CN112206397A - 导管插入装置的血液控制 - Google Patents
导管插入装置的血液控制 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/221—Frangible or pierceable closures within tubing
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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
- A61M25/0097—Catheters; Hollow probes characterised by the hub
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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
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
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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
- A61M25/065—Guide needles
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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
- A61M25/0693—Flashback chambers
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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
- A61M25/09—Guide wires
- A61M25/09041—Mechanisms for insertion of guide wires
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/24—Check- or non-return valves
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/24—Check- or non-return valves
- A61M2039/2426—Slit valve
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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
- A61M2207/00—Methods of manufacture, assembly or production
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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
Abstract
本发明公开了一种流体控制部件,该流体控制部件被构造用于在放入患者体内期间和之后控制流体流动穿过导管组件的轮毂。在一个实施方案中,流体控制部件包括设置在轮毂的腔体内的主体,该主体能够在第一位置和第二位置之间移动,其中主体当处于第一位置时不刺穿设置在轮毂中的阀,并且主体当处于第二位置时刺穿阀。主体包括:导管,当主体处于第二位置时,该导管使得流体能够流动穿过主体的内部;和多个纵向延伸的肋,该多个纵向延伸的肋设置在主体的外表面上。当主体处于第二位置时,所述肋在阀和主体的外部之间提供至少一个流体流动通道。
Description
分案信息
本申请是2017年9月12日递交的申请号为201780054901.0、发明名 称为“导管插入装置的血液控制”的发明专利申请的分案申请。
相关专利申请的交叉引用
本专利申请要求于2016年9月12日提交的名称为“BLOOD CONTROL FOR ACATHETER INSERTION DEVICE”的美国临时专利申请号 62/393,531的权益,该临时专利申请全文以引用方式并入本文中。
发明内容
简而言之,本发明的实施方案涉及一种用于辅助将导管或其他管状医 疗装置放置入患者体内的工具。具体地讲,公开了一种流体控制部件,该 流体控制部件被构造用于在放入患者体内期间和之后控制流体流动穿过导 管组件的轮毂。
