Anchors, Anchor Delivery Devices, Implants, and Repair Systems

Abstract

The present invention belongs to the field of interventional medical devices. The present invention provides an anchor. The anchor includes a main body, a connector and a connecting rod mechanism. The main body includes a guide rod and a tip element. The connector is movably mounted on the guide rod. The connecting rod mechanism includes a first connecting rod and a second connecting rod that are rotatably connected to each other. The first connecting rod is rotatably connected to the connector. The second connecting rod is rotatably connected to the tip element. The connector is configured to move axially along the guide rod to drive the connecting rod mechanism to radially expand or retract. The anchor is configured to remain in an expanded state after being implanted into tissue. The present invention also provides an anchor delivery device, an implant and a repair system.

Description

Technical Field

[0001] The present invention belongs to the field of interventional medical devices and relates to cardiac interventional treatment devices, in particular to an anchor, an anchor delivery device, an implant and a repair system. Background Art

[0002] Mitral regurgitation is a common heart valve disease, encompassing both primary and secondary mitral regurgitation. Primary mitral regurgitation is caused by mitral valve leaflet abnormalities, chordae tendineae rupture, or papillary muscle insufficiency, leading to poor anastomosis between the anterior and posterior mitral leaflets. Secondary mitral regurgitation is caused by annular dilatation and left atrial and ventricular enlargement, leading to poor anastomosis between the anterior and posterior mitral leaflets. Traditionally, treatment for secondary mitral regurgitation involves surgical repair with the insertion of an annuloplasty ring. However, this procedure is invasive and associated with poor postoperative recovery, making it unsuitable for elderly patients. Due to its minimally invasive and safe nature, interventional mitral valve treatment has rapidly developed in recent years, primarily encompassing valve repair or valve replacement. Annuloplasty is a common repair procedure, involving the implantation of several anchors connected in series via sutures into the mitral or tricuspid annulus. By reducing the spacing between the anchors, the annulus is reduced in size, thereby alleviating regurgitation.

[0003] In existing transcatheter annuloplasty procedures, the majority of anchors are helical. Helical anchors require rotational movement to enter the tissue, making operation cumbersome. Furthermore, helical anchors can become entangled with sutures during rotation, leading to annuloplasty failure. Summary of the Invention

[0004] The object of the present invention is to provide an anchor, an anchor delivery device, an implant and a repair system.

[0005] The present invention provides an anchor. The anchor includes a main body, a connector, and a connecting rod mechanism. The main body includes a guide rod and a tip element connected to the guide rod. The connector is movably mounted on the guide rod. The connecting rod mechanism includes a first connecting rod and a second connecting rod that are rotatably connected to each other. The first connecting rod is rotatably connected to the connector. The second connecting rod is rotatably connected to the tip element. The connector is configured to move axially along the guide rod to drive the connecting rod mechanism to radially expand or retract. The anchor is configured to remain in an expanded state after being implanted into tissue.

[0006] In some embodiments, the connector is provided with a connection hole configured to allow the flexible elongated member to pass through.

[0007] In some embodiments, the connector includes a connector and a connecting structure connected to the connector. The connector is movably mounted on the guide rod. The first connecting rod is rotatably connected to the connector. The connecting structure defines the connecting hole.

[0008] In some embodiments, the connecting member includes a first connecting member and a second connecting member. The first connecting member is provided with a first through hole extending axially along the guide rod. The second connecting member is provided with a second through hole extending axially along the guide rod. The guide rod is movably inserted into the first through hole and the second through hole. The connecting structure is located between the first connecting member and the second connecting member.

[0009] In some embodiments, one of the first and second connectors includes a connecting tube, and the other includes a connecting groove. The connecting groove communicates with the first through-hole or the second through-hole. The first and second connectors are fixedly connected by the coupling of the connecting tube and the connecting groove. The connecting structure is movably mounted on the connecting tube.

[0010] In some embodiments, the radial dimension of the connecting groove is larger than the diameter of the first through hole or the second through hole, thereby forming a stepped surface. The axial dimension of the connecting tube is larger than the axial dimension of the connecting groove. The connecting tube is inserted into the connecting groove and abuts against the stepped surface. The connecting structure is sleeved over the portion of the connecting tube exposed in the connecting groove.

[0011] In some embodiments, the second connecting rod includes a tip portion and a connecting portion connected to the tip portion. The first connecting rod is provided with a receiving groove. The tip portion is rotatably connected to the first connecting rod. The receiving groove is configured to receive the tip portion.

[0012] In some embodiments, the tip element is provided with a first receiving groove, the connecting portion is rotatably received in the first receiving groove, and the rotation axis of the connecting portion relative to the tip element is parallel to the rotation axis between the first connecting rod and the second connecting rod.

[0013] In some embodiments, the connecting member is provided with a second accommodating groove corresponding to the first accommodating groove. The first connecting rod is rotatably accommodated in the second accommodating groove. The rotation axis of the first connecting rod relative to the connecting member is parallel to the rotation axis between the first connecting rod and the second connecting rod.

[0014] In some embodiments, the outer peripheral wall of the guide rod is provided with a relief position along its axial direction. The relief position is provided on the same side of the guide rod as the first accommodating groove and the second accommodating groove. The relief position is configured to retract the connecting rod mechanism.

[0015] In some embodiments, the connector is further provided with a positioning groove, and the guide rod is provided with a positioning portion, and the positioning portion is configured to cooperate with the positioning groove to limit the proximal movement of the connector relative to the guide rod.

[0016] In some embodiments, the guide rod has an inner cavity along its axial direction. A window communicating with the inner cavity is formed on an outer peripheral wall of the guide rod. The positioning portion is elastic and is disposed in the window.

[0017] In some embodiments, the outer peripheral wall of the guide rod is further provided with a stopper, the stopper being closer to the tip element than the positioning portion, and the stopper being configured to stop the connector to limit distal movement of the connector relative to the guide rod.

[0018] In some embodiments, the anchor comprises at least two linkage mechanisms, and the at least two linkage mechanisms are spaced apart around the circumference of the guide rod.

[0019] The present invention also provides an anchor delivery device. The anchor delivery device includes a delivery assembly and an anchor. The delivery assembly includes a delivery sheath and a connecting rod movably disposed within the delivery sheath. The anchor's connector includes a first joint, and the delivery sheath includes a second joint, which is detachably connected to the first joint. The connecting rod is detachably connected to the guide rod. The connecting rod is configured to maintain the connection between the connector and the delivery sheath.

[0020] The present invention also provides an implant comprising a plurality of anchors, a flexible elongated member, and a locking mechanism. The flexible elongated members are connected to corresponding anchors via connection holes in the anchors. The flexible elongated members are configured to adjust the spacing between the plurality of anchors. The locking mechanism is configured to lock the length of the flexible elongated member to maintain tension in the flexible elongated member.

[0021] In some embodiments, the implant further comprises at least one spacer, wherein the spacer is movably connected to the flexible elongated member and is disposed between two adjacent anchors.

[0022] The present invention also provides a repair system comprising an implant and a delivery member, wherein the distal end of the delivery member is connected to the proximal end of a flexible elongated member of the implant, and the plurality of anchors and a locking device of the implant are delivered to the flexible elongated member along the delivery member.

[0023] In the anchor, anchor delivery device, implant and repair system of the present invention, the main body of the anchor has a tip element that is easy to penetrate into the tissue, and the anchor can be anchored into the tissue by pushing the anchor through the delivery assembly. In addition, since the anchor is provided with a connecting rod mechanism, the driving connector can drive the connecting rod mechanism to expand or retract by moving the driving connector along the axial direction of the guide rod. In order to facilitate delivery, before the anchor is implanted, the anchor is generally in a retracted state, that is, the connecting rod mechanism is retracted into a basically straight line. After the distal portion of the anchor in the retracted state enters the tissue (at this time, the first connecting rod portion enters the tissue), the driving connector moves distally relative to the guide rod to cause the connecting rod mechanism to gradually expand radially and penetrate into the tissue, and the anchor remains in the expanded state, thereby enhancing the anchoring force of the anchor. When the anchor is implanted, it only needs to be moved distally without rotation, and the operation is simple and convenient. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0025] Figure 1 It is a schematic diagram of the three-dimensional structure of an anchor provided by one embodiment of the present invention in an expanded state.

[0026] Figure 2 yes Figure 1 Schematic diagram of the three-dimensional structure of the anchor in the retracted state.

