WO2021135907A1 - Dispositif et système de suture de valve guidé - Google Patents

Dispositif et système de suture de valve guidé Download PDF

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Publication number
WO2021135907A1
WO2021135907A1 PCT/CN2020/136122 CN2020136122W WO2021135907A1 WO 2021135907 A1 WO2021135907 A1 WO 2021135907A1 CN 2020136122 W CN2020136122 W CN 2020136122W WO 2021135907 A1 WO2021135907 A1 WO 2021135907A1
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WO
WIPO (PCT)
Prior art keywords
chuck
proximal
suture
distal
push rod
Prior art date
Application number
PCT/CN2020/136122
Other languages
English (en)
Chinese (zh)
Inventor
李阳
张庭超
甘义杰
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
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 WO2021135907A1 publication Critical patent/WO2021135907A1/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
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • 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
    • 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
    • A61B17/0482—Needle or suture guides
    • 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
    • A61B17/0491—Sewing machines for surgery
    • 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
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/062—Needle manipulators
    • 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
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/062—Needle manipulators
    • A61B17/0625—Needle manipulators the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty

Definitions

  • This application relates to the technical field of medical devices, and in particular to a steerable valve suture device and a valve suture system.
  • Heart valve disease is due to structural damage, fibrosis, adhesions, shortening, myxomatous degeneration, degenerative changes or congenital development caused by inflammation of the heart valves (including valves, chordae (CT as shown in Figure 1) and papillary muscles) Abnormal function or structure of a single valve or multiple valves caused by deformity, trauma, etc., resulting in valve stenosis and insufficiency.
  • 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. Mitral valve regurgitation or tricuspid valve regurgitation can cause ventricular blood to flow back to the atrium during systole, causing the atrial volume to expand and the pressure to increase, leading to increased ventricular load and easy heart failure.
  • Interventional treatment methods mainly include chordal repair or edge-to-edge repair by implanting sutures into the heart valve.
  • an existing interventional heart valve repair instrument 100a for thoracic approach is punctured between the ribs and then the apex of the heart is punctured, and the entire instrument is advanced to the left ventricle and left atrium to implement the mitral valve Valve repair.
  • the valve repair instrument 100a controls and fixes the chuck push rod 330a connected to the distal chuck 310a, so that the distal chuck 310a and the proximal chuck 320a move relative to each other to clamp the valve, and push the puncture needle (not shown) to puncture the valve.
  • the puncture needle is withdrawn to drive the suture through the valve, and then the suture is implanted on the valve, and the implanted suture can be used for subsequent implementation Cord repair or edge-to-edge repair to repair the valve.
  • the operator may cause the chuck push rod to rotate due to improper operation or uncontrollable factors, causing the distal chuck 310a and the proximal chuck 320a to be misaligned and not aligned, which affects the clamping effect of the valve. .
  • the above-mentioned interventional heart valve repair instrument 100a has to be pierced through the apex through the thoracic cavity, so it will still cause some damage to the human body. If a more minimally invasive transvenous heart valve repair operation is used, it will be necessary If the instrument passes through a curved blood vessel, the chuck push rod also needs to have a certain degree of flexibility to bend with the bending of the sheath.
  • the chuck push rod is easy to rotate, and the distal chuck and the chuck are driven by the chuck push rod.
  • the relative movement between the proximal chucks may no longer move in a straight line. In this way, the relative positions of the distal chuck and the proximal chuck are prone to offset, causing the sutures in the distal chuck to interact with the puncture needle. Dislocation, so that the puncture needle cannot be connected to the suture, and the suture cannot be successfully implanted into the valve.
  • the present application provides a steerable valve suture device and valve suture system.
  • the present application discloses a steerable valve suture device for implanting sutures into the valve, including a clamping device and a puncture needle.
  • the clamping device includes a distal chuck, a proximal chuck, A chuck push rod and a guide rod, the chuck push rod is fixedly connected to the guide rod and both movably pass through the proximal chuck, at least one of the chuck push rod and the guide rod Fixedly connected with the distal chuck, the distal chuck is used for accommodating the suture, and the puncture needle is movably pierced through the proximal chuck for puncturing the valve and connecting the suture .
  • the present application also provides a valve suture system, including the above-mentioned steerable valve suture device and an adjustable bend sheath, the adjustable bend sheath includes a sheath and is fixedly connected to the proximal end of the sheath The adjustable bending handle, the chuck push rod and the puncture needle are movably threaded into the adjustable bending sheath.
  • a guide rod fixedly connected to the chuck push rod is provided in the clamping device, and the guiding effect of the guide rod can prevent the chuck from pushing the rod Rotate and ensure that the chuck push rod drives the distal chuck and the proximal chuck to move linearly during the relative opening and closing process, so that the relative position of the distal chuck and the proximal chuck does not shift, and the distal chuck It can always be aligned with the outer peripheral edge of the proximal chuck to effectively clamp the valve, and the suture in the distal chuck and the puncture needle are not misaligned, to ensure that the puncture needle and the suture can be connected smoothly, and the suture direction is realized. Implantation of the valve.
