CN2613248Y - Ventricular septel defect block device - Google Patents

Ventricular septel defect block device Download PDF

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Publication number
CN2613248Y
CN2613248Y CN 03229649 CN03229649U CN2613248Y CN 2613248 Y CN2613248 Y CN 2613248Y CN 03229649 CN03229649 CN 03229649 CN 03229649 U CN03229649 U CN 03229649U CN 2613248 Y CN2613248 Y CN 2613248Y
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China
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occluder
ventricular
disk
platter
septal defect
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CN 03229649
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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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Publication of CN2613248Y publication Critical patent/CN2613248Y/en

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Abstract

The utility model discloses a heart separating defect occlusion device, which is a bracket (1) knitted by nitinol alloy wire, mainly comprising faced and standing left ventricular platter (2) of the occlusion device and the right ventricular platter (4) of the occlusion device, a waist portion (3) of the occlusion device which connects the left ventricular platter (2) of the occlusion device and the right ventricular platter (4), and a fixing connection part (5) one end of the occlusion device connected with the mentioned right ventricular platter (4), wherein the fixing connection part (5) is equipped with a connection hole passage (6) which can be connected with a transmission controlling system, the left ventricular platter (2) of the occlusion device and the right ventricular platter (4) of the occlusion device are asymmetric structure, and the left ventricular platter (2) of the occlusion device mentioned by the utility model is a flat round disc. The utility model has stable structure and reasonable shape, and increases the safety of occluding the ventricular separating defect through a pipe.

Description

一种心脏室间隔缺损封堵器 One cardiac ventricular septal defect occluder

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,具体涉及一种心脏室间隔缺损封堵器。 The present invention relates to an implantable medical device within the body organs, particularly the heart, to a 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,市场上未有治疗膜部心室间隔室缺的封堵器。 But so far, no treatment of membranous ventricular septal ventricular septal defect occluders on the market.

心脏室间隔缺损的类型是经导管治疗的重要决定因素。 Type of cardiac 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3mm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 more than 3mm 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

本实用新型的目的是提供一种结构合理、表面平滑的适于不同大小的膜部室间隔缺损封堵器。 The object of the present invention is to provide a reasonable structure, the surface smoothness of the film portion adapted to different sized 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. 该封堵器呈对称的双盘形状,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 double-disc occluder symmetrical shape, the disk occluder 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 defect heart septal sides of the defect closure, healing purposes.

本实用新型提供的一种心脏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,连接上述封堵器的左心室盘片和封堵器的右心室盘片的封堵器的腰部,以及位于封堵器一端与所述的右心室盘片相连的固定连接部件5,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对称结构,所述的封堵器的左心室盘片为平整的圆盘。 The present invention provides a ventricular septal defect occluder by cardiac Nitinol wire braided stent, which includes the right ventricle standing facing the disk occluder and the occluder left ventricle of the disk, Right ventricular occluder disk connecting the occluder and occluder disk left ventricle waist, and one end of the occluder is located in the right ventricle fixing the connecting member 5 is connected to the disk, the have the channels connecting member may be fixedly connected to the delivery control system is connected; wherein the right ventricle and the disk occluder disk left ventricle of the occluder to be symmetrical, the left occluder ventricular flat disk of a disk.

手术时,将封堵器通过钢丝绳与推送杆相连接,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 by wire ropes pushers, short pull intrathecal, a short length of the sheath into the sheath, the occluder delivery sheath pushed by pushers at the left ventricle through the left ventricle on its own disk superelastic expanded after sheath tube, to pull back 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, releasing the disk platter right ventricle, both through its own superelastic, sandwiched on both sides of the septal defect, such as when the push and pull back position fixing occluder, the occluder may be released, the end of surgery.

由于本实用新型采纳了以往封堵器的优点,采用独特的编织技术制作左心室侧的圆盘,使其平整,避免了目前在临床上应用的Amplatzer肌部心室间隔缺损封堵器在左心室侧使用固定螺丝引起的左心室侧盘片不平整。 Since the present invention adopts the advantages of a conventional occluder, a unique technology to produce the left ventricle side knitting disk, it flat, to avoid Amplatzer muscular ventricular currently in clinical applications in ventricular septal defect occluder side fixing screws ventricular side of the disk due to unevenness. 本实用新型在左心室侧全部由镍钛合金丝编织,表面光整,有利于封堵器植入后上皮化形成,减少因左心室面不光整而可能产生血栓形成的并发症。 The present invention is in the left ventricle side knitting all of nitinol wire, the whole surface of the light, is formed in favor epithelialization after occluder implantation, reducing not only the whole surface of the left ventricle due to complications that may arise thrombus formation. 封堵器的左心室盘片的边缘部分长度不均,在主动脉瓣侧的边缘较短,而在心尖侧的边缘较长,可减少主动脉返流的发生率和增加稳定性。 Left ventricular portion of the length of the edge of the disk occluder unevenness, in a short-side edge of the aortic valve, and the apex at the edge of the longer side, can reduce the incidence of aortic regurgitation and increase stability. 本实用新型在右心室侧采用一种新型的固定装置,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;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,并且,可使封堵器右心室侧的固定装置更加小巧,植入后有助于上皮化形成,减少因右心室面不光整而可能产生血栓形成的并发症。 In the present invention, a novel use of the right ventricular side of the fixing device, use is made of the kneading technique, in which there are much stronger force by welded brackets, and easy to fall off; connecting means on said fixing conveying channels can be connected to the control system, so that the control is more convenient for the occluder, flexible, and the right ventricular side of the fixing device can occluder more compact, after formation of the implant facilitate epithelization, reducing because only the whole surface of the right ventricle of complications that may arise thrombus formation. 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.

