CN115969575A - Artificial chordae tendineae and artificial chordae tendineae implantation system - Google Patents

Abstract

The application provides an artificial chordae tendineae and an artificial chordae tendineae implantation system. The artificial chordae tendineae include a clamping member and a flexible elongate member. The clamping piece comprises a first clamping section, a second clamping section and a bending section connected between the first clamping section and the second clamping section. The clamping piece at least has elasticity in the part of bending section, and the bending section is equipped with hollow out construction. First centre gripping section and second centre gripping section all include the free end of keeping away from the bending segment. Under the natural state, the free end of the first clamping section and the free end of the second clamping section are relatively close to each other. The flexible elongate member portion is connected to the clamping member. In this artifical chordae tendineae, because the bending section of holder is equipped with hollow out construction, both can improve the mechanical properties of holder, reduce and pull open the required pulling force of first centre gripping section and second centre gripping section, can also alleviate the weight of holder, improve the long-term fatigue resistance ability of implanting the human body of holder.

Description

Artificial chordae and artificial chordae implantation system

Technical Field

The application relates to the technical field of medical equipment, in particular to an artificial chordae tendineae and an artificial chordae tendineae implantation system.

Background

The leaflets of atrioventricular valves, such as the mitral valve and the tricuspid valve, are connected to the ventricular wall by chordae tendinae and papillary muscles. Lesions or rupture of chordae tendineae may cause atrioventricular valve insufficiency, resulting in regurgitation of blood. Blood reflux can significantly reduce the pump efficiency of the heart, placing the patient at risk of severe, progressive heart failure.

There are instruments for implanting artificial chordae tendineae in a minimally invasive manner by anchoring a clamping device to the leaflets, one end of the artificial chordae tendineae being attached to the clamping device and the other end to the myocardial wall or papillary muscle, so that the leaflets can be pulled during ventricular systole to avoid regurgitation. On the one hand, however, the pulling force required for operating the clamping device to open is too large, and the operation difficulty is large; on the other hand, the clamping device is heavy and tends to pull the valve leaflets, which may cause the valve leaflets to tear, and the clamping device may not endure fatigue.

Disclosure of Invention

For solving above-mentioned technical problem, this application provides an artificial chordae tendineae and artificial chordae tendineae implantation system, and the holder of this artificial chordae tendineae is provided with hollow out construction at its bending segment, both can improve the mechanical properties of holder, reduces to pull open the required pulling force of holder, can also alleviate the weight of holder, reduces the effect of drawing down to the leaflet to improve the long-term fatigue resistance ability of implanting the human body of holder.

In order to realize above-mentioned purpose, this application provides an artificial chordae tendineae on the one hand, including holder and flexible elongate member, the holder includes first clamping section, second clamping section and connects in first clamping section with the bending section between the second clamping section, the holder is in at least the part of bending section has elasticity, the bending section is equipped with hollow out construction, first clamping section with the second clamping section all is including keeping away from the free end of bending section, under natural state, the free end of first clamping section with the free end of second clamping section is drawn close relatively, flexible elongate member part with the holder is connected.

The application further provides an artificial chordae tendineae implantation system, which comprises a pushing catheter, a clamping push rod movably arranged in the pushing catheter in a penetrating mode, a slender control piece and the artificial chordae tendineae, wherein the clamping piece is located between the far end of the clamping push rod and the far end of the pushing catheter, and the slender control piece is movably connected with the clamping piece.

In the artificial chordae tendineae and the artificial chordae tendineae implanting system provided by the application, as the bending section of the clamping piece is provided with the hollowed-out structure, on one hand, the mechanical property of the clamping piece can be improved, and therefore the pulling force required for pulling the first clamping section and the second clamping section apart is reduced; on the other hand, the weight of the clamping piece can be reduced under the condition that the size of the clamping piece is not reduced, meanwhile, the contact area of the clamping piece and the tissue is ensured, and the fatigue resistance of the clamping piece implanted into a human body for a long time is improved.

Drawings

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

Fig. 1 is a schematic structural view of an artificial chordae implantation system according to a first embodiment of the present application.

Figure 2 is a schematic view of the distal and proximal clamps of the artificial chordae implantation system of figure 1 in an open configuration.

Fig. 3 is a schematic view of the holder of fig. 2 in an open state.

Fig. 4 is a schematic perspective view of fig. 3 from another viewing angle.

Fig. 5 is a schematic perspective view of an artificial chordae provided in the first embodiment of the present application.

Fig. 6 is a perspective view of the clamping member of fig. 5.

Fig. 7 is a side view of the clip of fig. 6.

Fig. 8 is a perspective view of the clamping member and flexible elongate member of fig. 5 in another connection.

Fig. 9 is a side view of fig. 8.

Fig. 10 is a perspective view of the clamping member and flexible elongated member of fig. 5 in yet another connection configuration.

Fig. 11 is a side view of fig. 10.

Fig. 12 is a perspective view of the clamp of fig. 6 in an open position.

