Interventional artificial chordae tendineae implantation system

Abstract

The present invention provides an interventional artificial chordae tendineae implantation system, which includes an artificial chordae tendineae and an artificial chordae tendineae implantation device. The artificial chordae tendineae implantation device includes a sheath tube, a clamping assembly, a puncture needle and an anchoring assembly. The clamping assembly includes a proximal chuck and a distal chuck that open and close relative to each other. Among them, the proximal chuck is fixedly connected to the distal end of the sheath tube, and the distal chuck is provided with a channel that axially penetrates and penetrates the side wall of the distal chuck; the puncture needle is movably inserted through the sheath tube and the proximal chuck and can penetrate into the distal chuck through the channel; the anchoring assembly includes an anchor and a first pusher detachably connected to the anchor, and the first pusher is movably inserted through the puncture needle and pushes the anchor out of the distal end of the puncture needle; the artificial chordae tendineae is movably inserted through the first pusher, and its distal end is connected to the anchor. This interventional artificial chordae tendineae implantation system has a simple structure and is easy to operate, which is beneficial to simplifying the surgical process and saving surgical time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an interventional artificial chordae tendineae implantation system. Background Art

[0002] The mitral valve is a one-way valve between the left atrium and the left ventricle, which can ensure that blood flows from the left atrium to the left ventricle. As Figure 1 shown, a normal and healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, while preventing the blood from flowing from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of valve leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are respectively fixed to the papillary muscles of the left ventricle 3 through their respective chordae tendineae 4. Under normal circumstances, when the left ventricle 3 contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely opposed to each other, preventing the blood from flowing from the left ventricle 3 to the left atrium 2. As Figure 2 shown, when a part of the chordae tendineae 4 of the mitral valve 1 is broken, it will cause poor apposition of the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1. As a result, when the left ventricle 3 contracts, the mitral valve 1 cannot be completely closed, resulting in blood reflux from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".

[0003] Currently, surgical implantation of sutures as artificial chordae tendineae can be used to treat chordae tendineae lesions. However, invasive thoracotomy techniques are required, and general anesthesia and moderate hypothermic cardiopulmonary bypass are used as auxiliary supports. The surgical process is complex, costly, and the patient suffers from a high degree of trauma, a high risk of complications, and a painful recovery process.

[0004] Another treatment method is to implant sutures as artificial chordae tendineae through a minimally invasive method. For example, through a transapical approach, a suture is implanted on the surface of the mitral valve leaflet on the left atrial side to maintain the tension of the ventricular wall on the valve leaflet. An existing transapical artificial chordae tendineae implantation device has a distal end including a proximal clamp head and a distal clamp head that can be relatively opened and closed to clamp the valve leaflet. A sleeve is preset in the distal clamp head, the sleeve is fixedly connected to the suture, and a puncture needle is provided in the proximal clamp head. As Figure 3 shown, the puncture needle 5 passes through the valve leaflet 6 and then penetrates into the inside of the sleeve 7 and is connected to the locking structure inside the sleeve 7. By withdrawing the puncture needle 5, the sleeve 7 and the suture 8 connected to the sleeve 7 are driven to pass through the valve leaflet 6 to achieve artificial chordae tendineae implantation. However, this existing artificial chordae tendineae implantation system requires, on the one hand, a sleeve to be provided in the distal clamp head, and the puncture needle needs to be connected to the sleeve after puncturing the valve leaflet to achieve the connection between the puncture needle and the suture, and the structure is relatively complex; on the other hand, an additional fixing system needs to be replaced to fix the suture to the apex, ventricular wall or papillary muscle, and the surgical process is relatively complex and time-consuming. Summary of the Invention

[0005] To solve the above technical problems, the present invention provides an interventional artificial chordae tendineae implantation system, which has a simple structure and is easy to operate, facilitating the simplification of the surgical process and saving surgical time.

[0006] The artificial chordae tendineae implantation system provided by the present invention includes an artificial chordae tendineae and an artificial chordae tendineae implantation device. The artificial chordae tendineae implantation device includes a sheath tube, a clamping assembly, a puncture needle, and an anchoring assembly. The clamping assembly includes a proximal clamp head and a distal clamp head that open and close relative to each other. Among them, the proximal clamp head is fixedly connected to the distal end of the sheath tube, and the distal clamp head is provided with a channel that penetrates axially and passes through the side wall of the distal clamp head. The puncture needle is movably inserted through the sheath tube and the proximal clamp head and can penetrate into the distal clamp head through the channel. The anchoring assembly includes an anchor and a first pusher that is detachably connected to the anchor. The first pusher is movably inserted through the puncture needle and pushes the anchor out of the distal end of the puncture needle. The artificial chordae tendineae is movably inserted through the first pusher, and its distal end is connected to the anchor.

