WO2021185323A1 - 前推释放型缝合线锁结装置 - Google Patents

前推释放型缝合线锁结装置 Download PDF

Info

Publication number
WO2021185323A1
WO2021185323A1 PCT/CN2021/081591 CN2021081591W WO2021185323A1 WO 2021185323 A1 WO2021185323 A1 WO 2021185323A1 CN 2021081591 W CN2021081591 W CN 2021081591W WO 2021185323 A1 WO2021185323 A1 WO 2021185323A1
Authority
WO
WIPO (PCT)
Prior art keywords
chuck
push rod
inclined surface
locking device
push
Prior art date
Application number
PCT/CN2021/081591
Other languages
English (en)
French (fr)
Inventor
李阳
梁伟林
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 CN202010205925.5A external-priority patent/CN113491547A/zh
Priority claimed from CN202020370900.6U external-priority patent/CN212490016U/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
Priority to EP21771267.8A priority Critical patent/EP4122403A4/en
Publication of WO2021185323A1 publication Critical patent/WO2021185323A1/zh
Priority to US17/948,402 priority patent/US20230025774A1/en

Links

Images

Classifications

    • 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
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • 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
    • A61B17/0467—Instruments for cutting sutures
    • 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
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406—Pledgets
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • 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
    • A61B2017/0474—Knot pushers
    • 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
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488—Instruments for applying suture clamps, clips or locks
    • 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
    • A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

