CN101961274A - Blood vessel necking device and controlled release system - Google Patents

Blood vessel necking device and controlled release system Download PDF

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Publication number
CN101961274A
CN101961274A CN 201010521767 CN201010521767A CN101961274A CN 101961274 A CN101961274 A CN 101961274A CN 201010521767 CN201010521767 CN 201010521767 CN 201010521767 A CN201010521767 A CN 201010521767A CN 101961274 A CN101961274 A CN 101961274A
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end
mouthpiece
sheath
stent
bracket
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CN 201010521767
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Chinese (zh)
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王永胜
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先健科技(深圳)有限公司
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Abstract

The invention relates to a blood vessel necking device, which comprises a retractable multilayer netlike bracket. The bracket is provided with a near end and a remote end; the innermost layer of the bracket is provided with a pipe orifice facing the near end of the bracket; the outermost layer of the bracket is provided with a pipe orifice facing the remote end of the bracket; a transition section is arranged between the innermost layer and the outermost layer and comprises a conical tube structure, a corrugated tube structure, a multilayer folding structure or the combination of the three structures; and the transition section is provided with a first end close to the near end of the bracket and a second end close to the remote end of the bracket, the first end is close to the innermost layer of the bracket, the second end is close to the outermost layer of the bracket, and the internal diameter of the first end is smaller than the external diameter of the second end. The invention also relates to a controlled release system. The blood vessel necking device repairs the pulmonary valve subjected to hemangiectasis by a minimally invasive intervention method, does not depend on surgical operation any more and reduces the trauma of patients and the risk of the operation.

Description

血管缩口器及可控释放系统 Mouthparts shrink blood vessels and controlled release systems

技术领域 FIELD

[0001] 本发明涉及一种医疗器械,尤其涉及一种可用于肺动脉血管腔内的血管缩口器及可控释放系统。 [0001] The present invention relates to a medical instrument, particularly to a vessel for condensing pulmonary artery lumen mouthparts and controlled release systems.

背景技术 Background technique

[0002] 法氏四联症是临床上一种较常见的发绀型先心病,约占10% _15%。 [0002] Act Fallot is a relatively common clinical cyanotic congenital heart disease, accounting for about 10% _15%. 是存活婴儿中最常见的一种发绀型先心病,在1岁以后的发绀型先心病中约占70%。 Infant survival is the most common form of cyanotic congenital heart disease, accounting for about 70% after 1 year in cyanotic congenital heart disease. 典型的法氏四联症包括肺动脉狭窄、室间隔缺损、主动脉骑跨、右心室肥厚,其中肺动脉狭窄是法氏四联症中最主要的病变,也是影响本病病理生理和临床表现的重要因素。 A typical method comprises Fallot pulmonary stenosis, ventricular septal defect, aorta, right ventricular hypertrophy, pulmonary stenosis where Fallot method is the most important disease, but also affect the disease pathophysiology and clinical manifestations important factor.

[0003] 对于婴幼儿患者主要是采用分期手术治疗,首先进行姑息手术,主要是增加肺循环血流量,改善心肺功能,最后进行根治手术。 [0003] For infants and young children is mainly used in patients with stage surgery, the first palliative surgery, mainly to increase blood flow to the pulmonary circulation, improve heart and lung function, and finally radical surgery. 一期手术完成后,很多患者肺动脉瓣会发生扩张,闭合后仍会产生血液返流。 After a completion of the operation, many patients pulmonary valve dilation occurs, will produce regurgitation after closing. 二期手术中需要恢复此处肺动脉瓣的功能,目前普遍是采用外科手术治疗。 Two surgery here in the need to restore the function of the pulmonary valve, the current widespread is the use of surgery. 但是采用两次外科手术会增大对病人的风险性。 But the use of two surgical procedures increases the risk to the patient.

[0004] 采用经皮介入方式修复肺动脉瓣,可以大幅较少对病人的创伤,缩短康复周期,从而显著降低手术风险。 [0004] percutaneous pulmonary valve repair interventions can be significantly less patient trauma, shorten the rehabilitation period, thereby significantly reducing the risk of surgery. 现在介入肺动脉瓣的技术已经相对成熟,在市场上得到了广泛的应用。 Now the pulmonary valve intervention technology is relatively mature, the market has been widely used. 但是目前介入肺动脉瓣的直径都比较小,一般不超过22毫米,通常不能在法氏四联症患者一期手术后的肺动脉瓣处固定。 However, the diameter of the pulmonary valve currently involved are relatively small, generally not more than 22 mm, usually the pulmonary valve can not be fixed in the method Fallot patients place a procedure. 因此肺动脉介入瓣技术目前还不能在法氏四联症一期手术后的患者中进行应用。 Therefore, the pulmonary valve intervention technology is not ready for use in patients after the law Fallot a surgery.

[0005] 针对法氏四联症患者一期手术后肺动脉瓣扩张的状况,因介入瓣膜直径不够大, 通常无法采用介入瓣膜置换,只能采用外科手术修复的方法进行治疗。 [0005] For pulmonary valve dilatation of the situation after the law Fallot patients with a surgery, due to valvular involvement is not large enough in diameter, valve replacement is usually not interventional, surgical repair can only method of treatment. 外科手术对病人的创伤大,况且病人连续承受两次外科手术,对病人的风险更大。 Surgical trauma to the patient's large, besides two consecutive patients subjected to surgery, the greater the risk to the patient. 除了法氏四联症一期手术后患者,还有其他一些先天性心脏病患者需要置换肺动脉瓣,如果肺动脉口部也超过介入肺动脉瓣直径很多,那么后者也不能适用介入治疗。 In addition to the law Fallot a surgery, there are other congenital heart disease patients need replacement pulmonary valve, pulmonary artery if the mouth is also involved in a lot more than the diameter of the pulmonary valve, the latter can not be applied intervention. 因此,需要发展现有的介入治疗技术,对于肺动脉口部直径较大的情况,也采用介入方式顺利置换肺动脉瓣,以降低法氏四联症患者和其他患者的治疗风险。 Therefore, the need to develop the existing intervention techniques, for larger cases of pulmonary mouth diameter, also smooth the way interventional pulmonary valve replacement in order to reduce the risk of patient treatment method Fallot and other patients.

