Anchor assembly

Abstract

The invention provides an anchor assembly which comprises an anchoring part and a suture locking assembly, the anchoring part is used for being connected with target tissue, the suture locking assembly comprises a main body part, a suture pressing part and a maintaining part, the main body part is connected with the near end of the anchoring part, the suture pressing part is movably connected to the main body part, and a suture is arranged between the main body part and the suture pressing part in a penetrating mode. The thread pressing piece can be actuated to move relative to the main body piece and extrude the thread, and the maintaining piece is located between the main body piece and the thread pressing piece and is configured to maintain the thread pressing piece at the position where the thread is extruded. When the anchoring device assembly is applied to locking of a suture, an operator can firstly install the suture between the main body piece and the suture pressing piece in a penetrating mode, then the anchoring device assembly is anchored to target tissue through the anchoring piece, and then the suture pressing piece is actuated to move relative to the main body piece so that the suture can be pressed to the main body piece. And the retaining piece is used for retaining the thread pressing piece at the position for extruding the suture, so that the anchoring stability and effectiveness of the anchoring device assembly are maintained.

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) is one of the most common valvular diseases and 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 flows from the ventricle to the aorta, the valve leaflets are completely closed under the traction of the chordae tendineae to prevent 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 to the atrium, causing mitral regurgitation.

[0003] For example, for the problem of incomplete mitral valve coaptation caused by chordal disease or rupture, the prior art usually uses artificial chord implantation to fix one end of the suture to the leaflet of the mitral valve, and uses a locking assembly to anchor the other end of the suture to the ventricular tissue to form an artificial chord, thereby replacing the native chord structure of the mitral valve. However, the locking assembly in the prior art does not provide a continuous and reliable self-locking structure to resist continuous heart beating, which results in the inability of the locking assembly to remain in the locking position for a long time, and in severe cases may cause the risk of locking failure; that is, the stability and effectiveness of the locking assembly locking line are facing great challenges. Summary of the invention

[0004] The purpose of the present application is to provide an anchor assembly with a self-locking function, so as 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 anchoring of the anchor assembly.

[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, the wire locking assembly comprising:

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

[0009] A thread pressing member, the thread pressing member is movably connected to the main body, the suture is passed through the main body and the thread pressing member, and the thread pressing member can be 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 by 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 press the suture to the main body by actuating the wire pressing piece to move to the wire locking state relative 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 wire 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, so as to 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 drawings required for use in the embodiments will be briefly introduced below. 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 It is a three-dimensional structural schematic diagram of an anchor assembly provided in an embodiment of the present application;

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

[0015] Figure 3 It is a schematic cross-sectional structure 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 It is a three-dimensional structural schematic diagram of a wire crimping member provided in an embodiment of the present application;

[0019] Figure 7 It 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 It is a schematic diagram of a three-dimensional structure of a main body provided in an embodiment of the present application;

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

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

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

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

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

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

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

[0028] Fig.16 It is a schematic diagram of the cross-sectional structure of an anchor assembly when a guide column provided in an embodiment of the present application is an elastic member;

[0029] Fig.17 It is a structural schematic diagram of the cooperation between an anchor and a locking wire assembly provided in an embodiment of the present application;

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

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

[0032] Fig.21 It is a schematic diagram of the structure of a delivery device and an anchor assembly provided in an embodiment of the present application;

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

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

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

[0036] Fig.25 It is a schematic diagram of releasing a driver and an anchor provided in an embodiment of the present application;

[0037] Fig.26 It is a schematic diagram of the structure of a driver provided in an embodiment of the present application;

[0038] Fig. 27 It is a schematic diagram of the structure of a driver including a cutting hose provided in an embodiment of the present application;

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

[0040] Fig.29 It is a structural schematic diagram of the cooperation between an anchor assembly and a sleeve provided in an embodiment of the present application;

[0041] Fig.30 It is a schematic diagram of the completion of leaflet suturing during artificial chord implantation provided in an embodiment of the present application;

