CN114681131A - Valve stitching instrument - Google Patents

Abstract

Translated fromChinese

本申请提供一种瓣膜缝合器，包括推送装置与夹持装置。推送装置包括推送导管。夹持装置包括夹持推杆、近端夹头、远端夹头、夹持操作机构及弹性机构。夹持推杆活动地穿装在推送导管中，近端夹头设于推送导管的远端，远端夹头设于夹持推杆的远端，弹性机构固定连接夹持推杆的近端，夹持操作机构活动连接夹持推杆的近端及弹性机构。夹持操作机构带动夹持推杆由远端向近端移动使远端夹头与近端夹头闭合后，夹持操作机构压缩弹性机构，使夹持操作机构相对于夹持推杆向近端发生位移以发出声音反馈，从而避免操作者为获得声音反馈强制向近端移动夹持操作机构，使得远端夹头和近端夹头过度夹紧瓣叶而夹伤瓣叶。

The present application provides a valve stapler, which includes a pushing device and a clamping device. The pusher includes a pusher catheter. The clamping device includes a clamping push rod, a proximal collet, a distal collet, a clamping operating mechanism and an elastic mechanism. The clamping push rod is movably installed in the push catheter, the proximal end chuck is arranged at the distal end of the pushing catheter, the distal end clamp is arranged at the distal end of the clamping push rod, and the elastic mechanism is fixedly connected to the proximal end of the clamping push rod , the clamping operating mechanism is movably connected to the proximal end of the clamping push rod and the elastic mechanism. After the clamping operation mechanism drives the clamping push rod to move from the distal end to the proximal end to close the distal end collet and the proximal end clamp, the clamping operation mechanism compresses the elastic mechanism, so that the clamping operation mechanism moves closer to the clamping push rod. The end is displaced to give sound feedback, so as to avoid the operator forcibly moving the clamping operating mechanism to the proximal end in order to obtain the sound feedback, so that the distal collet and the proximal collet over-clamp the valve leaflet and pinch the valve leaflet.

Description

Translated fromChinese

瓣膜缝合器valve stapler

技术领域technical field

本申请涉及医疗器械技术领域，特别涉及一种瓣膜缝合器。The present application relates to the technical field of medical devices, in particular to a valve stapler.

背景技术Background technique

二尖瓣为左心房(简称：LA)和左心室(简称：LV)之间的单向“阀门”，可以保证血液从左心房流向左心室。请参见图1，正常健康的二尖瓣具有多根腱索。二尖瓣的瓣叶分为前叶和后叶，左心室处于舒张状态时，两者处于张开状态，血液从左心房流向左心室；左心室处于收缩状态时，腱索被拉伸，保证瓣叶不会被血流冲到心房侧，前、后叶闭合良好，从而保证血液从左心室经过主动脉瓣(简称：AV)流向主动脉。若腱索或乳头肌出现病变，例如图2所示的后叶腱索断裂，当左心室处于收缩状态时，二尖瓣不能像正常状态时恢复至关闭状态，血流的冲力会进一步导致瓣叶脱入左心房，造成血液返流。The mitral valve is a one-way "valve" between the left atrium (abbreviated: LA) and the left ventricle (abbreviated: LV), which allows blood to flow from the left atrium to the left ventricle. See Figure 1, a normal healthy mitral valve has multiple chordae tendineae. The leaflets of the mitral valve are divided into anterior leaflets and posterior leaflets. When the left ventricle is in a diastolic state, the two are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contracted state, the chordae tendineae are stretched to ensure The valve leaflets will not be flushed to the atrium side by the blood flow, and the anterior and posterior leaflets are well closed, thereby ensuring that the blood flows from the left ventricle through the aortic valve (abbreviation: AV) to the aorta. If there is a disease of the chordae tendineae or papillary muscles, such as the rupture of the posterior chordae tendineae shown in Figure 2, when the left ventricle is in a contracted state, the mitral valve cannot return to a closed state like in a normal state, and the impulse of blood flow will further cause the valve The lobes protrude into the left atrium, causing reflux of blood.

目前通常采用外科手术植入缝合线的方式治疗腱索病变，需要采用侵入性开胸技术，并实行全麻、中度低温体外循环作为辅助支持。这类外科手术存在手术过程复杂、手术成本高、病人创伤程度高、并发症风险高、住院时间长以及患者恢复过程痛苦等缺陷。At present, chorda tendinopathy is usually treated by surgically implanting sutures, which requires invasive thoracotomy, general anesthesia, and moderate hypothermic cardiopulmonary bypass as auxiliary support. Such surgical procedures have disadvantages such as complex surgical procedures, high surgical costs, high degree of patient trauma, high risk of complications, long hospital stays, and painful recovery for patients.

现有一种通过微创方式植入缝合线的器械，该器械通过夹持装置夹持瓣叶来植入缝合线。夹持装置包括夹持推杆、用于配合夹持瓣叶的远端夹头和近端夹头及连接于夹持推杆近端的夹持操作机构。夹持操作机构由远端向近端移动使远端夹头和近端夹头闭合，当夹持操作机构由远端向近端移动至预定位置时发出闭合声音反馈。操作者可根据声音反馈确认远端夹头与近端夹头是否闭合。然而由于制造工艺不可避免存在公差的问题，可能出现夹持推杆长度不足的情况，导致远端夹头与近端夹头夹持瓣叶闭合时，夹持操作机构无法移动至预定位置而发出声音反馈。而操作者为了确认远端夹头与近端夹头闭合，强制向近端移动夹持操作机构，会导致远端夹头与近端夹头过度夹紧瓣叶而夹伤瓣叶。There is a device for implanting sutures in a minimally invasive manner, and the device holds the valve leaflets by a clamping device to implant the sutures. The clamping device includes a clamping push rod, a distal end clamp and a proximal clamp for cooperating with clamping the valve leaflet, and a clamping operation mechanism connected to the proximal end of the clamping push rod. The clamping operation mechanism moves from the distal end to the proximal end to close the distal end collet and the proximal end clamp, and when the clamping operation mechanism moves from the distal end to the proximal end to a predetermined position, a closing sound feedback is issued. The operator can confirm whether the distal collet and the proximal collet are closed according to the audio feedback. However, due to the unavoidable tolerance problem in the manufacturing process, the length of the clamping push rod may be insufficient, resulting in the clamping operating mechanism unable to move to the predetermined position when the distal collet and the proximal collet clamp the valve leaflet. sound feedback. However, in order to confirm the closure of the distal collet and the proximal collet, the operator forcibly moves the clamping operating mechanism to the proximal end, which may cause the distal collet and the proximal collet to over-clamp the valve leaflet and thereby pinching the valve leaflet.

发明内容SUMMARY OF THE INVENTION

为了避免出现远端夹头与近端夹头过度夹紧瓣叶而夹伤瓣叶的问题，本申请提供一种瓣膜缝合器。In order to avoid the problem that the distal collet and the proximal collet clamp the valve leaflet excessively, the present application provides a valve stapler.

为了实现上述目的，本申请实施方式采用如下技术方案：In order to achieve the above purpose, the embodiments of the present application adopt the following technical solutions:

本申请提供一种瓣膜缝合器，包括推送装置与夹持装置。所述推送装置包括推送导管；所述夹持装置包括夹持推杆、近端夹头、远端夹头、夹持操作机构及弹性机构，所述夹持推杆活动地穿装在所述推送导管中，所述近端夹头设于所述推送导管的远端，所述远端夹头设于所述夹持推杆的远端，所述弹性机构固定连接所述夹持推杆的近端，所述夹持操作机构活动连接所述夹持推杆的近端及所述弹性机构，所述夹持操作机构带动所述夹持推杆由远端向近端移动使所述远端夹头与所述近端夹头闭合后，所述夹持操作机构压缩所述弹性机构，使所述夹持操作机构相对于所述夹持推杆向近端发生位移以发出声音反馈。The present application provides a valve stapler, which includes a pushing device and a clamping device. The pushing device includes a pushing catheter; the clamping device includes a clamping push rod, a proximal end collet, a distal end clamp, a clamping operating mechanism and an elastic mechanism, and the clamping push rod is movably worn on the In the push catheter, the proximal collet is arranged at the distal end of the push catheter, the distal end collet is arranged at the distal end of the clamping push rod, and the elastic mechanism is fixedly connected to the clamping push rod The proximal end of the clamping push rod and the elastic mechanism are movably connected by the clamping operation mechanism, and the clamping operation mechanism drives the clamping push rod to move from the distal end to the proximal end to make the clamping push rod move from the distal end to the proximal end. After the distal collet and the proximal collet are closed, the clamping operation mechanism compresses the elastic mechanism, so that the clamping operation mechanism is displaced towards the proximal end relative to the clamping push rod to give sound feedback .

本申请提供的瓣膜缝合器，由于设有弹性机构，当夹持推杆长度不足以使夹持操作机构由远端向近端移动至预定位置发出声音反馈时，弹性机构可被压缩使得夹持操作机构相对于夹持推杆向近端位移而到达预定位置发出声音反馈，从而避免操作者为获得声音反馈强制向近端移动夹持操作机构，使得远端夹头和近端夹头过度夹紧瓣叶而夹伤瓣叶，提高了手术的安全性及可靠性。The valve stapler provided by the present application is provided with an elastic mechanism. When the length of the clamping push rod is not enough to make the clamping operation mechanism move from the distal end to the proximal end to a predetermined position to give sound feedback, the elastic mechanism can be compressed so that the clamping mechanism can be clamped. The operating mechanism moves towards the proximal end relative to the clamping push rod and reaches a predetermined position to give sound feedback, so as to prevent the operator from forcibly moving the clamping operation mechanism to the proximal end in order to obtain the sound feedback, so that the distal collet and the proximal collet are excessively clamped The valve leaflet is tightened and the valve leaflet is pinched, which improves the safety and reliability of the operation.

附图说明Description of drawings

图1为人体心脏在正常健康情况下的结构示意图；Figure 1 is a schematic diagram of the structure of the human heart under normal health conditions;

图2为人体心脏在后叶腱索断裂情况下的结构示意图；Figure 2 is a schematic structural diagram of a human heart under the condition of posterior chordae tendineae rupture;

图3为本申请一实施方式提供的瓣膜缝合器的立体示意图；3 is a schematic perspective view of a valve stapler provided by an embodiment of the application;

图4为图3所示的瓣膜缝合器的分解示意图；Figure 4 is an exploded schematic view of the valve stapler shown in Figure 3;

图5为本申请一实施方式提供的缝合线的立体示意图；5 is a schematic perspective view of a suture provided by an embodiment of the present application;

图6a为本申请一实施方式提供的瓣膜缝合器的探针部分伸出推送导管的立体示意图；6a is a schematic perspective view of a probe part of a valve stapler extending out of a pushing catheter according to an embodiment of the application;

图6b为图6a的局部区域I的放大示意图；Fig. 6b is the enlarged schematic diagram of the partial area I of Fig. 6a;

图7a为本申请一实施方式提供的瓣膜缝合器的探针完全位于推送导管中的立体示意图；7a is a schematic perspective view of the probe of the valve stapler provided by an embodiment of the application completely located in the push catheter;

图7b为图7a的局部区域II的放大示意图；Fig. 7b is an enlarged schematic view of partial area II of Fig. 7a;

图8为图6a所示的瓣膜缝合器的分解示意图；Figure 8 is an exploded schematic view of the valve stapler shown in Figure 6a;

图9为图7a所示的瓣膜缝合器的分解示意图；Figure 9 is an exploded schematic view of the valve stapler shown in Figure 7a;

图10为本申请一实施方式提供的推送手柄的分解示意图；10 is an exploded schematic view of a push handle provided by an embodiment of the application;

图11为本申请一实施方式提供的夹持装置的夹持操作机构的立体示意图；11 is a schematic perspective view of a clamping operating mechanism of a clamping device provided by an embodiment of the application;

图12为本申请一实施方式提供的夹持装置的夹持操作机构的分解示意图；12 is an exploded schematic view of a clamping operating mechanism of a clamping device provided by an embodiment of the application;

图13为本申请一实施方式提供的穿刺手柄与保险件处于锁定状态的示意图；13 is a schematic diagram of a puncture handle and a safety member in a locked state according to an embodiment of the application;

图14为本申请一实施方式提供的穿刺手柄与保险件处于解锁状态的示意图；Fig. 14 is a schematic diagram of the puncture handle and the safety element in an unlocked state provided by an embodiment of the application;

图15为本申请一实施方式提供的穿刺装置与保险件的立体示意图；15 is a schematic perspective view of a puncture device and a safety piece provided by an embodiment of the application;

图16为本申请一实施方式提供的穿刺手柄与保险件处于解锁状态的另一示意图；Fig. 16 is another schematic diagram of the puncture handle and the safety element in an unlocked state provided by an embodiment of the application;

图17为本申请一实施方式提供的保险件的立体示意图；FIG. 17 is a schematic three-dimensional schematic diagram of a fuse provided by an embodiment of the application;

图18为本申请一实施方式提供的夹持辅助装置的立体示意图；FIG. 18 is a schematic perspective view of a clamping auxiliary device provided by an embodiment of the application;

图19为本申请一实施方式提供的夹持辅助装置的辅助操纵机构的立体示意图；19 is a schematic perspective view of an auxiliary manipulation mechanism of a clamping auxiliary device provided by an embodiment of the application;

图20为本申请一实施方式提供的夹持辅助件配合夹持装置夹持瓣叶的示意图；Fig. 20 is a schematic diagram of a clamping aid provided by an embodiment of the application in cooperation with a clamping device to clamp a valve leaflet;

图21为本申请一实施方式提供的推送导管的剖视图；21 is a cross-sectional view of a push catheter provided by an embodiment of the application;

图22-图33为本申请一实施方式提供的瓣膜缝合器将缝合线植入瓣叶的实施过程示意图。22-33 are schematic diagrams of the implementation process of implanting sutures into valve leaflets by the valve stapler according to an embodiment of the application.

具体实施方式Detailed ways

为了使本申请的目的、技术方案和优点更加清楚，下面将结合附图对本申请作进一步地详细描述。In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below with reference to the accompanying drawings.

应当理解的是，可以在本申请中使用的诸如“包括”以及“可以包括”之类的表述表示所公开的功能、操作或构成要素的存在性，并且并不限制一个或多个附加功能、操作和构成要素。在本公开中，诸如“包括”和/或“具有”之类的术语可解释为表示特定特性、数目、操作、构成要素、组件或它们的组合，但是不可解释为将一个或多个其它特性、数目、操作、构成要素、组件或它们的组合的存在性或添加可能性排除在外。It should be understood that expressions such as "comprising" and "may include" that may be used in this application denote the presence of a disclosed function, operation, or element and do not limit one or more additional functions, Operations and Components. In this disclosure, terms such as "comprising" and/or "having" may be construed to mean a particular characteristic, number, operation, constituent element, component, or combination thereof, but not to mean one or more other characteristics , number, operation, constituent elements, components or the presence or possibility of addition of their combinations are excluded.

此外，在本申请中，表述“和/或”包括关联列出的词语中的任意和所有组合。例如，表述“A和/或B”可以包括A，可以包括B，或者可以包括A和B这二者。Furthermore, in this application, the expression "and/or" includes any and all combinations of the associated listed words. For example, the expression "A and/or B" may include A, may include B, or may include both A and B.