[0007] In the interventional artificial chordae tendineae implantation system provided by the present invention, the anchoring assembly is movably inserted through the puncture needle, and a channel that penetrates axially and passes through the side wall of the distal clamp head is provided on the distal clamp head for the puncture needle to movably penetrate into. The clamping assembly is used to clamp the valve leaflet, the puncture needle and the anchoring assembly therein are used to puncture the valve leaflet, and then the anchor is pushed out of the puncture needle and the distal clamp head by the first pusher until the anchor is anchored into the ventricular wall or papillary muscle, so that the artificial chordae tendineae connected to the puncture needle is anchored to the ventricular wall or papillary muscle by means of the anchor. Compared with the prior art, the sleeve is omitted in the distal clamp head, and the puncture needle only needs to puncture the valve leaflet, without the operation of the puncture needle and the sleeve cooperating to form a connection, which simplifies the instrument structure and the operation process; in addition, the same set of instruments can be used to complete the valve leaflet puncture and anchor fixation, reducing the operation steps, facilitating the simplification of the surgical process and saving surgical time. Description of the Drawings

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the implementation will be briefly introduced below. Obviously, the drawings in the following description 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.

[0009] Figure 1 It is a schematic diagram of the mitral valve in a normal state.

[0010] Figure 2 It is a schematic diagram of the mitral valve in a state of insufficiency.

[0011] Figure 3 It is a schematic diagram of the puncture process of an artificial chordae tendineae implantation instrument in the prior art.

[0012] Figure 4 It is a partial three-dimensional structure schematic diagram of the interventional artificial chordae implantation system provided by the first embodiment of the present invention.

[0013] Figure 5 It is Figure 4 The three-dimensional structure schematic diagram of the interventional artificial chordae implantation system shown when the clamping assembly is opened.

[0014] Figure 6 It is Figure 4 The partial axial sectional view of the interventional artificial chordae implantation system shown.

[0015] Figure 7 It is Figure 6 The enlarged schematic diagram of part VII shown.

[0016] Figure 8 It is Figure 4 The three-dimensional structure schematic diagram of the distal chuck connecting the drive rod shown.

[0017] Figure 9 It is Figure 8 The end face schematic diagram of the distal chuck connecting the drive rod shown.

[0018] Figure 10 It is Figure 6 The three-dimensional structure schematic diagram of the artificial chordae and the anchoring assembly in

[0019] Figure 11 It is Figure 10 The three-dimensional exploded structure schematic diagram of the artificial chordae and the anchoring assembly shown.

[0020] Figures 12 to 23 It is the schematic diagram of the using process of the interventional artificial chordae implantation system;

[0021] Among them, Figure 12 It schematically shows that the clamping assembly clamps the leaflet;

[0022] Figure 13 It is Figure 12 The enlarged schematic diagram of part XIII in

[0023] Figure 14 It schematically shows that the puncture needle and the anchoring assembly in it puncture the leaflet;

[0024] Figure 15 It is Figure 14 The sectional schematic diagram of

[0025] Figure 16 It schematically shows that the anchoring assembly passes through the puncture needle and the distal chuck;

[0026] Figure 17 It is Figure 16 The sectional schematic diagram of

[0027] Figure 18 shows the separation of the first pusher in the anchoring assembly from the anchor

[0028] Figure 19 is Figure 18 a cross-sectional schematic view

[0029] Figure 20 shows the anchor being anchored into the papillary muscle

[0030] Figure 21 shows that, except for the anchor and the artificial chordae tendineae, the interventional artificial chordae tendineae implantation system is withdrawn from the body

[0031] Figure 22 shows the spacer being pushed to the valve leaflet

[0032] Figure 23 shows the locking device locking and fixing the artificial chordae tendineae to the side of the spacer away from the valve leaflet

[0033] Figure 24 is an axial cross-sectional view of the distal part of the anchoring assembly and the puncture needle of the interventional artificial chordae tendineae implantation system provided by the second embodiment of the present invention

[0034] Figure 25 is Figure 24 a three-dimensional structural schematic view when the anchor of connects the artificial chordae tendineae and the anchor piece of the anchor is in the closed state

[0035] Figure 26 is Figure 25 a three-dimensional structural schematic view when the anchor shown in connects the artificial chordae tendineae and the anchor piece of the anchor is in the unfolded state Detailed implementation manners

[0036] 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 of 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.

[0037] In addition, the descriptions of the following embodiments refer to the attached drawings for illustrating specific embodiments in which the present invention can be implemented. The directional terms mentioned in the present invention, for example, "up", "down", "front", "back", "left", "right", "inside", "outside", "side", etc., are only references to the directions in the attached drawings. Therefore, the directional terms used are for better and clearer illustration and understanding of the present invention, rather than indicating or implying that the system or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be understood as a limitation to the present invention.

[0038] It should be noted that, in order to more clearly describe the structures of the interventional suture implant system and the interventional chordae tendineae implant system, the defined terms "proximal end" and "distal end" described in the specification of the present invention are common terms in the field of interventional medicine. Specifically, the "distal end" refers to the end far from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation. The direction of the rotation central axis of an object such as a cylinder or a tube is defined as the axial direction. The circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius at the same time). The radial direction is the linear direction along the diameter or radius. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The common terms used in the specification of the present invention are only for the purpose of describing specific embodiments and should not be construed as a limitation to the present invention.

[0039] Please refer to Figures 4 to 7 as well. The interventional artificial chordae tendineae implant system 9 provided by the first embodiment of the present invention includes an artificial chordae tendineae 10 and an artificial chordae tendineae implant device 20. Among them, the artificial chordae tendineae implant device 20 includes a sheath tube 21, a clamping assembly 23, a puncture needle 25, and an anchoring assembly 27.