发明内容 SUMMARY

[0006] 本发明要解决的技术问题在于提供一种血管缩口器及可控释放系统,以解决现有技术中不能通过介入的方式修复肺动脉瓣,只能采用外科手术修复的方法进行治疗,进而对病人的创伤增大,对病人的手术风险性增大等问题。 [0006] The present invention is to solve the technical problem is to provide a controlled release vessels and condensing systems mouthparts to solve the prior art can not be restored with the intervention of the pulmonary valve, the method can only be treated surgically repair, thus increasing trauma to the patient, the patient's surgical risk increases and other issues.

[0007] 解决本发明的技术问题所采用的技术方案是:一种血管缩口器,其包括一个可收缩的多层的网状支架,所述支架有一近端和一远端,所述支架的最内层有一管口朝向所述支架的近端,所述支架的最外层设有一管口朝向所述支架的远端,所述最内层与最外层之间设有一过渡段,所述过渡段包括圆锥管结构、波纹管结构、多层折叠结构或者三种结构相互组合的结构,所述过渡段设有靠近所述支架的近端的第一端和靠近所述支架的远端的第二端,所述第一端靠近所述支架的最内层,所述第二端靠近所述支架的最外层,所述第一端 [0007] Solving the problem of the invention is employed: an intravascular contraction mouthpiece, comprising a collapsible multilayer mesh stent, the stent having a proximal end and a distal end, the stent the innermost layer has an opening towards the proximal end of the stent, the stent is provided with the outermost distal end of an opening of the bracket toward the most inner and the outermost layer is provided between a transition section, the structure comprises a conical transition section pipe structure, the bellows structure, folded structure or a multilayer structure of three kinds of combination with each other, a first end of the transition section is provided near the distal and proximal stent adjacent said stent the outermost end of the second end, the first end adjacent to the innermost layer of the stent, the stent proximate the second end, the first end

3的内径小于第二端的外径。 3 is smaller than that of the inner diameter of the second end.

[0008] 作为本发明血管缩口器的进一步改进,进一步包括设置在所述过渡段上的阻流膜,设置所述阻流膜的区域包括所述过渡段的第一端和第二端。 [0008] The present invention reduced blood vessel further improvement mouthpiece, further comprising a flow blocking film disposed on the transition section, the disposed area of ​​said flow blocking film comprises a first end and a second end of the transition section.

[0009] 作为本发明血管缩口器的进一步改进,所述阻流膜的材质为PET或者e-PTFE材料。 [0009] The present invention reduced blood vessel further improvement of the mouthpiece, the baffle film made of e-PTFE or PET material.

[0010] 作为本发明血管缩口器的进一步改进,拉动所述支架的最内层的管口和所述支架的最外层的管口,所述支架成为单层管状。 [0010] The present invention reduced blood vessel further improvement mouthparts, pulling the stent innermost layer and said support nozzle orifice outermost layer, the single layer tubular stent becomes.

[0011] 作为本发明血管缩口器的进一步改进,所述支架的最内层管口边缘设有连接孔。 [0011] As the present invention is to further improve vascular contraction mouthpiece, said mouthpiece holder innermost edge provided with connecting holes.

[0012] 作为本发明血管缩口器的进一步改进,所述支架是用单根或者多根金属丝制成, 或者所述支架是用薄壁金属管雕刻而成。 [0012] The present invention reduced blood vessel further improvement of the mouthpiece, the stent is made of a single or a plurality of wires, or a thin-walled metal tube holder is carved.

[0013] 作为本发明血管缩口器的进一步改进,所述金属丝或金属管的材质为镍钛合金。 [0013] The present invention reduced blood vessel further improvement of the mouthpiece, the wire or metal pipe material is nitinol.

[0014] 作为本发明血管缩口器的进一步改进,位于远端处的最外层上的金属丝收拢固定在若干节点上,将所述每个节点的金属丝末端焊接成一个圆球,所述圆球均勻分布在最外层的管口处。 [0014] The present invention reduced blood vessel further improvement of the mouthpiece, the wire positioned at the outermost distal end is fixed to the retracted plurality of nodes, each node of the end of the wire is welded into a ball, the said ball uniformly distributed in the outermost layer of the tube opening.

[0015] 以及,解决本发明的技术问题所采用的另一技术方案是:一种用于输送和释放血管缩口器的可控释放系统,包括拉索,鞘管,及推杆,在鞘管的近端和远端之间具有贯通的内腔,拉索和推杆都穿过所述鞘管的内腔,所述拉索、推杆和鞘管都可相对滑动,所述可控释放系统具有输送状态和释放状态,其特征在于:所述血管缩口器设有一近端,在所述输送状态,所述血管缩口器被拉直并处于所述鞘管内,所述拉索与所述血管缩口器的近端连接, 所述推杆的远端接触所述血管缩口器的近端;在所述释放状态,使推杆向鞘管远端滑动,先将所述血管缩口器的远端从鞘管中释放出来,通过推杆与鞘管的相对运动,控制血管缩口器被从鞘管中推出的长度和速度,直至血管缩口器的近端被释放出来,再将拉索从所述血管缩口器的近端脱开;所述可控释放系 [0015] and a further aspect of the present invention to solve the technical problem is employed: a method for controlled release delivery system and releasing blood vessel contraction mouthpiece, including cable, the sheath and the pusher, the sheath having a penetrating between the proximal and distal tube lumen, the pusher and the cable pass through the lumen of the sheath, the cable, push rod and sheath can be slidable relative to said controllable release delivery system having a state and a release state, wherein: said mouthpiece is provided with a proximal end of reduced blood vessel, in the delivery state, the blood vessel is reduced and the mouthpiece straightened within said sheath, said cable the proximal end of the vascular compression of the mouthpiece is connected to the distal end of the pusher contacting the proximal end of the vascular compression of the mouthpiece; in the released state, the push rod is slid to the distal end of the sheath, the first condensing distal vessel is released from the mouthpiece out of the sheath, by relative movement of the push rod and the sheath, and controls the blood vessel contraction mouthpiece is pushed from the sheath in the length and speed, until the proximal vessel contraction mouthpiece is released out, then the proximal end of the cable from the vessel mouthpiece condensing disengaged; controlled release system of the 还具有回收状态,在所述血管缩口器完全脱离鞘管之前,绷紧拉索往鞘管的近端回拉,将缩口器收缩并撤回鞘管内。 Further comprising recovering the state before the blood vessel contraction mouthpiece completely out of the sheath, the proximal end to the tension cable sheath pull back, will shrink and withdraw mouthparts shrink the sheath.

