Transcatheter leaflet cutting device and system

Abstract

The present application relates to a kind of transcatheter leaflet cutting device and system, the device includes remote cutting part, remote cutting part is equipped with main body piece, clamping arm and cutting knife, clamping arm is rotatably connected with main body piece, to hold fixed leaflet tissue, cutting knife is used to realize the electric cutting of fixed leaflet tissue when energized;At least part of section of cutting knife is equipped with reinforcing layer, to enhance the surface structure intensity of cutting knife;At least part of section of cutting knife is equipped with anti-adhesion heat insulation layer, to realize low-temperature cutting, and prevent tissue adhesion;At least part of section of cutting knife is equipped with insulating layer, to isolate radio frequency current.

Description

Technical Field

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

[0002] Transcatheter aortic valve replacement (TAVR / TMVR) has become an important treatment for diseases such as aortic stenosis. However, before implanting a new artificial valve, the original autologous or deteriorated bioprosthetic leaflets may be pushed into the coronary artery ostium or left ventricular outflow tract, leading to serious complications such as coronary artery obstruction or left ventricular outflow tract obstruction. To address this issue, valve reshaping techniques have been developed clinically. These involve pre-cutting the leaflets that may cause obstruction before implanting a new valve, thus creating a pathway for blood flow. Currently, techniques such as BASILICA often utilize guidewires combined with radiofrequency ablation for cutting; however, existing techniques have significant limitations.

[0003] First, the surgery is performed in the bloodstream, where conductivity is higher than that of valve tissue. Traditional cutting tips lack insulation, resulting in significant loss of radiofrequency current and low energy efficiency. Simultaneously, traditional electrosurgical units operate at temperatures as high as 200-270℃, easily causing tissue charring, carbonization, and thermal damage to surrounding healthy tissue. Furthermore, tissue adhesion caused by high temperatures reduces cutting smoothness and increases the risk of accidental tearing.

[0004] Secondly, the fit between the cutting head and the valve leaflet directly affects the surgical precision. Current delivery sheaths have limited bending capabilities, typically only 0-180°, making them unsuitable for complex anatomical structures such as transverse hearts. In such cases, the limited bending angle cannot guarantee good coaxiality between the cutting head and the target valve leaflet, easily leading to incomplete cutting or accidental damage to surrounding tissues.

[0005] Furthermore, existing leaflet cutting instruments typically consist of two or three independent sections as their control handles. This segmented design is not only structurally complex, but the gaps in the connections and transmissions between the sections can lead to poor control precision, affecting the surgeon's accurate manipulation of the distal actuators. For example, when multiple degrees of freedom such as bending, clamp opening and closing, and blade cutting need to be controlled simultaneously, the segmented handle cannot provide an integrated, efficient, and precise operating experience, hindering its clinical promotion and application. Summary of the Invention

[0006] This invention discloses a transcatheter valve leaflet cutting device and system, aiming to solve the technical problems existing in the prior art. The invention adopts the following technical solution: On one hand, embodiments of the present invention provide a transcatheter valve leaflet cutting device, including a distal cutting part, the distal cutting part having a main body, a clamping arm and a cutting blade, the clamping arm being rotatably connected to the main body to clamp and fix the valve leaflet tissue, and the cutting blade being used to electrically cut the fixed valve leaflet tissue when energized. The cutting blade has a reinforcing layer in at least a portion of its section to enhance the surface structural strength of the cutting blade; an anti-adhesion and heat-insulating layer in at least a portion of its section to enable low-temperature cutting and prevent tissue adhesion; and an insulating layer in at least a portion of its section to isolate radio frequency current.

[0007] As a preferred technical solution, the cutting blade includes a blade head body and a control lever connected thereto, and the blade head body is provided with a cutting edge; At least a portion of the blade is provided with a reinforcing layer and an anti-adhesion heat insulation layer to enhance the structural strength of the blade and achieve low-temperature cutting and prevent tissue adhesion; The cutter head body, excluding the cutting edge, has at least a reinforcing layer, an insulating layer, and an anti-sticking heat insulation layer in sequence to enhance structural strength, isolate current, and achieve low-temperature cutting. At least a portion of the control lever is provided with an insulating layer to isolate the energy loss of radio frequency current during transmission.

[0008] As a preferred technical solution, the reinforcing layer includes a metal coating, a ceramic coating, or a diamond-like coating; the insulating layer includes a medical polymer coating; and the anti-sticking and heat-insulating layer includes a fluoropolymer coating or a metal oxide coating.

[0009] As a preferred technical solution, the thickness of the reinforcing layer is 0.1μm-5μm; the thickness of the insulating layer is 5μm-20μm; and the thickness of the anti-sticking heat insulation layer is 5μm-20μm.

[0010] As a preferred technical solution, it also includes a catheter section, which comprises, from the inside out: The inner sheath is connected to the main body at its distal end and is provided with cavities for the movement of the guide wire and the control rod. The middle sheath is connected to the clamping arm drive at the distal end to control the opening and closing of the clamping arm; The outer sheath extends distally to the proximal end of the distal cut portion, and the outer sheath is configured to be continuously controllable to bend by at least 270°.

[0011] As a preferred technical solution, the inner wall of the outer sheath tube is provided with a flexible reinforcing metal layer and a traction wire. The reinforcing metal layer includes a first bending section, a second bending section and a support section from the distal end to the proximal end. The traction wire is fixed to the distal end of the first bending section and drives the bending of at least the first bending section and the second bending section. Among them, the bending performance of the first bending section is better than that of the second bending section, and the bending performance of the second bending section is better than that of the support section.

[0012] As a preferred technical solution, the first bending section has a higher cutting density and / or lower structural strength and / or lower bending stiffness; and the axial length of the first bending section is greater than the axial length of the second bending section.

[0013] As a preferred technical solution, the reinforcing metal layer is further provided with a bending transition section between the first bending section and the second bending section, and the cutting density, structural strength and / or bending stiffness of the bending transition section are between those of the first bending section and the second bending section.

[0014] As a preferred technical solution, it also includes a proximal operating handle, which is connected to the proximal end of the catheter portion; the proximal operating handle includes: The bending control section is used to control the axial movement of the traction wire in order to adjust the bending angle of the distal end of the outer sheath. The middle sheath locking part is used to selectively lock the axial movement of the middle sheath; The cutting blade locking part is used to lock the cutting blade in the conveying state and unlock it in the cutting state to allow the cutting blade to move axially.

[0015] As a preferred technical solution, the bending control part is located at the distal end of the proximal operating handle and extends outward at an angle relative to the central axis of the proximal operating handle. The bending control part includes a rotating operating component, a threaded moving component, and a traction wire fixing component; the distal end of the traction wire fixing component abuts against the proximal end of the threaded moving component, the threaded moving component is threadedly engaged with the rotating operating component, the rotating operating component is rotatably mounted on the distal body of the proximal operating handle, and the rotation of the rotating operating component can drive the threaded moving component and the traction wire fixing component to move axially, so as to pull the traction wire to achieve bending.

