WO2021143622A1 - Tissue clipping device and use method therefor - Google Patents

Abstract

A tissue clipping device and a use method therefor, comprising a handle, an inner tube, an inner clip, an outer tube base, an outer tube, a sleeve, an outer clip, and a release mechanism. The outer tube is connected to the sleeve and the outer tube base; the outer clip is provided with an outer clip base and outer clip pieces, and clipping of the outer clip pieces is driven by a sleeve opening; the inner tube penetrates through the outer tube base, the outer tube, and the sleeve, sequentially, the outer clip base is sleeved in the outer tube, and the inner tube is connected to the inner clip and the handle; the inner clip is provided with an inner clip base and inner clip pieces, and the inner clip base abuts against the outer clip base to drive the outer clip base to move, and the inner clip pieces abut against the outer clip pieces to be combined into a clip; the release mechanism is sleeved at a position where a front end of the outer tube and the sleeve are connected, and is used for locking or unlocking the connection between the outer tube and the sleeve. By means of the tissue clipping device and the use method therefor in the present invention, the operation can be performed more conveniently, accurately, and safely, and operation requirements for a doctor are reduced. Moreover, if a mitral valve leaflet clipping position is not good, repeated clipping and release can be performed.

Description

Translated fromChinese

一种用于组织夹合的装置及其使用方法Device for tissue clamping and its use method技术领域Technical field

本发明属于医疗器械技术领域，具体涉及一种用于组织夹合的装置及其使用方法。The invention belongs to the technical field of medical devices, and specifically relates to a device for tissue clamping and a method of use thereof.

背景技术Background technique

心脏瓣膜病是我国最常见的心脏病之一，其中主要为风湿热导致的瓣膜损害；近年来随着人口老龄化的发展，瓣膜退行性变(包括钙化和粘液变性等)以及代谢障碍性瓣膜损害在我国也日益增多。二尖瓣反流的特征是血液通过机能不健全的二尖瓣从心脏的左心室到左心房的逆行流动。在正常的心脏收缩周期期间，二尖瓣作为止回阀，防止含氧血液回流进左心房，如此，含氧血液通过主动脉瓣泵送到主动脉，然后至全身。二尖瓣反流会显著降低心脏的泵送效率，从而将患者置于严重的、渐进的心脏衰竭风险。最常见的二尖瓣反流治疗依赖瓣膜置换或修复，包括瓣叶和环重塑，后者一般称为瓣膜成形术。尽管所有这些技术非常有效，但因为其依赖开胸，手术创伤大，患者恢复慢。近年来，国际上也出现了雅培公司的Mitraclip，一种通过经皮静脉介入的瓣膜钳夹装置，但其复杂的操作给医生带来了困扰。专利文献如公开号为CN107595435A的专利文献公开了一种瓣膜夹合器，包括第一夹合部件、第二夹合部件和连接部，所述第一夹合部件具有至少两个第一夹合臂，所述第二夹合部件具有相应数量的第二夹合臂，每个所述第一夹合臂同其相应的所述第二夹合臂可组合成为一组夹具，但其操作不便捷，释放不稳定，影响手术成功率。Heart valvular disease is one of the most common heart diseases in my country, among which valve damage is mainly caused by rheumatic fever; in recent years, with the development of the aging population, valve degeneration (including calcification and mucous degeneration) and metabolic disorders valves Damage is also increasing in our country. The characteristic of mitral regurgitation is the retrograde flow of blood from the left ventricle of the heart to the left atrium through the malfunctioning mitral valve. During the normal systolic cycle, the mitral valve acts as a check valve to prevent oxygenated blood from flowing back into the left atrium, so that oxygenated blood is pumped through the aortic valve to the aorta and then to the whole body. Mitral regurgitation can significantly reduce the pumping efficiency of the heart, thereby putting the patient at severe and progressive risk of heart failure. The most common treatment of mitral regurgitation relies on valve replacement or repair, including leaflet and annulus remodeling, the latter of which is generally called valvuloplasty. Although all these techniques are very effective, because they rely on thoracotomy, the surgical trauma is large and the patient recovers slowly. In recent years, Abbott’s Mitraclip, a valve clamping device through percutaneous venous intervention, has also appeared internationally, but its complicated operation has brought trouble to doctors. Patent documents such as the patent document with publication number CN107595435A disclose a valve clamp, including a first clamping part, a second clamping part, and a connecting part. The first clamping part has at least two first clamping parts. The second clamping member has a corresponding number of second clamping arms, and each of the first clamping arms and its corresponding second clamping arm can be combined into a set of clamps, but its operation is not Convenient and unstable release, which affects the success rate of surgery.

针对现有相关技术的上述缺点，需要一种新的装置系统和方法。In view of the above-mentioned shortcomings of the existing related technologies, a new device system and method is needed.

发明内容Summary of the invention

基于现有技术中存在的上述不足，本发明提供一种用于组织夹合的装置及 其使用方法。Based on the above-mentioned shortcomings in the prior art, the present invention provides a device for tissue splicing and a method of use thereof.

