Valve leaflet cutting apparatus and system

Abstract

The present invention relates to a valve leaflet cutting apparatus and system. The valve leaflet cutting apparatus comprises at least a distal-end cutting portion. The distal-end cutting portion comprises a main body member, a cutter head, a clamping arm, and a moving member. The cutter head is arranged inside the main body member and is capable of axially moving between the distal end and the proximal end of the main body member, and the cutter head is provided with double-sided cutter edges for cutting a valve leaflet; the proximal end of the clamping arm is rotatably connected to the main body member, and the distal end is configured to clamp and fix the valve leaflet; the moving member is slidably connected to the clamping arm, and the moving member can move axially relative to the main body member, so as to drive the clamping arm to rotate around the main body member, thereby achieving the opening and closing of the clamping arm. When the clamping arm is closed and fixes the valve leaflet, the axial movement of the cutter head implements cutting of the fixed valve leaflet.

Description

A leaflet cutting device and system Technical Field

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

[0002] Aortic stenosis is a common and deadly cardiovascular disease. 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 remains a key challenge in procedures such as TAVR, ViV-TAVR (valve-in-valve TAVR), and Redo-TAVR (repeated TAVR), limiting the application of these techniques in more elderly patients with aortic valve disease.

[0003] The BASILICA technique was proposed to reduce the risk of coronary artery blockage. This technique involves using an electrical wire to cut and tear the degenerated and thickened autologous or decayed bioprosthetic leaflets to create a triangular window before implanting an interventional valve. This increases the flow of blood to the aortic sinus, thereby improving coronary 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 the potential of the BASILICA technique in preventing coronary artery obstruction, there are still some shortcomings, especially the lack of a device specifically designed for leaflet cutting in existing technologies, which limits the further development and application of related technologies. Summary of the Invention

[0005] This invention discloses a leaflet cutting device and system, which aims to solve the technical problems existing in the prior art.

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

[0007] On one hand, the present invention provides a leaflet cutting device, including a distal cutting section, the distal cutting section comprising:

[0008] -Main components;

[0009] - The cutter head is located inside the main body and can move axially between the distal and proximal ends of the main body. The cutter head is equipped with double-sided cutting edges for cutting the leaflets.

[0010] - A clamping arm, the proximal end of which is rotatably connected to the main body, and the distal end of which is used to clamp and fix the leaflets;

[0011] - The movable component is slidably connected to the clamping arm. The movable component can move axially relative to the main body to drive the clamping arm to rotate around the main body, thereby opening and closing the clamping arm.

[0012] When the clamping arm closes and fixes the leaflet, the axial movement of the cutter head achieves the cutting of the fixed leaflet.

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

[0014] - The main body has a hollow inner cavity and a cutter guide groove; the hollow inner cavity has a distal opening and a proximal opening for guiding the guide wire; the cutter guide groove is isolated from the hollow inner cavity to accommodate the axial movement of the cutter head;

[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 comprises a rigid material; the guide comprises a flexible material.

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

[0018] - The blade body has a height less than the radius of the main body. The double-sided blades are inclinedly disposed on the blade body, with the outer blades of the double-sided blades facing the far end and the inner blades of the double-sided blades facing the near end.

[0019] - A control lever, connected to the proximal end of the cutter head body, is used to control the axial movement of the cutter head body within 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 cutter head body includes a conductive material for electrically cutting the leaflet tissue when energized. Both the main body and the guide portion include electrically insulating materials.

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

[0022] - A hidden cavity for the cutter head is provided at both the proximal and distal ends of the cutter head guide groove. The length of the hidden cavity is not less than the length of the cutter head body, and the height of the hidden cavity is greater than the height of the cutter head body.

[0023] - The guide cavity is located in the middle of the cutter head guide groove. The side of the guide cavity is open. When the cutter head body moves in the guide cavity, the cutting operation of the leaf is realized.

[0024] As a preferred technical solution, the clamping arm and the main body are connected 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 is used to drive the clamping arm to rotate around the hinge point to realize opening and closing. When the clamping arm is in the 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, the inner side of the clamping arm is provided with a barbed structure for fixing the leaflets; the outer side of the clamping arm is provided with a developing ring.

[0026] As a preferred technical solution, the movable component is cylindrically sleeved on the outer side of the near end of the main component and can move along the axial direction of the main component;

[0027] The outer circumferential surface of the moving part is provided with a groove, which matches the first boss, allowing the first boss to slide smoothly within it; the groove is inclined, and the length of the groove matches the maximum opening and closing angle of the clamping arm.

