CN2610872Y - Asymmetric ventricular septal defect plugging device - Google Patents

Asymmetric ventricular septal defect plugging device Download PDF

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Publication number
CN2610872Y
CN2610872Y CN 03229648 CN03229648U CN2610872Y CN 2610872 Y CN2610872 Y CN 2610872Y CN 03229648 CN03229648 CN 03229648 CN 03229648 U CN03229648 U CN 03229648U CN 2610872 Y CN2610872 Y CN 2610872Y
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occluder
disk
connected
blocker
disc
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CN 03229648
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Chinese (zh)
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秦永文
龚善石
许嘉龙
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龚善石
秦永文
许嘉龙
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Abstract

The utility model relates to an asymmetric ventricular septal defect blocker, the bracket (1) of which is waved out of nitinol alloy wire. The utility model includes essentially of a left ventricle disk of the blocker (2) and a right ventricle disk of the blocker (4) which stand opposite to each other, and a blocker waist (3) through which the left ventricle disk of the blocker (2) and the right ventricle disk of the blocker (4) are connected, wherein one end of the left ventricle disk of the blocker (2) is connected with a fixedly connecting means (7), and the other end of the blocker is provided with the right ventricle disk (4) which is connected to a fixedly connecting means (5), the fixedly connecting means (5) is provided with a connecting drill way (6) connected with a convey control system, and the left ventricle disk of the blocker (2) and the right ventricle disk of the blocker (4) form an asymmetric structure. The utility model has a proper elasticity, is convenient to be put in and easy to position, and has a reliable healing effect.

Description

一种非对称心室间隔缺损封堵器 A non-ventricular septal defect occluder of the Heart

技术领域 FIELD

本实用新型涉及一种植入人体器官内的医疗器械,具体涉及一种非对称心室间隔缺损封堵器。 The present invention relates to an implantable medical device within the body organs, particularly relates to a non Heart ventricular septal defect occluder.

背景技术 Background technique

先天性心脏病心室间隔缺损是一种常见的先天性心脏疾病,病变的特点是在左右心室之间的心室间隔未能正常闭合。 Congenital heart disease, ventricular septal defect is a common congenital heart disease characterized by lesions in the left heart ventricle septal between the failure to close properly. 由于正常情况下,左心室的压力高于右心室,引起左心室的血液部分经心室间隔缺损处分流至右心室,导致右心系统的负担增加,引起右心室肥大,肺循环血量增加,最终可引起肺动脉高压、心律失常和心衰。 Because under normal circumstances, pressure in the left ventricle than the right ventricle, the left ventricle causes blood fraction septal defect careful disposal stream to the right ventricle, which causes an increase of the right heart, causing right ventricular hypertrophy, pulmonary blood volume increase, eventually pulmonary hypertension, heart failure and cardiac arrhythmias. 以往对心室间隔缺损的传统治疗方法是外科手术缝合,而外科手术需要开胸,对病人创伤大,并发症发生率高,并留下手术切口疤痕。 Traditional treatment of ventricular septal defect conventional methods are surgical, surgical procedures require the chest, large trauma patients, high incidence of complications, and leave the surgical scar. 为了使先天性心脏病心室间隔缺损患者避免开胸手术,自1976年以来,国内外先后发明了多种封堵器材,如Rishkind、Sideris和Amplatzer等品牌的封堵器,探索应用经心导管送入封堵器闭合心室间隔缺损。 In order to ventricular septal defect with congenital heart disease patients to avoid open-chest surgery, since 1976, has invented a variety of domestic and plugging equipment, such as Rishkind, Sideris and other brands of Amplatzer occluders, exploring the application of Transcatheter delivery closing the ventricular septal defect occluder. 经过临床应用发现,Amplatzer封堵器封堵治疗肌部室缺的疗效较好,Rishkind、Sideris封堵器治疗膜部室缺的并发症发生率较高。 After clinical application discovery, Amplatzer occluder closure of muscular ventricular septal defect better treatment efficacy, Rishkind, Sideris occluder higher incidence of complications membranous ventricular septal defect. 但到目前为止,市场上尚未有治疗膜部心室间隔室缺的封堵器。 But so far, yet the treatment of membranous ventricular septal ventricular septal defect occluders on the market.