[0027] Figure 3 yes Figure 1 Schematic diagram of the structure of the connection between the anchor nail and the flexible slender member.

[0028] Figure 4 yes Figure 1 Schematic diagram of the three-dimensional structure of the anchor.

[0029] Figure 5 yes Figure 1 Schematic diagram of the three-dimensional structure of the connector.

[0030] Figure 6 yes Figure 5 Cross-sectional view of the connector along line AA.

[0031] Figure 7 yes Figure 5 Schematic diagram of the three-dimensional structure of the connector.

[0032] Figure 8 yes Figure 1 Schematic diagram of the three-dimensional structure of the subject.

[0033] Figure 9 yes Figure 8 Schematic diagram of the three-dimensional structure decomposition of the subject.

[0034] Figure 10 yes Figure 1 Schematic diagram of the three-dimensional structure of the connecting rod mechanism.

[0035] Figure 11 yes Figure 10 Schematic diagram of the three-dimensional structure decomposition of the connecting rod mechanism.

[0036] Figure 12 It is a schematic diagram of the three-dimensional structure of a second connecting rod provided in another embodiment of the present invention.

[0037] Figure 13 It is a schematic diagram of the three-dimensional structure of a second connecting rod provided in another embodiment of the present invention.

[0038] Figure 14 It is a schematic diagram of the three-dimensional structure of an anchor provided by another embodiment of the present invention in a retracted state.

[0039] Figure 15 yes Figure 14 Schematic diagram of the three-dimensional structure of the anchor in the expanded state.

[0040] Figure 16 yes Figure 14 Schematic diagram of the three-dimensional structure of the guide rod.

[0041] Figure 17 yes Figure 14 Schematic diagram of the scenario in which the anchor is implanted into the tissue.

[0042] Figure 18 It is a schematic structural diagram of an anchor provided by another embodiment of the present invention.

[0043] Figure 19 yes Figure 18 Schematic diagram of the three-dimensional structure of the connection structure.

[0044] Figure 20 yes Figure 18 Schematic diagram of the three-dimensional structure of the connection between the anchor nail and the flexible slender member.

[0045] Figure 21 It is a schematic structural diagram of an anchor provided by another embodiment of the present invention.

[0046] Figure 22 yes Figure 21 Schematic diagram of the three-dimensional structure of the connection structure.

[0047] Figure 23 yes Figure 21 Schematic diagram of the three-dimensional structure of the connection between the anchor nail and the flexible slender member.

[0048] Figure 24 It is a schematic diagram of the three-dimensional structure of a connection structure provided by another embodiment of the present invention.

[0049] Figure 25 It is a structural schematic diagram of an anchor delivery device provided in one embodiment of the present invention.

[0050] Figure 26 yes Figure 25 Schematic diagram of the structural decomposition of the anchor delivery device.

[0051] Figure 27 Schematic diagram of the structure of an implant provided by one embodiment of the present invention.

[0052] Figure 28 FIG. 1 is a schematic structural diagram of an implant provided in another embodiment of the present invention.

[0053] Figure 29 It is a structural diagram of a repair system provided in one embodiment of the present invention.

[0054] Figure 30 It is a partial cross-sectional view of a repair system provided by another embodiment of the present invention.

[0055] Figure 31 FIG1 is a schematic diagram of a surgical path for applying a repair system provided by one embodiment of the present invention to mitral valve annuloplasty.

[0056] Figure 32 This is a schematic diagram of the process of implanting one of the anchors into the tissue.

[0057] Figures 33 to 36 Schematic diagram of the procedure for implanting the mitral valve annulus. DETAILED DESCRIPTION

[0058] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0059] The following descriptions of the embodiments are provided with reference to the accompanying drawings to illustrate specific embodiments in which the present invention may be practiced. Directional terms used herein, such as "top," "bottom," "front," "back," "left," "right," "inside," "outside," and "side," are used solely with reference to the directions in the accompanying drawings. Therefore, the use of directional terms is intended to better and more clearly illustrate and understand the present invention, and is not intended to indicate or imply that the device or component referred to must have, be constructed, or operate in a specific orientation, and should not be construed as limiting the present invention.

[0060] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated and limited, the terms "installed", "connected", "connected", and "set on..." 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; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be internal communication between two components.

[0061] In the field of interventional medical devices, the proximal end of a medical device refers to the end closest to the operator, while the distal end refers to the end farther from the operator. Axial refers to the direction of the device's central axis, radial refers to the direction perpendicular to the axial direction and containing the radius or diameter, and circumferential refers to the direction perpendicular to and surrounding the axial direction. Those skilled in the art will understand the specific meanings of these terms in this disclosure based on specific circumstances.

[0062] In the present invention, the terms "first," "second," and "third" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the quantity of the technical features indicated. Therefore, a feature specified as "first," "second," or "third" may explicitly or implicitly include one or more of the features.

[0063] See also Figure 1 and Figure 2 An embodiment of the present invention provides an anchor 100. The anchor 100 includes a main body 10, a connector 20, and a connecting rod mechanism 30. The main body 10 includes a guide rod 12 and a tip element 14 connected to the guide rod 12. The connector 20 is movably mounted on the guide rod 12. The connecting rod mechanism 30 includes a first connecting rod 32 and a second connecting rod 34 that are rotatably connected to each other. The first connecting rod 32 is rotatably connected to the connector 20. The second connecting rod 34 is rotatably connected to the tip element 14. The connector 20 is configured to move along the axial direction of the guide rod 12 to drive the connecting rod mechanism 30 to expand or retract. The anchor 100 is configured to remain in an expanded state after being implanted into tissue.

[0064] The main body 10 of the anchor 100 of the present invention includes a pointed element 14 that facilitates tissue penetration. The anchor 100 is pushed by the delivery assembly to anchor the anchor 100 into the tissue. Furthermore, because the anchor 100 includes a linkage mechanism 30, the axial movement of the drive connector 20 along the guide rod 12 can cause the linkage mechanism 30 to expand or collapse. To facilitate delivery, prior to implantation, the anchor 100 is typically in a collapsed state, with the linkage mechanism 30 collapsed into a substantially straight line. After the distal end of the collapsed anchor 100 enters the tissue (at which point the first linkage 32 partially enters the tissue), the drive connector 20 moves distally relative to the guide rod 12, causing the linkage mechanism 30 to gradually expand radially and penetrate the tissue. The anchor 100 remains in the expanded state, enhancing its anchoring force. Implantation of the anchor 100 requires only distal movement, without the need for rotation, making operation simple and convenient.

[0065] Specifically, the first link 32 and the second link 34 are rotatably connected. The proximal end of the first link 32 is rotatably connected to the connector 20, and the distal end of the second link 34 is rotatably connected to the tip element 14. When the linkage mechanism 30 is in the deployed state, the connector 20 is driven to move proximally relative to the guide rod 12, and the connector 20 pulls the first link 32 proximally. The first link 32 drives the second link 34 to rotate relative to the tip element 14, so that the first and second links 32, 34 gradually approach the guide rod 12, thereby causing the linkage mechanism 30 to enter the collapsed state. During delivery of the anchor 100, the linkage mechanism 30 remains collapsed, and the delivery assembly pushes the anchor 100, causing the tip element 14 to penetrate the tissue until the linkage mechanism 30 partially enters the tissue. Then, the connector 20 is driven to move distally relative to the guide rod 12, pushing the first connecting rod 32 distally. The first connecting rod 32 drives the second connecting rod 34 to rotate relative to the tip element 14, so that the first connecting rod 32 and the second connecting rod 34 gradually move away from the guide rod 12, thereby allowing the link mechanism 30 to be deployed and penetrate the tissue, thereby enhancing the anchoring force of the anchor 100. It should be noted that when the link mechanism 30 is retracted, the anchor 100 is in the retracted state; when the link mechanism 30 is deployed, the anchor 100 is in the deployed state.

[0066] The anchor 100 may be made of, but not limited to, 316L stainless steel, cobalt-chromium alloy, titanium or nickel-titanium alloy, and has good biocompatibility.

