WO2014101676A1 - 一种假体瓣膜及假体瓣膜装置 - Google Patents

一种假体瓣膜及假体瓣膜装置 Download PDF

Info

Publication number
WO2014101676A1
WO2014101676A1 PCT/CN2013/089425 CN2013089425W WO2014101676A1 WO 2014101676 A1 WO2014101676 A1 WO 2014101676A1 CN 2013089425 W CN2013089425 W CN 2013089425W WO 2014101676 A1 WO2014101676 A1 WO 2014101676A1
Authority
WO
WIPO (PCT)
Prior art keywords
leaf
skirt
lobes
prosthetic valve
edge
Prior art date
Application number
PCT/CN2013/089425
Other languages
English (en)
French (fr)
Inventor
王约翰
齐均
雷荣军
张启明
Original Assignee
杭州启明医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 杭州启明医疗器械有限公司 filed Critical 杭州启明医疗器械有限公司
Publication of WO2014101676A1 publication Critical patent/WO2014101676A1/zh

Links

Images

Classifications

    • 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
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present invention relates to a prosthetic valve, and more particularly to a prosthetic valve and a prosthetic valve device.
  • Heart valve replacement has become a routine surgical solution for patients with valvular insufficiency or calcification stenosis.
  • Existing treatments are still surgical, although some procedures can be achieved through the use of minimally invasive techniques (so-called "keyhole" technology
  • keyhole minimally invasive techniques
  • the vast majority of valve replacement still requires thoracotomy for patients, and the cardiopulmonary bypass is used to stop the heartbeat.
  • this surgical thoracotomy is already a mature surgical method, the trauma caused to the patient is enormous. A lot of rest time is required, and many life-threatening complications occur during the process.
  • Percutaneous interventional therapy has attracted more and more attention because of its small trauma and light injury. Through unremitting efforts, many problems encountered in the repair of diseased valves by percutaneous interventional prosthetic heart valves have been resolved.
  • the method is specifically as follows: the artificial heart valve prosthesis is first compressed, and placed in a delivery sheath tube, and then opened in the femoral artery of the human body, and the delivery sheath tube is passed through the opening and sent to the desired valve position through the human blood vessel. Finally released.
  • the shape and configuration of the artificial heart prosthetic valve is often dependent on the biological shape and size of the valve to which the valve is adapted (ie, the mitral, tricuspid, aortic, or pulmonary valve).
  • prosthetic heart valves are designed to have the function of the original valve, so they all include a leaflet structure.
  • the prosthetic valve can include a vascular segment with a lobed segment that is also mounted in some manner in the expandable stent to form a stented prosthetic heart valve device.
  • a prosthetic valve device is disclosed in U.S. Patent No. 7,914,569, the disclosure of which is incorporated herein by reference to FIG. 3A, FIG. 3B, FIG. 4B and FIG.
  • the prosthetic valve of the patent includes a leaf skirt 1a.
  • the leaf skirt 1a is an annular structure in which a plurality of leaf skirt units 11a are sequentially formed.
  • the leaf skirt 1a has a notch 13a formed on one side edge thereof, and the boundary of the notch 13a is a leaf flap.
  • the fixed side 131a is sewn with a leaflet 2a at the fixed edge 131a of the leaflet 13a.
  • the splicing between the two-leaf skirt unit 11a is currently fixed by manual stitching.
  • the splicing line 111a between the two spliced leaf skirt units 11a is intersected by the two notches 13a (ie, the skirt 1a)
  • the highest point extends to the position of the bottom edge 12a, which inevitably increases the length required for manual stitching.
  • the longer the stitching length the more the number of stitches, and the probability of error is undoubtedly also The bigger.
  • the sutured prosthetic valve i.e., the leaf skirt 1a
  • the positions on the circumference of the suture 111a overlapping each other will reach nine positions, as shown in Fig. 2, i.e., I to VIII.
  • the present invention provides a prosthetic valve with less stitching and higher safety required for suturing.
  • a prosthetic valve comprising a leaf skirt which is sequentially spliced into a ring structure by a plurality of leaf skirt units, wherein the leaf skirt is provided with a plurality of notches, and the positions of the notches are correspondingly provided with lobes, the boundaries of the notches
  • the adjacent leaf skirt pieces are connected by a splicing line, one end of the splicing line intersects the fixed edge of the lobes, and the other end intersects perpendicularly to the bottom edge of the leaf skirt along a straight line.
  • the fixed edge of the leaflet is an arc.
  • the splicing line is located at a fixed point on the fixed side of the lobes in a line between one quarter and three quarters of the fixed side of the lobes.
