Anchor, anchor delivery device, implant and repair system

Abstract

The invention belongs to the field of interventional medical instruments. The invention provides an anchor. The anchor comprises a main body, a connector and a connecting rod mechanism. The body includes a guide rod and a tip element. And the connector is movably arranged on the guide rod in a sleeving manner. The connecting rod mechanism comprises a first connecting rod and a second connecting rod which are rotationally connected with each other. The first connecting rod is rotationally connected to the connector. The second link is rotatably connected to the tip element. The connector is constructed to move in the axial direction of the guide rod so as to drive the connecting rod mechanism to be unfolded or folded in the radial direction. The anchor is configured to maintain an unfolded state after implantation into tissue. The 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 therapeutic devices, and 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, including primary mitral regurgitation and secondary mitral regurgitation. Primary mitral regurgitation is caused by abnormal mitral valve leaflets, ruptured chordae tendineae or papillary muscle insufficiency, resulting in poor anastomosis of the anterior and posterior leaflets of the mitral valve. Secondary mitral regurgitation is caused by valve ring dilatation, left atrial and left ventricular enlargement, resulting in poor anastomosis of the anterior and posterior leaflets of the mitral valve. For secondary mitral regurgitation, traditional treatment uses surgical thoracotomy to implant an artificial ring for valve repair, but thoracotomy is more harmful to patients and has poor postoperative recovery, which is not suitable for elderly patients. Due to the minimally invasive and safe nature of interventional treatment, mitral valve interventional treatment has developed rapidly in recent years, mainly including valve repair or valve replacement. Among them, annuloplasty is a common repair procedure, in which a number of anchors connected in series by sutures are implanted on the mitral valve ring or tricuspid valve ring, and the patient's valve ring size is reduced by reducing the distance between the anchors to achieve the purpose of reducing blood reflux.

[0003] In existing transcatheter annuloplasty, most anchors are spiral anchors. The spiral anchors need to be driven into the tissue by rotation, which is cumbersome to operate. In addition, the spiral anchors may get entangled with the sutures when rotating, resulting in failure of the annuloplasty. 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 comprises a main body, a connector and a connecting rod mechanism. The main body comprises a guide rod and a tip element connected to the guide rod. The connector is movably sleeved on the guide rod. The connecting rod mechanism comprises a first connecting rod and a second connecting rod 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 along the axial direction of 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 sleeved 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 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. 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 connecting member and the second connecting member includes a connecting tube, and the other is provided with a connecting groove. The connecting groove is connected to the first through hole or the second through hole. The first connecting member and the second connecting member are fixedly connected by the cooperation between the connecting tube and the connecting groove. The connecting structure can be movably sleeved on the connecting tube.

[0010] In some embodiments, 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. The connecting structure is sleeved on the portion of the connecting tube exposed in the connecting groove.

[0011] In some embodiments, the second connecting rod comprises 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 and the first accommodating groove and the second accommodating groove are provided on the same side of the guide rod. The relief position is configured to retract the connecting rod mechanism.

[0015] In some embodiments, the connector is further provided with a positioning groove. The guide rod is provided with a positioning portion. The positioning portion is configured to cooperate with the positioning groove to limit the connector from moving toward the proximal end relative to the guide rod.

[0016] In some embodiments, the guide rod has an inner cavity along its axial direction. The outer peripheral wall of the guide rod is provided with a window communicating with the inner cavity. The positioning portion is elastic and is arranged at the window.

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

[0018] In some embodiments, the anchor comprises at least two of the 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 inserted into the delivery sheath. The connecting head of the anchor is provided with a first joint portion, and the delivery sheath is provided with a second joint portion, and the second joint portion is detachably connected to the first joint portion. The connecting rod is detachably connected to the guide rod. The connecting rod is configured to maintain the connection between the connecting head and the delivery sheath.

[0020] The present invention also provides an implant, which comprises a plurality of anchors, a flexible elongated member and a locker. The flexible elongated member is connected to the corresponding anchors through the connecting holes of the anchors. The flexible elongated member is configured to adjust the spacing between the plurality of anchors. The locker is configured to lock the length of the flexible elongated member to maintain the tension of the flexible elongated member.

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

[0022] The present invention also provides a repair system, which includes an implant and a conveying member. The distal end of the conveying member is connected to the proximal end of the flexible elongated member of the implant. A plurality of anchors and a locking device of the implant are conveyed to the flexible elongated member along the conveying 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 collapse 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 collapsed state, that is, the connecting rod mechanism is collapsed into a basically straight line. After the distal end of the anchor in the collapsed state enters the tissue (at this time, the first connecting rod part enters the tissue), the driving connector moves distally relative to the guide rod so that the connecting rod mechanism gradually expands radially and penetrates into the tissue, and the anchor remains in an 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 solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying 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 in which the anchor is in a retracted state.

