CN114681152A - Interventional artificial chordae implantation system - Google Patents

Abstract

The invention provides an interventional artificial chordae tendineae implantation system, which comprises an artificial chordae tendineae and an artificial chordae tendineae implantation device. The artificial chordae tendineae implanting device comprises a sheath tube, a clamping assembly, a puncture needle and an anchoring assembly. The clamping assembly comprises a near-end clamping head and a far-end clamping head which are oppositely opened and closed, wherein the near-end clamping head is fixedly connected to the far end of the sheath tube, and a channel which is axially communicated and penetrates through the side wall of the far-end clamping head is arranged on the far-end clamping head; the puncture needle is movably arranged in the sheath tube and the near-end chuck and can penetrate into the far-end chuck through the channel; the anchoring component comprises an anchor and a first pushing component detachably connected with the anchor, and the first pushing component movably penetrates through the puncture needle and pushes the anchor out of the far end of the puncture needle; the artificial chordae tendineae are movably arranged in the first pushing component in a penetrating way, and the far end of the artificial chordae tendineae is connected with the anchor. The interventional artificial chordae tendineae implanting system is simple in structure and easy and convenient to operate, and is beneficial to simplifying the operation process and saving the operation time.

Description

Interventional artificial chordae tendineae implantation system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an interventional artificial chordae tendineae implantation system.

Background

The mitral valve is a one-way valve between the left atrium and the left ventricle and ensures blood flow from the left atrium to the left ventricle. As shown in fig. 1, a normal, healthy mitral valve 1 can control blood flow from the left atrium 2 to the left ventricle 3 while avoiding blood flow from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a posterior leaflet 1 b. The anterior leaflet 1a and the posterior leaflet 1b are each fixed to papillary muscles of the left ventricle 3 by a respective chordae tendineae 4. Normally, when the left ventricle 3 contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely apposed, preventing blood from flowing from the left ventricle 3 to the left atrium 2. As shown in fig. 2, when the chordae tendineae 4 of the mitral valve 1 are partially broken, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are caused to coapt poorly, whereby when the left ventricle 3 contracts, the mitral valve 1 cannot close completely, causing blood to flow back from the left ventricle 3 to the left atrium 2, causing a series of pathophysiological changes, called "mitral regurgitation".

At present, the mode that the surgical operation is implanted with suture lines as artificial chordae tendineae is adopted to treat the pathological changes of the chordae tendineae, but an invasive chest opening technology is adopted, general anesthesia and moderate low-temperature extracorporeal circulation are carried out as auxiliary support, the operation process is complex and high in cost, and the patient has high trauma degree, high complication risk and painful recovery process.

Another treatment is to implant sutures as artificial chordae tendineae in a minimally invasive manner. For example, a suture is implanted on the surface of the left atrial side mitral valve leaflets via a transapical approach as an artificial chordae tendineae to maintain the ventricular wall tension against the leaflets. The existing transapical artificial chordae tendineae implanting device has a far end comprising a near end chuck and a far end chuck which can be relatively opened and closed to clamp valve leaflets, a sleeve is preset in the far end chuck, the sleeve is fixedly connected with sutures, and a puncture needle is arranged in the near end chuck, as shown in fig. 3, the puncture needle 5 penetrates into the sleeve 7 after penetrating through the valve leaflets 6 and is connected with a locking structure in the sleeve 7, and the puncture needle 5 is withdrawn to drive the sleeve 7 and the sutures 8 connected with the sleeve 7 to penetrate through the valve leaflets 6 so as to implant the artificial chordae tendineae. However, in the existing artificial chordae tendineae implantation system, on one hand, a sleeve is arranged in the distal end chuck, and the sleeve is connected after the puncture needle punctures the valve leaflet to realize the connection between the puncture needle and the suture, so the structure is complex; on the other hand, the suture needs to be fixed on the apex of the heart, the ventricular wall or the papillary muscle by replacing an additional fixing system, and the operation process is complicated and time-consuming.

Disclosure of Invention

In order to solve the technical problems, the invention provides an interventional artificial chordae tendineae implantation system which is simple in structure and easy and convenient to operate, and is beneficial to simplifying the operation process and saving the operation time.

The artificial chordae tendineae implantation system provided by the invention comprises an artificial chordae tendineae and an artificial chordae tendineae implantation device. The artificial chordae tendineae implanting device comprises a sheath tube, a clamping assembly, a puncture needle and an anchoring assembly. The clamping assembly comprises a near-end clamping head and a far-end clamping head which are opened and closed relatively, wherein the near-end clamping head is fixedly connected with the far end of the sheath tube, and a channel which penetrates through the side wall of the far-end clamping head along the axial direction is arranged on the far-end clamping head. The puncture needle is movably arranged in the sheath tube and the near-end chuck in a penetrating way and can penetrate into the far-end chuck through the channel. The anchoring component comprises an anchor and a first pushing component detachably connected with the anchor, and the first pushing component movably penetrates through the puncture needle and pushes the anchor out of the far end of the puncture needle. The artificial chordae tendineae movably penetrate through the first pushing piece, and the far end of the artificial chordae tendineae is connected with the anchor.

