System for deploying cardiac anchors

Abstract

The present invention provides a system for deploying a cardiac anchor, comprising a catheter, a cardiac anchor carried in the catheter, and a driver. The cardiac anchor comprises a locking assembly and an anchor rotatably connected to the locking assembly, the locking assembly being attached with a medical wire, and the driver being engaged with the anchor and extending proximally through the catheter. The driver is used to spirally propel the anchor to drive the cardiac anchor from a first position of the catheter to a second position; at this time, the anchor can be spirally pushed out from the distal end of the catheter to anchor into cardiac tissue, and the locking assembly is circumferentially limited by the catheter and axially displaced to a second position for the locking assembly to lock the medical wire in the second position. This system 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 advantageously ensuring the success rate of the 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. Mitral regurgitation is one of the most common valvular diseases and seriously threatens the life of patients. The mitral valve is a one-way valve connecting the left atrium and the left ventricle. It includes structures such as the valve annulus, anterior leaflet, posterior leaflet, chordae tendineae, and papillary muscles. When the heart is in diastole, the anterior and posterior leaflets open, and blood flows from the atrium to the ventricle; when the heart is in diastole, blood flows from the ventricle to the aorta, and the anterior and posterior leaflets are completely closed under the traction of the chordae tendineae to prevent blood from flowing back from the ventricle to the atrium. However, when the relevant structures of the mitral valve are diseased, such as chordal disease or rupture, resulting in leaflet prolapse or annular dilatation, the anterior and posterior leaflets will not be able to completely close during systole, 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 chordae tendineae disease or rupture, the existing technology usually adopts the method of artificial chordae tendineae implantation to replace the diseased or broken chordae tendineae in order to achieve the purpose of repair. Based on the structural principle of the native chordae tendineae, it is generally necessary to use a suturing device to fix one end of the artificial chordae tendineae to the valve leaflet end, and use an anchoring device to fix the other end of the artificial chordae tendineae to the ventricular end or papillary muscle to complete the implantation of the artificial chordae tendineae. The existing technology discloses an anchoring device, which includes a spiral nail for anchoring into the tissue and a locking wire part for locking the artificial chordae tendineae, 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 chordae tendineae are very likely to be tangled or twisted. Specifically, the existing technology generally passes the artificial tendon through the spiral nail and the locking wire part at the same time to avoid the problem of twisting the wire. However, there is a risk that the sharp end of the spiral nail may scratch the artificial tendon and cause the artificial tendon to be damaged or broken; and in the process of winding the artificial tendon around the spiral nail, there is a risk that the artificial tendon will be entangled with the spiral nail due to incomplete winding or excessive winding, which may cause the artificial tendon to be unable to achieve the adjustment function after anchoring, resulting in the serious consequence of failure of the artificial tendon implantation. Summary of the Invention

[0004] The purpose 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 medical wire wear, tangling and twisting, but also further ensure the adjustment function of the medical wire, thereby ensuring the success rate of the operation.

[0005] To achieve the above objectives, 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 cardiac 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 is such that when the anchor moves in the catheter in a spirally advanced manner, the locking assembly can achieve axial displacement relative to the catheter under the joint action of the anchor and the catheter, thereby causing the medical wire attached to the locking assembly to only undergo 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 following briefly introduces the drawings required for use in the embodiments. 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 any 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 Shown Figure 1 The system shown is in an initial state.

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

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

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

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

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

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

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

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

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

[0023] Figure 14 Shown Figure 13 Side view of the main body.

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

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

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

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

[0028] Figure 23-24 Schematic diagrams showing the locking assembly with a cloth cover in an initial state and a thread locking state.

[0029] Figure 25 Shows that it will have Figure 7Schematic diagram of a cardiac anchor system shown being deployed intraventricularly to the mitral valve via a transcatheter approach.

[0030] Figure 26 The positioning pin is shown to be set at Figure 25 A side cutaway view of the system is shown.

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

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

[0033] Figure 29 Schematic diagram showing the completion of cardiac anchor lockwire.

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

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

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

[0037] Figure 35 Shown Figure 33 Side cross-sectional view of the mid-heart anchor.

