WO2020221233A1 - 两端无外突点结构的封堵器 - Google Patents

两端无外突点结构的封堵器 Download PDF

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Publication number
WO2020221233A1
WO2020221233A1 PCT/CN2020/087406 CN2020087406W WO2020221233A1 WO 2020221233 A1 WO2020221233 A1 WO 2020221233A1 CN 2020087406 W CN2020087406 W CN 2020087406W WO 2020221233 A1 WO2020221233 A1 WO 2020221233A1
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WIPO (PCT)
Prior art keywords
line
occluder
necking
closing
mesh
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Ceased
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PCT/CN2020/087406
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English (en)
French (fr)
Inventor
张瑾
张健
孙锟
吴弘
马彩霞
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mallow Medical (shanghai) Co Ltd
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Mallow Medical (shanghai) Co Ltd
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Priority claimed from CN201920611275.7U external-priority patent/CN210494164U/zh
Priority claimed from CN201910355451.XA external-priority patent/CN111281462B/zh
Application filed by Mallow Medical (shanghai) Co Ltd filed Critical Mallow Medical (shanghai) Co Ltd
Priority to SG11202111063SA priority Critical patent/SG11202111063SA/en
Priority to EP20799407.0A priority patent/EP3932336A4/en
Priority to US17/604,254 priority patent/US20220192679A1/en
Priority to JP2021561972A priority patent/JP7539920B2/ja
Publication of WO2020221233A1 publication Critical patent/WO2020221233A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements 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
    • A61B2017/00575—Implements 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
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements 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
    • A61B2017/00575—Implements 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
    • A61B2017/00632—Occluding a cavity, i.e. closing a blind opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the invention relates to an occluder with no protruding point structure at both ends, which is used for the treatment of congenital heart disease, including atrial septal defect, patent ductus arteriosus, ventricular septal defect, patent foramen ovale, left atrial appendage, or blood vessels, etc. Blocking tissue cavities and other diseases that require blocking treatment.
  • one end of the occluder is generally provided with a connecting piece, and the connecting piece has an internal thread to connect with the conveyor to realize the delivery of the occluder. Because the internal thread processing is more difficult, and the production process will produce a higher rate of defective products, this will cause waste of raw materials and increase ineffective labor costs. With the development of the degradable occluder, it is difficult to manufacture the degradable occluder with threaded connections, so the method of this scheme can be used to manufacture the occluder with no external protrusion structure at both ends.
  • an occluder can also be implanted into the supply vessels of the diseased organs to occlude them and interrupt the blood supply to achieve the purpose of controlling bleeding and treating tumors and vascular diseases.
  • the occluder can also be placed in some tissue cavities to close the tissue cavities and cut off the delivery of internal materials.
  • the technical problem to be solved by the present invention is to overcome the disadvantages of the prior art that the connector of the occluder is difficult to manufacture and increase the manufacturing cost due to the threaded connection, and to provide an occluder with a structure without external protrusions at both ends.
  • a net-like body having a first closing end and a second closing end that are arranged oppositely;
  • a first necking line passing through a plurality of grids formed by the mesh at the first necking end to realize the closing of the first necking end;
  • a second necking line passing through a plurality of grids formed by the mesh at the second necking end to realize the closing of the second necking end.
  • neither the first closing end nor the second closing end has an external protrusion.
  • the absence of external protrusions at the first closing end and the second closing end means that the outer surface of the occlusion device where the two closing ends of the occlusion device are located is a flat and smooth surface.
  • the second necking line has a ring-shaped necking line, and the ring-shaped necking line passes through a plurality of grids formed by the mesh at the second necking end to achieve the Retracting, the ring-shaped retracting line is used as a connecting component to be connected to a conveyor that conveys the occluder with a structure with no external protrusions at both ends.
  • the second necking line has a ring-shaped necking line and a conveying line, and the ring-shaped necking line passes through a plurality of grids formed by the mesh at the second necking end to realize the first
  • the conveying line are respectively connected to the ring-shaped necking line so as to be connected to the conveyor that conveys the occluder with no external protrusion structure at both ends.
  • the conveying line can be easily connected by the connecting part of the conveyer, and conveying can be realized more reliably.
