CN111801133A - 用于医疗装置插入系统的导丝推进和血液闪回系统 - Google Patents

用于医疗装置插入系统的导丝推进和血液闪回系统 Download PDF

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CN111801133A
CN111801133A CN201980016849.9A CN201980016849A CN111801133A CN 111801133 A CN111801133 A CN 111801133A CN 201980016849 A CN201980016849 A CN 201980016849A CN 111801133 A CN111801133 A CN 111801133A
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needle
guidewire
housing
catheter
insertion tool
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CN111801133B (zh
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H·N·德兰
D·B·布兰查德
J·R·斯塔斯
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Bard Access Systems 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
    • A61M25/0662—Guide tubes
    • 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
    • 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
    • A61M25/06—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
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • 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
    • A61M25/0693—Flashback chambers
    • 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
    • A61M25/09041—Mechanisms for insertion of 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human body

Abstract

本发明的实施方案涉及导丝推进和血液闪回系统。具体地，插入工具包括易碎导丝杆，其配置为如果导丝被卡住则破碎并且阻止导丝进一步移动。此特征可以防止导丝的远侧部分破碎，否则可能不期望地导致栓塞。插入工具可以进一步包括血液闪现指示器，该血液闪现指示器与针简化联接。插入工具可以进一步包括导丝推进组件，其配置为允许临床医生在远端附近握住插入工具并且使用一只手操作导丝推进，同时提供对插入工具的增强控制。插入工具可以进一步包括安全夹，该安全夹与导管衬套联接并且配置为当从装置拆卸导管时围绕针尖闭合。

Description

用于医疗装置插入系统的导丝推进和血液闪回系统
优先权
根据35U.S.C.§119(e)，本申请要求2018年3月7日提交并且标题为“GuidewireAdvancement And Blood Flashback Systems For A Medical Device InsertionSystem”的美国临时申请号62/639,790的优先权，其在此通过引用以其整体并入本申请。
发明内容
简而言之，本文公开的实施方案涉及导管插入工具及其方法。
本文公开了一种用于将医疗装置插入患者体内的插入工具，其在一些实施方案中包括壳体、针、推进组件和导丝推进组件。推进组件被配置为选择性地推进医疗装置，用于放置在患者体内。导丝推进组件被配置为在推进医疗装置之前选择性地推进导丝。导丝推进组件包括第一部分、第二部分和将第一部分与第二部分物理互连的易碎(frangible)部分。导丝被可操作地附接至第一部分或第二部分中的一个。易碎部分被配置为当在其上施加预定大小的力时破碎。
在一些实施方案中，在易碎部分破碎时，基本上阻止了导丝的近侧缩回。
在一些实施方案中，施加在易碎部分上的力是张力。
在一些实施方案中，力的预定大小小于使导丝破碎需要的力的第二预定大小。
在一些实施方案中，第一部分和第二部分通过易碎部分和铰接部分互连。
在一些实施方案中，当易碎部分破碎时，第一部分和第二部分围绕铰接部分相对于彼此枢转。第一部分和第二部分的枢转移动抑制了导丝的进一步移动。
在一些实施方案中，当预定大小的力被施加在第一部分和第二部分上时，第一部分和第二部分彼此分离，引起易碎部分破碎。