为了达到上述发明目的，本发明采用以下技术方案：In order to achieve the above-mentioned purpose of the invention, the present invention adopts the following technical solutions:

一种用于组织夹合的装置，包括手柄、内管、内夹、外管座、外管、套管、外夹、释放机构；所述外管前端与套管连接，后端与外管座连接；所述外夹具有外夹座及两片位于外夹座上呈开口状的外夹片，所述外夹座套设于套管内且两片外夹片漏出于套管口一端，以使外夹座可以在套管内沿套管方向活动，由套管口带动外夹片夹合；所述内管依次贯穿外管座、外管、套管、外夹座套设于外管内，所述内管前端与内夹连接，后端与手柄连接，以使手柄依次带动内管、内夹沿外管方向在外管内活动；所述内夹具有内夹座及两片位于内夹座上呈开口状的内夹片，所述内夹座具有抵靠凸起，以使内夹座抵触外夹座时带动外夹座活动，所述内夹片与外夹片相适配，以使内夹片与外夹片抵触时组合为夹具；所述释放机构套设于外管前端与套管连接处，用于锁定或解锁外管与套管的连接。A device for tissue clamping, including a handle, an inner tube, an inner clamp, an outer tube seat, an outer tube, a sleeve, an outer clamp, and a release mechanism; the front end of the outer tube is connected with the sleeve, and the rear end is connected with the outer tube Seat connection; the outer clip has an outer clip seat and two open-shaped outer clips located on the outer clip seat, the outer clip seat is sleeved in the casing and the two outer clips leak out of one end of the casing mouth, So that the outer clamp seat can move in the casing along the direction of the sleeve, the outer clamp is driven by the sleeve mouth to clamp; the inner tube passes through the outer tube seat, the outer tube, the sleeve, and the outer clamp seat is sleeved in the outer tube in turn , The front end of the inner tube is connected with the inner clip, and the rear end is connected with the handle, so that the handle drives the inner tube and the inner clip to move in the outer tube along the direction of the outer tube in turn; the inner clip has an inner clip seat and two pieces located on the inner clip seat The upper is an open-shaped inner clip, the inner clip seat has abutting protrusions, so that when the inner clip seat is in contact with the outer clip seat, the outer clip seat is driven to move, and the inner clip is matched with the outer clip. The inner clip piece and the outer clip piece are combined to form a clamp when they are in conflict; the release mechanism is sleeved at the connection between the front end of the outer tube and the sleeve, and is used to lock or unlock the connection between the outer tube and the sleeve.

作为优选方案，所述释放机构包括释放管、释放管座，所述释放管前端具有内腔和凸台，所述套管嵌设于内腔且外侧设有带凹槽凸壁，所述带凹槽凸壁与凸台相适配以形成旋转卡接结构；所述释放管座一端与释放管后端连接，用于旋转释放管。As a preferred solution, the release mechanism includes a release tube and a release tube seat, the front end of the release tube has an inner cavity and a boss, the sleeve is embedded in the inner cavity and the outer side is provided with a grooved convex wall, the belt The groove convex wall is matched with the boss to form a rotating clamping structure; one end of the release pipe seat is connected with the rear end of the release pipe for rotating the release pipe.

作为优选方案，所述释放管座上还设有排空口，用于手术排空，所述释放管座另一端设有密封件；所述外管座尾端设有鲁尔接口。As a preferred solution, the release tube socket is further provided with an emptying port for surgical emptying, the other end of the release tube socket is provided with a sealing element; the end of the outer tube socket is provided with a luer interface.

作为优选方案，所述内管直径为0.5-2.5mm，所述外管直径为2.6-5mm，所述两片外夹片开口角度为100-160度。As a preferred solution, the diameter of the inner tube is 0.5-2.5 mm, the diameter of the outer tube is 2.6-5 mm, and the opening angle of the two outer clips is 100-160 degrees.

作为优选方案，所述套管管直径小于外管直径以使套管插接入外管，所述外管内部具有限位台阶，所述限位台阶用于抵靠套管底部。As a preferred solution, the diameter of the casing tube is smaller than the diameter of the outer tube so that the casing can be inserted into the outer tube, and the outer tube has a limiting step inside, and the limiting step is used to abut the bottom of the casing.

作为优选方案，所述外管前端还具有限位凹槽，所述套管具有限位凸起，所述限位凹槽与限位凸起相适配限制套管沿外管周向活动。As a preferred solution, the front end of the outer tube further has a limiting groove, the sleeve has a limiting protrusion, and the limiting groove and the limiting protrusion are matched to restrict the sleeve from moving in the circumferential direction of the outer tube.

作为优选方案，所述套管的套管壁上设有若干孔洞，用于加速套管植入内 皮化。As a preferred solution, a number of holes are provided on the sleeve wall of the sleeve for accelerating endothelialization of the sleeve implantation.

作为优选方案，所述内夹片和外夹片抵触面侧分别设有夹齿，所述外夹片外侧底端还设有卡接凸起。As a preferred solution, the abutting surface sides of the inner clip and the outer clip are respectively provided with clamping teeth, and the outer bottom end of the outer clip is also provided with a clamping protrusion.

