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WO2021109616A1 - Dispositif de suture de valve et dispositif de suture de réparation de valve - Google Patents

Dispositif de suture de valve et dispositif de suture de réparation de valve 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
Authority
WO
WIPO (PCT)
Prior art keywords
chuck
valve
distal
proximal
push tube
Prior art date
Application number
PCT/CN2020/109627
Other languages
English (en)
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/zh
Priority claimed from CN201911245049.2A external-priority patent/CN112914635B/zh
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/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente demande divulgue un dispositif de suture de valve (50) ainsi qu'un dispositif de suture de réparation de valve (100), le dispositif de suture de valve (50) comprenant un ensemble de serrage (60), un ensemble aiguille (70) et un guide-fil (80); l'ensemble de serrage (60) comprend un mandrin proximal (61), un tube de poussée de mandrin (65) et un mandrin distal (63), le tube de poussée de mandrin (65) étant inséré de manière mobile dans le mandrin proximal (61) et relié de manière fixe au mandrin distal (63); l'ensemble aiguille (70) est inséré de manière mobile dans le mandrin proximal (61) et relié au tendon artificiel maintenu dans le mandrin proximal; le guide-fil (80) est inséré de manière mobile dans le tube de poussée de mandrin (65) et le mandrin distal (63), l'ensemble aiguille (70) est utilisé pour tirer le tendon artificiel de manière à percer la valve du côté atrium au côté ventriculaire et pénétrer dans le guide-fil (80), le guide-fil est utilisé pour accrocher le tendon artificiel pour le tirer dans le tube de poussée de mandrin et le retirer vers l'extrémité proximale, de telle sorte qu'une partie du tendon artificiel soit confinée sur le côté de la valve à proximité de l'atrium et le reste du tendon artificiel sorte sur le côté du ventricule et puisse s'étendre le long du côté du ventricule.
PCT/CN2020/109627 2019-12-06 2020-08-17 Dispositif de suture de valve et dispositif de suture de réparation de valve WO2021109616A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201922178565.X 2019-12-06
CN201911245049.2 2019-12-06
CN201922178565.XU CN211834543U (zh) 2019-12-06 2019-12-06 瓣膜缝线器及瓣膜修复缝线装置
CN201911245049.2A CN112914635B (zh) 2019-12-06 2019-12-06 瓣膜缝线器及瓣膜修复缝线装置

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CN109044564A (zh) * 2018-07-17 2018-12-21 江苏大学 一种二尖瓣人工腱索放置器械
CN109833117A (zh) * 2017-11-28 2019-06-04 杭州德晋医疗科技有限公司 双侧人工腱索植入系统
CN109893297A (zh) * 2017-12-07 2019-06-18 杭州德晋医疗科技有限公司 带夹持辅助装置的人工腱索植入系统
US20190290260A1 (en) * 2018-03-23 2019-09-26 Neochord, Inc. Device for suture attachment for minimally invasive heart valve repair
CN110313947A (zh) * 2018-03-28 2019-10-11 杭州德晋医疗科技有限公司 心脏瓣膜修复系统
CN209529400U (zh) * 2017-07-31 2019-10-25 杭州德晋医疗科技有限公司 人工腱索及其人工腱索植入系统

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CN101902975A (zh) * 2007-10-18 2010-12-01 尼奥绰德有限公司 搏动心脏中瓣膜小叶的微创修复
US20150282805A1 (en) * 2014-04-08 2015-10-08 Lsi Solutions, Inc. Surgical suturing device for a replacement anatomical structure and methods thereof
CN104665888A (zh) * 2015-02-16 2015-06-03 江苏大学 一种微创植入人工腱索的二尖瓣腱索缝纫机及其方法
US20180280138A1 (en) * 2017-03-31 2018-10-04 Neochord, Inc. Minimally Invasive Heart Valve Repair in a Beating Heart
CN209529400U (zh) * 2017-07-31 2019-10-25 杭州德晋医疗科技有限公司 人工腱索及其人工腱索植入系统
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CN109833117A (zh) * 2017-11-28 2019-06-04 杭州德晋医疗科技有限公司 双侧人工腱索植入系统
CN109893297A (zh) * 2017-12-07 2019-06-18 杭州德晋医疗科技有限公司 带夹持辅助装置的人工腱索植入系统
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CN109044564A (zh) * 2018-07-17 2018-12-21 江苏大学 一种二尖瓣人工腱索放置器械

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