Electric cutting device for valve leaflet

Abstract

The invention provides a valve leaflet electric cutting device which comprises a valve leaflet clamp, and two parts of the valve leaflet clamp can be oppositely opened or closed to capture or clamp a valve leaflet. When the valve leaflet clamp is closed, the cutting head is located in the valve leaflet clamp, and the cutting head is electrically connected with an external high-frequency energy generator so as to electrically cut the valve leaflet; the catheter is connected with the near end of the valve leaflet clamp and used for limiting one or more axial channels along the catheter, so that a pull wire for controlling opening and closing of the valve leaflet clamp, an insulated wire for transmitting high-frequency electric energy to a cutting head and the like penetrate through the catheter; the far end of the handle is connected with the near end of the catheter, the near end of the handle is connected with an external high-frequency energy generator so as to control the valve leaflet clamp to be opened or closed, and the cutting head moves in the axial direction of the catheter so as to electrically cut the valve leaflet. According to the valve leaflet electric cutting device, the cutting efficiency is greatly improved, and special valve leaflet such as calcification can be cut.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and particularly relates to a leaflet cutting device. BACKGROUND

[0002] There are four valves in the heart, and the valves allow blood to flow in a determined direction through the four chambers of the heart, and the valves can inhibit backflow of blood. Due to long-term work of the valves or other diseases, the valves can be damaged, and thus artificial valve intervention surgery is needed. In particular, when performing aortic replacement surgery, a very serious complication, coronary artery obstruction, can occur, and the probability of coronary artery obstruction is greatly increased when artificial valves need to be implanted again after artificial valves have been implanted. When performing mitral valve replacement surgery, a similar complication can also occur because the anterior leaflet of the mitral valve is pushed towards the aorta after replacement, thereby causing obstruction of the mitral outflow tract.

[0003] Patent WO2020234763A1 provides a leaflet cutting device, which cuts the valve by a blade, and this method has the following problems: 1) when using the device to cut, the blade needs to be pulled upwards to provide cutting force, at this time, the annulus can be deformed due to excessive pulling force; 2) if the patient has just undergone aortic replacement surgery, the implanted artificial valve has not yet endothelialized, and the rivet at the annulus is not firm, and pulling to cut the leaflet can also cause displacement of the valve; 3) if the patient's leaflet is severely calcified, it can be difficult to cut due to the hardness of the leaflet.

[0004] Therefore, it is necessary to design a device for cutting the leaflet using other methods to solve the above problems in the prior art. SUMMARY

[0005] The present application provides a leaflet cutting device. The method and device can be used to perform BASILICA leaflet resection. The device comprises: a leaflet clamp, two parts of the leaflet clamp can be opened or closed relative to each other to prepare for clamping the leaflet or clamp the leaflet; a cutting head, when the leaflet clamp is closed, the cutting head is located inside the leaflet clamp, and the cutting head is electrically connected to an external high-frequency energy generator to electrically cut the leaflet; a catheter connected to the proximal end of the leaflet clamp, for defining one or more axial channels along the catheter for passing a pull wire for controlling opening and closing of the leaflet clamp, an insulated wire for transmitting high-frequency electric energy to the cutting head, etc. A handle, a distal end of the handle is connected with a proximal end of the catheter, a proximal end of the handle 14 is connected with an external high-frequency energy generator to control opening or closing of the leaflet clamp and axial movement of the cutting head along the catheter to electrically cut the leaflet. The handle controls opening and closing of the leaflet clamp and axial movement of the cutting head, which are both prior art.

[0006] In other embodiments, the cutting head comprises a first cutting part, a second cutting part and a connecting part connecting the two, the first cutting part and the second cutting part are located on the same side of the connecting part; the cutting head is a bare conductive wire, at least the connecting part can pass through the leaflet to be cut; the first cutting part and the second cutting part are connected with the external high-frequency energy generator through insulated wires at the end away from the connecting part. During the operation, the conductive wire generates high heat after being electrified, and the heat generated causes the leaflet in contact with the cutting head to vaporize and separate from other parts of the leaflet, so as to achieve the purpose of cutting the leaflet. The design of the insulated wire of the non-cutting part can ensure the safety of the operation process and avoid electric shock of the patient or medical staff.

[0007] In other embodiments, the first cutting part and the second cutting part are located in the same plane, and preferably, the plane formed by the first cutting part and the second cutting part is perpendicular to the axis of the catheter, so that the first cutting part and the second cutting part of the cutting head can simultaneously reach the outer edge of the leaflet to complete the cutting of the leaflet during the axial movement for cutting the leaflet.

[0008] In other embodiments, in the initial state, the cutting head is located at the distal end of the leaflet clamp, and during the cutting process, it moves from the distal end to the proximal end of the leaflet clamp along the axis of the catheter.

[0009] In other embodiments, the first cutting part and the second cutting part are parallel to each other, and the cutting head has an n-shaped structure.

