WO2024113862A1 - 卵圆孔未闭封堵器 - Google Patents

卵圆孔未闭封堵器 Download PDF

Info

Publication number
WO2024113862A1
WO2024113862A1 PCT/CN2023/105252 CN2023105252W WO2024113862A1 WO 2024113862 A1 WO2024113862 A1 WO 2024113862A1 CN 2023105252 W CN2023105252 W CN 2023105252W WO 2024113862 A1 WO2024113862 A1 WO 2024113862A1
Authority
WO
WIPO (PCT)
Prior art keywords
foramen ovale
patent foramen
disc
ovale occluder
disc body
Prior art date
Application number
PCT/CN2023/105252
Other languages
English (en)
French (fr)
Inventor
阮成民
邓嘉铭
Original Assignee
广东脉搏医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 广东脉搏医疗科技有限公司 filed Critical 广东脉搏医疗科技有限公司
Publication of WO2024113862A1 publication Critical patent/WO2024113862A1/zh

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a patent foramen ovale occluder.
  • Patent foramen ovale is a common congenital heart disease.
  • the mainstream treatment method is to use an occluder for percutaneous (femoral vein) occlusion (i.e., PFO occlusion).
  • PFO occlusion percutaneous occlusion
  • the occluder is one of the most important medical devices.
  • the commonly used atrial septal occluders and PFO occluders are both dense mesh structures woven with nickel-titanium alloy wires.
  • the occluder has a large area.
  • the main purpose of the present application is to provide a patent foramen ovale occluder to solve the problem in the prior art that patients cannot undergo atrial septal puncture after PFO closure surgery.
  • the present application provides a patent foramen ovale occluder, comprising: at least two disk bodies, which are integrally arranged between the disk bodies and form an integral part, the disk body comprises a plurality of silk threads, each silk thread is spirally twisted and together forms a disk body having at least one layer of structure and in a flower shape, a gap is formed between the silk threads, the size of the gap is greater than or equal to the size of a predetermined delivery sheath, so that the delivery sheath can pass through the gap to pass through the patent foramen ovale occluder; a connecting piece, the connecting piece is located at the central end of the disk body, the connecting piece is used to recover the silk threads, and the ends of the silk threads are gathered at the connecting piece; a flow-blocking membrane, the flow-blocking membrane is attached to the outer surface of the disk body and blocks the gap.
  • the gap forms an inscribed circle, and the diameter of the inscribed circle is greater than or equal to a predetermined diameter of the delivery sheath.
  • the disc body includes a plurality of petal structures formed by silk threads, and the petal structures are arranged in abutment with each other in sequence along the circumference of the disc body, and gaps are formed among the petal structures.
  • each wire forms at least one petal structure.
  • the wire extends radially outward from the middle of the disk body for a predetermined distance, then bends and extends circumferentially. After extending circumferentially for a predetermined distance, the wire bends and extends radially to the middle of the disk body. During the process of radial extension and/or circumferential extension of the wire, the wire extends axially to form a double-layer structure.
  • the area between two radially extending wires in each petal structure serves as a gap.
  • the disc body includes a plurality of petal structures formed by silk threads, each petal structure is arranged along the circumference of the disc body, and at least a portion of the circumference of each petal structure is axially overlapped to form a double-layer structure.
  • two adjacent petal structures located in the same layer are sequentially butt-jointed along the circumference of the disc body, and a gap is formed between the overlapping parts of the two axially overlapping petal structures.
  • the patent foramen ovale occluder further includes a connecting structure, and the two circumferentially butted petal structures are connected together via the connecting structure.
  • the wires at the butt joint of two circumferentially butted petal structures are entangled together.
  • the number of wires in each disc is 6-8.
  • the disk body includes a plurality of petal structures formed by silk threads, the disk bodies are axially arranged relative to each other, and the two axially corresponding petal structures between two axially adjacent disk bodies are formed by the same or several silk threads, and a spiral, linear or braided transition section is formed by the silk threads between two axially adjacent disk bodies.
  • the wire is a nickel-titanium alloy wire.
  • the cross-sectional diameter of the wire is 0.20-0.40 mm.
  • the disc body is concave between the center and the edge, and the center is closer to the distal end than the edge, and the concave directions of the disc bodies are the same.
  • the disc body has at least a two-layer structure.
  • At least one disk is a single-layer structure, and the disk with the single-layer structure is concave between the center and the edge.
  • a flower-shaped disc is formed by winding silk threads, and the silk threads are not densely arranged to form a dense mesh structure, but are spaced apart by a large distance to form a gap, and the size of the gap is adapted to the size of the delivery sheath, so that the delivery sheath can pass through the gap, and thus can pass through the disc, and achieve the possibility of puncturing the atrial septum to deliver the sheath into the left atrium, retaining the opportunity for minimally invasive interventional treatment of atrial fibrillation, mitral regurgitation and other diseases.
  • the structure of the disc can ensure that the patent foramen ovale occluder can ensure its fixing effect, and the flow-blocking membrane set on the surface of the disc can achieve the occlusion effect of the patent foramen ovale occluder, which plays a role in preventing blood from passing through and accelerating the endothelialization process, and the setting of the connector can, on the one hand, bring together the ends of the silk threads, and on the other hand, the connector can also cooperate with the external operating components to achieve the function of operating the patent foramen ovale occluder.
  • the above-mentioned setting method under the premise of ensuring the normal use of the patent foramen ovale occluder, enables the patent foramen ovale occluder to increase the function of allowing the delivery sheath to pass through, retains the possibility of puncturing the atrial septum, and provides minimally invasive interventional treatment. It provides opportunities for diseases such as atrial fibrillation and mitral regurgitation, and also has the functions of reducing the risk of thrombosis on the device, rapid endothelialization, and reducing nickel ion release.
  • FIG1 is a schematic structural diagram of a patent foramen ovale occluder according to Embodiment 1 of the present application;
  • FIG2 shows a front view of FIG1 ;
  • FIG3 shows a top view of a patent foramen ovale occluder according to Embodiment 2 of the present application
  • FIG4 shows a schematic structural diagram of a patent foramen ovale occluder according to Embodiment 3 of the present application
  • FIG5 shows a front view of FIG4 ;
  • FIG6 shows a top view of FIG4 ;
  • FIG7 shows a schematic structural diagram of a patent foramen ovale occluder according to Embodiment 4 of the present application.
  • FIG8 shows a front view of FIG7
  • FIG9 shows a top view of FIG7 ;
  • FIG10 is a schematic structural diagram of a patent foramen ovale occluder according to Embodiment 5 of the present application.
  • FIG11 shows a front view of FIG10 ;
  • FIG. 12 shows a top view of FIG. 10 .
  • a patent foramen ovale occluder comprises at least two disc bodies 10, a connector 20 and a flow-blocking membrane.
  • the disc bodies 10 are integrally arranged to form a whole piece.
  • the disc body 10 comprises a plurality of wires 11, each of which is spirally wound and together forms a
  • a flower-shaped disc body 10 having at least one layer of structure is formed, gaps 12 are formed between the silk threads 11, and the size of the gaps 12 is greater than or equal to the size of a predetermined delivery sheath, so that the delivery sheath can pass through the gaps 12 to pass through the patent foramen ovale occluder;
  • a connector 20 is located at the central end of the disc body 10, and the connector 20 is used to recycle the silk threads 11, and the ends of the silk threads 11 are gathered at the connector 20;
