Valve leaflet cutting device and system

Abstract

The invention relates to a valve leaflet cutting device and system. The valve leaflet cutting device comprises a far-end cutting part, and the far-end cutting part comprises a main body piece, a tool bit, a clamping arm and a moving piece; the tool bit is arranged in the main body piece, and a conductor material is arranged in at least part of the area of the tool bit and used for electrically cutting the leaflet tissue when the tool bit is powered on; the near end of the clamping arm is rotatably connected with the main body piece, and the far end is used for clamping and fixing a valve leaflet; the moving part is in sliding connection with the clamping arm, can axially move relative to the main body part and is used for driving the clamping arm to rotate around the main body part to realize opening and closing of the clamping arm; and when the clamping arms are closed and the valve leaflet is fixed, the knife head realizes electric cutting on the fixed valve leaflet after being electrified.

Description

Technical Field

[0001] The present invention relates to the field of medical instruments for cardiac surgery, and in particular to a valve leaflet cutting device and system. Background Art

[0002] Aortic stenosis is a common cardiovascular disease with a high mortality rate. In recent years, the development of transcatheter aortic valve replacement (TAVR) technology has brought innovation to the treatment of aortic stenosis. However, in surgeries such as TAVR, ViV-TAVR (valve-in-valve TAVR) and Redo-TAVR (repeat TAVR), the risk of coronary artery obstruction is a key problem, which limits the application of these technologies in more elderly patients with aortic valve disease.

[0003] The BASILICA technology was proposed to reduce the risk of coronary artery obstruction. This technology uses an electric guide wire to cut and tear the degenerated and thickened autologous valve leaflets or the failed biological valve leaflets, forming a triangular window before implanting the interventional valve, increasing the channel for blood flow to the aortic sinus to improve coronary artery hemodynamics.

[0004] Studies have shown that the BASILICA technique has a high success rate and can effectively reduce the incidence of coronary artery obstruction. However, although the BASILICA technique has shown potential in preventing coronary artery obstruction, it still has some shortcomings, especially in the existing technology, there is a lack of devices specifically designed for leaflet cutting, which limits the further development and application of related technologies. Summary of the invention

[0005] The invention discloses a leaflet cutting device and a system, aiming to solve the technical problems existing in the prior art.

[0006] The present invention adopts the following technical solutions:

[0007] In one aspect, the present invention provides a leaflet cutting device, comprising a distal cutting portion, wherein the distal cutting portion comprises:

[0008] -Main body;

[0009] - a cutting head, which is arranged inside the main body, and at least a part of the cutting head is provided with a conductive material, so as to realize electrical cutting of the valve leaflet tissue when power is supplied;

[0010] - a clamping arm, whose proximal end is rotatably connected to the main body and whose distal end is used to clamp and fix the valve leaflet;

[0011] - a moving part, which is slidably connected to the clamp arm, and can move axially relative to the main part, and is used to drive the clamp arm to rotate around the main part to realize the opening and closing of the clamp arm;

[0012] When the clamp arms are closed and the valve leaflets are fixed, the cutter head performs electrical cutting of the fixed valve leaflets after being energized.

[0013] As a preferred technical solution, the cutter head includes a cutter head body arranged at the distal end and a control rod extending to the proximal end;

[0014] The blade body is provided with a blade extending radially outward, at least the blade comprises a conductor material, and is used to realize electrical cutting of the valve leaflet tissue when electricity is supplied;

[0015] The control rod includes a conductive material and is electrically connected to the cutter head body.

[0016] As a preferred technical solution, the cutter head body further comprises an assembly portion, which is configured as a solid column or a hollow cylinder and is used for being detachably fixedly connected to the distal end of the control rod;

[0017] The blade is radially arranged outside the mounting portion, and the mounting portion is provided with a conductive material at least in a connection area with the blade.

[0018] As a preferred technical solution, the blade has a preset protruding height relative to the outer surface of the assembly portion, the bottom of the blade is provided with a first preset thickness, the top of the blade is provided with a second preset thickness, and the second preset thickness is not greater than the first preset thickness.

[0019] As a preferred technical solution, the cross section of the blade is configured as a triangle, a trapezoid or a rectangle.

[0020] As a preferred technical solution, the main body includes:

[0021] - The main body part is provided with a cutter head guide groove and a hollow inner cavity which are isolated from each other; at least a part of the outer side of the cutter head guide groove is open, and the control rod can control the cutter head body to move axially in the cutter head guide groove and be exposed, so as to realize electrical cutting and / or physical cutting of the leaflet tissue; the hollow inner cavity is provided with a distal opening and a proximal opening for passing a guide wire;

[0022] - a guide portion connected to the distal opening and communicating with the hollow inner cavity.

[0023] As a preferred technical solution, the main body portion includes a rigid material; the guide portion includes a soft material; and both the main body portion and the guide portion include an electrically insulating material.

[0024] As a preferred technical solution, the clamp arm is connected to the main body by a pivot connection structure to form a rotatable hinge point; a first boss is provided on the proximal side of the hinge point, and the first boss is slidably connected to the moving part; the axial movement of the moving part drives the clamp arm to rotate around the hinge point to achieve opening and closing, and when the clamp arm is in a closed state, the outer surface of the clamp arm and the outer contour of the cutter head guide groove are located on the same cylindrical surface.

[0025] As a preferred technical solution, a barb structure is provided on the inner side of the clamp arm, and the barb structure is used to fix the valve leaflet; a developing ring is provided on the outer side of the clamp arm.

[0026] As a preferred technical solution, the moving member is sleeved on the proximal outer side of the main member in a cylindrical shape and can move axially along the main member;

[0027] The outer peripheral surface of the moving part is provided with a notch, which matches the first boss so that the first boss can slide smoothly therein; the notch is inclined, and the length of the notch matches the maximum opening and closing angle of the clamping arm.

[0028] As a preferred technical solution, it also includes a proximal operating part and a catheter part, the proximal end of the catheter part is connected to the proximal operating part, and the distal end of the catheter part is connected to the distal cutting part;

[0029] The catheter part includes an inner sheath tube, a middle sheath tube and an outer sheath tube from the inside to the outside; the distal end of the inner sheath tube is connected to the main body, the distal end of the middle sheath tube is connected to the moving part, and the distal end of the outer sheath tube is used for bending control;

[0030] The proximal operating part includes a bending control handle and a cutting control handle; the bending control handle is connected to the outer sheath and is used to adjust the bending angle of the distal end of the outer sheath; the cutting control handle is used to control the opening and closing of the clamp arm and provide power to the cutter head.