[0042] Fig.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] Fig.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] Fig.33 It is a schematic diagram of the structure of an anchor assembly anchoring a target tissue provided by an embodiment of the present application;

[0045] Fig.34 It is a structural schematic diagram of a suture tensioning provided by an embodiment of the present application;

[0046] Fig.35 It is a structural schematic diagram of an actuating member actuating a wire pressing member to lock provided in an embodiment of the present application;

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

[0048] Fig.37 It is a schematic diagram of a structure in which a driver is released from an anchor assembly provided in an embodiment of the present application;

[0049] Fig.38 It is a structural schematic diagram of a conveying device withdrawal provided in an embodiment of the present application;

[0050] Fig.39 It is a structural schematic diagram of a wire cutting device provided in an embodiment of the present application;

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

[0052] Description of labels:

[0053] Anchor assembly-1, suture-2, anchoring member-10, spiral coil-11, connecting member-12, locking wire assembly-20, main body-21, guide sliding surface-211, main body-212, end plate-213, support part-214, second wire passage-215, guide part-216, positioning end-2161, protrusion-217, accommodating channel-218, guide hole-219, wire pressing member-22, self-locking section-221, rotating part-222, driving part-223, wire pressing part-224 , the first wire-passing channel - 225, the retaining member - 23, the self-locking bevel - 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 cutting device - 83. DETAILED DESCRIPTION

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

[0055] Reference to "embodiment" or "implementation" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiment or implementation may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood 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", etc. in the specification and claims of this application and the above drawings are used to distinguish different objects rather than to describe a specific order. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions.

[0057] In this specification, for the sake of convenience, the words and phrases indicating the orientation or positional relationship such as "middle", "upper", "lower", "front", "back", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like are used to illustrate the positional relationship of the constituent elements with reference to the drawings. This is only for the convenience of describing this specification and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation of the present disclosure. The positional relationship of the constituent elements is appropriately changed according to the orientation of the constituent elements being described. Therefore, it is not limited to the words and phrases described in the specification, and can be appropriately replaced according to the circumstances.

[0058] In this specification, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate, or the internal communication of two elements. For ordinary technicians in this field, the meanings of the above terms in this disclosure can be understood according to the 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 the 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 through 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 Fig. 22 and Fig.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 as to press the suture 2 between the main body 21 and the wire pressing member 22 onto the main body 21. The retaining member 23 is located between the main body 21 and the wire pressing member 22, and the retaining member 23 is configured to keep the wire pressing member 22 in the position of squeezing the suture 2. Specifically, the retaining member 23 abuts between the main body 21 and the wire pressing member 22 and can be displaced under the drive of the wire pressing member 22, such as elastically displacing under the action of elastic force until it abuts and supports the wire pressing member 22, so that the wire pressing member 22 can continue to squeeze the suture 2, thereby keeping the suture 2 in a locked state. Of course, the retaining member 23 can also be displaced between the main body 21 and the wire 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 10, and then actuate the wire pressing piece 22 to move relative to the main body 21 to the wire 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 wire locking state of the wire pressing piece 22, so as to resist the risk of loosening of the suture 2 due to continuous heart beating, which helps to 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 wire pressing member 22 is rotatably connected to the main body 21, and the rotation axis of the wire pressing member 22 is fixed relative to the position of the main body 21. The end of the wire 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 wire 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 wire pressing member 22 has a self-locking section 221 (i.e., the arc-shaped outer surface of the middle end of the wire 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 from the abutting position (such as the first end position A) of the self-locking section 221 abutting against the retaining member 23 to 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 body 21 in a direction away from the retaining member 23, the self-locking section 221 can be driven to rotate relative to the main body 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 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 that abuts against the retaining member 23 to the guide surface 211.

