或其他偏置部件、自动致动器或者基于机器或电子的致动器等。此外，尽管出现在图示说明的实施方案中，然而理解的是，在其他实施方案中，没有壳体与针缩回组件一起被包括。
图2A和图2B描绘关于针套接件32和针缩回组件40的进一步细节。针套接件位置锁定构件与针套接件32一起被包括，此处被实施为从针套接件径向地延伸的两个相对的齿48。齿48被配置来在针套接件32在壳体内轴向地滑动时接合与壳体42一起被包括的凹口50，由此将针套接件锁定在针缩回组件壳体40内的预先确定的位置。具体地，近侧凹口50A和远侧凹口50B被包括在壳体42中并且下面将被进一步描述。
如在图2B中最佳可见的，针套接件32进一步限定与空心针30共轴的管道52，从而能够使导丝（例如图3A中所示的导丝60）通过***设备10的壳体42、针套接件以及针，以致导丝延伸通过针的远侧末端30B。圆锥结构54被限定在管道52的近侧端处，以便于导丝60***针套接件32。在另一实施方案中，没有导丝与***设备一起被包括，并且没有导丝管道被提供。
根据本发明，***设备10的针30相对于导引器组件是轴向可移动的。如上面提到的，针缩回组件40包括这样的结构，用来使得针能够被选择性地移动，从而便利其中设置***设备10的医疗设备（在这种情况下，导引器组件（图1A-图1C））的方便***。注意的是，虽然此处示出导引器组件，然而在其他实施方案中，如下面进一步图示说明的，各种各样的医疗设备可以在本文描述的***设备的辅助下被***患者体内。
具体地，图3A示出相对于扩张器组件的护套12和扩张器20的针30的第一位置，其中针的远侧末端30B向远侧延伸超过扩张器本体24的远侧端一预先确定的距离。如在图2A和图2B中可见的，针远侧末端30B的这一延伸对应于针套接件32邻近针缩回组件40的壳体42的远侧端的位置。针30的远侧末端32B的这一位置在本文中也被称为位置1。在位置1，针30被定位来获得对患者身体的内部部分（例如，静脉或其他血管）的进入。导丝60也被示出为可滑动地设置在针缩回组件40和导引器组件中，并且延伸通过针缩回组件40和导引器组件，从而从针远侧末端32B向远侧延伸。
注意的是，在其他实施方案中，针远侧末端延伸通过扩张器远侧端的特定距离可以根据各种因素而变化，包括针长度、针套接件在针缩回组件壳体中行进的距离、医疗设备的长度等。
图3B示出相对于导引器组件的护套12和扩张器20的针30的第二位置，其中针的远侧末端30B向远侧延伸超过扩张器本体24的远侧端一相对短的距离，从而邻近扩张器本体24的锥形远侧部分26的远侧端。当针套接件32通过针套接件握持部44上的使用者的力而从图3A中所示的位置被手动滑动到图3B中所示的位置时，达到针远侧末端30B的该位置，在该位置，针套接件被定位在沿针缩回组件壳体42的长度的约中间部分。在该位置，针套接件32的齿48以摩擦方式接合凹口50B，由此将针套接件锁定在恰当位置，直到握持部44上的充分的使用者的力将它移离其位置。
图3B中的针30的远侧末端32B的位置在本文中也被称为位置2。如将可见的，在位置2，针30的远侧末端30B被定位来辅助扩张器本体24的锥形远侧部分26获得对患者的血管或其他内部身体部分的进入。
图3C示出相对于导引器组件的护套12和扩张器20的针30的第三位置，其中针的远侧末端30B在扩张器本体24的内膛中被缩回，从而免于与扩张器本体和导引器12的本体16接触。当针套接件32通过针套接件握持部44上的使用者的力而从图3B中所示的基本上中线位置被手动滑动到图3C中所示的位置时，达到针远侧末端30B的该位置，在该位置，针套接件被定位为邻近针缩回组件壳体42的近侧端附近。在该位置，针套接件32的齿48以摩擦方式接合近侧凹口50A，由此将针套接件锁定在恰当位置，直到握持部44上的充分的使用者的力将它移离其位置。