心室间隔缺损的类型是经导管治疗的重要决定因素。 Type ventricular septal defect is an important determinant of transcatheter treatment. 适于行经导管闭合的病变特点是心室间隔缺损至少距主动脉瓣2mm以上,心室间隔缺损直径大于3mm和小于10mm。 Passing the conduit adapted to close the ventricular septal defect is characterized by lesions of at least 2mm or more from the aortic valve, ventricular septal defect diameter greater than 3mm and less than 10mm. 心室间隔缺损大小不一,形态也不规则,需要封堵器有不同直径的型号,以适合不同大小的心室间隔缺损。 Ventricular septal defect sizes, shape is irregular, the need occluder models of different diameters to suit different sized ventricular septal defect. 心脏在不停的跳动,封堵器到位后应能可靠的固定在心室间隔缺损处。 Heart kept beating, after occluder in place should be able to secure a fixed heart septal defect. 封堵器能否可靠的固定,其决定因素是选用封堵器的大小和封堵器支架的弹力。 Can occluder reliable fixation, determining factor is the choice of the size and the force of the occluder occluder holder. 封堵器弹性大,弹力强,有利于固定,但弹性强度大不利于封堵器在导管内输送到心室间隔缺损处,如选择的大小型号不合适时也不利于撤出体外。 Occluder elastic, elastic, fixed beneficial, but is not conducive to the elastic strength occluder delivery within a catheter to a septal defect in the heart, is not conducive when such withdrawal vitro selection of sizes unsuitable. 因此要求封堵器的金属支架的强度合适。 Thus the strength requirements of the occluder suitable metal stent. 封堵器弹性强度主要取决于镍钛合金丝的粗细和经热处理后的超弹性特性。 Occluder elastic strength depends superelastic characteristics after thermally treated and the thickness of the nickel-titanium alloy wire. 由于心室间隔缺损患者多为儿童,血管较细,插入血管内的导入封堵器的输送鞘管不能大于股静脉的直径。 Since ventricular septal defect patients are children diameter, smaller vessels, occluder introducing the delivery sheath into the blood vessel within the tube can not be greater than the femoral vein. 因此,镍钛丝的粗细、超弹性与导管直径的选择是封堵器设计和制作的依据原则之一。 Thus, the thickness, the diameter of the catheter with a superelastic nickel-titanium wire is selected according to the principle one occluder design and production. 再次,封堵器表面应平整光滑,使之不易在其表面形成血栓。 Again, the surface should be smooth occluder that is less thrombogenic surface thereof. 因此封堵器表面在设计中应充分考虑表面的一体化处理。 Thus the occluder surface should be considered in the design surface of the integrated process.

发明内容 SUMMARY

本实用新型的的目的是提供一种结构合理、适于不同大小的膜部心室间隔缺损的封堵器。 Object of the present invention is to provide a reasonable structure, the film unit is adapted to different sizes of heart ventricular septal defect occluder.

为此,本实用新型提供了一种经导管闭合心室间隔缺损的封堵器。 To this end, the present invention provides a transcatheter closure of ventricular septal defect occluder. 该封堵器呈非对称的双盘形,封堵器盘片主要由超弹性金属丝编织而成,经心脏导管送入心脏缺损的部位,从导管内推出后自动恢复设计的形状,夹在缺损的心室间隔两侧,使缺损闭合,达到治愈的目的。 The occluder asymmetrical double disc-shaped occluder disk woven mainly from a superelastic metal wire, via a cardiac catheter into the heart defect site after the introduction of automatic recovery from catheter designed shape, sandwiched on both sides of the heart septal defect, so that defect closure, healing purposes.

本实用新型提供的一种非对称心室间隔缺损封堵器为由镍钛合金丝编织而成的支架,其主要包括相向而立的封堵器的左心室盘片及封堵器的右心室盘片,连接上述左心室盘片和封堵器的右心室盘片的封堵器的腰部,所述的封堵器的左心室盘片一端与固定连接部件相连,所述的封堵器另一端有所述的右心室盘片与固定连接部件相连,在所述的固定连接部件上有连接孔道可与输送控制系统相连接;其中,所述的封堵器的左心室盘片及封堵器的右心室盘片为非对称结构。 A non-present invention provides a ventricular septal defect occluder of the Heart by wire woven nitinol stent comprising a main stand facing the disk occluder left ventricle and right ventricle of the disk occluder , occluder disk connecting the right ventricle and the left ventricle disk occluder waist, left ventricular end of the disk occluder connected with the fixed member connected to the other end of the occluder the right ventricle is fixedly connected with the disc member connected to a connecting bore may be connected to the delivery control system on a fixed member connected to said; wherein said disc occluder and occluder left ventricle Right ventricular disc asymmetric structure.

