System for deploying a heart anchor

Abstract

A system for deploying a cardiac anchor includes a catheter, a cardiac anchor carried within the catheter, and a driver. The heart anchor includes a locking assembly to which a medical wire is attached and an anchor rotatably connected to the locking assembly, and a driver engaged with the anchor and extending proximally through the catheter. The driver is used for spirally propelling the anchor to drive the heart anchor to move from the first position to the second position of the catheter; at the moment, the anchoring piece can be spirally pushed out from the far end of the catheter to be anchored into the heart tissue, and the locking assembly is limited by the catheter in the circumferential direction and axially moves to the second position so that the locking assembly can lock the medical wire at the second position. The system not only can effectively protect the medical wire to avoid the risks of abrasion, wire twisting and torsion of the medical wire, but also further guarantees the adjusting function of the medical wire, thereby being beneficial to guaranteeing the success rate of an operation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a system for deploying a cardiac anchor. Background Art

[0002] With the continuous extension of life expectancy and the gradual deepening of the aging process, the incidence of mitral regurgitation has been increasing year by year, and mitral regurgitation is one of the most common valvular diseases, which seriously threatens the life of patients. The mitral valve is a one-way valve connecting the left atrium and the left ventricle, which includes structures such as the valve ring, anterior leaflet, posterior leaflet, chordae tendineae, and papillary muscles. When the heart is in diastole, the anterior leaflet and posterior leaflet open, and blood flows from the atrium to the ventricle; when the heart is in contraction, blood flows from the ventricle to the aorta, and the anterior leaflet and posterior leaflet are completely closed under the traction of the chordae tendineae to prevent blood from flowing back from the ventricle to the atrium. However, when the relevant structures of the mitral valve are diseased, such as chordae tendineae disease or rupture, resulting in leaflet prolapse, valve ring expansion, etc., the anterior leaflet and posterior leaflet will not be completely in sync when the heart contracts, causing blood to flow back from the ventricle to the atrium, thereby causing mitral regurgitation.

[0003] For problems such as mitral valve insufficiency caused by chordal disease or rupture, the prior art usually adopts the method of artificial chord implantation to replace the diseased or broken chords to achieve the purpose of repair. Based on the structural principle of native chords, it is generally necessary to use a suturing device to fix one end of the artificial chord to the valve leaflet end, and use an anchoring device to fix the other end of the artificial chord to the ventricular end or the papillary muscle to complete the implantation of the artificial chord. The prior art discloses an anchoring device, which includes a spiral nail for anchoring into the tissue and a locking wire part for locking the artificial chord, and the spiral nail and the locking wire part are relatively fixed. In view of the fact that the spiral nail and the locking wire part have the same motion state, when the anchoring device is spirally pushed out from the anchor catheter and anchored into the ventricular end, the artificial chord is very likely to be tangled or twisted. Specifically, the prior art generally passes the artificial chords through the spiral nail and the locking wire portion at the same time to avoid the problem of tangling of the wires. However, this easily leads to the risk of the sharp end of the spiral nail scratching the artificial chords, causing damage or breakage of the artificial chords. Moreover, in the process of winding the artificial chords around the spiral nail, there is a risk that the artificial chords may be entangled with the spiral nail due to incomplete winding or excessive winding, thereby causing the anchored artificial chords to be unable to achieve the adjustment function, resulting in the serious consequence of failure of the artificial chord implantation. Summary of the invention

[0004] The object of the present invention is to provide a system for deploying a cardiac anchor, which can not only effectively protect the medical wire to avoid the risks of wear, tangling and twisting of the medical wire, but also further ensure the adjustment function of the medical wire, thereby ensuring the success rate of the operation.

[0005] In order to achieve the above object, the present invention provides a system for deploying a cardiac anchor, the system comprising:

[0006] a catheter having a distal end and a proximal end;

[0007] a cardiac anchor carried in the catheter, the cardiac anchor comprising a locking assembly and an anchor rotatably connected to a distal end of the locking assembly, the locking assembly being attached with a medical wire; and

[0008] an actuator carried within the catheter, the actuator engaging the anchor and extending proximally through the catheter;

[0009] The driver is used to spirally advance the anchor to drive the heart anchor to move from the first position of the catheter to the second position of the catheter, the anchor is spirally pushed out from the distal end of the catheter to anchor into the heart tissue, and the locking assembly is circumferentially limited by the catheter and axially shifted to the second position so that the locking assembly can lock the medical wire at the second position.

[0010] The system for deploying the cardiac anchor provided by the present invention has a locking assembly that can achieve axial displacement relative to the catheter under the joint action of the anchor and the catheter when the anchor moves in the catheter in a spiral propulsion manner, so that the medical wire attached to the locking assembly only undergoes axial displacement. This not only effectively avoids the defects of twisting or torsion of the medical wire in the prior art, but also further ensures the adjustment function of the medical wire, thereby ensuring the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0012] Figure 1 An overall schematic diagram of a system for deploying a cardiac anchor in some embodiments is shown.

[0013] Figure 2 Shows Figure 1 The system shown is in an initial state.

[0014] Figure 3 Shows Figure 1 The system is shown in a state diagram in which the anchoring is completed.

[0015] Figure 4 Shows Figure 1 The system is shown in a schematic diagram showing a state where the locking line is completed.

[0016] Figure 5 Shows Figure 2 Schematic diagram of the position of the positioning end and the guide groove in the system shown.

[0017] Figure 6 Shows Figure 5 Schematic diagram of the structure of the sleeve in the system shown.

[0018] Figure 7 A schematic structural diagram of the heart anchor in the first embodiment is shown.

[0019] Figure 8 Shows Figure 7 Schematic diagram of the structure of the anchor.

[0020] Figure 9-10 Shows Figure 7 Schematic diagram of the structure of the assembly of the middle anchor and the locking component.

[0021] Figure 11-12 Shows Figure 7 Diagram of different engagement states of the central anchor and driver.

[0022] Fig.13 Shows Figure 7 Exploded view of the mid-heart anchor.

[0023] Fig.14 Shows Fig.13 A side view of the main body.

[0024] Fig.15 Shows the Figure 7 Schematic diagram of the central heart anchor used in the system.

[0025] Figure 16-18 Shows Fig.13 A side sectional view of the main body and locking wire parts of different structures.

[0026] Figure 19-20 Shows Figure 7 A side sectional view of different self-locking mechanisms disposed between the main body and the thread locking member.

[0027] Figure 21-22 They are shown respectively Figure 7 Schematic diagram of the structure of the thread locking parts and cloth cover.

[0028] Figure 23-24 A schematic diagram showing the state of a locking assembly with a cloth cover in an initial state and a line locking state.

[0029] Fig.25 It shows that there will be Figure 7A schematic diagram of a cardiac anchor system shown is deployed intraventricularly to the mitral valve via a transcatheter approach.

[0030] Fig.26 The positioning pin is shown in Fig.25 A side cutaway view of the system shown.

[0031] Fig. 27 Shows the Fig.26 Schematic diagram of positioning needle insertion into the papillary muscle shown in .

[0032] Fig.28 A schematic diagram showing the completion of anchoring of the cardiac anchor is shown.

[0033] Fig.29 A schematic diagram showing the completion of the cardiac anchor lockwire.

[0034] Figure 30-31 Schematic diagrams showing the release of the actuator and the driver from the heart anchor are shown respectively.

[0035] Fig.32 A schematic diagram showing the withdrawal of the system to leave behind the medical line and cardiac anchor.

[0036] Figure 33-34 A side schematic diagram and a three-dimensional schematic diagram of the heart anchor in the second embodiment are shown.

[0037] Fig.35 Shows Fig.33 Side cutaway view of the mid-heart anchor.

[0038] Fig.36 Shows the Fig.33 The cardiac anchor is used in Figure 1 A three-dimensional schematic diagram of the system in .

[0039] Fig.37 for Fig.36 The system shown is in an initial state.