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

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

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

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

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

[0043] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only 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 refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be implemented. Directional terms mentioned in the present invention, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are merely references to the directions in the accompanying drawings. Therefore, the directional terms used are intended to better and more clearly illustrate and understand the present invention, and are not intended to indicate or imply that the device or component referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0045] It should be noted that, to more clearly describe the system for deploying a cardiac anchor provided by the present invention, the defined terms "proximal" and "distal" used in this specification are commonly used in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during a surgical procedure, while "proximal" refers to the end closer to the operator during a surgical procedure. The direction of the central axis of rotation of an object such as a cylinder or tube is defined as the axial or longitudinal axis; the circumferential direction is the direction around the axis of the object such as a cylinder or tube (perpendicular to the axis and also perpendicular to the cross-sectional radius); and the radial direction is the direction along the diameter or radius. It is worth noting that the term "end" as used in terms such as "proximal," "distal," "one end," "other end," "first end," "second end," "initial end," "terminal end," "both ends," "free end," "upper end," and "lower end" is not limited to a tip, endpoint, or end face, but also includes a portion extending an axial distance and / or radial distance from a tip, endpoint, or end face on the component to which the tip, endpoint, or end face belongs. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. 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 wire 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 each other. The cardiac anchor 20 is carried at the distal end of the catheter 10. The medical wire 40 attached to the cardiac anchor 20 extends toward the proximal end to pass through the catheter 10 (see FIG. 1 ). 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, the anchor 22 is rotationally 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 engages 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 this time, the locking assembly 21 can lock the medical wire 40 at the second position. It should be noted that the first position and the second position represent two different positions or different areas 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 medical line needs to pass through the anchor, which causes the sharp end of the anchor to scratch the medical line. 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 point, the cardiac anchor 20 is carried at the distal end of the catheter 10, with the locking assembly 21 circumferentially confined to the distal end of the catheter 10. The anchor 22 extends distally from the locking assembly 21 to be rotatably connected to the locking assembly 21; that is, the anchor 22 and the locking assembly 21 are rotatable relative to each other circumferentially but are axially fixed and inseparable. The medical wire 40 is movably attached to the locking assembly 21 and then further extends proximally through the catheter 10. At this point, the medical wire 40 can be pulled to freely move at the locking assembly 21. The distal end of the driver 30 is coupled to the proximal end of the anchor 22. The driver 30 is used to drive the cardiac anchor 20 within the catheter 10, and the proximal end of the driver 30 extends through the catheter 10. The driver 30 is removably coupled to the anchor 22, so that after the cardiac anchor 20 is anchored in cardiac tissue, the driver 30 can be detached from the cardiac anchor 20 and withdrawn from the cardiac tissue to the body. In some embodiments, the first position represents the position or area of ​​the cardiac anchor 20 within the catheter 10 when the system 100 is in an initial state. Furthermore, to avoid the risk of human tissue surrounding the system 100 being accidentally scratched by the sharp tip of the anchor 22, the anchor 22 is generally positioned at a safety distance relative to the distal opening of the catheter 10 to prevent the sharp tip of the anchor 22 from being exposed outside the catheter 10. The safety distance refers to the axial distance from the sharp tip of the anchor 22 to the distal opening of the catheter 10.

[0050] Then, when the driver 30 is used to spirally advance the anchor 22 to drive the cardiac anchor 20 to 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-completed state, where the anchor member 22 of the cardiac anchor 20 is anchored and positioned within the cardiac tissue. In some embodiments, the second position represents the location or region of the cardiac anchor 20 within the catheter 10 when the system 100 is in the anchoring-completed 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 further includes an actuator 50, which is carried in the catheter 10 and extends proximally through the catheter 10. 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 can be delivered and carried in the catheter 10 for subsequent operations. Specifically, the distal end of the actuator 50 is removably coupled to 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 actuator 50 is used to actuate the locking assembly 21 in a non-helical manner to lock the medical suture 40 and maintain it at the appropriate tension. For example, the actuator 50 can use a non-helical method such as pressure, tension, or thrust to cause the locking assembly 21 to deform or move, thereby locking the medical suture 40 to the locking assembly 21. This ensures that the advancement method is different from that of the anchor 22, thereby avoiding the defect that the anchor 22 is driven to excessively anchor into or rotate out of the tissue when the thread is locked due to the same advancement method, ultimately leading to implant failure. Furthermore, the locking assembly 21 includes a main body 211 and a locking wire member 212 movably connected to the main body 211. The medical suture 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 suture 40. That is, during the process of locking the medical line 40 , the main body 211 remains fixed at the second position, and thus does not affect the stability of the anchoring member 22 after anchoring.

