技术领域Technical field
本申请涉及一种多种锚定方式的二尖瓣修复装置，属于医疗器械技术领域。The present application relates to a mitral valve repair device with multiple anchoring methods, and belongs to the technical field of medical devices.
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.
在过去的十年中，几种由不同外科术式衍生而来的经导管二尖瓣修复技术已经出现，并用于治疗手术高危或无法手术的患者。经导管二尖瓣修复“工具箱”正在迅速扩展，欧洲已批准多达5种设备批准应用于临床(CE mark)，包括MitraClip(Abbott Vascular–缘对缘瓣叶修复),the DS1000装置(NeoChord,Inc，介入人工腱索修复),the Carillon(Cardiac Dimensions,经冠状静脉窦瓣环成型装置),the CardioBand(Edward ValtechCardio，介入二尖瓣成型环),the Mitralign装置(Mitralign,二尖瓣瓣环折叠技术)。在目前的临床实践中，经导管二尖瓣修复使用的装置主要是模仿Alfieri提出的对缘瓣叶修复的MitraClip装置，自2003年MitraClip推出以来，已有超过80,000名患者接受了治疗，并获得FDA批准，由我国学者及医疗科技公司共同研发的两款二尖瓣修复器械MitralStitch(德晋医疗-介入人工腱索修复)及ValveClamp(捍宇医疗-介入缘对缘瓣叶修复)也取得了进展。Over the past decade, several transcatheter mitral valve repair techniques derived from different surgical procedures have emerged and are used to treat high-risk or inoperable patients. The transcatheter mitral valve repair “toolbox” is rapidly expanding, with up to 5 devices approved for clinical use (CE mark) in Europe, including the MitraClip (Abbott Vascular – edge-to-edge leaflet repair), the DS1000 device (NeoChord , Inc, interventional artificial chordae tendineae repair), the Carillon (Cardiac Dimensions, transcoronary sinus annuloplasty device), the CardioBand (Edward ValtechCardio, interventional mitral annuloplasty ring), the Mitralign device (Mitralign, mitral valve annuloplasty device) ring folding technology). In current clinical practice, the device used for transcatheter mitral valve repair mainly imitates the MitraClip device for limbal valve leaflet repair proposed by Alfieri. Since the launch of MitraClip in 2003, more than 80,000 patients have received treatment and achieved success. FDA approved two mitral valve repair devices, MitralStitch (Dejin Medical - interventional artificial chordae repair) and ValveClamp (Hanyu Medical - interventional edge-to-edge valve leaflet repair) jointly developed by Chinese scholars and medical technology companies. progress.
其中一项国际领先的技术，以其独特的设计，最大限度地利用人体自然腔道，对一大部分二尖瓣返流有良好的效果。该技术通过介入手术装置，植入冠状窦心大静脉内锚定装置2(见图1)、房间隔锚定装置3(见图1)以及与二者相连接的牵伸线1(见图1)，依靠物理的张力，将左心房和二尖瓣进行物理空间重塑，从而减小或消除因二尖瓣闭合不全带来的血液返流。One of the world's leading technologies, with its unique design, maximizes the use of the natural orifice of the human body and has good effects on a large proportion of mitral regurgitation. This technology uses an interventional surgical device to implant the intracoronary sinus and great cardiac vein anchoring device 2 (see Figure 1), the interatrial septal anchoring device 3 (see Figure 1), and the stretching wire 1 connected to the two (see Figure 1). 1), relying on physical tension to reshape the physical space of the left atrium and mitral valve, thereby reducing or eliminating blood regurgitation caused by mitral valve insufficiency.
目前技术的其中一个锚定装置一(图1中的冠状窦心大静脉内锚定装置2、图2中的锚定装置一11)，需要从颈静脉穿刺，进入右心房后，经冠状窦口进入心大静脉，另一个锚定装置二(图1中的房间隔锚定装置3、图2中的锚定装置二14)通过股静脉进入右心房，穿刺房间隔并锚定与房间隔上。锚定装置一上固定桥接线，桥接线从锚定装置二内穿过，用于收紧左心房，如图2，使得收紧左心房后，心脏的前后径减小并改善二尖瓣反流以及心房扩大以及心衰等。One of the anchoring devices in the current technology (the coronary sinus intracardiac anchoring device 2 in Figure 1 and the anchoring device 11 in Figure 2) requires puncture from the jugular vein, enters the right atrium, and passes through the coronary sinus. The other anchoring device 2 (atrial septal anchoring device 3 in Figure 1, anchoring device 2 14 in Figure 2) enters the right atrium through the femoral vein, punctures the interatrial septum and anchors to the interatrial septum. superior. The bridge wire is fixed on the first anchoring device, and the bridge wire passes through the second anchoring device and is used to tighten the left atrium, as shown in Figure 2. After tightening the left atrium, the anteroposterior diameter of the heart is reduced and mitral valve regurgitation is improved. flow, atrial enlargement, heart failure, etc.
