Valvulotomes and valvulotome systems

Abstract

The present invention discloses a valvulotome and a valvulotome system. The valvulotome comprises: two scissor arms and a driving assembly connecting the two scissor arms. The two scissor arms are connected in a cross-rotating manner, and a blade is provided on the side of each scissor arm away from the other scissor arm. The driving assembly is used to drive the two scissor arms to open or close. When the two scissor arms are in an open state, the angle between the two scissor arms is less than 180°, and when the two scissor arms are in a closed state, the two scissor arms are basically overlapped. The valvulotome provided by the present invention, on the one hand, has a contact between the blade and the valve during the cutting process similar to a point contact, with a small contact area, so that the blade can cut the valve more easily and the required pulling force is small; on the other hand, the driving assembly can control the opening angle of the two scissor arms according to different degrees of valve adhesion to control the cutting range of the valve, so that the cutting is more precise and the problem of incomplete cutting or excessive cutting is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valvulotome and a valvulotome system. Background Art

[0002] Aortic stenosis is mainly caused by sequelae of rheumatic fever, congenital aortic valve structural abnormalities, or senile aortic valve degeneration or calcification. Figure 1a and Figure 1b , Figure 1a The middle is a normal aortic valve. Figure 1b The middle ones are valves with different degrees of stenosis. The area of ​​the valve opening 1 at the valve 2 of the normal adult aorta should be ≥3.0cm 2 When the aortic valve 3 is narrowed, the area of ​​the aortic valve opening 4 is reduced to 1 / 3 of the normal value or smaller, which will cause blood flow obstruction. When the area of ​​the valve opening 4 is ≤1.5cm 2 When the transvalvular pressure difference and blood flow velocity increase, on the one hand, it can cause insufficient blood supply to various organs in the body, and on the other hand, it can cause a relative decrease in coronary blood flow, resulting in insufficient oxygen supply to the heart, which may eventually lead to complications such as arrhythmia, pulmonary hypertension, coronary heart disease, and heart failure. Generally speaking, during the compensatory stage, patients may not have typical clinical symptoms; while during the decompensated stage, patients may experience various symptoms, such as fatigue, exertional dyspnea, angina pectoris, dizziness or syncope, and even have a 10% to 20% probability of sudden cardiac death.

[0003] According to the different lesion structures of aortic valve stenosis, there are bicuspid valve deformity, tricuspid valve deformity, etc., among which the bicuspid valve deformity is the most common. Figure 2 Bicuspid aortic valve (BAV) refers to a congenital aortic valve with only two leaflets 5. In addition, in the classification standard of aortic valve leaflets, the situation similar to bicuspid valve caused by calcification and fusion of tricuspid valve is also classified as BAV. BAV is the most common congenital aortic valve stenosis, with a prevalence of about 2% in the population. It has a special anatomical structure, asymmetric leaflets 5, large sinus ellipticity, obstructed blood flow at the valve orifice 6, increased flow velocity, and easy formation of vortex.

[0004] In the prior art, a bicuspid percutaneous aortic valvulotome can be used to cut the valvular adhesion site, thereby treating valvular stenosis. However, the aortic valvulotome has the following technical problems:

[0005] 1) When the scissor blade is opened, it is in a straight line and parallel to the valve. The contact area between the scissor blade and the valve is too large, and a large pulling force is required to cut the valve.

[0006] 2) The length of the scissor arms after opening is fixed and cannot change, so the length that the cutter can cut cannot change. Valves with different physiological and anatomical structures, different degrees of calcification, and different degrees of adhesion should each require a different cutting length. The structure of the cutter will not be able to effectively adjust and control the cutting length, which may lead to incomplete cutting or excessive cutting. Summary of the invention

[0007] In order to solve the above technical problems or at least partially solve the above technical problems, the present invention provides a valvulotome and a valvulotome system.

[0008] In a first aspect, the present invention provides a valve cutter, comprising: two scissor arms and a driving assembly connecting the two scissor arms, the two scissor arms being connected in a cross-rotating manner, each scissor arm being provided with a blade on a side facing away from the other scissor arm, the driving assembly being used to drive the two scissor arms to an open state or a closed state; when the two scissor arms are in an open state, an angle between the two scissor arms is less than 180°, and when the two scissor arms are in a closed state, the two scissor arms are basically overlapped.

[0009] In a second aspect, the present invention provides a valvulotomy system, comprising: a tube body assembly, a handle, and the above-mentioned valvulotomy device, wherein the proximal end of the tube body assembly is connected to the handle, the distal end of the tube body assembly is connected to the drive assembly, and the handle is used to control the opening or closing of the two scissor arms through the tube body assembly.

[0010] In a third aspect, the present invention provides a valvulotomy system, comprising: a tube body assembly and the above-mentioned valvulotomy device, the tube body assembly comprising an outer tube and an inner tube sleeved in the outer tube, the inner tube being movable relative to the outer tube, the distal end of the outer tube being fixedly connected to the proximal end of the support member, and the distal end of the inner tube being fixedly connected to the proximal end of the sliding member.

[0011] In a fourth aspect, the present invention provides a valvulotomy system, comprising: a tube body assembly and the above-mentioned valvulotomy device, the tube body assembly comprising an outer tube and an inner tube sleeved in the outer tube, the inner tube being movable relative to the outer tube, the distal end of the outer tube being fixedly connected to the proximal end of the support member, and the distal end of the inner tube being fixedly connected to the proximal end of the transmission member.

[0012] In a fifth aspect, the present invention provides a valvulotomy system, comprising: a handle and the above-mentioned valvulotomy device, wherein the handle comprises a control member, and the control member is used to control the driving member to drive the two scissor arms to rotate separately or simultaneously.

