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CN104720854B - Sectioned degradable plugging device - Google Patents

Sectioned degradable plugging device Download PDF

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Publication number
CN104720854B
CN104720854B CN201510087462.6A CN201510087462A CN104720854B CN 104720854 B CN104720854 B CN 104720854B CN 201510087462 A CN201510087462 A CN 201510087462A CN 104720854 B CN104720854 B CN 104720854B
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China
Prior art keywords
diaphragm
inner core
connecting rod
degradable
split
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Expired - Fee Related
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CN201510087462.6A
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CN104720854A (en
Inventor
李博
罗鹏
杨永森
陈娟
蒲忠杰
王超
李超
张芳芳
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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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Priority to CN201510087462.6A priority Critical patent/CN104720854B/en
Publication of CN104720854A publication Critical patent/CN104720854A/en
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Publication of CN104720854B publication Critical patent/CN104720854B/en
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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
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12031Type of occlusion complete occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • 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

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Reproductive Health (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Prostheses (AREA)
  • Absorbent Articles And Supports Therefor (AREA)

Abstract

本发明提供一种分瓣式可降解封堵器,它包括网状支架,网状支架由可降解丝线编织而成,网状支架包括上盘面、下盘面和连接上盘面、下盘面的腰部,上盘面缝有覆盖在上盘面上的上隔膜,下盘面缝有覆盖在下盘面上的下隔膜,腰部设有将腰部横向拦截的阻流膜,上隔膜、下隔膜和阻流膜由可降解材料制成,下盘面的中间设有内芯连接杆,内芯连接杆与下隔膜连接在一起,上盘面的中间设有卡位结构,内芯连接杆能穿过阻流膜卡在卡位结构上。该分瓣式可降解封堵器,针对的是高分子类可降解封堵装置,它通过结构方面的创新来补偿高分子材料的力学性能差所带来的一系列诸如回弹性、固定稳定性等问题。

The invention provides a split-type degradable occluder, which includes a mesh support, the mesh support is woven from degradable silk threads, and the mesh support includes an upper plate, a lower plate and a waist connecting the upper plate and the lower plate. The upper plate is sewn with an upper diaphragm covering the upper plate, the lower plate is sewn with a lower diaphragm covering the lower plate, and the waist is provided with a blocking film that intercepts the waist laterally. The upper diaphragm, the lower diaphragm and the blocking film are made of degradable materials. Made, the inner core connecting rod is set in the middle of the lower plate, the inner core connecting rod is connected with the lower diaphragm, and the middle of the upper plate is provided with a clamping structure, the inner core connecting rod can pass through the flow blocking film and be stuck in the clamping structure superior. The split-flap degradable occluder is aimed at polymer degradable occlusion devices. It uses structural innovations to compensate for a series of problems such as resilience and fixation stability caused by poor mechanical properties of polymer materials. And other issues.

Description

分瓣式可降解封堵器Split-valve degradable occluder

技术领域technical field

本发明涉及一种分瓣式可降解封堵器。The invention relates to a split-valve degradable occluder.

背景技术Background technique

针对先天性心脏病,临床上常用的封堵器是蘑菇伞形封堵器,主要工作原理是以金属为支架将阻流膜材稳定在病变位置,等待血栓吸附,最终封堵器内皮化,与周边组织完全融合。但金属类封堵器植入后会造成以下几个问题:1)终身滞留于人体内,影响后续可能的外科手术治疗;2)在核磁共振及CT检查时出现伪影;3)可能改变心脏的几何构型引发血栓、急性心肌梗死等不良反应;4)NiTi网状支架在组织内会缓慢释放Ni离子。For congenital heart disease, the commonly used clinical occluder is the mushroom umbrella occluder. The main working principle is to stabilize the flow-blocking membrane at the lesion position with metal as the bracket, wait for the thrombus to be adsorbed, and finally endothelialize the occluder. Fully integrated with surrounding tissues. However, the implantation of the metal occluder will cause the following problems: 1) It will remain in the human body for life, which will affect the possible follow-up surgical treatment; 2) Artifacts will appear in MRI and CT examinations; 3) It may change the heart The geometric configuration can cause adverse reactions such as thrombosis and acute myocardial infarction; 4) NiTi mesh scaffolds will slowly release Ni ions in the tissue.

因此,如能研制一种在起到固定作用后会完全降解掉的封堵装置,可以克服金属封堵器以上的弱点,必将为先心病的治疗开辟新的天地。但高分子易降解材料较脆,且力学性能没有金属好,所以高分子材料制得的封堵装置在固定性能方面又是一个瓶颈。Therefore, if can develop a kind of occluding device that can degrade completely after playing fixation effect, can overcome the weakness above the metal occluder, will open up a new world for the treatment of congenital heart disease. However, the easily degradable polymer material is brittle, and its mechanical properties are not as good as metal, so the plugging device made of polymer material is another bottleneck in terms of fixing performance.

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分瓣式可降解封堵器,用于解决现有技术中易降解材料制成的封堵器固定性能不佳的问题。In view of the above-mentioned shortcomings of the prior art, the object of the present invention is to provide a split-type degradable occluder to solve the problem of poor fixation performance of the occluder made of easily degradable materials in the prior art.

为实现上述目的及其他相关目的,本发明提供一种分瓣式可降解封堵器,它包括网状支架,网状支架由可降解丝线编织而成,网状支架包括上盘面、下盘面和连接上盘面、下盘面的腰部,上盘面缝有覆盖在上盘面上的上隔膜,下盘面缝有覆盖在下盘面上的下隔膜,腰部设有将腰部横向拦截的阻流膜,上隔膜、下隔膜和阻流膜由可降解材料制成,下盘面的中间设有内芯连接杆,内芯连接杆与下隔膜连接在一起,上盘面的中间设有卡位结构,内芯连接杆能穿过阻流膜卡在卡位结构上。In order to achieve the above purpose and other related purposes, the present invention provides a split degradable occluder, which includes a mesh support, the mesh support is woven from degradable silk threads, and the mesh support includes an upper plate, a lower plate and The waist connecting the upper plate and the lower plate, the upper plate is sewn with an upper diaphragm covering the upper plate, the lower plate is sewn with a lower diaphragm covering the lower plate, and the waist is provided with a flow-blocking film that intercepts the waist laterally, the upper diaphragm, the lower The diaphragm and flow blocking film are made of degradable materials. There is an inner core connecting rod in the middle of the lower plate. The inner core connecting rod is connected with the lower diaphragm. There is a clamping structure in the middle of the upper plate. The over-restriction film is stuck on the clamping structure.

