A mitral valve leaflet cutting device and system

Abstract

The utility model relates to a kind of mitral valve leaflet cutting device and system, the device includes: remote control, remote control is equipped with the guide groove of inclination extension along axial direction;Main body, the distal end of main body is fixed with remote control;Clamping arm, the distal end of clamping arm is equipped with limit boss, limit boss is slidably matched in guide groove, the proximal end of clamping arm is used to clamp and fix mitral valve leaflet;Moving part, moving part is slidably set on the outer periphery of main body, its distal end is pivotally connected with clamping arm, the axial movement of moving part is used to drive limit boss to move along guide groove, so that clamping arm can rotate around the pivot joint of it and main body, to realize opening and closing;Tool bit, tool bit is axially movably arranged in main body, tool bit can reciprocate along the axial direction of main body when clamping arm fixes mitral valve leaflet, to cut mitral valve leaflet.

Description

Technical Field

[0001] This utility model relates to the field of medical devices for cardiac surgery, and in particular to a mitral valve leaflet cutting device and system. Background Technology

[0002] With the development of minimally invasive surgical techniques, transcatheter mitral valve replacement (TMVR) and valve-in-valve techniques have revolutionized the treatment of mitral regurgitation. However, due to the complex and fragile structure of the left ventricle, the use of excessively large bioprosthetic valves with stents or high-stent mechanical valves during the procedure can affect the ejection function of the left ventricular outflow tract, leading to postoperative left ventricular outflow tract obstruction (LVOTO). These complications have hindered the development of transcatheter mitral valve treatment to some extent.

[0003] To address this issue, the LAMPOON technique was developed, a pre-treatment technique used to prevent left ventricular outflow tract obstruction after transcatheter mitral valve replacement. This technique involves pre-cutting the anterior leaflet of the mitral valve so that it can separate from the new valve after implantation, thereby maintaining a patent outflow tract.

[0004] During the LAMPOON technique, two guiding catheters are first inserted retrogradely into the left ventricular outflow tract and the left atrium, respectively, to the sides of the anterior mitral valve leaflet. Then, a guidewire is energized and passed through the center and base of the anterior mitral valve leaflet, and pushed into the snare. The guidewire forms a tear surface on the anterior mitral valve leaflet. During the energization process, the catheters and guidewire are pulled, tearing the anterior mitral valve leaflet along the midline.

[0005] Studies have shown that the LAMPOON technique has a high success rate and can effectively reduce the incidence of left ventricular outflow tract obstruction; however, the technique still has some limitations: it requires the use of multiple access catheters, the operation process is complex, the physician training period is long, and the cost of use is high... These factors limit the further promotion and application of the technique.

[0006] Therefore, there is an urgent need to develop a simple and easy-to-operate mitral valve leaflet cutting device to better solve the problem of left ventricular outflow tract obstruction after transcatheter mitral valve replacement. Utility Model Content

[0007] This utility model discloses a mitral valve leaflet cutting device and system, which aims to solve the technical problems existing in the prior art.

[0008] The present invention adopts the following technical solution:

[0009] On the one hand, this utility model provides a mitral valve leaflet cutting device, comprising:

[0010] - Remote control unit, the remote control unit is provided with a guide groove that extends obliquely along the axial direction;

[0011] -Main body, the far end of the main body is fixedly connected to the far end control component;

[0012] - Clamping arm, the distal end of the clamping arm is provided with a limiting boss, the limiting boss is slidably fitted in the guide groove, and the proximal end of the clamping arm is used to clamp and fix the mitral valve leaflets.

[0013] - The movable part is axially slidably sleeved on the outer periphery of the main body, and its distal end is pivotally connected to the clamping arm. The axial movement of the movable part is used to drive the limiting boss to move along the guide groove, so that the clamping arm can rotate around its pivot point with the main body to realize opening and closing.

[0014] - The cutter head is axially movable within the main body. The cutter head can reciprocate along the axis of the main body when the clamping arm fixes the mitral valve leaflets to cut the mitral valve leaflets.

[0015] As a preferred technical solution, there is a preset angle between the axial projection of the guide groove and the axis of the remote control component, and the preset angle is positively correlated with the opening rate of the clamping arm.

[0016] The length of the guide groove and / or the preset angle are positively correlated with the opening angle of the clamping arm.

[0017] As a preferred technical solution, the proximal end of the remote control component is provided with a first hidden part for accommodating and restricting the movement of the cutter head. The proximal end of the first hidden part is open, the distal end of the first hidden part is closed, and the height of the first hidden part is greater than the height of the cutter head.

[0018] As a preferred technical solution, the remote control component has a first fixing part at its internal remote end, and the main body component has a second fixing part at its remote end. The contours of the first fixing part and the second fixing part match, and the two are fixedly connected.

