Interventional suture implantation device and interventional tendon chord implantation system

Abstract

The present invention provides an interventional suture implantation device, comprising a chuck assembly that opens and closes relatively axially, a sheath connected to the proximal end of the chuck assembly, two puncture members movably arranged in the chuck assembly, and a pulling member movably arranged in the chuck assembly and the sheath; the chuck assembly is provided with two puncture channels corresponding to the two puncture members, and the pulling member includes a curved portion preinstalled in the chuck assembly and surrounding the two puncture channels; at least one suture is folded in half and arranged in the chuck assembly, and the two free ends of the suture are respectively movably connected to the distal ends of the two puncture members, and the puncture member drives the suture into the curved portion, and after the puncture member is withdrawn to separate from the suture, the suture is locked by the curved portion and driven into the sheath. The present invention also provides an interventional chord implantation system comprising the interventional suture implantation device. The interventional chord implantation system and interventional suture implantation device provided by the present invention are easy to use, simple to operate, reduce the difficulty and risk of surgery, and are suitable for remote intervention.

Description

Technical Field

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

[0002] The mitral valve is a one-way valve between the left atrium and the left 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 chords, 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 time, and a painful recovery process.

[0004] Another treatment method is to implant sutures as artificial chordae in a minimally invasive manner. For example, a suture with a non-slip component is implanted on the surface of the mitral valve leaflet on the left atrial side through a transapical route to serve as an artificial chord to maintain the tension of the ventricular wall on the leaflet. The prior art transapical artificial chord implantation device includes an openable and closable clamp at the distal end, and a rigid puncture assembly is included inside the clamp. After the puncture assembly punctures the leaflet, it combines with the suture and then withdraws to drive the suture through the leaflet to achieve artificial chord implantation. However, this type of chord implant device cannot be used for remote intervention. The analysis is as follows: the transapical path is shorter. In order to ensure the reliability of puncturing the valve leaflets, the puncture component is made of rigid materials and structures. If it is changed to remote intervention, in order to ensure that the anti-slip part is 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 curved, and the instrument delivery system also needs to have good flexibility. Its rigid puncture component is difficult to pass through complex vascular paths. If its rigid puncture component is changed to flexible materials and structures, the puncture force loss is large under such a curved surgical path. It is difficult for the puncture component to penetrate the valve leaflets into the sleeve and form a fixed connection with the sleeve. It is also difficult to withdraw the suture by withdrawing a rigid sleeve of a certain length. Summary of the invention

[0005] The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, the present invention provides an interventional suture implantation device and an interventional chord implantation system, which implants at least one set of sutures as artificial chords into the leaflets of the mitral valve in a minimally invasive manner, and then fixes the ends of the sutures to the ventricular wall, papillary muscle or apex of the heart, replacing natural chords with sutures.

[0006] To solve the above technical problems, the present invention provides an interventional suture implantation device, comprising a chuck assembly that opens and closes axially relative to each other, a sheath connected to the proximal end of the chuck assembly, two puncture members movably arranged in the chuck assembly, and a pulling member movably arranged in the chuck assembly and the sheath; the chuck assembly is provided with two puncture channels that pass through its distal ends corresponding to the two puncture members, and the pulling member comprises a curved portion that is pre-installed in the chuck assembly and surrounds the two puncture channels; at least one suture is folded in half and arranged in the chuck assembly, and the two free ends of the suture are respectively movably connected to the distal ends of the two puncture members, the puncture member drives the suture into the curved portion, and after the puncture member is withdrawn to be separated from the suture, the suture is locked by the curved portion and driven into the sheath.

[0007] The present invention also provides an interventional tendon chord implantation system, comprising the above-mentioned interventional suture implantation device and guide device, wherein the interventional suture implantation device is movably installed in the guide device, and the clamp assembly extends from the distal end of the guide device, and the distal end of the guide device is provided with at least one adjustable bending section or pre-shaped section.

[0008] In the interventional chord implantation system provided by the present invention, sutures and pulling members are arranged in the clamp assembly and sheath of the interventional suture implantation device. The suture is driven into the curved portion of the pulling member through the puncture member, and the suture is locked by the curved portion. The suture can then be pulled to the surface of the leaflet and out of the sheath by withdrawing the pulling member. The system is easy to use and simple to operate, and reduces the difficulty and risk of the operation. Furthermore, the sheath in the interventional suture implantation device is a flexible structure, and the sheath can be bent accordingly through the guiding device to adapt to the tubular structure of the human body, which causes less damage to the human body and is suitable for remote intervention. 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 mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[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 the mitral valve disease state.

[0012] Figure 3 It is a schematic structural diagram of an interventional tendon chord implantation system provided in the first embodiment of the present invention.

[0013] Figure 4 yes Figure 3 Schematic diagram of the structure of the interventional suture implantation device when the distal end is bent.

[0014] Figure 5 yes Figure 3 Schematic diagram of the structure of the interventional suture implantation device.

[0015] Figure 6 yes Figure 5 Schematic diagram of the structure of the chuck assembly and sheath tube.

[0016] Figure 7 yes Figure 6 A cross-sectional view of a portion of the structure.

[0017] Figure 8 yes Figure 7 An enlarged view of section VIII.

[0018] Fig. 9 yes Figure 6 A schematic diagram of the middle piercing member driving the free end of the suture to pass through the distal end of the clamp assembly.

[0019] Fig.10 yes Fig. 9 Schematic diagram of removing the wire cover of the distal clamp.

[0020] Fig.11 yes Fig.10 Schematic diagram of the bending portion of the pulling member after the piercing member is withdrawn.

[0021] Fig.12 yes Fig.11 A cross-sectional view of a portion of the structure of the clamp assembly when the middle pulling member drives the suture to withdraw.

[0022] Fig.13 yes Figure 6 Schematic diagram of the three-dimensional structure when the chuck assembly is opened.

[0023] Fig.14 yes Fig.13 Magnified view of section XIV in .

[0024] Fig.15 It is a structural schematic diagram of a proximal clamp, a clamping drive rod, a guide rod, a probe and a puncture push rod.

[0025] Fig.16 It is a structural schematic diagram of a distal clamp, a clamping drive rod, a guide rod, a limiter and a pulling member.

[0026] Fig.17 yes Fig.15 Schematic diagram of the probe structure.

[0027] Fig.18 and Fig.19 yes Fig.15 Schematic diagram of the three-dimensional structure of the proximal chuck at different viewing angles.

[0028] Fig. 20 yes Fig.18 A cross-sectional view of the proximal chuck along line AA.

[0029] Fig.21 It is a schematic diagram of the structure of the puncture piece, suture and anti-slip piece.

[0030] Fig. 22 and Fig.23 yes Fig.16 Schematic diagram of the three-dimensional structure of the distal clamp at different viewing angles.

