Leaflet enhancement device

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a valve leaflet enhancing device which comprises a catheter component, a driving mechanism, a clamping assembly, an artificial valve leaflet and a puncture assembly, the driving mechanism comprises a handle assembly and a driving assembly, the clamping assembly comprises a first clamping arm and a second clamping arm, and the first clamping arm is provided with a first clamping face; the second clamping arm is provided with a second clamping face matched with the first clamping face, the artificial valve leaflet is detachably connected to the second clamping arm, and the puncture assembly comprises a first puncture structure and a second puncture structure. When the second clamping arm is closed, the first puncture structure is in puncture connection with the middle area of the native valve leaflet and the middle area of the artificial valve leaflet, and then when the second clamping arm, the artificial valve leaflet and the native valve leaflet are opened together, the second puncture structure is in puncture connection with the side edge area, located on at least one side of the two sides of the second clamping arm, of the native valve leaflet and the artificial valve leaflet. Therefore, the problem that blood regurgitation is caused due to the fact that the side edge areas of the original valve leaflet and the artificial valve leaflet cannot be stably attached after an existing heart valve leaflet repairing operation is solved.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and in particular relates to a leaflet enhancement device. Background Technology

[0002] Patients with mitral regurgitation undergo heart valve repair surgery, in which an artificial valve leaflet is implanted onto the original valve leaflet to strengthen the original leaflet, aiming to achieve a good closure between the mitral valves.

[0003] However, current cardiac valve repair techniques only anchor the central region of the original and artificial leaflets when implanting an artificial leaflet. This results in unstable adhesion between the lateral regions of the original and artificial leaflets. When these lateral regions are impacted by blood flow, they may be forced apart, potentially leading to blood backflow and unsatisfactory surgical outcomes. Summary of the Invention

[0004] The purpose of this application is to provide a leaflet enhancement device, which aims to solve the problem that after current heart valve repair surgery, there is a possibility of blood backflow due to the inability of the original leaflet and the artificial leaflet to fit stably in the lateral area.

[0005] To achieve the above objectives, the technical solution adopted in this application is: a leaflet enhancement device, comprising a catheter component, a driving mechanism, a clamping assembly, an artificial leaflet, and a puncture assembly. The driving mechanism includes a handle assembly and a driving assembly. The handle assembly is located at the proximal end of the catheter component, and the driving assembly is connected to the handle assembly and passes through the catheter component. The clamping assembly includes a first clamping arm and a second clamping arm. The first clamping arm is located at the distal end of the catheter component, and the proximal end of the second clamping arm is rotatably connected to the proximal end of the first clamping arm or the distal end of the catheter component. The driving assembly is drivenly connected to the second clamping arm to drive the second clamping arm to open or close relative to the first clamping arm. The first clamping arm has a first clamping surface, and the distal end of the second clamping arm has... The device has a second clamping surface that can adapt to and contact the first clamping surface when the second clamping arm is closed, for clamping the native leaflet. The artificial leaflet can be detachably connected to the second clamping arm and abutted against the second clamping surface. The puncture assembly includes a first puncture structure and a second puncture structure. The first puncture structure is disposed between the catheter member and the first clamping arm, and the second puncture structure is disposed through the catheter member. When the second clamping arm is closed, the first puncture structure punctures and connects the native leaflet and the artificial leaflet in the middle region. Then, when the second clamping arm, the artificial leaflet, and the native leaflet are all open, the second puncture structure punctures and connects the native leaflet and the artificial leaflet in the side region of at least one of the two sides of the second clamping arm.

[0006] In some embodiments, there are two second puncture structures arranged side by side along a direction perpendicular to the catheter member, with each second puncture structure puncturing the side regions on both sides of the second clamp arm that connect the native leaflet and the artificial leaflet.

[0007] In some embodiments, the second puncture structure includes a puncture needle, a push rod, and an anchoring member. The puncture needle has a channel passing through its distal and proximal ends. The push rod passes through the channel, and the anchoring member is slidably disposed in the channel. The anchoring member and the distal end of the push rod are detachably connected. When the puncture needle punctures the native leaflet and the artificial leaflet, the push rod pushes the anchoring member to slide out of the channel and connect the lateral regions of the native leaflet and the artificial leaflet.

[0008] In some embodiments, the anchoring member includes a first anchoring block, a second anchoring block, and an elastic connecting line. The first anchoring block or the second anchoring block is detachably connected to the distal end of the push rod. The two ends of the elastic connecting line are respectively fixedly connected to the middle of the first anchoring block and the middle of the second anchoring block. Both the first anchoring block and the second anchoring block can be slidably disposed in the channel. The length direction of the first anchoring block and the length direction of the second anchoring block are consistent with the extension direction of the channel. Furthermore, the first anchoring block and the second anchoring block clamp the original leaflet and the artificial leaflet under the elastic tension of the elastic connecting line.

[0009] In some embodiments, the distal end of the push rod is provided with a first buckle, and one end of the first anchor block or one end of the second anchor block is provided with a second buckle adapted to the first buckle, and the first buckle and the second buckle are detachably fastened together.

[0010] In some embodiments, a first mounting hole is provided in the middle of the first anchor block, the axis of the first mounting hole being perpendicular to the length direction of the first anchor block; a second mounting hole is provided in the middle of the second anchor block, the axis of the second mounting hole being perpendicular to the length direction of the second anchor block; and the orientation of the opening of either the first mounting hole or the second mounting hole is opposite to the orientation of the opening of the second buckle.

[0011] In some embodiments, the first anchor block is further provided with a third mounting hole, the extension direction of the third mounting hole is consistent with the length direction of the first anchor block, the third mounting hole is connected to the first mounting hole, and one end of the elastic connecting wire passes through the first mounting hole and the third mounting hole in sequence; and / or, the second anchor block is further provided with a fourth mounting hole, the extension direction of the fourth mounting hole is consistent with the length direction of the second anchor block, the fourth mounting hole is connected to the second mounting hole, and the other end of the elastic connecting wire passes through the second mounting hole and the fourth mounting hole in sequence.

[0012] In some embodiments, the distal end of the catheter member is provided with a guide ramp, which is in contact with the distal outlet of the installation channel for passing through the second puncture structure. The guide ramp is inclined from the proximal end to the distal end of the catheter member in a direction away from the central axis of the catheter member.