[0016] As a preferred technical solution, the middle sheath locking part is located in the middle of the proximal operating handle and is coaxial with the central axis of the proximal operating handle; The locking part of the middle sheath includes a knob and a clamping member; the knob is rotatably mounted on the distal body of the proximal operating handle, and the clamping member is driven to engage with the knob; the rotation of the knob can drive the clamping member to retract radially to limit the middle sheath axially and circumferentially, or to expand radially to release the middle sheath.

[0017] As a preferred technical solution, the cutting blade locking part is located at the proximal end of the proximal operating handle and is coaxial with the central axis of the proximal operating handle; The cutting blade locking part includes a locking member, which is connected to the proximal end of the control lever, and the outer periphery of the locking member is provided with at least one protrusion; The proximal body of the proximal operating handle is provided with a guide groove that mates with the protrusion. The guide groove includes a first circumferential section, an axial section, and a second circumferential section that are connected sequentially from the proximal end to the distal end. The protrusion can enter the guide groove from the first circumferential section, move to the distal end along the axial section to the second circumferential section, and after circumferential rotation in the second circumferential section, achieve axial locking of the locking member relative to the proximal operating handle.

[0018] As a preferred technical solution, the outer periphery of the locking member is provided with two protrusions symmetrically in the circumferential direction, and the inner periphery of the proximal body of the proximal operating handle is provided with two guide grooves symmetrically in the circumferential direction.

[0019] On the other hand, embodiments of the present invention also provide a transcatheter leaflet cutting system, including the transcatheter leaflet cutting device as described in any of the preceding claims.

[0020] One embodiment of the above invention has the following advantages or beneficial effects: This invention primarily provides a transcatheter valve leaflet cutting device. By incorporating a reinforcing layer, an insulating layer, and an anti-adhesion and heat-insulating layer in at least a portion of the cutting blade, it comprehensively achieves multiple technical effects, including enhanced structural strength, isolation of radiofrequency current, and low-temperature anti-adhesion. Specifically, the reinforcing layer effectively enhances the surface strength of the cutting blade, improving its wear resistance and service life; the insulating layer isolates the energy loss of radiofrequency current during transmission, preventing current diffusion through the blood and concentrating energy in the blade area, thereby significantly improving energy utilization efficiency; the anti-adhesion and heat-insulating layer has extremely low surface energy and excellent heat insulation performance, significantly reducing the cutting temperature to 40-70℃. This effectively avoids irreversible thermal damage to adjacent healthy tissues such as the valve annulus, aortic wall, and conduction system caused by the high temperature of traditional electrosurgical units, while also preventing tissue adhesion problems caused by protein denaturation, making the cutting process smoother and more controllable. This solution, through the synergistic effect of multiple coatings, achieves precise low-temperature cutting without altering the basic structure of existing cutting instruments, making it easy for industrialization and clinical application.

[0021] Furthermore, the transcatheter leaflet cutting device of the present invention is equipped with an outer sheath, which is configured to continuously control the bending angle by at least 270°, greatly improving the device's passability in complex vascular pathways. The flexible reinforcing metal layer within its sheath wall, through a segmented design, includes a first bending segment, a second bending segment, and a support segment with progressively decreasing bending performance. A bending transition segment can be further provided between the first and second bending segments, achieving smooth and continuous morphological adjustment of the distal cutting section. This allows the distal cutting section to maintain good coaxiality and fit with the target leaflet, making it particularly suitable for complex anatomical structures such as transverse hearts where the angle between the long axis of the heart and the longitudinal axis of the body is significantly increased. It effectively avoids incomplete cutting, leaflet tearing, or accidental damage to surrounding tissues caused by the distal cutting section's tilted contact with the leaflet, significantly improving the applicability and safety of the procedure.

[0022] Furthermore, the transcatheter valve cutting device of this invention employs a proximal operating handle integrating a bending control section, a middle sheath locking section, and a cutting blade locking section, achieving precise control of multiple degrees of freedom through an integrated structure. Specifically, the bending control section, through the cooperation of a rotating operating component and a threaded moving component, can precisely control the tension of the traction wire, enabling fine adjustment of the bending angle; the middle sheath locking section, through the threaded cooperation of a knob and a clamping component, can lock or release the middle sheath at any time during surgery, improving the stability of clamping and cutting operations; the cutting blade locking section, through the cooperation of a protrusion on the locking component and a guide groove, can reliably lock the cutting blade in the transport state to ensure safety, and can quickly unlock in the cutting state to achieve axial movement of the blade head. Compared to the segmented control handles in the prior art, this integrated control handle structure of the present invention has a higher degree of integration, effectively overcoming the problems of large connection gaps and inconvenient control associated with segmented handles, and improving the overall efficiency and safety of surgical operations. Attached Figure Description

[0023] 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: Figure 1 This is a schematic diagram of the transcatheter valve leaflet cutting device disclosed in one embodiment of the present invention; Figure 2 for Figure 1 A magnified view of a section at point A in the middle; Figure 3 This is a schematic diagram of the structure of a cutting blade disclosed in one embodiment of the present invention; Figure 4 for Figure 3 BB section diagram; Figure 5 for Figure 3 CC section diagram in the image; Figure 6 This is a schematic diagram of the internal structure of the outer sheath tube disclosed in one embodiment of the present invention; Figure 7 This is a schematic diagram of the outer sheath tube bent 180° in one embodiment of the present invention; Figure 8 This is a schematic diagram showing the outer sheath tube bent at more than 270° in one embodiment of the present invention; Figure 9 This is a schematic diagram of the proximal operating handle disclosed in one embodiment of the present invention; Figure 10 This is a cross-sectional view of the proximal operating handle disclosed in one embodiment of the present invention; Figure 11 This is a schematic diagram of the structure of the middle sheath locking part disclosed in one embodiment of the present invention; Figure 12 This is a schematic diagram of the operation of the middle sheath locking part disclosed in one embodiment of the present invention; Figure 13 This is a cross-sectional view of the proximal body disclosed in one embodiment of the present invention; Figure 14 This is a schematic diagram of the housing of the proximal body disclosed in one embodiment of the present invention; Figure 15 This is a schematic diagram of the structure of a locking member disclosed in one embodiment of the present invention.