  • the position on the fixed side of the leaflet intersecting the splicing line is the position on the fixed side of the lobes closest to the bottom edge of the leaf skirt.
  • the intersection of the splicing line on the fixed side of the lobes is one-half of the fixed side of the lobes.
  • each leaflet corresponds to one splicing line.
  • the number of the leaf skirt unit pieces is two or three.
  • the beneficial effect of the invention is that the stitching boundary when the adjacent two leaf skirt unit pieces are mutually stitched is a splicing line, and the splicing line is from the fixed edge of the leaf lobes to the bottom edge of the leaf skirt, and the splicing line is fixed along the lobes
  • the stitching line of the present invention is the shortest relative to the conventional stitching line, and therefore, the number of stitches to be stitched when stitching the stitching thread is also minimized, thereby reducing the number of stitches during manual stitching. The risks brought about and the safety of use.
  • the present invention provides a valve device that is simple in construction, safer, and requires fewer needles when suturing the attached prosthetic valve.
  • the technical solution of the present invention is: a prosthetic valve device comprising a stent and a prosthetic valve connected to the stent, the prosthetic valve being the prosthetic valve.
  • the prosthetic valve is manually sutured on the stent, because the suture on the prosthetic valve is arranged in the shortest manner, thereby reducing the risk of manual suturing and ensuring that the valve stent is safely installed in place. More sexual.
  • Figure 1 is a schematic view of the structure of a U.S. patented leaf skirt and leaflet combination.
  • Figure 2 is a schematic view showing the structure of the U.S. patent leaf skirt in an unfolded state.
  • Figure 3 is a schematic view showing the structure of a US patented leaflet.
  • Figure 4 is a schematic view showing the structure of the leaf skirt and the leaflet of Figure 1 after suturing.
  • FIG. 5 is a schematic structural view of a blade skirt unit according to an embodiment of the present invention.
  • Fig. 6 is a structural schematic view showing the unfolded state of a leaf skirt according to an embodiment of the present invention.
  • FIG. 7 is a schematic structural view of a combination of a leaf skirt and a leaflet according to an embodiment of the present invention.
  • Figure 8 is a schematic view showing the structure of the leaf skirt and the leaflet of Figure 7 after suturing.
  • Fig. 9 is a structural schematic view showing the unfolded state of the two-leaf skirt according to the embodiment of the present invention.
  • FIG. 10 is a schematic structural view of a three-open state according to an embodiment of the present invention.
  • FIG. 11 is a schematic structural diagram of a collapsed state according to Embodiment 3 of the present invention.
  • the present embodiment includes a leaf skirt 1 which is sequentially formed into a ring structure by three blade skirt unit pieces 11.
  • the leaf skirt 1 of the annular structure has upper and lower edges, wherein the lower edge is
  • the bottom edge 12 has three indentations 13 arranged in the upper edge.
  • the boundary of each of the notches 13 is correspondingly provided with a leaflet 2, and the fixed edge 131 of the blade is an arc structure.
  • Two ends of the splicing line 111 between the adjacent leaf skirts 11 are respectively located at the fixed edge 131 of the lobes and the bottom edge 12 of the skirt 1.
  • the splicing line 111 is along the fixed edge 131 of the lobes and the bottom edge 12 of the skirt 1
  • the fixed edge 131 of the blade can also be other forms of lines, even irregular curves. Although the technical feature of the irregular curve has no application significance in practical applications, it also falls within the protection scope of the present invention.
  • the two adjacent leaf skirt unit pieces 11 are stitched by means of needle stitching, and the stitching limit when stitching each other is the stitching line 111 (the stitching line 111 is not stitched for suturing), and the stitching line 111 is a straight line. And one end of the straight line intersects the fixed edge 131 of the leaflet, and the other end intersects perpendicularly to the bottom edge 12 of the skirt 1 in a straight line.
  • the point at which the stitching line 111 and the fixed side 131 of the leaf are connected is defined as an intersection point 14, which is 14
  • the position closest to the bottom edge 12 of the skirt 1 is such that the splicing line 111 is the shortest path between the lobed fixed edge 131 and the bottom edge 12 of the skirt 1.
  • the leaf skirt 1 of the annular structure is formed by splicing three leaf skirt unit pieces 11, and the notches 13 on each of the two leaf skirt unit pieces 11 are spliced to form a fixed edge 131 of the leaflet, and the splicing line is formed.
