CN114681152B - Interventional artificial chord implantation system - Google Patents

Abstract

Translated fromChinese

本发明提供一种介入式人工腱索植入系统，包括人工腱索及人工腱索植入装置。人工腱索植入装置包括鞘管、夹持组件、穿刺针及锚定组件。夹持组件包括相对开合的近端夹头和远端夹头，其中，近端夹头固定连接于鞘管的远端，远端夹头上设有沿轴向贯通且穿通远端夹头侧壁的通道；穿刺针活动穿设于鞘管及近端夹头内并可经由通道穿入远端夹头；锚定组件包括锚钉及与锚钉可拆卸连接的第一推送件，第一推送件活动穿设于穿刺针内并将锚钉推出穿刺针的远端；人工腱索活动穿设于第一推送件内，且其远端连接锚钉。该介入式人工腱索植入系统，结构简单，操作简便，有利于简化手术过程及节省手术时间。

The present invention provides an interventional artificial chord implantation system, including artificial chords and an artificial chord implantation device. The artificial chord implantation device includes a sheath, a clamping assembly, a puncture needle and an anchoring assembly. The clamping assembly includes a proximal chuck and a distal chuck that open and close relatively, wherein the proximal chuck is fixedly connected to the distal end of the sheath, and the distal chuck is provided with a channel that penetrates axially and passes through the side wall of the distal chuck; the puncture needle is movably arranged in the sheath and the proximal chuck and can penetrate the distal chuck through the channel; the anchoring assembly includes an anchor and a first pushing member detachably connected to the anchor, the first pushing member is movably arranged in the puncture needle and pushes the anchor out of the distal end of the puncture needle; the artificial chord is movably arranged in the first pushing member, and its distal end is connected to the anchor. The interventional artificial chord implantation system has a simple structure and is easy to operate, which is conducive to simplifying the surgical process and saving surgical time.

Description

Interventional artificial tendon implantation system

Technical Field

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

Background

The mitral valve is a one-way valve between the left atrium and the left ventricle that ensures blood flow from the left atrium to the left ventricle. As shown in fig. 1, a normally healthy mitral valve 1 may 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, called anterior leaflet 1a and posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are each fixed to the papillary muscles of the left ventricle 3 by respective chordae tendineae 4. Normally, the left ventricle 3 contracts, and the edges of the anterior and posterior lobes 1a, 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 4 of the mitral valve 1 are partially ruptured, this will result in a poor apposition of the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1, whereby the mitral valve 1 cannot be fully closed when the left ventricle 3 is contracted, resulting in a regurgitation of blood from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

At present, surgical operation suture implantation can be used as an artificial chordae to treat chordae pathological changes, but an invasive chest opening technology is needed, general anesthesia and moderate low-temperature extracorporeal circulation are used as auxiliary supports, the operation process is complex, the cost is high, the patient is injured to a high degree, the complication risk is high, and the recovery process is painful.

Another treatment is to implant sutures as artificial chordae by minimally invasive means. For example, by implanting a suture on the surface of the left atrial side mitral valve leaflet via a transapical approach, the leaflet is maintained in tension by the ventricular wall as an artificial chordae tendineae. The existing artificial chorda tendineae implantation apparatus through the apex of the heart, its distal end includes proximal end chuck and distal end chuck that can open and shut relatively in order to grasp the lamella, have sleeve in the distal end chuck in advance, sleeve fixed connection suture, be equipped with the pjncture needle in the proximal end chuck, as shown in fig. 3, pjncture needle 5 penetrates sleeve 7 inside and links to each other with the inside locking structure of sleeve 7 after passing lamella 6, in order to drive sleeve 7 and the suture 8 that links to each other with sleeve 7 to pass lamella 6 through withdrawing pjncture needle 5 in order to realize artificial chorda tendineae implantation. However, this existing artificial chordae implantation system requires a sleeve in the distal collet, a connection sleeve after the needle pierces the valve leaflet to connect the needle with the suture, and is complex in structure, and on the other hand, an additional fixing system needs to be replaced to fix the suture to the apex, ventricular wall or papillary muscle, so that the surgical procedure is complex and time-consuming.

Disclosure of Invention

In order to solve the technical problems, the invention provides an interventional artificial tendon implantation system which has the advantages of simple structure and convenient operation, and is beneficial to simplifying the operation process and saving the operation time.