[0031] Figure 24 to Figure 26 They are Fig. 22 A schematic diagram of the three-dimensional structure of the main body block, wire stop cover and connecting block of the distal clamp.

[0032] Fig. 27 It is a structural diagram of the main block and the pulling member.

[0033] Fig.28 yes Fig. 27 Schematic diagram of the three-dimensional structure of the pulling member.

[0034] Fig.29 and Fig.30 It is a schematic structural diagram of other embodiments of the pulling member.

[0035] Figure 31 to Figure 34 It is a schematic structural diagram of different implementations of the rod body of the interventional suture implantation device.

[0036] Fig.35 yes Figure 3 Schematic diagram of the structure of the control handle in .

[0037] Fig.36 yes Figure 6 Schematic diagram of the structure of the clamp assembly clamping the leaflet.

[0038] Fig.37 yes Fig.36 Schematic diagram of the structure in which the clamp assembly clamps the valve leaflet and the puncture piece passes through the distal clamp.

[0039] Fig.38 yes Fig.37 Schematic diagram of the structure after the piercing member is withdrawn.

[0040] Figures 39 to 46 is a schematic diagram of the use process of the interventional chord implantation system provided by the present invention; wherein, Fig.40 yes Fig.39 Magnified view of the XL section.

[0041] Fig.47 It is a schematic structural diagram of the distal clamp of the interventional suture implantation device provided in the second embodiment of the present invention.

[0042] Fig.48 yes Fig.47 Axial cross-sectional view of the distal chuck in FIG.

[0043] Fig.49 yes Fig.47 Schematic diagram of the three-dimensional structure of the protective cover.

[0044] Fig.50 Schematic diagram of a puncture member and suture of an interventional suture implantation device provided in a third embodiment of the present invention.

[0045] Fig.51 yes Fig.50 Illustration of the puncture needle falling into the protective cover. DETAILED DESCRIPTION

[0046] 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.

[0047] 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 operated in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0048] It should be noted that in order to more clearly describe the structure of the interventional suture implantation device and the interventional chord implantation system, the limiting terms "proximal end" and "distal end" described in the specification of the present invention are conventional 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 conventional 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.

[0049] See also Figure 3 and Figure 4 The present invention provides an interventional tendon chord implantation system 1000, which includes an interventional suture implantation device 100 and a guide device 200 for implanting sutures into valve leaflets. The interventional suture implantation device 100 is movably mounted in the guide device 200, and the guide device 200 is used to adjust the distal position of the interventional suture implantation device 100 to deliver it to a predetermined treatment site.

[0050] For details, please refer to Figures 5 to 12The interventional suture implantation device 100 includes a clamp assembly 10 that opens and closes axially relative to each other, a flexible sheath 20 connected to the proximal end of the clamp assembly 10, two puncture members 30 movably arranged in the clamp assembly 10, and a pulling member 40 movably arranged in the clamp assembly 10 and the sheath 20. The clamp assembly 10 is provided with two puncture channels 35 that pass through the distal ends thereof corresponding to the two puncture members 30. The pulling member 40 includes a curved portion 45 pre-installed in the clamp assembly 10 and surrounding the two puncture channels 35. At least one suture 300 is folded in half and arranged in the clamp assembly 10. The two free ends of the suture 300 are respectively movably connected to the distal ends of the two puncture members 30. Thus, when the puncture member 30 drives the free end of the suture 300 to pass through the distal end of the clamp assembly 10, the puncture member 30 and the suture 300 enter the curved portion 45 of the pulling member 40, and when the puncture member 30 is withdrawn to move out of the curved portion 45 of the pulling member 40, the distal end of the clamp assembly 10 blocks the suture 300, and the free end of the suture 300 is separated from the puncture member 30, and the pulling member 40 is withdrawn to lock the curved portion 45 of the pulling member 40 and drive the suture 300 to enter the sheath 20 until the free end of the suture 300 is pulled out of the sheath 20.

[0051] like Figure 3 and Figure 4 As shown, the guide device 200 includes an adjustable curved tube 210 and a bending mechanism 220 disposed at the proximal end of the adjustable curved tube 210, and at least one adjustable curved section is disposed at the distal end of the adjustable curved tube 210. The sheath tube 20 of the interventional suture implantation device 100 is inserted into the adjustable curved tube 210, and the clamp assembly 10 extends from the distal end of the adjustable curved tube 210. The direction of the adjustable curved tube 210 is adjusted by the bending mechanism 220, so that the sheath tube 20 is bent to adjust the position of the clamp assembly 10, thereby delivering the clamp assembly 10 to the predetermined treatment site. It is understandable that the tube body of the guide device 200 can also be a pre-shaped tube, and the distal end of the pre-shaped tube is provided with at least one pre-shaped curved section to reach the predetermined treatment site.

[0052] In this embodiment, after the operator inserts the guide device 200 and the distal end of the interventional suture implantation device 100 into the patient's body by interventional means, the operator adjusts the clamp assembly 10 of the interventional suture implantation device 100 through the guide device 200 outside the patient's body to reach the vicinity of the mitral valve; then the clamp assembly 10 of the interventional suture implantation device 100 is relatively opened and closed to clamp the valve leaflets, and the puncture member 30 is controlled to puncture the valve leaflets and then pass through the distal end of the clamp assembly 10, and the puncture member 30 drives the free end of the suture 300 to pass through the valve leaflets and pass through the distal end of the clamp assembly 10. At this time, the puncture member 30 and the suture 300 enter the curved portion 45 of the pulling member 40 pre-installed in the clamp assembly 10; then the puncture member 30 is controlled to withdraw to move out of the pulling member 40 The curved portion 45 of the movable member 40 and the distal end of the clamp assembly 10 block the suture 300, so that the free end of the suture 300 is separated from the puncture member 30, and the suture 300 is still in the curved portion 45 of the pulling member 40; finally, the pulling member 40 is withdrawn, so that the curved portion 45 of the pulling member 40 is locked and drives the suture 300 into the sheath 20, until the folded part of the suture 300 is attached to the surface of the leaflet, thereby implanting the suture 300 on the leaflet of the mitral valve; the pulling member 40 is continued to be withdrawn until the free end of the suture 300 is pulled out of the sheath 20, and then the operator can fix the free end of the suture 300 on the ventricular wall, papillary muscle or apex, so that the suture 300 replaces the natural chordae tendineae to maintain the tension between the leaflet and the ventricular wall. The interventional chord implantation system 1000 and interventional suture implantation device 100 provided by the present invention are easy to use and simple to operate, reducing the difficulty and risk of surgery; furthermore, the suture 300 is driven by the flexible pulling member 40, and there is no rigid structure in the sheath 20, which is suitable for remote intervention.

[0053] The suture 300 used as the implant is a flexible thread, that is, the suture 300 can be bent arbitrarily without being stretched in the axial direction; the suture 300 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 thread is used.

