CN100594015C - Rack valve with tongulate structure and its rack weaving process - Google Patents
Rack valve with tongulate structure and its rack weaving process Download PDFInfo
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Abstract
一种带舌状结构的支架瓣膜,包括内层支架体、至少一个外层舌状结构、瓣膜叶、密封膜、密封环、柔性联结环和不透X线标志。三个外层舌状结构沿内层支架体的径向均匀转角分配,瓣膜叶为三片,三片瓣膜叶分别与三个外层舌状结构相对应。支架瓣膜在植入时,内层支架体和外层舌状结构分别与输放装置上独立的支架拉线-锁丝系统配合,外层舌状结构可先于内层支架体单独扩张。一种带舌状结构的支架的编织方法,由弹性金属线材沿支架外轮廓螺旋前进编织而成。本发明的支架瓣膜形状、结构和功能更优化,其外层舌状结构有利于支架瓣膜轴向和旋转方向的准确定位和固定。本发明的编织方法简单科学,只用一根单线来回螺旋缠绕,即可编织成一个复杂结构的支架。
A stent valve with a tongue-like structure, comprising an inner stent body, at least one outer tongue-like structure, valve leaflets, a sealing membrane, a sealing ring, a flexible coupling ring and radiopaque markers. The three outer tongue-like structures are evenly distributed along the radial rotation angle of the inner stent body, and the valve leaflets are three, and the three valve leaflets correspond to the three outer tongue-like structures respectively. When the stent valve is implanted, the inner stent body and the outer tongue-like structure cooperate with the independent stent wire-locking system on the delivery device, and the outer tongue-like structure can be expanded independently of the inner stent body. A braiding method for a stent with a tongue-like structure, which is braided by elastic metal wires spirally advancing along the outer contour of the stent. The shape, structure and function of the stent valve of the present invention are more optimized, and the tongue-like structure of the outer layer is beneficial to the accurate positioning and fixing of the stent valve in the axial direction and the rotation direction. The weaving method of the present invention is simple and scientific, and only a single thread is used to spirally wind back and forth to weave a bracket with a complex structure.
Description
技术领域 technical field
本发明涉及一种人体组织的替代品及其制作方法,尤其涉及一种带舌状结构的支架瓣膜及其支架的编织方法。The invention relates to a human tissue substitute and a manufacturing method thereof, in particular to a stent valve with a tongue-like structure and a weaving method of the stent.
背景技术 Background technique
心脏是人体最重要的器官,心脏分为左右两部分,每一部分又包括心房和心室。左右心房和左右心室分别由房间隔和室间隔分开。在心脏内存在四个心脏瓣膜,即三尖瓣、肺动脉瓣、二尖瓣和主动脉瓣。在人体血液循环机构中,四个心脏瓣膜起着至关重要的作用。体循环机构的缺氧血液经腔静脉进入右心房,然后通过三尖瓣进入右心室,右心室收缩将血液通过肺动脉瓣压入肺循环机构,经过肺氧饱和后的血液经肺静脉回到左心房,再经二尖瓣到达左心室,左心室收缩将血液通过主动脉瓣排入主动脉而重返体循环机构。主动脉瓣膜下有左右冠状动脉开口。四个心脏瓣膜的结构保证了血液顺方向时瓣膜开放,逆方向时关闭,防止了血液返流而引起的心脏负担加重。但是,由于各种原因,可以导致心脏瓣膜的后天性损伤或病变,如风湿,动脉粥样硬化等。此外,先天性心脏病如法乐氏四联症,术后远期也可产生肺动脉瓣膜病变。瓣膜病变后表现为瓣膜功能逐渐丧失,如瓣膜关闭不全导致血液返流,瓣膜狭窄导致血液流通不畅,或关闭不全和狭窄二者兼并,以至加重心脏负担,导致心脏功能衰竭。对于心脏瓣膜的后天性损伤或病变,传统的治疗方法是开胸,心脏停跳后,在低温体外循环支持下,打开心脏进行病变瓣膜的外科修复或用人工心脏瓣膜置换。现有的人工心脏瓣膜分两大类:金属机械瓣膜和生物瓣膜。生物瓣膜由牛心包、牛颈静脉瓣、猪主动脉瓣等动物材料处理后制成。上述开心手术的方法,手术时间长,费用高,创伤大,风险大,金属机械瓣膜置换后病人需要长期抗凝治疗,生物瓣膜的材料寿命有限,通常需要再手术。The heart is the most important organ of the human body. The heart is divided into two parts, the left and the right, and each part includes the atrium and the ventricle. The left and right atria and right and left ventricles are separated by the atrial and ventricular septum, respectively. There are four heart valves in the heart, namely the tricuspid valve, pulmonary valve, mitral valve and aortic valve. In the human blood circulation mechanism, the four heart valves play a vital role. The hypoxic blood from the systemic circulation mechanism enters the right atrium through the vena cava, and then enters the right ventricle through the tricuspid valve. The contraction of the right ventricle pushes the blood into the pulmonary circulation mechanism through the pulmonary valve, and the oxygen-saturated blood returns to the left atrium through the