Artificial chordae tendineae implantation device

Abstract

This application provides an artificial chordae tendineae implantation device, comprising a leaflet capturing assembly and an artificial chordae tendineae implantation assembly. The leaflet capturing assembly includes a first clamping member, a second clamping member, and a transmission assembly. Driven by the transmission assembly, the second clamping member can open relative to the first clamping member to form an angle, or close to capture and clamp the leaflet of a valve between the first and second clamping members. One of the first and second clamping members has a protruding convex component, and the other has a groove. When the first and second clamping members are closed relative to each other and the leaflet is not located between the convex component and the groove, the convex component is received in the groove. The artificial chordae tendineae implantation assembly includes a puncture needle and a pushable artificial chordae tendineae housed within the puncture needle. After the leaflet capturing assembly captures and clamps the leaflet, the puncture needle punctures the leaflet, and the artificial chordae tendineae is pushed to the other side of the leaflet. After the artificial chordae tendineae is pushed to the other side of the leaflet, the leaflet capturing assembly separates from the leaflet and withdraws.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an artificial chordae tendineae implantation device. Background Technology

[0002] The mitral and tricuspid valves, among others, are one-way valves in the heart. Normal, healthy atrioventricular valves control the flow of blood from the atria to the ventricles while preventing blood from flowing from the ventricles to the atria. For example: Figure 1 As shown, the mitral valve MV is a one-way valve located between the left atrium LA and the left ventricle LV. It controls the flow of blood from the left atrium LA to the left ventricle LV, while preventing blood from flowing from the left ventricle LV to the left atrium LA. The tricuspid valve TV is a one-way valve located between the right atrium RA and the right ventricle RV. It controls the flow of blood from the right atrium RA to the right ventricle RV, while preventing blood from flowing from the right ventricle RV to the right atrium RA.

[0003] Please see Figure 2 A normal, healthy mitral or tricuspid valve has multiple chordae tendineae (L). Taking the mitral valve as an example, the valve leaflets are divided into anterior and posterior leaflets. When the left ventricle is in diastole, both leaflets are open, and blood flows from the left atrium to the left ventricle. When the left ventricle is in systole, the chordae tendineae are stretched, ensuring that the leaflets are not pushed to the atrial side by the blood flow. The anterior and posterior leaflets close well, thus ensuring that blood flows from the left ventricle through the aortic valve to the aorta. If the chordae tendineae or papillary muscles are diseased, for example... Figure 3 As shown, when the posterior leaflet of the chordae tendineae is ruptured, the mitral valve cannot return to its closed state as it would normally when the left ventricle is in a state of contraction. The force of the blood flow will further cause the leaflet to dislodge into the left atrium, resulting in blood regurgitation.

[0004] Once chordae tendineae become diseased or ruptured, they cannot repair themselves. Even if only a few chordae tendineae rupture, the increased tension on other chordae tendineae can lead to new ruptures. Currently, artificial chordae tendineae are usually implanted surgically to replace the original ones. This requires invasive open-chest techniques and general anesthesia with moderate hypothermic cardiopulmonary bypass as support. This type of surgery has drawbacks such as complex procedures, high costs, significant patient trauma, high risk of complications, long hospital stays, and painful recovery processes.

[0005] There is a device for implanting artificial chordae tendineae via a minimally invasive procedure. This device uses distal and proximal clamps to hold the leaflets. During leaflet capture, the clamping surface of the capture clamps is at a fixed, non-adjustable angle, making leaflet capture difficult, cumbersome, and increasing the risk of surgical failure. Furthermore, after the capture clamps hold the leaflets, they need to be withdrawn axially to retain them. However, with the leaflets bouncing, the capture clamps are prone to separating from the leaflets, making capture difficult. Additionally, the capture clamps are in a "barbed" shape during withdrawal, increasing the risk of snagging the chordae tendineae and leaflets during the withdrawal process, thus affecting the implantation procedure. Summary of the Invention

[0006] The technical problem to be solved by this application is to provide an artificial chordae tendineae implantation device that changes the existing methods of leaflet capture and puncture during artificial chordae tendineae implantation.

[0007] To achieve the above objectives, the embodiments of this application adopt the following technical solutions:

[0008] An artificial chordae tendineae implantation device, comprising:

[0009] A leaflet capturing assembly includes a first clamping member, a second clamping member, and a transmission assembly. Driven by the transmission assembly, the second clamping member can open relative to the first clamping member to form an angle, or close to capture and clamp a leaflet of the valve between the first and second clamping members. One of the first and second clamping members has a protruding convex component, and the other has a groove. When the first and second clamping members are closed relative to each other and the leaflet does not fall between the convex component and the groove, the convex component is received in the groove.

[0010] An artificial chordae tendineae implantation assembly includes a puncture needle and a pushable artificial chordae tendineae housed within the puncture needle. After the leaflet capture assembly captures and clamps the leaflet, the puncture needle punctures the leaflet, and the artificial chordae tendineae ...

[0011] In a preferred embodiment, the opposing surfaces of the first clamping member and the second clamping member are provided with clamping areas and non-clamping areas. At least one of the clamping areas is provided with clamping teeth to clamp the leaflet between the two clamping areas. When the first clamping member and the second clamping member are closed relative to each other, there is a gap between the non-clamping areas of the first clamping member and the second clamping member to accommodate a portion of the leaflet that is not clamped. The gap is between 0.5-2 mm.

[0012] In a preferred embodiment, the first clamping member and the second clamping member are respectively provided with connecting portions, the connecting portions being located on the side of the clamping area away from the non-clamping area, the connecting portion of the second clamping member being hinged to the connecting portion of the first clamping member, and one end of the transmission assembly being connected to the connecting portion of the second clamping member to drive the second clamping member to open and close relative to the first clamping member.

[0013] In a preferred embodiment, the first clamping member is provided with a transmission channel, the transmission channel is connected to the clamping area of ​​the first clamping member and extends to the connecting portion, the transmission assembly includes a transmission shaft and a transmission connector, the transmission shaft is movably housed in the transmission channel, one end of the transmission connector is pivotally connected to the second clamping member via a first pivot shaft, and the other end of the transmission connector is movably housed in the transmission channel and pivotally connected to one end of the transmission shaft via a second pivot shaft.

