WO2019119946A1 - 人工心脏瓣膜 - Google Patents
人工心脏瓣膜 Download PDFInfo
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- WO2019119946A1 WO2019119946A1 PCT/CN2018/110577 CN2018110577W WO2019119946A1 WO 2019119946 A1 WO2019119946 A1 WO 2019119946A1 CN 2018110577 W CN2018110577 W CN 2018110577W WO 2019119946 A1 WO2019119946 A1 WO 2019119946A1
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- WIPO (PCT)
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- leaflet
- valve
- fixing member
- heart valve
- prosthetic heart
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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
Definitions
- the invention relates to the field of medical instruments, and in particular to a prosthetic heart valve.
- the human heart includes four valves, including the mitral, tricuspid, aortic, and pulmonary valves.
- the mitral valve and the tricuspid valve are respectively located between the left and right atrium and the ventricle, the active valve is located in the left ventricular outflow tract, and the pulmonary valve is located in the right ventricular outflow tract.
- These valves act as a one-way valve to ensure one-way flow of blood.
- the mitral valve is open when the left atrium contracts, and the blood flows from the left atrium to the left ventricle; when the left ventricle contracts, the mitral valve closes, and blood flows from the left ventricle through the aortic valve. Pumped to the whole body.
- Valvular disease is usually divided into valvular stenosis and regurgitation. According to the severity of the patient's condition, two surgical treatment methods, repair and replacement, are often used clinically.
- repair and replacement are often used clinically.
- the surgeon retains the patient's own heart valve structure to the extent that the lesion is repaired and shaped.
- Heart valve replacement is often used when valvular lesions are severely incapable of repair.
- Heart valve replacement replaces the patient's own heart valve with a prosthetic heart valve.
- the structure of the prior art artificial heart valve 00 is generally divided into two parts: a support for supporting and fixing, called a flap 01; and a movement for opening and closing to allow blood flow
- the active unit that passes through and blocks the return flow is referred to as the leaflet 02.
- the leaflets are often made of bio-derived materials, but the bio-derived materials are prone to calcification, breakage, etc. After 5-10 years of implantation, the leaflets will undergo calcification, decay or fatigue damage, and patients often need re-surgery. How to improve the long-term durability of artificial biological valves is an important issue in the current industry research.
- the durability of artificial biological valves is closely related to the selection of biological tissues, chemical treatment, etc., as well as the structural design of the leaflets and the fixation between the leaflets and the valve holders.
- Unreasonable leaflet structure design or fixation method will cause excessive stress and strain at the local position of the valve during opening and closing, which will affect the long-term fatigue resistance of the valve.
- the suture of the leaflets is directly inserted through the leaflets 02 using a suture needle, and the leaflets 02 are sutured on the valve frame 01 by sutures.
- the leaflet 02 With the beating of the heart, under the push of blood, the leaflet 02 is constantly changing in the two positions A and B. In the long run, the suture of the leaflet will be torn and broken due to stress friction, and the overall durability of the valve 00 is lowered.
- the present invention provides a prosthetic heart valve comprising a valve holder and a leaflet fixed to the inside of the valve frame, the leaflet comprising a free edge and a fixed edge opposite the free edge, the leaflet passing through The fixed edge is connected to the valve holder, wherein the artificial heart valve further comprises a fixing member, the fixing member connects the fixed edge to the valve holder, and the fixing member and the valve holder Connected by stitches.
- the fixing member has opposite upper and lower ends, the upper end being connected to the fixed side, and the lower end being connected to the valve holder.
- the upper end portion is provided with a receiving groove, and a length of the receiving groove extends along a length direction of the upper end portion, and the receiving groove receives the fixed side.
- the lower end portion and the valve holder are fixedly connected by a suture.
- the upper end portion and the valve holder are fixedly connected by a suture.
- the lower end portion and the valve holder are fixedly connected by a suture.
- the upper end portion and the valve holder are fixedly connected by a suture.
- the fixed side is provided with a plurality of through holes through which the suture passes.
- the leaflets comprise three leaflets, three of which are integrally joined by sutures or glue bonds, or three of the leaflets are integrally formed.