  • Figure 1 is a schematic diagram of the heart structure.
  • Fig. 2 is a schematic diagram showing the structure of an interventional heart valve repair instrument provided by the prior art before the valve is clamped.
  • Fig. 3 is a schematic diagram of the structure of the interventional heart valve repair instrument provided by the prior art when the valve is clamped.
  • FIG. 4 is a schematic diagram of a three-dimensional assembly of the valve suture system provided by the first embodiment of the application.
  • Fig. 5 is a three-dimensional assembly schematic diagram of the steerable valve suture device in Fig. 4.
  • Fig. 6 is a partial enlarged schematic view of the region I of the steerable valve suture device shown in Fig. 5.
  • Fig. 7 is a three-dimensional schematic diagram of the holding device of the steerable valve suture device shown in Fig. 5 in an open state.
  • FIG. 8 is a three-dimensional schematic diagram of the structure of the holding device of the steerable valve suture device shown in FIG. 7 with a part removed.
  • Fig. 9 is an axial cross-sectional view of Fig. 7.
  • Fig. 10 is a partial structural diagram of the steerable valve suture device shown in Fig. 5.
  • Fig. 11 is a three-dimensional schematic diagram of the holding device of the steerable valve suture device shown in Fig. 5 in a closed state.
  • Fig. 12 is a partial structural diagram of the steerable valve suture device shown in Fig. 5.
  • Fig. 13 is a cross-sectional view along A-A in Fig. 12.
  • Fig. 14 is a sectional view taken along B-B in Fig. 12;
  • Fig. 15 is a schematic structural diagram of the puncture device of the steerable valve suture device shown in Fig. 5.
  • Fig. 16 is a partial structural diagram of the puncture needle of the steerable valve suture device shown in Fig. 5.
  • Fig. 17 is a three-dimensional schematic diagram of the suture and puncture needle of the steerable valve suture device shown in Fig. 5.
  • Fig. 18 is a three-dimensional schematic diagram of the assembly of the fixing member and suture of the steerable valve suture device shown in Fig. 5 together.
  • FIG. 19 is a schematic diagram of an application scenario of a valve suture system provided by an embodiment of the application.
  • Fig. 20 is a partial schematic diagram of the application scenario shown in Fig. 19.
  • FIG. 21 is a partial schematic diagram of another application scenario of the valve suture system provided by an embodiment of the application.
  • Fig. 22 is a partial structural diagram of the valve suture system provided by the second embodiment of the application.
  • Fig. 23 is a partial structural diagram of the valve suture system provided by the third embodiment of the application.
  • FIG. 24 is a cross-sectional view of the chuck push rod and the stopper of the valve suture system provided by the third embodiment of the application.
  • the position close to the operator is usually defined as the proximal end, and the position 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 direction of the central axis of rotation.
  • the common direction is defined as the axial direction.
  • FIG. 4 is a three-dimensional assembly diagram of the valve suture system provided by the first embodiment of the application
  • FIG. 5 is a three-dimensional assembly diagram of the steerable valve suture device in FIG. 4
  • Figure 6 is a partial enlarged schematic view of the region of the steerable valve suture device I shown in Figure 5.
  • the present application provides a valve suture system 200 for implanting a suture 400 (as shown in FIG. 16) into a heart valve to perform edge-to-edge repair on the heart valve.
  • the valve suture system 200 includes an adjustable bending sheath 300 and a steerable valve suture device 100 partially penetrated in the adjustable bending sheath 300.
  • the steerable valve suture device 100 includes an operating handle 10, a catheter 30, a holding device 50 and a puncture device 70.
  • the catheter 30 is connected between the clamping device 50 and the operating handle 10, and is used to deliver the clamping device 50 into the heart.
  • the puncture device 70 is movably installed in the clamping device 50, the catheter 30 and the operating handle 10.
  • the clamping device 50 is used for accommodating the suture 400 and clamping the valve.
  • the puncture needle 71 in the puncture device 70 is used to puncture the valve and is fixedly connected with the suture 400, and then pulls the suture 400 out of the valve to realize the implantation of the suture 400.
  • the operating handle 10 is used to facilitate the operator to hold and manipulate the clamping device 50 and the puncture device 70.
  • the adjustable bending sheath 300 includes a sheath 310 and a bending handle 320.
  • the proximal end of the sheath 310 is fixedly connected with the bending handle 320.
  • the catheter 30 is movably installed in the sheath 310 and the bending handle 320.
  • the bending handle 320 is used to control the bending of the sheath 310, and the catheter 30 inserted in the sheath 310 can be bent in response to the bending of the sheath 310.
  • the operating handle 10 is provided with a chuck control member 11 for controlling the opening and closing of the clamping device 50.
  • the length of the catheter 30 is not limited.
  • FIG. 7 is a three-dimensional schematic diagram of the holding device of the steerable valve suture device shown in FIG. 5 in an opened state.
  • the clamping device 50 includes a proximal chuck 51, a distal chuck 53 and a chuck push rod 55.
  • the proximal clamp 51 is fixedly connected to the catheter 30.
