WO2019114448A1 - 一种可多次调节的人工腱索固定组件及其介入方法 - Google Patents

一种可多次调节的人工腱索固定组件及其介入方法 Download PDF

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Publication number
WO2019114448A1
WO2019114448A1 PCT/CN2018/113008 CN2018113008W WO2019114448A1 WO 2019114448 A1 WO2019114448 A1 WO 2019114448A1 CN 2018113008 W CN2018113008 W CN 2018113008W WO 2019114448 A1 WO2019114448 A1 WO 2019114448A1
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Prior art keywords
occluder
artificial
switch
adjusting rod
adjusting device
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PCT/CN2018/113008
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English (en)
French (fr)
Inventor
谭雄进
Original Assignee
谭雄进
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Publication date
Application filed by 谭雄进 filed Critical 谭雄进
Priority to EP18888339.1A priority Critical patent/EP3721811B1/en
Priority to US16/649,147 priority patent/US11331188B2/en
Publication of WO2019114448A1 publication Critical patent/WO2019114448A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—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
    • 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
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00601—Implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
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    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • 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
    • A61B2017/0409—Instruments for applying 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0419—H-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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0448—Additional elements on or within the anchor
    • A61B2017/0451—Cams or wedges holding the suture by friction
    • 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
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped

Definitions

  • the invention belongs to the field of biomedical devices, and particularly relates to a manual chordae fixation assembly that can be adjusted multiple times and an intervention method thereof.
  • Mitral regurgitation is one of the most common valvular lesions today, mainly due to mitral annulus dilatation, chord dysfunction, mitral mucus degeneration, valve leaf prolapse, rheumatic valvular disease, ischemic disease Wait. Mitral valvuloplasty and prosthetic valve replacement are the most effective methods for the treatment of mitral regurgitation, but because the surgery requires extracorporeal circulation technical support, the trauma caused by the human body is relatively large, and there are more mergers for older patients. Patients with high levels of complications and mortality.
  • MitraClip percutaneous mitral valve repair techniques, including interventional treatment methods such as annuloplasty, vacuum suction and suture technique, and mitral valve clamp (MitraClip).
  • interventional treatment methods such as annuloplasty, vacuum suction and suture technique, and mitral valve clamp (MitraClip).
  • MitraClip is the most reliable.
  • the MitraClip delivers an implantable clip to the vicinity of the mitral valve through atrial septal puncture, clamping the free edge of the anterior and posterior leaflets, allowing the leaflets to fit well at the end of the systole, reducing backflow, but such instruments cannot Implantation of the chordae is a non-physiological repair.
  • the present invention secures the artificial chordae to the interventricular septum by means of an occluder, providing a fixation assembly that can repeatedly accommodate the length of the artificial chordae.
  • the utility model relates to a manually adjustable chord fixing assembly, which comprises an occluder and an adjusting rod.
  • the occluder is divided into three structures: a first umbrella disk, a waist and a second umbrella disk, and the occluder is first.
  • a middle portion of the umbrella disk, the waist portion and the second umbrella disk is provided with a through passage for the artificial cable to pass therethrough, and a switch adjusting device is disposed at the first umbrella disk through the passage opening, and the outer protruding portion of the switch adjusting device Disposed outside the first umbrella disk, the inner valve and the friction plate extend into the through-channel port, the friction plate is connected with the valve, the number of the friction plates is at least two, and the valve is rotated to control the friction plate Opening and closing, thereby controlling a switch that penetrates the passage, and the occluder is an elastic mesh structure capable of elastic deformation;
  • the adjusting rod is a hollow rod-shaped structure for the artificial sling to pass therethrough, and two clamping jaws are arranged at the head of the adjusting rod, the two clamping jaws are connected to the tail handle of the adjusting rod by a spring, and the clamping jaw is controlled by pressing the tail handle Opening and closing, the jaws can be clamped to the protrusion of the switch adjusting device and connected to the occluder.
  • a convex portion is disposed inside the adjusting rod clamp, and a protrusion is provided at a protruding portion of the switch adjusting device, and the protruding portion is connected when the adjusting rod is connected to the occluder
  • the grooves are combined with each other.
  • the protrusions in the jaws and the grooves of the switch adjusting device are respectively provided with magnets of different polarities, and the magnetic attraction of the protrusions and the grooves is tightly clamped by the adjusting rod jaws in the occluder switch Adjusting the protrusion of the device.
  • valve of the switch adjusting device is a threaded sleeve structure of a valve inner core and a knob, and the valve inner core is connected to the friction plate, and a thread is arranged outside the inner core of the valve, and a screw thread is arranged on the inner side of the knob, and the switch is closed.
  • the knob is tightened inward, and the gap between the friction plates is closed.
