Minimally Invasive Artificial Chordae Tendineae Adjustment System

Abstract

The present invention provides a minimally invasive artificial chordae tendineae adjustment system, including a wire locking device. The wire locking device includes a sheath for hooking the artificial chordae tendineae, a pushing member disposed within the sheath, and an adjusting member disposed within the sheath and connected to the proximal end of the pushing member. The adjusting member drives the pushing member to move distally along the axial direction of the sheath, and the distal end face of the pushing member pushes the artificial chordae tendineae hooked by the sheath, so as to increase the length of the artificial chordae tendineae accommodated within the sheath. For the minimally invasive artificial chordae tendineae adjustment system provided by the present invention, after the sheath hooks the artificial chordae tendineae, by driving the pushing member to push the artificial chordae tendineae through the adjusting member, the length of the artificial chordae tendineae within the sheath can be increased, thereby shortening the effective length of the artificial chordae tendineae. During the whole process, only one capture is required, the operation is convenient, and no fixed pressure is applied to the artificial chordae tendineae, which is beneficial to reducing or avoiding chordae tendineae injury.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a minimally invasive artificial chordae tendineae adjustment system. Background Art

[0002] The heart is composed of four chambers: the left atrium, the left ventricle, the right atrium, and the right ventricle. There are septa between the left and right atria and between the left and right ventricles, so they do not communicate with each other. There are valves (atrioventricular valves) between the atria and the ventricles. These valves allow blood to flow only from the atria into the ventricles and prevent backflow.

[0003] The mitral valve is a one-way "valve" between the left atrium (abbreviation: LA) and the left ventricle (abbreviation: LV), which can ensure that blood flows from the left atrium to the left ventricle. A normal and healthy mitral valve has multiple chordae tendineae (abbreviation: CT). The leaflets of the mitral valve are divided into the anterior leaflet and the posterior leaflet. When the left ventricle is in a diastolic state, both are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a systolic state, the chordae tendineae are stretched to ensure that the leaflets will not be washed into the atrial side by the blood flow, and the anterior and posterior leaflets close well, thereby ensuring that blood flows from the left ventricle through the aortic valve (abbreviation: AV) to the aorta. If the chordae tendineae or papillary muscles are diseased, such as chordae tendineae rupture, when the left ventricle is in a systolic state, the mitral valve cannot return to the closed state as in the normal state, and the impact of the blood flow will further cause the leaflets to prolapse into the left atrium, resulting in blood reflux.

[0004] As Figure 1 shown, currently, surgical operations or transcatheter interventional methods can be used to implant suture X as an artificial chordae tendineae to treat the lesions caused by chordae tendineae rupture. After implanting the artificial chordae tendineae, the mitral regurgitation disappears. After a period of time, the cardiac function gradually returns to normal, the heart volume gradually shrinks, and the previously enlarged left ventricle due to reflux will gradually return to a ventricular shape close to normal, that is, the left ventricle decreases. However, as the left ventricle decreases, the implanted artificial chordae tendineae will be in a relaxed state. As Figure 2 shown, at this time, the pulling ability of the artificial chordae tendineae on the leaflets is weakened, and the mitral valve will show mild or severe regurgitation again. At this time, it is necessary to shorten the effective length of the relaxed artificial chordae tendineae to eliminate this lesion.

[0005] In the prior art, there is a technique for transcatheter regulation of chordae tendineae. A hook is used to hook the artificial chordae tendineae, and two clips are used to clamp the artificial chordae tendineae on both sides of the hook respectively. By retracting the hook a certain distance, the two clips move closer to each other to achieve the chordae tendineae regulation function. This technique has the following defects: 1. After hooking the artificial chordae tendineae, two clips still need to be extended to clamp the artificial chordae tendineae, which requires secondary capture of the chordae tendineae; 2. The chordae tendineae regulation requires the two clips to fixedly clamp the artificial chordae tendineae, applying a large pressure to the chordae tendineae to prevent the chordae tendineae from slipping out of the clips, which causes greater damage to the chordae tendineae and affects the long-term fatigue performance of the chordae tendineae. Summary of the Invention

[0006] In view of the deficiencies of the prior art, the present invention provides a minimally invasive artificial chordae tendineae adjustment system, which can adjust the chordae tendineae with a single capture, and does not apply a fixed pressure, so as to reduce or avoid damage to the chordae tendineae.

[0007] To solve the above technical problems, the present invention provides a minimally invasive artificial chordae tendineae adjustment system, including a wire locking device. The wire locking device includes a sheath for hooking the artificial chordae tendineae, a pushing member disposed in the sheath, and an adjusting member disposed in the sheath and connected to the proximal end of the pushing member; the adjusting member drives the pushing member to move distally along the axial direction of the sheath, and the distal end face of the pushing member pushes the artificial chordae tendineae hooked by the sheath to increase the length of the artificial chordae tendineae accommodated in the sheath.

[0008] For the minimally invasive artificial chordae tendineae adjustment system provided by the present invention, after the sheath hooks the artificial chordae tendineae, the adjusting member drives the pushing member to push the artificial chordae tendineae, so as to increase the length of the artificial chordae tendineae in the sheath, thereby shortening the effective length of the artificial chordae tendineae. In the whole process, only one capture is required, the operation is convenient, and no fixed pressure is applied to the artificial chordae tendineae, which is beneficial to reducing or avoiding damage to the chordae tendineae. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the implementation. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0010] Figure 1 It is a schematic diagram of the normal state of the artificial chordae tendineae.