[0067] In some embodiments, see Figure 3, the connector 20 is provided with a connecting hole 201. The connecting hole 201 is constructed to allow the flexible elongated member 310 to pass through. It can be understood that the anchor 100 is connected to the flexible elongated member 310 through the connecting hole 201. In this way, a number of anchors 100 connected in series through the flexible elongated member 310 can be implanted in the mitral valve annulus or the tricuspid valve annulus, and the spacing between the anchors 100 can be reduced by tightening the flexible elongated member 310 to reduce the patient's valve annulus size and thereby reduce or eliminate blood reflux. Of course, the flexible elongated member 310 connected to the anchor 100 can also be used as an artificial tendon and fixed in the heart through the anchor 100. It should be noted that since the anchor 100 only needs to move distally during implantation and does not need to rotate, there will be no entanglement between the anchor 100 and the flexible elongated member 310.

[0068] The flexible elongated member 310 can be a flexible linear object, such as a thread, filament, strip, ribbon, or rope. The radial cross-section of the flexible elongated member 310 can be circular, oblate, rectangular, square, or other shapes. The flexible elongated member 310 can be made of a metal material and / or a polymer material, preferably a biocompatible material, such as 316L stainless steel, tungsten, tantalum, nickel titanium, polyethylene, polyamide, polypropylene, or polyurethane. Exemplarily, the flexible elongated member 310 is a slender wire, such as a metal wire.

[0069] In some embodiments, see Figures 1 to 3 The connector 20 includes a connector 21 and a connecting structure 23 connected to the connector 21. The connector 21 is movably mounted on the guide rod 12. The first connecting rod 32 is rotatably connected to the connector 21. The connecting structure 23 defines a connecting hole 201. Thus, the connecting hole 201 is provided in the connecting structure 23 connected to the connector 21.

[0070] exist Figures 1 to 3 In the example, the connecting structure 23 can be movably mounted on the connecting member 21. The connecting structure 23 can rotate relative to the connecting member 21. When multiple anchors 100 are implanted in the valve annulus to adjust the size of the valve annulus, the flexible elongated member 310 connected to the connecting hole 201 of the connecting structure 23 can pull the connecting structure 23 to rotate relative to the connecting member 21 and the main body 10, so that the connecting hole 201 of each anchor 100 is basically arranged along the circumference of the valve annulus. In other examples, the connecting structure 23 is fixed to the outer peripheral wall of the connecting member 21. In other embodiments, the connecting hole 201 can be directly provided on the connecting member 21.

[0071] In some embodiments, see Figures 4 to 7The connecting member 21 includes a first connecting member 212 and a second connecting member 214. The first connecting member 212 defines a first through hole 2121 extending axially along the guide rod 12. The second connecting member 214 defines a second through hole 2141 extending axially along the guide rod 12. The guide rod 12 is movably inserted into the first through hole 2121 and the second through hole 2141. The connecting structure 23 is located between the first connecting member 212 and the second connecting member 214.

[0072] Optionally, the connecting structure 23 can be movably mounted on the first connecting member 212 or the second connecting member 214. Specifically, one of the first connecting member 212 and the second connecting member 214 includes a connecting tube, and the other includes a connecting groove. The connecting groove communicates with the first through-hole 2121 or the second through-hole 2141. The first connecting member 212 and the second connecting member 214 are fixedly connected through the mating of the connecting tube and the connecting groove. The connecting structure 23 can be movably mounted on the connecting tube. This allows the connecting structure to rotate relative to the connecting tube. The connecting tube can be fixedly connected to the connecting groove by, but not limited to, welding, clamping, or gluing.

[0073] exist Figures 4 to 7 In the example, the first connecting member 212 includes a connecting tube 2122, the barrel cavity of which forms part of the first through-hole 2121. The second connecting member 214 is provided with a connecting groove 2142, which is arranged along the edge of the second through-hole 2141 and communicates with the second through-hole 2141. The radial dimension ID1 of the connecting groove 2142 is greater than the aperture ID2 of the second through-hole 2141, forming a step surface 2143. The axial dimension L1 of the connecting tube 2122 is greater than the axial dimension L2 of the connecting groove 2142. The connecting tube 2122 is inserted into the connecting groove 2142 and abuts against the step surface 2143. The connecting structure 23 is sleeved over the portion of the connecting tube 2122 exposed in the connecting groove 2142. Specifically, the connecting structure 23 includes an annular member 232, which is movably sleeved over the portion of the connecting tube 2122 exposed in the connecting groove 2142. The annular member 232 is rotatable relative to the connecting tube 2122. It will be appreciated that the provision of the stepped surface 2143 limits the length of the connecting tube 2122 that can be inserted into the connecting groove 2142. It should be noted that the axial dimension L2 of the connecting groove 2142 refers to the axial distance from the proximal end surface of the second connecting member 214 to the stepped surface 2143. The first connecting member 212, the second connecting member 214, and the connecting structure 23 can be machined from, but not limited to, 316L stainless steel, cobalt-chromium alloy, titanium, and other materials.

[0074] When assembling the connector 20, the annular member 232 of the connecting structure 23 is first inserted into the connecting tube 2122 of the first connecting member 212. The connecting tube 2122 is then inserted into the connecting groove 2142 of the second connecting member 214 and abutted against the stepped surface 2143. The first and second connecting members 212 and 214 are then secured by welding. In some examples, the outer diameter OD1 of the connecting tube 2122 is slightly smaller than the inner diameter ID3 of the annular member 232 of the connecting structure 23, meaning that the connecting tube 2122 can pass through the annular member 232. The inner diameter ID3 of the annular member 232 can be equal to the radial dimension ID1 of the connecting groove 2142. Furthermore, the difference between the axial dimension L1 of the connecting tube 2122 and the axial dimension L2 of the connecting groove 2142 is slightly greater than the axial dimension L3 of the annular member 232. After the connector 20 is assembled, the radial clearance between the annular member 232 and the connecting tube 2122 ranges from 0.03mm to 0.08mm, i.e., 0.03mm≤ID3-OD1≤0.08mm. The sum of the axial clearances between the annular member 232 and the first and second connecting members 212, 214 ranges from 0.03mm to 0.08mm, i.e., 0.03mm≤L1-L2-L3≤0.08mm. Because the annular member 232 of the connecting structure 23 has radial clearance relative to the connecting tube 2122 and axial clearance relative to the first and second connecting members 212, 214, the connecting structure 23 can rotate circumferentially relative to the connecting tube 2122. In other examples, the axial gap between the annular member 232 of the connecting structure 23 and the first connecting member 212 and the second connecting member 214 is larger, and the annular member 232 can also move axially along the connecting tube 2122, that is, the connecting structure 23 can both rotate circumferentially relative to the connecting tube 2122 and move axially relative to the connecting tube 2122.

[0075] In other examples, the first connector 212 is provided with a connecting groove, which is arranged along the edge of the first through hole 2121 and communicates with the first through hole 2121. The second connector 214 includes a connecting tube, the barrel cavity of which forms a portion of the second through hole 2141. The radial dimension of the connecting groove is larger than the aperture of the first through hole 2121, forming a stepped surface. The connecting tube can be inserted into the connecting groove and abut against the stepped surface. The connecting structure 23 is movably mounted on the portion of the connecting tube exposed in the connecting groove.

[0076] The following describes the specific structure of the anchor 100 in detail by taking the first connecting member 212 including the connecting tube 2122 and the second connecting member 214 having the connecting groove 2142 as an example.

[0077] In some embodiments, see Figure 8 and Figure 9The distal end surface of the tip element 14 is inclined proximally relative to its axial direction. The inclination angle A1 of the distal end surface of the tip element 14 relative to the axial direction is in the range of 15° ≤ A1 ≤ 40°, facilitating penetration of the tip element 14 into tissue. The tip element 14 can be machined from, but is not limited to, 316L stainless steel, cobalt-chromium alloy, titanium, or nickel-titanium alloy.

[0078] The tip element 14 is provided with an inner hole 143, and the guide rod 12 is inserted into the inner hole 143 of the tip element 14 and fixed. The aperture ID4 of the inner hole 143 of the tip element 14 is slightly larger than the outer diameter OD2 of the guide rod 12, and the gap between the two can range from 0.02mm to 0.06mm, that is, 0.02mm≤ID4-OD2≤0.06mm. The fitting clearance between the inner hole 143 of the tip element 14 and the guide rod 12 is small. When the guide rod 12 is inserted into the tip element 14, the deviation between the central axis of the guide rod 12 and the center line of the inner hole 143 of the tip element 14 can be avoided, so that the guide rod 12 is conveniently fixedly connected to the tip element 14 after being installed. The guide rod 12 and the tip element 14 can be fixedly connected by, but not limited to, welding, clamping or gluing.

