Anchor assembly

Abstract

The present application provides an anchor assembly, including an anchor and a locking wire assembly, the anchor is used to engage the target tissue, the locking wire assembly includes a main body, a wire pressing member and a retaining member, the main body is connected to the proximal end of the anchor, the wire pressing member is movably connected to the main body, the suture is passed between the main body and the wire pressing member, the wire pressing member can be actuated to move relative to the main body and squeeze the suture, the retaining member is located between the main body and the wire pressing member, and the retaining member is configured to keep the wire pressing member in a position to squeeze the suture. When the anchor assembly is used to lock the suture, the operator can first pass the suture between the main body and the wire pressing member, and then anchor the anchor assembly to the target tissue through the anchor, and then actuate the wire pressing member to move relative to the main body to press the suture onto the main body, and use the retaining member to keep the wire pressing member in a position to squeeze the suture, thereby maintaining the stability and effectiveness of the anchor assembly anchoring.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an anchor assembly. Background Art

[0002] Mitral regurgitation (MR), as one of the most common valvular diseases, seriously threatens the patient's life. The mitral valve is a one-way valve connecting the left atrium and the left ventricle, including structures such as the valve ring, valve leaflets, chordae tendineae, and papillary muscles. When the heart relaxes, the valve leaflets open and blood flows from the atrium to the ventricle. When the heart contracts and blood wants to flow from the ventricle to the aorta, the valve leaflets are completely closed under the traction of the chordae tendineae, preventing blood from flowing back from the ventricle to the atrium. However, when one or more structures of the mitral valve are diseased and the valve leaflets cannot completely close when the heart contracts, some blood will flow back into the atrium, causing mitral regurgitation.

[0003] For example, to address the problem of incomplete mitral valve coaptation caused by chordae tendineae disease or rupture, existing technologies typically employ artificial chordae tendineae implantation to secure one end of a suture to the mitral valve leaflets and utilize a locking assembly to anchor the other end of the suture to the ventricular tissue to form an artificial chordae tendineae, thereby replacing the native chordae tendineae structure of the mitral valve. However, the locking assembly in existing technologies does not provide a continuous and reliable self-locking structure to withstand continuous heartbeats, which results in the locking assembly being unable to maintain the locking position for a long time. In severe cases, this may lead to the risk of locking failure. In other words, the stability and effectiveness of the locking assembly's locking line face significant challenges. Summary of the Invention

[0004] The purpose of the present application is to provide an anchor assembly with a self-locking function to ensure that the suture attached to the anchor assembly is locked in the locking position for a long time under continuous heart beating, thereby maintaining the stability and effectiveness of the anchor assembly anchoring.

[0005] In a first aspect, the present application provides an anchor assembly for anchoring a suture on a target tissue, comprising:

[0006] an anchor for engaging the target tissue; and

[0007] A wire locking assembly, comprising:

[0008] a main body member connected to the proximal end of the anchor member;

[0009] a thread pressing member movably connected to the main body, the suture being passed through the main body and the thread pressing member, and the thread pressing member being actuated to move relative to the main body and press the suture; and

[0010] A retaining member is located between the main body and the thread pressing member, and the retaining member is configured to keep the thread pressing member in a position to squeeze the suture.

[0011] When the anchor assembly provided in the present application is used for anchoring sutures, the operator can first pass the suture between the main body and the wire pressing piece in the initial state, and then anchor the anchor assembly to the target tissue through the anchor piece, and then actuate the wire pressing piece to move relative to the main body to the locking state to press the suture to the main body, and use the retaining piece to keep the wire pressing piece in the position of squeezing the suture, that is, keep it in the locking state of the wire pressing piece, so as to resist the risk of suture loosening due to continuous heart beating, help maintain the stability and effectiveness of the anchoring of the anchor assembly, and further maintain the therapeutic effect of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0013] Figure 1 This is a schematic diagram of the three-dimensional structure of an anchor assembly provided in an embodiment of the present application;

[0014] Figure 2 1 is a schematic cross-sectional structural diagram of a wire pressing member in an anchor assembly provided by an embodiment of the present application in an initial state;

[0015] Figure 3 This is a schematic cross-sectional structural diagram of a wire pressing member in an anchor assembly provided by an embodiment of the present application in a wire locking state;

[0016] Figure 4 yes Figure 2 A partial cross-sectional structure enlarged schematic diagram;

[0017] Figure 5 yes Figure 3 A partial cross-sectional structure enlarged schematic diagram;

[0018] Figure 6 This is a schematic diagram of the three-dimensional structure of a wire pressing member provided in an embodiment of the present application;

[0019] Figure 7 This is a schematic diagram of the cross-sectional structure of a wire crimping member provided in an embodiment of the present application;

[0020] Figure 8 This is a schematic diagram of the three-dimensional structure of a main body provided in an embodiment of the present application;

[0021] Figure 9 This is a schematic diagram of the cross-sectional structure of a main body provided in an embodiment of the present application;

[0022] Figure 10 This is a schematic cross-sectional structure diagram of a wire pressing member and a main body member pressed together, provided by an embodiment of the present application;

[0023] Figure 11 This is a schematic diagram of the three-dimensional structure of a retaining member provided in an embodiment of the present application;

[0024] Figure 12 1 is a schematic top view of the structure of an anchor assembly provided in an embodiment of the present application;

[0025] Figure 13 This is a schematic diagram of a structure in which a main body and a retaining member abut against each other, provided by an embodiment of the present application;

[0026] Figure 14 This is a schematic diagram of the structure of an elastic member provided in an embodiment of the present application;

[0027] Figure 15 1 is a schematic diagram of the cross-sectional structure of an anchor assembly when a retaining member is a spring, provided in an embodiment of the present application;

[0028] Figure 16 1 is a schematic diagram of the cross-sectional structure of an anchor assembly when a guide column provided by an embodiment of the present application is an elastic member;

[0029] Figure 17 This is a schematic structural diagram of an anchoring member and a locking wire assembly provided in an embodiment of the present application;

[0030] Figure 18 1 is a schematic structural diagram of an anchor assembly including a buffer provided in an embodiment of the present application;

[0031] Figure 19-20 This is a schematic structural diagram of a conveying device provided in an embodiment of the present application;

[0032] Figure 21 This is a schematic structural diagram of a delivery device and an anchor assembly provided in an embodiment of the present application;

[0033] Figure 22 This is a schematic diagram of the structure of the driving part of the actuator connected to the wire pressing member provided in the embodiment of the present application. Figure 1 ;

[0034] Figure 23 This is a schematic diagram of the structure of the driving part of the actuator connected to the wire pressing member provided in the embodiment of the present application. Figure 2 ;

[0035] Figure 24This is a schematic diagram of the connection between a driver and an anchor provided in an embodiment of the present application;

[0036] Figure 25 This is a schematic diagram of the release of a driver and an anchor provided in an embodiment of the present application;

[0037] Figure 26 This is a schematic diagram of the structure of a driver provided in an embodiment of the present application;