发明内容Contents of the invention
本申请要解决的技术问题是由于每个病人心脏解剖结构存在差异，目前技术的锚定装置一、锚定装置二、桥接线在使用时，方位角度以及所在平面难以根据需要调整到最佳角度。The technical problem to be solved by this application is that due to the differences in the cardiac anatomy of each patient, when the current anchoring device 1, anchoring device 2, and bridging wire are used, the azimuth angle and the plane are difficult to adjust to the optimal angle as needed. .
因此，锚定装置需要根据解剖结构，优化为适合的设计。Therefore, the anchoring device needs to be optimized to a suitable design based on the anatomical structure.
为此，本申请的技术方案是提供了多种锚定方式的二尖瓣修复装置，包括：To this end, the technical solution of this application is to provide a mitral valve repair device with multiple anchoring methods, including:
锚定装置一，锚定装置二；所述锚定装置一与锚定装置二通过桥接线连接；Anchoring device one, anchoring device two; the anchoring device one and the anchoring device two are connected through a bridge wire;
所述锚定装置一、锚定装置二置于以下不同组合位置：The first and second anchoring devices are placed in the following different combination positions:
所述锚定装置一置于心大静脉内、所述锚定装置二置于房间隔，The first anchoring device is placed in the great cardiac vein, and the second anchoring device is placed in the interatrial septum,
或，所述锚定装置一置于左心房壁内、所述锚定装置二置于房间隔，Or, the first anchoring device is placed in the left atrium wall, and the second anchoring device is placed in the interatrial septum,
或，所述锚定装置一置于左心房壁外、所述锚定装置二置于房间隔，Or, the first anchoring device is placed outside the left atrium wall, and the second anchoring device is placed in the interatrial septum,
或，所述锚定装置一置于冠状动脉系统的左主干、所述锚定装置二置于房间隔，Or, the first anchoring device is placed on the left main trunk of the coronary artery system, and the second anchoring device is placed on the interatrial septum,
或，所述锚定装置一置于冠状动脉系统的左回旋支、所述锚定装置二置于房间隔，Or, the first anchoring device is placed on the left circumflex artery of the coronary artery system, and the second anchoring device is placed on the interatrial septum,
或，所述锚定装置一置于心大静脉内、所述锚定装置二置于主动脉，Or, the first anchoring device is placed in the great cardiac vein, and the second anchoring device is placed in the aorta,
或，所述锚定装置一置于左心房壁内、所述锚定装置二置于主动脉，Or, the first anchoring device is placed in the left atrium wall, and the second anchoring device is placed in the aorta,
或，所述锚定装置一置于左心房壁外、所述锚定装置二置于主动脉，Or, the first anchoring device is placed outside the left atrium wall, and the second anchoring device is placed in the aorta,
或，所述锚定装置一置于冠状动脉系统的左主干、所述锚定装置二置于主动脉，Or, the first anchoring device is placed on the left main trunk of the coronary system, and the second anchoring device is placed on the aorta,
或，所述锚定装置一置于冠状动脉系统的左回旋支、所述锚定装置二置于主动脉，Or, the first anchoring device is placed on the left circumflex branch of the coronary artery system, and the second anchoring device is placed on the aorta,
或，所述锚定装置一置于心大静脉内、所述锚定装置二置于右室流出道，Or, the first anchoring device is placed in the great cardiac vein, and the second anchoring device is placed in the right ventricular outflow tract,
或，所述锚定装置一置于左心房壁内、所述锚定装置二置于右室流出道，Or, the first anchoring device is placed in the left atrium wall, and the second anchoring device is placed in the right ventricular outflow tract,
或，所述锚定装置一置于左心房壁外、所述锚定装置二置于右室流出道，Or, the first anchoring device is placed outside the left atrium wall, and the second anchoring device is placed in the right ventricular outflow tract,
或，所述锚定装置一置于冠状动脉系统的左主干、所述锚定装置二置于右室流出道，Or, the first anchoring device is placed in the left main trunk of the coronary artery system, and the second anchoring device is placed in the right ventricular outflow tract,
或，所述锚定装置一置于冠状动脉系统的左回旋支、所述锚定装置二置于右室流出道；Or, the first anchoring device is placed in the left circumflex artery of the coronary artery system, and the second anchoring device is placed in the right ventricular outflow tract;
桥接线收紧锚定装置一与锚定装置二距离以收紧左心房。The bridge wire tightens the distance between anchoring device one and anchoring device two to tighten the left atrium.