优选的,网状支架所用的可降解丝线的材料为聚乳酸、聚己内酯、聚乙醇酸、聚对二氧环己酮或聚羟基丁酸。Preferably, the material of the degradable thread used in the mesh stent is polylactic acid, polycaprolactone, polyglycolic acid, polydioxanone or polyhydroxybutyric acid.

优选的,上隔膜、下隔膜和阻流膜的材料为聚乳酸、聚乳酸-羟基乙酸共聚物或聚己内酯。Preferably, the material of the upper diaphragm, the lower diaphragm and the blocking film is polylactic acid, polylactic acid-glycolic acid copolymer or polycaprolactone.

优选的,上隔膜、下隔膜或阻流膜通过可降解缝线与网状支架缝在一起。Preferably, the upper diaphragm, the lower diaphragm or the blocking membrane are sewn together with the mesh support through degradable sutures.

进一步的优选,缝线的材料为二氧环已酮。Further preferably, the material of the suture is dioxane.

进一步的优选,缝线内混有显影物质。Further preferably, a developing substance is mixed in the suture.

优选的,内芯连接杆内混有显影物质。Preferably, a developing substance is mixed in the connecting rod of the inner core.

优选的,上盘面的直径比腰部的直径大6~16mm,下盘面的直径比腰部的直径大4~12mm。Preferably, the diameter of the upper disc is 6-16mm larger than the diameter of the waist, and the diameter of the lower disc is 4-12mm larger than the diameter of the waist.

优选的,内芯连接杆位于下盘面外部的端部设有沿径向贯穿的第一保险线穿孔,内芯连接杆位于下盘面外部的端面设有沿轴向向内延伸的推杆连接孔。Preferably, the end of the inner core connecting rod located outside the lower panel is provided with a radially penetrated first safety line perforation, and the end surface of the inner core connecting rod located outside the lower panel is provided with a push rod connecting hole extending axially inward .

优选的,阻流膜的中间设有多片能翻起的瓣叶状的阻流膜片,多片阻流膜片沿阻流膜的中心的周向分布,多片阻流膜片的能翻起的一端部分重叠在一起。Preferably, the middle of the choke film is provided with a plurality of leaflet-shaped choke diaphragms that can be turned up, and the multi-piece choke diaphragms are distributed along the circumferential direction of the center of the choke film, and the energy of the multi-piece choke diaphragms The turned-up ends partially overlap each other.

进一步的优选,内芯连接杆面向上盘面的端部设有卡位突起,卡位突起的直径大于内芯连接杆的直径;内芯连接杆穿过多片阻流膜片围成的中心后,卡位突起卡在上盘面的卡位结构上。Further preferably, the end of the inner core connecting rod facing the upper disk surface is provided with a locking protrusion, and the diameter of the locking protrusion is larger than the diameter of the inner core connecting rod; after the inner core connecting rod passes through the center surrounded by a plurality of choke diaphragms, , the clamping protrusion is clamped on the clamping structure on the upper disk surface.

更进一步的优选,阻流膜片能向上盘面的方向翻起,卡位结构由位于上隔膜的中心的多片能翻起的瓣叶状的卡位膜片组成,多片卡位膜片沿上盘面的中心的周向分布,多片卡位膜片的能翻起的一端部分重叠在一起;内芯连接杆穿过多片阻流膜片围成的中心后,再穿过多片卡位膜片围成的中心,多片卡位膜片将卡位突起卡住。Further preferably, the blocking diaphragm can be turned up toward the disk surface, and the locking structure is composed of a plurality of leaflet-shaped locking diaphragms that can be turned up in the center of the upper diaphragm, and the plurality of locking diaphragms are along the In the circumferential distribution of the center of the upper plate, the turned-up ends of the multiple clamping diaphragms are partially overlapped; after the inner core connecting rod passes through the center surrounded by multiple blocking diaphragms, it passes through the In the center surrounded by the bit diaphragm, multiple snap bit diaphragms clamp the snap bit protrusion.

更进一步的优选,阻流膜片能向上盘面的方向翻起,卡位结构为位于上盘面的上端面上的圆孔;内芯连接杆穿过多片阻流膜片围成的中心后,再穿过圆孔,圆孔将卡位突起卡住。More preferably, the choke diaphragm can be turned up toward the upper disk surface, and the locking structure is a round hole located on the upper end surface of the upper disk surface; after the inner core connecting rod passes through the center surrounded by a plurality of choke diaphragms, Then pass through the round hole, and the round hole will block the locking protrusion.

更进一步的优选,阻流膜片能向下盘面的方向翻起,卡位结构包括位于上盘面的中心的卡位柱,卡位柱与上隔膜连接,卡位柱面向下盘面的端面设有一个沿轴向向内延伸的插入口,插入口的端口设有沿径向向内延伸的第一凸缘,卡位柱面向下盘面的端部还设有沿径向向外延伸的第二凸缘;内芯连接杆穿过多片阻流膜片围成的中心后,再插入插入口中,第一凸缘将卡位突起卡住,内芯连接杆拉住卡位柱穿过阻流膜后,阻流膜片将第二凸缘卡住。Further preferably, the flow blocking diaphragm can be turned up towards the direction of the lower disk, and the locking structure includes a locking column located in the center of the upper panel, the locking column is connected with the upper diaphragm, and the locking column faces the end surface of the lower panel. An insertion port extending inward in the axial direction, the port of the insertion port is provided with a first flange extending radially inward, and the end of the clamping cylinder facing the lower disk surface is also provided with a second flange extending radially outward Flange; the connecting rod of the inner core passes through the center surrounded by multiple choke diaphragms, and then is inserted into the insertion port, the first flange clamps the locking protrusion, and the connecting rod of the inner core pulls the locking column to pass through the choking After the diaphragm, the choke diaphragm clamps the second flange.