pulmonary vein, and then Through the mitral valve to the left ventricle, the left ventricle contracts to expel blood through the aortic valve into the aorta and return to the systemic circulation. There are left and right coronary artery openings under the aortic valve. The structure of the four heart valves ensures that the valves open when the blood flows in the forward direction and close when the blood flows in the opposite direction, preventing the heart from increasing the burden caused by the backflow of blood. However, due to various reasons, acquired damage or disease of heart valves can be caused, such as rheumatism, atherosclerosis, etc. In addition, congenital heart disease such as tetralogy of Fallot can also cause pulmonary valve disease in the long term after surgery. After valvular disease, the valve function is gradually lost, such as valvular insufficiency leading to blood regurgitation, valvular stenosis leading to poor blood flow, or both insufficiency and stenosis, which will increase the burden on the heart and lead to heart failure. For the acquired damage or disease of the heart valve, the traditional treatment method is to open the chest, and after the heart stops beating, the heart is opened to perform surgical repair of the diseased valve or replace it with an artificial heart valve under the support of hypothermic extracorporeal circulation. The existing artificial heart valves are divided into two categories: metal mechanical valves and biological valves. Biological valves are made from processed animal materials such as bovine pericardium, bovine jugular valve, and porcine aortic valve. The above-mentioned open-heart surgery method has long operation time, high cost, large trauma, and high risk. After metal mechanical valve replacement, the patient needs long-term anticoagulant treatment, and the material life of the biological valve is limited, and reoperation is usually required.
为了解决上述开心手术治疗心脏瓣膜存在的问题,现在已有人尝试不作开心手术,而采用经皮介入方法或微创手术输放人工心脏瓣膜。现有技术的人工心脏瓣膜有二种:In order to solve the above-mentioned problems of open-heart surgery for the treatment of heart valves, some people try not to perform open-heart surgery, but use percutaneous intervention or minimally invasive surgery to deliver artificial heart valves. The artificial heart valve of prior art has two kinds:
1、球囊扩张型1. Balloon-expandable
这种球囊扩张型人工心脏瓣膜为生物瓣膜,其介入方法是在一个可塑性变形的支架上分别固定生物瓣膜,通过径向压缩在一个球囊上后直径变小,经皮输放,然后给球囊加压使支架扩张固定,达到工作状态。This balloon-expandable artificial heart valve is a biological valve. The intervention method is to respectively fix the biological valve on a plastically deformable stent, radially compress it on a balloon, and then reduce the diameter, deliver it percutaneously, and then give it to the patient. The balloon is pressurized to expand and fix the stent to reach the working state.
球囊扩张型人工瓣膜存在的缺点和问题是:其直径由球囊直径所决定,如果人工瓣膜的直径一开始没选择好,或某些生理变化后,如自然生长、病理性血管扩张等,自然瓣膜的口径大小可能增大,而人工瓣膜的口径不能适应性增大,人工瓣膜有松动或滑脱的危险,只能进行二次球囊再扩张。The disadvantages and problems of the balloon-expandable artificial valve are: its diameter is determined by the diameter of the balloon. If the diameter of the artificial valve is not selected at the beginning, or after some physiological changes, such as natural growth, pathological vascular expansion, etc., The caliber of the natural valve may increase, but the caliber of the artificial valve cannot be adaptively increased, and the artificial valve may loosen or slip off, so only secondary balloon re-expansion can be performed.
2、自扩张型2. Self-expanding
这种人工瓣膜设有一个弹性变形支架,径向压缩后可自行扩张。This prosthetic valve features an elastically deformable stent that expands on its own after being radially compressed.