  • the switch adjusting device is opened, the knob is loosened, the inner core of the valve is restored, and the gap between the friction plates is opened.
  • the occluder is woven from a nickel-titanium alloy wire having a waist diameter of 3 to 10 mm and a waist height of 2 to 20 mm, and the first and second occluder umbrella disks have a diameter of 7 to 28 mm.
  • the waist has a diameter of 6 mm and a waist height of 8 mm
  • the first and second occluder umbrella disks have a diameter of 10 mm.
  • An intervention method for a manual chord fixation assembly includes the following steps:
  • Step 1 The puncture sheath is passed through the interventricular septum, and the artificial tendon is placed through the interventricular septal perforation to the free edge of the mitral valve, and the tail of the artificial tendon is pulled out of the body through the tail of the puncture sheath;
  • Step 2 connecting the adjusting rod to the switch adjusting device of the occluder, rotating the adjusting rod to open the friction plate of the switch adjusting device, and inserting the artificial chord into the occluder and the adjusting rod with the pulling pin, Entering from the through passage on the side of the second canopy, pulling out from the tail of the adjustment rod;
  • Step 3 Send the occluder and the adjusting rod along the puncture sheath tube, release the second umbrella disc of the occluder on the left ventricle side of the interventricular septum, and place the waist of the occluder in the interventricular septum puncture hole, and the occluder An umbrella disk is released on the right ventricular side of the interventricular septum, the occluder is clamped on the interventricular space, the artificial chord outside the tail of the adjustment rod is pushed and pulled, the length of the artificial chord is adjusted, the friction plate of the switch adjusting device is closed, and the artificial raft is fixed.
  • Step 4 Press the tail handle, open the adjustment head head jaws, release the occluder, exit the adjustment rod, and leave the artificial chordae outside the sheath of the jugular vein puncture;
  • Step 5 Send the thread cutter along the tail of the artificial cable. After reaching the occluder, pull the handle of the tail of the thread cutter, cut the artificial chord, exit the thread cutter, and press to stop the bleeding.
  • step 4a may be further included between step 4 and step 5: when the length of the artificial chord is inappropriate due to factors such as volume change, detachment from anesthesia, etc., the artificial chord is re-inserted into the adjustment rod, along the The artificial chord sends the adjusting rod to the outside of the first damper of the occluder, presses the tail handle, and clamps the clamping jaw of the adjusting rod outside the protruding portion of the switch adjusting device with the help of the chord and the magnetic force, and connects After firming, rotate the switch adjustment device to open the gap between the friction plates, release the manual cable, re-adjust the length of the artificial cable, then rotate the adjustment lever, close the friction plate of the switch adjustment device, fix the artificial cable, and adjust the lever The occluder is separated and withdrawn from the body.
  • the thread cutter is a rod-shaped structure, and the two ends are respectively a trimming end and a handle end, and a groove is arranged at the trimming end, and a blade capable of moving up and down along the groove opening is provided at the handle end.
  • Button the push button is connected to the blade inside the thread cutter, and the blade is controlled to move by the push button.
  • the present invention has the following beneficial effects:
  • the artificial chordae fixation assembly of the present invention fixes the artificial chordae to the interventricular septum by an occluder, which not only closes the defect left by the puncture sheath, but also fixes the artificial chordae.
  • the artificial chordae fixation assembly of the present invention controls the occluder switch through the opening adjustment device on the occluder, and can effectively fix the artificial chord when closed, and can move the artificial chord in the occluder when opening, facilitating mediation Artificial chord length.
  • the artificial chordae fixation assembly of the present invention can overcome the problem that the cardiac length of the majority of patients after surgery causes the length of the artificial chordae is unsuitable, and the artificial chordae is retained at the skin puncture point for a short period of time, and the components of the present invention are used again in the early postoperative period. According to the patient's heart changes, the length of the artificial chordae is adjusted to realize the function of repeatedly adjusting the artificial chordae.
  • the artificial chord fixation assembly of the present invention can increase the clamping force by adjusting the interaction between the protrusion of the jaw on the adjusting rod and the groove of the outer side of the occluder switch adjusting device, and the convex portion and the groove are provided with opposite polarities.
  • the magnet facilitates the connection of the occluder quickly when the adjustment rod is re-entered into the body, improving the efficiency of the operation.
  • Figure 1 is a schematic structural view of an occluder of the present invention
  • FIG. 2 is a schematic structural view of an adjusting rod of the present invention
  • Figure 3 is a schematic structural view of the adjusting rod connecting occluder of the present invention.
  • Figure 4 is a flow chart of the artificial chord fixation assembly of the present invention.
  • Figure 5 is a schematic structural view of the thread cutter of the present invention.
  • Figure 6 is a schematic view showing the structure of a lead pin of the present invention.