  • a flow-blocking membrane is attached to the outer surface of the disc body 10 and blocks the gaps 12.
  • the flower-shaped disc 10 is formed by winding the silk thread 11, and the silk threads 11 are not densely arranged to form a dense network structure, but the silk threads 11 are spaced at a large distance to form a gap 12, and the size of the gap 12 is adapted to the size of the delivery sheath, so that the delivery sheath can pass through the gap 12, thereby passing through the disc 10, and realizing the possibility of puncturing the atrial septum to deliver the sheath into the left atrium, retaining the opportunity of minimally invasive interventional treatment of diseases such as atrial fibrillation and mitral regurgitation.
  • the structure of the disc 10 can ensure that the patent foramen ovale occluder can ensure its fixing effect, and the blocking membrane set on the surface of the disc 10 can achieve the blocking effect of the patent foramen ovale occluder, which plays a role in preventing blood from passing and accelerating the endothelialization process.
  • the setting of the connector 20 can, on the one hand, gather the ends of the silk threads 11, and on the other hand, the connector 20 can also cooperate with the external operating components to achieve the function of operating the patent foramen ovale occluder.
  • the above-mentioned setting method while ensuring the normal use of the patent foramen ovale occluder, enables the patent foramen ovale occluder to increase the function of allowing the delivery sheath to pass through, retaining the possibility of penetrating the atrial septum, providing an opportunity for minimally invasive interventional treatment of diseases such as atrial fibrillation and mitral regurgitation, while also having the functions of reducing the risk of thrombosis on the device, rapid endothelialization, and reducing the release of nickel ions.
  • two disc bodies 10 are provided as an example, and the two disc bodies 10 are axially oppositely arranged, and each disc body 10 forms a double-layer structure.
  • the patent foramen ovale occluder forms a double-disc double-layer structure.
  • the delivery sheath is circular and the shape of the gap 12 may be various, to ensure that the delivery sheath can pass through the gap 12, the two can be matched by ensuring that the diameter of the inscribed circle formed by the gap 12 is greater than or equal to the predetermined diameter of the delivery sheath.
  • the disk body 10 of this embodiment is in the shape of a flower as a whole, and mainly includes a plurality of petal structures, each of which is arranged circumferentially to form a flower shape, and the petal structure is formed by winding the silk thread 11, so that the disk body 10 is a frame structure as a whole, thereby forming a gap 12.
  • the petal structures of this embodiment are sequentially butted along the circumference of the disk body 10, and the silk threads 11 are butted together at the edges between two adjacent petal structures, thereby forming the disk body 10.
  • the gap 12 is formed by the petal structure itself, that is, the space in the middle of the frame-type petal structure itself is the gap 12.
  • each petal structure and the specific shape of the flower shape can be adjusted as needed and are not limited to the structural form given in this embodiment.
  • the petal structure can be formed by one thread 11 or multiple threads 11.
  • each thread 11 can form one petal structure or multiple petal structures.
  • the present embodiment uses each thread 11 to form two petal structures, and the two petal structures are two petal structures axially opposite to each other on the two disc bodies 10.
  • a petal structure is first taken as an example.
  • One end of the thread 11 is connected to the connecting piece 20 in the middle of the disc body 10.
  • the thread 11 starts from the connecting piece 20 and extends radially outward from the disc body 10, that is, in a direction away from the center of the disc body 10, for a predetermined distance.
  • the thread 11 is bent and changes direction to extend circumferentially along the disc body 10.
  • the thread 11 is bent again and extends radially inward from the disc body 10, that is, toward the middle of the disc body 10, until it extends to the disc body 10. in the middle part, so that a petal structure can be formed.
  • the silk thread 11 can simultaneously extend axially for a distance, so that one silk thread 11 can form a double-layer structure with two axial layers.
  • other silk threads 11 form their own petal structures in sequence, and the petal structures on the same disk body 10 are arranged circumferentially in sequence, and the radially extending silk thread 11 segments of each petal structure are butt-jointed together to form the entire disk body 10.
  • the gap 12 is the area between the two radially extending segments of the silk thread 11 in each petal structure.
  • the tray body 10 of this embodiment adopts a two-layer structure.
  • the tray body 10 can also be provided with more layers as needed.
  • the reason why the tray body 10 is provided with a double-layer structure in this embodiment is that it is not necessary to consider the length of the channel between the secondary septum and the primary septum when the foramen ovale is blocked.
  • the common channel is inclined, that is, not directly facing each other, so the two tray bodies 10 will be staggered when blocked.
  • the double-layer structure is not easy to warp, and when the misaligned blockage is performed, a good blocking effect can still be maintained.
  • each disc 10 is axially arranged relative to each other, and the two axially corresponding petal structures between two axially adjacent discs 10 are formed by the same or several silk threads 11.
  • This embodiment adopts a method of forming by the same silk thread 11. Specifically, this embodiment forms a spiral woven transition section 13 by the silk thread 11 between two axially adjacent discs 10. That is, after the above-mentioned petal structure is formed, the silk thread 11 radially extending to the middle of the disc 10 is wound around the middle between the two discs 10 to form a woven structure.
  • This part of the silk thread 11 is the transition section 13, which plays a role in transitionally connecting the two discs 10 to form an integral part.
  • the spirally woven silk thread 11 extends to the position of another disk body 10, and then repeats the previous process of forming the petal structure, first extending radially, then extending circumferentially, and finally extending radially to the center of the disk body 10, and winding with other silk threads 11 and recovering at the transition section 13.
  • the relative relationship and the relationship of approach and distance of the radially extending wires 11 are also consistent, that is, in the two relatively disk bodies 10, the axial extension direction of the wires 11 of the two petal structures is the same, and they extend toward one side of the disk body 10 at the same time, so that the two petal structures formed by one wire 11 are arranged in the same axial direction, and only the specific distance of the axial extension is different, thereby forming a concave shape.
  • the specific setting method is not limited to the above-mentioned method of this embodiment, and can also be set to other structural forms as needed.
  • each disc 10 has eight threads 11 .
  • the eight threads 11 make each disc 10 form eight petal structures.
  • Each petal structure occupies a 45° range in the circumferential direction of the disc 10. That is, the central angle of the gap 12 approximately in the fan shape is 45°.
  • the diameter specification of the patent foramen ovale occluder ranges from 1818 to 3030.
  • the minimum gap is 31.8 mm 2 and the maximum gap is 88.4 mm 2 calculated by the 45° fan shape.
  • the maximum diameter of the inscribed circle is about 8.5 mm and the minimum is about 5.2 mm. It can pass through a delivery sheath with an outer diameter of at least 15F.
  • the maximum diameter that can be passed through the delivery sheath is 25F.
  • F represents the circumference
  • 3F the circumference corresponding to the delivery sheath with a diameter of 1mm
  • the delivery sheath with a diameter of 15F can pass through the delivery sheath with a diameter of 5mm.
  • the number of threads 11 can be adjusted as needed, and the number of threads 11 in each disc 10 is 6-8, and the rope-like structure formed by them is also 6-8 strands.
  • the number of threads 11 in each disc 10 is the number of threads 11 of the entire patent foramen ovale occluder.
