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 implantation system

technical field

The invention relates to the technical field of medical devices, in particular to an interventional artificial tendon chord implantation system.

Background technique

The mitral valve is a one-way valve between the left atrium and the left ventricle that allows blood to flow from the left atrium to the left ventricle. As shown in FIG. 1 , a normal healthy mitral valve 1 can control the flow of blood from the left atrium 2 to the left ventricle 3 while preventing the flow of blood 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 1b. The anterior lobe 1a and the posterior lobe 1b are fixed to the papillary muscle of the left ventricle 3 through their chordae tendineae 4, respectively. Under normal circumstances, when the left ventricle 3 contracts, the edges of the anterior lobe 1a and the posterior lobe 1b are completely aligned, 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 is partially ruptured, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 will be misaligned. Therefore, when the left ventricle 3 contracts, the mitral valve 1 It cannot be fully closed, 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, chordae tendineopathy can be treated by surgically implanting sutures as artificial chordae tendineae, but it requires invasive thoracotomy technique, general anesthesia and moderate hypothermic cardiopulmonary bypass as auxiliary support. The operation process is complicated and the cost is high. Moreover, patients suffer from high levels of trauma, high risk of complications, and painful recovery.

Another treatment option is to implant sutures as artificial chordae tendineae in a minimally invasive way. For example, through a transapical approach, a suture is implanted on the surface of the mitral valve leaflet on the left atrial side as an artificial chordae tendineae to maintain the pull of the ventricular wall on the valve leaflet. An existing transapical artificial chordae implantation device includes a proximal end collet and a distal end collet that can be opened and closed relative to each other to clamp the valve leaflets, the distal end collet is preset with a sleeve, and the sleeve The barrel is fixed with sutures, and a puncture needle is arranged in the proximal end collet. As shown in Figure 3, the puncture needle 5 passes through the valve leaflet 6 and then penetrates into the inside of the sleeve 7 and is connected with the locking structure inside the sleeve 7. The puncture needle 5 is withdrawn to drive the sleeve 7 and the suture 8 connected to the sleeve 7 to pass through the valve leaflet 6 to realize the implantation of the artificial chordae tendineae. However, on the one hand, this existing artificial chordae tendineae implantation system needs to set a sleeve in the distal chuck, and connect the sleeve after the puncture needle punctures the valve leaflet, so that the connection between the puncture needle and the suture can be realized, and the structure is relatively complicated; On the other hand, an additional fixation system needs to be replaced to fix the suture to the apex, ventricular wall, or papillary muscle, which is a complicated and time-consuming procedure.

SUMMARY OF THE INVENTION

In order to solve the above technical problems, the present invention provides an interventional artificial chordae tendineae implantation system, which has a simple structure and simple operation, which is beneficial to simplify the operation process and save the operation time.

The artificial tendon chord implantation system provided by the present invention includes an artificial tendon chord and an artificial tendon chord implantation device. The artificial chordae tendineae implantation device includes a sheath tube, a clamping component, a puncture needle and an anchoring component. The clamping assembly includes a proximal collet and a distal collet that are relatively open and close, wherein the proximal collet is fixedly connected to the distal end of the sheath, and the distal collet is provided with an axial A channel extends through and through the sidewall of the distal collet. The puncture needle is movably passed through the sheath tube and the proximal collet and can penetrate into the distal collet through the channel. The anchor assembly includes an anchor and a first pusher detachably connected to the anchor, the first pusher is movably penetrated into the puncture needle and pushes the anchor out of the puncture needle. remote. The artificial tendon is movably passed through the first pushing member, and the distal end thereof is connected to the anchor.

In the interventional artificial chordae tendineae implantation system provided by the present invention, an anchoring component is movably passed through the puncture needle, and a channel penetrating axially and penetrating the side wall of the distal end collet is arranged on the distal collet for the puncture needle to move through. The valve leaflet is clamped by the clamping assembly therein, the valve leaflet is punctured by the puncture needle and the anchoring assembly in it, and then the anchor is pushed out of the puncture needle and the distal collet through the first pusher until the anchor is anchored into the ventricle wall or papillary muscle so that the artificial chordae tendineae connected to the needle are anchored to the ventricular wall or papillary muscle by means of anchors. Compared with the prior art, the arrangement of the sleeve in the distal collet is omitted, the puncture needle only needs to puncture the valve leaflet, and the operation of cooperating and forming the connection between the puncture needle and the sleeve is not required, which simplifies the device structure and operation process; in addition, The valve leaflet puncture and anchor fixation can be completed by using the same set of instruments, and the operation steps are reduced, which is beneficial to simplify the operation process and save the operation time.