[0054] Please also read Figures 13 to 16 and Fig.18 , Fig.19The chuck assembly 10 includes a proximal chuck 11 located at the proximal end and connected to the sheath 20, and a distal chuck 13 located at the distal end and connected to the proximal chuck 11 and can be relatively opened and closed, and at least one clamping drive rod 15 arranged between the proximal chuck 11 and the distal chuck 13. The proximal chuck 11 and the distal chuck 13 are connected by the clamping drive rod 15. The clamping drive rod 15 moves axially to drive the distal chuck 13 to open and close relative to the proximal chuck 11, thereby clamping the leaflet. Preferably, in order to avoid the shaking of the chuck assembly 10 and the detachment caused by excessive opening of the chuck, the chuck assembly 10 also includes at least one guide rod 17 arranged between the proximal chuck 11 and the distal chuck 13, and the distal chuck 13 moves axially following the guide rod 17. In this embodiment, the clamping drive rod 15 and the guide rod 17 are both set as one, and the guide rod 17 is arranged parallel to the clamping drive rod 15 and spaced apart.

[0055] Among them, the distal ends of the guide rod 17 and the clamping drive rod 15 are fixedly connected to the distal clamp 13 by welding, bonding or threaded connection, and the proximal ends of the guide rod 17 and the clamping drive rod 15 pass through the proximal clamp 11 and extend from the proximal end of the proximal clamp 11. Accordingly, the proximal clamp 11 is axially provided with a clamping drive rod cavity 111 and a guide rod cavity 112 for the clamping drive rod 15 and the guide rod 17 to pass through.

[0056] The proximal chuck 11 can be made of polymer materials, such as one or more of PP, PE, PET, PTFE, PEBAX, ABS, and PC, or metal materials, such as one or more of stainless steel, iron, copper, nickel titanium, platinum, and gold. It is understood that in other embodiments, the clamping drive rod 15 and the guide rod 17 can also be set to two or other reasonable numbers, or the chuck assembly 10 can also be provided with no guide rod 17.

[0057] Further preferably, a first accommodating cavity 101 extending axially for a certain length is formed at the proximal end of the proximal clamp 11 , a limiting member 19 is arranged in the first accommodating cavity 101 , and the guide rod 17 and / or the clamping drive rod 15 are fixedly connected to the limiting member 19 . When the guide rod 17 and the clamping drive rod 15 move axially, that is, when the proximal chuck 11 and the distal chuck 13 are relatively opened and closed, the limit member 19 can move in the first accommodating chamber 101, and the limit member 19 can increase the guiding stability of the guide rod 17; furthermore, when the guide rod 17 and the clamping drive rod 15 move distally and the distal chuck 13 is opened relative to the proximal chuck 11, the limit member 19 can move distally to the inner bottom wall of the first accommodating chamber 101 to stop, thereby limiting the opening and closing amount of the chuck assembly 10. In this embodiment, the chuck opening and closing amount is preferably 5-15mm, that is to say, the movement range of the limit member 19 in the first accommodating chamber 101 is 5-15mm.

[0058] Please also read Figures 15 to 19 The proximal clamp 11 has a plurality of inner cavities, each of which is connected to the sheath tube 20. Each inner cavity can be integrally formed with the proximal clamp 11, or can be a separate flexible tube body. When a separate flexible tube body is used, each flexible tube body of the proximal clamp 11 extends to the sheath tube 20 (not shown in the figure) and is connected to the flexible tube body in the sheath tube 20 by bonding or other mechanical connection methods.

[0059] Specifically, a guidewire cavity 113 is axially opened at the axis center of the proximal chuck 11 and passes through both ends, and the guidewire cavity 113 is used to insert the guidewire; the proximal chuck 11 is symmetrically opened with two probe cavities 114 passing through both ends on both sides of the guidewire cavity 113, and the probe cavity 114 is used to insert the probe 60 to detect whether a leaflet is clamped between the proximal chuck 11 and the distal chuck 13; the proximal chuck 11 is symmetrically opened with the aforementioned clamping drive rod cavity 111 and guide rod cavity 112 on one side of the guidewire cavity 113, and the clamping drive rod cavity 111 and the guide rod cavity 112 extend from the distal end of the proximal chuck 11 to the proximal end but do not pass through the proximal chuck 11; the proximal end of the proximal chuck 11 corresponds to the clamping drive rod The area of ​​the cavity 111 and the guide rod cavity 112 is provided with the aforementioned first accommodating cavity 101, and the first accommodating cavity 101 extends from the proximal end of the proximal chuck 11 to the distal end to be connected with the clamping drive rod cavity 111 and the guide rod cavity 112. The aforementioned limit member 19 is arranged in the first accommodating cavity 101, and the limit member 19 matches the shape of the first accommodating cavity 101; the proximal end of the clamping drive rod 15 passes through the proximal chuck 11 through the connected clamping drive rod cavity 111 and the first accommodating cavity 101 and extends from the proximal end of the proximal chuck 11, and the proximal end of the guide rod 17 passes through the proximal chuck 11 through the connected guide rod cavity 112 and the first accommodating cavity 101 and extends from the proximal end of the proximal chuck 11.

[0060] In this embodiment, the shape of the limit member 19 and the first accommodating cavity 101 is roughly in the shape of a mountain; the proximal end of the guide rod 17 is fixedly connected to the limit member 19 by welding, gluing or threaded connection; the proximal end of the clamping drive rod 15 passes over the limit member 19 and enters the sheath 20 and extends outside the sheath 20, so that the operator remotely controls the clamping drive rod 15 to move axially to drive the opening and closing of the chuck assembly 10.

[0061] like Fig.15 and Fig.17 As shown, in this embodiment, two probes 60 are slidably and symmetrically arranged in the sheath 20 (not shown in the figure), the proximal end of the probe 60 passes through the sheath 20, and the distal end of the probe 60 can extend from the probe cavity 114 of the proximal clamp 11, and the operator can remotely control the forward and backward movement of the probe 60. After the clamp assembly 10 clamps the leaflet, the probe 60 is pushed to the distal end. When the probe 60 cannot enter the distal clamp 13 due to the obstruction of the leaflet, it means that the leaflet is effectively clamped, and the operator can perform subsequent operations.

