Locking assembly

Abstract

This invention provides a locking assembly, including a base and a suture locking member movable relative to the base. The base has a bearing surface, and the suture locking member has a suture locking surface that mates with the bearing surface. The suture locking member has an initial position and a suture locking position. In the initial position, a gap is formed between the suture locking surface and the bearing surface to allow one or more sutures to pass through. In the suture locking position, the gap decreases to lock the suture between the suture locking surface and the bearing surface. This locking assembly is not only simple to manufacture but also provides sufficient locking force, thus effectively ensuring the locking effect of the assembly. Therefore, it is beneficial for improving surgical outcomes and promoting the widespread application of locking suture assemblies.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a locking assembly. Background Technology

[0002] With the development of medical technology, interventional minimally invasive surgery has become increasingly common for treating valvular heart disease. In these surgeries, it is often necessary to remotely knot or fix the sutures within the patient's body. Existing technology discloses a suture locking pin for fixing sutures. This pin has a hollow cavity through which the suture passes. The pin can deform under external force to lock the suture within the hollow cavity. However, the locking direction of this existing pin is horizontal, extending along the hollow cavity. Therefore, to ensure sufficient locking force, the pin needs to retain sufficient length. Furthermore, to ensure that multiple deformable teeth are formed after deformation of certain parts of the pin to further guarantee locking force, the thickness of the deformable portion of the pin needs to be strictly controlled. This results in high manufacturing difficulty for the pin and makes it difficult to guarantee the locking force. Summary of the Invention

[0003] The purpose of this invention is to provide a locking assembly that is not only simple to manufacture, but also provides sufficient locking force, thereby effectively ensuring the locking effect of the locking assembly, which is beneficial to improving surgical results and promoting the application of the locking assembly.

[0004] To achieve the above objectives, in a first aspect, the present invention provides a locking assembly, the locking assembly comprising a base and a locking thread member movable relative to the base, the base having a bearing surface, and the locking thread member having a locking thread surface that mates with the bearing surface; the locking thread member having an initial position and a locking thread position, wherein in the initial position, a gap is formed between the locking thread surface and the bearing surface for a thread to pass through, and in the locking thread position, the gap is reduced to lock the thread between the locking thread surface and the bearing surface.

[0005] Secondly, the present invention also provides a locking assembly, the locking assembly including a base and a locking thread member, the locking thread member being rotatably connected to the base about the central axis of the base; the base is provided with a bearing surface, the locking thread member is provided with a locking thread surface, the circumference of the extension direction of the bearing surface and the circumference of the extension direction of the locking thread surface are concentric circles about the central axis, and the locking thread member is rotated toward the base to compress and deform the thread between the locking thread surface and the bearing surface.

[0006] The locking assembly provided by this invention achieves suture locking through the relative movement between the base and the locking element. Since both the base and the locking element are individually machined components, this invention can ensure a suitable locking gap or suture compression deformation by controlling the assembly dimensions between the two components. Compared to existing locking devices using compression pins, this invention is not only easier to manufacture but also ensures sufficient locking force, effectively guaranteeing the locking effect of the locking assembly. Therefore, it is beneficial for improving surgical outcomes and promoting the widespread application of locking assemblies. Attached Figure Description

[0007] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0008] Figure 1 A cross-sectional schematic diagram of the locking assembly in the first embodiment is shown.

[0009] Figure 2 A three-dimensional schematic diagram of the locking assembly in the first embodiment is shown.

[0010] Figure 3 It shows Figure 2 A three-dimensional schematic diagram of the central base.

[0011] Figure 4 a-4b shows Figure 3 Three-dimensional sectional view and side sectional view of the central base.

[0012] Figure 5 It shows Figure 2 A three-dimensional schematic diagram of the center locking component.

[0013] Figure 6 It shows Figure 2 A three-dimensional schematic diagram of the middle end cap.

[0014] Figure 7 a-7b shows Figure 6 Another angle schematic diagram and side sectional view of the middle end cap.

[0015] Figure 8 It shows Figure 2 A three-dimensional sectional view of the central locking assembly.

[0016] Figure 9 a-9b shows Figure 2 Side sectional views of the locking wire component in its initial position and locking wire position.

[0017] Figure 10 It shows Figure 9 b. Schematic diagram of the extension direction of the midline suture.

[0018] Figure 11 a-11b shows Figure 2 A schematic diagram and side sectional view of the second structure of the central base.

[0019] Figure 12 It shows Figure 2 and Figure 11 A schematic diagram of the second structure of the central locking assembly.

[0020] Figure 13 a-13b shows Figure 12 Side sectional views of the locking wire component in its initial position and locking wire position.

[0021] Figure 14 a-14b respectively show Figure 2 A schematic diagram of the third structure of the central base and a side sectional view of the corresponding locking assembly.

[0022] Figure 15 a-15b shows Figure 14 Side sectional views of the locking wire component in its initial position and locking wire position.

[0023] Figure 16 A cross-sectional schematic diagram of the locking assembly in the second embodiment is shown.

[0024] Figure 17 A three-dimensional schematic diagram of the locking assembly in the second embodiment is shown.

[0025] Figure 18 It shows Figure 17 A three-dimensional sectional view of the central base.

[0026] Figure 19 a-19b shows Figure 17 Three-dimensional schematic diagrams of the center locking component from two different angles.

[0027] Figure 20 It shows Figure 17 A three-dimensional schematic diagram of the middle end cover and drive components.

[0028] Figure 21-22 They are shown respectively Figure 16 A side sectional view of the locking wire component in its initial position and the locking wire position.

[0029] Figure 23 It shows Figure 22 A diagram showing the direction of the center suture's extension.

[0030] Figure 24 Several state diagrams of the locking assembly with different anchoring parts in the first embodiment are shown.

[0031] Figure 25 It shows the ability to Figure 24 A schematic diagram of a locking device that delivers the locking assembly to human tissue.

[0032] Figure 26 It shows the removal Figure 25 The diagram below shows the assembly of the locking assembly and locking device following the conduit.

[0033] Figure 27 It shows Figure 26 A three-dimensional schematic diagram of the release assembly and traction component.

[0034] Figure 28 It shows Figure 26 A side sectional view of the release part of the release rod disengaging from the locking assembly.

[0035] Figure 29 It shows Figure 28 A side sectional view showing the separation of the release assembly and the locking assembly.

[0036] Figure 30 It shows the use of Figure 25 The diagram illustrates how the locking device allows the locking assembly to enter the ventricle of the mitral valve via a catheter pathway.

[0037] Figure 31 It shows Figure 30 A schematic diagram of using a locking device to anchor the locking assembly into the ventricular tissue.

[0038] Figure 32 It shows Figure 31 A schematic diagram showing the completion of the locking assembly in the process.

[0039] Figure 33 A schematic diagram is shown showing the suture cutter being guided along the suture path to the proximal end of the locking assembly to cut the suture.

[0040] Figure 34 The diagram shows the state after the locking assembly has been implanted.

[0041] Figures 35-38 This demonstrates the use of a locking device in the apical path to... Figure 1 The locking assembly shown is delivered to human tissue to complete edge-to-edge repair.

[0042] The following detailed description, in conjunction with the accompanying drawings, will further illustrate the present invention. Detailed Implementation

[0043] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0044] Furthermore, the following descriptions of the embodiments are made with reference to the accompanying illustrations, which illustrate specific embodiments in which the invention can be implemented. Directional terms used in this invention, such as "up," "down," "front," "rear," "left," "right," "inner," "outer," and "side," are merely directional references to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of the invention, and are not intended to indicate or imply that the referred device or element must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the invention.