[0038] Figure 27 This is a schematic structural diagram of a driver including a cutting hose provided in an embodiment of the present application;

[0039] Figure 28 is a schematic diagram of a pipe assembly provided in an embodiment of the present application;

[0040] Figure 29 This is a schematic structural diagram of an anchor assembly and a sleeve provided in an embodiment of the present application;

[0041] Figure 30 This is a schematic diagram of the completion of leaflet suturing during artificial chordal implantation provided in an embodiment of the present application;

[0042] Figure 31 This is a schematic diagram of an anchor assembly entering the heart along a suture when a delivery device provided by an embodiment of the present application is used in artificial chordal implantation;

[0043] Figure 32 This is a schematic diagram of the structure of a positioning needle inserted into a target tissue provided by an embodiment of the present application;

[0044] Figure 33 This is a schematic diagram of the structure of an anchor assembly anchoring a target tissue provided by an embodiment of the present application;

[0045] Figure 34 This is a schematic structural diagram of a suture tensioning method provided by an embodiment of the present application;

[0046] Figure 35 This is a schematic structural diagram of an actuator actuating a wire pressing member to lock provided by an embodiment of the present application;

[0047] Figure 36 This is a schematic structural diagram of an actuator being released from an anchor assembly provided by an embodiment of the present application;

[0048] Figure 37 This is a schematic structural diagram of a driver being released from an anchor assembly provided by an embodiment of the present application;

[0049] Figure 38 This is a structural schematic diagram of a conveying device withdrawn according to an embodiment of the present application;

[0050] Figure 39 This is a schematic structural diagram of a tangent device provided in an embodiment of the present application;

[0051] Figure 40 This is a schematic diagram of the completed state of the artificial chordae tendineae implanted according to the embodiment of the present application.

[0052] Description of labels:

[0053] Anchor assembly 1, suture 2, anchor 10, spiral coil 11, connector 12, thread lock assembly 20, main body 21, guide surface 211, main body 212, end plate 213, support portion 214, second thread passage 215, guide portion 216, positioning end 2161, protrusion 217, accommodating channel 218, guide hole 219, thread pressing member 22, self-locking section 221, rotating portion 222, drive portion 223, thread pressing portion 224 , the first wire-passing channel-225, the retaining member-23, the self-locking slope-231, the push member-232, the elastic member-233, the guide column-234, the connecting shaft-24, the buffer member-30, the actuator-40, the driver-50, the drive shaft-51, the flexible section-511, the main section-512, the release rod-52, the positioning needle-60, the tube body assembly-70, the sleeve-71, the U-shaped groove-711, the flexible tube body-72, the delivery sheath-81, the handle assembly-82, and the tangent device-83. DETAILED DESCRIPTION

[0054] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0055] References herein to "embodiments" or "implementations" mean that a particular feature, structure, or characteristic described in connection with the embodiments or implementations may be included in at least one embodiment of the present application. The appearance of such phrases in various places in the specification does not necessarily refer to the same embodiment, nor do they constitute independent or alternative embodiments that are mutually exclusive of other embodiments. It is understood, both explicitly and implicitly, by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0056] It should be noted that the terms "first," "second," and so on in the specification, claims, and drawings of this application are used to distinguish different objects, rather than to describe a specific order. Furthermore, the terms "including," "having," and any variations thereof are intended to cover non-exclusive inclusions.

[0057] In this specification, for convenience, words and phrases indicating orientation or positional relationships, such as "middle," "upper," "lower," "front," "back," "vertical," "horizontal," "top," "bottom," "inside," and "outside," are used to illustrate the positional relationships of constituent elements with reference to the accompanying drawings. This is merely for the purpose of facilitating the description of this specification and simplifying the description, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present disclosure. The positional relationships of constituent elements may be appropriately changed depending on the orientation of the constituent elements being described. Therefore, the present disclosure is not limited to the words and phrases described in the specification and may be appropriately replaced depending on the circumstances.

[0058] In this specification, unless otherwise specified or limited, the terms "mounted," "connected," and "connected" should be interpreted broadly. For example, they can refer to fixed, removable, or integral connections; mechanical or electrical connections; direct connections, indirect connections through intermediaries, or internal communication between two components. Those skilled in the art will understand the meaning of these terms in this disclosure based on the specific circumstances.

[0059] Please refer to Figures 1 to 3 The present application provides an anchor assembly 1 with a self-locking function, which is used to ensure that the suture 2 attached to the anchor assembly 1 is locked in the locking position for a long time under continuous heart beating, thereby maintaining the stability and effectiveness of the anchoring of the anchor assembly 1. The anchor assembly 1 includes an anchor 10 and a locking wire assembly 20. The anchor 10 is used to engage the target tissue, and the locking wire assembly 20 is used to attach the suture 2 and lock the suture 2, so that the anchor assembly 1 anchors the suture 2 to the target tissue through the anchor 10 and the locking wire assembly 20.

[0060] Specifically, the thread locking assembly 20 includes a main body 21, a thread pressing member 22, and a retaining member 23. The main body 21 is connected to the proximal end of the anchor member 10, wherein the proximal end of the anchor member 10 can be fixedly connected to the main body 21 or rotatably connected to the main body 21. The thread pressing member 22 is movably connected to the main body 21, and the suture 2 is passed between the main body 21 and the thread pressing member 22. The thread pressing member 22 can be actuated to move relative to the main body 21 and squeeze the suture 2. For example, the thread pressing member 22 can be moved by the actuator 40 (not limited to Figure 22 and Figure 23The main body 21 is rotated or axially moved under the actuation of the flexible traction member or rigid connecting rod shown in the figure, so that the suture 2 between the main body 21 and the thread pressing member 22 is pressed onto the main body 21. The retaining member 23 is located between the main body 21 and the thread pressing member 22, and the retaining member 23 is configured to keep the thread pressing member 22 in the position of squeezing the suture 2. Specifically, the retaining member 23 is abutted between the main body 21 and the thread pressing member 22 and can be displaced under the drive of the thread pressing member 22, such as elastically displaced under the action of elastic force until it abuts and supports the thread pressing member 22, so that the thread pressing member 22 can continue to squeeze the suture 2, and then the suture 2 is kept in a locked state. Of course, the retaining member 23 can also be displaced between the main body 21 and the thread pressing member 22 under the action of pulling force, thrust, etc.

[0061] When the anchor assembly 1 provided in the present application is used for anchoring the suture 2, the operator can first pass the suture 2 between the main body 21 and the wire pressing piece 22 in the initial state, and then anchor the anchor assembly 1 to the target tissue through the anchor piece 10, and then actuate the wire pressing piece 22 to move relative to the main body 21 to the locking state to press the suture 2 onto the main body 21, and use the retaining piece 23 to keep the wire pressing piece 22 in the position of squeezing the suture 2, that is, keep it in the locking state of the wire pressing piece 22, so as to resist the risk of the suture 2 loosening due to continuous heart beating, and help maintain the stability and effectiveness of the anchoring of the anchor assembly 1, so as to further maintain the therapeutic effect of the operation.