具体实施方式 Detailed ways

如附图1-4所示,本实用新型实施例提供的一种心脏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,连接上述封堵器的左心室盘片2和封堵器的右心室盘片4的封堵器的腰部3,以及位于封堵器一端与所述的右心室盘片4相连的固定连接部件5,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为对称结构,所述的封堵器的左心室盘片2为平整的圆盘。 As shown in figures 1-4, one cardiac septal embodiment of the present invention to provide a defect occluder by Nitinol wire braided stent 1, which mainly comprises standing facing the left ventricle of the occluder 4 the disk platter right ventricle, the right ventricle of the disk occluder connecting the occluder disk 2 and the left ventricle 4 of the occluder and occluder waist 32, and one end of the occluder is located the right ventricle is fixedly connected to the disc 4 is connected to member 5, connecting channel 6 may be connected to the transmission control system is connected on the fixing member 5; left disc wherein said occluder 2 and right ventricular occluder disk 4 to be symmetrical, the left ventricle of the occluder disk 2 is a flat disc.

本实用新型由一根镍钛合金丝在模具上按一定的路线编织成平底袋状,一端应用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 consists of a nickel-titanium alloy wire according to a certain line on the mold flat woven into a bag shape, 316L stainless steel ring fixed to an end of the application, interposed between the inner and outer molds a special, a symmetrical bis discoid 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侧一端的固定连接控制部件5应用医用不锈钢圈固定控制,所述的不锈钢圈的侧向端有连接孔道6可与输送控制系统相连接,其内端中空,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。 Application of the control member 5 is fixedly connected to the medical end side of the stainless steel ring occluder one kind of the right ventricle of the present invention provides a fixed control, the lateral end of the stainless steel ring connecting bore 6 may be connected to the delivery control system, which the inner end of the hollow, may be coupled to said nitinol wire, should no welding between the screw and the nickel titanium wire, instead of using the kneading technology are made, which tensile force much stronger than currently available welded by stent, and easy to fall off; in FIG. 5, FIG. 6, the control terminal of the conventional welding techniques occluder, when the maximum pull-off force of 60 Newtons, extended 2.6 mm, while the present invention provides a closure when the control terminal when the maximum pull-off force of 200 Newtons, 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新型室间隔缺损封堵器的支架1内衬入3-5层聚酯膜,应用医用缝线将聚酯膜与支架部分缝合在一起,放入专用的消毒袋中经环氧乙烷灭菌后备用。 The present invention provides a new type ventricular septal defect occluder holder 1 into the liner polyester film layer 3-5, the polyester film applied with the medical suture portion of the suture holder together into sterilization bags dedicated after backup ethylene oxide sterilization.

手术时,将封堵器的固定连接部件通过钢丝绳与推送杆相连接,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 member fixedly connected to the wire rope is connected via a push rod, the 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 of the occluder after the left ventricle of the disk by its own sheath tube superelastic open, pull back to the hole ventricular septal defect, ventricular occluder ultrasound display surface side of the left ventricle is located, if the resistance, the fixed pushers, back withdrawal of the sheath to release the right ventricle disk, both sides of the disc by its own superelastic, sandwiched on both sides of the septal defect, such as a fixed position while pushing the occluder and pull-back, they can release the occluder the end of surgery.

本实用新型室间隔缺损封堵器是由超弹性镍钛合金丝、聚酯纤维膜和固定连接部分构成。 The present invention is a ventricular septal defect, polyester film, and fixing the connection portion formed of a superelastic nickel-titanium alloy wire. 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。 Occluder is Nitinol wire stent; 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. 封堵器的外形呈对称的双盘状,连接两圆盘的腰部略小于两侧,呈圆柱形,两侧圆盘比腰部直径大约4mm左右。 Occluder bis discoid shape was symmetrical, connecting the two sides of the disc is slightly smaller than the waist, cylindrical shape, both sides of the disc than the waist diameter of about about 4mm. 封堵器的左心室侧呈平整的圆盘,右心室侧有固定的钢圈。 Left ventricular side occluder flat disk shape, right ventricular side of the fixing rims.