[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) on the handle 60. The driving mechanism on the proximal handle 60 is manipulated to actuate the driver 30, such as to spirally propel the driver 30 distally. The proximal end of the actuator 50 extends through the catheter 10 and is connected to an actuating mechanism (not shown) on the handle 60. The actuating mechanism on the proximal handle 60 is manipulated to actuate the actuator 50, such as to pull, push, or release the actuator 50 axially proximally.

[0053] It is understood that the catheter 10 and the locking assembly 21 can achieve circumferential limitation of the two by setting mutually cooperating guide grooves and guide parts. Specifically, the catheter 10 is a hollow flexible elongated tube with 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. At least a portion of the guide portion 210 is circumferentially confined within 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 cardiac tissue. Specifically, as Figure 5 As shown, the end of the guide portion 210 extending out of the guide slot 11 is formed with an increased width positioning end 2100. 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 as it moves within the catheter 10. At this point, the longitudinal center axis of the anchor 22 can continue to substantially overlap with the longitudinal center axis of the catheter 10, ensuring that the anchor 22 remains centered in the catheter 10 during delivery. 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. The lug 2100 radially abuts against the outside of the sidewall of the catheter 10 and can slide axially along the trajectory of the guide slot 11 along the outside of the guide slot 11, following the guide portion 210. It will be appreciated 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 dislodging 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 as a whole passes through a blood vessel, the present invention ensures smooth movement of the catheter 10 within the blood vessel by providing a catheter body 12 that is longer and smaller in size. Specifically, the sleeve 13 is connected to the catheter body 12 by a fixed connection method such as laser welding or glue bonding to accommodate the cardiac anchor 20 and thereby prevent the cardiac anchor 20 from causing damage to surrounding tissues. 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 end position of the sleeve 13 to form a guide groove 11 extending axially and having a width W2.

[0055] Figure 7 A schematic diagram of the structure of a cardiac anchor according to a first embodiment is shown. The cardiac anchor 20a includes a locking assembly 21a and an anchoring member 22a. The anchoring member 22a is rotatably connected to the distal end of the locking assembly 21a about the longitudinal axis of the locking assembly 21a. Furthermore, the locking assembly 21a includes a main body 211a and a locking wire member 212a rotatably connected to the main body 211a. The medical wire 40 is positioned between the main body 211a and the locking wire member 212a. In some embodiments, the locking assembly 21a further includes a connecting shaft 213a. The locking wire member 212a is rotatably connected to the main body 211a about the connecting shaft 213a. Under axial actuation by the actuator 50, the locking wire member 212a can rotate toward the main body 211a to compress the medical wire 40 positioned between the main body 211a and the locking wire member 212a against the main body 211a.

[0056] Specifically, if Figure 8-10 As shown, the anchor 22a includes a helical coil 221a for engaging cardiac tissue and a connector 222a disposed proximal to the helical coil 221a. The main body 211a defines an axially extending receiving channel 2110a. The connector 222a is at least partially rotatably received within the receiving channel 2110a and cannot axially escape from the receiving channel 2110a. The helical coil 221a includes a helical segment 2211a with a sharp distal end for engaging cardiac tissue and an axial connecting segment 2212a transitioning from the proximal end of the helical segment 2211a. The axial connecting segment 2212a is coaxially disposed with the helical segment 2211a to prevent radial runout of the anchor 22a during anchoring. The connector 222a is generally hollow and tubular, including an axially extending hollow lumen 2220a for at least partially accommodating the axial connecting segment 2212a of the helical coil 221a. Furthermore, a mounting window 2111a is provided at the side end of the accommodating channel 2110a, and the anchor 22a can be seen and installed in the accommodating channel 2110a through the mounting window 2111a. Figure 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 into 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, the two can be fixed by laser welding at the installation window 2111a using an installation tool. Of course, other methods such as soldering, brazing, adhesives, etc. can also be used for fixing. Figure 9-10To ensure that the anchor member 22a rotates circumferentially relative to the locking assembly 21a after installation, while the two remain axially fixed and inseparable, the present invention provides the receiving channel 2110a with at least two sections having different inner diameters, including a proximal channel 2112a for accommodating at least a portion of the connecting member 222a, and a distal channel 2113a for accommodating at least a portion of the axial connecting section 2212a. The proximal channel 2112a and the distal channel 2113a are interconnected to form the receiving channel 2110a. Furthermore, the proximal channel 2112a has a larger diameter than the distal channel 2113a, and its axial length is also greater than the axial length of the distal channel 2113a. At this time, the intermediate 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 intermediate 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 further 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 with a certain length. The releasing rod 32 is roughly in the shape of a slender rod. It 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. After 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, they can be as follows Figure 12 The special-shaped buckles such as the S-shaped 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, if 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 roughly 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 passes through the body 2113, and the installation window 2111a is provided at the side end of the accommodating channel 2110a away from the guide portion 210a. The guide portion 210a is roughly 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 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 Figure 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 the overall radial position of the cardiac anchor 20a is offset due to the squeezing force caused by the absence of the lug 2100a during the rotation of the locking member 212a relative to the main body 211a to squeeze the medical wire 40. In severe cases, it 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 thread lock member 212a, allowing the thread lock member 212a to be rotatably connected to the support end 2112. Specifically, the support end 2112 includes a main portion 2114 connected to the body 2113 and a support portion 2115 extending from the main portion 2114 toward the guide portion 210a. The main portion 2114 extends circumferentially from the proximal end of the body 2113 to form a disc-shaped shape. Two spaced support portions 2115 extend axially from the disc-shaped main portion 2114 toward the guide portion 210a. Two first axial holes 2114a are symmetrically defined in the two support portions 2115 for pivotally connecting to the thread lock member 212a via the connecting shaft 213a.

