Valve leaflet cutting device and system

Abstract

The invention relates to a valve leaflet cutting device and system. The valve leaflet cutting device at least comprises a far-end cutting part, and the far-end cutting part comprises a main body piece, a tool bit, a clamping arm and a moving piece; the tool bit is arranged in the main body part and can axially move between the far end and the near end of the main body part, and the tool bit is provided with double-side cutting edges used for cutting valve leaflets; the near end of the clamping arm is rotatably connected with the main body piece, and the far end is used for clamping and fixing a valve leaflet; the moving part is in sliding connection with the clamping arm, can axially move relative to the main body part and is used for driving the clamping arm to rotate around the main body part to realize opening and closing of the clamping arm; when the clamping arms are closed and the valve leaflet is fixed, the fixed valve leaflet is cut through the axial movement of the tool bit.

Description

Technical Field

[0001] The present invention relates to the field of medical instruments 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 brought innovation to the treatment of aortic stenosis. However, in surgeries such as TAVR, ViV-TAVR (valve-in-valve TAVR) and Redo-TAVR (repeat TAVR), the risk of coronary artery obstruction is a key problem, which limits the application of these technologies in more 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 guide wire to cut and tear the degenerated and thickened autologous valve leaflets or the failed 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, although the BASILICA technique has shown potential in preventing coronary artery obstruction, it still has some shortcomings, especially in the existing technology, there is a lack of devices specifically designed for leaflet cutting, which limits the further development and application of related technologies. Summary of the invention

[0005] The invention discloses a leaflet cutting device and a 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, wherein the distal cutting portion comprises:

[0008] -Main body;

[0009] - a cutting head, which 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 double-sided cutting edges for cutting the valve 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 part, which is slidably connected to the clamp arm, and can move axially relative to the main part, and is used to drive the clamp arm to rotate around the main part to realize the opening and closing of the clamp arm;

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

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

[0014] - a main body part, provided with a hollow inner cavity and a blade guide groove; the hollow inner cavity is provided with a distal opening and a proximal opening for passing a guide wire; the blade guide groove and the hollow inner cavity are isolated from each other and are used to accommodate the 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, 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;

[0019] - A control rod connected to the proximal end of the cutter head body and used for controlling 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 cutter head body. At least one side of the cutting edge of the cutter head body includes a conductive material for achieving electrical cutting of the leaflet tissue when power is supplied. The main body portion and the guide portion both include electrically insulating materials.

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

[0022] - a blade hidden cavity, a blade hidden cavity is provided at 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;

[0023] - A guide cavity is arranged in the middle of the guide groove of the cutter head, and the side of the guide cavity is opened. 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 clamp arm is connected to the main body by 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; the axial movement of the moving part drives the clamp arm to rotate around the hinge point to achieve opening and closing, and when the clamp arm is in a closed state, the outer surface of the clamp 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 valve leaflet; a developing ring is provided on the outer side of the clamp arm.

[0026] As a preferred technical solution, the moving member is sleeved on the proximal outer side of the main member in a cylindrical shape 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 so that the first boss can slide smoothly therein; the notch is inclined, 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, 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 comprises an operating handle, in which a clamp arm opening and closing mechanism and a cutter head moving mechanism are arranged. 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.

[0031] As a preferred technical solution, a middle sheath fixing piece is provided at the distal end of the operating handle, the middle part 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 middle sheath tube to move axially, 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 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 slide groove is twistedly arranged on the inner side of the middle sheath rotating piece, and the second boss is arranged in the slide groove. The rotation of the middle sheath rotating piece can make the second boss move in the slide groove, thereby driving the axial movement of the middle sheath fixing piece.

[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 are separated and arranged at the proximal end, the first lumen is used for passing the guide wire, and the second lumen is used for passing the control rod of the blade head;

[0036] An inner sheath fixing piece is fixedly connected inside the operating handle, and the separated first cavity and the second cavity are both penetrated 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 part is assembled inside the proximal end of the operating handle, and its surface is provided with external threads;

[0041] The threaded rotating member can be 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 leaflet cutting device mentioned above, and also comprising a bending control delivery device.

