技术领域Technical field
本发明属于医疗器械技术领域，具体涉及一种可调节二尖瓣膜修复器械系统。The invention belongs to the technical field of medical devices, and specifically relates to an adjustable mitral valve repair device system.
背景技术Background technique
二尖瓣反流(MR)是最常见的瓣膜病变，欧美流行病学研究数据显示，75岁以上人群中，MR罹患率达10％，明显超过主动脉瓣膜病变。同样，随着我国人口老龄化病变进程的加重，二尖瓣反流病变也将导致沉重的医疗负担。二尖瓣修复术或置换术是MR治疗方法的金标准，但一些研究表明多达一半的症状严重的MR患者未选择手术治疗，其原因很大一定程度上与其手术风险相关。这一大部分对外科手术耐受性较差的患者迫切需要一种创伤较小的治疗方法作为替代方案，介入二尖瓣治疗技术应势而生。Mitral regurgitation (MR) is the most common valvular disease. European and American epidemiological study data show that among people over 75 years old, the prevalence rate of MR reaches 10%, significantly exceeding aortic valve disease. Similarly, as my country's population ages and the disease process worsens, mitral regurgitation disease will also lead to a heavy medical burden. Mitral valve repair or replacement is the gold standard treatment for MR, but some studies have shown that up to half of MR patients with severe symptoms do not choose surgical treatment, and the reasons are largely related to the risks of surgery. This majority of patients who have poor tolerance for surgery urgently need a less invasive treatment method as an alternative, and interventional mitral valve treatment technology has emerged in response to the situation.
目前临床中仅有雅培的缘对缘瓣叶修复(MitralClip)获得了NMPA的批准，然而缘对缘修复对于原发性二尖瓣关闭不全(DMR)有良好的治疗效果，但对于继发性二尖瓣关闭不全(FMR)的效果比较有限；而且缘对缘修复往往也会造成瓣叶的损伤。Currently, only Abbott's edge-to-edge leaflet repair (MitralClip) has been approved by the NMPA in clinical practice. However, edge-to-edge repair has good therapeutic effects for primary mitral regurgitation (DMR), but it is not effective for secondary mitral regurgitation. The effectiveness of mitral regurgitation (FMR) is limited; edge-to-edge repair often causes leaflet damage.
发明内容Contents of the invention
本发明要解决的技术问题是提供一种可减轻对瓣叶的损伤，并且改善对继发性二尖瓣关闭不全患者的作用效果的可调节二尖瓣膜修复器械系统。本发明通过间接环缩的方式减少二尖瓣返流，相对于缘对缘修复而言不与二尖瓣直接接触，不损伤二尖瓣结构。The technical problem to be solved by the present invention is to provide an adjustable mitral valve repair device system that can reduce damage to the valve leaflets and improve the effect on patients with secondary mitral regurgitation. The present invention reduces mitral valve regurgitation through indirect annular contraction. Compared with edge-to-edge repair, it does not directly contact the mitral valve and does not damage the mitral valve structure.
为实现上述技术目的，达到上述技术效果，本发明通过以下技术方案实现：In order to achieve the above technical objectives and achieve the above technical effects, the present invention is implemented through the following technical solutions:
一种可调节二尖瓣膜修复器械系统，包括第一导管、第二导管、置于第一导管或第二导管内的导丝、置于第一导管或第二导管头端部的导丝定位或捕捉工具、以及用于固定导丝的固定植入物。An adjustable mitral valve repair device system, including a first catheter, a second catheter, a guide wire placed in the first catheter or the second catheter, and a guide wire positioning placed at the head end of the first catheter or the second catheter or capture tools, and fixation implants used to secure guidewires.
进一步的，所述可调节二尖瓣膜修复器械系统还包括双腔导管，所述第一导管和第二导管置于所述双腔导管内。Further, the adjustable mitral valve repair device system further includes a dual-lumen catheter, and the first catheter and the second catheter are placed in the dual-lumen catheter.
优选的，所述导丝定位或捕捉工具为磁铁。Preferably, the guidewire positioning or capturing tool is a magnet.
优选的，所述导丝定位或捕捉工具为捕捉网篮或者机械手。Preferably, the guidewire positioning or capturing tool is a capturing basket or a manipulator.
