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CN111904660B - Valve clamping device and valve clamping system - Google Patents

Valve clamping device and valve clamping system Download PDF

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Publication number
CN111904660B
CN111904660B CN202010192630.9A CN202010192630A CN111904660B CN 111904660 B CN111904660 B CN 111904660B CN 202010192630 A CN202010192630 A CN 202010192630A CN 111904660 B CN111904660 B CN 111904660B
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China
Prior art keywords
valve
clamping device
elastic body
valve clamping
clamping
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CN202010192630.9A
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CN111904660A (en
Inventor
张庭超
张伟伟
王泽涛
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Hangzhou Valgen Medtech Co Ltd
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Hangzhou Valgen Medtech Co Ltd
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Application filed by Hangzhou Valgen Medtech Co Ltd filed Critical Hangzhou Valgen Medtech Co Ltd
Priority to CN202010192630.9A priority Critical patent/CN111904660B/en
Priority to CN202310195744.2A priority patent/CN116211543A/en
Publication of CN111904660A publication Critical patent/CN111904660A/en
Priority to EP21770911.2A priority patent/EP4122426A4/en
Priority to US17/906,641 priority patent/US20230157819A1/en
Priority to BR112022018791A priority patent/BR112022018791A2/en
Priority to PCT/CN2021/081606 priority patent/WO2021185324A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The application relates to a valve clamping system, which comprises a valve clamping device and a conveying device, wherein the valve clamping device comprises a supporting part, and the supporting part comprises a connecting end and a free end which are oppositely arranged; at least one part of the supporting part is arranged in the adjusting part, one end of the adjusting part is sleeved outside the connecting end and is connected with the supporting part, and the other end of the adjusting part is provided with an opening; the clamping part is arranged around the outer side of the adjusting part; the driving part is connected with the clamping part to drive the clamping part to unfold or close around the adjusting part. The regulating part is provided with an open free end which is not limited by the sealing head, the axial deformation capacity of the regulating part is improved, the bending deformation capacity along the axial direction is enhanced, the regulating part is easily compressed into the sheath, the regulating part can adapt to blood vessels with different bending degrees during conveying, and the damage to the blood vessel wall is reduced. After the valve is implanted, the axial deformation of the adjusting part is not limited, so that the elastic fitting property of the valve leaflet and the adjusting part is improved, and the adaptability of the physiological structures of the valve leaflets of different patients is improved.

Description

瓣膜夹合装置及瓣膜夹合系统Valve clipping device and valve clipping system

技术领域technical field

本申请涉及植入医疗器械领域,尤其涉及一种瓣膜夹合装置及包括该瓣膜夹合装置的瓣膜夹合系统。The present application relates to the field of implanted medical devices, in particular to a valve clamping device and a valve clamping system including the valve clamping device.

背景技术Background technique

参阅图1,二尖瓣1是位于心脏左心房2与左心室3之间的单向阀,正常健康的二尖瓣1可以控制血液从左心房2流到左心室3,同时避免血液从左心室3流到左心房2。二尖瓣1包括一对瓣叶,称为前叶1a及后叶1b。前叶1a及后叶1b通过腱索4固定于左心室3的乳头肌上。正常情况下,心脏左心室3收缩时,前叶1a和后叶1b的边缘完全对合,避免血液从左心室3流到左心房2。参阅图2,当二尖瓣1的瓣叶或其相关结构发生器质性改变或功能性改变时,如腱索4部分断裂,二尖瓣1的前叶1a和后叶1b对合不良,由此,当心脏左心室3收缩时,二尖瓣1不能完全关闭,导致血液从左心室3反流至左心房2,从而引起一系列的病理生理改变,称为“二尖瓣反流”。Referring to Figure 1, the mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A normal and healthy mitral valve 1 can control the flow of blood from the left atrium 2 to the left ventricle 3 while preventing blood from flowing from the left atrium 2 to the left ventricle 3. The ventricle 3 flows to the left atrium 2 . The mitral valve 1 includes a pair of leaflets called an anterior leaflet 1a and a posterior leaflet 1b. The anterior lobe 1a and the posterior lobe 1b are fixed to the papillary muscle of the left ventricle 3 through the chordae 4 . Under normal circumstances, when the left ventricle 3 of the heart contracts, the edges of the anterior lobe 1a and the posterior lobe 1b are completely joined to prevent blood from flowing from the left ventricle 3 to the left atrium 2 . Referring to Figure 2, when the leaflets of mitral valve 1 or its related structures undergo organic or functional changes, such as partial rupture of the chordae 4, poor alignment of the anterior leaflet 1a and posterior leaflet 1b of the mitral valve 1, Therefore, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes called "mitral valve regurgitation" .

现有技术通过向二尖瓣植入瓣膜夹合装置,将一对可闭合的钳臂将前叶和后叶拉向彼此,减小或消除瓣叶间隙从而治疗二尖瓣反流。参阅图3和图4,现有的一种瓣膜夹合装置在两个钳臂30中增加了弹性体20,每侧的瓣叶被分别夹持在一侧钳臂30和弹性体20的一侧之间,通过弹性体20的变形来适应瓣叶的间距,从而调节钳臂30对瓣叶的牵拉程度。该弹性体20包括一个可变形的网状主体21,两端采用钢套等封头24固定,然后再固定在两个钳臂30之间的支撑杆上。然而,由于弹性体20的两端均通过封头24固定,在钳臂30闭合的时候,封头24限制了弹性体的轴向活动,弹性体只能径向被压缩,影响了弹性体的变形,从而增加了夹合装置在输送状态时的尺寸,不利于夹合装置在弯曲血管中的通过性,并且将导致夹合器植入后,弹性体不能完全贴合瓣叶,对不同患者的瓣叶生理结构的适应性较差。The prior art treats mitral valve regurgitation by implanting a valve clipping device into the mitral valve, with a pair of closable forceps arms pulling the anterior and posterior leaflets toward each other, reducing or eliminating the leaflet gap. Referring to Fig. 3 and Fig. 4, an existing valve clamping device adds an elastic body 20 to the two forceps arms 30, and the leaflets on each side are clamped on one side of the forceps arm 30 and the elastic body 20 respectively. Between the two sides, the distance between the leaflets is adapted by the deformation of the elastic body 20, thereby adjusting the pulling degree of the leaflets by the forceps arm 30. The elastic body 20 includes a deformable net-like main body 21, both ends of which are fixed by heads 24 such as steel sleeves, and then fixed on the support rod between the two pliers arms 30. However, since both ends of the elastic body 20 are fixed by the head 24, when the clamp arm 30 is closed, the head 24 restricts the axial movement of the elastic body, and the elastic body can only be compressed radially, which affects the elastic body. Deformation, thereby increasing the size of the clipping device in the delivery state, is not conducive to the passage of the clipping device in the curved blood vessel, and will cause the elastic body to not fully fit the valve leaflet after the clipper is implanted, which is different for different patients. The adaptability of the valve leaflet physiological structure is poor.

发明内容Contents of the invention

为了解决上述技术问题或者至少部分地解决上述技术问题,本申请提供了一种瓣膜夹合装置及包括该瓣膜夹合装置的瓣膜夹合系统。In order to solve the above technical problems or at least partly solve the above technical problems, the present application provides a valve clamping device and a valve clamping system including the valve clamping device.

第一方面,本申请提供了一种瓣膜夹合装置,包括:In a first aspect, the present application provides a valve clamping device, comprising:

支撑部,支撑部包括相对设置的连接端和自由端;a supporting part, the supporting part includes a connecting end and a free end arranged oppositely;

中空的调节部,支撑部的至少一部分设于调节部内,调节部的一端套设在连接端外侧并与支撑部连接,所述支撑部的自由端位于所述调节部内,并且所述自由端用于与输送装置可拆卸连接,调节部的另一端自由悬空;A hollow adjustment part, at least a part of the support part is arranged in the adjustment part, one end of the adjustment part is sleeved outside the connection end and connected with the support part, the free end of the support part is located in the adjustment part, and the free end is used for Due to the detachable connection with the conveying device, the other end of the adjustment part is free to hang;

夹合部,夹合部围设于调节部的外侧;A clamping part, the clamping part is surrounded by the outer side of the adjustment part;

驱动部,驱动部与夹合部连接,以驱动夹合部围绕调节部展开或闭合。The driving part is connected with the clamping part to drive the clamping part to expand or close around the adjusting part.

第二方面,本申请提供了一种瓣膜夹合系统,包括上述任一项的瓣膜夹合装置、以及输送装置,其中,输送装置包括:具有一定轴向长度的推送轴及活动地穿装在推送轴中的芯轴,推送轴与支撑部之间可拆卸连接,芯轴与驱动部相连,用于驱动夹合部相对于支撑部的展开和闭合。In a second aspect, the present application provides a valve clamping system, including any one of the valve clamping devices described above, and a delivery device, wherein the delivery device includes: a push shaft with a certain axial length and a movably mounted on The mandrel in the push shaft is detachably connected between the push shaft and the supporting part, and the mandrel is connected with the driving part for driving the expansion and closing of the clamping part relative to the supporting part.

本申请实施例提供的上述技术方案与现有技术相比至少具有如下优点:对于瓣膜夹合装置及包含该瓣膜夹合装置的瓣膜夹合系统,支撑部的至少一部分设于调节部的中空内,调节部的一端套设在连接端外侧并与支撑部连接,调节部的另一端自由悬空,自由悬空的这一端与支撑部及输送装置之间均无连接,不再受支撑部或输送装置的限制,提高了调节部的轴向变形能力,同时增强了其沿轴向的弯曲变形能力,因此当该瓣膜夹合装置被径向压缩到输送器中进行体内输送时,不仅易于被压缩入鞘,而且在血管中输送时,可以适应不同弯曲曲度的血管,从而利于输送器在血管中通过,由此减少了对血管壁的损伤。另,瓣膜夹合装置植入后,通过钳臂夹合瓣叶与调节部的过程中,因调节部的轴向形变不受限,可以提高瓣叶与调节部的弹性贴合性,继而提高了不同患者的瓣叶生理结构的适应性。Compared with the prior art, the above-mentioned technical solution provided by the embodiment of the present application has at least the following advantages: for the valve clamping device and the valve clamping system including the valve clamping device, at least a part of the support part is arranged in the hollow of the adjustment part , one end of the adjustment part is sleeved outside the connection end and connected with the support part, the other end of the adjustment part is free to hang in the air. The limitation of the adjustment part improves the axial deformation ability of the adjustment part, and at the same time enhances its bending deformation ability in the axial direction. Therefore, when the valve clamping device is radially compressed into the delivery device for in vivo delivery, it is not only easy to be compressed into the The sheath, and when delivered in blood vessels, can adapt to blood vessels with different curvatures, thereby facilitating the passage of the delivery device in blood vessels, thereby reducing damage to the blood vessel walls. In addition, after the valve clamping device is implanted, during the process of clamping the valve leaflet and the adjustment part with the forceps arms, since the axial deformation of the adjustment part is not limited, the elastic fit between the valve leaflet and the adjustment part can be improved, and then the The adaptability of valve leaflet physiological structure in different patients.

附图说明Description of drawings

此处的附图被并入说明书中并构成本说明书的一部分,示出了符合本发明的实施例,并与说明书一起用于解释本发明的原理。The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description serve to explain the principles of the invention.

为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,对于本领域普通技术人员而言,在不付出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, In other words, other drawings can also be obtained from these drawings without paying creative labor.

