Repair clamp for treating valve regurgitation

Abstract

The invention relates to the field of medical instruments, in particular to a repair clamp for treating valve regurgitation, a conveying device and a repair clamp detachably connected with the conveying device.The repair clamp comprises a first clamping arm, a second clamping arm and a locking mechanism, and the first clamping arm and the second clamping arm are connected and can form a clamping area; the locking mechanism comprises a restraining piece capable of being tightened, the restraining piece penetrates through the connecting structure on the repair clamp, and the restraining piece can limit relative movement of the clamping arms in the tightened state. The conveying device is detachably connected with the repair clamp and is configured to be capable of conveying the repair clamp to a target heart valve and assisting the repair clamp to be opened or closed so that a target valve leaflet tissue part can be contained in the clamping area; after being folded and used for clamping the valve leaflets, the repair clamp cannot be exposed out of the involution faces of the valve leaflets, damage caused by collision between adjacent valve leaflets and an instrument when the valve is closed is avoided, the number of the repair clamp is reduced, and the load on valve leaflet movement is relieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a repair clamp for treating valve regurgitation. BACKGROUND

[0002] Traditional surgical treatment of posterior leaflet prolapse of the mitral valve can be divided into leaflet level surgical methods, commonly used folding (McGoon technique) and resection (triangular resection, quadrangular resection, sliding plasty or wedge resection). Among surgical methods, typical open chest and open heart surgery has too large invasiveness, needs to establish extracorporeal circulation, has a high complication rate and infection risk, and many patients cannot tolerate the huge surgical risk and can only wait for death helplessly.

[0003] The existing mature valve repair technology of intervention type is mainly the leaflet edge-to-edge clamping technology. This technology changes the original physiological structure of the valve, and has a large reduction in the effective opening area of the valve and a serious impact on secondary intervention surgery.

[0004] For example, patent application CN 107438409 B discloses a minimally invasive transcatheter leaflet folding repair device, which comprises a grabbing forceps (1) and a folding forceps (2). The grabbing forceps (1) is suitable for grabbing the leaflet edge (3). The folding forceps (2) comprises two rotatable flaps (4, 5) and a central shaft (6). The flaps (4, 5) can rotate around the central shaft in a "butterfly way" so that the folding forceps (2) can adopt a closed or open configuration. The present application also relates to a method for using the medical device. The device can complete the leaflet folding function to reduce the opening area of the valve and achieve the purpose of repairing the valve. However, the patent solution can only be used for surgical operation, which has a large surgical trauma to the patient. Secondly, the area of leaflet resection depends on the size of the flap, and the corresponding adjustment cannot be made according to the patient's anatomical structure during the operation, which leads to the fact that the device is not universally applicable to different patients.

[0005] The patent application CN202310002600.0 discloses a minimally invasive transcatheter valve leaflet folding repair device, and belongs to the technical field of medical devices. It comprises a capture clamp, a folding clamp, a pulling mechanism and a stop mechanism. One end of the capture clamp is provided with a movable openable clamp arm, and the other end of the capture clamp is provided with a pulling mechanism for pulling the clamp arm. The folding clamp comprises two side wings that can be folded together, and the two side wings are arranged on the two sides of the clamp arm. The two side wings are provided with a detachable stop mechanism for limiting the folding movement of the side wings. In this scheme, the repair device is pressed down by the pulling mechanism in a forward and backward pushing and pulling manner, which results in a larger size of the pulling mechanism and the stop mechanism at the front end, causing the front end to be exposed at the commissure surface of the valve leaflet. When the autologous valve leaflet is coapted, the front end of the repair device will collide with the valve leaflet, causing damage. In addition, the repair device leaves many repair clamps in the heart, which are heavy and have a negative impact on the movement of the valve leaflet.

[0006] In summary, although there are schemes in the prior art to reduce the area of the valve leaflet to reduce the opening area of the valve, there are still limitations in the surgical operation path, the repair device is exposed to the commissure surface of the valve leaflet, causing damage to the valve leaflet, and the repair clamp is too many and heavy, affecting the movement of the valve leaflet. Therefore, it is necessary to improve the repair device to meet the minimally invasive surgical method, and to achieve valve repair without causing damage to the remaining valve leaflet or affecting its movement form, so as to meet the clinical needs. SUMMARY

[0007] The present application is proposed in view of the above and other more ideas.