[0016] 与现有技术相比,本发明具备以下优点:1、本发明血管缩口器是一种可收缩的多层折叠的结构,可以通过外力将其伸展开,并且收缩到输送鞘管中,这种结构的设计可以将其收缩到直径比较小的鞘管中,减小了对患者血管的创伤。 [0016] Compared with the prior art, the present invention has the following advantages: 1. The present invention mouthparts reduction vessel is a collapsible folding multilayer structure, it may be stretched by an external force, and is retracted into the delivery sheath , the design of this arrangement may be contracted to a relatively small diameter of the sheath tube is reduced trauma to the patient's blood vessels. 2、本发明血管缩口器的最内层和最外层都是圆管,内外层之间的过渡段是圆锥管或波纹管,过渡段紧贴内外层的管壁,而且是整体网状结构,提高了力学稳定性,能提供足够强的支撑力,既有利于固定瓣膜,也能防止缩口器移位。 Transition between the two, the present invention is vascular contraction mouthpiece innermost layer and the outermost layer are tube, the inner and outer wall is conical tube or bellows, the transition section close to the inner and outer layers, and the overall net structure, improved mechanical stability, can provide a sufficiently strong supporting force, both for fixing the valve, the mouthpiece can be prevented from condensing displacement. 3、本发明所述缩口器的两端固定有阻流膜,能防止血液从瓣膜周边泄露。 3, both ends of the present invention is the reduction of the mouthpiece is fixed baffle film can be prevented from leaking from the valve peripheral blood. 4、本发明的可控释放系统可以同肺动脉介入瓣技术结合应用,实现了利用导管介入的方式修复法氏四联症患者一期手术后的肺动脉瓣,避免了对患者的二次外科修复,减小了对病人的创伤,缩短了手术时间,简化了手术操作。 4, a controlled release system of the present invention may be involved with the application of the pulmonary valve technologies, using a catheter to achieve a repair method intrusively Fallot after surgery in patients with pulmonary valve a to avoid secondary surgical repair of a patient, reduced patient trauma, shorten the operation time, simplifying the surgical procedure. 5、本发明中的血管缩口器在患者体内实现了可控释放,可进行反复定位。 5, in the present invention is a blood vessel in a patient mouthpiece reduction achieved controlled release, can be repeatedly positioned.

附图说明 BRIEF DESCRIPTION

[0017] 下面将结合附图及实施例对本发明作进一步说明,附图中: [0017] The accompanying drawings and the following embodiments of the present invention is further illustrated drawings in which:

[0018] 图1是本发明血管缩口器第一实施方式的示意图; [0018] FIG. 1 is a schematic view of the mouthpiece of the first embodiment of the present invention reduced a blood vessel;

[0019] 图2是本发明血管缩口器第一实施方式中的支架的示意图;[0020] 图3是本发明血管缩口器第一实施方式中的阻流膜的示意图; [0019] FIG. 2 is a schematic view of the vascular stent of the present invention reduced the mouthpiece of a first embodiment; [0020] FIG. 3 is a schematic flow blocking film vascular contraction mouthpiece embodiment of the present invention in a first embodiment;

[0021] 图4是本发明血管缩口器第一实施方式中的拉线的示意图; [0021] FIG. 4 is a schematic view of the mouthpiece of the wire in the first embodiment of the present invention, a blood vessel contraction;

[0022] 图5是本发明血管缩口器第一实施方式中的支架在编织之后与热处理定形之前的示意图; [0022] FIG. 5 is a schematic view of the present invention before heat treatment of vascular contraction shaped manner stent after braiding a first embodiment of the mouthpiece;

[0023] 图6是本发明血管缩口器的可控释放系统的示意图; [0023] FIG. 6 is a schematic view of the vascular system of controlled release of the compression of the mouthpiece of the present invention;

[0024] 图7是本发明血管缩口器第二实施方式的示意图; [0024] FIG. 7 is a schematic diagram of a second embodiment of the mouthpiece of the present invention, a blood vessel contraction;

[0025] 图8是是本发明血管缩口器第二实施方式中的支架在编织之后与热处理定形之前的示意图; [0025] FIG. 8 is a schematic view of the invention is the reduction vessel before the heat treatment after knitting a shaped mouthpiece in the second embodiment of the stent;

[0026] 图9是本发明血管缩口器第三实施方式的示意图; [0026] FIG. 9 is a schematic view of the mouthpiece of the present invention reduced a blood vessel of the third embodiment;

[0027] 图10是本发明血管缩口器第四实施方式的示意图。 [0027] FIG. 10 is a schematic view of the mouthpiece of the present invention reduce vascular fourth embodiment.

具体实施方式 detailed description

[0028] 为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本发明进行进一步详细说明。 [0028] To make the objectives, technical solutions and advantages of the present invention will become more apparent hereinafter in conjunction with the accompanying drawings and embodiments of the present invention will be further described in detail. 应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。 It should be understood that the specific embodiments described herein are only intended to illustrate the present invention and are not intended to limit the present invention.