  • the material of the mesh body, the first necking line, and the second necking line are all implantable materials, and at least one selected from the following materials:
  • Metal and its alloy materials including stainless steel, cobalt-based alloys, titanium and titanium alloys, nickel-titanium alloy shape memory materials;
  • Non-degradable bio-inert medical polymer materials including nylon, polyester resin, polytetrafluoroethylene, ultra-high molecular weight polyethylene, high-density polyethylene, polymethyl methacrylate, polypropylene, polycarbonate, polyurethane , Silicone, polyacrylonitrile;
  • Degradable biomedical materials including polylactide, polyglycolide, polycaprolactone, polydioxanone, and copolymers or mixtures of these materials.
  • the material of the mesh body, the first necking line, and the second necking line can be selected from one or more materials under any one of the categories (1)-(3), or One or more materials selected from two or more categories of materials (1)-(3).
  • the mesh body is made by a method of mesh weaving or 3D printing.
  • a fiber fabric, non-woven fabric or film is arranged inside the occlusion device with no external protrusion structure at both ends.
  • the fiber fabric, non-woven fabric or film can be used for the climbing of endothelial tissue cells and increase the barrier of the device to blood or body fluids.
  • the occluders with no protruding point structure at both ends are: atrial septal defect occluder, patent ductus arteriosus occluder, ventricular septal defect occluder, patent foramen ovale occluder, Left atrial appendage occluder or vascular plug.
  • the occluder with no external protrusion structure at both ends disclosed in the present invention can be closed with a necking line at both ends to form a ring structure, and the necking line or the conveying line can be captured by the conveyor to realize the conveying of the occluder;
  • the prior art occluder with threaded connector, the solution of the present invention can reduce the processing difficulty, reduce the defective rate, and save the cost.
  • the occluder with no protruding point structure at both ends has good fit and can safely and effectively seal the heart defect or unclosed area.
  • the residual shunt after ultrasound examination can be greatly reduced, and it can also avoid or reduce the traditional two ends of platelets.
  • the occluder with no protruding point structure at both ends can also be used to treat tumors and vascular diseases.
  • the occluder is implanted into the supply vessel of the diseased organ to occlude it and interrupt the blood supply, in order to control bleeding and treat tumors. And the purpose of vascular disease.
  • the occluder with no protruding point structure at both ends can also be placed in some tissue cavities to close the tissue cavities and cut off the delivery of internal substances.
  • Fig. 1 is a schematic front view of an occluder with a structure without protruding points at both ends of embodiment 1 of the present invention.
  • Fig. 2 is a schematic rear view of the occlusion device with no protrusions at both ends of the embodiment 1 of the present invention.
  • Fig. 3 is an enlarged schematic view of the central part of Fig. 1.
  • Fig. 4 is a schematic bottom view of the occluder with no external protrusion structure at both ends of the embodiment 1 of the present invention.
  • Fig. 5 is a three-dimensional schematic diagram of the occlusion device with no external protrusion structure at both ends of the embodiment 1 of the present invention.
  • Fig. 6 is a partial three-dimensional schematic diagram of the occlusion device with a structure without protruding points at both ends of the embodiment 2 of the present invention at the second constricted end.
  • the occluder 1 with a structure without external protrusions at both ends includes a mesh body 10, a first necking line 20, and a second necking line 30.
  • the structure of the mesh body 10 is similar to that of the prior art, including two mesh disks, and both mesh disks are sewn with membranes for endothelial cells to climb.
  • the two mesh disks are both concave and have the same concave direction.
  • the mesh body 10 has a first narrowed end 11 and a second narrowed end 12 oppositely arranged, and the first narrowed end 11 and the second narrowed end 12 have no external protrusions.
  • the front end is the second narrow end 12
  • the first in FIG. 2 is the first narrow end 11.
  • the first necking line 20 passes through a plurality of grids formed by the mesh at the first necking end 11 to realize the necking of the first necking end 11.
  • the second necking line 30 passes through a plurality of grids formed by the mesh at the second necking end 12 to realize the necking of the second necking end 12.
  • the second necking line 30 has a ring-shaped necking line, and the ring-shaped necking line is threaded through a plurality of grids formed by the mesh at the second necking end 12 to realize the necking of the second necking end 12.
  • As a connecting component it is connected with the conveyor of the occluder with no external protrusion structure at both ends.
  • the material of the mesh body, the first necking line, and the second necking line are all implantable materials, specifically, nickel-titanium alloy shape memory materials.
