WO2020134060A1 - 具有锁紧反馈的锁紧装置及心脏瓣膜修复系统 - Google Patents

具有锁紧反馈的锁紧装置及心脏瓣膜修复系统 Download PDF

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Publication number
WO2020134060A1
WO2020134060A1 PCT/CN2019/097747 CN2019097747W WO2020134060A1 WO 2020134060 A1 WO2020134060 A1 WO 2020134060A1 CN 2019097747 W CN2019097747 W CN 2019097747W WO 2020134060 A1 WO2020134060 A1 WO 2020134060A1
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WO
WIPO (PCT)
Prior art keywords
locking
feedback
suture
locking device
notch
Prior art date
Application number
PCT/CN2019/097747
Other languages
English (en)
French (fr)
Inventor
张庭超
郑贤章
张伟伟
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 CN201822205997.0U external-priority patent/CN209966454U/zh
Priority claimed from CN201811599592.8A external-priority patent/CN111358509A/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 EP19906284.5A priority Critical patent/EP3903687A4/en
Publication of WO2020134060A1 publication Critical patent/WO2020134060A1/zh
Priority to US17/357,709 priority patent/US20210315565A1/en

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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
    • A61B17/0482—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
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • 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
    • A61B2017/00982—General structural features
    • A61B2017/00991—Telescopic means
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • 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
    • A61F2/2463—Implants forming part of the valve leaflets

Definitions

  • the invention relates to the field of medical instruments, and in particular to a locking device with locking feedback and a heart valve repair system.
  • the operation step of knotting and fixing the suture is often required.
  • the traditional surgical operation is performed under the condition of direct vision, and it can usually be knotted manually by a doctor.
  • various minimally invasive surgery and interventional surgery are becoming more common, such as endoscopic surgery and transcatheter interventional surgery.
  • Such surgery only requires a small operating window to be cut on the patient's body, which will Instruments such as endoscopes or interventional catheters extend into the patient's body and reach a predetermined location for treatment.
  • the operator usually needs to perform a remote operation outside the patient's body through a small operating window to knot the suture in the patient's body.
  • surgical robots, thread knot pushers, or transcatheter suture lock implant systems are often used to knot or fix the suture at a distance.
  • PTFE sutures are usually made of PET or PTFE.
  • PTFE sutures are usually single strands, and PTFE itself is a polymer material.
  • metal parts such as locks and lock nails.
  • the compression point is prone to pressure injury or breakage, which causes the suture to be broken in the implant for a short period of time or easy to fatigue and break after long-term use; and if the operator does not apply enough force when locking, the metal piece does not connect the suture Locking will cause slippage again.
  • the prior art US7235086B2 discloses a locking device for sutures.
  • the suture thread is fixed in the lumen of the locking nail through a locking nail with a hollow cavity and a locking device matched with the locking nail.
  • the locking device of the structure is used to lock the suture, it cannot effectively judge whether the suture is locked or excessively locked.
  • the present invention provides a locking device with locking feedback.
  • you can judge whether it is locked by the feedback of the lock to ensure the locking strength of the suture, which can prevent the suture from being locked and from being excessively locked
  • the wire breakage failure occurs due to pressure injury, thereby ensuring the locking effect and improving the success rate of surgery.
  • a locking assembly the locking assembly is used to lock the target object
  • a handle the locking assembly is connected to the handle, the handle includes a movable portion and a fixed portion, the movable portion moves relative to the fixed portion to drive the locking assembly to lock the target object;
  • a locking feedback member which is movably arranged in the fixing portion, and cooperates with the movable portion of the handle to feedback whether the target object is locked.
  • the present invention also provides a heart valve repair system, the heart valve repair system includes the locking device according to any one of the above, and further includes at least one suture, the suture is used for implantation in the heart valve On the leaf.
  • the present invention has at least the following beneficial effects:
  • the locking feedback member can be used to judge whether the target object is locked
  • the locking of the tightening component can ensure the locking degree of the target object, thereby ensuring the locking effect and improving the success rate of the operation.
  • the heart valve repair system provided by the present invention first implants a suture thread on one or different leaflets of the heart valve, and then fixes the suture thread on the apex, papillary muscle, or ventricular wall through the locking device, or multiple pieces through the locking device
  • the suture thread is fixed together, and during the locking process, the locking feedback member can be used to determine whether the suture thread is locked to ensure the locking degree of the suture thread, thereby ensuring the locking effect and improving the success rate of surgery; and It can prevent the suture from being crushed or broken due to excessive locking, and prevent the suture from breaking.
  • FIG. 1 is a schematic structural diagram of a locking device with locking feedback provided by a first embodiment of the present invention
  • FIG. 2 is an internal cross-sectional view of a locking device with locking feedback according to the first embodiment
  • FIG. 3 is an exploded schematic view of the three-dimensional structure of the locking feedback member and the fixing portion of the first embodiment
  • FIG. 4 is a rear view of the locking feedback member in FIG. 3;
  • FIG. 5a is a left side view of the locking feedback member in FIG. 3;
  • 5b is a cross-sectional view taken along line A-A in FIG. 5a;
  • FIG. 6 is a partially enlarged view of part M in FIG. 3;
  • FIG. 7 is a partial enlarged view of part N in FIG. 2;
  • FIG. 8 is a schematic structural diagram of a locking feedback member in a locking device with locking feedback according to a second embodiment of the present invention.
  • FIG. 9 is a rear view of FIG. 8;
  • FIG. 10a is a left side view of FIG. 8;
  • 10b is a cross-sectional view taken along line A-A in FIG. 10a;
  • FIG. 11 is a schematic view of the state of the locking feedback member in the second embodiment after the locking device is locked;
  • 12a is a schematic diagram of the initial state of the locking feedback member in the fixing portion in the second embodiment
  • FIG. 12b is a partially enlarged view of part S in FIG. 12a;
  • 12c is a schematic view of the state of the locking feedback member in the second embodiment after locking feedback in the fixed portion;
  • FIG. 12d is a partially enlarged view of the T part in FIG. 12c;
  • FIG. 13a and 13b are schematic structural views of a movable part in a locking device with locking feedback provided by a third embodiment of the present invention.
  • FIG. 14 is a schematic structural diagram of a locking device with locking feedback according to a fourth embodiment of the present invention.
  • FIG. 15 is a partial enlarged view of the R part in FIG. 14;
  • 16a is a schematic diagram of the locking device in FIG. 1 before locking feedback
  • 16b is a schematic diagram of the internal structure of the locking device in FIG. 16a;
  • 17a is a schematic diagram of the locking device in FIG. 1 after locking feedback
  • FIG. 17b is a schematic diagram of the internal structure of FIG. 17a;
  • FIG. 18 is a partial enlarged view of the W portion in FIG. 17b;
  • FIG. 19 is an exploded schematic view of a locking assembly in a locking device provided by the present invention.
  • 20a and 20b are schematic views of the locking nail provided by the present invention before and after fixing the suture
  • 21a to 21c are schematic structural views of the handle part in FIG. 19;
  • 22a and 22b are schematic structural diagrams of a wire harness in a locking assembly provided by the present invention.
  • FIG. 23 is a schematic structural view of the suture fixing portion in FIG. 22;
  • FIG. 25a is a schematic structural diagram of a handle part in a locking device according to a fifth embodiment of the present invention, and FIG. 25b is a B-B cross-sectional view of FIG. 25a;
  • Figure 26 is a partial enlarged view of the part of Figure 25b;
  • FIG. 27 is an exploded view of a locking device provided by a sixth embodiment of the present invention.
  • FIG. 28 is a schematic structural view of one of the adjusting devices in FIG. 27;
  • 29 is a schematic structural view of the locking nail provided by the present invention.
  • FIG. 30 is a schematic structural diagram of another form of the locking nail provided by the present invention.
  • FIG. 31 is a schematic structural diagram of a crimping assembly provided by the present invention.
  • 32a and 32b are schematic diagrams of pressing and holding a locking nail in a locking device provided by the present invention.
  • Figures 33a and 33b are partially enlarged views of Figure 32b at C;
  • 34a and 34b are schematic structural views of a holding portion in a locking device provided by the present invention.
  • FIG. 35 to 38 are schematic diagrams of a process of using a locking device according to a sixth embodiment of the present invention for mitral valve repair, wherein FIG. 35 is a schematic diagram of implanting sutures into the anterior and posterior lobes of the valve leaflets, respectively; 36 is a schematic diagram of threading the suture into the locking device; FIG. 37 is a schematic diagram of adjusting the length of the suture thread and pressing the locking nail provided by the locking device; FIG. 38 is a method of passing the proximal end of the suture thread provided by the present invention Schematic diagram of the locking nail fixed on the wall of the ventricle;
  • 39 is a schematic structural diagram of a heart valve repair system provided by the present invention.
  • orientation near the operator is defined as the near end
  • orientation away from the operator is defined as the far end.
  • all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the technical field of the present invention.
  • the conventional terms used in the description of the present invention are only for the purpose of describing specific embodiments, and cannot be construed as limiting the present invention.
  • the present invention provides a locking device 100 with locking feedback.
  • the locking device 100 includes a locking assembly 200, a handle 3000, and a locking feedback member 8000.
  • the locking assembly 200 is used to lock the target object 300 (see FIG. 2 ).
  • the locking assembly 200 is connected to the handle 3000.
  • the handle 3000 includes a fixed portion 3100 and a movable portion 3200.
  • the movable portion 3200 can move relative to the fixed portion 3100 to drive the locking
  • the assembly 200 locks the target object 300 (see FIGS. 16a to 17b).
  • the locking feedback member 8000 is movably disposed in the fixed portion 3100, and cooperates with the movable portion 3200 of the handle 3000 to feedback whether the target object 300 is locked.
  • the movable part 3200 and the fixed part 3100 of the handle 3000 move relative to each other, thereby driving the locking assembly 200 to lock the target object 300. Therefore, when the operator operates the movable part 3200 and the fixed part 3100, the locking feedback member 8000 acts at the same time to lock The feedback effect of the feedback member 8000 is synchronized with the operation of the handle 3000, so that the locking degree of the locking object 200 to the target object 300 can be accurately fed back.
  • the locking device 100 with locking feedback provided by the present invention when used to lock the target object 300, can determine whether the target object 300 is locked by the locking assembly 200 through the locking feedback member 8000, and can guarantee the target object 300 The degree of locking, so as to ensure the locking effect and improve the success rate of surgery.
  • the locking feedback member 8000 generates a sound by being exposed to the fixing portion 3100 or colliding with the fixing portion 3100 to feedback whether the target object 300 is locked.
  • the locking feedback member 8000 collides with the fixed portion 3100 to emit a sound to remind the operator that the target object 300 has reached the target locking degree, and the locking operation is completed at this time.
  • the feedback member 8000 collides with the sound of the fixed part 3100 to feedback, which not only makes the judgment more timely, but also allows the operator to know the locked state without looking down at the locking device 100, which is more conducive to the operator to observe medical equipment such as ultrasound equipment in real time during the operation Imaging device.
  • the portion where the locking feedback member 8000 strikes the fixing portion 3100 is made of a harder material, so that a crisp impact sound can be generated during the collision.
  • the locking feedback member 8000 includes a feedback slider 8100, a support member 8200, and an elastic member 8300 connected between the feedback slider 8100 and the support member 8200 (see FIG. 6) ).
  • the feedback slider 8100 moves toward the proximal end of the fixed portion 3100 under the action of the movable portion 3200, and the support 8200 follows the feedback slider 8100.
  • the fixing portion 3100 is provided with a first notch 3110. When the support 8200 moves to the first notch 3110 and falls into the first notch 3110, the locking feedback member 8000 is exposed to the fixing portion 3100 or collides with the fixing portion 3100 to generate sound To feedback that the target object 300 is locked.
  • the elastic member 8300 is used to restore the natural state when the support member 8200 moves to the first slot 3110, so that the support member 8200 falls into the first slot 3110 (see FIG. 6). It can be understood that, when the support member 8200 does not reach the first notch 3110, the elastic member 8300 is in a compressed state. It can be understood that the first notch 3110 may be provided on the surface of the housing of the fixing portion 3100.
  • the fixing portion 3100 is provided with a first limiting groove 3120 and a second limiting groove 3130.
  • the fixed portion 3100 includes a mounting frame 3300 (see FIG. 7) protruding toward the movable portion 3200.
  • the mounting frame 3300 includes an extension plate 3310 and a flange 3320 provided at the edge of the extension plate 3310.
  • the extension plate 3310 is spaced in parallel
  • a first limiting groove 3120 and a second limiting groove 3130 are provided.
  • the first limiting groove 3120 and the second limiting groove 3130 both extend from the distal end to the proximal end.
  • the feedback slider 8100 can move toward the proximal end of the fixed portion 3100 in the first limiting groove 3120 under the action of the movable portion 3200.
