WO2017121194A1 - 一种具有定位环的经导管输送主动脉瓣瓣膜装置 - Google Patents

一种具有定位环的经导管输送主动脉瓣瓣膜装置 Download PDF

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Publication number
WO2017121194A1
WO2017121194A1 PCT/CN2016/107224 CN2016107224W WO2017121194A1 WO 2017121194 A1 WO2017121194 A1 WO 2017121194A1 CN 2016107224 W CN2016107224 W CN 2016107224W WO 2017121194 A1 WO2017121194 A1 WO 2017121194A1
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Prior art keywords
valve device
aortic valve
positioning
circular
main bracket
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PCT/CN2016/107224
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English (en)
French (fr)
Inventor
代高旭
周庆亮
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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Publication of WO2017121194A1 publication Critical patent/WO2017121194A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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; Valves implantable in the body
    • A61F2/2412—Heart 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; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body

Definitions

  • the present invention relates to the field of medical devices, and more particularly to a transcatheter delivery aortic valve device having a positioning ring.
  • Surgical treatment such as prosthetic heart valve replacement or valvuloplasty, is the cure for valvular heart disease.
  • the mortality rate of surgical thoracotomy is very high. high.
  • the epoch-making technique of transcatheter prosthetic valves has pushed interventional surgery to the peak of technology and tried to solve all the deficiencies of surgical valve replacement.
  • the success of the first transcatheter prosthetic valve replacement surgery marked the beginning of this revolutionary interventional medical technology into a feasible stage. After 10 years of development, more than 100,000 people have rebuilt heart function through this technology. Get a new life.
  • the existing aortic valve device may be released for recovery; or the positioning may be accurate but not recyclable; or the release may be released and the positioning is accurate, but the indication is limited.
  • the present invention provides a transcatheter delivery aortic valve device having a positioning ring, the aorta
  • the valve device includes: a main bracket; a leaflet fixed inside the middle portion of the main bracket; and a skirt fixed along the inner periphery of the main bracket and fixed to the leaflet; wherein the upper end of the main bracket Forming an upper bell mouth structure in the form of a three-lobed; at the upper end of the upper bell mouth structure, there are three upper end circular connecting claws for loading the main bracket; the bottom end of the main bracket is used for reducing the leakage of the valve a downwardly flared lower bell mouth structure; the lower bellows structure has three lower end circular connecting claws at a lower end thereof; the aortic valve device further includes a positioning ring for positioning on a lower side of the main bracket
  • the positioning ring includes three V-shaped or U-shaped circular arc segments, and ends of each of the V-shaped or U-shaped circular arc segments are connected to each other to form an annul
  • the main bracket and/or the positioning ring is a Nitinol material; the middle portion is a vertical section, and the lower bell mouth structure has a degree of opening smaller than a degree of opening of the upper bell mouth structure.
  • the lower bell mouth structure is a flat flare structure that is slightly expanded outward.
  • the lower bell mouth structure height is 3mm to 8mm.
  • the main bracket is a grid structure formed by a diamond-shaped grid unit; and an inclination of an end of the upper bell mouth structure and the lower bell mouth structure from the central axis of the main bracket is 1° to 15°.
  • the center of the upper end circular connecting claw is a circular or square through hole or a non-porous shape, and the upper end circular connecting claw and the upper bell mouth structure are connected by a short connecting rod.
  • the intermediate portion of the main bracket and the upper bell structure of the main bracket are connected to each other by a short link.
  • the short link has a length of 1.5 mm to 4 mm and a width of 0.25 mm to 1 mm.
  • a short connecting rod is used between the adjacent grid units of the main bracket connection.
  • the minimum width of the left and right concave short links is 0.25 mm to 0.5 mm.
  • the left and right concave short links are a concave structure formed by two left and right circular arcs or a concave structure formed by a short straight line segment and left and right circular arcs.
  • the middle of the lower end connecting claw is a circular hole or a square hole, and the bottom end of the lower end connecting claw is a concave arc structure; the lower end connecting claw is evenly distributed at the bottom end of the main bracket. .
  • the middle of the positioning circular connecting claw is a circular hole or a square hole, and the top end of the positioning circular connecting claw is a concave circular arc structure.
  • the concave arc of the bottom end of the lower end circular connecting claw has a radius of 0.3 mm to a radius of 1 mm.
  • the circular arc of the concave end of the positioning circular connecting claw has a radius of 0.3 mm to a radius of 1 mm.