  • the material of the mesh body, the first necking line, and the second necking line can also be made of metal and its alloy materials, such as one or more of stainless steel, cobalt-based alloys, titanium and titanium alloys.
  • non-degradable bio-inert medical polymer materials such as nylon, polyester resin, polytetrafluoroethylene, ultra-high molecular weight polyethylene, high-density polyethylene, polymethylmethacrylate, polypropylene, polycarbonate One or more of, polyurethane, silicone, polyacrylonitrile, etc.
  • biodegradable biomedical materials such as polylactide, polyglycolide, polycaprolactone, polydioxanone One or more or copolymers or mixtures of these materials.
  • both ends are closed with a necking line to form a ring structure, wherein the necking line at the proximal end can be captured by the conveyor to realize the delivery of the occluder.
  • the solution of this embodiment can reduce the risk of use and increase the speed of endothelialization.
  • first and second closing ends have no external protrusions.
  • the flat and smooth outer surface of the occluder with no external protrusions at both ends is more conducive to the climbing of endothelial cells, which will seal
  • the surface of the occluder rapidly forms endothelialization, which shortens the time of endothelialization, that is, shortens the postoperative recovery period; on the other hand, the occluder with no external protrusion structure at both ends causes minimal damage to the surrounding tissues.
  • the mesh body 10 is formed by weaving mesh. In other alternative embodiments, the mesh body 10 can also be produced by 3D printing.
  • the occluder with no protrusions at both ends is also provided with a film inside for the endothelial tissue cells to climb, and to increase the barrier of the device to blood or body fluids.
  • the inside of the occluder with no external protrusion structure at both ends can also be provided with fiber fabric or non-woven fabric to allow endothelial tissue cells to climb and increase the barrier of the device to blood or body fluids.
  • the occluder without protruding points at both ends can be: atrial septal defect occluder, patent ductus arteriosus occluder, ventricular septal defect occluder, patent foramen ovale occluder, left atrial appendage occluder or Vascular plugs can also be other medical devices that close tissue cavities.