作为优选方案，所述套管内腔管口端部设有内螺纹，所述外夹座外侧设有与内螺纹相适配的外螺纹。As a preferred solution, the end of the mouth of the inner cavity of the sleeve is provided with an internal thread, and the outer side of the outer clamp seat is provided with an external thread adapted to the internal thread.

一种用于组织夹合的装置使用方法，通过一种用于组织夹合的装置实现，包括如下步骤：A method for using a device for tissue clamping is implemented by a device for tissue clamping, and includes the following steps:

S1.将用于组织夹合的装置送至心脏瓣膜处，通过手柄控制内管前后移动，调节内夹的位置，使外夹片和内夹片位置分别位于脱垂的瓣叶内外两侧；S1. Send the device for tissue clamping to the heart valve, control the inner tube to move back and forth through the handle, and adjust the position of the inner clip so that the positions of the outer clip and the inner clip are located on the inner and outer sides of the prolapsed valve leaflet;

S2.抽动手柄将内夹和外夹收入到套管内，夹合瓣膜；S2. Twitch the handle to collect the inner clip and the outer clip into the sleeve and clamp the valve;

S3.解开内管和内夹的连接，调整释放机构，解锁外管与套管的连接，释放套管及内外夹。S3. Unlock the connection between the inner tube and the inner clamp, adjust the release mechanism, unlock the connection between the outer tube and the sleeve, and release the sleeve and the inner and outer clamps.

本发明与现有技术相比，有益效果是：Compared with the prior art, the present invention has the following beneficial effects:

本发明的一种用于组织夹合的装置及其使用方法能更加方便准确和安全地进行操作，降低了对医者的操作要求。同时，如果二尖瓣瓣叶夹合位置不佳时，可重复夹合，再操作释放。The device for tissue clamping and its use method of the present invention can be operated more conveniently, accurately and safely, and the operation requirements for doctors are reduced. At the same time, if the clamping position of the mitral valve leaflets is not good, the clamping can be repeated, and then the operation is released.

附图说明Description of the drawings

图1是本发明实施例一的用于组织夹合的装置的整体结构示意图；Figure 1 is a schematic diagram of the overall structure of the device for tissue clamping according to the first embodiment of the present invention;

图2是本发明实施例一的用于组织夹合的装置的整体剖面结构示意；2 is a schematic diagram of the overall cross-sectional structure of the device for tissue splicing according to the first embodiment of the present invention;

图3是本发明实施例一的用于组织夹合的装置的手术中使用状态示意图；Fig. 3 is a schematic diagram of the operating state of the device for tissue clamping according to the first embodiment of the present invention;

图4是本发明实施例一的用于组织夹合的装置的内外夹释放后示意图；4 is a schematic diagram of the internal and external clamps of the device for tissue clamping according to the first embodiment of the present invention after being released;

图5是本发明实施例一的用于组织夹合的装置的外管结构示意图；Fig. 5 is a schematic diagram of the outer tube structure of the device for tissue splicing according to the first embodiment of the present invention;

图6是本发明实施例一的用于组织夹合的装置的释放管剖面结构示意图；6 is a schematic diagram of a cross-sectional structure of the release tube of the device for tissue clamping according to the first embodiment of the present invention;

图7是本发明实施例一的用于组织夹合的装置的套管结构示意图；Figure 7 is a schematic diagram of the sleeve structure of the device for tissue clamping according to the first embodiment of the present invention;

图8是本发明实施例一的用于组织夹合的装置的外夹部分瓣叶闭合时结 构示意图；Fig. 8 is a schematic structural view of the valve leaflets of the outer clamping part of the device for tissue clamping according to the first embodiment of the present invention;

图9是本发明实施例一的用于组织夹合的装置的内夹部分瓣叶闭合时结构示意图；9 is a schematic structural view of the valve leaflets of the inner clamping part of the device for tissue clamping according to the first embodiment of the present invention;

其中：1.手柄；2.内管；3.外管座；4.外管；401.限位凹槽；402.限位台阶；5.释放管密封件；6.释放管座；7.释放管；701.凸台；702.内腔；8.套管；801.限位凸起；802.带凹槽凸壁；803.孔洞；9.外夹；901.外夹片；902.外夹座；10.内夹；101.内夹片；102.内夹座。Among them: 1. Handle; 2. Inner tube; 3. Outer tube seat; 4. Outer tube; 401. Limit groove; 402. Limit step; 5. Release tube seal; 6. Release tube seat; 7. Release tube; 701. Boss; 702. Inner cavity; 8. Casing; 801. Limiting protrusion; 802. Convex wall with groove; 803. Hole; 9. Outer clip; 901. Outer clip; 902. Outer clamp seat; 10. Inner clamp; 101. Inner clamp piece; 102. Inner clamp seat.

