技术领域Technical field
本申请涉及医疗器械领域，具体涉及一种可避免交界处反流的瓣膜假体。This application relates to the field of medical devices, and specifically to a valve prosthesis that can avoid junction regurgitation.
背景技术Background technique
从心脏结构来看，无论是二尖瓣还是三尖瓣，均具有特殊的生理结构，造成产品准确定位和固定非常困难。尤其二尖瓣在心内的位置及其复杂的解剖结构给二尖瓣置换带来极大的挑战。From the perspective of heart structure, both the mitral valve and the tricuspid valve have special physiological structures, making it very difficult to accurately position and fix the product. In particular, the location of the mitral valve within the heart and its complex anatomical structure pose great challenges to mitral valve replacement.
二尖瓣关闭不全可分为慢性与急性二尖瓣关闭不全。慢性二尖瓣关闭不全大多是由风湿热造成的瓣叶损害、先天畸形和二尖瓣环钙化等原因引起。急性二尖瓣关闭不全多因腱索断裂、瓣膜毁损或破裂，乳头肌坏死或断裂以及人工瓣膜替换术后开裂而引起。Mitral regurgitation can be divided into chronic and acute mitral regurgitation. Chronic mitral regurgitation is mostly caused by valve leaflet damage caused by rheumatic fever, congenital malformations and mitral valve ring calcification. Acute mitral regurgitation is mostly caused by chordae tendineae rupture, valve damage or rupture, papillary muscle necrosis or rupture, and dehiscence after artificial valve replacement surgery.
随着主动脉瓣介入治疗技术的日趋成熟，众多公司开始进入二尖瓣介入治疗领域。自2012年6月12日丹麦哥本哈根大学附属医院完成世界首例人体经导管二尖瓣置换术以来，二尖瓣病治疗进入了一个新时代。TMVR是一种使用经导管介入的治疗方法，将人工瓣膜在体外压缩并装载至输送系统，沿着血管路径或经心尖送达二尖瓣瓣环处，之后释放并固定在二尖瓣瓣环内替代病变瓣膜。目前，此方法仅在外科手术有禁忌的二尖瓣返流患者中作探索性研究。自世界首例人体TMVR植入至今，大约有20余种TMVR用瓣膜处于研究中，有7种已经进入临床试验阶段。因二尖瓣复合体的解剖结构更为复杂，比如二尖瓣瓣环是马鞍形，且不在同一平面；二尖瓣环质地柔软，无法提供瓣膜假体径向支撑；二尖瓣靠近左心室流出道，瓣膜假体过长易导致左心室流出道梗阻等。所以，国际上还未有成熟产品问世。As aortic valve interventional treatment technology becomes increasingly mature, many companies have begun to enter the field of mitral valve interventional treatment. Since the completion of the world's first human transcatheter mitral valve replacement surgery at Copenhagen University Hospital in Denmark on June 12, 2012, the treatment of mitral valve disease has entered a new era. TMVR is a treatment method that uses transcatheter intervention. The artificial valve is compressed outside the body and loaded into the delivery system. It is delivered to the mitral valve annulus along the vascular path or transcardially apex, and is then released and fixed on the mitral valve annulus. Internal replacement of diseased valves. Currently, this method is only used in exploratory research in patients with mitral regurgitation who have contraindications for surgery. Since the world's first human TMVR implantation, more than 20 types of TMVR valves are under research, and 7 types have entered the clinical trial stage. Because the anatomical structure of the mitral valve complex is more complex, for example, the mitral valve annulus is saddle-shaped and not in the same plane; the mitral valve annulus is soft and cannot provide radial support for the valve prosthesis; the mitral valve is close to the left ventricle Outflow tract, valve prosthesis that is too long can easily lead to left ventricular outflow tract obstruction. Therefore, there are no mature products available internationally yet.
专利201711467178.7涉及一种心脏瓣膜假体及其支架。该支架沿着轴线方向包括流入道、流出道以及位于所述流入道和所述流出道之间的过渡区域；所述流出道包括环状结构和至少两个沿着轴线方向延伸形成的外凸结构；所述至少两个外凸结构分别与所述环状结构的远离所述过渡区域的一端连接；相邻的所述外凸结构之间限定空缺区域。该专利方案设置外凸结构，并且相邻的外凸结构之间设有空隙，前瓣叶位于该空隙区域，避免遮挡左室流出道，但从附图结构中能看出，支架在植入后，其前瓣叶依旧被支架挡在流出道的位置，只不过前瓣叶的尖端部分在瓣膜关闭时可以横向摆动，减少对流出道的遮挡，但该设计方案效果不好、依旧不能完美结构流出道的遮挡问题，并且圆筒形的支架在植入后会导致前瓣叶和后瓣叶被拨开，从而导致交界处的反流压力很大，瓣叶交界处很容易发生反流。Patent 201711467178.7 relates to a heart valve prosthesis and its stent. The stent includes an inflow channel, an outflow channel, and a transition area between the inflow channel and the outflow channel along the axial direction; the outflow channel includes an annular structure and at least two outer protrusions extending along the axial direction. Structure; the at least two protruding structures are respectively connected to one end of the annular structure away from the transition area; a vacant area is defined between adjacent protruding structures. This patent solution is provided with a convex structure, and there is a gap between adjacent convex structures. The front leaflet is located in the gap area to avoid blocking the left ventricular outflow tract. However, it can be seen from the structure of the attached figure that the stent is implanted during implantation. Afterwards, the front leaflet is still blocked by the stent in the outflow tract, but the tip of the front leaflet can swing laterally when the valve is closed, reducing the obstruction of the outflow tract. However, this design solution is not effective and is still not perfect. The structure's outflow tract is blocked, and the cylindrical stent will cause the anterior and posterior valve leaflets to be pushed apart after implantation, resulting in high regurgitation pressure at the junction, and regurgitation at the junction of the valve leaflets is easy to occur. .
