CN105496608A - Aortic valve device conveyed by catheter - Google Patents

Aortic valve device conveyed by catheter Download PDF

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Publication number
CN105496608A
CN105496608A CN 201610029113 CN201610029113A CN105496608A CN 105496608 A CN105496608 A CN 105496608A CN 201610029113 CN201610029113 CN 201610029113 CN 201610029113 A CN201610029113 A CN 201610029113A CN 105496608 A CN105496608 A CN 105496608A
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CN
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Prior art keywords
support frame
aortic valve
structure
valve apparatus
apparatus according
Prior art date
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CN 201610029113
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Chinese (zh)
Inventor
周庆亮
代高旭
孟坚
可大年
史欢欢
李阳
黄韬
杨宇霆
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北京迈迪顶峰医疗科技有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body

Abstract

The invention discloses an aortic valve device conveyed by a catheter. The aortic valve device comprises a supporting frame, wave leaflets and a skirt. The valve leaflets are fixed to the inner side of the middle of the supporting frame. The skirt is fixed along the periphery of the inner side of the supporting frame and fixed to the valve leaflets. An upper horn mouth structure in a three-valve form is formed by the upper end of the supporting frame. Three circular connection jaws used for loads of the supporting frame are arranged at the tail end of the horn mouth structure. Thorn-shaped positioning rods extending towards the bottom end of the supporting frame to be exposed are arranged on the outer side of the middle of the supporting frame. A lower horn mouth structure used for reducing outward expanding of perivalvular leakage is arranged at the bottom end of the supporting frame.

Description

一种经导管输送主动脉瓣瓣膜装置 One kind aortic valve via catheter delivery means

技术领域 FIELD

[0001]本发明涉及医疗器械领域,尤其涉及一种经导管输送的主动脉瓣瓣膜装置。 [0001] The present invention relates to the field of medical devices, particularly to a catheter delivery device aortic valve via.

背景技术 Background technique

[0002]随着人口老龄化的加重,老年性瓣膜病以及冠心病、心肌梗死后引起的瓣膜病变也越来越常见。 [0002] With the aggravation of an aging population, senile valvular disease and valvular heart disease, myocardial infarction caused by more and more common. 外科手术即人工心脏瓣膜置换或瓣膜成形等手术治疗是心脏瓣膜病的根治方法,但对于一些高龄、多种合并症、或有过外科开胸手术史的患者,外科开胸手术的死亡率很高。 Surgical treatment of surgery that is artificial heart valve replacement or valvuloplasty and so is the cure for heart disease, but for some senior citizens, a variety of complications, or surgical patients had a history of thoracic surgery, thoracic surgery is a surgical mortality rate high. 近年来,随着介入治疗技术的进步,经导管人工瓣膜这一划时代的技术,将介入手术推向了技术巅峰,并试图解决外科瓣膜置换的一切不足。 In recent years, with the advancement of interventional therapy, transcatheter prosthetic valve of this epoch-making technology, surgical intervention pushed the pinnacle of technology, and trying to solve all the lack of surgical valve replacement. 2002年,第一例经导管人工瓣膜置换手术的成功,标志着这一革命性介入医学技术真正进入到了可行性阶段,经过10年的发展,已经有10多万人通过此技术重建心脏功能,获得新的生命。 In 2002, the first cases of transcatheter valve replacement surgery, which symbolized the revolutionary interventional medical technology truly entered into the feasibility stage, after 10 years of development, has more than 10 million people through this reconstruction of cardiac function, new life.

[0003]但是现有的主动脉瓣瓣膜装置或者可以释放回收;或者定位准确但不能回收;或者可以释放回收且定位准确,但适应症受限。 [0003] However, the existing aortic valve means can be released or recovered; or positioning accuracy but can not be recovered; or accurate positioning may be released and recovered, but the indication is limited.