[0040] Fig.38 for Fig.36 The system is shown in a state diagram in which the anchoring is completed.

[0041] Fig.39 for Fig.36 The system is shown in a schematic diagram showing a state where the locking line is completed.

[0042] The following specific implementation manner will further illustrate the present invention in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0043] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the 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.

[0044] In addition, the following descriptions of the embodiments are made with reference to the attached diagrams to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached diagrams. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0045] It should be noted that, in order to more clearly describe the system for deploying a cardiac anchor provided by the present invention, the limiting terms "proximal end" and "distal end" described in the specification of the present invention are all conventional terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, and "proximal end" refers to the end close to the operator during the surgical operation; the direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial or longitudinal axis; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction is the direction along the diameter or radius. It is worth noting that the "end" in the terms such as "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end" and "lower end" is not limited to the end, end point or end face, but also includes a portion extending from the end, end point, or end face on the element to which the end, end point, or end face belongs to a certain axial distance and / or radial distance. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those generally understood by technicians in the technical field of the present invention. The conventional terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not to be construed as limiting the present invention.

[0046] The present invention provides a system for deploying a cardiac anchor, which can obtain a path close to the heart valve through a transapical or transcatheter approach, so as to deploy the cardiac anchor to a target position inside the heart to lock one or more medical wires, thereby performing valve repair of the mitral valve or tricuspid valve to prevent mitral valve or tricuspid valve regurgitation.

[0047] Figure 1-4A schematic diagram of a system 100 for deploying a cardiac anchor in some embodiments is shown, wherein the system 100 includes a catheter 10, a cardiac anchor 20, and a driver 30. The cardiac anchor 20 is removably carried in the catheter 10 and is attached with a medical line 40. The driver 30 is carried in the catheter 10 for driving the cardiac anchor 20. Specifically, the catheter 10 has a distal end and a proximal end opposite to each other. The cardiac anchor 20 is carried at the distal end of the catheter 10. The medical line 40 attached to the cardiac anchor 20 extends toward the proximal end to pass through the catheter 10 (see FIG. Figure 2-3 ) or along the outside of the catheter 10 (see Figure 1 ) passes out of the body, and the driver 30 extends proximally through the catheter 10. Further, the cardiac anchor 20 includes a locking assembly 21 and an anchor 22, wherein the anchor 22 is rotatably connected to the locking assembly 21, and the locking assembly 21 is circumferentially confined within the catheter 10. Among them, the medical wire 40 is attached to the locking assembly 21, and the driver 30 is engaged with the anchor 22 of the cardiac anchor 20 to drive the anchor 22 to move within the catheter 10. When the driver 30 spirally advances the anchor 22 to drive the cardiac anchor 20 to shift distally to move from the first position of the catheter 10 to the second position of the catheter 10, the anchor 22 can be spirally pushed out from the distal end of the catheter 10 to anchor into the heart tissue, and the locking assembly 21 is circumferentially confined by the catheter 10 and axially shifted to the second position within the catheter 10, at which time the locking assembly 21 can lock the medical wire 40 at the second position. It should be particularly noted that the first position and the second position represent two different positions or different regions of the cardiac anchor 20 relative to the catheter 10, and do not refer to specific fixed positions or specific structures.

[0048] Compared with the prior art, the cardiac anchor provided by the present invention has an anchor that is rotatably connected to the locking assembly, and the medical line is only attached to the locking assembly, thereby effectively avoiding the defect in the prior art that the sharp end of the anchor scratches the medical line because the medical line needs to pass through the anchor. At the same time, when the system provided by the present invention moves in the catheter in a spirally advanced manner, the locking assembly will not rotate with the anchor under the joint action of the anchor and the catheter, but only completes the axial displacement relative to the catheter. At this time, the medical line attached to the locking assembly will only undergo axial displacement, thereby effectively avoiding the huge risk of the prior art that the medical line cannot achieve the adjustment function due to the twisting or torsion of the medical line, which ultimately leads to implant failure. Therefore, the system provided by the present invention greatly guarantees the success rate of the operation.

[0049] It is understood that in the first position, the system 100 is in an initial state, such as Figure 2As shown. At this time, the cardiac anchor 20 is carried on the distal end of the catheter 10, the locking assembly 21 is circumferentially limited to the distal end of the catheter 10, and the anchor 22 extends from the locking assembly 21 to the distal end to be rotatably connected to the locking assembly 21; that is, the anchor 22 and the locking assembly 21 can rotate relative to each other in the circumferential direction, but are axially fixed and inseparable. After the medical line 40 is movably attached to the locking assembly 21, it further extends proximally through the catheter 10. At this time, the medical line 40 can be pulled to move freely at the locking assembly 21. The distal end of the driver 30 is connected to the proximal end of the anchor 22. The driver 30 is used to drive the cardiac anchor 20 to move in the catheter 10, and the proximal end of the driver 30 extends through the catheter 10. Among them, the driver 30 is removably connected to the anchor 22, so that after the cardiac anchor 20 is anchored into the heart tissue, the driver 30 can be detached from the cardiac anchor 20 and withdrawn from the heart tissue to the outside of the body. In some embodiments, the first position represents the position or area of ​​the cardiac anchor 20 in the catheter 10 when the system 100 is in the initial state. At the same time, in order to avoid the risk of human tissue around the system 100 being accidentally scratched by the sharp end of the anchor 22, the anchor 22 is generally set at a safety distance relative to the distal opening of the catheter 10 to prevent the sharp end of the anchor 22 from being exposed outside the catheter 10. The safety distance refers to the axial distance from the sharp end of the anchor 22 to the distal opening of the catheter 10.

[0050] Then, when the anchor 22 is screwed forward by the driver 30 to drive the cardiac anchor 20 to move automatically, Figure 2 The first position shown is displaced distally to Figure 3 In the second position shown, the system 100 switches from the initial state to the anchoring completion state, at which time the anchor 22 of the cardiac anchor 20 has been anchored and positioned in the cardiac tissue. In some embodiments, the second position represents the position or area of ​​the cardiac anchor 20 in the catheter 10 when the system 100 is in the anchoring completion state.

[0051] Furthermore, if Figure 2-4As shown, in order to ensure that the system 100 can actuate the locking assembly 21 at the second position to lock the medical wire 40, the system 100 also includes an actuator 50, which is carried in the catheter 10 and extends through the catheter 10 proximally. The actuator 50 can be carried in the catheter 10 in parallel with the driver 30, or after the driver 30 drives the cardiac anchor 20 to complete the anchoring operation and withdraw it outside the body, the actuator 50 is then delivered and carried in the catheter 10 for subsequent operations. Specifically, the distal end of the actuator 50 is removably engaged with the locking assembly 21, so as to actuate the locking assembly 21 to lock the medical wire 40 and then release it from the cardiac anchor 20, and then withdraw it from the heart tissue to the outside of the body. In some embodiments, once the cardiac anchor 20 is anchored, the medical wire 40 is adjusted to an appropriate tension to achieve optimal valve function. Next, the locking assembly 21 is actuated by the actuator 50 in a non-helical manner to lock the medical line 40 and keep it under the appropriate tension; for example, the actuator 50 can use a non-helical manner such as pressure, tension, thrust, etc. to actuate the deformation or movement of the locking assembly 21 to lock the medical line 40 at the locking assembly 21, thereby ensuring that the advancement method is different from that of the anchor 22, so as to avoid the defect that the anchor 22 is driven to excessively anchor into or rotate out of the tissue when locking the line due to the same advancement method, and finally causes implant failure. Further, the locking assembly 21 includes a main body 211 and a locking wire member 212 movably connected to the main body 211, and the medical line 40 is movably attached between the main body 211 and the locking wire member 212. The actuator 50 engages with the locking wire member 212 to actuate the locking wire member 212 to move relative to the main body 211 to lock the medical line 40. That is, during the process of locking the medical line 40 , the main body 211 remains fixed at the second position, so the stability of the anchoring member 22 after anchoring is not affected.