而现有技术中大多都采用圆筒形的支架，虽然其圆筒形的支架便于缝制瓣叶假体，但是圆筒形的支架在植入后会导致前瓣叶与后瓣叶被支架拨开，而瓣叶交界处本身有凹陷处，这会导致在交界处其血液反流的压力非常大，并且，圆筒形的支架在植入后，前瓣叶被挂在流出道一侧，从而造成左室流出道的梗阻，对主动脉的血流产生严重影响。Most of the existing technologies use cylindrical stents. Although the cylindrical stent is convenient for sewing valve leaflet prostheses, the cylindrical stent will cause the anterior and posterior valve leaflets to be stented after implantation. The valve leaflet junction itself has a depression, which will cause the pressure of blood reflux at the junction to be very large. Moreover, after the cylindrical stent is implanted, the front valve leaflet is hung on the side of the outflow tract. , thus causing obstruction of the left ventricular outflow tract and seriously affecting the blood flow of the aorta.
综上所述尽管以上技术在临床上都有一些成效，但是都存在不足，亟需一种新的可避免交界处反流的瓣膜假体来解决以上问题。In summary, although the above technologies have some clinical results, they all have shortcomings. A new valve prosthesis that can avoid junction regurgitation is urgently needed to solve the above problems.
发明内容Contents of the invention
鉴于以上和其它构思，而提出了本申请。本申请的主要目的是克服现有技术的一些问题和不足。In view of the above and other concepts, the present application is proposed. The main purpose of this application is to overcome some problems and deficiencies of the prior art.
在房室瓣手术的应用方面，本申请旨在针对房室瓣出现病变且需要介入治疗的患者提供一种可避免交界处反流的瓣膜假体，从而可解决现有技术中瓣膜假体在植入后，自体瓣叶交界处仍存在较为严重的反流以及流出道梗阻等问题。In terms of the application of atrioventricular valve surgery, this application aims to provide a valve prosthesis that can avoid junction regurgitation for patients with atrioventricular valve disease and need interventional treatment, thereby solving the problem of valve prostheses in the existing technology. After implantation, problems such as severe regurgitation and outflow tract obstruction still exist at the junction of the autologous valve leaflets.
根据本申请的一方面，提供了一种可避免交界处反流的瓣膜假体，包括：外层支架、设置在外层支架内的瓣膜支架以及固定在瓣膜支架内的人工瓣叶，所述外层支架包括密封装置以及心室段，所述密封装置位于心房内，所述心室段上设置有第一夹合组件和第二夹合组件，所述第一夹合组件和第二夹合组件被构造成用于捕捉并夹合相邻的自体瓣叶，其中，当所述外层支架安装就位后，所述心室段位于前瓣叶区域的一侧向后瓣叶区域的一侧凹陷，所述第一夹合组件和第二夹合组件分别位于或靠近自体瓣叶交界处的两侧，并且，所述第一夹合组件和第二夹合组件分别夹合相邻的自体瓣叶，使得相邻自体瓣叶之间的距离被缩小。According to one aspect of the present application, a valve prosthesis that can avoid reflux at the junction is provided, comprising: an outer layer stent, a valve stent arranged in the outer layer stent, and an artificial valve leaflet fixed in the valve stent, the outer layer stent comprising a sealing device and a ventricular segment, the sealing device is located in the atrium, the ventricular segment is provided with a first clamping component and a second clamping component, the first clamping component and the second clamping component are configured to capture and clamp adjacent autologous valve leaflets, wherein when the outer layer stent is installed in place, the ventricular segment is located on a side of the anterior valve leaflet region and is recessed toward a side of the posterior valve leaflet region, the first clamping component and the second clamping component are respectively located on or near both sides of the junction of the autologous valve leaflets, and the first clamping component and the second clamping component respectively clamp adjacent autologous valve leaflets, so that the distance between adjacent autologous valve leaflets is reduced.
作为本发明的进一步改进，所述第一夹合组件和第二夹合组件结构类似，并且，所述第一夹合组件包括2根用于夹持自体瓣叶的刚性杆件，当所述外层支架植入时，2根刚性杆件分别捕捉前瓣叶和后瓣叶，在捕捉到前瓣叶和后瓣叶时，2根刚性杆件向着自体瓣叶对合边缘牵拉，使得自体瓣叶交界处区域的瓣叶聚拢，从而针对性填补自体瓣叶交界处的凹陷区域，有效避免血液反流。As a further improvement of the present invention, the first clamping component and the second clamping component have similar structures, and the first clamping component includes two rigid rods for clamping the autologous valve leaflets. When the outer stent is implanted, the two rigid rods capture the anterior and posterior valve leaflets respectively. When the anterior and posterior valve leaflets are captured, the two rigid rods pull toward the joining edges of the autogenous valve leaflets, so that The leaflets in the junction area of the autologous valve leaflets gather together to specifically fill the depressed area at the junction of the autologous valve leaflets and effectively avoid blood reflux.
作为本发明的进一步改进，在所述外层支架安装就位后，所述第一夹合组件和第二夹合组件分别带动相邻的自体瓣叶向着自体瓣叶对合边缘牵拉。As a further improvement of the present invention, after the outer stent is installed in place, the first clamping component and the second clamping component respectively drive the adjacent autologous valve leaflets to pull toward the overlapping edges of the autologous valve leaflets.
作为本发明的进一步改进，在自然形态下，所述外层支架的心室段设有第一凸起部和第二凸起部，并且，在所述外层支架安装就位后，所述第一凸起部和第二凸起部分别位于自体瓣叶的交界处。As a further improvement of the present invention, in a natural form, the ventricular segment of the outer stent is provided with a first protruding part and a second protruding part, and after the outer stent is installed in place, the third protruding part A convex part and a second convex part are respectively located at the junction of the native valve leaflets.
作为本发明的进一步改进，在所述第一夹合组件和第二夹合组件捕捉并夹合相邻的自体瓣叶后，所述心室段在自体瓣叶交界处形成有第一凸起部和第二凸起部。As a further improvement of the present invention, after the first clamping component and the second clamping component capture and clamp adjacent autologous valve leaflets, the ventricular segment is formed with a first protrusion at the junction of the autologous valve leaflets. and a second raised portion.