[0031] As a preferred technical solution, a traction wire is inserted into the outer sheath tube, and the distal end of the traction wire is fixed to the distal end of the outer sheath tube;

[0032] The bending control handle comprises a first handle shell and a bending control adjustment mechanism arranged in the first handle shell, and the bending control adjustment mechanism comprises a threaded moving part, a rotating operating part and a traction wire fixing part;

[0033] The proximal end of the traction wire passes through the threaded moving part and is fixed on the traction wire fixing part. The distal end of the traction wire fixing part is fixedly connected to the proximal end of the threaded moving part. The threaded moving part and the rotating operating part are threadedly matched. The rotation of the rotating operating part is used to drive the axial movement of the threaded moving part, thereby pulling the traction wire to achieve the bending adjustment of the distal end of the outer sheath tube.

[0034] As a preferred technical solution, the proximal end of the bending control handle is also provided with a handle tailstock and a limit assembly, and the distal end of the cutting control handle is movably arranged on the handle tailstock;

[0035] The handle tail seat is fixedly connected to the proximal end of the first handle housing, and the handle tail seat is provided with a first limiting groove and a second limiting groove, the first limiting groove is arranged along the axial direction of the handle tail seat, and the second limiting groove is arranged at the proximal end of the handle tail seat and is arranged circumferentially;

[0036] The limiting assembly includes a positioning ring and a plurality of limiting rings;

[0037] Several limiting rings are arranged axially, and a second boss is provided on the inner side of the limiting ring, and a limiting groove is provided on the outer side; the second boss cooperates with the first limiting groove to limit the circumferential rotation of the limiting ring, and the limiting groove cooperates with the distal end locking of the cutting control handle to limit the axial movement and circumferential rotation of the cutting control handle relative to the bending control handle;

[0038] The positioning ring is arranged at the proximal end of the plurality of limiting rings, and a third boss is arranged on the inner side of the positioning ring. The third boss cooperates with the second limiting groove to limit the axial movement of the positioning ring.

[0039] As a preferred technical solution, the distal end of the cutting control handle is provided with a second handle housing and a middle sheath moving button assembly inside the housing;

[0040] The second handle housing is sleeved on the outer periphery of the limiting assembly and can move axially relative to the limiting assembly;

[0041] The mid-sheath moving button assembly includes:

[0042] The first movable button inner part has a fourth boss on its outer periphery that matches the limiting groove;

[0043] A first moving button outer member is sleeved on the outer side of the first moving button inner member;

[0044] The first elastic member is arranged between the first moving button inner member and the first moving button outer member, and is used to keep the fourth boss in locking cooperation with the limiting groove.

[0045] As a preferred technical solution, the cutting control handle also includes a middle sheath fixing member and a clamp arm opening and closing knob arranged at the proximal end of the second handle housing;

[0046] The middle part of the middle sheath fixing piece is through-through, and the proximal end of the middle sheath tube passes through the second handle housing and is fixedly connected to the middle sheath fixing piece; a fifth boss is also provided on the outer side of the middle sheath fixing piece;

[0047] The inner circumference of the clamp arm opening and closing knob is provided with an internal thread that cooperates with the cutting control handle thread, and is also provided with an annular groove that cooperates with the fifth boss, and the fifth boss can rotate circumferentially in the annular groove; the rotation of the clamp arm opening and closing knob is used to drive the axial movement of the middle sheath fixing part, thereby controlling the axial displacement of the moving part relative to the main body.

[0048] As a preferred technical solution, the cutting control handle also includes an inner sheath fixing part and a circuit control component;

[0049] The inner sheath is configured as a double-lumen tube, including a first lumen and a second lumen, the first lumen and the second lumen are separately arranged at the proximal end, the first lumen is used for passing the guide wire, and the second lumen is used for passing the control rod of the blade head;

[0050] The inner sheath fixing part is fixedly arranged in the cutting control handle, and the separated first cavity and the second cavity are both passed through the inner sheath fixing part and fixedly connected thereto;

[0051] The circuit control component is electrically connected to the control rod and is provided with an external connection port for electrically connecting to an external power supply device.

[0052] As a preferred technical solution, the proximal end of the cutting control handle is provided with a proximal external thread, and the proximal end of the cutting control handle also includes a third handle housing and a cutter head moving button assembly disposed therein;

[0053] The cutter head movement button assembly includes:

[0054] A cutter head fixing member fixedly connected to the proximal end of the control rod;

[0055] A second moving button inner part, the outer periphery of which is provided with an inner thread matching the proximal outer thread;

[0056] The second moving button outer part is sleeved on the outer side of the second moving button inner part;

[0057] A second elastic member is disposed between the second moving button inner member and the second moving button outer member;

[0058] Among them, when the second movable button outer part is pressed, the second elastic part is compressed to disengage the second movable button inner part from the proximal external thread, and the third handle shell can slide freely along the axial direction; when the movable button outer part is released, the second movable button inner part re-engages with the proximal external thread under the action of the second elastic part, and the axial displacement control of the control rod is realized by rotating the third handle shell.

[0059] On the other hand, the present invention also provides a leaflet cutting system, comprising the leaflet cutting device mentioned above.

[0060] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0061] The present invention mainly provides a leaflet cutting device and system, which adopts a combination of electrical cutting and physical cutting. By setting a conductor material on the blade of the blade body and its connection area, and forming a complete conductive path through a control rod, it can not only realize electrical cutting by powering on, but also realize precise physical cutting, thereby improving cutting efficiency and safety. In addition, the blade body and the control rod in the device are detachably connected, and blade configurations of different thicknesses are designed to meet different incision requirements.

[0062] Furthermore, the proximal end of the leaflet cutting device has a multi-level control mechanism, including bending control of the outer sheath, opening and closing control of the clamp arm, and displacement control of the blade head. Each control mechanism adopts at least a dual adjustment method of threaded fitting and quick unlocking, which not only ensures the accuracy of the adjustment, but also provides the convenience of quick adjustment, greatly improving the flexibility and accuracy of the surgical operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions explain the present invention and do not constitute improper limitations on the present invention. In the drawings:

[0064] Figure 1 This is a schematic structural diagram of a leaflet cutting device in an implementation manner disclosed in Example 1 of the present invention;

[0065] Figure 2 This is a schematic diagram of the distal cutting portion when the clamping arms are closed in an implementation manner disclosed in Example 1 of the present invention;

[0066] Figure 3 A schematic diagram of a distal cutting portion when the clamp arm is opened in an implementation manner disclosed in Example 1 of the present invention;

[0067] Figure 4 A cross-sectional view of a cutter head body at the far end of a cutter head guide groove in an implementation manner disclosed in Example 1 of the present invention;