[0029] 本发明中的血管缩口器的支架可以用不锈钢、钴铬合金等金属材料制成,最好是采用超弹性形状记忆合金材料镍钛制成。 [0029] In the present invention, vascular stents can be reduced mouthparts a metal material of stainless steel, cobalt-chromium alloy or the like, preferably using a superelastic shape memory alloy made of nickel-titanium material. 支架可用单根或者多根镍钛丝编织而成,也可用镍钛管激光雕刻而成。 Available single bracket or a plurality of nickel-titanium wire woven nitinol tube may also be made for laser engraving. 以镍钛合金为例,制作该金属支架的基本过程如下:首先,用镍钛丝或者镍钛管制作成闭环网状的直管形支架,然后再利用模具将该直管形支架热处理定形成一个多层折叠的支架。 In nickel-titanium alloy, for example, the basic process of making the metal frame as follows: First, a closed loop made of nickel-titanium wire mesh or a straight tubular nitinol stent control, using a mold and then the straight-tube heat set into a holder the multilayer folded stent. 镍钛合金材料因为其自身的超弹性形状记忆特性,可保证该支架可通过外力将其伸展开,并收缩到一个比最内层直径还要小的输送鞘管中,并且从输送鞘管中释放后还能自动回复到初始的多层折叠状态。 Nitinol material itself because of its superelastic shape memory properties can be guaranteed by an external force the stent can be stretched and contracted to a diameter smaller than the innermost layer of the delivery sheath, and the sheath of the delivery after releasing also automatically returned to the original multi-layer folded state.

[0030] 下面将结合附图和多个具体实施例对本发明做进一步详细说明。 [0030] The following specific examples will be described in further detail in conjunction with the accompanying drawings of the present invention and a plurality.

[0031] 实施例一 [0031] Example a

[0032] 如图1至图4所示,本发明血管缩口器实施例一是一个可控释放缩口器,其由以下几个部分构成:三层折叠的镍钛丝编织而成的支架100,如图2所示;阻流膜200,如图3所示;以及可选的拉线300,如图4所示。 [0032] As shown in FIG. 1 to FIG vascular contraction mouthpiece of the present invention Example 4 First, a controlled release condensing mouthpiece, which consists of the following parts: triple folding woven nitinol wire stent 100, shown in Figure 2; flow blocking film 200, as shown in FIG. 3; and optionally wire 300, as shown in FIG. 本实施例一中的支架100采用三十根镍钛丝编织定形而成,具有连续的网格状表面。 A stent embodiment 100 of the present embodiment uses thirty amorphous nickel-titanium wire braid is made with a continuous grid-like surface. 该支架100有一个近端1和一个远端2,该支架100的远端2的边缘位于支架100的最外层3,该支架100的近端1的边缘位于该支架100的最内层5。 The stent 100 has a proximal end and a distal end 1 2, the distal end of the stent 100 is located at the outermost edge 2 3 of the stent 100, the proximal end of the stent 100 is located at the edge of an innermost layer 5 of the holder 100 . 在近端1的边缘处有镍钛丝编织形成的连接孔101,都可在外力作用下变形,而且都是闭合的。 A connection hole 101 formed in the nickel titanium wire knitting, be deformed by an external force, and are closed at the edge of the proximal end 1. 该连接孔101围绕支架100的轴线分布在三个不同的圆周上,该连接孔101所处的圆周之间的轴向距离与支架网格尺寸相当,最靠外的连接孔101最适合用于可控释放。 The connection hole 101 around the axis of the connection hole 101 of bracket 100 distributed on three different circumferences, the axial distance between the mesh size of the stent 101 circumference of the connecting hole is located rather, the outermost most suitable for controlled release. 该支架100的远端2的镍钛丝末端成对编织在一起,每一对镍钛丝的末端焊接成小圆球,以防止支架远端散开,避免损伤人体组织。 The distal end 100 of the braided stent nickel-titanium wire end 2 together in pairs, each pair of nickel-titanium wire tip into small solder balls, the distal end of the stent to prevent the spread, prevent tissue damage. 该支架100的最外层3和过渡段4通过近端的第一端6连接,过渡段4和该支架100的最内层5通过远端的第二端7连接。 The outermost layer 100 of the bracket 3 and 4 are connected by a first transition section proximal end 6, the transition section of the innermost layer 54 and the second bracket 100 is connected by a distal end 7. 该最外层3和最内层5为直管形状,该过渡段4近似圆锥管。 The outermost layer 3 and the innermost layer 5 of a straight tube shape, the transition section 4 is approximately conical tube. 该最内层5紧贴过渡段4的近端,最外层3紧贴过渡段4的远端,它们通过近端的第一端6和远端的第二端7构成一个整体,这种结构可以增强径向支撑力,更好地固定缩口器和瓣膜。 The innermost layer 5 close to the proximal end of the transition section 4, the outermost layer 3 close to the distal end of the transition section 4, which constitutes a whole through the first end 6 and a second end distal the proximal end 7, which structure can enhance radial strength, to better secure the mouthpiece and the valve condensation. 为了制作如图2所示的三层折叠支架100, 可先用三十根镍钛丝编织成管状网,再定形成如图5所示的直管形状支架,然后利用模具 To triple folding stand 100 as shown in FIG. 2 production, first with thirty tubular nitinol wires woven into a mesh, and then set to form a straight tubular shape of the stent as shown in FIG. 5, and then using the mold

5热处理定形为三层折叠的由镍钛丝编织的支架100。 5 is a three-shaped heat folded braided nitinol wire stent 100. 利用现有技术中的编织工艺,还可用单根镍钛丝编织支架,不需焊接支架远端的镍钛丝,热处理过程是相同的。 Knitting process of the prior art, but also with a single nickel-titanium wire braided stent, the stent distal end without welding nickel-titanium wire, the heat treatment process is the same.

