A leaflet cutting device and system

Abstract

This invention relates to a leaflet cutting device and system. The device includes: a blade holder with a cutting blade guide groove inside for axial movement of a positive cutting blade; a clamping arm, one end of which is rotatably connected to the blade holder for clamping the leaflet; a positive cutting blade disposed within the blade holder for at least electrical cutting of the leaflet; a negative electrode support, partly disposed within the clamping arm and the other part exposed on the surface of the clamping arm, forming a negative electrode working part; and a current conducting element disposed at the proximal end of the blade holder for electrically connecting the positive cutting blade and the negative electrode support to form a closed circuit, thereby achieving electrical cutting of the leaflet. Compared with the prior art, this invention not only overcomes the defects of needing to attach electrode plates to the patient node and the current needing to travel a long path to complete the cutting, but also enables the current to be precisely conducted only within the leaflet tissue, effectively improving the cutting efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical devices for cardiac surgery, and more particularly to a leaflet cutting device and system. Background Technology

[0002] In recent years, transcatheter heart valve surgery has become an important minimally invasive method for treating valvular diseases. Among these surgeries, leaflet resection is a key step in solving specific clinical problems. Currently, leaflet resection is mainly performed in two ways: purely mechanical resection and electrical resection.

[0003] Purely mechanical cutting methods face many challenges in practice, especially when dealing with autologous leaflets, where the results are less than ideal. Autologous leaflets are composed of dense fibrous connective tissue, which is uneven in thickness and extremely tough. This means that mechanical cutting may apply excessive mechanical force to the autologous tissue during the cutting process, easily causing tissue tearing or damage to surrounding structures, thus increasing surgical risks.

[0004] LAMPOON and other electrocautery techniques involve energizing a guidewire and passing it through the valve leaflets. During this energizing process, the catheter and guidewire are pulled to cut the leaflets. However, existing electrocautery techniques typically require attaching a negative electrode to the patient's back, and the current must flow through human tissue to complete the cutting circuit.

[0005] This traditional electrical cutting design faces two main problems: First, it has low cutting efficiency. Due to the long current path and the need to pass through human tissue, energy loss is significant, resulting in a low proportion of effective current used for cutting, thus affecting surgical efficiency. Second, there is a potential risk of cardiac damage. When the current flows through the heart area, it may cause irreversible damage to myocardial tissue, or even trigger serious complications such as arrhythmias. In addition, the uncontrolled spread of the current may also cause accidental damage to surrounding healthy tissues.

[0006] Therefore, improving the efficiency of leaflet removal while reducing potential harm to patients, thereby enhancing the success rate and safety of transcatheter heart valve surgery, has become an urgent technical problem to be solved. Summary of the Invention

[0007] This invention discloses a 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 one hand, the present invention provides a leaflet cutting device, comprising:

[0010] - The cutter holder has a cutting guide groove inside for the axial movement of the positive cutting cutter;

[0011] - A clamping arm, one end of which is rotatably connected to the blade holder, is used to clamp the leaflets;

[0012] - Positive cutting blade, housed within the blade holder, for at least electrical cutting of leaflets;

[0013] - The negative electrode support has one part set inside the clamping arm and the other part exposed on the surface of the clamping arm, forming the negative electrode working part;

[0014] - A current conductor, located near the blade holder, is used to electrically connect the positive cutting blade with the negative support to form a closed circuit, thereby achieving electric cutting of the leaflets.

[0015] As a preferred technical solution, the positive electrode cutting tool includes a cutting control unit and a cutting head;

[0016] The cutting control unit extends axially and is capable of axial movement. The blade head is fixedly located at the far end of the cutting control unit. Both the cutting control unit and the blade head include conductive material and are electrically connected to form a closed circuit with the negative electrode support when energized, thereby realizing the electro-cutting of the leaflet tissue.

[0017] As a preferred technical solution, at least a portion of the area surrounding the positive electrode cutting blade includes insulating material to electrically isolate the positive electrode cutting blade from other components of the leaf cutting device, ensuring that current flows only through a preset circuit path.

[0018] As a preferred technical solution, the blade head is provided with double-sided cutting edges, with the outer cutting edge of the double-sided cutting edges facing the distal end and the inner cutting edge of the double-sided cutting edges facing the proximal end, and at least one cutting edge of the double-sided cutting edges is configured as a conductive material.

[0019] As a preferred technical solution, the tool holder includes a cutting tool guide groove and a wire guide cavity, which extend axially and are arranged in parallel.

[0020] The guidewire lumen is used for inserting the guidewire;

[0021] At least a portion of the cutting blade guide groove is open, allowing at least a portion of the cutting control unit to be exposed and forming an electric field contact area with the negative electrode bracket, thereby optimizing the current path and improving cutting efficiency.

