Valve cutting device

Abstract

The application discloses a valve cutting device. The valve cutting device comprises a catching catheter and a cutting member. The catching catheter comprises a tube body, the tube body comprises a main body section and an adjustable bending section arranged at the distal end of the main body section. The adjustable bending section has a bending state, in which the adjustable bending section forms a hook structure. The cutting member is in a linear structure. The cutting member extends along the main body section, the distal end of the cutting member is arranged to pass through the tube wall at the distal end of the main body section and is fixedly connected with the distal end of the adjustable bending section. The part of the cutting member located outside the tube body is an active section, the active section moves synchronously with the adjustable bending section. The active section comprises a cutting part, the cutting part is located at the concave side of the adjustable bending section in the bending state. The valve cutting device of the application has the advantages that the cutting member is arranged on the catching catheter, only one catheter is needed to realize the catching and cutting of the valve leaf, the structure is simple, the surgical procedure is simplified, and the damage to the patient can be reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and more specifically, relates to a valve cutting device. Background Technology

[0002] Mitral regurgitation (MR) is a common valvular disease that can severely impact a patient's health and even be life-threatening. Common clinical treatments include mitral valve replacement or mitral valve repair. Edge-to-edge repair, a common mitral valve repair procedure, involves pulling the anterior and posterior leaflets of the mitral valve together and suturing them in place, or using valve clips or clamps via catheter intervention to connect the anterior and posterior leaflets, creating a two-hole structure to reduce or eliminate regurgitation and improve clinical condition.

[0003] Some patients may experience residual or recurrent regurgitation after a period of border-to-border repair, requiring further treatment to reduce the regurgitation. However, due to transvalvular pressure gradients or underlying mitral stenosis, adding another valve clip via intervention is not feasible; therefore, transcatheter mitral valve replacement (TMVR) is usually considered. The double-perforated structure formed by border-to-border repair hinders mitral valve replacement. Therefore, before secondary repair, the anterior and posterior leaflets of the mitral valve must be separated to form a large single-perforated structure for placement of an artificial mitral valve.

[0004] Existing technology discloses a cutting device for separating the valve clip from the leaflet, used to reshape the single-orifice structure of the mitral valve. The device includes a capture catheter, a transfer catheter, and a cutting component. During operation, the capture catheter and transfer catheter pass through the double-orifice structure of the mitral valve. The cutting component is delivered to the vicinity of the mitral valve via the transfer catheter. The distal end of the cutting component engages with the distal end of the capture catheter via a magnetic element. The capture catheter can then be pulled back to expose the cutting area of ​​the cutting component, thereby cutting the tissue surrounding the valve clip and separating the valve clip from the leaflet.

[0005] However, this cutting device uses multiple catheters, requiring a large-diameter sheath to establish a channel from outside the patient's body to allow multiple catheters to pass through simultaneously, which can cause significant damage to the patient. Furthermore, the capture catheter, delivery catheter, and cutting components need to be sequentially delivered to the vicinity of the mitral valve, making the surgical procedure complex, cumbersome, and time-consuming. Summary of the Invention

[0006] This invention aims to solve at least one of the technical problems existing in the prior art. To this end, this invention proposes a valve cutting device that requires only one catheter to capture and cut the valve leaflets. Its simple structure simplifies the surgical procedure, and its ease of operation can significantly shorten the operation time.

[0007] The valve cutting device according to an embodiment of the present invention includes a grasping catheter and a cutting component. The grasping catheter includes a tube body, which includes a main section and an adjustable bend section located at the distal end of the main section. The adjustable bend section has a bent state, and in the bent state, the adjustable bend section forms a hook-like structure. The cutting component has a linear structure. The cutting component extends along the main section, and its distal end protrudes from the tube wall at the distal end of the main section and is fixedly connected to the distal end of the adjustable bend section. The portion of the cutting component located outside the tube body is a movable section, which moves synchronously with the adjustable bend section. The movable section includes a cutting portion located on the concave side of the adjustable bend section in the bent state.

[0008] The valve cutting device of this invention combines a grasping catheter and a cutting component, integrating both grasping and cutting functions. It can separate two leaflets of a heart valve that are joined edge-to-edge during repair, thereby restoring the natural single-pore structure of the valve and facilitating repair or replacement therapy. Because the cutting component is located on the grasping catheter, only one catheter is needed for both leaflet grasping and cutting, simplifying the structure and surgical procedure, and significantly reducing operation time. Furthermore, by using a single catheter, a smaller diameter sheath can be used to establish the surgical channel from outside the patient's body, minimizing trauma to the patient.