具体实施方式Detailed ways

为了更清楚地说明本发明实施例，下面将对照附图说明本发明的具体实施方式。显而易见地，下面描述中的附图仅仅是本发明的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图，并获得其他的实施方式。In order to explain the embodiments of the present invention more clearly, the specific embodiments of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings in the following description are only embodiments of the present invention. For those of ordinary skill in the art, without creative work, other drawings can be obtained based on these drawings, and others can be obtained.的实施方式。

实施例一：Example one:

如图1-9所示，本实施例的一种用于组织夹合的装置系统和方法，其装置包括手柄1、内管2、外管座3、外管4、释放机构、套管8、外夹9、内夹10。内管2前段与内夹10相连，后端与手柄1相连。外管4前段与套管8相连，后端与外管座3相连，释放管7前段内腔702有凸台701，将套管8固定在外管4上，释放机构释放，套管8才可从外管4上脱落。通过手柄1控制内管2前后移动，调节内夹10的位置，使其夹合脱垂的瓣叶，如若位置不合适，还可重复调整，合适后，将内夹10和外夹9收入到套管8内，解开内管2和内夹10的连接，然后调整释放机构，释放套管8及内外夹9，完成快速稳定的操作，操作简单便捷。As shown in Figures 1-9, a device system and method for tissue clamping of this embodiment includes ahandle 1, aninner tube 2, anouter tube seat 3, anouter tube 4, a release mechanism, and asleeve 8 ,Outer clip 9,inner clip 10. The front section of theinner tube 2 is connected with theinner clip 10, and the rear end is connected with thehandle 1. The front section of theouter tube 4 is connected with thesleeve 8, and the rear end is connected with theouter tube socket 3. Theinner cavity 702 of the front section of therelease tube 7 has aboss 701. Thesleeve 8 is fixed on theouter tube 4, and the release mechanism is released. Fall off from theouter tube 4. Control theinner tube 2 to move back and forth through thehandle 1, adjust the position of theinner clip 10 to clamp the prolapsed valve leaflet. If the position is not suitable, you can repeat the adjustment. When appropriate, theinner clip 10 and theouter clip 9 are collected. Inside thecasing 8, untie the connection between theinner tube 2 and theinner clip 10, and then adjust the release mechanism to release thecasing 8 and the inner andouter clips 9 to complete a quick and stable operation, which is simple and convenient.

