WO2024251018A1 - 穿刺器 - Google Patents

穿刺器 Download PDF

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Publication number
WO2024251018A1
WO2024251018A1 PCT/CN2024/096226 CN2024096226W WO2024251018A1 WO 2024251018 A1 WO2024251018 A1 WO 2024251018A1 CN 2024096226 W CN2024096226 W CN 2024096226W WO 2024251018 A1 WO2024251018 A1 WO 2024251018A1
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WO
WIPO (PCT)
Prior art keywords
puncture
puncture device
tip
accommodating
accommodating cavity
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2024/096226
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English (en)
French (fr)
Inventor
孙强
陈志�
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Touchstone International Medical Science Co Ltd
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Touchstone International Medical Science Co Ltd
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Filing date
Publication date
Application filed by Touchstone International Medical Science Co Ltd filed Critical Touchstone International Medical Science Co Ltd
Publication of WO2024251018A1 publication Critical patent/WO2024251018A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis, e.g. in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles

Definitions

  • Digestive tract diseases are one of the most common diseases in humans.
  • circular tubular staplers are often used to replace the doctor's manual operation to anastomose the digestive tract and other physiological tissues.
  • Circular tubular staplers are a common surgical instrument, most of which use axial internal stapling to form end-to-end or end-to-side anastomosis of physiological tissues such as the esophagus, stomach, and intestines during surgery.
  • a puncture device is generally provided for use in conjunction with the stapler.
  • the existing puncture device structure such as that disclosed in Chinese patent CN201492459U, is a rod-shaped structure, a puncture portion is provided at its proximal end, and a through hole is provided in the puncture portion.
  • the distal end of the puncture device is first connected to the anvil shaft of the circular tubular stapler, the proximal side of the puncture device pierces the tissue, the lead wire is passed into the through hole of the puncture device, and the lead wire is pulled by the hook needle to pull the puncture device out of the tissue stump. Then separate the puncture device from the anvil shaft, connect the anvil shaft to the body of the circular tubular stapler, and then perform the anastomosis operation of the circular tubular stapler.
  • the operator may use surgical scissors or the like to make a hole in a specific position in advance, use a lead wire to pass through the through hole on the puncture part, and guide the puncture device to extend out of the pre-punched hole through the lead wire.
  • the puncture part may accidentally puncture the tissue and cause tissue damage.
  • the purpose of the present application is to provide a puncture device, when the puncture device is not needed to puncture tissue, the tip portion can be adjusted to a storage state to avoid accidental damage. organize.
  • the present application provides a puncture device, which comprises:
  • a matching portion the matching portion being detachably connected to the anvil shaft of the circular tubular stapler;
  • the puncture part includes a tip part and a first connecting part, the tip part is connected to the accommodating part through the first connecting part, and the tip part has a puncture state exposed at the proximal end of the accommodating cavity and a storage state at least partially entering the accommodating cavity.
  • the first connection portion is rotatably connected to the inner wall of the accommodating cavity via a rotation axis; wherein the rotation axis is fixed to the outer wall of the first connection portion, or the rotation axis is fixed to the inner wall of the accommodating cavity.
  • the accommodating portion includes two fixed arms, the accommodating cavity is formed between the two fixed arms, and the first connecting portion is rotatably connected to the two fixed arms.
  • the puncture portion further includes a threading portion, in which a through hole is provided, and the threading portion and the tip portion are respectively connected to two ends of the first connection portion, and when the tip portion is in the puncture state, the threading portion at least partially enters the accommodating cavity.
  • the extension direction of the through hole is perpendicular to the axis of the puncture device.
  • the through hole includes an extension section, and when the tip portion is in the storage state, there is a first angle between the extension direction of the extension section and the axial direction of the puncture device, and the first angle is greater than or equal to 0° and less than 90°; there is a second angle between the extension direction of the extension section and the outer contour direction of the threading portion, and the second angle is greater than or equal to 0°.
  • the through hole also includes a guide section, which is connected to the distal end of the extension section, the opening of the guide section is located on the side wall of the first connecting portion, and the opening of the guide section is exposed to the accommodating portion, and the opening of the extension section is located at the center of one end of the threading portion away from the tip portion.
  • the first connecting portion includes a first surface and a second surface that are oppositely disposed, and the first surface and the second surface are rotatably connected to the fixed arm respectively;
  • the first connecting portion further includes a third surface, and the opening of the guide section is located on the third surface of the first connecting portion.
  • the proximal outer wall surface of the fixing arm is an inclined surface, and when the tip portion is in the puncture state, the proximal outer wall surface of the fixing arm and the outer wall surface of the tip portion have the same inclination angle.