  • 1-blocker 11-first umbrella disk, 12-waist, 13-second umbrella disk, 2-switch control device, 21-protrusion, 211-protrusion groove, 22-valve, 23- Friction plate, 3-adjustment lever, 31-claw, 311-claw boss, 32-handle, 4-wire cutter, 41-blade, 42-push button, 5-lead pin
  • the present invention provides a manually adjustable chord fixation assembly that includes multiple adjustments, including an occluder 1 and an adjustment rod 3.
  • the occluder is divided into three structures: a first umbrella disk 11, a waist portion 12 and a second umbrella disk 13.
  • the middle portion of the first umbrella disk, the waist portion and the second umbrella disk of the occluder is provided with a through passage for the artificial sling to pass through.
  • the occluder is an elastic mesh structure and can be elastically deformed. The occluder can be compressed and tightened in the puncture sheath tube.
  • the waist of the occluder fills the perforation gap of the compartment, and the first and second umbrella discs are from the left and right sides. Tightening in the middle, the clamping is fixed on the interventricular septum.
  • the occluder is woven from nickel-titanium alloy wire, the waist diameter CD is 3-10 mm, preferably 6 mm, the waist height CE is 2-20 mm, preferably 8 mm, the first occluder umbrella disc diameter AB, the second plugging
  • the umbrella disk GH has a diameter of 7 to 28 mm, preferably 10 mm.
  • a switch adjusting device 2 is disposed at the opening of the first umbrella disk.
  • the outer protruding portion 21 of the switch adjusting device is disposed outside the first umbrella disk, and the inner valve 22 and the friction plate 23 extend into the through-channel opening, and the friction The piece is connected with the valve, and the rotary valve controls the opening and closing of the friction plate, thereby controlling the switch of the first umbrella plate through the passage.
  • the artificial cable can be clamped to prevent the movement of the artificial cable.
  • the number of the friction plates is at least two, and the number of the friction plates is not limited in the present invention. According to the need of different clamping forces for the artificial chord, the number of the friction plates can be more, for example, five, and the friction plates form a "petal" after being closed. Type, enhance the clamping force of the artificial chord.
  • the adjusting rod 3 is a hollow rod-shaped structure for the artificial cable to pass therethrough, and two clamping jaws 31 are arranged on the adjusting rod head.
  • the two clamping jaws are connected to the adjusting rod tail handle 32 through the spring piece, and are controlled by pressing the tail handle.
  • the jaws are opened and closed, and the jaws can be clamped on the protrusion of the switch adjusting device to be connected with the occluder.
  • the valve of the switch adjusting device of the present invention is a threaded sleeve structure of the inner core of the valve and the knob.
  • the inner core of the valve is connected with the friction plate, and the outer core of the valve is provided with a thread, and the inner side of the knob is provided with a thread, and the switch is closed.
  • the knob is tightened inward, and the gap between the friction plates is closed.
  • the switch adjusting device is opened, the knob is loosened, the inner core of the valve is restored, and the gap between the friction plates is opened.
  • the valve knob of the switch adjusting device is rotated by rotating the adjusting rod, and the clock knob is rotated clockwise to screw the valve knob into the inner core of the occluder, the inner core is tightened, the friction plate is closed, and the artificial chord is clamped.
  • the inner core restores the shape, and the friction plates that are closed to each other loosen to form a gap, and the artificial chord can move in the gap.
  • a convex portion 311 is disposed inside the adjusting rod clamp, and a groove 211 is provided at a protruding portion of the switch adjusting device, and the convex portion and the concave portion are connected when the adjusting rod is connected with the occluder
  • the grooves are combined with each other to increase the bonding force of the connection.
  • the magnets of different polarities are respectively disposed on the protrusions in the jaws and the grooves of the switch adjusting device, and the magnetic rods of the protrusions and the grooves are tightly clamped by the adjusting rods in the occluder On the protrusion of the switch adjusting device.
  • the occluder is fixed at the interventricular septum to complete the initial fixation of the artificial chord.
  • the adjustment rod needs to be connected again to the switch control device of the occluder, and the magnetic attraction of the convex portion and the groove is attracted.
  • the adjustment rod can be quickly connected to the occluder, which saves the time for the doctor to find the connection point during the operation, and facilitates repeated adjustment of the artificial chord.
