Transcatheter suture implantation device and transcatheter tendon chord implantation system

Abstract

The present invention provides a transcatheter suture implantation device, comprising a chuck assembly that can open and close relatively, a sheath connected to the proximal end of the chuck assembly, a puncture assembly disposed in the chuck assembly, a group of implantation wires and a group of pulling wires, the puncture assembly comprising a puncture piece slidably disposed in the chuck assembly and a puncture connector corresponding to the puncture piece, a group of implantation wires folded in half and disposed in the inner cavity of the sheath, the two ends of the implantation wires are respectively connected to two of the puncture connectors, the pulling wire comprises a curved portion pre-installed in the chuck assembly and bypassing the two puncture connectors, the puncture piece is connected to the puncture connector, and drives the puncture connector and the implantation wire into the curved portion of the pulling wire, the pulling wire is withdrawn to drive the implantation wire into the sheath until the implantation wire is pulled out of the sheath. The present invention also relates to a transcatheter tendon chord implantation system.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a transcatheter suture implantation device and a transcatheter tendon chord implantation system. Background Art

[0002] The mitral valve is a one-way valve between the left atrium and ventricle, which ensures blood flows from the left atrium to the left ventricle. Figure 1 As shown, a normal healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, and prevent the blood from flowing from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to the papillary muscle of the left ventricle 3 by chordae tendineae 4. Under normal circumstances, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Figure 2 As shown, when the leaflets of the mitral valve 1 or its related structures undergo organic or functional changes, such as partial rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 will not fit properly. As a result, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] Currently, chordalopathy can be treated by surgically implanting sutures as artificial chordae, but this requires invasive thoracotomy technology and general anesthesia with moderate hypothermia and extracorporeal circulation as auxiliary support. The surgical procedure is complicated and costly, and the patient suffers from high degree of trauma, high risk of complications, long hospitalization, and a painful recovery process.

[0004] Another treatment method is to implant artificial tendons through minimally invasive methods. For example, a shorter thick straight tube is used as a delivery device for the implant and puncture assembly. After being directly inserted into the patient's heart through the transapical route, a suture with anti-slip parts is implanted on the surface of the mitral valve leaflet. The two ends of the suture are fixed at the apex of the heart as artificial tendons to maintain the tension of the ventricular wall on the valve leaflet. However, the defect of this treatment method is that it requires transapical approach, which causes great damage to the human body and has high surgical risks. Moreover, this implant delivery device cannot be used for remote intervention. The analysis is as follows: the transapical path is short. In order to ensure the reliability of puncturing the valve leaflets, the puncture components are mostly made of rigid materials and structures. When remote intervention is adopted, in order to ensure that the anti-slip parts are implanted on the left atrial side, the surgical path needs to pass through the aortic arch-aortic valve-left ventricle-left atrium. The surgical path is relatively tortuous, requiring the implant delivery device to have good flexibility, and the rigid puncture component is difficult to pass through the complex vascular path. If the rigid puncture component is changed to a flexible material and structure, under such a tortuous surgical path, when the puncture is performed by pushing the puncture component on the handle, the flexibility of the material will cause a loss of puncture force, increase the difficulty of puncture, and reduce the effectiveness of puncture. The surgical risk is high and the effectiveness of the device is poor. Summary of the invention

[0005] The technical problem to be solved by the present invention is that, in view of the defects of the prior art, a transcatheter suture implantation device and a transcatheter chord implantation system are provided, which implant at least one set of sutures as artificial chords into the leaflets of the mitral valve in a minimally invasive manner, and then fix the ends of the sutures to the ventricular wall, papillary muscle or apex of the heart, thereby replacing natural chords with sutures.

[0006] In order to solve the above technical problems, the present invention provides a transcatheter suture implantation device, comprising a clamp assembly that can be opened and closed relatively, a bendable sheath connected to the proximal end of the clamp assembly, a puncture assembly arranged in the clamp assembly, a group of implantation lines and a group of pulling lines, the puncture assembly comprises a puncture piece slidably arranged on the clamp assembly and a puncture connector corresponding to the puncture piece, after a group of implantation lines are folded in half, the two ends of the implantation lines are respectively connected to the two puncture connectors; the clamp assembly comprises a proximal clamp and a distal clamp that can be opened and closed relatively, the implantation line and the puncture connector The connecting piece is arranged on the proximal clamp, the puncture piece is arranged on the distal clamp, the pulling wire includes a curved portion pre-installed in the distal clamp and bypassing the outer sides of the two puncture pieces, and the proximal end of the pulling wire passes through the proximal end of the sheath; the puncture piece can be driven to extend out of the distal clamp and connect with the puncture connecting piece, and also drive the puncture connecting piece and the implanting wire to withdraw to the distal clamp so that the implanting wire enters the curved portion of the pulling wire, and the pulling wire withdraws to drive the implanting wire into the sheath until the implanting wire is pulled out of the sheath.

[0007] The present invention also provides a transcatheter chord implantation system, comprising a transcatheter suture implantation device and a guide device, wherein the transcatheter suture implantation device is movably installed in the guide device, wherein the guide device comprises an adjustable bend tube and a bend adjustment mechanism disposed at the proximal end of the adjustable bend tube, wherein the clamp assembly extends from the distal end of the adjustable bend tube, wherein the distal end of the adjustable bend tube is provided with at least one adjustable bend segment, wherein the bend adjustment mechanism comprises a bend adjustment piece disposed at the proximal end of the adjustable bend tube and an adjustment wire connected to the bend adjustment piece, wherein the distal end of the adjustment wire is connected to the adjustable bend segment, and the bend adjustment piece pulls the adjustment wire to bend the adjustable bend segment so as to adjust the distal position of the transcatheter suture implantation device.

[0008] The sheath bending adjustment mechanism of the transcatheter chord implantation system provided by the present invention can be used to adjust the adjustable bending section of the sheath to a bending state, so that the sheath adapts to the requirements of the curved human body lumen structure and is suitable for remote intervention; a group of implantation wires and a group of pulling wires are arranged in the clamp assembly and the sheath of the transcatheter suture implantation device, which are connected to the puncture connector after puncturing the valve leaflet through the puncture member, and the withdrawal of the puncture member can drive the puncture connector and the implantation wire to pass through the valve leaflet; the implantation wire can be pulled out of the sheath through the movement of the pulling wire, and the operator can cut the implantation wire according to needs and fix the implantation wire on the ventricular wall or papillary muscle. It is easy to use, simple to operate, less harmful to the human body, and has reduced surgical risks. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation are briefly introduced below.

[0010] Figure 1 This is a schematic diagram of the mitral valve in its normal state.

[0011] Figure 2 This is a schematic diagram of a mitral valve disease.

[0012] Figure 3 1 is a schematic structural diagram of a transcatheter tendon chord implantation system according to a first embodiment of the present invention.

[0013] Figure 4 It is a schematic diagram of the three-dimensional structure of the transcatheter suture implantation device of the transcatheter chord implantation system of the first embodiment of the present invention.

[0014] Figure 5 yes Figure 4 Schematic diagram of the three-dimensional structure of the clamp assembly of the transcatheter suture implantation device.

[0015] Figure 6 yes Figure 4 A schematic diagram of the three-dimensional structure of the chuck assembly from another perspective.

[0016] Figure 7It is a schematic structural diagram of an implantation wire, an anti-slip member and a puncture connection member of a transcatheter suture implantation device according to a first embodiment of the present invention.

[0017] Figure 8 yes Figure 7 Schematic diagram of the structure of the implant wire, anti-slip part and puncture connector from another perspective.

[0018] Fig. 9 It is a schematic diagram of the cooperation between the puncture member and the puncture connector of the transcatheter suture implantation device of the first embodiment of the present invention.

[0019] Fig.10 yes Figure 4 A cross-sectional view of the connector of the transcatheter suture implantation device.

[0020] Fig.11 FIG. 4 is a cross-sectional view of a probe of the transcatheter suture implantation device according to the first embodiment of the present invention.