具体的，外管4前端与套管8连接，后端与外管座3通过螺纹连接或胶粘固定等方式连接，套管8管直径小于外管4直径以使套管8插接入外管4，外管4内部具有限位台阶402，限位台阶402抵靠住套管8底部，外管4前端还 具有限位凹槽401，套管8具有限位凸起801，限位凹槽401与限位凸起801相适配限制套管8沿外管4周向活动；外夹9具有外夹座902及两片位于外夹座902上呈开口状的外夹片901，外夹座902套设于套管8内且两片外夹片901漏出于套管8口一端，以使外夹座902可以在套管8内沿套管8方向活动，由套管8口带动外加片夹合，套管8内腔管口端部设有内螺纹，外夹座902外侧设有与内螺纹相适配的外螺纹，在装置未使用状态下，可以先将外夹座902螺入套管8螺纹处避免外夹座902任意活动，外夹片901外侧底端还设有卡接凸起，闭合外夹片901时，卡接凸起卡接在套管8口内腔端口处，稳固夹合动作；内管2依次贯穿外管座3、外管4、套管8、外夹座902套设于外管4内，内管2前端与内夹座102通过螺纹连接，后端与手柄1通过螺纹连接或胶粘固定等方式连接，以使手柄1依次带动内管2、内夹10沿外管4方向在外管4内活动；内夹10具有内夹座102及两片位于内夹座102上呈开口状的内夹片101，内夹座102具有抵靠凸起，以使内夹座102抵触外夹座902时带动外夹座902沿套管8管向活动，外夹座902内还设有方形、三角形、异形等非圆形的凹槽，抵靠凸起前端插入凹槽端形状与凹槽相适配，使内夹座102还能带动外夹座902沿套管8周向旋转活动；内夹片101与外夹片901相适配，使内夹片101与外夹片901抵触时组合为夹具，且内夹片101和外夹片901都呈弧形，抵触面侧分别设有倒刺状夹齿，加强夹持力；释放机构套设于外管4前端与套管8连接处，用于锁定或解锁外管4与套管8的连接，释放机构包括释放管7、释放管座6，释放管7前端具有内腔702和凸台701，套管8嵌设于内腔702且外侧设有带凹槽凸壁802，带凹槽凸壁802与凸台701相适配以形成旋转卡接结构，具体的，凸台701可以穿过带凹槽凸壁802的凹槽并在凹壁处旋转活动卡在凸壁处，当凸台701再次旋转到和凹槽重合的位置时，可以穿出凹槽脱离卡接；释放管座6一端与释放管7后端通过螺纹连接或胶粘固定连接，用于手持旋转释放管座6带动释放管7旋转；释放管座6上还设有排空口，用于手术排空，释放管座6另一端设有密封件，密封件可以为密封螺 钉、密封垫等等可以加强排空密封性的器件，当然释放机构还可以是两个半圆相互夹合的夹片，夹片底端可以张开释放解锁套管8和外管4的连接、或者套管8具有L形凹槽、释放管7具有与L形凹槽适配的凸起旋转卡接完成锁定或解锁等等，不限制释放机构的具体结构；外管座3尾端以鲁尔接口标准螺纹设计，可方便连接标准鲁尔接口器械，增强功能性。Specifically, the front end of theouter tube 4 is connected with thesleeve 8, and the rear end is connected with theouter tube base 3 by threaded connection or adhesive fixation. The diameter of thesleeve 8 is smaller than the diameter of theouter tube 4 so that thesleeve 8 can be inserted into the outer tube.Tube 4, theouter tube 4 has a limitingstep 402 inside, the limitingstep 402 abuts the bottom of thesleeve 8, the front end of theouter tube 4 also has a limitinggroove 401, thesleeve 8 has a limitingprotrusion 801, a limiting recess Thegroove 401 is matched with the limitingprotrusion 801 to restrict thesleeve 8 from moving in the circumferential direction of theouter tube 4; theouter clamp 9 has anouter clamp seat 902 and twoouter clamp pieces 901 which are open on theouter clamp seat 902, Theclamp seat 902 is sleeved in thesleeve 8 and the twoouter clamp pieces 901 leak out from one end of thesleeve 8 port, so that theouter clamp seat 902 can move in thesleeve 8 along the direction of thesleeve 8 and is driven by thesleeve 8 port. The external clamp is clamped, the end of the inner cavity of thesleeve 8 is provided with internal threads, and the outside of theouter clamp seat 902 is provided with external threads that match the internal threads. When the device is not in use, theouter clamp seat 902 can be clamped first. Screw into the thread of thesleeve 8 to avoid arbitrary movement of theouter clamp seat 902. The outer bottom end of theouter clamp 901 is also provided with a clamping protrusion. When theouter clamp 901 is closed, the clamping protrusion is clamped on the inner cavity port of thesleeve 8 Theinner tube 2 penetrates through theouter tube socket 3, theouter tube 4, thesleeve 8, and theouter clamp seat 902 in sequence, and is sleeved in theouter tube 4, and the front end of theinner tube 2 is connected with theinner clamp seat 102 through threads. The rear end and thehandle 1 are connected by threaded connection or adhesive fixation, so that thehandle 1 drives theinner tube 2 and theinner clip 10 to move in theouter tube 4 along the direction of theouter tube 4; theinner clip 10 has aninner clip seat 102 and two Theinner clip 101 is located on theinner clip seat 102 in an open shape. Theinner clip seat 102 has abutting protrusions so that when theinner clip seat 102 is in contact with theouter clip seat 902, theouter clip seat 902 is driven to move along the tube direction of thesleeve 8 , Theouter clamp seat 902 is also provided with non-circular grooves such as square, triangle, special-shaped, etc., and the shape of the groove end is inserted into the groove against the front end of the protrusion to match the groove, so that theinner clamp seat 102 can also drive theouter clamp seat 902 rotates along the circumferential direction of thesleeve 8; theinner clip 101 is adapted to theouter clip 901, so that theinner clip 101 and theouter clip 901 are combined to form a fixture when theinner clip 101 and theouter clip 901 collide, and theinner clip 101 and theouter clip 901 are both It is arc-shaped, and the side of the contact surface is respectively provided with barbed gripping teeth to strengthen the clamping force; the release mechanism is sleeved at the connection between the front end of theouter tube 4 and thesleeve 8 to lock or unlock theouter tube 4 and thesleeve 8 Connection, the release mechanism includes arelease tube 7, arelease tube seat 6. The front end of therelease tube 7 has aninner cavity 702 and aboss 701. Thesleeve 8 is embedded in theinner cavity 702 and the outer side is provided with a groovedconvex wall 802 with grooves. Theconvex wall 802 is adapted to theboss 701 to form a rotary clamping structure. Specifically, theboss 701 can pass through the groove of the groovedconvex wall 802 and rotate and move at the concave wall to be clamped at the convex wall. When the table 701 rotates to the position where it overlaps with the groove again, it can pass through the groove and detach from the clamping; one end of therelease pipe socket 6 is connected with the rear end of therelease pipe 7 by screwing or glueing, and is used to hold the rotatingrelease pipe socket 6 Drive therelease tube 7 to rotate; therelease tube seat 6 is also provided with an emptying port for surgical discharge The other end of therelease tube socket 6 is provided with a sealing element. The sealing element can be a sealing screw, a gasket, etc., which can enhance the drainage and sealing performance. Of course, the release mechanism can also be two semicircular clamps sandwiching each other. The bottom end of the sheet can be opened to release and unlock the connection between thesleeve 8 and theouter tube 4, or thesleeve 8 has an L-shaped groove, and therelease tube 7 has a protrusion that is adapted to the L-shaped groove to complete the locking or unlocking, etc. The specific structure of the release mechanism is not limited; the end of theouter tube base 3 is designed with a standard Luer interface thread, which can be easily connected to standard Luer interface devices and enhance functionality.