  • the present application provides a new puncture device structure, in which the tip of the puncture portion is arranged to be in a retractable state.
  • the tip When the puncture device is needed to puncture tissue, the tip is in a puncture state, and it is exposed outside the accommodating cavity and can puncture tissue through the tip.
  • the tip When the puncture device is not needed to puncture tissue, the tip can be adjusted to a retracted state, and the tip is at least partially retracted in the accommodating cavity, and the tip will not contact the tissue, thereby effectively avoiding accidental damage to the tissue.
  • FIGS. 1 and 2 are schematic diagrams of the structure of a puncture device according to an embodiment of the present application, wherein the tip portion is in a puncture state;
  • FIG4 is a top view of a trocar according to an embodiment of the present application.
  • Fig. 5 is a cross-sectional view taken along the direction A1-A1 in Fig. 4;
  • FIG7 is an exploded view of a trocar according to another embodiment of the present invention.
  • FIG8 is a top view of a trocar according to another embodiment of the present invention.
  • FIG9 is a cross-sectional view taken along the direction A2-A2 in FIG8 ;
  • FIG. 10 is a schematic structural diagram of a stapler anvil assembly of a circular tubular stapler.
  • the tip portion also has a function of at least partially entering the housing cavity.
  • the storage state of the cavity means that when there is no need to use the puncture device to puncture the tissue, the tip portion can be adjusted to the storage state, and the tip portion is at least partially stored in the accommodating cavity, and the tip will not contact the tissue, thereby effectively avoiding accidental damage to the tissue.
  • the distal end and the proximal end are described by the distance relative to the operator after the puncture device is connected to the anvil shaft.
  • the distal end is the end away from the operator, that is, close to the surgical site
  • the proximal end is the end close to the operator, that is, away from the surgical site.
  • the puncture device 10 includes: a matching portion 1, the matching portion 1 is detachably connected to the anvil shaft 71 of the circular tubular stapler; a housing portion 3, which is arranged on the proximal side of the matching portion 1, and the housing portion 3 includes a housing cavity 31 opening toward the proximal side; a puncture portion 5, the puncture portion 5 includes a tip portion 51 and a first connecting portion 52, and the tip portion 51 is connected to the housing portion 3 through the first connecting portion 52.
  • the matching part 1 includes a tapered part 11 and a stepped part 12.
  • the proximal end of the anvil shaft 71 of the circular tubular stapler is provided with a structure adapted to the shape of the matching part 1, so that after the matching part 1 is inserted into the proximal end of the anvil shaft 71, when no external force is applied to remove it, the stability of the connection between the matching part 1 and the proximal end of the anvil shaft 71 can be maintained.
  • the puncture device 10 is guided to move out of the tissue by the guide wire, the anvil shaft 71 moves with the puncture device 10.
  • a cylindrical second connecting part 2 is also provided between the matching part 1 and the accommodating part 3, and the overall length of the puncture device 10 can be adjusted by adjusting the length of the second connecting part 2.
  • the tip portion 51 in the puncture state, is conical and its outer diameter gradually decreases from the distal end to the proximal end, so as to form a tip at the proximal end where stress is concentrated and can pierce tissue.
  • the tip portion 51 has a puncture state exposed at the proximal end of the accommodating cavity 31.
  • the tip portion 51 is in the puncture state, and it is exposed outside the accommodating cavity 31 and can pierce tissue with the tip.
  • the tip portion 51 also has a storage state in which at least part of the accommodating cavity 31 is entered.
  • the tip portion 51 can be stored.
  • the tip portion 51 is adjusted to the storage state, and the tip portion 51 is at least partially stored in the accommodating cavity 31, and its tip will not contact the tissue, thereby effectively avoiding accidental damage to the tissue.
  • the accommodating portion 3 includes two fixed arms 32, the accommodating cavity 31 is formed between the two fixed arms 32, and the first connecting portion 52 is rotatably connected to the two fixed arms 32.
  • the first connecting portion 52 includes a first surface and a second surface arranged opposite to each other, the first surface and the second surface are respectively provided with a rotating shaft 6, and the two fixed arms 32 are provided with a matching hole 321, and the rotating shaft 6 is embedded in the matching hole 321 and can rotate relative to the matching hole 321.
  • the tip portion 51 can be adjusted to switch between the puncture state and the storage state. For example, when the tip portion 51 is in the puncture state shown in FIG. 1 and FIG.
  • the matching hole 321 can be a blind hole opened on the inner wall of the fixed arm 32, or a through hole provided on the fixed arm 32.
