WO2023029724A1 - 经导管缩环系统及其应用 - Google Patents

经导管缩环系统及其应用 Download PDF

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Publication number
WO2023029724A1
WO2023029724A1 PCT/CN2022/103487 CN2022103487W WO2023029724A1 WO 2023029724 A1 WO2023029724 A1 WO 2023029724A1 CN 2022103487 W CN2022103487 W CN 2022103487W WO 2023029724 A1 WO2023029724 A1 WO 2023029724A1
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WO
WIPO (PCT)
Prior art keywords
wire
transcatheter
ring
tightening
anchoring
Prior art date
Application number
PCT/CN2022/103487
Other languages
English (en)
French (fr)
Inventor
张庭超
郭荣辉
Original Assignee
杭州德晋医疗科技有限公司
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Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2023029724A1 publication Critical patent/WO2023029724A1/zh

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Classifications

    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • 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
    • 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
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0012—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting elasticity, flexibility, spring rate or mechanical tension

Definitions

  • the present application relates to the technical field of medical devices, in particular to a transcatheter ring shrinkage system and its application.
  • Mitral regurgitation (abbreviation: MR) is a common heart valve disease, including primary mitral regurgitation and secondary mitral regurgitation.
  • Primary mitral regurgitation is due to abnormal mitral valve leaflets, chordal rupture or papillary muscle insufficiency leading to poor anastomosis of the anterior and posterior leaflets of the mitral valve
  • secondary mitral regurgitation is due to annulus dilatation, left atrium And left ventricular enlargement leads to poor anastomosis of the anterior and posterior mitral valve leaflets.
  • mitral valve interventional therapy has developed rapidly, mainly including valve repair or valve replacement.
  • mitral annuloplasty is a common repair procedure, which reduces mitral regurgitation by reducing the size of the patient's valve annulus.
  • a plurality of anchoring components slidably connected to a rope are sequentially implanted in the annulus of the mitral valve through a transcatheter route, and then the rope is tightened to shrink the annulus, thereby improving mitral valve annulus. valve regurgitation. Since the anchoring components need to be worn on the rope from outside the body, the rope extends from the mitral valve annulus to the outside of the body. , the rope needs to be locked so that the tightened rope is locked on the annulus to maintain a certain length, and then the excess rope is cut. However, cutting of the cord in vivo produces shedding of cord material particles, which can easily cause embolism.
  • the present application aims to provide a transcatheter ring shrinking system and its application to solve the problem that particles on the wire material fall off during cutting the tightening wire in the body, which may easily cause embolism.
  • the present application provides a transcatheter ring shrinkage system, which includes a plurality of anchor components, interconnected tightening wires, and a delivery member.
  • the delivery part is flexible and extends outside the body.
  • the anchor components are transported along the delivery part and put on the tightening wire. After the multiple anchor components are anchored into the heart tissue, the tightening wire adjusts the distance between the multiple anchor components and connects with them. Conveyor separates.
  • the present application also provides an application of the above-mentioned transcatheter ring shrinkage system, which is used to shrink the valve ring during annuloplasty or reduce the volume of the ventricle during ventricular volume reduction .
  • a conveying member that is detachably connected to the tightening wire is provided, and a plurality of anchor components are sequentially threaded onto the tightening wire through the conveying member, so that the tightening wire
  • An appropriate implant length can be selected, so that the tightening wire does not need to be cut in vivo, avoiding the shedding of particles on the wire, and making the operation safer.
  • FIG. 1 is a schematic structural view of a transcatheter ring shrinkage system provided by an embodiment of the present application.
  • Fig. 2 is a schematic diagram of an implant provided in an embodiment of the present application implanted in the valve annulus and the tightening wire is not tightened.
  • Fig. 3 is a schematic diagram of the tightening line in Fig. 2 after being tightened.
  • Fig. 4 is a schematic diagram of the connection of the delivery member, the tightening wire and the first anchoring component provided by an embodiment of the present application.
  • Fig. 5 is a schematic diagram of the connection between the delivery member, the tightening wire and the first anchoring assembly provided by another embodiment of the present application.
  • Fig. 6 is a schematic diagram of the connection between the delivery member, the tightening wire and the first anchoring assembly provided by another embodiment of the present application.
  • Fig. 7 is a schematic diagram of the connection between the tightening wire and the threading structure of the first anchoring component provided in still another embodiment of the present application.
  • Fig. 8 is a schematic structural view of the conveying part and the lead part in Fig. 4 .
  • Fig. 9 is a schematic perspective view of the three-dimensional structure of the anchor assembly provided by an embodiment of the present application.
  • FIG. 10 is a side view of the anchor assembly of FIG. 9 .
  • Fig. 11 is a schematic perspective view of the three-dimensional structure of the anchor seat in Fig. 10 .
  • FIG. 12 is a schematic perspective view of the connecting piece in FIG. 10 .
  • Fig. 13 is a schematic diagram of the connection between the anchor assembly and the anchor device provided by an embodiment of the present application.
  • Fig. 14 is a schematic diagram of separation of the anchoring assembly and the anchoring device in Fig. 13 .
  • Fig. 15 is an axial cross-sectional view of the anchor assembly in Fig. 13 when it is connected to the anchor device.
  • Fig. 16 is a schematic perspective view of the anchor assembly provided in an embodiment of the present application and fitted on the distal end of the delivery sheath.
  • FIG. 17 is an enlarged schematic view of part XVII in FIG. 16 .
  • Fig. 18 is a schematic diagram of a scene where a delivery sheath pushes a spacer.
  • Fig. 19 is a schematic diagram of a pusher pushing a spacer.
  • Fig. 20 is a schematic perspective view of the three-dimensional structure of the conveying element passing through the wire take-up device.
  • Fig. 21 is a perspective view of the structure of the wire retractor in Fig. 20 without the proximal part of the housing.
  • Fig. 22 is a schematic perspective view of the three-dimensional structure of the winding shaft, the limiting post, the anti-rotation wheel and the elastic member.
  • Fig. 23 is an axial sectional view of the connection between the wire take-up and the distal end of the adjustment device.
  • 24 to 27 are schematic diagrams of the use process of the transcatheter ring shrinking system provided by an embodiment of the present application.
  • proximal end means the end far away from the operator during the surgical operation
  • distal end means the end close to the operator during the surgical operation
  • the circumferential direction is the direction around the axis of objects such as cylinders and tubes
  • the radial direction is the direction along the diameter or radius.
  • end is not limited to the end, end point or end face, but also includes the end, end point, or end face at the end, end point, or The portion of the element to which the end face belongs extends an axial distance and/or a radial distance.
  • all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the technical field to which this application belongs.
  • the conventional terms used in the description of the present application are only for the purpose of describing specific implementations, and should not be construed as limiting the present application.
  • the present application provides a transcatheter ring shrinkage system 1, which can be used to implant multiple anchors connected in series by tightening wire 32 in heart tissue such as mitral valve ring or tricuspid valve ring.
  • anchoring components 34 by tightening the tightening wire 32 to narrow the distance between multiple anchoring components 34, so as to directly reduce the valve annulus, so as to realize the treatment of mitral valve regurgitation or tricuspid valve regurgitation.
  • the transcatheter ring shrinkage system 1 may include an anchoring device 10 , an implant 30 , a delivery device 50 and a guiding device 70 .
  • the introducing device 70 includes a first guiding sheath 71 and a second guiding sheath 72 worn in the first guiding sheath 71, the second guiding sheath 72 can protrude from the distal end of the first guiding sheath 71 and fit on the annulus, so as to establish an intervention channel from the outside to the heart.
  • both the first guiding sheath 71 and the second guiding sheath 72 are adjustable curved sheaths, so that the distal end of the guiding device 70 can be adjusted to fit the valve annulus, and the two adjustable curved
  • the guiding sheath can better adjust the bending angle and direction of the distal end of the guiding device 70 .
  • the guiding device 70 may only use an adjustable guiding sheath.
  • the adjustable guiding sheath is a commonly used guiding device in interventional surgery in the prior art, and will not be described in detail here.
  • the implant 30 includes a tightening wire 32 and a plurality of anchoring components 34, and the plurality of anchoring components 34 are connected by the tightening wire 32 and are respectively used for anchoring into the flap. ring.
  • each anchoring component 34 is detachably connected to the distal end of the anchoring device 10 , and the anchoring device 10 is used to anchor the anchoring component 34 into the valve annulus.
  • the delivery device 50 is used to deliver the implant 30 to the annulus.
  • the delivery device 50 includes a delivery member 53 interconnected with the tightening wire 32 , the delivery member 53 is flexible and extends outside the body of the patient.
  • the anchoring assembly 34 is transported along the delivery member 53 and put on the tightening wire 32. After multiple anchoring assemblies 34 are anchored into the valve annulus, the tightening wire 32 adjusts multiple anchoring The components 34 are spaced apart from the conveying member 53 .
  • a plurality of anchor assemblies 34 are connected in series through the tightening wire 32 and anchored into different positions along the circumference of the valve annulus, and the tightening wire 32 narrows the distance between the plurality of anchor assemblies 34, so that the tightening ring can be realized. Purpose.
  • a delivery member 53 detachably connected to the tightening wire 32 is provided, and a plurality of anchor assemblies 34 are sequentially threaded through the delivery member 53 until tightened.
  • the tightening thread 32 can choose a suitable implant length, so that the tightening thread 32 does not need to be cut in vivo, avoiding the shedding of particles on the thread, and the ring reduction operation is safer.
  • the distal end of the tightening wire 32 is connected to the first anchoring component 34 for anchoring into the annulus (see FIGS. 4 to 6 ), and the other anchoring components 34 for anchoring into the annulus are along the
  • the conveying element 53 is conveyed and threaded onto the tightening wire 32 .
  • the tightening wire 32 has a certain axial length and is flexible, and the radial cross-sectional shape of the tightening wire 32 can be circular, oblate, rectangular, square or other shapes; similarly, the conveying member 53 also has a certain axis Lengthwise and flexible, the radial cross-sectional shape of the conveying member 53 can also be circular, oblate, rectangular, square or other shapes; limit.
  • the delivery device 50 also includes a delivery sheath 51, the anchoring device 10 is worn in the lumen of the delivery sheath 51, and the delivery sheath 51 is used to detachably connect the distal end of the anchoring device 10.
  • Anchoring assembly 34 is delivered to the annulus.
  • the distal part of the delivery sheath 51 is flexible, and the delivery sheath 51 is installed in the lumen of the second guiding sheath 72, and the distal end of the delivery sheath 51 can be driven by adjusting the bending angle of the distal end of the guiding device 70. bending.
  • an intervention channel from the outside of the patient's body to the heart is first established through the guide device 70, and then the delivery sheath 51 equipped with the anchor device 10 and the anchor assembly 34, together with The tightening wire 32 and the delivery member 53 are moved axially and distally in the lumen of the second guide sheath 72 of the guide device 70 until the delivery sheath 51 abuts against the valve annulus, and then passes through the anchoring device 10 drives the anchor assembly 34 within the delivery sheath 51 to anchor into the annulus.
  • a plurality of anchor assemblies 34 are respectively anchored into different positions along the circumference of the valve annulus through the same steps described above (as shown in FIG.
  • the spacing between the plurality of anchor assemblies 34 is adjusted by tightening the tightening wire 32 , so that the plurality of anchoring components 34 are relatively gathered (as shown in FIG. 3 ), thereby driving the annulus to shrink, and achieving the purpose of shrinking the annulus.
  • the anchor assembly 34 includes an anchor 340 for anchoring into the valve annulus and a threading structure disposed on the anchor 340 .
  • the anchor 340 is installed in the distal lumen of the delivery sheath 51 .
  • the distal end of the tightening wire 32 is connected to the threading structure of the first anchoring assembly 34 for anchoring into the annulus, and the proximal end of the tightening wire 32 slides through the threading of other anchoring assemblies 34 for anchoring into the annulus. structure.
  • the tightening wire 32 is connected to the anchor member 340 through a threading structure, so that multiple anchoring components 34 anchored into the valve annulus are connected in series, and the tightening of the tightening wire 32 can reduce the gap between the multiple anchoring components 34. The distance between them can realize shrinkage ring.
  • the hardness of the tightening wire 32 is greater than or equal to the hardness of the delivery member 53 , preferably greater than the hardness of the delivery member 53 . In this way, the hardness of the tightening wire 32 is relatively high and difficult to break. After the implant 30 is implanted in the valve annulus, the tightening wire 32 can stably connect multiple anchoring components 34 in series to avoid shrinkage due to the long-term action of the valve leaflet movement. The tight thread 32 breaks.
  • both the tightening wire 32 and the delivery member 53 can be made of biocompatible metal materials or polymer materials, especially the tightening wire 32, and the metal materials include but are not limited to the At least one of tungsten, nickel-titanium, tantalum, gold and their alloys, and the polymer material includes but not limited to at least one of polyethylene, polyamide, polypropylene, polyurethane and ultra-high molecular weight polyethylene.