进一步的，手柄1选用高分子材料如PP、ABS、金属材料均可，结构不限，便于操作即可；内管2直径优选在0.5-2.5mm，外管4的材质，选用使用于手术操作的高分子材料(如PP、ABS、PE等)或不锈钢、镍钛等金属材料，直径在2.6-5mm。前端与内夹10以螺纹连接，后端与手柄1可以以正反螺纹、孔插入以铆钉固定，并可现场拆解；外管座3采用高分子材料，如PP、ABS等，释放管密封件5选用密封螺钉和释放管座6为一体配合器件，材质为高分子材料、金属材料，密封螺钉下增设密封垫，释放管7材质采用高分子材料和金属材料，如PP、ABS、PE和不锈钢等，套管8材质采用高分子材料、金属材料或者合金材料，套管8的限位凸起801可以为1个或多个，优选为2-3个，对应适配套管8限位凹槽401数量，限位凸起801和限位凹槽401位置可以互换，套管8插入到外管4的长度优选在1-3mm，套管8带凹槽凸壁802的为外环状，外环宽0.5-2mm，凹槽数量优选为2-3个，相适配释放管7凸台701数量，套管8壁上设有数量孔洞803，加速植入人体后内皮化进程；外夹9采用镍钛材质，两片夹片是圆弧形，经过热处理后，两片夹片的角度达到100-160度，便于捕获二尖瓣瓣叶；内夹10采用镍钛材质，两片夹片呈圆弧形，与外夹9相匹配，内夹10两片夹片前端上有一排倒刺状夹齿，在于外夹9夹合后，可刺入到瓣叶中，以防止内外夹9夹合瓣叶后脱落。Further, thehandle 1 can be made of polymer materials such as PP, ABS, and metal materials. The structure is not limited and easy to operate; the diameter of theinner tube 2 is preferably 0.5-2.5mm, and the material of theouter tube 4 is selected for use in surgical operations. High polymer materials (such as PP, ABS, PE, etc.) or metal materials such as stainless steel, nickel-titanium, etc., with a diameter of 2.6-5mm. The front end and theinner clamp 10 are connected by threads, the rear end and thehandle 1 can be fixed with positive and negative threads, holes are inserted with rivets, and can be disassembled on site; theouter tube base 3 is made of polymer materials, such as PP, ABS, etc., and the release tube is sealed Thepart 5 selects the sealing screw and therelease tube base 6 as an integrated device, the material is polymer material, metal material, and the sealing gasket is added under the sealing screw, and therelease tube 7 is made of polymer material and metal material, such as PP, ABS, PE and Stainless steel, etc. Thecasing 8 is made of polymer materials, metal materials or alloy materials. The limitingprotrusion 801 of thecasing 8 can be one or more, preferably 2-3, corresponding to the limit of the adaptingcasing 8. The number ofgrooves 401, the position of the limitingprotrusion 801 and the limitinggroove 401 can be interchanged, the length of thesleeve 8 inserted into theouter tube 4 is preferably 1-3mm, and thesleeve 8 with grooves andconvex walls 802 is the outer ring The outer ring is 0.5-2mm wide, the number of grooves is preferably 2-3, and the number ofbosses 701 of therelease tube 7 is adapted to the number ofholes 803 on the wall of thesleeve 8 to accelerate the endothelialization process after implantation in the human body; Theouter clip 9 is made of nickel-titanium material, and the two clips are arc-shaped. After heat treatment, the angle of the two clips reaches 100-160 degrees, which is convenient for capturing the mitral valve leaflets; theinner clip 10 is made of nickel-titanium material, two The clip piece is arc-shaped and matches theouter clip 9. There is a row of barbed teeth on the front ends of the two clips of theinner clip 10. After theouter clip 9 is clamped, it can penetrate into the valve leaflets to prevent The inner andouter clips 9 clamp the valve leaflets and fall off.

一种用于组织夹合的装置的使用方法，包括如下步骤：A method of using a device for tissue clamping includes the following steps:

S1.将用于组织夹合的装置送至心脏瓣膜处，比如：通过手术从心尖处将装置送入心室瓣膜处，通过手柄1控制内管2前后移动，调节内夹10的位置，使外夹片901和内夹片101位置分别位于脱垂的瓣叶内外两侧；S1. Send the device for tissue clamping to the heart valve, for example, send the device from the apex of the heart to the ventricular valve by surgery, control theinner tube 2 to move back and forth through thehandle 1, and adjust the position of theinner clip 10 to make the outer The position of theclip 901 and theinner clip 101 are respectively located on the inner and outer sides of the prolapsed valve leaflet;

S2.抽动手柄1将内夹10和外夹9收入到套管8内，夹合瓣膜；当然使用前先旋转手柄1依次带动内管2、内夹座102、外夹座902使外夹座902脱离套管8螺纹区，然后抽动手柄1依次带动内管2、内夹座102，内夹座102带动外夹座902收入套管8内，套管8口收合内夹10和外夹9从而夹合住待夹瓣叶，同时，如果二尖瓣瓣叶夹合位置不佳时，可重复夹合，最后将外夹片901外侧底端的卡接凸起卡入套管8口，稳固夹合动作；S2. Twitch thehandle 1 to collect theinner clip 10 and theouter clip 9 into thesleeve 8 to clamp the valve; of course, before use, rotate thehandle 1 to drive theinner tube 2, theinner clip seat 102, and theouter clip seat 902 in turn to make the outer clip seat. 902 separates from the threaded area of thecasing 8, and then pulls thehandle 1 to drive theinner tube 2 and theinner clamp seat 102 in turn, theinner clamp seat 102 drives theouter clamp seat 902 into thesleeve 8, and thesleeve 8 ports close theinner clamp 10 and theouter clamp 9 Thereby clamping the valve leaflets to be clamped, and at the same time, if the mitral valve leaflets are not well clamped, the clamping can be repeated, and finally the clamping protrusion on the outer bottom end of theouter clamping piece 901 is clamped into the 8 port of the sleeve. Firm clamping action;