  • the inner wall of the fixed arm 32 may be fixed with a rotating shaft, and a blind hole or a through hole may be provided in the first connecting portion 52, and the rotating shaft may be embedded in the blind hole or the through hole of the first connecting portion 52, and the first connecting portion 52 may rotate relative to the rotating shaft.
  • the fixed arm 32 may be an elastic arm with a certain elasticity, and during assembly, the rotating shaft 6 and the puncture portion 5 may be installed together in the fixed arm 32 as a whole, and the puncture portion 5 and the rotating shaft 6 may be integrally formed or separately formed and fixed to each other, and then the puncture portion 5 may be stably held therein by the clamping force of the elastic arm, and when the puncture portion 5 rotates until the tip portion 51 is in the puncture state or the storage state, the tip portion 51 may be kept stable in the current state by the elastic holding effect of the fixed arm 32 without applying an external force to make it continue to rotate.
  • the fixed arm 32 may also be a rigid arm, and after the puncture portion 5 is placed separately between the two fixed arms 32 , the rotating shaft is installed through the through hole on the fixed arm 32 .
  • the proximal outer wall surface of the fixing arm 32 is an inclined surface, and when the tip portion 51 is in the puncture state, the proximal outer wall surface of the fixing arm 32 is inclined at the same angle as the outer wall surface of the tip portion 51. Therefore, the outer wall surfaces of the proximal portions of the two fixing arms 32 gradually retract inward from the distal side to the proximal side, forming a smooth transition at the intersection of the tip portion 51, so that at this time, the outer surface of the entirety of the puncture portion 5 and the receiving portion 3 is Creates a streamlined appearance.
  • the puncture portion 5 further includes a threading portion 53, in which a through hole 4 is provided, and the threading portion 53 and the tip portion 51 are respectively connected to the two ends of the first connection portion 52, that is, the threading portion 53 is arranged at one end of the tip portion 51 away from the first connection portion 52.
  • the threading portion 53 When the tip portion 51 is in the puncture state, the threading portion 53 at least partially enters the accommodating cavity 31.
  • the tip portion 51 is in the storage state, the portion of the threading portion 53 provided with the through hole 4 is exposed to the accommodating cavity 31, or a certain operating space is formed between the threading portion 53 and the inner wall of the accommodating cavity 31.
  • the extending direction of the through hole 4 is perpendicular to the axis of the puncture device 10.
  • the tip portion 51 can be adjusted to the puncture state, and the tip portion 51 is used to puncture the tissue.
  • a surgical scissors or the like may be used to punch a hole in a specific position in advance, and a lead wire may be passed through the through hole 4 of the threading portion 53.
  • the lead wire may be used to guide the puncture device 10 to extend out of the pre-punched hole. During this process, it is required to avoid the tip portion 51 piercing the tissue, so the tip portion 51 needs to be kept in the retracted state.
  • FIG. 6 to 9 are schematic diagrams of the structure of the puncture device 10 of another embodiment of the present application, wherein the tip portion 51 shown in FIG. 6 is in a storage state.
  • the difference between this embodiment and the embodiment shown in FIG. 1 to 5 is that the structure of the through hole 4 in the threading portion 53 is different.
  • the through hole 4 includes a guide section 41 and an extension section 42.
  • the guide section 41 is connected to the first end of the extension section 42, the opening of the guide section 41 is located on the side wall of the first connecting portion 52, and the second end opening 43 of the extension section 42 is located at the center of the end of the threading portion 53 away from the tip portion 51, that is, when the tip portion 51 is in the storage state shown in FIG. 6, the second end opening 43 of the extension section 42 is located at the proximal center of the threading portion 53.
  • the extension direction of the extension section 42 is parallel to the axial direction S1 of the puncture device 10.
  • a first angle may be formed between the extension direction of the extension section 42 and the axial direction S1 of the puncture device 10, and the first angle is greater than or equal to 0° and less than 90°, that is, the extension direction of the extension section 42 may be parallel to the axial direction S1 of the puncture device 10, or there may be an acute angle between the extension direction of the extension section 42 and the axial direction S1 of the puncture device 10.
  • the first angle may further be selected to be less than or equal to 30°, but the present application is not limited thereto.
  • a second angle may be formed between the extension direction of the extension section 42 (in this embodiment, parallel to the axial direction S1 of the puncture device 10) and the outer contour 531 of the threading portion 53, and the second angle may be greater than or equal to 0° and less than 90°.
  • the included angle is greater than or equal to 0°, that is, the extending direction of the extension section 42 is parallel to the outer contour 531 direction of the threading portion 53 or forms an acute angle with the outer contour 531 direction of the threading portion 53.
  • the outer contour 531 of the threading portion 53 is conical, and in the cross section of the threading portion 53, the angle between the outer contour lines 531 on both sides of the threading portion 531 is less than 60°.