  • the wire 11 of the present embodiment is a nickel-titanium alloy wire, and the cross-sectional diameter of a single wire 11 is 0.20-0.40 mm.
  • the thickening of the nickel-titanium alloy wire can ensure the clamping force of the patent foramen ovale occluder, avoid the situation where the clamping force is reduced due to the reduction of the wire 11, and ensure the normal use of the patent foramen ovale occluder.
  • the flow-blocking membrane of this embodiment adopts a polymer braided membrane, which is very thin and can be easily penetrated by the atrial septal puncture needle.
  • the ePTFE coating process is carried out on the inner side of the double layer.
  • the water drop angle on the surface of the ePTFE is changed, so that the originally stable ePTFE has good hot melt properties, which completely prevents the blood from the right atrium from flowing to the left atrium to form a thrombus.
  • ePTFE has good biocompatibility.
  • the pore size of the flow-blocking membrane is preferably 160 ⁇ 30 ⁇ m, so that it can better promote the process of endothelialization while the atrial septal puncture needle can easily pass through.
  • the connector 20 of this embodiment adopts a recycling nut, and one recycling nut is provided, which is located at the center of one disc body 10, while the middle part of the other disc body 10 is not provided with a connector 20, and the wires 11 thereof can be entangled together to form a rivet-free structure.
  • the patent foramen ovale occluder as a whole forms a single-rivet double-layer structure.
  • the disc 10 is concave between the center and the edge, and the center is closer to the distal end than the edge, that is, the center protrudes toward the distal end, and the opening side of the concave faces away from the distal end (the so-called distal end in the medical field is the end away from the operator's hand), and the concave direction of each disc 10 is the same. In this way, it is convenient to release the occluder from the delivery sheath without increasing the size of the delivery sheath.
  • two adjacent petal structures are connected by winding together.
  • two radially extending threads 11 between two adjacent petal structures that is, the threads 11 at the butt joints of the two circumferentially butted petal structures are twisted together in an interlaced and winding manner to form a rope-like structure (only part of the threads are shown to be wound together in FIG3 ).
  • the overall structure can achieve a firm connection between the various parts without the aid of external components.
  • the difference from the first embodiment is that the manner in which the petal structures are butted against each other is different.
  • the patent foramen ovale occluder also includes a connecting structure 30, which can be a suture, a connecting wire, or the like.
  • the wires 11 of the two circumferentially connected petal structures are not entangled together, but are directly arranged in parallel. The two are connected together by the connecting structure 30 to form the entire disc body 10.
  • two recovery nuts are provided in this embodiment and are respectively located at the center of the two disks 10 , so that they can cooperate with the silk thread 11 and external components, so that the patent foramen ovale occluder has a double-rivet double-layer structure.
  • the thread 11 between two adjacent petal structures in the first embodiment can be wound to form a rope-like structure in the manner of the second embodiment, or can be connected in the manner of the third embodiment, and the manner of the second embodiment is preferred.
  • the difference from the first embodiment is that the number of wires 11 is different.
  • each disc body 10 forms six petal structures.
  • Each petal structure occupies 60° of the circumference of the disc body 10, that is, the central angle of the gap 12 approximately in the fan shape is 60°.
  • the diameter specification of the patent foramen ovale occluder ranges from 1818 to 3030.
  • the minimum gap is 42.39 mm 2 and the maximum gap is 117.75 mm 2 calculated by the 60° fan shape.
  • the maximum diameter of the inscribed circle is about 9.81 mm and the minimum is about 5.96 mm. It can pass through a delivery sheath tube with an outer diameter of at least 17F and a maximum outer diameter of 29F.
  • the transition section 13 in this embodiment does not adopt the braided structure in the first embodiment, but after a petal structure is formed, the wire 11 extending radially to the middle of the disc body 10 is directly bent to extend axially, and then extends axially to the position of another disc body 10, and then forms the petal structure of another disc body 10, so that a straight transition section 13 is formed, and the structure is simpler.
  • the transition section 13 can also adopt other forms such as spiral.
  • the double-layer structure of the disc body 10 of this embodiment is formed by overlapping petal structures.
  • the petal structures are still arranged along the circumference of the disc body 10, but the petal structures are not connected in sequence. Instead, at least a portion of the circumference of the petal structures is axially overlapped. That is to say, one petal structure is placed in one layer and the other petal structure is placed in another layer, and the two layers of petal structures overlap axially to form the entire disc body 10. At this time, the disc body 10 still forms a double-layer structure.
  • each thread 11 is relatively large, and its central angle is approximately 120°.
  • the petal structures formed by three threads 11 are located in one layer, and the other three petal structures are located in another layer.
  • the overlapping part between the two axially overlapping petal structures forms a gap 12 for the delivery sheath to pass through.
  • this embodiment evenly distributes the two layers of petal structures, that is, the two layers of petal structures are arranged at a circumferential interval of 60°, so that six gaps 12 are formed, each of which is of the same size and occupies a circumferential range of 60° of the disc body 10.
  • the difference from the first embodiment is that the structures of the two disk bodies 10 of this embodiment are different.
  • the structures of the two discs 10 are different, one of the discs 10 is a double-layer structure, which is basically the same as the structure of the disc 10 in the first embodiment, and the other disc 10 is a single-layer structure.
  • the patent foramen ovale occluder forms a structure in which the double-layer disc 10 and the single-layer disc 10 are matched.
  • the formation method of the single-layer disc 10 can refer to the structure of the double-layer disc 10, except that the wire 11 of the single-layer disc 10 does not need to extend axially, but only needs to extend in one plane.
  • both discs 10 can also be set to a single-layer structure.
  • the single-layer disc body 10 is the same as the double-layer disc body 10, and both are preferably single-layer disc bodies 10 with a depression between the center and the edge, and the center protrudes away from the distal end relative to the depression, thereby preventing warping.
  • the angle of the gap 12 formed by the double-layer structure disk 10 formed by eight silk threads 11 is 45°, while the angle of the gap 12 formed by the single-layer structure disk 10 formed by six silk threads 11 is 60°.
  • the two are axially stacked to form a maximum gap angle of 45°.
  • the delivery sheath tube cooperates with the maximum gap of 45° and can pass through it. The specific values are the same as those in Example 1 and will not be repeated here.
  • the petal structure of this embodiment forms two layers, there are still multiple petal structures in the same layer, and the two adjacent petal structures in the same layer are still connected in sequence along the circumference of the disc body 10.
  • the specific connection method can adopt the connection structure 30 in the aforementioned embodiment or the method of winding together, etc., which will not be repeated here.
  • the PFO overlap length was (9.1 ⁇ 4.7) mm
  • the secondary septum thickness was (6.0 ⁇ 1.2) mm.
  • the multiple in the above embodiments refers to at least two.
  • the delivery sheath can pass through the gap and thus through the disc, making it possible to puncture the atrial septum and deliver the sheath into the left atrium, thus retaining the opportunity for minimally invasive interventional treatment of atrial fibrillation, mitral regurgitation and other diseases;