  • FIG. 4 is a flow chart of the artificial chord fixation assembly of the present invention. As shown in FIG. 4, the intervention method of the artificial chord fixation assembly includes the following steps:
  • Step 1 The puncture sheath is passed through the interventricular septum, and the artificial tendon is placed through the interventricular septal perforation to the free edge of the mitral valve, and the tail of the artificial tendon is pulled out of the body through the tail of the puncture sheath;
  • Step 2 Connect the adjusting rod to the switch adjusting device of the occluder, rotate the adjusting rod to open the friction plate of the switch adjusting device, and use the pulling needle to penetrate the artificial chord into the occluder and the adjusting rod from the second umbrella side
  • the through passage enters and is pulled out from the tail of the adjustment rod;
  • Step 3 Send the occluder and the adjusting rod along the puncture sheath tube, release the second umbrella disc of the occluder on the left ventricle side of the interventricular septum, and place the occluder waist in the interventricular septum perforation, and the occluder first
  • the umbrella disk is released on the right ventricle side of the interventricular septum, the occluder is clamped on the interventricular space, the artificial chord outside the tail of the adjustment rod is pushed and pulled, the length of the artificial chord is adjusted, the friction plate of the switch adjusting device is closed, and the artificial chord is fixed;
  • Step 4 Press the tail handle, open the adjustment head head jaws, release the occluder, exit the adjustment rod, and leave the artificial chordae outside the sheath of the jugular vein puncture;
  • Step 5 Send the thread cutter along the tail of the artificial cable. After reaching the occluder, pull the handle of the tail of the thread cutter, cut the artificial chord, exit the thread cutter, and press to stop the bleeding.