[0027] Figure 3 yes Figure 1 Schematic diagram of the structure in which the anchor is connected to the flexible slender member.

[0028] Figure 4 yes Figure 1 Schematic diagram of the three-dimensional structure decomposition 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 A 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] Fig. 9 yes Figure 8 Schematic diagram of the three-dimensional structure decomposition of the subject.

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

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

[0036] Fig.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] Fig.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] Fig.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] Fig.15 yes Fig.14 Schematic diagram of the three-dimensional structure in which the anchor is in an expanded state.

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

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

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

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

[0044] Fig. 20 yes Fig.18 Schematic diagram of the three-dimensional structure in which the anchor pin is connected to the flexible slender member.

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

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

[0047] Fig.23 yes Fig.21 Schematic diagram of the three-dimensional structure in which the anchor pin is connected to the flexible slender member.

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

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

[0050] Fig.26 yes Fig.25 Schematic diagram of the structural breakdown of the anchor delivery device.

[0051] Fig. 27 It is a schematic structural diagram of an implant provided in one embodiment of the present invention.

[0052] Fig.28 It is a schematic structural diagram of an implant provided by another embodiment of the present invention.

[0053] Fig.29 It is a schematic diagram of the structure of a repair system provided in one embodiment of the present invention.

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

[0055] Fig.31 It is a schematic diagram of the surgical path of a repair system provided by one embodiment of the present invention when applied to mitral annuloplasty.

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

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

[0058] The technical scheme in the embodiment of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiment of the present invention. Obviously, the described embodiment is only a part of the embodiment of the present invention, not all of the embodiments. Based on the embodiment 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 made with reference to the attached drawings to illustrate specific implementations of the present invention. Directional terms mentioned in the present invention, such as "top", "bottom", "front", "back", "left", "right", "inside", "outside", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and should not be understood as a limitation of 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 it can be indirectly connected through an intermediate medium, and it can be the internal connection of two elements.

[0061] In the field of interventional medical devices, the proximal end of a medical device refers to the end closer to the operator, while the distal end of a medical device refers to the end farther from the operator. Axial refers to the direction of the central axis of the device, radial refers to the direction perpendicular to the axial direction and where the radius or diameter is located, and circumferential refers to the direction perpendicular to and surrounding the axial direction. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0062] In the present invention, the terms "first", "second", and "third" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first", "second", and "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 sleeved 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 maintain an expanded state after being implanted into tissue.

[0064] The main body 10 of the anchor 100 of the present invention has a tip element 14 that is easy to penetrate into the tissue. The anchor 100 can be anchored into the tissue by pushing the anchor 100 through the delivery assembly. In addition, since the anchor 100 is provided with a connecting rod mechanism 30, the driving connector 20 can drive the connecting rod mechanism 30 to expand or collapse by moving along the axial direction of the guide rod 12. In order to facilitate transportation, before the anchor 100 is implanted, the anchor 100 is generally in a collapsed state, that is, the connecting rod mechanism 30 is collapsed into a substantially straight line. After the distal end of the anchor 100 in the collapsed state enters the tissue (at this time, the first connecting rod 32 partially enters the tissue), the driving connector 20 moves distally relative to the guide rod 12 to cause the connecting rod mechanism 30 to gradually expand radially and penetrate into the tissue, and the anchor 100 remains in the expanded state, thereby enhancing the anchoring force of the anchor 100. When the anchor 100 is implanted, it only needs to be moved distally without rotation, and the operation is simple and convenient.

[0065] Specifically, the first link 32 is rotatably connected to the second link 34. 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 link mechanism 30 is in the deployed state, the connector 20 is driven to move in the proximal direction relative to the guide rod 12, and the connector 20 pulls the first link 32 to move in the proximal direction, and the first link 32 drives the second link 34 to rotate relative to the tip element 14, so that the first link 32 and the second link 34 gradually approach the guide rod 12, so that the link mechanism 30 is in a retracted state. When the anchor 100 is transported, the link mechanism 30 remains in the retracted state, and the anchor 100 is pushed by the transport assembly to make the tip element 14 penetrate into the tissue until the link mechanism 30 partially enters the tissue. Then, the driving connector 20 moves in the distal direction relative to the guide rod 12, and the connector 20 pushes the first connecting rod 32 to move in the distal direction, and 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, so that the connecting rod mechanism 30 is in an expanded state and penetrates into the tissue, thereby enhancing the anchoring force of the anchor 100. It should be noted that when the connecting rod mechanism 30 is retracted, the anchor 100 is in a retracted state; when the connecting rod mechanism 30 is expanded, the anchor 100 is in an expanded 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 plurality 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 size of the patient's valve annulus 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 when implanted 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 may be a flexible linear object, such as a thread, a wire, a strip, a belt, a rope, etc. The radial cross-sectional shape of the flexible elongated member 310 may be circular, oblate, rectangular, square, or other shapes, etc. The flexible elongated member 310 may be made of a metal material and / or a polymer material, preferably a biocompatible material, such as stainless steel 316L, tungsten, tantalum, nickel titanium, polyethylene, polyamide, polypropylene, polyurethane, etc. 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 sleeved 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. In this way, the connecting hole 201 is provided on the connecting structure 23 connected to the connector 21.

