CN107260234B - Braided degradable occluder - Google Patents
Braided degradable occluder Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- 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
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- 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
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Abstract
本发明公开了一种编织可降解封堵器,包括丝材编织网以及分别设于丝材编织网两端的远端端头和近端端头,其特征在于,所述的丝材编织网内设有连接结构,连接结构的上端与远端端头连接,连接结构的下端连接近端端头或近端端头周围丝材编织网。本发明的编织可降解封堵器完全可降解,对病人远期效果更优,避免远期其他疾病诱发的封堵器并发症;切割管分几根勾合,使封堵器形态保持为“工”字型,封堵器与缺损贴合更好,保证封堵器在缺损的稳定性和封堵性;辅助线设计可以起到保险作用,当封堵器脱落时可以用辅助线回收,避免严重并发症。
The invention discloses a braided degradable occluder, comprising a wire braided mesh and a distal end and a proximal end respectively arranged at both ends of the wire braided mesh. A connection structure is provided, the upper end of the connection structure is connected with the distal end, and the lower end of the connection structure is connected with the proximal end or the wire braided mesh around the proximal end. The braided degradable occluder of the present invention is completely degradable, has better long-term effect on patients, and avoids complications of the occluder caused by other diseases in the long-term; "I" shape, the occluder fits better with the defect, ensuring the stability and occlusion of the occluder in the defect; the auxiliary line design can play an insurance role, when the occluder falls off, the auxiliary line can be used to recover, Avoid serious complications.
Description
技术领域technical field
本发明涉及一种编织可降解封堵器,属于医疗器械技术领域。The invention relates to a braided degradable occluder, belonging to the technical field of medical devices.
背景技术Background technique
现常有封堵器为镍钛形状记忆合金制得的蘑菇伞形状,在临床上得到广泛应用。但其存在潜在风险如下:Existing occluders are often in the shape of mushroom umbrellas made of nickel-titanium shape memory alloys, which are widely used in clinical practice. But its potential risks are as follows:
1、封堵器长期植入在心脏中,如果周边血管发生膨出病变,封堵器可能会磨损周围组织,产生诸如动脉夹层破裂等其他疾病;1. The occluder is implanted in the heart for a long time. If the peripheral blood vessels bulge, the occluder may wear the surrounding tissue and cause other diseases such as arterial dissection rupture;
2、随着病人发育成长,部分患者有一定概率发生远期三度传导阻滞;2. With the development and growth of patients, some patients have a certain probability of developing long-term third-degree conduction block;
3、少数病人术后才发现Ni离子过敏,对封堵器不耐承受,会造成其他问题;3. A small number of patients were found to be allergic to Ni ions after surgery, and they were intolerable to the occluder, which would cause other problems;
发明内容SUMMARY OF THE INVENTION
本发明要解决的技术问题是:提供了一种稳定性和封堵性好、避免严重并发症的编织可降解封堵器,解决了现常有的封堵器会磨损周围组织,使得患者发生远期三度传导阻滞,对封堵器不耐承受的问题。The technical problem to be solved by the present invention is: to provide a braided degradable occluder with good stability and occlusion performance, avoiding serious complications, and solving the problem that the existing occluder will wear the surrounding tissue and cause the patient to Long-term third-degree conduction block, the problem of intolerance to the occluder.
为了解决上述技术问题,本发明的技术方案是提供了一种编织可降解封堵器,包括丝材编织网以及分别设于丝材编织网两端的远端端头和近端端头,其特征在于,所述的丝材编织网内设有连接结构,连接结构的上端与远端端头连接,连接结构的下端连接近端端头或近端端头周围丝材编织网。In order to solve the above technical problems, the technical solution of the present invention is to provide a braided degradable occluder, which includes a wire braided mesh and a distal end and a proximal end respectively disposed at both ends of the wire braided mesh. The wire braided net is provided with a connection structure, the upper end of the connection structure is connected to the distal end, and the lower end of the connection structure is connected to the proximal end or the wire braided mesh around the proximal end.