[0045] It should be noted that, for the purpose of more clearly describing the locking assembly provided by this invention, the limiting terms "proximal" and "distal" used in this specification are conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure; the direction of the rotational axis of an object such as a column or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object such as a column or tube (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction is the direction along the diameter or radius. It is worth noting that the term "end" appearing in terms such as "proximal," "distal," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, end point, or end face, but also includes a portion extending axially and / or radially from the tip, end point, or end face on the element to which the tip, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The conventional terminology used in this specification is for the purpose of describing specific embodiments only and should not be construed as limiting the invention.

[0046] This invention provides a locking assembly that can access the heart valve via the apex or through a catheter to lock one or more sutures to a target location in human tissue, preventing cardiac dysfunction caused by valvular heart disease. This locking assembly is not only simple to manufacture but also provides sufficient locking force, effectively ensuring its locking effect. Therefore, it is beneficial for improving surgical outcomes and promoting the widespread application of locking sutures.

[0047] Figure 1 Shows a cross-sectional schematic view of the locking component 20 in the first embodiment. Among them, the locking component 20 includes a base 21 and a thread locking member 22 that can move relative to the base 21 (such as rotate). A bearing surface 210 is provided on the base 21, and a thread locking surface 220 that can cooperate with the bearing surface 210 is provided on the thread locking member 22. Further, the thread locking member 22 has an initial position and a thread locking position. When the thread locking member 22 is in the initial position, a gap S is formed between the thread locking surface 220 and the bearing surface 210 for one or more sutures 40 to pass through; when the thread locking member 22 is in the thread locking position, the gap S will decrease, thereby being able to compress the suture 40 and make the suture 40 compress and deform to be locked between the thread locking surface 220 and the bearing surface 210. Among them, when the thread locking member 22 is in the thread locking position, the preferred range of the gap S is 1 / 2D < S < 3 / 4D, where D is the diameter of the suture 40; at this time, if the diameter D of the suture 40 is 0.40 mm and the suture 40 is made of ePTFE, the range of the gap S can be 0.10 mm - 0.15 mm to achieve a suitable thread locking force value and avoid the risk that the suture 40 breaks away from the gap S under the beating of the heart; if the suture 40 is made of 2-0PET or 2-0PTFE material that is harder than ePTFE, the range of the gap S can be appropriately increased on the basis of 0.10 mm - 0.15 mm to achieve a suitable thread locking force value. In addition, the thread locking member 22 can be connected to the base 21 by a pivoting method to achieve the rotational connection between the two. In some embodiments, shaft holes are provided on both the base 21 and the thread locking member 22, and a pivoting shaft realizes the pivoting between the two by passing through the shaft holes of the base 21 and the thread locking member 22 respectively. In another embodiment, the base 21 and the thread locking member 22 are pivoted by a method in which one of the components protrudes with a shaft and the other component is provided with a shaft hole.

[0048] Figure 2-15 Shows Figure 1 The structural schematic diagram of the locking component and its various components in the shown embodiment. Please refer to Figure 2-4The base 21 is generally a hollow cylinder with one end closed and the other open. A through groove 211 extending through both ends is formed on the side wall of the base 21 to provide a space or channel for the locking member 22 to rotate and swing. The through groove 211 extends from the open end to the closed end of the base 21. The locking member 22 can move relative to the through groove 211, for example, by passing through the through groove 211 and moving towards the bearing surface 210 to switch from an initial position to a locking position, thus completing the switching between the initial position and the locking position. In some embodiments, the bearing surface 210 is formed at the closed end of the base 21 and faces the through groove 211. To ensure that the locking member 22 can rotate relative to the base 21, two first shaft holes 212 are symmetrically formed on the side wall of the base 21 near the open end for pivoting the locking member 22 via a pivot shaft 50. Two first shaft holes 212 are symmetrically arranged on both sides of the through groove 211, and both first shaft holes 212 and the bearing surface 210 are located on the same side of the axial central axis of the base 21, for example, above the base 21. In some embodiments, the base 21 is also provided with a first thread passage 213 for the thread 40 to enter the gap S through the first thread passage 213. The diameter of the first thread passage 213 is much larger than the diameter of the thread 40, so that the operator can quickly introduce the thread 40 into the first thread passage 213 and further ensure that the thread 40 can move freely in the first thread passage 213. Specifically, the closed end of the base 21 is provided with an extension 214 on the far end side of the bearing surface 210. The extension 214 extends toward the through groove 211 and protrudes from the through groove 211. The first thread passage 213 axially passes through the extension 214, that is, it axially passes through along the axial central axis parallel to the base 21.

[0049] Please see Figure 5 As shown, the locking member 22 is generally rectangular, and the locking surface 220 is at least one end face of the locking member 22 for good mating with the bearing surface 210. Of course, to facilitate rotational connection with the base 21, a through second shaft hole 221 is provided on the locking member 22, wherein the second shaft hole 221 penetrates the side wall of the locking member 22 and is disposed away from the locking surface 220. Thus, as... Figure 2As shown, the pivot shaft 50 can pass through the first shaft hole 212 of the base 21 and the second shaft hole 221 of the locking member 22 to complete the pivot connection between the two. Furthermore, the locking member 22 also has a through second thread passage 222, which allows the thread 40 to enter the gap S from the first thread passage 213 or the second thread passage 222, and then further pass through the second thread passage 222 or the first thread passage 213 to completely pass through the locking assembly 20, thereby completing the threading of the thread 40 at its initial position on the locking member 22. The second thread passage 222 extends through both surfaces connecting the sidewalls of the locking member 22 and is located adjacent to the locking surface 220. Moreover, the diameter of the second thread passage 222 is much larger than the diameter of the thread 40, so that the operator can quickly pass the thread 40 out of the second thread passage 222, and the thread 40 can move freely within the first thread passage 213 and the second thread passage 222. When the locking member 22 is rotatably connected to the base 21 via the pivot shaft 50, the locking surface 220 and the second wire passage 222 will be located on the same side of the pivot shaft 50.

[0050] In some embodiments, the locking assembly 20 further includes a traction member 60 (see [link to traction member]) that provides rotational driving force to the locking member 22. Figure 25 At least one first traction hole 223 is provided on the thread locking member 22 near the second thread passage 222, for the traction member 60, such as a pull rope, to pass through and connect one end of the traction member 60 to the thread locking member 22. By pulling the other end of the traction member 60, the thread locking member 22 can be driven by the traction member 60 and rotate relative to the base 21 around the pivot shaft 50, thereby causing the thread locking surface 220 to rotate toward the bearing surface 210 and press the thread 40. It is understood that, in order to avoid the risk of the thread 40 and the traction member 60 becoming entangled during the locking of the thread 40, the thread locking surface 220 and the first traction hole 223 are respectively located on both sides of the second thread passage 222. Furthermore, in order to ensure that the thread locking member 22 can rotate effectively around the pivot shaft 50, the first traction hole 223 is located between the thread locking surface 220 and the second shaft hole 221. In some embodiments, there are two first traction holes 223, which are arranged side by side on the locking member 22 along the extension direction parallel to the second shaft hole 221. The axial center line of the first traction hole 223 is parallel to the axial center line of the second wire passage 222 and perpendicular to the axial center line of the second shaft hole 221. Thus, the traction member 60 can pass back through the two first traction holes 223 to connect its distal end to the locking member 22. After pulling the proximal end of the traction member 60 to drive the locking member 22 to the locking position and complete the locking, pulling one of the proximal ends of the traction member 60 can remove the traction member 60 from the locking assembly 20.