在一个实施方案中,流体控制部件包括设置在轮毂的腔体内的主体, 该主体能够在第一位置和第二位置之间移动,其中主体当处于第一位置时 不刺穿设置在轮毂中的阀,并且主体当处于第二位置时刺穿该阀。主体包 括:导管,当主体处于第二位置时,该导管使流体能够流动穿过主体的内 部;以及多个纵向延伸的肋,该多个纵向延伸的肋设置在主体的外表面 上。当主体处于第二位置时,肋在阀和主体的外部之间提供至少一个流体 流动通道。
本发明的实施方案的这些和其他特征通过以下说明和所附权利要求书 将变得更加显而易见,或者可以通过如下文所示的本发明的实施方案的实 践而得以了解。
附图说明
将通过参照在附图中示出的本公开的具体实施方案给出对本公开的更 具体的描述。应当认识到,这些附图只是示出了本发明的典型实施方案, 因此不应视为限制其范围。将通过使用附图更加具体和详细地描述并且阐 释本发明的示例性实施方案,在这些附图中:
图1A和图1B是根据一个实施方案的导管插入装置的透视图;
图2是图1A和图1B的导管插入装置的分解图;
图3是根据一个实施方案的导管的横截面侧视图;
图4是图3的导管的血液控制部件的透视图;
图5A和图5B示出了图4的血液控制部件的各种视图;
图6A至图6C示出了根据一个实施方案的用于导管的血液控制部件的 各种视图;
图7A至图7C示出了图6A至图6C的导管和血液控制导管的使用的各 种视图;
图8A至图8F示出了图1A和图1B的导管插入装置的针毂的各种视 图;
图9是图1A和图1B的导管插入装置的闪光指示器的剖视图;
图10是图1A和图1B的导管插入装置的阀的透视图;并且
图11是示出穿刺图1A和图1B的导管插入装置的阀的血液控制部件 的隔离视图。
具体实施方式
现在参照附图,其中相似的结构将具有相似的参考标记。应当理解, 附图是本发明的示例性实施方案的图解和示意,而不是对本发明的限制, 也未必按比例绘制。
为了清楚起见,应当理解,词语“近侧”是指相对更靠近使用将在本文 中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,放置在患者的身体内的导管的端部被视为导管的远侧端部,而 留在体外的导管端部是导管的近侧端部。另外,如本文(包括权利要求 书)所用,词语“包括”、“具有”和“带有”应具有与词语“包含”相同的含义。
一般来讲,本发明的实施方案涉及一种用于辅助将导管或其他管状医 疗装置放置入患者体内的工具。例如,通常将各种长度的导管放置在患者 体内,以便建立到患者脉管的通路并且使得能够输注入药物或抽吸体液。 将在本文中描述的导管插入工具有利于此类导管放置。应注意,虽然下文 的论述集中于特定类型和相对较短长度的导管的放置,但多种类型、尺寸 和长度的导管可经由本装置插入,包括外周静脉中间或延长留置导管、PICC导管、中心静脉导管等。在一个实施方案中,可以放置长度介于约 1.25英寸与约2.25英寸之间的导管,但很多其他长度也是可能的。
图1A至图2示出了根据一个实施方案的有关通常用10表示的导管插 入工具(“插入工具”或“插入装置”)的各种细节。如图所示,插入工具10包 括外壳12,该外壳本身可包括近侧外壳部分12A和远侧外壳部分12B。外 壳12还包括开口远侧端部,并且可包括平坦底部,以使插入装置10能够 平放在表面上而不会倾斜。在另一个实施方案中,外壳是一体形成的。在 另一个实施方案中,可采用顶部外壳部分和底部外壳部分,或者可使用多 于两个部分。在本实施方案中,外壳由热塑性塑料诸如聚碳酸酯构成并且 是半透明的,但是也可以设想其他构型。外壳12在外壳的任一侧上限定抓 握表面13,如图1A和图1B所示,以使得能够由使用者抓握插入装置10。
在外壳12中包括支撑中空针16(在一个实施方案中一起形成针组件 的一部分)的针毂14。在本实施方案中,针毂14固定在外壳12内由外壳 限定的腔体13内,但在另一个实施方案中,针毂可与外壳一体形成。
如下文将进一步详细描述的,针毂14包括用于接收针16的一部分的 狭槽和一定量的粘合剂,诸如液体或UV固化粘合剂,以便将针固定在针 毂中的适当位置。针16从针毂14朝远侧延伸,以便延伸超过远侧外壳部 分12B的远侧端部并终止于其远侧端部16B处。凹口18被限定为穿过针 16的壁,靠近针的远侧端部。在导管插入程序期间,凹口18使得中空针 16一旦进入患者的脉管,血液便能够回流离开由中空针限定的管腔。因 此,离开凹口18的血液可被临床医生观察到,以确认针适当地放置在脉管 中,如下文将进一步说明。