图1是二尖瓣正常状态时的示意图;Fig. 1 is the schematic diagram when the mitral valve is in a normal state;

图2是二尖瓣出现病变时的示意图;Figure 2 is a schematic diagram of mitral valve disease;

图3和图4是现有技术中的瓣膜夹合装置的结构示意图;Fig. 3 and Fig. 4 are the structural schematic diagrams of the valve clamping device in the prior art;

图5是依据本申请第一实施例的一种瓣膜夹合装置的结构示意图;Fig. 5 is a schematic structural view of a valve clamping device according to the first embodiment of the present application;

图6是图5中调节部和支撑部组合后的结构示意图;Fig. 6 is a schematic structural diagram of the combination of the adjustment part and the support part in Fig. 5;

图7是图5中支撑部的结构示意图;Fig. 7 is a schematic structural view of the supporting part in Fig. 5;

图8是图5中调节部的结构示意图;Fig. 8 is a schematic structural view of the regulating part in Fig. 5;

图9A是一示例中制备图5中调节部的管体的结构示意图;Fig. 9A is a structural schematic diagram of preparing the tube body of the regulating part in Fig. 5 in an example;

图9B是经图9A中的管体切割定型后的框架结构的结构示意图;Fig. 9B is a schematic structural view of the frame structure after the pipe body in Fig. 9A has been cut and shaped;

图9C是通过切割制备的一示例弹性主体的结构示意图;Figure 9C is a schematic diagram of the structure of an exemplary elastic body prepared by cutting;

图9D是通过切割制备的另一示例弹性主体的结构示意图;Figure 9D is a schematic structural view of another exemplary elastic body prepared by cutting;

图9E是图9D中弹性主体近端部分的局部示意图;Figure 9E is a partial schematic view of the proximal portion of the elastic body in Figure 9D;

图9F是通过切割制备的再一示例弹性主体的结构示意图;Fig. 9F is a schematic structural view of yet another example elastic body prepared by cutting;

图10A是图5中调节部的一示例网状结构的示意图;Fig. 10A is a schematic diagram of an example mesh structure of the regulating part in Fig. 5;

图10B是图5中调节部的另一示例网状结构的示意图;Fig. 10B is a schematic diagram of another exemplary mesh structure of the regulating part in Fig. 5;

图11是图5中一示例的具有环状结构的调节部的局部示意图;Fig. 11 is a partial schematic diagram of an example of an adjusting part having a ring structure in Fig. 5;

图12是图5中夹合部和驱动部组合后的结构示意图;Fig. 12 is a schematic structural view of the combination of the clamping part and the driving part in Fig. 5;

图13是图5中支撑部与基座配合的结构示意图;Fig. 13 is a schematic diagram of the structure of the cooperation between the support part and the base in Fig. 5;

图14是图5中瓣膜夹合装置与输送装置配合的结构示意图;Fig. 14 is a schematic structural diagram of the cooperation between the valve clamping device and the delivery device in Fig. 5;

图15是图5中瓣膜夹合装置的支撑部与输送装置配合的结构示意图;Fig. 15 is a structural schematic diagram of the cooperation between the support part of the valve clamping device in Fig. 5 and the delivery device;

图16-图20是采用图5中瓣膜夹合装置经左心房顺行接近并修复二尖瓣的输送过程示意图;Fig. 16-Fig. 20 are schematic diagrams of the delivery process of using the valve clipping device in Fig. 5 to antegradely approach and repair the mitral valve through the left atrium;

图21是依据本申请第二实施例的一种瓣膜夹合装置的结构示意图;Fig. 21 is a schematic structural view of a valve clamping device according to the second embodiment of the present application;

图22是图21中调节部的结构示意图;Fig. 22 is a schematic structural view of the regulating part in Fig. 21;

图23是图22中调节部远端的局部示意图;Fig. 23 is a partial schematic diagram of the distal end of the adjustment part in Fig. 22;

图24A是依据本申请第三实施例的一种瓣膜夹合装置的结构示意图;Fig. 24A is a schematic structural view of a valve clamping device according to the third embodiment of the present application;

图24B是图24A中一优选瓣膜夹合装置的结构示意图;Fig. 24B is a schematic structural view of a preferred valve clamping device in Fig. 24A;

图25A是依据本申请第四实施例的一种瓣膜夹合装置的调节部的第一曲面侧的结构示意图;Fig. 25A is a schematic structural view of the first curved surface side of the adjustment part of a valve clamping device according to the fourth embodiment of the present application;

图25B是图25A中调节部的第二曲面侧的结构示意图;Fig. 25B is a schematic structural view of the second curved surface side of the adjustment part in Fig. 25A;

图25C是图25A中调节部的俯视图;Fig. 25C is a top view of the adjustment part in Fig. 25A;

图26A是依据本申请第五实施例的一种瓣膜夹合装置的结构示意图;Fig. 26A is a schematic structural view of a valve clamping device according to the fifth embodiment of the present application;

图26B是图26A中的瓣膜夹合装置径向压缩后部分收入输送装置中的结构示意图。Fig. 26B is a schematic structural view of the valve clipping device in Fig. 26A after being radially compressed and partially received in the delivery device.

具体实施方式Detailed ways

下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

在本发明的描述中,需要说明的是,术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”等仅用于描述目的,而不能理解为指示或暗示相对重要性。In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer" and the like are based on the orientation or positional relationship shown in the accompanying drawings, and are only for It is convenient to describe the present invention and simplify the description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and thus should not be construed as limiting the present invention. In addition, the terms "first", "second", etc. are used for descriptive purposes only, and should not be construed as indicating or implying relative importance.

在本发明的描述中,需要说明的是,在介入医疗器械领域,近端是指距离操作者较近的一端,而远端是指距离操作者较远的一端;轴向是指平行于医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便,并不能理解为对本发明的限制。In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the end parallel to the medical device. The direction of the line connecting the center of the distal end and the center of the proximal end of the instrument. The above definitions are only for the convenience of expression, and should not be construed as limiting the present invention.

参阅图5-图20,依据本发明第一实施例的一种瓣膜夹合装置100包括:支撑部110,支撑部110包括相对设置的连接端111和自由端112;中空的调节部120,支撑部110的至少一部分设于调节部120内,调节部120的一端121a套设在连接端111外侧并与支撑部110连接,调节部120的另一端121b自由悬空;夹合部130,夹合部130围设于调节部120的外侧;驱动部140,驱动部140与夹合部130连接,以驱动夹合部130围绕调节部120展开或闭合。5-20, a valve clamping device 100 according to the first embodiment of the present invention includes: a support part 110, the support part 110 includes a connecting end 111 and a free end 112 arranged oppositely; a hollow adjustment part 120, supporting At least a part of the part 110 is arranged in the adjusting part 120, and one end 121a of the adjusting part 120 is sleeved on the outside of the connecting end 111 and connected with the supporting part 110, and the other end 121b of the adjusting part 120 is free to hang; the clamping part 130, the clamping part 130 surrounds the outer side of the adjusting part 120 ; the driving part 140 , the driving part 140 is connected with the clamping part 130 to drive the clamping part 130 to expand or close around the adjusting part 120 .

对于上述瓣膜夹合装置100,支撑部110的至少一部分设于调节部120的中空内,调节部120的一端121a套设在连接端111外侧并与支撑部110连接,调节部120的另一端121b自由悬空,自由悬空的这一端不再受支撑部110或输送装置200的限制,提高了调节部120的轴向变形能力,同时增强了其沿轴向的弯曲变形能力,因此当该瓣膜夹合装置100被径向压缩到输送器中进行体内输送时,不仅易于被压缩入鞘,而且在血管中输送时,可以适应不同弯曲曲度的血管,从而利于输送器在血管中通过,由此减少了对血管壁的损伤。另,瓣膜夹合装置100植入后,通过钳臂131夹合瓣叶与调节部120的过程中,因调节部120的轴向形变不受限,可以提高瓣叶与调节部120的弹性贴合性,继而提高了不同患者的瓣叶生理结构的适应性。For the above-mentioned valve clamping device 100, at least a part of the support part 110 is arranged in the hollow of the adjustment part 120, and one end 121a of the adjustment part 120 is sleeved on the outside of the connection end 111 and connected with the support part 110, and the other end 121b of the adjustment part 120 Freely suspended, the freely suspended end is no longer restricted by the support part 110 or the delivery device 200, which improves the axial deformation capacity of the adjustment part 120, and at the same time enhances its axial bending deformation capacity, so when the valve is clamped When the device 100 is radially compressed into the delivery device for in vivo delivery, it is not only easy to be compressed into the sheath, but also can adapt to blood vessels with different curvatures during delivery in the blood vessel, thereby facilitating the passage of the delivery device in the blood vessel, thereby reducing damage to the vessel wall. In addition, after the valve clamping device 100 is implanted, during the process of clamping the valve leaflet and the adjustment part 120 by the forceps arm 131, since the axial deformation of the adjustment part 120 is not limited, the elastic fit between the valve leaflet and the adjustment part 120 can be improved. Compatibility, which in turn improves the adaptability of the valve leaflet physiological structure in different patients.

参阅图6和图7,支撑部110可以是两端面轴向贯通的圆管体,该圆管体的远端为连接端111,近端为自由端112。支撑部110的至少一部分设于调节部120的中空内,例如,支撑部110的自由端112位于调节部120内,该自由端112在输送状态下和展开状态下均位于调节部120内,不会外露出调节部120。支撑部110还设有轴向通孔状的穿设通道113,以与驱动部140和输送装置200联动配合。支撑部110的圆管体的管壁上设有至少两个卡位114,用于与输送装置200进行可拆卸连接。例如,输送装置200上的卡台221(参阅图14)卡入卡位114后,输送装置200与支撑部110卡合连接,可进行瓣膜夹合装置100的输送,当卡台221脱离卡位114后,输送装置200与瓣膜夹合装置100分离,并于体内释放。应当知晓,此处的支撑部110结构仅用作举例,并不是对本申请的限制,本领域的普通技术人员基于本申请的教导,采用的其他支撑部110的结构,均在本申请的保护范围内。Referring to FIG. 6 and FIG. 7 , the supporting part 110 may be a circular tube whose two ends axially pass through. The distal end of the circular tube is a connecting end 111 , and the proximal end is a free end 112 . At least a part of the support part 110 is located in the hollow of the adjustment part 120, for example, the free end 112 of the support part 110 is located in the adjustment part 120, and the free end 112 is located in the adjustment part 120 in the delivery state and the unfolded state. The adjustment part 120 will be exposed. The supporting part 110 is also provided with an axial through-hole-shaped passageway 113 for interlocking cooperation with the driving part 140 and the conveying device 200 . The tube wall of the round tube body of the support part 110 is provided with at least two locking positions 114 for detachable connection with the delivery device 200 . For example, after the card table 221 (see FIG. 14 ) on the delivery device 200 is locked into the card position 114, the delivery device 200 is engaged with the support part 110 to carry out the delivery of the valve clamping device 100. When the card table 221 is out of the card position After 114, the delivery device 200 is separated from the valve clamping device 100 and released in vivo. It should be known that the structure of the supporting part 110 here is only used as an example, and is not a limitation to the present application. Those of ordinary skill in the art based on the teaching of the present application, adopt other structures of the supporting part 110, which are all within the protection scope of the present application. Inside.

本申请的瓣膜夹合装置100在近端的自由端112无论是输送状态下,还是释放展开状态下,均位于中空的调节部120内,因此始终不会外露于输送装置200中或外露于心脏中,从而避免了血液的冲刷,尽量减少了植入后血栓的形成。且,在植入后,还避免了与瓣叶直接接触,伴随着瓣叶的长期搏动,避免了瓣叶磨损甚至穿孔,提高了植入患者的安全。In the valve clipping device 100 of the present application, the free end 112 of the proximal end is located in the hollow adjustment part 120 no matter in the delivery state or the released and expanded state, so it will never be exposed to the delivery device 200 or to the heart. In order to avoid the washing of blood and minimize the formation of thrombus after implantation. Moreover, after implantation, direct contact with the leaflets is avoided, and along with the long-term pulsation of the leaflets, wear and even perforation of the leaflets are avoided, which improves the safety of implanted patients.