[0013] The above technical solution provided by the embodiment of the present invention has the following advantages compared with the prior art:

[0014] The valve cutter provided by the embodiment of the present invention can cut the valve with the blades of the two scissor arms facing each other when the two scissor arms are in an open state. On the one hand, since the angle between the two scissor arms when they are open is less than 180°, the blade is inclined relative to the valve, and the contact between the blade and the valve during the cutting process is similar to point contact, with a small contact area, so the blade can easily cut the valve, and the required pulling force is small; on the other hand, the driving component can control the opening angle of the two scissor arms according to the different degrees of valve adhesion to control the cutting range of the valve, so that the cutting is more precise and the problem of incomplete cutting or excessive cutting is avoided. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0016] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0017] In the attached figure:

[0018] Figure 1a The aortic valve in its normal open and closed states;

[0019] Figure 1b It is the aortic valve with varying degrees of stenosis;

[0020] Figure 2 It is a bicuspid aortic valve;

[0021] Figure 3 It is a front view of the valvulotome according to the first embodiment of the present invention in an open state;

[0022] Figure 4 A partial cross-sectional view of the valvulotome according to the first embodiment of the present invention in an open state;

[0023] Figure 5 This is a three-dimensional view of a support member in the valvulotome according to the first embodiment of the present invention;

[0024] Figure 6 It is a front view of the valvulotome according to the first embodiment of the present invention in a closed state;

[0025] Figure 7 This is a partial exploded view of the valvulotome according to the first embodiment of the present invention in a closed state;

[0026] Figure 8A three-dimensional view of a sliding member in a valvulotome according to a first embodiment of the present invention;

[0027] Fig. 9 A three-dimensional view of a scissor arm in a valvulotome according to a first embodiment of the present invention;

[0028] Fig.10 A three-dimensional view of a connecting rod in a valvulotome according to a first embodiment of the present invention;

[0029] Fig.11 A partial exploded view of the valvulotome according to the first embodiment of the present invention in an open state;

[0030] Fig.12 A three-dimensional view of a valvulotomy system according to a first embodiment of the present invention;

[0031] Fig.13 A side view of the valvulotome according to the first embodiment of the present invention when the scissor arms are closed and the valvulotome has just entered the valve;

[0032] Fig.14 for Fig.13 A partial enlarged view of the dotted circle portion;

[0033] Fig.15 A top view of the valvulotome according to the first embodiment of the present invention when the scissor arms are closed and the valvulotome has just entered the valve;

[0034] Fig.16 A side view of the valvulotome according to the first embodiment of the present invention when it is opened;

[0035] Fig.17 for Fig.16 A partial enlarged view of the dotted circle portion;

[0036] Fig.18 A top view of the valvulotome according to the first embodiment of the present invention when it is opened to the maximum state;

[0037] Fig.19 A partial exploded view of the valvulotome according to the second embodiment of the present invention in an open state;

[0038] Fig. 20 Another partial exploded view of the valvulotome according to the second embodiment of the present invention in an open state;

[0039] Fig.21 A three-dimensional view of the valvulotome according to the third embodiment of the present invention in an open state;

[0040] Fig. 22 It is a front view of the valvulotomy system in the open state according to the third embodiment of the present invention;

[0041] Fig.23This is a partial exploded view of the valvulotome according to the third embodiment of the present invention;

[0042] Fig.24 A partial cross-sectional view of the valvulotome according to the third embodiment of the present invention in an open state;

[0043] Fig.25 A three-dimensional view of a scissor arm in a valvulotome according to a third embodiment of the present invention;

[0044] Fig.26 This is a three-dimensional view of a connector in a valvulotome according to a third embodiment of the present invention;

[0045] Fig. 27 This is a schematic diagram of the structure of a control component in a valvulotomy system according to Embodiment 3 of the present invention;

[0046] Fig.28 It is a partial front view of the valvulotomy system of the fourth embodiment of the present invention in the open state. DETAILED DESCRIPTION

[0047] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, the specific embodiments of the present invention are now described in detail with reference to the accompanying drawings. In the following description, it should be understood that the directions or positional relationships indicated by "front", "back", "up", "down", "left", "right", "longitudinal", "horizontal", "vertical", "horizontal", "top", "bottom", "inside", "outside", "head", "tail", etc. are based on the directions or positional relationships shown in the accompanying drawings, are constructed and operated in a specific direction, and are only for the convenience of describing the present technical solution, rather than indicating that the device or element referred to must have a specific direction, and therefore cannot be understood as a limitation to the present invention.

[0048] It should also be noted that, unless otherwise clearly specified and limited, the terms such as "installed", "connected", "connected", "fixed", "set" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there may be one or more intermediate elements. The terms "first", "second", "third", etc. are only for the convenience of describing the present technical solution, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", "third", etc. may explicitly or implicitly include one or more features. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0049] In the following description, specific details such as specific system structures, technologies, etc. are provided for the purpose of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present invention. However, it should be clear to those skilled in the art that the present invention may be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to prevent unnecessary details from obstructing the description of the present invention.

[0050] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device. The above definitions are only for the convenience of expression and cannot be understood as limitations of the present invention.

[0051] Embodiment 1

[0052] See also Figure 3-Figure 18 The valvulotome 100 provided in the first embodiment of the present invention comprises two scissor arms 11 and a driving assembly 10 connecting the two scissor arms 11. The two scissor arms 11 are connected in a cross-rotating manner, and a blade 110 is provided on the side of each scissor arm 11 away from the other scissor arm 11. The driving assembly 10 is used to drive the two scissor arms 11 to open or close. When the two scissor arms 11 are in an open state, the angle between the two scissor arms 11 is less than 180°; when the two scissor arms 11 are in a closed state, the two scissor arms 11 are basically overlapped.

[0053] In the above-mentioned valve cutter 100, when the two scissor arms 11 are in an open state, the blades 110 of the two scissor arms 11 facing each other can cut the valve. On the one hand, since the angle between the two scissor arms 11 when opened is less than 180°, the blade 110 is inclined relative to the valve, and the contact between the blade 110 and the valve during the cutting process is similar to point contact, with a small contact area, and the blade 110 can easily cut the valve, and the required pulling force is small; on the other hand, the driving component 10 can control the opening angle of the two scissor arms 11 according to different degrees of valve adhesion to control the cutting range of the valve, so that the cutting is more precise and the problem of incomplete cutting or excessive cutting is avoided.

[0054] It can be understood that the valvulotome 100 is provided with two scissor arms 11, and each scissor arm 11 is provided with a blade 110 on the side facing away from the other scissor arm 11, so that the scissor arm 11 can extend into the valve tissue and cut the part of the valve adhesion. The valvulotome 100 is provided with a driving assembly 10 to drive the two scissor arms 11 to rotate crosswise, and the driving assembly 10 can control the opening angle of the two scissor arms 11. By adjusting the opening angle of the scissor arms 11, the cutting length of the two blades 110 at the valve adhesion can be controlled. When the driving assembly 10 drives the two scissor arms 11 to open, the angle between the two scissor arms 11 is less than 180°; when the driving assembly 10 drives the two scissor arms 11 to close, the two scissor arms 11 are basically overlapped. In this way, during the process of the valvulotome 100 extending into the valve tissue, the two scissor arms 11 can be kept in a closed state for easy transportation; when reaching the cutting position, the drive assembly 10 controls the opening angle of the two scissor arms 11 to control the cutting range of the valve, making the valve cutting more precise, avoiding incomplete cutting or excessive cutting, reducing unnecessary surgical trauma, and improving the success rate of the operation.