The invention provides an intervention type artificial chordae tendineae implantation system, wherein an anchoring component is movably arranged in a puncture needle in a penetrating way, a channel which penetrates through the side wall of a far-end chuck along the axial direction is arranged on the far-end chuck for the puncture needle to movably penetrate, a valve leaflet is clamped by a clamping component in the channel, the valve leaflet is punctured by the puncture needle and the anchoring component in the puncture needle, and then an anchor is pushed out of the puncture needle and the far-end chuck by a first pushing component until the anchor is anchored into a ventricular wall or papillary muscle, so that the artificial chordae tendineae connected with the puncture needle are anchored on the ventricular wall or the papillary muscle by the anchor. Compared with the prior art, the sleeve arranged in the far-end chuck is omitted, the puncture needle only needs to puncture the valve leaflets, the operation that the puncture needle is matched with the sleeve to form connection is not needed, and the structure and the operation process of the instrument are simplified; in addition, the same instrument can be used for completing the puncture and the anchoring of the valve leaflets, so that the operation steps are reduced, the operation process is simplified, and the operation time is saved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a schematic view of a mitral valve in a normal state.

Fig. 2 is a schematic view of a mitral valve in an incompetent state.

Figure 3 is a schematic illustration of a prior art puncture procedure of an artificial chordae implantation instrument.

Fig. 4 is a partial perspective view of an interventional artificial chordae implantation system according to a first embodiment of the invention.

Figure 5 is a perspective view of the interventional artificial chordae implantation system of figure 4 with the clamping assembly open.

Figure 6 is a partial axial cross-sectional view of the interventional artificial chordae implantation system of figure 4.

Fig. 7 is an enlarged schematic view of the VII portion shown in fig. 6.

Fig. 8 is a perspective view of the distal cartridge of fig. 4 coupled to a drive rod.

Fig. 9 is an end view of the distal cartridge of fig. 8 attached to a drive rod.

Figure 10 is a perspective view of the artificial chordae and anchor assembly of figure 6.

Figure 11 is a schematic perspective exploded view of the artificial chordae and anchor assembly of figure 10.

Figures 12 to 23 are schematic views of the use of the interventional artificial chordae implantation system;

wherein figure 12 illustrates the clamping assembly clamping the leaflets;

FIG. 13 is an enlarged view of XIII in FIG. 12;

FIG. 14 illustrates the piercing needle and the anchoring assembly therein piercing the leaflet;

FIG. 15 is a cross-sectional schematic view of FIG. 14;

FIG. 16 illustrates the anchor assembly passing out of the needle and distal cartridge;

FIG. 17 is a cross-sectional schematic view of FIG. 16;

FIG. 18 illustrates the first pusher member of the anchor assembly separated from the anchor;

FIG. 19 is a cross-sectional schematic view of FIG. 18;

fig. 20 illustrates anchor anchoring into papillary muscles;

figure 21 illustrates the extraction of the interventional artificial chordae implantation system out of the body, except for the anchor and the artificial chordae;

figure 22 illustrates the shim being pushed against the leaflet;

figure 23 illustrates the knotting device securing the artificial chordae locking to the side of the shim away from the leaflets.

Fig. 24 is an axial cross-sectional view of the anchor assembly and the distal portion of the penetrating needle of the interventional artificial chordae implantation system provided in accordance with a second embodiment of the invention.

Fig. 25 is a schematic perspective view of the anchor of fig. 24 with the artificial chordae tendineae attached and the anchor pieces of the anchor in a closed position.

Figure 26 is a schematic perspective view of the anchor of figure 25 with the artificial tendon attached and the anchor blade of the anchor in a deployed condition.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the direction of the appended figures and, therefore, are used in a better and clearer sense to describe and understand the present invention rather than to indicate or imply that the system or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered limiting of the present invention.

It should be noted that, in order to describe the structure of the interventional suture implantation system and the interventional tendon implantation system more clearly, the terms "proximal" and "distal" are used conventionally in the field of interventional medicine. Specifically, "distal" refers to the end of the surgical procedure that is distal from the operator, and "proximal" refers to the end of the surgical procedure that is proximal to the operator. The direction of the central axis of rotation of an object such as a cylinder or a pipe is defined as the axial direction. Circumferential is the direction (perpendicular to the axis and perpendicular to the cross-sectional radius) around the axis of an object such as a cylinder, tube, or the like. Radial is the linear direction along a diameter or radius. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Referring to fig. 4 to 7, the interventional artificial chordae implantation system 9 according to the first embodiment of the present invention includes an artificial chordae 10 and an artificial chordae implantation device 20, wherein the artificial chordae implantation device 20 includes a sheath 21, a clamping assembly 23, a puncture needle 25 and an anchoring assembly 27.