参阅图6和图8,调节部120包括可变形的弹性主体123,该弹性主体123具有中空容纳腔体,至少一部分支撑部110设于该中空容纳腔体内。弹性主体123的一端121a与支撑部110连接,弹性主体123的另一端121b具有开口122并自由悬空。弹性主体123可变形,从而可适应不同瓣叶之间的间距,调节瓣膜夹合装置100对瓣叶的牵拉程度。弹性主体123的开口122用于穿装输送装置200的远端,应当理解的是,输送装置200的远端经开口122穿入弹性主体123的内腔后与支撑部110的近端(自由端)相连,而弹性主体123的远端的开口122与输送装置200的远端或支撑部110的近端(自由端)均不相连,即,弹性主体123的近端121b为自由悬空状态。由此,在输送过程或夹合瓣叶的过程中,当夹合部130闭合时,调节部120中的弹性主体123不受支撑部110或输送装置200的限制,在径向及轴向均可变形,变形程度较大,更利于输送,对瓣叶的适应能力更强;当解脱输送装置200的远端或支撑部110的近端(自由端)之间的连接后,调节部120的自由悬空的一端的变形能力更强,对瓣叶的适应能力更强。Referring to FIG. 6 and FIG. 8 , the adjusting part 120 includes a deformable elastic body 123 having a hollow cavity, and at least a part of the supporting part 110 is disposed in the hollow cavity. One end 121 a of the elastic body 123 is connected to the supporting part 110 , and the other end 121 b of the elastic body 123 has an opening 122 and is freely suspended. The elastic main body 123 is deformable so as to adapt to the distance between different valve leaflets and adjust the pulling degree of the valve leaflets by the valve clamping device 100 . The opening 122 of the elastic body 123 is used to wear the distal end of the delivery device 200. It should be understood that the distal end of the delivery device 200 penetrates the inner cavity of the elastic body 123 through the opening 122 and connects with the proximal end (free end) of the support part 110. ), and the opening 122 of the distal end of the elastic body 123 is not connected to the distal end of the delivery device 200 or the proximal end (free end) of the support portion 110, that is, the proximal end 121b of the elastic body 123 is in a free-suspending state. Thus, during the delivery process or the process of clamping the leaflets, when the clamping part 130 is closed, the elastic body 123 in the adjustment part 120 is not restricted by the support part 110 or the delivery device 200, and can be balanced in both the radial direction and the axial direction. Deformable, with a large degree of deformation, more conducive to delivery, and stronger adaptability to valve leaflets; when the connection between the distal end of the delivery device 200 or the proximal end (free end) of the support part 110 is released, the adjustment part 120 The free-hanging end has a stronger deformation ability and a stronger adaptability to the leaflet.

在其中一个实施例中,该弹性主体123为网状结构,网状结构可以由形状记忆材料经编织而成,例如可选用超弹性的镍钛合金材料进行编织及经过热定型处理后,形成压缩状态和展开状态,在输送装置200中保持为压缩状态,在体内释放后保持展开状态。在其中一个实施例中,网状结构的弹性主体123采用编织而成,在制作时,先将12-36根直径为0.02-0.15mm的镍钛丝缠绕在衬棒上,编织形成一个筒状的编织网,具有相对设置的近端和远端。在近端,多个网丝124弯折绕回形成多个环形,多个环形围合形成近端边缘,然后将一根金属丝依次穿过近端的所有环形之后适度收紧金属丝,但保留尺寸适中的开口。然后将定型模具自编织网的远端塞入,再将远端的镍钛丝用金属丝缠绕成一束;将编织网和定型模具放入电加热式循环空气箱式炉于450-650℃(优选500℃)条件下进行热定型处理10-20分钟;取出冷却至室温后,拆除近端和远端的金属丝,并取出定型模具,将远端的所有镍钛丝塞入不锈钢制成的封头中,进行压接或焊接,得到网状结构的弹性主体123。In one of the embodiments, the elastic body 123 is a mesh structure, and the mesh structure can be woven from a shape memory material, for example, a superelastic nickel-titanium alloy material can be woven and heat-set to form a compressed state and the deployed state, which remain in the compressed state in the delivery device 200 and remain in the deployed state after release in vivo. In one of the embodiments, the elastic main body 123 of the network structure is braided. During manufacture, 12-36 nickel-titanium wires with a diameter of 0.02-0.15mm are wound on the liner rods, and the weaving forms a cylindrical shape. A woven mesh having oppositely disposed proximal and distal ends. At the proximal end, a plurality of mesh wires 124 are bent back to form a plurality of rings, and the plurality of rings are surrounded to form a proximal edge, and then a metal wire is passed through all the rings of the proximal end in order to tighten the wire appropriately, but Keep a decent size opening. Then the shaping mold is inserted from the far end of the braided mesh, and the nickel-titanium wire at the far end is wound into a bundle with a wire; the braided mesh and the shaping mold are put into an electric heating type circulating air box furnace at 450-650°C ( Preferably heat setting treatment at 500°C) for 10-20 minutes; take it out and cool to room temperature, remove the metal wires at the proximal and distal ends, take out the shaping mold, and insert all the nickel-titanium wires at the far end into stainless steel In the head, crimping or welding is performed to obtain the elastic main body 123 with a network structure.

参阅图9A和9B,弹性主体123还可以是框架结构,框架结构由不锈钢、合金、聚氯乙烯等较硬的金属或高分子材料切割而成。切割后的弹性主体123内表面光滑平整,避免在弹性主体123内部形成血栓并保证固定件220(参阅图14)可以顺利的从弹性主体123的开口122顺利撤出。切割方式可以采用线切割,也可以采用激光切割,优选采用激光切割的方式。制作时,先采用激光切割机将镍钛管126切割成所需要的形状。将切割所得到的镍钛件压入具有一定形状的定型模具内。然后将镍钛件和定型模具放入电加热式循环空气箱式炉于450-650℃(优选500℃)条件下进行定型热处理10-20分钟;取出冷却至室温后,拆除定型模具,得到定型后的弹性主体123,其为框架结构,包括多根径向间隔排布、轴向延伸的支杆127,多个支杆127的近端聚拢形成自由悬空的近端边缘。多个支杆127的远端汇聚并焊接于支撑部110上。镍钛管是具有一定壁厚的管材,具体的,镍钛管的壁厚小于1mm,优选0.02-0.15mm,并具有一定的柔性和刚性。Referring to FIGS. 9A and 9B , the elastic body 123 can also be a frame structure, and the frame structure is cut from relatively hard metal or polymer materials such as stainless steel, alloy, and polyvinyl chloride. The inner surface of the elastic main body 123 after cutting is smooth and flat, avoiding thrombus formation inside the elastic main body 123 and ensuring that the fixing member 220 (refer to FIG. 14 ) can be smoothly withdrawn from the opening 122 of the elastic main body 123 . The cutting method can be wire cutting or laser cutting, preferably laser cutting. During production, the nickel-titanium tube 126 is first cut into the desired shape by using a laser cutting machine. The nickel-titanium parts obtained by cutting are pressed into a shaping mold with a certain shape. Then put the nickel-titanium parts and the shaping mold into an electric heating circulating air box furnace at 450-650°C (preferably 500°C) for heat treatment for shaping for 10-20 minutes; take it out and cool to room temperature, remove the shaping mold to obtain the shaping The rear elastic body 123 is a frame structure and includes a plurality of struts 127 arranged at intervals in the radial direction and extending axially. The proximal ends of the plurality of struts 127 are gathered to form a freely suspended proximal edge. Distal ends of the plurality of struts 127 converge and are welded to the support portion 110 . The nickel-titanium tube is a pipe with a certain wall thickness. Specifically, the wall thickness of the nickel-titanium tube is less than 1 mm, preferably 0.02-0.15 mm, and has certain flexibility and rigidity.

参阅图9C,弹性主体123为切割形成的框架结构,由多个支杆127配合连接形成,该弹性主体123的近端121b为开放结构,该框架结构在近端121b处的所有支杆127的近端边缘围合形成上述开口122。Referring to Fig. 9C, the elastic body 123 is a frame structure formed by cutting, which is formed by a plurality of struts 127 being connected together. The proximal end 121b of the elastic body 123 is an open structure. The opening 122 is enclosed by the proximal edge.

参阅图9D和9E,弹性主体123仍为框架结构,由多个支杆127配合连接形成,该弹性主体123的近端121b为开放结构,近端121b处的每个支杆127上还可设有通孔127a,通孔127a之间通过柔性的线129以串联各通孔127a形成开口122。Referring to Figures 9D and 9E, the elastic main body 123 is still a frame structure, formed by a plurality of struts 127 connected together, the proximal end 121b of the elastic main body 123 is an open structure, and each strut 127 at the proximal end 121b can also be provided with There are through holes 127a, and flexible wires 129 are passed between the through holes 127a to connect the through holes 127a in series to form the opening 122 .

参阅图9F,弹性主体123仍为框架结构,由多个支杆127配合连接形成,该弹性主体123的近端121b为开放结构,该框架结构的相邻支杆127之间可切割后彼此交联,例如,近端121b边缘处的相邻支杆127之间切割后彼此交联形成环状结构129。Referring to FIG. 9F, the elastic body 123 is still a frame structure formed by a plurality of struts 127 that are connected together. The proximal end 121b of the elastic body 123 is an open structure. Adjacent struts 127 of the frame structure can be cut and intersected with each other. For example, adjacent struts 127 at the edge of the proximal end 121b are cross-linked to form a ring structure 129 after cutting.

当然,调节部120的弹性主体123还可以是其他具有弹性的中空结构,例如,弹性主体123可以是致密结构或多孔结构,致密结构为硅胶体,多孔结构为海绵体,致密结构或多孔结构的近端边缘形成开口122用于供输送装置200的远端穿入弹性主体123的内腔。Of course, the elastic body 123 of the adjustment part 120 can also be other elastic hollow structures, for example, the elastic body 123 can be a dense structure or a porous structure, the dense structure is silica colloid, the porous structure is sponge body, the dense structure or the porous structure The proximal edge forms an opening 122 for the distal end of the delivery device 200 to pass through the lumen of the elastic body 123 .

弹性主体123的形状选自柱形、锥形、球形、扁球形、椭球形、扇球形或葫芦形中的至少一种,也可以是多种形状的组合。为避免弹性主体123影响夹持臂151和钳臂131与支撑部110之间的相对开合,避免影响对瓣叶的夹持效果,弹性主体123靠近远端的部分的直径应小于弹性主体123其他部分的直径。例如,在图8所示的实施方式中,弹性主体123的中部为柱状,两头为锥体,且两头的锥体的锥角相同。可以理解的是,在其他实施例中,弹性主体123也可以为其它的任何形状,只要远端的直径不影响夹持效果即可。例如,图10A所示的两端锥角相同的纺锤形结构,或者图10B所示的两端的锥角不同的结构。The shape of the elastic body 123 is selected from at least one of cylindrical, conical, spherical, oblate spheroidal, ellipsoidal, fan-shaped or gourd-shaped, and can also be a combination of multiple shapes. In order to prevent the elastic main body 123 from affecting the relative opening and closing between the clamping arm 151 and the forceps arm 131 and the support part 110, and avoid affecting the clamping effect on the leaflet, the diameter of the part of the elastic main body 123 near the distal end should be smaller than that of the elastic main body 123 diameter of other parts. For example, in the embodiment shown in FIG. 8 , the middle part of the elastic body 123 is columnar, and the two ends are cones, and the cone angles of the two cones are the same. It can be understood that, in other embodiments, the elastic body 123 can also be in any other shape, as long as the diameter of the distal end does not affect the clamping effect. For example, a spindle-shaped structure with the same taper angle at both ends as shown in FIG. 10A , or a structure with different taper angles at both ends as shown in FIG. 10B .