[0009] In some embodiments, the main body section has a receiving channel along the axial direction in the pipe wall, and the cutting component part passes through the receiving channel.

[0010] In some embodiments, the capture catheter also includes a traction wire. The tube wall is provided with a traction channel along the axial direction, which runs through the main body section and the adjustable bend section. The traction wire is movably inserted in the traction channel. The distal end of the traction wire is connected to the adjustable bend section. The traction wire moves in the traction channel to make the adjustable bend section bend or straighten.

[0011] In some embodiments, the tube body includes an outer tube and an inner tube fixedly disposed within the outer tube. The inner tube is a flexible tube, the outer tube has a higher hardness than the inner tube, the outer tube has a lower hardness at the adjustable bend section than at the main body section, and a first gap is formed axially between the inner and outer tubes. A receiving channel and a traction channel are disposed within the first gap.

[0012] In some embodiments, the tube body further includes a reinforcing tube disposed between the inner tube and the outer tube, which divides the first gap into a second gap and a third gap from the inside out. The receiving channel and the traction channel are both located in the second gap or the third gap, or the receiving channel and the traction channel are located in different gaps within the second and third gaps.

[0013] In some embodiments, on a cross section of the tube perpendicular to its central axis, the traction channel and the receiving channel are located in a 30° sector region centered on the central axis.

[0014] In some embodiments, the capture catheter includes two traction wires, and the tube wall has two traction channels symmetrically arranged about the central axis of the tube, with a receiving channel located between the two traction channels.

[0015] In some embodiments, the capture guide tube further includes a tapered guide head located at the distal end of the adjustable bend section. The proximal end of the movable section is fixedly or movably connected to the distal end of the main body section, and the distal end of the movable section is fixedly connected to the guide head. In some embodiments, the adjustable bend section also has a straight state, in which the movable section is substantially straight and closely adheres to the adjustable bend section.

[0016] In some embodiments, the axial length of the adjustable bend is in the range of 1cm-5cm, and the cutting part is located in the middle region along the axial direction of the adjustable bend, with an axial length range of 0.5mm-10mm.

[0017] In some embodiments, the cutting member includes a conductive core and an insulating layer encasing the conductive core, with the insulating layer on the side of the cutting section opposite to the adjustable bend being peeled off to expose the conductive core. The valve cutting device also includes an energy generator electrically connected to the proximal end of the conductive core.

[0018] In some embodiments, the cutting part is a blade located on the side of the movable section opposite to the adjustable curved section.

[0019] In some embodiments, the valve cutting device further includes a retaining ring, which is fitted over the capture catheter, and the adjustable bend and the movable section are inserted through the retaining ring.

[0020] In some embodiments, the valve cutting device further includes an operating handle, which is fixedly connected to the proximal end of the tube body and is used to operate the adjustable bend in a bent state.

[0021] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0022] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0023] Figure 1 This is a perspective view of the adjustable bending section of the valve cutting device according to an embodiment of the present invention in a straight state.

[0024] Figure 2 yes Figure 1 Enlarged view of point A in the middle;

[0025] Figure 3This is a perspective view of the adjustable bending section of the valve cutting device according to an embodiment of the present invention in a bent state;

[0026] Figure 4 yes Figure 3 Enlarged view of point C in the middle;

[0027] Figure 5 This is a schematic diagram of the anatomical structure of the mitral valve after the implantation of a valve clip;

[0028] Figure 6 This is a schematic diagram of the process by which two leaflets of a heart valve, which have been repaired and connected edge-to-edge, are separated into a single orifice by the valve cutting device of this invention.

[0029] Figure 7 This is a schematic cross-sectional view of the tube body of a valve cutting device according to some embodiments of the present invention;

[0030] Figure 8 This is a schematic cross-sectional view of the tube body of a valve cutting device according to other embodiments of the present invention;

[0031] Figure 9 This is a schematic cross-sectional view of the tube body of a valve cutting device according to some other embodiments of the present invention;

[0032] Figure 10 This is a schematic cross-sectional view of the tube body of a valve cutting device according to some other embodiments of the present invention;

[0033] Figure 11 This is a perspective view of the connection between the anchoring ring and the traction wire of the valve cutting device according to an embodiment of the present invention;

[0034] Figure 12 yes Figure 1 Enlarged view of point B in the middle;

[0035] Figure 13 This is a schematic diagram of the cutting component of a valve cutting device according to some embodiments of the present invention;

[0036] Figure 14 This is a schematic diagram of the cutting component of a valve cutting device according to other embodiments of the present invention;

[0037] Figure 15 This is a perspective view of the adjustable bending section of a valve cutting device according to another embodiment of the present invention in a bent state.