本实用新型的优点及积极的效果:由于本实用新型采纳了以往封堵器的优点,根据室间隔缺损的形态及其周围的的结构,制作成不规则的圆盘状,在主动脉瓣侧的边缘较短,可避免封堵器置入后对主动脉瓣膜的损伤。 And advantages of the present invention a positive effect: since the advantages of the present invention adopts a conventional occluder, ventricular septal defect in accordance with the morphology and structure surrounding a disk made into an irregular shape, the aortic side shorter edge, to avoid damage to the aortic valve into the occluder. 本实用新型在左右心室侧的不锈钢圈的长度较短,有利于封堵器植入后上皮化的形成,从而减少可能产生血栓形成的并发症。 The present invention is stainless steel ring length in shorter side of the left and right ventricles, facilitate epithelization occluder implantation is formed, thereby reducing the possible complications of thrombosis. 在所述的固定装置上有连接孔道可与输送控制系统相连接,这样,使得对于封堵器的控制更加方便,灵活。 Connecting bore may be connected to the delivery control system, so that the control is more convenient for the occluder, the flexible fixing means. 另外,封堵器是经特殊编织技术编织而成,受力牵拉后可成线条状,能通过6~7F的鞘管送入心室间隔缺损处,对穿刺点和血管损伤均较轻。 Further, occluder woven together by special weaving technique, may be pulled by the force into a linear shape, through the sheath 6 ~ 7F fed ventricular septal defect, and for the puncture point are mild vascular injury. 即仅需要在外表切开皮肤2~3mm,即可完成心室间隔缺损的修补手术。 That is only necessary to cut the outer skin 2 ~ 3mm, to complete the surgical repair of ventricular septal defect.

下面,结合附图与实施例对本实用新型作进一步的说明。 Hereinafter, in conjunction with further embodiments of the present invention as described drawings.

附图说明 BRIEF DESCRIPTION

图1为本实用新型提供的封堵器左心室面结构示意图。 Figure 1 is a schematic view of the occluder of the left ventricle of the invention provides surface structure.

图2为本实用新型提供的封堵器支架的立体结构示意图。 FIG 2 is a perspective schematic view of the structure of the invention provides occluder holder.

图3为图2中A部局部放大示意图。 FIG. 2 FIG. 3 is a partially enlarged view of portion A.

图4为本实用新型提供的封堵器右心室面结构示意图。 FIG 4 is a schematic view of the surface structure of the right ventricle invention provides occluder.

图5为现有封堵器传输连接部件的拉脱力测试图。 FIG 5 is a conventional pull-transmitting connecting member occluder de Tests FIG.

图6为本实用新型传输连接部分的拉脱力测试图。 FIG 6 the present invention connected to a transmission part pull-off Test FIG.

具体实施方案如附图1-3所示,本实用新型实施例提供的一种非对称心室间隔缺损封堵器为由镍钛合金丝编织而成的支架1,其主要包括相向而立的封堵器的左心室盘片2及封堵器的右心室盘片4,连接上述左心室盘片2和封堵器的右心室盘片4的封堵器的腰部3,所述的封堵器的左心室盘片2一端与固定连接部件7相连,所述的封堵器另一端有所述的右心室盘片4与固定连接部件5相连,在所述的固定连接部件5上有连接孔道6可与输送控制系统相连接;其中,所述的封堵器的左心室盘片2及封堵器的右心室盘片4为非对称结构。 As a particular embodiment shown in Figures 1-3, a non-embodiment the present invention provides a ventricular septal defect occluder of the Heart by Nitinol wire braided stent 1, which mainly comprises opposing standing block 2 and the left ventricle disk occluder's right ventricle of the disk 4, the disk 2 and connecting the left ventricle and right ventricle occluder disk occluder 4 waist 3, the occluder disk 2 is connected to the left ventricular end member 7 is fixedly connected with said other end of the occluder 4 is connected to the right ventricle disk member 5 is fixedly connected, on the connecting member 5 is fixedly connected channel 6 may be connected to the delivery control system; wherein the right ventricle of the disk 2 and the disk occluder left ventricle of the occluder 4 is an asymmetric structure.