还公开了一种用于将医疗装置放置在患者的脉管系统内的插入工具，其在一些实施方案中包括壳体、指示器管和针。指示器管包括指示器管内腔。针包括针内腔和布置在针的侧壁中的孔。孔将针内腔与指示器管内腔流体连接。
在一些实施方案中，指示器管延伸通过壳体的半透明部分。
在一些实施方案中，半透明部分是用于将医疗装置推进入患者的脉管系统的翼部。
在一些实施方案中，指示器管沿着壳体的表面延伸。
在一些实施方案中，针包括通过针的侧壁的第二针孔，其与(第一)针孔相对布置。
在一些实施方案中，来自针的血流进入指示器管的内腔，并且沿着指示器管内腔以相反的方向流动远离针。
还公开了一种用于将导管放置在患者的脉管系统内的导管放置工具，其在一些实施方案中包括壳体、导管、针、针安全夹、导丝和导丝推进组件。壳体沿着纵向轴线延伸并且包括壳体的近端和远端。导管包括导管衬套(catheter hub)。针安全夹包括底板(baseplate)和一个或多个支撑臂(support arm)，该支撑臂配置为将针安全夹可释放地固定至导管衬套。导丝推进组件被联接至导丝。导丝推进组件被布置在壳体内。借助于靠近壳体的远端的开口，导丝推进组件的一部分是可进入的(accessible)。
在一些实施方案中，导丝推进组件包括导丝推进器和柔性轨道(track)。当在远侧方向上推进柔性轨道时，柔性轨道是通过壳体的开口可操作的，以在远侧方向上推进导丝。
在一些实施方案中，柔性轨道包括沿着纵向轴线延伸的狭缝，该狭缝配置为允许导丝、导管或针中的至少一个通过其穿过。
在一些实施方案中，当在远侧方向上推进导丝推进组件时，柔性轨道的远端行进通过基本上180°的弧。
在一些实施方案中，导丝推进组件与壳体的内部部分密封隔离。
在一些实施方案中，壳体包括壳体的半透明部分和内部部分，当针的远侧尖端进入患者的脉管系统时，该壳体的内部部分填充有血液。
在一些实施方案中，一个或多个支撑臂中的每个臂各自包括布置在其远端处的止动器(detent)。每个支撑臂的止动器被配置为接合导管衬套中的对应的缺口。
在一些实施方案中，针安全夹的底板包括配置为可滑动地接合针的孔。
还公开了一种放置医疗装置的方法，其在一些实施方案中包括在多个步骤中的第一步骤中提供插入工具。插入工具包括壳体、针、导丝、导丝推进组件、医疗装置和血液闪现(blood flash)指示器。壳体包括半透明部分和在壳体的上表面上的靠近壳体的远端的壳体开口。针从壳体的远端延伸并且包括从针的远端向近侧延伸的内腔。导丝推进组件被布置在壳体内，可操作地附接至导丝并且通过壳体开口可进入。血液闪现指示器与针内腔流体连接并且延伸通过壳体的半透明部分。除第一步骤之外，多个步骤包括使用一只手靠近插入工具的远端抓握插入工具；将针的远端推进入患者的脉管系统；允许血液通过针内腔向近侧流动至血液闪现指示器；通过壳体的半透明部分观察血液闪现指示器中血液的存在；通过如下在远侧方向上推进导丝：使用一只手的手指通过壳体开口进入导丝推进组件，并且在远侧方向上推进导丝推进组件；和沿着导丝推进医疗装置。
还公开了一种在放置导管后移除导管放置工具的方法，其在一些实施方案中包括在多个步骤中的第一步骤中提供医疗装置放置工具。医疗装置放置工具包括导管、针、针安全夹、导丝和导丝推进组件。导管包括导管衬套。针安全夹与针可滑动地接合并且被可释放地固定至导管衬套。导丝被配置为在第一预定大小的力下破碎。导丝推进组件包括易碎连接部分，其配置为在第二预定大小的力下破碎。除第一步骤之外，多个步骤包括使用导丝推进组件在近侧方向上缩回导丝；从导管向近侧缩回针，使得针安全夹滑动至针的远端；和当针安全夹到达针的远端时，使导管与针安全夹脱离。
在一些实施方案中，第一预定大小的力大于第二预定大小的力。
在一些实施方案中，针安全夹包括三个支撑臂，其配置为将针安全夹可释放地固定至导管衬套。三个支撑臂中的每个臂各自包括布置在支撑臂的远端处的止动器。止动器被配置为接合导管衬套中的对应的缺口。
在一些实施方案中，当导管衬套从针安全夹释放时，三个支撑臂围绕针尖闭合。
附图说明
将通过参考在附图中展示的本公开文本的特定实施方案呈现本公开文本的更具体的描述。应当明白，这些附图仅描绘了本发明的典型实施方案，并且因此不应当被视为限制本发明的范围。通过使用附图，将通过附加的特征和细节描述和解释本发明的示例性实施方案，在附图中：
图1A至1F是根据一个实施方案的导管插入工具的各种视图；
图2是图1A至1F的插入工具的分解视图；
图3A和3B示出了图1A至1F的插入工具的各种视图；
图4是根据一个实施方案的图1至1F的导丝推进组件和导管推进组件的俯视图；
图5是根据一个实施方案的图1A至1F的插入工具的导丝推进组件的透视图；
图6A至6B示出了图5的导丝推进组件的操作的细节；
图7是处于一种状态的图1A至1F的插入工具的透视图；
图8A至8C是根据一个实施方案的图1A至1F的导管插入装置的导丝杆(lever)的侧视图和特写视图；
图9A至9C是根据一个实施方案的图1A至1F的导管插入装置的导丝杆的侧视图和特写视图；
图10是根据一个实施方案的血液闪现指示器的透视图；
图11是根据一个实施方案的血液闪现指示器的透视图；
图12A至12B是包括图11的血液闪现指示器的导管推进组件的各种视图；
图12C是配备有图12A至12B的血液闪现指示器的导管插入装置的透视图；
图13是根据一个实施方案的配备有血液闪现指示器的导管插入装置的透视图；