[0038] Figures 16-18 This is a schematic diagram of the process of removing the valve clip from the mitral valve leaflet using a valve cutting device via the femoral vein approach;

[0039] Figure 19This is a schematic diagram of the process of removing the valve clips from the mitral valve leaflets via the apical approach using a valve cutting device.

[0040] Figure 20 This is a schematic diagram of the process of removing the valve clip from the tricuspid valve leaflet using a valve cutting device via the femoral vein approach. Detailed Implementation

[0041] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0042] The terms "proximal" and "distal" used in this invention specification are commonly used in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator during the surgical procedure, while "proximal" refers to the end closest to the operator during the surgical procedure. The direction of the axis of rotation of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object; and the radial direction is the direction along the diameter or radius. It is worth noting that the term "end" appearing in terms such as "proximal," "distal," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, end point, or end face, but also includes a portion extending axially and / or radially from the tip, end point, or end face on the element to which the tip, end point, or end face belongs.

[0043] Please see Figures 1-4 The valve cutting device 1 of this invention includes a grasping catheter 10 and a cutting member 20. Specifically, the grasping catheter 10 includes a tube body 11, which includes a main body segment 12 and an adjustable bend segment 13 located at the distal end of the main body segment 12. The adjustable bend segment 13 has a bent state, and in the bent state, the adjustable bend segment 13 forms a hook-shaped structure. The cutting member 20 has a linear structure and extends along the main body segment 12. The distal end of the cutting member 20 passes through the tube wall at the distal end of the main body segment 12 and is fixedly connected to the distal end of the adjustable bend segment 13. The portion of the cutting member 20 located outside the tube body 11 is a movable segment 21. The movable segment 21 moves synchronously with the adjustable bend segment 13. The movable segment 21 includes a cutting part 212, which is located on the concave side of the adjustable bend segment 13 in the bent state.

[0044] The valve cutting device 1 of this invention combines a grasping catheter 10 with a cutting component 20, integrating both grasping and cutting functions. It can separate two leaflets of a heart valve that are edge-to-edge repaired together, thereby restoring the natural single-pore structure of the valve and facilitating repair or replacement therapy. Since the cutting component 20 is mounted on the grasping catheter 10, only one catheter is needed for both leaflet grasping and cutting, simplifying the structure and surgical procedure, and significantly reducing operation time. Furthermore, by using a single catheter, a smaller diameter sheath can be used to establish the surgical channel from outside the patient's body, minimizing trauma to the patient.

[0045] It is understood that the adjustable bend 13 has a straight state and a curved state, and the adjustable bend 13 can switch between the two states. The straight state refers to the central axis of the adjustable bend 13 being a straight line, while the curved state refers to the central axis of the adjustable bend 13 being an arc. Within the adjustment angle range of the adjustable bend 13, the adjustable bend 13 can be bent to any angle according to the cardiac anatomy, forming a hook-like structure that facilitates the capture and support of the valve leaflets. Since the movable segment of the cutting component 20 moves synchronously with the adjustable bend 13, the movable segment 21 bends synchronously with the adjustable bend 13 from straight to curved, or straightens synchronously with the adjustable bend 13 from curved to straight. In the straight state, the movable segment 21 is basically straight and closely adheres to the adjustable bend 13. This reduces the radial width of the valve cutting device 1 during delivery. In addition, since the cutting component 20 is attached to the tube body 11 of the capture conduit 10, it will also move as the capture conduit 10 moves.

[0046] When using the valve cutting device 1, the adjustable bend 13, which is bent into a hook shape, provides support for the cutting part 212, so that the cutting part 212, which is located on the concave side of the adjustable bend 13 in the bent state, contacts the leaflet to cut, thereby separating the two leaflets that are repaired and connected at the edge-to-edge and restoring the single-pore structure of the natural valve.

