Leaflet cutting device and system

Abstract

The present invention relates to a leaflet cutting device and system, wherein the leaflet cutting device includes at least a distal cutting part, which includes a main body, a cutting head, a clamping arm, and a moving part; the cutting head is arranged inside the main body and can move axially between the distal end and the proximal end of the main body, and the cutting head is provided with bilateral blades for cutting the leaflets; the proximal end of the clamping arm is rotatably connected to the main body, and the distal end is used to clamp and fix the leaflets; the moving part is slidably connected to the clamping arm, and the moving part can move axially relative to the main body, and is used to drive the clamping arm to rotate around the main body to realize the opening and closing of the clamping arm; when the clamping arm closes and fixes the leaflet, the axial movement of the cutting head realizes the cutting of the fixed leaflet.

Description

Technical Field

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

[0002] Aortic stenosis is a common cardiovascular disease with a high mortality rate. In recent years, the development of transcatheter aortic valve replacement (TAVR) technology has revolutionized the treatment of aortic stenosis. However, the risk of coronary artery obstruction is a key challenge in procedures such as TAVR, ViV-TAVR (valve-in-valve TAVR), and Redo-TAVR (repeat TAVR), limiting the application of these technologies in the larger population of elderly patients with aortic valve disease.

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

[0004] Studies have shown that the BASILICA technique has a high success rate and can effectively reduce the incidence of coronary artery obstruction. However, despite its potential in preventing coronary artery obstruction, the BASILICA technique still has some shortcomings, particularly the lack of a device specifically designed for leaflet cutting, which limits its further development and application. Summary of the Invention

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

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

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

[0008] -Main body;

[0009] - a cutting head, disposed inside the main body, capable of axially moving between the distal end and the proximal end of the main body, the cutting head having bilateral cutting edges for cutting the leaflets;

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

[0011] - a moving member, slidably connected to the clamping arm, capable of axially moving relative to the main member, and used to drive the clamping arm to rotate around the main member to achieve opening and closing of the clamping arm;

[0012] When the clamp arms are closed and the leaflets are fixed, the axial movement of the cutter head realizes cutting of the fixed leaflets.

[0013] As a preferred technical solution, the main body includes:

[0014] - a main body portion, having a hollow inner cavity and a blade guide groove; the hollow inner cavity has a distal opening and a proximal opening for passing a guide wire; the blade guide groove is separated from the hollow inner cavity and is used to accommodate axial movement of the blade;

[0015] - a guide portion connected to the distal opening and communicating with the hollow inner cavity.

[0016] As a preferred technical solution, the main body portion includes a rigid material; and the guide portion includes a soft material.

[0017] As a preferred technical solution, the cutter head includes:

[0018] - a cutter head body, wherein the height of the cutter head body is smaller than the radius of the main body, and the double-sided blades are obliquely arranged on the cutter head body, with the outer blades of the double-sided blades facing the distal end and the inner blades of the double-sided blades facing the proximal end;

[0019] - a control rod connected to the proximal end of the cutter head body and used to control the axial movement of the cutter head body in the cutter head guide groove.

[0020] As a preferred technical solution, the control rod includes a conductive material and is electrically connected to the blade body. At least one side of the blade of the blade body includes a conductive material, which is used to achieve electrical cutting of the leaflet tissue when power is applied; the main body and the guide part both include electrically insulating materials.

[0021] As a preferred technical solution, the cutter head guide groove includes:

[0022] - A blade hidden cavity, with a blade hidden cavity provided at both the proximal and distal ends of the blade guide groove, the length of which is not less than the length of the blade body, and the height of which is greater than the height of the blade body;

[0023] - A guide cavity is provided in the middle of the guide groove of the cutter head, and the side of the guide cavity is open. When the cutter head body moves in the guide cavity, the cutting operation on the leaflet is realized.

[0024] As a preferred technical solution, the clamping arm is connected to the main body through a pivot connection structure to form a rotatable hinge point; a first boss is provided on the proximal side of the hinge point, and the first boss is slidingly connected to the moving part; the axial movement of the moving part drives the clamping arm to rotate around the hinge point to achieve opening and closing. When the clamping arm is in a closed state, the outer surface of the clamping arm and the outer contour of the hidden cavity are located on the same cylindrical surface.

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

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

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

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

[0029] The catheter part includes an inner sheath tube and a middle sheath tube, wherein the distal end of the middle sheath tube is connected to the moving part, and the distal end of the inner sheath tube is connected to the main body part;

[0030] The proximal operating part includes an operating handle, in which a clamping arm opening and closing mechanism and a cutter head moving mechanism are provided. The clamping arm opening and closing mechanism is used to control the opening and closing of the clamping arm, and the cutter head moving mechanism is used to control the movement of the cutter head.

[0031] As a preferred technical solution, a middle sheath fixing piece is provided at the distal end of the operating handle, the middle portion of the middle sheath fixing piece is passed through, and the proximal end of the middle sheath tube is passed through the middle sheath fixing piece and fixedly connected thereto;

[0032] The clamp arm opening and closing mechanism can control the axial movement of the middle sheath fixing part relative to the operating handle, and drive the axial movement of the middle sheath tube, and finally drive the clamp arm to open and close through the axial movement of the moving part.