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
  • Prostheses (AREA)

Abstract

本申请提供了一种卵圆孔未闭封堵器，包括：至少两个盘体，盘体之间一体设置并形成整体件，盘体包括多根丝线，各丝线回旋缠绕并共同形成具有至少一层结构且呈花朵状的盘体，丝线之间形成有间隙，间隙的大小大于等于预定的输送鞘管的大小，以使输送鞘管能够穿过间隙以穿过卵圆孔未闭封堵器；连接件，连接件位于盘体中心端部，连接件用于回收丝线，丝线的端部汇集在连接件处；阻流膜，阻流膜附着在盘体的外表面，并且遮挡间隙。本申请解决了现有技术中的患者进行PFO封堵术后无法再进行房间隔穿刺的问题。

Description

卵圆孔未闭封堵器
本申请要求于2022年11月30日提交至中国国家知识产权局、申请号为202211522091.6，发明名称为“卵圆孔未闭封堵器”的专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，具体而言，涉及一种卵圆孔未闭封堵器。
背景技术
卵圆孔未闭是常见的先天性心脏病，目前其主流的治疗方式是使用封堵器行经皮(股静脉)封堵术(即PFO封堵)。在该类手术中，封堵器是最重要的医疗器材之一。目前，常用的房缺封堵器和PFO封堵器均是由镍钛合金丝进行编织的密网结构，加上封堵器的面积较大，植入后患者想要再穿刺房间隔将鞘管送入左心房变成了不可能，使得患者丧失房间隔这一介入通道，也就丧失了微创介入治疗心房颤动、二尖瓣反流等疾病的机会。
发明内容
本申请的主要目的在于提供一种卵圆孔未闭封堵器，以解决现有技术中的患者进行PFO封堵术后无法再进行房间隔穿刺的问题。
为了实现上述目的，本申请提供了一种卵圆孔未闭封堵器，包括：至少两个盘体，盘体之间一体设置并形成整体件，盘体包括多根丝线，各丝线回旋缠绕并共同形成具有至少一层结构且呈花朵状的盘体，丝线之间形成有间隙，间隙的大小大于等于预定的输送鞘管的大小，以使输送鞘管能够穿过间隙以穿过卵圆孔未闭封堵器；连接件，连接件位于盘体中心端部，连接件用于回收丝线，丝线的端部汇集在连接件处；阻流膜，阻流膜附着在盘体的外表面，并且遮挡间隙。
在一个可选的实施例方式中，间隙形成有内切圆，内切圆的直径大于等于预定的输送鞘管的直径。
在一个可选的实施例方式中，盘体包括多个由丝线形成的花瓣结构，各花瓣结构沿盘体的周向依次对接设置，花瓣结构形成间隙。
在一个可选的实施例方式中，每根丝线形成至少一个花瓣结构，丝线由盘体的中部径向向外延伸预定距离后折弯并周向延伸，周向延伸预定距离后丝线折弯并径向延伸至盘体的中部，在丝线径向延伸和/或周向延伸的过程中丝线轴向延伸以形成双层结构。
在一个可选的实施例方式中，每个花瓣结构中径向延伸的两段丝线之间的区域作为间隙。
在一个可选的实施例方式中，盘体包括多个由丝线形成的花瓣结构，各花瓣结构沿盘体的周向设置，各花瓣结构之间周向的至少一部分轴向重叠设置，以形成双层结构。
在一个可选的实施例方式中，位于同一层且相邻的两个花瓣结构沿盘体的周向依次对接设置，并且轴向重叠的两个花瓣结构之间重叠的部分形成间隙。
在一个可选的实施例方式中，卵圆孔未闭封堵器还包括连接结构，周向对接的两个花瓣结构之间通过连接结构连接在一起。
在一个可选的实施例方式中，周向对接的两个花瓣结构上对接处的丝线之间缠绕在一起。
在一个可选的实施例方式中，每个盘体中的丝线数量为6-8根。
在一个可选的实施例方式中，盘体包括多个由丝线形成的花瓣结构，各盘体之间轴向相对设置，并且轴向相邻的两个盘体之间轴向对应的两个花瓣结构由同一根或者同几根丝线形成，轴向相邻的两个盘体之间由丝线形成螺旋形或者直线形或者编织型的过渡段。
在一个可选的实施例方式中，丝线为镍钛合金丝线。
在一个可选的实施例方式中，丝线的截面直径为0.20-0.40mm。
在一个可选的实施例方式中，盘体的中心与边缘处之间呈凹陷状，且中心相对于边缘处靠近远端，各盘体的凹陷方向相同。
在一个可选的实施例方式中，盘体具有至少两层结构。
在一个可选的实施例方式中，至少两个盘体中，至少一个盘体为单层结构，且为单层结构的盘体的中心与边缘处之间呈凹陷状。
应用本申请的技术方案，通过丝线盘绕形成花朵状的盘体，并且丝线之间并非是密布形成密网结构，而是将丝线之间间隔较大距离形成间隙，而且间隙的大小与输送鞘管的大小相适配，使得输送鞘管可以通过间隙，从而可以穿过盘体，实现穿刺房间隔将鞘管送入左心房的可能，保留了微创介入治疗心房颤动、二尖瓣反流等疾病的机会。同时盘体的结构能够保证卵圆孔未闭封堵器能够保证其固定效果，配合盘体表面设置的阻流膜能够实现卵圆孔未闭封堵器的封堵效果，起到阻止血液通过和加快内皮化进程的作用，而连接件的设置一方面能够将丝线的端部汇集起来，另一方面连接件还能够与外部的操作部件配合，实现操作卵圆孔未闭封堵器的作用。上述设置方式在保证卵圆孔未闭封堵器正常使用的前提下，使得卵圆孔未闭封堵器增加了可以供输送鞘管穿过的功能，保留了可穿房间隔的可能，为微创介入治疗 心房颤动、二尖瓣反流等疾病提供了机会，同时还具有降低器械上血栓的风险，快速内皮化，减少镍离子释放的功能。