[0047] It should be noted that the linear structure of the cutting component 20 refers to the cutting component 20 being a slender piece with a certain axial length. The cutting method of the cutting part 212 can be selected from mechanical cutting, electrosurgical cutting, laser cutting, electromagnetic cutting, microwave cutting, ultrasonic cutting, or semiconductor thermal coagulation cutting, etc. Depending on the different cutting methods, the proximal end of the cutting component 20 can be connected to different energy generators, so that the cutting part 212 can cut leaflets. The cutting component 20 can extend in the lumen of the main body segment 12 or in the wall of the main body segment 12, so that the distal end of the cutting component 20 protrudes from the wall of the distal end of the main body segment 12. The distal end of the main body segment 12 is not limited to the distal end head or distal end face, but also includes a portion extending a certain axial distance from the distal end head or distal end face to the proximal end, which can be selected, for example, 5 cm.

[0048] In some embodiments, the adjustable bending section 13 has a bending angle range of 0° to 270°, meaning that the adjustable bending section 13 is at 0° when it is straight, and can be bent from 0° to the maximum angle of 270°.

[0049] Please see Figure 5 and Figure 6 In some embodiments, the valve cutting device 1 is mainly used to cut the leaflets of the mitral valve (MV) or tricuspid valve (TV) with edge-to-edge repair, separating the two leaflets that are fixed by sutures, or separating the two leaflets that are clamped together by valve clips 2 or clamping needles, changing the two-hole structure to a single-hole structure. In other embodiments, the valve cutting device 1 can also be used to cut the adhesions at the leaflet junction of the valve to treat valvular stenosis, such as aortic stenosis and mitral stenosis.

[0050] Please see Figures 7-10 In some embodiments, the capture catheter 10 further includes a traction wire 14. The tube wall of the tube body 11 has an axially oriented traction channel 102 that passes through the main body section 12 and the adjustable bend section 13. The traction wire 14 is movably inserted into the traction channel 102, and its distal end is connected to the adjustable bend section 13. The traction wire 14 moves within the traction channel 102 to bend or straighten the adjustable bend section 13. Thus, by pulling or releasing the traction wire 14, the adjustable bend section 13 can be completely straightened or restored to its original straightness, making the operation simple.

[0051] While maintaining sufficient strength to achieve the traction function, the radial cross-section of the traction wire 14 should be as small as possible. Therefore, the diameter of the traction wire 14 is preferably in the range of 0.05 mm to 0.25 mm. The traction wire 14 can be made of metallic materials, such as stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy, or it can be made of polymer materials with a certain strength. No specific material limitation is made here. The traction wire 14 is preferably made of stainless steel wire with a diameter of 0.25 mm.

[0052] In some embodiments, the capture catheter 10 includes two traction wires 14. Correspondingly, the tube wall of the tube body 11 is provided with two traction channels 102 along the axial direction, and each traction wire 14 is located in the corresponding traction channel 102. In other embodiments, the tube wall of the tube body 11 is provided with one traction channel 102 along the axial direction, and the two traction wires 14 can share one traction channel 102. Of course, one traction wire 14 can also be used to pull the adjustable bend 13 to bend it, or the adjustable bend 13 can be restored to straightness after the traction force on the traction wire 14 is released.

[0053] Please see Figure 11In some embodiments, the capture guide 10 further includes an anchoring ring 142 disposed at the distal end of the traction wire 14, the distal end of the traction wire 14 being connected to the adjustable bend 13 via the anchoring ring 142. Preferably, the anchoring ring 142 and the adjustable bend 13 are coaxial, and the anchoring ring 142 can be thermally fused to the adjustable bend 13. In some embodiments, the distal ends of the two traction wires 14 are respectively fixedly connected to the anchoring ring 142, and the anchoring ring 142 is fixedly sleeved on the adjustable bend 13. The anchoring ring 142 can increase the contact area between the traction wire 14 and the adjustable bend 13, thereby enabling better traction of the bend of the adjustable bend 13. The anchoring ring 142 can be made of metal or polymer material; in some embodiments, the anchoring ring 142 is made of metal such as SUS304 stainless steel. The methods of fixing the traction wire 14 and the anchoring ring 142 include, but are not limited to, bonding, welding, thermal fusion, knotting, etc.

[0054] Besides using the traction wire 14 to pull the adjustable bending section 13 for bending, in other embodiments, the adjustable bending section 13 can also be bent by electric heating. Specifically, the adjustable bending section 13 is made of a heat-deformable material, and heating the adjustable bending section 13 with electricity can change the adjustable bending section 13 from a straight state to a bent state. It can be understood that when no electricity is applied, the adjustable bending section 13 is in a straight state. The degree of bending of the adjustable bending section 13 is related to the temperature reached by heating; the higher the temperature, the greater the degree of bending. After the power is turned off and heating is stopped, the adjustable bending section 13 can return to a straight state.