图14A是根据一个实施方案的导管插入装置的透视图；
图14B是14A的导管插入装置的分解视图；
图14C至14F示出了图14A的导管插入装置的各种视图；
图15A至15E示出了用于图14A的导管插入装置的导丝推进组件的各种视图；
图16A至16B示出了图14A的导管插入装置的各种透视剖视图；
图17A至17F示出了根据一个实施方案的针安全夹的各种视图；和
图18A至18B示出了与图17A至17F的针安全夹接合的导管衬套的各种特写视图。
具体实施方式
现在将参考附图，其中相同的结构将具有相同的附图标记。应当理解，附图是本发明的示例性实施方案的图解和示意性表示，并且既不是限制性的也不一定按比例绘制。
为清楚起见，应当理解，词语“近侧”是指相对靠近使用本文描述的装置的临床医生的方向，而词语“远侧”是指相对远离临床医生的方向。例如，放置在患者体内的导管的一端被认为是导管的远端，而留在体外的导管端是导管的近端。此外，本文(包括权利要求书)中使用的词语“包括”、“带有”和“具有”应当与词语“包含”具有相同的含义。
简而言之，本文的实施方案总体上涉及一种用于将导管或其他管状医疗装置插入患者体内的插入工具。在一个实施方案中，插入工具将针插入、导丝推进和导管插入整合在单个装置中以提供简便的导管放置手术。
在一个实施方案中，插入工具包括壳体，导管的至少一部分最初被布置在该壳体中；空心针，其从壳体向远侧延伸，其中导管的至少一部分预先布置在针上；和导丝，其预先布置在针内。还包括推进组件，用于在准备导管的远侧推进中，选择性地向远侧推进导丝经过针的远端。在一个实施方案中，还包括导管推进组件，用于选择性地将导管推进入患者。每个推进组件可以包括使得临床医生能够选择性地推进期望的部件的滑动件(slide)或其他致动器(actuator)。这些组件协作以使得导管能够被适当地放置在患者的脉管系统或身体其他部分内。在另一个实施方案中，导管的任何部分最初均未被布置在插入工具壳体内部。
在一个实施方案中，导管推进组件还包括把手，其最初被可移除地附接至壳体内的导管的针衬套。临床医生对把手的远侧移动转而使导管从壳体向远侧移动。把手可以包括针安全部件，用于当从导管移除针并且将针的远侧尖端容纳入把手时隔离针的远侧尖端。另外，本文公开了各种导丝和导管推进组件。
在又一个实施方案中，与插入工具一起包括各种特征，该特征包括：在导管插入手术期间，在不移动临床医生的抓握插入工具的手的情况下，致动导丝和导管推进组件；基于先前对导丝或导管中的一个的推进，选择性地推进其中的另一个；和导丝钝化(blunting)特征。
在另一个实施方案中，导丝和导管推进组件各自包括用户接合部件，其被配置为使得用户可以在推进第一用户接合部件后开始推进第二用户部件，而基本上不重新放置用户进行推进使用的拇指或手指。
在又一个实施方案中，导管推进组件包括把手组件，其具有第一翼部(wing)和第二翼部。盖(cover)部分在第一翼部与第二翼部之间延伸，并且被定位使得导丝推进组件和导管推进组件的推进可以由临床医生的单个拇指或手指完成。
本文的实施方案进一步描述了插入工具的另外的方面，包括各种导丝推进组件和血液闪现指示器。
插入工具
图1A至2描绘了根据实施方案的插入工具10的各种细节。如图1A和2所示，插入工具10包括壳体12的顶部壳体部分12A和底部壳体部分12B，从壳体12延伸的导管42布置在针16上。还示出了可滑动地布置在狭槽1236(其限定在顶部壳体部分12A中)中的导丝推进组件20的指垫1218和导管推进组件40的把手组件1220的一部分。下面给出根据本实施方案的插入工具10及其各种细节的更多细节。本发明的插入工具的更多细节也可以见于2016年5月13日提交的U.S.2016/0256667，其在此通过引用以其整体并入。
图1A至1F示出了作为导丝推进组件20的一部分的指垫1218可以由临床医生的一个或多个手指沿着狭槽1236向远侧滑动，以便能够选择性地使导丝22(最初布置在针16的内腔中)经过针16的远端16B推进出。导丝22的近端被附接至顶部壳体部分12A的内部部分，使得指垫1218的单个单位的远侧滑动推进导致两个单位的远侧导丝推进。这通过在延伸入针16的内腔前使导丝22环化而完成，该环化来自导丝22在顶部壳体部分12A上的附接点并且通过在导丝杆24上包括的引导表面980(图6A和6B)。注意，在本实施方案中，导丝推进组件20的导丝杆24和指垫1218彼此一体形成，但是它们可以在其他实施方案中单独形成。还注意，导丝22可以被附接至插入工具10的其他外部或内部部分，包括底部壳体部分12B、针衬套1214等。
图1A至1F进一步示出了导管推进组件40(其用于将导管42从插入工具10的壳体12在远侧方向上选择性地推进出)包括把手组件1220，把手组件1220转而包括两个翼部1280等部件，当导管被推进时，临床医生的手指抓握两个翼部1280。如下文将进一步详细讨论的，翼部1280经由在顶部壳体部分12A与底部壳体部分12B之间限定的间隙1250向远侧推进。
顶部壳体部分12A和底部壳体部分12B经由顶部壳体部分的四个突片(tab)1230(图1D、2)与位于底部壳体部分上的四个对应的凹部1232的接合而配合在一起。当然，可以采用其他配合机构和方案将顶部壳体部分和底部壳体部分结合在一起。
