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CN104546054A - Adjustable plugging device and release method - Google Patents

Adjustable plugging device and release method Download PDF

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Publication number
CN104546054A
CN104546054A CN201510026530.8A CN201510026530A CN104546054A CN 104546054 A CN104546054 A CN 104546054A CN 201510026530 A CN201510026530 A CN 201510026530A CN 104546054 A CN104546054 A CN 104546054A
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China
Prior art keywords
push rod
lower disc
flexible connector
disc
inner core
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Granted
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CN201510026530.8A
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CN104546054B (en
Inventor
李博
杨永森
陈娟
罗鹏
王超
李超
张芳芳
蒲忠杰
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Shanghai Shape Memory Alloy Material Co Ltd
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Shanghai Shape Memory Alloy Material Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • 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
    • 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
    • A61B2017/00575Implements 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 closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • 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
    • A61B2017/00575Implements 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 closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • 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
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00778Operations on blood vessels

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

本发明提供一种可调式封堵装置及释放方法,该封堵装置包括封堵器和推送杆,封堵器包括上盘片和下盘片,上盘片和下盘片之间设有弹性连接件,下盘片的下方设有下盘片结扎套,弹性连接件的活动端穿过下盘片结扎套与推送杆可拆卸连接,推送杆沿轴向拉动弹性连接件,调节弹性连接件在上盘片和下盘片之间的长度。该可调式封堵装置及释放方法,通过调节弹性连接件在上盘片和下盘片之间的长度,达到调节上盘片和下盘片之间的夹持力的目的,使封堵装置更稳定牢固,与病变位置贴合更良好,可以适应不同大小、不同长度的病变,同时该可调式封堵装置的可回收再释放性使得手术发生意外时可以纠正,降低了手术风险和手术操作难度。

The invention provides an adjustable blocking device and a release method. The blocking device includes a blocking device and a push rod. The blocking device includes an upper disk and a lower disk, and an elastic Connector, the lower disc is provided with a lower disc ligation sleeve, the movable end of the elastic connector passes through the lower disc ligation sleeve and is detachably connected with the push rod, and the push rod pulls the elastic connector along the axial direction to adjust the elastic connector The length between the upper and lower platters. The adjustable blocking device and release method achieve the purpose of adjusting the clamping force between the upper disk and the lower disk by adjusting the length of the elastic connecting piece between the upper disk and the lower disk, so that the blocking device It is more stable and firm, fits better with the lesion position, and can adapt to lesions of different sizes and lengths. At the same time, the adjustable occlusion device can be recovered and released so that it can be corrected when an accident occurs in the operation, reducing the risk of surgery and operation. difficulty.

Description

可调式封堵装置及释放方法Adjustable blocking device and release method

技术领域technical field

本发明涉及一种可调式封堵装置。The invention relates to an adjustable blocking device.

本发明还涉及一种可调式封堵装置的释放方法。The invention also relates to a method for releasing the adjustable blocking device.

背景技术Background technique

先天性心脏病主要是由于婴幼儿胚胎时期心腔内间隔封闭不全导致,针对这种缺损型病变,现行治疗方法主要是封闭治疗,包括外科缝合治疗以及介入的封堵治疗。Congenital heart disease is mainly caused by incomplete closure of the intracardiac septum during the embryonic period of infants and young children. For this defect-type lesion, the current treatment method is mainly closed treatment, including surgical suture treatment and interventional closure treatment.

在封堵治疗中,通常使用的封堵装置是蘑菇伞形封堵器或者弹簧圈,但蘑菇伞形封堵器在夹持力方面很难控制,而弹簧圈虽然可以控制夹持力,但不适用于大的缺损病变。现有一些设计的封堵盘片之间使用弹簧连接而不是传统的NiTi合金网连接,但弹簧长度固定,夹持力也是固定的,从而造成盘片对缺损周边的压迫是不可调节的,若应用在某些特殊病变例如室间隔缺损中时,会造成压迫水肿,严重时会造成三度传导阻滞(唯一的治疗方法是终身携带心脏起搏器)。In occlusion treatment, the commonly used occlusion devices are mushroom umbrella occluders or coils, but mushroom umbrella occluders are difficult to control in terms of clamping force, while spring coils can control clamping force, but Not suitable for large defect lesions. Some existing designs use spring connection instead of the traditional NiTi alloy mesh connection between the plugging disks, but the length of the spring is fixed, and the clamping force is also fixed, so that the compression of the disk on the periphery of the defect cannot be adjusted. When applied to some special lesions such as ventricular septal defect, it will cause compression edema, and in severe cases, it will cause third-degree conduction block (the only treatment is to carry a pacemaker for life).

发明内容Contents of the invention

鉴于以上所述现有技术的缺点,本发明的目的在于提供一种可调式封堵装置及释放方法,用于解决现有技术中封堵装置的夹持力难以控制、不可调的问题。In view of the above-mentioned shortcomings of the prior art, the object of the present invention is to provide an adjustable blocking device and a release method to solve the problem in the prior art that the clamping force of the blocking device is difficult to control and cannot be adjusted.