Definitions

  • This application relates to the technical field of medical devices, and in particular to a push-release type suture locking device.
  • An existing suture locking device includes a lock pin with a hollow inner cavity, a chuck matched with the lock pin and presses the lock pin to force the lock pin to deform, and a parallel connection between the chuck and the lock pin.
  • a push rod that provides a driving force for the chuck, a suture thread is inserted into the hollow cavity of the lock nail, and the push rod is pushed in the axial direction toward the distal end of the chuck to drive the chuck to implement the lock nail Pressing to lock the suture thread. After the locking nail is pressed, the push rod is pulled back in the opposite direction in the axial direction, so that the push rod gradually moves away from the chuck, so as to release the push rod against the chuck.
  • the force of the chuck causes the chuck to release the lock nail.
  • the direction of the force when the chuck presses the lock nail is opposite to the direction of the force when the lock nail is released.
  • the force curve of the push rod has forward and reverse cliff jumps.
  • the force of the chuck also has cliff jumping; the moment the push rod is pulled back and the chuck releases the lock nail, the push rod will drive the chuck and the lock nail to jump violently, which will forcefully tear the sutured The risk of tearing the tissue is higher.
  • the purpose of this application is to provide a push-release type suture locking device in view of the defects of the prior art, which can avoid the violent jump of the chuck when releasing the locking nail, and greatly reduce the risk of tissue tearing. .
  • the forward push release type suture locking device includes a chuck and a push rod assembly sleeved outside the chuck; the lock nail is accommodated at the distal end of the chuck, and the chuck itself has elasticity;
  • the push rod assembly includes a push rod, the side of the push rod facing the chuck is provided with a recess, and the side of the chuck facing the push rod is provided with a protrusion corresponding to the recess
  • the push rod first pushes against the side of the raised portion gradually increasing, so as to force the chuck to press the lock nail to deform and lock The suture; then the raised portion is gradually accommodated in the recessed portion, so that the chuck is at least partially restored to deform to release the lock nail.
  • a recess is provided on the chuck, and a protrusion is provided on the push rod.
  • the push rod first pushes against the side where the raised portion of the chuck gradually rises, so as to force the chuck to press the lock nail to deform and lock the suture thread inserted in the lock nail, and then the raised portion is gradually accommodated in the lock nail.
  • the chuck is at least partially deformed to release the lock nail, that is, the pressing and releasing of the lock nail is implemented by continuously pushing the push rod.
  • the whole pushing ensures the continuity of the force on the push rod and the chuck, and can avoid
  • the chuck releases the sudden violent jump of the lock nail to prevent the chuck and the lock nail from tearing the sutured tissue, thereby greatly reducing the risk of tissue tearing.
  • Fig. 1 is a schematic diagram of the relationship between the force and the stroke of the push rod in the process of pressing and releasing the lock nail of the chuck in the prior art.
  • FIG. 2 is a schematic diagram of the three-dimensional structure of the forward push-release type suture locking device provided by the first embodiment of the present application.
  • Fig. 3 is a cross-sectional view taken along the line III-III in Fig. 2.
  • Fig. 4 is an enlarged view of part IV in Fig. 3.
  • Fig. 5 is a three-dimensional structural schematic diagram of the locking nail squeezed by the chuck of the forward push-release type suture locking device provided by the first embodiment of the present application.
  • Fig. 6 is a cross-sectional view of the lock nail in Fig. 5.
  • Fig. 7 is a cross-sectional view of the lock nail in Fig. 5 after being pressed.
  • FIG. 8 is a schematic sectional view of the structure of the chuck in FIG. 4.
  • Fig. 9 is a schematic view of the deformed state of the chuck in Fig. 8.
  • FIG. 10 is a schematic diagram of the three-dimensional structure of the push rod assembly in FIG. 4.
  • Fig. 11 is a schematic sectional view of the push rod assembly in Fig. 10.
  • Fig. 12 is a cross-sectional view of the push rod assembly and the transmission assembly in Fig. 2.
  • Fig. 13 is a cross-sectional view of the chuck, the push rod assembly, the transmission assembly and the driving part in Fig. 2.
  • Fig. 14 is an enlarged view of the chuck, push rod assembly and part of the transmission assembly in Fig. 13.
  • Fig. 15 is a schematic diagram of the three-dimensional structure of the handle and outer support tube assembly in Fig. 2.
  • Fig. 16 is a cross-sectional view of part of the handle and outer support tube assembly in Fig. 15.
  • Figs. 17-19 are schematic diagrams of the valve repair process of the diseased tricuspid valve by the push-release suture locking device provided in the first embodiment of the present application.
  • Fig. 20 is an enlarged view of part XX in Fig. 19.
  • Figures 21 to 23 are schematic diagrams of the process of fixing the suture in the locking nail by the forward push-release type suture locking device provided by the first embodiment of the present application.
  • 24 is a schematic diagram of the relationship between the force and stroke of the push rod in the process of the chuck press-type locking nail and the release of the locking nail of the present application.
  • Fig. 25 is a schematic diagram of the structure of the forward push-release type suture locking device provided by the second embodiment of the present application.
  • proximal refers to the end far away from the operator during the surgical operation
  • proximal end refers to the end closer to the operator during the surgical operation
  • the proximal end in this application is relative to the distal end from the operator ( The distance between the surgeon) is relatively short.
  • Axial refers to the direction of the central axis of the device, and the radial direction is the direction perpendicular to the central axis. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the technical field of this application. Conventional terms used in the specification of this application are only for the purpose of describing specific embodiments, and should not be construed as limiting the application.
  • an element when an element is referred to as being “disposed on” another element, the element can be directly connected to the other element, or indirectly connected to the other element through one or more connecting elements.
  • an element When an element is referred to as being “connected to” another element, it can be directly connected to the other element or connected to the other element through one or more connecting elements.
  • the first embodiment of the present application provides a forward release type suture locking device 100 for locking the suture with the locking nail 300.
  • the forward push-release type suture locking device 100 includes a chuck 22 arranged at the distal end for compressing the locking nail 300 to deform it, a push rod assembly 40 sleeved outside the chuck 22 for controlling the opening and closing of the chuck 22,
  • the transmission assembly 60 connected to the push rod assembly 40, the drive member 70, the support tube assembly 80 surrounding the outside of the chuck 22, the push rod assembly 40 and the transmission assembly 60, and a handle 90 provided at the proximal end.
  • the distal end of the chuck 22 is provided with a gap 25 for placing the locking nail 300 (as shown in FIG.
  • the locking nail 300 is provided with a threading cavity 301 along the axial direction, and the threading cavity 301 is used for threading sutures.
  • the push rod assembly 40 includes a push rod 42 arranged outside the chuck 22. The side of the push rod 42 facing the chuck 22 is provided with a recess 420. The axial position of the chuck 22 is fixed and has elasticity.
  • a protrusion 220 corresponding to the recess 420 is provided on the side facing the push rod 42;
  • the transmission assembly 60 includes a threaded transmission member 62 and a flexible inner core 63 with a certain axial length fixedly connected to the threaded transmission member 62, and the threaded transmission member 62
  • the distal end is rotated to connect the push rod assembly 40;
  • the flexible inner core 63 rotates to drive the threaded transmission member 62 to rotate, and the rotation of the threaded transmission member 62 drives the push rod assembly 40 to move toward the distal end in the axial direction, so that the push rod 42 is in the axial direction Move to the distal end to push against the gradually raised side of the protrusion 220 of the chuck 22, thereby forcing the chuck 22 to press the lock nail 300 to deform and lock the suture thread inserted in the lock nail 300; the flexible inner core 63 Continue to rotate in the same direction to drive the threaded transmission member 62 to rotate.
  • the rotation of the threaded transmission member 62 drives the push rod assembly 40 and the push rod 42 to continue to move axially toward the distal end until the raised portion 220 of the chuck 22 is gradually accommodated in the recessed portion Within 420, the chuck 22 is at least partially deformed to release the lock nail 300.
  • the push rod 42 in the process of continuously pushing the push rod 42 toward the distal end in the axial direction, the push rod 42 first abuts the protrusion 220 of the push chuck 22 and gradually rises. On one side, to force the chuck 22 to press the lock pin 300 to deform to lock the suture thread inserted in the lock pin 300, and then the protrusion 220 on the chuck 22 is gradually accommodated in the recess 420 of the push rod 42.
  • the chuck 22 recovers at least part of its deformation to release the lock nail 300, that is, the pressing and releasing of the lock nail 300 is implemented by continuously pushing the push rod 42.
  • the whole pushing ensures the continuity of the push rod 42 and the chuck 22 (such as 24), it can avoid the violent jump of the chuck 22 at the moment when the lock nail 300 is released, and prevent the chuck 22 and the lock nail 300 from tearing the sutured tissues, such as valve leaflets, so as to greatly reduce the risk of tissue tearing.
  • the push rod 42 is pushed toward the distal end in the axial direction to push against the gradually raised side of the protrusion 220 of the push chuck 22.
  • the resistance gradually increases, and the push rod
  • the driving force required by 42 gradually increases; when the push rod 42 continues to advance in the axial direction toward the distal end and crosses the highest point of the protrusion 220, the protrusion 220 is gradually accommodated in the recess 420, and the resistance will gradually increase. Decrease, the driving force required by the push rod 42 is gradually reduced accordingly; thus, the operator can know whether the locking nail 300 has been pressed and whether the suture has been locked through the perception of the operating feel.
  • the forward push release type suture locking device 100 converts the rotational torque of the flexible inner core 63 and the threaded transmission member 62 into an axial thrust that the threaded transmission member 62 drives the push rod 42 to move axially, so as to drive the push rod. 42 is pushed forward in the axial direction. Because the threaded transmission member 62 is rigid and short in length, the thrust loss is minimal. The thrust can be smoothly and effectively transmitted to the push rod 42 to push the chuck 22, so that the chuck 22 can The effective compression of the lock nail 300 makes the lock nail 300 fully deform, and ensures that the suture thread is reliably locked by the lock nail 300.
  • the outer support tube assembly 80 includes a sleeve 82 for accommodating the collet 22 and the push rod assembly 40, an end cap 88 fixed to the distal end of the sleeve 82, and a proximal end of the sleeve 82.
  • the connecting barrel 84 and the flexible outer tube 86 fixed to the proximal end of the connecting barrel 84.
  • the threaded transmission member 62 is rotatably connected with the outer casing assembly 80, and the threaded transmission member 62 rotates relative to the outer casing assembly 80 to drive the push rod 42 to move in the axial direction.
  • the sleeve 82 houses the chuck 22 and the push rod assembly 40, the chuck 22 is fixedly connected to the sleeve 82 so that the axial position of the chuck 22 is fixed, and the flexible outer tube 86 is sleeved outside the flexible inner core 63.
  • the threaded transmission member 62 is rotatably connected in the connecting barrel 84. Specifically, the threaded transmission member 62 and the connecting barrel 84 are driven by screw coupling.
  • the threaded transmission member 62 is a transmission screw.
  • a connecting portion 67 is provided at the distal end of the threaded transmission member 62. The connecting portion 67 rotates and connects to the push rod assembly 40.
  • the threaded transmission member 62 rotates synchronously and moves axially to drive the push The rod assembly 40 moves in the axial direction.
  • the distal end of the flexible outer tube 86 is fixedly connected to the proximal end of the connecting cylinder 84, the connecting cylinder 84 is fixedly connected between the sleeve 82 and the flexible outer tube 86, and the proximal end of the flexible outer tube 86 is fixedly connected to the handle
  • the inner cavity of the flexible outer tube 86 communicates with the inner cavity of the connecting barrel 84, and the connecting barrel 84 is screwed to the threaded transmission member 62.
  • the flexible outer tube 86 is a tube body with a certain supporting force, preferably a tube body such as a laser cut outer tube, a spiral structure, or a woven mesh structure.