作为本发明的进一步改进，所述第一凸起部和第二凸起部被构造为适于填补自体瓣叶交界区域的形态。As a further improvement of the present invention, the first protruding part and the second protruding part are configured in a shape suitable for filling the interface area of the autologous valve leaflets.
作为本发明的进一步改进，所述第一凸起部和第二凸起部用于填补自体瓣叶交界处凹陷区域的部分较为柔软，能自适应贴合生理组织。As a further improvement of the present invention, the portions of the first convex portion and the second convex portion used to fill the recessed area at the junction of the autologous valve leaflets are relatively soft and can adaptively fit physiological tissues.
作为本发明的进一步改进，在所述外层支架安装就位后，所述外层支架的横截面呈半月形态。As a further improvement of the present invention, after the outer bracket is installed in place, the cross section of the outer bracket takes a half-moon shape.
作为本发明的进一步改进，所述第一夹合组件和第二夹合组件均被构造为能够呈现第一形态和第二形态；其中，当所述第一夹合组件和第二夹合组件处于第一形态时，所述第一夹合组件和第二夹合组件分别捕捉相邻的自体瓣叶；其中，当所述第一夹合组件和第二夹合组件处于第二形态时，所述第一夹合组件和第二夹合组件分别带动相邻的自体瓣叶向自体瓣叶对合边缘牵拉；其中，当所述第一夹合组件和第二夹合组件处于第二形态时，所述第一夹合组件和第二夹合组件分别带动相邻的自体瓣叶向自体瓣叶对合边缘牵拉。As a further improvement of the present invention, the first clamping component and the second clamping component are both constructed to be able to present a first form and a second form; wherein, when the first clamping component and the second clamping component are in the first form, the first clamping component and the second clamping component respectively capture adjacent autologous leaflets; wherein, when the first clamping component and the second clamping component are in the second form, the first clamping component and the second clamping component respectively drive the adjacent autologous leaflets to be pulled toward the corresponding edges of the autologous leaflets; wherein, when the first clamping component and the second clamping component are in the second form, the first clamping component and the second clamping component respectively drive the adjacent autologous leaflets to be pulled toward the corresponding edges of the autologous leaflets.
作为本发明的进一步改进，所述第一夹合组件和第二夹合组件呈“V”字形结构设置，当所述第一夹合组件和第二夹合组件由第一形态转换为第二形态时，其“V”字形的2个端部逐渐聚拢，并带动相邻的自体瓣叶向自体瓣叶对合边缘牵拉。As a further improvement of the present invention, the first clamping component and the second clamping component are arranged in a "V" shape structure. When the first clamping component and the second clamping component are converted from the first form to the second form, When the valve is in the original shape, the two ends of the "V" shape gradually come together, and drive the adjacent autologous valve leaflets to pull toward the joining edges of the autologous valve leaflets.
作为本发明的进一步改进，所述瓣膜假体还包括收缩调节装置，所述收缩调节装置分别与所述第一夹合组件和第二夹合组件可拆卸连接，其中，当所述第一夹合组件和第二夹合组件捕捉到自体瓣叶后，操作所述收缩调节装置使得所述第一夹合组件和第二夹合组件分别带动相邻的自体瓣叶向自体瓣叶对合边缘牵拉。As a further improvement of the present invention, the valve prosthesis also includes a contraction adjustment device, which is detachably connected to the first clamping component and the second clamping component respectively, wherein when the first clamping component and the second clamping component capture the native leaflets, the contraction adjustment device is operated so that the first clamping component and the second clamping component respectively drive the adjacent native leaflets to be pulled toward the corresponding edges of the native leaflets.
作为本发明的进一步改进，所述收缩调节装置为线控装置，利用拉线来控制第一夹合组件（或是第二夹合组件）的刚性杆件之间的距离。As a further improvement of the present invention, the contraction adjustment device is a wire-controlled device, using a pull wire to control the distance between the rigid rods of the first clamping component (or the second clamping component).
作为本发明的进一步改进，所述瓣膜支架的中心与自体瓣膜的中心不重合，并且，所述瓣膜支架的中心靠近后瓣叶区域。As a further improvement of the present invention, the center of the valve stent does not coincide with the center of the native valve, and the center of the valve stent is close to the posterior valve leaflet area.
作为本发明的进一步改进，所述心室段为网格支架，并且，所述心室段上设有空白区域，并且，该空白区域在心室段上的形态大体呈“U”形结构，在所述外层支架安装就位后，所述空白区域位于前瓣叶区域；当自体瓣膜开闭时，其前瓣叶依旧能摆动，并且在自体瓣膜关闭时，前瓣叶位于所述的空白区域，这样能有效减少。As a further improvement of the present invention, the ventricular segment is a grid stent, and a blank area is provided on the ventricular segment, and the shape of the blank area on the ventricular segment is generally a "U"-shaped structure. After the outer stent is installed in place, the blank area is located in the front leaflet area; when the native valve opens and closes, the front leaflet can still swing, and when the native valve closes, the front leaflet is located in the blank area. This can effectively reduce it.
作为本发明的进一步改进，所述密封装置包括支撑段以及贴靠段，在所述外层支架安装就位后，所述支撑段位于前瓣叶区域，并且所述支撑段至少抵靠心房臂，所述贴靠段位于后瓣叶区域并贴合邻近的心房组织，支撑段能让瓣膜假体整体向后瓣叶区域贴靠，使其最大限度地减少其瓣膜假体对左室流出道的遮挡。As a further improvement of the present invention, the sealing device includes a support section and an abutment section. After the outer stent is installed in place, the support section is located in the front leaflet area, and the support section at least abuts against the atrial arm. , the contact section is located in the posterior valve leaflet area and fits the adjacent atrial tissue. The support section allows the valve prosthesis to be attached to the posterior valve leaflet area as a whole, thereby minimizing the impact of the valve prosthesis on the left ventricular outflow tract. of occlusion.