S3.通过旋转手柄1带动内管2旋转，解开内管2和内夹10的螺纹连接，调整释放机构，即旋转释放管座6带动释放管7旋转，当释放管7的凸台701与套管8的带凹槽凸壁802的凹槽重合时，抽离释放管7解锁外管4与套管8的连接，释放套管8及内外夹9，完成手术。S3. Drive theinner tube 2 to rotate by rotating thehandle 1, untie the threaded connection between theinner tube 2 and theinner clamp 10, and adjust the release mechanism, that is, rotating therelease tube seat 6 drives therelease tube 7 to rotate, when theboss 701 of therelease tube 7 is connected to When the grooves of the groovedconvex wall 802 of thesleeve 8 overlap, therelease tube 7 is pulled out to unlock the connection between theouter tube 4 and thesleeve 8, and thesleeve 8 and the inner andouter clamps 9 are released to complete the operation.

应该理解，在本发明实施例的描述中，“后端”是指接近输送系统的操作者的一端，“前端”是指离开输送系统的操作者的一端。It should be understood that in the description of the embodiments of the present invention, the "rear end" refers to the end close to the operator of the conveying system, and the "front end" refers to the end leaving the operator of the conveying system.

本发明实施例为以修复二尖瓣瓣膜返流所作的描述，本领域技术人员可以理解的是本发明公开的修复二尖瓣瓣膜返流外还可以将其用于其他或者输送其他装置置入到身体的相应位置。本发明不局限于用于修复二尖瓣瓣膜返流一种方式。The embodiments of the present invention are described in terms of repairing mitral valve regurgitation. Those skilled in the art can understand that the repairing mitral valve regurgitation disclosed in the present invention can also be used for other devices or to deliver other devices. To the corresponding position of the body. The present invention is not limited to one method for repairing mitral valve regurgitation.

应当说明的是，以上所述仅是对本发明的优选实施例及原理进行了详细说明，对本领域的普通技术人员而言，依据本发明提供的思想，在具体实施方式上会有改变之处，而这些改变也应视为本发明的保护范围。It should be noted that the above is only a detailed description of the preferred embodiments and principles of the present invention. For those of ordinary skill in the art, according to the ideas provided by the present invention, there will be changes in specific implementations. These changes should also be regarded as the protection scope of the present invention.

Claims (10)