[0011] Figure 2 It is a schematic diagram of the relaxed state of the artificial chordae tendineae.

[0012] Figure 3 It is a schematic structural diagram of the minimally invasive artificial chordae tendineae adjustment system provided by the first embodiment of the present invention.

[0013] Figure 4 is Figure 3 The axial sectional view of the minimally invasive artificial chordae tendineae adjustment system in

[0014] Figure 5 is Figure 3 The axial sectional view of the wire locking device in

[0015] Figure 6 is Figure 5 The three-dimensional structural diagram of the first housing of the sheath in

[0016] Figure 7 is Figure 6 a schematic view of the proximal end face of the first housing in

[0017] Figure 8 is a schematic perspective view of the ejector in

[0018] Figure 9 is Figure 8 an axial sectional view of the ejector in

[0019] Figure 10 is Figure 5 a schematic perspective view of the adjusting member in

[0020] Figure 11 is Figure 10 an axial sectional view of the adjusting member in

[0021] Figure 12 is Figure 10 a schematic perspective view of the assembled adjusting member and ejector in

[0022] Figure 13 is Figure 4 a partial sectional view of the controller in the initial state in

[0023] Figure 14 is Figure 3 a schematic perspective view of the joint and wire lock in

[0024] Figure 15 is Figure 3 a partial sectional view of the joint and sheath in

[0025] Figure 16 is Figure 15 a partial sectional view of the adjustable deflectable sheath in

[0026] Figures 17 to 22 is Figure 3 a schematic view of the usage process of the minimally invasive artificial chordae tendineae adjustment system in

[0027] Figure 23 is a schematic view of the structure of the handle assembly of the minimally invasive artificial chordae tendineae adjustment system provided by the second embodiment of the present invention.

[0028] Figure 24 is Figure 23 an axial sectional view of the front handle in

[0029] Figure 25 is Figure 23 an axial sectional view of the rear handle in

[0030] Figure 26 is Figure 25 a schematic view of the structure of the movable connection assembly in

[0031] Figure 27 is Figure 26 a schematic end view of the movable connection component in

[0032] Figure 28 is Figure 26 a three - dimensional exploded schematic view of the movable connection component in Detailed implementation manners

[0033] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0034] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, 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 a limitation to the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0035] In the description of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", etc. should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0036] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the centers of the distal end and the proximal end of the medical device. The above definitions are only for the convenience of expression and cannot be understood as a limitation to the present invention.

[0037] Please refer to Figure 3 and Figure 4, the present invention provides a minimally invasive artificial chordae tendineae adjustment system 1000, including a wire locking device 100, which can be implanted into a patient's heart for hooking and accommodating an artificial chordae tendineae and adjusting the effective length of the artificial chordae tendineae. Specifically, the wire locking device 100 includes a sheath 10 for hooking the artificial chordae tendineae, a pushing member 20 disposed within the sheath 10, and an adjusting member 30 disposed within the sheath 10 and connected to the proximal end of the pushing member 20; the adjusting member 30 drives the pushing member 20 to move distally along the axial direction of the sheath 10, and the distal end face of the pushing member 20 pushes the artificial chordae tendineae hooked by the sheath 10 to increase the length of the artificial chordae tendineae accommodated within the sheath 10, thereby shortening the effective length of the artificial chordae tendineae and improving the overall tension of the artificial chordae tendineae.

[0038] Among them, to ensure implantation safety, the adjusting member 30, the pushing member 20, and the sheath 10 are preferably made of SUS316L stainless steel, or can also be other materials with good biocompatibility and certain rigidity, such as PEEK, etc. The materials of the three parts can be different or the same.

[0039] In the present invention, after the sheath 10 hooks the artificial chordae tendineae, by driving the pushing member 20 to push the artificial chordae tendineae through the adjusting member 30, the length of the artificial chordae tendineae within the sheath 10 can be increased, thereby shortening the effective length of the artificial chordae tendineae. During the entire adjustment process, only one capture is required, which is convenient for operation, and no fixed pressure is applied to the artificial chordae tendineae, which is beneficial to reducing or avoiding chordae tendineae injury.

[0040] Specifically, please refer to Figures 5 to 7 , the sheath 10 is cylindrical, the sheath 10 is hollow and is provided with a first accommodation cavity 11 extending axially. The pushing member 20 and the adjusting member 30 are accommodated within the first accommodation cavity 11 and are located at the proximal end. The first accommodation cavity 11 at least penetrates the proximal end face of the sheath 10 to facilitate the detachable connection between the controller 200 and the adjusting member 30 from the proximal end of the sheath 10 to drive the adjusting member 30 to rotate (see Figure 4). A first slot 12 penetrating through to the first accommodation cavity 11 is formed in the outer wall of the distal end of the sheath 10 for hooking an artificial tendon cord. Preferably, in this embodiment, the first slot 12 includes a flared slot opening and an oval-shaped slot belly, and there is a constriction between the slot opening and the slot belly. The flared slot opening facilitates the sheath 10 to quickly hook the artificial tendon cord. After the hooked artificial tendon cord enters the oval-shaped slot belly, the constriction can prevent the artificial tendon cord from easily detaching from the slot belly. In this embodiment, a pair of guiding grooves 13 extending along the axial direction of the sheath 10 are formed on the inner circumferential surface of the sheath 10, and the pair of guiding grooves 13 are symmetrical about the axis of the sheath 10. A circular protrusion 14 is further convexly provided on the inner circumferential surface of the proximal end of the sheath 10. A first connecting portion 15 is provided at the proximal end of the sheath 10, and the first connecting portion 15 is used for detachably connecting with a joint 330 (see Figure 1 ) in the guiding device 300 to define the circumferential position of the sheath 10 through the joint 330; the first connecting portion 15 has at least two and is arranged at intervals along the circumferential direction of the sheath 10. In this embodiment, the first connecting portion 15 is 4 connecting grooves arranged at intervals along the circumferential direction of the sheath 10, and each connecting groove extends along the axial direction of the sheath 10, that is, the connecting groove is a slot.