Figures 13-20 are schematic illustrations of the use of the artificial chordae implantation system provided in the first embodiment of the present application.

Fig. 21 is a schematic perspective view of a clamping member according to a second embodiment of the present application.

Fig. 22 is a perspective view of the clip of fig. 21 from another perspective.

Fig. 23 is a side view of the clip of fig. 22.

Fig. 24 is a perspective view of a clamping member according to a third embodiment of the present application.

Fig. 25 is a side view of the clip of fig. 24.

Fig. 26 is a schematic view of the clamp of fig. 24 in a flattened state.

The following detailed description will further illustrate the present application in conjunction with the above-described figures.

Detailed Description

The technical solutions in the embodiments of the present application will be described clearly and completely with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without inventive step, are within the scope of the present disclosure.

In addition, the following description of the various embodiments refers to the accompanying drawings, which are included to illustrate specific embodiments that can be used to practice the present application. Directional phrases referred to in this application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", and the like, refer to the orientation as shown in the attached drawings only, and thus, are used for better and clearer illustration and understanding of the present application, rather than to indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present application.

It should be noted that, in order to describe the structure of the artificial chordae tendineae and the artificial chordae tendineae implantation system more clearly, the terms "proximal" and "distal" are used herein as terms commonly used in the field of interventional medicine. Specifically, "distal" refers to the end of the surgical procedure that is distal from the operator, and "proximal" refers to the end of the surgical procedure that is proximal to the operator; the direction of a rotating central shaft of an object such as a column body, a pipe body and the like is defined as an axial direction; the circumferential direction is the direction around the axis of an object such as a column, a pipe body and the like (perpendicular to the axis and the radius of the section); radial is the direction along a diameter or radius. It is noted that the term "end" as used herein, whether in the context of "proximal end", "distal end", "one end", "another end", "first end", "second end", "initial end", "terminal end", "two ends", "free end", "upper end", "lower end", and the like, is not limited to a tip, end or end surface, but also includes a portion extending an axial and/or radial distance from the tip, end or end surface over the component to which the tip, end or end surface pertains. 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 application 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 application.

Referring to fig. 1 to 5 together, a first embodiment of the present application provides an artificial chordae implantation system 1 for implanting artificial chordae 70 into a patient to replace diseased or broken chordae in the heart of the patient and thereby pulling on the leaflets during ventricular systole to avoid regurgitation.

Specifically, as shown in fig. 1 to 5, the artificial chordae implantation system 1 comprises a pushing device 10, a holding device 30, an elongated control member 50 and an artificial chordae 70. As shown in fig. 1 and 2, the pushing device 10 includes a pushing catheter 12 having a plurality of through lumens formed in an axial direction. As shown in FIG. 2, the holding device 30 includes a holding pusher 32 threaded into a lumen of the pusher catheter 12, a distal collet 34 disposed at the distal end of the holding pusher 32, and a proximal collet 36 disposed at the distal end of the pusher catheter 12. It will be appreciated that as the clamping pusher 32 moves axially within the pusher catheter 12, the clamping pusher 32 causes the distal collet 34 to open and close relative to the proximal collet 36. It will be appreciated that the artificial chordae implantation system 1 may also be provided without the separate distal and proximal collets 34, 36, with the relative opening and closing between the clamping surface of the clamping push rod 32 (i.e., the end surface of the clamping push rod 32 facing the pusher catheter 12) and the clamping surface of the pusher catheter 12 (i.e., the end surface of the pusher catheter 12 facing the clamping push rod 32) being accomplished directly by axial movement of the clamping push rod 32.

As shown in fig. 2 and 5, the artificial chordae 70 includes a clamp 72 and a flexible elongate member 74 connecting the clamp 72. The flexible elongate member 74 is partially connected to the clamping member 72, the clamping member 72 serving to anchor the part of the flexible elongate member 74 connected thereto to the leaflets. In this embodiment, the gripping member 72 is positioned between the distal collet 34 and the proximal collet 36, and the flexible elongate member 74 is threaded into a lumen of the pusher catheter 12. When the far-end chuck 34 and the near-end chuck 36 are closed, the clamping pieces 72 can be conveniently conveyed to the valve leaflets, and the clamping pieces 72 are not contacted with human tissues in the conveying process, so that scraping is avoided; when the distal and proximal jaws 34, 36 are spread apart, the grasping elements 72 are controlled by the elongate control member 50 to open to grasp the valve leaflets, and after the grasping elements 72 grasp the valve leaflets, the grasping elements 72 are easily released. In other embodiments, flexible elongate member 74 may be received within a lumen that retains push rod 32. It will be appreciated that when the artificial chordae implantation system 1 is not provided with separate distal and proximal collets 34, 36, the clamp 72 is located between the distal end of the clamp push rod 32 and the distal end of the push catheter 12.