  • the supporting member 8200 can move in the same direction as the feedback slider 8100 in the second limit slot 3130, and a first slot 3110 is provided on the edge adjacent to the second limit slot 3130.
  • the first slot 3110 and the second limit slot The slot 3130 communicates.
  • the first slot 3110 is disposed adjacent to the proximal end of the fixing portion 3100 and penetrates the outer surface in the direction D of the bottom end of the fixing portion 3100.
  • the bottom end D of the fixing portion 3100 refers to the end in the vertical direction where the proximal end of the locking device 100 points to the distal direction. That is, in this embodiment, when the locking feedback member 8000 is under the action of the movable portion 3200, it moves from the distal end to the proximal end of the fixing portion 3100 in the fixing portion 3100, and when the support member 8200 moves to the first groove When in the opening 3110, the support 8200 falls into the first notch 3110 toward the bottom end D of the fixing portion 3100. It can be understood that the length of the support 8200 can be set so that when the support 8200 falls into the first notch 3110, it protrudes from the outer surface of the bottom end D of the fixing portion 3100 from the first notch 3110. When the user sees the part of the support 8200 extending from the first slot 3110, the operator is prompted to lock the target device 300 by the locking device 100.
  • the locking feedback member 8000 further includes an impact member 8400, the elastic member 8300 elastically pushes against the impact member 8400, and the support member 8200 is disposed on a side of the impact member 8400 facing away from the elastic member 8300; when the support member 8200 is directly opposite During the first notch 3110, the elastic member 8300 pushes the striking member 8400 to hit the fixed portion 3100 to make a sound to feedback that the target object 300 has been locked, and the support member 8200 falls into the first notch 3110.
  • the support member 8200 and the striking member 8400 can be connected by a snap, a screw, or an adhesive, or can be integrally formed.
  • the impact member 8400 When the support member 8200 falls into the first notch 3110, the impact member 8400 is pressed against the bottom end D of the fixing portion 3100 by the elastic member 8300. Since the impact member 8400 is disposed above the support member 8200, the support member 8200 is located at the elastic member When the action of 8300 falls into the first notch 3110, the elastic member 8300 also exerts a force on the striker 8400, so that the striker 8400 strikes the upper surface of the bottom end D of the fixing portion 3100 and is positioned in the fixing portion 3100. When the striking part 8400 and the fixed part 3100 collide with the hard material, a sound will occur at this time, and the operator will be alerted by the impact sound to lock the target object 300. It can be understood that the striker 8400 can be set to be locked at a corresponding position according to the structure of the fixing portion 3100, that is, the position of the striker 8400 to be locked can be various.
  • the cross-sectional area of the striker 8400 is larger than the cross-sectional area of the first slot 3110, so that when the support 8200 falls into the first slot 3110, the striker 8400 can bear against the first Above the notch 3110.
  • the second limiting groove 3130 includes a first support surface 3131, the support member 8200 slides on the first support surface 3131, and the first slot 3110 penetrates the first support surface 3131.
  • the first notch 3110 is provided adjacent to the proximal end of the fixing portion 3100.
  • the striker 8400 When the support 8200 falls into the first notch 3110, the striker 8400 is positioned on the first support surface 3131 around the first notch 3110.
  • the first supporting surface 3113 is a supporting surface located in the distal direction of the first notch 3110.
  • the striking member 8400 will make a sound when struck by the elastic member 8300 on the first supporting surface 3131.
  • the impact member 8400 includes an impact surface 8410 (see FIG. 6 ).
  • the impact surface 8410 is a side of the impact member 8400 that faces away from the elastic member 8300.
  • the impact surface 8410 is used to impact with the fixed portion 3100. In this embodiment, the impact The surface 8410 is used to collide with the first support surface 3131.
  • the second limiting groove 3130 further includes a second support surface 3132.
  • the second support surface 3132 and the first support surface 3131 are disposed on both sides of the first slot 3110, and the second support surface 3132 is The first supporting surface 3131 is on the same horizontal plane.
  • the striker 8400 strikes the first support surface 3131 and the second support surface 3132 at the same time. Two support surfaces are used to support the striker 8400, which increases the size of the sound during impact, while further avoiding the striker 8400 from the first The notch 3110 falls off.
  • the second limiting groove 3130 may further include a third support surface 3133 (see FIG. 6 ).
  • the third support surface 3133 is disposed between the first support surface 3131 and the second support surface 3132.
  • the third support surface 3133 The three support surfaces of the first support surface 3131 and the second support surface 3132 are used to collide with the impact surface 8410 in the impact member 8400 to make the impact sound louder.
  • the locking feedback member 8000 further includes a feedback button 8600 (see FIG. 4 or FIG. 9).
  • the feedback button 8600 includes a button portion 8610 and a second connection portion 8620.
  • the button portion 8610 is connected through the second connection portion 8620
  • the striker 8400 and the button portion 8610 are exposed on the outer surface of the bottom end D of the fixing portion 3100 (see FIGS. 6 and 7 ).
  • the impact member 8400 moves to the bottom of the fixing portion 3100 under the action of the elastic member 8300, and simultaneously drives the button portion 8610 on the feedback button 8600 to move, because the button portion 8610 is exposed to the fixing portion
  • the outer surface of the bottom end D of the 3100 the operator can judge whether the target object 300 is locked by observing the relative position distance between the button portion 8610 and the bottom end D of the fixing portion 3100, and feedback the locked state.
  • the button portion 8610 may be arranged in a more vivid color or in a shape that is easy to observe.
  • the locking state can also be fed back through the ringing sound.
  • the fixing portion 3100 further includes a second notch 3140.
  • the second notch 3140 extends along the second limiting groove 3130 and penetrates the second limiting groove 3130 and the fixing portion 3100 The outer surface of the bottom end D.
  • the second connecting portion 8620 passes through the second notch 3140.
  • the second connecting portion 8620 moves in the second notch 3140 to drive the exposure to the fixed portion 3100
  • the button 8610 at the bottom D moves.
  • the size of the second notch 3140 matches the second connecting portion 8620.
  • the second notch 3140 can also be opened on the side of the fixing portion 3100.
  • the distance between the button portion 8610 and the fixing portion 3100 away from the outer surface of the second limiting groove 3130 is less than the preset distance. That is to say, the distance between the button portion 8610 and the bottom D surface of the fixing portion 3100 is less than a preset distance.
  • the preset distance is zero, that is, the button portion 8610 is in contact with the bottom D surface of the fixing portion 3100.
  • the feedback button 8600 is also used to press the feedback slider 8100 until the support member 8200 is located in the second limit slot 3130, and then to the fixed portion
  • the distal end of 3100 advances to reset the feedback button 8600, the support 8200, and the feedback slider 8100.
  • the locking feedback member 8000 can be used again to feedback whether the target object 300 is locked.
  • the locking device 100 can be used repeatedly during operation.
  • the surface of the button portion 8610 facing away from the second connecting portion 8620 is provided with a tooth pattern 8611 (see FIG. 4) or a protrusion.
  • the toothed portion 8611 or the protruding portion provided on the button portion 8610 can increase the friction between the operator and the button portion 8610, making it faster and more convenient when the feedback button 8600 is operated to reset the support 8200 and the feedback slider 8100.
  • the fixed portion 3100 further includes a third notch 3150.
  • the opening direction of the third notch 3150 is consistent with the moving direction of the feedback slider 8100, and the movable portion 3200 passes the The three notches 3150 push the feedback slider 8100 to move.
  • the opening size of the third notch 3150 can be set according to actual conditions.
  • the movable portion 3200 is provided with a boss 3160 (see FIG. 7) corresponding to the position of the third notch 3150; when the movable portion 3200 moves toward the fixed portion 3100, the boss 3160 abuts the feedback slider 8100 And push the feedback slider 8100 to move in the first limit slot 3120.
  • the boss 3160 is used to apply a force point to the feedback slider 8100, which can push the feedback slider 8100 more effectively.
  • the elastic member 8300 includes one of a spring, a shrapnel, or a bouncy ball.
  • FIG. 4 and FIG. 9 a schematic diagram of the elastic member 8300 using a spring is shown.
  • the first embodiment is taken as an example to illustrate the working process of the present invention.
  • the locking assembly 200 uses the collet 6100 (see FIGS. 33 a and 33 b) to clamp the target object 300.
  • the target object 300 is a locking pin 1000 and is worn on the locking pin 1000. Multiple sutures in 5000.
  • FIG. 16a, FIG. 16b, FIG. 6 and FIG. 7 when the locking assembly 200 is not locking the target object 300, the movable part 3200 and the fixing part 3100 of the handle 3000 are in a separated state, and the feedback member 8000 is locked at this time
  • the supporting member 8200 is located in the second limiting groove 3130, and the elastic member 8300 is in a compressed state (see FIGS. 6 and 7).
  • the second embodiment of the present invention provides a locking device 100a with locking feedback.
  • the locking feedback member 8000 further includes at least one reverse buckle 8500.
  • the reverse buckle 8500 The first connecting portion 8510 and the locking portion 8520 are included.
  • the locking portion 8520 is connected to the feedback slider 8100 through the first connecting portion 8510.
  • the orthographic projection of the striker 8400 and the locking portion 8520 on the feedback slider 8100 is at least partially When the support member 8200 falls into the first notch 3110, the impact member 8400 abuts against the locking portion 8520 (see FIG. 11).
  • the elastic member 8300 simultaneously acts on the impact member 8400 to hit the locking portion 8520 to make a sound, that is, the impact surface 8410 of the impact member 8400 hits the locking position Part 8520 (see Figure 12d).
  • the orthographic projection of the striker 8400 and the locking portion 8520 on the feedback slider 8100 at least partially overlaps to ensure that the striker 8400 is stuck on the locking portion 8520.
  • the striker 8400 there are two reverse snaps 8500, and they are provided on opposite sides of the striker 8400. When the support falls into the first notch 3110, the striker 8400 abuts against the cards of the two reverse snaps 8500 Bit on the 8520. In some other embodiments, the number of reversals 8500 may be more than one.
  • a third embodiment of the present invention provides a locking device with locking feedback.
  • the boss 3160 includes a first coupling portion 3161 and a second coupling portion 3162, and the first coupling portion 3161 and the second coupling portion 3162 relatively expand and contract to adjust the axial length of the boss 3160.
  • the boss 3160 adjusts the length of the axis through the first coupling portion 3161 and the second coupling portion 3162, so that different locking force effects can be fed back.
  • the target object 300 is a lock nail 1000 and a suture 5000
  • the size of the locking force is adjusted separately. For example: when the number of sutures 5000 inside the lock nail 1000 increases or the wall thickness of the lock nail 1000 increases, only a small amount of force is required to make the collet 6100 (see FIGS. 33a and 33b) press the lock nail 1000 to the lock The nail 1000 is deformed.
  • the second joint 3162 can be adjusted to increase the overall axial length of the boss 3160 and shorten the stroke when the locking feedback state is reached.
  • the manner in which the first coupling portion 3161 and the second coupling portion 3162 relatively expand and contract includes thread expansion and contraction or snap expansion and contraction.
  • the first coupling portion 3161 and the second coupling portion 3162 are one of a screw member and a screw cap, respectively, and the screw cap is adapted to the screw member.
  • the first coupling part 3161 uses a screw
  • the second coupling part 3162 uses a screw cap.
  • the screw is arranged on the movable part 3200, and the boss 3160 is adjusted by the relative rotation of the screw cap and the screw The axial length.
  • the screw cap can also be provided on the movable portion 3200, and the axial length of the boss 3160 can be adjusted by relative rotation of the screw.
  • the fourth embodiment of the present invention provides a locking device 100c with locking feedback.
  • the locking device 100c when the supporting member 8200 is located in the second limiting groove 3130, the feedback slider 8100 protrudes from the third notch 3150 to the outer surface of the fixing portion 3100.
  • the feedback slider 8100 is relatively long.
  • the movable portion 3200 moves to the fixed portion 3100, it directly contacts the portion of the feedback slider 8100 that extends beyond the outer surface of the fixed portion 100, thereby pushing the entire feedback
  • the slider 8100 moves toward the proximal end of the fixed portion 3100.
  • one end of the feedback slider 8100 protruding from the third slot 31500 on the outer surface of the fixing portion 3100 is further provided with a telescopic portion 8110 whose length can be adjusted.
  • the first coupling portion 3161 and the second coupling portion 3162 in the boss 3160 are used to adjust the axial length of the boss 3160, thereby adjusting the magnitude of the locking force.
  • the telescopic portion 8110 is used to adjust the size of the lock. It can be understood that the telescopic portion 8110 can be telescopically screwed or snapped.
  • the following are the structural features of the target object 200 and the locking assembly 300 provided by the present invention on the basis of the foregoing embodiments, as well as specific embodiments of using the locking assembly 300 to lock the target object 200.