The invention provides an artificial tendon implantation system, which comprises an artificial tendon and an artificial tendon implantation device. The artificial tendon implantation device comprises a sheath tube, a clamping component, a puncture needle and an anchoring component. The clamping assembly comprises a proximal chuck and a distal chuck which are relatively opened and closed, wherein the proximal chuck is fixedly connected to the distal end of the sheath tube, and a channel which is axially penetrated and penetrates through the side wall of the distal chuck is arranged on the distal chuck. The puncture needle is movably arranged in the sheath tube and the proximal chuck in a penetrating way and can penetrate into the distal chuck through the channel. The anchoring assembly comprises an anchor and a first pushing piece detachably connected with the anchor, and the first pushing piece movably penetrates through the puncture needle and pushes the anchor out of the distal end of the puncture needle. The artificial tendon rope is movably arranged in the first pushing piece in a penetrating mode, and the distal end of the artificial tendon rope is connected with the anchor.

According to the interventional artificial tendon implantation system provided by the invention, the anchoring component is movably penetrated in the puncture needle, the channel which is penetrated in the axial direction and penetrates through the side wall of the distal chuck is arranged on the distal chuck for the puncture needle to movably penetrate, the clamping component clamps the valve leaflet, the valve leaflet is punctured by the puncture needle and the anchoring component therein, and then the anchor is pushed out of the puncture needle and the distal chuck through the first pushing piece until the anchor is anchored into the ventricular wall or papillary muscle, so that the artificial tendon connected with the puncture needle is anchored into the ventricular wall or papillary muscle by means of the anchor. Compared with the prior art, the device omits the sleeve arranged in the distal chuck, the puncture needle only needs to puncture the valve blade, the operation that the puncture needle is matched with the sleeve to form connection is not needed, the instrument structure and the operation process are simplified, in addition, the valve She Chuanci and the anchor nail can be fixed by using the same set of instrument, the operation steps are reduced, and the device is beneficial to simplifying the operation process and saving the operation time.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed 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 other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

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

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

Fig. 3 is a schematic illustration of a prior art penetration process of an artificial chorda implantation instrument.

Fig. 4 is a schematic view showing a partial perspective structure of an interventional type artificial tendon implantation system according to a first embodiment of the present invention.

Fig. 5 is a schematic perspective view of the interventional type artificial tendon implantation system of fig. 4 with the clamping assembly open.

Fig. 6 is a partial axial cross-sectional view of the interventional artificial chorda implantation system shown in fig. 4.

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

Fig. 8 is a schematic perspective view of the distal chuck coupling drive rod of fig. 4.

Fig. 9 is an end view of the distal chuck coupling drive rod shown in fig. 8.

Fig. 10 is a schematic perspective view of the artificial chordae and anchor assembly of fig. 6.

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

FIGS. 12-23 are schematic views of the use of the interventional artificial chorda implantation system;

wherein fig. 12 illustrates the clamping assembly clamping the leaflet;

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

FIG. 14 illustrates a needle and an anchor assembly penetrating a leaflet therein;

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

FIG. 16 illustrates the anchor assembly exiting the needle and distal cartridge;

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

Fig. 18 illustrates the first pusher in the anchor assembly separated from the anchor;

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

FIG. 20 illustrates anchoring of an anchor into papillary muscles;

FIG. 21 illustrates the insertion of the artificial tendon implant system outside the body, except for the anchors and artificial tendons;

FIG. 22 illustrates the pad being pushed onto the leaflet;

figure 23 illustrates a keying arrangement to lock the artificial chordae to the side of the spacer remote from the leaflet.

Fig. 24 is an axial cross-sectional view of an anchor assembly and a distal portion of a penetrating needle of an interventional type artificial chorda 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 attached to an artificial tendon with the anchor flaps of the anchor in a closed position.

Fig. 26 is a schematic perspective view of the anchor shown in fig. 25 attached to an artificial tendon with the anchor blades of the anchor in an expanded state.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without any inventive effort, are intended to be within the scope of the invention.

Furthermore, the following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional terms, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., in the present invention are merely referring to the directions of the attached drawings, and thus, directional terms are used for better, more clear explanation and understanding of the present invention, rather than indicating or implying that the system or element being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.