[0013] In some embodiments, the leaflet enhancement device further includes an implantation anchor and a release rod. The implantation anchor is fixedly disposed with the artificial leaflet. The side of the implantation anchor opposite to the artificial leaflet is provided with a fixing hole. The second clamping arm is provided with an insertion hole corresponding to the fixing hole. The release rod passes through the catheter component, and the distal end of the release rod passes through the fixing hole and is inserted into the insertion hole. The first puncture structure includes a fastening member. The first clamping arm is provided with a guide groove that extends to the first clamping surface. The fastening member is slidably installed in the guide groove. The driving component is driven to connect with the fastening member. The driving component drives the fastening member to slide out of the guide groove to puncture the original leaflet and the artificial leaflet and connect to the implantation anchor.

[0014] In some embodiments, the clamping assembly further includes an auxiliary clamping arm, which is rotatably mounted on the first clamping arm. The auxiliary clamping arm has an auxiliary clamping portion. A drive assembly is driven to the auxiliary clamping arm to drive the auxiliary clamping arm to open or close relative to the first clamping arm. When the second clamping arm is open, the drive assembly drives the auxiliary clamping arm to move toward the second clamping arm so that the auxiliary clamping portion can abut against the second clamping surface. Furthermore, the auxiliary clamping arm has a clearance channel. When the auxiliary clamping arm is closed, the clearance channel is directly opposite the guide groove.

[0015] This application has at least the following beneficial effects: The operator uses the leaflet enhancement device provided in the embodiments of this application to perform cardiac leaflet repair surgery. During the surgery, the original leaflet is stably clamped by the clamping assembly. Then, the central region of the original leaflet and the artificial leaflet is punctured and connected through the first puncture structure. Next, the lateral region of the artificial leaflet and the original leaflet located on at least one side of the second clamping arm is punctured and connected through the second puncture structure until both lateral regions of the artificial leaflet and the original leaflet are punctured and connected. In this way, in addition to puncturing and connecting the central region of the artificial leaflet and the original leaflet, the lateral regions of both sides of the artificial leaflet and the original leaflet are also punctured and connected, thereby maintaining a stable fit between the lateral regions of the artificial leaflet and the original leaflet. This allows the enhanced leaflet to achieve a good closure effect, reducing the possibility of blood backflow from the lateral regions of the original leaflet and the artificial leaflet when blood flow impacts the leaflet, and improving the surgical outcome of cardiac leaflet repair surgery. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the assembly structure of the leaflet enhancement device according to an embodiment of this application; Figure 2 This is a partial cross-sectional schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application; Figure 3 A schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application. Figure 1 The second clamping arm is in the open position. Figure 4 A schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application. Figure 2 In this case, the second clamping arm is in the open state, and the original leaflet enters between the first clamping arm and the second clamping arm; Figure 5 A schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application. Figure 3 The second clamping arm and the auxiliary clamping arm hold the original leaflet; Figure 6 A schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application. Figure 4 The first clamping arm and the second clamping arm hold the original leaflet; Figure 7 A schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application. Figure 5 In this case, the second clamping arm, the artificial leaflet, and the original leaflet are all in the open state, and the second puncture structure is not punctured. Figure 8 A schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application. Figure 6 In this case, the second clamping arm, the artificial leaflet, and the original leaflet are all in the open state, and the second puncture structure is not punctured. Figure 9 A schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application. Figure 7 In this case, the second clamping arm, the artificial leaflet, and the original leaflet are all in the open state, and the second puncture structure performs the puncture. Figure 10 A schematic diagram of the distal end of the leaflet enhancement device according to an embodiment of this application. Figure 8 In this case, the second clamping arm, the artificial leaflet, and the original leaflet are all in the open state, and the second puncture structure performs the puncture. Figure 11 A schematic diagram of the structure in which the original leaflet and the artificial leaflet are connected by implanted anchors, fasteners and anchoring components; Figure 12 A schematic diagram of the structure in which the native leaflet and the artificial leaflet are connected by an implanted anchor and fastener; Figure 13 A schematic diagram of the structure connecting the native leaflet and the artificial leaflet by the anchoring component; Figure 14 This is a schematic diagram of the assembly structure of the third drive rod and an auxiliary clamping arm of the leaflet enhancement device according to an embodiment of this application; Figure 15 This is a schematic diagram of another auxiliary clamping arm of the leaflet enhancement device according to an embodiment of this application; Figure 16 This is a cross-sectional schematic diagram of the second puncture structure of the leaflet enhancement device according to an embodiment of this application penetrating the catheter component; Figure 17 This is an exploded view of the second puncture structure of the leaflet enhancement device according to an embodiment of this application; Figure 18 for Figure 17 Enlarged view of point A in the middle; Figure 19 for Figure 17 Enlarged diagram of point B in the middle.

[0018] The figures in the diagram are labeled as follows: 10. Conduit components; 11. Guide ramp; 20. Drive mechanism; 21. Handle assembly; 221. First drive rod; 222. Third drive rod; 30. First clamping arm; 31. First clamping surface; 32. Receiving groove; 33. Second anti-slip structure; 34. Guide groove; 35. Head end piece; 40. Second clamping arm; 41. Second clamping surface; 42. Insertion hole; 50. Auxiliary clamping arm; 51. Auxiliary clamping part; 52. Clearance passage; 53. Rotating column; 54. First anti-slip structure; 61. Anchor insertion; 611. Fixing hole; 612. Anchor hole; 62. Release rod; 71. Original leaflet; 72. Artificial leaflet; 73. Central region; 74. Lateral region; 81. First pin; 82. Second pin; 90. Puncture assembly; 91. First puncture structure; 911. Fastener; 9111. Fastener plate; 9112. Puncture nail; 9113. Nail head; 9114. Nail rod; 912. Second drive rod; 913. Drive block; 9131. Drive ramp; 92. Second puncture structure; 921. Puncture needle; 9211. Channel; 922. Push rod; 9221. First snap; 923. Anchoring component; 9231. First anchoring block; 9232. Second anchoring block; 9233. Elastic connecting wire; 9234. Second snap; 9235. First mounting hole; 9236. Second mounting hole; 9237. Third mounting hole; 9238. Fourth mounting hole. Detailed Implementation

[0019] The embodiments of this application are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this application, and should not be construed as limiting this application.