  • step 4 a may be included between step 4 and step 5: when the length of the artificial chord is inappropriate due to factors such as volume change, detachment from anesthesia, etc., the artificial chord is inserted into the adjustment rod, along the artificial The chord sends the adjusting rod to the outside of the first damper of the occluder, presses the tail handle, clamps the clamping jaw of the adjusting rod outside the protruding portion of the switch adjusting device, and rotates the adjusting device to open the gap between the two friction plates. Loosen the artificial chord, re-adjust the length of the artificial chord, then rotate the adjusting rod, close the friction plate of the adjusting device, fix the artificial chord, separate the adjusting rod from the occluder, and withdraw it from the body.
  • the structure of the thread is as shown in FIG. 6, and the lead 5 is the rod.
  • the elastic structure has a curved elastic hook at the head of the lead.
  • the elastic hook head is engaged with the rod body.
  • the elastic hook is forced to open.
  • the artificial chord enters the inside of the elastic hook, and then the elastic hook head and the rod are restored to fit, and the artificial chord is placed inside the elastic hook to hook the upper end of the artificial chord.
  • the invention also provides a thread cutter, as shown in FIG. 5, in step 5, the thread cutter is fed into the thread cutter through the puncture sheath along the tail of the artificial cable, and the thread cutter 4 is a rod-shaped structure, and the two ends are respectively
  • the trimming end and the handle end are provided with a groove at the trimming end, and a blade 41 which can move up and down along the groove opening, and a push button 42 is arranged at the handle end, and the push button is connected to the blade inside the thread trimmer, and is pushed through The button controls the blade movement.
  • the assembly of the invention can not only fix the artificial chordae on the interventricular septum, but also overcome the problem that the cardiac changes of most patients lead to the unsuitable length of the artificial chordae, and the components of the invention are temporarily retained for artificial choking in the skin puncture.
  • the length of the artificial chordae is adjusted according to the heart changes of the patient in the early postoperative period, and the function of repeatedly arranging the artificial chordae is realized.

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Abstract

一种可多次调节的人工腱索固定组件及其介入方法，固定组件包括封堵器(1)以及调节杆(3)，均为中空结构供人工腱索穿过其中，封堵器(1)用于夹持在室间隔，封堵器(1)上设有开关调节装置(2)，控制人工腱索的移动和固定，调节杆(3)与封堵器(1)连接，可以多次调节封堵器(1)上的开关调节装置(2)。固定组件不但能将人工腱索铆定在室间隔上，还能够克服多数患者术后因心脏变化导致人工腱索长度不适宜的问题，将人工腱索通过固定组件短期保留在皮肤穿刺点处，在术后早期可以再次根据患者心脏变化调节人工腱索长度，实现反复调解人工腱索的功能。