[0063] In contrast, the retaining member 23 has a self-locking inclined surface 231 (i.e., an 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 an elastic thrust, so that the self-locking inclined surface 231 of the retaining member 23 is always abutted against 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 a 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 can be understood that, please refer to Figure 4 and Figure 5 When the self-locking section 221 abuts against the first position C of the self-locking inclined surface 231, 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 second position D of the self-locking inclined surface 231, 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 curvature radius. Further, the self-locking segment 221 is an arc-shaped outer surface with a gradually decreasing curvature radius from the first end position A to the second end position B, and 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 wire pressing piece 22 in the wire locking state, the wire pressing piece 22 has a tendency to reverse in the direction close to the self-locking inclined surface 231. However, 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 wire pressing piece 22 with a reversal tendency will produce a greater squeezing force on the retaining piece 23. 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 is continuously in contact with the second end position B of the self-locking segment 221, and to prevent the wire 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 wire 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 part 222 is roughly cylindrical, and the thread pressing part 224 is convexly arranged at one end of the cylindrical surface of the rotating part 222, so as to cooperate with the main body 21 to press the suture 2; the driving part 223 is convexly arranged at the other end of the cylindrical surface of the rotating part 222, so as to be removably engaged with the actuating member 40. At this time, the thread pressing part 224 and the driving part 223 that drives the thread pressing part 224 to rotate can be effectively isolated by the main body 21, thereby ensuring that the suture 2 and the actuating member 40 that actuates the driving part 223 to move are isolated from each other, avoiding the problem of mutual interference between the two due to being too close.

[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 against 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 against 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 an engagement end, and the distal end of the actuator 40 is removably engaged to the engagement end. Therefore, 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 rod bodies that are convexly arranged side by side on the rotating portion 222 and are spaced apart, and form a accommodating space with the engagement end. Among them, 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 using a connecting structure, and the above-mentioned connecting structure is described in detail later.

[0070] Specifically, the joint end may include a winding shaft having a smooth outer surface, which extends or is connected between the two rods and is disposed away from the wire pressing portion 224. Fig. 22As shown, the actuator 40 is a flexible traction member, which can realize the removable engagement of the two by winding the distal end back to the winding shaft; wherein the flexible traction member can be, for example, a metal wire such as stainless steel wire, nickel titanium wire, tungsten wire, etc., can be a metal rope such as stainless steel wire rope, tungsten wire rope, nickel titanium wire rope, etc., can also be a polymer rope or line such as PET medical line, PTFE rope or ultra-high molecular weight polyethylene medical line. It can be understood that the winding shaft can have a closed cross-section of various shapes such as square, circular, polygonal, etc. In order to enable the actuator 40 to be smoothly withdrawn from the winding shaft, the present application preferably has a circular cross-section. The rod body can be a straight rod or a curved rod, and the curved rod can strengthen the bending stress of the rod body to reduce the risk of the rod body breaking. Of course, in order to further avoid the risk of the flexible traction member detaching from the outer surface of the winding shaft and causing the actuation failure, in some embodiments, the joint end also includes a protrusion, which is arranged on the side of the rod body adjacent to the winding shaft to prevent the flexible traction member from detaching from the winding shaft from the distal end of the rod body when it is in a loose state. Alternatively, the joint end further includes a traction hole, and two traction holes are provided on the winding shaft and axially penetrate the outer surface thereof, and the distal end of the flexible traction member is looped around and penetrated in the two traction holes in an open loop. Alternatively, the diameter of the winding shaft can be set to gradually increase from the middle to both ends, so as to keep the flexible traction member in the middle position of the winding shaft for a long time as much as possible. Alternatively, the joint end further includes an anti-slip shaft, which is arranged between the two rod bodies 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 wire pressing portion 224, so that the wire pressing member 22 can form a labor-saving mechanism, which is more conducive to driving the wire pressing member 22 to achieve thread locking. For example, the length of the wire pressing portion 224 is L1, and the pressing force required for the wire pressing portion 224 to press 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 actuating member 40 is F2. Based on the lever principle, at this time, the relationship between the four should satisfy the formula F1*L1=F2*L2. Therefore, when L2>L1, the wire 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 passing through the first thread passing channel 225, the suture 2 is located between the main body 21 and the thread pressing portion 224, and can move toward the main body 21 driven by 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 suture 2 can be restricted along the axial movement of the main body 21, 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 212 of a substantially rectangular parallelepiped structure, an end plate 213 connected to one end of the main body 212 close to the retaining member 23, and a pair of supporting portions 214 connected to the outer peripheral wall of the end plate 213 and extending along the length direction of the main body 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 one 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 and distributed on opposite sides of the width direction of the main body 212, and each support portion 214 exceeds the guide sliding surface 211 of the main body 212. 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 arranged in the receiving space.