[0060] Furthermore, the wire locking member 212a is configured as a lever structure, comprising 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. 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 in shape, with the wire pressing end 2121a protruding from one end of the cylindrical surface of the connecting end 2123a to cooperate with the main end 2111 of the main member 211a to compress the medical wire 40. The driving end 2122a protrudes from the other end of the cylindrical surface of the connecting end 2123a to removably engage 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 Figure 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 opened in the approximate center area of ​​the wire pressing end 2121a and axially passes through the wire pressing end 2121a. In other embodiments, such as Figure 17-18 As shown, the main body 211a and the wire locking member 212a each define a second wire passage 2115a and a first wire passage 2121 for the passage of the medical wire 40. The second wire passage 2115a is located near the lug 2100a on the guide portion 210a, between the guide portion 210a and the main body 2113, and axially extends through the guide portion 210a. The medical wire 40 enters through the second wire passage 2115a and horizontally passes through both the second wire passage 2115a and the first wire passage 2121 before being passed horizontally through the cardiac anchor 20a. This allows for rapid routing of the medical wire 40 in the initial state of the system 100. Specifically, the longitudinal center axis of the first wire passage 2121 substantially overlaps with the longitudinal center axis of the second wire passage 2115a, enabling axially horizontal routing of the wire.

[0062] Continue reading Figure 17-18As shown, in order to improve the locking force of the medical wire 40 located between the main body 211a and the locking wire member 212a, the main end 2111 of the main body 211a is provided with a bearing surface 2116a extending in at least two directions, and the wire pressing end 2121a of the locking wire member 212a is provided with a wire pressing surface 2122 that cooperates with the bearing surface 2116a. The medical wire 40 can be pressed against the bearing surface 2116a by the wire 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 end 2111 and the body 2113, and is as shown in FIG. Figure 17 The L-shaped extension shown is matched with the L-shaped pressing surface 2122 and forms a substantially L-shaped locking length, which can also be as shown in FIG. Figure 18 The U-shaped extension shown cooperates with the U-shaped pressing surface 2122 and forms a generally U-shaped locking length, thereby increasing 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 using the locking 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 to releasing the locking state, thereby minimizing the possibility that the locking member 212a rotates in the opposite direction due to heartbeat and escapes from the locking state of the medical wire 40.

[0064] In some embodiments, as Figure 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 Figure 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 provided on the locking member 212a, and may be, for example, an arc-shaped outer surface with a gradually changing curvature radius on the connecting end 2123a; the retaining member 21412 is movably provided 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. Figure 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. Figure 19 As shown in FIG. 2b, at this point, the second position of the self-locking inclined surface 21414 abuts and remains in the second position of the self-locking section 21411, and the elasticity of the elastic member 21413 is partially or completely released. The radius of curvature R1 of the self-locking section 21411 in the first position is greater than the radius of curvature R2 in 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 curved outer contour or outer surface with a gradually decreasing radius of curvature 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 a section of an involute. That is, during thread locking, the radius of curvature of the self-locking section 21411 decreases from large to small, and the retaining member 21412, under the action of the elastic member 21413, moves toward the thread locking member 212a, completing 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 has a tendency 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 extrusion force on the retaining piece 21412, and the extrusion 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 unlocking can be completed only by overcoming the elastic force of the elastic part 21413 and the friction force of the self-locking slope 21414 on the self-locking section 21411. 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 part 212a, but also ensures the long-term locking of the medical wire 40 by the self-locking mechanism 2141a.