进一步的，所述修复器械系统还包括置于第一导管或第二导管头端部背面的支持设施。Further, the repair instrument system further includes a support facility placed on the back of the head end of the first catheter or the second catheter.
优选的，所述支持设施为球囊。Preferably, the support facility is a balloon.
本发明具有以下优点：The invention has the following advantages:
1、本发明通过间接环缩的方式减少二尖瓣返流，相对于缘对缘修复而言不与二尖瓣直接接触，不损伤二尖瓣结构。1. The present invention reduces mitral valve regurgitation through indirect annular contraction. Compared with edge-to-edge repair, it does not directly contact the mitral valve and does not damage the mitral valve structure.
2、本发明通路的建立包含双通道和单通道两种路径方式，为临床上的使用提供了更多选择。2. The establishment of the pathway of the present invention includes two path modes: dual channel and single channel, which provides more choices for clinical use.
3、本发明通过磁铁/捕捉网篮或机械手的方式实现导管精准定位/导丝捕捉，以及通过增加球囊等措施进行支持从而避免心肌的回弹，提高了该修复器械系统的可操作性。3. The present invention achieves precise positioning of the catheter/capture of the guide wire through magnets/capture baskets or manipulators, and supports by adding balloons and other measures to avoid myocardial rebound, thereby improving the operability of the repair device system.
附图说明Description of the drawings
图1为通路建立使用双通道的示意图。Figure 1 is a schematic diagram of using dual channels for channel establishment.
图2为通路建立使用单通道的示意图。Figure 2 is a schematic diagram of channel establishment using a single channel.
图3为第一导管和第二导管使用磁铁吸附定位的示意图。Figure 3 is a schematic diagram of the first conduit and the second conduit being adsorbed and positioned using magnets.
图4为使用捕捉网篮捕捉导丝的示意图。Figure 4 is a schematic diagram of using a capture basket to capture the guide wire.
图5为使用磁铁吸附定位的同时增加球囊的示意图。Figure 5 is a schematic diagram of using magnets to adsorb and position while adding a balloon.
图6为使用捕捉网篮捕捉导丝的同时增加球囊的示意图。Figure 6 is a schematic diagram of using a capture basket to capture the guidewire while adding a balloon.
图7为植入固定植入物完成固定的示意图。Figure 7 is a schematic diagram of the implantation of the fixation implant to complete the fixation.
图中：1-颈静脉；2-右心房；3-股静脉；4-左心房；5-心大静脉；6-房间隔；7-第一导管；8-第二导管；9-双腔导管；10-导丝；11-磁铁；12-捕捉网篮；13-球囊；14-固定植入物。In the figure: 1-jugular vein; 2-right atrium; 3-femoral vein; 4-left atrium; 5-great cardiac vein; 6-atrial septum; 7-first duct; 8-second duct; 9-double chamber Catheter; 10-guide wire; 11-magnet; 12-capture basket; 13-balloon; 14-fixed implant.
具体实施方式Detailed ways
为使本发明更明显易懂，兹以优选实施例，并配合附图作详细说明如下。In order to make the present invention more obvious and understandable, preferred embodiments are described in detail below along with the accompanying drawings.
参照图1-图7，一种可调节二尖瓣膜修复器械系统，主要包括第一导管7、第二导管8、双腔导管9、置于第一导管7或第二导管8内的导丝10、磁铁11、捕捉网篮12或者机械手、球囊13、以及用于固定导丝的固定植入物14。Referring to Figures 1-7, an adjustable mitral valve repair device system mainly includes a first catheter 7, a second catheter 8, a dual-lumen catheter 9, and a guidewire placed in the first catheter 7 or the second catheter 8. 10. Magnet 11, capture basket 12 or manipulator, balloon 13, and fixation implant 14 for fixing the guide wire.
以下结合具体实施方式说明本发明可调节二尖瓣膜修复器械系统的各部件之间的结构和使用方法。The structure and use method of each component of the adjustable mitral valve repair device system of the present invention will be described below in conjunction with specific embodiments.