[0043] As a preferred 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 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 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.

[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 cutter head and a clamp arm, wherein the cutter head has a double-sided blade, which can adapt to the needs of different cutting directions and has an electric cutting function. During conveying, the cutter head is a hidden structure, which improves the safety of the device during intravascular delivery; the clamp arm is in a closed state during conveying, and the clamp arm and the main body form a roughly continuous cylindrical surface at this time, reducing the risk of damage to the blood vessel wall. After the clamp arm is opened, the inner side thereof has a barb structure, which improves the fixing effect of leaflets of different shapes. Furthermore, the proximal operating part includes a clamp arm opening and closing mechanism and a cutter head moving mechanism. The clamp arm opening and closing mechanism allows the operator to accurately control the opening and closing angle and speed of the clamp arm, and the cutter head moving mechanism can achieve accurate 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, which includes an outer sheath and a bending control handle. By operating the bending control handle, the bending control angle of the distal end of the outer sheath can be adjusted, thereby improving the navigation capability of the system 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 explain the present invention and do not constitute improper limitations on the present invention. In the drawings:

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

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

[0051] Figure 3 A schematic diagram of a distal cutting portion when the clamp arm is opened in an implementation manner disclosed in Example 1 of the present invention;

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

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

[0054] Figure 6A schematic diagram of the structure of a cutter head in an implementation manner disclosed in Example 1 of the present invention;

[0055] Figure 7 This is a schematic diagram of the structure of a clamp 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 implementation method disclosed in Example 1 of the present invention;

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

[0058] Fig.10 A cross-sectional view of a catheter portion and a proximal operating portion in an implementation manner disclosed in Example 1 of the present invention;

[0059] Fig.11 A schematic diagram of a clamp arm opening and closing mechanism in an implementation manner disclosed in Example 1 of the present invention;

[0060] Fig.12 A schematic diagram of a tool head moving mechanism in an implementation manner disclosed in Example 1 of the present invention;

[0061] Fig.13 A cross-sectional view of a threaded rotating member in an implementation manner disclosed in Example 1 of the present invention;

[0062] Fig.14 A schematic diagram of a threaded moving part in an implementation method disclosed in Example 1 of the present invention;

[0063] Fig.15 A schematic diagram of a clamp arm opening and closing mechanism in an implementation manner disclosed in Example 1 of the present invention;

[0064] Fig.16 This is a schematic structural diagram of a leaflet cutting system in an implementation manner disclosed in Example 2 of the present invention;

[0065] Fig.17 This is a schematic diagram of the structure of a sheath locking knob in an implementation method disclosed in Example 2 of the present invention;

[0066] Fig.18 This is a schematic diagram of the structure of a knob body in an implementation manner disclosed in Example 2 of the present invention;

[0067] Fig.19 A schematic diagram of the structure of a clamping member in an implementation manner disclosed in Example 2 of the present invention;

[0068] Fig. 20 This is a schematic diagram of the operation of a 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 part 10, guide part 11, main body part 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, clamp arm 15, first boss 151, barb structure 152, catheter part 20, middle sheath tube 21, inner sheath tube 22, first cavity 221, second cavity 222, proximal operating part 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] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually 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 clearly 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" and the like are only used to distinguish the description and cannot be understood as indicating or implying relative importance. The "proximal end" mentioned in the text refers to the end close to the operator along the length direction of the leaflet cutting device, and the "distal end" refers to the end away from the operator along the length direction of the leaflet cutting device.