优选地,所述的连接结构包括至少2根连接杆,每根连接杆均穿过丝材编织网的网格间隙与近端端头或近端端头周围丝材编织网连接。Preferably, the connecting structure includes at least two connecting rods, and each connecting rod is connected to the proximal end or the wire braided mesh around the proximal end through the mesh gap of the wire braided mesh.
优选地,所述的连接结构包括2-6根连接杆。Preferably, the connecting structure includes 2-6 connecting rods.
优选地,所述的连接结构为切割管材或弯曲丝材;切割管材的上端与远端端头连接,切割管材的下端设有均匀分劈的连接杆;弯曲丝材包括连接杆。Preferably, the connecting structure is a cutting pipe or a curved wire; the upper end of the cutting pipe is connected to the distal end, and the lower end of the cutting pipe is provided with a connecting rod that is evenly divided; the curved wire includes a connecting rod.
优选地,当每根所述的连接杆与近端端头连接,每根连接杆均向连接结构的轴向方向收拢。Preferably, when each of the connecting rods is connected to the proximal end, each connecting rod is retracted toward the axial direction of the connecting structure.
优选地,当每根所述的连接杆均与近端端头周围丝材编织网连接,每根连接杆的头端设有一个或两个弯勾。Preferably, when each of the connecting rods is connected with the wire braided mesh around the proximal end, the head end of each connecting rod is provided with one or two hooks.
优选地,当每根所述的连接杆的头端设有一个弯勾,每根连接杆均向连接结构的轴向方向收拢。Preferably, when the head end of each connecting rod is provided with a hook, each connecting rod is folded toward the axial direction of the connecting structure.
优选地,所述的远端端头上设有结扎套,所述的丝材编织网包括盘面和与盘面连接的腰部。Preferably, the distal end is provided with a ligation sleeve, and the wire braided mesh includes a disk surface and a waist connected to the disk surface.
优选地,所述的连接结构的材料为可降解材料或金属材料。Preferably, the material of the connecting structure is degradable material or metal material.
优选地,所述的可降解材料为聚乳酸、聚对二氧环己酮、PLGA;金属材料为镍钛合金、钴铬合金。Preferably, the degradable material is polylactic acid, polydioxanone, PLGA; the metal material is nickel-titanium alloy, cobalt-chromium alloy.
本发明的编织可降解封堵器完全可降解,对病人远期效果更优,避免远期其他疾病诱发的封堵器并发症;切割管分几根勾合,使封堵器形态保持为“工”字型,封堵器与缺损贴合更好,保证封堵器在缺损的稳定性和封堵性;辅助线设计可以起到保险作用,当封堵器脱落时可以用辅助线回收,避免严重并发症。The braided degradable occluder of the present invention is completely degradable, has better long-term effect on patients, and avoids complications of the occluder caused by other diseases in the long-term; "I" shape, the occluder fits better with the defect, ensuring the stability and occlusion of the occluder in the defect; the auxiliary line design can play an insurance role, when the occluder falls off, the auxiliary line can be used to recover, Avoid serious complications.
附图说明Description of drawings
图1为连接结构为切割管材时一种编织可降解封堵器的结构示意图(1);Fig. 1 is a structural schematic diagram (1) of a braided degradable occluder when the connection structure is a pipe cutting;
图2为连接结构为切割管材时一种编织可降解封堵器的结构示意图(2);Fig. 2 is a schematic structural diagram (2) of a braided degradable occluder when the connection structure is a pipe cutting;
图3为连接结构为切割管材时一种编织可降解封堵器的结构示意图(3);Fig. 3 is a structural schematic diagram (3) of a braided degradable occluder when the connection structure is a pipe cutting;
图4为一种编织可降解封堵器的俯视图;Figure 4 is a top view of a braided degradable occluder;
图5为一种编织可降解封堵器的释放过程示意图Figure 5 is a schematic diagram of the release process of a braided degradable occluder
a.一种编织可降解封堵器释放前的示意图;a. A schematic diagram of a braided degradable occluder before release;
b.一种编织可降解封堵器释放后的示意图;b. A schematic diagram of a braided degradable occluder after release;
图6为连接结构为弯曲丝材时一种编织可降解封堵器的结构示意图6 is a schematic structural diagram of a braided degradable occluder when the connecting structure is a curved wire
a.弯曲丝材的下端设有两个弯勾时一种编织可降解封堵器的结构示意图;a. A schematic structural diagram of a braided degradable occluder when the lower end of the curved wire is provided with two hooks;
b.弯曲丝材的下端设有一个弯勾时一种编织可降解封堵器的结构示意图;b. A schematic structural diagram of a braided degradable occluder when the lower end of the curved wire is provided with a hook;
c.弯曲丝材向其轴向方向收拢时一种编织可降解封堵器的结构示意图。c. A schematic structural diagram of a braided degradable occluder when the curved wire is folded in its axial direction.