在本申请中，包含诸如“第一”和“第二”等的序数在内的表述可以修饰各要素。然而，这种要素不被上述表述限制。例如，上述表述并不限制要素的顺序和/或重要性。上述表述仅用于将一个要素与其它要素进行区分。在不脱离本公开的范围的情况下，第一要素可以被称为第二要素，类似地，第二要素也可以被称为第一要素。In this application, expressions including ordinal numbers such as "first" and "second" may modify various elements. However, such elements are not limited by the above expression. For example, the above expressions do not limit the order and/or importance of the elements. The above expressions are only used to distinguish one element from another. A first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of the present disclosure.

当组件被称作“连接”或“接入”其他组件时，应当理解的是：该组件不仅可以直接连接到或接入到其他组件，而且在该组件和其它组件之间还可以存在另一组件。另一方面，当组件被称作“直接连接”或“直接接入”其他组件的情况下，应该理解它们之间不存在组件。When a component is referred to as being "connected" or "connected to" other components, it should be understood that not only can the component be directly connected or connected to the other component, but another component may exist between the component and the other component. components. On the other hand, when components are referred to as being "directly connected" or "directly connected" to other components, it should be understood that there are no components between them.

在介入医疗器械技术领域，一般将靠近操作者的方位定义为近端，远离操作者的方位定义为远端。将柱体、管体等一类物体的中轴线的方向定义为轴向。径向是指在径向平面内通过中轴线的方向，例如，沿直径或半径的直线方向，或垂直于中轴线的直线方向。In the technical field of interventional medical devices, the position close to the operator is generally defined as the proximal end, and the position far from the operator is defined as the distal end. The direction of the central axis of objects such as cylinders and tubes is defined as the axial direction. Radial refers to a direction in a radial plane through the central axis, eg, a line along a diameter or radius, or a line perpendicular to the central axis.

请参阅图3与图4，本申请的一实施方式提供一种瓣膜缝合器100，用于将缝合线60(如图5所示)植入患者体内，替代患者心脏内病变或者断裂的腱索；或用于将多根缝合线60植入患者体内并彼此固定，实现心脏瓣膜(如二尖瓣、三尖瓣)缘对缘修复。瓣膜缝合器100包括夹持装置10、穿刺装置20、推送装置30、夹持辅助装置40及探测装置50。推送装置30用于将夹持装置10输送至瓣膜附近的预定位置。夹持装置10用于容置缝合线60及夹持瓣膜的瓣叶。夹持辅助装置40用于支撑在瓣叶下表面并与夹持装置10配合夹持瓣叶。探测装置50用于探测夹持装置10是否夹持瓣膜的瓣叶及对瓣叶的夹持效果。穿刺装置20用于在夹持装置10夹持瓣膜后穿刺瓣膜。Referring to FIGS. 3 and 4 , an embodiment of the present application provides avalve stapler 100 for implanting a suture 60 (as shown in FIG. 5 ) into a patient's body to replace the diseased or ruptured chordae tendineae in the patient's heart ; or for implanting a plurality ofsutures 60 into a patient and fixing each other to achieve edge-to-edge repair of heart valves (eg, mitral valve, tricuspid valve). Thevalve stapler 100 includes aclamping device 10 , apuncturing device 20 , a pushingdevice 30 , a clampingauxiliary device 40 and adetection device 50 . Thepusher 30 is used to deliver thegripping device 10 to a predetermined location near the valve. Thegripping device 10 is used to receive thesuture 60 and grip the leaflets of the valve. The clampingauxiliary device 40 is used to support the lower surface of the valve leaflet and cooperate with the clampingdevice 10 to clamp the valve leaflet. Thedetection device 50 is used to detect whether the clampingdevice 10 clamps the valve leaflets of the valve and the clamping effect on the valve leaflets. The puncturingdevice 20 is used to puncture the valve after the holdingdevice 10 holds the valve.

以缝合线60作为人工腱索，实现瓣膜的腱索修复为例进行详细描述。请参阅图5，缝合线60包括一段具有柔性的缝合线主体62。缝合线主体62具有相对的第一端和第二端。第一端和/或第二端连接有固定件64。固定件64用于与穿刺装置20不可拆卸固定连接或可拆卸固定连接。固定件64可以设置在缝合线主体62的两端，也可以仅设置在缝合线主体62的一端。在本实施方式中，缝合线主体62的两端均设有固定件64。缝合线60的数量可以是一根，也可以是两个或者多根。缝合线主体62的材料可以是与人体相容的高分子材料或者较为柔软的金属材料等，优选为聚对苯二甲酸乙二醇酯(polyethylene terephthalate，PET)、膨体聚四氟乙烯(expended polytetrafluoroethylene，e-PTFE)等高分子材料。本实施方式中，缝合线主体62用于植入心脏内，替代心脏内的病变腱索，即，缝合线主体62的一端固定在瓣叶上，另一端固定在心室壁上或者乳头肌等部位，以替代病变的腱索，维持瓣叶与心室壁之间的张力。Taking thesuture 60 as the artificial chordae tendineae to realize the repair of the chordae tendineae of the valve as an example, the detailed description will be given. Referring to FIG. 5 ,suture 60 includes aflexible suture body 62 .Suture body 62 has opposing first and second ends. The first end and/or the second end is connected with a fixingmember 64 . The fixingmember 64 is used for a non-removable fixed connection or a detachable fixed connection with the puncturingdevice 20 . The fixingmembers 64 may be provided on both ends of the suturemain body 62 , or may be provided only on one end of the suturemain body 62 . In this embodiment, both ends of the suturemain body 62 are provided with fixingmembers 64 . The number ofsutures 60 may be one, or two or more. The material of thesuture body 62 may be a polymer material or a relatively soft metal material that is compatible with the human body, preferably polyethylene terephthalate (PET), expanded polytetrafluoroethylene (expanded polytetrafluoroethylene) Polytetrafluoroethylene, e-PTFE) and other polymer materials. In this embodiment, thesuture body 62 is used for implantation in the heart to replace the diseased chordae tendineae in the heart, that is, one end of thesuture body 62 is fixed on the valve leaflet, and the other end is fixed on the ventricular wall or the papillary muscle and other parts , to replace the diseased chordae tendineae and maintain the tension between the valve leaflets and the ventricular wall.

请结合参阅图6a至图10，推送装置30包括推送导管32及连接于推送导管32近端的推送手柄34。推送手柄34用于操纵整个瓣膜缝合器100向远端推送或者向近端回撤。本实施方式中，推送手柄34包括第一壳体342和可拆卸盖合于第一壳体342上的第二壳体344，推送导管32为具有一定轴向长度的管状体或者具有内腔的杆状体。Please refer to FIGS. 6 a to 10 , the pushingdevice 30 includes a pushingcatheter 32 and a pushinghandle 34 connected to the proximal end of the pushingcatheter 32 . The push handle 34 is used to manipulate theentire valve stapler 100 to be pushed distally or withdrawn proximally. In this embodiment, the push handle 34 includes afirst casing 342 and asecond casing 344 detachably covered on thefirst casing 342 , and thepush conduit 32 is a tubular body with a certain axial length or a tube with an inner cavity. rod-shaped body.

请参阅图6a至图7b，夹持装置10包括容置有缝合线60的夹持推杆12及用于配合夹持瓣叶的远端夹头14和近端夹头16。远端夹头14设于夹持推杆12的远端，近端夹头16设于推送导管32的远端。夹持推杆12活动地穿装在推送手柄34的内腔及推送导管32中。Referring to Figures 6a-7b, the clampingdevice 10 includes aclamping pusher 12 that accommodates asuture 60, and adistal collet 14 and aproximal collet 16 for cooperating to clamp the valve leaflets. Thedistal collet 14 is disposed at the distal end of the clampingpush rod 12 , and theproximal collet 16 is disposed at the distal end of the pushingcatheter 32 . The clampingpush rod 12 is movably inserted into the inner cavity of the push handle 34 and thepush conduit 32 .

夹持推杆12为具有一定轴向长度的管状体或中空杆状体，横截面优选为椭圆形或者圆形，且夹持推杆12中沿轴向设有缝合线通道122(如图4所示)。远端夹头14中设有与缝合线通道122相连通的两个缝合线收容腔142(如图7b所示)，两个缝合线收容腔142分别贯通至远端夹头14的夹持面。缝合线60的缝合线主体62收容于缝合线通道122及缝合线收容腔142中。远端夹头14的夹持面还开设有分别用于容置缝合线60的两个固定件64的两个固定腔144(如图7b所示)。每个固定腔144分别与一个缝合线收容腔142轴向连通。The clampingpush rod 12 is a tubular body or a hollow rod-shaped body with a certain axial length, the cross section is preferably oval or circular, and the clampingpush rod 12 is provided with asuture channel 122 in the axial direction (as shown in FIG. 4 ). shown). Thedistal collet 14 is provided with two suture thread accommodating cavities 142 (as shown in FIG. 7 b ) communicating with thesuture thread channel 122 , and the two suturethread accommodating cavities 142 respectively pass through to the clamping surface of thedistal collet 14 . The suturemain body 62 of thesuture 60 is accommodated in thesuture channel 122 and thesuture receiving cavity 142 . The clamping surface of thedistal collet 14 is further provided with two fixingcavities 144 for accommodating the two fixingmembers 64 of thesuture 60 respectively (as shown in FIG. 7b ). Each fixingcavity 144 is in axial communication with asuture receiving cavity 142 respectively.

请参阅图4、图11与图12，夹持装置10还包括连接于夹持推杆12近端的夹持操作机构18及弹性机构19。夹持操作机构18设于推送手柄34。夹持操作机构18用于驱动远端夹头14与近端夹头16闭合或分离。本实施方式中，近端夹头16与远端夹头14的形状与推送导管32的形状配合一致，远端夹头14和近端夹头16在闭合后形成外表光滑的整体，以便于推送并减轻对患者伤口的损伤。Please refer to FIGS. 4 , 11 and 12 , the clampingdevice 10 further includes aclamping operation mechanism 18 and anelastic mechanism 19 connected to the proximal end of the clampingpush rod 12 . The clampingoperation mechanism 18 is provided on the push handle 34 . Theclamp operating mechanism 18 is used to drive thedistal collet 14 to close or disengage theproximal collet 16 . In this embodiment, the shapes of theproximal collet 16 and thedistal collet 14 are consistent with the shape of the pushingcatheter 32, and thedistal collet 14 and theproximal collet 16 form a smooth whole after being closed, so as to facilitate pushing And reduce the damage to the patient's wound.

夹持推杆12的近端自推送导管32的近端伸出，弹性机构19固定连接夹持推杆12的近端，夹持操作机构18活动连接夹持推杆12的近端及弹性机构19。夹持操作机构18带动夹持推杆12由远端向近端移动使远端夹头14与近端夹头16闭合后，夹持操作机构18压缩弹性机构19，使夹持操作机构18相对于夹持推杆12向近端发生位移以发出声音反馈。The proximal end of the clampingpush rod 12 protrudes from the proximal end of the pushingcatheter 32 , theelastic mechanism 19 is fixedly connected to the proximal end of the clampingpush rod 12 , and theclamping operation mechanism 18 is movably connected to the proximal end of the clampingpush rod 12 and theelastic mechanism 19. After theclamping operation mechanism 18 drives the clampingpush rod 12 to move from the distal end to the proximal end to close thedistal collet 14 and theproximal collet 16 , the clampingoperation mechanism 18 compresses theelastic mechanism 19 so that the clampingoperation mechanism 18 is opposite to each other. The clampingpush rod 12 is displaced towards the proximal end to give sound feedback.

由于瓣膜缝合器100设有弹性机构19，当夹持推杆12长度不足以使夹持操作机构18由远端向近端移动至预定位置发出声音反馈时，弹性机构19可被压缩使得夹持操作机构18相对于夹持推杆12向近端位移而到达预定位置发出声音反馈，从而避免操作者为获得声音反馈强制向近端移动夹持操作机构18，使得远端夹头14和近端夹头16过度夹紧瓣叶而夹伤瓣叶，如此，提高了手术的安全性及可靠性。Since thevalve stapler 100 is provided with theelastic mechanism 19, when the length of the clampingpush rod 12 is not enough to make theclamping operation mechanism 18 move from the distal end to the proximal end to the predetermined position, theelastic mechanism 19 can be compressed to make theclamping operation mechanism 18 move to the predetermined position. Theoperating mechanism 18 is displaced to the proximal end relative to the clampingpush rod 12 and reaches a predetermined position to emit sound feedback, so as to prevent the operator from forcibly moving theclamping operation mechanism 18 to the proximal end in order to obtain the sound feedback, so that thedistal collet 14 and the proximal end are forced to move. The clampinghead 16 over-clamps the valve leaflets and injures the valve leaflets, thus improving the safety and reliability of the operation.

推送手柄34的第二壳体344的内表面沿轴向设有滑移槽345(如图9与图10所示)，夹持操作机构18包括连接的滑移件182与操作组件184，滑移件182滑动设于滑移槽345中。滑移槽345用于对滑移件182的移动进行导向并限位。弹性机构19与滑移件182活动连接，弹性机构19与夹持推杆12的近端固定连接。夹持推杆12的近端抵持滑移件182。操作组件184用于驱动滑移件182沿滑移槽345轴向滑动。具体地，滑移件182开设有一推杆安装孔1822，夹持推杆12的近端收容于推杆安装孔1822内而抵持滑移件182，弹性机构19部分收容于推杆安装孔1822内并与夹持推杆12的近端固定连接。如此，弹性机构19和夹持推杆12部分穿设于滑移件182的推杆安装孔1822中而连接，夹持推杆12的近端抵持滑移件182而保持在推杆安装孔1822中，滑移件182可压缩弹性机构19而使夹持操作机构18相对于夹持推杆12向近端位移而到达预定位置发出声音反馈。The inner surface of thesecond housing 344 of the push handle 34 is provided with a slidinggroove 345 in the axial direction (as shown in FIG. 9 and FIG. 10 ). The movingpiece 182 is slidably disposed in the slidinggroove 345 . The slidinggroove 345 is used to guide and limit the movement of the slidingmember 182 . Theelastic mechanism 19 is movably connected with the slidingmember 182 , and theelastic mechanism 19 is fixedly connected with the proximal end of the clampingpush rod 12 . The proximal end of the clampingpush rod 12 abuts against the slidingmember 182 . The operatingassembly 184 is used to drive the slidingmember 182 to slide axially along the slidinggroove 345 . Specifically, the slidingmember 182 defines a pushrod installation hole 1822 , the proximal end of the clampingpush rod 12 is accommodated in the pushrod installation hole 1822 to abut the slidingmember 182 , and theelastic mechanism 19 is partially accommodated in the pushrod installation hole 1822 inside and fixedly connected with the proximal end of the clampingpush rod 12 . In this way, theelastic mechanism 19 and the clampingpush rod 12 are partially penetrated through the pushrod installation hole 1822 of the slidingmember 182 to be connected, and the proximal end of the clampingpush rod 12 abuts the slidingmember 182 and is held in the push rod installation hole In 1822, the slidingmember 182 can compress theelastic mechanism 19 so that the clampingoperating mechanism 18 is displaced proximally relative to the clampingpush rod 12 and reaches a predetermined position to emit sound feedback.