  • the material of the leaflet is pig pericardium, bovine pericardium, horse pericardium or polymer material polytetrafluoroethylene;
  • the material of the skirt is pig pericardium, bovine pericardium, horse pericardium, polymer material polytetrafluoroethylene Ethylene or polyester cloth.
  • the positioning line is a filament material such as a polymer material thread or a nickel-titanium wire such as a general medical suture or a degradable medical suture.
  • the positioning ring is composed of 3 to 12 V-shaped or U-shaped structural units having a rod width of 0.3 mm to 1 mm, and the positioning ring has a height of 7 mm to 15 mm.
  • the length of the positioning line is increased by 5 mm to 12 mm than the height of the positioning ring.
  • the invention has the advantages that the loading and recovery of the aortic valve device is achieved by three circular connecting claws arranged at the upper end of the main stent of the aortic valve as a flared structure; the straight horn passing through the bottom end of the main stent The shape of the mouth reduces the leakage of the valve; the positioning of the aortic valve device is achieved by the positioning line and the positioning ring at the lower end of the main stent, so that the surgical procedure is safer and more reliable.
  • Figure 1 is a schematic view showing the unfolded state of an aortic valve device of the present invention
  • FIG. 2 is a schematic view showing the positioning of an aortic valve device of the present invention
  • Figure 3 is a schematic view showing the structure of a positioning ring of an aortic valve device of the present invention
  • Figure 4 is a schematic illustration of the loading of the aortic valve device of the present invention into a delivery system
  • Figure 5 is a schematic illustration of the semi-release of the positioning ring of the aortic valve device of the present invention.
  • Figure 6 is a schematic view showing the complete release of the positioning ring of the aortic valve device of the present invention.
  • Figure 7 is a schematic view showing the position of the aortic valve device of the present invention delivered to the heart;
  • Figure 8 is a schematic view showing the semi-release of the aortic valve device of the present invention in a cardiac position positioning ring;
  • Figure 9 is a schematic view showing the complete release of the aortic valve device of the present invention at the cardiac position positioning ring;
  • Figure 10 is a schematic view showing the positioning of the main stent of the aortic valve device of the present invention at the heart position;
  • Figure 11 is a schematic illustration of the complete release of the aortic valve device of the present invention at the heart position.
  • the present invention provides a transcatheter delivery aortic valve device having a positioning ring for implantation into an in situ aortic valve resulting from aortic stenosis or regurgitation or regurgitation To solve the problem of accurate positioning of the aortic valve device; further, to solve problems that adapt to a variety of conditions, such as aortic stenosis or regurgitation or reflux or two-valve.
  • An aortic valve device 100 for implantation into an orthotopic aortic valve resulting from a lesion of the aortic stenosis or regurgitation, the aortic valve device comprising a main bracket; a leaflet 104 fixed inside the intermediate portion of the main bracket; and a skirt 102 fixed along the inner periphery of the main bracket and fixed to the leaflet 104; further, the skirt 102 is along the main bracket surrounding In a circle, and sutured with sutures; the leaflets 104 are three pieces, which are sewn in the middle part of the main frame and fixedly stitched with the skirt 102.
  • the upper end of the main bracket forms an upper bell mouth structure 105 in the form of three lobes; at the upper end of the upper bell mouth structure 105, there are three upper end circular connecting claws 106 for loading the main bracket, It may be hollow or solid; the bottom end of the main bracket has an outwardly flared lower bell structure 101 for reducing the leakage of the valve; the lower end of the lower bell structure 101 has three lower end circular connecting claws 110;
  • the aortic valve device further includes a positioning ring 103 for positioning on a lower side of the main bracket, the positioning ring 103 including three V-shaped or U-shaped arc segments, each of the V-shaped or U-shaped arcs The ends of the segments are connected to each other to form an annular shape, and three positioning circular connecting claws 111 are formed on the end portions; the lower circular connecting claws 110 and the corresponding positioning circular connecting claws 111 respectively pass through flexible positioning lines 107 connections.
  • the main bracket and the positioning ring 103 may be a Nitinol material; the middle portion is a vertical section, and the opening of the lower bell mouth structure 101 is smaller than the opening degree of the upper bell mouth structure 105. Further, the lower bell mouth structure 101 is an outwardly slightly expanded flat bell structure. The lower bell mouth structure 101 has a height of 3 mm to 8 mm.
  • the main bracket may be a grid structure formed by a diamond-shaped grid unit; and the inclinations of the ends of the upper bell mouth structure 105 and the lower bell mouth structure 101 deviating from the central axis of the main bracket are respectively 1° to 15 °.