与现有技术相比，本申请的优点和有益技术效果至少包含以下所列：Compared with the existing technology, the advantages and beneficial technical effects of this application include at least the following:
1.现有的瓣膜支架为了便于缝制人工瓣叶，大多都设计成圆筒形（支架在心室内的部分），而圆筒形的支架在植入后会导致前瓣叶和后瓣叶被拨开，增大了前、后瓣叶在交界处的距离，并且，由于自体瓣叶交界处区域的组织是凹陷形态，从而导致交界处的反流压力很大，瓣叶交界处很容易发生反流，同时，圆筒形的支架还会将前瓣叶隔挡在流出道的位置，影响主动脉瓣膜的血流供应；区别于现有技术，在本申请的一实施例中，外层支架的心室段位于前瓣叶区域的一侧向后瓣叶区域的一侧凹陷，使得外层支架在植入后，其前瓣叶依旧能开闭摆动，有效避免对左室流出道的阻挡，并且外层支架对前瓣叶没有强力的隔挡，避免增大前、后瓣叶在交界处的距离，减小交界处的反流压力，同时，在交界处又设有第一夹合组件和第二夹合组件，使其牵拉相邻的自体瓣叶向着自体瓣叶对合边缘牵拉，从而使得自体瓣叶交界处区域的瓣叶聚拢，针对性填补自体瓣叶交界处的凹陷区域，有效避免血液反流，同时也能为瓣膜支架提供锚定空间以及锚定力，避免瓣膜支架径向支撑自体瓣环，破坏自体瓣膜的形态，有效避免术后并发症。1. In order to facilitate the sewing of artificial valve leaflets, most of the existing valve stents are designed to be cylindrical (the part of the stent in the ventricle), and the cylindrical stent will cause the anterior valve leaflet and the posterior valve leaflet to be separated after implantation, increasing the distance between the anterior and posterior valve leaflets at the junction. In addition, since the tissue in the junction area of the native valve leaflets is concave, the reflux pressure at the junction is very large, and reflux is likely to occur at the junction of the valve leaflets. At the same time, the cylindrical stent will also block the anterior valve leaflet in the outflow tract, affecting the blood supply of the aortic valve. Different from the prior art, in one embodiment of the present application, the ventricular segment of the outer stent is located on one side of the anterior valve leaflet area and is concave toward the side of the posterior valve leaflet area, so that the outer stent After implantation, the anterior leaflet can still open and close and swing, effectively avoiding obstruction of the left ventricular outflow tract, and the outer stent has no strong barrier to the anterior leaflet, avoiding increasing the distance between the anterior and posterior leaflets at the junction and reducing the reflux pressure at the junction. At the same time, a first clamping component and a second clamping component are provided at the junction to pull the adjacent native leaflets toward the corresponding edges of the native leaflets, thereby bringing the leaflets together in the junction area of the native leaflets and specifically filling the recessed area at the junction of the native leaflets, effectively avoiding blood reflux, and at the same time providing anchoring space and anchoring force for the valve stent, avoiding the valve stent from radially supporting the native valve ring and destroying the morphology of the native valve, effectively avoiding postoperative complications.
2.区别于现有技术，在本申请的一实施例中，外层支架的心室段设有第一凸起部和第二凸起部，并且，在外层支架安装就位后，第一凸起部和第二凸起部分别位于自体瓣叶的交界处，这样设计的目的在于：第一凸起部和第二凸起部既能有效填补到交界处的凹陷区域，减少血液的反流，又能将瓣膜假体整体向后瓣叶区域贴靠，最大限度地减少对左室流出道的阻挡。2. Different from the prior art, in one embodiment of the present application, the ventricular segment of the outer stent is provided with a first protruding part and a second protruding part, and after the outer stent is installed in place, the first protruding part The raised part and the second raised part are respectively located at the junction of the native valve leaflets. The purpose of this design is that the first raised part and the second raised part can effectively fill the recessed area at the junction and reduce the reflux of blood. , and can place the whole valve prosthesis close to the posterior leaflet area, minimizing the obstruction to the left ventricular outflow tract.
3.区别于现有技术，在本申请的一实施例中，瓣膜假体由外层支架和瓣膜假体组成，其外层支架在植入后呈半月形结构，既能有效减少左室流出道的阻挡，又能减少瓣膜支架的规格，便于规模化量产。3. Different from the existing technology, in one embodiment of the present application, the valve prosthesis is composed of an outer stent and a valve prosthesis. The outer stent has a half-moon structure after implantation, which can effectively reduce left ventricular outflow. The obstruction of the duct can also reduce the specifications of the valve stent and facilitate large-scale mass production.
4.区别于现有技术，在本申请的一实施例中，密封装置包括支撑段以及贴靠段，其支撑段能让瓣膜假体整体向后瓣叶区域贴靠，使其最大限度地减少其瓣膜假体对左室流出道的遮挡。4. Different from the existing technology, in one embodiment of the present application, the sealing device includes a support section and an abutment section. The support section allows the entire valve prosthesis to abut against the rear leaflet area, minimizing the The valve prosthesis blocks the left ventricular outflow tract.
本申请的实施例可实现其它未一一列出的有益技术效果，这些其它的技术效果在下文中可能有部分描述，并且对于本领域的技术人员而言在阅读了本申请后是可以预期和理解的。Embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. of.
附图说明Description of drawings
通过参考下文的描述连同附图，这些实施例的上述特征和优点及其他特征和优点以及实现它们的方式将更显而易见，并且可以更好地理解本申请的实施例，在附图中：The above-described features and advantages and other features and advantages of these embodiments, as well as the manner of achieving them, will be more apparent, and embodiments of the present application may be better understood, by referring to the following description in conjunction with the accompanying drawings, in which:
图1a～1e为本发明瓣膜假体的整体结构示意图与外层支架、瓣膜支架的示意图。。1a to 1e are schematic diagrams of the overall structure of the valve prosthesis of the present invention and schematic diagrams of the outer stent and the valve stent. .