为实现上述目的及其他相关目的,本发明提供一种可调式封堵装置,该封堵装置包括封堵器和推送杆,封堵器包括上盘片和下盘片,上盘片、下盘片由形状记忆丝线网状编织而成,上盘片和下盘片之间设有弹性连接件,弹性连接件设有与上盘片固定的固定端和穿过下盘片的活动端,下盘片的下方设有下盘片结扎套,弹性连接件的活动端穿过下盘片结扎套与推送杆可拆卸连接;推送杆沿轴向拉动弹性连接件,调节弹性连接件在上盘片和下盘片之间的长度;推送杆与弹性连接件脱离时,弹性连接件的活动端与下盘片结扎套的相对位置保持不变。In order to achieve the above purpose and other related purposes, the present invention provides an adjustable occlusion device, the occlusion device includes an occluder and a push rod, the occluder includes an upper disk and a lower disk, the upper disk, the lower disk The disc is woven by shape memory wire mesh. There is an elastic connector between the upper disc and the lower disc. The elastic connector is provided with a fixed end fixed to the upper disc and a movable end passing through the lower disc. There is a lower disc ligation sleeve under the disc, and the movable end of the elastic connector is detachably connected with the push rod through the lower disc ligation sleeve; the push rod pulls the elastic connector along the axial direction, and adjusts the elastic connector on the upper disc. and the length between the lower disc; when the push rod is separated from the elastic connector, the relative position of the movable end of the elastic connector and the lower disc ligation sleeve remains unchanged.

优选的,推送杆包括推送杆外壳、推送杆内芯,推送杆内芯在推送杆外壳的内腔内沿轴线移动或旋转,推送杆外壳的端部与下盘片结扎套可拆卸连接,推送杆内芯的端部与弹性连接件的活动端可拆卸连接。Preferably, the push rod includes a push rod shell and a push rod inner core, the push rod inner core moves or rotates along the axis in the inner chamber of the push rod shell, the end of the push rod shell is detachably connected to the lower disc ligation sleeve, and the push rod The end of the rod inner core is detachably connected to the movable end of the elastic connector.

进一步的优选,推送杆外壳的端部与下盘片结扎套螺纹连接。Further preferably, the end of the push rod housing is threadedly connected to the lower disk ligature sleeve.

进一步的优选,推送杆内芯的端部与弹性连接件的活动端螺纹连接或通过夹扣连接。Further preferably, the end of the inner core of the push rod is threadedly connected to the movable end of the elastic connector or connected through a clip.

优选的,弹性连接件为弹簧。Preferably, the elastic connecting member is a spring.

进一步的优选,弹簧的活动端设有弹簧限位头部,弹簧限位头部的外径大于下盘片结扎套的内径。Further preferably, the movable end of the spring is provided with a spring limiting head, and the outer diameter of the spring limiting head is larger than the inner diameter of the lower disc ligation sleeve.

进一步的优选,弹簧为圆柱状标准弹簧、方形弹簧、椭圆弹簧或圆锥状弹簧。Further preferably, the spring is a cylindrical standard spring, square spring, elliptical spring or conical spring.

优选的,弹性连接件为管形网状编织结构,管形网状编织结构由形状记忆丝线网状编织而成。Preferably, the elastic connector is a tubular mesh braided structure, and the tubular mesh braided structure is braided by shape memory wires.

进一步的优选,管形网状编织结构的活动端设有编织结构结扎套,编织结构结扎套能穿过下盘片插入下盘片结扎套中,编织结构结扎套远离管形网状编织结构的一端设有结扎套限位头部,结扎套限位头部的外径大于下盘片结扎套的内径,管形网状编织结构靠近编织结构结扎套的一端设有沿径向伸展的伸展翼,伸展翼的外径大于下盘片结扎套的内径。Further preferably, the movable end of the tubular mesh braided structure is provided with a braided structure ligation sleeve, the braided structure ligation sleeve can be inserted into the lower disc ligation sleeve through the lower disc, and the braided structure ligation sleeve is away from the bottom of the tubular mesh braided structure. One end is provided with a ligation sleeve limiting head, the outer diameter of the ligation sleeve limiting head is larger than the inner diameter of the lower disc ligation sleeve, and the end of the tubular mesh braided structure close to the braided structure ligation sleeve is provided with an extension wing extending radially , the outer diameter of the stretched wings is greater than the inner diameter of the lower disc ligature sleeve.

为实现上述目的及其他相关目的,本发明还提供一种使用上述可调式封堵装置的释放方法,包括以下步骤:In order to achieve the above purpose and other related purposes, the present invention also provides a release method using the above adjustable occlusion device, comprising the following steps:

1)将推送杆与封堵器连接,拉动推送杆,将封堵器拉入输送鞘管内;1) Connect the push rod to the occluder, pull the push rod, and pull the occluder into the delivery sheath;

2)通过输送鞘管,将封堵器送至病变位置;2) Send the occluder to the lesion position through the delivery sheath;

3)推送推送杆外壳,将上盘片释放;3) Push the push rod shell to release the upper disc;

4)同时推送推送杆外壳与推送杆内芯,释放弹性连接件;4) Simultaneously push the outer shell of the push rod and the inner core of the push rod to release the elastic connector;

5)推送杆内芯保持不动,推送推送杆外壳,下盘片部分释放;5) Keep the inner core of the push rod still, push the outer shell of the push rod, and release the lower disc part;

6)将推送杆外壳与下盘片结扎套分离;6) Separate the push rod shell from the lower disc ligation sleeve;

7)观察封堵器是否稳定牢固,若有需要,调节弹性连接件在上盘片和下盘片之间的长度;7) Observe whether the occluder is stable and firm, and if necessary, adjust the length of the elastic connector between the upper disc and the lower disc;

8)抽回推送杆外壳,推送杆内芯与弹性连接件外露且完全释放;8) Pull back the outer shell of the push rod, and the inner core of the push rod and the elastic connector are exposed and completely released;

9)将推送杆内芯与弹性连接件的活动端分离。9) Separate the inner core of the push rod from the movable end of the elastic connector.