Specifically, as shown in fig. 4 and 5, the clamping assembly 23 includes a proximal clamping head 232 and a distal clamping head 234 which can be opened and closed relatively, the proximal clamping head 232 is fixedly connected to the distal end of the sheath 21; as shown in fig. 6 and 7, the puncture needle 25 is movably inserted into the sheath 21 and the proximal collet 232, and a passage 238 axially penetrating through the distal collet 234 and penetrating through a sidewall of the distal collet 234 is provided on the distal collet 234 for the puncture needle 25 to movably penetrate; as shown in fig. 6 and 7, the anchoring element 27 is movably disposed through the puncture needle 25, and includes an anchor 271 and a first pushing member 273 detachably connected to the anchor 271, wherein the first pushing member 273 is used for pushing the anchor 271 out of the distal end of the puncture needle 25; as shown in fig. 6 and 7, the artificial chorda 10 is movably disposed through the first pusher 273 and has its distal end connected to the anchor 271.

Further, as shown in fig. 5 and 6, the clamping assembly 23 further includes at least one driving rod 236, the driving rod 236 is axially movably disposed in the sheath 21 and the proximal collet 232, a distal end of the driving rod 236 is fixedly connected to the distal collet 234, and the driving rod 236 moves axially to drive the distal collet 234 to open and close relative to the proximal collet 232 to clamp the valve leaflet. It should be noted that the artificial chordae implantation device 20 further includes a handle (not shown), and the proximal ends of the sheath 21, the driving rod 236, the puncture needle 25 and the first pushing member 273 all extend out of the human body and are connected to the handle, and the handle is used for controlling the sheath 21, the driving rod 236, the puncture needle 25, the first pushing member 273, and the like, which is not described in detail herein.

The artificial chordae 10 as an implant is flexible, i.e. the artificial chordae 10 can be bent at will without being stretched in the axial direction; to ensure the implantation safety, the artificial chordae tendineae 10 may be made of a polymer material with good biocompatibility, preferably a polymer material such as PTFE, e-PTFE, PET, etc. In this embodiment, the artificial chordae 10 are e-PTFE sutures.

Referring to both FIGS. 6 and 7, the proximal collet 232 and the distal collet 234 are generally cylindrical. The proximal and distal collets 232 and 234 may each be made of a polymer material with good biocompatibility including, but not limited to, one or more of PP, PE, PET, PTFE, Pebax, PC, or a metal material including, but not limited to, stainless steel, nickel titanium, etc. The material of the proximal collet 232 and the distal collet 234 may be the same or different.

As shown in fig. 6 and 7, the proximal collet 232 may be fixedly attached to the distal end of the sheath 21 by any means such as screwing, snap-fitting, bonding, or welding. The proximal end chuck 232 is provided with a hollow inner cavity which axially penetrates through two ends of the proximal end chuck, and the hollow inner cavity is communicated with the inner cavity of the sheath tube 21; in addition, the proximal end chuck 232 is further provided with a driving rod cavity, the driving rod cavity is located on one side of the hollow inner cavity and axially penetrates through two ends of the proximal end chuck 232, the driving rod cavity is used for movably penetrating the driving rod 236, and the shape of the driving rod cavity is matched with that of the driving rod 236.

Referring to fig. 6-9, the distal collet 234 is fixedly connected to the distal end of the driving rod 236, and the driving rod 236 is used for driving the distal collet 234 to open and close relative to the proximal collet 232 to clamp the valve leaflet.

When the proximal collet 232 and the distal collet 234 clamp the valve leaflet, the distal surface of the proximal collet 232 and the proximal surface of the distal collet 234 are two clamping surfaces. Optionally, to clamp the valve leaflets more effectively, at least one of the two clamping surfaces is provided with an anti-slip structure, which may be a concavo-convex structure, a corrugated structure, or the like, preferably a corrugated structure. Further preferably, in this embodiment, the two clamping surfaces (i.e. the distal surface of the proximal clamping head 232 and the proximal surface of the distal clamping head 234) are arranged obliquely to the axial direction of the clamping assembly 23, so as to facilitate the valve leaflet entering and increase the area of the clamping surfaces.