[0068] Figure 5 A cross-sectional view of a cutter head body at the proximal end of a cutter head guide groove in an implementation manner disclosed in Example 1 of the present invention;

[0069] Figure 6 A schematic diagram of the structure of a cutter head in an implementation manner disclosed in Example 1 of the present invention;

[0070] Figure 7 This is a schematic structural diagram of a cutter head in another embodiment disclosed in Example 1 of the present invention;

[0071] Figure 8 A schematic diagram of the structure of double-sided blades in an implementation method disclosed in Example 1 of the present invention;

[0072] Fig. 9 This is a schematic diagram of the structure of a clamp arm in an implementation manner disclosed in Example 1 of the present invention;

[0073] Fig.10 A diagram showing the force state between the clamp arm and the moving part when the clamp arm is opened in an implementation method disclosed in Example 1 of the present invention;

[0074] Fig.11 A diagram showing the force state between the clamp arm and the moving part when the clamp arm is closed in an implementation manner disclosed in Example 1 of the present invention;

[0075] Fig.12 This is a schematic structural diagram of a bending control handle in an implementation method disclosed in Example 1 of the present invention;

[0076] Fig.13 A cross-sectional view of a bending control handle in an implementation manner disclosed in Example 1 of the present invention;

[0077] Fig.14 This is a schematic diagram of the structural coordination between the proximal end of the bending control handle and the distal end of the cutting control handle in an implementation manner disclosed in Example 1 of the present invention;

[0078] Fig.15 This is a schematic diagram of the structure of a handle tailstock in an implementation method disclosed in Example 1 of the present invention;

[0079] Fig.16 This is a schematic diagram of the structure of a limit ring in an implementation method disclosed in Example 1 of the present invention;

[0080] Fig.17 This is a schematic structural diagram of a positioning ring in an implementation method disclosed in Example 1 of the present invention;

[0081] Fig.18 This is a schematic structural diagram of a sheath moving button assembly in an implementation manner disclosed in Example 1 of the present invention;

[0082] Fig.19 This is a schematic diagram of the structure of the first moving button inner part in an implementation method disclosed in Example 1 of the present invention;

[0083] Fig. 20 This is a schematic diagram of the structure of a clamp arm opening and closing knob and a middle sheath fixing member in an implementation manner disclosed in Example 1 of the present invention;

[0084] Fig.21 This is a schematic structural diagram of a sheath fixing member in an implementation manner disclosed in Example 1 of the present invention;

[0085] Fig. 22 This is a schematic diagram of the structure of a clamp arm opening and closing knob in an implementation manner disclosed in Example 1 of the present invention;

[0086] Fig.23 A schematic diagram of the structure of a circuit control component in an implementation method disclosed in Example 1 of the present invention;

[0087] Fig.24 This is a structural schematic diagram of a cutter head moving button assembly in an implementation manner disclosed in Example 1 of the present invention;

[0088] Fig.25 This is a schematic diagram of the structure of the second moving button inner part in an implementation method disclosed in Example 1 of the present invention;

[0089] Fig.26 This is a schematic diagram of the operation of a leaflet cutting device in the heart in an implementation manner disclosed in Example 1 of the present invention;

[0090] Fig. 27 This is a schematic diagram of an external power supply device in an implementation manner disclosed in Example 1 of the present invention.

[0091] Description of reference numerals:

[0092] Distal cutting portion 10, guiding portion 11, main body portion 12, blade guide groove 121, blade hidden cavity 1211, moving member 13, notch 131, blade 14, blade 141, assembly portion 142, control rod 143, clamping arm 15, first boss 151, barb structure 152, catheter portion 20, outer sheath 21, middle sheath 22, inner sheath 23, bending control handle 30, threaded moving member 31, rotating operating member 32, traction wire fixing member 33, handle tail seat 34, first limiting groove 341, second limiting groove 342, limiting ring 35, second boss 351, limiting groove 352, positioning ring 3 6, third boss 361, second handle shell 41, first movable button inner part 42, fourth boss 421, first movable button outer part 43, first elastic part 44, middle sheath fixing part 45, fifth boss 451, clamp arm opening and closing knob 46, annular groove 461, inner sheath fixing part 51, circuit control component 52, external port 521, power switch 522, proximal external thread 61, third handle shell 62, blade fixing part 63, second movable button inner part 64, second movable button outer part 65, second elastic part 66, external power supply device 70, guide wire 80, aortic arch 91, aortic valve 92. DETAILED DESCRIPTION

[0093] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise.

[0094] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense. In addition, in the description of this application, the terms "first", "second" and the like are only used to distinguish the description and cannot be understood as indicating or implying relative importance. The "proximal end" mentioned in the text refers to the end close to the operator along the length direction of the leaflet cutting device, and the "distal end" refers to the end away from the operator along the length direction of the leaflet cutting device.

[0095] It is known to those skilled in the art that in order to achieve their respective functions and meet the requirements of surgical operations, the specific shapes / sizes / angles of the structures can be adaptively adjusted. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0096] Example 1

[0097] Based on the background technology, it can be seen that although the existing BASI LICA technology can be used to prevent coronary artery obstruction, its operation steps are complicated, the positioning accuracy of the device is insufficient, and there is a lack of effective safety protection measures during the leaflet cutting process. At the same time, the existing technology lacks a special leaflet clamping mechanism and an adjustable cutting device, which makes it difficult to adapt to the cutting needs of different surgical scenarios. These problems limit the promotion and application of this technology in the elderly aortic valve disease patient group.

[0098] In order to solve the problems existing in the prior art, an embodiment of the present invention provides a leaflet cutting device, which is preferably suitable for transcatheter aortic valvulectomy, and is particularly suitable for treating lesions such as aortic valve stenosis or calcification before implanting an artificial valve, so as to improve coronary hemodynamics and reduce the risk of coronary artery obstruction.

[0099] refer to Figure 1 — Fig.11The leaflet cutting device includes a distal cutting part 10, a catheter part 20 and a proximal operating part from the distal end to the proximal end, wherein the distal cutting part 10 includes a main body, a moving part 13, a cutter head 14 and a clamp arm 15, the proximal operating part includes a bending control handle 30 and a cutting control handle, and the catheter part 20 includes an outer sheath tube 21, a middle sheath tube 22 and an inner sheath tube 23 from the outside to the inside, the proximal end of the outer sheath tube 21 is connected to the bending control handle 30, the distal end of the outer sheath tube 21 can be adjusted to adapt to the structural direction of the blood vessel, and the proximal end of the middle sheath tube 22 is arranged on the cutting In the cutting control handle, the distal end of the middle sheath 22 is connected to the main body, and the proximal end of the inner sheath 23 is also inserted into the cutting control handle. The distal end of the middle sheath 22 is connected to the moving part 13. By controlling the cutting control handle, the relative movement of the middle sheath 22 and the inner sheath 23 can be achieved to control the opening and closing of the clamping arm 15 and clamp the leaflets, so that the blade head 14 can cut the leaflets; preferably, at least part of the area of ​​the blade head 14 is also provided with a conductive material, which can supply power to the blade head 14 when the cutting control handle is energized to achieve electrical cutting of the leaflet tissue.