进一步地，操作组件184与滑移件182弹性连接，推送手柄34的内表面还设有导向槽347，操作组件184滑动设于导向槽347(如图10所示)中。导向槽347包括相连的径向导向槽3471及轴向导向槽3473，轴向导向槽3473相较于径向导向槽3471更靠近推送手柄34的中轴线。导向槽347大致为L形槽状结构，径向导向槽3471连通于轴向导向槽3473的近端。操作组件184可在自然状态与压缩状态之间转换，操作组件184由轴向导向槽3471移动到径向导向槽3473时，操作组件184由压缩状态转换为自然状态而冲击推送手柄34以产生声音反馈。Further, theoperation assembly 184 is elastically connected with the slidingmember 182 , the inner surface of the push handle 34 is further provided with aguide groove 347 , and theoperation assembly 184 is slidably disposed in the guide groove 347 (as shown in FIG. 10 ). Theguide groove 347 includes a connectedradial guide groove 3471 and anaxial guide groove 3473 . Theaxial guide groove 3473 is closer to the central axis of the push handle 34 than theradial guide groove 3471 . Theguide groove 347 is substantially an L-shaped groove structure, and theradial guide groove 3471 communicates with the proximal end of theaxial guide groove 3473 . The operating assembly 184 can be converted between the natural state and the compressed state. When the operating assembly 184 moves from theaxial guide groove 3471 to theradial guide groove 3473, the operatingassembly 184 is converted from the compressed state to the natural state, and pushes thehandle 34 to generate sound. feedback.

为方便操作，滑移件182的两侧均连接有操作组件184。推送手柄34的侧面还设有操作通槽348(如图9与图10所示)。操作组件184包括滑动板1841、操作件1843及弹性件1845。滑动板1841连接操作件1843，滑动板1841滑动设于导向槽347中，操作件1843卡设于操作通槽348并露出推送手柄34外。操作通槽348起到限制夹持操作机构18的轴向移动距离的作用。通过操作操作件1843在操作通槽348移动带动滑移件182移动，从而控制远端夹头14与近端夹头16的开合。弹性件1845连接于滑移件182与滑动板1841之间，在弹性件1845由压缩状态转换为自然状态时，操作件1843冲击推送手柄34以产生声音反馈，方便操作者确认远端夹头14与近端夹头16闭合夹持住瓣叶。For the convenience of operation, both sides of the slidingmember 182 are connected with operatingcomponents 184 . The side of the push handle 34 is also provided with an operation through slot 348 (as shown in FIG. 9 and FIG. 10 ). The operatingassembly 184 includes a slidingplate 1841 , an operatingmember 1843 and anelastic member 1845 . The slidingplate 1841 is connected to the operatingmember 1843 , the slidingplate 1841 is slidably disposed in theguide groove 347 , and the operatingmember 1843 is clamped in the operating throughgroove 348 and exposed to the outside of the push handle 34 . The operation throughgroove 348 functions to limit the axial movement distance of theclamping operation mechanism 18 . The movement of the operatingmember 1843 in the operating throughslot 348 drives the slidingmember 182 to move, thereby controlling the opening and closing of thedistal collet 14 and theproximal collet 16 . Theelastic member 1845 is connected between the slidingmember 182 and the slidingplate 1841. When theelastic member 1845 is converted from the compressed state to the natural state, the operatingmember 1843 impacts the push handle 34 to generate sound feedback, which is convenient for the operator to confirm thedistal end chuck 14 Close withproximal collet 16 to hold the leaflet.

夹持操作机构18还包括安装杆186，安装杆186连接于滑移件182和操作件1843之间。具体地，滑移件182沿径向的两侧设有安装杆186，操作件1841与安装杆186连接。弹性件1845套设于安装杆186外并设于滑移件182与操作件1843之间。在图示的示例中，滑动板1841与操作件1843为一体，即安装杆186也连接于滑移件182和滑动板1841之间。The clampingoperating mechanism 18 further includes a mountingrod 186 , and the mountingrod 186 is connected between the slidingmember 182 and the operatingmember 1843 . Specifically, two sides of the slidingmember 182 in the radial direction are provided with mountingrods 186 , and the operatingmember 1841 is connected with the mountingrods 186 . Theelastic piece 1845 is sleeved outside the mountingrod 186 and is arranged between the slidingpiece 182 and theoperating piece 1843 . In the illustrated example, the slidingplate 1841 is integrated with the operatingmember 1843 , that is, the mountingrod 186 is also connected between the slidingmember 182 and the slidingplate 1841 .

当滑动板1843位于径向导向槽3471时，远端夹头14与近端夹头16闭合；当滑动板1843位于轴向导向槽3473时，远端夹头14与近端夹头16分离。操作组件184通过弹性件1845的形变在自然状态与压缩状态之间转换。弹性件1845可为弹簧。弹性件1845由自然状态转换为压缩状态时，滑动板1843可由径向导向槽3471移动到轴向导向槽3473；弹性件1845由压缩状态转换为自然状态时，滑动板1843由轴向导向槽3471移动到径向导向槽3473，使得操作件1841冲击推送手柄34产生声音反馈，提示操作者远端夹头14与近端夹头16已经闭合。When the slidingplate 1843 is located in theradial guide groove 3471, thedistal collet 14 and theproximal collet 16 are closed; when the slidingplate 1843 is located in theaxial guide groove 3473, thedistal collet 14 and theproximal collet 16 are separated. The operatingassembly 184 is converted between the natural state and the compressed state by the deformation of theelastic member 1845 . Theelastic member 1845 can be a spring. When theelastic member 1845 is converted from the natural state to the compressed state, the slidingplate 1843 can be moved from theradial guide groove 3471 to theaxial guide groove 3473; when theelastic member 1845 is converted from the compressed state to the natural state, the slidingplate 1843 can be moved by theaxial guide groove 3471 Move to theradial guide groove 3473, so that the operatingmember 1841 impacts the push handle 34 to generate an audible feedback, prompting the operator that thedistal collet 14 and theproximal collet 16 have been closed.

操作件1843包括依次连接的操作部1846、连接部1847及反馈部1848。连接部1847穿设于操作通槽348，操作部1843位于推送手柄34外，反馈部1848收容于推送手柄34的内腔中，在弹性件1845由压缩状态转换为自然状态时，反馈部1848冲击推送手柄34的内侧面以产生声音反馈。本实施方式中，反馈部1848沿轴向延伸，反馈部1848可与推送手柄34的第二壳体344的内侧面抵接，增强夹持操作机构18的稳定性。操作部1846、连接部1847及反馈部1848可以一体成型，也可以分开独立设置，本申请对操作件1843的结构不作限定。The operatingmember 1843 includes anoperating portion 1846 , a connectingportion 1847 and afeedback portion 1848 that are connected in sequence. The connectingportion 1847 is penetrated through the operating throughgroove 348, the operatingportion 1843 is located outside the push handle 34, and thefeedback portion 1848 is accommodated in the inner cavity of the push handle 34. When theelastic member 1845 is converted from a compressed state to a natural state, thefeedback portion 1848 impacts Push on the inside of thehandle 34 to generate audible feedback. In this embodiment, thefeedback portion 1848 extends in the axial direction, and thefeedback portion 1848 can abut against the inner surface of thesecond housing 344 of the push handle 34 to enhance the stability of theclamping operation mechanism 18 . Theoperation part 1846 , theconnection part 1847 and thefeedback part 1848 can be integrally formed, or can be separately and independently provided. The present application does not limit the structure of theoperation part 1843 .

可以理解，当远端夹头14与近端夹头16闭合(如图22所示)时，滑动板1841位于径向导向槽3471中。当操作部1846被操作者按压，操作件1843压缩弹性件1845，使滑动板1841可从径向导向槽3471移动至轴向槽3473，此时控制操作件1843带动滑移件182及夹持推杆12向远端移动，使远端夹头14远离近端夹头16，形成如图23所示的张开状态，在远端夹头14与近端夹头16之间形成瓣叶容纳空间。微调瓣膜缝合器100远端使得瓣叶进入到瓣叶容纳空间(如图24所示)后，控制操作件1843向近端移动，滑动板1841可从轴向导向槽3473移动至径向导向槽3471，同时滑移件182带动夹持推杆12向近端移动，使得远端夹头14向近端夹头16靠近，形成如图20与图25所示的夹持状态。此时，瓣叶被夹持装置10夹持并固定。由于滑动板181处于轴向导向槽3473时，弹性件1845被压缩，当滑动板1841从轴向导向槽3473移动至径向导向槽3471时，弹性件1845恢复至自然状态产生弹力，使得反馈部1848冲击推送手柄34的内侧面而发出“卡”的声音反馈。当操作者或用户听到“卡”的声音，即可确定远端夹头14与近端夹头16闭合，将瓣叶夹持。It will be appreciated that when thedistal collet 14 and theproximal collet 16 are closed (as shown in FIG. 22 ), the slidingplate 1841 is located in theradial guide groove 3471 . When theoperating portion 1846 is pressed by the operator, the operatingmember 1843 compresses theelastic member 1845, so that the slidingplate 1841 can move from theradial guide groove 3471 to theaxial groove 3473. At this time, the operatingmember 1843 is controlled to drive the slidingmember 182 and the clamping pusher Therod 12 is moved distally, so that thedistal collet 14 is away from theproximal collet 16 to form an open state as shown in FIG. 23 , and a leaflet accommodation space is formed between thedistal collet 14 and theproximal collet 16 . After fine-tuning the distal end of thevalve stapler 100 so that the valve leaflet enters the valve leaflet accommodating space (as shown in FIG. 24 ), the operatingmember 1843 is controlled to move toward the proximal end, and the slidingplate 1841 can move from theaxial guide groove 3473 to theradial guide groove 3471, at the same time, the slidingmember 182 drives the clampingpush rod 12 to move to the proximal end, so that thedistal collet 14 approaches theproximal collet 16 to form the clamping state shown in FIG. 20 and FIG. 25 . At this time, the leaflets are clamped and fixed by theclamp device 10 . Since the sliding plate 181 is in theaxial guide groove 3473, theelastic member 1845 is compressed. When the slidingplate 1841 moves from theaxial guide groove 3473 to theradial guide groove 3471, theelastic member 1845 returns to its natural state to generate elastic force, so that the feedback part The 1848 hits the inner side of the push handle 34 to give a "snap" audible feedback. When the operator or user hears the sound of "click", it can be determined that thedistal collet 14 and theproximal collet 16 are closed to clamp the valve leaflets.

由于制造工艺不可避免存在公差的问题，可能出现夹持推杆12长度不够的情况，导致远端夹头14与近端夹头16夹持瓣叶闭合时，滑动板1841无法从轴向导向槽3473移动至径向导向槽3471而发出声音反馈。然而操作者需根据声音反馈来确认远端夹头14与近端夹头16是否闭合。这样，为了听到声音反馈，操作者会强制向近端移动操作件1843。本申请中，夹持推杆12与滑移件182通过弹性机构19弹性连接，利用弹性机构19被压缩提供空间使夹持推杆12在长度不够的情况下，滑动板1841能够被操作件1843带动从轴向导向槽3473移动至径向导向槽3471从而发出声音反馈，防止远端夹头14和近端夹头16过度夹紧瓣叶而夹伤瓣叶。Due to the unavoidable tolerance problem in the manufacturing process, the length of the clampingpush rod 12 may be insufficient, resulting in that when thedistal collet 14 and theproximal collet 16 clamp the leaflet to close, the slidingplate 1841 cannot slide from the axial guide groove. 3473 moves to theradial guide groove 3471 to give audible feedback. However, the operator needs to confirm whether thedistal collet 14 and theproximal collet 16 are closed according to the audio feedback. Thus, in order to hear the audible feedback, the operator will forcibly move the operatingmember 1843 proximally. In the present application, the clampingpush rod 12 and the slidingmember 182 are elastically connected through theelastic mechanism 19, and theelastic mechanism 19 is compressed to provide a space so that the slidingplate 1841 can be operated by the operatingmember 1843 when the clampingpush rod 12 is not long enough. It is driven to move from theaxial guide groove 3473 to theradial guide groove 3471 to give sound feedback to prevent thedistal collet 14 and theproximal collet 16 from over-clamping the valve leaflet and pinching the valve leaflet.

本实施方式中，弹性机构19包括第一连接件191和弹性元件193。第一连接件191与夹持操作机构18活动连接，具体与夹持操作机构18的滑移件182活动连接。第一连接件191的远端与夹持推杆12的近端固定连接。夹持推杆12的近端抵持夹持操作机构18，具体抵持夹持操作机构18的滑移件182。弹性元件193套设于第一连接件191外并位于第一连接件191的近端与夹持操作机构18之间。In this embodiment, theelastic mechanism 19 includes a first connectingmember 191 and anelastic element 193 . The first connectingmember 191 is movably connected with the clampingoperation mechanism 18 , and specifically, is movably connected with the slidingmember 182 of theclamping operation mechanism 18 . The distal end of the first connectingpiece 191 is fixedly connected with the proximal end of the clampingpush rod 12 . The proximal end of the clampingpush rod 12 abuts against the clampingoperation mechanism 18 , specifically the slidingmember 182 of theclamping operation mechanism 18 . Theelastic element 193 is sleeved outside the first connectingpiece 191 and is located between the proximal end of the first connectingpiece 191 and the clampingoperating mechanism 18 .

具体地，第一连接件191包括主体1911及设于主体1911近端的凸沿1913。主体1911活动穿设于夹持操作机构18中，具体活动穿设于夹持操作机构18的滑移件182中。主体1911的远端与夹持推杆12的近端固定连接。弹性元件193套设于主体1911外，弹性元件193位于凸沿1913与夹持操作机构18之间。其中，夹持推杆12的近端收容于推杆安装孔1822内，主体1911与弹性元件193部分收容于推杆安装孔1822内，夹持推杆12的近端与主体1911固定连接并抵持滑移件182而保持在推杆安装孔1822中。由于凸沿1913的存在，滑移件182由远端向近端移动时能够压缩弹性元件193，使得滑动板1841能够被操作件1843带动从轴向导向槽3473移动至径向导向槽3471从而发出声音反馈。Specifically, thefirst connector 191 includes amain body 1911 and a protrudingedge 1913 disposed at the proximal end of themain body 1911 . Themain body 1911 is movably penetrated in theclamping operation mechanism 18 , and specifically, themain body 1911 is movably penetrated in the slidingmember 182 of theclamping operation mechanism 18 . The distal end of themain body 1911 is fixedly connected with the proximal end of the clampingpush rod 12 . Theelastic element 193 is sleeved outside themain body 1911 , and theelastic element 193 is located between the protrudingedge 1913 and the clampingoperating mechanism 18 . The proximal end of the clampingpush rod 12 is accommodated in the pushrod installation hole 1822, themain body 1911 and theelastic element 193 are partially accommodated in the pushrod installation hole 1822, and the proximal end of the clampingpush rod 12 is fixedly connected to themain body 1911 and abuts against it. The slidingmember 182 is held in the pushrod mounting hole 1822 . Due to the existence of the protrudingedge 1913, the slidingmember 182 can compress theelastic element 193 when it moves from the distal end to the proximal end, so that the slidingplate 1841 can be driven by the operatingmember 1843 to move from theaxial guide groove 3473 to theradial guide groove 3471 so as to emit sound feedback.