As shown in fig. 6-9, the channel 238 includes a first slot 2381 that extends axially through and around the axis of the distal collet 234 and a second slot 2382 that communicates with the first slot 2381 and extends through a side wall of the distal collet 234. Specifically, as shown in fig. 9, the cross section of the first groove 2381 perpendicular to the axial direction of the distal collet 234 is arc-shaped, the central angle corresponding to the arc-shaped is greater than or equal to 180 degrees, and the diameter of the first groove 2381 is greater than or equal to the diameter of the puncture needle 25, so that the puncture needle 25 can enter the channel 238 without obstruction after puncturing the valve leaflets. In this embodiment, a central angle corresponding to the arc-shaped cross section of the first groove 2381 is equal to 180 degrees. As shown in fig. 9, the cross-sectional shape of the second slot 2382 perpendicular to the axial direction of the distal collet 234 is generally rectangular, and the width of the rectangle is equal to or smaller than the diameter of the puncture needle 25 and larger than the diameter of the artificial chordae tendineae 10, so that the artificial chordae tendineae 10 passing through the valve leaflet and anchored to the ventricular wall or papillary muscle by the anchor 271 can freely escape from the distal collet 234, so that the artificial chordae tendineae 10 passing through the valve leaflet is not restrained by the distal collet 234, and the distal collet 234 can be smoothly withdrawn out of the body with the entire instrument. In this embodiment, the width of the rectangular cross section of the second groove 2382 is equal to the diameter of the puncture needle 25.

Referring to fig. 6 and 7, the distal end of at least one driving rod 236 passes through the lumen of the sheath 21 and the driving rod lumen of the proximal collet 232 and out of the distal end of the proximal collet 232, and then is connected to the distal collet 234 for driving the distal collet 234 to open and close relative to the proximal collet 232. The driving rod 236 is preferably made of a nickel titanium tube or a nickel titanium wire, and the cross-sectional shape thereof may be any shape such as a circle, a rectangle, or a triangle. It will be appreciated that the drive shaft 236, which may be rectangular or triangular in cross-section, does not rotate when it moves axially within the lumen of the sheath 21 and the drive shaft lumen of the proximal collet 232, thereby preventing rotation of the distal collet 234 relative to the proximal collet 232 during opening and closing of the distal collet 234 relative to the proximal collet 232 by the drive shaft 236.

In other embodiments, a guide rod may be disposed between the proximal collet 232 and the distal collet 234, and the guide rod is parallel to the driving rod 236, wherein one end of the guide rod is fixedly connected to one of the proximal collet 232 and the distal collet 234, and the other end of the guide rod is slidably connected to the other of the proximal collet 232 and the distal collet 234, so that when the driving rod 236 drives the distal collet 234 to open and close relative to the proximal collet 232, the guide rod can function as a guide and cooperate with the driving rod 236 to function as a rotation stop, so as to prevent the distal collet 234 from rotating relative to the proximal collet 232.

Referring again to fig. 6 and 7, the needle 25 is a hollow tube, preferably made of nickel titanium, which has some rigidity and flexibility. The lumen of the needle 25 is adapted to movably pass through the anchor assembly 27, and the distal end of the needle 25 is sharpened to facilitate puncturing of the leaflets held by the proximal and distal collets 232, 234.

After the puncture needle 25 passes through the leaflet and into the channel 238 of the distal collet 234, the anchoring assembly 27 can pass through the leaflet along with the puncture needle 25, and then the first pusher 273 can push the anchor 271 out of the puncture needle 25 and the distal collet 234 until the anchor 271 anchors into the ventricular wall or papillary muscle, thereby anchoring the artificial chordae tendineae 10 connected to the anchor 271 to the ventricular wall or papillary muscle.

Specifically, referring to fig. 6, 10 and 11, in the present embodiment, the anchor 271 is a screw-type anchor, which includes a nail holder 2713 and a screw body 2715 connected to the distal end of the nail holder 2713, the distal end of the artificial chordae tendineae 10 is fixedly connected to the nail holder 2713, and the screw body 2715 rotates to anchor the ventricular wall or papillary muscle, thereby anchoring the artificial chordae tendineae 10 to the ventricular wall or papillary muscle. The nail holder 2713 and the screw nail body 2715 are made of metal materials with good biocompatibility, such as stainless steel.

The number of the artificial chordae tendineae 10 is at least one, and the staple holder 2713 is fixedly connected by any one of bonding, knotting, or crimping. As shown in fig. 6, in this embodiment, the artificial chordae tendineae 10 are provided in one number, the staple holder 2713 is provided with a through hole in the axial direction, and the distal end of the artificial chordae tendineae 10 is passed through the through hole of the staple holder 2713 and fixed by knotting so that the knot cannot pass through the through hole of the staple holder 2713, thereby forming a fixed connection with the staple holder 2713. It should be noted that the proximal end of the artificial chordae 10 extends out of the proximal end of the first pusher 273 and out of the body for subsequent locking and cutting.