[0100] like Figure 2 , Figure 3 In some embodiments, the main body includes a main body portion 12 and a guide portion 11 connected thereto.

[0101] In some embodiments, the main body portion 12 is configured as a dual-cavity structure, including a hollow inner cavity and a blade guide groove 121 that are isolated from each other, both of which extend axially along the main body portion 12, wherein the hollow inner cavity is provided with a distal opening and a proximal opening for passing a guide wire 80, and the side of the blade guide groove 121 is open to accommodate the blade 14 for axial movement therein, and during the movement, the blade 14 is exposed to the open area of ​​the blade guide groove 121 to achieve electrical cutting and / or physical cutting of the leaflet.

[0102] like Figure 4 , Figure 5In some embodiments, the blade guide groove 121 further includes a guide cavity and a blade hidden cavity 1211, wherein the guide cavity is arranged in the middle of the blade guide groove 121, and is a side open area of ​​the blade guide groove 121, and when the blade 14 moves therein, a physical cutting operation on the leaflet can be achieved; further, a blade hidden cavity 1211 is provided at both the proximal and distal ends of the blade guide groove 121, and at least the length of the blade hidden cavity 1211 at the distal end is not less than the length of the distal end of the blade 14. The length of the blade 141 and the height of the blade hidden cavity 1211 are greater than the height of the blade 141. During the transportation of the blade 14, the blade 141 is located in the blade hidden cavity 1211 at the distal end. When the blade 14 moves to the proximal end of the blade guide groove 121, the blade 141 is located in the blade hidden cavity 1211 arranged at the proximal end. By setting the blade 14 as a hidden structure, the risk of damaging tissue due to the exposure of the blade 141 during the transportation of the distal cutting part 10 can be effectively reduced.

[0103] In some embodiments, the guide portion 11 is roughly conical and fixedly connected to the distal opening of the hollow inner cavity, that is, the guide portion 11 is the farthest end of the entire leaflet cutting device; an axially through cavity is provided in the guide portion 11, and the cavity is connected to the hollow inner cavity of the main body portion 12, for passing a guide wire 80. Specifically, the guide wire 80 can play a positioning role during the operation. When the leaflet cutting is completed, the leaflet cutting device is withdrawn from the body along the guide wire 80, and then other instruments can be inserted to carry out subsequent surgical operations.

[0104] In some embodiments, the guide portion 11 is made of a soft material, while the main body portion 12 is made of a rigid material; the flexible guide portion 11 can, on the one hand, reduce the risk of stimulation and potential damage to the blood vessel wall, and on the other hand, can better adapt to the curvature and changes of the blood vessel and improve the passing performance of the device; and the rigid main body portion 12 can provide sufficient rigidity and strength for the entire distal cutting portion 10 to ensure the stability of the operation and the accuracy of clamping and cutting the leaflets.

[0105] In some embodiments, the guide portion 11 is injection molded from a soft material, and the main body portion 12 is injection molded from an insulating, high-hardness material. The insulating main body portion 12 can prevent current leakage from the blade 14 during electric cutting to protect the safety of the patient and the operator.

[0106] like Figure 6 — Figure 8 In some embodiments, the cutting head 14 includes a control rod 143 and a cutting head body disposed at its distal end. The proximal end of the control rod 143 extends to the proximal operating part and can be energized. On the one hand, the control rod 143 can be electrically connected to the cutting head body to achieve electrical cutting. On the other hand, it can control the axial movement of the cutting head body to achieve physical cutting of the leaflet tissue.

[0107] In some embodiments, the blade body is provided with a blade 141 extending radially outward, and the blade 141 can be configured as a single-sided blade, such as Figure 6 , Figure 7 , or double-sided blades, such as Figure 8 The blade 141 and the area connected to the control rod 143 are made of conductive material, which is used for pneumatic and electrical connection with the control rod 143. The control rod 143 is also made of conductive material. When power is not supplied, only the axial movement of the blade body in the blade guide groove 121 can be controlled to achieve physical cutting of the leaflets. When power is supplied, the blade 141 on one side or both sides made of conductive material can achieve electrical cutting of the leaflets, which is particularly suitable for calcified leaflets. Specifically, physical cutting or electrical cutting of the blade 14 can be selected as needed according to clinical use requirements.

[0108] In some embodiments, the outer surface of the control rod 143 is also provided with an insulating coating to prevent accidental electric shock when the blade body is performing electrical cutting.

[0109] In some embodiments, the blade body also includes an assembly portion 142, and the outer peripheral surface of the assembly portion 142 is provided with an installation area for installing the blade 141, and at least the installation area is provided with a conductive material to ensure a stable electrical connection between the blade 141 and the assembly portion 142; the assembly portion 142 and the blade 141 can be fixedly connected or integrally formed.

[0110] In some embodiments, the assembly portion 142 and the distal end of the control rod 143 are configured as a detachable fixed connection; the assembly portion 142 is configured as a solid column or a hollow cylinder. When configured as a hollow cylinder structure, its inner cavity diameter is adapted to the outer diameter of the control rod 143 to facilitate the assembly connection between the two.

[0111] In some embodiments, the proximal end of the assembly portion 142 can be reliably mechanically and electrically connected to the distal end of the control rod 143 by threaded connection, welding, riveting, etc. This detachable connection method facilitates the replacement of blade heads 14 of different specifications and shapes to meet the cutting requirements of different surgical scenarios. When a large incision operation is required, a thicker blade head 14 can be selected, such as Figure 7 , to provide sufficient cutting force, when a small incision is required, a thinner blade head 14 can be selected, such as Figure 6 , in order to reduce the impact on surrounding tissues.

[0112] In some embodiments, the blade 141 has a preset protruding height relative to the outer surface of the assembly portion 142, and the protruding height is pre-set according to actual cutting requirements, but should be smaller than the radius of the main body to achieve a hidden structure of the blade head 14 and ensure smooth movement of the blade head 14; the blade 141 adopts a gradient design, with a first preset thickness at the bottom, gradually thinning to a second preset thickness toward the top, wherein the second preset thickness is not greater than the first preset thickness, which ensures that the bottom of the blade 141 has sufficient connection strength and stability, and that the top of the blade 141 has good cutting sharpness.