[0062] Please refer to Figure 4 and Figure 5 In one embodiment of the present application, the thread pressing member 22 is rotatably connected to the main body 21, and the rotation axis of the thread pressing member 22 is fixed relative to the position of the main body 21. The end of the thread pressing member 22 close to the suture 2 can rotate relative to the main body 21 in a direction away from the retaining member 23, thereby driving the suture 2 located between the main body 21 and the thread pressing member 22 to move together until it is pressed against the main body 21, so that the suture 2 can be in a locked state. Furthermore, the main body 21 has a guide surface 211, and the retaining member 23 is slidably arranged on the guide surface 211. The thread pressing member 22 has a self-locking section 221 (i.e., the arc-shaped outer surface of the middle end of the thread pressing member 22 that is rotatably connected to the main body 21). In the initial state, as Figure 4 As shown, the self-locking section 221 can be isolated by the retaining member 23 to form a gap S with the guide slide surface 211. The gap S is the distance between the abutting position (such as the first end position A) of the self-locking section 221 abutting the retaining member 23 and the guide slide surface 211, and the gap S can be used to accommodate the retaining member 23. Therefore, when the wire pressing member 22 is actuated to rotate relative to the main member 21 in a direction away from the retaining member 23, the self-locking section 221 can be driven to rotate relative to the main member 21 so that the gap S increases to Figure 5The gap S shown is used to drive or release the retaining member 23 to slide on the guide surface 211 toward the wire pressing member 22, such as to cause elastic displacement on the guide surface 211. At this time, the gap S is the distance from the abutting position (such as the second end position B) on the locking section 221 where the retaining member 23 abuts to the guide surface 211.

[0063] In contrast, the retaining member 23 has a self-locking inclined surface 231 (i.e., the inclined surface of the retaining member 23 facing and abutting against the wire pressing member 22) that cooperates with the self-locking section 221, and the self-locking inclined surface 231 is inclined from the guide surface 211 in a direction away from the wire pressing member 22. The retaining member 23 is elastic and is at least partially compressed between the main body 21 and the wire pressing member 22 to provide elastic thrust, so that the self-locking inclined surface 231 of the retaining member 23 is always in abutment with the self-locking section 221 of the wire pressing member 22, and the self-locking section 221 abuts against different positions of the self-locking inclined surface 231 when the wire pressing member 22 is in different states. Specifically, Figure 4 As shown, the wire pressing member 22 is in the initial state, and the self-locking section 221 abuts against the first position C of the self-locking inclined surface 231; Figure 5 As shown, the wire pressing member 22 is in the wire locking state, and the self-locking section 221 abuts against the second position D of the self-locking inclined surface 231. The elastic displacement of the retaining member 23 causes the self-locking section 221 to move from the first position C of the self-locking inclined surface 231 to the second position D of the self-locking inclined surface 231, wherein the distance from the first position C to the guide sliding surface 211 is smaller than the distance from the second position D to the guide sliding surface 211, thereby increasing the gap S. It is understandable that, please refer to Figure 4 and Figure 5 When the self-locking section 221 abuts against the self-locking inclined surface 231 at the first position C, the self-locking inclined surface 231 abuts against the first end position A of the self-locking section 221. When the self-locking section 221 abuts against the self-locking inclined surface 231 at the second position D, the self-locking inclined surface 231 abuts against the second end position B of the self-locking section 221. The curvature radius R1 of the self-locking section 221 at the first end position A is greater than the curvature radius R2 at the second end position B.

[0064] In one embodiment of the present application, the self-locking segment 221 is a curved surface with a gradually decreasing radius of curvature. Furthermore, the self-locking segment 221 is an arc-shaped outer surface with a gradually decreasing radius of curvature from the first end A to the second end B. The contour line of the self-locking segment 221 can be a section of an Archimedean spiral or a section of an involute. Therefore, when the wire pressing member 22 rotates relative to the main body 21 under the actuation of the actuator 40, the wire pressing member 22 in the initial state can be actuated to rotate relative to the main body 21 in the direction away from the self-locking inclined surface 231, thereby forcing the gap S between the self-locking section 221 and the guide sliding surface 211 to continuously increase. The increase in the gap S causes the first end position A of the self-locking section 221 to disengage from the abutment of the first position C of the self-locking inclined surface 231; under the action of the elastic restoring force, the retaining member 23 moves on the guide sliding surface 211 of the main body 21 until the second position D of the self-locking inclined surface 231 abuts and remains at the second end position B of the self-locking section 221. At this time, the wire pressing member 22 switches from the initial state to the wire locking state. In this way, when the heart beats and drives the suture 2 to react on the thread pressing piece 22 in the thread locking state, the thread pressing piece 22 has a tendency to reverse in the direction close to the self-locking inclined surface 231, but since the curvature radius of the self-locking segment 221 gradually increases from the second end position B to the first end position A, the thread pressing piece 22 with a reversal tendency will produce a greater squeezing force on the retaining piece 23, and the squeezing force further causes the retaining piece 23 to produce a greater force on the main body 21, thereby increasing the friction between the main body 21 and the retaining piece 23, and helping to prevent the retaining piece 23 from moving in the opposite direction on the main body 21, so as to ensure that the second position D of the self-locking inclined surface 231 continues to abut against the second end position B of the self-locking segment 221, and avoid the thread pressing piece 22 from rotating relative to the main body 21 in the direction close to the self-locking inclined surface 231, thereby improving the reliability of the self-locking function of the thread pressing piece 22 and preventing the suture 2 from loosening.

[0065] Preferably, in one embodiment of the present application, an acute angle α is formed between the self-locking inclined surface 231 and the guide sliding surface 211 , and the acute angle α is less than or equal to 45 degrees, and more preferably 30 degrees.

[0066] Please refer to Figure 4 、 Figure 5 、 Figure 6 and Figure 7 In one embodiment of the present application, in order to ensure the effective driving of the locking process of the anchor assembly 1, the wire pressing member 22 is configured as a lever structure, including a rotating portion 222, and a driving portion 223 and a wire pressing portion 224 arranged on both sides of the rotating portion 222. The rotating portion 222 is rotatably connected to the main body 21, and the self-locking section 221 is arranged on the rotating portion 222. The driving portion 223 can be actuated by an actuator 40 to drive the wire pressing portion 224 and the self-locking section 221 to rotate. Specifically, the driving portion 223 is used to drive the rotating portion 222 to rotate under the action of the traction external force of the actuator 40, so that the wire pressing portion 224 is pressed against the main body 21 or separated from the main body 21.

[0067] The rotating portion 222 is generally cylindrical, with the thread pressing portion 224 protruding from one end of the cylindrical surface of the rotating portion 222 for cooperating with the main body 21 to compress the suture 2. The driving portion 223 protrudes from the other end of the cylindrical surface of the rotating portion 222 for removable engagement with the actuator 40. The thread pressing portion 224 and the driving portion 223 that drives the thread pressing portion 224 are effectively isolated by the main body 21, thereby ensuring that the suture 2 and the actuator 40 that drives the driving portion 223 are isolated from each other, avoiding the problem of interference between the two due to their close proximity.