[0021] Fig.12 yes Figure 4 Schematic diagram of the three-dimensional structure of the proximal clamp of the transcatheter suture implantation device.

[0022] Fig.13 yes Fig.12 Side view of the proximal clamp in FIG.

[0023] Fig.14 yes Fig.12 A cross-sectional view of the proximal chuck along line XIV-XIV.

[0024] Fig.15 yes Figure 4 A three-dimensional structural diagram of the distal clamp of the transcatheter suture implantation device.

[0025] Fig.16 yes Fig.15 Side view of the distal clamp in FIG.

[0026] Fig.17 yes Fig.16 A cross-sectional view of the distal chuck along line XVII-XVII.

[0027] Fig.18 yes Fig.15 A cross-sectional view of the distal chuck along line XVIII-XVIII.

[0028] Fig.19 It is a cross-sectional view of the proximal clamp and the distal clamp of the transcatheter suture implantation device according to the first embodiment of the present invention after being connected.

[0029] Fig. 20 It is a structural schematic diagram of one implementation manner of the connecting rod of the transcatheter suture implantation device of the first embodiment of the present invention.

[0030] Fig.21 It is a structural schematic diagram of one implementation manner of the connecting rod of the transcatheter suture implantation device of the first embodiment of the present invention.

[0031] Fig. 22 It is a structural schematic diagram of one implementation manner of the connecting rod of the transcatheter suture implantation device of the first embodiment of the present invention.

[0032] Fig.23 1 is a schematic structural diagram of another implementation manner of the connecting rod of the transcatheter suture implantation device of the first embodiment of the present invention.

[0033] Fig.24 1 is a schematic structural diagram of a control handle of a transcatheter suture implantation device according to a first embodiment of the present invention.

[0034] Fig.25 yes Fig.24 A schematic diagram of the structure of the control handle from another perspective.

[0035] Fig.26 It is a schematic structural diagram of the guiding device of the transcatheter chord implantation system of the first embodiment of the present invention.

[0036] Fig. 27 yes Fig.26 A partial cross-sectional view of the guide device in FIG.

[0037] Fig.28 yes Figure 1 Schematic diagram of the structure of the initial state of the transcatheter chordal implantation system.

[0038] Fig.29 yes Fig.28 A cross-sectional view of a clamp assembly of a transcatheter suture implantation device of a transcatheter chord implantation system.

[0039] Fig.30 yes Fig.28 Schematic diagram of the structure of the clamp assembly of the transcatheter suture implantation device of the transcatheter chord implantation system in the open state.

[0040] Fig.31 yes Fig.30 Cross-sectional view of the chuck assembly in the open state.

[0041] Fig.32 yes Fig.30 Schematic diagram of the structure after the clamp assembly is opened and the leaflet is placed.

[0042] Fig.33 yes Fig.32 Schematic diagram of the structure of the clamp assembly clamping the leaflet.

[0043] Fig.34 yes Fig.33 Schematic diagram of the structure in which the clamp assembly clamps the valve leaflet and the puncture assembly punctures the valve leaflet.

[0044] Fig.35 yes Fig.34 An enlarged view of section XXXV.

[0045] Fig.36 yes Fig.34 Schematic diagram of the structure in which the puncture assembly is combined with the sleeve and withdrawn.

[0046] Fig.37 yes Fig.36 Schematic diagram of the structure of the pull wire pulling back the implant wire.

[0047] Figures 38 to 50 is a schematic diagram of the use process of the transcatheter tendon chord implantation system provided by the present invention; wherein, Fig.39 yes Fig.38 An enlarged view of part XXXIX; Fig.41 yes Fig.40 Enlarged view of section XLI; Fig.50 yes Fig.49 Enlarged view of the L part.

[0048] Fig.51 It is a schematic structural diagram of a clamp assembly of a transcatheter chord implantation system according to a second embodiment of the present invention.

[0049] Fig.52 yes Fig.51 A partial cross-sectional view of a chuck assembly.

[0050] Fig.53 It is a schematic cross-sectional structural diagram of a clamp assembly of a transcatheter chord implantation system according to a third embodiment of the present invention.

[0051] Fig.54 It is a schematic structural diagram of the clamp assembly of the transcatheter chord implantation system of the fourth embodiment of the present invention.

[0052] Fig.55 4 is a side view of a clamp assembly of a transcatheter chord implantation system according to a fifth embodiment of the present invention.

[0053] Fig.56 yes Fig.55 End view of the chuck assembly in.

[0054] Fig.57 It is a schematic structural diagram of the implantation wire and sleeve of the transcatheter chord implantation system of the sixth embodiment of the present invention.

[0055] Fig.58 yes Fig.57 A schematic structural diagram of another view of the implant wire and sleeve.

[0056] Fig.59 It is a schematic structural diagram of the implantation wire and the pulling wire of the transcatheter tendon chord implantation system of the seventh embodiment of the present invention. DETAILED DESCRIPTION

[0057] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0058] In addition, the following descriptions of the embodiments are made with reference to the attached diagrams to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached diagrams. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0059] In order to more clearly describe the structure of the transcatheter suture implantation device and the transcatheter chord implantation system, the limiting terms "proximal end" and "distal end" described in the present invention are commonly used terms in the field of interventional medicine. Specifically, the "distal end" refers to the end away from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by technicians in the technical field of the present invention. The common terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not to be construed as limitations on the present invention.

[0060] See also Figures 2 to 6 The present invention provides a transcatheter tendon chord implantation system 100, which includes a transcatheter suture implantation device 20 and a guide device 60 for implanting sutures into valve leaflets; the guide device 60 includes an adjustable curved tube 61 and a curved adjustment mechanism 62 disposed at the proximal end of the adjustable curved tube. The transcatheter suture implantation device 20 is installed in the guide device 60, and the transcatheter suture implantation device 20 is sent to a predetermined position by adjusting the direction of the adjustable curved tube 61.

[0061] The transcatheter suture implantation device 20 includes a control handle 21, a clamp assembly 22 that can be opened and closed relative to each other, a bendable sheath tube 24 connected to the proximal end of the clamp assembly 22, a puncture assembly 25 disposed in the clamp assembly 22, a set of implantation wires 271 and a set of pull wires 275; the puncture assembly 25 includes a puncture member 251 slidably disposed in the clamp assembly 22 and a puncture connector 254 corresponding to the puncture member 251; a set of implantation wires 271 is folded in half and disposed in the inner cavity of the sheath tube 24 The two ends of the implantation wire 271 are respectively connected to two puncture connectors 254, and the pulling wire 275 includes a curved portion 2750 pre-installed in the clamp assembly 22 and bypassing the two puncture connectors 254; after the puncture member 251 is connected to the puncture connector 254, the puncture connector 254 and the implantation wire 271 are driven into the curved portion 2750 of the pulling wire 275, and the pulling wire 275 is withdrawn to drive the implantation wire 271 into the sheath 24 until the implantation wire 271 is pulled out of the sheath 24. In this embodiment, after the operator inserts the guide device 60 and the distal end of the transcatheter suture implantation device 20 into the patient's body by intervention, the operator adjusts the clamp assembly 22 of the transcatheter suture implantation device 20 to a predetermined treatment position through the guide device 60 outside the patient's body; the clamp assembly 22 is then controlled by the control handle 21 of the transcatheter suture implantation device 20 to clamp the valve leaflet, and the puncture member 251 is controlled to puncture the valve leaflet and connect with the corresponding puncture connector 254, and the puncture member 251 is withdrawn to drive the puncture connector 254 and the implantation line 271 to pass through leaflet; pull the pulling wire 27 proximally so that the curved portion 2750 of the pulling wire 275 drives the implanting wire 271 after passing through the leaflet to enter the sheath 24, until the folded portion of the implanting wire 271 is attached to the surface of the leaflet, thereby implanting the implanting wire 271 on the leaflet of the valve; continue to pull the pulling wire 275 until the free end of the implanting wire 271 is pulled out of the sheath 24, and then the operator can fix the end of the implanting wire 271 on the ventricular wall, papillary muscle or apex, and use the implanting wire 271 to replace the natural chordae tendineae to maintain the tension between the leaflet and the ventricular wall.