[0055] Please see Figures 7-10 and Figure 12 In some embodiments, the main body section 12 has an axially oriented receiving channel 104 in its pipe wall, and the cutting member 20 partially passes through the receiving channel 104. This prevents the cutting member 20 from being interfered with by other structures in the main body section 12 pipe wall. It is understood that the cutting member 20 can be fixedly connected to the receiving channel 104 or movably connected. The movable section 21 extends from the distal end of the receiving channel 104 and is located outside the pipe body 11; the distal end of the movable section 21 is fixedly connected to the distal end of the adjustable bend section 13. When the cutting member 20 is fixedly connected to the receiving channel 104, the length of the movable section 21 ensures that it fits snugly against the adjustable bend section 13 without redundancy. When the cutting member 13 is movably connected to the receiving channel 104, the cutting member 20 can be pulled to tighten its movable section 21, facilitating the cutting of the leaflets.

[0056] Please see Figure 7In some embodiments, the pipe body 11 includes an outer pipe 112 and an inner pipe 114 fixedly disposed within the outer pipe 112. The inner pipe 114 is a flexible pipe, and the hardness of the outer pipe 112 is greater than that of the inner pipe 114. The hardness of the outer pipe 112 at the adjustable bend section 13 is less than that at the main body section 12. A first gap 110 is formed axially between the inner pipe 114 and the outer pipe 112. A receiving channel 104 and a traction channel 102 are disposed within the first gap 110. Thus, the pipe body 11 includes a double-layered pipe, with the receiving channel 104 and the traction channel 102 disposed between the outer pipe 112 and the inner pipe 114, facilitating the embedding of the receiving channel 104 and the traction channel 102 within the pipe wall of the pipe body 11.

[0057] It is understandable that the inner tube 114 is a flexible tube, making it easy to bend. The outer tube 112 has a higher hardness than the inner tube 114, providing support and protection for the tube body 11. The hardness of the outer tube 112 at the adjustable bend section 13 is lower than that at the main body section 12, ensuring that the hardness of the outer tube 112 protects the tube body 11 without affecting the bending of the adjustable bend section 13. It should be noted that the inner tube 114 can be made of flexible materials such as polytetrafluoroethylene (PTFE), while the outer tube 112 can be made of materials with a certain degree of hardness, such as polyether block polyamide (PEBAX). In some embodiments, the inner tube 114 and the outer tube 112 can be thermoformed together to form at least one lumen that extends completely from the proximal end to the distal end.

[0058] Further, please refer to Figures 8-10 The tube body 11 also includes a reinforcing tube 116, which is disposed between the inner tube 114 and the outer tube 112. The reinforcing tube 116 divides the first gap 110 from the inside to the outside into a second gap 1102 and a second gap 1104. For example, Figure 8 and Figure 9 As shown, both the receiving channel 104 and the traction channel 102 are located in the second gap 1102 or the second gap 1104; or as... Figure 10 As shown, the receiving channel 104 and the traction channel 102 are located in different gaps within the second gap 1102 and the second gap 1104. This allows for configuration according to actual needs, increasing the diversity of structural designs.

[0059] It is understood that a PI tube or a PTFE tube can be embedded in the second gap 1102 between the inner tube 114 and the reinforcing tube 116, or in the second gap 1104 between the reinforcing tube 116 and the outer tube 112, to form a traction channel 102; alternatively, a PI tube or a PTFE tube can be embedded in the second gap 1102 between the inner tube 114 and the reinforcing tube 116, or in the second gap 1104 between the reinforcing tube 116 and the outer tube 112, to form a receiving channel 104. Preferably, both the traction channel 102 and the receiving channel 104 are located within the second gap 1102.

[0060] The reinforcing tube 116 has a certain rigidity and can be bent in the axial direction, thereby providing support for the tube body 11 and preventing the tube body 11 from tortuously deforming in the radial direction, while not affecting the bending of the adjustable bending section 13. In some embodiments, the reinforcing tube 116 is a metal braided mesh structure woven from materials such as stainless steel wire, tungsten wire, or nickel-titanium wire. The inner tube 114, the reinforcing tube 116, and the outer tube 112 can be hot-melt composite molded together.

[0061] Please see Figures 7-10 In some embodiments, on a cross section of the tube 11 perpendicular to its central axis, the traction channel 102 and the receiving channel 104 are located in a 30° sector region centered on the central axis. This ensures that when the adjustable bending section 13 is bent by the traction wire 14, the cutting portion 212 bends with the adjustable bending section 13, and the cutting portion 212 on the movable section 21 can cut the leaflets.