发明内容 SUMMARY

[0004]本发明的目的是提供一种经导管输送的主动脉瓣瓣膜装置,其用于植入到因主动脉瓣狭窄或关闭不全而导致病变的原位主动脉瓣中,以解决主动脉瓣瓣膜装置定位准确以及一旦释放就无法回收的问题;进一步的,解决适应多种病症的问题,如严重钙化的主动脉瓣狭窄、单独的主动脉瓣狭窄或关闭不全以及二瓣化问题。 [0004] The object of the present invention is to provide an aortic valve via a catheter delivery means, which is for implantation due to aortic stenosis or regurgitation caused by lesions in the aortic valve in situ, in order to solve the aorta flap valve means and upon release of positioning accuracy can not be recovered problems; further, to solve the problem to adapt to a variety of disorders, such as severe calcific aortic stenosis, aortic stenosis alone and two or regurgitation problem.

[0005]本发明提供一种经导管输送的主动脉瓣瓣膜装置,所述主动脉瓣瓣膜装置包括:支撑框架;固定在所述支撑框架中间部分内侧的瓣叶;及沿所述支撑框架内侧周边固定、并与所述瓣叶固定的裙边;其中,所述支撑框架的上端形成呈三瓣形式的上喇叭口结构;在所述上喇叭口结构末端有用于所述支撑框架的装载的三个圆形连接爪;所述支撑框架的所述中间部分外侧有向所述支撑框架的底端方向延伸的外露的刺状定位杆;所述支撑框架的底端有用于减少瓣周漏的向外扩张的下喇叭口结构。 [0005] The present invention provides an apparatus for aortic valve via catheter delivery of the aortic valve apparatus comprising: a support frame; fixed inside an intermediate portion of the support frame leaflet; inside and along the support frame peripheral fixed, and the fixed skirt leaflet; wherein an upper end of the support frame is formed as a bell mouth structure of the three forms; the flared end structure for loading of the support frame three circular connection pawls; of the support frame intermediate portion having outer exposed spinous bottom end of the positioning rod extending in the direction of the support frame; bottom end of the support frame for reducing the leakage of paravalvular expanding outwards flared structure.

[0006]可选择地,所述支撑框架的材料为记忆合金,例如为镍钛合金材料;所述中间部分为垂直段,所述下喇叭口结构的开口程度小于所述上喇叭口结构的开口程度。 [0006] Alternatively, the material of the support frame memory alloy such as a nickel titanium alloy material; the middle part of the vertical section, the opening degree of the opening of the bell mouth structure is less than the bell mouth structure degree.

[0007]可选择地,所述支撑框架为呈菱形的网格单元构成的网格结构;且所述上喇叭口结构和下喇叭口结构的末端偏离所述支撑框架的中心轴线的倾角分别为1°到15°。 [0007] Alternatively, the support frame is a diamond-shaped lattice structure composed of grid cell; flare angle of inclination of the upper end bell mouth structure and configuration of the offset from the central axis of the support frame, respectively, 1 ° to 15 °.

[0008]可选择地,所述圆形连接爪的中心为圆形或方形通孔或无孔形状,所述圆形连接爪与上喇叭口结构通过短连杆连接。 [0008] Alternatively, the connection pawl circular or square central circular through-hole or non-porous shape, the circular pawl is connected to the bell mouth structure is connected by a short link.

[0009]可选择地,所述刺状定位杆的根部位置到所述支撑框架的底端距离为1mm到25mm0 [0009] Alternatively, the positioning rods spiny foot position to the bottom end of the support frame distance is 1mm to 25mm0

[0010]可选择地,所述刺状定位杆沿所述支撑框架圆周均匀分布,数量为3个到12个。 [0010] Alternatively, the spinous frame along said support rod positioned circumferentially uniformly distributed, in an amount of 3-12.

[0011 ]可选择地,所述刺状定位杆的长度为4mm到15mm ;刺状定位杆的宽度为0.3mm到Imm0 [0011] Alternatively, the spiny jumper length of 4mm to 15mm; width spiny jumper is 0.3mm to Imm0

[0012]可选择地,所述刺状定位杆的外接圆的圆周直径大于所述支撑框架中间部分垂直段直径3mm到9mm。 [0012] Alternatively, the positioning rods spiny circumcircle diameter larger than the circumference of the supporting frame middle portion of the vertical section of diameter 3mm to 9mm.