[0055] Specifically, one end of each scissor arm 11 is connected to the drive assembly 10, and the other end is suspended. The two scissor arms 11 can be rotatably connected at the cross connection by means of a pivot or the like. The drive assembly 10 drives one end of the two scissor arms 11 to move toward or away from each other at the same time to respectively close or open the two scissor arms 11. The opening angle of the two scissor arms 11 can be continuously adjusted, that is, it can be achieved by controlling the movement of one end of the two scissor arms 11 by the drive assembly 10. For example, if the opening angle between the two scissor arms 11 is to be increased, the ends of the two scissor arms 11 connected to the drive assembly 10 can be controlled to move away from each other, and vice versa. The two scissor arms 11 are respectively provided with blades 110 between the cross connection and the suspended end, and the cutting edges of the two blades 110 are arranged away from each other, so as to achieve the cutting of the leaflet adhesion during the opening and closing process of the two scissor arms 11.

[0056] exist Figure 3 and Figure 6 In the embodiment, the angle a between the two scissor arms 11 ranges from -4° to 130°. When the two scissor arms 11 are in an open state, the distal ends of the two scissor arms 11 and the cross-connection of the two scissor arms 11 are in a V-shape. When the angle at which the two scissor arms 11 are opened reaches a maximum angle of 130°, the maximum cutting length b of the two scissor arms 11 ranges from 28 cm to 30 cm. When the two scissor arms 11 are in a closed state, the angle a between the two scissor arms 11 ranges from -4° to 0°, at which time the two scissor arms 11 are basically overlapped and present a straight-line structure.

[0057] See 3 and Figure 4The driving assembly 10 includes a sliding member 12, a support member 13 having a hollow inner cavity, and two connecting rods 14. The two scissor arms 11 are rotatably connected to the distal ends of the support member 13, the distal ends of the two connecting rods 14 are rotatably connected to the proximal ends of the two scissor arms 11, respectively, the proximal ends of the two connecting rods 14 are rotatably connected to the distal end of the sliding member 12, and the sliding member 12 is slidably arranged in the hollow inner cavity of the support member 13. In this way, since the two scissor arms 11 are rotatably connected to the distal ends of the support member 13, the sliding member 12 performs axial movement in the hollow inner cavity of the support member 13, and the two scissor arms 11 are driven to rotate at the same time through the two connecting rods 14, so that the two scissor arms 11 are in an open state or a closed state. When the slide 13 slides toward the distal end C, the connecting rod 14 is driven to move radially outward toward the support 13, so that the two scissor arms 11 move away from each other, that is, the two scissor arms 11 are driven to open; when the slide 12 slides toward the proximal end D, the connecting rod 14 is driven to move radially inward toward the support 13, so that the two scissor arms 11 rotate toward each other, that is, the two scissor arms 11 are driven to close. The angle between the two scissor arms 11 can be achieved by controlling the sliding process of the slide 12.

[0058] Specifically, see Figure 4 , Figure 5 and Fig. 9 The two scissor arms 11 are rotatably connected to the distal end of the support member 13 through the first connecting member 131. The first connecting member 131 passes through the two scissor arms 11 and is fixed to the distal end of the support member 131. The two scissor arms 11 can rotate around the first connecting member 131 relative to the distal end of the support member 13. A first connecting hole 111 is provided on each scissor arm 11, and two opposite second connecting holes 132 are also provided on the side wall of the support member 131. The first connecting member 131 passes through the first connecting hole 111 and the second connecting hole 132. The first connecting member 131 is preferably a pin or a rivet, which can ensure that the two scissor arms 11 rotate around the first connecting member 131 respectively driven by the two connecting rods 14.

[0059] See also Figure 3 , Figure 6 and Figure 7 , the two scissor arms 11 are in a crossed state around the first connecting member 131. When the two scissor arms 11 are in an open state, the distal end of one scissor arm 11 is located in the A direction of the center line of the valvulotome 100, and the proximal end of the scissor arm 11 is located in the B direction of the center line of the valvulotome 100, and the A direction and the B direction are symmetrical along the center line of the valvulotome 100. The distal end of the corresponding other scissor arm 11 is located in the B direction, and the proximal end of the scissor arm 11 is located in the A direction.

[0060] The support member 13 has a hollow inner cavity, and the sliding member 12 moves axially in the hollow inner cavity of the support member 13, thereby driving the scissor arm 11 to move through the connecting rod 14. In this way, when the sliding member 12 drives the connecting rod 14 to move, the connecting rod 14 drives the scissor arm 11 to be in an open state or a closed state. When the two scissor arms 11 are in an open state, the angle between the two scissor arms 11 is less than 180°, and the parts of the two scissor arms 11 located on the far side of the first connecting member 131 are basically V-shaped. When the two scissor arms 11 are in a closed state, the two scissor arms 11 are basically overlapped, and the whole is in a straight line, and the overall width dimension c of the two scissor arms 11 after overlapping is smaller than the outer diameter dimension of the support member 13, so that it can ensure that the valvulotome 100 can smoothly pass through the adjustable curved sheath used as a channel.

[0061] The side wall of the support member 13 is provided with two opposite movable grooves 133, the two connecting rods 13 are respectively arranged in the movable grooves 133, and the two scissor arms 11 are partially arranged in the movable grooves 133. It can be understood that in the closed state, the proximal end of the scissor arm 11 is located in the movable groove 133. In this way, through the provision of the movable groove 133, the movable space of the connecting rod 14 and the scissor arm 11 is increased, which facilitates the connection rod 14 to drive the scissor arm 11 to move, and the provision of the movable groove 133 can also make the two scissor arms 11 partially accommodated in the hollow inner cavity of the support member 13 when closed, which facilitates the scissor arms 11 to pass through the adjustable bending sheath.

[0062] See also Figure 4 and Figure 8 The sliding member 12 includes a platform 121 and a first connecting portion 122 disposed at the distal end of the platform 121. The platform 121 cooperates with the side wall of the support member 13, and the proximal ends of the two connecting rods 14 are rotatably connected to the first connecting portion 122. In this way, the sliding member 12 slides in the hollow inner cavity surrounded by the side wall of the support member 13, the platform 121 is fixedly connected to the first connecting portion 122, the platform 121 drives the first connecting portion 122 to slide in the hollow inner cavity, the first connecting portion 122 is connected to the two connecting rods 14, and the first connecting portion 122 drives the two connecting rods 14 to rotate. Driven by the sliding member 12, the two connecting rods 14 rotate relative to the sliding member 12, and the two connecting rods 14 respectively control the rotation of the two scissor arms 11. Therefore, by controlling the sliding of the sliding member 12, the opening angle of the two scissor arms 11 can be controlled, and the angle between the two scissor arms 11 can be controlled according to the stenosis degree of different valves, thereby controlling the cutting length of the two scissor arms 11.