[0113] To meet different cutting requirements, the cross section of the blade 141 can be selected in different geometric shapes: when a triangular cross section is selected, the best cutting sharpness can be obtained; when a trapezoidal cross section is adopted, both good cutting performance and better structural strength are maintained; and a rectangular cross section provides maximum structural stability while ensuring the cutting effect. The most suitable cross-sectional shape of the blade 141 can be selected according to the characteristics and requirements of the specific surgical site, and no specific limitation is given here.

[0114] In some embodiments, when the blade 141 is configured as a double-sided blade, the double-sided blade is tilted on the assembly portion 142, with the outer blades of the double-sided blades facing the distal end and the inner blades of the double-sided blades facing the proximal end. When the starting position of the blade head 14 is at the distal end of the blade head guide groove 121, after capturing the leaflet, the blade head 14 is pulled back toward the proximal end, and the inner blade can start cutting from the root of the leaflet; when the starting position of the blade head 14 is at the proximal end of the blade head guide groove 121, after capturing the leaflet, the blade head 14 is pushed toward the distal end, and the outer blade can start cutting from the apposing edge of the leaflet, thereby achieving partial cutting of the leaflet.

[0115] refer to Figure 2 , Figure 3 , Fig. 9 In some embodiments, the proximal end of the clamp arm 15 is rotatably connected to the main body, and the distal end thereof is used to clamp and fix the leaflet. The movable member 13 is cylindrically sleeved on the proximal end of the main body and is slidably connected to the clamp arm 15. The movable member 13 can move axially relative to the main body, and is used to drive the clamp arm 15 to rotate around the main body to achieve the opening and closing of the clamp arm 15. When the clamp arm 15 is closed and clamps the leaflet, the axial movement of the cutter head 14 is used to achieve physical cutting of the fixed leaflet.

[0116] In some embodiments, the clamp arm 15 is connected to the main body by a pivot connection structure such as rivets to form a rotatable hinge point, and a first boss 151 is provided on the proximal side of the hinge point, and the first boss 151 is slidably connected to the movable member 13; the outer peripheral surface of the movable member 13 is provided with an inclined notch 131, and the notch 131 matches the first boss 151, and the first boss 151 can slide smoothly along the notch 131; the axial movement of the movable member 13 can drive the clamp arm 15 to rotate around the hinge point to achieve opening and closing. When the clamp arm 15 is in a closed state, the outer surface of the clamp arm 15 and the outer contour of the hidden cavity are located on the same cylindrical surface, which minimizes the stimulation and damage to the blood vessel wall during intravascular delivery.

[0117] In some embodiments, the length of the slot 131 determines the maximum opening and closing angle of the clamp arm 15. By adjusting the length of the slot 131, specific opening and closing angles can be designed for leaflets of different sizes to improve adaptability; and the inclination angle of the slot 131 matches the opening and closing speed of the clamp arm 15. A larger inclination angle will result in a faster opening and closing speed, while a smaller angle will make the opening and closing slower and more controllable. By adjusting the inclination angle of the slot 131, the opening and closing speed of the clamp arm 15 can be controlled to avoid sudden impact on fragile tissues; in this embodiment, the length or inclination angle of the slot 131 is no longer specifically limited, and technicians in this field can make adjustments according to the actual needs of different patients.

[0118] In some embodiments, the position of the notch 131 also determines the opening and closing force of the clamp arm 15; Fig.10 When the leaflet cutting device is opened, the first boss 151 of the clamp arm 15 is subjected to the horizontal pulling force FA of the moving part 13, and FA is decomposed into the force FA1 along the notch 131 and the force FA2 perpendicular to the notch 131. L1 is the distance from the point of force application to the rotation axis. According to the moment formula M=F*L, the force arm is long, the clamp arm 15 is subjected to less force, and it is easier to open and close; refer to Fig.11 When the leaflet cutting device is closed, the first boss 151 of the clamp arm 15 is subjected to the horizontal thrust FB of the moving part 13, and FB is decomposed into a force FB1 along the direction of the notch 131 and a force FB2 perpendicular to the notch 131. L2 is the distance from the point of force application to the rotation axis. According to the moment formula M=F*L, the force arm is short, and the clamp arm 15 exerts a greater force on the main part at this time, and the clamping force is better. In this embodiment, the specific position of the notch 131 is no longer limited, and those skilled in the art can adjust it according to the actual needs of different patients.

[0119] In some embodiments, a developing ring is provided on the outer side of the clamp arm 15 for observing the position of the leaflet cutting device under surgical angiography to facilitate the operator to make corresponding adjustments.

[0120] like Fig. 9In some embodiments, the inner side of the clamp arm 15 is provided with a barb structure 152. When the clamp arm 15 is closed, the leaflet is located between the clamp arm 15 and the main body. The barb structure 152 can fix the position of the leaflet to prevent the leaflet from sliding or shifting during the cutting process, so as to facilitate the subsequent cutting operation. Optionally, the barb structure 152 includes but is not limited to a tooth shape, a cone shape, and a rake shape, and the barb structures 152 on both sides of the clamp arm 15 can be configured in different shapes and / or quantities, so as to make the leaflet fit the clamp arm 15 and the main body more closely.

[0121] Specifically, barb structures 152 of different shapes / sizes can adapt to leaflet tissues of different thicknesses, hardnesses, and textures. For example, a toothed structure may be more suitable for thin leaflets, while a stronger conical or rake-shaped structure may be required for thicker or calcified leaflets. By distributing the barbs in different quantities, the pressure distribution can be optimized to avoid excessive local pressure causing tissue tearing and other damage. By selecting the appropriate barb shape, size, and quantity, it is possible to minimize damage to the leaflet tissue while providing sufficient fixing force, which is not specifically limited in this embodiment.

[0122] In some embodiments, the clamp arm 15 and the moving member 13 are both made of insulating materials to prevent accidental electric shock when the cutter head 14 performs electric cutting, while reducing thermal damage to surrounding areas caused by heat generated during the electric cutting process.

[0123] In some embodiments, when the clamp arm 15 is closed, the front view of the entire distal cutting portion 10 is circular, and the maximum diameter does not exceed 6 mm, so as to facilitate delivery in the artery; further, the outer surface of the entire distal cutting portion 10 is a roughly continuous cylinder without other protruding structures, so as to avoid damage to blood vessels or other tissues during delivery.

[0124] In some embodiments, at least one axially extending traction wire is passed through the outer sheath 21, the distal end of the traction wire is fixed to the distal end of the outer sheath 21, and the proximal end of the traction wire extends out of the proximal end of the outer sheath 21. When the proximal end of the traction wire is pulled, the distal end of the outer sheath 21 can be bent, so that the leaflet cutting device can more conveniently pass through large curved blood vessels such as the aortic arch 91 through the femoral artery approach, thereby improving the navigation ability of the device in complex vascular pathways.