[0024] Explanation of reference numerals in the attached figures: The components include: distal cutting section 100, main body 110, moving part 120, slot 121, clamping arm 130, hinge point 131, boss 132, cutting blade 140, blade body 141, blade edge 1411, control rod 142, reinforcing layer 150, anti-adhesion heat insulation layer 160, insulation layer 170, conduit section 200, outer sheath 210, first bending section 211, second bending section 212, support section 213, traction wire 214, middle sheath 220, and inner sheath 2. 30, proximal operating handle 300, distal body 310, rotary operating component 311, threaded moving component 312, traction wire fixing component 313, knob 314, clamping component 315, tapered hole 316, proximal body 320, middle sheath tube adjusting knob 321, middle sheath tube fixing component 322, locking component 323, protrusion 3231, first circumferential section 324, axial section 325, second circumferential section 326, control rod fixing component 327, axial extension tube 328. Detailed Implementation

[0025] 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.

[0026] 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 along the length direction of the transcatheter valve leaflet cutting device that is closer to the operator, and the term "distal end" refers to the end along the length direction of the transcatheter valve leaflet cutting device that is farther from the operator.

[0027] 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.

[0028] Currently, although existing transcatheter leaflet resection devices can achieve basic leaflet resection functions, they still have significant shortcomings in practical applications. First, leaflet resection surgery is performed in a blood-filled environment, and the conductivity of blood is much higher than that of leaflet tissue. Traditional cutting instruments lack effective insulation design on the blade tip, causing most of the radiofrequency current to leak through the blood from the side of the blade tip, failing to concentrate on the cutting edge, resulting in low energy utilization efficiency and affecting cutting efficiency. At the same time, traditional radiofrequency electrosurgical units operate at extremely high temperatures, typically reaching 200-270℃ or even higher. This not only causes tissue charring and carbonization, but more importantly, the high temperature diffuses to healthy tissue on both sides of the cutting path, causing irreversible thermal damage to the valve annulus, aortic wall, and conduction system. In addition, the high temperature can denature proteins, causing tissue to adhere to the blade tip surface, which not only affects the smoothness of the cutting but may also cause accidental tissue tearing due to traction.

[0029] Furthermore, transcatheter leaflet cutting devices require extremely high precision in the fit between the cutting head and the leaflet, which directly affects the accuracy of clamping and cutting, especially when dealing with patients with complex anatomy. Existing delivery sheaths are mostly fixed-bend or have a limited adjustable angle (typically 0-180°), which is insufficient to handle special anatomical situations such as patients with transverse heart disease. In patients with transverse heart disease, the angle between the long axis of the heart and the longitudinal axis of the body is significantly increased, resulting in a more "horizontal" aortic root and valve annulus plane. In such cases, the limited adjustment angle makes it difficult to maintain good coaxiality and parallelism between the cutting head and the target leaflet, easily leading to incomplete cutting, leaflet tearing, or accidental damage to surrounding tissues, thus severely limiting the applicability of the device and the safety of the procedure.

[0030] Furthermore, existing flap cutting instruments typically consist of two or three independent sections as their control handles. This segmented design not only increases structural complexity and manufacturing costs, but also leads to poor control precision due to gaps in the connections and transmission between sections, affecting the surgeon's accurate manipulation of the distal actuators. For example, when multiple degrees of freedom such as bending, clamp opening and closing, and blade cutting need to be controlled simultaneously, segmented handles struggle to provide an integrated, efficient, and precise operating experience.

[0031] refer to Figures 1-5To address the aforementioned problems in the prior art, this invention provides a transcatheter valve leaflet cutting device, including a distal cutting section 100. The distal cutting section 100 is provided with a main body 110, a clamping arm 130, and a cutting blade 140. The clamping arm 130 is rotatably connected to the main body 110 to clamp and fix the valve leaflet tissue. The cutting blade 140 is used to electrically cut the fixed valve leaflet tissue when energized. Preferably, at least a portion of the cutting blade 140 is provided with a reinforcing layer 150 to enhance the surface structural strength of the cutting blade 140; at least a portion of the cutting blade 140 is provided with an anti-adhesion and heat-insulating layer 160 to achieve low-temperature cutting and prevent tissue adhesion; at least a portion of the cutting blade 140 is provided with an insulating layer 170 to isolate radio frequency current.

[0032] like Figure 2 In some embodiments, the main body 110 is configured as a dual-cavity structure, including a hollow inner cavity and a cutter guide groove that are isolated from each other, both extending axially along the main body 110. The hollow inner cavity has a distal opening and a proximal opening for guiding wires. The side of the cutter guide groove is open to accommodate the cutting blade 140 for axial movement. During movement, the cutting blade 140 is exposed in the open area of ​​the cutter guide groove to achieve electrical and / or physical cutting of the leaflets.

[0033] In some embodiments, the clamping arm 130 is connected to the main body 110 by a pivotal connection structure such as rivets to form a rotatable hinge point 131. A boss 132 is provided on the proximal side of the hinge point 131, and the boss 132 is slidably connected to a moving member 120. An inclined slot 121 is provided on the outer peripheral surface of the moving member 120, and the slot 121 matches the boss 132. The boss 132 can slide smoothly along the slot 121. The axial movement of the moving member 120 can drive the clamping arm 130 to rotate around the hinge point 131 to achieve opening and closing and to clamp the leaflet tissue.

[0034] like Figure 3 In some embodiments, the cutting blade 140 includes a blade body 141 and a control rod 142, wherein the control rod 142 is fixedly connected to the proximal end of the blade body 141 and is used to control the axial movement of the blade body 141; the blade body 141 is provided with a cutting edge 1411 for cutting the leaflet tissue, so as to cut the leaflet tissue during the movement.

[0035] In some embodiments, the control lever 142 is made of a conductive material, and at least the cutting edge 1411 of the cutter body 141 is also made of a conductive material. The control lever 142 is connected to and conducts electricity with the proximal end of the cutter body 141. When no power is applied, only the axial movement of the cutter body 141 can be controlled to achieve physical cutting of the leaflets. When power is applied, the cutting edge 1411 made of conductive material can achieve electrical cutting of the leaflets, which is especially suitable for calcified leaflets.

[0036] In some embodiments, the blade body 141 is generally flat or rod-shaped, with a blade 1411 disposed on its proximal and / or distal lateral edges; optionally, the blade 1411 is a single-sided or double-sided blade extending obliquely along the axial direction. The blade body 141 is made of conductive materials such as medical-grade stainless steel, titanium alloy, or cobalt-chromium alloy to ensure good conductivity, mechanical strength, and biocompatibility. In some embodiments, the control lever 142 is also made of conductive material, with its distal end fixedly connected to the proximal end of the blade body 141.

[0037] like Figure 4 , Figure 5 In some embodiments, the outer surface of the blade body 141 is provided with a functional coating structure. Preferably, a reinforcing layer 150 and an anti-sticking heat insulation layer 160 are sequentially or in combination disposed from the inside out in at least a portion or all of the blade 1411; and a reinforcing layer 150, an insulating layer 170 and an anti-sticking heat insulation layer 160 are sequentially or in combination disposed in at least a portion or all of the blade body 141 excluding the blade 1411.