[0068] Among them, when the anchor assembly 1 is in the initial state, the wire pressing part 224 is separated from the main body 21, and the retaining part 23 abuts the first end A of the self-locking segment 221, and the suture 2 is in a released state; when the anchor assembly 1 is in the wire locking state, the wire pressing part 224 abuts against the main body 21 under the drive of the driving part 223 and the rotating part 222, and presses the suture 2 onto the main body 21, and the retaining part 23 abuts the second end B of the self-locking segment 221, and the suture 2 is in a locked state.

[0069] Furthermore, in order to ensure the removable engagement of the actuator 40 and the driving portion 223, the driving portion 223 has a coupling end, and the distal end of the actuator 40 is removably coupled to the coupling end. Thus, under the control of the operator, the actuator 40 is axially actuated in a substantially horizontal direction toward the proximal end, and the driving portion 223 can generate a torque under the axial actuation of the actuator 40 to drive the rotating portion 222 to rotate. Specifically, the driving portion 223 includes two rods that are protruded side by side and spaced apart from each other on the rotating portion 222, and form a accommodating space with the coupling end. Wherein, after the main body 21 is at least partially accommodated in the accommodating space, the other part of the main body 21 is respectively positioned on both sides of the wire pressing member 22. At this time, the wire pressing member 22 is pivotally connected to the main body 21 by utilizing a connecting structure, and the above-mentioned connecting structure is described in detail later.

[0070] Specifically, the joint end may include a winding shaft with a smooth outer surface, which extends or is connected between the two rods and is disposed away from the wire pressing portion 224. Figure 22As shown, the actuator 40 is a flexible traction member that can be removably connected to the winding shaft by rewinding its distal end. The flexible traction member can be, for example, a metal wire such as stainless steel wire, nickel-titanium wire, or tungsten wire; a metal rope such as stainless steel wire rope, tungsten wire rope, or nickel-titanium wire rope; or a polymer rope or thread such as PET medical thread, PTFE rope, or ultra-high molecular weight polyethylene medical thread. It is understood that the winding shaft can have a closed cross-section of various shapes, such as square, circular, or polygonal. To ensure smooth retraction of the actuator 40 from the winding shaft, a circular cross-section is preferred. The rod can be straight or curved. Curved rods can increase bending stress on the rod, reducing the risk of fracture. To further prevent the flexible traction member from detaching from the outer surface of the winding shaft, potentially causing actuation failure, in some embodiments, the engagement end includes a protrusion located on the side of the rod adjacent to the winding shaft to prevent the flexible traction member from detaching from the winding shaft when the rod is loose. Alternatively, the joint end may further include traction holes, with two traction holes formed axially through the outer surface of the winding shaft, and the distal end of the flexible traction member looping through the two traction holes in an open loop. Alternatively, the diameter of the winding shaft may be configured to gradually increase from the center toward both ends to minimize the possibility of maintaining the flexible traction member in the center of the winding shaft for a long period of time. Alternatively, the joint end may further include an anti-slip shaft disposed between the two rods and adjacent to the winding shaft to prevent the flexible traction member from detaching from the winding shaft.

[0071] In the embodiment provided in the present application, the length of the driving portion 223 is greater than the length of the thread pressing portion 224, which allows the thread pressing member 22 to form a labor-saving mechanism, which is more conducive to driving the thread pressing member 22 to achieve thread locking. For example, the length of the thread pressing portion 224 is L1, and the pressing force required for the thread pressing portion 224 to compress the suture 2 is F1; the length of the driving portion 223 is L2, and the actuating force applied to the winding shaft by the actuator 40 is F2. Based on the lever principle, the relationship between the four should satisfy the formula F1*L1=F2*L2. Therefore, when L2>L1, the thread pressing member 22 is a labor-saving lever. At this time, a smaller actuating force F2 can be used to generate a larger pressing force F1 to lock the suture 2.

[0072] Please refer to Figure 2 、 Figure 3 and Figure 6In one embodiment of the present application, the thread pressing portion 224 is provided with a first thread passing channel 225 for the suture 2 to pass through. After the suture 2 passes through the first thread passing channel 225, it is located between the main body 21 and the thread pressing portion 224, and can be moved toward the main body 21 under the drive of the thread pressing portion 224 until the thread pressing portion 224 is pressed against the main body 21. Specifically, the inner diameter of the first thread passing channel 225 is larger than the diameter of the suture 2 to allow the suture 2 to move freely. In this embodiment, by providing the first thread passing channel 225 for the suture 2 to pass through on the thread pressing portion 224, the radial movement of the suture 2 along the main body 21 can be restricted. When the suture 2 is pressed between the thread pressing portion 224 and the main body 21, the axial movement of the suture 2 along the main body 21 can be restricted, thereby achieving the locking of the suture 2.

[0073] Please refer to Figure 8 In one embodiment of the present application, the main body 21 includes a main body portion 212 having a substantially rectangular parallelepiped structure, an end plate 213 connected to one end of the main body portion 212 close to the retaining member 23, and a pair of support portions 214 connected to the outer peripheral wall of the end plate 213 and extending along the length direction of the main body portion 212 toward the direction close to the wire pressing member 22. Figure 2 、 Figure 3 and Figure 8 As shown, the main body 212 has a guide sliding surface 211 for movably setting the retaining member 23 on the side facing the wire pressing member 22, and a pair of support portions 214 are connected to the outer peripheral wall of the end plate 213 and are spaced apart on opposite sides of the width direction of the main body 212, and each support portion 214 extends beyond the guide sliding surface 211 of the main body 212. Among them, the main body 212, the end plate 213 and the pair of support portions 214 jointly define a receiving space located on one side of the guide sliding surface 211, and the wire pressing member 22 and the retaining member 23 are both disposed in the receiving space.

[0074] In one embodiment of the present application, a first through hole is formed at one end of each support portion 214 away from the end plate 213 along the width direction of the main body 212, and a second through hole is formed at the rotating portion 222 of the wire pressing member 22. The anchor assembly 1 further includes a connecting shaft 24, which is inserted into the corresponding first and second through holes, so that the wire pressing member 22 is rotatably connected to the pair of support portions 214 of the main body 21 around the connecting shaft 24. The connecting shaft 24 can be fixed to the support portion 214 by means of threaded connection, welding, bonding, etc., and welding is preferred for reliability considerations.

[0075] In other embodiments, the wire pressing member 22 may also be provided with a pair of connecting shafts protruding on opposite sides of the rotating portion 222, and the pair of connecting shafts are correspondingly installed in a pair of first through holes of a pair of support portions 214, so that the wire pressing member 22 is rotatably connected to the pair of support portions 214 of the main body 21 around the pair of connecting shafts, thereby eliminating the need for the connecting shafts 24 of a separate component and simplifying the structure of the anchor assembly 1. Of course, in other embodiments, each support portion 214 may also be provided with a connecting shaft protruding toward the other support portion 214, and the two connecting shafts of a pair of support portions 214 are installed in the second through holes of the wire pressing member 22, which can also enable the wire pressing member 22 to be rotatably connected to the pair of support portions 214 of the main body 21 around the pair of connecting shafts, thereby eliminating the need for the connecting shafts 24 of a separate component and simplifying the structure of the anchor assembly 1.