[0062] A group of implantation wires 271 and a group of pull wires 275 are arranged in the clamp assembly 22 and the sheath 24 of the transcatheter suture implantation device 20 provided by the present invention. After the puncture member 251 punctures the valve leaflet, it is connected to the puncture connector 254. The withdrawal of the puncture member 251 can drive the puncture connector 254 and the implantation wire 271 to pass through the valve leaflet; then the movement of the pull wire 275 can pull the implantation wire 271 to the surface of the valve leaflet and pull out the sheath 24. It is easy to use and simple to operate. The implantation of the implantation wire 271 is driven by the flexible pull wire 275, which is more suitable for remote intervention and reduces the risk of surgery. In addition, all the tubes used in the device are flexible structures, which cause less damage to the human body and are suitable for remote intervention. The guide device 60 of the transcatheter chord implantation system 100 can adjust the distal position of the transcatheter suture implantation device 20, and the operation is simple.

[0063] like Figures 4 to 8 As shown, the implant wire 271 is folded in half and arranged in the inner cavity of the sheath 24. The folded part 273 of the implant wire 271 is located at the proximal end of the sheath 24, and the two free ends of the implant wire 271 are respectively connected to two puncture connectors 254, and the connection method can be various fixing methods such as knotting, winding, welding, bonding, and clamping. The implant wire 271 is a flexible wire, that is, the implant wire 271 can be bent arbitrarily without being stretched in the axial direction; the implant wire 271 can be made of a biocompatible polymer material or a relatively soft metal material, preferably a polymer material such as PTFE, e-PTFE, PET, etc. In this embodiment, e-PTFE wire is used.

[0064] The pull wire 275 is also a flexible wire, which can be made of polymer materials, such as single or multiple strands made of one or more materials of PP, PE, PET, PTFE, e-PTFE, PEBAX; or it can be made of flexible metal materials, such as single or multiple strands made of one or more mixed materials of stainless steel, copper, iron, nickel titanium. The materials of the pull wire 275 and the implant wire 271 can be the same or different. Preferably, the pull wire 275 is stronger than the implant wire 271 to facilitate pulling the implant wire 271.

[0065] like Figures 7 to 9 As shown, the puncture connector 254 is disposed in the proximal clamp 221. In this embodiment, the puncture connector 254 is two sleeves spaced apart from each other, and the end of the implantation line 271 is tied and fixedly connected to the puncture connector 254. Specifically, as Fig. 9 As shown, the puncture connector 254 has an accommodating cavity 2541 at one axial end thereof and a through hole 2543 communicating with the accommodating cavity 2541 at the other end thereof, and the inner diameter of the through hole 2543 is smaller than the inner diameter of the accommodating cavity 2541 . After the end of the implant wire 271 passes through the through hole 2543 and the accommodating chamber 2541 in turn, a knot is tied at the end of the implant wire 271 to form a ball of wire with a diameter larger than the inner diameter of the through hole 2543 and smaller than the inner diameter of the accommodating chamber 2541, or the end of the implant wire 271 is welded into a sphere with a diameter larger than the inner diameter of the through hole 2543 and smaller than the inner diameter of the accommodating chamber 2541, or a positioning rod is set at the end of the implant wire 271, and the axial direction of the positioning rod in the natural state is not coaxial with the axial direction of the implant wire 271 and the puncture connector 254. After the positioning rod and one end of the implant wire 271 pass through the puncture connector 254, the positioning rod returns to the natural state, that is, the positioning rod is stuck on the step surface between the accommodating chamber 2541 and the through hole 2543 of the puncture connector 254, thereby fixing one end of the implant wire 271 in the puncture connector 254.

[0066] The puncture member 251 is disposed in the distal clamp 225. One end of each puncture member 251 is used to puncture the valve leaflet, and the other end is connected to the distal clamp 225 through a puncture traction rod. The proximal end of the puncture traction rod extends into the sheath 24. When the puncture traction rod is controlled, the puncture member 251 can move forward and backward with it, so that the puncture member 251 is connected to the puncture connector 254, and moves distally with the implantation line 271, thereby realizing the function of the implantation line 271 passing through the valve leaflet. In this embodiment, the puncture member 251 is a puncture needle with two corresponding sleeves arranged in the distal clamp 225 at intervals. After the puncture needle passes through the valve leaflet, it can be detachably or non-detachably fixedly plugged into the corresponding puncture connector 254. In order to facilitate puncture and reduce the diameter of the puncture point formed on the leaflet, the needle of the puncture member 251 is preferably a tapered straight tip, so that the diameter of the puncture point formed on the leaflet ranges from 0.3 mm to 2 mm, and further, is controlled to be about 0.7 mm. The puncture member 251 and the puncture traction rod are preferably made of metal materials, such as stainless steel, and can be connected by welding technology, or can be selected from polymer materials with relatively high strength, such as PEEK tubes, PA tubes, etc., for mechanical connection such as bonding, threading, etc.

[0067] Specifically, a conical sharp portion 2510 is provided at the distal end of the puncture member 251, and a receiving cavity 2541 for receiving the sharp portion 2510 is provided on the side of the puncture connector 254 facing the puncture member 251. The shape of the receiving cavity 2541 needs to match the shape of the sharp portion 2510 of the puncture member 251, and is generally a conical cavity or a cylindrical cavity. The outer overall shape of the puncture connector 254 can be cylindrical, and the cross-sectional shape of the puncture connector 254 can be various ring shapes such as a circular ring, an elliptical ring, a polygonal ring, etc., preferably a circular ring and an elliptical ring.

[0068] The inner side wall of the puncture connector 254 is provided with at least one groove or hole that forms an interference fit, a snap connection or a key connection with the needle 2510 of the puncture member 251. In this embodiment, the inner side wall of the puncture connector 254 is radially provided with three grooves to ensure the connection stability between the puncture connector 254 and the puncture member 251 and reduce the shaking amplitude of the puncture member 251 after connection.

[0069] like Figure 7 and Figure 8 As shown, in order to increase the point contact between the implant wire 271 and the leaflet to surface contact, thereby reducing the risk of the artificial chordae tearing the leaflet, an anti-slip part 272 is sleeved on the implant wire 271. In the process of pulling the wire 275 to drive the implant wire 271 to move, the implant wire 271 is pulled out of the sheath 24, and then the implant wire 271 is pulled proximally. The implant wire 271 drives the anti-slip part 272 to move until the anti-slip part 272 is driven by the implant wire 271 to the puncture point and fits the surface of the leaflet. The anti-slip part 272 is fixed on the leaflet together with the implant wire 271 to prevent the leaflet from tearing.

[0070] Preferably, the anti-slip member 272 has two through holes 2721 spaced apart along the thickness direction thereof, and the two ends of the implant wire 271 respectively pass through the two through holes 2721 and are connected to the two puncture connectors 254. In order to reduce the size of the sheath 24, the implant wire 271 and the anti-slip member 272 should be longitudinally placed in the chuck assembly 22, so the two through holes 2721 should be longitudinally staggered, that is, one through hole 2721 is located at the distal end, and the other through hole 2721 is located at the proximal end, and the line between the two through holes has a certain angle with the axial direction of the anti-slip member 272, so that the anti-slip member 272 can be placed in the chuck assembly 22 parallel to the implant wire 271.

[0071] The anti-slip part 272 is provided with a fitting surface 2723 that fits with the leaflet, and the fitting surface 2723 is away from the fold 273 of the implantation line 271. The anti-slip part 272 can be a sheet, disc or sphere with a certain area, or even an irregular shape, preferably a sheet. It can be a non-porous structure, or a mesh structure, a bar grid structure, etc., and is made of biocompatible materials, and can be made of elastic materials or non-elastic materials. Specifically, the anti-slip part 272 is selected from at least one of an elastic gasket, a heart patch, a felt sheet, a grid structure, a disc structure or a double disc structure. Among them, the structure of the anti-slip part 272 with a disc structure or a double disc structure is similar to the occluder in the prior art, which will not be repeated here.