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

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

[0030] The proximal operating unit includes an operating handle, which contains a clamping arm opening and closing mechanism and a cutting head moving mechanism. The clamping arm opening and closing mechanism is used to control the opening and closing of the clamping arm, and the cutting head moving mechanism is used to control the movement of the cutting head.

[0031] As a preferred technical solution, the distal end of the operating handle is provided with a middle sheath fixing member, the middle of the middle sheath fixing member is through, and the proximal end of the middle sheath tube is inserted into the middle sheath fixing member and fixedly connected thereto.

[0032] The clamping 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. Finally, the clamping arm is opened and closed by the axial movement of the moving part.

[0033] As a preferred technical solution, the outer side of the middle sheath fixing member is provided with a second protrusion, and the clamping arm opening and closing mechanism includes a middle sheath rotating member. The middle sheath rotating member is rotatably disposed on the outer side of the far end of the operating handle. The inner side of the middle sheath rotating member is provided with a sliding groove, and the second protrusion is disposed in the sliding groove. The rotation of the middle sheath rotating member can cause the second protrusion to move in the sliding groove, thereby driving the axial movement of the middle sheath fixing member.

[0034] As a preferred technical solution, limiting grooves are provided at both ends of the slide, and the limiting grooves are used to limit the opening and closing angle 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 at the proximal end. The first lumen is used to pass through the guide wire, and the second lumen is used to pass through the control rod of the cutter head.

[0036] An inner sheath fixing component is fixedly connected inside the operating handle. The separated first cavity and second cavity are both inserted into the inner sheath fixing component and fixedly connected to it.

[0037] As a preferred technical solution, the cutting head moving mechanism is located 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 inserted into the threaded rotating component.

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

[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 component is rotatably mounted on the proximal exterior of the operating handle. The threaded rotating component has an internal thread that matches the threaded moving component. The rotation of the threaded rotating component drives the axial movement of the threaded moving component, which in turn drives the movement of the control rod, ultimately achieving the axial movement of the cutter head.

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

[0043] As a preferred technical solution, the bending control conveying device includes an outer sheath and a bending control handle. The lumen of the outer sheath is used to insert the middle sheath, and the proximal end of the outer sheath is inserted into 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 conveying device also includes a middle sheath locking knob, which is located near the bending control handle and can be interference-fitted with the middle sheath tube to lock it.

[0045] The technical solution adopted in this invention can achieve the following beneficial effects:

[0046] This invention primarily provides a leaflet cutting device, which comprises a distal cutting section and a proximal operating section. The distal cutting section integrates clamping, cutting, and transport functions. Specifically, it includes a main body, a moving part, a blade, and a clamping arm. The blade has double-sided cutting edges to adapt to different cutting directions and possesses electrocutting capabilities. During transport, the blade is concealed, improving safety during intravascular delivery. The clamping arm is closed during transport, forming a roughly continuous cylindrical surface with the main body, reducing the risk of damage to the vessel wall. When opened, the clamping arm has barbs on its inner side, improving the fixation effect on leaflets of different shapes. Furthermore, the proximal operating section includes a clamping arm opening and closing mechanism and a blade moving mechanism. The clamping arm opening and closing mechanism allows the operator to precisely control the opening angle and speed of the clamping arm, while the blade moving mechanism enables 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 delivery device. The bending control 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. Attached Figure Description

[0048] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0049] Figure 1 is a schematic diagram of the structure of the leaf cutting device in one embodiment of the present invention;

[0050] Figure 2 is a schematic diagram of the distal cutting part when the clamping arm is closed in one embodiment of the present invention.

[0051] Figure 3 is a schematic diagram of the distal cutting part when the clamping arm is opened in one embodiment of the present invention;

[0052] Figure 4 is a cross-sectional view of the cutter head body at the far end of the cutter head guide groove in one embodiment of the present invention;

[0053] Figure 5 is a cross-sectional view of the cutter head body when it is located near the cutter head guide groove in one embodiment of the present invention;

[0054] Figure 6 is a schematic diagram of the blade head structure in one embodiment of the present invention disclosed in Embodiment 1;

[0055] Figure 7 is a schematic diagram of the clamping arm in one embodiment of the present invention disclosed in Embodiment 1;

[0056] Figure 8 is a force diagram of the clamping arm and the moving part when the clamping arm is opened in one embodiment of the present invention;

[0057] Figure 9 is a force diagram of the clamping arm and the moving part when the clamping arm is closed in one embodiment of the present invention;

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

[0059] Figure 11 is a schematic diagram of the clamping arm opening and closing mechanism in one embodiment of Embodiment 1 of the present invention;

[0060] Figure 12 is a schematic diagram of a cutter head moving mechanism in one embodiment of Embodiment 1 of the present invention;