[0125] like Fig.12 , Fig.13In some embodiments, the bending control handle 30 includes a first handle shell and a bending control adjustment mechanism disposed in the first handle shell, the bending control adjustment mechanism includes a threaded moving member 31, a rotating operating member 32 and a traction wire fixing member 33; the proximal end of the traction wire passes through the threaded moving member 31 and is fixed to the traction wire fixing member 33, and the distal end of the traction wire fixing member 33 is fixedly connected to the proximal end of the threaded moving member 31, forming a linkage mechanism; a knob is fixedly connected to the outer side of the rotating operating member 32 for easy rotation operation. During operation, when the doctor rotates the rotating operating member 32 through the knob, due to the threaded matching relationship between the threaded moving member 31 and the rotating operating member 32, the threaded moving member 31 will produce axial displacement, and this axial displacement is transmitted to the traction wire through the traction wire fixing member 33, thereby achieving accurate pulling of the distal end of the traction wire. By controlling the rotation direction and angle of the rotating operating member 32, the bending direction and degree of the distal end of the outer sheath tube 21 can be accurately adjusted, so as to facilitate accurate navigation of the device to the target surgical position.

[0126] like Fig.14 — Fig.19 In some embodiments, the proximal end of the bending control handle 30 is movably connected to the distal end of the cutting control handle, and the cutting device control handle is designed as a whole. By adjusting it, the leaflet cutting device as a whole (excluding the sheath 21 and the bending control handle 30) can be moved forward and backward and rotated left and right to adjust the posture and position of the distal cutting part 10.

[0127] like Fig.15 — Fig.17 In some embodiments, a handle tail seat 34 and a limiting assembly are provided at the proximal end of the bending control handle 30, and the distal end of the cutting control handle is movably arranged on the handle tail seat 34; the handle tail seat 34 is fixedly connected to the proximal end of the first handle shell, and the handle tail seat 34 is provided with a first limiting groove 341 and a second limiting groove 342, the first limiting groove 341 is arranged along the axial direction of the handle tail seat 34, and the second limiting groove 342 is arranged at the proximal end of the handle tail seat 34 and is arranged circumferentially; the limiting assembly includes a positioning ring 36 and a plurality of limiting rings 35, and the plurality of limiting rings 35 are arranged axially, and the limiting rings 35 are arranged axially. A second boss 351 is provided on the inner side, and a limiting groove 352 is provided on the outer side; the second boss 351 cooperates with the first limiting groove 341 to limit the circumferential rotation of the limiting ring 35, and the limiting groove 352 cooperates with the distal end lock of the cutting control handle to limit the axial movement and circumferential rotation of the cutting control handle relative to the bending control handle 30; the positioning ring 36 is arranged at the proximal end of several limiting rings 35, and a third boss 361 is provided on the inner side thereof, and the third boss 361 cooperates with the second limiting groove 342 to limit the axial movement of the positioning ring 36 to ensure the axial stability of the entire limiting assembly.

[0128] like Fig.18 , Fig.19In some embodiments, in cooperation with the limiting assembly, the distal end of the cutting control handle is also provided with a second handle shell 41 and an inner sheath moving button assembly therein; the second handle shell 41 is sleeved on the outer periphery of the limiting assembly and can move axially relative to it; the inner sheath moving button assembly includes a first moving button inner part 42, a first moving button outer part 43 and a first elastic part 44, wherein the outer periphery of the first moving button inner part 42 is provided with a fourth boss 421 that cooperates with the limiting groove 352, the first moving button outer part 43 is sleeved on the outside of the first moving button inner part 42, and the first elastic part 44 is arranged between the first moving button inner part 42 and the first moving button outer part 43, for keeping the fourth boss 421 in a locking fit with the limiting groove 352.

[0129] When the circumferential angle or axial position of the leaflet cutting device needs to be adjusted, the first movable button outer member 43 can be pressed to compress the first elastic member 44, so that the fourth boss 421 temporarily disengages from the limiting groove 352, thereby realizing the axial movement or circumferential rotation of the cutting control handle; when the adjustment is in place, the first movable button outer member 43 is released, and under the action of the first elastic member 44, the fourth boss 421 will re-engage with the limiting groove 352 to lock the new position. The cooperation between the limiting assembly and the cutting control handle ensures both the flexibility of operation and the stability of positioning, thereby improving the accuracy and safety of the operation.

[0130] In some embodiments, the proximal end of the middle sheath moving button assembly is also provided with a clamp arm opening and closing knob 46, a circuit control assembly 52 and a blade head 14 moving assembly in sequence.

[0131] like Fig. 20 — Fig. 22 In some embodiments, a middle sheath fixing member 45 is provided on the inner side of the clamp arm opening and closing knob 46, the middle part of the middle sheath fixing member 45 is through, and the proximal end of the middle sheath tube 22 passes through the second handle housing 41 and is fixedly connected to the middle sheath fixing member 45; a fifth boss 451 is also provided on the outer side of the middle sheath fixing member 45; the inner periphery of the clamp arm opening and closing knob 46 is provided with an internal thread that matches with the thread of the cutting control handle, and is also provided with an annular groove 461 that matches with the fifth boss 451, and the fifth boss 451 can rotate circumferentially in the annular groove 461; When the clamp arm opening and closing knob 46 is rotated, due to the effect of the threaded cooperation, the clamp arm opening and closing knob 46 can rotate and move axially on the cutting control handle, and the annular groove 461 cooperates with the fifth boss 451 to drive the middle sheath fixing part 45 to synchronously produce axial displacement. The middle sheath fixing part 45 is fixedly connected to the middle sheath tube 22, and finally realizes precise control of the distal moving part 13, thereby adjusting the opening and closing angle of the clamp arm 15, and at the same time avoids the unexpected opening and closing of the clamp arm 15 during use.

[0132] like Fig.23In some embodiments, an inner sheath fixing part 51 is further provided inside the circuit control component 52 for connecting with the proximal end of the inner sheath tube 23; the inner sheath tube 23 is configured as a double-lumen tube, including a first lumen and a second lumen, the first lumen and the second lumen are separated at the proximal end, the first lumen is used to pass the guide wire 80, and its inner diameter matches the specifications of the commonly used guide wires in clinical practice to ensure that the guide wire can pass smoothly; the second lumen is used to pass the control rod 143, and an insulating layer can be provided on its inner wall to prevent current leakage; the inner sheath fixing part 51 is fixedly arranged in the cutting control handle, and the separated first lumen and the second lumen are both passed through the inner sheath fixing part 51 and fixedly connected thereto; the circuit control component 52 is electrically connected to the control rod 143 through a wire, and the circuit control component 52 is also provided with an external port 521 and a power switch 522 for electrically connecting to an external power supply device 70. When the power switch 522 is pressed, the blade 14 is powered on to implement electrocuting; the host of the external power supply device 70 can select an existing electrocuting control host on the market, such as Fig. 27 The model is not limited here. The external port 521 of the leaflet cutting device is configured according to universal specifications and standards, and can be used by plugging in an external power supply device 70.