  • the target object 300 in this embodiment includes a locking nail 1000 and a suture 5000.
  • the locking nail 1000 is used to accommodate or fix the suture 5000 ( Referring to FIG. 20a or FIG. 20b, where FIG. 20a shows before being fixed, and FIG. 20b shows after being fixed), the locking assembly 200 is used to lock the suture 5000 in the locking nail 100.
  • the locking assembly 200 includes an outer tube 2000 and an adjusting device 4000. A cavity 2100 is provided in the outer tube 2000, a locking pin 1000 is disposed at the distal end of the cavity 2100 (see FIG. 33a and FIG. 33b), and the fixing portion 3100 is connected to the outer tube.
  • the adjusting device 4000 is provided on the fixing part 3100, the adjusting device 4000 is connected to the proximal end of the suture 5000, and is used to adjust the tightening or loosening of the suture 5000.
  • the adjusting device 4000 may be any device that can tighten or loosen the suture 5000. Such as cable ties or snaps. It can be understood that the number of the adjusting devices 4000 can be set according to needs.
  • one adjusting device 4000 is provided on both sides of the fixing part 3100 for adjusting two sets of sutures 5000.
  • the adjusting device 4000 includes a wire harness 4100 that is movably connected to the fixing portion 3100, and the wire harness 4100 is connected to the proximal end of the suture 5000 to adjust the tightening or loosening of the suture 5000.
  • the tightening or loosening of the suture 5000 can be adjusted by the wire harness 4100, the length of the elasticity of the suture 5000 can be effectively controlled, and the effect of adjusting a relatively small length can be achieved.
  • one of the thread ties 4100 means that the suture thread 5000 is wound on the thread ties 4100, and the suture thread 5000 is tightened or loosened by changing the winding direction or the winding method.
  • the adjusting device 4000 further includes an adjusting rail 4200, which is provided on the fixing portion 3100, and the wire harness 4100 is connected to the fixing portion 3100 through the adjusting rail 4200.
  • the wire harness 4100 advances or retreats on the adjustment rail 4200 in the axial direction of the adjustment rail 4200, thereby adjusting the tightening or loosening of the suture 5000. It can be understood that the wire harness 4100 adjusts the tightening or loosening of the suture 5000 by rolling on the adjusting rail 4200.
  • the axial direction of the adjusting rail 4200 is the same as the axial direction of the entire locking device 100 or has a preset angle so that the wire harness 4100 rolls on the adjusting rail 4200 to adjust the tightening of the suture 5000 or Relax.
  • the axial direction of the entire locking device 100 refers to the direction from the proximal end to the distal end.
  • the wire harness 4100 includes a suture fixing portion 4110 and a handle connecting portion 4120 connected to each other, and the suture fixing portion 4110 and the suture 5000 are detachably connected .
  • the suture fixing device 4110 can be fixed together with the suture 5000 through winding, clamping, withholding and the like.
  • the handle connection portion 4120 is provided in the adjustment rail 4200 (see FIG. 24 ), and the wire harness 4100 advances or retreats on the adjustment rail 4200 in the axial direction of the adjustment rail 4200 through the handle connection portion 4120.
  • the handle connecting portion 4120 is provided in the adjustment rail 4200 by means such as snapping, to ensure that the wire harness 4100 will not fall off the handle 3000.
  • the suture fixing portion 4110 includes a bobbin 4111 and a first blocking portion 4112 and a second blocking portion 4113 connected to both ends of the bobbin 4111, wherein the second blocking portion 4113 is compared to The first blocking portion 4112 is away from the handle connection portion 4120.
  • the first barrier 4112 and the second barrier 4113 at both ends can effectively block the suture 5000 from falling off the bobbin 4111. It can be understood that the diameters of the first barrier portion 4112 and the second barrier portion 4113 are larger than the diameter of the bobbin 4111.
  • the suture fixing portion 4110 further includes an elastic piece 4114.
  • the elastic piece 4114 is fixed on the second blocking portion 4113.
  • the elastic piece 4114 is used to fix the suture 5000.
  • the second blocking portion 4113 defines a shrapnel receiving groove 4115, and the shrapnel 4114 is received in the shrapnel receiving groove 4115.
  • shrapnel receiving groove 4115 may be provided with a corner shape, and the shrapnel 4114 may be provided with a shape matching the corner.
  • the corner setting makes it difficult for the suture 5000 to fall off from the shrapnel 4114 and be more stably fixed.
  • the adjustment rail 4200 includes a rail cavity 4210 and a rail outer wall 4220
  • the handle connection portion 4120 includes an embedded end 4121 and a connecting shaft 4122
  • the embedded end 4121 is located in the rail cavity 4210 and moves forward and backward in the rail cavity 4210, connected
  • the shaft 4122 is located on the rail outer wall 4220 and moves back and forth on the rail outer wall 4220
  • the insertion end 4121 is connected to the suture fixing portion 4110 through the connecting shaft 4122.
  • the embedding end 4121 is placed in the rail cavity 4210, and the embedding end 4121 is limited in the rail cavity 4210 by the outer wall 4220 of the rail, and is not easy to fall out of the rail cavity 4210.
  • the fifth embodiment of the present invention provides a locking device 100d. 25a, 25b and 26, the locking device 100d differs from the locking device 100 in the first embodiment in that a first tooth 4221 is provided on the outer wall 4220 of the rail and a second is provided on the connecting shaft 4122 The teeth 4123, the first teeth 4221 and the second teeth 4123 are adapted to make the connecting shaft 4122 roll on the outer wall 4220 of the rail.
  • the wire harness 4100 can advance or retreat on the adjustment rail 4200 in the axial direction of the adjustment rail 4200.
  • the wire harness 4100 moves axially along the adjustment track 4210, and the rotation motion of the wire harness 4100 can be converted into a linear motion of the suture 5000, which can accurately realize the collection of the suture 5000 Tight and relaxed.
  • the sixth embodiment of the present invention provides a locking device 100e. See Figure 27 and Figure 28.
  • the locking device 100b differs from the locking device 100 in the first embodiment in that the adjustment device 4000 further includes a lead screw 4300, a bolt 4400, and an adjustment knob 4500, and the lead screw 4300 is along the adjustment track 4200.
  • the axial direction is fixed in the fixing portion 3100
  • the bolt 4400 is fixed in the fixing portion 3100
  • the lead screw 4300 passes through the bolt 4400 and is matched with the bolt 4400.
  • the proximal end of the lead screw 4300 passes through the proximal end of the fixing portion 3100 and is connected to the adjusting knob 4500.
  • the handle connecting portion 4120 is fixed on the lead screw 4300.
  • the adjusting knob 4500 adjusts the lead screw 4300 to move forward or backward in the axial direction.
  • the adjusting knob 4500 drives the lead screw 4300 to limit the rotation in the fixing portion 3100, thereby driving the wire harness 4100 connected to the lead screw 4300 to move forward or backward in the axial direction in the adjusting track 4200.
  • the movable portion 3200 and the fixed portion 3100 can move relative to each other.
  • the locking nail 1000 is provided with a hollow inner cavity 1100 in the axial direction (see FIG. 29).
  • the hollow inner cavity 1100 is used to receive and pass the suture 5000.
  • the locking assembly 200 also includes a crimping assembly 6000 and a mandrel 7000 (see FIG. 19).
  • the pressing assembly 6000 is used to press the locking pin 1000 and deform the locking pin 1000 (please refer to FIG. 20a and FIG. 20b, wherein FIG. 20a shows before deformation and FIG. 20b shows after deformation).
  • the lock nail 1000 may be collapsed when subjected to a mechanical external force to fix the suture 5000 in the lock nail 1000, and will not move relative to the lock nail 1000 again, thereby locking and fixing the suture 5000.
  • the locking pin 1000 can be in various shapes, for example, cylindrical, prismatic, etc., as long as it has a hollow inner cavity 1100 for accommodating the suture 5000. In this embodiment, a cylindrical shape is used to reduce the pressure resistance.
  • the distal end of the mandrel 7000 is connected to the proximal end of the crimping assembly 6000, and the proximal end of the mandrel 7000 is movably connected to the movable portion 3200.
  • the crimping assembly 6000 and the mandrel 7000 are located in the cavity 2100, the movable portion 3200 moves relative to the fixed portion 3100, and the mandrel 7000 is driven to move so that the crimping assembly 6000 crimps the locking nail 1000.
  • the mandrel 7000 exerts a force on the crimping assembly 6000 during the movement, so that the crimping assembly 6000 has a mechanical external force to crimp the locking spike 1000 to crimp the locking spike 1000.
  • the mandrel 7000 can be extended into the fixed part 3100, and the movable connection part 3210 between the movable part 3200 and the mandrel 7000 is located in the fixed part 3100 (see FIGS. 32a and 32b).
  • the hollow cavity 1100 includes an upper surface 1110 and a lower surface 1120 oppositely disposed.
  • the upper surface 1110 is provided with a raised locking platform 1111, and the lower surface 1120 is provided.
  • the upper surface and the lower surface are named when the locking nail 1000 is placed horizontally, and when the locking nail 1000 is placed vertically, it may also be called a left surface and a right surface.
  • the convex lock table 1111 is pressed into the concave lock hole 1121.
  • the lock table 1111 and the lock hole 1121 are deformed at the same time until they cannot At this time, the suture 5000 is firmly fixed in the hollow cavity 1100 of the lock nail 1000.
  • the crimping assembly 6000 includes a collet 6100 and a push rod 6200.
  • the collet 6100 includes an upper clip 6110, a lower clip 6120, and a clip connected to the upper clip
  • the clip connecting portion 6130 between the proximal end of the 6110 and the proximal end of the lower clip 6120, the locking nail 1000 is accommodated between the upper clip 6110 and the lower clip 6120.
  • the proximal end of the push rod 6200 is connected to the distal end of the mandrel 7000.
  • the distal end of the push rod 7000 is disposed near the upper clip 6120.
  • the mandrel 7000 drives the push rod 6200 to move up the clip 6110, thereby pushing the upper clip 6110 down.
  • the piece 6120 moves so that the upper clip 6110 and the lower clip 6120 jointly press the locking pin 1000.
  • the upper clip 6110 and/or the lower clip 6120 are at least partially made of a deformable material, and have a certain elasticity. Therefore, when the upper clip 6110 and/or the lower clip 6120 are subjected to an external force The deformable upper clip 6110 and/or the lower clip 6120 can be moved closer to each other, and the locking nail 1000 placed between the upper clip 6110 and the lower clip 6120 is pressed into a shape with a certain curvature.
  • the upper clip 6110 and the lower clip 6120 are preferably made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other materials
  • the clip connecting portion 6130 is made of stainless steel, nickel-titanium alloy and other materials.
  • the entire chuck 6100 is made of nickel-titanium alloy.
  • the upper clip 6110 includes a first surface 6111 facing the locking pin 1000
  • the lower clip 6120 includes a second surface 6121 facing the locking pin 1000.
  • the first surface 6111 is provided with a A bite portion 6112.
  • the second surface 6121 is provided with a second bite portion 6122.
  • the first bite portion 6112 is adapted to the second bite portion 6122 to close the upper clip 6110 and the lower clip 6120. It can be understood that the first nip portion 6112 and the second nip portion 6122 may have a curvature shape or a zigzag shape that cooperate with each other.
  • the diameter of the circular table 1200 is larger than the diameter of the proximal end portion of the locking pin 1000.
  • the axial length of the upper clip 6110 and the lower clip 6120 are different.
  • the axial distance between the upper clip 6110 and the lower clip 6120 is a preset length. The preset length is at least equal to the thickness of the circular table 1200.
  • the portion of the round table 1200 and the collet 6100 of the non-clamped locking nail 1000 can be placed at the distal end of the outer tube 2000 at the same time without affecting the tube body size of the outer tube 2000.
  • the thickness of the circular table 1200 refers to the length of the circular table 1200 along the axial direction of the locking pin 1000.
  • the distal end of the push rod 6200 includes a first slope 6210 (see FIG. 31), and the first slope 6210 slopes downward from the distal end to the proximal direction.
  • the upper clip 6110 includes a second inclined surface 6113 that faces away from the locking pin 1000, and the second inclined surface 6113 slopes downward from the distal end to the proximal direction to ensure a large contact area between the collet 6100 and the push rod 6200.
  • the slope of the first slope 6210 is smaller than the slope of the second slope 6113.
  • the slope of the first slope 6210 refers to the angle between the first slope 6210 and the direction from the distal end to the proximal end of the push rod 6200
  • the inclination of the second inclined surface 6113 refers to the angle between the second inclined surface 6113 and the direction of the push rod 6200 from the distal end to the proximal end, thus, during the process of the push rod 6200 advancing to the distal end, the push rod
  • the first inclined surface 6210 at the distal end of 6200 can continuously squeeze the second inclined surface 6113 of the upper clip 6110, so that the upper clip 6110 gradually closes to the lower clip 6120, thereby continuously deforming the locking nail 1000 until the locking nail 1000 can no longer be Deformation, at this time, the locking nail 1000 and the suture 5000 are firmly fixed together.