[0051] Understandably, to further ensure that the base 21 and the suture locking member 22 remain locked after suture locking, thus guaranteeing that the locking assembly 20 can remain in the patient's body for an extended period and maintain its effectiveness, in some embodiments, the base 21 and the suture locking member 22 engage (not shown). For example, the bearing surface 210 engages with the suture locking surface 220; that is, at least a portion of the bearing surface 210 of the base 21 and at least a portion of the suture locking surface 220 of the suture locking member 22 are respectively provided with multiple teeth that can engage with each other. Thus, when the suture locking member 22 is in the suture locking position to lock the suture 40 in the gap S between the suture locking surface 220 and the bearing surface 210, the locking is further maintained by the engagement of the multiple teeth between them. Of course, in other embodiments, the suture locking member 22 engages with another component of the locking assembly 20, such as the end cap 23. At this time, the locking member 22 has multiple circumferential teeth 224 on the outer periphery of its end face opposite to the locking surface 220 to engage with the rack on the end cap 23 (see...). Figure 6 The meshing enables stepped rotation and wire locking. Multiple circumferential teeth 224 are arranged circumferentially around the second shaft hole 221 on the end face of the wire locking member 22, with the wire locking surface 220, the second wire passage 222, and the first traction hole 223 located on the same side of the second shaft hole 221, and the multiple circumferential teeth 224 located on the other side of the second shaft hole 221.

[0052] Please see Figure 6 As shown, the end cap 23 is generally disc-shaped and is used to fix it to the base 21 and close the open end of the base 21. At this time, the end cap 23 is fixedly connected to the end of the base 21 away from the bearing surface 210. The end cap 23 includes a first surface 230a adjacent to the base 21 and a second surface 230b opposite to the first surface 230a and away from the base 21. When the distal end of the traction member 60 is connected to the first traction hole 223 of the locking member 22, in order to ensure that the proximal end of the traction member 60 can pass through the end cap 23 and even out of the human body for operation by the doctor, a second traction hole 231 is provided on the end cap 23. The second traction hole 231 extends from the first surface 230a and through the second surface 230b to form a through hole, so that the proximal end of the traction member 60 can pass through the second traction hole 231 to exit the locking assembly 20. Meanwhile, a rack 232 is also provided on the first surface 230a to engage with multiple circumferential teeth 224 of the locking member 22. This not only ensures the continuous stability of the locking member 22 in the initial position and the locking position, but also further realizes the stepped control of the locking member 22 relative to the base 21. In some embodiments, the second traction hole 231 and the rack 232 are located on opposite sides of the first surface 230a, and the racks 232 are arranged in approximately three groups side by side above the first surface 230a.

[0053] Furthermore, a boss 233 is also provided on the first surface 230a. The boss 233 is located between the second traction hole 231 and the rack 232, and also between the second traction hole 231 and the first traction hole 223. The boss 233 is generally square and includes a third surface 2330a near the rack 232, a fourth surface 2330b opposite to the third surface 2330a, and a fifth surface 2330c connecting the third surface 2330a and the fourth surface 2330b and away from the first surface 230a. Among them, a limiting slope 2331 is formed on the third surface 2330a. The limiting slope 2331 is opposite to the first surface 230a to limit the rotation angle of the locking member 22. That is, when the locking member 22 rotates to the locking position, the locking member 22 can abut against the limiting slope 2331 to limit the locking member 22 from continuing to rotate. Meanwhile, to prevent the traction member 60, such as the pull rope, from deflecting laterally at the boss 233 during the pulling process, thus changing the pulling trajectory and affecting the pulling force applied to the locking member 22, a third traction hole 2332 is also provided on the boss 233. This hole allows the proximal end of the traction member 60 to pass through the third traction hole 2332 and the second traction hole 231 sequentially before exiting the locking assembly 20. At this time, the traction member 60 located between the second traction hole 231 and the first traction hole 223 can be confined within the third traction hole 2332, so that the traction member 60 can better apply the force to the locking member 22. In some embodiments, the third traction hole 2332 is a closed through hole formed by extending from the fifth surface 2330c to the fourth surface 2330b. The inner surface of the third traction hole 2332 can be a curved surface to reduce wear on the thread 40. Of course, in other embodiments, the third traction hole 2332 can be an open structure such as a U-shaped groove formed by recessing inward from the fourth surface 2330b, to limit the problem of easy displacement of the traction member 60 due to movement. It is understood that after the locking assembly 20 completes the locking of the suture 40, the locking assembly 20 needs to remain inside the human body to maintain the long-term locking of the suture 40. Therefore, in order to ensure that the locking assembly 20 can be detachably connected to the interventional device that delivers the locking assembly 20 to the human body, the second surface 230b of the end cap 23 is provided with a release part 234, such as an S-shaped buckle, a diagonal buckle, an external thread protruding from the second surface 230b, or an internal thread formed by recessing inward from the second surface 230b, to achieve a detachable connection with the corresponding interventional device.

[0054] During assembly, such as Figure 1-2As shown, the end cap 23 is aligned and fixed to the open end of the base 21. The fixing method can be welding or adhesive bonding. At this time, the first shaft hole 212 of the base 21 is positioned between the through groove 211 of the base and the boss 233 of the end cap 23. A certain distance is maintained between the closed end of the base 21 and the end cap 23 to facilitate the passage of the traction member 60. Next, the locking member 22 enters through the through groove 211 of the base 21 to align the second shaft hole 221 of the locking member 22 with the first shaft hole 212 of the base 21. The pivot shaft 50 passes through the first shaft hole 212 and the second shaft hole 221 in sequence to complete the pivot connection. Simultaneously, the circumferential teeth 224 of the locking member 22 need to engage with the rack 232 of the end cap 23 to ensure that the locking member 22 remains in the position as shown. Figure 1 In the initial position shown, the locking member 22 is not restricted by the limiting inclined surface 2331 and can rotate towards the bearing surface 210 under the drive of the traction member 60. Of course, in some embodiments, the two ends of the pivot shaft 50 can be fixed to the two first shaft holes 212 of the base 21 by welding or gluing to avoid the risk of the pivot shaft 50 detaching from the base 21 and the locking member 22, which would cause the locking assembly 20 to fail.

[0055] In some embodiments, such as Figure 8-9 As shown, the bearing surface 210 is formed by recessing inward from the closed end of the base 21, with the recessed direction being vertically downward from the through groove 211. The bearing surface 210 includes a first bearing surface 210a extending along a first direction and a second bearing surface 210b extending from the first bearing surface 210a to a second direction, the second direction being at an angle to the first direction. At this time, the closed end of the base 21 has a certain thickness. The first direction is the direction extending inward from the through groove 211 of the base 21, and the second direction is approximately parallel to the axial direction of the base 21 and extends towards the open end of the base 21. Preferably, the angle α between the first direction and the second direction is an acute angle, that is, the angle α between the first bearing surface 210a and the second bearing surface 210b is an acute angle, ranging from 30 degrees to 90 degrees. The present invention preferably uses an angle α = 60 degrees. Meanwhile, the locking surface 220 includes a first locking surface 220a extending along a first direction and a second locking surface 220b extending from the first locking surface 220a to a second direction. The first locking surface 220a can cooperate with the first bearing surface 210a, and the second locking surface 220b can cooperate with the second bearing surface 210b, thereby locking the suture 40 in two different directions to improve the effectiveness of the locking force and reduce the risk of the suture 40 coming off.