  • 111 is the shortest path between the fixed edge 131 of the blade and the bottom edge 12 of the skirt 1.
  • the fixed edge 131 of the leaflet is a centrally symmetrical arc
  • the intersection 14 of the splicing line 111 and the fixed edge 131 of the lobes is one-half of the fixed edge 131 of the lobes, so the fixed edge 131 of the lobes here.
  • the position closest to the bottom edge 12 of the skirt 1 is the closest.
  • the fixed edge 131 of the leaflet is a centrally symmetrical arc, and if the fixed edge 131 of the blade is a non-central symmetrical arc, the intersection 14 of the splicing line 111 and the fixed edge 131 of the lobes may be located at the lobes.
  • the quarter of the fixed side 131 is between one quarter and three quarters (the quarter to three quarters is calculated by the length of the fixed edge 131 of the leaf), and the fixed edge 131 of the leaf
  • the intersection 14 that intersects the splicing line 111 is the position on the lobed fixed edge 131 that is closest to the bottom edge 12 of the skirt 1.
  • a transition edge 112 for stitching is extended between the two adjacent leaf skirting pieces 11, which is also extremely commonly used in the existing sewing field. means.
  • the skirt 15 for suturing with the bracket 3 is regularly extended on the bottom edge 12 of the skirt 1 , and the skirt 15 is tooth-shaped and arranged equidistantly. When stitching, the skirts 15 are covered. On the mesh branch of the stent 3, the skirt 15 is then sutured to the corresponding mesh branch by a needle thread, thereby achieving fixation of the skirt 15 on the stent 3.
  • the second embodiment is as shown in FIG. 9.
  • the number of the splicing lines 111 is two, and the number of the lobes 2 is also two. 1 is formed by splicing two pieces of two leaf skirt pieces 11, and the two splicing lines 111 are distributed along the shortest path between the fixed edge 131 of the blade and the bottom edge 12 of the skirt 1.
  • the splicing line 111 on the prosthetic valve is raised from the fixed edge 131 of the leaflet to the bottom edge 12 of the skirt 1.
  • the splicing line 111 is along the fixed edge 131 and the bottom of the skirt 1
  • the shortest path distribution between the rims 12, the stitching line 111 of the present invention is the shortest relative to the conventional splicing line, and therefore, the number of stitches to be stitched when stitching the splicing line 111 is also minimized, thereby reducing the number of stitches during manual stitching. The risks brought about and the safety of use.
  • intersection 14 of the splicing line 111 and the fixed edge 131 of the lobes is one-half of the fixed edge 131 of the lobes, clearly indicating the position of the center point of the fixed side of the lobes, so that the lobes connected to the lobes are positioned.
  • a clear reference point makes the manual stitching process more controlled.
  • the splicing line 111 on the prosthetic valve is shorter, thereby reducing the risk of manual suturing and ensuring a higher safety after the valve device is installed.
  • a third embodiment mounts a prosthetic valve in a frame of an expandable stent 3 to form a prosthetic valve device with a stent 3, and the leaf skirt 1 of the prosthetic valve can be sutured.
  • the manner is fixed on the bracket 3, and the stitched boundary is carried out along the contour of the skirt 1 , that is, the fixed edge 131 , the bottom edge 12 and the skirt 15 on the skirt 1 , thereby realizing the skirt 1 and the bracket 3 fixed.
  • the splicing line 111 provides another positional marking for the valve to be mounted within the stent.
  • the wiring 111 shown in Figure 10 mates with a diamond shaped cell of the stent to provide a clearer alignment of the valve with the stent.
  • the direction of the notch in the skirt 1 is the direction in which the blood flows out
  • the direction in which the bottom edge 12 faces is the direction in which the blood flows.
  • the prosthetic valve device is compressed, as shown in Figure 11, the stent 3 and the prosthetic valve are axially compressed together.
  • the overlapping suture segments A to E at the fixed edge 131 of the leaf are only six, and the cross-sectional area of the reduced transition edge and the folded transition edge is very obvious.
  • the friction between the compressed valve prosthesis device and the delivery sheath is greatly reduced, and the large diameter stented prosthetic valve device can be compressed to a smaller diameter, and the corresponding delivery sheath diameter is also The reduction not only reduces the damage to the patient, but also provides a solution for many patients with vascular calcification stenosis.
  • prosthetic valve in the present valve device can also adopt the structure in the second embodiment, and these structures fall within the protection scope of the present invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic 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)