[0038] Specifically, the reinforcing layer 150 can improve the surface hardness and wear resistance of the blade 1411 and the blade body 141 to cope with the mechanical stress during the cutting process; the insulating layer 170 can confine the radio frequency current to the blade 1411 area, reduce the diffusion loss of current to the side of the blade body 141 and the surrounding blood, thereby concentrating energy in the cutting area and improving cutting efficiency; the anti-adhesion heat insulation layer 160 can form a physical barrier during the cutting process, reduce the surface temperature of the blade and the heat transferred to the surrounding tissue, so as to achieve low-temperature cutting, while preventing protein denaturation and tissue adhesion caused by high temperature, ensuring the smoothness and safety of the cutting process.

[0039] In some embodiments, to prevent radio frequency current from leaking into surrounding tissues or blood via the surface of the control rod 142 during transmission and to reduce energy loss in the conduction path, at least a portion of the control rod 142 is provided with an insulating layer 170. Preferably, the insulating layer 170 completely covers the entire outer peripheral surface of the control rod 142, leaving only the exposed contact area required for the proximal end of the control rod 142 to connect to the power supply.

[0040] In some embodiments, the reinforcing layer 150 may be configured as a metal coating, a ceramic coating, or a diamond-like carbon (DLC) coating. The specific material may be selected from one of metallic chromium, titanium oxide, diamond-like carbon (DLC), or ceramic. Its thickness is preferably 0.1 μm-5 μm. It is used to enhance the surface hardness and wear resistance of the blade body 141 and the cutting edge 1411, thereby improving the service life of the cutting blade 140.

[0041] In some embodiments, the insulating layer 170 is configured as a medical polymer material with excellent electrical insulation properties and good biocompatibility, such as polytetrafluoroethylene (PTFE), and its thickness is configured to withstand a breakdown voltage of at least 2000V, preferably 5μm-20μm, to ensure electrical safety and energy isolation during radio frequency energy transmission, thereby concentrating energy in the blade 1411 region and improving cutting efficiency.

[0042] In some embodiments, the thickness of the anti-adhesion heat insulation layer 160 is 5μm-20μm, and it is made of a material with extremely low surface energy and excellent heat insulation performance, such as a fluoropolymer coating or a metal oxide coating. Specifically, the anti-adhesion heat insulation layer 160 can be selected as a zirconium oxide or special fluoropolymer (such as PFA, modified PTFE) coating. The coating of such materials can form a physical barrier during the cutting process, significantly reducing the surface temperature of the cutting head to 40°C-70°C, and preventing protein denaturation and tissue adhesion caused by high temperature.

[0043] Compared with the prior art, the embodiments of the present invention achieve synergistic optimization of technical effects by differentially setting functional coatings in different sections of the outer surface of the cutting blade 140. Specifically, a reinforcing layer 150 and an anti-sticking heat insulation layer 160 are sequentially set on the blade 1411, which not only enhances the mechanical strength and wear resistance of the blade 1411, but also significantly reduces the cutting temperature from 200-270℃ in traditional electric knives to 40-70℃ through low surface energy and heat insulation properties, effectively avoiding charring and carbonization of the leaflet tissue and thermal damage to adjacent healthy tissue; a reinforcing layer 150, an insulating layer 170, and an anti-sticking heat insulation layer 160 are sequentially set on the area of ​​the blade body 141 excluding the blade 1411, wherein the insulating layer 170... The radio frequency current can be effectively confined to the blade area 1411, significantly reducing the ineffective loss of current through the side of the blade and surrounding blood, thereby greatly improving energy utilization efficiency and cutting efficiency. At the same time, the anti-adhesion heat insulation layer 160 effectively prevents protein denaturation and tissue sintering and adhesion on the blade surface caused by high temperature, ensuring the smoothness and controllability of the cutting process. The insulating layer 170 set on the outer periphery of the control rod 142 effectively isolates the energy loss of radio frequency current in the transmission path and avoids accidental leakage of current to surrounding tissues and blood. Through the above-mentioned segmented coating structure, the embodiment of the present invention can achieve low-temperature, high-efficiency, and anti-adhesion precise cutting without changing the basic structure of existing electrosurgical units, significantly improving the safety and accuracy of leaflet removal surgery.

[0044] In some embodiments, the transcatheter valve cutting device further includes a catheter section 200, which is provided with an inner sheath 230, a middle sheath 220 and an outer sheath 210 from the inside to the outside; wherein, the distal end of the inner sheath 230 is connected to the main body 110 and is provided with a cavity for moving the guide wire and the control rod 142; the distal end of the middle sheath 220 is throttle-connected to the clamping arm 130 for controlling the opening and closing of the clamping arm 130; the distal end of the outer sheath 210 extends to the proximal end of the distal cutting section 100, and the outer sheath 210 is configured as an adjustable bending sheath that can be continuously controlled to bend by at least 270°.

[0045] like Figures 6-8 In some embodiments, the inner wall of the outer sheath 210 is provided with a flexible reinforcing metal layer and a traction wire 214. The reinforcing metal layer includes a first bending section 211, a second bending section 212 and a support section 213 from the distal end to the proximal end. The traction wire 214 is fixed to the distal end of the first bending section 211 and drives the bending of at least the first bending section 211 and the second bending section 212. The bending performance of the first bending section 211 is better than that of the second bending section 212, and the bending performance of the second bending section 212 is better than that of the support section 213.

[0046] In some embodiments, the reinforcing metal layer may preferably be a structure such as a hyaluronic acid tube, a helical spring, or a braided mesh tube.

[0047] When using a hysteresis tube, the first bending section 211 and the second bending section 212 are formed by laser cutting from the same hysteresis tube, and the cutting density of the first bending section 211 is significantly higher than that of the second bending section 212. That is, the first bending section 211 has more cutting grooves per unit length or the width of the cutting grooves is larger, which results in lower radial stiffness and higher bending flexibility.

[0048] When a helical spring is used, the first bending section 211 and the second bending section 212 have different pitches. The pitch of the first bending section 211 is greater than the pitch of the second bending section 212, which makes the bending stiffness of the former less than that of the latter.

[0049] When a braided mesh tube is used, the first bending section 211 and the second bending section 212 have different braiding densities. The braiding density of the first bending section 211 is less than that of the second bending section 212, which makes the bending stiffness of the former less than that of the latter.

[0050] Regardless of the structural form, the bending stiffness of the first bending section 211 is lower than that of the second bending section 212, and the bending stiffness of the second bending section 212 is lower than that of the support section 213. In addition, the axial length of the first bending section 211 is configured to be greater than that of the second bending section 212 to provide a longer flexible bending area at the distal end.