上述调节部120包括近端和远端,在其中一个实施例中,弹性主体123的近端边缘套设一中空的圈套结构(图中未示出)形成开口,该圈套结构可以是现有的封头结构。圈套结构可以是环形或多边形,可以是不锈钢等硬质材料制成,从而将网状结构的网丝或者框架结构的支杆适当向中心轴处收拢,但是不闭合,从而在圈套结构的中心处形成一开口122。在另一个实施例中,弹性主体123的近端边缘围合形成上述开口122,开口122的尺寸小于或等于自由端112的尺寸,从而保证支撑部110的自由端112在压缩状态和展开状态均不会伸出调节部120。The adjustment part 120 includes a proximal end and a distal end. In one embodiment, a hollow snare structure (not shown) is sheathed on the proximal edge of the elastic body 123 to form an opening. The snare structure can be an existing Head structure. The snare structure can be annular or polygonal, and can be made of hard materials such as stainless steel, so that the wires of the mesh structure or the struts of the frame structure are properly gathered towards the central axis, but they are not closed, so that at the center of the snare structure An opening 122 is formed. In another embodiment, the proximal edge of the elastic body 123 surrounds the above-mentioned opening 122, and the size of the opening 122 is smaller than or equal to the size of the free end 112, so as to ensure that the free end 112 of the support part 110 is in both the compressed state and the expanded state. The adjustment part 120 will not protrude.

弹性主体123的近端边缘围合形成上述开口122的方式有多种,在本实施例的一具体实施方式中,网状结构123由镍钛合金丝经编织及热定型处理而成,并且网状结构123的网丝124在近端弯折绕回形成近端边缘,即所有网丝124在近端边缘的绕折部分围合形成开口122,绕折的形状可以根据需要设置,例如一次绕折,或多次缠绕形成至少一个环形后绕回等等,此处不再一一赘述。There are many ways to enclose the proximal edge of the elastic body 123 to form the above-mentioned opening 122. In a specific implementation manner of this embodiment, the mesh structure 123 is formed by braiding and heat setting of nickel-titanium alloy wires, and the mesh The mesh wire 124 of the shape structure 123 is bent back at the proximal end to form a proximal edge, that is, all the mesh wires 124 are surrounded by the folded part of the proximal edge to form an opening 122, and the shape of the winding can be set as required, for example, a winding Folding, or winding multiple times to form at least one loop and then winding back, etc., will not be repeated here.

弹性主体123的近端边缘围合形成开口122,取消了瓣膜夹合装置100的调节部120的近端封头,当夹合部130闭合时,弹性主体123不仅在径向及轴向均可变形,变形程度较大,更利于输送;另,弹性主体123不受封头对其每根网丝或支杆的轴向运动的限制,因此能适度卷曲或弯曲,从而完全贴合瓣叶,更好地适应不同患者的瓣叶生理结构;另,还可以避免现有技术中的近端封头部件在植入一段时间后脱落的风险;另,弹性主体123的远端与支撑部110相连,而近端处开口122开放,因此重心始终位于支撑部110的轴向(即弹性主体123的轴心线),因此自中心性较好,不易倾斜。The proximal edge of the elastic body 123 surrounds the opening 122, and the proximal head of the adjustment part 120 of the valve clamping device 100 is canceled. Deformation, the degree of deformation is relatively large, which is more conducive to delivery; in addition, the elastic body 123 is not restricted by the head to the axial movement of each mesh or strut, so it can be moderately curled or bent, so as to completely fit the leaflet, It can better adapt to the physiological structure of valve leaflets of different patients; in addition, it can also avoid the risk of falling off of the proximal head part in the prior art after being implanted for a period of time; in addition, the distal end of the elastic body 123 and the supporting part 110 connected, and the opening 122 at the proximal end is open, so the center of gravity is always located in the axial direction of the support part 110 (that is, the axis of the elastic body 123), so the self-centering is better and it is not easy to tilt.

进一步地,参阅图11,调节部120还可以包括设于近端边缘的环状结构125,以稳定开口122的形貌,网状结构123位于近端的所有网丝124与环状结构125缠绕连接。环状结构125由柔性或弹性材料制成,其丝径大于编织网状结构123的网丝的丝径,从而为网状结构123的开口122提供一定支撑力,但是不影响网状结构123的轴向变形能力及弯曲能力。Further, referring to FIG. 11 , the regulating part 120 may also include a ring structure 125 arranged at the edge of the proximal end to stabilize the shape of the opening 122 . connect. The annular structure 125 is made of flexible or elastic material, and its wire diameter is larger than the wire diameter of the mesh wire of the woven mesh structure 123, thereby providing a certain supporting force for the opening 122 of the mesh structure 123, but does not affect the opening 122 of the mesh structure 123. Axial deformation capacity and bending capacity.

调节部120的远端与支撑部110固定连接。具体地,弹性主体123的远端边缘外部套设一中空的圈套结构,圈套结构固定套设于支撑部110上。远端121a的圈套结构(例如图8中的远端121a处封头)与支撑部110通过焊接、粘结、螺纹连接、压接、螺栓锁紧等常见的可拆卸或不可拆卸连接方式固定在一起,例如,可以优先采用焊接连接。The distal end of the adjustment part 120 is fixedly connected with the support part 110 . Specifically, a hollow snare structure is sleeved on the outer edge of the distal end of the elastic body 123 , and the snare structure is fixedly sleeved on the support portion 110 . The snare structure at the distal end 121a (for example, the head at the distal end 121a in FIG. 8 ) and the support part 110 are fixed on the support part 110 by common detachable or non-detachable connection methods such as welding, bonding, threaded connection, crimping, and bolt locking. Together, for example, welded connections can preferably be used.

参阅图12和图13,夹合部130包括至少两个钳臂131,一般可以包括至少一组钳臂131,每一组钳臂131包括相对于调节部120对称设置的两个钳臂131,图中的夹合部130包括一组钳臂131,应当知晓,此处仅用作举例,本领域的普通技术人员可以根据需要选择合适的钳臂131数量,例如两组或更多组钳臂。驱动部140分别与每个钳臂131连接,例如驱动部140分别与一组钳臂131中的两个钳臂131连接,以驱动每个钳臂131围绕调节部120转动。可以理解的是,还可以根据需要在每组中设置三个或更多个钳臂131,例如,可以通过三个可相对开合的钳臂131来夹合三尖瓣的三片瓣叶,从而治疗三尖瓣反流。Referring to FIG. 12 and FIG. 13 , the clamping part 130 includes at least two pliers arms 131 , generally at least one set of pliers arms 131 , and each set of pliers arms 131 includes two pliers arms 131 arranged symmetrically with respect to the adjustment part 120 , The clamping portion 130 in the figure includes a set of tong arms 131. It should be known that this is only used as an example, and those of ordinary skill in the art can select the appropriate number of tong arms 131 according to needs, such as two or more sets of tong arms . The driving part 140 is respectively connected with each pliers arm 131 , for example, the driving part 140 is respectively connected with two pliers arms 131 in a group of pliers arms 131 to drive each pliers arm 131 to rotate around the adjustment part 120 . It can be understood that three or more forceps arms 131 can also be provided in each group according to needs, for example, three leaflets of the tricuspid valve can be clamped by using three forceps arms 131 that can be opened and closed relatively. To treat tricuspid regurgitation.

输送状态下,驱动部140驱动钳臂131围绕调节部120闭合,从而减少瓣膜夹合装置100的外径,利于输送;瓣膜夹合装置100在体内展开后,驱动部140驱动钳臂131将瓣叶夹持在钳臂131与调节部120之间,实现瓣叶夹持。In the delivery state, the driving part 140 drives the forceps arm 131 to close around the adjustment part 120, thereby reducing the outer diameter of the valve clamping device 100 and facilitating delivery; after the valve clamping device 100 is deployed in the body, the driving part 140 drives the forceps arm 131 to close the valve The leaflet is clamped between the forceps arm 131 and the adjustment part 120 to realize the clamping of the leaflet.

在本实施例的一优选实施方式中,瓣膜夹合装置100还包括抓持部,一般可以包括至少一组抓持臂151,每一组抓持臂151包括相对于调节部120对称设置的两个抓持臂151,抓持部(例如抓持臂151)设于夹合部130(例如钳臂131)与调节部120之间并可相对调节部120展开或闭合,抓持部及夹合部130均展开时,抓持部至少部分容置于夹合部130的内表面。当然,还可以根据需要在每组中设置三个或更多个抓持臂151,从而与钳臂131配合实现夹合功能。In a preferred implementation of this embodiment, the valve clamping device 100 further includes a gripping portion, which generally includes at least one set of gripping arms 151, and each set of gripping arms 151 includes two arms symmetrically arranged relative to the adjusting portion 120. A gripping arm 151, the gripping portion (such as the gripping arm 151) is located between the clamping portion 130 (such as the clamp arm 131) and the adjusting portion 120 and can be opened or closed relative to the regulating portion 120, the gripping portion and the clamping When the parts 130 are unfolded, the gripping part is at least partially accommodated on the inner surface of the clamping part 130 . Of course, three or more grasping arms 151 can also be provided in each group as required, so as to cooperate with the forceps arms 131 to realize the clamping function.

输送状态下,抓持部至少部分容纳在夹合部130的内表面中,即抓持臂151至少部分容纳在钳臂131的内表面中,从而减少了瓣膜夹合装置100的外径,利于输送;在钳臂131与抓持臂151配合夹持瓣叶后,凹入的内表面可以增加钳臂131与瓣叶的接触面积、并使得抓持臂151将瓣叶压入钳臂131的内表面中,增加对瓣叶的夹持力。In the delivery state, the grasping portion is at least partially accommodated in the inner surface of the clamping portion 130, that is, the grasping arm 151 is at least partially accommodated in the inner surface of the forceps arm 131, thereby reducing the outer diameter of the valve clamping device 100 and facilitating Delivery; after the forceps arm 131 cooperates with the grasping arm 151 to clamp the leaflet, the concave inner surface can increase the contact area between the forceps arm 131 and the leaflet, and make the grasping arm 151 press the leaflet into the forceps arm 131 In the inner surface, the clamping force on the leaflet is increased.

仍参阅图12和图13,瓣膜夹合装置100还包括与支撑部110固定连接的基座160,夹合部130转动连接于基座160上。具体地,基座160的近端与支撑部110的远端121a固定连接,应当说明,此处为了阐述方便将此部分定义为术语“基座”,实现该基座160功能的结构也可以是支撑部110的远端,即与支撑部110形成的一体结构,因此定义术语“基座”不应形成对本申请范围的限制。每一组中的每个钳臂131在基座160上通过枢轴132连接在一起,从而在驱动部140的驱动下,每个钳臂131彼此配合可以一起围绕调节部120展开和闭合。Still referring to FIG. 12 and FIG. 13 , the valve clamping device 100 further includes a base 160 fixedly connected to the supporting part 110 , and the clamping part 130 is rotatably connected to the base 160 . Specifically, the proximal end of the base 160 is fixedly connected to the distal end 121a of the support part 110. It should be noted that this part is defined as the term "base" for the convenience of explanation here, and the structure that realizes the function of the base 160 can also be The distal end of the support part 110 is an integral structure formed with the support part 110, so defining the term "base" should not limit the scope of the present application. Each pliers arm 131 in each group is connected together on the base 160 through a pivot 132 , so that under the drive of the driving part 140 , each pliers arm 131 cooperates with each other to expand and close around the adjustment part 120 together.