It should be noted that, in order to more clearly describe the structures of the interventional suture implantation system and the interventional chorda tendineae implantation system, the terms "proximal" and "distal" are defined in the specification as terms commonly used in the interventional medical field. Specifically, "distal" refers to the end that is distal from the operator during a surgical procedure, and "proximal" refers to the end that is proximal to the operator during a surgical procedure. The direction of the rotation center axis of the column, the tube, or the like is defined as the axial direction. The circumferential direction is the direction (perpendicular to the axis and also perpendicular to the radius of the cross section) around the axis of an object such as a cylinder, a pipe, etc. Radial is a straight 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, an interventional type artificial tendon implantation system 9 according to a first embodiment of the present invention includes an artificial tendon 10 and an artificial tendon implantation device 20, wherein the artificial tendon 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 comprises a proximal chuck 232 and a distal chuck 234 which can be opened and closed relatively, the proximal chuck 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 arranged in the sheath 21 and the proximal chuck 232, a channel 238 which penetrates through the side wall of the distal chuck 234 along the axial direction is arranged on the distal chuck 234 for the puncture needle 25 to movably penetrate therethrough, as shown in fig. 6 and 7, the anchoring assembly 27 is movably arranged in the puncture needle 25 and comprises an anchor 271 and a first pushing member 273 detachably connected with the anchor 271, the first pushing member is used for pushing the anchor 271 out of the distal end of the puncture needle 25, and as shown in fig. 6 and 7, the artificial tendon 10 is movably arranged in the first pushing member 273 and the distal end of the artificial tendon 10 is connected with 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 through the sheath 21 and the proximal chuck 232, and a distal end of the driving rod 236 is fixedly connected to the distal chuck 234, and the driving rod 236 moves axially to drive the distal chuck 234 to open and close relative to the proximal chuck 232, so as to clamp the valve leaflet. It should be noted that, the artificial tendon implantation device 20 further includes a handle (not shown in the drawings), and the proximal ends of the sheath 21, the driving rod 236, the puncture needle 25 and the first pushing member 273 are all extended outside the human body and connected to the handle, and the handle is used for controlling the sheath 21, the driving rod 236, the puncture needle 25 and the first pushing member 273, etc., so that detailed structures of the handle are not described herein.

The artificial tendon 10 as an implant has flexibility, that is, the artificial tendon 10 can be arbitrarily bent without being stretched in the axial direction, and the artificial tendon 10 may be made of a polymer material having good biocompatibility, preferably, a polymer material such as PTFE, e-PTFE, PET, etc., in order to secure the implant safety. In this embodiment, the artificial chordae 10 are suture with e-PTFE.

Referring to fig. 6 and 7, both the proximal collet 232 and the distal collet 234 are generally cylindrical. The proximal collet 232 and the distal collet 234 may each be made of a biocompatible polymeric material including, but not limited to, one or more of PP, PE, PET, PTFE, pebax, PC or a metallic material including, but not limited to, stainless steel, nitinol, etc. The materials of proximal collet 232 and distal collet 234 may be the same or different.

As shown in fig. 6 and 7, proximal clip 232 may be fixedly attached to the distal end of sheath 21 by any means such as a threaded connection, a snap fit connection, an adhesive, or a weld. In addition, the proximal chuck 232 is also provided with a driving rod cavity which is positioned at one side of the hollow cavity and axially penetrates through the two ends of the proximal chuck 232, the driving rod cavity is used for movably penetrating through 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 clamp 234 is fixedly connected to the distal end of the driving rod 236, and the driving rod 236 is used to drive the distal clamp 234 to open and close relative to the proximal clamp 232 to clamp the valve leaflet.

When the proximal collet 232 and the distal collet 234 clamp the leaflet, the distal end surface of the proximal collet 232 and the proximal end surface of the distal collet 234 are two clamping surfaces. Alternatively, in order to clamp the leaflet more effectively, at least one of the two clamping surfaces is provided with an anti-slip structure, which may be a concave-convex structure, a corrugated structure, or the like, preferably a corrugated structure. It is further preferred that in this embodiment, both gripping surfaces (i.e., the distal surface of proximal collet 232 and the proximal surface of distal collet 234) are disposed obliquely to the axial direction of gripping assembly 23 to facilitate leaflet access and increase the area of the gripping surfaces.

As shown in fig. 6-9, the channel 238 includes a first slot 2381 extending axially therethrough about the axis of the distal clamp 234 and a second slot 2382 communicating with the first slot 2381 and extending through a sidewall of the distal clamp 234. Specifically, as shown in fig. 9, a cross-section of the first groove 2381 perpendicular to the axial direction of the distal chuck 234 is arc-shaped, a central angle corresponding to the arc is greater than or equal to 180 degrees, and a diameter of the first groove 2381 is greater than or equal to a diameter of the puncture needle 25, so that the puncture needle 25 can conveniently puncture the leaflet and then enter the channel 238 without obstruction. 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 2382 perpendicular to the axial direction of the distal collet 234 is approximately 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 10 so that the artificial chordae 10 pass through the valve leaflet and are freely withdrawn from the distal collet 234 after being anchored to the ventricular wall or papillary muscle by the anchor 271, so that the artificial chordae 10 passing through the valve leaflet is not caught by the distal collet 234, thereby allowing the distal collet 234 to be smoothly withdrawn outside 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 inner cavity of the sheath 21 and the driving rod cavity of the proximal clamp 232, out of the distal end of the proximal clamp 232, and is then connected to the distal clamp 234 for driving the distal clamp 234 to open and close relative to the proximal clamp 232. The driving rod 236 is preferably made of a nitinol tube or wire, and may have any cross-sectional shape such as a circular shape, a rectangular shape, or a triangular shape. It will be appreciated that the drive rod 236 having a rectangular or triangular cross-section does not rotate when axially moved within the lumen of the sheath 21 and the drive rod lumen of the proximal collet 232, thereby preventing the drive rod 236 from rotating 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.