  • the flexible outer tube 86 adopts a laser cutting outer tube.
  • the flexible outer tube 86 may be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other materials.
  • the flexible outer tube 86 is made of nickel-titanium alloy.
  • the sleeve 82 is a hollow tube, the proximal end of the sleeve 82 is clamped to the distal end of the connecting cylinder 84, and the distal end of the sleeve 82 is clamped to the end cap 88.
  • a threading groove 820 is defined on the peripheral wall of the sleeve 82 near the chuck 22, and the threading groove 820 is used for the suture thread inserted in the lock nail 300 to pass through.
  • the distal end of the end cap 88 is provided with a suture inlet 880 communicating with the inner cavity of the sleeve 82, and the locking nail 300 is inserted into the inner cavity of the sleeve 82 through the suture inlet 880.
  • the locking nail 300 includes a locking cylinder 302 and a circular platform 303 provided at the distal end of the locking cylinder 302.
  • the outer diameter of the round table 303 of the locking nail 300 is larger than the outer diameter of the locking cylinder 302.
  • the threading cavity 301 of the locking nail 300 penetrates through opposite ends of the locking nail 300 in the axial direction, and the threading chamber 301 is used for receiving and passing suture thread.
  • the locking cylinder 302 can be compressed when subjected to mechanical external force to fix the suture thread in the threading cavity 301 of the locking nail 300.
  • the locking nail 300 can be in various shapes, for example, cylindrical, prismatic, elliptical, etc., as long as it has a threading cavity 301 for accommodating sutures.
  • the lock nail 300 is made of biocompatible materials such as stainless steel, pure titanium, nickel-titanium, and cobalt-chromium alloy, and is preferably made of pure titanium or stainless steel.
  • the initial height h1 of the middle of the lock nail 300 is equal to the outer diameter of the locking cylinder 302 of the lock nail 300; as shown in FIG. 6, the lock
  • the locking cylinder 302 of the nail 300 is compressed when subjected to mechanical external force, the suture is fixed in the threading cavity 301 of the locking nail 300.
  • the height h2 of the locking nail 300 after being compressed is less than the initial height h1 .
  • an anti-skid structure can also be provided on the inner peripheral surface of the threading cavity 301, such as anti-skid patterns or rough treatment on the inner peripheral surface of the threading cavity 301 After the lock nail 300 is deformed by the external pressing force, the friction between the suture thread and the inner peripheral surface of the threading cavity 301 increases, so that the suture thread is more firmly fixed in the threading cavity 301 of the lock nail 300.
  • the chuck 22 includes a first chuck 221 and a second chuck 223 that are integrally formed and disposed opposite to each other, and the protrusion 220 is provided on the side of the first chuck 221 away from the second chuck 223 .
  • the gap 25 is formed between the first chuck 221 and the second chuck 223.
  • the driving member 70 drives the threaded transmission member 62 to rotate
  • the threaded transmission member 62 moves axially while rotating and pushes the push rod 42 to move in the axial direction, that is, the rotation of the threaded transmission member 62 is transformed into
  • the axial movement of the push rod 42 causes the push rod 42 to slide against the protrusion 200 of the chuck member 22 to drive the first chuck 221 and the second chuck 223 to move closer together and squeeze the lock nail 300 to lock
  • the nail 300 is deformed and fixed with the suture.
  • the first chuck 221 and the second chuck 223 are integrally formed of elastic hard materials, the proximal end of the chuck 22 is closed, and the proximal end of the chuck 22 is penetrated by a vertical axis.
  • the pin 24 and the opposite ends of the pin 24 are respectively fixed to the sleeve 82.
  • the pin 24 positions the collet 22 and prevents the collet 22 from moving in the axial direction.
  • the physical part where the proximal ends of the first chuck 221 and the second chuck 223 are connected provides support and power for the first chuck 221 to rebound.
  • the protruding portion 220 is located at the distal end of the first chuck 221 facing away from the second chuck 223.
  • the protruding portion 220 includes a first outer inclined surface 2201 and a second outer inclined surface 2203 that intersect each other.
  • the inclined surface 2201 and the second outer inclined surface 2203 intersect one side away from the second chuck 223, the first outer inclined surface 2201 gradually rises from the proximal end to the distal end thereof, and the second outer inclined surface 2203 gradually decreases from the proximal end to the distal end thereof.
  • the first outer inclined surface 2201 corresponds to the side where the raised portion 220 gradually rises.
  • the distal end of the push rod 42 slidably pushes the first outer inclined surface 2201 in the axial direction to press
  • the chuck 221 gradually moves closer to the second chuck 223 to press the lock nail 300.
  • the chuck 22 rebounds, the first chuck 221 is away from the second chuck 223, the first chuck 221 and the second chuck 223
  • the gap between the chucks 223 is increased to be greater than the height h2 of the lock nail 300 after being collapsed, so as to release the lock nail 300.
  • the side of the distal end of the first chuck 221 facing the gap 25 is provided with first clamping teeth 2215.
  • the first clamping teeth 2215 include a plurality of tooth grooves, and each tooth groove extends in a direction substantially perpendicular to the axial direction.
  • the first outer inclined surface 2201 is located at the proximal end of the protrusion 220, and the first outer inclined surface 2201 gradually extends from the proximal end to the distal end to the side away from the second chuck 223;
  • the second outer inclined surface 2203 is located at the distal end of the protrusion 220, and the second outer inclined surface 2203 gradually extends obliquely to the side close to the second chuck 223 from the proximal end to the distal end.
  • the first outer inclined surface 2201 and the second outer inclined surface 2203 of the protruding portion 220 form an included angle a, and preferably, 120° ⁇ a ⁇ 180°.
  • the first outer inclined surface 2201 and the vertical plane L perpendicular to the axial direction The angle range of the first included angle a1 between is 70° ⁇ a1 ⁇ 90°, and the angle range of the second included angle a2 between the second outer inclined surface 2203 and the vertical plane L perpendicular to the axial direction is 50° ⁇ a2 ⁇ 90°, the sum of the first included angle a1 and the second included angle a2 is equal to the included angle a between the first outer inclined surface 2201 and the second outer inclined surface 2203.
  • the slope of the first outer slope 2201 is smaller than the slope of the second outer slope 2203, and the slope of the first outer slope 2201 is relatively gentle, which helps to reduce the push rod 42 so that The push rod 42 resists and presses the driving force of the chuck 22 to allow the chuck 22 to gradually deform.
  • the height difference H1 between the distal end and the proximal end of the first outer inclined surface 2201 is greater than or equal to the inner hole of the locking cylinder 302 of the lock pin 300, that is, the diameter of the threading cavity 301, and is smaller than the lock pin of the lock pin 300
  • the outer diameter of the cylinder 302 so that when the push rod 42 is pressed against the distal end of the first outer inclined surface 2201, the first chuck 221 and the second chuck 223 can fully press the lock nail 300 to lock the penetration hole in the lock. Staple the suture within 300.
  • the height difference H between the highest point of the protrusion 220 before the deformation of the first chuck 221 and after the deformation and rebound is completed is less than the initial height h1 of the lock nail 300 and after compression The difference in height h2.
  • the vertical length between the highest point of the protrusion 220 and the axial plane of the pin 24 is H2 (as shown in FIG. 8), and the first chuck 221 is pressed back After the bullet ends, the raised portion 220 is accommodated in the recessed portion 420 of the push rod 42.
  • the vertical length between the highest point of the raised portion 220 and the axial plane through the axis of the pin 24 is H3 (as shown in Figure 9). Show), H2 minus H3 to obtain the height difference H, the height difference H is less than the difference between the initial height h1 of the lock nail 300 before pressing and the height h2 of the lock nail 300 after pressing, so as to facilitate the lock nail 300 smoothly escapes from the gap 25 of the chuck 22; when the difference H is 0, the first chuck 221 is completely restored to the initial state.
  • the arc transition at the intersection of the first outer inclined surface 2201 and the second outer inclined surface 2203 facilitates the push rod 42 to smoothly cross the intersection of the first outer inclined surface 2201 and the second outer inclined surface 2203, which is convenient for the push rod 42 to move from the first outer inclined surface. 2201 slides smoothly onto the second outer inclined surface 2203.
  • the second chuck 223 faces the side of the first chuck 221 and is provided with a second clamping tooth 2235 adjacent to the distal end.
  • the second clamping tooth 2235 includes a plurality of tooth grooves. The extending directions of the tooth grooves of a clamping tooth 2215 are the same.
  • the first clamping teeth 2215 of the first chuck 221 and the second clamping teeth 2235 of the second chuck 223 are misaligned and can mesh with each other, therefore,
  • the first chuck 221 is elastically deformed to move closer to the second chuck 223, and the first clamping teeth 2215 and the second clamping teeth 2235 squeeze the lock nail 300 placed in the gap 25 into a shape having a curvature.
  • the proximal end of the second chuck 223 away from the side of the first chuck 221 is provided with a horizontal sliding guide surface 2236.
  • the sliding guide surface 2236 is provided with a threading hole 2237 communicating with the gap 25 to facilitate self-threading of the suture after passing through the lock nail 300 Hole 2237 penetrated.
  • a positioning block 2233 protrudes from the distal end of the second chuck 223 facing away from the side of the first chuck 221, the proximal surface of the positioning block 2233 is close to the threading hole 2237, and the proximal surface of the positioning block 2233 is a tangent surface 2238.
  • the push rod assembly 40 also includes a base 44 movably installed in the sleeve 82 in the axial direction, and a tangent blade 46 fixedly connected to one side of the base 44.
  • the push rod The proximal end of 42 is fixedly connected to the other side of the base 44 opposite to the tangent blade 46, and the push rod 42 extends axially to the distal end.
  • the connecting portion 67 rotates to connect to the base 44, and an axial limiting structure is provided between the connecting portion 67 and the base 44.
  • the thread cutting blade 46 is arranged opposite to the push rod 42 at intervals, and the thread cutting blade 46 slides on the sliding guide surface 2236 in the axial direction.
  • the recess 420 is provided on a side of the push rod 42 close to the first chuck 221 and close to the distal end of the push rod 42.
  • the recess 420 includes a first inner inclined surface 4201 and a second inner inclined surface 4203 that intersect each other.
  • the first inner inclined surface 4201 is farther away from the distal end surface of the push rod 42 than the second inner inclined surface 4203.
  • the first outer inclined surface 2201 corresponds to the first inner inclined surface 4201
  • the second outer inclined surface 2203 corresponds to the second inner inclined surface 4203.
  • the first inner inclined surface 4201 gradually extends from the proximal end to the distal end to the side away from the first chuck 221, and the second inner inclined surface 4203 gradually approaches the first clamp from the proximal end to the distal end.
  • One side of the head 221 extends obliquely.
  • the distal edge of the second outer inclined surface 4203 has a circular arc transition so that the push rod 42 smoothly abuts against the second outer inclined surface 2203; the arc between the distal end surface of the push rod 42 and the surface of the push rod 42 close to the chuck 22 Transition, so that the push rod 42 slides smoothly against the first outer inclined surface 2201.
  • the included angle b between the first inner inclined surface 4201 and the second inner inclined surface 4203 of the concave portion 420 is greater than or equal to the included angle a between the first outer inclined surface 2201 and the second outer inclined surface 2203 of the convex portion 220 to facilitate convexity.
  • the raised portion 220 is accommodated in the recessed portion 420.
  • the third included angle b1 between the first inner inclined surface 4201 and the vertical plane O perpendicular to the axial direction is greater than or equal to the first included angle a1
  • the second inner inclined surface 4203 is opposite to the vertical plane perpendicular to the axial direction.
  • the fourth included angle b2 between the surfaces O is greater than or equal to the second included angle a2; the sum of the third included angle b1 and the fourth included angle b2 is equal to the included angle b between the first inner inclined surface 4201 and the second inner inclined surface 4203 .
  • the maximum depth H4 of the recessed portion 420 is the vertical length from the highest point of the recessed portion 420 to the surface of the push rod 42 close to the chuck 22, and the maximum depth H4 is greater than or equal to the first outer slope 2201.