[0022] As a preferred technical solution, the proximal end of the tool holder is provided with a conductive accommodating part, and the inner wall of the conductive accommodating part is provided with an insulated circuit cavity for accommodating the current conductive component;

[0023] The distal end of the current-conducting element is electrically connected to the negative electrode support, and the proximal end of the current-conducting element is electrically connected to the inner sheath.

[0024] As a preferred technical solution, the inner sheath tube has conductive lines and conductive connectors installed inside its wall, and the two are electrically connected.

[0025] The conductive line extends from the proximal end to the distal end of the inner sheath, and the conductive connector is located at the distal end and is electrically connected to the current conductor.

[0026] As a preferred technical solution, the inner sheath tube is further provided with a first insulating cavity and a second insulating cavity, which are arranged in parallel and extend axially.

[0027] The first insulating cavity is connected to the cutting blade guide groove and is used to install the cutting control unit;

[0028] The second insulating cavity is connected to the guide wire cavity and is used for threading the guide wire.

[0029] As a preferred technical solution, an axially movable component is sleeved on the outer side of the conductive receiving part. The proximal end of the movable component is connected to the middle sheath tube, and the distal end of the movable component is connected to the clamping arm through a pivot connection structure to form a rotatable hinge point.

[0030] The axial movement of the moving part can drive the clamping arm to rotate around the hinge point, thus opening and closing. When the clamping arm is in the closed state, the outer surface of the clamping arm and the outer contour of the tool holder are on the same cylindrical surface.

[0031] As a preferred technical solution, the distal end of the current conducting member is provided with a first protrusion, and the proximal end of the clamping arm is provided with an inclined slot. The slot matches the first protrusion, and the axial movement of the moving member can drive the first protrusion to slide smoothly in the slot.

[0032] The length of the slot is matched with the maximum opening angle of the clamping arm.

[0033] As a preferred technical solution, the negative electrode bracket is axially disposed on the inner surface of the clamping arm, and the proximal end of the negative electrode bracket is disposed in the slot and electrically connected to the first protrusion.

[0034] As a preferred technical solution, the inner surface of the clamping arm is provided with a negative electrode receiving groove in the axial direction. The negative electrode receiving groove is open, so that the negative electrode support can be exposed in the axial direction, ensuring that the positive electrode cutting blade maintains the optimal electric field distance with the negative electrode support during the movement of the positive electrode cutting blade.

[0035] As a preferred technical solution, the clamping arm is provided with multiple barbs on both sides. The barbs are distributed along the axial direction of the clamping arm and are adapted to the anatomical structure of the leaflet. This allows the effective cutting area of ​​the leaflet to be precisely aligned with the head of the positive electrode cutting blade when the leaflet is clamped, thereby improving the cutting energy efficiency.

[0036] On the other hand, the present invention also provides a leaflet cutting system, including the leaflet cutting device as described in any of the preceding claims, and further including an electrical power control device;

[0037] The power control device is electrically connected to the proximal end of the leaflet cutting device. The power control device is used to provide the power required for electric cutting and to adjust the frequency, amplitude and waveform of the output current according to the preoperative settings.

[0038] The technical solution adopted in this invention can achieve the following beneficial effects:

[0039] This invention mainly provides a leaflet cutting device and system. The device includes a blade holder, a clamping arm, a positive electrode cutting blade, a negative electrode support, and a current conducting element. The rotatable connection between the blade holder and the clamping arm enables precise clamping and positioning of the leaflet. The positive electrode cutting blade is preferably configured with double-sided blades, which, in conjunction with the barbed structure on the inner side of the clamping arm, makes the cutting operation more flexible and precise.

[0040] The positive electrode cutting blade and the negative electrode support form a closed circuit through a current conduction component, enabling highly efficient electrical cutting of the valve leaflets. Compared with existing technologies, this not only overcomes the shortcomings of traditional electrical cutting techniques, such as the need to attach electrode plates to the patient's nodes and the need for the current to travel a long path to complete the cutting, but also ensures that the current is precisely conducted only within the valve leaflet tissue, effectively improving cutting efficiency and avoiding energy loss caused by excessively long current paths. At the same time, since the current does not need to pass through other areas of the heart, the risk of irreversible damage to myocardial tissue is greatly reduced. In addition, the insulating material around the device ensures that the current flows only through a preset path, thereby effectively preventing uncontrolled current diffusion and avoiding accidental damage to surrounding healthy tissues. Attached Figure Description

[0041] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0042] Figure 1 This is a schematic diagram of the structure of the leaflet cutting device in one embodiment of the present invention;

[0043] Figure 2 This is a schematic diagram of the leaf cutting device in one embodiment of the present invention when the clamping arm is open;

[0044] Figure 3 This is a cross-sectional view of the leaflet cutting device in one embodiment of the present invention;

[0045] Figure 4 This is a schematic diagram of the inner sheath tube in one embodiment of the present invention;

[0046] Figure 5 for Figure 4 Sectional view along axis AA;

[0047] Figure 6 This is a schematic diagram of the structure of the positive electrode cutting blade in one embodiment of the present invention;

[0048] Figure 7 This is a schematic diagram of the tool holder structure in one embodiment of the present invention;

[0049] Figure 8 This is a cross-sectional view of the tool holder in one embodiment of the present invention (Example 1).

