An organization clamping device and its clip body

Abstract

The present application discloses a tissue clamping device and a clip body thereof. The clip body of the tissue clamping device includes a support portion, a first inner clamping arm, a first outer clamping arm, a second inner clamping arm, and a second outer clamping arm. One side of the support portion is sequentially and bendably connected to the first inner clamping arm and the first outer clamping arm, and the other side of the support portion is sequentially and bendably connected to the second inner clamping arm and the second outer clamping arm. The clip body is an integrally formed structure.

Description

Technical Field

[0001] This application relates to the field of medical supplies, and particularly to a tissue clamping device and its clip body. Background Art

[0002] In surgical repair operations of body tissues, it is usually necessary to use a tissue clamping device to clamp and fix the tissues. Taking the treatment of mitral regurgitation, a relatively common heart disease, as an example, the mitral valve is located between the left atrium and the left ventricle. During the contraction of the left ventricle, the mitral valve acts as a check valve to tightly close the atrioventricular orifice and prevent blood from flowing back from the left ventricle into the left atrium. However, when the mitral valve is diseased, it may be difficult for the mitral valve to fully close during the contraction of the left ventricle, resulting in a large amount of regurgitant blood being received by the left atrium. This may cause a sharp increase in the pressure of the left atrium and pulmonary veins, an increase in the volume load during the diastolic period of the left ventricle, and further lead to a series of pathological changes such as left ventricular dilation and pulmonary hypertension, and ultimately lead to clinical manifestations such as heart failure and arrhythmia, and may endanger life when severe. In the operation for treating mitral regurgitation, a tissue clamping device can be used to clamp the opposite sides of the mitral valve, so that a large hole between the valve leaflets of the mitral valve becomes two small holes, reducing the regurgitation area, thereby effectively preventing the occurrence of mitral regurgitation. Similarly, the tissue clamping device can also be applied to the tricuspid valve of the heart to reduce the regurgitation area by clamping the two side leaflets. The clip body is an important component for tissue clamping, and the opening and closing of the clip arms of the clip body assist the tissue clamping device to achieve tissue clamping. Summary of the Invention

[0003] One embodiment of this application provides a clip body of a tissue clamping device. The clip body includes a support portion, a first inner clip arm, a first outer clip arm, a second inner clip arm, and a second outer clip arm. One side of the support portion is sequentially and bendably connected to the first inner clip arm and the first outer clip arm, and the other side of the support portion is sequentially and bendably connected to the second inner clip arm and the second outer clip arm. The clip body is an integrally formed structure.

[0004] One embodiment of this application provides a tissue clamping device, which includes the clip body according to any embodiment of this application. Brief Description of the Drawings

[0005] This application will be further described in the form of exemplary embodiments, and these exemplary embodiments will be described in detail through the drawings. These embodiments are not restrictive. In these embodiments, the same numbers represent the same structures, where:

[0006] Figure 1 is a schematic structural diagram of a tissue clamping device according to some embodiments of this application;

[0007] Figure 2 Schematic structural diagram of the retracted state of the tissue clamping device according to some embodiments of the present application;

[0008] Figure 3 Top view of the tissue clamping device according to some embodiments of the present application;

[0009] Figure 4 Schematic structural diagram of the retracted state of the clip body of the tissue clamping device according to some embodiments of the present application;

[0010] Figure 5 Schematic structural diagram of the open state of the clip body of the tissue clamping device according to some embodiments of the present application;

[0011] Figure 6 Schematic structural diagram of another open state of the clip body of the tissue clamping device according to some embodiments of the present application;

[0012] Figure 7 Schematic connection diagram of the clip body and the clip piece of the tissue clamping according to some embodiments of the present application;

[0013] Figure 8 Front view structural diagram of the S-bar bending structure of the clip body of the tissue clamping device according to some embodiments of the present application;

[0014] Figure 9 Side view schematic diagram of the S-bar bending structure of the clip body of the tissue clamping device according to some embodiments of the present application;

[0015] Figure 10 Schematic diagram of the bending state of the S-bar bending structure of the clip body of the tissue clamping device according to some embodiments of the present application;

[0016] Figure 11 Schematic diagram of the hourglass bending structure of the clip body of the tissue clamping device according to some embodiments of the present application;

[0017] Figure 12 Schematic structural diagram of the clip body of the tissue clamping device according to some embodiments of the present application;

[0018] Figure 13 According to some embodiments of the present application Figure 12 Side view of the clip body of the tissue clamping device;

[0019] Figure 14 Schematic structural diagram of the clip body of the tissue clamping device according to some other embodiments of the present application;

[0020] Figure 15It is a schematic structural diagram of the clip body of the tissue clamping device shown in some other embodiments of the present application;

[0021] Figure 16 It is a schematic connection diagram of the clip body and the barbed clip of the tissue clamping device shown in some embodiments of the present application;

[0022] Figure 17 It is a schematic structural diagram of the integrally formed barbed clip of the tissue clamping device shown in some embodiments of the present application;

[0023] Figure 18 It is a schematic diagram of the integrally formed structure of the barbed clip of the tissue clamping device shown in some other embodiments of the present application;

[0024] Figure 19 It is a schematic structural diagram of the detachable connection between the barbs and the clamping part of the barbed clip of the tissue clamping device shown in some embodiments of the present application;

[0025] Figure 20 It is a schematic structural diagram of the barbs of the barbed clip of the tissue clamping device shown in some embodiments of the present application;

[0026] Figure 21 It is a schematic structural diagram of the barbs of the barbed clip of the tissue clamping device shown in some other embodiments of the present application;

[0027] Figure 22 It is a schematic diagram of the cutting shape of the barbed clip of the tissue clamping device shown in some embodiments of the present application;

[0028] Figure 23 It is a schematic structural diagram of the barbed clip of the tissue clamping device shown in some embodiments of the present application;

[0029] Figure 24 It is a schematic structural diagram of the barbed clip of the tissue clamping device shown in some other embodiments of the present application;

[0030] Figure 25 It is a schematic structural diagram of the inner clamping arm of the tissue clamping device shown in some embodiments of the present application;

[0031] Figure 26 It is a schematic connection diagram of the barbed clip, the inner clamping arm and the fixing ring of the tissue clamping device shown in some embodiments of the present application;

[0032] Figure 27 It is a schematic structural diagram of the integral molding of the barbed clip and the clip body of the tissue clamping device shown in some embodiments of the present application;

[0033] Figure 28Schematic structural diagram of the locking mechanism of the tissue clamping device shown in some embodiments of the present application;

[0034] Figure 29 Schematic structural diagram of the tissue clamping device with a locking mechanism shown in some embodiments of the present application;

[0035] Figure 30 Schematic structural diagram of the locking mechanism of the tissue clamping device shown in some embodiments of the present application, where the locking fins of the locking tube are in the retracted state;

[0036] Figure 31 Schematic structural diagram of the locking mechanism of the tissue clamping device shown in some embodiments of the present application, where the locking fins of the locking tube are in the open state;

[0037] Figure 32 Schematic structural diagram of the locking mechanism of the tissue clamping device shown in some embodiments of the present application when it is not locked;

[0038] Figure 33 Schematic structural diagram of the locking mechanism of the tissue clamping device shown in some embodiments of the present application when it is locked;

[0039] Figure 34 Schematic structural diagram of the elastic support of the tissue clamping device shown in some embodiments of the present application;

[0040] Figure 35 Schematic structural diagram of the elastic support of the tissue clamping device shown in some other embodiments of the present application;

[0041] Figure 36 Schematic structural diagram of the elastic support of the tissue clamping device shown in some further embodiments of the present application;

[0042] Figure 37 Schematic structural diagram of the elastic support of the tissue clamping device shown in some other embodiments of the present application;

[0043] Figure 38 As shown in some embodiments of the present application Figure 37 Top view of the elastic support;

[0044] Figure 39 According to some embodiments of the present application Figure 37 Schematic structural diagram of the heat-treated elastic support;

[0045] Figure 40 Schematic structural diagram of the first connecting member of the tissue clamping device shown in some embodiments of the present application;

[0046] Figure 41Schematic diagram of the connection between the first connecting member and the clip body of the tissue clamping device according to some embodiments of the present application;

[0047] Figure 42 Schematic diagram of the connection between the clip body and the conveying member of the tissue clamping device according to some embodiments of the present application;

[0048] Figure 43 Schematic diagram of the structure of the second connecting member of the tissue clamping device according to some embodiments of the present application;

[0049] Figure 44 Schematic diagram of the connection between the clip body and the second connecting member according to some embodiments of the present application;

[0050] Figure 45 Schematic diagram of the structure of the second connecting member of the tissue clamping device according to another embodiment of the present application;

[0051] Figure 46 Schematic diagram of the connection between the clip body and the second connecting member according to another embodiment of the present application.