[0056] So, when the locking element 22 is in the initial position, as follows: Figure 9As shown in Figure a, one end of the locking thread member 22 is positioned in the gap between the boss 233 and the through groove 211 of the end cap 23, such that the multiple circumferential teeth 224 of the locking thread member 22 engage with the rack 232 of the end cap 23. At this time, the locking thread surface 220 is above the through groove 211, that is, outside the base 21; and there is a gap S between the bearing surface 210 of the base 21 and the locking thread surface 220 of the locking thread member 22. The free end of the thread 40 can enter the gap S from the first thread passage 213 and pass through the second thread passage 222 to pass through the locking assembly 20, thereby realizing the quick threading of the locking assembly 20. At this time, the thread 40 can slide freely in the first thread passage 213 and the second thread passage 222. Next, the traction member 60 drives the thread-locking member 22 to rotate around the pivot shaft 50 toward the bearing surface 210. Multiple circumferential teeth 224 of the thread-locking member 22 are progressively controlled by meshing with the rack 232 of the end cap 23. The thread-locking surface 220 passes through the through groove 211 of the base 21 and pulls the thread 40 toward the bearing surface 210 within the base 21. When the gap S between the thread-locking surface 220 and the bearing surface 210 decreases to the point where the thread 40 is compressed and deformed between them, reaching a suitable thread-locking force, the thread-locking member 22 reaches the thread-locking position, such as... Figure 9 As shown in b. At this time, the suture 40 is locked to the bearing surface 210 by the locking member 22, that is, the suture 40 is pressed between the first bearing surface 210a and the second bearing surface 210b by the first locking surface 220a and the second locking surface 220b to achieve the locking of the suture 40. At the same time, the locking member 22 will be held in the locked position by the engagement of the base 21 or the end cap 23, thereby ensuring the long-term stability of the locking assembly 20.

[0057] In addition, from Figure 9 It can be seen that suture 40 extends in a single direction at the initial position, and its extension direction at the lockstitch position is roughly U-shaped. Please also refer to... Figure 10As shown, the extension direction of the suture 40 at the locking position sequentially includes direction A through the first thread passage 213 extending in a generally horizontal direction, then direction B through the first bearing surface 210a extending in a generally vertical direction, then direction C through the second bearing surface 210b extending in a generally horizontal direction, and finally direction D through the second thread passage 222 extending in a generally vertical direction, thus forming a multi-directional extension and reducing the risk of easy detachment caused by the suture 40 extending in a single direction. In some embodiments, the angle between direction A and direction B is an acute angle, ranging from 30 degrees to 90 degrees, preferably 45 degrees in this invention. It should be noted that the shape of the suture 40 locked by the bearing surface 210 and the locking surface 220 is approximately L-shaped, and the length of the suture 40 locked is the sum of the vertical length of the first locking surface 220a and the lateral length of the second locking surface 220b, thus increasing the effective length of the suture 40 locked, which not only effectively improves the locking force of the locking assembly 20, but also further increases the reliability of the suture 40 locking.

[0058] In other embodiments, such as Figure 11-13 As shown, the bearing surface 210 further includes a third bearing surface 210c extending from the second bearing surface 210b in a third direction, the third direction being angled to the second direction. The angle β between the third direction and the second direction is preferably obtuse, i.e., the angle β between the third bearing surface 210c and the second bearing surface 210b is obtuse, for example, β = 120 degrees. Simultaneously, the locking surface 220 further includes a third locking surface 220c extending from the second locking surface 220b in a third direction. The third locking surface 220c can cooperate with the third bearing surface 210c to lock the suture 40 in three different directions, thereby improving the effectiveness of the locking force and reducing the risk of the suture 40 coming off. Specifically, a protrusion 215 is provided on the side of the second bearing surface 210b away from the first bearing surface 210a, forming a gap between the protrusion 215 and the first bearing surface 210a. The third bearing surface 210c is the surface on the protrusion 215 opposite to the first bearing surface 210a and connected to the second bearing surface 210b. Additionally, the third thread-locking surface 220c is at least a portion of the inner surface of the second thread passage 222 of the thread-locking member 22 and is disposed close to the first thread-locking surface 220a. In some embodiments, the cross-section of the protrusion 215 is smaller than the aperture of the second thread passage 222 of the thread-locking member 22; thus, when the thread-locking member 22 is in the thread-locking position, the protrusion 215 will be received within the second thread passage 222, and the thread 40 will be pressed against the first bearing surface 210a and the second bearing surface 210b by the first thread-locking surface 220a and the second thread-locking surface 220b, and further locked onto the third bearing surface 210c by the third thread-locking surface 220c. At this time, as Figure 13As shown in b, the shape of the suture 40 locked by the bearing surface 210 and the locking surface 220 is roughly U-shaped. The length of the suture 40 locked is the sum of the vertical length of the first locking surface 220a, the horizontal length of the second locking surface 220b, and the vertical length of the third bearing surface 210c. Therefore, the effective length of the suture 40 locked is further increased, so as to further improve the locking force and locking reliability of the locking assembly 20.

[0059] Of course, in other embodiments, such as Figure 14-15 As shown, the bearing surface 210 may only include the first bearing surface 210a, and the locking surface 220 may only include the first locking surface 220a that mates with the first bearing surface 210a. When the locking member 22 is in the locking position, the thread 40 can be pressed into the gap S between the first bearing surface 210a and the second locking surface 220a. The shape of the thread 40 locked by the bearing surface 210 and the locking surface 220 is approximately I-shaped. In some embodiments, the first bearing surface 210a and the first locking surface 220a can be flat, curved, or wavy, to facilitate designers in selecting appropriate surface designs based on considerations such as locking force and ease of manufacturing processes.

[0060] Specifically, such as Figure 14 As shown, to ensure that the suture 40 can be uniformly locked between the first bearing surface 210a and the first locking surface 220a, the first bearing surface 210a and the first locking surface 220a are designed as curved surfaces. Specifically, the base 21 has a central axis X, and the locking member 22 can be rotatably connected to the base 21 around the central axis X. The circumference of the extension direction of the first bearing surface 210a and the circumference of the extension direction of the first locking surface 220a are concentric circles around the central axis X. That is, the first bearing surface 210a and the first locking surface 220a are concentric circles around the central axis X. Therefore, when the locking member 22 rotates from its initial position toward the base 21 to the locking position, the suture 40 can be compressed and deformed and uniformly locked between the first bearing surface 210a and the first locking surface 220a. In other words, at this time, the gap S between all points located between the first bearing surface 210a and the first locking surface 220a is equal and uniform. That is, the locking trajectory of the suture 40 is uniform. At this time, the maximum locking force on the suture 40 will come from any position of the locking trajectory. At this time, the risk of the suture 40 breaking will be greatly reduced, further ensuring the surgical effect.