[0008] One of the purposes of the present application is to overcome the shortcomings of the prior art, and to provide a repair clamp for treating valve regurgitation, which addresses the problems such as the repair device being limited to the surgical operation path or causing collision damage to the valve leaflet tissue after implantation and affecting the movement form of the valve leaflet.

[0009] The technical scheme adopted to solve the technical problems of the present application is to provide a repair clip for treating valve regurgitation, comprising: a delivery device and a repair clip detachably connected with the delivery device, the repair clip comprising a first clamping arm, a second clamping arm and a locking mechanism, wherein the first clamping arm and the second clamping arm are connected and can be opened and closed relative to each other to form a clamping area for clamping tissue, the locking mechanism comprises at least one tightening constraint, the constraint passes through the connecting structure on the repair clip, and the constraint can limit the relative movement of the first clamping arm and the second clamping arm in the tightened state to lock the closed state of the repair clip; the delivery device is detachably connected with the repair clip, the delivery device comprises an auxiliary clamping device and a leaflet manipulation mechanism; wherein the auxiliary clamping device is configured to be detachably connected with the implant, and the auxiliary clamping device can be actuated and controlled to open and close the implant; the leaflet manipulation mechanism is configured to operate independently of the auxiliary clamping device to allow the target leaflet tissue to be included in the anchor region by pushing or lifting the leaflet tissue towards the anchor region.

[0010] As a further improvement of the present application, the constraint is connected with a locking line, the locking line extends to the operating end of the delivery device, and the constraint can be tightened by operating the locking line, thereby realizing the locking of the repair clip.

[0011] As a further improvement of the present application, the delivery device is provided with a tube, the locking line passes through the tube and is connected with the constraint, and after the locking operation is completed, the locking line and the constraint can be disconnected by a detachable knot or a line cutter.

[0012] As a further improvement of the present application, the constraint is a closed-loop flexible coil, and the locking mechanism forms an irreversible locking state after the constraint is tightened.

[0013] As a further improvement of the present application, the first clamping arm and the second clamping arm are connected in a hinged form, wherein the first clamping arm and the second clamping arm are provided with hollowed-out areas; since the locking structure can lock the locking state of the repair clip, the rigidity of the first clamping arm and the second clamping arm can be appropriately reduced, so the hollowed-out areas are designed on the first clamping arm and the second clamping arm, which can further reduce the weight of the repair clip and reduce the influence on the movement of the native leaflet after implantation.

[0014] As a further improvement of the present application, the connecting structure on the repair clip is a connecting rod or a connecting hole, and the connecting rod or the connecting hole is respectively arranged on the first clamping arm and the second clamping arm; in a preferred embodiment, the connecting structure is a connecting hole.

[0015] As a further improvement of the application, when the repair clip is in the open state, the first clamping arm and the second clamping arm form a leaflet holding platform to hold the target leaflet tissue; wherein the first clamping arm and the second clamping arm are further provided with an expansion component, the expansion component has a three-dimensional structure to increase the holding area of the leaflet holding platform, and the expansion component is made of a material with a developing function or carries a developing mark.

[0016] As a further improvement of the application, the first clamping arm and the second clamping arm are foldable multi-section arm structures, and the first clamping arm and the second clamping arm are L-shaped structures to form a leaflet holding platform.

[0017] As a further improvement of the application, the repair clip is made of a memory metal material and is integrally formed, such as nickel-titanium alloy; of course, a high polymer material can also be used, which can further reduce the weight of the repair clip and reduce the influence on the leaflet movement.

[0018] As a further improvement of the application, after implantation, all structures of the repair clip are located on the non-opposing surface of the target leaflet tissue (the leaflet can be divided into the opposing surface and the non-opposing surface, wherein the opposing surface refers to the surface of the adjacent leaflets in contact and attached when the valve is closed, and the non-opposing surface refers to the surface between the adjacent leaflets that cannot be contacted, for example, for atrioventricular valves, the non-opposing surface refers to the surface of the leaflet facing the ventricular wall, and for aortic valves, the non-opposing surface refers to the surface facing the aortic vessel wall); the advantage of such design is that after the valve repair device is implanted, when the autologous valve changes from an open state to a closed state, the valve repair device will not collide with the adjacent leaflet, thereby avoiding damage to the adjacent leaflet.