[0052] Description of reference numerals: 100 - clip body, 200 - first connecting member, 300 - second connecting member, 400 - clip piece, 500 - locking mechanism, 600 - braking rod, 700 - elastic bracket, 800 - disengaging member, 110 - supporting portion, 120 - first inner clamping arm, 121 - clamping hole, 122 - fixing groove, 125 - through hole, 130 - second inner clamping arm, 140 - first outer clamping arm, 150 - second outer clamping arm, 160 - first bending structure, 170 - second bending structure, 202 - mounting bayonet, 204 - through hole, 206 - convex block, 302 - connecting hole, 304 - mounting hole, 306 - convex block, 410 - first clip piece, 420 - second clip piece, 430 - fixing portion, 440 - clamping portion, 450 - barb, 451 - snap ring, 452 - through hole, 460 - fixing ring, 510 - locking tube, 520 - locking member, 530 - sleeve, 511 - locking fin, 710 - first support rod, 712 - first arc segment, 714 - second arc segment, 716 - third arc segment, 720 - second support rod, 730 - first mounting portion, 740 - second mounting portion, 750 - first connecting portion, 760 - second connecting portion, 810 - main body, 820 - first connecting piece, 830 - second connecting piece, 840 - fixing support rod, 910 - S - rod bending structure, 920 - waist - thinning bending structure, 911 - straight rod, 912 - bent rod, 913 - connecting rod, 930 - through hole. Detailed Description of the Invention

[0053] To make the objectives, technical solutions and advantages of the present application more clear and understandable, the present application will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0054] On the contrary, the present application covers any alternatives, modifications, equivalent methods and solutions made to the essence and scope of the present application as defined by the claims. Further, in order to enable the public to have a better understanding of the present application, in the following detailed description of the present application, some specific details are described in detail. Those skilled in the art can fully understand the present application without the description of these details.

[0055] The embodiment of the present application relates to a tissue clamping device. The inner clamping arms of the clip body of the tissue clamping device can be relatively opened or closed, and can clamp tissues after being combined with the clip pieces. The tissue clamping device can be applied to various occasions. For example, it can be used for clamping tissues such as heart valves (such as mitral valves, tricuspid valves) or vascular valves, and can reach a predetermined position through various paths during the process of tissue clamping. The present application does not limit this.

[0056] Figure 1 is a schematic structural diagram of a tissue clamping device shown in some embodiments of the present application; Figure 2 is a schematic structural diagram of the tissue clamping device in a retracted state shown in some embodiments of the present application; Figure 3 is a top view of the tissue clamping device shown in some embodiments of the present application; Figure 4 is a schematic structural diagram of the clip body of the tissue clamping device in a retracted state shown in some embodiments of the present application; Figure 5 is a schematic structural diagram of the clip body of the tissue clamping device in an open state shown in some embodiments of the present application; Figure 6 is a schematic structural diagram of another open state of the clip body of the tissue clamping device shown in some embodiments of the present application; Figure 7 is a schematic connection diagram of the clip body and the clip piece of the tissue clamping shown in some embodiments of the present application. The following will be combined with Figures 1 - 7 to describe in detail the clip body for the tissue clamping device involved in the embodiment of the present application. It should be noted that the following embodiments are only used to explain the present application and do not constitute a limitation to the present application.

[0057] In the embodiment of the present application, as Figures 1 - 7As shown, the tissue clamping device may include a clip body 100, a first connecting member 200, a second connecting member 300, and clip pieces 400. The clip body 100 may include a support portion 110, a first inner clamping arm 120, a first outer clamping arm 140, a second inner clamping arm 130, and a second outer clamping arm 150. One side of the support portion 110 is sequentially and bendably connected to the first inner clamping arm 120 and the first outer clamping arm 140, and the other side of the support portion 110 is sequentially and bendably connected to the second inner clamping arm 130 and the second outer clamping arm 150. The bendable connection between the support portion 110 and the first inner clamping arm 120 and the bendable connection between the support portion 110 and the second inner clamping arm 130 can be understood as follows: the connection between the first inner clamping arm 120 and the support portion 110 and the connection between the second inner clamping arm 130 and the support portion 110 can be bent, the first inner clamping arm 120 and the second inner clamping arm 130 can be bent relative to the support portion 110 and close relative to each other, and the first inner clamping arm 120 and the second inner clamping arm 130 can also be bent away from the support portion 110 and open relative to each other. The bendable connection between the first inner clamping arm 120 and the first outer clamping arm 140 and the bendable connection between the second inner clamping arm 130 and the second outer clamping arm 150 can be understood as follows: the connection between the first inner clamping arm 120 and the first outer clamping arm 140 and the connection between the second inner clamping arm 130 and the second outer clamping arm 150 can be bent, the angle between the first inner clamping arm 120 and the first outer clamping arm 140 can change, and the angle between the second inner clamping arm 130 and the second outer clamping arm 150 can change. In some embodiments, the number of inner clamping arms and outer clamping arms can be increased as needed. For example, it may further include a third inner clamping arm, a fourth inner clamping arm, a third outer clamping arm, and a fourth outer clamping arm, and the support portion 110 can also be sequentially and bendably connected to the third inner clamping arm and the third outer clamping arm, and the support portion 110 can be sequentially and bendably connected to the fourth inner clamping arm and the fourth outer clamping arm.

[0058] In some embodiments, the clip body 100 may be an integrally formed structure. Specifically, during the production and manufacturing process of the clip body 100, a metal pipe can be cut (for example, laser cut) to form the clip body 100. In some alternative embodiments, the clip body 100 can also be formed by weaving metal wires. The clip body 100 can be connected between the first connecting member 200 and the second connecting member 300, and the relative movement of the first connecting member 200 and the second connecting member 300 can drive the first inner clamping arm 120 and the second inner clamping arm 130 to open or close relative to each other. The state where the first inner clamping arm 120 and the second inner clamping arm 130 close relative to each other is as Figure 4 shown. The angle at which the first inner clamping arm 120 and the second inner clamping arm 130 open relative to each other can be any angle, such as 40°, 90°, 120°, 180°, 270°, 350°, 360°, etc. For example, Figure 5 shown is the state where the first inner clamping arm 120 and the second inner clamping arm 130 open 180° relative to each other; Figure 6Shown is a state where the first inner clamping arm 120 and the second inner clamping arm 130 are relatively opened and close to 360°. In some embodiments, such as Figures 1 - 2 shown, one end (the upper end shown in the figure) of the support portion 110 is connected (such as fixedly connected) to the first connecting member 200, and one end (the lower end shown in the figure) of the first outer clamping arm 140 and one end (the lower end shown in the figure) of the second outer clamping arm 150 are respectively connected (such as fixedly connected) to the second connecting member 300. Through such a setting, when the second connecting member 300 moves relative to the first connecting member 200, the second connecting member 300 can move relative to the support portion 110. When the second connecting member 300 moves away from the support portion 110, driven by the second connecting member 300, the first outer clamping arm 140 and the second outer clamping arm 150 can respectively pull the first inner clamping arm 120 and the second inner clamping arm 130 to open relatively. In some embodiments, in order to make the opening angle range of the first inner clamping arm 120 and the second inner clamping arm 130 larger, one end of the first outer clamping arm 140 and one end of the second outer clamping arm 150 can be bendably connected to the second connecting member 300.

[0059] In some embodiments, such as Figure 7 shown, the clip 400 may include a first clip 410 provided on the first inner clamping arm 120 and a second clip 420 provided on the second inner clamping arm 130. The first clip 410 and the second clip 420 can respectively open and close relative to the first inner clamping arm 120 and the second inner clamping arm 130, so that the tissue can be clamped between the first clip 410 and the first inner clamping arm 120 and between the second clip 420 and the second inner clamping arm 130. In some embodiments, the clip 400 can be a barbed clip. In some embodiments, the clip 400 can also be other types of clips. For example, on the side of the clip 400 facing the inner clamping arm (such as the first inner clamping arm 120 or the second inner clamping arm 130), barbs and / or protrusions etc. can be provided.

[0060] In some embodiments, the tissue clamping device may further include a first control mechanism for controlling the movement of the second connecting member 300 relative to the first connecting member 200 to control the relative closing or opening of the first inner clamping arm 120 and the second inner clamping arm 130. The first control mechanism may include a brake rod 600 which can pass through the support portion 110 and be detachably connected (such as by threaded connection) to the second connecting member 300. The brake rod 600 can push or pull the second connecting member 300 to move it relative to the first connecting member 200. In some embodiments, the tissue clamping device may further include a second control mechanism for controlling the opening or closing of the first clamping piece 410 and the second clamping piece 420 relative to the first inner clamping arm 120 and the second inner clamping arm 130 respectively. The second control mechanism may include a first traction cable connected to the first clamping piece 410 and a second traction cable connected to the second clamping piece 420. For example, the first traction cable may be connected to the through hole at the opening and closing end of the first clamping piece 410, and the second traction cable may be connected to the through hole at the opening and closing end of the second clamping piece 420. The first clamping piece 410 and the second clamping piece 420 may be prefabricated with a resilience force towards the first inner clamping arm 120 and the second inner clamping arm 130 respectively. When the first traction cable and / or the second traction cable is pulled, the first clamping piece and / or the second clamping piece can be opened relative to the first inner clamping arm 120 and the second inner clamping arm 130 under the pulling force of the traction cable; when the first traction cable and / or the second traction cable is relaxed, the first clamping piece 410 can be closed with the first inner clamping arm 120 under the action of the resilience force, and / or the second clamping piece 420 can be closed with the second inner clamping arm 130 under the action of the resilience force.