附图说明
构成本申请的一部分的说明书附图用来提供对本申请的进一步理解，本申请的示意性实施例及其说明用于解释本申请，并不构成对本申请的不当限定。在附图中：
图1示出了本申请的实施例一的卵圆孔未闭封堵器的结构示意图；
图2示出了图1的主视图；
图3示出了本申请的实施例二的卵圆孔未闭封堵器的俯视图；
图4示出了本申请的实施例三的卵圆孔未闭封堵器的结构示意图；
图5示出了图4的主视图；
图6示出了图4的俯视图；
图7示出了本申请的实施例四的卵圆孔未闭封堵器的结构示意图；
图8示出了图7的主视图；
图9示出了图7的俯视图；
图10示出了本申请的实施例五的卵圆孔未闭封堵器的结构示意图；
图11示出了图10的主视图；
图12示出了图10的俯视图。
其中，上述附图包括以下附图标记：
10、盘体；11、丝线；12、间隙；13、过渡段；20、连接件；30、连接结构。
具体实施方式
需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将参考附图并结合实施例来详细说明本申请。
为了解决现有技术中的患者进行PFO封堵术后无法再进行房间隔穿刺的问题，本申请提供了一种卵圆孔未闭封堵器。
实施例一
如图1和图2所示的一种卵圆孔未闭封堵器，包括至少两个盘体10、连接件20和阻流膜，盘体10之间一体设置并形成整体件，盘体10包括多根丝线11，各丝线11回旋缠绕并共同形 成具有至少一层结构且呈花朵状的盘体10，丝线11之间形成有间隙12，间隙12的大小大于等于预定的输送鞘管的大小，以使输送鞘管能够穿过间隙12以穿过卵圆孔未闭封堵器；连接件20位于盘体10中心端部，连接件20用于回收丝线11，丝线11的端部汇集在连接件20处；阻流膜附着在盘体10的外表面，并且遮挡间隙12。
本实施例通过丝线11盘绕形成花朵状的盘体10，并且丝线11之间并非是密布形成密网结构，而是将丝线11之间间隔较大距离形成间隙12，而且间隙12的大小与输送鞘管的大小相适配，使得输送鞘管可以通过间隙12，从而可以穿过盘体10，实现穿刺房间隔将鞘管送入左心房的可能，保留了微创介入治疗心房颤动、二尖瓣反流等疾病的机会。同时盘体10的结构能够保证卵圆孔未闭封堵器能够保证其固定效果，配合盘体10表面设置的阻流膜能够实现卵圆孔未闭封堵器的封堵效果，起到阻止血液通过和加快内皮化进程的作用，而连接件20的设置一方面能够将丝线11的端部汇集起来，另一方面连接件20还能够与外部的操作部件配合，实现操作卵圆孔未闭封堵器的作用。上述设置方式在保证卵圆孔未闭封堵器正常使用的前提下，使得卵圆孔未闭封堵器增加了可以供输送鞘管穿过的功能，保留了可穿房间隔的可能，为微创介入治疗心房颤动、二尖瓣反流等疾病提供了机会，同时还具有降低器械上血栓的风险，快速内皮化，减少镍离子释放的功能。
本实施例以盘体10设置有两个为例，并且两个盘体10轴向相对设置，每个盘体10均形成双层结构，这样，卵圆孔未闭封堵器形成双盘双层式的结构形式。
在本实施例中，由于输送鞘管呈圆形，而间隙12的形状可能是各种各样的，因而，要保证输送鞘管能够穿过间隙12，只要保证间隙12形成的内切圆的直径大于等于预定的输送鞘管的直径即可使得二者相适配。
本实施例的盘体10整体呈花朵状，其主要包括多个花瓣结构，各花瓣结构周向设置形成花朵状，而花瓣结构则是由丝线11盘绕形成的，这样盘体10整体为框架结构，从而形成间隙12。本实施例的各花瓣结构沿盘体10的周向依次对接设置，相邻两个花瓣结构之间的边缘处丝线11对接在一起，从而形成盘体10，此时由于花瓣结构之间几乎没有缝隙，因而间隙12则由花瓣结构本身形成，也就是说框架式的花瓣结构自身中间的空间即为间隙12。
需要说明的是，每个花瓣结构的具体形状以及形成花朵状的具体形状均可以根据需要调整，不局限于本实施例所给出的结构形式。
可选地，花瓣结构的形成可以是一根丝线11形成的，也可以是多根丝线11形成的，同样地，每根丝线11可以形成一个花瓣结构，也可以形成多个花瓣结构。本实施例为了减少丝线11的用量采用的每根丝线11形成两个花瓣结构，并且两个花瓣结构为两个盘体10轴向相对的两个花瓣结构。
为了便于解释，首先以一个花瓣结构的形成为例。丝线11的一端与盘体10中部的连接件20连接，其由连接件20起始，沿盘体10的径向向外，即向远离盘体10中心的方向延伸预定距离，然后丝线11折弯并改变方向为沿盘体10的周向延伸，周向延伸预定距离后的丝线11再次折弯，并重新沿盘体10的径向向内，也就是向盘体10的中部延伸，直到延伸到盘体10 的中部，这样，一个花瓣结构即可形成。而在上述丝线11径向延伸和/或周向延伸的过程中，丝线11可以同时轴向延伸一段距离，这样，一根丝线11即可形成轴向两层的双层结构。按照上述过程，其他丝线11依次形成各自的花瓣结构，同一个盘体10上的花瓣结构依次周向排列，各花瓣结构径向延伸的丝线11节段之间对接在一起，从而形成整个盘体10。需要注意的是，由于丝线11形成花瓣结构的过程中有轴向两层的变化，因而在将各花瓣结构对接时，将位于轴向同一层的丝线11节段之间对接在一起，这样即可形成双层结构。而间隙12则为每个花瓣结构中径向延伸的两段丝线11之间的区域。