[0051] Specifically, when the traction wire 214 is pulled proximally, the tension first acts on the first bending segment 211, which has the lowest bending stiffness, causing it to bend significantly. As the tension increases, after the first bending segment 211 bends to a certain extent, the second bending segment 212 also begins to participate in the bending. Since the first bending segment 211 is longer and has lower bending stiffness, its bending curvature is greater, contributing the main bending angle. The second bending segment 212 provides supplementary bending, further superimposing the total bending angle. Through the smooth connection and coordination of the two bending segments, and the axial stability of the proximal tube body maintained by the support segment 213, the distal end of the entire outer sheath tube 210 can form a continuous and uniform large-arc bend, avoiding local bending or fish-mouth effect caused by stress concentration. Thus, a bending range of more than 270° can be achieved under controllable traction, enabling the distal cutting section 100 to adapt to large-angle deflections of the leaflets and delivery path in extreme anatomical structures such as transverse heart.

[0052] It should be noted that the support section 213 of the outer sheath 210 is not a completely rigid structure. To meet the delivery requirements of the transcatheter valve cutting device along the femoral artery approach through curved blood vessel paths such as the aortic arch, the support section 213 also has a certain degree of flexibility, allowing the outer sheath 210 to conform to the natural shape of the blood vessel and reduce the risk of stimulation and damage to the blood vessel wall. However, the bending function of this invention is mainly concentrated in the distal section of the outer sheath 210, that is, through the coordinated bending of the first bending section 211 and the second bending section 212, the direction and angle of the distal cutting part 100 in the target surgical area are adjusted to meet the precision requirements of valve clamping and cutting. The support section 213 is mainly used to provide axial pushing force, torque transmission capability and bending resistance support to ensure the smooth delivery and structural integrity of the outer sheath 210 in the blood vessel. Therefore, its bending performance is not the focus of this embodiment of the invention, and its bending angle or bending capability is not limited.

[0053] In some embodiments, the reinforcing metal layer is further provided with a bending transition section between the first bending section 211 and the second bending section 212. The cutting density, structural strength, and / or bending stiffness of the bending transition section are between those of the first bending section 211 and the second bending section 212. By providing the bending transition section, a smooth transition from the high flexibility of the first bending section 211 to the moderate flexibility of the second bending section 212 can be achieved, avoiding stress concentration or local bending caused by abrupt changes in stiffness between adjacent sections. This allows for a more uniform and continuous large-arc bend at the distal end of the outer sheath tube 210 during the pulling process of the traction wire 214, further improving the stability and controllability of the bending, and ensuring the stability and predictability of the shape of the outer sheath tube 210 when achieving ultra-large angle bending of 270° and above.

[0054] In some embodiments, at least one contrast-enhancing ring is provided in the distal wall of the outer sheath 210. The contrast-enhancing ring is used to observe the position and curvature of the distal end of the outer sheath 210 under surgical imaging, allowing the surgeon to assess the relative orientation and distance between the distal cutting portion 100 and the target leaflet in real time, thereby making corresponding adjustments and improving the accuracy and safety of the leaflet cutting surgery. In this embodiment, the specifications, dimensions, and specific materials of the contrast-enhancing ring are not specifically limited; those skilled in the art can choose any existing embodiment for adaptive settings.

[0055] like Figures 9-15In some embodiments, the transcatheter valve leaflet cutting device further comprises a proximal operation handle 300 connected to the proximal end of the catheter portion 200. The proximal operation handle 300 includes a bending control portion, an intermediate sheath locking portion and a cutting blade locking portion, wherein the bending control portion is configured to control the axial movement of the traction wire 214 to adjust the bending angle of the distal end of the outer sheath 210; the intermediate sheath locking portion is configured to selectively lock the axial movement of the intermediate sheath 220; the cutting blade locking portion is configured to lock the cutting blade 140 in the delivery state, and unlock the cutting blade 140 in the cutting state to enable the cutting blade 140 to move axially.

[0056] Specifically, the proximal operation handle 300 is entirely configured as an integrated structure, with a general shape of a "┓" form, comprising a distal main body 310 extending generally in the axial direction and a proximal main body 320 extending generally in the axial direction, as shown in Figure 9 . Further, the distal main body 310 is also in a "┓" form, the distal end of the distal main body 310 is fixedly connected to the proximal end of the outer sheath 210, and the proximal end thereof extends in the axial direction; the proximal main body 320 is rod-shaped, which is inserted into the interior of the proximal end of the distal main body 310 and can slide axially relative to the distal main body 310; the proximal main body 320 is fixedly connected to the proximal ends of the intermediate sheath 220 and the inner sheath 230, so as to transmit the operations of the intermediate sheath 220 and the inner sheath 230 to the distal cutting portion 100.

[0057] During the delivery phase of the device, the proximal main body 320 and the distal main body 310 are kept axially relatively locked by the intermediate sheath locking portion. At this time, the outer sheath 210, the intermediate sheath 220 and the inner sheath 230 are kept axially fixed relative to one another, and the distal cutting portion 100 is pushed to the target position as a whole along with the delivery system under the guidance of the guide wire. When the distal cutting portion 100 reaches the target working position, the operator operates the intermediate sheath locking portion to release the axial locking relationship between the proximal main body 320 and the distal main body 310, then the axial displacement and circumferential rotation of the intermediate sheath 220 can be realized, or the locking and unlocking of the cutter head can be controlled through the cutting blade locking portion. With the above integrated handle structure, there is no need to operate separate handle components during the operation, which simplifies the operation process and improves the control accuracy.

[0058] As shown in Figure 10In some embodiments, the bending control portion is disposed on the distal body 310 of the proximal operating handle 300 and extends outward at an angle relative to the central axis of the proximal operating handle 300, preferably at an angle of 20° to 45°, to facilitate operator operation and optimize the force distribution on the handle. The bending control portion includes a rotating operating member 311, a threaded moving member 312, and a traction wire fixing member 313. The rotating operating member 311 is rotatably disposed on the distal body 310, for example, through a bearing or shaft hole engagement to achieve circumferential rotation positioning; the threaded moving member 312 is threadedly engaged with the rotating operating member 311, and the outer periphery of the threaded moving member 312 is provided with an external thread that matches the internal thread of the rotating operating member 311; the traction wire fixing member 313 is disposed on the proximal side of the threaded moving member 312, and its distal end abuts against the proximal end of the threaded moving member 312.

[0059] In some embodiments, the proximal end of the traction wire 214 passes through the threaded moving member 312 and is fixed to the traction wire fixing member 313, for example, by welding, bonding, or mechanical clamping. When the rotating operating member 311 is rotated, the threaded moving member 312 is driven to move axially through the threaded engagement, thereby pushing or allowing the traction wire fixing member 313 to move synchronously, so as to achieve precise pulling or releasing of the traction wire 214.