Description

一种可多次调节的人工腱索固定组件及其介入方法 技术领域
本发明属于生物医学器械领域，具体涉及一种可多次调节的人工腱索固定组件及其介入方法。
背景技术
二尖瓣关闭不全是当今最常见的瓣膜病变之一，主要原因有二尖瓣环扩张、腱索功能不全、二尖瓣粘液变性、瓣叶脱垂、风湿性心瓣膜病、缺血性病变等。二尖瓣直视成形术及人工瓣膜置换术是治疗二尖瓣关闭不全的最有效方法，但是由于手术需要体外循环技术支持，给人体带来的创伤比较大，对高龄患者和有较多合并症患者，有相当高的并发症和死亡率。
因此，近年各国的医务人员和科研人员进行了经皮二尖瓣修复技术的探索，主要有介入治疗方式有瓣环成形术、负压抽吸缝合技术及二尖瓣钳夹术(MitraClip)等，其中以MitraClip疗效最为可靠。MitraClip通过房间隔穿刺将一个可植入的夹子送至二尖瓣附近，将前后瓣叶的游离缘进行钳夹固定，使瓣叶在收缩末期对合良好，减少返流，但这类器械无法植入腱索，是非生理性修复。
通过在瓣叶上植入人工腱索是接近生理状态的修复方法，通常经经心尖进行手术，创伤大，风险高，如果能经皮治疗就能带来更安全的微创效果，但是经皮途径下如何固定人工腱索是亟待解决的问题。此外人工腱索一旦固定后不能再次调解腱索长度，患者心脏随容量等因素变化及脱离麻醉状态后，人工腱索长度需要随之调整，否则会出现心脏瓣膜功能异常的情况，导致手术失败。
发明内容
为了克服上述问题，本发明通过封堵器将人工腱索固定在室间隔上，提供了一种能够重复调解人工腱索长度的固定组件。
本发明提供以下技术方案：
一种可多次调节的人工腱索固定组件，包括封堵器以及调节杆，所述封堵器分为第一伞盘、腰部和第二伞盘三个结构，所述封堵器第一伞盘、腰部及第二伞盘的中部设有贯穿通道，供人工腱索穿过其间，在所述第一伞盘贯穿通道口处设有开关调节装置，所述开关调节装置的外侧突出部设置在第一伞盘外，内侧的阀门和摩擦片伸入到贯穿通道口之中，所述摩擦片与阀门相连接，摩擦片的数量至少为两片，旋转所述阀门控制所述摩擦片的开合，从而控制贯穿通道的开关，所述封堵器为弹性网状结构，能够发生弹性形变；
所述调节杆为中空杆状结构，供人工腱索穿过其间，在调节杆头部设有两个夹爪，两个夹爪通过弹簧连接在调节杆尾部手柄，通过按压尾部手柄控制夹爪开合，所述夹爪能够夹持在所述开关调节装置的突出部上与所述封堵器相连接。
进一步地，在所述调节杆夹爪内侧设有凸起部，在所述开关调节装置的突出部设有凹槽，当调节杆连接所述封堵器连接时，所述凸起部与所述凹槽相互结合。
进一步地，所述夹爪内的凸起部以及开关调节装置凹槽分别设有不同极性的磁铁，通过凸起部和凹槽的磁性吸引，调节杆夹爪紧密夹持在封堵器开关调节装置的突出部上。
进一步地，所述开关调节装置的阀门为阀门内芯和旋钮的螺纹套接结构，所述阀门内芯连接所述摩擦片，阀门内芯外侧设有螺纹，旋钮内侧设有螺纹，关闭开关调节装置时，旋紧旋钮，阀门内芯向内收紧，摩擦片之间的缝隙关闭；打开开关调节装置时，旋松旋钮，阀门内芯恢复形状，摩擦片之间的缝隙打开。
进一步地，所述封堵器由镍钛合金丝编织而成，所述腰部直径为 3～10mm，腰部高度为2～20mm，第一、第二封堵器伞盘的直径为7～28mm。
进一步地，所述腰部直径为6mm，腰部高度为8mm，第一、第二封堵器伞盘直径为10mm。
一种人工腱索固定组件的介入方法，包括以下步骤：
步骤一 穿刺鞘管穿过室间隔，通过室间隔穿孔处置入人工腱索于病变二尖瓣游离缘后，将人工腱索尾部经穿刺鞘管尾部拉出体外；
步骤二 将调节杆与所述封堵器的开关调节装置相连接，旋转调节杆打开所述开关调节装置的摩擦片，用牵引针将人工腱索穿入所述封堵器及调节杆内，从第二伞盘侧的贯穿通道进入，从调节杆尾部拉出；
步骤三 沿穿刺鞘管送入封堵器和调节杆，将封堵器第二伞盘释放在室间隔的左心室侧，将封堵器腰部置于室间隔穿刺孔内，将封堵器第一伞盘释放在室间隔右心室侧，封堵器夹持在室间隔上，推拉调节杆尾部外侧的人工腱索，调节人工腱索长度，关闭所述开关调节装置的摩擦片，固定人工腱索；
步骤四 按压尾部手柄，打开调节杆头部夹爪，释放封堵器，退出调节杆，将人工腱索留置于颈静脉穿刺处的鞘管外；
步骤五 沿人工腱索尾部送入剪线器，到达封堵器后，扳动剪线器尾部的手柄，剪断人工腱索，退出剪线器，压迫止血。
进一步地，在步骤四和步骤五之间还可以包括步骤四a：当心脏因容量变化、脱离麻醉状态等因素造成人工腱索长度不合适时，将人工腱索重新穿入调节杆内，沿人工腱索将调节杆送入至封堵器第一伞盘外侧，按压尾部手柄，在腱索及磁性的帮助下，将调节杆的夹爪夹持在所述开关调节装置突出部外侧，连接牢固后，旋转开关调节装置，使摩擦片打开间隙，松开人工腱索，重新调整人工腱索的长度，再旋转调节杆，关闭开关调节装置的摩擦片，固定人工腱索，将调节杆与 封堵器分离，撤出体外。
进一步地，所述剪线器为杆状结构，两端分别为剪线端和手柄端，在剪线端设有凹槽，及能够沿凹槽口上下移动的刀片，在手柄端设有推钮，所述推钮在剪线器内部与刀片相连，通过推钮控制刀片移动。
采用上述技术方案，本发明具有如下有益效果：
1、本发明的人工腱索固定组件将人工腱索通过封堵器固定在室间隔上，不但可以封闭穿刺鞘留下的缺损，而且可以固定人工腱索。