  • the push rod 6200 is made of stainless steel, nickel-titanium alloy or cobalt-chromium alloy, preferably made of stainless steel.
  • the distal end of the push rod 6210 and the proximal end of the push rod 6210 form an L shape.
  • the radial thickness of the distal end of the push rod 6210 is smaller than the radial thickness of the proximal end of the push rod 6210, and the distal end of the push rod 6210 is located on the whole side of the push rod 6210, so that the distal end of the push rod 6210 is close to the push rod 6210
  • the end forms an L-shape.
  • the L-shaped push rod 6200 makes the chuck 6100 be placed between the L-shaped in the crimped state, so that the push rod 6200 presses the overall thickness of the chuck 6100 The difference with the thickness before the chuck 6100 is pressed is small, so as not to affect the size of the outer tube 2000.
  • the push rod 6210 may be a hollow tubular or solid rod-like structure.
  • the distal end of the outer tube 2000 is provided with a suture inlet 2200 in the radial direction, and the diameter of the suture inlet 2200 is at least equal to the outer diameter of the locking pin 1000. The largest diameter.
  • the outer tube 2000 is also provided with a suture outlet 2300. The suture inlet 2200 and the suture outlet 2300 are both in communication with the hollow cavity 1100 of the locking nail 1000.
  • the suture outlet 2300 may be provided at any position of the outer tube 2000 body, or on the handle 3000, as long as the suture outlet 2300 communicates with the hollow lumen 1100 of the locking nail 1000, The proximal end of the suture 5000 can be passed through the suture outlet 2300.
  • the distal end of the outer tube 2000 includes a holding portion 2400 whose diameter gradually decreases from the proximal end to the distal end.
  • the holding portion 2400 is used to prevent the locking nail 1000 from falling off from the distal end of the outer tube 2000 before crimping.
  • the diameter of the holding portion 2400 is gradually reduced from the proximal end to the distal end, which facilitates the distal end of the outer tube 2000 to enter the patient's body and smoothly pass through the body.
  • the holding portion 2400 includes a holding portion end face 2410 at a distal end.
  • the holding portion 2400 is provided with an opening 2420 penetrating the end surface 2410 of the holding portion in the axial direction, and the opening 2420 communicates with the cavity 2100.
  • the opening 2420 is the suture inlet 2200.
  • the opening 2420 is provided with a protrusion 2430 (see FIG. 33a) in the radial direction, and the protrusion 2430 has a preset distance from the end surface 2410 of the holding portion, and a part of the locking nail 1000 is provided in the opening 2420, so that The protrusion 2430 fixes the locking nail 1000.
  • the distal end of the locking pin 1000 is provided with a circular table 1200, and the diameter of the circular table 1200 is larger than the diameter of the proximal portion of the locking pin 1000.
  • the round table 1200 is disposed in the opening 2420, and the protrusion 2430 fixes the locking nail 1000 to prevent the locking nail 1000 from falling off from the distal end of the outer tube 2000.
  • the round table 1200 can also make the transition between the hollow cavity 1100 of the locking nail 1000 and the distal end of the locking nail 1000 as smooth as possible, to avoid cutting sutures or scratching the internal tissues of the patient's body at the connection between the two.
  • the preset distance is at least the thickness of the circular table 1200, so that the circular table 1200 is placed between the protrusion 2430 and the end surface 2410 of the holding portion, which is beneficial to stabilize the locking nail 1000.
  • the circular table 1200 includes an inner surface 1210, and the inner surface 1210 is a curved surface. In order to allow the suture 5000 to smoothly pass through the locking nail 1000, to prevent the locking nail 1000 from cutting the suture 5000 or damaging human tissue.
  • the outer tube 2000 and the mandrel 7000 can be processed from metal materials such as stainless steel, nickel titanium, pure titanium, etc., and can also be processed from polymer materials such as ABS, PS, PEEK, etc. The same can also be different. It is preferably made of stainless steel.
  • the locking pin 1000 is made of stainless steel, pure titanium, nickel titanium, cobalt chromium alloy, etc., preferably pure titanium or stainless steel.
  • the operator When the locking device 100 is in use, the operator first passes the proximal end of the suture 5000 through the suture inlet 2200 at the distal end of the outer tube 2000, the distal opening of the locking nail 1000, and the suture outlet at the distal tube body of the outer tube 2000 in sequence Pass through 2300, and then fix the suture 5000 on the suture fixing part 4110 of the stringer 4100, and then adjust the length of the suture 5000 through the adjustment device 4000 as needed.
  • the movable part 3200 of the handle 3000 is driven to The fixed portion 3100 moves, thereby driving the mandrel 7000 to move distally relative to the outer tube 2000, thereby causing the push rod 6200 to squeeze the collet 6100, and the upper clip 6110 and the lower clip 6120 of the collet 6100 press the locking pin 1000, thereby Deform the lock nail 1000 (see FIG. 33a and FIG. 33b, FIG. 33a is before crimping, and FIG. 33b is after crimping), and the suture 5000 inserted in the lock nail 1000 and the lock nail 1000 are fixed together.
  • the operation process of the locking device 100 of the present invention will be described below by taking the occurrence of a mitral valve as an example.
  • the mitral valve is a unidirectional "valve" between the left atrium (abbreviation: LA) and the left ventricle (abbreviation: LV), which can ensure that blood flows from the left atrium to the left ventricle.
  • LA left atrium
  • LV left ventricle
  • a normal healthy mitral valve has multiple tendons.
  • the leaflets of the mitral valve are divided into the anterior and posterior lobes.
  • the adjustable locking device 100e provided in the sixth embodiment of the present invention for mitral valve repair is as follows.
  • the sixth embodiment may include the features of the locking feedback member 8000 in any of the above embodiments.
  • Step 1 First implant multiple sutures 5000 with elastic pads into the anterior and posterior mitral valves (see Figure 35). The point contact between the suture 5000 and the valve leaflets is transformed into elastic The surface contact between the gasket and the leaflet can effectively reduce the risk of leaflet tearing.
  • Step 2 Thread multiple sutures 5000 on both sides of the valve leaflets into the locking nail 1000 of the locking device 100e outside the patient's body, and suture the proximal end of the suture 5000 from the outer tube 2000 to the distal tube body Pass through the thread outlet 2300 (see Figure 36), distinguish the sutures of the anterior leaflet and the posterior leaflet, wrap the proximal ends of the two sets of sutures 5000 on the spool of a cable tie 4100, and then sew The proximal end of the thread 5000 is fixed on the elastic piece 4114 to maintain the relative position between the suture 5000 and the locking nail 1000 (see FIG. 37).
  • Step 3 Push the distal end of the locking device 100e into the heart through the apex, move closer to the leaflet of the mitral valve, and simultaneously pull the suture 5000 until the distal end of the adjustable suture locking device 100b reaches the predetermined position under the valve (See Figure 37).
  • Step 4 Rotate the two adjusting knobs 4500 respectively to drive the two lead screws 4300 to rotate, and then drive the wire harness 4100 connected to the lead screw 4300 to move back and forth along the axis in the adjusting track 4200 to adjust the wire harness respectively
  • the elasticity of the two sets of suture 5000 connected to 4100, and the lightest state of mitral regurgitation is determined by ultrasound.
  • the rotation of the adjusting knob 4500 is stopped to maintain the elasticity of the two sets of suture 5000, that is Maintain the relative distance between the anterior and posterior leaves of the mitral valve.
  • Step 5 Referring to FIGS. 32a, 32b, 33a, 33b and 37, keep the fixed part 3100 of the handle 3000 stationary and drive the movable part 3200 to move to the fixed part 3100 until the movable part 3200 triggers the locking feedback piece 8000 Sound feedback is given, at this time, the mandrel 7000 and the push rod 6200 move distally relative to the outer tube 2000, and the distal end of the push rod 6200 continuously squeezes the chuck 6100, so that the upper clip 6110 and the lower clip 6120 of the clip 6100 Move closer to each other and press the lock nail 1000 between the upper clip 6110 and the lower clip 6120 until the lock nail 1000 is deformed and the suture 5000 in the lock nail 1000 is fixed in the lock nail 1000, and the movable part 3200 is released.
  • the elastic chuck 6100 is automatically opened, and the deformed lock nail 1000 is released from the suture inlet 2200 at the distal end of the outer tube 2000 of the locking device 100e.
  • Step 6 Withdraw the distal end of the locking device 100e from the patient's body, leave the locking nail 1000 in the patient's body, and fix the proximal end of the suture 5000 on the ventricular wall, at this time the locking nail 1000 will pass through the anterior and posterior leaves, respectively
  • the two sets of sutures 5000 of the leaf are fixed together (see FIG. 38), and the anterior and posterior mitral valves are pulled toward each other to complete edge-to-edge repair, forming a double-pored structure.
  • the present invention also provides a heart valve repair system 10.
  • the heart valve repair system 10 includes the locking device 100 as in any of the foregoing embodiments, and further includes at least one suture 5000.
  • the suture 5000 is used to Implanted on the leaflets of heart valves.
  • the heart valve repair system 10 further includes a suture implanting device 400, the suture implanting device 400 implants the suture 5000 into the leaflet of the heart valve, and the locking device 100 fixes the suture 5000 to the apex of the heart , On the papillary muscle or the wall of the ventricle, the suture 5000 is used as an artificial tendon to form a "tendon cord repair".
  • the suture implanting device 400 implants the suture 5000 into different leaflets of the heart valve, and the locking device 100 fixes the multiple sutures 5000 together, thereby pulling the leaflets toward each other, forming a "edge" Edge repair".
  • the heart valve repair system 10 can lock the suture 5000 through the locking device 100, and can also judge whether it is locked through the locking feedback member 8000 in the locking device 100 to ensure the locking strength of the suture 5000, It can not only prevent the suture 5000 from being locked, but also prevent it from being damaged due to excessive locking and crushing, thereby ensuring the effect of locking and improving the success rate of surgery.