- the fixing member and the valve holder are sutured by a seam stitching needle insertion method, a flat needle stitching needle insertion method, or a needle stitching needle insertion method.
- the artificial heart valve provided by the invention changes the suture manner in which the leaflet and the valve frame are in direct contact by providing a fixing member between the leaflet and the valve frame, so that the leaflet repeatedly opens and closes under the push of blood but is not easy to tear. Cracking and breakage improve the overall durability of the valve.
- FIG. 1 is a schematic view showing the structure of a prior art artificial heart valve
- FIG. 2 is a schematic view showing the structure of a leaflet suture in a prior art artificial heart valve
- Figure 3 is a schematic view showing the structure of the artificial heart valve of the present invention.
- FIG. 4 is a schematic view showing the structure of a leaflet according to an embodiment of the present invention.
- Figure 5 is a schematic view showing the structure of three leaflets shown in Figure 4 forming a leaflet, the leaflet being in a closed state;
- FIG. 6 is a schematic structural view of a fixing member according to an embodiment of the present invention.
- FIG. 7 is a schematic cross-sectional structural view of a fixing member according to an embodiment of the present invention.
- FIG. 8 is a schematic structural view of a fixing member and a leaflet after being connected according to an embodiment of the present invention
- FIG. 9 is a schematic view showing the structure of a leaflet sutured to a valve frame according to an embodiment of the present invention.
- Figure 10a is a schematic view of a stitching method according to an embodiment of the present invention.
- Figure 10b is a schematic view of a sewing method according to an embodiment of the present invention.
- Figure 10c is a schematic view of a stitching method according to an embodiment of the present invention.
- Figure 11 is a schematic view showing the structure of a leaflet according to an embodiment of the present invention.
- inflow end is the end of the blood flowing into the instrument
- outflow end is the end of the blood outflow device
- the prosthetic heart valve 10 of the present invention includes a valve holder 11 and a leaflet 12 secured to the inside of the valve holder 11, and has an inflow end 14 and an outflow end 15.
- the valve frame 11 is a hollow columnar structure having an inner wall and an outer wall and having openings at both ends, and is composed of a plurality of evenly arranged support structures.
- the valve frame 11 further includes a film (not shown) that covers the inner and outer walls thereof to prevent leakage of blood, and the film, the inner wall and the outer wall collectively constitute the side wall 13 of the valve frame 11.
- the leaflet 12 includes three leaflets 120.
- the leaflet 120 is made of a bio-derived material, and the bio-derived material may be a bovine pericardium or a pig pericardium.
- Each of the leaflets 120 has an irregular semicircular shape as a whole, and includes a free edge 121 and a fixed edge 122 opposite to the free edge 121.
- the free edge 121 and the fixed edge 122 are connected by two opposite connecting members 123.
- the fixed edge 122 is adjacent to the inflow end 14 and is connected to the valve holder 11 with the free edge 121 near the outflow end 15.
- Adjacent two leaflets 120 are joined by adjacent connectors 123 to surround the leaflets 12.
- three separate leaflets 120 are joined by sutures to form leaflets 12. It will be appreciated that in other embodiments, three separate leaflets 120 may also be joined to form the leaflets 12 by gluing.
- each leaflet 120 has a front surface 125 and a rear surface 126 opposite the front surface 125.
- the blood impacts the anterior surface 125 of the leaflet 120 such that the leaflet 12 is in an open state and blood can flow through the valve 10; when the blood impacts the posterior surface 126 of the leaflet 120, the leaflet 12 is at In the closed state, blood is prevented from flowing back into the valve 10 from the outflow end 15.
- the fixed side 122 of the embodiment is further provided with a plurality of through holes 14 through which the suture and the suture connected to the needle pass.
- the through hole 14 has a flat edge and a circular shape, which is processed by a non-contact processing such as laser cutting.
- the leaflets 12 of the present invention are connected to the side walls 13 of the valve holder 11 by fasteners 14 as shown in FIG.
- the fixing member 14 has an elongated sheet shape as a whole and has opposite upper end portions 141 and lower end portions 142.