[0033] As a preferred technical solution, a second boss is provided on the outer side of the middle sheath fixing part, and the clamp arm opening and closing mechanism includes a middle sheath rotating part, which is rotatably arranged on the outer side of the distal end of the operating handle. A sliding groove is provided on the inner side of the middle sheath rotating part for twisting, and the second boss is arranged in the sliding groove. The rotation of the middle sheath rotating part can make the second boss move in the sliding groove, thereby driving the axial movement of the middle sheath fixing part.

[0034] As a preferred technical solution, limiting grooves are respectively provided at both ends of the slide groove, and the limiting grooves are used to limit the opening and closing angles of the clamping arm or maintain the closed state of the clamping arm.

[0035] As a preferred technical solution, the inner sheath is configured as a double-lumen tube, including a first lumen and a second lumen, the first lumen and the second lumen being separated and arranged at the proximal end, the first lumen being used for passing the guide wire, and the second lumen being used for passing the control rod of the blade;

[0036] An inner sheath fixing piece is fixedly connected inside the operating handle, and the separated first cavity and second cavity are both passed through the inner sheath fixing piece and fixedly connected thereto.

[0037] As a preferred technical solution, the cutter head moving mechanism is arranged at the proximal end of the operating handle, and includes a threaded moving part and a threaded rotating part;

[0038] The proximal end of the first cavity is disposed through the threaded rotating member.

[0039] The proximal end of the second cavity is connected with the threaded moving member, and the control rod passes through the second cavity and is fixedly connected with the threaded moving member.

[0040] As a preferred technical solution, the threaded moving member is assembled inside the proximal end of the operating handle, and its surface is provided with an external thread;

[0041] The threaded rotating member is rotatably assembled on the proximal end of the operating handle, and the threaded rotating member is provided with an internal thread matching the threaded moving member; the rotation of the threaded rotating member is used to drive the axial movement of the threaded moving member, and then drive the movement of the control rod, and finally realize the axial movement of the cutter head.

[0042] On the other hand, the present invention also provides a leaflet cutting system, comprising the above-mentioned leaflet cutting device and a bending control delivery device.

[0043] As an optimal technical solution, the bending control delivery device includes an outer sheath and a bending control handle. The lumen of the outer sheath is used to pass through the middle sheath, and the proximal end of the outer sheath is passed through the bending control handle. The bending control handle is used to adjust the bending angle of the outer sheath.

[0044] As a preferred technical solution, the bending control delivery device further includes a middle sheath locking knob, which is arranged at the proximal end of the bending control handle and can be interference fit with the middle sheath tube to lock it.

[0045] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0046] The present invention mainly provides a leaflet cutting device, which has a distal cutting part and a proximal operating part, wherein the distal cutting part integrates the functions of clamping, cutting and conveying. Specifically, the distal cutting part includes a main body, a moving part, a cutting head and a clamping arm, wherein the cutting head has a double-sided blade, which can adapt to the needs of different cutting directions and has an electric cutting function. During transportation, the cutting head is a hidden structure, which improves the safety of the device during intravascular delivery; the clamping arm is in a closed state during transportation, at which time the clamping arm and the main body form a roughly continuous cylindrical surface, reducing the risk of damage to the blood vessel wall. After the clamping arm is opened, its inner side has a barb structure, which improves the fixation effect on leaflets of different shapes. Furthermore, the proximal operating part includes a clamping arm opening and closing mechanism and a cutting head moving mechanism. The clamping arm opening and closing mechanism allows the operator to accurately control the opening and closing angle and speed of the clamping arm, while the cutting head moving mechanism can achieve precise control of the cutting depth, position and method.

[0047] The present invention further provides a leaflet cutting system, which, in addition to the above-mentioned leaflet cutting device, is further provided with a bending control and delivery device. The bending control and delivery device includes an outer sheath and a bending control handle. By operating the bending control handle, the bending angle of the distal end of the outer sheath can be adjusted, thereby improving the system's navigation capability in complex vascular pathways. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0049] Figure 1 This is a schematic structural diagram of a leaflet cutting device according to an embodiment of the present invention disclosed in Example 1;

[0050] Figure 2 This is a schematic diagram of the distal cutting portion in an embodiment disclosed in Example 1 of the present invention when the clamping arms are closed;

[0051] Figure 3 This is a schematic diagram of the distal cutting portion in an embodiment disclosed in Example 1 of the present invention when the clamping arms are open;

[0052] Figure 4 This is a cross-sectional view of an embodiment of the present invention disclosed in Example 1 when the cutter head body is at the far end of the cutter head guide groove;

[0053] Figure 5 This is a cross-sectional view of the cutter head body at the proximal end of the cutter head guide groove in an embodiment disclosed in Example 1 of the present invention;

[0054] Figure 6This is a schematic structural diagram of a cutter head in an embodiment disclosed in Example 1 of the present invention;

[0055] Figure 7 This is a schematic structural diagram of a clamping arm in an implementation manner disclosed in Example 1 of the present invention;

[0056] Figure 8 A diagram showing the force state between the clamp arm and the moving part when the clamp arm is opened in an embodiment disclosed in Example 1 of the present invention;

[0057] Figure 9 A diagram showing the force state between the clamp arm and the moving part when the clamp arm is closed in an embodiment disclosed in Example 1 of the present invention;

