CN104352260B - Left atrial appendage occlusion system - Google Patents

Left atrial appendage occlusion system Download PDF

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CN104352260B
CN104352260B CN 201410537620 CN201410537620A CN104352260B CN 104352260 B CN104352260 B CN 104352260B CN 201410537620 CN201410537620 CN 201410537620 CN 201410537620 A CN201410537620 A CN 201410537620A CN 104352260 B CN104352260 B CN 104352260B
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CN 201410537620
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CN104352260A (en )
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陈奕龙
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深圳市科奕顿生物医疗科技有限公司
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Abstract

本发明公开了一种左心耳封堵系统,包括封堵盘和锚定盘,所述的封堵盘采用镍钛合金丝编织,经热处理成形成盘状结构,所述的锚定盘也采用镍钛合金丝编织,经热处理成形成柱状结构,所述锚定盘至少包括一根粗丝,该粗丝由多根所述镍钛合金丝密绕而成,在所述锚定盘处于适当位置时,其中至少一根所述镍钛合金丝从所述锚定盘中向斜外方向伸出,作为锚刺,指向所述封堵盘,另外一根镍钛丝还作为编织网中的一根丝存在,起到连接上下两个钢套的作用。 The present invention discloses a left atrial appendage occlusion system, comprising a blocking plate and anchor plate, said disc occluder using nitinol wire braid is heat treated to form a disk-like structure, said anchor discs are also nitinol wire braid is heat treated to form a columnar structure, said anchor plate including at least one thick wire, a thick wire which a plurality of said nitinol wire tightly wound together, the anchor plate is properly position, wherein the at least one of said nitinol wire direction obliquely extending from the outer anchor plate, as the anchor thorn, the occluder disk point, an additional nickel-titanium wire in the braid as further one wire is present, acts as the upper and lower connecting steel sleeve. 本发明是一种闭塞左心耳,阻断左心耳内血栓流出效果佳,可重复定位,固定稳定的,耐疲劳的左心耳封堵系统。 The present invention is an occluding a left atrial appendage, left atrial thrombus block the outflow good effect, repeatable positioning, fixing stability, fatigue resistance of left atrial appendage occlusion system.

Description

左心耳封堵系统 Left atrial appendage occlusion system

技术领域 FIELD

[0001] 本发明涉及一种闭塞左心耳,阻断左心耳内血栓流出效果佳,可重复定位,固定稳定的,耐疲劳的左心耳封堵系统。 [0001] The present invention relates to an occluding a left atrial appendage, left atrial thrombus block the outflow good effect, repeatable positioning, fixing stability, fatigue resistance of left atrial appendage occlusion system.

背景技术 Background technique

[0002] 目前,随着介入器械的发展,许多外科手术无法治疗的治病得到了医治。 [0002] Now, with the development of interventional devices, surgical procedures can not cure many treatment was healed. 这些治病的治疗相对于外科手术的治疗方法,介入治疗法的创伤小,恢复快,疗效佳。 These curative treatment with respect to the method of treatment of surgery, less invasive method of intervention, quick recovery, good effect. 经过将近半个世纪的发展,介入治疗法得到了迅猛的发展,也产生了各种各样的介入医疗器械产品。 After nearly half a century of development, interventional therapy has been rapid development, but also produces a wide range of interventional medical devices. 使得越来越多的治病和患者得到治疗。 Making more and more patients to get medical treatment and therapy.

[0003] 心房颤动(房颤)是最常见的心律失常之一,除了心悸症状带来的不适,血栓栓塞等并发症的发生是房颤最主要的危害。 [0003] Atrial fibrillation (AF) is the most common arrhythmia, in addition to discomfort caused by the symptoms of heart palpitations, and other thromboembolic complications of atrial fibrillation is the main hazard. 非瓣膜性和非风湿性房颤患者中,约90%的血栓源自左心耳。 And non-valvular atrial fibrillation with non-rheumatic patients, about 90% of the thrombi from the left atrial appendage. 每年约有5%房颤患者发生血栓栓塞事件和脑卒中。 Each year, about 5% of patients with atrial fibrillation occurrence of thromboembolic events and stroke. 而脑卒中引起的致死率高达50%。 Stroke and death rate caused by up to 50%. 因此,如何预防和治疗房颤血栓引起的脑卒中具有重要的临床意义。 Therefore, it has important clinical significance of how to prevent and treat stroke caused by atrial thrombus. 目前预防和治疗房颤血栓的方法有外科手术、药物治疗和介入治疗方法。 Current methods for the prevention and treatment of thrombosis have atrial fibrillation surgery, drug therapy and interventional treatment. 其中外科手术法闭塞左心耳,由于其创伤大、风险高等原因未得到广泛的应用。 In which surgical occlusion of the left atrial appendage law, Because of its trauma, the reasons for higher risk has not been widely used. 目前,房颤病人预防脑中风的方法有的最普遍的方法是长期口服抗凝血药物,但抗凝血药物有导致出血的风险,约有14%〜44%的患者因存在禁忌证而无法接受长期药物抗凝治疗。 Currently, patients with atrial fibrillation stroke prevention methods and some of the most common approach is long-term oral anticoagulant medication, but anti-clotting drugs has led to the risk of bleeding, about 14% ~44% of patients due to the presence of contraindications and can not receiving long-term anticoagulation drugs. 近年来国内外发展了一种最先进的介入治疗法,通过细小的导管将特制的左心耳封堵器植入到左心耳内,闭塞左心耳,预防和治疗房颤患者发生血栓事件和脑卒中。 At home and abroad in recent years developed one of the most advanced interventional therapy through tiny tubes implanted a special LAA occluder into the left atrial appendage, left atrial appendage occlusion, prevention and treatment of thromboembolic events in patients with atrial fibrillation and stroke . 这种治疗方法创伤小,风险低,恢复快,疗效佳,从而成为预防和治疗房颤引起的脑卒中首选的治疗方法。 This treatment is less invasive, low risk, quick recovery, good curative effect, thus becoming the preferred method of treatment of stroke prevention and treatment of atrial fibrillation caused.