[0052] In some embodiments, the system 100 further includes a handle 60 disposed at the proximal end of the catheter 10. The proximal end of the driver 30 extends through the catheter 10 and is connected to a driving mechanism (not shown) of the handle 60, and the driving mechanism on the proximal handle 60 is manipulated to actuate the driver 30 to move, such as spirally advancing toward the distal end. The proximal end of the actuator 50 extends through the catheter 10 and is connected to an actuating mechanism (not shown) of the handle 60, and the actuating mechanism on the proximal handle 60 is manipulated to actuate the actuator 50 to move, such as axially pulling, axially pushing, or axially releasing toward the proximal end.

[0053] It is understandable that the catheter 10 and the locking assembly 21 can achieve circumferential limitation of the two by providing mutually matching guide grooves and guide parts. Specifically, the catheter 10 is a hollow flexible elongated tube body, and has a side wall extending from the distal end to the proximal end of the catheter 10. For example, Figure 1-6In the manner shown, an axially extending guide groove 11 is provided on the side wall of the catheter 10, and a radially extending guide portion 210 is provided on the locking assembly 21, and at least part of the circumference of the guide portion 210 is limited in the guide groove 11 and can move axially along the guide groove 11. Alternatively, a guide portion is provided on the side wall of the catheter 10 protruding radially inward, and an axially extending guide groove is provided on the locking assembly 21, so that the guide portion of the catheter 10 can move axially along the guide groove (not shown). In view of the fact that when the cardiac anchor 20 moves in the catheter 10, it is very easy for the radial displacement of the cardiac anchor 20 to change, causing the anchoring position of the cardiac anchor 20 to deviate from the target position, thereby affecting the anchoring effect of the cardiac anchor 20, and in severe cases, there may be a risk of anchoring failure. The present invention further configures a positioning end on the guide portion 210 to ensure that the radial position of the cardiac anchor 20 does not change when it is anchored into the heart tissue. Specifically, as Figure 5 As shown, the end of the guide portion 210 extending out of the guide slot 11 is formed with a positioning end 2100 with an increased width, and the positioning end 2100 abuts against the outside of the guide slot 11 to ensure that the radial position of the cardiac anchor 20 remains unchanged when the cardiac anchor 20 moves in the catheter 10. At this time, the longitudinal center axis of the anchor 22 can continue to roughly overlap with the longitudinal center axis of the catheter 10 to ensure that the anchor 22 can continue to remain in the center of the catheter 10 during the delivery process. In some embodiments, the positioning end 2100 is a lug with an increased width extending from the end of the guide portion 210 extending out of the guide slot 11, and the lug 2100 radially abuts against the outside of the side wall of the catheter 10, and can follow the guide portion 210 to slide axially along the trajectory of the guide slot 11 outside the guide slot 11. It can be understood that the width W1 of the lug 2100 is greater than the width W2 of the guide slot 11 to prevent the lug 2100 from detaching from the guide slot 11.

[0054] Of course, in order to meet the requirement of smoothness of the catheter 10 when the system 100 passes through the blood vessel, Figure 1 and Figure 6 As shown, the catheter 10 has a distal end with an increased outer diameter, and may include a flexible catheter body 12 with a smaller outer diameter and a sleeve 13 with an increased outer diameter connected to the distal end of the catheter body 12. That is, when the catheter 10 passes through the blood vessel as a whole, the present invention ensures the smooth movement of the catheter 10 in the blood vessel by setting a catheter body 12 with a longer length and smaller size. Specifically, the sleeve 13 is connected to the catheter body 12 by a fixed connection method such as laser welding or glue bonding, so as to accommodate the cardiac anchor 20 and prevent the cardiac anchor 20 from causing damage to the surrounding tissues, and at the same time, it can also provide support and guidance for the cardiac anchor 20. The guide groove 11 is provided at the distal end of the catheter 10, such as the sleeve 13, and is axially cut along the side wall from the distal end opening of the sleeve 13 to the approximately proximal position of the sleeve 13 to form a guide groove 11 extending axially and having a width of W2.

[0055] Figure 7 The schematic diagram of the structure of the cardiac anchor in the first embodiment is shown, wherein the cardiac anchor 20a includes a locking assembly 21a and an anchor 22a, and the anchor 22a is connected to the distal end of the locking assembly 21a by rotation around the longitudinal axis of the locking assembly 21a. Further, the locking assembly 21a includes a main body 211a and a locking wire 212a rotatably connected to the main body 211a, and the medical wire 40 is located between the main body 211a and the locking wire 212a. In some embodiments, the locking assembly 21a also includes a connecting shaft 213a, and the locking wire 212a is connected to the main body 211a by rotation around the connecting shaft 213a. Under the axial actuation of the actuator 50, the locking wire 212a can rotate toward the main body 211a to press the medical wire 40 located between the main body 211a and the locking wire 212a onto the main body 211a.

[0056] Specifically, Figure 8-10 As shown, the anchor 22a includes a spiral coil 221a for engaging with cardiac tissue and a connecting member 222a disposed at the proximal end of the spiral coil 221a. An axially penetrating receiving channel 2110a is provided on the main body 211a. The connecting member 222a is at least partially rotatably received in the receiving channel 2110a and cannot be axially separated from the receiving channel 2110a. The spiral coil 221a includes a spiral segment 2211a having a sharp distal end for engaging with cardiac tissue and an axial connecting segment 2212a formed by transition from the proximal end of the spiral segment 2211a. The axial connecting segment 2212a is coaxially arranged with the spiral segment 2211a to ensure that the anchor 22a does not radially jump when anchored. The connecting member 222a is generally in the shape of a hollow tube, including a hollow inner cavity 2220a extending in the axial direction, for at least partially receiving the axial connecting segment 2212a of the spiral coil 221a. Furthermore, a mounting window 2111a communicating with the housing channel 2110a is provided at the side end of the housing channel 2110a, and the anchor 22a can be seen and installed in the housing channel 2110a through the mounting window 2111a. Fig. 9 As shown, after the axial connecting section 2212a of the spiral coil 221a is inserted from the distal end of the accommodating channel 2110a, and the connecting member 222a is inserted from the proximal end of the accommodating channel 2110a, at least the proximal end portion of the axial connecting section 2212a is inserted and fixed to at least the distal end portion of the hollow inner cavity 2220a of the connecting member 222a at the installation window 2111a. For example, an installation tool can be used to fix the two at the installation window 2111a by laser welding. Of course, other methods such as soldering, brazing, adhesives, etc. can also be used for fixing. Figure 9-10In order to ensure that the anchor 22a rotates circumferentially with the locking assembly 21a after installation, the two can also remain relatively fixed in the axial direction and inseparable, the present invention sets the accommodating channel 2110a to at least two sections with different inner diameters, including a proximal channel 2112a for accommodating at least part of the connecting member 222a and a distal channel 2113a for accommodating at least part of the axial connecting section 2212a. The proximal channel 2112a is connected to the distal channel 2113a to form the accommodating channel 2110a; and the diameter of the proximal channel 2112a is greater than the diameter of the distal channel 2113a, and its axial length is also greater than the axial length of the distal channel 2113a. At this time, the middle axial connecting section 2212a located between the spiral section 2211a and the connecting piece 222a is accommodated in the distal channel 2113a, and the spiral sections 2211a and the connecting piece 222a with larger radial dimensions on both sides axially restrict the middle axial connecting section 2212a with smaller diameter in the distal channel 2113a, thereby achieving axial inseparability of the anchor 22a relative to the locking assembly 21a.