2、本发明人工腱索固定组件通过封堵器上的开口调节装置控制封堵器的开关，关闭时能够有效固定人工腱索，打开时能够使人工腱索在封堵器內移动，便于调解人工腱索长度。
3、本发明人工腱索固定组件能够克服多数患者术术后的心脏变化导致人工腱索长度不适宜的问题，短期保留人工腱索在皮肤穿刺点处，在术后早期利用本发明的组件再次根据患者心脏变化调节人工腱索长度，实现反复调节人工腱索的功能。
4、本发明人工腱索固定组件通过调节杆上的夹爪凸起部与封堵器开关调节装置外侧凹槽的相互配合能够增加夹持力度，并且凸起部和凹槽设有极性相反的磁铁便于调节杆再次进入体内时，快速与封堵器连接，提高手术效率。
附图说明
图1是本发明封堵器的结构示意图；
图2是本发明调节杆的结构示意图；
图3是本发明调节杆连接封堵器的结构示意图；
图4是介入本发明人工腱索固定组件的流程图；
图5是本发明剪线器的结构示意图；
图6是本发明引线针的结构示意图。
其中，1-封堵器，11-第一伞盘，12-腰部，13-第二伞盘，2-开关控制装置，21-突出部，211-突出部凹槽，22-阀门，23-摩擦片，3-调节杆，31-夹爪，311-夹爪凸起部，32-手柄，4-剪线器，41-刀片，42-推钮，5-引线针
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，下面结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的结构图及具体实施例仅用以解释本发明，并不用于限定本发明。
实施例1
如图1、2所示，本发明提供了一种可多次调节的人工腱索固定组件，包括封堵器1以及调节杆3。封堵器分为第一伞盘11、腰部12和第二伞盘13三个结构，封堵器第一伞盘、腰部及第二伞盘的中部设有贯穿通道，供人工腱索穿过其间，封堵器为弹性网状结构，能够发生弹性形变。封堵器能够压缩收紧在穿刺鞘管内，当封堵器释放在室间隔的穿孔缺口处时，封堵器的腰部填满室间隔的穿孔缺口，第一、第二伞盘从左右两侧向中间收紧，夹持固定在室间隔上。
封堵器由镍钛合金丝编织而成，腰部直径CD为3～10mm，优选为6mm，腰部高度CE为2～20mm，优选为8mm，第一封堵器伞盘直径AB、第二封堵器伞盘GH直径为7～28mm，优选为10mm。
在第一伞盘贯穿通道口处设有开关调节装置2，开关调节装置的外侧突出部21设置在第一伞盘外，内侧的阀门22和摩擦片23伸入到贯穿通道口之中，摩擦片与阀门相连接，旋转阀门控制摩擦片的开合，从而控制第一伞盘贯穿通道的开关，摩擦片闭合后能够夹持住人工腱索，阻止人工腱索的移动。摩擦片的数量至少为两个，本发明并未限定摩擦片的数量，根据对人工腱索不同夹持力的需要，摩擦片数量可以更多，例如5个，摩擦片闭合后形成“花瓣”型，增强对人工腱索的夹持力。
调节杆3为中空杆状结构，供人工腱索穿过其间，在调节杆头部设有两个夹爪31，两个夹爪通过弹簧片连接在调节杆尾部手柄32，通过按压尾部手柄控制夹爪开合，夹爪能够夹持在开关调节装置的突出部上与封堵器相连接。
本发明的开关调节装置的阀门为阀门内芯和旋钮的螺纹套接结构，如图1所示，阀门内芯连接摩擦片，阀门内芯外侧设有螺纹，旋钮内侧设有螺纹，关闭开关调节装置时，旋紧旋钮，阀门内芯向内收紧，摩擦片之间的缝隙关闭；打开开关调节装置时，旋松旋钮，阀门内芯恢复形状，摩擦片之间的缝隙打开。
调节杆连接封堵器后，通过旋转调节杆动带动开关调节装置的阀门旋钮旋转，顺时针旋转使阀门旋钮旋进封堵器内芯，内芯收紧，摩擦片关闭，夹住人工腱索，使其不能移动；逆时针旋转调节杆旋钮向外旋出，内芯恢复形状，相互关闭的的摩擦片松开形成间隙，人工腱索能够在间隙中移动。
实施例2
优选地，如图3所示，在调节杆夹爪内侧设有凸起部311，在开关调节装置的突出部设有凹槽211，当调节杆连接封堵器连接时，凸起部与凹槽相互结合，增加连接的结合力。
更加优选地，在夹爪内的凸起部以及开关调节装置凹槽上分别设有不同极性的磁铁，通过凸起部和凹槽的磁性吸引，调节杆夹爪紧密夹持在封堵器开关调节装置的突出部上。封堵器固定在室间隔完成人工腱索的初步固定，当需要再次调整人工腱索长度时，需要将调节杆再次连接在封堵器的开关控制装置上，凸起部和凹槽上磁性吸引能够使调节杆快速地连接在封堵器上，节省手术中医生寻找连接点的时间，便于人工腱索的反复调节。
实施例3
图4是介入本发明人工腱索固定组件的流程图，如图4所示，人 工腱索固定组件的介入方法，包括以下步骤：
步骤一 穿刺鞘管穿过室间隔，通过室间隔穿孔处置入人工腱索于病变二尖瓣游离缘后，将人工腱索尾部经穿刺鞘管尾部拉出体外；
步骤二 将调节杆与封堵器的开关调节装置相连接，旋转调节杆打开开关调节装置的摩擦片，用牵引针将人工腱索穿入封堵器及调节杆内，从第二伞盘侧的贯穿通道进入，从调节杆尾部拉出；
步骤三 沿穿刺鞘管送入封堵器和调节杆，将封堵器第二伞盘释放在室间隔的左心室侧，将封堵器腰部置于室间隔穿孔内，将封堵器第一伞盘释放在室间隔右心室侧，封堵器夹持在室间隔上，推拉调节杆尾部外侧的人工腱索，调节人工腱索长度，关闭开关调节装置的摩擦片，固定人工腱索；
步骤四 按压尾部手柄，打开调节杆头部夹爪，释放封堵器，退出调节杆，将人工腱索留置于颈静脉穿刺处的鞘管外；
步骤五 沿人工腱索尾部送入剪线器，到达封堵器后扳动剪线器尾部的手柄，剪断人工腱索，退出剪线器，压迫止血。