更进一步的优选,阻流膜片能向上盘面的方向翻起,卡位结构包括位于上盘面的中心的卡位柱,卡位柱与上隔膜连接,卡位柱面向下盘面的端面设有一个沿轴向向内延伸的插入口,插入口的周面设有沿周向延伸的凹口;内芯连接杆穿过多片阻流膜片围成的中心后,再插入插入口中,内芯连接杆旋转后,卡位突起卡入凹口中。Further preferably, the flow blocking diaphragm can be turned up toward the upper disk surface, and the locking structure includes a locking column located at the center of the upper panel surface, the locking column is connected to the upper diaphragm, and a locking column is provided on the end surface of the lower panel surface. The insertion port extending inward in the axial direction, the peripheral surface of the insertion port is provided with a notch extending in the circumferential direction; the connecting rod of the inner core passes through the center surrounded by a plurality of blocking diaphragms, and then is inserted into the insertion port, the inner core After the connecting rod is rotated, the locking protrusion is locked into the notch.

如上所述,本发明分瓣式可降解封堵器,具有以下有益效果:As mentioned above, the split-valve degradable occluder of the present invention has the following beneficial effects:

该分瓣式可降解封堵器,针对的是高分子类可降解封堵装置,它通过结构方面的创新来补偿高分子材料的力学性能差所带来的一系列诸如回弹性、固定稳定性等问题。The split-flap degradable occluder is aimed at polymer degradable occlusion devices. It uses structural innovations to compensate for a series of problems such as resilience and fixation stability caused by poor mechanical properties of polymer materials. And other issues.

附图说明Description of drawings

图1a显示为本发明分瓣式可降解封堵器的第一种实施方式的结构示意图。Fig. 1a is a schematic structural view of the first embodiment of the split-valve degradable occluder of the present invention.

图1b显示为图1a所示的分瓣式可降解封堵器的卡位结构的俯视图。Fig. 1b is a top view of the locking structure of the split-valve degradable occluder shown in Fig. 1a.

图1c显示为图1a所示的分瓣式可降解封堵器的阻流膜的俯视图。Fig. 1c is a top view of the flow blocking membrane of the split-valve degradable occluder shown in Fig. 1a.

图2a显示为本发明分瓣式可降解封堵器的第二种实施方式的结构示意图。Fig. 2a is a schematic structural view of the second embodiment of the split-valve degradable occluder of the present invention.

图2b显示为图2a所示的分瓣式可降解封堵器的俯视图。Fig. 2b is a top view of the split-valve degradable occluder shown in Fig. 2a.

图2c显示为图2a所示的分瓣式可降解封堵器的阻流膜的俯视图。Fig. 2c is a top view of the flow blocking membrane of the split-valve degradable occluder shown in Fig. 2a.

图3a显示为本发明分瓣式可降解封堵器的第三种实施方式的结构示意图。Fig. 3a is a schematic structural view of the third embodiment of the split-valve degradable occluder of the present invention.

图3b显示为图3a所示的分瓣式可降解封堵器的俯视图。Fig. 3b is a top view of the split-valve degradable occluder shown in Fig. 3a.

图4a显示为本发明分瓣式可降解封堵器的第四种实施方式的结构示意图。Fig. 4a is a schematic structural diagram of the fourth embodiment of the split-valve degradable occluder of the present invention.

图4b显示为图4a所示的分瓣式可降解封堵器的卡位柱的A-A向部分剖视图。Fig. 4b is a partial sectional view along the line A-A of the clamping post of the split-valve degradable occluder shown in Fig. 4a.

图4c显示为图4a所示的分瓣式可降解封堵器的阻流膜的俯视图。Fig. 4c is a top view of the flow blocking membrane of the split-valve degradable occluder shown in Fig. 4a.

图5显示为本发明分瓣式可降解封堵器位于输送鞘管内的示意图。Fig. 5 is a schematic diagram of the split-valve degradable occluder of the present invention located in the delivery sheath.

图6显示为本发明分瓣式可降解封堵器与推送杆连接的示意图。Fig. 6 is a schematic diagram showing the connection between the split-valve degradable occluder and the pushing rod of the present invention.