[0004]目前该类器械从结构来看,可大体分为编织型,切割型和混合型。 [0004] Such devices present the structure, can be divided into woven, cut and mixed. 这些类型的左心耳封堵器都可以通过导管介入的方法将封堵器送入左心耳内,实现左心耳闭塞。 These types can be left atrial appendage occluder catheter intervention by the methods of the occluder into the left atrial appendage, LAA occlusion achieved. 但是都存在相当的局限性。 However, there are considerable limitations. 每个人的左心耳解剖结构复杂,形状各异,有椭圆状,花生状等等。 Left atrial anatomy each complex shapes, oval-shaped, like peanut shape. 左心耳内壁凹凸不平,形状不规则,左心耳壁薄。 The inner wall of the left atrial appendage uneven, irregularly shaped, thin wall left atrial appendage. 所以难以在既不刺穿心壁,又能稳固锚定在左心耳内不脱落,最终达到理想的封堵效果。 It is difficult to pierce the heart wall is neither, but not falling firmly anchored in the left atrial appendage, and ultimately achieve the desired sealing effect.

[0005] 如发明专利CN200610037789和CN200580002183所设计的编织型左心耳封堵器。 [0005] The invention patent CN200610037789 CN200580002183 designed and woven left atrial appendage occluder. 他们利用封堵器的固定盘表面的凹凸不平的结构来锚定封堵器,封堵盘在左心耳口封堵,达到闭塞的效果。 The uneven structure they use a fixed occluder disk surface to anchor the occluder, the occluder disk occluder opening the left atrial appendage, to achieve the effect of the occlusion. 这种结构的设计优势在于结构简单,加工难度小,成本低。 Design advantage of this structure is simple structure, small processing difficulty and low cost. 但是编织的固定盘的锚定力度较低,很难适应形状各异的左心耳形态。 But the lower the intensity of braided anchor fixed disk, it is difficult to adapt to the left atrial appendage forms and shapes. 即使在固定盘上缝合锚定钩,在固定盘受到挤压变形的情况下依然很难刺入左心耳壁中,实现稳定固定。 Even if the fixed disk suture anchor hooks, the case where the fixing plate is pressed deformation still difficult piercing left atrial wall, to achieve stable fixation. 而且固定盘在左心耳内受到挤压变形后会影响封堵盘的形状,导致封堵效果不佳。 And after fixing plate by extrusion will affect the shape of the occluder plate in the left atrial appendage, resulting in poor sealing effect.

[0006] 如发明专利CN2〇0410〇59976和CN99S15453所涉及的切割型左心耳封堵器。 [0006] The patent invention relates CN99S15453 CN2〇0410〇59976 and cutting type left atrial appendage occluder. 他们将镍钛金属管切割,热处理成型成所设计的形状。 They will cut Nitinol tube, heat-treated molded into a desired shape design. 在与左心耳内壁接触的部位设计有向外翘起的锚定刺,刺入左心耳内壁,实现稳定固定。 At a portion in contact with the inner wall of the left atrial appendage designed with anchoring thorn tilt outwardly, the inner wall of the left atrial appendage puncturing to achieve stable fixation. 通常在切割型的网状框架上缝合有阻流膜, 实现左心耳闭塞的效果。 Usually sewn flow blocking effect film, to achieve the left atrial appendage occlusion-type mesh on the cutting frame. 这种结构设计的优势在于,整个封堵器一体成型,刚^较强,容易在左心耳内壁固定,所设计的锚定刺容易刺入左心耳内壁中,稳定固定,防止封堵器脱落。 This design has the advantage that the entire closure device is integrally formed, just ^ strong, easily fixed to the inner wall of the left atrial appendage, the anchoring thorn designed easily pierce the inner wall of the left atrial appendage, stable fixation, to prevent the occluder off. 但是切割型左心耳封堵器在形状上形变能力有限,无法适应形状各异的左心耳形态,使得它的使用受到很大的限制。 But cutting type left atrial appendage occluder limited in shape deformation ability, unable to adapt to exam left atrial appendage shapes, making its use much more restricted. 切割型左心耳封堵器在塞如左心耳后,在左心房内的部分通常会与心房壁比形成凹陷,形成新的“左心耳”区域,增加新的血栓形成的风险。 Cutting type in the left atrial appendage occluder plug as left atrial appendage, part of the left atrium generally formed than atrial wall with a recess, a new "LAA" area, increase the risk of new thrombosis. 切割型左心耳封堵器的锚定刺通常是刺向左心房,起到稳定封堵器,防止封堵器脱落。 Cutting type left atrial appendage occluder anchoring thorn prick is usually left atrium, stabilize the occluder to prevent the occluder off. 但是刺向左心房的锚定刺在重复定位,回收封堵器时会卡在鞘管壁边沿,使得封堵器无法回收,进行重复定位。 However, the left atrium barbed anchoring thorn in repositioning, get stuck in the wall of the sheath occluder edge during recovery, so that the occluder can not be recovered, repeated positioning.

[0007] 如发明专利CN201110146287和CNl〇3〇99652A所涉及的混合型左心耳封堵器。 [0007] The patent invention relates CNl〇3〇99652A CN201110146287 and mixed left atrial appendage occluder. 在这些设计中封堵盘采用编织的型式,通常在封堵盘内缝合有阻流膜,用于闭塞左心耳。 In these designs using braided occluder disk type, usually sewn baffle film used in occluding a left atrial appendage occluder disk. 而固定盘有镍钛金属管切割,热处理成型成所设计的形状。 Plate is fixed with a Nitinol tube cutting, heat-treated molded into a desired shape design. 在与左心耳内壁接触的部位设计有向外翘起的锚定刺,刺入左心耳内壁,实现稳定固定。 At a portion in contact with the inner wall of the left atrial appendage designed with anchoring thorn tilt outwardly, the inner wall of the left atrial appendage puncturing to achieve stable fixation. 混合型左心耳封堵器有效的解决了切割型左心耳封堵器的大部分问题。 Hybrid LAA occluder effectively solves most of the problems cutting type left atrial appendage occluder. 但是如在CN103099652A中固定盘的一个锚定刺通常是刺向左心房,起到稳定封堵器,防止封堵器脱落。 However, as in the fixed disk CN103099652A a barbed anchoring thorn is usually left atrium, stabilize the occluder, the occluder to prevent falling off. 但是刺向左心房的锚定刺在重复定位,回收封堵器时会卡在鞘管壁边沿,使得封堵器无法回收,进行重复定位。 However, the left atrium barbed anchoring thorn in repositioning, get stuck in the wall of the sheath occluder edge during recovery, so that the occluder can not be recovered, repeated positioning. 且这种混合型左心耳封堵器的固定盘通常形变较大,以翻转锚定刺的方向,导致固定盘的张力和形变量达到材料的极限值。 Such mixed and left atrial appendage occluder fixed disks usually large deformation, to reverse the direction barbed anchor, results in a fixed disk and the tension material deformation limit is reached. 这种器械在永久植入中的疲劳强度差,容易发生断裂,刺破心脏等其他组织,危及生命。 Such instruments permanently implanted in fatigue strength difference, breakage tends to occur, puncture other tissue in the heart, life-threatening.

