WO2021109616A1 - Valve suture device and valve repair suture device - Google Patents

Valve suture device and valve repair suture device Download PDF

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Publication number
WO2021109616A1
WO2021109616A1 PCT/CN2020/109627 CN2020109627W WO2021109616A1 WO 2021109616 A1 WO2021109616 A1 WO 2021109616A1 CN 2020109627 W CN2020109627 W CN 2020109627W WO 2021109616 A1 WO2021109616 A1 WO 2021109616A1
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WO
WIPO (PCT)
Prior art keywords
chuck
valve
distal
proximal
push tube
Prior art date
Application number
PCT/CN2020/109627
Other languages
French (fr)
Chinese (zh)
Inventor
李阳
黄广念
梁华光
张庭超
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201922178565.XU external-priority patent/CN211834543U/en
Priority claimed from CN201911245049.2A external-priority patent/CN112914635A/en
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2021109616A1 publication Critical patent/WO2021109616A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a valve suture device and a valve repair suture device.
  • the left atrium (LA as shown in Figure 1) and the left ventricle (LV as shown in Figure 1) are separated by the mitral valve (MV as shown in Figure 1), and the right atrium (as shown in Figure 1) Show RA) and the right ventricle (RV shown in Figure 1) are separated by the tricuspid valve (TV shown in Figure 1).
  • the tricuspid valve and the mitral valve allow blood to flow from the atrium into the ventricle only, not back flow.
  • Normal and healthy mitral and tricuspid valves have multiple chordae (CT as shown in Figure 1). Take the mitral valve as an example.
  • the valve of the mitral valve is divided into anterior and posterior leaflets.
  • the left ventricle When the left ventricle is in a diastolic state, the two are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contracted state, the tendon The cord is stretched to ensure that the valve will not be rushed to the atrium side by blood flow, and the front and back leaflets are closed well, thereby ensuring that blood flows from the left ventricle to the aorta through the aortic valve. If the chordae tendineae is diseased or ruptured, when the left ventricle is in a contracted state, the mitral valve cannot return to the closed state as in the normal state, and the momentum of the blood flow will further cause the valve to fall into the left atrium, causing blood reflux.
  • Mitral valve chordae rupture is typically manifested as acute severe wheezing, dyspnea and other left heart failure, pulmonary edema, and some are progressive chronic heart failure.
  • a minimally invasive interventional artificial chordal instrument in which the artificial chord is connected to the sleeve and placed in the distal chuck, the instrument is advanced through the apex to the left ventricle and the left atrium, the distal chuck and the proximal clip
  • the distal chuck When the valve is clamped by the head, the distal chuck is located on the atrium side, and the proximal chuck is located on the ventricle side.
  • the needle protrudes from the proximal chuck through the valve and is fixedly connected to the artificial chords in the distal chuck. The needle then withdraws and drives the artificial chord and gasket to withdraw through the valve in turn.
  • the gasket will touch the surface of the valve near the atrium side, that is, the gasket is located on the atrium side, the artificial chordae extends on the ventricular side, and finally the end of the artificial chordae away from the valve is fixed to the ventricular wall or papillary muscle.
  • the device of this structure is allowed to enter the atrium and ventricle through the inferior vena cava or superior vena cava in turn.
  • the distal clamp is located in the ventricle
  • the proximal chuck is located on the atrial side
  • the final gasket is located on the ventricle side.
  • the artificial chordae passes through the atrial side of the valve and extends along the atrial side. The end of the artificial chordae is far away from the valve and away from the ventricular wall or papillary muscle, so it cannot be implemented. Artificial tendon implantation cannot achieve the function of valve repair.
  • the present invention provides a valve suture device and a valve repair suture device for implanting artificial chordae.
  • the artificial chordae is moved from the side of the valve close to the ventricle. Pass out and extend along the side of the ventricle to realize the implantation of artificial chordae.
  • the present application provides a valve suture device for implanting artificial chordae, including a clamping assembly, a needle assembly, and a guide;
  • the clamping assembly includes a proximal chuck, a chuck push tube, and The distal chuck, the chuck push tube is movably inserted in the proximal chuck and fixedly connected to the distal chuck, and the chuck push tube is used to drive the distal chuck relative to the proximal chuck.
  • the end chuck moves to clamp or relax the valve; the pin assembly is movably installed in the proximal chuck and connected to the artificial chord which is contained in the proximal chuck, and the lead
  • the device is movably installed in the chuck push tube and the distal chuck, and the needle assembly is used to pull the artificial chordae from the atrium side to the ventricle side to puncture the valve and penetrate the lead guide.
  • the thread guide is used to bind the artificial chordae and pull the artificial chordae into the chuck push tube and withdraw in the proximal direction, so that the part of the artificial chordae is confined to the valve near the atrium One side.
  • the present application also provides a valve repair suture device, which includes the valve suture device described above and an operating body.
  • the operating body is provided with a needle control element, a lead control element, and a chuck control element.
  • the needle control member is connected with the proximal end of the pin assembly to control the movement of the pin assembly in the axial direction
  • the lead control member is connected with the proximal end of the introducer to control the movement of the introducer in the axial direction
  • the chuck control member is connected with the proximal end of the chuck push tube to control the chuck push tube to move in the axial direction.
  • the needle assembly since the needle assembly is movably inserted in the proximal chuck and connected to the artificial chords contained in the proximal chuck, the thread guide is movably installed in the chuck In the push tube and the distal chuck, the needle can pull the artificial chordae from the atrium side to the ventricular side and then pass through the introducer.
  • the introducer can bind the artificial chordae and pull the artificial chord into the chuck. Withdraw in the proximal direction, so that a part of the artificial chordae can be confined on the side of the valve close to the atrium, and the artificial chordae can pass through from the ventricle side and extend along the ventricular side.
  • the artificial tendon can be anchored later by anchoring.
  • the part of the cord away from the valve is fixed to the ventricular wall or papillary muscle on the side of the ventricle, so as to realize the implantation of the artificial chordae and the repair of the heart valve through the catheter.
  • Figure 1 is a schematic diagram of the heart structure.
  • Fig. 2 is a three-dimensional assembly schematic diagram of the valve repair suture device provided by the first embodiment of the application.
  • Fig. 3 is a cross-sectional view of the valve suture device of the valve repair suture device shown in Fig. 2.
  • Fig. 4 is a schematic diagram of the valve suture device in a clamped state of the valve repair suture device shown in Fig. 2.
  • Fig. 5 is a three-dimensional cross-sectional view of the valve suture device of the valve repair suture device shown in Fig. 2 in a clamped state.
  • Fig. 6 is a schematic diagram of the valve suture device of the valve repair suture device shown in Fig. 2 in a punctured state with part of the structure removed.
  • FIG. 7 is a partial enlarged schematic diagram of the area I shown in FIG. 6.
  • Fig. 8 is a cross-sectional view of the valve suture device of the valve repair suture device shown in Fig. 2 in a punctured state.
  • Fig. 9 is a three-dimensional exploded schematic diagram of the valve suture device shown in Fig. 3.
  • FIG. 10 is a schematic diagram of the structure of the distal chuck cap of the valve suture device shown in FIG. 3.
  • FIG. 11 is a three-dimensional assembly schematic diagram of the thread guide and the lead control component shown in FIG. 3.
  • Fig. 12 is a schematic diagram of the distal chuck body of the valve suture device shown in Fig. 3 and the lead guide being assembled together.
  • Fig. 13 is a three-dimensional schematic diagram of the assembly of the needle assembly and the artificial chord of the valve suture device shown in Fig. 3 together.
  • Fig. 14 is an axial cross-sectional view of the needle assembly of the valve suture device shown in Fig. 3.
  • Figure 15 is a cross-sectional view perpendicular to the axial direction of the pin assembly.
  • Fig. 16 is a schematic diagram showing the assembly of the needle assembly and the artificial chord of the valve suture device shown in Fig. 6 together.
  • Fig. 17 is a schematic diagram of the pin assembly and artificial chord of Fig. 16 from another perspective.
  • Fig. 18 is a schematic diagram of the artificial chord and the pin assembled together according to the first embodiment.
  • Fig. 19 is a cross-sectional view of the sheath of the valve suture device shown in Fig. 3.
  • Fig. 20 is a schematic diagram of an application scenario of the valve repair suture device shown in Fig. 2 for treating a tricuspid valve.
  • Fig. 21 is a schematic diagram of an application scenario of the valve repair suture device shown in Fig. 2 for treating the mitral valve.
  • Fig. 22 is a schematic diagram of the valve repair suture device shown in Fig. 2 before clamping the valve.
  • Fig. 23 is a schematic diagram of the valve repair suture device shown in Fig. 2 when it is in a puncture state.
  • Fig. 24 is a three-dimensional schematic diagram of the valve repair suture device shown in Fig. 2 when it is in a puncture state.
  • Fig. 25 is a schematic diagram when the introducer of the valve repair suture device shown in Fig. 2 starts to withdraw.
  • Fig. 26 is a three-dimensional schematic diagram when the introducer of the valve repair suture device shown in Fig. 2 starts to be withdrawn.
  • Fig. 27 is a schematic diagram after the introducer of the valve repair suture device shown in Fig. 2 is withdrawn.
  • Fig. 28 is a three-dimensional schematic diagram of the valve repair suture device shown in Fig. 2 after the introducer is withdrawn.
  • Fig. 29 is a schematic diagram showing the state of the artificial chordae after the introducer of the valve repair suture device shown in Fig. 2 is withdrawn.
  • FIG. 30 is a schematic diagram of the effect of the valve repair suture device provided by an embodiment of the application after use.
  • FIG. 31 is a schematic structural diagram of the artificial chord and the pin assembled together according to the second embodiment of the application.
  • Fig. 32 is a three-dimensional assembly schematic diagram of the valve repair suture device provided by the third embodiment of the application.
  • the position close to the operator is generally defined as the proximal end, and the position far away from the operator is defined as the distal end; the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction.
  • FIG. 2 is a three-dimensional assembly diagram of the valve repair suture device provided by the first embodiment of the application.
  • the valve repair suture device 100 includes an operating body 10, a sheath 30 and a valve suture device 50.
  • the sheath 30 is fixedly connected between the operating body 10 and the valve suture device 50.
  • the operating body 10 is used to facilitate the user to operate and control the valve suture device 50 to implant the artificial chordae to repair the heart valve.
  • FIG. 3 is a cross-sectional view of the valve suture device of the valve repair suture device shown in FIG. 2.
  • the valve suture device 50 is used to implant the artificial chord 200.
  • the valve suture device 50 includes a clamping assembly 60, a needle assembly 70 and a thread guide 80.
  • the lead guide 80 and the pin assembly 70 are movably passed through the clamping assembly 60 and the sheath 30.
  • the thread guide 80 and the pin assembly 70 are arranged at intervals.
  • the clamping assembly 60 is fixedly connected to the distal end of the sheath 30.
  • the clamping assembly 60 includes a proximal chuck 61, a distal chuck 63 and a chuck push tube 65.
  • the proximal chuck 61 is fixedly connected to the end of the sheath 30 away from the operating body 10 (that is, the distal end of the sheath 30), and the artificial chord 200 is contained in the proximal chuck 61.
  • the chuck push tube 65 movably passes through the proximal chuck 61 and is fixedly connected with the distal chuck 63.
  • the chuck push tube 65 is used to drive the distal chuck 63 to move relative to the proximal chuck 61, so that the distal chuck 63 and the proximal chuck 61 can relatively open and close, so as to cooperate to clamp or relax the heart valve.
  • the pin assembly 70 is movably installed in the proximal chuck 61 and is connected to the artificial chord 200 accommodated in the proximal chuck 61.
  • the lead guide 80 is movably installed in the chuck push tube 65 and the distal chuck 63.
  • the needle assembly 70 is used to pull the artificial chord 200 from the atrium side to the ventricular side to puncture the valve and penetrate the introducer 80.
  • the introducer 80 is used to tie the artificial chord 200 to pull the artificial chord 200 into the chuck push tube 65 and face Withdraw in the proximal direction, so that the part of the artificial chordae 200 is confined to the side of the valve close to the atrium.
  • the material of the distal chuck 63 is not limited.
  • the material of the distal chuck 63 can be, but is not limited to, polycarbonate (PC), acrylonitrile butadiene styrene copolymer (Acrylonitrile butadiene Styrene). copolymers (abbreviated as ABS) and so on.
  • PC polycarbonate
  • ABS acrylonitrile butadiene styrene copolymer
  • ABS acrylonitrile butadiene Styrene
  • the material of the proximal chuck 61 is not limited, and the material of the proximal chuck 61 can be, but is not limited to, PC, ABS, and the like.
  • the operating body 10 is provided with a pin control element 131, a lead control element 132 and a chuck control element 134.
  • the pin control member 131 is connected to the end of the pin assembly 70 away from the distal chuck 63, and is used to control and push the pin assembly 70 to move in the axial direction.
  • the lead control member 132 is connected to the end of the lead guide 80 away from the distal chuck 63 for controlling the lead guide 80 to move in the axial direction.
  • the chuck control member 134 is connected to the end of the chuck push tube 65 away from the distal chuck 63, and is used to control the chuck push tube 65 to move in the axial direction to push the distal chuck 63 to move relative to the proximal chuck 61, thereby
  • the distal chuck 63 and the proximal chuck 61 are controlled to clamp or loosen the valve relative to each other.
  • the distal chuck 63 and the proximal chuck 61 are in a relatively relaxed state.
  • the distal end chuck 63 and the proximal end chuck 61 are relatively clamped, and the valve repair suture device 100 is in a clamped state.
  • the chuck push tube 65 applies force to the distal chuck 63, so that the distal chuck 63 and the proximal chuck 61 cooperate with each other to clamp the valve (not shown).
  • the chuck push tube 65 applies force to the distal chuck 63, so that the distal chuck 63 and the proximal chuck 61 cooperate with each other to clamp the valve.
  • FIGS. 4 and 5 are only exemplary.
  • the distal chuck 63 and the proximal chuck 61 cooperate to clamp the valve
  • the distal chuck 63 There is a certain space between the proximal chuck 61 to accommodate the valve for clamping.
  • FIG. 6 is a schematic diagram of the suture device of the valve repair suture device shown in Fig. 2 in a punctured state with a partial structure removed.
  • FIG. 7 is a partial enlarged schematic diagram of the area I shown in FIG. 6.
  • Fig. 8 is a cross-sectional view of the suture device of the valve repair suture device shown in Fig. 2 in a punctured state.
  • the puncture state is that the needle assembly 70 can extend from the proximal chuck 61 into the distal chuck 63 and pass through the lead guide 80, so that the needle assembly 70 drives the artificial chord 200 to puncture the valve and penetrate the lead guide 80.
  • the pin assembly 70 under the action of the pin control member 131, the pin assembly 70 is forced, and the pin assembly 70 can extend from the proximal chuck 61 into the distal chuck 63 and pass through the lead guide 80.
  • the proximal chuck 61 includes a proximal chuck seat 611 and a proximal chuck main body 613 that are fixedly connected.
  • the proximal chuck base 611 is fixedly connected to the distal end of the sheath 30.
  • the proximal chuck seat 611 is located between the proximal chuck body 613 and the sheath 30.
  • the radial dimension of the end of the proximal collet holder 611 connected to the sheath tube 30 is smaller than the radial dimension of the end of the proximal collet holder 611 away from the sheath tube 30.
  • the pin assembly 70 movably passes through the proximal chuck main body 613 and the proximal chuck seat 611.
  • a thread storage tube 6119 is provided in the proximal chuck holder 611, and the suture storage tube 6119 is inserted into the proximal chuck holder 611 to accommodate the artificial chord 200.
  • the suture storage tube 6119 is also threaded through the sheath tube 30.
  • the proximal chuck seat 611 is provided with a channel 6113
  • the proximal chuck main body 613 is provided with a channel 6133 communicating with the channel 6113
  • the pin assembly 70 can movably penetrate through the channel 6113 and the channel 6133.
  • proximal chuck holder 611 can be omitted, for example, the proximal chuck body 613 is directly fixedly connected to the sheath 30.
  • FIG. 9 is a three-dimensional exploded schematic view of the suture device shown in FIG. 3.
  • the proximal chuck main body 613 is provided with a buckle 6131
  • the proximal chuck base 611 is provided with a clamping groove 6110
  • the proximal chuck body 613 and the proximal chuck base 611 pass through the buckle 6131 and the clamping groove.
  • the 6110 snaps and connects.
  • the connection manner of the proximal chuck holder 611 and the proximal chuck main body 613 is not limited, for example, a threaded connection or a glued connection can be adopted.
  • the distal chuck 63 includes a distal chuck body 631 and a distal chuck cap 633 that are fixedly connected.
  • the distal collet body 631 is located between the distal collet cap 633 and the proximal collet 61.
  • the distal chuck cap 633 is fixedly connected to the distal end of the chuck push tube 65, and the distal chuck main body 631 is sleeved on the outside of the chuck push tube 65.
  • distal chuck body 631 and the distal chuck cap 633 are fixedly connected is not limited.
  • threaded connection, glued connection, or snap connection may be adopted.
  • the adjacent end face of the distal chuck body 631 and the proximal chuck body 613 (that is, the proximal face of the distal chuck body 631) is the first clamping surface 6311, the proximal chuck body 613 and the distal chuck body
  • the adjacent end surface of 631 (that is, the distal end surface of the proximal chuck body 613) is the second clamping surface 6131.