[0040] Specifically, as Figure 4 and Figure 5 shown, the clamping assembly 23 includes a proximal chuck 232 and a distal chuck 234 that can be opened and closed relatively. The proximal chuck 232 is fixedly connected to the distal end of the sheath tube 21; as Figure 6 and Figure 7 shown, the puncture needle 25 is movably inserted through the sheath tube 21 and the proximal chuck 232. A channel 238 that penetrates axially and passes through the side wall of the distal chuck 234 is provided on the distal chuck 234 for the puncture needle 25 to movably penetrate into; as Figure 6 and Figure 7 shown, the anchoring assembly 27 is movably inserted through the puncture needle 25 and includes an anchor nail 271 and a first pusher 273 that is detachably connected to the anchor nail 271. The first pusher 273 is used to push the anchor nail 271 out of the distal end of the puncture needle 25; as Figure 6 and Figure 7 shown, the artificial chordae tendineae 10 is movably inserted through the first pusher 273, and its distal end is connected to the anchor nail 271.

[0041] Furthermore, as Figure 5 and Figure 6As shown, the clamping assembly 23 further includes at least one driving rod 236. The driving rod 236 axially movably passes through the sheath 21 and the proximal chuck 232, and the distal end of the driving rod 236 is fixedly connected to the distal chuck 234. The driving rod 236 moves axially to drive the distal chuck 234 to open and close relative to the proximal chuck 232, thereby clamping the valve leaflet. It should be noted that the artificial chordae tendineae implantation device 20 further includes a handle (not shown in the figure). The proximal ends of the sheath 21, the driving rod 236, the puncture needle 25, and the first pusher 273 all extend outside the human body and are connected to the handle. The handle is used to control the sheath 21, the driving rod 236, the puncture needle 25, the first pusher 273, etc. The specific structure of the handle will not be elaborated here.

[0042] The artificial chordae tendineae 10 as an implant is flexible, that is, the artificial chordae tendineae 10 can be bent arbitrarily without being stretched axially. To ensure the implantation safety, the artificial chordae tendineae 10 can be made of a polymer material with good biocompatibility, preferably polymer materials such as PTFE, e-PTFE, PET, etc. In this embodiment, the artificial chordae tendineae 10 is made of e-PTFE suture.

[0043] Please refer to Figure 6 and Figure 7 , both the proximal chuck 232 and the distal chuck 234 are generally cylindrical. Both the proximal chuck 232 and the distal chuck 234 can be made of a polymer material or a metal material with good biocompatibility. Among them, the polymer material includes but is not limited to one or several of PP, PE, PET, PTFE, Pebax, PC, and the metal material includes but is not limited to stainless steel, nitinol, etc. The materials of the proximal chuck 232 and the distal chuck 234 can be the same or different.

[0044] As Figure 6 and Figure 7 shown, the proximal chuck 232 can be fixedly connected to the distal end of the sheath 21 by any one of threaded connection, snap connection, bonding, or welding. The proximal chuck 232 is provided with a hollow inner cavity that axially penetrates through both ends thereof, and the hollow inner cavity is communicated with the inner cavity of the sheath 21. In addition, the proximal chuck 232 is further provided with a driving rod cavity, which is located on one side of the hollow inner cavity and axially penetrates through both ends of the proximal chuck 232. The driving rod cavity is used for movably passing through the driving rod 236, and the shape of the driving rod cavity matches the shape of the driving rod 236.

[0045] Please refer to Figures 6 to 9 , the distal chuck 234 is fixedly connected to the distal end of the driving rod 236, and the driving rod 236 is used to drive the distal chuck 234 to open and close relative to the proximal chuck 232 to clamp the valve leaflet.

[0046] When the proximal chuck 232 and the distal chuck 234 clamp the leaflet, the distal end face of the proximal chuck 232 and the proximal end face of the distal chuck 234 are the two clamping faces. Optionally, to more effectively clamp the leaflet, at least one of the two clamping faces is provided with an anti-slip structure, and the anti-slip structure can be a concave-convex structure, a corrugated structure, etc., preferably a corrugated structure. Further preferably, in this embodiment, the two clamping faces (i.e., the distal end face of the proximal chuck 232 and the proximal end face of the distal chuck 234) are both inclined with respect to the axial direction of the clamping assembly 23 to facilitate the entry of the leaflet and increase the area of the clamping face.