[0014] In a preferred embodiment, the first clamping member is a block-shaped base, the second clamping member is a sheet-shaped cover, the connecting portion of the second clamping member has two ribs arranged at relative intervals, the ends of the two ribs away from the clamping area are hinged to both sides of the connecting portion of the first clamping member by a pivot shaft, and the ends of the two ribs near the clamping area are pivotally connected to the transmission connecting member by the first pivot shaft.

[0015] In a preferred embodiment, both the first clamping member and the second clamping member have a plurality of clamping teeth in their clamping areas, and there is a tooth groove between two adjacent clamping teeth. When the first clamping member and the second clamping member are not clamping the leaflets and are relatively closed, the clamping teeth of the first clamping member engage with the tooth groove of the second clamping member. The plurality of clamping teeth extend laterally from one side of the clamping area to the other side of the clamping area. The transmission channel has an opening in the clamping area of ​​the first clamping member, and the opening interrupts part of the clamping teeth of the first clamping member.

[0016] In a preferred embodiment, the convex component is disposed between the clamping area and the connecting portion of one of the first clamping member and the second clamping member, and the groove is disposed between the clamping area and the connecting portion of the other of the first clamping member and the second clamping member. The height of the convex component is higher than the height of the clamping teeth. When the first clamping member and the second clamping member are relatively closed and the leaflets fall between the convex component and the groove, the convex component fails to be accommodated in the groove, so that the first clamping member and the second clamping member cannot be completely closed.

[0017] In a preferred embodiment, the convex component is disposed on the second clamping member, the groove is disposed on the first clamping member, and the transmission channel interrupts the groove.

[0018] In a preferred embodiment, the convex component is disposed on the first clamping member, and the convex component includes two, with the two convex components respectively located on both sides of the transmission channel. The groove is disposed on the second clamping member, and the groove includes two, with the two grooves corresponding to the two convex components.

[0019] In a preferred embodiment, the connection between the transmission channel and the connecting portion has a limiting boss, which is used to limit the transmission connector to restrict the maximum opening angle of the second clamping piece relative to the first clamping piece. The transmission channel includes a curved section, and the limiting boss is located at the end position of the curved section at the connecting portion. The transmission connector includes a curved portion and a straight portion connecting the curved portion. The curved portion has a rounded corner near the bottom surface of the curved section, and the curved portion has an arc surface away from the curved section. The surface of the straight portion connecting the arc surface is a straight surface. At least a portion of the arc surface is located in the second clamping piece, and at least a portion of the straight portion is located in the first clamping piece.

[0020] In a preferred embodiment, the non-clamping areas of the first clamping member and the second clamping member are respectively inclined relative to the clamping area, and the non-clamping areas of the first clamping member and the second clamping member are parallel to each other. The first clamping member is provided with a guide groove, which is connected to the non-clamping area of ​​the first clamping member. The non-clamping area of ​​the second clamping member is provided with a limiting groove that penetrates the second clamping member and is open at one end. The limiting groove is aligned with and lower than the guide groove. The puncture needle passes through the guide groove and punctures the leaflet in the limiting groove.

[0021] In a preferred embodiment, the non-clamping areas of the first clamping member and the second clamping member have an inclination angle A relative to the corresponding clamping areas. The guide groove includes an inclined segment adjacent to the non-clamping area of ​​the first clamping member. The inclined segment has an inclination angle B relative to the inclined starting point of the guide groove in the first clamping member. The angle C of the puncture needle puncturing the valve leaf satisfies C = A + B, and the angle C of the puncture needle puncturing the valve leaf is between 45 and 90 degrees.

[0022] In a preferred embodiment, the surface of the first clamping member opposite to the second clamping member has an open groove, which is used to observe the connection status between the drive shaft and the drive connector.

[0023] In a preferred embodiment, the first clamping member is further provided with an imaging channel, which is connected to the non-clamping area and is used to introduce contrast agent. The imaging channel is located below the guide groove.

[0024] In a preferred embodiment, when the leaflet is not clamped between the first clamp and the second clamp and the contrast agent flowing out of the angiography channel is observed under medical imaging, the angiography channel is further used as a blood aspiration channel.

[0025] In a preferred embodiment, the artificial tendon is a suture, the suture comprising two suture segments, the suture segments being knotted and threaded onto a pad, the suture segments together with the pad being pushed to the other side of the leaflet via the puncture needle.

[0026] In a preferred embodiment, the end of the first clamping member away from the second clamping member has a cylindrical end and a connector. The non-clamping area of ​​the first clamping member is formed on the side of the cylindrical end facing the second clamping member, and the connector is formed on the other side of the cylindrical end. The guide groove, the transmission channel, and the imaging channel extend from the connector through the cylindrical end toward the non-clamping area. The guide groove is open at the connector, and the connector is used to connect to the delivery conduit.

[0027] The artificial chordae tendineae implantation device provided by this invention has the following beneficial effects:

[0028] One of the clamping members of the leaflet capturing assembly of the artificial chordae tendineae implantation device can open relative to the other to form an angle or close to clamp the leaflet between the two. The relative opening angle of the two clamping members can be controlled and adjusted, and they can reopen relative to each other if the clamping position is not appropriate. The cooperation between the convex component and the groove can be used to detect whether the leaflet is clamped in the appropriate position. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the mitral and tricuspid valves in their normal state.

[0030] Figure 2 This is a schematic diagram of normal chordae tendineae in the heart;

[0031] Figure 3 This is a schematic diagram of a ruptured chordae tendineae in the heart;

[0032] Figure 4 This is a partial schematic diagram of the artificial tendon chord implantation device provided in the first embodiment of the present invention;

[0033] Figure 5 yes Figure 4 A schematic diagram of the second clamp of the leaflet capture assembly of an artificial chordae tendineae implantation device being opened relative to the first clamp;

[0034] Figure 6 yes Figure 5 An explosion diagram;

[0035] Figure 7 yes Figure 6 An enlarged schematic diagram of the first clamping component;

[0036] Figure 8 yes Figure 6 An enlarged schematic diagram of the second clamping component;

[0037] Figure 9 yes Figure 6 An enlarged schematic diagram of the transmission components in the diagram;

[0038] Figure 10 yes Figure 7 A schematic diagram of the back plane of the first clamping member;

[0039] Figure 11 yes Figure 4 A schematic diagram illustrating the length and gap of the non-clamping area of ​​the leaflet capture component in an artificial chordae tendineae implantation device;

[0040] Figure 12 yes Figure 4 A schematic diagram showing the length of the clamping area of ​​the leaflet capture assembly in an artificial chordae tendineae implantation device;

[0041] Figure 13 yes Figure 4 A partial top view of the artificial tendon cord implantation device;

[0042] Figure 14 yes Figure 4 A schematic diagram showing the puncture angle of the puncture needle and the tilt angle of the non-clamping area of ​​the first clamping element in the artificial chordae tendineae implantation device.