[0076] Please refer to Figure 2 、 Figure 3 and Figure 8 In one embodiment of the present application, the main body 21 is provided with a second wire passage 215 , and the suture 2 passes through the first wire passage 225 and the second wire passage 215 and then passes through the anchor assembly 1 .

[0077] Specifically, a guide portion 216 extends radially from one end of the main member 21 away from the retaining member 23 and in a direction perpendicular to the guide surface 211. The guide portion 216 and the wire pressing portion 224 are located on the same side of the main member 21. The guide portion 216 defines a second wire passage 215. The suture 2 axially passes through the connected second wire passage 215 and the first wire passage 225 before exiting the anchor assembly 1. Specifically, the inner diameter of the second wire passage 215 is larger than the diameter of the suture 2 to allow for free movement of the suture 2.

[0078] In this embodiment, by providing a second wire-passing channel 215 on the guide portion 216 of the main body 21 that communicates with the first wire-passing channel 225, the radial movement of the suture 2 along the main body 21 can be further restricted. At the same time, under the dual restriction of the second wire-passing channel 215 and the first wire-passing channel 225, it can be ensured that the suture 2 is partially located between the main body 21 and the wire-pressing portion 224, ensuring that the wire-pressing portion 224 can press the suture 2 after rotation. The first wire-passing channel 225 and the second wire-passing channel 215 include, but are not limited to, circular holes, elliptical holes, or other shaped holes, which are not limited in this application.

[0079] Specifically, in order to improve the locking force of the suture 2 located between the main body 21 and the thread pressing piece 22, a bearing surface extending in at least two directions is provided on the main body portion 212 of the main body 21, and the thread pressing portion 224 of the thread pressing piece 22 is provided with a thread pressing surface that cooperates with the bearing surface. The suture 2 can be pressed onto the bearing surface by the thread pressing surface to form a lock extending in at least two directions.

[0080] Please refer to Figure 9and Figure 10 A smooth inner surface is formed between the guide portion 216 of the main body 212 and the main body 212, and the bearing surface is at least a portion of the surface of the smooth inner surface. In order to ensure the effective length of the suture 2 locked, the bearing surface includes a first bearing surface, a second bearing surface, and a third bearing surface connected to form a U-shaped bearing surface extending in a roughly U-shaped manner. Among them, the first bearing surface is a partially curved surface on the inner side of the guide portion 216 and extends roughly in the radial direction. The first bearing surface is located below the second wire-passing channel 215, that is, between the second wire-passing channel 215 and the main body 212. The second bearing surface is a portion of the surface on the main body 212 that is connected to the first bearing surface and close to the guide portion 216. The second bearing surface extends roughly in the axial direction. A protrusion 217 is further provided on the second bearing surface. A gap is formed between the protrusion 217 and the guide portion 216 to accommodate at least a portion of the wire pressing portion 224. The third bearing surface is the surface on the protrusion 217 opposite to the first bearing surface and connected to the second bearing surface. At the same time, the pressing surface is at least one end surface of the pressing portion 224, including a first pressing surface that cooperates with the first bearing surface, a second pressing surface that cooperates with the second bearing surface, and a third pressing surface that cooperates with the third bearing surface, so as to form a U-shaped pressing surface that extends roughly in a U shape. Among them, the first pressing surface is roughly parallel to the longitudinal center axis of the first wire-passing channel 225, the second pressing surface is the end surface extending from the first pressing surface to the first wire-passing channel 225 and close to the bearing surface, and the third pressing surface is the inner surface of the first wire-passing channel 225 connected to the second pressing surface. Therefore, under the cooperation of the bearing surface and the pressing surface, the suture 2 can be squeezed and deformed by the main body 21 and the pressing member 22 to form a locking length that is roughly U-shaped, so as to improve the locking force.

[0081] It is understandable that the cross-section of the protrusion 217 must be smaller than the aperture of the first wire passing channel 225 of the wire pressing member 22. Therefore, when the wire pressing member 22 uses the wire pressing surface to press and lock the suture 2 to the bearing surface, the protrusion 217 will be accommodated in the first wire passing channel 225. In some embodiments, an acute angle is formed between the first bearing surface and the second bearing surface; given that the smaller the angle of the acute angle, the more inclined the guide portion 216 is relative to the main body 212, which in turn causes the axial dimension of the guide portion 216 to be larger: and, when the wire pressing portion 224 presses the suture 2 to the bearing surface, if the acute angle is too small, it is more likely to cause the risk of suture 2 breaking; therefore, the range of the acute angle is 30 degrees to 90 degrees, and the present application preferably selects 60 degrees. However, the angle between the third bearing surface and the second bearing surface is an obtuse angle, and the present application preferably selects an obtuse angle of 120 degrees. Of course, in other embodiments, the main body 21 may not include the protrusion 217. In this case, the suture 2 will be pressed to the first bearing surface by the first pressing surface and to the second bearing surface by the second pressing surface to form a roughly L-shaped locking length.

[0082] Please refer to Figure 4 、 Figure 5 and Figures 8-16 In one embodiment of the present application, the retaining member 23 includes a push-up member 232 and an elastic member 233. The self-locking inclined surface 231 is provided on the push-up member 232. The elastic member 233 is provided on the side of the push-up member 232 away from the wire pressing member 22 and is axially compressed between the push-up member 232 and the main body 21. The elastic member 233 is used to provide elastic thrust to push the push-up member 232. In some embodiments, the push-up member 232 and the elastic member 233 are two independent components. In this case, the retaining member 23 can be as follows: Figure 13 and Figure 15 In other embodiments, the push member 232 and the elastic member 233 are integrally formed. In this case, the retaining member 23 can be as follows: Figure 16 The elastic single member shown.

[0083] Specifically, if Figure 11-Figure 15 As shown, the push member 232 is a block with a roughly L-shaped structure and includes a guide column 234 arranged away from the self-locking inclined surface 231. The self-locking inclined surface 231 extends a certain distance from the side of the push member 232 away from the guide column 234 to the side close to the guide column 234. The elastic member 233 (such as a spring or a spring) is axially sleeved on the guide column 234. The main body 21 is provided with a guide hole 219 extending axially (i.e., in the length direction of the main body 212), and the guide column 234 is at least partially accommodated in the guide hole 219 and can move axially relative to the guide hole 219. Specifically, the guide column 234 is at least partially accommodated in the guide hole 219 and can move axially relative to the guide hole 219, which can limit the elastic member 233 to push the retaining member 23 to move axially along the main body 21 on the guide sliding surface 211. Specifically, in Figure 2 、 Figure 3 and Figure 8 In the example, the guide hole 219 is provided on the side of the end plate 213 facing the elastic member 233, and the end of the guide post 234 away from the self-locking inclined surface 231 is exposed to the end plate 213 through the guide hole 219. The shape of the axial cross section of the guide post 234 and the shape of the guide hole 219 are adapted to each other, and can be, but not limited to, oval, circular, cross-shaped, etc. The shape of the axial cross section of the guide post 234 and the shape of the guide hole 219 are preferably oval, and the long axis direction of the oval extends along the width direction of the main body 212. In this way, the retaining member 23 can be limited to not moving in the radial direction of the main body 21 (i.e., the direction perpendicular to the guide surface 211) when it moves on the guide surface 211, which helps to improve the movement stability of the retaining member 23.