[0074] In one embodiment of the present application, a first through hole is provided at one end of each support portion 214 away from the end plate 213 along the width direction of the main body 212, a second through hole is provided at the rotating portion 222 of the wire pressing member 22, and the anchor assembly 1 further comprises 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 a 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 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 supporting portions 214, so that the wire pressing member 22 is rotatably connected to the pair of supporting portions 214 of the main body 21 around the pair of connecting shafts, thereby eliminating the connecting shafts 24 of a separate component and simplifying the structure of the anchor assembly 1. Of course, in other embodiments, each supporting portion 214 may also be provided with a connecting shaft protruding toward the other supporting portion 214, and the two connecting shafts of a pair of supporting portions 214 are installed in the second through holes of the wire pressing member 22, so that the wire pressing member 22 can be rotatably connected to the pair of supporting portions 214 of the main body 21 around the pair of connecting shafts, thereby eliminating 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 is radially extended from one end of the main body 21 away from the retaining member 23 and in a direction perpendicular to the guide sliding surface 211, and the guide portion 216 and the wire pressing portion 224 are located on the same side of the main body 21. The guide portion 216 is provided with a second wire passage 215, and the suture 2 axially passes through the connected second wire passage 215 and the first wire passage 225 and then passes through the anchor assembly 1. Specifically, the inner diameter of the second wire passage 215 is larger than the diameter of the suture 2 so that the suture 2 can move freely.

[0078] In this embodiment, by opening a second wire-passing channel 215 connected to the first wire-passing channel 225 on the guide portion 216 of the main body 21, the movement of the suture 2 along the radial direction of the main body 21 can be further restricted. At the same time, under the dual restrictions of the second wire-passing channel 215 and the first wire-passing channel 225, it can be ensured that part of the suture 2 is located between the main body 21 and the wire-pressing portion 224, and the wire-pressing portion 224 can be rotated to press the suture 2. Among them, the first wire-passing channel 225 and the second wire-passing channel 215 both include but are not limited to round holes, elliptical holes or other shapes of through 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 a thread pressing portion 224 of the thread pressing piece 22 is provided with a thread pressing surface matching 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 Fig. 9and Fig.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 part 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 generally U-shaped shape. Among them, the first bearing surface is a partial arc surface on the inner side of the guide portion 216, and extends generally 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 partial 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 generally in the axial direction. A protrusion 217 is further provided on the second bearing surface, and a gap is formed between the protrusion 217 and the guide portion 216 to accommodate at least part of the wire pressing portion 224. The third bearing surface is a surface on the protrusion 217 that is opposite to the first bearing surface and is connected to the second bearing surface. At the same time, the pressing surface is at least one end surface of the pressing part 224, including a first pressing surface matched with the first bearing surface, a second pressing surface matched with the second bearing surface, and a third pressing surface matched with the third bearing surface, so as to form a U-shaped pressing surface extending in a roughly U-shaped 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 an 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 roughly U-shaped locking length 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 leads to a larger axial dimension of the guide portion 216: and, when the wire pressing portion 224 presses the suture 2 to the bearing surface, if the acute angle is too small, it is easier 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 onto the first bearing surface by the first pressing surface and pressed onto 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 Figure 8-Figure 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 axially compressed between the push-up member 232 and the main body 21. The elastic member 233 is used to provide an 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: Fig.13 and Fig.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: Fig.16 The elastic single member shown.