[0133] like Fig.24 , Fig.25 In some embodiments, the cutter head moving button assembly is encapsulated in the third handle shell 62, and the proximal end of the cutting control handle is provided with a proximal external thread 61 that is compatible with the cutter head moving button assembly; the cutter head moving button assembly includes a cutter head fixing part 63, a second moving button inner part 64, a second moving button outer part 65 and a second elastic part 66, wherein the cutter head fixing part 63 is fixedly connected to the proximal end of the control rod 143, the outer periphery of the second moving button inner part 64 is provided with an internal thread that matches the proximal external thread 61, the second moving button outer part 65 is sleeved on the outside of the second moving button inner part 64, and the second elastic part 66 is arranged between the second moving button inner part 64 and the second moving button outer part 65. When the second movable button outer part 65 is pressed, the second elastic part 66 is compressed to disengage the second movable button inner part 64 from the proximal external thread 61, and the third handle shell can slide freely in the axial direction; when the movable button outer part is released, the second movable button inner part 64 is re-engaged with the proximal external thread 61 under the action of the second elastic part 66, and the blade fixing part 63 is driven to move axially by rotating the third handle shell, thereby finally realizing the adjustment of the axial position of the blade 14.

[0134] refer to Fig.26In this embodiment, the leaflet cutting device is introduced through the femoral artery. By rotating the bending control handle 30, the distal end of the outer sheath tube 21 can be controlled to bend, so that the distal cutting portion 10 of the leaflet cutting device can smoothly reach the aortic valve 92 along the aortic arch 91. Then, by controlling the middle sheath moving button assembly, the overall posture and angle of the leaflet cutting device are adjusted. By rotating the clamp arm opening and closing knob 46, the clamp arm 15 can be controlled to open and close to clamp and fix the aortic valve 92. Then, the external port 521 can be connected to the power supply to achieve electrical cutting of the leaflets of the aortic valve 92, or the blade moving button assembly can be controlled to move the blade head 14 from the proximal end to the distal end to cut the leaflets of the aortic valve 92, or from the distal end to the proximal end to cut the aortic valve 92. After completing the cutting of the leaflets, the leaflet cutting device withdraws from the human body along the guide wire 80 to facilitate the subsequent surgical process.

[0135] Example 2

[0136] This embodiment provides a leaflet cutting system, including a leaflet cutting device as described in Example 1. Various technical features already included in Example 1 are naturally inherited in this embodiment and will not be repeated.

[0137] In some embodiments, the leaflet cutting system further includes an external power supply device 70, which is used to provide the leaflet cutting device with the high-frequency current required for electrical cutting; the external power supply device 70 has a power regulation function, can adjust the output power according to different cutting requirements, and is equipped with multiple safety protection mechanisms such as overcurrent protection and short circuit protection; the device is provided with a display screen for real-time display of parameters such as output power and impedance, and is provided with a standard interface for connecting the leaflet cutting device. In this embodiment, other specific structures, models, and specifications of the external power supply device 70 are not specifically limited.

[0138] In addition, the leaflet cutting system can also be equipped with a guide wire 80, a catheter, an image guidance device and other medical auxiliary equipment or instruments to assist in completing the surgical operation. Specifically, the operation method of the leaflet cutting device in this embodiment is the same as that in the above embodiment 1, and will not be repeated here.

[0139] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. A leaflet cutting device, characterized in that: The invention comprises a distal cutting portion, wherein the distal cutting portion comprises: -Main body; - a cutting head, arranged inside the main body, wherein at least a part of the cutting head is provided with a conductive material, so as to realize electrical cutting of the leaflet tissue when power is supplied; - a clamping arm, whose proximal end is rotatably connected to the main body, and whose distal end is used to clamp and fix the valve leaflet; - a moving member, which is slidably connected to the clamp arm, and can move axially relative to the main body, and is used to drive the clamp arm to rotate around the main body to achieve opening and closing of the clamp arm; When the clamp arms are closed and the leaflets are fixed, the cutter head performs electrical cutting of the fixed leaflets after being energized.

2. The leaflet cutting device according to claim 1, characterized in that: The cutter head comprises a cutter head body arranged at the distal end and a control rod extending to the proximal end; The blade body is provided with a blade extending radially outward, at least the blade comprises a conductor material, and is used to electrically cut the leaflet tissue when powered on; The control rod comprises a conductive material and is electrically connected to the cutter head body.

3. The leaflet cutting device according to claim 2, characterized in that: The cutter head body further comprises an assembly portion, which is configured as a solid column or a hollow cylinder and is used for being detachably fixedly connected to the distal end of the control rod; The blade is radially arranged outside the mounting portion, and the mounting portion is provided with a conductive material at least in a connection region with the blade.

4. The leaflet cutting device according to claim 3, characterized in that: The blade has a preset protruding height relative to the outer surface of the assembly portion, the bottom of the blade is provided with a first preset thickness, the top of the blade is provided with a second preset thickness, and the second preset thickness is not greater than the first preset thickness.

5. The leaflet cutting device according to claim 4, characterized in that: The cross section of the blade is configured as a triangle, a trapezoid or a rectangle.

6. The leaflet cutting device according to claim 2, characterized in that: The main body comprises: - The main body part is provided with a cutter head guide groove and a hollow inner cavity which are isolated from each other; at least a part of the outer side of the cutter head guide groove is open, and the control rod can control the cutter head body to move axially in the cutter head guide groove and be exposed, so as to realize electrical cutting and / or physical cutting of the leaflet tissue; the hollow inner cavity is provided with a distal opening and a proximal opening for passing a guide wire; - a guide portion connected to the distal opening and communicating with the hollow inner cavity.

7. The leaflet cutting device according to claim 6, characterized in that: The main body portion comprises a rigid material; the guide portion comprises a soft material; and both the main body portion and the guide portion comprise an electrically insulating material.