[0061] It should be specifically noted that in order to ensure that the suture 40 can be compressed, the preferred range of the compression deformation amount L after the suture 40 is locked is 1 / 2D < L < 3 / 4D, where D is the diameter of the suture 40; at this time, if the suture 40 is made of ePTFE material, the range of the compression deformation amount L of the suture 40 can be 0.10 mm - 0.15 mm, so as to achieve an appropriate suture locking force value and avoid the risk that the suture 40 breaks away from the gap S under the beating of the heart; if the suture 40 is made of 2-0 PET or 2-0 PTFE material which is harder than ePTFE, the range of the compression deformation amount L can be appropriately increased on the basis of 0.10 mm - 0.15 mm to achieve an appropriate suture locking force value.

[0062] In some embodiments, as Figure 14 shown, the circumference in the extending direction of the first bearing surface 210a has a first radius R1, and the circumference in the extending direction of the first suture locking surface 220a has a second radius R2, and the first radius R1 is greater than the second radius R2 to provide a gap for the suture 40 to be locked. Further, in order to realize the relative rotation between the suture locking member 22 and the base 21, please refer to Figure 15 shown. Define the centers of the two first shaft holes 212 on the base 21 as the central axis X, that is to say, the central axis X extends along the radial direction of the base 21. At the same time, the base 21 has two first shaft holes 212 opened around the central axis X, and the suture locking member 22 has a second shaft hole 221 opened around the central axis X. The pivot shaft 50 passes through the first shaft hole 212 and the second shaft hole 221 to realize the rotational connection between the two. In addition, as Figure 15 shown in FIG. a, when the suture locking member 22 is in the initial position, the suture 40 passes through the first wire passing channel 213 and the second wire passing channel 222 and will be located between the suture locking surface 220 and the bearing surface 210, so as to ensure that the suture 40 can be driven by the suture locking member 22 and locked between the suture locking surface 220 and the bearing surface 210. In some embodiments, the suture locking surface 220 is located above the second wire passing channel 222, and the bearing surface 210 is located below the first wire passing channel 213. In view of the other structures of the various components of the suture knotting assembly 20 and Figure 8-9 the suture knotting assembly 20 shown are the same, they will not be elaborated here.

[0063] It can be understood that since it is necessary to squeeze and lock the suture 40, the base 21, the suture locking member 22, the end cover 23, and the pivot shaft 50 are designed to be rigidly connected to each other. In addition, as an implant in the body, the suture knotting assembly 20 needs to meet requirements such as biocompatibility and cytotoxicity. Therefore, the base 21, the suture locking member 22, the end cover 23, and the pivot shaft 50 are preferably made of stainless steel 316LVM.

[0064] Figure 16Shows a cross-sectional schematic view of the locking component 30 in the second embodiment. Among them, the locking component 30 includes a base 31 and a thread locking member 32 that can move relative to the base 31 (such as axial movement). A bearing surface 310 is provided on the base 31, and a thread locking surface 320 that can cooperate with the bearing surface 310 is provided on the thread locking member 32. Further, the thread locking member 32 has an initial position and a thread locking position. When the thread locking member 32 is in the initial position, a gap S is formed between the thread locking surface 320 and the bearing surface 310 to allow one or more sewing threads 40 to pass through the gap S; when the thread locking member 32 is in the thread locking position, the gap S will decrease, and thus the sewing thread 40 can be locked between the thread locking surface 320 and the bearing surface 310 to complete the locking of the sewing thread 40. Specifically, the thread locking member 32 is slidably received in the base 31 to achieve a sliding connection between the two. And, the thread locking surface 320 and the bearing surface 310 are oppositely arranged and form a gap S. When the thread locking member 22 is in the thread locking position, the range of the gap S is 1 / 2D < S < 3 / 4D, where D is the diameter of the sewing thread 40.

[0065] Figure 17-23 Shows Figure 16 The structural schematic views of the locking component and its various components in the shown embodiment. Please refer to Figure 17-18 , where the base 31 is generally in the shape of a hollow cylinder with one end closed and the other end open. A through groove 311 that penetrates both ends is provided on the side wall of the base 31 to provide an axial movement track for the thread locking member 32. Among them, the through groove 311 penetrates from the open end of the base 31 to the closed end, and the thread locking member 32 can move relative to the through groove 311, such as axially sliding along the extension channel of the through groove 211 towards the bearing surface 210 to switch from the initial position to the thread locking position, so as to complete the switching of the thread locking member 32 between the initial position and the thread locking position. In some embodiments, the bearing surface 310 is formed at the closed end of the base 31 and faces the through groove 311, so that the thread locking member 32 can cooperate with the bearing surface 310 through the sliding track of the through groove 311. Further, a first thread passing channel 313 is also provided on the base 31 for the sewing thread 40 to enter the gap S from the first thread passing channel 313. Among them, the diameter of the first thread passing channel 313 is much larger than the diameter of the sewing thread 40, so as to facilitate the operator to quickly introduce the sewing thread 40 into the first thread passing channel 313 and further ensure that the sewing thread 40 can move freely in the first thread passing channel 313. Specifically, an extension portion 314 is provided on the distal side of the closed end of the base 31 where the bearing surface 310 is located. The extension portion 314 extends towards the through groove 311 and protrudes from the through groove 311. The first thread passing channel 313 axially penetrates the extension portion 314, that is, axially penetrates along the axial central axis parallel to the base 21.

[0066] Please refer to Figure 19As shown, the thread-locking member 32 is generally disk-shaped, including a sixth surface 321a and a seventh surface 321b opposite to the sixth surface 321a. An extension 3210 extends from at least a portion of the sixth surface 321a in a direction away from the seventh surface 321b. In some embodiments, the extension 3210 is perpendicular to the sixth surface 321a and located above the thread-locking member 32. A thread-locking surface 320 is formed on the extension 3210 and the sixth surface 321a. Furthermore, the thread-locking member 32 also has a through second thread-passing channel 322, which is disposed away from the thread-locking surface 320. This allows the thread 40 to enter the gap S from the first thread-passing channel 313 or the second thread-passing channel 322, and then further pass through the second thread-passing channel 322 or the first thread-passing channel 313 to completely pass through the locking assembly 30, thereby completing the threading of the thread 40 at its initial position on the thread-locking member 32. Specifically, the second thread passage 322 is disposed opposite to the extension 3210. The second thread passage 322 extends from the sixth surface 321a away from the extension 3210 to the seventh surface 321b to form a through hole. In some embodiments, the through hole is perpendicular to the sixth surface 321a and the seventh surface 321b. The diameter of the second thread passage 322 is much larger than the diameter of the thread 40, so that the operator can quickly pass the thread 40 through the second thread passage 322 and allow the thread 40 to move freely within the first thread passage 313 and the second thread passage 322. Of course, in order to ensure that the locking member 32 can slide smoothly and stably relative to the base 31, a slider 323 is provided on the side wall of the locking member 32 for cooperating with the through groove 311 of the base 31. The slider 323 can slide along the trajectory of the through groove 311 to switch the locking member 32 between the initial position and the locking position relative to the base 31. In some embodiments, the slider 323 is formed by extending from the extension 3210 in a direction away from the second wire passage 322, that is, the slider 323 protrudes above the extension 3210. It is understood that, in order to ensure that the wire locking member 32 can be driven by an external force to slide relative to the base 31, the wire locking member 32 further includes a driving surface 324, which is at least a portion of the surface on the seventh surface 321b. In some embodiments, the driving surface 324 is disposed adjacent to and above the second wire passage 322.