[0013]可选择地,所述刺状定位杆与支撑框架可以是一体式结构或分开式结构,一体式结构采用激光切割而成,分开式结构采用激光焊接而成。 [0013] Alternatively, the positioning rod spiny support frame may be a unitary structure or separate structure, unitary structure laser cut from a separate laser welded structure.

[0014]可选择地,所述支撑框架底端的扩张的下喇叭口结构高度为3mm到8mm,其直径大于所述支撑框架中间部分垂直段3mm到6_。 [0014] Alternatively, the support height of the bell mouth structure expanded bottom frame is 3mm to 8mm, having a diameter larger than the intermediate portion of the vertical section of the support frame to 3mm 6_.

[0015]可选择地,所述支撑框架的中间部分与所述支撑框架的上喇叭口结构通过短连杆彼此连接。 [0015] Alternatively, the support structure of the flared portion of the intermediate frame and the support frame connected to one another by a short link.

[0016] 可选择地,所述短连杆长度为1.5mm到4mm,宽度为0.25mm到1mm。 [0016] Alternatively, the short link length of 1.5mm to 4mm, width of 0.25mm to 1mm.

[0017]可选择地,所述支撑框架的相邻的所述网格单元之间采用左右内凹的短连杆连接。 [0017] Alternatively, the support between adjacent short link frame using the left and right grid units concave connector.

[0018]可选择地,所述左右内凹的短连杆的最小宽度为0.25mm到0.5mm。 [0018] Alternatively, the minimum width of the right and left short concave links of 0.25mm to 0.5mm.

[0019]可选择地,所述左右内凹的短连杆为左右两个半圆形成的内凹结构或一小段直线段加左右圆弧形成的内凹结构。 Indentations, or indentations short straight segments forming an arc of about plus [0019] Alternatively, the left and right concave short link about two semicircular formation.

[0020]可选择地,所述瓣叶的材料为猪心包、牛心包、马心包或高分子材料聚四氟乙烯。 [0020] Alternatively, the leaflet material is porcine pericardium, bovine pericardium, or pericardial horses polytetrafluoroethylene polymer material.

[0021]可选择地,所述裙边的材料为猪心包、牛心包、马心包、高分子材料聚四氟乙烯或涤纶布。 [0021] Alternatively, the skirt material is porcine pericardium, bovine pericardium, horse pericardium, polytetrafluoroethylene or polyester cloth polymer material.

[0022]本发明的优点包括通过在主动脉瓣瓣膜的支撑框架上端设置成喇叭口结构而喇叭口结构的末端有三个圆形连接爪,实现了主动脉瓣瓣膜装置的装载与回收;通过支撑框架的中间部分向下外露的刺状定位杆,实现了主动脉瓣瓣膜装置的精确定位,使得手术过程更加安全可靠。 [0022] The advantages of the present invention comprises a bell mouth configuration provided by the upper end of the support frame and the end of the aortic valve has three circular configuration of the flare connection claws achieve a loading and recovery of aortic valve means; by supporting the intermediate portion of the frame exposed downward spiny jumper, to achieve a precise positioning of the aortic valve means, such that the surgical procedure more secure.