元件标号说明Component designation description

1 网状支架1 mesh stand

11 上盘面11 Upper surface

12 下盘面12 lower panel

13 腰部13 waist

2 上隔膜2 upper diaphragm

3 下隔膜3 lower diaphragm

4 阻流膜4 Barrier film

41 阻流膜片41 Choke diaphragm

5 内芯连接杆5 Inner core connecting rod

51 卡位突起51 card position protrusion

52 第一保险线穿孔52 The first insurance line perforation

53 推杆连接孔53 Push rod connecting hole

54 中部槽54 middle slot

6 卡位结构6 slot structure

61 卡位柱61 snap post

62 插入口62 Insertion port

63 第一凸缘63 First flange

64 第二凸缘64 Second flange

65 凹口65 notches

66 卡位膜片66 position diaphragm

67 圆孔67 round hole

7 缝线7 stitches

8 输送鞘管8 Delivery sheath

9 推送杆9 push lever

91 推送杆头部91 push rod head

92 第二保险线穿孔92 Second safety wire perforation

10 导丝10 guide wire

101 保险线101 insurance line

具体实施方式detailed description

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6。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 6. 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6所示,本发明提供一种分瓣式可降解封堵器,它包括网状支架1,网状支架1由可降解丝线编织而成,网状支架1包括上盘面11、下盘面12和连接上盘面11、下盘面12的腰部13,上盘面11缝有覆盖在上盘面11上的上隔膜2,下盘面12缝有覆盖在下盘面12上的下隔膜3,腰部13设有将腰部13横向拦截的阻流膜4,上隔膜2、下隔膜3和阻流膜4由可降解材料制成,下盘面12的中间设有内芯连接杆5,内芯连接杆5与下隔膜3连接在一起,上盘面11的中间设有卡位结构6,内芯连接杆5能穿过阻流膜4卡在卡位结构6上。As shown in Figures 1 to 6, the present invention provides a split-valve degradable occluder, which includes a mesh stent 1 woven from degradable silk threads, and the mesh stent 1 includes an upper plate 11 , the lower panel 12 and the waist 13 connecting the upper panel 11 and the lower panel 12, the upper panel 11 is sewn with the upper diaphragm 2 covering the upper panel 11, the lower panel 12 is sewn with the lower diaphragm 3 covering the lower panel 12, and the waist 13 There is a flow blocking film 4 that intercepts the waist 13 laterally. The upper diaphragm 2, the lower diaphragm 3 and the flow blocking film 4 are made of degradable materials. It is connected with the lower diaphragm 3 , and there is a locking structure 6 in the middle of the upper plate surface 11 , and the inner core connecting rod 5 can pass through the flow blocking film 4 and be locked on the locking structure 6 .

上隔膜2与上盘面11缝制在一起,下隔膜3与下盘面12缝制在一起,内芯连接杆5与下隔膜3连接在一起,血流挤压上隔膜2时上隔膜2带动上盘面11内陷,内芯连接杆5穿过阻流膜4卡在卡位结构6上,使封堵器稳定地固定在缺损部位。该分瓣式可降解封堵器通过结构的创新,补偿了可降解高分子材料的力学性能差所带来的一系列诸如回弹性差、固定稳定性差等问题。The upper diaphragm 2 is sewn together with the upper plate surface 11, the lower diaphragm 3 is sewn together with the lower plate surface 12, the inner core connecting rod 5 is connected with the lower diaphragm 3, and the upper diaphragm 2 drives the upper diaphragm 2 when the blood flow squeezes the upper diaphragm 2. The disk surface 11 is sunken, and the inner core connecting rod 5 passes through the flow blocking membrane 4 and is stuck on the locking structure 6, so that the occluder is stably fixed on the defect site. The split-flap degradable occluder compensates for a series of problems such as poor resilience and poor fixation stability caused by poor mechanical properties of degradable polymer materials through structural innovation.

上述网状支架1所用的可降解丝线的材料为聚乳酸(PLA)、聚己内酯(PCL)、聚乙醇酸(PGA)、聚对二氧环己酮(PDO)或聚羟基丁酸(PHB)等;上隔膜2、下隔膜3和阻流膜4的材料为聚乳酸(PLLA)、聚乳酸-羟基乙酸共聚物(PLGA)或聚己内酯(PCL)。The material of the degradable thread used in the above-mentioned mesh stent 1 is polylactic acid (PLA), polycaprolactone (PCL), polyglycolic acid (PGA), polydioxanone (PDO) or polyhydroxybutyric acid ( PHB), etc.; the material of the upper diaphragm 2, the lower diaphragm 3 and the flow blocking film 4 is polylactic acid (PLLA), polylactic acid-glycolic acid copolymer (PLGA) or polycaprolactone (PCL).

其中,上隔膜2、下隔膜3或阻流膜4通过可降解缝线7与网状支架1缝在一起,缝线7的材料为二氧环已酮(PDO)。Wherein, the upper diaphragm 2, the lower diaphragm 3 or the flow blocking membrane 4 are sewn together with the mesh support 1 through a degradable suture 7, and the material of the suture 7 is dioxane (PDO).

缝线7、内芯连接杆5内还混有显影物质,显影物质可帮助封堵器实现显影功能,具有观察方便的优点,更快捷地判断封堵器的释放形态和准确位置。The suture 7 and the inner core connecting rod 5 are also mixed with a developing substance, which can help the occluder realize the developing function, has the advantage of convenient observation, and can judge the release form and exact position of the occluder more quickly.

上述结构中,上盘面11、下盘面12及腰部13的尺寸最优为:上盘面11的直径比腰部13的直径大6~16mm,下盘面12的直径比腰部13的直径大4~12mm。In the above structure, the optimal size of the upper disk surface 11, the lower disk surface 12 and the waist portion 13 is: the diameter of the upper disk surface 11 is 6-16 mm larger than the diameter of the waist portion 13, and the diameter of the lower disk surface 12 is 4-12 mm larger than the diameter of the waist portion 13.

如图1c、图2c、图3b、图4c所示,阻流膜4的中间设有多片能翻起的瓣叶状的阻流膜片41,多片阻流膜片41沿阻流膜4的中心的周向分布,多片阻流膜片41的能翻起的一端部分重叠在一起。多片阻流膜片41的重叠区域,可根据实际需求选择,如图1c、图2c、图3b、图4c所示。As shown in Fig. 1c, Fig. 2c, Fig. 3b, and Fig. 4c, a plurality of leaflet-shaped choke diaphragms 41 that can be turned up are arranged in the middle of the choke film 4, and the choke diaphragm 41 is arranged along the choke membrane. The circumferential distribution of the center of 4, one end part that can turn up of a plurality of choke diaphragms 41 overlaps together. The overlapping area of the plurality of choke diaphragms 41 can be selected according to actual needs, as shown in Fig. 1c, Fig. 2c, Fig. 3b, and Fig. 4c.