[0057] Furthermore, in order to ensure that the anchor 22a and the driver 30 can be removably engaged, as shown in FIG. Figure 11-12 As shown, the proximal end of the connecting member 222a is also provided with a first releasing portion 2221a, and the distal end of the driver 30 is detachably connected to the first releasing portion 2221a. Specifically, the driver 30 includes a support member 31 and a releasing rod 32. The support member 31 is a hollow tube having a certain length. The releasing rod 32 is roughly in the shape of a slender rod, which is placed in the hollow cavity of the support member 31 and can be pulled and slid relative to the support member 31. The distal end of the support member 31 is provided with a second releasing portion 310 that is engaged with the first releasing portion. When the first releasing portion and the second releasing portion 310 are engaged, the releasing rod 32 is pushed and limited between the first releasing portion 2221a and the second releasing portion 310 to achieve the connection between the anchor 22a and the driver 30, and the release from each other is achieved by pulling out the releasing rod 32 to disengage the limit. In some embodiments, the first releasing portion 2221a and the second releasing portion 310 are snap-fitted. For example, it can be as follows Fig.12 The special-shaped buckles such as the S buckle, oblique buckle or toothed buckle shown can of course also be elastic buckles. In other embodiments, the first release portion 2221a and the second release portion 310 can also be directly configured as a threaded connection, such as a removable connection between an internal thread and an external thread, or a removable connection method such as magnetic attraction.

[0058] Specifically, Figure 13-14As shown, the main body 211a includes a main body end 2111 and a support end 2112 extending from the main body end 2111. The main body end 2111 is generally L-shaped, including a columnar body 2113 extending axially and a guide portion 210a formed by radially extending from the distal end of the body 2113. The accommodating channel 2110a axially penetrates the body 2113, and the installation window 2111a is arranged at the side end of the accommodating channel 2110a away from the guide portion 210a. The guide portion 210a is generally square, and a lug 2100a with increased width is formed at one end of the guide portion 210a away from the body 2113 and is arranged perpendicular to the guide portion 210a. The lug 2100a can abut against the outside of the guide groove 11 of the catheter 10 and follow the guide portion 210a to slide axially along the trajectory of the guide groove 11 (see Fig.15 ) to ensure that the radial position of the cardiac anchor 20a remains unchanged when it moves in the catheter 10. At the same time, it can also avoid the defect that when the locking wire member 212a rotates relative to the main body 211a to squeeze the medical wire 40, the overall radial position of the cardiac anchor 20a may be offset due to the squeezing force caused by the absence of the lug 2100a. In severe cases, this may cause the anchor 22a to be pulled out of the tissue and cause the risk of anchor failure.

[0059] The support end 2112 is used to support the locking member 212a so that the locking member 212a can be rotatably connected to the support end 2112. Specifically, the support end 2112 includes a main body 2114 connected to the body 2113 and a support portion 2115 extending from the main body 2114 in a direction close to the guide portion 210a. The main body 2114 extends circumferentially from the proximal end of the body 2113 and forms a disc shape. The disc-shaped main body 2114 axially extends in a direction close to the guide portion 210a to form two spaced support portions 2115. Two first shaft holes 2114a are symmetrically opened on the two support portions 2115 for pivoting with the locking member 212a using the connecting shaft 213a.

[0060] In addition, the wire locking member 212a is configured as a lever structure, including a wire pressing end 2121a, a driving end 2122a, and a connecting end 2123a connecting the wire pressing end 2121a and the driving end 2122a, wherein the wire pressing end 2121a and the driving end 2122a are respectively disposed on opposite sides of the connecting end 2123a. The connecting end 2123a is generally cylindrical, and the wire pressing end 2121a is protruded from one end of the cylindrical surface of the connecting end 2123a to cooperate with the main body end 2111 of the main body 211a to compress the medical wire 40; the driving end 2122a is protruded from the other end of the cylindrical surface of the connecting end 2123a to be removably engaged with the actuator 50. In some embodiments, in order to cooperate with the rotational connection with the main body 211a, a second axial hole 2120 that cooperates with the first axial hole 2114a is opened on the connecting end 2123a, and the connecting shaft 213a is used to pass through the first axial hole 2114a and the second axial hole 2120 to complete the pivotal connection between the main body 211a and the locking wire member 212a.

[0061] Of course, in order to ensure that the medical line 40 can be attached between the main body 211a and the locking wire member 212a, in some embodiments, such as Fig.16 As shown, the locking wire member 212a is provided with a first wire passage 2121 for the medical wire 40 to pass through. Specifically, the first wire passage 2121 is provided at a substantially central area of ​​the wire pressing end 2121a and axially passes through the wire pressing end 2121a. Figure 17-18 As shown, the main body 211a and the locking wire member 212a are respectively provided with a second wire passage 2115a and a first wire passage 2121 for the medical wire 40 to pass through. The second wire passage 2115a is provided at a position of the guide portion 210a adjacent to the lug 2100a, and is located between the guide portion 210a and the main body 2113, and can axially penetrate the guide portion 210a. The medical wire 40 enters from the second wire passage 2115a, and after passing through the second wire passage 2115a and the first wire passage 2121 in the horizontal direction, the whole medical wire 40 is horizontally passed through the cardiac anchor 20a, thereby realizing the rapid wire guiding operation of the medical wire 40 in the initial state of the system 100. That is, the longitudinal center axis of the first wire passage 2121 is roughly overlapped with the longitudinal center axis of the second wire passage 2115a, so that the axial horizontal wire guiding can be realized.

[0062] Continue reading Figure 17-18As shown, in order to improve the locking force of the medical wire 40 between the main body 211a and the locking wire member 212a, the main body end 2111 of the main body 211a is provided with a bearing surface 2116a extending in at least two directions, and the pressing end 2121a of the locking wire member 212a is provided with a pressing surface 2122 that matches the bearing surface 2116a. The medical wire 40 can be pressed onto the bearing surface 2116a by the pressing surface 2122 to form a lock extending in at least two directions. For example, the bearing surface 2116a is formed between the guide portion 210a of the main body end 2111 and the body 2113, and is as shown in FIG. Fig.17 The L-shaped extension shown is matched with the L-shaped pressing line surface 2122 to form a substantially L-shaped locking length, which can also be as shown in FIG. Fig.18 The U-shaped extension shown is matched with the U-shaped pressing surface 2122 and forms a generally U-shaped locking length, thereby improving the locking force of the cardiac anchor 20a and reducing the risk of the medical line 40 being detached.

[0063] Once the medical wire 40 is locked to the main body 211a by the locking wire member 212a, the cardiac anchor 20a needs to always keep the medical wire 40 locked to ensure that the cardiac anchor 20a can fix the medical wire 40 for a long time and keep it in the patient's body and maintain its effectiveness. Therefore, the cardiac anchor 20a of the present invention further includes a self-locking mechanism 214a, such as Figure 19-20 As shown, the self-locking mechanism 214a is disposed between the main body 211a and the locking member 212a to provide a certain resistance for releasing the locking state, thereby preventing the locking member 212a from rotating in the opposite direction and escaping from the locking state of the medical wire 40 due to heartbeat.