[0033] 在折叠的支架100上覆阻流膜,将一组阻流膜200通过缝线固定在如图1所示支架100上的位置。 [0033] The coating film on the folding flow blocking bracket 100, a set of flow blocking film 200 by a suture secured in place on the bracket 100 as shown in FIG. 可用两片环状阻流膜200构成一组,覆盖在支架100上的阻流膜200的截面形状如图3所示。 Available two annular baffle film 200 constituting a set, cover the sectional shape of the flow blocking film 100 to the holder 200 as shown in FIG. 两片阻流膜200被分别包覆在近端的呈环状的第一端6内侧和远端的第二端7外侧,可阻止血流从该支架100的最外层3和最内层5之间流过。 The first end 6 second end 7 and a distal end inside the outer ring-shaped two flow blocking film 200 is coated at the proximal end, respectively, and prevents blood from the outermost layer of the stent 100 and the innermost layer 3 between 5 flows. 该第一端6的内径小于第二端7的外径(该第一端6的内径是指第一端6离管状最内层5的轴线的最短距离,同理,该第二端7的外径是指第二端7离管状最内层5的轴线的最大距离)。 The first end of the inner diameter smaller than the diameter of the second end 6 of 7 (inner diameter of the first end 6 of the first end 6 refers to the minimum distance from the axis of the tubular innermost layer 5, Similarly, the second end 7 the outer diameter is the maximum distance from the axis of the tubular innermost layer 5 of the second end 7). 为了把支架100置入输送鞘管内,先要把支架100拉伸成直管形,这时两片阻流膜200都仍然保持在该支架100内部,以保证整个支架100被顺利收缩进鞘管。 In order to transport the stent into the sheath 100, stent 100 should first stretched to a straight tube type, when two flow blocking film 200 are still held inside the holder 100, to ensure that the entire stent 100 is smoothly retracted into sheath . 本发明实施例中的阻流膜材料,采用具有良好生物相容性的材料,如PET、e-PTFE、或其衍生物等。 Baffle film material in the embodiment of the present invention, a material with good biocompatibility, such as PET, e-PTFE, or derivatives thereof. 图4所示的拉线300 可以用聚丙烯线,穿过支架100的近端1最外围的连接孔101,如图1所示。 FIG pull wire 300 shown in FIG. 4 may be polypropylene line, through the proximal stent 100 is connected to an outermost periphery of the hole 101, as shown in FIG. 根据医生操作的需要,拉线300可以是两端自由的,也可用如图4所示的闭合线。 The operation requires a doctor, pull wire 300 may be free at both ends, the closure line shown in FIG. 4 can also be used. 对于闭合的拉线300,可以再用一根拉索配合完成可控释放操作。 For the cable 300 is closed, then a cable can be controlled with the completion of the release operation.

[0034] 图6所示为本发明中的可控释放系统的主要部分,即血管缩口器所用的输送装置,由血管扩张器8、鞘芯9、拉索10、鞘管11、推杆12、鞘管手柄13、推杆手柄14组成。 The main part of this controlled release system of the invention shown in [0034] FIG 6, i.e., reduced vascular delivery device used in the mouthpiece, 8 by a vessel dilator, sheath-core 9, the cable 10, the sheath 11, the pusher 12, sheath handle 13, pusher 14 consisting of a handle. 血管扩张器8与鞘芯9连接在一起,推杆12在鞘管11的贯通的内腔里,鞘芯9和拉索10都从推杆12的内孔通过,鞘管手柄13上有锁紧装置16可将推杆12锁住,推杆手柄14上有锁紧装置17可将鞘芯9锁住。 8 is connected to the vessel dilator sheath core 9 together, the push rod 12 through the lumen 11 of the sheath, the sheath and the core 9 from the cable 10 through the bore of the push rod 12, the sheath 13 locks on handle the tightening device 16 may lock the push rod 12, a locking means 17 may be sheath-core pusher handle 14 locks the upper 9. 拉索10可直接穿过缩口器最内层5近端的连接孔101。 Cable 10 may be directly connected through the hole 101 of the innermost layer 5 proximal contraction mouthpiece. 图4所示缩口器上的闭合拉线300可与拉索10连接在一起,通过拉力将缩口器收缩到外鞘管11中,缩口器的近端1与推杆12的远端接触,释放时通过推杆12的推力将其释放。 Figure 4 shows the closure cable 300 may be connected to the mouthpiece shrink cable 10 together, by pulling the mouthpiece retracted into the reduced outer sheath 11, the proximal end of a shrink mouthparts into contact with the distal end of the pushrod 12 when released by the push rod 12 of the thrust their release.

[0035] 在输送状态,拉索10远端顺次穿过最靠近缩口器近端1管口边缘的若干连接孔101,缩口器被拉成直管并被压缩收入鞘管11内腔的远端附近,推杆12远端顶住缩口器近端1。 [0035] In the delivery state, the distal end of the cable 10 is connected sequentially through a plurality of holes 101 nearest the proximal end of the contraction mouthpiece of an opening edge, contraction pulled into the mouthpiece 11 and is compressed straight tube lumen sheath revenue near the distal end, the distal end of the push rod 12 against the proximal end of the mouthpiece 1 compression. 当鞘管11远端到达人体内指定部位时,首先是缩口器远端被从输送鞘管11中释放出来,近端最后被释放出来。 When the distal end of the sheath 11 reaches the designated body portion, a first condensing mouthpiece is released from the distal end of the delivery sheath 11, the proximal end is finally released. 通过拉索10、推杆12和鞘管11的相对运动,可精确控制缩口器的释放长度和速度。 Through the cable 10, the relative movement of the push rod 12 and sheath 11 can be precisely controlled and the release rate reduced length of the mouthpiece. 令推杆12相对鞘管11向远端滑动一定长度,可将相应长度的一段缩口器推出鞘管11并膨胀恢复原状。 So that the push rod 12 slides relative to the sheath 11 distally a certain length, the length of the condensing section corresponding mouthpiece Release sheath 11 may be expanded and restitution. 在缩口器全部离开鞘管11之前,绷紧拉索10往近端回拉,可将缩口器撤回鞘管11内,再向远端滑动推杆12又可重新释放。 Before leaving the sheath 11 in the entire condensing mouthpiece, the proximal end of tension cable 10 to pull back the mouthpiece can be reduced to withdraw the sheath 11, the distal end of the slide ram 12 in turn again released again. 反复操作可将缩口器释放到所需位置并恢复到多层折叠状态,最后可将拉索10从连接孔101中抽出。 Repeated operation can be reduced to the desired position and releasing the mouthpiece restored to the multilayer folded state, and finally the cable 10 can be withdrawn from the connecting hole 101. 如果缩口器按以上方法设置拉线300,则拉索10不必穿过连接口101,只要穿过拉线300就能实现同样的功能。 If the contraction wire mouthpiece 300 is provided by the above method, the cable 10 does not pass through the connection port 101, through cable 300 can be achieved as long as the same function.