[0061] In some embodiments, one side of the support portion 110 is connected to the first inner clamping arm 120 through a first bending structure 160, and the other side of the support portion 110 is connected to the second inner clamping arm 130 through the first bending structure 160. The first bending structure 160 may be an S-bar bending structure 910 or a waist-leaning bending structure 920. The first inner clamping arm 120 is connected to the first outer clamping arm 140 through a second bending structure 170, and the second inner clamping arm 130 is connected to the second outer clamping arm 150 through the second bending structure 170. The second bending structure 170 may be an S-bar bending structure 910 or a waist-leaning bending structure 920. Due to their own structural characteristics and / or material characteristics, both the first bending structure 160 and the second bending structure 170 can achieve bending by themselves. The specific structures of the first bending structure 160 and the second bending structure 170 may be the same or different. For example, when the first bending structure 160 is an S-bar bending structure 910, the second bending structure 170 may be an S-bar bending structure 910 or a waist-leaning bending structure 920. Both the S-bar bending structure 910 and the waist-leaning bending structure 920 can be heat-treated. The S-bar bending structure 910 and the waist-leaning bending structure 920 are prone to heat-treatment deformation, and can make the stress distribution at the bending part uniform, and are not easy to break after multiple bends, so as to extend the service life of the clip body 100.

[0062] Figure 8 is a front view structural schematic diagram of the S-shaped rod bending structure of the clip body of the tissue clamping device shown in some embodiments of the present application. Figure 9 is a side view structural schematic diagram of the S-shaped rod bending structure of the clip body of the tissue clamping device shown in some embodiments of the present application. Figure 10 is a schematic diagram of the bending state of the S-shaped rod bending structure of the clip body of the tissue clamping device shown in some embodiments of the present application. As Figures 8 - 10 shown, the S-shaped rod bending structure 910 can be understood as a bendable rod body structure similar to an "S" shape. In some embodiments, the S-shaped rod bending structure 910 may at least include three straight rods 911 and two bent rods 912, and the three straight rods 911 are parallel to each other and the three straight rods 911 are connected end to end through the two bent rods 912. In Figures 8 - 9 the shown S-shaped rod bending structure 910, a single row (such as the following in Figure 8 ) of the S-shaped rod bending structure 910 may include seven straight rods 911 and six bent rods 912, and the seven straight rods 911 are parallel to each other and are connected end to end through the six bent rods 912. In some embodiments, the number of straight rods 911 and bent rods 912 of the S-shaped rod bending structure 910 may also be other numbers. Figure 10 shows the S-shaped rod bending structure 910 during bending, Figures 8 - 9 shows the S-shaped rod bending structure 910 when not bent. As Figure 10 shown, when the S-shaped rod bending structure 910 is bent, each straight rod 911 still remains relatively parallel, while the S-shaped rod bending structure 910 bends at each bent rod 912. Through such a setting, the S-shaped rod bending structure 910 can be more easily bent. In some embodiments, the S-shaped rod bending structure 910 can be arranged in multiple rows (such as two rows, three rows, etc.). As Figure 8 shown, it includes two upper and lower rows of S-shaped rod bending structures 910. Setting the S-shaped rod bending structure 910 in multiple rows can make the S-shaped rod bending structure 910 more stable during bending, such as avoiding side bending and / or avoiding twisting between multiple straight rods 911 during bending. In some embodiments, when the S-shaped rod bending structure 910 is arranged in multiple rows, the bent rods 912 between adjacent two rows of S-shaped rod bending structures 910 can be connected by a connecting rod 913 (as Figure 8 shown). By setting the connecting rod 913 to connect adjacent two rows of S-shaped rod bending structures 910, the stability of the S-shaped rod bending structure 910 during bending can be effectively improved. In some embodiments, the S-shaped rod bending structure 910 can be cut from a sheet or pipe made of shape memory alloy. The S-shaped rod bending structure 910 after heat treatment and shaping can have a prefabricated resilience. The S-shaped rod bending structure 910 is easy to bend, and has good resilience and excellent fatigue resistance.

[0063] Figure 11 It is a schematic diagram of the waist-thinning bending structure of the clip body of the tissue clamping device shown in some embodiments of the present application. As Figure 11 shown, the first inner clip arm 120 and the first outer clip arm 140 can be connected by a waist-thinning bending structure 920. The waist-thinning bending structure 920 can be understood as a bendable rod-shaped structure with a width smaller in the middle than at both ends. By setting the width of the middle part of the waist-thinning bending structure 920 to be smaller than that of both ends, it can make the middle part of the waist-thinning bending structure 920 easier to bend. The waist-thinning bending structure 920 can be cut from a sheet or tube of shape memory alloy. The waist-thinning bending structure 920 after heat treatment and shaping can have a preformed resilience. In some alternative embodiments, the waist-thinning bending structure 920 can also be understood as a bendable structure with a cross-sectional area smaller in the middle than at both ends (as shown by the second bending structure 170 in Figure 15 ).

[0064] Figure 12 It is a schematic diagram of the structure of the clip body of the tissue clamping device shown in some embodiments of the present application; Figure 13 It is shown in some embodiments of the present application Figure 12 a side view of the clip body of the tissue clamping device; Figure 14 It is a schematic diagram of the structure of the clip body of the tissue clamping device shown in some other embodiments of the present application; Figure 15 It is a schematic diagram of the structure of the clip body of the tissue clamping device shown in some further embodiments of the present application. In some embodiments, as Figures 12 - 15 shown, the support part 110 can be a grid structure. The grid structure can include one or a combination of a rhombic grid, a circular grid, a rectangular grid, a square grid, a triangular grid, or a regular polygon grid, etc. In some embodiments, the grid structure can determine the hardness of the support part 110, and those skilled in the art can design the size and shape of the grid according to the hardness requirements of the support part 110. For example, when a harder support part 110 is needed, a triangular grid can be selected or the grid can be set smaller; when a softer support part 110 is needed, a regular polygon grid can be selected or the grid can be set larger. By setting the support part 110 as a grid structure, the support part after heat treatment can also have elasticity, so as to facilitate passing through the delivery tube when delivering the tissue clamping device. In addition, the grid-structured support part 110 can also effectively fill the space between the first inner clip arm 120 and the second inner clip arm 130, and can prevent the formation of blood clots after the tissue clamping device clamps the tissue.

[0065] In some embodiments, the cross-sectional shape of the support portion 110 may be circular or elliptical, and the cross-sectional area of the middle of the support portion 110 may be larger than the cross-sectional areas of its two ends. The cross-section is a plane perpendicular to the brake lever 600. For example, the shape of the support portion 110 may be approximately spherical or ellipsoidal. The beneficial effects that may be brought about by such a design include, but are not limited to: making the support portion 110 not easily damage tissues; facilitating the tissue clamping device to be transported to the tissue to be clamped through the pipe fitting of the delivery system; and being able to effectively support the clamped tissue. In some embodiments, the support portion 110 may also be in the shape of a pear, a cylinder, etc. Those skilled in the art can determine the support portion 110 of the clip body 100 to be of different shapes according to the specific situation of the tissue to be clamped (such as the shape of the coaptation edge of the mitral valve leaflet), so that the shape of the support portion 110 better fits the shape of the tissue (such as the coaptation edge of the mitral valve leaflet) and the clamping effect is better.

[0066] In some embodiments, such as Figure 12 and Figure 14 shown, the first outer clamping arm 140 and the second outer clamping arm 150 may include a plurality of through holes 930, and the plurality of through holes 930 can assist the first outer clamping arm 140 and the second outer clamping arm 150 to deform during the heat treatment process. In some embodiments, each through hole may extend along the width direction of the first outer clamping arm 140 and the second outer clamping arm 150, and the plurality of through holes may be arranged at intervals along the length direction of the first outer clamping arm 140 and the second outer clamping arm 150. In some alternative embodiments, the plurality of through holes 930 may also be of other shapes and / or other arrangement manners. For example, the plurality of through holes 930 may be square holes, round holes, polygonal holes, etc. Again, for example, the plurality of through holes 930 may be arranged in multiple columns along the width direction of the first outer clamping arm 140 and the second outer clamping arm 150. In some embodiments, when the first inner clamping arm 120 and the second inner clamping arm 130 are closed, in order to enable the first outer clamping arm 140 and the second outer clamping arm 150 to better wrap the support portion 110, the first inner clamping arm 120 and the second inner clamping arm 130, the first outer clamping arm 140 and the second outer clamping arm 150 may be bent and deformed into an arc shape along the length direction after heat treatment (such as Figures 4 - 5 shown).