[0064] In some embodiments, Fig.19 As shown, the self-locking section with a changing curvature radius is designed between the main body 211a and the locking wire member 212a to cooperate with the inclined surface to form a self-locking mechanism 2141a. Specifically, as Fig.13 , 14 As shown in Figures 19 and 20, the self-locking mechanism 2141a includes a self-locking section 21411, a retaining member 21412 and an elastic member 21413. The self-locking section 21411 is disposed on the locking member 212a, and may be, for example, an arc-shaped outer surface with a gradually changing radius of curvature on the connecting end 2123a; the retaining member 21412 is movably disposed on the main body 211a and has a self-locking inclined surface 21414 that can cooperate with the self-locking section 21411, and the elastic member 21413 is compressed between the main body 211a and the retaining member 21412. When the system 100 is in the initial state and the anchoring completion state, the cardiac anchor 20a is always kept in the unlocked state. At this time, as shown in FIG. Fig.19As shown in a, the first position of the self-locking inclined surface 21414 abuts and is maintained at the first position of the self-locking segment 21411. Under the actuation of the actuator 50, the locking member 212a rotates relative to the main body 211a in a direction away from the self-locking inclined surface 21414. At this time, the self-locking segment 21411 is separated from the abutment of the self-locking inclined surface 21414 due to the reduction of the curvature radius. Then, under the action of the elastic restoring force of the elastic member 21413, the retaining member 21412 moves on the main body 211a toward the locking member 212a until the cardiac anchor 20a switches to the locking state; in this locking state, as shown in FIG. Fig.19 As shown in FIG. 2 , at this time, the second position of the self-locking inclined surface 21414 abuts and remains at the second position of the self-locking section 21411, and the elasticity of the elastic member 21413 is partially or completely released. The curvature radius R1 of the self-locking section 21411 at the first position is greater than the curvature radius R2 at the second position, and the first position of the self-locking inclined surface 21414 is lower than the second position of the self-locking inclined surface 21414. In some embodiments, the self-locking section 21411 is a partially arc-shaped outer contour line or arc-shaped outer surface with a gradually decreasing curvature radius from the connecting end 2123a. For example, the outer contour or outer surface of the connecting end 2123a can be designed as a section of an Archimedean spiral, or as a section of an involute. In other words, when locking the wire, the curvature radius of the self-locking section 21411 changes from large to small, and the retaining member 21412 is displaced in the direction close to the locking wire member 212a under the action of the elastic member 21413 and completes the self-locking function. In this way, when the heart beats and drives the medical wire 40 to react on the locking wire piece 212a in the locking state, the locking wire piece 212a tends to reverse in the direction close to the self-locking inclined surface 21414, but because the curvature radius of the self-locking section 21411 changes from small to large, the locking wire piece 212a with a reversal tendency will produce a greater squeezing force on the retaining piece 21412, and the squeezing force further causes the retaining piece 21412 to produce a greater force on the main body 211a, thereby increasing the friction between the main body 211a and the retaining piece 21412. That is, at this time, the elastic force of the elastic member 21413 and the friction force of the self-locking slope 21414 on the self-locking section 21411 need to be overcome to complete the unlocking. Therefore, the required driving force will be greatly increased, which can effectively prevent the self-locking function from failing due to the beating of the heart. It not only improves the reliability of the self-locking function of the locking wire member 212a, but also ensures the long-term locking of the medical wire 40 by the self-locking mechanism 2141a.

[0065] Furthermore, if Fig.13 and 19As shown, the retaining member 21412 includes a wedge block 21415 and a guide post 21416 connected to the proximal end of the wedge block 21415, and the elastic member 21413 is sleeved on the guide post 21416 and axially compressed between the wedge block 21415 and the main body 2114 of the main body 211a. Specifically, the self-locking inclined surface 21414 is arranged on the wedge block 21415 and is arranged opposite to the guide post 21416, that is, the self-locking inclined surface 21414 gradually increases from the distal end to the proximal end of the wedge block 21415. The elastic member 21413 can be a spring (not shown) or an arc-shaped spring sheet. An axially extending guide groove 2117 is provided in the approximate center area of ​​the main body 2114 located above the main body 2113. The two ends of the elastic member 21413 respectively abut against the wedge block 21415 and the main body 2114. The guide column 21416 axially penetrates the elastic member 21413 and is at least partially accommodated in the guide groove 2117 and can move axially relative to the guide groove 2117.

[0066] Furthermore, the main body 211a has a guide sliding surface 2119, and the retaining member 21412 is slidably disposed on the guide sliding surface 2119 and abuts against the self-locking section 21411 of the thread locking member 212a. Since the guide sliding surface 2119 is a smooth horizontal surface, the angle between the self-locking inclined surface 21414 of the retaining member 21412 and the guide sliding surface 2119 is the inclination angle of the wedge block 21415.

[0067] In other embodiments, Fig. 20 As shown, the main body 211a and the locking wire member 212a are meshed and matched to form a self-locking mechanism 2142a. Specifically, a plurality of first meshing teeth are provided on the main body 211a, and a second meshing tooth for meshing with the first meshing teeth is provided on the connecting end 2123a of the locking wire member 212a. The locking wire member 212a can be kept in a locked wire state to form a self-locking under the meshing cooperation of the second meshing teeth and the first meshing teeth, thereby ensuring the long-term stability of the locking of the cardiac anchor 20a and effectively preventing the defect of the medical line 40 from loosening.

[0068] In order to ensure the removable engagement of the actuator 50 with the driving end 2122a, as Fig.13 and 21As shown, the driving end 2122a has a joint 21220, the distal end of the actuator 50 is removably joined to the joint 21220, and the proximal end of the actuator 50 extends through the catheter 10 until it is connected to the actuating mechanism of the proximal handle 60 for the operator to operate. Therefore, under the control of the operator, the actuator 50 is axially actuated toward the proximal end in a substantially horizontal direction, and the driving end 2122a can generate torque under the axial actuation of the actuator 50 to rotate around the connecting shaft 213a, so that the defects of excessive anchoring or anchoring failure caused by the direction of executing the locking line being the same as the direction of anchoring in the prior art will not occur. Specifically, the driving end 2122a includes two rod bodies 21221 that are convexly arranged side by side at the connecting end 2123a and are spaced apart, and the joint 21220 can be a winding shaft 21222 with a smooth outer surface, and the winding shaft 21222 is connected between the two rod bodies 21221 and is arranged away from the wire pressing end 2121a. In some embodiments, the actuator 50 is a flexible traction member, which can be removably engaged with the winding shaft 21222 by winding the distal end back to the winding shaft 21222.

[0069] Of course, in order to further avoid the risk of the flexible traction member 50 detaching from the outer surface of the winding shaft 21222 and causing actuation failure, as shown in FIG. Fig.21 As shown in FIG. 1 , the joint 21220 further includes an anti-slip shaft 21223, which is disposed between the two rod bodies 21221 and adjacent to the winding shaft 21222. A gap S is formed between the anti-slip shaft 21223 and the winding shaft 21222, so that the flexible traction member 50 can further pass through the gap S when it is wound around the outer surface of the winding shaft 21222. At the same time, in order to reduce the actuation force required to actuate the locking member 212a to a certain extent to achieve the purpose of labor saving, as shown in FIG. Fig.21 As shown in b, the distance from the winding shaft 21222 to the longitudinal center axis of the second axial hole 2120 is greater than the distance from the wire pressing surface 2122 to the longitudinal center axis of the second axial hole 2120.

[0070] It is understandable that, since the medical wire 40 needs to be squeezed and locked, the main body 211a, the locking wire member 212a and the connecting shaft 213a are designed to be rigidly connected to each other, and the materials can be stainless steel, pure titanium and titanium alloy, etc.; while the medical wire 40 is generally a flexible polymer material. Therefore, when the medical wire 40 passes through the first wire passage 2121 of the locking wire member 212a or passes through the second wire passage 2115a of the main body 211a and the first wire passage 2121 of the locking wire member 212a, the medical wire 40 will be in direct contact with the main body 211a and the locking wire member 212a, which will cause wear to the medical wire 40 when the system 100 enters the heart, when the medical wire 40 is adjusted, and when the heart beats, and then cause irreversible damage to the medical wire 40, resulting in the medical wire 40 not meeting the fatigue performance and being easy to break, and ultimately leading to surgery failure. In order to protect the medical wire 40 and improve the fatigue performance of the medical wire 40, the system 100 of the present invention further includes a buffer 70, which is disposed on at least a portion of the surface of the wire passage through which the medical wire 40 passes, so as to reduce the hardness of the surface of the wire passage. Fig. 22 As shown, the buffer member 70 can be a coating coated on the surface of the wire-passing channel with a hardness lower than that of the main member 211a and / or the wire-locking member 212a, or can be a hollow coating or flexible member that penetrates the wire-passing channel for the medical wire 40 to pass through, and the coating or flexible member at least covers the surface of the wire-passing channel. The flexible member can be a cloth sleeve or a flexible wire, for example, the cloth sleeve can be fixed to the surface of the first wire-passing channel 2121 and / or the surface of the second wire-passing channel 2115a by bonding or suturing with an adhesive (epoxy resin), or the flexible wire can be wrapped to cover the surface of the wire-passing channel. The present application is described by taking the cloth sleeve 70 as an example, and the cloth sleeve 70 is made of a material with a lower hardness than that of the main member 211a and / or the wire-locking member 212a, such as a polymer material. At this time, the medical wire 40 made of the polymer material is locked into the cloth sleeve 70 made of the polymer material, and the friction between the two is also improved, thereby further improving the fatigue performance of the medical wire 40. Of course, in order to avoid the risk of wrinkles on the cloth cover 70 after locking, which may lead to a decrease in the locking force on the medical wire 40, the outer diameter of the cloth cover 70 is slightly smaller than the inner diameter of the wire passage of the cardiac anchor 20a.