In other embodiments, a guide rod may be disposed between the proximal collet 232 and the distal collet 234, the guide rod being parallel to the drive 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 slidingly connected to the other of the proximal collet 232 and the distal collet 234, such that when the drive rod 236 drives the distal collet 234 to open relative to the proximal collet 232, the guide rod may perform a guiding function and cooperate with the drive rod 236 to perform a rotation stopping function together, and the distal collet 234 may be prevented from rotating relative to the proximal collet 232.

Referring again to fig. 6 and 7, the puncture needle 25 is a hollow tube body, which has a certain rigidity and flexibility, and is preferably made of nickel-titanium material. The lumen of the needle 25 is used to removably pierce the anchor assembly 27, with the distal end of the needle 25 being sharpened to facilitate penetration of the leaflets held by the proximal and distal jaws 232, 234.

After needle 25 passes through the leaflet and into passageway 238 of distal collet 234, anchor assembly 27 may be passed through the leaflet with needle 25, and then first pusher 273 may push anchor 271 out of needle 25 and distal collet 234 until anchor 271 anchors into the ventricular wall or papillary muscle, thereby anchoring artificial chordae 10 attached to anchor 271 to the ventricular wall or papillary muscle.

In particular, referring to fig. 6, 10 and 11, in the present embodiment, the anchor 271 is a screw anchor, which includes a seat 2713 and a screw body 2715 connected to a distal end of the seat 2713, the distal end of the artificial tendon 10 is fixedly connected to the seat 2713, and the screw body 2715 is rotated to anchor into the ventricular wall or papillary muscle, thereby anchoring the artificial tendon 10 to the ventricular wall or papillary muscle. The nail seat 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 10 is at least one, and the nail base 2713 is fixedly connected by any mode of bonding, 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 knotted and fixed, so that the knot cannot pass through the through hole of the nail base 2713, thereby forming a fixed connection with the nail base 2713. It should be noted that, the proximal end of the artificial tendon 10 passes through the proximal end of the first pushing member 273 and extends out of the human body, so as to facilitate subsequent locking, fastening and cutting.

As shown in fig. 10 and 11, the first pushing member 273 is a hollow tube body, which has a 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 nitinol or Peek. In this embodiment, first pusher 273 is used to push anchor 271 out of the distal end of needle 25 and to drive anchor 271 in rotation to rotationally anchor screw body 2715 into the ventricular wall or papillary muscle. Specifically, in the present embodiment, the proximal end of the nail seat 2713 is provided with a first connecting portion 2711, the distal end of the first pushing member 273 is provided with a second connecting portion 2732 corresponding to the first connecting portion 2711, and the first connecting portion 2711 and the second connecting portion 2732 are detachably connected, so that the anchor 271 and the first pushing member 273 are detachably connected, and further, the distal end of the anchor 271 can be pushed out of the distal end of the puncture needle 25 by the movement of the first pushing member 273 along the axial distal end, and the rotation of the first pushing member 273 can drive the anchor 271 to rotate. More specifically, in this embodiment, the first connecting portion 2711 and the second connecting portion 2732 are respectively provided with concave-convex structures with complementary shapes and spliced with each other, for example, the concave-convex structures are S-shaped, and the first connecting portion 2711 and the second connecting portion 2732 overlap with each other, so as to realize detachable connection of the anchor 271 and the first pushing member 273. When the first connecting portion 2711 is connected to the second connecting portion 2732, the inside thereof is communicated with the inner cavity of the first pushing member 273 and the through hole of the nail base 2713, so as to facilitate the artificial tendon 10 to pass through.

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 detachment of the first connecting portion 2711 from the second connecting portion 2732. Specifically, the limiting member 275 is a hollow tube body, has a certain rigidity and flexibility, and the limiting member 275 can be made of a metal material or a 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 nickel-titanium tubes.