  • the first surface and the second surface of the first connecting portion 52 are respectively provided with the rotating shaft 6 or with a blind hole or a through hole matched with the rotating shaft 6, and the opening of the guide section 41 is located on the third surface of the first connecting portion 52, so that the opening of the guide section 41 is exposed to the accommodating portion 3, which is convenient for the operator to insert the lead wire from the opening of the guide section 41.
  • the puncture portion 5 can also rotate relative to the accommodating portion 3 to switch the tip portion 51 between the puncture state and the storage state.
  • extension direction of the extension section 42 is parallel to the axial direction of the puncture device 10 or has an acute angle with the axial direction of the puncture device 10, and is no longer perpendicular to the axial direction of the puncture device 10, when the lead wire is used for guiding and pulling out, the guide direction of the lead wire is closer to the axial direction of the puncture device 10, reducing the accidental deflection of the puncture portion 5 to the surroundings, thereby making it easier to pull the puncture device 10 out of the tissue.
  • the guide section 41 is a cone, and the inner diameter of the first end of the guide section 41 is larger than the inner diameter of the second end of the guide section 41.
  • the distal side of the guide section 41 includes a guide surface 411, and the guide surface 411 is inclined from the inside to the outside toward the distal side.
  • the guide surface 411 can be an inclined flat surface or a curved surface.
  • the guide section 41 can also adopt other structures, such as the distal surface of the guide section 41 is substantially perpendicular to the axial direction of the puncture device 10, etc., all of which belong to the protection scope of the present application.

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Abstract