[0050] Figure 9 This is a schematic diagram of the current conducting element in one embodiment of the present invention;

[0051] Figure 10 This is a schematic diagram of the structure of the moving part in one embodiment of the present invention;

[0052] Figure 11 This is a cross-sectional view of the moving part in one embodiment of the present invention (Example 1).

[0053] Figure 12 This is a schematic diagram of the clamping arm structure in one embodiment of the present invention;

[0054] Figure 13 This is a three-dimensional structural diagram of the clamping arm in one embodiment of the present invention;

[0055] Figure 14 This is a schematic diagram of the negative electrode support structure in one embodiment of the present invention;

[0056] Figure 15 This is a combined state diagram of the leaflet cutting system in one embodiment of the present invention, which is an example of the second embodiment of the present invention.

[0057] Explanation of reference numerals in the attached figures:

[0058] The components include: a blade holder 10, a guide head 11, a cutting blade guide groove 12, a blade head concealment cavity 13, a wire guide cavity 14, a conductive receiving part 15, a clamping arm 20, a negative electrode receiving groove 21, a barb 22, a hinge point 23, a slot 24, a positive electrode cutting blade 30, a cutting control part 31, a blade head 32, an outer blade 321, an inner blade 322, a negative electrode support 40, a current conducting component 50, a first boss 51, a moving component 60, an inner sheath tube 70, a first insulating cavity 71, a second insulating cavity 72, a conductive line 73, a conductive connector 74, and an electrical power control device 80. Detailed Implementation

[0059] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0060] In the description of this invention, 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 for distinguishing 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 leaflet cutting device, and the term "distal end" refers to the end farther from the operator along the length direction of the leaflet cutting device.

[0061] 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 the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of the present invention. Example 1

[0062] In heart valve diseases, when thickening, fusion, or calcification of the valve leaflets obstructs blood flow, or when valvular insufficiency causes blood reflux, precise cutting of the valve leaflets is required to restore normal blood flow. To address the problems of existing valve leaflet cutting techniques, this embodiment provides a valve leaflet cutting device suitable for minimally invasive interventional treatment of various heart valve stenosis or insufficiency, such as the mitral, tricuspid, and aortic valves.

[0063] refer to Figure 1 — Figure 14The distal end of the leaflet cutting device is provided with a blade holder 10, a clamping arm 20, a positive electrode cutting blade 30, a negative electrode support 40, and a current conductor 50. The blade holder 10 is provided with a cutting blade guide groove 12 for axial movement of the positive electrode cutting blade 30. The positive electrode cutting blade 30 can form a positive electrode working part within the blade holder 10 and perform electrical cutting on the leaflet. More preferably, it can also perform mechanical cutting. One end of the clamping arm 20 is selectively connected to the blade holder 10 for clamping the leaflet. A portion of the negative electrode support 40 is disposed inside the clamping arm 20, and another portion is exposed on the inner surface of the clamping arm 20 to form a negative electrode working part. The current conductor 50 is disposed at the proximal end of the blade holder 10 for electrically connecting the positive electrode cutting blade 30 and the negative electrode support 40 to form a closed circuit for realizing electrical cutting of the leaflet. This device is preferably delivered to the target valve location via catheter intervention. It uses electrocautery to precisely cut specific leaflet areas, avoiding the trauma of traditional open-heart surgery. At the same time, it overcomes the problems of long current paths, large energy losses, and high risk of damage to surrounding tissues in existing electrocautery techniques, providing a safer and more efficient treatment option for patients with valvular disease.

[0064] In some embodiments, the leaflet cutting device further includes an inner sheath 70, a middle sheath (not shown in the figure), and a movable member 60. The inner sheath 70 is inserted inside the middle sheath, and the two are axially movable relative to each other, with their proximal ends extending to the surgical operating end outside the body. The distal end of the inner sheath 70 is fixedly connected to the blade holder 10. The distal end of the middle sheath is fixedly connected to the movable member 60, which is axially movable and sleeved on the proximal end of the blade holder 10. The distal end of the movable member 60 is connected to the clamping arm 20 through a pivot connection structure, forming a rotatable hinge point 23. The axial movement of the movable member 60 can drive the clamping arm 20 to rotate around the hinge point 23, thereby opening and closing. When the clamping arm 20 is in the closed state, the outer surface of the clamping arm 20 and the outer contour of the blade holder 10 are located on the same cylindrical surface, so as to minimize the stimulation and damage to the blood vessel wall when the device is delivered in the blood vessel.