[0043] Figure 15 yes Figure 14 A cross-sectional view of the first clamping member along the central axis of the guide groove;

[0044] Figure 16 yes Figure 7 Another angle view of the first clamping component;

[0045] Figure 17 yes Figure 4 A schematic diagram of the delivery catheter for an artificial chordae tendineae implantation device;

[0046] Figure 18 yes Figure 4 A schematic diagram of an artificial chordae tendineae implantation device containing an operating handle;

[0047] Figure 19 yes Figure 18 A partial sectional view of the artificial chordae tendineae implantation device at the operating handle;

[0048] Figure 20 yes Figure 18A schematic diagram of the artificial chordae tendineae implantation device after removing the housing, operating buttons, and artificial chordae tendineae implantation components from the operating handle;

[0049] Figure 21 yes Figure 20 A partial cross-sectional view of the puncture needle of the artificial chordae tendineae implantation device extending further into the leaflet capture assembly;

[0050] Figure 22 This is a partial three-dimensional schematic diagram of the artificial tendon chord implantation device provided in the second embodiment of the present invention;

[0051] Figure 23 yes Figure 22 A three-dimensional enlarged schematic diagram of the first clamping component;

[0052] Figure 24 yes Figure 22 A three-dimensional enlarged schematic diagram of the second clamping component;

[0053] Figure 25 yes Figure 22 A schematic diagram of the artificial chordae tendineae implantation device in the state where the second clamping member is closed relative to the first clamping member when the leaflet is not clamped;

[0054] Figure 26 This is a schematic diagram of the artificial chordae tendineae implantation device provided in an embodiment of the present invention, in which the first and second bending sheaths are loaded to deliver the leaflet capture assembly to the heart tissue;

[0055] Figure 27 yes Figure 26 A schematic diagram of the second clamping member of the leaflet capture assembly of an artificial chordae tendineae implantation device being opened relative to the first clamping member to form a clamping angle;

[0056] Figure 28 yes Figure 27 A schematic diagram showing the alignment of the leaflet capture assembly of an artificial chordae tendineae implantation device with the leaflet.

[0057] Figure 29 yes Figure 28 A schematic diagram showing the leaflet capture assembly of an artificial chordae tendineae implantation device holding the leaflet in place.

[0058] Figure 30 yes Figure 28 An enlarged schematic diagram of an artificial chordae tendineae implantation device as the leaflets initially fall between the leaflet capture components;

[0059] Figure 31 yes Figure 29 An enlarged schematic diagram of an artificial chordae tendineae implantation device puncturing the leaflet after the leaflet capture assembly has closed. Detailed Implementation

[0060] To make the objectives, technical solutions, and advantages of this application clearer, the application will now be described in further detail with reference to the accompanying drawings.

[0061] It should be understood that expressions such as “comprising” and “may include” used in this application indicate the existence of the disclosed functions, operations, or constituent elements, and do not limit one or more additional functions, operations, and constituent elements. In this disclosure, terms such as “comprising” and / or “having” are to be interpreted as indicating a particular characteristic, number, operation, constituent element, component, or combination thereof, but not to exclude the existence or possibility of adding one or more other characteristics, numbers, operations, constituent elements, components, or combinations thereof.

[0062] Furthermore, in this application, the expression "and / or" includes any and all combinations of the associated listed words. For example, the expression "A and / or B" may include A, may include B, or may include both A and B.

[0063] In this application, expressions including ordinal numbers such as "first" and "second" may modify the elements. However, such elements are not limited by the foregoing expressions. For example, the foregoing expressions do not limit the order and / or importance of the elements. The foregoing expressions are only used to distinguish one element from other elements. Similarly, without departing from the scope of this disclosure, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element.

[0064] When a component is referred to as "connected" or "accessed" to other components, it should be understood that this component not only connects directly to or accesses other components, but also that another component may exist between this component and other components. On the other hand, when a component is referred to as "directly connected" or "directly accessed" to other components, it should be understood that no component exists between them.

[0065] In the field of interventional medical device technology, the direction closer to the operator is generally defined as proximal, and the direction farther from the operator is defined as distal. The direction of the rotational axis of objects such as cylinders and tubes is defined as the axial direction. The circumferential direction is the direction around the axis of the object such as cylinders and tubes (perpendicular to the axis and also perpendicular to the cross-sectional radius).

[0066] Please see Figure 4 and Figure 5The artificial chordal implantation device 100 provided in the first embodiment of this application includes a leaflet capturing assembly 10 and an artificial chordal implantation assembly 20. The leaflet capturing assembly 10 includes a first clamping member 11, a second clamping member 12, and a transmission assembly 13. Through the transmission assembly 13, the second clamping member 12 can open at a certain angle relative to the first clamping member 11, or close to capture and clamp the leaflet between the first clamping member 11 and the second clamping member 12.

[0067] In this embodiment, the first clamping member 11 is a block-shaped base, and the second clamping member 12 is a sheet-like structure covering the first clamping member 11. One end of the first clamping member 11 is connected to the delivery conduit 16. The second clamping member 12 is hinged to the first clamping member 11. The transmission assembly 13 is located between the first clamping member 11 and the second clamping member 12, and one end of the transmission assembly 13 is connected to the second clamping member 11, while the other end can move within the first clamping member 11.

[0068] Specifically, please refer to the following: Figures 6 to 9 The first clamping member 11 has a connecting portion 112, a clamping area 114, and a non-clamping area 116 respectively, extending from the distal end away from the operator to the proximal end closer to the operator; the second clamping member 12 has a connecting portion 122, a clamping area 124, and a non-clamping area 126 respectively, extending from the distal end away from the operator to the proximal end closer to the operator. The clamping area 114 of the first clamping member 11 faces the clamping area 124 of the second clamping member 12, and the non-clamping area 116 of the first clamping member 11 faces the non-clamping area 126 of the second clamping member 12. When the first clamping member 11 and the second clamping member 12 are relatively closed, there is a gap between the non-clamping areas 126 of the first clamping member 11 and the second clamping member 12 (see...). Figure 11 ).