[0041] In this embodiment, the sheath 10 includes a first shell and a second shell that is mated with the first shell. The first shell and the second shell are two semi-cylindrical shells with the same structure. After the first shell and the second shell are mated, the cylindrical sheath 10 is formed, and the first accommodation cavity 11 is formed between the first shell and the second shell.

[0042] Please refer to Figure 5 、 Figure 8 and Figure 9, the pushing member 20 is a hollow and generally cylindrical body. The pushing member 20 includes a second accommodating cavity 22 extending along the axial direction. The second accommodating cavity 22 at least penetrates the proximal end surface of the pushing member 20 to allow the adjusting member 30 to access the second accommodating cavity 22 from the proximal end of the pushing member 20. In this embodiment, the second accommodating cavity 22 penetrates through the opposite ends of the pushing member 20, and the pushing member 20 is provided with a second slot 24 at the distal end. The second slot 24 corresponds to the proximal end of the first slot 12. Herein, the second slot 24 corresponding to the proximal end of the first slot 12 means that the contour line of the second slot 24 is the same as the contour line of the proximal end of the first slot 12, preferably an arc shape, so that when the pushing member 20 pushes the artificial tendon cord, the artificial tendon cord is received in the concave second slot 24, which can play a role in limiting. The inner peripheral surface of the second accommodating cavity 22 is provided with internal threads at least in the proximal part (not shown in the figure). In this embodiment, internal threads are provided on the entire inner peripheral surface of the second accommodating cavity 22. On the upper and lower sides of the outer peripheral surface of the pushing member 20, a pair of guide rods 26 extending along the axial direction of the pushing member 20 are provided. The pair of guide rods 26 cooperate with a pair of guide grooves 13 of the sheath 10. Each guide rod 26 and the corresponding guide groove 13 form a linear pair to limit that the pushing member 20 can only move axially relative to the sheath 10 within the sheath 10 and cannot rotate.

[0043] In other embodiments, the guide rods 26 of the pushing member 20 and the guide grooves 13 of the sheath 10 can be correspondingly provided in other numbers such as 1 group, 3 groups, etc. to form at least one linear pair.

[0044] It can be understood that in other embodiments, the guide rods can protrude from the inner peripheral surface of the sheath 10, and corresponding guide grooves are provided on the outer peripheral surface of the pushing member 20, which can also form at least one linear pair to limit that the pushing member 20 can only move axially relative to the sheath 10.

[0045] Please refer to Figure 5 、 Figures 10 to 12, the adjusting member 30 is generally cylindrical, and includes a main body portion 31 at the distal end and a rotating portion 33 at the proximal end. After the adjusting member 30 accesses the second accommodating cavity 22 of the pushing member 20 from the proximal end of the pushing member 20, the main body portion 31 is received in the second accommodating cavity 22, and the rotating portion 33 is located outside the second accommodating cavity 22. An external thread (not shown in the figure) that mates with the internal thread of the second accommodating cavity 22 is provided on the outer peripheral surface of the main body portion 31, and the main body portion 31 of the adjusting member 30 is threadedly connected to the second accommodating cavity 22 of the pushing member 20. A circular groove 35 is convexly provided on the rotating portion 33, and the circular groove 35 cooperates with a circular protrusion 14 on the inner peripheral surface of the sheath 10. The circular groove 35 and the circular protrusion 14 form a rotating pair for restricting the adjusting member 30 from rotating about the axis relative to the sheath 10 and not being able to move axially.

[0046] In other embodiments, the circular groove 35 of the adjusting member 30 and the circular protrusion 14 of the sheath 10 can be correspondingly arranged in 1 group, 3 groups or other numbers spaced along the axial direction to form at least one rotating pair.

[0047] It can be understood that, in other embodiments, the circular groove can be opened on the inner peripheral surface of the proximal end of the sheath 10, and a circular protrusion is correspondingly convexly provided on the outer peripheral surface of the proximal end of the adjusting member 30, which can also form at least one rotating pair to restrict the adjusting member 30 from rotating only about the axis relative to the sheath 10.

[0048] In this embodiment, the pushing member 20 and the adjusting member 30 are a set of components. The adjusting member 30 accesses the second accommodating cavity 22 of the pushing member 20 from the proximal end of the pushing member 20, and the adjusting member 30 is threadedly connected to the proximal end of the pushing member 20. After the adjusting member 30 and the pushing member 20 are assembled, the assembly is placed in the first accommodating cavity 11 of the sheath 10. Specifically, the guiding rod 26 of the pushing member 20 is placed in the guiding groove 13 of the sheath 10, and the circular protrusion 14 of the sheath 10 is snapped into the circular groove 35 of the adjusting member 30. Then, the first housing and the second housing of the sheath 10 are aligned and fixedly connected by any one of laser welding, bonding, mechanical clamping, etc., thereby completing the assembly of the wire locking device 100.