  • the chuck push rod 55 movably passes through the proximal chuck 51 and is fixedly connected with the distal chuck 53, and the chuck push rod 55 is also movably passed through the catheter 30.
  • the proximal chuck 51 is located between the distal chuck 53 and the catheter 30.
  • the proximal chuck 51 has a proximal clamping surface 517 on the side close to the distal chuck 53
  • the distal chuck 53 has a distal clamping surface 537 on the side close to the proximal chuck 51, and the proximal clamping surface 517. It is arranged opposite to the distal end clamping surface 537, and is used to effectively clamp the valve when clamping the valve.
  • the effective clamping is for the clamping device 50 to stably clamp the valve, so that the valve is not easy to fall off from the clamping device 50.
  • the proximal clamping surface 517 and the distal clamping surface 537 are both inclined surfaces.
  • proximal clamping surface 517 and the distal clamping surface 537 are not limited to be inclined surfaces inclined with respect to the axis of the clamping device 50.
  • both the proximal clamping surface 517 and the distal clamping surface 537 may be, but are not limited to, A plane perpendicular to the axis of the clamping device 50, etc.
  • FIG. 8 is a three-dimensional schematic diagram of the valve suture system shown in FIG. 4 with part of the structure removed.
  • the distal chuck 53 is driven by the chuck push rod 55 to move away from the proximal chuck 51, and the distal chuck 53 and the proximal chuck 51 are relatively open, so that the clamping device 50 is in an open state.
  • the material of the chuck push rod 55 is polyetheretherketone (PEEK for short). It is understandable that the material of the chuck push rod 55 is not limited, as long as the chuck push rod 55 has good mechanical strength and a certain flexible bending ability.
  • the chuck push rod 55 can be, but not limited to, a spring tube or a cutting recess. Grooved stainless steel rod.
  • the outer diameter of the proximal chuck 51 is larger than the outer diameter of the catheter 30.
  • the proximal chuck 51 includes a proximal chuck base 511 and a proximal chuck main body 513 that are fixedly connected, and the proximal chuck base 511 is fixedly connected between the proximal chuck main body 513 and the catheter 30.
  • the proximal collet holder 511 has a diameter reducing section, and the radial dimension of the diameter reducing section gradually increases from the proximal end to the distal end, so that the radial dimension of the proximal collet holder 511 gradually increases from the diameter close to the catheter 30 It is as large as the diameter of the main body 513 of the proximal chuck.
  • the setting of the proximal chuck seat 511 is used to adapt to the change in the outer diameter from the catheter 30 to the proximal chuck body 513.
  • the steerable valve suture device 100 smoothly travels or exits in the vena cava vessel.
  • valve suture device 100 that can be guided by the valve can pass smoothly during puncturing or exiting the atrial septum, so as to prevent the clamping device 50 from scraping the inner wall of the blood vessel.
  • it avoids the proximal chuck body 513 and the catheter 30. The formation of steps between them increases the possibility of thrombosis.
  • the proximal chuck main body 513 is provided with a channel (not shown) for the puncture needle 71 to move through.
  • the chuck push rod 55 includes a fixedly connected straight section 551 and a connecting section 553.
  • the straight section 551 is fixedly connected to the distal chuck 53 and movably passes through the proximal chuck body 513, and the connecting section 553 movably passes through the proximal chuck.
  • the head base 511 (as shown in FIG. 7) and the connecting section 553 extend from the connection with the straight section 551 toward the duct 30 (as shown in FIG. 6) and are gathered in the duct 30.
  • the connecting section 553 is bent toward the axial direction of the duct 30.
  • the setting of the connecting section 553 adapts to the radial size change of the diameter reducing section of the proximal collet holder 511 from the proximal end to the distal end and transmits the thrust or the pulling force to the straight section 551.
  • FIG. 9 is an axial cross-sectional view of FIG. 7, and FIG. 10 is a partial structural diagram of the steerable valve suture device shown in FIG. 5.
  • the clamping device 50 further includes a guide rod 58 and a limiting member 59.
  • the limiting member 59 is movably received in the proximal chuck main body 513.
  • the guide rod 58 and the chuck push rod 55 are fixedly interposed between the stop member 59 and the distal chuck 53 at intervals, and the chuck push rod 55 and the guide rod 58 are both fixed to the distal chuck 53 to realize the guide rod 58 It is fixedly connected with the chuck push rod 55.
  • the guide rod 58 is used to provide a guiding effect when the chuck push rod 55 drives the distal chuck 53 to move relative to the proximal chuck 51. Since the guide rod 58 and the chuck push rod 55 are fixedly connected, the chuck push rod 55 can be effectively restricted from rotating in a limited space, and the alignment accuracy of the distal chuck 53 and the proximal chuck 51 is improved.
  • the guide rod 58 is not restricted to the fixed connection of the distal chuck 53.
  • the guide rod 58 can be fixedly connected to the proximal chuck body 513 and movably penetrates the distal chuck 53 to ensure that the guide rod 58 will not escape from The distal chuck 53 only needs to be pulled out, so that the guide rod 58 provides a guiding function for the movement of the distal chuck 53.