[0062] Please also read Figure 7 , Figure 8 , Fig.12 and Figures 18 to 21 The distal end of the proximal clamp 11 is also provided with a second accommodating chamber 102 along the axial direction, and the second accommodating chamber 102 is located on the other side of the guide wire chamber 113 opposite to the clamping drive rod chamber 111 and the guide rod chamber 112; the puncture member 30 and the suture 300 are arranged in the proximal clamp 11, and specifically, the proximal clamp 11 is symmetrically provided with two puncture needle chambers 115 on both sides of the radial direction of the second accommodating chamber 102, and each puncture needle chamber 115 passes through the two ends of the proximal clamp 11 along the axial direction and communicates The proximal end of the proximal clamp 11 is provided with a suture cavity 116 connected to the second accommodation cavity 102 along the axial direction. The two puncture members 30 are respectively accommodated in the two puncture needle cavities 115. The suture 300 is folded in half and accommodated in the second accommodation cavity 102 in parallel with the puncture members 30. The two free ends of the suture 300 are respectively movably connected to the distal ends of the two puncture members 30. The folded part of the suture 300 extends into the proximal inner cavity of the sheath 20 through the suture cavity 116. Fig.12 and Fig.18 As shown, the proximal clamp 11 is also provided with a pulling member channel 47 running through both ends thereof along the axial direction, and the pulling member channel 47 is located between the clamping drive rod cavity 111 and the guide rod cavity 112, so that the bending portion 45 of the pulling member 40 can drive the suture 300 through the pulling member channel 47 into the sheath tube 20 and extend outside the sheath tube 20.

[0063] In other embodiments, the proximal clamp 11 may not have the suture cavity 116 , and the suture 300 may be folded in half multiple times and then completely received in the second receiving cavity 102 , as long as the suture 300 is not entangled.

[0064] like Figure 7 and Figure 8 As shown, in this embodiment, two puncture push rods 32 are slidably inserted into the sheath tube 20, and the proximal ends thereof extend out of the sheath tube 20. The distal ends of the puncture push rods 32 extend into the proximal clamp 11 through the puncture needle cavity 115. The puncture member 30 is a puncture needle connected to the distal end of the puncture push rod 32. The distal end of the puncture needle is provided with a hanging groove, and the suture 300 is hung in the hanging groove, so that the free end of the suture 300 is movably connected to the puncture member 30. When the puncture push rod 32 is remotely controlled to move forward and backward, the puncture member 30 can move forward and backward with it, so that the puncture member 30 drives the two free ends of the suture 300 to move, and the function of the suture 300 passing through the valve leaflet is realized.

[0065] Among them, the distance between the hanging position where the suture 300 contacts the hanging groove and the free end of the suture 300 is greater than 1 / 2 of the outer diameter of the clamp assembly 10, so that when the pulling member 40 drives the suture 300 to move, before the curved portion 45 of the pulling member 40 does not lock the suture 300, the free end of the suture 300 will not be separated from the curved portion 45 of the pulling member 40, thereby avoiding the failure of pulling the wire. The outer diameter of the clamp assembly 10 refers to the diameter of the clamping surface of the distal clamp 13. In addition, the ratio between the depth of the hanging groove along the axial direction of the puncture needle and the diameter of the suture 300 is in the range of (1~3):1, so as to ensure that when the puncture needle moves in the puncture channel 35, the free end of the suture 300 will not be easily separated from the puncture needle, and when the puncture needle brings the suture 300 out of the distal end of the clamp assembly 10 and withdraws the puncture needle, the free end of the suture 300 can be smoothly separated from the puncture needle.

[0066] The piercing member 30 is preferably made of metal materials such as stainless steel, and may also be made of polymer materials with relatively high strength, such as PEEK, PA, etc.

[0067] like Fig.21 As shown, in this embodiment, in order to reduce the risk of the suture 300 tearing the leaflet, an anti-slip member 70 is movably provided on the suture 300. In the process of the pulling member 40 driving the suture 300 to move, the suture 300 drives the anti-slip member 70 to move. When the pulling member 40 drives the suture 300 to move out of the second accommodating cavity 102, the suture 300 can pull the anti-slip member 70 out of the second accommodating cavity 102 until the anti-slip member 70 is in contact with the surface of the leaflet.

[0068] Preferably, the anti-slip member 70 has two through holes spaced apart along its thickness direction, and the two through holes are staggered in the axial direction of the anti-slip member 70, that is, one through hole is located at the distal end of the anti-slip member 70, and the other through hole is located at the proximal end of the anti-slip member 70, and a line connecting the two through holes has a certain angle with the axial direction of the anti-slip member 70, so that the anti-slip member 70 can be placed in the second accommodating cavity 102 parallel to the suture 300, and the two free ends of the suture 300 are respectively passed through the two through holes and movably connected to the distal ends of the two puncture members 30. The anti-slip member 70 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.

[0069] Please also refer to Fig.12 , Figure 22 to Figure 27, the curved portion 45 of the pulling member 40 is arranged in the distal clamp 13. Specifically, in the present embodiment, the distal clamp 13 comprises a main body block 131, a wire stop cover 133 and a connecting block 135 detachably connected to the main body block 131, the main body block 131 is roughly a cylinder with a wedge-shaped notch, and a receiving groove is also provided on the side of the main body block 131 away from the wedge-shaped notch, the wire stop cover 133 is roughly a wedge-shaped body with an arc-shaped groove, and the shape of the connecting block 135 matches the receiving groove of the main body block 131, the wire stop cover 133 and the connecting block 135 are respectively received in the wedge-shaped notch and the receiving groove of the main body block 131, and the three together constitute the distal clamp 13 with a smooth outer surface.

[0070] Among them, the wire blocking cover 133 and the proximal end of the main body block 131 are on the same plane, and the plane forms the clamping surface of the distal clamp 13, which can be seamlessly fitted with the clamping surface of the proximal clamp 11 (i.e., the distal surface of the proximal clamp 11). Preferably, in order to clamp the leaflets more effectively, the two clamping surfaces of the clamp assembly 10 have an anti-slip structure, and the anti-slip structure can be one or more of concave-convex, corrugated, and threaded, preferably corrugated. Further preferably, the two clamping surfaces of the clamp assembly 10 are inclined to the axial arrangement to facilitate the leaflets to slide onto the clamping surface and increase the area of ​​the clamping surface.

[0071] Among them, the main body block 131 and the wire blocking cover 133 are respectively provided with a through hole centered along the axial direction of the distal clamp 13, and the two through holes are connected to form a guide wire channel corresponding to the guide wire cavity 113 of the proximal clamp 11, so as to facilitate the clamp assembly 10 to pass the guide wire.

[0072] The distal clamp 13 corresponds to the puncture member 30 and has a puncture channel 35 axially extending through both ends. Specifically, the main body block 131 has two puncture needle cavities 1315 on the bottom surface 1313 of the wedge-shaped notch on both sides of the guide wire channel of the distal clamp 13, and the wire blocking cover 133 has two puncture needle cavities 1335 correspondingly. The puncture needle cavity 1315 and the puncture needle cavity 1335 are connected to form a puncture channel 35 for the puncture member 30 in the proximal clamp 11 to pass through during puncture.