[0049] As described above, in the present invention, under the limitation of the linear pair formed by the guide rod 26 and the guide groove 13, the ejector 20 can only move axially relative to the sheath 10; under the limitation of the rotary pair formed by the annular groove 35 and the annular protrusion 14, the adjuster 30 can only rotate around the axis relative to the sheath 10. Therefore, when the circumferential position of the sheath 10 is defined by the joint 330 and cannot rotate, the adjuster 30 rotates relative to the ejector 20, and the adjuster 30 can push the ejector 20 to move distally along the axis of the sheath 10, that is, convert the rotational motion of the adjuster 30 into the axial motion of the ejector 20, so that the distal end of the ejector 20 pushes against or away from the artificial chordae tendineae, thereby changing the length of the artificial chordae tendineae accommodated in the sheath 10 to adjust the effective length of the artificial chordae tendineae. During the entire adjustment process, since the adjuster 30 and the ejector 20 are threadedly connected, stepless regulation of the entire adjustment process is achieved. Moreover, when the external force drive is removed, the threaded structure will achieve self-locking. When there is no external force to twist the adjuster 30 or the ejector 20, the axial relative position between the adjuster 30 and the ejector 20 will not change, thereby achieving real-time self-locking of the entire adjustment process. In addition, the proximal end of the adjuster 30 is connected to the sheath 10 and can only rotate relative to the sheath 10, while the ejector 20 can only move axially back and forth relative to the sheath 10. After adjusting the length of the artificial chordae tendineae, the artificial chordae tendineae will be U-shaped and located between the sheath 10 and the ejector 20. The tension of the shortened artificial chordae tendineae has an axial reaction force on the ejector 20, which is equivalent to applying an axial pressure to the thread fit and will enhance the self-locking effect of the threaded structure. In addition, during the adjustment process, it can be paused at any time to observe the regurgitation situation, and then further corresponding adjustments can be made. When the adjustment is excessive, the ejector 20 can also be retracted proximally by reversely twisting the adjuster 30 to achieve a retraction operation.

[0050] Further, please refer to Figure 4 , Figure 11 and Figure 13 together. The minimally invasive artificial chordae tendineae adjustment system 1000 further includes a controller 200, and the distal end of the controller 200 is detachably connected to the adjuster 30.

[0051] Specifically, as Figure 11As shown, the rotating part 33 is provided with a recessed groove 32 from its proximal end surface, and the adjusting member 30 is provided with a receiving cavity 34 extending axially from the bottom surface of the recessed groove 32, and the receiving cavity 34 passes through at least a portion of the main body 31. In this embodiment, the receiving cavity 34 passes through to the distal end of the main body 31, and the receiving cavity 34 is correspondingly connected with the recessed groove 32 to form a through passage. Further, the adjusting member 30 is provided with at least two grooves 36 from the inner wall of the recessed groove 32, and each of the grooves 36 extends along the radial direction of the adjusting member 30. In this embodiment, the adjusting member 30 is provided with two grooves 36 symmetrically, and each of the grooves 36 extends along the radial direction of the adjusting member 30 to pass through the outer peripheral surface of the adjusting member 30, and the grooves 36 are connected with the annular groove 35.

[0052] The controller 200 includes an adjusting tube 210 and a locking rod 250 movably installed in the adjusting tube 210. At least two connecting pieces 212 are arranged at the distal end of the adjusting tube 210. A hook 213 is arranged at the distal end of each connecting piece 212. The locking rod 250 moves distally along the axial direction of the adjusting tube 210 until it is inserted into the receiving cavity 34. The locking rod 250 pushes each connecting piece 212 outwardly along the radial direction of the adjusting tube 210 so that the hook 213 expands outward and is clamped into the slot 36 of the adjusting member 30, so that the adjusting member 30 can be driven to rotate by rotating the adjusting tube 210.

[0053] Specifically, Figure 13 As shown, in this embodiment, the distal end of the adjusting tube 210 is fixedly connected to a connector 214, and the distal end of the connector 214 is symmetrically provided with a pair of connecting pieces 212 made of elastic material, the proximal end of each connecting piece 212 is fixedly connected to the connector 214, the distal end of the connecting piece 212 is a free end, and each connecting piece 212 gradually approaches the axis of the adjusting tube 210 from the proximal end to the distal end. In the initial state, the free ends of the pair of connecting pieces 212 fit together. When the distal end of the locking rod 250 passes through the connecting piece 212, the free ends of the pair of connecting pieces 212 are stretched open, and the hooks 213 at the ends of the free ends penetrate into the two slots 36 of the adjusting member 30 to form a rigid connection, and then continue to push the locking rod 250 to the distal end until the distal end of the locking rod 250 is installed in the receiving cavity 34 of the adjusting member 30, completing the assembly of the controller 200 and the wire locker 100, as shown in FIG. Figure 4 shown.

[0054] Among them, the distal end of the locking rod 250 is tapered, so that it is convenient for the pair of connecting pieces 212 to be pushed to the distal end to be stretched and fitted when assembled. The locking rod 250 can be a metal wire or rod such as stainless steel wire, nickel-titanium wire, copper wire, braided steel cable, etc. The connecting piece 212 is formed by shaping a metal sheet, preferably a metal sheet with shape memory function, such as nickel-titanium alloy, cobalt-chromium alloy, etc., which is heat-treated in a shaping mold after laser cutting. The material of the connector 214 is preferably stainless steel, and memory metal materials or polymer materials can also be selected. The regulating tube 210 can be a composite tube composed of multiple layers of materials, such as an outer membrane of pebax, a braided stainless steel mesh in the middle, and an inner membrane formed by hot melting of a PTFE membrane. It can also be a metal tube or a polymer material tube, such as a nickel-titanium tube, a PEEK tube, and other tubes with certain rigidity and flexibility.