[0058] Figure 10 This is a cross-sectional view of a catheter portion and a proximal operating portion in an embodiment disclosed in Example 1 of the present invention;

[0059] Figure 11 A schematic diagram of a clamp arm opening and closing mechanism according to an embodiment of the present invention disclosed in Example 1;

[0060] Figure 12 This is a schematic diagram of a tool head moving mechanism in an implementation manner disclosed in Example 1 of the present invention;

[0061] Figure 13 A cross-sectional view of a threaded rotating member according to an embodiment of the present invention disclosed in Example 1;

[0062] Figure 14 This is a schematic diagram of a threaded moving part in an implementation manner disclosed in Example 1 of the present invention;

[0063] Figure 15 A schematic diagram of a clamp arm opening and closing mechanism according to an embodiment of the present invention disclosed in Example 1;

[0064] Figure 16 This is a structural diagram of a leaflet cutting system according to an embodiment of the present invention disclosed in Example 2;

[0065] Figure 17 This is a schematic structural diagram of a sheath locking knob in an embodiment of the present invention disclosed in Example 2;

[0066] Figure 18 This is a structural diagram of a knob body in an implementation manner disclosed in Example 2 of the present invention;

[0067] Figure 19 This is a schematic structural diagram of a clamping member in an embodiment disclosed in Example 2 of the present invention;

[0068] Figure 20 This is a schematic diagram of the operation of the leaflet cutting system in the heart in an implementation manner disclosed in Example 2 of the present invention.

[0069] Description of reference numerals:

[0070] Distal cutting portion 10, guide portion 11, main body portion 12, blade guide groove 121, blade hidden cavity 1211, moving part 13, notch 131, blade 14, outer blade 141, inner blade 142, control rod 143, clamping arm 15, first boss 151, barb structure 152, catheter portion 20, middle sheath 21, inner sheath 22, first lumen 221, second lumen 222, proximal operating portion 30, middle sheath fixing Part 31, second boss 311, middle sheath rotating part 32, slide groove 321, inner sheath fixing part 33, threaded rotating part 34, threaded moving part 35, power interface 351, scale mark 352, bending control conveying device 40, bending control handle 41, outer sheath tube 42, middle sheath locking knob 43, knob body 431, knob groove 4311, clamping part 432, clamping groove 4321, guide wire 50, aortic arch 60, aortic valve 70. DETAILED DESCRIPTION

[0071] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0072] In the description of the present invention, it should be noted that, unless otherwise expressly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. In addition, in the description of this application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance. The "proximal end" mentioned herein refers to the end along the length direction of the leaflet cutting device that is close to the operator, and the "distal end" refers to the end along the length direction of the leaflet cutting device that is away from the operator.

[0073] Those skilled in the art will appreciate that, in order to achieve their respective functions while meeting the requirements of surgical procedures, the specific shapes, sizes, angles, etc. of each structure can be adaptively adjusted. Obviously, the described embodiments are only a portion of the embodiments of the present invention, not all of them. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0074] Example 1

[0075] This embodiment provides a leaflet cutting device, which is preferably suitable for transcatheter aortic valvulectomy, and is particularly suitable for treating lesions such as aortic valve stenosis or calcification before implanting an artificial valve, so as to improve coronary hemodynamics and reduce the risk of coronary obstruction.

[0076] refer to Figure 1 — Figure 15 The leaflet cutting device includes a distal cutting part 10, a catheter part 20 and a proximal operating part 30 from the distal end to the proximal end, wherein the distal cutting part 10 includes a main body, a moving part 13, a cutting head 14 and a clamping arm 15, the catheter part 20 includes a middle sheath 21 and an inner sheath 22, and the proximal operating part 30 includes an operating handle, a clamping arm opening and closing mechanism and a cutting head moving mechanism.

[0077] like Figure 2 、 Figure 3 In some embodiments, the main body includes a main body portion 12 and a guide portion 11 connected thereto.

[0078] In some embodiments, the main body portion 12 is configured as a dual-cavity structure, including a hollow inner cavity and a blade guide groove 121 that are isolated from each other, both of which extend axially along the main body portion 12, wherein the hollow inner cavity is provided with a distal opening and a proximal opening for passing the guide wire 50, and the blade guide groove 121 is open on the side to accommodate the axial movement of the blade 14. During the movement, the blade 14 is exposed to the open area of ​​the blade guide groove 121 to achieve cutting of the leaflet.

[0079] like Figure 4 、 Figure 5 In some embodiments, the blade guide groove 121 further includes a guide cavity and a blade hidden cavity 1211, wherein the guide cavity is provided in the middle of the blade guide groove 121 and is an open area on the side of the blade guide groove 121. When the blade 14 moves therein, the cutting operation of the leaflet can be realized. Furthermore, a blade hidden cavity 1211 is provided at both the proximal and distal ends of the blade guide groove 121, and at least the length of the blade hidden cavity 1211 at the distal end is not less than that of the blade 1 4, the height of the blade hidden cavity 1211 is greater than the height of the blade of the blade 14. During the transportation of the blade 14, the blade is located in the blade hidden cavity 1211 at the distal end. When the blade 14 moves to the proximal end of the blade guide groove 121, the blade is located in the blade hidden cavity 1211 provided at the proximal end. By setting the blade 14 as a hidden structure, the risk of damaging tissue due to the exposure of the blade 14 during the transportation of the distal cutting part 10 can be effectively reduced.