包括导管管体44的导管42可移除地设置在位于外壳12外部的针16 的部分上,使得针占据由导管管体限定的导管的管腔。导管管体44从导管42的轮毂46朝远侧延伸,该轮毂最初设置为与远侧外壳部分12B的开口远 侧端部相邻,如图1A和图1B所示。
插入装置10还包括导丝推进组件20,以用于在针16进入血管后,将 导丝22推进穿过针并进入到患者的脉管系统中。导丝22(图1A至图2) 预先设置在针16的管腔中。导丝推进组件20包括导丝杆24,该导丝杆在 插入装置10的使用期间沿远侧方向选择性地推进导丝22,从而使得导丝的 远侧部分延伸超出针16的远侧端部16B。在本实施方案中,导丝杠杆24 的指垫28经由狭槽32可滑动地设置在外壳12上,以使得使用者的拇指和/ 或手指能够选择性地将导丝22朝远侧推进经过针16的远侧端部16B。当 然,也可使用将使用者输入转换成导丝移动的其他接合方案。在一个实施 方案中,导丝22可包括导丝支撑管,以为导丝提供附加刚度并便于上文所 述的远侧推进。在另一个实施方案中,导丝的近侧端部可附接在外壳12的 内部上的锚定点处(或插入装置10的其他固定部分)并且围绕导丝杠杆24 的近侧部分以大致U形的构型环绕,使得对于指垫28的每一个单位移动距 离,导丝的远侧端部朝远侧延伸超过针16的远侧端部16B两个单位的距 离。这些及其他修改形式因此可以被考虑。
在一个实施方案中,导丝的大部分长度包括通常称为镍钛诺的镍和钛 的金属合金,但也可采用其他合适的导丝材料。
图1A和图1B示出导管42可移除地附接到插入装置10,使得其导管 管体44设置在外壳12的远侧延伸的针16的部分的上方,使得导管位于插 入装置外壳的外部。本实施方案中的导管42通过与设置在外壳远侧端部上 的一个或多个特征部的摩擦配合而保持在抵靠外壳的开口远侧端部的适当 位置。突片48包括在导管毂46上,以用于在使用期间帮助使用者手动远 侧延伸导管42。
应注意,在一个实施方案中,针16和导管管体44的外径(和/或其他 区域)利用有机硅或其他合适的润滑剂进行润滑,以增强导管管体相对于 针的滑动并且有助于将导管插入患者体内。
插入装置10包括回缩系统,该回缩系统被构造成选择性地将针16回 缩到外壳12中。详细地讲,弹簧元件诸如螺旋弹簧50设置在外壳12的内 腔13的远侧端部和脊144之间,该脊设置在针毂14的近侧端部。弹簧50 围绕针毂14设置,并且针毂能够在外壳12的腔体内朝近侧滑动。针毂14 保持在外壳12的腔体内的远侧位置,其中弹簧通过设置在外壳12的远侧 端部附近的回缩按钮52保持处于压缩构型。手动按压回缩按钮52释放回 缩按钮与针毂14的接合,这继而使弹簧50膨胀,从而使针毂在外壳12的 腔体内朝近侧移动。这继而回缩针16,使得其远侧端部16B回缩到外壳12 中并且防止使用者无意地接触。需注意,也可采用其他针安全构造。
在此描述了将导管42放置在患者的脉管系统中的插入装置10的使 用。握住插入装置10的使用者首先在合适的插入部位引导针16的远侧部 分穿过皮肤并进入皮下血管。在确认针进入血管之后,致动导丝推进组件 20,其中指垫28(设置在外壳12中限定的狭槽32中)由使用者的手指推 进以朝远侧推进最初设置在中空针16内的导丝22(图1A)。需注意,导 丝22通过导丝杠杆24朝远侧推进,该导丝杠杆可操作地附接到可滑动的 指垫28。
导丝22的远侧推进持续进行直到指垫28朝远侧滑动预定距离,使得 导丝22的预定长度延伸超过针16的远侧端部,如图1A和图1B所示。这 将导丝22的远侧部分放置在血管内。
一旦导丝杠杆24通过指垫28的滑动而完全朝远侧延伸,该指垫使导 丝22延伸超过针16的远侧端部16B,使用导管毂46的突片48来手动朝远 侧推进导管42,这使得导管管体44在针16和导丝22的远侧部分上滑动并 经由插入部位进入患者的脉管系统中。根据这一点,应当理解,在本实施 方案中,指垫28用作用于推进导丝22的第一构件,而手动推进被用于推 进导管42。在另一个实施方案中,应当理解,指垫28也可被用于将导管 42朝远侧部署到血管中至少部分距离。
将导管42朝远侧推进,直到该导管适当地设置在患者的血管内。然 后,使用者手动按压外壳12上的回缩按钮52,这使弹簧50解压缩并回缩 针毂14,这继而使针16的远侧端部16B回缩到外壳12内并防止其再次出 现,从而保护使用者免受意外针刺。因此,这用作根据本实施方案的针安 全部件的一个示例;也可能采用其他部件。此时,导管42与外壳12物理 地分离。现在,在患者体内的适当位置,可根据标准程序准备导管42以供 使用和修整。然后可丢弃插入装置10。