[0070] exist Figures 1 to 3 In the example of, the connection structure 23 can be movably mounted on the connection member 21. The connection structure 23 can rotate relative to the connection member 21. When multiple anchors 100 are implanted in the valve annulus to adjust the size of the valve annulus, the flexible slender member 310 connected to the connection hole 201 of the connection structure 23 can pull the connection structure 23 to rotate relative to the connection member 21 and the main body 10, so that the connection hole 201 of each anchor 100 is basically arranged along the circumference of the valve annulus. In other examples, the connection structure 23 is fixed to the outer peripheral wall of the connection member 21. In other embodiments, the connection hole 201 can be directly provided in the connection 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 is provided with a first through hole 2121 extending along the axial direction of the guide rod 12. The second connecting member 214 is provided with a second through hole 2141 extending along the axial direction of 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 sleeved 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 cylinder, and the other is provided with a connecting groove. The connecting groove is connected to 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 by the cooperation of the connecting cylinder and the connecting groove. The connecting structure 23 can be movably sleeved on the connecting cylinder. In this way, the connecting structure can rotate relative to the connecting cylinder. The connecting cylinder 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 cylinder 2122, and the cylinder cavity of the connecting cylinder 2122 is a part of the first through hole 2121. The second connecting member 214 is provided with a connecting groove 2142, and the connecting groove 2142 is arranged along the edge of the second through hole 2141, and the connecting groove 2142 is connected to 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 to form a step surface 2143. The axial dimension L1 of the connecting cylinder 2122 is greater than the axial dimension L2 of the connecting groove 2142. The connecting cylinder 2122 is inserted into the connecting groove 2142 and abuts against the step surface 2143. The connecting structure 23 is sleeved on the part of the connecting cylinder 2122 exposed in the connecting groove 2142. Specifically, the connecting structure 23 includes an annular member 232, and the annular member 232 is movably sleeved on the part of the connecting cylinder 2122 exposed in the connecting groove 2142. The annular member 232 can rotate relative to the connecting tube 2122. It can be understood that the step surface 2143 can limit the length of the connecting tube 2122 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 step surface 2143. The first connecting member 212, the second connecting member 214 and the connecting structure 23 can be machined and formed using materials such as but not limited to 316L stainless steel, cobalt-chromium alloy, titanium, etc.

[0074] When assembling the connector 20, first, the annular member 232 of the connection structure 23 is sleeved on the connection cylinder 2122 of the first connection member 212, and then the connection cylinder 2122 is inserted into the connection groove 2142 of the second connection member 214 and abuts against the step surface 2143, and then the first connection member 212 and the second connection member 214 are fixed by welding. In some examples, the outer diameter OD1 of the connection cylinder 2122 is slightly smaller than the inner diameter ID3 of the annular member 232 of the connection structure 23, that is, the connection cylinder 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 connection groove 2142. In addition, the difference between the axial dimension L1 of the connection cylinder 2122 and the axial dimension L2 of the connection groove 2142 is slightly larger 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 is in the range of 0.03mm to 0.08mm, i.e., 0.03mm≤ID3-OD1≤0.08mm, and the sum of the axial clearances between the annular member 232 and the first connecting member 212 and the second connecting member 214 is in the range of 0.03mm to 0.08mm, i.e., 0.03mm≤L1-L2-L3≤0.08mm. Since the annular member 232 of the connecting structure 23 has a clearance in the radial direction relative to the connecting tube 2122 and a clearance in the axial direction relative to the first connecting member 212 and the second connecting member 214, the connecting structure 23 can rotate circumferentially relative to the connecting tube 2122. In other examples, the axial clearance between the annular member 232 of the connecting structure 23 and the first connecting member 212 and the second connecting member 214 is relatively large, 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 the connecting groove is connected to the first through hole 2121. The second connector 214 includes a connecting cylinder, and the cylinder cavity of the connecting cylinder is a part of the second through hole 2141. The radial dimension of the connecting groove is larger than the aperture of the first through hole 2121 to form a step surface, and the connecting cylinder can be inserted into the connecting groove and abut against the step surface. The connecting structure 23 is movably sleeved on the part of the connecting cylinder exposed in the connecting groove.