[0047] As Figures 6 to 9 shown, the channel 238 includes a first groove body 2381 that surrounds the axis of the distal chuck 234 and axially penetrates, and a second groove body 2382 that communicates with the first groove body 2381 and penetrates the side wall of the distal chuck 234. Specifically, as Figure 9 shown, the cross-sectional shape of the first groove body 2381 perpendicular to the axial direction of the distal chuck 234 is arc-shaped, the central angle corresponding to the arc is greater than or equal to 180 degrees, and the diameter of the first groove body 2381 is greater than or equal to the diameter of the puncture needle 25, so that after the puncture needle 25 punctures the leaflet, it can enter the channel 238 unobstructed. In this embodiment, the central angle corresponding to the arc-shaped cross-section of the first groove body 2381 is equal to 180 degrees. As Figure 9 shown, the cross-sectional shape of the second groove body 2382 perpendicular to the axial direction of the distal chuck 234 is generally rectangular, and the width of the rectangle is equal to or less than the diameter of the puncture needle 25 and greater than the diameter of the artificial chord 10, so that the artificial chord 10 can pass through the leaflet and can freely escape from the distal chuck 234 after being anchored to the ventricular wall or papillary muscle by the anchor 271, so that the artificial chord 10 passing through the leaflet is not restricted by the distal chuck 234, so that the distal chuck 234 can be smoothly withdrawn out of the body along with the entire instrument. In this embodiment, the width of the rectangular cross-section of the second groove body 2382 is equal to the diameter of the puncture needle 25.

[0048] Please refer to Figure 6 and Figure 7 , the distal end of at least one drive rod 236 passes through the inner cavity of the sheath 21 and the drive rod cavity of the proximal chuck 232 and exits the distal end of the proximal chuck 232, and then is connected to the distal chuck 234 to drive the distal chuck 234 to open and close relative to the proximal chuck 232. Among them, the drive rod 236 is preferably made of a nickel-titanium tube or nickel-titanium wire, and its cross-sectional shape can be any shape such as circular, rectangular or triangular. It can be understood that the drive rod 236 with a rectangular or triangular cross-section will not rotate when moving axially in the inner cavity of the sheath 21 and the drive rod cavity of the proximal chuck 232, so as to avoid the distal chuck 234 rotating relative to the proximal chuck 232 during the process of the drive rod 236 driving the distal chuck 234 to open and close relative to the proximal chuck 232.

[0049] In other embodiments, a guide rod may be provided between the proximal chuck 232 and the distal chuck 234. The guide rod is parallel to the drive rod 236. One end of the guide rod is fixedly connected to one of the proximal chuck 232 and the distal chuck 234, and the other end of the guide rod is slidably connected to the other of the proximal chuck 232 and the distal chuck 234. Thus, when the drive rod 236 drives the distal chuck 234 to open and close relative to the proximal chuck 232, the guide rod can play a guiding role and cooperate with the drive rod 236 to jointly play an anti-rotation role, and can also prevent the distal chuck 234 from rotating relative to the proximal chuck 232.

[0050] Please refer to again Figure 6 and Figure 7 , the puncture needle 25 is a hollow tube body, having a certain rigidity and flexibility, and is preferably made of nitinol material. The inner cavity of the puncture needle 25 is used for movably threading the anchoring assembly 27, and the distal end of the puncture needle 25 is a sharp end to facilitate puncturing the valve leaflet clamped by the proximal chuck 232 and the distal chuck 234.

[0051] After the puncture needle 25 penetrates the valve leaflet and enters the channel 238 of the distal chuck 234, the anchoring assembly 27 can pass through the valve leaflet together with the puncture needle 25. Then, the first pusher 273 can push the anchor 271 out of the puncture needle 25 and the distal chuck 234 until the anchor 271 is anchored into the ventricular wall or the papillary muscle, so that the artificial chordae tendineae 10 connected to the anchor 271 are anchored to the ventricular wall or the papillary muscle.

[0052] Specifically, please refer to together Figure 6 , Figure 10 and Figure 11 , in this embodiment, the anchor 271 is a spiral anchor, which includes a nail seat 2713 and a spiral nail body 2715 connected to the distal end of the nail seat 2713. The distal end of the artificial chordae tendineae 10 is fixedly connected to the nail seat 2713, and the spiral nail body 2715 rotates to anchor into the ventricular wall or the papillary muscle, so as to anchor the artificial chordae tendineae 10 to the ventricular wall or the papillary muscle. The nail seat 2713 and the spiral nail body 2715 are made of a metal material with good biocompatibility, such as stainless steel.

[0053] The number of the artificial chordae tendineae 10 is at least one, and is fixedly connected to the nail seat 2713 by any one of bonding, knotting or crimping. As Figure 6 shown, in this embodiment, the number of the artificial chordae tendineae 10 is set to one. The nail seat 2713 is provided with a through hole along the axial direction. The distal end of the artificial chordae tendineae 10 passes through the through hole of the nail seat 2713 and is knotted and fixed, so that the knot cannot pass through the through hole of the nail seat 2713, thus forming a fixed connection with the nail seat 2713. It should be noted that the proximal end of the artificial chordae tendineae 10 passes out of the proximal end of the first pusher 273 and extends outside the human body for subsequent locking and trimming.