本申请提供了一种穿刺器，所述穿刺器包括：配合部，所述配合部与圆管型吻合器的钉砧轴可拆卸地连接；容纳部，设置于所述配合部的近端侧，所述容纳部包括朝向近端侧方向开口的容纳腔；穿刺部，所述穿刺部包括尖端部和第一连接部，所述尖端部通过所述第一连接部连接于所述容纳部，且所述尖端部具有露出于所述容纳腔的近端的穿刺状态和至少部分进入所述容纳腔的收纳状态。本申请在无需使用穿刺器刺破组织时，可将所述尖端部调整至收纳状态，避免意外损伤组织。

Description

穿刺器 技术领域
本申请涉及医疗器械技术领域，具体涉及一种穿刺器。
背景技术
消化道疾病是人类高发的疾病之一，在治疗过程中，常使用圆管型吻合器代替医生的手工操作对消化道等生理组织进行吻合。圆管型吻合器是一种常见的外科手术器械，大多采用轴向内装订方式，在手术时对食管、胃、肠道等生理组织形成端对端的、或者端对侧的吻合。
在组织吻合的手术过程中，一般提供一个穿刺器与吻合器配合使用。现有的穿刺器结构例如中国专利CN201492459U中公开的，为一个杆状结构，其近端设有穿刺部，且穿刺部中开设有通孔。在使用时，先将穿刺器的远端与圆管型吻合器的钉砧轴相连接，穿刺器的近端侧刺穿组织，将引线传入穿刺器的通孔中，通过勾线针拉动引线，将穿刺器从组织残端中拉出。然后将穿刺器与钉砧轴分离，将钉砧轴与圆管型吻合器的本体相对接，即可进行圆管型吻合器的吻合操作。
在使用时穿刺器的另一种方式中，操作者也可使用手术剪刀等事先在特定的位置打孔，使用引线穿过穿刺部上的通孔，通过引线引导穿刺器从预先打的孔中伸出。在此过程中，穿刺部可能会意外刺破组织而造成组织损伤。
需要说明的是，上述背景技术部分公开的信息仅用于加强对本申请的背景的理解，因此可以包括不构成对本领域普通技术人员已知的现有技术的信息。
申请内容
针对现有技术中的问题，本申请的目的在于提供一种穿刺器，在无需使用穿刺器刺破组织时，可将所述尖端部调整至收纳状态，避免意外损伤 组织。
本申请实施例提供一种穿刺器，所述穿刺器包括：
配合部，所述配合部与圆管型吻合器的钉砧轴可拆卸地连接；
容纳部，设置于所述配合部的近端侧，所述容纳部包括朝向近端侧方向开口的容纳腔；
穿刺部，所述穿刺部包括尖端部和第一连接部，所述尖端部通过所述第一连接部连接于所述容纳部，且所述尖端部具有露出于所述容纳腔的近端的穿刺状态和至少部分进入所述容纳腔的收纳状态。
在一些实施例中，所述第一连接部可旋转地连接于所述容纳腔的内壁，所述尖端部处于所述穿刺状态且所述第一连接部相对于所述容纳部旋转时，所述尖端部进入所述收纳状态。
在一些实施例中，所述第一连接部通过旋转轴可旋转地连接于所述容纳腔的内壁；其中，所述旋转轴固定于所述第一连接部的外壁，或，所述旋转轴固定于所述容纳腔的内壁。
在一些实施例中，所述容纳部包括两个固定臂，所述两个固定臂之间形成所述容纳腔，所述第一连接部可旋转地连接于所述两个固定臂。
在一些实施例中，所述穿刺部还包括穿线部，所述穿线部中设有通孔，所述穿线部与所述尖端部分别连接于所述第一连接部的两端，所述尖端部处于所述穿刺状态时，所述穿线部至少部分进入所述容纳腔。
在一些实施例中，所述通孔的延伸方向垂直于所述穿刺器的轴心。
在一些实施例中，所述通孔包括延伸段，所述尖端部处于所述收纳状态时，所述延伸段的延伸方向与所述穿刺器的轴心方向之间具有第一夹角，所述第一夹角大于或等于0°，小于90°；所述延伸段的延伸方向与所述穿线部的外轮廓方向之间具有第二夹角，所述第二夹角大于或等于0°。
在一些实施例中，所述通孔还包括引导段，所述引导段连通于所述延伸段的远端，所述引导段的开口位于所述第一连接部的侧壁，且所述引导段的开口露出于所述容纳部，所述延伸段的开口设于所述穿线部远离所述尖端部的一端中心。
在一些实施例中，所述第一连接部包括相对设置的第一表面和第二表面，所述第一表面和所述第二表面分别可旋转地连接于所述固定臂；所述 第一连接部还包括第三表面，所述引导段的开口位于所述第一连接部的第三表面。
在一些实施例中，所述固定臂的近端外壁面为倾斜表面，且在所述尖端部处于所述穿刺状态时，所述固定臂的近端外壁面与所述尖端部的外壁面倾斜角度一致。
本申请所提供的穿刺器具有如下优点：
本申请提供了一种新的穿刺器结构，将穿刺部的尖端部设置成可收纳的状态，在需要使用穿刺器刺破组织时，尖端部处于穿刺状态，其露出于容纳腔外部可通过尖端刺破组织，在无需使用穿刺器刺破组织时，可将所述尖端部调整至收纳状态，尖端部至少部分收纳在容纳腔内，其尖端不会接触到组织，从而有效避免意外损伤组织。
附图说明
通过阅读参照以下附图对非限制性实施例所作的详细描述，本申请的其它特征、目的和优点将会变得更明显。
图1和图2是本申请一实施例的穿刺器的结构示意图，其中尖端部处于穿刺状态；
图3是本申请一实施例的穿刺器的结构示意图，其中尖端部处于收纳状态；
图4是本申请一实施例的穿刺器的俯视图；
图5是图4中A1-A1方向的剖视图；
图6是本申请另一实施例的穿刺器的结构示意图；
图7是本申请另一实施例的穿刺器的爆炸图；