图2中的插入工具10的分解视图示出了把手组件1220包括头部部分1222(翼部1280从其延伸)和尾部部分1224。头部部分1222和尾部部分1224均被可移除地附接至导管衬套46。插入工具10的布置在壳体12内的内部部件(其中的每个均被针16穿过)包括阀52、安全壳体54(滑架1008和针安全部件56被布置在其中)和安全壳体的帽58。还示出了与针安全部件56一起包括的O形环1002，以及针衬套1214，针衬套1214被固定至针16的近端并且被安装至壳体12以将针16固定在插入工具10内的适当位置。注意在图2中，在一个实施方案中，导丝推进组件20的指垫被布置在其中的狭槽1236包括相对宽的部分，以使得导丝杆24能够通过其被插入，以便将导丝推进组件联接至壳体12。
图3A和3B描绘了根据本实施方案的关于稳定结构70(其用于在针16从壳体12的出口处支撑和稳定针)的各种细节。如图所示，顶部壳体12A和底部壳体12B的近侧部分相互接合以提供用于针16的稳定结构70。底部壳体部分12B包括由狭槽1246分隔的两个在远侧布置的臂1248，当臂1248不受约束时，狭槽1246使得臂1248能够彼此分隔。顶部壳体部分12A限定远侧狭槽1240和在狭槽远侧的马蹄形特征1242。鉴于顶部壳体部分12A的向下弯曲(参见图1C)，狭槽1240使得底部壳体部分12B的臂1248向上突出通过狭槽，以包围和支撑针16，以便使针稳定。马蹄形特征1242围绕针16被布置在底部壳体臂1248的远端处，并且用作套环以使针稳定。
底部壳体部分12B的臂1248被配置为能够根据图3A和3B所示的x-y轴在x方向上来回移动，同时在y方向上保持基本上刚性。相反，包括狭槽1240和马蹄形特征1242的顶部壳体部分12A的远侧部分被配置为根据图3A和3B所示的x-y轴在y方向上挠曲，同时在x方向上保持基本上刚性。因此，当如图3A和3B所示重叠或相互接合时，当壳体12处于图3A、3B所示的构造时(即，在从壳体12移除导管42前)，稳定结构70的上述部件协作以支撑针16并且阻止其大幅移动。这转而帮助临床医生准确地穿刺皮肤并且进入患者的血管。应当明白，除本文明确描述的那些部件之外，稳定结构还可以包括用于稳定针的其他部件。
图4至7描绘了根据本实施方案的关于导管推进组件40和导丝推进组件20的各种细节。如所讨论的，导管推进组件40包括把手组件1220，把手组件1220转而包括头部部分1222(其具有对应的翼部1280)和尾部部分1224(其围绕导管衬套46和安全壳体54的一部分布置)。如将在下面进一步讨论的，把手组件1220用于向远侧推进导管42并且从插入工具10移除导管。
图4至7进一步示出了本实施方案的导丝推进组件20的指垫1218和导丝杆24。如图所示，导丝杆24从指垫1218向近侧延伸，并且在其近端包括先前讨论的用于引导导丝22环化的引导表面980。在导丝杆24的近端附近还包括致动块1258，用于实现导管推进。注意，致动块的具体尺寸、形状和其他构造可以与本文示出和描述的不同，同时保持期望的功能性。
弹簧臂1260从导丝杆24向下延伸，并且被配置为可滑动地保持在针衬套1214的两个导柱1264之间，如图6A和6B最佳所示。一旦导丝22已经从插入工具10完全向远侧延伸并且导管42推进一定的增量，弹簧臂1260被用于锁定导丝推进组件20的进一步移动。具体地，临床医生将指垫1218向远侧滑动引起导丝杆24也向远侧移动，这转而向远侧推进导丝22(其在内部环化，经过导丝杆24的引导表面980并且进入针内腔)通过针16的内腔并且经过针远端16B，如图7所见。
如图7所见，在指垫1218和导丝杆24完全向远侧推进时，弹簧臂1260的自由端被布置在袋(pocket)1266的正上方，该袋限定在针衬套1214的导柱1264之间，如图6B所见。由于在此阶段安全壳体54位于针衬套1214的近侧并且与其相邻(导管42以及附接的安全壳体处于其初始就位位置，这是由于其还没有经由导管推进组件40的远侧推进而被向远侧推进)，弹簧臂1260的自由端还不能就位在袋1266中。然而，一旦将向远侧推进导管42一定的增量距离，附接的安全壳体54不再阻止弹簧臂1260向下移动，并且弹簧臂的自由端就位入针衬套1214的袋1266。导丝推进组件20进一步远侧移动通过将指垫1218撞击在狭槽1236的远端上而被阻止，而近侧移动通过将弹簧臂就位在针衬套的袋1266中而被阻止。
注意，指垫1218在靠近其远端的其下侧包括突起1254，当完全向远侧推进指垫时，突起1254与限定在顶部壳体部分12A上的凹陷1252接合。这有助于将指垫1218保持就位在其远端位置，并且提供已经完全向远侧推进指垫的触觉提示。
还应当注意，如果将导管推进组件40向近侧移动回其初始位置(如图5所见)，则安全壳体54将再次邻接抵靠针衬套1214并且推动弹簧臂1260的自由端向上离开袋1266。这转而使得导丝推进组件20能够再次向近侧和向远侧移动，从而引起导丝22本身的相应的近侧和远侧推进。因此，在本实施方案中，导丝推进的锁定是可逆的。
在另一个实施方案中，应当明白，可以与导丝推进组件20一起包括推动按钮，以使得在最初发生导丝的锁定后，导丝能够被重新延伸或缩回(例如，比如经由按下按钮以使弹簧臂1260与针衬套的袋1266脱离)。因此设想了这些和其他变化。
易碎导丝机构