[0062] In some embodiments, the capture conduit 10 includes two traction wires 14, and the tube wall of the tube body 11 is provided with two traction channels 102 symmetrically arranged about the central axis of the tube body 11 along the axial direction. The receiving channel 104 is located between the two traction channels 102. In this way, the cutting member 20 is located in the middle of the two traction wires 14, and after bending, it can fully contact the leaflets to ensure the cutting effect.

[0063] Please see Figure 2 In some embodiments, the capture catheter 10 further includes a tapered guide head 15, which is located at the distal end of the adjustable bend section 13. The proximal end of the movable section 21 is fixedly or movably connected to the distal end of the main body section 12, and the distal end of the movable section 21 is fixedly connected to the guide head 15. Thus, the tapered guide head 15 facilitates the insertion of the capture catheter 10 into the lumen of a blood vessel or tissue.

[0064] It is understood that the proximal end of the movable segment 21 is fixedly connected to the distal end of the main body segment 12, so even if the cutting component 20 is pulled towards the proximal end, the movable segment 21 will not enter the main body segment 12; conversely, the proximal end of the movable segment 21 is movably connected to the distal end of the main body segment 12, meaning that if the cutting component 20 is pulled towards the proximal end, the movable segment 21 can partially enter the main body segment 12. The distal end of the movable segment 21 can be straight and fixed to the guide head 15 by wrapping, ensuring a stable connection. The distal end of the movable segment 21 can also be a spiral structure, fixedly sleeved on the guide head 15. Of course, the spiral structure at the distal end of the movable segment 21 can also be sleeved and fixed between the outer tube 112 and the reinforcing tube 116.

[0065] In some embodiments, a radiopaque imaging ring, such as a tantalum ring, is provided near the proximal end of the guide head 15, which allows for accurate determination of whether the distal end of the capture conduit 10 has reached the designated position under imaging equipment.

[0066] In some embodiments, the axial length of the adjustable bending segment 13 ranges from 1cm to 5cm, and the cutting portion 212 is located in the middle region along the axial direction of the adjustable bending segment 13, with an axial length ranging from 0.5mm to 10mm. This ensures that the curvature of the adjustable bending segment 13 in its bent state can grasp tissue while also ensuring that the length of the cutting portion 212 can cut the tissue. Preferably, the axial length of the adjustable bending segment 13 is 3cm, and the length of the cutting portion 212 is 2mm. It should be noted that when the adjustable bending segment 13 is in a straight state, the length of the movable segment 21 is approximately equal to the axial length of the adjustable bending segment 13, to avoid the length of the movable segment 21 affecting the bending of the adjustable bending segment 13.

[0067] Please see Figure 13 and Figure 14 In some embodiments, the cutting member 20 includes a conductive core 214 and an insulating layer 216 encasing the conductive core 214. The insulating layer 216 on the side of the cutting portion 212 facing away from the adjustable bend 13 is peeled off to expose the conductive core 214. The valve cutting device 1 also includes an energy generator electrically connected to the proximal end of the conductive core 214 of the cutting member 20. Thus, the conductive core 214 is exposed on the side of the cutting portion 212 facing away from the adjustable bend 13, allowing the conductive core 214 to contact the leaflet to energize and cut the leaflet. In addition, the insulating layer 216 on the side of the cutting portion 212 facing the adjustable bend 13 is retained, which can both avoid current dispersion to ensure the cutting effect and prevent the current from heating and melting the adjustable bend 13.

[0068] The cutting section 212 employs an electrosurgical cutting method, preferably a radio frequency (RF) electrosurgical cutting method. The energy generator is an RF generator, which is electrically connected to the conductive core 214. During the cutting process, a high-frequency current is transmitted through the conductive core 214, causing the charged positive and negative ions in the leaflets surrounding the cutting section 212 to oscillate at high speed. The high-speed oscillating ions generate a large amount of heat due to friction, raising the temperature inside the leaflets. Ultimately, this leads to protein denaturation within the cells, loss of water both inside and outside the cells, and coagulative necrosis of the leaflets, thus achieving RF cutting. The RF generator operates in the frequency range of 1500 kHz to 4500 kHz, exhibiting a strong skin effect that avoids burns and other accidents, minimizing thermal damage to the leaflets. It is understood that when using other methods such as electrosurgical cutting, laser cutting, electromagnetic cutting, microwave cutting, ultrasonic cutting, or semiconductor thermal coagulation cutting, the corresponding energy generator should be electrically connected to the proximal end of the conductive core 214.