[0067] Understandably, to further ensure that the base 31 and the suture locking member 32 remain locked after suture locking, thus guaranteeing that the locking assembly 30 can remain in the patient's body for an extended period and maintain its effectiveness, in some embodiments, the bearing surface 310 of the base 31 and the suture locking surface 320 of the suture locking member 32 engage to prevent the suture 40 from easily coming loose. Of course, in other embodiments, such as... Figure 17As shown, the locking assembly 30 further includes an end cap 33 and a drive member 34. The drive member 34 drives the locking member 32 to slide to the locking position and cooperates with the end cap 33 to keep the locking member 32 in the locked position to prevent the suture 40 from coming loose.

[0068] Specifically, please refer to Figure 20 As shown, the end cap 33 is generally disc-shaped and is fixedly connected, for example, welded to the base 31 to close the open end of the base 31. The end cap 33 has a third thread channel 331 extending through both ends for the thread 40 to pass through. In some embodiments, the third thread channel 331 is a U-shaped through groove formed by an inward indentation from the side wall of the end cap 33, and the inner diameter of the U-shaped through groove 331 is much larger than the diameter of the thread 40, so that the operator can quickly pass the thread 40 through the U-shaped through groove 331, and the thread 40 can move freely within the first thread channel 213, the second thread channel 222, and the U-shaped through groove 331. Furthermore, the approximately central area of ​​the end cap 33 also has an internally threaded channel 331 extending through both ends to thread with the drive assembly 34, thereby ensuring the continuous stability of the locking member 32 in the initial position and the locking position.

[0069] The driving member 34 is generally cylindrical in shape, including a driving surface 341 located near the locking member 32 and an external thread 342 arranged circumferentially around the driving member 34. Specifically, the driving member 34 passes through the internal threaded channel 331 of the end cap 33 and is threadedly connected to the internal threaded channel 331 via the external thread 342. The driving surface 341 is used to abut against the driving surface 324 of the locking member 32. The driving member 34 is spirally pushed distally relative to the end cap 33, and the locking member 32 can slide axially within the base 31 under the spiral push of the driving surface 341. It is understood that, in order to ensure that the locking assembly 30 can be detachably connected to the interventional device that delivers the locking assembly 30 to the human body, the driving member 34 is further provided with a release part 343, such as an S-clasp or a diagonal clasp, to achieve a detachable connection with the corresponding interventional device. In some embodiments, the release part 343 protrudes from the end away from the driving surface 341 to form a hollow S-clasp for removable connection with the interventional device.

[0070] During assembly, such as Figure 17 and 21As shown, the slider 323 of the thread-locking component 32 is placed in the through groove 311 of the base to align and connect the two. Next, the end cap 33 is aligned and fixed to the open end of the base 31, either by welding or by adhesive bonding. At this time, the thread-locking surface 320 of the thread-locking component 32 is positioned opposite to the bearing surface 320 of the base 31 with a gap S, and the first thread-passing channel 322 of the thread-locking component 32 is opposite to the third thread-passing channel 331 of the end cap 33 to facilitate the thread 40 passing through. Finally, the drive component 34 is threaded to the internal threaded channel 332 of the end cap 33, ensuring that the drive surface 324 extends out of the internal threaded channel 332 of the end cap 33 into the base 32, thus ensuring that the thread-locking component 32 is positioned as shown. Figure 21 The initial position is shown; at this time, the locking member 32 is positioned adjacent to the end cap 33, and the driving surface 324 of the locking member 32 is kept in contact with the driving surface 341 of the end cap 33. Thus, the suture 40 can enter the gap S from the first thread passage 313 of the base 31, and further pass through the second thread passage 322 and the third thread passage 331 before exiting the locking assembly 30 to complete the introduction operation of the suture 40.

[0071] In some embodiments, the bearing surface 310 may include, for example, Figure 21 The diagram shows a first bearing surface 310a extending in a first direction, a second bearing surface 310b extending from the first bearing surface 310a in a second direction, and a third bearing surface 310c extending from the second bearing surface 310b in a third direction. The thread-locking surface 320 may include, for example... Figure 22 The diagram shows a first thread-locking surface 320a extending along a first direction, a second thread-locking surface 320b extending from the first thread-locking surface 320a in a second direction, and a third thread-locking surface 320c extending from the second thread-locking surface 320b in a third direction. The first direction and the second direction are set at an acute angle; that is, the angle between the first bearing surface 310a and the second bearing surface 310b is an acute angle, ranging from 30 degrees to 90 degrees, with a preferred angle of 60 degrees. The second direction and the third direction can be set at any angle; that is, the angle between the third bearing surface 310c and the second bearing surface 310b can be any angle, with a preferred angle of 90 degrees. Of course, in other embodiments, the bearing surface 310 may only include the first bearing surface 310a and the second bearing surface 310b to ensure that the suture 40 is approximately L-shaped after locking.

[0072] Therefore, when the locking element 32 is in such a state Figure 21In the initial position shown, the suture 40 can enter from the first thread passage 313 of the base 31, and further pass through the gap between the first bearing surface 310a and the first locking surface 320a, the gap between the second bearing surface 310b and the second locking surface 320b, and the gap between the third bearing surface 310c and the third locking surface 320c. Then, it passes through the second thread passage 322 of the locking thread space 32 and the third thread passage 331 of the end cap 33 before exiting the locking assembly 30. At this time, the suture 40 can slide freely in the gap S. Next, the rotating drive member 34 is rotated to advance axially relative to the end cap 33 and the base 31. When the driving surface 341 is driven by the drive member 34, it drives the locking member 32 to slide towards the bearing surface 310 until... Figure 22 In the lock position shown, the suture 40 is locked to the bearing surface 310 by the locking member 32. That is, the suture 40 is pressed between the first bearing surface 310a, the second bearing surface 320b, and the third bearing surface 320c by the first locking surface 320a, the second bearing surface 320b, and the third bearing surface 310c, thereby locking the suture 40 in three different directions to improve the effectiveness of the locking force and reduce the risk of the suture 40 coming off. When the driving force applied to the drive member 34 is removed, the locking member 32 is restricted by the threaded connection between the end cap 33 and the drive member 34 and can be held in the locked position, thus ensuring the long-term stability of the locking assembly 30.

[0073] Please refer to Figure 23. The extension direction of the suture 40 at the lock-lock position sequentially includes direction A through the first thread passage 313 extending in a generally horizontal direction, then direction B through the first bearing surface 310a extending in a generally vertical direction, then direction C through the second bearing surface 310b extending in a generally horizontal direction and direction E away from direction A through the third bearing surface 310c extending in a vertical direction, and finally direction F through the second thread passage 322 and the third thread passage 331 extending in a generally horizontal direction, thus forming a multi-directional extension, thereby reducing the risk of easy detachment caused by the suture 40 extending in a single direction. In some embodiments, the angle between direction A and direction B is an acute angle, ranging from 30 degrees to 90 degrees, and preferably 45 degrees in this invention. It should be noted that the locked shape of the suture 40 is roughly inverted Z-shape. The locked length of the suture 40 is the sum of the vertical length of the first locking surface 320a, the horizontal length of the second locking surface 320b, and the vertical length of the third locking surface 320c. Therefore, the effective length of the locked suture 40 is guaranteed, thereby improving the locking force and the reliability of the locking.

[0074] It should be noted that the locking assembly 20 provided by the present invention achieves locking of the suture 40 through the relative movement between the base 21 and the locking element 22. Since both the base 21 and the locking element 22 are individually machined components, the present invention can ensure a suitable locking gap S or the compression deformation L of the suture by controlling the assembly dimensions between the two components. Therefore, compared with the prior art locking devices using compression locking pins, the present invention is not only easier to manufacture but also ensures sufficient locking force, thereby effectively guaranteeing the locking effect of the locking assembly 20 and facilitating its promotion and application.