[0065] Furthermore, if Figure 13 and 19As shown, retaining member 21412 includes a wedge-shaped block 21415 and a guide post 21416 connected to the proximal end of wedge-shaped block 21415. An elastic member 21413 is sleeved onto guide post 21416 and axially compressed between wedge-shaped block 21415 and main body 2114 of main body 211a. Specifically, a self-locking inclined surface 21414 is disposed on wedge-shaped block 21415 and faces away from guide post 21416. In other words, self-locking inclined surface 21414 gradually rises as it moves from the distal end to the proximal end of wedge-shaped block 21415. Elastic member 21413 may be a spring (not shown) or an arc-shaped spring. An axially extending guide groove 2117 is provided in the main body 2114 at a roughly central area above the 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 surface 2119, and the retaining member 21412 is slidably disposed on the guide surface 2119 and abuts against the self-locking section 21411 of the thread locking member 212a. Since the guide surface 2119 is a smooth horizontal surface, the angle between the self-locking inclined surface 21414 of the retaining member 21412 and the guide surface 2119 is the inclination angle of the wedge block 21415.

[0067] In other embodiments, Figure 20 As shown, the main body 211a and the locking member 212a engage with each other to form a self-locking mechanism 2142a. Specifically, the main body 211a is provided with a plurality of first engaging teeth, and the connecting end 2123a of the locking member 212a is provided with second engaging teeth for engaging with the first engaging teeth. The locking member 212a can remain in a locked state when the second engaging teeth engage with the first engaging teeth, thereby achieving self-locking. This ensures the long-term stability of the cardiac anchor 20a and effectively prevents the medical line 40 from becoming loose.

[0068] To ensure removable engagement of the actuator 50 with the drive end 2122a, as Figure 13 and 21As shown, the driving end 2122a has a coupling portion 21220, to which the distal end of the actuator 50 is removably coupled. 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 operator control. Thus, under operator control, the actuator 50 is axially actuated proximally in a substantially horizontal direction. The driving end 2122a can generate torque to rotate about the connecting shaft 213a under the axial actuation of the actuator 50, thereby avoiding the defects of the prior art caused by the direction of executing the locking line being the same as the direction of anchoring, which leads to excessive anchoring or anchoring failure. Specifically, the driving end 2122a includes two rods 21221 that are spaced apart and protrude side by side from the connecting end 2123a. The coupling portion 21220 can be a winding shaft 21222 with a smooth outer surface. The winding shaft 21222 is connected between the two rods 21221 and is located 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 being separated from the outer surface of the winding shaft 21222 and causing actuation failure, as shown in FIG. Figure 21 As shown in a, the joint 21220 further includes an anti-slip shaft 21223, which is arranged 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 rewinds around the outer surface of the winding shaft 21222. At the same time, in order to reduce the actuating force required to actuate the locking member 212a to a certain extent to achieve the purpose of labor saving, as shown in FIG. Figure 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 understood that, due to the need to achieve extrusion and locking of the medical wire 40, the main body 211a, the locking wire member 212a, and the connecting shaft 213a are designed to be rigidly connected to each other and can be made of materials such as stainless steel, pure titanium, and titanium alloys; however, the medical wire 40 is generally made of a flexible polymer material. Therefore, when the medical wire 40 passes through the first wire passage 2121 of the locking wire member 212a, or 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 come into direct contact with the main body 211a and the locking wire member 212a. This can cause wear and tear on the medical wire 40 when the system 100 enters the heart, when the medical wire 40 is adjusted, and when the heart beats. This can cause irreversible damage to the medical wire 40, resulting in the medical wire 40 failing to meet fatigue performance requirements and being prone to breakage, ultimately leading to surgical 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 channel through which the medical wire 40 passes, so as to reduce the hardness of the surface of the wire channel. Figure 22 As shown, the buffer member 70 can be a coating applied to the surface of the wire passage with a hardness lower than that of the main body 211a and / or the wire locking member 212a. It can also be a hollow coating or flexible member that passes through the wire passage to allow the medical wire 40 to pass through. The coating or flexible member at least covers the surface of the wire passage. The flexible member can be a cloth cover or a flexible wire. For example, the cloth cover can be fixed to the surface of the first wire passage 2121 and / or the surface of the second wire passage 2115a by bonding or sewing with an adhesive (epoxy resin), or the flexible wire can be wrapped around the surface of the wire passage. This application is explained using the cloth cover 70 as an example. The cloth cover 70 is made of a material with a lower hardness than that of the main body 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 cover 70 made of the polymer material, and the friction between the two is also increased, 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 line 40, the outer diameter of the cloth cover 70 is slightly smaller than the inner diameter of the line passage of the cardiac anchor 20a.