仍参阅图12和图13,驱动部140包括:驱动轴141、连接座142以及两个连杆143;其中,每个连杆143的一端与夹合部130连接,另一端与连接座142枢接;驱动轴141的一端与连接座142连接,另一端活动地穿装在基座160中。具体地,每一连杆143的一端与一钳臂131相连,另一端通过枢轴144连接于连接座142,即,每一钳臂131通过相应一侧的连杆143转动连接于驱动轴141的连接座142远端。驱动轴141活动地穿过基座160,当驱动轴141相对于基座160沿轴向滑动时,连杆143转动并带动钳臂131相对于基座160开合。Still referring to Fig. 12 and Fig. 13, the driving part 140 includes: a driving shaft 141, a connecting seat 142 and two connecting rods 143; wherein, one end of each connecting rod 143 is connected to the clamping part 130, and the other end is pivotally connected to the connecting seat 142 One end of the drive shaft 141 is connected to the connecting seat 142, and the other end is movably worn in the base 160. Specifically, one end of each connecting rod 143 is connected to a pliers arm 131, and the other end is connected to the connecting seat 142 through a pivot 144, that is, each pliers arm 131 is rotatably connected to the drive shaft 141 through the connecting rod 143 on the corresponding side. The far end of the connecting seat 142. The driving shaft 141 movably passes through the base 160 . When the driving shaft 141 slides axially relative to the base 160 , the connecting rod 143 rotates and drives the pliers arm 131 to open and close relative to the base 160 .

具体的,驱动部140包括至少一组连杆143,连杆143的数量设置与钳臂131的设置一一对应,例如图中采用两个钳臂131,则相对应地设置两个配合工作的连杆143。连杆143的远端通过转动销钉或螺栓144等方式转动连接于驱动轴141远端的连接座142上。当驱动轴141沿轴向相对于基座160朝远端滑动,带动连杆143运动,在连杆143的拉动下,钳臂131围绕销钉孔144转动而相对于基座160张开。当驱动轴141沿轴向相对于基座160朝近端滑动,连杆143拉动钳臂131围绕销钉孔144转动而相对于基座160闭合。Specifically, the driving part 140 includes at least one set of connecting rods 143, and the number of the connecting rods 143 is set in a one-to-one correspondence with the setting of the pliers arms 131. For example, if two pliers arms 131 are used in the figure, two matching working Connecting rod 143 . The distal end of the connecting rod 143 is rotatably connected to the connection seat 142 at the far end of the drive shaft 141 by rotating a pin or a bolt 144 or the like. When the drive shaft 141 slides axially relative to the base 160 toward the distal end, it drives the connecting rod 143 to move. Under the pull of the connecting rod 143 , the forceps arm 131 rotates around the pin hole 144 and opens relative to the base 160 . When the drive shaft 141 slides proximally relative to the base 160 in the axial direction, the connecting rod 143 pulls the forceps arm 131 to rotate around the pin hole 144 and close relative to the base 160 .

连接座142通过焊接等方式固定设置在驱动轴141的远端,连接座142开设一对销钉。销钉孔用于通过销钉144铰链连接连杆143,连杆143的另一端连接钳臂131,从而实现钳臂131相对于基座160的开合。连接座142的形状为半球体、球冠或弹头形等任一结构,以使瓣膜夹合装置100更容易在体内进行推送。驱动轴141与连接座142可以是一体结构,也可以是非一体结构。为保证植入后的安全性,驱动轴141及连接座142由聚酯、硅树脂、不锈钢、钴合金、钴铬合金或钛合金等生物相容性材料制成,优选为硬度较高的不锈钢或钴铬合金。The connecting seat 142 is fixedly arranged on the distal end of the driving shaft 141 by means of welding or the like, and the connecting seat 142 is provided with a pair of pins. The pin hole is used to hinge the connecting rod 143 through the pin 144 , and the other end of the connecting rod 143 is connected to the pliers arm 131 , so as to realize the opening and closing of the pliers arm 131 relative to the base 160 . The shape of the connecting seat 142 is any structure such as hemisphere, spherical cap or bullet, so as to make the valve clamping device 100 easier to push in the body. The driving shaft 141 and the connecting seat 142 can be an integral structure or a non-integral structure. In order to ensure the safety after implantation, the drive shaft 141 and the connecting seat 142 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel with high hardness. or cobalt chrome.

优选地,参见图12所示,瓣膜夹合装置100还包括设于基座160中的锁定部170,锁定部170限制驱动轴141与基座160的相对运动。在输送状态时,锁定部170限制驱动轴141与基座160的相对运动,从而保证夹合部130相对于调节部120和支撑部110始终保持闭合状态,避免夹合部130的意外展开;在到达二尖瓣附近后,解锁锁定部170对驱动轴141的限制,即可通过驱动部140驱动夹合部130相对于调节部120和支撑部110展开并承托瓣叶。可采用现有的任意适合的锁定部,此处不再赘述。Preferably, as shown in FIG. 12 , the valve clamping device 100 further includes a locking portion 170 disposed in the base 160 , and the locking portion 170 limits the relative movement between the driving shaft 141 and the base 160 . When in the delivery state, the locking part 170 restricts the relative movement between the drive shaft 141 and the base 160, thereby ensuring that the clamping part 130 remains closed relative to the adjusting part 120 and the supporting part 110, and avoids accidental deployment of the clamping part 130; After reaching near the mitral valve, unlock the restriction of the locking part 170 on the driving shaft 141 , and the clamping part 130 can be driven by the driving part 140 to expand relative to the adjusting part 120 and the supporting part 110 and support the valve leaflet. Any existing suitable locking portion can be used, and will not be repeated here.

参阅图14和图15,本实施例的瓣膜夹合系统包括上述瓣膜夹合装置100、以及输送装置200,其中,输送装置200包括:具有一定轴向长度的推送轴210及活动地穿装在推送轴210中的芯轴(图中未示出),推送轴210与支撑部110之间可拆卸连接,芯轴与驱动部140相连,用于驱动夹合部130相对于支撑部110的展开和闭合。本实施例中,驱动轴141的近端设置外螺纹,芯轴与驱动轴141之间螺纹连接,从而在患者体外通过芯轴来控制驱动轴141的轴向运动。应当知晓,此处列出的仅是输送装置的部分结构,其他部分可采用现有的任一适合的结构,此处不再赘述。Referring to Fig. 14 and Fig. 15, the valve clamping system of this embodiment includes the above-mentioned valve clamping device 100, and a delivery device 200, wherein the delivery device 200 includes: a push shaft 210 with a certain axial length and movably worn on The mandrel (not shown in the figure) in the push shaft 210 is detachably connected between the push shaft 210 and the support part 110, and the mandrel is connected with the drive part 140 for driving the expansion of the clamping part 130 relative to the support part 110 and closed. In this embodiment, the proximal end of the drive shaft 141 is provided with an external thread, and the mandrel is screwed to the drive shaft 141 , so that the axial movement of the drive shaft 141 is controlled by the mandrel outside the body of the patient. It should be known that what is listed here is only a part of the structure of the delivery device, other parts can adopt any existing suitable structure, and will not be repeated here.

具体地,支撑部110的近端外壁对称开设有连通于支撑部110的管腔的至少一卡位114,推送轴210远端设有一固定件220,固定件220包括两个分支,每个分支的末端为凸起的卡台221。在自然状态,两个分支均指向固定件220的中心轴处。组装时,将固定件220插入支撑部110中,再将输送装置200的芯轴插入推送轴210中,直至芯轴插入固定件220中,将固定件220的两个分支向外顶起,分支末端的卡台221卡入支撑部110的两个卡位114中,从而将支撑部110与固定件220连接,即,将瓣膜夹合装置100和输送装置200相连。当将芯轴自固定件220及推送轴210中撤出,两个分支恢复向内的自然状态,卡台221从支撑部110的卡位114中脱离,使得瓣膜夹合装置100与输送装置200之间解除连接。固定件220由镍钛等具有一定硬度及弹性的材料制成。推送轴210可采用多层复合管体。芯轴为不锈钢材料制成。Specifically, the proximal outer wall of the support part 110 is symmetrically provided with at least one locking position 114 communicating with the lumen of the support part 110, and a fixing part 220 is provided at the distal end of the pushing shaft 210. The fixing part 220 includes two branches, each branch The end is the raised card platform 221. In a natural state, both branches point to the central axis of the fixing member 220 . When assembling, insert the fixing part 220 into the supporting part 110, and then insert the mandrel of the conveying device 200 into the pushing shaft 210 until the mandrel is inserted into the fixing part 220, and the two branches of the fixing part 220 are lifted outwards, and the branches The clamping platform 221 at the end is snapped into the two clamping positions 114 of the supporting part 110 , so as to connect the supporting part 110 with the fixing part 220 , that is, connect the valve clamping device 100 and the delivery device 200 . When the mandrel is withdrawn from the fixing part 220 and the push shaft 210, the two branches return to the inward natural state, and the clamping table 221 is separated from the clamping position 114 of the support part 110, so that the valve clamping device 100 and the delivery device 200 Disconnect between. The fixing member 220 is made of nickel titanium and other materials with certain hardness and elasticity. The push shaft 210 can adopt a multi-layer composite pipe body. The mandrel is made of stainless steel.

支撑部110的内部设有通孔作为驱动轴141的穿设通道113,驱动轴141沿轴向滑动地穿设于支撑部110的穿设通道113内。驱动轴141的近端设置外螺纹,用于与输送装置200的芯轴连接,从而通过芯轴来控制驱动轴141的轴向运动。在夹合部130和抓持部150配合并夹紧瓣膜组织后,通过芯轴带动驱动轴141沿轴向向近端运动,驱动轴141带动连杆143转动,连杆143带动钳臂131相对于支撑部110合拢,直至钳臂131相对于支撑部110完全闭合,使瓣膜夹合装置100处于收拢闭合状态,坠于瓣膜下方。之后可以解脱芯轴与驱动轴141之间的连接,芯轴自固定件220之间后撤,卡台221自支撑部110的卡位114中分离,从而实现瓣膜夹合装置100和输送装置200的解脱。在解脱的过程中,由于瓣膜夹合装置100与输送装置200的连接处(即,解脱处)位于瓣膜夹合装置100的调节部120内,而调节部120的近端设有开放的开口122,没有部件会钩挂固定件220的分支末端的卡台221,便于瓣膜夹合装置100的释放。另外,解脱处设于调节部120的内部,不直接受到血液的冲刷,即可避免解脱处的机构失效,也可降低血栓形成的风险。A through hole is provided inside the supporting portion 110 as the passing channel 113 of the driving shaft 141 , and the driving shaft 141 is slidably inserted in the passing channel 113 of the supporting portion 110 in the axial direction. The proximal end of the drive shaft 141 is provided with an external thread for connecting with the mandrel of the delivery device 200, so that the axial movement of the drive shaft 141 is controlled by the mandrel. After the clamping part 130 and the grasping part 150 cooperate and clamp the valve tissue, the mandrel drives the drive shaft 141 to move proximally in the axial direction, and the drive shaft 141 drives the connecting rod 143 to rotate, and the connecting rod 143 drives the forceps arm 131 to face each other. Close up on the supporting part 110 until the forceps arm 131 is completely closed relative to the supporting part 110, so that the valve clamping device 100 is in a closed state and falls below the valve. Afterwards, the connection between the mandrel and the drive shaft 141 can be released, the mandrel is withdrawn from between the fixing parts 220, and the clamp table 221 is separated from the clamping position 114 of the support part 110, thereby realizing the valve clamping device 100 and the delivery device 200 relief. In the process of release, since the joint of the valve clamping device 100 and the delivery device 200 (that is, the release point) is located in the adjustment part 120 of the valve clamping device 100, and the proximal end of the adjustment part 120 is provided with an open opening 122 Therefore, there is no part that can hook the card platform 221 at the branch end of the fixing member 220 , which facilitates the release of the valve clamping device 100 . In addition, the release point is located inside the adjustment part 120 and is not directly washed by the blood, so that the mechanism failure of the release point can be avoided, and the risk of thrombus formation can also be reduced.