Abstract

一种假体瓣膜包括由若干叶裙单元片（11）依次拼接成环形结构的叶裙（1），叶裙（1）上设有若干缺口（13），各缺口（13）所在位置对应地设有叶瓣（2），各缺口（13）的边界为叶瓣固定边（131），相邻两叶裙单元片（11）之间相互缝合时的缝合界限为拼接线（111），相邻叶裙单元片（11）之间的拼接线（111）的两端分别位于叶瓣固定边（131）和叶裙（1）的底缘（12）处，拼接线（111）沿该叶瓣固定边（131）与叶裙（1）的底缘（12）之间的最短路径分布。相比于现有技术中的拼接线，该拼接线（111）是最短的，使得缝合拼接线（111）时所需缝合的针数也最少，降低人工缝合所带来的风险，提高使用安全性。

Description

一种假体瓣膜及假体瓣膜装置 技术领域
本发明涉及一种假体瓣膜，尤其是一种假体瓣膜及一种假体瓣膜装置。
 背景技术
心脏瓣膜置换术已成为一种常规的解决患者瓣膜关闭不全或钙化狭窄手术方案，现有的治疗手段仍为外科手术，虽然某些程序可以通过使用微创技术(即所谓的“钥匙孔”技术)，但绝大多数瓣膜置换术仍需要对患者进行开胸手术，实施体外循环停止心跳，虽然此外科开胸手术方式已经是一个成熟的手术方法，但其对患者造成的创伤是巨大的，需要大量的休养时间，而且过程中会产生许多危急生命的并发症。
经皮介入治疗方法，因其创伤小、伤害轻，而得到越来越多人的关注。经不懈努力，现已解决经皮介入人工心脏瓣膜修复病变瓣膜时会遇到的多项问题。该方法具体操作如下：先将人工心脏瓣膜假体压缩，并将其放入输送鞘管中，然后在人体股动脉上开口，输送鞘管通过该开口，经人体血管送入所需瓣膜位置，最后释放。
人工心脏假体瓣膜的形状和构造往往是取决于所适用修复的瓣膜的人体生物形状和尺寸(即，二尖瓣、三尖瓣、主动脉瓣或肺动脉瓣)。一般来说，假体心脏瓣膜的设计都是为了使其具备原有瓣膜的功能，所以均包括有叶瓣结构。根据人体生物结构，假体瓣膜可包括带叶瓣的血管段，该血管段还以某种方式安装在可扩张支架内形成一个带支架的假体心脏瓣膜装置。
如图1-4所示，公开号为US7914569的美国专利中就公开了一种假体瓣膜装置，图中包括了美国专利中的图FIG.3A、FIG.3B、FIG.4B和FIG.5，该专利中的假体瓣膜包括叶裙1a，叶裙1a为若干叶裙单元11a依次拼成的环形结构，叶裙1a其中一侧缘上开设有缺口13a，该缺口13a的边界为叶瓣固定边131a，该缺口13a内的叶瓣固定边131a处缝合有叶瓣2a。
鉴于生物瓣膜植入后患者无需永久使用抗凝药物的特点，假体瓣膜采用生物材料已是减少患者术后痛苦的优选方法，而生物组织若面积过大，其质量不稳定性必然增加，该专利中将叶裙1a小单元块化，降低了对生物原材料的要求；同时，该专利中叶瓣2a和叶裙1a的缝接结构使叶瓣2a单元在受到血流冲击时，施加到其与叶裙1a接合边缘的力均匀分布，而不是集中在某个局部的结合点，从而进一步提高了假体生物瓣膜的抗疲劳性能。
但是，目前两叶裙单元11a间的拼接是通过人工缝合的方式进行固定的，上述专利中，两拼接的叶裙单元11a间的拼接线111a由两缺口13a缘相交点(即叶裙1a的最高点)延伸至底缘12a位置，而这无形中增加了需要人工缝合的长度，对于如此高要求的人工缝合产品，缝合长度越长，缝合针数则越多，而出现误差的几率无疑也越大。同时，如若对该缝合后的假体瓣膜(即叶裙1a)进行轴向压缩，其圆周上的缝合线111a相互重叠的位置将达九处，如图2所示，即I～VIIII处。每一处缝合线111a缝合时所需要的折叠层所产生的压缩截面积，在一个以F(1French＝1/3mm)为直径计量单位的介入鞘管内产生的影响是非常明显的。对于患者来说，尺寸越小的鞘管对身体的伤害会越小，能够适用该治疗的患者范围也将越广。