[0079] See also Figures 6 to 8 When the connector 21 includes a first connector 212 and a second connector 214, after the first connector 212 and the second connector 214 are fixedly connected, the first through hole 2121 and the second through hole 2141 are connected. The aperture ID2 of the second through hole 2141 and the aperture ID5 of the first through hole 2121 are both larger than the outer diameter OD2 of the guide rod 12, where 0.05 mm ≤ ID2 - OD2 ≤ 0.15 mm, and 0.05 mm ≤ ID5 - OD2 ≤ 0.15 mm. The aperture ID5 of the first through hole 2121 can be equal to the aperture ID2 of the second through hole 2141. Since the axial movement distance of the first connecting member 212 and the second connecting member 214 along the guide rod 12 is large, the fitting clearance between the first through hole 2121 and the second through hole 2141 and the guide rod 12 is large, which facilitates the connecting head 20 to move smoothly along the axial direction of the guide rod 12 toward the distal end, so that the connecting rod mechanism 30 can be expanded, avoiding jamming of the connecting head 20 when moving along the axial direction of the guide rod 12.

[0080] In some embodiments, see Figure 4 、 Figure 10 and Figure 11The second connecting rod 34 includes a tip portion 341 and a connecting portion 343 connected to the tip portion 341. The first connecting rod 32 is provided with a receiving groove 321. The tip portion 341 is rotatably connected to the first connecting rod 32. The receiving groove 321 is configured to receive the tip portion 341. In this way, when the first connecting rod 32 drives the second connecting rod 34 to rotate so that the link mechanism 30 is in the retracted state, the tip portion 341 is received in the receiving groove 321. When the anchor 100 enters the tissue, the link mechanism 30 is in the retracted state. When the first connecting rod 32 drives the second connecting rod 34 to rotate so that the link mechanism 30 moves in the tissue during radial expansion, the tip portion 341 leaves the receiving groove 321, and the tip portion 341 is easily inserted into the tissue and pushed away, so that the link mechanism 30 is in the expanded state.

[0081] Specifically, a needle tip 3411 is provided at one end of the tip portion 341 away from the connecting portion 343. The radial dimension of the needle tip 3411 gradually decreases from the distal end to the proximal end. The angle A2 of the needle tip 3411 can be in the range of 15°≤A2≤40°. Figure 10 and Figure 11 In the example of FIG. 3 , the needle tip 3411 includes two opposing inclined surfaces. Angle A2 of the needle tip 3411 is the angle between the two inclined surfaces of the needle tip 3411 .

[0082] exist Figure 12 In the example of , the needle tip of the second connecting rod 34 can be multi-faceted sharpened. Figure 13 In the example of FIG, the needle tip of the second connecting rod 34 can be sharpened circumferentially. Like this, the ability of the tip portion of the second connecting rod 34 to penetrate into the tissue can be further improved.

[0083] In some embodiments, the first connecting rod 32 is provided with a receiving groove 321 to form two opposite side branches 3211. One end of the two side branches 3211 is respectively provided with a first mounting hole 323. Connecting studs 3413 are fixed on both sides of the tip 341 of the second connecting rod 34, and the connecting studs 3413 are arranged away from the needle tip 3411. By applying force, the two side branches 3211 of the first connecting rod 32 can be opened so that the connecting studs 3413 enter the first mounting hole 323. The connecting studs 3413 and the first mounting hole 323 are clearance-fitted. The tip 341 of the second connecting rod 34 is clearance-fitted with the receiving groove 321. After assembly is completed, the connecting studs 3413 are rotatably arranged in the first mounting hole 323. The first connecting rod 32 and the second connecting rod 34 can rotate relative to each other with the connecting studs 3413 as the rotation axis. Due to the relative rotation of the first connecting rod 32 and the second connecting rod 34 , the tip portion 341 of the first connecting rod 32 can be received in the receiving groove 321 or be separated from the receiving groove 321 .

[0084] In other embodiments, the connecting column head 3413 can be replaced with the first connecting rod. The tip portion 341 of the second connecting rod 34 is provided with a second mounting hole. When the tip portion 341 of the second connecting rod 34 is placed in the receiving groove 321 of the first connecting rod 32, the first mounting hole 323 and the second mounting hole are opposite each other, and the first connecting rod is inserted into the first mounting hole 323 and the second mounting hole, and the first connecting rod and the first connecting rod 32 are fixed by welding or gluing. The first connecting rod is loosely matched with the first mounting hole and the second mounting hole, making it easy for the first connecting rod to be inserted into the first mounting hole 323 and the second mounting hole. The tip portion 341 of the second connecting rod 34 is loosely matched with the receiving groove 321. After assembly is completed, the first connecting rod is relatively fixed to the first mounting hole 323, and the first connecting rod is rotationally matched with the second mounting hole. The first connecting rod 32 and the second connecting rod 34 can rotate relative to each other with the first connecting rod as the rotation axis. Of course, the first connecting rod and the second connecting rod 34 may also be fixed by welding or gluing, the first connecting rod and the second mounting hole are relatively fixed, and the first connecting rod and the first mounting hole 323 are rotatably matched.

[0085] In some embodiments, see Figure 4 The tip element 14 is provided with a first receiving groove 145. The connecting portion 343 of the second connecting rod 34 is rotatably received in the first receiving groove 145. The connecting portion 343 is parallel to the rotation axis between the first connecting rod 32 and the second connecting rod 34 relative to the rotation axis of the tip element 14.

[0086] Specifically, a first receiving groove 145 is provided at the proximal end of the tip element 14 of the main body 10. The first receiving groove 145 is connected to the inner hole 143. The tip element 14 is provided with third mounting holes 146 on opposite sides of the first receiving groove 145. A fourth mounting hole 344 is provided at the end of the connecting portion 343 away from the tip portion 341 (i.e., the distal end of the second connecting rod 34). The fourth mounting hole 344 passes through the connecting portion 343 of the second connecting rod 34 in a direction parallel to the rotation axis between the first connecting rod 32 and the second connecting rod 34. The linkage mechanism 30 also includes a second connecting rod 346. When the distal end of the second connecting rod 34 is placed in the first receiving groove 145, the third mounting hole 146 and the fourth mounting hole 344 are opposite each other. The second connecting rod 346 is inserted into the third mounting hole 146 and the fourth mounting hole 344, and the second connecting rod 346 and the tip element 14 are fixed by welding or gluing. The second connecting rod 346 is loosely fitted with the third mounting hole 146 and the fourth mounting hole 344, making it easier for the second connecting rod 346 to be inserted into the third mounting hole 146 and the fourth mounting hole 344. The distal end of the second connecting rod 34 is loosely fitted with the first accommodating groove 145. After assembly, the second connecting rod 346 is relatively fixed to the third mounting hole 146, and the second connecting rod 346 is rotationally engaged with the fourth mounting hole 146. The second connecting rod 34 can rotate relative to the tip element 14 with the second connecting rod 346 as the rotation axis, and the distal end of the second connecting rod 34 can rotate within the first accommodating groove 145. Of course, the second connecting rod 346 and the connecting portion 343 of the second connecting rod 34 can also be fixed by welding or gluing, with the second connecting rod 346 being relatively fixed to the fourth mounting hole 344 and the second connecting rod 346 being rotationally engaged with the third mounting hole 146.

[0087] Furthermore, the connecting member 21 is provided with a second accommodating groove 215 corresponding to the first accommodating groove 145. The first connecting rod 32 is rotatably accommodated in the second accommodating groove 215. The rotation axis of the first connecting rod 32 relative to the connecting member 21 is parallel to the rotation axis between the first connecting rod 32 and the second connecting rod 34.

[0088] Specifically, the distal end of the connector 21 is provided with a second accommodating groove 215. The first accommodating groove 145 and the second accommodating groove 215 are provided on the same side of the guide rod 12 to facilitate the axial movement of the connector 20 along the guide rod 12 to pull the first connecting rod 32 and drive the second connecting rod 34 to rotate.