8. The leaflet cutting device according to claim 6, characterized in that: The clamp arm is connected to the main body by a pivot connection structure to form a rotatable hinge point; a first boss is provided on the proximal side of the hinge point, and the first boss is slidably connected to the movable member; the axial movement of the movable member drives the clamp arm to rotate around the hinge point to achieve opening and closing, and when the clamp arm is in a closed state, the outer surface of the clamp arm and the outer contour of the tool head guide groove are located on the same cylindrical surface.

9. The leaflet cutting device according to claim 8, characterized in that: The inner side of the clamp arm is provided with a barb structure, and the barb structure is used to fix the valve leaflet; the outer side of the clamp arm is provided with a developing ring.

10. The leaflet cutting device according to claim 8, characterized in that: The movable member is sleeved on the proximal outer side of the main member in a cylindrical shape and can move axially along the main member; The outer peripheral surface of the moving part is provided with a notch, which matches the first boss so that the first boss can slide smoothly therein; the notch is arranged obliquely, and the length of the notch matches the maximum opening and closing angle of the clamping arm.

11. The leaflet cutting device according to any one of claims 1 to 10, characterized in that: It also includes a proximal operating part and a catheter part, wherein the proximal end of the catheter part is connected to the proximal operating part, and the distal end of the catheter part is connected to the distal cutting part; The catheter part includes an inner sheath tube, a middle sheath tube and an outer sheath tube in order from the inside to the outside; the distal end of the inner sheath tube is connected to the main body, the distal end of the middle sheath tube is connected to the moving part, and the distal end of the outer sheath tube is used for bending control; The proximal operating part includes a bending control handle and a cutting control handle; the bending control handle is connected to the outer sheath tube and is used to adjust the bending control angle of the distal end of the outer sheath tube; the cutting control handle is used to control the opening and closing of the clamp arm and provide power to the cutter head.

12. The leaflet cutting device according to claim 11, characterized in that: A traction wire is inserted into the outer sheath tube, and the distal end of the traction wire is fixed to the distal end of the outer sheath tube; The bending control handle comprises a first handle shell and a bending control adjustment mechanism disposed in the first handle shell, wherein the bending control adjustment mechanism comprises a threaded moving part, a rotating operating part and a traction wire fixing part; The proximal end of the traction wire passes through the threaded movable part and is fixed to the traction wire fixing part. The distal end of the traction wire fixing part is fixedly connected to the proximal end of the threaded movable part. The threaded movable part is threadedly matched with the rotating operating part. The rotation of the rotating operating part is used to drive the axial movement of the threaded movable part, thereby pulling the traction wire to achieve the bending adjustment of the distal end of the outer sheath tube.

13. The leaflet cutting device according to claim 12, characterized in that: The proximal end of the bending control handle is also provided with a handle tailstock and a limit assembly, and the distal end of the cutting control handle is movably arranged on the handle tailstock; The handle tail seat is fixedly connected to the proximal end of the first handle housing, and the handle tail seat is provided with a first limiting groove and a second limiting groove, wherein the first limiting groove is arranged along the axial direction of the handle tail seat, and the second limiting groove is arranged at the proximal end of the handle tail seat and is arranged circumferentially; The limiting assembly includes a positioning ring and a plurality of limiting rings; Several of the limiting rings are arranged axially, and a second boss is provided on the inner side of the limiting ring, and a limiting groove is provided on the outer side; the second boss cooperates with the first limiting groove to limit the circumferential rotation of the limiting ring, and the limiting groove cooperates with the distal end locking of the cutting control handle to limit the axial movement and circumferential rotation of the cutting control handle relative to the bending control handle; The positioning ring is arranged at the proximal end of the plurality of limiting rings, and a third boss is arranged on the inner side of the positioning ring. The third boss cooperates with the second limiting groove to limit the axial movement of the positioning ring.

14. The leaflet cutting device according to claim 13, characterized in that: The distal end of the cutting control handle is provided with a second handle housing and a middle sheath moving button assembly therein; The second handle housing is sleeved on the outer periphery of the limit assembly and can move axially relative to the limit assembly; The middle sheath moving button assembly comprises: A first movable button inner part, the outer periphery of which is provided with a fourth boss matched with the limiting groove; A first moving button outer part, sleeved on the outer side of the first moving button inner part; The first elastic member is arranged between the first moving button inner member and the first moving button outer member, and is used to keep the fourth boss in locking engagement with the limiting groove.

15. The leaflet cutting device according to claim 14, characterized in that: The cutting control handle also includes a middle sheath fixing member and a clamp arm opening and closing knob arranged at the proximal end of the second handle housing; The middle part of the middle sheath fixing piece is through-through, and the proximal end of the middle sheath tube passes through the second handle shell and is fixedly connected to the middle sheath fixing piece; a fifth boss is also provided on the outer side of the middle sheath fixing piece; The inner circumference of the clamp arm opening and closing knob is provided with an internal thread that cooperates with the cutting control handle thread, and is also provided with an annular groove that cooperates with the fifth boss, and the fifth boss can rotate circumferentially in the annular groove; the rotation of the clamp arm opening and closing knob is used to drive the axial movement of the middle sheath fixing part, thereby controlling the axial displacement of the moving part relative to the main body.

16. The leaflet cutting device according to claim 15, characterized in that: The cutting control handle also includes an inner sheath fixing member and a circuit control component; The inner sheath is configured as a double-lumen tube, including a first lumen and a second lumen, wherein the first lumen and the second lumen are separately arranged at the proximal end, the first lumen is used for passing a guide wire, and the second lumen is used for passing a control rod of the knife head; The inner sheath fixing part is fixedly arranged in the cutting control handle, and the separated first cavity and the second cavity are both passed through the inner sheath fixing part and fixedly connected thereto; The circuit control assembly is electrically connected to the control rod and is provided with an external connection port for electrically connecting to an external power supply device.

17. The leaflet cutting device according to claim 16, characterized in that: The proximal end of the cutting control handle is provided with a proximal external thread, and the proximal end of the cutting control handle also includes a third handle housing and a cutter head moving button assembly disposed therein; The cutter head movement button assembly includes: A cutter head fixing member, fixedly connected to the proximal end of the control rod; A second moving button inner part, the outer periphery of which is provided with an inner thread matching the proximal outer thread; A second moving button outer part is sleeved on the outer side of the second moving button inner part; a second elastic member, disposed between the second moving button inner member and the second moving button outer member; Among them, when the second movable button outer part is pressed, the second elastic part is compressed to make the second movable button inner part disengage from the proximal external thread, and the third handle shell can slide freely in the axial direction; when the movable button outer part is released, the second movable button inner part re-engages with the proximal external thread under the action of the second elastic part, and the axial displacement control of the control rod is realized by rotating the third handle shell.

18. A valve leaflet cutting system, characterized in that: Comprising a leaflet cutting device as described in any one of claims 1-17.

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