[0073] The main body block 131 and the connecting block 135 are symmetrically provided with clamping drive rod cavities 1311, 1351 and guide rod cavities 1312, 1352 along the axial direction, and the clamping drive rod cavities 1311, 1351 and the guide rod cavities 1312, 1352 correspond to the clamping drive rod cavities 111 and the guide rod cavities 112 of the proximal clamp 11, respectively, for passing the clamping drive rod 15 and the guide rod 17. Specifically, the distal ends of the guide rod 17 and the clamping drive rod 15 pass through the main body block 131 and are fixedly connected to the connecting block 135 by welding, bonding or threaded connection. In other embodiments, the main body block 131 and the connecting block 135 can be integrated, and the guide rod 17 and the clamping drive rod 15 are fixedly connected to the main body block 131 by welding, bonding or threaded connection.

[0074] The main body block 131, the wire stopper 133 and the connecting block 135 can be made of polymer materials, such as PP, PE, PET, PTFE, PEBAX, ABS, PC, POM, PA, etc., or metal materials, such as stainless steel, iron, copper, nickel titanium, platinum, gold, aluminum alloy, etc., or a combination of multiple materials. In this embodiment, the main body block 131 and the connecting block 135 are made of ABS, and the wire stopper 133 is made of stainless steel.

[0075] Please also read Fig.12 and Fig. 27 , the curved portion 45 of the pulling member 40 is disposed in the distal clamp 13. Specifically, there is an arc-shaped gap between the inner wall of the wedge-shaped notch of the main body block 131 and the inner wall of the arc-shaped groove of the thread blocking cover 133, and the arc-shaped gap forms a third accommodating cavity 103 connected to the pulling member channel 47, and the curved portion 45 of the pulling member 40 is disposed in the third accommodating cavity 103. When the pulling member 40 is withdrawn, the curved portion 45 of the pulling member 40 can drive the free end of the suture 300 located in the curved portion 45 to move out of the third accommodating cavity 103, and enter the sheath tube 20 through the pulling member channel 47 until it extends outside the sheath tube 20. Specifically, the puller 40 also includes a straight portion 43 that penetrates the sheath 20 (not shown in the figure), the proximal end of which extends outside the sheath 20, and the distal end of the straight portion 43 extends into the proximal clamp 11 through the puller channel 47. The curved portion 45 of the puller 40 is connected to the straight portion 43. When the operator withdraws the straight portion 43 of the puller 40 toward the proximal end, the curved portion 45 of the puller 40 withdraws accordingly. The curved portion 45 of the puller 40 may include at least one slipknot ring, U-shaped ring or closed ring structure. Fig.28 As shown, in this embodiment, the curved portion 45 and the straight portion 43 of the pulling member 40 are both flexible wires, that is, the pulling member 40 as a whole is a flexible wire, and a slipknot ring is provided at the distal end of the pulling member 40 to form the curved portion 45 .

[0076] In other embodiments, the pulling member 40 may be a folded flexible wire, and the folded portion of the pulling member 40 forms a curved portion 45b of a U-shaped ring structure, such as Fig.29 shown.

[0077] In other embodiments, the pulling member 40 may also be a combination of a flexible wire and a flexible rod or a flexible tube. For example, the curved portion 45c of the pulling member 40 is a flexible wire, the straight portion 43c of the pulling member 40 is a flexible tube or a flexible rod, and the curved portion 45c and the straight portion 43c are connected by a joint 44. Fig.30 As shown, the smoothness of pulling is improved. Of course, the curved portion 45c and the straight portion 43c can also be directly connected without the joint 44.

[0078] The flexible wire of the puller 40 can be made of a polymer material, for example, a single or multiple strands of one or more materials selected from PP, PE, PET, PTFE, e-PTFE, and PEBAX; it can also be made of a flexible metal material, for example, a single or multiple strands of one or more mixed materials selected from stainless steel, copper, iron, and nickel-titanium. The flexible rod or flexible rod of the straight portion of the puller 40 can be made of a polymer material such as PI, PEBAX, PET, PA, and PEEK, or can be made of a flexible metal such as nickel-titanium alloy and stainless steel. The materials of the puller 40 and the suture 300 can be the same or different. Preferably, the puller 40 is stronger than the suture 300 to facilitate pulling and locking the suture 300.

[0079] like Fig. 27 As shown, when the curved portion 45 of the pulling member 40 is disposed in the third accommodating chamber 103, the curved portion 45 of the pulling member 40 is disposed around the puncture channel 35 (i.e., the two puncture needle cavities 1315) and the axial through hole of the main body block 131, thereby, the puncture member 30 drives the suture 300 to penetrate into the puncture channel 35, and the puncture member 30 and the suture 300 enter the curved portion 45. When the puncture member 30 is withdrawn to move out of the curved portion 45, the suture 300 remains in the curved portion 45. The withdrawn pulling member 40 can drive the suture 300 to withdraw together through the curved portion 45 and enter the sheath tube 20 through the pulling member channel 47 until it extends outside the sheath tube 20. Preferably, in this embodiment, the contact surface in the third accommodating chamber 103 that fits with the bent portion 45 of the pulling member 40 (i.e., the bottom surface 1313 of the wedge-shaped notch of the main block 131) is tilted, and the connection between the bent portion 45 of the pulling member 40 and the remaining portion of the pulling member (i.e., the straight portion 43) is biased toward the proximal end of the distal clamp 13, so that the bent portion 45 of the pulling member 40 forms an acute angle with the axial direction of the distal clamp 13, which is conducive to the bent portion 45 of the pulling member 40 to quickly move out of the third accommodating chamber 103 and enter the pulling member channel 47 of the proximal clamp 11. Furthermore, in order to prevent the bending portion 45 of the pulling member 40 from shifting so that the puncture member 30 and the suture 300 cannot puncture into the bending portion 45, a limiting groove 1317 is opened on the bottom surface 1313 of the main body block 131, and the limiting groove 1317 surrounds the puncture channel 35. The bending portion 45 of the pulling member 40 is accommodated in the limiting groove 1317. Preferably, the bending portion 45 of the pulling member 40 is assembled in the limiting groove 1317 with a small interference fit to ensure that the bending portion 45 will not easily disengage from the limiting groove 1317 during the opening and closing process of the clamp, and when the pulling member 40 is withdrawn, the bending portion 45 can smoothly disengage from the limiting groove 1317 and enter the pulling member channel 47 of the proximal clamp 11.

[0080] It can be understood that in this embodiment, the curved portion 45 of the pulling member 40 is a slipknot loop, and when the operator pulls the pulling member 40 and withdraws the curved portion 45, the slipknot loop will gradually tighten; furthermore, when the curved portion 45 drives the suture 300 to enter the pulling member channel 47, the distal entrance of the pulling member channel 47 will also play a certain tightening role on the slipknot loop. Preferably, as Fig. 20 As shown, in this embodiment, a locking cavity 475 is opened at the distal end of the pulling member channel 47, and the diameter of the locking cavity 475 gradually decreases from the distal end to the proximal end. When the curved portion 45 of the pulling member 40 drives the suture 300 through the locking cavity 475 and enters the pulling member channel 47, the curved portion 45 of the pulling member 40 gradually contracts to lock the suture 300, which is beneficial to enhance the connection strength between the suture 300 and the pulling member 40, and ensure that the suture 300 will not be separated from the curved portion 45 during the withdrawal of the pulling member 40.