[0080] In some embodiments, the guide portion 11 is roughly conical and is fixedly connected to the distal opening of the hollow inner cavity, that is, the guide portion 11 is the distal end of the entire leaflet cutting device; an axially through cavity is provided in the guide portion 11, and the cavity is connected to the hollow inner cavity of the main body portion 12, for passing the guide wire 50. Specifically, the guide wire 50 can play a positioning role during the operation. When the leaflet cutting is completed, the leaflet cutting device is withdrawn from the body along the guide wire 50, and then other instruments can be inserted to carry out subsequent surgical operations.

[0081] In some embodiments, the guide portion 11 is made of a soft material, while the main body portion 12 is made of a rigid material; the flexible guide portion 11 can, on the one hand, reduce the risk of irritation and potential damage to the blood vessel wall, and on the other hand, can better adapt to the curvature and changes of the blood vessel and improve the passability of the device; and the rigid main body portion 12 can provide sufficient rigidity and strength for the entire distal cutting portion 10 to ensure the stability of the operation and the accuracy of clamping and cutting the leaflets.

[0082] In some embodiments, the guide portion 11 is injection molded from a soft material, and the main body portion 12 is injection molded from an insulating, high-hardness material. The insulating main body portion 12 can prevent current leakage, especially when using the electric cutting function of the blade 14, and can protect the safety of the patient and the operator.

[0083] like Figure 6 In some embodiments, the cutting head 14 is arranged inside the main body and can move axially between the distal end and the proximal end of the cutting head guide groove 121. The structure of the cutting head 14 includes a cutting head body and a control rod 143. The control rod 143 is used to control the axial movement of the cutting head body. The cutting head body is provided with bilateral blades for cutting the leaflets to achieve different cutting methods of the leaflets during the movement.

[0084] In some embodiments, the control rod 143 is made of a conductive material, and at least one blade of the blade body is also made of a conductive material. The control rod 143 is connected to the proximal end of the blade body and is electrically conductive. When not powered, the control rod 143 can only control the axial movement of the blade body within the blade guide groove 121 to achieve physical cutting of the valve leaflets. When powered, the blades made of one or both conductive materials can achieve electrical cutting of the valve leaflets, which is particularly suitable for calcified valve leaflets. Specifically, physical cutting or electrical cutting can be selected according to clinical needs.

[0085] In some embodiments, the outer surface of the control rod 143 is further provided with an insulating coating to prevent accidental electric shock when the blade body is performing electric cutting.

[0086] In some embodiments, when only one side of the blade is made of a conductive material, the other side of the blade may be made of a non-conductive material or coated with an insulating layer. In this case, the blade head body is configured as a monopolar electric knife or a high-frequency electric knife.

[0087] In some embodiments, when the outer blade 141 and the inner blade 142 of the blade body are both made of conductive materials, the blade body is configured as a bipolar electric knife or a high-frequency electric knife. It should be noted that when the blade body is configured as a bipolar electric knife, a gap needs to be provided between the outer blade 141 and the inner blade 142, and the current generated between the two is mainly used to coagulate fine tissues.

[0088] In some embodiments, in order to achieve the hidden structure of the blade 14 and ensure the smooth movement of the blade 14, the height of the blade body is less than the radius of the main body; further, the bilateral blades are obliquely arranged on the blade body, the outer blades 141 of the bilateral blades are facing the distal end, and the inner blades 142 of the bilateral blades are facing the proximal end. When the starting position of the blade 14 is at the distal end of the blade guide groove 121, after capturing the leaflet, the blade 14 is pulled back toward the proximal end, and the inner blade 142 can start cutting from the root of the leaflet; when the starting position of the blade 14 is at the proximal end of the blade guide groove 121, after capturing the leaflet, the blade 14 is pushed toward the distal end, and the outer blade 141 can start cutting from the corresponding edge of the leaflet, thereby achieving partial cutting of the leaflet.

[0089] In some embodiments, the outer blade 141 is set at a first inclination angle relative to the axis of the blade body, and the first inclination angle causes the cutting edge of the outer blade 141 to tilt outward from the axis of the blade body; the inner blade 142 is set at a second inclination angle relative to the axis of the blade body, and the second inclination angle causes the cutting edge of the inner blade 142 to tilt outward from the axis of the blade body; the first inclination angle and the second inclination angle can be the same or different, and can be adjusted and selected according to the valve disease condition, and are not specifically limited in this embodiment.

[0090] Specifically, by tilting the bilateral blades, on the one hand, the contact area between the blades and the leaflet tissue can be increased, making cutting more efficient; on the other hand, the pressure during cutting can be reduced, creating an effect similar to "sliding cutting", making cutting smoother and reducing tissue tearing; by adjusting the first tilt angle and the second tilt angle, the bilateral blades can be adapted to the cutting requirements of different directions and positions respectively, and can also adapt to leaflet tissues of different thicknesses and hardnesses.

[0091] refer to Figure 2 、 Figure 3 、 Figure 7In some embodiments, the proximal end of the clamping arm 15 is rotatably connected to the main body, and the distal end thereof is used to clamp and fix the leaflet. The movable member 13 is cylindrically sleeved on the proximal end of the main body and is slidably connected to the clamping arm 15. The movable member 13 can move axially relative to the main body to drive the clamping arm 15 to rotate around the main body to realize the opening and closing of the clamping arm 15. When the clamping arm 15 closes and clamps the leaflet, the axial movement of the cutter head 14 is used to achieve cutting of the fixed leaflet.