  • a through hole 5131 is provided on the proximal chuck body 513, and the through hole 5131 is provided along the axial direction of the proximal chuck body 513, and the guide rod 58 is movably mounted on the proximal chuck.
  • the guide rod 58 is restricted from axial linear movement.
  • the number of the guide rods 58 is two, the two guide rods 58 are respectively located on both sides of the chuck push rod 55, and the two guide rods 58 and the chuck push rod 55 are substantially located on the same plane. It can be understood that the number of guide rods 58 is not limited.
  • the number of guide rods 58 may be 1, 3, and so on. It can be understood that when the number of the guide rods 58 is greater than one, the guide rods 58 are not limited to be located on both sides of the chuck push rod 55, and the guide rods 58 may but are not limited to be located on the same side of the chuck push rod 55. It can be understood that the guide rod 58 is not restricted to move through the proximal chuck main body 513, and the guide rod 58 can provide guidance for the movement of the distal chuck 53.
  • the guide rod 58 may be, but is not limited to, a telescopic rod and fixedly connected between the distal chuck 53 and the proximal chuck body 513.
  • the guide rod 58 is a rigid cylindrical rod body. It can be understood that the guide rod 58 is not limited to be cylindrical.
  • the guide rod 58 may be, but is not limited to, a rectangular parallelepiped or a rod whose diameter gradually decreases/increases along the proximal chuck body 513 toward the distal chuck 53.
  • the far/proximal end surfaces of the two guide rods 58 are flush. It can be understood that the far/proximal end faces of the two guide rods 58 are not restricted to be flush.
  • the proximal chuck body 511 has a limiting surface 5113 on a side facing away from the distal chuck 53.
  • the guide rod 58 also moves toward the distal chuck 53.
  • the limit member 59 can be blocked by the limit surface 5113 to prevent the guide rod 58 from escaping from the proximal chuck body 513.
  • two guide rods 58 are fixedly connected to one limiting member 59.
  • the number of the limiting member 59 may be two, so that the two guide rods 58 are fixedly connected to one limiting member 59 respectively.
  • the limiting member 59 is not limited to be installed in the proximal chuck main body 513, for example, the limiting member 59 may also be installed in the proximal chuck base 511. It can be understood that the shape and size of the limiting member 59 are not limited, as long as the limiting member 59 cannot pass through the through hole 5131.
  • the limiting member 59 is not limited to be fixedly sleeved outside the chuck push rod 55, for example, the limiting member 59 may be but not limited to be sleeved outside the chuck push rod 55 and not fixedly connected to the chuck push rod 55 .
  • the clamping device 50 further includes a spacer 56 fixedly installed at the distal end of the distal chuck 53, the spacer 56 is fixedly sleeved on the chuck push rod 55, and the spacer 56 is also fixedly sleeved on the guide rod 58.
  • the spacer 56 can be omitted.
  • the chuck push rod 55 and the guide rod 58 may be directly and fixedly connected to the distal chuck 53 respectively, but are not limited to.
  • the chuck push rod 55 When the chuck push rod 55 moves, it can drive the distal chuck 53 and the guide rod 58 to move. Because the clamping device 50 is provided with a guide rod 58 fixedly connected to the chuck push rod 55, the guiding effect of the guide rod 58 can prevent The chuck push rod 55 rotates and ensures that the chuck push rod 55 drives the distal chuck 53 and the proximal chuck 51 to move linearly during the relative opening and closing process, so that the distal chuck 53 and the proximal chuck 51 are relative to each other. The position does not shift, and the outer peripheral edges of the distal chuck 53 and the proximal chuck 51 can always be aligned to effectively clamp the valve. In addition, the suture 400 in the distal chuck 53 and the puncture needle 71 are not misaligned, so that the puncture needle 71 and the suture 400 can be connected smoothly, and the suture 400 is implanted into the valve.
  • the spacer 56, the limiting member 59 and the two guide rods 58 are enclosed in a rectangular frame structure, which is stable in structure.
  • the chuck push rod 55 movably passes through the limiting member 59 and is fixedly connected with the cushion block 56, and the chuck push rod 55 is located between the two guide rods 58. It can be understood that, in some other embodiments, at least one of the chuck push rod 55 and the guide rod 58 may be fixedly connected to the spacer 56.
  • the stopper 59 drives the guide rod 58 to move under the drive of the chuck push rod 55 to indirectly drive the distal chuck 53 to move relative to the proximal chuck body 513, that is, to push the chuck to push
  • the rod 55 can also achieve the purpose of driving the distal chuck 53 to move in a straight line relative to the proximal chuck body 513.
  • the chuck push rod 55 is provided with a channel 554, the distal chuck 53 is provided with a channel 534 communicating with the channel 554, and the channel 554 and the channel 534 are used for accommodating the suture 400.
  • the channel 534 includes a first channel portion 5341 and a second channel portion 5342 that are in communication with each other.
  • the first channel portion 5341 is connected between the channel 554 and the second channel portion 5342, and the first channel portion 5341 is disposed at the distal end of the distal chuck 53
  • the second channel portion 5342 is disposed on the side of the distal chuck 53 away from the channel 554.