[0010] In other embodiments, the straight line where the first cutting part and the second cutting part are located intersects, and the cutting head has an inverted V-shaped structure.

[0011] In other embodiments, the first clamp can be opened relative to the second clamp towards the proximal end or the distal end of the leaflet cutting device to clamp the leaflet to be cut.

[0012] During the operation, the top of the cutting head first contacts the leaflet, and after being electrified, this part of the leaflet is cut by the connecting part, the connecting part passes through the leaflet in a direction perpendicular to the surface of the leaflet, and the handle controls the overall movement of the cutting head to the proximal end of the leaflet clamp, and during the movement, the first cutting part and the second cutting part simultaneously cut the leaflet along the set route.

[0013] In other embodiments, the leaflet clamp comprises a first clamp and a second clamp connected by a pin, the second clamp is fixedly connected with the catheter, the handle controls the first clamp to rotate around the pin to open and close relative to the second clamp. During the delivery of the leaflet cutting device through the patient's blood vessel, the first clamp and the second clamp are in a closed state. When the leaflet cutting device reaches the target position, the first clamp is controlled to rotate open by the handle to form a leaflet clamping space. After the leaflet to be cut enters the leaflet clamping space, the handle is adjusted in reverse to make the first clamp and the second clamp clamp to capture the leaflet, and the leaflet is fixed in the leaflet clamping space to prepare for subsequent leaflet cutting.

[0014] In other embodiments, the opposite side of the first clamp and the second clamp is provided with a clamping plane to clamp the leaflet to be cut. The cut leaflet is a foreign body to the patient and needs to be safely removed from the patient's body to prevent the cut leaflet from remaining in the body and causing blood vessel blockage. Therefore, the design of the clamping plane can increase the contact area between the leaflet clamp and the leaflet, and reduce the risk of the cut leaflet detaching from the leaflet clamp.

[0015] In other embodiments, the first cutting part and / or the second cutting part is at an angle with the clamping plane, the angle α = 75°-100°, preferably, the angle α = 90°, that is, the first cutting part and / or the second cutting part is perpendicular to the clamping plane, so that the cutting head bears less pressure during the cutting of the leaflet to pass through the leaflet, and it is easier to determine the relative position of the first cutting part and / or the second cutting part and the leaflet during the operation, so as to facilitate the medical staff to determine the cutting site.

[0016] In other embodiments, the first clamp is provided with a first guide groove, and the cutting head can move at least partially along the guide groove. Preferably, the guide groove is a through groove, and the connecting part of the cutting head passes through the guide groove to isolate the leaflet, so as to avoid the connecting part cutting the side surface of the separated leaflet while the first cutting part and / or the second cutting part cuts the leaflet and the other part of the valve. The effect is that the electric energy can be more concentrated in the first cutting part and / or the second cutting part to reduce the energy consumption. On the other hand, it avoids the connecting part applying heat to the cut leaflet to burn the surface of the cut leaflet.

[0017] In other embodiments, the guide groove has a U-shaped structure, and the first clamp further includes a pressure tongue located inside the guide groove. When the leaflet clamp is closed, the connecting portion passes through the pressure tongue and can move along the axial direction of the pressure tongue. The pressure tongue can both fix the cut leaflet between the first clamp and the second clamp, preventing the risk of vascular blockage caused by the cut leaflet detaching, and also isolate the connecting portion from the cut leaflet, preventing thermal damage to the surface of the cut leaflet by the connecting portion.

[0018] The pressure tongue serves two purposes: firstly, to guide the movement of the cutting head, and secondly, to press the valve firmly between the first and second clamps. Preferably, the pressure tongue is made of a material with high hardness, such as a high-hardness polymer material like ABS, or a metal material like manganese steel alloy or tungsten steel alloy.

[0019] In other embodiments, the second clamp and / or the clamping plane of the first clamp are provided with at least one protruding pin, such as two, three or more protruding pins. The angle β between the protruding pin and the clamping plane is 60°-95° ​​to ensure that the protruding pin can more smoothly puncture the leaflet to be cut, and to prevent the cut leaflet from falling out of the leaflet clamp due to the impact of blood flow, causing embolism.

[0020] Preferably, the longitudinal section of the free end of the protruding needle is triangular, such as an acute triangle and / or a right triangle, to improve the ability of the protruding needle to puncture the leaflet.

[0021] In other embodiments, the second fixture is provided with a second guide groove and a third guide groove, and the first cutting part and the second cutting part can move along the second guide groove and the third guide groove respectively to ensure that the leaf cutting is carried out along a predetermined track.

[0022] In other embodiments, the second clamp is provided with a guide wire hole along the axial direction. During the operation, the leaflet electrocautery device provided by the present invention can smoothly enter the predetermined position through the guide wire hole along the guide wire.

[0023] In other embodiments, the insulated wire that transmits high-frequency electrical energy to the cutting head is a conductor, and the conductor is made of a conductive metal, such as copper wire or stainless steel.