  • the height difference H1 between the end and the proximal end, or the maximum height value of the protrusion 220 ensures that the protrusion 220 can be completely contained in the recess 420, and provides sufficient rebound space for the chuck 22;
  • the height of the gap 25 is greater than the height h2 of the lock nail 300 after being compressed, so as to facilitate the release of the lock nail 300.
  • a cutting edge 461 is provided at the distal end of the thread cutting blade 46.
  • the cutting edge 461 abuts the cutting surface 2238 to cut the suture passing through the threading hole 2237.
  • the shape of the protrusion 220 may also be a hemisphere, truncated cone, cone, etc.
  • the shape of the recess 420 may also be a hemisphere, Grooves or vacancies in the shape of truncated cones and cones.
  • the flexible inner core 63 includes a flexible inner tube 64 connected to the proximal end of the threaded transmission member 62 and a core rod 66 inserted into the inner cavity of the flexible inner tube 64.
  • the connecting portion 67 is connected between the distal end of the threaded transmission member 62 and the base 44 of the push rod assembly 40.
  • the flexible inner tube 64 is wound on the core rod 66, and the flexible inner tube 64 and the core rod 66 together constitute the flexible inner core 63.
  • the threaded transmission member 62 includes a transmission screw rod 621, and the transmission screw rod 621 is screwed to the internal thread of the connecting barrel 84.
  • the distal end of the flexible inner tube 64 is fixedly connected to the threaded transmission member 62, and the proximal end of the flexible inner tube 64 is fixedly connected to the driving member 70, and the driving member 70 is used to drive the flexible inner core 63 and the threaded transmission member 62 to rotate.
  • the flexible inner tube 64 is a tube body with a certain supporting force, preferably a tube body such as a spiral structure or a woven mesh structure, and can be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other materials.
  • the outer diameter of the flexible inner tube 64 is smaller than the inner diameter of the flexible outer tube 86.
  • the core rod 66 is inserted into the inner cavity of the flexible inner tube 64.
  • the core rod 66 is a core rod with certain flexibility.
  • the core rod 66 may be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other materials. The provision of the core rod 66 can facilitate the winding of wires thereon to form the flexible inner tube 64 and enhance the torsion control of the flexible inner core 63.
  • the drive screw 621 rotates and moves in the axial direction to drive the connecting portion 67 to rotate relative to the base 44, and at the same time, the distal end of the drive screw 621 pushes the base 44, the push rod 42, and the cutting blade 46 in the axial direction. Move remotely.
  • the connecting portion 67 may also be fixedly connected to the push rod assembly 40, the connecting portion 67 is rotatably connected to the threaded transmission member 62, and the connecting portion 67 and the threaded transmission member 62 are provided with a preventing connection portion 67 relative to the thread.
  • the limiting structure in which the transmission member 62 moves in the axial direction makes the connecting portion 67 and the threaded transmission member 62 rotatably connected.
  • the driving member 70 is connected to the proximal end of the transmission assembly 60.
  • the driving member 70 is a rotating member rotatably disposed at the proximal end of the handle 90, the flexible inner tube 64 and the core rod 66
  • the proximal end is fixedly connected to the driving member 70.
  • the rotation of the driving member 70 drives the flexible inner tube 64 and the core rod 66 to rotate together.
  • the outer wall of the driving member 70 is provided with an anti-skid mechanism 79, and the anti-skid mechanism 79 is held by hand to facilitate the rotation of the driving member 70.
  • the driving member 70 is rotatably connected to the proximal end of the handle 90.
  • the handle 90 is adjacent to the driving member 70 and is provided with at least one length scale 915 and at least one length scale 915 along the axial direction. It is used to display the displacement amount of the driving member 70 moving in the axial direction.
  • the first chuck 221 and the second chuck 223 of the chuck 22 are in a fully opened state, and the push rod 42 does not apply an edge to the chuck 22 Axial thrust;
  • the driving member 70 rotates and moves in the axial direction to a certain scale value on the length scale 915, such as "6"
  • the push rod 42 pushes against the protrusion of the chuck 22
  • the first chuck 221 and the second chuck 223 squeeze the lock nail 300 to deform and fix the suture thread inserted in the lock nail 300;
  • the driving member 70 continues to rotate in the same direction and moves to the axial direction
  • another scale value on the length scale 915 such as "7.5"
  • the protrusion 220 on the chuck 22 is accommodated in the recess 420 of the push rod 42, and the first clamp of the chuck 22
  • the head 221 is partially elastically reset and away from
  • FIGS. 17 to 23 Please refer to FIGS. 17 to 23.
  • the following uses a tricuspid valve repair operation as an example to illustrate the use process of the forward release suture locking device 100 provided in the present application.
  • the tricuspid valve is a one-way "valve" between the right atrium (abbreviation: RA) and the right ventricle (abbreviation: RV), which can ensure blood flow from the right atrium to the right ventricle.
  • RA right atrium
  • RV right ventricle
  • a normal healthy tricuspid valve has multiple chordae.
  • the leaflets of the tricuspid valve are divided into anterior leaflets, posterior leaflets and septal leaflets.
  • the three When the right ventricle is in a diastolic state, the three are in an open state, and blood flows from the right atrium to the right ventricle; when the right ventricle is in a contracted state, the chordae tendons are pulled Extend to ensure that the valve leaflets will not be rushed to the atrium side by blood flow, and the anterior leaflets, posterior leaflets and septal leaflets are closed well, thus ensuring that blood flows from the right ventricle to the pulmonary artery through the pulmonary valve (referred to as PV). If the tricuspid valve is diseased, when the right ventricle is in a contracted state, the tricuspid valve cannot return to a fully closed state as in the normal state, but insufficiency occurs.
  • an interventional method can be used to implant sutures on each leaflet, and then use the locking device in this application to lock the sutures on each leaflet together to implement edge-to-edge repair. The process is as follows:
  • the first step as shown in Figure 17, firstly, one or more sutures 500 with elastic spacers 501 are implanted into the anterior, posterior and septal leaflets of the tricuspid valve of the patient. The point contact between the leaflets is converted into the surface contact between the elastic gasket 501 and the leaflets, which can effectively reduce the risk of leaflet tearing;
  • Step 2 As shown in Figure 17 and Figure 21, the multiple sutures 500 on the three valve leaflets are inserted into the threading cavity 301 of the locking nail 300 of the forward release suture locking device 100 outside the patient's body , And pass the proximal end of the suture 500 through the threading cavity 301 of the lock nail 300, the gap 25 between the first chuck 221 and the second chuck 223, and the threading hole 2237 in turn, and pass through the threading groove 820 of the sleeve 82 ;
  • Step 3 Push the distal end of the forward release suture locking device 100 through the femoral vein into the right atrium of the heart with the help of a bending sheath (not shown), move it closer to the leaflets of the tricuspid valve, and pull the suture at the same time Thread 500 until the distal end of the push-release suture locking device 100 reaches the predetermined position in the right atrium;
  • Step 4 Adjust the tightness of the sutures 500 of the front, back, and septal leaflets respectively, and determine the lightest state of tricuspid regurgitation through ultrasound. When this state is reached, stop the adjustment and maintain the three sets of sutures The tightness of the line 500, that is, maintaining the relative position between the anterior, posterior and septal leaflets of the tricuspid valve;
  • Step 5 As shown in Figure 18 and Figure 22, rotate the drive member 70 on the handle 90, the threaded drive member 62 moves to the distal end along the axial direction while rotating, driving the drive member 70, the flexible inner core 63 and the threaded drive member 62 moves toward the distal end in the axial direction while rotating, the threaded transmission member 62 abuts the push rod assembly 40 and moves toward the distal end in the axial direction.
  • the push rod assembly 40 moves along the axial distal end, the push rod 42 is relative to the chuck.
  • the distal end of the push rod 42 moves to the distal end, and the distal end of the push rod 42 continuously pushes and squeezes the first outer inclined surface 2201 on the first chuck 221 until it reaches the highest point of the protrusion 220, so that the first chuck 221 faces
  • the second chuck 223 is moved closer, the first clamping teeth 2215 and the second clamping teeth 2235 press and hold the lock nail 300 contained in the gap 25 until the lock nail 300 is deformed, and the three sets of sutures 500 in the lock nail 300 are locked.
  • Step 6 As shown in Figure 19, Figure 20 and Figure 23, continue to rotate the drive member 70 on the handle 90 in the same direction of rotation, the threaded drive member 62 continues to move axially to the distal end, and the push rod 42 continues to move toward Move the distal end until the protrusion 220 on the first chuck 221 enters the recess 420 of the push rod 42, the chuck 22 releases the lock pin 300, the cutting blade 46 cuts the suture 500, and the lock pin 300 comes from the chuck 22 Release from the gap 25; then pull the excess suture 500 out of the patient's body through the locking path;
  • Step 7 Withdraw the distal end of the locking device 100 out of the patient's body, and the locking nail 300 is left in the patient's body. At this time, the locking nail 300 will fix the three sets of sutures passing through the anterior lobe, posterior lobe and septal lobe together. The anterior, posterior and septal leaflets of the tricuspid valve were repaired.
  • the above-mentioned only the push-release suture locking device is used for the interventional tricuspid valve repair process as an example to illustrate its use process.
  • the push-release suture locking device of the present application can also be used for Locking and fixing of sutures during other operations.
  • the structure of the forward push-release type suture locking device provided by the second embodiment of the present application is similar to the structure of the first embodiment, except for the push rod assembly 40a and the thread in the second embodiment.
  • the structure of the transmission member 62a is slightly different from that of the first embodiment, and the connection structure of the push rod assembly 40a and the threaded transmission member 62a is slightly different from that of the first embodiment, specifically as follows:
  • the forward push release type suture locking device in the second embodiment also includes the chuck 22, the push rod assembly 40a, the transmission assembly and the outer cover assembly 80a.
  • the rod assemblies 40a are threaded for transmission, and the threaded transmission part 62a only rotates. The rotation of the threaded transmission part 62a is converted into the axial movement of the push rod 42 through the threaded transmission between the threaded transmission part 62a and the push rod assembly 40a.
  • the threaded transmission member 62a includes a transmission screw 621 at the distal end and a connecting rod 625 extending axially from the proximal end of the self-driving screw 621, and a stop ring 627 is radially provided on the outer wall of the proximal end of the transmission screw 621.
  • the base 44a of the push rod assembly 40a in the second embodiment is provided with a screw hole 444 on the basis of the structure of the push rod assembly 40 in the first embodiment, and the driving screw rod 621 is screwed with the screw hole 444.
  • the sleeve assembly 80a omits the connecting barrel of the sleeve assembly 80 in the first embodiment.
  • An annular flange 842 is provided on the inner wall of the sleeve 82 corresponding to the threaded transmission member 62a.
  • the proximal end of the threaded transmission member 62a is rotatably inserted into the flange 842 Inside, the outer peripheral wall of the threaded transmission member 62a is provided with a stop ring 627 at the distal end of the flange 842, and the threaded transmission member 62a is fixedly connected to a fixed ring 68 at the proximal end of the flange 842.
  • the stop ring 627 and the fixed ring 68 are enclosed In the rotating groove, the flange 842 is rotatably received in the rotating groove, and the distal end of the flexible outer tube 86 is fixedly connected to the proximal end of the sleeve 82. Since the stop ring 627 stops at the distal end surface of the flange 842 and the fixed ring 68 stops at the proximal end surface of the flange 842, the connecting rod 625 and the threaded transmission member 62a can only rotate, and cannot move in the axial direction.
  • the use of the forward push release type suture locking device of the second embodiment is similar to that of the first embodiment, except that the driving part on the rotating handle is rotated, and the rotation of the driving part drives the flexible inner core and the threaded transmission part 62 in place Rotating, the base 44a drives the push rod 42 to move distally relative to the chuck 22.