[0061] Figure 13 is a cross-sectional view of a threaded rotating component in one embodiment of the present invention disclosed in Embodiment 1;

[0062] Figure 14 is a schematic diagram of a threaded moving part in one embodiment of the present invention disclosed in Embodiment 1;

[0063] Figure 15 is a schematic diagram of the clamping arm opening and closing mechanism in one embodiment of the present invention disclosed in Embodiment 1;

[0064] Figure 16 is a schematic diagram of the structure of the leaflet cutting system in one embodiment of Embodiment 2 of the present invention;

[0065] Figure 17 is a schematic diagram of the structure of the sheath locking knob in one embodiment of Embodiment 2 of the present invention;

[0066] Figure 18 is a schematic diagram of the structure of the knob body in one embodiment of Embodiment 2 of the present invention;

[0067] Figure 19 is a schematic diagram of the structure of the clamping member in one embodiment of Embodiment 2 of the present invention;

[0068] Figure 20 is a schematic diagram of the operation of the leaflet cutting system in the heart in one embodiment of Embodiment 2 of the present invention.

[0069] Explanation of reference numerals in the attached drawings: Distal cutting section 10, guide section 11, main body section 12, blade guide groove 121, blade concealment cavity 1211, moving part 13, slot 131, blade 14, outer blade 141, inner blade 142, control lever 143, clamping arm 15, first boss 151, barb structure 152, guide section 20, middle sheath tube 21, inner sheath tube 22, first cavity 221, second cavity 222, proximal operating section 30, middle sheath fixation. Component 31, second boss 311, middle sheath rotating component 32, slide groove 321, inner sheath fixing component 33, threaded rotating component 34, threaded moving component 35, power interface 351, scale marking 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 component 432, clamping groove 4321, guide wire 50, aortic arch 60, aortic valve 70. Detailed Implementation

[0070] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0071] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance. The term "proximal end" refers to the end along the length direction of the leaflet cutting device that is closer to the operator, and the term "distal end" refers to the end along the length direction of the leaflet cutting device that is farther from the operator.

[0072] Those skilled in the art will understand that, in order to achieve their respective functions and meet the requirements of surgical procedures, the specific shape, size, angle, etc., of each structure can be adaptively adjusted. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of the present invention.

[0073] Example 1

[0074] This embodiment provides a leaflet cutting device, which is preferably suitable for transcatheter aortic valve resection, and is particularly suitable for treating aortic stenosis or calcification before implantation of an artificial valve, so as to improve coronary hemodynamics and reduce the risk of coronary artery obstruction.

[0075] Referring to Figures 1-15, the leaflet cutting device includes, from distal to proximal, a distal cutting section 10, a conduit section 20, and a proximal operating section 30. The distal cutting section 10 includes a main body, a moving part 13, a blade 14, and a clamping arm 15. The conduit section 20 includes a middle sheath 21 and an inner sheath 22. The proximal operating section 30 includes an operating handle, a clamping arm opening and closing mechanism, and a blade moving mechanism.

[0076] As shown in Figures 2 and 3, in some embodiments, the main body includes a main body portion 12 and a guide portion 11 connected thereto.

[0077] In some embodiments, the main body portion 12 is configured as a dual-cavity structure, including a hollow inner cavity and a cutter guide groove 121 that are isolated from each other, both extending along the axial direction of the main body portion 12. The hollow inner cavity has a distal opening and a proximal opening for guiding the guide wire 50. The cutter guide groove 121 is open on the side to accommodate the axial movement of the cutter head 14. During the movement, the cutter head 14 is exposed in the open area of ​​the cutter guide groove 121 to achieve the cutting of the leaflets.

[0078] As shown in Figures 4 and 5, in some embodiments, the cutter guide groove 121 further includes a guide cavity and a cutter head hiding cavity 1211. The guide cavity is located in the middle of the cutter guide groove 121 and is an open area on the side of the cutter guide groove 121. When the cutter head 14 moves therein, it can perform a cutting operation on the leaflets. Furthermore, a cutter head hiding cavity 1211 is provided at both the proximal and distal ends of the cutter guide groove 121, and the length of at least the cutter head hiding cavity 1211 located at the distal end is not less than [a certain value]. The length of the blade of the cutter head 14 and the height of the blade head concealment cavity 1211 are greater than the height of the blade of the cutter head 14. During the delivery of the cutter head 14, the blade is located in the distal blade head concealment cavity 1211. When the cutter head 14 moves to the proximal end of the cutter head guide groove 121, the blade is located in the proximal blade head concealment cavity 1211. By setting the cutter head 14 as a concealed structure, the risk of tissue damage caused by the exposure of the cutter head 14 during the delivery of the distal cutting part 10 can be effectively reduced.