[0075] In some embodiments, such as Figure 24 As shown, the locking assembly 20 may further include an anchoring portion extending distally from the base 21, such as an anchoring portion 25 extending axially distally from the closed end of the base 21. The anchoring portion 25 may be a helical coil, capable of being helically advanced distally to anchor into the tissue; the anchoring portion 25 may also be a radially expandable implant, capable of being axially advanced distally to anchor into the tissue. Once the anchoring portion 25 is anchored into the human tissue, the suture 40 is adjusted to an appropriate tension to achieve optimal valve function, and the locking element 22 further secures the suture 40 to this appropriate tension position. The locking assembly 20 with the anchoring portion can be applied not only to artificial chordae tendineae implantation but also to annular and ventricular reconstruction procedures to fix the suture 40 into the heart tissue to repair heart function.

[0076] like Figure 25-29 As shown, the locking assembly 20 / 30 of the present invention can be delivered to a target location inside the patient's body by an interventional device, such as a locking device, and lock the suture 40. The following description uses the locking assembly 20 as an example, wherein the locking device 200 includes a catheter 10, a release assembly 70, and a handle (not shown). The catheter 10 is a hollow, flexible, slender tube, such as a flexible sheath, a cut metal tube, or a flexible tube made of other materials. The locking assembly 20 is pre-loaded onto the distal end of the catheter 10. The distal end of the traction member 60 wraps around to the two first traction holes 223 of the locking member 22. The proximal end of the traction member 60 passes sequentially through the third traction hole 2332 and the second traction hole 231 of the end cap 23, and further penetrates the catheter 10 to the proximal handle for fixed connection to the handle. Wherein, as Figure 27 As shown, the traction member 60 has a certain degree of flexibility, such as polymer suture, nickel-titanium wire, stainless steel braided rope, etc. The present invention preferably uses polymer PE suture, which has a smoother surface and a smaller bending radius than metal wire, so that the resistance when the traction member 60 is released from the locking member 22 is relatively smaller.

[0077] In some embodiments, the release assembly 70 is detachably connected to the release portion 234 of the locking assembly 20. For example... Figure 27 As shown, the release assembly 70 includes a support member 71 and a release rod 72. The support member 71 is a hollow tube of a certain length. An S-shaped buckle is provided at the distal end of the support member 71, which engages with the release portion 234 of the end cap 23. The proximal end of the support member 71 passes through the guide tube 10 and is fixed to the handle. The release rod 72 is generally elongated and is placed within the hollow cavity of the support member 71, and can be pulled and slid relative to the support member 71. Please refer to [link / reference]. Figure 25 As shown, the support 71 connects the release lever 72 within the release portion 234 of the locking assembly 20. Both the locking assembly 20 and the release assembly 70 are pre-loaded into the catheter 10 after connection. When the proximal handle is operated to drive the release assembly 70 distally, for example, by spiraling, so that the anchoring portion 25 extends out of the catheter 10 and anchors into the human tissue, the traction member 60 is pulled to drive the locking member 22 to complete the locking. Then, the operator will further operate the proximal handle as follows... Figure 28 The release lever 72 is disengaged from the release portion 234 of the end cap 23 in the manner shown to achieve separation of the two. The state after separation is as follows: Figure 29 As shown. It can be understood that the material of the support member 71 can be stainless steel cut tube, stainless steel wound tube, nickel-titanium cut tube, polymer tube, etc., and the present invention preferably uses stainless steel wound tube; the material of the release rod 72 can be stainless steel rod, nickel-titanium rod or polymer rod. Since polymer rod is easy to break under stress and stainless steel rod is difficult to recover after deformation, the present invention preferably uses nickel-titanium rod.

[0078] The following example, using artificial chordae tendineae implantation, illustrates how the locking device 200, via a transcatheter approach, delivers and anchors the locking assembly 20, with its anchoring portion 25, to the ventricular tissue of the mitral valve, such as the papillary muscle or free wall, to complete the artificial chordae tendineae implantation of the mitral valve and thus prevent mitral regurgitation. Specifically, the locking assembly 20 is pre-loaded at the distal end of the locking device 200. After the transcatheter leaflet suturing operation is completed, the free end of the suture 40 is led out and further introduced into the locking assembly 20 of the locking device 200. Then, maintaining moderate tension on the suture 40, the locking device 200 is advanced at a constant speed along the direction of the suture 40 into the ventricular region of the mitral valve, approaching and abutting the target anchoring area of ​​the papillary muscle, such as... Figure 30 As shown. After attachment, as... Figure 31 As shown, the proximal handle is operated to push the anchoring portion 25 of the locking assembly 20 out of the distal end of the catheter 10, thereby anchoring the anchoring portion 25 to the papillary muscle to complete the anchoring operation. The anchoring portion 25 can be inserted in a direction approximately perpendicular to the papillary muscle. Next, after adjusting the suture 40 to the appropriate tension, the traction member 60 is pulled to cause the locking member 22 to compress and lock the suture 40, thus completing the locking operation. Then, the release lever 72 is withdrawn to release the locking assembly 20 from the locking device 200 and remove it from the locking device 200. The state after withdrawal is as follows... Figure 32As shown. Finally, the suture cutter 80 is introduced externally along the path of the suture 40 to the proximal end of the locking assembly 20, and a suture cutting operation is performed on the suture 40 at the proximal end of the locking assembly 20, as shown. Figure 33 As shown. After the tangling is completed, the tangent 80 is withdrawn, and the implantation state of the locking assembly 20 is as follows. Figure 34 As shown, at this point, the suture 40, after being cut, will be formed between the leaflet of the heart valve and the ventricular tissue to form an artificial chordae tendineae, thereby replacing or supplementing the natural chordae tendineae inside the heart.

[0079] Of course, if the locking assembly 20 does not include the anchoring portion 25, then the locking assembly 20 and its corresponding locking device 200 can be applied to edge-to-edge repair surgeries, which only require locking sutures. The following example of edge-to-edge repair illustrates how the locking device 200 completes edge-to-edge mitral valve repair via a transapical approach. Specifically, after completing the transapical leaflet suturing operation, the free end of the suture 40 is led out of the body for insertion into the locking assembly 20 of the locking device 200, such as... Figure 35 As shown, at this time, the locking assembly 20 has been pre-loaded onto the distal end of the locking device 200. After the locking device 200 is advanced at a constant speed along the direction of the suture 40 to the target position of the mitral valve leaflet, the locking assembly 20 is pushed out of the distal end of the catheter 10, as shown. Figure 36 As shown. Adjust the suture 40 to the appropriate tension and drive the locking assembly 20 to lock the suture to ensure that the suture 40 is maintained under the appropriate tension, and then introduce as shown. Figure 37 The suture cutter 80 is shown cutting the suture 40 to the proximal end of the locking assembly 20. The state after suture cutting is as follows: Figure 38 As shown.

[0080] The above describes the embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the embodiments of the present invention, and these improvements and modifications are also considered within the scope of protection of the present invention.