现有技术的自扩张型人工瓣膜存在的缺点和问题是:自扩张型人工心脏瓣膜与鞘管间摩擦力大,影响人工瓣膜准确释放。The disadvantages and problems of the self-expandable artificial valve in the prior art are: the frictional force between the self-expandable artificial heart valve and the sheath tube is large, which affects the accurate release of the artificial valve.
上述球囊扩张型和自扩张型人工心脏瓣膜存在的共同缺点和问题是:The common shortcoming and the problem that above-mentioned balloon expansion type and self-expanding artificial heart valve exist are:
1、现有的人工支架瓣膜在径向压缩下较硬,弯曲性差,经过主动脉弓不容易,不能对准自然主动脉瓣膜口。1. The existing artificial stent valve is relatively hard under radial compression, has poor flexibility, is not easy to pass through the aortic arch, and cannot be aligned with the natural aortic valve orifice.
2、即便在x光透视帮助下,人工支架瓣膜的轴向上下游定位也因对解剖位置的判断不准和血流冲击下的人工瓣膜不稳定而变得不容易。人工主动脉瓣膜如果位置偏上游可影响二尖瓣,如果位置偏下游可堵阻冠状动脉开口。2. Even with the help of X-ray fluoroscopy, the axial upstream and downstream positioning of the artificial stent valve becomes difficult due to the inaccurate judgment of the anatomical position and the instability of the artificial valve under the impact of blood flow. A prosthetic aortic valve can affect the mitral valve if it is placed upstream, and it can block the opening of the coronary arteries if it is positioned downstream.
3、主动脉瓣人工支架瓣膜的旋转方向定位没能解决,人工主动脉瓣膜如果旋转位置不对可堵阻冠状动脉开口。3. The positioning of the rotation direction of the artificial aortic valve stent valve has not been solved. If the rotation position of the artificial aortic valve is wrong, it may block the coronary artery opening.
4、在释放过程中,支架瓣膜逐渐半扩张到全扩张,所需时间超过一个心跳周期。扩张的支架瓣膜会阻碍血流,支架瓣膜也可因血流冲击而使其位置改变。特别是球囊扩张型人工支架瓣膜在球囊扩张过程中完全阻断血流。4. During the release process, the stent valve gradually expands from half to full expansion, and the required time exceeds one heartbeat cycle. The expanded stent valve can obstruct blood flow, and the stent valve can also change its position due to the impact of blood flow. In particular, balloon-expandable prosthetic stent-valves completely block blood flow during balloon expansion.
5、释放扩张后的支架瓣膜的固定也存在以下问题:5. There are also the following problems in the fixation of the stent valve after release and expansion:
a)收缩期和舒张期血流冲击会使固定不好的人工支架瓣膜移动。a) The impact of blood flow during systole and diastole will move the poorly fixed artificial stent valve.
b)有些主动脉瓣关闭不全的病人其主动脉根部术前已有病理性扩张,需要很大的支架瓣膜才能与其吻合固定。b) Some patients with aortic valve insufficiency have pathological expansion of the aortic root before surgery, and a large stent valve is needed to anastomose and fix it.
c)有些病人在人工支架瓣膜植入后局部会有解剖性变化,如扩张,使不能相应变化的支架瓣膜失去有效固定。c) Some patients will have local anatomical changes after the artificial stent valve is implanted, such as expansion, so that the stent valve that cannot be changed accordingly will lose effective fixation.
6、扩张固定后的人工支架瓣膜在很多情况下有瓣周漏(Para valvularleaks),即血液从支架瓣膜和血管壁之间漏过。6. In many cases, the artificial stent valve after expansion and fixation has paravalvular leaks (Para valvular leaks), that is, blood leaks between the stent valve and the vessel wall.
7、瓣膜叶开关中如果接触到金属支架,会造成瓣膜叶磨损。7. If the metal stent is in contact with the valve leaflet switch, the valve leaflet will be worn out.
8、如果为了固定好而采用大直径支架瓣膜,瓣叶联合点(Commissure)会承受很大应力,造成瓣膜叶联合点撕损。8. If a large-diameter stent valve is used for fixation, the commissure of the valve leaflets will bear a lot of stress, resulting in tearing of the commissure of the valve leaflets.