本发明的可调节二尖瓣膜修复器械系统，是通过间接环缩的方式减少二尖瓣返流，该系统的使用方法主要包括如下步骤：首先需要建立通路(步骤1)，然后使用穿刺装置完成心房壁穿刺，使用牵拉植入物连接心大静脉与房间隔以实现通路的连接(步骤2)，最后植入固定植入物完成固定以缩短二尖瓣环前后径即AP直径(步骤3)。The adjustable mitral valve repair device system of the present invention reduces mitral valve regurgitation through indirect annular contraction. The method of using the system mainly includes the following steps: first, a passage needs to be established (step 1), and then a puncture device is used to complete The atrial wall is punctured, and a traction implant is used to connect the great cardiac vein and interatrial septum to connect the access (step 2). Finally, a fixed implant is implanted to complete the fixation to shorten the anteroposterior diameter of the mitral annulus, that is, the AP diameter (step 3 ).
参照图1，在一种实施方式中，所述步骤1的通路为双通道，包含两条路径，分别为通路一和通路二，其中，所述通路一从颈静脉1穿刺进入右心房2后，经冠状窦口进入心大静脉5；所述通路二从股静脉3穿刺进入右心房2，穿刺房间隔6后进入左心房4内；完成通路的建立后，使用穿刺装置对心房壁进行穿刺后，使用牵拉植入物连接心大静脉5与房间隔6，以实现通路一和通路二的连接；最后分别在心大静脉5与房间隔6处植入固定植入物14完成固定，以缩短二尖瓣环前后径。Referring to Figure 1, in one embodiment, the passage in step 1 is a double channel, including two paths, namely passage one and passage two, wherein the passage one is punctured from the jugular vein 1 into the right atrium 2 , enters the great cardiac vein 5 through the coronary sinus ostium; the passage two punctures from the femoral vein 3 into the right atrium 2, punctures the interatrial septum 6 and then enters the left atrium 4; after completing the establishment of the passage, use the puncture device to puncture the atrial wall Finally, a traction implant is used to connect the great cardiac vein 5 and the interatrial septum 6 to realize the connection of channel one and channel two; finally, fixation implants 14 are implanted in the great cardiac vein 5 and the interatrial septum 6 respectively to complete the fixation. Shorten the anteroposterior diameter of the mitral annulus.
进一步的，所述通路一和通路二的连接分别使用第一导管7和第二导管8，所述第一导管7或第二导管8内置有用于连接心大静脉5与房间隔6的牵拉植入物，所述牵拉植入物优选为导丝10。Furthermore, the first conduit 7 and the second conduit 8 are respectively connected to the first and second passages. The first conduit 7 or the second conduit 8 has built-in traction for connecting the great cardiac vein 5 and the interatrial septum 6 Implant, the pulling implant is preferably a guide wire 10.
在另一种实施方式中，参照图2，所述步骤1的通路为单通道，通路的建立使用双腔导管9，通路通过股静脉3进入右心房2后，双腔导管9分为两条导管，分别为第一导管7和第二导管8；其中，所述第一导管7经冠状窦口进入心大静脉5，所述第二导管8进行房间隔6穿刺后进入左心房4；完成通路的建立后，使用穿刺装置对心房壁进行穿刺后，使用牵拉植入物连接心大静脉5与房间隔6；最后分别在心大静脉5与房间隔6处植入固定植入物14完成固定，以缩短二尖瓣环前后径。In another embodiment, referring to Figure 2, the passage in step 1 is a single channel, and a double-lumen catheter 9 is used to establish the passage. After the passage enters the right atrium 2 through the femoral vein 3, the double-lumen catheter 9 is divided into two The catheters are respectively the first catheter 7 and the second catheter 8; wherein, the first catheter 7 enters the great cardiac vein 5 through the coronary sinus ostium, and the second catheter 8 punctures the interatrial septum 6 and enters the left atrium 4; completed After the access is established, a puncture device is used to puncture the atrial wall, and a traction implant is used to connect the great cardiac vein 5 and the interatrial septum 6; finally, fixed implants 14 are implanted in the great cardiac vein 5 and the interatrial septum 6 respectively to complete the process. Fixed to shorten the anteroposterior diameter of the mitral annulus.