 技术问题
为了克服现有技术的不足，本发明提供了一种缝合所需针数少，安全性更高的假体瓣膜。
 技术解决方案
本发明技术方案是：一种假体瓣膜，包括由若干叶裙单元依次拼接成环形结构的叶裙，叶裙上设有若干缺口，各缺口所在位置对应地设有叶瓣，各缺口的边界为叶瓣固定边，相邻叶裙单元片之间通过拼接线相连，该拼接线的一端相交于叶瓣固定边，另一端沿直线垂直相交于叶裙底缘。
优选设置是：所述叶瓣固定边为弧线。
优选设置是：所述拼接线位于叶瓣固定边上的交点为叶瓣固定边上四分之一至四分之三间的连线内。
优选设置是：所述叶瓣固定边上与拼接线相交的位置为叶瓣固定边上距离叶裙底缘最近的位置。
优选设置是：所述拼接线位于叶瓣固定边上的交点为叶瓣固定边的二分之一处。
优选设置是：每条叶瓣固定边均对应一条拼接线。
优选设置是：所述叶裙单元片的数量为两个或三个。
本发明的有益效果是：相邻两叶裙单元片间相互缝合时的缝合界限即为拼接线，该拼接线由叶瓣固定边起至叶裙底缘止，拼接线沿该叶瓣固定边与叶裙底缘之间的最短路径分布，相对于传统拼接线而言，本发明的拼接线是最短的，因此，也使得缝合拼接线时所要缝合的针数也最少，进而降低人工缝合时所带来的风险，提高使用安全性。
为了克服现有技术的不足，本发明提供了一种结构简单，安全性更高，且与所附带的假体瓣膜缝合时所需针数少的瓣膜装置。
本发明技术方案是：一种假体瓣膜装置，包括支架和与支架连接的假体瓣膜，所述假体瓣膜为所述的假体瓣膜。
 有益效果
本发明的有益效果是：假体瓣膜被人工缝合于支架上，因为假体瓣膜上的缝合线以最短的方式布置，从而降低了人工缝合时所带来的风险，保证瓣膜支架安装到位后安全性更高。
 附图说明
图1为美国专利叶裙和叶瓣组合的结构示意图。
图2为美国专利叶裙展开状态的结构示意图。
图3为美国专利叶瓣的结构示意图。
图4为图1中叶裙和叶瓣缝合后的结构示意图。
图5为本发明实施例一叶裙单元片的结构示意图。
图6为本发明实施例一叶裙展开状态的结构示意图。
图7为本发明实施例一叶裙和叶瓣组合后的结构示意图。
图8为图7中叶裙和叶瓣缝合后的结构示意图。
图9为本发明实施例二叶裙展开状态的结构示意图。
图10为本发明实施例三张开状态的结构示意图。
图11为本发明实施例三收拢状态的结构示意图。
 本发明的实施方式
下面结合附图对本发明作进一步描述：
第一种实施例：如图5-6所示，本实施例包括由三片叶裙单元片11依次拼成环形结构的叶裙1，环形结构的叶裙1具有上下缘，其中下缘为底缘12，上缘上开设有三个依次设置的缺口13，各缺口13的边界为叶瓣固定边131对应地设有叶瓣2，该叶瓣固定边131为弧线结构。相邻叶裙单元片11之间的拼接线111的两端分别位于叶瓣固定边131和叶裙1底缘12处，拼接线111沿该叶瓣固定边131与叶裙1底缘12之间的最短路径分布。当然，该叶瓣固定边131也可以为其他形式的线，甚至为不规则的曲线，虽然不规则曲线这一技术特征，在实际应用中并没有应用意义，但是也落于本发明的保护范围内。
两相邻叶裙单元片11之间通过针线缝合的方式进行拼接，且相互缝合时的缝合界限即为拼接线111(该拼接线111非缝合用的缝合线)，该拼接线111为直线，且该直线的一端相交于叶瓣固定边131，另一端沿直线垂直相交于叶裙1底缘12，定义拼接线111与叶瓣固定边131上相连接的点为交点14，该交点14为与叶裙1底缘12距离最近的位置，由此使得该拼接线111为叶瓣固定边131与叶裙1底缘12之间的最短路径。