[0092] In some embodiments, the clamp arm 15 is connected to the main body by a pivot connection structure such as rivets to form a rotatable hinge point, and a first boss 151 is provided on the proximal side of the hinge point, and the first boss 151 is slidingly connected to the movable member 13; the outer peripheral surface of the movable member 13 is provided with an inclined notch 131, and the notch 131 matches the first boss 151, and the first boss 151 can slide smoothly along the notch 131; the axial movement of the movable member 13 can drive the clamp arm 15 to rotate around the hinge point to achieve opening and closing. When the clamp arm 15 is in a closed state, the outer surface of the clamp arm 15 and the outer contour of the hidden cavity are located on the same cylindrical surface, which minimizes the stimulation and damage to the blood vessel wall during intravascular delivery.

[0093] In some embodiments, the length of the slot 131 determines the maximum opening and closing angle of the clamp arm 15. By adjusting the length of the slot 131, specific opening and closing angles can be designed for leaflets of different sizes to improve adaptability; and the inclination angle of the slot 131 matches the opening and closing speed of the clamp arm 15. A larger inclination angle will result in a faster opening and closing speed, while a smaller angle will make the opening and closing slower and more controllable. By adjusting the inclination angle of the slot 131, the opening and closing speed of the clamp arm 15 can be controlled to avoid sudden impact on fragile tissues; in this embodiment, the length or inclination angle of the slot 131 is no longer specifically limited, and those skilled in the art can make adjustments according to the actual needs of different patients.

[0094] In some embodiments, the position of the notch 131 also determines the opening and closing force of the clamping arm 15; Figure 8 When the leaflet cutting device is opened, the first boss 151 of the clamping arm 15 is subjected to the horizontal pulling force FA of the moving part 13. FA is decomposed into the force FA1 along the notch 131 and the force FA2 perpendicular to the notch 131. L1 is the distance from the point of action of the force to the rotation axis. According to the torque formula M=F*L, the longer the force arm, the smaller the force on the clamping arm 15, and the easier it is to open and close. Figure 9When the leaflet cutting device is closed, the first boss 151 of the clamping arm 15 is subjected to a horizontal thrust FB from the movable member 13. FB is decomposed into a force FB1 along the notch 131 and a force FB2 perpendicular to the notch 131. L2 is the distance from the point of force application to the axis of rotation. According to the torque formula M = F * L, a short moment arm allows the clamping arm 15 to exert greater force on the main member, resulting in better clamping force. In this embodiment, the specific location of the notch 131 is not limited; those skilled in the art can adjust it based on the actual needs of different patients.

[0095] In some embodiments, a developing ring is provided on the outer side of the clamping arm 15 for observing the position of the leaflet cutting device under surgical angiography, so as to facilitate the operator to make corresponding adjustments.

[0096] like Figure 7 In some embodiments, the inner side of the clamp arm 15 is provided with a barb structure 152. When the clamp arm 15 is closed, the leaflet is located between the clamp arm 15 and the main body. The barb structure 152 can fix the position of the leaflet, preventing the leaflet from sliding or shifting during the cutting process, thereby facilitating subsequent cutting operations. Optionally, the barb structure 152 includes but is not limited to a tooth shape, a cone shape, or a rake shape, and the barb structures 152 on both sides of the clamp arm 15 can be configured in different shapes and / or quantities to facilitate a better fit between the clamp arm 15 and the main body.

[0097] Specifically, barb structures 152 of different shapes and sizes can adapt to leaflet tissues of varying thickness, hardness, and texture. For example, a tooth-like structure may be more suitable for thin leaflets, while a stronger conical or rake-like structure may be required for thicker or calcified leaflets. By distributing the barbs in different numbers, pressure distribution can be optimized to avoid localized excessive pressure that can cause tissue tearing and other damage. By selecting the appropriate barb shape, size, and number, sufficient fixing force can be provided while minimizing damage to the leaflet tissue. This is not specifically limited in this embodiment.

[0098] In some embodiments, the clamping arm 15 and the moving member 13 are both made of insulating materials to prevent accidental electric shock when the cutting head 14 performs electric cutting, while reducing thermal damage to surrounding areas caused by heat generated during the electric cutting process.

[0099] In some embodiments, when the clamp arm 15 is closed, the front view of the entire distal cutting portion 10 is circular, with a maximum diameter of no more than 6 mm, to facilitate delivery in the artery; further, the outer surface of the entire distal cutting portion 10 is a roughly continuous cylinder without other protruding structures, to avoid damage to blood vessels or other tissues during delivery.

[0100] In some embodiments, the distal end of the middle sheath 21 is connected to the movable part 13, and the distal end of the inner sheath 22 is connected to the main body. The middle sheath 21 is sleeved on the outside of the inner sheath 22. When the leaflet is cut, the inner sheath 22 is relatively fixed, and the middle sheath 21 can move axially to drive the movable part 13 to move, and finally realize the opening and closing of the clamping arm 15.