[0071] Figure 23-24 FIG. 2 shows an unlocked state diagram and a locked state diagram of the cardiac anchor 20a. When the cardiac anchor 20a is in the unlocked state, as shown in FIG. Fig.23As shown, the anchoring member 22a is rotatably connected to the main body 211a, the pressing end 2121a is positioned on the main body 211a in the vertical direction, and is located on the same side of the main body 2113 as the guide portion 210a and is substantially parallel to the guide portion 210a; the engaging portion 21220 of the driving end 2122a is located on the other side of the main body 2113 and is positioned substantially below the guide portion 210a, and the engaging portion 21220 is disposed away from the supporting end 2112. After the distal end of the actuator 50 is removably engaged to the engaging portion 21220, the actuator 50 can be axially extended in a substantially horizontal direction to the actuating mechanism of the proximal handle 60, so that the operator can axially actuate the actuator 50 to generate torque at the driving end 2122a. In addition, the free end of the medical wire 40 horizontally passes through the cloth cover 70 to pass through the second wire passage 2115a and the first wire passage 2121; at this time, the inner diameter of the cloth cover 70 is larger than the diameter of the medical wire 40, and the medical wire 40 can slide freely in the cloth cover 70. When the actuator 50 is actuated to actuate the locking member 212a to lock the medical wire 40, the cardiac anchor 20a can be switched to Fig.24 The wire locking state shown. Specifically, the actuator 50 is pulled proximally to actuate the engagement portion 21220 of the driving end 2122a to rotate proximally to a position adjacent to the support end 2112, that is, the distal end of the locking assembly 21a moves along a substantially axial direction to the proximal end of the locking assembly 21a. Driven by the driving end 2122a, the wire pressing end 2121a moves toward the direction of the bearing surface 2116a, and utilizes the wire pressing surface 2122 to compress and deform the medical wire 40 and the cloth cover 70 onto the bearing surface 2116a to form a wire locking length that is roughly L-shaped or U-shaped. At the same time, the self-locking mechanism 214a also moves relative to each other under the drive of the driving end 2122a and continuously maintains the wire locking member 212a in the wire locking state.

[0072] Of course, in order to ensure that the joint 21220 can effectively move in the catheter 10, as shown in FIG. Figure 2-4 and Figure 6 As shown, the side wall of the catheter 10 is also provided with an active channel 14 for the driving end 2122a to move, and the active channel 14 is arranged opposite to the guide groove 11 of the catheter 10. For example, the side wall is cut from the position adjacent to the distal end of the sleeve 13 to the position adjacent to the proximal end of the sleeve 13 to form a closed active channel 14. The closed active channel 14 is not only used for the driving end 2122a to move freely Figure 2 The first position shown is movable to Figure 3The second position shown is further used to limit the problem that the cardiac anchor 20a falls out of the distal end of the catheter 10 due to excessive anchoring during the anchoring process. Specifically, when the system 100 is in the initial state, the cardiac anchor 20a is located in the first position in the catheter 10, and the joint 21220 of the driving end 2122a is located in the proximal region of the active channel 14. When the system 100 switches from the initial state to the anchoring completion state, the cardiac anchor 20a shifts from the first position to the second position. At this time, the joint 21220 can be limited by the distal end of the active channel 14 to abut against the distal end of the active channel 14, thereby avoiding the risk of the cardiac anchor 20a falling out of the distal end of the catheter 10 due to excessive anchoring. Of course, the active channel 14 is also used for the driving end 2122a to move from its distal end to the proximal region when implementing the locking line. Figure 4 Proximal end shown.

[0073] Figure 25-32 A schematic diagram of the system 100 entering the mitral valve through an intravascular catheter to implant artificial chordae in some embodiments is shown. The system 100 can complete the implantation of artificial chordae of the mitral valve, thereby preventing mitral valve regurgitation. In order to ensure that the catheter 10 can reach the target position inside the heart along the expected path, the system 100 can also include a delivery sheath 80, which provides a path from outside the body to enter the heart, so that the catheter 10 can enter the target position inside the heart through the path. Specifically, the delivery sheath 80 is a slender flexible catheter, which enters the right atrium 82 inside the heart by inserting the distal end into the femoral vein at the patient's groin and advancing to the inferior vena cava 81. After puncturing the atrial septum 83 inside the heart with a suitable puncture tool, the distal end of the delivery sheath 80 will further enter the left atrium 84 through the atrial septum 83 to position its distal opening at the mitral valve position of the left atrium 84. Of course, in order to ensure that the system 100 can smoothly pass through the complex human vascular system to reach the target position inside the heart, the catheter 10 can cooperate with the delivery sheath 80 sleeved outside the catheter 10 to achieve multi-stage bending. In some embodiments, the delivery sheath 80 has at least two bending sections, and the catheter 10 has at least one bending section, such as disposed at the proximal end of the sleeve 13 or the distal end of the catheter body 12, to achieve at least three levels of bending function of the system 100.

[0074] Then, after completing the transcatheter leaflet suturing operation to fix one end of the medical wire 40 to the leaflet end, the other end (i.e., the free end) of the medical wire 40 will be led out of the delivery sheath 80 to the outside of the body; at this time, the operator first needs to introduce the free end of the medical wire 40 from the wire channel or cloth sleeve 70 of the heart anchor 20a into the catheter 10 outside the body, and pass through the catheter 10 until it is led out of the handle 60. At this time, the system 100 is in an initial state, and the heart anchor 20a is located at the first position in the catheter 10. Next, the medical wire 40 is kept appropriately tensioned, and the distal end of the catheter 10 is uniformly advanced along the path of the delivery sheath 80 and the medical wire 40 into the ventricle of the mitral valve; at this time, the distal end of the catheter 10 has a bending section, and the bending mechanism (not shown) of the control handle 60 is actuated to actuate the bending section of the catheter 10, thereby bending the distal end of the catheter 10, which is roughly parallel to the atrial septum 83 and is delivered to the ventricle, to a direction roughly perpendicular to the ventricular tissue, such as the papillary muscle, and further placing the distal end opening of the catheter 10 close to the target position of the papillary muscle, such as Fig.25 shown.

[0075] In some embodiments, in order to prevent the anchor 22a from slipping out of the target position due to the excessive smoothness of the papillary muscle during the process of anchoring the anchor 22a into the papillary muscle, thereby causing the anchor position of the anchor 22a to deviate from the target position, such as Fig.26 As shown, the system 100 also includes a positioning needle 90, which is removably carried in the cloth cover 70 and extends proximally through the catheter 10 to the positioning needle movement mechanism of the proximal handle 60 (not shown); if there is no cloth cover 70, the positioning needle 90 is removably carried in the wire passage of the cardiac anchor 20a. Specifically, the positioning needle 90 is a slender member with a sharp distal end, and the distal end of the positioning needle 90 can be pre-carried in the cloth cover 70 or the wire passage together with the medical line 40. Therefore, when the distal end of the catheter 10 is abutted, the positioning needle movement mechanism of the control handle 60 is used to push the positioning needle 90 toward the distal end, and then the positioning needle 90 is pushed out from the distal opening of the catheter 10 and penetrates into the papillary muscle, as shown in FIG. Fig. 27 As shown; at this time, the positioning needle 90 can resist the rotational force transmitted from the catheter 10 to maintain the position of the anchor 22a to ensure stability when the anchor 22a is implanted.