[0019] As a further improvement of the application, the delivery device comprises an auxiliary clamping device and an actuating control mechanism, wherein the auxiliary clamping device is detachably connected with the repair clip, and the actuating control mechanism is configured to manipulate the auxiliary clamping device to perform opening and closing actions, thereby driving the repair clip to open and close synchronously.

[0020] As a further improvement of the application, the delivery device comprises a leaflet manipulation mechanism, the leaflet manipulation mechanism comprises a pre-fixing assembly and a pushing assembly; wherein the pre-fixing assembly is configured to cooperate with the auxiliary clamping device to pre-fix the target leaflet tissue; the pushing assembly is configured to push the pre-fixed target leaflet tissue into the clamping area of the repair clip after the pre-fixing assembly completes the pre-fixing of the leaflet.

[0021] As a further improvement of the present application, the actuating control mechanism comprises a driving screw, a driving nut sleeved on the driving screw, a linkage rod connecting the driving nut with the first and second clamping arms, and a meshing sleeve sleeved on the driving screw, which is configured to selectively engage or disengage with the driving nut, wherein when the meshing sleeve engages with the driving nut, rotating the driving screw can drive the driving nut to produce axial displacement, which in turn drives the repair clamp to perform opening and closing actions through the linkage rod.

[0022] As a further improvement of the present application, the distal end of the driving screw is provided with a threaded structure, the driving nut is sleeved on the threaded structure, and the axial movement of the driving nut is achieved by rotating the driving screw to fix the meshing sleeve with the driving nut, so that the driving screw can drive the auxiliary clamp closing device and the repair clamp to open and close through the linkage rod.

[0023] As a further improvement of the present application, the meshing sleeve and the driving nut are engaged through a buckle structure, and the linkage rod is connected with the driving nut and the auxiliary clamp closing device in a hinged manner.

[0024] As a further improvement of the present application, the conveying device further comprises a control wire for connecting and dismounting the repair clamp and the auxiliary clamp closing device, wherein the repair clamp and the auxiliary clamp closing device are both provided with a dismounting hole, the inside of the driving screw is hollow, and the control wire passes through the inside of the driving screw and the dismounting hole to form a connection between the repair clamp and the auxiliary clamp closing device, and when the control wire is pulled out of the dismounting hole, the repair clamp and the auxiliary clamp closing device are separated.

[0025] As a further improvement of the present application, the pre-fixing assembly comprises at least one leaflet pressing spring, and the pushing assembly comprises a pushing rod and a set of thrust arms arranged at the distal end of the pushing rod, which are configured to spread in the circumferential direction; wherein the leaflet pressing spring is provided with a guide hole, when the target leaflet tissue is pre-fixed, the pushing rod passes through the guide hole along a predetermined path, at this time, the thrust piece is reversely folded by the guide hole until the pushing rod completes the pushing and retracts, the thrust piece provides a reverse thrust force towards the proximal end for the pushing rod. The thrust piece can increase the contact area with the leaflet tissue, and can provide a reverse thrust force when the pushing rod retracts, assisting the pushing rod to separate from the anchoring area.

[0026] As a further improvement of the application, after the repair clip is folded and clamps the leaflet tissue, the surgeon can remove the engagement sleeve and the leaflet manipulation mechanism from the heart, and can observe the coaptation of the leaflet and the blood regurgitation through the imaging device. If further adjustment is needed, the surgeon can push the engagement sleeve along the drive screw and re-engage it with the drive nut, control the auxiliary clamping device and the repair clip to open by operating the drive screw, and re-push part of the leaflet tissue by operating the leaflet manipulation mechanism until an ideal coaptation state of the leaflet is achieved. At this time, the control wire can be removed, the delivery device is separated from the repair clip, only the repair clip remains in the heart, which greatly reduces the amount of repair clip and the weight burden on the leaflet. In addition, the reversible adjustment mode also greatly increases the fault tolerance of the device. The surgeon can perform multiple operations and observe through the imaging device to adjust it to an ideal state.