图8A至9C示出了导丝杆24的各种细节，导丝杆24形成导丝推进组件20的一部分并且被用于从插入工具的壳体12选择性地延伸导丝。根据本实施方案并且进一步如图8B和8C所示，导丝杆24包括易碎部分1400，其被配置为当导丝向近端缩回入插入工具10的壳体12时阻止向导丝施加过大的力。图8B和8C示出了本实施方案中的易碎部分1400包括连接部分1406，连接部分1406跨越间隙1412将导丝杆24的第一相对近侧部分1408连接至其第二相对远侧部分1410，间隙1412限定在相对近侧部分1408与相对远侧部分1410之间。连接部分1406被配置为当向其施加预定的张力时破碎。当临床医生使用过大的力移动导丝杆24以将导丝22缩回入壳体12时，可以施加这样的张力。在示例性情形中，施加这种过大的力包括当在导丝缩回期间，导丝卡在针16的远侧尖端16B上时。当在连接部分1406上施加张力时，连接部分的破碎阻止导丝22进一步缩回。这转而阻止导丝本身的可能的破碎，否则可能非期望地导致导丝的一部分栓塞入患者体内。
应当明白，一个或多个易碎部分1400及其一个或多个连接部分1406的各种尺寸、形状、位置、构造和数目均是可能的并且落入本发明的范围内。在一个实施方案中，如图8B至8C所示，近侧部分1408与远侧部分1412之间的间隙1412仅部分地横切导丝杆24，以便限定铰接部分1414。虽然铰接1414被示为活动铰接，但是应当明白，可以使用其他铰接接头，并且它们落入本发明的范围内。因此，当连接器1406破碎时，如本文描述的，近侧部分1408相对于远侧部分1410围绕铰接1414枢转。枢转移动可以吸收导丝杆24的任何继续移动以阻止导丝22的任何进一步移动。近侧部分1408的枢转移动还可以有意地错位并且阻碍导丝杆24的任何进一步的近侧移动和/或导丝22通过引导表面980的移动，从而进一步阻止导丝22的任何移动。对导丝杆24和相关联结构的移动的阻碍可以进一步指示临床医生已经产生了过大的力。
在一个实施方案中，如图9A至9C所示，间隙1412可以完全横切导丝杆24。导丝杆24的近侧部分1408和远侧部分1410可以借助于一个或多个连接器1406(例如，1406A、1406B)联接。如本文描述的，连接器1406A、1406B可以破碎，然后导丝杆24的近侧部分1408与远侧部分1410分隔，因此阻止导丝22的任何进一步移动，而与导丝杆24的任何后续移动无关。连接器1406A、1406B可以是间隔的关系，并且应当明白，连接器1406的任何数目和构造都落入本发明的范围内。
在实施方案中，连接器1406可以由与导丝杆24相同的材料形成，或由可以显示不同物理特性的不同的材料形成。连接器1406可以与导丝杆24形成为单个整体件。在实施方案中，连接器1406可以与导丝杆24单独形成，并且使用粘合剂、粘结、焊接或用于将连接器1406联接至导丝杆24的类似的合适技术附接至导丝杆。
血液闪现机构
图10至13描绘了与插入工具10的针16协作的血液闪现指示器(“指示器”)1500的各种实施方案。指示器1500经由通过指示器的血流确认针的远侧尖端期望地位于患者体内的静脉或其他载血(blood-carrying)脉管中。在实施方案中，如图10所示，指示器1500包括指示器管件1510，其包括通过其布置的内腔1512。针16包括限定在针16的壁中的孔1520，孔1520将针内腔1522与指示器管内腔1512流体连接。
在实施方案中，指示器管1510包括在其中形成的孔1514，孔1514从指示器管1510的第一侧壁1516延伸至第二侧壁1518并且横穿内腔1512。针16延伸通过指示器管孔1514，直到针孔1520与内腔1512对准。指示器管孔1514的内径小于针16的外径，使得在针16的外壁与孔1514的内壁之间形成密封，从而阻止流体泄漏。在实施方案中，当针16穿透并且横穿指示器管1510时，针16形成孔1514。指示器管件1510由材料比如硅橡胶等形成，从而可以接受针刺并且与其形成“自密封”密封件以便阻止泄漏。
在实施方案中，在插入工具的制造和组装期间，针16穿透并且被推进通过指示器管件1510。在另一个实施方案中，在使用期间，针16相对于插入工具10是可移动的。因此，当针16被部署时，针16横穿指示器管件1510，形成指示器管孔1514，直到针孔1520与指示器管内腔1512对准。
当针16的远侧尖端被布置在静脉中时，血液将向近侧流动通过针，通过孔1520，并且进入指示器管内腔1512，如箭头1530所指示。临床医生对指示器管件1510的目视检查将通过其中的血液的存在而确认远侧针尖被适当地定位。应当明白，在不脱离本发明的精神的情况下，指示器管1510、孔1520、1514等的尺寸、形状、位置和构造可以与所示不同。例如，针16可以包括两个孔1520a、1520b(未显示)，它们横穿针16的相对的壁并且各自与内腔1512流体连通。因此，血流1530可以沿着指示器管内腔1512在远离针16的两个方向上前进，从而提供针被期望地定位在患者的脉管系统中的附加指示器。此外，指示器管件1510由至少部分半透明材料形成，使得可以观察其中是否存在血液。
有利地，指示器1500的设计需要较少的部件即可将针16与指示器管1510连接。例如，不需要将针与指示器管流体连接的“鞍形”或类似部件。因此，提高了制造效率并降低了复杂性和相关成本。