- the upper end portion 141 is connected to the fixed side 122 of the leaflet 120, and the connection manner may be stitching or bonding.
- the lower end portion 142 is for connecting to the side wall 13.
- the material of the fixing member 14 has higher strength and better ductility, and the material thereof can be selected from PTFE, PA or ultra high molecular weight polyethylene.
- the thickness of the fixing member 14 is preferably in the range of 0.1 to 0.5 mm, and the width is preferably in the range of 2 to 3 mm.
- the fastener may also be curved and may preferably be curved in conformity with the contour of the fixed edge of the leaflet.
- the partial end surface of the upper end portion 141 of the fixing member is recessed toward the lower end portion 142 to form the receiving groove 143, as shown in FIG. More preferably, the length of the receiving groove 143 extends in the longitudinal direction of the upper end portion 141, and the width of the receiving groove 143 is just enough to accommodate the fixed side 122. That is, the cross-sectional shape of the fixing member 14 in the longitudinal direction perpendicular to the fixing member 14 is substantially U-shaped.
- the groove 143 of the fixing member 14 completely receives the fixing edge 122, and the upper end portion 141 completely covers the through hole 124, in order to facilitate understanding of the position of the upper end portion 141,
- the through hole 124 is still visible in 8.
- the fixing member 14 and the leaflet 120 are fixed to the side wall 13 by stitching.
- the suture passes only through the lower end portion 142 of the fixture 14, and the upper end portion 141 is movable relative to the lower end portion 142.
- the leaflets 12 are in a state of continuous opening and closing, and the upper end portion 141 is reciprocated. Since the material of the fixing portion 14 has higher strength and better ductility than the bio-sourced leaflets 13, the tearing and breakage of the suture of the lower end portion 142 is less likely to occur, and the fixed edge of the leaflet 120 is harder. 122 can still exercise, so the stress is small and it is not easy to break.
- the upper end portion of the fixing member may also be fixed to the side wall by a suture, and at this time, the suture is fixed to the side wall by the through hole path on the fixed side.
- the leaflets are partially fixed to the side walls, during the movement, the upper end of the fixing member acts as a transition, and the leaflets are still more difficult to tear and break.
- the upper end portion of the fixing member may not have a groove.
- the upper end portion of the fixing member and the fixed side 122 of the leaflet are connected by suture or glue bonding, and the lower end portion of the fixing member is fixed on the side wall by the suture, as long as the fixing member can play a transition role, the leaflet can be ensured It is more difficult to tear and break.
- the upper end portion of the fixing member can also be fixed to the side wall by a suture (for example, at this time, the fixing member is sandwiched between the leaflet and the leaf frame, that is, the leaflet and the fixing The surface of the piece is connected away from the surface of the valve frame.
- the upper end portion can also play a transitional role, and the leaflet can still be difficult to tear and break.
- the manner in which the fixing member 14 and the side wall 13 are sewn and the manner in which the fixing member 14 and the leaflet 12 are sewn may be sewn in any of the preferred manners as shown in Figs. 10a to 10c. Specifically, the lower stitching method will be described by taking the lower end portion 142 to the side wall 13 as an example.
- Figure 10a shows the stitching stitching mode. After the suture 16a passes through the lower end portion 142, it bypasses the lower edge of the fixing member 14, and then passes over the side wall 13, and then the needle insertion position at the lower end portion 142. The adjacent position is inserted into the needle and reciprocated until the entire leaflet slit 12 is joined to the side wall 13.
- Fig. 10b shows a flat needle stitching mode in which the suture 16b passes vertically through the lower end portion 142 and the side wall 13, sequentially feeding the needle.
- Figure 10c shows the stitching needle insertion mode. The suture 16c passes vertically through the lower end portion 142 and the side wall 13, and the needle insertion sequence is repeated twice in the adjacent two needle insertion holes.
- the needle is inserted, and each needle is inserted twice.
- the stitching is performed by stitching the needle into the needle. Compared with the other two needles, the stitching of the needle can increase the stitching strength of the fixed side, thereby enhancing the overall fatigue resistance of the valve 10.