As shown in fig. 10, in one embodiment, the limiting member 275 is movably disposed in the first pushing member 273 in an axial direction, the limiting member 275 moves distally in the axial direction until its distal end is inserted into the first connecting portion 2711 and the second connecting portion 2732, so as to limit the detachment 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 as to enable the first pushing member 273 to drive the anchor 271 to move and rotate, and the limiting member 275 moves proximally in the axial direction until its distal end is pulled away from the interiors of the first connecting portion 2711 and the second connecting portion 2732, so that the limitation of the limiting member 275 on 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, so as to enable the release of the anchor 271.

In another embodiment, the limiting member 275 can be movably sleeved outside the first pushing member 273, the limiting member 275 moves along the axial direction to the distal end to wrap the outer parts of 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 limited to be separated, the first pushing member 273 is connected to the anchor 271, the first pushing member 273 drives the anchor 271 to move and rotate, the limiting member 275 moves along the axial direction to the proximal end to expose the outer parts of the first connecting portion 2711 and the second connecting portion 2732, and the limitation of the limiting member 275 to the first connecting portion 2711 and the second connecting portion 2732 can be released, so that the first pushing member 273 can be separated from the anchor 271, and the release of the anchor 271 can be realized. It will be appreciated that the diameter of the puncture needle 25 is increased by sleeving the limiter 275 outside the first pushing member 273, compared to threading the limiter 275 inside the first pushing member 273, and therefore, it is preferable that the limiter 275 is threaded inside the first pushing member 273.

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

The second pushing member is a hollow tube body and has certain rigidity and flexibility, the second pushing member 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-shaped structure with certain thickness and size, the material of the gasket can be polyester cloth with good biocompatibility and other materials, the gasket is provided with a through hole for the artificial tendon 10 to movably pass through, and preferably, the diameter of the through hole is smaller than that of the puncture needle 25, so that the gasket can cover a puncture opening on the valve leaflet after being attached to the valve leaflet, the valve She Sunshang is made up, the blood leakage risk is reduced, the acting force of the artificial tendon 10 on the valve leaflet can be dispersed, and the risk of tearing the valve leaflet by the artificial tendon 10 is reduced.

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

Referring to fig. 12 to 23, the following describes the use of the interventional artificial chorda tendineae implantation system 9 according to the present invention, taking transcatheter mitral chordal repair as an example. The intervention route of the operation is via femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral valve.

The first step is to puncture the femoral vein, send the guide wire to the right atrium, puncture the oval fossa of the atrial septum by the apparatus such as the atrial septum puncture needle, send the guide wire from the right atrium to the left atrium, and reach the vicinity of the mitral valve, thereby establishing a passage from outside the body to inside the body.

The second step is to deliver the sheath along the guidewire to the vicinity of the mitral valve, withdraw the guidewire to retain the sheath, and deliver the distal portion of the sheath 21 and the clamping assembly 23 of the artificial chordae implant device 20 to the vicinity of the mitral valve through the lumen of the sheath.

Third, the drive rod 236 is controlled to move distally to bring the distal collet 234 open relative to the proximal collet 232, the position and angle of bending of the distal portion of the sheath 21 is adjusted 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 bring the distal collet 234 closed relative to the proximal collet 232, such that the leaflet 6 is clamped between the proximal collet 232 and the distal collet 234 (as shown in fig. 12 and 13).

Fourth, the needle 25 and the anchor assembly 27 are simultaneously advanced so that the distal end of the anchor assembly 27 passes along with the needle 25 through the leaflet 6 (as shown in fig. 14 and 15) held by the proximal and distal jaws 232, 234.

Fifth, the first pushing member 273 and stopper 275 of the anchor assembly 27 are simultaneously pushed so that the anchor assembly 27 extends out of the needle 25 and distal collet 234 until it reaches the papillary muscle or the vicinity of the ventricular wall (as shown in fig. 16 and 17).

In the sixth step, the first pushing member 273 is rotated to drive the anchor 271 to rotate, so that the spiral nail body 2715 is anchored to the papillary muscle or the ventricular wall, the artificial chordae 10 is anchored to 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 release of the anchor 271 is realized (as shown in fig. 18 and 19), and at this time, the proximal chuck 232 and the distal chuck 234 still clamp the valve leaflet 6, as shown in fig. 20.