Abstract

本发明提供了一种具有锁紧反馈的锁紧装置，所述锁紧装置包括锁紧组件、手柄及锁紧反馈件，所述锁紧组件用于锁紧目标物件；所述锁紧组件与所述手柄连接，所述手柄包括活动部和固定部，所述活动部相对所述固定部移动以驱动所述锁紧组件锁紧目标物件；所述锁紧反馈件活动地设置在所述固定部中，并与所述手柄的活动部配合作用以反馈所述目标物件是否锁紧。本发明还提供一种心脏瓣膜修复系统。本发明提供的具有锁紧反馈的锁紧装置，在用于锁紧目标物件时，能够通过锁紧反馈件来判断目标物件是否被锁紧组件锁紧，能够保证目标物件的锁紧程度，从而保证锁紧效果，提高手术成功率。

Description

具有锁紧反馈的锁紧装置及心脏瓣膜修复系统 技术领域
本发明涉及医疗器械领域，具体涉及一种具有锁紧反馈的锁紧装置及心脏瓣膜修复系统。
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，通常可由医生手动打结。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，这类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，如需对缝合线进行打结或固定操作，通常需要操作者通过较小的操作窗口，在患者体外进行远程操作，对患者体内的缝合线进行打结。现有技术中，通常采用手术机器人、线结推送器或经导管缝合线锁扣植入系统等方法对缝合线进行远距离打结或固定。
常用的可植入体内的缝线通常采用PET或者PTFE制成，其中PTFE缝合线通常是单股线，并且PTFE本身是高分子材料，当被锁扣、锁钉等金属件过量压紧时，压紧点容易出现压伤或压断，导致缝合线在植入体内短期就被拉断或者在长期使用后容易疲劳断裂；而如果操作者在锁紧时用力不足，导致金属件没有将缝合线锁紧又会出现滑脱。
现有技术US7235086B2公开了一种缝合线的锁紧装置，通过一个具有中空内腔的锁钉及与锁钉配套的锁结器来固定穿设在锁钉内腔中的缝合线，但是这种结构的锁紧装置用于锁定缝合线时，无法有效判断缝合线是否锁紧或者过量锁紧。
发明内容
有鉴于此，针对上述现有技术的缺陷，本发明提供一种具有锁紧反馈的锁紧装置。在用于微创外科或者介入手术中锁紧缝合线时，可通过锁紧反馈来判断是否锁紧，保证缝合线的锁紧力度，既能防止缝合线未锁紧又能防止被过量锁紧压伤而出现断线失效，从而保证锁结效果，提高手术成功率。具体技术方案如下所述。
一种具有锁紧反馈的锁紧装置，其特征在于，所述锁紧装置包括：
锁紧组件，所述锁紧组件用于锁紧目标物件；
手柄，所述锁紧组件与所述手柄连接，所述手柄包括活动部和固定部，所述活动部相对所述固定部移动以驱动所述锁紧组件锁紧目标物件；
锁紧反馈件，所述锁紧反馈件活动地设置在所述固定部中，并与所述手柄的活动部配合作用以反馈所述目标物件是否锁紧。
本发明还提供一种心脏瓣膜修复系统，所述心脏瓣膜修复系统包括如上述任一项所述的锁紧装置，还包括至少一根缝合线，所述缝合线用于植入在心脏瓣膜的瓣叶上。
本发明与现有技术相比，至少具有以下有益效果：本发明提供的具有锁紧反馈的锁紧 装置，在用于锁紧目标物件时，能够通过锁紧反馈件来判断目标物件是否被锁紧组件锁紧，能够保证目标物件的锁紧程度，从而保证锁紧效果，提高手术成功率。本发明提供的心脏瓣膜修复系统，先在心脏瓣膜的一片或不同瓣叶上植入缝合线，再通过锁紧装置将缝合线固定在心尖、乳头肌或者心室壁上，或者通过锁紧装置将多根所述缝合线固定在一起，在锁紧的过程中，能够通过锁紧反馈件来判断缝合线是否被锁紧，保证缝合线的锁紧程度，从而保证锁紧效果，提高手术成功率；并且可以防止缝合线被过量锁紧导致的压伤或断裂，避免缝合线断裂。
附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领普通技术人员来讲，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为本发明第一实施例提供的一种具有锁紧反馈的锁紧装置的结构示意图；
图2为第一实施例的一种具有锁紧反馈的锁紧装置的内部剖视图；
图3为第一实施例的锁紧反馈件与固定部的立体结构分解示意图；
图4为图3中的锁紧反馈件的后视图；
图5a为图3中的锁紧反馈件的左视图；
图5b为图5a中沿A-A线的剖视图；
图6为图3中的M部分的局部放大图；
图7为图2中的N部分的局部放大图；
图8为本发明第二实施例提供的一种具有锁紧反馈的锁紧装置中的锁紧反馈件的结构示意图；
图9为图8的后视图；
图10a为图8的左视图；
图10b为图10a中沿A-A线的剖视图；
图11为第二实施例中的锁紧反馈件在锁紧装置锁紧后的状态示意图；
图12a为第二实施例中的锁紧反馈件在固定部中的初始状态示意图；
图12b为图12a中S部分的局部放大图；
图12c为第二实施例中的锁紧反馈件在固定部中的锁紧反馈后的状态示意图；
图12d为图12c中T部分的局部放大图；
图13a和图13b为本发明第三实施例提供的一种具有锁紧反馈的锁紧装置中的活动部的结构示意图；
图14为本发明第四实施例提供的一种具有锁紧反馈的锁紧装置的结构示意图；
图15为图14中R部分的局部放大图；
图16a为图1中的锁紧装置在锁紧反馈前的示意图；
图16b为图16a中的锁紧装置的内部结构示意图；
图17a为图1中的锁紧装置在锁紧反馈后的示意图；
图17b为图17a的内部结构示意图；
图18为图17b中W部分的局部放大图；
图19为本发明提供的一种锁紧装置中的锁紧组件的分解示意图；
图20a和图20b分别为本发明提供的锁钉在固定缝合线前后的示意图；
图21a至图21c为图19中手柄部分的结构示意图；
图22a和图22b为本发明提供的一种锁紧组件中束线器的结构示意图；
图23为图22中缝合线固定部的结构示意图；
图24为图21c中A部分的局部放大图；
图25a为本发明第五实施例提供的一种锁紧装置中手柄部分的结构示意图，图25b是图25a的B-B剖面图；
图26为图25b部分的局部放大图；
图27为本发明第六实施例提供的一种锁紧装置的爆炸图；
图28为图27中的其中一调节装置的结构示意图；
图29为本发明提供的锁钉的结构示意图；
图30为本发明提供的锁钉的另一种形式的结构示意图；
图31为本发明提供的压握组件的结构示意图；
图32a和图32b为本发明提供的一种锁紧装置中压握锁钉的示意图；
图33a和图33b分别为图32b在C处的局部放大图；
图34a和图34b为本发明提供的一种锁紧装置中保持部的结构示意图；
图35至图38为本发明第六实施例提供的锁紧装置用于二尖瓣瓣膜修复的过程示意图，其中，图35为向瓣叶的前叶和后叶分别植入缝合线的示意图；图36为将缝合线穿入锁紧装置的示意图；图37为本发明提供的用锁紧装置调节缝合线长度和压握锁钉的示意图；图38为本发明提供的将缝合线近端通过锁钉固定在心室壁的示意图；
图39为本发明提供的一种心脏瓣膜修复系统的结构示意图。
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，本领普通技术人员在没有做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。
方位定义：以下将靠近操作者的方位定义为近端，远离操作者的方位定义为远端。除非另有定义，本发明所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本发明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，并不能理解为对本发明的限制。
请参阅图1和图2，本发明提供一种具有锁紧反馈的锁紧装置100，锁紧装置100包 括锁紧组件200、手柄3000以及锁紧反馈件8000。锁紧组件200用于锁紧目标物件300(参阅图2)，锁紧组件200与手柄3000连接，手柄3000包括固定部3100和活动部3200，活动部3200相对固定部3100可以移动以驱动锁紧组件200锁紧目标物件300(参阅图16a至图17b)。锁紧反馈件8000活动地设置在固定部3100中，并与手柄3000的活动部3200的配合作用以反馈目标物件300是否锁紧。手柄3000的活动部3200和固定部3100相对运动，进而驱动锁紧组件200锁紧目标物件300，因此操作者在操作活动部3200和固定部3100时，同时作用锁紧反馈件8000，使锁紧反馈件8000的反馈效果与手柄3000的操作同步，进而可以准确反馈锁紧组件200对目标物件300的锁紧程度。
本发明提供的具有锁紧反馈的锁紧装置100，在用于锁紧目标物件300时，能够通过锁紧反馈件8000来判断目标物件300是否被锁紧组件200锁紧，能够保证目标物件300的锁紧程度，从而保证锁紧效果，提高手术成功率。
在进一步的实施例中，锁紧反馈件8000通过外露于固定部3100或者与固定部3100撞击产生声音来反馈目标物件300是否锁紧。当锁紧组件200锁紧目标物件300时，锁紧反馈件8000与固定部3100撞击发出声音，用以提示操作者目标物件300已经达到目标锁紧程度，此时完成锁紧操作，通过锁紧反馈件8000与固定部3100撞击的声音来反馈，不仅使得判断更及时，而且操作者无需低头查看锁紧装置100即可获知锁紧状态，更利于操作者在手术过程中实时观察超声设备等医用影像装置。当采用声音来反馈时，锁紧反馈件8000与固定部3100撞击的部分采用较硬质的材料制成，从而在撞击时能够产生清脆的撞击音。在其他实施例中，还可以通过锁紧反馈件8000中的部分单元凸出初始位置或者是采用弹跳件来反馈目标物件300是否锁紧。
请参阅图3至图7，在进一步的实施例中，锁紧反馈件8000包括反馈滑块8100、支撑件8200以及连接在反馈滑块8100与支撑件8200之间的弹性件8300(参阅图6)。其中，反馈滑块8100在活动部3200的作用下朝固定部3100的近端移动，支撑件8200跟随反馈滑块8100移动。固定部3100设有第一槽口3110，支撑件8200移动至第一槽口3110时落入第一槽口3110中时，锁紧反馈件8000外露于固定部3100或者与固定部3100撞击产生声音，以反馈出目标物件300锁紧。其中弹性件8300用于当支撑件8200移动至第一槽口3110时，恢复至自然状态，从而作用支撑件8200落入第一槽口3110中(参阅图6)。可以理解的是，当支撑件8200未到达第一槽口3110时，弹性件8300处于压缩状态。可以理解的是，第一槽口3110可设置在固定部3100的外壳表面上。
请参阅图6和图7，在进一步的实施例中，固定部3100中设有第一限位槽3120和第二限位槽3130。具体的，固定部3100包括朝活动部3200凸设的安装框3300(参阅图7)，安装框3300包括延伸板3310及设置于延伸板3310的边缘的凸缘3320，延伸板3310上平行间隔地开设有第一限位槽3120和第二限位槽3130，第一限位槽3120与第二限位槽3130均沿远端至近端的方向延伸。反馈滑块8100在活动部3200的作用下能在第一限位槽3120中向固定部3100的近端移动。支撑件8200在第二限位槽3130中与反馈滑块8100能朝同一方向移动，邻近第二限位槽3130的边缘上开设有第一槽口3110，第一槽口3110与第二 限位槽3130连通，第一槽口3110邻近固定部3100的近端设置且贯穿固定部3100的底端D方向的外表面，支撑件8200移动至正对第一槽口3110时，在弹性件8300的作用下落入第一槽口3110中。
其中所述固定部3100的底端D是指锁紧装置100的近端指向远端方向的垂直方向的端部。也就是说，在该实施例中，当锁紧反馈件8000在活动部3200的作用下，在固定部3100中自固定部3100的远端向近端移动，当支撑件8200移动至第一槽口3110中时，支撑件8200朝向固定部3100的底端D方向落入第一槽口3110中。可以理解的是，可通过设置支撑件8200的长度，以使支撑件8200落入第一槽口3110中时自第一槽口3110中伸出固定部3100的底端D外表面，此时操作者看到自第一槽口3110伸出的部分支撑件8200时，提示操作者锁紧装置100已经将目标物件300锁紧。
在进一步的实施例中，锁紧反馈件8000还包括撞击件8400，弹性件8300弹性抵推撞击件8400，支撑件8200设置在撞击件8400背离弹性件8300的一侧；当支撑件8200正对第一槽口3110时，弹性件8300推动撞击件8400撞击固定部3100发出声音来反馈目标物件300已经锁紧，且支撑件8200落入第一槽口3110内。可以理解的是，支撑件8200与撞击件8400之间可通过卡扣、螺钉或者胶黏剂连接，也可以一体成型。支撑件8200落入第一槽口3110中时，撞击件8400被弹性件8300挤压在固定部3100的底端D上，由于撞击件8400设置在支撑件8200的上方，支撑件8200在弹性件8300的作用下落入第一槽口3110时，弹性件8300同样对撞击件8400施加作用力，而使撞击件8400撞击固定部3100的底端D上表面，并定位于固定部3100中。当撞击件8400与固定部3100撞击的部分采用硬质材料支撑，此时会发生响音，通过撞击响音提示操作者目标物件300锁紧完成。可以理解的是，撞击件8400根据固定部3100的结构设置可卡位在相应的位置，也就是说，撞击件8400卡位的位置可以多样。