[0054] As Figure 10 and Figure 11 shown, the first pushing member 273 is a hollow tube body with certain rigidity and flexibility. The first pushing member 273 can be made of a metal material or a polymer material with good biocompatibility, such as nitinol or Peek. In this embodiment, the first pushing member 273 is used to push the anchor 271 out of the distal end of the puncture needle 25 and to drive the anchor 271 to rotate so that the spiral nail body 2715 rotates and anchors into the ventricular wall or papillary muscle. Specifically, in this embodiment, a first connecting portion 2711 is provided on the proximal end of the nail base 2713, and a second connecting portion 2732 corresponding to the first connecting portion 2711 is provided at the distal end of the first pushing member 273. The first connecting portion 2711 and the second connecting portion 2732 are detachably connected, so that the anchor 271 and the first pushing member 273 are detachably connected. Furthermore, the movement of the first pushing member 273 along the axial direction towards the distal end can push the anchor 271 out of the distal end of the puncture needle 25, and the rotation of the first pushing member 273 can drive the anchor 271 to rotate. More specifically, in this embodiment, the first connecting portion 2711 and the second connecting portion 2732 are respectively provided with concave-convex structures that are complementary in shape and spliced with each other. For example, the concave-convex structure is S-shaped, and the first connecting portion 2711 and the second connecting portion 2732 overlap each other, thereby realizing the detachable connection between the anchor 271 and the first pushing member 273. It should be noted that when the first connecting portion 2711 and the second connecting portion 2732 are connected, their interiors are communicated and are in through connection with the inner cavity of the first pushing member 273 and the through hole of the nail base 2713, so as to facilitate the artificial tendon cord 10 to pass through.

[0055] Furthermore, as Figure 10 and Figure 11 shown, in this embodiment, the anchoring assembly 27 further includes a limiting member 275 for restricting the separation of the first connecting portion 2711 and the second connecting portion 2732. Specifically, the limiting member 275 is a hollow tube body with certain rigidity and flexibility. The limiting member 275 can be made of a metal material or a polymer material with good biocompatibility, such as nitinol or Peek. Among them, the materials of the first pushing member 273 and the limiting member 275 can be the same or different. In this embodiment, both the first pushing member 273 and the limiting member 275 are nitinol tubes.

[0056] As Figure 10As shown, in one embodiment, the limiting member 275 axially movably penetrates through the first pushing member 273. When the limiting member 275 moves axially towards the distal end until its distal end is inserted into the interiors of the first connecting portion 2711 and the second connecting portion 2732, it can limit the detachment of the first connecting portion 2711 and the second connecting portion 2732, enabling the first pushing member 273 to be connected to the anchor 271, so as to realize the movement and rotation of the first pushing member 273 driving the anchor 271; when the limiting member 275 moves axially towards the proximal end until its distal end is withdrawn from the interiors of the first connecting portion 2711 and the second connecting portion 2732, it can release the restriction on the first connecting portion 2711 and the second connecting portion 2732, enabling the first pushing member 273 to be separated from the anchor 271, so as to realize the release of the anchor 271.

[0057] In another embodiment, the limiting member 275 can be movably sleeved outside the first pushing member 273. When the limiting member 275 moves axially towards the distal end until its distal end wraps around the exteriors of the first connecting portion 2711 and the second connecting portion 2732, it can limit the detachment of the first connecting portion 2711 and the second connecting portion 2732, enabling the first pushing member 273 to be connected to the anchor 271, so as to realize the movement and rotation of the first pushing member 273 driving the anchor 271; when the limiting member 275 moves axially towards the proximal end until its distal end exposes the exteriors of the first connecting portion 2711 and the second connecting portion 2732, it can release the restriction on the first connecting portion 2711 and the second connecting portion 2732, enabling the first pushing member 273 to be separated from the anchor 271, so as to realize the release of the anchor 271. It can be understood that, compared with penetrating the limiting member 275 through the first pushing member 273, sleeving the limiting member 275 outside the first pushing member 273 will increase the diameter of the puncture needle 25. Therefore, it is preferred that the limiting member 275 penetrates through the first pushing member 273.

[0058] In this embodiment, the interventional artificial chordae tendineae implantation system 9 further includes a gasket, a second pushing member, and a locking device (not shown). After the artificial chordae tendineae 10 are anchored to the ventricular wall or papillary muscle, the gasket and the second pushing member are sleeved on the artificial chordae tendineae 10, and the distal end of the second pushing member abuts against the gasket to push the gasket to move along the artificial chordae tendineae 10 to fit against the valve leaflet. The locking device is used to position one end of the artificial chordae tendineae 10 away from the anchor 271 on the side of the gasket away from the valve leaflet, thereby completing the locking and fixing of the artificial chordae tendineae 10.

[0059] Wherein, the second pusher is a hollow tube body with certain rigidity and flexibility. The second pusher can be made of a metal material or a polymer material with good biocompatibility, such as nitinol or Peek. The gasket is a sheet-like structure with a certain thickness and size, and its material can be selected from materials such as polyester cloth with good biocompatibility. A through-hole for the artificial chordae tendineae 10 to move through is provided on the gasket. Preferably, the diameter of the through-hole is smaller than the diameter of the puncture needle 25. Thus, after the gasket fits on the valve leaflet, it can cover the puncture opening on the valve leaflet, make up for the damage of the valve leaflet, reduce the risk of blood leakage, and can disperse the acting force of the artificial chordae tendineae 10 on the valve leaflet, which is beneficial to reducing the risk of the artificial chordae tendineae 10 tearing the valve leaflet.