Seventh, the puncture needle 25, the first pushing member 273 and the limiting member 275 are moved proximally to disengage from the leaflet 6 held by the proximal collet 232 and the distal collet 234, and then the driving rod 236 is controlled again to move distally to drive the distal collet 234 to open relative to the proximal collet 232, so that the artificial chordae 10 are pulled out of the channel 238 of the distal collet 234, and the artificial chordae implant device 20 is removed, at this time, the artificial chordae 10 pass through the leaflet 6 and the distal end is fixed to the papillary muscle or the ventricular wall by the anchor 271, and the proximal end extends outside the patient, as shown in fig. 21.

In the eighth step, as shown in fig. 22, the pad 30 and the second pushing member 40 are respectively sleeved on the artificial chordae 10, and the second pushing member 40 pushes the pad 30 into the left atrium along the artificial chordae 10 until the pad 10 contacts the leaflet 6.

Ninth, as shown in fig. 23, the artificial chordae 10 are locked and fixed on the side of the spacer 30 far from the valve leaflet 6 by the locking device 50, and the redundant artificial chordae 10 on the proximal side of the spacer 30 is cut off, thus completing the implantation of the artificial chordae 10. It will be appreciated that in this step, the artificial chordae 10 may also be secured by a knot.

According to the interventional artificial tendon implantation system 9 provided by the invention, the anchoring component 27 is movably penetrated in the puncture needle 25, the channel 238 which is penetrated in the axial direction and penetrates through the side wall of the distal chuck 234 is arranged on the distal chuck 234 for the puncture needle 25 to movably penetrate, the valve leaflet is clamped by the clamping component 23, the valve leaflet is punctured by the puncture needle 25 and the anchoring component 27 therein, and then the anchor 271 is pushed out of the puncture needle 25 and the distal chuck 234 through the first pushing part 273 until the anchor 271 is anchored in the ventricular wall or papillary muscle, so that the artificial tendon 10 connected with the puncture needle 25 is anchored in the ventricular wall or papillary muscle by means of the anchor 271. Compared with the prior art, the device omits the sleeve arranged in the distal chuck, the puncture needle 25 only needs to puncture the valve leaflet, the operation that the puncture needle is matched with the sleeve to form connection is not needed, the instrument structure and the operation process are simplified, in addition, the valve She Chuanci and the anchor nail can be fixed by using the same set of instrument, the operation steps are reduced, and the device is beneficial to simplifying the operation process and saving the operation time.

It will be appreciated that the interventional artificial chordae implantation system 9 of the present invention may also be adapted for use in situations such as transcatheter-superior vena cava-right atrium-atrial septum-left atrium-mitral valve access, transcatheter-mitral valve access, and transcatheter-inferior vena cava-right atrium-tricuspid valve access, and for example transcatheter-superior vena cava-right atrium-tricuspid access, transcatheter-tricuspid access, right atrium-tricuspid access, and transcatheter-tricuspid access, although not described in detail herein, with less trauma to the human body than the transatrial approach.

Referring to fig. 24 to 26 together, the interventional artificial tendon implantation system according to the second embodiment of the present invention is similar to the interventional artificial tendon implantation system 9 according to the first embodiment, in that in the second embodiment, the anchor 271 is a self-expanding anchor, the distal end of the first pushing member 273 abuts against the proximal end of the anchor 271, the first pushing member 273 can directly push the anchor 271 against the distal end of the puncture needle 25, and the anchor 271 is automatically expanded to anchor into the ventricle 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, and no connecting portion is required, so that the limiting member 275 can be omitted, the whole structure of the interventional artificial tendon implantation system is simplified, and the cost is saved.

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

In the second embodiment, at least the anchor piece 2719 of the anchor 271 is made of a shape memory material, preferably nickel-titanium alloy, and the anchor piece 2719 is bent in a free state, and can be elastically deformed to become flat when the anchor piece 2719 is subjected to an external force. Specifically, referring to FIGS. 24 and 25 together, before the anchor 271 is pushed out of the distal end of the needle 25 by the first pushing member 273, the plurality of anchor tabs 2719 are restrained by the needle 25 in a relatively closed state, and referring to FIGS. 24 and 26 together, after the anchor 271 is pushed out of the distal end of the needle 25 by the first pushing member 273, the plurality of anchor tabs 2719 are in an expanded state, and the sharp end of each anchor tab 2719 is simultaneously bent outwardly toward the staple body 2717 for anchoring into the ventricular wall or papillary muscle.

In using the interventional artificial chordae implantation system provided in the second embodiment, after the puncture needle 25 and the anchor 271 therein pass through the valve leaflet, the puncture needle 25 continues to be advanced distally until the puncture needle 25 penetrates into the ventricular wall or papillary muscle, by pushing the first pushing member 273 distally or withdrawing the puncture needle 25 proximally so that the distal end of the puncture needle 25 protrudes from the expandable anchor 271, the anchor 2719 expands to anchor into the ventricular wall or papillary muscle.