[0065] like Figure 7 , Figure 8 In some embodiments, in addition to the cutting blade guide groove 12, the cutter holder 10 is also provided with an axially penetrating wire guide cavity 14 for threading the wire. The wire guide cavity 14 is preferably located in the middle of the cutter holder 10 and is parallel to and isolated from the cutting blade guide groove 12. Preferably, the distal end of the cutter holder 10 is also provided with a guide head 11, which is generally conical with a blunt end and has a hollow cavity inside, and the cavity is connected to the wire guide cavity 14 of the cutter holder 10.

[0066] In some embodiments, the guide head 11 is made of a soft material, which can reduce the risk of irritation and potential damage to the blood vessel wall, and better adapt to the curvature and changes of the blood vessel, thereby improving the passability of the device.

[0067] In some embodiments, the guide head 11 is injection molded from a soft insulating material, and the blade holder 10 is injection molded from an insulating, high-hardness material. The insulating guide head 11 and blade holder 10 can prevent current leakage during electric cutting and avoid accidental damage to surrounding healthy tissues.

[0068] like Figure 4 , Figure 5 In some embodiments, the inner sheath 70 has an axially extending first insulating cavity 71 and a second insulating cavity 72, which are parallel and isolated from each other. Preferably, the first insulating cavity 71 is connected to the cutting blade guide groove 12; the second insulating cavity 72 is connected to the guide wire cavity 14 for threading the guide wire. In some embodiments, the inner sheath 70 also has a conductive line 73 and a conductive connector 74 inside its wall, which are electrically connected. The conductive line 73 extends from the proximal end to the distal end of the inner sheath 70, and the conductive connector 74 is located at the distal end and is electrically connected to the current conducting element 50.

[0069] In some embodiments, the inner sheath 70 is made of medical-grade insulating material to ensure that current is not conducted through the inner sheath 70 to surrounding tissues, thereby improving the electrical safety of the device. The insulating properties of the inner sheath 70, in conjunction with its two internal insulating cavities, form a complete electrical isolation system.

[0070] like Figure 8 In some embodiments, the inner sheath 70 is provided with a hollow cavity, and two insulated conduits are arranged in the hollow cavity, namely a first insulating cavity 71 and a second insulating cavity 72. The two are preferably configured as polyimide tubes (PI tubes). Polyimide material has excellent electrical insulation, thermal stability and mechanical strength, which can effectively ensure the isolated transmission of electrical signals, while maintaining sufficient flexibility to adapt to the navigation needs of complex paths in the cardiovascular system.

[0071] In another embodiment, the first insulating cavity 71 and the second insulating cavity 72 can also be formed directly within the inner sheath tube 70 body made of insulating material, forming two parallel and independent axial channels.

[0072] In some embodiments, the conductive line 73 may be annularly fitted into the inner wall of the inner sheath 70 and extend axially to the distal end of the inner sheath 70. In another embodiment, the conductive line 73 may also be a straight metal wire extending axially, embedded in the wall of the inner sheath 70, and maintained at a certain distance from the inner surface of the wall to ensure electrical insulation.

[0073] The inner sheath 70, as the core current transmission component of the leaflet cutting device, provides isolated current transmission paths for the positive cutting blade 30 and the negative support 40, ensuring precise current transmission to the distal working area of ​​the device, forming a stable electric field, achieving efficient electro-cutting of the leaflet tissue, and allowing the current to flow directionally within a pre-defined circuit. Simultaneously, the insulating structure of the inner sheath 70 effectively prevents current leakage, avoiding accidental damage to surrounding cardiac tissue and significantly improving surgical safety. Furthermore, the second insulating cavity 72 within the inner sheath 70 provides a stable guiding channel for the guidewire, enabling the entire device to precisely reach the target treatment site.

[0074] like Figure 6 In some embodiments, the positive electrode cutting blade 30 includes a cutting control unit 31 and a blade head 32, both made of conductive material and electrically connected. The cutting control unit 31 extends axially within the first insulating cavity 71, with its proximal end externally disposed and connected to an external power control device 80 to supply power to the blade head 32. It can also be moved by axial pushing and pulling. Its distal end extends out of the first insulating cavity 71 and is placed within the cutting blade guide groove 12. The blade head 32 is fixedly disposed at the distal end of the cutting control unit 31 and, when energized, forms a closed circuit with the negative electrode support 40 to achieve electro-cutting of the leaflet tissue.

[0075] In some embodiments, the positive electrode cutting blade 30 is made of medical-grade high-conductivity metal alloys, such as stainless steel, titanium alloys, or nickel-titanium alloys. These materials not only have excellent conductivity but also good biocompatibility and mechanical strength.