更详细地,图2示出了根据一个实施方案的可与插入装置10一起使用 的连续血液闪光指示器80。闪光指示器80用于指示在装置10的使用期间 针16的管腔中血液的存在,从而确保针已经正确进入静脉或其他期望的输 送血液的血管中。如图9所示,闪光指示器80包括半透明腔室82,该半透 明腔室为大致圆柱形,在任一端处密封,并围绕针16的一部分设置,使得 针从任一密封端突出。在本实施方案中,闪光指示器80的腔室82设置在 外壳12内的针毂14的狭槽142(图8A至图8F)中,但也可能设置在沿着 针的其他位置。
两个凹口(第一凹口83和第二凹口84)限定在针16中,以便在针的 管腔和闪光指示器室的内部之间提供流体连通。在一个实施方案中,凹口 83、84代替凹口18(图2),并且在另一个实施方案中,除了凹口18之外 还包括这两个凹口。应当理解,在一个实施方案中,通过凹口18的血液通 道用作针的远侧端部16B已进入静脉的初始指示器,而此处所示的实施方 案用作附加指示器,以验证在初始进入后针远侧端部保持在静脉中。关于 闪光指示器80的更多细节可见于2016年5月13日提交的名称为“Catheter Placement DeviceIncluding an Extensible Needle Safety Component”的美国专 利申请No.15/154,384,该专利申请全文以引用方式并入本文。
在本实施方案中,导丝22穿过针16的管腔以便延伸穿过闪光指示器 80。第一凹口83设置在第二凹口84的远侧,朝向腔室82的远侧端部。
当通过针16的远侧端部16B实现血管通路时,血液朝近侧向上行进到 针的内表面和设置在针的管腔中的导丝22的外表面之间(图9)。在到达 针16中限定的相对较远侧的第一凹口83时,血液的一部分将穿过第一凹 口并进入腔室82。当血液充满半透明腔室82时,使用者可以通过插入装置 10的半透明外壳12观察腔室并观察其中的血液,从而确认已实现了血管通 路。在另一个实施方案中,外壳12可被构造成使得可以直接观察腔室82, 例如,在腔室和使用者之间没有插置居间结构。
第二凹口84用于为腔室82中的空气提供出口点,以平衡气压并使血 液能够通过第一凹口83继续进入腔室。需注意,在没有穿过第二凹口84 的血液通道的情况下,针16的内表面和导丝22的外表面之间的间隙使得 空气而非血液可在其间通过,从而使得腔室中的气压平衡。以这种方式, 闪光指示器80是连续指示器,使得血液连续流入腔室82,同时针远侧端部 16B设置在输送血液的血管内。
需注意,导管插入装置10可包括多于一个的闪光指示器。在一个实施 方案中并且如上所述,例如,可包括血液闪光指示器80,以及另一个闪光 指示器,诸如凹口18,其使得存在于针16的管腔中的血液能够朝近侧向上 行进到针的外表面和导管42的内表面之间的空间。
图3示出了根据一个实施方案的导管42包括的血液控制部件100的各 种细节。如图所示,血液部件100可滑动地设置在导管毂46的腔体46A 内,并且被构造成选择性地使流体能够与也设置在导管毂腔体内的阀102 一起流动穿过导管42。本实施方案中的阀102是三尖阀,该三尖阀包括由 多个狭缝103限定的三个小叶102A,如图10所示,但也可采用其他类型 的阀。
图4至图5B示出了血液控制部件100的各种细节,该血液控制部件包 括在近侧端部104A和远侧端部104B之间延伸并限定中心导管106的细长 主体104,流体可流动穿过该中心导管。多个肋110设置在主体104的外表 面上,使得肋从近侧经过主体的近侧端部104A纵向延伸到其远侧端部 104B。每个肋110从主体104径向延伸,以沿其纵向长度限定成型轮廓。 主体104和肋110有助于将血液控制部件100大致限定为圆锥形状。在其 他实施方案中,也可以偏离圆锥形状。
每个肋110还限定了沿着肋的纵向长度中间定位的凹口112,以及在 肋的近侧端部处的突出部114。如图3所示,每个肋110的凹口112接纳限 定在导管毂腔体46A的内表面上的环形脊120的一部分,以在致动之前将 血液控制部件100保持在腔体内的适当位置。相应地,当血液控制部件100 被致动时,每个肋110的突出部114与环形脊120接合,以便防止其进一 步远侧运动超过其预期的行进长度。主体104限定相邻的肋110之间的通 道126,从而在所示实施方案中提供四个流体流动通道。需注意,在一个实 施方案中,一个或多个肋110可沿其纵向长度偏移,使得包括突出部114 的肋的近侧部分不与肋的更远侧部分纵向对齐(如图5A和图5B中所 示),而是沿周向从肋的更远侧部分偏离。
图6A至图6C示出了根据另一个实施方案的血液控制部件100的细 节,其中主体104限定围绕导管106设置的多个通道126。中间环形肩部 128也由主体104限定。