参阅图16-图20,以经左心房顺行接近并修复二尖瓣为例,阐述本申请的瓣膜夹合装置100的使用过程:Referring to Fig. 16-Fig. 20, taking the antegrade approach and repair of the mitral valve through the left atrium as an example, the use process of the valve clamping device 100 of the present application is explained:

第一步:如图16所示,通过可调弯鞘管等导引装置(图未示出)将驱动轴141及与其相连的瓣膜夹合装置100从左心房2推进,经过二尖瓣1到达左心室3;Step 1: As shown in FIG. 16 , push the drive shaft 141 and the valve clamping device 100 connected to it from the left atrium 2 through the guide device (not shown in the figure) such as an adjustable curved sheath, and pass through the mitral valve 1 reach the left ventricle 3;

第二步:调整瓣膜夹合装置100接近二尖瓣1的前叶1a和后叶1b;Step 2: adjust the valve clamping device 100 to approach the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1;

第三步:如图17所示,解锁基座160中的锁定部,向近端拉动芯轴及驱动轴141,驱动钳臂131相对于支撑部110张开,调整钳臂131方向,此时可通过X射线设备观察钳臂131与二尖瓣1的前叶1a和后叶1b的相对位置,使得钳臂131垂直于二尖瓣1的对合线;Step 3: As shown in Figure 17, unlock the locking part in the base 160, pull the mandrel and the drive shaft 141 to the proximal end, drive the forceps arm 131 to open relative to the support part 110, and adjust the direction of the forceps arm 131, at this time The relative position of the forceps arm 131 and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 can be observed through X-ray equipment, so that the forceps arm 131 is perpendicular to the line of apposition of the mitral valve 1;

第四步:如图18所示,向近端回撤整个瓣膜夹合装置100,使钳臂131在左心室3侧托住瓣叶1,释放两侧的抓持臂151,每侧的抓持臂151在心房侧压住瓣叶1并与该侧的钳臂131配合固定瓣叶1,实现瓣叶1的完整夹持;Step 4: As shown in Figure 18, withdraw the entire valve clamping device 100 proximally, so that the forceps arms 131 support the valve leaflet 1 on the side of the left ventricle 3, release the grasping arms 151 on both sides, and the grasping arms 151 on each side The holding arm 151 presses the leaflet 1 on the atrium side and cooperates with the forceps arm 131 on this side to fix the leaflet 1, so as to realize the complete clamping of the leaflet 1;

第五步:如图19所示,当二尖瓣1的前叶1a和后叶1b分别被夹持在一对钳臂131和抓持臂151之间,向远端推动芯轴及驱动轴141,从而驱动钳臂131闭合;Step 5: As shown in Figure 19, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are respectively clamped between a pair of forceps arms 131 and a grasping arm 151, push the mandrel and the drive shaft distally 141, thereby driving the clamp arm 131 to close;

第六步:解脱芯轴与驱动轴141之间的螺纹连接,并后撤芯轴,固定件220的两个分支恢复向中心轴靠拢的状态,卡台221自支撑部110的卡位114中分离,瓣膜夹合装置100与输送装置200之间的连接解除,之后将输送装置200撤出体外,得到如图20所示的植入状态,此时瓣膜夹合装置100将二尖瓣1的前叶1a和后叶1b拉向彼此,得到双孔化的二尖瓣,完成二尖瓣的缘对缘修复。Step 6: Release the threaded connection between the mandrel and the drive shaft 141, and withdraw the mandrel, the two branches of the fixing part 220 return to the state of moving closer to the central axis, and the clamp table 221 is in the clamping position 114 of the self-supporting part 110 Separated, the connection between the valve clamping device 100 and the delivery device 200 is released, and then the delivery device 200 is withdrawn from the body to obtain the implanted state as shown in Figure 20. The anterior leaflet 1a and posterior leaflet 1b are pulled toward each other, resulting in a bi-orificated mitral valve, completing the edge-to-edge repair of the mitral valve.

瓣膜夹合装置100植入后,具有弹性的调节部120填充于被夹持的二尖瓣1的前叶1a和后叶1b之间,且抵顶于钳臂131,调节部120的弹性主体123(例如网状结构或多孔结构等)对于搏动的瓣叶1具有缓冲作用,从而实现瓣膜夹合装置100对瓣叶1的牵拉程度可调节,以避免损伤瓣叶1;另,弹性主体123可以跟随瓣叶1的搏动而被挤压变形,产生的弹力将瓣叶1靠近弹性主体123的部分向远离基座160的方向推动,而此时因调节部120的开口122结构使得弹性主体123朝向近端的轴向运动不再受限,二尖瓣的前叶和后叶之间的夹合角度小于钳臂131之间的张开角度,能够减少瓣膜夹合装置100对瓣叶1的牵拉,使得瓣膜夹合装置100对瓣叶1的牵拉程度始终保持在合理范围内;另,弹性主体123可以缓冲血流对瓣膜夹合装置100内部的直接冲刷,避免瓣膜夹合装置100受到血液的连续冲刷而脱落,还可以避免血液在瓣膜夹合装置100的夹合部130之间的死角处(图5中的C处)淤积形成血栓;另,弹性主体123受到瓣膜的压力作用时,会产生一定程度的变形,且变形程度随着压力的增加而增大,从而避免抓取瓣叶1后,弹性主体123受到钳臂131的挤压力反过来作用于钳臂131上,保证释放后瓣膜夹合装置100对瓣叶1的抓取效果与释放前保持一致。After the valve clamping device 100 is implanted, the elastic regulating part 120 fills between the anterior leaflet 1a and the posterior leaflet 1b of the clamped mitral valve 1, and abuts against the forceps arm 131. The elastic body of the regulating part 120 123 (such as a mesh structure or porous structure, etc.) has a buffering effect on the pulsating valve leaflet 1, so that the pulling degree of the valve leaflet 1 by the valve clamping device 100 can be adjusted to avoid damage to the valve leaflet 1; in addition, the elastic body 123 can be squeezed and deformed following the pulsation of the leaflet 1, and the generated elastic force pushes the part of the leaflet 1 close to the elastic body 123 away from the base 160. The axial movement of 123 toward the proximal end is no longer restricted, and the clamping angle between the anterior leaflet and the posterior leaflet of the mitral valve is smaller than the opening angle between the forceps arms 131, which can reduce the impact of the valve clamping device 100 on the valve leaflet 1. The pulling of the valve clamping device 100 keeps the valve leaflet 1 within a reasonable range; in addition, the elastic body 123 can buffer the direct washing of the blood flow to the inside of the valve clamping device 100, avoiding the valve clamping device 100. 100 is subject to the continuous washing of blood and falls off, which can also prevent blood from stagnating and forming thrombus at the dead angle between the clamping parts 130 of the valve clamping device 100 (at C in FIG. 5 ); in addition, the elastic body 123 is under the pressure of the valve. When it works, it will produce a certain degree of deformation, and the degree of deformation will increase with the increase of the pressure, so as to prevent the elastic body 123 from being squeezed by the forceps arm 131 to act on the forceps arm 131 after the valve leaflet 1 is grasped. , to ensure that the gripping effect of the valve leaflet 1 by the valve clamping device 100 after the release is consistent with that before the release.

参阅图21-图23,与第一实施例的瓣膜夹合装置相比,依据本发明第二实施例的瓣膜夹合装置300的调节部320的网状结构位于远端321的所有网丝324固定套设于支撑部310上。即调节部320两端322和321均为没有封头的开放结构,调节部320在装配时直接将调节部322远端321的网丝324通过焊接、粘结、压接等常见的可拆卸或不可拆卸连接方式固定在支撑部310上,本实施例优选焊接连接。Referring to FIGS. 21-23 , compared with the valve clamping device of the first embodiment, the mesh structure of the adjustment part 320 of the valve clamping device 300 according to the second embodiment of the present invention is located at all mesh wires 324 of the distal end 321 The support portion 310 is fixedly sleeved on. That is to say, the two ends 322 and 321 of the adjustment part 320 are open structures without heads, and the adjustment part 320 directly connects the mesh wire 324 at the far end 321 of the adjustment part 322 by welding, bonding, crimping, etc. It is fixed on the support part 310 in a non-detachable connection, and in this embodiment, it is preferably welded.

因夹合部330(例如钳臂)的展开或闭合是绕着靠近调节部320远端侧的枢轴332(例如销钉)进行转动。当夹合部330闭合时,越靠近枢轴332处,其空间越小。当瓣叶被夹合部330夹持后,会有部分瓣叶1填充累积于D处的空间,不仅会影响瓣膜夹合装置的关闭,并且当无法及时发现该处的瓣叶1填充情况,强制关闭瓣膜夹合装置时,钳臂会导致该处的瓣叶1严重损伤。本实施例中,由于调节部320的远端321也为无封头的开放结构,在瓣膜夹合装置300关闭的过程中,调节部320能更好地顺应瓣叶1的变形。同时,由于调节部320减少了硬质的封头,从而增大该处的空间,有利于整个瓣膜夹合装置300在抓取到瓣叶1后更好地闭合。The opening or closing of the clamping part 330 (such as the forceps arm) rotates around the pivot 332 (such as a pin) near the distal end of the adjusting part 320 . When the clamping portion 330 is closed, the closer to the pivot 332 , the smaller the space. When the valve leaflets are clamped by the clamping part 330, some of the valve leaflets 1 will fill and accumulate in the space at D, which will not only affect the closing of the valve clamping device, but also when the filling of the valve leaflets 1 at this location cannot be found in time, When the valve clamping device is forcibly closed, the forceps arms will cause serious damage to the valve leaflet 1 there. In this embodiment, since the distal end 321 of the adjustment part 320 is also an open structure without a head, the adjustment part 320 can better conform to the deformation of the valve leaflet 1 during the closing process of the valve clamping device 300 . At the same time, since the adjustment part 320 reduces the hard sealing head, the space there is increased, which is beneficial for the entire valve clamping device 300 to close better after the valve leaflet 1 is grasped.

参阅图24A,与第一实施例的瓣膜夹合装置相比,依据本发明第三实施例的瓣膜夹合装置400的调节部420的网状结构的至少部分外表面施加覆膜。除此之外,还可以在夹合部430及抓持部450的至少部分外表面施加覆膜。该覆膜可以为编织网状结构,并开设多个网孔。覆膜后的调节部420、夹合部430及抓持部450的生物相容性更高,且摩擦力增强,因此对瓣叶的夹持效果较好。Referring to FIG. 24A , compared with the valve clamping device of the first embodiment, at least part of the outer surface of the mesh structure of the regulating portion 420 of the valve clamping device 400 according to the third embodiment of the present invention is coated. In addition, a coating can also be applied on at least part of the outer surfaces of the clamping portion 430 and the gripping portion 450 . The coating can be a woven mesh structure with multiple mesh holes. The regulating part 420 , the clamping part 430 and the grasping part 450 after film coating have higher biocompatibility and enhanced frictional force, so the clamping effect on the leaflet is better.