可选的，所述锚定装置一设为支架、固定于组织上的缝线。Optionally, the anchoring device is a stent or a suture fixed on the tissue.
优选的，所述锚定装置一设为垫片、编织网盘、棒状金属、棒状高分子、螺丝、铆钉或倒刺结构。进一步的，所述锚定装置二设为垫片、编织网盘、棒状金属、棒状高分子、螺丝、铆钉或倒刺结构。Preferably, the anchoring device is a gasket, a woven mesh disk, a rod-shaped metal, a rod-shaped polymer, a screw, a rivet or a barbed structure. Further, the second anchoring device is configured as a gasket, a woven mesh disk, a rod-shaped metal, a rod-shaped polymer, a screw, a rivet or a barbed structure.
本申请优点在于，本申请提供的多种锚定方式的二尖瓣修复装置，根据患者人体解剖结构特征，选取不同锚定位置，使得锚定装置一和锚定装置二位于左心房相对两侧，锚定装置一、锚定装置二、桥接线的方位角度以及所在平面可以调整到最佳角度，使得在桥接线收紧锚定装置一与锚定装置二距离以收紧左心房的治疗过程中，避免锚定装置一和锚定装置二发生偏移运动，避免磨损、破坏心脏组织。The advantage of this application is that the mitral valve repair device with multiple anchoring methods provided by this application selects different anchoring positions according to the anatomical structure characteristics of the patient's body, so that anchoring device one and anchoring device two are located on opposite sides of the left atrium. , the azimuth angle and plane of anchoring device one, anchoring device two, and bridge line can be adjusted to the optimal angle, so that the distance between anchoring device one and anchoring device two on the bridge line can be tightened to tighten the treatment process of the left atrium. In this way, the anchoring device 1 and the anchoring device 2 are prevented from shifting to avoid wear and damage to the heart tissue.
附图说明Description of the drawings
图1为锚定装置治疗二尖瓣返流原理示意图；Figure 1 is a schematic diagram of the principle of anchoring device to treat mitral regurgitation;
图2为现有锚定装置位置示意图；Figure 2 is a schematic diagram of the location of the existing anchoring device;
图3为锚定装置在左心房壁内示意图；Figure 3 is a schematic diagram of the anchoring device in the left atrial wall;
图4为锚定装置在左心房壁外示意图；Figure 4 is a schematic diagram of the anchoring device outside the left atrium wall;
图5为锚定装置置于主动脉根部原理示意图；Figure 5 is a schematic diagram of the principle of placing the anchoring device in the aortic root;
图6为锚定装置采用支架示意图；Figure 6 is a schematic diagram of the anchoring device using a bracket;
图7为锚定装置采用缝线示意图；Figure 7 is a schematic diagram of sutures used in the anchoring device;
图8为锚定装置一采用螺丝、锚定装置二采用编织网盘示意图。Figure 8 is a schematic diagram of the first anchoring device using screws and the second anchoring device using woven mesh.
具体实施方式Detailed ways
为使本申请更明显易懂，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 application more obvious and understandable, preferred embodiments are described in detail below along with the accompanying drawings.
本实施例提供的多种锚定方式的二尖瓣修复装置，对于两个锚定装置，视人体解剖结构，放置于不同位置达到治疗目的。锚定装置一10除了放置于心大静脉10内，也可置于：左心房壁100内(参见图3)，左心房壁外(参见图4)，冠状动脉系统(如左主干、左回旋支)等。锚定装置二14除了放置于房间隔，也可置于：主动脉内(如根部)(参见图5)，右室流出道等。锚定装置一10和锚定装置二14的不同位置组合包含以上提供的锚定装置一10和锚定装置二14位置的任何组合。This embodiment provides a mitral valve repair device with multiple anchoring methods. The two anchoring devices can be placed in different positions depending on the anatomical structure of the human body to achieve the purpose of treatment. In addition to being placed in the great cardiac vein 10, the anchoring device 10 can also be placed in: the left atrium wall 100 (see Figure 3), outside the left atrium wall (see Figure 4), the coronary artery system (such as the left main trunk, left circumflex branch) etc. In addition to being placed in the interatrial septum, the anchoring device 214 can also be placed in: the aorta (such as the root) (see Figure 5), right ventricular outflow tract, etc. Different position combinations of the anchoring device one 10 and the anchoring device two 14 include any combination of the positions of the anchoring device one 10 and the anchoring device two 14 provided above.