[0036] 本实施例一中的血管缩口器及可控释放系统可按如下基本步骤制作和组装: [0036] In one embodiment of the present embodiment condensing vessel mouthparts and controlled release systems can be assembled and produced the following basic steps:

[0037] 采用镍钛丝编织,通过热处理定形,制作一条直管型的网状支架,支架具有一近端和一远端,近端连接点在轴向上分为三层,每个连接点处设置一个连接孔; [0037] The nickel-titanium wire knitting, by setting the heat treatment, making a straight tube type mesh stent, the stent having a proximal end and a distal end, a proximal end connection points are divided into three layers in the axial direction, each connection a connector provided at the aperture;

[0038] 利用模具进行热处理,将该直管型的网状支架定形成三层折叠的支架,其最外层和最内层都为直管形,最外层和最内层之间有连续的过渡段,最外层开口朝支架远端,最外层与过渡段通过近端的第一端连接,最内层开口朝支架近端,最内层与过渡段通过远端的第二端连接; [0038] The heat treatment is performed using a mold, the straight tube type stent shaped as a three-layer folded mesh stent, the outermost and innermost layer are the straight tube, there are continuous between the outermost layer and the innermost layer the transition section, the outermost layer of the stent toward the distal end opening, and the outermost end of the transition section are connected by a first proximal end, the proximal end of the stent is open to the innermost layer, the innermost end of the transition section by a second distal end connection;

[0039] 制作缩口器的阻流膜支架,在该三层折叠支架的近端的第一端内侧和远端的第二端外侧分别缝合一片环形的阻流膜; [0039] Production condensing baffle mouthpiece stent-graft, a second end outside the first end of the inner proximal end and a distal end of the suture are three folding stand an annular flow blocking film;

[0040] 将拉线穿过该阻流膜支架最内层在支架近端边缘的一组连接孔; [0040] The wire passes through the choke the connection hole set in the innermost stent-graft proximal edge of the stent;

[0041] 组装一套由血管扩张器、鞘管、推杆、鞘芯、拉索、鞘管手柄、推杆手柄组成的输送装置; [0041] Assembly of a vessel dilator, sheath, plunger, sheath-core transfer device, cable, sheath handle, pusher grip thereof;

[0042] 将该缩口器收缩到该输送装置的鞘管中,组成可控释放系统。 [0042] The shrinkage of the sheath to shrink the mouthpiece of the delivery device, the composition of controlled release systems.

[0043] 实施例二 [0043] Second Embodiment

[0044] 如图7所示,本发明血管缩口器的第二实施例与血管缩口器的实施例一不同之处在于:图7所示的血管缩口器中金属支架18采用镍钛管激光雕刻而成。 [0044] 7, an embodiment of the present invention reduced a blood vessel to the second embodiment of the mouthpiece with a mouthpiece condensing vessels except that: the blood vessel shown in Figure 7 the mouthpiece reduced nickel titanium metal stent 18 carved laser tube. 首先利用镍钛管激光雕刻并定形成图8所示的直管形支架,支架18具有支架近端19和支架远端20,然后通过模具定形成图7所示三层折叠的支架,支架空间结构与图2所示的支架空间结构相同。 First, a nickel titanium tube laser engraving and shaped to FIG. 8 straight tube type stent, the stent having a proximal stent 18 and stent 19 distal end 20, and shaped to a folded triple shown a bracket 7 through the mold space same rack space configuration as shown in FIG. 2 structure. 在支架近端也设置连接孔,供拉线300或拉索10穿过,以实现血管缩口器的可控释放。 Also be provided in the proximal end of the stent connecting hole 300 for wire or cable 10 passes through, in order to achieve a controlled release of vascular contraction mouthpiece. 血管缩口器被完全释放后,其近端连接孔可与拉线300或拉索10解脱。 Vascular contraction mouthpiece is fully released, its proximal end is connected releasably with the hole 300 or the wire cable 10.

[0045] 实施例三 [0045] Example three

[0046] 如图9所示,本发明血管缩口器的第三实施例与实施例一的不同之处在于:图9所示的三层折叠支架具有波纹形的过渡段。 [0046] As shown in FIG. 9, a third embodiment of the present invention reduced a blood vessel with a mouthpiece embodiment differs from the embodiment in that a: triple folding stand shown in FIG 9 has a corrugated transition piece. 在热处理定形支架时,将模具表面做成波纹形,就可以实现。 When heat-setting the stent, made of a corrugated mold surface, can be achieved. 波纹形的过渡段的波谷21、23与支架最内层接触,波峰22、24与支架最外层接触,波谷21在过渡段的近端,波峰24在过渡段的远端。 21 and 23 in contact with the innermost troughs of the corrugated transition piece holder, the outermost layer contacting the stent peaks 22 and 24, the transition section at the proximal end, the distal end of the peak in the troughs 2124 of the transition section. 这种波纹形的过渡段,能够使支架最内层与最外层之间的支撑力更均勻,使缩口器的结构更稳定。 Such corrugated transition piece can be made between the brackets supporting force innermost layer and the outermost layer is more uniform, so that the structure is more stable shrinkage mouthpiece.

[0047] 实施例四 [0047] Fourth Embodiment

[0048] 如图10所示,本发明血管缩口器的第四实施例与实施例一的不同之处在于:图10 所示的三层折叠支架具有多层折叠的过渡段,进一步加强支架最内层与最外层之间的支撑力。 [0048] As shown in FIG 10, a fourth embodiment of the present invention, vascular compression of the mouthpiece is different from the embodiment of a: three folding stand shown in Figure 10 having a multilayer transition section folded, further reinforcing brace supporting force between the innermost layer and the outermost layer. 可根据血管缩口器的尺寸和力学要求,选择过渡段折叠的层数,一般可往复折叠三次或五次。 According to the size and mechanical requirements of vascular contraction mouthpiece choose fold level transition section, generally three or five reciprocation folded. 加上支架最内层和最外层,具有这种多层折叠过渡段的缩口器,就包含多层折叠支架(超过三层)。 Plus bracket innermost and outermost layer having such a multilayer transition section fold reduction mouthparts, contains multilayer folding stand (more than three). 多层折叠过渡段的内缘25、27、29与支架最内层接触,其外缘26、28、30与支架最外层接触,过渡段的内缘25在其近端,过渡段的外缘30在其远端。 Innermost layer contacting the inner edge of the bracket 25, 27 with the folded multilayer transition section, the outermost layer in contact with the outer edge 26,28 and the bracket, the outer edge of the transition section 25 at its proximal end, the transition section edge 30 at its distal end. 在进行支架热处理时,可分几次对过渡段进行定形,每次完成一个折叠层,并都使用相应的模具。 During the heat treatment the stent, can be divided into several segments amorphous transition, each time the completion of a flap, and use the corresponding mold. 例如,先将过渡段内缘29定形,然后对过渡段外缘28定形,再对过渡段内缘27定形,最后对过渡段外缘26定形,其他的定形步骤与实施例一相同。 For example, the first edge 29 shaped transition section, and an outer edge 28 shaped transition section, the transition section and then the shaped edge 27, the outer edge of the transition section 26 finally shaped, the other setting the same procedure as in Example a.