优选的,所述步骤1)包括以下步骤:Preferably, said step 1) comprises the following steps:

①将弹性连接件的活动端与推送杆内芯的端部连接;① Connect the movable end of the elastic connector to the end of the inner core of the push rod;

②将推送杆内芯连同弹性连接件的活动端一起拉入推送杆外壳中;② Pull the inner core of the push rod together with the movable end of the elastic connector into the outer shell of the push rod;

③将推送杆外壳与下盘片结扎套固定连接;③Fixly connect the push rod shell with the lower disc ligation sleeve;

④推送杆内芯连同弹性连接件的活动端,在推送杆外壳的空腔内沿轴线移动或旋转,调节弹性连接件在上盘片和下盘片之间的长度;④The inner core of the push rod and the movable end of the elastic connector move or rotate along the axis in the cavity of the push rod shell to adjust the length of the elastic connector between the upper disc and the lower disc;

⑤拉动推送杆,将封堵器拉入输送鞘管内。⑤ Pull the push rod to pull the occluder into the delivery sheath.

优选的,步骤7)中调节弹性连接件在上盘片和下盘片之间的长度的过程包括以下步骤:Preferably, the process of adjusting the length of the elastic connector between the upper disk and the lower disk in step 7) includes the following steps:

①将推送杆外壳前推,使推送杆内芯与弹性连接件回收到推送杆外壳的内腔内;①Push the push rod shell forward, so that the push rod inner core and the elastic connector are recovered into the inner cavity of the push rod shell;

②将推送杆外壳与下盘片结扎套固定连接;②Fixly connect the push rod shell with the lower disc ligation sleeve;

③将推送杆内芯及弹性连接件的活动端一起在推送杆外壳的空腔内沿轴线移动或旋转,调节弹性连接件在上盘片和下盘片之间的长度;③Move or rotate the inner core of the push rod and the movable end of the elastic connector along the axis in the cavity of the push rod shell, and adjust the length of the elastic connector between the upper disc and the lower disc;

④将推送杆外壳与下盘片结扎套分离。④ Separate the push rod shell from the lower disc ligation sleeve.

如上所述,本发明可调式封堵装置及释放方法,具有以下有益效果:As mentioned above, the adjustable blocking device and release method of the present invention have the following beneficial effects:

该可调式封堵装置及释放方法,通过调节弹性连接件在上盘片和下盘片之间的长度,达到调节上盘片和下盘片之间的夹持力的目的,使封堵装置更稳定牢固,与病变位置贴合更良好,可以适应不同大小、不同长度的病变,同时该可调式封堵装置的可回收再释放性使得手术发生意外时可以纠正,降低了手术风险和手术操作难度。The adjustable blocking device and release method achieve the purpose of adjusting the clamping force between the upper disk and the lower disk by adjusting the length of the elastic connecting piece between the upper disk and the lower disk, so that the blocking device It is more stable and firm, fits better with the lesion position, and can adapt to lesions of different sizes and lengths. At the same time, the adjustable occlusion device can be recovered and released so that it can be corrected when an accident occurs in the operation, reducing the risk of surgery and operation. difficulty.

附图说明Description of drawings

图1显示为本发明的可调式封堵装置的结构示意图。Fig. 1 is a schematic structural diagram of the adjustable blocking device of the present invention.

图2显示为图1所示的可调式封堵装置的封堵器的第一种具体实施方式的结构示意图。Fig. 2 is a schematic structural diagram of a first embodiment of the occluder of the adjustable occlusion device shown in Fig. 1 .

图3显示为图1所示的可调式封堵装置的封堵器的第二种具体实施方式的结构示意图。Fig. 3 is a schematic structural diagram of a second embodiment of the occluder of the adjustable occlusion device shown in Fig. 1 .

图4显示为图1所示的可调式封堵装置的封堵器的第三种具体实施方式的结构示意图。Fig. 4 is a schematic structural diagram of a third embodiment of the occluder of the adjustable occlusion device shown in Fig. 1 .

图5显示为图1所示的可调式封堵装置的封堵器的第四种具体实施方式的结构示意图。Fig. 5 is a schematic structural diagram of a fourth embodiment of the occluder of the adjustable occlusion device shown in Fig. 1 .

图6显示为图1所示的可调式封堵装置的封堵器的第五种具体实施方式的结构示意图。Fig. 6 is a schematic structural diagram of a fifth embodiment of the occluder of the adjustable occlusion device shown in Fig. 1 .

图7a至图7b显示为图1所示的可调式封堵装置的封堵器的第六种具体实施方式的结构示意图。Fig. 7a to Fig. 7b are schematic structural diagrams of a sixth embodiment of the occluder of the adjustable occlusion device shown in Fig. 1 .