附图说明 BRIEF DESCRIPTION

[0023]图1是本发明的一种主动脉瓣瓣膜装置的示意图; [0023] FIG. 1 is a schematic view of an aortic valve of the apparatus according to the present invention;

[0024]图2是本发明的一种主动脉瓣瓣膜装置的俯视图; [0024] FIG. 2 is a plan view of an aortic valve device according to the present invention;

[0025]图3是本发明的一种主动脉瓣瓣膜装置的展开示意图; [0025] FIG. 3 is a developed view of an aortic valve of the apparatus according to the present invention;

[0026]图4是本发明的一种主动脉瓣瓣膜装置刺状定位杆的展开示意图; [0026] FIG. 4 is an aortic valve of the present invention, the positioning means spiny expanded schematic rod;

[0027]图5是本发明的主动脉瓣瓣膜装置装载至输送系统的示意图; [0027] FIG. 5 is an aortic valve apparatus of the present invention is loaded into the delivery system schematic;

[0028]图6是本发明的主动脉瓣瓣膜装置刺状定位杆释放的示意图; [0028] FIG. 6 is a schematic diagram aortic valve positioning device according to the present invention spiny release lever;

[0029]图7是本发明的主动脉瓣瓣膜装置刺状定位杆及支撑框架底端释放的示意图; [0029] FIG. 7 is a schematic diagram aortic valve means spinous frame and the support rod is positioned to release the bottom end of the present invention;

[0030]图8是本发明的主动脉瓣瓣膜装置完全释放示意图; [0030] FIG. 8 is an aortic valve device according to the present invention fully released schematic;

[0031 ]图9是本发明的主动脉瓣瓣膜装置在心脏位置刺状定位杆定位示意图; [0031] FIG. 9 is an aortic valve apparatus of the present invention is positioned in the heart spiny schematic jumper;

[0032]图10是本发明的主动脉瓣瓣膜装置在心脏位置刺状定位杆及支架底端定位示意图; [0032] FIG. 10 is a device of the present invention aortic valve in the heart spiny positioning rod holder and a bottom end positioned a schematic view;

[0033]图11是本发明的主动脉瓣瓣膜装置在心脏位置完全释放示意图; [0033] FIG. 11 is a aortic valve device of the invention in a schematic view of the heart completely released position;

具体实施方式 Detailed ways

[0034]本发明的一种经导管输送的主动脉瓣瓣膜装置用于植入到因主动脉瓣狭窄或关闭不全而导致病变的原位主动脉瓣中,以解决主动脉瓣瓣膜装置定位准确以及一旦释放就无法回收的问题;另外也试图解决适应多种病症的问题,如严重钙化的主动脉瓣狭窄、单独的主动脉瓣狭窄或关闭不全以及二瓣化问题。 [0034] A according to the present invention by means aortic valve for implantation into a catheter delivery by aortic stenosis or regurgitation caused situ lesions in aortic valve, aortic valve means to solve the accurate positioning Once released, and the problem can not be recovered; There is also trying to solve the problem to adapt to a variety of disorders, such as severe calcific aortic stenosis, aortic stenosis alone or regurgitation and two issues.

[0035]下面结合附图,对本发明的实施例作详细描述。 [0035] The accompanying drawings in conjunction with the following, embodiments of the present invention are described in detail.

[0036]如图1到图4所示的一种主动脉瓣瓣膜装置100,用于植入到因主动脉瓣狭窄或关闭不全而导致病变的原位主动脉瓣中,包括:支撑框架,固定在所述支撑框架中间部分内侧的瓣叶104,以及沿所述支撑框架内侧周边固定、并与所述瓣叶固定的裙边102。 [0036] An aortic valve apparatus 1 shown in FIG. 4 to FIG. 100, the aortic valve for implantation in situ due to aortic stenosis or regurgitation caused lesions, comprising: a support frame, fixed to the intermediate portion of the support frame inside the leaflet 104, and a peripheral edge fixed to said inner support frame, and the skirt 102 fixed leaflet. 进一步说,裙边102沿支撑框架四周围成一圈,并用缝合线缝合固定;瓣叶104为三片(请参考图2),缝于支撑框架中间部分,并与裙边102固定缝合。 Further, the supporting frame the skirt 102 along a circle four weeks, and sutured with sutures; three leaflets 104 (refer to FIG. 2), the support frame slit intermediate portion, with the skirt 102 and suture fixation.