[0073] It is known to those skilled in the art that in order to achieve their respective functions and meet the requirements of surgical operations, the specific shapes / sizes / angles of the structures can be adaptively adjusted. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0074] Example 1

[0075] The present 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 — Fig.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 tube 21 and an inner sheath tube 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 double-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 a guide wire 50, and the blade guide groove 121 is open on the side to accommodate the axial movement of the blade 14, and 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 arranged in the middle of the blade guide groove 121, and is a side open area of ​​the blade guide groove 121, and when the blade 14 moves therein, the cutting operation of the leaflet can be realized; further, 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 distal blade hidden cavity 1211, when the blade 14 moves to the proximal end of the blade guide groove 121, the blade is located in the proximal blade hidden cavity 1211, by arranging 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 portion 10 can be effectively reduced.

[0080] In some embodiments, the guide portion 11 is roughly conical and fixedly connected to the distal opening of the hollow inner cavity, that is, the guide portion 11 is the farthest 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 a 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 stimulation 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 passing performance 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 head 14, and can protect the safety of the patient and the operator.

[0083] like Figure 6 In some embodiments, the cutter head 14 is disposed inside the main body and can move axially between the distal end and the proximal end of the cutter head guide groove 121. The structure of the cutter head 14 includes a cutter head body and a control rod 143. The control rod 143 is used to control the axial movement of the cutter head body. The cutter head body is provided with double-sided 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 side of the blade of the blade body is also made of a conductive material. The control rod 143 is connected and conductive to the proximal end of the blade body. When not powered on, only the axial movement of the blade body in the blade guide groove 121 can be controlled to achieve physical cutting of the leaflets. When powered on, the blades on one or both sides made of a conductive material can achieve electrical cutting of the leaflets, which is particularly suitable for calcified leaflets. Specifically, physical cutting or electrical cutting of the blade 14 can be selected as needed according to clinical use requirements.

[0085] In some embodiments, the outer surface of the control rod 143 is also provided with an insulating coating to prevent accidental electric shock when the blade body is performing electrical 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 electrosurgical unit or a high-frequency electrosurgical unit.

[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 is required 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 realize the hidden structure of the cutting head 14 and ensure the smooth movement of the cutting head 14, the height of the cutting head body is smaller than the radius of the main body; further, the double-sided blades are obliquely arranged on the cutting head body, the outer blades 141 of the double-sided blades are facing the distal end, and the inner blades 142 of the double-sided blades are facing the proximal end. When the starting position of the cutting head 14 is at the distal end of the cutting head guide groove 121, after capturing the leaflet, the cutting head 14 is pulled back toward the proximal end, and the inner blade 142 can realize cutting from the root of the leaflet; when the starting position of the cutting head 14 is at the proximal end of the cutting head guide groove 121, after capturing the leaflet, the cutting head 14 is pushed toward the distal end, and the outer blade 141 can start cutting from the apposing edge of the leaflet, thereby realizing 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 makes the cutting edge of the outer blade 141 tilt from the axis of the blade body to the outside; the inner blade 142 is set at a second inclination angle relative to the axis of the blade body, and the second inclination angle makes the cutting edge of the inner blade 142 tilt from the axis of the blade body to the outside; 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 the cutting more efficient; on the other hand, the pressure during cutting can be reduced, creating an effect similar to "sliding cutting", making the cutting smoother and reducing tissue tearing; by adjusting the first inclination angle and the second inclination 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 clamp 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 clamp arm 15. The movable member 13 can move axially relative to the main body to drive the clamp arm 15 to rotate around the main body to achieve the opening and closing of the clamp arm 15. When the clamp arm 15 is closed 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 slidably 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 technicians in this field 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 clamp arm 15; Figure 8 When the leaflet cutting device is opened, the first boss 151 of the clamp arm 15 is subjected to the horizontal pulling force FA of the moving part 13, and 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 force application to the rotation axis. According to the moment formula M=F*L, the force arm is long, the clamp arm 15 is subjected to less force, and it is easier to open and close; refer to Fig. 9When the leaflet cutting device is closed, the first boss 151 of the clamp arm 15 is subjected to the horizontal thrust FB of the moving part 13, and 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 rotation axis. According to the moment formula M=F*L, the force arm is short, and the clamp arm 15 exerts a greater force on the main part at this time, and the clamping force is better. In this embodiment, the specific position of the notch 131 is no longer limited, and those skilled in the art can adjust it according to the actual needs of different patients.