  • the tightening wire 32 is preferably made of a metal material with good biocompatibility
  • the delivery member 53 is made of a biocompatible polymer material.
  • the metal material used for the tightening wire 32 has the ability to develop, during the implantation of all the anchor components 34, the state and position of the tightening wire 32 can be seen through the developing device, which is beneficial to reduce the occurrence of wire winding during the operation risk and increase the success rate of surgery.
  • the distal end of the delivery member 53 is connected to the proximal end of the tightening wire 32 , and the proximal end of the delivery member 53 extends outside the body of the patient.
  • the conveying member 53 and the tightening wire 32 are connected end-to-end, so as to avoid the tightening wire 32 and the conveying member 53 being side by side in the radial direction as far as possible, so as to reduce the tension between the tightening wire 32 and the conveying member 53 in the second guiding sheath 72 or The space occupied by the delivery sheath 51.
  • the conveying member 53 and the tightening wire 32 may not be connected end-to-end, which is not limited.
  • the proximal end of the tightening wire 32 forms a first loop 321, and the delivery member 53 is folded in half after passing through the first loop 321 so that the distal end of the delivery member 53 and the tightening Proximal U-shaped connection of wire 32.
  • the conveying member 53 can be an elongated wire including two head ends, and the conveying member 53 can be in a double-wire structure after U-shaped connection with the tightening wire 32 .
  • the delivery member 53 can be directly moved from the first The loop 321 is withdrawn so that the conveying element 53 is separated from the tightening wire 32 and withdrawn from the patient's body without cutting the conveying element 53.
  • the conveying element 53 can be cut outside the body so that the conveying element 53 has a non-closed double-wire structure, and then the conveying element 53 can be withdrawn.
  • the tightening wire 32 is a double-wire structure.
  • the tightening wire 32 can be an elongated wire including two head ends, one of the head ends of the tightening wire 32 passes through the threading structure of the first anchoring component 34 for anchoring into the valve annulus to form a U-shaped connection, tighten The two head ends of the wire 32 are fixed by the crimping tube 33, so that the tightening wire 32 is in a closed double-wire structure.
  • the tightening line 32 forms a first loop 321 at the proximal end and a second loop 322 at the distal end respectively on both sides of the pressure tube 33, and the distal end of the delivery member 53 and the first loop at the proximal end of the tightening line 32 321 forms a U-shaped connection, and the threading structure of the first anchoring component 34 forms a U-shaped connection with the second loop 321 at the distal end of the tightening wire 32 .
  • the tightening wire 32 is a single wire structure.
  • the tightening wire 32 can be an elongated wire including two head ends, one of the head ends of the tightening wire 32 passes through the threading structure of the first anchoring component 34 for anchoring into the annulus to form a U-shaped connection, and passes through
  • the pressure tube 33 is fixed so that the far end of the tightening line 32 forms a second loop 322, and the other head end of the tightening line 32 forms a first loop 321 at its proximal end and is fixed by another pressure tube 33.
  • the first loop The ring 321 is used to form a U-shaped connection with the distal end of the delivery member 53
  • the second ring 322 is used to form a U-shaped connection with the threading ring 347 of the first anchor assembly 34 . It can be understood that the risk of winding and crimping of the tightening wire 32 and the anchoring component 34 of the single-wire structure is reduced, and the operation is safer.
  • the pressure tube 33 can be replaced by other fixing parts such as a chuck.
  • the two head ends of the tightening wire 32 can also be bonded or knotted to form the first loop 321 and the second loop 322 , which is not limited thereto.
  • the tightening wire 32 can be made of a single wire or braided with multiple wires, preferably braided with a multi-wire, so that the tightening wire 32 is not easy to break.
  • a flexible tube 37 is sheathed between the proximal end and the distal end of the tightening wire 32 .
  • the flexible tube 37 may be but not limited to a PET heat-shrinkable tube, and the tightening wire 32 may be a double-wire structure or a single-wire structure. It can be understood that by sheathing the flexible tube 37 between the two ends of the tightening wire 32, the risk of wire winding and crimping between the tightening wire 32 and the anchoring assembly 34 can also be reduced, making the operation safer.
  • the tightening wire 32 is a metal wire bundle tube with better flexibility, and the metal wire bundle tube is braided by multiple strands of metal wire, and the metal wire can be but not limited to nickel-titanium wire, Tungsten wire etc.
  • the wire bundle tube is connected with the threading structure of the first anchoring assembly 34 for anchoring into the annulus when weaving, so that the far end of the wire bundle tube is formed with a second loop 322, and the proximal end of the wire bundle tube A first loop 321 is formed by bending and fixed with a pressure tube 33 .
  • the wire bundle tube as the tightening wire 32 , only one crimping tube 33 can form a single-wire structure with the first loop 321 and the second loop 322 , reducing the number of crimping tubes 33 .
  • the proximal end of the wire bundle tube may also be braided to form the first loop 321 .
  • the part between the proximal end and the distal end of the wire bundle tube can also be sheathed with a flexible tube 37, thereby further reducing the risk of winding and crimping the tightening wire 32 and the anchoring assembly 34, making the operation safer.
  • the crimping tube 33 on the tightening wire 32 cannot pass through the threading structure of the anchor assembly 34 .
  • the crimping tube 33 can be made of, but not limited to, stainless steel.
  • the crimping tube 33 is squeezed by crimping pliers to fix one end of the tightening wire 32 .
  • the compression tube 33 is entirely covered by a film, so as to reduce the risk of heart tissue such as valve annulus being damaged by the compression tube 33 .
  • proximal end of the tightening wire 32 and the distal end of the delivery member 53 may be detachably connected by, but not limited to, threaded connection, snap-fit connection and the like.
  • the proximal end of the tightening wire 32 is provided with a first threaded part
  • the distal end of the delivery member 53 is provided with a second threaded part
  • the first threaded part is threadedly connected with the second threaded part, so that the delivery
  • the distal end of the member 53 is detachably connected to the proximal end of the tightening wire 32 .
  • the conveying member 53 is a polymer wire with good flexibility
  • the second threaded part can be locked and rotated by a tool, so that the second threaded part is disconnected from the first threaded part, and then the conveying member 53 Separate from tightening line 32.
  • the conveying member 53 is a metal wire with a certain strength
  • the conveying member 53 can be rotated directly to disconnect the second threaded part from the first threaded part, and then separate the conveying member 53 and the tightening wire 32 .
  • the proximal end of the tightening wire 32 is provided with a slot
  • the far end of the delivery member 53 is provided with a buckle adapted to the slot, and the buckle is engaged with the slot so that the delivery member 53
  • the distal end is detachably connected to the proximal end of the tightening wire 32 . It can be understood that pulling the delivery member 53 toward the proximal end to disengage the buckle from the slot can separate the delivery member 53 from the tightening wire 32 .
  • the delivery device 50 further includes a lead wire 55 connected to the proximal end of the delivery member 53 , and the proximal end of the lead wire 55 has a tapered head.
  • the conveying element 53 has a double-wire structure
  • the lead wire 55 is fixedly connected to the proximal end of the conveying element 53 , so that the conveying element 53 has a closed double-wire structure.
  • one of the head ends of the delivery member 53 is folded in half after passing through the first loop 321 at the proximal end of the tightening wire 32, and then the two head ends of the delivery member 53 are inserted into the lead wire member 55 at the proximal end for extrusion. fixed.
  • the proximal end of the delivery member 53 is connected to the lead member 55 with a tapered head end, so that the delivery member 53 can easily pass through the threading structure of the anchor assembly 34 .
  • the lead member 55 can be made of biocompatible metal material or polymer material.
  • the anchoring member 340 includes an anchoring portion 341 and an anchoring seat 343 fixedly connected to the proximal end of the anchoring portion 341 .
  • the threading structure of the anchor component 34 includes a connecting piece 345 and a threading ring 347 .
  • the connecting piece 345 is movably sleeved on the anchor seat 343
  • the threading ring 347 is movably connected to the connecting piece 345
  • the tightening wire 32 is connected to the threading ring 347 to be connected to the anchoring assembly 34 .
  • the anchor seat 343 is used for detachable connection with the distal end of the anchoring device 10, and the anchor portion 341 is used for anchoring into the annulus so that the anchoring assembly 34 is implanted on the annulus.
  • the anchoring portion 341 is a helical anchor with a tip, which is easy to be anchored into the valve annulus, and the anchoring component 34 is not easy to fall off after being implanted.
  • the anchoring portion 341 may also have another suitable configuration that enables the anchoring portion 341 to engage with and be substantially fixed to the tissue, such as but not limited to barbs, hooks, tines, and the like. And in order to facilitate transportation, at least part of the barbs and hooks are made of materials with shape memory function.
  • the connecting piece 345 can be movably sleeved on the proximal end of the anchoring portion 341, and the anchoring portion 341 is designed as a helical anchor or a limiting member is designed on the anchoring portion 341 so that the connecting piece 345 does not disengage from the anchoring portion 341.
  • the threading structure of the anchor assembly 34 may also only include a threading ring 347 sleeved on the anchor member 340 , preferably, the threading ring 347 can be movably sleeved on the anchor seat 343 .
  • the threading structure can also be a threading hole opened on the anchor member 340 , preferably, the threading hole can be provided on the anchor seat 343 .
  • the anchor base 343 includes a supporting portion 3433 , and the connecting member 345 is movably sleeved on the supporting portion 3433 .
  • the anchor seat 343 also includes a first supporting body 3432 and a second supporting body 3434 respectively connected to the proximal end and the distal end of the supporting part 3433, the first supporting body 3432 and the The outer diameters of the second supporting body 3434 are equal and larger than the outer diameter of the supporting portion 3433 .
  • the first supporting body 3432 , the supporting portion 3433 and the second supporting body 3434 are roughly in the shape of an “I” shape, forming a connecting groove 3435 surrounding the supporting portion 3433 . As shown in FIGS. 9 and 10 , when the connecting piece 345 is sheathed on the support portion 3433 , the connecting piece 345 is at least partially received in the connecting groove 3435 .
  • the anchor seat 343 also includes a first connecting portion 3431 disposed at the proximal end of the first support body 3432 and an insertion portion 3437 disposed at the distal end of the second support body 3434 .
  • the first connecting portion 3431 is used for detachable connection with the distal end of the anchoring device 10 .
  • the insertion part 3437 is used for connecting the proximal end of the anchoring part 341 .
  • the insertion portion 3437 is provided with an insertion hole extending in the axial direction of the anchor member 340, and the proximal end of the anchor portion 341 is inserted into the insertion hole and fixed by welding or gluing (see FIG. 9 and Figure 10).
  • the anchoring portion 341 can be fixedly connected to the insertion portion 3437 directly by welding or the like, and the insertion portion 3437 does not need to have an insertion hole.
  • the anchoring part 341 can also be fixedly connected to the distal end of the second support body 3434 directly by means of welding or the like, so that the insertion part 3437 does not need to be provided.
  • the connecting member 345 defines an assembly hole 3452 and a connection hole 3454 .
  • the anchor base 343 is fitted in the assembly hole 3452 , specifically, the connector 345 is movably sleeved on the support portion 3433 of the anchor base 343 through the assembly hole 3452 .
  • the connecting hole 3454 is used for movably connecting the threading ring 347 .
  • the support portion 3433 of the anchor base 343 is inserted into the assembly hole 3452 of the connector 345 , so that the connector 345 is sleeved on the support portion 3433 .
  • the threading ring 347 passes through the connecting hole 3454 of the connecting piece 345 , so as to be fastened with the connecting piece 345 , so as to realize the flexible connection between the threading ring 347 and the connecting piece 345 .
  • the connecting member 345 can be a connecting ring, and the connecting ring is directly buckled with the threading ring 347 .
  • the diameter of the assembly hole 3452 is larger than the diameter of the support part 3433 and smaller than the maximum outer diameter of the anchor seat 343 (that is, the outer diameter of the first support body 3432 and the second support body 3434), so that the connecting piece 345 can move It is sheathed on the support portion 3433 of the anchor base 343 and will not fall off from the anchor base 343 .
  • the connecting piece 345 can rotate 360 degrees around the central axis Z of the anchoring piece 340 (see FIG. 9 ), that is, the connecting piece 345 has a rotational degree of freedom to rotate around the central axis Z of the anchoring piece 340 .
  • the axial width p of the connecting groove 3435 may be greater than the axial thickness q of the fitting portion 3451 (see FIG. 12 ), preferably 2-3 times the axial thickness q of the fitting portion 3451, so that the connection The piece 345 can move along the axial direction of the anchor piece 340 , that is, the connection piece 345 also has a degree of freedom of translation along the central axis Z of the anchor piece 340 (see FIG. 9 ).
  • the connecting member 345 has two degrees of freedom, including a rotational degree of freedom to rotate about the central axis Z of the anchoring member 340 , and a translational degree of freedom to move along the central axis Z of the anchoring member 340 .