  • this embodiment 2 is similar to embodiment 1, except that: in embodiment 1, the second necking line 30 only includes a ring necking line, while in this embodiment 2, the second necking line 30 It has an annular necking line 31 and a conveying line 32.
  • the ring-shaped necking line 31 passes through a plurality of grids formed by the mesh at the second necking end 12 to realize the necking of the second necking end 12, and both ends of the conveying line 32 are respectively connected to the ring-shaped necking line 31 to be connected with each other.
  • the conveyer of the occluder 1 with no external protrusion structure at the conveying ends is connected.
  • the conveying line 32 can be easily connected by the connecting part of the conveyer, and conveying can be realized more reliably.
  • the structure of the conveying line 32 can be set to various structures according to actual needs, such as a semi-circular structure, a U-shaped structure, etc., as long as the conveying line 32 can be connected to the ring-shaped necking line 31 to achieve the two ends of the conveying
  • ring-shaped neckline 31 is shown to be thicker than it actually is.

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Abstract

一种两端无外突点结构的封堵器（1），其中包括网状体（10）；第一收口线（20），第一收口线（20）穿设于由第一收口端（11）处的网丝构成的多个网格，以实现第一收口端（11）的收口；第二收口线（30），第二收口线（30）穿设于由第二收口端（12）处的网丝构成的多个网格，以实现第二收口端（12）的收口。相较于现有技术的具有带螺纹连接件的封堵器，本方案可以降低加工难度，降低次品率，节约成本。

Description

两端无外突点结构的封堵器
本申请要求申请日为2019/4/29的中国专利申请201910355451X以及2019206112757的优先权。本申请引用上述中国专利申请的全文。
技术领域
本发明涉及一种两端无外突点结构的封堵器，用于治疗先心病，含房间隔缺损、动脉导管未闭、室间隔缺损、卵圆孔未闭、左心耳，或血管、其他封堵组织腔体等需要封堵治疗的病症。
背景技术
现有技术中，封堵器的一端一般会带有一个连接件，连接件具有内螺纹，以与输送器相连接从而实现封堵器的输送。由于内螺纹加工难度较高，而且生产过程中会产生较高的次品率，这样会造成原材料的浪费和无效人工成本的提高。随着可降解封堵器的发展，由于制作带有螺纹连接件的可降解封堵器较难制作，所以可以采用本方案的方法制作两端无外突点结构的封堵器。在治疗肿瘤和血管性病变时，也可以用封堵器植入病变器官的供应血管内，使之发生闭塞，中断血供，以期达到控制出血、治疗肿瘤和血管性病变的目的。封堵器还可以放在一些组织腔体中，以闭合组织腔体，截断内部物质的输送。
综上，现有技术中由于封堵器的连接件带有螺纹而难于制作和增加制造成本。
发明内容
本发明要解决的技术问题是为了克服现有技术的由于封堵器的连接件带有螺纹而难于制作和增加制造成本的缺陷，提供一种两端无外突点结构的 封堵器。
本发明是通过下述技术方案来解决上述技术问题：
一种两端无外突点结构的封堵器，其特点在于，其包括有：
网状体，所述网状体具有相对设置的第一收口端和第二收口端；
第一收口线，所述第一收口线穿设于由所述第一收口端处的网丝构成的多个网格，以实现所述第一收口端的收口；
第二收口线，所述第二收口线穿设于由所述第二收口端处的网丝构成的多个网格，以实现所述第二收口端的收口。