[0024] In other embodiments, to improve the safety of the leaflet electrocautery device during surgery, a protective sleeve may be provided on the outside of the wire. The protective sleeve serves as insulation and also as heat insulation and flame retardant. The material of the protective sleeve may be asbestos, PI, PTFE, PVC, etc.

[0025] In other embodiments, the catheter has multiple cavities inside, such as a guidewire cavity, a push-pull rod cavity for controlling the opening and closing of the clamp, and a wire cavity for two wires that respectively deliver high-frequency energy to the first cutting section and the second cutting section.

[0026] In other embodiments, in order to allow the catheter to have better flexibility during the procedure so as to pass smoothly through the blood vessel to the target location, the distal end of the catheter is less rigid than its proximal end. Preferably, the distal end of the catheter is made of block polyetheramide resin (PEBAX) material.

[0027] In other embodiments, the handle is provided with a clamp opening / closing knob and a cutting movement knob. The clamp opening / closing knob controls the axial movement of the push-pull rod to open or close the leaf clamp. The cutting movement knob controls the forward and backward movement of the wire, thereby driving the cutting head to move forward and backward.

[0028] The leaflet electrocautery device provided by this invention first uses a leaflet clamp to hold and fix the leaflet to be cut, and then uses the heat generated by the high-frequency energy of the cutting head to cut the leaflet. The leaflet electrocautery device provided by this invention can also be performed in other cardiac surgeries, such as cutting or dividing the anterior or posterior leaflet of the mitral valve into two leaflets, thereby preparing for TAVR or other cardiac surgeries.

[0029] This leaflet electrocautery device first fixes the leaflet with a leaflet clamp before cutting. The leaflet is not subjected to force or is subjected to minimal force during the cutting process, which will not affect other parts around the leaflet, such as the valve annulus, thus avoiding affecting the stability of newly implanted artificial heart valves and other devices. This leaflet electrocautery device uses high-frequency energy to generate heat to evaporate tissue and cut the leaflets, instead of using mechanical force as in existing technologies. Therefore, it can cut leaflets with severe calcification without affecting the surgical outcome.

[0030] After leaflet removal, this leaflet electrocautery device removes the cut leaflet tissue from the body. For patients with a large area of ​​leaflet covering the coronary artery ostium, or those requiring leaflet removal from both coronary artery ostia, the cutting head can be returned to its initial position by releasing the cutting movement knob on the handle. This allows for repeated leaflet removal, significantly reducing the patient's surgical costs.

[0031] This leaflet electrocautery device uses both a first cutting section and a second cutting section simultaneously to cut the leaflet, essentially using two cutting blades at the same time. Compared to the single-blade cutting of leaflets in existing technologies, the leaflet cutting time is reduced by at least 50%, which can alleviate patient pain and improve surgical efficiency. Attached Figure Description

[0032] The invention will be more fully understood and appreciated from the following detailed description, taken in conjunction with the accompanying drawings, in which: Figure 1A A schematic diagram of the overall structure of a leaflet electrocautery device for aortic valve electrocautery provided by the present invention; Figure 1B This is a schematic diagram of using the leaflet electro-cutting device provided by the present invention to clamp and / or cut the aortic leaflet; Figure 1C From left to right are schematic diagrams of the shape of the leaflets before and after cutting; Figure 2A This is a schematic diagram of the valve clamp in the closed state in one embodiment; Figure 2B This is a schematic diagram of the leaflet clamp in the open state in one embodiment; Figure 3 This is a schematic diagram of the structure of the clamping surface of the first fixture in one embodiment; Figure 4A This is a schematic diagram of the clamping surface of the second fixture in one embodiment; Figure 4B In one embodiment, the second clamp is along Figure 4A Cross-sectional view of the AA plane; Figure 4C This is a schematic diagram of the assembly of the cutting head and the second clamp in one embodiment; Figure 5A , 5B 5C is a schematic diagram of the structure of different shaped cutting heads in one embodiment; Figure 6 This is a schematic diagram of the wire structure in one embodiment; Figure 7 This is a schematic diagram of a catheter structure in one embodiment; Figure 8 This is a schematic diagram of the handle structure in one embodiment.

[0033] Figure 9 A schematic diagram of the overall structure of the leaflet electrocautery device provided by the present invention applied to aortic valve electrocautery. Figure 10 This is a schematic diagram of the valve leaflet clamp in the closed state of an aortic valve electrocautery device. Figure 11 A schematic diagram of the valve leaflet clamp in the open state of an aortic valve electrocautery device; Figure 12 for Figure 11 A perspective view.