[0083] Specifically, 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., the length direction of the main body 212), and the guide column 234 is at least partially received in the guide hole 219 and can move axially relative to the guide hole 219. Specifically, the guide column 234 is at least partially received 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 column 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 column 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 column 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, so that the retaining member 23 can be limited to not move 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 stability of the movement 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 sheet, 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, Fig.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-up member 232 and the end plate 213 of the main member 21 , and can also push the retaining member 23 .

[0085] Please refer to Fig.16 In another embodiment of the present application, the push piece 232 and the elastic piece 233 are integrally formed, the push piece 232 is a wedge-shaped block, and the elastic piece 233 is a columnar structure or a sheet structure protruding from one end of the wedge-shaped block away from the self-locking inclined surface 231. At least the axial part of the elastic piece 233 is elastic to achieve axial compression and extension. Among them, a guide groove is provided on the side of the end plate 213 facing the retaining member 23, and the elastic piece 233 always pushes against the guide groove to be axially elastically compressed to between the wire pressing piece 22 and the end plate 213.

[0086] Please refer to Fig.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 may include a spiral anchor or a barbed spring. The following description takes the anchor 10 as a spiral anchor, which should not be construed as a limitation on the present application.

[0087] Specifically, Fig.17 and Fig.18 As shown, the main body 21 is provided with an axially penetrating receiving channel 218 for rotational connection with the proximal end of the anchor 10. The anchor 10 includes a spiral coil 11 and a connecting member 12 provided at the proximal end of the spiral coil 11. The spiral coil 11 is located at the distal end of the main body 21 for engagement with the target tissue. The connecting member 12 is at least partially rotationally received in the receiving channel 218 and cannot be axially separated from the receiving channel 218.

[0088] The spiral coil 11 includes a spiral section with a sharp distal end for engaging with the target tissue and an axial connecting section formed by transitioning from the proximal end of the spiral section. The axial connecting section is coaxially arranged with the spiral section to ensure that the anchor 10 does not radially jump when anchored. The connecting member 12 is generally in the shape of a hollow tube, including a hollow inner cavity extending in the axial direction, for at least partially accommodating the axial connecting section of the spiral coil 11. Furthermore, an installation window connected to the accommodating channel 218 is provided at the side end of the accommodating channel 218, through which the anchor 10 can 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, and 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 at the installation window by laser welding. Of course, other methods such as soldering, brazing, and adhesives can also be used for fixing.

[0089] Continue reading Fig.17 and Fig.18 In order to ensure that the anchor 10 rotates circumferentially with the main body 21 after installation, the two can also remain axially relatively fixed and inseparable, the present application sets the accommodating channel 218 as a channel with at least two sections of radial size changes, including a proximal channel for accommodating at least part of the connecting member 12 and a distal channel for accommodating at least part of the axial connecting section. Among them, the proximal channel is connected with the distal channel to form the accommodating channel 218; and the diameter of the proximal channel is greater than the diameter of the distal channel, and its axial length is also greater than the axial length of the distal channel. At this time, the middle axial connecting section between the spiral section and the connecting member 12 is accommodated in the distal channel, and the spiral sections and the connecting member 12 with larger radial dimensions on both sides axially restrict the middle axial connecting section with smaller diameter in the distal channel, so as to achieve the axial inseparability of the anchor 10 relative to the main body 21. In some embodiments, the cross-sectional shape of the accommodating channel 218 is a circular stepped structure, so that the anchor 10 can rotate relative to the main body 21.