具体实施方式Detailed ways
为使本发明更明显易懂,兹以优选实施例,并配合附图作详细说明如下。In order to make the present invention more obvious and comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings.
实施例1Example 1
因可降解丝材力学性能例如超弹性远弱于形状记忆合金丝材,为保证临床应用中封堵器起到封堵的预期效果,需要在结构上对封堵器进行一定补偿,补偿方案如图1-图3所示,在封堵器上端,即本发明的编织可降解封堵器远端丝材编织网2内增加一切割管材(即连接结构3),切割管材的上端与远端端头1固定连接。Because the mechanical properties of degradable wire, such as superelasticity, are much weaker than that of shape memory alloy wire, in order to ensure that the occluder can achieve the expected effect of occlusion in clinical applications, it is necessary to compensate the occluder in structure. As shown in FIGS. 1-3 , a cutting tube (ie, connecting structure 3 ) is added to the upper end of the occluder, that is, the wire braided mesh 2 at the distal end of the braided degradable occluder of the present invention, and the upper end and the distal end of the cutting tube are Terminal 1 is fixedly connected.
切割管材的下端端头均匀分劈成4根连接杆3-1,如图4所示,每根连接杆3-1都向切割管材的轴向方向收拢,如图1所示,当封堵器释放后,此切割管材在辅助线的回拉辅助下,切割管材下端每根连接杆3-1都穿过丝材编织网2的网格间隙,并向轴线方向收拢,卡紧封堵器的近端端头4,使得封堵器两端头直线距离与切割管材长度一致,此时封堵器稳定为“工”字型,保证封堵器不脱落,同时盘面2-1与腰部2-2都起到封堵的效果,实现力学上补充的效果。The lower end of the cutting pipe is evenly divided into 4 connecting rods 3-1, as shown in Figure 4, each connecting rod 3-1 is folded in the axial direction of the cutting pipe, as shown in Figure 1, when the plug is blocked After the release of the device, with the help of the auxiliary wire, each connecting rod 3-1 at the lower end of the cutting tube passes through the mesh gap of the wire braided mesh 2, and is closed in the direction of the axis to clamp the occluder. The proximal end 4 of the occluder is placed so that the straight line distance between the two ends of the occluder is consistent with the length of the cut pipe. At this time, the occluder is stabilized in the "I" shape to ensure that the occluder does not fall off. -2 both have the effect of blocking and achieve the effect of mechanical supplementation.
切割管材的材料可以是可降解材料,该可降解材料为聚乳酸、聚对二氧环己酮,PLGA等;切割管材的材料也可以是金属材料,该金属材料为镍钛合金、钴铬合金。The material for cutting the pipe can be a degradable material, and the degradable material is polylactic acid, polydioxanone, PLGA, etc.; the material for cutting the pipe can also be a metal material, and the metal material is nickel-titanium alloy, cobalt-chromium alloy .