Description of drawings

In order to explain the technical solutions of the embodiments of the present invention more clearly, the following will briefly introduce the accompanying drawings that need to be used in the implementation manner. Obviously, the accompanying drawings in the following description are some embodiments of the present invention. As far as technical personnel are concerned, other drawings can also be obtained based on these drawings without any creative effort.

Figure 1 is a schematic view of the mitral valve in its normal state.

Figure 2 is a schematic view of the mitral valve in a state of insufficiency.

FIG. 3 is a schematic diagram of the puncturing process of the artificial chordae tendineae implantation device in the prior art.

FIG. 4 is a schematic partial three-dimensional structure diagram of the interventional artificial chordae tendineae implantation system provided by the first embodiment of the present invention.

FIG. 5 is a schematic three-dimensional structural diagram of the interventional artificial chord implantation system shown in FIG. 4 when the clamping assembly is opened.

FIG. 6 is a partial axial cross-sectional view of the interventional artificial chord implantation system shown in FIG. 4 .

FIG. 7 is an enlarged schematic view of part VII shown in FIG. 6 .

FIG. 8 is a schematic three-dimensional structural diagram of the distal collet connecting drive rod shown in FIG. 4 .

FIG. 9 is a schematic view of the end of the distal collet connecting the drive rod shown in FIG. 8 .

FIG. 10 is a schematic three-dimensional structural diagram of the artificial chordae tendineae and the anchoring assembly in FIG. 6 .

FIG. 11 is a schematic exploded perspective view of the artificial chordae tendineae and the anchoring assembly shown in FIG. 10 .

12 to 23 are schematic diagrams of the use process of the interventional artificial chord implantation system;

Wherein, Figure 12 illustrates the clamping assembly clamping the leaflets;

Fig. 13 is the enlarged schematic diagram of XIII part in Fig. 12;

Figure 14 illustrates the puncture needle and the anchoring assembly within the puncture leaflet;

Figure 15 is a schematic cross-sectional view of Figure 14;

Figure 16 illustrates the anchoring assembly passing through the needle and distal collet;

Figure 17 is a schematic cross-sectional view of Figure 16;

Figure 18 illustrates the separation of the first pusher in the anchor assembly from the anchor;

Figure 19 is a schematic cross-sectional view of Figure 18;

Figure 20 illustrates the anchoring of the anchor into the papillary muscle;

Figure 21 shows that the interventional artificial chord implantation system is withdrawn from the body except for the anchor and the artificial chord;

Figure 22 illustrates the shim being pushed to the leaflets;

Figure 23 illustrates the locking device securing the artificial chordae to the side of the spacer away from the leaflets.

24 is an axial cross-sectional view of the anchoring assembly and the distal end portion of the puncture needle of the interventional artificial chordae tendineae implantation system provided by the second embodiment of the present invention.

FIG. 25 is a schematic three-dimensional structural diagram of the anchor in FIG. 24 when the artificial chordae tendineae are connected and the anchor pieces of the anchor are in a closed state.

FIG. 26 is a schematic three-dimensional structural diagram of the anchor shown in FIG. 25 when the artificial chordae is connected and the anchor piece of the anchor is in a deployed state.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to 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, but not 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.

Furthermore, the following descriptions of the various embodiments refer to the accompanying drawings to illustrate specific embodiments in which the invention may be practiced. Directional terms mentioned in the present invention, such as "up", "down", "front", "rear", "left", "right", "inside", "outside", "side", etc., only Reference is made to the directions of the accompanying drawings, therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the system or element referred to must have a particular orientation, be configured in a particular orientation and operation, and therefore should not be construed as limiting the present invention.