[0089] When the connecting member 21 includes a first connecting member 212 and a second connecting member 214, the second receiving groove 215 is disposed at the distal end of the second connecting member 214. The second receiving groove 215 communicates with the second through-hole 2141. The second connecting member 214 is provided with fifth mounting holes 2152 on opposite sides of the second receiving groove 215. A sixth mounting hole 324 is provided at the end of the first connecting rod 32 distal from the receiving groove 321 (i.e., the proximal end of the first connecting rod 32). The sixth mounting hole 324 extends through the first connecting rod 32 in a direction parallel to the rotation axis between the first connecting rod 32 and the second connecting rod 34. The connecting rod mechanism 30 also includes a third connecting rod 326. When the proximal end of the first connecting rod 32 is placed in the second receiving groove 215, the fifth mounting hole 2152 and the sixth mounting hole 324 are aligned. The third connecting rod 326 is inserted into the fifth mounting hole 2152 and the sixth mounting hole 324, and is secured to the second connecting member 214 by welding or gluing. The third connecting rod 326 is loosely fitted with the fifth mounting hole 2152 and the sixth mounting hole 324, making it easier for the third connecting rod 326 to be inserted into the fifth mounting hole 2152 and the sixth mounting hole 324. The proximal end of the first connecting rod 32 is loosely fitted with the second accommodating groove 215. After assembly is complete, the third connecting rod 326 is relatively fixed to the fifth mounting hole 2152, and the second connecting rod 346 is rotationally engaged with the sixth mounting hole 324. The first connecting rod 32 can rotate relative to the second connecting member 214 with the third connecting rod 326 as the rotation axis, and the proximal end of the first connecting rod 32 can rotate within the second accommodating groove 215. Of course, the second and third connecting rods 326 and the first connecting rod 32 can also be fixed by welding or gluing, with the third connecting rod 326 being relatively fixed to the sixth mounting hole 324 and the second connecting rod 346 rotationally engaged with the fifth mounting hole 2152.

[0090] In the present invention, the first connecting rod 32 and the second connecting rod 34 can be machined from, but not limited to, 316L stainless steel, cobalt-chromium alloy, or nickel-titanium alloy. The first connecting rod 346, the second connecting rod 326, and the third connecting rod 326 can be made from, but not limited to, 316L stainless steel, cobalt-chromium alloy, titanium, or other materials.

[0091] In some embodiments, see Figure 4 、 Figure 8 and Figure 9The outer peripheral wall of the guide rod 12 is provided with an avoidance position 123 along its axial direction. The avoidance position 123 and the first accommodating groove 145 and the second accommodating groove 215 are provided on the same side of the guide rod 12. The avoidance position 123 is configured to retract the connecting rod mechanism 30. It can be understood that when the connector 20 moves proximally along the axial direction of the guide rod 12, the connecting rod mechanism 30 continuously approaches the avoidance position 123 of the guide rod 12 until it is in contact with the avoidance position 123, and the tip 341 of the second connecting rod 34 is retracted into the receiving groove 321 of the first connecting rod 32, and the anchor 100 is in a retracted state. By providing the avoidance position 123, interference between the guide rod 12 and the first connecting rod 32 and the second connecting rod 34 can be avoided.

[0092] In some embodiments, see Figures 4 to 9 The connector 21 is further provided with a positioning groove 216. The guide rod 12 is provided with a positioning portion 125. The positioning portion 125 is configured to cooperate with the positioning groove 216 to limit the proximal movement of the connector 20 relative to the guide rod 12 (i.e., to limit the movement of the connector 20 relative to the guide rod 12 in a direction away from the tip element 14). In this way, the link mechanism 30 can be maintained in an expanded state. After the anchor 100 is implanted in the tissue, due to the cooperation between the positioning portion 125 and the positioning groove 216, even if the anchor 100 is subjected to a radial force of the tissue (a force perpendicular to the axial direction of the anchor 100), the radially expanded link mechanism 30 will not straighten back, thereby maintaining the link mechanism 30 in the expanded state, further improving the anchoring force of the anchor 100. When the connector 21 includes a first connector 212 and a second connector 214, the positioning groove 216 is provided in the second connector 214, and the positioning groove 216 is connected to the second through hole 2141.

[0093] Furthermore, the guide rod 12 has an inner cavity 126 along its axial direction. The guide rod 12 is provided with a window 127 connected to the inner cavity 126. The positioning portion 125 is elastic. The positioning portion 125 is provided in the window 127. It can be understood that the positioning portion 125 is provided corresponding to the position where the window 127 is provided on the guide rod 12. When the connecting head 20 moves toward the distal end along the axial direction of the guide rod 12, the second connecting member 214 pulls the first connecting rod 32 to drive the second connecting rod 34 to move in the radial direction. During the movement of the connecting head 20, the positioning portion 125 is subjected to radial compression by the connecting member 21 (the second connecting member 214), and the positioning portion 125 moves from the window 127 to the inner cavity 126 of the guide rod 12, and the positioning portion 125 is temporarily accommodated in the inner cavity 126 of the guide rod 12. As connector 20 continues to move distally, and positioning groove 216 of connector 21 faces window 127, positioning portion 125 is no longer squeezed by connector 21. Positioning portion 125 snaps into positioning groove 216, restricting proximal movement of connector 20 relative to guide rod 12 and maintaining linkage 30 in its deployed state. Guide rod 12 can be entirely constructed of nickel-titanium alloy, with positioning portion 125 formed by laser cutting window 127 and then heat-setting. Guide rod 12 can also be constructed of other biocompatible materials, as long as positioning portion 125 is elastic.

[0094] like Figure 5 、 Figure 7 and Figure 9 As shown, the width T1 of the positioning portion 125 satisfies 0.30mm≤T1≤0.60mm. The width T1 of the positioning portion 125 refers to the distance between the two opposite sides of the positioning portion 125 along the radial direction of the guide rod 12. The angle A3 between the positioning portion 125 and the outer peripheral wall of the guide rod 12 can be in the range of 25°≤A3≤45°. In this way, it is ensured that the positioning portion 125 abuts against the bottom surface of the positioning groove 216 after entering the positioning groove 216, and the positioning portion 125 can limit the movement of the connector 20 toward the proximal end, thereby maintaining the expanded state of the connecting rod mechanism 30. The guide rod 12 sets the outer diameter OD3 of the positioning portion 125 ≤ the outer diameter OD4 of the second connecting member 214 to ensure that when the connecting rod mechanism 30 is in the retracted state, the outer diameter difference of the anchor 100 is small, which facilitates the anchor 100 to penetrate into the tissue.

[0095] exist Figures 4 to 7 In the example shown, the second connecting member 214 is provided with two spaced-apart positioning slots 216, and the guide rod 12 is correspondingly provided with two spaced-apart positioning portions 125. The two positioning portions 125 respectively engage with the two positioning slots 216. Optionally, the two positioning slots 216 are symmetrically distributed about the central axis of the second connecting member 214, and the two positioning portions 125 are symmetrically distributed about the central axis of the guide rod 12. In other embodiments, other numbers of positioning slots 216 and positioning portions 125 may be provided based on actual usage requirements.

[0096] In some embodiments, see Figures 14 to 17 The outer peripheral wall of the guide rod 12 is further provided with a limiter 128. The limiter 128 is closer to the tip element 14 than the positioning portion 125. The limiter 128 is configured to stop the connector 21 to limit the distal movement of the connector 20 relative to the guide rod 12 (i.e., limit the movement of the connector 20 relative to the guide rod 12 toward the tip element 14). Figure 14 The collapsed state shown is transformed into Figure 15 During the unfolded state shown, the connector 20 moves distally until the second connector 214 contacts the limiter 128, and the second connector 214 cannot move distally beyond the limiter 128. Therefore, excessive distal movement of the connector 20, which may cause abnormal morphology of the anchor 100, can be avoided. Adding the limiter 128 can increase the stability of the anchor 100. In addition, when the anchor 100 is implanted in tissue, the limiter 128 can also limit the depth of the anchor 100 implanted in the tissue. When the anchor 100 is implanted in the position of the limiter 128, the limiter 128 and the tissue come into contact with each other, and there is resistance between the two. This resistance can prevent the anchor 100 from being implanted further, thereby controlling the depth of the anchor 100 implanted in the tissue and preventing the linkage mechanism 30 from over-expanding, which may affect the implantation effect of the anchor 100.

[0097] It will be appreciated that the positioning portion 125 cooperates with the positioning slot 216 of the second connector 214 to limit proximal movement of the connector 20 relative to the guide rod 12, thereby maintaining the linkage mechanism 30 in the deployed state after the anchor 100 is implanted in the tissue. The stopper 128 limits distal movement of the connector 20 relative to the guide rod 12, preventing excessive deployment of the linkage mechanism 30 and potentially affecting the implantation of the anchor 100.