[0076] The specific structure of the anchor 100 is further described in detail below by taking an example where the first connecting member 212 includes a connecting tube 2122 and the second connecting member 214 has a connecting groove 2142 .

[0077] In some embodiments, see Figure 8 and Fig. 9The distal end surface of the tip element 14 is inclined toward the proximal end 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°, which facilitates the tip element 14 to penetrate into the tissue. The tip element 14 can be machined and formed using, but 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 matching 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 with 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 In the case where the connecting member 21 includes the first connecting member 212 and the second connecting member 214, after the first connecting member 212 and the second connecting member 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, wherein 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 may 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 relatively large, the matching clearance between the first through hole 2121 and the second through hole 2141 and the guide rod 12 is relatively large, which facilitates the connector 20 to move smoothly toward the distal end along the axial direction of the guide rod 12 so that the connecting rod mechanism 30 can be unfolded, avoiding jamming of the connector 20 when moving along the axial direction of the guide rod 12.

[0080] In some embodiments, see Figure 4 , Fig.10 and Fig.11, the 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 connecting rod mechanism 30 is in a retracted state, the tip portion 341 is received in the receiving groove 321. When the anchor 100 enters the tissue, the connecting rod mechanism 30 is in a retracted state, and the first connecting rod 32 drives the second connecting rod 34 to rotate so that the connecting rod mechanism 30 moves in the tissue when radially expanding, and the tip portion 341 leaves the receiving groove 321, and the tip portion 341 is easy to penetrate into the tissue and push away, so that the connecting rod mechanism 30 is in an expanded state.

[0081] Specifically, a needle tip 3411 is disposed 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 may be in the range of 15°≤A2≤40°. Fig.10 and Fig.11 In the example of the needle tip 3411, the needle tip 3411 includes two opposite inclined surfaces. The angle A2 of the needle tip 3411 is the angle between the two inclined surfaces of the needle tip 3411.

[0082] exist Fig.12 In the example of , the needle tip of the second connecting rod 34 can be multi-faceted sharpened. Fig.13 In the example of, the needle tip of the second connecting rod 34 can be sharpened circumferentially. In this way, the ability of the tip 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. The tip 341 of the second connecting rod 34 is respectively fixed with connecting studs 3413 on both sides, 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 to allow the connecting studs 3413 to enter the first mounting hole 323. The connecting studs 3413 and the first mounting hole 323 are clearance-matched. The tip 341 of the second connecting rod 34 is clearance-matched 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 by 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, the first connecting rod is penetrated in 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, so that the first connecting rod is 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 the assembly is completed, the first connecting rod is relatively fixed with 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, the proximal end of the tip element 14 of the body 10 is provided with a first accommodating groove 145. The first accommodating groove 145 is communicated with the inner hole 143. The tip element 14 is provided with third mounting holes 146 on opposite sides of the first accommodating groove 145. A fourth mounting hole 344 is provided at one 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 penetrates 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 connecting rod mechanism 30 also includes a second connecting rod 346. When the distal end of the second connecting rod 34 is placed in the first accommodating groove 145, the third mounting hole 146 and the fourth mounting hole 344 are opposite, and the second connecting rod 346 is penetrated in 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 matched with the third mounting hole 146 and the fourth mounting hole 344, so that the second connecting rod 346 can 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 matched with the first accommodating groove 145. After the assembly is completed, the second connecting rod 346 is relatively fixed with the third mounting hole 146, and the second connecting rod 346 is rotationally matched 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 in 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, the second connecting rod 346 is relatively fixed with the fourth mounting hole 344, and the second connecting rod 346 is rotationally matched 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 connector 20 to move along the axial direction of the guide rod 12 to pull the first connecting rod 32 to drive the second connecting rod 34 to rotate.