[0049] 本发明血管缩口器可通过鞘管介入输送的方式,放置于人体肺动脉瓣的位置。 [0049] The mouthpiece of the present invention can reduce vascular intervention by delivery sheath embodiment, the body is placed in the position of the pulmonary valve. 该血管缩口器包含一个具有阻流膜的支架,其支架由外层、内层和过渡段构成,其过渡段可以近似圆锥、波纹管或多层折叠,释放后支架外层会将人体原有肺动脉瓣扩张开,并与肺动脉壁接触,血流只能从支架内层的中间通过,以达到减小人体肺动脉瓣处的管腔直径的目的。 The condensation vessel comprises a mouthpiece holder having a flow blocking film, the stent is made of an outer layer, inner layer and a transition section, which can be approximated by a conical transition section, or multi-folded bellows, the outer layer will release the stent after the original human there pulmonary valve is pushed open, and in contact with the wall of the pulmonary artery, the blood flow only from the inner layer by the intermediate bracket, for the purpose of reducing the diameter of the lumen of the body at the pulmonary valve. 缩口器放置好后,可以接着通过介入的方式在支架内层放置一个肺动脉瓣膜。 Position the mouthpiece after reduction, may then be placed in a pulmonary valve inner stent through intervening manner. 缩口器能够提供足够的支撑力,防止瓣膜移位,避免血流从瓣膜外周渗漏。 Condensing the mouthpiece can provide adequate support to prevent displacement of the valve to prevent blood leaking from the outer periphery of the valve. 本发明解决了法氏四联症患者一期手术后不能通过介入的方式修复肺动脉瓣的问题。 The invention solves the law Fallot patients after a surgical intervention is not the way to fix the problem through the pulmonary valve. 使用本发明所述的缩口器,可以将介入肺动脉瓣技术引用到这类患者当中,这样可减小对患者的创伤,降低手术的风险性。 Using a condensing the mouthpiece of the present invention, reference will be involved in pulmonary art to which this patient, this would reduce the trauma to the patient and reduce the risk of surgery. 本发明的缩口器可控释放系统可以精确控制缩口器的释放长度和速度,使缩口器顺利到达所需位置并具有正常形态。 Condensing mouthpiece controlled release system of the present invention can precisely control the release rate and the length contraction mouthparts, the mouthparts reduced so smoothly in the desired position and having a normal morphology. 在缩口器完全释放之前,可将缩口器撤回,以便重新定位,极大地方便了医生操作。 Before fully releasing contraction mouthpiece, the mouthpiece can be reduced withdrawn to reposition, greatly facilitates the doctors to operate.

7[0050] 本发明与现有技术相比,同时具有以下优点:1、本发明中的可控释放的血管缩口器技术可以同肺动脉介入瓣技术结合应用,实现了利用导管介入的方式修复法氏四联症患者一期手术后的肺动脉瓣,避免了对患者的二次外科修复,减小了对病人的创伤,缩短了手术时间,简化了手术操作。 7 [0050] Compared with the prior art, also has the following advantages: 1, controlled release vessel of the present invention can be reduced mouthparts art technology with applications in interventional valve with the pulmonary artery, using a catheter to achieve the repair intrusively method Fallot after surgery in patients with pulmonary valve a to avoid secondary surgical repair of a patient, reducing patient trauma, shorten the operation time, simplifying the surgical procedure. 2、本发明中的血管缩口器在患者体内实现了可控释放,可进行反复定位。 2, in the present invention is a blood vessel in a patient mouthpiece reduction achieved controlled release, can be repeatedly positioned. 3、本发明中的缩口器是一种多层折叠的结构,可以通过外力将其伸展开,并且收缩到输送鞘管中,这种结构的设计可以将其收缩到直径比较小的鞘管中,减小了对患者血管的创伤。 3, in the present invention is a multilayer compression mouthpiece folded structure, may be stretched by an external force, and is retracted into the delivery sheath, the design of this arrangement may be contracted to its relatively small diameter of the sheath in reduced trauma to the patient's blood vessels. 4、本发明的血管缩口器的最内层和最外层都是圆管,内外层之间的过渡段是圆锥管或波纹管,过渡段紧贴内外层的管壁,而且是整体网状结构,提高了力学稳定性,能提供足够强的支撑力,既有利于固定瓣膜,也能防止缩口器移位。 4, the transition between the condensing vessel according to the invention the mouthpiece and the outermost layer is the innermost tube, the inner and outer layer is a conical tube or bellows, the wall of the transition section close to the inner and outer layers, and the overall network structure, improved mechanical stability, can provide a sufficiently strong supporting force, both for fixing the valve, the mouthpiece can be prevented from condensing displacement. 5、本发明的血管缩口器的两端固定阻流膜,能防止血液从瓣膜周边泄露。 5, the present invention is vascular contraction mouthpiece baffle film fixed at both ends, the valve can be prevented from leaking from the peripheral blood.

[0051] 以上所述仅为本发明的较佳实施例而已,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、等同替换和改进等,均应包含在本发明的保护范围之内。 [0051] The foregoing is only preferred embodiments of the present invention but are not intended 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 present within the scope of the invention.