[0079] In some embodiments, the guide portion 11 is generally conical and is 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. The guide portion 11 has an axially penetrating cavity that communicates with the hollow inner cavity of the main body portion 12 for inserting the guide wire 50. Specifically, the guide wire 50 can play a positioning role during the operation. After 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.

[0080] 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 reduce the stimulation and potential damage risk to the blood vessel wall on the one hand, and better adapt to the bending and changes of the blood vessel on the other hand, thereby improving the passability of the device. 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 valve leaflets.

[0081] 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, thus protecting the safety of the patient and operator.

[0082] As shown in Figure 6, in some embodiments, the cutter head 14 is disposed inside the main body and can move axially between the distal and proximal ends 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 cutting edges for cutting the petals, so as to achieve cutting of the petals in different ways during the movement.

[0083] In some embodiments, the control lever 143 is made of a conductive material, and at least one edge of the blade body is also made of a conductive material. The control lever 143 is connected and conductive to the proximal end of the blade body. When no power is applied, only the axial movement of the blade body within the blade guide groove 121 can be controlled to achieve physical cutting of the leaflets. When power is applied, one or both edges made of conductive material can achieve electrical cutting of the leaflets, which is particularly suitable for calcified leaflets. Specifically, the physical cutting or electrical cutting of the blade 14 can be selected as needed according to clinical requirements.

[0084] In some embodiments, the outer surface of the control lever 143 is also provided with an insulating coating to prevent accidental electric shock when the cutter body is performing electric cutting.

[0085] In some embodiments, when only one side of the cutting edge is made of a conductive material, the other side of the cutting edge may be made of a non-conductive material or coated with an insulating layer, in which case the cutting head body is configured as a monopolar electrosurgical unit or a high-frequency electrosurgical unit.

[0086] In some embodiments, when both the outer blade 141 and the inner blade 142 of the blade body are made of conductive material, the blade body is configured as a bipolar electrosurgical unit or a high-frequency electrosurgical unit. It should be noted that when the blade body is configured as a bipolar electrosurgical unit, a gap needs to be provided between the outer blade 141 and the inner blade 142, and the current generated between them is mainly used to coagulate fine tissues.

[0087] In some embodiments, in order to achieve a concealed structure for the cutter head 14 and ensure smooth movement of the cutter head 14, the height of the cutter head body is less than the radius of the main body. Further, the double-sided cutting edges are inclinedly disposed on the cutter head body, with the outer cutting edge 141 of the double-sided cutting edges facing the distal end and the inner cutting edge 142 of the double-sided cutting edges facing the proximal end. When the starting position of the cutter head 14 is at the distal end of the cutter head guide groove 121, after capturing the leaflet, the cutter head 14 is pulled back to the proximal end, and the inner cutting edge 142 can achieve cutting from the root of the leaflet. When the starting position of the cutter head 14 is at the proximal end of the cutter head guide groove 121, after capturing the leaflet, the cutter head 14 is pushed to the distal end, and the outer cutting edge 141 can start cutting from the mating edge of the leaflet, thereby achieving partial cutting of the leaflet.

[0088] In some embodiments, the outer blade 141 is set at a first tilt angle relative to the axis of the blade body, the first tilt angle causing 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 tilt angle relative to the axis of the blade body, the second tilt angle causing the cutting edge of the inner blade 142 to tilt outward from the axis of the blade body; the first tilt angle and the second tilt angle may be the same or different, and can be adjusted and selected according to the valve lesion, and are not specifically limited in this embodiment.

[0089] Specifically, by tilting the double-sided blades, 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 a "sliding cut" effect, making the cutting smoother and reducing tissue tearing. By adjusting the first and second tilt angles, the double-sided blades can be adapted to the cutting needs of different directions and positions, and can also adapt to leaflet tissues of different thicknesses and hardnesses.

[0090] Referring to Figures 2, 3, and 7, in some embodiments, the proximal end of the clamping arm 15 is rotatably connected to the main body, and its distal end is used to clamp and fix the petal. The movable member 13 is cylindrically sleeved on the proximal end of the main body and 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, thereby opening and closing the clamping arm 15. When the clamping arm 15 is closed and clamps and fixes the petal, the fixed petal is cut by the axial movement of the cutter head 14.

[0091] In some embodiments, the clamping arm 15 is connected to the main body via a pivotal connection structure such as rivets to form a rotatable hinge point. A first boss 151 is provided on the proximal side of the hinge point, and the first boss 151 is slidably connected to the moving member 13. The outer peripheral surface of the moving member 13 is provided with an inclined groove 131, which matches the first boss 151. The first boss 151 can slide smoothly along the groove 131. The axial movement of the moving member 13 can drive the clamping arm 15 to rotate around the hinge point to achieve opening and closing. When the clamping arm 15 is in the closed state, the outer surface of the clamping 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.