As shown in fig. 10 and 11, the first pushing member 273 is a hollow tube with certain rigidity and flexibility, and the first pushing member 273 may be made of a metal material or a polymer material with good biocompatibility, such as nickel titanium or Peek. In this embodiment, the first pusher 273 is used to push the anchor 271 out of the distal end of the piercing needle 25 and to drive the anchor 271 to rotate so that the helical shank 2715 is rotationally anchored into the ventricular wall or papillary muscle. Specifically, in this embodiment, a first connection portion 2711 is disposed on the proximal end of the nail holder 2713, a second connection portion 2732 is disposed at the distal end of the first pushing member 273 corresponding to the first connection portion 2711, the first connection portion 2711 is detachably connected to the second connection portion 2732, so that the anchor 271 is detachably connected to the first pushing member 273, and further the first pushing member 273 moves axially to the distal end to 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 connection portion 2711 and the second connection portion 2732 are respectively provided with complementary concave-convex structures that are spliced with each other, for example, the concave-convex structures are S-shaped, and the first connection portion 2711 and the second connection portion 2732 are overlapped with each other, so as to realize the detachable connection between the anchor 271 and the first pushing member 273. It should be noted that when the first connecting portion 2711 is connected to the second connecting portion 2732, the first connecting portion 2711 is internally communicated with the inner cavity of the first pushing member 273 and the through hole of the nail holder 2713, so as to facilitate the passage of the artificial chordae tendineae 10.

Further, as shown in fig. 10 and 11, in the present embodiment, the anchor assembly 27 further includes a limiting member 275 for limiting the separation of the first connecting portion 2711 and the second connecting portion 2732. Specifically, the limiting member 275 is a hollow tube having certain rigidity and flexibility, and the limiting member 275 may be made of a metal material or a polymer material with good biocompatibility, such as nickel titanium or Peek. The materials of the first pushing member 273 and the limiting member 275 may be the same or different. In this embodiment, the first pushing member 273 and the limiting member 275 are all made of a nickel-titanium tube.

As shown in fig. 10, in an embodiment, the limiting member 275 is axially movably inserted into the first pushing member 273, and the limiting member 275 axially moves to a far end until the far end is inserted into the first connecting portion 2711 and the second connecting portion 2732, so as to limit the separation of the first connecting portion 2711 and the second connecting portion 2732, so that the first pushing member 273 is connected to the anchor 271, and the first pushing member 273 drives the anchor 271 to move and rotate; the limiting member 275 axially moves proximally to withdraw the distal end from the inside of the first connecting portion 2711 and the second connecting portion 2732, so that the limitation of the first connecting portion 2711 and the second connecting portion 2732 can be released, and the first pushing member 273 can be separated from the anchor 271 to release the anchor 271.

In another embodiment, the retaining member 275 can be movably sleeved outside the first pushing member 273, and the retaining member 275 axially moves to a far end to a position where the far end surrounds the outside of the first connecting portion 2711 and the second connecting portion 2732, so as to limit the separation of the first connecting portion 2711 and the second connecting portion 2732, so that the first pushing member 273 is connected to the anchor 271, and the first pushing member 273 drives the anchor 271 to move and rotate; the limiting member 275 moves axially and proximally to expose the outside of the first connecting portion 2711 and the second connecting portion 2732 at the distal end, and can release the limitation of the first connecting portion 2711 and the second connecting portion 2732, so that the first pushing member 273 can be separated from the anchor 271 to release the anchor 271. It can be appreciated that the diameter of the puncture needle 25 is increased by sleeving the retaining member 275 outside the first pushing member 273 compared to inserting the retaining member 275 inside the first pushing member 273, and therefore, it is preferable that the retaining member 275 is inserted inside the first pushing member 273.

In this embodiment, the interventional artificial chordae implantation system 9 further comprises a spacer, a second pusher and a locking device (not shown). After the artificial chordae tendineae 10 are anchored on the ventricular wall or papillary muscle, the pad 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 pad for pushing the pad to move along the artificial chordae tendineae 10 to be attached to the valve leaflet, the locking device is used for positioning one end of the artificial chordae tendineae 10 far from the anchor 271 on one side of the pad far from the valve leaflet, thereby completing the locking fixation of the artificial chordae tendineae 10.

The second pushing member is a hollow tube body, has certain rigidity and flexibility, and can be made of a metal material or a polymer material with good biocompatibility, such as nickel titanium or PEEK; the gasket is of a sheet structure with certain thickness and size, the material of the gasket can be polyester cloth and other materials with good biocompatibility, a through hole for the artificial chordae tendineae 10 to movably penetrate through is formed in the gasket, preferably, the diameter of the through hole is smaller than that of the puncture needle 25, therefore, the gasket can cover a puncture opening in the valve leaflet after being attached to the valve leaflet, damage to the valve leaflet is made up, risk of blood leakage is reduced, acting force of the artificial chordae tendineae 10 on the valve leaflet can be dispersed, and the risk that the valve leaflet is torn by the artificial chordae tendineae 10 is reduced.