图8a至图8b显示为图1所示的可调式封堵装置的封堵器的第七种具体实施方式的结构示意图。Fig. 8a to Fig. 8b are schematic structural diagrams of a seventh embodiment of the occluder of the adjustable occlusion device shown in Fig. 1 .

图9a至图9f显示为图1所示的可调式封堵装置的推送杆的第一种具体实施方式的结构示意图。Fig. 9a to Fig. 9f are schematic diagrams showing the structure of the first embodiment of the push rod of the adjustable blocking device shown in Fig. 1 .

图10显示为图1所示的可调式封堵装置的推送杆的第二种具体实施方式的结构示意图。Fig. 10 is a schematic structural diagram of a second embodiment of the push rod of the adjustable blocking device shown in Fig. 1 .

元件标号说明Component designation description

1              封堵器1 occluder

11             上盘片11 Upper platter

12             下盘片12 Lower platter

121            下盘片结扎套121 Lower disc ligation set

13             弹性连接件13 Elastic connectors

131            弹簧131 spring

132            弹簧限位头部132 Spring limit head

133            管形网状编织结构133 Tubular mesh braided structure

134            编织结构结扎套134 Braided structure ligature set

135            结扎套限位头部135 Ligation sets limit the head

136            伸展翼136 Extended Wings

14             腰部14 Waist

2              推送杆2 push lever

21             推送杆外壳21 Push lever housing

22             推送杆内芯22 Push rod inner core

23             夹扣23 Clips

3              输送鞘管3 Delivery sheath

具体实施方式Detailed ways

以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效。The implementation of the present invention will be illustrated by specific specific examples below, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

请参阅图1至图10。须知,本说明书所附图式所绘示的结构、比例、大小等,均仅用以配合说明书所揭示的内容,以供熟悉此技术的人士了解与阅读,并非用以限定本发明可实施的限定条件,故不具技术上的实质意义,任何结构的修饰、比例关系的改变或大小的调整,在不影响本发明所能产生的功效及所能达成的目的下,均应仍落在本发明所揭示的技术内容得能涵盖的范围内。同时,本说明书中所引用的如“上”、“下”、“左”、“右”、“中间”及“一”等的用语,亦仅为便于叙述的明了,而非用以限定本发明可实施的范围,其相对关系的改变或调整,在无实质变更技术内容下,当亦视为本发明可实施的范畴。See Figures 1 through 10. It should be noted that the structures, proportions, sizes, etc. shown in the drawings attached to this specification are only used to match the content disclosed in the specification, for those who are familiar with this technology to understand and read, and are not used to limit the implementation of the present invention. Limiting conditions, so there is no technical substantive meaning, any modification of structure, change of proportional relationship or adjustment of size, without affecting the effect and purpose of the present invention, should still fall within the scope of the present invention. The disclosed technical content must be within the scope covered. At the same time, terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit this specification. The practicable scope of the invention and the change or adjustment of its relative relationship shall also be regarded as the practicable scope of the present invention without any substantial change in the technical content.

如图1至图10所示,本发明提供一种可调式封堵装置,该封堵装置包括封堵器1和推送杆2,封堵器1包括上盘片11和下盘片12,上盘片11、下盘片12由形状记忆丝线网状编织而成,上盘片11和下盘片12之间设有弹性连接件13,弹性连接件13设有与上盘片11固定的固定端和穿过下盘片12的活动端,下盘片12的下方设有下盘片结扎套121,弹性连接件13的活动端穿过下盘片结扎套121与推送杆2可拆卸连接;推送杆2沿轴向拉动弹性连接件13,调节弹性连接件13在上盘片11和下盘片12之间的长度;推送杆2与弹性连接件13脱离时,弹性连接件13的活动端与下盘片结扎套121的相对位置保持不变。上述封堵装置,通过推送杆2沿轴向拉动弹性连接件13,调节弹性连接件13在上盘片11和下盘片12之间的长度,从而调节上盘片11和下盘片12之间的夹持力,使封堵装置更稳定牢固,与病变位置贴合更良好,可以适应不同大小、不同长度的病变。As shown in Figures 1 to 10, the present invention provides an adjustable occlusion device, the occlusion device includes an occluder 1 and a push rod 2, the occluder 1 includes an upper disk 11 and a lower disk 12, the upper The disc 11 and the lower disc 12 are made of shape-memory wire mesh weaving. An elastic connector 13 is arranged between the upper disc 11 and the lower disc 12. end and the movable end passing through the lower disc 12, the lower disc 12 is provided with a lower disc ligation sleeve 121, and the movable end of the elastic connector 13 passes through the lower disc ligation sleeve 121 and is detachably connected with the push rod 2; The push rod 2 axially pulls the elastic connector 13 to adjust the length of the elastic connector 13 between the upper disk 11 and the lower disk 12; when the push rod 2 is separated from the elastic connector 13, the movable end of the elastic connector 13 The relative position with the lower disc ligation sleeve 121 remains unchanged. The above-mentioned blocking device pulls the elastic connecting piece 13 in the axial direction through the push rod 2 to adjust the length of the elastic connecting piece 13 between the upper disk 11 and the lower disk 12, thereby adjusting the distance between the upper disk 11 and the lower disk 12. The clamping force between them makes the occlusion device more stable and firm, and fits better with the lesion position, and can adapt to lesions of different sizes and lengths.