发明内容 Contents of the invention
本发明的目的,在于克服现有技术存在的上述问题,提供一种新型结构的带舌状结构的支架瓣膜及其支架的编织方法。The object of the present invention is to overcome the above-mentioned problems in the prior art, and provide a novel structure of a stent valve with a tongue-like structure and a braiding method for the stent.
本发明的目的是这样实现的:一种带舌状结构的支架瓣膜,包括一个可以径向变形的管形网状支架,该网状支架包括上游段、中段和下游段,网状支架各网线之间围成多个可变形单元,在网状支架的两端形成多个弧形线拐,在网状支架上设有多个封闭式线眼、多个柔性联结环和多个不透X线标志,在网状支架中段的内侧连接有瓣膜叶,在网状支架上游段的内侧和/或外侧面覆盖有密封膜,其特点是,所述的网状支架包括一个圆管形或圆管形带径向突出结构的内层支架体,在内层支架体的外侧连接有至少一个由网线围合而成的舌状结构,外层舌状结构优选为三个,三个外层舌状结构沿内层支架体的径向均匀转角分配,各舌状结构与内层支架体在下游段或下游段与中段的交界处相连形成固定缘,并从固定缘开始向上游段延伸至上游段与中段的交界处形成游离缘;所述的瓣膜叶为三片,三片瓣膜叶以120度转角分配。The object of the present invention is achieved in this way: a stent valve with a tongue-like structure comprises a radially deformable tubular mesh stent, the mesh stent includes an upstream section, a middle section and a downstream section, and each mesh wire of the mesh stent A plurality of deformable units are surrounded, and a plurality of arc-shaped turns are formed at both ends of the mesh support, and a plurality of closed line eyes, a plurality of flexible coupling rings and a plurality of impermeable Xs are arranged on the mesh support. Line marks, valve leaflets are connected to the inner side of the middle section of the mesh stent, and the inner and/or outer sides of the upstream section of the mesh stent are covered with a sealing film. It is characterized in that the mesh stent includes a round tube or Tubular inner layer stent body with radially protruding structure, at least one tongue-like structure surrounded by mesh wires is connected to the outside of the inner layer stent body, preferably three outer layer tongue-like structures, three outer layer tongue-like structures The tongue-shaped structures are evenly distributed along the radial direction of the inner stent body, and each tongue-shaped structure is connected with the inner stent body at the downstream section or at the junction of the downstream section and the middle section to form a fixed edge, and extends from the fixed edge to the upstream section to the upstream A free edge is formed at the junction of the segment and the middle segment; the valve leaflets are three, and the three valve leaflets are distributed at a 120-degree rotation angle.
所述的外层舌状结构与内层径向突出结构在轴向和径向相对应,并设置在同一旋转角度上。The outer tongue-shaped structure is axially and radially corresponding to the inner radially protruding structure, and is arranged at the same rotation angle.
所述的瓣膜叶与舌状结构在轴向和径向相对应,并设置在同一轴向水平和径向旋转角度上。The valve leaflets are axially and radially corresponding to the tongue structure, and are arranged at the same axial level and radial rotation angle.