如图5中a、b所示,两对称小腔中通过细微鞘管穿过封堵器网格,保证辅助线不缠绕在一起。辅助线穿过封堵器的丝材编织网2的网格并在封堵器远端端头绕过。操作时,辅助线一端在封堵器端,一端在鞘管接头端,当封堵器在缺损位置释放结束后,术者在鞘管接头端拉紧辅助线,辅助线带动封堵器远端端头1的结扎套1-1和切割管材向回行走,而“工”字型封堵器“工”字平台在辅助线拉扯情况下形成“酒杯”状,保证封堵器不脱落,同时盘面2-1与腰部2-2都起到封堵的效果,实现力学补偿效果,从而实现与镍钛形状记忆合金相同的封堵效果。当切割管材卡合位置固定良好后,在鞘管接头处将辅助线剪断,拉住一个断头,将辅助线拉扯出封堵器,最终随鞘管一同撤出。As shown in a and b in Figure 5, the occluder grid is passed through the fine sheath in the two symmetrical small cavities to ensure that the auxiliary wires are not entangled together. The auxiliary thread is passed through the mesh of the wire braided mesh 2 of the occluder and bypassed at the distal end of the occluder. During operation, one end of the auxiliary wire is at the end of the occluder, and the other end is at the end of the sheath tube. The ligation sleeve 1-1 of the end 1 and the cutting pipe travel back, and the "I"-shaped platform of the "I"-shaped occluder forms a "wine glass" shape when the auxiliary line is pulled to ensure that the occluder does not fall off, and at the same time Both the disk surface 2-1 and the waist 2-2 have the effect of blocking, realizing the mechanical compensation effect, so as to achieve the same blocking effect as the NiTi shape memory alloy. When the clamping position of the cutting tube is well fixed, cut the auxiliary wire at the joint of the sheath tube, pull a broken end, pull the auxiliary wire out of the occluder, and finally withdraw it together with the sheath tube.
实施例2Example 2
如图2所示,切割管材的下端端头均匀分劈成4根连接杆3-1,每根连接杆3-1都向切割管材轴向方向收拢,并在切割管材上的每根连接杆3-1的头端带有一弯勾3-2,当封堵器释放后,此切割管材在辅助线的回拉辅助下,切割管材下端每根连接杆3-1都穿过封堵器的丝材编织网2的网格间隙,并向轴线方向收拢,同时弯勾3-2勾紧封堵器近端端头4或近端端头4附近丝材编织网2的丝材/网格,使得封堵器两端头直线距离与切割管材长度一致,此时封堵器稳定为“工”字型,保证封堵器不脱落,同时盘面2-1与腰部2-2都起到封堵的效果,实现力学上补充的效果。As shown in Figure 2, the lower end of the cutting pipe is evenly divided into four connecting rods 3-1, each connecting rod 3-1 is folded in the axial direction of the cutting pipe, and each connecting rod on the cutting pipe is The head end of 3-1 is provided with a hook 3-2. When the occluder is released, the cutting pipe is assisted by the pullback of the auxiliary line, and each connecting rod 3-1 at the lower end of the cutting pipe passes through the occluder. The mesh gap of the wire braided mesh 2 is closed in the direction of the axis, and at the same time, the hook 3-2 is hooked to the proximal end 4 of the occluder or the wire/grid of the wire mesh 2 near the proximal end 4 , so that the straight line distance between the two ends of the occluder is consistent with the length of the cut pipe. At this time, the occluder is stable in the "I" shape to ensure that the occluder does not fall off. The effect of blocking is realized, and the effect of mechanical supplementation is realized.
其他与实施例1相同。Others are the same as in Example 1.
实施例3Example 3
如图3所示,切割管材的下端端头均匀分劈成4根连接杆3-1,每根连接杆3-1也可以不向切割管材轴向方向收拢,其在头端带有一个或两个弯勾3-2,当封堵器释放后,此切割管材在辅助线的回拉辅助下,切割管材的下端每根连接杆3-1都穿过封堵器的丝材编织网2的网格间隙,弯勾3-2勾紧封堵器近端端头4或近端端头4附近丝材编织网2的丝材/网格,使得封堵器两端头直线距离与切割管材长度一致,此时封堵器稳定为“工”字型,保证封堵器不脱落,同时盘面2-1与腰部2-2都起到封堵的效果,实现力学上补充的效果。As shown in Figure 3, the lower end of the cutting pipe is evenly split into four connecting rods 3-1, and each connecting rod 3-1 may not be folded in the axial direction of the cutting pipe. Two hooks 3-2, when the occluder is released, the cutting pipe is assisted by the pullback of the auxiliary line, and each connecting rod 3-1 at the lower end of the cutting pipe passes through the wire braided mesh 2 of the occluder The mesh gap of the occluder 3-2 is tightly hooked to the proximal end 4 of the occluder or the wire/mesh of the wire woven mesh 2 near the proximal end 4, so that the straight line distance between the two ends of the occluder is the same as the cutting distance. The length of the pipe is the same. At this time, the occluder is stable in the "I" shape to ensure that the occluder does not fall off. At the same time, both the disk surface 2-1 and the waist 2-2 have the effect of blocking, achieving the effect of mechanical supplementation.