  • the connecting member 345 may have one degree of freedom, that is, a degree of freedom of rotation around the central axis Z of the anchoring member 340 .
  • the threading ring 347 has two degrees of freedom, including a rotational degree of freedom (rotatable 360 degrees) around its own central axis X and a rotational freedom around the anchor 340.
  • the degree of freedom of rotation of the threading ring 347 around the radial axis Y can reach 90 degrees (90 degrees to the left and 90 degrees to the right).
  • the threading ring 347 can be a circular ring or an elliptical ring, and the shape of its axial section can also be circular or elliptical.
  • the assembly hole 3452 and the connection hole 3454 of the connecting piece 345 can be round holes or oval holes.
  • the threading ring 347 is a circular ring, and its axial cross-sectional shape is also circular; the fitting hole 3452 and the connecting hole 3454 of the connecting piece 345 are both circular holes.
  • the connecting member 345 has a rotational degree of freedom to rotate around the central axis Z of the anchoring member 340 and a translational degree of freedom to move along the central axis Z of the anchoring member 340
  • the threading ring 347 has a The rotational degree of freedom of the rotation of its own central axis X and the rotational degree of freedom of the left and right deflection around the radial axis Y.
  • the connecting member 345 can rotate around the central axis Z of the anchoring member 340, the threading ring 347 fastened to the connecting member 345 can tighten the thread 32 Under the action of tension during tightening, move to the state after tightening with the tightening wire 32, the threading direction of the threading ring 347 can be along the circumferential direction of the annulus, so that the resistance of the tightening wire 32 during the contraction process is greatly reduced, There is no bending of the tightening wire 32 and the contraction is stable and smooth. Furthermore, the connecting piece 345 can move along the axial direction of the anchoring piece 340.
  • the tightening wire 32 can pull the connecting piece 345 to move along the axial direction. Moving up and down further reduces the bending of the tightening wire 32, and the tightening wire 32 is distributed on the same plane as far as possible and shrinks stably and smoothly.
  • the threading ring 347 itself is movable, and the effect of adjusting the direction with the connecting piece 345 to reduce the contraction resistance of the tightening line 32 is better.
  • the tightening force is reduced and the force of the tightening force distributed on each anchor component 34 is more uniform, and the corresponding single anchor component 34
  • the acting force is also greatly reduced, which reduces the force of the anchoring component 34 on the valve, reduces the risk of valve damage, and avoids the situation that the tightening force of a single anchoring component 34 accounts for a large proportion, reducing the The risk of the anchor component 34 falling off, the implantation is safer.
  • the anchoring component 34 is made of materials with good biocompatibility as a whole, including but not limited to metal materials (such as stainless steel) or polymer materials (such as PEEK, PET ).
  • the anchor seat 343 and the anchor portion 341 are preferably made of stainless steel with high hardness.
  • Both the connecting piece 345 and the threading ring 347 can be made of stainless steel or polymer materials (such as PEEK, PET), preferably made of flexible polymer materials, which can be twisted and deformed to facilitate their rotation.
  • the anchoring component 34 is detachably connected to the distal end of the anchoring device 10 .
  • the anchoring device 10 includes a driving tube 12 and a connecting rod 14 mounted in the driving tube 12.
  • the second connecting part 122, the connecting rod 14 axially passes through the mating first connecting part 3431 and the second connecting part 122 so that the anchor assembly 34 is kept connected with the anchoring device 10, and the driving tube 12 is used to drive the anchor Anchoring assembly 34 (ie, anchor 340) is anchored into the annulus.
  • first connecting part 3431 and the second connecting part 122 are S-shaped buckles respectively arranged on the proximal end of the anchor seat 343 and the distal end of the driving tube 12, and both the first connecting part 3431 and the second connecting part 122 have an inner cavity. As shown in FIG.
  • the anchoring device 10 can be made of metal material or polymer material, preferably made of metal material with high hardness such as stainless steel.
  • first connecting portion 3431 and the second connecting portion 122 may be a matching structure of a locking block and a locking slot.
  • the anchoring device 10 can also be composed of a driving tube 12 and a connecting tube sheathed outside the driving tube 12, the distal end of the connecting tube is sheathed outside the first connecting part 3431 and the second connecting part 122 that are mated and connected, It can also play a role of restricting the separation of the first connection part 3431 and the second connection part 122 .
  • the wall of the delivery sheath 51 is provided with a channel 512 extending proximally from the distal end, and the channel 512 communicates with the lumen of the delivery sheath 51 , and The distal end of the channel 512 has an opening.
  • the transcatheter shrinking ring system also includes a stopper 59, which is arranged at the distal end of the delivery sheath 51, and the stopper 59 is used to close the distal opening of the channel 512 so as to connect the distal end of the anchor 340 to the distal end of the delivery sheath 51.
  • the cinch lines are spaced apart.
  • the anchor 340 is located in the delivery sheath.
  • the portion of the tightening wire 32 extending distally from its connection with the threading structure of the anchor assembly 34 is located outside the delivery sheath 51, thereby connecting the distal end of the anchor 340 to the tightening wire.
  • 32 can prevent the tightening wire 32 from winding around the anchor member 340, avoiding the problem of wire winding, and is conducive to the smooth implantation of the anchoring component 34.
  • the channel 512 extends to the distal end of the delivery sheath 51 in a "one" shape, so that the distal end of the channel 512 has an opening, and the proximal end of the channel 512 is closed.
  • the channel 512 may also extend to the proximal end of the delivery sheath 51 .
  • the side of the connecting piece 345 away from the anchor seat 343 is protruded with a clamping end 3455, and the radial width of the clamping end 3455 is the same as the through groove of the delivery sheath 51.
  • the radial width of 512 is adapted, and when the anchor assembly 34 is worn on the distal end of the delivery sheath 51 , the holding end 3455 is held in the through groove 512 . In this way, it can prevent the connecting member 345 from rotating to drive the threading ring 347 to rotate during the process of delivering the anchor assembly 34 , thereby ensuring stable and smooth delivery of the anchor assembly 34 .
  • the clamping end 3455 moves in the channel 512 along with the overall movement of the anchor assembly 34 .
  • the threading structure of the anchoring assembly 34 is at least partially exposed from the through groove 512 and is located outside the delivery sheath 51 , and the tightening wire 32 is connected to the part of the threading structure of the anchoring assembly 34 located outside the delivery sheath 51 .
  • the tightening wire 32 and the delivery member 53 connected to its proximal end are located outside the delivery sheath 51 as a whole, and the proximal end of the delivery member 51 extends out of the patient's body through the lumen of the second guide sheath 72 .
  • the threading ring 347 is at least partly exposed from the through groove 512 and is located outside the delivery sheath 51 , and the tightening wire 32 is connected to the part of the threading ring 347 located outside the delivery sheath 51 . In this way, the radial dimension of the delivery sheath 51 can be reduced.
  • the radial width of the through groove 512 is greater than the axial thickness of the threading ring 347 (that is, the thickness of the threading ring 347 in the axial direction), so that the threading ring 347 can be at least partially exposed from the through groove 512, and the tightening wire 32 is connected to the The threaded loop 347 can be entirely located outside the delivery sheath 51 . Further, the radial width of the through groove 512 is smaller than the maximum outer diameter of the threading ring 347 to prevent the through groove 512 from being too wide, and the threading ring 347 is likely to fall into the lumen of the delivery sheath 51 during the delivery of the anchor assembly 34 .
  • the axial length of the through groove 512 is greater than the maximum outer diameter of the threading ring 347, so that the entire threading ring 347 can be exposed from the through groove 512.
  • the threading ring 347 is located outside the delivery sheath 51 as a whole, and the threading space is larger, which is conducive to tightening
  • the wire 32 passes through the threading ring 347, and the connection operation is simple and convenient.
  • the axial length of the channel 512 is greater than the axial distance H between the proximal end of the support portion 3433 and the distal end of the anchor portion 341 (see FIG.
  • the anchoring member 340 and the tightening wire 32 are completely isolated from the inner and outer sides of the delivery sheath 51, which is more conducive to avoiding the problem of winding of the anchoring component 34 during delivery and implantation.
  • the threading structure of the anchoring assembly 34 can also be entirely located in the lumen of the delivery sheath 51, and the tightening wire 32 passes through the channel 512 to enter the inner lumen of the delivery sheath 51 and the threading of the anchoring assembly 34. Ring 347 connects.
  • the part of the tightening wire 32 that extends distally from its connection with the threading structure of the anchor assembly 34 is located outside the delivery sheath 51, and the tightening wire 32 is connected with the threading structure of the anchor assembly 34 from there.
  • the proximally extending part and the delivery member 53 connected to the proximal end of the tightening wire 32 are located in the lumen of the delivery sheath 51 , and the proximal end of the delivery member 53 extends out of the patient's body through the inner lumen of the delivery sheath 51 .
  • the stopper 59 is movably arranged on the distal end of the delivery sheath 51, the proximal end of the stopper 59 extends along the axial direction of the delivery sheath 51, and the distal end of the stopper 59 fits The circumferential direction of the delivery sheath 51 and the distal opening of the channel 512 are closed when no external force is applied.
  • the stopper portion 59 can be a retaining wire, at least the distal end of the retaining wire has a shape memory function, and the distal end of the retaining wire is shaped as an arc extending along the circumferential direction of the delivery sheath 51 , preferably a circular arc.
  • the distal end of the blocking wire closes the distal opening of the through groove 512 .
  • the distal opening of the through groove 512 is opened by pulling the retaining wire to the proximal end so that the anchor assembly 34 is worn on the delivery sheath tube 51, so that the threading of the anchor assembly 34 Ring 347 enters through groove 512 .
  • the anchor assembly 34 is delivered, the pulling force on the retaining wire is released, and the distal end of the retaining wire returns to its original position due to its own memory function to close the distal opening of the through groove 512 again.
  • the threading ring 347 of the anchor assembly 34 cannot slide out from the distal opening of the through groove 512, thereby preventing the anchor assembly 34 from breaking away from the delivery sheath 51 during delivery, ensuring that the anchor assembly
  • the anchor 340 is always in the delivery sheath 51 during delivery, so as to prevent the tightening wire 32 from being entangled with the anchor 340 .
  • the implant 30 further includes at least one spacer 36, the spacer 36 is transported along the delivery member 53 and put on the tightening wire 32, and the spacer 36 is located on both sides. Between anchor components 34. It can be understood that, setting the spacer 36 between the two anchoring assemblies 34 can prevent the excessive tightening of the tightening wire 32 from causing the distance between two adjacent anchoring assemblies 34 to be too short and damage the annulus.
  • the spacer 36 can play a buffering role, disperse the tightening force on the anchoring component 34, and ensure the stable implantation of the anchoring component 34.
  • the spacer 36 is a cylindrical member with a certain length, preferably made of a biocompatible material.
  • the spacer 36 may be wrapped with a membrane to reduce the risk of cardiac tissue such as valve annulus being damaged by the spacer 36 .
  • a spacer 36 (as shown in FIGS. A spacer 36 is provided between two or more anchor components 34 , which is not limited thereto.
  • the transcatheter ring shrinkage system 1 further includes a pusher 90 for pushing the spacer 36 .
  • the distal end of the pushing member 90 is provided with a guiding hole 92 for the proximal end of the conveying member 53 to move through.
  • the delivery member 53 passes through the guide hole 92 of the pusher 90, and the pusher 90 pushes the spacer 36 along the delivery member 53 into the second guide sheath 72 of the guide device 70 , the delivery sheath 51 is threaded into the second guiding sheath 72 to push the spacer 36 in the second guiding sheath 72 , so that the spacer 36 is threaded on the tightening wire 32 along the delivery piece 53 .
  • the delivery sheath 51 and the anchoring device 10 are withdrawn, and the spacer 36 is inserted at the proximal end of the delivery member 53 and the delivery member 53 is threaded along the line.
  • the pusher 90 pushes the spacer 36 into the second guide sheath 72 of the guide device 70 along the delivery member 53 along the push direction b.
  • the pusher 90 is taken out, and the second anchor assembly 34 worn on the delivery sheath 51 is passed on the delivery member 53 through the threading ring 347 exposed outside the delivery sheath 51, and the delivery sheath 51 is further threaded.
  • the spacer 36 is located on the distal side of the delivery sheath 51 .
  • the delivery sheath 51 moves axially to the distal end in the second guide sheath 72, and can be delivered along the delivery member 53 to wear the spacer 36 and the anchor assembly 34 on the tightening wire 32, And push the spacer 36 to the annulus, then the anchoring device 10 pushes the second anchor assembly 34 out of the delivery sheath 51 and anchors the second anchor assembly 34 into the annulus, so that the spacer 36 is located between the two Between the anchor components 34.
  • the same steps are repeated, and multiple anchor assemblies 34 are sequentially implanted into the annulus, and at the same time, the spacer 36 is inserted between every two or more anchor assemblies 34 in sequence. Wherein, the distance between two adjacent anchor assemblies 34 needs to be greater than the axial length of the spacer 36 .