[0076] In some embodiments, the cutting control unit 31 has a slender and flexible structure that can adapt to the anatomical path of the blood vessel's curvature while maintaining sufficient pushing force and anti-torsion performance. The positive electrode cutting blade 30 is not limited to electrical cutting; in the power-off state, it can also be used as a mechanical cutting tool. Through the combined cutting action of axial advancement and retraction, it can cope with valve tissues of different thicknesses and hardness, improving the adaptability and efficiency of the surgery.

[0077] In some embodiments, the blade head 32 is provided with two blades, and at least one of the blades is configured as a conductive material.

[0078] When only one side of the blade is made of a conductive material, the other side may be made of a non-conductive material or coated with an insulating layer. This asymmetrical structure allows the current to be concentrated on the conductive side of the blade to form a directional electric field, which is suitable for cutting scenarios that require protection of tissues in a specific direction.

[0079] When both blades are made of conductive material, a more uniform electric field distribution can be formed around the blade tip, achieving an all-around electrical cutting effect and improving cutting efficiency and uniformity. Furthermore, double-sided conductive blades are more adaptable to certain complex anatomical structures, enabling wider tissue cutting in a single contact, reducing the number of steps and improving surgical precision.

[0080] In some embodiments, the two blades are inclined, with the outer blade 321 facing the distal end and the inner blade 322 facing the proximal end. When mechanically cutting the leaflets, the two blades can cut the leaflets in different directions to adapt to the cutting requirements of different directions and positions, as well as leaflet tissues of different thicknesses and hardness.

[0081] For example, when the starting position of the cutter head 32 is at the far end of the cutter head guide groove, after capturing the leaflet, the cutter head 32 is pulled back to the proximal end, and the inner cutting edge 322 can cut from the root of the leaflet; when the starting position of the cutter head 32 is at the proximal end of the cutter head guide groove, after capturing the leaflet, the cutter head 32 is pushed to the far end, and the outer cutting edge 321 can cut from the mating edge of the leaflet, thereby achieving partial cutting of the leaflet.

[0082] In some embodiments, in order to achieve a concealed structure for the blade head 32 and ensure smooth movement of the blade head 32, the height of the blade head 32 is less than the radius of the blade holder 10; preferably, a blade head concealment cavity 13 is also provided at the far end of the cutting blade guide groove 12, the length of the blade head concealment cavity 13 is not less than the length of the blade head 32, and the height of the blade head concealment cavity 13 is greater than the height of the blade head 32. During the transport process, the blade head 32 is located in the blade head concealment cavity 13 to reduce the risk of tissue damage due to accidental exposure of the blade head 32 during transport.

[0083] In some embodiments, at least a portion of the cutting blade guide groove 12 is open on the side facing the clamping arm 20, allowing the cutting control unit 31 to be directly exposed in this area. This creates the shortest and most direct electric field path between the cutting control unit 31 and the negative electrode support 40, thereby reducing resistance and energy loss, and thus improving the efficiency and accuracy of the electrical cutting. Furthermore, the open cutting blade guide groove 12 also allows the electric field to act more concentratedly on the target leaflet tissue, reducing thermal effects and current diffusion on surrounding healthy tissue.

[0084] In some embodiments, the open configuration of the cutting blade guide groove 12 refers to removing part of the groove wall material in a specific area of ​​the cutting blade guide groove 12 to form a circumferential opening structure. Specifically, the opening angle of this opening structure in the circumferential direction is preferably between 30° and 180°. This angle range ensures that the cutting control unit 31 has sufficient exposed area to form an effective electric field with the negative electrode support 40, and also ensures that the blade head 32 maintains stable axial sliding within the cutting blade guide groove 12 without deflection or jamming.

[0085] In some embodiments, the axial distribution of the open sections can be designed according to different clinical needs. In some embodiments, the open sections can be located at the proximal or distal portion of the cutting blade guide groove 12 to facilitate the formation of a stable electric field at the initial or final stage of cutting; in other embodiments, the cutting blade guide groove 12 can also adopt a fully open structure to ensure that a consistent electric field strength is maintained throughout the cutting process.

[0086] In some embodiments, at least a portion of the periphery of the positive electrode cutting blade 30 includes an insulating material for electrically isolating the positive electrode cutting blade 30 from other components of the leaf cutting device, ensuring that current flows only through a predetermined circuit path.

[0087] Specifically, the insulation treatment around the positive electrode cutting blade 30 is mainly for other components of the leaf cutting device that are in direct contact with the cutting blade. These contact components include, but are not limited to, the inner wall of the cutting blade guide groove 12, the internal structure of the blade holder 10, and the end of the inner sheath tube 70 that may come into contact with the cutting blade. The surfaces of these components are made of high-performance insulating materials or covered with an insulating layer to ensure that the current will not leak to other structural components of the device through unexpected paths during the movement and operation of the positive electrode cutting blade 30 inside the device.