[0067] In some embodiments, the clip body 100 may be an integrally formed structure made by cutting and heat treatment shaping a shape memory alloy pipe. The shape memory alloy may include nickel-titanium alloy, cobalt-chromium alloy, etc. As Figure 13 shown is Figure 12 a side view of the clip body of the tissue clamping device. Through Figure 13 it can be seen that Figure 12 the clip body is a pipe integral cutting and forming structure. The cutting method of the pipe may include laser cutting, water cutting, etc. Similarly, Figures 14 - 15These are schematic structural diagrams of the clip body that is integrally formed. During the heat treatment of the clip body 100 based on the integrally formed clip body 100 shown in Figures 12 - 15 , deformation can occur in various parts (such as the support part, the first bending structure 160, the second bending structure 170, the first outer clip arm 140, or the second outer clip arm 150, etc.). For example, during the heat treatment, the two ends of the support part 110 are made to converge inward, so that the cross-sectional area in the middle of the support part is larger than the cross-sectional areas at its two ends. Another example is that during the heat treatment, the first outer clip arm 140 and the second outer clip arm 150 are bent into an arc shape, and the first bending structure 160 and the second bending structure 170 are made to form a bend. When heat-treating the clip body 100, the various parts of the clip body 100 can be deformed through a mold. The shape memory alloy can remember the shape after being heat-treated and shaped (such as the shape shown in Figure 4 ). When the tissue is clamped, the clip body 100 will have a restoring force to return to the original shape and be able to clamp the tissue. It should be noted that the clip body 100 shown in Figures 1 - 7 is only used to illustrate the general shape of the clip body 100, and does not mean that the final shape of the clip body is the same as that shown in Figures 1 - 7 . For example, based on the clip body 100 shown in Figures 1 - 7 , the support part 110 of the clip body 100 can be a grid structure, and the first bending structure 160 and the second bending structure 170 can be an S-bar bending structure 910 or a waist-thinning bending structure 920.

[0068] In some embodiments, the clip 400 can include a first clip 410 provided on the first inner clip arm 120 and a second clip 420 provided on the second inner clip arm 130, and the first clip 410 can be the same as the second clip 420. Specifically, the clip 400 can include a fixing part 430 and a clamping part 440, and the fixing part 430 and the clamping part 440 can be connected by a bending part. In some embodiments, the clip 400 can be a barbed clip, and the barbed clip can include a fixing part 430, a clamping part 440, and barbs 450. One end of the clamping part 440 can be connected to one end of the fixing part 430 through a bending part, and the other end of the clamping part 440 can be provided with barbs 450. Figure 16 This is a schematic connection diagram of the clip body of the tissue clamping device and the barbed clip according to some embodiments of the present application. As shown in Figure 16As shown, the barbs 450 can be located on the side of the clamping portion 440 of the clip 400 (such as the first clip 410 or the second clip 420) facing the inner clamping arm (such as the first inner clamping arm 120 or the second inner clamping arm 130). The fixing portion 430 can be used to fix the clip 400 (such as the first clip 410 or the second clip 420) to the inner clamping arm (such as the first inner clamping arm 120 or the second inner clamping arm 130). The clamping portion 440 can be used to cooperate with the inner clamping arm (such as the first inner clamping arm 120 or the second inner clamping arm 130) to clamp tissue. One end of the fixing portion 430 and one end of the clamping portion 440 can be connected by a bending portion, so that the clip 400 (such as the first clip 410 or the second clip 420) can open and close relative to the inner clamping arm (such as the first inner clamping arm 120 or the second inner clamping arm 130). The setting of the barbs 450 can effectively prevent the tissue from slipping out between the clip 400 and the inner clamping arm, and can make the clamping of the tissue by the tissue clamping device more stable.

[0069] In some embodiments, the bending portion can be an S-bar bending structure 910 (such as Figure 19 and Figures 22 - 24 as shown). The S-bar bending structure 910 is prone to heat treatment deformation, and can make the stress sharing at the bending part uniform and not easy to break after multiple bendings. In addition, by setting the bending portion as the S-bar bending structure 910, the clip 400 can be bent smoothly and not easy to break during the bending process. In some embodiments, the S-bar bending structure 910 can at least include three straight bars 911 and two bent bars 912, and the three straight bars 911 are parallel to each other and the three straight bars 911 are connected end to end by the two bent bars 912. For more details about the S-bar bending structure 910, reference can be made to Figures 8 - 10 and its related description.

[0070] In some embodiments, the fixing portion 430, the clamping portion 440 and the barbs 450 can be an integrally formed structure. Specifically, the fixing portion 430, the clamping portion 440 and the barbs 450 can be integrally formed by cutting (such as laser cutting) a plate or a pipe. Through the integral forming of the fixing portion 430, the clamping portion 440 and the barbs 450, the barb clip structure can be stable, the connection of each component can be reliable and it is convenient for production and manufacturing. In some embodiments, the barbs 450 can include multiple barbs, such as 3, 4, 5, 7, 10, etc. The multiple barbs can be arranged in a row or in multiple rows. The outer wall of the barb can be a plane or a circular arc surface. Figure 17 is a schematic structural diagram of an integrally formed barb clip of a tissue clamping device according to some embodiments of the present application. In some embodiments, at least one barb can be connected to the other end of the clamping portion 440 by an S-bar bending structure 910. Preferably, such as Figure 17As shown, all barbs can be connected to the other end of the clamping part 440 through the S-bar bending structure 910. The design of connecting through the S-bar bending structure 910 can facilitate the bending of the barbs during the heat treatment process. For example, the barbs can be bent at 90° to the clamping part 440. Figure 18 is a schematic structural view of an integrally formed barbed clip of the tissue clamping device according to some other embodiments of the present application. In some embodiments, as Figure 18 shown, through holes 452 can be formed in at least one barb (such as all barbs). In some embodiments, the through holes 452 can penetrate the barbs along the thickness direction of the barbs. The number of through holes on each barb can be one or more. The shapes of the through holes can include thorn-shaped, square, circular, triangular, etc. Preferably, each barb can include one through hole 452, and the shape of the through hole is similar to the outer shape of the barb. During the production and manufacturing process of the barbed clip, the design of the through holes can facilitate the bending and forming of the barbs during the heat treatment process. In some alternative embodiments, the through holes on the barbs can also penetrate along other directions (such as the width direction of the barbs).

[0071] In some embodiments, the barb 450 can be detachably connected to the other end of the clamping part 440. Those skilled in the art can choose whether to install the barb 450 on the clamping part 440 according to actual needs, or choose which barb 450 to install on the clamping part 440. Figure 19 is a schematic structural view of the detachable connection between the barb and the clamping part of the barbed clip of the tissue clamping device according to some embodiments of the present application; Figure 20 is a schematic structural view of the barb of the barbed clip of the tissue clamping device according to some embodiments of the present application; Figure 21 is a schematic structural view of the barb of the barbed clip of the tissue clamping device according to some other embodiments of the present application. As Figures 19 - 21 shown, the other end of the clamping part 440 can include a card slot, and the barb 450 can include a snap ring 451, and the snap ring 451 can be engaged with the card slot. Through such a setting, the barb 450 can be conveniently and firmly installed on the clamping part 440. In addition, setting the barb 450 and the clamping part 440 to be detachably connected can avoid the problem that the barb may be difficult to bend during the heat treatment process. In some embodiments, the snap ring 451 can be made of an elastic material or a superelastic metal (such as nitinol), so as to facilitate the sleeving of the snap ring 451 onto the card slot. In some embodiments, as Figures 20 - 21 shown, the opposite sides of the snap ring 451 can be straight lines or arcs to be applicable to different types of clamping parts 440 (such as clamping parts cut from plates or clamping parts cut from pipes). In some embodiments, the number, shape, and arrangement of the barbs on the barb 450 can be adjusted according to the actual situation (such as the characteristics of the tissue to be clamped).