[0019] As a preferred technical solution, the main body also includes an axially extending guide portion, which passes through the moving part;

[0020] The guide part has an axially extending limiting slider on its outer periphery, and the moving part has a limiting groove on its inner side. The limiting groove and the limiting slider match each other to limit the circumferential rotation of the moving part.

[0021] As a preferred technical solution, the guide section is provided with an axially extending cutter guide groove to accommodate the axial movement of the cutter head.

[0022] As a preferred technical solution, the cutter head is provided with double-sided cutting edges that extend obliquely to the distal end. The double-sided cutting edges include an outer cutting edge and an inner cutting edge, with the cutting edge of the outer cutting edge facing the proximal end and the cutting edge of the inner cutting edge facing the distal end.

[0023] As a preferred technical solution, the proximal end of the cutter head is fixedly connected to the control rod, which is used to control the axial movement of the cutter head.

[0024] As a preferred technical solution, the proximal end of the moving part is provided with a second hidden part for accommodating and restricting the movement of the cutter head. The distal end of the second hidden part is open, the proximal end of the second hidden part is closed, the height of the second hidden part is greater than the height of the cutter head, and the length of the second hidden part is not less than the length of the cutter head.

[0025] As a preferred technical solution, the moving part is provided with a cutting groove in the middle, and the side of the cutting groove is open and can expose the cutting head, so that when the cutting head moves in the cutting groove, the cutting operation of the mitral valve leaflets can be realized.

[0026] As a preferred technical solution, the cutting groove is provided with barbed structures on both sides, and the clamping arm is also provided with barbed structures on both sides of the proximal end. The barbed structures are used to clamp and fix the mitral valve leaflets.

[0027] As a preferred technical solution, the outer contour of the clamping arm is configured such that when the clamping arm is in the closed state, the outer surface of the clamping arm, the outer contour of the cutting groove, and the outer contour of the remote control component are all located on the same cylindrical surface.

[0028] As a preferred technical solution, the proximal end of the clamping arm is provided with a convex head, which gradually narrows along the proximal direction. The convex head can guide the chordae tendineae to slide to both sides when clamping the mitral valve leaflets, so as to avoid damage to the chordae tendineae, while preserving the original shape of the mitral valve.

[0029] As a preferred technical solution, the two sides of the clamping arm are also provided with arc-shaped grooves. The curvature of the grooves extends along the axial direction of the clamping arm, and the grooves are used to increase the volume of the mitral valve leaflets that can be clamped.

[0030] As a preferred technical solution, it also includes a catheter portion and a handle portion;

[0031] The catheter section is provided with a middle sheath and an inner sheath. The middle sheath is sleeved outside the inner sheath, and the two can move axially relative to each other. The distal end of the middle sheath is fixedly connected to the proximal end of the moving part, and the distal end of the inner sheath is fixedly connected to the proximal end of the main body.

[0032] The handle is connected to the proximal end of the guide tube and is used to control the axial movement of the middle sheath, inner sheath, and cutter head.

[0033] On the other hand, the present invention also provides a mitral valve leaflet cutting system, including the mitral valve leaflet cutting device as described in any of the preceding claims, wherein the mitral valve leaflet cutting system further includes at least an outer sheath.

[0034] The technical solution adopted in this utility model can achieve the following beneficial effects:

[0035] This utility model mainly provides a mitral valve leaflet cutting device. The device includes a remote control component, a main body component, a clamping arm, a moving component, and a cutting head. The remote control component is fixedly connected to the main body component. By axially pulling the moving component, the clamping arm can be rotated to clamp the mitral valve leaflet. Then, by pulling the cutting head, the mitral valve leaflet can be cut.

[0036] The distal control unit features a guide groove extending obliquely along the axial direction, allowing for precise control of the opening and closing angle of the clamping arm. This oblique angle matches the anatomical structure of the mitral valve leaflets, improving leaflet capture efficiency. The proximal end of the clamping arm has a convex head that gradually narrows proximally, effectively guiding the chordae tendineae to slide laterally, avoiding damage and preserving the original morphology of the mitral valve. The arc-shaped grooves on both sides of the clamping arm increase the volume of mitral valve leaflets that can be clamped, accommodating leaflet tissue of varying thicknesses and improving the device's adaptability. Furthermore, the blade of this invention employs a double-edged structure extending obliquely distally, with the outer blade facing proximally and the inner blade facing distally, enabling efficient reciprocating cutting of the leaflets.

[0037] This invention further provides a mitral valve leaflet cutting system, which, in addition to the aforementioned mitral valve leaflet cutting device, is further provided with an external sheath to facilitate the introduction of the aforementioned mitral valve leaflet cutting device into the heart via a vascular access. Attached Figure Description

[0038] To more clearly illustrate the technical solutions of the embodiments of this utility model, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of this utility model. The illustrative embodiments of this utility model and their descriptions explain this utility model and do not constitute an improper limitation of this utility model. In the accompanying drawings:

[0039] Figure 1 This is a schematic diagram of the mitral valve leaflet cutting device in one embodiment of the present invention when the clamping arm is closed.