[0072] Preferably, in order to reduce the overall size of the device, the anti-slip member 272 having a disc-shaped structure or a double disc-shaped structure should be made of a shape memory material. That is, when the anti-slip member 272 is accommodated in the clamp assembly 22, the anti-slip member 272 can shrink to a smaller volume, and after the anti-slip member 272 is separated from the clamp assembly 22, the anti-slip member 272 can automatically expand to increase the contact area between the anti-slip member 272 and the leaflet.

[0073] like Figures 4 to 6As shown, a plurality of mutually separated cavities are provided in the sheath 24 along the axial direction, and the central cavity is a guidewire cavity. The sheath 24 can be a one-piece multi-cavity tube, or the outer tube and the inner tube can be fixed together to form a sheath 24 of an integral structure. In this embodiment, the sheath 24 includes a hollow flexible outer tube, through which a plurality of flexible inner tubes are provided, the central one is used as a guidewire cavity, and the rest are respectively provided with components such as a pull line 275, an implantation line 271, and a puncture assembly 25. A control handle 21 is provided at the proximal end of the sheath 24 for manipulating the sheath 24 to push toward the distal end or withdraw toward the proximal end. The sheath 24 can be made of a biocompatible polymer material (for example, polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or polyurethane PU) or a metal material (for example, stainless steel or nickel-titanium alloy). The material of the flexible inner tube inserted in the sheath tube 24 can be a polymer material such as PI, PEBAX, PET, PA, PEEK, etc., or a flexible metal tube such as a nickel-titanium tube and a stainless steel tube, so as to facilitate remote intervention.

[0074] like Figure 4 and Fig.10 As shown, the distal end of the sheath tube 24 is provided with a connector 23, which is used to connect with the chuck assembly 22, and the connection method can be a tight mechanical connection such as gluing. The connector 23 has a distal surface 231 and a proximal surface 232, and an inner cavity 233 that runs through the proximal surface 232 and the distal surface 231. The distal surface 231 is matched and connected with the chuck assembly 22, and the connection method is a tight connection or a snap connection. The proximal surface 232 is matched and connected with the distal end of the sheath tube 24, and the connection method is a tight connection. The inner cavity 233 is used to accommodate components such as the proximal chuck 221 of the chuck assembly 22. Specifically, the distal end of the peripheral wall of the connector 23 is provided with a connecting hole 234 connected to the inner cavity 233, and the connecting hole 234 is used to connect the proximal chuck 221; the proximal end of the peripheral wall of the connector 23 is provided with a fixing hole 235 connected to the inner cavity 233, and the fixing hole 235 is used to fix the distal end of the connecting sheath tube 24. The connector 23 can be made of polymer, such as one or more of PP, PE, PET, PTFE, PEBAX, ABS. It can also be made of metal material, such as one or more of stainless steel, iron, copper, nickel titanium, platinum, gold.

[0075] like Fig.11As shown, in this embodiment, two probes 223 are slidably and symmetrically arranged in the sheath 24, and the distal ends of the probes 223 can extend from the proximal clamp 221, and the forward and backward movement of the probes 223 can be controlled by the control handle 21. When the clamp assembly 22 stably clamps the leaflets, the probes 223 are pushed to the distal end. When the probes 223 cannot enter the distal clamp 225 due to being blocked by the leaflets, it means that the leaflets are effectively clamped, and the operator can perform subsequent operations. The probe 223 can be a metal rod or a metal tube, or other polymer flexible rods or tubes. The probe 223 can also be made of thinner stainless steel wire and stainless steel sleeves by welding, gluing or other mechanical connection methods.

[0076] Please also read Figures 4 to 6 and Fig.12 The clamp assembly 22 also includes a clamping drive rod 2251 disposed between the proximal clamp 221 and the distal clamp 225. The clamping drive rod 2251 moves axially to drive the distal clamp 225 to move axially and open and close relative to the proximal clamp 221 to achieve the clamping of the leaflet. That is, the proximal clamp 221 and the distal clamp 225 are connected by the clamp drive rod 2251 disposed on the distal clamp 225. The distal clamp 225 is fixedly connected to the clamping drive rod 2251 by welding, bonding, threaded connection, etc. The clamping drive rod 2251 is preferably made of metal material, such as 304 stainless steel, 316 stainless steel or nickel titanium; it can also be a polymer material with higher strength, such as PEEK, POM, PA; it can also be a composite flexible tube assembly, such as a metal cutting tube. In this embodiment, a PEEK tube is used as the clamping drive rod.

[0077] In order to prevent the chuck assembly 22 from shaking and falling off due to excessive opening of the chuck, a guide rod 2253 is further provided between the proximal chuck 221 and the distal chuck 225, and the guide rod 2253 is symmetrically arranged with the chuck driving rod 2251. Specifically, the guide rod 2253 is arranged between the proximal chuck 221 and the distal chuck 225, and the guide rod 2253 is spaced parallel to the clamping driving rod 2251, and the distal chuck 225 can slide along the axial direction with the guide rod 2253.

[0078] like Figure 4-Figure 6 and Figure 12 to Figure 14As shown, a guidewire cavity 2211 is axially provided in the middle of the proximal chuck 221, and the guidewire cavity 2211 is used to insert a guidewire. The proximal end of the proximal chuck 221 is connected to the connector 23 by snapping and gluing, so as to be connected to the distal end of the sheath 24. In this embodiment, a buckle 2212 is provided at the proximal end of the proximal chuck 221 corresponding to the connecting hole 234 of the connector 23, and the buckle 2212 of the proximal chuck 221 is snapped into the connecting hole 234 corresponding to the connector 23, so that the proximal chuck 221 is fixedly connected to the connector 23. A clamping surface 2213 is provided at the distal end of the proximal chuck 221, and the clamping surface 2213 has an anti-slip structure for more effectively clamping the leaflet. The anti-slip structure can be one or more of concave-convex, corrugated, and threaded, preferably corrugated. Preferably, the clamping surface 2213 is inclined to the axial setting to facilitate the leaflet to slide onto the clamping surface 2213 and increase the area of ​​the clamping surface 2213. The proximal clamp 221 has multiple cavities, each of which can be individually inserted with a flexible inner tube, each of which extends to the back of the sheath 24 and passes through the proximal end of the sheath 24 or is connected to the control handle 21 for the convenience of the operator. The proximal clamp 221 can be made of polymer materials, such as one or more of PP, PE, PET, PTFE, PEBAX, ABS, and PC. It can also be a metal material, such as one or more of stainless steel, iron, copper, nickel titanium, platinum, and gold.

[0079] like Fig.14As shown, at least one probe cavity 2214 is axially provided inside the proximal clamp 221 on one side of the guidewire cavity 2211, and the distal end of the probe 223 can be slidably extended from the probe cavity 2214 to detect whether a leaflet is clamped between the proximal clamp 221 and the distal clamp 225; in this embodiment, two probe cavities 2214 are symmetrically provided on both sides of the guidewire cavity 2211 inside the proximal clamp 221. The proximal clamp 221 is provided with an implant receiving chamber 2215 on one side of the guide wire chamber 2211, and the implant receiving chamber 2215 is used to receive the implant wire 271 and the anti-slip member 272. The proximal clamp 221 is provided with puncture connector receiving chambers 2216 connected to the implant receiving chamber 2215 at both ends of the implant receiving chamber 2215 in the radial direction, and the puncture connector receiving chamber 2216 is used to receive the puncture connector 254. The pulling wire 275 drives the implant wire 271 to move out of the implant receiving chamber 2215, and the implant wire 271 is continuously pulled toward the proximal end to pull the anti-slip member 272 out of the implant receiving chamber 2215. The other side of the guide wire chamber 2211 is symmetrically provided with a clamping traction chamber 2217 and a guide rod chamber 2218, in which a clamping driving rod 2251 and a guide rod 2253 are respectively penetrated. The pull wire accommodating tube 228 is located in the middle of the clamping traction cavity 2217 and the guide rod cavity 2218. The proximal end of the pull wire accommodating tube 228 extends into the sheath tube 24. The side wall of the pull wire accommodating tube 228 is grooved to facilitate the distal end of the pull wire 275 to extend and the implant wire 271 to enter, that is, the proximal end of the pull wire 275 passes through the pull wire accommodating tube 228 and enters the sheath tube 24. Therefore, when in use, the operator can send the instrument along the guide wire through the guide wire cavity 2211 to the predetermined treatment site; drive the distal clamp 225 to open relative to the proximal clamp 221 through the clamping drive rod 2251 to clamp the leaflet, and at this time the guide rod 2253 can prevent the distal clamp 225 from falling off; detect the clamping state of the leaflet through the probe 223; drive the distal clamp 225 to approach the proximal clamp 221 through the clamping drive rod 2251, and drive the puncture member 251 set on the distal clamp 225 to puncture the leaflet and combine with the puncture connector 254 of the implant line 271; then pull the pull line 275, and the pull line 275 pulls the implant line 271 into the sheath 24 via the pull line accommodating tube 228.