[0034] 1. Leaflet electrocautery device; 10. Leaflet clamp; 11. Cutting head; 12. Wire; 13. Catheter; 14. Handle; 15. High-frequency generator; 16. Adjustable bendable catheter sheath; 101. First clamp; 1011. Depressor; 1012. First guide groove; 102. Second clamp; 1021. Protruding needle; 1022. Second guide groove; 1022'. Third guide groove; 1023. Clamp guide wire cavity; 103. Rotating shaft; 111. First cutting part; 111'. Second cutting part; 112. Connecting part; 113. Cutting head base; 121. Wire shaft; 122. Wire coating; 131. Catheter guide wire cavity; 132. Wire cavity; 133. Push-pull rod cavity; 1401. Handle housing; 1402. Clamp opening / closing knob; 1403. Cutting movement knob. Detailed Implementation

[0035] To more clearly illustrate the embodiments of the present invention, specific implementations will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present invention. Those skilled in the art can obtain other drawings and other implementations based on these drawings, and all such other implementations should be covered within the scope of the present invention.

[0036] It should be noted that in this invention, the proximal end refers to the end closest to the handle, i.e., the end operated by medical personnel, while the distal end refers to the end opposite to the proximal end.

[0037] For reference Figure 1A This is a non-limiting embodiment of the leaflet electrocautery device provided by the present invention. For example... Figure 1A As shown, the leaflet electrocautery device 1 includes a leaflet clamp 10, a cutting head 11, a catheter 13, and a handle 14. The leaflet clamp 10 is used to hold and fix the leaflet to be cut during surgery and to prevent the cut leaflet from falling out of the clamp 10. When the leaflet clamp 10 is in the closed clamping state, the cutting head 11 is located inside the leaflet clamp 10. When the cutting head 11 is connected to a high-frequency energy generator, the high temperature generated by the high instantaneous high current can vaporize the leaflet tissue in contact with the cutting head 11 to achieve the purpose of electrocautery of the leaflet. The catheter 13 is connected to the proximal end of the leaflet clamp 10 and is used to define one or more channels along the longitudinal direction or axis of the catheter 13. During surgery, the catheter 13 delivers the leaflet clamp 10 and the cutting head 11 along the patient's blood vessels to the target location, such as the aortic root to cut the aortic leaflet, or the mitral valve to cut the mitral valve leaflet. The distal end of the handle 14 is connected to the proximal end of the catheter 13, and the proximal end of the handle 14 is connected to an external high-frequency energy generator to control the opening or closing of the leaflet clamp 10, and the cutting head 11 moves along the axial direction of the catheter 13 to electrically cut the leaflets.

[0038] Although Figure 1AThe diagram shows a high-frequency generator 14, but this leaflet electrocautery device generally does not need to include a high-frequency generator 14. The high-frequency generator 14 is provided by the user, such as a hospital. The leaflet electrocautery device provided by this invention only needs to be connected to an existing high-frequency generator.

[0039] like Figure 1B The diagram shows a schematic of the valve leaflet electrocautery device provided by the present invention used in surgery. The catheter 13 delivers the valve leaflet clamp 10 and the cutting head 11 (not shown) to the root of the aorta along the guide wire (not shown) pre-implanted in the blood vessel. The valve leaflet clamp 10 clamps the leaflet to be cut by the control structure on the operating handle, preparing for subsequent valve leaflet cutting.

[0040] Figure 1C The diagram illustrates the aortic valve leaflet removal process before and after the procedure. Before leaflet removal, part of the leaflet obstructs the coronary ostium. Therefore, before heart valve replacement surgery, this portion of the leaflet obstructing the coronary ostium needs to be removed to avoid fatal problems such as coronary artery blockage. After the excess leaflet is removed using the leaflet electrocautery device provided by this invention, the coronary ostium is exposed. Because the artificial heart valve is implanted, the leaflets adjacent to the removed leaflets are compressed and moved laterally by the implanted artificial heart valve, thus further distancing them from the coronary ostium to ensure that they will not obstruct the coronary ostium again during subsequent surgeries.

[0041] To illustrate the specific structure of the leaflet electrocautery device provided by the present invention Figure 2A and Figure 2B The leaflet clamp 10 is shown in two states: closed and open. The leaflet clamp 10 mainly comprises three components: a first clamp 101, a second clamp 102, and a rotating shaft 103 connecting the first and second clamps. The proximal end of the second clamp 102 is fixedly connected to the distal end of the catheter 13, such as by welding, screwing, bonding, or other methods. The first clamp 101 is rotatably connected to the second clamp 102 via the rotating shaft 103. The first clamp can rotate around the rotating shaft under the action of a push-pull rod, thereby opening or closing the leaflet clamp 10. To avoid damage to the patient's blood vessels by the cutting head during intravascular delivery of the leaflet electrocautery device, in this embodiment, the leaflet clamp 10 is in the closed state during delivery, i.e., the first clamp and the second clamp 102 are located on the same side of the rotating shaft 103. Of course, if the cutting head is properly protected, the leaflet clamp 10 can also be in the open state during delivery to further reduce the radial width of the leaflet clamp 10 during delivery. In this state, after the leaflet clamp 102 reaches the target position, the first clamp 101 needs to rotate 180° to close the leaflet clamp 10 or clamp the leaflet to be cut.