Translated fromChinese

一种用于组织夹合的装置，其特征在于，包括手柄、内管、内夹、外管座、外管、套管、外夹、释放机构；所述外管前端与套管连接，后端与外管座连接；所述外夹具有外夹座及两片位于外夹座上呈开口状的外夹片，所述外夹座套设于套管内且两片外夹片漏出于套管口一端，以使外夹座可以在套管内沿套管方向活动，由套管口带动外夹片夹合；所述内管依次贯穿外管座、外管、套管、外夹座套设于外管内，所述内管前端与内夹连接，后端与手柄连接，以使手柄依次带动内管、内夹沿外管方向在外管内活动；所述内夹具有内夹座及两片位于内夹座上呈开口状的内夹片，所述内夹座具有抵靠凸起，以使内夹座抵触外夹座时带动外夹座活动，所述内夹片与外夹片相适配，以使内夹片与外夹片抵触时组合为夹具；所述释放机构套设于外管前端与套管连接处，用于锁定或解锁外管与套管的连接。A device for tissue clamping, which is characterized by comprising a handle, an inner tube, an inner clamp, an outer tube seat, an outer tube, a sleeve, an outer clamp, and a release mechanism; the front end of the outer tube is connected with the sleeve, and the rear The end is connected to the outer tube seat; the outer clip has an outer clip seat and two open-shaped outer clips on the outer clip seat, the outer clip seat is sleeved in the sleeve and the two outer clips leak out of the sleeve One end of the nozzle so that the outer clamp can move in the casing along the direction of the sleeve, and the outer clamp is driven by the sleeve to be clamped; the inner tube passes through the outer tube socket, the outer tube, the sleeve, and the outer clamp sleeve in turn Set in the outer tube, the front end of the inner tube is connected with the inner clip, and the rear end is connected with the handle, so that the handle drives the inner tube and the inner clip to move in the outer tube in the direction of the outer tube in turn; the inner clip has an inner clip seat and two pieces An open inner clip located on the inner clip seat, the inner clip seat has abutting protrusions, so that when the inner clip seat is in contact with the outer clip seat, the outer clip seat is driven to move, and the inner clip is opposite to the outer clip seat. It is adapted so that the inner clip piece and the outer clip piece are combined to form a clamp when they collide; the release mechanism is sleeved at the connection between the front end of the outer tube and the sleeve, and is used to lock or unlock the connection between the outer tube and the sleeve.如权利要求1所述的一种用于组织夹合的装置，其特征在于，所述释放机构包括释放管、释放管座，所述释放管前端具有内腔和凸台，所述套管嵌设于内腔且外侧设有带凹槽凸壁，所述带凹槽凸壁与凸台相适配以形成旋转卡接结构；所述释放管座一端与释放管后端连接，用于旋转释放管。The device for tissue clamping according to claim 1, wherein the release mechanism comprises a release tube and a release tube seat, the front end of the release tube has an inner cavity and a boss, and the sleeve is embedded It is arranged in the inner cavity and is provided with a grooved convex wall on the outside, and the grooved convex wall is matched with the boss to form a rotating clamping structure; one end of the release pipe seat is connected with the rear end of the release pipe for rotating Release the tube.如权利要求2所述的一种用于组织夹合的装置，其特征在于，所述释放管座上还设有排空口，用于手术排空，所述释放管座另一端设有密封件；所述外管座尾端设有鲁尔接口。The device for tissue clamping according to claim 2, wherein the release tube socket is further provided with an emptying port for surgical emptying, and the other end of the release tube socket is provided with a seal Pieces; The end of the outer tube seat is provided with a Luer interface.如权利要求2所述的一种用于组织夹合的装置，其特征在于，所述内管直径为0.5-2.5mm，所述外管直径为2.6-5mm，所述两片外夹片开口角度为100-160度。The device for tissue clamping according to claim 2, wherein the diameter of the inner tube is 0.5-2.5mm, the diameter of the outer tube is 2.6-5mm, and the two outer clips have openings. The angle is 100-160 degrees.如权利要求1所述的一种用于组织夹合的装置，其特征在于，所述套管管直径小于外管直径以使套管插接入外管，所述外管内部具有限位台阶，所述限位台阶用于抵靠套管底部。The device for tissue clamping according to claim 1, wherein the diameter of the cannula tube is smaller than the diameter of the outer tube so that the cannula can be inserted into the outer tube, and the outer tube has a limiting step inside. , The limit step is used to abut the bottom of the casing.如权利要求5所述的一种用于组织夹合的装置，其特征在于，所述外管 前端还具有限位凹槽，所述套管具有限位凸起，所述限位凹槽与限位凸起相适配限制套管沿外管周向活动。The device for tissue clamping according to claim 5, wherein the front end of the outer tube further has a limiting groove, the sleeve has a limiting protrusion, and the limiting groove is connected to The limiting protrusion is adapted to restrict the sleeve from moving in the circumferential direction of the outer tube.如权利要求1所述的一种用于组织夹合的装置，其特征在于，所述套管的套管壁上设有若干孔洞，用于加速套管植入内皮化。The device for tissue clamping according to claim 1, characterized in that a number of holes are provided on the sleeve wall of the sleeve for accelerating the endothelialization of the sleeve implantation.如权利要求1所述的一种用于组织夹合的装置，其特征在于，所述内夹片和外夹片抵触面侧分别设有夹齿，所述外夹片外侧底端还设有卡接凸起。The device for tissue clamping according to claim 1, wherein the abutting surface side of the inner clip and the outer clip are respectively provided with clamping teeth, and the outer bottom end of the outer clip is also provided with Snap protrusion.如权利要求1所述的一种用于组织夹合的装置，其特征在于，所述套管内腔管口端部设有内螺纹，所述外夹座外侧设有与内螺纹相适配的外螺纹。The device for tissue clamping according to claim 1, wherein the end of the inner cavity of the sleeve is provided with an internal thread, and the outer side of the outer clamp seat is provided with an internal thread that is compatible with the internal thread. External thread.一种用于组织夹合的装置使用方法，通过权利要求1-9中的任意一条所述的用于组织夹合的装置实现，其特征在于，包括如下步骤：A method for using a device for tissue clamping is implemented by the device for tissue clamping according to any one of claims 1-9, and is characterized in that it comprises the following steps:S1.将用于组织夹合的装置送至心脏瓣膜处，通过手柄控制内管前后移动，调节内夹的位置，使外夹片和内夹片位置分别位于脱垂的瓣叶内外两侧；S1. Send the device for tissue clamping to the heart valve, control the inner tube to move back and forth through the handle, and adjust the position of the inner clip so that the positions of the outer clip and the inner clip are located on the inner and outer sides of the prolapsed valve leaflet;S2.抽动手柄将内夹和外夹收入到套管内，夹合瓣膜；S2. Twitch the handle to collect the inner clip and the outer clip into the sleeve and clamp the valve;S3.解开内管和内夹的连接，调整释放机构，解锁外管与套管的连接，释放套管及内外夹。S3. Unlock the connection between the inner tube and the inner clamp, adjust the release mechanism, unlock the connection between the outer tube and the sleeve, and release the sleeve and the inner and outer clamps.

Images