[0027] As a further improvement of the application, taking mitral valve repair as an example, the specific operation steps of the heart valve repair device of the application are as follows: 1. The valve repair device is loaded in the sheath of the delivery device, at this time, the auxiliary clamping device and the repair clip are in the folded configuration, loaded in the delivery sheath, and the delivery sheath is inserted into the left atrium through the fossa ovalis; 2. The delivery sheath advances, the auxiliary clamping device is in the folded configuration, after the delivery sheath is bent, the valve repair device enters the left ventricle; 3. The auxiliary clamping device holds the leaflet, the pre-fixing assembly is operated to cooperate with the clamping arm to press the leaflet, and the actuation control mechanism is operated to open the auxiliary clamping device and the repair clip, the push rod and its thrust arm push the leaflet tissue into the clamping area of the repair clip; 4. The push rod and its thrust arm are removed, and the pre-fixing assembly is pulled up, the drive screw is rotated to close the auxiliary clamping device and the repair clip; 5. The engagement sleeve and the push assembly are removed, and the effect of the device is evaluated through the imaging device to determine whether further adjustment is needed; 6. If the device works well, the control wire is removed from the connection hole to separate the implant from the delivery device, the delivery device is removed from the body, only the repair clip is anchored on the leaflet tissue, and the operation is completed.

[0028] Compared with the prior art, the technical scheme of the application has at least the following advantages: In the prior art, after the repair device clamps and folds the leaflets, part of the device is exposed to the coaptation surface of the leaflets, which causes the leaflets to collide with adjacent leaflets during coaptation, resulting in tissue damage. Moreover, the volume and weight of the repair clip greatly affect the movement of the leaflet tissue, which, over time, places a heavy burden on the leaflets and causes lesions. According to one concept of the present application, the auxiliary clip closing device is used to operate the opening and closing of the repair clip, and the leaflet capturing mechanism and the pushing device push the leaflet tissue into the clamping area of the repair clip. After the repair clip completes the folding and anchoring of the leaflet tissue, the delivery device is withdrawn from the body, leaving only the repair clip in the heart. This scheme can adjust the coaptation state of the leaflets by folding the leaflets to reduce the surface area of the leaflet tissue, thereby repairing the valve. All structures of the repair clip are located on the non-coaptation surface of the leaflets, avoiding collision between the leaflets and adjacent leaflets during coaptation, which causes damage to the leaflets. Moreover, the repair clip is greatly reduced, reducing the burden on the leaflet tissue.

[0029] According to one concept of the present application, the first clamping arm and the second clamping arm are connected in a hinged form and driven by the auxiliary clip closing device to perform opening and closing actions of the repair clip. After the repair clip is closed, the control wire is used to pull the restraint to complete locking, which not only easily opens the repair clip but also maintains a stable locking state. The locking mode of the control wire pulling also effectively transmits the pulling force to the restraint, ensuring the success rate of the locking operation. Moreover, the operation is very convenient and the structure is simple.

[0030] According to one concept of the present application, the locking of the repair clip is completed in a knot form, which does not additionally increase the weight of the repair clip, so that the repair clip of the present application has little effect on the coaptation movement of the native leaflets after anchoring the leaflets.

[0031] According to one concept of the present application, the clamping arm is provided with an expansion component. The expansion component not only expands the leaflet holding platform to support larger area of leaflet tissue, but also has a developing function, which facilitates the surgeon to determine the specific position of the device during the operation and provides convenience for the operation.

[0032] According to one concept of the present application, the valve repair device uses the method of reducing the surface area of the leaflets to adjust the coaptation state of the leaflets, thereby repairing the valve. This concept not only achieves the repair effect of valve regurgitation, but also does not interfere with the long-term valve replacement surgery or annuloplasty treatment scheme.

[0033] The embodiments of the present application can achieve other advantageous technical effects not listed one by one, some of which are described below, and which can be expected and understood by those skilled in the art after reading the present application. BRIEF DESCRIPTION OF DRAWINGS

[0034] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1 , Figure 2 , Figure 3 This is a schematic diagram of the repair clip of the present invention.

[0035] Figure 4 , Figure 5 , Figure 6 This is a schematic diagram of the delivery device entering the heart in this invention.

[0036] Figures 7 to 11 This is a schematic diagram of the operation process of the repair clip of the present invention.

[0037] Figure 12 This is a schematic diagram of the final implantation of the repair clip in this invention.