[0008]因此,综合各种左心耳封堵器的优缺点,发展一种可有效闭塞左心耳的,可重复定位的,稳定固定的,可永久植入的左心耳封堵器。 [0008] Thus, the combination of all the advantages and disadvantages of the left atrial appendage occluder, the development of an effective occlusion of the left atrial appendage, repeatable positioning of stably fixed, permanently implantable left atrial appendage occluder.

[0009]因此,一种闭塞左心耳,阻断左心耳内血栓流出效果佳,可重复定位,固定稳定的, 耐疲劳的左心耳封堵系统。 [0009] Thus, one left atrial appendage occlusion, thrombus blocking the outflow of the left atrial appendage good effect, repeatable positioning, fixing stability, fatigue resistance of left atrial appendage occlusion system.

发明内容 SUMMARY

[0010]本发明的目的是提供一种闭塞左心耳,阻断左心耳内血栓流出效果佳,可重复定位,固定稳定的,耐疲5?的左心耳封堵系统。 [0010] The object of the present invention is to provide an occluding a left atrial appendage, left atrial thrombus block the outflow good effect, repeatable positioning, fixing stability, fatigue resistance 5? Left atrial appendage closure system.

[0011]为了实现上述目的,本发明提供的技术方案为:提供一种左心耳封堵系统,包括封堵盘和锚定盘,所述的封堵盘采用镍钛合金丝编织,经热处理成形成盘状结构,所述的锚定盘也采用镍钛合金丝编织,经热处理成形成柱状结构,两端用钢套固定,所述锚定盘至少包括一根粗丝,该粗丝由多根所述镍钛合金丝密绕而成,在所述锚定盘处于适当位置时,其中至少一根所述镍钛合金丝从所述锚定盘中向斜外方向伸出,作为锚刺,指向所述封堵盘,另外一根镍钛丝还作为编织网中的一根丝存在,起到连接上下两个钢套的作用。 [0011] To achieve the above object, the present invention provides technical solutions: providing a left atrial appendage occlusion system, comprising a blocking plate and anchor plate, said disc occluder using nitinol wire braid, heat-treated to disc-like structure is formed, the anchoring discs are also nitinol wire braid is heat treated to form a columnar structure, both ends of the steel sleeve secured to the anchor plate comprises at least one thick wire, a plurality of the thick filament the root nitinol wire tightly wound together, when the anchor plate is in place, wherein the at least one of said nitinol wire from the anchor plate extending obliquely outward direction, as a barbed anchor , directed towards the occluder disk, an additional nickel-titanium wire as a wire cloth also in the presence of two upper and lower connecting steel jacket play the role.

[0012]所述锚定盘展开时,所述锚定盘抵住左心耳内壁,所述锚刺刺入左心耳内壁,以稳定所述锚定盘在左心耳内的固定。 [0012] When the expanded anchor plate, the anchor plate against the inner wall of the left atrial appendage, the anchor spiked into the inner wall of the left atrial appendage, in order to stabilize the anchor plate is fixed within the left atrial appendage. 该左心耳封堵器可被拉直而拉入鞘管中,其中锚刺也可发生形变而被收入鞘管中,使得该封堵器实现可重复定位功能。 The left atrial appendage occluder may be pulled into the sheath tube to be straightened, in which the anchor may be deformed spines be its sheath tube, so that the occluder achieve repeatable positioning. 由于该左心耳封堵器是由金属丝编织而成,形变较小,耐疲劳性极高,可作为永久植入体植入体内。 As the left atrial appendage occluder braided wire made from a metal, deformation is small, high fatigue resistance, can be implanted in the body as a permanent implant.

[0013] 所述封堵盘上缝合PTFE或PET阻流膜。 [0013] The upper disc occluder suture PTFE or PET film choke. 为降低阻流膜表面血栓原性,加速封堵盘表面内皮化。 To reduce thrombus baffle immunogenic membrane surface, plugging the disk surface to accelerate endothelialization. 这样的阻流膜可采用静电纺丝纺制,并经低温等离子表面活化而成。 Such a film can be formed baffle electrospinning spinning, and activated from the surface by low-temperature plasma.

[0014] 每个所述锚刺的长度为0.5-10毫米。 [0014] each of the anchor barbed length of 0.5 to 10 mm.

[0015] 所述封堵盘和所述锚定盘可整体编织,经热处理而成。 [0015] The occluder plate and the anchor plate may be integrally woven, formed by heat treatment.

[0016] 所述封堵盘的一端装有螺纹连接器与输送推杆连接。 The [0016] occluder plate with a threaded connector end of the delivery pusher.

[0017」还包括推送器,所述封堵盘的一端螺纹连接所述推送器,所述封堵盘的一端装有多个金属丝,所述金属丝有体积较大的末端,该末端可被卡在推送器的连接件之间,所述封堵盘和所述推送器为柔性连接。 [0017 "further includes a pusher, the end of screwing the closure pusher plate, one end of the occluder plate with a plurality of wires, the wire has a larger volume tip that can be is caught between the pusher member is connected, said disc occluder and said pusher is a flexible connection.

[0018]与现有技术相比,本发明有如下优点: [0018] Compared with the prior art, the present invention has the following advantages:

[0019]本发明的左心耳封堵系统的锚定盘结构形变柔和,稳定。 [0019] The anchor plate structural deformation of the left atrial appendage occlusion system of the present invention is soft and stable. 永久植入的耐疲劳性能极佳。 Permanently implanted excellent fatigue resistance. 可适应各种形态和尺寸的左心耳腔体。 Can accommodate various sizes and forms a cavity left atrial appendage.