[0072] In some embodiments, the fixing portion 430 and the clamping portion 440 may be an integrally formed structure made of a shape memory alloy by cutting and heat treatment. The shape memory alloy may include nickel-titanium alloy, cobalt-chromium alloy, etc. Figure 22 It is a schematic diagram of the cutting shape of the barbed clip of the tissue clamping device shown in some embodiments of the present application; Figure 23 It is a schematic structural diagram of the barbed clip of the tissue clamping device shown in some embodiments of the present application; Figure 24 It is a schematic structural diagram of the barbed clip of the tissue clamping device shown in some other embodiments of the present application. As Figure 22 shown, the barbed clip may be integrally cut and formed from a shape memory alloy sheet. As Figure 23 and Figure 24 shown, the fixing portion 430 and the clamping portion 440 of the integrally cut and formed barbed clip after heat treatment setting may be at a certain angle, and at this time, the bending portion will have a prefabricated resilience. Through such a design, the clamping force of the barbed clip and the inner clamping arm (such as the first inner clamping arm 120 or the second inner clamping arm 130) on the tissue can be increased. It should be noted that the fixing portion 430 and the clamping portion 440 being at a certain angle can be understood as the fixing portion 430 and the clamping portion 440 not being parallel. Preferably, after heat treatment setting, the fixing portion 430 can be bent into the inner hole of the clamping portion 440 (as Figures 23 - 24 shown), that is, the flipping angle of the fixing portion 430 relative to the clamping portion 440 during the heat treatment process is greater than 180°. In some embodiments, those skilled in the art can determine the angle between the fixing portion 430 and the clamping portion 440 according to factors such as the magnitude of the required clamping force and the size of the tissue clamping device. For example, when the fixing portion 430 is bent into the inner hole of the clamping portion 440, the angle between the fixing portion 430 and the clamping portion 440 can be designed as 15°, 20°, 30°, etc.

[0073] In some embodiments, as Figure 16 shown, through holes 125 matching the barbs 450 may be provided on the inner clamping arm (such as the first inner clamping arm 120 or the second inner clamping arm 130). In some embodiments, the number of through holes 125 may be equal to the number of barbed strips (such as 4 in both cases). In some embodiments, the number of through holes 125 may also not be equal to the number of barbed strips. For example, the through hole may be a hole extending along the width direction of the inner clamping arm, and this hole can accommodate all the barbed strips. By providing the through holes 125 on the inner clamping arm, when the barbed clip is closed, the barbs 450 can just be inserted into the through holes 125 of the inner clamping arm, which can make it more convenient for the barbed clip to clamp the tissue and also make the clamping of the tissue more firm after clamping the tissue.

[0074] Figure 25 It is a schematic structural diagram of the inner clamping arm of the tissue clamping device shown in some embodiments of the present application;Figure 26 It is a schematic connection diagram of the barbed clip, inner clamping arm and fixing ring of the tissue clamping device shown in some embodiments of the present application. In some embodiments, as Figure 25 and Figure 26 shown, on the inner clamping arm (such as the first inner clamping arm 120 or the second inner clamping arm 130, taking the first inner clamping arm 120 as an example in the figure), there may be a clamping hole 121 that cooperates with the fixing part 430 of the barbed clip, and the fixing part 430 can be embedded in the clamping hole 121. Specifically, the shape of the clamping hole 121 may be the same as the shape of the fixing part 430. In some embodiments, there may also be fixing grooves 122 on the first inner clamping arm 120 and the second inner clamping arm 130, and the tissue clamping device may further include a fixing ring 460, and the fixing ring 460 can be snap-connected with the fixing groove 122 to prevent the fixing part 430 from disengaging from the clamping hole 121. Specifically, the fixing grooves 122 may be symmetrically arranged on both sides in the width direction of the inner clamping arm (as Figure 25 shown). In the actual installation process, when the clip body 100 is an integrally formed structure, the fixing ring 460 can be sleeved onto the first inner clamping arm 120 and the second inner clamping arm 130 respectively through the first outer clamping arm 150 and the second outer clamping arm 160. The fixing ring 460 can be made of an elastic material or a superelastic alloy (such as nitinol). Through the cooperation of the clamping hole 121 and the fixing part 430 and the cooperation of the fixing groove 122 and the fixing ring 460, the installation of the barbed clip can be both convenient and firm. In some alternative embodiments, after the fixing part 430 is embedded in the clamping hole 121, the fixing part 430 can be directly fixed in the clamping hole 121 by bonding or welding (such as laser welding) and other methods (for example, applying glue or welding along the gap between the fixing part 430 and the clamping hole 121). In other embodiments, the barbed clip can also be connected to the inner clamping arm by bonding, welding, riveting, threaded connection or snap connection.

[0075] In some embodiments, the fixing part 430 and the clamping part 440 of the barbed clip and the clip body 100 can be integrally formed. Figure 27 It is a schematic structural diagram of the barbed clip of the tissue clamping device integrally formed with the clip body according to some embodiments of the present application. In Figure 27In the illustrated embodiment, the fixing portion 430, the clamping portion 440, and the barbs 450 of the barb clip can all be integrally formed with the clip body 100. Specifically, when cutting the clip body 100, the shape of the clamping portion 440 and the barbs 450 of the barb clip can be cut out on the inner clamping arm of the clip body 100 (such as the first inner clamping arm 120 or the second inner clamping arm 130), and one end of the cut clamping portion 440 is still connected to the inner clamping arm (at this time, one end of the fixing portion 430 of the barb clip is also still connected to the inner clamping arm). In some embodiments, after integrally cutting out the clamping portion 440 and the barbs 450, the barbs 450 can be bent by heat treatment. In some alternative embodiments, only the clamping portion 440 can be cut out on the inner clamping arm, and barbs can be installed at the other end of the cut clamping portion 440. By integrally forming all or part of the components of the barb clip with the inner clamping arm, the connection between the barb clip and the inner clamping arm can be made more reliable, which is beneficial to improving the clamping stability of the tissue clamping device; at the same time, the assembly process of the tissue clamping device can be simplified, and the production efficiency can be improved.

[0076] In some embodiments, the tissue clamping device can include a locking mechanism 500. Figure 28 is a schematic structural view of the locking mechanism of the tissue clamping device shown in some embodiments of the present application; Figure 29 is a schematic structural view of the tissue clamping device with a locking mechanism shown in some embodiments of the present application. As Figure 28 and Figure 29 shown, the locking mechanism 500 can include a locking tube 510 and a locking member 520. One end of the locking tube 510 (such as the lower end shown in the figure) can be fixedly connected to the second connecting member 300. The outer wall of the locking tube 510 can be provided with locking fins 511, and the locking fins 511 can be used to limit the opening of the clip body. Figure 30 is a schematic structural view of the locking fins of the tissue clamping device in the retracted state shown in some embodiments of the present application; Figure 31 is a schematic structural view of the locking fins of the tissue clamping device in the open state shown in some embodiments of the present application. As Figures 30 - 31 shown, the locking fins 511 can be switched between the retracted state and the open state. The opening of the locking fins 511 faces the second connecting member 300 when it is open. Without external force, the locking fins 511 are default to be open. In some embodiments, the locking member 520 can be fixedly connected to the supporting portion 110 of the clip body. For example, the locking member 520 can be fixed in the inner cavity of the supporting portion 110 by means of gluing, welding (such as laser welding), etc. The locking fins 511 can limit the movement of the locking member 520 to limit the opening of the clip body (that is, the relative opening of the first inner clamping arm 120 and the second inner clamping arm 130). As Figure 28As shown, when the locking member 520 moves away from the second connecting member 300, the opened locking fins 511 can abut against the locking member 520 to limit the movement of the locking member 520. In some alternative embodiments, the locking fins 511 can also directly limit the opening of the clip body by restricting the movement of other parts of the clip body (such as the support portion 110). For example, the opened locking fins 511 can directly abut against the support portion 110.

[0077] In some embodiments, the locking mechanism 500 can cooperate with a first control mechanism for controlling the relative closing or opening of the first inner clamping arm 120 and the second inner clamping arm 130 to limit the relative opening of the first inner clamping arm 120 and the second inner clamping arm 130. Specifically, the other end of the locking tube 510 (such as Figure 28 the upper end shown) can be detachably connected to the brake lever 600. The brake lever 600 can control the movement of the second connecting member 300 relative to the first connecting member 200 through the locking tube 510. The locking fins 511 can limit the relative movement of the locking member 520 (or the support portion 110) and the locking tube 510 (or the second connecting member 300), thereby limiting the relative opening of the first inner clamping arm 120 and the second inner clamping arm 130. By providing the locking mechanism 500, the tissue clamping device can stably maintain the clamping state after clamping the tissue, and can effectively prevent the tissue clamping device from opening due to the impact of blood flow. It can be understood that the locking fins 511 can be used to limit the relative opening of the first inner clamping arm 120 and the second inner clamping arm 130 without restricting the closing of the first inner clamping arm 120 and the second inner clamping arm 130.