[0037]所述支撑框架包括:在所述支撑框架的上端形成的呈三瓣形式的上喇叭口结构105,在所述上喇叭口结构末端有用于所述支撑框架的装载的三个圆形连接爪106;所述支撑框架的中间部分,其外侧有向所述支撑框架的底端方向延伸的外露的刺状定位杆103 ;位于所述支撑框架的底端的用于减少瓣周漏的向外扩张的下喇叭口结构101。 [0037] The support frame comprises: a bell mouth shape in the form of three structures formed in an upper end of the support frame 105, the upper end structure has three circular bell mouth for loading the support frame connecting pawls 106; an intermediate portion of the support frame, which is positioned outside spiny rod 103 extending toward the base end of the exposed direction of the support frame; a bottom end of the support frame for reducing the PVL bellmouth 101 at an expanded configuration. (请参考图1)。 (Please refer to FIG. 1).

[0038]所述支撑框架的材料可以为记忆合金,例如为镍钛合金材料。 [0038] The material of the support frame memory alloy may be, for example, a nickel-titanium alloy material.

[0039] 所述中间部分为垂直段,所述下喇叭口结构101的开口程度小于所述上喇叭口结构105的开口程度。 [0039] The middle part of the vertical section, the degree of opening of the bell mouth structure 101 is less than the degree of opening of the bell mouth structure 105.

[0040]所述支撑框架为呈菱形的网格单元构成的网格结构;所述支撑框架的相邻的所述网格单元之间采用左右内凹的短连杆连接。 [0040] The supporting frame is a diamond-shaped grid structure of the grid units; employed between the support frame adjacent the right and left concave grid cell short link connection. 可选择地,所述左右内凹的短连杆的最小宽度为0.25mm至Ij0.5mm。 Alternatively, the minimum width, the left and right short link concave is to 0.25mm Ij0.5mm. 可选择地,所述左右内凹的短连杆为左右两个半圆形成的内凹结构或一小段直线段加左右圆弧形成的内凹结构。 Alternatively, indentations or concave configuration around the short straight line segments plus approximately concave short link formed about two semicircular arc formation.

[0041 ]所述上喇叭口结构和下喇叭口结构的末端偏离所述支撑框架的中心轴线的倾角分别为1°到15°。 Inclination [0041] The upper end of the bell mouth and the bell mouth structure departing from the structure of the central axis of the support frame are respectively 1 ° to 15 °. 下喇叭口结构101与支撑框架的中间部分平滑过渡;支撑框架的中间部分与上喇叭口结构105平滑过渡;支撑框架的中间部分与上喇叭口结构105通过短连杆107连接(请参考图4),所述短连杆长度为1.5mm到4mm,宽度为0.25mm至Ijlmm。 The bell mouth structure 101 and a smooth transition of the intermediate portion of the support frame; intermediate portion of the support frame 105 with the bell mouth structure smooth transition; intermediate portion of the support frame 105 with the bell mouth structure are connected by a short rod 107 (refer to FIG. 4 ), a short link length of 1.5mm to 4mm, a width of 0.25mm to Ijlmm. 支撑框架的呈菱形的网格单元之间采用短连杆108连接(请参考图4);上喇叭口结构105中间部分呈菱形展开,上喇叭口结构105均匀分布于支撑框架四周;圆形连接爪106与上喇叭口结构105通过短连杆相连,圆形连接爪106为空心或实心结构,进一步说,所述圆形连接爪106的中心为圆形或方形通孔或无孔形状。 Using diamond-shaped grid cells between the support frame 108 is connected to a short link (refer to FIG. 4); the intermediate portion of the bell mouth structure 105 form diamond-shaped, the flared structure 105 uniformly distributed in the four weeks the support frame; circular connector pawl 106 and the bell mouth structure 105 connected by a short link, circular pawl 106 is connected to a hollow or solid structure, further, connected to the center of the circular pawl 106 is circular or square shaped through holes or non-porous.