[0020]本发明的左心耳封堵系统的两段式设计,使得该封堵器可适应各种形态和尺寸的左心耳腔体。 [0020] The two-stage design of the left atrial appendage occlusion system of the present invention may be adapted such that the LAA occluder cavities of various forms and sizes.

[0021]本发明的左心耳封堵系统可同时具备锚定稳固,且有效闭塞左心耳。 [0021] The left atrial appendage occlusion system of the present invention may be provided simultaneously anchored securely, and efficiently closing the left atrial appendage.

[0022]本发明的左心耳封堵系统可重复定位。 [0022] The left atrial appendage occlusion system of the present invention is repeatable positioning. 在一些情况下如果放置效果不佳,在没有解脱输送推杆的情况,可将封堵器收回鞘管内,重复定位和放置,直至达到满意的锚定和闭塞的效果,大大降低手术风险。 In some cases ineffective if placed, in the absence of free delivery pusher, the occluder may be retracted the sheath, positioning and placement is repeated until a satisfactory anchoring and blocking effect, greatly reducing the risk of surgery.

[0023]本发明的左心耳封堵系统可使用较小的输送系统,进一步减小手术过程输送装置对血管的损伤。 [0023] The left atrial appendage occlusion system of the present invention may use a smaller delivery system, further reducing damage to the delivery device for surgery of blood vessels.

[0024]本发明的左心耳封堵系统与推送器的柔性连接,大大减小手术过程中推送器对该封堵器施加的张力,使得封堵器放置的位置更加准确。 [0024] The flexible connecting left atrial appendage occlusion pusher system of the present invention greatly reduces the surgical procedure push the tension applied by the occluder, the occluder is placed such that the position is more accurate.

[0025]通过以下的描述并结合附图,本发明将变得更加清晰,这些附图用于解释本发明的实施例。 [0025] the following description in conjunction with the accompanying drawings, the present invention will become apparent from these drawings to explain an embodiment of the present invention.

附图说明 BRIEF DESCRIPTION

[0026]图1为本发明左心耳封堵系统的第一实施例的前视图。 [0026] FIG. 1 is a front view of a first embodiment of left atrial appendage occlusion system of the present invention.

[0027]图2为如图1所^的左心耳封堵系统的的密绕金属丝和锚刺的局部放大图。 [0027] FIG. 2 is a tightly wound wire ^ and barbed anchors partially enlarged view of the left atrial appendage occlusion system.

[0028]图3为如图1所示的左心耳封堵系统的锚定盘仰视图。 [0028] FIG. 3 is a bottom view of the left atrial appendage occlusion anchor plate system shown in FIG.

[0029]图4为如图1所示的左心耳封堵系统的锚定盘俯视图。 [0029] FIG 4 a plan view of an anchor plate for the left atrial appendage occlusion system 1 shown in FIG.

[0030] 图5为本发明左心耳封堵系统的第二实施例的前视图。 Front view of a second embodiment [0030] FIG. 5 left atrial appendage occlusion system of the present invention.

[0031] 图6为如图5所示的左心耳封堵系统的第二实施例的锚定盘仰视图。 [0031] FIG. 6 is a left atrial appendage occlusion system shown in Figure 5 of a second embodiment of the anchor plate bottom FIG.

[0032] 图7为如图5所示的左心耳封堵系统的第二实施例的锚定盘俯视图。 [0032] FIG. 7 is a plan view of an anchor plate of a second embodiment of left atrial appendage occlusion system as shown in FIG.

[0033]图8a为本发明左心耳封堵系统的第三实施例的锚定刺的一种形式的放大图。 Anchoring thorn third embodiment given an enlarged view of one form of the [0033] present invention, FIG. 8a left atrial appendage occlusion system.

[0034]图8b为本发明左心耳封堵系统的第三实施例的锚定刺的另一种形式的放大图。 Anchoring thorn enlarged view of another embodiment of a third form of embodiment of left atrial appendage occlusion System [0034] FIG. 8b present invention.

[0035] 图8c为本发明左心耳封堵系统的第三实施例的锚定刺的又一种形式的放大图。 Yet another form of an enlarged view of the anchoring thorn [0035] FIG. 8c according to a third embodiment of a left atrial appendage closure system of the invention.

[0036] 图9本发明的左$、耳封堵系统在左心耳解剖结构中的位置示意图。 [0036] FIG. 9 $ left the present invention, the position of the block schematic diagram of the system in the ear anatomy of the left atrial appendage.

[0037] 图10为如图1所^的左心耳封堵系统完全被拉入鞘管的状态示意图。 Left atrial appendage occlusion system [0037] FIG. 10 is a diagram showing a state ^ completely pulled into the sheath tube.

[0038] 图11为如图1所^的左心耳封堵系统的部分锚定盘被拉入鞘管的状态示意图。 A portion of the left atrial appendage occlusion system [0038] FIG. 11 is a diagram showing a state ^ anchor plate to pull the sheath tube.

[0039] 图12为如图1所f的左心耳封堵系统的封堵盘被拉入鞘管的状态示意图。 [0039] FIG. 12 is a view showing a state in FIG. 1 f left atrial appendage occlusion disc occluder is pulled into the sheath tube system.

[0040]图13为如图1所示的左心耳封堵系统完全出鞘管的状态示意图。 [0040] FIG. 13 is a left atrial appendage occlusion system state as shown in sheath was entirely schematic.

[0041]图14为本发明左心耳封堵系统的第三实施例的前视图。 Front view of a third embodiment [0041] FIG. 14 left atrial appendage occluder system of the present invention.

具体实施方式 detailed description

[0042]现在参考附图描述本发明的实施例,附图中类似的元件标号代表类似的元件。 [0042] Referring now to the accompanying drawings of embodiments of the present invention, the accompanying drawings in which like numerals represent like element elements throughout.