[0055] The connector 214 and the regulating tube 210 may be an integral structure or a non-integrated structure. Preferably, in this embodiment, the connector 214 and the regulating tube 210 are integral, which is beneficial to reducing costs, saving assembly time, and improving assembly accuracy.

[0056] For further information, please also refer to Figure 3 , Figure 14 and Figure 15 The minimally invasive artificial chord adjustment system 1000 also includes a guide device 300 for conveying the wire locking device 100, the guide device 300 includes an adjustable bending sheath tube 310 and a joint 330 fixedly connected to the distal end of the adjustable bending sheath tube 310, the distal end of the joint 330 is provided with a second connection portion 335 corresponding to the first connection portion 15 of the sheath 10, the number of the second connection portions 335 is consistent with the number of the first connection portions 15, and the second connection portions 335 are arranged at intervals along the circumference of the joint 330.

[0057] Specifically, in this embodiment, the first connecting portion 15 is arranged at the proximal end of the sheath 10 and four connecting grooves are arranged at intervals along the circumference of the sheath 10, each of the connecting grooves extends along the axial direction of the sheath 10, and the second connecting portion 335 is a connecting rod that cooperates with the connecting groove. The four connecting rods are arranged at the distal end of the joint 330 and are arranged at intervals along the circumference of the joint 330, and each of the connecting rods is correspondingly inserted into one of the connecting grooves, thereby realizing a detachable connection between the joint 330 and the sheath 10, so as to limit the circumferential position of the sheath 10 by the joint 330, so that the adjusting member 30 rotates relative to the sheath 10 and at the same time rotates relative to the ejecting member 20.

[0058] Among them, the joint 330 is a structural part with a connecting rod and having an inner cavity. Its proximal end is connected to the adjustable bending sheath 310, and its distal end is detachably connected to the sheath 10. The material of the joint 330 can be stainless steel, such as SUS304, etc., or a polymer material with a certain strength, such as PEEK, POM, ABS, etc.

[0059] Among them, as Figure 16 shown, the adjustable bending sheath 310 includes a sheath 311 and at least one set of bending adjustment components embedded in the sheath 311. The bending adjustment components include a traction wire 312, a wire threading tube 313, and an anchoring ring 314. Preferably, multiple sets of the bending adjustment components can be provided in the adjustable bending sheath 310 to obtain a multi-angle bending function. It can be understood that the structure of the adjustable bending sheath 310 is similar to that of the adjustable bending sheath in the prior art, and will not be elaborated here.

[0060] Among them, the controller 200 is movably inserted through the guiding device 300, and can extend into the sheath 10 from the inner cavity of the joint 330 and be detachably connected to the adjusting member 30.

[0061] Please refer to Figures 17 to 22 together. The following will describe the usage process of the minimally invasive artificial chordae tendineae adjustment system 1000 provided in this embodiment with reference to the accompanying drawings.

[0062] First, as Figure 17 shown, for the instrument access, the preferred path is through the femoral artery - abdominal aorta - thoracic aorta - aortic valve orifice - left ventricle. The wire locking device 100 at the distal end of the minimally invasive artificial chordae tendineae adjustment system 1000 is sent near the artificial chordae tendineae X through the guiding device 300. Control the sheath 10 to hook the artificial chordae tendineae X so that the artificial chordae tendineae X falls into its first slot 12.

[0063] Then, as Figure 18 shown, by rotating the proximal end of the adjustment tube 210, the connector 214 and the connecting piece 212 can be driven to rotate synchronously, and then the adjusting member 30 connected to the connecting piece 212 can be driven to rotate relative to the sheath 10, and further drive the pushing member 20 to move distally along the axial direction of the sheath 10. The part of the artificial chordae tendineae X hanging in the first slot 12 of the sheath 10 that contacts the distal end of the pushing member 20 is pushed by the pushing member 20 to move distally, and the artificial chordae tendineae X is bent into a U shape, and the length of the artificial chordae tendineae X accommodated in the sheath 10 becomes longer, thereby reducing the effective length of the artificial chordae tendineae X.

[0064] As Figure 19 and Figure 20As shown, observe the regurgitation state of the mitral valve using medical imaging equipment such as ultrasound until the regurgitation disappears or reaches the mildest state. At this time, stop rotating, and rely on the self-locking ability of the thread between the adjusting member 30 and the pushing member 20 to complete wire locking, so that the regulation of the implant on the chordae tendineae realizes self-locking fixation. Withdraw the locking rod 250 so that it disengages from the connecting piece 212 at the distal end of the adjusting tube 210. The connecting piece 212 rebounds, and the hook 213 at the end of the connecting piece 212 disengages from the adjusting member 30. Continuing to withdraw the adjusting tube 210 can completely separate the wire locking device 100 from the controller 200.

[0065] Then, as Figure 21 shown, withdraw the adjustable bending sheath tube 310 of the guiding device 300, driving the joint 330 to retreat. Since the wire locking device 100 is connected to the chordae tendineae X at this time and is subjected to a certain traction force, the joint 330 can be completely separated from the wire locking device 100 to complete the release operation.