As shown in fig. 5, the clamping member 72 includes a first clamping section 721, a second clamping section 722, and a bending section 723 connected between the first clamping section 721 and the second clamping section 722. The clip 72 is resilient at least in the portion of the bend 723. The first clamping section 721 and the second clamping section 722 each include a free end far away from the bending section 723, and in a natural state, the free end of the first clamping section 721 is relatively close to the free end of the second clamping section 722. The first clamping section 721, the bending section 723 and the second clamping section 722 form a leaflet receiving space. Preferably, the clamping member 72 is elastic, and the clamping member 72 is a structure similar to an elastic clip with a certain elastic clamping force.

The end surface of the proximal collet 36 is parallel to the end surface of the distal collet 34 and is inclined distally, with the angle between the two end surfaces and the central axis of the pusher catheter 12 being less than 90 degrees. Therefore, in the clamping element 72 disposed between the distal collet 34 and the proximal collet 36, the first clamping section 721 is adjacent to the distal collet 34, the second clamping section 722 is adjacent to the proximal collet 36, and the free ends of the first clamping section 721 and the second clamping section 722 are both inclined towards the distal end, so that the clamping element 72 can capture and clamp the valve leaflet.

Preferably, in this embodiment, as shown in fig. 3 and 4, the end surface of the proximal collet 36 is provided with a stop structure 362, which includes a pair of spaced apart stops. When clamping member 72 is positioned between distal collet 34 and proximal collet 36, the stop block is a clearance fit with second clamping segment 722. It should be noted that the distance between the pair of limiting blocks of the limiting structure 362 is slightly larger than the maximum width of the second clamping section 722, so that the limiting structure 362 can limit the second clamping section 722 to prevent the clamping element 72 from being separated from between the distal clamping head 34 and the proximal clamping head 36 before clamping the valve leaflet, but will not affect the smooth separation of the clamping element 72 after clamping the valve leaflet. It will be appreciated that when the artificial chordae implantation system 1 is not provided with separate distal and proximal collets 34, 36, the stop structure 362 is provided at the distal face of the pusher catheter 12 (i.e., the end face facing the gripping push rod 32).

Alternatively, the end surface of the distal collet 34 is recessed with a first recess, the end surface of the proximal collet 36 is recessed with a second recess, and the first recess and the second recess form a receiving space for receiving the clamping member 72. The holding member 72 is accommodated between the first recess and the second recess, so that after the distal collet 34 and the proximal collet 36 are closed, there is almost no gap between the distal collet 34 and the proximal collet 36, and a smooth-surfaced whole is formed, which is convenient for pushing and reduces the injury to the wound of the patient. The first clamping section 721 is located in the first groove, and the second clamping section 722 is located in the second groove. The distal collet 34 moving distally away from the proximal collet 36 may cause the first gripping section 721 to disengage the first recess, while the second recess may act as a stop for the second gripping section 722 to prevent the gripping element 72 from disengaging between the distal collet 34 and the proximal collet 36 before gripping the leaflets, but may not interfere with the smooth disengagement of the gripping element 72 after gripping the leaflets. It will be appreciated that when the artificial chordae implantation system 1 is not provided with separate distal and proximal collets 34, 36, a first groove is provided in the proximal face of the holding push rod 32 facing the pusher catheter 12 and a second groove is provided in the distal face of the pusher catheter 12 facing the holding push rod 32.

The elongated control member 50 is movably connected to the gripping member 72 such that the gripping member 72 is operable by the elongated control member 50 to grip the valve leaflets and then to partially secure the flexible elongated member 74 to the ventricular wall or papillary muscle to replace diseased or broken chordae tendineae in the patient's heart. Wherein, as shown in fig. 2 and 4, the elongated control member 50 includes a first control wire 51 and a second control wire 52, the first clamping section 721 is provided with a first control hole 7211, the second clamping section 722 is provided with a second control hole 7222, the first control wire 51 is movably connected with the first control hole 7211, and the second control wire 52 is movably connected with the second control hole 7222. The first control wire 51 may then be threaded through the distal collet 34 or the clamping push rod 32 and into the pusher catheter 12 or the clamping push rod 32, and the second control wire 52 may be threaded through the proximal collet 36 and into the pusher catheter 12 or the clamping push rod 32.