[0043] 实施例1 [0043] Example 1

[0044]如图1,图2和图3所示,本发明所涉及左心耳封堵系统100,包括有封堵盘1,与封堵盘1连接的锚定盘2,其中如图3所示,封堵盘1用镍钛丝编织成编织网,经热处理成盘状,两端用钢套固定,封堵盘1的一端和锚定盘2用钢套4连接。 [0044] As shown in FIG. 1, 2 and 3, the present invention relates to a left atrial appendage occlusion system 100, including a disc occluder, the occluder disk 1 is connected to the anchoring plate 2, FIG. 3 wherein shown, sealing plate with a woven braid of nickel titanium wire, disk-shaped heat-treated, the steel sleeve secured at both ends, one end of the occluder disk 1 and the anchor plate 4 is connected to 2 sets of steel. 另一端设置有螺纹的螺母3与输送装置的推送器连接。 The other end is provided with a threaded nut 3 is connected to the pusher delivery device. 同样的,锚定盘2也是用镍钛丝8编织成编织网(如图2所示),经热处理成盘状,两端用钢套4固定,封堵盘1和锚定盘2内部分别缝合有PFTE或PET阻流膜,其中,用于编织锚定盘2的镍钛丝中有6根,镍钛丝6是由两根镍钛丝密绕而成。 Similarly, the anchor plate 2 are woven into a nickel-titanium wire braid 8 (FIG. 2), disk-shaped heat-treated, the steel sleeve 4 is fixed at both ends, and a second inner sealing plate anchor plate each PFTE or sewn choke PET film, wherein a woven nitinol wire anchor plate 2 there are 6, nickel-titanium wire 6 by two nickel-titanium wire tightly wound together. 在编织编织时,密绕的镍钛丝6与其他单根的镍钛丝采用相同的编织方式编织。 When knitting the knitting, a tightly wound braided nitinol wires 6 and the other a single nickel-titanium wire knitting the same manner. 在热处理定型时将密绕的镍钛丝6中的一根镍钛丝从密绕的镍钛丝6中分出来,并修剪定型成钩状,形成锚刺7,位于锚定盘2的侧面,另外一根镍钛丝10还作为编织网中的一根丝存在,起到连接上下两个钢套4的作用。 When setting the heat treatment of a nickel-titanium wire tightly wound Nitinol wire 6 from the equatorial nickel titanium wire tightly wound out 6, and trimmed into a hook shape, the anchoring thorn 7 is formed, at the side of the anchor plate 2 in addition a nickel-titanium wire 10 also serves as a wire braid in the presence of functioning for connection of the upper and lower steel jacket 4. 其中锚刺7呈近似半圆形,向锚定盘2外张开,其末端朝向封堵盘1方向。 Thorn 7 wherein the anchor has a substantially semi-circular, open to the anchor plate 2, its direction toward the end of the occluder disk. 锚刺7在不受压力的情况下自动向外张开,并可刺入左心耳内壁的组织内。 7 barbed anchor automatically without being flared pressure, piercing the tissue and the inner wall of the left atrial appendage. 压缩时该锚刺7可受力变形, 可回收入鞘管内。 The barbed anchor 7 may be deformed by the compression force, be recovered within the sheath tube.

[0045]如图10,图11,图I2和图13所示,左心耳封堵系统在受推送器15的拉力作用进入鞘管14 (B方向)和受推送器I5推力作用从鞘管14里出来(A方向)的过程有如下特点:左心耳封堵系统的封堵盘1和锚定盘2被拉直压缩在鞘管14内,其中锚刺7被拉伸变形,挤压在窄小的鞘管14内。 [0045] As shown in FIG 10, FIG 11, FIG I2 and 13, left atrial appendage occlusion system by pulling action of the pusher 15 enters 14 (B direction) by the sheath and I5 thrust from the pusher sheath 14 out in (a direction) of the process has the following characteristics: a left atrial appendage occlusion system occluder disk 1 and the disk 2 is straightened anchor compressed within the sheath 14, wherein the anchor 7 is barbed tensile deformation, pressing the narrow within a small sheath 14. 在推送器15的推力作用下,锚定盘2首先被推出鞘管14。 Under the thrust of the pusher 15, the anchor plate 2 is first sheath tube 14 is pushed. 由于镍钛合金具有形状记忆和超弹性的优越性能,锚定盘2和锚刺7迅速回复原始状态。 Since nickel-titanium alloy having shape memory and superelastic superior performance, the anchoring plate 2 and the anchoring thorn 7 quickly restore the original state. 锚定盘2的侧面紧贴左心耳内壁,它的锚刺刺入左心耳内壁组织,牢牢固定锚定盘2的位置。 Anchor plate 2 side close to the inner wall of the left atrial appendage, its anchor spiked into the inner wall of the left atrial appendage tissue, firmly fixed anchor plate in position 2. 推送器15继续施加推送力, 将封堵盘1推出鞘管。 Pusher 15 continues to apply a force pushing the occluder disk 1 Release sheath. 封堵盘1也迅速回复原始状态。 Occluder disk 1 also quickly returned to its original state. 封堵盘1靠近锚定盘2的一面将贴合左心耳的外沿,隔离左心房与左心耳的通路,起到封堵左心耳的目的。 Occluder disk 1 near one side of the anchor plate attached to the outer edge of the left atrial appendage. 2, left atrium and the left atrial appendage isolation passage, serve the purpose of plugging the left atrial appendage. 在推送器15施加拉力作用回收左心耳封堵系统的B过程与推送器15施加推力作用推出左心耳封堵系统的A过程的各个阶段相反。 Pulling force acting pusher 15 left atrial appendage occlusion in the recovery process and system B is applied to the thrust of the pusher 15 opposite to each stage of Release A process left atrial appendage occlusion system. 左心耳封堵系统沿方向B被推送器15拉入鞘管14,显著的特点是,锚刺7由展开时朝向封堵盘的斜外侧方向形变朝向钢套4的斜外侧方向。 Characteristics of left atrial appendage occlusion system 15 is pulled in the direction B into the sheath tube pusher 14, notably, barbed anchor 7 toward the obliquely outward direction from the deformation of the deployed occluder disk obliquely outward direction of the steel jacket 4. 这个过程确保锚刺7不会刮伤左心耳壁,并能顺利进入鞘管14。 This process ensures that the anchor thorn 7 will not scratch the walls of the left atrial appendage, and can successfully enter the sheath 14. 本实施例的左心耳封堵系统不仅能确保锚定盘2在左心耳内的可重复定位功能,还大大减少器械对左心耳壁的损伤,降低手术的风险和并发症。 Left atrial appendage occluder system of this embodiment can not only ensure the anchoring plate 2 may be repeated positioned within the left atrial appendage function, but also greatly reduce damage to the instrument left atrial wall, and reduce the risk of surgical complications.