如图1a、图2a、图3a、图4a所示,内芯连接杆5面向上盘面11的端部设有卡位突起51,卡位突起51的直径大于内芯连接杆5的直径;内芯连接杆5穿过多片阻流膜片41围成的中心后,卡位突起51卡在上盘面11的卡位结构6上。As shown in Figure 1a, Figure 2a, Figure 3a, and Figure 4a, the end of the inner core connecting rod 5 facing the upper disk surface 11 is provided with a locking protrusion 51, and the diameter of the locking protrusion 51 is greater than the diameter of the inner core connecting rod 5; After the core connecting rod 5 passes through the center surrounded by a plurality of choke diaphragms 41 , the locking protrusion 51 is locked on the locking structure 6 of the upper disk surface 11 .

如图1a至图1c所示为该分瓣式可降解封堵器的第一种实施方式。阻流膜片41能向上盘面11的方向翻起,卡位结构6由位于上隔膜2的中心的多片能翻起的瓣叶状的卡位膜片66组成,多片卡位膜片66沿上盘面11的中心的周向分布,多片卡位膜片66的能翻起的一端部分重叠在一起;内芯连接杆5穿过多片阻流膜片41围成的中心后,再穿过多片卡位膜片66围成的中心,多片卡位膜片66将卡位突起51卡住,防止了内芯连接杆5的后退,使内芯连接杆5卡在卡位结构6上,封堵器能稳定地固定在缺损部位。The first embodiment of the split-valve degradable occluder is shown in Fig. 1a to Fig. 1c. The blocking diaphragm 41 can be turned up toward the direction of the upper disk surface 11, and the locking structure 6 is composed of a plurality of flap-shaped locking diaphragms 66 that can be turned up in the center of the upper diaphragm 2, and the plurality of locking diaphragms 66 Distributed along the circumferential direction of the center of the upper disk surface 11, the turned-up ends of the plurality of clamping diaphragms 66 overlap; after the inner core connecting rod 5 passes through the center surrounded by the plurality of blocking diaphragms 41, Passing through the center surrounded by a plurality of locking diaphragms 66, the plurality of locking diaphragms 66 block the locking protrusion 51, preventing the inner core connecting rod 5 from retreating, so that the inner core connecting rod 5 is stuck in the locking structure 6, the occluder can be stably fixed at the defect site.

如图2a至图2c所示为该分瓣式可降解封堵器的第二种实施方式。阻流膜片41能向上盘面11的方向翻起,卡位结构6为位于上盘面11的上端面上的圆孔67;内芯连接杆5穿过多片阻流膜片41围成的中心后,再穿过圆孔67,圆孔67将卡位突起51卡住,防止了内芯连接杆5的后退,使内芯连接杆5卡在卡位结构6上,封堵器能稳定地固定在缺损部位。上述内芯连接杆5面向上盘面11的端面还设有中部槽54,中部槽54的设计可以使内芯连接杆5卡入圆孔67中时,卡位突起51沿径向有活动的空间,使内芯连接杆5能更顺利地卡入圆孔67中。The second embodiment of the split-valve degradable occluder is shown in Fig. 2a to Fig. 2c. The choke diaphragm 41 can be turned up toward the upper disk surface 11, and the locking structure 6 is a round hole 67 located on the upper end surface of the upper disk surface 11; the inner core connecting rod 5 passes through the center surrounded by a plurality of choke diaphragms 41 Finally, through the round hole 67, the round hole 67 blocks the locking protrusion 51, preventing the inner core connecting rod 5 from retreating, so that the inner core connecting rod 5 is stuck on the locking structure 6, and the occluder can stably fixed at the defect site. The end surface of the above-mentioned inner core connecting rod 5 facing the upper disk surface 11 is also provided with a middle groove 54. The design of the middle groove 54 can make the inner core connecting rod 5 snap into the round hole 67, and the locking protrusion 51 has a movable space in the radial direction. , so that the inner core connecting rod 5 can be snapped into the circular hole 67 more smoothly.

如图3a至图3b所示为该分瓣式可降解封堵器的第三种实施方式。阻流膜片41能向下盘面12的方向翻起,卡位结构6包括位于上盘面11的中心的卡位柱61,卡位柱61与上隔膜2连接,卡位柱61面向下盘面12的端面设有一个沿轴向向内延伸的插入口62,插入口62的端口设有沿径向向内延伸的第一凸缘63,卡位柱61面向下盘面12的端部还设有沿径向向外延伸的第二凸缘64;内芯连接杆5穿过多片阻流膜片41围成的中心后,再插入插入口62中,第一凸缘63将卡位突起51卡住,使内芯连接杆5与卡位柱61卡住;内芯连接杆5拉住卡位柱61穿过阻流膜4后,阻流膜片41将第二凸缘64卡住,防止内芯连接杆5向上盘面11的方向后退,使封堵器能稳定地固定在缺损部位。上述内芯连接杆5面向上盘面11的端面还设有中部槽54,中部槽54的设计可以使内芯连接杆5卡入插入口62中时,卡位突起51沿径向有活动的空间,使内芯连接杆5能更顺利地卡入插入口62中。The third embodiment of the split-valve degradable occluder is shown in Fig. 3a to Fig. 3b. The flow blocking diaphragm 41 can be turned up towards the direction of the lower disk surface 12. The locking structure 6 includes a locking column 61 located at the center of the upper panel surface 11. The locking column 61 is connected with the upper diaphragm 2, and the locking column 61 faces the lower panel surface 12. The end surface of the end face is provided with an insertion port 62 extending inward in the axial direction, the port of the insertion port 62 is provided with a first flange 63 extending radially inward, and the end of the clamping column 61 facing the lower disk surface 12 is also provided with a The second flange 64 extending radially outwards; after the inner core connecting rod 5 passes through the center surrounded by a plurality of choke diaphragms 41, it is then inserted into the insertion port 62, and the first flange 63 pushes the locking protrusion 51 stuck, so that the inner core connecting rod 5 and the clamping post 61 are stuck; after the inner core connecting rod 5 pulls the clamping post 61 and passes through the blocking film 4, the blocking diaphragm 41 blocks the second flange 64, Prevent the inner core connecting rod 5 from receding in the direction of the upper disk surface 11, so that the occluder can be stably fixed on the defect site. The end surface of the above-mentioned inner core connecting rod 5 facing the upper disk surface 11 is also provided with a middle groove 54, the design of the middle groove 54 can make the inner core connecting rod 5 snap into the insertion opening 62, and the locking protrusion 51 has a movable space in the radial direction , so that the inner core connecting rod 5 can be snapped into the insertion opening 62 more smoothly.