[0042]刺状定位杆103位于支撑框架中间部分,呈圆周均匀分布于支撑框架中间部分,刺的方向指向支撑框架的下喇叭口结构101;所述刺状定位杆的根部位置到所述支撑框架的底端距离为1mm到25mm。 [0042] spiny jumper intermediate portion 103 of the support frame, circumferentially uniformly distributed in the intermediate portion of the support frame, the puncture direction pointing toroidal support frame structure 101; root positions of said rod to the spinous positioning the support bottom frame distance of 1mm to 25mm. 所述刺状定位杆沿所述支撑框架圆周均匀分布,数量为3个到12个。 The spinous lever along said support frame positioned circumferentially uniformly distributed, in an amount of 3-12. 可选择地,所述刺状定位杆的长度为4mm到15mm;刺状定位杆的宽度为0.3mm到1mm。 Alternatively, the spinous jumper length of 4mm to 15mm; width spiny jumper is 0.3mm to 1mm. 所述刺状定位杆的外接圆的圆周直径大于所述支撑框架中间部分垂直段直径3_到9_。 The spinous jumper circumscribed circle diameter is greater than the circumference of the support frame intermediate portion of the vertical section to the diameter 9_ 3_. 所述刺状定位杆与支撑框架可以是一体式结构或分开式结构,一体式结构采用激光切割而成,分开式结构采用激光焊接而成。 The spinous jumper support frame may be a unitary structure or separate structure, unitary structure laser cut from a separate laser welded structure.

[0043]下喇机口结构高度为3mm到8mm,其外接圆的直径大于所述支撑框架中间部分垂直段3mm到6mm。 [0043] La machine outlet structure at a height of 3mm to 8mm, is greater than the diameter of the circumscribed circle of the support frame intermediate portion of the vertical section of 3mm to 6mm.

[0044]所述瓣叶的材料和所述裙边的材料可以分别为猪心包、牛心包、马心包或高分子材料聚四氟乙烯。 [0044] the material of the leaflet and the skirt may be respectively porcine pericardium, bovine pericardium, or pericardial horses polytetrafluoroethylene polymer material.

[0045]通过在主动脉瓣瓣膜的支撑框架上端设置成喇叭口结构而喇叭口结构的末端有三个圆形连接爪,实现了主动脉瓣瓣膜装置的装载与回收;通过支撑框架的中间部分向下外露的刺状定位杆,实现了主动脉瓣瓣膜装置的精确定位,使得手术过程更加安全可靠。 [0045] provided at the upper end by the supporting frame of the aortic valve and the flared end structure of a bellmouth structure has three circular connection claws achieve a loading and recovery of aortic valve means; by the intermediate portion of the support frame the exposed spinous jumper, to achieve a precise positioning of the aortic valve means, such that the surgical procedure more secure.

[0046]本发明实施例所述的一种经导管输送主动脉瓣瓣膜装置工作过程如下: [0046] An embodiment of the present invention, the embodiment of transcatheter delivery aortic valve means works as follows:

[0047]先将所述主动脉瓣瓣膜装置100通过一定装置收缩装载入输送系统200的头端201和装载鞘202中(请参考图5),通过手柄203将输送系统200的装载鞘202向后移动,将所述主动脉瓣瓣膜装置100的刺状定位杆103释放出来(请参考图6和图9),此时由于所述主动脉瓣瓣膜装置100材料自身的记忆合金的特性,刺状定位杆103自动膨胀,慢慢向下推送输送系统200,使得刺状定位杆103接触到人体自然瓣叶组织300,停止推送输送系统200。 [0047] The aortic valve is first loaded into the apparatus 100 through a certain contraction means head end 201 of delivery system 200 and the loading sheath 202 (refer to FIG. 5), the handle 203 by loading the delivery system 200 of the sheath 202 moves backward, the positioning rod will spiny aortic valve 103 of the apparatus 100 is released (refer to FIGS. 6 and 9), this time due to characteristics of the material of the aortic valve 100 itself memory alloy means, spiny automatic positioning rod 103 expands and slowly push down the delivery system 200, the lever 103 is positioned such that the prongs contact the body's natural tissue leaflet 300, a push delivery system 200 is stopped. 再通过手柄203将输送系统200的头端201向前移动,使得所述主动脉瓣瓣膜装置100的下喇叭口结构1I从输送系统200的头端201释放出来,由于所述主动脉瓣瓣膜装置100材料自身的记忆合金的特性,下喇叭口结构101自动膨胀(请参考图7),将人体自然瓣叶组织300撑开,此时人体自然瓣叶组织300处于所述主动脉瓣瓣膜装置100的下喇叭口结构101和刺状定位杆103之间(请参考图10),所述主动脉瓣瓣膜装置100完成精确定位。 The handle 203 and through the delivery system 200 of the forward movement of the head end 201, such that the aortic valve apparatus 1I toroidal structure 100 is released from the head end 201 of delivery system 200, because the aortic valve means 100 characteristic memory alloy material itself, the self-expanding flared structure 101 (refer to FIG. 7), the body's natural tissue leaflets 300 distraction, at this time the body's natural tissue leaflet aortic valve 300 is in the apparatus 100 under the bell mouth structure (refer to FIG. 10) 101 and 103. spiny positioning rod, the aortic valve apparatus 100 complete the accurate positioning. 再次通过输送系统200的手柄203将装载鞘202继续向后移动,将所述主动脉瓣瓣膜装置100的上喇叭口结构105和圆形连接爪106从装载鞘202中释放出来(请参考图8),由于所述主动脉瓣瓣膜装置100材料的自身的记忆合金的特性,上喇叭口结构105自动膨胀至最大,与血管壁贴合固定(请参考图11),最后输送系统200与圆形连接爪106脱离,撤出输送系统200,所述主动脉瓣瓣膜装置100植入完成。 Again knob 203 through the delivery system 200 will load the sheath 202 continues to move rearward, the connecting structure 100 of the flare 105 and the aortic valve means circular pawl 106 is released from the loading sheath 202 (refer to FIG. 8 ), due to the characteristics of its shape memory alloy material 100 of the aortic valve means, the bell mouth structure 105 automatically expands to a maximum, with the vessel wall attached to a fixed (refer to FIG. 11), and finally the delivery system 200 and the circular connection pawl 106 disengaged, the withdrawal of the delivery system 200, the aortic valve implantation apparatus 100 is completed.

[0048]以上实施方式仅用于说明本发明,而并非对本发明的限制,有关技术领域的普通技术人员,在不脱离本发明的精神和范围的情况下,还可以做出各种变化和变型,因此所有等同的技术方案也属于本发明的范畴,本发明的专利保护范围应由权利要求限定。 [0048] The above embodiments are merely illustrative of the present invention, and are not restrictive of the invention, relating to ordinary skill in the art, without departing from the spirit and scope of the present invention, can make various changes and modifications , all equivalent technical solutions also within the scope of the present invention, the scope of the present invention patent is defined by the appended claims.

Claims (10)