需要说明的是，上述的径向延伸、周向、轴向延伸并非是需要完全保证径向、周向和轴向，只要大体上沿径向、周向和轴向即可，可以有进一步的折弯处理，以形成所需要的形状，只要整体上是沿径向、周向和轴向即可。
本实施例的盘体10采用两层结构，当然，盘体10除了本实施例设置的两层结构外，也可以根据需要设置更多层。本实施例之所以将盘体10设置成双层结构，是考虑到卵圆孔未必在封堵时需要考虑继发隔和原发隔之间通道的长度，常见通道为倾斜的，即非正对着的，所以两个盘体10封堵时会错开一些位置，双层结构的不易翘边，且错位封堵时，仍能保持较好的封堵效果。
对于卵圆孔未闭封堵器整体而言，各盘体10之间轴向相对设置，并且将轴向相邻的两个盘体10之间轴向对应的两个花瓣结构由同一根或者同几根丝线11形成，本实施例采用由同一根丝线11形成的方式，具体而言，本实施例在轴向相邻的两个盘体10之间由丝线11形成具有螺旋的编织型的过渡段13，即上述的一个花瓣结构形成后，径向延伸至盘体10中部的丝线11绕设在两个盘体10之间的中部，并且形成编织型结构，该部分丝线11即为过渡段13，起到过渡连接两个盘体10使其形成整体件的作用。螺旋编织后的丝线11即延伸到另一个盘体10的位置处，而后重复之前花瓣结构的形成过程，先径向延伸，再周向延伸，最后径向延伸到盘体10的中心处，与其他丝线11缠绕回收在过渡段13处，这样，上下两个相对的花瓣结构即可形成，按此依次完成各丝线11的盘绕，从而形成上下两个盘体10，上下两个盘体10之间中部形成过渡段13，而盘体10中部设置的连接件20即可位于过渡段13的端部(附图1、2中并未示出过渡段13的具体结构，可以参照图4、5中的过渡段13，其是相同的)。
需要说明的是，基于上述的盘绕方式，本实施例相对设置的两个盘体10中，径向延伸的丝线11的相对关系以及靠近远离关系也是一致的，即相对的两个盘体10中，两个花瓣结构的丝线11的轴向延伸方向是相同的，其同时向盘体10的一侧方向延伸，这样，由一根丝线11形成的两个花瓣结构轴向基本相同排列，仅轴向延伸的具体距离不同，从而形成凹陷状。当然，具体设置方式不局限于本实施例上述的方式，也可以根据需要设置成其他的结构形式。
本实施例设置有八根丝线11，八根丝线11使得每个盘体10形成八个花瓣结构，每个花瓣结构占盘体10周向45°的范围，也就是近似扇形的间隙12的圆心角为45°，此时，卵圆孔未闭封堵器的直径规格从1818-3030，通过45°扇形计算最小间隙为31.8mm2，最大间隙为88.4mm2，其内切圆直径最大约为8.5mm，最小约为5.2mm，可通过至少外径为15F的输送鞘 管，最大可通过外径为25F输送鞘管。F代表周长，3F＝直径为1mm的输送鞘管所对应的周长，15F的输送鞘管即可通过直径为5mm的输送鞘管。
当然，丝线11的数量可以根据需要调整，每个盘体10中的丝线11数量为6-8根，其形成的绳状结构也为6-8股。当两个盘体10中相对的两个花瓣结构均是由一根丝线11形成时，每个盘体10中丝线11的数量即为卵圆孔未闭封堵器整体的丝线11数量。
优选地，本实施例的丝线11为镍钛合金丝线，并且单根丝线11的截面直径为0.20-0.40mm，这样，镍钛合金丝线加粗能够保证卵圆孔未闭封堵器的夹合力，避免因为丝线11的减少而导致夹合力降低的情况，保证卵圆孔未闭封堵器的正常使用。
本实施例的阻流膜采用高分子编织膜，高分子编织膜非常薄，房间隔穿刺针能轻易穿过。并且在双层内侧进行了ePTFE的覆膜工艺，通过对ePTFE的表面改性，即蚀刻，ePTFE表面的水滴角进行改变，使得原本稳定性较强的ePTFE具有良好的热熔性，彻底阻止右心房的血液流到左心房形成血栓，同时ePTFE具有很好的生物相容性。并且阻流膜的孔径优选为160±30μm，从而能够更好地促进内皮化的进程的同时房间隔穿刺针能轻易穿过。
本实施例的连接件20采用回收螺母，回收螺母设置有一个，其位于一个盘体10的中心处，而另一个盘体10的中部未设置有连接件20，其丝线11之间可以缠绕在一起，从而形成无铆结构。这样，卵圆孔未闭封堵器整体即形成单铆双层结构。
在本实施例中，盘体10的中心与边缘处之间呈凹陷状，且中心相对于边缘处而言靠近远端，也就是说中心向远端的方向突出，凹陷的开口侧背离远端(所谓远端在医疗领域即为远离操作者手部的一端)，同时各盘体10的凹陷方向相同。这样，有利于从输送鞘管中释放封堵器，不需要增大输送鞘管的尺寸。
实施例二
如图3所示，在本实施例中，相邻两个花瓣结构之间通过缠绕在一起的方式实现连接。具体而言，本实施例将相邻两个花瓣结构之间的径向延伸的两条丝线11，也就是周向对接的两个花瓣结构上对接处的丝线11之间交错缠绕的方式拧在一起，形成绳状结构(附图3中仅示出了部分丝线缠绕在一起)。这样，整体上可以不借助外部部件，自身即可实现各部分之间的牢固连接。
实施例三
与实施例一的区别在于，花瓣结构之间对接的方式不同。
如图4至图6所示，在本实施例中，卵圆孔未闭封堵器还包括连接结构30，连接结构30可以是缝合线、连接丝等结构，周向对接的两个花瓣结构的丝线11并没有缠绕在一起，而是直接近似平行设置，二者之间通过连接结构30连接在一起，从而形成整个盘体10。