  • the middle portion of the main bracket smoothly transitions with the lower bell mouth structure 101 and the upper bell mouth structure 105.
  • the center of the upper end circular connecting claw 106 is a circular or square through hole or a non-porous shape, and the upper end circular connecting claw 106 and the upper bell mouth structure 105 are connected by a short link.
  • the middle portion of the main bracket and the upper bell mouth structure 105 of the main bracket pass The short links 108 are connected to each other.
  • the short link has a length of 1.5 mm to 4 mm and a width of 0.25 mm to 1 mm.
  • a short link connection 109 that is concave in the left and right may be used between adjacent grid cells of the main bracket.
  • the minimum width of the left and right concave short links is 0.25 mm to 0.5 mm.
  • the left and right concave short links may be a concave structure formed by two left and right circular arcs or a concave structure formed by adding a small straight line segment and a left and right circular arc.
  • the middle of the lower end connecting claw 110 may be a circular hole or a square hole, and the bottom end of the lower end circular connecting claw 110 is a concave arc structure; the lower end circular connecting claw 110 is evenly distributed at the bottom end of the main bracket. .
  • the middle of the positioning circular connecting claw 111 is a circular hole or a square hole, and the top end of the positioning circular connecting claw 111 has a concave circular arc structure 112 (see FIG. 3).
  • the circular arc of the bottom end of the lower end circular connecting claw 110 has a radius of 0.3 mm to a radius of 1 mm.
  • the circular arc of the top end of the positioning circular connecting claw 111 has a radius of 0.3 mm to a radius of 1 mm.
  • the material of the leaflet may be a pig pericardium, a bovine pericardium, a horse pericardium or a polymer material polytetrafluoroethylene; the material of the skirt is pig pericard, bovine pericardium, horse pericard, polymer material polytetrafluoroethylene or polyester cloth.
  • the positioning line 107 may be a filament of a polymer material such as a general medical suture or a degradable medical suture or a nickel wire.
  • the positioning ring 103 may also be composed of 3 to 12 V-shaped or U-shaped structural units having a rod width of 0.3 mm to 1 mm, and the positioning ring 103 has a height of 7 mm to 15 mm.
  • the length of the positioning line 107 may be increased by 5 mm to 12 mm than the height of the positioning ring 103.
  • the middle portion of the upper bell mouth structure 105 may be expanded in a diamond shape, and the upper bell mouth structure 105 is evenly distributed around the main bracket.
  • Transcatheter delivery aortic valve device with positioning ring according to an embodiment of the invention The process is as follows:
  • the aortic valve device 100 (including the main stent and the positioning ring 103) is first loaded into the loading sheath 202 of the delivery system 200 by a certain device (refer to FIG. 4), and the delivery system 200 includes a head end 201, loading The sheath 202 and the handle 203 and the like.
  • the delivery system 200 is delivered to the human lesion site by intervention (see Figure 7).
  • the loading sheath 202 of the delivery system 200 is then moved back to the fixed position by the handle 203, and the positioning ring 103 of the aortic valve device 100 is released halfway (please refer to Figures 5 and 8), at this time
  • the shape and memory characteristics of the aortic valve device 100, the positioning ring 103 automatically expands to form a bell mouth shape (please refer to FIG. 5 and FIG. 8), and then slowly pushes the delivery system 200 toward the ventricle, so that the positioning ring 103 contacts the human body naturally.
  • the push delivery system 200 is stopped.
  • the loading sheath 202 of the delivery system 200 is again moved back to the fixed position by the handle 203, so that the positioning ring 103 is completely released from the loading sheath 202, at which time the positioning ring 103 is fully automatically expanded to the maximum size due to the material shape memory property. (Please refer to Figures 6 and 9).
  • the human natural leaflet tissue 300 is between the lower bell structure 101 and the positioning ring 103 of the aortic valve device 100 (refer to the figure).
  • the aortic valve device 100 performs precise positioning.