[0101] like Figure 10 In some embodiments, the proximal operating portion 30 includes an operating handle, and the proximal ends of the middle sheath tube 21 and the inner sheath tube 22 are both inserted into the operating handle. The operating handle also includes a clamping arm opening and closing mechanism and a blade moving mechanism, wherein the clamping arm opening and closing mechanism is used to control the opening and closing of the clamping arm 15, and the blade moving mechanism is used to control the movement of the blade head 14.

[0102] like Figure 11 In some embodiments, an inner sheath fixing part 31 is provided at the distal end of the operating handle, the middle part of the inner sheath fixing part 31 is passed through, the proximal end of the inner sheath tube 21 is passed through the inner sheath fixing part 31 and is fixedly connected thereto, and a second boss 311 is provided on the outer side of the inner sheath fixing part 31; the clamping arm opening and closing mechanism includes an inner sheath rotating part 32, the inner sheath rotating part 32 is rotatably provided on the outer side of the distal end of the operating handle, and the second boss 311 is slidably matched with the inner sheath rotating part 32. When the inner sheath rotating part 32 is rotated, the inner sheath fixing part 31 can be controlled to move axially relative to the operating handle, and the inner sheath tube 21 can be driven to move axially, and finally the clamping arm 15 is driven to open and close by the axial movement of the moving part 13 relative to the main part.

[0103] In some embodiments, the middle sheath rotating member 32 includes a rotating outer shell and a sliding block fixed on the inner side of the rotating outer shell. The sliding block is provided with a torsion-shaped sliding groove 321. The second boss 311 is slidably set in the sliding groove 321 and can move smoothly therein. When the rotating outer shell is rotated, the second boss 311 can move in the sliding groove 321. By converting the rotational motion into axial motion, the axial movement of the middle sheath fixing member 31 can be driven, thereby controlling the opening and closing degree of the clamping arm 15.

[0104] Specifically, by adjusting the pitch and length of the slide groove 321, the opening and closing angle and opening and closing rate of the clamp arm 15 can be controlled, so as to find the best balance between precise control and rapid operation, reduce the possibility of sudden opening and closing of the clamp arm 15, and avoid accidental damage to the blood vessel wall, valve leaflets or other tissues.

[0105] In some embodiments, limiting grooves are respectively provided at both ends of the slide groove 321, and the limiting grooves are used to limit the opening and closing angles of the clamp arm 15 or maintain the closed state of the clamp arm 15; specifically, when the clamp arm 15 opens and closes, the slider reaches the limiting groove, and the opening and closing angles of the clamp arm 15 reach the maximum and remain fixed, reducing the risk of damage to the instrument caused by excessive rotation by the operator. At the same time, the limiting groove can also limit the opening and closing angles of the clamp arm 15, avoiding damage to the blood vessel wall or other biological tissues due to excessive opening and closing during the opening and closing process of the clamp arm 15; when the clamp arm 15 is closed, the slider reaches the limiting groove on the other side, and the clamp arm 15 remains tightly closed, stably clamping the leaflet for subsequent cutting operations.

[0106] like Figure 12 — Figure 15 In some embodiments, an inner sheath fixing part 33 is provided at the proximal end of the operating handle, the inner sheath fixing part 33 and the operating handle are relatively stationary, and the proximal end of the inner sheath tube 22 is fixedly connected to the inner sheath fixing part 33; specifically, the inner sheath tube 22 is configured as a double-lumen tube, including a first lumen 221 and a second lumen 222, the first lumen 221 is used to pass the guide wire 50, and the second lumen 222 is used to pass the control rod 143 of the blade head 14, the first lumen 221 and the second lumen 222 are separated at the proximal end, and the separated first lumen 221 and the second lumen 222 are both passed through the inner sheath fixing part 33 and fixedly connected to it.

[0107] In some embodiments, the cutter head moving mechanism includes a threaded moving part 35 and a threaded rotating part 34. The threaded moving part 35 is assembled inside the proximal end of the operating handle, and its surface is provided with an external thread; the threaded rotating part 34 is rotatably assembled on the outside of the proximal end of the operating handle, and the threaded rotating part 34 is provided with an internal thread matching the threaded moving part 35; the proximal end of the first cavity 221 of the inner sheath tube 22 is penetrated and arranged in the threaded rotating part 34, and the proximal end of the second cavity 222 is connected to the threaded moving part 35, and the control rod 143 passes through the second cavity 222 and is fixedly connected to the threaded moving part 35. When the threaded rotating part 34 is rotated, the threaded moving part 35 is driven to move axially, and then the control rod 143 is driven to move, and finally the movement of the cutter head 14 is realized to cut the leaflet.

[0108] In some embodiments, the proximal end of the inner sheath fixing member 33 further extends into the interior of the threaded moving member 35 to limit the circumferential rotation of the threaded moving member 35 and ensure that it can only move axially.

[0109] In some embodiments, the operating handle is further provided with a power interface 351 , which is connected to the second cavity 222 and is in communication with the control rod 143 . When the operating handle is connected to an external power source, the blade head 14 can perform electric cutting operations.

[0110] refer to Figure 14 、 Figure 15In some embodiments, a scale mark 352 is further provided at the proximal end of the threaded moving member 35 , and the displacement of the cutter head 14 can be determined by the scale indicated by the threaded moving member 35 .