[0078] In some embodiments, the locking mechanism 500 can further include a sleeve 530. The sleeve 530 can be sleeved outside the locking tube 510 to retract the locking fins 511. Specifically, when the locking fins 511 are located inside the sleeve 530, the locking fins 511 are forced to retract. When the locking fins 511 are exposed outside the sleeve 530, the locking fins 511 automatically open. In some embodiments, the brake lever 600 of the tissue clamping device can be fixedly connected to the sleeve 530 (such as by welding, gluing, threaded connection, etc.). The brake lever 600 can be detachably connected to the locking tube 510 (such as by threaded connection). When the brake lever 600 is connected to the locking tube 510, the sleeve 530 can retract the locking fins 511. When the brake lever 600 is disengaged from the locking tube 510, the sleeve 530 releases the action on the locking fins 511, and the locking fins 511 open. As Figure 32 and Figure 33 shown, Figure 32 is a schematic structural diagram when the locking fins 511 are retracted and the locking mechanism 500 is not locked. Figure 33 is a schematic structural diagram when the locking fins 511 are open and the locking mechanism 500 is locked. In Figures 32 - 33In the illustrated embodiment, the inner hole diameter of the locking member 520 is larger than the outer diameter of the sleeve 530, and the opened locking fins 511 cannot pass through the inner hole of the locking member 520. When the brake lever 600 is connected to the locking tube 510, the sleeve 530 covers the locking fins 511 on the locking tube 510, and the locking member 520 can slide freely on the locking tube 510 and the sleeve 530. The tissue clamping device can complete the tissue clamping operation in this state. After the tissue clamping device completes the clamping of the tissue, the brake lever 600 and the sleeve 530 can be removed. At this time, the sleeve 530 releases the action on the locking fins 511, and the locking fins 511 originally located inside the sleeve 530 are exposed outside the sleeve 530 and open. The locking fins 511 can then limit the movement of the locking member 520, thereby restricting the opening of the clip body.

[0079] In some embodiments, the brake lever 600 and the locking tube 510 can be connected by threads. For example, the end of the brake lever 600 connected to the locking tube 510 can be provided with external threads, and the locking tube 510 can be correspondingly provided with internal threads. The sleeve 530 is sleeved outside the brake lever 600 and can cover the external threads of the brake lever 600. With such a setting, the brake lever 600 and the locking tube 510 can be easily disengaged. In other embodiments, the brake lever 600 and the locking tube 510 can also be detachably connected by a snap connection.

[0080] In some embodiments, the locking fins 511 can include at least two pieces, and the at least two locking fins 511 are symmetrically arranged on the outer wall of the locking tube 510 at the same distance from the second connecting member 300. It should be noted that the number of the locking fins 511 can be 2, 3, 4, etc. Two or four locking fins 511 can be arranged axially symmetrically (or centrosymmetrically) on the outer wall of the locking tube 510, and three locking fins 511 can be arranged centrosymmetrically on the outer wall of the locking tube 510 (such as spaced 120 degrees from each other). By using at least two symmetrically arranged locking fins 511 to limit the movement of the locking member 520, each locking fin 511 can be evenly stressed, thereby improving the stability of the locking mechanism 500 and extending the service life of the locking mechanism 500.

[0081] In some embodiments, the locking fins 511 may include at least two pieces, and the at least two locking fins 511 may be arranged on the outer wall of the locking tube 510 at different distances from the second connecting member 300; the at least two locking fins 511 can limit the opening of the clip body 100 when the clip body is at different opening and closing angles (such as the first inner clamp arm 120 and the second inner clamp arm 130 are relatively opened to different angles). It can be understood that when the first inner clamp arm 120 and the second inner clamp arm 130 are opened to different angles, the distance between the locking member 520 and the second connecting member 300 is different, so the locking fins 511 at different distances from the second connecting member 300 need to abut against the locking member 520 to limit the movement of the locking member 520 (support portion 110) relative to the second connecting member 300. In actual operation, due to the differences in pathological conditions and physiological structures of different patients or the differences in the clamped tissues, the opening and closing angles of the clamp body 100 of the tissue clamping device may be different after clamping the tissue and retracting it. Through such a setting, the tissue clamping device with a locking mechanism 500 can be suitable for different patients or different tissues.

[0082] In some embodiments, the locking tube 510 and the locking fin 511 may be an integrally formed structure. For example, the locking tube 510 with the locking fin 511 may be formed by cutting (such as laser cutting) a pipe fitting to form an incision. In some embodiments, the locking tube 510 and the locking fin 511 may be an integrally formed structure made by cutting and heat treating a shape memory alloy. The shape memory alloy may be a nickel-titanium alloy or a cobalt-chromium alloy, etc. After the shape memory alloy pipe is cut to form the locking fin 511 on the locking tube 510, the connection between the locking fin 511 and the locking tube 510 is heat treated and shaped so that the locking fin 511 opens outward. After heat treatment and shaping, the connection between the locking fin 511 and the locking tube 510 will have a prefabricated resilience, which can ensure that the locking fin 511 automatically opens when it is exposed outside the sleeve 530. In some alternative embodiments, the locking tube 510 and the locking fin 511 may also be two parts connected to each other. For example, the locking fin 511 may be an elastic sheet, which may be fixedly connected to the locking tube by bonding, welding (such as laser welding), etc.

[0083] In some embodiments, the tissue clamping device may include an elastic support 700. Figures 34 - 37 Schematic diagram of the structure of the elastic support of the tissue clamping device shown in various embodiments of the present application. Figures 34 - 37As shown, the elastic bracket 700 may include a first support rod 710, a second support rod 720, a first mounting portion 730, and a second mounting portion 740. One end of the first support rod 710 and the second support rod 720 may be connected to the first mounting portion 730, and the other ends of the first support rod 710 and the second support rod 720 may be connected to the second mounting portion 740. In the embodiments of the present application, the elastic bracket 700 is an integrally formed structure. That is, the first support rod 710, the second support rod 720, the first mounting portion 730, and the second mounting portion 740 are integrally formed structures. Integral forming can make the structure of the elastic bracket 700 stable, the connection of each component reliable, and the production and manufacturing simple and convenient. In some embodiments, such as Figure 1 As shown, the first mounting portion 730 and the second mounting portion 740 of the elastic bracket 700 may be fixedly connected to the second connecting member 300. That is, both ends of the first support rod 710 and the second support rod 720 are fixed to the second connecting member 300. The first support rod 710 of the elastic bracket 700 may abut against the connection portion between the first inner clamping arm 120 and the first outer clamping arm 140; the second support rod 720 of the elastic bracket 700 may abut against the connection portion between the second inner clamping arm 130 and the second outer clamping arm 150. For example, as Figure 1 shown, the first support rod 710 may abut against the inside between the first inner clamping arm 120 and the first outer clamping arm 140, and the second support rod 720 may abut against the inside between the second inner clamping arm 130 and the second outer clamping arm 150. In some embodiments, when the first support rod 710 or the second support rod 720 abuts against the inside between the inner clamping arm and the outer clamping arm, the first support rod 710 or the second support rod 720 may be further fixedly connected to the connection portion between the inner clamping arm and the outer clamping arm by means such as gluing, laser welding, or wire winding. In some alternative embodiments, the first support rod 710 may abut against the outside of the first outer clamping arm 140, and the second support rod 720 may abut against the outside of the second outer clamping arm 150. For example, the middle portion of the first support rod 710 may be fixedly connected to the outside of the first outer clamping arm (such as by gluing, laser welding, or wire winding), and the second support rod 720 may be fixedly connected to the outside of the second outer clamping arm 150. By providing the elastic bracket 700, the area of the tissue clamping device for capturing tissue can be increased, and the elastic bracket 700 has a good supporting effect on the tissue, thereby improving the stability of the tissue clamping device. At the same time, the elastic bracket 100 has a good tightening effect, so the elastic force of the elastic bracket 700 can make the clamping force on the tissue greater after the first inner clamping arm 120 and the second inner clamping arm 130 are closed. In addition, the magnitude of the elastic force provided by the elastic bracket 700 for the tissue clamping device can be adjusted according to the clamping requirements of different tissues or the tissues of different patients (such as adjusting the width of the first support rod 710 and / or the second support rod 720), so that the tissue clamping device applying the elastic bracket 700 can be applicable to different tissues or different patients.

[0084] In some embodiments, such as Figure 34As shown, the middle parts of the first support rod 710 and the second support rod 720 may respectively include a first arc segment 712, a second arc segment 714, and a third arc segment 716 that are sequentially connected; the protruding direction of the second arc segment 714 is opposite to the protruding directions of the first arc segment 712 and the third arc segment 716. Among them, the second arc segment 714 may protrude toward the second connecting member 300, and the first arc segment 712 and the third arc segment 716 may protrude in a direction away from the second connecting member 300. When the elastic bracket 700 is assembled with the clip body 100, the second arc segments 714 of the first support rod 710 and the second support rod 720 are located between the first inner clamping arm 120 and the first outer clamping arm 140, and between the second inner clamping arm 130 and the second outer clamping arm 150. Through such a design, the first support rod 710 and the second support rod 720 can better surround the support portion 110 to better wrap the tissue.