[0020] In the description of this application, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0021] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0022] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0023] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the medical device field. "Distal" refers to the end furthest from the operator during surgery, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0024] Embodiments of this application provide a leaflet enhancement device. For example... Figures 1 to 10 As shown, the leaflet enhancement device includes a catheter component 10, a drive mechanism 20, a clamping assembly, an artificial leaflet 72, and a puncture assembly 90. The drive mechanism 20 includes a handle assembly 21 and a drive assembly. The handle assembly 21 is located at the proximal end of the catheter component 10, and the drive assembly is connected to the handle assembly 21 and passes through the catheter component 10. The clamping assembly includes a first clamping arm 30 and a second clamping arm 40. The first clamping arm 30 is located at the distal end of the catheter component 10, and the proximal end of the second clamping arm 40 is rotatably connected to either the proximal end of the first clamping arm 30 or the distal end of the catheter component 10. The drive assembly is driven to open or close the second clamping arm 40 relative to the first clamping arm 30. The first clamping arm 30 has a first clamping surface 31, and the distal end of the second clamping arm 40 has a second clamping surface 41. When the second clamping arm 40 is closed, it can adapt to contact with the first clamping surface 31 to clamp the native leaflet 71. The artificial leaflet 72 can be detachably connected to the second clamping arm 40 and abut against the second clamping surface 41. The puncture assembly 90 includes a first puncture structure 91 and a second puncture structure 92. The first puncture structure 91 is disposed between the catheter member 10 and the first clamping arm 30. The second puncture structure 92 passes through the catheter member 10. When the second clamping arm 40 is closed, the first puncture structure 91 punctures and connects the native leaflet 71 and the artificial leaflet 72 in the middle region 73. Then, when the second clamping arm 40, the artificial leaflet 72 and the native leaflet 71 are open together, the second puncture structure 92 punctures and connects the native leaflet 71 and the artificial leaflet 72 in the side region 74 of at least one of the two sides of the second clamping arm 40.

[0025] The operator uses the leaflet enhancement device provided in the embodiments of this application to perform cardiac leaflet repair surgery. The operator holds the handle assembly 21 and the catheter component 10 to push the distal end of the leaflet enhancement device to the original leaflet 71 to be enhanced in the heart. During the pushing process, the first clamping arm 30 and the second clamping arm 40 of the clamping assembly are in a relatively closed state, that is, the clamping assembly is initially in a closed state. Then, the operator drives the drive assembly by operating the handle assembly 21. The drive assembly first drives the second clamping arm 40 to open relative to the first clamping arm 30, so that the first clamping surface 31 and the second clamping surface 41 are separated from each other to form a space for accommodating the original leaflet 71 to be enhanced. Next, the operator holds the handle assembly 21 to adjust the relative position of the first clamping arm 30, the second clamping arm 40 and the original leaflet 71 to be enhanced, so that the original leaflet 71 to be enhanced is located between the first clamping surface 31 and the second clamping surface 41, and the original leaflet 71 to be enhanced is abutted against the side surface of the artificial leaflet 72 facing away from the second clamping surface 41. Then, the operator continues to operate the handle assembly 21 to drive the drive assembly to drive the second clamping arm 40 to close toward the first clamping arm 30. During this process, the second clamping arm 40 remains in contact with the original leaflet 71 to be reinforced, driving the original leaflet 71 closer to the first clamping surface 31 until the original leaflet 71 is moved onto the first clamping surface 31. Then, the first clamping surface 31 and the second clamping surface 41 stably clamp the original leaflet 71 to be reinforced. Next, the operator operates the puncture assembly 90 to perform a puncture connection operation between the original leaflet 71 and the artificial leaflet 72. The operator first operates the first puncture structure 91 to puncture and connect the middle region 73 of the original leaflet 71 and the artificial leaflet 72, thus connecting the original leaflet 71 to the artificial leaflet 72. Then, the operator operates the handle assembly 21 to drive the drive assembly, thereby opening the second clamping arm 40 relative to the first clamping arm 30. The second clamping arm 40, the artificial leaflet 72, and the native leaflet 71 are then opened relative to the first clamping arm 30 and remain open. Next, the operator operates the second puncture structure 92 to puncture and connect the artificial leaflet 72 and the native leaflet 71 at least one side region 74 on either side of the second clamping arm 40, until both side regions 74 of the artificial leaflet 72 and the native leaflet 71 are punctured and connected. Thus, based on the puncture and connection of the central region 73 of the artificial leaflet 72 and the original leaflet 71, the lateral regions 74 on both sides of the artificial leaflet 72 and the original leaflet 71 are also punctured and connected. This allows the lateral regions 74 on both sides of the artificial leaflet 72 and the original leaflet 71 to maintain a stable fit, thereby enabling the reinforced leaflet (i.e., the original leaflet 71 and the artificial leaflet 72) to achieve a good closure surgical effect. This reduces the possibility of blood backflow from the lateral regions 74 of the original leaflet 71 and the artificial leaflet 72 when blood flow impacts the leaflet, and improves the surgical outcome of the heart valve repair surgery.

[0026] In the leaflet enhancement device of this application, such as Figures 3 to 7 , Figure 9 and Figure 10 As shown, the drive assembly includes a first drive rod 221, which passes through the guide tube component 10. One end of the first drive rod 221 is connected to the handle assembly 21, as shown. Figures 2 to 7 , Figure 10 As shown, the proximal end of the second clamping arm 40 is rotatably connected to the proximal end of the first clamping arm 30 or the distal end of the conduit component 10 via a first pin 81. The other end of the first drive rod 221 is rotatably connected to the proximal end of the second clamping arm 40 via a second pin 82. The axis of the second pin 82 is parallel to and spaced apart from the axis of the first pin 81. When the operator operates the handle assembly 21 to drive the first drive rod 221, the first drive rod 221 drives the proximal end of the second clamping arm 40 to rotate around the axis of the first pin 81, thus opening or closing the second clamping arm 40 relative to the first clamping arm 30.