如图2至图6所示,弹性连接件13为弹簧131。其中,弹簧131的活动端设有弹簧限位头部132,弹簧限位头部132的外径大于下盘片结扎套121的内径。弹簧限位头部132用于连接弹簧131与推送杆2,同时也使推送杆2与弹簧131脱离时,弹簧131不会缩回到下盘片结扎套121中去。As shown in FIGS. 2 to 6 , the elastic connecting member 13 is a spring 131 . Wherein, the movable end of the spring 131 is provided with a spring limiting head 132 , and the outer diameter of the spring limiting head 132 is larger than the inner diameter of the lower disc ligation sleeve 121 . The spring limiting head 132 is used to connect the spring 131 and the push rod 2 , and at the same time, when the push rod 2 is separated from the spring 131 , the spring 131 will not retract into the lower disc ligation sleeve 121 .

如图2所示,上盘片11和下盘片12之间除了弹簧131连接外,还通过腰部14连接,腰部14由形状记忆丝线网状编织而成,将弹簧131围在中间。这种设计使在调节上盘片11和下盘片12之间的间距时,既调节了上盘片11和下盘片12之间的夹持力,又调节了腰部14的直径,增加了腰部14固定在病变位置的稳定性。As shown in FIG. 2 , the upper disk 11 and the lower disk 12 are connected not only by the spring 131 but also by the waist 14 . The waist 14 is braided by shape-memory wire mesh and surrounds the spring 131 in the middle. This design makes when adjusting the distance between the upper disc 11 and the lower disc 12, both the clamping force between the upper disc 11 and the lower disc 12 has been adjusted, and the diameter of the waist 14 has been adjusted, increasing the The waist 14 is fixed for stability at the lesion position.

如图2至图6所示,弹簧131可为圆柱状标准弹簧、方形弹簧、椭圆弹簧或圆锥状弹簧等各种不同形状的弹簧,可以适应不同形态的病变,适应性更广。As shown in Figures 2 to 6, the spring 131 can be a cylindrical standard spring, a square spring, an elliptical spring or a conical spring and other springs of various shapes, which can adapt to different forms of lesions and have wider adaptability.

如图7a至图8b所示,弹性连接件13为管形网状编织结构133,管形网状编织结构133由形状记忆丝线网状编织而成。其中,管形网状编织结构133的活动端设有编织结构结扎套134,编织结构结扎套134能穿过下盘片12插入下盘片结扎套121中,编织结构结扎套134远离管形网状编织结构133的一端设有结扎套限位头部135,结扎套限位头部135的外径大于下盘片结扎套121的内径,管形网状编织结构133靠近编织结构结扎套134的一端设有沿径向伸展的伸展翼136,伸展翼136的外径大于下盘片结扎套121的内径。As shown in FIGS. 7 a to 8 b , the elastic connector 13 is a tubular mesh-like braided structure 133 , and the tubular mesh-like braided structure 133 is braided by shape memory wires. Wherein, the movable end of tubular network braided structure 133 is provided with braided structure ligation sheath 134, and braided structure ligation sheath 134 can be inserted in the lower disc ligation sheath 121 through lower disk 12, and braided structure ligation sheath 134 is far away from tubular net One end of the shape braided structure 133 is provided with a ligation sheath limiting head 135, the outer diameter of the ligation sheath limiting head 135 is larger than the inner diameter of the lower plate ligation sheath 121, and the tubular reticular weaving structure 133 is close to the braided structure ligation sheath 134 One end is provided with a stretching wing 136 extending radially, and the outer diameter of the stretching wing 136 is larger than the inner diameter of the lower disc ligation sleeve 121 .

如图7a和图8a所示的封堵装置,其伸展翼136位于上盘片11与下盘片12之间,当需要调节上盘片11、下盘片12之间的夹持力时,将编织结构结扎套134、伸展翼136一起经下盘片结扎套121拉出至外部,由于伸展翼136由形状记忆丝线网状编织而成,当伸展翼136拉出至下盘片结扎套121的外部后,伸展翼136释放展开为原先设定的形状,杜绝了编织结构结扎套134再次回到下盘片结扎套121中的可能性;此时封堵装置的形状变为如图7b、图8b所示,上盘片11、下盘片12之间的距离较之前有所变化,从而调节了上盘片11、下盘片12之间的夹持力。As shown in Figure 7a and Figure 8a, the extension wing 136 is located between the upper disk 11 and the lower disk 12, when the clamping force between the upper disk 11 and the lower disk 12 needs to be adjusted, The braided structure ligature 134 and the extension wings 136 are pulled out to the outside through the lower disk ligature 121. Since the extension wings 136 are woven from shape-memory wire mesh, when the extension wings 136 are pulled out to the lower disk ligature 121 After the outside, the stretching wings 136 are released and unfolded into the originally set shape, which prevents the possibility that the braided structure ligature 134 will return to the lower disc ligature 121 again; As shown in FIG. 8 b , the distance between the upper disc 11 and the lower disc 12 has changed compared with before, thereby adjusting the clamping force between the upper disc 11 and the lower disc 12 .