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

[0091] Please refer to Fig.17 and Fig.18In one embodiment of the present application, in order to avoid the wear 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 part 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 part 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 part 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-passing channel 225 and / or the surface of the second wire-passing channel 215, or a coating or a flexible member covering the surface of the first wire-passing channel 225 and / or the surface of the second wire-passing channel 215. The hardness of the coating, coating and flexible member is lower than that of the main body 21 and the wire pressing member 22. Therefore, by providing the coating, coating or flexible member to contact the suture 2, it is possible to avoid the suture 2 from directly contacting the first wire-passing channel 225 of the main body 21 and the second wire-passing channel 215 of the wire pressing member 22 and causing wear and other phenomena.

[0093] In this embodiment, the flexible member is a cloth sleeve, which is a tubular body with a certain wall thickness and has an inner cavity for passing the suture 2. Optionally, the cloth sleeve includes but is not limited to being fixed to the surface of the first wire passage 225 or the second wire passage 215 by adhesive bonding or suturing; and the cloth sleeve includes but is not limited to a PET braided tube or other polymer materials with similar material properties to the suture 2, and the wall thickness of the cloth sleeve 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 covered to the surface of the first wire passage 225 and / or the surface of the second wire passage 215 by winding.

[0094] Please refer to Fig.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 in conjunction with the accompanying drawings.

[0095] Please refer to Fig. 20 and Fig.21In one embodiment of the present application, the delivery device includes, from the inside to the outside, an actuator 40, a driver 50, a positioning needle 60, an outer tube assembly 70, and a handle assembly 82 at the proximal end. 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, and the inner cavity of the tube assembly 70 is also used to pass the suture 2. The anchor assembly 1 is pre-loaded at 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 inserted in the buffer 30.

[0096] Please refer to Fig. 22 and Fig.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 Fig. 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 controls the proximal handle assembly 82 to release any one or both free ends of the actuator 40, and pulls it away along one of the free ends to realize the release of the actuator 40 from the driving part 223 of the wire pressing member 22.

[0098] Optionally, see Fig.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 driving portion 223 may be a threaded connection, that is, one end of the actuator 40 is threadedly connected to the driving portion 223, and the other end is connected to the proximal handle assembly 82. When the locking line is completed, the operator operates the proximal handle assembly 82 to rotate the actuator 40 so that the actuator 40 rotates relative to the driving portion 223 to achieve thread release, thereby achieving relative release between the actuator 40 and the driving portion 223.

[0099] Please refer to Fig.24 and Fig.25The proximal end of the connector 12 is provided with a joint portion for removably engaging with the driver 50, and the driver 50 can drive the anchor 10 to rotate relative to the lock wire assembly 20. Specifically, the driver 50 includes a drive shaft 51 and a release rod 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, and the mating portion cooperates with the joint portion to realize the detachable connection between the connector 12 and the drive shaft 51. Optionally, the connection and cooperation mode of the mating portion and the joint portion includes but is not limited to an S-shaped connection.

[0100] Furthermore, the release rod 52 is located in the hollow tube of the drive shaft 51 and can move and rotate axially along the hollow tube. When the release rod 52 is in the connection position between the matching part and the joint part, the drive shaft 51 can be used to drive the connector 12 and the anchor assembly 1 to move together to achieve the implantation of the anchor assembly 1. After the release rod 52 is pulled out of the connection position between the matching part and the joint part, the matching part and the joint part can move relative to each other, so that the drive shaft 51 can be radially displaced relative to the connector 12, and then the drive shaft 51 and the release rod 52 are moved out of the body to achieve the release of the driver 50.

[0101] Specifically, 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. Fig.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 a better torque transmission efficiency than the cutting tube. In other embodiments, such as Fig. 27 As shown, the drive shaft 51 can be an integrated cutting hose, and a plurality of cutting sections are cut at the distal end of the cutting hose to form the flexible section 511 of the drive shaft 51 .