[0040] Figure 2 This is a schematic diagram of the mitral valve leaflet cutting device in one embodiment of the present invention when the clamping arm is open.

[0041] Figure 3 This is a schematic diagram of the structure of the remote control component in one embodiment of the present invention (Example 1).

[0042] Figure 4 This is a cross-sectional view of a remote control component in one embodiment of the present utility model, as disclosed in Embodiment 1.

[0043] Figure 5 This is a schematic diagram of the main component in one embodiment of the present utility model;

[0044] Figure 6 This is a perspective view of the main component in one embodiment of the present utility model;

[0045] Figure 7 This is a cross-sectional view of the main component in one embodiment of the present utility model, as disclosed in Embodiment 1.

[0046] Figure 8 This is a schematic diagram of the blade structure in one embodiment of the present invention, as disclosed in Embodiment 1.

[0047] Figure 9 This is a schematic diagram of the structure of the movable component in one embodiment of the present utility model;

[0048] Figure 10 This is a cross-sectional view of the movable component in one embodiment of the present utility model, as disclosed in Embodiment 1.

[0049] Figure 11 This is a perspective view of the clamping arm in one embodiment of the present utility model, as disclosed in Embodiment 1.

[0050] Figure 12 This is a schematic diagram of the clamping arm in one embodiment of the present invention.

[0051] Explanation of reference numerals in the attached figures:

[0052] Remote control component 10, guide groove 11, first fixing part 12, first hidden part 13, main body 20, second fixing part 21, guide part 22, limiting slider 221, cutter head guide groove 222, clamping arm 30, limiting boss 31, pivot point 32, protruding head 33, groove part 34, moving part 40, limiting slide 41, second hidden part 42, cutting groove 43, cutter head 50, outer cutting edge 51, inner cutting edge 52, control rod 53, barb structure 60. Detailed Implementation

[0053] To make the objectives, technical solutions, and advantages of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this utility model, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly stated otherwise.

[0054] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance. The term "proximal end" refers to the end closer to the operator along the length direction of the mitral valve leaflet cutting device; the term "distal end" refers to the end farther from the operator along the length direction of the mitral valve leaflet cutting device.

[0055] Those skilled in the art will understand that, in order to achieve their respective functions and meet the requirements of surgical procedures, the specific shape, size, angle, etc., of each structure can be adaptively adjusted. Obviously, the described embodiments are only a part of the embodiments of this utility model, and not all of them. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this utility model.

[0056] Example 1

[0057] This embodiment provides a mitral valve leaflet cutting device, which is preferably used before performing transcatheter mitral valve replacement or valve-in-valve technology to cut the mitral valve, so as to prevent the implanted artificial valve from pushing the original leaflet (anterior leaflet of the mitral valve) towards the left ventricular outflow tract wall, causing stenosis or obstruction of the left ventricular outflow tract.

[0058] refer to Figure 1 — Figure 12 The mitral valve leaflet cutting device includes a distal control component 10, a main body component 20, a moving component 40, a clamping arm 30, and a cutting head 50. All of these components are located at the distal end of the device. The distal end of the main body component 20 is fixedly connected to the distal control component 10. The distal control component 10 has a guide groove 11 extending obliquely along the axial direction. The distal end of the clamping arm 30 has a limiting boss 31, which slides within the guide groove 11. The proximal end of the clamping arm 30 is used to clamp and fix the mitral valve leaflet. The leaflet; the movable part 40 is axially slidably sleeved on the outer periphery of the main body 20, and its distal end is pivotally connected to the clamping arm 30. The axial movement of the movable part 40 can drive the limiting boss 31 to move along the guide groove 11, so that the clamping arm 30 rotates around its pivot point 32 with the main body 20 to realize opening and closing; the cutter head 50 is axially movable and disposed in the main body 20. When the clamping arm 30 fixes the mitral valve leaflet, the cutter head 50 can reciprocate along the axial direction of the main body 20 to cut the mitral valve leaflet.

[0059] In some embodiments, the mitral valve leaflet cutting device further includes a conduit portion comprising an inner sheath and a middle sheath, which are axially movable relative to each other. The distal end of the middle sheath is fixedly connected to the proximal end of the moving member 40, and the distal end of the inner sheath is fixedly connected to the proximal end of the main body 20. During operation, simultaneously delivering the inner and middle sheaths distally allows the entire device to move distally; keeping the inner sheath fixed in position while axially moving the middle sheath allows the moving member 40 to move back and forth, thereby driving the clamping arm 30 to open and close, thereby clamping and fixing the mitral valve leaflets. Preferably, before the device is implanted, the movable member 40 is located at the distal end to ensure that the clamping arm 30 is in a closed state; when cutting the mitral valve leaflets, the movable member 40 is pulled proximally by operating the middle sheath to open the clamping arm 30, so that the mitral valve leaflets fall between the clamping arm 30 and the movable member 40, and then the middle sheath is pushed distally to close the clamping arm 30 and clamp the mitral valve leaflets.