  • the first channel portion 5341 extends along the inner side of the top wall of the distal end of the distal chuck 53, and the first channel portion 5341 and the second channel portion 5342 are smoothly connected. In this way, the suture 400 can be drawn smoothly by the puncture needle 71, and the suture 400 can be easily drawn from the channel 534 and the channel 554.
  • the extending path of the channel 534 is not limited, so that the suture 400 accommodated in the channel 534 can be easily pulled out.
  • FIG. 11 is a three-dimensional schematic diagram of the holding device of the steerable valve suture device shown in FIG. 5 in a closed state.
  • the clamping device 50 further includes a transmission mechanism 57, which is fixedly connected to the end of the chuck push rod 55 away from the distal chuck 53.
  • the transmission mechanism 57 is installed inside the operating handle 10 (as shown in FIG. 5).
  • the transmission mechanism 57 is controlled and driven by the chuck control member 11 (as shown in FIG. 5 ).
  • the chuck control member 11 When the chuck control member 11 is rotated, the movement of the chuck control member 11 is converted into the axial movement of the transmission mechanism 57 and the chuck push rod 55.
  • the distal chuck 53 is driven by the chuck push rod 55 to be relatively close to the proximal chuck body 513 so that the distal chuck 53 and the proximal chuck body 513 are in a closed state; as shown in FIG. 7, the distal chuck 53 is
  • the chuck push rod 55 can be driven to be relatively far away from the proximal chuck body 513, so that the distal chuck 53 and the proximal chuck body 513 are in an open state, so that the distal chuck 53 and the proximal chuck body 513 are clamped together. Or loosen the valve.
  • Figure 12 is a partial structural diagram of the steerable valve suture device shown in Figure 5
  • Figure 13 is a cross-sectional view along AA in Figure 12
  • Figure 14 is in Figure 12 Section along BB.
  • the chuck push rod 55 is located close to the outer peripheral edges of the distal chuck 53 and the proximal chuck body 513. Accordingly, the guide rod 58 is also close to the distal chuck 53 and the proximal chuck body 513. The outer peripheral edge is arranged close to the chuck push rod 55 and is located on both sides of the chuck push rod 55.
  • the clamping device 50 When the chuck push rod 55 pushes the distal chuck 53 away from the proximal chuck body 513, the clamping device 50 is in an open state, and the opposite end of the distal chuck 53 and the proximal chuck body 513 (that is, the distal chuck The holding surface 537 and the proximal clamping surface 517) and the chuck push rod 55 form an open area, and the area inside the opening (that is, the side of the guide rod 55 that faces away from the edge of the proximal chuck body 513) is used to accommodate and capture valve.
  • the chuck push rod 55 and the guide rod 58 are arranged close to the edges of the distal chuck 53 and the proximal chuck body 513, so that the smaller the area occupied by the guide rod 58 and the chuck push rod 55, the distal clamping surface 537 and The larger the contact area between the proximal clamping surface 517 and the valve, that is, the greater the effective area of the clamping device 50 that can clamp the valve, which is beneficial to enhance the stability of the clamping valve, and is beneficial to increase the success rate of the operation, and to increase The force-receiving area of a large valve can reduce damage to the valve.
  • the proximal chuck body 513 is provided with a channel 5132 for the puncture needle 71 to penetrate.
  • the channel 5132 is in communication with the channel 534 in the distal chuck 53.
  • the guide rod 58 since the guide rod 58 is included, the relative position of the distal chuck 53 and the proximal chuck body 513 does not shift, so that the channel 5132 and the second channel portion 5342 are always aligned to ensure puncture
  • the needle 71 (as shown in FIG. 9) can enter the second channel portion 5342 after puncturing the valve and be fixedly connected with the suture 400 (as shown in FIG. 9).
  • FIG. 15 is a schematic structural diagram of the puncture device 70 of the steerable valve suture device shown in FIG. 5.
  • the puncture device 70 includes a puncture needle 71, a puncture push rod 73 and a push handle 75.
  • the puncture push rod 73 is fixedly connected between the puncture needle 71 and the push handle 75.
  • the push handle 75 is movably installed in the operating handle 10 (as shown in FIG. 5) and penetrates from the end of the operating handle 10 away from the catheter 30 (as shown in FIG. 5) to drive the puncture needle 71 to advance or withdraw.
  • the puncture push rod 73 is movably installed in the catheter 30, and the puncture needle 71 is partially movably installed in the proximal chuck base 511 (as shown in FIG. 7) and the proximal chuck body 513 (as shown in FIG. 7).
  • the suture 400 is fixedly connected to the suture 400 accommodated in the distal chuck 53 and the suture 400 is pulled out.
  • the manner in which the puncture push rod 73 and the puncture handle 75 are fixedly connected is not limited, for example, a snap connection, an undercut connection, a threaded connection, etc., can be used but not limited to.
  • FIG. 16 is a partial structural diagram of the puncture needle of the steerable valve suture device shown in FIG. 5.
  • the puncture needle 71 includes a needle head 711, a distal connecting member 713 and a flexible needle body 714, and the distal connecting member 713 is fixedly connected between the needle head 711 and the flexible needle body 714.