在进一步的实施例中，撞击件8400的横截面积大于第一槽口3110的横截面积，以使支撑件8200落入第一槽口3110中时，撞击件8400能抵顶于在第一槽口3110的上方。
请再次参阅图6，在进一步的实施例中，第二限位槽3130包括第一支撑面3131，支撑件8200在第一支撑面3131上滑动，第一槽口3110穿通第一支撑面3131，其中第一槽口3110邻近固定部3100的近端设置。
支撑件8200落入第一槽口3110中时，撞击件8400定位在第一槽口3110的四周的第一支撑面3131上。可以理解的是，第一支撑面3113是位于第一槽口3110远端方向的支撑面。当第一支撑面3131和撞击件8400均采用硬质材料制成时，撞击件8400在弹性件8300的驱动下撞击在第一支撑面3131上时，会发出声音。其中撞击件8400包括撞击面8410(参阅图6)，撞击面8410为设置在撞击件8400背朝弹性件8300的一面，该撞击面8410用于与固定部3100撞击，在该实施例中，撞击面8410用于与第一支撑面3131撞击。
在进一步的实施例中，第二限位槽3130还包括第二支撑面3132，第二支撑面3132与第一支撑面3131设置在第一槽口3110的两侧，且第二支撑面3132与第一支撑面3131在同一水平面上。支撑件8200落入第一槽口3110中时，撞击件8400卡在第一槽口3110两 侧的部分第一支撑面3131上和部分第二支撑面3132上。在该实施例中，撞击件8400同时撞击第一支撑面3131和第二支撑面3132，采用两个支撑表面支撑撞击件8400，增加撞击时响音大小，同时可进一步避免撞击件8400从第一槽口3110中脱落。
可以理解的是，第二限位槽3130还可以包括第三支撑面3133(参阅图6)，第三支撑面3133设置在第一支撑面3131和第二支撑面3132之间，第三支撑面3133、第一支撑面3131和第二支撑面3132三个支撑面共同用于与撞击件8400中撞击面8410撞击，以使撞击音更响亮。
在进一步的实施例中，锁紧反馈件8000还包括反馈按钮8600(参阅图4或者图9)，反馈按钮8600包括按钮部8610和第二连接部8620，按钮部8610通过第二连接部8620连接撞击件8400，且按钮部8610外露于固定部3100的底端D的外表面(参阅图6和图7)。当支撑件8200落入第一槽口3110时，撞击件8400在弹性件8300的作用向固定部3100的底部运动，同时带动反馈按钮8600上的按钮部8610运动，由于按钮部8610外露于固定部3100底端D的外表面，操作者可通过观察按钮部8610与固定部3100底端D的相对位置距离来判断目标物件300是否锁紧，反馈锁紧状态。可以理解的是，按钮部8610可采用较鲜艳的颜色、或者采用易观察的形状设置。在该实施例中，同样也可以通过响音来反馈锁紧状态。
请再次参阅图6，在进一步的实施例中，固定部3100还包括第二槽口3140，第二槽口3140沿第二限位槽3130延伸，并贯穿第二限位槽3130及固定部3100的底端D的外表面。第二连接部8620自第二槽口3140穿出，当反馈滑块8100在第一限位槽3110中滑动时，第二连接部8620在第二槽口3140中移动，以带动外露于固定部3100底端D的按钮部8610移动。其中第二槽口3140的大小跟第二连接部8620相适配。在其他实施例中，第二槽口3140还可以开设在固定部3100的侧面。
在进一步的实施例中，当支撑件8200抵顶第二限位槽3130中的第一支撑面3131时，按钮部8610与固定部3100背离第二限位槽3130的外表面的距离小于预设距离。也就是说按钮部8610与固定部3100的底端D表面的距离小于预设距离，优选的，预设距离为零，也就是按钮部8610与固定部3100的底端D表面相贴接。
在进一步的实施例中，当支撑件8100落入第一槽口3110后，反馈按钮8600还用于向反馈滑块8100按压至支撑件8200位于第二限位槽3130中时，再向固定部3100的远端推进，以使反馈按钮8600、支撑件8200以及反馈滑块8100复位。复位之后，锁紧反馈件8000可重新用于反馈目标物件300是否被锁紧。使得该锁紧装置100在操作过程中可以反复使用。
在进一步的实施例中，按钮部8610背朝第二连接部8620的表面上设有齿纹8611(参阅图4)或者突起部。在按钮部8610上设置的齿纹部8611或者突起部可以增加操作者与按钮部8610之间的摩擦力，使得在操作反馈按钮8600复位支撑件8200和反馈滑块8100时更快更方便。
请再次参阅图6和图7，在进一步的实施例中，固定部3100还包括第三槽口3150， 第三槽口3150的开口方向与反馈滑块8100的移动方向一致，活动部3200通过第三槽口3150推动反馈滑块8100移动。第三槽口3150的开口大小可根据实际情况来设定。
在进一步的实施例中，活动部3200对应于第三槽口3150的位置设有凸台3160(参阅图7)；当活动部3200向固定部3100移动时，凸台3160抵接反馈滑块8100并推动反馈滑块8100在第一限位槽3120中移动。凸台3160用于给反馈滑块8100施加作用力点，可以更有效的推动反馈滑块8100。
在进一步的实施例中，弹性件8300包括弹簧、弹片或者弹力球中的一种。在图4和图9中，示出了弹性件8300采用弹簧的示意图。
为了更好的说明本发明的技术方案，下面以第一实施例为例来说明本发明的工作过程。
请参阅图16a至图18，在本实施例中，锁紧组件200利用夹头6100(参阅图33a和图33b)夹紧目标物件300，目标物件300为锁钉1000和穿装在锁钉1000中的多根缝合线5000。请参阅图16a、图16b、图6及图7，当锁紧组件200在未锁紧目标物件300时，手柄3000的活动部3200与固定部3100处于相离状态，此时锁紧反馈件8000中的支撑件8200位于第二限位槽3130中，且弹性件8300处于压缩状态(参阅图6和图7)。请参阅图17a、图17b及图18，当锁紧组件200锁紧目标物件300时，活动部3200向固定部3100移动，活动部3200上的凸台3160抵接反馈滑块8100在第一限位槽3120中移动，带动整个锁紧反馈件8000向固定部3100的近端移动，其中支撑件8200在第二限位槽3130中移动，当支撑件8200移动至正对于第一槽口3110时，弹性件8300恢复初始状态，而对支撑件8200施加作用力，使支撑件8200落入第一槽口3110中，此时撞击件8400与第二限位槽3130撞击，发出响音，提示操作者目标物件300锁紧完成，即多根缝合线5000被固定在锁钉1000中。
请参阅图8至图12d，本发明第二实施例提供一种具有锁紧反馈的锁紧装置100a，在锁紧装置100a中，锁紧反馈件8000还包括至少一个倒扣8500，倒扣8500包括第一连接部8510和卡位部8520，卡位部8520通过第一连接部8510连接在反馈滑块8100的下方，撞击件8400与卡位部8520在反馈滑块8100上的正投影至少部分重叠，支撑件8200落入第一槽口3110中时，撞击件8400抵顶在卡位部8520上(参阅图11)。在该实施例中，当支撑件8200落入第一槽口3110中时，弹性件8300同时作用撞击件8400撞击卡位部8520而发出响音，也就是撞击件8400的撞击面8410撞击卡位部8520(参阅图12d)。将撞击件8400与卡位部8520在反馈滑块8100上的正投影设置至少部分重叠，以保证撞击件8400卡在卡位部8520上。
在进一步的实施例中，倒扣8500为两个，且设置在撞击件8400相对的两侧，支撑件落入第一槽口3110中时，撞击件8400抵顶在两个倒扣8500的卡位部8520上。在其他一些实施例中，倒扣8500的个数还可以是多个。
请参阅图13a和图13b，本发明第三实施例提供一种具有锁紧反馈的锁紧装置，在图13a和图13b仅示出了活动部3200部分，其他部分与第一实施例相同。在手柄3000的活动 部3200上设置另一种凸台3160。在该实施例中，凸台3160包括第一结合部3161和第二结合部3162，第一结合部3161与第二结合部3162之间相对伸缩，以调节凸台3160的轴向长度。凸台3160通过第一结合部3161和第二结合部3162来调节轴线长度，从而可以反馈不同的锁紧力效果。当目标物件300为锁钉1000和缝合线5000时，更利于针对不同规格的缝合线5000，或者同规格但不同数量的缝合线5000，以及针对不同规格的锁钉1000(即外径相同的锁钉1000，由于内径不同导致锁钉1000的壁厚不同，从而实现锁紧的压握力度不同)分别调节锁紧力的大小。例如：当锁钉1000内部的缝合线5000数量增加或者锁钉1000的壁厚增加时，仅需较小的力度即可使得夹头6100(参阅图33a和图33b)压握锁钉1000至锁钉1000变形，此时可以调节第二结合部3162，增加凸台3160的总体轴向长度，缩短达到锁紧反馈状态时的行程。
在进一步的实施例中，第一结合部3161与第二结合部3162相对伸缩的方式包括螺纹伸缩或者卡扣伸缩。
在进一步的实施例中，当采用螺纹伸缩时，第一结合部3161和第二结合部3162分别为螺纹件和螺纹旋盖中的一个，螺纹旋盖与螺纹件相适配。在本实施例中，第一结合部3161采用螺纹件，第二结合部3162采用螺纹旋盖，将螺纹件设置在活动部3200上，通过螺纹旋盖与螺纹件的相对转动来调节凸台3160的轴向长度。在其他实施例中，还可以将螺纹旋盖设置在活动部3200上，通过螺纹件的相对转动来调节凸台3160的轴向长度。
请参阅图14和图15，本发明第四实施例提供一种具有锁紧反馈的锁紧装置100c。在锁紧装置100c中，当支撑件8200位于第二限位槽3130中时，反馈滑块8100自第三槽口3150伸出固定部3100的外表面。也就是说，在该实施例中，反馈滑块8100比较长，在活动部3200向固定部3100活动时，会直接抵接反馈滑块8100伸出固定部100外表面的部分，进而推动整个反馈滑块8100向固定部3100的近端移动。
在进一步的实施例中，反馈滑块8100自第三槽口31500伸出固定部3100的外表面的一端还设有长度可调节的伸缩部8110。在图13a中，通过凸台3160中的第一结合部3161和第二结合部3162来实现调节凸台3160的轴向长度，进而调节锁紧力的大小。在该实施例中，采用伸缩部8110来调节锁紧里的大小。可以理解的是，伸缩部8110可以采用螺纹伸缩或者卡扣伸缩的方式来实现伸缩。
可以理解的是，本发明其他实施例与上述第一实施例的工作原理相类似，不再重复描述。
下面为本发明在上述实施例的基础上提供的关于目标物件200和锁紧组件300的结构特征，以及利用锁紧组件300锁紧目标物件200的具体实施例方式。
请参阅图19、图20a和图20b，在第一实施例的基础上，本实施例中的目标物件300包括锁钉1000和缝合线5000，锁钉1000用于容置或者固定缝合线5000(参阅图20a或者图20b，其中图20a表示未固定前，图20b表示固定后)，锁紧组件200用于将缝合线5000锁紧在锁钉100中。锁紧组件200包括外管2000和调节装置4000，外管2000中设有容腔2100，锁钉1000设置在容腔2100的远端(参阅图33a和图33b)，固定部3100与外管的 近端连接；调节装置4000设于固定部3100上，调节装置4000与缝合线5000近端连接，且用于调节缝合线5000的收紧或者放松。可以理解的是，调节装置4000可以为任意一种能够将缝合线5000收紧或者放松的装置。例如束线器或者卡扣。可以理解的是，调节装置4000的个数可根据需要来设置，优选的是，在固定部3100的两侧分别设置一个调节装置4000，用于调节两组缝合线5000。
请参阅图21a至图21c。在进一步的实施例中，调节装置4000包括束线器4100，束线器4100活动连接在固定部3100上，束线器4100与缝合线5000近端连接以调节缝合线5000的收紧或者放松。通过束线器4100来调节缝合线5000的收紧或者放松，能够有效的控制缝合线5000松紧的长度，且能够达到调节比较微小的长度的效果。例如其中一种束线器4100是指通过将缝合线5000缠绕在束线器4100上，通过缠绕方向或缠绕方式的改变实现缝合线5000收紧或者放松。
调节装置4000还包括调节轨道4200，调节轨道4200设置在固定部3100上，束线器4100通过调节轨道4200连接在固定部3100上。束线器4100在调节轨道4200上沿调节轨道4200的轴向方向前进或者后退，从而调节缝合线5000的收紧或者放松。可以理解的是，束线器4100是通过在调节轨道4200上滚动来调节缝合线5000的收紧或者放松。可以理解的是，调节轨道4200的轴向方向与锁紧装置100整体的轴向方向一致或者具有预设角度以使束线器4100在调节轨道4200上滚动而能够调节缝合线5000的收紧或者放松。其中锁紧装置100整体的轴向方向是指从近端指向远端的方向。