[0027] In the leaflet clamping device of this application, such as Figures 1 to 7 , Figure 10 As shown, a head end member 35 is mounted on the distal end of the first clamping arm 30. Furthermore, the distal end of the head end member 35 is configured with a smooth, rounded head. This allows the head end member 35 to first contact the human tissue during the process of pushing the clamping assembly, which is joined together, to the heart's original leaflet 71 to be reinforced. This opens up the human tissue, allowing the clamping assembly to be smoothly advanced. Moreover, the smooth, rounded head of the head end member 35 reduces the possibility of scratching or injuring the human tissue during advancement, protecting the patient's safety. In some feasible embodiments, the distal end of the first clamping arm 30 can be directly configured with a smooth, rounded head to replace the head end member 35.

[0028] In some embodiments of the leaflet enhancement device, there is only one second puncture structure 92. The side regions 74 on both sides of the artificial leaflet 72 and the original leaflet 71 need to be punctured and connected sequentially. That is, the side region 74 on one side is punctured and connected first, and then the side region 74 on the other side is punctured and connected.

[0029] In other embodiments of the leaflet enhancement device, such as Figure 1 , Figures 8 to 10As shown, there are two second puncture structures 92, arranged side by side along a direction perpendicular to the catheter component 10. During the puncture connection operation on the lateral regions 74 on both sides of the artificial leaflet 72 and the original leaflet 71, the two second puncture structures 92 respectively puncture and connect the lateral regions 74 of the original leaflet 71 and the artificial leaflet 72 located on both sides of the second clamping arm 40. That is, the two second puncture structures 92 simultaneously perform the puncture connection operation on the lateral regions 74 on both sides of the artificial leaflet 72 and the original leaflet 71. This helps reduce the number of repeated clamping operations, thereby reducing the operation time and, to some extent, reducing surgical risks.

[0030] In the leaflet enhancement device of the embodiments of this application, such as Figure 16 and Figure 17 As shown, the second puncture structure 92 includes a puncture needle 921, a push rod 922, and an anchoring member 923. The puncture needle 921 is provided with a channel 9211 that passes through its distal and proximal ends. The push rod 922 passes through the channel 9211. The anchoring member 923 is slidably disposed in the channel 9211. The anchoring member 923 is detachably connected to the distal end of the push rod 922. When the second clamping arm 40, the artificial leaflet 72, and the native leaflet 71 are opened relative to the first clamping arm 30 and remain open, the operator operates the puncture needle 921 to puncture the side region 74 of the native leaflet 71 and the artificial leaflet 72, so that the needle tip of the puncture needle 921 punctures through the artificial leaflet 72 and the native leaflet 71. Then, the operator operates the push rod 922, which pushes the anchoring member 923 to slowly slide out of the channel 9211. Furthermore, the operator operates the puncture needle 921 to retract, so that the needle tip of the puncture needle 921 exits from the artificial leaflet 72 and the native leaflet 71, thereby causing the anchoring member 923 to slide completely out of the channel 9211 and detach from the distal end of the push rod 922. The anchoring member 923 then connects the side region 74 of the native leaflet 71 and the artificial leaflet 72. Figure 11 As shown. Then, the operator continues to operate the puncture needle 921 and the push rod 922 to retract together into the catheter component 10 to facilitate the removal of the leaflet enhancement device from the body. It can be seen that the second puncture structure 92 performs an accurate, simple, and quick puncture connection operation on the lateral region 74 of the artificial leaflet 72 and the original leaflet 71, which helps to reduce the operation time.

[0031] like Figures 16 to 19 As shown, the anchoring member 923 includes a first anchoring block 9231, a second anchoring block 9232, and an elastic connecting line 9233. The first anchoring block 9231 or the second anchoring block 9232 is detachably connected to the distal end of the push rod 922. The two ends of the elastic connecting line 9233 are respectively fixedly connected to the middle portions of the first anchoring block 9231 and the second anchoring block 9232. As an example, the proximal end of the first anchoring block 9231 is detachably connected to the distal end of the push rod 922, such as... Figure 16 and Figure 17 As shown. When the anchoring member 923 is placed in the channel 9211 of the puncture needle 921, both the first anchoring block 9231 and the second anchoring block 9232 are slidably disposed in the channel 9211, and the length direction of the first anchoring block 9231 and the length direction of the second anchoring block 9232 are consistent with the extension direction of the channel 9211. At this time, the elastic connecting line 9233 is in a stretched state, that is, the elastic connecting line 9233 applies a tension to the first anchoring block 9231 and the second anchoring block 9232, so that the first anchoring block 9231 and the second anchoring block 9232 move closer to each other in the channel 9211. During the process of the push rod 922 pushing the anchoring component 923 out of the channel 9211, when the needle tip of the puncture needle 921 punctures the artificial leaflet 72 and the original leaflet 71, the operator operates the push rod 922 to push the second anchoring block 9232 out of the channel 9211. The second anchoring block 9232, which has slid out of the channel 9211, loses the restriction of the channel 9211 and flips under the tension of the elastic connecting line 9233. The second anchoring block 9232 flips until its length direction forms an angle with the elastic connecting line 9233, and the second anchoring block 9232 abuts against the original leaflet 71 under the elastic force of the elastic connecting line 9233. When the operator retracts the puncture needle 921 to remove its tip from the artificial leaflet 72 and the native leaflet 71, the operator again operates the push rod 922 to push the first anchor block 9231 out of the channel 9211. The first anchor block 9231, no longer restricted by the channel 9211, flips under the tension of the elastic connecting line 9233, and its proximal end separates from the distal end of the push rod 922. The first anchor block 9231 flips until its length direction forms an angle with the elastic connecting line 9233, and under the elastic force of the elastic connecting line 9233, it abuts against the artificial leaflet 72. Thus, the first anchor block 9231 and the second anchor block 9232, under the elastic tension of the elastic connecting line 9233, clamp the lateral region 74 of the native leaflet 71 and the artificial leaflet 72. In this way, by performing a simple puncture operation on the artificial leaflet 72 and the native leaflet 71 and using the anchoring component 923, the puncture connection operation of the lateral region 74 of the artificial leaflet 72 and the native leaflet 71 is completed. The operation process is accurate, simple, and quick. Furthermore, the first anchoring block 9231, the elastic connecting line 9233, and the second anchoring block 9232 can stably suture the lateral region 74 of the artificial leaflet 72 and the native leaflet 71. Figure 13 As shown, this reduces the likelihood of blood backflow from the lateral region 74 of the original leaflet 71 and the artificial leaflet 72 when blood flow impacts the leaflet, thus improving the surgical outcome.