如图4a至图4c所示为该分瓣式可降解封堵器的第四种实施方式。阻流膜片41能向上盘面11的方向翻起,卡位结构6包括位于上盘面11的中心的卡位柱61,卡位柱61与上隔膜2连接,卡位柱61面向下盘面12的端面设有一个沿轴向向内延伸的插入口62,插入口62的周面设有沿周向延伸的凹口65;内芯连接杆5穿过多片阻流膜片41围成的中心后,再插入插入口62中,内芯连接杆5旋转后,卡位突起51卡入凹口65中,防止了内芯连接杆5的后退,使内芯连接杆5卡在卡位结构6上,封堵器能稳定地固定在缺损部位。Figure 4a to Figure 4c show the fourth embodiment of the split-valve degradable occluder. The flow blocking diaphragm 41 can be turned up towards the direction of the upper disk surface 11, and the locking structure 6 includes a locking column 61 located at the center of the upper panel surface 11. The locking column 61 is connected with the upper diaphragm 2, and the locking column 61 faces the bottom of the lower disk surface 12. The end face is provided with an insertion port 62 extending inward in the axial direction, and the peripheral surface of the insertion port 62 is provided with a notch 65 extending in the circumferential direction; After that, it is inserted into the insertion port 62. After the inner core connecting rod 5 rotates, the locking protrusion 51 snaps into the notch 65, which prevents the retreat of the inner core connecting rod 5, and makes the inner core connecting rod 5 stuck in the locking structure 6. On the other hand, the occluder can be stably fixed at the defect site.

如图6所示,内芯连接杆5位于下盘面12外部的端部设有沿径向贯穿的第一保险线穿孔52,内芯连接杆5位于下盘面12外部的端面设有沿轴向向内延伸的推杆连接孔53;推送杆9设有与推杆连接孔53配合的推送杆头部91和沿径向贯穿的第二保险线穿孔92。当该分瓣式可降解封堵器与推送杆9连接时,推送杆头部91插入推杆连接孔53中,保险线101穿过第一保险线穿孔52、第二保险线穿孔92,并与导丝10连接。为便于推送杆9与内芯连接杆5的紧固和转动,推送杆头部91的径向切面可以是圆形、三角形或外六角形等,推杆连接孔53设置为与推送杆头部91相对应的形状。As shown in Figure 6, the end of the inner core connecting rod 5 located outside the lower disk surface 12 is provided with a first insurance line perforation 52 penetrating in the radial direction, and the end surface of the inner core connecting rod 5 located outside the lower disk surface 12 is provided with an axial The push rod connection hole 53 extending inward; the push rod 9 is provided with a push rod head 91 matched with the push rod connection hole 53 and a second safety wire perforation 92 penetrating in the radial direction. When the split type degradable occluder is connected with the push rod 9, the push rod head 91 is inserted into the push rod connection hole 53, the safety wire 101 passes through the first safety wire perforation 52, the second safety wire perforation 92, and Connect with guide wire 10. In order to facilitate the fastening and rotation of the push rod 9 and the inner core connecting rod 5, the radial section of the push rod head 91 can be circular, triangular or outer hexagonal, etc., and the push rod connecting hole 53 is arranged to be aligned with the push rod head. 91 corresponding shapes.

该分瓣式可降解封堵器的使用方法,包括以下几步:The method for using the split-valve degradable occluder includes the following steps:

1)将封堵器与推送杆9连接;如图6所示,推送杆头部91插入推杆连接孔53中,保险线101穿过第一保险线穿孔52、第二保险线穿孔92,并与导丝10连接;1) The occluder is connected to the push rod 9; as shown in Figure 6, the push rod head 91 is inserted into the push rod connecting hole 53, and the safety wire 101 passes through the first safety wire perforation 52 and the second safety wire perforation 92, And be connected with guide wire 10;

2)将封堵器连同导丝10拉入输送鞘管8内,如图5所示;2) Pull the occluder together with the guide wire 10 into the delivery sheath 8, as shown in Figure 5;

3)将封堵器由输送鞘管8送至病变位置;3) sending the occluder to the lesion position through the delivery sheath 8;

4)将封堵器的上盘面11释放;4) Release the upper plate surface 11 of the occluder;

5)将封堵器的腰部13释放;5) releasing the waist 13 of the occluder;

6)等待血压将封堵器的上盘面11压向腰部13;6) Wait for the blood pressure to press the upper surface 11 of the occluder to the waist 13;

7)释放封堵器的下盘面12;7) release the lower plate surface 12 of the occluder;

8)将封堵器的内芯连接杆5与上盘面11的卡位结构6扣合,其中对应不同的卡位结构6,有不同的卡扣方式;8) Fasten the inner core connecting rod 5 of the occluder with the locking structure 6 of the upper panel surface 11, wherein corresponding to different locking structures 6, there are different buckling methods;

9)最后将推送杆9与封堵器分离,即完成了封堵器的安装。9) Finally, the push rod 9 is separated from the occluder, that is, the installation of the occluder is completed.

综上所述,本发明分瓣式可降解封堵器,针对的是高分子类可降解封堵装置,它通过结构方面的创新来补偿高分子材料的力学性能差所带来的一系列诸如回弹性、固定稳定性等问题。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。To sum up, the split-valve degradable occluder of the present invention is aimed at polymer degradable occlusion devices, and it uses structural innovations to compensate for a series of problems such as poor mechanical properties of polymer materials. Resilience, fixed stability and other issues. 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 shall still be covered by the claims of the present invention.