[0071] Figure 23-24 FIG2 shows the unlocked state and the locked state of the cardiac anchor 20a. Figure 23As shown, the anchor member 22a is rotatably connected to the main member 211a. The wire pressing end 2121a is vertically positioned on the main member 211a and is located on the same side of the body 2113 as the guide portion 210a and is generally parallel to the guide portion 210a. The engagement portion 21220 of the driving end 2122a is located on the other side of the body 2113 and is generally below the guide portion 210a. The engagement portion 21220 is disposed away from the support end 2112. After the distal end of the actuator 50 is removably engaged with the engagement portion 21220, the actuator 50 can be axially extended in a generally horizontal direction to the actuating mechanism of the proximal handle 60, allowing the operator to axially actuate the actuator 50 to generate torque at the driving end 2122a. In addition, the free end of the medical wire 40 passes horizontally 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 the following position: Figure 24 The locking state shown. Specifically, the actuator 50 is pulled proximally to activate the engaging portion 21220 of the driving end 2122a to rotate proximally to a position adjacent to the supporting end 2112, that is, the distal end of the locking assembly 21a moves along a generally 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 locking wire 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 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 a movable channel 14 for the driving end 2122a to move. The movable channel 14 is arranged opposite to the guide groove 11 of the catheter 10. For example, the side wall is cut from the distal end of the sleeve 13 to the proximal end of the sleeve 13 to form a closed movable channel 14. The closed movable channel 14 is not only used to allow the driving end 2122a to move freely, but also to prevent the driving end 2122a from moving 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 if it is over-anchored 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 over-anchoring. Of course, the active channel 14 is also used for the driving end 2122a to move from its distal end to the distal end when implementing the locking line. Figure 4 Proximal end shown.

[0073] Figure 25-32 A schematic diagram of some embodiments of the present invention is shown in which the system 100 enters the mitral valve through an intravascular catheter to perform artificial chordae tendineae implantation. The system 100 can complete the implantation of artificial chordae tendineae in 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 this path. Specifically, the delivery sheath 80 is a slender flexible catheter, which is inserted into the femoral vein at the patient's groin at the distal end and advanced to the inferior vena cava 81 and then enters the right atrium 82 inside the heart. After the atrial septum 83 inside the heart is punctured using 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, to ensure that system 100 can smoothly navigate the complex human vascular system to reach the target location inside the heart, catheter 10 can cooperate with a delivery sheath 80 disposed over catheter 10 to achieve multi-stage bending control. In some embodiments, delivery sheath 80 has at least two bending control sections, and catheter 10 has at least one bending control section, such as disposed at the proximal end of sleeve 13 or the distal end of catheter body 12, to achieve at least three levels of bending control functionality for 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 of the medical wire 40 (i.e., the free end) 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 the initial state, and the heart anchor 20a is located in the first position in the catheter 10. Next, the medical wire 40 is kept appropriately taut, 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 against the target position of the papillary muscle, as shown in FIG. Figure 25 shown.

[0075] In some embodiments, in order to prevent the anchor 22a from slipping out of the target position during the process of being anchored into the papillary muscle due to the papillary muscle being too smooth, thereby causing the anchor position of the anchor 22a to deviate from the target position, as shown in FIG. Figure 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 distally, and then the positioning needle 90 is pushed out from the distal opening of the catheter 10 and penetrates the papillary muscle, as shown in FIG. Figure 27 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 manipulation handle 60 is actuated by the driver 30 to drive the anchor 22a out of the distal opening of the catheter 10 and to be anchored 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, and 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 manipulated to withdraw the positioning needle 90 from the cloth cover 70, so that the operator can manipulate 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 the 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 Figure 29 As shown, at this time, the main body 211a remains fixed in the second position, and the thread locking member 212a rotates, thereby preventing the main body 211a from being 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. Figure 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, as shown Figure 31 Finally, the whole is withdrawn to leave the cardiac anchor 20a and the medical line 40 in the human body, as shown Figure 32 As shown; then, a cutting device (not shown) is introduced outside the body along the path of the delivery sheath 80 and the medical wire 40 to the proximal end of the cardiac anchor 20a, and a cutting operation is performed on the medical wire 40 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 cut medical wire 40 will be formed between the leaflets of the heart valve and the ventricular tissue to form artificial chordae tendineae, thereby replacing or supplementing the natural chordae tendineae inside the heart to achieve optimal valve function.