Optionally, in other embodiments, the distal end of the spike body 2717 is a sharp end, and the anchor assembly 27 further comprises an intermediate member movably disposed within the puncture needle 25, and the anchor 271 and the first pusher 273 are movably disposed within the intermediate member. In using the interventional artificial tendon implantation system provided in this embodiment, the pushing is stopped after the puncture needle 25 punctures the valve leaflet, and then the intermediate member and the first pushing member 273 are simultaneously pushed until the intermediate member abuts against the ventricular wall or papillary muscle, the pushing of the intermediate member is stopped, only the first pushing member 273 is pushed out of the distal end of the intermediate member, the sharp end of the pin body 2717 of the pin 271 pierces the ventricular wall or papillary muscle, and the anchor piece 2719 is spread and anchored to the ventricular wall or papillary muscle, thereby anchoring the artificial tendon 10 to the ventricular wall or papillary muscle.

The middle piece is a hollow pipe body and 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.

In addition, the second embodiment is different from the first embodiment in that the annular nail body 2717 is provided with a receiving cavity (not shown) fixedly connected with a pin 2712 extending in the radial direction, the artificial tendon 10 is doubled over, and the doubled-over part of the artificial tendon 10 bypasses the pin 2712, so that the artificial tendon 10 is connected with the anchor 271. In the second embodiment, after the doubled-over artificial chordae 10 are anchored to papillary muscles or cardiac muscles by the anchors 271, implantation of two artificial chordae 10 is equivalent.

The foregoing is a description of embodiments of the present invention, and it should be noted that, for those skilled in the art, modifications and variations can be made without departing from the principles of the embodiments of the present invention, and such modifications and variations are also considered to be within the scope of the present invention.

Claims (9)