[0069] In some embodiments, the cutting part 212 is a blade located on the side of the movable section 21 opposite to the adjustable curved section 13. Thus, the cutting part 212 has a blade on the side opposite to the adjustable curved section 13, so that the blade contacts the leaflet to cut the leaflet by mechanical cutting.

[0070] Please see Figure 15 In some embodiments, the valve cutting device 1 further includes a fixing ring 30, which is sleeved on the outside of the capture catheter 10, with the adjustable bend section 13 and the movable section 21 passing through the fixing ring 30. Thus, the fixing ring 30 ensures that the movable section 21 is tightly fitted against the adjustable bend section 13, guaranteeing the cutting effect of the cutting section 212. In some embodiments, the fixing ring 30 is made of insulating material and is fixedly sleeved on the adjustable bend section 13, with the fixing ring 30 in contact with the non-cutting portion of the movable section 21. Alternatively, the fixing ring 30 can be movably sleeved on the adjustable bend section 13, with a clearance fit between the fixing ring 30, the adjustable bend section 13, and the movable section 21, preventing the fixing ring 30 from slipping off the adjustable bend section 13.

[0071] Please see Figure 1 and Figure 3 In some embodiments, the valve cutting device 1 further includes an operating handle 40, which is fixedly connected to the proximal end of the tube body 11. The operating handle 40 is used to operate the adjustable bend section 13 into a bent state. In this way, the adjustable bend section 13 can be easily adjusted by operating the operating handle 40.

[0072] It is understood that when the adjustable bending section 13 is bent using the traction wire 14, the operating handle 40 is equipped with a bending adjustment knob, and the proximal end of the traction wire 14 is connected to the bending adjustment knob. Thus, the adjustable bending section 13 can be bent or straightened by operating the bending adjustment knob using the traction wire 14. When the adjustable bending section 13 is bent using electric heating, the operating handle 40 is equipped with an electric heating switch, which is electrically connected to the adjustable bending section 13 via a wire.

[0073] Please see Figures 16-18 The following describes the process by which the valve cutting device 1 removes the valve clip 2 from the leaflet of the mitral valve MV via the femoral vein approach.

[0074] First, the valve cutting device 1 enters the left atrium LA above the mitral valve MV through the guide sheath, aligns with one of the valve orifices E, and pushes the valve cutting device 1 through the valve orifice E into the left ventricle LV to the appropriate distance.

[0075] Then, by operating the handle 40, the capture catheter 10 is adjusted to a suitable angle so that the distal end of the capture catheter 10 is aligned with the valve orifice F on the other side. The valve cutting device 1 is pulled back so that it hooks the valve leaflet, so that the conductive core 214 of the cutting part 212 contacts the tissue around the valve clip 2.

[0076] Next, the leaflets are cut using an electrosurgical radiofrequency ablation until valve clip 2 separates from the anterior leaflet AML or the posterior leaflet PML, reforming a large single-hole structure that allows the patient to undergo interventional valve replacement therapy. Typically, cutting the anterior leaflet AML is preferred, allowing valve clip 2 to separate from it and attach to the posterior leaflet PML, thus avoiding obstruction of the aortic outflow tract.

[0077] Now refer to Figure 19 After the valve cutting device 1 enters the left ventricle (LV) through the apical puncture sheath, the capture catheter 10 enters the left atrium (LA) through one valve orifice (E). After the capture catheter 10 is bent by the operating handle 40, the distal end of the capture catheter 10 is aligned with the other valve orifice (F). The valve cutting device 1 is pulled back so that the conductive core 214 of the cutting part 212 contacts the tissue around the valve clip 2 to cut the valve leaflet.

[0078] Reference Figure 20 The procedure describes the removal of the valve clip 2 between the anterior leaflet ATL and the septal leaflet of the tricuspid valve TV. The valve cutting device 1 enters the right atrium through a guide sheath, and the grabbing catheter 10 enters through the valve orifice X. After being bent and aligned with the valve orifice Y, it is pulled back to hook the leaflet, so that the conductive core 214 of the cutting part 212 contacts the tissue around the valve clip 2 to cut the leaflet.