[0042] This example illustrates the operation of conveying the leaflet clamp 10 to the target position, using the clamped state during the conveying process as an example. Figure 2B As shown, by controlling the push-pull rod at the handle end to rotate the first clamp 101 away from the second clamp 102, the leaf clamp 10 is opened to prepare for capturing and holding the leaf to be cut. After capturing the leaf, the push-pull rod moves in the opposite direction to put the leaf clamp 10 back into the clamping state, so as to clamp the leaf to be cut between the first clamp 101 and the second clamp 102, in preparation for subsequent electrical cutting of the leaf.

[0043] like Figure 4A , 4B The diagram shows the second clamp 102 of the leaflet electrocautery device provided by the present invention. To ensure that the leaflet clamp 10 can firmly hold the leaflet to be cut and to avoid the risk of electric shock to the patient and / or medical staff during the electrocautery process, the second clamp 102 can be made of a material with certain strength and insulation capabilities, preferably PEEK, POM, ceramics, etc. The sides where the second clamp 102 and the first clamp are clamped together are basically planar. To avoid the risk of leaflet escape or blockage of blood vessels after clamping or cutting the leaflet, the plane of the second clamp 102 is also provided with a protruding needle 1021. The number of protruding needles 1021 can be one, two, three or more. The protruding needles 1021 can be located at the edge or middle of the plane of the second clamp 102, preferably at the middle. The protruding needles 1021 should have a certain puncture capability, such as the free end of the protruding needle 1021 being preferably conical. That is, after the leaflet to be cut is clamped by the leaflet clamp 10, the protruding needle 1021 should be able to penetrate the leaflet to prevent the leaflet from escaping after clamping, thus preventing the need for secondary or multiple leaflet captures, or the cut leaflet from being flushed out of the leaflet clamp by blood flow, causing embolism in the patient. The fixing needle 1021 can be made of stainless steel and is fixed to the side of the second clamp 102 facing the first clamp 101 by adhesive bonding.

[0044] To facilitate the axial movement of the cutting head 11 along the guide tube 13, a guide groove can also be provided on the second clamp 102, such as... Figure 4A , Figure 4C As shown, the second clamp 102 has a second guide groove 1022 and a third guide groove 1022' on both sides. From Figure 4BAs shown in the cross-sectional view of the second clamp 102, the cross-sectional shapes of the second guide groove 1022 and the third guide groove 1022' are approximately "L"-shaped, meaning that the upper width of the second guide groove 1022 and the third guide groove 1022' is smaller than the lower width. This design allows the cutting head 11 to be secured within the second guide groove 1022 and the third guide groove 1022', preventing the cutting head 11 from dislodging from the guide groove during its movement along the guide groove. The second guide groove 1022 and the third guide groove 1022' have similar structures and face the same or opposite directions; therefore, only the second guide groove 1022 will be described here as an example. The upper width of the second guide groove 1022 is 0.3mm-0.6mm, and the lower width of the second guide groove 1022 is 0.6mm-1.2mm, preferably 0.8mm-1mm. The width or diameter of the portion connecting the cutting head 11 to the wire is greater than the upper width of the second guide groove 1022 but smaller than the lower width of the second guide groove 1022. In its initial state, the cutting head 11 is located at the far end of the second clamp 102 and can move towards the proximal end along the second guide groove 1022 and the third guide groove 1022'.

[0045] To facilitate the leaflet clamp 10 reaching the target position along the guidewire, a guidewire cavity can also be provided on the leaflet clamp 10, such as... Figure 4B As shown, the lower part of the second clamp 102 is also provided with a clamp guide wire cavity 1023, the diameter of which is 0.9mm-1.2mm, which is larger than the diameter of the guide wire.

[0046] like Figure 5A , 5B Figure 5C shows three structural schematic diagrams of the cutting head 11 of the leaflet electrocutting device provided by the present invention. The cutting head 11 includes a first cutting part 111, a connecting part 112, and a second cutting part 111' located on the same plane. The two ends of the connecting part 112 are fixedly connected to the first cutting part 111 and the second cutting part 111', respectively. These connections can be made by welding, or the cutting head 11 can be integrally cut. The plane where the cutting head 11 is located is perpendicular to the clamping plane of the second clamp 102 toward the first clamp 101. The ends of the first cutting part 111 and the second cutting part 111' away from the connecting part 112 are respectively provided with cutting head feet 113 and 113'. When the cutting head 11 is engaged with the second clamp 102, the cutting head feet 113 and 113' are located in the second guide groove 1022 and the third guide groove 1022'. When the cutting head 11 electrocuts the leaflet, the cutting head feet 113 and 113' move along the second guide groove 1022 and the third guide groove 1022'. To further facilitate the cutting head 11 passing through the leaflet to be cut, such as Figure 5C As shown, the connecting part 112 is narrow in the middle and wide at both ends. When the leaflet clamp 10 holds the leaflet, the connecting part 112 can provide greater pressure when it abuts against one side of the leaflet to facilitate passing through the leaflet.