In addition, it should be noted that the interventional artificial chordae implantation system 9 further includes an introducer sheath (not shown), the sheath 21 is axially movably disposed in the introducer sheath, and the distal end of the introducer sheath is provided with at least one adjustable bending section or pre-shaping section, which can bend the distal end of the introducer sheath to pass the introducer sheath along the guide wire through the complicated lumen structure of the human body, and the sheath 21 and the clamping assembly 23 at the distal end thereof can pass through the lumen of the introducer sheath to reach the vicinity of the predetermined treatment site.

Referring to fig. 12-23, the following description of the interventional artificial chordae implantation system 9 of the present invention is provided by way of example for transcatheter mitral chordae repair. Wherein, the intervention route of the operation is as follows: transfemoral-inferior vena cava-right atrium-interatrial-left atrium-mitral valve.

The first step is as follows: the guide wire is fed to the right atrium through femoral vein puncture, the fossa ovalis position of the interatrial septum is punctured through instruments such as an interatrial septum puncture needle and the like, the guide wire is fed to the left atrium from the right atrium and reaches the position near the mitral valve, and therefore a channel from the outside to the inside of the body is established.

The second step is that: the guide sheath is delivered over the guide wire to the vicinity of the mitral valve, the guide sheath is removed and retained, and the distal portion of the sheath 21 of the artificial chordae implant device 20 and the clamping assembly 23 are delivered through the lumen of the guide sheath to the vicinity of the mitral valve.

The third step: the drive rod 236 is controlled to move distally to open the distal collet 234 relative to the proximal collet 232, adjust the position and bend angle of the distal portion of the sheath 21 until the leaflet 6 enters the gap between the proximal collet 232 and the distal collet 234, and then the drive rod 236 is controlled to move proximally to close the distal collet 234 relative to the proximal collet 232, so that the leaflet 6 is clamped between the proximal collet 232 and the distal collet 234 (see fig. 12 and 13).

The fourth step: simultaneously advancing the needle 25 and anchor assembly 27 so that the distal end of the anchor assembly 27 passes with the needle 25 through the leaflet 6 held by the proximal and distal collets 232, 234 (as shown in fig. 14 and 15).

The fifth step: the first pusher 273 and retainer 275 of anchor assembly 27 are simultaneously advanced to extend anchor assembly 27 through needle 25 and distal cartridge 234 until it reaches the vicinity of the papillary muscle or ventricular wall (see fig. 16 and 17).

Sixthly, performing secondary treatment; the first pushing member 273 is rotated to rotate the anchor 271, so that the screw body 2715 is anchored into the papillary muscle or the ventricular wall, the artificial chordae tendineae 10 are anchored on the papillary muscle or the ventricular wall, and then the limiting member 275 is moved proximally, so that the first pushing member 273 is separated from the anchor 271, and the anchor 271 is released (as shown in fig. 18 and 19); at this point, the proximal and distal collets 232 and 234 still grip the leaflets 6, as shown in fig. 20.

The seventh step: moving the puncture needle 25, the first pushing member 273 and the retaining member 275 proximally to disengage the valve leaflet 6 held by the proximal collet 232 and the distal collet 234, and then controlling the driving rod 236 to move distally again to open the distal collet 234 relative to the proximal collet 232, so that the artificial chordae tendineae 10 are released from the channel 238 of the distal collet 234, and removing the artificial chordae implantation device 20; at this point, the artificial chordae tendineae 10 are passed through the leaflets 6, with the distal end anchored to the papillary muscles or ventricular wall by anchors 271 and the proximal end extending outside the patient's body, as shown in fig. 21.

Eighth step; as shown in fig. 22, the spacer 30 and the second pushing member 40 are respectively sleeved on the artificial chordae tendineae 10, and the spacer 30 is pushed into the left atrium along the artificial chordae tendineae 10 by the second pushing member 40 until the spacer 10 contacts the valve leaflets 6.

The ninth step: as shown in fig. 23, the artificial chordae 10 are sutured to the spacer 30 on the side away from the leaflets 6 by the knotting device 50, and the excess artificial chordae 10 on the proximal side of the spacer 30 is cut off to complete the implantation of the artificial chordae 10. It will be appreciated that the artificial chordae 10 may also be secured by knotting in this step.

The interventional artificial chordae tendineae implantation system 9 provided by the invention is characterized in that an anchoring component 27 is movably arranged in a puncture needle 25 in a penetrating manner, a channel 238 which penetrates through the side wall of a distal clamping head 234 along the axial direction is arranged on the distal clamping head 234 and is used for the puncture needle 25 to movably penetrate, a valve leaflet is clamped by a clamping component 23, the valve leaflet is punctured by the puncture needle 25 and the anchoring component 27 in the puncture needle 25, and then an anchoring nail 271 is pushed out of the puncture needle 25 and the distal clamping head 234 by a first pushing component 273 until the anchoring nail 271 is anchored in the ventricular wall or papillary muscle, so that an artificial chordae tendineae 10 connected with the puncture needle 25 is anchored 271 in the ventricular wall or the papillary muscle by the anchoring nail. Compared with the prior art, the sleeve arranged in the far-end chuck is omitted, the puncture needle 25 only needs to puncture the valve leaflets, the operation that the puncture needle is matched with the sleeve to form connection is not needed, and the structure and the operation process of the instrument are simplified; in addition, the same instrument can be used for completing the puncture and the anchoring of the valve leaflets, so that the operation steps are reduced, the operation process is simplified, and the operation time is saved.