[0079] In the description of this invention, it should be understood that the terms "upper," "lower," "left," "right," "inner," "outer," "axial," "radial," and "circumferential," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, features defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0080] 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. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0081] In the description of this specification, the references to terms such as "certain embodiments," "some embodiments," "illustrative embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0082] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A valve cutting device, characterized in that, The snaring catheter comprises a tube body, the tube body comprises a main body section and an adjustable bending section arranged at the distal end of the main body section, the adjustable bending section has a bending state, in the bending state, the adjustable bending section forms a hook structure. And A cutting member in a linear structure, the cutting member extends along the main body section, the distal end of the cutting member is out of the tube wall at the distal end of the main body section and is fixedly connected with the distal end of the adjustable bending section, the part of the cutting member outside the tube body is a movable section, the movable section moves synchronously with the adjustable bending section, the movable section comprises a cutting part, the cutting part is located on the concave side of the adjustable bending section in the bending state. When the snaring catheter is bent, the distal end of the snaring catheter can be bent from one side of the mitral valve or tricuspid valve to align with the other side of the valve orifice, the hook structure formed by the adjustable bending section can hook the valve leaflet, and the cutting part can contact and cut the valve leaflet. The tube wall of the main body section is provided with a receiving channel in the axial direction, and the cutting member is partially arranged in the receiving channel.

2. The valve cutting device of claim 1, wherein, The snaring catheter further comprises a traction wire, the tube wall of the tube body is provided with a traction channel penetrating through the main body section and the adjustable bending section in the axial direction, the traction wire is movably arranged in the traction channel, the distal end of the traction wire is connected with the adjustable bending section, and the traction wire moves in the traction channel to make the adjustable bending section bend or recover to be flat.

3. The valve cutting device of claim 2, wherein, The tube body comprises an outer tube and an inner tube fixedly arranged in the outer tube, the inner tube is a flexible tube, the hardness of the outer tube is greater than that of the inner tube, the hardness of the outer tube at the adjustable bending section is less than that of the outer tube at the main body section, and a first gap is formed between the inner tube and the outer tube in the axial direction.

4. The valve cutting device of claim 3, wherein, The receiving channel and the traction channel are arranged in the first gap. The tube body further comprises a reinforcing tube, the reinforcing tube is arranged between the inner tube and the outer tube, and the reinforcing tube divides the first gap into a second gap and a third gap from inside to outside.

5. The valve cutting device of claim 4, wherein, The receiving channel and the traction channel are arranged in the second gap or the third gap, or the receiving channel and the traction channel are arranged in different gaps of the second gap and the third gap. In the cross section of the tube body perpendicular to the central axis thereof, the traction channel and the receiving channel are arranged in a 30° sector region with the central axis as the center.

6. The valve cutting device of any of claims 3-5, wherein, The snaring catheter comprises two traction wires, the tube wall of the tube body is provided with two traction channels arranged symmetrically with respect to the central axis of the tube body in the axial direction, and the receiving channel is arranged between the two traction channels.

7. The valve cutting device of claim 6, wherein, The snaring catheter further comprises a tapered guide sliding head, the guide sliding head is arranged at the distal end of the adjustable bending section, the proximal end of the movable section is fixedly or movably connected with the distal end of the main body section, and the distal end of the movable section is fixedly connected with the guide sliding head.

8. The valve cutting device of claim 1, wherein, The adjustable bending section also has a flat state, in the flat state, the movable section is basically flat and closely adheres to the adjustable bending section.

9. The valve cutting device of claim 1, wherein, ​ 10. The valve cutting device of claim 1, wherein, The axial length of the adjustable bending section ranges from 1 cm to 5 cm, the cutting part is located in the middle region of the adjustable bending section in the axial direction, and the axial length of the cutting part ranges from 0.5 mm to 10 mm.

11. The valve cutting device of claim 1, wherein, The cutting member comprises a conductive core and an insulating layer wrapped around the conductive core, the insulating layer on the side of the cutting part opposite to the adjustable bending section is stripped to expose the conductive core, and the valve cutting device further comprises an energy generator electrically connected to the proximal end of the conductive core.

12. The valve cutting device of claim 1, wherein, The cutting part is a blade arranged on the side of the movable section opposite to the adjustable bending section.

13. The valve cutting device of claim 1, wherein, The valve cutting device further comprises A fixing ring is arranged outside the snaring catheter, and the adjustable bending section and the movable section are arranged in the fixing ring.

14. The valve cutting device of claim 1, wherein, The valve cutting device further comprises an operation handle fixedly connected to the proximal end of the tube body, and the operation handle is used for operating the adjustable bending section to the curved state.

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