  • the needle head 711 is used to puncture the valve and is fixedly connected with the suture 400.
  • the bendable needle body 714 is movably inserted in the catheter 30. The bendable needle body 714 can be bent under the influence of the bending of the catheter 30 so as to adapt to the tortuous puncture path during catheter interventional treatment.
  • the bendable needle body 714 includes a bendable needle tube 7143 and a support inner core 7145, and the support inner core 7145 is inserted into the bendable needle tube 7143.
  • the supporting core 7145 is fixedly connected to the distal connecting member 713.
  • the flexible needle tube 7143 can be bent to adapt to a tortuous puncture path.
  • the supporting core 7145 is a nickel-titanium wire. It can be understood that the support inner core 7145 may not be limited to nickel-titanium wire, and it may be made of other materials with a shape memory function. It can be understood that the supporting core 7145 may also be made of other materials, such as non-metallic materials.
  • the support inner core 7145 can bend with the bendable needle tube 7143 and provide support for the bendable needle tube 7143, reducing the loss of the pushing force of the puncture push rod 73 to the bendable needle body 714, and before the chuck push rod 55 drives the puncture handle 75
  • the axial force can be transmitted when pushing and withdrawing, especially when the puncture needle 71 is retracted, the bendable needle body 714 is protected from being stretched and deformed.
  • the bendable needle tube 7143 is a spring tube. It can be understood that the bendable needle tube 7143 is not limited to a spring tube, and the bendable needle tube 7143 can be bent.
  • the needle head 711 includes a needle tip 7112 and a protrusion 7113 that are fixedly connected.
  • the protruding portion 7113 is used to be fixedly connected with the distal connecting member 713.
  • the distal connector 713 has a through hole 717, and the protrusion 7113 penetrates through one end of the through hole 717 and is fixedly connected to the distal connector 713.
  • the length of the support inner core 7145 is greater than the length of the bendable needle tube 7143, and the part of the support inner core 7145 adjacent to the needle head 711 that exposes the bendable needle tube 7143 is fixed through the distal connector 713.
  • the distal connecting member 713 is not limited to have a through hole 717.
  • the distal connecting member 713 may, but is not limited to, providing a blind hole at each end of the distal connecting member 713, so that the protrusion 7113 and the supporting core 7145 are fixedly penetrated into the blind holes from both ends of the distal connecting member 713.
  • the end of the needle head 711 away from the supporting inner core 7145 is straight, which facilitates the transmission of reliable puncture force to the needle head 711 to make it easier to puncture the valve and make the needle head 711 more stable.
  • the protrusion 7113 is a cylindrical section. It can be understood that the shape of the protrusion 7113 is not limited, and the shape of the protrusion 7113 satisfies the shape of the protrusion 7113 to pass through the distal connecting member 713 and be fixedly connected to it.
  • the distal connector 713 is linear and rigid to provide reliable puncture force and maintain stability when puncturing the valve.
  • the fixing method adopted is to support the inner core 7145 and the distal connector 713 to be crimped. It can be understood that the crimping of the supporting core 7145 and the distal connector 713 is not limited, for example, threaded connection, glued connection, etc. can be used but not limited to.
  • the puncture needle 71 further includes a proximal connecting member 716, and the supporting core 7145 is fixedly pierced through the proximal connecting member 716, and the proximal connecting member 716 is used for fixedly connecting the puncture push rod 73 and the bendable needle body 714.
  • the support core 7145 is crimped with the proximal connector 716. It can be understood that the crimping of the support core 7145 and the proximal connector 716 is not limited, for example, a threaded connection may be adopted but not limited to.
  • the distal connecting member 713 and the proximal connecting member 716 respectively press the bendable needle tube 7143 at both ends of the bendable needle tube 7143 to be restricted and fixed.
  • connection between the needle head 711 and the distal connector 713 is approximately the same as the outer diameter of the distal connector 713 and is smoothly connected.
  • the bendable needle tube 7143, the distal connector 713, and the proximal connector 716 The outer diameters are roughly the same and they are smoothly connected, which reduces the resistance of the puncture needle 71 during puncture.
  • the material of the distal connecting member 713 can be, but not limited to, 304 stainless steel, 316 stainless steel, or the like.
  • the end of the needle tip 7112 away from the distal connecting member 713 is a tapered tip, which can reduce the puncture point and reduce the damage to the valve compared with the existing hook needle head 711.
  • the tip of the needle tip 7112 is sharp and wear-resistant, and can be, but not limited to, martensitic stainless steel (ie, 420 stainless steel), heat-treated or low-temperature nitriding 304 stainless steel and 316 stainless steel.
  • the needle head 711 is also provided with a step 7115 for being fixedly connected with the suture 400 by snapping.
  • Figure 17 is a three-dimensional schematic diagram of the suture and puncture needle of the steerable valve suture device shown in Figure 5
  • Figure 18 is a perspective view of the steerable valve suture device shown in Figure 5
  • the steerable valve suture device 100 further includes a fixing member 430.
  • the fixing member 430 is fixedly connected with the suture 400.