[0089] In the case where the connecting member 21 includes the first connecting member 212 and the second connecting member 214, the second receiving groove 215 is arranged at the distal end of the second connecting member 214. The second receiving groove 215 is communicated 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. The first connecting rod 32 is provided with a sixth mounting hole 324 at one end away from the receiving groove 321 (i.e., the proximal end of the first connecting rod 32). The sixth mounting hole 324 penetrates 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 opposite, and the third connecting rod 326 is penetrated in the fifth mounting hole 2152 and the sixth mounting hole 324, and the third connecting rod 326 and the second connecting member 214 are fixed by welding or gluing. The third connecting rod 326 is loosely matched with the fifth mounting hole 2152 and the sixth mounting hole 324, so that the third connecting rod 326 can 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 matched with the second accommodating groove 215. After the assembly is completed, the third connecting rod 326 is relatively fixed with the fifth mounting hole 2152, and the second connecting rod 346 is rotationally matched 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 in 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, the third connecting rod 326 is relatively fixed with the sixth mounting hole 324, and the second connecting rod 346 is rotationally matched 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 and formed by, but not limited to, 316L stainless steel, cobalt-chromium alloy, or nickel-titanium alloy. The first connecting rod, the second connecting rod 346 and the third connecting rod 326 can be made of, but not limited to, 316L stainless steel, cobalt-chromium alloy, titanium and the like.

[0091] In some embodiments, see Figure 4 , Figure 8 and Fig. 9, the 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 arranged 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 fits with the avoidance position 123, and the tip portion 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 setting 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 also provided with a positioning groove 216. The guide rod 12 is provided with a positioning portion 125. The positioning portion 125 is constructed to cooperate with the positioning groove 216 to limit the proximal 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 in a direction away from the tip element 14). In this way, the link mechanism 30 can be kept 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 return to a straight position, thereby keeping the link mechanism 30 in an expanded state, further improving the anchoring force of the anchor 100. In the case where 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] Further, 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 arranged in the window 127. It can be understood that the positioning portion 125 is arranged corresponding to the position where the window 127 is provided in the guide rod 12. When the connector 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 connector 20, the positioning portion 125 is radially squeezed 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. When the connector 20 continues to move toward the distal end and the positioning groove 216 of the connector 21 faces the window 127, the positioning portion 125 is no longer squeezed by the connector 21, and the positioning portion 125 is inserted into the positioning groove 216 to limit the connector 20 from moving toward the proximal end relative to the guide rod 12, and the connecting rod mechanism 30 remains in the deployed state. The guide rod 12 can be made of nickel-titanium alloy as a whole, and the positioning portion 125 is formed by laser cutting the window 127, and then heat-setting. The guide rod 12 can also be made of other biocompatible materials, as long as the positioning portion 125 is elastic.

[0094] like Figure 5 , Figure 7 and Fig. 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 proximal movement of the connector 20, 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, so that the anchor 100 is convenient for piercing the tissue.

[0095] exist Figures 4 to 7 In the example of , the second connecting member 214 is provided with two spaced positioning grooves 216, and the guide rod 12 is correspondingly provided with two spaced positioning portions 125. The two positioning portions 125 are respectively matched with the two positioning grooves 216. Optionally, the two positioning grooves 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 grooves 216 and positioning portions 125 may also be provided according to actual use requirements.

[0096] In some embodiments, see Figures 14 to 17 The outer peripheral wall of the guide rod 12 is also provided with a stopper 128. The stopper 128 is closer to the tip element 14 than the positioning portion 125. The stopper 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). Fig.14 The collapsed state shown is transformed into Fig.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, it is possible to avoid the connector 20 from moving excessively distally, resulting in abnormal morphology of the anchor 100, and 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 to the position of the limiter 128, the limiter 128 and the tissue are in contact with each other, and there is resistance between the two. This resistance can prevent the anchor 100 from continuing to be implanted, thereby controlling the depth of the anchor 100 implanted in the tissue and avoiding excessive expansion of the connecting rod mechanism 30, which affects the implantation effect of the anchor 100.

[0097] It can be understood that the positioning portion 125 cooperates with the positioning groove 216 of the second connecting member 214 to limit the proximal movement of the connector 20 relative to the guide rod 12, so that the connecting rod mechanism 30 can remain in the expanded state after the anchor 100 is implanted in the tissue. The limiter 128 limits the distal movement of the connector 20 relative to the guide rod 12 to prevent the connecting rod mechanism 30 from being over-expanded and affecting the implantation effect 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 the stopper blocks can be one, two, three, four or more than four. When the number of the stopper blocks is two or more, the stopper blocks can be evenly spaced along the circumference of the guide rod. Of course, the spacing between the stopper blocks can also be uneven. The stopper 128 can also be an annular block protruding around the outer peripheral wall of the guide rod 12.