  • the first clamping surface 6311 and the second clamping surface 6131 are opposed to each other and can cooperate with each other to clamp the valve.
  • the first clamping surface 6311 is an inclined surface arranged obliquely with respect to the axial direction of the chuck push tube 65
  • the second clamping surface 6131 is an inclined surface arranged obliquely with respect to the axial direction of the chuck push tube 65. Since the opposite end surfaces of the proximal chuck body 613 and the distal chuck body 631 are set to be inclined surfaces, that is, the first clamping surface 6311 and the second clamping surface 6131 are inclined surfaces, so that the clamping assembly 60 increases when clamping the valve.
  • the clamping area of the large distal chuck main body 631 and the proximal chuck main body 613 on the valve improves the stability of the clamping assembly 60 for clamping the valve and reduces damage to the valve.
  • the first clamping surface 6311 and the second clamping surface 6131 are concave and convex surfaces that cooperate with each other.
  • the concave-convex surface can increase the friction force when the distal chuck body 631 and the proximal chuck body 613 clamp the valve, and improve the reliability of the distal chuck body 631 and the proximal chuck body 613 when clamping the valve.
  • both the first clamping surface 6311 and the second clamping surface 6131 include corrugated protrusions.
  • first clamping surface 6311 and the second clamping surface 6131 are not restricted to be inclined surfaces arranged obliquely with respect to the axial direction of the chuck push tube 65, and the first clamping surface 6311 and the second clamping surface 6131 are not restricted to be concave and convex surfaces. It is sufficient that the first clamping surface 6311 and the second clamping surface 6131 can clamp or loosen the valve.
  • An end of the distal chuck main body 631 close to the distal chuck cap 633 (the distal end of the distal chuck main body 631) is provided with a groove 6314, and the lead guide 80 is partially accommodated in the groove 6314.
  • the groove 6314 includes a groove bottom wall 6317 (also shown in FIG. 8) and a groove side wall 6318 (also shown in FIG. 8) formed by bending and extending from the groove bottom wall 6317, the groove bottom wall 6317 and the distal chuck cap 633 are arranged oppositely, the thread guide 80 is in contact with the bottom wall 6317 of the groove, the bottom wall 6317 of the groove is provided with a through hole 6315 (also shown in FIG. 8), and the chuck push tube 65 is inserted through the through hole 6315.
  • the groove bottom wall 6317 is inclined with respect to the axial direction of the chuck push tube 65, and the included angle between the groove bottom wall 6317 and the end of the chuck push tube 65 away from the proximal chuck cap 611 is an obtuse angle ⁇ . That is, the bottom wall 6317 of the groove is an inclined surface arranged obliquely with respect to the end of the chuck push tube 65 away from the proximal chuck cap 611. In this way, it provides guidance for the movement of the thread guide 80 into the chuck push tube 65 and also provides guidance for the pin The assembly 70 is restrained by the thread guide 80 and retracted into the chuck push tube 65 to provide guidance.
  • the distal chuck body 631 is provided with a through hole 6313, and the through hole 6313 communicates with the channel 6133 in the proximal chuck body 613.
  • the chuck push tube 65 is movably inserted in the proximal chuck seat 611 and the proximal chuck body 613, and the chuck push tube 65 is fixedly pierced in the distal chuck body 631 and the distal chuck cap 633.
  • the chuck push tube 65 is provided with a lateral through hole 651, the lateral through hole 651 is in communication with the groove 6314, and the wire guide 80 is partially movably inserted through the lateral through hole 651 and partially accommodated in the groove 6314 in.
  • the distal end of the chuck cap 633 facing the distal end of the chuck body 631 (that is, the proximal end of the distal chuck cap 633) is provided with a recess 6330 ,
  • the recess 6330 is aligned with the groove 6314.
  • the recess 6330 is used to provide a guide for the pin assembly 70 to be pulled into the chuck push tube 65 while being restrained by the lead guide 80.
  • the bottom of the recess 6330 is also provided with a channel 6331 communicating with the through hole 6313, that is, the channel 6113, the channel 6133, the through hole 6313, and the channel 6331 are sequentially connected to form a channel for the pin assembly 70 to move through.
  • the holes 6313 and the channels 6331 are axially correspondingly arranged.
  • the needle assembly 70 can be movably inserted through the channel 6113, the channel 6133, the through hole 6313, and the channel 6331.
  • the channel 6331 communicates with the through hole 6313 and the groove 6314.
  • the clamping assembly 60 further includes a spacer 66, and the spacer 66 is fixedly connected to the end of the chuck push tube 65 away from the operating body 10.
  • the spacer 66 is fixedly received in the distal chuck cap 633 of the distal chuck 63, and the spacer 66 is fixedly sleeved on the distal end of the chuck push tube 65.
  • the spacer 66 is coated with a developing material.
  • the arrangement of the spacer 66 can increase the force-receiving area of the chuck push tube 65 and the distal chuck 63 on the one hand, and on the other hand play a role of visualization, so that the position of the valve suture device 50 can be observed during the operation.
  • the shape of the spacer 66 is a semi-cylindrical shape. It can be understood that the shape of the pad 66 is not limited, for example, a triangle, a square, a trapezoid, or the like can be adopted.
  • the spacer 66 can be omitted, and the chuck push tube 65 is directly and fixedly connected to the distal chuck cap 633.
  • the clamping assembly 60 further includes a guide rod 67, one end of the guide rod 67 is fixedly connected to the spacer 66, and the guide rod 67 is movably inserted through the proximal chuck body 613 and In the distal chuck main body 631, the guide rod 67 and the chuck push tube 65 are spaced apart.
  • the guide rod 67 is used to provide a guide for the chuck push tube 65 when the chuck push tube 65 drives the distal chuck 63 to move relative to the proximal chuck 61.
  • the number of guide rods 67 is two. It can be understood that the number of guide rods 67 is not limited.
  • the clamping assembly 60 further includes a limiting block 68, which is fixedly connected to the end of the guide rod 67 away from the cushion block 66 (ie, the proximal end of the guide rod 67).
  • the guide rod 67 is located between the spacer block 66 and the limit block 68.
  • the chuck push tube 65 penetrates through the limiting block 68.
  • the limiting block 68 is accommodated in the proximal chuck body 613.
  • the limiting block 68 is used to prevent the guide rod 67 from falling out of the proximal chuck body 613.
  • the limiting block 68 can be omitted and the guide rod 67 can be set as a telescopic rod, so that the guide rod 67 with telescoping function is directly and fixedly connected with the proximal chuck body 613.
  • FIG. 11 is a three-dimensional assembly diagram of the thread guide and the lead control member shown in FIG. 3.
  • the lead wire 80 includes a lead coil 81 and a driver 83 that are fixedly connected.
  • the end of the driver 83 away from the lead coil 81 is connected to the lead controller 132, and the driver 83 is located between the lead coil 81 and the lead coil 81.
  • the axial passage formed by the passage 6331 and the through hole 6313 is located in the lead coil 81.
  • the proximal chuck 61 and the distal chuck 63 are respectively provided with axial channels aligned with each other for the insertion of the needle assembly 70 and the artificial chord 200, and the axial channels in the distal chuck 63 communicate with each other.
  • the slot 6314 is located in the lead coil 81.
  • the driving member 83 is movably installed in the chuck push tube 65.
  • the lead coil 81 is movably received between the distal chuck main body 631 and the distal chuck cap 633, and the lead coil 81 is movably inserted in the lateral through hole 651 and received in the groove 6314.
  • the lead coil 81 is used to restrain the artificial chord 200 when the driving member 83 is retracted in the chuck push tube 65 toward the proximal direction.
  • FIG. 12 is a schematic diagram of the assembly of the distal chuck body of the suture device and the lead guide shown in FIG. 3.
  • the lead coil 81 includes a protruding portion 812 and a connecting portion 813.
  • the connecting portion 813 is fixedly connected to both sides of the protruding portion 812.
  • the end of the connecting portion 813 away from the protruding portion 812 is fixedly connected to the driving member 83.
  • the connecting portion 813 is located between the protruding portion 812 and Between the driver 83.
  • the protrusion 812 is used for facilitating the binding of the artificial chord 200 (as shown in FIG. 5 ), so as to prevent the artificial chord 200 from falling off the lead coil 81.
  • the lead coil 81 expands in a substantially fan shape from the connecting end of the lead coil 81 to the driving element 83 in a direction away from the connecting end.
  • the lead diameter of the lead coil 81 is smaller than the depth of the groove 6314.
  • the shape of the protrusion 812 is a half ring. It can be understood that the shape of the protrusion 812 is not limited, and it is sufficient to lock the artificial tendon 200 when the lead coil 81 is tightened so that the artificial tendon 200 will not fall off from the lead coil 81.
  • the shape of the protrusion 812 can be It is provided as a triangular protrusion or the like; the protrusion 812 may also be omitted.
  • the lead coil 81 is pre-shaped, so that the lead coil 81 is warped relative to the driving member 83 when the lead coil 81 is not subject to external force.
  • the lead coil 81 is arranged obliquely with respect to the driver 83, and the included angle ⁇ between the lead coil 81 and the driver 83 is an obtuse angle.
  • the angle between the lead coil 81 and the driver 83 is an obtuse angle, and the lead coil 81 is attached to the bottom wall of the groove. 6317 and the side wall 6318 of the slot, so that it is convenient for the lead coil 81 to be withdrawn into the chuck push tube 65.
  • the lead coil 81 is made of Nitinol wire. It can be understood that the material of the lead coil 81 is not limited. The expanded shape of the lead coil 81 is not limited.
  • the pin assembly 70 includes a pin push tube 71 and a pin 73.
  • the pin push tube 71 is connected to the pin control part 131 (as shown in FIG. 2), and the pin 73 is located in the pin push tube 71.
  • One end away from the pin control member 131 that is, the distal end of the pin push tube 71
  • the distal end of the pin push tube 71 can push against the proximal end of the pin 73
  • the pin push tube 71 is located between the pin 73 and the pin Between the control pieces 131.
  • the pin push tube 71 and the pin 73 are movably installed in the proximal chuck body 613 and the proximal chuck seat 611.
  • the needle 73 is used to puncture the valve.
  • the end adjacent to the pin 73 and the pin push tube 71 is used to fix and connect the artificial tendon 200, and the pin push tube 71 is used to push the pin 73.
  • FIG. 13 is a three-dimensional schematic diagram of the needle assembly and artificial tendon of the suture device shown in FIG. 3 being assembled together.
  • the outer diameter of the pin 73 is approximately the same as the outer diameter of the pin push tube 71 to facilitate the pin push tube 71 to push the pin 73.
  • the pin 73 and the pin push tube 71 can contact each other but are not fixedly connected. It can be understood that the outer diameter of the pin 73 and the outer diameter of the pin push tube 71 are not limited.
  • the needle 73 includes a needle tube 731 and a needle 733 that are integrally connected.
  • the needle tube 731 is disposed close to the needle push tube 71, the needle 733 is located at the distal end of the needle tube 731, and the needle tube 731 of the needle 73 is tubular.
  • the needle 733 of the insertion needle 73 is a beveled tip, which can reduce the puncture point and reduce the damage to the valve compared with the existing hook needle. It can be understood that the needle 733 of the insert needle 73 is not limited to a beveled tip, and it is sufficient to facilitate the puncture of the insert needle 73 and reduce damage to the valve. For example, the needle 733 of the insert needle 73 can be configured as a tapered tip. It can be understood that the material of the pin 73 is not limited. For example, the material of the pin 73 may be, but is not limited to, stainless steel or the like.
  • the number of pins 73 is two, and the number of pin push tubes 71 corresponds to two.
  • the number of the pins 73 and the pin push tube 71 is not limited, for example, the number of the pins 73 and the pin push tube 71 can be 1, 3, 4, and so on.
  • the pin assembly 70 further includes a pin catheter 75 (see also FIG. 3 ).
  • the pin catheter 75 is fixedly inserted into the proximal chuck body 613 and the proximal chuck seat 611.
  • the insertion needle 73 and the insertion needle push tube 71 can be movably inserted into the insertion needle catheter 75.
  • the pin guide 75 is used to guide the movement of the pin 73 and the pin push tube 71.
  • the needle catheter 75 can be omitted.
  • the inner wall of the through hole 6133 of the proximal chuck body 613 can be matched with the outer walls of the pin push tube 71 and the pin 73 to guide the movement of the pin 73 and the pin push tube 71 in the proximal chuck 61 That's it.
  • Figure 15 is a cross-sectional view of the pin assembly.
  • the cross section of the distal end of the needle push tube 71 is roughly a half-packed C-shaped groove structure for accommodating the end of the artificial chord 200.
  • the obstacle to the puncture valve when the artificial chord 200 is exposed outside the needle insertion tube 71 is reduced, and it is also convenient to place the artificial chord 200 in the needle insertion tube 71.
  • the shape of the cross section of the pin push tube 71 is not limited. For example, it can be set in a " ⁇ " shape, a "mouth” shape, a V shape, etc., but is not limited to.
  • Figure 16 is a perspective view of the needle assembly and artificial tendon of the suture device shown in Figure 6 assembled together
  • Figure 17 is another perspective of the needle assembly and artificial tendon of Figure 16 Schematic diagram.
  • the pin push tube 71 pushes the pin 73 to move away from the pin control member 131.
  • FIG. 18 is a perspective view of the artificial chord and the pin assembled together according to the first embodiment.
  • the artificial chord 200 includes a first fixed end 201, a second fixed end 203 and a chord main body 205.
  • the chord main body 205 is fixedly connected between the first fixed end 201 and the second fixed end 203.
  • the first fixed end 201 and the second fixed end 203 are respectively fixedly connected to a pin 73.
  • the chordae main body 205 is used to replace the dysfunctional chordae.
  • the artificial chord 200 is accommodated in the proximal chuck body 613 and the proximal chuck seat 611.
  • the chord main body 205 is bent into a "U" shape, and the first fixed end 201 and the second fixed end 203 are respectively fixedly connected to the pin 73.
  • the bent part of the chordae 205 is finally pulled to the side that contacts the valve near the atrium, so that A part of the artificial chordae 200 is confined to the side of the valve close to the atrium, and provides a starting end for the subsequent artificial chordae 200 to extend along the side of the ventricle and be fixed to the ventricular wall or papillary muscle.
  • the two ends of an artificial tendon 200 after being folded in half are the first fixed end 201 and the second fixed end 203, and the remaining part is the tendon main body 205, and the tendon main body 205 is accommodated in the slit.
  • Two ends of the artificial tendon 200 are respectively threaded through a needle tube 731, and the corresponding needle tube 731 is clamped by a wire clamp to respectively fix the first fixed end 201 and the second fixed end 203 with a pin 73 correspondingly.
  • the connection manner of the artificial chord 200 and the pin 73 is not limited, for example, the connection can be but not limited to by gluing.
  • the artificial chord 200 is made of sutures.
  • the sutures can be made of a smooth material, such as polytetrafluoroethylene (PTFE), or a non-smooth material, such as polyester resin (polyethylene terephthalate). , Referred to as PET).
  • PTFE polytetrafluoroethylene
  • PET polyester resin
  • the crimping pliers need to clamp the pin 73 and the suture with greater force, so that when the artificial tendon 200 is pulled by the lead coil 81, the proximal end of the pin 73 is stuck
  • the lead coil 81, the lead coil 81 drives the artificial tendon 200 together with the pin 73 to be withdrawn from the body through the chuck push tube 65; when the artificial tendon 200 is made of a relatively non-smooth material such as PET, the clamp is smaller Clamp the pin 73 and the artificial tendon 200 with force.
  • the channel 6331 in the distal chuck cap 633 will form a tight fit with the pin 73 when the pin 73 is inserted.
  • the artificial tendon 200 When the artificial tendon 200 is pulled by the lead loop 81, the artificial tendon 200 can be separated from the pin 73, and the friction between the artificial tendon 200 and the lead coil 81 is relatively large, and the lead coil 81 only drives the artificial tendon 200 to withdraw from the body through the chuck push tube 65.
  • the artificial tendon 200 may also be made of other materials.
  • a gasket 210 is passed through the artificial tendon 200, and the gasket 210 is provided with two through holes 211 for the first fixed end 201 and the second fixed end 203 to pass through, and the gasket 210 is used for
  • the contact area when the bending part of the chordae main body 205 contacts the valve is increased to reduce damage to the valve.
  • a spacer 210 is worn on the artificial chord 200, and the spacer 210 is movably accommodated in the proximal chuck 61.
  • the pad 210 The sheet 210 is located between the part of the artificial chordae 200 and the side of the valve close to the atrium.
  • the gasket 210 is provided with an arc protruding toward the bending part of the chordae main body 205, so that the gasket 210 can better fit the valve. It can be understood that the curvature of the gasket 210 is better to fit the valve to the greatest extent.
  • the material of the gasket 210 is not limited.
  • the material of the gasket 210 may be, but not limited to, polyester cloth, polytetrafluoroethylene (PTFE), polyester resin (polyethylene terephthalate, PET), etc. It can be understood that the gasket 210 may be omitted.
  • the proximal chuck main body 613 is further provided with a receiving portion 6134 for receiving the gasket 210.