  • the loading sheath 202 is again moved rearwardly by the handle 203 of the delivery system 200, releasing the upper flare structure 105 and the upper circular connecting jaw 106 of the aortic valve device 100 from the loading sheath 202, as described Aortic valve device 100
  • the shape memory characteristic of the material, the upper bell mouth structure 105 automatically expands to the maximum, and is fixed to the blood vessel wall (refer to FIG. 11), the conveying system 200 and the upper end circular connecting claw 106, and finally the delivery system 200 is withdrawn, the main The anastomotic valve device 100 is implanted.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

一种经导管输送的主动脉瓣瓣膜装置（100），其包括：主支架；固定在主支架中间部分内侧的瓣叶（104）；沿主支架内侧周边固定、并与瓣叶（104）固定的裙边（102）；其中，主支架的上端形成呈三瓣形式的上喇叭口结构（105）；在上喇叭口结构（105）上端有用于主支架的装载的三个上端圆形连接爪（106）；主支架的底端有用于减少瓣周漏的向外扩张的下喇叭口结构（101）；下喇叭口结构（101）的下端有三个下端圆形连接爪（110）；主动脉瓣瓣膜装置还包括位于主支架下侧的用于定位的定位环（103），定位环（103）包括三个V字形或U字形圆弧段，各个V字形或U字形圆弧段的端部彼此相连形成环状，并在端部上形成三个定位圆形连接爪（111）；下端圆形连接爪（110）与相应的定位圆形连接爪（111）分别通过柔性的定位线（107）连接。

Description

一种具有定位环的经导管输送主动脉瓣瓣膜装置 技术领域
本发明涉及医疗器械领域，尤其涉及一种具有定位环的经导管输送主动脉瓣瓣膜装置。
背景技术
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。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。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。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。
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。
发明内容
本发明的目的是提供一种具有定位环的经导管输送主动脉瓣瓣膜装置，该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或返流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的问题；进一步的，解决适应多种病症的问题，如主动脉瓣狭窄或关闭不全或返流或二瓣化等病症。
本发明提供一种具有定位环的经导管输送主动脉瓣瓣膜装置，所述主动脉 瓣瓣膜装置包括：主支架；固定在所述主支架中间部分内侧的瓣叶；及沿所述主支架内侧周边固定、并与所述瓣叶固定的裙边；其中，所述主支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上端有用于所述主支架的装载的三个上端圆形连接爪；所述主支架的底端有用于减少瓣周漏的向外扩张的下喇叭口结构；所述下喇叭口结构的下端有三个下端圆形连接爪；所述主动脉瓣瓣膜装置还包括位于所述主支架下侧的用于定位的定位环，所述定位环包括三个V字形或U字形圆弧段，各个所述V字形或U字形圆弧段的端部彼此相连形成环状，并在所述端部上形成三个定位圆形连接爪；所述下端圆形连接爪与相应的定位圆形连接爪分别通过柔性的定位线连接。
可选择地，所述主支架和/或所述定位环为镍钛合金材料；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。进一步说，下喇叭口结构为向外微扩张的平直喇叭口结构。下喇叭口结构高度为3mm到8mm。
可选择地，所述主支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主支架的中心轴线的倾角分别为1°到15°。
可选择地，所述上端圆形连接爪的中心为圆形或方形通孔或无孔形状，所述上端圆形连接爪与上喇叭口结构通过短连杆连接。
可选择地，所述主支架的中间部分与所述主支架的上喇叭口结构通过短连杆彼此连接。优选的，所述短连杆长度为1.5mm到4mm，宽度为0.25mm到1mm。
可选择地，所述主支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。所述左右内凹的短连杆的最小宽度为0.25mm到0.5mm。
可选择地，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。