  • the fixing member 430 is used for making the suture 400 and the puncture needle 71 easy to snap and connect, so that the suture body 410 can be pulled out by the puncture needle 71.
  • the suture body 410 extends along the channel 534 in the distal chuck 53 and the channel 554 of the chuck push rod 55.
  • the fixing member 430 is accommodated in the second channel part 5342 of the distal chuck 53.
  • the fixing member 430 is a hollow tube structure. It can be understood that the fixing member 430 is not limited to a hollow tube structure.
  • the fixing member 430 is provided with a buckle close to the inside of the tube of the puncture needle 71 for engaging with the step 7115 of the needle head 711 (as shown in FIG. 16 ). It can be understood that the fixing member 430 and the needle head 711 are not restricted to be engaged with each other.
  • the state diagram of the fixing member 430 and the needle head 711 in snapping connection is shown in FIG. 18.
  • the snap connection between the fixing member 430 and the needle head 711 is non-detachable or detachable.
  • connection manner of the needle head 711 and the fixing member 430 is not limited, for example, but not limited to a glue connection or the like.
  • the steerable valve suture device 100 provided in the present application is used to implant a suture 400 into the tricuspid valve, and the femoral vein (CFV as shown in FIG. 19) is opened first.
  • the clamping device 50 is sequentially delivered to the right atrium (RA as shown in FIG. 19) and right ventricle (RV as shown in FIG. 19) via the inferior vena cava (IVC as shown in FIG. 19) and reaches the position of the valve.
  • RA right atrium
  • RV right ventricle
  • IVC inferior vena cava
  • the chuck push rod 55 is driven to retract toward the proximal end, and the distal chuck 53 is driven by the chuck push rod 55 to approach the proximal chuck body 513, and the distal chuck 53 and the proximal chuck body 513 are relatively closed. And capture the valve.
  • the puncture needle 71 (shown in FIG. 15) is pushed by the puncture push rod 73 (shown in FIG. 15) to puncture the valve toward the distal chuck 53, and is fixedly connected with the fixing member 430 (shown in FIG. 17). After that, the puncture needle 71 is driven by the puncture push rod 73 to withdraw in the direction of the operating handle 10, and the suture body 410 is pulled out from the distal chuck 53 under the drive of the puncture needle 71 and passes through the valve, so that the suture 400 is implanted in the valve.
  • the steerable valve suture device 100 provided in the present application is used to implant sutures into the mitral valve, and the femoral vein (CFV as shown in FIG. 19) is opened first.
  • the clamping device 50 is delivered to the right atrium (RA as shown in Figure 21) through the inferior vena cava, and then the interatrial septum is punctured (FO as shown in Figure 21), and then delivered into the left atrium (LA as shown in Figure 21) and The left ventricle (LV as shown in Figure 21) finally reaches the position of the mitral valve.
  • the way of the steerable valve suture device 100 implanting the suture 400 on the mitral valve is similar to the way of implanting the suture 400 on the tricuspid valve, and will not be repeated here.
  • FIG. 22 is a partial structural diagram of the valve suture system provided by the second embodiment of this application.
  • the valve suture system provided by the second embodiment of the present application is roughly similar in structure to the valve suture system provided by the first embodiment, except that the guide rod 523 is fixedly connected between the stopper 524 and the cushion block 529; the chuck pushes The rod 526 is fixed to the limiting member 524 and extends in a direction away from the pad 529.
  • the chuck push rod 526 is a solid rod to increase the strength of the chuck push rod 526.
  • the shape of the guide rod 523 is a cylinder and the number is two.
  • the guide rods 523 are arranged at intervals. It can be understood that the shape of the guide rod 523 is not limited to a cylinder and the number is two.
  • the shape of the guide rod 523 may be but not limited to a cylinder and the number is three, or the shape of the guide rod 523 may be but not limited to a cuboid and the number is one. That is, the setting of the guide rod 523 satisfies the limitation of the distal chuck, so as to avoid the relative position of the distal chuck and the proximal chuck from shifting.
  • the chuck push rod 526 can drive the movement of the stopper 524 and indirectly drive the movement of the guide rod 523.
  • the distal chuck can move away from or close to the proximal chuck (not shown) under the drive of the guide rod 523 to realize the distal chuck (figure not shown) Not shown) and the relative opening and closing of the proximal chuck.
  • the clamping device further includes a suture tube 527, which is fixedly connected to the limiting member 524 and extends toward a side away from the cushion block 529.
  • the suture tube 527 and the chuck push rod 526 are spaced apart, and the suture tube 527 is used to accommodate the suture 600 and provide a guiding function for the suture 600.
  • the chuck push rod 526 is a solid rod, and an independent suture tube 527 is provided next to the chuck push rod 526 for accommodating the suture 600, and the chuck push rod 526 is separated from the suture tube 527.
  • the chuck push rod 526 is fixed to the limiting member 524 and extends in a direction away from the cushion block 529.
  • the suture 600 extends along the suture tube 527 toward the distal collet. In this way, under the premise of providing the same axial support force, the outer diameter of the chuck push rod 526 can be relatively reduced, which is beneficial to provide a larger effective clamping area and enhance the stability of the clamping valve.