如图7、8所示，环形结构的叶裙1由三片叶裙单元片11拼接而成，每两个叶裙单元片11上的缺口13拼接后形成一条叶瓣固定边131，拼接线111为叶瓣固定边131和叶裙1底缘12间的最短路径。本实施例中，叶瓣固定边131为中心对称圆弧，拼接线111与叶瓣固定边131的交点14为叶瓣固定边131的二分之一处，故此处也即叶瓣固定边131上与叶裙1底缘12距离最近的位置。当将两相邻叶裙单元片11通过此处进行缝合时，所缝出的拼接线111最短。
上述实施例中，叶瓣固定边131为中心对称的圆弧，而如果叶瓣固定边131为非中心对称的弧线，则拼接线111与叶瓣固定边131的交点14，可以位于叶瓣固定边131上四分之一至四分之三间的连线内(该处四分之一至四分之三是以叶瓣固定边131的长度来计算的)，且叶瓣固定边131上与拼接线111相交的交点14为叶瓣固定边131上距离叶裙1底缘12最近的位置。
为了便于两相邻叶裙单元片11间的缝合，所以两相邻叶裙单元片11间会延伸出用于缝合用的过渡缘112，该过渡缘112在现有的缝合领域也是极其常用的手段。
另外，在叶裙1的底缘12还规则地延伸出用于与支架3缝合用的裙脚15，该裙脚15呈齿状且依次等距排布，缝合时，各裙脚15包覆于支架3的网状支脉上，然后通过针线将裙脚15缝合于相应的网状支脉上，从而实现裙脚15在支架3上的固定。
第二种实施例：如图9所示，相对于第一种实施例而言，本实施例中拼接线111的数量为两条，叶瓣2数量也为两个，则环形结构的叶裙1由两片两片叶裙单元片11拼接而成，两条拼接线111沿叶瓣固定边131与叶裙1底缘12之间的最短路径分布。
本发明实施例一和实施例二中，假体瓣膜上的拼接线111由叶瓣固定边131起至叶裙1底缘12止，拼接线111沿该叶瓣固定边131与叶裙1底缘12之间的最短路径分布，相对于传统拼接线而言，本发明的拼接线111是最短的，因此，也使得缝合拼接线111时所要缝合的针数也最少，进而降低人工缝合时所带来的风险，提高使用安全性。同时，拼接线111与叶瓣固定边131的交点14为叶瓣固定边131的二分之一处，清晰的标明了瓣固定边的中心点位置，使与叶裙连接的叶瓣定位有了明确的参照点，使手工缝合过程更加受控。
较传统的瓣膜装置而言，本瓣膜装置中，假体瓣膜上的拼接线111更短，从而降低了人工缝合时所带来的风险，保证瓣膜装置安装到位后安全性更高。
第三种实施例：如图10所示，本实施例将假体瓣膜安装于可扩张的支架3框内制成带支架3的假体瓣膜装置，假体瓣膜的叶裙1可通过缝合的方式固定于支架3上，所缝合的边界是沿着叶裙1的轮廓线进行的，即叶裙1上的叶瓣固定边131、底缘12和裙脚15，从而实现叶裙1和支架3间的固定。拼接线111为瓣膜安装在支架内提供了另一个位置标记，图10中所示接线111就与支架的一个菱形单元格配合，使制作人员对瓣膜与支架的配合位置更加清晰。一般而言，当叶裙1安设于支架3内时，叶裙1上缺口所朝方向为血流流出的方向，而底缘12所朝方向则为血流流进的方向。
使用时，需将压缩该假体瓣膜装置，如图11所示，支架3和假体瓣膜一并轴向压缩。并结合图7所示，叶瓣固定边131处的重合的缝合线段A～E仅为6条，随之减少的缝线和折叠的过渡缘的截面积是非常明显的。大大减少了压缩的瓣膜假体装置和输送鞘管之间的摩擦力，并且使大直径的带支架的假体瓣膜装置，能够压缩到更小的直径，所对应的输送鞘管直径也随之减小，不仅减少了对病人的伤害，对于很多血管钙化狭窄的病人带来了解决方案。
当然，本瓣膜装置中的假体瓣膜还可以采用实施例二中的结构，且这些结构均落入本发明的保护范围内。