Claims

1. A locking assembly, characterized in that, The locking assembly includes a base and a locking thread member movable relative to the base. The base has a bearing surface and a first thread passage. The locking thread member has a locking thread surface that mates with the bearing surface and a second thread passage. The locking thread member has an initial position and a locking thread position. In the initial position, a gap is formed between the locking thread surface and the bearing surface, and the thread passes through the first thread passage, the gap, and the second thread passage. In the locking thread position, the gap is reduced to lock the thread between the locking thread surface and the bearing surface. The bearing surface includes a first bearing surface extending along a first direction and a second bearing surface extending from the first bearing surface in a second direction. The locking thread surface includes a first locking thread surface extending along the first direction and a second locking thread surface extending from the first locking thread surface in the second direction. The second direction is angled to the first direction.

2. The locking assembly as described in claim 1, characterized in that, The angle between the first bearing surface and the second bearing surface ranges from 30 degrees to 90 degrees.

3. The locking assembly as described in claim 1, characterized in that, The bearing surface further includes a third bearing surface extending from the second bearing surface in a third direction, and the locking surface further includes a third locking surface extending from the second locking surface in the third direction, wherein the third direction is set at an angle to the second direction.

4. The locking assembly as claimed in claim 1, characterized in that, At the locking position, the range of the gap is: D is the diameter of the suture, and S is the gap.

5. The locking assembly as claimed in claim 1, characterized in that, A through groove extending through both ends is formed on the side wall of the base, the bearing surface is positioned facing the through groove, and the locking member moves relative to the through groove to switch between the initial position and the locking position.

6. The locking assembly as claimed in claim 1, characterized in that, The locking element is rotatably connected to the base, and the locking assembly also includes an end cap, which is fixedly connected to one end of the base away from the bearing surface, and the locking element engages with the end cap.

7. The locking assembly as claimed in claim 6, characterized in that, The locking wire member has a plurality of circumferential teeth on its end face opposite to the locking wire surface, and the end cover has a rack that meshes with the plurality of circumferential teeth on its surface adjacent to the base.

8. The locking assembly as claimed in claim 6, characterized in that, The locking assembly also includes a traction member, and the locking member has a first traction hole. The distal end of the traction member passes through and is connected to the first traction hole. The locking surface and the first traction hole are located on both sides of the second wire passage.

9. The locking assembly as claimed in claim 8, characterized in that, The locking element is rotatably connected to the base via a pivot shaft, and the locking surface, the second wire passage, and the first traction hole are located on the same side of the pivot shaft.

10. The locking assembly as claimed in claim 8, characterized in that, The end cap includes an axially extending second traction hole for the proximal end of the traction member to pass through the second traction hole from the locking assembly.

11. The locking assembly as claimed in claim 10, characterized in that, The end cap has a protrusion on its surface adjacent to the base. The protrusion is located between the second traction hole and the first traction hole. A third traction hole is provided on the protrusion. The proximal end of the traction member passes through the third traction hole and the second traction hole in sequence and then exits the locking assembly.

12. The locking assembly as claimed in claim 11, characterized in that, A limiting inclined surface is also provided on the boss, and the locking wire component abuts against the limiting inclined surface after rotating to the locking wire position.

13. The locking assembly as claimed in claim 1, characterized in that, The locking element is slidably housed within the base, the locking surface is disposed opposite to the bearing surface and forms the gap, and the second wire passage is disposed away from the locking surface.

14. The locking assembly as claimed in claim 13, characterized in that, A through groove extending through both ends is provided on the side wall of the base, and a slider is protruding on the locking member. The slider slides along the through groove so that the locking member relative to the base switches between the initial position and the locking position.

15. The locking assembly as claimed in claim 13, characterized in that, The locking assembly further includes a driving member, and the locking member further includes a driving surface, which is disposed adjacent to the second wire passage. The driving member engages with the driving surface and drives the locking member to slide within the base.

16. The locking assembly as claimed in claim 15, characterized in that, The locking assembly further includes an end cap, which is fixedly connected to one end of the base away from the bearing surface. The end cap has an axially penetrating internal thread channel, and the driving member has an external thread that mates with the internal thread channel. The driving member is spirally pushed toward the distal end relative to the end cap to drive the locking member to slide axially within the base.

17. The locking assembly as claimed in claim 16, characterized in that, The end cap has a third thread passage opposite to the second thread passage, and the stitch also passes through the third thread passage to exit the locking assembly.

18. The locking assembly as claimed in claim 1, characterized in that, The bearing surface and the locking surface are engaged.

19. The locking assembly as claimed in claim 1, characterized in that, The locking assembly also includes an anchoring portion extending distal to the locking assembly, the anchoring portion being capable of being advanced distally to anchor into the tissue.

20. A locking assembly, characterized in that, The locking assembly includes a base and a locking thread member. The locking thread member is rotatably connected to the base about the central axis of the base, which extends radially along the base. The base has a bearing surface and a first thread passage. The locking thread member has a locking surface and a second thread passage. The thread passes through the first and second thread passages and is located between the locking surface and the bearing surface. The bearing surface includes a first bearing surface extending in a first direction and a second bearing surface extending from the first bearing surface in a second direction. The locking surface includes a first locking surface extending in the first direction and a second locking surface extending from the first locking surface in the second direction. The second direction is at an angle to the first direction. The circumference of the first bearing surface and the circumference of the first locking surface are concentric circles about the central axis. The locking thread member rotates toward the base to uniformly compress and deform the thread between the first locking surface and the first bearing surface.

21. The locking assembly as claimed in claim 20, characterized in that, The circumference of the extension direction of the first bearing surface has a first radius, and the circumference of the extension direction of the first locking surface has a second radius, wherein the first radius is greater than the second radius.

22. The locking assembly as claimed in claim 20, characterized in that, The range of the compression deformation L of the suture is: D is the diameter of the suture.

23. The locking assembly as claimed in claim 20, characterized in that, The base has a first shaft hole around the central axis, the locking member has a second shaft hole around the central axis, and a pivot shaft passes through and connects to the first shaft hole and the second shaft hole.

24. The locking assembly as claimed in claim 20, characterized in that, The locking surface is located above the second wire passage, and the bearing surface is located below the first wire passage.

25. The locking assembly as claimed in claim 20, characterized in that, A through groove extending through both ends is formed on the side wall of the base, and the bearing surface is positioned facing the through groove. The locking member rotates relative to the base to drive the locking surface through the through groove toward the bearing surface.

26. The locking assembly as claimed in claim 20, characterized in that, The locking assembly also includes an end cap, which is fixedly connected to one end of the base away from the bearing surface, and the locking wire engages with the end cap.

27. The locking assembly as claimed in claim 26, characterized in that, The locking wire member has a plurality of circumferential teeth on its end face opposite to the locking wire surface, and the end cover has a rack that meshes with the plurality of circumferential teeth on its surface adjacent to the base.

28. The locking assembly as claimed in claim 26, characterized in that, The locking assembly further includes a traction member, a first traction hole is provided on the locking wire member, a second traction hole is provided on the end cap, the distal end of the traction member passes through and is connected to the first traction hole, and the proximal end of the traction member passes through the second traction hole out of the locking assembly.

29. The locking assembly as claimed in claim 28, characterized in that, The end cap has a protrusion on its surface adjacent to the base. The protrusion is located between the second traction hole and the first traction hole. A third traction hole is provided on the protrusion. The proximal end of the traction member passes through the third traction hole and the second traction hole in sequence and then exits the locking assembly.

30. The locking assembly as claimed in claim 20, characterized in that, The locking assembly also includes an anchoring portion extending distal to the locking assembly, the anchoring portion being capable of being advanced distally to anchor into the tissue.

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