[0063] Preferably, raised structures 123 are arranged at intervals on the circumferential side of the platform 121, which reduce the contact area with the side wall of the support member 13, making the sliding of the sliding member 12 smoother and reducing the shaking of the two scissor arms 11, making it easy to control the cutting depth and angle when cutting the valve.

[0064] The proximal ends of the two connecting rods 14 are rotatably connected to the first connecting portion 122 through the second connecting member 145. Specifically, a third connecting hole 142 is provided at the proximal end of the connecting rod 14, a fourth connecting hole 124 is provided on the first connecting portion 122, the third connecting hole 142 overlaps with the fourth connecting hole 124, and the second connecting member 145 penetrates the third connecting hole 142 and the fourth connecting hole 124, so that the connecting rod 14 can rotate around the second connecting member 142 relative to the first connecting portion 122. The second connecting member 145 is preferably a pin or a rivet, which can ensure that the two connecting rods 14 rotate around the second connecting member 145 under the sliding of the sliding member 12.

[0065] There is a good fit between the circumference of the platform 121 and the side wall of the support 13, and there is a certain gap between the circumference of the platform 121 and the side wall of the support 13, but the gap should not be too large. If the gap is too large, the sliding member 12 will have a large radial shake during the axial movement in the hollow inner cavity of the support 13, thereby causing the scissor arm 11 to shake, causing a series of adverse consequences. Preferably, the single-side gap between the circumference of the platform 121 and the side wall of the support 13 should be controlled within the range of 0.01-0.05mm.

[0066] In order to ensure the stability of the scissor arm 11 during the opening and closing process, and to prevent a large gap between the scissor arm 11 and the distal end of the support member 13, which may cause the scissor arm 11 to shake significantly during the opening and closing process, the scissor arm 11 and the support member 13 should be well matched, and the gap should be within a reasonable range. Preferably, the range of the single-sided gap between the distal end of the scissor arm 11 and the support member 13 should be controlled within 0.01mm-0.05mm. Figure 4 and Fig. 9 In order to prevent the two scissor arms 11 from shaking with each other or from deformation of the scissor arms 11 during use, which may cause the two scissor arms 11 to intersect or interfere with each other, thereby affecting the normal opening or closing of the scissor arms 11, the scissor arms 11 include a first boss 112, which is arranged at the connection between the scissor arms 11 and the support member 13. Specifically, the two scissor arms 11 are respectively provided with the first boss 112, and the two first bosses 112 are arranged opposite to each other. The two first bosses 112 allow the two scissor arms 11 to have a certain gap after being connected to the support member 13 through the first connecting member 131, thereby reducing the possibility of the scissor arms 11 intersecting or interfering with each other due to deformation or shaking of the scissor arms 11, and ensuring that the scissor arms 11 can be opened and closed normally.

[0067] See also Fig. 9, the distal end of the scissor arm 11 is an arc-shaped structure 113. Specifically, each scissor arm 11 is sharpened on one side away from the other scissor arm 11, and the distal end of the scissor arm 11 is a smooth arc-shaped structure 113, that is, the blade 110 does not completely penetrate the scissor arm 11, and is cut off near the distal end of the scissor arm 11, thereby forming an unsharpened blunt end at the distal end of the scissor arm 11. If the blade 110 completely penetrates the scissor arm 11 and forms a sharp blade 110 at the distal end, when the scissor arm 11 is opened to the maximum working angle, the distal end of the scissor arm 11 will have a certain possibility of contacting the inner wall of the blood vessel or tissue. At this time, the sharp blade 110 will scratch or cut the blood vessel or tissue when the valvulotome 100 is working, causing certain damage and risks to the human body. The distal end of the scissor arm 11 is configured as a smooth arc-shaped structure 113, and the blade 110 does not completely penetrate the scissor arm 11, leaving a blunt section of unsharpened edge near the distal end of the scissor arm 11 to avoid damage and risk to the human body.

[0068] See also Figure 4 and Fig.10 The connecting rod 14 includes a second boss 141, which is arranged at the connection between the connecting rod 14 and the proximal end of the scissor arm 11. In order to prevent the gap between the scissor arm 11 and the connecting rod 14 from causing the scissor arm 11 to swing during the opening or closing process, the second boss 141 is arranged on the connecting rod 14, so that the connecting rod 141 and the proximal end of the scissor arm 11 can fit together at the connection, eliminating the influence of the gap.

[0069] The proximal ends of the two scissor arms 11 are rotatably connected to the distal ends of the two connecting rods 14 through the third connecting member 147. Specifically, the proximal end of the scissor arm 11 is provided with a fifth connecting hole 114, the second boss 141 is provided with a sixth connecting hole 146 that penetrates the connecting rod 14, the sixth connecting hole 146 overlaps with the fifth connecting hole 114, and the third connecting member 147 penetrates the sixth connecting hole 146 and the fifth connecting hole 114, so that the scissor arm 11 and the connecting rod 14 can rotate relative to each other around the third connecting member 147. The third connecting member 147 is preferably a pin or a rivet.

[0070] It is worth mentioning that the valvulotome 100 should be guided to the treatment site by external images, such as computed tomography (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherence tomography (OCT), intracardiac echocardiography (ICE), etc. Therefore, a developing part should be provided on at least one scissor arm 11, and the developing part can be provided at the proximal end or the distal end of the scissor arm 11, and the developing material is preferably a metal material such as platinum, platinum, and tantalum.

[0071] See also Fig.11The first embodiment of the present invention further provides a valvulotomy system 200, comprising a tube assembly 20 and a valvulotomy device 100. The tube assembly 20 comprises an outer tube 21 and an inner tube 22 sleeved in the outer tube 21, and the inner tube 22 can move relative to the outer tube 21. The distal end of the outer tube 21 is fixedly connected to the proximal end of the support member 13, and the distal end of the inner tube 22 is fixedly connected to the proximal end of the sliding member 12.