优选地，在步骤四和步骤五之间还可以包括步骤四a：当心脏因容量变化、脱离麻醉状态等因素造成人工腱索长度不合适时，将人工腱索穿入调节杆内，沿人工腱索将调节杆送入至封堵器第一伞盘外侧，按压尾部手柄，将调节杆的夹爪夹持在开关调节装置突出部外侧，旋转开关调节装置，使两个摩擦片打开间隙，松开人工腱索，重新调整人工腱索的长度，再旋转调节杆，关闭调节装置的摩擦片，固定人工腱索，将调节杆与封堵器分离，撤出体外。
在步骤一中，当人工腱索尾部拉出体外后，用引线器钩住人工腱索，便于将人工腱索穿入固定组件内，将线器结构如图6所示，引线器5为杆状结构，在引线器头部有弯曲的弹性钩，所述弹性钩未受力的情况下，弹性钩头部与杆体贴合，当人工腱索通过弹性钩头部时，弹性钩受力打开，供人工腱索进入弹性钩内部，然后弹性钩头部与杆 体恢复贴合，将人工腱索置于弹性钩之内，从而钩住住人工腱索的上端。
本发明还提供了一种剪线器，如图5所示，在步骤五中，通过穿刺鞘管沿人工腱索尾部送入剪线器，剪线器4为杆状结构，两端分别为剪线端和手柄端，在剪线端设有凹槽，及能够沿凹槽口上下移动的刀片41，在手柄端设有推钮42，推钮在剪线器内部与刀片相连，通过推钮控制刀片移动。
本发明的组件不但能将人工腱索铆定在室间隔上，还能够克服多数患者术后的心脏变化导致人工腱索长度不适宜的问题，将本发明的组件短期保留人工腱索在皮肤穿刺点处，在术后早期再次根据患者心脏变化调节人工腱索长度，实现反复调解人工腱索的功能。
以上所述实施例仅表达了本发明的实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (9)

  1. 一种可多次调节的人工腱索固定组件，包括封堵器以及调节杆，其特征在于，所述封堵器分为第一伞盘、腰部和第二伞盘三个结构，所述封堵器第一伞盘、腰部及第二伞盘的中部设有贯穿通道，供人工腱索穿过其间，在所述第一伞盘贯穿通道口处设有开关调节装置，所述开关调节装置的外侧突出部设置在第一伞盘外，内侧的阀门和摩擦片伸入到贯穿通道口之中，所述摩擦片与阀门相连接，摩擦片的数量至少为两片，旋转所述阀门控制所述摩擦片的开合，从而控制第一伞盘贯穿通道的开关，所述封堵器为弹性网状结构，能够发生弹性形变；
    所述调节杆为中空杆状结构，供人工腱索穿过其间，在调节杆头部设有两个夹爪，两个夹爪通过弹簧连接在调节杆尾部手柄，通过按压尾部手柄控制夹爪开合，所述夹爪能够夹持在所述开关调节装置的突出部上与所述封堵器相连接。
  2. 根据权利要求1所述的人工腱索固定组件，其特征在于，在所述调节杆夹爪内侧设有凸起部，在所述开关调节装置的突出部设有凹槽，当调节杆连接所述封堵器连接时，所述凸起部与所述凹槽相互结合。
  3. 根据权利要求2所述的人工腱索固定组件，其特征在于，所述夹爪内的凸起部以及开关调节装置凹槽分别设有不同极性的磁铁，通过凸起部和凹槽的磁性吸引，调节杆夹爪紧密夹持在封堵器开关调节装置的突出部上。
  4. 根据权利要求1所述人工腱索固定组件，其特征在于，所述开关调节装置的阀门为阀门内芯和旋钮的螺纹套接结构，所述阀门内芯连接所述摩擦片，阀门内芯外侧设有螺纹，旋钮内侧设有螺纹，关闭开关调节装置时，旋紧旋钮，阀门内芯向内收紧，摩擦片之间的缝隙关闭；打开开关调节装置时，旋松旋钮，阀门内芯恢复形状，摩擦片之间的缝隙打开。
  5. 根据权利要求1所述的人工腱索固定组件，其特征在于，所述封堵器由镍钛合金丝编织而成，所述腰部直径为3～10mm，腰部高度为2～20mm，第一、第二封堵器伞盘的直径为7～28mm。
  6. 根据权利要求5所述的人工腱索固定组件，其特征在于，所述腰部直径为6mm，腰部高度为8mm，第一、第二封堵器伞盘直径为10mm。
  7. 权利要求1、2、3中任一项所述的人工腱索固定组件的介入方法，其特征在于，包括以下步骤：
    步骤一 穿刺鞘管穿过室间隔，通过室间隔穿孔处置入人工腱索于病变二尖瓣游离缘后，将人工腱索尾部经穿刺鞘管尾部拉出体外；
    步骤二 将调节杆与所述封堵器的开关调节装置相连接，旋转调节杆打开所述开关调节装置的摩擦片，用牵引针将人工腱索穿入所述封堵器及调节杆内，从第二伞盘侧的贯穿通道进入，从调节杆尾部拉出；
    步骤三 沿穿刺鞘管送入封堵器和调节杆，将封堵器第二伞盘释放在室间隔的左心室侧，将封堵器腰部置于室间隔穿刺孔内，将封堵器第一伞盘释放在室间隔右心室侧，封堵器夹持在室间隔上，推拉调节杆尾部外侧的人工腱索，调节人工腱索长度，关闭所述开关调节装置的摩擦片，固定人工腱索；
    步骤四 按压尾部手柄，打开调节杆头部夹爪，释放封堵器，退出调节杆，将人工腱索留置于颈静脉穿刺处的鞘管外；
    步骤五 沿人工腱索尾部送入剪线器，到达封堵器后，扳动剪线器尾部的手柄，剪断人工腱索，退出剪线器，压迫止血。
  8. 根据权利要求7所述的人工腱索固定组件的介入方法，其特征在于，在步骤四和步骤五之间还包括步骤四a：当心脏因容量变化、脱离麻醉状态等因素造成人工腱索长度不合适时，将人工腱索重新穿入调节杆内，沿人工腱索将调节杆送入至封堵器第一伞盘外侧，按压尾部手柄，将调节杆的夹爪夹持在所述开关调节装置突出部外侧，连 接牢固后，旋转开关调节装置，使摩擦片打开间隙，松开人工腱索，重新调整人工腱索的长度，再旋转调节杆，关闭开关调节装置的摩擦片，固定人工腱索，将调节杆与封堵器分离，撤出体外。
  9. 根据权利要求7所述的人工腱索固定组件的介入方法，其特征在于，所述剪线器为杆状结构，两端分别为剪线端和手柄端，在剪线端设有凹槽，及能够沿凹槽口上下移动的刀片，在手柄端设有推钮，所述推钮在剪线器内部与刀片相连，通过推钮控制刀片移动。
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