本实用新型由镍钛合金丝在模具上按一定的路线编织成平底袋状,两端应用316L不锈钢圈固定,放入特制的内外模具之间,经热处理后形成非对称的双盘状,并控制处理温度,达到需要的超弹性和记忆功能。 The present invention is a nickel-titanium alloy wire according to a certain line on the mold flat woven into a bag shape, both ends of the fixed ring application 316L stainless steel, interposed between the inner and outer dies specially formed asymmetrical discoid bis after heat treatment, and the temperature control process, and to achieve the desired super elastic memory.

本实用新型提供的一种封堵器的右心室盘片4一端的固定连接控制部件5与左心室盘片2一端的固定连接部件7都应用医用不锈钢圈固定控制,所述的不锈钢圈5的侧向端有连接孔道6可与输送控制系统相连接,上述的右心室一端的固定连接控制部件5与左心室盘片2一端的固定连接部件7都内端中空,可与上述的镍钛合金丝相连,所述的螺丝与镍钛丝之间应无焊点,而是采用捏合技术制成,其拉力大大强于目前已有的通过焊接而成的支架,且不易脱落;如图5、图6所示,现有的封堵器的控制端采用焊接技术,当通过最大拉脱力60牛顿时,延长2.6毫米,而本实用新型提供的封堵器控制端当最大拉脱力为200牛顿时,延伸1.2毫米,可见,本实用新型采用无焊点的拉脱力明显高于现有的用焊接的封堵器。 Right ventricle disk 4 fixedly connected at one end of an occluder according to the present invention provides a control member 5 and the left ventricular end member fixedly connected to the disk 2 are fixed to control application of medical stainless steel ring 7, the stainless steel ring 5 lateral end connecting bore 6 may be connected to the delivery control system, the control member fixedly connected to the above-described right ventricular and left ventricular end 5 of one end of the disc 2 are fixedly connected to the inner end of the hollow member 7, with the above nickel-titanium alloy wire connected between the screws should be no nickel titanium wire solder, but made kneading technology, in which there are much stronger force by welded brackets, and easy to fall off; in FIG. 5, FIG. 6, the control terminal of the occluder conventional welding technology, when the maximum pull-off force of 60 Newtons, the extension of 2.6 mm, and the present invention provides a control terminal of the occluder when the maximum pull-off force of 200 Newtons, the extending 1.2 mm, can be seen, the present invention uses pull-off force without welds significantly higher than conventional welding occluder.

本实用新型提供的一种非对称心室间隔缺损封堵器的支架内衬入3-10层聚酯膜,应用医用缝线将聚酯膜与支架部分缝合在一起,放入透吸纸消毒袋中经环氧乙烷灭菌后备用。 The present invention provides a non Heart of ventricular septal defect occluder holder 3-10 liner layer into the polyester film, the polyester film applied with the medical suture portion of the suture holder together into sterilization bags permeable absorbent paper after the backup by ethylene oxide sterilization.

手术时,将封堵器与推送杆相连接,拉入短鞘内,经短鞘送入长鞘管内,通过推送杆经输送鞘管将封堵器推送至左心室处,左心室的盘片出鞘管后靠自身的超弹性张开,回拉至室缺孔处,超声显示封堵器的左心室面位于左心室侧,如有阻力,则固定推送杆,回撤鞘管,释放出右心室盘片,两侧的盘片通过自身的超弹性,夹在心室间隔缺损的两侧,如推送和回拉时封堵器位置固定,则可释放出封堵器,结束手术。 Surgery, the occluder connected with the push rod relative to pull-in short intrathecal, a short length of the sheath into the sheath, by pushing the rod through the delivery sheath to be pushed to the left ventricle at the occluder, the left ventricle disk after the sheath pipe by its own superelastic open, pull back to the hole ventricular septal defect, ventricular ultrasound display surface side of the occluder is located in the left ventricle, if the resistance is fixed to the push rod sheath retracement released disk platter right ventricle, both through its own superelastic sandwiched on both sides of the heart septal defects, such as push and pull back when the occluder fixed position, they can release the occluder, the end of surgery.