[0111] refer to Figure 20 In this embodiment, after the distal cutting portion 10 of the leaflet cutting device reaches the aortic valve 70 along the aortic arch 60, the clamping arms 15 can be controlled to open and close by rotating the middle sheath rotating member 32 to clamp and secure the aortic valve 70. Subsequently, the threaded rotating member 34 can be rotated to control the cutting head 14 to move from the proximal end to the distal end to cut the aortic valve 70, or from the distal end to the proximal end to cut the aortic valve 70. When the power interface 351 of the operating handle is connected to an external power source, the cutting head 14 can also be electrically cut. After the leaflet cutting is completed, the leaflet cutting device is withdrawn from the human body along the guide wire 50 to facilitate subsequent surgical procedures.

[0112] Example 2

[0113] refer to Figure 16 — Figure 20 This embodiment provides a leaflet cutting system, including the leaflet cutting device as described in Example 1, and also including a bending control delivery device 40; the various technical features already included in Example 1 are naturally inherited in this embodiment and will not be repeated.

[0114] like Figure 16 In some embodiments, the bending control delivery device 40 includes an outer sheath 42, a bending control handle 41 and a middle sheath locking knob 43, wherein the lumen of the outer sheath 42 is used to pass through the middle sheath 21, and the proximal end of the outer sheath 42 is passed through the bending control handle 41. The bending control handle 41 is used to adjust the bending angle of the outer sheath 42 to improve the navigation ability of the system in complex vascular pathways; the middle sheath locking knob 43 is arranged at the proximal end of the bending control handle 41, and can be interference fit with the middle sheath 21 to lock it.

[0115] Specifically, the structure of the bending control handle 41 and the outer sheath 42 can be selected from any structure disclosed in any embodiment in the prior art, and is not specifically limited here.

[0116] like Figure 17 — Figure 19In some embodiments, the middle sheath locking knob 43 includes a knob body 431 and a clamping member 432. The knob body 431 is threadedly engaged with the clamping member 432. The middle part of the knob body 431 has an empty slot, which is defined as a knob slot 4311. The knob slot 4311 is configured as a wide upper and narrow lower structure, which matches the proximal structure of the clamping member 432; the distal end of the clamping member 432 is threadedly engaged with the bending control handle 41, and the proximal structure of the clamping member 432 is configured as an open structure with an empty slot, which is defined as a clamping slot 4321, which can produce deformation. During use, the clamping groove 4321 inside the clamping piece 432 can pass through the middle sheath tube 21, and the knob body 431 cooperates with the clamping piece 432 through threads. At this time, the knob groove 4311 presses the clamping groove 4321, and the clamping groove 4321 is deformed to clamp the middle sheath tube 21 inward, thereby locking the position of the middle sheath tube 21 to prevent it from accidentally moving during transportation, thereby reducing surgical risks.

[0117] like Figure 20 When the leaflet cutting system in this embodiment is in use, the bend control delivery device 40 and the leaflet cutting device arrive at the target position in the patient's heart together with the guide wire 50. The bend control delivery device 40 can make the leaflet cutting device more convenient to pass through large curved blood vessels such as the aortic arch 60. When the distal cutting part 10 of the leaflet cutting device reaches the aortic valve 70, the middle sheath locking knob 43 is rotated so that it no longer moves the middle sheath tube 21, so as to continue the subsequent leaflet clamping and cutting operations. The specific method is the same as that of the above-mentioned embodiment 1 and will not be repeated here.

[0118] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims

1. A leaflet cutting device, characterized in that: The distal cutting part includes a main body, a cutting head, a clamping arm and a moving part: The main body comprises a main body portion and a guide portion, wherein the main body portion is provided with a hollow inner cavity and a blade guide groove, wherein the hollow inner cavity is provided with a distal opening and a proximal opening for passing a guide wire; the blade guide groove is isolated from the hollow inner cavity and is provided to accommodate the axial movement of the blade; the guide portion is connected to the distal opening and communicates with the hollow inner cavity; The cutter head is arranged inside the main body and can move axially between the distal end and the proximal end of the main body, and the cutter head is provided with double-sided blades for cutting the leaflets; the cutter head comprises a cutter head body and a control rod connected to the proximal end thereof, the height of the cutter head body is less than the radius of the main body, the double-sided blades are obliquely arranged on the cutter head body, the outer blades of the double-sided blades face the distal end, and the inner blades of the double-sided blades face the proximal end; the control rod is used to control the axial movement of the cutter head body in the cutter head guide groove; The proximal end of the clamp arm is rotatably connected to the main body, and the distal end thereof is used to clamp and fix the leaflet; the clamp arm is connected to the main body via a pivot connection structure to form a rotatable hinge point; a first boss is provided on the proximal side of the hinge point, and the first boss is slidably connected to the moving part; when the clamp arm is in a closed state, the outer surface of the clamp arm and the outer contours of the two ends of the blade guide groove are located on the same cylindrical surface; The inner side of the clamp arm is also provided with a barb structure, and the barb structure is used to fix the leaflet; The movable member is slidably connected to the clamp arm, and the movable member can move axially relative to the main body, and is used to drive the clamp arm to rotate around the hinge point between the main body and the clamp arm to realize the opening and closing of the clamp arm; When the clamp arms are closed and the leaflets are fixed, the axial movement of the cutter head realizes cutting of the fixed leaflets.