锚定装置一10与锚定装置二14通过桥接线12连接，桥接线12收紧锚定装置一10与锚定装置二14距离以收紧左心房，收紧左心房后，心脏的前后径减小并改善二尖瓣反流以及心房扩大以及心衰等，达到治疗的目的。The anchoring device one 10 and the anchoring device two 14 are connected through the bridge wire 12. The bridge wire 12 tightens the distance between the anchoring device one 10 and the anchoring device two 14 to tighten the left atrium. After tightening the left atrium, the front-to-back diameter of the heart Reduce and improve mitral regurgitation, atrial enlargement, heart failure, etc. to achieve the purpose of treatment.
在一种实施方式中，锚定装置一10可以采用现有置入用结构，比如基于激光切割或编织形成的心脏支架类、或采用部分支架(参见图6)，或采用缝线，固定于组织上(参见图7)。In one embodiment, the anchoring device 10 can adopt an existing insertion structure, such as a cardiac stent formed by laser cutting or weaving, or use a partial stent (see Figure 6), or use sutures to be fixed on the Organizationally (see Figure 7).
在另一种实施方式中，锚定装置一10和锚定装置二14均可采用各种结构和设计，如垫片、编织网盘、棒状金属(或棒状高分子)、螺丝、铆钉以及倒刺结构等，参见图8。锚定装置一10和锚定装置二14可以分别采用上述不同结构形成的各种组合。In another embodiment, the anchoring device 10 and the anchoring device 2 14 can adopt various structures and designs, such as gaskets, woven mesh disks, rod-shaped metal (or rod-shaped polymer), screws, rivets and inverted Thorn structure, etc., see Figure 8. The first anchoring device 10 and the second anchoring device 14 can adopt various combinations of the different structures mentioned above.
本申请提供的多种锚定方式的二尖瓣修复装置，根据患者人体解剖结构特征，选取不同锚定位置，使得锚定装置一10和锚定装置二14位于左心房相对两侧，锚定装置一、锚定装置二、桥接线的方位角度以及所在平面可以调整到最佳角度(模拟调整锚定装置一、锚定装置二的位置，选取最佳角度位置)，使得在桥接线12收紧锚定装置一10与锚定装置二14距离以收紧左心房的治疗过程中，避免锚定装置一10和锚定装置二14发生偏移运动，避免磨损、破坏心脏组织。The mitral valve repair device with multiple anchoring methods provided by this application selects different anchoring positions according to the anatomical structure characteristics of the patient's human body, so that the anchoring device 10 and the anchoring device 2 14 are located on opposite sides of the left atrium. The azimuth angle and plane of device one, anchoring device two, and bridge line can be adjusted to the best angle (simulate adjusting the positions of anchoring device one and two, and select the best angle position), so that when bridge line 12 is closed, During the treatment process of tightening the left atrium by tightening the distance between the anchoring device one 10 and the anchoring device two 14 , the anchoring device one 10 and the anchoring device two 14 are prevented from deviating and wearing and damaging the heart tissue.
从而可以有效缓解器械对心房壁的摩擦损伤，继而具有以下优点：This can effectively alleviate the friction damage caused by the device to the atrial wall, and has the following advantages:
1、本申请可以封闭穿刺心房壁造成的损伤；1. This application can seal the damage caused by puncture of the atrial wall;
2、本申请可以促进穿刺口的愈合；2. This application can promote the healing of the puncture site;
3、本申请可以固定固定管，保证器械不移位，有益于器械稳定发挥作用。3. This application can fix the fixed tube to ensure that the instrument does not shift, which is beneficial to the stable function of the instrument.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310920136.3ACN116869706A (en) | 2023-07-25 | 2023-07-25 | Mitral valve repairing device with multiple anchoring modes |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310920136.3ACN116869706A (en) | 2023-07-25 | 2023-07-25 | Mitral valve repairing device with multiple anchoring modes |
| Publication Number | Publication Date |
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| CN116869706Atrue CN116869706A (en) | 2023-10-13 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310920136.3APendingCN116869706A (en) | 2023-07-25 | 2023-07-25 | Mitral valve repairing device with multiple anchoring modes |
| Country | Link |
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| CN (1) | CN116869706A (en) |
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