本实用新型提供的镍钛合金丝是封堵器支架;聚酯纤维膜衬入中间,起到阻挡血流的作用;固定连接部分的作用是固定镍钛金丝和提供与输送控制系统相连接。 The present invention provides a nitinol wire stent is occluders; polyester film liner into the intermediate, plays the role of blocking the blood flow; role of fixing the connection portion is fixed to the nickel titanium wire, and providing a transmission control system connected . 所述的封堵器的外形呈非对称的双盘状,连接两圆盘的腰部呈圆柱形,圆盘比腰部直径大,左心室侧的盘片在主动脉瓣侧边缘与圆柱部分相等,其对侧比圆柱部分大6mm,右心室侧的盘片边缘比圆柱直径大4mm,为对应型分布。 The shape of the occluder double asymmetrical discoid, connected cylindrical waist two discs, the disc is larger than the diameter of the waist, the disc is equal to the ventricular side of the aortic valve in the cylindrical portion side edges, its opposite side, the disc-side edge of the right ventricle of the large cylindrical portion is larger than the ratio of cylinder diameter 6mm 4mm, corresponding type distribution. 右心室侧向有固定的不锈钢圈。 The right lateral ventricle of a fixed stainless steel ring. 应用时将钢丝绳穿过封堵器的侧孔中与输送部分连接,封堵器到位后牵拉钢丝绳的一端,释放出封堵器。 Wire rope passing through the application-side end of the occluder hole is connected to the delivery portion, the pulling rope of the occluder in place, release of the occluder. 封堵器有良好的形状记忆功能,受到外力牵引呈线条状,外力去除后立即恢复原始形状。 Occluder good shape memory, by an external force pulling shaped lines, to restore the original shape immediately after the force is removed.

在临床应用中,根据超声和术中造影测量的心室间隔缺损直径选择封堵器的大小。 In clinical application, the ultrasonic measurements and intraoperative angiography choose the size of the diameter of ventricular septal defect occluder. 通常选择封堵器的直径大约1~2mm。 Generally selected occluder diameter of about 1 ~ 2mm. 封堵器经输送鞘管送入左心室,在左心室内首先打开左心室面及封堵器的腰部,回撤鞘管,释放出右心面的盘片。 Occluder through the delivery sheath into the left ventricle, the left ventricle first surface and a waist opening occluder within the left ventricle, retracement of the sheath to release the right heart side of the disk. 在超声和X光线引导下确定封堵器植入的位置和封堵效果。 Determining occluder implanted under X ray and ultrasound guided location and plugging effect.

实施例1膜部心室间隔缺损的直径5mm,其边缘距主动脉瓣2mm。 Example 1 film diameter portion ventricular septal defect embodiment 5mm, the edges from the aortic valve 2mm. 选用腰部直径6mm的心室间隔缺损封堵器。 Selection 6mm diameter of the waist ventricular septal defect occluder. 封堵器的左心室面盘片直径为12mm,靠近主动脉侧的盘片边缘为0.5mm,右心室面盘片直径为10mm,心尖侧盘片边缘为5.5mm。 Left ventricular surface of the disk occluder diameter of 12mm, the aorta close to the disc edge side is 0.5mm, the disk surface right ventricular diameter of 10mm, the disk side apex edges 5.5mm. 封堵器高度为2mm。 Occluder height of 2mm.

实施例2心室间隔缺损的直径8mm,其边缘距主动脉瓣2mm以上。 Example 2 ventricular septal defect diameter of 8mm, which is more than 2mm from the edge of the aortic valve. 选用腰部直径10mm的心室间隔缺损封堵器。 Selection of 10mm diameter of the waist ventricular septal defect occluder. 封堵器的左心室面盘片直径为16mm,靠近主动脉侧的盘片边缘为0.5mm,右心室面盘片直径为14mm,心尖侧盘片边缘为5.5mm。 Left ventricular surface of the disk occluder diameter of 16mm, the aorta close to the disc edge side is 0.5mm, the disk surface right ventricular diameter 14mm, disc apical side edges 5.5mm. 封堵器高度为2mm。 Occluder height of 2mm.