  • FIG. 23 is a partial structural diagram of the valve suture system provided by the third embodiment of this application.
  • 24 is a cross-sectional view of the chuck push rod and the stopper of the valve suture system provided by the third embodiment of the application.
  • the valve suture system provided by the third embodiment of the present application is roughly similar in structure to the valve suture system provided by the first embodiment. The difference is that the puncture needle 770 is provided with a groove 771 for holding the suture 800 and is used for puncturing. The needle 770 prevents the suture 800 from separating from the puncture needle 770 when the suture 800 is pulled back.
  • the chuck push rod 764 is provided with a through hole 7641 at one end adjacent to the spacer 767, and the suture 800 can pass through the through hole 7641 to form a substantially ring-shaped coil portion 810.
  • the suture 800 provided in this embodiment further includes a connecting portion 820 fixedly connected to the coil portion 810.
  • the connecting portion 820 is movably inserted in the chuck push rod 764, and the coil portion 810 passes through the through hole 7641 and is accommodated in the remote End chuck (not shown).
  • the coil part 810 passes through the through hole 7641 and enters the distal chuck, and the coil formed by the coil part 810 is clamped by the groove 771.
  • the puncture needle 770 punctures the valve toward the distal chuck and passes through the coil 810, and then tightens the connecting portion 820 so that the coil portion 810 enters the groove 771 and is clamped and connected with the puncture needle 770.
  • the puncture needle 770 is withdrawn, and the suture 800 is pulled from the distal chuck under the drive of the puncture needle 770 and passed through the valve, so that the suture 800 is implanted on the valve.
  • the fixing member is omitted, and the puncture needle 770 is directly clamped and connected with the suture 800, which simplifies the structure on the one hand; on the other hand, it avoids the damage to the human valve when the fixing member passes through the valve.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
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Abstract

L'invention concerne un dispositif et un système de suture de valve guidé (100), comprenant un dispositif de serrage (50) et une aiguille de ponction (71) ; le dispositif de serrage (50) comprend une tête de serrage à extrémité distale (53), une tête de serrage à extrémité proximale (51), une tige de poussée de tête de serrage (55) et une tige de guidage (58) ; la tige de poussée de tête de serrage (55) et la tige de guidage (58) sont reliées de manière fixe et sont disposées de manière mobile en traversant la tête de serrage à extrémité proximale (51) ; au moins la tige de poussée de tête de serrage (55) et/ou la tige de guidage (58) sont reliées de manière fixe à la tête de serrage d'extrémité distale (53) ; la tête de serrage d'extrémité distale (53) est utilisée pour recevoir une suture (400) ; l'aiguille de ponction (71) est disposée de manière mobile en traversant la tête de serrage d'extrémité proximale (51) et est utilisée pour percer une valve et relier une suture (400). L'agencement de la tige de guidage (58) peut empêcher la tige de poussée de la tête de serrage (55) de tourner et garantir que la tige de poussée de la tête de serrage (55) entraîne la tête de serrage de l'extrémité distale (53) et la tête de serrage de l'extrémité proximale (51) pour qu'elles se déplacent linéairement pendant le processus d'ouverture et de fermeture l'une par rapport à l'autre, de telle sorte que la position relative de la tête de serrage à l'extrémité distale (53) et de la tête de serrage à l'extrémité proximale (51) ne se déplace pas et que le bord périphérique externe puisse toujours être aligné, en maintenant efficacement la valve, et en garantissant que la suture (400) dans la tête de serrage à l'extrémité distale (53) et l'aiguille de ponction (71) ne soient pas désalignées et puissent être reliées sans difficulté, permettant à la suture (400) d'être implantée dans la valve.
PCT/CN2020/136122 2019-12-31 2020-12-14 Dispositif et système de suture de valve guidé WO2021135907A1 (fr)

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CN201911413805.8A CN113116423A (zh) 2019-12-31 2019-12-31 可导向的瓣膜缝线器及瓣膜缝线系统
CN201911413805.8 2019-12-31

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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
CN211934164U (zh) * 2019-12-31 2020-11-17 杭州德晋医疗科技有限公司 可导向的瓣膜缝线器及瓣膜缝线系统

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CN102892359A (zh) * 2010-01-29 2013-01-23 麦德风险投资有限责任公司 用于缝合心脏开口的方法和装置
US20170258464A1 (en) * 2014-01-03 2017-09-14 Harpoon Medical, Inc. Method and apparatus for transapical procedures on a mitral valve
CN104248457A (zh) * 2014-09-03 2014-12-31 郭文彬 一种人工腱索装置、穿引元件及套件
CN104706391A (zh) * 2015-03-26 2015-06-17 诺琅医疗科技（上海）有限公司 一种可以切割缝合线的垫片锁紧导管
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CN117224179A (zh) * 2023-09-05 2023-12-15 南京思脉德医疗科技有限公司 缝合用针脚调节机构及可用于卵圆孔未闭的缝合器
CN117224179B (zh) * 2023-09-05 2024-02-23 南京思脉德医疗科技有限公司 缝合用针脚调节机构及可用于卵圆孔未闭的缝合器

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