[0084] In the first embodiment of this application, please refer to Figures 11 to 14The elastic member 233 includes a U-shaped spring piece, which includes two open ends and a curved end connected to the open ends. The two open ends abut against the two positioning grooves of the end plate 213 of the main body 21, and the curved end abuts against the abutting member 232. The curved end is provided with a through hole for the guide column 234 to pass through. In the second embodiment of the present application, Figure 15 As shown, the elastic member 233 may also be a spring, which is sleeved on the guide column 234 and compressed between the push member 232 and the end plate 213 of the main member 21 , and can also push the retaining member 23 .

[0085] Please refer to Figure 16 In another embodiment of the present application, the abutting member 232 and the elastic member 233 are integrally formed. The abutting member 232 is a wedge-shaped block, and the elastic member 233 is a columnar or sheet-like structure protruding from the end of the wedge-shaped block away from the self-locking inclined surface 231. At least the axial portion of the elastic member 233 is elastic, allowing for axial compression and expansion. A guide groove is defined on the side of the end plate 213 facing the retaining member 23. The elastic member 233 always abuts within this guide groove, elastically compressing axially between the wire pressing member 22 and the end plate 213.

[0086] Please refer to Figure 17 The radial dimension of the anchor 10 is larger than the dimension of the invasion point (puncture point) to provide sufficient anchoring force. For example, the anchor 10 can include a helical anchor or a barbed spring. The following description uses a helical anchor as an example, which should not be construed as limiting the present application.

[0087] Specifically, if Figure 17 and Figure 18 As shown, the main body 21 is provided with an axially extending receiving channel 218 for rotationally connecting with the proximal end of the anchor 10. The anchor 10 includes a helical coil 11 and a connector 12 disposed at the proximal end of the helical coil 11. The helical coil 11 is located at the distal end of the main body 21 for engagement with the target tissue. The connector 12 is at least partially rotatably received in the receiving channel 218 and cannot axially disengage from the receiving channel 218.

[0088] The helical coil 11 includes a helical segment with a sharp distal end for engaging with target tissue and an axial connecting segment formed by transitioning from the proximal end of the helical segment. The axial connecting segment is coaxially arranged with the helical segment to ensure that the anchor 10 does not experience radial runout when anchored. The connecting member 12 is generally hollow and tubular, including a hollow inner cavity extending axially for at least partially accommodating the axial connecting segment of the helical coil 11. Furthermore, an installation window is provided at the side end of the accommodating channel 218, which is connected to the accommodating channel 218. The installation window allows the anchor 10 to be viewed and installed in the accommodating channel 218. During installation, the axial connecting section of the spiral coil 11 is inserted into the distal end of the accommodating channel 218, and the connecting member 12 is inserted into the proximal end of the accommodating channel 218. Then, at least the proximal portion of the axial connecting section is inserted into and fixed to at least the distal portion of the hollow inner cavity of the connecting member 12 at the installation window. For example, an installation tool can be used to fix the two by laser welding at the installation window. Of course, other methods such as soldering, brazing, and adhesives can also be used for fixation.

[0089] Continue reading Figure 17 and Figure 18 To ensure that the anchor 10 can rotate circumferentially relative to the main body 21 after installation, while the two remain axially fixed and inseparable, the present application provides a receiving channel 218 with at least two sections of varying radial dimensions: a proximal channel for accommodating at least a portion of the connector 12, and a distal channel for accommodating at least a portion of the axial connecting section. The proximal and distal channels are interconnected to form the receiving channel 218. The proximal channel has a larger diameter and axial length than the distal channel. The intermediate axial connecting section between the helical section and the connector 12 is accommodated within the distal channel. The radially larger helical sections and the connector 12 axially constrain the smaller intermediate axial connecting section within the distal channel, thereby ensuring that the anchor 10 remains axially inseparable from the main body 21. In some embodiments, the cross-sectional shape of the receiving channel 218 is a circular stepped structure, allowing the anchor 10 to rotate relative to the main body 21.

[0090] It should be noted that the anchor 10, the main body 21, the wire pressing member 22, and the retaining member 23 are all human implants. The anchor 10, the main body 21, the wire pressing member 22, and the retaining member 23 can include but are not limited to materials with good biocompatibility such as nickel-titanium alloy and 316 stainless steel.

[0091] Please refer to Figure 17 and Figure 18In one embodiment of the present application, in order to avoid the wear and tear of the suture 2 when it moves in the second wire passage 215 of the main body 21 or the second wire passage 215 of the wire pressing member 22, thereby causing irreversible damage to the suture 2 and the risk of easy breakage, the present invention further deploys a buffer 30 on the anchor assembly 1 to protect the suture 2 and improve the fatigue performance of the suture 2. Specifically, the anchor assembly 1 also includes a buffer 30, and the buffer 30 is deployed on at least a portion of the surface of the first wire passage 225 and / or the second wire passage 215 to reduce the hardness of the surface of the first wire passage 225 and / or the surface of the second wire passage 215. In this embodiment, the buffer 30 is deployed on at least a portion of the surface of the first wire passage 225 and the second wire passage 215. In other embodiments, the buffer 30 is deployed on at least a portion of the surface of the first wire passage 225 or the second wire passage 215. This application does not limit this.

[0092] In one embodiment of the present application, the buffer member 30 includes a coating applied to the surface of the first wire passage 225 and / or the surface of the second wire passage 215, or a film or a flexible member covering the surface of the first wire passage 225 and / or the surface of the second wire passage 215. The coating, film, and flexible member are all made of a material with a lower hardness than the material of the main body 21 and the wire pressing member 22. Therefore, by providing the coating, film, or flexible member in contact with the suture 2, direct contact between the suture 2 and the first wire passage 225 of the main body 21 and the second wire passage 215 of the wire pressing member 22 can be avoided, thereby preventing wear and other phenomena caused by the suture 2 coming into direct contact with the first wire passage 225 of the main body 21 and the second wire passage 215 of the wire pressing member 22.

[0093] In this embodiment, the flexible member is a cloth cover, which is a tubular body with a certain wall thickness and has an inner lumen for passing the suture 2. Optionally, the cloth cover includes but is not limited to being fixed to the surface of the first wire channel 225 or the second wire channel 215 by adhesive bonding or suturing; and the cloth cover includes but is not limited to a PET braided tube or other polymer material with similar material properties to the suture 2, and the wall thickness of the cloth cover ranges from 0.05mm to 0.10mm, preferably 0.05mm. Of course, in other embodiments, the flexible member is a flexible wire, which can be wrapped around the surface of the first wire channel 225 and / or the surface of the second wire channel 215.