[0092] In some embodiments, the length of the slot 131 determines the maximum opening and closing angle of the clamping arm 15. By adjusting the length of the slot 131, specific opening and closing angles can be designed for different sizes of leaflets to improve adaptability. The tilt angle of the slot 131 is matched with the opening and closing speed of the clamping arm 15. A larger tilt 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 tilt angle of the slot 131, the opening and closing speed of the clamping arm 15 can be controlled to avoid sudden impact on fragile tissues. In this embodiment, the length or tilt angle of the slot 131 is no longer specifically limited. Those skilled in the art can adjust it according to the actual needs of different patients.

[0093] In some embodiments, the position of the slot 131 also determines the opening and closing force of the clamping arm 15. Referring to Figure 8, when the leaflet cutting device is open, the first protrusion 151 of the clamping arm 15 is subjected to a horizontal pulling force FA from the moving member 13. FA is decomposed into a force FA1 along the direction of the slot 131 and a force FA2 perpendicular to the direction of the slot 131. L1 is the distance from the point of application of the force to the rotation axis. According to the torque formula M = F * L, a longer lever arm results in a smaller force on the clamping arm 15, making it easier to open and close. Referring to Figure 9, when the leaflet cutting device is closed, the first protrusion 151 of the clamping arm 15 is subjected to a horizontal pushing force FB from the moving member 13. FB is decomposed into a force FB1 along the direction of the slot 131 and a force FB2 perpendicular to the direction of the slot 131. L2 is the distance from the point of application of the force to the rotation axis. According to the torque formula M = F * L, a shorter lever arm results in a larger force applied to the main body by the clamping arm 15, leading to better clamping force. In this embodiment, the specific position of the slot 131 is no longer limited, and those skilled in the art can adjust it according to the actual needs of different patients.

[0094] In some embodiments, the outer side of the clamp arm 15 is provided with a contrast ring for observing the position of the leaflet cutting device under surgical angiography, so that the surgeon can make corresponding adjustments.

[0095] As shown in Figure 7, in some embodiments, the inner side of the clamping arm 15 is provided with a barb structure 152. When the clamping arm 15 is closed, the leaflet is located between the clamping arm 15 and the main body. The barb structure 152 can fix the position of the leaflet and prevent the leaflet from sliding or shifting during the cutting process, so as to facilitate subsequent cutting operations. Optionally, the barb structure 152 includes, but is not limited to, toothed, conical, and rake-shaped, and the barb structures 152 on both sides of the clamping arm 15 can be configured with different shapes and / or numbers to make the leaflet fit the clamping arm 15 and the main body more closely.

[0096] Specifically, barb structures 152 of different shapes and sizes can adapt to leaflet tissues of different thicknesses, hardness, and textures. For example, serrated structures may be more suitable for thinner leaflets, while stronger conical or rake-like structures may be needed for thicker or calcified leaflets. By varying the number of barbs, pressure distribution can be optimized, avoiding excessive local pressure that could lead to tissue tearing or other damage. By selecting appropriate barb shapes, sizes, and numbers, sufficient fixing force can be provided while minimizing damage to the leaflet tissue. This embodiment does not impose specific limitations on this aspect.

[0097] In some embodiments, both the clamping arm 15 and the moving part 13 are made of insulating material to prevent accidental electric shock during the electric cutting process of the cutter head 14, while reducing the heat generated during the electric cutting process from causing thermal damage to the surrounding area.

[0098] In some embodiments, when the clamping arm 15 is closed, the entire distal cutting portion 10 has a circular front view with a maximum diameter of no more than 6 mm to facilitate delivery in an artery; furthermore, the outer surface of the entire distal cutting portion 10 is a generally continuous cylindrical surface without other protruding structures to avoid damage to blood vessels or other tissues during delivery.

[0099] In some embodiments, the distal end of the middle sheath 21 is connected to the moving member 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 moving member 13 to move, and finally realize the opening and closing of the clamping arm 15.

[0100] As shown in Figure 10, in some embodiments, the proximal operating part 30 includes an operating handle, and the proximal ends of the middle sheath 21 and the inner sheath 22 are both inserted into the operating handle. The operating handle is also provided with a clamping arm opening and closing mechanism and a blade moving mechanism. 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 14.