例如参阅图24B,抓持臂451和钳臂431外部分别覆盖有第一覆膜和第二覆膜,调节部420的弹性主体外部覆盖有第三覆膜。三者的开孔率大小关系为:第三覆膜的开孔率<第一覆膜的开孔率<第二覆膜的开孔率。开孔率是指开孔面积占整个覆膜面积的百分比。第二覆膜的开孔率较大,使得第二覆膜相较于第一覆膜具有更佳的弹性及延伸率,当覆盖有第二覆膜的钳臂相对于固定基座开合时,第二覆膜能够跟随钳臂的开合而产生相应的弹性变形,第二覆膜始终贴附于钳臂上。第三覆膜的开孔率最小,使得弹性主体基本可以阻碍血流通过。For example, referring to FIG. 24B , the grasping arm 451 and the forceps arm 431 are respectively covered with a first film and a second film, and the outside of the elastic body of the adjustment part 420 is covered with a third film. The relationship between the porosity of the three is: the porosity of the third coating<the porosity of the first coating<the porosity of the second coating. The opening ratio refers to the percentage of the opening area to the entire coating area. The opening ratio of the second coating is larger, so that the second coating has better elasticity and elongation than the first coating. When the forceps arm covered with the second coating is opened and closed relative to the fixed base , the second coating can produce corresponding elastic deformation following the opening and closing of the pliers arms, and the second coating is always attached to the pliers arms. The opening ratio of the third coating is the smallest, so that the elastic body can basically block the passage of blood.

第一覆膜及第二覆膜上的网孔可以通过血液并防止血栓通过,第三覆膜上的网孔既不可以通过血液也不可以通过血栓。第一覆膜能够允许血液渗透通过,不影响血液自左心房至左心室的正常流动,避免血液滞留于左心房中,从而减少了血液压力对左心房腔体的损伤;第一覆膜还可以增大抓持臂与血液的接触面积,以对流入的血流起到缓冲作用,从而尽可能避免流入的血流冲击瓣膜夹合装置造成抓持臂变形而导致滑脱。第二覆膜可以使得血流在左心房内及左心室之间正常流通,从而减小左心房与左心室之间的血液压力差;第二覆膜还能将极少量通过第一覆膜进入瓣膜夹合装置内部的血栓阻挡下来而滞留于瓣膜夹合装置中,防止血栓进入左心室并进入人体血液循环诱发中风。The mesh holes on the first covering film and the second covering film can pass blood and prevent thrombus from passing through, and the mesh holes on the third covering film can pass neither blood nor thrombus. The first coating can allow blood to permeate through without affecting the normal flow of blood from the left atrium to the left ventricle, avoiding blood stagnation in the left atrium, thereby reducing the damage of blood pressure to the cavity of the left atrium; the first coating can also The contact area between the grasping arm and the blood is increased to buffer the inflowing blood flow, so as to avoid as much as possible the inflowing blood flow impacting the valve clamping device and causing the grasping arm to deform and cause slippage. The second membrane can make blood flow in the left atrium and between the left ventricle normally, thereby reducing the blood pressure difference between the left atrium and the left ventricle; The thrombus inside the valve clamping device is blocked and stays in the valve clamping device, preventing the thrombus from entering the left ventricle and entering the blood circulation of the human body to induce stroke.

具有第三覆膜的弹性主体不仅增加生物相容性,避免组织过敏、炎症反应,提高产品安全性,更主要的是,具有第三覆膜的弹性主体还能够在瓣叶的心房侧形成人工屏障,阻挡血液中的血栓,闭合整个瓣膜夹合装置朝向心房侧的开口,避免血液在瓣膜夹合装置的内部死角处的反复冲刷形成血栓,从而避免血栓。The elastic body with the third coating not only increases biocompatibility, avoids tissue allergies and inflammatory reactions, and improves product safety, but more importantly, the elastic body with the third coating can also form an artificial The barrier blocks the thrombus in the blood, closes the opening of the whole valve clamping device towards the atrium side, and prevents the blood from repeatedly scouring the inner dead corner of the valve clamping device to form a thrombus, thereby avoiding thrombus.

第一覆膜、第二覆膜及第三覆膜均可以由聚对苯二甲酸乙二醇酯、聚丙烯、聚四氟乙烯、聚氨酯等高分子材质制成,三者的材料可以相同也可以不同,本实施例中,三者均由PET制成。The first covering film, the second covering film and the third covering film can all be made of macromolecular materials such as polyethylene terephthalate, polypropylene, polytetrafluoroethylene, polyurethane, and the materials of the three can be the same or Can be different, in this embodiment, all three are made of PET.

参阅图25A-图25C,与第一实施例的瓣膜夹合装置相比,依据本发明第四实施例的瓣膜夹合装置的调节部520具有自由悬空端和远端封头521,该自由悬空端处可以具有开口522,该调节部520包括多个第一曲面520A和多个第二曲面520B,第一曲面520A与第二曲面520B彼此相邻,并圆滑连接在一起,即第一曲面520A只与第二曲面520B相邻,第二曲面520B也只与第一曲面520A相邻,相对设置的两个第一曲面520A分别面向一个钳臂,第二曲面520B的面积大于第一曲面520A的面积。Referring to Fig. 25A-Fig. 25C, compared with the valve clamping device of the first embodiment, the adjustment part 520 of the valve clamping device according to the fourth embodiment of the present invention has a free hanging end and a distal end cap 521, the free hanging There may be an opening 522 at the end, and the adjusting part 520 includes a plurality of first curved surfaces 520A and a plurality of second curved surfaces 520B, the first curved surfaces 520A and the second curved surfaces 520B are adjacent to each other and smoothly connected together, that is, the first curved surfaces 520A It is only adjacent to the second curved surface 520B, and the second curved surface 520B is only adjacent to the first curved surface 520A. The two opposite first curved surfaces 520A are respectively facing one arm of the forceps. The area of the second curved surface 520B is larger than that of the first curved surface 520A. area.

本实施例中,面积相对较小的第一曲面520A正对着钳臂,面积相对较大的第二曲面520B圆滑连接在两个第一曲面520A之间,随着瓣膜夹合装置的闭合过程,调节部的第一曲面520A受到钳臂与瓣叶的挤压,调节部沿着第二曲面520B的方向延展,逐渐贴合于瓣叶,从而更好地适应瓣叶的形状,并增加了第一曲面520A与瓣叶之间的接触面积,从而减少了瓣膜夹合装置与瓣叶之间的间隙,减缓了血流并阻碍血流对瓣膜夹合装置的冲刷。优选地,第一曲面520A的曲度还可以大于第二曲面520B的曲度,使得调节部呈现扁平的椭球状,避免影响钳臂的闭合。进一步地,在这种实施方式中,当钳臂闭合时,受到钳臂和瓣叶的挤压,调节部第一曲面520A受到压力,调节部沿着第二曲面520B的方向延展,由于调节部的第一端开放设置,不会钩挂输送系统远端,从而能够保证瓣膜夹合装置在调节部发生任意变形的情况下都从瓣膜夹合装置的输送装置连接处脱离。In this embodiment, the first curved surface 520A with a relatively small area is facing the forceps arm, and the second curved surface 520B with a relatively large area is smoothly connected between the two first curved surfaces 520A. , the first curved surface 520A of the adjustment part is squeezed by the forceps arm and the leaflet, and the adjustment part extends along the direction of the second curved surface 520B, and gradually fits on the leaflet, thereby better adapting to the shape of the leaflet and increasing the The contact area between the first curved surface 520A and the valve leaflets reduces the gap between the valve clamping device and the valve leaflets, slows down the blood flow and prevents the blood flow from scouring the valve clamping device. Preferably, the curvature of the first curved surface 520A may be greater than the curvature of the second curved surface 520B, so that the adjustment part presents a flat ellipsoid shape, so as to avoid affecting the closing of the pliers arms. Further, in this embodiment, when the forceps arms are closed, the first curved surface 520A of the regulating part is pressed by the pressure of the forceps arms and the leaflets when the forceps arms are closed, and the regulating part extends along the direction of the second curved surface 520B. The first end of the valve is open, and will not hook the distal end of the delivery system, thereby ensuring that the valve clamping device is detached from the connection of the delivery device of the valve clamping device in the event of any deformation of the adjustment part.

参阅图26A及图26B,与第一实施例的瓣膜夹合装置相比,依据本发明第五实施例的瓣膜夹合装置600的调节部620的结构与实施例一的调节部120结构相同,区别在于夹合部630和抓持部650配合以抓取瓣叶的方式不同。第五实施例中,夹合部630包括一组可相对于支撑部610及调节部620展开或闭合的钳臂631,抓持部650包括一对抓持臂651,且抓持部650位于夹合部630和调节部620之间。Referring to FIG. 26A and FIG. 26B , compared with the valve clamping device of the first embodiment, the structure of the adjusting part 620 of the valve clamping device 600 according to the fifth embodiment of the present invention is the same as that of the adjusting part 120 of the first embodiment. The difference lies in the manner in which the clamping part 630 cooperates with the gripping part 650 to grab the leaflet. In the fifth embodiment, the clamping part 630 includes a set of clamp arms 631 that can be expanded or closed relative to the supporting part 610 and the adjusting part 620, the gripping part 650 includes a pair of gripping arms 651, and the gripping part 650 is located Between the joint part 630 and the adjustment part 620.

输送时,夹合部630、抓持部650和调节部620均收容在输送装置200的远端之中,将输送装置200通过经心尖的途径送入左心室后跨过二尖瓣瓣口到达左心房,回撤输送装置200,使得调节部620和抓持部650逐渐伸出输送装置200并展开于左心房内;继续回撤输送装置200直至夹合部630也自输送装置200中伸出并展开于左心室内;然后通过驱动部向远端推送夹合部630,将二尖瓣的前叶和后叶分别承托于夹合部630的两个钳臂631的内表面,向近端回撤抓持部650及调节部620,即,驱动抓持部650向夹合部630的方向运动,从而将瓣叶捕获在抓持部650与夹合部630之间,然后再驱动夹合部630相对于调节部620和支撑部610闭合,从而将前叶和后叶分别固定在一个钳臂631和与该钳臂631对应设置的一个抓持臂651之间,然后向远端推送输送装置200直至将瓣膜夹合装置600逐渐收拢闭合;解脱瓣膜夹合装置和输送装置200之间的连接,从而将瓣膜夹合装置植入在二尖瓣上,将二尖瓣的前叶和后叶拉向彼此形成双孔化结构。During delivery, the clamping part 630, the grasping part 650 and the adjusting part 620 are all accommodated in the distal end of the delivery device 200, and the delivery device 200 is sent into the left ventricle through the transapical approach and then crosses the mitral valve orifice to reach Left atrium, retract the delivery device 200, so that the adjustment part 620 and the grasping part 650 gradually protrude from the delivery device 200 and are deployed in the left atrium; continue to withdraw the delivery device 200 until the clamping part 630 also protrudes from the delivery device 200 and unfolded in the left ventricle; then the clamping part 630 is pushed to the far end by the driving part, and the anterior leaflet and the posterior leaflet of the mitral valve are respectively supported on the inner surfaces of the two forceps arms 631 of the clamping part 630, and the proximal The end retracts the grasping part 650 and the adjusting part 620, that is, drives the grasping part 650 to move in the direction of the clamping part 630, thereby capturing the leaflet between the grasping part 650 and the clamping part 630, and then drives the clamping part 630 The joint part 630 is closed relative to the adjustment part 620 and the support part 610, so that the front leaf and the rear leaf are respectively fixed between a pincer arm 631 and a grasping arm 651 corresponding to the pincer arm 631, and then pushed to the distal end The delivery device 200 is until the valve clamping device 600 is gradually closed; the connection between the valve clamping device and the delivery device 200 is released, so that the valve clamping device is implanted on the mitral valve, and the anterior leaflet of the mitral valve and the The posterior lobes are drawn towards each other forming a bipodous structure.