Claims (10)

  1. 一种血管缩口器,其包括一个可收缩的多层的网状支架,所述支架有一近端和一远端,所述支架的最内层有一管口朝向所述支架的近端,所述支架的最外层设有一管口朝向所述支架的远端,所述最内层与最外层之间设有一过渡段,其特征在于:所述过渡段包括圆锥管结构、波纹管结构、多层折叠结构或者三种结构相互组合的结构,所述过渡段设有靠近所述支架的近端的第一端和靠近所述支架的远端的第二端,所述第一端靠近所述支架的最内层,所述第二端靠近所述支架的最外层,所述第一端的内径小于第二端的外径。 An intravascular reduced mouthparts, comprising a collapsible multilayer mesh stent, the stent having a proximal end and a distal end, the innermost layer of the stent has an opening towards the proximal end of the stent, the said outermost distal end of the stent is provided with an opening facing the bracket, the most inner layer between the outermost layer provided with a transition section, wherein: said transition portion comprises a conical tube structure, the bellows structure , folding the multilayer structure or a structure of three structurally combined with each other, the transition from the first end and a second end proximate the distal end of the stent section is provided near the proximal end of the stent, the first end adjacent innermost layer of the bracket, the second bracket end adjacent to the outermost layer, an inner diameter smaller than the outer diameter of the first end to the second end.
  2. 2.如权利要求1所述的血管缩口器,其特征在于:进一步包括设置在所述过渡段上的阻流膜,设置所述阻流膜的区域包括所述过渡段的第一端和第二端。 2. A vessel according to claim 1 contraction mouthpiece, characterized by: further comprising a flow blocking film disposed on the transition section, the area of ​​flow blocking film is provided comprising a first end of the transition section and The second end.
  3. 3.如权利要求2所述的血管缩口器,其特征在于:所述阻流膜的材质为PET或e-PTFE 材料。 The vessel of claim 2 shrink mouthpiece, characterized in that: said flow blocking film is made of e-PTFE or PET material.
  4. 4.如权利要求1所述的血管缩口器,其特征在于:拉动所述支架的最内层的管口和所述支架的最外层的管口,所述支架成为单层管状。 4. A vessel according to claim 1 contraction mouthpiece, characterized in that: the innermost orifice pull the bracket and the outermost layer of said nozzle holder, said single tubular stent becomes.
  5. 5.如权利要求4所述的血管缩口器,其特征在于:所述支架的最内层管口边缘设有连接孔。 5. A vessel as claimed in claim 4, wherein the mouthpiece shrink, characterized in that: said nozzle holder innermost edge provided with connecting holes.
  6. 6.如权利要求1所述的血管缩口器,其特征在于:所述支架是用单根或者多根金属丝编织而成。 The vessel as claimed in claim 1, condensing the mouthpiece, wherein: said stent is a woven single or a plurality of wires.
  7. 7.如权利要求1所述的血管缩口器,其特征在于:所述支架是用薄壁金属管雕刻而成。 7. A vessel according to claim 1 contraction mouthpiece, wherein: said stent is a thin-walled metal tube carved.
  8. 8.如权利要求6或7所述的血管缩口器,其特征在于:所述金属丝或金属管的材质为镍钛合金。 8. The vessel of claim 6 or claim 7 condensing mouthpiece, wherein: a material of the wire or tube is a nickel-titanium alloy.
  9. 9.如权利要求6所述的血管缩口器,其特征在于:位于远端处的最外层上的金属丝收拢固定在若干节点上,将所述每个节点的金属丝末端焊接成一个圆球,所述圆球均勻分布在最外层的管口处。 9. A vessel according to claim 6 contraction mouthpiece, characterized in that: the outermost layer on the wire at the distal end is fixed to the retracted plurality of nodes, each node of the end of the wire into a weld ball, the ball evenly distributed in the outermost layer of the tube opening.
  10. 10. 一种用于输送和释放权利要求1所述的血管缩口器的可控释放系统,包括拉索, 鞘管,及推杆,在鞘管的近端和远端之间具有贯通的内腔,拉索和推杆都穿过所述鞘管的内腔,所述拉索、推杆和鞘管都可相对滑动,所述可控释放系统具有输送状态和释放状态,其特征在于:所述血管缩口器设有一近端,在所述输送状态,所述血管缩口器被拉直并处于所述鞘管内,所述拉索与所述血管缩口器的近端连接,所述推杆的远端接触所述血管缩口器的近端;在所述释放状态,使推杆向鞘管远端滑动,先将所述血管缩口器的远端从鞘管中释放出来,通过推杆与鞘管的相对运动,控制血管缩口器被从鞘管中推出的长度和速度,直至血管缩口器的近端被释放出来,再将拉索从所述血管缩口器的近端脱开;所述可控释放系统还具有回收状态,在所述血管缩口器完全 10. A controlled release system for delivery and release as claimed in claim 1, the reduction vessel of the mouthparts, including cable, sheath, and the push rod, between the proximal and distal ends of the sheath having a through lumen, the pusher and the cable pass through the lumen of the sheath, the cable, push rod and sheath can be slidable relative to, the controlled release delivery system having a state and a release state, wherein : condensing the vessel is provided with a proximal end of the mouthpiece, in the delivery state, the blood vessel is reduced and the mouthpiece straightened within the sheath, the proximal end of the cable is connected to the blood vessel contraction mouthpiece, the push rod contacts the distal end of the proximal end of the vascular compression of the mouthpiece; in the released state, the push rod is slid to the distal end of the sheath, the distal end of the first condensing vessel is released from the mouthpiece of the sheath out by relative movement of the sheath and the pusher, a control vascular contraction mouthpiece is pushed from the sheath in the length and speed, reduced blood vessel until the proximal end of the mouthpiece is released, then the cable from the blood vessel constriction proximal end of disengagement; controlled release system also has the recovery state in the blood vessel is completely reduced mouthparts 离鞘管之前,绷紧拉索往鞘管的近端回拉,将缩口器收缩并撤回鞘管内。 Before away sheath, the cable tension to the proximal end of the sheath pull back, will shrink and withdraw mouthparts shrink the sheath.
CN 201010521767 2010-10-27 2010-10-27 Blood vessel necking device and controlled release system CN101961274A (en)

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CN102961199A (en) * 2012-11-30 2013-03-13 宁波健世生物科技有限公司 Anti-displacement pulmonary valve stent

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CN101247773A (en) * 2005-05-27 2008-08-20 心叶科技公司 Stentless support structure
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