[0101] As shown in Figure 11, in some embodiments, a middle sheath fixing member 31 is provided at the distal end of the operating handle. The middle sheath fixing member 31 is through the middle, and the proximal end of the middle sheath tube 21 passes through the middle sheath fixing member 31 and is fixedly connected to it. A second protrusion 311 is provided on the outer side of the middle sheath fixing member 31. The clamping arm opening and closing mechanism includes a middle sheath rotating member 32, which is rotatably disposed on the outer side of the distal end of the operating handle. The second protrusion 311 is slidably engaged with the middle sheath rotating member 32. When the middle sheath rotating member 32 is rotated, the middle sheath fixing member 31 can be controlled to move axially relative to the operating handle, and the middle sheath tube 21 can be moved axially. Finally, the clamping arm 15 is opened and closed by the axial movement of the moving member 13 relative to the main body.

[0102] In some embodiments, the middle sheath rotating member 32 includes a rotating outer shell and a sliding block fixed inside the rotating outer shell. The sliding block is provided with a torsional groove 321. The second protrusion 311 is slidably disposed in the groove 321 and can move smoothly therein. When the rotating outer shell is rotated, the second protrusion 311 can move in the groove 321. The rotational motion is converted into axial motion, which can drive the axial movement of the middle sheath fixing member 31, thereby controlling the opening and closing degree of the clamping arm 15.

[0103] Specifically, by adjusting the pitch and length of the slide groove 321, the opening angle and opening rate of the clamping arm 15 can be controlled, in order to find the best balance between precise control and rapid operation, reduce the possibility of sudden opening and closing of the clamping arm 15, and avoid accidental damage to the blood vessel wall, valve leaflet or other tissues.

[0104] In some embodiments, the two ends of the slide 321 are respectively provided with limiting grooves, which are used to limit the opening and closing angle of the clamping arm 15 or maintain the closed state of the clamping arm 15. Specifically, when the clamping arm 15 is opened and closed, the second protrusion 311 reaches the limiting groove, the opening and closing angle of the clamping arm 15 reaches the maximum and remains fixed, reducing the risk of instrument damage caused by excessive rotation by the operator. At the same time, the limiting groove can also limit the opening and closing angle of the clamping arm 15, avoiding damage to the blood vessel wall or other biological tissues due to excessive opening and closing angle during the opening and closing process of the clamping arm 15. When the clamping arm 15 is closed, the second protrusion 311 reaches the limiting groove on the other side, the clamping arm 15 remains in a tightly closed state, stably clamping the leaflet, so as to facilitate subsequent cutting operations.

[0105] As shown in Figures 12-15, in some embodiments, an inner sheath fixing member 33 is provided at the proximal end of the operating handle. The inner sheath fixing member 33 is stationary relative to the operating handle, and the proximal end of the inner sheath tube 22 is fixedly connected to the inner sheath fixing member 33. Specifically, the inner sheath tube 22 is configured as a double-lumen tube, including a first cavity 221 and a second cavity 222. The first cavity 221 is used to pass through the guide wire 50, and the second cavity 222 is used to pass through the control rod 143 of the cutter head 14. The first cavity 221 and the second cavity 222 are separated at the proximal end. After separation, the first cavity 221 and the second cavity 222 are both passed through the inner sheath fixing member 33 and fixedly connected to it.

[0106] In some embodiments, the cutter head moving mechanism includes a threaded moving member 35 and a threaded rotating member 34. The threaded moving member 35 is fitted inside the proximal end of the operating handle and has an external thread on its surface. The threaded rotating member 34 is rotatably fitted outside the proximal end of the operating handle and has an internal thread that matches the threaded moving member 35. The proximal end of the first cavity 221 of the inner sheath tube 22 passes through the threaded rotating member 34, and the proximal end of the second cavity 222 is connected to the threaded moving member 35. The control rod 143 passes through the second cavity 222 and is fixedly connected to the threaded moving member 35. When the threaded rotating member 34 is rotated, the threaded moving member 35 is moved axially, which in turn moves the control rod 143, ultimately realizing the movement of the cutter head 14 to cut the leaf blade.

[0107] In some embodiments, the proximal end of the inner sheath retainer 33 also extends into the interior of the threaded moving member 35 to restrict the circumferential rotation of the threaded moving member 35, ensuring that it can only move axially.

[0108] In some embodiments, the operating handle is also provided with a power interface 351, which is connected to the second cavity 222 and is connected to the control rod 143. When the operating handle is connected to an external power source, the cutter head 14 can perform electric cutting operation.

[0109] Referring to Figures 14 and 15, in some embodiments, the near end of the threaded moving part 35 is also provided with a scale mark 352, which can be used to determine the displacement of the cutter head 14 by the scale indicated by the threaded moving part 35.