[0032] The following descriptions will be based on the example of the proximal end of the first anchor block 9231 being detachably connected to the distal end of the push rod 922.

[0033] Furthermore, in the embodiments of this application, such as Figure 17 and Figure 18 As shown, the distal end of the push rod 922 is provided with a first buckle 9221, and one end of the first anchoring block 9231 is provided with a second buckle 9234 that matches the first buckle 9221 (of course, in other embodiments, one end of the second anchoring block 9232 may also be provided with a second buckle 9234 that matches the first buckle 9221, which will not be elaborated here). Figure 16 and Figure 17 As shown, the first latch 9221 and the second latch 9234 are detachably fastened together. Under the constraint of the channel 9211, the first anchor block 9231 allows the second latch 9234 to be stably fastened together with the first latch 9221. When the first anchor block 9231 is pushed out of the channel 9211 by the push rod 922, it loses the constraint of the channel 9211 and flips under the tension of the elastic connecting line 9233, allowing the second latch 9234 to easily and quickly disengage automatically from the first latch 9221. Furthermore, the flipped first anchor block 9231, under the elastic force of the elastic connecting line 9233, abuts against the artificial leaflet 72. Thus, the first anchor block 9231 and the second anchor block 9232, under the elastic tension of the elastic connecting line 9233, clamp the side regions 74 of the native leaflet 71 and the artificial leaflet 72.

[0034] And, as Figure 18 As shown, the first anchoring block 9231 has a first mounting hole 9235 in its center, and the axis of the first mounting hole 9235 is perpendicular to the length direction of the first anchoring block 9231. This allows the second anchoring block 9232, which is pushed and slid out of the channel 9211 by the push rod 922, to quickly and correctly flip under the tension of the elastic connecting line 9233 after losing the restriction of the channel 9211. Thus, the second anchoring block 9232 abuts against the original leaflet 71 under the elastic force of the elastic connecting line 9233. Figure 19 As shown, the second anchoring block 9232 has a second mounting hole 9236 in its center, and the axis of the second mounting hole 9236 is perpendicular to the length direction of the second anchoring block 9232. This allows the first anchoring block 9231, pushed and slid out of the channel 9211 by the push rod 922, to quickly and correctly flip under the tension of the elastic connecting line 9233 after losing the restriction of the channel 9211. Thus, the first anchoring block 9231 abuts against the artificial leaflet 72 under the elastic force of the elastic connecting line 9233. Furthermore, as... Figure 18As shown, the orientation of the opening of one of the first mounting holes 9235 and the second mounting hole 9236 is opposite to the orientation of the opening of the second buckle 9234, so that the proximal end of the first anchor block 9231 can be accurately and quickly separated from the distal end of the push rod 922 when flipped.

[0035] In some embodiments, such as Figure 18 As shown, the first anchoring block 9231 also has a third mounting hole 9237. The extension direction of the third mounting hole 9237 is consistent with the length direction of the first anchoring block 9231. The third mounting hole 9237 communicates with the first mounting hole 9235. One end of the elastic connecting wire 9233 is sequentially passed through the first mounting hole 9235 and the third mounting hole 9237. This allows one end of the elastic connecting wire 9233 to be connected to the first anchoring block 9231, improving connection efficiency. Furthermore, one end of the elastic connecting wire 9233 is recessed into the end of the third mounting hole 9237 away from the first mounting hole 9235, avoiding leaving any wire ends. And, as... Figure 19 As shown, the second anchoring block 9232 also has a fourth mounting hole 9238. The extension direction of the fourth mounting hole 9238 is consistent with the length direction of the second anchoring block 9232. The fourth mounting hole 9238 is connected to the second mounting hole 9236. The other end of the elastic connecting wire 9233 is sequentially passed through the second mounting hole 9236 and the fourth mounting hole 9238. This allows the other end of the elastic connecting wire 9233 to be connected to the second anchoring block 9232, improving connection efficiency. Furthermore, the other end of the elastic connecting wire 9233 is recessed into the end of the fourth mounting hole 9238 away from the second mounting hole 9236, avoiding leaving any wire ends.

[0036] In other embodiments, the third mounting hole 9237 may not be provided in the first anchoring block 9231. Instead, both ends of the first mounting hole 9235 are respectively extended to both sides of the first anchoring block 9231. One end of the elastic connecting wire 9233 passes through the first mounting hole 9235, and the other end of the elastic connecting wire 9233 is recessed in the end of the first mounting hole 9235 away from the second anchoring block 9232. Similarly, the fourth mounting hole 9238 may not be provided in the second anchoring block 9232. Instead, both ends of the second mounting hole 9236 are respectively extended to both sides of the second anchoring block 9232. The other end of the elastic connecting wire 9233 passes through the second mounting hole 9236, and the other end of the elastic connecting wire 9233 is recessed in the end of the second mounting hole 9236 away from the first anchoring block 9231.

[0037] In the embodiments of this application, such as Figure 7 , Figure 8 and Figure 16As shown, the distal end of the catheter component 10 is provided with a guide bevel 11. The guide bevel 11 is connected to the distal outlet of the mounting channel for inserting the puncture needle 921. The guide bevel 11 is inclined away from the central axis of the catheter component 10 from the proximal end to the distal end. When the operator operates the puncture needle 921 to puncture the lateral region 74 of the artificial leaflet 72 and the original leaflet 71, the needle tip of the puncture needle 921 will move along the guide bevel 11. That is, the guide bevel 11 guides the needle tip of the puncture needle 921 to puncture the lateral region 74 of the artificial leaflet 72 and the original leaflet 71, so that the puncture target of the needle tip of the puncture needle 921 is accurate, improving puncture efficiency and puncture effect.