图3C中的针30的远侧末端32B的位置在本文中也被称为位置3。如将可见的，在位置3，针30的远侧末端30B被缩回并且被设置为邻近扩张器本体24的锥形远侧部分26，从而使得在推进到患者血管中的过程中导引器组件的远侧部分能够弯折。此外，在针远侧末端30B安全地设置在扩张器本体24中的情况下，位置3防止在扩张器20和导引器12被推进到血管中时针30对血管造成损害的风险。进一步注意的是，尽管在本文中描述为针相对于固定的导引器/扩张器的移动，然而在其他实施方案中，导引器和/或扩张器可以相对于固定的针移动，从而达到上面所描述的三个位置。
除了上面描述的齿和凹口锁定布置之外，理解的是，用于相对于针缩回组件的壳体锁定针套接件位置的其他构件可以如本领域中的技术人员所理解的那样来使用。此外，关于***设备的可能的数目和针远侧末端位置可以不同于本文所描述的内容。此外，被配置来***身体的***设备和医疗设备的尺寸、形状以及配置可以不同于本文所示出和描述的内容。
图4A-图4E根据一个实施方案描绘关于使用***设备10辅助导引器组件***患者血管的各种细节。注意的是，要被放置的医疗设备和该设备要被放置的患者身体内的期望位置可以不同于本文描述的内容。在图4A中，***设备10如上面说明的那样已经被先前地附接到导引器组件并且在针30处于位置1（图3A）的情况下，针的远侧末端30B***患者的皮肤62并***期望的皮下血管64的内腔。在一个实施方案中，限定在针30中的闪现孔34（图1A）可以辅助观看血液从针往上返回，从而确定血管64中的恰当针放置。一旦血管64已经被进入，导丝60可以被使用者手动地推进通过针缩回组件的壳体42和针30，从而延伸进入血管内腔。
在图4B中，一旦导丝已经被***血管64，则针30被缩回到位置2（图3），以致针远侧末端30B邻近扩张器本体24的锥形远侧部分26。如所示的，这可以导致针远侧末端从血管***部位缩回一短的距离，而导丝60保持在血管64中的恰当位置并且延伸通过血管***部位。
针30缩回到位置2使得其远侧末端30B能够辅助扩张器本体24的锥形远侧部分26通过血管***部位的进入并且循着先前放置的导丝60进入血管64。注意的是，在一个实施方案中，***设备或者医疗部件的针或另一适合部分可以被处理，从而是以超声方式可视的，以致本文描述的步骤中的一个或更多个可以在超声成像引导的辅助下执行。
图4D示出一旦针远侧末端30B和扩张器本体24的锥形远侧部分26被设置在血管64中，则针可以被缩回到位置3（图3C），其中针的远侧末端被设置在扩张器本体24的内膛中邻近扩张器远侧端一预先确定的距离。如已经描述的并且如其他针位置的情况，针缩回组件40将针套接件32可释放地锁定在适当位置上，从而在位置3，针远侧末端在扩张器内膛中可以保持为被屏蔽的。针30在位置3时，扩张器20和导引器12可以被进一步向远侧推进到血管64中直到被***血管中期望的程度。因为针30没有出现在它们的远侧部分，所以导引器12和扩张器20是顺从的，从而弯曲并且符合血管64的形状。
图4E示出一旦导引器12已经被***血管64一充分的距离，则包括针30和针缩回组件40的***设备10与扩张器20可以一起被移除，由此将它们从导引器分离并且使导引器设置在血管中。导管然后可以通过导引器12被***到血管64中。
如果期望的话，如在图4E中可见的，当***设备10和扩张器20被移除时，导丝60可以被保持在血管64中恰当的位置，来进一步辅助导管或其他适合设备通过导引器12的放置。进一步理解的是，在一个实施方案中，上面的方法可以在不使用导丝的情况下来执行。