如图9a至图10所示,推送杆2包括推送杆外壳21、推送杆内芯22,推送杆内芯22在推送杆外壳21的内腔内沿轴线移动或旋转,推送杆外壳21的端部与下盘片结扎套121可拆卸连接,推送杆内芯22的端部与弹性连接件13的活动端可拆卸连接。其中,推送杆外壳21的端部与下盘片结扎套121螺纹连接。如图9a至图9f所示,推送杆内芯22的端部与弹性连接件13的活动端通过夹扣23连接;如图10所示,推送杆内芯22的端部与弹性连接件13的活动端螺纹连接。As shown in Figures 9a to 10, the push rod 2 includes a push rod shell 21 and a push rod inner core 22, the push rod inner core 22 moves or rotates along the axis in the inner cavity of the push rod shell 21, and the end of the push rod shell 21 The upper part is detachably connected with the lower disc ligation sleeve 121, and the end of the push rod inner core 22 is detachably connected with the movable end of the elastic connector 13. Wherein, the end of the push rod housing 21 is screwed to the lower disc ligation sleeve 121 . As shown in Figures 9a to 9f, the end of the push rod inner core 22 is connected to the movable end of the elastic connector 13 through a clip 23; as shown in Figure 10, the end of the push rod inner core 22 is connected to the elastic connector 13 The active end threaded connection.

使用上述可调式封堵装置的释放方法,主要包括以下步骤:The release method using the above-mentioned adjustable blocking device mainly includes the following steps:

1)将推送杆2与封堵器1连接,拉动推送杆2,将封堵器1拉入输送鞘管3内,其具体包括以下步骤,1) Connect the push rod 2 to the occluder 1, pull the push rod 2, and pull the occluder 1 into the delivery sheath 3, which specifically includes the following steps,

①将弹性连接件13的活动端与推送杆内芯22的端部连接,如图9a至图9c所示的弹性连接件13的活动端与推送杆内芯22的端部通过夹扣23连接,如图10所示的弹性连接件13的活动端与推送杆内芯22的端部通过螺纹连接;①Connect the movable end of the elastic connector 13 to the end of the inner core 22 of the push rod, as shown in Figure 9a to Figure 9c, the movable end of the elastic connector 13 is connected to the end of the inner core 22 of the push rod through a clip 23 , the movable end of the elastic connector 13 shown in Figure 10 is threadedly connected to the end of the push rod inner core 22;

②将推送杆内芯22连同弹性连接件13的活动端一起拉入推送杆外壳21中,如图9d所示;② Pull the inner core 22 of the push rod together with the movable end of the elastic connector 13 into the outer shell 21 of the push rod, as shown in Figure 9d;

③将推送杆外壳21与下盘片结扎套121固定连接,如图9d所示;③Fixly connect the push rod housing 21 with the lower disc ligation sleeve 121, as shown in Figure 9d;

④推送杆内芯22连同弹性连接件13的活动端,在推送杆外壳21的空腔内沿轴线移动或旋转,调节弹性连接件13在上盘片11和下盘片12之间的长度,如图9e所示;④ The push rod inner core 22 together with the movable end of the elastic connector 13 moves or rotates along the axis in the cavity of the push rod shell 21 to adjust the length of the elastic connector 13 between the upper disk 11 and the lower disk 12, As shown in Figure 9e;

⑤拉动推送杆2,将封堵器1拉入输送鞘管3内;⑤ Pull the push rod 2 to pull the occluder 1 into the delivery sheath 3;

2)通过输送鞘管3,将封堵器1送至病变位置;2) Send the occluder 1 to the lesion position by delivering the sheath tube 3;

3)推送推送杆外壳21,将上盘片11释放;3) Push the push lever housing 21 to release the upper disc 11;

4)同时推送推送杆外壳21与推送杆内芯22,释放弹性连接件13;4) Simultaneously push the push rod shell 21 and the push rod inner core 22 to release the elastic connector 13;

5)推送杆内芯22保持不动,推送推送杆外壳21,下盘片12部分释放;5) The inner core 22 of the push rod remains motionless, the outer shell 21 of the push rod is pushed, and the lower disc 12 is partially released;

6)将推送杆外壳21与下盘片结扎套121分离;6) separating the push rod housing 21 from the lower disc ligation sleeve 121;

7)观察封堵器1是否稳定牢固,若有需要,调节弹性连接件13在上盘片11和下盘片12之间的长度;其中,调节弹性连接件13在上盘片11和下盘片12之间的长度的过程包括以下步骤,7) Observe whether the occluder 1 is stable and firm. If necessary, adjust the length of the elastic connector 13 between the upper disc 11 and the lower disc 12; wherein, adjust the elastic connector 13 between the upper disc 11 and the lower disc. The process of length between pieces 12 includes the following steps,

①将推送杆外壳21前推,使推送杆内芯22与弹性连接件13回收到推送杆外壳21的内腔内;① Push the push rod shell 21 forward, so that the push rod inner core 22 and the elastic connector 13 are recovered into the inner cavity of the push rod shell 21;

②将推送杆外壳21与下盘片结扎套121固定连接;②Fixly connect the push rod housing 21 with the lower disc ligation sleeve 121;

③将推送杆内芯22及弹性连接件13的活动端一起在推送杆外壳21的空腔内沿轴线移动或旋转,调节弹性连接件13在上盘片11和下盘片12之间的长度;③ Move or rotate the push rod inner core 22 and the movable end of the elastic connector 13 along the axis in the cavity of the push rod shell 21, and adjust the length of the elastic connector 13 between the upper disc 11 and the lower disc 12 ;

④将推送杆外壳21与下盘片结扎套121分离。④ Separate the push rod housing 21 from the lower disc ligation sleeve 121 .