It should be noted that, in order to more clearly describe the structure of the interventional suture implantation system and the interventional chord implantation system, the defined terms “proximal end” and “distal end” described in the specification of the present invention refer to interventional medical Domain terminology. Specifically, the "distal end" refers to the end away 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 central axis of rotation of objects such as cylinders and tubes is defined as the axial direction. The circumferential direction is the direction (perpendicular to the axis and perpendicular to the radius of the section) around the axis of objects such as cylinders and tubes. Radial is the direction of a straight line along a diameter or radius. Unless otherwise defined, 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 conventional terms used in the specification of the present invention are only for the purpose of describing specific embodiments, and should not be construed as limiting the present invention.

Please refer to FIG. 4 to FIG. 7 together. The interventional artificial chord implantation system 9 provided by the first embodiment of the present invention includes an artificial chord 10 and an artificial chord implantation device 20, wherein the artificial chord implantation device 20 includes a sheath 21 , a clamping assembly 23 , a puncture needle 25 and an anchoring assembly 27 .

Specifically, as shown in FIGS. 4 and 5 , the clamping assembly 23 includes a proximal collet 232 and a distal collet 234 that can be opened and closed relative to each other, and the proximal collet 232 is fixedly connected to the distal end of the sheath tube 21; As shown in FIG. 6 and FIG. 7 , the puncture needle 25 is movably passed through the sheath tube 21 and the proximal end collet 232 , and the distal end collet 234 is provided with a channel 238 which penetrates through the axial direction and penetrates through the side wall of the distal end collet 234 . , for the puncture needle 25 to be movably penetrated; as shown in FIG. 6 and FIG. 7 , the anchoring assembly 27 is movably arranged in the puncture needle 25, which includes an anchor 271 and a first pusher that is detachably connected to the anchor 271 273, the first pusher 273 is used to push the anchor 271 out of the distal end of the puncture needle 25; as shown in FIG. 6 and FIG. Attach anchor 271.

Further, as shown in FIG. 5 and FIG. 6 , the clamping assembly 23 further includes at least one driving rod 236 , the driving rod 236 is axially movably penetrated in the sheath tube 21 and the proximal end collet 232 , and the driving rod 236 is The distal end 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, thereby clamping the valve leaflet. It should be noted that the artificial chord implantation device 20 further includes a handle (not shown in the figure), the sheath tube 21, the driving rod 236, the puncture needle 25 and the proximal end of the first pusher 273 all extend outside the human body and are connected with the The handle is used to control the sheath tube 21, the drive rod 236, the puncture needle 25, the first pusher 273, etc., and the specific structure of the handle is not repeated here.

The artificial chord 10 as an implant has flexibility, that is, the artificial chord 10 can be arbitrarily bent without being stretched in the axial direction; in order to ensure the safety of implantation, the artificial chord 10 can be made of biocompatible It is made of good polymer materials, preferably PTFE, e-PTFE, PET and other polymer materials. In this embodiment, the artificial chordae tendineae 10 use e-PTFE sutures.

Please refer to FIG. 6 and FIG. 7 together, the proximal collet 232 and the distal collet 234 are both substantially cylindrical. Both the proximal collet 232 and the distal collet 234 can be made of polymer materials or metal materials with good biocompatibility, wherein the polymer materials include but are not limited to PP, PE, PET, PTFE, Pebax, One or more of PCs, the metal materials include but are 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 FIG. 7 , the proximal collet 232 can be fixedly connected to the distal end of the sheath tube 21 by any method such as screw connection, snap connection, adhesion or welding. The proximal collet 232 is provided with a hollow lumen extending through its two ends in the axial direction, and the hollow lumen is communicated with the lumen of the sheath tube 21; The cavity is located on one side of the hollow inner cavity and penetrates both ends of the proximal collet 232 in the axial direction. The drive rod cavity is used to movably pass through the drive rod 236 . shape to match.

Please refer to FIGS. 6 to 9 together, the distal collet 234 is fixedly connected to the distal end of the driving rod 236 , and the driving rod 236 is used to drive the distal collet 234 to open and close relative to the proximal collet 232 to clamp the valve leaflets.