[0076] When the positioning needle 90 is positioned, the driving mechanism of the control handle 60 is used to drive the anchor 22a to be spirally pushed out from the distal opening of the catheter 10 through the driver 30 to anchor it to the target position of the papillary muscle. Figure 3 and 28As shown; at this time, the anchor 22a is inserted in a direction roughly perpendicular to the papillary muscle, the cardiac anchor 20a is displaced from the first position in the catheter 10 to the second position, and the locking assembly 21a also follows the anchor 22a and axially displaces to the second position along the trajectory of the guide groove 11. Then, the positioning needle movement mechanism of the control handle 60 is used to withdraw the positioning needle 90 from the cloth cover 70, so that the operator can control the medical wire 40 in the cloth cover 70; after the free end of the medical wire 40 is pulled outside the body to adjust the medical wire 40 between the leaflet and the papillary muscle to an appropriate tension to achieve the best valve function, the actuator 50 is pulled axially proximally to drive the locking wire member 212a to rotate relative to the main body 211a to squeeze and compress the medical wire 40 and the cloth cover 70 to the main body 211a, as shown in FIG. Fig.29 As shown, at this time, the main body 211a remains fixed in the second position, and the thread locking member 212a rotates, so that the main body 211a cannot be affected by the thread locking process, thereby ensuring the stability of the anchor member 22a. Once the thread locking is completed, the actuating mechanism of the operating handle 60 is used to withdraw the actuator 50, as shown in FIG. Fig.30 further operating the driving mechanism of the handle 60 to drive the second release portion 310 of the driver 30 to disengage from the first release portion 2221a of the anchor member 22a, such as Fig.31 Finally, the whole is withdrawn to leave the cardiac anchor 20a and the medical line 40 in the human body, as Fig.32 As shown; then, a cutting device (not shown) is introduced into the proximal end of the cardiac anchor 20a along the path of the delivery sheath 80 and the medical wire 40 outside the body, and the medical wire 40 is cut at the proximal end of the cardiac anchor 20a to leave a suitable tail wire at the cardiac anchor 20a. Once the cutting is completed, the cutting device is withdrawn. At this time, the medical wire 40 after cutting will be formed between the leaflets of the heart valve and the ventricular tissue to form an artificial tendon, thereby replacing or supplementing the natural tendon of the heart to achieve the best valve function.

[0077] Figure 33-35The schematic diagram of the structure of the cardiac anchor in the second embodiment is shown, wherein the cardiac anchor 20b includes a locking assembly 21b and an anchor 22b, and the anchor 22b is connected to the locking assembly 21b by rotation around the longitudinal axis of the locking assembly 21b. Further, the locking assembly 21b includes a main body 211b and a locking wire member 212b axially elastically connected to the main body 211b, and the medical line 40 is located between the main body 211b and the locking wire member 212b. The actuator 50 is used to engage with the locking wire member 212b to actuate the locking wire member 212b to axially move in a direction close to the main body 211b and lock the medical line 40. Specifically, the locking assembly 21b also includes an elastic element 213b, which is stretched axially between the main body 211b and the locking wire member 212b, and the medical line 40 can pass through a partial spiral section of the elastic element 213b. When the actuator 50 is actuated, such as releasing the locking wire member 212b, the locking wire member 212b can be axially displaced toward the main body 211b under the elastic restoring force of the elastic element 213b to clamp the medical wire 40 between the main body 211b and the locking wire member 212b to the elastic element 213b.

[0078] In some embodiments, Fig.34As shown, the main body 211b and the locking wire member 212b are respectively provided with a first accommodating channel 2110b and a second accommodating channel 2120b which are axially connected, and at least the proximal portion of the anchor member 22b is rotatably accommodated in the first accommodating channel 2110b and the second accommodating channel 2120b. The first accommodating channel 2110b and the second accommodating channel 2120b are configured as two sections with different inner diameters, so that the anchor member 22b is axially restricted but rotatably connected in the accommodating channel. Specifically, the main body 211b and the locking wire member 212b are both roughly disc-shaped, and the first accommodating channel 2110b and the second accommodating channel 2120b are respectively arranged at the approximate center positions of the main body 211b and the locking wire member 212b. Furthermore, the anchor 22b includes a spiral coil 221b for engaging with cardiac tissue and a connector 222b disposed at the proximal end of the spiral coil 221b, wherein the spiral coil 221b includes a spiral segment 2211b having a sharp distal end and engaging with cardiac tissue and an axial connector 2212b formed by transitioning from the proximal end of the spiral segment 2211b. The axial connector 2212b is coaxially arranged with the spiral segment 2211b to ensure that the anchor 22b does not radially jump when anchored. The connector 222b is generally in the shape of a hollow tube and has a hollow inner cavity 2220b extending in the axial direction, wherein the hollow inner cavity 2220b has two sections of inner cavities with varying radial dimensions, and the radial dimension of the distal inner cavity is smaller than the diameter of the radial dimension of the proximal inner cavity, so that the axial connector 2212b can be accommodated in the distal inner cavity of the hollow inner cavity 2220b to achieve a fixed connection between the two. It can be understood that the inner diameter of the first accommodating channel 2110b is slightly larger than the outer diameter of the axial connecting section 2212b, so that the axial connecting section 2212b can be rotatably arranged in the first accommodating channel 2110b; the inner diameter of the second accommodating channel 2120b is slightly larger than the outer diameter of the connecting member 222b, so that the connecting member 222b can be at least partially rotatably arranged in the second accommodating channel 2120b. Fig.35 As shown, the proximal end of the axial connecting section 2212b is fixedly connected to the distal inner cavity of the hollow inner cavity 2220b of the connecting piece 222b after passing through the first accommodating channel 2110b, for example, by laser welding or glue bonding. At this time, after the connecting piece 222b passes through the second accommodating channel 2120b, its distal end abuts against the proximal side of the main body 211b, and its proximal end is exposed outside the proximal end of the locking wire piece 212b. The elastic element 213b is axially sleeved outside the connecting piece 222b, and its two ends are fixedly connected to the main body 211b and the locking wire piece 212b respectively by welding or glue bonding; wherein, there is a gap between the elastic element 213b and the connecting piece 222b to facilitate the medical line 40 to pass through the gap to complete the lead. Of course, in other embodiments, the cardiac anchor 20b may also be provided with a transition piece 214b, where the transition piece 214 is provided in the first accommodating channel 2110b to isolate the direct contact between the spiral coil 221b and the main body 211b.

[0079] Furthermore, the first guide portion 210b and the second guide portion 210b' are symmetrically arranged by radially extending from the side ends of the main body 211b and the locking member 212b. The first guide portion 210b and the second guide portion 210b' are roughly square in shape. The first lug 2100b with increased width is formed at one end of the first guide portion 210b away from the disc-shaped body of the main body 211b, and the second lug 2100b' with increased width is formed at one end of the second guide portion 210b' away from the disc-shaped body of the locking member 212b. The first lug 2100b is roughly perpendicular to the first guide portion 210b, and the second lug 2100b' is roughly perpendicular to the second guide portion 210b'. Both the first lug 2100b and the second lug 2100b' can abut against the outside of the guide groove 11 of the catheter 10 and slide axially along the trajectory of the guide groove 11 (see Fig.36 ), to ensure that the radial position of the cardiac anchor 20b remains unchanged when it moves in the catheter 10. Of course, the catheter 10 can also be a slender tube structure with a variable diameter, including a catheter body 12 and a sleeve 13. For details, please refer to the first embodiment, which will not be repeated here.