[0060] In some embodiments, the mitral valve leaflet cutting device also includes a handle portion connected to the proximal end of the catheter portion for controlling the axial movement of the middle sheath and inner sheath; a control rod 53 is connected to the proximal end of the cutter head 50 for controlling the axial movement of the cutter head 50, and the proximal end of the control rod 53 also extends axially into the handle portion, thereby achieving its cutting function by controlling the movement of the cutter head 50.

[0061] In this embodiment, the specific structure of the handle is not limited. Those skilled in the art can choose any applicable handle structure in the prior art, as long as it can achieve axial movement control of the middle sheath, inner sheath, and control rod 53. For example, the handle may include a first operating member for controlling the movement of the middle sheath, a second operating member for controlling the movement of the inner sheath, and a third operating member for controlling the movement of the cutter head 50. The three operating members can operate independently of each other to achieve the various functions of the device.

[0062] refer to Figure 3 , Figure 4 In some embodiments, the remote control member 10 is generally cylindrical, with an open proximal end and a closed distal end, and the main body member 20 is an axially extending rod-shaped member; a first fixing part 12 is provided at the distal end inside the remote control member 10, and a second fixing part 21 is provided at the distal end of the main body member 20. The contours of the first fixing part 12 and the second fixing part 21 match, and the two are fixedly connected.

[0063] In some embodiments, the first fixing part 12 is configured as an annular groove on the inner wall of the remote control member 10, and the second fixing part 21 is configured as an annular protrusion at the distal end of the main body member 20. The two parts can be fitted together and fixed by adhesive bonding. This fitting structure of the annular groove and the annular protrusion ensures the coaxiality between the remote control member 10 and the main body member 20, preventing eccentricity during fixing. In addition, the fitting and adhesive bonding connection method also ensures a high connection strength between the remote control member 10 and the main body member 20, preventing separation during use.

[0064] In other embodiments, the first fixing part 12 and the second fixing part 21 may also adopt other forms of mating structure, such as fixing by threaded connection, snap-fit ​​connection, etc., as long as a stable connection between the remote control part 10 and the main body part 20 can be guaranteed.

[0065] refer to Figure 5 — Figure 7 In some embodiments, the main body 20 further includes an axially extending guide portion 22, which has an axially extending blade guide groove 222 for accommodating the axial movement of the blade 50. When the blade 50 reciprocates within the blade guide groove 222, its cutting edge can extend through the open area of ​​the blade guide groove 222 and contact the mitral valve leaflet fixed by the clamping arm 30, thereby achieving cutting. Specifically, the width of the blade guide groove 222 is slightly larger than the width of the blade 50, allowing the blade 50 to reciprocate smoothly within it.

[0066] like Figure 8 In some embodiments, the cutter head 50 is provided with double-sided cutting edges that extend obliquely to the distal end for reciprocating cutting of the mitral valve leaflets.

[0067] In some embodiments, the dual-blade system includes an outer blade 51 and an inner blade 52, with the edge of the outer blade 51 facing proximally and the edge of the inner blade 52 facing distally. When the blade head 50 advances distally, the inner blade 52 operates, enabling it to cut from the contralateral edge of the leaflet; when the blade head 50 retracts proximally, the outer blade 51 operates, enabling it to cut from the root of the leaflet. This reciprocating cutting mechanism not only improves cutting efficiency but also reduces the force of a single cut, making the surgical procedure smoother and safer, and reducing the risk of accidental damage to other cardiac structures.

[0068] In some embodiments, when the valve is closed, the mitral valve leaflets exhibit an arc shape oriented towards the left ventricle. The distally extending, obliquely extending bilateral blades allow the blade tip 50 to better adapt to the natural curvature of the mitral valve leaflets, resulting in a closer fit of the cutting surface to the leaflet surface and improved cutting precision. Furthermore, the obliquely extending structure also reduces the tensile force on the chordae tendineae during cutting, lowering the risk of chordae tendineae rupture and preventing postoperative complications such as valve prolapse.

[0069] In some embodiments, the outer blade 51 is set at a first tilt angle relative to the axis of the control lever 53, the first tilt angle causing the cutting edge of the outer blade 51 to tilt outward from the axis of the control lever 53; the inner blade 52 is set at a second tilt angle relative to the axis of the control lever 53, the second tilt angle causing the cutting edge of the inner blade 52 to tilt outward from the axis of the control lever 53; the first tilt angle and the second tilt angle can be the same or different, and can be adjusted and selected according to the valve lesion, and are not specifically limited in this embodiment. By adjusting the first tilt angle and the second tilt angle, the two blades can be adapted to the cutting needs of different directions and positions, and can also adapt to valve leaflet tissues of different thicknesses and hardnesses.