[0047] In a preferred embodiment, the first cutting portion 111 and the second cutting portion 111' are parallel to each other, the connecting portion 112 is arc-shaped, and the cutting head 11 has an n-shaped structure.

[0048] In other embodiments, the straight lines containing the first cutting portion 111 and the second cutting portion 111' intersect, and the cutting head 11 has an inverted V-shaped structure; of course, the first cutting portion 111 and the second cutting portion 111' may not be straight lines, but rather have a certain curvature, as long as the cut leaflets do not obstruct the coronary artery orifice.

[0049] The cutting head base 113 is designed to connect to the wire. Preferably, in the initial state, the cutting head is located at the distal end of the second clamp 102. That is, during the clamping and cutting of the leaflet, the outer side of the connecting part 112 first abuts against one side of the leaflet. After energization, the connecting part 112, which first contacts the leaflet, passes vertically through the leaflet. Then, the cutting head 11 is controlled by the handle to move from the distal end along the second guide groove 1022 and the third guide groove 1022' towards the proximal end. During the movement, the first cutting part 111 and the second cutting part 111' cut the leaflet simultaneously. In other words, the cutting head only needs to move once from the distal end to the proximal end of the second clamp 102 to complete one leaflet cutting, unlike the cutting method in the prior art, which requires moving around the cutting path of the leaflet to cut it off. That is, during the leaflet cutting process, using the leaflet electrocautery device provided by this invention, the cutting path of the cutting head 11 can be shortened by at least 50%, thus significantly reducing the cutting time and alleviating the patient's pain.

[0050] In other embodiments, to make it easier for the cutting head to pierce the leaflet, the side of the connecting portion 112 facing the leaflet to be cut can be configured as a sharper structure, such as the outer cross-section of the connecting portion 112 being a triangular structure, so that when the connecting portion 112 passes through the leaflet, it is easier to pierce the leaflet to be cut.

[0051] Similar to the connecting part 112, the first cutting part 111 and the second cutting part 111' facing the handle can also be configured with a sharper structure, and the outer cross-section can be a triangular structure, so that when the cutting head moves towards the handle to cut the leaflet, there is a smaller contact surface with the leaflet to be cut, so as to assist in cutting the leaflet and reduce the use of high-frequency energy.

[0052] The first cutting section 111, the connecting section 112, the second cutting section 111', and the cutting head bases 113 and 113' can be made of stainless steel or tungsten carbide sheets through cutting and bending. They are then spliced ​​with the wire. Alternatively, they can be an integral structure with the wire shaft, formed by directly bending the wire to form the first cutting section 111, the connecting section 112, the second cutting section 111', and the cutting head bases 113 and 113'.

[0053] The first cutting part 111, the connecting part 112, and the second cutting part 111' can form a U-shaped, V-shaped, or arc-shaped structure, as long as the width of the cut-off petals meets the requirements. To improve the stability of the connection between the cutting head bases 113 and 113' and the wires, a concave shape can be provided in the middle of the cutting head bases 113 and 113', and the wires can be inserted into the concave part to increase the contact area of ​​the cutting head bases 113 and 113'.

[0054] like Figure 3 The diagram shows a schematic of the first clamp 101 in the leaflet electrocautery device provided by the present invention. The first clamp 101 requires a certain strength and insulation capability; therefore, materials such as PEEK and ceramics are preferred. A first guide groove 1012, which mates with the cutting head 11, is provided in the middle of the first clamp 101. Preferably, the first guide groove 1012 extends through the first clamp 101. When the cutting head 11 moves along the second guide groove 1022 and the third guide groove 1022', the connecting part 112 moves along the first guide groove 1012. The first guide groove 1012 has a U-shaped structure, and its axis of symmetry is aligned with the axial direction of the conduit. A pressure tongue 1011 is located in the middle of the first guide groove 1012. The pressure tongue 1011 can be an integral structure with the first clamp 101, or it can be assembled onto the first clamp 101 by welding or other methods. The depressor needs to be strong enough to provide sufficient pressure to the valve, so that the leaflet to be cut is firmly clamped between the depressor 1011 and the second clamp 102. The preferred material for the depressor 1011 is PEEK, POM, ceramic, stainless steel, etc. The distal end of the depressor has a tapered structure, which facilitates the passage of the cutting head 11 through the depressor 1011. The depressor 1011 also serves to isolate the connecting part 112 and the leaflet during the movement of the cutting head proximally to cut the leaflet, thus preventing the connecting part from cutting the side of the leaflet and preventing the leaflet from scorching or vaporizing.