可选择地，所述下端圆形连接爪的中间为圆孔或方孔，所述下端圆形连接爪的底端为内凹的圆弧结构；下端圆形连接爪均匀分布于主支架底端。
所述定位圆形连接爪的中间为圆孔或方孔，所述定位圆形连接爪的顶端为内凹的圆弧结构。
优选的，所述下端圆形连接爪底端内凹的圆弧大小为半径0.3mm到半径1mm。所述定位圆形连接爪顶端内凹的圆弧大小为半径0.3mm到半径1mm。
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；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。
可选择地，所述定位线为普通医用缝合线或可降解医用缝合线等高分子材料丝线或镍钛丝等金属丝状材料。
可选择地，所述定位环由3个到12个V字形或U字形结构单元构成，杆宽为0.3mm到1mm，所述定位环高度为7mm到15mm。
优选的，所述定位线的长度比所述定位环的高度增加5mm到12mm。
本发明的优点是通过在主动脉瓣瓣膜的主支架上端设置成喇叭口状结构末端的三个圆形连接爪，实现了主动脉瓣瓣膜装置的装载与回收；通过主支架底端的平直喇叭口形状，减少了瓣周漏；通过主支架下端的定位线及定位环，实现了主动脉瓣瓣膜装置的精确定位，从而使得手术过程更加安全可靠。
附图说明
图1是本发明的一种主动脉瓣瓣膜装置的展开状态示意图；
图2是本发明的一种主动脉瓣瓣膜装置的定位示意图；
图3是本发明的一种主动脉瓣瓣膜装置定位环结构示意图；
图4是本发明的主动脉瓣瓣膜装置装载至输送***的示意图；
图5是本发明的主动脉瓣瓣膜装置定位环半释放的示意图；
图6是本发明的主动脉瓣瓣膜装置定位环完全释放的示意图；
图7是本发明的主动脉瓣瓣膜装置输送到心脏位置示意图；
图8是本发明的主动脉瓣瓣膜装置在心脏位置定位环半释放示意图；
图9是本发明的主动脉瓣瓣膜装置在心脏位置定位环完全释放示意图；
图10是本发明的主动脉瓣瓣膜装置在心脏位置主支架定位示意图；
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。
具体实施方式
本发明提供一种具有定位环的经导管输送主动脉瓣瓣膜装置，该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或返流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的问题；进一步的，解决适应多种病症的问题，如主动脉瓣狭窄或关闭不全或返流或二瓣化等病症。
下面结合附图，对本发明实施例作进一步详细描述。
如图1到图3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返流而导致病变的原位主动脉瓣中，所述主动脉瓣瓣膜装置包括：主支架；固定在所述主支架中间部分内侧的瓣叶104；及沿所述主支架内侧周边固定、并与所述瓣叶104固定的裙边102；进一步说，裙边102沿主支架四周围 成一圈，并用缝合线缝合固定；瓣叶104为三片，缝于主支架中间部分，并与裙边102固定缝合。
参见图1，所述主支架的上端形成呈三瓣形式的上喇叭口结构105；在所述上喇叭口结构105上端有用于所述主支架的装载的三个上端圆形连接爪106，其可以为空心或者实心；所述主支架的底端有用于减少瓣周漏的向外扩张的下喇叭口结构101；所述下喇叭口结构101的下端有三个下端圆形连接爪110；所述主动脉瓣瓣膜装置还包括位于所述主支架下侧的用于定位的定位环103，所述定位环103包括三个V字形或U字形圆弧段，各个所述V字形或U字形圆弧段的端部彼此相连形成环状，并在所述端部上形成三个定位圆形连接爪111；所述下端圆形连接爪110与相应的定位圆形连接爪111分别通过柔性的定位线107连接。
所述主支架和所述定位环103可以为镍钛合金材料；所述中间部分为垂直段，所述下喇叭口结构101的开口程度小于所述上喇叭口结构105的开口程度。进一步说，下喇叭口结构101为向外微扩张的平直喇叭口结构。下喇叭口结构101高度为3mm到8mm。
所述主支架可以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105和下喇叭口结构101的末端偏离所述主支架的中心轴线的倾角分别为1°到15°。主支架中间部分与下喇叭口结构101和上喇叭口结构105平滑过渡。
所述上端圆形连接爪106的中心为圆形或方形通孔或无孔形状，所述上端圆形连接爪106与上喇叭口结构105通过短连杆连接。
参见图2，所述主支架的中间部分与所述主支架的上喇叭口结构105通过 短连杆108彼此连接。优选的，所述短连杆长度为1.5mm到4mm，宽度为0.25mm到1mm。
所述主支架的相邻的所述网格单元之间可以采用左右内凹的短连杆连接109。所述左右内凹的短连杆的最小宽度为0.25mm到0.5mm。
所述左右内凹的短连杆可以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。
所述下端圆形连接爪110的中间可以为圆孔或方孔，所述下端圆形连接爪110的底端为内凹的圆弧结构；下端圆形连接爪110均匀分布于主支架底端。
所述定位圆形连接爪111的中间为圆孔或方孔，所述定位圆形连接爪111的顶端有内凹的圆弧结构112(参见图3)。
所述下端圆形连接爪110底端内凹的圆弧大小为半径0.3mm到半径1mm。所述定位圆形连接爪111顶端内凹的圆弧大小为半径0.3mm到半径1mm。
所述瓣叶的材料可以为猪心包、牛心包、马心包或高分子材料聚四氟乙烯；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。