  • the accommodating portion 6134 communicates with the through hole 6133 through which the pin assembly 70 is inserted as a whole.
  • the gasket 210 is accommodated in the accommodating portion 6134 in a posture parallel to the axial direction.
  • the needle 73 is pushed by the needle push tube 71 to pull the artificial chord 200 to puncture the valve and pass through the lead coil 81.
  • the lead coil 81 is in Driven by the driving member 83, it withdraws downwards, and then tightens to restrain the needle 73 and the artificial chord 200, and drives the needle 73 and the artificial chord 200 to withdraw until the gasket 210 fits the side of the valve close to the atrium, so that the artificial The chordae 200 portion is confined to the side of the valve near the atrium.
  • the valve repair suture device 100 further includes a probe 90, which is movably inserted through the proximal chuck body 611 and the proximal chuck seat 613, and the probe 90 is located Between the chuck push tube 65 and the pin assembly 70, the probe 90 and the chuck push tube 65 are spaced apart.
  • the operating body 10 is provided with a probe control member 135 which is connected to the proximal end of the probe 90 for controlling the movement of the probe 90.
  • the sheath 30 is fixedly connected between the operating body 10 and the proximal chuck base 611, and is used for accommodating the suture storage tube 6119, the needle assembly 70, the probe 90, the needle assembly 70 and the chuck push tube 65.
  • FIG. 19 is a schematic cross-sectional view of the sheath of the valve repair suture device shown in FIG. 2.
  • the suture storage tube 6119 is inserted through the sheath 30, the needle catheter 75 is inserted through the sheath 30, the probe 90 is movably inserted through the sheath 30, and the chuck push tube 65 is movably inserted through the sheath 30 ,
  • the suture storage tube 6119, the needle catheter 75, the probe 90, and the chuck push tube 65 are all spaced apart in the sheath 30.
  • cross-section of the sheath tube 30 is not restricted to be substantially circular; the length of the sheath tube 30 along its axial direction is not restricted, and the length of the sheath tube 30 is only required to meet the operation requirements.
  • the radial dimension of the proximal chuck holder 611 gradually increases from the proximal end to the distal end from the adaptable sheath 30 to accommodate the proximal chuck body 613, in order to match the proximal chuck holder 611 from the proximal end
  • the needle push tube 71 is provided with an inclined section adapted to the size change of the proximal collet holder 611.
  • the push tube passage 75 is provided with an inclined section adapted to the size change of the proximal chuck seat 611, and the chuck push tube 65 is also provided with an inclined section adapted to the size change of the proximal chuck seat 611.
  • the valve repair suture device is used to treat tricuspid regurgitation (TV as shown in FIG. 1).
  • the valve suture device 50 enters the right atrium (RA shown in Fig. 20) and the right ventricle (RV shown in Fig. 20) sequentially through the inferior vena cava (IVC as shown in Fig. 20) via the catheter route.
  • the proximal chuck 61 is located on the atrial side and the distal chuck 63 is located on the ventricle side, and the two clamp the valve.
  • the needle assembly 70 and the artificial chord 200 are accommodated on one side of the proximal chuck 61, and the lead coil 81 of the lead device 80 is accommodated in the distal chuck 63 In the groove 6314.
  • the needle assembly 70 pulls the artificial chord 200 (as shown in Figure 3) from the atrium side to the ventricle side to puncture the valve and then pass through the introducer 80.
  • the drive member 83 is retracted in the chuck push tube 65 toward the proximal direction to drive
  • the lead coil 81 tightens and binds the artificial chord 200 and pulls the artificial chord 200 and the pin 73 into the chuck push tube 65, so that the part of the artificial chord 200 is limited to the side of the valve near the atrium.
  • the artificial chord 200 The part of the artificial chordae 200 can be penetrated from the side of the valve close to the ventricle and can extend toward the ventricle side, and then the part of the artificial chordae 200 away from the valve can be fixed to the ventricular wall or papillary muscle on the side of the ventricle through an anchoring operation, thereby achieving transcatheter Way of artificial chord implantation and heart valve repair.
  • valve suture device 50 is used to treat the tricuspid valve (TV as shown in Figure 1) regurgitation through the catheter approach, and it can also enter the right atrium through the superior vena cava (SVC as shown in Figure 20) in turn (as shown in Figure 20). Show RA) and right ventricle (RV shown in Figure 20) to reach the tricuspid valve position.
  • TV as shown in Figure 1
  • SVC superior vena cava
  • RV right ventricle
  • a valve repair suture device is used to treat mitral valve regurgitation (MV as shown in Figure 1).
  • the valve suture device 50 passes through the inferior vena cava (IVC as shown in Figure 21) through the catheter to enter the right atrium (RA as shown in Figure 21), and then punctures the fossa ovale (Figure 21) Shown FO), enter the left atrium (LA as shown in Figure 21) and left ventricle (LV as shown in Figure 21) in sequence to reach the position of the mitral valve.
  • IVC inferior vena cava
  • RA right atrium
  • LV left ventricle
  • the valve suture device 50 is used to treat the mitral valve (MV as shown in Figure 1) regurgitation through the catheter approach, and it can also enter the right atrium through the superior vena cava (SVC as shown in Figure 21) first (as shown in Figure 21). Show RA), then puncture the fossa ovale (FO as shown in Figure 21), enter the left atrium (LA as shown in Figure 21) and left ventricle (LV as shown in Figure 21) in order to reach the position of the mitral valve .
  • SVC superior vena cava
  • Show RA puncture the fossa ovale
  • LA left atrium
  • LV left ventricle
  • valve repair suture device is introduced. Insert the valve suture device 50 of the valve repair suture device 100 through the inferior vena cava (IVC as shown in FIG. 20) into the right atrium (RA as shown in FIG. 20) and the right ventricle (RV as shown in FIG. 20) in turn.
  • the end chuck 61 is located on the atrium side, and the distal chuck 63 is located on the ventricle side.
  • the proximal chuck 61 and the distal chuck 63 are relatively opened under the drive of the chuck push tube 65. After the proximal chuck 61 and the distal chuck 63 clamp the valve under the drive of the chuck push tube 65 (shown as V in FIG. 22), they are detected by the probe 90 to confirm whether the valve is effectively clamped.
  • the needle 73 is pushed by the needle push tube 71 (as shown in FIG. 3) to puncture from the atrial side to the ventricle side.
  • the insert needle 73 drives the artificial chordae 200 to puncture the valve and pass through the lead coil 81, and the insert needle 73 and the artificial chordae 200 enter the distal chuck 63. Then the pin push tube 71 is withdrawn, and the pin 73 is separated from the pin push tube 71.
  • the driving member 83 is retracted toward the proximal direction, and the lead coil 81 is gradually tightened under the driving of the driving member 83, pulling the artificial tendon 200 and the pin 73 into the chuck push tube 65 and inserting The needle 73 slides into the chuck push tube 65 along the bottom wall of the recess 6330 (as shown in FIG. 10).
  • the lead coil 81 continues to withdraw to withdraw the artificial chord 200 and the pin 73 along the chuck push tube 65 toward the proximal direction, and the chord main body 205 of the artificial chord 200 shim 210 Take out from the accommodating portion 6134 (as shown in FIG. 18), the gasket 210 is brought into contact with the side of the valve close to the atrium, and the bending part of the artificial chordae 200 is limited to the side of the valve close to the atrium.
  • the gasket 210 contacts the surface of the valve on the atrial side, that is, the gasket 210 is located on the atrial side, so that the artificial chordae 200 is passed out from the ventricular side and extends toward the ventricular side, and then the valve suture device 50 ( As shown in Figure 4) and sheath 30 (as shown in Figure 4).
  • the part of the artificial chord 200 is limited to the side of the valve near the atrium, which is an artificial tendon.
  • the cord 200 extends along the side of the ventricle to provide the starting end. After adjusting the artificial chord 200 to make the regurgitation in the lightest state, fix the part of the artificial chord 200 away from the valve to the ventricular wall or papillary muscle through the anchor 600 to complete it. The implantation of the artificial tendon 200 is completed.
  • FIG. 31 is a schematic diagram of the assembly of the artificial chord and the pin provided by the second embodiment of the application.
  • the artificial chord 300 provided in the second embodiment includes a first fixed end 301, a second fixed end 303, a chord main body 305 and a stopper 307.
  • the chord main body 305 is fixedly connected between the first fixing end 301 and the second fixing end 303, and a gasket 310 is passed through the main chord 305.
  • the second fixed end 303 is fixedly connected to the pin 73, and the end of the first fixed end 301 away from the tendon main body 305 is fixedly connected to the limiting member 307.
  • the gasket 310 is provided with a through hole 311, and the chord main body 305 is inserted through the through hole 311.
  • the limiting member 307 is a spherical body, and the diameter of the limiting member 307 is larger than the diameter of the through hole 311.
  • the insertion needle 73 drives the chordal main body 305 of the artificial chordal 300 to puncture the valve from the atrium side to the ventricular side.
  • the stopper 307 compresses the spacer 310 so that the spacer 310 is in contact with the valve, thereby limiting the first fixed end 301 of the artificial chordae 300 on the side of the valve close to the atrium, so that the artificial chordae 200 extends along the side of the ventricle. Starting end.
  • FIG. 32 is a three-dimensional assembly diagram of the valve repair suture device provided by the third embodiment of the application.
  • the valve repair suture device 400 includes a base 90 fixedly connected to the operating body 10 and used to carry the operating body 10.
  • the base 90 can be omitted, and the operating body 10 can be held by human hands instead.

Abstract

The present application discloses a valve suture device (50) and a valve repair suture apparatus (100), wherein the valve suture device (50) comprises a clamping assembly (60), a needle assembly (70) and a thread guide (80); the clamping assembly (60) comprises a proximal chuck (61), a chuck push tube (65) and a distal chuck (63), the chuck push tube (65) is movably inserted into the proximal chuck (61) and fixedly connected to the distal chuck (63); the needle assembly (70) is movably inserted into the proximal chuck (61) and connected to the artificial tendon held in the proximal chuck; the thread guide (80) is movably inserted into the chuck push tube (65) and the distal chuck (63), the needle assembly (70) is used to pull the artificial tendon to puncture the valve from the atrium side to the ventricular side and penetrate the thread guide (80), the thread guide is used to tie the artificial tendon to pull the artificial tendon into the chuck push tube and withdraw it toward the proximal end, so that the part of the artificial tendon is confined to the side of the valve close to the atrium, and the artificial tendon passes out from the side of the ventricle and can extend along the side of the ventricle.

Description

瓣膜缝线器及瓣膜修复缝线装置Valve suture device and valve repair suture device 技术领域Technical field
本发明涉及医疗器械技术领域,特别涉及一种瓣膜缝线器及瓣膜修复缝线装置。The present invention relates to the technical field of medical devices, in particular to a valve suture device and a valve repair suture device.
背景技术Background technique
请参阅图1,左心房(如图1所示LA)和左心室(如图1所示LV)之间由二尖瓣(如图1所示MV)隔开,右心房(如图1所示RA)和右心室(如图1所示RV)由三尖瓣(如图1所示TV)隔开,三尖瓣及二尖瓣使血液只能由心房流入心室,而不能倒流。正常健康的二尖瓣及三尖瓣均具有多根腱索(如图1所示CT)。以二尖瓣为例,二尖瓣的瓣膜分为前叶和后叶,左心室处于舒张状态时,两者处于张开状态,血液从左心房流向左心室;左心室处于收缩状态时,腱索被拉伸,保证瓣膜不会被血流冲到心房侧,前、后叶闭合良好,从而保证血液从左心室经过主动脉瓣流向主动脉。若腱索出现病变或断裂,当左心室处于收缩状态时,二尖瓣不能像正常状态时恢复至关闭状态,血流的冲力会进一步导致瓣膜脱入左心房,造成血液返流。腱索出现病变或者腱索断裂后均不能自行修复,即使少数腱索断裂,也可使其它腱索张力增高而发生新的腱索断裂。二尖瓣腱索断裂典型表现为急性重症喘气、呼吸困难等左心衰竭、肺水肿表现,部分呈渐进性慢性心力衰竭。Please refer to Figure 1. The left atrium (LA as shown in Figure 1) and the left ventricle (LV as shown in Figure 1) are separated by the mitral valve (MV as shown in Figure 1), and the right atrium (as shown in Figure 1) Show RA) and the right ventricle (RV shown in Figure 1) are separated by the tricuspid valve (TV shown in Figure 1). The tricuspid valve and the mitral valve allow blood to flow from the atrium into the ventricle only, not back flow. Normal and healthy mitral and tricuspid valves have multiple chordae (CT as shown in Figure 1). Take the mitral valve as an example. The valve of the mitral valve is divided into anterior and posterior leaflets. When the left ventricle is in a diastolic state, the two are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contracted state, the tendon The cord is stretched to ensure that the valve will not be rushed to the atrium side by blood flow, and the front and back leaflets are closed well, thereby ensuring that blood flows from the left ventricle to the aorta through the aortic valve. If the chordae tendineae is diseased or ruptured, when the left ventricle is in a contracted state, the mitral valve cannot return to the closed state as in the normal state, and the momentum of the blood flow will further cause the valve to fall into the left atrium, causing blood reflux. The tendons cannot be repaired after they are damaged or ruptured. Even a small number of tendons ruptures can increase the tension of other tendons and cause new tendon ruptures. Mitral valve chordae rupture is typically manifested as acute severe wheezing, dyspnea and other left heart failure, pulmonary edema, and some are progressive chronic heart failure.
现有一种微创介入式的人工腱索的器械,其中,人工腱索连接套筒并置于远端夹头内,器械经心尖推进至左心室与左心房,远端夹头与近端夹头夹持瓣膜时,远端夹头位于心房侧,近端夹头位于心室侧,插针自近端夹头伸出穿过瓣膜并与位于远端夹头内的人工腱索固定连接,插针随即后撤并带动人工腱索及垫片依次穿过瓣膜回撤。垫片会接触瓣膜靠近心房侧的表面,即垫片位于心房侧,人工腱索在心室侧延伸,最后将人工腱索远离瓣膜的一端固定至心室壁或乳头肌上。There is a minimally invasive interventional artificial chordal instrument, in which the artificial chord is connected to the sleeve and placed in the distal chuck, the instrument is advanced through the apex to the left ventricle and the left atrium, the distal chuck and the proximal clip When the valve is clamped by the head, the distal chuck is located on the atrium side, and the proximal chuck is located on the ventricle side. The needle protrudes from the proximal chuck through the valve and is fixedly connected to the artificial chords in the distal chuck. The needle then withdraws and drives the artificial chord and gasket to withdraw through the valve in turn. The gasket will touch the surface of the valve near the atrium side, that is, the gasket is located on the atrium side, the artificial chordae extends on the ventricular side, and finally the end of the artificial chordae away from the valve is fixed to the ventricular wall or papillary muscle.
但是,若将这种结构形式的器械用于经导管途径的心脏瓣膜修复,即让该器械通过下腔静脉或上腔静脉依次进入心房与心室,由于夹持瓣膜后,远端夹头位于心室侧,近端夹头位于心房侧,最终垫片位于心室侧,人工腱索从瓣膜的心房侧穿出并沿心房侧延伸,人工腱索远离瓣膜的一端远离心室壁或乳头肌,从而不能实施人工腱索植入,实现不了瓣膜修复的功能。However, if the device of this structure is used for transcatheter heart valve repair, the device is allowed to enter the atrium and ventricle through the inferior vena cava or superior vena cava in turn. After clamping the valve, the distal clamp is located in the ventricle On the other side, the proximal chuck is located on the atrial side, and the final gasket is located on the ventricle side. The artificial chordae passes through the atrial side of the valve and extends along the atrial side. The end of the artificial chordae is far away from the valve and away from the ventricular wall or papillary muscle, so it cannot be implemented. Artificial tendon implantation cannot achieve the function of valve repair.
发明内容Summary of the invention
为了解决前述问题,本发明提供一种用于植入人工腱索的瓣膜缝线器和瓣膜修复缝线装置,在经导管途径进行心脏瓣膜修复时,使人工腱索从瓣膜靠近心室的一侧穿出并沿心室侧延伸,实现人工腱索的植入。In order to solve the aforementioned problems, the present invention provides a valve suture device and a valve repair suture device for implanting artificial chordae. When the heart valve is repaired via a catheter, the artificial chordae is moved from the side of the valve close to the ventricle. Pass out and extend along the side of the ventricle to realize the implantation of artificial chordae.