  1. 1.一种经导管输送的主动脉瓣瓣膜装置,所述主动脉瓣瓣膜装置包括:支撑框架;固定在所述支撑框架中间部分内侧的瓣叶;及沿所述支撑框架内侧周边固定、并与所述瓣叶固定的裙边;其特征在于:所述支撑框架的上端形成呈三瓣形式的上喇叭口结构;在所述上喇叭口结构末端有用于所述支撑框架的装载的三个圆形连接爪;所述支撑框架的所述中间部分外侧有向所述支撑框架的底端方向延伸的外露的刺状定位杆;所述支撑框架的底端有用于减少瓣周漏的向外扩张的下喇叭口结构。 An aortic valve means via catheter delivery of the aortic valve apparatus comprising: a support frame; fixed inside an intermediate portion of the support frame leaflet; and the inner periphery of the fixed frame along said support, and and fixing said skirt leaflet; characterized in that: the upper end of the support frame is formed as a bell mouth on the three forms of the structure; a three loading of the support frame structure at the upper end of the bell mouth circular connection pawl; the outer portion of the middle support frame spiny exposed positioning rod extending toward the base end direction of the support frame; bottom end of the support frame to reduce outward PVL under bell structure expansion.
  2. 2.根据权利要求1所述的主动脉瓣瓣膜装置,其特征在于:所述支撑框架为镍钛合金材料;所述中间部分为垂直段,所述下喇叭口结构的开口程度小于所述上喇叭口结构的开口程度。 2. aortic valve apparatus according to claim 1, wherein: the support frame is a nickel-titanium alloy material; the opening degree of the middle part of the vertical section, the lower bell mouth structure is less than the upper the degree of opening of the bell mouth structure.
  3. 3.根据权利要求1所述的主动脉瓣瓣膜装置,其特征在于:所述支撑框架为呈菱形的网格单元构成的网格结构;且所述上喇叭口结构和下喇叭口结构的末端偏离所述支撑框架的中心轴线的倾角分别为1°到15°。 3. The aortic valve apparatus according to claim 1, wherein: the support frame is a lattice structure of diamond-shaped grid units; and the upper end bell mouth structure and lower structure of bellmouth offset from the center axis of inclination of the supporting frame, respectively, 1 ° to 15 °.
  4. 4.根据权利要求1所述的主动脉瓣瓣膜装置,其特征在于:所述圆形连接爪的中心为圆形或方形通孔或无孔形状,所述圆形连接爪与上喇叭口结构通过短连杆连接。 4. The aortic valve apparatus according to claim 1, wherein: said circular center connecting claw round or square through-hole or non-porous shape, the circular pawl connected to the bell mouth structure connected by a short link.
  5. 5.根据权利要求1所述的主动脉瓣瓣膜装置,其特征在于:所述刺状定位杆与所述支撑框架是一体式结构或通过焊接连接的结构。 The aortic valve apparatus according to claim 1, wherein: said jumper prongs integral with the support frame structure by welding or connecting structure.
  6. 6.根据权利要求1所述的主动脉瓣瓣膜装置,其特征在于:所述支撑框架的中间部分与所述支撑框架的上喇叭口结构通过短连杆彼此连接。 6. aortic valve apparatus according to claim 1, characterized in that: the bell mouth structure of the support frame intermediate portion of the support frame connected to one another by a short link.
  7. 7.根据权利要求3所述的主动脉瓣瓣膜装置,其特征在于:所述支撑框架的相邻的所述网格单元之间采用左右内凹的短连杆连接。 7. aortic valve apparatus according to claim 3, wherein: right and left recessed using short link connection between the adjacent grid cells of the support frame.
  8. 8.根据权利要求7所述的主动脉瓣瓣膜装置,其特征在于:所述左右内凹的短连杆为左右两个圆弧形成的内凹结构或一小段直线段加左右圆弧形成的内凹结构。 8. aortic valve apparatus according to claim 7, wherein: the left and right concave indentations short link arcs formed about two short straight line segments or arcs formed about plus concave structure.
  9. 9.根据权利要求1所述的主动脉瓣瓣膜装置,其特征在于:所述瓣叶的材料为猪心包、牛心包、马心包或高分子材料聚四氟乙烯。 9. aortic valve apparatus according to claim 1, wherein: the material of the leaflet is porcine pericardium, bovine pericardium, or pericardial horses polytetrafluoroethylene polymer material.
  10. 10.根据权利要求1所述的主动脉瓣瓣膜装置,其特征在于:所述裙边的材料为猪心包、牛心包、马心包、高分子材料聚四氟乙烯或涤纶布。 10. The aortic valve apparatus according to claim 1, wherein: said skirt material is porcine pericardium, bovine pericardium, horse pericardium, polytetrafluoroethylene or polyester cloth polymer material.
CN 201610029113 2016-01-11 2016-01-11 Aortic valve device conveyed by catheter CN105496608A (en)

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