[0081] Among them, the diameter of the pulling member channel 47 is equal to or greater than the minimum diameter of the locking cavity 475. Preferably, the minimum diameter of the locking cavity 475 is smaller than the diameter of the bending portion 45 of the pulling member 40 after locking the suture 300. When the bending portion 45 of the pulling member 40 drives the suture 300 through the narrowest part of the locking cavity 475, it needs to undergo slight elastic deformation to pass through, thereby ensuring that the pulling member 40 and the suture 300 are locked with each other and will not detach.

[0082] See also Figure 3 , the chuck assembly 10 is fixed to the distal end of the sheath 20. Specifically, a connector 25 is provided at the distal end of the sheath 20 for connecting to the proximal chuck 11 of the chuck assembly 10. The sheath 20 is a flexible tube body with a certain axial length. The sheath 20 is provided with a plurality of mutually separated inner cavities along the axial direction. The sheath 20 can adopt an integrally formed multi-lumen tube, or the outer tube and the inner tube can be fixed together to form a sheath 20 of an integral structure. In the present embodiment, the sheath 20 includes a hollow flexible outer tube, through which a plurality of flexible inner tubes are passed, the central flexible inner tube serves as a guide wire cavity, and the remaining flexible inner tubes are respectively passed with components such as a pulling member 40, a suture 300, a puncture push rod 32, and a clamping drive rod 15. The sheath 20 can be made of biocompatible polymer materials, such as polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or polyurethane PU, or made of metal materials, such as stainless steel or nickel-titanium alloy.

[0083] It is understandable that since both the chuck assembly 10 and the sheath 20 need to reach the predetermined treatment site through remote intervention, the rods used in the sheath 20, the proximal chuck 11 and the distal chuck 13 (for example, the clamping drive rod 15, the guide rod 17, the puncture push rod 32, the probe 60, etc.) need to have both flexibility and rigidity. Preferably, the two ends of the flexible tube or 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.

[0084] See also Figure 31 to Figure 34 Various embodiments of the aforementioned rod body are shown. Fig.31 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.32 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 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 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 stainless steel tube or stainless steel rod at the far end has both rigidity and surface smoothness to ensure smooth and reliable guidance. The flexibility of the steel cable core in the middle section meets the bending requirements, and the stainless steel tube or stainless steel rod at the near end ensures sufficient rigidity and support. Fig.33 and Fig.34 As shown, in another embodiment, the two ends are steel pipes, and nickel-titanium wires are passed through the middle of the steel pipes, and the nickel-titanium wires are welded or mechanically compressed to the steel pipes at the two ends; a spring is provided between the two steel pipes, and the spring is squeezed between the steel pipes, so that the two ends can maintain a certain rigidity, and the middle section has good flexibility and rigidity. In this embodiment, the distal end of the clamping drive rod 15, the guide rod 17 and the probe 60 are all made of metal materials with higher hardness, such as 304 stainless steel, 316 stainless steel or nickel-titanium; they can also be made of polymer materials with higher strength, such as PEEK, POM, PA; the proximal end of the clamping drive rod 15 and the guide rod 17 inserted into the sheath tube 20 is a flexible rod body or tube body, such as a flexible metal cutting tube, and the proximal end and the distal end are welded. The puncture push rod 32 is inserted into the sheath tube 20 as a whole, so the whole is a flexible rod body or tube body.

[0085] Please also read Figure 3 and Fig.35 In order to facilitate remote operation outside the body, the interventional suture implantation device 100 is also provided with a control handle 50.

[0086] Specifically, the control handle 50 is arranged at the proximal end of the sheath tube 20, and is used to drive the chuck assembly 10 to open and close relative to each other, drive the puncture member 30 to puncture distally and withdraw proximally, drive the pull member 40 to withdraw, and drive the movement of the probe 60. The control handle 50 includes a housing 51 and a drive assembly, the drive assembly is installed in the housing 51, and the probe display panel 52 is arranged on the housing 51 to indicate the position of the probe 60 to the operator. The housing 51 is connected to the proximal end of the sheath tube 20 through a rotating wheel 53, and the connection method can adopt mechanical connection methods such as bonding, injection molding connection, and threaded connection. The rotating wheel 53 can drive the sheath tube 20 and the internal components of the sheath tube 20 to rotate. Through the overall movement of the control handle 50, the sheath tube 20 can be driven to advance to the distal end or withdraw to the proximal end, thereby driving the movement of the interventional suture implantation device 100, so that the chuck assembly 10 can smoothly reach the specified position.

[0087] The drive assembly includes a clamping drive 54 for controlling the opening and closing of the clamp assembly 10, a probe drive 55 for controlling the movement of the probe 60, a puncture drive 56 for controlling the movement of the puncture member 30, and a pull-wire drive 57 for controlling the pull member 40. The clamping drive 54 is connected to the distal clamp 13 through the proximal end of the clamping drive rod 15. The probe drive 55 is connected to the proximal end of the probe 60, and its movement can drive the two probes 60 to move forward or backward for a certain distance. The puncture drive 56 is connected to the proximal end of the puncture push rod 32 to drive the puncture member 30 to move forward and backward to achieve the function of puncturing the valve leaflet. The pull-wire drive 57 is connected to the proximal end of the pull member 40. When the puncture member 30 is withdrawn, the pull member 40 can be driven to move through the pull-wire drive 57, thereby driving the suture 300 from the clamp assembly 10 to the tail end of the control handle 50 through its curved portion 45.

[0088] All components of the control handle 50 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. In this embodiment, ABS and PC are used.

[0089] Please also read Figures 5 to 8 , Fig.12 and Figure 36 to Figure 38 , showing the process of the clamp assembly 10 opening and clamping the leaflet, the puncture member 30 puncturing the leaflet and withdrawing, and the pulling member 40 pulling back the suture 300.

[0090] Figures 5 to 8The initial state of the clamp assembly 10 is shown, at this time, the proximal clamp 11 and the distal clamp 13 are closed, and the clamp assembly 10 is driven to rotate or move forward and backward as a whole through the control handle 50. The puncture member 30, the anti-slip member 70 and the suture 300 are pre-installed in the proximal clamp 11, and the two free ends of the suture 300 are respectively overlapped with the distal hanging grooves of the two puncture members 30. The curved portion 45 at the distal end of the pull member 40 is pre-installed in the distal clamp 13, and the curved portion 45 is arranged around the outside of the puncture channel 35, and the proximal end of the pull member 40 extends from the proximal clamp 11 and the sheath 20 to the outside of the sheath 20 in sequence and is connected to the control handle 50.