In a first embodiment of the present application, as shown in FIGS. 2, 4 and 5, the first clamping section 721 is provided with two first control holes 7211, and the first control wire 51 is U-shaped to pass through the two first control holes 7211 to connect the first clamping section 721, then pass through the distal collet 34 and thread into a lumen of the pusher catheter 12. The second clamping section 722 is provided with two second control holes 7222, and the second control wire 52 is U-shaped through the two second control holes 7222 to connect the second clamping section 722, then through the proximal collet 36 and into a lumen of the pusher catheter 12. In a natural state, the free end of the first clamping section 721 is close to the free end of the second clamping section 722, the clamping member 72 is closed, and the first clamping section 721 and the second clamping section 722 can be pulled open to open the clamping member 72 by tightening the first control wire 51 and the second control wire 52. Specifically, tensioning the second control wire 52 causes the second clamping section 722 to abut against the end surface of the proximal collet 36, tensioning the first control wire 51 causes the free end of the first clamping section 721 to move away from the free end of the second clamping section 722, the clamping member 72 opens, and the leaflet can enter the leaflet receiving space of the clamping member 72; the first control wire 51 is loosened, and the clamping piece 72 can be restored to the natural state by means of the elasticity of the clamping piece, so that the valve leaflet is clamped. After the clamping piece 72 clamps the valve leaflet, the first control wire 51, the second control wire 52 and the clamping piece 72 are connected in a U shape, so that the valve leaflet is convenient to release. In other embodiments, the first control wire 51 connected to the first clamping section 721 can pass through the distal clamping head 34 and be threaded into the lumen of the clamping rod 32, or pass through the clamping rod 32 and be threaded into a lumen of the pusher catheter 12 or the clamping rod 32; the second control wire 52 connected to the second holding section 722 can pass through the proximal collet 36 and be threaded into the lumen of the holding push rod 32.

It is important to note that, in order to facilitate the pulling apart of the clamping member 72 and to improve the fatigue resistance of the clamping member 72 after long-term implantation into the human body, as shown in fig. 5, the clamping member 72 provided in the present application is provided with a hollowed-out structure 724 at the bending section 723. The hollow structures 724 include holes, slots and/or indentations, that is, the hollow structures 724 may be any one, any two or three of the holes, the slots and the indentations. Because the bending section 723 of the clamping member 72 is provided with the hollowed-out structure 724, on one hand, the mechanical property of the clamping member 72 can be improved, so that the pulling force required for pulling the first clamping section 721 and the second clamping section 722 apart is reduced; on the other hand, the weight of the clamp 72 can be reduced without reducing the size of the clamp 72, and the contact area of the clamp 72 and the tissue can be ensured, thereby improving the fatigue resistance of the clamp 72 implanted into the human body for a long time.

The situation that the clamping piece 72 needs to be opened and closed repeatedly to capture the valve leaflets for many times often occurs in the operation process, and if the rebound stress of the clamping piece 72 is too large, the requirement on the pulling force of the first control wire 51 and the second control wire 52 is higher, so that the risk of breakage of the first control wire 51 and the second control wire 52 is increased. According to the application, the hollowed-out structure 724 is additionally arranged on the bending section 723 of the clamping piece 72, the pulling force required for pulling the clamping piece 72 open is small, and the risk of wire breakage is low. The cut-outs 724 act as localized material cuts that reduce the spring-back stress of the clamp 72, which can reduce the pulling force required to control the opening and closing of the clamp 72, improving spring-back performance, and thereby providing the desired elasticity, fatigue resistance, and/or flexibility.

To ensure implant safety, clamping member 72 and flexible elongate member 74 are each formed of a material having good biocompatibility. The holding member 72 may be made of nitinol, cobalt-chromium alloy, stainless steel with certain elasticity, or polymer material with good elasticity, preferably shape memory alloy such as nitinol. The flexible elongate member 74 includes, but is not limited to, a wire, thread, cord, strip, tape, etc., preferably a PTFE or PET medical suture.

Referring to fig. 6 and 7, the bending portion 723 includes a plane and two curved surfaces respectively connecting two opposite ends of the plane, and the two curved surfaces respectively connect the first clamping portion 721 and the second clamping portion 722. Of course, the bending section 723 may also be an arc surface, and two opposite ends of the arc surface connect the first clamping section 721 and the second clamping section 722.

As shown in fig. 6, in the first embodiment of the present application, two opposite ends of the hollow structure 724 respectively extend to the first clamping section 721 and the second clamping section 722, and specifically, the hollow structure 724 is a hole disposed in the middle of the bending section 723, so as to reduce the resilient stress in the middle of the bending section 723, improve the resilience of the bending section 723, and prevent the material from generating plastic deformation and failing to maintain the elastic performance.

Preferably, the bending section 723 includes a pair of connection ends connected to the first clamping section 721 and the second clamping section 722, respectively, and a pair of first sides 7231 connecting the connection ends. The hollowed-out structure 724 is a groove or a notch arranged on at least one first side 7231, so that the resilience stress of the bending section 723 in an open state is further reduced, the stress condition of the bending section 723 can be improved, the bending section 723 is prevented from being broken in a shaping process and a using process, and the stability and the safety of the clamping piece 72 are ensured.

Referring to fig. 5 and 6, the holding member 72 further defines a connecting hole 725, and the flexible elongated member 74 is connected to the holding member 72 through the connecting hole 725. In the first embodiment of the present application, the connection holes 725 open in the plane of the bending section 723, and preferably the number of the connection holes 725 is two. In one embodiment, as shown in fig. 5, a flexible elongated member 74 is U-shaped and is movable through two connecting holes 725 to connect the clamping members 72, the connection being easy. After the gripping members 72 grip the leaflets, the free ends of the flexible elongate member 74 may be secured to the ventricular wall or papillary muscles. It will be appreciated that a single flexible elongate member 74, folded in half in the form of a U, acts as two artificial chordae tendineae and provides improved traction against the leaflets and thus better helps to alleviate regurgitation.