[0085] In some embodiments, as Figure 35 shown, the first support rod 710 and the second support rod 720 may have a certain width. For example, the widths of the first support rod 710 and the second support rod 720 may be greater than a set threshold. The set threshold may be 2 times, 3 times, 4 times, etc. the thickness of the support rod (such as the first support rod 710 and the second support rod 720). In some embodiments, the widths of the first support rod 710 and the second support rod 720 may be positively correlated with the elastic force provided by the elastic bracket 700 for the tissue clamping device. It can be understood that within a certain range, the wider the widths of the first support rod 710 and the second support rod 720, the greater the elastic force provided by the elastic bracket 700 for the tissue clamping device, and the greater the clamping force of the tissue clamping device on the tissue. In some embodiments, elastic brackets 700 with different widths may be selected according to the clamping requirements of different tissues or tissues of different patients. In some embodiments, the widths of the respective segments of the first support rod 710 and the second support rod 720 may be different, so as to further adjust the elastic force provided by the elastic bracket 700 for the tissue clamping device.

[0086] In some embodiments, as Figure 36 shown, one end of the first support rod 710 and the second support rod 720 may be connected to the first mounting portion 730 through an S-rod bending structure 910; the other end of the first support rod 710 and the second support rod 720 may be connected to the second mounting portion 740 through the S-rod bending structure 910. The S-rod bending structure 910 may at least include three straight rods 911 and two bent rods 912, and the three straight rods 911 are parallel to each other and the three straight rods 911 are connected end to end through the two bent rods 912. For more details about the S-rod bending structure 910, reference may be made to Figures 8 - 10 and its related description. By providing an S-rod bending structure at the end of the support rod to connect with the mounting portion, the elastic bracket 700 (such as the end of the support rod) can be easily deformed during heat treatment.

[0087] In some embodiments, as Figure 37 shown, one end of the first support rod 710 and the second support rod 720 can be connected to the first mounting portion 730 through the first connecting portion 750; the other ends of the first support rod 710 and the second support rod 720 can be connected to the second mounting portion 740 through the second connecting portion 760; through holes can be provided on the first connecting portion 750 and the second connecting portion 760. The number of the through holes can include one or more. The shape of the through holes can include but is not limited to strip-shaped, square, circular, rectangular, etc. By providing through holes on the first connecting portion 750 and the second connecting portion 760, the elastic support 700 (such as the ends of the support rods) can be easily deformed during heat treatment.

[0088] In some embodiments, the elastic support 700 can be an integrally formed structure made by cutting and heat-treating a shape memory alloy tube. The shape memory alloy can be a nickel-titanium alloy or a cobalt-chromium alloy, etc. Preferably, the material of the elastic support 700 can be a superelastic metal (such as a nickel-titanium alloy). Figure 38 is a top view of the elastic support shown in some embodiments of the present application. As can be seen from Figure 33 it, Figure 38 the elastic support 700 in Figure 37 is cut from a shape memory alloy tube. Similarly, Figures 34 - 36 the elastic support 700 shown in Figure 39 is also integrally cut and formed from a shape memory alloy tube. After cutting the elastic support 700 from the shape memory alloy tube, the elastic support 700 can be further heat-treated. Figure 37 is a schematic structural diagram of the elastic support after heat treatment shown in some embodiments of the present application. As Figure 39 shown, after heat treatment and shaping, the first mounting portion 730 and the second mounting portion 740 can be relatively closed together to facilitate the installation of the elastic support 700 onto the second connecting member 300. At the same time, the first support rod 710 and the second support rod 720 after heat treatment have a pre-set resilience. After the elastic support 700 is installed onto the second connecting member 300 and assembled with the clip body 100, when the first inner clip arm 120 and the second inner clip arm 130 clamp the tissue and close together, the pre-set resilience of the first support rod 710 and the second support rod 720 can cause the first inner clip arm 120 and the second inner clip arm 130 to further clamp the tissue, thereby making the tissue clamping device more stable.

[0089] Figure 40 is a schematic structural diagram of the first connecting member of the tissue clamping device shown in some embodiments of the present application; Figure 41 is a connection schematic diagram of the first connecting member of the tissue clamping device and the clip body shown in some embodiments of the present application. As Figures 40 - 41As shown, an installation bayonet 202 may be provided inside the first connecting member 200, and one end (such as the upper end shown in Figure 41 ) of the support portion 110 of the clip body 100 may be inserted and fixed into the installation bayonet 202. In addition, a through hole 204 for the brake lever 600 to pass through may be provided on the first connecting member 200. A bump 206 for the snap connection of the conveying connecting member 800 may be provided on the side wall of the first connecting member 200. In some embodiments, after one end of the support portion 110 is inserted into the installation bayonet 202, the support portion 110 and the first connecting member 200 may be fixedly connected by a pin shaft. In some embodiments, after one end of the support portion 110 is inserted into the installation bayonet 202, the support portion 110 and the first connecting member 200 may also be fixedly connected by means of gluing, welding, etc.

[0090] Figure 42 FIG. is a schematic diagram of the connection structure between the tissue clamping device and the conveying assembly according to some embodiments of the present application. As shown in Figure 2 and Figure 42 , the first connecting member 200 may be connected to the conveying connecting member 800 of the conveying assembly so that the tissue clamping device can be sent to a predetermined position by the conveying assembly. After the tissue clamping device clamps the tissue, the conveying connecting member 800 of the conveying assembly may be disengaged from the tissue clamping device so that the conveying assembly can be withdrawn, while the tissue clamping device remains in the body.

[0091] As shown in Figure 42 , the conveying connecting member 800 may include a main body 810, a first connecting piece 820 and a second connecting piece 830. Wherein, the connection parts of the first connecting piece 820 and the second connecting piece 830 with the main body 810 may have a prefabricated resilience, and this prefabricated resilience can make the first connecting piece 820 and the second connecting piece 830 automatically open in the natural state. A fixing strut 840 may also be provided in the middle of the first connecting piece 820 and the second connecting piece 830. The fixing strut 840 is perpendicular to the first connecting piece 820 and 830, and a through hole for the brake lever 600 to pass through is provided at the suspended end of the fixing strut 840. As shown in Figure 2 and Figure 42As shown, when the delivery connector 800 is connected to the first connector 200 of the tissue clamping device, the first connecting piece 820 and the second connecting piece 830 are relatively closed and respectively clamped with the bumps 206 on the first connector 200. At this time, the brake rod 600 can pass through the through hole on the fixed support rod 840 connected to the first connecting piece 820 and the second connecting piece 830. At this time, the brake rod 600 will limit the opening of the first connecting piece 820 and the second connecting piece 830. When it is necessary to disconnect the delivery assembly from the tissue clamping device, the connection between the brake rod 600 and the tissue clamping device can be released first and the brake rod 600 can be retracted, so that the brake rod 600 disengages from the through hole on the fixed support rod 840 connected to the first connecting piece 820 and the second connecting piece 830, so that the first connecting piece 820 and the second connecting piece 830 automatically open and disengage from the clamping connection with the bumps 206 on the first connector 200. In some embodiments, the delivery connector 800 can be an integrally formed structure made of a shape memory alloy tube after cutting and heat treatment for shaping. Specifically, during the heat treatment process, the first connecting piece 820 and the second connecting piece 830 of the delivery connector 800 can be bent relative to the main body 810 so that the joints between the first connecting piece 820 and the second connecting piece 830 and the main body 810 have a prefabricated resilience. In addition, the fixed support rod 840 can also be bent during the heat treatment process so that it is perpendicular to the first connecting piece 820 or the second connecting piece 830.

[0092] Figure 43 is a schematic structural view of the second connector of the tissue clamping device according to some embodiments of the present application; Figure 44 is a schematic connection view of the clip body and the second connector according to some embodiments of the present application; Figure 45 is a schematic structural view of the second connector of the tissue clamping device according to another embodiment of the present application; Figure 46 is a schematic connection view of the clip body and the second connector according to another embodiment of the present application. As Figures 43 - 46 shown, a connection hole 302 (such as a threaded hole) for detachably connecting with the brake rod 600 can be provided at the center of the second connector 300. In some embodiments, as Figures 43 - 44 shown, mounting holes 304 for installing the first mounting portion 730 and the second mounting portion 740 for the first outer clamping arm 140, the second outer clamping arm 150, and the elastic bracket 700 can be provided around the connection hole. As Figure 44As shown, one end (the lower end shown in the figure) of the first outer clamping arm 140 can be inserted into one of the mounting holes 304 of the second connecting member 300 and fixedly connected to the second connecting member 300. Additionally, one end of the second outer clamping arm 150 can also be inserted into the other mounting hole 304 of the second connecting member 300 and fixedly connected to the second connecting member 300. The ways of fixedly connecting one end of the first outer clamping arm 140 and one end of the second outer clamping arm 150 to the second connecting member 300 can include gluing, welding, snap - fitting, etc. from the inside or the bottom end (the lower end shown in the figure) of the mounting hole 304. In some embodiments, as Figures 45 - 46 shown, bumps 306 for mounting the first mounting portion 730 and the second mounting portion 740 of the first outer clamping arm 140, the second outer clamping arm 150, and the elastic bracket 700 can be provided on the side wall of the second connecting member 300. As Figure 46 shown, one end (the lower end shown in the figure) of the first outer clamping arm 140 can be snap - fitted with one of the bumps 306 of the second connecting member 300 and fixedly connected to the second connecting member. The ways of fixedly connecting one end of the first outer clamping arm 140 to the second connecting member 300 can include gluing, welding, etc. In some embodiments, when the four bumps 306 on the side wall of the second connecting member 300 are respectively snap - fitted with the first mounting portion 730 and the second mounting portion 740 of the first outer clamping arm 140, the second outer clamping arm 150, and the elastic bracket 700, a fixing sleeve can be put on the outside of the second connecting member 300, so as to effectively prevent each component from detaching from the bump 306. Among them, the fixing sleeve can be fixedly connected to the second connecting member 300 by welding, gluing, etc. In some alternative embodiments, when the tissue clamping device includes a locking mechanism 500, a connection hole for fixedly connecting to the locking tube can be provided at the center of the second connecting member 300.