[0080] Please also read Figure 4-Figure 6 and Figure 15-18The distal clamp 225 includes a clamp body 2250, a shell 2252 disposed at the distal end of the clamp body 2250, and a puncture base 2254 disposed at the proximal end of the clamp body 2250, and the puncture base 2254 and the implant receiving cavity 2215 are located on the corresponding side. A guide wire cavity 2255 is axially provided at the center of the clamp body 2250. The distal clamp 225 is provided with two puncture channels 2256 along the axial direction, and the two puncture channels 2256 penetrate the puncture base 2254, and the two puncture members 251 are slidably received in the two puncture channels 2256 respectively. The two puncture channels 2256 correspond to the puncture connector receiving cavity 2216 of the proximal clamp 221, so that the puncture member 251 corresponds to the puncture connector 254. In order to clamp the valve leaflet more effectively, the clamping surface of the distal clamp 225 has an anti-slip structure. The anti-slip structure may be one or more of concave-convex, corrugated, and threaded, preferably corrugated. Preferably, the clamping surface of the distal clamp 225 is inclined to the axial setting to facilitate the leaflet to slide between the clamping surface 2213 of the proximal clamp 221 and the clamping surface of the distal clamp 225 and increase the clamping area. The proximal end of the clamp body 2250 is provided with two probe cavities 2257 on both sides of the guidewire cavity 2255, and the two probe cavities 2257 are used to accommodate the distal ends of the two probes 223. The chuck body 2250 is provided with a symmetrical clamping and traction cavity 2258 and a guide rod cavity 2268 on the other side of the guide wire cavity 2255, through which the distal ends of the clamping drive rod 2251 and the guide rod 2253 are respectively passed; the chuck body 2250 is provided with a pulling wire connecting cavity 2259 axially in the middle of the clamping and traction cavity 2258 and the guide rod cavity 2268, and the distal end of the pulling wire accommodating tube 228 is arranged in the pulling wire connecting cavity 2259.

[0081] like Fig.18 and Fig.19As shown, an arc-shaped pull-wire accommodating cavity 2755 is provided between the inner wall of the chuck body 2250 of the distal chuck 225 and the inner wall of the puncture base 2254. The distal end of the pull-wire 275 extends out from the side wall of the pull-wire accommodating tube 228 and is installed in the arc-shaped pull-wire accommodating cavity 2755, so that the bent portion 2750 at the distal end of the pull-wire 275 is U-shaped and bypasses the proximal ends of the two puncture members 251 and is accommodated in the distal chuck 225. When the puncture member 251 is combined with the puncture connector 254, the puncture member 251 can drive the implantation wire 271 to pass through the leaflet. At this time, the end of the puncture member 251 is away from the pulling wire 275, and the implantation wire 271 enters the curved portion 2750 of the pulling wire 275. At this time, by pulling the pulling wire 275, the pulling wire 275 can drive the implantation wire 271 to move until the implantation wire 271 is pulled out of the implantation member accommodating cavity 2215 of the proximal clamp 221 and attached to the lower surface of the leaflet, the anti-slip member 272 fits with the lower surface of the leaflet, and the implantation wire 271 enters the sheath 24 from the side wall of the pulling wire accommodating tube 228 and extends from the proximal end of the sheath 24, and then the transcatheter suture implantation device 20 is withdrawn, the implantation wire 271 is cut as needed, and the end of the implantation wire 271 is fixed to the ventricular wall and other parts.

[0082] Since both the chuck assembly 22 and the sheath 24 need to reach the predetermined location through remote intervention, each connecting rod installed in the chuck assembly 22 and the sheath 24 (such as the clamping drive rod, the guide rod, the puncture traction rod, the pull wire accommodating tube, and the probe) needs to have both flexibility and rigidity. Preferably, the two ends of the connecting rod have good rigidity, and the middle part has good flexibility while maintaining rigidity, thereby reducing the resistance to chuck bending, chuck opening and closing, probe detection, and puncture.

[0083] See also Figure 20-23 Various embodiments of the aforementioned connecting rod are shown, such as Fig. 20 As shown in FIG. 1 , the portion of the stainless steel tube near the distal end is alternately grooved along the circumferential direction, so that the distal end has both rigidity and flexibility. Fig.21 As shown, the far end of the stainless steel tube is a section of stainless steel rod or steel tube, and the near end of the steel tube is connected to a section of flexible steel cable core (made of multiple strands of thin steel wires). The steel cable core is an adjustable bending section, and the near end of the steel cable core is connected to a section of stainless steel tube or stainless steel rod. The connection method between the steel cable core and the stainless steel rod or steel tube is preferably laser welding, and mechanical connection methods such as threads can also be used. Therefore, the far end stainless steel tube or stainless steel rod has full rigidity and surface smoothness to ensure smooth and reliable guidance. The far end can rely on the flexibility of the steel cable core to meet the bending requirements, and the near end guarantees sufficient rigidity and support. Fig. 22 and Fig.23As shown, in another embodiment, the two ends are steel pipes, a nickel-titanium wire is passed through the middle of the steel pipe, and the nickel-titanium wire is welded or mechanically compressed to the steel pipes at both ends; a spring is provided between the steel pipes at both ends, and the spring is squeezed between the steel pipes, thereby, the two ends can maintain a certain rigidity, and the middle section has good flexibility and rigidity.

[0084] See also Figure 3-Figure 5 and Figure 24-25 In order to facilitate remote operation in vitro, the transcatheter suture implantation device 20 is also provided with a control handle 21. Specifically, the control handle 21 is arranged at the proximal end of the sheath 24, and is used to drive the opening and closing of the chuck assembly 22, the movement of the puncture assembly 25, the movement of the probe 223 and the pull line 275. The handle 21 includes a housing 211, a drive assembly and a probe display board 212. The drive assembly is installed in the housing 211, and the probe display board 212 is arranged on the housing 211 to indicate the position of the probe 223 to the operator. The housing 211 is connected to the proximal end of the sheath 24 through a rotating wheel 213, and the connection method can adopt other mechanical connection methods such as bonding, injection molding connection, and threaded connection. The rotating wheel 213 can drive the sheath 24 and the internal components of the sheath 24 to rotate. Through the overall movement of the handle 21, the sheath 24 can be driven to move forward to the distal end or retreat to the proximal end, thereby driving the movement of the transcatheter suture implantation device 20, so that the chuck assembly 22 can smoothly reach the specified position.