[0060] In addition, it should be noted that the interventional artificial chordae tendineae implantation system 9 further includes a guiding sheath (not shown). The sheath tube 21 axially movably passes through the guiding sheath, and at least one adjustable bending section or pre-shaped section is provided at the distal end of the guiding sheath, which can bend the distal end of the guiding sheath so that the guiding sheath can pass along the guide wire through the complex lumen structure of the human body. The sheath tube 21 and the clamping assembly 23 at its distal end can reach the vicinity of the predetermined treatment site through the inner cavity of the guiding sheath.

[0061] Please refer to Figures 12 to 23 together. Taking the transcatheter mitral chordae tendineae repair as an example, the use process of the interventional artificial chordae tendineae implantation system 9 provided by the present invention is described below. Among them, the interventional path of the operation is: femoral vein - inferior vena cava - right atrium - atrial septum - left atrium - mitral valve.

[0062] The first step: Puncture through the femoral vein, send a guide wire until the right atrium, and then puncture the fossa ovalis position of the atrial septum through instruments such as an atrial septum puncture needle, and send the guide wire from the right atrium to the left atrium to reach near the mitral valve, so as to establish a channel from the outside to the inside of the body.

[0063] The second step: Deliver the guiding sheath along the guide wire to near the mitral valve, remove the guide wire and retain the guiding sheath, and then deliver the distal part of the sheath tube 21 of the artificial chordae tendineae implantation device 20 and the clamping assembly 23 to near the mitral valve through the inner cavity of the guiding sheath.

[0064] The third step: Control the drive rod 236 to move distally to drive the distal chuck 234 to open relative to the proximal chuck 232, adjust the position and bending angle of the distal part of the sheath tube 21 until the valve leaflet 6 enters the gap between the proximal chuck 232 and the distal chuck 234, and then control the drive rod 236 to move proximally to drive the distal chuck 234 to close relative to the proximal chuck 232, so that the valve leaflet 6 is clamped between the proximal chuck 232 and the distal chuck 234 (as Figure 12 and Figure 13 shown).

[0065] Step 4: Push the puncture needle 25 and the anchor assembly 27 simultaneously, so that the distal end of the anchor assembly 27 passes through the leaflet 6 (such as Figure 14 and Figure 15 shown).

[0066] Step 5: Synchronously push the first push member 273 and the stop member 275 in the anchor assembly 27, so that the anchor assembly 27 extends out of the puncture needle 25 and the distal clamp 234 until it reaches the papillary muscle or the ventricular wall (such as Figure 16 and Figure 17 shown).

[0067] Step 6: The first pusher 273 is rotated to drive the anchor 271 to rotate, so that the spiral nail body 2715 is anchored into the papillary muscle or the ventricular wall, and then the artificial tendon 10 is anchored on the papillary muscle or the ventricular wall, and then the limiting member 275 is moved proximally to separate the first pusher 273 from the anchor 271, so as to release the anchor 271 (such as Figure 18 and Figure 19 At this time, the proximal clamp 232 and the distal clamp 234 still clamp the leaflet 6, as shown Figure 20 shown.

[0068] Step 7: Move the puncture needle 25, the first pusher 273 and the limiter 275 proximally until they are separated from the leaflet 6 clamped by the proximal clamp 232 and the distal clamp 234, and then control the drive rod 236 to move distally again to drive the distal clamp 234 to open relative to the proximal clamp 232, and then make the artificial chord 10 escape from the channel 238 of the distal clamp 234, and remove the artificial chord implantation device 20; at this time, the artificial chord 10 passes through the leaflet 6, and the distal end is fixed to the papillary muscle or the ventricular wall by the anchor 271, and the proximal end extends outside the patient's body, as shown in FIG. Figure 21 shown.

[0069] Step 8: Figure 22 As shown, the gasket 30 and the second pushing member 40 are respectively sleeved on the artificial chordae tendineae 10 , and the gasket 30 is pushed into the left atrium along the artificial chordae tendineae 10 by the second pushing member 40 until the gasket 10 contacts the valve leaflet 6 .

[0070] Step 9: Figure 23 As shown, the artificial chord 10 is locked and fixed to the side of the gasket 30 away from the leaflet 6 by the locking device 50, and the redundant artificial chord 10 on the proximal side of the gasket 30 is cut off to complete the implantation of the artificial chord 10. It can be understood that in this step, the artificial chord 10 can also be locked and fixed by tying a knot.

[0071] The intervention artificial chordae tendineae implantation system 9 provided by the present invention movably penetrates an anchoring assembly 27 within a puncture needle 25. A channel 238 that axially penetrates and passes through the side wall of the distal chuck 234 is provided on the distal chuck 234 for the puncture needle 25 to movably penetrate into. The valve leaflets are clamped by a clamping assembly 23, and the valve leaflets are punctured by the puncture needle 25 and the anchoring assembly 27 therein. Subsequently, an anchor nail 271 is pushed out of the puncture needle 25 and the distal chuck 234 by a first pusher 273 until the anchor nail 271 is anchored into the ventricular wall or papillary muscle, so that the artificial chordae tendineae 10 connected to the puncture needle 25 are anchored to the ventricular wall or papillary muscle by means of the anchor nail 271. Compared with the prior art, the setting of a sleeve within the distal chuck is omitted. The puncture needle 25 only needs to puncture the valve leaflets, without the operation of the puncture needle and the sleeve cooperating and forming a connection, which simplifies the instrument structure and the operation process. In addition, the same set of instruments can be used to complete valve leaflet puncture and anchor nail fixation, reducing the operation steps, which is beneficial to simplifying the surgical process and saving surgical time.