- stitching such as splay stitching, parallel stitching, and the like.
- the leaflets 12a may also be integrally formed, that is, the three leaflets 120a are a unitary integral structure, and the leaflet structure can greatly reduce the risk of interlobular fracture, and the specific structure is as shown in FIG.
- valve holder can adopt other types of valve holders commonly used in the art.
- present invention is exemplified by a valve of a tricuspid valve as an example, and the technical solution of the present invention can also be applied to other artificial valves such as a mitral valve, an anastomosis, and the like.
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- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
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Abstract
一种人工心脏瓣膜（10），包括瓣架（11）以及固定于瓣架（11）内侧的瓣叶（12），瓣叶（12）包括自由边（121）和与自由边（121）相对的固定边（122），瓣叶（12）通过固定边（122）与瓣架（11）相连。人工心脏瓣膜（10）还包括固定件（14），固定件（14）将固定边（122）与瓣架（11）相连，固定件（14）与瓣架（11）之间通过缝线连接。通过在瓣叶（12）与瓣架（11）之间设置固定件（14），使得瓣叶（12）在血液的推动下反复打开和闭合但不会发生撕裂和破损，保证了瓣膜整体的耐久度。
Description
本发明涉及医疗器械领域，具体涉及一种人工心脏瓣膜。
人体心脏包括四个瓣膜，包括二尖瓣、三尖瓣、主动脉瓣和肺动脉瓣。其中二尖瓣、三尖瓣分别位于左右心房和心室之间，主动瓣膜位于左心室流出道，肺动脉瓣位于右心室流出道。这些瓣膜起到单向阀的作用，保证血液的单向流动。以二尖瓣为例，在一个心动周期过程中，左心房收缩时二尖瓣开放，血液由左心房流向左心室；当左心室收缩时，二尖瓣关闭，血液从左心室经主动脉瓣泵到全身。
瓣膜疾病通常分为瓣膜狭窄和关闭不全。根据患者病情的严重程度，临床上往往会采用修复和置换两种手术治疗方式。行瓣膜修复术时，外科医生最大程度保留患者的自有心脏瓣膜结构，对病变的部位进行修复塑形。当瓣膜病变严重无法行修复术时，往往采用心脏瓣膜置换术。心脏瓣膜置换术即采用人工心脏瓣膜替换患者的自有心脏瓣膜。
如图1，现有技术的人工心脏瓣膜00的结构一般分为两个部分：用于起支撑和固定作用的支架，称之为瓣架01；和用于实现打开和闭合动作，让血流通过以及阻止返流的活动单元，称之为瓣叶02。瓣叶往往采用生物源性材料制成，但生物源性材料容易出现钙化、破损等问题，在植入5-10年以后瓣叶会发生钙化、衰败或疲劳破损， 患者往往需要再次手术治疗。如何提高人工生物瓣膜的长期耐久性是目前行业内研究的一个重要问题。
人工生物瓣膜的耐久度除了与生物组织的选材、化学处理等密切相关以外，还与瓣叶的结构设计以及瓣叶与瓣架之间的固定方式有很大关系。不合理的瓣叶结构设计或固定方法，会造成瓣膜在打开和闭合过程中局部位置的应力应变过大，影响瓣膜的长期耐疲劳性能。如图2，现有技术中瓣叶的缝合方式为直接使用缝线针穿过瓣叶02，利用缝线将瓣叶02缝合在瓣架01上。随着心脏的跳动，在血液的推动下，瓣叶02在A和B两个位置不断变换，长此以往，瓣叶的缝线处会因应力摩擦发生撕裂和破损，瓣膜00整体耐久度降低。
发明内容