应用时,通过钢丝绳与推送杆两者连接,到位后通过牵拉钢丝绳的一端,两者分离。 Application, by both the rope and the push rod is connected, at one end in place by pulling the rope, the two separated. 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.

在临床应中,根据超声和术中造影测量的室间隔缺损直径选择封堵器的大小,通常选择封堵器的直径大1~2mm。 In clinical application, the selected defect occluder size diameter of intraoperative angiography and ultrasonic measurement septum, typically selected occluder diameter of 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。 Example 1.

膜部室间隔缺损的直径5mm,其边缘距主动脉瓣3mm以上。 Membranous VSD diameter of 5mm, from the edge of the aortic valve which is above 3mm. 选用腰部直径6mm的室间隔缺损封堵器。 Selection of 6mm diameter of the waist ventricular septal defect occluder. 封堵器的左心室面盘片直径为10mm,右心室面盘片直径为10mm。 LV surface occluder disk having a diameter of 10mm, a diameter of the disk surface right ventricular 10mm. 封堵器高度为2mm。 Occluder height of 2mm.

实施例2。 Example 2.

室间隔缺损的直径8mm,其边缘距主动脉瓣4mm以上。 VSD diameter of 8mm, which is 4mm or more from the edge of the aortic valve. 选用腰部直径10mm的室间隔缺损封堵器。 Selection of 10mm diameter of the waist ventricular septal defect occluder. 封堵器的左心室面盘片直径为14mm,右心室面盘片直径为14mm。 Left ventricular surface of the disk occluder diameter of 14mm, a diameter of the disk surface right ventricular 14mm. 高度为2mm。 Height of 2mm.

Claims (5)

1.一种心脏室间隔缺损封堵器,其特征在于该封堵器由一根具有记忆性金属合金丝编织而成,主要包括:超弹性镍钛合金丝的支架(1),衬入上述封堵器的支架(1)中间的聚酯纤维膜阻隔层和一个固定在上述封堵器的支架(1)一端的固定连接部件(5)。 A cardiac ventricular septal defect, characterized in that the occluder consists of a memory metal alloy wire having a woven, including: a stent superelastic nitinol wire (1), into said substrate occluder holder (1) the intermediate polyester barrier layer and a fiber membranes fixed to the occluder holder (1) fixing one end of the connecting member (5).
2.根据权利要求1所述的一种心脏室间隔缺损封堵器,其特征在于所述的封堵器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),连接上述封堵器的左心室盘片(2)和封堵器的右心室盘片(4)的封堵器的腰部(3),以及位于封堵器一端与所述的右心室盘片(4)相连的固定连接部件(5),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。 According to claim 1. A cardiac ventricular septal defect occluder claim, wherein said occluder includes a right (2) and the occluder standing facing the left ventricle of the disk occluder ventricular disc (4), connecting the left ventricle of the disk occluder disk right ventricle (2) and a waist closure device (4) of the closure device (3), and one end of the occluder is located Right ventricular disc (4) fixing the connecting member (5) connected to be described later, the connection opening (6) can be connected to the transmission control system is connected on the fixing member (5).
3.、根据权利要求1或2所述的一种心脏室间隔缺损封堵器,其特征在于所述的封堵器的左心室盘片(2)及封堵器的右心室盘片(4)为对称结构,所述的封堵器的左心室盘片(2)为平整的圆盘。 3. A member according to claim 1 or claim cardiac septal defect occluder in claim 2, characterized in that the right ventricular ventricular disk platter (2) of the occluder and occluder (4 ) to be symmetrical, the left ventricle of the disk occluder (2) is a flat disc.
4.根据权利要求1或2所述的一种心脏室间隔缺损封堵器,其特征在于所述的固定连接部件(5)采用医用不锈钢圈固定控制,所述的固定钢圈与镍钛丝之间应无焊点,采用捏合技术制成。 According to claim 12 or one cardiac septal defect occluder, wherein said connector fixing member (5) made of medical stainless steel fixed control ring, said steel ring fixed to claim nickel titanium wire It should be no welding between, use is made of the kneading technique.
5.根据权利要求1或2所述的一种心脏室间隔缺损封堵器,其特征在于所述的封堵器的外形呈对称的双盘状,连接两圆盘的腰部略小于两侧,呈圆柱形,两侧圆盘比腰部直径大约4mm左右。 According to claim 12 or one cardiac septal defect occluder claim, wherein the outer shape of the occluder symmetrical double disc-shaped, connecting the two sides of the disc is slightly less than the waist, cylindrical shape, both sides of the disc than the waist diameter of about about 4mm.
CN 03229649 2003-03-21 2003-03-21 Ventricular septel defect block device CN2613248Y (en)

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