[0102] Please refer to Fig.28 and Fig.29The tube body assembly 70 includes a sleeve 71 at the distal end and a flexible tube body 72 extending 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 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 suture 2 is squeezed, a positioning end 2161 with an increased width is provided at one 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 the sleeve 71 is required to have a certain support strength to provide the support force required for the wire locking process. Optionally, the material of the sleeve 71 includes but is not limited to polymer materials, stainless steel or other hard materials, and this application does not limit this. Optionally, the sleeve 71 and the flexible tube body 72 are connected in a manner including but not limited to gluing or 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 Fig.30 As shown, a suturing device (not shown) is delivered through a delivery sheath 81 to fix the distal end of the suture 2 inside it 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 through the delivery sheath 81 to the outside of the body.

[0106] The second step is, Fig.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, wherein in this embodiment, the target tissue area is near the papillary muscle in the ventricle.

[0107] The third step is Fig.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 (manually axially pushed or driven by the control handle assembly 82) 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, thereby preventing the anchoring position from being inconsistent with the target position.

[0108] The fourth step is Fig.33 As shown, the handle assembly 82 of the conveying device is controlled or manually screwed to actuate the driver 50 to screw forward to the distal end, thereby driving the anchor assembly 1 to screw forward to the distal end as a whole, thereby rotating the anchor 10 to be embedded in the papillary muscle; at this time, the anchor 10 is screwed forward to the distal end, and the locking wire assembly 20 moves axially to the distal end 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 to the inside of the flexible tube body 72.

[0109] Step 5: Fig.34 and Fig.35 As shown, a certain pulling force is applied to the proximal end of the external suture 2 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 to 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 to actuate the wire pressing member 22 to rotate around the connecting shaft 24 to a wire locking state of compressing the suture 2 to complete the wire locking.

[0110] Step 6: Fig.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. Fig.37 and Fig.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: Fig.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. Fig.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, so as to repair the heart valve.

[0112] It can be understood 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 annular contraction and ventricular reconstruction to repair heart function.

[0113] The above are some 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 on a target tissue, characterized in that: include: an anchor for engaging the target tissue; as well as A wire locking assembly, the wire locking assembly comprising: a main body member connected to the proximal end of the anchor member; A thread pressing member, the thread pressing member is movably connected to the main body, the suture is passed through the main body and the thread pressing member, and the thread pressing member can be actuated to move relative to the main body and press the suture; and 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.

2. The anchor assembly according to claim 1, characterized in that: 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. 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.

3. The anchor assembly according to claim 2, characterized in that: 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 an elastic displacement to slide toward the wire pressing member.

4. The anchor assembly according to claim 3, characterized in that: 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.

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

6. The anchor assembly according to claim 4, characterized in that: The included angle α between the self-locking inclined surface and the guide sliding surface satisfies: α≤45 degrees.

7. The anchor assembly according to claim 4, characterized in that: The retaining member comprises a push-up member and an elastic member, the self-locking inclined surface is arranged on the push-up member, and the elastic member is arranged on a side of the push-up member away from the wire pressing member and is axially compressed between the push-up member and the main body member.

8. The anchor assembly according to claim 7, 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.

9. The anchor assembly according to claim 2, characterized in that: The wire pressing member 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 actuating member to drive the wire pressing part and the self-locking section to rotate.

10. The anchor assembly according to claim 9, 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.

11. The anchor assembly according to claim 10, characterized in that: 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.

12. The anchor assembly according to claim 11, characterized in that 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 coating or a flexible component covering the surface of the first wire passing channel and / or the surface of the second wire passing channel.

13. The anchor assembly according to claim 1, characterized in that The main body is provided with an axially extending accommodation channel, the anchoring member includes a spiral coil and a connecting member arranged 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 rotatably accommodated in the accommodation channel.

14. The anchor assembly according to claim 13, characterized in that The proximal end of the connecting member is provided with an engaging portion for removably engaging with a driver, and the driver can drive the anchor member to rotate relative to the locking wire assembly.

15. The anchor assembly according to claim 2, characterized in that 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.

Images