[0069] At least one of the clamping area 114 of the first clamping member 11 and the clamping area 116 of the second clamping member 12 is provided with clamping teeth to provide clamping force to the leaflets. In this embodiment, the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12 are respectively provided with clamping teeth, and there is a tooth groove between two adjacent clamping teeth. When the first clamping member 11 and the second clamping member 12 are closed relative to each other, the clamping teeth 110 of the first clamping member 11 engage with the tooth groove 121 of the second clamping member 12, and the tooth groove 111 of the first clamping member 11 engages with the clamping teeth 120 of the second clamping member 12.

[0070] The clamping teeth 110 of the first clamping member 11 and the clamping teeth 120 of the second clamping member 12 are arranged side by side laterally along the surface of the clamping area, and both extend from one side of the clamping area to the other side.

[0071] The connecting portion 122 of the second clamping member 12 has two ribs 122a arranged at intervals. The connecting portion 112 of the first clamping member 11 is block-shaped. The ends of the two ribs 122a furthest from the clamping area 124 have shaft holes 122d, which are then hinged to the shaft holes 112a on both sides of the connecting portion 112 of the first clamping member 11 via a pivot 122b. Thus, the second clamping member 12 can rotate relative to the first clamping member 11 to open or close relative to it. The two ribs 122a each have a certain inclination relative to the clamping area 124 towards the first clamping member 11. The two sides of the connecting portion 112 of the first clamping member 11 each have inclined support portions 112b. When the first clamping member 11 and the second clamping member 12 are not clamping the leaflets and are closed relative to each other, the two ribs 122a are precisely accommodated on the support portions 112b, making the entire leaflet capturing assembly 10 smaller in size.

[0072] The first clamping member 11 has a transmission channel 115 extending from the proximal end to the distal end. The transmission channel 115 communicates with the clamping area 114 and has an opening in the clamping area 114 that extends to the connecting portion 112, interrupting a portion of the clamping teeth 110. The transmission channel 115 includes a curved segment 115b near the distal end and a straight segment 115a connecting the curved segment 115b and near the proximal end. The curved segment 115b is composed of an arc segment, or a diagonal segment, or a combination of an arc segment and a diagonal segment. The curved segment 115b is inclined upward relative to the straight segment 115a toward the second clamping member 12.

[0073] The transmission assembly 13 includes a transmission shaft 132 and a transmission connector 134. The transmission shaft 132 is movably housed in the transmission channel 115. Specifically, its first end is located within the transmission channel 115 of the first clamping member 11, and its opposite second end extends beyond the proximal end of the first clamping member 11. The portion of the transmission shaft 132 extending beyond the proximal end of the first clamping member 11 is fitted with a spring tube 132b to allow the transmission shaft 132 to move undisturbed within the spring tube 132b.

[0074] The first end of the transmission connector 134 is pivotally connected to the second clamping member 12 on the first pivot shaft 134a, and the opposite second end is movably accommodated in the transmission channel 115, and is pivotally connected to the first end of the transmission shaft 132 through the shaft hole 132a on the second pivot shaft 134b. (See also...) Figure 10 The first clamping member 11 has an open groove 130 on its surface opposite to the second clamping member 12. The open groove 130 is used to observe the connection status between the transmission shaft 132 and the transmission connector 134, including whether it is connected in place and whether there are any abnormalities.

[0075] Since the connecting portion 122 of the second clamping member 12 consists of two relatively spaced ribs 122a, the first end of the transmission connector 134 is provided with a connecting post 134c. The connecting post 134c has a shaft hole 134d inside, and is then pivotally connected to the shaft hole 122c at the end of the two ribs 122a near the clamping area 124 via a first pivot shaft 134a. The second end of the transmission connector 134 is pivotally connected to the first end of the transmission shaft 132 via a second pivot shaft 134b. Here, "pivot" refers to at least one relative pivot shaft between two pivotally connected objects having a degree of rotational freedom. In this embodiment, the transmission connector 134 can rotate around the first pivot shaft 134a and the second pivot shaft 134b. Both the first pivot shaft 134a and the second pivot shaft 134b can be pins, and the second clamping member 12, the transmission connector 134, and the transmission shaft 132 are wound around the pins with shaft holes. The transmission shaft 132 drives the transmission connector 134 to move. The movement of the transmission connector 134 causes the second clamping member 12 to rotate around the hinged first clamping member 11, thereby opening and closing relative to the first clamping member 11. Thus, the transmission assembly 13 also becomes the opening and closing control element of the leaf capture assembly 10.

[0076] The transmission connector 134 includes a curved portion 134a and a straight portion 134e connecting the curved portion 134a. The bottom surface of the curved section 115b of the curved portion 134a near the transmission channel 115 has a rounded corner 134c. The surface of the curved portion 134a facing away from the curved section 115b has an arc surface 134d. The arc surface 134d bends from the connecting post 134c. Since the connecting post 134c is connected to the second clamping member 12, at least a portion of the arc surface 134d is located in the second clamping member 12. The upper surface 134f of the straight portion 134e connecting to the arc surface 134d is a straight surface, and the lower surface connecting to the rounded corner 134c is also a straight surface. At least a portion of the straight section 134e is located on the first clamping member 11, and as the transmission assembly 13 moves, at least a portion of the straight section 134e moves on the straight section 115a of the transmission channel 115. Since the curved section 115b of the transmission channel 115 is inclined upward relative to the straight section 115a toward the second clamping member 12, at least a portion of the curved section 134a is located between the first clamping member 11 and the second clamping member 12.

[0077] In this embodiment, a limiting boss 115d is formed at the point where the curved segment 115b of the transmission channel 115 connects to the connecting portion 112, i.e., at the end point of the curved segment 115b. The limiting boss 115d is designed such that when the second clamping piece 12 is opened to its maximum angle relative to the first clamping piece 11, the limiting boss 115d precisely limits the transmission connector 134. That is, at this point, the driving device of the transmission shaft 132 can no longer drive the transmission shaft 132 and its connected transmission connector 134 across the limiting boss 115d. At this time, the rounded corner 134c of the bottom surface of the curved portion 134a can be exactly tangent to the edge line of the limiting boss 115d. The maximum opening angle of the second clamping piece 12 relative to the first clamping piece 11 can be 60 degrees, or it can be designed to open to 90 degrees. Typically, for clamping a single leaflet, the second clamping piece 12 only needs to open to 60 degrees relative to the first clamping piece 11.