Referring to fig. 8 and 9, the flexible elongate member 74 is provided with a flexible sheath 76 at the portion where it contacts the clamping member 72, the flexible sheath 76 isolating the flexible elongate member 74 from the clamping member 72 without contact wear, thereby preventing the flexible elongate member 74 from breaking due to wear. The flexible sheath 76 may be made of a soft polymer material such as a silicone tube or a PTFE tube, or may be a metal tube with soft hardness such as a pure titanium tube, and the inner cavity and the end surface of the metal tube need to be smooth.

In other embodiments, there may be two flexible elongate members 74, and each flexible elongate member 74 may be associated with an aperture 725 of the holding member 72 to also enhance the pulling action on the leaflets. Referring to fig. 10 and 11, two connection holes 725 of the holding member 72 are opened at a portion of the second holding section 722 close to the bending section 723, and the two flexible elongated members 74 are connected to a corresponding connection hole 725 through a connection sleeve 78 respectively. One end of the connection sleeve 78 is provided with an inner hole for receiving the flexible elongated member 74, one end of the flexible elongated member 74 is fixed in the inner hole of the connection sleeve 78 by crimping or bonding, and the other end of the connection sleeve 78 is provided with a boss structure for preventing the connection sleeve 78 from coming out of the connection hole 725. The connecting sleeve 78 may be made of metal material such as stainless steel, pure titanium, etc., or polymer material such as PEEK, PTFE, etc. Of course, the flexible elongated members 74 may be directly connected to the corresponding connecting holes 725 by knotting or crimping, as long as the diameter of the knotted or crimped end of one end of the flexible elongated member 74 is larger than the diameter of the connecting hole 725, which is not limited. Clamping member 72 may be provided with only one coupling hole 725 for coupling to one or more flexible elongate members 74.

Referring to fig. 5 and 7 again, in the first embodiment of the present application, the free ends of the first clamping section 721 and the second clamping section 722 are extended outward, so as to prevent the free ends of the first clamping section 721 and the second clamping section 722 from generating stress concentration on the leaflets after the clamping elements 72 clamp the leaflets, thereby preventing perforation of the leaflets. Correspondingly, referring again to fig. 2, the end surface of the proximal clamp 36 is recessed with a receiving slot 364 for receiving the outwardly extending free end of the second clamping section 722 to reduce the gap between the distal clamp 34 and the proximal clamp 36 after the two are closed. In other embodiments, the free end of the first clamping section 721 or the free end of the second clamping section 722 extends everted.

Referring to fig. 7, 10 and 12, in the first embodiment of the present application, the first clamping section 721 has a barb 727 at a side facing the leaflet receiving space, and the barb 727 extends obliquely toward the bending section 723 and the leaflet receiving space. Through setting up barb 727, can realize that holder 72 catches fast to leaflet, improve operation efficiency, can also prevent the slippage, guarantee holder 72 anchored stability. It should be noted that the barbs 727 are embedded in the surface of the leaflets and do not need to penetrate the leaflets, thereby reducing damage to the leaflets and preventing tearing. In other embodiments, the barbs 727 may also be disposed on the side of the second clamping section 722 facing the leaflet receiving space, which may achieve the same effect.

Preferably, the first holding section 721 or the second holding section 722 is provided with a crack-stopping groove 728 (see fig. 10) at the root of the barb 727, and by providing the crack-stopping groove 728 at the root of the barb 727, it is possible to prevent the barb 727 from being easily torn off from the first holding section 721 or the second holding section 722 due to pulsation of the leaflet. The crack stopper 728 may be, but is not limited to, a circular through groove, a rectangular through groove, or an oval through groove.

Referring to fig. 6 and 7 again, in order to make the clamping member 72 have a better clamping effect on the valve leaflet, in the embodiment, the clamping thickness H of the valve leaflet receiving space of the clamping member 72 is 0.5-3mm, and/or the clamping width W of the valve leaflet receiving space is 3-8mm, preferably 4-6mm, and/or the clamping depth L of the valve leaflet receiving space is 2-6mm. The clamping thickness H refers to a dimension from a connection point of the first clamping section 721 and the bending section 723 to a connection point of the second clamping section 722 and the bending section 723, the clamping width W refers to a dimension of the bending section 723 extending along a bending axis thereof, and the clamping depth L refers to a dimension from a free end of the first clamping section 721 or a free end of the second clamping section 722 to the bending section 723.