第一方面,本申请提供一种瓣膜缝线器,用于植入人工腱索,包括夹持组件、插针组件及引线器;所述夹持组件包括近端夹头、夹头推管与远端夹头,所述夹头推管活动穿设于所述近端夹头内并固定连接所述远端夹头,所述夹头推管用于带动所述远端夹头相对所 述近端夹头运动,以夹持或放松瓣膜;所述插针组件活动穿设于所述近端夹头内并连接被容纳于所述近端夹头内的所述人工腱索,所述引线器活动穿设于所述夹头推管及所述远端夹头内,所述插针组件用于牵引所述人工腱索自心房侧向心室侧穿刺瓣膜并穿入所述引线器,所述引线器用于束缚所述人工腱索并牵引所述人工腱索进入所述夹头推管并朝近端方向回撤,以使得所述人工腱索的部分被限位于所述瓣膜靠近心房的一侧。In the first aspect, the present application provides a valve suture device for implanting artificial chordae, including a clamping assembly, a needle assembly, and a guide; the clamping assembly includes a proximal chuck, a chuck push tube, and The distal chuck, the chuck push tube is movably inserted in the proximal chuck and fixedly connected to the distal chuck, and the chuck push tube is used to drive the distal chuck relative to the proximal chuck. The end chuck moves to clamp or relax the valve; the pin assembly is movably installed in the proximal chuck and connected to the artificial chord which is contained in the proximal chuck, and the lead The device is movably installed in the chuck push tube and the distal chuck, and the needle assembly is used to pull the artificial chordae from the atrium side to the ventricle side to puncture the valve and penetrate the lead guide. The thread guide is used to bind the artificial chordae and pull the artificial chordae into the chuck push tube and withdraw in the proximal direction, so that the part of the artificial chordae is confined to the valve near the atrium One side.
第二方面,本申请还提供一种瓣膜修复缝线装置,包括上述的瓣膜缝线器及操作主体,所述操作主体上设置插针控制件、引线控制件及夹头控制件,所述插针控制件与所述插针组件的近端连接以控制所述插针组件沿轴向移动,所述引线控制件与所述引线器的近端连接以控制所述引线器沿轴向移动,所述夹头控制件与所述夹头推管的近端连接以控制所述夹头推管沿轴向移动。In the second aspect, the present application also provides a valve repair suture device, which includes the valve suture device described above and an operating body. The operating body is provided with a needle control element, a lead control element, and a chuck control element. The needle control member is connected with the proximal end of the pin assembly to control the movement of the pin assembly in the axial direction, and the lead control member is connected with the proximal end of the introducer to control the movement of the introducer in the axial direction, The chuck control member is connected with the proximal end of the chuck push tube to control the chuck push tube to move in the axial direction.
本申请提供的瓣膜缝线器及瓣膜修复缝线装置,由于插针组件活动穿设于近端夹头内并连接容纳于近端夹头内的人工腱索,引线器活动穿设于夹头推管及远端夹头内,插针能够牵引人工腱索自心房侧向心室侧穿刺瓣膜后从引线器中穿出,引线器能够束缚人工腱索并牵引人工腱索进入夹头推管朝近端方向回撤,从而使得人工腱索的一部分能够被限位在瓣膜靠近心房的一侧,且人工腱索从心室侧穿出,能够沿心室侧延伸,后续通过锚定操作能够将人工腱索远离瓣膜的部分固定至心室侧的心室壁或乳头肌上,从而实现经导管途径的人工腱索植入及心脏瓣膜修复。In the valve suture device and valve repair suture device provided in the present application, since the needle assembly is movably inserted in the proximal chuck and connected to the artificial chords contained in the proximal chuck, the thread guide is movably installed in the chuck In the push tube and the distal chuck, the needle can pull the artificial chordae from the atrium side to the ventricular side and then pass through the introducer. The introducer can bind the artificial chordae and pull the artificial chord into the chuck. Withdraw in the proximal direction, so that a part of the artificial chordae can be confined on the side of the valve close to the atrium, and the artificial chordae can pass through from the ventricle side and extend along the ventricular side. The artificial tendon can be anchored later by anchoring. The part of the cord away from the valve is fixed to the ventricular wall or papillary muscle on the side of the ventricle, so as to realize the implantation of the artificial chordae and the repair of the heart valve through the catheter.
附图说明Description of the drawings
为了更清楚地说明本发明实施方式或现有技术中的技术方案,下面将对实施方式或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施方式,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。In order to more clearly explain the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.
图1为心脏结构示意图。Figure 1 is a schematic diagram of the heart structure.
图2为本申请第一实施方式提供的瓣膜修复缝线装置的立体组装示意图。Fig. 2 is a three-dimensional assembly schematic diagram of the valve repair suture device provided by the first embodiment of the application.
图3为图2所示的瓣膜修复缝线装置的瓣膜缝线器的剖面图。Fig. 3 is a cross-sectional view of the valve suture device of the valve repair suture device shown in Fig. 2.
图4为图2所示的瓣膜修复缝线装置处于夹持状态的瓣膜缝线器的示意图。Fig. 4 is a schematic diagram of the valve suture device in a clamped state of the valve repair suture device shown in Fig. 2.
图5为图2所示的瓣膜修复缝线装置处于夹持状态的瓣膜缝线器的立体剖视图。Fig. 5 is a three-dimensional cross-sectional view of the valve suture device of the valve repair suture device shown in Fig. 2 in a clamped state.
图6为图2所示的瓣膜修复缝线装置的瓣膜缝线器处于穿刺状态去除部分结构的示意图。Fig. 6 is a schematic diagram of the valve suture device of the valve repair suture device shown in Fig. 2 in a punctured state with part of the structure removed.
图7为图6所示的区域I的局部放大示意图。FIG. 7 is a partial enlarged schematic diagram of the area I shown in FIG. 6.
图8为图2所示的瓣膜修复缝线装置处于穿刺状态的瓣膜缝线器剖视图。Fig. 8 is a cross-sectional view of the valve suture device of the valve repair suture device shown in Fig. 2 in a punctured state.
图9为图3所示的瓣膜缝线器的立体分解示意图。Fig. 9 is a three-dimensional exploded schematic diagram of the valve suture device shown in Fig. 3.
图10为图3所示的瓣膜缝线器的远端夹头帽结构示意图。FIG. 10 is a schematic diagram of the structure of the distal chuck cap of the valve suture device shown in FIG. 3.
图11为图3所示的引线器与引线控制件的立体组装示意图。FIG. 11 is a three-dimensional assembly schematic diagram of the thread guide and the lead control component shown in FIG. 3.
图12为图3所示的瓣膜缝线器的远端夹头主体与引线器组装在一起的示意图。Fig. 12 is a schematic diagram of the distal chuck body of the valve suture device shown in Fig. 3 and the lead guide being assembled together.
图13为图3所示的瓣膜缝线器的插针组件及人工腱索组装在一起的立体示意图。Fig. 13 is a three-dimensional schematic diagram of the assembly of the needle assembly and the artificial chord of the valve suture device shown in Fig. 3 together.
图14为图3所示的瓣膜缝线器的插针组件的轴向剖面图。Fig. 14 is an axial cross-sectional view of the needle assembly of the valve suture device shown in Fig. 3.
图15为插针组件的垂直于轴向的剖面图。Figure 15 is a cross-sectional view perpendicular to the axial direction of the pin assembly.
图16为图6所示的瓣膜缝线器的插针组件及人工腱索组装在一起的示意图。Fig. 16 is a schematic diagram showing the assembly of the needle assembly and the artificial chord of the valve suture device shown in Fig. 6 together.
图17为图16的插针组件及人工腱索另一视角的示意图。Fig. 17 is a schematic diagram of the pin assembly and artificial chord of Fig. 16 from another perspective.
图18为第一实施方式提供的人工腱索与插针组装在一起的示意图。Fig. 18 is a schematic diagram of the artificial chord and the pin assembled together according to the first embodiment.
图19为图3所示的瓣膜缝线器的鞘管的剖面图。Fig. 19 is a cross-sectional view of the sheath of the valve suture device shown in Fig. 3.
图20为图2所示的瓣膜修复缝线装置用于治疗三尖瓣的应用场景示意图。Fig. 20 is a schematic diagram of an application scenario of the valve repair suture device shown in Fig. 2 for treating a tricuspid valve.
图21为图2所示的瓣膜修复缝线装置用于治疗二尖瓣的应用场景示意图。Fig. 21 is a schematic diagram of an application scenario of the valve repair suture device shown in Fig. 2 for treating the mitral valve.
图22为图2所示的瓣膜修复缝线装置夹持瓣膜前的示意图。Fig. 22 is a schematic diagram of the valve repair suture device shown in Fig. 2 before clamping the valve.
图23为图2所示的瓣膜修复缝线装置处于穿刺状态时的示意图。Fig. 23 is a schematic diagram of the valve repair suture device shown in Fig. 2 when it is in a puncture state.
图24为图2所示的瓣膜修复缝线装置处于穿刺状态时的立体示意图。Fig. 24 is a three-dimensional schematic diagram of the valve repair suture device shown in Fig. 2 when it is in a puncture state.
图25为图2所示的瓣膜修复缝线装置的引线器开始后撤时的示意图。Fig. 25 is a schematic diagram when the introducer of the valve repair suture device shown in Fig. 2 starts to withdraw.
图26为图2所示的瓣膜修复缝线装置的引线器开始后撤时的立体示意图。Fig. 26 is a three-dimensional schematic diagram when the introducer of the valve repair suture device shown in Fig. 2 starts to be withdrawn.
图27为图2所示的瓣膜修复缝线装置的引线器撤出后的示意图。Fig. 27 is a schematic diagram after the introducer of the valve repair suture device shown in Fig. 2 is withdrawn.
图28为图2所示的瓣膜修复缝线装置的引线器撤出后的立体示意图。Fig. 28 is a three-dimensional schematic diagram of the valve repair suture device shown in Fig. 2 after the introducer is withdrawn.
图29为图2所示的瓣膜修复缝线装置的引线器撤出后人工腱索的状态示意图。Fig. 29 is a schematic diagram showing the state of the artificial chordae after the introducer of the valve repair suture device shown in Fig. 2 is withdrawn.
图30为本申请一实施方式提供的瓣膜修复缝线装置使用后的效果示意图。FIG. 30 is a schematic diagram of the effect of the valve repair suture device provided by an embodiment of the application after use.
图31为本申请第二实施方式提供的人工腱索与插针组装在一起的结构示意图。FIG. 31 is a schematic structural diagram of the artificial chord and the pin assembled together according to the second embodiment of the application.
图32为本申请第三实施方式提供的瓣膜修复缝线装置的立体组装示意图。Fig. 32 is a three-dimensional assembly schematic diagram of the valve repair suture device provided by the third embodiment of the application.
具体实施方式Detailed ways
下面将结合本发明实施方式中的附图,对本发明实施方式中的技术方案进行清楚、完整地描述,显然,所描述的实施方式仅仅是本发明一部分实施方式,而不是全部的实施方式。基于本发明中的实施方式,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施方式,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.
在介入医疗器械技术领域,一般将靠近操作者的方位定义为近端,远离操作者的方位定义为远端;将柱体、管体等一类物体的旋转中心轴的方向定义为轴向。In the technical field of interventional medical devices, the position close to the operator is generally defined as the proximal end, and the position far away from the operator is defined as the distal end; the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction.
第一实施方式The first embodiment
请参阅图2,图2为本申请第一实施方式提供的瓣膜修复缝线装置的立体组装示意图。Please refer to FIG. 2, which is a three-dimensional assembly diagram of the valve repair suture device provided by the first embodiment of the application.
瓣膜修复缝线装置100,包括操作主体10、鞘管30及瓣膜缝线器50。鞘管30固定连接于操作主体10与瓣膜缝线器50之间。操作主体10用于方便用户操作控制瓣膜缝线器50来植入人工腱索以对心脏瓣膜实施修复。The valve repair suture device 100 includes an operating body 10, a sheath 30 and a valve suture device 50. The sheath 30 is fixedly connected between the operating body 10 and the valve suture device 50. The operating body 10 is used to facilitate the user to operate and control the valve suture device 50 to implant the artificial chordae to repair the heart valve.
请结合参阅图2及图3,图3为图2所示的瓣膜修复缝线装置的瓣膜缝线器的剖面图。瓣膜缝线器50,用于植入人工腱索200。瓣膜缝线器50包括夹持组件60、插针组件70及引线器80。引线器80及插针组件70活动地穿设于夹持组件60及鞘管30。引线器80及插针组件70间隔设置。夹持组件60与鞘管30的远端固定连接。Please refer to FIGS. 2 and 3 in combination. FIG. 3 is a cross-sectional view of the valve suture device of the valve repair suture device shown in FIG. 2. The valve suture device 50 is used to implant the artificial chord 200. The valve suture device 50 includes a clamping assembly 60, a needle assembly 70 and a thread guide 80. The lead guide 80 and the pin assembly 70 are movably passed through the clamping assembly 60 and the sheath 30. The thread guide 80 and the pin assembly 70 are arranged at intervals. The clamping assembly 60 is fixedly connected to the distal end of the sheath 30.
请一并参阅图4及图5,夹持组件60包括近端夹头61、远端夹头63与夹头推管65。近端夹头61与鞘管30远离操作主体10的一端(即鞘管30的远端)固定连接,近端夹头 61内容纳有人工腱索200。夹头推管65活动穿设于近端夹头61并与远端夹头63固定连接。夹头推管65用于带动远端夹头63相对近端夹头61运动,以使远端夹头63与近端夹头61能够相对开合,从而配合夹持或放松心脏的瓣膜。插针组件70活动穿设于近端夹头61内并连接被容纳于近端夹头61内的人工腱索200。引线器80活动穿设于夹头推管65及远端夹头63内。插针组件70用于牵引人工腱索200自心房侧向心室侧穿刺瓣膜并穿入引线器80,引线器80用于束缚人工腱索200以牵引人工腱索200进入夹头推管65并朝近端方向回撤,使得人工腱索200的部分被限位于瓣膜靠近心房的一侧。Please refer to FIGS. 4 and 5 together. The clamping assembly 60 includes a proximal chuck 61, a distal chuck 63 and a chuck push tube 65. The proximal chuck 61 is fixedly connected to the end of the sheath 30 away from the operating body 10 (that is, the distal end of the sheath 30), and the artificial chord 200 is contained in the proximal chuck 61. The chuck push tube 65 movably passes through the proximal chuck 61 and is fixedly connected with the distal chuck 63. The chuck push tube 65 is used to drive the distal chuck 63 to move relative to the proximal chuck 61, so that the distal chuck 63 and the proximal chuck 61 can relatively open and close, so as to cooperate to clamp or relax the heart valve. The pin assembly 70 is movably installed in the proximal chuck 61 and is connected to the artificial chord 200 accommodated in the proximal chuck 61. The lead guide 80 is movably installed in the chuck push tube 65 and the distal chuck 63. The needle assembly 70 is used to pull the artificial chord 200 from the atrium side to the ventricular side to puncture the valve and penetrate the introducer 80. The introducer 80 is used to tie the artificial chord 200 to pull the artificial chord 200 into the chuck push tube 65 and face Withdraw in the proximal direction, so that the part of the artificial chordae 200 is confined to the side of the valve close to the atrium.
可以理解,不限制远端夹头63的材质,远端夹头63的材质可以但不限于为聚碳酸酯(Polycarbonate,简称PC)、丙烯腈-丁二烯-苯乙烯共聚物(Acrylonitrile butadiene Styrene copolymers,简称ABS)等。可以理解,不限制近端夹头61的材质,近端夹头61的材质可以但不限于为PC、ABS等。It is understandable that the material of the distal chuck 63 is not limited. The material of the distal chuck 63 can be, but is not limited to, polycarbonate (PC), acrylonitrile butadiene styrene copolymer (Acrylonitrile butadiene Styrene). copolymers (abbreviated as ABS) and so on. It can be understood that the material of the proximal chuck 61 is not limited, and the material of the proximal chuck 61 can be, but is not limited to, PC, ABS, and the like.
操作主体10上设置插针控制件131、引线控制件132及夹头控制件134。插针控制件131与插针组件70远离远端夹头63的一端连接,用于控制推动插针组件70沿轴向移动。引线控制件132与引线器80远离远端夹头63的一端连接,用于控制引线器80沿轴向移动。夹头控制件134与夹头推管65远离远端夹头63的一端连接,用于控制夹头推管65沿轴向移动,以推动远端夹头63相对近端夹头61运动,从而控制远端夹头63和近端夹头61相对夹持或放松瓣膜。如图2所示,远端夹头63与近端夹头61处于相对放松的状态。如图4所示,远端夹头63与近端夹头61相对夹紧,瓣膜修复缝线装置100处于夹持状态。所述夹持状态为,夹头推管65对远端夹头63施力,使得远端夹头63与近端夹头61相互配合夹紧瓣膜(图未示)。本实施方式中,在夹头控制件134的作用下,夹头推管65对远端夹头63施力,使得远端夹头63与近端夹头61相互配合夹紧瓣膜。The operating body 10 is provided with a pin control element 131, a lead control element 132 and a chuck control element 134. The pin control member 131 is connected to the end of the pin assembly 70 away from the distal chuck 63, and is used to control and push the pin assembly 70 to move in the axial direction. The lead control member 132 is connected to the end of the lead guide 80 away from the distal chuck 63 for controlling the lead guide 80 to move in the axial direction. The chuck control member 134 is connected to the end of the chuck push tube 65 away from the distal chuck 63, and is used to control the chuck push tube 65 to move in the axial direction to push the distal chuck 63 to move relative to the proximal chuck 61, thereby The distal chuck 63 and the proximal chuck 61 are controlled to clamp or loosen the valve relative to each other. As shown in FIG. 2, the distal chuck 63 and the proximal chuck 61 are in a relatively relaxed state. As shown in FIG. 4, the distal end chuck 63 and the proximal end chuck 61 are relatively clamped, and the valve repair suture device 100 is in a clamped state. In the clamping state, the chuck push tube 65 applies force to the distal chuck 63, so that the distal chuck 63 and the proximal chuck 61 cooperate with each other to clamp the valve (not shown). In this embodiment, under the action of the chuck control member 134, the chuck push tube 65 applies force to the distal chuck 63, so that the distal chuck 63 and the proximal chuck 61 cooperate with each other to clamp the valve.