Claims (14)

1.一种分瓣式可降解封堵器,其特征在于:它包括网状支架(1),所述网状支架(1)由可降解丝线编织而成,所述网状支架(1)包括上盘面(11)、下盘面(12)和连接所述上盘面(11)、下盘面(12)的腰部(13),所述上盘面(11)缝有覆盖在上盘面(11)上的上隔膜(2),所述下盘面(12)缝有覆盖在下盘面(12)上的下隔膜(3),所述腰部(13)设有将腰部(13)横向拦截的阻流膜(4),所述阻流膜(4)的中间设有多片能翻起的瓣叶状的阻流膜片(41),所述多片阻流膜片(41)沿所述阻流膜(4)的中心的周向分布,所述多片阻流膜片(41)的能翻起的一端部分重叠在一起;所述上隔膜(2)、下隔膜(3)和阻流膜(4)由可降解材料制成,所述下盘面(12)的中间设有内芯连接杆(5),所述内芯连接杆(5)与下隔膜(3)连接在一起,所述上盘面(11)的中间设有卡位结构(6),所述内芯连接杆(5)能穿过所述阻流膜(4)卡在所述卡位结构(6)上。1. A split type degradable occluder is characterized in that: it comprises a mesh support (1), and the mesh support (1) is woven by degradable silk thread, and the mesh support (1) Comprising an upper panel (11), a lower panel (12) and a waist (13) connecting the upper panel (11) and the lower panel (12), the upper panel (11) is sewn with a seam covering the upper panel (11) The upper diaphragm (2) of the lower plate (12) is sewn with a lower diaphragm (3) covering the lower plate (12), and the waist (13) is provided with a flow blocking film ( 4), the middle of the choke film (4) is provided with a plurality of leaflet-shaped choke diaphragms (41) that can be turned up, and the plurality of choke diaphragms (41) are arranged along the (4) in the circumferential distribution of the center, one end part that can be turned up of the plurality of choke diaphragms (41) overlaps together; the upper diaphragm (2), the lower diaphragm (3) and the choke film ( 4) Made of degradable materials, the middle of the lower plate surface (12) is provided with an inner core connecting rod (5), and the inner core connecting rod (5) is connected with the lower diaphragm (3), and the upper A clamping structure (6) is provided in the middle of the disk surface (11), and the inner core connecting rod (5) can pass through the flow blocking film (4) and be clamped on the clamping structure (6). 2.根据权利要求1所述的分瓣式可降解封堵器,其特征在于:所述网状支架(1)所用的可降解丝线的材料为聚乳酸、聚己内酯、聚乙醇酸、聚对二氧环己酮或聚羟基丁酸。2. The split type degradable occluder according to claim 1, characterized in that: the material of the degradable thread used in the mesh support (1) is polylactic acid, polycaprolactone, polyglycolic acid, Polydioxanone or polyhydroxybutyrate. 3.根据权利要求1所述的分瓣式可降解封堵器,其特征在于:所述上隔膜(2)、下隔膜(3)和阻流膜(4)的材料为聚乳酸、聚乳酸-羟基乙酸共聚物或聚己内酯。3. The split-valve degradable occluder according to claim 1, characterized in that: the materials of the upper diaphragm (2), the lower diaphragm (3) and the blocking membrane (4) are polylactic acid, polylactic acid - glycolic acid copolymer or polycaprolactone. 4.根据权利要求1所述的分瓣式可降解封堵器,其特征在于:所述上隔膜(2)、下隔膜(3)或阻流膜(4)通过可降解缝线(7)与所述网状支架(1)缝在一起。4. The split-valve degradable occluder according to claim 1, characterized in that: the upper diaphragm (2), the lower diaphragm (3) or the flow blocking membrane (4) are passed through degradable sutures (7) Sewn together with the mesh bracket (1). 5.根据权利要求4所述的分瓣式可降解封堵器,其特征在于:所述缝线(7)的材料为二氧环已酮。5. The split-valve degradable occluder according to claim 4, characterized in that: the material of the suture (7) is dioxane. 6.根据权利要求4所述的分瓣式可降解封堵器,其特征在于:所述缝线(7)内混有显影物质。6. The split-valve degradable occluder according to claim 4, characterized in that: the suture (7) is mixed with a developing substance. 7.根据权利要求1所述的分瓣式可降解封堵器,其特征在于:所述内芯连接杆(5)内混有显影物质。7. The split-valve degradable occluder according to claim 1, characterized in that: the connecting rod (5) of the inner core is mixed with a developing substance. 8.根据权利要求1所述的分瓣式可降解封堵器,其特征在于:所述上盘面(11)的直径比腰部(13)的直径大6~16mm,所述下盘面(12)的直径比腰部(13)的直径大4~12mm。8. The split-flap degradable occluder according to claim 1, characterized in that: the diameter of the upper disc surface (11) is 6-16 mm larger than the diameter of the waist (13), and the lower disc surface (12) The diameter is 4~12mm larger than the diameter of the waist (13). 9.根据权利要求1所述的分瓣式可降解封堵器,其特征在于:所述内芯连接杆(5)位于所述下盘面(12)外部的端部设有沿径向贯穿的第一保险线穿孔(52),所述内芯连接杆(5)位于所述下盘面(12)外部的端面设有沿轴向向内延伸的推杆连接孔(53)。9. The split-flap degradable occluder according to claim 1, characterized in that: the end of the inner core connecting rod (5) located outside the lower disk surface (12) is provided with a radially penetrating The first safety wire is perforated (52), and the end surface of the inner core connecting rod (5) located outside the lower disk surface (12) is provided with a push rod connecting hole (53) extending axially inward. 10.根据权利要求1所述的分瓣式可降解封堵器,其特征在于:所述内芯连接杆(5)面向上盘面(11)的端部设有卡位突起(51),所述卡位突起(51)的直径大于所述内芯连接杆(5)的直径;所述内芯连接杆(5)穿过所述多片阻流膜片(41)围成的中心后,所述卡位突起(51)卡在所述上盘面(11)的卡位结构(6)上。10. The split-flap degradable occluder according to claim 1, characterized in that: the end of the inner core connecting rod (5) facing the upper disk surface (11) is provided with a locking protrusion (51), so The diameter of the clamping protrusion (51) is greater than the diameter of the inner core connecting rod (5); after the inner core connecting rod (5) passes through the center surrounded by the plurality of choke diaphragms (41), The locking protrusion (51) is locked on the locking structure (6) of the upper disk surface (11). 