[0046] 实施例2 [0046] Example 2

[0047]如图5,图6和图7所示,本发明所涉及左心耳封堵系统包括有封堵盘1,与封堵盘1 连接的锚定盘2。 As shown in [0047] 5, 6 and 7, the present invention relates to a system comprising a left atrial appendage occlusion occluder disk 1, and an anchor connected to the occluder disk platen 2. 封堵盘1与锚定盘2采用一体式设计。 1 occluder disk 2 and the anchor plate one-piece design. 采用镍钛丝编织成编织网,两端用钢套4固定,经热处理成双盘结构,在封堵盘丨和锚定盘2之间有较细小的腰部n。 Nickel titanium wire woven into a braid, both ends of the sleeve 4 is fixed steel, heat-treated double disc structure, and the occluder disk Shu anchor plate has finer waist between 2 n. 封堵盘丨的另一端设置有螺纹3,与输送装置的推送器15连接。 The other end of the occluder disk Shu is provided with a thread 3, the pusher is connected to the delivery device 15. 封堵盘1和锚定盘2内部分别缝合有PFTE或PET阻流膜。 Internal occluder disk 2 and the anchor plate 1 are sewn choke PFTE or PET film. 其中,用于编织的镍钛丝中有8根镍钛丝6是由两根镍钛丝密绕而成。 Wherein the nickel-titanium wire for knitting has a nickel titanium wire 6 8 by two nickel-titanium wire tightly wound together. 在编织时, 密绕的镍钛丝6与其他单根的镍钛丝采用相同的编织方式编织。 When weaving, a tightly wound braided nitinol wires 6 and the other a single nickel-titanium wire knitting the same manner. 在热处理定型时将密绕的镍钛丝6中的一根镍钛丝从密绕的镍钛丝6中分出来,并修剪定型成钩状,形成锚刺7,位于锚定盘的侧面,另外一根镍钛丝10还作为编织网中的一根丝存在,起到连接上下两个钢套4 的作用。 When setting the heat treatment of a nickel-titanium wire tightly wound wire 6 from Nitinol nickel-titanium wire tightly wound 6 carved out, trimmed and shaped like a hook, barbed anchor 7 is formed at the side of the anchor plate, also a nickel-titanium wire 10 also serves as a wire braid in the presence of functioning for connection of the upper and lower steel jacket 4. 其中锚刺7呈近似半圆形,向锚定盘2外张开,其末端朝向封堵盘1方向。 Thorn 7 wherein the anchor has a substantially semi-circular, open to the anchor plate 2, its direction toward the end of the occluder disk. 锚刺7在不受压力的情况下自动向外张开,并可刺入左心耳内壁的组织内。 7 barbed anchor automatically without being flared pressure, piercing the tissue and the inner wall of the left atrial appendage. 压缩时该锚刺7可受力变形,可回收入鞘管内。 The barbed anchor 7 may be deformed by the compression force, be recovered within the sheath tube.

[0048] 实施例3 [0048] Example 3

[0049]如图14所示,本发明所涉及左心耳封堵系统包括有封堵盘1,与封堵盘1连接的锚定盘2。 [0049] 14, according to the present invention comprises a left atrial appendage occluder system occluder disk 1, and an anchor connected to the occluder disk platen 2. 封堵盘1和与封堵盘1连接的锚定盘2采用一体式设计。 An anchor plate and a sealing plate connected to a sealing plate 2 one-piece design. 采用镍钛丝编织成编织网,两端用钢套4固定,经热处理成双盘结构。 Nickel titanium wire woven into a braid, both ends of the sleeve 4 is fixed steel, heat-treated double disc structure. 封堵盘1的另一端设置有螺纹3,与输送装置的推送器I5连接。 The other end of the occluder disk 1 is provided with a thread 3, I5 is connected to the push delivery device. 封堵盘1和锚定盘2内部分别缝合有PFTE或PET阻流膜。 Internal occluder disk 2 and the anchor plate 1 are sewn choke PFTE or PET film. 其中,用于编织的镍钛丝中有8根镍钛丝6是由两根镍钛丝密绕而成。 Wherein the nickel-titanium wire for knitting has a nickel titanium wire 6 8 by two nickel-titanium wire tightly wound together. 在编织时,密绕的镍钛丝6与其他单根的镍钛丝采用相同的编织方式编织。 When weaving, a tightly wound braided nitinol wires 6 and the other a single nickel-titanium wire knitting the same manner. 在热处理定型时将密绕的镍钛丝6中的一根镍钛丝从密绕的镍钛丝6中分出来,并修剪定型成钩状,形成锚刺7,位于锚定盘的侧面,另外一根镍钛丝10还作为编织网中的一根丝存在,起到连接上下两个钢套4的作用。 When setting the heat treatment of a nickel-titanium wire tightly wound wire 6 from Nitinol nickel-titanium wire tightly wound 6 carved out, trimmed and shaped like a hook, barbed anchor 7 is formed at the side of the anchor plate, also a nickel-titanium wire 10 also serves as a wire braid in the presence of functioning for connection of the upper and lower steel jacket 4. 其中锚刺7呈近似半圆形,向锚定盘2外张开,其末端朝向封堵盘1方向。 Thorn 7 wherein the anchor has a substantially semi-circular, open to the anchor plate 2, its direction toward the end of the occluder disk. 锚刺7在不受压力的情况下自动向外张开,并可刺入左心耳内壁的组织内。 7 barbed anchor automatically without being flared pressure, piercing the tissue and the inner wall of the left atrial appendage. 压缩时该锚刺7可受力变形,可回收入鞘管内。 The barbed anchor 7 may be deformed by the compression force, be recovered within the sheath tube.