[0038] like Figure 2 and Figure 12 As shown, the leaflet enhancement device provided in the embodiments of this application further includes an implantation anchor 61 and a release rod 62. The implantation anchor 61 is fixedly disposed with the artificial leaflet 72. The side of the implantation anchor 61 facing away from the artificial leaflet 72 is provided with a fixing hole 611. The second clamping arm 40 is provided with an insertion hole 42 corresponding to the fixing hole 611. The release rod 62 passes through the catheter member 10, and the distal end of the release rod 62 passes through the fixing hole 611 and is inserted into the insertion hole 42, thereby fixing the implantation anchor 61 on the second clamping surface 41 of the second clamping arm 40. When the second clamping arm 40 is in the initial closed state relative to the first clamping arm 30, the artificial leaflet 72 is clamped between the first clamping surface 31 and the second clamping surface 41; when the second clamping arm 40 is opened relative to the first clamping arm 30, the artificial leaflet 72 opens along with the second clamping arm 40 relative to the first clamping arm 30, that is, a space for accommodating the original leaflet 71 to be enhanced is formed between the artificial leaflet 72 and the first clamping surface 31. Figures 2 to 5 , Figure 7 , Figure 10 and Figure 12 As shown, the first puncture structure 91 includes a fastening member 911, and the first clamping arm 30 is provided with a guide groove 34, which extends to the first clamping surface 31. The fastening member 911 is slidably installed in the guide groove 34. Furthermore, the driving assembly is driven to connect with the fastening member 911, and the driving assembly drives the fastening member 911 to slide out of the guide groove 34 to puncture the native leaflet 71 and the artificial leaflet 72 and connect to the implantation anchor 61.

[0039] Specifically, such as Figure 2As shown, the drive assembly includes a second drive rod 912 and a drive block 913. The distal end of the second drive rod 912 is fixedly connected to the drive block 913, and the proximal end of the second drive rod 912 is connected to the handle assembly 21. The drive block 913 is slidably mounted on the first clamping arm 30 along the extension direction of the first clamping arm 30. The drive block 913 is provided with a drive inclined surface 9131. The other end of the guide groove 34 extends through the space where the drive block 913 is located, and the fastener 911 abuts against the drive inclined surface 9131. When the native leaflet 71 and the artificial leaflet 72 are stacked and stably held by the first clamping surface 31 and the second clamping surface 41, and the native leaflet 71 covers the implanted anchor 61, the operator will operate the handle assembly 21 to drive the second drive rod 912 of the drive assembly towards the proximal end. The second drive rod 912 pulls the drive block 913 to slide towards the proximal end. Since the fastening member 911 abuts against the drive ramp 9131 of the drive block 913, the drive ramp 9131 will drive the fastening member 911 to move towards the second clamping surface 41. Figure 2 , Figure 12 As shown, the fastening member 911 includes a fastening plate 9111 and a piercing pin 9112. The piercing pin 9112 includes a pin shank 9114 connected to the fastening plate 9111 at one end and a pin head 9113 connected to the other end of the pin shank 9114. The implantation anchor 61 is provided with an anchor hole 612 that can elastically deform and open and close. When the fastening member 911 is driven by the driving inclined surface 9131 to move towards the second clamping surface 41, the pin head 9113 pierces the original leaflet 71 and the artificial leaflet 72. Then, the pin head 9113 opens and passes through the anchor hole 612, and the elastically contracting anchor hole 612 prevents the pin head 9113 from coming out. This completes the piercing connection operation of the middle region 73 of the original leaflet 71 and the artificial leaflet 72, as shown. Figure 11 The diagram shows the central region 73 of the native leaflet 71 and the artificial leaflet 72 being connected by the implanted anchor 61 and the fastener 911. The operator then continues to operate the release lever 62, causing the distal end of the release lever 62 to disengage from the insertion hole 42 and the fixing hole 611 of the implanted anchor 61, allowing the implanted anchor 61 to detach from the second clamping arm 40. Next, the operator operates the handle assembly 21 again, driving the first drive lever 221 to open the second clamping arm 40 relative to the first clamping arm 30, thereby releasing the native leaflet 71 and the artificial leaflet 72. When the native leaflet 71, the artificial leaflet 72, and the puncture assembly 90 have disengaged from the clamping space between the first clamping arm 30 and the second clamping arm 40, the second clamping arm 40 is closed again, allowing the leaflet clamping device to be withdrawn.

[0040] Furthermore, in some embodiments of the leaflet enhancement device, such as Figures 2 to 7 , Figure 10 , Figure 14 and Figure 15As shown, the clamping assembly also includes an auxiliary clamping arm 50, which is rotatably mounted on the first clamping arm 30. The auxiliary clamping arm 50 is provided with an auxiliary clamping part 51. The driving assembly is driven to connect with the auxiliary clamping arm 50 to drive the auxiliary clamping arm 50 to open or close relative to the first clamping arm 30. When the second clamping arm 40 is open, the driving assembly drives the auxiliary clamping arm 50 to move toward the second clamping arm 40 so that the auxiliary clamping part 51 can abut against the second clamping surface 41. During the clamping process of the original leaflet 71, when the driving assembly drives the second clamping arm 40 to open relative to the first clamping arm 30 (e.g., Figure 3 (as shown), and cause the native leaflet 71 to enter between the first clamping surface 31 and the second clamping surface 41 (as shown). Figure 4 When (as shown), the operator operates the handle assembly 21 to drive the drive assembly to move the auxiliary clamping arm 50 toward the second clamping surface 41 of the second clamping arm 40, until the auxiliary clamping part 51 contacts the original leaflet 71 and clamps it on the surface of the artificial leaflet 72 facing away from the second clamping surface 41, as shown. Figure 5 As shown, at this time, the second clamping surface 41 and the artificial leaflet 72 thereon support the original leaflet 71, while the auxiliary clamping arm 50 applies force to the original leaflet 71 to clamp it onto the second clamping surface 41. Then, the operator continues to operate the handle assembly 21 to drive the drive assembly to simultaneously drive the second clamping arm 40 and the auxiliary clamping arm 50 towards the first clamping arm 30 to close. During this process, the second clamping arm 40 and the auxiliary clamping arm 50 maintain a clamping state on the original leaflet 71 until the original leaflet 71 is moved onto the first clamping surface 31, that is, the first clamping surface 31 and the second clamping surface 41 stably clamp the original leaflet 71 to be reinforced. Figure 6 As shown. During the process of pushing the original leaflet 71 towards the first clamping surface 31, the second clamping surface 41 and the auxiliary clamping part 51 of the auxiliary clamping arm 50 keep the original leaflet 71 in a clamping state, achieving a preliminary clamping and stabilizing effect on the original leaflet 71. This reduces the possibility of the original leaflet 71 slipping due to blood flow impact and tissue elasticity during the process of being pushed towards the first clamping surface 31, which is conducive to improving the clamping success rate of the original leaflet 71, reducing the number of repeated clamping operations, thereby reducing the operation time and thus reducing the surgical risk to a certain extent.