Wherein, 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, in order to more effectively clamp the leaflet, at least one of the two clamping surfaces is provided with an anti-skid structure, and the anti-skid structure may be a concave-convex structure, a corrugated structure, etc., preferably a corrugated structure. Further preferably, in this embodiment, the two clamping surfaces (that is, the distal end surface of the proximal end collet 232 and the proximal end surface of the distal end collet 234 ) are inclined to the axial direction of the clamping assembly 23 , To facilitate leaflet entry and increase the area of the clamping surface.

As shown in FIG. 6 to FIG. 9 , the channel 238 includes a first groove body 2381 surrounding the axis of the distal collet 234 and passing through in the axial direction, and a side wall communicating with the first groove body 2381 and passing through the distal collet 234 The second groove body 2382. Specifically, as shown in FIG. 9 , the cross-sectional shape of the first groove body 2381 perpendicular to the axial direction of the distal end collet 234 is an arc shape, the central angle corresponding to the arc shape is greater than or equal to 180 degrees, and the first groove The diameter of the body 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 unobstructed after puncturing the valve leaflets. 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 shown in FIG. 9 , the cross-sectional shape of the second groove body 2382 perpendicular to the axial direction of the distal collet 234 is approximately a rectangle, 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 can be freely prolapsed from the distal collet 234 after passing through the valve leaflets and anchored to the ventricular wall or papillary muscle by the anchor 271, so that the artificial chordae tendineae 10 passing through the valve leaflets are not far away The restraint of the end collet 234 enables the distal collet 234 to be smoothly withdrawn from 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 .

Please refer to FIG. 6 and FIG. 7 together, the distal end of at least one driving rod 236 passes through the inner cavity of the sheath tube 21 and the driving rod cavity of the proximal collet 232 and passes through the distal end of the proximal collet 232, and then passes through the distal end of the proximal collet 232, and then communicates with the distal end of the proximal collet 232. The end collet 234 is connected for driving the distal collet 234 to open and close relative to the proximal end collet 232 . Wherein, the driving rod 236 is preferably made of nickel-titanium tube or nickel-titanium wire, and its cross-sectional shape can be any shape such as a circle, a rectangle or a triangle. It can be understood that the driving rod 236 with a rectangular or triangular cross-section will not rotate when moving axially in the inner cavity of the sheath tube 21 and the driving rod cavity of the proximal collet 232, so as to prevent the driving rod 236 from driving the distal end. During the opening and closing process of the collet 234 relative to the proximal collet 232 , the distal collet 234 rotates relative to the proximal collet 232 .

In other embodiments, a guide rod may be provided between the proximal collet 232 and the distal collet 234, the guide rod being parallel to the driving rod 236, wherein one end of the guide rod is fixedly connected to the proximal collet 232 and the distal collet 232. One of the end collets 234, the other end of the guide rod is slidably connected to the other one of the proximal end collet 232 and the distal end collet 234, whereby the driving rod 236 drives the distal end collet 234 to be opposite to the proximal end collet When the 232 is opened and closed, the guide rod can play a guiding role, and cooperate with the driving rod 236 to play a role of preventing rotation together, which can also prevent the distal collet 234 from rotating relative to the proximal collet 232 .

Please refer to FIG. 6 and FIG. 7 again, the puncture needle 25 is a hollow tubular body with certain rigidity and flexibility, and is preferably made of nickel-titanium material. The lumen of the puncture needle 25 is used for movably piercing the anchoring assembly 27 , and the distal end of the puncture needle 25 is a sharp end to facilitate puncturing the valve leaflets held by the proximal collet 232 and the distal collet 234 .

After the needle 25 is passed through the leaflet and into the channel 238 of the distal collet 234, the anchor assembly 27 can pass through the leaflet along with the needle 25, and then the first pusher 273 can push the anchor 271 out of the needle The needle 25 and distal collet 234 are used until the anchor 271 is anchored into the ventricular wall or papillary muscle, thereby anchoring the artificial chordae tendineae 10 attached to the anchor 271 to the ventricular wall or papillary muscle.