  • the transcatheter ring shrinkage system 1 further includes an adjustment device 80
  • the implant 30 further includes a wire retractor 38 .
  • the adjusting device 80 is used for conveying and controlling the wire take-up 38 .
  • the wire take-up 38 is used for adjusting the tightening wire 32 to adjust the distance between the multiple anchor components 34 , and to lock the tightening wire 32 after the distance between the multiple anchor components 34 is adjusted.
  • the wire take-up device 38 is threaded on the tightening wire 32 through the conveying member 53 and the tightening wire 32 can be released smoothly, without the need to implant the wire retractor 38 into the patient's body in advance, which simplifies the operation process and reduces the risk of surgery. Difficulty, shorten operation time.
  • the distal end of the delivery member 53 is connected to the proximal end of the tightening wire 32, and the proximal end of the delivery member 53 extends outside the body of the patient, and the anchor assembly 34, the spacer 36 and the wire retractor 38 can be extended to the outside of the body by
  • the conveying part 53 is transported to wear on the tightening wire 32, so that the tightening wire 32 can choose a suitable implant length, and the length of the tightening wire 32 on the valve annulus is adjusted and locked by the wire retractor 38, without the need for Tighten the thread 32 for cutting.
  • the wire take-up 38 includes a housing 381 and a winding shaft 383 rotatably disposed in the housing 381 .
  • the wire take-up 38 moves toward the distal end of the delivery member 53 so that the proximal end of the tightening wire 32 can move through the housing 381 and the winding shaft 383 .
  • the winding shaft 383 rotates relative to the casing 381 to wind the tightening wire 32 , and when the winding shaft 383 stops rotating, the tightening wire 32 is locked in the radial space between the winding shaft 383 and the casing 381 .
  • the tightening wire 32 can be wound by controlling the rotation of the winding shaft 383 relative to the housing 381, so that the tightening wire 32 is continuously tightened to shrink the annulus until the blood regurgitation weakens or disappears and then stops the rotation. Winding the bobbin 383, the tightening wire 32 is locked in the radial space between the bobbin 383 and the casing 381 at this time, and the tightening wire 32 maintains a certain length on the annulus. The tightening wire 32 is wound and locked by the wire take-up device 38, and the locking effect of the tightening wire 32 is good.
  • the wire take-up device 38 can be directly controlled to further wind the tightening wire 32 to reduce the annulus so that the regurgitation weakens or disappears, avoiding secondary surgery. patients inflict great harm.
  • the wire take-up 38 can be made of biocompatible materials, such as stainless steel, which is not limited.
  • the tightening wire 32 is wound at least three times on the winding shaft 38, and the friction force between the tightening wires 32 in each circle can offset the pulling force generated by the movement of the valve leaflets, so as to ensure that the tightening wire 32 is not pulled, and the tightening wire 32 is not pulled. Tight wire 32 maintains a certain length on the annulus.
  • the casing 381 includes a bottom case 3812 and a casing 3814 . Both the proximal end and the distal end of the shell 3814 have openings, and the bottom shell 3812 is fixedly connected to the distal end of the shell 3814 to form an installation space 3816 .
  • the wire take-up 38 also includes a limiting column 385 , a rotation stop wheel 387 and an elastic member 389 .
  • the limiting column 385 , the elastic member 389 , the anti-rotation wheel 387 and the winding shaft 383 are arranged in the installation space 3816 of the casing 381 .
  • the winding shaft 383 is provided with a through hole 3832 along its radial direction
  • the shell 3814 is provided with two wire holes 3818 on both sides of the winding shaft 383, and the two wire holes 3818 are connected to the winding shaft 383.
  • the central axes of the two thread holes 3818 and the central axes of the through holes 3832 are in the same plane, and the rotatable winding shaft 383 makes the central axes of the through holes 3832 and the central axes of the two thread holes 3818 collinear, which is conducive to conveying
  • the member 53 smoothly passes through the two wire holes 3818 and the through hole 3832, so that the wire take-up device 38 can be delivered to the tightening wire 32.
  • the distal end of the limiting post 385 is fixedly connected to the bottom case 3812 .
  • the anti-rotation wheel 387 is sleeved on the limiting post 387 and can move axially along the limiting post 385 .
  • the near-end surface of the anti-rotation wheel 387 is provided with some first helical teeth 3871 along the circumference, and the far-end surface of the winding shaft 383 is provided with some second helical teeth 3831 along the circumference.
  • the helical tooth 3831 can cooperate with the first helical tooth 3871 to rotate in one direction.
  • the elastic member 389 is located between the anti-rotation wheel 387 and the bottom shell 3812, one end of which is against the bottom case 3812, and the other end is against the anti-rotation wheel 387, and the elastic part 389 is used to provide elastic force to the anti-rotation wheel 387, so that the anti-rotation wheel
  • the first helical tooth 3871 of 387 engages the second helical tooth 3831 of the winding shaft 383 .
  • the anti-rotation wheel 387 After passing through the angle of one helical tooth, the anti-rotation wheel 387 will move to the proximal end after receiving the elastic force given by the elastic member 389, so that the first helical tooth 3831 and the second helical tooth 3871 fit together again, and the bobbin 383 can continue to move relative to the shell. Body 381 and anti-rotation wheel 387 rotate.
  • the second helical tooth 3871 cannot move the anti-rotation wheel 387 to the distal end, and the second helical tooth 3871 cannot pass over any first helical tooth 3831 so that the winding shaft 383 cannot reverse.
  • the elastic member 389 may be, but not limited to, a spring, a tubular shrapnel, an elastic bellows, and the like.
  • the distal surface of the bobbin 383 is also provided with a groove (not shown in the figure) that matches the proximal end of the limit post 385 , and the proximal end of the stop post 385 is accommodated in the bobbin 383 In the groove at the far end, and the proximal end surface of the limit post 385 is in contact with the distal end surface of the bobbin 383, so as to limit the axial displacement of the bobbin 383 in the installation space 3816 together with the proximal end of the housing 3814, so that the The spool 383 can only rotate.
  • the proximal end of the anti-rotation wheel 387 is also provided with a limit boss 3873, and the far end of the housing 3814 is correspondingly provided with a limit groove 3813, and the limit boss 3873 is stuck in the corresponding limit groove 3813, which can limit the anti-rotation wheel 387 from occurring. Rotate so that the anti-rotation wheel 387 can only move along the axial direction of the limit post 385 .
  • the tightening wire 32 is pulled to shrink the ring so that the blood reflux is weakened or eliminated, and the locking nails can be delivered along the delivery member 53 By locking the tightened tightening wire 32 so that the tightened wire 32 maintains the tightened state, the conveying member 53 can be withdrawn.
  • the adjustment device 80 includes a threaded rod 82 , a rotating tube 84 and an outer sheath 86 arranged from inside to outside.
  • the outer sheath tube 86 is clamped with the housing 381 of the wire take-up device to limit the rotation of the housing 381;
  • the rotating tube 84 is used for clamping with the proximal end of the winding shaft 383;
  • the threaded rod 82 is used for threaded connection with the winding shaft 383 and Pressing against the rotating tube 84 keeps the rotating tube 84 connected to the bobbin 383 . Therefore, the winding shaft 383 can be driven to rotate by rotating the rotating tube 84 to wind the tightening wire 32 to tighten the tightening wire 32 .
  • the shell of the housing 381 is provided with a slot 3811, and the distal end of the outer sheath tube 86 is provided with a claw 862 corresponding to the slot 3811. Through the cooperation between the claw 862 and the slot 3811, the outer sheath tube 86 is connected with the housing 381.
  • the proximal end of the winding shaft 383 protrudes from the proximal opening of the shell 3814, and the proximal end of the winding shaft 383 is provided with a threaded hole along its axial direction.
  • a first boss 842 protrudes from the inner wall of the rotating tube 84
  • a second boss 822 protrudes from the outer wall of the threaded rod 82 .
  • the threaded rod 82 is screwed with the threaded hole, that is, the threaded rod 82 is screwed with the winding shaft 383, so that the first boss 842 is pressed against the gap between the winding shaft 383 and the second boss 822.
  • the rotating tube 84 remains connected to the winding shaft 383 .
  • the outer sheath tube 86 restricts the rotation of the casing 381, and the rotation of the rotating tube 84 can drive the threaded rod 82 and the bobbin 383 to rotate synchronously, so that the bobbin 383 rotates relative to the casing 381 to wind the take-up wire 32 and tighten it.
  • the thread 32 is tightened to realize the ring shrinkage.
  • the anchoring device 10, the delivery device 50, the guiding device 70, and the adjusting device 80 included in the transcatheter ring shrinkage system 1 also have corresponding control handles, and their structures are basically similar to those in the prior art. , which will not be described in detail.
  • transcatheter ring reduction system 1 The application process and work of the transcatheter ring reduction system 1 according to the embodiment of the present application will be described below by taking the application of the transcatheter ring reduction system 1 in mitral annuloplasty as an example in conjunction with Fig. principle.
  • the surgical route is: transfemoral vein - inferior vena cava - right atrium (RA) - atrial septum (AS) - left atrium (LA) - mitral valve (MV) annulus.
  • the first step is to puncture through the femoral vein, and establish the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral annulus through the guide wire (the guide wire and atrial septal puncture device are not shown in the figure). track.
  • the guiding device 70 is advanced along the guide wire until its distal end passes through the foramen ovale to the left atrium and near the annulus, and then the guide wire is withdrawn.
  • the threading ring 347 of the first anchoring assembly 34 is connected to the distal end of the tightening wire 32 , and the proximal end of the tightening wire 32 is detachably connected to the distal end of the delivery member 53 .
  • the first anchoring assembly 34 is assembled on the distal end of the delivery sheath 51 and detachably connected to the anchoring device 10, wherein the part of the threading ring 347 of the first anchoring assembly 34 is exposed from the through groove 512,
  • the tightening wire 32 and the delivery member 53 are located outside the delivery sheath 51; then, the delivery sheath 51 is moved axially and distally in the guide device 70 to a predetermined treatment site where its distal end abuts the annulus.
  • the fourth step pulls the retaining wire so that the retaining wire moves proximally to open the distal opening of the through groove 512, and then utilizes the anchoring device 10 worn in the inner cavity of the delivery sheath 51 to place the A first anchor assembly 34 is implanted in the annulus of the mitral valve.
  • the delivery sheath 51 is withdrawn proximally, so that the first anchoring assembly 34 is completely disengaged from the delivery sheath 51 , and the connection between the anchoring device 10 and the first anchoring assembly 34 is released.
  • the anchoring device 10 and the delivery sheath 51 are withdrawn, and the spacer 36 is introduced into the guide device 70 through the delivery member 53; then the third step and the second step are repeated.
  • Four steps pass the proximal end of the delivery member 53 through the threading ring 347 of the second anchor assembly 34 (the second anchor assembly 34 has been connected to the distal end of the anchoring device 10 and worn on the delivery sheath 51) and The delivery sheath 51 is advanced in the introducer 70, and the forward push of the delivery sheath 51 transports the first spacer 36 and the second anchor assembly 34 along the delivery member 53 to be threaded on the tightening wire 32 And delivered to the vicinity of the annulus, the spacer 36 is interposed between the first anchor component 34 and the second anchor component 34 .
  • DSA ultrasound and digital subtraction angiography
  • the sixth step repeat the fifth step, sequentially implant the anchoring component 34 and the spacer 36 from the anterior trigone of the mitral valve along the posterior annulus to the posterior trigone or reverse, so that the anchoring component 34 and the spacer The components 36 are evenly distributed on the valve annulus (as shown in FIG. 2 ). After a sufficient number of anchoring components 34 are implanted, the anchoring device 10 and the delivery sheath 51 are withdrawn.
  • the wire take-up 38 is connected to the far end of the adjusting device 80, and the proximal end of the conveying member 53 is passed through the wire take-up 38, and the wire take-up 38 is sent to the tightening wire 32 along the conveying member 53 Then, the rotating tube 84 of the adjusting device 80 is forwardly rotated, so that the winding shaft 383 of the wire take-up device 38 adjusts the length of the tightening wire 32 on the annulus to reduce the distance between multiple anchor assemblies 34, thereby driving the annulus shrink.
  • the rotating tube 84 stops rotating, the wire take-up device 38 locks and tightens the tightening wire 32, and then reverses the threaded rod 82, so that the wire take-up device 38 is separated from the adjusting device 80 so as to withdraw the adjusting device 80 , so that the implant 30 is left on the annulus (as shown in FIG. 3 ), and the ring shrinkage operation is completed.
  • the driving tube 12 of the anchoring device 10 can be reversely rotated in combination with DSA and ultrasonic equipment, and the anchor can be loosened. Fix the anchor assembly 34 so that the tightening wire 32 is disengaged, and then re-tighten the anchor assembly 34 to perform implantation.
  • transcatheter ring shrinkage system 1 provided in the present application can also be applied to the ring shrinkage of the tricuspid valve ring, which will not be repeated here.