[0038] The features represented by the numbers in the attached diagram are as follows: 1-Repair clamp, 11-First clamping arm, 12-Second clamping arm, 13-Locking mechanism, 131-Constraint, 14-Clamping area, 15-Connecting structure, 2-Conveying device, 21-Locking line, 22-Auxiliary clamping device, 23-Actuation control mechanism, 231-Drive screw, 232-Drive nut, 233-Linkage rod, 234-Engaging sleeve, 24-Leaf manipulation mechanism, 241-Pre-fixing assembly, 2411-Pressure flap spring, 2412-Push rod, 2413-Thrust arm, 242-Push assembly. Detailed Implementation

[0039] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0040] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0041] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0042] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0043] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0044] Example 1: This example uses mitral valve repair as an example. Figure 1 , Figure 2 and Figure 3 As shown, a repair clip 1 for treating valvular regurgitation includes a delivery device 2 and a repair clip 1 detachably connected to the delivery device 2. The repair clip 1 includes a first clamping arm 11, a second clamping arm 12, and a locking mechanism 13. The first clamping arm 11 and the second clamping arm 12 are connected and can be opened and closed relative to each other to form a clamping area 14 for clamping tissue. The locking mechanism 13 includes at least one retractable restraint 131, which passes through a connecting structure 15 on the repair clip 1. 1. A device capable of restricting the relative movement of the first clamping arm 11 and the second clamping arm 12 in a tightened state to lock the repair clip 1 in a closed state; 2. A delivery device 2 detachably connected to the repair clip 1 and configured to: deliver the repair clip 1 to the target heart valve and assist the repair clip 1 in opening or closing so that the target leaflet tissue is included in the clamping area 14 of the repair clip 1, and after the repair clip 1 is anchored, the delivery device 2 is disconnected from the repair clip 1 and released.

[0045] In this embodiment, as Figure 2 As shown, the constraint member 131 is connected to a locking line 21, which extends to the operating end of the conveying device 2. By operating the locking line 21, the constraint member 131 can be tightened, thereby locking the repair clip 1.

[0046] In this embodiment, as Figure 2 As shown, the conveying device 2 is provided with a pipe fitting, the locking line 21 passes through the pipe fitting and is connected to the constraint member 131. After the locking operation is completed, the locking line 21 and the constraint member 131 can be disconnected by the provided detachable knot, or the connection can be disconnected by the wire cutter.

[0047] In this embodiment, the constraint member 131 is a closed-loop flexible coil, and the locking mechanism 13 forms an irreversible locked state after the constraint member 131 is tightened.

[0048] In this embodiment, the first clamping arm 11 and the second clamping arm 12 are connected in a hinged manner. The first clamping arm 11 and the second clamping arm 12 are provided with hollow areas (not shown). Since the locking structure can lock the repair clip 1 in a locked state, the rigidity of the first clamping arm 11 and the second clamping arm 12 can be appropriately reduced. Therefore, hollow areas (not shown) are designed on the first clamping arm 11 and the second clamping arm 12, which can further reduce the weight of the repair clip 1 and reduce the impact on the movement of the original leaflet after implantation.

[0049] In this embodiment, the connecting structure 15 on the repair clip 1 is a connecting rod with holes in the first clamping arm 11 and the second clamping arm 12, eliminating the need for additional rods and further reducing the weight of the repair clip 1.

[0050] In this embodiment, when the repair clip 1 is in the open state, the first clamping arm 11 and the second clamping arm 12 form a leaflet support platform to support the target leaflet tissue; wherein, the first clamping arm 11 and the second clamping arm 12 are also provided with an extension component (not shown), the extension component (not shown) has a three-dimensional spherical shape to increase the support area of ​​the leaflet support platform, and the extension component (not shown) is made of a material with imaging function, such as tantalum metal.

[0051] In this embodiment, the first clamping arm 11 and the second clamping arm 12 are foldable multi-segment arm structures, and the first clamping arm 11 and the second clamping arm 12 are L-shaped structures to form a leaflet support platform.

[0052] In this embodiment, the repair clip 1 is made of shape memory metal material and integrally formed, such as nickel-titanium alloy.

[0053] In this embodiment, after implantation, all structures of the repair clip 1 are located on the non-occlusive surface of the target leaflet tissue.