基于此，本发明提供了一种人工心脏瓣膜，包括瓣架以及固定于瓣架内侧的瓣叶，所述瓣叶包括自由边和与所述自由边相对的固定边，所述瓣叶通过所述固定边与所述瓣架相连，其特征在于，所述人工心脏瓣膜还包括固定件，所述固定件将所述固定边与所述瓣架相连，所述固定件与所述瓣架之间通过缝线连接。
在一实施例中，所述固定件具有相对的上端部和下端部，所述上端部与所述固定边相连，所述下端部与所述瓣架相连。
在一实施例中，所述上端部设有收容槽，所述收容槽长的长度沿所述上端部的长度方向延伸，所述收容槽收容所述固定边。
在一实施例中，所述下端部与所述瓣架之间通过缝线固定连接。
在一实施例中，所述上端部与所述瓣架之间通过缝线固定连接。
在一实施例中，所述下端部与所述瓣架之间通过缝线固定连接。
在一实施例中，所述上端部与所述瓣架之间通过缝线固定连接。
在一实施例中，所述固定边上设有多个供缝线穿过的通孔。
在一实施例中，所述瓣叶包括三个小叶，三个所述小叶通过缝线或者胶合粘结连接成一体，或者三个所述小叶一体成型。
在一实施例中，所述固定件与所述瓣架之间通过锁边缝合进针方式、平针缝合进针方式或者回针缝合进针方式缝合。本发明提供的人工心脏瓣膜，通过在瓣叶与瓣架之间设置固定件，改变了瓣叶与瓣架直接接触的缝合方式，使得瓣叶在血液的推动下反复打开和闭合但不易发生撕裂和破损，提高了瓣膜整体的耐久度。
图1为现有技术的人工心脏瓣膜结构示意图；
图2为现有技术的人工心脏瓣膜中瓣叶缝合方式结构示意图；
图3为本发明的人工心脏瓣膜结构示意图；
图4为本发明一实施例的小叶结构示意图；
图5为三个图4所示的小叶组合形成瓣叶的结构示意图，该瓣叶处于闭合状态；
图6为本发明一实施例的固定件结构示意图；
图7为本发明一实施例的固定件截面结构示意图；
图8为本发明一实施例固定件和小叶连接后的结构示意图；
图9为本发明一实施例的瓣叶缝合至瓣架结构示意图；
图10a为本发明一实施例的缝合方式示意图；
图10b为本发明一实施例的缝合方式示意图；
图10c为本发明一实施例的缝合方式示意图；
图11为本发明一实施例的瓣叶结构示意图。
为更好地理解本发明的有益效果，以下结合具体实施例对本发明的技术方案做进一步的说明。定义“流入端”为血液流入器械的一端，“流出端”为血液流出器械的一端。
参见图3至图5，本发明的人工心脏瓣膜10包括瓣架11以及固定于瓣架11内侧的瓣叶12，且具有一个流入端14和一个流出端15。瓣架11为有内壁和外壁且两端具有开口的中空柱状结构，由多个均匀排布的支撑结构组合而成。瓣架11还包括覆于其内壁和外壁上防止血液外漏的覆膜(图未示出)，且覆膜、内壁和外壁共同构成瓣架11的侧壁13。
瓣叶12包括三个小叶120。小叶120由生物源性材料制成，生物源性材料可选为牛心包或猪心包。每个小叶120整体呈非规则半圆形，包括一个自由边121以及与自由边121相对的固定边122，自由边121与固定边122之间通过两个相对的连接件123相连。固定边122靠近流入端14且与瓣架11相连，自由边121靠近流出端15。相邻的两个小叶120通过毗邻的连接件123连接,以围绕组成瓣叶12。在本实施例中，三个独立的小叶120通过缝线连接组成瓣叶12。可以理解的是，其它实施例中，三个独立的小叶120也可以通过胶合粘结的方式连接 组成瓣叶12。
如图5所示，每个小叶120具有前表面125和与前表面125相对的后表面126。当血液从流入端14流入瓣膜10时，血液冲击小叶120的前表面125，使得瓣叶12处于打开状态，血液得以流过瓣膜10；当血液冲击小叶120的后表面126时，瓣叶12处于闭合状态，禁止血液从流出端15反流入瓣膜10。
为方便缝合且避免穿针形成的裂缝延展，优选地，本实施例的固定边122上还设有多个供缝针及连于缝针上的缝线穿过的通孔14。通孔14边缘平整，形状优选为圆形，其通过激光切割等非接触式加工方式加工而成。
本发明的瓣叶12与瓣架11的侧壁13之间通过图6所示的固定件14相连。固定件14整体呈长形片状，具有相对的上端部141和下端部142。上端部141与小叶120的固定边122相连，连接方式可选为缝合或粘接。下端部142用以与侧壁13相连。相较于瓣膜12，固定件14的材料具有较高的强度和较好的延展性，其材料可选为PTFE、PA或超高分子量聚乙烯等。固定件14的厚度优选范围为0.1～0.5mm，宽度优选范围为2～3mm。
在其它实施例中，固定件也可为弧形片状，可优选为与瓣叶固定边轮廓一致的弧形。