可以理解,图4与图5仅为示例性地,在瓣膜修复缝线装置100对心脏进行修复过程中,远端夹头63与近端夹头61配合夹紧瓣膜时,远端夹头63与近端夹头61之间具一定空间以容纳瓣膜进行夹持。It can be understood that FIGS. 4 and 5 are only exemplary. In the process of repairing the heart by the valve repair suture device 100, when the distal chuck 63 and the proximal chuck 61 cooperate to clamp the valve, the distal chuck 63 There is a certain space between the proximal chuck 61 to accommodate the valve for clamping.
如图6、图7及图8所示,图6为图2所示的瓣膜修复缝线装置的缝线器处于穿刺状态去除部分结构的示意图。图7为图6所示的区域I的局部放大示意图。图8为图2所示的瓣膜修复缝线装置处于穿刺状态的缝线器剖视图。所述穿刺状态为,插针组件70能够从近端夹头61伸入远端夹头63并穿过引线器80,从而插针组件70带动人工腱索200穿刺瓣膜并穿入引线器80。本实施方式中,在插针控制件131的作用下,对插针组件70施力,插针组件70能够从近端夹头61伸入远端夹头63并穿过引线器80。As shown in Fig. 6, Fig. 7 and Fig. 8, Fig. 6 is a schematic diagram of the suture device of the valve repair suture device shown in Fig. 2 in a punctured state with a partial structure removed. FIG. 7 is a partial enlarged schematic diagram of the area I shown in FIG. 6. Fig. 8 is a cross-sectional view of the suture device of the valve repair suture device shown in Fig. 2 in a punctured state. The puncture state is that the needle assembly 70 can extend from the proximal chuck 61 into the distal chuck 63 and pass through the lead guide 80, so that the needle assembly 70 drives the artificial chord 200 to puncture the valve and penetrate the lead guide 80. In this embodiment, under the action of the pin control member 131, the pin assembly 70 is forced, and the pin assembly 70 can extend from the proximal chuck 61 into the distal chuck 63 and pass through the lead guide 80.
请再次参阅图2、图3及图9,近端夹头61包括固定连接的近端夹头座611及近端夹头主体613。近端夹头座611与鞘管30的远端固定连接。近端夹头座611位于近端夹头主体613与鞘管30之间。近端夹头座611与鞘管30连接一端的径向尺寸小于近端夹头座611远离鞘管30的一端的径向尺寸。插针组件70活动穿设于近端夹头主体613和近端夹头座611。Please refer to FIGS. 2, 3 and 9 again, the proximal chuck 61 includes a proximal chuck seat 611 and a proximal chuck main body 613 that are fixedly connected. The proximal chuck base 611 is fixedly connected to the distal end of the sheath 30. The proximal chuck seat 611 is located between the proximal chuck body 613 and the sheath 30. The radial dimension of the end of the proximal collet holder 611 connected to the sheath tube 30 is smaller than the radial dimension of the end of the proximal collet holder 611 away from the sheath tube 30. The pin assembly 70 movably passes through the proximal chuck main body 613 and the proximal chuck seat 611.
具体地,近端夹头座611内设置线储藏管6119,缝线储藏管6119穿设于近端夹头座611中,用于收容人工腱索200。缝线储藏管6119还穿设于鞘管30中。Specifically, a thread storage tube 6119 is provided in the proximal chuck holder 611, and the suture storage tube 6119 is inserted into the proximal chuck holder 611 to accommodate the artificial chord 200. The suture storage tube 6119 is also threaded through the sheath tube 30.
在本实施方式中,近端夹头座611上设置通道6113,近端夹头主体613开设与通道6113 连通的通道6133,插针组件70能够活动地穿设于通道6113及通道6133。In this embodiment, the proximal chuck seat 611 is provided with a channel 6113, the proximal chuck main body 613 is provided with a channel 6133 communicating with the channel 6113, and the pin assembly 70 can movably penetrate through the channel 6113 and the channel 6133.
可以理解,近端夹头座611可以省略,例如,近端夹头主体613直接与鞘管30固定连接。It can be understood that the proximal chuck holder 611 can be omitted, for example, the proximal chuck body 613 is directly fixedly connected to the sheath 30.
请参阅图9,图9为图3所示的缝线器的立体分解示意图。Please refer to FIG. 9. FIG. 9 is a three-dimensional exploded schematic view of the suture device shown in FIG. 3.
在本实施方式中,近端夹头主体613上设置卡扣6131,近端夹头座611上设置卡槽6110,近端夹头主体613与近端夹头座611通过卡扣6131和卡槽6110卡合相接。可以理解,不限制近端夹头座611和近端夹头主体613的连接方式,例如,可采用螺纹连接或胶合连接等。In this embodiment, the proximal chuck main body 613 is provided with a buckle 6131, the proximal chuck base 611 is provided with a clamping groove 6110, and the proximal chuck body 613 and the proximal chuck base 611 pass through the buckle 6131 and the clamping groove. The 6110 snaps and connects. It can be understood that the connection manner of the proximal chuck holder 611 and the proximal chuck main body 613 is not limited, for example, a threaded connection or a glued connection can be adopted.
远端夹头63包括固定连接的远端夹头主体631及远端夹头帽633。远端夹头主体631位于远端夹头帽633与近端夹头61之间。远端夹头帽633与夹头推管65的远端固定连接,远端夹头主体631套设于夹头推管65外部。The distal chuck 63 includes a distal chuck body 631 and a distal chuck cap 633 that are fixedly connected. The distal collet body 631 is located between the distal collet cap 633 and the proximal collet 61. The distal chuck cap 633 is fixedly connected to the distal end of the chuck push tube 65, and the distal chuck main body 631 is sleeved on the outside of the chuck push tube 65.
可以理解,不限制远端夹头主体631与远端夹头帽633固定连接的方式,例如,可以采用螺纹连接、胶合连接或卡扣连接等。It can be understood that the manner in which the distal chuck body 631 and the distal chuck cap 633 are fixedly connected is not limited. For example, threaded connection, glued connection, or snap connection may be adopted.
远端夹头主体631与近端夹头主体613相邻的端面(即远端夹头主体631的近端面)为第一夹持面6311,近端夹头主体613与远端夹头主体631相邻的端面(即近端夹头主体613的远端面)为第二夹持面6131。第一夹持面6311与第二夹持面6131相对设置并能够相互配合夹持瓣膜。第一夹持面6311为相对夹头推管65的轴向倾斜设置的斜面,第二夹持面6131为相对夹头推管65的轴向倾斜设置的斜面。由于近端夹头主体613和远端夹头主体631的相对端面设置为斜面,即第一夹持面6311与第二夹持面6131为斜面,使夹持组件60在夹持瓣膜时,增大远端夹头主体631和近端夹头主体613对瓣膜的夹持面积,从而提高夹持组件60夹持瓣膜的稳定性,亦减小对瓣膜的损伤。The adjacent end face of the distal chuck body 631 and the proximal chuck body 613 (that is, the proximal face of the distal chuck body 631) is the first clamping surface 6311, the proximal chuck body 613 and the distal chuck body The adjacent end surface of 631 (that is, the distal end surface of the proximal chuck body 613) is the second clamping surface 6131. The first clamping surface 6311 and the second clamping surface 6131 are opposed to each other and can cooperate with each other to clamp the valve. The first clamping surface 6311 is an inclined surface arranged obliquely with respect to the axial direction of the chuck push tube 65, and the second clamping surface 6131 is an inclined surface arranged obliquely with respect to the axial direction of the chuck push tube 65. Since the opposite end surfaces of the proximal chuck body 613 and the distal chuck body 631 are set to be inclined surfaces, that is, the first clamping surface 6311 and the second clamping surface 6131 are inclined surfaces, so that the clamping assembly 60 increases when clamping the valve. The clamping area of the large distal chuck main body 631 and the proximal chuck main body 613 on the valve improves the stability of the clamping assembly 60 for clamping the valve and reduces damage to the valve.
本实施方式中,第一夹持面6311与第二夹持面6131为相互配合的凹凸面。凹凸面能够增大远端夹头主体631及近端夹头主体613夹持瓣膜时的摩擦力,提高远端夹头主体631及近端夹头主体613夹持瓣膜时的可靠性。在本实施方式中,第一夹持面6311与第二夹持面6131均包括瓦楞状凸起。In this embodiment, the first clamping surface 6311 and the second clamping surface 6131 are concave and convex surfaces that cooperate with each other. The concave-convex surface can increase the friction force when the distal chuck body 631 and the proximal chuck body 613 clamp the valve, and improve the reliability of the distal chuck body 631 and the proximal chuck body 613 when clamping the valve. In this embodiment, both the first clamping surface 6311 and the second clamping surface 6131 include corrugated protrusions.
可以理解,不限制第一夹持面6311与第二夹持面6131为相对夹头推管65轴向倾斜设置的斜面,不限制第一夹持面6311与第二夹持面6131为凹凸面,第一夹持面6311与第二夹持面6131能够夹持或放松瓣膜即可。It can be understood that the first clamping surface 6311 and the second clamping surface 6131 are not restricted to be inclined surfaces arranged obliquely with respect to the axial direction of the chuck push tube 65, and the first clamping surface 6311 and the second clamping surface 6131 are not restricted to be concave and convex surfaces. It is sufficient that the first clamping surface 6311 and the second clamping surface 6131 can clamp or loosen the valve.
远端夹头主体631靠近远端夹头帽633一端(远端夹头主体631的远端)设有凹槽6314,引线器80部分容置于凹槽6314。An end of the distal chuck main body 631 close to the distal chuck cap 633 (the distal end of the distal chuck main body 631) is provided with a groove 6314, and the lead guide 80 is partially accommodated in the groove 6314.
凹槽6314包括槽底壁6317(亦如图8所示)及自槽底壁6317弯折延伸形成的槽侧壁6318(亦如图8所示),槽底壁6317与远端夹头帽633相对设置,引线器80与槽底壁6317接触,槽底壁6317设有通孔6315(亦如图8所示),夹头推管65穿设于通孔6315中。The groove 6314 includes a groove bottom wall 6317 (also shown in FIG. 8) and a groove side wall 6318 (also shown in FIG. 8) formed by bending and extending from the groove bottom wall 6317, the groove bottom wall 6317 and the distal chuck cap 633 are arranged oppositely, the thread guide 80 is in contact with the bottom wall 6317 of the groove, the bottom wall 6317 of the groove is provided with a through hole 6315 (also shown in FIG. 8), and the chuck push tube 65 is inserted through the through hole 6315.
请再次参阅图3,槽底壁6317相对夹头推管65的轴向倾斜设置,槽底壁6317与夹头推管65远离近端夹头帽611的一端之间的夹角为钝角α。即槽底壁6317为相对夹头推管65远离近端夹头帽611的一端倾斜设置的斜面,如此,对引线器80撤入夹头推管65的运动提供导向,并且,也对插针组件70受引线器80束缚撤入夹头推管65的运动提供导向。Please refer to FIG. 3 again. The groove bottom wall 6317 is inclined with respect to the axial direction of the chuck push tube 65, and the included angle between the groove bottom wall 6317 and the end of the chuck push tube 65 away from the proximal chuck cap 611 is an obtuse angle α. That is, the bottom wall 6317 of the groove is an inclined surface arranged obliquely with respect to the end of the chuck push tube 65 away from the proximal chuck cap 611. In this way, it provides guidance for the movement of the thread guide 80 into the chuck push tube 65 and also provides guidance for the pin The assembly 70 is restrained by the thread guide 80 and retracted into the chuck push tube 65 to provide guidance.
如图9所示,远端夹头主体631设通孔6313,通孔6313与近端夹头主体613中的通 道6133连通。As shown in FIG. 9, the distal chuck body 631 is provided with a through hole 6313, and the through hole 6313 communicates with the channel 6133 in the proximal chuck body 613.
夹头推管65活动穿设于近端夹头座611、近端夹头主体613中,夹头推管65固定穿设于远端夹头主体631与远端夹头帽633内。The chuck push tube 65 is movably inserted in the proximal chuck seat 611 and the proximal chuck body 613, and the chuck push tube 65 is fixedly pierced in the distal chuck body 631 and the distal chuck cap 633.
如图8所示,夹头推管65上设置侧向通孔651,侧向通孔651与凹槽6314连通,引线器80部分活动穿设于侧向通孔651并部分容置于凹槽6314中。As shown in FIG. 8, the chuck push tube 65 is provided with a lateral through hole 651, the lateral through hole 651 is in communication with the groove 6314, and the wire guide 80 is partially movably inserted through the lateral through hole 651 and partially accommodated in the groove 6314 in.
请结合参阅图3、图5、图8、图9及图10,远端夹头帽633朝向远端夹头主体631的端面(即远端夹头帽633的近端面)设有凹陷6330,该凹陷6330与所述凹槽6314对合。凹陷6330用于为插针组件70受引线器80束缚被牵拉至夹头推管65内过程中提供导向。凹陷6330的底部还设置与通孔6313连通的通道6331,即通道6113、通道6133、通孔6313及通道6331依次连通形成供插针组件70活动穿设的通道,并且通道6113、通道6133、通孔6313及通道6331均轴向对应设置。瓣膜修复缝线装置100处于穿刺状态时,插针组件70可活动穿设于通道6113、通道6133、通孔6313及通道6331。在本实施方式中,通道6331与通孔6313及凹槽6314连通。Please refer to Figure 3, Figure 5, Figure 8, Figure 9 and Figure 10, the distal end of the chuck cap 633 facing the distal end of the chuck body 631 (that is, the proximal end of the distal chuck cap 633) is provided with a recess 6330 , The recess 6330 is aligned with the groove 6314. The recess 6330 is used to provide a guide for the pin assembly 70 to be pulled into the chuck push tube 65 while being restrained by the lead guide 80. The bottom of the recess 6330 is also provided with a channel 6331 communicating with the through hole 6313, that is, the channel 6113, the channel 6133, the through hole 6313, and the channel 6331 are sequentially connected to form a channel for the pin assembly 70 to move through. The holes 6313 and the channels 6331 are axially correspondingly arranged. When the valve repair suture device 100 is in the puncture state, the needle assembly 70 can be movably inserted through the channel 6113, the channel 6133, the through hole 6313, and the channel 6331. In this embodiment, the channel 6331 communicates with the through hole 6313 and the groove 6314.
请再次参阅图3,夹持组件60还包括垫块66,垫块66与夹头推管65远离操作主体10的一端固定连接。垫块66固定收容于远端夹头63的远端夹头帽633内,垫块66固定套设于夹头推管65的远端。Please refer to FIG. 3 again. The clamping assembly 60 further includes a spacer 66, and the spacer 66 is fixedly connected to the end of the chuck push tube 65 away from the operating body 10. The spacer 66 is fixedly received in the distal chuck cap 633 of the distal chuck 63, and the spacer 66 is fixedly sleeved on the distal end of the chuck push tube 65.
在本实施方式中,垫块66上涂覆显影材料。垫块66的设置一方面可以增大夹头推管65和远端夹头63的受力面积,另一方面起到了显影的作用,以在手术中观察到瓣膜缝线器50的位置。在本实施方式中,如图7所示,垫块66的形状为半圆柱状。可以理解,不限制垫块66的形状,例如,可以采用三角形、正方形或梯形等。In this embodiment, the spacer 66 is coated with a developing material. The arrangement of the spacer 66 can increase the force-receiving area of the chuck push tube 65 and the distal chuck 63 on the one hand, and on the other hand play a role of visualization, so that the position of the valve suture device 50 can be observed during the operation. In this embodiment, as shown in FIG. 7, the shape of the spacer 66 is a semi-cylindrical shape. It can be understood that the shape of the pad 66 is not limited, for example, a triangle, a square, a trapezoid, or the like can be adopted.
可以理解,垫块66可以省略,夹头推管65直接与远端夹头帽633固定连接。It can be understood that the spacer 66 can be omitted, and the chuck push tube 65 is directly and fixedly connected to the distal chuck cap 633.
请再次参阅图7及图9,在本实施方式中,夹持组件60还包括导杆67,导杆67一端与垫块66固定连接,导杆67活动穿设于近端夹头主体613及远端夹头主体631中,导杆67与夹头推管65间隔设置。导杆67用于在夹头推管65带动远端夹头63相对近端夹头61运动时,为夹头推管65提供导向作用。Please refer to FIGS. 7 and 9 again. In this embodiment, the clamping assembly 60 further includes a guide rod 67, one end of the guide rod 67 is fixedly connected to the spacer 66, and the guide rod 67 is movably inserted through the proximal chuck body 613 and In the distal chuck main body 631, the guide rod 67 and the chuck push tube 65 are spaced apart. The guide rod 67 is used to provide a guide for the chuck push tube 65 when the chuck push tube 65 drives the distal chuck 63 to move relative to the proximal chuck 61.
在本实施方式中,导杆67的数量为两个。可以理解,不限定导杆67的数量。In this embodiment, the number of guide rods 67 is two. It can be understood that the number of guide rods 67 is not limited.