[0095] In some embodiments, a developing ring is provided on the outer side of the clamp arm 15 for observing the position of the leaflet cutting device under surgical angiography 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 to prevent the leaflet from sliding or shifting during the cutting process, so as to facilitate the subsequent cutting operation. Optionally, the barb structure 152 includes but is not limited to a tooth shape, a cone shape, and 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, so as to make the leaflet fit the clamp arm 15 and the main body more closely.

[0097] Specifically, barb structures 152 of different shapes / sizes can adapt to leaflet tissues of different thicknesses, hardnesses, and textures. For example, a toothed structure may be more suitable for thin leaflets, while a stronger conical or rake-shaped structure may be required for thicker or calcified leaflets. By distributing the barbs in different quantities, the pressure distribution can be optimized to avoid excessive local pressure causing tissue tearing and other damage. By selecting the appropriate barb shape, size, and quantity, it is possible to minimize damage to the leaflet tissue while providing sufficient fixing force, which is not specifically limited in this embodiment.

[0098] In some embodiments, the clamp arm 15 and the moving member 13 are both made of insulating materials to prevent accidental electric shock when the cutter 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, and the maximum diameter does not exceed 6 mm, so as 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, so as 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 leaflet cutting is performed, the inner sheath 22 is relatively fixed, and the middle sheath 21 can move axially to drive the movable part 13 to move, thereby finally realizing the opening and closing of the clamp arm 15.

[0101] like Fig.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 clamp arm opening and closing mechanism and a blade moving mechanism, wherein the clamp arm opening and closing mechanism is used to control the opening and closing of the clamp arm 15, and the blade moving mechanism is used to control the movement of the blade head 14.

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

[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 arranged 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 angle of the clamp arm 15 reaches the maximum and remains 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 angle of the clamp arm 15 to avoid damaging 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 in a tightly closed state, stably clamping the valve leaflet for subsequent cutting operations.

[0106] like Fig.12 — Fig.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 separately arranged 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 thereto.

[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 an external thread is provided on its surface; the threaded rotating part 34 is rotatably assembled on 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, thereby driving the control rod 143 to move, and finally realizing the movement of the cutter head 14 to cut the leaflet.

[0108] In some embodiments, the proximal end of the inner sheath fixing member 33 also extends into the interior of the threaded moving member 35 to limit the circumferential rotation of the threaded moving member 35 to 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 also connected to the control rod 143. When the operating handle is connected to an external power source, the blade head 14 can perform an electric cutting operation.

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

[0111] refer to Fig. 20 In this embodiment, when the distal cutting portion 10 of the leaflet cutting device reaches the aortic valve 70 along the aortic arch 60, the clamp arm 15 can be controlled to open and close by rotating the middle sheath rotating member 32 to clamp and fix the aortic valve 70, and then the threaded rotating member 34 can be rotated to control the cutter 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 supply, the electric cutting of the cutter head 14 can also be achieved. After the leaflet cutting is completed, the leaflet cutting device withdraws from the human body along the guide wire 50 to facilitate the subsequent surgical process.

[0112] Example 2

[0113] refer to Fig.16 — Fig. 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 Fig.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 the middle sheath 21, the proximal end of the outer sheath 42 is passed through the bending control handle 41, and 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 Fig.17 — Fig.19In some embodiments, the middle sheath locking knob 43 includes a knob body 431 and a clamping piece 432. The knob body 431 is threadedly matched with the clamping piece 432. The knob body 431 has an empty slot in the middle, 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 piece 432; the distal end of the clamping piece 432 is threadedly matched with the bending control handle 41, and the proximal structure of the clamping piece 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 a thread. 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 and preventing it from accidentally moving during transportation, thereby reducing surgical risks.

[0117] like Fig. 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 portion 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 modes, which are merely illustrative rather than 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 within the protection of the present invention.