[0072] Specifically, the outer tube 21 has a cavity and is a hollow tube. The outer tube 21 includes but is not limited to a braided mesh tube, a flexible steel tube, a coated spring tube, a spiral multi-strand twisted wire, etc. The outer tube 21 has good flexibility, a large tensile strength, and a small axial deformation when subjected to axial force. Preferably, the outer tube 21 is a composite tube or a spiral hollow tube. The distal end of the outer tube 21 and the proximal end of the support 13 are fixedly connected by welding, fusion, bonding, etc., and the firmness of the connection should be ensured so that it will not come off and break when subjected to working force. The connection method varies depending on the material of the outer tube 21 used. When a composite tube is selected as the outer tube 21, it is connected by fusion; when a spiral hollow tube is used, it is connected by welding.

[0073] The inner tube 22 can be a solid tube or a hollow tube. The inner tube 22 should have good flexibility, high tensile strength and good pushing performance. The inner tube 22 can be in various forms such as a flexible steel tube, a spring tube with a mandrel, a spiral hollow tube, a mechanical flexible shaft, a spiral multi-strand twisted wire, etc. The distal end of the inner tube 22 and the proximal end of the sliding member 12 are rigidly fixedly connected by welding, bonding, fusion, threaded connection, etc. In order to ensure the connection strength of the connection, welding is preferred in this embodiment.

[0074] See also Fig.12 The valvulotomy system 200 further includes a handle 23. The proximal end of the tube assembly 20 is connected to the handle 23, and the distal end of the tube assembly 20 is connected to the drive assembly 10. The handle 23 is used to control the opening or closing of the two scissor arms 11 through the tube assembly 20. Specifically, the distal end of the inner tube 22 is fixedly connected to the proximal end of the sliding member 12, and the proximal end of the inner tube 22 is connected to a control member (not shown) provided on the handle 23, such as a sliding structure. By operating the control member, the inner tube 22 is driven to move axially in the cavity of the outer tube 21, so as to control the sliding member 12 fixedly connected to the inner tube 22 to move in the hollow inner cavity of the support member 13, thereby driving the two scissor arms 11 to rotate through the connecting rod 14, thereby realizing the opening and closing of the two scissor arms 11.

[0075] See also Figure 13-Figure 18 The operation process of the valvulotomy system 200 of this embodiment is as follows:

[0076] Here we only take the dilatation of the aortic valve with bicuspid valve malformation as an example. Of course, the valvulotomy system is also applicable to the dilatation of the tricuspid valve malformation of the aortic valve or other valves, such as the mitral valve, tricuspid valve, pulmonary valve, etc.

[0077] S1. Puncture the femoral artery with a puncture device. After the puncture is completed, the valvulotome system 200 is delivered under the guidance of the adjustable curved sheath, so that the valvulotome 100 reaches the aortic valve through the femoral artery and the aortic arch.

[0078] S2. Under the guidance of the external developing device, the valvulotome 100 is passed through the narrow aortic valve, so that the two scissor arms 11 of the valvulotome 100 are completely located on the side of the aortic valve close to the left ventricle. At this time, the two scissor arms 11 of the valvulotome 100 are not opened, the junctions between the leaflets of the bicuspid aortic valve are adhered together, and the aortic valve is in a narrow state.

[0079] S3. The control member on the operating handle 23 controls the two scissor arms 11 to slowly open to a smaller and appropriate angle, and aligns the blade 110 with the valve adhesion site under the guidance of an external imaging device.

[0080] S4. Hold the handle 23 and use appropriate force to slowly pull the valve cutting system 200 from the left ventricle to the aorta, and use the blade 110 on the scissor arm 11 to cut the adhered aortic valve. During the pulling process, under the guidance of the external imaging device, the angle a of the two scissor arms 11 is slowly and gradually increased until the cutting effect reaches the ideal state. When the scissor arms 11 of the valvulotome 100 are pulled toward the proximal end, since the two scissor arms 11 are opened into a V shape, the blade 110 is always inclined relative to the valve. The contact between the blade 110 and the valve is similar to point contact, and the contact area is small. The blade 110 can concentrate on cutting a certain point on the valve adhesion site, and the valve can be cut more easily. The valve adhesion site is gradually cut and expanded from the proximal center to the proximal valve ring, and the required pulling force is greatly reduced compared with the line contact in the prior art.

[0081] S5. When the desired effect of aortic valve expansion is achieved, the control member on the operating handle 23 is operated to completely close the two scissor arms 11, and then the valvulotomy system 200 and the entire delivery device are withdrawn from the body.

[0082] Embodiment 2

[0083] See also Figure 19-20 Compared with the valvulotome 100 of the first embodiment, the valvulotome 300 of the second embodiment of the present invention is different in that the structure of the driving assembly 30 is different.

[0084] In this embodiment, the structures of the scissor arm 31, the connecting rod 34, and the sliding member 32 are the same as those in the first embodiment. In addition to the sliding member 32, the support member 33 having a hollow inner cavity, and the two connecting rods 34, the driving assembly 30 also includes a transmission member 35, which is movably arranged in the hollow inner cavity of the support member 33, and the transmission member 35 is movably connected to the proximal end of the sliding member 32. Specifically, the transmission member 35 is arranged in the hollow inner cavity of the support member 33 and is threadedly connected to the side wall of the support member 33, and the transmission member 35 is rotatably connected to the proximal end of the sliding member 33. In this way, the sliding member 32 is driven to move by the transmission member 35, the sliding member 32 drives the connecting rod 34 to rotate, and the connecting rod 34 drives the scissor arm 31 to rotate, so that the opening and closing of the scissor arm 31 are controlled by the transmission member 35.

[0085] In the above-mentioned valve cutter 300, when the two scissor arms 31 are in an open state, the blades of the two scissor arms 31 facing each other can cut the valve. On the one hand, since the angle between the two scissor arms 31 when they are opened is less than 180°, the blades are inclined relative to the valve, and the contact between the blades and the valve during the cutting process is similar to point contact, with a small contact area, so the blades can easily cut the valve, and the required pulling force is small; on the other hand, the driving component 30 can control the opening angle of the two scissor arms 31 according to different degrees of valve adhesion to control the cutting range of the valve, so that the cutting is more precise and the problem of incomplete cutting or excessive cutting is avoided.

[0086] It can be understood that the transmission member 35 is threadedly connected to the side wall of the support member 33, the transmission member 35 is provided with an external thread, and the side wall of the support member 33 is provided with an internal thread that matches the external thread. The axial movement of the transmission member 35 is achieved by the rotation between the internal and external threads to move toward the distal end or the proximal end, that is, the transmission member 35 rotates while moving axially, and the sliding member 33 and the transmission member 35 can rotate relative to each other, so that the sliding member 33 does not rotate relative to the support member 33 and can only move axially. The setting of the transmission member 35 is more conducive to the two scissor arms 31 to stably maintain the opening angle under the force state.