The clamping thickness H of the valve leaflet containing space is set within a reasonable range of 0.5-3mm according to the anatomical structure of the valve leaflets, so that complications such as endocarditis caused by clamping the valve leaflets due to over-small clamping thickness H can be avoided, and the clamping piece 72 can be prevented from falling off due to the fact that the valve leaflets cannot be effectively clamped due to over-large clamping thickness H; the clamping width W of the valve leaflet containing space is set within a reasonable range of 3-8mm, so that the valve leaflets can be prevented from being torn or falling off due to the fact that the clamping width W is too small, and the coaptation effect when the valve leaflets are closed is prevented from being influenced by the fact that the clamping width W is too large; the clamping depth L of the valve leaflet containing space is set within a reasonable range of 2-6mm, so that the clamping piece 72 can be prevented from falling off due to the excessively small clamping depth L, and the closing effect of the valve leaflets during closing can be prevented from being influenced by the excessively large clamping depth L.

The hollow-out structures 724 also function to adjust an appropriate clamping force without damaging the leaflets by exerting a large clamping force on the leaflets, while ensuring the clamping width W of the leaflet housing space. Therefore, the clamping force of the clamping member 72 can be adjusted by adjusting the size of the hollow-out structures 724. Preferably, as shown in fig. 6, in addition to the bending section 723 being provided with the hollowed-out structure 724, the first clamping section 721 and/or the second clamping section 722 may also be provided with a fabrication hole or the like, so as to further reduce the weight of the clamping member 72. Furthermore, the hollow structure 724 formed on the holding member 72 can accelerate the covering of the cells. In addition, the outer surface can also be wrapped up with the tectorial membrane in the holder 72, can prevent holder 72's sharp limit and valve leaflet contact, reduces the damage to the valve leaflet, also is favorable to the cell to climb and cover.

Referring again to fig. 1, in the present embodiment, to facilitate the manipulation of the artificial chorda 70 during implantation, the pushing device 10 further includes a handle 14 connected to the proximal end of the pushing catheter 12, the handle 14 being provided with an operating member 142 for operating the clamping push rod 32, the flexible elongate member 74, the first control wire 51 and the second control wire 52.

Specifically, as shown in FIG. 1, the handle 14 includes a housing 144 coupled to the proximal end of the pusher catheter 12, and the operating member 142 includes a first operating button 1421, a second operating button 1422, a third operating button 1423, and a fourth operating button 1424 disposed on the housing 144. The housing 144 has a sliding groove corresponding to each operating button, each sliding groove extends along the axial direction of the pushing catheter 12, and each sliding groove has a proximal stopping groove and a distal stopping groove at two opposite ends in the extending direction, and each stopping groove communicates with the corresponding sliding groove and extends in the direction perpendicular to the sliding groove.

In the embodiment of the present application, the proximal end of the holding push rod 32, the proximal end of the first control wire 51, the proximal end of the second control wire 52 and the proximal end of the flexible elongate member 74 are respectively connected to the first operation button 1421, the second operation button 1422, the third operation button 1423 and the fourth operation button 1424. It will be appreciated that by controlling the movement of the first operating button 1421 within the corresponding sliding slot, the axial movement of the clamping bar 32 along the pusher catheter 12 can be controlled, thereby moving the distal clamping head 34 to open and close relative to the proximal clamping head 36. By controlling the second operation button 1422 and the third operation button 1423 to move in the corresponding sliding slots, the first control wire 51 and the second control wire 52 can be tightened or loosened, and the free end of the first clamping section 721 and the free end of the second clamping section 722 are controlled to be relatively far away or close, so that the clamping member 72 is opened or closed. Similarly, the flexible elongate member 74 can be tightened or loosened by controlling the fourth operating button 1424 to move within the corresponding sliding channel, thereby tightening the flexible elongate member 74 before the clamping member 72 clamps the leaflets and loosening the flexible elongate member 74 after the clamping member 72 clamps the leaflets.

It will also be appreciated that when any one of the operating buttons is located in either one of the stopping grooves at opposite ends of the corresponding sliding groove, the axial movement of the operating button is limited, and thus the axial movement or slack of the clamping push rod 32, the first control wire 51, the second control wire 52 or the flexible elongate member 74 correspondingly coupled to the operating button is locked. For example, when the fourth operating button 1424 is positioned within the proximal stop channel, the flexible elongate member 74 is under tension in the pusher catheter 12 and is not tedious; when the fourth operating button 1424 is moved distally within its corresponding sliding channel, the flexible elongate member 74 is in a relaxed state.

The use of the artificial chordae implantation system 1 of the first embodiment will now be described with reference to figures 1 to 3 and 13 to 20, taking the example of transapical implantation of an artificial chordae 70.

The first step is as follows: as shown in fig. 13, the artificial chordae implant system 1 is advanced transapically into the left ventricle and the artificial chordae implant system 1 is advanced until both the distal clip 34 and the proximal clip 36 are in the left atrium.

The second step: as shown in fig. 2 and 14, the first operating button 1421 is moved distally to push the clamping push rod 32 distally so that the distal collet 34 and the proximal collet 36 are spread apart, and the clamping member 72 of the artificial tendon implant system 1 is exposed, and the third operating button 1423 is moved proximally to pull the second control wire 52 so that the second clamping section 722 of the clamping member 72 abuts against the proximal collet 36.