It will be appreciated that the interventional artificial chordae implantation system 9 of the invention may also be adapted for use in a scenario, for example, the artificial chordae tendineae implantation is performed via a path of jugular vein-superior vena cava-right atrium-interatrial septum-left atrium-mitral valve, the artificial chordae tendineae implantation is performed via a path of left atrium-mitral valve, and then, for example, the artificial chordae tendineae implantation is performed via a path of femoral vein-inferior vena cava-right atrium-tricuspid valve, the artificial chordae tendineae implantation is performed via a path of jugular vein-superior vena cava-right atrium-tricuspid valve, and the artificial chordae tendineae implantation is performed via a path of right atrium-tricuspid valve.

Referring to fig. 24 to 26, the interventional artificial chordae implantation system according to the second embodiment of the present invention is similar to the interventional artificial chordae implantation system 9 according to the first embodiment, except that: in a second embodiment, the anchor 271 is a self-expanding anchor, the distal end of the first pusher 273 abuts the proximal end of the anchor 271, the first pusher 273 can push the anchor 271 directly out of the distal end of the puncture needle 25, and the anchor 271 automatically expands to anchor into the ventricular wall or papillary muscle. Compared with the first embodiment, in the second embodiment, the first pushing member 273 is directly abutted to the anchor 271 without a connecting part, so that the position-limiting member 275 can be omitted, the overall structure of the interventional artificial chordae implantation system can be simplified, and the cost can be saved.

Specifically, as shown in fig. 24-26, in the second embodiment, the anchor 271 includes a shank 2717 and at least one anchor piece 2719 connected to the shank 2717. Preferably, the number of anchor pieces 2719 is set to be plural, which is advantageous in increasing the anchoring force of the anchor 271. The nail body 2717 is of an annular structure, a plurality of anchor pieces 2719 are arranged at intervals on the proximal end of the nail body 2717 along the circumferential direction of the nail body 2717, and the proximal end (i.e. the end far away from the nail body 2717) of each anchor piece 2719 is a sharp end. Further preferably, the plurality of anchor pieces 2719 are uniformly spaced along the circumferential direction of the nail body 2717, and in the process of anchoring the plurality of anchor pieces 2719 into the ventricular wall or papillary muscle, the acting force of the ventricular wall or papillary muscle on the anchor 271 by the plurality of anchor pieces 2719 is relatively balanced, which is beneficial to improving the anchoring stability of the anchor 271.

It should be noted that, in the second embodiment, at least the anchor piece 2719 of the anchor 271 is made of a shape memory material through heat setting treatment, preferably a nickel-titanium alloy, and the anchor piece 2719 is curved in a free state and can be elastically deformed to be flat when the anchor piece 2719 is subjected to an external force. Specifically, referring to fig. 24 and 25, before the anchor 271 is pushed out of the distal end of the piercing needle 25 by the first pusher 273, the plurality of anchor blades 2719 are restricted by the piercing needle 25 to be in a relatively closed state; referring to fig. 24 and 26, after the anchor 271 is pushed out of the distal end of the piercing needle 25 by the first pushing member 273, the plurality of anchor pieces 2719 are deployed, and the sharp end of each anchor piece 2719 is bent outward toward the nail body 2717 to be anchored into the ventricular wall or papillary muscle.

In using the interventional artificial chordae tendineae implantation system provided in the second embodiment, after the insertion needle 25 and the anchor 271 inside it have passed through the leaflets, the insertion needle 25 continues to be advanced distally until the insertion needle 25 penetrates the ventricular wall or papillary muscle, and the anchor tag 2719 is deployed to anchor in the ventricular wall or papillary muscle by pushing the first pusher 273 distally or withdrawing the insertion needle 25 proximally so that the self-expanding anchor 271 extends out of the distal end of the insertion needle 25.

Optionally, in other embodiments, the distal end of the spike body 2717 is a sharp end, and the anchoring assembly 27 further comprises an intermediate member movably disposed within the penetrating needle 25, the anchor 271 and the first pusher 273 being movably disposed within the intermediate member. When the interventional artificial chordae tendineae implantation system provided by the embodiment is used, the pushing of the puncture needle 25 is stopped after the puncture needle punctures the valve leaflets, then the middle piece and the first pushing piece 273 are synchronously pushed until the middle piece abuts against the ventricular wall or papillary muscle, the pushing of the middle piece is stopped, only the first pushing piece 273 is pushed, the anchor 271 is pushed out of the distal end of the middle piece, the sharp end of the nail body 2717 of the anchor 271 penetrates into the ventricular wall or papillary muscle, and the anchor sheet 2719 is unfolded and anchored into the ventricular wall or papillary muscle, so that the artificial chordae tendineae 10 is anchored on the ventricular wall or papillary muscle.