在实施方案中，图11至13示出了与插入工具10的针16协作的血液闪现指示器(“指示器”)1500的更多细节。指示器管1510包括第一端1540，其被布置靠近针16和针孔1522。管第一端1540可以被布置在阀52内。然后，指示器管1510从阀52的近端延伸。在将导管插入患者体内期间，阀52被可移除地容纳在导管42的衬套46中。更多细节可见于2016年5月13日提交的U.S.2016/0256667，其在此通过引用以其整体并入本文。管1510从阀52的近端延伸，并且在把手组件1220(包括其翼部1280)内沿着曲折路径延伸。把手组件的部分(比如翼部1280)由半透明材料制成，使得可以观察到管1510。当针16的远侧尖端被布置在静脉中时，血液将向近侧流动通过针16，离开孔1520，并且经由布置在导管衬套42中的阀52进入指示器管件1510。血液继续沿着管件1510的长度在其曲折路径中流动通过翼部1280和把手组件1220，在此处对管件的目视检查将通过其中存在血液而确认远端针尖已经被适当定位。
图12C示出了根据本实施方案的当布置在翼部1280内的管件1510中存在血液时的插入工具10对于临床医生的外观的实施例。应当明白，在不脱离本发明的精神的情况下，指示器管件1510的尺寸、形状、位置和构造可以与所示不同。例如，如图13所示，管件1510可以延伸至插入工具的其他部分，在此处临床医生可以观察到管件1510。管件1510可以沿着工具10的表面延伸，或可以被布置在工具10的各种结构(比如壳体12)内。在实施方案中，工具10的各种部件(比如壳体12等)可以由半透明材料形成，使得可以观察到布置在其中的管1510。
导丝推进机构
图14A至18B示出了插入工具1600的示例性实施方案。插入工具1600包括导丝推进组件1610，用于使用临床医生的手指移动选择性地将导丝22从插入工具壳体向远侧推进。导丝推进组件1610包括壳体1612、导丝22和联接至导丝22的导丝推进器1624。壳体1612包括左侧部分1614、右侧部分1616和帽部分1618，它们协作以形成壳体1612并且包围导丝推进器1624。任选地，壳体1612的至少一部分由半透明材料形成。
壳体1612的左侧部分1614和右侧部分1616进一步包括划分结构1634，划分结构1634协作以将导丝推进器1624与壳体1612的内部部分气密分隔。应当明白，划分结构1634可以与壳体1612或其部分整体形成，或可以是装配在壳体1612内的单独结构，或它们的组合。壳体1612包括布置在其上表面中的开口1620，开口1620由分别在左侧部分1614和右侧部分1616中的凹部1621、1622形成。开口1620提供通向布置在壳体1612内的导丝推进器1624的一部分的通道。壳体1612进一步包括针结合袋1642，针结合袋1642与壳体1612的远侧开口1619纵向对准并且支撑针16的近端。针16从针结合袋1642通过开口1619延伸至在壳体1612的远端远侧的点。
在使用中，临床医生可以推进插入工具1600直到针16的远侧尖端16B进入患者的脉管系统。血液将沿着针16向近侧流动，从而形成如本文描述的血液闪现，并且填充壳体1612的内部部分。由于包括开口1620的导丝推进器1624与壳体1612的内部气密分隔，血液保持容纳在壳体1612内。此外，由于壳体1612可以由半透明材料形成，临床医生可以观察到血液闪现。壳体1612进一步包括例如位于壳体帽1618中的通气口1636。壳体帽1618包括阀，以在壳体的内部填充有血液时允许空气从壳体1612的内部部分逸出。阀还可以阻止任何血液从壳体逸出。因此，插入工具1600的壳体1612是血液闪回(flashback)指示器。在确认针16的远侧尖端16B位于患者的脉管系统中后，临床医生可以推进导丝22。临床医生可以使用手指或拇指借助于开口1620进入导丝推进器1624。临床医生可以向近侧或向远侧移动导丝推进器1624，这转而使与其联接的导丝22向近侧或远侧移动，如将在本文中更详细描述的。
图15A至15E示出了导丝推进器1624的各种视图。导丝推进器1624包括柔性轨道1626，柔性轨道1626包括顶表面和底表面并且从导丝推进器1624的近端延伸至远端。柔性轨道1626包括居中限定的狭缝1630，狭缝1630配置为使得轨道1626能够滑动经过，并且在针16、导管42、导丝22的任一侧或其组合上滑动，从而从插入工具壳体延伸。狭缝1630从柔性轨道1626的顶表面延伸至底表面，并且从远端延伸至在近端远侧的点。
柔性轨道1626包括布置在顶表面、底表面或其组合上的多个脊部1628。脊部1628垂直于插入工具10的纵向轴线延伸，并且以相对于彼此间隔的关系定位。此外，当从侧面轮廓观察时，并且如图15B至15C所示，布置在顶表面上的脊部1628相对于布置在底表面上的脊部1628以偏移关系间隔。有利地，脊部1628提供改进的摩擦，并且允许临床医生通过壳体1612中的开口1620抓握柔性轨道1624，并且允许导丝推进器1624滑动移动。此外，脊部1628的间隔和偏移关系允许柔性轨道1626沿着由纵向轴线和横向轴线限定的垂直平面挠曲。
导丝推进器1624进一步包括布置在其近端处的近侧块1632，近侧块1632与导丝22联接。近侧块1632被配置为当临床医生的手指向远侧滑动柔性轨道1626时，向远侧推动导丝22通过壳体1612的开口1619、通过针16和可移除地布置在针16上的导管42。