其他与实施例1相同。Others are the same as in Example 1.
实施例4Example 4
如图6中a、b、c所示,封堵器连接切割管材也可以替换弯曲丝材(即连接结构3为弯曲丝材),弯曲丝材的头端弯曲,也可以实现勾合稳定的预期目的。As shown in a, b, and c in Figure 6, the occluder can also replace the curved wire with the cutting pipe (that is, the connecting structure 3 is a curved wire). intended purpose.
其他与实施例1相同。Others are the same as in Example 1.
实施例5Example 5
本实施例中,切割管材可以分为2根连接杆3-1。In this embodiment, the cutting pipe can be divided into two connecting rods 3-1.
其他与实施例1相同。Others are the same as in Example 1.
实施例6Example 6
本实施例中,切割管材可以分为6根连接杆3-1。In this embodiment, the cutting pipe can be divided into six connecting rods 3-1.
其他与实施例1相同。Others are the same as in Example 1.
Claims (7)
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108451570A (en) * | 2018-02-23 | 2018-08-28 | 上海形状记忆合金材料有限公司 | Assist molding device and method in Wholly-degradable plugging device body |
| CN110742658B (en) * | 2019-10-29 | 2022-09-23 | 中国医学科学院生物医学工程研究所 | Bilateral anisotropic absorbable occluder |
| CN114642467B (en) * | 2020-12-17 | 2024-12-31 | 先健科技(深圳)有限公司 | Occluder and occlusion system |
| CN115153678A (en) * | 2022-06-23 | 2022-10-11 | 上海傲流医疗科技有限公司 | Valve clearance shutoff filler and filling mechanism |
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| CN204181679U (en) * | 2014-10-13 | 2015-03-04 | 陈奕龙 | Occluder for left auricle |
| CN204971378U (en) * | 2015-08-12 | 2016-01-20 | 上海形状记忆合金材料有限公司 | Plugging device that can degrade completely in vivo |
| CN106344100A (en) * | 2016-10-11 | 2017-01-25 | 北京工业大学 | Left auricle plugging device |
| CN208065211U (en) * | 2017-06-16 | 2018-11-09 | 上海形状记忆合金材料有限公司 | A kind of degradable plugging device of braiding |
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| WO2006102213A1 (en) * | 2005-03-18 | 2006-09-28 | Nmt Medical, Inc. | Catch member for pfo occluder |
| US9005242B2 (en) * | 2007-04-05 | 2015-04-14 | W.L. Gore & Associates, Inc. | Septal closure device with centering mechanism |
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| CN204520803U (en) * | 2015-02-25 | 2015-08-05 | 上海形状记忆合金材料有限公司 | Split-type degradable stopper |
| CN105193521B (en) * | 2015-11-09 | 2018-06-12 | 柏为(武汉)医疗科技有限公司 | A kind of retrievable vena cava filter with good adherence quality |
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| CN204181679U (en) * | 2014-10-13 | 2015-03-04 | 陈奕龙 | Occluder for left auricle |
| CN204971378U (en) * | 2015-08-12 | 2016-01-20 | 上海形状记忆合金材料有限公司 | Plugging device that can degrade completely in vivo |
| CN106344100A (en) * | 2016-10-11 | 2017-01-25 | 北京工业大学 | Left auricle plugging device |
| CN208065211U (en) * | 2017-06-16 | 2018-11-09 | 上海形状记忆合金材料有限公司 | A kind of degradable plugging device of braiding |
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