Landscapes

  • 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)
  • Rheumatology (AREA)
  • Surgical Instruments (AREA)

Abstract

一种前推释放型缝合线锁结装置（100），用于将缝合线（500）固定在锁钉（300）中，包括夹头（22）及套设于夹头（22）外的推杆组件（40）；锁钉（300）容置在夹头（22）的远端，夹头（22）自身具有弹性；推杆组件（40）包括推杆（42），推杆（42）面朝夹头（22）的一侧设有凹陷部（420），夹头（22）面朝推杆（42）的一侧设置对应凹陷部（420）的凸起部（220）；在推杆（42）沿轴向持续朝远端移动的过程中，推杆（42）先抵推凸起部（220）逐渐升高的一侧，以迫使夹头（22）压迫锁钉（300）变形而锁紧缝合线（500）；之后凸起部（220）逐渐容置于凹陷部（420）内，使得夹头（22）至少恢复部分形变，以释放锁钉（300）。该前推释放型缝合线锁结装置（100），能够避免夹头（22）释放锁钉（300）瞬间的剧烈跳动，大幅降低组织被撕裂的风险。

Description

前推释放型缝合线锁结装置 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种前推释放型缝合线锁结装置。
背景技术
在手术中经常需要对缝合线进行打结并固定的操作步骤，传统外科手术是在开刀直视条件下操作，通常由医生手动打结。但是随着技术的进步，各种微创手术及介入手术日益普遍，例如腔镜下手术、经导管介入手术等。这些手术只需在患者身体上切开较小的操作窗口，由此将内窥镜或介入导管等器械伸入患者体内，到达预定位点进行治疗。在这类手术中，如需对患者体内的缝合线进行打结或固定操作，通常需要操作者通过所述较小的操作窗口在患者体外进行操作来对患者体内的缝合线进行打结或固定，这就需要用到缝合线锁结装置。
现有的一种缝合线锁结装置，包括具有中空内腔的锁钉、与锁钉配套并对所述锁钉施加压力以迫使所述锁钉变形的夹头，以及连接所述夹头并为所述夹头提供驱动力的推杆，所述锁钉的中空内腔内穿设有缝合线，通过沿轴向朝夹头远端前推所述推杆来驱动夹头对锁钉实施压型以锁紧缝合线，所述锁钉压型完成后再沿轴向反方向后拉所述推杆，使得所述推杆逐渐远离所述夹头，以解除所述推杆对所述夹头的施力，从而使得所述夹头释放锁钉。如图1所示，由于驱动推杆使得所述夹头压型锁钉时力的方向与释放所述锁钉时力的方向相反，推杆的受力曲线存在正、反向的断崖式跳跃，所述夹头的受力情况亦存在断崖式跳跃；所述推杆受拉后撤、夹头释放锁钉的瞬间，推杆会带动夹头及锁钉剧烈跳动，从而会大力撕扯被缝合的组织，该组织被撕裂的风险性较高。
发明内容
有鉴于此，本申请的目的在于，针对现有技术的缺陷，提供一种前推释放型缝合线锁结装置，能够避免夹头释放锁钉瞬间的剧烈跳动，大幅降低组织被撕裂的风险。
为了解决上述技术问题，本申请提供了一种前推释放型缝合线锁结装置，用于将缝合线固定在锁钉中。该前推释放型缝合线锁结装置包括夹头及套设于所述夹头外的推杆组件；所述锁钉容置在所述夹头的远端，所述夹头自身具有弹性；所述推杆组件包括推杆，所述推杆面朝所述夹头的一侧设有凹陷部，所述夹头面朝所述推杆的一侧设置对应所述凹陷部的凸起部；在所述推杆沿轴向持续朝远端移动的过程中，所述推杆先抵推所述凸起部逐渐升高的一侧，以迫使所述夹头压迫锁钉变形而锁紧所述缝合线；之后所述凸起部逐渐容置于所述凹陷部内，使得所述夹头至少恢复部分形变，以释放所述锁钉。
本申请提供的前推释放型缝合线锁结装置，在夹头上设置凹陷部，在推杆上设置凸起部，在持续地沿轴向朝远端推动所述推杆的过程中，所述推杆先抵推所述夹头的凸起部逐渐升高的一侧，以迫使夹头压迫锁钉变形而锁紧穿设于锁钉内的缝合线，然后凸起部逐渐 容置于凹陷部内，所述夹头至少恢复部分形变以释放锁钉，即通过持续地推动推杆来实施锁钉的压型与释放，全程推动保证了推杆及夹头受力的连续性，能够避免夹头释放锁钉瞬间的剧烈跳动，防止夹头及锁钉大力撕扯被缝合的组织，从而大幅降低组织被撕裂的风险。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是现有技术下夹头压型锁钉与释放锁钉过程中，推杆的受力与行程的关系示意图。
图2是本申请第一实施例提供的前推释放型缝合线锁结装置的立体结构示意图。
图3是图2中沿III-III线的剖视图。
图4是图3中IV部分的放大图。
图5是本申请第一实施例提供的前推释放型缝合线锁结装置的夹头所挤压的锁钉的立体结构示意图。
图6是图5中的锁钉的剖视图。
图7是图5中的锁钉压型后的剖视图。
图8是图4中的夹头的剖视结构示意图。
图9是图8中的夹头的变形状态示意图。
图10是图4中的推杆组件的立体结构示意图。
图11是图10中推杆组件的剖视结构示意图。
图12是图2中的推杆组件及传动组件的剖视图。
图13是图2中的夹头、推杆组件、传动组件及驱动件的剖视图。
图14是图13中的夹头、推杆组件及部分传动组件的放大图。
图15是图2中的手柄与外支撑管组件的立体结构示意图。
图16是图15中的部分手柄及外支撑管组件的剖视图。
图17-图19是本申请第一实施例提供的前推释放型缝合线锁结装置用于病变三尖瓣的瓣膜修复过程的示意图。
图20是图19中XX部分的放大图。
图21-图23是本申请第一实施例提供的前推释放型缝合线锁结装置将缝合线固定在锁钉内的过程示意图。
图24是本申请的夹头压型锁钉与释放锁钉过程中，推杆的受力与行程的关系示意图。
图25是本申请第二实施例提供的前推释放型缝合线锁结装置的结构示意图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本 申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或者暗示所指的装置或者元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性。
为了更加清楚地描述导线锁定***及导线锁定装置的结构，本申请所述的限定术语“近端”、“远端”及“轴向”为介入医疗领域惯用术语。具体而言，“远端”表示手术操作过程中远离操作人员的一端；“近端”表示手术操作过程中靠近操作人员的一端；本申请中的所述近端相对于远端距离操作者(外科医生)的距离较近，装置组装后，其中的每个部件均包括近端与远端，其中每个部件的近端相对远端距离操作者较近。“轴向”指装置中轴线所在方向，径向为与中轴线垂直的方向。除非另有定义，本申请所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本申请在说明书中所使用的惯用术语只是为了描述具体实施例的目的，并不能理解为对本申请的限制。
需要说明的是，当元件被称为“设置于”另一个元件上时，该元件可以直接地连接在另一个元件上，也可以通过一个或者多个连接元件间接地连接在另一个元件上。当一个元件被称为是“连接于”另一个元件时，它可以是直接地连接到另一个元件上，或者通过一个或者多个连接元件连接到另一元件上。
请参阅图2至图4，本申请第一实施例提供一种前推释放型缝合线锁结装置100，用于缝合线与锁钉300的锁结。该前推释放型缝合线锁结装置100包括设于远端用于压迫锁钉300使其变形的夹头22、套设于夹头22外用于控制夹头22开合的推杆组件40、连接于推杆组件40的传动组件60、驱动件70、围设于夹头22、推杆组件40及传动组件60的外部的支撑管组件80，及设置于近端的手柄90。夹头22的远端设置有用于放置锁钉300的空隙25(见图8所示)，锁钉300沿轴向设有穿线腔301，穿线腔301用于穿设缝合线。推杆组件40包括设于夹头22外的推杆42，推杆42面朝夹头22的一侧设有凹陷部420，夹头22的轴向位置固定且自身具有弹性，夹头22面朝推杆42的一侧设有对应凹陷部420的凸起部220；传动组件60包括螺纹传动件62及固定连接螺纹传动件62的具有一定轴向长度的柔性内芯63，螺纹传动件62的远端转动连接推杆组件40；柔性内芯63旋转以带动螺纹传动件62旋转，螺纹传动件62的旋转驱使推杆组件40沿轴向朝远端移动，以使得推杆42沿轴向朝远端移动以抵推夹头22的凸起部220逐渐升高的一侧，从而迫使夹头22压迫锁钉300变形而锁紧穿设于锁钉300内的缝合线；柔性内芯63继续同方向旋转以带动螺纹传动件62旋转，螺纹传动件62的旋转驱使推杆组件40及推杆42继续沿轴向朝远端移动至夹头22的凸起部220逐渐容置于凹陷部420内，使得夹头22至少恢复部分形变，以释放锁钉300。
本申请提供的前推释放型缝合线锁结装置100，在持续地沿轴向朝远端推动推杆42的 过程中，推杆42先抵推夹头22的凸起部220逐渐升高的一侧，以迫使夹头22压迫锁钉300变形而锁紧穿设于锁钉300内的缝合线，然后夹头22上的凸起部220逐渐容置于推杆42的凹陷部420内，夹头22至少恢复部分形变以释放锁钉300，即通过持续地推动推杆42来实施锁钉300的压型与释放，全程推动保证了推杆42及夹头22受力的连续性(如图24所示)，能够避免夹头22释放锁钉300瞬间的剧烈跳动，防止夹头22及锁钉300大力撕扯被缝合的组织，如瓣叶，从而大幅降低组织被撕裂的风险。
进一步地，推杆42沿轴向向远端推进以抵推夹头22的凸起部220逐渐升高的一侧，实施锁钉300压型的过程中，阻力是逐渐变大的，推杆42所需的驱动力相应逐渐增大；当推杆42继续沿轴向朝远端推进而越过凸起部220的最高点后，凸起部220逐渐容置于凹陷部420内，阻力会逐渐降低，推杆42所需的驱动力相应逐渐降低；从而，操作者通过对操作手感的感知就可以知道锁钉300是否已经完成压型、缝线是否已经被锁结。
另一方面，该前推释放型缝合线锁结装置100将柔性内芯63及螺纹传动件62的旋转扭矩转变成螺纹传动件62带动推杆42轴向移动的轴向推力，以驱动推杆42沿轴向向远端推进，由于螺纹传动件62是刚性的、长度较短，推力损耗极少，推力可顺畅及有效地传递给推杆42以抵推夹头22，从而夹头22能够有效压迫锁钉300使得锁钉300变形充分，保证缝合线被锁钉300可靠地锁紧。
如图3及图4所示，外支撑管组件80包括用于收容夹头22及推杆组件40的套筒82、与套筒82远端固定的端盖88、与套筒82近端固定的连接筒84，以及与连接筒84近端固定的柔性外管86。螺纹传动件62与外套组件80之间转动连接，螺纹传动件62相对于外套组件80转动以带动推杆42沿轴向移动。套筒82内容置夹头22及推杆组件40，夹头22固定连接套筒82以使得夹头22的轴向位置固定，柔性外管86套设于柔性内芯63外。螺纹传动件62可转动地连接于连接筒84内，具体地，螺纹传动件62与连接筒84之间通过螺纹配合传动。本实施例中，螺纹传动件62是传动丝杆，螺纹传动件62的远端设置一连接部67，连接部67转动连接推杆组件40，螺纹传动件62同步旋转及轴向移动以驱使推杆组件40沿轴向移动。
如图4所示，柔性外管86的远端固定连接于连接筒84近端，连接筒84固定连接于套筒82与柔性外管86之间，柔性外管86的近端固定连接于手柄90的远端，柔性外管86的内腔连通连接筒84的内腔，连接筒84与螺纹传动件62螺接。柔性外管86是具有一定支撑力的管体，优选激光切割外管、螺旋结构或编织网结构等管体。本实施例中，柔性外管86采用激光切割外管。柔性外管86可以由不锈钢、镍钛合金、钴铬合金等材料制成，本实施例中，柔性外管86采用镍钛合金。
套筒82是中空管，套筒82的近端卡接于连接筒84的远端，套筒82的远端卡接于端盖88。套筒82的周壁靠近夹头22处开设穿线槽820，穿线槽820供穿设于锁钉300内的缝合线穿出。端盖88的远端开设连通套筒82的内腔的缝合线入口880，锁钉300经缝合线入口880***套筒82的内腔。
请参阅图5及图6，锁钉300包括锁结筒302及设于锁结筒302远端的圆台303。锁钉 300的圆台303外径大于锁结筒302的外径。锁钉300的穿线腔301沿轴向穿通锁钉300相对的两端，穿线腔301用于容纳并通过缝合线。锁结筒302受到机械外力作用时可被压瘪，以将缝合线固定在锁钉300的穿线腔301中。锁钉300可以是多种形状，例如，圆柱形、棱柱形、椭圆形等，只要具有穿线腔301用于容纳缝合线即可。锁钉300的穿线腔301远端开口与锁钉300的远端面之间光滑过渡，避免二者之间的连接处切割缝合线或划伤患者身体内部组织。锁钉300由不锈钢、纯钛、镍钛、钴铬合金等生物相容性材料制成，优选由纯钛或不锈钢制成。
本实施例中，如图6所示，锁钉300在没有受到外力压瘪时，锁钉300中部的初始高度h1等于锁钉300的锁结筒302的外径；如图6所示，锁钉300的锁结筒302在受到机械外力作用时被压瘪时，缝合线固定在锁钉300的穿线腔301内，此时，锁钉300被压瘪后的高度h2小于所述初始高度h1。
为了提高被压握后的锁钉300与缝合线之间的连接力，还可以在穿线腔301的内周面上设置防滑结构，如在穿线腔301的内周面上设置防滑纹或粗糙处理，在锁钉300受到外部的压握力作用变形后，缝合线与穿线腔301的内周面的摩擦力增大，使缝合线被更加牢固地固定在锁钉300的穿线腔301中。
请参阅图8及图9，夹头22包括一体成型且相对设置的第一夹头221及第二夹头223，凸起部220设于第一夹头221背离第二夹头223的一侧。空隙25形成于第一夹头221与第二夹头223之间。当驱动件70驱动螺纹传动件62旋转，由于所述连接筒84的位置固定，螺纹传动件62边旋转边轴向移动并推动推杆42沿轴向移动，即螺纹传动件62的旋转转化为推杆42的轴向移动，使推杆42滑动地抵推夹头件22的凸起部200，以带动第一夹头221与第二夹头223相向靠拢并挤压锁钉300，使锁钉300变形与缝合线固定。
本实施例中，第一夹头221与第二夹头223由具有弹性的硬质材料一体成型制成，夹头22的近端封闭且夹头22近端内穿设一垂直于轴向的销钉24，销钉24相对的两端均分别固定至套筒82。销钉24定位夹头22，阻止夹头22沿轴向移动。第一夹头221与第二夹头223的近端连接的实体部位为第一夹头221回弹提供支撑及动力。
本实施例中，凸起部220位于第一夹头221背离第二夹头223的一侧的远端，凸起部220包括相交的第一外斜面2201及第二外斜面2203，第一外斜面2201及第二外斜面2203远离第二夹头223的一侧相交，第一外斜面2201自其近端向远端逐渐升高，第二外斜面2203自其近端向远端逐渐降低。如图4及图9所示，第一外斜面2201即对应凸起部220逐渐升高的一侧，推杆42的远端沿轴向滑动地抵推第一外斜面2201，来压迫第一夹头221逐渐地向第二夹头223靠拢，以压型锁钉300。继续向远端推动推杆42，直至凸起部220逐渐地容置于凹陷部420内，夹头22回弹，第一夹头221远离第二夹头223，第一夹头221与第二夹头223之间的间隙增大到大于锁钉300被压瘪后的高度h2，以释放锁钉300。进一步地，第一夹头221远端朝向空隙25的侧面设有第一夹齿2215，第一夹齿2215包括若干齿槽，每一齿槽沿大致垂直于轴向方向延伸。