[0070] In some embodiments, the height of the blade head 50 is configured such that, when the clamping arm 30 is in the closed state, it is less than the distance between the control lever 53 and the inner side of the clamping arm 30. This height ensures that when the clamping arm 30 needs to close to clamp the mitral valve leaflets, the blade head 50 will not form a physical obstacle, allowing the clamping arm 30 to close smoothly and completely, thereby firmly fixing the mitral valve leaflet tissue.

[0071] like Figure 4 In some embodiments, the proximal end of the distal control member 10 is provided with a first hidden portion 13 for accommodating and restricting the movement of the cutter head 50; preferably, the first hidden portion 13 extends axially a short distance from the proximal end of the distal control member 10 in the proximal direction to form a cavity space, the proximal end of which is open so as to communicate with the cutter head guide groove 222 inside the main body 20, while the distal end is closed to form a physical barrier, so that the first hidden portion 13 can provide a limiting protection when the cutter head 50 is pushed to the distal end, preventing damage to the distal control member 10 that may be caused by excessive pushing of the cutter head 50.

[0072] Furthermore, the height of the first hidden part 13 is configured to be greater than the height of the cutter head 50, so as to ensure that when the cutter head 50 is fully advanced to the far end, it can be fully accommodated by the first hidden part 13 and will not rub or collide with the inner wall of the far end control member 10, thereby avoiding damage to the cutter head 50 or the structure of the far end control member 10; at the same time, it is also convenient for the cutter head 50 to be stably positioned in the first hidden part 13, reducing lateral shaking and improving cutting accuracy.

[0073] like Figure 10 Correspondingly, in some embodiments, the proximal end of the movable member 40 is provided with a second hidden portion 42 for accommodating and restricting the movement of the cutter head 50. Its distal end is open so as to communicate with the cutting groove 43, and its proximal end is closed to form a physical barrier. The height of the second hidden portion 42 is also greater than the height of the cutter head 50, and the length of the second hidden portion 42 is not less than the length of the cutter head 50, so that the cutter head 50 can be completely inserted into the second hidden portion 42 without obstruction when it retracts to the proximal end.

[0074] By setting the first hidden part 13 and the second hidden part 42, the blade head 50 can be prevented from being exposed when not in operation, thus avoiding accidental damage to surrounding tissues. When the blade head 50 is completely hidden in the first hidden part 13 or the second hidden part 42, the clamping arm 30 can open and close freely without being disturbed by the blade head 50, so as to accurately capture the mitral valve leaflets.

[0075] like Figure 9 In some embodiments, the moving part 40 is provided with a cutting groove 43 in the middle, and the side of the cutting groove 43 is open. When the cutting head 50 moves back and forth along the axial direction of the main body 20, the cutting edge of the cutting head 50 can be fully exposed and contact the leaflet tissue through this open cutting groove 43, so as to achieve precise cutting.

[0076] Specifically, the size and position of the cutting groove 43 correspond to the position of the mitral valve leaflet fixed after the clamp arm 30 is closed, ensuring that the cutting operation only occurs within the expected target area, avoiding accidental damage to surrounding healthy tissues, thereby improving the safety and accuracy of the surgery.

[0077] In some embodiments, the open area of ​​the cutting groove 43 is configured to fully expose the blade guide groove 222. On the one hand, the fully exposed blade guide groove 222 ensures that the blade 50 can achieve maximum cutting efficiency during the cutting process, without being affected by partial obstruction, allowing the blades on both sides of the blade 50 to fully contact the leaflet tissue for efficient cutting. On the other hand, the larger open area of ​​the guide groove provides greater spatial freedom for the clamping arm 30, allowing for the configuration of clamping arms 30 of various sizes or larger sizes. This enables the device to accommodate and fix leaflet tissue of various sizes and thicknesses, enhancing the adaptability and versatility of the device. Especially for patients with thickened or degenerated leaflets, the larger clamping arm 30 design ensures full capture and stabilization of the leaflets, providing a stable foundation for subsequent cutting operations.

[0078] like Figure 6 , Figure 10In some embodiments, the guide portion 22 passes through the movable member 40. An axially extending limiting slider 221 is provided on the outer periphery of the guide portion 22. The cross-section of the limiting slider 221 can be configured as rectangular, trapezoidal, or other combined shapes. A limiting groove 41 is provided on the inner side of the movable member 40. The limiting groove 41 and the limiting slider 221 match each other, forming an axially movable but circumferentially fixed constraint relationship between the movable member 40 and the main body 20. When the doctor pushes and pulls the movable member 40 during operation, the movable member 40 can move smoothly back and forth along the guide portion 22, while the limiting slider 221 slides within the limiting groove 41, preventing any circumferential rotation of the movable member 40 relative to the main body 20. This avoids the clamping arm 30 from shifting position during surgery due to rotation, causing a shift in the clamping point of the mitral valve leaflets, and maintaining the stability of the device.