[0041] Furthermore, the auxiliary clamping arm 50 is provided with a clearance channel 52. When the auxiliary clamping arm 50 is closed, the clearance channel 52 is directly opposite the guide groove 34. On the one hand, by clearing the first clamping surface 31 through the clearance channel 52, the auxiliary clamping arm 50 can smoothly open or close between the first clamping arm 30 and the open second clamping arm 40, avoiding motion interference between the first clamping surface 31 and the auxiliary clamping arm 50. On the other hand, by setting the clearance channel 52, the size and weight of the auxiliary clamping arm 50 are reduced, which is conducive to the overall lightweight optimization design of the leaflet clamping device.

[0042] like Figure 14 and Figure 15 As shown, the auxiliary clamping arm 50 has two opposing rotating posts 53, which are rotatably mounted on the first clamping arm 30. The drive assembly is driven to the proximal end of the auxiliary clamping arm 50, and the operator can drive the auxiliary clamping arm 50 to open or close relative to the first clamping arm 30 by operating the handle assembly 21. Furthermore, the auxiliary clamping part 51 is provided at the distal end of the auxiliary clamping arm 50. When the drive assembly drives the auxiliary clamping arm 50 to move toward the second clamping arm 40 to open, the distal end of the auxiliary clamping arm 50 (i.e., the auxiliary clamping part 51) can abut against the side surface of the artificial leaflet 72 facing away from the second clamping surface 41, thereby clamping the original leaflet 71 to be reinforced onto the second clamping surface 41. Thus, during the process of pushing the original leaflet 71 toward the first clamping surface 31, the second clamping surface 41 and the auxiliary clamping part 51 are always in a clamping state on the original leaflet 71, achieving the effect of initial clamping and stabilizing the original leaflet 71, reducing the possibility that the original leaflet 71 may slip off the second clamping surface 41 due to blood flow impact and tissue elasticity during the process of being pushed toward the first clamping surface 31, which is conducive to improving the clamping success rate of the original leaflet 71.

[0043] And, as Figures 2 to 5 As shown, the first clamping arm 30 is provided with a receiving groove 32. When the auxiliary clamping arm 50 is closed, the auxiliary clamping arm 50 is accommodated in the receiving groove 32. Thus, when the first clamping arm 30, the second clamping arm 40, and the auxiliary clamping arm 50 are closed and hugged together, the auxiliary clamping arm 50 sinks into the receiving groove 32, making the volume of the first clamping arm 30, the second clamping arm 40, and the auxiliary clamping arm 50 as compact as possible and smaller in size. Furthermore, the distal end of the head member 35 is designed with a rounded and smooth head, which can reduce the propulsion resistance in the body and facilitate smooth propulsion in the body, thereby smoothly reaching the original leaflet 71 of the heart to be reinforced.

[0044] Furthermore, such as Figures 3 to 7 , Figure 10As shown, the drive assembly includes a third drive rod 222, which passes through the catheter component 10. One end of the third drive rod 222 is connected to the handle assembly 21, and the other end is rotatably connected to the proximal end of the auxiliary clamping arm 50. In this embodiment, the rotating column 53 is located between the proximal and distal ends of the auxiliary clamping arm 50. Thus, when the operator operates the handle assembly 21, the third drive rod 222 moves, driving the proximal end of the auxiliary clamping arm 50, thereby allowing the auxiliary clamping arm 50 to open or close relative to the first clamping arm 30. When the auxiliary clamping arm 50 is open relative to the first clamping arm 30, the distal end of the auxiliary clamping arm 50 (i.e., the auxiliary clamping part 51) can abut against the surface of the artificial leaflet 72 facing away from the second clamping surface 41, thereby enabling initial clamping and stabilization of the native leaflet 71.

[0045] like Figure 15 As shown, at least the auxiliary clamping part 51 of the auxiliary clamping arm 50 is provided with a first anti-slip structure 54, and at least a portion of the first anti-slip structure 54 can abut against the second clamping surface 41. Thus, when the auxiliary clamping arm 50 moves toward the second clamping surface 41 and clamps the original leaflet 71 on the side surface of the artificial leaflet 72 facing away from the second clamping surface 41, the first anti-slip structure 54 is in direct contact with the original leaflet 71, which can effectively reduce the possibility of the original leaflet 71 slipping out, thereby initially clamping and stabilizing the original leaflet 71 on the side surface of the artificial leaflet 72 facing away from the second clamping surface 41. Then, the second clamping arm 40 and the auxiliary clamping arm 50 move toward the first clamping arm 30 while holding the original leaflet 71, until the second clamping surface 41 of the second clamping arm 40 and the first clamping surface 31 of the first clamping arm 30 hold the original leaflet 71 and the artificial leaflet 72 (at this time, the auxiliary clamping arm 50 will sink into the receiving groove 32), which improves the success rate and clamping stability of holding the original leaflet 71.

[0046] In some feasible embodiments, the auxiliary clamping arm 50, from the connection point between the auxiliary clamping arm 50 and the first clamping arm 30 to the auxiliary clamping part 51, may be provided with a first anti-slip structure 54 throughout, or most of this part may be provided with a continuous first anti-slip structure 54, and the first anti-slip structure 54 may cover the entire auxiliary clamping part 51. In this way, during the opening process of the auxiliary clamping arm 50 relative to the first clamping arm 30, the original leaflet 71 is always in contact with the first anti-slip structure 54 to prevent the original leaflet 71 from slipping out of the space between the auxiliary clamping arm 50 and the second clamping arm 40, until the auxiliary clamping part 51 clamps the original leaflet 71, thereby improving the success rate of initially clamping and stabilizing the original leaflet 71 on the side surface of the artificial leaflet 72 facing away from the second clamping surface 41.

[0047] Furthermore, such as Figure 3 , Figure 4 , Figure 7 , Figure 10 As shown, the first clamping surface 31 is provided with a second anti-slip structure 33. When the auxiliary clamping arm 50 is closed, the second anti-slip structure 33 can abut against the side surface of the artificial leaflet 72 facing away from the second clamping surface 41. That is, when the second clamping surface 41 of the second clamping arm 40 and the first clamping surface 31 of the first clamping arm 30 clamp the original leaflet 71, although the auxiliary clamping arm 50 is sunk into the receiving groove 32, the first anti-slip structure 54 still abuts against the original leaflet 71, and the second anti-slip structure 33 also abuts against the original leaflet 71, thereby further stabilizing the clamping of the original leaflet 71 and reducing the possibility of the original leaflet 71 slipping out.