[0098] Specifically, the stopper 128 is a stopper block protruding from the outer peripheral wall of the guide rod 12. The number of stoppers can be one, two, three, four, or more. When there are two or more stoppers, the stoppers can be evenly spaced along the circumference of the guide rod. Of course, the spacing between the stoppers can also be uneven. The stopper 128 can also be an annular block protruding from the outer peripheral wall of the guide rod 12.

[0099] In some embodiments, see Figures 4 to 7 The connecting structure 23 includes an annular member 232 and a boss 234 fixedly connected to the annular member 232. The connecting hole 201 is formed in the boss 234. The flexible elongated member 310 passes through the connecting hole 201 of the boss and is connected to the anchor 100.

[0100] In some embodiments, see Figures 18 to 20The connecting structure 23 includes an annular member 232 and a collar 235 movably connected to the annular member 232. Specifically, the annular member 232 includes a connecting ring 2321 and a protrusion 2323 fixedly connected to the connecting ring 2321. The protrusion 2323 has a mounting hole, and the collar 235 is movably inserted into the mounting hole to be movably connected to the annular member 232. The collar 235 defines a connecting hole 201. The flexible elongated member 310 passes through the connecting hole 201 of the collar 235 and is connected to the anchor 100. Because the mounting hole of the protrusion 2323 passes through the protrusion 2323 in the radial direction of the anchor 100, the collar 235 can rotate around the mounting hole to bring the collar 235 closer to the first connecting member 212 or the second connecting member 214, thereby reducing the outer diameter of the connecting structure 23.

[0101] In some embodiments, see Figures 21 to 23 The connecting structure 23 includes an annular member 232 and a collar 235 movably connected to the annular member 232. Specifically, the annular member 232 is a connecting ring. The connecting ring defines a mounting hole, and the collar 235 is movably inserted into the mounting hole to movably connect with the connecting ring. The collar 235 defines a connecting hole 201. The flexible elongated member 310 passes through the connecting hole 201 of the collar 235 and is connected to the anchor 100. Because the mounting hole of the connecting ring passes through the connecting ring in the radial direction of the anchor 100, the collar 235 can rotate about the mounting hole to bring the collar 235 closer to the first connecting member 212 or the second connecting member 214, thereby reducing the outer diameter of the connecting structure 23.

[0102] See also Figure 24 Alternatively, the connection structure 23 may include only a connection ring 2321, which defines a connection hole 201. The connection hole 201 passes through the connection ring 2321 in the radial direction of the anchor 100. The flexible elongated member 310 passes through the connection hole 201 of the connection ring 2321 and is connected to the anchor 100.

[0103] In some embodiments, the anchor 100 includes at least two linkage mechanisms 30. The at least two linkage mechanisms 30 are spaced apart around the circumference of the guide rod 12. Specifically, the anchor 100 may be provided with two to eight linkage mechanisms 30. Alternatively, if the anchor 100 includes two linkage mechanisms 30, the two linkage mechanisms 30 are spaced apart around the circumference of the guide rod 12 and symmetrically arranged about the central axis of the guide rod 12. Alternatively, if the anchor 100 includes three to eight linkage mechanisms 30, the plurality of linkage mechanisms 30 are spaced evenly around the circumference of the guide rod 12. Alternatively, the at least two linkage mechanisms 30 are spaced apart around the circumference of the guide rod 12, and the spacing may be unequal.

[0104] exist Figure 1 and Figure 2In the example shown, the anchor 100 has two linkage mechanisms 30, symmetrically arranged about the central axis of the guide rod 12. The second receiving grooves 215 of the second connector 214, the first receiving grooves 145 of the tip element 14, and the corresponding structures, such as the avoidance position 123, should be set to two. The avoidance position 123, the first receiving groove 145, and the second receiving groove 215 should correspond one-to-one, with the avoidance position 123, the first receiving groove 145, and the second receiving groove 215 being located on the same side of the guide rod 12.

[0105] exist Figure 14 and Figure 15 In the example shown, the anchor 100 preferably has four linkage mechanisms 30, which are evenly spaced around the circumference of the guide rod 12. The number of second receiving grooves 215 of the second connector 214, the number of first receiving grooves 145 of the tip element 14, the number of corresponding structures such as the avoidance position 123, and the number of corresponding structures should be set to four. The avoidance position 123, the first receiving groove 145, and the second receiving groove 215 correspond one-to-one, and the avoidance position 123, the first receiving groove 145, and the second receiving groove 215 are located on the same side of the guide rod 12. The positioning portion 125 is positioned away from the avoidance position 123 so that the linkage mechanism 30 does not affect the outer diameter of the anchor 100 when retracted.

[0106] See also Figure 4 、 Figure 25 and Figure 26 An embodiment of the present invention further provides an anchor delivery device 200. The anchor delivery device 200 includes a delivery assembly 220 and an anchor 100. The delivery assembly 220 includes a delivery sheath 221 and a connecting rod 223 movably disposed in the delivery sheath 221. The connector 20 is provided with a first joint 202, and the delivery sheath 221 is provided with a second joint 2212. The first joint 202 and the second joint 2212 are detachably connected. The connecting rod 223 is detachably connected to the guide rod 12. The connecting rod 223 is configured to maintain the connection between the connector 20 and the delivery sheath 221.

[0107] It will be appreciated that after the first joint 202 and the second joint 2212 of the connector 20 are connected, the connecting rod 223, which is disposed in the delivery sheath 221, passes through the junction of the first and second joints 202, 2212 and connects to the guide rod 12, thereby maintaining the connection between the connector 20 of the anchor 100 and the delivery sheath 221. After the anchor 100 is assembled with the delivery assembly 220, the delivery sheath 221 and the connecting rod 223 are simultaneously pushed to implant the anchor 100 into the tissue. When the distal end of the anchor 100, in the collapsed state, enters the tissue (at this point, the first connecting rod 32 partially enters the tissue), the delivery sheath 221 pushes the connector 20 of the anchor 100 distally relative to the connecting rod 223, moving it toward the distal end of the guide rod 12 (i.e., the delivery sheath 221 moves distally alone, while the connecting rod 223 does not move), causing the linkage mechanism 30 to gradually expand radially within the tissue. The anchor 100 can remain deployed within the tissue. Specifically, the anchor 100 engages with the positioning groove 216 of the connector 21 via the positioning portion 125, thereby maintaining the linkage 30 in place. To release the anchor 100, simply disconnect the connecting rod 223 from the guide rod 12 and retract the connecting rod 223, allowing the connecting rod 223 to evacuate the junction between the first joint 202 and the second joint 2212. This allows the delivery sheath 221 to be separated from the connector 20.

[0108] It should be noted that, when the connector 21 includes a first connector 212 and a second connector 214, the first engaging portion 202 is provided on the first connector 212. For example, when the first connector 212 includes a connecting tube 2122 and the second connector 214 has a connecting groove 2142, the first engaging portion 202 is connected to the proximal end of the connecting tube 2122.

[0109] In some embodiments, the first joint 202 and the second joint 2212 can be complementary S-shaped buckles. After the two S-shaped buckles are buckled together, they form an inner cavity, and the connecting rod 223 inserted into the delivery sheath 221 can keep the connector 20 connected to the delivery sheath 221. The connecting rod 223 is withdrawn from the joint of the two S-shaped buckles, and the delivery sheath 221 can be separated from the connector 20. In other embodiments, one of the first joint 202 and the second joint 2212 is a connecting buckle, and the other is provided with a buckling groove adapted to the connecting buckle. After the connecting buckle is buckled with the buckling groove, the connecting rod 223 can also pass through the joint of the connecting buckle and the buckling groove to keep the connector 20 connected to the delivery sheath 221.

[0110] In some embodiments, the connecting rod 223 is detachably connected to the guide rod 12 through the cooperation of a threaded structure. Specifically, one of the connecting rod 223 and the guide rod 12 is provided with a threaded column, and the other of the connecting rod 223 and the guide rod 12 is provided with a screw hole. The threaded column is screwed into the screw hole to form a detachable connection between the connecting rod 223 and the guide rod 12. In some examples, the distal end of the connecting rod 223 is provided with a threaded column 2232, and the proximal end of the guide rod 12 is provided with a screw hole 129, which is part of the inner cavity of the guide rod 12. In other examples, the distal end of the connecting rod 223 is provided with a screw hole, and the proximal end of the guide rod 12 is provided with a threaded column.