[0054] In this embodiment, the conveying device 2 includes an auxiliary clamping device 22 and a leaflet manipulation mechanism 24. The auxiliary clamping device 22 includes an auxiliary clamping device 22 and an actuation control mechanism 23. The auxiliary clamping device 22 is detachably connected to the repair clip 1. The actuation control mechanism 23 is configured to manipulate the auxiliary clamping device 22 to perform opening and closing actions, thereby driving the repair clip 1 to open and close synchronously. The conveying device 2 includes a leaflet manipulation mechanism 24, which includes a pre-fixing component 241 and a pushing component 242. The pre-fixing component 241 is configured to cooperate with the auxiliary clamping device 22 to pre-fix the target leaflet tissue. The pushing component 242 is configured to push the pre-fixed target leaflet tissue into the clamping area 14 of the repair clip 1 after the pre-fixing component 241 has completed the pre-fixation of the leaflet.

[0055] In this embodiment, the actuation control mechanism 23 includes a drive screw 231, a drive nut 232 sleeved on the drive screw 231, a linkage rod 233 connecting the drive nut 232 with the first clamping arm 11 and the second clamping arm 12, and an engagement sleeve 234 sleeved on the drive screw 231. The engagement sleeve 234 is configured to selectively engage or disengage with the drive nut 232. When the engagement sleeve 234 engages with the drive nut 232, rotating the drive screw 231 can drive the drive nut 232 to generate axial displacement, thereby driving the repair clamp 1 to perform opening and closing actions through the linkage rod 233.

[0056] In this embodiment, the conveying device 2 further includes a control wire for manipulating the connection and disconnection of the repair clamp 1 and the auxiliary clamping device 22. Both the repair clamp 1 and the auxiliary clamping device 22 have disassembly holes. The drive screw 231 is hollow internally. The control wire passes through the interior of the drive screw 231 and the disassembly holes to connect the repair clamp 1 and the auxiliary clamping device 22. When the control wire is withdrawn from the disassembly holes, the repair clamp 1 separates from the auxiliary clamping device 22. In practical applications, a locking wire 21 is also threaded through the drive screw 231.

[0057] In this embodiment, as Figure 3As shown, the pre-fixation assembly 241 includes at least one valve-pressing spring 2411, and the pushing assembly 242 includes a pushing rod 2412 and a set of thrust arms 2413 disposed at the distal end of the pushing rod 2412. The set of thrust arms 2413 is configured to expand outward in a circumferential direction. The valve-pressing spring 2411 has a guide hole. After the target leaflet tissue is pre-fixed, the pushing rod 2412 passes through the guide hole along a preset path. At this time, the thrust arms are folded in the opposite direction by the guide hole until the pushing rod 2412 completes its push and retracts. The thrust arms provide a counter-thrust force towards the proximal end of the pushing rod 2412. The thrust arms increase the contact area with the leaflet tissue and provide a counter-thrust force when the pushing rod 2412 retracts, assisting the pushing rod 2412 in disengaging from the anchoring area.

[0058] The procedure for implanting a repair clip for treating valvular regurgitation into the left ventricle according to the present invention is as follows: 1. The valve repair device is mounted inside the delivery sheath, such as... Figure 4 and Figure 5 As shown, at this time, both the auxiliary clamping device 22 and the repair clamp 1 are in a retracted configuration, loaded inside the delivery sheath, which passes through the fossa ovalis and enters the left atrium; 2. As Figure 6 As shown, the delivery sheath advances, the auxiliary clamping device 22 is in a retracted configuration, and after the delivery sheath is adjusted, the valve repair device enters the left ventricle; 3. As Figure 7 and Figure 8 As shown, the auxiliary clamping device 22 supports the leaflet, the pre-fixing component 241 is operated to cooperate with the clamping arm to press the leaflet, and the auxiliary clamping device 22 and the repair clamp 1 are opened by operating the auxiliary clamping device 22. The pushing component 242 is operated so that the pushing rod 2412 and its thrust arm 2413 push the leaflet tissue into the clamping area 14 of the repair clamp 1; 4. As Figure 9 As shown, the push rod 2412 and its thrust arm 2413 are removed, and the pre-fixed assembly 241 is pulled up. The drive screw 231 is rotated to close the auxiliary clamping device 22 and the repair clamp 1; 5. The engaging sleeve 234 and the push assembly 242 are removed, and the instrument effect is evaluated by imaging to determine whether further adjustments are needed. Figure 10 As shown; 6. If the instrument works well, remove the control wire from the connection hole to detach the implant from the delivery device 2, remove the delivery device 2 from the body, leaving only the repair clip 1 anchored to the leaflet tissue, thus completing the surgery. Figure 12 As shown; Figure 10 and Figure 11 If the device is not effective, the engagement sleeve 234 can be returned along the path of the drive screw 231 and re-engaged to adjust the device until the desired effect is achieved, and then the conveying device 2 can be removed.