[0048] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A leaflet enhancement device, characterized in that, include: catheter components; A drive mechanism includes a handle assembly and a drive assembly, the handle assembly being disposed at the proximal end of the catheter member, and the drive assembly being connected to the handle assembly and passing through the catheter member; The clamping assembly includes a first clamping arm and a second clamping arm. The first clamping arm is located at the distal end of the catheter component. The proximal end of the second clamping arm is rotatably connected to the proximal end of the first clamping arm or the distal end of the catheter component. The driving assembly is drivenly connected to the second clamping arm to drive the second clamping arm to open or close relative to the first clamping arm. The first clamping arm has a first clamping surface, and the distal end of the second clamping arm has a second clamping surface. When the second clamping arm is closed, the second clamping surface can adapt to contact the first clamping surface to clamp the native leaflet. Artificial leaflets can be detachably connected to the second clamping arm and abut against the second clamping surface; The puncture assembly includes a first puncture structure and a second puncture structure. The first puncture structure is disposed between the catheter member and the first clamping arm, and the second puncture structure is disposed through the catheter member. When the second clamping arm is closed, the first puncture structure punctures and connects the middle region of the native leaflet and the artificial leaflet. Then, when the second clamping arm, the artificial leaflet, and the native leaflet are all open, the second puncture structure punctures and connects the native leaflet and the artificial leaflet in the side region of at least one of the two sides of the second clamping arm.

2. The leaflet enhancement device according to claim 1, characterized in that, The number of the second puncture structures is two. Along the direction perpendicular to the catheter component, the two second puncture structures are arranged side by side, and the two second puncture structures respectively puncture the side areas on both sides of the second clamp arm connecting the original leaflet and the artificial leaflet.

3. The leaflet enhancement device according to claim 1, characterized in that, The second puncture structure includes a puncture needle, a push rod, and an anchoring member. The puncture needle has a channel passing through its distal and proximal ends. The push rod passes through the channel, and the anchoring member is slidably disposed in the channel. The anchoring member is detachably connected to the distal end of the push rod. When the puncture needle punctures the original leaflet and the artificial leaflet, the push rod pushes the anchoring member to slide out of the channel and connect the side regions of the original leaflet and the artificial leaflet.

4. The leaflet enhancement device according to claim 3, characterized in that, The anchoring component includes a first anchoring block, a second anchoring block, and an elastic connecting line. The first anchoring block or the second anchoring block is detachably connected to the distal end of the push rod. The two ends of the elastic connecting line are respectively fixedly connected to the middle of the first anchoring block and the middle of the second anchoring block. Both the first anchoring block and the second anchoring block can be slidably disposed in the channel. The length direction of the first anchoring block and the length direction of the second anchoring block are consistent with the extension direction of the channel. Furthermore, the first anchoring block and the second anchoring block clamp the original leaflet and the artificial leaflet under the elastic tension of the elastic connecting line.

5. The leaflet enhancement device according to claim 4, characterized in that, The far end of the push rod is provided with a first buckle, and one end of the first anchor block or one end of the second anchor block is provided with a second buckle adapted to the first buckle. The first buckle and the second buckle are detachably fastened together.

6. The leaflet enhancement device according to claim 5, characterized in that, The first anchor block has a first mounting hole in its middle, and the axis of the first mounting hole is perpendicular to the length direction of the first anchor block. The second anchor block has a second mounting hole in its middle, and the axis of the second mounting hole is perpendicular to the length direction of the second anchor block. Furthermore, the orientation of the opening of either the first mounting hole or the second mounting hole is opposite to the orientation of the opening of the second buckle.

7. The leaflet enhancement device according to claim 6, characterized in that, The first anchor block is further provided with a third mounting hole, the extension direction of which is consistent with the length direction of the first anchor block, the third mounting hole communicating with the first mounting hole, and one end of the elastic connecting wire passing through the first mounting hole and the third mounting hole in sequence; and / or, The second anchor block is also provided with a fourth mounting hole. The extension direction of the fourth mounting hole is consistent with the length direction of the second anchor block. The fourth mounting hole is connected to the second mounting hole. The other end of the elastic connecting line passes through the second mounting hole and the fourth mounting hole in sequence.

8. The leaflet enhancement device according to any one of claims 1-7, characterized in that, The distal end of the catheter component is provided with a guide slope, which is connected to the distal outlet of the installation channel for passing through the second puncture structure. The guide slope is inclined from the proximal end to the distal end of the catheter component in a direction away from the central axis of the catheter component.

9. The leaflet enhancement device according to any one of claims 1-7, characterized in that, The leaflet enhancement device further includes an implantation anchor and a release rod. The implantation anchor is fixedly disposed with the artificial leaflet. The implantation anchor has a fixing hole on the side opposite to the artificial leaflet. The second clamping arm has an insertion hole corresponding to the fixing hole. The release rod passes through the catheter component. The distal end of the release rod passes through the fixing hole and is inserted into the insertion hole. The first puncture structure includes a fastening member, the first clamping arm is provided with a guide groove, the guide groove extends to the first clamping surface, the fastening member is slidably installed in the guide groove, the driving component is drivenly connected to the fastening member, and the driving component drives the fastening member to slide out of the guide groove to puncture the original leaflet and the artificial leaflet and connect to the implantation anchor.

10. The leaflet enhancement device according to claim 9, characterized in that, The clamping assembly further includes an auxiliary clamping arm, which is rotatably mounted on the first clamping arm. The auxiliary clamping arm has an auxiliary clamping part. The driving assembly is driven to the auxiliary clamping arm to drive the auxiliary clamping arm to open or close relative to the first clamping arm. When the second clamping arm is open, the driving assembly drives the auxiliary clamping arm to move toward the second clamping arm so that the auxiliary clamping part can abut against the second clamping surface. Furthermore, the auxiliary clamping arm has a clearance channel. When the auxiliary clamping arm is closed, the clearance channel is directly opposite the guide groove.

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