Claims

1. A leaflet cutting device, characterized in that: The invention comprises a distal cutting portion, wherein the distal cutting portion comprises: -Main body; - a cutting head, arranged inside the main body, capable of axially moving between the distal end and the proximal end of the main body, the cutting head being provided with double-sided cutting edges for cutting the valve leaflets; - 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; - a moving member, which is slidably connected to the clamp arm, and can move axially relative to the main body, and is used to drive the clamp arm to rotate around the main body to achieve 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 comprises: - a main body part, provided with a hollow inner cavity and a blade guide groove; the hollow inner cavity is provided with a distal opening and a proximal opening for passing a guide wire; the blade guide groove and the hollow inner cavity are isolated from each other and are used to accommodate the axial movement of the blade; - a guide portion connected to the distal opening and communicating with the hollow inner cavity.

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

4. The leaflet cutting device according to claim 2, characterized in that: The cutter head comprises: - a cutter head body, wherein the height of the cutter head body is smaller 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; - a control rod connected to the proximal end of the cutter head body and used for controlling the axial movement of the cutter head body in the cutter head guide groove.

5. The leaflet cutting device according to claim 4, 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.

6. The leaflet cutting device according to claim 5, 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 arranged 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.

7. The leaflet cutting device according to claim 6, characterized in that: The clamp arm is connected to the main body by 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 movable member; the axial movement of the movable member drives the clamp arm to rotate around the hinge point to achieve opening and closing, and when the clamp arm is in a closed state, the outer surface of the clamp arm and the outer contour of the hidden cavity are located on the same cylindrical surface.

8. The leaflet cutting device according to claim 7, characterized in that: The inner side of the clamp arm is provided with a barb structure, and the barb structure is used to fix the valve leaflet; the outer side of the clamp arm is provided with a developing ring.

9. The leaflet cutting device according to claim 7, characterized in that: The movable member is sleeved on the proximal outer side of the main member in a cylindrical shape and can move axially along the main member; The outer peripheral surface of the moving part is provided with a notch, which matches the first boss so that the first boss can 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.

10. The leaflet cutting device according to any one of claims 1 to 9, characterized in that: It also includes a proximal operating part and a catheter part, wherein two ends of the catheter part are respectively connected to the distal cutting part and the proximal operating part; The catheter part comprises an inner sheath tube and a middle sheath tube, 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; The proximal operating part comprises an operating handle, in which a clamp arm opening and closing mechanism and a cutter head moving mechanism are arranged. 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.

11. The leaflet cutting device according to claim 10, characterized in that: A middle sheath fixing piece is provided at the distal end of the operating handle, the middle part of the middle sheath fixing piece is through-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 middle sheath tube to move axially, and finally drive the clamp arm to open and close through the axial movement of the moving member.

12. The leaflet cutting device according to claim 11, 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 slide groove is twistedly arranged on the inner side of the middle sheath rotating piece, and the second boss is arranged in the slide groove. The rotation of the middle sheath rotating piece can make the second boss move in the slide groove, thereby driving the axial movement of the middle sheath fixing piece.

13. The leaflet cutting device according to claim 12, characterized in that: Limiting grooves are respectively provided at both ends of the slide 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.

14. The leaflet cutting device according to claim 10, 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 separately arranged 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 knife head; An inner sheath fixing piece is fixedly connected inside the operating handle, and the separated first cavity and the second cavity are both passed through the inner sheath fixing piece and fixedly connected thereto.

15. The leaflet cutting device according to claim 14, characterized in that: The cutter head moving mechanism is arranged at the proximal end of the operating handle, and comprises a thread moving part and a thread 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.

16. The leaflet cutting device according to claim 15, characterized in that: The threaded moving part 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.

17. A leaflet cutting system, characterized in that: It comprises a leaflet cutting device as described in any one of claims 10 to 16, and also comprises a bending control delivery device.

18. The leaflet cutting system according to claim 17, characterized in that: 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.

19. The leaflet cutting system according to claim 18, characterized in that: The bending control conveying 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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