同时，本实施例的回收螺母设置有两个，并且分别位于两个盘体10的中心处，从而可以与丝线11和外部部件配合，使得卵圆孔未闭封堵器均为双铆双层结构。
需要说明的是，实施例一中的相邻两个花瓣结构之间的丝线11可以采用实施例二中的方式缠绕形成绳状结构，也可以采用实施例三中的方式实现连接，优选实施例二中的方式。
实施例四
与实施例一的区别在于，丝线11的设置数量不同。
如图7至图9所示，本实施例的丝线11设置有六根，六根丝线11使得每个盘体10形成六个花瓣结构，每个花瓣结构占盘体10周向60°的范围，也就是近似扇形的间隙12的圆心角为60°，此时，卵圆孔未闭封堵器的直径规格从1818-3030，通过60°扇形计算最小间隙为42.39mm2，最大间隙为117.75mm2，其内切圆直径最大约为9.81mm，最小约为5.96mm，可通过至少外径为17F的输送鞘管，最大可通过外径为29F的输送鞘管。
同时，本实施例中的过渡段13并没有采用实施例一中的编织型的结构，而是一个花瓣结构形成后，径向延伸至盘体10中部的丝线11直接折弯改变至轴向延伸，轴向延伸至另一个盘体10的位置处，然后形成另一个盘体10的花瓣结构，这样形成直线形的过渡段13，结构更加简单。当然，过渡段13除了上述的直线形、编织型外，也可以采用螺旋形等其他形式。
实施例五
与实施例一的不同在于，本实施例的盘体10双层结构由花瓣结构之间叠置形成。
如图10至图12所示，在本实施例中，各花瓣结构依旧沿盘体10的周向设置，但是花瓣结构之间并非是依次对接的，而是将各花瓣结构之间周向的至少一部分轴向重叠设置，也就是说，将一个花瓣结构置于一层，另一个花瓣结构置于另一层，而且两层花瓣结构之间轴向重叠一部分，以此形成整个盘体10，此时盘体10依旧形成双层结构。
本实施例的丝线11也设置有六根，每根丝线11形成的花瓣结构的大小较大，其圆心角大致为120°，这样，三个丝线11形成的花瓣结构位于一层，另外三个花瓣结构位于另一层，此时，轴向重叠的两个花瓣结构之间重叠的部分形成供输送鞘管穿过的间隙12。为了保证间隙12的均匀性，本实施例将两层花瓣结构之间均布，即两层花瓣结构之间周向间隔60°设置，这样，形成六个间隙12，每个间隙12大小一致并且占盘体10周向60°的范围。
实施例六
与实施例一的不同在于，本实施例的两个盘体10的结构不同。
在本实施例中，两个盘体10的结构不同，其中一个盘体10为双层结构，其与实施例一中的盘体10的结构基本相同，而另一个盘体10为单层结构，这样，卵圆孔未闭封堵器形成双层的盘体10与单层的盘体10相配合的结构形式，单层盘体10的形成方式可以参照双层盘体10的结构，只是单层的盘体10的丝线11并不需要轴向延伸，只需要在一个平面内延伸即可。当然，也可以将两个盘体10均设置成单层结构等。
需要说明的是，单层的盘体10与双层的盘体10相同，均优选为单层结构的盘体10的中心与边缘处之间呈凹陷状，且中心相对于凹陷而言向背离远端的方向突出，从而可以起到防止翘边的效果。
对于本实施例单双层配合的结构形式，八根丝线11形成的双层结构的盘体10形成的间隙12的角度为45°，而六根丝线11形成的单层结构的盘体10形成的间隙12的角度为60°，二者轴向叠置，形成的最大间隙的角度为45°，输送鞘管与最大45°的间隙配合，能够穿过即可，具体数值与实施例一中相同，在此不再赘述。
虽然本实施例的花瓣结构形成两层，但是同一层依旧有多个花瓣结构，位于同一层且相邻的两个花瓣结构之间沿盘体10的周向依旧是依次对接设置，其具体连接方式可以采用前述实施例中的连接结构30或者缠绕在一起的方式等，在此不再赘述。
需要说明的是，上述实施例中的各种设置方式之间可以根据需要进行替换和组合，部分设置方式，例如过渡段13的设置方式、连接结构30与缠绕在一起的设置方式等均可以根据需要同时使用。
上述实施例中的夹合力试验数据：通过实验，在PFO模拟模型中得出以下数据，采用相同规格为1825(右房盘直径为25mm，左房盘直径为18mm)：
实验夹合力的原始数据为：
封堵前PFO重叠长度为(9.1±4.7)mm，继发隔厚度为(6.0±1.2)mm。
需要说明的是，上述实施例中的多个指的是至少两个。
从以上的描述中，可以看出，本申请上述的实施例实现了如下技术效果：
1、解决了现有技术中的患者进行PFO封堵术后无法再进行房间隔穿刺的问题；
2、输送鞘管可以通过间隙，从而可以穿过盘体，实现穿刺房间隔将鞘管送入左心房的可能，保留了微创介入治疗心房颤动、二尖瓣反流等疾病的机会；
3、还具有降低器械上血栓的风险，快速内皮化，减少镍离子释放的功能。
显然，上述所描述的实施例仅仅是本申请一部分的实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都应当属于本申请保护的范围。
以上所述仅为本申请的优选实施例而已，并不用于限制本申请，对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的保护范围之内。