Claims (8)

  1. 一种假体瓣膜，包括由若干叶裙单元依次拼接成环形结构的叶裙，叶裙上设有若干缺口，各缺口所在位置对应地设有叶瓣，各缺口的边界为叶瓣固定边，其特征是：相邻叶裙单元片之间通过拼接线相连，该拼接线的一端相交于叶瓣固定边，另一端沿直线垂直相交于叶裙底缘。
  2. 根据权利要求1所述的假体瓣膜，其特征是：所述叶瓣固定边为弧线。
  3. 根据权利要求2所述的假体瓣膜，其特征是：所述拼接线位于叶瓣固定边上的交点为叶瓣固定边上四分之一至四分之三间的连线内。
  4. 根据权利要求3所述的假体瓣膜，其特征是：所述叶瓣固定边上与拼接线相交的位置为叶瓣固定边上距离叶裙底缘最近的位置。
  5. 根据权利要求2所述的假体瓣膜，其特征是：所述拼接线位于叶瓣固定边上的交点为叶瓣固定边的二分之一处。
  6. 根据权利要求1所述的假体瓣膜，其特征是：每条叶瓣固定边均对应一条拼接线。
  7. 根据权利要求1所述的假体瓣膜，其特征是：所述叶裙单元片的数量为两个或三个。
  8. 一种假体瓣膜装置，包括支架和与支架连接的假体瓣膜，其特征是：所述假体瓣膜为权利要求1～7任一所述的假体瓣膜。
PCT/CN2013/089425 2012-12-24 2013-12-13 一种假体瓣膜及假体瓣膜装置 WO2014101676A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201210566977.0A CN103006352B (zh) 2012-12-24 2012-12-24 一种假体瓣膜及假体瓣膜装置
CN201210566977.0 2012-12-24

Publications (1)

Publication Number Publication Date
WO2014101676A1 true WO2014101676A1 (zh) 2014-07-03

Family

ID=47955828

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2013/089425 WO2014101676A1 (zh) 2012-12-24 2013-12-13 一种假体瓣膜及假体瓣膜装置

Country Status (2)

Country Link
CN (1) CN103006352B (zh)
WO (1) WO2014101676A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109966023A (zh) * 2017-12-28 2019-07-05 上海微创心通医疗科技有限公司 心脏瓣膜假体及其支架

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103006352B (zh) * 2012-12-24 2015-05-13 杭州启明医疗器械有限公司 一种假体瓣膜及假体瓣膜装置
DE102014223522A1 (de) * 2014-11-18 2016-05-19 Hans-Hinrich Sievers Biologische Herzklappenprothese
US9974650B2 (en) * 2015-07-14 2018-05-22 Edwards Lifesciences Corporation Prosthetic heart valve
CN105342725B (zh) * 2015-11-27 2017-11-03 金仕生物科技（常熟）有限公司 人工生物心脏瓣膜支架和人工生物心脏瓣膜
CN108245281A (zh) * 2016-12-28 2018-07-06 上海微创心通医疗科技有限公司 瓣膜假体
US10973628B2 (en) * 2017-08-18 2021-04-13 Edwards Lifesciences Corporation Pericardial sealing member for prosthetic heart valve
WO2019042455A1 (zh) * 2017-09-04 2019-03-07 杭州启明医疗器械有限公司 一种裙边褶皱的支架装置以及加工方法、裙边褶皱方法、心脏瓣膜
WO2021068788A1 (zh) * 2019-10-08 2021-04-15 杭州启明医疗器械股份有限公司 改进的心脏瓣膜的瓣叶以及心脏瓣膜预制品、心脏瓣膜和加工方法
CN114052988A (zh) * 2020-08-07 2022-02-18 山前(珠海)生物材料科技有限公司 一种心脏瓣膜组件及其制备方法
CN112957092B (zh) * 2021-02-05 2022-12-09 郑州蓝跃生物科技股份有限公司 一种支气管单向活瓣支架