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

[0100] In some embodiments, see Figures 18 to 20, the connection 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 is provided with 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. Since the mounting hole of the protrusion 2323 penetrates the protrusion 2323 in the radial direction of the anchor 100, the collar 235 can rotate around the mounting hole so that the collar 235 is close to the first connecting member 212 or the second connecting member 214, thereby reducing the outer diameter of the connection structure 23.

[0101] In some embodiments, see Figure 21 to Figure 23 The connection 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 connection ring. The connection ring is provided with a mounting hole, and the collar 235 is movably inserted into the mounting hole to be movably connected with the connection ring. The collar 235 defines a connection hole 201. The flexible elongated member 310 passes through the connection hole 201 of the collar 235 and is connected to the anchor 100. Since the mounting hole of the connection ring passes through the connection ring in the radial direction of the anchor 100, the collar 235 can rotate around the mounting hole so that the collar 235 is close to the first connection member 212 or the second connection member 214, thereby reducing the outer diameter of the connection structure 23.

[0102] See also Fig.24 The connection structure 23 may also include only a connection ring 2321, and the connection ring 2321 defines a connection hole 201. The connection hole 201 penetrates 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. At least two linkage mechanisms 30 are arranged at intervals around the circumference of the guide rod 12. Specifically, the anchor 100 may be provided with 2 to 8 linkage mechanisms 30. Optionally, if the anchor 100 includes 2 linkage mechanisms 30, the 2 linkage mechanisms 30 are arranged at intervals around the circumference of the guide rod 12 and are symmetrically arranged about the central axis of the guide rod 12. Optionally, if the anchor 100 includes 3 to 8 linkage mechanisms 30, the plurality of linkage mechanisms 30 are evenly spaced around the circumference of the guide rod 12. Optionally, at least two linkage mechanisms 30 are arranged at intervals around the circumference of the guide rod 12, and the intervals thereof may also be unequal.

[0104] exist Figure 1 and Figure 2In the example, the number of the connecting rod mechanisms 30 of the anchor 100 is two, and the two connecting rod mechanisms 30 are symmetrically arranged about the central axis of the guide rod 12. The number of the second receiving grooves 215 of the second connecting member 214, the number of the first receiving grooves 145 of the tip element 14, the number of the corresponding structures such as the avoidance position 123 should be set to two accordingly. The avoidance position 123, the first receiving groove 145, and the second receiving groove 215 correspond one to one, and the avoidance position 123 and the first receiving groove 145 and the second receiving groove 215 are kept arranged on the same side of the guide rod 12.

[0105] exist Fig.14 and Fig.15 In the example, the number of the connecting rod mechanism 30 of the anchor 100 is preferably 4, and the 4 connecting rod mechanisms 30 are evenly spaced around the circumference of the guide rod 12. The number of the second receiving grooves 215 of the second connecting member 214, the number of the first receiving grooves 145 of the tip element 14, the number of the corresponding structures such as the avoidance position 123 should be set to 4 accordingly. The avoidance position 123, the first receiving groove 145, and the second receiving groove 215 correspond one to one, and the avoidance position 123 and the first receiving groove 145 and the second receiving groove 215 are kept on the same side of the guide rod 12. The positioning portion 125 is set away from the avoidance position 123, so that the connecting rod mechanism 30 does not affect the size of the outer diameter of the anchor 100 when it is retracted.

[0106] See also Figure 4 , Fig.25 and Fig.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 inserted into the delivery sheath 221. The connector 20 is provided with a first joint portion 202, and the delivery sheath 221 is provided with a second joint portion 2212. The first joint portion 202 is detachably connected to the second joint portion 2212. 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 can be understood that after the first joint portion 202 and the second joint portion 2212 of the connector 20 are connected, the connecting rod 223 inserted in the delivery sheath 221 passes through the joint of the first joint portion 202 and the second joint portion 2212 and is connected to the guide rod 12, so that the connection between the connector 20 of the anchor 100 and the delivery sheath 221 can be maintained. After the anchor 100 is assembled with the delivery assembly 220, the delivery sheath 221 and the connecting rod 223 are pushed at the same time to drive the anchor 100 to be implanted into the tissue. When the distal end of the anchor 100 in the retracted state enters the tissue (at this time, the first connecting rod 32 partially enters the tissue), the delivery sheath 221 pushes the connector 20 of the anchor 100 to move toward the distal end of the guide rod 12 relative to the connecting rod 223 (that is, the delivery sheath 221 moves toward the distal end alone, and the connecting rod 223 does not move), and the connecting rod mechanism 30 gradually expands radially in the tissue. The anchor 100 can maintain an expanded state in the tissue. Specifically, the anchor 100 cooperates with the positioning groove 216 of the connector 21 through the positioning portion 125 to keep the link mechanism 30 deployed. When releasing the anchor 100, it is only necessary to release the connecting rod 223 from the guide rod 12 and withdraw the connecting rod 223 so that the connecting rod 223 is evacuated from the joint of the first joint portion 202 and the second joint portion 2212, and the delivery sheath 221 can be separated from the connector 20.