[0087] Specifically, a matching pressure ring 321 is provided on the circumference of the sliding member 32, and the sliding member 33 is rotationally connected to the transmission member 35 through the matching pressure ring 321. When the transmission member 35 rotates with the axis as the center line, the transmission member 35 moves axially toward the distal end or the proximal end while rotating. Since the pressure ring 321 is fixedly connected to the distal end of the transmission member 35, but the pressure ring 321 is rotationally connected to the sliding member 32, the sliding member 32 does not rotate but only moves axially.

[0088] Further, the proximal end of the sliding member 32 is provided with a first cylindrical section 322, a second cylindrical section 323 and an annular groove 324 between the first cylindrical section 322 and the second cylindrical section 323. A circular hole 351 is provided at the distal end of the transmission member 35, and the first cylindrical section 322 of the sliding member 32 is slidably penetrated in the circular hole 351, and the pressure ring 321 is clamped in the annular groove 324 and is welded and fixed to the distal end of the transmission member 35. The first cylindrical section 322 of the sliding member 32 and the circular hole 351 of the transmission member 35 can rotate relative to each other, but there is no relative movement or only a small relative movement between the axial directions. In order to ensure the smoothness of the rotation between the sliding member 32 and the transmission member 35, the depth of the circular hole 351 should be greater than the height of the first cylindrical section 322 of the sliding member 32, preferably in the range of 0.01-0.05mm, and the diameter of the circular hole 351 should be greater than the diameter of the first cylindrical section 322, preferably in the range of 0.01-0.05mm. The inner diameter of the pressing ring 321 should be larger than the inner diameter of the annular groove 324, preferably in the range of 0.01-0.05 mm. At the same time, the inner diameter of the pressing ring 321 should also be smaller than the diameter of the first cylindrical section 322 and the diameter of the second cylindrical section 323 to prevent the first cylindrical section 322 or the second cylindrical section 323 from slipping out. The outer diameter of the pressing ring 321 should also be larger than the aperture of the circular hole 351. It is foreseeable that the connection method between the sliding member 32 and the transmission member 35 is not limited to the above method, as long as it can ensure that the two can achieve mutual rotation but no axial relative movement occurs.

[0089] The second embodiment of the present invention further provides a valvulotomy system, including a tube assembly 40 and a valvulotomy device 300. The tube assembly 40 includes an outer tube 41 and an inner tube 42 sleeved in the outer tube 41, and the inner tube 42 can move relative to the outer tube 41. The distal end of the outer tube 41 is fixedly connected to the proximal end of the support member 33, and the distal end of the inner tube 42 is fixedly connected to the proximal end of the transmission member 35. Compared with the valvulotomy system 200 of the first embodiment, the difference of the valvulotomy system of this embodiment is that the distal end of the inner tube 42 is fixedly connected to the proximal end of the transmission member 35.

[0090] The valvulotomy system may further include a handle, the proximal end of the tube assembly 40 is connected to the handle, the distal end of the tube assembly 40 is connected to the drive assembly 30, and the handle is used to control the opening or closing of the two scissor arms 31 through the tube assembly 30. Specifically, the distal end of the inner tube 42 is fixedly connected to the proximal end of the transmission member 35, and the proximal end of the inner tube 42 is connected to a control member (not shown) provided on the handle, such as a sliding structure. In this way, the rotation of the inner tube 42 in the outer tube 41 is controlled by operating the control member on the handle, thereby driving the transmission member 35 to rotate and move axially, so that the sliding member 33 moves axially, thereby driving the two scissor arms 31 to rotate through the connecting rod 34, and realizing the opening and closing of the two scissor arms 31.

[0091] Specifically, when performing surgery, the operating member (not shown) on the operating handle rotates the inner tube 42, and the inner tube 42 drives the transmission member 35 to rotate. Under the cooperation of the inner thread of the support member 33, the transmission member 35 with an outer thread rotates while moving axially toward the distal end, thereby opening the two scissor arms 31; conversely, when rotating in the opposite direction, the two scissor arms 31 will be closed. The threaded connection between the transmission member 35 and the support member 33 can be understood as a locking mechanism, which can eliminate the problem that the opening angle between the two scissor arms 31 cannot be accurately maintained due to the gap between the inner tube 42 and the outer tube 41 or the slight deformation of the inner tube 41 and the outer tube 42.

[0092] Embodiment 3

[0093] See also Figure 21-Figure 27 Compared with the valvulotome 100 of the first embodiment, the valvulotome 500 of the third embodiment of the present invention is different in that the structures of the two scissor arms 51 and the structure of the driving assembly 50 are different.

[0094] In this embodiment, the valvulotome 500 includes two scissor arms 51 and a driving assembly 50 for driving the two scissor arms 51 to rotate. The driving assembly 50 includes a connecting member 52 and a driving member 53. The proximal ends of the two scissor arms 51 are rotatably connected to the connecting member 52. A mounting seat 511 is provided at the proximal end of each scissor arm 51, and at least one driving member 53 is wound around the circumference of the mounting seat 511. In this way, the two scissor arms 51 are driven to rotate relative to the connecting member by the driving member 53, so that the two scissor arms 51 are opened or closed.

[0095] In the above-mentioned valve cutter 500, when the two scissor arms 51 are in an open state, the blades of the two scissor arms 51 facing each other can cut the valve. On the one hand, since the angle between the two scissor arms 51 when they are opened is less than 180°, the blade is inclined relative to the valve, and the contact between the blade and the valve during the cutting process is similar to point contact, with a small contact area, so the blade can easily cut the valve, and the required pulling force is small; on the other hand, the driving component 50 can control the opening angle of the two scissor arms 51 according to different degrees of valve adhesion to control the cutting range of the valve, so that the cutting is more precise and the problem of incomplete cutting or excessive cutting is avoided.

[0096] See also Fig.25 and Fig.26, the mounting seat 511 is also provided with a slot 512, and the driving assembly 50 also includes a fixed block 531 fixedly connected to the driving member 53, and the fixed block 531 is fixed in the slot 512. In this way, the driving member 53 is wound around the circumference of the mounting seat 511 through the fixing cooperation of the fixed block 531 and the slot 512. Specifically, the driving member 53 can be a driving wire, and the mounting seat 511 can be set as a roughly circular mounting seat, and a wire groove 514 is set on the circumference of the mounting seat 511. In this embodiment, the driving assembly 50 includes at least two driving wires, at least one driving wire is correspondingly wound in the wire groove 514, and the width of the wire groove 514 should be slightly larger than the diameter of the driving wire, so that the driving wire can be completely immersed in the wire groove 514. The driving wire is arranged around the wire groove 514 and the two ends respectively pass through the axial wire holes 5211 set on the base 521 and continue to extend until it is connected with the control member on the handle 63.