[0091] Fig.36 The clamp assembly 10 is shown closed until the leaflet is stably clamped between the proximal clamp 11 and the distal clamp 13 .

[0092] Fig.37 It is shown that the puncture drive 56 in the control handle 50 drives the puncture member 30 to carry the two free ends of the suture 300 overlapped with it through the leaflet, so that the suture 300 is implanted into the leaflet and passes through the middle of the curved portion 45 of the pulling member 40 until the two free ends of the suture 300 extend out of the distal clamp 13.

[0093] Fig.38 The puncture drive member 56 is shown to be retracted to drive the puncture member 30 to retract. Since the free end of the suture 300 and the wire hanging groove of the puncture member 30 are only matched through the overlapping gap, when the puncture member 30 is retracted, the free end of the suture 300 is blocked by the end surface of the distal clamp 13 and the influence of its own gravity and automatically detaches from the puncture member 30. The free end of the suture 300 stays outside the distal clamp 13. At this time, the suture 300 is still in the curved portion 45 of the pulling member 40.

[0094] Fig.12 It is shown that the pulling member 40 is retracted toward the proximal end by the pull wire driving member 57 on the control handle 50, and the curved portion 45 of the pulling member 40 gradually tightens the suture 300 located inside it during the movement, thereby driving the suture 300 to move toward the proximal end with it until the suture 300 is pulled out of the end of the control handle 20 through the sheath 20.

[0095] Please also read Figure 36 to Figure 46 The following uses the interventional mitral valve artificial chord repair surgery as an example to illustrate the use of the interventional chord implantation system 1000 provided by the present invention. The surgical route is: via the femoral vein - inferior vena cava - right atrium - atrial septum - left atrium - mitral valve.

[0096] Step 1: Puncture the femoral vein, insert the guide wire into the right atrium, then puncture the oval fossa of the atrial septum, and send the guide wire from the right atrium to the left atrium and reach the vicinity of the mitral valve, thereby establishing a track from outside the body to inside the body;

[0097] Step 2: If Fig.39 and Fig.40 As shown, the sheath tube 20 of the interventional chord implantation device 100 is inserted into the adjustable curved tube 210 of the guide device 200, and is passed along the guide wire to the left atrium, and the distal end of the interventional chord implantation device 100 is continuously advanced and the position is adjusted until the clamp assembly 10 reaches the vicinity of the mitral valve and is located between the anterior leaflet and the posterior leaflet;

[0098] Step 3: If Fig.41 As shown, the clamping driving member 54 on the control handle 50 is operated to open the distal clamp 13 and the proximal clamp 11, and the opening and closing distance of the clamp assembly 10 is adjusted to adjust the leaflet to the leaflet accommodating space between the distal clamp 13 and the proximal clamp 11;

[0099] Step 4: If Fig.36 As shown, the clamping driving member 54 on the control handle 50 is operated again to retract the distal clamp 13 until the leaflet is stably clamped between the proximal clamp 11 and the distal clamp 13;

[0100] Step 5: Control the probe 60 to move distally by the probe driving member 55 on the control handle 50. If the probe 60 clamps the valve leaflet, it will be blocked by the valve leaflet and cannot continue to move distally. At this time, the relative positions of the puncture member 30, the suture 300, the pulling member 40, the anti-slip member 70 and the valve leaflet are as shown in FIG. Fig.42 shown.

[0101] Step 6: If Fig.37 As shown, the puncture drive member 56 on the control handle 50 is operated to drive the puncture member 30 and the suture 300 overlapped in the distal hanging groove of the puncture member 30 to pass through the valve leaflet and pass out of the distal clamp 13. At this time, the relative positions of the puncture member 30, the anti-slip member 70, the suture 300, the pulling member 40 and the valve leaflet are as shown in FIG. Fig.43 shown.

[0102] Step 7: If Fig.38 As shown, the puncture drive member 56 on the control handle 50 is operated again to drive the puncture member 30 to withdraw, and the free end of the suture 300 is blocked by the outer end surface of the distal clamp 13 and is separated from the puncture member 30. Therefore, the free end of the suture 300 remains at the outer end of the distal clamp 13 and passes through the curved portion 445 at the distal end of the pulling member 40. At this time, after the puncture member 30 is withdrawn, only the suture 300 passes through the leaflet and the curved portion 45 of the pulling member 40. The relative positions of the puncture member 30, the pulling member 40, the anti-slip member 70, the suture 300 and the leaflet are shown in FIG. Fig.44 shown.

[0103] Step 8: Fig.45As shown, the pull wire driving member 57 on the control handle 50 is used to drive the pulling member 40 to retract, thereby driving the suture 300 in the curved portion 45 of the pulling member 40 to retract, and the suture 300 moves to the outer end of the control handle 50, and the anti-slip member 70 is driven to the surface of the leaflet.

[0104] Step 9: Determine the appropriate length of the artificial chord based on the medical image, and cut the suture 300 pulled outside the body as needed.

[0105] Step 10: If Fig.46 As shown, the interventional suture implantation device 100 and the guide device 200 are withdrawn from the patient's body to complete the operation. The anti-slip member 70 and the suture 300 remain in the body. One end of the suture 300 is fixed to the valve leaflet in a U shape through the anti-slip member 70, and the other end of the suture 300 is fixed to the ventricular wall or the papillary muscle to replace the diseased chordae tendineae and maintain the tension between the valve leaflet and the ventricular wall to complete the operation.

[0106] Figure 47 to Figure 49 The second embodiment of the present invention is shown. Compared with the first embodiment, a protective cover 137 is provided at the distal end of the clamp assembly 10. The protective cover 137 is used to accommodate the puncture needle passing through the distal end of the clamp assembly 10 and to limit the puncture position of the puncture needle. Specifically, in the present embodiment, a groove 1371 is provided on the side of the protective cover 137 facing the distal clamp 13, and the protective cover 137 is only provided with a through hole 1373 for the guide wire to pass through in the groove 1371. The protective cover 137 is fixedly connected to the main block 131 of the distal clamp 13 by snapping or gluing. The protective cover 137 and the main block 131 are surrounded by a receiving groove 104. When the puncture needle carries suture for puncture, the puncture needle is always closed in the clamp and the receiving groove 104. Therefore, the protective cover 137 can protect the puncture needle and avoid the risk of the puncture needle stabbing the heart during the puncture process. Furthermore, since the protective cover 137 is not provided with a puncture channel, the puncture needle cannot pass through the protective cover 137, thereby limiting the stroke of the puncture needle.