[0066] At this time, as Figure 22 shown, the effective length of the artificial chordae tendineae X is reasonably shortened. The wire locking device 100 is connected to the chordae tendineae X and is retained in the left ventricle.

[0067] During the entire adjustment process, the sheath 10 can perform an adjustment operation by capturing the artificial chordae tendineae X once, which is convenient for operation and saves time. Moreover, the sheath 10 and the pushing member 20 do not apply a fixed pressure to the artificial chordae tendineae X and cooperate with the artificial chordae tendineae X in an active manner, which is beneficial to reducing or avoiding chordae tendineae injury. In addition, a threaded adjustment mechanism is adopted, and during the repair process, real-time stepless adjustment can be performed by observing the regurgitation situation in the state of capturing the chordae tendineae once. If the adjustment is excessive, a retraction operation can be performed, or the operation can be terminated and the instrument can be withdrawn, with relatively high safety.

[0068] Please also refer to Figures 23 to 28 As shown, the structure of the minimally invasive artificial chordae tendineae adjustment system provided by the second embodiment of the present invention is similar to the structure of the minimally invasive artificial chordae tendineae adjustment system 1000 of the first embodiment. The difference is that in the second embodiment, in the minimally invasive artificial chordae tendineae adjustment system, the adjustable bending sheath tube 310 of the guiding device 300 is a two-way bending tube, and a handle assembly is added to make the instrument operation more convenient and fast. Specifically, the handle assembly includes a front handle 400, a rear handle 600, and a handle connector 500 connecting the front handle 400 and the rear handle 600. Among them, the front handle 400 is connected to the proximal end of the adjustable bending sheath tube 310 to drive the adjustable bending sheath tube 310 to move; the rear handle 600 is connected to the proximal ends of the locking rod 250 and the adjusting tube 210 to drive the locking rod 250 and the adjusting tube 210 to move.

[0069] Specifically, in this embodiment, in order to increase the adjustability of the position of the wire locking device 100 in the intracardiac space, the adjustable bending sheath tube 310 is made into a two-way bending tube, that is, the bending function can be realized in three-dimensional directions of the control, specifically, an additional set of bending components is added at different positions between its inner and outer membranes. By controlling the movement of the adjustable bending sheath tube 310, the front handle 400 can adjust the position of the wire locking device 100 in the ventricle and the direction of the first slotted opening 12 thereon, so as to realize the hooking function and hook the chordae tendineae into the slot opening.

[0070] As Figure 24 shown, the front handle 400 includes a front handle housing 470, a central fixing member 480 is provided in the front handle housing 470, and the central fixing member 480 is fixedly connected to the proximal end of the adjustable bending sheath tube 310. Therefore, by controlling the front handle 400, the adjustable bending sheath tube 310 can be driven to move. Specifically, in the front handle 400, a first bending knob 410 is arranged at the distal end of the front handle housing 470, a first bending fitting 420 is arranged in the front handle housing 470 and is threadedly connected to the first bending knob 410, a first traction wire connector 430 is fixedly connected to the first bending fitting 420 and is fixedly connected to the traction wire 312; a second bending knob 450 is arranged at the proximal end of the front handle housing 470, a second bending fitting 460 is threadedly connected to the second bending knob 450, a second traction wire connector 440 is fixedly connected to the second bending fitting 460 and is fixedly connected to the traction wire 312a; wherein, the first bending fitting 420 and the second bending fitting 460 are limited by the central fixing member 480 and can only move back and forth and cannot rotate. By rotating the bending knob, the bending fitting is driven to move proximally, the traction wire connector fixedly connected to the bending fitting is driven to move proximally, the traction wire is driven to move proximally, and the distal tube body of the adjustable bending sheath tube 310 is pulled to bend, so as to realize the bending function.

[0071] As Figure 25 shown, the front handle 400 and the rear handle 600 are connected through the handle connector 500. The handle connector includes a locking silica gel 510, a locking knob 520, and a connecting rod 530. The locking silica gel 510 is arranged in the inner cavity of the central fixing member 480 of the front handle 400 for sealing function. The locking knob 520 is threadedly connected to the inner cavity of the central fixing member 480 of the front handle 400, and the connecting rod 530 is fixedly connected to the central fixing member 620 of the rear handle 600. By twisting the locking knob 520, the front and rear handles are fixedly connected.

[0072] As Figure 25As shown, the rear handle 600 includes a rear handle housing 610, a rear handle central fixing member 620 fixedly connected in the rear handle housing 610, a regulating tube controller 630 for fixedly connecting to the proximal end of the regulating tube 210, a knob 640 movably connected in a staggered manner with the regulating tube controller 630, and a locking lever controller 650. The locking lever controller 650 is also fixedly connected to the proximal end of the locking lever 250. Among them, the regulating tube controller 630, the locking lever controller 650, and the knob 640 are coaxially installed from the inside out.