[0080] In some embodiments, the first guide portion 210b has a first wire-passing channel 2111b axially extending through the position adjacent to the first lug 2100b, and the second guide portion 210b' has a second wire-passing channel 2121b axially extending through the position adjacent to the second lug 2100b'. After the medical wire 40 enters the gap between the main body 211b and the locking wire member 212b from the first wire-passing channel 2111b, it passes through a part of the spiral section of the elastic element 213b or several spiral sections of the elastic element 213b are passed through at intervals, and further extends through the second wire-passing channel 2121b of the locking wire member 212b, and then extends from the catheter 10 to the outside of the proximal end of the handle 60. Of course, the wire-passing channel can be provided only in the main body 211b or only in the locking wire member 212b, or the main body 211b and the locking wire member 212b are not provided with a wire-passing channel, and the medical wire 40 is locked by the elastic element 213b.

[0081] like Fig.34 and 38 As shown, in order to ensure that the anchor 22b and the driver 30 are removably engaged, the proximal end of the connecting member 222b is provided with a first release portion 2221b, and the distal end of the driver 30 is provided with a second release portion 310 detachably connected to the first release portion 2221b. Fig.34 and 35As shown, in order to ensure that the locking assembly 21b and the actuator 50 are removably engaged, the proximal end of the locking wire member 212b is provided with a third release portion 2122b, and the distal end of the actuator 50 is provided with a fourth release portion 500 detachably connected to the third release portion 2122b. The connection structure between the first release portion 2221b and the second release portion 310, and the connection structure between the third release portion 2122b and the fourth release portion 500 can be specifically referred to the first embodiment, the first release portion 2221b and the second release portion 310 are preferably connected by an oblique buckle, and the third release portion 2122b and the fourth release portion 500 are preferably connected by a thread.

[0082] When the system 100 is in an initial state, such as Fig.37 As shown. At this time, the cardiac anchor 20b is carried in the first position of the catheter 10, and the locking assembly 21b is circumferentially limited in the catheter 10 by the first lug 2100b and the second lug 2100b', and the anchor 22b is rotationally connected to the distal end of the locking assembly 21b. The locking wire member 212b is tightened and locked to the actuating mechanism of the handle 60 by the actuator 50 connected thereto; at this time, the elastic element 213b is continuously in a stretched state; the medical wire 40 enters from the first wire channel 2111b and passes through the middle part of the spiral section of the elastic element 213b, and then passes through the second wire channel 2121b until it extends outside the handle 60. After the lead-in is completed, the medical wire 40 can be pulled to move freely at the locking assembly 21b. During anchoring, the driving mechanism at the proximal end of the handle 60 is manipulated to actuate the driver 30 to drive the anchor 22b to spirally advance, so as to drive the cardiac anchor 20b to self- Fig.37 The first position shown is displaced distally to Fig.38 In the second position shown, the anchor 22b can be pushed out from the distal end of the catheter 10 to anchor into the heart tissue, and the locking assembly 21b is circumferentially limited by the catheter 10 and axially displaced to the second position in the catheter 10. In the second position, the system 100 is in a state where the cardiac anchor 20b is anchored.

[0083] Once the cardiac anchor 20b is anchored, the proximal end of the medical wire 40 is pulled outside the body to adjust the medical wire 40 to an appropriate tension to achieve optimal valve function. Fig.39 As shown, the actuating mechanism of the operating handle 60 is operated to release the lock of the actuator 50. At this time, the fourth release portion 500 of the actuator 50 is disengaged from the third release portion 2122b, and the elastic element 213b will return to its original state under the action of the elastic restoring force, and drive the locking wire member 212b to move axially along the guide groove 11 toward the main body 211b to clamp the medical wire 40 passed through the elastic element 213b; at this time, the medical wire 40 can be maintained under the appropriate tension.

[0084] It is understandable that the cardiac anchors 20a and 20b can be used not only in the field of artificial chord implantation, but also in the fields of annuloplasty, edge-to-edge repair and ventricular reconstruction, so as to fix the medical wire 40 to the inside of the heart tissue to repair heart function.

[0085] The above is an implementation method of the embodiment of the present invention. It should be noted that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention. The above is an implementation method of the embodiment of the present invention. It should be noted that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A system for deploying a cardiac anchor, characterized in that: The system comprises: a catheter having a distal end and a proximal end; a cardiac anchor carried in the catheter, the cardiac anchor comprising a locking assembly and an anchor rotatably connected to a distal end of the locking assembly, the locking assembly being attached with a medical wire; and an actuator carried within the catheter, the actuator engaging the anchor and extending proximally through the catheter; The driver is used to spirally advance the anchor to drive the heart anchor to move from the first position of the catheter to the second position of the catheter, the anchor is spirally pushed out from the distal end of the catheter to anchor into the heart tissue, and the locking assembly is circumferentially limited by the catheter and axially shifted to the second position to lock the medical wire at the second position.

2. The system according to claim 1, characterized in that An axially extending guide groove is provided on the side wall of the conduit, and the locking assembly has a guide portion, at least a portion of the guide portion is circumferentially confined in the guide groove and can move axially along the guide groove.

3. The system according to claim 2, characterized in that The catheter has a distal end with an increased outer diameter, and the guide groove is arranged at the distal end of the catheter.

4. The system according to claim 2, characterized in that One end of the guide portion extending out of the guide groove is formed with a positioning end with an increased width, and the positioning end abuts against the outside of the guide groove and can move axially along the guide groove.

5. The system according to claim 4, characterized in that A wire passage axially passes through the guide portion adjacent to the positioning end, and the medical wire enters the catheter from outside the guide groove to pass through the wire passage.

6. The system according to claim 1, characterized in that The system also includes an actuator carried in the catheter, the actuator being engaged with the locking assembly; in the second position, the actuator actuates the locking assembly in a non-helical advancement manner to lock the medical wire and maintain it under appropriate tension.

7. The system according to claim 6, characterized in that The locking assembly includes a main body and a locking wire member movably connected to the main body, and the medical wire is attached between the main body and the locking wire member; the actuator is engaged with the locking wire member to actuate the locking wire member to move relative to the main body and lock the medical wire.

8. The system according to claim 7, characterized in that The anchoring member includes a spiral coil and a connecting member arranged at the proximal end of the spiral coil, and the spiral coil is used to engage with the heart tissue; the main body and / or the locking wire member are provided with an axially through-going accommodating channel, and the connecting member is at least partially rotatably accommodated in the accommodating channel.

9. The system according to claim 8, characterized in that The accommodating channel has at least two sections with different inner diameters, so that the anchoring member can be axially restricted but rotationally connected in the accommodating channel.

10. The system according to claim 7, characterized in that The main body and / or the wire locking member are provided with a wire passage for the medical wire to pass through. The system further comprises a buffer member, which is disposed on at least a portion of the surface of the wire passage to reduce the hardness of the surface of the wire passage.

11. The system according to claim 10, characterized in that The buffer component includes a coating applied on the surface of the wire-passing channel, or a coating or a flexible component covering the surface of the wire-passing channel.

12. The system according to claim 10, characterized in that The system further includes a positioning needle which is removably carried in the wire passage or in the buffer and extends proximally through the catheter.

13. The system according to claim 7, characterized in that The wire locking member is rotatably connected to the main body and has a driving end engaged with the actuator. A movable channel for the driving end to move is opened on the side wall of the conduit.

14. The system of claim 13, wherein: A self-locking mechanism is provided between the main body and the wire locking member.

15. The system of claim 7, wherein: The locking assembly also includes an elastic element located between the main body and the locking wire element, and the medical wire is passed through a partial spiral section of the elastic element; the locking wire element is released by the actuator and axially shifted toward the main body under the action of the elastic element to clamp the medical wire to the elastic element.

16. The system of claim 6, wherein: The system further comprises a handle disposed at the proximal end of the catheter, and the driver and the actuator extend proximally through the catheter and are connected to the handle.

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