图16A示出了导丝推进组件1610的剖视图，示出了布置在其中的导丝推进器1624。柔性轨道1626向远侧延伸，并且其一部分通过开口1620暴露于临床医生。图16B示出了导丝推进器1624的预定路径1640，预定路径1640由左侧壳体部分1614和右侧壳体部分1616、划分结构1634或其组合限定。当临床医生向远侧推进导丝推进器1624时，其远侧部分被向下引导通过180°的弧度。狭缝1630允许柔性轨道1626经过针16、导管42和/或导丝22的任一侧。有利地，导丝推进组件1610通过允许临床医生在插入工具1600的远端附近握住插入工具1600而提供了对针16和导丝22的改进的控制。这为临床医生提供了对插入工具1600的定位的更好的控制，同时还允许单手控制导丝推进。
插入工具1600可以进一步包括针安全夹1650。安全夹1650包括底板1652(具有在其中布置的孔1656)和至少一个支撑臂，例如支撑臂1654A、1654B、1654C。支撑臂1654可以在打开状态(图17A、17C)与闭合状态(图17B、17D)之间挠曲。安全夹1650被布置在壳体1612的远端的远侧，并且容纳导管衬套46，从而将衬套46保持在支撑臂1654内，如图17E所示。支撑臂1654的远端中的每个包括止动器1662，止动器1662接合导管衬套46中的缺口1658，如图18A至18B所示，以进一步通过安全夹1650固定导管42。针16可以从针结合袋1642延伸，通过安全夹孔1656，并且通过导管42。
一旦导管被正确放置，如本文所讨论的，插入工具1600连同针16一起被缩回。导管42(其具有联接至其的安全夹1650)保持在适当位置并且向远侧滑动至针16的远侧尖端16B(图17F)。此时，安全夹1650与导管衬套46脱离，并且支撑臂1654围绕针尖16B闭合。支撑臂1654的远端彼此接合以围绕针尖16B锁定，从而将安全夹固定至其。一旦从导管42移除导丝推进组件1610，即阻止了意外的针刺伤。
方法
在示例性使用方法中，提供了导管插入工具，其包括具有易碎部分1400的导丝杆24、血液闪现指示器1500、血液闪现指示器壳体1612、导丝推进组件1610或它们的组合。临床医生使用一只手在远端附近处握住插入工具，将导管插入工具的针推进入患者的脉管系统。
当针16的远侧尖端16B进入脉管系统时，血液向近侧流动通过针内腔1522。血液可以借助于针孔1520进入指示器内腔1512。血液继续沿着插入工具的一部分(比如把手组件1220、翼部1280、壳体12、它们的组合等)内的曲折路径流动通过指示器内腔1512。插入工具10或指示器管1510的部分是半透明的和/或指示器管1510沿着插入工具的外表面的一部分延伸。此外，可以采用多个曲折路径向临床医生指示针尖已经被正确定位。在实施方案中，血液向近侧流动通过针内腔1522并且填充壳体1612，壳体的至少一部分是半透明的。然后，临床医生可以观察指示器管1510/壳体1612内是否存在血液以确认针尖被正确地定位在患者的脉管系统内。
在正确定位针尖的情况下，临床医生使用导丝推进组件1610推进导丝。临床医生使用一只手在插入工具的远端附近处握住插入工具并且使用导丝推进组件1610引导针进入脉管系统并且推进导丝。临床医生使用手指或拇指在远侧方向上移动导丝推进器1624的柔性轨道1626。柔性轨道1626的远端包括狭缝1630，狭缝1630允许柔性轨道1626的远端向下弯曲180°的弧并且经过导丝、导管和/或针组件的任一侧。
临床医生可以例如选择性地缩回导丝22，以确保其远侧尖端被正确地定位在患者的系统脉管内，或在导管放置后的移除插入工具期间选择性地缩回导丝22。当缩回导丝时，其远侧部分可能潜在地卡在针的远侧边缘上，比如针斜面。这转而可能导致导丝的远端部分切断，从而形成栓塞。为阻止这种情况，易碎连接器1406可以破碎，以阻止导丝在被卡住时进一步缩回。
本发明的实施方案可以在不偏离本公开文本的精神的情况下以其他具体形式实施。描述的实施方案在所有方面都应当被视为仅是说明性的而非限制性的。因此，实施方案的范围由所附权利要求指示而不是前面的说明书指示。在权利要求的等效物的意义和范围内的所有变化都包含在权利要求的范围内。

Claims (26)

1.一种用于将医疗装置插入患者体内的插入工具，所述插入工具包括：
壳体；
针；
推进组件，其配置为选择性地推进所述医疗装置，用于放置在所述患者体内；
导丝推进组件，其配置为在推进所述医疗装置之前，选择性地推进导丝，所述导丝推进组件包括：
第一部分；
第二部分，所述导丝可操作地附接至所述第一部分或所述第二部分中的一个；和
易碎部分，其将所述第一部分与所述第二部分物理地互连，所述易碎部分配置为当在其上施加预定大小的力时破碎。
2.根据权利要求1所述的插入工具，其中当所述易碎部分破碎时，所述导丝近侧缩回被基本上阻止。
3.根据权利要求1或2所述的插入工具，其中在所述易碎部分上施加的力是张力。
4.根据权利要求1至3中任一项权利要求所述的插入工具，其中所述力的所述预定大小小于使所述导丝破碎需要的力的第二预定大小。
5.根据权利要求1至4中任一项权利要求所述的插入工具，其中所述第一部分和所述第二部分通过所述易碎部分和铰接部分互连。