理解的是，多种类型的导管（包括PICC、PIV、居中或中线、CVC以及其他导管配置）可以利用本发明的设备被放置。还考虑***设备的其他使用情况。这样的其他使用情况的非限制性实施例包括人工支架（stent graft）、进给设备等的放置。***设备适合于动脉或静脉血管进入，并且适合于在各种身体腔内或体内位置上使用。如所提到的，在本实施方案中，针30可定位在三个位置上；然而，还考虑其他可能的针位置配置。
图5A和图5B描绘根据另一实施方案的***设备，其中针缩回组件不包括壳体。相反的是，针套接件72包括向远侧延伸的握持部，该握持部被成形和安置来便利设备的单手操作，例如图5B中所示的针30的缩回。因此，考虑***设备的这些和其他变法方式。
图6示出根据一个实施方案的***设备110的细节，其中针缩回组件140包括壳体142，导丝60延伸通过壳体142的至少一部分。按钮释放件144被包括在壳体142上，用来可选择地使针30从其位置1缩回，此处图示说明的是缩回到另一位置，例如上面描述的位置2或位置3。在一个实施方案中，按钮释放件144可操作地耦合到弹簧149或设置在壳体142中的其他偏置部件，以导致针30的缩回。针缩回组件140的壳体142还包括握持部148，用来选择性地推进导丝60通过针30。尽管在图6中图示说明为延伸通过***设备的近侧端，然而在其他实施方案中导丝可以被完全包含在针缩回组件的壳体中。
图7A-图7C图示说明，在一个实施方案中，合乎期望的是，当将针从位置1（图3A）移动到位置2（图3B）时，将针30的斜面150从斜面向上（bevel-up）配置转动到斜面向下（bevel-down）配置。特别地，图7A示出在位置1时针30***血管64，其中针远侧末端30B的斜面150在向上位置，即针的成角度的切割表面面向皮肤62的表面。图7B示出当针30被缩回到位置2时，斜面150可以被转动到斜面向下配置。如上面结合图4B和图4C描述的，图7C示出在斜面向下配置时，针30然后可以被再***血管64。这在针***和推进期间合乎期望地帮助防止由针与血管后壁的意外接触造成的血管64刺穿（gouging）。此外，当针30在导丝60上被推进到血管64中时，斜面向下配置降低针远侧末端30B割断导丝的机会。
图8示出便于上面描述的针远侧末端30B的斜面150的转动的结构的一个实施例，其中针缩回组件的壳体242包括可滑动地设置在其中的针套接件232。针套接件232的握持部244延伸通过壳体242的壁，来使得针套接件沿壳体的长度的手动移位得以进行。针套接件232的内部部分可操作地连接到由壳体242的内壁限定的螺旋轨道250，这使得针套接件在壳体内向近侧移动时能够绕其滑动轴转动。如图7A-图7C中可见的，由于针30的近侧端稳固地固定到针套接件32，所以针套接件的转动合乎期望地导致针远侧末端斜面150的相应转动。除此之外，在***设备中还可以采用用于导致针末端斜面转动的其他结构。
图9A-图9C示出根据一个实施方案的***设备的远侧部分的细节，其中导丝60没有被设置在空心针30中，而是在扩张器20的内膛260中被设置在针的旁边。特别地，在图9A中，针30被示出为在位置1上延伸，其中导丝在扩张器内膛260中缩回。在图9B中，针被缩回到扩张器内膛260中，处于位置3。在图9C中，导丝60延伸通过扩张器内膛260的远侧端。图9A-图9C中所示的针和导丝配置对于以下实施方式来说是有用的，其中期望使用的导丝比其他情况下将装配在针中的导丝更大，或者在以下情形下是有用的，其中期望使用的是相对更小的针，从而减少患者不适和过量出血。
本发明的实施方案可以以其他具体的形式实施，而不偏离本发明的精神。所描述的实施方案应被认为是在各方面都仅是作为图示说明性的而非限制性的。因而，本发明实施方案的范围由所附的权利要求书而非前述说明书所示出。在权利要求书的含义和等同范围内的所有变化都应被包含在本发明的范围内。

Claims (25)