请再次参阅图9,在本实施方式中,夹持组件60还包括限位块68,限位块68固定连接于导杆67远离垫块66的一端(即导杆67的近端)。导杆67位于垫块66和限位块68之间。夹头推管65穿设于限位块68。限位块68容置于近端夹头主体613中。限位块68用于防止导杆67从近端夹头主体613中脱出。Please refer to FIG. 9 again. In this embodiment, the clamping assembly 60 further includes a limiting block 68, which is fixedly connected to the end of the guide rod 67 away from the cushion block 66 (ie, the proximal end of the guide rod 67). The guide rod 67 is located between the spacer block 66 and the limit block 68. The chuck push tube 65 penetrates through the limiting block 68. The limiting block 68 is accommodated in the proximal chuck body 613. The limiting block 68 is used to prevent the guide rod 67 from falling out of the proximal chuck body 613.
可以理解,限位块68可以省略并将导杆67设置为伸缩杆,使具有伸缩功能的导杆67直接与近端夹头主体613固定连接。It can be understood that the limiting block 68 can be omitted and the guide rod 67 can be set as a telescopic rod, so that the guide rod 67 with telescoping function is directly and fixedly connected with the proximal chuck body 613.
请参阅图11,图11为图3所示的引线器与引线控制件的立体组装示意图。Please refer to FIG. 11. FIG. 11 is a three-dimensional assembly diagram of the thread guide and the lead control member shown in FIG. 3.
引线器80包括固定连接的引线线圈81与驱动件83,驱动件83远离引线线圈81的一端与引线控制件132连接,驱动件83位于引线控制件与引线线圈81之间。通道6331与通孔6313共同形成的轴向通道位于引线线圈81内。换而言之,近端夹头61与远端夹头63内分别设有相互对齐的轴向通道供插针组件70及人工腱索200穿插,远端夹头63内的轴向通道连通凹槽6314且位于引线线圈81内。The lead wire 80 includes a lead coil 81 and a driver 83 that are fixedly connected. The end of the driver 83 away from the lead coil 81 is connected to the lead controller 132, and the driver 83 is located between the lead coil 81 and the lead coil 81. The axial passage formed by the passage 6331 and the through hole 6313 is located in the lead coil 81. In other words, the proximal chuck 61 and the distal chuck 63 are respectively provided with axial channels aligned with each other for the insertion of the needle assembly 70 and the artificial chord 200, and the axial channels in the distal chuck 63 communicate with each other. The slot 6314 is located in the lead coil 81.
如图3所示,驱动件83活动穿设于夹头推管65中。引线线圈81活动容置于远端夹头主体631与远端夹头帽633之间,引线线圈81活动穿设于侧向通孔651并收容于凹槽6314。引线线圈81用于在驱动件83于夹头推管65内朝向近端方向回撤时束缚人工腱索200。As shown in FIG. 3, the driving member 83 is movably installed in the chuck push tube 65. The lead coil 81 is movably received between the distal chuck main body 631 and the distal chuck cap 633, and the lead coil 81 is movably inserted in the lateral through hole 651 and received in the groove 6314. The lead coil 81 is used to restrain the artificial chord 200 when the driving member 83 is retracted in the chuck push tube 65 toward the proximal direction.
请参阅图12,图12为图3所示的缝线器的远端夹头主体与引线器组装在一起的示意图。Please refer to FIG. 12. FIG. 12 is a schematic diagram of the assembly of the distal chuck body of the suture device and the lead guide shown in FIG. 3.
引线线圈81包括突出部812及连接部813,连接部813固定连接于突出部812的两侧,连接部813远离突出部812的端部与驱动件83固定连接,连接部813位于突出部812与驱动件83之间。突出部812用于方便束缚人工腱索200(如图5所示),以避免人工腱索200从引线线圈81中脱落。The lead coil 81 includes a protruding portion 812 and a connecting portion 813. The connecting portion 813 is fixedly connected to both sides of the protruding portion 812. The end of the connecting portion 813 away from the protruding portion 812 is fixedly connected to the driving member 83. The connecting portion 813 is located between the protruding portion 812 and Between the driver 83. The protrusion 812 is used for facilitating the binding of the artificial chord 200 (as shown in FIG. 5 ), so as to prevent the artificial chord 200 from falling off the lead coil 81.
在本实施方式中,引线线圈81自与驱动件83的连接端朝远离此连接端的方向大致成扇形展开。引线线圈81的引线直径小于凹槽6314的深度。In this embodiment, the lead coil 81 expands in a substantially fan shape from the connecting end of the lead coil 81 to the driving element 83 in a direction away from the connecting end. The lead diameter of the lead coil 81 is smaller than the depth of the groove 6314.
在本实施方式中,突出部812的形状为半环。可以理解,不限制突出部812的形状,满足引线线圈81在收紧时锁紧人工腱索200,使人工腱索200不会从引线线圈81中脱落即可,例如,突出部812的形状可设置成三角形突出等;也可以省略突出部812。In this embodiment, the shape of the protrusion 812 is a half ring. It can be understood that the shape of the protrusion 812 is not limited, and it is sufficient to lock the artificial tendon 200 when the lead coil 81 is tightened so that the artificial tendon 200 will not fall off from the lead coil 81. For example, the shape of the protrusion 812 can be It is provided as a triangular protrusion or the like; the protrusion 812 may also be omitted.
请再次参阅图3,引线线圈81预定型处理,使引线线圈81在不受外力的状态下,引线线圈81相对驱动件83翘曲。引线线圈81相对驱动件83倾斜设置,引线线圈81与驱动件83之间的夹角β为钝角。Please refer to FIG. 3 again. The lead coil 81 is pre-shaped, so that the lead coil 81 is warped relative to the driving member 83 when the lead coil 81 is not subject to external force. The lead coil 81 is arranged obliquely with respect to the driver 83, and the included angle β between the lead coil 81 and the driver 83 is an obtuse angle.
换而言之,引线线圈81束缚人工腱索200并牵引人工腱索200朝近端方向回撤前,引线线圈81与驱动件83之间的夹角为钝角,引线线圈81贴合槽底壁6317与槽侧壁6318,如此,方便引线线圈81被撤入夹头推管65。In other words, before the lead coil 81 binds the artificial tendon 200 and pulls the artificial tendon 200 back in the proximal direction, the angle between the lead coil 81 and the driver 83 is an obtuse angle, and the lead coil 81 is attached to the bottom wall of the groove. 6317 and the side wall 6318 of the slot, so that it is convenient for the lead coil 81 to be withdrawn into the chuck push tube 65.
在本实施方式中,引线线圈81由镍钛丝制成。可以理解,不限制引线线圈81的材质。不限制引线线圈81展开的形状。In this embodiment, the lead coil 81 is made of Nitinol wire. It can be understood that the material of the lead coil 81 is not limited. The expanded shape of the lead coil 81 is not limited.
请再次参阅图3,插针组件70包括插针推管71及插针73,插针推管71与插针控制件131(如图2所示)连接,插针73位于插针推管71远离插针控制件131的一端(即插针推管71的远端),插针推管71的远端能够抵推插针73的近端,插针推管71位于插针73与插针控制件131之间。插针推管71及插针73均活动穿设于近端夹头主体613及近端夹头座611中。插针73用于穿刺瓣膜。插针73与插针推管71相邻一端用于固定连接人工腱索200,插针推管71用于推动插针73。Please refer to FIG. 3 again. The pin assembly 70 includes a pin push tube 71 and a pin 73. The pin push tube 71 is connected to the pin control part 131 (as shown in FIG. 2), and the pin 73 is located in the pin push tube 71. One end away from the pin control member 131 (that is, the distal end of the pin push tube 71), the distal end of the pin push tube 71 can push against the proximal end of the pin 73, and the pin push tube 71 is located between the pin 73 and the pin Between the control pieces 131. The pin push tube 71 and the pin 73 are movably installed in the proximal chuck body 613 and the proximal chuck seat 611. The needle 73 is used to puncture the valve. The end adjacent to the pin 73 and the pin push tube 71 is used to fix and connect the artificial tendon 200, and the pin push tube 71 is used to push the pin 73.
请参阅图13,图13为图3所示的缝线器的插针组件及人工腱索组装在一起的立体示意图。Please refer to FIG. 13, which is a three-dimensional schematic diagram of the needle assembly and artificial tendon of the suture device shown in FIG. 3 being assembled together.
插针73的外径与插针推管71的外径大致相同,以方便插针推管71推送插针73。插针73与插针推管71能够相互接触但不固定连接。可以理解,不限定插针73的外径与插针推管71的外径。The outer diameter of the pin 73 is approximately the same as the outer diameter of the pin push tube 71 to facilitate the pin push tube 71 to push the pin 73. The pin 73 and the pin push tube 71 can contact each other but are not fixedly connected. It can be understood that the outer diameter of the pin 73 and the outer diameter of the pin push tube 71 are not limited.
在本实施方式中,插针73包括一体连接的针管731和针头733,针管731靠近插针推管71设置,针头733位于针管731的远端,插针73的针管731呈管状。In this embodiment, the needle 73 includes a needle tube 731 and a needle 733 that are integrally connected. The needle tube 731 is disposed close to the needle push tube 71, the needle 733 is located at the distal end of the needle tube 731, and the needle tube 731 of the needle 73 is tubular.
插针73的针头733为斜切的尖端,相比于现有的钩状针头能够减小穿刺点,降低对瓣膜的损伤。可以理解,不限制插针73的针头733为斜切的尖端,满足利于插针73穿刺并且减小对瓣膜的损伤即可,例如,可以将插针73的针头733设置为锥形的尖端。可以理解, 不限制插针73的材质,例如,插针73的材质可以但不限于为不锈钢等。The needle 733 of the insertion needle 73 is a beveled tip, which can reduce the puncture point and reduce the damage to the valve compared with the existing hook needle. It can be understood that the needle 733 of the insert needle 73 is not limited to a beveled tip, and it is sufficient to facilitate the puncture of the insert needle 73 and reduce damage to the valve. For example, the needle 733 of the insert needle 73 can be configured as a tapered tip. It can be understood that the material of the pin 73 is not limited. For example, the material of the pin 73 may be, but is not limited to, stainless steel or the like.
在本实施方式中,插针73的数量为两个,插针推管71的数量对应为两个。In this embodiment, the number of pins 73 is two, and the number of pin push tubes 71 corresponds to two.
可以理解,不限制插针73及插针推管71的数量,例如,插针73及插针推管71的数量可以为1、3、4等。It can be understood that the number of the pins 73 and the pin push tube 71 is not limited, for example, the number of the pins 73 and the pin push tube 71 can be 1, 3, 4, and so on.
如图14所示,插针组件70还包括插针导管75(亦可参阅图3),插针导管75固定穿设于近端夹头主体613及近端夹头座611中。插针73及插针推管71能够活动地穿设于插针导管75中。插针导管75用于对插针73和插针推管71的运动进行导向。As shown in FIG. 14, the pin assembly 70 further includes a pin catheter 75 (see also FIG. 3 ). The pin catheter 75 is fixedly inserted into the proximal chuck body 613 and the proximal chuck seat 611. The insertion needle 73 and the insertion needle push tube 71 can be movably inserted into the insertion needle catheter 75. The pin guide 75 is used to guide the movement of the pin 73 and the pin push tube 71.
可以理解,插针导管75可以省略。例如,近端夹头主体613的通孔6133内壁能够与插针推管71和插针73的外壁配合,以满足对插针73和插针推管71于近端夹头61的运动进行导向即可。It is understood that the needle catheter 75 can be omitted. For example, the inner wall of the through hole 6133 of the proximal chuck body 613 can be matched with the outer walls of the pin push tube 71 and the pin 73 to guide the movement of the pin 73 and the pin push tube 71 in the proximal chuck 61 That's it.
请参阅图15,图15为插针组件的剖面图。在本实施方式中,插针推管71远端的横截面大致成半包的C型凹槽结构,用于容置人工腱索200的端部。如此,以减小人工腱索200暴露于插针推管71之外时对穿刺瓣膜的阻碍,亦方便将人工腱索200放置于插针推管71内。可以理解,不限制插针推管71横截面的形状,例如,可以但不限于设置成“匚”字型、“口”字型、V型等。Please refer to Figure 15. Figure 15 is a cross-sectional view of the pin assembly. In this embodiment, the cross section of the distal end of the needle push tube 71 is roughly a half-packed C-shaped groove structure for accommodating the end of the artificial chord 200. In this way, the obstacle to the puncture valve when the artificial chord 200 is exposed outside the needle insertion tube 71 is reduced, and it is also convenient to place the artificial chord 200 in the needle insertion tube 71. It can be understood that the shape of the cross section of the pin push tube 71 is not limited. For example, it can be set in a "匚" shape, a "mouth" shape, a V shape, etc., but is not limited to.
请参阅图16及图17,图16为图6所示的缝线器的插针组件及人工腱索组装在一起的立体示意图,图17为图16的插针组件及人工腱索另一视角的示意图。Please refer to Figure 16 and Figure 17. Figure 16 is a perspective view of the needle assembly and artificial tendon of the suture device shown in Figure 6 assembled together, and Figure 17 is another perspective of the needle assembly and artificial tendon of Figure 16 Schematic diagram.
在插针控制件131(如图2所示)的作用下,插针推管71推动插针73朝远离插针控制件131的方向移动。Under the action of the pin control member 131 (as shown in FIG. 2 ), the pin push tube 71 pushes the pin 73 to move away from the pin control member 131.
请参阅图18,图18为第一实施方式提供的人工腱索与插针组装在一起的立体示意图。Please refer to FIG. 18. FIG. 18 is a perspective view of the artificial chord and the pin assembled together according to the first embodiment.
在本实施方式中,插针73的数量为两个。人工腱索200包括第一固定端201、第二固定端203及腱索主体205。腱索主体205固定连接于第一固定端201和第二固定端203之间。第一固定端201及第二固定端203分别与一个插针73固定连接。腱索主体205用于替代功能不正常的腱索。如图3所示,人工腱索200容置于近端夹头主体613及近端夹头座611内。In this embodiment, the number of pins 73 is two. The artificial chord 200 includes a first fixed end 201, a second fixed end 203 and a chord main body 205. The chord main body 205 is fixedly connected between the first fixed end 201 and the second fixed end 203. The first fixed end 201 and the second fixed end 203 are respectively fixedly connected to a pin 73. The chordae main body 205 is used to replace the dysfunctional chordae. As shown in FIG. 3, the artificial chord 200 is accommodated in the proximal chuck body 613 and the proximal chuck seat 611.
在本实施方式中,腱索主体205弯折为“U”型,并且,第一固定端201、第二固定端203分别与插针73固定连接。如此,当插针73牵引第一固定端201及第二固定端203自心房侧向心室侧穿刺瓣膜后,腱索主体205的弯折部位最终被牵拉至接触瓣膜靠近心房的一侧,使人工腱索200的部分被限位于所述瓣膜靠近心房的一侧,为后续的人工腱索200沿心室侧延伸并固定至心室壁或乳头肌提供起始端。In this embodiment, the chord main body 205 is bent into a "U" shape, and the first fixed end 201 and the second fixed end 203 are respectively fixedly connected to the pin 73. In this way, when the first fixed end 201 and the second fixed end 203 are drawn by the needle 73 to puncture the valve from the atrium side to the ventricle side, the bent part of the chordae 205 is finally pulled to the side that contacts the valve near the atrium, so that A part of the artificial chordae 200 is confined to the side of the valve close to the atrium, and provides a starting end for the subsequent artificial chordae 200 to extend along the side of the ventricle and be fixed to the ventricular wall or papillary muscle.
在本实施方式中,一条人工腱索200经对折后的两端即为第一固定端201与第二固定端203,其余部分为腱索主体205,腱索主体205被收纳置于所述缝线储藏管6119内。人工腱索200的两端分别穿设于一针管731,通过夹线钳夹紧相应的针管731分别使第一固定端201、第二固定端203对应与一插针73固定连接。可以理解,不限制人工腱索200与插针73的连接方式,例如,可以但不限于通过胶合连接等。In this embodiment, the two ends of an artificial tendon 200 after being folded in half are the first fixed end 201 and the second fixed end 203, and the remaining part is the tendon main body 205, and the tendon main body 205 is accommodated in the slit. Line storage tube 6119. Two ends of the artificial tendon 200 are respectively threaded through a needle tube 731, and the corresponding needle tube 731 is clamped by a wire clamp to respectively fix the first fixed end 201 and the second fixed end 203 with a pin 73 correspondingly. It can be understood that the connection manner of the artificial chord 200 and the pin 73 is not limited, for example, the connection can be but not limited to by gluing.