6.根据权利要求5所述的插入工具，其中当所述易碎部分破碎时，所述第一部分和所述第二部分围绕所述铰接部分相对于彼此枢转，所述第一部分和所述第二部分的枢转移动抑制所述导丝的进一步移动。
7.根据权利要求5所述的插入工具，其中当所述预定大小的力被施加在所述第一部分和所述第二部分上并且引起所述易碎部分破碎时，所述第一部分和所述第二部分彼此分离。
8.一种用于将医疗装置放置在患者的脉管系统内的插入工具，包括：
壳体；
指示器管，其包括指示器管内腔；和
针，其包括针内腔和布置在所述针的侧壁中的孔，所述孔使所述针内腔与所述指示器管内腔流体连接。
9.根据权利要求8所述的插入工具，其中所述指示器管延伸通过所述壳体的半透明部分。
10.根据权利要求9所述的插入工具，其中所述半透明部分是翼部，所述翼部用于将医疗装置推进入所述患者的所述脉管系统。
11.根据权利要求8所述的插入工具，其中所述指示器管沿着所述壳体的表面延伸。
12.根据权利要求8至11中任一项权利要求所述的插入工具，其中所述针包括通过所述针的所述侧壁的第二针孔，所述第二针孔与所述针孔相对布置。
13.根据权利要求12所述的插入工具，其中来自所述针的血流进入所述指示器管的所述内腔，并且沿着所述指示器管内腔以相反的方向流动离开所述针。
14.一种用于将导管放置在患者的脉管系统内的导管放置工具，所述导管放置工具包括：
壳体，其沿着纵向轴线延伸并且包括近端和远端；
导管，其包括导管衬套；
针；
针安全夹，所述针安全夹包括底板和一个或多个支撑臂，所述一个或多个支撑臂配置为将所述针安全夹可释放地固定至所述导管衬套；
导丝；和
导丝推进组件，其联接至所述导丝，所述导丝推进组件布置在所述壳体内，所述导丝推进组件的一部分借助于靠近所述壳体的所述远端的开口可进入。
15.根据权利要求14所述的导管放置工具，其中所述导丝推进组件包括导丝推进器和柔性轨道，当在远侧方向上推进所述柔性轨道时，所述柔性轨道通过所述壳体的所述开口是操作的，以在远侧方向上推进所述导丝。
16.根据权利要求15所述的导管放置工具，其中所述柔性轨道包括沿着纵向轴线延伸的狭缝，所述狭缝配置为允许所述导丝、所述导管或所述针中的至少一个穿过所述狭缝。
17.根据权利要求15或16所述的导管放置工具，其中当在远侧方向上推进所述导丝推进组件时，所述柔性轨道的远端行进通过基本上180°的弧。
18.根据权利要求14至17中任一项权利要求所述的导管放置工具，其中所述导丝推进组件与所述壳体的内部部分气密分隔。
19.根据权利要求18所述的导管放置工具，其中所述壳体包括所述壳体的半透明部分和所述内部部分，当所述针的远侧尖端进入所述患者的所述脉管系统时，所述壳体的所述内部部分填充有血液。
20.根据权利要求14至19中任一项权利要求所述的导管放置工具，其中所述一个或多个支撑臂各自包括止动器，所述止动器布置在所述一个或多个支撑臂中的每个的远端处并且配置为接合所述导管衬套中对应的缺口。
21.根据权利要求14至20中任一项权利要求所述的导管放置工具，其中所述针安全夹的所述底板包括孔，所述孔配置为可滑动地接合所述针。
22.一种放置医疗装置的方法，包括：
提供插入工具，所述插入工具包括：
壳体，其包括远端和近端，所述壳体包括半透明部分并且包括靠近所述远端的壳体开口，所述壳体开口在所述壳体的上表面上；
针，其从所述壳体的所述远端延伸，所述针包括从所述针的远端向近侧延伸的内腔；
导丝；
导丝推进组件，其布置在所述壳体内、可操作地附接至所述导丝并且通过所述壳体开口可进入；
医疗装置；
血液闪现指示器，所述血液闪现指示器与所述针内腔流体连接并且延伸通过所述壳体的所述半透明部分；
使用一只手靠近所述插入工具的远端抓握所述插入工具；
将所述针的所述远端推进入所述患者的脉管系统；
允许血液通过所述针内腔向近侧流动至所述血液闪现指示器；
通过所述壳体的所述半透明部分，观察所述血液闪现指示器中血液的存在；
使用一只手的手指通过所述壳体开口进入所述导丝推进组件并且在远侧方向上推进所述导丝推进组件而在远侧方向上推进所述导丝；和
沿着所述导丝推进医疗装置。
23.一种在放置导管后移除导管放置工具的方法，包括：
提供医疗装置放置工具，所述医疗装置放置工具包括：
导管，其包括导管衬套；
针；
针安全夹，其与所述针可滑动地接合并且可释放地固定至所述导管衬套；
导丝，其配置为在第一预定大小的力下破碎；和
导丝推进组件，其包括易碎连接部分，所述易碎连接部分配置为在第二预定大小的力下破碎；
使用所述导丝推进组件在近侧方向上缩回所述导丝；
从所述导管向近侧缩回所述针，使得所述针安全夹滑动至所述针的远端；和
当所述针安全夹到达所述针的远端时，使所述导管与所述针安全夹脱离。
24.根据权利要求23所述的方法，其中所述第一预定大小的力大于所述第二预定大小的力。
25.根据权利要求23或24所述的方法，其中所述针安全夹包括三个支撑臂，所述三个支撑臂配置为将所述针安全夹可释放地固定至所述导管衬套，所述三个支撑臂各自包括布置在其远端处的止动器，所述止动器配置为接合所述导管衬套中对应的缺口。
26.根据权利要求25所述的方法，其中当所述导管衬套从所述针安全夹释放时，所述三个支撑臂围绕针尖闭合。
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