1.一种用于将医疗设备***患者身体的***设备，所述医疗设备限定内膛，所述***设备包括：
针，所述针可移除地设置在所述医疗设备的所述内膛中；以及
缩回组件，所述缩回组件能够产生所述针和所述医疗设备的相对位置，所述相对位置包括第一位置、第二位置以及第三位置，在所述第一位置，所述针的远侧末端被设置为在所述医疗设备的远侧端远侧一预先确定的距离，在所述第二位置，所述针远侧末端被设置为是在远侧的但邻近所述医疗设备的所述远侧端，在所述第三位置，所述针远侧末端在所述医疗设备内膛中被缩回。
2.如权利要求1中限定的***设备，其中所述医疗设备是导引器组件，所述导引器组件包括护套和同轴地设置在所述护套中的扩张器，所述针设置在由所述扩张器限定的内膛中。
3.如权利要求2中限定的***设备，其中所述扩张器包括锥形远侧部分，在所述第二位置所述针的所述远侧末端为所述锥形远侧部分提供过渡。
4.如权利要求2中限定的***设备，其中所述缩回组件包括壳体，针套接件被设置在所述壳体中，所述针套接件附接到所述针的近侧端。
5.如权利要求4中限定的***设备，其中所述导引器护套的套接件螺纹接合所述扩张器的套接件的远侧端，并且其中所述缩回组件壳体螺纹接合所述扩张器的所述套接件的近侧端，在完成将所述导引器护套放置在患者身体中之后，所述缩回组件和扩张器从所述导引器护套是可移除的，所述缩回组件的移除还导致所述针从所述导引器护套移除。
6.如权利要求5中限定的***设备，其中所述针套接件被可移动地设置在所述缩回组件的所述壳体中，来使所述针在所述第一、第二以及第三位置之间移动。
7.如权利要求6中限定的***设备，其中所述针套接件包括至少一个凸起构件，来接合所述缩回组件壳体的至少一个凹陷构件，从而可释放地锁定所述针套接件并且将所述针保持在所述第一、第二以及第三位置中的一个上。
8.如权利要求7中限定的***设备，其中当所述针位于所述第一位置时，所述针远侧末端的斜面在第一方向上定向，并且其中当所述针位于所述第二位置时，所述斜面在第二方向上定向。
9.如权利要求8中限定的***设备，其中在所述针从所述第一位置到所述第二位置的移动期间，所述针套接件轴向地转动，从而将所述针远侧末端的所述斜面从所述第一方向改变为所述第二方向，其中在所述针远侧末端接触血管的后壁时，所述斜面的所述第二方向减少血管损伤。
10.如权利要求1中限定的***设备，其中所述针是空心的，用于导丝通过所述针，所述导丝还通过所述针缩回组件壳体，在所述缩回组件和所述针从所述医疗设备被移除之后，所述导丝能够与所述医疗设备保持在一起。
11.如权利要求1中限定的***设备，其中所述针在所述第一位置用来获得对患者身体的内部部分的针进入，所述针在所述第二位置用来辅助所述医疗设备的第一远侧部分获得对所述内部部分的进入，并且所述针在所述第三位置用来使得所述医疗设备的第二远侧部分能够获得对所述内部部分的进入。
12.如权利要求1中限定的***设备，其中所述针的近侧端附接到针套接件，所述针套接件包括向远侧延伸的握持部，来使得所述***设备的单手抓握得以进行并且使得所述针在所述第一、第二以及第三位置之间的移动得以进行。
13.如权利要求1中限定的***设备，其中所述缩回组件包括：
壳体；
偏置部件，所述偏置部件设置在所述壳体内，所述偏置部件被配置来在所述第一、第二以及第三位置中的至少两个之间移动所述针；
导丝；以及
导丝握持部，所述导丝握持部从所述壳体延伸并且被配置来使得所述导丝的手动推进得以进行。
14.如权利要求1中限定的***设备，其中所述医疗设备为导管，并且其中当所述针位于所述第三位置时，在***患者期间使得所述导管的所述远侧部分是能够弯曲的。
15.一种用于将限定内膛的细长医疗设备***患者身体的方法，所述方法包括：