[0073] Specifically, please refer to Figures 26 to 28 simultaneously. On the outer peripheral surface of the regulating tube controller 630, a plurality of axially extending limiting grooves 710 are circumferentially formed. On the inner peripheral surfaces of the locking lever controller 650 and the knob 640, a plurality of axially extending clamping positions 730 are circumferentially protruded. A clamping position groove 750 is formed between every two adjacent clamping positions 730 on the locking lever controller 650. Each of the clamping positions 730 on the locking lever controller 650 is respectively inserted into one of the limiting grooves 710 on the regulating tube controller 630. Each of the clamping positions 730 on the knob 640 respectively passes through one of the clamping position grooves 750 on the locking lever controller 650 and then is inserted into one of the limiting grooves 710 on the regulating tube controller 630. The clamping positions 730 on the locking lever controller 650 and the clamping positions 730 on the knob 640 are spaced and staggered. It can be seen that the cooperation between the knob 640, the locking lever controller 650, and the regulating tube controller 630 is just staggered, which is a staggered connection. It can be seen that the knob 640 is on the outermost side, the locking lever controller 650 is between the knob 640 and the regulating tube controller 630, and the radial fit of the three is a clearance fit. Therefore, the three can move relatively axially, and further, it is a staggered movable connection. By rotating the knob 640, the locking lever controller 650 and the regulating tube controller 630 can be driven to rotate synchronously to drive the distal end wire. By retracting the locking lever controller 650, the regulating tube controller 630 can be driven to move backward to drive the distal end to release.

[0074] As Figure 26As shown, the knob 640 does not restrict the axial movement of the adjustment tube controller 630, but only restricts its radial movement. The locking rod controller 650 can move backward a certain distance (such as: L) relative to the adjustment tube controller 630. This distance is sufficient to drive the distal end of the locking rod 250 away from the connecting piece 212. By twisting the knob 640, the adjustment tube controller 630 can be driven to rotate, and then the adjustment tube 210 drives the adjustment member 30 to rotate, so that the pushing member 20 pushes the tendon cord distally. After the distal end of the pushing member 20 moves past the first slot 12 of the sheath 10, the wire locking function can be achieved. According to the surgical situation, observe the reflux situation and whether further adjustment is needed. If so, continue to move the pushing member 20 distally in the inner cavity of the sheath 10 to achieve different degrees of adjustment. If the adjustment is abandoned and the operation is terminated, the pushing member 20 can also be driven to move proximally in the sheath 10 by reversing the twist of the knob 640 until the pushing member 20 is withdrawn to the proximal end of the sheath 10. At this time, the artificial tendon cord is in a free state in the first slot 12 of the sheath 10. By adjusting the position of the sheath 10, the artificial tendon cord can be separated from the sheath 10. Therefore, the operation can be terminated at any time.

[0075] Further, after the wire locking is completed, the locking rod controller 650 is retracted. When it moves a distance of L, the distal end of the locking rod 250 is separated from the connecting piece 212, and the hook 213 is reset. Continuing to retract the locking rod controller 650 further drives the adjustment tube controller 630 to move backward. At this time, the distal end of the adjustment tube 210 is completely separated from the wire locking device 100.

[0076] Then, the adjustable bending sheath tube 310 and the joint 330 are completely separated from the wire locking device 100 by driving them with the front handle 400, and the operation is completed.

[0077] Among them, it should be noted that since the traction wire needs to bear a large tensile force during bending adjustment, the parts in the handle connected to the traction wire need to use metal materials to improve stability and strength. Other handle parts can be made of polymer materials such as ABS and PC or metal materials such as stainless steel.

[0078] In this embodiment, by controlling the locking rod controller 650 to move proximally along the axial direction by different distances, the distal end of the locking rod 250 can be driven to separate from the connecting piece 212 at the distal end of the adjustment tube 210, so that the hook 213 is reset, and then the adjustment tube 210 is separated from the adjustment member 30. Further moving the locking rod controller 650 proximally can drive the adjustment tube 210 and the locking rod 250 to be completely separated from the wire locking device 100, thus realizing one-step release with simple and quick operation.

[0079] The above is the implementation manner of the embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention.

Claims

1. A minimally invasive artificial chordae tendineae adjustment system, characterized in that Comprising a wire locking device, the wire locking device includes a sheath, a push member, and an adjusting member connected to the proximal end of the push member; The sheath is hollow and is provided with a first accommodating cavity extending axially, and the push member and the adjusting member are accommodated in the first accommodating cavity; the first accommodating cavity penetrates at least the proximal end face of the sheath, and a first slot communicating with the first accommodating cavity is formed in the outer wall of the distal end of the sheath, and the first slot is used for hooking an artificial tendon cord; The push member is hollow and is provided with a second accommodating cavity extending axially, and the second accommodating cavity penetrates at least the proximal end face of the push member, and the adjusting member accesses the second accommodating cavity from the proximal end of the push member; The minimally invasive artificial tendon cord adjusting system further includes a controller and a guiding device, the controller is movably inserted into the guiding device, and the distal end of the controller is detachably connected to the adjusting member, and the guiding device is used for conveying the wire locking device; The controller controls the adjusting member to rotate relative to the push member to push the push member to move distally along the axial direction of the sheath, and the distal end face of the push member pushes the artificial tendon cord hooked by the sheath to increase the length of the artificial tendon cord accommodated in the sheath.

2. The minimally invasive artificial chordae tendineae adjustment system according to claim 1, wherein The adjusting member is threadedly connected to the proximal end of the push member.

3. The minimally invasive artificial chordae tendineae adjustment system according to claim 2, wherein A linear pair is arranged between the sheath and the push member, and the linear pair defines the axial movement of the push member relative to the sheath; a rotational pair is arranged between the sheath and the adjusting member, and the rotational pair defines the rotational movement of the adjusting member relative to the sheath around the axis.