进一步地，弹性机构17还包括第二连接件194，用于容置夹持推杆12的近端。第二连接件194固定连接于主体1911的远端与夹持推杆12的近端之间，即主体1911的远端与第二连接件194固定连接，夹持推杆12的近端与173第二连接件194固定连接。具体地，第一连接件191的远端、第二连接件194、夹持推杆12的近端均设有至少一个连接孔，三者可通过螺钉或铆钉等方式固定连接，在图12的示例中，通过螺钉固定连接。夹持推杆12的近端置于第二连接件194的容纳槽内，螺钉依次穿过夹持推杆12、第二连接件194、第一连接件191从而将三者固定连接。Further, the elastic mechanism 17 further includes a second connectingmember 194 for accommodating the proximal end of the clampingpush rod 12 . The second connectingpiece 194 is fixedly connected between the distal end of themain body 1911 and the proximal end of the clampingpush rod 12 , that is, the distal end of themain body 1911 is fixedly connected with the second connectingpiece 194 , and the proximal end of the clampingpush rod 12 is connected to the 173 The second connectingmember 194 is fixedly connected. Specifically, the distal end of the first connectingmember 191, the second connectingmember 194, and the proximal end of the clampingpush rod 12 are all provided with at least one connecting hole, and the three can be fixedly connected by means of screws or rivets. In the example, the connection is secured with screws. The proximal end of the clampingpush rod 12 is placed in the accommodating groove of the second connectingmember 194 , and the screws pass through the clampingpush rod 12 , the second connectingmember 194 , and the first connectingmember 191 in sequence to connect the three firmly.

在另一实施方式中，推送手柄34的内表面设有挡板(图未示)。弹性机构17包括第一连接件，第一连接件与夹持操作机构18活动连接，具体与夹持操作机构18的滑移件182活动连接。第一连接件包括弹性部和连接部。弹性部的径向尺寸大于连接部的径向尺寸，连接部与夹持推杆12的近端固定连接，夹持推杆12的近端抵持夹持操作机构18，具体抵持夹持操作机构18的滑移件182。弹性部的两端分别抵持夹持操作机构18的滑移件182和挡板。In another embodiment, the inner surface of the push handle 34 is provided with a baffle plate (not shown). The elastic mechanism 17 includes a first connecting piece, and the first connecting piece is movably connected with the clampingoperation mechanism 18 , and specifically, is movably connected with the slidingmember 182 of theclamping operation mechanism 18 . The first connecting member includes an elastic part and a connecting part. The radial dimension of the elastic portion is larger than the radial dimension of the connecting portion, the connecting portion is fixedly connected with the proximal end of the clampingpush rod 12, and the proximal end of the clampingpush rod 12 abuts the clampingoperation mechanism 18, specifically against the clampingoperation Slider 182 ofmechanism 18 . Both ends of the elastic portion abut against the slidingmember 182 of the clampingoperating mechanism 18 and the baffle plate respectively.

具体地，夹持推杆12的近端收容于推杆安装孔1822内，第一连接件的连接部收容于推杆安装孔1822内，夹持推杆12的近端与连接部固定连接并抵持滑移件182而保持在推杆安装孔1822中。第一连接件的弹性部位于推杆安装孔1822外并抵持滑移件182。由于挡板的存在，滑移件182由远端向近端移动时能够压缩第一连接件的弹性部，使得滑动板1841能够被操作件1843带动从轴向导向槽3473移动至径向导向槽3471从而发出声音反馈。Specifically, the proximal end of the clampingpush rod 12 is accommodated in the pushrod installation hole 1822, the connecting portion of the first connecting piece is accommodated in the pushrod installation hole 1822, and the proximal end of the clampingpush rod 12 is fixedly connected to the connecting portion and is It is held in the pushrod mounting hole 1822 against the slidingmember 182 . The elastic portion of the first connecting member is located outside the pushrod mounting hole 1822 and abuts against the slidingmember 182 . Due to the existence of the baffle, the slidingmember 182 can compress the elastic part of the first connecting member when moving from the distal end to the proximal end, so that the slidingplate 1841 can be driven by the operatingmember 1843 to move from theaxial guide groove 3473 to the radial guide groove The 3471 thus gives audible feedback.

请再次参阅图4、图9、图13-图16，穿刺装置20沿推送手柄34的轴向贯穿推送手柄34的内腔并活动地穿装在推送导管32中。穿刺装置20包括穿刺推杆22及设于穿刺推杆22远端的穿刺针头24。Referring again to FIGS. 4 , 9 , and 13-16 , thepuncture device 20 penetrates the inner cavity of the push handle 34 along the axial direction of the push handle 34 and is movably inserted into thepush catheter 32 . Thepuncture device 20 includes apuncture push rod 22 and apuncture needle 24 disposed at the distal end of thepuncture push rod 22 .

本实施方式中，远端夹头14的夹持面所开设的两个固定腔144的位置与两个穿刺针头24的位置分别对应。由此，缝合线60的两个固定件64分别容置在远端夹头14中，且每个固定件64的近端分别对应于一个穿刺针头24。穿刺针头24在穿刺瓣叶后可与缝合线60的固定件64连接，以将缝合线主体62拉向近端。穿刺针头24与固定件64形成可拆卸固定连接或不可拆卸固定连接，例如，螺纹连接、粘接、通过粗糙面摩擦连接、过盈配合或者卡扣连接。固定件64的形状配合不同的连接方式，具体地，固定件64的外部通常为柱形，横截面形状可以是圆形、椭圆形、多边形等各种形状，优选圆形或椭圆形；固定件64的内表面设有凹槽或孔，穿刺针头24的远端设有用于与固定件64形成过盈配合或者卡扣连接的至少一个凸齿或至少一圈凸沿。在图示的示例中，固定件64为圆柱形，内表面径向设有三个凹槽，与穿刺针头24上的凸齿或凸沿之间配合卡接。In this embodiment, the positions of the two fixingcavities 144 opened on the clamping surface of thedistal collet 14 correspond to the positions of the two puncture needles 24 respectively. Thus, the two fixingpieces 64 of thesuture 60 are respectively accommodated in thedistal collet 14 , and the proximal end of each fixingpiece 64 corresponds to onepuncture needle 24 , respectively. Thepuncture needle 24 can be connected to thefastener 64 of thesuture 60 after puncturing the leaflets to draw thesuture body 62 proximally. Thepuncture needle 24 and the fixingmember 64 form a detachable fixed connection or a non-detachable fixed connection, for example, a screw connection, an adhesive connection, a friction connection through a rough surface, an interference fit or a snap connection. The shape of the fixingmember 64 matches with different connection methods. Specifically, the outer portion of the fixingmember 64 is usually cylindrical, and the cross-sectional shape can be various shapes such as circle, ellipse, polygon, etc., preferably a circle or an ellipse; the fixing member The inner surface of 64 is provided with grooves or holes, and the distal end of thepuncture needle 24 is provided with at least one protruding tooth or at least one ring of protruding edges for forming an interference fit or snap connection with the fixingmember 64 . In the illustrated example, the fixingmember 64 is cylindrical, and the inner surface is radially provided with three grooves, which are engaged with the protruding teeth or protruding edges on thepuncture needle 24 .

穿刺装置20还包括与穿刺推杆22近端连接的穿刺手柄26。推送手柄34的近端端部开设有一通孔，可供穿刺装置20的穿刺手柄26穿过，通孔大小与穿刺手柄26适配。穿刺手柄26部分位于推送手柄34的内腔中，部分位于推送手柄34外。穿刺推杆22的近端自推送导管32近端穿出并与穿刺手柄26相连接。通过穿刺手柄26的轴向移动，即可带动穿刺推杆22沿推送导管32的轴向移动，进而驱动穿刺针头24向远端穿刺或者向近端回撤。在瓣叶被夹持装置10夹持后，穿刺针头24可在穿刺手柄26驱动下，刺穿瓣叶并与缝合线60的固定件64连接，穿刺针头24与缝合线60通过固定件64连接成为一个整体，缝合线60不易与穿刺针头24脱离，操作者可方便快捷地将缝合线60与固定件64相连的一端或两端拉至心室壁或乳头肌的预定位置。Thepuncture device 20 also includes apuncture handle 26 connected to the proximal end of thepuncture push rod 22 . The proximal end of the push handle 34 defines a through hole for the puncture handle 26 of thepuncture device 20 to pass through, and the size of the through hole is adapted to thepuncture handle 26 . The puncture handle 26 is partially located in the inner cavity of the push handle 34 and partially located outside the push handle 34 . The proximal end of thepuncture push rod 22 protrudes from the proximal end of thepush catheter 32 and is connected to thepuncture handle 26 . Through the axial movement of thepuncture handle 26, thepuncture push rod 22 can be driven to move along the axial direction of thepush catheter 32, thereby driving thepuncture needle 24 to puncture the distal end or withdraw to the proximal end. After the valve leaflet is clamped by the clampingdevice 10 , thepuncture needle 24 can be driven by the puncture handle 26 to pierce the valve leaflet and connect with the fixingmember 64 of thesuture 60 , and thepuncture needle 24 and thesuture 60 are connected through the fixingmember 64 As a whole, thesuture 60 is not easily separated from thepuncture needle 24, and the operator can easily and quickly pull one or both ends of thesuture 60 connected with the fixingmember 64 to the predetermined position of the ventricular wall or papillary muscle.

穿刺装置20还包括保险件28。保险件28活动套设于穿刺手柄26外并活动穿装于推送手柄34。保险件28用于锁定穿刺手柄26以限制穿刺手柄26沿轴向移动，以避免在不需要穿刺时操作者误触发穿刺手柄26。本实施方式中，保险件28与穿刺手柄26能够发生干涉从而锁定穿刺手柄26，推送手柄34开设有贯通内外表面的安装槽3422(如图9与图10所示)，保险件28穿设于安装槽3422中。推送手柄34的内表面设有支撑件346，用于支撑穿刺手柄26及穿刺推杆22，从而使穿刺手柄26在推送手柄34的内腔中的高度固定。支撑件346设有卡槽3462，用于容纳部分保险件28。The piercingdevice 20 also includes asafety member 28 . Thesafety piece 28 is movably sleeved on the outside of the puncture handle 26 and movably worn on the push handle 34 . Thesafety piece 28 is used to lock the puncture handle 26 to limit the axial movement of the puncture handle 26 so as to prevent the operator from accidentally triggering the puncture handle 26 when puncturing is not required. In this embodiment, thesafety element 28 can interfere with the puncture handle 26 to lock thepuncture handle 26 . The push handle 34 is provided with aninstallation groove 3422 penetrating the inner and outer surfaces (as shown in FIG. 9 and FIG. 10 ). Mountingslot 3422. The inner surface of the push handle 34 is provided with asupport member 346 for supporting the puncture handle 26 and thepuncture push rod 22 , so that the height of the puncture handle 26 in the inner cavity of the push handle 34 is fixed. Thesupport member 346 is provided with acard slot 3462 for accommodating part of thesafety member 28 .

请参阅图17，保险件28整体呈倒凸字型，保险件28包括连接设置的按压部282与连接部284，按压部282用于供操作者按压操作。连接部284包括连接的第一连接部2842与第二连接部2844，第一连接部2842的径向尺寸小于第二连接部2844的径向尺寸，第一连接部2842与卡槽3462滑动连接。按压部282连接第二连接部2844远离第一连接部2842的一端。在穿刺手柄26与保险件28处于锁定状态时，按压部282被按压使保险件28朝向卡槽3462的底面移动，使第一连接部2842填充卡槽3462，从而可解除保险件28与穿刺手柄26之间的锁定。Referring to FIG. 17 , thesafety member 28 is in the shape of an inverted convex shape as a whole. Thesafety member 28 includes apressing portion 282 and a connectingportion 284 that are connected and provided. Thepressing portion 282 is used for the operator to press and operate. The connectingportion 284 includes a connected first connectingportion 2842 and a second connectingportion 2844 . The radial dimension of the first connectingportion 2842 is smaller than that of the second connectingportion 2844 , and the first connectingportion 2842 is slidably connected to theslot 3462 . Thepressing portion 282 is connected to one end of the second connectingportion 2844 away from the first connectingportion 2842 . When the puncture handle 26 and thesafety member 28 are in the locked state, thepressing portion 282 is pressed to move thesafety member 28 toward the bottom surface of thecard slot 3462, so that the first connectingportion 2842 fills thecard slot 3462, so that thesafety member 28 and the puncture handle can be released. Lock between 26.

第一连接部2842设有第一容置槽281，第二连接部2844设有与第一容置槽281连通的第二容置槽283，第二容置槽283的径向空间大于第一容置槽281的径向空间，穿刺手柄26活动地穿装在第二容置槽283并与第二容置槽283的间隙配合。穿刺手柄26穿设于保险件28中与保险件28配合，减小两者配合空间，有利于瓣膜缝合器100减小尺寸。The first connectingportion 2842 is provided with a firstaccommodating groove 281 , the second connectingportion 2844 is provided with a secondaccommodating groove 283 communicating with the firstaccommodating groove 281 , and the radial space of the secondaccommodating groove 283 is larger than that of the firstaccommodating groove 283 . In the radial space of theaccommodating groove 281 , the puncture handle 26 is movably inserted into the secondaccommodating groove 283 and fits with the clearance of the secondaccommodating groove 283 . The puncture handle 26 is penetrated in thesafety piece 28 to cooperate with thesafety piece 28 , so as to reduce the space between the two, which is beneficial to the size reduction of thevalve stapler 100 .

较为具体的，请再次参阅图16，穿刺手柄26朝向卡槽3462的一侧设有干涉部262，干涉部262两侧凹陷形成第一凸块2622及轴肩2623。第一凸块2622穿设于第一容置槽281时，轴肩2623抵持第一连接部2842，阻止穿刺手柄26的轴向移动，实现保险件28锁定穿刺手柄26，即保险件28与穿刺手柄26处于锁定状态。本实施方式中，穿刺手柄26的整体径向尺寸与第二容置槽283的径向尺寸配合。当第一凸块2622穿设于第二容置槽283时，轴肩2623也位于第二容置槽283中，轴肩2623未抵持第一连接部2842与第二连接部2844，穿刺手柄26可在第二容置槽283中沿轴向相对保险件28移动，即保险件28与穿刺手柄26处于解锁状态。More specifically, please refer to FIG. 16 again, the side of the puncture handle 26 facing theslot 3462 is provided with aninterference portion 262 , and thefirst protrusions 2622 and theshaft shoulders 2623 are recessed on both sides of theinterference portion 262 . When thefirst bump 2622 is inserted into the firstaccommodating groove 281, theshaft shoulder 2623 abuts against the first connectingportion 2842, preventing the axial movement of thepuncture handle 26, so that thesafety member 28 locks thepuncture handle 26, that is, thesafety member 28 and the puncture handle 26 are locked. The piercinghandle 26 is in a locked state. In this embodiment, the overall radial dimension of the puncture handle 26 matches the radial dimension of the secondaccommodating groove 283 . When thefirst protrusion 2622 is inserted through the secondaccommodating groove 283, theshaft shoulder 2623 is also located in the secondaccommodating groove 283, and theshaft shoulder 2623 does not abut against the first connectingportion 2842 and the second connectingportion 2844, and the puncture handle 26 can move relative to thesafety piece 28 in the axial direction in the secondaccommodating groove 283 , that is, thesafety piece 28 and the puncture handle 26 are in an unlocked state.