[0050] 如图8a、8b、8c所示,密绕的镍钛丝和锚刺的表现形式。 [0050] FIG. 8a, 8b, as shown in 8c, a tightly wound nitinol wire anchor and forms spines. 其中图8a所示密绕的镍钛丝由两根镍钛丝密绕而成在热处理定型时将密绕的镍钛丝6中的一根镍钛丝从密绕的镍钛丝6中分出来,并修剪定型成钩状,形成锚刺7,位于锚定盘的侧面,另外一根镍钛丝10还作为编织网中的一根丝存在,起到连接上下两个钢套4的作用。 Wherein FIG tightly wound nitinol wires 8a shown by the two nickel-titanium wire tightly wound setting will be made during the heat treatment of the nickel-titanium wire tightly wound nitinol wire in a 6 carved from a nickel titanium wire tightly wound 6 out, trimmed and shaped like a hook, barbed anchor 7 is formed, a side plate located on the anchor, an additional nickel-titanium wire 10 is also present as a woven mesh of filaments, connected to function as two vertical steel sleeve 4 . 其中图8b所示密绕的镍钛丝由三根镍钛丝密绕而成在热处理定型时将密绕的镍钛丝6中的一根镍钛丝从密绕的镍钛丝6 中分出来,并修剪定型成钩状,形成锚刺7,位于锚定盘的侧面,另外两根镍钛丝密绕成镍钛丝12还作为编织网中的一根丝存在,起到连接上下两个钢套4的作用。 Shown wherein a nickel titanium wire tightly wound by the three nickel-titanium wire tightly wound setting will be made during the heat treatment of the nickel-titanium wire tightly wound a nickel-titanium wire 6 from a nickel titanium wire tightly wound FIG. 8B branched off 6 , trimmed and shaped like a hook, barbed anchor 7 is formed, a side plate located in the anchor, the other two nickel-titanium wire wound into a tight nitinol wire 12 also functions as a wire cloth, in the presence of two upper and lower connecting functions steel jacket 4 functions. 其中图8c所示密绕的镍钛丝由三根镍钛丝密绕而成在热处理定型时将密绕的镍钛丝6中的两根镍钛丝从密绕的镍钛丝6中分出来,分别修剪定型成钩状,形成两个锚刺13,位于锚定盘的侧面,另外一根镍钛丝密绕成镍钛丝10还作为编织网中的一根丝存在,起到连接上下两个钢套4的作用。 Wherein two nickel FIG nickel titanium wire tightly wound around 8c formed as shown by the three nickel-titanium wire dense amorphous during the heat treatment of the nitinol wire closely wound wire 6 from the titanium-nickel-titanium wire wound densely branched off 6 were trimmed to shape hook, anchor two spines 13 are formed, located on the side surface plate of the anchor, an additional nickel-titanium wire wound into a tight nitinol wire 10 is also present as a woven mesh of filaments, connected to the vertical play two steel jacket 4 functions.

[0051]如图9所示,本发明的左心耳封堵系统在左心房LA的左心耳LAA内的放置示意图。 [0051] As shown in FIG. 9, a schematic view of left atrial appendage occlusion placement system of the invention in the left atrial appendage LAA of the left atrium LA. 本发明的左心耳封堵系统具有弹性和伸缩性的锚定盘2,使得锚定盘2可根据临床需要放置在较深或较浅的位置。 Left atrial appendage occlusion system of the present invention and having an elastic stretchability anchor plate 2, such that the anchoring plate 2 may be disposed according to clinical need dark or light position.

[0052]综上所述,本发明的左心耳封堵系统包括有封堵盘和锚定盘,具有良好的弹性和闭塞性能。 [0052] In summary, the left atrial appendage occlusion system of the present invention comprises a disc occluder and anchor plate, and having good elastic properties occlusion. 该封堵器整体结构稳定性好,可重复定位,锚定稳固,可适应各种左心耳形态,减少手术难度和对组织的损伤。 The occluder unitary structure stability, repeatable positioning, anchoring stable, can be adapted to various forms left atrial appendage, the difficulty of operation and reduce tissue damage. 该封堵器包括具有良好弹性且内缝合有阻流膜的封堵盘,其封堵盘通过一体或分段连接一个具有弹性的锚定盘,该锚定盘具有良好的形变能力,使得该左心耳封堵系统适应各种左心耳形态。 The occluder includes a good elasticity and the occluder disk sewn baffle film, a sealing plate connected with the anchor plate by an elastic integral or segmented, the anchor plate having good deformation capability, such that left atrial appendage occlusion system to adapt to exam left atrial appendage. 该锚定盘的上有锚刺,可随自然伸展刺向左心耳内壁,大大增强锚刺的锚定能力,减少锚刺对组织的损伤,使得该封堵器具有重复定位的功能。 The anchor plate has a barbed anchor, can puncture the left atrial appendage with the inner wall extends naturally, greatly enhance the ability to anchor the anchoring thorn, reduce tissue damage barbed anchor, such that the occluder has a repeatable positioning function. 这种锚刺的一体设计,整体的形变小,应力小,降低永久植入发生断裂的风险,也使得本发明的左心耳封堵系统使用较小的输送系统。 This anchoring thorn integrally design, the overall deformation, small stress, reduces the risk of breakage of permanently implanted, also makes the left atrial appendage occlusion system of the present invention is the use of smaller delivery systems.

[0053]因此,本发明具有以下优点: [0053] Accordingly, the present invention has the following advantages:

[0054] 本发明的左心耳封堵系统的锚定盘结构形变柔和,稳定,永久植入的耐疲劳性能极佳,可适应各种形态和尺寸的左心耳腔体。 [0054] The anchor plate structural deformation soft, stable, excellent fatigue resistance permanently implanted, the cavity can be adapted to various forms left atrial appendage and sizes of the left atrial appendage occlusion system of the present invention.

[0055] 本发明的左心耳封堵系统的两段式设计,使得该封堵器可适应各种形态和尺寸的左心耳腔体,闭塞效果极佳。 [0055] The two-stage design of the left atrial appendage occlusion system of the present invention may be adapted such that the LAA occluder cavities of various forms and sizes, an excellent blocking effect.