Specifically, please refer to FIG. 6 , FIG. 10 and FIG. 11 together. In this embodiment, the anchor 271 is a helical anchor, which includes a nail base 2713 and a helical nail body 2715 connected to the distal end of the nail base 2713 . The distal end of the artificial chordae 10 is fixedly connected to the nail seat 2713, and the screw body 2715 is rotated to be anchored into the ventricular wall or the papillary muscle, thereby anchoring the artificial chord 10 to the ventricular wall or the papillary muscle. The nail base 2713 and the screw body 2715 are made of metal materials with good biocompatibility, such as stainless steel.

The number of the artificial tendon chords 10 is at least one, and the nail base 2713 is fixedly connected by any method such as gluing, knotting or crimping. As shown in FIG. 6 , in this embodiment, the number of artificial chordae 10 is set to one, the nail base 2713 is provided with a through hole in the axial direction, and the distal end of the artificial chordae 10 passes through the through hole of the nail base 2713 and is drilled. The knot is fixed so that the wire knot cannot pass through the through hole of the nail base 2713 to form a fixed connection with the nail base 2713 . It should be noted that the proximal end of the artificial chordae 10 passes through the proximal end of the first pushing member 273 and extends to the outside of the human body, so as to facilitate subsequent locking and cutting.

As shown in FIG. 10 and FIG. 11 , the first pushing member 273 is a hollow tube body, which has certain rigidity and flexibility. The first pushing member 273 can be made of a metal material or a polymer material with good biocompatibility. For example Nitinol or Peek. In this embodiment, the first pusher 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 screw body 2715 is rotated and anchored into the ventricular wall or papillary muscle. Specifically, in this embodiment, the proximal end of the nail base 2713 is provided with a first connection portion 2711 , and the distal end of the first pusher 273 is provided with a second connection portion 2732 corresponding to the first connection portion 2711 . The first connection portion 2711 It is detachably connected with the second connecting part 2732, so that the anchor 271 is detachably connected with the first pushing member 273, so that the axial movement of the first pushing member 273 to the distal end can push the anchor 271 out of the distal end of the puncture needle 25. The rotation of the end and 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 to each other. For example, the concave-convex structure is S-shaped. The connecting parts 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 is connected with the second connecting portion 2732 , the interior thereof communicates with the inner cavity of the first pushing member 273 and the through hole of the nail base 2713 , so as to facilitate the passage of the artificial tendon 10 .

Further, as shown in FIGS. 10 and 11 , in this embodiment, the anchoring 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 body with certain rigidity and flexibility, and the limiting member 275 may be made of a metal material or polymer material with good biocompatibility, such as nickel titanium or Peek. Wherein, the materials of the first pushing member 273 and the limiting member 275 may be the same or different. In this example, the first pushing member 273 and the limiting member 275 are both NiTi tubes.

As shown in FIG. 10 , in one embodiment, the limiting member 275 is axially movably penetrated in the first pushing member 273 , and the limiting member 275 moves distally in the axial direction until its distal end is inserted into the first connecting portion 2711 and the inside of the second connecting portion 2732 can 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, so that the first pushing member 273 drives the anchor 271. Movement and rotation; the limiting member 275 moves toward the proximal end in the axial direction to its distal end and is pulled away from the interior of the first connecting portion 2711 and the second connecting portion 2732 , which can release its connection to the first connecting portion 2711 and the second connecting portion. 2732, so that the first pusher 273 can be separated from the anchor 271, so as to realize the release of the anchor 271.

In another embodiment, the limiting member 275 can be movably sleeved outside the first pushing member 273, and the limiting member 275 is moved to the distal end in the axial direction until the distal end of the limiting member 275 surrounds the first connecting portion 2711 and is connected to the second The outside of the first connecting part 2711 and the second connecting part 2732 can limit the separation of the first connecting part 2711 and the second connecting part 2732, so that the first pushing member 273 is connected to the anchor 271, so as to realize the movement and rotation of the anchor 271 driven by the first pushing member 273; The positioning member 275 moves proximally in the axial direction to its distal end to expose the outside of the first connecting portion 2711 and the second connecting portion 2732, which can release the restriction on the first connecting portion 2711 and the second connecting portion 2732, so that the first connecting portion 2711 and the second connecting portion 2732 can be released. The pusher 273 can be separated from the anchor 271 to achieve the release of the anchor 271 . It can be understood that, compared with placing the limiting member 275 inside the first pushing member 273 , setting the limiting member 275 outside the first pushing member 273 will increase the diameter of the puncture needle 25 . The piece 275 is inserted into the first push piece 273 .