[0094] Please refer to Figure 19 It should be noted that the present application also provides a delivery device, which is detachably connected to the anchor assembly 1. The delivery device is used to transport the anchor assembly 1 to the target tissue area for anchoring. The specific structure of the delivery device is described in detail below with reference to the accompanying drawings.

[0095] Please refer to Figure 20 and Figure 21In one embodiment of the present application, the delivery device includes, from the inside out, an actuator 40, a driver 50, a positioning needle 60, an outer tube assembly 70, and a proximal handle assembly 82. The proximal end of the tube assembly 70 is connected to the handle assembly 82. The actuator 40, the positioning needle 60, and the driver 50 are installed in parallel in the inner cavity of the tube assembly 70 and extend proximally to be connected to the handle assembly 82. The inner cavity of the tube assembly 70 is also used to pass the suture 2. The anchor assembly 1 is pre-loaded on the distal end of the tube assembly 70 and is detachably connected to the distal ends of the actuator 40 and the driver 50, respectively. The distal end of the positioning needle 60 is pre-loaded in the buffer 30 and is arranged in parallel with the suture 2 passed through the buffer 30.

[0096] Please refer to Figure 22 and Figure 23 The distal end of the actuator 40 is detachably connected to the driving portion 223 of the wire pressing member 22 in a releasable manner, and is used to drive the wire pressing member 22 to rotate a certain angle around the connecting shaft 24, so that a certain gap t is formed between the wire pressing surface of the wire pressing portion 224 and the bearing surface of the main body 21. When the gap t is smaller than the outer diameter of the suture 2, the suture 2 is squeezed and deformed, and further sliding of the suture 2 requires overcoming the resistance and friction required for deformation, thereby achieving thread locking.

[0097] Preferably, please refer to Figure 22 The actuator 40 is a flexible traction member and can be connected to the driving part 223 in a winding manner, that is, the two free ends of the actuator 40 are connected to the proximal handle assembly 82. When the wire locking is completed, the operator manipulates the proximal handle assembly 82 to release any one or both free ends of the actuator 40, and pulls it out along one of the free ends to realize the disengagement of the actuator 40 from the driving part 223 of the wire pressing member 22.

[0098] Alternatively, see Figure 23 In another embodiment of the present application, the actuator 40 may also be a connecting rod made of a rigid material. When the actuator 40 is rigid, the connection between the actuator 40 and the drive unit 223 may be a threaded connection, i.e., one end of the actuator 40 is threadedly connected to the drive unit 223, and the other end is connected to the proximal handle assembly 82. After the thread is locked, the operator operates the proximal handle assembly 82 to rotate the actuator 40 relative to the drive unit 223, thereby disengaging the threads and thereby disengaging the actuator 40 from the drive unit 223.

[0099] Please refer to Figure 24 and Figure 25The proximal end of the connector 12 is provided with an engagement portion for removably engaging with a driver 50, which is capable of driving the anchor 10 to rotate relative to the lockwire assembly 20. Specifically, the driver 50 includes a drive shaft 51 and a release lever 52. The drive shaft 51 is a hollow tubular structure, and the distal end of the drive shaft 51 is provided with a mating portion. The mating portion cooperates with the engagement portion to achieve a detachable connection between the connector 12 and the drive shaft 51. Optionally, the mating portion and the engagement portion may be connected in a manner including, but not limited to, an S-shaped connection.

[0100] Furthermore, the release lever 52 is located within the hollow tube of the drive shaft 51 and is axially movable and rotatable along the hollow tube. When the release lever 52 is in the connected position between the mating portion and the joint portion, the drive shaft 51 can be used to move the connector 12 and the anchor assembly 1 together to achieve implantation of the anchor assembly 1. When the release lever 52 is withdrawn from the connected position between the mating portion and the joint portion, the mating portion and the joint portion can move relative to each other, allowing the drive shaft 51 to radially displace relative to the connector 12, thereby removing the drive shaft 51 and the release lever 52 from the body to achieve release of the driver 50.

[0101] Specifically, if Figure 26-Figure 27 As shown, the drive shaft 51 further includes a flexible section 511 connected to the mating portion and a main body section 512 extending to the proximal end. Figure 26 As shown, the drive shaft 51 can also be formed into a whole by fixing the flexible section 511 and the main section 512 by welding or bonding. In this case, the flexible section 511 of the drive shaft 51 can be a cutting tube or a multi-strand flexible shaft. The multi-strand flexible shaft has better torque transmission efficiency than the cutting tube. In other embodiments, such as Figure 27 As shown, the drive shaft 51 can be an integrated cutting hose, and the distal end of the cutting hose is cut with multiple cutting segments to form the flexible segment 511 of the drive shaft 51 .

[0102] Please refer to Figure 28 and Figure 29The tube body assembly 70 includes a sleeve 71 at the distal end and a flexible tube body 72 extending all the way to the proximal handle assembly 82. The inner cavity of the sleeve 71 is used to accommodate the anchor assembly 1, and at least one U-shaped groove 711 extending axially is arranged on the circumference of the sleeve 71 to be used to introduce the suture 2 from the U-shaped groove 711 into the buffer member 30 of the anchor assembly 1. Furthermore, the guide portion 216 of the main body 21 is circumferentially limited in the U-shaped groove 711, but can move axially along the U-shaped groove 711. Of course, in order to ensure that the main body 21 of the anchor assembly 1 does not move radially due to squeezing the suture 2 when the anchor assembly 1 is locking the thread, a positioning end 2161 with an increased width is provided at the end of the guide portion 216 away from the guide sliding surface 211. The positioning end 2161 is disposed on a side of the U-shaped groove 711 away from the inner cavity of the sleeve 71 and abuts against the U-shaped groove 711 . The positioning end 2161 cooperates with the U-shaped groove 711 to radially limit the main body 21 .

[0103] The material of sleeve 71 must have a certain degree of support strength to provide the support force required for the thread locking process. Optionally, the material of sleeve 71 includes, but is not limited to, polymer materials, stainless steel, or other hard materials, which are not limited in this application. Optionally, sleeve 71 and flexible tube body 72 may be connected by, but are not limited to, gluing, welding, or other connection methods.

[0104] The following will be combined Figure 2 、 Figure 3 、 Figures 30 to 40 , taking the application of suture 2 in artificial chordal implantation as an example, the use process of the anchor assembly 1 and the delivery device provided in the embodiment of the present application is explained.

[0105] The first step, such as Figure 30 As shown, a suturing device (not shown) is delivered through a delivery sheath 81 to fix the distal end of the inner suture 2 to the leaflet. After completing the leaflet suturing operation at the leaflet end, the suturing device is withdrawn to leave the suture 2. At this time, the proximal end of the suture 2 extends from the leaflet and extends to the outside of the body through the delivery sheath 81.