  • the transcatheter ring retraction system 1 provided in the present application can also be used to implant a plurality of anchor assemblies 34 connected in series through tightening wires 32 in heart tissues such as left ventricle wall or right ventricle wall. Tighten the tightening wire 32 to reduce the distance between multiple anchor components 34, so as to reduce the volume of the ventricle by narrowing the ventricle to achieve the purpose of reducing the valve annulus, thereby achieving the treatment of mitral regurgitation or tricuspid regurgitation .
  • the implant 30 can also be implanted under the annulus, that is, the implant 30 can also be implanted in the left ventricle under the mitral valve annulus. wall or right ventricular wall below the tricuspid annulus.
  • implanting the implant 30 on the wall of the left ventricle is especially suitable for treating heart failure and functional mitral valve regurgitation caused by abnormal left ventricle function.
  • the guide device 70 can be punctured from the femoral artery, retrogradely enters the left ventricle through the aortic valve, and implants the implant 30 on the wall of the left ventricle through the delivery device 50 and the anchoring device 10.
  • the tightening wire 32 is tightened and directly restrains the The dilation of the left ventricle achieves the purpose of reducing the mitral valve annulus, and this subannulus can preserve the natural structure of the mitral valve. That is to say, the transcatheter ring shrinkage system 1 of the present application is not only used to shrink the valve ring during annuloplasty, but also can be used to reduce the volume of the ventricle during ventricular volume reduction. The use process of valve annuloplasty is basically similar and will not be repeated here.
  • the transcatheter ring retraction system 1 of the present application can be used to anchor multiple rings connected in series through the tightening wire 32 on cardiac tissues such as the mitral valve ring, tricuspid valve ring, left ventricle wall, and right ventricle wall.
  • the anchor component 34 narrows the distance between multiple anchor components 34 by tightening the wire 32, so as to realize the treatment of heart failure caused by mitral valve regurgitation, tricuspid valve regurgitation or left ventricular dysfunction.

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Abstract

一种经导管缩环系统及其应用。该经导管缩环系统包括多个锚定组件(34)、相互连接的收紧线(32)及输送件(53)。输送件(53)具有柔性且延伸至体外，锚定组件(34)沿输送件(53)输送并穿装至收紧线(32)上，在多个锚定组件(34)锚入心脏组织后，收紧线(32)调整多个锚定组件(34)的间距并与输送件(53)分离。通过设置与收紧线(32)可分离连接的输送件(53)，并通过输送件(53)将多个锚定组件(34)依次穿装至收紧线(32)上，使得收紧线(32)可选择合适的植入长度，从而不需要在体内对收紧线(32)进行裁剪，避免了产生线材上颗粒的脱落，手术更安全。

Description

经导管缩环系统及其应用
本申请要求于2021年9月3日提交至中国专利局、申请号为202111032580.9、申请名称为“防绕线的输送装置及经导管缩环系统”的中国专利申请的优先权，同时要求于2021年9月3日提交至中国专利局、申请号为202111031389.2、申请名称为“具有穿线环的锚定组件、植入物及经导管缩环系统”的中国专利申请的优先权，此外还要求于2021年12月31日提交至中国专利局、申请号为202111677720.8、申请名称为“经导管缩环系统及其应用”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，尤其涉及一种经导管缩环系统及其应用。
 背景技术
二尖瓣反流(简称：MR)是一种常见的心脏瓣膜疾病，包括原发性二尖瓣反流和继发性二尖瓣反流。原发性二尖瓣反流是由于二尖瓣瓣叶异常、腱索断裂或乳头肌功能不全导致二尖瓣前后叶吻合不良，继发性二尖瓣反流是由于瓣环扩张、左房及左室扩大导致二尖瓣前后叶吻合不良。近年来二尖瓣介入治疗发展迅速，主要包括瓣膜修复术或瓣膜置换术。其中，二尖瓣瓣环成形术是一种常见的修复术式，通过缩小患者瓣环尺寸以减轻二尖瓣反流。
现有技术中，通过经导管路径，依次在二尖瓣的瓣环植入多个可滑动连接在一根绳索上的锚定组件，然后拉紧绳索达到缩小瓣环的目的，从而改善二尖瓣反流。由于锚定组件需从体外穿装在绳索上，绳索自二尖瓣瓣环处延伸至体外，在多个锚定组件植入瓣环后，牵拉绳索达到改善二尖瓣反流的效果后，需对绳索进行锁结使收紧后的绳索锁紧在瓣环上保持一定长度，然后裁剪多余的绳索。然而，在体内裁剪绳索时会产生绳索材料颗粒的脱落，容易造成栓塞。
 技术问题
本申请旨在提供一种经导管缩环系统及其应用，以解决在体内对收紧线进行裁剪产生线材上颗粒的脱落，容易造成栓塞的问题。
 技术解决方案
一方面，本申请提供一种经导管缩环系统，包括多个锚定组件、相互连接的收紧线及输送件。输送件具有柔性且延伸至体外，锚定组件沿输送件输送并穿装至收紧线上，在多个锚定组件锚入心脏组织后，收紧线调整多个锚定组件的间距并与输送件分离。
另一方面，本申请还提供一种如上所述经导管缩环系统的应用，所述经导管缩环系统用于在瓣环成形术中收缩瓣环，或者心室减容术中减小心室容积。
 有益效果
本申请提供的经导管缩环系统及其应用中，通过设置与收紧线可分离连接的输送件，并通过输送件将多个锚定组件依次穿装至收紧线上，使得收紧线可选择合适的植入长度，从而不需要在体内对收紧线进行裁剪，避免了产生线材上颗粒的脱落，手术更安全。
 附图说明
为了更清楚地说明本申请实施方式的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本申请一实施方式提供的经导管缩环系统的结构示意图。
图2是本申请一实施方式提供的植入物植入瓣环且收紧线未收紧的示意图。
图3是图2中的收紧线收紧后的示意图。
图4是本申请一实施方式提供的输送件、收紧线与第一个锚定组件的连接示意图。
图5是本申请另一实施方式提供的输送件、收紧线与第一个锚定组件的连接示意图。
图6是本申请又一实施方式提供的输送件、收紧线与第一个锚定组件的连接示意图。
图7是本申请再一实施方式提供的收紧线与第一个锚定组件的穿线结构的连接示意图。
图8是图4中输送件与引线件的结构示意图。
图9是本申请一实施方式提供的锚定组件的立体结构示意图。
图10是图9中的锚定组件的侧视图。
图11是图10中的锚定座的立体结构示意图。
图12是图10中的连接件的立体结构示意图。
图13是本申请一实施方式提供的锚定组件与锚定装置的连接示意图。
图14是图13中的锚定组件与锚定装置的分离示意图。
图15是图13中的锚定组件与锚定装置连接时的轴向剖视图。
图16是本申请一实施方式提供的锚定组件穿装于输送鞘管的远端的立体结构示意图。
图17是图16中XVII部分的放大示意图。
图18是输送鞘管推送间隔件的场景示意图。
图19是推送件推送间隔件的示意图。
图20是输送件穿过收线器的立体结构示意图。
图21是图20中收线器的外壳去除近端部分的立体结构示意图。
图22是绕线轴、限位柱、止转轮以及弹性件的立体结构示意图。
图23是收线器与调节装置远端连接的轴向剖视图。
图24至图27是本申请一实施方式提供的经导管缩环系统的使用过程示意图。
 本发明的实施方式
下面将结合本申请实施方式中的附图，对本申请实施方式中的技术方案进行清楚、完整地描述，显然，所描述的实施方式仅仅是本申请的一部分实施方式，而不是全部的实施方式。基于本申请中的实施方式，本领域普通技术人员在没有付出创造性劳动的前提下所获得的所有其他实施方式，都属于本申请保护的范围。
此外，以下各实施方式的说明是参考附加的图示，用以例示本申请可用以实施的特定实施方式。本申请中所提到的方向用语，例如，“上”、“下”、“前”、“后”、“左”、“右”、“内”、“外”、“侧面”等，仅是参考附加图示的方向，因此，所使用的方向用语是为了更好、更清楚地说明及理解本申请，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
需要说明的是，为了更加清楚地描述本申请提供的经导管缩环系统的结构，本申请在说明书中所述的限定术语“近端”及“远端”为介入医疗领域的惯用术语。具体而言，“远端”表示手术操作过程中远离操作人员的一端，“近端”表示手术操作过程中靠近操作人员的一端；将柱体、管体等一类物体的旋转中心轴的方向定义为轴向；周向为围绕柱体、管体等一类物体的轴线的方向；径向就是沿直径或半径的方向。
值得注意的是，无论“近端”、“远端”、“一端”、“另一端”、“第一端”、“第二端”、“初始端”、“末端”、“两端”、“头端”、“上端”、“下端”等词语中所出现的“端”，并不仅限于端头、端点或端面，也包括自端头、端点、或端面在端头、端点、或端面所属元件上延伸一段轴向距离和/或径向距离的部位。除非另有定义，本申请所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本申请在说明书中所使用的惯用术语只是为了描述具体实施方式的目的，并不能理解为对本申请的限制。
请参阅图1至图3，本申请提供一种经导管缩环系统1，可用于在二尖瓣瓣环或三尖瓣瓣环等心脏组织植入多个通过收紧线32串连的锚定组件34，通过收紧收紧线32缩小多个锚定组件34之间的间距，以直接缩小瓣环，从而实现对二尖瓣反流或三尖瓣反流的治疗。
在本申请中，经导管缩环系统1可包括锚定装置10、植入物30、输送装置50以及导引装置70。
请参阅图1，在一些实施方式中，导引装置70包括第一导引鞘管71及穿装在第一导引鞘管71中的第二导引鞘管72，第二导引鞘管72能够自第一导引鞘管71的远端伸出并贴合在瓣环上，进而建立从体外到心脏的介入通道。