请再次参阅图13与图17，穿刺手柄26背向卡槽3462的一侧还设有滑槽264，即穿刺手柄26朝向按压部282的一侧设有滑槽264，第二连接部2844还设有第三容置槽285，第三容置槽285连通第二容置槽283远离第一容置槽281的一端。第三容置槽285的内表面设有第二凸块2822，在穿刺手柄26位于第二容置槽283及第三容置槽285时，第二凸块2822至少部分收容于滑槽264中。穿刺手柄26沿轴向相对保险件28移动时，第二凸块2822能够沿滑槽264移动，对穿刺手柄26相对保险件28的移动进行导向，提高了穿刺手柄26相对保险件28的移动的顺畅性及稳定性。本实施方式中，第三容置槽285的径向空间大于第二容置槽283的径向空间。可以理解，第三容置槽285的径向空间可小于或等于第二容置槽283的径向空间，保证第二凸块2822能够插入滑槽264即可。当然，第三容置槽285与第二凸块2822可以省略。Please refer to FIG. 13 and FIG. 17 again, the side of the puncture handle 26 facing away from thecard slot 3462 is further provided with a slidinggroove 264, that is, the side of the puncturing handle 26 facing thepressing portion 282 is provided with a slidinggroove 264, and the second connectingportion 2844 is also provided with a slidinggroove 264. A thirdaccommodating groove 285 is provided, and the thirdaccommodating groove 285 communicates with an end of the secondaccommodating groove 283 away from the firstaccommodating groove 281 . The inner surface of the thirdaccommodating groove 285 is provided with asecond protrusion 2822 . When the puncture handle 26 is located in the secondaccommodating groove 283 and the thirdaccommodating groove 285 , thesecond protrusion 2822 is at least partially accommodated in the slidinggroove 264 . When the puncture handle 26 moves relative to thesafety piece 28 in the axial direction, thesecond protrusion 2822 can move along thechute 264 to guide the movement of the puncture handle 26 relative to thesafety piece 28 , thereby improving the movement of the puncture handle 26 relative to thesafety piece 28 . Smoothness and stability. In this embodiment, the radial space of the thirdaccommodating groove 285 is larger than the radial space of the secondaccommodating groove 283 . It can be understood that the radial space of the thirdaccommodating groove 285 may be smaller than or equal to the radial space of the secondaccommodating groove 283 , as long as thesecond protrusion 2822 can be inserted into the slidinggroove 264 . Of course, the thirdaccommodating groove 285 and thesecond bump 2822 can be omitted.

保险件28锁定穿刺手柄26时，按压部282收容于安装槽3422内，按压部282能够受力带动保险件28整体朝向卡槽3462的底面移动。本实施方式中，在保险件28与穿刺手柄26处于锁定状态时，按压部282填满安装槽3422并且按压部282的背离卡槽3462的表面与推送手柄34的外表面基本平齐，第一连接部2842卡设于卡槽3462并且第一连接部2842朝向卡槽3462的底面的表面与卡槽3462的底面存在一定距离。此时，第一凸块2622位于第一容置槽281内，第一连接部2842与轴肩2623阻挡穿刺手柄26向远端推送及移动。When thesafety member 28 locks thepuncture handle 26 , thepressing portion 282 is accommodated in theinstallation groove 3422 , and thepressing portion 282 can be forced to drive thesafety member 28 to move toward the bottom surface of thelocking groove 3462 . In this embodiment, when thesafety piece 28 and the puncture handle 26 are in a locked state, thepressing portion 282 fills the mountinggroove 3422 and the surface of thepressing portion 282 facing away from thecard groove 3462 is substantially flush with the outer surface of the push handle 34 . The connectingportion 2842 is clamped in thecard slot 3462 , and the surface of the first connectingportion 2842 facing the bottom surface of thecard slot 3462 has a certain distance from the bottom surface of thecard slot 3462 . At this time, thefirst protrusion 2622 is located in the firstaccommodating groove 281, and the first connectingportion 2842 and theshaft shoulder 2623 prevent the puncture handle 26 from being pushed and moved distally.

当瓣膜缝合器100需要穿刺装置20进行穿刺时，按压部282被按压受力朝向卡槽3462移动，第一连接部2842填充卡槽3462，第一连接部2842朝向卡槽3462的底面的表面与卡槽3462的底面接触。此时，第一凸块2622脱离第一容置槽281，穿刺手柄26整体位于第二容置槽283和第三容置槽281中，穿刺手柄26可沿轴向推送及移动，第二凸块2822在滑槽264内滑动，保证穿刺手柄26推送的稳定性。When thevalve stapler 100 needs thepuncturing device 20 for puncturing, thepressing portion 282 is pressed and forced to move toward theslot 3462, the first connectingportion 2842 fills theslot 3462, and the surface of the first connectingportion 2842 facing the bottom surface of theslot 3462 is the same as the bottom surface of the first connectingportion 2842. The bottom surface of thecard slot 3462 is in contact. At this time, thefirst protrusion 2622 is separated from the firstaccommodating groove 281, the puncture handle 26 is integrally located in the secondaccommodating groove 283 and the thirdaccommodating groove 281, the puncture handle 26 can be pushed and moved in the axial direction, the second convex Theblock 2822 slides in thechute 264 to ensure the stability of the pushing of thepuncture handle 26 .

请再次参阅图4和图8，探测装置50用于检测瓣叶是否被夹持在远端夹头14和近端夹头16之间。探测装置50包括至少一个探针52及连接于每个探针52近端的探针操控机构54。探针52活动地穿装在推送手柄54的内腔及推送导管32中，用于探测夹持装置10是否夹持瓣膜的瓣叶及对瓣叶的夹持效果。探针操控机构54设于推送手柄34并能相对推送手柄34移动，用于驱动探针52伸出(向远端移动)推送导管32或缩回(向近端移动)推送导管32。本实施方式中，探测装置50包括两个探针52，两个探针52并列设置，且两个探针52与夹持推杆12之间的距离大致相等。Referring again to FIGS. 4 and 8 , thedetection device 50 is used to detect whether the leaflets are clamped between thedistal collet 14 and theproximal collet 16 . Theprobe device 50 includes at least oneprobe 52 and aprobe manipulation mechanism 54 attached to the proximal end of eachprobe 52 . Theprobe 52 is movably inserted into the inner cavity of the push handle 54 and thepush catheter 32 for detecting whether the clampingdevice 10 clamps the valve leaflets of the valve and the clamping effect on the valve leaflets. Theprobe manipulation mechanism 54 is disposed on the push handle 34 and can move relative to the push handle 34 for driving theprobe 52 to extend (moves distally) thepush catheter 32 or retract (moves proximally) thepush catheter 32 . In this embodiment, thedetection device 50 includes twoprobes 52 , the twoprobes 52 are arranged side by side, and the distances between the twoprobes 52 and the clampingpush rod 12 are substantially equal.

探针52的轴向长度优选为大于推送导管32的轴向长度。探针52活动地穿装在推送导管32中。近端夹头16的夹持面设有探针出口162，便于探针52的远端自推送导管中从探针出口162中伸出。对应的，远端夹头14的夹持面设有与探针出口162相对的、用于容纳探针52远端的探针收容腔146。当近端夹头16与远端夹头14闭合时，探针52的远端自探针出口162伸出后收容于探针收容腔146中。The axial length ofprobe 52 is preferably greater than the axial length ofpush catheter 32 . Theprobe 52 is movably inserted into thepush catheter 32 . The clamping surface of theproximal collet 16 is provided with aprobe outlet 162, so that the distal end of theprobe 52 can be protruded from theprobe outlet 162 from the pushing catheter. Correspondingly, the clamping surface of thedistal end collet 14 is provided with a probeaccommodating cavity 146 opposite to theprobe outlet 162 for accommodating the distal end of theprobe 52 . When theproximal collet 16 and thedistal collet 14 are closed, the distal end of theprobe 52 protrudes from theprobe outlet 162 and is accommodated in theprobe receiving cavity 146 .

探针52包括具有一定长度的探针主体，探针主体可以为实心或者空心结构。探针主体可以由金属材料、聚合物材料或者金属-聚合物材料制成。例如，探针主体可以是单层或者多层复合结构的实心杆状或空心管状结构，还可以由单根丝或者多根丝绕制而成。Theprobe 52 includes a probe body having a certain length, and the probe body can be a solid or hollow structure. The probe body may be made of metallic material, polymeric material or metal-polymeric material. For example, the probe body can be a solid rod-shaped or hollow tubular structure with a single-layer or multi-layer composite structure, and can also be wound from a single wire or multiple wires.

当近端夹头16与远端夹头14闭合时，如果瓣叶被夹持在近端夹头16与远端夹头14之间，且瓣叶边缘与夹持推杆12接触，探针52远端自近端夹头16的夹持面穿出后就会受到瓣叶的阻挡无法继续向远端前进，表明瓣叶夹持效果较好，可以进行穿刺。此外，当探针52远端受到瓣叶阻挡不能进入探针收容腔时，也表明瓣叶边缘与缝合线主体62之间的位置相对固定，提高治疗效果。因此，通过机械结构的探针52即可有效地探测瓣叶夹持效果，器械结构简单、操作方便。When theproximal collet 16 and thedistal collet 14 are closed, if the leaflet is clamped between theproximal collet 16 and thedistal collet 14 and the leaflet edge is in contact with theclamping pusher 12, the probe After the distal end of 52 passes through the clamping surface of theproximal collet 16, it will be blocked by the valve leaflet and cannot continue to advance to the distal end, indicating that the valve leaflet has a better clamping effect and can be punctured. In addition, when the distal end of theprobe 52 is blocked by the valve leaflet and cannot enter the probe receiving cavity, it also indicates that the position between the leaflet edge and thesuture body 62 is relatively fixed, which improves the treatment effect. Therefore, the valve leaflet clamping effect can be effectively detected by theprobe 52 of the mechanical structure, and the device has a simple structure and is convenient to operate.

请再次参阅图9、图13与图14，探针操控机构54还包括与探针52近端固定连接的滑动件542，滑动件542沿轴向滑动设于推送手柄34。滑动件542轴向滑动时驱动探针52沿轴向移动。Referring again to FIGS. 9 , 13 and 14 , theprobe manipulation mechanism 54 further includes a slidingmember 542 fixedly connected to the proximal end of theprobe 52 . The slidingmember 542 is axially slidably disposed on the push handle 34 . When the slidingmember 542 slides axially, theprobe 52 is driven to move in the axial direction.

本实施方式中，探针52的数量为两个，滑动件542的数量对应探针52的数量为两个。推送手柄34的第二壳体344的内表面设有关于推送手柄34的中轴线对称的两个滑动槽3441(如图9所示)，每个滑动件542可在对应的滑动槽3441沿轴向移动。第一壳体342还设有与两个滑动槽3441一一对应的两个操控通槽3426，探针操控机构54还包括设于滑动件542上的操控件544，操控件544穿装于操控通槽3426中，操控件544用于驱动滑动件542沿推送手柄34的轴向滑动。两个操控件544分别自两个操控通槽3426露出并卡设在第一壳体342的外表面。操控通槽3426可以起到限制探针操控机构54沿轴向的移动距离的作用。每个探针52的近端分别与对应的滑动件542固定连接，操作者沿轴向控制操控件544，即可带动滑动件542沿轴向移动，从而驱动探针52自推送导管32中穿出或将探针52收回推送导管32中。In this embodiment, the number of theprobes 52 is two, and the number of thesliders 542 corresponds to the number of theprobes 52 being two. The inner surface of thesecond housing 344 of the push handle 34 is provided with two sliding grooves 3441 (as shown in FIG. 9 ) that are symmetrical with respect to the central axis of the push handle 34 . to move. Thefirst housing 342 is further provided with two control throughgrooves 3426 corresponding to the two slidinggrooves 3441 one-to-one. Theprobe control mechanism 54 further includes acontrol member 544 disposed on the slidingmember 542, and thecontrol member 544 is mounted on the control member. In the throughgroove 3426 , themanipulation member 544 is used to drive the slidingmember 542 to slide along the axial direction of the push handle 34 . The twomanipulation members 544 are respectively exposed from the two manipulation throughgrooves 3426 and clamped on the outer surface of thefirst housing 342 . The manipulation throughgroove 3426 can function to limit the moving distance of theprobe manipulation mechanism 54 in the axial direction. The proximal end of eachprobe 52 is fixedly connected to the corresponding slidingmember 542 respectively. The operator controls themanipulation member 544 in the axial direction to drive the slidingmember 542 to move in the axial direction, thereby driving theprobe 52 to pass through the pushingcatheter 32 . out or retract theprobe 52 into thepusher catheter 32 .

操控件544沿径向朝向推送手柄34的中轴线所在一侧设有指示部5442(如图15所示)，第一壳体342的外表面在两个操控通槽3426之间设有标识341(如图10所示)。在本实施方式中，标识341包括第一标识3411及第二标识3412，第一标识3411与第二标识3412为两种不同的颜色，例如第一标识3411为红色，第二标识3412为绿色。分别控制两个操控件544向远端移动，如图26a、图26b、图26c所示，当至少一个指示部5442指向第一标识3411时，说明瓣叶夹持效果差；如图27所示，当两个指示部5442均指向第二标识3412时，说明瓣叶夹持效果好。可以理解，不限定第一标识3411与第二标识3412为颜色，第一标识3411与第二标识3412可以通过其他形式进行区别，例如，不同的字母等。An indication portion 5442 (as shown in FIG. 15 ) is provided on the side of thecontrol member 544 radially toward the central axis of the push handle 34 , and anindication 341 is provided on the outer surface of thefirst housing 342 between the two control through grooves 3426 (as shown in Figure 10). In this embodiment, thelogo 341 includes afirst logo 3411 and asecond logo 3412, thefirst logo 3411 and thesecond logo 3412 are two different colors, for example, thefirst logo 3411 is red, and thesecond logo 3412 is green. Control the twomanipulation members 544 to move to the distal end respectively, as shown in Figure 26a, Figure 26b, Figure 26c, when at least oneindicator 5442 points to thefirst mark 3411, it means that the valve leaflet clamping effect is poor; as shown in Figure 27 , when the twoindication parts 5442 both point to thesecond mark 3412, it means that the valve leaflet has a good clamping effect. It can be understood that thefirst logo 3411 and thesecond logo 3412 are not limited to be colors, and thefirst logo 3411 and thesecond logo 3412 can be distinguished by other forms, for example, different letters and the like.

请再次参阅图13与图14，探针操控机构54还包括沿径向延伸的导滑轨546，导滑轨546设于滑动件542上，操控件544滑动连接于导滑轨546。具体地，导滑轨546具有导滑槽5460，操控件544可卡设于导滑轨546的导滑槽5460中并沿径向移动。操控通槽3426呈L型，包括轴向槽3427和连接轴向槽3427近端的径向槽3428(如图10所示)。径向槽3428的设置，可供操控件544沿径向移动，当操控件544处于径向槽3428中，探针52完全收容于推送导管32中，此时操控件544无法带动滑动件542沿轴向移动，从而可保持探针52收容于推送导管32中，避免手术过程中误操作。13 and 14 again, theprobe manipulation mechanism 54 further includes aguide rail 546 extending radially. Specifically, theguide rail 546 has aguide groove 5460 , and themanipulation member 544 can be clamped in theguide groove 5460 of theguide rail 546 and move in the radial direction. The manipulation throughgroove 3426 is L-shaped and includes anaxial groove 3427 and aradial groove 3428 connecting the proximal end of the axial groove 3427 (as shown in FIG. 10 ). Theradial groove 3428 is provided for themanipulation member 544 to move in the radial direction. When themanipulation member 544 is in theradial groove 3428, theprobe 52 is completely accommodated in thepush conduit 32, and themanipulation member 544 cannot drive the slidingmember 542 along the radial direction. Axial movement, so as to keep theprobe 52 contained in thepush catheter 32 to avoid misoperation during the operation.