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) * 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US20060259136A1 (en) * 2005-05-13 2006-11-16 Corevalve Sa Heart valve prosthesis and methods of manufacture and use
CN102113921A (zh) * 2009-12-30 2011-07-06 微创医疗器械(上海)有限公司 一种介入式心脏瓣膜
CN102202610A (zh) * 2008-10-29 2011-09-28 西美蒂斯股份公司 用于支架瓣膜制造和组装的方法和系统
WO2012032187A1 (en) * 2010-09-10 2012-03-15 Symetis Sa Valve replacement devices, delivery device for a valve replacement device and method of production of a valve replacement device
CN103006352A (zh) * 2012-12-24 2013-04-03 杭州启明医疗器械有限公司 一种假体瓣膜及假体瓣膜装置

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5935163A (en) * 1998-03-31 1999-08-10 Shelhigh, Inc. Natural tissue heart valve prosthesis
KR20120004677A (ko) * 2010-07-07 2012-01-13 (주) 태웅메디칼 이종생체조직을 이용한 인공심장판막 및 제조방법

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) * 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US20060259136A1 (en) * 2005-05-13 2006-11-16 Corevalve Sa Heart valve prosthesis and methods of manufacture and use
CN102202610A (zh) * 2008-10-29 2011-09-28 西美蒂斯股份公司 用于支架瓣膜制造和组装的方法和系统
CN102113921A (zh) * 2009-12-30 2011-07-06 微创医疗器械(上海)有限公司 一种介入式心脏瓣膜
WO2012032187A1 (en) * 2010-09-10 2012-03-15 Symetis Sa Valve replacement devices, delivery device for a valve replacement device and method of production of a valve replacement device
CN103006352A (zh) * 2012-12-24 2013-04-03 杭州启明医疗器械有限公司 一种假体瓣膜及假体瓣膜装置

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109966023A (zh) * 2017-12-28 2019-07-05 上海微创心通医疗科技有限公司 心脏瓣膜假体及其支架

Also Published As

Publication number Publication date
CN103006352B (zh) 2015-05-13
CN103006352A (zh) 2013-04-03

Similar Documents

Publication Publication Date Title
WO2014101676A1 (zh) 一种假体瓣膜及假体瓣膜装置
US11865001B2 (en) Cardiac valve downsizing device and method
US20200337836A1 (en) Valve Leaflet Attachment in Collapsible Prosthetic Valves
JP5264264B2 (ja) 交換用心臓弁およびその製造方法
WO2018145249A1 (zh) 用于治疗三尖瓣反流的装置及其植入方法
CN106175986B (zh) 一种瓣膜夹合器
CN104274259B (zh) 一种带瓣叶夹持装置的人工瓣膜假体
AU2004233848B2 (en) Artificial valve prosthesis with improved flow dynamics
CN107233146A (zh) 适用心脏二尖瓣和三尖瓣带瓣支架置换瓣膜
CN109561961A (zh) 一种人工瓣膜及人工瓣膜植入方法
CN103491900A (zh) 用于二尖瓣修复和替换的系统
CN106420114A (zh) 一种心脏瓣膜假体
CN109414322A (zh) 一种人工瓣膜
JP2008264553A5 (zh)
CN106344213A (zh) 一种非对称的心脏瓣膜假体
CN108024863A (zh) 包括向冠状动脉提供血流的通道的支架组件以及递送和部署这种支架组件的方法
US10583008B2 (en) Devices and implantation methods for treating mitral valve conditions
JP2014524814A (ja) 心臓弁の置換
US20200030096A1 (en) Devices and implantation methods for treating mitral valve condition
CN107595436A (zh) 一种瓣膜夹合器
CN103202735B (zh) 肺动脉瓣膜置换装置及其支架
WO2018045797A1 (zh) 覆膜支架及其制备方法
CN108245281A (zh) 瓣膜假体
WO2023164239A1 (en) Transcatheter valve introducer system and methods
CN215584477U (zh) 一种裙边型人工机械心脏瓣膜

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13866692

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13866692

Country of ref document: EP

Kind code of ref document: A1