The third step: as shown in fig. 3 and 15, moving the second operating button 1422 proximally tensions the first control wire 51, causing the first control wire 51 to move the first clamping section 721 open relative to the second clamping section 722 to facilitate the leaflet entering the leaflet receiving space.

The fourth step: as shown in fig. 16 and 17, the distal end of the artificial chordae implantation system 1 is moved slightly until the leaflet edge contacts the inner wall of the holder 72.

The fifth step: as shown in fig. 18 and 19, the second operation button 1422 is moved distally to release the pulling force of the first control wire 51 on the first clamping section 721, so that the first clamping section 721 is closed relative to the second clamping section 722, the leaflet is clamped by the clamping element 72, the first clamping section 721 fits the atrial side surface of the leaflet, and the second clamping section 722 fits the ventricular side surface of the leaflet.

Wherein the flexible elongate member 74 can be prevented from being overly tedious by moving the fourth operating button 1424 proximally to tighten the flexible elongate member 74 during the first through fifth steps.

And a sixth step: disconnecting the first control wire 51 from the second operating button 1422 and disconnecting the second control wire 52 from the third operating button 1423, respectively, withdrawing the first control wire 51 from the second control wire 52, disengaging the retaining member 72 anchored to the leaflet from between the distal collet 34 and the proximal collet 36, and disconnecting the flexible elongate member 74 from the fourth operating button 1424;

the seventh step: the handle 14 is withdrawn to withdraw the push catheter 12 from the heart until the flexible elongate member 74 is released from the lumen of the push catheter 12 and the length of the flexible elongate member 74 remaining in the heart is adjusted to secure its end remote from the holding member 72 to the ventricular wall by the locking pin 90 (as shown in figure 20) to complete implantation of the artificial chordae 70. Of course, the end of the flexible elongate member 74 remote from the clamping member 72 may also be secured to the ventricular wall or papillary muscle by a knot.

Referring to fig. 21 to 23 together, the artificial chordae tendineae implantation system according to the second embodiment of the present application has a similar structure to the artificial chordae tendineae implantation system 1 of the first embodiment, except that: in the second embodiment, the first holding section 721 and the second holding section 722 of the holding member 72b are each provided with barbs 727, which further improves the catching force of the holding member 72b and prevents the leaflets from slipping off. Wherein the barbs 727 on the first clamping section 721 and the barbs 727 on the second clamping section 722 are offset from each other. The first holding section 721 and the second holding section 722 are provided with a crack stop groove 728 at the root of the barb 727.

Further, as shown in fig. 21 to 23, the first clamping section 721 includes a pair of second side edges 7212 connected to opposite sides of a free end thereof, respectively, the second clamping section 722 includes a pair of third side edges 7223 connected to opposite sides of a free end thereof, respectively, and at least one of the second side edges 7212 and/or at least one of the third side edges 7223 extends everted. Preferably, in the second embodiment, each of the second side edges 7212 of the first clamping section 721 and each of the third side edges 7223 of the second clamping section 722 are extended in eversion. The sides of the first and second clamping sections 721, 722 also extend outward, making the clamp 72b less prone to damage to the leaflets, further improving their fatigue resistance.

Referring to fig. 24 to 26 together, the third embodiment of the present application provides an artificial chordae implantation system having a similar structure to the artificial chordae implantation system 1 of the first embodiment, except that: in the third embodiment, the barbs 727 are disposed at the side of the first holding section 721 and/or the second holding section 722, so as to improve the distribution of the barbs 727 in the width direction of the holding member 72c (i.e. the direction parallel to the bending axis of the bending section 723), and improve the anchoring effect of the holding member 72 c.

Specifically, as shown in fig. 24 and 25, the first clamping section 721 includes a pair of second side edges 7212 respectively connected to opposite sides of the free end thereof, the second clamping section 722 includes a pair of third side edges 7223 respectively connected to opposite sides of the free end thereof, and at least one of the second side edges 7212 and/or at least one of the third side edges 7223 is provided with barbs 727. Preferably, in the third embodiment, each second side 7212 of the first holding section 721 and each third side 7223 of the second holding section 722 are provided with barbs 727, and the barbs 727 of the first holding section 721 and the barbs 727 of the second holding section 722 are staggered.

It will be appreciated that, in the case of the same width, the barbs 727 are provided on both sides of the holding member 72c, which corresponds to increasing the distance of the barbs 727 in the width direction, thereby increasing the region where the barbs 727 are anchored, i.e., dispersing the anchoring force of the barbs 727 over a wider area of the leaflet being pinched, preventing damage to the leaflet due to too concentrated barbs 727, such as causing inflammatory reaction or perforation of the leaflet, etc.