[0085] The drive assembly includes a clamping drive 214 for controlling the opening and closing of the clamp assembly 22, a probe drive 215 for controlling the movement of the probe 223, a puncture drive 216 for controlling the movement of the puncture member 251, and a pull-wire drive 217 for controlling the pull wire 275. Among them, a linkage mechanism connecting the clamping drive 214 and the puncture drive 216 is provided between the clamping drive 214 and the puncture drive 216, and the clamping drive 214 and the puncture drive 216 can be controlled separately through the linkage mechanism. The clamping drive 214 is connected to the distal clamp 225 through the clamping drive rod 2251. The probe drive 215 is connected to the proximal end of the probe 223, and its movement can drive the two probes 223 to move forward or backward for a certain distance. The puncture drive 216 is connected to the puncture traction rod, which can drive the puncture member 251 to move forward and backward to achieve the function of puncturing the valve leaflet. The pull-wire driver 217 is connected to the pull-wire 275 . When the puncture member 251 and the puncture connector 254 are retracted, the pull-wire driver 217 can drive the pull-wire 275 to move, thereby driving the implant wire 271 to be pulled from the clamp assembly 22 to the tail end of the handle 21 .

[0086] All components of the control handle 21 can be made of polymer materials, such as ABS, PC, POM, PA, etc., or metal materials, such as stainless steel, aluminum alloy, etc., or a combination of multiple materials. ABS and PC are used in this embodiment.

[0087] Please also read Figure 3 and Figure 26-Figure 27 The guide device 60 includes an adjustable curved tube 61 with a certain axial length and a bending mechanism 62. The distal end of the adjustable curved tube 61 is provided with at least one adjustable curved section 611. The bending mechanism 62 includes a bending adjusting member 621 provided at the proximal end of the adjustable curved tube 61 and an adjusting wire 601 passing through the adjustable curved tube 61. The distal end of the adjusting wire 601 is connected to the adjustable curved section 611. The bending adjusting member 621 pulls the adjusting wire 601 to bend the adjustable curved section 611 to adjust the distal end position of the transcatheter suture implantation device 20. For ease of operation, a bending adjusting handle 605 is also provided at the proximal end of the adjustable curved tube 61. The bending adjusting member 621 is provided on the bending adjusting handle 605.

[0088] like Fig. 27 As shown, at least one traction wire channel 613 is opened in the tube wall of the adjustable bend tube 61 along its axial direction, the distal end of the traction wire channel 613 extends to the distal end of the adjustable bend section 611, and the proximal end of the traction wire channel 613 extends to the bending adjustment handle 605. An adjusting wire 601 is inserted in the traction wire channel 613, the distal end of the adjusting wire 601 is connected to the distal end of the adjustable bend section 611, and the proximal end of the adjusting wire 601 is connected to the bending adjustment piece 621. By pulling the adjusting wire 601 toward the proximal end through the bending adjustment piece 621, the adjustable bend section 611 can bend toward the side of the pulled adjusting wire 601; when the pulling force on the adjusting wire 601 is released, the adjustable bend section 611 automatically resets. Preferably, a plurality of mutually spaced traction wire channels 613 are opened in the tube wall of the adjustable bend tube 61 along its axial direction, and the plurality of traction wire channels 613 are arranged along the circumference of the adjustable bend tube 61. An adjustment wire 601 is inserted into each traction wire channel 613. By pulling each adjustment wire 601 proximally through the bending handle 605, the adjustable bend section 611 can be bent toward the side of the pulled adjustment wire 601, so that the adjustable bend section 611 can be bent in different directions, so that the adjustable bend tube 61 can adapt to the requirements of the curved human tubular cavity structure.

[0089] One end of the adjusting wire 601 connected to the adjustable curved section 611 is provided with an anchoring ring 603, and the anchoring ring 603 is fixedly sleeved on the adjustable curved section 611, that is, the distal end of the adjusting wire 601 is connected to the adjustable curved section 611 through the anchoring ring 603. The anchoring ring 603 can be made of a metal material or a polymer material. In this embodiment, the anchoring ring 603 is made of 304 stainless steel. The way of connecting the adjusting wire 601 to the anchoring ring 603 includes but is not limited to bonding, welding, hot melting, knotting, etc., which are not limited here.

[0090] The outer cover of the adjusting wire 601 is provided with a wire wrapping tube 606, and the part of the adjusting wire 601 located in the tube body is movably arranged in the wire wrapping tube 606. The wire wrapping tube 606 limits the pulling direction of the adjusting wire 601 and protects the adjusting wire 601. The hardness of the part of the wire wrapping tube 606 corresponding to the adjustable curved section 611 should be less than the hardness of other parts, that is, the part of the wire wrapping tube 606 corresponding to the adjustable curved section 611 is flexible, so as not to affect the bending of the adjustable curved section 611. For example, the part of the wire wrapping tube 606 embedded in the adjustable curved section 611 can be made of a softer PTFE thin tube, while the other parts can be made of a PI thin tube or a stainless steel thin tube.

[0091] See also Figure 28-Figure 37 The diagram shows the process of the clamp assembly 22 opening and clamping the valve leaflet, the puncture assembly 25 withdrawing after puncturing the valve leaflet, and the pulling line 275 pulling back the implantation line 271 .

[0092] Figure 28-Figure 29 The initial state of the clamp assembly is shown, at which time the proximal clamp 221 and the distal clamp 225 are closed, and the clamp assembly 22 is driven to rotate or move forward and backward as a whole by the control handle 21. The implantation line 271 and the anti-slip member 272 are pre-installed in the proximal clamp 221 and the sheath 24, the puncture member 251 is pre-installed in the distal clamp 225, and the end of the puncture member 251 is arranged corresponding to the puncture connectors 254 at both ends of the implantation line 271. The curved portion 2750 at the distal end of the pull line 275 is pre-installed in the distal clamp 225, the loop curved portion 2750 is arranged around the outside of the two puncture members 251, and the proximal end of the pull line 275 extends from the proximal clamp 221 and the sheath 24 to the outside of the patient's body in sequence.

[0093] Figure 30-Figure 31 The clamp assembly 22 is shown in an open state, and the distal clamp 225 is moved distally by clamping the driving rod 2251 , at which time a leaflet accommodating space 224 is formed between the proximal clamp 221 and the distal clamp 225 .

[0094] Fig.32 It is shown that after the clamp assembly 22 is opened, the position and state of the leaflet are observed through ultrasound or other medical imaging equipment, and the position of the clamp assembly 22 is adjusted until the leaflet enters the leaflet accommodating space 224 between the proximal clamp 221 and the distal clamp 225.

[0095] Fig.33 The clamp assembly 22 is shown closed until the leaflet is stably clamped between the proximal clamp 221 and the distal clamp 225.

[0096] Figure 34-Figure 35 It is shown that the piercing member 251 passes through the leaflet and is connected with the piercing connector 254 in the proximal clamp 221.

[0097] Fig.36It shows that the puncture member 251 is withdrawn, driving the puncture connector 254 and the implantation wire 271 connected to the puncture connector 254 to pass through the valve leaflet. At this time, the implantation wire 271 enters the curved portion 2750 at the distal end of the pulling wire 275.

[0098] Fig.37 It is shown that the pull wire 275 is pulled proximally, thereby driving the implant wire 271 to move proximally with it until the implant wire 271 enters the pull wire accommodating tube 228 from the side wall of the pull wire accommodating tube 228 and enters the sheath 24, after which the implant wire 271 can be pulled out from the proximal end of the sheath 24 and the control handle 21.

[0099] Please also read Figure 38-Figure 50 The following uses the transcatheter mitral valve artificial chord repair as an example to illustrate the use of the transcatheter chord implantation system provided by the present invention. The surgical route is: via the femoral vein - inferior vena cava - left ventricle - atrial septum - left atrium - mitral valve.

[0100] Step 1: Puncture the femoral vein and insert a guide wire (not shown) to the left ventricle. Then, puncture the oval fossa of the atrial septum with an atrial septal puncture needle or other instruments (not shown). Send the guide wire from the left ventricle to the left atrium and reach the vicinity of the mitral valve, thereby establishing a track from the outside to the inside of the body.