8)抽回推送杆外壳21,推送杆内芯22与弹性连接件13外露且完全释放;8) Withdrawing the push rod shell 21, the push rod inner core 22 and the elastic connector 13 are exposed and completely released;

9)将推送杆内芯22与弹性连接件13的活动端分离,此时,若弹性连接件13为如图9f所示的弹簧131时,则弹簧131留在下盘片结扎套121外部的部分自动卷曲,不会再往下盘片结扎套121内缩回,若弹性连接件13为如图10所示的管形网状编织结构133,则伸展翼136杜绝了管形网状编织结构133缩回的可能性。9) Separate the push rod inner core 22 from the movable end of the elastic connector 13. At this time, if the elastic connector 13 is a spring 131 as shown in FIG. Automatic curling, and will not be retracted into the lower disc ligation sleeve 121. If the elastic connector 13 is a tubular mesh weaving structure 133 as shown in FIG. Possibility of retraction.

上述方法中,若封堵器1如图2所示,则在释放或收回弹性连接件13的同时,也一起释放或收回腰部14。In the above method, if the occluder 1 is shown in FIG. 2 , when the elastic connecting member 13 is released or retracted, the waist 14 is also released or retracted.

综上所述,本发明可调式封堵装置及释放方法,通过调节弹性连接件在上盘片和下盘片之间的长度,达到调节上盘片和下盘片之间的夹持力的目的,使封堵装置更稳定牢固,与病变位置贴合更良好,可以适应不同大小、不同长度的病变,同时该可调式封堵装置的可回收再释放性使得手术发生意外时可以纠正,降低了手术风险和手术操作难度。所以,本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。In summary, the adjustable blocking device and release method of the present invention can adjust the clamping force between the upper disk and the lower disk by adjusting the length of the elastic connecting piece between the upper disk and the lower disk. Purpose: To make the occlusion device more stable and firm, fit better with the lesion, and can adapt to lesions of different sizes and lengths. At the same time, the adjustable occlusion device can be recovered and released so that it can be corrected when an accident occurs during surgery, reducing the risk of injury. Surgical risk and difficulty of operation. Therefore, the present invention effectively overcomes various shortcomings in the prior art and has high industrial application value.

上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。The above-mentioned embodiments only illustrate the principles and effects of the present invention, but are not intended to limit the present invention. Anyone skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and technical ideas disclosed in the present invention should still be covered by the claims of the present invention.

Claims (12)