请一并参阅图22a及图22b，在进一步的实施例中，束线器4100包括相互连接的缝合线固定部4110和手柄连接部4120，缝合线固定部4110与缝合线5000之间可拆卸连接。其中，缝合线固定装置4110可通过缠绕、卡压、扣压等方式与缝合线5000固定在一起。手柄连接部4120设置在调节轨道4200中(参阅图24)，束线器4100通过手柄连接部4120在调节轨道4200上沿调节轨道4200的轴向方向前进或者后退。手柄连接部4120通过卡合等方式设置在调节轨道4200中，保证束线器4100不会从手柄3000上脱落。
请参阅图22b，在进一步的实施例中，缝合线固定部4110包括绕线轴4111及连接在绕线轴4111两端的第一阻挡部4112和第二阻挡部4113，其中第二阻挡部4113相较于第一阻挡部4112远离手柄连接部4120。当缝合线5000缠绕在绕线轴4111上时，两端的第一阻挡部4112和第二阻挡部4113能够有效阻挡缝合线5000从绕线轴4111上脱落。可以理解的是，第一阻挡部4112和第二阻挡部4113的直径大于绕线轴4111的直径。
请参阅图22a，在进一步的实施例中，缝合线固定部4110还包括弹片4114，弹片4114固定在第二阻挡部4113上，弹片4114用于固定缝合线5000。请参阅图23，可以理解的是，第二阻挡部4113开设有弹片收容沟4115，弹片4114收容于弹片收容沟4115中。当缝合线5000在绕线轴4111上缠绕数圈后，将缝合线5000的近端固定在弹片4114上，并收容于弹片收容沟4115中，以将缝合线5000的近端固定在束线器4100上。可以理解的是，弹片收容沟4115可设置成具有转角的形状，弹片4114设置成与转角相适配的形状，转角的设置使缝合线5000不容易从弹片4114上脱落，更稳定地固定。
请参阅图21a至图21c和图24。在进一步的实施例中，调节轨道4200包括轨道腔4210和轨道外壁4220，手柄连接部4120包括嵌入端4121和连接轴4122，嵌入端4121位于轨道腔4210中且在轨道腔4210中前后移动，连接轴4122位于轨道外壁4220上且在轨道外壁4220上前后移动，嵌入端4121通过连接轴4122与缝合线固定部4110连接。将嵌入端4121置于轨道腔4210中，通过轨道外壁4220将嵌入端4121限位在轨道腔4210中，不易从轨道腔4210脱落出来。
本发明第五实施例提供一种锁紧装置100d。请参阅图25a图25b和图26，锁紧装置100d与第一实施例中的锁紧装置100不同的是，在轨道外壁4220上设有第一齿牙4221，连接轴4122上设有第二齿牙4123，第一齿牙4221和第二齿牙4123相适配以使连接轴4122在轨道外壁4220上滚动。进而使束线器4100能够在调节轨道4200上沿调节轨道4200的轴向方向前进或者后退。当操作者旋转束线器4100时，束线器4100沿着调节轨道4210轴向运动，束线器4100的旋转运动可以转化成缝合线5000的直线运动，进而可以精确地实现缝合线5000的收紧和放松。
本发明第六实施例提供一种锁紧装置100e。请参阅图27和图28。在进一步的实施例中，锁紧装置100b与第一实施例中的锁紧装置100不同的是，调节装置4000还包括导螺杆4300、螺栓4400和调节旋钮4500，导螺杆4300沿调节轨道4200的轴向方向固定在固定部3100中，螺栓4400固定在固定部3100中，且导螺杆4300穿过螺栓4400并与螺栓4400相适配。导螺杆4300的近端穿出固定部3100的近端并与调节旋钮4500相连接。手柄连接部4120固定在导螺杆4300上。调节旋钮4500调节导螺杆4300沿轴向前进或者后退。当操作者旋转调节旋钮4500，调节旋钮4500带动导螺杆4300在固定部3100中限位转动，从而带动与导螺杆4300相连的束线器4100在调节轨道4200中沿轴向前进或后退。
请再次参阅图19。在进一步的实施例中，活动部3200与固定部3100之间可相对运动，锁钉1000沿轴向设有中空内腔1100(请参阅图29)，中空内腔1100用于容纳并通过缝合线5000。锁紧组件200还包括压握组件6000和芯轴7000(参阅图19)。压握组件6000用于压握锁钉1000并使锁钉1000变形(请参阅图20a和图20b，其中图20a表示未变形前，图20b表示变形后)。锁钉1000受到机械外力作用时可被压瘪，以将缝合线5000固定在锁钉1000中，不会与锁钉1000再发生相对移动，从而锁紧并固定缝合线5000。锁钉1000可以是多种形状，例如，圆柱形、棱柱形等，只要具有中空内腔1100用于容纳缝合线5000的任何形状均可以。本实施例中采用圆柱形以减小压握阻力。
芯轴7000的远端与压握组件6000的近端连接，芯轴7000的近端与活动部3200之间活动连接。压握组件6000及芯轴7000位于容腔2100中，活动部3200相对固定部3100运动，驱动芯轴7000运动以使压握组件6000压握锁钉1000。可以理解的是，芯轴7000在运动的过程中给压握组件6000施加作用力，进而使压握组件6000具有压握锁钉1000的机械外力，以将锁钉1000压握。其中芯轴7000可延伸至固定部3100中，活动部3200与芯轴7000之间的活动连接部3210位于固定部3100中(参阅图32a和图32b)。
请参阅图30，在进一步的实施例中，在锁钉1000中，中空内腔1100包括相对设置的 上表面1110和下表面1120，上表面1110设有凸起的锁台1111，下表面1120设有凹入的锁孔1121，锁台1111和锁孔1121相适配。可以理解的是，上表面和下表面是将锁钉1000水平放置时来命名的，当锁钉1000是垂直放置时也可称为左表面和右表面。当锁钉1000受到外部的压握力作用，开始变形时，凸起的锁台1111被压入凹入的锁孔1121中，当锁钉1000继续变形，锁台1111和锁孔1121同时变形直至无法分离，此时，缝合线5000被牢固地固定在锁钉1000的中空内腔1100中。
请参阅图31和图33a和图33b，在进一步的实施例中，压握组件6000包括夹头6100和推杆6200，夹头6100包括上夹片6110、下夹片6120以及连接在上夹片6110近端和下夹片6120近端之间的夹片连接部6130，锁钉1000容置在上夹片6110和下夹片6120之间。推杆6200的近端与芯轴7000的远端连接，推杆7000的远端靠近上夹片6120设置，芯轴7000驱动推杆6200向上夹片6110移动，进而推动上夹片6110向下夹片6120移动以使上夹片6110和下夹片6120共同压握锁钉1000。
可以理解的是，上夹片6110和/或下夹片6120至少部分由可变形的材料制成，具有一定弹性，由此，当上夹片6110和/或下夹片6120在受到外力作用时，可变形的上夹片6110和/或下夹片6120可以相互靠拢，将放置在上夹片6110和下夹片6120之间的锁钉1000压握成具有一定曲率的形状。可以理解的是，上夹片6110和下夹片6120优选由不锈钢、镍钛合金、钴铬合金等材料制成，夹片连接部6130由不锈钢、镍钛合金等材料制成，本实施例中，整个夹头6100均由镍钛合金制成。
请继续参阅图31，在进一步的实施例中，上夹片6110包括朝向锁钉1000的第一表面6111，下夹片6120包括朝向锁钉1000的第二表面6121，第一表面6111设有第一咬合部6112，第二表面6121设有第二咬合部6122，第一咬合部6112与第二咬合部6122相适配以使上夹片6110和下夹片6120之间闭合。可以理解的是，第一咬合部6112与第二咬合部6122可以是具有相互配合的曲率形状或者锯齿形状。
当锁钉1000的远端设有圆台1200(参阅图30)，圆台1200的直径大于锁钉1000的近端部分的直径。为配合具有圆台1200的锁钉1000，在进一步的实施例中，上夹片6110与下夹片6120的轴向长度不相同。优选的，上夹片6110与下夹片6120的轴向之间相差预设长度。预设长度至少等于圆台1200的厚度。由此，未压握的锁钉1000的圆台1200部分和夹头6100可以同时放置在外管2000远端并且不影响外管2000的管体尺寸。其中圆台1200的厚度是指圆台1200沿锁钉1000轴向的长度。
在进一步的实施例中，推杆6200的远端包括第一斜面6210(参阅图31)，第一斜面6210由远端向近端方向向下倾斜。上夹片6110包括背向锁钉1000的第二斜面6113，第二斜面6113由远端向近端方向向下倾斜，以保证夹头6100与推杆6200之间具有较大的接触面积。优选地，第一斜面6210的斜度小于第二斜面6113的斜度，第一斜面6210的斜度是指第一斜面6210与推杆6200的由远端向近端的方向之间的夹角，第二斜面6113的斜度是指第二斜面6113与推杆6200的由远端向近端的方向之间的夹角，由此，在推杆6200向远端前进的过程中，推杆6200远端的第一斜面6210可以持续地挤压上夹片6110的第二斜面 6113，使上夹片6110逐渐向下夹片6120靠拢，进而使锁钉1000不断变形，直至锁钉1000无法再变形，此时锁钉1000与缝合线5000牢固地固定在一起。推杆6200由不锈钢、镍钛合金或者钴铬合金制成，优选由不锈钢制成。
可以理解的是，推杆6210远端与推杆6210近端构成L型。也就是说推杆6210远端的径向厚度小于推杆6210近端的径向厚度，且推杆6210远端位于推杆6210整体的一侧，以使推杆6210远端与推杆6210近端构成L型。当推杆6200向前推进并下压夹头6100后，L型的推杆6200使夹头6100在压握状态时置于L型之间，使得推杆6200压握夹头6100后整体的厚度与夹头6100压握之前的厚度相差较小，避免影响外管2000的管体尺寸。
可以理解的是，推杆6210可以为空心管状或实心杆状结构。
请参阅图32a、图32b和图33a和图33b，在进一步的实施例中，外管2000的远端沿径向设有缝合线入口2200，缝合线入口2200的直径至少等于锁钉1000外径最大处的直径。以便于压握后的锁钉1000自外管2000远端脱离。外管2000上还设有缝合线出口2300，缝合线入口2200、缝合线出口2300均与锁钉1000的中空内腔1100相连通。以便于缝合线5000近端依次经缝合线入口2200、锁钉1000的近端及缝合线出口2300穿出。可以理解的是，在其它实施例中，缝合线出口2300可以设置在外管2000管体的任意位置，或者设置在手柄3000上，只要缝合线出口2300与锁钉1000的中空内腔1100相连通，即可将缝合线5000的近端自缝合线出口2300穿出。
在进一步的实施例中，外管2000的远端包括保持部2400，保持部2400的直径由近端至远端逐渐减小。保持部2400用于避免锁钉1000在压握前自外管2000远端脱落。将保持部2400的直径由近端至远端逐渐减小设置，有利于外管2000远端进入患者体内及在体内的顺利通过。
请参阅图34a和图34b，在进一步的实施例中，保持部2400包括位于远端的保持部端面2410。保持部2400沿轴向设有与保持部端面2410相贯通的开口2420，开口2420与容腔2100相连通。开口2420即为缝合线入口2200。
在进一步的实施例中，开口2420沿径向设有凸起2430(参阅图33a)，凸起2430与保持部端面2410之间具有预设距离，部分锁钉1000设置在开口2420中，以使凸起2430固定锁钉1000。
请参阅图34a、图34b及图33a和图33b和图29，在进一步的实施例中，锁钉1000的远端设有圆台1200，圆台1200的直径大于锁钉1000的近端部分的直径，且圆台1200设置在开口2420中，凸起2430固定锁钉1000，防止锁钉1000自外管2000远端脱落。圆台1200还可以使锁钉1000的中空内腔1100与锁钉1000远端之间尽量光滑过渡，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。可以理解的是，预设距离至少为圆台1200的厚度，以使圆台1200放置在凸起2430与保持部端面2410之间，有利于稳定锁钉1000。
请参阅图29，在进一步的实施例中，圆台1200包括内侧表面1210，内侧表面1210为弧形曲面。以使缝合线5000能顺滑的穿过锁钉1000，避免锁钉1000切断缝合线5000 或损伤人体组织。
在进一步的实施例中，外管2000及芯轴7000可以由不锈钢、镍钛、纯钛等金属材料加工而成，也可由ABS、PS、PEEK等高分子材料加工而成，二者的材料可以相同也可以不同。优先用不锈钢制成。
在进一步的实施例中，锁钉1000由不锈钢、纯钛、镍钛、钴铬合金等材料制成，优选纯钛、不锈钢。