[0101] Step 2: If Figure 38-Figure 39 As shown, the sheath tube 24 of the transcatheter suture implantation device 20 is inserted into the guide device 60, and the clamp assembly 22 extends from the distal end of the adjustable curved tube 61 of the guide device 60. The two reach the left atrium along the guide wire, and the distal end of the transcatheter suture implantation device 20 is continuously advanced and adjusted in position through the guide device 60 until the clamp assembly 22 reaches the vicinity of the mitral valve and is located between the anterior leaflet and the posterior leaflet.

[0102] Step 3: If Figure 40-41 As shown, the clamping driving member 214 on the control handle 21 is operated to open the distal clamp 225 and the proximal clamp 221, and the leaflet is adjusted to the leaflet accommodating space 224 between the distal clamp 225 and the proximal clamp 221 by operating the bending adjustment handle 605 and the control handle 21 and adjusting the opening and closing distance of the clamp assembly 22;

[0103] Step 4: If Fig.42 As shown, the clamping driving member 214 on the control handle 21 is operated to retract the distal clamp 225 until the leaflet is stably clamped between the proximal clamp 221 and the distal clamp 225;

[0104] Step 5: Control the probe 223 to move distally by the probe driving member 215 on the control handle 21. If the leaflet is clamped, the probe 223 will be blocked by the leaflet and cannot continue to move distally. The operator can visually observe whether the movement distance of the probe 223 is in the position where the leaflet has been stably clamped by the probe display board 212 on the control handle 21. If it is displayed that the leaflet has not been clamped successfully, repeat steps 3 and 4 until the movement distance of the probe 223 is appropriate, which indicates that the leaflet has been stably clamped. At this time, the relative positions of the puncture member 251, the puncture connector 254, the implantation line 271, and the pulling line 275 are as shown in FIG. Fig.43 shown.

[0105] Step 6: If Fig.44 , operate the puncture drive member 216 on the control handle 21, drive the puncture member 251 to pass through the valve leaflet, insert into the puncture connector 254, and achieve the matching connection with the puncture connector 254. At this time, the relative positions of the puncture member 251, the puncture connector 254, the implantation wire 271, and the pulling wire 275 are as shown in FIG. Fig.45 shown.

[0106] Step 7: If Fig.46 As shown, the puncture drive member 216 on the operating control handle 21 drives the puncture member 251 to retract. Since the puncture member 251 and the puncture connector 254 are already connected at this time, the puncture connector 254 will move with the retraction of the puncture member 251, thereby driving the implantation wire 271 to pass through the leaflet and enter the curved portion 2750 bent by the pulling wire 275.

[0107] Step 8: Figure 47 to Figure 48 As shown, by pulling the pull wire drive 217 on the control handle 21, the pull wire 275 is pulled back in the direction indicated by the arrow, thereby driving the implant wire 271 in the curved portion 2750 to retreat until the anti-slip member 272 is driven to the lower surface of the leaflet, and the implant wire 271 moves to the outer end of the control handle 21.

[0108] Step 9: Determine the appropriate length of the artificial tendon according to the medical image, and cut the implanted wire 271 pulled outside the body as needed, and fix the cut end to the ventricular wall, papillary muscle or apex.

[0109] Step 10: If Fig.49 and Fig.50 As shown, the transcatheter suture implantation device 20 and the guide device 60 are withdrawn from the patient's body to complete the operation. The anti-slip member 272 and the implantation line 271 remain in the body. One end of the implantation line 271 is fixed to the leaflet in a U shape through the anti-slip member 272 to replace the diseased chordae tendineae and maintain the tension between the leaflet and the ventricular wall.

[0110] Fig.51and Fig.52 The second embodiment of the present invention is shown. Compared with the first embodiment, the housing 2252 of the distal clamp 225 is cancelled, and an end cap 2501 is provided at the distal end of the clamp body 2250. The end cap 2501 is made of metal and has a smooth structure to facilitate the instrument access. As a result, the overall size of the clamp assembly 22 can be effectively reduced, the smoothness of the surgical operation can be improved, and the friction damage of the clamp assembly 22 to the heart during the operation can be reduced; and the metal end cap 2501 can improve the connection strength and increase the reliability of the instrument.

[0111] Fig.53 The third embodiment of the present invention is shown. Compared with the second embodiment, an independent guide rod 250 is added between the proximal chuck 221 and the distal chuck 225. One end of the guide rod 250 has a limiting portion 2503 of a cylindrical or triangular or other geometric shape. The limiting portion 2503 is arranged in the proximal chuck 221. Since the limiting portion 2503 has an axial limiting effect on the proximal chuck 221, the maximum opening and closing amount of the chuck assembly 22 can be controlled. The other end of the guide rod 250 passes through the distal chuck 225 and is fixedly connected to the chuck body 2250 by laser welding, bonding, threading, etc. In this way, the stability of the overall chuck assembly 22 can be improved, especially when the chuck assembly 22 is opened and closed and there is relative movement between the internal components, the stability of the movement can be improved to prevent the chuck from shaking and falling off.

[0112] Fig.54 The fourth embodiment of the present invention is shown. Compared with the third embodiment, the plane 2505 that is in contact with the curved portion 2750 is tilted to adjust the angle of the embedded curved portion 2750 in the embedded position, so that the open end of the curved portion 2750 is biased toward the proximal end of the distal clamp 225, and the plane 2505 forms an acute angle with the direction of the puncture member, which can effectively reduce the tension when pulling the wire 275, thereby reducing the tension on the clamp assembly 22 as a whole, and effectively improving the instrument stability and surgical stability during the surgical operation.

[0113] Fig.55 and Fig.56 The fifth embodiment of the present invention is shown. Compared with the first embodiment, a limiting groove 2506 is added inside the distal clamp 225. When the curved portion 2750 of the pull line 275 is assembled to the distal clamp 225, it is pre-buried in the limiting groove 2506. The limiting groove 2506 can prevent the pre-buried curved portion 2750 from affecting the movement of the puncture member 251. In addition, the limiting groove 2506 can prevent the curved portion 2750 from being separated in advance. Even if the puncture member 251 is withdrawn by mistake before puncturing, the curved portion 2750 can be prevented from being separated from the puncture member 251 and passing over the puncture member 251, and the curved portion 2750 is kept in the outer ring of the puncture member 251 to ensure the effectiveness of the pull line 275.

[0114] Fig.57 and Fig.58 The sixth embodiment of the present invention is shown. This embodiment adjusts the connection mode between the implantation wire 271 and the puncture connector 254 from a non-detachable connection to a detachable connection, so that the implantation wire 271 can be separated from the puncture connector 254 during the pulling process of the pulling wire 275, thereby reducing the tension on the clamp assembly 22 during the pulling process, and reducing the pulling force on the leaflets to a minimum, thereby reducing damage to the leaflets; and because the puncture connector 254 and the implantation wire 271 are separated when pulling force is applied to the pulling wire 275, the required length of the implantation wire 271 is greatly reduced, thereby reducing the cost and difficulty of use of the device.

[0115] like Fig.57 As shown, the implant wire 271 inserted into the puncture connector 254 is pre-tightened by wire crimping pliers or other pressure mechanisms, and the pre-tightening force is sufficient to drive it through the leaflet. When the pull wire 275 is pulled, the force applied by the pull wire 275 is sufficient to pull the pull wire 275 out of the puncture connector 254.

[0116] like Fig.58 As shown, a wire 2507 is added between the puncture connector 254 and the implantation wire 271 for connection. Both ends of the wire 2507 are fixedly connected to the puncture connector 254 by crimping, welding, gluing or other mechanical connection methods. The middle part of the wire 2507 clamps the free end of the implantation wire 271 between the wire 2507 and the puncture connector 254. The clamping force is adjusted to a reasonable level. When the pulling wire 275 is pulled, the free end of the implantation wire 271 is separated from the puncture connector 254 and pulled out.

[0117] In addition, a groove may be formed on the puncture connector 254, and the implantation wire 271 may be hung in the groove, so that the implantation wire 271 can be separated from the puncture connector 254 when the wire is pulled.