如图8所述，第一外斜面2201位于凸起部220的近端，第一外斜面2201自其近端向 远端逐渐向远离第二夹头223的一侧倾斜延伸；第二外斜面2203位于凸起部220的远端，第二外斜面2203自近端向远端逐渐向靠近第二夹头223的一侧倾斜延伸。凸起部220的第一外斜面2201与第二外斜面2203之间呈夹角a，优选的，120°≤a＜180°。进一步地，夹头22处于初始状态(或称为自然状态，是指夹头22未被推杆42抵推前的状态)时，第一外斜面2201与垂直于轴向的竖直面L之间的第一夹角a1的角度范围为70°≤a1＜90°，第二外斜面2203与垂直于轴向的竖直面L之间的第二夹角a2的角度范围为50°≤a2＜90°，第一夹角a1与第二夹角a2之和等于第一外斜面2201与第二外斜面2203之间的夹角a。值得注意的是，a2＜a1，或者说第一外斜面2201的斜度小于第二外斜面2203的斜度，第一外斜面2201的斜度较平缓，有助于减小推动推杆42使得推杆42抵推及压迫夹头22的驱动力，允许夹头22逐渐变形。
如图8所示，第一外斜面2201远端与近端的高度差值H1大于或等于锁钉300的锁结筒302的内孔即穿线腔301的直径，且小于锁钉300的锁结筒302的外径，从而能使推杆42抵推第一外斜面2201远端时，第一夹头221与第二夹头223能够对锁钉300充分压型，以锁紧穿设于锁钉300内的缝合线。
请一并参阅图8及图9，第一夹头221变形前与变形回弹结束后的凸起部220的最高点之间的高度差值H小于锁钉300的初始高度h1与压瘪后高度h2的差值。具体地，第一夹头221变形前凸起部220的最高点与经销钉24轴心的轴向平面之间的垂直长度为H2(如图8所示)，第一夹头221受压回弹结束后凸起部220容置于推杆42的凹陷部420内，此时凸起部220的最高点与经销钉24轴心的轴向平面之间的垂直长度为H3(如图9所示)，H2减去H3即得到所述高度差值H，所述高度差值H小于锁钉300压型前的初始高度h1与锁钉300压瘪后高度h2的差值，以方便锁钉300顺利脱出夹头22的空隙25；当所述差值H为0时，第一夹头221完全恢复至初始状态。
第一外斜面2201与第二外斜面2203的相交处圆弧过渡，方便推杆42顺畅地越过第一外斜面2201与第二外斜面2203的相交处，即方便推杆42自第一外斜面2201平稳地滑至第二外斜面2203上。
第二夹头223面朝第一夹头221的侧面邻近远端处设置第二夹齿2235，第二夹齿2235包括若干齿槽，第二夹齿2235的每一齿槽的延伸方向与第一夹齿2215的齿槽的延伸方向相同。当第一夹头221与第二夹头223沿销钉24相互靠拢时，第一夹头221的第一夹齿2215与第二夹头223的第二夹齿2235错位并能相互啮合，因此，第一夹头221弹性变形朝第二夹头223靠拢，第一夹齿2215及第二夹齿2235将放置于空隙25内的锁钉300挤压成具有曲率的形状。第二夹头223背离第一夹头221的侧面的近端设置水平的导滑面2236，导滑面2236上开设连通空隙25的穿线孔2237，便于穿过锁钉300后的缝合线自穿线孔2237穿出。第二夹头223背离第一夹头221的侧面的远端凸设一定位块2233，定位块2233的近端面靠近穿线孔2237，定位块2233的近端面为切线面2238。
请一并参阅图4及图10-图11，推杆组件40还包括沿轴向活动穿装在套筒82内的基座44及固定连接于基座44一侧的切线刀片46，推杆42的近端固定连接在基座44上相对 切线刀片46的另一侧，推杆42沿轴向向远端延伸。所述连接部67转动连接基座44，且连接部67与基座44之间设有轴向限位结构。切线刀片46与推杆42间隔相对设置，切线刀片46沿轴向在导滑面2236上滑动。
凹陷部420设于推杆42贴近第一夹头221的一侧并靠近推杆42的远端。凹陷部420包括相交的第一内斜面4201及第二内斜面4203，第一内斜面4201较第二内斜面4203远离推杆42的远端面。当凸起部220容置于凹陷部420内时，第一外斜面2201与第一内斜面4201对应，第二外斜面2203与第二内斜面4203对应。
如图11所示，第一内斜面4201自其近端向远端逐渐向远离第一夹头221的一侧倾斜延伸，第二内斜面4203自其近端向远端逐渐向靠近第一夹头221的一侧倾斜延伸。第二外斜面4203的远端边缘圆弧过渡，以便推杆42平稳地滑动抵接第二外斜面2203；推杆42的远端面与推杆42的贴近夹头22的表面之间圆弧过渡，以便推杆42平稳地滑动抵接第一外斜面2201。
凹陷部420的第一内斜面4201与第二内斜面4203之间的夹角b大于或等于凸起部220的第一外斜面2201与第二外斜面2203之间的夹角a，以便于凸起部220容置于凹陷部420内。优选地，第一内斜面4201与垂直于轴向的竖直面O之间的第三夹角b1大于或等于所述第一夹角a1，第二内斜面4203与垂直于轴向的竖直面O之间的第四夹角b2大于或等于第二夹角a2；第三夹角b1与第四夹角b2之和等于第一内斜面4201与第二内斜面4203之间的夹角b。
如图11所示，凹陷部420的最大深度H4为凹陷部420的最高点至推杆42贴近夹头22的表面之间的垂直长度，所述最大深度H4大于或等于第一外斜面2201远端与近端的高度差值H1，或者说凸起部220的最大高度值，以保证凸起部220能够完全容置于凹陷部420内，为夹头22提供充足的回弹空间；当凸起部220容置于凹陷部420内时，空隙25的高度大于锁钉300被压瘪后的高度h2，以方便释放锁钉300。
切线刀片46的远端设置刀刃461，当凸起部220完全容置于凹陷部420时，刀刃461抵触切线面2238，以切断穿过穿线孔2237的缝合线。
可以理解的是，在其他实施例中，凸起部220的形状还可以是半球、圆台、圆锥等形状的凸起，凹陷部420的形状还可以是与凸起部220相适配的半球、圆台、圆锥等形状的凹槽或空缺。
请一并参阅图3、图4及图12-图14，柔性内芯63包括连接于螺纹传动件62近端的柔性内管64及插接于柔性内管64的内腔的芯杆66，连接部67连接于螺纹传动件62的远端与推杆组件40的基座44之间。柔性内管64缠绕在芯杆66上，柔性内管64与芯杆66共同构成柔性内芯63。螺纹传动件62包括传动丝杆621，传动丝杆621螺接于连接筒84的内螺纹。柔性内管64的远端固定连接于螺纹传动件62，柔性内管64的近端固定连接于驱动件70，驱动件70用于驱动柔性内芯63及螺纹传动件62转动。柔性内管64是具有一定支撑力的管体，优选螺旋结构或编织网结构等管体，可以采用不锈钢、镍钛合金、钴铬合金等材料制成。柔性内管64的外径小于柔性外管86的内径。柔性内管64相对于连接筒 84的旋转能够带动螺纹传动件62旋转并沿轴向移动。
芯杆66插接于柔性内管64的内腔，芯杆66为具有一定柔性的芯棒，优选的，芯杆66可以由不锈钢、镍钛合金、钴铬合金等材料制成。设置芯杆66能够方便在其上绕丝以形成柔性内管64，并增强所述柔性内芯63的扭控性。
传动丝杆621旋转并沿轴向移动以带动连接部67相对所述基座44转动，同时传动丝杆621的远端抵推所述基座44、推杆42及切线刀片46沿轴向朝远端移动。
在其他实施例中，连接部67也可以与推杆组件40固定连接，连接部67与螺纹传动件62转动连接，且连接部67与螺纹传动件62之间设置有防止连接部67相对于螺纹传动件62沿轴向移动的限位结构，使连接部67与螺纹传动件62旋转连接。
如图3及图13所示，驱动件70连接于传动组件60的近端，具体地，驱动件70是可转动地设置于手柄90的近端的旋转件，柔性内管64及芯杆66的近端固定连接于驱动件70。驱动件70的旋转带动柔性内管64及芯杆66一并旋转。驱动件70的外壁设置防滑机构79，手握防滑机构79方便转动驱动件70。
请一并参阅图2、图3及图15、图16，驱动件70转动连接于手柄90的近端，手柄90邻近驱动件70处沿轴向设置至少一长度刻度915，至少一长度刻度915用于显示驱动件70沿轴向移动的位移量。当驱动件70的远端面与长度刻度915上的0正对时，夹头22的第一夹头221与第二夹头223处于完全张开状态，推杆42没有对夹头22施加沿轴向的推力；当驱动件70旋转并沿轴向移动至其远端面与长度刻度915上的某一刻度值如“6”正对时，推杆42抵推至夹头22的凸起部220的最高点，第一夹头221与第二夹头223挤压锁钉300变形而固定穿设于锁钉300内的缝合线；当驱动件70继续同向旋转并沿轴向移动至其远端面与长度刻度915上的另一刻度值如“7.5”正对时，夹头22上的凸起部220容置于推杆42的凹陷部420内，夹头22的第一夹头221部分弹性复位而远离第二夹头223，便于锁钉300的释放。
请参阅图17至图23，以下以三尖瓣的瓣膜修复术为例，说明本申请提供的前推释放型缝合线锁结装置100的使用过程。
三尖瓣为右心房(简称：RA)和右心室(简称：RV)之间的单向“阀门”，可以保证血液从右心房流向右心室。正常健康的三尖瓣具有多根腱索。三尖瓣的瓣叶分为前叶、后叶和隔叶，右心室处于舒张状态时，三者处于张开状态，血液从右心房流向右心室；右心室处于收缩状态时，腱索被拉伸，保证瓣叶不会被血流冲到心房侧，前叶、后叶和隔叶闭合良好，从而保证血液从右心室经过肺动脉瓣(简称：PV)流向肺动脉。若三尖瓣出现病变，当右心室处于收缩状态时，三尖瓣不能像正常状态时恢复完全关闭状态，而是出现关闭不全现象，血流的冲力会进一步导致瓣叶脱入右心房，造成血液返流。针对三尖瓣返流，可采用介入方式向各个瓣叶植入缝合线，然后使用本申请中的锁结装置将各个瓣叶上的缝合线锁结在一起，以实施缘对缘修复，具体过程如下：
第一步：如图17所示，首先向患者的三尖瓣的前叶、后叶和隔叶分别植入一根或多根带有弹性垫片501的缝合线500，缝合线500与瓣叶之间的点接触被转变为弹性垫片501 与瓣叶之间的面接触，可有效降低瓣叶撕裂的风险；
第二步：如图17及图21所示，在患者体外把三个瓣叶上的多根缝合线500均穿入前推释放型缝合线锁结装置100的锁钉300的穿线腔301中，并将缝合线500近端依次穿过锁钉300的穿线腔301、第一夹头221与第二夹头223之间的空隙25及穿线孔2237，从套筒82的穿线槽820穿出；
第三步：借助调弯鞘管(图未示出)将前推释放型缝合线锁结装置100远端经股静脉推入心脏右心房，向三尖瓣的瓣叶移动靠近，同时拉动缝合线500，直至前推释放型缝合线锁结装置100远端在右心房内到达预定位置；
第四步：分别调节前、后以及隔叶三个瓣叶缝合线500的松紧度，同时通过超声确定三尖瓣返流最轻的状态，当到达该状态时，停止调节并保持三组缝合线500的松紧状态，即，保持三尖瓣的前叶、后叶和隔叶之间的相对位置；
第五步：如图18及图22所示，旋转手柄90上的驱动件70，螺纹传动件62在旋转同时沿轴向向远端移动，带动驱动件70、柔性内芯63及螺纹传动件62边旋转边沿轴向朝远端移动，螺纹传动件62抵推推杆组件40沿轴向朝远端移动，在推杆组件40沿轴向远端移动的过程中，推杆42相对夹头22向远端移动，推杆42的远端持续地抵推、挤压第一夹头221上的第一外斜面2201直至到达所述凸起部220的最高点，使得第一夹头221向第二夹头223靠拢，第一夹齿2215与第二夹齿2235压握容置于空隙25内的锁钉300，直至锁钉300变形，将锁钉300中的三组缝合线500锁结在一起。
第六步：如图19、图20及图23所示，沿相同的旋转方向继续旋转手柄90上的驱动件70，螺纹传动件62继续沿轴向向远端移动，驱动推杆42继续向远端移动，直至第一夹头221上的凸起部220进入推杆42的凹陷部420中，夹头22释放锁钉300，切线刀片46将缝合线500切断，锁钉300自夹头22的空隙25内解脱出来；然后将多余的缝合线500经锁结路径抽出患者体外；
第七步：将锁结装置100远端撤出患者体外，锁钉300留在患者体内，此时锁钉300将分别穿过前叶、后叶和隔叶的三组缝合线固定在一起，三尖瓣的前叶、后叶和隔叶完成修复。
可以理解的是，上述仅以前推释放型缝合线锁结装置用于进行介入式的三尖瓣修复过程为例，说明其使用过程，本申请的前推释放型缝合线锁结装置也可用于其他手术过程中对缝合线的锁紧及固定。
请参阅图25，本申请第二实施例提供的前推释放型缝合线锁结装置的结构与第一实施例的结构相似，不同之处在于：第二实施例中的推杆组件40a及螺纹传动件62a的结构与第一实施例的结构略有不同，且推杆组件40a与螺纹传动件62a的连接结构与第一实施例略有不同，具体如下：
第二实施例中的前推释放型缝合线锁结装置也包括夹头22、推杆组件40a、传动组件及外套组件80a，螺纹传动件62a转动连接于外套组件80a，螺纹传动件62a与推杆组件40a之间螺纹配合传动，螺纹传动件62a仅旋转，通过螺纹传动件62a与推杆组件40a之间的 螺纹传动将螺纹传动件62a的旋转转化为推杆42沿轴向的移动。
螺纹传动件62a包括位于远端的传动丝杆621及自传动丝杆621的近端沿轴向延伸的连接杆625，传动丝杆621的近端的外壁径向设置止挡环627。
第二实施例中的推杆组件40a的基座44a是在第一实施例中的推杆组件40的结构的基础上设置螺孔444，传动丝杆621与螺孔444螺接配合。
外套组件80a省略了第一实施例中的外套组件80的连接筒，在套筒82的内壁对应螺纹传动件62a设置环形的凸缘842，螺纹传动件62a的近端转动插设于凸缘842内，螺纹传动件62a的外周壁于凸缘842的远端设置止挡环627，螺纹传动件62a于凸缘842的近端固定连接一固定环68，止挡环627与固定环68围成旋转槽，凸缘842可转动地收容于所述旋转槽内，柔性外管86的远端固定连接套筒82的近端。由于止挡环627止挡于凸缘842的远端面，固定环68止挡于凸缘842的近端面，连接杆625及螺纹传动件62a仅能旋转，不能沿轴向移动。
本实施例中由于省略了连接筒84且螺纹传动件62a的传动丝杆621直接与推杆组件40a的基座44a通过螺纹配合传动，更节省空间。
第二实施例的前推释放型缝合线锁结装置的使用与第一实施例相似，不同之处在于，旋转手柄上的驱动件，驱动件的旋转带动柔性内芯及螺纹传动件62原位旋转，基座44a带动推杆42相对夹头22向远端移动。
需要说明的是，在不脱离本申请实施例原理的前提下，以上各个实施例中的具体技术方案可以相互适用，在这里不做赘述。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (18)