[0111] It will be appreciated that when releasing the anchor 100 from the distal end of the delivery assembly 220, the threaded connection between the connecting rod 223 and the guide rod 12 is first rotated to release the threaded connection, the connecting rod 223 is then withdrawn to remove the connecting rod 223 from the interface between the first engagement portion 202 and the second engagement portion 2212, and the delivery sheath 221 is then withdrawn to allow the second engagement portion 2212 to separate from the first engagement portion 202. Because the second engagement portion 2212 of the delivery sheath 221 and the first engagement portion 202 of the connector 20 are mutually restrained, when the connecting rod 223 rotates relative to the delivery sheath 221, the delivery sheath 221 can restrict the anchor 100 from rotating along with the connecting rod 223, thereby facilitating the separation of the threaded column from the screw hole.

[0112] See also Figure 4 and Figure 27 The present invention also provides an implant 300. The implant 300 includes a plurality of anchors 100, a flexible elongated member 310, and a lock 330. The flexible elongated member 310 is connected to a corresponding anchor 100 through the connection hole 201 of the anchor 100. The flexible elongated member 310 is configured to adjust the spacing between the plurality of anchors 100. The lock 330 is configured to lock the length of the flexible elongated member 310 to maintain tension in the flexible elongated member 310.

[0113] Multiple anchors 100 connected by a flexible, elongated member 310 can be implanted into cardiac tissue such as the mitral valve annulus, tricuspid valve annulus, left ventricular wall, or right ventricular wall. By pulling the flexible, elongated member 310, the multiple anchors 100 are brought closer together to reduce the annulus, thereby treating blood regurgitation. After the desired annulus reduction effect is achieved, the length of the flexible, elongated member 310 can be locked by a locker 330 to maintain the tension of the flexible, elongated member 310, thereby maintaining the effect of reducing the annulus. When the implant 300 is implanted in the annulus, the annulus is directly reduced by tightening the flexible, elongated member 310. When the implant 300 is implanted in the ventricular wall below the annulus, such as the ventricular wall 0.5-2 cm below the annulus, the purpose of reducing the annulus can also be achieved by tightening the flexible, elongated member 310 to narrow the ventricle and reduce its volume. It should be noted that reducing the volume of the left ventricle can also treat ischemic heart failure.

[0114] After the connecting structure 23 of the first anchor 100 implanted in the cardiac tissue is connected to the distal end of the flexible elongated member 310, the distal end of the flexible elongated member 310 can be fixed by a fixing member or by knotting, wrapping, welding, or bonding to ensure that the flexible elongated member 310 and the connecting structure 23 of the first anchor 100 cannot be separated and remain connected. The connecting structures 23 of the remaining anchors 100 anchored to the cardiac tissue can move along the flexible elongated member 310, or the flexible elongated member 310 can move through the connecting structures 23 of the remaining anchors 100.

[0115] See also Figure 28 The implant 300 further includes at least one spacer 350. The spacer 350 is movably connected to the flexible elongated member 310. The spacer 350 is disposed between two adjacent anchors 100. It will be appreciated that the spacer 350 can prevent the flexible elongated member 310 from being overtightened, resulting in the distance between the two adjacent anchors 100 being too short. Furthermore, the spacer 350 can act as a buffer, dispersing the tightening force applied to the anchors 100 and ensuring stable implantation of the anchors 100. The spacer 350 is a cylindrical member of a certain length, preferably made of a biocompatible material. The spacer 350 can be coated to reduce the risk of cardiac tissue being damaged by the spacer.

[0116] Optionally, a spacer 350 may be provided between any two adjacent anchors 100 among the plurality of anchors 100, i.e., the anchors 100 and the spacers 350 are staggered. Of course, a spacer 350 may also be provided every two or more anchors 100, i.e., a spacer 350 may be provided between some adjacent anchors 100, while no spacer 350 may be provided between some adjacent anchors 100. The present invention is not limited to this.

[0117] See also Figure 29 Embodiments of the present invention also provide a repair system 400. The repair system 400 includes an implant 300 and a delivery member 410. The distal end of the delivery member 410 is connected to the proximal end of the flexible, elongated member 310. Multiple anchors 100 and locks 330 are delivered to the flexible, elongated member 310 along the delivery member 410. It will be appreciated that the distal end of the flexible, elongated member 310 is connected to the first anchor 100. The flexible, elongated member 310 and the delivery member 410 are delivered into the patient's body along with the first anchor 100, with the proximal end of the delivery member 410 extending outside the body. In this way, the connecting structure of the anchor 100, the spacer 350, the lock 330, and the like can be attached to the flexible, elongated member 310 via the delivery member 410. This allows the flexible, elongated member 310 to be implanted at a suitable length, eliminating the need for in vivo trimming of the flexible, elongated member 310 and preventing particles from falling off the wire, making the surgery safer.

[0118] The transport member 410 can be a flexible, linear object, such as a thread, filament, strip, ribbon, or rope. The radial cross-section of the transport member 410 can be circular, oblate, rectangular, square, or other shapes. The transport member 410 can be made of a metal and / or a polymer material, preferably a biocompatible material such as 316L stainless steel, tungsten, tantalum, nickel titanium, polyethylene, polyamide, polypropylene, or polyurethane. Exemplarily, the transport member 410 is a long, thin wire, such as a polymer wire.

[0119] In some embodiments, the proximal end of the flexible elongated member 310 forms a U-shaped connection with the distal end of the transport member 410. The transport member 410 can be separated from the flexible elongated member 310 by pulling the transport member 410 outside the body, simplifying the process. In other embodiments, the transport member 410 can be detachably connected to the flexible elongated member 310 via a threaded connection, a snap-fit ​​connection, or other methods, which will not be described in detail.

[0120] In other embodiments, the repair system 400 can omit the delivery member 410. The flexible elongated member 310 is sufficiently long that, after the first anchor 100 enters the heart, the proximal end of the flexible elongated member 310 can extend outside the patient's body. In this manner, multiple anchors 100 can be implanted and the flexible elongated member 310 can be tightened to reduce the annulus. After the desired annulus reduction effect is achieved, the length of the flexible elongated member 310 can be locked using the lock 330 to maintain tension in the flexible elongated member 310, thereby maintaining the annular reduction effect. Excess portions of the flexible elongated member 310 can be trimmed using a wire cutter.

[0121] See also Figure 30 The repair system 400 also includes an outer sheath 430 and an inner sheath 450 that can be movably inserted into the outer sheath 430. The inner sheath 450 can extend from the distal end of the outer sheath 430 and be adjusted to the vicinity of the heart tissue. At least the distal portion of the delivery assembly 220 is flexible. After the anchor 100 is assembled with the delivery assembly 220, the delivery assembly 220 can deliver the anchor 100 into the heart in the inner sheath 450. Both the outer sheath 430 and the inner sheath 450 are adjustable bending sheaths, which facilitate adjustment of the degree of bending and direction of their distal portions, making it easy to adjust the inner sheath 450 to the vicinity of the heart tissue. The anchor 100 is in a retracted state during delivery, and the anchor 100 can be moved in the inner sheath 450 by being pushed by the delivery assembly 220.

[0122] Please also refer to Figures 31 to 36The following describes the use and working principle of the repair system 400 according to an embodiment of the present invention, using the repair system as an example for mitral annuloplasty. The surgical path is: femoral vein - inferior vena cava IVC - right atrium RA - atrial septum AS - left atrium LA - mitral valve annulus MVA. The distal end of the flexible elongated member 310 is connected to the first anchor 100, and the proximal end of the flexible elongated member 310 is U-shapedly connected to the distal end of the delivery member 410. The first anchor 100 is assembled with the delivery assembly 220 and loaded into the inner sheath 450.

[0123] Step 1: If Figure 31 As shown, the outer sheath 430 is guided into the left atrium LA through a conventional approach such as transseptal puncture via the femoral vein to establish a channel, and the inner sheath 450 extends from the distal end of the outer sheath 430 to the vicinity of the mitral valve annulus MVA.