一种带舌状结构的支架的编织方法为:建立一个圆管形或圆管形带径向突出结构的内模,以弹性金属线材为编织线,编织要点如下:A weaving method for a stent with a tongue-like structure is as follows: a circular tube or a circular tube-shaped inner mold with a radially protruding structure is established, and an elastic metal wire is used as the braiding line. The key points of the braiding are as follows:
A、取编织线从接近支架的下游端口处开始,沿内模的外轮廓螺旋缠绕前进,到支架上游端口后再转向对称的相反方向沿内模的外轮廓螺旋缠绕前进,以此重复直到所有的可变形单元都已建立,编织成一个圆管形或圆管形带径向突出结构的内层支架体;A. Take the braided wire and start from the downstream port close to the stent, spirally wind along the outer contour of the inner mold, and then turn to the opposite direction of symmetry and spirally wind along the outer contour of the inner mold at the upstream port of the stent, and repeat until all All deformable units have been established and braided into a circular tube or a circular tube-shaped inner stent with a radially protruding structure;
B、由同一编织线从已编织好的内层支架体的下游端口的编织线起点开始重复编织,当编织到相当于绕支架约60度角后,让编织线脱离内层支架体,向外伸出绕成一个舌状结构后再转向对称的相反方向进入内层支架体重复编织,当编织到相当于绕支架约三分之一圆周后,再让编织线脱离内层支架体,向外伸出绕成一个舌状结构后再转向对称的相反方向进入内层支架体重复编织,直至编织成三个外层舌状结构,最后一段编织线进入内层支架体再重复编织到接近支架的下游端口;B. Repeat braiding from the same braided wire starting from the braided wire starting point at the downstream port of the braided inner stent body. After weaving to an angle equivalent to about 60 degrees around the stent, let the braided wire break away from the inner stent body and move outward Stretch out and wind into a tongue-like structure, then turn to the opposite direction of symmetry and enter the inner support body to repeat weaving. Stretch out and wind into a tongue-like structure, then turn to the opposite direction of symmetry and enter the inner support body to repeat weaving until three outer tongue-like structures are braided. downstream port;
C、在编织外层舌状结构时,控制编织线从内层支架体伸出的出点和进入内层支架体的进点在内层支架体的同一径向平面上,并控制出点与进点之间的距离相当于绕支架转约三分之一圆周,控制舌状结构的游离缘位于内层支架体的上游段与中段的交界处;C. When weaving the outer layer tongue-shaped structure, control the exit point of the braided wire protruding from the inner layer support body and the entry point entering the inner layer support body on the same radial plane of the inner layer support body, and control the exit point and the entry point of the inner layer support body The distance between the entry points is equivalent to about one-third of the circle around the stent, and the free edge of the control tongue structure is located at the junction of the upstream section and the middle section of the inner stent body;
D、位于内层支架体同一径向平面上的可变形单元数编织成3的倍数;D. The number of deformable units located on the same radial plane of the inner stent body is woven into a multiple of 3;
E、编织线的不同线段在相交时构成上下交错点,同一线段在其相邻交错点处的上下位置关系相反,位于同一交错点上的两线段之间可相互滑动;E. Different line segments of the braided line form an up and down stagger point when they intersect, and the upper and lower positions of the same line segment at its adjacent stagger point are opposite, and the two line segments on the same stagger point can slide mutually;
F、在编织内层支架体时,由编织线的不同线段围合成的可变形单元为四边形,编织线在支架的上游端口和下游端口转向时构成弧形线拐;F. When weaving the inner stent body, the deformable unit formed by different line segments of the braided wire is a quadrilateral, and the braided wire forms an arc-shaped turn when the upstream port and the downstream port of the stent turn;
G、在编织内层支架体时,根据需要在支架的两端或其它部位的某一交错点或拐点处将编织线转至少360度角构成封闭式线眼;G. When weaving the inner stent body, turn the braided wire at least 360 degrees at a cross point or inflection point at both ends of the stent or other parts to form a closed thread eye;
H、在编织内层支架体时,根据需要在支架的不同部位的编织线上套有不透X线标志,如在双线段或封闭式线眼的双线段上套有不透X线标志环。H. When weaving the inner stent body, cover the braiding wires of different parts of the stent with X-ray-opaque signs as required, such as covering X-ray-opaque marks on the double-line segment or the double-line segment of the closed line eye Logo ring.
所述的要点B中,编织线从内层支架体伸出后,还可以先绕一个至少360度的套环后再绕一个半环,套环的弧度与半环的弧度相当,套环的一部分与半环共同组成舌状结构。In the above-mentioned point B, after the braided wire protrudes from the inner support body, it can also be wound around a collar of at least 360 degrees and then a half-ring. The radian of the collar is equivalent to that of the half-ring. One part forms the tongue-like structure together with the half ring.
所述的套环可以为脱离内层支架体的全游离状态,也可以将其位于内层支架体下游段的部分编织到内层支架体内。The collar can be completely free from the inner stent, or it can be braided into the inner stent at the downstream end of the inner stent.
所述的要点B中,编织线在绕成一个舌状结构时,还可以在其弧顶绕至少360度角构成封闭式线眼,封闭式线眼的双线段上套有不透X线标志环。In the above point B, when the braided wire is wound into a tongue-like structure, it can also wind at least 360 degrees at the top of the arc to form a closed line eye, and the double line segment of the closed line eye is covered with an X-ray Logo ring.