图2a～2d为本发明第一夹合组件、第二夹合组件释放的形态示意图与瓣膜假体在心内的示意图。Figures 2a to 2d are schematic diagrams of the release form of the first clamping component and the second clamping component of the present invention and a schematic diagram of the valve prosthesis in the heart.
图3a～3c为本发明第一夹合组件或第二夹合组件的原理图。Figures 3a to 3c are schematic diagrams of the first clamping component or the second clamping component of the present invention.
图4a和4b为本发明外层支架的另一实施方式。Figures 4a and 4b show another embodiment of the outer stent of the present invention.
图5a～5c为本发明收缩调整装置的示意图。Figures 5a to 5c are schematic diagrams of the contraction adjustment device of the present invention.
图6a～6d为本发明夹合组件与外层支架是分体的一个实施方式。6a to 6d show an embodiment of the present invention in which the clamping assembly and the outer support are separate bodies.
图7a～7d为本发明瓣膜支架上设有心房辅助杆件的一个实施方式。7a to 7d show an embodiment of the valve stent provided with an atrial auxiliary rod.
附图中各数字所指代的部位名称如下：1-外层支架，11-密封装置，111-支撑段，112-贴靠段，12-心室段，121-空白区域，2-瓣膜支架，3-人工瓣叶，4-第一夹合组件，5-第二夹合组件，6-收缩调节装置，7-心房辅助杆。The names of the parts designated by each number in the attached figure are as follows: 1-outer stent, 11-sealing device, 111-support section, 112-adherent section, 12-ventricular section, 121-blank area, 2-valve stent, 3-artificial valve leaflet, 4-first clamping component, 5-second clamping component, 6-contraction adjustment device, 7-atrial auxiliary rod.
具体实施方式Detailed ways
实施例一：Example 1:
如图1a～1e所示，在本实施例一中，在用于二尖瓣治疗时，一种可避免交界处反流的瓣膜假体，包括：外层支架1、设置在外层支架1内的瓣膜支架2以及固定在瓣膜支架2内的人工瓣叶3（在本实施例中人工瓣叶3可以是四叶瓣，当然也可以是二叶瓣或三叶瓣等情况），所述外层支架1包括密封装置11以及心室段12，所述密封装置11位于心房内，所述心室段12上设置有第一夹合组件4和第二夹合组件5，所述第一夹合组件4和第二夹合组件5被构造成用于捕捉并夹合相邻的自体瓣叶，如图2a和2b所示，其中，当所述外层支架1安装就位后，所述心室段12位于前瓣叶区域的一侧向后瓣叶区域的一侧凹陷，所述第一夹合组件4和第二夹合组件5分别靠近自体瓣叶交界处的两侧，并且，所述第一夹合组件4和第二夹合组件5分别夹合相邻的自体瓣叶（即前、后瓣叶），使得前、后瓣叶之间的距离被缩小。As shown in Figures 1a to 1e, in the first embodiment, when used for mitral valve treatment, a valve prosthesis that can avoid junction regurgitation includes: an outer stent 1; The valve stent 2 and the artificial valve leaflet 3 fixed in the valve stent 2 (in this embodiment, the artificial valve leaflet 3 can be a four-leaf valve, of course it can also be a bileaflet valve or a three-leaflet valve, etc.), the outer The layer stent 1 includes a sealing device 11 and a ventricular segment 12. The sealing device 11 is located in the atrium. The ventricular segment 12 is provided with a first clamping component 4 and a second clamping component 5. The first clamping component 4 and the second clamping assembly 5 are configured to capture and clamp adjacent autogenous valve leaflets, as shown in Figures 2a and 2b, wherein, when the outer stent 1 is installed in place, the ventricular segment 12 is located on one side of the anterior leaflet area and is recessed on one side of the posterior leaflet area. The first clamping component 4 and the second clamping component 5 are respectively close to both sides of the junction of the native valve leaflets, and the third A clamping component 4 and a second clamping component 5 respectively clamp adjacent autologous valve leaflets (ie, anterior and posterior valve leaflets), so that the distance between the anterior and posterior valve leaflets is reduced.
在本实施例中，所述第一夹合组件4和第二夹合组件5结构大体上类似，并且，所述第一夹合组件4包括2根用于夹持自体瓣叶的刚性杆件，当所述外层支架1植入时，2根刚性杆件分别捕捉前瓣叶和后瓣叶，在捕捉到前瓣叶和后瓣叶时，2根刚性杆件向着自体瓣叶对合边缘牵拉，使得自体瓣叶交界处区域的瓣叶聚拢，如图3a～3c所示，从而针对性填补自体瓣叶交界处的凹陷区域，有效避免血液反流。In this embodiment, the structures of the first clamping component 4 and the second clamping component 5 are substantially similar, and the first clamping component 4 includes two rigid rods for clamping autologous valve leaflets. , when the outer stent 1 is implanted, the two rigid rods capture the anterior leaflet and the posterior valve leaflet respectively. When the anterior valve leaflet and the posterior valve leaflet are captured, the two rigid rods align toward the native valve leaflet. The edge is pulled to bring together the leaflets in the junction area of the autologous valve leaflets, as shown in Figures 3a to 3c, thus filling the depressed area at the junction of the autologous valve leaflets in a targeted manner and effectively avoiding blood reflux.