较佳地，所述第一收口端和所述第二收口端均无外突点。
在本方案中，第一收口端和第二收口端均无外突点指的是：封堵器两收口端所在的封堵器的外表面是平整光滑的表面。采用上述设置，一方面，该两端无外突点结构的封堵器平整光滑的外表面更加有利于内皮细胞的攀爬，这样会在封堵器表面快速地形成内皮化，缩短内皮化时间，也就是缩短术后恢复期；另一方面，该两端无外突点结构的封堵器对周围组织的损伤极小。
较佳地，所述第二收口线具有环状收口线，所述环状收口线穿设于由所述第二收口端处的网丝构成的多个网格以实现所述第二收口端的收口，所述环状收口线作为连接部件与输送所述两端无外突点结构的封堵器的输送器相连接。
较佳地，所述第二收口线具有环状收口线和输送线，所述环状收口线穿设于由所述第二收口端处的网丝构成的多个网格以实现所述第二收口端的收口，所述输送线的两端分别连接于所述环状收口线以与输送所述两端无外突点结构的封堵器的输送器相连接。
采用上述设置，输送线可以容易地被输送器的连接部件衔接，更可靠地实现输送。
较佳地，所述网状体、第一收口线、第二收口线的材质均为可植入材料，且选自下述材料中的至少一种：
(1)金属及其合金材料，包括不锈钢、钴基合金、钛及钛合金、镍钛合金形状记忆材料；
(2)不可降解的生物惰性医用高分子材料，包括尼龙、涤纶树脂、聚四氟乙烯、超高分子量聚乙烯、高密度聚乙烯、聚甲基丙烯酸甲酯、聚丙烯、聚碳酸酯、聚氨酯、有机硅、聚丙烯腈；
(3)可降解生物医用材料，包括聚丙交酯、聚乙交酯、聚己内酯、聚对二氧环己酮，及这些材料的共聚物或混合物。
需要说明的是，网状体、第一收口线、第二收口线的材质可以选自第(1)-(3)种材质中的任意一种分类下的一种或多种材质，也可以选自第(1)-(3)种材质中的两种或多种分类下的一种或多种材质。
较佳地，所述网状体由网丝编织或3D打印的方法制作。
较佳地，所述两端无外突点结构的封堵器的内部设置有纤维织物、无纺布或薄膜。
采用上述设置，纤维织物、无纺布或薄膜可以供内皮组织细胞攀爬，并增加器械对血液或体液的阻挡。
较佳地，所述两端无外突点结构的封堵器为：房间隔缺损封堵器、动脉导管未闭封堵器、室间隔缺损封堵器、卵圆孔未闭封堵器、左心耳封堵器或血管塞。
在符合本领域常识的基础上，上述各优选条件，可任意组合，即得本发明各较佳实例。
本发明的积极进步效果在于：
本发明公开的两端无外突点结构的封堵器，两端可以均用收口线收口为环形结构，收口线或输送线可以被输送器抓捕以实现封堵器的输送；相较于现有技术的具有带螺纹连接件的封堵器，本发明的这种方案可以降低加工难度，降低次品率，节约成本。两端无外突点结构的封堵器贴合性好，可以安全有效地封堵心脏缺损或未闭处，术后超声检查残留分流可极大地降低，还 可避免或减少血小板在传统两端有铆型封堵器上裸露的铆点处的附着，从而减少封堵器局部血栓形成的风险，从根本上减少封堵器术后并发症的发生。两端无外突点结构的封堵器也可以用于治疗肿瘤和血管性病变，封堵器植入病变器官的供应血管内，使之发生闭塞，中断血供，以期达到控制出血、治疗肿瘤和血管性病变的目的。两端无外突点结构的封堵器还可以放在一些组织腔体中，以闭合组织腔体，截断内部物质的输送。
附图说明
图1为本发明实施例1的两端无外突点结构的封堵器的主视示意图。
图2为本发明实施例1的两端无外突点结构的封堵器的后视示意图。
图3为图1的中心部分的放大示意图。
图4为本发明实施例1的两端无外突点结构的封堵器的仰视示意图。
图5为本发明实施例1的两端无外突点结构的封堵器的立体示意图。
图6为本发明实施例2的两端无外突点结构的封堵器在第二收口端处的局部立体示意图。
附图标记说明
1：两端无外突点结构的封堵器
10：网状体
11：第一收口端
12：第二收口端
20：第一收口线
30：第二收口线
31：环状收口线
32：输送线
具体实施方式
下面举个较佳实施例，并结合附图来更清楚完整地说明本发明。
实施例1
如图1-5所示，两端无外突点结构的封堵器1包括有：网状体10、第一收口线20和第二收口线30。网状体10的结构与现有技术类似，包括两个网盘，且两个网盘内均缝有供内皮细胞攀爬的膜。本实施例中，两个网盘均呈凹陷状且凹陷方向相同。
网状体10具有相对设置的第一收口端11和第二收口端12，第一收口端11和第二收口端12均无外突点。如图1在前的为第二收口端12，图2中在前的为第一收口端11。第一收口线20穿设于由第一收口端11处的网丝构成的多个网格，以实现第一收口端11的收口。第二收口线30穿设于由第二收口端12处的网丝构成的多个网格，以实现第二收口端12的收口。其中，第二收口线30具有环状收口线，环状收口线穿设于由第二收口端12处的网丝构成的多个网格以实现第二收口端12的收口，环状收口线作为连接部件与输送两端无外突点结构的封堵器的输送器相连接。
本实施例中，网状体、第一收口线、第二收口线的材质均为可植入材料，具体地为镍钛合金形状记忆材料。在其他可替代的实施方式中，网状体、第一收口线、第二收口线的材质也可采用金属及其合金材料，如不锈钢、钴基合金、钛及钛合金中的一种或多种，也可采用不可降解的生物惰性医用高分子材料，如尼龙、涤纶树脂、聚四氟乙烯、超高分子量聚乙烯、高密度聚乙烯、聚甲基丙烯酸甲酯、聚丙烯、聚碳酸酯、聚氨酯、有机硅、聚丙烯腈等中的一种或多种，也可采用可降解生物医用材料，如聚丙交酯、聚乙交酯、聚己内酯、聚对二氧环己酮中的一种或多种或这些材料的共聚物或混合物。