在本实施方式中,人工腱索200选用缝线,缝线可以为光滑材质制成,例如聚四氟乙烯(polytetrafluoroethylene,简称PTFE),也可以为不光滑材质制成,例如涤纶树脂(Polyethylene terephthalate,简称PET)。当缝线由PTFE等光滑材质制成时,夹线钳需要 以较大力度夹紧插针73与缝线,使得当通过引线线圈81拉动人工腱索200时,插针73近端端面卡住引线线圈81,引线线圈81带动人工腱索200与插针73一同经夹头推管65撤出体外;当人工腱索200为PET等较不光滑的材质制成时,夹线钳以较小力度夹紧插针73与人工腱索200,远端夹头帽633内的通道6331待插针73插入时,与插针73形成紧配合,引线线圈81拉动人工腱索200时,人工腱索200可与插针73分离,人工腱索200与引线线圈81之间的摩擦力较大,引线线圈81仅带动人工腱索200通过夹头推管65撤出体外。In this embodiment, the artificial chord 200 is made of sutures. The sutures can be made of a smooth material, such as polytetrafluoroethylene (PTFE), or a non-smooth material, such as polyester resin (polyethylene terephthalate). , Referred to as PET). When the suture is made of smooth material such as PTFE, the crimping pliers need to clamp the pin 73 and the suture with greater force, so that when the artificial tendon 200 is pulled by the lead coil 81, the proximal end of the pin 73 is stuck The lead coil 81, the lead coil 81 drives the artificial tendon 200 together with the pin 73 to be withdrawn from the body through the chuck push tube 65; when the artificial tendon 200 is made of a relatively non-smooth material such as PET, the clamp is smaller Clamp the pin 73 and the artificial tendon 200 with force. The channel 6331 in the distal chuck cap 633 will form a tight fit with the pin 73 when the pin 73 is inserted. When the artificial tendon 200 is pulled by the lead loop 81, the artificial tendon 200 can be separated from the pin 73, and the friction between the artificial tendon 200 and the lead coil 81 is relatively large, and the lead coil 81 only drives the artificial tendon 200 to withdraw from the body through the chuck push tube 65.
可以理解,上述两种材料仅仅为示例性的,不构成对本申请的限定,人工腱索200还可以由其他材质制成。It can be understood that the above two materials are only exemplary and do not constitute a limitation of the present application. The artificial tendon 200 may also be made of other materials.
在本实施方式中,人工腱索200上穿设有垫片210,垫片210上设置两通孔211分别供所述第一固定端201与第二固定端203穿过,垫片210用于增大腱索主体205弯折部位与瓣膜接触时的接触面积,以减少对瓣膜的损伤。换而言之,人工腱索200上穿装垫片210,垫片210活动容置于近端夹头61内,所述人工腱索200的部分被限位于瓣膜靠近心房的一侧时,垫片210位于所述人工腱索200的部分与瓣膜靠近心房的一侧之间。In this embodiment, a gasket 210 is passed through the artificial tendon 200, and the gasket 210 is provided with two through holes 211 for the first fixed end 201 and the second fixed end 203 to pass through, and the gasket 210 is used for The contact area when the bending part of the chordae main body 205 contacts the valve is increased to reduce damage to the valve. In other words, a spacer 210 is worn on the artificial chord 200, and the spacer 210 is movably accommodated in the proximal chuck 61. When the part of the artificial chord 200 is confined to the side of the valve close to the atrium, the pad 210 The sheet 210 is located between the part of the artificial chordae 200 and the side of the valve close to the atrium.
在本实施方式中,垫片210设置向腱索主体205的弯折部位突出的弧度,使垫片210更好地贴合瓣膜。可以理解,垫片210的弧度以最大程度贴合瓣膜为佳。In this embodiment, the gasket 210 is provided with an arc protruding toward the bending part of the chordae main body 205, so that the gasket 210 can better fit the valve. It can be understood that the curvature of the gasket 210 is better to fit the valve to the greatest extent.
可以理解,不限制垫片210的材质,例如,垫片210的材质可以但不限于为涤纶布、聚四氟乙烯(Polytetrafluoroethylene,简称PTFE)、涤纶树脂(Polyethylene terephthalate,简称PET)等。可以理解,垫片210可以省略。It can be understood that the material of the gasket 210 is not limited. For example, the material of the gasket 210 may be, but not limited to, polyester cloth, polytetrafluoroethylene (PTFE), polyester resin (polyethylene terephthalate, PET), etc. It can be understood that the gasket 210 may be omitted.
在本实施方式中,结合图8、图9与图13,近端夹头主体613还设置容置部6134,用于容置垫片210。容置部6134与供插针组件70穿设的通孔6133连通为一体,优选垫片210以平行于轴向的姿态容置在所述容置部6134内。In this embodiment, in conjunction with FIG. 8, FIG. 9 and FIG. 13, the proximal chuck main body 613 is further provided with a receiving portion 6134 for receiving the gasket 210. The accommodating portion 6134 communicates with the through hole 6133 through which the pin assembly 70 is inserted as a whole. Preferably, the gasket 210 is accommodated in the accommodating portion 6134 in a posture parallel to the axial direction.
如图8所示,在瓣膜修复缝线装置100的具体使用过程中,插针73在插针推管71的推动下,牵引人工腱索200穿刺瓣膜并穿过引线线圈81,引线线圈81在驱动件83的带动下后撤,进而收紧以束缚插针73及人工腱索200并带动插针73及人工腱索200后撤,直至垫片210贴合瓣膜靠近心房的一侧,使人工腱索200部分被限位于瓣膜靠近心房的一侧。As shown in Figure 8, during the specific use process of the valve repair suture device 100, the needle 73 is pushed by the needle push tube 71 to pull the artificial chord 200 to puncture the valve and pass through the lead coil 81. The lead coil 81 is in Driven by the driving member 83, it withdraws downwards, and then tightens to restrain the needle 73 and the artificial chord 200, and drives the needle 73 and the artificial chord 200 to withdraw until the gasket 210 fits the side of the valve close to the atrium, so that the artificial The chordae 200 portion is confined to the side of the valve near the atrium.
请再次结合参阅图2、图3及图9,瓣膜修复缝线装置100还包括探针90,探针90活动穿设于近端夹头主体611及近端夹头座613,探针90位于夹头推管65及插针组件70之间,探针90与夹头推管65间隔设置。操作主体10上设置探针控制件135,探针控制件135与探针90的近端连接,用于控制探针90运动。Please refer to Figure 2, Figure 3 and Figure 9 again, the valve repair suture device 100 further includes a probe 90, which is movably inserted through the proximal chuck body 611 and the proximal chuck seat 613, and the probe 90 is located Between the chuck push tube 65 and the pin assembly 70, the probe 90 and the chuck push tube 65 are spaced apart. The operating body 10 is provided with a probe control member 135 which is connected to the proximal end of the probe 90 for controlling the movement of the probe 90.
鞘管30固定连接于操作主体10与近端夹头座611之间,用于容置缝线储藏管6119、插针组件70、探针90、插针组件70及夹头推管65。The sheath 30 is fixedly connected between the operating body 10 and the proximal chuck base 611, and is used for accommodating the suture storage tube 6119, the needle assembly 70, the probe 90, the needle assembly 70 and the chuck push tube 65.
请参阅图19,图19为图2所示的瓣膜修复缝线装置的鞘管的截面示意图。Please refer to FIG. 19, which is a schematic cross-sectional view of the sheath of the valve repair suture device shown in FIG. 2.
缝线储藏管6119穿设于鞘管30中,插针导管75穿设于鞘管30中,探针90活动穿设于鞘管30中,夹头推管65活动穿设于鞘管30中,缝线储藏管6119、插针导管75、探针90与夹头推管65在鞘管30内均间隔设置。The suture storage tube 6119 is inserted through the sheath 30, the needle catheter 75 is inserted through the sheath 30, the probe 90 is movably inserted through the sheath 30, and the chuck push tube 65 is movably inserted through the sheath 30 , The suture storage tube 6119, the needle catheter 75, the probe 90, and the chuck push tube 65 are all spaced apart in the sheath 30.
可以理解,不限制鞘管30的横截面大致为圆形;不限制鞘管30沿其轴向的长度,其长度满足手术所需即可。It can be understood that the cross-section of the sheath tube 30 is not restricted to be substantially circular; the length of the sheath tube 30 along its axial direction is not restricted, and the length of the sheath tube 30 is only required to meet the operation requirements.
如图3所示,近端夹头座611的径向尺寸自近端至远端由适应鞘管30逐渐增大为适应近端夹头主体613,为了配合近端夹头座611自近端至远端的尺寸变化,插针推管71设有适应近端夹头座611的尺寸变化的倾斜段。推管通道75设有适应近端夹头座611的尺寸变化的倾斜段,夹头推管65也设有适应近端夹头座611的尺寸变化的倾斜段。As shown in FIG. 3, the radial dimension of the proximal chuck holder 611 gradually increases from the proximal end to the distal end from the adaptable sheath 30 to accommodate the proximal chuck body 613, in order to match the proximal chuck holder 611 from the proximal end When the size of the distal end changes, the needle push tube 71 is provided with an inclined section adapted to the size change of the proximal collet holder 611. The push tube passage 75 is provided with an inclined section adapted to the size change of the proximal chuck seat 611, and the chuck push tube 65 is also provided with an inclined section adapted to the size change of the proximal chuck seat 611.
在一应用场景中,将该瓣膜修复缝线装置用于治疗三尖瓣(如图1所示TV)返流。请参阅图20,瓣膜缝线器50经导管途径即通过下腔静脉(如图20所示IVC)依次进入右心房(如图20所示RA)与右心室(如图20所示RV),近端夹头61位于心房侧、远端夹头63位于心室侧,二者夹持瓣膜。瓣膜缝线器50的插针73穿刺瓣膜前,插针组件70与人工腱索200容置在近端夹头61的一侧,引线器80的引线线圈81容置在远端夹头63的凹槽6314内。插针组件70牵引人工腱索200(如图3所示)自心房侧向心室侧穿刺瓣膜后从引线器80穿出,驱动件83于夹头推管65内朝向近端方向回撤,驱动引线线圈81收紧而束缚人工腱索200并牵引人工腱索200与插针73进入夹头推管65,使人工腱索200的部分被限位在瓣膜靠近心房的一侧,人工腱索200的得以从瓣膜靠近心室的一侧穿出并能够朝心室侧延伸,后续通过锚定操作便能够将人工腱索200远离瓣膜的部分固定至心室侧的心室壁或乳头肌上,从而实现经导管途径的人工腱索植入及心脏瓣膜修复。In an application scenario, the valve repair suture device is used to treat tricuspid regurgitation (TV as shown in FIG. 1). Please refer to Fig. 20, the valve suture device 50 enters the right atrium (RA shown in Fig. 20) and the right ventricle (RV shown in Fig. 20) sequentially through the inferior vena cava (IVC as shown in Fig. 20) via the catheter route. The proximal chuck 61 is located on the atrial side and the distal chuck 63 is located on the ventricle side, and the two clamp the valve. Before the needle 73 of the valve suture device 50 punctures the valve, the needle assembly 70 and the artificial chord 200 are accommodated on one side of the proximal chuck 61, and the lead coil 81 of the lead device 80 is accommodated in the distal chuck 63 In the groove 6314. The needle assembly 70 pulls the artificial chord 200 (as shown in Figure 3) from the atrium side to the ventricle side to puncture the valve and then pass through the introducer 80. The drive member 83 is retracted in the chuck push tube 65 toward the proximal direction to drive The lead coil 81 tightens and binds the artificial chord 200 and pulls the artificial chord 200 and the pin 73 into the chuck push tube 65, so that the part of the artificial chord 200 is limited to the side of the valve near the atrium. The artificial chord 200 The part of the artificial chordae 200 can be penetrated from the side of the valve close to the ventricle and can extend toward the ventricle side, and then the part of the artificial chordae 200 away from the valve can be fixed to the ventricular wall or papillary muscle on the side of the ventricle through an anchoring operation, thereby achieving transcatheter Way of artificial chord implantation and heart valve repair.
在一应用场景中,瓣膜缝线器50经导管途径治疗三尖瓣(如图1所示TV)返流还可以通过上腔静脉(如图20所示SVC)依次进入右心房(如图20所示RA)与右心室(如图20所示RV),以到达三尖瓣瓣膜位置。In an application scenario, the valve suture device 50 is used to treat the tricuspid valve (TV as shown in Figure 1) regurgitation through the catheter approach, and it can also enter the right atrium through the superior vena cava (SVC as shown in Figure 20) in turn (as shown in Figure 20). Show RA) and right ventricle (RV shown in Figure 20) to reach the tricuspid valve position.
在一应用场景中,将瓣膜修复缝线装置用于治疗二尖瓣(如图1所示MV)返流。请参阅图21所示,瓣膜缝线器50经导管途径即通过下腔静脉(如图21所示IVC)先进入右心房(如图21所示RA),之后穿刺卵圆窝(如图21所示FO),依次进入左心房(如图21所示LA)和左心室(如图21所示LV),以到达二尖瓣瓣膜位置。In an application scenario, a valve repair suture device is used to treat mitral valve regurgitation (MV as shown in Figure 1). Please refer to Figure 21, the valve suture device 50 passes through the inferior vena cava (IVC as shown in Figure 21) through the catheter to enter the right atrium (RA as shown in Figure 21), and then punctures the fossa ovale (Figure 21) Shown FO), enter the left atrium (LA as shown in Figure 21) and left ventricle (LV as shown in Figure 21) in sequence to reach the position of the mitral valve.
在一应用场景中,瓣膜缝线器50经导管途径治疗二尖瓣(如图1所示MV)返流还可以通过上腔静脉(如图21所示SVC)先进入右心房(如图21所示RA),之后穿刺卵圆窝(如图21所示FO),依次进入左心房(如图21所示LA)和左心室(如图21所示LV),以到达二尖瓣瓣膜位置。In an application scenario, the valve suture device 50 is used to treat the mitral valve (MV as shown in Figure 1) regurgitation through the catheter approach, and it can also enter the right atrium through the superior vena cava (SVC as shown in Figure 21) first (as shown in Figure 21). Show RA), then puncture the fossa ovale (FO as shown in Figure 21), enter the left atrium (LA as shown in Figure 21) and left ventricle (LV as shown in Figure 21) in order to reach the position of the mitral valve .
在具体实施方式中,如图20所示,以治疗三尖瓣(如图1所示TV)为例,介绍瓣膜修复缝线装置的具体使用过程。将瓣膜修复缝线装置100的瓣膜缝线器50经下腔静脉(如图20所示IVC)依次进入右心房(如图20所示RA)与右心室(如图20所示RV),近端夹头61位于心房侧,远端夹头63位于心室侧。In a specific embodiment, as shown in FIG. 20, taking the treatment of the tricuspid valve (TV shown in FIG. 1) as an example, the specific use process of the valve repair suture device is introduced. Insert the valve suture device 50 of the valve repair suture device 100 through the inferior vena cava (IVC as shown in FIG. 20) into the right atrium (RA as shown in FIG. 20) and the right ventricle (RV as shown in FIG. 20) in turn. The end chuck 61 is located on the atrium side, and the distal chuck 63 is located on the ventricle side.
如图22所示,近端夹头61与远端夹头63在夹头推管65的带动下相对打开。近端夹头61与远端夹头63在夹头推管65的带动下夹紧瓣膜(如图22所示V)后,通过探针90探测以确认瓣膜是否被有效夹持。As shown in FIG. 22, the proximal chuck 61 and the distal chuck 63 are relatively opened under the drive of the chuck push tube 65. After the proximal chuck 61 and the distal chuck 63 clamp the valve under the drive of the chuck push tube 65 (shown as V in FIG. 22), they are detected by the probe 90 to confirm whether the valve is effectively clamped.
如图23和图24所示,当探针90确认瓣膜已被有效夹持,插针73在插针推管71(如图3所示)的推动下从心房侧向心室侧穿刺。插针73带动人工腱索200穿刺瓣膜并从引线线圈81中穿出,插针73及人工腱索200进入远端夹头63内。然后后撤插针推管71,插针73与插针推管71分离。As shown in FIGS. 23 and 24, when the probe 90 confirms that the valve has been effectively clamped, the needle 73 is pushed by the needle push tube 71 (as shown in FIG. 3) to puncture from the atrial side to the ventricle side. The insert needle 73 drives the artificial chordae 200 to puncture the valve and pass through the lead coil 81, and the insert needle 73 and the artificial chordae 200 enter the distal chuck 63. Then the pin push tube 71 is withdrawn, and the pin 73 is separated from the pin push tube 71.
如图25和图26所示,驱动件83朝近端方向回撤,引线线圈81在驱动件83的带动下 逐步收紧、牵动人工腱索200与插针73进入夹头推管65,插针73沿所述凹陷6330的底壁(如图10所示)向夹头推管65内滑动。As shown in Figures 25 and 26, the driving member 83 is retracted toward the proximal direction, and the lead coil 81 is gradually tightened under the driving of the driving member 83, pulling the artificial tendon 200 and the pin 73 into the chuck push tube 65 and inserting The needle 73 slides into the chuck push tube 65 along the bottom wall of the recess 6330 (as shown in FIG. 10).
如图27和图28所示,引线线圈81继续回撤将人工腱索200与插针73沿夹头推管65朝近端方向撤出,人工腱索200的腱索主体205将垫片210从容置部6134(如图18所示)中带出,使垫片210与瓣膜靠近心房的一侧接触,并且使人工腱索200的弯折部分被限位在瓣膜靠近心房的一侧。As shown in Figures 27 and 28, the lead coil 81 continues to withdraw to withdraw the artificial chord 200 and the pin 73 along the chuck push tube 65 toward the proximal direction, and the chord main body 205 of the artificial chord 200 shim 210 Take out from the accommodating portion 6134 (as shown in FIG. 18), the gasket 210 is brought into contact with the side of the valve close to the atrium, and the bending part of the artificial chordae 200 is limited to the side of the valve close to the atrium.