[0097] Specifically, the drive line can be made of materials with suitable properties including but not limited to stainless steel cables, stainless steel wires, nickel-titanium multi-strand wires, nylon wires, etc. The drive line should have good flexibility, high tensile strength and stiffness. The drive line should not undergo elastic or plastic deformation under large-angle bending, can withstand high tensile forces, and will not deform axially under stress. Preferably, the drive line in this embodiment uses nickel-titanium multi-strand wires.

[0098] The fixing block 531 can be made of a stainless steel sleeve and fixed on the driving line by crimping, welding, bonding, etc. The connection between the fixing block 531 and the driving line should be firm. When the driving line is stressed, the fixing block 531 and the driving line should not move relative to each other. The fixing block 531 can be completely inserted into the card slot 512, and the fixing block 531 and the card slot 512 fit tightly to ensure that when the driving line is pulled, the movement of the scissor arm 51 can respond immediately without lag.

[0099] See also Fig.23 The connecting member 52 includes a base 521 and a second connecting portion 522 provided on the base 521. The proximal ends of the two scissor arms 51 are rotatably connected to the second connecting portion 522, and the driving member 53 passes through the base 521. The proximal ends of the two scissor arms 51 are rotatably connected to the second connecting portion 522 of the connecting member 52 through the fourth connecting member 56. Specifically, the proximal ends of the scissor arms 51 are provided with a seventh connecting hole 513, and the second connecting portion 522 is provided with an eighth connecting hole 523. The fourth connecting member 56 passes through the seventh connecting hole 513 on the two scissor arms 51 and the eighth connecting hole 523 on the second connecting portion 522, and the two scissor arms 51 are rotatably connected to both sides of the second connecting portion 522. The two scissor arms 51 can rotate relative to the second connecting portion 522 around the fourth connecting member 56, thereby realizing the opening and closing of the two scissor arms 51. The fourth connecting member 56 can be a pin or a rivet.

[0100] The third embodiment of the present invention further provides a valvulotomy system, comprising a handle 63 and a valvulotomy device 500. The handle 63 comprises a control member 621, and the control member 621 is used to control the driving member 53 to drive the two scissor arms 51 to rotate simultaneously.

[0101] See also Fig.24 The control member 621 is used to control the driving member 53 to drive the two scissor arms 51 to rotate simultaneously. The control member 621 includes a bevel gear set, which includes a driving gear 622 and two driven gears 623. The two driven gears 623 are respectively meshed with the driving gear 622, and the driving member 53 corresponding to each scissor arm 51 is respectively connected to the two driven gears 623.

[0102] It can be understood that the opening and closing of the two scissor arms 51 are controlled in linkage. The drive assembly 50 includes two drive members 53, i.e., two drive wires, one drive wire is wound around the mounting seat 511 of each scissor arm 51, and the two drive wires are respectively connected to two driven gears 623. In this way, the two driven gears 623 can be driven to rotate simultaneously by the driving gear 622, and then the two scissor arms 51 can be driven to rotate simultaneously by the two drive wires. Further, the control member 621 also includes a knob 625, which is connected to the driving gear 622, and the driving gear 622 can be rotated by turning the knob 625. The valvulotomy system also includes a tubular body assembly 610, which includes an outer tube 612 and an inner tube 613, and the outer tube 612 and the inner tube 613 are both fixedly connected to the handle 63, and there is no relative movement between the outer tube and the inner tube and the handle 63.

[0103] Specifically, the two driven gears 623 are respectively meshed with the driving gear 622, and the axes of the two driven gears 622 are perpendicular to the axis of the driving gear 622. The shaft of the driving gear 622 is fixedly connected to the knob 625, the driven gears 622 are respectively connected to the two terminals 624, and the two driving wires pass through the tube assembly 610 to the handle 63 and are respectively connected to the two terminals 624. In this way, the active gear 622 can be driven to rotate by turning the knob 625, and the two driven gears 622 meshing therewith can be driven to rotate simultaneously in opposite directions, which will then control the two driving wires fixedly connected to the terminal 624 to pull the corresponding fixing blocks 531 in opposite directions, and the two scissor arms 51 will rotate relative to the connecting member 52 along with the movement of the driving wires under the drive of the corresponding driving wires and the fixing blocks 531, thereby opening the two scissor arms 51. Since the two driving wires make the mounting bases 511 of the two scissor arms 51 rotate in opposite directions, the two scissor arms 51 will rotate in opposite directions, thereby realizing the function of opening the scissor arms 51 at the same time and to the same extent. Conversely, when the knob is turned in the opposite direction, the two scissor arms 51 can be driven to close.

[0104] Continue reading Fig.24, the opening angle d of the two scissor arms 51 should be between 0-170°. When the opening angle d reaches the maximum value of 170°, the maximum cutting length g of the two scissor arms 51 is in the range of 28-30 mm. Of course, the structure of the linkage control is not limited to the structural scheme listed in this embodiment, which is mainly realized by mutually meshing gears, and the arrangement is not limited to this.

[0105] Embodiment 4

[0106] See also Fig.28 Compared with the valvulotome 500 of the third embodiment, the valvulotome of the fourth embodiment of the present invention is different in that the opening and closing of the two scissor arms 71 are controlled separately.

[0107] In the fourth embodiment of the present invention, the two scissor arms 71 can be controlled separately, so as to achieve different opening angles of the two scissor arms 71. Since the parts causing valve stenosis are often asymmetrically distributed, different cutting degrees should be required on both sides of the valve, that is, the two scissor arms 71 should have different opening angles relative to the central axis of the valvulotome. The separately controlled scissor arms 71 can set the opening angles of the scissor arms 71 on both sides according to the actual physiological and anatomical structure of the valve, so as to accurately and controllably control the two sides to have different cutting ranges, which can adapt to the asymmetric situation of valve stenosis and avoid the situation where one side of the valve is overcut and the other side is not cut in place.

[0108] A fourth embodiment of the present invention further provides a valvulotomy system, comprising a handle and a valvulotomy device 700 , wherein the handle comprises a control member, and the control member is used to control a driving member to drive two scissor arms 71 to rotate respectively.

[0109] See also Fig.28 The control member is used to control the driving member to drive the two scissor arms to rotate respectively. The control member includes two bevel gear sets, each bevel gear set includes a driving gear and a driven gear meshing with each other, and the driving member corresponding to each scissor arm 71 is connected to a driven gear.