以上，两端均用收口线收口为环形结构，其中近端的收口线可以被输送器抓捕以实现封堵器的输送，相较于现有技术的具有带螺纹连接件的封堵器，本实施例的这种方案可以减小使用风险，增快内皮化速度。
另外，第一收口端和第二收口端均无外突点，一方面，该两端无外突点结构的封堵器平整光滑的外表面更加有利于内皮细胞的攀爬，这样会在封堵器表面快速地形成内皮化，缩短内皮化时间，也就是缩短术后恢复期；另一方面，该两端无外突点结构的封堵器对周围组织的损伤极小。
在本实施例中，网状体10由网丝编制成型。在其他可替代的实施方式中，网状体10也可通过3D打印的方法制作。
另外，在本实施例中，两端无外突点结构的封堵器的内部还设置有薄膜，以供内皮组织细胞攀爬，并增加器械对血液或体液的阻挡。在其他可替代的实施例中，两端无外突点结构的封堵器的内部还可以设置有纤维织物或无纺布，以供内皮组织细胞攀爬，并增加器械对血液或体液的阻挡。
两端无外突点结构的封堵器可以为：房间隔缺损封堵器、动脉导管未闭封堵器、室间隔缺损封堵器、卵圆孔未闭封堵器、左心耳封堵或血管塞，也可以为其他关闭组织腔体的医疗器械。
实施例2
如图6所示，本实施例2与实施例1类似，不同之处在于：实施例1中，第二收口线30仅包括环状收口线，而本实施例2中，第二收口线30具有环状收口线31和输送线32。环状收口线31穿设于由第二收口端12处的网丝构成的多个网格以实现第二收口端12的收口，输送线32的两端分别连接于环状收口线31以与输送两端无外突点结构的封堵器1的输送器相连接。
输送线32可以容易地被输送器的连接部件衔接，更可靠地实现输送。
需要说明的是，关于输送线32的结构，可以根据实际需要设置为各种结构，比如半环形结构，U型结构等，只要输送线32能够与环状收口线31连接，实现与输送两端无外突点结构的封堵器1的输送器相连接即可。
图6中仅是出于示意的目的，环状收口线31示出为比实际更粗。
在本发明的描述中，一个实施例可能配有多张附图，同一实施例中的同一部件的附图标记不一定在每一张附图中均标出；但是本领域技术人员应当 理解，在对实施例中的某一张或多张附图进行描述的时候，可以结合该实施例中的其他附图加以理解；本领域技术人员应当理解，在未指明文字具体对应的是哪一张附图时，可以结合该实施例中的所有附图加以理解。
在本发明的描述中，需要理解的是，术语“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这些仅是举例说明，在不背离本发明的原理和实质的前提下，可以对这些实施方式做出多种变更或修改。因此，本发明的保护范围由所附权利要求书限定。

Claims (8)

  1. 一种两端无外突点结构的封堵器，其特征在于，其包括有：
    网状体，所述网状体具有相对设置的第一收口端和第二收口端；
    第一收口线，所述第一收口线穿设于由所述第一收口端处的网丝构成的多个网格，以实现所述第一收口端的收口；
    第二收口线，所述第二收口线穿设于由所述第二收口端处的网丝构成的多个网格，以实现所述第二收口端的收口。
  2. 如权利要求1所述的两端无外突点结构的封堵器，其特征在于，所述第一收口端和所述第二收口端均无外突点。
  3. 如权利要求1所述的两端无外突点结构的封堵器，其特征在于，所述第二收口线具有环状收口线，所述环状收口线穿设于由所述第二收口端处的网丝构成的多个网格以实现所述第二收口端的收口，所述环状收口线作为连接部件与输送所述两端无外突点结构的封堵器的输送器相连接。
  4. 如权利要求1所述的两端无外突点结构的封堵器，其特征在于，所述第二收口线具有环状收口线和输送线，所述环状收口线穿设于由所述第二收口端处的网丝构成的多个网格以实现所述第二收口端的收口，所述输送线的两端分别连接于所述环状收口线以与输送所述两端无外突点结构的封堵器的输送器相连接。
  5. 如权利要求1所述的两端无外突点结构的封堵器，其特征在于，所述网状体、第一收口线、第二收口线的材质均为可植入材料，且选自下述材料中的至少一种：
    (1)金属及其合金材料，包括不锈钢、钴基合金、钛及钛合金、镍钛合金形状记忆材料；
    (2)不可降解的生物惰性医用高分子材料，包括尼龙、涤纶树脂、聚四氟乙烯、超高分子量聚乙烯、高密度聚乙烯、聚甲基丙烯酸甲酯、聚丙烯、 聚碳酸酯、聚氨酯、有机硅、聚丙烯腈；
    (3)可降解生物医用材料，包括聚丙交酯、聚乙交酯、聚己内酯、聚对二氧环己酮，及这些材料的共聚物或混合物。
  6. 如权利要求1所述的两端无外突点结构的封堵器，其特征在于，所述网状体由网丝编织或3D打印的方法制作。
  7. 如权利要求1所述的两端无外突点结构的封堵器，其特征在于，所述两端无外突点结构的封堵器的内部设置有纤维织物、无纺布或薄膜。
  8. 如权利要求1-7中任一项所述的两端无外突点结构的封堵器，其特征在于，所述两端无外突点结构的封堵器为：房间隔缺损封堵器、动脉导管未闭封堵器、室间隔缺损封堵器、卵圆孔未闭封堵器、左心耳封堵器或血管塞。
PCT/CN2020/087406 2019-04-29 2020-04-28 两端无外突点结构的封堵器 Ceased WO2020221233A1 (zh)

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