[0077] Figures 33-35A schematic diagram of the structure of a cardiac anchor according to a second embodiment is shown. The cardiac anchor 20b includes a locking assembly 21b and an anchoring member 22b. The anchoring member 22b is rotatably connected to the locking assembly 21b about its longitudinal axis. Furthermore, the locking assembly 21b includes a main body 211b and a locking member 212b axially elastically connected to the main body 211b. The medical wire 40 is positioned between the main body 211b and the locking member 212b. An actuator 50 is configured to engage with the locking member 212b to actuate the locking member 212b to axially move toward the main body 211b and thereby lock the medical wire 40. Specifically, the locking assembly 21b also includes an elastic element 213b, which is axially stretched between the main body 211b and the locking member 212b. The medical wire 40 can be threaded through a portion of the helical section of the elastic element 213b. When the actuator 50 is actuated, for example, the locking wire member 212b is released, 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 located between the main body 211b and the locking wire member 212b to the elastic element 213b.

[0078] In some embodiments, as Figure 34As shown, the main body 211b and the thread-locking member 212b each define an axially extending first and second accommodating channels 2110b and 2120b, respectively. At least the proximal end portion of the anchor member 22b is rotatably received within the first and second accommodating channels 2110b and 2120b. The first and second accommodating channels 2110b and 2120b are configured as two sections with different inner diameters, allowing the anchor member 22b to be axially constrained while being rotationally connected within the channels. Specifically, the main body 211b and the thread-locking member 212b are both generally disc-shaped, with the first and second accommodating channels 2110b and 2120b disposed approximately at the center of the main body 211b and the thread-locking member 212b, respectively. Furthermore, the anchor 22b includes a helical coil 221b for engaging with cardiac tissue and a connector 222b disposed proximal to the helical coil 221b. The helical coil 221b includes a helical segment 2211b having a sharp distal end for engaging with cardiac tissue, and an axial connector 2212b transitioning from the proximal end of the helical segment 2211b. The axial connector 2212b is coaxially disposed with the helical segment 2211b to ensure that the anchor 22b does not experience radial runout when anchored. The connector 222b is generally hollow and tubular and includes an axially extending hollow lumen 2220b. The hollow lumen 2220b has two sections with varying radial dimensions, with the radial dimension of the distal lumen being smaller than the radial dimension of the proximal lumen, allowing the axial connector 2212b to be received within the distal lumen of the hollow lumen 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 rotated and inserted into 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 rotated and accommodated in the second accommodating channel 2120b. Figure 35 As shown, the proximal end of the axial connecting section 2212b passes through the first accommodating channel 2110b and is then fixedly connected to the distal end of the hollow inner cavity 2220b of the connecting member 222b, for example, by laser welding or gluing. At this point, after the connecting member 222b passes through the second accommodating channel 2120b, its distal end abuts the proximal side of the main body 211b, with its proximal end exposed outside the proximal end of the locking member 212b. The elastic element 213b is axially sleeved outside the connecting member 222b, with its ends fixedly connected to the main body 211b and the locking member 212b, respectively, by welding or gluing. A gap is defined between the elastic element 213b and the connecting member 222b to facilitate the passage of the medical wire 40 through the gap to complete the lead. Of course, in other embodiments, the cardiac anchor 20b may further 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 side ends of the main body 211b and the thread locking member 212b extend radially to form a symmetrically arranged first guide portion 210b and a second guide portion 210b'. The first guide portion 210b and the second guide portion 210b' are generally square in shape. A first lug 2100b with an increased width is formed at one end of the first guide portion 210b's disc-shaped body away from the main body 211b, and a second lug 2100b' with an increased width is formed at one end of the second guide portion 210b''s disc-shaped body away from the thread locking member 212b. The first lug 2100b is generally perpendicular to the first guide portion 210b, and the second lug 2100b' is generally 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. 2 ). Figure 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 tubular structure with a variable diameter, including a catheter body 12 and a sleeve 13. For details, please refer to the first embodiment and will not be repeated here.