[0110] It can be understood that the opening and closing of the two scissor arms 71 are controlled separately. The driving assembly includes two driving members, namely two driving wires. A driving wire is wound around the mounting seat of each scissor arm 71. The two driving wires are respectively connected to two driven gears, and the two driven gears are respectively connected to two driving gears. In this way, the driving gears can be controlled to drive the driven gears to rotate, and then the scissor arms 71 can be driven to rotate separately through the driving wires. Furthermore, the control member also includes two knobs, which are connected to the driving gears in a one-to-one correspondence, and the driving gears can be rotated by turning the knobs.

[0111] Specifically, the two drive lines can be connected to two independent bevel gear sets provided on the handle, each bevel gear set is similar to Fig. 27The bevel gear set in the valve is not related to each other and is not affected by each other. Of course, the independent control member is not limited to the gear mechanism and can also be other mechanisms. The important thing is that the two drive lines can be controlled independently. During the surgical operation, according to the actual physiological and anatomical structure of the valve, the corresponding control member can be used to independently control the scissor arm 71 on one side to open to a suitable angle e, and then the control member is locked to fix the scissor arm 71, and then the other control member is operated to independently control the scissor arm 71 on the other side to open to a suitable angle f, and then the other control member is locked to fix the other scissor arm 71 to maintain the angle. The two scissor arms 71 form different angles f and e with the central axis of the valve cutter, so that the blades on the two scissor arms 71 have different maximum cutting lengths.

[0112] It can be understood that the above embodiments only express the preferred implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the patent scope of the present invention. It should be pointed out that, for ordinary technicians in this field, the above technical features can be freely combined without departing from the concept of the present invention, and several deformations and improvements can be made, which all belong to the protection scope of the present invention. Therefore, all equivalent changes and modifications made to the scope of the claims of the present invention should belong to the coverage of the claims of the present invention.

Claims

1. A valvulotome, characterized in that: include: Two scissor arms and a driving assembly connecting the two scissor arms, the two scissor arms are connected in a cross-rotating manner, a blade is provided on a side of each scissor arm facing away from the other scissor arm, and the driving assembly is used to drive the two scissor arms to open or close; When the two scissor arms are in an open state, the angle between the two scissor arms is less than 180°; when the two scissor arms are in a closed state, the two scissor arms are substantially overlapped; the distal end of the scissor arm is an arc-shaped structure; The driving assembly comprises: a sliding member, a support member having a hollow inner cavity and two connecting rods, the two scissor arms are rotatably connected to the distal end of the support member through a first connecting member, the distal ends of the two connecting rods are rotatably connected to the proximal ends of the two scissor arms respectively, the proximal ends of the two connecting rods are rotatably connected to the distal end of the sliding member, and the sliding member is slidably arranged in the hollow inner cavity of the support member; or, The driving assembly includes a connecting member and a driving member, the proximal ends of the two scissor arms are rotatably connected to the connecting member via a fourth connecting member, a mounting seat is provided at the proximal end of each of the scissor arms, and the circumferential side of the mounting seat is wrapped around at least one of the driving members; the mounting seat is also provided with a slot, and the driving assembly also includes a fixing block fixedly connected to the driving member, and the fixing block is fixed in the slot.

2. The valvulotome according to claim 1, characterized in that: The side wall of the support member is provided with two opposite movable grooves, the two connecting rods are respectively arranged in the movable grooves, and the two scissor arm parts are arranged in the movable grooves.

3. The valvulotome according to claim 1, characterized in that: The sliding member comprises a platform and a first connecting portion arranged at the distal end of the platform, the platform matches with the side wall of the supporting member, and the proximal ends of the two connecting rods are rotatably connected to the first connecting portion.

4. The valvulotome according to claim 1, characterized in that: The scissor arm comprises a first boss, which is arranged at the connection between the scissor arm and the support member; and / or the connecting rod comprises a second boss, which is arranged at the connection between the connecting rod and the scissor arm.

5. The valvulotome according to claim 1, characterized in that: The driving assembly further comprises a transmission member, which is movably disposed in the hollow inner cavity of the supporting member and is movably connected to the proximal end of the sliding member.

6. The valvulotome according to claim 5, characterized in that: The transmission member is disposed in the hollow inner cavity of the support member and is threadedly connected to the side wall of the support member. The transmission member is rotationally connected to the proximal end of the sliding member.

7. The valvulotome according to claim 1, characterized in that: The connecting member comprises a base and a second connecting portion arranged at the distal end of the base, the proximal ends of the two scissor arms are rotatably connected to the second connecting portion, and the driving member passes through the base.

8. A valvulotomy system, characterized in that: It comprises: a tube body assembly, a handle, and the valvulotome according to any one of claims 1 to 7, wherein the proximal end of the tube body assembly is connected to the handle, the distal end of the tube body assembly is connected to the drive assembly, and the handle is used to control the opening or closing of the two scissor arms through the tube body assembly.

9. A valvulotomy system, characterized in that: include: A tube body assembly and a valvulotome as described in any one of claims 1 to 4, wherein the tube body assembly comprises an outer tube and an inner tube sleeved in the outer tube, the inner tube being movable relative to the outer tube, the distal end of the outer tube being fixedly connected to the proximal end of the support member, and the distal end of the inner tube being fixedly connected to the proximal end of the sliding member.

10. A valvulotomy system, characterized in that: include: A tube body assembly and a valvulotome as described in claim 5 or 6, wherein the tube body assembly comprises an outer tube and an inner tube sleeved in the outer tube, the inner tube can move relative to the outer tube, the distal end of the outer tube is fixedly connected to the proximal end of the support member, and the distal end of the inner tube is fixedly connected to the proximal end of the transmission member.

11. A valvulotomy system, characterized in that: It comprises a handle and the valvulotome according to claim 7, wherein the handle comprises a control member, and the control member is used to control the driving member to drive the two scissor arms to rotate separately or simultaneously.

12. The valvulotomy system according to claim 11, characterized in that: The control member is used to control the driving member to drive the two scissor arms to rotate simultaneously. The control member includes a bevel gear set, and the bevel gear set includes a driving gear and two driven gears. The two driven gears are respectively meshed with the driving gear, and the driving member corresponding to each scissor arm is respectively connected to the two driven gears.

13. The valvulotomy system according to claim 11, characterized in that: The control member is used to control the driving member to drive the two scissor arms to rotate respectively. The control member includes two bevel gear sets, each of which includes a driving gear and a driven gear that mesh with each other. The driving member corresponding to each scissor arm is connected to one of the driven gears.

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