图8是本申请另一实施例的穿刺器的俯视图；
图9是图8中A2-A2方向的剖视图；
图10是一种圆管型吻合器的钉砧组件的结构示意图。
附图标记：
10     穿刺器             42      延伸段
1      配合部             43      通孔的开口
11     锥形部              5       穿刺部
12     台阶部              51      尖端部
2      第二连接部          52      第一连接部
3      容纳部              53      穿线部
31     容纳腔              531     穿线部的外轮廓
32     固定臂              6       旋转轴
321    配合孔              70      圆管型吻合器的钉砧组件
4      通孔                71      钉砧轴
41     引导段              72      钉砧
411    引导面
具体实施方式
现在将参考附图更全面地描述示例实施方式。然而，示例实施方式能够以多种形式实施，且不应被理解为限于在此阐述的实施方式；相反，提供这些实施方式使得本申请将全面和完整，并将示例实施方式的构思全面地传达给本领域的技术人员。在图中相同的附图标记表示相同或类似的结构，因而将省略对它们的重复描述。说明书中的“或”、“或者”均可能表示“和”或者“或”。虽然本说明书中可使用术语“上”、“下”、“之间”等来描述本申请的不同示例性特征和元件，但是这些术语用于本文中仅出于方便，例如根据附图中所述的示例的方向。本说明书中的任何内容都不应理解为需要结构的特定三维方向才落入本申请的范围内。本说明书中虽然采用“第一”或“第二”等来表示某些特征，但其仅为表示作用，而不作为具体特征的数量和重要性的限制。
本申请提供了一种穿刺器，适用于与圆管型吻合器的钉砧组件配合使用，所述穿刺器包括：配合部，所述配合部与所述圆管型吻合器的钉砧轴可拆卸地连接；容纳部，设置于所述配合部的近端侧，所述容纳部包括朝向近端侧方向开口的容纳腔；穿刺部，所述穿刺部包括尖端部和第一连接部，所述尖端部通过所述第一连接部连接于所述容纳部。在需要使用穿刺器刺破组织时，尖端部处于露出于所述容纳腔的近端的穿刺状态，其可通过尖端集中作用力而刺破组织。所述尖端部还具有至少部分进入所述容纳 腔的收纳状态，在无需使用穿刺器刺破组织时，可将所述尖端部调整至收纳状态，尖端部至少部分收纳在容纳腔内，其尖端不会接触到组织，从而有效避免意外损伤组织。
在本申请中，远端和近端是以将所述穿刺器连接到钉砧轴后相对于操作者的远近来描述的，远端为远离操作者即靠近手术位置的一端，近端为靠近操作者即远离手术位置的一端。
下面结合附图介绍各个具体实施例的穿刺器的结构。可理解的是，各个附图和以下描述仅为示例。
图1～5为本申请一实施例的穿刺器10的结构示意图。在图4的视角中，左右方向即为穿刺器10的轴心方向，左侧为近端侧，右侧为远端侧。图10中示例性地示出了现有的一种圆管型吻合器的钉砧组件70的结构，钉砧组件70包括钉砧轴71和钉砧72。结合图1、图2和图10，在该实施例中，所述穿刺器10包括：配合部1，所述配合部1与所述圆管型吻合器的钉砧轴71可拆卸地连接；容纳部3，设置于所述配合部1的近端侧，所述容纳部3包括朝向近端侧方向开口的容纳腔31；穿刺部5，所述穿刺部5包括尖端部51和第一连接部52，所述尖端部51通过所述第一连接部52连接于所述容纳部3。所述配合部1包括锥形部11和台阶部12，所述圆管型吻合器的钉砧轴71的近端设有与所述配合部1的形状相适应的结构，以使得所述配合部1插入到所述钉砧轴71的近端后，在未施加将其移除的外力时，可以保持所述配合部1与所述钉砧轴71的近端连接的稳定性。在通过引线引导所述穿刺器10向组织外运动时，所述钉砧轴71随所述穿刺器10运动。所述配合部1和所述容纳部3之间还设有圆柱形的第二连接部2，通过调节所述第二连接部2的长度可调节所述穿刺器10的整体长度。
如图1和图2所示，在穿刺状态下，所述尖端部51为锥形且其从远端向近端外径逐渐减小，以在最近端形成一个应力集中而可刺破组织的尖端。所述尖端部51具有露出于所述容纳腔31的近端的穿刺状态，在需要使用穿刺器10刺破组织时，尖端部51处于穿刺状态，其露出于容纳腔31外部可通过尖端刺破组织。如图3所示，所述尖端部51还具有至少部分进入所述容纳腔31的收纳状态，在无需使用穿刺器10刺破组织时，可将 所述尖端部51调整至收纳状态，尖端部51至少部分收纳在容纳腔31内，其尖端不会接触到组织，从而有效避免意外损伤组织。