2. The leaflet cutting device according to claim 1, characterized in that: The main body portion comprises a rigid material; the guide portion comprises a soft material.

3. The leaflet cutting device according to claim 1, characterized in that: The control rod comprises a conductive material and is electrically connected to the cutter head body. At least one blade of the cutter head body comprises a conductive material and is used to electrically cut the leaflet tissue when powered on. The main body portion and the guide portion both include electrically insulating materials.

4. The leaflet cutting device according to claim 3, characterized in that: The cutter head guide groove comprises: - a blade hidden cavity, wherein a blade hidden cavity is provided at both the proximal end and the distal end of the blade guide groove, the length of the blade hidden cavity is not less than the length of the blade body, and the height of the blade hidden cavity is greater than the height of the blade body; - A guide cavity is provided in the middle of the cutter head guide groove, and the side of the guide cavity is open. When the cutter head body moves in the guide cavity, the cutting operation on the leaflet is realized.

5. The leaflet cutting device according to claim 4, characterized in that: A developing ring is provided on the outer side of the clamping arm.

6. The leaflet cutting device according to claim 1, characterized in that: The movable member is cylindrically sleeved on the outer side of the proximal end of the main member and can move axially along the main member; The outer peripheral surface of the movable part is provided with a notch, which matches the first boss and allows the first boss to slide smoothly therein; the notch is arranged obliquely, and the length of the notch matches the maximum opening and closing angle of the clamping arm.

7. The leaflet cutting device according to any one of claims 1 to 6, characterized in that: It also includes a proximal operating part and a catheter part, wherein both ends of the catheter part are connected to the distal cutting part and the proximal operating part respectively; The catheter portion includes an inner sheath tube and a middle sheath tube, wherein the distal end of the middle sheath tube is connected to the moving member, and the distal end of the inner sheath tube is connected to the main body member; The proximal operating part includes an operating handle, in which a clamp arm opening and closing mechanism and a cutter head moving mechanism are provided. The clamp arm opening and closing mechanism is used to control the opening and closing of the clamp arm, and the cutter head moving mechanism is used to control the movement of the cutter head.

8. The leaflet cutting device according to claim 7, characterized in that: The distal end of the operating handle is provided with a middle sheath fixing piece, the middle portion of the middle sheath fixing piece is passed through, and the proximal end of the middle sheath tube is passed through the middle sheath fixing piece and fixedly connected thereto; The clamp arm opening and closing mechanism can control the axial movement of the middle sheath fixing member relative to the operating handle, and drive the axial movement of the middle sheath tube, and finally drive the clamp arm to open and close through the axial movement of the moving member.

9. The leaflet cutting device according to claim 8, characterized in that: A second boss is provided on the outer side of the middle sheath fixing piece, and the clamp arm opening and closing mechanism includes a middle sheath rotating piece, which is rotatably arranged on the outer side of the distal end of the operating handle, and a sliding groove is provided on the inner side of the middle sheath rotating piece for twisting, and the second boss is arranged in the sliding groove. The rotation of the middle sheath rotating piece can make the second boss move in the sliding groove, thereby driving the axial movement of the middle sheath fixing piece.

10. The leaflet cutting device according to claim 9, characterized in that: Limiting grooves are respectively provided at both ends of the sliding slot, and the limiting grooves are used to limit the opening and closing angles of the clamping arm or maintain the closed state of the clamping arm.

11. The leaflet cutting device according to claim 7, characterized in that: The inner sheath is configured as a double-lumen tube, including a first lumen and a second lumen, wherein the first lumen and the second lumen are separated at the proximal end, the first lumen is used for passing a guide wire, and the second lumen is used for passing a control rod of the blade head; An inner sheath fixing piece is fixedly connected to the operating handle, and the separated first lumen and second lumen are both passed through the inner sheath fixing piece and fixedly connected thereto.

12. The leaflet cutting device according to claim 11, characterized in that: The cutter head moving mechanism is arranged at the proximal end of the operating handle and includes a threaded moving part and a threaded rotating part; The proximal end of the first cavity is disposed through the threaded rotating member. The proximal end of the second cavity is connected to the threaded moving member, and the control rod passes through the second cavity and is fixedly connected to the threaded moving member.

13. The leaflet cutting device according to claim 12, characterized in that: The threaded moving member is assembled inside the proximal end of the operating handle, and has an external thread on its surface; The threaded rotating member is rotatably assembled on the proximal end of the operating handle, and the threaded rotating member is provided with an internal thread matching the threaded moving member; the rotation of the threaded rotating member is used to drive the axial movement of the threaded moving member, and then drive the movement of the control rod, and finally realize the axial movement of the cutter head.

14. A leaflet cutting system, characterized in that: It comprises a leaflet cutting device as described in any one of claims 7 to 13, and also comprises a bending control delivery device.

15. The leaflet cutting system according to claim 14, wherein: The bending control conveying device includes an outer sheath and a bending control handle. The lumen of the outer sheath is used to pass the middle sheath. The proximal end of the outer sheath is passed through the bending control handle. The bending control handle is used to adjust the bending angle of the outer sheath.

16. The leaflet cutting system according to claim 15, characterized in that: The bending control delivery device also includes a middle sheath locking knob, which is arranged at the proximal end of the bending control handle and can be interference fit with the middle sheath tube to lock it.

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