[0055] like Figure 6As shown, the lead wire 12 includes a lead wire core 121 and a lead wire sheath 122 covering the outer periphery of the lead wire core 121. The lead wire sheath 122 encloses the lead wire core 121. The lead wire core 121 needs to have excellent conductivity and tensile strength, and its material can be copper wire, tungsten wire, or stainless steel wire. During use, the lead wire 12 is in a taut state, and the handle pulls the cutting head 11 proximally through the lead wire 12 to cut the leaflet. After the leaflet is cut, the handle is released, and the cutting head 11 automatically returns to its initial position. The lead wire sheath 122 serves two purposes: insulation and preventing the lead wire core 121 from contacting the patient's blood to reduce heat loss from the lead wire. Its material can be PI, PVC, PTEF, or other polymer materials with insulating and heat-insulating properties.

[0056] In one embodiment, such as Figure 7 The diagram shows a schematic of catheter 13. Catheter 13 connects the leaflet clamp 10 and the handle 14, and provides channels for the guidewire (not shown), lead wire 12, and push-pull rod 1405. Therefore, the catheter has a multi-lumen design with four lumens: one guidewire lumen 131, two lead wire lumen 132, and one push-pull rod lumen 133. During use, catheter 13 needs to be accessed via the femoral artery, proceeding along the abdominal aorta to the aortic valve, or via the femoral vein along the inferior vena cava across the interatrial septum to the mitral valve. Therefore, catheter 13 requires a certain degree of flexibility and torsion; preferably, it can be made of PEBAX material.

[0057] like Figure 8 The diagram shows a schematic of the handle 14. The handle 14 functions to control the opening and closing of the leaflet clamp 10 to capture or hold the leaflets, and to move the cutting head 11 from the distal end to the proximal end to cut the leaflets. The handle 14 includes a handle housing 1401, a clamp opening / closing knob 1402, and a cutting movement knob 1403. Rotating the clamp opening / closing knob 1402 opens or closes the clamp 10, and rotating the cutting movement knob 1403 moves the cutting head 11 to cut the leaflets. The control of the opening and closing of the leaflet clamp 10 and the axial movement of the cutting head 11 by the handle 14, based on the description in this embodiment, utilizes existing technology to control their movement.

[0058] The high-frequency generator 15 used in conjunction with the leaflet electric cutting device provided by the present invention can generate energy of not less than 20W and can be connected to the handle to provide energy to the cutting head through the wire.

[0059] The following uses aortic valve cutting as an example to illustrate the method of using the leaflet electrocautery device provided by this invention: First, a guidewire is punctured at the femoral artery and delivered to the aortic valve. Then, the catheter sheath assembly is delivered along the guidewire to the aorta. The dilator is withdrawn, and the leaflet electrocautery system provided by this invention is delivered to the position where the leaflet needs to be cut through the delivery path formed by the catheter sheath. The clamp opening and closing knob 1402 of the operating handle 14 opens the leaflet clamp 10 to capture the leaflet. After capture, the leaflet clamp 10 is closed, and high-frequency energy is generated by the high-frequency generator and transmitted to the cutting head 11 through the wire. After the connecting part 112 of the cutting head 11 passes through the leaflet, the cutting movement knob 1403 is operated to make the cutting head 11 move towards the proximal end along the second guide groove 1022 and the third guide groove 1022', thereby realizing the cutting of the valve. After the valve is cut, the leaflet electro-cutting device is withdrawn through the catheter sheath to complete the cutting of one leaflet. The clamp opening and closing knob 1402 and the cutting movement knob 1403 are released to make the cutting head 11 return to the initial position, that is, at the distal end of the second clamp 102, and the leaflet clamp 10 is opened to remove the cut leaflet.

[0060] If the leaflets need to be cut again, the leaflet clamp 10 can be closed, and the leaflet electro-cutting system provided by the present invention can be transported along the delivery path formed by the catheter sheath to the position where the leaflets need to be cut and the above cutting process can be repeated. After confirming that all the leaflets that need to be cut have been completed, the adjustable bendable catheter sheath can be withdrawn to complete the operation.

[0061] like Figure 9 The diagram shows the leaflet electrocautery device provided by this invention used for mitral valve leaflet electrocautery. The device enters the right atrium via the right femoral vein and inferior vena cava, passes through the interatrial septum, enters the left atrium, and crosses the mitral valve to capture the anterior leaflet. The adjustable catheter sheath 16 is an adjustable structure that provides a channel for the electrocautery section; both are existing technologies, and their specific structures will not be described in detail here. The focus here is on explaining the difference between the leaflet clamp 10 and the aortic electrocautery device.