图7A至图7C示出了图6A至图6C的血液控制部件100的各种操作阶 段,尽管此处描述的原理也适用于图4至图5B中所示的实施方案。具体地 讲,图7A和图7B示出了处于相对近侧位置(在本文中也称为未致动状 态)的血液控制部件100,其中环形脊120被接纳在血液控制部件的每个肋 110的凹口112内(在肩部128下方)。在该位置,主体104的远侧端部104B不突出穿过位于血液控制部件远侧的阀102,并因此根据需要没有流 体能够穿过导管42。因此,处于闭合位置的阀102防止血液通过导管42泄 漏,例如当导管已放置在患者体内但未与导管毂46进行外部连接时。
相比之下,图7C示出了处于相对远侧位置(在本文中也称为致动状 态)的血液控制部件100,其中血液控制部件已被远侧推进(诸如通过将公 鲁尔连接器插入导管毂46中),使得其远侧端部104B已穿过阀102的小 叶102A,从而通过血液控制部件的导管106提供穿过阀的流体路径。通过 突出部114与环形脊120的接合来防止血液控制部件100的进一步远侧推 进。如上所述,血液控制部件100的远侧运动是由鲁尔连接器或可以可操 作地连接到导管毂46的其他装置插入导管毂腔体46A中引起的。
根据本实施方案,血液控制部件100被构造成在血液控制部件在其致 动状态下刺穿阀之后消除血液控制部件和阀102之间的截留区域。具体而 言,并且相对于图4至图5B所示的实施方案,当血液控制部件刺穿阀时, 肋110引起阀102的小叶102A的额外变形,如图11所示。这继而防止小 叶102A部分密封到血液控制部件主体104的外表面,从而在它们之间提供 间隙,并且通过血液控制部件主体104的外表面和阀小叶之间的通道126 提供额外的流体流动路径。因此,流体能够流动穿过导管毂腔体46A,不 仅通过导管106流到血液控制部件主体104的内部,而且还通过通道126 流到血液控制部件主体的外部,所述通道通过肋110与阀小叶104A的相互 作用使其成为专利。血液控制部件100外部的这种流体流动有助于使流体 流动穿过整个毂腔46A,从而有利地防止血液控制部件100和阀102之间 的区域中的流体流动停滞。
需注意,在本实施方案中,形成小叶102A的每个狭缝103的外终止点 限定交错的终止点,如图11所示。还需注意,本文描述的肋仅是一个或多 个延伸表面的一个示例,所述一个或多个延伸表面可包括在血液控制部件 中,以使得额外的流体流动通道能够被限定在血液控制部件的外表面上, 以使得在血液控制部件刺穿阀时使流体能够围绕血液控制部件的外部流 动。其他延伸表面的示例包括凸块、环形表面、翅片等。因此,可设想这 些和其他实施方案。
图6A至图6C的血液控制部件100的操作类似于上文结合图4至图5B 所述的血液控制部件的操作,其中通道126除了导管106之外还提供流体 流动,以便防止血液控制部件100和阀102之间的流体流动停滞。
图8A至图8F示出了关于插入装置10的前述针毂14的各种细节,该 插入装置包括细长主体140,该细长主体在近侧端部140A和远侧端部 140B之间延伸。狭槽142沿主体140的长度纵向延伸,并且其尺寸被设定 成用于在其中接纳针16的长度的一部分。如上所述,脊144包括在针毂的 近侧端部140A上,并且提供一个表面,弹簧50可抵靠该表面使针毂回缩 并将针16附接到外壳12的腔体中。狭槽142限定了容积146,在该容积内 可接纳上述闪光指示器80。
需注意,狭槽142被构造成使得可接纳不同尺寸的针并将其固定在其 中。为此,狭槽142包括三个肩部148,以将针16支撑在狭槽142内。并 非每个肩部148的近侧边缘的形状都是相对倾斜的,以便防止放置在靠近 肩部的狭槽142中的液体环氧树脂粘合剂溢出,以用于将针16固定在狭槽 内。
本发明的实施方案可在不脱离本公开的实质的情况下体现为其他具体 形式。所述实施方案在所有方面均应视为仅是示例性的,而不是限制性 的。因此,这些实施方案的范围由所附权利要求书而非上述说明指出。属 于与权利要求书等同的意义和范围内的所有变化将被权利要求书的范围所 涵盖。
Claims (14)
1.一种制造导管组件的方法,包括:
形成导管,所述导管包括:
导管管体;和
导管毂,所述导管毂连接至所述导管管体的近侧端部,所述导管毂包括阀;
形成流体控制部件,所述流体控制部件包括:
导管,所述导管将所述流体控制部件的近侧端部中的近侧开口流体连接至所述流体控制部件的远侧端部中的远侧开口;和
多个纵向延伸的肋,所述多个纵向延伸的肋设置在所述流体控制部件的外表面上,所述肋中的每个从所述近侧端部延伸至远侧端部;和
将所述流体控制部件定位入所述导管毂,使得所述流体控制部件能够在如下位置之间移动:
第一位置,其中所述远侧端部定位在所述阀的近侧;和
第二位置,其中所述远侧端部定位在所述阀的远侧。