[0110] Referring to Figure 20, in this embodiment, after the distal cutting part 10 of the leaflet cutting device reaches the aortic valve 70 along the aortic arch 60, the clamping arm 15 can be opened and closed by rotating the middle sheath rotating member 32 to clamp and fix the aortic valve 70. Subsequently, rotating the threaded rotating member 34 can control the blade 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, electrical cutting of the blade 14 can also be achieved. 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.

[0111] Example 2

[0112] Referring to Figures 16-20, this embodiment provides a leaflet cutting system, including the leaflet cutting device as described in Embodiment 1, and also including a bending control conveying device 40; the various technical features already included in Embodiment 1 are naturally inherited in this embodiment and will not be described again.

[0113] As shown in 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. The lumen of the outer sheath 42 is used to pass through the middle sheath 21. The proximal end of the outer sheath 42 passes through the bending control handle 41, which is used to adjust the bending angle of the outer sheath 42 to improve the system's navigation capability in complex vascular pathways. The middle sheath locking knob 43 is located at the proximal end of the bending control handle 41 and can be press-fitted with the middle sheath 21 to lock it.

[0114] Specifically, the structure of the bending handle 41 and the outer sheath tube 42 can be selected from the structure disclosed in any embodiment of the prior art, and no specific limitation is made here.

[0115] As shown in Figures 17-19, in some embodiments, the middle sheath locking knob 43 includes a knob body 431 and a clamping member 432. The knob body 431 and the clamping member 432 are threaded together. The knob body 431 has a slot in the middle, which is defined as the knob slot 4311. The knob slot 4311 is configured to be wider at the top and narrower at the bottom, which matches the proximal structure of the clamping member 432. The distal end of the clamping member 432 is threaded together with the bending control handle 41. The proximal structure of the clamping member 432 is configured as an open structure with a slot, which is defined as the clamping slot 4321, which can deform. During use, the clamping groove 4321 inside the clamping member 432 can pass through the middle sheath tube 21, and the knob body 431 is engaged with the clamping member 432 through threads. At this time, the knob groove 4311 presses against the clamping groove 4321, and the clamping groove 4321 deforms to clamp the middle sheath tube 21 inward, thereby locking the position of the middle sheath tube 21 and preventing it from moving accidentally during delivery, thus reducing surgical risks.

[0116] As shown in Figure 20, in this embodiment, when the leaflet cutting system is in use, the bending control delivery device 40 and the leaflet cutting device are together with the guide wire 50 to reach the target position in the patient's heart. The bending control delivery device 40 enables the leaflet cutting device to pass through large curved blood vessels such as the aortic arch 60 more easily. When the distal cutting part 10 of the leaflet cutting device reaches the aortic valve 70, the middle sheath locking knob 43 is rotated to de-lock the middle sheath tube 21, so as to continue the subsequent leaflet clamping and cutting operation. The specific method is the same as in the above embodiment 1, and will not be described again here.

[0117] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other modifications under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these modifications are within the protection scope of the present invention.

Claims

1. A leaflet cutting device, characterized in that, Includes a distal cutting portion, the distal cutting portion comprising: -Main components; - A cutting head, disposed inside the main body, is axially movable between the distal and proximal ends of the main body, and the cutting head is provided with double-sided cutting edges for cutting the leaflets; - A clamping arm, the proximal end of which is rotatably connected to the main body, and the distal end of which is used to clamp and fix the leaflets; - A movable component, slidably connected to the clamping arm, the movable component being axially movable relative to the main body, used to drive the clamping arm to rotate around the main body, thereby realizing the opening and closing of the clamping arm; When the clamping arm closes and fixes the leaflet, the axial movement of the cutter head achieves the cutting of the fixed leaflet.

2. The leaflet cutting device of claim 1, wherein, The main component includes: - The main body has a hollow inner cavity and a cutter guide groove; the hollow inner cavity has a distal opening and a proximal opening for guiding the guide wire; the cutter guide groove is isolated from the hollow inner cavity to accommodate the axial movement of the cutter head; - A guide portion, connected to the distal opening and communicating with the hollow inner cavity.

3. The leaflet cutting device of claim 2, wherein, The main body portion comprises a rigid material; the guide portion comprises a flexible material.

4. The leaflet cutting device of claim 2, wherein, The cutting head includes: - The blade body has a height less than the radius of the main body. The double-sided blades are inclinedly disposed on the blade body, with the outer blades of the double-sided blades facing the far end and the inner blades of the double-sided blades facing the near end. - A control lever, connected to the proximal end of the cutter head body, is used to control the axial movement of the cutter head body within the cutter head guide groove.

5. The leaflet cutting device of claim 4, wherein, The control rod includes a conductive material and is electrically connected to the cutter head body. At least one side of the cutter head body includes a conductive material for electrocutting the leaflet tissue when energized. Both the main body and the guide portion are made of electrically insulating material.