1. an adjustable plugging device, it is characterized in that: described plugging device comprises stopper (1) and push rod (2), described stopper (1) comprises disc (11) and lower disc (12), described upper disc (11), lower disc (12) is woven by shape memory wire mesh shape and forms, Flexible Connector (13) is provided with between described upper disc (11) and lower disc (12), described Flexible Connector (13) is provided with the stiff end fixing with described upper disc (11) and the movable end through described lower disc (12), the below of described lower disc (12) is provided with lower disc ligation cover (121), the movable end of described Flexible Connector (13) removably connects through described lower disc ligation cover (121) and push rod (2), described push rod (2) pulls described Flexible Connector (13) vertically, regulates the length of described Flexible Connector (13) on described between disc (11) and lower disc (12), when described push rod (2) and Flexible Connector (13) depart from, the movable end of described Flexible Connector (13) and the relative position of described lower disc ligation cover (121) remain unchanged.
2. adjustable plugging device according to claim 1, it is characterized in that: described push rod (2) comprises push rod shell (21), push rod inner core (22), described push rod inner core (22) to be moved along axis at the interior intracavity of described push rod shell (21) or is rotated, end and the lower disc ligation cover (121) of described push rod shell (21) removably connect, and the end of described push rod inner core (22) and the movable end of Flexible Connector (13) removably connect.
3. adjustable plugging device according to claim 2, is characterized in that: the end of described push rod shell (21) is threaded with lower disc ligation cover (121).
4. adjustable plugging device according to claim 2, is characterized in that: the end of described push rod inner core (22) is threaded with the movable end of Flexible Connector (13) or is connected by clip (23).
5. adjustable plugging device according to claim 1, is characterized in that: described Flexible Connector (13) is spring (131).
6. adjustable plugging device according to claim 5, it is characterized in that: the movable end of described spring (131) is provided with spring retainer head (132), the external diameter of described spring retainer head (132) is greater than the internal diameter of described lower disc ligation cover (121).
7. adjustable plugging device according to claim 5, is characterized in that: described spring (131) is cylindric standard spring, square spring, double laminated spring or coniform spring.
8. adjustable plugging device according to claim 1, it is characterized in that: described Flexible Connector (13) is pipe type netted braiding structure (133), described pipe type netted braiding structure (133) is woven by shape memory wire mesh shape and forms.
9. adjustable plugging device according to claim 8, it is characterized in that: the movable end of described pipe type netted braiding structure (133) is provided with braiding structure ligation cover (134), described braiding structure ligation cover (134) can be inserted in lower disc ligation cover (121) through described lower disc (12), described braiding structure ligation cover (134) is provided with ligation away from one end of described pipe type netted braiding structure (133) and overlaps spacing head (135), the external diameter that spacing head (135) is overlapped in described ligation is greater than the internal diameter of described lower disc ligation cover (121), described pipe type netted braiding structure (133) is provided with near one end of described braiding structure ligation cover (134) the stretching, extension wing (136) radially stretched, the external diameter of the described stretching, extension wing (136) is greater than the internal diameter of described lower disc ligation cover (121).
10. use a method for releasing for the adjustable plugging device described in claim 2, it is characterized in that comprising the following steps:
1) described push rod (2) is connected with stopper (1), pulls described push rod (2), described stopper (1) is drawn in delivery sheath (3);
2) by described delivery sheath (3), described stopper (1) is delivered to lesion locations;
3) described push rod shell (21) is pushed, by described upper disc (11) release;
4) push described push rod shell (21) and push rod inner core (22), release Flexible Connector (13) simultaneously;
5) described push rod inner core (22) keeps motionless, pushes described push rod shell (21), the release of described lower disc (12) part;
6) described push rod shell (21) is separated with lower disc ligation cover (121);
7) observe described stopper (1) whether firmly stable, if necessary, regulate the length of described Flexible Connector (13) on described between disc (11) and lower disc (12);
8) draw back described push rod shell (21), described push rod inner core (22) and Flexible Connector (13) expose and discharge completely;
9) described push rod inner core (22) is separated with the movable end of Flexible Connector (13).
The method for releasing of 11. adjustable plugging devices according to claim 10, is characterized in that, described step 1) comprise the following steps:
1. the end of the movable end of described Flexible Connector (13) with push rod inner core (22) is connected;
2. described push rod inner core (22) is drawn in described push rod shell (21) together with the movable end of Flexible Connector (13);
3. described push rod shell (21) is fixedly connected with lower disc ligation cover (121);
4. described push rod inner core (22) is together with the movable end of Flexible Connector (13), move along axis in the cavity of described push rod shell (21) or rotate, regulating the length of described Flexible Connector (13) on described between disc (11) and lower disc (12);
5. pull described push rod (2), described stopper (1) is drawn in delivery sheath (3).
The method for releasing of 12. adjustable plugging devices according to claim 10, it is characterized in that, step 7) in regulate the process of the length of described Flexible Connector (13) on described between disc (11) and lower disc (12) to comprise the following steps: 1. push away front for described push rod shell (21), make described push rod inner core (22) and Flexible Connector (13) be recovered to the interior intracavity of described push rod shell (21);
2. described push rod shell (21) is fixedly connected with lower disc ligation cover (121);
3. the movable end of described push rod inner core (22) and Flexible Connector (13) moved along axis together or rotates in the cavity of described push rod shell (21), regulating the length of described Flexible Connector (13) on described between disc (11) and lower disc (12);
4. described push rod shell (21) is separated with lower disc ligation cover (121).
CN201510026530.8A 2015-01-19 2015-01-19 Adjustable plugging device and release method Expired - Fee Related CN104546054B (en)

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WO2017113629A1 (en) * 2015-12-28 2017-07-06 先健科技(深圳)有限公司 Occuluder
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CN107233117B (en) * 2016-03-28 2019-10-25 上海微创医疗器械(集团)有限公司 Occluder for left auricle
CN107233117A (en) * 2016-03-28 2017-10-10 上海微创医疗器械(集团)有限公司 Occluder for left auricle
CN107233115A (en) * 2016-03-28 2017-10-10 上海微创医疗器械(集团)有限公司 Occluder for left auricle
CN107233115B (en) * 2016-03-28 2020-01-24 上海微创医疗器械(集团)有限公司 Left auricle plugging device
CN109715086A (en) * 2016-08-16 2019-05-03 斯巴达微型公司 Intravascular stream transfer
CN106473791B (en) * 2016-09-22 2023-10-27 杭州德诺电生理医疗科技有限公司 Left auricle plugging device with adjustable distance
CN106473791A (en) * 2016-09-22 2017-03-08 杭州诺茂医疗科技有限公司 A kind of occluder for left auricle of adjustable distance
CN107019529A (en) * 2017-05-26 2017-08-08 潘湘斌 A kind of atrial septal defect plugging device and its interventional method
CN111358512A (en) * 2018-12-26 2020-07-03 福建医科大学附属协和医院 An atrial septal defect closure device with adjustment function
CN109700496A (en) * 2019-03-06 2019-05-03 中南大学湘雅医院 A kind of heart occluder
CN110974316A (en) * 2019-11-19 2020-04-10 先健科技(深圳)有限公司 Plugging device
CN110974316B (en) * 2019-11-19 2021-06-04 先健科技(深圳)有限公司 Plugging device
CN111000601A (en) * 2019-12-17 2020-04-14 先健科技(深圳)有限公司 Occluder and occlusion system
CN111000601B (en) * 2019-12-17 2021-11-16 先健科技(深圳)有限公司 Occluder and occlusion system
CN114767180A (en) * 2022-04-11 2022-07-22 四川大学华西医院 Atrial septal defect plugging device
CN115252010A (en) * 2022-06-28 2022-11-01 上海形状记忆合金材料有限公司 Plugging device
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WO2024208010A1 (en) * 2023-04-04 2024-10-10 杭州唯强医疗科技有限公司 Occluding device and occluding system

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