[0078] The non-clamping area 116 of the first clamping member 11 is generally an inclined surface, tilting from the clamping area 114 towards the proximal end; the non-clamping area 126 of the second clamping member 12 is also generally an inclined surface, tilting from the clamping area 124 towards the proximal end, and the non-clamping area 116 of the first clamping member 11 faces and is parallel to the non-clamping area 126 of the second clamping member 12. In other embodiments, the non-clamping areas 116 and 126 may also be partially tilted and parallel.

[0079] Please see Figure 11 and Figure 12 The length L31 of the clamping area 114 of the first clamping member 11 from distal to proximal end and the length L32 of the clamping area 124 of the second clamping member 12 from distal to proximal end are both between 3 and 5 mm. The lengths L31 and L32 of the clamping area 114 and 124 can be equal or unequal. The lengths L11 of the non-clamping area 116 of the first clamping member 11 from distal to proximal end and the lengths L12 of the non-clamping area 126 of the second clamping member 12 from distal to proximal end are both between 2 and 5 mm. The length L12 of the non-clamping area 126 can be slightly larger than the length L11 of the non-clamping area 116, so that when the second clamping member 12 is closed on the surface of the first clamping member 11, the top of the non-clamping area 126 is higher than the top of the non-clamping area 116. This helps prevent the movable second clamping member 12 from being moved open by the conveying sheath during the conveying process. The gap L2 between the non-clamping area 116 of the first clamping member 11 and the non-clamping area 126 of the second clamping member 12, i.e. the gap L2 between the inclined surfaces, is between 0.5-2mm to accommodate the thickness of the heart valve leaflet.

[0080] When the first clamping member 11 and the second clamping member 12 are closed, they have a clamping force on the leaflets. The clamping teeth 110 of the first clamping member 11 and the clamping teeth 120 of the second clamping member 12 make the clamping more stable. The non-clamping area 116 of the first clamping member 11 and the non-clamping area 126 of the second clamping member 12 do not have a clamping force on the leaflets, but they have a certain supporting effect.

[0081] In this embodiment, please refer again. Figure 8 The second clamping member 12 has a protruding convex component 125 between the clamping area 124 and the connecting portion 122. The height of the convex component 125 is higher than the height of the clamping teeth 120. A groove 119 is provided between the clamping area 114 and the connecting portion 112 of the first clamping member 11. The transmission channel 115 interrupts the groove 119 at the opening of the clamping area 114. When the first clamping member 11 and the second clamping member 12 are not clamping the leaflets and are relatively closed, the convex component 125 is received in the groove 119. When there are leaflets between the convex component 125 and the groove 119, the first clamping member 11 and the second clamping member 12 cannot be completely closed. Thus, the convex component 125 can serve as a detection marker to check whether the leaflets are clamped in the appropriate position. For example, if the first clamping member 11 and the second clamping member 12 cannot be closed, it may be due to excessive leaflets accumulating between the convex component 125 and the groove 119. In this case, the first clamping member 11 and the second clamping member 12 of the leaflet capturing assembly 10 can be reopened, allowing the leaflets to fall primarily between the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12. The accumulation of excessive leaflets between the convex component 125 and the groove 119 can also be observed through medical imaging of the surgical procedure. The height of the convex component 125 is higher than the height of the clamping teeth 120, thus making it easily identifiable under medical imaging. The depth of the groove 119 can be less than the sum of the thickness of the convex member 125 and the leaflet. Therefore, when there are leaflets piled up between the convex member 125 and the groove 119, the convex member 125 cannot be completely contained in the groove 119. That is, the first clamping member 11 and the second clamping member 12 cannot be completely closed when they are closed.

[0082] The convex component 125 is preferably a trihedron or a tetrahedron to provide better recognition under medical imaging. Of course, it can also be cylindrical or the like. The positions of the convex component 125 and the groove 119 can also be interchanged, that is, the convex component 125 is provided in the first clamping member 11, and the groove 119 is provided in the second clamping member 12.

[0083] Please refer to it again. Figure 7The first clamping member 11 is also provided with an angiography channel 140, which is connected to the non-clamping area 116 and is used to introduce contrast agent. When the first clamping member 11 and the second clamping member 12 do not clamp the leaflet, the contrast agent flowing out of the angiography channel 140 can be observed under medical imaging, such as digital subtraction angiography (DSA) X-rays. When the first clamping member 11 and the second clamping member 12 clamp the leaflet, the angiography channel 140 will be covered or blocked by the leaflet, so that a leaflet falls between the first clamping member 11 and the second clamping member 12. Additionally, when contrast agent is observed flowing out of the contrast channel 140, the valve leaflets are not clamped, and the contrast channel 140 can be used to aspirate the blood expelled during surgery; that is, it serves as a blood aspiration channel at this time. When the contrast channel 140 is covered or blocked, preventing the injection of contrast agent, it indicates that the valve leaflets are clamped, and it is recommended not to aspirate the blood expelled during surgery in this case. In this embodiment, there are two contrast channels 140, located below the non-clamping area 116.

[0084] In this embodiment of the invention, after the capture component 10 of the artificial chordal implantation device 100 captures the leaflet, the artificial chordal implantation component 20 implants an artificial chordal into the captured leaflet. The artificial chordal implantation component 20 punctures the leaflet with a puncture needle and then pushes the artificial chordal from inside the puncture needle to the outside to reach the other side of the leaflet.

[0085] Please refer to the following: Figure 8 and Figure 13 The first clamping member 11 is provided with a guide groove 117, which communicates with the non-clamping area 116 of the first clamping member 11 and has an opening in the non-clamping area 116. In this embodiment, the guide groove 117 is located above the non-clamping area 116. The non-clamping area 126 of the second clamping member 12 has a limiting groove 127 extending through the second clamping member 12 and open at one end, in the proximal direction, i.e., the end direction of the second clamping member 12. When the second clamping member 12 and the first clamping member 11 are closed, the limiting groove 127 is lower than the guide groove 117 and aligned with the guide groove 117 (see...). Figure 13 Furthermore, the width or diameter D2 of the limiting groove 127 is greater than the diameter D1 of the puncture needle, so that the puncture needle can pass through the limiting groove 127. The limiting groove 127 has a certain capacity to accommodate the leaflet, making it less likely for the puncture needle to slip out when puncturing the leaflet. The puncture needle has a certain needle tip, and the needle tip is optimally located at the midpoint of the limiting groove 127 at the puncture point of the leaflet, or two-thirds of the area of ​​the puncture needle is accommodated by the limiting groove 127 to allow the needle tip to puncture the leaflet, ensuring that the puncture needle will not slip out and that the puncture is stable.