所述的要点G中,封闭式线眼可以编织成与内层支架体或外层舌状结构在同一外轮廓曲面上,也可以编织成与内层支架体或外层舌状结构相垂直或成任意角度。In the above point G, the closed thread eye can be woven so that it is on the same outer contour surface as the inner stent or the outer tongue structure, or it can be woven so that it is perpendicular to the inner stent or the outer tongue structure or at any angle.
所述的舌状结构还可以由与内层支架体不同的编织线编织而成。The tongue structure can also be braided by different braided wires than the inner stent body.
本发明的带舌状结构的支架瓣膜由于采用了上述的技术方案,使之与现有技术相比,具有以下的优点和积极效果:The stent valve with tongue-shaped structure of the present invention has the following advantages and positive effects compared with the prior art due to the adoption of the above-mentioned technical solution:
1、形状、结构和功能更优化。1. The shape, structure and function are more optimized.
2、可变形支架既可与生物瓣膜配合也可与合成瓣膜配合。2. The deformable stent can cooperate with biological valves or synthetic valves.
3、增加了合成瓣膜的强度和寿命,不需抗凝,可望代替生物瓣膜。3. Increase the strength and lifespan of the synthetic valve, without anticoagulation, and it is expected to replace the biological valve.
4、支架瓣膜可径向压缩,在介入装置帮助下准确输送到位,然后扩张。4. The stent valve can be radially compressed, accurately delivered in place with the help of the interventional device, and then expanded.
5、扩张释放后的支架瓣膜在径向和轴向符合血管壁形状。5. The expanded and released stent valve conforms to the shape of the blood vessel wall in the radial and axial directions.
6、带舌状结构的支架瓣膜轴向和旋转方向可准确定位和固定。6. The axial direction and rotational direction of the stent valve with tongue-like structure can be accurately positioned and fixed.
附图说明 Description of drawings
图1为本发明带舌状结构的支架瓣膜一实施例的三维透视图;Fig. 1 is the three-dimensional perspective view of an embodiment of the stent valve with tongue-like structure of the present invention;
图2为图1中所示支架的的展开图;Figure 2 is an expanded view of the bracket shown in Figure 1;
图3为图1的俯视图;Fig. 3 is the top view of Fig. 1;
图4为本发明带舌状结构的支架瓣膜又一实施例的三维透视图。Fig. 4 is a three-dimensional perspective view of another embodiment of the stent valve with a tongue-like structure according to the present invention.
具体实施方式 Detailed ways
参见图1、图4,配合参见图2、图3,本发明带舌状结构的支架瓣膜,包括圆管形(如图1所示)或圆管形带径向突出结构(如图4所示)的内层支架体1、至少一个外层舌状结构2(优选为三个)、瓣膜叶3、密封膜4、柔性联结环5和不透X线标志6。内层支架体1由弹性金属线材101编织而成,是一个可以在扩张状态和压缩状态之间径向变形的伸缩体,该内层支架体1可以按照在血管内的血流方向分为上游段11、中段12和下游段13。内层支架体1各网线101之间围成多个可变形单元14,在网状支架的两端形成多个弧形线拐15,在网状支架上还形成多个封闭式线眼16。当外层舌状结构2为三个时,三个外层舌状结构2连接在内层支架体1的外侧并以大约120度转角分配,均由同一或不同网线围合而成。各舌状结构2与内层支架体1在下游段或下游段与中段的交界处相连形成固定缘,并从固定缘开始向上游段延伸至上游段与中段的交界处形成游离缘。舌状结构2用于进入自然瓣叶杯内。