在本实施例中，在自然形态下，所述外层支架1的心室段12设有第一凸起部和第二凸起部，并且，在所述外层支架1安装就位后，所述第一凸起部和第二凸起部分别位于自体瓣叶的交界处，并且，所述第一凸起部和第二凸起部用于填补自体瓣叶交界处凹陷区域的部分较为柔软，能自适应贴合生理组织；所述第一凸起部和第二凸起部既能填补交界处的凹陷区域，有效阻止血液反流，还能将瓣膜假体整体向后瓣叶区域抵靠，最大限度的让出流出道位置，避免对主动脉血流供应造成影响。In this embodiment, in the natural form, the ventricular segment 12 of the outer stent 1 is provided with a first protruding part and a second protruding part, and after the outer stent 1 is installed in place, the The first raised portion and the second raised portion are respectively located at the junction of the autologous valve leaflets, and the portions of the first raised portion and the second raised portion used to fill the recessed area at the junction of the autologous valve leaflets are relatively soft. , can adaptively fit physiological tissue; the first convex part and the second convex part can not only fill the recessed area at the junction, effectively prevent blood reflux, but also push the entire valve prosthesis against the posterior leaflet area. Reliance, to maximize the position of the outflow tract to avoid affecting the aortic blood flow supply.
在本实施例中，在所述外层支架1安装就位后，所述外层支架1的横截面呈半月形态，如图2c所示。In this embodiment, after the outer bracket 1 is installed in place, the cross section of the outer bracket 1 takes on a half-moon shape, as shown in Figure 2c.
在本实施例中，所述第一夹合组件4和第二夹合组件5均被构造为能够呈现第一形态和第二形态；其中，当所述第一夹合组件4和第二夹合组件5处于第一形态时，所述第一夹合组件4和第二夹合组件5分别捕捉相邻的自体瓣叶；其中，当所述第一夹合组件4和第二夹合组件5处于第二形态时，所述第一夹合组件4和第二夹合组件5分别带动相邻的自体瓣叶向自体瓣叶对合边缘牵拉。In this embodiment, the first clamping component 4 and the second clamping component 5 are both constructed to be able to present a first form and a second form; wherein, when the first clamping component 4 and the second clamping component 5 are in the first form, the first clamping component 4 and the second clamping component 5 respectively capture adjacent autologous leaflets; wherein, when the first clamping component 4 and the second clamping component 5 are in the second form, the first clamping component 4 and the second clamping component 5 respectively drive the adjacent autologous leaflets to be pulled toward the corresponding edges of the autologous leaflets.
在本实施例中，所述第一夹合组件4和第二夹合组件5呈“V”字形结构设置，如图3a所示，当所述第一夹合组件4和第二夹合组件5由第一形态转换为第二形态时，其“V”字形的2个端部逐渐聚拢，并带动相邻的自体瓣叶向自体瓣叶对合边缘牵拉，如图3b和3c所示。In this embodiment, the first clamping component 4 and the second clamping component 5 are arranged in a "V"-shaped structure, as shown in Figure 3a. When the first clamping component 4 and the second clamping component 5. When converting from the first form to the second form, the two ends of the "V" shape gradually come together, and drive the adjacent autologous valve leaflets to pull toward the joining edges of the autologous valve leaflets, as shown in Figures 3b and 3c .
在本实施例中，所述密封装置11包括支撑段111以及贴靠段112，在所述外层支架1安装就位后，所述支撑段111位于前瓣叶区域，并且所述支撑段111至少抵靠心房壁，如图2d所示，所述贴靠段112位于后瓣叶区域并贴合邻近的心房组织，支撑段111能让瓣膜假体整体向后瓣叶区域贴靠，使其最大限度地减少其瓣膜假体对左室流出道的遮挡。In this embodiment, the sealing device 11 includes a support section 111 and an abutment section 112. After the outer stent 1 is installed in place, the support section 111 is located in the front leaflet area, and the support section 111 At least against the atrial wall, as shown in Figure 2d, the abutment section 112 is located in the posterior leaflet area and adheres to the adjacent atrial tissue. The support section 111 allows the valve prosthesis as a whole to abut against the posterior leaflet area, making it Minimize the obstruction of the left ventricular outflow tract by its valve prosthesis.
本实施例一的一种带密封装置11的瓣膜假体的一个示范性的修复二尖瓣瓣膜的操作过程如下：An exemplary operation process for repairing the mitral valve of the valve prosthesis with the sealing device 11 of the first embodiment is as follows:
1. 操作输送系统从下腔静脉进入心脏，随后操作输送系统使其穿过房间隔；继续操作输送系统弯曲使其正对二尖瓣的瓣口；1. Operate the delivery system from the inferior vena cava into the heart, and then operate the delivery system to cross the interatrial septum; continue to operate the delivery system to bend it so that it faces the mitral valve orifice;
2. 操作输送系统使其远端位于自体瓣叶尖端以下的位置，再逐步释放外层支架1，此时，第一夹合组件4和第二夹合组件5处于第一形态，第一夹合组件4和第二夹合组件5分别捕捉相邻的自体瓣叶，继续操作输送系统，使得第一夹合组件4和第二夹合组件5由第一形态转换为第二形态，第一夹合组件4和第二夹合组件5分别牵拉前、后瓣叶并向着瓣叶对合缘区域靠拢，此时，外层支架1已安装就位，并且，外层支架1的横截面呈半月形态，如图2b所示；2. Operate the delivery system so that its distal end is located below the tip of the native leaflet, and then gradually release the outer stent 1. At this time, the first clamping component 4 and the second clamping component 5 are in the first state, and the first clamping component 4 and the second clamping component 5 respectively capture the adjacent native leaflets. Continue to operate the delivery system so that the first clamping component 4 and the second clamping component 5 are converted from the first state to the second state. The first clamping component 4 and the second clamping component 5 respectively pull the anterior and posterior leaflets and move them closer to the leaflet abutment edge area. At this time, the outer stent 1 has been installed in place, and the cross section of the outer stent 1 is in a half-moon shape, as shown in FIG. 2b ;
3.随后将瓣膜支架2释放至外层支架1的中部区域，如图2c所示并且瓣膜支架2的中心与自体瓣膜的中心不重合，并且，瓣膜支架2的中心靠近后瓣叶区域，如图2d所示。3. Then release the valve stent 2 to the middle area of the outer stent 1, as shown in Figure 2c and the center of the valve stent 2 does not coincide with the center of the native valve, and the center of the valve stent 2 is close to the posterior leaflet area, such as As shown in Figure 2d.