[0118] In this embodiment, since the free end of the implantation line 271 can be separated from the puncture connector 254, the following method can be used: Fig.59 The distal curved portion shown is a pull line of the knot 508 for pulling the wire. When force is applied, the knot 508 automatically locks the implant wire 271 to pull the implant wire 271 out of the body by pulling the wire 275.

[0119] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A transcatheter suture implantation device, It is characterized in that The invention comprises a clamp assembly that can be relatively opened and closed, a bendable sheath connected to the proximal end of the clamp assembly, a puncture assembly arranged in the clamp assembly, a group of implantation lines and a group of pulling lines, the puncture assembly comprises a puncture piece slidably arranged on the clamp assembly and a puncture connecting piece corresponding to the puncture piece, after a group of implantation lines are folded in half, the two ends of the implantation lines are respectively connected to the two puncture connecting pieces; the clamp assembly comprises a proximal clamp and a distal clamp that can be relatively opened and closed, the implantation line and the puncture connecting piece are arranged on the proximal clamp, the puncture The piercing member is arranged on the distal clamp, and the pulling wire includes a curved portion pre-installed in the distal clamp and bypassing the outer sides of the two piercing members, and the proximal end of the pulling wire passes through the proximal end of the sheath; the piercing member can be driven to extend out of the distal clamp and connect with the piercing connector, and also drive the piercing connector and the implant wire to withdraw to the distal clamp so that the implant wire enters the curved portion of the pulling wire, and the pulling wire withdraws to drive the implant wire into the sheath until the implant wire is pulled out of the sheath.

2. The transcatheter suture implantation device according to claim 1, It is characterized in that The clamp assembly also includes a clamping drive rod disposed between the proximal clamp and the distal clamp. The clamping drive rod moves axially to drive the distal clamp to open and close relative to the proximal clamp.

3. The transcatheter suture implantation device according to claim 2, It is characterized in that The puncture connector is a sleeve spaced apart from each other in the proximal clamp, and the puncture member is a puncture needle corresponding to the sleeve arranged in the distal clamp. After the two puncture needles pass through the leaflets, they are detachably fixed or non-detachably fixedly connected to the corresponding sleeves.

4. The transcatheter suture implantation device according to claim 3, It is characterized in that The puncture needle comprises a tapered needle head, and a receiving cavity for receiving the needle head is provided on a side of the sleeve facing the puncture needle.

5. The transcatheter suture implantation device according to claim 2, It is characterized in that The clamp assembly also includes a guide rod disposed between the proximal clamp and the distal clamp, the guide rod is spaced and parallel to the clamping drive rod, and the distal clamp can slide axially along the guide rod.

6. The transcatheter suture implantation device according to claim 5, It is characterized in that The clamp assembly further comprises a probe slidably disposed in the sheath, wherein a distal end of the probe extends from the proximal clamp to detect a leaflet between the proximal clamp and the distal clamp.

7. The transcatheter suture implantation device according to claim 6, It is characterized in that A guidewire cavity is axially provided in the middle of the proximal chuck, and at least one probe cavity is axially provided on one side of the guidewire cavity; at least one clamping and traction cavity is axially provided on one side of the guidewire cavity, and the clamping drive rod is accommodated in the clamping and traction cavity; the proximal chuck is axially provided with a connecting cavity on one side of the clamping and traction cavity, and the proximal end of the guide rod is arranged in the connecting cavity.

8. The transcatheter suture implantation device according to claim 1, It is characterized in that The implantation wire and the pull wire are both flexible wires made of biocompatible polymer materials or relatively soft metal materials. The lengths of the implantation wire and the pull wire are both greater than twice the length of the sheath tube.

9. The transcatheter suture implantation device according to claim 8, It is characterized in that An anti-slip part is slidably mounted on the implantation wire, and the distal end of the implantation wire is bent to form a curved portion, and the anti-slip part is located at the curved portion. In the process of the implantation wire being driven to move by the pulling wire, the implantation wire drives the anti-slip part to move until the anti-slip part fits the surface of the leaflet.

10. The transcatheter suture implantation device according to claim 9, It is characterized in that The anti-slip part has two through holes spaced apart along its thickness direction, a line connecting the two through holes has a certain angle with the axial direction of the anti-slip part, and two ends of the implant wire are connected to two puncture connectors after passing through the two through holes respectively.

11. The transcatheter suture implantation device according to claim 9, It is characterized in that The chuck assembly has an implant accommodating cavity axially formed therein, the anti-slip member is detachably accommodated in the implant accommodating cavity, the implant wire and the puncture connector are accommodated in the implant accommodating cavity, the pulling wire drives the implant wire to move out of the implant accommodating cavity, and pulling the implant wire proximally can pull the anti-slip member out of the implant accommodating cavity.

12. The transcatheter suture implantation device according to claim 11, It is characterized in that The distal clamp has two puncture channels axially formed therein, and the two puncture members are respectively accommodated in the two puncture channels. The two puncture channels correspond to the puncture connectors on both sides of the implant accommodating cavity, so that the puncture members correspond to the puncture connectors.

13. The transcatheter suture implantation device according to claim 11, It is characterized in that The clamp assembly is provided with a pull wire accommodating tube, the proximal end of the pull wire accommodating tube passes through the proximal clamp to connect with the sheath tube, the bent portion of the pull wire is accommodated in the distal end of the pull wire accommodating cavity, and the proximal end of the pull wire enters the sheath tube from the pull wire accommodating cavity.

14. The transcatheter suture implantation device according to claim 2, It is characterized in that The distal end of the distal chuck is provided with an end cover, the proximal end of the end cover is axially provided with a guide rod, the proximal end of the guide rod is provided with a limiting portion that stops the proximal chuck, and the distal chuck can be slidably sleeved on the guide rod.

15. The transcatheter suture implantation device according to claim 14, It is characterized in that The end cap is a smooth structure made of metal.

16. The transcatheter suture implantation device according to claim 2, It is characterized in that The contact surface in the distal clamp that fits the curved portion of the pull line is inclined, and the open end of the curved portion is biased toward the proximal end of the distal clamp, so that the curved portion forms an acute angle with the moving direction of the puncture member.

17. The transcatheter suture implantation device according to claim 2, It is characterized in that A limiting groove is provided on a contact surface of the distal clamp that fits with the curved portion of the pulling wire. The limiting groove surrounds the two puncture connectors, and the curved portion of the pulling wire is accommodated in the limiting groove.

18. The transcatheter suture implantation device according to claim 1, It is characterized in that The end of the implantation wire is detachably connected to the puncture connector, and the implantation wire is disconnected from the puncture connector during the process of the pulling wire driving the implantation wire.

19. The transcatheter suture implantation device according to any one of claims 1 to 18, It is characterized in that The transcatheter suture implantation device also includes a control handle, which is used to drive the clamp assembly to open and close relative to clamp the leaflet, control the probe to detect the leaflet, drive the puncture member to puncture the leaflet, and drive the pull line to withdraw.

20. A transcatheter chordal implantation system, It is characterized in that It comprises a transcatheter suture implantation device and a guide device as described in any one of claims 1 to 19, wherein the transcatheter suture implantation device is movably installed in the guide device, the guide device comprises an adjustable bend tube and a bend adjustment mechanism arranged at the proximal end of the adjustable bend tube, the clamp assembly extends from the distal end of the adjustable bend tube, the distal end of the adjustable bend tube is provided with at least one adjustable bend section, the bend adjustment mechanism comprises a bend adjustment piece arranged at the proximal end of the adjustable bend tube and an adjustment wire connected to the bend adjustment piece, the distal end of the adjustment wire is connected to the adjustable bend section, the bend adjustment piece pulls the adjustment wire to bend the adjustable bend section to adjust the distal position of the transcatheter suture implantation device.

21. The transcatheter chordal implantation system according to claim 20, It is characterized in that At least one adjusting wire channel is axially opened in the wall of the adjustable bend pipe, the adjusting wire is inserted into the adjusting wire channel, an adjusting ring is embedded in the adjustable bend section, and the distal end of the adjusting wire is connected to the adjusting ring.

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