In this embodiment, the interventional artificial chord implantation system 9 further includes a spacer, a second pushing member and a locking device (not shown). After the artificial chord 10 is anchored on the ventricular wall or the papillary muscle, the spacer and the second pusher are sleeved on the artificial chord 10, and the distal end of the second pusher abuts the spacer It is used to push the washer along the artificial chordae 10 to fit the valve leaflet, and the locking device is used to position the end of the artificial chord 10 away from the anchor 271 to the end of the washer away from the valve leaflet. on one side, thereby completing the locking fixation of the artificial chordae 10.

Wherein, the second pushing member is a hollow tube body with certain rigidity and flexibility, and the second pushing member can be made of a metal material or polymer material with good biocompatibility, such as nickel titanium 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. Preferably, the diameter of the through hole is smaller than the diameter of the puncture needle 25, so that the gasket can cover the puncture opening on the valve leaflet after being attached to the valve leaflet, compensate for the damage of the valve leaflet, reduce the risk of blood leakage, and The force acting on the valve leaflets by the artificial chordae tendineae 10 can be dispersed, which is beneficial to reduce the risk of tearing the valve leaflets by the artificial chordae tendineae 10.

In addition, it should be noted that the interventional artificial chorda tendineae implantation system 9 further includes an introducer sheath (not shown), the sheath tube 21 is axially movably penetrated in the introducer sheath, and the introducer sheath The distal end of the guide sheath is provided with at least one bendable section or pre-shaped section, which can bend the distal end of the introducer sheath, so that the introducer sheath can pass through the complex lumen structure of the human body along the guide wire. 21 and its distal clamping assembly 23 can pass through the lumen of the introducer sheath to the vicinity of the intended treatment site.

Please refer to FIG. 12 to FIG. 23 together. The following uses transcatheter mitral valve chordae tendineae repair as an example to describe the use process of the interventional artificial chordae tendineae implantation system 9 provided by the present invention. Among them, the interventional path of the operation is: through the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral valve.

The first step: puncture through the femoral vein, send the guide wire to the right atrium, and then puncture the fossa ovalis of the atrial septum with instruments such as an atrial septal puncture needle, and send the guide wire from the right atrium to the left atrium to reach the vicinity of the mitral valve , thereby establishing a pathway from in vitro to in vivo.

Step 2: The guide sheath is transported along the guide wire to the vicinity of the mitral valve, the guide wire is removed to retain the shown guide sheath, and the artificial chordae tendineae are implanted into the inner cavity of the guide sheath The distal portion of the sheath 21 and gripping assembly 23 are delivered to the vicinity of the mitral valve.

Step 3: Control the drive rod 236 to move distally to drive the distal collet 234 to open relative to the proximal collet 232, and adjust the position and bending angle of the distal end portion of the sheath 21 until the valve leaflet 6 enters the proximal collet 232 The gap with the distal collet 234, and then the drive rod 236 is controlled to move proximally to drive the distal collet 234 to close relative to the proximal collet 232, so that the leaflet 6 is clamped between the proximal collet 232 and the distal collet 232. between the end clamps 234 (as shown in Figures 12 and 13).

The fourth step: push the puncture needle 25 and the anchor assembly 27 at the same time, so that the distal end of the anchor assembly 27 passes through the valve leaflet 6 ( 14 and 15).

Step 5: Push the first pusher 273 and the limiter 275 in the anchoring assembly 27 synchronously, so that the anchoring assembly 27 extends out of the puncture needle 25 and the distal chuck 234 until it reaches the papillary muscle or the ventricular wall (eg, near the ventricular wall). 16 and 17).

The sixth step; by rotating the first pusher 273, the anchor 271 is driven to rotate, so that the screw body 2715 is anchored into the papillary muscle or the ventricular wall, and then the artificial chordae tendineae 10 is anchored on the papillary muscle or the ventricular wall, and then to the proximal end. Move the limiting member 275 to separate the first pushing member 273 from the anchor 271 to release the anchor 271 (as shown in FIG. 18 and FIG. 19 ); at this time, the proximal collet 232 and the distal collet 234 are still The leaflet 6 is clamped, as shown in FIG. 20 .