[0060] In some embodiments, the traction wire fixing member 313 is configured to move proximally only under the push of the threaded moving member 312, and cannot actively pull the threaded moving member 312 distally. Specifically, when the rotating operating member 311 rotates in the first direction, the threaded moving member 312 moves proximally, and its proximally end face abuts against the distal end face of the traction wire fixing member 313, thereby pushing the traction wire fixing member 313 to move proximally synchronously to pull the traction wire 214 and cause the distal end of the outer sheath tube 210 to bend; when the rotating operating member 311 rotates in the second direction, the threaded moving member 312 moves distally, at which time the abutting thrust between the traction wire fixing member 313 and the threaded moving member 312 is lost, and the traction wire fixing member 313 passively moves distally under the action of its own elastic restoring force at the distal end of the outer sheath tube 210, so that the distal end of the outer sheath tube 210 gradually returns to its initial straight state. The aforementioned unidirectional pushing abutment design avoids problems such as kinking, tangling, or uneven force on the traction wire 214 due to passive pushing during the bending process, effectively reducing the risk of fatigue fracture of the traction wire 214 or failure of the bending mechanism, and improving the controllability and service life of the bending operation.

[0061] like Figures 10-12In some embodiments, the middle sheath locking part is disposed at the proximal end of the distal body 310 of the proximal operating handle 300, and is located approximately in the middle of the proximal operating handle 300, and is coaxially disposed with the central axis of the proximal operating handle 300; preferably, the middle sheath locking part includes a knob 314 and a clamping member 315; the knob 314 is rotatably disposed on the distal body 310 of the proximal operating handle 300, and the clamping member 315 is fixedly connected to the knob 314; the rotation of the knob 314 can drive the clamping member 315 to contract or expand radially.

[0062] In some embodiments, the middle sheath 220 passes through and is fixedly connected to the proximal body 320 of the proximal operating handle 300. Simultaneously, a tubular structure extending axially is fixedly connected to the distal end of the proximal body 320, defined as an axial extension tube 328, and the middle sheath 220 passes through the lumen of this axial extension tube 328. Therefore, the locking part of the middle sheath actually locks the axial extension tube 328, rather than directly acting on the middle sheath 220. Specifically, when the knob 314 drives the clamping member 315 to retract radially, the clamping member 315 grips the outer circumferential surface of the axial extension tube 328, thereby locking the relative position between the proximal body 320 and the distal body 310. In this state, the outer sheath 210 fixedly connected to the distal body 310, the middle sheath 220 fixedly connected to the proximal body 320, and the inner sheath 230 are all in a locked state of axial relative fixation. When the knob 314 drives the clamping member 315 to expand radially to release the axial extension tube 328, the locking relationship between the proximal body 320 and the distal body 310 is released. At this time, the operator can drive the middle sheath 220 and the inner sheath 230 to move axially or rotate circumferentially relative to the outer sheath 210 by axially pulling or circumferentially rotating the proximal body 320. This, in turn, drives the distal cutting part 100 to perform corresponding actions such as opening and closing of the clamping arm 130 and moving of the blade through the transmission relationship of the catheter part 200.

[0063] like Figure 11 , Figure 12 In some embodiments, the clamping member 315 is configured as a tubular structure with its outer peripheral surface being configured as a tapered surface that gradually tapers along the axial direction, and its sidewalls having a plurality of openings that extend along the axial direction and are evenly spaced along the circumference to provide radial deformation capability. Correspondingly, the inner wall of the distal body 310 of the proximal operating handle 300 has a tapered hole 316 that matches the outer peripheral surface of the clamping member 315.

[0064] After assembly, the clamping member 315 passes through the tapered hole 316, with its outer circumferential surface fitting against the inner circumferential surface of the tapered hole 316. The knob 314 engages with the clamping member 315 to drive the clamping member 315 to move axially within the tapered hole 316. When the knob 314 is rotated in the first direction, the clamping member 315 moves distally within the tapered hole 316. Due to the wedge-shaped fit between the tapered surfaces, the clamping member 315 is forced to contract radially, and its inner circumferential surface clamps against the outer circumferential surface of the axial extension tube 328, thereby achieving clamping and locking of the axial extension tube 328. When the knob 314 is rotated in the second direction, the clamping member 315 moves in the opposite direction, the fit clearance of the tapered surfaces increases, and the clamping member 315 expands radially under its own elastic restoring force, thereby releasing the axial extension tube 328. The clamping structure, which combines the conical surface with the opening, enables reliable locking and releasing with a simple rotational operation. The operation is intuitive and the clamping force is stable.

[0065] In some embodiments, the proximal body 320 of the proximal operating handle 300 is further provided with a middle sheath adjustment knob 321 and a middle sheath fixing member 322, both of which are also located approximately in the middle of the proximal operating handle 300; wherein, the middle sheath fixing member 322 is connected to the proximal end of the middle sheath 220; the middle sheath adjustment knob 321 is rotatably disposed on the proximal body 320 of the proximal operating handle 300 and is threadedly engaged with the middle sheath fixing member 322, and the rotation of the middle sheath adjustment knob 321 can drive the axial movement of the middle sheath fixing member 322, so as to drive the middle sheath 220 to move axially relative to the inner sheath 230.

[0066] In some embodiments, after the axial extension tube 328 is released by the middle sheath locking part, the operator can perform coarse adjustment of the middle sheath 220 and inner sheath 230 relative to the outer sheath 210 by axially pulling or circumferentially rotating the proximal body 320 of the proximal operating handle 300, so that the distal cutting part 100 is approximately positioned in the target working position. After the distal cutting part 100 is initially positioned, the operator re-locks the axial extension tube 328 by operating the middle sheath locking part, so that the proximal body 320 and the distal body 310 remain axially fixed.

[0067] Subsequently, the operator rotates the middle sheath adjustment knob 321, driving the middle sheath fixation member 322 to move proximally, thereby causing the middle sheath 220, which is fixedly connected to the middle sheath fixation member 322, to move proximally. The proximal movement of the middle sheath 220 is transmitted through the catheter section 200 to the distal moving member 120, causing the moving member 120 to move proximally relative to the main body 110; due to the sliding engagement between the moving member 120 and the clamping arm 130, the proximal movement of the moving member 120 causes the clamping arm 130 to rotate outward around the hinge point 131, thereby opening the clamping arm 130. After the clamp arm 130 is opened to the appropriate angle, the surgeon rotates the middle sheath adjustment knob 321 in the opposite direction, driving the middle sheath fixation component 322 to move distally, thereby driving the middle sheath 220 to move distally; the moving component 120 moves distally accordingly, and through sliding engagement, drives the clamp arm 130 to rotate inward around the hinge point 131, thereby closing the clamp arm 130 to clamp and fix the target leaflet tissue.