[0056] 本发明的左心耳封堵系统可同时具备锚定稳固,且有效闭塞左心耳。 Left atrial appendage occlusion system [0056] The present invention may also have anchor securely, and efficiently closing the left atrial appendage.

[0057] 本发明的左心耳封堵系统可重复定位,在一些情况下如果放置效果不佳,在没有解脱输送推杆的情况,可将封堵器收回鞘管内,重复定位和放置,直至达到满意的锚定和闭塞的效果,大大简化手术过程,降低手术难度和风险。 [0057] The left atrial appendage occlusion system of the present invention is repeatable positioning, in some cases ineffective if placed, in the absence of free delivery pusher, the occluder may be retracted the sheath, positioning and placement is repeated, until satisfactory anchoring and blocking effect, greatly simplifying the surgical procedure, reduce surgical difficulty and risk.

[0058]本发明的左心耳封堵系统可使用较小的输送系统,进一步减小手术过程输送装置对血管的损伤。 [0058] The left atrial appendage occlusion system of the present invention may use a smaller delivery system, further reducing damage to the delivery device for surgery of blood vessels.

[0059]本发明的左心耳封堵系统与推送器的柔性连接,大大减小手术过程中推送器对该封堵器施加的张力,使得封堵器放置的位置更加准确。 [0059] The left atrial appendage occlusion system is connected with a flexible pusher present invention greatly reduces the surgical procedure to push the tension applied by the occluder, the occluder is placed such that the position is more accurate.

[0060]以上所述仅为本发明的较佳实施例而己,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替代和改进等,均应包含在本发明的保护范围之内。 [0060] The foregoing is only preferred embodiments of the present invention and have not to limit the present invention, any modifications within the spirit and principle of the present invention, equivalent substitutions and improvements should be included in the within the scope of the present invention.

Claims (6)

  1. 1. 一种左心耳封堵系统,其特征在于:包括封堵盘和锚定盘,所述的封堵盘采用镍钛合金丝编织,经热处理成形成盘状结构,所述的锚定盘也采用镍钛合金丝编织,经热处理成形成柱状结构,两端用钢套固定,所述锚定盘至少包括一根粗丝,该粗丝由多根所述镍钛合金丝密绕而成,在所述锚定盘处于适当位置时,其中至少一根所述镍钛合金丝从所述锚定盘中向斜外方向伸出,作为锚刺,每个所述锚刺的长度为0.5-10毫米,指向所述封堵盘,另外一根镍钛丝还作为编织网中的一根丝存在,起到连接上下两个钢套的作用,还包括推送器, 所述封堵盘的一端螺纹连接所述推送器,其中,推送器施加拉力作用回收左心耳封堵系统时,所述锚刺可由展开时朝向封堵盘的斜外侧方向形变为收缩时朝向钢套的斜外侧方向。 A left atrial appendage occlusion system comprising: a disk occluder and anchor plate, said disc occluder using nitinol wire braid is heat treated to form a disk-like structure, said anchor plate nitinol wire braided also be used, heat-treated to form a columnar structure, both ends of the steel sleeve secured to the anchor plate comprises at least one thick wire, a thick wire which a plurality of said nitinol wire tightly wound together when the anchor plate is in place, wherein the at least one of said nitinol wire from the anchor plate extending obliquely outward direction, as barbed anchor, each said anchor length of 0.5 thorn -10 mm, the occluder disk point, an additional nickel-titanium wire also serves as a wire braid is present, acts as the upper and lower connecting steel sleeve, further comprising a pusher, said disc occluder toward the end of the occluder disk when the threaded connection of the pusher, wherein the pusher when the pulling force acting left atrial appendage occlusion recovery system, the anchor may expand the thorn-shaped oblique outward direction becomes a direction toward the inclined outer steel sleeve contraction.
  2. 2.如权利要求1所述的左心耳封堵系统,其特征在于:所述锚定盘展开时,所述锚定盘抵住左心耳内壁,所述锚刺刺入左心耳内壁,以稳定所述锚定盘在左心耳内的固定。 2. The left atrial appendage occlusion system according to claim 1, wherein: said deployment anchor plate, the anchor plate against the inner wall of the left atrial appendage, the anchor spiked into the inner wall of the left atrial appendage, in order to stabilize the anchor is fixed in the left atrial appendage disc.
  3. 3.如权利要求1所述的左心耳封堵系统,其特征在于:所述封堵盘上缝合PTFE或PET阻流膜。 Left atrial appendage occlusion system according to claim 1, wherein: said spoiler suture PTFE or PET film occluder disk.
  4. 4.如权利要求1所述的左心耳封堵系统,其特征在于:所述封堵盘和所述锚定盘可整体编织,经热处理而成。 4. The left atrial appendage occlusion system according to claim 1, wherein: said closure plate and said anchor plate may be integrally woven, formed by heat treatment.
  5. 5.如权利要求1所述的左心耳封堵系统,其特征在于:所述封堵盘的一端装有螺纹连接器与输送推杆连接。 5. The left atrial appendage occlusion system according to claim 1, wherein: one end of the occluder plate with a threaded connector to the delivery plunger.
  6. 6.如权利要求1所述的左心耳封堵系统,其特征在于:所述封堵盘的一端装有多个金属丝,所述金属丝有体积较大的末端,该末端可被卡在推送器的连接件之间,所述封堵盘和所述推送器为柔性连接。 6. The left atrial appendage occlusion system according to claim 1, wherein: said one end of the occluder disk with a plurality of wires, the wire end has a larger volume, which can be stuck in the end connection between the pusher member, said disc occluder and said pusher is a flexible connection.
CN 201410537620 2014-10-13 2014-10-13 Left atrial appendage occlusion system CN104352260B (en)

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CN104958087A (en) * 2015-07-28 2015-10-07 杭州德诺科技有限公司 A left auricle occluding device
CN105054985B (en) * 2015-07-28 2018-05-01 杭州诺茂医疗科技有限公司 An improved left atrial appendage occluder
CN106923886A (en) * 2015-12-31 2017-07-07 先健科技(深圳)有限公司 Left auricle occluder
CN106923884A (en) * 2015-12-31 2017-07-07 先健科技(深圳)有限公司 Left auricle occluder
CN106344100A (en) * 2016-10-11 2017-01-25 北京工业大学 Left auricle plugging device

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