[0059] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A repair clip for treating valvular regurgitation, comprising: A conveying device and a repair clip detachably connected to the conveying device, characterized in that: the repair clip includes a first clamping arm, a second clamping arm, and a locking mechanism, wherein the first clamping arm and the second clamping arm are connected and can be opened and closed relative to each other to form a clamping area for clamping tissue, and the locking mechanism includes at least one retractable constraint member that passes through a connecting structure on the repair clip, and the constraint member can restrict the relative movement of the first clamping arm and the second clamping arm in a tightened state to lock the repair clip in a closed state; A delivery device detachably connected to the repair clip, the delivery device including an auxiliary clamping device and a leaflet manipulation mechanism; wherein the auxiliary clamping device is configured to be detachably connected to the implant and actuate and control the opening and closing of the implant; the leaflet manipulation mechanism is configured to operate independently of the auxiliary clamping device to bring a portion of the target leaflet tissue into the anchoring area by pushing or lifting the leaflet tissue toward the anchoring area of ​​the implant.

2. The repair clip for treating valvular regurgitation according to claim 1, characterized in that: The constraint member is connected to a locking line, which extends to the operating end of the conveying device. By operating the locking line, the constraint member can be tightened, thereby locking the repair clip.

3. The repair clip for treating valvular regurgitation according to claim 1, characterized in that: The constraint element is a closed-loop flexible coil, and the locking mechanism forms an irreversible locked state after the constraint element is tightened.

4. The repair clip for treating valvular regurgitation according to claim 1, characterized in that: The first clamping arm and the second clamping arm are connected in a hinged manner, wherein the first clamping arm and the second clamping arm are provided with hollow areas.

5. The repair clip for treating valvular regurgitation according to claim 1, characterized in that: The connecting structure on the repair clamp is a connecting rod or a connecting hole, which is respectively provided on the first clamping arm and the second clamping arm.

6. The repair clip for treating valvular regurgitation according to claim 1, characterized in that: When the repair clamp is in the open state, the first clamping arm and the second clamping arm form a leaflet support platform to support the target leaflet tissue; wherein, the first clamping arm and the second clamping arm are also provided with an extension component, the extension component having a three-dimensional structure to increase the support area of ​​the leaflet support platform, and the extension component is made of a material with a developing function or carries a developing mark.

7. The repair clip for treating valvular regurgitation according to claim 1, characterized in that: The delivery device includes a leaflet manipulation mechanism, which includes a pre-fixation component and a pushing component; wherein, the pre-fixation component is configured to cooperate with the auxiliary clamping device to pre-fix the target leaflet tissue; the pushing component is configured to push the pre-fixed target leaflet tissue into the clamping area of ​​the repair clip after the pre-fixation component has completed the pre-fixation of the leaflet.

8. The repair clip for treating valvular regurgitation according to claim 6, characterized in that: The actuation control mechanism includes a drive screw, a drive nut sleeved on the drive screw, a linkage rod connecting the drive nut to the first clamping arm and the second clamping arm, and an engagement sleeve sleeved on the drive screw. The engagement sleeve is configured to selectively engage or disengage with the drive nut. When the engagement sleeve engages with the drive nut, rotating the drive screw can drive the drive nut to generate axial displacement, which in turn drives the repair clamp to perform opening and closing actions via the linkage rod.

9. The repair clip for treating valvular regurgitation according to claim 8, characterized in that: The pre-fixing component includes at least one pressure plate, and the pushing component includes a pushing rod and a set of thrust arms disposed at the distal end of the pushing rod, the set of thrust arms being configured to spread out in a circumferential direction.

10. The repair clip for treating valvular regurgitation according to claim 1, characterized in that: After implantation, all structures of the implant are located on the non-occlusive surface of the target leaflet tissue.

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