[0088] By fully insulating the contact parts of the positive electrode cutting blade 30, a complete electrical isolation system can be formed, ensuring that the current flows only from the positive electrode cutting blade 30 to the negative electrode support 40 along a preset circuit path. This significantly improves the accuracy of electrical cutting and the operational safety of the equipment, reduces the risk of electrical damage to non-target tissues, and is crucial for delicate cutting operations in complex cardiac environments.

[0089] refer to Figures 1-3 , Figure 9 In some embodiments, the proximal end of the blade holder 10 is provided with a conductive receiving portion 15, and the inner wall of the conductive receiving portion 15 is provided with an insulated circuit cavity for accommodating the current conductive member 50. The distal end of the current conductive member 50 is electrically connected to the negative electrode support 40, and the proximal end of the current conductive member 50 is electrically connected to the conductive connector 74 in the inner sheath tube 70.

[0090] In some embodiments, the distal end of the current conductor 50 is provided with a first protrusion 51, which is exposed on the outside of the knife holder 10. The proximal end of the clamping arm 20 is provided with an inclined slot 24, which matches the first protrusion 51 and is electrically connected to the negative electrode bracket 40 through the slot 24. In some embodiments, the negative electrode bracket 40 is axially disposed on the inner surface of the clamping arm 20, and the proximal end of the negative electrode bracket 40 is disposed in the slot 24 to achieve electrical connection with the first protrusion 51.

[0091] In some embodiments, the current conducting element 50 has a tubular structure, and the main body is made of a conductive metal material with a certain mechanical strength, such as medical stainless steel; preferably, the current conducting element 50 may be configured with a hollow structure to reduce the weight of the device and facilitate transmission and control in the blood vessel path.

[0092] In some embodiments, the negative electrode support 40 adopts a flat strip design and is made of conductive metal material, which can be the same material as the current conductor 50, such as medical stainless steel; preferably, the negative electrode support 40 may also be configured with a hollow structure to reduce weight.

[0093] In some embodiments, the proximal end of the negative electrode support 40 is disposed inside the clamping arm 20, but the slot 24 is exposed to facilitate electrical connection with the current conductor 50; in some embodiments, the proximal end of the negative electrode support 40 also extends to the hinge point 23 at the proximal end of the clamping arm 20 to enhance the mechanical strength of the hinge point 23.

[0094] like Figures 1-3 , Figures 10-12 In some embodiments, the movable member 60 is sleeved on the outside of the conductive receiving portion 15, and its axial movement can drive the first boss 51 to slide smoothly in the slot 24, always maintaining electrical contact with the near end of the negative electrode bracket 40. At the same time, the clamping arm 20 rotates around the hinge point 23 to realize opening and closing. Figure 2 Specifically, the length of the slot 24 is matched with the maximum opening angle of the clamping arm 20, which not only limits the excessive opening and closing of the clamping arm 20 and protects the tissue from mechanical damage, but also ensures the reliability of the electrical connection at any working angle.

[0095] like Figure 13 , Figure 14In some embodiments, the current conductor 50 and the negative electrode support 40 together constitute the negative electrode circuit of the device. When the device is working, the current is first transmitted from the power control device 80 through the cutting control part 31 in the first insulating cavity 71 of the inner sheath 70 to the blade head 32. The blade head 32 contacts the leaflet tissue and forms an electric field with the negative electrode support 40, realizing tissue electro-cutting in this area. Subsequently, the current flows through the negative electrode support 40 to the proximal slot 24, and is further transmitted through the contact interface formed with the first protrusion 51 in the slot 24. The current continues to flow along the current conductor 50 to the proximal end and reaches the conductive connector 74. Finally, the current enters the conductive line 73 in the inner sheath 70 through the conductive connector 74, completing the entire current closed loop and returning to the power control device 80.

[0096] By setting up a negative electrode bracket 40, a current conduction component 50, a conduction connector 74, and a conductive line 73 inside the inner sheath tube 70, the electrical energy is ensured to flow in a directional and closed loop within the device. The current is transmitted only through the preset conductive components and will not leak to non-target areas. At the same time, during dynamic operations such as bending of the device and opening and closing of the clamping arm 20, a stable and reliable electrical connection can be ensured between each conductive component to guarantee the accuracy and safety of electric cutting.

[0097] In some embodiments, the inner surface of the clamping arm 20 is provided with a negative electrode receiving groove 21 in the axial direction. The negative electrode receiving groove 21 is open in the direction of the positive electrode cutting blade 30, so that the negative electrode support 40 can be exposed in the axial direction and ensure that the positive electrode cutting blade 30 always maintains the optimal electric field action distance with the negative electrode support 40 during the movement.