[0079] Furthermore, this limiting design ensures precise alignment between the cutting groove 43 and the cutter head 50, guaranteeing the accuracy of the cutting operation. During repeated operations, regardless of how the moving part 40 moves back and forth, the limiting slider 221 and the limiting groove 41 ensure that the cutting groove 43 always maintains the correct relative position with the cutter head 50, allowing the cutter head 50 to accurately contact the target area of ​​the mitral valve leaflet through the cutting groove 43.

[0080] like Figure 11 , Figure 12 In some embodiments, the distal end of the movable member 40 is provided with a pivot point 32, and the boss of the clamping arm 30 is located further away from the pivot point 32. When the clamping arm 30 is closed, the boss approaches but does not exceed the top of the guide groove 11, ensuring that the boss does not exceed the range of the guide groove 11 and avoiding accidental collision between the boss and other parts of the distal control member 10. When the movable member 40 moves axially, the clamping arm 30 will rotate around the pivot point 32 through the rotational transmission of the pivot point 32. The guide groove 11 acts as a motion constraint, controlling the movement trajectory of the boss, thereby precisely controlling the opening and closing angle and speed of the clamping arm 30.

[0081] Taking into account the anatomical differences among patients, the rotation angle of the clamp arm 30 when it is opened is configured to accommodate leaflet tissue of various thicknesses, including those that are thickened due to pathological changes; the ample opening space ensures that the mitral valve leaflets can be fully inserted into the clamping area, avoiding incomplete cutting or tissue slippage that may result from partial clamping.

[0082] When the clamp arm 30 is open, the angle between the clamp arm 30 and the moving part 40 needs to allow the mitral valve leaflet to fully enter. When the clamp arm 30 is closed, the outer surface of the clamp arm 30, the outer contour of the cutting groove 43, and the outer contour of the distal control part 10 are all located on the same cylindrical surface to reduce friction and irritation to the blood vessel wall when the device moves in the blood vessel, thereby reducing endothelial damage and the risk of thrombosis.

[0083] In some embodiments, the axial projection of the guide groove 11 has a preset angle with the axis of the remote control member 10, and the preset angle is positively correlated with the opening rate of the clamping arm 30; the length of the guide groove 11, and / or the preset angle, is positively correlated with the opening angle of the clamping arm 30.

[0084] Specifically, a longer guide groove 11 or a larger preset angle allows the clamping arm 30 to reach a larger opening angle to accommodate thicker mitral valve leaflets; while a shorter guide groove 11 or a smaller preset angle provides finer control and more precise positioning.

[0085] Furthermore, the larger the preset angle of the guide groove 11, the faster the clamping arm 30 opens for the same axial movement distance; conversely, the smaller the preset angle, the slower the clamping arm 30 opens. By adjusting the preset angle of the guide groove 11, the opening and closing speed of the clamping arm 30 can be controlled, avoiding sudden impact on fragile tissues. Those skilled in the art can adjust the value of the preset angle of the guide groove 11 according to actual clinical needs to find the optimal balance between sensitive response and stable control. In this embodiment, the specific size of the preset angle is not limited.

[0086] like Figure 1 , Figure 2 , Figure 9 , Figure 11 During mitral valve resection, the hemodynamic forces generated by the continuous heartbeat constantly attempt to pull the mitral valve leaflets out of the cutting device. Traditional smooth clamping surfaces may be unable to resist this continuous pulling force, leading to tissue slippage and surgical failure. Therefore, in some embodiments, barbed structures 60 are provided on both sides of the proximal end of the clamping arm 30, and barbed structures 60 are also provided on both sides of the cutting groove 43. When the clamping arm 30 is closed, the barbed structures 60 cooperate with each other to stably clamp and fix the mitral valve leaflets, preventing the mitral valve leaflets from slipping under the impact of heartbeat and blood flow.

[0087] In some embodiments, the barb structure 60 may be evenly or unevenly distributed along both sides of the clamp arm 30.

[0088] When the barbs are evenly distributed, the clamping force can be evenly distributed on the leaflet contact surface, avoiding tissue necrosis or damage that may be caused by excessive local pressure, while providing sufficient overall clamping force. This evenly distributed design is suitable for most cases and can provide a stable and reliable clamping effect while ensuring tissue integrity.