进一步地，推送手柄34的第二壳体344的内表面设有定位槽349(如图10所示)，探针操控机构54还包括定位件35和定位杆548。定位件35卡设于定位槽349内，定位件35开设有定位孔352以供定位杆548穿过，定位杆548的远端固定于滑动件542。探针操控机构54还包括推送弹性件(例如弹簧，图未示)，定位杆548穿装于推送弹性件中，推送弹性件的近端收容于定位孔352中且远端抵接推送手柄34。操控件544处于径向槽3428时，探针52完全位于推送导管32中，定位件35压缩推送弹性件；操控件544由径向槽3428移动至轴向槽3427时，探针52的远端在推送弹性件的弹性作用下从推送导管32的远端伸出。Further, the inner surface of thesecond housing 344 of the push handle 34 is provided with a positioning groove 349 (as shown in FIG. 10 ), and theprobe manipulation mechanism 54 further includes a positioningmember 35 and apositioning rod 548 . The positioningmember 35 is clamped in thepositioning groove 349 . The positioningmember 35 defines apositioning hole 352 for thepositioning rod 548 to pass through. The distal end of thepositioning rod 548 is fixed to the slidingmember 542 . Theprobe manipulation mechanism 54 further includes a push elastic member (such as a spring, not shown), thepositioning rod 548 is inserted into the push elastic member, the proximal end of the push elastic member is accommodated in thepositioning hole 352 and the distal end abuts against the push handle 34 . When themanipulation member 544 is in theradial groove 3428, theprobe 52 is completely located in the pushingcatheter 32, and the positioningmember 35 compresses the push elastic member; when themanipulation member 544 moves from theradial groove 3428 to theaxial groove 3427, the distal end of theprobe 52 It protrudes from the distal end of the pushingcatheter 32 under the elastic action of the pushing elastic member.

较为具体地，在初始状态，操控件544处于径向槽3428中，定位杆548上的推送弹性件被压缩，探针52收容在推送导管32中。当将操控件544由径向槽3427移动至轴向槽3428，由于定位杆548上的推送弹性件由压缩状态恢复至自然状态产生弹力，可直接将探针52的远端从推送导管中32推出。More specifically, in the initial state, themanipulation member 544 is in theradial groove 3428 , the pushing elastic member on thepositioning rod 548 is compressed, and theprobe 52 is accommodated in the pushingconduit 32 . When the manipulatingmember 544 is moved from theradial groove 3427 to theaxial groove 3428, since the pushing elastic member on thepositioning rod 548 returns from the compressed state to the natural state to generate elastic force, the distal end of theprobe 52 can be directly pushed out of the pushingcatheter 32. roll out.

请参阅图7b、图18和图19，为了进一步加强夹持，瓣膜缝合器100还包括夹持辅助装置40。夹持辅助装置40包括至少一个夹持辅助臂42(图18中仅示例性的示出一个)及设于夹持辅助臂42远端的夹持辅助件44。夹持辅助臂42活动地穿装于推送导管32中。夹持辅助件42由弹性和/或柔性材料制成，夹持辅助臂42用于推动与其相连的夹持辅助件42从推送导管32的远端或夹持装置10的远端穿出，夹持辅助件42用于与夹持装置10配合夹持瓣叶。Referring to FIGS. 7b , 18 and 19 , in order to further enhance the clamping, thevalve stapler 100 further includes a clampingauxiliary device 40 . The grippingaid 40 includes at least one gripping aid arm 42 (only one is exemplarily shown in FIG. 18 ) and agripping aid 44 provided at the distal end of thegripping aid arm 42 . The clampingauxiliary arm 42 is movably inserted into the pushingconduit 32 . The grippingaid 42 is made of elastic and/or flexible material, and thegripping aid arm 42 is used to push thegripping aid 42 connected to it to pass through the distal end of the pushingcatheter 32 or the distal end of thegripping device 10, and thegripping aid 42 is used to push thegripping aid 42 connected to it through the distal end of the pushingcatheter 32 or the distal end of thegripping device 10. The holdingaid 42 is used for holding the leaflet in cooperation with the holdingdevice 10 .

进一步地，请再次参阅图9与图18，夹持辅助装置40还包括连接于夹持辅助臂42近端的辅助操纵机构46，辅助操纵机构46设于推送手柄34。夹持辅助臂42的近端自推送导管32中穿出并设置辅助操纵机构46。近端夹头16的夹持面、推送导管32的侧面或近端夹头16的侧面设有辅助件出口321。因此，辅助操纵机构46可驱动夹持辅助臂42推动夹持辅助件44从推送导管32远端或夹持装置10远端穿出。Further, please refer to FIGS. 9 and 18 again, the clampingauxiliary device 40 further includes anauxiliary operating mechanism 46 connected to the proximal end of the clampingauxiliary arm 42 , and theauxiliary operating mechanism 46 is provided on the push handle 34 . The proximal end of the clampingauxiliary arm 42 passes through the pushingcatheter 32 and is provided with anauxiliary manipulation mechanism 46 . The clamping surface of theproximal collet 16 , the side surface of the pushingcatheter 32 or the side surface of theproximal collet 16 is provided with anauxiliary component outlet 321 . Therefore, the auxiliary manipulatingmechanism 46 can drive the clampingauxiliary arm 42 to push the clampingaid 44 out of the distal end of the pushingcatheter 32 or the distal end of theclamping device 10 .

推送导管32中沿轴向设有辅助臂收容腔328。在瓣膜缝合器100的穿刺装置20穿刺前，夹持辅助件44和夹持辅助臂42均收容在辅助臂收容腔328中。在本实施方式中，近端夹头16的侧面设置有辅助件出口321(如图9所示)，辅助件出口321与辅助臂收容腔328相贯通。操作者向远端推送辅助操纵机构46，可驱动夹持辅助臂42推动夹持辅助件44从辅助件出口321中穿出，从而支撑在瓣叶的下表面，稳定搏动的瓣叶，减小瓣叶的活动幅度，与夹持装置10配合以夹持并固定瓣叶。An auxiliary armaccommodating cavity 328 is provided in the pushingconduit 32 along the axial direction. Before thepuncturing device 20 of thevalve stapler 100 is punctured, the clampingauxiliary member 44 and the clampingauxiliary arm 42 are both accommodated in the auxiliary armaccommodating cavity 328 . In this embodiment, an auxiliary component outlet 321 (as shown in FIG. 9 ) is provided on the side of theproximal collet 16 , and theauxiliary component outlet 321 communicates with the auxiliaryarm receiving cavity 328 . The operator pushes theauxiliary manipulation mechanism 46 to the distal end, which can drive the clampingauxiliary arm 42 to push the clampingauxiliary piece 44 to pass through theauxiliary piece outlet 321, so as to support the lower surface of the valve leaflet, stabilize the pulsating valve leaflet, and reduce the The range of motion of the valve leaflet cooperates with the clampingdevice 10 to clamp and fix the valve leaflet.

夹持辅助臂42为具有一定轴向长度的杆状或管状结构，且具有一定硬度或刚度以提供支撑性及可推送性。夹持辅助臂42可以由单层或者多层复合结构的空心或实心结构的金属杆或高分子材料杆制成，还可以由单根丝或者多根丝绕制而成。夹持辅助臂42可以由金属材料、聚合物材料或者金属-聚合物复合材料制成。The clampingauxiliary arm 42 is a rod-shaped or tubular structure with a certain axial length, and has a certain hardness or rigidity to provide support and pushability. The clampingauxiliary arm 42 may be made of a hollow or solid metal rod or a polymer material rod of a single-layer or multi-layer composite structure, and may also be wound from a single wire or multiple wires. Thegripping assist arm 42 may be made of a metal material, a polymer material or a metal-polymer composite material.

请参阅图20，夹持辅助件44支撑在瓣叶200下表面并与夹持装置10配合夹持瓣叶200。由于夹持辅助件44由弹性和/或柔性材料制成，其能够适应瓣叶200的解剖结构及瓣叶200的活动幅度，并避免损伤瓣叶200。弹性材料优选为形状记忆材料。夹持辅助件44可以由金属材料、聚合物材料或者金属-聚合物复合材料制成。本实施方式中，夹持辅助件44由带有形状记忆功能的弹性镍钛合金制成。Referring to FIG. 20 , the clampingaid 44 is supported on the lower surface of theleaflet 200 and cooperates with the clampingdevice 10 to clamp theleaflet 200 . Since the grippingaid 44 is made of an elastic and/or flexible material, it can accommodate the anatomy of theleaflet 200 and the range of motion of theleaflet 200 and avoid damage to theleaflet 200 . The elastic material is preferably a shape memory material. The grippingaid 44 may be made of metallic material, polymeric material or metal-polymer composite material. In this embodiment, the clampingauxiliary member 44 is made of elastic Nitinol with shape memory function.

为了便于在推送导管32中被推送，夹持辅助件44包括压缩状态及自然状态时的伸展状态。夹持辅助件44在压缩状态时，可收容在推送导管22的辅助臂收容腔328中并被推送。当夹持辅助件44由辅助件出口321中伸出后，转变为伸展状态，可支撑在瓣叶200的下表面，稳定搏动的瓣叶200。本实施方式中，夹持辅助件44为由多根金属丝编织而成的网状结构。网状结构可以进一步热定型处理形成球状、柱状、巢状、扁圆状等结构。优选地，夹持辅助件44为编织网球状结构，在压缩状态时，编织网球状结构被径向压缩收容在辅助臂收容腔328中；在伸展状态时，编织网球状结构由辅助件出口321被推出自膨胀径向扩张成球状。To facilitate being pushed in thepush conduit 32, the grippingaid 44 includes a compressed state and an extended state in its natural state. When the clampingaid 44 is in a compressed state, it can be accommodated in the auxiliary armaccommodating cavity 328 of the pushingconduit 22 and pushed. After the clampingaid 44 protrudes from theoutlet 321 of the aid, it is transformed into an extended state, and can be supported on the lower surface of thevalve leaflet 200 to stabilize the pulsatingvalve leaflet 200 . In this embodiment, the clampingauxiliary member 44 is a mesh structure woven by a plurality of metal wires. The mesh structure can be further heat-set to form spherical, columnar, nested, oblate and other structures. Preferably, the clampingauxiliary member 44 is a woven tennis ball-shaped structure, and in the compressed state, the woven tennis-shaped structure is radially compressed and accommodated in the auxiliaryarm receiving cavity 328; in the extended state, the woven tennis-shaped structure is received from theauxiliary member outlet 321 The self-expanding radially expands into a spherical shape by being pushed out.

直径较大的夹持辅助件44与瓣叶200的接触面即为夹持辅助件44所在的平面，因此，夹持辅助装置40与瓣叶之间的接触面积更大，可以更好地贴合瓣叶，提高夹持辅助装置40对瓣叶的支撑性。夹持辅助件44外形光滑，夹持辅助件44的远端可通过激光点焊等工艺形成光滑的圆头，没有毛刺、棱边或棱角等缺陷。可以理解，本申请不限定为夹持辅助件44为网状结构，在其他实施方式中，夹持辅助件44还可包括一根支撑杆或者由多根支撑杆构成的变形结构，变形结构为由多根支撑杆构成的开放式的分叉结构、伞状结构或者闭环结构，夹持辅助件44能够支撑在瓣叶下表面并与夹持装置10配合夹持瓣叶即可。The contact surface of the clampingauxiliary device 44 with the larger diameter and thevalve leaflet 200 is the plane where the clampingauxiliary member 44 is located. Therefore, the contact area between the clampingauxiliary device 40 and the valve leaflet is larger, which can better adhere to the valve. The valve leaflets are combined, and the supportability of the valve leaflets by the clampingauxiliary device 40 is improved. The clampingauxiliary member 44 has a smooth shape, and the distal end of the clampingauxiliary member 44 can be formed into a smooth round head by a process such as laser spot welding, without defects such as burrs, edges or corners. It can be understood that the present application is not limited to the fact that the clampingauxiliary member 44 is a mesh structure. In other embodiments, the clampingauxiliary member 44 may further include a support rod or a deformation structure composed of a plurality of support rods, and the deformation structure is In an open bifurcated structure, an umbrella-shaped structure or a closed-loop structure composed of a plurality of support rods, the clampingauxiliary member 44 can be supported on the lower surface of the valve leaflet and cooperate with the clampingdevice 10 to clamp the valve leaflet.

请再次参阅图9与图18，辅助操纵机构46设于推送手柄34。具体地，推送手柄34的第二壳体344内表面设有滑行槽3448(如图9所示)，第一壳体342设有对应的操纵通槽3424。辅助操纵机构46包括滑行件462和设于滑行件462上的操纵件464。夹持辅助臂42的近端与滑行件462固定连接，滑行件462可在滑行槽3448沿轴向移动，操纵件464自操纵通槽3424露出并卡设在第一壳体342外表面。操纵通槽3424可以起到限制辅助操纵机构46沿轴向的移动距离的作用。操纵件464沿操纵通槽3424的轴向移动可带动滑行件462在滑行槽3448沿轴向移动，从而推动夹持辅助臂42带动夹持辅助件44自辅助臂收容腔328从辅助件出口321中穿出或将夹持辅助件44收回辅助臂收容腔328中。Please refer to FIG. 9 and FIG. 18 again, theauxiliary operating mechanism 46 is provided on the push handle 34 . Specifically, the inner surface of thesecond casing 344 of the push handle 34 is provided with a sliding groove 3448 (as shown in FIG. 9 ), and thefirst casing 342 is provided with a corresponding manipulation throughgroove 3424 . Theauxiliary operating mechanism 46 includes a slidingmember 462 and an operatingmember 464 provided on the slidingmember 462 . The proximal end of the clampingauxiliary arm 42 is fixedly connected with the slidingmember 462 . The slidingmember 462 can move in the axial direction in the slidinggroove 3448 . The manipulation throughgroove 3424 can function to limit the moving distance of theauxiliary manipulation mechanism 46 in the axial direction. The axial movement of the operatingmember 464 along the operating throughgroove 3424 can drive the slidingmember 462 to move in the axial direction in the slidinggroove 3448 , thereby pushing the clampingauxiliary arm 42 to drive the clampingauxiliary member 44 from the auxiliaryarm receiving cavity 328 from theauxiliary member outlet 321 The clampingaid 44 is passed through or retracted into the auxiliaryarm receiving cavity 328 .