实施例二：Example 2:
实施例二与实施例一大体上相同。不同之处在于，本实施例二中，外层支架1的心室段12上设有空白区域121，不影响前瓣叶的摆动，避免对左室流出道产生阻挡。Embodiment 2 is substantially the same as Example 2. The difference is that in the second embodiment, a blank area 121 is provided on the ventricular segment 12 of the outer stent 1, which does not affect the swing of the front leaflets and avoids obstruction to the left ventricular outflow tract.
在本实施例中，所述心室段12为网格支架，如图4a和4b所示，并且，所述心室段12上设有空白区域121，并且，该空白区域121在心室段12上的形态大体呈“U”形结构，在所述外层支架1安装就位后，所述空白区域121位于前瓣叶区域；当自体瓣膜开闭时，其前瓣叶依旧能摆动，并且在自体瓣膜关闭时，前瓣叶位于所述的空白区域121，这样能有效减少。In this embodiment, the ventricular segment 12 is a mesh stent, as shown in Figures 4a and 4b, and a blank area 121 is provided on the ventricular segment 12, and the blank area 121 is located on the ventricular segment 12. The shape is generally a "U"-shaped structure. After the outer stent 1 is installed in place, the blank area 121 is located in the front leaflet area; when the autologous valve opens and closes, the front leaflet can still swing, and in the autologous valve, the front leaflet can still swing. When the valve is closed, the front valve leaflet is located in the blank area 121, which can effectively reduce the amount of valve leaflet leakage.
实施例二的其余构造和构思类似于实施例一，因此在这里不再重复描述。The remaining structures and concepts of the second embodiment are similar to those of the first embodiment, and thus will not be described again here.
实施例三：Embodiment three:
实施例三与实施例一大体上相同。不同之处在于，本实施例三中，第一夹合组件4和第二夹合组件5分别由2根夹持杆件组成，并且由收缩调节装置6来控制2根夹持杆件之间的距离，使其能对交界处瓣叶的收缩程度得到精准控制。Embodiment 3 is substantially the same as Example 3. The difference is that in the third embodiment, the first clamping component 4 and the second clamping component 5 are each composed of two clamping rods, and the contraction adjustment device 6 controls the distance between the two clamping rods. distance, allowing it to accurately control the degree of contraction of the leaflets at the junction.
在本实施例中，所述收缩调节装置6为线控装置，如图5a～5c所示，所述线控装置分别与第一夹合组件4和第二夹合组件5可拆卸连接，利用拉线来控制第一夹合组件4（或是第二夹合组件5）的夹持杆件之间的距离。In this embodiment, the shrinkage adjustment device 6 is a wire-controlled device. As shown in Figures 5a to 5c, the wire-controlled device is detachably connected to the first clamping component 4 and the second clamping component 5 respectively. The distance between the clamping rods of the first clamping component 4 (or the second clamping component 5) is controlled by pulling the wire.
实施例三的其余构造和构思类似于实施例一，因此在这里不再重复描述。The rest of the structure and concept of Embodiment 3 are similar to Embodiment 1, and therefore will not be described again here.
实施例四：Embodiment 4:
实施例四与实施例一大体上相同。不同之处在于，本实施例四中，夹合组件（即第一夹合组件4和第二夹合组件5）与外层支架1是分体的，其夹合组件（即第一夹合组件4和第二夹合组件5）由单独的一套输送系统入路。Embodiment 4 is substantially the same as Example 4. The difference is that in the fourth embodiment, the clamping component (i.e., the first clamping component 4 and the second clamping component 5) is separate from the outer bracket 1, and its clamping component (i.e., the first clamping component 5) is separate from the outer bracket 1. Component 4 and the second clamping component 5) are accessed by a separate delivery system.
在本实施例中，包括第一输送系统（即装载有第一夹合组件4和第二夹合组件5的输送系统）和第二输送系统（即装载有外层支架1和瓣膜支架2的输送系统），先将第一输送系统由经心尖入路，并操作第一输送系统使得第一夹合组件4和第二夹合组件5分别捕捉并夹合前、后瓣叶的交界处（或是靠近前、后瓣叶的交界处的自体瓣叶），如图6a和6b所示，完成夹合后，将第二输送系统由下腔静脉进入心脏，随后操作第二输送系统使其穿过房间隔；继续操作第二输送系统弯曲使其正对二尖瓣的瓣口，进一步操作第二输送系统使其外层支架1以及瓣膜支架2被释放，由于瓣叶交界处被第一夹合组件4和第二夹合组件5夹闭，如图6c和6d所示，因为交界处的反流极少，其防反流效果理想。In this embodiment, it includes a first delivery system (ie, a delivery system loaded with the first clamping component 4 and a second clamping component 5) and a second delivery system (ie, a delivery system loaded with the outer stent 1 and the valve stent 2). Delivery system), first use the transapical approach to the first delivery system, and operate the first delivery system so that the first clamping component 4 and the second clamping component 5 respectively capture and clamp the junction of the anterior and posterior valve leaflets ( Or the autogenous valve leaflet near the junction of the anterior and posterior valve leaflets), as shown in Figures 6a and 6b. After completing the clamping, the second delivery system is entered into the heart through the inferior vena cava, and then the second delivery system is operated to Pass through the interatrial septum; continue to operate the second delivery system to bend it to face the mitral valve orifice, and further operate the second delivery system to release the outer stent 1 and the valve stent 2. Since the junction of the valve leaflets is first The clamping component 4 and the second clamping component 5 are clamped together, as shown in Figures 6c and 6d. Since there is very little reflux at the junction, the reflux prevention effect is ideal.
实施例四的其余构造和构思类似于实施例一，因此在这里不再重复描述。The rest of the structure and concept of Embodiment 4 are similar to Embodiment 1, and therefore will not be described again here.
实施例五：Embodiment five:
实施例五与实施例一大体上相同。不同之处在于，本实施例五中，外层支架1只有心室段12，并且，瓣膜支架2上设有心房辅助杆件7。The fifth embodiment is substantially the same as the first embodiment, except that, in the fifth embodiment, the outer layer stent 1 has only the ventricular segment 12 , and the valve stent 2 is provided with an atrial auxiliary rod 7 .