[0089] When the barbs 60 are unevenly distributed, they can be adaptively customized for different lesion types to improve the device's applicability in complex cases. For example, in rheumatic mitral valve disease, the leaflet edges are often thickened, while the center may be relatively thin. In this case, longer or sharper barbs can be designed on the clamping arms 30 at the corresponding edges, while a gentler barb configuration is used in the central region, achieving differentiated clamping for different areas.

[0090] In this embodiment, the size, shape and distribution of the barb structure 60 are no longer specifically limited. Those skilled in the art can make adaptive selections or adjustments based on the patient's actual physiological and pathological condition.

[0091] The normal function of the mitral valve depends not only on the integrity of the leaflets themselves, but also on the coordinated work of the entire papillary muscle-chordae tendineae-leaflet complex. Therefore, in some embodiments, the proximal end of the clamping arm 30 is provided with a convex head 33, which has a smooth arc or wedge-shaped structure that gradually narrows proximally, forming a streamlined transition structure. When the clamping arm 30 closes, the chordae tendineae slide naturally to both sides along the surface of the convex head 33 and are guided to the side of the clamping arm 30, rather than being directly clamped or cut. This effectively avoids the chordae tendineae falling into the main clamping area and potentially causing entanglement or damage, helping to maintain the valve's natural movement pattern postoperatively, reducing blood flow disturbances or abnormal stress distribution that may be caused by anatomical changes, thereby reducing the risk of long-term complications.

[0092] like Figure 11 , Figure 12 In some embodiments, the proximal sides of the clamping arm 30 are also provided with arc-shaped grooves 34. The arc of the grooves 34 extends along the axial direction of the clamping arm 30. The grooves 34 are used to increase the volume of the mitral valve leaflets that can be clamped, creating a receiving space that is morphologically matched to the mitral valve leaflets. When the clamping arm 30 is closed, the mitral valve leaflet tissue can naturally fill the grooves 34, achieving complete and uniform clamping, and avoiding the risk of tissue overflowing from the edge of the clamping arm 30 or being excessively compressed.

[0093] In certain special cases, such as when there are local vegetations or irregular thickening of the mitral valve leaflets, these pathological changes may form irregular protrusions or lumps, which are difficult to hold stably with conventional clamping arms 30. However, clamping arms 30 with grooves 34 can better adapt to these irregular shapes and provide a more reliable fixation effect.

[0094] Furthermore, traditional planar clamping surfaces may cause pressure concentration at the leaflet edge, leading to local tissue damage. However, the arc-shaped groove 34 can optimize the distribution of clamping force on the leaflet tissue, making the clamping force more evenly distributed over a larger contact area, reducing the pressure per unit area, reducing the risk of tissue necrosis or penetration, while maintaining sufficient overall clamping stability.

[0095] In this embodiment, after the distal end of the mitral valve leaflet cutting device reaches the mitral valve, the inner sheath remains stationary while the middle sheath moves proximally. This controls the opening and closing of the clamping arm 30 to clamp and fix the mitral valve leaflet. Then, the axial reciprocating control lever 53 moves the blade 50 from proximal to distal to cut the mitral valve leaflet, or from distal to proximal. After cutting the leaflet, the mitral valve leaflet cutting device is withdrawn from the body along the original vascular pathway to facilitate subsequent surgical procedures.

[0096] Example 2

[0097] This embodiment provides a mitral valve leaflet cutting system, including the mitral valve leaflet cutting device as described in Embodiment 1, and at least including an outer sheath; the various technical features already included in Embodiment 1 are naturally inherited in this embodiment and will not be repeated.

[0098] In some embodiments, the lumen of the outer sheath is used to insert the middle sheath, and the proximal end of the outer sheath can be inserted into a bending control handle. The bending control handle is used to adjust the bending angle of the outer sheath to improve the system's navigation capability in complex vascular pathways. Specifically, the structure of the bending control handle and the outer sheath can be selected from the structures disclosed in any of the prior art embodiments, and is not specifically limited here.

[0099] In this embodiment, when the mitral valve leaflet cutting system is in use, the outer sheath and the mitral valve leaflet cutting device are brought together with the guide wire to the target position in the patient's heart. The outer sheath allows the mitral valve leaflet cutting device to pass through the curved blood vessels more easily. After the mitral valve leaflet cutting device reaches the target position, the subsequent leaflet clamping and cutting operations are carried out. The specific method is the same as in the above embodiment 1, and will not be repeated here.

[0100] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of the present invention.

Claims

1. A mitral valve leaflet cutting device, characterized in that, include: - A remote control component, wherein the remote control component is provided with a guide groove extending obliquely along the axial direction; - Main body component, the distal end of which is fixedly connected to the distal control component; - Clamping arm, the distal end of which is provided with a limiting boss, the limiting boss being slidably fitted in the guide groove, the proximal end of which is used to clamp and fix the mitral valve leaflets; - A movable component, which is axially slidably sleeved on the outer periphery of the main body, with its distal end pivotally connected to the clamping arm. The axial movement of the movable component is used to drive the limiting boss to move along the guide groove, so that the clamping arm can rotate around its pivot point with the main body to achieve opening and closing. - A cutting head is axially movable within the main body. The cutting head can reciprocate along the axial direction of the main body when the clamping arm fixes the mitral valve leaflets, so as to cut the mitral valve leaflets.