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

[0109] In some embodiments, the first engaging portion 202 and the second engaging portion 2212 may be complementary S-shaped buckles. After the two S-shaped buckles are buckled together, an inner cavity is formed, 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 engaging portion 202 and the second engaging portion 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 connection between the connector 20 and the delivery sheath 221.

[0110] In some embodiments, the connecting rod 223 is detachably connected to the guide rod 12 through the cooperation of the 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 so that the connecting rod 223 and the guide rod 12 are detachably connected. 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, and the screw hole 129 is a 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 can be understood 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 withdrawn to make the connecting rod 223 withdraw from the joint between the first joint portion 202 and the second joint portion 2212, and then the delivery sheath 221 is withdrawn, and the second joint portion 2212 can be separated from the first joint portion 202. Since the second joint portion 2212 of the delivery sheath 221 and the first joint portion 202 of the connector 20 are mutually limited, when the connecting rod 223 rotates relative to the delivery sheath 221, the delivery sheath 221 can limit the anchor 100 from rotating with the connecting rod 223, thereby facilitating the separation of the threaded column and the screw hole.

[0112] See also Figure 4 and Fig. 27 The embodiment of the present invention further provides an implant 300. The implant 300 includes a plurality of anchors 100, a flexible elongated member 310, and a locker 330. The flexible elongated member 310 is connected to the 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 locker 330 is configured to lock the length of the flexible elongated member 310 to maintain the tension of the flexible elongated member 310.

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

[0114] After the connection 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 the flexible elongated member 310 and the connection structure 23 of the first anchor 100 can be inseparable and always kept connected by knotting, winding, welding, or bonding. The connection 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 connection structures 23 of the remaining anchors 100.

[0115] See also Fig.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 can be understood that the spacer 350 can prevent the flexible elongated member 310 from being over-tightened, resulting in the distance between the two adjacent anchors 100 being too short. At the same time, the spacer 350 can play a buffering role, dispersing the tightening force on the anchor 100, and ensuring the stability of the anchor 100 implantation. Among them, the spacer 350 is a cylindrical member with a certain length, preferably made of a biocompatible material. The spacer 350 can be wrapped with a coating to reduce the risk of heart 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, that is, the anchors 100 and the spacers 350 are staggered. Of course, a spacer 350 may also be provided every two or more anchors 100, that is, a spacer 350 is provided between some adjacent two anchors 100, and no spacer 350 is provided between some adjacent two anchors 100, and the present invention is not limited to this.

[0117] See also Fig.29 The embodiment of the present invention further provides a repair system 400. The repair system 400 includes an implant 300 and a conveying member 410. The distal end of the conveying member 410 is connected to the proximal end of the flexible elongated member 310. A plurality of anchors 100 and a locker 330 are conveyed to the flexible elongated member 310 along the conveying member 410. It can be understood that the distal end of the flexible elongated member 310 is connected to the first anchor 100. The flexible elongated member 310 and the conveying member 410 enter the patient's body along with the delivery of the first anchor 100, and the proximal end of the conveying member 410 extends outside the body. In this way, the connection structure of the anchor 100, the spacer 350, the locker 330, etc. can be worn on the flexible elongated member 310 through the delivery of the conveying member 410, so that the flexible elongated member 310 can select a suitable implantation length, so that the flexible elongated member 310 does not need to be cut in the body, and the particles on the wire are avoided from falling off, and the operation is safer.

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

[0119] In some embodiments, the proximal end of the flexible elongated member 310 is connected to the distal end of the conveying member 410 in a U-shaped manner. The conveying member 410 can be separated from the flexible elongated member 310 by pulling the conveying member 410 outside the body, which is easy to operate. In other embodiments, the conveying member 410 can also be detachably connected to the flexible elongated member 310 by means of threaded connection, snap connection, etc., which will not be described in detail.

[0120] In other embodiments, the repair system 400 can omit the conveyor 410, and the length of the flexible elongated member 310 is long enough. When the flexible elongated member 310 enters the heart with the first anchor 100, the proximal end of the flexible elongated member 310 can extend outside the patient's body. In this way, multiple anchors 100 are implanted and the flexible elongated member 310 is tightened to reduce the valve ring. After the valve ring is reduced to the desired effect, the length of the flexible elongated member 310 can be locked by the locker 330 to maintain the tension of the flexible elongated member 310, thereby maintaining the effect of reducing the valve ring. The excess part of the flexible elongated member 310 can be cut off by a wire cutter.