所述定位线107可以为普通医用缝合线或可降解医用缝合线等高分子材料丝线或镍钛丝等金属丝状材料。
另外，所述定位环103也可以由3个到12个V字形或U字形结构单元构成，杆宽为0.3mm到1mm，所述定位环103高度为7mm到15mm。
所述定位线107的长度可以比所述定位环103的高度增加5mm到12mm。
另外，上喇叭口结构105中部可以呈菱形状展开，上喇叭口结构105均匀分布于主支架四周。
本发明实施例所述的一种具有定位环的经导管输送主动脉瓣瓣膜装置工 作过程如下：
先将所述主动脉瓣瓣膜装置100(包括主支架和定位环103)通过一定装置压缩装载入输送***200的装载鞘202中(请参考图4)，输送***200包括头端201、装载鞘202和手柄203等。通过介入方式将输送***200输送到人体病变位置(请参考图7)。然后通过手柄203将输送***200的装载鞘202向后移动到固定位置，将所述主动脉瓣瓣膜装置100的定位环103半释放出来(请参考图5和图8)，此时由于所述主动脉瓣瓣膜装置100材料形状记忆特性，定位环103自动膨胀，形成喇叭口形状(请参考图5和图8)，再慢慢向心室方向推送输送***200，使得定位环103接触到人体自然瓣叶组织300的底部，停止推送输送***200。再通过手柄203将输送***200的装载鞘202再次向后移动到固定位置，使得定位环103完全从装载鞘202中释放出来，此时定位环103由于材料形状记忆特性，完全自动膨胀至最大尺寸(请参照图6和9)。继续向心室方向推送输送***200，使得装载鞘202越过人体自然瓣叶组织300，直到定位线107处于绷紧状态，输送***200也同时处于限位状态(请参照图10)，然后再通过手柄203慢慢向后移动装载鞘202，使得主支架的下喇叭口结构101慢慢从输送***200的装载鞘202中释放出来，由于所述主动脉瓣瓣膜装置100材料形状记忆特性，下喇叭口结构101自动膨胀至最大，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和定位环103之间(请参考图11)，所述主动脉瓣瓣膜装置100完成精确定位。再次通过输送***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和上端圆形连接爪106从装载鞘202中释放出来，由于所述主动脉瓣瓣膜装置100 材料的形状记忆特性，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)，输送***200与上端圆形连接爪106，最后撤出输送***200，所述主动脉瓣瓣膜装置100植入完成。
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。

Claims (10)

  1. 一种具有定位环的经导管输送主动脉瓣瓣膜装置，所述主动脉瓣瓣膜装置包括：主支架；固定在所述主支架中间部分内侧的瓣叶；及沿所述主支架内侧周边固定、并与所述瓣叶固定的裙边；其特征在于：所述主支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上端有用于所述主支架的装载的三个上端圆形连接爪；所述主支架的底端有用于减少瓣周漏的向外扩张的下喇叭口结构；所述下喇叭口结构的下端有三个下端圆形连接爪；所述主动脉瓣瓣膜装置还包括位于所述主支架下侧的用于定位的定位环，所述定位环包括三个V字形或U字形圆弧段，各个所述V字形或U字形圆弧段的端部彼此相连形成环状，并在所述端部上形成三个定位圆形连接爪；所述下端圆形连接爪与相应的定位圆形连接爪分别通过柔性的定位线连接。
  2. 根据权利要求1所述的主动脉瓣瓣膜装置，其特征在于：所述主支架和/或所述定位环为镍钛合金材料；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。
  3. 根据权利要求1所述的主动脉瓣瓣膜装置，其特征在于：所述主支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主支架的中心轴线的倾角分别为1°到15°。
  4. 根据权利要求1所述的主动脉瓣瓣膜装置，其特征在于：所述上端圆形连接爪的中心为圆形或方形通孔或无孔形状，所述上端圆形连接爪与上喇叭口结构通过短连杆连接。
  5. 根据权利要求1所述的主动脉瓣瓣膜装置，其特征在于：所述主支架的中间部分与所述主支架的上喇叭口结构通过短连杆彼此连接。
  6. 根据权利要求3所述的主动脉瓣瓣膜装置，其特征在于：所述主支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. 根据权利要求6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. 根据权利要求1所述的主动脉瓣瓣膜装置，其特征在于：所述下端圆形连接爪的中间为圆孔或方孔，所述下端圆形连接爪的底端为内凹的圆弧结构；
    所述定位圆形连接爪的中间为圆孔或方孔，所述定位圆形连接爪的顶端为内凹的圆弧结构。
  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；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. 根据权利要求1所述的主动脉瓣瓣膜装置，其特征在于：所述定位线为高分子材料丝线或镍钛丝材料。
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