Translated fromChinese

1.一种介入式人工腱索植入系统，其特征在于，包括人工腱索及人工腱索植入装置；1. An interventional artificial chord implantation system, comprising an artificial chord and an artificial chord implantation device;所述人工腱索植入装置包括鞘管、夹持组件、穿刺针、及锚定组件；The artificial tendon chord implantation device comprises a sheath, a clamping assembly, a puncture needle, and an anchoring assembly;所述夹持组件包括相对开合的近端夹头和远端夹头，其中，所述近端夹头固定连接于所述鞘管的远端，所述远端夹头上设有沿轴向贯通且穿通所述远端夹头侧壁的通道，所述通道包括围绕所述远端夹头的轴线且轴向贯通的第一槽体及连通于所述第一槽体并穿通所述远端夹头的侧壁的第二槽体；The clamping assembly comprises a proximal clamp and a distal clamp which are relatively open and closed, wherein the proximal clamp is fixedly connected to the distal end of the sheath tube, and the distal clamp is provided with a channel which runs axially through and through the side wall of the distal clamp, and the channel comprises a first groove body which surrounds the axis of the distal clamp and runs axially through, and a second groove body which is connected to the first groove body and passes through the side wall of the distal clamp;所述穿刺针活动穿设于所述鞘管及所述近端夹头内并可经由所述通道穿入所述远端夹头；The puncture needle is movably arranged in the sheath tube and the proximal clamp and can penetrate into the distal clamp through the channel;所述锚定组件包括锚钉及与所述锚钉可拆卸连接的第一推送件，所述第一推送件活动穿设于所述穿刺针内并将所述锚钉推出所述穿刺针的远端；The anchor assembly includes an anchor and a first pushing member detachably connected to the anchor, wherein the first pushing member is movably disposed in the puncture needle and pushes the anchor out of the distal end of the puncture needle;所述人工腱索活动穿设于所述第一推送件内，且其远端连接所述锚钉。The artificial tendon cord is movably arranged in the first pushing member, and the distal end thereof is connected to the anchor.2.如权利要求1所述的介入式人工腱索植入系统，其特征在于，所述锚钉的近端上设有第一连接部，所述第一推送件的远端对应所述第一连接部设有第二连接部，所述第一连接部与所述第二连接部上分别设有形状互补、互相拼接的凹凸结构。2. The interventional artificial chord implantation system as described in claim 1 is characterized in that a first connecting part is provided on the proximal end of the anchor, a second connecting part is provided at the distal end of the first pushing member corresponding to the first connecting part, and the first connecting part and the second connecting part are respectively provided with concave and convex structures with complementary shapes and spliced with each other.3.如权利要求2所述的介入式人工腱索植入系统，其特征在于，所述锚定组件还包括限位件；3. The invasive artificial chord implantation system according to claim 2, characterized in that the anchoring assembly further comprises a stopper;所述限位件轴向活动穿设于所述第一推送件内，所述限位件的远端插入或者抽离所述第一连接部与所述第二连接部的内部；The limiting member is axially movable and penetrates the first pushing member, and the distal end of the limiting member is inserted into or withdrawn from the first connecting portion and the second connecting portion;或者所述限位件活动套设于所述第一推送件外，所述限位件的远端包绕或者暴露所述第一连接部与所述第二连接部的外部。Alternatively, the limiting member is movably sleeved outside the first pushing member, and the distal end of the limiting member surrounds or exposes the exterior of the first connecting portion and the second connecting portion.4.如权利要求1-3任一项所述的介入式人工腱索植入系统，其特征在于，所述锚钉包括钉座及连接于所述钉座的远端的螺旋钉体，至少一根所述人工腱索的远端固定连接于所述钉座；所述第一推送件抵接所述钉座的近端并驱动所述锚钉旋转。4. The interventional artificial chord implantation system as described in any one of claims 1-3 is characterized in that the anchor includes a nail seat and a spiral nail body connected to the distal end of the nail seat, and the distal end of at least one artificial chord is fixedly connected to the nail seat; the first pushing member abuts the proximal end of the nail seat and drives the anchor to rotate.5.如权利要求1所述的介入式人工腱索植入系统，其特征在于，所述锚钉包括钉体及连接于所述钉体上的至少一个自膨式锚片，所述第一推送件的远端抵接所述钉体的近端。5. The interventional artificial chord implantation system as described in claim 1 is characterized in that the anchor comprises a nail body and at least one self-expanding anchor sheet connected to the nail body, and the distal end of the first pushing member abuts the proximal end of the nail body.6.如权利要求1所述的介入式人工腱索植入系统，其特征在于，所述锚钉包括钉体及连接于所述钉体上的至少一个自膨式锚片，且所述钉体的远端为尖锐端，所述第一推送件的远端抵接所述钉体的近端；6. The invasive artificial chord implantation system according to claim 1, wherein the anchor comprises a nail body and at least one self-expanding anchor sheet connected to the nail body, and the distal end of the nail body is a sharp end, and the distal end of the first pushing member abuts against the proximal end of the nail body;所述锚定组件还包括活动穿设于所述穿刺针内的中间件，所述锚钉及所述第一推送件活动穿设于所述中间件内。The anchoring assembly further comprises a middle piece movably disposed in the puncture needle, and the anchor nail and the first pushing member are movably disposed in the middle piece.7.如权利要求1所述的介入式人工腱索植入系统，其特征在于，所述第一槽体的横截面形状为弧形，所述弧形对应的圆心角大于或者等于180度，且所述第一槽体的直径大于或者等于所述穿刺针的直径；所述第二槽体的横截面形状为矩形，所述矩形的宽度等于或者小于所述穿刺针的直径并大于所述人工腱索的直径。7. The interventional artificial chord implantation system as described in claim 1 is characterized in that the cross-sectional shape of the first groove body is an arc, the central angle corresponding to the arc is greater than or equal to 180 degrees, and the diameter of the first groove body is greater than or equal to the diameter of the puncture needle; the cross-sectional shape of the second groove body is a rectangle, the width of the rectangle is equal to or less than the diameter of the puncture needle and greater than the diameter of the artificial chord.8.如权利要求1所述的介入式人工腱索植入系统，其特征在于，还包括套设于所述人工腱索上的垫片及第二推送件，所述第二推送件的远端抵接所述垫片，所述第二推送件用于推顶所述垫片沿所述人工腱索移动；所述垫片上设有供所述人工腱索活动穿过的通孔，所述通孔的直径小于所述穿刺针的直径。8. The interventional artificial chord implantation system as described in claim 1 is characterized in that it also includes a gasket and a second pushing member mounted on the artificial chord, the distal end of the second pushing member abuts against the gasket, and the second pushing member is used to push the gasket to move along the artificial chord; the gasket is provided with a through hole for the artificial chord to pass through, and the diameter of the through hole is smaller than the diameter of the puncture needle.9.如权利要求8所述的介入式人工腱索植入系统，其特征在于，还包括锁结装置，所述锁结装置用于将所述人工腱索远离所述锚钉的一端定位至所述垫片上。9. The invasive artificial chord implantation system as described in claim 8, characterized in that it also includes a locking device, wherein the locking device is used to position the end of the artificial chord away from the anchor pin onto the gasket.