锁紧装置100在使用时，操作者先将缝合线5000近端依次经过外管2000远端的缝合线入口2200、锁钉1000的远端开口及外管2000远端管体上的缝合线出口2300穿出，然后将缝合线5000固定在束线器4100的缝合线固定部4110上，再根据需要通过调节装置4000调整缝合线5000的长度，当调整完成后，驱动手柄3000的活动部3200向固定部3100运动，从而带动芯轴7000相对外管2000向远端运动，进而使得推杆6200挤压夹头6100，夹头6100的上夹片6110和下夹片6120压握锁钉1000，从而使得锁钉1000变形(参阅图33a和图33b，图33a是未压握前，图33b是压握后)，将穿装在锁钉1000中的缝合线5000与锁钉1000固定在一起。
下面以二尖瓣出现病变为例来说明本发明的锁紧装置100的操作过程。
二尖瓣为左心房(简称：LA)和左心室(简称：LV)之间的单向“阀门”，可以保证血液从左心房流向左心室。正常健康的二尖瓣具有多根腱索。二尖瓣的瓣叶分为前叶和后叶，左心室处于舒张状态时，两者处于张开状态，血液从左心房流向左心室；左心室处于收缩状态时，腱索被拉伸，保证瓣叶不会被血流冲到心房侧，前、后叶闭合良好，从而保证血液从左心室经过主动脉瓣(简称：AV)流向主动脉。若二尖瓣出现病变，当左心室处于收缩状态时，二尖瓣不能像正常状态时恢复至关闭状态，血流的冲力会进一步导致瓣叶脱入左心房，造成血液返流。本发明第六实施例提供的可调节的锁紧装置100e用于二尖瓣瓣膜修复的使用过程如下，其中第六实施例可包括上述任一实施例中的锁紧反馈件8000的特征。
第一步：首先向二尖瓣的前叶和后叶分别植入多根带有弹性垫片的缝合线5000(参阅图35)，缝合线5000与瓣叶之间的点接触被转变为弹性垫片与瓣叶之间的面接触，可有效降低瓣叶撕裂的风险。
第二步：在患者体外把两侧瓣叶上的多根缝合线5000均穿入锁紧装置100e的锁钉1000中，并将缝合线5000近端自外管2000远端管体上的缝合线出口2300中穿出(参阅图36)，区分前叶和后叶的缝合线，将两组缝合线5000的近端部分分别在一个束线器4100的绕线轴上缠绕几圈，再将缝合线5000近端固定在弹片4114上，以保持缝合线5000与锁钉1000之间的相对位置(参阅图37)。
第三步：将锁紧装置100e远端经心尖推入心脏，向二尖瓣的瓣叶移动靠近，同时拉动缝合线5000，直至可调节的缝合线锁结装置100b远端到达瓣下预定位置(参阅图37)。
第四步：分别旋转两个调节旋钮4500，带动两个导螺杆4300旋转，进而驱动与导螺杆4300相连的束线器4100在调节轨道4200中沿轴向前后移动，以分别调节与束线器4100 相连的两组缝合线5000的松紧，同时通过超声确定二尖瓣返流最轻的状态，当到达该状态时，停止旋转调节旋钮4500，即可保持两组缝合线5000的松紧状态，即保持二尖瓣的前叶和后叶之间的相对距离。
第五步：参阅图32a、图32b、图33a和图33b和图37，保持手柄3000的固定部3100不动，驱动活动部3200向固定部3100运动，直至活动部3200触发锁紧反馈件8000发出声音反馈，此时芯轴7000和推杆6200相对于外管2000向远端移动，推杆6200的远端持续挤压夹头6100，使得夹头6100的上夹片6110和下夹片6120彼此靠拢，压握位于上夹片6110及下夹片6120之间的锁钉1000，直至锁钉1000变形并将锁钉1000中的缝合线5000固定在锁钉1000中，松开活动部3200，弹性夹头6100自动张开，变形后的锁钉1000自锁紧装置100e的外管2000远端的缝合线入口2200解脱。
第六步：将锁紧装置100e远端撤出患者体外，锁钉1000留在患者体内，将缝合线5000的近端固定在心室壁上，此时锁钉1000将分别穿过前叶和后叶的两组缝合线5000固定在一起(参阅图38)，二尖瓣的前叶和后叶被拉向彼此，完成缘对缘修复，形成双孔化结构。
可以理解的是，其他实施例在操作过程与上述第六实施例相类似，不再重复描述。
请参阅图39，本发明还提供一种心脏瓣膜修复系统10，心脏瓣膜修复系统10包括如上述任一实施例中的锁紧装置100，还包括至少一根缝合线5000，缝合线5000用于植入在心脏瓣膜的瓣叶上。
在进一步的实施例中，心脏瓣膜修复系统10还包括缝合线植入装置400，缝合线植入装置400将缝合线5000植入心脏瓣膜的瓣叶，锁紧装置100将缝合线5000固定在心尖、乳头肌或者心室壁上，以缝合线5000作为人工腱索，形成“腱索修复”。
在其他实施例中，缝合线植入装置400将缝合线5000植入心脏瓣膜的不同瓣叶，锁紧装置100将多根缝合线5000固定在一起，从而将瓣叶拉向彼此，形成“缘对缘修复”。
本发明提供的心脏瓣膜修复系统10可通过锁紧装置100锁紧缝合线5000，还能够通过锁紧装置100中的锁紧反馈件8000来判断是否锁紧，保证缝合线5000的锁紧力度，既能防止缝合线5000未锁紧又能防止被过量锁紧压伤而出现断线失效，从而保证锁结效果，提高手术成功率。
以上对本申请实施例进行了详细介绍，本文中应用了具体个例对本申请的原理及实施例进行了阐述，以上实施例的说明只是用于帮助理解本申请的方法及其核心思想；同时，对于本领的一般技术人员，依据本申请的思想，在具体实施例及应用范围上均会有改变之处，综上所述，本说明书内容不应理解为对本申请的限制。

Claims (26)

  1. 一种具有锁紧反馈的锁紧装置，其特征在于，所述锁紧装置包括：
    锁紧组件，所述锁紧组件用于锁紧目标物件；
    手柄，所述锁紧组件与所述手柄连接，所述手柄包括活动部和固定部，所述活动部相对所述固定部移动以驱动所述锁紧组件锁紧目标物件；
    锁紧反馈件，所述锁紧反馈件活动地设置在所述固定部中，并与所述手柄的活动部配合作用以反馈所述目标物件是否锁紧。
  2. 如权利要求1所述的锁紧装置，其特征在于，所述锁紧反馈件通过外露于所述固定部或者与所述固定部撞击产生声音来反馈目标物件是否锁紧。
  3. 如权利要求1所述的锁紧装置，其特征在于，所述锁紧反馈件包括反馈滑块、支撑件以及连接在所述反馈滑块与所述支撑件之间的弹性件；
    所述反馈滑块在所述活动部的作用下向所述固定部的近端移动，所述支撑件跟随所述反馈滑块移动，所述固定部设有第一槽口，所述支撑件移动至所述第一槽口落入所述第一槽口中时，所述锁紧反馈件外露于所述固定部或者与所述固定部撞击产生声音，以反馈目标物件锁紧。
  4. 如权利要求3所述的锁紧装置，其特征在于，所述固定部中设有第一限位槽和第二限位槽；
    所述反馈滑块在所述活动部的作用下在所述第一限位槽中向所述固定部的近端移动；
    所述支撑件在所述第二限位槽中与所述反馈滑块朝同一方向移动，所述第一槽口与所述第二限位槽连通，所述第一槽口邻近所述固定部的近端设置且贯穿所述固定部的底端方向的外表面，所述支撑件移动至正对所述第一槽口时，在所述弹性件的作用下落入所述第一槽口中。
  5. 如权利要求4所述的锁紧装置，其特征在于，所述锁紧反馈件还包括撞击件，所述弹性件弹性抵推所述撞击件，所述支撑件设置在所述撞击件背离所述弹性件的一侧；当所述支撑件正对所述第一槽口时，所述弹性件推动所述撞击件撞击所述固定部发出声音来反馈目标物件已经锁紧，且所述支撑件落入第一槽口内。
  6. 如权利要求5所述的锁紧装置，其特征在于，所述撞击件的横截面积大于所述第一槽口的横截面积，以使所述支撑件落入所述第一槽口中时，所述撞击件抵顶于所述第一槽口的上方。
  7. 如权利要求6所述的锁紧装置，其特征在于，所述第二限位槽包括第一支撑面，所述支撑件在所述第一支撑面上滑动，所述第一槽口穿通所述第一支撑面；
    所述支撑件落入所述第一槽口中时，所述撞击件定位在所述第一槽口四周的第一支撑面上。
  8. 如权利要求5所述的锁紧装置，其特征在于，所述锁紧反馈件还包括至少一个倒扣，所述倒扣包括第一连接部和卡位部，所述卡位部通过所述第一连接部连接在所述反馈滑块 的下方；
    所述撞击件与所述卡位部在所述反馈滑块上的正投影至少部分重叠；
    所述支撑件落入所述第一槽口中时，所述撞击件抵顶在所述卡位部上。
  9. 如权利要求8所述的锁紧装置，其特征在于，所述倒扣为两个，且设置在所述撞击件相对的两侧，所述支撑件落入所述第一槽口中时，所述撞击件抵顶在两个所述倒扣的卡位部上。
  10. 如权利要求4-9任一项所述的锁紧装置，其特征在于，所述锁紧反馈件还包括反馈按钮，所述反馈按钮包括按钮部和第二连接部，所述按钮部通过所述第二连接部连接所述撞击件，且所述按钮部外露于所述固定部的底端的外表面。
  11. 如权利要求10所述的锁紧装置，其特征在于，所述固定部还包括第二槽口，所述第二槽口沿所述第二限位槽延伸，并贯穿所述第二限位槽及所述固定部的底端的外表面；
    所述第二连接部自所述第二槽口穿出，当所述反馈滑块在所述第一限位槽中滑动时，所述第二连接部在所述第二槽口中移动，以带动外露于所述固定部底端的按钮部移动。
  12. 如权利要求10所述的锁紧装置，其特征在于，当所述支撑件抵顶所述第二限位槽的第一支撑面时，所述按钮部与所述固定部背离所述第二限位槽的外表面的距离小于预设距离。
  13. 如权利要求4-9任一项所述的锁紧装置，其特征在于，所述固定部还包括第三槽口，所述第三槽口的开口方向与所述反馈滑块的移动方向一致，所述活动部通过所述第三槽口推动所述反馈滑块移动。
  14. 如权利要求13所述的锁紧装置，其特征在于，所述活动部对应于所述第三槽口的位置设有凸台；当所述活动部向所述固定部移动时，所述凸台抵接所述反馈滑块并推动所述反馈滑块在第一限位槽中移动。
  15. 如权利要求14所述的锁紧装置，其特征在于，所述凸台包括第一结合部和第二结合部，所述第一结合部与所述第二结合部之间相对伸缩，以调节所述凸台的轴向长度。
  16. 如权利要求15所述的锁紧装置，其特征在于，所述第一结合部与所述第二结合部相对伸缩的方式包括螺纹伸缩或者卡扣伸缩。
  17. 如权利要求16所述的锁紧装置，其特征在于，当采用螺纹伸缩时，所述第一结合部和所述第二结合部分别为螺纹件和螺纹旋盖中的一个，所述螺纹旋盖与所述螺纹件相适配。
  18. 如权利要求13所述的锁紧装置，其特征在于，当所述支撑件位于所述第二限位槽中时，所述反馈滑块自所述第三槽口伸出所述固定部的外表面。
  19. 如权利要求18所述的锁紧装置，其特征在于，所述反馈滑块自所述第三槽口伸出所述固定部的外表面的一端还设有长度可调节的伸缩部。
  20. 如权利要求1-9任一项所述的锁紧装置，其特征在于，所述目标物件包括锁钉和缝合线，所述锁钉用于容置或者固定缝合线，所述锁紧组件用于将所述缝合线锁紧在所述锁钉中；
    所述锁紧组件包括：
    外管，所述外管中设有容腔，所述锁钉设置在所述容腔的远端，所述固定部与所述外管的近端连接；
    调节装置，所述调节装置设于所述固定部上，所述调节装置与所述缝合线近端连接，且用于调节所述缝合线的收紧或者放松。
  21. 如权利要求20所述的锁紧装置，其特征在于，所述调节装置包括束线器和调节轨道，所述调节轨道设置在所述固定部上，所述束线器通过所述调节轨道连接在所述固定部上；
    所述束线器包括相互连接的缝合线固定部和手柄连接部，所述缝合线固定部与所述缝合线之间可拆卸连接，所述手柄连接部设置在所述调节轨道中，所述束线器通过所述手柄连接部在所述调节轨道上沿调节轨道的轴向方向前进或者后退，从而调节所述缝合线的收紧或者放松。
  22. 如权利要求21所述的锁紧装置，其特征在于，所述调节轨道包括轨道腔和轨道外壁，所述手柄连接部包括嵌入端和连接轴，所述嵌入端位于所述轨道腔中且在所述轨道腔中前后移动，所述连接轴位于所述轨道外壁上且在所述轨道外壁上前后移动，所述嵌入端通过所述连接轴与所述缝合线固定部连接。
  23. 如权利要求21所述的锁紧装置，其特征在于，所述调节装置还包括导螺杆、螺栓和调节旋钮，所述导螺杆沿所述调节轨道的轴向方向固定在所述固定部中，所述螺栓固定在所述固定部中，且所述导螺杆穿过所述螺栓并与所述螺栓相适配；
    所述导螺杆的近端穿出所述固定部的近端并与所述调节旋钮相连接；所述手柄连接部固定在所述导螺杆上；所述调节旋钮调节所述导螺杆沿轴向前进或者后退。
  24. 一种心脏瓣膜修复系统，其特征在于，所述心脏瓣膜修复系统包括如权利要求1-23任一项所述的锁紧装置，还包括至少一根缝合线，所述缝合线用于植入在心脏瓣膜的瓣叶上。
  25. 如权利要求24所述的心脏瓣膜修复系统，其特征在于，所述心脏瓣膜修复系统还包括缝合线植入装置，所述缝合线植入装置将所述缝合线植入心脏瓣膜的不同瓣叶，所述锁紧装置将多根所述缝合线固定在一起。
  26. 如权利要求24所述的心脏瓣膜修复系统，其特征在于，所述心脏瓣膜修复系统还包括缝合线植入装置，所述缝合线植入装置将所述缝合线植入心脏瓣膜的瓣叶，所述锁紧装置将所述缝合线固定在心尖、乳头肌或者心室壁上。
PCT/CN2019/097747 2018-12-26 2019-07-25 具有锁紧反馈的锁紧装置及心脏瓣膜修复系统 WO2020134060A1 (zh)

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