[0093] In some embodiments, the tissue clamping device can be controlled by a control handle, and the control handle can be connected to the tissue clamping device through a conveying assembly. Specifically, the control handle can include a brake rod control mechanism and a clip control mechanism. The brake rod control mechanism can be used to control the telescoping and rotation of the brake rod 600. The clip control mechanism can be used to control the opening and closing of the first clip 410 and the second clip 420 relative to the first inner clamping arm 120 and the second inner clamping arm 130 respectively.

[0094] In some embodiments, the usage method of the tissue clamping device of the present application can include the following steps:

[0095] (1) Send the tissue clamping device to a predetermined position through the conveying assembly;

[0096] (2) Control the movement of the second connecting member 300 relative to the first connecting member 200 through the brake rod 600, so that the first inner and outer arms 120 and the second inner clamping arm 130 are relatively opened to an appropriate angle;

[0097] (3) Control the first clamping piece 410 and the second clamping piece 420 to open and close relative to the first inner clamping arm 120 and the second inner clamping arm 130 respectively (such as through the first traction cable and the second traction cable), so that the tissue is clamped between the first clamping piece 410 and the first inner clamping arm 120 and between the second clamping piece 420 and the second inner clamping arm 130;

[0098] (4) Control the second connecting piece 300 to move relative to the first connecting piece 200, so that the first inner clamping arm 120 and the second inner clamping arm 130 are relatively closed;

[0099] (5) Control the brake lever 600 and the conveying assembly to disengage from the tissue clamping device. At this time, if the tissue clamping device includes a locking mechanism 500, the locking fins 511 on the locking tube 510 will open outwards to limit the relative opening of the first inner clamping arm 120 and the second inner clamping arm 130.

[0100] For example, when using the tissue clamping device to clamp the mitral valve to treat mitral regurgitation, the tissue clamping device can be sent to the mitral valve through the left atrium, and then the second connecting piece 300 is controlled to move relative to the first connecting piece 200 through the brake lever 600, so that the first inner clamping arm 120 and the second inner clamping arm 130 of the clip body 100 are opened to an appropriate angle (such as 120°, 150°, 180°, etc.); and the first clamping piece 410 and the second clamping piece 420 are controlled to open relative to the first inner clamping arm 120 and the second inner clamping arm 130 respectively. Further adjust the position of the tissue clamping device so that the first inner clamping arm 120 and the second inner clamping arm 130 are located on the left ventricular side of the mitral valve, and the first inner clamping arm 120 and the second inner clamping arm 130 capture the mitral valve; then control the first clamping piece 410 and the second clamping piece 420 to close relative to the first inner clamping arm 120 and the second inner clamping arm 130 respectively, so that the mitral valve can be clamped between the first inner clamping arm 120 and the first clamping piece 410 and between the second inner clamping arm 130 and the second clamping piece 420; then control the first inner clamping arm 120 and the second inner clamping arm 130 of the clip body 100 to close through the brake lever 600, and the operation of clamping the mitral valve by the tissue clamping device is completed, and a large hole between the mitral valves becomes two small holes. Then control the brake lever 600 and the conveying assembly to disengage from the tissue clamping device, and the brake lever 600 and the conveying assembly can be withdrawn from the human body. In addition, when the tissue clamping device has a locking mechanism 500, when the brake lever 600 is disengaged from the locking tube 510, the locking fins 511 of the locking mechanism 500 automatically open to limit the opening of the first inner clamping arm 120 and the second inner clamping arm 130 of the clip body 100, so as to avoid the tissue clamping device being disengaged from the mitral valve due to the impact of blood flow and other reasons.

[0101] The beneficial effects that the tissue clamping device disclosed in this application may bring include, but are not limited to: (1) One or more components of the tissue clamping device can be an integrally formed structure, which can make the structure of the tissue clamping device stable, the connection reliable, and the production and manufacturing simple and convenient; (2) Through the bendable connection between the inner clamping arm and the support part, and the bendable connection between the inner clamping arm and the outer clamping arm, the inner clamping arm of the clip body of the tissue clamping device can be flexibly closed or opened to better complete the work of tissue capture and clamping; (3) Through the ingenious design of the bending structure, relevant components can be easily heat-treated and deformed, and a stable bending effect between components can be achieved; (4) By setting barbed clip pieces, it can prevent the tissue from slipping out between the clip pieces and the inner clamping arm, thereby improving the clamping stability of the tissue clamping device; (5) The locking mechanism can limit the opening of the inner clamping arm of the tissue clamping device after the tissue clamping device clamps the tissue, making the clamping of the tissue by the tissue clamping device more stable; (6) By setting an elastic bracket, not only can the tissue be more easily captured by the first inner clamping arm and the second inner clamping arm, but also the tissue can be protected and the clamping stability of the tissue clamping device can be improved. It should be noted that the beneficial effects that may be produced by different embodiments are different. In different embodiments, the beneficial effects that may be produced can be any one or several combinations of the above, or any other beneficial effects that may be obtained.

[0102] The above are only the preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of this application shall be included in the protection scope of this application.

Claims

1. The clip body of a tissue clamping device, characterized in that, The clip body includes a support portion, a first inner clip arm, a first outer clip arm, a second inner clip arm, and a second outer clip arm. One side of the support portion is sequentially and bendably connected to the first inner clip arm and the first outer clip arm, and the other side of the support portion is sequentially and bendably connected to the second inner clip arm and the second outer clip arm. The clip body is an integrally formed structure. The first outer clip arm and the second outer clip arm are bent and deformed into an arc shape along the length direction. The first outer clip arm and the second outer clip arm include a plurality of through holes, and the plurality of through holes can assist the deformation of the first outer clip arm and the second outer clip arm during the heat treatment process. Each through hole can extend along the width direction of the first outer clip arm and the second outer clip arm, and the plurality of through holes are arranged at intervals along the length direction of the first outer clip arm and the second outer clip arm.

2. The clip body of the tissue clamping device according to claim 1, characterized in that, One side of the support portion is connected to the first inner clip arm through a first bending structure; the other side of the support portion is connected to the second inner clip arm through a first bending structure; The first inner clip arm is connected to the first outer clip arm through a second bending structure; the second inner clip arm is connected to the second outer clip arm through a second bending structure.

3. The clip body of the tissue clamping device according to claim 2, wherein, The first bending structure is an S-bar bending structure or a narrow-waist bending structure; The second bending structure is an S-bar bending structure or a narrow-waist bending structure.

4. The clip body of the tissue clamping device according to claim 3, characterized in that, The S-bar bending structure includes at least three straight bars and two bent bars, and the three straight bars are parallel to each other and the three straight bars are connected end to end through the two bent bars.

5. The clip body of the tissue clamping device according to claim 1, characterized in that, The support portion is a grid structure; the grid structure includes a diamond grid, a circular grid, or a triangular grid.

6. The clip body of the tissue clamping device according to claim 1, characterized in that, The cross-sectional shape of the support portion is circular or oval; The cross-sectional area in the middle of the support portion is larger than the cross-sectional areas at both ends thereof.

7. The clip body of the tissue clamping device according to claim 1, characterized in that, The first inner clip arm and the second inner clip arm include barbs clip pieces formed by integral cutting.

8. The clip body of the tissue clamping device according to claim 1, wherein, The clip body is an integrally formed structure made of a shape memory alloy tube after cutting and heat treatment shaping.

9. The clip body of the tissue clamping device according to claim 1, characterized in that, The support portion is a grid structure; the grid structure includes a rectangular grid.

10. The clip body of the tissue clamping device according to claim 1, characterized in that, The support portion is a grid structure; the grid structure includes a square grid.

11. The clip body of the tissue clamping device according to claim 1, characterized in that, The support portion is a grid structure; the grid structure includes a regular polygon grid.

12. An organization clamping device, characterized in that, It includes the clip body according to any one of claims 1-11.

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