进一步地，辅助操纵机构46还包括导轨466，导轨466设于滑行件462上，导轨466具有导轨槽，操纵件464可卡设于导轨槽沿径向移动。操纵通槽3424大致呈Z字型，包括轴向通槽和连接轴向通槽两端的径向通槽。操纵通槽3424的径向通槽的设置，可供操纵件464沿径向移动，当操纵件464处于操纵通槽3424的径向通槽中，操纵件464无法带动滑行件462向轴向移动，从而在需要保持夹持辅助件44收容在辅助臂收容腔328中或夹持辅助件44从辅助件出口321中穿出的状态时，可避免操作者误操作而沿轴向移动操纵件464。Further, theauxiliary operating mechanism 46 further includes aguide rail 466, theguide rail 466 is arranged on the slidingmember 462, theguide rail 466 has a guide rail groove, and the operatingmember 464 can be clamped in the guide rail groove to move in a radial direction. The manipulation throughslot 3424 is substantially Z-shaped, including an axial through slot and a radial through slot connecting two ends of the axial through slot. The arrangement of the radial through grooves of the manipulation throughgroove 3424 allows themanipulation member 464 to move in the radial direction. When themanipulation member 464 is in the radial through groove of the manipulation throughslot 3424, themanipulation member 464 cannot drive the slidingmember 462 to move axially. Therefore, when it is necessary to maintain the state in which the clampingauxiliary member 44 is accommodated in the auxiliary armaccommodating cavity 328 or the clampingauxiliary member 44 passes through theauxiliary member outlet 321, the operator can be prevented from moving the operatingmember 464 in the axial direction by mistaken operation. .

请参阅图21，推送导管32中沿轴向设有穿刺推杆通道322、夹持推杆通道324及探针通道326。夹持推杆12穿装于推送导管32的夹持推杆通道324中，穿刺推杆22穿装于推送导管32的穿刺推杆通道322中，探针52穿装于推送导管32的探针通道326中，以保证夹持推杆12、穿刺推杆22与探针52的轴向均与推送导管32的轴向大致平行。夹持推杆通道324设置于推送导管32的一侧，两个穿刺推杆通道322设置于推送导管32的另一侧。探针通道326设置在夹持推杆通道324与穿刺推杆通道322之间，且探针通道326与夹持推杆通道324之间的距离小于探针通道326与穿刺推杆通道322之间的距离。可以理解的是，当推送导管32中还设有辅助臂收容腔328时，辅助臂收容腔328设置在夹持推杆通道324与穿刺推杆通道322之间，探针通道326设置在夹持推杆通道324与辅助臂收容腔328之间，且探针通道326与夹持推杆通道324之间的距离小于探针通道326与穿刺推杆通道322之间的距离。Referring to FIG. 21 , the pushingconduit 32 is provided with a puncturepush rod channel 322 , a clampingpush rod channel 324 and aprobe channel 326 along the axial direction. The clampingpush rod 12 is inserted into the clampingpush rod channel 324 of thepush catheter 32 , thepuncture push rod 22 is inserted into the puncturepush rod channel 322 of thepush catheter 32 , and theprobe 52 is inserted into the probe of thepush catheter 32 In thechannel 326 , it is ensured that the axial directions of the clampingpush rod 12 , the puncturingpush rod 22 and theprobe 52 are substantially parallel to the axial direction of the pushingcatheter 32 . The clampingpush rod channel 324 is provided on one side of the pushingcatheter 32 , and the two puncturingpush rod channels 322 are provided on the other side of the pushingcatheter 32 . Theprobe channel 326 is disposed between the clampingpush rod channel 324 and the puncturingpush rod channel 322 , and the distance between theprobe channel 326 and the clampingpush rod channel 324 is smaller than that between theprobe channel 326 and the puncturingpush rod channel 322 the distance. It can be understood that when thepush catheter 32 is further provided with an auxiliary armaccommodating cavity 328, the auxiliary armaccommodating cavity 328 is disposed between the clampingpush rod channel 324 and the puncturepush rod channel 322, and theprobe channel 326 is disposed between the clampingpush rod channel 324 and the puncturepush rod channel 322. Between thepush rod channel 324 and the auxiliaryarm receiving cavity 328 , and the distance between theprobe channel 326 and the clampingpush rod channel 324 is smaller than the distance between theprobe channel 326 and the puncturepush rod channel 322 .

推送导管32可以采用一体成型的多腔管，也可以将外管和内管套装固定在一起形成整体结构的推送导管32。推送导管32可以采用生物相容性的高分子材料(例如，聚甲醛POM、聚乙烯PE、尼龙PA、聚氯乙烯PVC、丙烯腈-丁二烯-苯乙烯共聚物ABS、尼龙弹性体Pebax或者聚氨酯PU)、金属材料(例如，不锈钢或者镍钛合金)或者金属-高分子复合材料制成。Thepush catheter 32 can be an integrally formed multi-lumen tube, or the outer tube and the inner tube can be sheathed and fixed together to form thepush catheter 32 with an integral structure. Thepush catheter 32 can be made of biocompatible polymer materials (eg, polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or Polyurethane PU), metal materials (for example, stainless steel or Nitinol) or metal-polymer composite materials.

夹持操作机构18、辅助操纵机构46、探针操控机构54均设于推送手柄34，由远端至近端，依次为夹持操作机构18、辅助操纵机构46、探针操控机构。滑移件182开设有沿轴向的通孔，以供夹持辅助臂42、探针52、穿刺推杆22通过。滑行件462沿推送手柄34的中轴线的两侧分别设有沿轴向的通槽、通孔以供探针52、穿刺推杆22穿过。滑动件542沿径向朝向推送手柄34的中轴线设有支撑部5422(如图15所示)，支撑部5422与支撑件346的高度相同，共同支撑穿刺推杆22和穿刺手柄26。The clampingoperation mechanism 18 , theauxiliary operation mechanism 46 , and theprobe control mechanism 54 are all provided on the push handle 34 , from the distal end to the proximal end, the clampingoperation mechanism 18 , theauxiliary operation mechanism 46 , and the probe control mechanism are sequentially arranged. The slidingmember 182 is provided with a through hole along the axial direction for the clampingauxiliary arm 42 , theprobe 52 and thepuncture push rod 22 to pass through. Both sides of the slidingmember 462 along the central axis of the push handle 34 are respectively provided with axial through grooves and through holes for theprobe 52 and thepuncture push rod 22 to pass through. The slidingmember 542 is provided with asupport portion 5422 radially toward the central axis of the push handle 34 (as shown in FIG. 15 ).

请再次参阅图8，推送装置30还包括连通推送导管32的密封管36，密封管36位于推送手柄34的内腔中并与推送导管32的近端连接，穿刺装置20、探针52、夹持推杆及夹持辅助臂均活动穿装在密封管36中。本实施方式中，密封管36设有鲁尔接头362以用于连接排气管(图未示)排气。密封管36位于第一壳体342和第二壳体344之间形成的内腔中，推送手柄34的远端侧面开设有安装孔3440，用于安装鲁尔接头362。密封管36的远端外表面形成有螺纹，与一带内螺纹的安装件38螺纹连接，从而使推送导管32与推送手柄34固定连接。Please refer to FIG. 8 again, the pushingdevice 30 further includes a sealingtube 36 communicating with the pushingcatheter 32. The sealingtube 36 is located in the lumen of the pushinghandle 34 and is connected to the proximal end of the pushingcatheter 32. The puncturingdevice 20, theprobe 52, the clip Both the push rod and the clamping auxiliary arm are movably installed in the sealingtube 36 . In this embodiment, the sealingtube 36 is provided with aLuer connector 362 for connecting to an exhaust pipe (not shown) for exhaust gas. The sealingtube 36 is located in the inner cavity formed between thefirst housing 342 and thesecond housing 344 , and the distal side of the push handle 34 is provided with a mountinghole 3440 for mounting theluer connector 362 . The outer surface of the distal end of the sealingtube 36 is threaded, and is threadedly connected with a mountingmember 38 with an internal thread, so that thepush catheter 32 is fixedly connected with the push handle 34 .

密封管36的远端与推送导管32的近端连通，密封管36的近端开口且填充至少一个密封件37，密封件37设有通孔(图未示)以供穿刺装置20、探针52、夹持推杆及夹持辅助臂穿过。本实施方式中，密封件37包括密封硅胶。密封件37通过与密封管36的近端螺纹连接的固定螺帽33固定。推送导管32沿轴向设置多个相互分隔的贯通的内腔或通道，对应地，密封件37也设有多个相互分隔的通孔。可以理解，本申请对密封件37的材质不作限定，对密封件37与密封管36的连接方式不作限定，例如，在其他实施方式中，可以通过胶体粘接也可以通过卡合等方式。The distal end of the sealingtube 36 communicates with the proximal end of thepush catheter 32, the proximal end of the sealingtube 36 is open and filled with at least one sealing member 37, and the sealing member 37 is provided with a through hole (not shown) for thepuncture device 20, theprobe 52. Pass through the clamping push rod and the clamping auxiliary arm. In this embodiment, the sealing member 37 includes sealing silicone. The seal 37 is secured by a retainingnut 33 threaded to the proximal end of the sealingtube 36 . The pushingconduit 32 is provided with a plurality of mutually separated through cavities or channels along the axial direction, and correspondingly, the sealing member 37 is also provided with a plurality of mutually separated through holes. It can be understood that the material of the sealing member 37 is not limited in this application, and the connection method of the sealing member 37 and the sealingtube 36 is not limited.

以下以二尖瓣后叶夹持的腱索植入术为例，对本实施方式提供的瓣膜缝合器100的实施过程进行简单说明。The following briefly describes the implementation process of thevalve stapler 100 provided in this embodiment by taking the chordae tendineae implantation with the posterior leaflet of the mitral valve as an example.

第一步，请参见图22，先将瓣膜缝合器100推进至左心室内，继续推进瓣膜缝合器100直至远端夹头14及近端夹头16均位于左心房内。The first step, referring to FIG. 22 , is to advance thevalve stapler 100 into the left ventricle, and continue to advance thevalve stapler 100 until both thedistal collet 14 and theproximal collet 16 are located in the left atrium.

第二步，请参见图23，控制操作件1841向远端移动以向远端推送夹持推杆12，使得近端夹头16与远端夹头14分离，此时近端夹头16与远端夹头14之间形成瓣叶容纳空间。In the second step, referring to FIG. 23 , the operatingmember 1841 is controlled to move to the distal end to push the clampingpush rod 12 to the distal end, so that theproximal end collet 16 is separated from thedistal end collet 14 . At this time, theproximal end collet 16 and the A leaflet accommodating space is formed between thedistal collets 14 .

第三步，请参见图24，控制操纵件464向远端移动以驱动夹持辅助臂42推送夹持辅助件44从辅助件出口321中穿出，此时夹持辅助件44支撑在瓣叶下表面以协助稳定搏动的瓣叶，保持操作件1841和操纵件464之间的相对位置不变，向近端缓慢移动整个器械，直至瓣叶进入近端夹头16与远端夹头14之间形成的瓣叶容纳空间中，且夹持辅助件44可以对瓣叶提供一定的支撑力。In the third step, please refer to FIG. 24 , control themanipulation member 464 to move to the distal end to drive the clampingauxiliary arm 42 to push the clampingauxiliary member 44 to pass through theauxiliary member outlet 321 . At this time, the clampingauxiliary member 44 is supported on the valve leaflet. The lower surface is used to assist in stabilizing the pulsating valve leaflets, keeping the relative position between the operatingmember 1841 and the operatingmember 464 unchanged, and slowly moving the entire instrument proximally until the valve leaflet enters between theproximal collet 16 and thedistal collet 14. The valve leaflet accommodating space formed therebetween, and the clampingaid 44 can provide a certain support force to the valve leaflet.

第四步，请请参见图25，轻微移动瓣膜缝合器100的远端，直至瓣叶边缘与夹持推杆12接触，此时向近端后撤操作件1841，驱动远端夹头14向近端夹头16移动直至二者闭合，瓣叶被夹持。如操作者发现瓣叶未被有效夹持，可以微调远端夹头14与近端夹头16的相对位置使得二者之间产生一定距离，再调整夹持推杆12与瓣叶之间的相对位置。在调整的过程中，由于瓣叶下方的夹持辅助装置40对瓣叶具有一定的支撑作用，可以防止瓣叶从夹持装置10中滑脱。The fourth step, please refer to FIG. 25, slightly move the distal end of thevalve stapler 100 until the edge of the valve leaflet contacts with the clampingpush rod 12, at this time, the operatingmember 1841 is retracted to the proximal end, and thedistal collet 14 is driven to move toward the end. Theproximal collet 16 is moved until the two are closed and the leaflets are clamped. If the operator finds that the valve leaflet is not effectively clamped, he can fine-tune the relative position of thedistal collet 14 and theproximal collet 16 to create a certain distance between them, and then adjust the distance between the clampingpush rod 12 and the valve leaflet. relative position. During the adjustment process, since the clampingauxiliary device 40 under the valve leaflet has a certain supporting effect on the valve leaflet, the valve leaflet can be prevented from slipping out of theclamping device 10 .

第五步，保持推送手柄34位置不变，分别控制两个操控件544向远端移动以驱动探针52沿推送导管32的轴向向远端移动；如图26a至图26c所示，如果瓣叶夹持状态较差，即，瓣叶没有完全覆盖近端夹头16的夹持面上的探针出口162，探针52的远端可以自探针出口162伸出后进入远端夹头14的探针收容腔146，需要重复第二步至第四步的操作重新夹持瓣叶；如图27所示，如果瓣叶夹持状态良好，即，瓣叶完全覆盖近端夹头16的夹持面上的探针出口162，探针52的远端不能自探针出口162伸出并进入远端夹头14的探针收容腔146，此时分别操作两个操控件544向近端移动至操控通槽3426的径向槽3428中以驱动探针52收回至推送导管32即可以进行后续操作。The fifth step, keeping the position of the push handle 34 unchanged, respectively controls the twomanipulation members 544 to move distally to drive theprobe 52 to move distally along the axial direction of thepush catheter 32; as shown in FIGS. 26a to 26c , if Poor leaflet clamping, ie, the leaflet does not completely cover theprobe exit 162 on the clamping surface of theproximal collet 16, and the distal end of theprobe 52 can protrude from theprobe exit 162 into the distal collet Theprobe receiving cavity 146 of thehead 14 needs to repeat the operations from the second to the fourth step to re-clamp the valve leaflet; as shown in Figure 27, if the valve leaflet is in a good clamping state, that is, the valve leaflet completely covers the proximal collet Theprobe outlet 162 on the clamping surface of the 16, the distal end of theprobe 52 cannot protrude from theprobe outlet 162 and enter theprobe receiving cavity 146 of thedistal collet 14. At this time, the twocontrol members 544 are respectively operated to The proximal end moves into theradial slot 3428 of the steering throughslot 3426 to drive theprobe 52 to retract to thepush catheter 32 for subsequent operations.

第六步，如图28所示，按压保险件28的按压部282，解锁穿刺手柄26的锁定状态，此时可向远端推送穿刺手柄26，驱动穿刺针头24向远端移动，直至穿刺针头24穿过瓣叶200并与缝合线60的固定件64之间形成固定连接，如图30所示。The sixth step, as shown in FIG. 28 , press thepressing portion 282 of thesafety member 28 to unlock the locked state of thepuncture handle 26 . At this time, the puncture handle 26 can be pushed to the distal end to drive thepuncture needle 24 to move to the distal end until thepuncture needle 24 passes through theleaflets 200 and forms a fixed connection with thefastener 64 of thesuture 60, as shown in FIG. 30 .

第七步，参见图31和图32，后撤穿刺手柄26，使得穿刺针头24带动缝合线60的固定件64、与固定件64相连的缝合线主体62依次穿过瓣叶200。The seventh step, referring to FIGS. 31 and 32 , withdraw the puncture handle 26 so that thepuncture needle 24 drives the fixingmember 64 of thesuture 60 and thesuture body 62 connected to the fixingmember 64 to pass through thevalve leaflet 200 in sequence.