进一步地，为使小叶120与固定件14连接更稳固，优选地，本实施例的固定件上端部141的部分端面向下端部142凹陷形成收容槽143，如图7所示。更优选地，收容槽143的长度沿上端部141长度 方向延伸，收容槽143的宽度恰好能容纳固定边122。即固定件14在垂直于固定件14的长度方向上的截面形状大致呈U形。
参见图8，当固定件14与小叶120连接后，固定件14的槽143完全收容固定边122，且上端部141完全覆于通孔124上，为方便理解上端部141所处的位置，图8中仍保留通孔124可见。
如图9所示，将固定件14与固定边122固定后，利用缝线将固定件14和小叶120固定至侧壁13上。在本实施例中，缝线仅穿过固定件14的下端部142，上端部141可相对下端部142活动。本实施例的瓣膜10植入体内之后，在血液的冲击下，瓣叶12处于不停地打开和闭合的运动状态，连带上端部141往复运动。由于固定部14的材料相较于生物源性的瓣叶13具有较高的强度和较好的延展性，下端部142的缝线处也较难发生撕裂和破损，而小叶120的固定边122仍可发生运动，因此应力小也不易产生破损。
在其它实施例中，固定件的上端部也可一并通过缝线固定至侧壁上，此时，缝线按照固定边上的通孔路径将上端部和固定边也固定于侧壁上。虽然这种实施例下，瓣叶被部分固定于侧壁上，但在运动过程中，固定件的上端部起到了过渡作用，依旧能保证瓣叶较难发生撕裂和破损。
在其它实施例中，固定件的上端部也可不开设槽。此时，固定件的上端部与小叶的固定边122通过缝线或者胶合粘结相连，固定件的下端部通过缝线固定在侧壁上，只要固定件能起到过渡作用，能保证瓣叶较难发生撕裂和破损即可。
可以理解的是，在其它实施例中，固定件的上端部亦可通过缝线固定在侧壁上(例如，此时，固定件夹设在小叶与瓣架之间，也就是说小叶与固定件的远离瓣架的表面相连)，此时，上端部也可起到过渡作用，依旧能保证瓣叶较难发生撕裂和破损。
以上固定件14与侧壁13的缝合方式以及固定件14与瓣叶12的缝合方式可以采用如图10a至图10c中的优选的任一方式缝合。具体地，以将下端部142缝合至侧壁13为例来介绍下缝合方式。
图10a所示为锁边缝合进针方式，缝线16a穿过下端部142后，绕过固定件14的下缘，再穿至侧壁13上，之后再在下端部142前一个进针位置的相邻位置进针，循环往复，直至将整个瓣叶缝12合至侧壁13上。图10b所示为平针缝合进针方式，缝线16b垂直穿过下端部142和侧壁13，顺序进针。图10c所示为回针缝合进针方式，缝线16c垂直穿过下端部142和侧壁13，在相邻两个进针孔依次重复进针两次后，再向下一进针孔顺序进针，每个进针孔均进针两次。本实施例优选为以回针缝合进针方式进行缝合，相对于另两种进针方式，回针缝合进针可以提升固定边的缝合强度，从而增强瓣膜10的整体抗疲劳性能。
可以理解的是，在其它实施例中，也可以采用其它的缝合方式进行缝合，例如八字缝合、平行缝合等。
同样地，在其它实施例中，瓣叶12a还可以一体成型，即三个小叶120a是一体的完整结构，这种瓣叶结构能大大降低小叶间断裂的风险，具体结构如图11所示。
以上实施例仅为本发明的优选实施例，并非对本发明的限制，本发明的保护范围以权利要求为准。本领域的技术人员可根据实际需求，对相应结构做更换，例如，瓣架可以采用本领域常用的其它类型的瓣架。同样，本发明仅以三尖瓣的瓣膜为例进行举例说明，本发明的技术方案同样可用于其它如二尖瓣、动脉瓣等其它人工瓣膜。
Claims (10)
- 一种人工心脏瓣膜，包括瓣架以及固定于瓣架内侧的瓣叶，所述瓣叶包括自由边和与所述自由边相对的固定边，所述瓣叶通过所述固定边与所述瓣架相连，其特征在于，所述人工心脏瓣膜还包括固定件，所述固定件将所述固定边与所述瓣架相连，所述固定件与所述瓣架之间通过缝线连接。
- 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述固定件具有相对的上端部和下端部，所述上端部与所述固定边相连，所述下端部与所述瓣架相连。
- 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述上端部设有收容槽，所述收容槽的长度沿所述上端部的长度方向延伸，所述收容槽收容所述固定边。
- 根据权利要求3所述的人工心脏瓣膜，其特征在于，所述下端部与所述瓣架之间通过缝线固定连接。