[0086] like Figure 14 and Figure 15 As shown, the non-clamping area 126 of the second clamping member 12 has an inclination angle A relative to the clamping area 124. The non-clamping area 116 of the first clamping member 11 is parallel to the non-clamping area 126 of the second clamping member 12, therefore the non-clamping area 116 of the first clamping member 11 also has an inclination angle A relative to the clamping area 114. The guide groove 117 includes an inclined segment 117a adjacent to the non-clamping area 116 of the first clamping member 11. The inclined segment 117a is inclined upward relative to the inclined starting point of the guide groove 117 within the first clamping member 11, forming an inclination angle B relative to the inclined starting point. This inclination angle B appropriately raises the exit angle of the puncture needle. The angle C between the needle tip and the leaflet when the puncture needle punctures the leaflet satisfies C = A + B. Preferably, the inclination angle A of the non-clamping area 116 is between 45 and 70 degrees, the inclination angle B of the guide groove 117 is between 0 and 20 degrees, and the angle C of the puncture needle piercing the valve leaflet is between 45 and 90 degrees. In this embodiment, the inclination angle A of the non-clamping area 116 is 70 degrees or close to 70 degrees, the inclination angle B of the guide groove 117 is 20 degrees or close to 20 degrees, and the angle C of the puncture needle piercing the valve leaflet is 90 degrees or close to 90 degrees. That is, the puncture needle is in a state of basically perpendicular puncture of the valve leaflet. This helps to prevent the needle from slipping during puncture and prevents the needle from scratching the valve leaflet, causing secondary damage to the valve leaflet.

[0087] Please see Figure 16 The first clamping member 11 has a connector 150 at its proximal end, away from the second clamping member 12. The guide groove 117, the transmission channel 115, and the angiography channel 140 extend from the connector 150 toward the non-clamping area 116. The connector 150 is used to connect the delivery catheter 16 (see...). Figure 13 ).

[0088] Specifically, the proximal portion of the first clamping member 11 has a cylindrical end 150a. A non-clamping area 116 of the first clamping member 11 is formed on the side of the cylindrical end 150a facing the second clamping member 12, and the connector 150 is formed on the other side of the cylindrical end 150a. The top of the cylindrical end 150a is the highest point of the first clamping member 11. When the second clamping member 12 is closed with the first clamping member 11, the top of the cylindrical end 150a is higher than the top of the second clamping member 12. This facilitates transport, preventing the movable second clamping member 12 from being collided with the transport sheath. The connector 150 is recessed downwards relative to the cylindrical end 150a to accommodate the transport conduit 16. After the transport conduit 16 is fitted with the connector 150, the transport conduit 16 is substantially flush with the surface of the cylindrical end 150a. The guide groove 117, transmission channel 115, and contrast channel 140 extend from the connector 150 through the cylindrical end 150a toward one side of the non-clamping area 116. The transmission channel 115 and the two contrast channels 140 are through holes in the connector 150, and the guide groove 117 is an open form with an incomplete arc at the location of the connector 150. Due to the upward curvature of the guide groove 117 in the inclined section 117a of the first clamping member 11, there may be more resistance when the puncture needle travels. Therefore, the open form of the connector 150 helps to reduce the resistance when the puncture needle travels.

[0089] Please see Figure 17 The delivery conduit 16 is made of a polymer material and is slender and flexible. One end 165 can be heat-fused to cover the inwardly recessed portion of the connector 150. The delivery conduit 16 has multiple spaced-apart cavities that correspond to and connect to the guide groove 117, the transmission channel 115, and the two contrast channels 140 of the first clamping member 11. The transmission cavity 161 of the delivery conduit 16 corresponding to the transmission channel 115 is used to accommodate the transmission shaft 132 extending from the first clamping member 11. This transmission shaft 132 can be a metal rod that passes through the delivery conduit 16 and connects to the operating handle 18 (see...). Figure 18 The corresponding drive device of the delivery catheter 16. The needle insertion cavity 162 of the corresponding guide groove 117 of the delivery catheter 16 is used to accommodate the puncture needle, which is also connected to the operating handle. The contrast cavity 163 of the corresponding contrast channel 140 of the delivery catheter 16 is used to introduce contrast agent or as a channel for blood aspiration during surgery.

[0090] Please see Figure 18The proximal end of the delivery conduit 16, away from the leaflet capture assembly 10, is connected to an operating handle 18. The operating handle 18 has a button 181 connected to a drive shaft 132. A groove for sliding the button 181 can be formed in the housing 180 of the operating handle 18. Pressing and pushing the button 181 can drive the drive shaft 132 to move axially, thereby moving the transmission connector 134. This allows the second clamping member 12 of the leaflet capture assembly 10 to open or close relative to the first clamping member 11. The operating handle 18 also has a gas-liquid valve 182, which can serve as a contrast agent inlet, a blood aspiration channel, and an air vent during surgery. The operating end of the artificial chordae tendineae implantation assembly 20 can be movably mounted on the end of the housing 180 of the operating handle 18.

[0091] Please refer to the following: Figures 19 to 21 The artificial chordae tendineae implantation assembly 20 includes a puncture needle assembly 21 and an artificial chordae tendineae pushing assembly 22. The puncture needle assembly 21 includes a puncture needle pushing handle 211, a guide assembly 212, and a puncture needle 213. The puncture needle pushing handle 211 is movably housed in the housing 180 of the operating handle 18. The puncture needle 213 is fixedly connected to the puncture needle pushing handle 211. The guide assembly 212 includes a guide sleeve 212a and a guide shaft 212b. The guide sleeve 212a is fixedly connected to the puncture needle pushing handle 211. The guide shaft 212b is fixed in the housing 180 of the operating handle 18, and one end is housed in the guide sleeve 212a. Its inner diameter is slightly larger than the outer diameter of the puncture needle 213, but it can support the puncture needle 213, thus guiding the puncture needle 213. When the puncture needle push handle 211 is pushed, the guide sleeve 212a moves axially along the outer diameter of the guide shaft 212b, and the puncture needle 213 is pushed along the inner diameter of the guide shaft 212b through the delivery conduit 16 to reach the guide groove 117 of the leaflet capture assembly 10.