Step 7: Move the puncture needle 25, the first pushing member 273 and the limiting member 275 to the proximal end until they are separated from the valve leaflet 6 clamped by the proximal end collet 232 and the distal end collet 234, and then control the driving rod 236 again Move to the distal end to drive the distal collet 234 to open relative to the proximal collet 232, and then make the artificial chord 10 come out from the channel 238 of the distal collet 234, and remove the artificial chord implantation device 20; The chordae tendineae 10 pass through the valve leaflets 6, and the distal ends are fixed to the papillary muscle or the ventricular wall by anchors 271, and the proximal ends extend outside the patient's body, as shown in FIG. 21 .

The eighth step; as shown in Figure 22, the gasket 30 and the second pusher 40 are respectively sleeved on the artificial chordae 10, and the gasket 30 is pushed into the left atrium along the artificial chordae 10 through the second pusher 40. , until the spacer 10 contacts the leaflet 6 .

The ninth step: as shown in FIG. 23, the artificial chordae tendineae 10 are locked and fixed to the side of the gasket 30 away from the leaflet 6 by the locking device 50, and the excess artificial chordae tendineae 10 on the proximal side of the gasket 30 are cut off to complete Artificial chordae tendineae 10 are implanted. It can be understood that, in this step, the artificial chordae tendineae 10 can also be locked and fixed by knotting.

In the interventional artificial chordae tendineae implantation system 9 provided by the present invention, the anchor assembly 27 is movably passed through the puncture needle 25 , and the distal collet 234 is provided with a channel penetrating through the axial direction and passing through the side wall of the distal collet 234 238 is for the puncture needle 25 to be movably penetrated, the valve leaflet is clamped by the clamping component 23, the valve leaflet is punctured by the puncture needle 25 and the anchor component 27 in it, and then the anchor 271 is pushed out of the puncture needle 25 by the first pusher 273 and the distal collet 234 until the anchor 271 is anchored into the ventricular wall or the papillary muscle, so that the artificial chordae tendineae 10 connected with the puncture needle 25 is anchored to the ventricular wall or the papillary muscle by means of the anchor 271 . Compared with the prior art, it is omitted to set a sleeve in the distal collet, the puncture needle 25 only needs to puncture the valve leaflet, and the operation of the puncture needle and the sleeve to cooperate and form a connection is not required, which simplifies the structure of the instrument and the operation process; The valve leaflet puncture and anchor fixation can be completed by using the same set of instruments, and the operation steps are reduced, which is beneficial to simplify the operation process and save the operation time.

It can be understood that the interventional artificial chordae tendineae implantation system 9 of the present invention can also be applied to the following scenarios. Implantation of prosthetic chordae tendineae of catheter-interventional mitral valve, transatrial interventional mitral valve prosthetic chordae implantation through the route of left atrium-mitral valve, for example, transfemoral vein-inferior vena cava-right atrium - Transcatheter interventional tricuspid valve prosthetic chordae implantation through the tricuspid valve route, transcatheter interventional tricuspid valve prosthetic chordae implantation through the jugular vein-superior vena cava-right atrium-tricuspid valve route The artificial chordae tendineae implantation of the transatrial interventional tricuspid valve is performed through the route of entering and passing through the right atrium-tricuspid valve, which will not be repeated here. The transcatheter intervention method causes less damage to the human body than the transatrial method.

Please refer to FIG. 24 to FIG. 26 together. The structure of the interventional artificial chord implantation system provided by the second embodiment of the present invention is similar to that of the interventional artificial chord implantation system 9 provided by the first embodiment. The difference is that : In the second embodiment, the anchor 271 is a self-expanding anchor, the distal end of the first pusher 273 abuts against the proximal end of the anchor 271 , and the first pusher 273 can directly push the anchor 271 out of the puncture needle 25 The distal end of the anchor 271 self-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 in direct contact with the anchor 271, and no connecting portion is required, so that the limiting member 275 can be omitted, which is beneficial to simplify the interventional artificial chordae tendineae The overall structure of the implanted system saves costs.