在上述实施方案中，完成静脉穿刺和房间隔6穿刺后，通路中的第一导管7和第二导管8分别置于心大静脉5与左心房4内。为了更好地实现通路的连接，在一种实施方式中，参照图3，所述第一导管7和第二导管8头端部设置有磁铁11，在心大静脉5处对心房壁进行穿刺后，两条导管头端通过磁铁11吸附，以实现二者在心大静脉5处的精准定位；然后将导丝10穿过左心房4，完成两条通路的连接。In the above embodiment, after completing the venipuncture and puncture of the interatrial septum 6 , the first catheter 7 and the second catheter 8 in the passage are respectively placed in the great cardiac vein 5 and the left atrium 4 . In order to better realize the connection of the passages, in one embodiment, referring to Figure 3, magnets 11 are provided at the head ends of the first catheter 7 and the second catheter 8. After puncturing the atrial wall at the great cardiac vein 5 , the two catheter heads are adsorbed by magnets 11 to achieve precise positioning of the two at the great cardiac vein 5; then the guide wire 10 is passed through the left atrium 4 to complete the connection of the two pathways.
在另一种实施方式中，参照图4，所述通路二左心房4内的第二导管8头端部设置有捕捉网篮12或者机械手，在心大静脉5处对心房壁进行穿刺后，左心房4内使用所述捕捉网篮12或者机械手进行导丝10捕捉，然后将导丝10穿过左心房4，完成两条通路的连接。In another embodiment, referring to Figure 4, the head end of the second catheter 8 in the left atrium 4 of the second passage is provided with a catching basket 12 or a manipulator. After puncturing the atrial wall at the great cardiac vein 5, the left atrium The guide wire 10 is captured in the atrium 4 using the capture basket 12 or a robot hand, and then the guide wire 10 is passed through the left atrium 4 to complete the connection of the two pathways.
为了避免穿刺过程中心肌的回弹，参照图5和图6，心大静脉5处第一导管7头端部背面可以通过增加球囊13，或其他常用措施进行支持。In order to avoid myocardial rebound during puncture, referring to Figures 5 and 6, the back of the head end of the first catheter 7 at the great cardiac vein 5 can be supported by adding a balloon 13, or other common measures.
以上实施方式中均由心大静脉5向左心房4内进行连接，即由第一导管7向第二导管8连接，但通路更换由左心房4向心大静脉5处连接，即由第二导管8向第一导管7连接依旧可行。In the above embodiments, the great cardiac vein 5 is connected to the left atrium 4, that is, the first conduit 7 is connected to the second conduit 8. However, the passage is changed to be connected from the left atrium 4 to the great cardiac vein 5, that is, the second conduit 7 is connected to the great cardiac vein 5. The connection of the conduit 8 to the first conduit 7 is still possible.
在完成两个通路的连接后，参照图7，在心大静脉5和房间隔6处分别植入固定植入物14完成固定，通过导丝10的牵拉作用缩短二尖瓣环前后径。After completing the connection of the two channels, referring to Figure 7 , fixation implants 14 are respectively implanted in the great cardiac vein 5 and the interatrial septum 6 to complete the fixation, and the anteroposterior diameter of the mitral annulus is shortened through the pulling effect of the guide wire 10 .
应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施例中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。It should be understood that although this specification is described in terms of implementations, not each implementation only contains an independent technical solution. This description of the specification is only for the sake of clarity. Persons skilled in the art should take the specification as a whole and understand each individual solution. The technical solutions in the embodiments can also be appropriately combined to form other implementations that can be understood by those skilled in the art.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311069419.8ACN117179969A (en) | 2023-08-23 | 2023-08-23 | Adjustable mitral valve repair instrument system |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311069419.8ACN117179969A (en) | 2023-08-23 | 2023-08-23 | Adjustable mitral valve repair instrument system |
| Publication Number | Publication Date |
|---|---|
| CN117179969Atrue CN117179969A (en) | 2023-12-08 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311069419.8APendingCN117179969A (en) | 2023-08-23 | 2023-08-23 | Adjustable mitral valve repair instrument system |
| Country | Link |
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| CN (1) | CN117179969A (en) |
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