优选地，第一导引鞘管71及第二导引鞘管72均为可调弯鞘管，使得导引装置70的远端可调整至贴合瓣环的角度，两个可调弯的导引鞘管可更好调节导引装置70远端的弯曲角度及方向。当然，在其他实施方式中，导引装置70可以只采用一个可调弯的导引鞘管。其中，可调弯的导引鞘管为现有技术中介入手术常用的导引装置，在此不作赘述。
请参阅图2及图3，在一些实施方式中，植入物30包括收紧线32以及多个锚定组件34，多个锚定组件34通过收紧线32连接并分别用于锚入瓣环。如图1所示，每一锚定组件34可拆卸连接于锚定装置10的远端，锚定装置10用于将锚定组件34锚入瓣环。
输送装置50用于将植入物30输送至瓣环处。如图1所示，输送装置50包括与收紧线32相互连接的输送件53，输送件53具有柔性且延伸至患者体外。如图2及图3所示，锚定组件34沿输送件53输送并穿装至收紧线32上，在多个锚定组件34锚入瓣环后，收紧线32调整多个锚定组件34的间距并与输送件53分离。这样，多个锚定组件34通过收紧线32串连并锚入瓣环沿周向的不同位置，收紧收紧线32缩小多个锚定组件34之间的间距，可实现缩环的目的。
可以理解的是，本申请提供的经导管缩环系统1中，通过设置与收紧线32可分离连接的输送件53，并通过输送件53将多个锚定组件34依次穿装至收紧线32上，使得收紧线32可选择合适的植入长度，从而不需要在体内对收紧线32进行裁剪，避免了产生线材上颗粒的脱落，缩环手术更安全。
需要说明的是，收紧线32的远端与用于锚入瓣环的第一个锚定组件34连接（见图4至图6），用于锚入瓣环的其他锚定组件34沿输送件53输送并穿装至收紧线32上。其中，收紧线32具有一定轴向长度且具有柔性，收紧线32的径向截面形状可以是圆形、扁圆形、矩形、方形或其他形状等；同样，输送件53也具有一定轴向长度且具有柔性，输送件53的径向截面形状也可以是圆形、扁圆形、矩形、方形或其他形状等；本申请对收紧线32及输送件53的径向截面形状不作具体的限定。
请参阅图1，输送装置50还包括输送鞘管51，锚定装置10穿装于输送鞘管51的内腔中，输送鞘管51用于将与锚定装置10的远端可拆卸连接的锚定组件34输送至瓣环处。输送鞘管51的远端部分具有柔性，输送鞘管51穿装在第二导引鞘管72的内腔中，通过调节导引装置70远端的弯曲角度即可带动输送鞘管51远端弯曲。
在使用经导管缩环系统1进行缩环时，先通过导引装置70建立从患者体外到心脏的介入通道，再将穿装有锚定装置10、锚定组件34的输送鞘管51，连同收紧线32及输送件53在导引装置70的第二导引鞘管72的内腔中沿轴向向远端移动，直至输送鞘管51抵顶于瓣环上，然后通过锚定装置10在输送鞘管51内驱动锚定组件34锚入瓣环。多个锚定组件34分别通过前述相同的步骤依次锚入瓣环沿周向的不同位置（如图2所示），通过收紧收紧线32以调整多个锚定组件34之间的间距，使多个锚定组件34相对聚拢（如图3所示），从而带动瓣环收缩，实现缩环的目的。
请参阅图1至图4，在一些实施方式中，锚定组件34包括用于锚入瓣环的锚定件340及设于锚定件340上的穿线结构。锚定件340穿装于输送鞘管51的远端内腔中。收紧线32的远端连接用于锚入瓣环的第一个锚定组件34的穿线结构，收紧线32的近端滑动穿过用于锚入瓣环的其他锚定组件34的穿线结构。这样，收紧线32通过穿线结构与锚定件340连接，从而将多个锚入瓣环的锚定组件34串连在一起，收紧收紧线32即可缩小多个锚定组件34之间的间距，进而实现缩环。
在一些实施方式中，收紧线32的硬度大于或等于输送件53的硬度，优选大于输送件53的硬度。这样，收紧线32的硬度较大不易断裂，在植入物30植入瓣环后，收紧线32可稳定串连多个锚定组件34，避免因瓣叶活动的长时间作用导致收紧线32断裂。
为保证植入安全性，收紧线32和输送件53均可采用具有生物相容性的金属材料或者高分子材料制成，尤其是收紧线32，金属材料包括但不限于具有显影性的钨、镍钛、钽、金及其合金中的至少一种，高分子材料包括但不限于聚乙烯、聚酰胺、聚丙烯、聚氨酯及超高分子量聚乙烯中的至少一种。具体地，在一些实施方式中，收紧线32优选采用生物相容性良好的金属材料制成，输送件53采用具有生物相容性的高分子材料制成。由于收紧线32所采用的金属材料具有显影性，在所有锚定组件34的植入过程中，通过显影设备即可看到收紧线32的状态和位置，有利于降低术中发生绕线的风险，提升手术成功率。
请参阅图2，在一些实施方式中，输送件53的远端连接至收紧线32的近端，输送件53的近端延伸至患者体外。输送件53与收紧线32通过端对端实现连接，尽量避免收紧线32和输送件53在径向上并排，减小收紧线32和输送件53在第二导引鞘管72内或输送鞘管51占用的空间。当然，在其他实施方式中，输送件53和收紧线32也可以不通过端对端的方式实现连接，对此不作限定。
请参阅图4及图5，在一些实施方式中，收紧线32的近端形成第一环圈321，输送件53穿过第一环圈321后对折使输送件53的远端与收紧线32的近端U型连接。在该实施方式中，输送件53可为一根包括两个头端的细长线，输送件53与收紧线32U型连接后可呈双线结构。当输送件53的两个头端不闭合时，植入物30完成缩环（即收紧线32完成调整多个锚定组件34之间的间距）后，可将直接将输送件53从第一环圈321中抽离，以使输送件53与收紧线32分离并撤出患者体外，不需要对输送件53进行裁剪。当输送件53的两个头端闭合时，植入物30完成缩环后，可在体外裁剪输送件53使输送件53呈非闭合的双线结构，即可撤出输送件53。
在图4的示例中，收紧线32为双线结构。收紧线32可为一根包括两个头端的细长线，收紧线32的其中一头端穿过用于锚入瓣环的第一个锚定组件34的穿线结构之后形成U型连接，收紧线32的两个头端端通过压管33固定，使收紧线32呈闭合的双线结构。收紧线32于压管33的两侧分别形成位于近端的第一环圈321和位于远端第二环圈322，输送件53的远端与收紧线32近端的第一环圈321形成U型连接，第一个锚定组件34的穿线结构与收紧线32远端的第二环圈321形成U型连接。
在图5的示例中，收紧线32为单线结构。收紧线32可为一根包括两个头端的细长线，收紧线32的其中一头端穿过用于锚入瓣环的第一个锚定组件34的穿线结构之后形成U型连接，并通过压管33固定使收紧线32的远端形成第二环圈322，收紧线32的另一头端形成位于其近端的第一环圈321后通过另一压管33固定，第一环圈321用于和输送件53的远端形成U型连接，第二环圈322用于和第一个锚定组件34的穿线环347形成U型连接。可以理解的是，单线结构的收紧线32与锚定组件34发生绕线、压线的风险降低，手术更安全。
需要说明的是，压管33可以采用夹头等其他固定件代替。再者，收紧线32的两个头端也可以通过粘接或者打结的方式形成第一环圈321和第二环圈322，对此不作限定。收紧线32可以由单股丝线制成或者多股丝线编织制成，优选由多股丝线编织制成，使得收紧线32不易断裂。
请参阅图6，在一些实施方式中，收紧线32的近端与远端之间的部分套设有柔性管37。其中，柔性管37可以是但不限于PET热缩管，收紧线32可以是双线结构也可以是单线结构。可以理解的是，通过在收紧线32的两端之间的部分套设柔性管37，同样可以降低收紧线32与锚定组件34发生绕线、压线的风险，使手术更安全。
请参阅图7，在一些实施方式中，收紧线32为柔顺度较好的金属丝束管，金属丝束管由多股金属丝编织而成，金属丝可以是但不限于镍钛丝、钨丝等。金属丝束管在编织时与用于锚入瓣环的第一个锚定组件34的穿线结构连接，使得金属丝束管的远端形成有第二环圈322，金属丝束管的近端弯曲形成第一环圈321并用压管33固定。可以理解的是，采用金属丝束管作为收紧线32，只需一个压管33即可形成具有第一环圈321和第二环圈322的单线结构，减少了压管33的数量。金属丝束管的近端也可通过编织形成第一环圈321。可选地，金属丝束管的近端与远端之间的部分也可以套设有柔性管37，从而进一步降低收紧线32与锚定组件34发生绕线、压线的风险，使手术更安全。
需要说明的是，上述实施方式中，收紧线32上的压管33无法通过锚定组件34的穿线结构。压管33可采用但不限于不锈钢材料制成，压管33通过压线钳进行挤压以将收紧线32的一端进行固定。优选地，压管33整体被覆膜包裹，减少瓣环等心脏组织被压管33损伤的风险。
此外，在一些实施方式中，收紧线32的近端与输送件53的远端之间可以采用但不限于螺纹连接、卡合连接等方式可拆卸连接。
具体地，在一些示例中，收紧线32的近端设有第一螺纹部，输送件53的远端设有第二螺纹部，第一螺纹部与第二螺纹部螺纹连接，以使输送件53的远端与收紧线32的近端可拆卸连接。需要说明的是，当输送件53为柔性较好的高分子线时，可通过一工具卡住第二螺纹部进行旋转，使第二螺纹部与第一螺纹部解除连接，进而使输送件53和收紧线32分离。当输送件53为具有一定强度的金属丝时，可直接旋转输送件53即可使第二螺纹部与第一螺纹部解除连接，进而使输送件53和收紧线32分离。
在另一些示例中，收紧线32的近端设有卡槽，输送件53的远端设有与卡槽适配的卡扣，卡扣与卡槽卡合连接，以使输送件53的远端与收紧线32的近端可拆卸连接。可以理解的是，向近端牵拉输送件53，使卡扣自卡槽中脱离，即可使输送件53和收紧线32分离。
请参阅图8，优选地，在一些实施方式中，输送装置50还包括连接于输送件53近端的引线件55，引线件55的近端具有锥形头部。在图8的示例中，输送件53为双线结构，引线件55与输送件53的近端固定连接，使得输送件53呈闭合的双线结构。具体地，将输送件53的其中一头端穿过收紧线32近端的第一环圈321后对折，然后在近端将输送件53的两个头端穿入到引线件55中进行挤压固定。可以理解的是，输送件53的近端连接具有锥形头端的引线件55，使得输送件53易于穿过锚定组件34的穿线结构。其中，引线件55可以采用具有生物相容性的金属材料或者高分子材料制成。
请参阅图9及图10，在一些实施方式中，锚定件340包括锚定部341及固定连接于锚定部341近端的锚定座343。锚定组件34的穿线结构包括连接件345及穿线环347。连接件345活动套设于锚定座343上，穿线环347活动连接于连接件345，收紧线32连接穿线环347而与锚定组件34连接。
可以理解的是，锚定座343用于与锚定装置10的远端可拆卸连接，锚定部341用于锚入瓣环以使锚定组件34植入在瓣环上。具体地，如图9及图10所示，锚定部341为具有尖端的螺旋状锚钉，易于锚入瓣环中，且锚定组件34植入后不易脱落。当然，锚定部341也可以是具有使锚定部341能够与组织接合并基本上固定到组织的另一种合适的构造，例如但不限于倒钩，钩子，尖齿等。且为了便于输送，所述倒钩、钩子至少部分由具有形状记忆功能的材料制成。
在其他实施方式中，连接件345可活动套设于锚定部341的近端，锚定部341设计为螺旋状锚钉或者在锚定部341上设计限位部件使得连接件345不从锚定件340上掉落即可。当然，锚定组件34的穿线结构也可以只包括一个套设于锚定件340上的穿线环347，优选地，穿线环347可以活动套设于锚定座343上。穿线结构还可以是开设于锚定件340上的穿线孔，优选地，穿线孔可以设置于锚定座343上。
请参阅图11，锚定座343包括支撑部3433，连接件345活动套设于支撑部3433上。为了避免连接件345自支撑部3433上掉落，锚定座343还包括分别连接于支撑部3433的近端和远端的第一支撑体3432和第二支撑体3434，第一支撑体3432和第二支撑体3434的外径相等且均大于支撑部3433的外径。第一支撑体3432、支撑部3433及第二支撑体3434大致呈“工”字型结构，形成一环绕支撑部3433的连接槽3435。如图9及图10所示，连接件345套设于支撑部3433上时，连接件345至少部分收容于连接槽3435中。
进一步地，锚定座343还包括设于第一支撑体3432近端的第一连接部3431及设于第二支撑体3434远端的插接部3437。第一连接部3431用于与锚定装置10的远端可拆卸连接。插接部3437用于连接锚定部341的近端。具体地，插接部3437开设有沿锚定件340的轴向延伸的插接孔，锚定部341的近端插接于该插接孔内并通过焊接或胶接固定（见图9及图10）。在其他实施方式中，锚定部341可以直接通过焊接等方式固定连接于插接部3437，插接部3437不必开设插接孔。锚定部341也可以直接通过焊接等方式固定连接于第二支撑体3434的远端，从而不必设置插接部3437。
请参阅图12，在一些实施方式中，连接件345开设有装配孔3452及连接孔3454。锚定座343穿装于装配孔3452中，具体地，连接件345通过装配孔3452活动套设于锚定座343的支撑部3433上。连接孔3454用于活动连接穿线环347。如图9及图10所示，锚定座343的支撑部3433穿装于连接件345的装配孔3452中，使得连接件345套设于支撑部3433上。穿线环347穿过连接件345的连接孔3454，从而与连接件345扣接，实现穿线环347与连接件345活动连接。在其他实施方式中，连接件345可为连接环，连接环直接与穿线环347扣接。