2. The mitral valve leaflet cutting device according to claim 1, characterized in that, The axial projection of the guide groove has a preset angle with the axis of the remote control component, and the preset angle is positively correlated with the opening rate of the clamping arm. The length of the guide groove and / or the preset angle are positively correlated with the opening angle of the clamping arm.

3. The mitral valve leaflet cutting device according to claim 1, characterized in that, The proximal end of the remote control is provided with a first hidden portion for accommodating and restricting the movement of the cutter head. The proximal end of the first hidden portion is open, and the distal end of the first hidden portion is closed. The height of the first hidden portion is greater than the height of the cutter head.

4. The mitral valve leaflet cutting device according to claim 1, characterized in that, The remote control component has a first fixing part at its internal remote end, and the main body component has a second fixing part at its remote end. The outlines of the first fixing part and the second fixing part match, and the two are fixedly connected.

5. The mitral valve leaflet cutting device according to claim 4, characterized in that, The main body also includes an axially extending guide portion, which passes through the moving part; The guide part has an axially extending limiting slider on its outer periphery, and the moving part has a limiting groove on its inner side. The limiting groove and the limiting slider match each other to limit the circumferential rotation of the moving part.

6. The mitral valve leaflet cutting device according to claim 5, characterized in that, The guide section is provided with an axially extending cutter guide groove for accommodating the axial movement of the cutter head.

7. The mitral valve leaflet cutting device according to claim 1, characterized in that, The blade head has two blades extending obliquely to the distal end. The two blades include an outer blade and an inner blade. The cutting edge of the outer blade faces the proximal end, and the cutting edge of the inner blade faces the distal end.

8. The mitral valve leaflet cutting device according to claim 7, characterized in that, The proximal end of the cutter head is fixedly connected to a control rod, which is used to control the axial movement of the cutter head.

9. The mitral valve leaflet cutting device according to claim 5, characterized in that, The proximal end of the moving part is provided with a second hidden part for accommodating and restricting the movement of the cutter head. The distal end of the second hidden part is open, and the proximal end of the second hidden part is closed. The height of the second hidden part is greater than the height of the cutter head, and the length of the second hidden part is not less than the length of the cutter head.

10. The mitral valve leaflet cutting device according to claim 5, characterized in that, The moving part has a cutting groove in the middle, and the side of the cutting groove is open and can expose the cutting head, so that when the cutting head moves in the cutting groove, it can perform a cutting operation on the mitral valve leaflets.

11. The mitral valve leaflet cutting device according to claim 10, characterized in that, The cutting groove is provided with barbed structures on both sides, and the clamping arm is also provided with barbed structures on both sides of the proximal end. The barbed structures are used to clamp and fix the mitral valve leaflets.

12. The mitral valve leaflet cutting device according to claim 10, characterized in that, The outer contour of the clamping arm is configured such that when the clamping arm is in a closed state, the outer surface of the clamping arm, the outer contour of the cutting groove, and the outer contour of the remote control component are all located on the same cylindrical surface.

13. The mitral valve leaflet cutting device according to claim 1, characterized in that, The proximal end of the clamping arm is provided with a convex head, which gradually narrows along the proximal direction. The convex head can guide the chordae tendineae to slide to both sides when clamping the mitral valve leaflets, so as to avoid damage to the chordae tendineae and at the same time preserve the original shape of the mitral valve.

14. The mitral valve leaflet cutting device according to claim 1, characterized in that, The clamping arm is also provided with arc-shaped grooves on both sides. The arc of the grooves extends along the axial direction of the clamping arm. The grooves are used to increase the volume of the mitral valve leaflets that can be clamped.

15. The mitral valve leaflet cutting device according to any one of claims 1-14, characterized in that, It also includes the catheter section and the handle section; The catheter section is provided with a middle sheath and an inner sheath. The middle sheath is sleeved outside the inner sheath, and the two can move axially relative to each other. The distal end of the middle sheath is fixedly connected to the proximal end of the moving part, and the distal end of the inner sheath is fixedly connected to the proximal end of the main body. The handle is connected to the proximal end of the catheter and is used to control the axial movement of the middle sheath, the inner sheath, and the axial movement of the blade.

16. A mitral valve leaflet cutting system, characterized in that, The device includes the mitral valve leaflet cutting apparatus as described in any one of claims 1-15, wherein the mitral valve leaflet cutting system further includes at least an outer sheath.

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