Specifically, as shown in FIGS. 24 to 26 , in the second embodiment, the anchor 271 includes a nail body 2717 and at least one anchor piece 2719 connected to the nail body 2717 . Preferably, the number of anchor pieces 2719 is set to be multiple, which is beneficial to increase the anchoring force of the anchor pins 271 . The nail body 2717 has a ring-shaped structure, and a plurality of anchor pieces 2719 are arranged at the proximal end of the nail body 2717 at intervals along the circumferential direction of the nail body 2717 . sharp end. Further preferably, a plurality of anchor pieces 2719 are evenly spaced along the circumference of the nail body 2717. During the process of anchoring the plurality of anchor pieces 2719 into the ventricular wall or the papillary muscle, the ventricular wall or the papillary muscle acts on the ventricular wall or the papillary muscle through the plurality of anchor pieces 2719. The acting force of the anchor 271 is relatively balanced, which is beneficial to improve the anchoring stability of the anchor 271 .

It should be noted that, in the second embodiment, at least the anchor piece 2719 in the anchor 271 is made of a shape memory material through heat-setting, preferably a nickel-titanium alloy, and the anchor piece 2719 is curved in a free state. 2719 can be elastically deformed and become straight when subjected to external force. Specifically, please refer to FIG. 24 and FIG. 25 together, before the anchor 271 is pushed out of the distal end of the puncture needle 25 by the first pushing member 273, the anchor pieces 2719 are in a relatively closed state by the restriction of the puncture needle 25; 24 and 26, after the anchor 271 is pushed out of the distal end of the puncture needle 25 by the first pushing member 273, the anchor pieces 2719 are in a deployed state, and the sharp end of each anchor piece 2719 is bent outward toward the nail body 2717 at the same time , to anchor into the ventricular wall or papillary muscle.

When the interventional artificial chordae tendineae implantation system provided in the second embodiment is used, after the puncture needle 25 and its inner anchor 271 pass through the valve leaflet, the puncture needle 25 continues to advance distally until the puncture needle 25 penetrates the ventricle In the wall or papillary muscle, by pushing the first pusher 273 distally or withdrawing the puncture needle 25 proximally, so that the self-expanding anchor 271 protrudes from the distal end of the puncture needle 25, the anchor sheet 2719 is expanded to anchor in in the ventricular wall or in the papillary muscles.

Optionally, in other embodiments, the distal end of the nail body 2717 is a sharp end, the anchoring assembly 27 further includes a middle piece movably penetrated in the puncture needle 25, and the anchor 271 and the first pushing member 273 are movably penetrated through in the middleware. When using the interventional artificial chordae tendineae implantation system provided in this embodiment, the puncture needle 25 stops pushing the valve leaflet after puncturing the valve leaflet, and then pushes the middle piece and the first push piece 273 synchronously until the middle piece abuts the ventricle After the wall or papillary muscle, stop pushing the middle piece, only push the first pushing piece 273, push the anchor 271 out of the distal end of the middle piece, and the sharp end of the nail body 2717 of the anchor 271 pierces the ventricular wall or the papilla muscle, the anchor sheet 2719 is deployed and anchored into the ventricular wall or papillary muscle, thereby anchoring the artificial chordae tendineae 10 to the ventricular wall or papillary muscle.

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

In addition, the difference from the first embodiment is that in the second embodiment, the nail body 2717 of the annular structure is provided with an accommodating cavity (not shown), and the accommodating cavity is fixedly connected with a radially extending For the pin 2712 , the artificial chord 10 is folded in half, and the folded part of the artificial chord 10 bypasses the pin 2712 , so as to realize the connection between the artificial chord 10 and the anchor 271 . In the second embodiment, after the artificial chordae tendineae 10 folded in half is anchored to the papillary muscle or the myocardium through the anchor 271 , it is equivalent to the implantation of two artificial chordae tendineae 10 .

The above are the implementations of the embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the principles of the embodiments of the present invention, several improvements and modifications can also be made. These improvements and modifications are also It is regarded as the protection 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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