[0072] It can be understood that the intervention artificial chordae tendineae implantation system 9 of the present invention can also be applicable to the following scenarios. For example, transcatheter intervention artificial chordae tendineae implantation of the mitral valve is carried out through the path of jugular vein - superior vena cava - right atrium - interatrial septum - left atrium - mitral valve, and transatrial intervention artificial chordae tendineae implantation of the mitral valve is carried out through the path of left atrium - mitral valve. For another example, transcatheter intervention artificial chordae tendineae implantation of the tricuspid valve is carried out through the path of femoral vein - inferior vena cava - right atrium - tricuspid valve, transcatheter intervention artificial chordae tendineae implantation of the tricuspid valve is carried out through the path of jugular vein - superior vena cava - right atrium - tricuspid valve, and transatrial intervention artificial chordae tendineae implantation of the tricuspid valve is carried out through the path of right atrium - tricuspid valve. This is not elaborated here. The transcatheter intervention method causes less damage to the human body than the transatrial method.

[0073] Please refer to Figures 24 to 26 simultaneously. The intervention artificial chordae tendineae implantation system provided by the second embodiment of the present invention is similar in structure to the intervention artificial chordae tendineae implantation system 9 provided by the first embodiment. The difference lies in that: in the second embodiment, the anchor nail 271 is a self-expanding anchor nail. The distal end of the first pusher 273 abuts against the proximal end of the anchor nail 271. The first pusher 273 can directly push the anchor nail 271 out of the distal end of the puncture needle 25, and the anchor nail 271 automatically expands to be anchored into the ventricular wall or papillary muscle. Compared with the first embodiment, in the second embodiment, the first pusher 273 directly abuts against the anchor nail 271, and there is no need to set a connecting portion, so that the limiting member 275 can be omitted, which is beneficial to simplifying the overall structure of the intervention artificial chordae tendineae implantation system and saving costs.

[0074] Specifically, as Figures 24 to 26As shown, in the second embodiment, the anchor screw 271 includes a screw body 2717 and at least one anchor plate 2719 connected to the screw body 2717. Preferably, the number of the anchor plates 2719 is set to be multiple, which is beneficial to increasing the anchoring force of the anchor screw 271. Among them, the screw body 2717 has an annular structure, and a plurality of anchor plates 2719 are arranged at intervals along the circumferential direction of the screw body 2717 at the proximal end of the screw body 2717. The proximal end of each anchor plate 2719 (i.e., the end far from the screw body 2717) is a sharp end. Further preferably, the plurality of anchor plates 2719 are evenly spaced along the circumferential direction of the screw body 2717. During the process of the plurality of anchor plates 2719 being anchored into the ventricular wall or papillary muscle, the acting force of the ventricular wall or papillary muscle on the anchor screw 271 through the plurality of anchor plates 2719 is relatively balanced, which is beneficial to improving the anchoring stability of the anchor screw 271.

[0075] It should be noted that in the second embodiment, at least the anchor plate 2719 of the anchor screw 271 is made of a shape memory material through heat setting treatment, preferably nitinol alloy. The anchor plate 2719 is bent in the free state and can undergo elastic deformation to become straight when the anchor plate 2719 is subjected to an external force. Specifically, please refer to Figure 24 and Figure 25 . Before the anchor screw 271 is pushed out of the distal end of the puncture needle 25 by the first pusher 273, the plurality of anchor plates 2719 are in a relatively closed state under the restriction of the puncture needle 25; please refer to Figure 24 and Figure 26 . After the anchor screw 271 is pushed out of the distal end of the puncture needle 25 by the first pusher 273, the plurality of anchor plates 2719 are in an unfolded state, and the sharp end of each anchor plate 2719 faces the screw body 2717 and bends outward simultaneously to be anchored into the ventricular wall or papillary muscle.

[0076] When using the interventional artificial chordae tendineae implantation system provided in the second embodiment, after the puncture needle 25 and the anchor screw 271 inside it pass through the valve leaf, the puncture needle 25 continues to advance distally until the puncture needle 25 penetrates into the ventricular wall or papillary muscle. By pushing the first pusher 273 distally or retracting the puncture needle 25 proximally, the self-expanding anchor screw 271 extends out of the distal end of the puncture needle 25, and the anchor plates 2719 unfold and are thus anchored into the ventricular wall or papillary muscle.

[0077] Optionally, in other embodiments, the distal end of the nail body 2717 is a sharp end. The anchoring assembly 27 further includes an intermediate member movably disposed within the puncture needle 25, and the anchor nail 271 and the first pusher 273 are movably disposed within the intermediate member. When using the interventional artificial chordae tendineae implantation system provided by this embodiment, after the puncture needle 25 punctures the valve leaflet, the pushing stops. Then, the intermediate member and the first pusher 273 are pushed synchronously until the intermediate member abuts against the ventricular wall or papillary muscle, and then the pushing of the intermediate member stops. Only the first pusher 273 is pushed to push the anchor nail 271 out of the distal end of the intermediate member. The sharp end of the nail body 2717 of the anchor nail 271 pierces into the ventricular wall or papillary muscle, and the anchor piece 2719 unfolds and anchors into the ventricular wall or papillary muscle, thereby anchoring the artificial chordae tendineae 10 to the ventricular wall or papillary muscle.