[0098] Specifically, the negative electrode receiving groove 21 is configured as a semi-open groove structure, which ensures that the negative electrode bracket 40 can be installed stably while maintaining sufficient exposed area; the entire clamp arm 20 or at least the side wall of the receiving groove is made of insulating material to ensure that the current will not leak to other parts of the clamp arm 20, but can only flow along the preset path.

[0099] In some embodiments, the axial length of the negative electrode receiving groove 21 is matched with the working stroke of the cutting blade to ensure a uniform and stable electric field intensity distribution throughout the cutting process. When the positive electrode cutting blade 30 moves axially within the cutting blade guide groove 12, it can always maintain a predetermined optimal electric field interaction distance with the exposed negative electrode support 40, minimizing the range of thermal damage while ensuring cutting efficiency.

[0100] like Figure 12 , Figure 13In some embodiments, the clamping arm 20 is provided with multiple barbs 22 on both sides. The barbs 22 are distributed along the axial direction of the clamping arm 20 and are adapted to the anatomical structure of the target leaflet. When the clamping arm 20 is closed, the leaflet tissue fixed by the barbs 22 automatically aligns with the contact area of ​​the negative electrode support 40, and at the same time forms an ideal cutting line with the expected path of the cutting blade, ensuring that the electric cutting can act on the preset target area to reduce energy loss and thermal effects on non-target areas.

[0101] In some embodiments, the barbs 22 may have a structure including but not limited to serrated, conical, or rake-like shapes, and the barbs 22 on both sides of the clamp arm 20 may be configured in different shapes and / or numbers to suit the anatomical structures of different patients.

[0102] In this embodiment, the above-mentioned leaflet cutting device is operated as follows:

[0103] First, under the guidance of a guidewire, the physician inserts the device into the target heart region via the apex or femoral vein puncture route. Under imaging guidance, the device approaches the target valve. Once the target position is reached, the operator controls the movement of the sheath during operation by the handle to precisely adjust the opening and closing state of the clamp arm 20, so that the clamp arm 20 opens at an appropriate angle to capture the edge of the valve leaflet.

[0104] During the positioning phase, the device uses the barbs 22 on both sides of the clamp arm 20 to fix the leaflet tissue, ensuring that the leaflet remains stable during the cutting process, and the negative electrode support 40 forms a tight contact with the leaflet surface.

[0105] During the cutting process, the operator activates the external electrical control device 80, advancing or retracting the cutting control unit 31, causing the positive electrode cutting blade 30 to move axially along the cutting blade guide groove 12. At this time, a controlled electric field is formed between the blade head 32 of the positive electrode cutting blade 30 and the negative electrode support 40, generating a precise electro-cutting effect in the leaflet tissue. After the cutting is completed and the surgery is finished, the device is completely removed from the patient's body through a catheter. Example 2

[0106] like Figure 15 This embodiment provides a leaflet cutting system, including the leaflet cutting device as described in Embodiment 1, and also includes an electrical control device 80; the various technical features already included in Embodiment 1 are naturally inherited in this embodiment and will not be described again.

[0107] In some embodiments, the power control device 80 is electrically connected to the proximal end of the leaflet cutting device to form a complete closed-loop control system. The power control device 80 is used to provide the electrical energy required for electrical cutting and adjusts the frequency, amplitude, and waveform of the output current according to preoperative settings, allowing the operator to adjust to obtain the optimal combination of electrical parameters according to different leaflet lesion types and tissue characteristics.

[0108] Specifically, the power control device 80 is equipped with a bipolar output port. The positive output terminal forms an electrical path with the proximal end of the cutting control section 31 of the positive cutting blade 30, while the negative output terminal is connected to the conductive line 73 inside the inner sheath 70, thereby forming a complete circuit with the current conduction element 50 and the negative support 40. This separate connection design ensures the directional flow of current within the device and prevents electrical energy from diffusing into non-target areas.

[0109] It should be noted that the core of this embodiment lies in clarifying the functional interface and control logic relationship between the power control device 80 and the leaflet cutting device, rather than being limited to a specific hardware implementation. Therefore, this embodiment does not limit the specific structure, internal components, or hardware specifications of the power control device 80. Those skilled in the art can select existing devices or systems that conform to relevant medical device standards based on clinical needs and technical feasibility, as long as they can achieve the above-mentioned power supply and parameter control functions.