（a）提供***设备，所述***设备包括可移除地设置在所述医疗设备的所述内膛中的针，所述针被这样初始地定位在第一位置上，以致所述针的远侧末端被设置为在所述医疗设备的扩张远侧端远侧一预先确定的距离；
（b）在所述针位于所述第一位置时将所述针的至少所述远侧末端***身体；
（c）使所述针从所述第一位置缩回到第二位置，以致所述针远侧末端被设置为是在远侧的但邻近所述医疗设备的所述扩张远侧部分；以及
（d）在所述针位于所述第二位置的情况下，将所述针远侧末端和所述医疗设备的所述扩张远侧部分推进到身体中。
16.如权利要求15中限定的用于***的方法，还包括：
（e）再使所述针从所述第二位置缩回到第三位置，以致所述针远侧末端在所述医疗设备的所述内膛中被缩回；
（f）将所述医疗设备进一步推进到身体中来将所述医疗设备定位在身体中的期望位置；以及
（g）从所述医疗设备移除所述***设备。
17.如权利要求16中限定的用于***的方法，其中所述针可操作地附接到包括壳体的针缩回组件，所述壳体可移除地附接到所述医疗设备，并且其中移除所述***设备的步骤还包括：
从所述医疗设备分开所述壳体；以及
解除所述针和针缩回组件与所述医疗设备的接触。
18.如权利要求17中限定的用于***的方法，其中使所述针从所述第一位置缩回到所述第二位置的步骤还包括：将所述针远侧末端的斜面从第一定向转动到第二定向。
19.如权利要求18中限定的用于***的方法，其中所述医疗设备为导引器组件，所述导引器组件包括同轴地设置在护套中的扩张器，所述导引器被配置来***到患者的血管中，所述针同轴地设置在所述扩张器的所述内膛中，并且其中推进所述针远侧末端的步骤还包括将所述针远侧末端和所述扩张器的锥形远侧部分推进到所述血管中，并且其中推进所述医疗设备的步骤还包括将所述护套的远侧部分推进到所述血管中。
20.如权利要求15中限定的用于***的方法，其中所述医疗设备意图用于***血管，并且其中所述方法还包括在步骤（b）之后并且在步骤（c）之前，在通过所述针能够进入所述血管之后将导丝推进到所述血管中。
21.如权利要求20中限定的用于***的方法，其中所述导丝从所述医疗设备的所述内膛向远侧延伸但没有被设置在所述针的内腔中。
22.一种用于将导引器组件***患者的血管的***设备，所述导引器组件包括同轴地设置在护套中的扩张器，所述***设备包括：
针，所述针可移除地且同轴地设置在所述导引器的所述扩张器中，所述针包括针套接件；以及
针缩回组件，所述针缩回组件包括可移除地附接到所述导引器组件的壳体，所述针套接件可移动地设置在所述壳体中，来将所述针定位在第一位置、第二位置以及第三位置中的任一个上，在所述第一位置，所述针的远侧末端被设置为在所述扩张器的远侧端远侧一预先确定的距离，在所述第二位置，所述针远侧末端被设置为是在远侧的但邻近所述扩张器远侧端，在所述第三位置所述针远侧末端在所述扩张器中被缩回。
23.如权利要求22中限定的***设备，其中所述针在所述第一位置被用来获得对患者皮下血管的针进入，所述针在所述第二位置被用来辅助所述扩张器的所述远侧部分获得对所述内部部分的进入，所述针在所述第三位置被用来使得所述护套在所述血管中能够被推进。
24.如权利要求22中限定的***设备，其中所述针是空心的并且其中导丝延伸通过所述壳体和所述针，在所述第一位置，在所述针已经获得对所述血管的进入之后所述导丝被初始地推进到所述血管中。
25.如权利要求24中限定的***设备，其中所述针套接件包括至少一个握持部，所述至少一个握持部延伸通过限定在所述壳体中的纵向槽，所述握持部使得所述针套接件的手动滑动运动得以进行，并且其中所述针套接件在所述壳体中的第一、第二以及第三位置对应于所述针的所述第一、第二以及第三位置。
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