[0107] Figure 50 to Figure 51The third embodiment of the present invention is shown. Compared with the second embodiment, the puncture member 30 includes a connecting rod 301 connected to the distal end of the puncture push rod 32 and a puncture needle 303 detachably connected to the distal end of the connecting rod 301. The puncture needle 303 is provided with a through threading hole 3031 in a substantially radial direction. The free end of the suture 300 passes through the threading hole 3031 for a distance, and the suture 300 and the puncture needle 303 are in clearance. The puncture push rod 32 is pushed to drive the puncture needle 303 and the suture 300 to pass through the leaflet together. When the puncture push rod 32 is withdrawn, the puncture needle 303 is separated from the connecting rod 301 due to gravity, and the suture 300 and the puncture needle 303 remain in the receiving groove 104 formed by the protective cover 137 and the main body block 131. When the pulling member 40 drives the suture 300 to move, the suture 300 is gradually withdrawn from the threading hole 3031 of the puncture needle 303, so that the puncture needle 303 remains in the receiving groove 104. With this structure, the suture 300 is more easily separated from the puncture member 30, reducing the risk of the puncture member failing to separate from the suture 300 when withdrawing and driving the suture 300 to withdraw.

[0108] 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. An interventional suture implantation device, characterized in that: It comprises a chuck assembly that opens and closes relatively in the axial direction, a sheath connected to the proximal end of the chuck assembly, two puncture members movably arranged in the chuck assembly, and a pulling member movably arranged in the chuck assembly and the sheath; The clamp assembly comprises a proximal clamp and a distal clamp, the two puncture members are arranged in the proximal clamp, the distal clamp has two puncture channels axially extending through the two ends corresponding to the two puncture members, the proximal clamp has a pulling member channel axially extending through the two ends, the pulling member comprises a curved portion pre-installed in the distal clamp and surrounding the two puncture channels, and the curved portion is made of a flexible material; At least one suture is folded in half and arranged in the proximal clamp, and the two free ends of the suture are respectively movably connected to the distal ends of the two puncture members, and the puncture members drive the suture to penetrate the puncture channel and enter the curved portion. After the puncture members are withdrawn until separated from the suture, the pulling member is withdrawn to lock the curved portion and drive the suture through the pulling member channel into the sheath tube until the free end of the suture extends outside the body.

2. The interventional suture implantation device according to claim 1, characterized in that: It also includes a puncture push rod inserted into the sheath tube, and the puncture member includes a puncture needle connected to the distal end of the puncture push rod. The distal end of the puncture needle is provided with a hanging groove for hanging the suture.

3. The interventional suture implantation device according to claim 2, characterized in that: The distance between the hanging position where the suture contacts the hanging groove and the free end of the suture is greater than 1 / 2 of the outer diameter of the clamp assembly; the ratio between the depth of the hanging groove along the axial direction of the puncture needle and the diameter of the suture is in the range of (1 to 3):

1.

4. The interventional suture implantation device according to claim 1, characterized in that: It also includes a puncture push rod inserted into the sheath, the puncture component includes a connecting rod connected to the distal end of the puncture push rod and a puncture needle detachably connected to the distal end of the connecting rod, the puncture needle has a through threading hole opened in a substantially radial direction, and the free end of the suture passes through the threading hole.

5. The interventional suture implantation device according to claim 4, characterized in that: The puncture member drives the free end of the suture to pass through the distal end of the clamp assembly, and the puncture needle completely extends out of the clamp assembly. When the puncture member is withdrawn, the puncture needle is separated from the connecting rod.

6. The interventional suture implantation device according to any one of claims 2 to 5, characterized in that: The sheath tube and the puncture push rod are both flexible rod bodies or tube bodies.

7. The interventional suture implantation device according to any one of claims 2 to 5, characterized in that: A protective cover is provided at the distal end of the clamp assembly, and the protective cover is used to accommodate the puncture needle passing through the distal end of the clamp assembly and is used for puncture limiting of the puncture needle.

8. The interventional suture implantation device according to claim 1, characterized in that: The pulling member further comprises a straight portion penetrating the sheath tube, the distal end of the straight portion of the pulling member extends into the clamp assembly, and the curved portion of the pulling member is connected to the straight portion of the pulling member.

9. The interventional suture implantation device according to claim 8, characterized in that: The curved portion of the pulling member at least includes a slipknot ring, a U-shaped ring or a closed ring.

10. The interventional suture implantation device according to claim 8, characterized in that: The straight portion of the pulling member is made of a flexible or rigid material.

11. The interventional suture implantation device according to claim 1, characterized in that: A locking cavity is provided at the distal end of the pulling member channel, and the diameter of the locking cavity gradually decreases from the distal end to the proximal end. When the curved portion of the pulling member drives the suture through the locking cavity, the curved portion of the pulling member gradually contracts to lock the suture.

12. The interventional suture implantation device according to claim 11, characterized in that: The diameter of the pulling member channel is equal to or greater than the minimum diameter of the locking cavity; the minimum diameter of the locking cavity is smaller than the diameter of the curved portion of the pulling member after locking the suture.

13. The interventional suture implantation device according to claim 1, characterized in that: The clamp assembly further includes at least one 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.

14. The interventional suture implantation device according to claim 13, characterized in that: The clamp assembly further includes at least one guide rod disposed between the proximal clamp and the distal clamp, wherein the guide rod is parallel and spaced apart from the clamping drive rod.

15. The interventional suture implantation device according to claim 14, characterized in that: The clamping drive rod and the guide rod are both flexible rod bodies or tube bodies that are inserted into the sheath tube.

16. The interventional suture implantation device according to claim 14, characterized in that: The distal ends of the guide rod and the clamping drive rod are fixedly connected to the distal clamp, the proximal end of the proximal clamp is provided with a limiting piece, and the guide rod and / or the clamping drive rod are fixedly connected to the limiting piece.

17. The interventional suture implantation device according to claim 1, characterized in that: The distal clamp comprises a main body block and a wire stop cover detachably connected to the main body block, and the bent portion of the pulling member is obliquely arranged between the main body block and the wire stop cover, so that the bent portion of the pulling member forms an acute angle with the axial direction of the distal clamp.

18. The interventional suture implantation device according to claim 1, characterized in that: An anti-slip part is movably mounted on the suture, and the anti-slip part is accommodated in the chuck assembly. The anti-slip part has two through holes spaced apart along its thickness direction, and an angle is formed between a line connecting the two through holes and the axial direction of the anti-slip part. The two free ends of the suture are movably connected to the distal ends of the two piercing members after respectively passing through the two through holes.

19. An interventional chord implantation system, characterized in that: It comprises an interventional suture implantation device as described in any one of claims 1 to 18, and also comprises a guide device, wherein the interventional suture implantation device is movably installed in the guide device, the clamp assembly extends from the distal end of the guide device, and the distal end of the guide device is provided with at least one adjustable bend section or pre-shaped section.

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