[0121] See also Fig.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 conveying assembly 220 is flexible. After the anchor 100 is assembled with the conveying assembly 220, the conveying 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 are convenient for adjusting the bending degree and direction of their distal portions, so that the inner sheath 450 can be easily adjusted to the vicinity of the heart tissue. The anchor 100 is in a retracted state during transportation, and the anchor 100 can be moved in the inner sheath 450 by the push of the conveying assembly 220.

[0122] Please also read Figure 31 to Figure 36, the use process and working principle of the repair system 400 of the embodiment of the present invention are explained by taking the application of the repair system in mitral annuloplasty as an example. 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 slender member 310 is connected to the first anchor 100, and the proximal end of the flexible slender member 310 is U-shapedly connected to the distal end of the conveying member 410. The first anchor 100 is assembled with the conveying assembly 220 and loaded into the inner sheath 450 together.

[0123] Step 1: If Fig.31 As shown, the outer sheath 430 is guided into the left atrium LA through the femoral vein access and conventional access methods such as atrial septal puncture 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 Fig.32 As shown, first, the delivery assembly 220 and the anchor 100 are adjusted to a certain target position of the mitral valve annulus MVA through the inner sheath tube 450, and the delivery sheath 221 and the connecting rod 223 of the delivery assembly 220 are pushed distally at the same time, so that the tip element 14 of the anchor 100 is inserted into the tissue. When the positioning portion 125 of the anchor 100 approaches the tissue, the delivery sheath 221 and the connecting rod 223 are stopped from being pushed. Then, the delivery sheath 221 is pushed distally alone, and the connector 20 moves distally along the guide rod 12 to drive the first connecting rod 32 and the second connecting rod 34 to gradually expand in the tissue. The delivery sheath 221 continues to be pushed until the positioning portion 125 of the guide rod 12 is stuck in the positioning groove 216 of the second connecting member 214, and the connecting rod mechanism 30 is fully expanded. Next, the connecting rod 223 is rotated relative to the delivery sheath 221 to release the connecting rod 223 and the guide rod 12 of the anchor 100, and the connecting rod 223 is withdrawn to withdraw the connecting rod 223 from the joint between 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 axially push the delivery sheath 221 and the connecting rod 223 , and it is not necessary to rotate the delivery sheath 221 , which will not cause the anchor 100 to be entangled with the flexible elongated member 310 and the delivery member 410 .

[0126] Step 3: If Fig.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 Fig.34 and Fig.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 Fig.36 and Fig.28 As shown, first, the locker 330 is sent to the flexible elongated member 310 along the conveying member 410. Then, the locker 330 is controlled to adjust the length of the flexible elongated member 310 on the valve ring to reduce the spacing between the plurality of anchors 100, thereby reducing the valve ring. After achieving a good ring shrinking effect, the locker 330 locks the length of the flexible elongated member 310 to maintain tension. It should be noted that the conveying member 410 can be withdrawn after the flexible elongated member 310 is stably connected to the locker 330.

[0129] It is understood that the repair system 400 can also be applied to tricuspid annuloplasty, and its operation is similar to the above-mentioned 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, in the absence of conflict, the embodiments and features in the embodiments of the present invention can be combined with each other, and any combination of features in different embodiments is also within the protection scope of the present invention. In other words, the multiple embodiments described above can also be combined arbitrarily according to actual needs.

[0131] It should be noted that all the above-mentioned drawings are exemplary diagrams of the present invention and do not represent the actual size of the product. And the dimensional ratio relationship between the components in the drawings is not intended to limit 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 protection scope of the present invention is not limited to this. Any technician familiar with the field can easily think of changes or replacements within the technical scope disclosed by the present invention, which should be covered within the protection scope 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, the main body comprising a guide rod and a tip element connected to the guide rod; A connecting head, the connecting head is 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 maintain 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, and 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 by 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, and 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, and the avoidance position and the first accommodating groove and the second accommodating groove are arranged on the same side of the guide rod, and 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, and the positioning portion is configured to cooperate with the positioning groove to limit the proximal movement of the connecting head 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 part 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 also provided with a limiter, which is closer to the tip element than the positioning portion, and is configured to stop the connector to limit the distal movement of the connector relative to the guide rod.

14. The anchor according to claim 2, characterized in that: The anchor comprises at least two linkage mechanisms, and the at least two linkage mechanisms are arranged at intervals 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 inserted into 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, a 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 comprises 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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