[0062] Because the mitral valve leaflet free end faces distal to the cutting device after entering the left ventricle from the left atrium, unlike the aortic valve leaflet free end which faces proximal to the cutting device, in order to better capture the mitral valve leaflet, such as... Figures 10-12As shown, the leaflet clamp 10 is also adaptively adjusted so that the first clamp 101 can open relative to the second clamp 102 towards the proximal end of the electric cutting device. The specific structure of the leaflet clamp 10 is as follows: The leaflet clamp 10 mainly includes three components: the first clamp 101, the second clamp 102, and a rotating shaft 103 connecting the first clamp and the second clamp. The first clamp 101 is also provided with an arc-shaped guide groove 104, through which the first clamp 101 opens or closes relative to the second clamp 102. The proximal end of the second clamp 102 is fixedly connected to the distal end of the conduit 13, such as by welding, screwing, bonding, or other methods. The distal end 105 of the first clamp 101 is fixedly connected to a push-pull rod 17. Under the drive of the push-pull rod 17, the first clamp 101 can rotate around the rotating shaft, thereby realizing the opening or closing of the leaflet clamp 10. To prevent damage to the patient's blood vessels by the cutting head during delivery of the leaflet electrocautery device, in this embodiment, the leaflet clamp 10 is in a closed state during delivery, meaning the first clamp and the second clamp 102 are located on the same side of the rotating shaft 103. The push-pull rod 17 can open the first clamp 101 relative to the second clamp 102 by an angle of γ=0-80°.

[0063] When cutting the mitral valve leaflet, in the initial state, the cutting head 11 is located on the proximal side of the second clamp 102. In order to cooperate with the cutting head 11, the distal end of the pressure tongue 1011 provided on the first clamp 101 is fixed on the first clamp 101, and the proximal end is suspended, leaving a gap for the cutting head 11 to pass through.

[0064] The above description is only a preferred embodiment of this patent. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this invention, and these improvements and modifications should also be considered within the scope of protection of this invention.

Claims

1. A leaflet electro-cutting device, characterized in that, The device includes: Leaflet clamp 10; When the leaflet clamp 10 is closed, the cutting head 11 is located inside the leaflet clamp 10, and the cutting head 11 moves in one direction to complete the electric cutting of the leaflet; The catheter 13 is connected to the proximal end of the leaflet clamp 10 and is used to define one or more axial channels along the catheter 13; Handle 14, the distal end of which is connected to the proximal end of the catheter 13, and the proximal end of which is connected to an external high-frequency energy generator to control the opening or closing of the leaflet clamp 10 and the movement of the cutting head 11 along the axial direction of the catheter 13 to electrically cut the leaflets.

2. The leaflet electrocautery device according to claim 1, characterized in that, The cutting head includes a first cutting section, a second cutting section, and a connecting section connecting the two. The first cutting section and the second cutting section are located on the same side of the connecting section. The cutting head is an exposed conductive metal wire, and at least the connecting section can pass through the leaf to be cut. The ends of the first cutting section and the second cutting section away from the connecting section are connected to an external high-frequency energy generator through insulated wires.

3. The leaflet electrocautery device according to claim 1, characterized in that, The first cutting portion and the second cutting portion are located on the same plane.

4. The leaflet electrocautery device according to claim 3, characterized in that, The first and second cutting sections are parallel to each other, and the cutting head has an n-shaped structure; or The first cutting section and the second cutting section are located on a straight line that intersects, and the cutting head has an inverted V-shaped structure.

5. The leaflet electrocautery device according to claim 1, characterized in that, The leaflet clamp includes a first clamp and a second clamp connected by a pin. The second clamp is fixedly connected to the catheter. The handle controls the first clamp to rotate around the pin so as to perform an opening and closing motion relative to the second clamp.

6. The leaflet electrocautery device according to claim 5, characterized in that, The first clamp can be opened relative to the second clamp toward the proximal or distal end of the leaflet electrocutting device to clamp the leaflet to be cut.

7. The leaflet electrocautery device according to claim 2, characterized in that, The first clamp and the second clamp have clamping planes on opposite sides to clamp the petals to be cut.

8. The leaflet electrocautery device according to claim 5, characterized in that, The first cutting portion and / or the second cutting portion are perpendicular to the clamping plane.

9. The leaflet electro-cutting device according to claim 2, characterized in that, The first fixture is provided with a first guide groove, and the cutting head can move at least partially along the guide groove.

10. The leaflet electrocautery device according to claim 2, characterized in that, The guide groove passes through the first clamp and has a U-shaped structure. The first clamp also includes a pressure tongue located inside the guide groove. When the leaf clamp is closed, the connecting part passes through the pressure tongue and can move along the axial direction of the pressure tongue.

11. The leaflet electrocautery device according to claim 2, characterized in that, The second clamp and / or the clamping plane of the first clamp are provided with at least one protruding pin, and the angle β between the protruding pin and the clamping plane is 60°-95°.

12. The leaflet electrocautery device according to claim 2, characterized in that, The second fixture is provided with a second guide groove and a third guide groove, and the first cutting part and the second cutting part can move along the second guide groove and the third guide groove, respectively.

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