- 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述上端部与所述瓣架之间通过缝线固定连接。
- 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述下端部与所述瓣架之间通过缝线固定连接。
- 根据权利要求6所述的人工心脏瓣膜，其特征在于，所述上端部与所述瓣架之间通过缝线固定连接。
- 根据权利要求1至7中任一项所述的人工心脏瓣膜，其特征在于，所述固定边上设有多个供缝线穿过的通孔。
- 根据权利要求1至7中任一项所述的人工心脏瓣膜，其特征在于，所述瓣叶包括三个小叶，三个所述小叶通过缝线或者胶合粘结连接成一体，或者三个所述小叶一体成型。
- 根据权利要求1至7中任一项所述的人工心脏瓣膜，其特征在于，所述固定件与所述瓣架之间通过锁边缝合进针方式、平针缝合进针方式或者回针缝合进针方式缝合。
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| WO1998051239A1 (en) * | 1997-05-13 | 1998-11-19 | Medical Carbon Research Institute, Llc | Trileaflet heart valve |
| CN202223386U (zh) * | 2011-08-11 | 2012-05-23 | 北京市普惠生物医学工程有限公司 | 具有一体式瓣叶的生物心脏瓣膜 |
| CN202568532U (zh) * | 2008-06-06 | 2012-12-05 | 爱德华兹生命科学公司 | 可植入的人工瓣膜 |
| WO2017011697A1 (en) * | 2015-07-14 | 2017-01-19 | Edwards Lifesciences Corporation | Prosthetic heart valve |
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| US7399315B2 (en) * | 2003-03-18 | 2008-07-15 | Edwards Lifescience Corporation | Minimally-invasive heart valve with cusp positioners |
| US8425593B2 (en) * | 2007-09-26 | 2013-04-23 | St. Jude Medical, Inc. | Collapsible prosthetic heart valves |
| US8568475B2 (en) * | 2010-10-05 | 2013-10-29 | Edwards Lifesciences Corporation | Spiraled commissure attachment for prosthetic valve |
| KR101525921B1 (ko) * | 2014-02-17 | 2015-06-04 | (주) 태웅메디칼 | 인공심장판막 및 그 제조방법 |
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| WO1998051239A1 (en) * | 1997-05-13 | 1998-11-19 | Medical Carbon Research Institute, Llc | Trileaflet heart valve |
| CN202568532U (zh) * | 2008-06-06 | 2012-12-05 | 爱德华兹生命科学公司 | 可植入的人工瓣膜 |
| CN202223386U (zh) * | 2011-08-11 | 2012-05-23 | 北京市普惠生物医学工程有限公司 | 具有一体式瓣叶的生物心脏瓣膜 |
| WO2017011697A1 (en) * | 2015-07-14 | 2017-01-19 | Edwards Lifesciences Corporation | Prosthetic heart valve |
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