[0068] With the above structure, coarse positioning can be achieved by first sliding the proximal body 320 axially, and then fine control of the opening and closing of the clamping arm 130 can be achieved by rotating the middle sheath adjustment knob 321. This ensures that the distal cutting part 100 can quickly reach the target position, and also achieves precise and controllable adjustment of the leaflet clamping force, thereby improving the safety and accuracy of the surgical operation.

[0069] like Figures 13-15 In some embodiments, the cutting blade locking part includes a locking member 323, which is disposed inside the proximal end of the proximal body 320 of the proximal operating handle 300 and can move axially and rotate about the axis relative to the proximal body 320. The proximal end of the control rod 142 of the cutting blade 140 passes through a control rod fixing member 327, which is accommodated in the inner cavity of the locking member 323. The control rod fixing member 327 and the locking member 323 can rotate freely relative to each other in the circumferential direction (e.g., through clearance fit or bearing structure), while in the axial direction they are linked by a limiting structure such as an annular step or retaining ring provided in the inner cavity. This allows the axial movement of the locking member 323 to drive the control rod fixing member 327 and the control rod 142 to move synchronously, while the rotation of the locking member 323 will not be transmitted to the control rod 142 and the blade body 141, thereby avoiding unnecessary twisting of the blade in the blade guide groove and ensuring that the blade 1411 is always in the correct cutting orientation.

[0070] In some embodiments, the outer periphery of the locking member 323 is provided with at least one protrusion 3231, and the proximal body 320 of the proximal operating handle 300 is provided with a guide groove that cooperates with the protrusion 3231. The guide groove includes a first circumferential section 324, an axial section 325 and a second circumferential section 326 that are sequentially connected from the proximal end to the distal end. The protrusion 3231 can enter the guide groove from the first circumferential section 324, move to the distal end along the axial section 325 to the second circumferential section 326, and after circumferentially rotating within the second circumferential section 326, the locking member 323 is axially locked relative to the proximal operating handle 300.

[0071] In some embodiments, the first circumferential segment 324 and the second circumferential segment 326 are both arc-shaped grooves extending in the circumferential direction, and their corresponding central angles are preferably 60°; the protrusion 3231 can smoothly transition between the first circumferential segment 324 and the axial segment 325, and between the axial segment 325 and the second circumferential segment 326.

[0072] When the protrusion 3231 is located in the second circumferential section 326, the locking member 323 is restricted to this circumferential position. At this time, the cutter body 141 is positioned at the farthest end of the cutter guide groove for delivery and initial positioning via the duct leaflet cutting device. When the operator rotates the locking member 323 to move the protrusion 3231 from the second circumferential section 326 into the axial section 325 and moves it proximally along the axial section 325, the control rod fixing member 327 and the control rod 142 are driven to move proximally. The cutter body 141 then moves from the farthest end to the nearest end within the cutter guide groove, thereby achieving the cutting of the leaflet tissue. After the protrusion 3231 moves to the proximal end of the axial section 325, the operator rotates the locking member 323 again to move the protrusion 3231 into the first circumferential section 324. At this time, the cutter body 141 is positioned at the nearest end of the cutter guide groove.

[0073] Preferably, the length of the axial section 325 of the guide groove is configured to be equal to the movable distance of the cutter body 141 within the cutter guide groove. This ensures that when the protrusion 3231 moves from the second circumferential section 326 to the first circumferential section 324, the cutter body 141 can complete the entire stroke from the farthest end to the nearest end, achieving complete cutting of the leaflet tissue. Through the above-described guide groove design, the cutter head is allowed to move only in the axial section 325, while its locking position is achieved in the two circumferential sections. This ensures both safety during transport and precise control of the cutting stroke.

[0074] In some embodiments, the locking member 323 has two symmetrically arranged protrusions 3231 along its outer periphery. Correspondingly, the proximal body 320 of the proximal operating handle 300 has two symmetrically arranged guide grooves along its inner periphery that mate with the protrusions 3231. By adopting a symmetrical double protrusion 3231 and double guide groove mate structure, the locking member 323 can be subjected to more balanced forces during axial movement and circumferential rotation, avoiding skewness or jamming caused by unilateral force, thereby improving the smoothness of operation and the reliability of positioning of the locking member 323.

[0075] In summary, the transcatheter valve leaflet cutting device provided in this embodiment of the invention has the following significant advantages over the prior art: First, by differentially setting a multi-layer composite coating structure of reinforcing layer 150, insulating layer 170 and anti-adhesion heat insulation layer 160 in different sections of the outer surface of the cutting blade 140, the cutting temperature is greatly reduced, effectively avoiding thermal damage to the leaflet and surrounding healthy tissue. At the same time, it significantly inhibits the sintering and adhesion of tissue on the blade surface, improving the smoothness and controllability of cutting. Furthermore, the insulating layer 170 confines the radio frequency current to the blade 1411, greatly improving energy utilization efficiency and cutting efficiency.

[0076] Secondly, by setting multiple reinforcing metal layers with varying bending properties at the distal end of the outer sheath 210 and driving them with the traction wire 214, continuous and smooth large-angle bending of 270° and above is achieved, enabling the distal cutting part 100 to maintain good coaxiality and fit with the target leaflet, thereby significantly improving the adaptability to complex anatomical structures such as transverse heart.

[0077] Furthermore, by adopting an integrated proximal operating handle 300 and tilting the bending control part to the side, along with the structural design of the middle sheath locking part and the cutting blade locking part, the axial locking between the middle sheath tube 220, outer sheath tube 210 and inner sheath tube 230 is reliably locked during the operation. At the same time, it achieves precise control of multiple degrees of freedom for the opening and closing of the clamping arm 130, the movement of the cutting head and the bending of the outer sheath tube 210. This simplifies the operation process and avoids the problems of complex segmented handle structures and poor control precision.

[0078] Therefore, the transcatheter valve cutting device provided in this embodiment achieves comprehensive performance improvement in terms of low temperature, anti-adhesion, large-angle adjustable bending and high-precision control without changing the basic structure of the existing electrosurgical unit.

[0079] Furthermore, this embodiment of the invention also provides a transcatheter valve leaflet cutting system, including the transcatheter valve leaflet cutting device described in the above embodiments. The various technical features already included in the above embodiments are naturally inherited in this embodiment and will not be repeated.

[0080] In some embodiments, the transcatheter valve cutting system further includes an external power supply device for providing the high-frequency current required for electrical cutting to the transcatheter valve cutting device. This external power supply device has a power regulation function, allowing adjustment of 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 equipped with a display screen for real-time display of parameters such as output power and impedance, and has a standard interface for connecting to the transcatheter valve cutting device. In this embodiment, other specific structures, models, and specifications of the external power supply device are not specifically limited.