[0106] The second step is Figure 31 As shown, the anchor assembly 1 is delivered to the target tissue area along the suture 2 and the delivery sheath 81 using a delivery device. In this embodiment, the target tissue area is near the papillary muscle in the ventricle.

[0107] The third step, such as Figure 32As shown, the bending direction of the tube body assembly 70 is adjusted so that its distal opening points to the anchoring position on the papillary muscle, and the positioning needle 60 is pushed axially distally (manual axial push or control handle assembly 82 drive) to push the positioning needle 60 out of the distal opening of the buffer member 30 and penetrate into the target tissue to prevent the anchor assembly 1 or the distal end of the delivery device from slipping during the beating of the heart, which may cause the anchoring position to be inconsistent with the target position.

[0108] The fourth step is as follows Figure 33 As shown, the handle assembly 82 of the delivery device is controlled or manually screwed to actuate the driver 50 to spirally advance distally, thereby driving the entire anchor assembly 1 to spirally advance distally, thereby rotating the anchor 10 and embedding it into the papillary muscle. At this time, the anchor 10 spirals distally, and the locking wire assembly 20 moves axially distally along the U-shaped groove 711 under the restriction of the U-shaped groove 711. After anchoring is completed, the positioning needle 60 is withdrawn into the interior of the flexible tube 72.

[0109] Step 5: Figure 34 and Figure 35 As shown, a certain pulling force is applied to the proximal end of the suture 2 in vitro or the handle assembly 82 is controlled to adjust the tension of the suture 2 to limit the range of motion of the valve leaflet and restore it to a normal state. Then, the actuator 40 is manually pulled proximally or the handle assembly 82 is controlled to drive the actuator 40, thereby actuating the thread pressing member 22 to rotate around the connecting shaft 24 under force to the thread locking state that compresses the suture 2, thereby completing the thread locking.

[0110] Step 6: Figure 36 As shown, the actuator 40 is separated from the driving portion 223 of the wire pressing member 22, and the actuator 40 is withdrawn. Figure 37 and Figure 38 As shown, after the driver 50 is separated from the engaging portion of the connector 12 , the delivery device is withdrawn to leave the suture 2 behind.

[0111] Step 7: Figure 39 As shown, the cutting device 83 is delivered to the vicinity of the anchor assembly 1 through the delivery sheath 81 to cut the suture 2 near the anchor assembly 1. Finally, as shown in FIG. Figure 40 As shown, the cutting device 83 and the delivery sheath 81 are withdrawn, and the anchor assembly 1 remains in the patient's body. The cut suture 2 will be used as an artificial tendon to replace the diseased or broken native tendon, thereby achieving heart valve repair.

[0112] It is understandable that the anchor assembly 1 can be used in the field of artificial chordae tendineae implantation of heart valves, as well as in the fields of annulus contraction and ventricular reconstruction to repair heart function.

[0113] The above is part of the implementation methods of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application. These improvements and modifications are also considered to be within the scope of protection of the present application.

Claims

1. An anchor assembly for anchoring a suture to a target tissue, characterized in that: include: an anchor for engaging the target tissue; as well as A wire locking assembly, comprising: a main body member connected to the proximal end of the anchor member; a thread pressing member movably connected to the main body, the suture being passed through the main body and the thread pressing member, and the thread pressing member being actuated to move relative to the main body and press the suture; and a retaining member, the retaining member being located between the main body and the thread pressing member, the retaining member being configured to maintain the thread pressing member in a position for squeezing the suture; In which, the wire pressing member is rotatably connected to the main body and has a self-locking section, the main body has a guide sliding surface, the retaining member is slidably arranged on the guide sliding surface, and the self-locking section is isolated by the retaining member to form a gap with the guide sliding surface; the wire pressing member drives the self-locking section to rotate relative to the main body to increase the gap so that the retaining member can slide toward the wire pressing member.

2. The anchor assembly according to claim 1, wherein: The retaining member is elastic, and the increase in the gap causes the retaining member to break away from the abutment of the self-locking section and generate elastic displacement to slide toward the wire pressing member.

3. The anchor assembly according to claim 2, wherein: The retaining member has a self-locking inclined surface that cooperates with the self-locking section. The elastic displacement of the retaining member causes the self-locking section to move from a first position of the self-locking inclined surface to a second position of the self-locking inclined surface. The distance from the first position to the guide sliding surface is smaller than the distance from the second position to the guide sliding surface.

4. The anchor assembly according to claim 3, characterized in that The self-locking section is a curved surface with a gradually decreasing curvature radius.

5. The anchor assembly according to claim 3, characterized in that The included angle α between the self-locking inclined surface and the guide sliding surface satisfies: α≤45 degrees.

6. The anchor assembly according to claim 3, characterized in that The retaining member includes a push member and an elastic member, the self-locking inclined surface is provided on the push member, and the elastic member is provided on a side of the push member away from the wire pressing member and is axially compressed between the push member and the main body.

7. The anchor assembly according to claim 6, characterized in that The push member includes a guide column arranged away from the self-locking inclined surface, and the elastic member is axially sleeved on the guide column; the main body is provided with an axially extending guide hole, and the guide column is at least partially accommodated in the guide hole and can move axially relative to the guide hole.

8. The anchor assembly according to claim 1, wherein: The wire pressing part includes a rotating part, and a driving part and a wire pressing part arranged on both sides of the rotating part. The rotating part is rotatably connected to the main body, and the self-locking section is arranged on the rotating part; the driving part can be actuated by an actuator to drive the wire pressing part and the self-locking section to rotate.

9. The anchor assembly according to claim 8, characterized in that The wire pressing portion is provided with a first wire passing channel, and the main body is provided with a second wire passing channel. The suture passes through the first wire passing channel and the second wire passing channel and then passes out of the anchor assembly.

10. The anchor assembly according to claim 9, wherein: The anchor assembly further includes a buffer disposed on at least a portion of the surface of the first wire passage and / or the second wire passage to reduce the hardness of the surface of the first wire passage and / or the second wire passage.

11. The anchor assembly according to claim 10, wherein: The buffer component includes a coating applied to the surface of the first wire passing channel and / or the surface of the second wire passing channel, or a film or a flexible component covering the surface of the first wire passing channel and / or the surface of the second wire passing channel.

12. The anchor assembly according to claim 1, wherein: The main body is provided with an axially extending accommodating channel, and the anchoring member includes a spiral coil and a connecting member provided at the proximal end of the spiral coil. The spiral coil is located at the distal end of the main body for coupling to the target tissue, and the connecting member is at least partially rotated and accommodated in the accommodating channel.

13. The anchor assembly according to claim 12, wherein: The proximal end of the connecting member is provided with an engagement portion for removably engaging with a driver, and the driver is capable of driving the anchor member to rotate relative to the lock wire assembly.

14. The anchor assembly according to claim 1, wherein: The main body has a guide portion radially extending in a direction perpendicular to the guide sliding surface, and an end of the guide portion away from the guide sliding surface is provided with a positioning end with an increased width.

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