[0078] Wherein, the intermediate member is a hollow tube body, having a certain rigidity and flexibility. The intermediate member can be made of a metal material or a polymer material with good biocompatibility, such as nitinol or Peek.

[0079] In addition, the difference from the first embodiment is also that: in the second embodiment, the nail body 2717 of the annular structure is provided with a receiving cavity (not labeled). The receiving cavity is fixedly connected to a radially extending pin rod 2712. The artificial chordae tendineae 10 are folded in half, and the folded part of the artificial chordae tendineae 10 bypasses the pin rod 2712, thereby realizing the connection between the artificial chordae tendineae 10 and the anchor nail 271. In the second embodiment, after the folded artificial chordae tendineae 10 are anchored to the papillary muscle or myocardium through the anchor nail 271, it is equivalent to the implantation of two artificial chordae tendineae 10.

[0080] The above are the implementation manners 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 retouches can be made, and these improvements and retouches are also regarded as the protection scope of the present invention.

Claims

1. An interventional artificial chordae tendineae implantation system, characterized in that, It includes an artificial chordae tendineae and an artificial chordae tendineae implantation device; The artificial chordae tendineae implantation device includes a sheath tube, a clamping assembly, a puncture needle, and an anchoring assembly; The clamping assembly includes a proximal chuck and a distal chuck that open and close relative to each other. Among them, the proximal chuck is fixedly connected to the distal end of the sheath tube. The distal chuck is provided with a channel that axially penetrates and passes through the side wall of the distal chuck. The channel includes a first groove that axially penetrates around the axis of the distal chuck and a second groove that communicates with the first groove and passes through the side wall of the distal chuck; The puncture needle is movably inserted through the sheath tube and the proximal chuck and can penetrate into the distal chuck through the channel; The anchoring assembly includes an anchor and a first pusher that is detachably connected to the anchor. The first pusher is movably inserted through the puncture needle and pushes the anchor out of the distal end of the puncture needle; The artificial chordae tendineae is movably inserted through the first pusher, and its distal end is connected to the anchor; 2. The interventional artificial chordae tendineae implantation system according to claim 1, wherein The proximal end of the anchor is provided with a first connecting portion, and the distal end of the first pusher is provided with a second connecting portion corresponding to the first connecting portion. The first connecting portion and the second connecting portion are respectively provided with concave-convex structures with complementary shapes and spliced with each other; 3. The interventional artificial chordae tendineae implantation system according to claim 2, wherein The anchoring assembly further includes a limiting member; The limiting member is axially movably inserted through the first pusher, and the distal end of the limiting member is inserted into or withdrawn from the inside of the first connecting portion and the second connecting portion; Or the limiting member is movably sleeved outside the first pusher, and the distal end of the limiting member wraps around or exposes the outside of the first connecting portion and the second connecting portion; 4. The interventional artificial chordae tendineae implantation system according to any one of claims 1-3, characterized in that, The anchor includes a nail seat and a spiral nail body connected to the distal end of the nail seat. The distal ends of at least one artificial chordae tendineae are fixedly connected to the nail seat; the first pusher abuts against the proximal end of the nail seat and drives the anchor to rotate; 5. The interventional artificial chordae tendineae implantation system according to claim 1, wherein The anchor includes a nail body and at least one self-expanding anchor piece connected to the nail body. The distal end of the first pusher abuts against the proximal end of the nail body; 6. The interventional artificial chordae tendineae implantation system according to claim 1, wherein, The anchor includes a nail body and at least one self-expanding anchor piece connected to the nail body, and the distal end of the nail body is a sharp end. The distal end of the first pusher abuts against the proximal end of the nail body; The anchoring assembly further includes an intermediate member movably inserted through the puncture needle. The anchor and the first pusher are movably inserted through the intermediate member; 7. The interventional artificial chordae tendineae implantation system according to claim 1, characterized in that, The cross-sectional shape of the first groove is arc-shaped, the central angle corresponding to the arc is greater than or equal to 180 degrees, and the diameter of the first groove is greater than or equal to the diameter of the puncture needle; the cross-sectional shape of the second groove is rectangular, and the width of the rectangle is equal to or less than the diameter of the puncture needle and greater than the diameter of the artificial chordae tendineae; 8. The interventional artificial chordae tendineae implantation system according to claim 1, wherein It further includes a gasket sleeved on the artificial chordae tendineae and a second pusher. The distal end of the second pusher abuts against the gasket. The second pusher is used to push the gasket to move along the artificial chordae tendineae; the gasket is provided with a through hole for the artificial chordae tendineae to movably pass through, and the diameter of the through hole is smaller than the diameter of the puncture needle; 9. The interventional artificial chordae tendineae implantation system according to claim 8, characterized in that, It further includes a locking device, and the locking device is used to position the end of the artificial chordae tendineae away from the anchor to the gasket.

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