在该实施例中，所述容纳部3包括两个固定臂32，所述两个固定臂32之间形成所述容纳腔31，所述第一连接部52可旋转地连接于所述两个固定臂32。具体地，如图2和图5所示，在该实施例中，所述第一连接部52包括相对设置的第一表面和第二表面，所述第一表面和所述第二表面分别设有旋转轴6，所述两个固定臂32中设有配合孔321，所述旋转轴6嵌设于所述配合孔321中，且相对于所述配合孔321可旋转。通过旋转所述穿刺部5可调整所述尖端部51在穿刺状态和收纳状态之间切换。例如，所述尖端部51处于图1和图2示出的所述穿刺状态时，操作者手动操作所述第一连接部52，使所述穿刺部5相对于所述容纳部3旋转时，所述尖端部51可进入图3示出的收纳状态。所述配合孔321可以是开设在所述固定臂32的内壁的盲孔，也可以是设在所述固定臂32上的贯通孔。在另一种实施方式中，也可以所述固定臂32的内壁固定设有旋转轴，而在所述第一连接部52中设有盲孔或贯通孔，将所述旋转轴嵌设在所述第一连接部52的盲孔或贯通孔中，且所述第一连接部52可相对于所述旋转轴旋转。在一种实施方式中，所述固定臂32可以为具有一定弹性的弹性臂，在组装时可将所述旋转轴6和所述穿刺部5组成的整体一起安装于所述固定臂32中，所述穿刺部5与所述旋转轴6可以是一体成型或者分体成型而彼此固定，然后通过弹性臂的夹持力将所述穿刺部5稳定地保持在其中，并且在所述穿刺部5旋转至所述尖端部51处于穿刺状态或收纳状态时，在未施加使其继续旋转的外力的情况下，通过所述固定臂32的弹性保持作用，可以保持所述尖端部51稳定在当前状态。在另一可替代的实施方式中，所述固定臂32也可以为刚性臂，在将所述穿刺部5单独放入到两个固定臂32之间后，通过所述固定臂32上的通孔安装所述旋转轴。
如图1和图2所示，所述固定臂32的近端外壁面为倾斜表面，且在所述尖端部51处于所述穿刺状态时，所述固定臂32的近端外壁面与所述尖端部51的外壁面倾斜角度一致。因此，两个固定臂32的近端部分的外壁面从远端侧向近端侧逐渐向内缩进，在于所述尖端部51交接的地方形成一个平滑的过渡，使得此时所述穿刺部5和所述容纳部3整体的外表面 形成流线型外观。
如图3所示，在该实施例中，所述穿刺部5还包括穿线部53，所述穿线部53中设有通孔4，所述穿线部53与所述尖端部51分别连接于所述第一连接部52的两端，即所述穿线部53设置于所述尖端部51的远离所述第一连接部52的一端。所述尖端部51处于所述穿刺状态时，所述穿线部53至少部分进入所述容纳腔31。所述尖端部51处于收纳状态时，所述穿线部53设有通孔4的部分露出于所述容纳腔31，或与所述容纳腔31的内壁之间形成一定的操作空间。在该实施例中，所述通孔4的延伸方向垂直于所述穿刺器10的轴心。在使用该穿刺器10时，可以将尖端部51调整在穿刺状态，使用尖端部51刺破组织。或者也可以使用手术剪刀等事先在特定的位置打孔，使用引线穿过穿线部53的通孔4，通过引线引导穿刺器10从预先打的孔中伸出，此过程中要求避免尖端部51刺破组织，因此需要保持尖端部51在收纳状态。
图6～9为本申请另一实施例的穿刺器10的结构示意图，其中图6中示出的尖端部51处于收纳状态。该实施例与图1～5示出的实施例的区别在于：所述穿线部53中通孔4的结构不同。在该实施例中，所述通孔4包括引导段41和延伸段42，所述尖端部51处于图6示出的收纳状态时，所述引导段41连通于所述延伸段42的第一端，所述引导段41的开口位于所述第一连接部52的侧壁，所述延伸段42的第二端开口43设于所述穿线部53远离所述尖端部51的一端的中心，即所述尖端部51处于图6示出的收纳状态时，所述延伸段42的第二端开口43设于所述穿线部53的近端中心。如图9所示，所述尖端部51处于所述收纳状态时，所述延伸段42的延伸方向平行于所述穿刺器10的轴心方向S1。在其他实施方式中，所述延伸段42的延伸方向与所述穿刺器10的轴心方向S1之间也可形成第一夹角，所述第一夹角大于或等于0°，小于90°，即所述延伸段42的延伸方向可以平行于所述穿刺器10的轴心方向S1，或所述延伸段42的延伸方向与所述穿刺器10的轴心方向S1之间可以具有一个锐角夹角。所述第一夹角进一步可选为小于或等于30°，但本申请不限于此。所述延伸段42的延伸方向(在该实施例中平行于所述穿刺器10的轴心方向S1)与所述穿线部53的外轮廓531方向之间具有第二夹角，所述第二 夹角大于或等于0°，即所述延伸段42的延伸方向平行于所述穿线部53的外轮廓531方向或与所述穿线部53的外轮廓531方向形成一个锐角夹角。在该实施例中，所述穿线部53的外轮廓531为锥形，所述穿线部53的截面中，所述穿线部531的两侧外轮廓线531之间的角度小于60°。