可以理解的是,依据本申请的瓣膜夹合系统包括上述的任一瓣膜夹合装置以及能够将该瓣膜夹合装置从体外输送至二尖瓣附近并夹合瓣叶的输送装置。以上关于瓣膜夹合装置的阐述仅用作举例,并不是对本申请的限制,本领域的普通技术人员基于本申请的教导获得的瓣膜夹合装置以及包含该瓣膜夹合装置的瓣膜夹合系统均在本申请的保护范围内。It can be understood that the valve clamping system according to the present application includes any valve clamping device mentioned above and a delivery device capable of delivering the valve clamping device from outside the body to the vicinity of the mitral valve and clamping the leaflets. The above description about the valve clamping device is only used as an example, and is not a limitation to the present application. The valve clamping device obtained by those of ordinary skill in the art based on the teaching of the application and the valve clamping system comprising the valve clamping device are all Within the protection scope of this application.

需要说明的是,在本文中,诸如“第一”和“第二”等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来,而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且,术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素,而且还包括没有明确列出的其他要素,或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下,由语句“包括一个……”限定的要素,并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。It should be noted that in this article, relative terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply these No such actual relationship or order exists between entities or operations. Furthermore, the term "comprises", "comprises" or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus comprising a set of elements includes not only those elements, but also includes elements not expressly listed. other elements of or also include elements inherent in such a process, method, article, or device. Without further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article or apparatus comprising said element.

以上所述仅是本发明的具体实施方式,使本领域技术人员能够理解或实现本发明。对这些实施例的多种修改对本领域的技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所申请的原理和新颖特点相一致的最宽的范围。The above descriptions are only specific embodiments of the present invention, so that those skilled in the art can understand or implement the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Accordingly, the present invention will not be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims (19)

1.一种瓣膜夹合装置,其特征在于,包括:1. A valve clamping device, characterized in that, comprising: 支撑部,所述支撑部包括相对设置的连接端和自由端;a support portion, the support portion includes a connecting end and a free end disposed opposite to each other; 中空的调节部,所述支撑部的至少一部分设于所述调节部内,所述调节部的一端套设在所述连接端外侧并与所述支撑部连接,所述支撑部的自由端位于所述调节部内,并且所述自由端用于与输送装置可拆卸连接,所述调节部的另一端自由悬空;A hollow adjustment part, at least a part of the support part is set in the adjustment part, one end of the adjustment part is sleeved outside the connection end and connected with the support part, and the free end of the support part is located at the inside the regulating part, and the free end is used for detachable connection with the conveying device, and the other end of the regulating part is freely suspended; 夹合部,所述夹合部围设于所述调节部的外侧;A clamping part, the clamping part is surrounded by the outer side of the adjustment part; 驱动部,所述驱动部与所述夹合部连接,以驱动所述夹合部围绕所述调节部展开或闭合。A driving part, the driving part is connected with the clamping part to drive the clamping part to expand or close around the adjusting part. 2.根据权利要求1所述的瓣膜夹合装置,其特征在于,所述调节部包括弹性主体,所述弹性主体的一端与所述支撑部连接,所述弹性主体的另一端具有开口并自由悬空。2. The valve clamping device according to claim 1, wherein the adjustment part comprises an elastic body, one end of the elastic body is connected to the support part, and the other end of the elastic body has an opening and is free. dangling. 3.根据权利要求2所述的瓣膜夹合装置,其特征在于,所述开口的尺寸小于或者等于所述自由端的尺寸。3. The valve clamping device according to claim 2, wherein the size of the opening is smaller than or equal to the size of the free end. 4.根据权利要求2所述的瓣膜夹合装置,其特征在于,所述弹性主体的近端边缘套设一中空的圈套结构形成所述开口。4 . The valve clamping device according to claim 2 , wherein a hollow snare structure is sheathed on the proximal edge of the elastic body to form the opening. 5.根据权利要求2所述的瓣膜夹合装置,其特征在于,所述弹性主体的近端边缘围合形成所述开口。5 . The valve clamping device according to claim 2 , wherein the proximal edge of the elastic body encloses the opening. 6 . 6.根据权利要求2所述的瓣膜夹合装置,其特征在于,所述弹性主体选自网状结构、框架结构、致密结构或多孔结构中的至少一种。6 . The valve clamping device according to claim 2 , wherein the elastic body is at least one selected from a network structure, a frame structure, a dense structure or a porous structure. 7.根据权利要求6所述的瓣膜夹合装置,其特征在于,当所述弹性主体为所述网状结构或框架结构时,所述弹性主体的至少部分外表面施加覆膜。7. The valve clipping device according to claim 6, wherein when the elastic body is the mesh structure or the frame structure, at least part of the outer surface of the elastic body is covered with a film. 8.根据权利要求6所述的瓣膜夹合装置,其特征在于,当所述弹性主体为所述网状结构或框架结构时,所述弹性主体由形状记忆材料经编织或切割而成。8. The valve clipping device according to claim 6, wherein when the elastic body is the mesh structure or the frame structure, the elastic body is woven or cut from a shape memory material. 9.根据权利要求8所述的瓣膜夹合装置,其特征在于,当所述弹性主体为所述网状结构时,所述网状结构的网丝在近端弯折绕回形成所述近端边缘。9. The valve clamping device according to claim 8, characterized in that, when the elastic body is the mesh structure, the mesh wires of the mesh structure are bent back at the proximal end to form the proximal end edge. 10.根据权利要求8所述的瓣膜夹合装置,其特征在于,当所述弹性主体为所述框架结构时,所述框架结构的相邻支杆之间彼此间隔或者交联,所述框架结构的支杆在近端聚拢形成所述近端边缘。10. The valve clamping device according to claim 8, wherein when the elastic body is the frame structure, the adjacent struts of the frame structure are spaced from each other or cross-linked, and the frame The struts of the structure converge at the proximal end to form the proximal edge. 11.根据权利要求8所述的瓣膜夹合装置,其特征在于,当所述弹性主体为所述致密结构时,所述致密结构为硅胶体;当所述弹性主体为所述多孔结构时,所述多孔结构为海绵体;所述致密结构或多孔结构的近端边缘形成所述开口。11. The valve clamping device according to claim 8, characterized in that, when the elastic body is the dense structure, the dense structure is silicon colloid; when the elastic body is the porous structure, The porous structure is a sponge; the dense structure or the proximal edge of the porous structure forms the opening. 12.根据权利要求2所述的瓣膜夹合装置,其特征在于,所述弹性主体的远端固定套设于所述支撑部上,或者所述弹性主体的远端边缘外部套设一中空的圈套结构,所述圈套结构固定套设于所述支撑部上。12. The valve clamping device according to claim 2, characterized in that, the distal end of the elastic body is fixedly sleeved on the support part, or the distal edge of the elastic body is sleeved with a hollow A snare structure, the snare structure is fixedly sleeved on the support part. 13.根据权利要求1所述的瓣膜夹合装置,其特征在于,所述夹合部包括至少两个钳臂,所述至少两个钳臂相对于所述调节部对称设置,所述驱动部分别与每个所述钳臂连接,以驱动每个所述钳臂围绕所述调节部转动。13. The valve clamping device according to claim 1, wherein the clamping part comprises at least two forceps arms, and the at least two forceps arms are arranged symmetrically with respect to the adjusting part, and the driving part respectively connected with each of the pliers arms to drive each of the pliers arms to rotate around the adjustment portion. 14.根据权利要求13所述的瓣膜夹合装置,其特征在于,所述调节部包括多个第一曲面和多个第二曲面,所述第一曲面与所述第二曲面彼此相邻,相对设置的两个所述第一曲面分别面向一个所述钳臂,所述第二曲面的面积大于所述第一曲面的面积。14. The valve clamping device according to claim 13, wherein the adjusting part comprises a plurality of first curved surfaces and a plurality of second curved surfaces, the first curved surfaces and the second curved surfaces are adjacent to each other, The two first curved surfaces opposite to each other face one of the pliers arms, and the area of the second curved surface is larger than that of the first curved surface. 15.根据权利要求1至13任一项所述的瓣膜夹合装置,其特征在于,所述瓣膜夹合装置还包括抓持部,所述抓持部设于所述夹合部及所述调节部之间并可相对所述调节部展开或闭合,所述抓持部及所述夹合部均展开时,所述抓持部至少部分容置于所述夹合部的内表面。15. The valve clamping device according to any one of claims 1 to 13, characterized in that, the valve clamping device further comprises a grasping part, and the grasping part is arranged on the clamping part and the clamping part. The adjustment parts can be opened or closed relative to the adjustment part. When both the gripping part and the clamping part are unfolded, the gripping part is at least partially accommodated on the inner surface of the clamping part. 16.根据权利要求1至13任一项所述的瓣膜夹合装置,其特征在于,所述瓣膜夹合装置还包括与所述支撑部固定连接的基座,所述夹合部转动连接于所述基座上。16. The valve clamping device according to any one of claims 1 to 13, characterized in that, the valve clamping device further comprises a base fixedly connected to the support part, and the clamping part is rotatably connected to on the base. 17.根据权利要求16所述的瓣膜夹合装置,其特征在于,所述驱动部包括:驱动轴、连接座以及至少两个连杆;其中,每个所述连杆的一端与夹合部连接,另一端与所述连接座枢接;所述驱动轴的一端与所述连接座连接,另一端活动地穿装在所述基座中。17. The valve clamping device according to claim 16, wherein the driving part comprises: a driving shaft, a connecting seat and at least two connecting rods; wherein, one end of each connecting rod is connected to the clamping part The other end is pivotally connected to the connecting seat; one end of the drive shaft is connected to the connecting seat, and the other end is movably worn in the base. 18.根据权利要求17所述的瓣膜夹合装置,其特征在于,所述瓣膜夹合装置还包括设于所述基座中的锁定部,所述锁定部限制所述驱动轴与所述基座的相对运动。18. The valve clamping device according to claim 17, characterized in that, the valve clamping device further comprises a locking part provided in the base, and the locking part restricts the driving shaft from the base. The relative motion of the seat. 19.一种瓣膜夹合系统,其特征在于,包括权利要求1至18任一项所述的瓣膜夹合装置、以及输送装置,所述输送装置包括:具有一定轴向长度的推送轴及活动地穿装在所述推送轴中的芯轴,所述推送轴与所述支撑部之间可拆卸连接,所述芯轴与所述驱动部相连,用于驱动所述夹合部相对于所述支撑部的展开和闭合。19. A valve clamping system, characterized in that it comprises the valve clamping device according to any one of claims 1 to 18, and a delivery device, the delivery device comprising: a push shaft with a certain axial length and a movable The mandrel installed in the push shaft is detachably connected between the push shaft and the support part, the mandrel is connected with the driving part, and is used to drive the clamping part relative to the The opening and closing of the above-mentioned supporting part.
CN202010192630.9A 2020-03-18 2020-03-18 Valve clamping device and valve clamping system Active CN111904660B (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CN202010192630.9A CN111904660B (en) 2020-03-18 2020-03-18 Valve clamping device and valve clamping system
CN202310195744.2A CN116211543A (en) 2020-03-18 2020-03-18 Valve clamping device and valve clamping system
EP21770911.2A EP4122426A4 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system
US17/906,641 US20230157819A1 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system
BR112022018791A BR112022018791A2 (en) 2020-03-18 2021-03-18 VALVE FIXING DEVICE AND VALVE FIXING SYSTEM
PCT/CN2021/081606 WO2021185324A1 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system

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