[0081] In addition, the transcatheter valve resection system can also be equipped with medical auxiliary equipment or instruments such as guide wires, catheters, and image-guided devices to assist in completing the surgical procedure. Specifically, the operation of the transcatheter valve resection device in this embodiment is the same as in the above embodiments, and will not be repeated here.

[0082] Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of this application. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of this application. All such changes and modifications are intended to be included within the scope of this application as claimed in the appended claims.

Claims

1. A transcatheter valve leaflet cutting device, characterized in that, The device includes a distal cutting section, which has a main body, a clamping arm, and a cutting blade. The clamping arm is rotatably connected to the main body to clamp and fix the leaflet tissue. The cutting blade is used to electrically cut the fixed leaflet tissue when energized. The cutting blade has a reinforcing layer in at least a portion of its section to enhance the surface structure strength of the cutting blade; the cutting blade has an anti-adhesion and heat insulation layer in at least a portion of its section to achieve low-temperature cutting and prevent tissue adhesion; and the cutting blade has an insulating layer in at least a portion of its section to isolate radio frequency current.

2. The transcatheter valve leaflet cutting device according to claim 1, characterized in that, The cutting blade includes a blade head body and a control lever connected thereto, and the blade head body is provided with a cutting edge; At least a portion of the blade is provided with the reinforcing layer and the anti-adhesion heat insulation layer, which are used to enhance the structural strength of the blade and achieve low-temperature cutting and prevent tissue adhesion; The cutter head body, excluding the cutting edge, has at least a portion of the section sequentially provided with the reinforcing layer, the insulating layer, and the anti-sticking heat insulation layer, which are used to enhance structural strength, isolate current, and achieve low-temperature cutting; At least a portion of the control lever is provided with the insulating layer to isolate the energy loss of radio frequency current during transmission.

3. The transcatheter valve leaflet cutting device according to claim 1, characterized in that, The reinforcing layer includes a metal coating, a ceramic coating, or a diamond-like carbon coating; the insulating layer includes a medical polymer coating; and the anti-sticking and heat-insulating layer includes a fluoropolymer coating or a metal oxide coating.

4. The transcatheter valve leaflet cutting device according to claim 3, characterized in that, The thickness of the reinforcing layer is 0.1μm-5μm; the thickness of the insulating layer is 5μm-20μm; and the thickness of the anti-sticking heat insulation layer is 5μm-20μm.

5. The transcatheter valve leaflet cutting device according to claim 2, characterized in that, It also includes a catheter section, which comprises, from the inside out: The inner sheath is connected to the main body at its distal end and is provided with cavities for guiding the guide wire and the control rod to move. The middle sheath is connected at its distal end to the clamping arm via a transmission mechanism, and is used to control the opening and closing of the clamping arm; The outer sheath extends distally to the proximal end of the distal cut portion, and the outer sheath is configured to be continuously controllable to bend by at least 270°.

6. The transcatheter valve leaflet cutting device according to claim 5, characterized in that, The outer sheath has a flexible reinforcing metal layer and a traction wire inside its tube wall. The reinforcing metal layer includes a first bending section, a second bending section and a support section from the distal end to the proximal end. The traction wire is fixed to the distal end of the first bending section and drives the bending of at least the first bending section and the second bending section. The bending performance of the first bending section is better than that of the second bending section, and the bending performance of the second bending section is better than that of the support section.

7. The transcatheter valve leaflet cutting device according to claim 6, characterized in that, The first bending section has a higher cutting density and / or lower structural strength and / or lower bending stiffness; and the axial length of the first bending section is greater than the axial length of the second bending section.

8. The transcatheter leaflet cutting device according to claim 7, characterized in that, The reinforcing metal layer is further provided with a bending transition section between the first bending section and the second bending section, and the cutting density, structural strength and / or bending stiffness of the bending transition section are between the first bending section and the second bending section.

9. The transcatheter valve leaflet cutting device according to claim 6, characterized in that, It also includes a proximal operating handle, which is connected to the proximal end of the catheter portion; the proximal operating handle includes: The bending control section is used to control the axial movement of the traction wire in order to adjust the bending angle of the distal end of the outer sheath. The middle sheath locking part is used to selectively lock the axial movement of the middle sheath; The cutting blade locking part is used to lock the cutting blade in the conveying state and unlock it in the cutting state to allow the cutting blade to move axially.

10. The transcatheter valve leaflet cutting device according to claim 9, characterized in that, The bending control part is disposed on the distal body of the proximal operating handle and extends outward at an angle relative to the central axis of the proximal operating handle; The bending control part includes a rotating operating component, a threaded moving component, and a traction wire fixing component; the distal end of the traction wire fixing component abuts against the proximal end of the threaded moving component, the threaded moving component is threadedly engaged with the rotating operating component, the rotating operating component is rotatably mounted on the distal body of the proximal operating handle, and the rotation of the rotating operating component can drive the threaded moving component and the traction wire fixing component to move axially, so as to pull the traction wire to achieve bending.

11. The transcatheter valve leaflet cutting device according to claim 9, characterized in that, The middle sheath locking part is located in the middle of the proximal operating handle and is coaxial with the central axis of the proximal operating handle; The locking part of the middle sheath includes a knob and a clamping member; the knob is rotatably disposed on the distal body of the proximal operating handle, and the clamping member is in transmission cooperation with the knob; the rotation of the knob can drive the clamping member to retract radially to limit the middle sheath axially and circumferentially, or to expand radially to release the middle sheath.

12. The transcatheter valve leaflet cutting device according to claim 9, characterized in that, The cutting blade locking part is located at the proximal end of the proximal operating handle and is coaxial with the central axis of the proximal operating handle; The cutting blade locking part includes a locking member, which is connected to the proximal end of the control lever, and the outer periphery of the locking member is provided with at least one protrusion. The proximal body of the proximal operating handle is provided with a guide groove that mates with the protrusion. The guide groove includes a first circumferential section, an axial section, and a second circumferential section that are connected sequentially from the proximal end to the distal end. The protrusion can enter the guide groove from the first circumferential section, move distally along the axial section to the second circumferential section, and after circumferential rotation within the second circumferential section, achieve axial locking of the locking member relative to the proximal operating handle.

13. The transcatheter leaflet cutting device according to claim 12, characterized in that, The locking member has two protrusions symmetrically arranged along its outer periphery, and the proximal body of the proximal operating handle has two guide grooves symmetrically arranged along its inner periphery.

14. A transcatheter valve leaflet cutting system, characterized in that, Includes the transcatheter leaflet cutting device as described in any one of claims 1-13.

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