如图29所示,垫片210接触瓣膜位于心房侧的表面,即垫片210位于心房侧,使人工腱索200从心室侧穿出并朝心室侧延伸,后续撤出瓣膜缝线器50(如图4所示)及鞘管30(如图4所示)。As shown in Figure 29, the gasket 210 contacts the surface of the valve on the atrial side, that is, the gasket 210 is located on the atrial side, so that the artificial chordae 200 is passed out from the ventricular side and extends toward the ventricular side, and then the valve suture device 50 ( As shown in Figure 4) and sheath 30 (as shown in Figure 4).
如图30所示,由于腱索主体205的弯折部位最终被牵拉至接触瓣膜靠近心房的一侧,使人工腱索200的部分被限位于所述瓣膜靠近心房的一侧,为人工腱索200沿心室侧延伸提供了起始端,调整人工腱索200使得返流处于最轻状态后,将人工腱索200远离瓣膜的部分通过锚定件600固定于心室壁或乳头肌上,即完成了人工腱索200的植入。As shown in Fig. 30, since the bent part of the chordae main body 205 is finally pulled to contact the side of the valve near the atrium, the part of the artificial chord 200 is limited to the side of the valve near the atrium, which is an artificial tendon. The cord 200 extends along the side of the ventricle to provide the starting end. After adjusting the artificial chord 200 to make the regurgitation in the lightest state, fix the part of the artificial chord 200 away from the valve to the ventricular wall or papillary muscle through the anchor 600 to complete it. The implantation of the artificial tendon 200 is completed.
第二实施方式Second embodiment
请参阅图31,图31为本申请第二实施方式提供的人工腱索与插针组装在一起的结构示意图。Please refer to FIG. 31. FIG. 31 is a schematic diagram of the assembly of the artificial chord and the pin provided by the second embodiment of the application.
第二实施方式提供的人工腱索300包括第一固定端301、第二固定端303、腱索主体305及限位件307。腱索主体305固定连接于第一固定端301和第二固定端303之间,腱索主体305上穿设垫片310。第二固定端303与插针73固定连接,第一固定端301远离腱索主体305的一端与限位件307固定连接。垫片310上设置通孔311,腱索主体305穿设于通孔311中。在本实施方式中,限位件307为球状体,限位件307的直径大于通孔311的直径。The artificial chord 300 provided in the second embodiment includes a first fixed end 301, a second fixed end 303, a chord main body 305 and a stopper 307. The chord main body 305 is fixedly connected between the first fixing end 301 and the second fixing end 303, and a gasket 310 is passed through the main chord 305. The second fixed end 303 is fixedly connected to the pin 73, and the end of the first fixed end 301 away from the tendon main body 305 is fixedly connected to the limiting member 307. The gasket 310 is provided with a through hole 311, and the chord main body 305 is inserted through the through hole 311. In this embodiment, the limiting member 307 is a spherical body, and the diameter of the limiting member 307 is larger than the diameter of the through hole 311.
在具体实施方式中,插针73带动人工腱索300的腱索主体305自心房侧向心室侧穿刺瓣膜,当引线器带动插针73及人工腱索300后撤结束后,人工腱索300的限位件307压紧垫片310,使垫片310与瓣膜接触,从而将人工腱索300的第一固定端301限位在瓣膜靠近心房的一侧,以为人工腱索200沿心室侧延伸提供起始端。In a specific embodiment, the insertion needle 73 drives the chordal main body 305 of the artificial chordal 300 to puncture the valve from the atrium side to the ventricular side. The stopper 307 compresses the spacer 310 so that the spacer 310 is in contact with the valve, thereby limiting the first fixed end 301 of the artificial chordae 300 on the side of the valve close to the atrium, so that the artificial chordae 200 extends along the side of the ventricle. Starting end.
第三实施方式The third embodiment
如图32所示,图32为本申请第三实施方式提供的瓣膜修复缝线装置的立体组装示意图。As shown in FIG. 32, FIG. 32 is a three-dimensional assembly diagram of the valve repair suture device provided by the third embodiment of the application.
瓣膜修复缝线装置400包括与操作主体10固定连接的基座90,用于承载操作主体10。The valve repair suture device 400 includes a base 90 fixedly connected to the operating body 10 and used to carry the operating body 10.
可以理解,基座90可以省略,改用人手握持操作主体10。It can be understood that the base 90 can be omitted, and the operating body 10 can be held by human hands instead.
以上所揭露的仅为本发明较佳实施方式而已,当然不能以此来限定本发明之权利范围,因此依本发明权利要求所作的等同变化,仍属本发明所涵盖的范围。The above-disclosed are only the preferred embodiments of the present invention, which of course cannot be used to limit the scope of rights of the present invention. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope of the present invention.

Claims (20)

  1. 一种瓣膜缝线器,用于植入人工腱索,其特征在于,包括夹持组件、插针组件及引线器;所述夹持组件包括近端夹头、夹头推管与远端夹头,所述夹头推管活动穿设于所述近端夹头内并固定连接所述远端夹头,所述夹头推管用于带动所述远端夹头相对所述近端夹头运动,以夹持或放松瓣膜;所述插针组件活动穿设于所述近端夹头内并连接被容纳于所述近端夹头内的人工腱索,所述引线器活动穿设于所述夹头推管及所述远端夹头内,所述插针组件用于牵引所述人工腱索自心房侧向心室侧穿刺瓣膜并穿入所述引线器,所述引线器用于束缚所述人工腱索并牵引所述人工腱索进入所述夹头推管并朝近端方向回撤,以使得所述人工腱索的部分被限位于所述瓣膜靠近心房的一侧。A valve suture device for implanting artificial chordae, which is characterized by comprising a clamping assembly, a needle assembly and a lead guide; the clamping assembly includes a proximal clamp, a clamp push tube and a distal clamp The chuck push tube is movably inserted in the proximal chuck and fixedly connected to the distal chuck, and the chuck push tube is used to drive the distal chuck relative to the proximal chuck Move to clamp or loosen the valve; the needle assembly is movably inserted into the proximal chuck and connected to the artificial chord which is contained in the proximal chuck, and the guide is movably inserted in In the chuck push tube and the distal chuck, the insertion needle assembly is used to pull the artificial chordae from the atrium side to the ventricle side to puncture the valve and penetrate into the lead guide, and the lead guide is used for binding The artificial chordae is pulled into the chuck push tube and withdrawn toward the proximal direction, so that the part of the artificial chordae is limited to the side of the valve close to the atrium.
  2. 如权利要求1所述的瓣膜缝线器,其特征在于,所述引线器包括驱动件及引线线圈,所述引线线圈固定连接所述驱动件的远端,所述驱动件活动穿设于所述夹头推管中,所述引线线圈活动容置于所述远端夹头内;所述驱动件于所述夹头推管内朝向近端方向回撤时,驱动所述引线线圈束缚所述人工腱索并牵引所述人工腱索朝近端方向回撤。The valve suture device according to claim 1, wherein the lead guide comprises a driver and a lead coil, the lead coil is fixedly connected to the distal end of the driver, and the driver is movably installed on the In the chuck push tube, the lead coil is movably accommodated in the distal chuck; when the drive member retracts toward the proximal direction in the chuck push tube, the lead coil is driven to restrain the The artificial tendon is pulled and the artificial tendon is pulled back toward the proximal direction.
  3. 如权利要求2所述的瓣膜缝线器,其特征在于,所述引线线圈包括突出部及与所述突出部两侧固定连接的连接部,所述连接部远离所述突出部的端部与所述驱动件固定连接,所述突出部用于束缚所述人工腱索。The valve suture device according to claim 2, wherein the lead coil comprises a protrusion and a connecting part fixedly connected to both sides of the protrusion, and the connecting part is far away from the end of the protrusion and The driving member is fixedly connected, and the protrusion is used to bind the artificial tendon.
  4. 如权利要求2所述的瓣膜缝线器,其特征在于,所述引线线圈经预定型处理,所述引线线圈束缚所述人工腱索并牵引所述人工腱索朝近端方向回撤前,所述引线线圈与所述驱动件之间的夹角为钝角。The valve suture device according to claim 2, wherein the lead coil is subjected to a predetermined type treatment, and the lead coil binds the artificial chordae and pulls the artificial chordae before withdrawing in the proximal direction, The included angle between the lead coil and the driving element is an obtuse angle.
  5. 如权利要求2所述的瓣膜缝线器,其特征在于,所述远端夹头包括远端夹头主体及固定连接所述远端夹头主体的远端夹头帽,所述远端夹头帽与所述夹头推管的远端固定连接,所述远端夹头主体位于所述远端夹头帽与所述近端夹头之间,所述引线线圈活动容置于所述远端夹头主体与所述远端夹头帽之间。The valve suture device according to claim 2, wherein the distal chuck comprises a distal chuck body and a distal chuck cap fixedly connected to the distal chuck body, and the distal chuck The head cap is fixedly connected to the distal end of the chuck push tube, the distal chuck body is located between the distal chuck cap and the proximal chuck, and the lead coil is movably accommodated in the Between the distal chuck body and the distal chuck cap.
  6. 如权利要求5所述的瓣膜缝线器,其特征在于,所述远端夹头主体靠近所述远端夹头帽的一侧设有凹槽,所述引线线圈活动容置于所述凹槽内。The valve suture device according to claim 5, wherein the distal chuck main body is provided with a groove on a side close to the distal chuck cap, and the lead coil is movably received in the concave内槽。 In the slot.
  7. 如权利要求6所述的瓣膜缝线器,其特征在于,所述凹槽包括槽底壁及与所述槽底壁连接的槽侧壁,所述槽底壁与所述远端夹头帽相对设置,所述引线线圈与所述槽底壁接触,所述槽底壁设有通孔,所述夹头推管活动穿设于所述槽底壁的所述通孔,所述夹头推管靠近所述远端夹头帽的部分开设有侧向通孔,所述侧向通孔与所述凹槽连通,所述引线线圈活动穿设于所述侧向通孔。The valve suture device according to claim 6, wherein the groove comprises a groove bottom wall and a groove side wall connected to the groove bottom wall, and the groove bottom wall and the distal collet cap Oppositely arranged, the lead coil is in contact with the bottom wall of the groove, the bottom wall of the groove is provided with a through hole, the chuck push tube movably penetrates the through hole of the bottom wall of the groove, and the chuck A part of the push tube close to the distal end chuck cap is provided with a lateral through hole, the lateral through hole communicates with the groove, and the lead coil is movably inserted through the lateral through hole.
  8. 如权利要求7所述的瓣膜缝线器,其特征在于,所述槽底壁相对所述夹头推管倾斜设置,所述槽底壁与所述夹头推管远离所述远端夹头帽的一端之间的夹角为钝角。The valve suture device according to claim 7, wherein the bottom wall of the groove is arranged obliquely with respect to the push tube of the chuck, and the bottom wall of the groove and the push tube of the chuck are away from the distal chuck. The angle between the ends of the cap is an obtuse angle.
  9. 如权利要求6所述的瓣膜缝线器,其特征在于,所述近端夹头与所述远端夹头主体内分别设有相互对齐的轴向通道供所述插针组件及所述人工腱索穿插,所述远端夹头主体内的所述轴向通道连通所述凹槽且位于所述引线线圈内。The valve suture device according to claim 6, wherein the proximal chuck and the distal chuck body are respectively provided with axial channels aligned with each other for the insertion needle assembly and the artificial The chordae is inserted, and the axial channel in the distal chuck body communicates with the groove and is located in the lead coil.
  10. 如权利要求5所述的瓣膜缝线器,其特征在于,所述远端夹头主体靠近所述近端夹头的一侧包括相对所述夹头推管倾斜设置的第一夹持面,所述近端夹头靠近所述远端夹头的一侧包括相对所述夹头推管倾斜设置的第二夹持面,所述第一夹持面与所述第二夹持 面相互配合。The valve suture device according to claim 5, wherein the side of the distal chuck main body close to the proximal chuck includes a first clamping surface that is arranged obliquely with respect to the chuck push tube, A side of the proximal chuck close to the distal chuck includes a second clamping surface arranged obliquely with respect to the chuck push tube, and the first clamping surface and the second clamping surface cooperate with each other .
  11. 如权利要求1所述的瓣膜缝线器,其特征在于,所述插针组件包括插针推管及插针,所述插针推管及所述插针均活动穿设于所述近端夹头内,所述插针推管的远端抵推所述插针的近端,所述插针连接所述人工腱索,所述插针推管用于推动所述插针。The valve suture device according to claim 1, wherein the needle assembly includes a needle push tube and a needle, and the needle push tube and the needle are both movably pierced through the proximal end In the chuck, the distal end of the pin push tube pushes against the proximal end of the pin, the pin is connected to the artificial chord, and the pin push tube is used to push the pin.
  12. 如权利要求11所述的瓣膜缝线器,其特征在于,所述插针组件还包括插针导管,所述插针导管固定穿设于所述近端夹头内,所述插针及插针推管可活动穿设于所述插针导管中。The valve suture device of claim 11, wherein the needle assembly further comprises a needle catheter, the needle catheter is fixedly inserted into the proximal chuck, and the needle and the insert The needle pushing tube can be movably inserted into the needle catheter.
  13. 如权利要求1所述的瓣膜缝线器,其特征在于,所述人工腱索上穿装垫片,所述垫片活动容置于所述近端夹头内,所述人工腱索的部分被限位于所述瓣膜靠近心房的一侧时,所述垫片位于所述人工腱索的部分与所述瓣膜靠近心房的一侧之间。The valve suture device according to claim 1, wherein a gasket is worn on the artificial chord, and the gasket is movably accommodated in the proximal chuck, and a part of the artificial chord When confined to the side of the valve close to the atrium, the spacer is located between the part of the artificial chordae and the side of the valve close to the atrium.
  14. 如权利要求1所述的瓣膜缝线器,其特征在于,所述夹持组件还包括垫块,所述垫块固定收容于所述远端夹头内,所述垫块固定套设在所述夹头推管的远端。The valve suture device according to claim 1, wherein the clamping assembly further comprises a cushion block, the cushion block is fixedly received in the distal chuck, and the cushion block is fixedly sleeved in the distal end chuck. The chuck pushes the distal end of the tube.
  15. 如权利要求14所述的瓣膜缝线器,其特征在于,所述垫块包括显影材料。The valve suture device of claim 14, wherein the spacer includes a developing material.
  16. 如权利要求14所述的瓣膜缝线器,其特征在于,所述夹持组件还包括活动穿设于所述近端夹头内的导杆,所述导杆的远端固定于所述垫块上,所述导杆与所述夹头推管间隔设置。The valve suture device of claim 14, wherein the clamping assembly further comprises a guide rod movably inserted in the proximal chuck, and the distal end of the guide rod is fixed to the pad On the block, the guide rod and the chuck push tube are arranged at intervals.
  17. 如权利要求1所述的瓣膜缝线器,其特征在于,还包括活动穿设于所述近端夹头内的探针,所述探针位于所述夹头推管与所述插针组件之间,所述探针与所述夹头推管间隔设置。The valve suture device of claim 1, further comprising a probe movably inserted in the proximal chuck, and the probe is located between the chuck push tube and the pin assembly In between, the probe and the chuck push tube are spaced apart.
  18. 一种瓣膜修复缝线装置,其特征在于,包括如权利要求1-17任意一项所述的瓣膜缝线器及操作主体,所述操作主体上设置插针控制件、引线控制件及夹头控制件,所述插针控制件与所述插针组件的近端连接以控制所述插针组件沿轴向移动,所述引线控制件与所述引线器的近端连接以控制所述引线器沿轴向移动,所述夹头控制件与所述夹头推管的近端连接以控制所述夹头推管沿轴向移动。A suture device for valve repair, which is characterized by comprising the valve suture device and an operating body according to any one of claims 1-17, and the operating body is provided with a needle control member, a lead control member and a chuck A control member, the pin control member is connected with the proximal end of the pin assembly to control the axial movement of the pin assembly, and the lead control member is connected with the proximal end of the lead guide to control the lead The chuck is moved along the axial direction, and the chuck control member is connected with the proximal end of the chuck push tube to control the chuck push tube to move in the axial direction.
  19. 如权利要求18所述的瓣膜修复缝线装置,其特征在于,还包括鞘管,所述鞘管固定连接于所述操作主体与所述近端夹头之间,所述夹头推管、所述引线器及所述插针组件活动穿设于所述鞘管内。The valve repair suture device according to claim 18, further comprising a sheath, the sheath is fixedly connected between the operating body and the proximal chuck, the chuck push tube, The thread guide and the pin assembly are movably installed in the sheath.
  20. 如权利要求18所述的瓣膜修复缝线装置,其特征在于,还包括与所述操作主体固定连接的基座,用于承载所述操作主体。The valve repair suture device according to claim 18, further comprising a base fixedly connected to the operating body for supporting the operating body.
PCT/CN2020/109627 2019-12-06 2020-08-17 Valve suture device and valve repair suture device WO2021109616A1 (en)

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CN201922178565.XU CN211834543U (en) 2019-12-06 2019-12-06 Valve suture device and valve repair suture device
CN201922178565.X 2019-12-06
CN201911245049.2A CN112914635A (en) 2019-12-06 2019-12-06 Valve suture device and valve repair suture device
CN201911245049.2 2019-12-06

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