第八步，继续后撤穿刺手柄26直至固定件64自推送手柄34的近端撤出，然后后撤操纵件464，带动夹持辅助件44回撤至辅助臂收容腔328中，撤出整个瓣膜缝合器100，并调整留在心脏内的缝合线主体62的长度，将缝合线主体62的两端分别固定在心室壁上，完成缝合线60植入(如图33所示)。The eighth step, continue to withdraw the puncture handle 26 until the fixingmember 64 is withdrawn from the proximal end of the push handle 34, and then withdraw the operatingmember 464 to drive the clampingauxiliary member 44 to withdraw into the auxiliaryarm receiving cavity 328, and withdraw the entire Thevalve stapler 100 is installed, and the length of the suturemain body 62 left in the heart is adjusted, and the two ends of the suturemain body 62 are respectively fixed on the ventricular wall to complete the implantation of the suture wire 60 (as shown in FIG. 33 ).

以上，仅是本申请的较佳实施方式而已，并非对本申请作任何形式上的限制。虽然本申请已以较佳实施方式揭露如上，然而并非用以限定本申请。任何熟悉本领域的技术人员，在不脱离本申请技术方案范围情况下，都可利用上述揭示的方法和技术内容对本申请技术方案做出许多可能的变动和修饰，或修改为等同变化的等效实施方式。因此，凡是未脱离本申请技术方案的内容，依据本申请的技术实质对以上实施方式所做的任何简单修改、等同变化及修饰，均仍属于本申请技术方案保护的范围内。The above are only preferred embodiments of the present application, and do not limit the present application in any form. Although the present application has been disclosed above in preferred embodiments, it is not intended to limit the present application. Any person skilled in the art, without departing from the scope of the technical solution of the present application, can use the methods and technical contents disclosed above to make many possible changes and modifications to the technical solution of the present application, or be modified into equivalents of equivalent changes. implementation. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments according to the technical essence of the present application without departing from the content of the technical solutions of the present application still fall within the protection scope of the technical solutions of the present application.

Claims (15)

Translated fromChinese

1.一种瓣膜缝合器，其特征在于，包括：1. a valve stapler, is characterized in that, comprises:推送装置，所述推送装置包括推送导管；和a pusher comprising a pusher conduit; and夹持装置，所述夹持装置包括夹持推杆、近端夹头、远端夹头、夹持操作机构及弹性机构，所述夹持推杆活动地穿装在所述推送导管中，所述近端夹头设于所述推送导管的远端，所述远端夹头设于所述夹持推杆的远端，所述弹性机构固定连接所述夹持推杆的近端，所述夹持操作机构活动连接所述夹持推杆的近端及所述弹性机构，所述夹持操作机构带动所述夹持推杆由远端向近端移动使所述远端夹头与所述近端夹头闭合后，所述夹持操作机构压缩所述弹性机构，使所述夹持操作机构相对于所述夹持推杆向近端发生位移以发出声音反馈。A clamping device, the clamping device includes a clamping push rod, a proximal end collet, a distal end clamp, a clamping operation mechanism and an elastic mechanism, the clamping push rod is movably inserted into the pushing catheter, The proximal end collet is arranged at the distal end of the pushing catheter, the distal end collet is arranged at the distal end of the clamping push rod, and the elastic mechanism is fixedly connected to the proximal end of the clamping push rod, The clamping operation mechanism movably connects the proximal end of the clamping push rod and the elastic mechanism, and the clamping operation mechanism drives the clamping push rod to move from the distal end to the proximal end to make the distal end chuck After being closed with the proximal collet, the clamping operating mechanism compresses the elastic mechanism, so that the clamping operating mechanism is displaced towards the proximal end relative to the clamping push rod to give sound feedback.2.根据权利要求1所述的瓣膜缝合器，其特征在于，所述瓣膜缝合器还包括设于所述推送导管近端的推送手柄，所述夹持操作机构设于所述推送手柄，所述弹性机构包括第一连接件和弹性元件，所述第一连接件与所述夹持操作机构活动连接，所述第一连接件的远端与所述夹持推杆的近端固定连接，所述夹持推杆的近端抵持所述夹持操作机构，所述弹性元件套设于所述第一连接件外并位于所述第一连接件的近端与所述夹持操作机构之间。2. The valve stapler according to claim 1, wherein the valve stapler further comprises a push handle provided at the proximal end of the push catheter, and the clamping operating mechanism is provided on the push handle, so The elastic mechanism includes a first connecting piece and an elastic element, the first connecting piece is movably connected with the clamping operating mechanism, and the distal end of the first connecting piece is fixedly connected with the proximal end of the clamping push rod, The proximal end of the clamping push rod abuts the clamping operation mechanism, and the elastic element is sleeved outside the first connecting piece and is located between the proximal end of the first connecting piece and the clamping operation mechanism between.3.根据权利要求2所述的瓣膜缝合器，其特征在于，所述第一连接件包括主体及设于所述主体近端的凸沿，所述主体活动穿设于所述夹持操作机构中，所述主体的远端与所述夹持推杆的近端固定连接，所述弹性元件套设于所述主体外，所述弹性元件位于所述凸沿与所述夹持操作机构之间。3 . The valve stapler according to claim 2 , wherein the first connecting member comprises a main body and a protruding edge disposed at the proximal end of the main body, and the main body is movably passed through the clamping operating mechanism. 4 . , the distal end of the main body is fixedly connected with the proximal end of the clamping push rod, the elastic element is sleeved outside the main body, and the elastic element is located between the convex edge and the clamping operation mechanism between.4.根据权利要求3所述的瓣膜缝合器，其特征在于，所述弹性机构还包括第二连接件，所述第二连接件固定连接于所述主体的远端与所述夹持推杆的近端之间。4 . The valve stapler according to claim 3 , wherein the elastic mechanism further comprises a second connecting piece, and the second connecting piece is fixedly connected to the distal end of the main body and the clamping push rod. 5 . between the proximal ends.5.根据权利要求1所述的瓣膜缝合器，其特征在于，所述瓣膜缝合器还包括设于所述推送导管近端的推送手柄，所述夹持操作机构设于所述推送手柄，所述推送手柄的内表面设有挡板，所述弹性机构包括第一连接件，所述第一连接件与所述夹持操作机构活动连接，所述第一连接件包括弹性部和连接部，所述弹性部的径向尺寸大于所述连接部的径向尺寸，所述连接部与所述夹持推杆的近端固定连接，所述夹持推杆的近端抵持所述夹持操作机构，所述弹性部的两端分别抵持所述夹持操作机构和所述挡板。5. The valve stapler according to claim 1, wherein the valve stapler further comprises a push handle provided at the proximal end of the push catheter, and the clamping operating mechanism is provided on the push handle, so The inner surface of the push handle is provided with a baffle plate, the elastic mechanism includes a first connecting piece, the first connecting piece is movably connected with the clamping operation mechanism, and the first connecting piece includes an elastic part and a connecting part, The radial dimension of the elastic part is larger than the radial dimension of the connecting part, the connecting part is fixedly connected with the proximal end of the clamping push rod, and the proximal end of the clamping push rod abuts the clamping An operating mechanism, two ends of the elastic portion respectively abut against the clamping operating mechanism and the baffle plate.6.根据权利要求1所述的瓣膜缝合器，其特征在于，所述瓣膜缝合器还包括设于所述推送导管近端的推送手柄，所述夹持操作机构设于所述推送手柄，所述推送手柄的内表面沿轴向设有滑移槽，所述夹持操作机构包括连接的滑移件与操作组件，所述滑移件滑动设于所述滑移槽中，所述弹性机构与所述滑移件活动连接，所述弹性机构与所述夹持推杆的近端固定连接，所述夹持推杆的近端抵持所述滑移件，所述操作组件驱动所述滑移件沿所述滑移槽轴向滑动。6. The valve stapler according to claim 1, wherein the valve stapler further comprises a push handle provided at the proximal end of the push catheter, and the clamping operating mechanism is provided on the push handle, so The inner surface of the push handle is provided with a sliding groove along the axial direction, the clamping operation mechanism includes a connected sliding member and an operating assembly, the sliding member is slidably arranged in the sliding groove, and the elastic mechanism Actively connected with the sliding member, the elastic mechanism is fixedly connected with the proximal end of the clamping push rod, the proximal end of the clamping push rod abuts the sliding member, and the operating assembly drives the The sliding member slides axially along the sliding groove.7.根据权利要求6所述的瓣膜缝合器，其特征在于，所述操作组件与所述滑移件弹性连接，所述推送手柄的内表面还设有导向槽，所述操作组件滑动设于所述导向槽中，所述导向槽包括相连的径向导向槽及轴向导向槽，所述轴向导向槽相较于所述径向导向槽更靠近所述推送手柄的中轴线，所述操作组件可在自然状态与压缩状态之间转换，所述操作组件由所述轴向导向槽移动到所述径向导向槽时，所述操作组件由所述压缩状态转换为所述自然状态而冲击所述推送手柄以产生声音反馈。7. The valve stapler according to claim 6, wherein the operating assembly is elastically connected with the sliding member, the inner surface of the push handle is further provided with a guide groove, and the operating assembly is slidably arranged on Among the guide grooves, the guide groove includes a connected radial guide groove and an axial guide groove, the axial guide groove is closer to the central axis of the push handle than the radial guide groove, and the The operating assembly can be converted between a natural state and a compressed state, and when the operating assembly is moved from the axial guide slot to the radial guide groove, the operating assembly is converted from the compressed state to the natural state and Shock the push handle to generate audible feedback.8.根据权利要求7所述的瓣膜缝合器，其特征在于，所述推送手柄的侧面还设有操作通槽，所述操作组件包括滑动板、操作件及弹性件，所述滑动板连接所述操作件，所述滑动板滑动设于所述导向槽中，所述操作件卡设于所述操作通槽并露出所述推送手柄外，所述弹性件连接于所述滑移件与所述滑动板之间，在所述弹性件由所述压缩状态转换为所述自然状态时，所述操作件冲击所述推送手柄以产生声音反馈。8 . The valve stapler according to claim 7 , wherein an operating through groove is further provided on the side of the push handle, and the operating assembly comprises a sliding plate, an operating member and an elastic member, and the sliding plate is connected to the For the operating member, the sliding plate is slidably arranged in the guide groove, the operating member is clamped in the operating through groove and exposed outside the push handle, and the elastic member is connected to the sliding member and the Between the sliding plates, when the elastic member is converted from the compressed state to the natural state, the operating member impacts the push handle to generate sound feedback.9.根据权利要求8所述的瓣膜缝合器，其特征在于，所述操作件包括依次连接的操作部、连接部及反馈部，所述连接部穿设于所述操作通槽，所述操作部位于所述推送手柄外，所述反馈部收容于所述推送手柄的内腔中，在所述弹性件由所述压缩状态转换为所述自然状态时，所述反馈部冲击所述推送手柄的内侧面以产生声音反馈。9 . The valve stapler according to claim 8 , wherein the operating member comprises an operating part, a connecting part and a feedback part connected in sequence, the connecting part is penetrated through the operating through groove, and the operating part The feedback part is located outside the push handle, the feedback part is accommodated in the inner cavity of the push handle, and when the elastic member is converted from the compressed state to the natural state, the feedback part impacts the push handle the inner side to generate audible feedback.10.根据权利要求8所述的瓣膜缝合器，其特征在于，所述夹持操作机构还包括安装杆，所述安装杆连接于所述滑移件与所述操作件之间，所述弹性件套设于所述安装杆外。10. The valve stapler according to claim 8, wherein the clamping operation mechanism further comprises a mounting rod, the mounting rod is connected between the sliding member and the operating member, and the elastic The piece is sleeved outside the installation rod.11.根据权利要求1所述的瓣膜缝合器，其特征在于，所述推送装置还包括连通所述推送导管的密封管，所述密封管位于所述推送手柄的内腔中并与所述推送导管的近端连接，所述夹持推杆活动穿装在所述密封管中。11. The valve stapler according to claim 1, wherein the pushing device further comprises a sealing tube communicating with the pushing catheter, the sealing tube is located in the inner cavity of the pushing handle and is connected with the pushing The proximal end of the catheter is connected, and the clamping push rod is movably inserted into the sealing tube.12.根据权利要求11所述的瓣膜缝合器，其特征在于，所述密封管的远端与所述推送导管的近端连通，所述密封管的近端开口且填充至少一个密封件，所述密封件设有通孔以供所述夹持推杆穿过。12. The valve stapler according to claim 11, wherein the distal end of the sealing tube communicates with the proximal end of the pushing catheter, the proximal end of the sealing tube is open and filled with at least one sealing member, so The sealing member is provided with a through hole for the clamping push rod to pass through.13.根据权利要求1所述的瓣膜缝合器，其特征在于，所述瓣膜缝合器还包括穿刺装置，所述穿刺装置活动地穿装在所述推送导管中，所述穿刺装置包括穿刺推杆及设于所述穿刺推杆远端的穿刺针头。13. The valve stapler according to claim 1, characterized in that, the valve stapler further comprises a puncture device, the puncture device is movably inserted into the push catheter, and the puncture device comprises a puncture push rod and a puncture needle arranged at the distal end of the puncture push rod.14.根据权利要求1所述的瓣膜缝合器，其特征在于，所述瓣膜缝合器还包括探测装置，所述探测装置包括至少一个探针，所述探针活动地穿装在所述推送导管中,所述近端夹头的夹持面设有探针出口，所述远端夹头的夹持面设有与所述探针出口相对的探针收容腔，所述远端夹头与所述近端夹头闭合时，所述探针的远端自所述探针出口伸出收容于所述探针收容腔中。14. The valve stapler according to claim 1, characterized in that, the valve stapler further comprises a detection device, the detection device comprises at least one probe, and the probe is movably worn on the push catheter , the clamping surface of the proximal collet is provided with a probe outlet, the clamping surface of the distal collet is provided with a probe accommodating cavity opposite to the probe outlet, and the distal collet is connected with the probe outlet. When the proximal collet is closed, the distal end of the probe protrudes from the probe outlet and is accommodated in the probe accommodating cavity.15.根据权利要求1所述的瓣膜缝合器，其特征在于，所述瓣膜缝合器还包括夹持辅助装置，所述夹持辅助装置包括至少一个夹持辅助臂及设于所述夹持辅助臂远端的夹持辅助件，所述夹持辅助臂活动地穿装在所述推送导管中，所述夹持辅助件由弹性和/或柔性材料制成，所述夹持辅助臂推动与其相连的所述夹持辅助件从所述推送导管远端或所述夹持装置远端穿出，所述夹持辅助件与所述夹持装置配合夹持瓣叶。15. The valve stapler according to claim 1, characterized in that, the valve stapler further comprises a clamping auxiliary device, and the clamping auxiliary device comprises at least one clamping auxiliary arm and a clamping auxiliary arm provided on the clamping auxiliary device. a gripping aid at the distal end of the arm, the gripping aid arm being movably fitted in the push conduit, the gripping aid being made of elastic and/or flexible material, the gripping aid arm pushing against it The connected clamping aids are protruded from the distal end of the pushing catheter or the distal end of the clamping device, and the clamping aids cooperate with the clamping device to clamp the valve leaflets.

Images