2.根据权利要求1所述的制造方法,其中所述阀包括三尖阀,所述三尖阀包括三个狭缝。
3.根据权利要求2所述的制造方法,其中每个狭缝的外终止点是交错的终止点。
4.根据权利要求1所述的制造方法,其中所述肋中的每个包括肩部,所述肩部在所述近侧端部和所述远侧端部之间的中间点处。
5.根据权利要求1所述的制造方法,其中所述流体控制部件具有大致锥形形状。
6.根据权利要求1所述的制造方法,其中所述导管毂包括在所述阀的近侧限定的环形脊,并且其中所述多个纵向延伸的肋中的每个包括在所述近侧端部和所述远侧端部之间的中间点处的凹口,在处于所述第一位置时,所述凹口接合所述环形脊。
7.根据权利要求6所述的制造方法,其中所述多个纵向延伸的肋中的每个还包括在所述近侧端部处的突出部,所述突出部构造成在处于所述第二位置时接合所述环形脊。
8.根据权利要求1所述的制造方法,其中所述多个纵向延伸的肋包括四个相等间隔开的纵向延伸的肋,所述四个相等间隔开的纵向延伸的肋围绕所述流体控制部件的周长。
9.根据权利要求1所述的制造方法,其中所述多个纵向延伸的肋中的每个向所述近侧开口的近侧延伸。
10.根据权利要求1所述的制造方法,其中所述流体控制部件还包括在所述多个纵向延伸的肋中的每个之间的流体流动通道。
11.一种用于导管插入装置的血液闪光指示器,包括:
针,所述针包括:
远侧尖锐尖端,所述远侧尖锐尖端包括远侧端部开口;
近侧部分,所述近侧部分包括在所述针的侧壁中的第一凹口和第二凹口,所述第一凹口和所述第二凹口经由针管腔与所述远侧端部开口流体连通;和
围绕所述第一凹口和所述第二凹口的半透明隔室,所述半透明隔室密封到所述针的外表面。
12.根据权利要求11所述的血液闪光指示器,其中所述导管插入装置包括针毂,所述针毂包括纵向延伸的狭槽,所述血液闪光指示器和所述针设置在所述纵向延伸的狭槽中。
13.根据权利要求12所述的血液闪光指示器,其中所述纵向延伸的狭槽包括构造成支撑所述针的多个肩部,其中近侧肩部包括近侧边缘,所述近侧边缘构造成当液体粘合剂被用于将所述针固定在所述狭槽中时防止所述粘合剂流出所述狭槽。
14.根据权利要求12所述的血液闪光指示器,其中所述针毂还包括径向延伸的脊,所述径向延伸的脊靠近所述针毂的近侧端部设置,所述脊构造成支撑所述导管插入装置的弹簧。
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- 2017-09-12 US US15/702,537 patent/US10493262B2/en active Active
- 2017-09-12 WO PCT/US2017/051214 patent/WO2018049413A1/en active Application Filing
- 2017-09-12 CN CN202011105345.5A patent/CN112206397B/zh active Active
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US20200094037A1 (en) | 2020-03-26 |
SG11201901968TA (en) | 2019-04-29 |
CN109715093A (zh) | 2019-05-03 |
CN109715093B (zh) | 2020-11-06 |
CN112206397B (zh) | 2023-03-21 |
EP3509513A4 (en) | 2020-06-10 |
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EP3509513A1 (en) | 2019-07-17 |
AU2017322745B2 (en) | 2021-09-23 |
AU2017322745A1 (en) | 2019-03-07 |
JP7051821B2 (ja) | 2022-04-11 |
US11759618B2 (en) | 2023-09-19 |
CN116173370A (zh) | 2023-05-30 |
CA3034478A1 (en) | 2018-03-15 |
JP2019526383A (ja) | 2019-09-19 |
US20180071509A1 (en) | 2018-03-15 |
US20230398345A1 (en) | 2023-12-14 |
WO2018049413A1 (en) | 2018-03-15 |
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