  1. 一种前推释放型缝合线锁结装置，用于将缝合线固定在锁钉中，其特征在于，包括夹头及套设于所述夹头外的推杆组件；所述锁钉容置在所述夹头的远端，所述夹头自身具有弹性；所述推杆组件包括推杆，所述推杆面朝所述夹头的一侧设有凹陷部，所述夹头面朝所述推杆的一侧设置对应所述凹陷部的凸起部；在所述推杆沿轴向持续朝远端移动的过程中，所述推杆先抵推所述凸起部逐渐升高的一侧，以迫使所述夹头压迫锁钉变形而锁紧所述缝合线；之后所述凸起部逐渐容置于所述凹陷部内，使得所述夹头至少恢复部分形变，以释放所述锁钉。
  2. 根据权利要求1所述的前推释放型缝合线锁结装置，其特征在于，所述凸起部包括第一外斜面及与所述第一外斜面相交的第二外斜面；所述第一外斜面自其近端向远端逐渐升高，所述第二外斜面自其近端向远端逐渐降低。
  3. 根据权利要求2所述的前推释放型缝合线锁结装置，其特征在于，所述凸起部的所述第一外斜面与所述第二外斜面之间夹角的角度范围大于等于120度且小于180度。
  4. 根据权利要求3所述的前推释放型缝合线锁结装置，其特征在于，所述第一外斜面的斜度小于所述第二外斜面的斜度；所述夹头处于自然状态时，所述第一外斜面与垂直于轴向的竖直面之间的第一夹角的角度范围大于等于70度且小于90度，所述第二外斜面与垂直于轴向的竖直面之间的第二夹角的角度范围大于等于50度且小于90度。
  5. 根据权利要求2所述的前推释放型缝合线锁结装置，其特征在于，所述第一外斜面的远端与近端的高度差值大于或等于所述锁钉的内孔直径，且小于所述锁钉的外径。
  6. 根据权利要求2所述的前推释放型缝合线锁结装置，其特征在于，所述第一外斜面与所述第二外斜面之间圆滑过渡；所述推杆的远端面与所述推杆的贴近所述夹头的表面之间圆滑过渡。
  7. 根据权利要求2所述的前推释放型缝合线锁结装置，其特征在于，所述凹陷部设于所述推杆的远端，所述凹陷部包括第一内斜面及与所述第一内斜面相交的第二内斜面；当所述凸起部容置于所述凹陷部内时，所述第一外斜面与所述第一内斜面对应，所述第二外斜面与所述第二内斜面对应。
  8. 根据权利要求7所述的前推释放型缝合线锁结装置，其特征在于，所述凹陷部的第一内斜面与第二内斜面之间的夹角大于或等于所述凸起部的第一外斜面与第二外斜面之间的夹角。
  9. 根据权利要求8所述的前推释放型缝合线锁结装置，其特征在于，所述第一内斜面与垂直于轴向的竖直面之间的夹角大于或等于所述夹头处于自然状态时所述第一外斜面与垂直于轴向的竖直面之间的夹角；所述第二内斜面与垂直于轴向的竖直面之间的夹角大于或等于所述夹头处于自然状态时所述第二外斜面与垂直于轴向的竖直面之间的夹角。
  10. 根据权利要求7所述的前推释放型缝合线锁结装置，其特征在于，所述凹陷部的最大深度大于或等于所述凸起部的最大高度。
  11. 根据权利要求7所述的前推释放型缝合线锁结装置，其特征在于，所述第二内斜面 与所述推杆的贴近所述夹头的表面之间圆滑过渡。
  12. 根据权利要求1所述的前推释放型缝合线锁结装置，其特征在于，还包括连接于所述推杆组件的传动组件，所述传动组件包括螺纹传动件及固定连接所述螺纹传动件的柔性内芯，所述螺纹传动件转动连接所述推杆组件；所述柔性内芯的旋转带动所述螺纹传动件旋转，所述螺纹传动件驱动所述推杆沿轴向移动。
  13. 根据权利要求12所述的前推释放型缝合线锁结装置，其特征在于，还包括围设于所述夹头、所述推杆组件及所述传动组件外的外套组件；所述外套组件包括套筒及固定连接所述套筒的柔性外管，所述套筒内容置所述夹头及所述推杆组件，所述夹头固定连接所述套筒，所述柔性外管套设于所述柔性内芯外。
  14. 根据权利要求13所述的前推释放型缝合线锁结装置，其特征在于，所述螺纹传动件为传动丝杆；所述螺纹传动件的远端通过一连接件转动连接所述推杆组件，所述螺纹传动件同步旋转及轴向移动以驱使所述推杆沿轴向移动。
  15. 根据权利要求13所述的前推释放型缝合线锁结装置，其特征在于，所述螺纹传动件为传动丝杆；所述螺纹传动件直接螺接所述推杆组件，所述螺纹传动件仅旋转以驱使所述推杆沿轴向移动。
  16. 根据权利要求12至15任一项所述的前推释放型缝合线锁结装置，其特征在于，还包括驱动所述柔性内芯及所述螺纹传动件转动的驱动件，所述驱动件固定连接于所述柔性内芯的近端。
  17. 根据权利要求16所述的前推释放型缝合线锁结装置，其特征在于，还包括手柄，所述驱动件可转动地设置于所述手柄的近端。
  18. 根据权利要求12所述的前推释放型缝合线锁结装置，其特征在于，所述推杆组件还包括设置于所述推杆的对侧的切线刀片。
PCT/CN2021/081591 2020-03-20 2021-03-18 前推释放型缝合线锁结装置 WO2021185323A1 (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP21771267.8A EP4122403A4 (en) 2020-03-20 2021-03-18 PUSH FORWARD RELEASE TYPE SUTURE LINE LOCKING DEVICE
US17/948,402 US20230025774A1 (en) 2020-03-20 2022-09-20 Forward-pushing for releasing suture locking device