Claims (16)

  1. 一种卵圆孔未闭封堵器，其特征在于，包括：
    至少两个盘体(10)，所述盘体(10)之间一体设置并形成整体件，所述盘体(10)包括多根丝线(11)，各所述丝线(11)回旋缠绕并共同形成具有至少一层结构且呈花朵状的所述盘体(10)，所述丝线(11)之间形成有间隙(12)，所述间隙(12)的大小大于等于预定的输送鞘管的大小，以使所述输送鞘管能够穿过所述间隙(12)以穿过所述卵圆孔未闭封堵器；
    连接件(20)，所述连接件(20)位于所述盘体(10)中心端部，所述连接件(20)用于回收所述丝线(11)，所述丝线(11)的端部汇集在所述连接件(20)处；
    阻流膜，所述阻流膜附着在所述盘体(10)的外表面，并且遮挡所述间隙(12)。
  2. 根据权利要求1所述的卵圆孔未闭封堵器，其特征在于，所述间隙(12)形成有内切圆，所述内切圆的直径大于等于预定的所述输送鞘管的直径。
  3. 根据权利要求1所述的卵圆孔未闭封堵器，其特征在于，所述盘体(10)包括多个由所述丝线(11)形成的花瓣结构，各所述花瓣结构沿所述盘体(10)的周向依次对接设置，所述花瓣结构形成所述间隙(12)。
  4. 根据权利要求3所述的卵圆孔未闭封堵器，其特征在于，每根所述丝线(11)形成至少一个所述花瓣结构，所述丝线(11)由所述盘体(10)的中部径向向外延伸预定距离后折弯并周向延伸，周向延伸预定距离后所述丝线(11)折弯并径向延伸至所述盘体(10)的中部，在所述丝线(11)径向延伸和/或周向延伸的过程中所述丝线(11)轴向延伸以形成双层结构。
  5. 根据权利要求4所述的卵圆孔未闭封堵器，其特征在于，每个所述花瓣结构中径向延伸的两段所述丝线(11)之间的区域作为所述间隙(12)。
  6. 根据权利要求1所述的卵圆孔未闭封堵器，其特征在于，所述盘体(10)包括多个由所述丝线(11)形成的花瓣结构，各所述花瓣结构沿所述盘体(10)的周向设置，各所述花瓣结构之间周向的至少一部分轴向重叠设置，以形成双层结构。
  7. 根据权利要求6所述的卵圆孔未闭封堵器，其特征在于，位于同一层且相邻的两个所述花瓣结构沿所述盘体(10)的周向依次对接设置，并且轴向重叠的两个所述花瓣结构之间重叠的部分形成所述间隙(12)。
  8. 根据权利要求3或7所述的卵圆孔未闭封堵器，其特征在于，
    所述卵圆孔未闭封堵器还包括连接结构(30)，周向对接的两个所述花瓣结构之间通过所述连接结构(30)连接在一起。
  9. 根据权利要求3或7所述的卵圆孔未闭封堵器，其特征在于，
    周向对接的两个所述花瓣结构上对接处的所述丝线(11)之间缠绕在一起。
  10. 根据权利要求1至7中任一项所述的卵圆孔未闭封堵器，其特征在于，每个所述盘体(10)中的丝线(11)数量为6-8根。
  11. 根据权利要求1所述的卵圆孔未闭封堵器，其特征在于，所述盘体(10)包括多个由所述丝线(11)形成的花瓣结构，各所述盘体(10)之间轴向相对设置，并且轴向相邻的两个所述盘体(10)之间轴向对应的两个所述花瓣结构由同一根或者同几根所述丝线(11)形成，轴向相邻的两个所述盘体(10)之间由所述丝线(11)形成螺旋形或者直线形或者编织型的过渡段(13)。
  12. 根据权利要求1至7中任一项所述的卵圆孔未闭封堵器，其特征在于，所述丝线(11)为镍钛合金丝线。
  13. 根据权利要求12所述的卵圆孔未闭封堵器，其特征在于，所述丝线(11)的截面直径为0.20-0.40mm。
  14. 根据权利要求1至7中任一项所述的卵圆孔未闭封堵器，其特征在于，所述盘体(10)的中心与边缘处之间呈凹陷状，且所述中心相对于所述边缘处靠近远端，各所述盘体(10)的凹陷方向相同。
  15. 根据权利要求1至7中任一项所述的卵圆孔未闭封堵器，其特征在于，所述盘体(10)具有至少两层结构。
  16. 根据权利要求1至7中任一项所述的卵圆孔未闭封堵器，其特征在于，至少两个所述盘体(10)中，至少一个所述盘体(10)为单层结构，且为单层结构的所述盘体(10)的中心与边缘处之间呈凹陷状。
PCT/CN2023/105252 2022-11-30 2023-06-30 卵圆孔未闭封堵器 WO2024113862A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202211522091.6A CN115715690A (zh) 2022-11-30 2022-11-30 卵圆孔未闭封堵器
CN202211522091.6 2022-11-30

Publications (1)

Publication Number Publication Date
WO2024113862A1 true WO2024113862A1 (zh) 2024-06-06

Family

ID=85257565

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2023/105252 WO2024113862A1 (zh) 2022-11-30 2023-06-30 卵圆孔未闭封堵器

Country Status (2)

Country Link
CN (1) CN115715690A (zh)
WO (1) WO2024113862A1 (zh)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115715690A (zh) * 2022-11-30 2023-02-28 广东脉搏医疗科技有限公司 卵圆孔未闭封堵器
CN116269547B (zh) * 2023-05-23 2023-08-15 杭州德诺电生理医疗科技有限公司 封堵装置与封堵系统
CN117257371B (zh) * 2023-09-05 2024-05-03 南京思脉德医疗科技有限公司 一种体内缝合用储线阀及缝合器

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090118745A1 (en) * 2007-11-06 2009-05-07 Cook Incorporated Patent foramen ovale closure apparatus and method
CN212650857U (zh) * 2020-07-24 2021-03-05 广东脉搏医疗科技有限公司 一种无铆型封堵器
CN214128635U (zh) * 2020-11-02 2021-09-07 上海形状记忆合金材料有限公司 一种无内膜密编卵圆孔未闭封堵器
WO2022091018A1 (en) * 2020-11-02 2022-05-05 Recross Cardio, Inc. Interseptal occluder device
CN115715690A (zh) * 2022-11-30 2023-02-28 广东脉搏医疗科技有限公司 卵圆孔未闭封堵器

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090118745A1 (en) * 2007-11-06 2009-05-07 Cook Incorporated Patent foramen ovale closure apparatus and method
CN212650857U (zh) * 2020-07-24 2021-03-05 广东脉搏医疗科技有限公司 一种无铆型封堵器
CN214128635U (zh) * 2020-11-02 2021-09-07 上海形状记忆合金材料有限公司 一种无内膜密编卵圆孔未闭封堵器
WO2022091018A1 (en) * 2020-11-02 2022-05-05 Recross Cardio, Inc. Interseptal occluder device
CN115715690A (zh) * 2022-11-30 2023-02-28 广东脉搏医疗科技有限公司 卵圆孔未闭封堵器

Also Published As

Publication number Publication date
CN115715690A (zh) 2023-02-28

Similar Documents

Publication Publication Date Title
WO2024113862A1 (zh) 卵圆孔未闭封堵器
US12035900B2 (en) Devices and methods for occluding abnormal openings in a patient's vasculature
US11512416B2 (en) Braided medical device and manufacturing method thereof
US20200367905A1 (en) Medical devices for treating a target site and associated method
JP6248351B2 (ja) 挟角可変の扁平ディスク面を有する閉鎖栓
US9775590B2 (en) Braided hemostasis shaft for improved torsional response
RU2446773C2 (ru) Многослойные плетеные конструкции для окклюзии сосудистых дефектов
EP1827310B1 (en) Filament-wound implantable devices
JP6006348B2 (ja) 経皮カテーテル給送式血管内閉塞器具
US8940015B2 (en) Asymmetrical medical devices for treating a target site and associated method
JP2022531433A (ja) 通過可能な隔壁閉塞デバイス
EP2449971A2 (en) Heart septal defect occlusion device
CN211583280U (zh) 包覆型封堵器
US10076401B2 (en) Vein filter
CN110680415B (zh) 包覆型封堵器
CN110507372A (zh) 一种可自适应的心脏封堵器
WO2024139219A1 (zh) 组织夹持装置及组织夹持系统

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23896025

Country of ref document: EP

Kind code of ref document: A1