需要说明的是，装配孔3452的直径大于支撑部3433的直径且小于锚定座343的最大外径（即第一支撑体3432和第二支撑体3434的外径），使得连接件345能够活动套设于锚定座343的支撑部3433上且不会从锚定座343上脱落。
在一些实施方式中，连接件345可绕锚定件340的中心轴Z（见图9）转动360度，即连接件345具有绕锚定件340的中心轴Z转动的转动自由度。进一步地，连接槽3435的轴向宽度p（见图11）可大于装配部3451的轴向厚度q（见图12），优选为装配部3451的轴向厚度q的2-3倍，使得连接件345可沿锚定件340的轴向移动，即连接件345还具有沿锚定件340的中心轴Z（见图9）移动的平动自由度。因此，在一些实施方式中，连接件345具有两个自由度，包括绕锚定件340的中心轴Z转动的转动自由度，和沿锚定件340的中心轴Z移动的平动自由度。当然，在其他实施方式中，连接件345可具有一个自由度，即绕锚定件340的中心轴Z转动的转动自由度。
请再次参阅图9及图10，在一些实施方式中，穿线环347具有两个自由度，包括绕自身中心轴X转动的转动自由度（可转动360度）及绕平行于锚定件340的中心轴Z的径向轴线Y左右偏转的转动自由度。其中，穿线环347绕径向轴线Y左右偏转的转动自由度均可以达到90度（即可向左偏转90度、可向右偏转90度）。
需要说明的是，穿线环347可以为圆环或椭圆环，其轴向截面的形状也可以为圆形或椭圆形。连接件345的装配孔3452和连接孔3454可以为圆孔或椭圆孔。优选地，穿线环347为圆环，且其轴向截面形状也为圆形；连接件345的装配孔3452和连接孔3454均为圆孔。
如上所述，在一些实施方式中，连接件345具有绕锚定件340的中心轴Z转动的转动自由度及沿锚定件340的中心轴Z移动的平动自由度，穿线环347具有绕自身中心轴X转动的转动自由度及绕径向轴线Y左右偏转的转动自由度。可以理解的是，多个锚定组件34锚入瓣环后，由于连接件345可绕锚定件340的中心轴Z转动，使得扣接于连接件345的穿线环347可在收紧线32收紧时的拉紧力作用下运动到配合收紧线32收紧后的状态，穿线环347的穿线方向可沿着瓣环的周向，使得收紧线32的收缩过程阻力大大减小，收紧线32不存在弯折的情况且收缩稳定顺畅。再者，连接件345可以沿锚定件340的轴向移动，当多个锚定组件34的锚定部341的锚入深度不一致时，收紧线32可牵拉使连接件345沿轴向上下移动，进一步使收紧线32减少弯折，收紧线32尽可能分布于同一个平面上收缩稳定顺畅。而穿线环347自身可活动，配合连接件345调整方向减小收紧线32的收缩阻力的效果更好。此外，由于收紧线32在收紧方向上所受阻力大大减小，收紧力减小且收紧力分布在每个锚定组件34上的作用力更加均匀，相应的单个锚定组件34所受作用力也大大减小，减小了锚定组件34对瓣膜的作用力，降低了瓣膜受到损伤的风险，同时避免出现单个锚定组件34所受收紧力占比较大的情况，降低了锚定组件34脱落的风险，植入更安全。
需要说明的是，为保证植入后的安全性，锚定组件34整体由具有良好生物相容性的材料制成，包括但不限于金属材料（例如不锈钢）或高分子材料（例如PEEK、PET）。其中，锚定座343和锚定部341优选硬度较高的不锈钢材料制成。连接件345和穿线环347均可采用不锈钢材料或高分子材料（例如PEEK、PET）制成，优选具有柔性的高分子材料制成，可被扭转变形，从而更有利于其转动。
请参阅图13至图15，锚定组件34可拆卸连接于锚定装置10的远端。在一些实施方式中，锚定装置10包括驱动管12及穿装在驱动管12中的连接杆14，驱动管12的远端设有与锚定座343的第一连接部3431可拆卸连接的第二连接部122，连接杆14轴向穿设于配合连接的第一连接部3431及第二连接部122中以使锚定组件34与锚定装置10保持连接，驱动管12用于驱动锚定组件34（即锚定件340）锚入瓣环。
其中，第一连接部3431和第二连接部122分别为设置于锚定座343近端和驱动管12远端的S型卡扣，第一连接部3431和第二连接部122均具有一内腔。如图15所示，第一连接部3431和第二连接部122对接时，锚定座343和驱动管12各自的S型卡扣扣合，二者的内腔连通，穿装于驱动管12内的连接杆14的远端自驱动管12的远端伸出并插入第一连接部3431和第二连接部122的内腔中，从而限制第一连接部3431和第二连接部122的分离，使得锚定组件34与驱动管12保持连接，通过旋转驱动管12即可带动锚定组件34旋转，从而使锚定部341锚入瓣环。可以理解的是，当连接杆14的远端自第一连接部3431和第二连接部122对接扣合处撤离时，第一连接部3431和第二连接部122即可分离，从而实现锚定组件34与驱动管12的分离。锚定装置10可以采用金属材料或者高分子材料制成，优选硬度较高的金属材料例如不锈钢制成。
在其他实施方式中，第一连接部3431和第二连接部122可以是卡块与卡槽的配合结构。锚定装置10也可以是驱动管12与套设于驱动管12的外部的连接管组成，该连接管的远端套设于配合连接的第一连接部3431和第二连接部122的外部，同样可以起到限制第一连接部3431和第二连接部122分离的作用。
请参阅图16及图17，在一些实施方式中，输送鞘管51的管壁自远端端部开设有向近端延伸的通槽512，通槽512连通输送鞘管51的内腔，且通槽512的远端具有开口。经导管缩环系统还包括止挡部59，止挡部59设于输送鞘管51的远端，止挡部59用于封闭通槽512的远端开口以将锚定件340的远端与所述收紧线隔开。
可以理解的是，通过在输送鞘管51的远端开设通槽512并设置止挡部59，在输送装置50用于输送收紧线32及锚定组件34时，锚定件340位于输送鞘管51的内腔，收紧线32自其与锚定组件34的穿线结构相连处起向远端延伸的部分位于输送鞘管51的外部，从而将锚定件340的远端与收紧线32隔开，可以防止收紧线32缠绕锚定件340，避免出现绕线的问题，有利于锚定组件34的顺利植入。具体地，通槽512呈“一”字型延伸至输送鞘管51的远端端部，使通槽512的远端具有开口，通槽512的近端封闭。当然，通槽512也可延伸至输送鞘管51的近端端部。
请再次参阅图12及图17，在一些实施方式中，连接件345远离锚定座343的一侧凸设有卡持端3455，卡持端3455的径向宽度与输送鞘管51的通槽512的径向宽度适配，当锚定组件34穿装于输送鞘管51的远端时，卡持端3455卡持于通槽512中。这样，可以防止输送锚定组件34的过程中，连接件345转动而带动穿线环347转动，从而保证锚定组件34输送稳定顺畅。需要说明的是，当锚定组件34相对于输送鞘管51移动时，卡持端3455随着锚定组件34整体的移动而在通槽512中移动。
在一些实施方式中，锚定组件34的穿线结构至少部分自通槽512露出而位于输送鞘管51的外部，收紧线32与锚定组件34的穿线结构位于输送鞘管51外部的部分连接。由此，收紧线32及其近端连接的输送件53整体位于输送鞘管51的外部，输送件51的近端通过第二导引鞘管72的内腔延伸至患者体外。
在图16的示例中，穿线环347至少部分自通槽512露出而位于输送鞘管51的外部，收紧线32与穿线环347位于输送鞘管51外部的部分连接。这样，可减小输送鞘管51的径向尺寸。可以理解的是，通槽512的径向宽度大于穿线环347的轴向厚度（即穿线环347沿轴向的厚度），使得穿线环347可至少部分自通槽512露出，收紧线32连接穿线环347后可整体位于输送鞘管51的外部。进一步地，通槽512的径向宽度小于穿线环347的最大外径，避免通槽512过宽，穿线环347在锚定组件34的输送过程中易掉入输送鞘管51的内腔中。通槽512的轴向长度大于穿线环347的最大外径，以使整个穿线环347能够自通槽512露出，穿线环347整体位于输送鞘管51的外部，穿线空间更大，有利于收紧线32穿过穿线环347，连接操作简便。优选地，通槽512的轴向长度大于支撑部3433的近端至锚定部341的远端之间的轴向距离H（见图15），使得整个锚定件340均可收容于输送鞘管51的内腔中，锚定件340与收紧线32被完全隔绝于输送鞘管51的内外两侧，更有利于避免锚定组件34在输送及植入过程中出现绕线的问题。
在其他实施方式中，锚定组件34的穿线结构也可以整体位于输送鞘管51的内腔中，收紧线32穿过通槽512进入输送鞘管51的内腔与锚定组件34的穿线环347连接。由此，收紧线32自其与锚定组件34的穿线结构相连处起向远端延伸的部分位于输送鞘管51的外部，而收紧线32自其与锚定组件34的穿线结构相连处起向近端延伸的部分、以及收紧线32近端连接的输送件53位于输送鞘管51的内腔中，输送件53的近端通过输送鞘管51的内腔延伸至患者体外。
请再次参阅图16及图17，止挡部59活动设于输送鞘管51的远端，止挡部59的近端沿输送鞘管51的轴向延伸，止挡部59的远端适配输送鞘管51的周向且在不受外力作用时封闭通槽512的远端开口。具体地，止挡部59可为挡丝，挡丝至少远端部分具有形状记忆功能，挡丝的远端部分定型为沿输送鞘管51的周向延伸的弧状，优选为圆弧状。在自然状态下，即挡丝不受外力作用的状态下，挡丝的远端封闭通槽512的远端开口。当将锚定组件34穿装于输送鞘管51时，向近端牵拉挡丝打开通槽512的远端开口以在输送鞘管51穿装锚定组件34，使锚定组件34的穿线环347进入通槽512中。当输送锚定组件34时，释放对挡丝的牵拉力，挡丝的远端由于自身的记忆功能作用下回到原位而再次封闭通槽512的远端开口。这样，由于挡丝的止挡，锚定组件34的穿线环347无法自通槽512的远端开口滑出，从而能够防止锚定组件34在输送过程中脱离输送鞘管51，保证锚定件340在输送过程中始终处于输送鞘管51中，避免收紧线32与锚定件340发生缠绕。
请参阅图2及图18，在一些实施方式中，植入物30还包括至少一个间隔件36，间隔件36沿输送件53输送并穿装至收紧线32上，且间隔件36位于两个锚定组件34之间。可以理解的是，在两个锚定组件34之间设置间隔件36，可以防止收紧线32过度收紧导致相邻的两个锚定组件34之间的距离过短而损伤瓣环，同时间隔件36可以起到缓冲作用，分散锚定组件34受到的收紧力，保证锚定组件34植入稳定。其中，间隔件36为具有一定长度的筒状件，优选采用具有生物相容性材料制成。间隔件36可包裹有覆膜，以减少瓣环等心脏组织被间隔件36损伤的风险。
可选地，植入物30的多个锚定组件34中的任意相邻的两个锚定组件34之间可以设置一间隔件36（如图2及图3所示），也可以是每间隔两个或者两个以上的锚定组件34设置一间隔件36，对此不作限定。
请参阅图19，在一些实施方式中，经导管缩环系统1还包括用于推送间隔件36的推送件90。具体地，推送件90的远端开设有用于供输送件53的近端活动穿过的导引孔92。间隔件穿装于输送件53上后，输送件53穿过推送件90的导引孔92，推送件90沿输送件53推送间隔件36进入导引装置70的第二导引鞘管72中，输送鞘管51穿装于第二导引鞘管72中以在第二导引鞘管72中推送间隔件36，以使间隔件36沿输送件53穿装于收紧线32上。
可以理解的是，在瓣环植入第一个锚定组件34后，撤出输送鞘管51及锚定装置10，在输送件53的近端穿装间隔件36并将输送件53沿穿线方向a穿过推送件90的导引孔92后，推送件90顺着输送件53沿推送方向b推送间隔件36进入导引装置70的第二导引鞘管72中。然后，取出推送件90，将穿装于输送鞘管51的第二个锚定组件34通过其露于输送鞘管51外部的穿线环347穿装于输送件53上，输送鞘管51进一步穿装于第二导引鞘管72中，间隔件36位于输送鞘管51的远端一侧。由此，输送鞘管51在第二导引鞘管72内沿轴向向远端移动，即可沿输送件53输送以将间隔件36及锚定组件34穿装于收紧线32上，并将间隔件36推送至瓣环处，然后锚定装置10将第二个锚定组件34推出输送鞘管51并将第二个锚定组件34锚入瓣环，使得间隔件36位于两个锚定组件34之间。重复同样的步骤，依次将多个锚定组件34植入瓣环中，同时间隔件36依次穿插在每两个或多个锚定组件34之间。其中，相邻的两个锚定组件34的距离需要大于间隔件36的轴向长度。
请再次参阅图1及图3，在一些实施方式中，经导管缩环系统1还包括调节装置80，植入物30还包括收线器38。调节装置80用于输送及控制收线器38。收线器38用于调节收紧线32以调整多个锚定组件34之间的间距、以及在调整好多个锚定组件34之间的间距后锁定收紧线32。
具体地，在瓣环植入多个锚定组件34及间隔件36后，沿输送件53将收线器38穿装在收紧线32上，然后利用收线器38收紧收紧线32并锁定收紧线32使收紧线32在瓣环上保持一定长度，即可撤出输送件53，释放收紧线32，完成缩环以减轻血液反流。可以理解的是，通过输送件53实现收线器38穿装于收紧线32上并且能够顺利释放收紧线32，不需要提前将收线器38植入患者体内，简化手术过程，降低手术难度，缩短手术时间。