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202020370900.6 2020-03-20
CN202010205925.5A CN113491547A (zh) 2020-03-20 2020-03-20 前推释放型缝合线锁结装置
CN202020370900.6U CN212490016U (zh) 2020-03-20 2020-03-20 前推释放型缝合线锁结装置
CN202010205925.5 2020-03-20

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US17/948,402 Continuation US20230025774A1 (en) 2020-03-20 2022-09-20 Forward-pushing for releasing suture locking device

Publications (1)

Publication Number Publication Date
WO2021185323A1 true WO2021185323A1 (zh) 2021-09-23

Family

ID=77771909

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/081591 WO2021185323A1 (zh) 2020-03-20 2021-03-18 前推释放型缝合线锁结装置

Country Status (3)

Country Link
US (1) US20230025774A1 (zh)
EP (1) EP4122403A4 (zh)
WO (1) WO2021185323A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113925548A (zh) * 2021-11-26 2022-01-14 上海以心医疗器械有限公司 一种剪线装置及剪线器

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7235086B2 (en) * 2001-02-02 2007-06-26 Lsi Solutions, Inc. Crimping instrument with motion limiting feature
US20110251641A1 (en) * 2010-04-07 2011-10-13 Lsi Solutions, Inc. Bioabsorbable magnesium knots for securing surgical suture
CN105916452A (zh) * 2013-11-18 2016-08-31 爱德华兹生命科学股份公司 多次击发压接装置
CN106073836A (zh) * 2016-06-01 2016-11-09 北京迈迪顶峰医疗科技有限公司 一种打结器及具有该打结器的打结***
CN107920814A (zh) * 2015-08-04 2018-04-17 奥林巴斯株式会社 缝合装置
US20180256159A1 (en) * 2014-07-08 2018-09-13 Lsi Solutions, Inc. Rotation adapter and receiver for minimally invasive surgical devices
CN209107426U (zh) * 2018-06-08 2019-07-16 杭州德晋医疗科技有限公司 可调节的心脏瓣膜修复***
CN209186798U (zh) * 2018-06-08 2019-08-02 杭州德晋医疗科技有限公司 可调节的缝合线锁结装置
CN212490016U (zh) * 2020-03-20 2021-02-09 杭州德晋医疗科技有限公司 前推释放型缝合线锁结装置
CN212630823U (zh) * 2020-07-06 2021-03-02 杭州德晋医疗科技有限公司 可调弯的缝合线锁结装置

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7235086B2 (en) * 2001-02-02 2007-06-26 Lsi Solutions, Inc. Crimping instrument with motion limiting feature
US20110251641A1 (en) * 2010-04-07 2011-10-13 Lsi Solutions, Inc. Bioabsorbable magnesium knots for securing surgical suture
CN105916452A (zh) * 2013-11-18 2016-08-31 爱德华兹生命科学股份公司 多次击发压接装置
US20180256159A1 (en) * 2014-07-08 2018-09-13 Lsi Solutions, Inc. Rotation adapter and receiver for minimally invasive surgical devices
CN107920814A (zh) * 2015-08-04 2018-04-17 奥林巴斯株式会社 缝合装置
CN106073836A (zh) * 2016-06-01 2016-11-09 北京迈迪顶峰医疗科技有限公司 一种打结器及具有该打结器的打结***
CN209107426U (zh) * 2018-06-08 2019-07-16 杭州德晋医疗科技有限公司 可调节的心脏瓣膜修复***
CN209186798U (zh) * 2018-06-08 2019-08-02 杭州德晋医疗科技有限公司 可调节的缝合线锁结装置
CN212490016U (zh) * 2020-03-20 2021-02-09 杭州德晋医疗科技有限公司 前推释放型缝合线锁结装置
CN212630823U (zh) * 2020-07-06 2021-03-02 杭州德晋医疗科技有限公司 可调弯的缝合线锁结装置

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113925548A (zh) * 2021-11-26 2022-01-14 上海以心医疗器械有限公司 一种剪线装置及剪线器
CN113925548B (zh) * 2021-11-26 2024-07-19 上海以心医疗器械有限公司 一种剪线装置及剪线器

Also Published As

Publication number Publication date
EP4122403A1 (en) 2023-01-25
EP4122403A4 (en) 2023-08-16
US20230025774A1 (en) 2023-01-26

Similar Documents

Publication Publication Date Title
US20220142781A1 (en) Valve clamping system capable of being independently controlled
CN212630823U (zh) 可调弯的缝合线锁结装置
CN109498216A (zh) 一种用于瓣膜修复的牵拉线锁定导管
US20230320851A1 (en) Valve clip delivery device
WO2021185323A1 (zh) 前推释放型缝合线锁结装置
US20220125427A1 (en) Locking nail for locking sutures and interventional remote suture locking device
CN113491547A (zh) 前推释放型缝合线锁结装置
CN110313951B (zh) 缝合线锁扣及缝合线锁结***
CN211934163U (zh) 介入式锁结装置
WO2022068202A1 (zh) 医用锁扣及医用锁结装置
CN113892986A (zh) 可调弯的缝合线锁结装置
CN114305551A (zh) 医用锁扣及医用锁结装置
CN212490016U (zh) 前推释放型缝合线锁结装置
CN212346607U (zh) 直驱式缝合线锁结装置
CN110575210A (zh) 可调节的缝合线锁结装置
CN112206022B (zh) 介入式远程锁结及切线装置
CN211723286U (zh) 介入式远程锁结及切线装置
US20210315565A1 (en) Locking device with locking feedback function and heart valve repair system
CN211243518U (zh) 介入式远程缝合线锁结装置
CN113040843A (zh) 拉力驱动式锁结装置
US11986180B2 (en) Adjustable suture locking apparatus
CN215839709U (zh) 心脏瓣膜修复装置
CN211934162U (zh) 驱动转换型锁结装置
CN113040844A (zh) 介入式锁结装置
WO2021129058A1 (zh) 介入式锁结装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21771267

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2021771267

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 2021771267

Country of ref document: EP

Effective date: 20221020

NENP Non-entry into the national phase

Ref country code: DE