[0080] In some embodiments, a first wire passage 2111b is axially extended through the first guide portion 210b adjacent to the first lug 2100b, and a second wire passage 2121b is axially extended through the second guide portion 210b' adjacent to the second lug 2100b'. The medical wire 40 enters the gap between the main body 211b and the wire locking member 212b through the first wire passage 2111b, passes through a portion of the spiral section of the elastic element 213b, or through several spiral sections of the elastic element 213b intermittently, and then extends through the second wire passage 2121b of the wire locking member 212b, extending from the interior of the catheter 10 to beyond the proximal end of the handle 60. Of course, the wire passage can be provided only in the main body 211b or only in the wire locking member 212b, or both the main body 211b and the wire locking member 212b are provided with a wire passage, with the medical wire 40 being locked by the elastic element 213b.

[0081] like Figure 34 and 38 As shown, in order to ensure that the anchor 22b and the driver 30 are removably connected, 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. Figure 34 and 35As shown, to ensure removable engagement between the locking assembly 21b and the actuator 50, a third release portion 2122b is provided at the proximal end of the thread lock member 212b, and a fourth release portion 500 is provided at the distal end of the actuator 50, which is 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 in 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 threaded connection.

[0082] When the system 100 is in an initial state, such as Figure 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 confined 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 advance spirally, thereby driving the cardiac anchor 20b to self Figure 37 The first position shown is displaced distally to Figure 38 In the second position shown, the anchor 22b can be spirally pushed out from the distal end of the catheter 10 to anchor into the cardiac tissue, and the locking assembly 21b is circumferentially constrained by the catheter 10 and axially displaced to the second position within the catheter 10. In this 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 line 40 is pulled outside the body to adjust the medical line 40 to an appropriate tension to achieve optimal valve function. Figure 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 chordae tendineae 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 of the embodiment of the present invention. It should be noted that, for those skilled in the art, without departing from the principles of the embodiment of the present invention, several improvements and modifications can be made, and these improvements and modifications are also considered to be within the scope of protection of the present invention. The above is an implementation of the embodiment of the present invention. It should be noted that, for those skilled in the art, without departing from the principles of the embodiment of the present invention, several improvements and modifications can be made, 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 anchoring member rotatably connected to a distal end of the locking assembly, the locking assembly being attached with a medical wire; an actuator carried within the catheter, the actuator engaging the anchor and extending proximally through the catheter; and an actuator carried within the conduit, the actuator engaging the locking assembly; An axially extending guide groove is provided on the side wall of the catheter, and the locking assembly has a guide portion, at least part of the guide portion is circumferentially confined in the guide groove and can move axially along the guide groove, and the guide portion extends out of the guide groove to form a positioning end with increased width at one end, and the positioning end abuts against the outside of the guide groove, and the guide portion is axially penetrated by a wire passing channel at a position adjacent to the positioning end, and the medical wire enters the catheter from outside the guide groove to pass through the wire passing channel; 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, and the anchor is spirally pushed out from the distal end of the catheter to anchor into the heart tissue, and the locking assembly is axially displaced to the second position. At the second position, the actuator actuates the locking assembly in a non-spiral advancement manner to lock the medical wire and maintain it under appropriate tension.

2. The system according to claim 1, wherein The catheter has a distal end with an increased outer diameter, and the guide groove is arranged at the distal end of the catheter.

3. The system according to claim 1, wherein: 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.

4. The system according to claim 3, wherein: 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 rotated and accommodated in the accommodating channel.

5. The system according to claim 4, wherein: 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.

6. The system according to claim 3, wherein: 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 includes 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.

7. The system according to claim 6, wherein: The buffer component includes a coating applied on the surface of the wire passage, or a film or a flexible component covering the surface of the wire passage.

8. The system according to claim 6, wherein: The system further includes a positioning needle removably carried in the wire passage or the buffer and extending proximally through the catheter.

9. The system according to claim 3, wherein: 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.

10. The system according to claim 9, wherein: A self-locking mechanism is provided between the main body and the thread locking member.

11. The system according to claim 3, wherein: The locking assembly also includes an elastic element located between the main body and the locking wire member, and the medical wire passes through a partial spiral section of the elastic element; the locking wire member 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.

12. The system according to claim 1, wherein The system further includes a handle disposed at the proximal end of the catheter, and the driver and the actuator extend proximally through the catheter and are then connected to the handle.

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