Claims (3)

  1. 1.一种非对称室间隔缺损封堵器,其特征在于该封堵器由镍钛合金丝编织而成的支架(1),主要包括相向而立的封堵器的左心室盘片(2)及封堵器的右心室盘片(4),连接上述左心室盘片(2)和封堵器的右心室盘片(4)的封堵器的腰部(3),所述的封堵器的左心室盘片(2)一端与固定连接部件(7)相连,所述的封堵器另一端有所述的右心室盘片(4)与固定连接部件(5)相连,在所述的固定连接部件(5)上有连接孔道(6)可与输送控制系统相连接;其中,所述的封堵器的左心室盘片(2)及封堵器的右心室盘片(4)为非对称结构。 1. An asymmetric septal defect occluder, characterized in that the occluder knitted nitinol wire stent made of (1), including standing facing the left ventricle of the disk occluder (2) right ventricle and the disk occluder (4), the right ventricle disc (4) connecting the left ventricle of the disk (2) of the occluder and the occluder waist (3), the occluder LV disc (2) connected to one end attached to the fixed member (7), the other end of the occluder right ventricular disc (4) is fixedly connected to the member (5) is connected, in the connecting channel (6) can be connected to the transmission control system connected to a fixed member (5); wherein said disc occluder left ventricle (2) and the disk occluder in the right ventricle (4) asymmetric structure.
  2. 2.根据权利要求1所述的一种非对称室间隔缺损封堵器,其特征在于所述的固定连接部件(5)、固定连接部件(7)均采用医用不锈钢圈固定控制,螺丝与镍钛丝之间无焊点,采用捏合技术制成。 2. A method according asymmetric septal defect occluder according to claim 1, characterized in that the fixed connection member (5), fixing the connecting member (7) are made of medical stainless steel fixed control ring, screw nickel no welding between titanium wire, use is made of the kneading technique.
  3. 3.根据权利要求1所述的一种非对称室间隔缺损封堵器,其特征在于所述的封堵器的外形呈非对称的双盘状,连接两圆盘的腰部(3)呈圆柱形,圆盘比腰部直径大,左心室侧的盘片(2)在主动脉瓣侧边缘与圆柱部分相等,其对侧比圆柱部分大6mm,右心室侧的盘片(4)边缘比圆柱直径大4mm,为对应型分布。 3. (3) according to claim 1 has a cylindrical An asymmetric septal defect occluder, wherein said occluder shape asymmetrical double disc-shaped, two discs connected to the waist of claim shaped, the disc is larger than the diameter of the waist, the left ventricle side disc (2) is equal to the cylindrical portion of the side edges of the aortic valve, the contralateral than 6mm large cylindrical portion, the right ventricular side of the disk (4) than the cylindrical edge diameter of 4mm, a corresponding type distribution.
CN 03229648 2003-03-21 2003-03-21 Asymmetric ventricular septal defect plugging device CN2610872Y (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101172048B (en) 2007-09-07 2011-05-18 邢泉生 Transthoracic minimally invasive heart ventricular septal defect plugging device conveying system
CN101431946B (en) 2006-04-27 2012-10-03 沃克拉心血管有限公司 Occluder
CN102895046A (en) * 2012-09-17 2013-01-30 邢泉生 Plugging device for a subconal or double-artery-valve subarterial ventricular septal defect
CN104159524A (en) * 2011-08-12 2014-11-19 W.L.戈尔及同仁股份有限公司 Heart occlusion devices

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101431946B (en) 2006-04-27 2012-10-03 沃克拉心血管有限公司 Occluder
CN101172048B (en) 2007-09-07 2011-05-18 邢泉生 Transthoracic minimally invasive heart ventricular septal defect plugging device conveying system
CN104159524A (en) * 2011-08-12 2014-11-19 W.L.戈尔及同仁股份有限公司 Heart occlusion devices
CN102895046A (en) * 2012-09-17 2013-01-30 邢泉生 Plugging device for a subconal or double-artery-valve subarterial ventricular septal defect
CN102895046B (en) * 2012-09-17 2016-04-06 邢泉生 A dry or di-lower aortic ventricular septal defect occluder

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