[0124] Step 2: If Figure 32 As shown, first, the delivery assembly 220 and the anchor 100 are adjusted to a target position within the mitral valve annulus MVA via the inner sheath 450. Simultaneously, the delivery sheath 221 and the connecting rod 223 of the delivery assembly 220 are pushed distally, causing the tip element 14 of the anchor 100 to penetrate the tissue. When the positioning portion 125 of the anchor 100 approaches the tissue, the advancement of the delivery sheath 221 and the connecting rod 223 is stopped. Then, the delivery sheath 221 is pushed distally alone, and the connector 20 moves distally along the guide rod 12, driving the first connecting rod 32 and the second connecting rod 34 to gradually deploy within the tissue. The delivery sheath 221 continues to be pushed until the positioning portion 125 of the guide rod 12 engages the positioning slot 216 of the second connector 214, and the linkage 30 is fully deployed. Next, the connecting rod 223 is rotated relative to the delivery sheath 221 to release the connecting rod 223 from the guide rod 12 of the anchor 100, and the connecting rod 223 is withdrawn to separate from the joint of the first joint portion 202 and the second joint portion 2212. Finally, the delivery sheath 221 and the connecting rod 223 are withdrawn.

[0125] During the implantation of the anchor 100 , it is only necessary to push the delivery sheath 221 and the connecting rod 223 axially without rotating the delivery sheath 221 , which will prevent the anchor 100 from being entangled with the flexible elongated member 310 and the delivery member 410 .

[0126] Step 3: If Figure 33 As shown, the spacer 350 and the second anchor 100 assembled with the delivery assembly 220 are delivered to the flexible elongated member 310 along the delivery member 410. The delivery assembly 220 and the anchor 100 are adjusted to another target position of the mitral valve annulus MVA through the inner sheath 450, and the second anchor 100 is implanted in the second step.

[0127] Step 4: If Figure 34 and Figure 35As shown, a plurality of anchors 100 and a plurality of spacers 350 are implanted in the mitral valve annulus MVA as needed.

[0128] Step 5: If Figure 36 and Figure 28 As shown, first, the locker 330 is conveyed along the conveyor 410 onto the flexible elongated member 310. Then, the locker 330 is controlled to adjust the length of the flexible elongated member 310 on the annulus to reduce the spacing between the multiple anchors 100, thereby reducing the annulus. After achieving a satisfactory annular reduction effect, the locker 330 locks the length of the flexible elongated member 310 to maintain tension. It should be noted that the conveyor 410 can be withdrawn after the flexible elongated member 310 and the locker 330 are stably connected.

[0129] It is understood that the repair system 400 can also be applied to tricuspid annuloplasty, and its operation is similar to that of the mitral annuloplasty, which will not be described in detail here. It should be noted that the implant 300 may not include the spacer 350 .

[0130] It should be noted that, unless there is a conflict, the embodiments and features of the embodiments of the present invention may be combined with each other, and any combination of features from different embodiments is also within the scope of protection of the present invention. In other words, the multiple embodiments described above may also be combined arbitrarily according to actual needs.

[0131] It should be noted that all the above drawings are exemplary diagrams of the present invention and do not represent the actual size of the product. Moreover, the dimensional ratio relationship between the components in the drawings does not serve as a limitation on the actual product of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. The scope of protection of the present invention is not limited thereto. Any person skilled in the art who is familiar with the technical scope disclosed in the present invention can easily think of changes or replacements, which should be covered within the scope of protection of the present invention. In summary, the content of this specification should not be understood as a limitation on the present invention.

Claims

1. An anchor, characterized in that: The anchor comprises: a main body comprising a guide rod and a tip element connected to the guide rod; a connecting head, the connecting head being movably sleeved on the guide rod; and a connecting rod mechanism, the connecting rod mechanism comprising a first connecting rod and a second connecting rod rotatably connected to each other, the first connecting rod being rotatably connected to the connecting head, and the second connecting rod being rotatably connected to the tip element; The connector is configured to move along the axial direction of the guide rod to drive the link mechanism to expand or collapse, and the anchor is configured to remain in an expanded state after being implanted into tissue.

2. The anchor according to claim 1, characterized in that The connecting head is provided with a connecting hole, and the connecting hole is configured to allow the flexible elongated member to pass through.

3. The anchor according to claim 2, characterized in that The connecting head includes a connecting member and a connecting structure connected to the connecting member. The connecting member is movably sleeved on the guide rod. The first connecting rod is rotatably connected to the connecting member. The connecting structure defines the connecting hole.

4. The anchor according to claim 3, characterized in that The connecting member includes a first connecting member and a second connecting member, the first connecting member is provided with a first through hole extending along the axial direction of the guide rod, the second connecting member is provided with a second through hole extending along the axial direction of the guide rod, and the guide rod is movably inserted into the first through hole and the second through hole; The connecting structure is located between the first connecting member and the second connecting member.

5. The anchor according to claim 4, characterized in that One of the first connecting member and the second connecting member includes a connecting tube, and the other is provided with a connecting groove, which is connected to the first through hole or the second through hole. The first connecting member and the second connecting member are fixedly connected through the cooperation between the connecting tube and the connecting groove, and the connecting structure can be movably mounted on the connecting tube.

6. The anchor according to claim 5, characterized in that The radial dimension of the connecting groove is larger than the aperture of the first through hole or the aperture of the second through hole to form a step surface, the axial dimension of the connecting tube is larger than the axial dimension of the connecting groove, the connecting tube is inserted into the connecting groove and abuts against the step surface, and the connecting structure is sleeved on the portion of the connecting tube exposed in the connecting groove.

7. The anchor according to claim 3, characterized in that: The second connecting rod includes a tip portion and a connecting portion connected to the tip portion. The first connecting rod is provided with a receiving groove. The tip portion is rotatably connected to the first connecting rod. The receiving groove is configured to receive the tip portion.

8. The anchor according to claim 7, characterized in that The tip element is provided with a first accommodating groove, the connecting portion is rotatably accommodated in the first accommodating groove, and the rotation axis of the connecting portion relative to the tip element is parallel to the rotation axis between the first connecting rod and the second connecting rod.

9. The anchor according to claim 8, characterized in that The connecting member is provided with a second accommodating groove corresponding to the first accommodating groove, the first connecting rod is rotatably accommodated in the second accommodating groove, and the rotation axis of the first connecting rod relative to the connecting member is parallel to the rotation axis between the first connecting rod and the second connecting rod.

10. The anchor according to claim 9, characterized in that The outer peripheral wall of the guide rod is provided with an avoidance position along its axial direction. The avoidance position and the first accommodating groove and the second accommodating groove are provided on the same side of the guide rod. The avoidance position is configured to retract the connecting rod mechanism.

11. The anchor according to claim 3, characterized in that The connecting piece is further provided with a positioning groove, and the guide rod is provided with a positioning portion, which is configured to cooperate with the positioning groove to limit the movement of the connecting head toward the proximal end relative to the guide rod.

12. The anchor according to claim 11, characterized in that The guide rod has an inner cavity along its axial direction, and a window communicating with the inner cavity is opened on the guide rod. The positioning portion is elastic and is arranged on the window.

13. The anchor according to claim 11 or 12, characterized in that: The outer peripheral wall of the guide rod is further provided with a limiting piece, which is closer to the tip element than the positioning portion. The limiting piece is configured to stop the connecting piece to limit the distal movement of the connecting head relative to the guide rod.

14. The anchor according to claim 2, characterized in that The anchor includes at least two link mechanisms, and the at least two link mechanisms are spaced apart around the circumference of the guide rod.

15. An anchor delivery device, characterized in that: The anchor delivery device includes a delivery assembly and the anchor according to any one of claims 1 to 14; wherein, the delivery assembly includes a delivery sheath and a connecting rod movably arranged in the delivery sheath, the connecting head of the anchor is provided with a first joint portion, the delivery sheath is provided with a second joint portion, the second joint portion is detachably connected to the first joint portion, the connecting rod is detachably connected to the guide rod, and the connecting rod is constructed to maintain the connection between the connecting head and the delivery sheath.

16. An implant, characterized in that The implant comprises a plurality of anchors according to any one of claims 2 to 14, the flexible elongated member, and a locker, wherein the flexible elongated member is connected to the corresponding anchors through the connecting holes, the flexible elongated member is configured to adjust the spacing between the plurality of anchors, and the locker is configured to lock the length of the flexible elongated member to maintain the tension of the flexible elongated member.

17. The implant according to claim 16, characterized in that The implant further includes at least one spacer, which is movably connected to the flexible elongated member and is disposed between two adjacent anchors.

18. A repair system, characterized in that: The repair system comprises the implant according to claim 16 or 17 and a delivery member, wherein the distal end of the delivery member is connected to the proximal end of the flexible elongated member, and the plurality of anchors and the locker are delivered to the flexible elongated member along the delivery member.

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