11.根据权利要求10所述的分瓣式可降解封堵器,其特征在于:所述阻流膜片(41)能向所述上盘面(11)的方向翻起,所述卡位结构(6)由位于所述上隔膜(2)的中心的多片能翻起的瓣叶状的卡位膜片(66)组成,所述多片卡位膜片(66)沿所述上盘面(11)的中心的周向分布,所述多片卡位膜片(66)的能翻起的一端部分重叠在一起;所述内芯连接杆(5)穿过所述多片阻流膜片(41)围成的中心后,再穿过多片卡位膜片(66)围成的中心,所述多片卡位膜片(66)将所述卡位突起(51)卡住。11. The split-flap degradable occluder according to claim 10, characterized in that: the flow blocking diaphragm (41) can be turned up toward the direction of the upper disk surface (11), and the locking structure (6) It consists of a plurality of leaflet-shaped retaining diaphragms (66) that can be turned up at the center of the upper diaphragm (2), and the plurality of retaining diaphragms (66) are positioned along the upper disk surface The circumferential distribution of the center of (11), the one end that can be turned up of the plurality of clamping diaphragms (66) is partially overlapped; the inner core connecting rod (5) passes through the plurality of flow blocking films After the center surrounded by the sheet (41), it passes through the center surrounded by a plurality of clamping membranes (66), and the multiple clamping membranes (66) clamp the clamping protrusion (51). 12.根据权利要求10所述的分瓣式可降解封堵器,其特征在于:所述阻流膜片(41)能向所述上盘面(11)的方向翻起,所述卡位结构(6)为位于所述上盘面(11)的上端面上的圆孔(67);所述内芯连接杆(5)穿过所述多片阻流膜片(41)围成的中心后,再穿过所述圆孔(67),所述圆孔(67)将所述卡位突起(51)卡住。12. The split-flap degradable occluder according to claim 10, characterized in that: the flow blocking diaphragm (41) can be turned up toward the direction of the upper disk surface (11), and the locking structure (6) is a circular hole (67) located on the upper end surface of the upper disk surface (11); after the inner core connecting rod (5) passes through the center surrounded by the plurality of choke diaphragms (41), , and then pass through the circular hole (67), and the circular hole (67) clamps the locking protrusion (51). 13.根据权利要求10所述的分瓣式可降解封堵器,其特征在于:所述阻流膜片(41)能向所述下盘面(12)的方向翻起,所述卡位结构(6)包括位于所述上盘面(11)的中心的卡位柱(61),所述卡位柱(61)与所述上隔膜(2)连接,所述卡位柱(61)面向下盘面(12)的端面设有一个沿轴向向内延伸的插入口(62),所述插入口(62)的端口设有沿径向向内延伸的第一凸缘(63),所述卡位柱(61)面向下盘面(12)的端部还设有沿径向向外延伸的第二凸缘(64);所述内芯连接杆(5)穿过所述多片阻流膜片(41)围成的中心后,再插入所述插入口(62)中,所述第一凸缘(63)将所述卡位突起(51)卡住,所述内芯连接杆(5)拉住所述卡位柱(61)穿过所述阻流膜(4)后,所述阻流膜片(41)将所述第二凸缘(64)卡住。13. The split-flap degradable occluder according to claim 10, characterized in that: the flow-blocking diaphragm (41) can be turned up toward the direction of the lower plate surface (12), and the locking structure (6) comprising a clamping column (61) located at the center of the upper disk surface (11), the clamping column (61) is connected to the upper diaphragm (2), and the clamping column (61) faces downward The end surface of the disc surface (12) is provided with an insertion port (62) extending axially inward, and the port of the insertion port (62) is provided with a first flange (63) extending radially inward. The end of the clamping post (61) facing the lower disk surface (12) is also provided with a second flange (64) extending radially outward; the inner core connecting rod (5) passes through the multi-piece flow blocking After the center surrounded by the diaphragm (41), it is inserted into the insertion port (62), the first flange (63) clamps the locking protrusion (51), and the inner core connecting rod ( 5) After pulling the clamping post (61) through the choke film (4), the choke film (41) clamps the second flange (64). 14.根据权利要求10所述的分瓣式可降解封堵器,其特征在于:所述阻流膜片(41)能向所述上盘面(11)的方向翻起,所述卡位结构(6)包括位于所述上盘面(11)的中心的卡位柱(61),所述卡位柱(61)与所述上隔膜(2)连接,所述卡位柱(61)面向下盘面(12)的端面设有一个沿轴向向内延伸的插入口(62),所述插入口(62)的周面设有沿周向延伸的凹口(65);所述内芯连接杆(5)穿过所述多片阻流膜片(41)围成的中心后,再插入所述插入口(62)中,所述内芯连接杆(5)旋转后,所述卡位突起(51)卡入所述凹口(65)中。14. The split-flap degradable occluder according to claim 10, characterized in that: the flow blocking diaphragm (41) can be turned up toward the direction of the upper disk surface (11), and the locking structure (6) comprising a clamping column (61) located at the center of the upper disk surface (11), the clamping column (61) is connected to the upper diaphragm (2), and the clamping column (61) faces downward The end surface of the disc surface (12) is provided with an insertion port (62) extending axially inward, and the peripheral surface of the insertion port (62) is provided with a notch (65) extending in the circumferential direction; the inner core is connected After the rod (5) passes through the center surrounded by the plurality of blocking diaphragms (41), it is inserted into the insertion port (62), and after the inner core connecting rod (5) rotates, the locking The protrusion (51) snaps into said recess (65).
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