[0110] 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 leaflet cutting device, characterized in that, include: - The cutter holder has a cutting guide groove inside for the axial movement of the positive cutting cutter; - A clamping arm, one end of which is rotatably connected to the blade holder, for clamping the leaflets; -The positive electrode cutting blade is disposed within the blade holder and is used for at least electrically cutting the leaflets; - The negative electrode support has a portion disposed inside the clamping arm and another portion exposed on the inner surface of the clamping arm, forming the negative electrode working part; - A current conductor is disposed at the proximal end of the blade holder; the distal end of the current conductor is electrically connected to the negative electrode support exposed at the proximal end of the clamping arm, and the proximal end of the current conductor is electrically connected to the inner sheath tube, for electrically connecting the positive electrode cutting blade and the negative electrode support to form a closed circuit, so as to realize the electric cutting of the leaflet; The positive electrode cutting blade includes a cutting control section extending along the axial direction. At least a portion of the cutting blade guide groove is open, allowing at least a portion of the cutting control section to be exposed and forming an electric field contact area with the negative electrode support.

2. The leaflet cutting device according to claim 1, characterized in that, The positive electrode cutting blade includes the cutting control unit and the blade head; The cutting control unit extends axially and is capable of axial movement. The blade head is fixedly disposed at the distal end of the cutting control unit. Both the cutting control unit and the blade head include conductive material and are electrically connected to each other, so as to form a closed circuit with the negative electrode support when energized, thereby realizing the electrocutting of the leaflet tissue.

3. The leaflet cutting device according to claim 2, characterized in that, At least a portion of the area surrounding the positive electrode cutting blade includes insulating material to electrically isolate the positive electrode cutting blade from other components of the leaf cutting device, ensuring that current flows only through a preset circuit path.

4. The leaflet cutting device according to claim 2, characterized in that, The blade head has double-sided cutting edges, with the outer cutting edge facing the distal end and the inner cutting edge facing the proximal end. At least one of the double-sided cutting edges is configured as a conductive material.

5. The leaflet cutting device according to claim 2, characterized in that, The blade holder includes the cutting blade guide groove and the wire guide cavity, which extend axially and are arranged in parallel. The guide wire cavity is used for inserting the guide wire.

6. The leaflet cutting device according to claim 5, characterized in that, The proximal end of the blade holder is provided with a conductive receiving portion, and the inner wall of the conductive receiving portion is provided with an insulated circuit cavity for accommodating the current conducting element.

7. The leaflet cutting device according to claim 6, characterized in that, The inner sheath tube has conductive lines and conductive connectors installed inside its tube wall, and the two are electrically connected. The conductive line extends from the proximal end to the distal end of the inner sheath, and the conductive connector is disposed at the distal end and electrically connected to the current conductive element.

8. The leaflet cutting device according to claim 6, characterized in that, The inner sheath tube is further provided with a first insulating cavity and a second insulating cavity, which are arranged in parallel and extend axially. The first insulating cavity is connected to the cutting blade guide groove and is used to accommodate the cutting control unit; The second insulating cavity is connected to the guide wire cavity and is used for threading the guide wire.

9. The leaflet cutting device according to claim 6, characterized in that, An axially movable component is sleeved on the outer side of the conductive receiving part. The proximal end of the movable component is connected to the middle sheath tube, and the distal end of the movable component is connected to the clamping arm through a pivot connection structure to form a rotatable hinge point. The axial movement of the moving part can drive the clamping arm to rotate around the hinge point to achieve opening and closing. When the clamping arm is in the closed state, the outer surface of the clamping arm and the outer contour of the tool holder are located on the same cylindrical surface.

10. The leaflet cutting device according to claim 9, characterized in that, The distal end of the current conducting member is provided with a first protrusion, and the proximal end of the clamping arm is provided with an inclined slot. The slot matches the first protrusion, and the axial movement of the moving member can drive the first protrusion to slide smoothly in the slot. The length of the slot is matched with the maximum opening angle of the clamping arm.

11. The leaflet cutting device according to claim 10, characterized in that, The negative electrode bracket is axially disposed on the inner surface of the clamping arm, and the proximal end of the negative electrode bracket is disposed in the slot and is electrically connected to the first boss.

12. The leaflet cutting device according to claim 11, characterized in that, The inner surface of the clamping arm is provided with a negative electrode receiving groove in the axial direction. The negative electrode receiving groove is open, so that the negative electrode support can be exposed in the axial direction, ensuring that the positive electrode cutting blade maintains the optimal electric field distance with the negative electrode support during the movement of the positive electrode cutting blade.

13. The leaflet cutting device according to claim 11, characterized in that, The clamping arm has multiple barbs on both sides, which are distributed along the axial direction of the clamping arm and adapted to the anatomical structure of the leaflet. This allows the effective cutting area of ​​the leaflet to be precisely aligned with the head of the positive electrode cutting blade when the leaflet is clamped, thereby improving cutting energy efficiency.

14. A leaflet cutting system, characterized in that, The device includes the leaflet cutting apparatus as described in any one of claims 1-13, and further includes an electrical power control device; The power control device is electrically connected to the proximal end of the leaflet cutting device. The power control device is used to provide the power required for electric cutting and to adjust the frequency, amplitude and waveform of the output current according to the preoperative settings.

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