[0092] The artificial tendon chord delivery assembly 22 includes a delivery handle 221, a delivery shaft 222, and a delivery conduit 223. The delivery handle 221 may be a ring. One end of the delivery shaft 222 is fixedly connected to the delivery handle 221, and the other end extends into the puncture needle delivery handle 211 and is fixedly connected to the delivery conduit 223. The delivery conduit 223 is movably housed in the puncture needle 213. The artificial tendon chord 225 may be loaded into the delivery conduit 223, and the artificial tendon chord 225 does not need to be fixed in the delivery conduit 223. The end of the artificial tendon chord 225 extends out of the delivery conduit 223 and is housed in the puncture needle 213. The artificial tendon chord 225 may be threaded onto a gasket 225a, which is placed at the end of the delivery conduit 223. The end of the artificial tendon chord 225 may be knotted. The gasket 225a may be a metal tube. The artificial tendon chord 225, together with the gasket 225a, is pushed out of the puncture needle 213 by the delivery conduit 223.

[0093] Please see Figures 22 to 25 The artificial chordal implantation device 500 provided in the second embodiment of the present invention differs from the artificial chordal implantation device 100 of the first embodiment in that two convex components 125a are provided in the first clamping member 11a, and the two convex components 125a are respectively located on both sides of the transmission channel 115. Two grooves 119a are provided in the second clamping member 12a, and the two grooves 119a are corresponding to the two convex components 125a. The two convex components 125a are cylindrical, and the two grooves 119a are circular holes and are through holes. The size of each groove 119a in the second embodiment is smaller than that of the groove 119a in the first embodiment, so that the leaflets are less likely to accumulate in the groove 119a. If a leaflet covers the groove 119a, the convex component 125a cannot cooperate with the groove 119a and can be observed by medical imaging. At this time, the position of the leaflet falling into the leaflet capture component can be adjusted by the transmission component 13.

[0094] Please refer to the following: Figures 26 to 29 The delivery catheter 16 of the artificial chordal implantation device 100 can be loaded in a bending sheath, which may include a first bending sheath 200 and a second bending sheath 200. The first and second bending sheaths 200 guide and bend within the heart tissue during delivery of the artificial chordal implantation device. The first bending sheath 200, the second bending sheath 200, and the artificial chordal implantation device 100 can be operated independently externally. Under medical imaging, the leaflet capture assembly 10 is delivered above the heart leaflet 400 to be repaired. Then, the second clamp of the leaflet capture assembly 10 opens relative to the first clamp. At this time, the operating handle of the artificial chordal implantation device 100 can be finely adjusted so that the second clamp is at a substantially perpendicular angle to the leaflet to align with and retract the leaflet. The leaflet capture assembly 10 is then closed to clamp the leaflet. The artificial chordal implantation assembly 20 can then be operated to insert the puncture needle 213 into the leaflet (see...). Figure 31 ), and push the artificial tendineae to the other side of the leaflet.

[0095] Please refer to the following: Figure 6 , Figure 9 , Figure 30 and Figure 31In this embodiment of the invention, when the leaflet capturing assembly 10 of the artificial chordae tendineae implantation device 100 enters the heart valve to be repaired, such as the mitral valve, the second clamping member 12 opens relative to the first clamping member 11 to align with the leaflet of the mitral valve. At this time, the leaflet to be repaired, such as the anterior or posterior leaflet, can fall between the first clamping member 11 and the second clamping member 12. Due to the curved design of the transmission connector 134 of the transmission assembly 13, during the closing process of the second clamping member 12 relative to the first clamping member 11, the curved part 134a will push the leaflet from the arc surface 134d to the first flat surface 134e, so that the leaflet is basically clamped between the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12, preventing excessive leaflet accumulation between the connecting part 112 of the first clamping member 11 and the connecting part 122 of the second clamping member 12. When the protruding part 125 on the second clamp 12 cannot close with the groove 119 on the first clamp 11, it also serves as a prompt, indicating that the leaflet capturing assembly 10 can be finely adjusted in angle, and the second clamp 12 can reopen and close relative to the first clamp 11 to receive the leaflet.

[0096] As mentioned above, in the artificial chordae tendineae implantation device 100 of the present invention, the non-clamping areas 116, 126 of the first clamping member 11 and the second clamping member 12 of the leaflet capture assembly 10 exactly form a puncture area. The inclined design of the non-clamping areas 116, 126, the angle design of the guide groove 117, and the design of the limiting groove 127 (see...) Figure 6-8 This ensures that the puncture needle is positioned approximately perpendicular to the valve leaflet during insertion, making the puncture easier and more accurate.

[0097] In this embodiment of the invention, the artificial chordal implantation device 100, after the artificial chordal implantation component 20 pushes the artificial chordal 225 to the other side of the valve leaflet, can use another instrument to fix the artificial chordal 225 to the heart tissue, directly replacing the function of the native cardiac chordal. The pad 225a of the artificial chordal 225 helps to fix the artificial chordal 225 to the papillary muscle. The artificial chordal 225 can be one or two sutures, and its material can be PTFE, e-PTFE, PET, UHMWPE, etc.

[0098] After the artificial chord tendon implantation device 100 of this embodiment completes the artificial chord tendon implantation, the artificial chord tendon 225 remains in the heart tissue. At this time, the puncture needle is withdrawn, and then the leaflet capture assembly 10 is withdrawn, so that the artificial chord tendon implantation device 100 is completely separated from the heart tissue and withdrawn.

[0099] It is understood that the above illustrations are only for example, illustrating the puncture direction of the valve leaflet from the atrial side to the ventricular side during artificial chordae tendineae implantation. The artificial chordae tendineae implantation device of this application can also be used to puncture the valve leaflet from the ventricular side to the atrial side, for example, using the delivery path via the right ventricle-interventricular septum-left ventricle-mitral valve, or the delivery path via the apex-left ventricle-mitral valve. Of course, the artificial chordae tendineae implantation device of this application can also be used for artificial chordae tendineae implantation of the tricuspid valve. Except for the difference in the interventional procedure path, the structure of the tricuspid valve artificial chordae tendineae implantation device is the same as that of the mitral valve artificial chordae tendineae implantation device, and will not be described again here.