6. The leaflet cutting device of claim 5, wherein, The cutter head guide groove includes: - A blade tip concealment cavity is provided at both the proximal and distal ends of the blade tip guide groove. The length of the blade tip concealment cavity is not less than the length of the blade tip body, and the height of the blade tip concealment cavity is greater than the height of the blade tip body. - A guide cavity is provided in the middle of the cutter head guide groove. The side of the guide cavity is open. When the cutter head body moves in the guide cavity, it realizes the cutting operation of the leaf.

7. The leaflet cutting device of claim 6, wherein, 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 slidably connected to the moving member; the axial movement of the moving member is used to drive the clamping arm to rotate around the hinge point to realize opening and closing. When the clamping arm is in the closed state, the outer surface of the clamping arm and the outer contour of the hidden cavity are located on the same cylindrical surface.

8. The leaflet cutting device of claim 7, wherein, The inner side of the clamping arm is provided with a barbed structure for fixing the leaflets; the outer side of the clamping arm is provided with a developing ring.

9. The leaflet cutting device of claim 7, wherein, The movable component is cylindrically sleeved on the outer side of the proximal end of the main body component and is capable of moving along the axial direction of the main body component; The outer peripheral surface of the movable component is provided with a groove, which matches the first boss, allowing the first boss to slide smoothly within it; the groove is inclined, and the length of the groove matches the maximum opening and closing angle of the clamping arm.

10. The leaflet cutting device of any of claims 1-9, wherein, It also includes a proximal operating section and a catheter section, the two ends of which are respectively connected to the distal cutting section and the proximal operating section; The catheter portion includes an inner sheath and a middle sheath, the distal end of the middle sheath is connected to the movable component, and the distal end of the inner sheath is connected to the main body component. The proximal operating unit includes an operating handle, which contains a clamping arm opening and closing mechanism and a cutting head moving mechanism. The clamping arm opening and closing mechanism is used to control the opening and closing of the clamping arm, and the cutting head moving mechanism is used to control the movement of the cutting head.

11. The leaflet cutting device of claim 10, wherein, The distal end of the operating handle is provided with a middle sheath fixing member, the middle of the middle sheath fixing member is through, and the proximal end of the middle sheath tube is inserted into the middle sheath fixing member and fixedly connected thereto. The clamping 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 clamping arm to open and close through the axial movement of the moving member.

12. The leaflet cutting device of claim 11, wherein, The outer side of the middle sheath fixing member is provided with a second protrusion. The clamping arm opening and closing mechanism includes a middle sheath rotating member. The middle sheath rotating member is rotatably disposed on the outer side of the distal end of the operating handle. The inner side of the middle sheath rotating member is provided with a sliding groove. The second protrusion is disposed in the sliding groove. The rotation of the middle sheath rotating member can cause the second protrusion to move in the sliding groove, thereby driving the axial movement of the middle sheath fixing member.

13. The leaflet cutting device of claim 12, wherein, The two ends of the slide are respectively provided with limiting grooves, which are used to limit the opening and closing angle of the clamping arm or maintain the closed state of the clamping arm.

14. The leaflet cutting device of claim 10, wherein, The inner sheath is configured as a dual-lumen tube, including a first cavity and a second cavity, the first cavity and the second cavity being separated at the proximal end, the first cavity being used to pass through a guide wire, and the second cavity being used to pass through a control rod of the cutter head; An inner sheath fixing member is fixedly connected inside the operating handle. The separated first cavity and second cavity are both inserted into the inner sheath fixing member and fixedly connected thereto.

15. The leaflet cutting device of claim 14, wherein, The cutting head moving mechanism is located 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 component. The proximal end of the second cavity is connected to the threaded moving part, and the control rod passes through the second cavity and is fixedly connected to the threaded moving part.

16. The leaflet cutting device of claim 15, wherein, The threaded moving part is assembled inside the proximal end of the operating handle, and its surface is provided with external threads; The threaded rotating component is rotatably mounted on the proximal exterior of the operating handle. The threaded rotating component has an internal thread that matches the threaded moving component. The rotation of the threaded rotating component drives the axial movement of the threaded moving component, which in turn drives the movement of the control rod, ultimately achieving the axial movement of the cutter head.

17. A leaflet cutting system, comprising: The device includes the leaflet cutting device as described in any one of claims 10-16, and further includes a bending control conveying device.

18. The leaflet cutting system of claim 17, 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 through the middle sheath, and the proximal end of the outer sheath passes 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 of claim 18, wherein, The bending control conveying device further comprises a middle sheath locking knob, which is arranged at the proximal end of the bending control handle and can be in interference fit with the middle sheath tube to lock the middle sheath tube.

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