Further, in the third embodiment, as shown in fig. 26, the hollowed-out structures 724 on the clamping member 72c are holes disposed in the middle of the bending section 723, two opposite ends of the holes respectively extend to the first clamping section 721 and the second clamping section 722, and the middle of the hole is wide and two ends of the hole are narrow, so that the mechanical property of the clamping member 72c can be improved. Specifically, when the clamping member 72 is opened, the deformation amount of the middle position of the bending section 723 is large, the maximum width of the hole is just located at the position with the large deformation amount, the fatigue strain generated during opening can be relieved, the fatigue resistance performance is improved, and the damage effect of the stress on the two ends of the hole can be relieved in a transition mode due to the fact that the two ends of the hole are narrow, and cracks are prevented from being generated.

The foregoing is an implementation of the embodiments of the present application, and it should be noted that, for those skilled in the art, several modifications and decorations can be made without departing from the principle of the embodiments of the present application, and these modifications and decorations are also regarded as the protection scope of the present application.

Claims (17)

1. The utility model provides an artificial chordae tendineae, its characterized in that includes holder and flexible elongated member, the holder includes first clamping section, second clamping section and connects in first clamping section with the bending section between the second clamping section, the holder is at least the part of bending section has elasticity, the bending section is equipped with hollow out construction, first clamping section with second clamping section all is including keeping away from the free end of bending section, under natural state, the free end of first clamping section with the free end of second clamping section is drawn close relatively, flexible elongated member part with the holder is connected.

2. The artificial chordae tendineae of claim 1, wherein opposing ends of the openwork extend to the first clamping segment and the second clamping segment, respectively.

3. The artificial chordae tendineae of claim 1 or 2, wherein the bending section comprises a pair of connecting ends connected to the first clamping section and the second clamping section, respectively, and a pair of first sides connecting the connecting ends, and the hollow structure is a groove or a notch opened on at least one of the first sides.

4. The artificial tendon of claim 1 wherein the bend segment comprises a planar surface and two curved surfaces connecting opposite ends of the planar surface, the two curved surfaces connecting the first clamping segment and the second clamping segment, respectively.

5. The artificial chordae of claim 1, wherein the free end of the first clamp segment and/or the free end of the second clamp segment extends everted.

6. The artificial tendon of claim 1 or 5 wherein the first clamping segment includes a pair of second sides connected to opposite sides of its free end, respectively, and the second clamping segment includes a pair of third sides connected to opposite sides of its free end, respectively, at least one of the second sides and/or at least one of the third sides extending everted.

7. The artificial chordae of claim 1, wherein the first clamping section and/or the second clamping section is provided with barbs extending obliquely towards the bend section.

8. The artificial chordae tendineae of claim 7, wherein the first clamping section comprises a pair of second sides connected to opposite sides of the free end of the first clamping section, and the second clamping section comprises a pair of third sides connected to opposite sides of the free end of the second clamping section, at least one of the second sides and/or at least one of the third sides being provided with the barbs.

9. The artificial chordae of claim 7, wherein the first clamping section and/or the second clamping section is provided with a crack stop groove at the root of the barb.

10. The artificial chordae tendineae of claim 1, wherein the clamping member defines a coupling hole through which the flexible elongate member is coupled to the clamping member, and a sheath is disposed over a portion of the flexible elongate member in contact with the clamping member.

11. The artificial chordae tendineae of claim 1, wherein the first clamping section, the bend section, and the second clamping section form a leaflet receiving space having a pinch thickness of 0.5-3mm; and/or

The clamping width of the valve leaf accommodating space is 3-8mm; and/or

The clamping depth of the leaflet receiving space is 2-6mm.

12. An artificial chordae implantation system comprising a push catheter, a clamping push rod movably threaded in the push catheter, an elongated control member, and an artificial chordae according to any of claims 1-11, the clamping member being located between the distal end of the clamping push rod and the distal end of the push catheter, the elongated control member being movably connected to the clamping member.

13. The artificial chordae implantation system of claim 12, wherein the elongated control element comprises a first control wire and a second control wire, the first clamping section having a first control hole and the second clamping section having a second control hole, the first control wire being movably coupled to the first control hole and the second control wire being movably coupled to the second control hole.

14. The artificial chordae implantation system of claim 13, further comprising a handle connected to the proximal end of the push catheter, the handle having an operating member for operating the clamping push rod, the flexible elongate member, the first control wire, and the second control wire.

15. The artificial chord implantation system according to claim 12, further comprising a distal collet and a proximal collet that are relatively openable and closable, the distal collet being disposed at a distal end of the clamping push rod and the proximal collet being disposed at a distal end of the pusher catheter, the clamp being positioned between the distal collet and the proximal collet.

16. The artificial chordae implantation system of claim 15, wherein the end face of the proximal collet defines a stop structure comprising a pair of spaced apart stops that are in clearance fit with the second clamping section.

17. The artificial chordae implantation system of claim 15, wherein an end surface of the distal collet defines a first recess and an end surface of the proximal collet defines a second recess, the holder being received between the first and second recesses.

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