4. The minimally invasive artificial chordae tendineae adjustment system according to claim 3, wherein The linear pair includes at least one set of guide rods and guide grooves extending along the axial direction of the sheath, the guide rods protrude from the outer peripheral surface of the push member, and the guide grooves are formed in the inner peripheral surface of the sheath; alternatively, the guide rods protrude from the inner peripheral surface of the sheath, and the guide grooves are formed in the outer peripheral surface of the push member.

5. The minimally invasive artificial chordae tendineae adjustment system according to claim 3, characterized in that, The rotational pair includes at least one set of annular grooves and annular protrusions arranged at intervals along the axial direction of the sheath, the annular grooves are formed in the outer peripheral surface of the proximal end of the adjusting member, and the annular protrusions protrude from the inner peripheral surface of the proximal end of the sheath; alternatively, the annular grooves are formed in the inner peripheral surface of the proximal end of the sheath, and the annular protrusions protrude from the outer peripheral surface of the proximal end of the adjusting member.

6. The minimally invasive artificial chordae tendineae adjustment system according to claim 1, characterized in that, The sheath includes a first housing and a second housing that mates with the first housing, and the first accommodating cavity is formed between the first housing and the second housing.

7. The minimally invasive artificial chordae tendineae regulation system according to claim 1, wherein A second slot is formed at the distal end of the push member, and the second slot corresponds to the proximal end of the first slot.

8. The minimally invasive artificial chordae tendineae adjustment system according to claim 1, characterized in that, The adjusting member includes a main body portion at the distal end and a rotating portion at the proximal end, the main body portion is accommodated in the second accommodating cavity, and the rotating portion is located outside the second accommodating cavity.

9. The minimally invasive artificial chordae tendineae adjustment system according to claim 8, wherein, A counterbore is formed in the rotating portion from the proximal end face, and a receiving cavity extending axially is formed in the adjusting member from the bottom surface of the counterbore, and the receiving cavity penetrates at least a part of the main body portion.

10. The minimally invasive artificial chordae tendineae adjustment system according to claim 9, wherein, At least two clamping slots are formed in the adjusting member from the inner wall of the counterbore, and each clamping slot extends radially along the adjusting member.

11. The minimally invasive artificial chordae tendineae adjustment system according to any one of claims 1 to 10, characterized in that, The controller includes an adjusting tube, and at least two connecting pieces are provided at the distal end of the adjusting tube. A hook is provided at the distal end of each connecting piece; the connecting pieces are made of an elastic material; the hooks at the distal ends of the connecting pieces expand outwards and are snapped into the clamping grooves of the adjusting member.

12. The minimally invasive artificial chordae tendineae adjustment system according to claim 11, wherein, The controller further includes a locking rod movably inserted into the adjusting tube. The locking rod moves axially towards the distal end of the adjusting tube and is inserted into the receiving cavity. The locking rod radially outwardly pushes each connecting piece along the adjusting tube, so that the hooks expand outwards and are snapped into the clamping grooves of the adjusting member.

13. The minimally invasive artificial chordae tendineae adjustment system according to claim 12, wherein The minimally invasive artificial chordae tendineae adjusting system further includes an adjustable bending sheath tube. A joint is provided at the distal end of the adjustable bending sheath tube. The sheath is provided with a first connecting portion, and the first connecting portion is detachably connected to the joint. The joint defines the circumferential position of the sheath, so that the adjusting member rotates relative to the sheath while rotating relative to the pushing member.

14. The minimally invasive artificial chordae tendineae adjustment system according to claim 13, characterized in that, The first connecting portion is provided at the proximal end of the sheath, and the number of the first connecting portions is at least two. The at least two first connecting portions are circumferentially spaced along the sheath.

15. The minimally invasive artificial chordae tendineae adjustment system according to claim 13, wherein, A second connecting portion is provided at the distal end of the joint corresponding to the first connecting portion. The number of the second connecting portions is the same as that of the first connecting portions. The second connecting portions are circumferentially spaced along the joint.

16. The minimally invasive artificial chordae tendineae adjustment system according to claim 13, wherein, The minimally invasive artificial chordae tendineae adjusting system further includes a handle assembly. The handle assembly includes a front handle, a rear handle, and a handle connector connecting the front handle and the rear handle; the front handle is connected to the proximal end of the adjustable bending sheath tube; the rear handle is connected to the proximal ends of the locking rod and the adjusting tube.

17. The minimally invasive artificial chordae tendineae adjustment system according to claim 16, wherein The rear handle includes an adjusting tube controller, a locking rod controller, and a knob which are coaxially inserted from inside to outside; the adjusting tube controller is fixedly connected to the proximal end of the adjusting tube, the locking rod controller is fixedly connected to the proximal end of the locking rod, and the locking rod controller and the knob are respectively movably connected to the adjusting tube controller.

18. The minimally invasive artificial chordae tendineae adjustment system according to claim 17, wherein, A plurality of axially extending limiting grooves are circumferentially formed on the outer peripheral surface of the adjusting tube controller. A plurality of axially extending clamping positions are circumferentially protruded on the inner peripheral surfaces of the locking rod controller and the knob. A clamping position groove is formed between every two adjacent clamping positions on the locking rod controller.

19. The minimally invasive artificial chordae tendineae adjustment system according to claim 18, wherein, Each of the clamping positions on the locking rod controller is respectively inserted into a limiting groove on the adjusting tube controller. Each of the clamping positions on the knob respectively passes through a clamping position groove on the locking rod controller and then is inserted into a limiting groove on the adjusting tube controller. The clamping positions on the locking rod controller and the clamping positions on the knob are spaced and staggered.

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