在该实施例中，所述第一连接部52的第一表面和第二表面分别设有所述旋转轴6或设有与所述旋转轴6相配合的盲孔或贯通孔，所述引导段41的开口位于所述第一连接部52的第三表面，以使所述引导段41的开口露出于所述容纳部3，方便操作者将引线从引导段41的开口处穿入。该实施例中，所述穿刺部5同样可相对于所述容纳部3旋转，以将所述尖端部51在穿刺状态和收纳状态之间切换。并且，由于所述延伸段42的延伸方向平行于穿刺器10的轴心方向或与穿刺器10的轴心方向具有一个锐角夹角，而不再垂直于穿刺器10的轴向，使用引线进行引导拉出时，引线的引导方向与穿刺器10的轴心方向更接近，减少穿刺部5向周围的意外偏转，从而更容易将穿刺器10从组织中拉出。
图9所示，在该实施例中，所述引导段41为一锥形，且所述引导段41的第一端的内径大于所述引导段41的第二端的内径。所述尖端部51处于收纳状态时，所述引导段41的远端侧包括一引导面411，所述引导面411从内侧到外侧朝向远端侧方向倾斜，在将引线穿入所述通孔4中时，在所述引导面411的引导作用下，更容易将所述引线从引导段41的开口处引入，所述引导面411可以是一个倾斜的平直表面，也可以是一个弧面。在其他可替代的实施方式中，所述引导段41也可采用其他的结构，例如所述引导段41的远端面基本上垂直于所述穿刺器10的轴心方向等，均属于本申请的保护范围之内。
以上内容是结合具体的优选实施方式对本申请所作的进一步详细说明，不能认定本申请的具体实施只局限于这些说明。对于本申请所属技术领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干简单推演或替换，都应当视为属于本申请的保护范围。

Claims (10)

  1. 一种穿刺器，其特征在于，所述穿刺器包括：
    配合部，所述配合部与圆管型吻合器的钉砧轴可拆卸地连接；
    容纳部，设置于所述配合部的近端侧，所述容纳部包括朝向近端侧方向开口的容纳腔；
    穿刺部，所述穿刺部包括尖端部和第一连接部，所述尖端部通过所述第一连接部连接于所述容纳部，且所述尖端部具有露出于所述容纳腔的近端的穿刺状态和至少部分进入所述容纳腔的收纳状态。
  2. 根据权利要求1所述的穿刺器，其特征在于，所述第一连接部可旋转地连接于所述容纳腔的内壁，所述尖端部处于所述穿刺状态且所述第一连接部相对于所述容纳部旋转时，所述尖端部进入所述收纳状态。
  3. 根据权利要求2所述的穿刺器，其特征在于，所述第一连接部通过旋转轴可旋转地连接于所述容纳腔的内壁；
    其中，所述旋转轴固定于所述第一连接部的外壁，或，所述旋转轴固定于所述容纳腔的内壁。
  4. 根据权利要求2所述的穿刺器，其特征在于，所述容纳部包括两个固定臂，所述两个固定臂之间形成所述容纳腔，所述第一连接部可旋转地连接于所述两个固定臂。
  5. 根据权利要求4所述的穿刺器，其特征在于，所述穿刺部还包括穿线部，所述穿线部中设有通孔，所述穿线部与所述尖端部分别连接于所述第一连接部的两端，所述尖端部处于所述穿刺状态时，所述穿线部至少部分进入所述容纳腔。
  6. 根据权利要求5所述的穿刺器，其特征在于，所述通孔的延伸方向垂直于所述穿刺器的轴心。
  7. 根据权利要求5所述的穿刺器，其特征在于，所述通孔包括延伸段，所述尖端部处于所述收纳状态时，所述延伸段的延伸方向与所述穿刺器的轴心方向之间具有第一夹角，所述第一夹角大于或等于0°，小于90°；所述延伸段的延伸方向与所述穿线部的外轮廓方向之间具有第二夹角，所述第二夹角大于或等于0°。
  8. 根据权利要求7所述的穿刺器，其特征在于，所述通孔还包括引导段，所述引导段连通于所述延伸段的远端，所述引导段的开口位于所述第一连接部的侧壁，且所述引导段的开口露出于所述容纳部，所述延伸段的开口设于所述穿线部远离所述尖端部的一端中心。
  9. 根据权利要求8所述的穿刺器，其特征在于，所述第一连接部包括相对设置的第一表面和第二表面，所述第一表面和所述第二表面分别可旋转地连接于所述固定臂；所述第一连接部还包括第三表面，所述引导段的开口位于所述第一连接部的第三表面。
  10. 根据权利要求4所述的穿刺器，其特征在于，所述固定臂的近端外壁面为倾斜表面，且在所述尖端部处于所述穿刺状态时，所述固定臂的近端外壁面与所述尖端部的外壁面倾斜角度一致。
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CN216258581U (zh) * 2021-10-29 2022-04-12 四川轻化工大学 一种具有一体式针帽的安全型穿刺器
CN216535401U (zh) * 2021-11-30 2022-05-17 张继新 一种改良型管型吻合器
CN218684516U (zh) * 2022-05-21 2023-03-24 旭仁其木格 一种蒙医放血针
CN220089595U (zh) * 2023-06-06 2023-11-28 天臣国际医疗科技股份有限公司 穿刺器

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