当内层支架体1受到径向压缩时,舌状结构2可以同时被径向压缩靠近内层支架体1,当去除压缩制约力后,舌状结构2可以扩张远离内层支架体1呈喇叭形向上游端口开口。本发明中的瓣膜叶3为三片,三片瓣膜叶3呈大约120度转角分配连接在内层支架体1中段12的内侧,瓣膜叶3可以由生物材料构成,也可以由合成材料构成。合成材料可以是弹性体,如硅胶或聚氨酯。合成材料瓣膜叶内有一条至多条加强纤维7,该加强纤维7起止于同一瓣膜叶的两个不同的瓣叶联合点或联合线,连接在支架上。密封膜4覆盖在上游段11的内侧和/或外侧面,此上游段密封膜3可保证血液不会从支架瓣膜同边漏过。密封膜4可以是生物膜或合成膜,生物膜可以在支架内侧、外侧,或内外侧同时存在;合成密封膜可以是弹性体如硅胶,将支架包在中间。多个柔性联结环5和多个不透X线标志6分别设置在网状支架的不同部位。Referring to Fig. 1 and Fig. 4, and referring to Fig. 2 and Fig. 3 for cooperation, the stent valve with tongue-like structure of the present invention includes a circular tube shape (as shown in Figure 1) or a circular tube shape with a radially protruding structure (as shown in Figure 4). (shown) an
本发明带舌状结构的支架的编织方法是:首先建立一个圆管形或圆管形带径向突出结构的内模,然后以弹性金属线材为编织线绕内模的外轮廓进行编织,编织要点可结合图1、图2说明如下:The braiding method of the stent with tongue-shaped structure of the present invention is as follows: first set up a circular tube-shaped or circular tube-shaped internal mold with a radially protruding structure, and then use elastic metal wires as braided wires to weave around the outer contour of the internal mold. The main points can be explained as follows in combination with Figure 1 and Figure 2:
取编织线101从接近支架下游端口的某一点例如图2中的102开始,沿内模的外轮廓螺旋缠绕前进,到相当于支架上游端口的内模端口后再转向对称的相反方向沿内模的外轮廓螺旋缠绕前进,以此重复直到所有的可变形单元14都已建立,编织成一个圆管形或圆管形带径向突出结构的内层支架体。在编织内层支架体时,编织线的不同线段在相交时构成上下交错点103、103’,同一线段在其相邻交错点处的上下位置关系相反,例如图1所示的103和103’。位于同一交错点上的两线段之间可相互滑动。由编织线101的不同线段围合成的可变形单元14一般为四边形,编织线在支架的上游端口和下游端口转向时构成弧形线拐15,故两端的可变形单元14不是标准的四边形。编织时可根据需要在支架的两端或其它部位的某一交错点或拐点处将编织线转至少360度角构成封闭式线眼16,封闭式线眼16可以编织在支架两端,也可以编织在这两者之间。每一段线上可以有一个或多个封闭式线眼16。封闭式线眼16可以与支架在同一外轮廓曲面上或切面上,也可以在与支架相垂直的平面上(径面上)向内或向外,也可以与支架成任意角度。支架两端的弧形线拐15,封闭式线眼16可以在同一水平,也可以在不同水平。Take the
在编织完内层支架体1后,可由同一编织线或不同的编织线从已编织好的内层支架体的下游端口的编织线起点(例如图2中的102)开始重复编织,当编织到相当于绕支架约60度角后(例如到达图2中的104),让编织线脱离已编织好的内层支架体,向外伸出绕成一个舌状结构2后再转向对称的相反方向进入内层支架体重复编织(例如从图2中的105进入),当编织到相当于绕支架约120度角后,再让编织线脱离已编织好的内层支架体(例如从图2中的106出来),向外伸出绕成另一个舌状结构2后再转向对称的相反方向进入内层支架体重复编织(例如从图2中的104进入),直至编织成三个均匀分配的外层舌状结构,最后一段编织线进入内层支架体再重复编织到接近支架的下游端口(例如图2中的107)。在编织外层舌状结构时,要控制编织线从内层支架体伸出的出点和进入内层支架体的进点在内层支架体的同一径向平面上,并控制出点与进点之间的距离相当于绕支架转大约120度角,控制舌状结构的游离缘位于内层支架体的上游段与中段的交界处。本发明中将内层支架体1同一径向平面上的可变形单元数编织成三的倍数,有利于三个舌状结构在编织时沿内层支架体的径向均匀分配。图2所示内层支架体1同一径向平面上的可变形单元数为15,是3的倍数,这样,就可控制每个舌状结构的出点与进点之间的距离为5个可变形单元,相当于绕支架转三分之一圆周,三个舌状结构能均匀分配。After braiding the inner
在编织外层舌状结构2时,编织线101从内层支架体1伸出后,还可以先绕一个至少360度的套环108后再绕一个半环,套环的弧度与半环的弧度相当,套环的一部分与半环共同组成舌状结构。该套环108可以为脱离内层支架体的全游离状态,也可以将其位于内层支架体下游段的部分编织到内层支架体内,如图2所示。When weaving the outer layer tongue-