在本实施例中，一种可避免交界处反流的瓣膜假体，如图7a～7d所示，包括外层支架1、设置在外层支架1内的瓣膜支架2以及固定在瓣膜支架2内的人工瓣叶3，所述瓣膜支架2设有多根心房辅助杆7，所述外层支架1仅包括心室段12，所述心室段12上设置有第一夹合组件4和第二夹合组件5，所述第一夹合组件4和第二夹合组件5被构造成用于捕捉并夹合相邻的自体瓣叶，其中，当所述外层支架1安装就位后，所述心室段12位于前瓣叶区域的一侧向后瓣叶区域的一侧凹陷，所述第一夹合组件4和第二夹合组件5分别位于或靠近自体瓣叶交界处的两侧，并且，所述第一夹合组件4和第二夹合组件5分别夹合相邻的自体瓣叶，使得相邻自体瓣叶之间的距离被缩小，外层支架1安装后，瓣膜支架2进入外层支架1内径向扩张，第一夹合组件4与第二夹合组件5位于瓣膜支架2的左右两侧，并且，心房辅助杆7在心房内并提供支撑力。In this embodiment, a valve prosthesis that can avoid junction regurgitation, as shown in Figures 7a to 7d, includes an outer stent 1, a valve stent 2 arranged in the outer stent 1, and a valve stent 2 fixed in the valve stent 2 The artificial valve leaflet 3, the valve stent 2 is provided with a plurality of atrial auxiliary rods 7, the outer stent 1 only includes a ventricular segment 12, the ventricular segment 12 is provided with a first clamping component 4 and a second clamp The first clamping component 4 and the second clamping component 5 are configured to capture and clamp adjacent autologous valve leaflets, wherein, when the outer stent 1 is installed in place, the The side of the ventricular segment 12 located in the anterior valve leaflet area is recessed on the side of the posterior valve leaflet area, and the first clamping component 4 and the second clamping component 5 are respectively located at or near both sides of the junction of the native valve leaflets, Moreover, the first clamping component 4 and the second clamping component 5 respectively clamp adjacent autologous valve leaflets, so that the distance between adjacent autologous valve leaflets is reduced. After the outer stent 1 is installed, the valve stent 2 When the outer stent 1 is radially expanded, the first clamping component 4 and the second clamping component 5 are located on the left and right sides of the valve stent 2 , and the atrial auxiliary rod 7 is in the atrium and provides support.
实施例五的其余构造和构思类似于实施例一，因此在这里不再重复描述。The remaining structures and concepts of Embodiment 5 are similar to Embodiment 1, and therefore will not be described again here.
出于说明的目的而提出了对本申请的示例实施例的前文描述。前文描述并非意图是穷举的，也并非将本申请限于所公开的精确配置和/或构造，显然，根据上文的教导，本领域的技术人员可作出许多修改和变型而不偏离本发明。本发明的范围和等同物旨在由所附权利要求限定。The foregoing description of the example embodiments of the present application has been presented for the purpose of illustration. The foregoing description is not intended to be exhaustive or to limit the application to the precise arrangements and/or constructions disclosed, and obviously many modifications and variations can be made by those skilled in the art in light of the above teachings without departing from the invention. The scope and equivalents of the invention are intended to be defined by the appended claims.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211152778.5ACN117771021A (en) | 2022-09-21 | 2022-09-21 | Valve prosthesis capable of avoiding reverse flow at junction |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211152778.5ACN117771021A (en) | 2022-09-21 | 2022-09-21 | Valve prosthesis capable of avoiding reverse flow at junction |
| Publication Number | Publication Date |
|---|---|
| CN117771021Atrue CN117771021A (en) | 2024-03-29 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211152778.5APendingCN117771021A (en) | 2022-09-21 | 2022-09-21 | Valve prosthesis capable of avoiding reverse flow at junction |
| Country | Link |
|---|---|
| CN (1) | CN117771021A (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
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| US20150202044A1 (en)* | 2009-12-04 | 2015-07-23 | Mark Chau | Prosthetic valve for replacing mitral valve |
| US20170258589A1 (en)* | 2016-03-08 | 2017-09-14 | Dura Biotech | Heart valve leaflet replacement system and method for same |
| CN109199640A (en)* | 2018-10-24 | 2019-01-15 | 宁波健世生物科技有限公司 | A kind of artificial valve prosthese |
| CN109199641A (en)* | 2018-10-24 | 2019-01-15 | 宁波健世生物科技有限公司 | A kind of artificial valve prosthese with fixing piece |
| CN109394393A (en)* | 2017-08-18 | 2019-03-01 | 上海微创心通医疗科技有限公司 | Heart valve prosthesis |
| CN216257643U (en)* | 2021-09-30 | 2022-04-12 | 宁波健世科技股份有限公司 | Heart valve prosthesis capable of being anchored with autologous valve leaflet |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20150202044A1 (en)* | 2009-12-04 | 2015-07-23 | Mark Chau | Prosthetic valve for replacing mitral valve |
| US20170258589A1 (en)* | 2016-03-08 | 2017-09-14 | Dura Biotech | Heart valve leaflet replacement system and method for same |
| CN109394393A (en)* | 2017-08-18 | 2019-03-01 | 上海微创心通医疗科技有限公司 | Heart valve prosthesis |
| CN109199640A (en)* | 2018-10-24 | 2019-01-15 | 宁波健世生物科技有限公司 | A kind of artificial valve prosthese |
| CN109199641A (en)* | 2018-10-24 | 2019-01-15 | 宁波健世生物科技有限公司 | A kind of artificial valve prosthese with fixing piece |
| CN216257643U (en)* | 2021-09-30 | 2022-04-12 | 宁波健世科技股份有限公司 | Heart valve prosthesis capable of being anchored with autologous valve leaflet |
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