The intermediate piece is a hollow tube body, has certain rigidity and flexibility, and can be made of a metal material or a high polymer material with good biocompatibility, such as nickel titanium or Peek.

Further, it is also different from the first embodiment in that: in the second embodiment, the nail body 2717 of the ring structure is provided with a receiving cavity (not shown) which is fixedly connected with a pin 2712 extending along the radial direction, the artificial chordae tendineae 10 are folded in half, and the folded parts of the artificial chordae tendineae 10 bypass the pin 2712, so that the artificial chordae tendineae 10 are connected with the anchoring nail 271. In the second embodiment, the doubled artificial chordae 10 is anchored to the papillary muscle or myocardium by anchors 271, which is equivalent to the implantation of two artificial chordae 10.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims (10)

1. An interventional artificial chordae implantation system is characterized by comprising an artificial chordae and an artificial chordae implantation device;

the artificial chordae tendineae implanting device comprises a sheath tube, a clamping assembly, a puncture needle and an anchoring assembly;

the clamping assembly comprises a near-end clamping head and a far-end clamping head which are oppositely opened and closed, wherein the near-end clamping head is fixedly connected to the far end of the sheath tube, and a channel which is axially through and penetrates through the side wall of the far-end clamping head is arranged on the far-end clamping head;

the puncture needle is movably arranged in the sheath tube and the near-end chuck in a penetrating way and can penetrate into the far-end chuck through the channel;

the anchoring component comprises an anchor and a first pushing component detachably connected with the anchor, and the first pushing component is movably arranged in the puncture needle in a penetrating way and pushes the anchor out of the far end of the puncture needle;

the artificial chordae tendineae movably penetrate through the first pushing piece, and the far end of the artificial chordae tendineae is connected with the anchor.

2. The interventional artificial chordae implantation system of claim 1, wherein the anchor has a first connection portion at a proximal end thereof, the first pusher has a second connection portion at a distal end thereof corresponding to the first connection portion, and the first connection portion and the second connection portion have complementary and interlocking protrusions and recesses, respectively.

3. The interventional artificial chordae implantation system of claim 2, wherein the anchor assembly further comprises a stop;

the limiting piece is axially and movably arranged in the first pushing piece in a penetrating manner, and the far end of the limiting piece is inserted into or pulled out of the first connecting part and the second connecting part;

or the limiting part is movably sleeved outside the first pushing part, and the far end of the limiting part is wrapped around or exposed outside the first connecting part and the second connecting part.

4. The interventional artificial chordae implantation system of any one of claims 1-3, wherein the anchor comprises a hub and a helical screw connected to a distal end of the hub, the distal end of at least one of the artificial chordae being fixedly connected to the hub; the first pushing member abuts against the proximal end of the nail seat and drives the anchor to rotate.

5. The interventional artificial chordae implantation system of claim 1, wherein the anchor comprises a nail body and at least one self-expanding anchor blade connected to the nail body, the distal end of the first pusher abutting a proximal end of the nail body.

6. The interventional artificial chordae implantation system of claim 1, wherein the anchor comprises a nail body and at least one self-expanding anchor blade connected to the nail body, and wherein a distal end of the nail body is a sharp end and a distal end of the first pusher abuts a proximal end of the nail body;

the anchoring component further comprises an intermediate piece movably arranged in the puncture needle in a penetrating mode, and the anchor and the first pushing piece are movably arranged in the intermediate piece in a penetrating mode.

7. The interventional artificial chordae implantation system of claim 1, wherein the channel comprises a first slot running axially through and around an axis of the distal collet and a second slot communicating with the first slot and running through a sidewall of the distal collet.

8. The interventional artificial chordae implantation system of claim 7, wherein the first channel has an arc cross-sectional shape with a corresponding central angle greater than or equal to 180 degrees and a diameter greater than or equal to the diameter of the puncture needle; the cross section of the second groove body is rectangular, and the width of the rectangle is equal to or smaller than the diameter of the puncture needle and larger than the diameter of the artificial chordae tendineae.

9. The interventional artificial chordae implantation system of claim 1, further comprising a spacer sleeved over the artificial chordae and a second pusher having a distal end abutting the spacer, the second pusher being configured to push the spacer along the artificial chordae; 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 that of the puncture needle.

10. The interventional artificial chordae implantation system of claim 9, further comprising a locking device for positioning an end of the artificial chordae distal to the anchor to the spacer.

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