在编织外层舌状结构2时,还可以在其上游端弧顶绕出一个小圆圈形成封闭式线眼。本实施例中没有显示这一结构。When weaving the outer layer tongue-
本发明的支架在编织时,还可根据需要在编织线的不同线段套上不透X线标志6编织在支架的不同部位。支架的下游端至少设一个不透X线点状标志。支架的上游端或上游段与中段交界处至少设一个不透X线点状标志,这些标志的位置靠近瓣膜叶的杯底。When the stent of the present invention is braided, radio-
综上所述,本发明的带舌状结构的支架瓣膜及其支架的编织方法具有以下的特点和优点:In summary, the stent valve with tongue-shaped structure and the weaving method of the stent of the present invention have the following characteristics and advantages:
1、整个支架由弹性编织线101编织构成1. The whole bracket is composed of
一个单线构成的支架,整体性强,力学上更结实,而不需各线间焊接。单个线起点和终点可相连焊接或重叠。单线支架的编织线两头均在支架下游段13和中段12间。两个头可朝一个方向,向上游端或下游端。单个弹性编织线101可以绕成弧形线拐15和封闭式线眼16。封闭式线眼16可以与支架在同一外轮廓曲面上或切面上,也可以在与支架相垂直的平面上(径面上)向内或向外,也可以在这二者之间。本发明编织的内层支架体1中位于同一径向平面的可变形单元数为三的倍数,这有利于三个瓣膜叶和三个舌状结构均匀分布。交错点上相邻段编织线之间的滑动,保证了支架和舌状结构可以径向压缩,径向扩张。A bracket composed of a single wire has strong integrity and is stronger mechanically without welding between wires. Individual line start and end points can be welded together or overlapped. Both ends of the braided wire of the single-wire stent are between the
2、内层支架体1上设有不透X线标志2. There is an X-ray opaque mark on the
不透X线标志可位于支架瓣膜的上游端,下游端和瓣膜叶结合点。The radiopaque markers can be located at the upstream end of the stent-valve, the downstream end and the junction of the valve leaflets.
3、支架1上设有外层舌状结构23. The
外层舌状结构2不密封膜,可让血液通过。舌状结构2与输放装置上特定的支架拉线配合,可先于支架体单独扩张。扩张的舌状结构2有定位和固定作用。舌状结构2的联合点与瓣叶联合点可有确定的旋转关系,如在同一旋转平面上。The
4、瓣膜叶3内设有加强纤维74. The
加强纤维7有方向选择性地提高了弹性合成材料瓣膜叶3的强度,减少其被撕裂的可能性。加强纤维7使合成瓣膜叶3环形加固,不妨碍瓣膜叶开关;合成瓣膜叶3游离边缘加固,防止其撕裂;合成瓣膜叶3与内层支架体1交结处联合点和联合线加固,使交结处变结实,不被撕裂;使交结处变圆滑,减少血栓形成。The reinforcing fibers 7 selectively increase the strength of the elastic synthetic
5、内层支架体1上的弧形线拐15和封闭式线眼16有利于增加径向弹力,减少材料变形;弹性合成膜内的加强纤维7可以固定在弧形线拐15和封闭式线眼16上面;封闭式线眼16还可以固定瓣膜叶的联合点,如果封闭式线眼16向内侧转90度角并与切面垂直,它可以使联合点内移,瓣膜叶张力下降;弧形线拐15和封闭式线眼16用于与输放装置配合,将支架瓣膜临时固定,压缩在输放装置的内管上。支架拉线如从封闭式线眼穿过,它将不会滑脱和移动。5. The
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US8945209B2 (en) * | 2011-05-20 | 2015-02-03 | Edwards Lifesciences Corporation | Encapsulated heart valve |
CN103705315B (en) * | 2013-12-12 | 2015-10-21 | 宁波健世生物科技有限公司 | Prevent the aortic valve stent of perivalvular leakage |
ES2959773T3 (en) * | 2017-08-11 | 2024-02-28 | Edwards Lifesciences Corp | Sealing element for prosthetic heart valve |
CN110731836B (en) * | 2018-07-20 | 2021-10-12 | 先健科技(深圳)有限公司 | Heart valve |
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2005
- 2005-12-23 CN CN200510111908A patent/CN100594015C/en active Active
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