[0100] The above description is merely a preferred embodiment of this application and does not constitute any limitation on this application. Although this application has disclosed preferred embodiments as above, it is not intended to limit this application. Any person skilled in the art can make many possible variations and modifications to the technical solutions of this application using the methods and techniques disclosed above, or modify them into equivalent embodiments with equivalent changes, without departing from the scope of the technical solutions of this application. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of this application without departing from the content of the technical solutions of this application shall still fall within the protection scope of the technical solutions of this application.

Claims

1. An artificial chordae tendineae implantation device, characterized in that, It includes: A leaflet capturing assembly includes a first clamping member, a second clamping member, and a transmission assembly. Driven by the transmission assembly, the second clamping member can open relative to the first clamping member to form an angle, or close to capture and clamp the leaflet of the valve between the first and second clamping members. The opposing surfaces of the first and second clamping members are each provided with a clamping area and a non-clamping area. The first and second clamping members are each provided with a connecting portion, located on the side of the clamping area away from the non-clamping area. One of the first and second clamping members has a protruding convex component. Another of the two clamping members is provided with a groove. The convex component is disposed between the clamping area and the connecting portion of one of the first clamping member and the second clamping member. The groove is disposed between the clamping area and the connecting portion of the other of the first clamping member and the second clamping member. When the first clamping member and the second clamping member are relatively closed and the leaflets do not fall between the convex component and the groove, the convex component is received in the groove. When the first clamping member and the second clamping member are relatively closed and the leaflets fall between the convex component and the groove, the convex component fails to be received in the groove, so that the first clamping member and the second clamping member cannot be completely closed. as well as An artificial chordae tendineae implantation assembly includes a puncture needle and a pushable artificial chordae tendineae housed within the puncture needle. After the leaflet capture assembly captures and clamps the leaflet, the puncture needle punctures the leaflet, and the artificial chordae tendineae ...

2. The artificial chordae tendineae implantation device as described in claim 1, characterized in that, At least one of the clamping areas is provided with clamping teeth to clamp the leaflet between the two clamping areas. When the first clamping member and the second clamping member are closed relative to each other, there is a gap between the non-clamping areas of the first clamping member and the second clamping member to accommodate a portion of the leaflet that is not clamped. The gap is between 0.5 and 2 mm.

3. The artificial tendon chord implantation device as described in claim 2, characterized in that, The connecting portion of the second clamping member is hinged to the connecting portion of the first clamping member, and one end of the transmission assembly is connected to the connecting portion of the second clamping member to drive the second clamping member to open and close relative to the first clamping member.

4. The artificial chordae tendineae implantation device as described in claim 3, characterized in that, The first clamping member is provided with a transmission channel, which communicates with the clamping area of ​​the first clamping member and extends to the connecting part. The transmission assembly includes a transmission shaft and a transmission connector. The transmission shaft is movably housed in the transmission channel. One end of the transmission connector is pivotally connected to the second clamping member via a first pivot shaft. The other end of the transmission connector is movably housed in the transmission channel and is pivotally connected to one end of the transmission shaft via a second pivot shaft.

5. The artificial chordae tendineae implantation device as described in claim 4, characterized in that, The connecting portion of the second clamping member has two ribs arranged at relative intervals. The ends of the two ribs away from the clamping area are hinged to both sides of the connecting portion of the first clamping member via a pivot shaft. The ends of the two ribs near the clamping area are pivotally connected to the transmission connecting member via the first pivot shaft.

6. The artificial chordae tendineae implantation device as described in claim 4, characterized in that, The clamping areas of the first clamping member and the second clamping member are provided with a plurality of mutually adapted clamping teeth to clamp the leaflets. The transmission channel has an opening in the clamping area of ​​the first clamping member, and the opening interrupts part of the clamping teeth of the first clamping member.

7. The artificial chordae tendineae implantation device as described in claim 6, characterized in that, The height of the convex component is higher than the height of the clamping teeth.

8. The artificial chordae tendineae implantation device as described in claim 7, characterized in that, The convex component is disposed on the second clamping member, the groove is disposed on the first clamping member, and the transmission channel interrupts the groove.

9. The artificial chordae tendineae implantation device as described in claim 7, characterized in that, The convex component is disposed on the first clamping member, and there are two convex components, which are respectively located on both sides of the transmission channel. The groove is disposed on the second clamping member, and there are two grooves, which are disposed corresponding to the two convex components.

10. The artificial chordae tendineae implantation device as described in claim 4, characterized in that, A limiting boss is provided at the connection between the transmission channel and the connecting part. The limiting boss is used to limit the transmission connector to restrict the maximum opening angle of the second clamping member relative to the first clamping member. The transmission channel includes a curved section. The limiting boss is located at the end position of the curved section at the connecting part. The transmission connector includes a curved part and a straight part connecting the curved part. The curved part has a rounded corner near the bottom surface of the curved section. The surface of the curved part away from the curved section has an arc surface. The surface of the straight part connecting the arc surface is a straight surface. At least a portion of the arc surface is located in the second clamping member. At least a portion of the straight part is located in the first clamping member.

11. The artificial chordae tendineae implantation device as described in claim 2, characterized in that, The non-clamping areas of the first clamping member and the second clamping member are respectively inclined relative to the clamping area, and the non-clamping areas of the first clamping member and the second clamping member are parallel to each other. The first clamping member is provided with a guide groove, which is connected to the non-clamping area of ​​the first clamping member. The non-clamping area of ​​the second clamping member is provided with a limiting groove that penetrates the second clamping member and is open at one end. The limiting groove is aligned with and lower than the guide groove. The puncture needle passes through the guide groove and punctures the leaflet in the limiting groove.

12. The artificial chordae tendineae implantation device as described in claim 11, characterized in that, The non-clamping areas of the first clamping member and the second clamping member have an inclination angle A relative to the corresponding clamping areas. The guide groove includes an inclination segment adjacent to the non-clamping area of ​​the first clamping member. The inclination segment has an inclination angle B relative to the inclination starting point of the guide groove in the first clamping member. The angle C of the puncture needle puncturing the valve leaf satisfies C=A+B. The angle C of the puncture needle puncturing the valve leaf is between 45 and 90 degrees.

13. The artificial chordae tendineae implantation device as described in claim 1, characterized in that, The artificial tendon is a suture, which is knotted and threaded onto a pad. The suture, together with the pad, is pushed to the other side of the leaflet by the puncture needle.

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