需要说明的是，输送件53的远端与收紧线32的近端连接，输送件53的近端延伸至患者体外，锚定组件34、间隔件36及收线器38可通过延伸至体外的输送件53输送以穿装至收紧线32上，使得收紧线32可选择合适的植入长度，通过收线器38调节收紧线32在瓣环上的长度并锁紧，无需对收紧线32进行裁剪。
请一并参阅图20至图23，在一些实施方式中，收线器38包括壳体381和可转动地设置于壳体381内的绕线轴383。收线器38向输送件53的远端移动以使收紧线32的近端活动地穿过壳体381及绕线轴383。绕线轴383相对于壳体381转动以卷绕收紧线32，绕线轴383停止转动时，收紧线32被锁紧于绕线轴383与壳体381之间的径向空间内。
可以理解的是，通过控制绕线轴383相对壳体381转动可卷绕收紧线32，使得收紧线32不断收紧而对瓣环进行缩环，直至血液反流减弱或者消失即可停止转动绕线轴383，此时收紧线32被锁紧于绕线轴383与壳体381之间的径向空间内，收紧线32在瓣环上保持一定的长度。通过收线器38卷绕锁定收紧线32，收紧线32的锁紧效果好。再者，如果经过一段时间，患者的瓣环又出现扩大导致反流复发，可直接控制收线器38进一步卷绕收紧线32缩小瓣环以使反流减弱或者消失，避免二次手术对患者造成较大的伤害。其中，收线器38可采用具有生物相容性的材料制成，例如不锈钢，对此不作限定。
需要说明的是，收紧线32在绕线轴38上至少卷绕三圈，每圈收紧线32之间的摩擦力可抵消瓣叶活动产生的拉力，保证收紧线32不被拉动，收紧线32在瓣环上保持一定的长度。
具体地，壳体381包括底壳3812和外壳3814。外壳3814的近端及远端均具有开口，底壳3812固定连接于外壳3814的远端以形成安装空间3816。收线器38还包括限位柱385、止转轮387和弹性件389。限位柱385、弹性件389、止转轮387、绕线轴383设置于壳体381的安装空间3816内。
如图21及图22所示，绕线轴383沿其径向设有通孔3832，外壳3814在绕线轴383的两侧设有两个线孔3818，两个线孔3818均连通绕线轴383的通孔3832。将收线器38穿装于输送件53上时，输送件53先自一个线孔3816穿入壳体381的安装空间3816中，然后穿过绕线轴383的通孔3832，再从另一个线孔3818穿出壳体381。优选地，两个线孔3818的中轴线与通孔3832的中轴线处于同一平面，可转动绕线轴383使通孔3832的中轴线与两个线孔3818的中轴线共线，这样有利于输送件53顺畅地穿过两个线孔3818及通孔3832，以便将收线器38输送至收紧线32上。
如图22及图23所示，限位柱385的远端与底壳3812固定连接。止转轮387套设于限位柱387上，且可沿限位柱385轴向移动。止转轮387的近端面沿周向环设若干第一斜齿3871，绕线轴383的远端面沿周向环设若干第二斜齿3831，绕线轴383套设于限位柱385上，使第二斜齿3831可与第一斜齿3871配合单向转动。弹性件389位于止转轮387与底壳3812之间，其一端抵持于底壳3812，另一端抵持止转轮387，弹性件389用于向止转轮387提供弹力，使得止转轮387的第一斜齿3871贴合绕线轴383的第二斜齿3831。当绕线轴383相对壳体381及止转轮387正转时，第二斜齿3871在第一斜齿3831上打滑使止转轮387向远端移动，当绕线轴383相对止转轮387转过一个斜齿的角度后，止转轮387受到弹性件389给与的弹力后会向近端移动，使得第一斜齿3831和第二斜齿3871重新贴合，绕线轴383可继续相对壳体381及止转轮387转动。当要反向转动绕线轴383时，第二斜齿3871无法使止转轮387向远端移动，第二斜齿3871无法越过任何一个第一斜齿3831导致绕线轴383无法反转。因此，当绕线轴383停止转动时，收紧线32即被锁紧于绕线轴383与壳体381之间的径向空间内。其中，弹性件389可以是但不限于弹簧、管状弹片及弹性波纹管等。
请参阅图20至图22，绕线轴383的远端面还设有一与限位柱385的近端配合的凹槽（图中未标示），限位柱385的近端部分收容于绕线轴383远端的凹槽内，且限位柱385的近端面与绕线轴383的远端面接触，从而与外壳3814的近端共同限制绕线轴383在安装空间3816中的轴向位移，使得绕线轴383只能转动。止转轮387的近端还设有限位凸台3873，外壳3814的远端对应设有限位槽3813，限位凸台3873卡设于对应的限位槽3813中，可以限制止转轮387发生转动，使止转轮387只能沿限位柱385的轴向移动。
在其他实施方式中，在瓣环植入多个锚定组件34及间隔件36后，牵拉收紧线32进行缩环以使血液反流减弱或消失后，可沿输送件53输送锁钉以对收紧后的收紧线32进行锁结，使收紧线32保持收紧后的状态，即可将输送件53撤出。
请一并参阅图1、图20及图23，在一些实施方式中，调节装置80包括由内至外套设的螺纹杆82、旋转管84及外鞘管86。其中，外鞘管86与收线器的壳体381卡接以限制壳体381转动；旋转管84用于与绕线轴383的近端卡接；螺纹杆82用于与绕线轴383螺纹连接而抵压旋转管84使旋转管84与绕线轴383保持连接。因此，通过转动旋转管84就可带动绕线轴383转动以卷绕收紧线32将收紧线32收紧。
在一些实施方式中，壳体381的外壳设有卡槽3811，外鞘管86的远端设有与卡槽3811对应的卡爪862，通过卡爪862与卡槽3811的配合，外鞘管86与壳体381实现连接。绕线轴383的近端自外壳3814的近端开口伸出，绕线轴383的近端沿其轴向设有螺纹孔。旋转管84的内壁凸设有第一凸台842，螺纹杆82的外壁凸设有第二凸台822。旋转管84与绕线轴383卡接后，螺纹杆82与螺纹孔螺接，即螺纹杆82与绕线轴383螺接，使第一凸台842抵压于绕线轴383与第二凸台822之间，旋转管84与绕线轴383保持连接。此时，外鞘管86限制壳体381转动，转动旋转管84就可带动螺纹杆82及绕线轴383同步转动，从而绕线轴383相对壳体381转动而卷绕收紧线32而将收紧线32收紧，实现缩环。
需要说明的是，经导管缩环系统1包含的锚定装置10、输送装置50、导引装置70及调节装置80还分别具有相应的控制手柄，其结构与现有技术中的手柄结构基本类似，对此不作赘述。
下面将结合图2、图3及图24至图27，以经导管缩环系统1应用于二尖瓣瓣环成形术为例说明本申请实施方式的经导管缩环系统1的使用过程及工作原理。其中，手术路径为：经股静脉-下腔静脉-右心房（RA）-房间隔（AS）-左心房（LA）-二尖瓣（MV）瓣环。
第一步，经股静脉穿刺，通过导丝（图未示出导丝及房间隔穿刺装置等器械）建立股静脉-下腔静脉-右心房-房间隔-左心房-二尖瓣瓣环的轨道。
第二步，如图24所示，将导引装置70沿导丝送入，直至其远端穿过卵圆孔到达左心房并送至瓣环附近后，撤出导丝。
第三步，如图25所示，第一个锚定组件34的穿线环347与收紧线32的远端连接，收紧线32的近端与输送件53的远端可拆卸连接。首先，将第一个锚定组件34装配于输送鞘管51的远端并与锚定装置10可拆卸连接，其中，第一个锚定组件34的穿线环347的部分自通槽512露出，收紧线32及输送件53位于输送鞘管51的外部；然后，将输送鞘管51在导引装置70内沿轴向向远端移动至其远端抵顶瓣环预定的治疗位点。其中，在锚定组件34装配于输送鞘管51远端的过程中，需要牵拉挡丝朝近端移动以打开通槽512的远端开口，使穿线环347进入通槽512中，待穿线环347进入通槽512后释放挡丝，挡丝复位以封闭通槽512的远端开口。
第四步，如图26所示，牵拉挡丝，使得挡丝朝近端移动以打开通槽512的远端开口，然后再利用穿装于输送鞘管51内腔的锚定装置10将第一个锚定组件34植入二尖瓣的瓣环上。如图27所示，朝近端后撤输送鞘管51，使第一个锚定组件34完全脱离输送鞘管51，解除锚定装置10与第一个锚定组件34的连接。
第五步，在植入第一个锚定组件34后，撤出锚定装置10及输送鞘管51，将间隔件36通过输送件53导入导引装置70内；然后重复第三步和第四步，将输送件53近端穿过第二个锚定组件34的穿线环347（第二个锚定组件34已经与锚定装置10的远端连接并穿装于输送鞘管51）并在导引装置70中推送输送鞘管51，通过输送鞘管51的向前推送将第一个间隔件36和第二个锚定组件34沿输送件53输送以穿装于收紧线32上并输送至瓣环附近，间隔件36介于第一个锚定组件34和第二个锚定组件34之间。在超声和数字减影血管造影术（DSA）下，根据病变瓣环的尺寸，控制导引装置70和输送鞘管51调整第二个锚定组件34的位置，植入第二个锚定组件34。第二个锚定组件34与第一个锚定组件34的距离需要大于间隔件36的轴向长度。
第六步，重复第五步，依次从二尖瓣的前三角区沿后瓣环至后三角区或者反向，将锚定组件34及间隔件36依次植入，使得锚定组件34和间隔件36均匀分布于瓣环上（如图2所示），在植入足够数量的锚定组件34后，撤出锚定装置10及输送鞘管51。
第七步，首先，将收线器38连接到调节装置80的远端，并将输送件53近端穿过收线器38，沿输送件53将收线器38送至收紧线32上；然后，正转调节装置80的旋转管84，使收线器38的绕线轴383调节收紧线32在瓣环上的长度以缩小多个锚定组件34之间的间距，从而带动瓣环收缩。在达到良好的缩环效果后，旋转管84停止转动，收线器38锁紧收紧线32，再反转螺纹杆82，使收线器38与调节装置80脱离以便于撤出调节装置80，使植入物30留置于瓣环上（如图3所示），完成缩环手术。
需要说明的是，在锚定组件34的植入过程中，存在较低概率的压线情况，此时，可以结合DSA和超声设备，反向转动锚定装置10的驱动管12，拧松锚定组件34，使得收紧线32脱出，然后再重新拧紧锚定组件34，进行植入即可。
可以理解的是，本申请提供的经导管缩环系统1也可以应用于三尖瓣瓣环的缩环，对此不作赘述。此外，需要说明的是，本申请提供的经导管缩环系统1，还可以用于左心室壁或右心室壁等心脏组织植入多个通过收紧线32串连的锚定组件34，通过收紧收紧线32缩小多个锚定组件34之间的间距，以通过缩窄心室使心室减容达到缩小瓣环的目的，从而实现对二尖瓣反流或三尖瓣反流的治疗。植入物30除了如图示的实施方式直接植入在心房侧的瓣环上，还可以植入在瓣环下，即植入物30还可以植入在二尖瓣瓣环下的左心室壁或三尖瓣瓣环下的右心室壁。其中，植入物30植入在左心室壁上尤其适用于治疗左心室功能异常导致的心脏衰竭以及功能性二尖瓣反流。导引装置70可以从股动脉穿刺，逆行通过主动脉瓣进入左心室，通过输送装置50及锚定装置10将植入物30植入在左心室壁上，收紧线32收紧后直接抑制左心室扩张而达到缩小二尖瓣瓣环的目的，这种环下成形可以保留二尖瓣的自然结构。也即是说，本申请的经导管缩环系统1除了用于在瓣环成形术中收缩瓣环，还可用于在心室减容术中减小心室容积，其具体的使用过程与上述二尖瓣瓣环成形术的使用过程基本类似，在此不作赘述。
综上，本申请的经导管缩环系统1可用于在二尖瓣瓣环、三尖瓣瓣环、左心室壁、右心室壁等心脏组织上锚入多个通过收紧线32串连的锚定组件34，通过收紧线32缩小多个锚定组件34之间的间距，从而实现对二尖瓣反流、三尖瓣反流或左心室功能异常导致的心脏衰竭的治疗。
在本说明书的描述中，参考术语“一些实施方式”、“示意性实施方式”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施方式或示例描述的具体特征、结构、材料或者特点包含于本申请的至少一个实施方式或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施方式或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施方式或示例中以合适的方式结合。
尽管已经示出和描述了本申请的实施方式，本领域的普通技术人员可以理解：在不脱离本申请的原理和宗旨的情况下可以对这些实施方式进行多种变化、修改、替换和变型，本申请的范围由权利要求及其等同物限定。

Claims (25)

  1. 一种经导管缩环系统，其特征在于，包括多个锚定组件、相互连接的收紧线及输送件，所述输送件具有柔性且延伸至体外，所述锚定组件沿所述输送件输送并穿装至所述收紧线上，在所述多个锚定组件锚入心脏组织后，所述收紧线调整所述多个锚定组件的间距并与所述输送件分离。
  2. 如权利要求1所述的经导管缩环系统，其特征在于，所述输送件的远端连接至所述收紧线的近端，所述输送件的近端延伸至体外。
  3. 如权利要求2所述的经导管缩环系统，其特征在于，所述收紧线的近端形成有第一环圈，所述输送件穿过所述第一环圈后对折使所述输送件的远端与所述收紧线的近端U型连接。
  4. 如权利要求3所述的经导管缩环系统，其特征在于，所述收紧线为双线结构或单线结构。
  5. 如权利要求4所述的经导管缩环系统，其特征在于，所述收紧线由多股丝线编织制成。
  6. 如权利要求4所述的经导管缩环系统，其特征在于，所述收紧线的近端与远端之间的部分套设有柔性管。
  7. 如权利要求2所述的经导管缩环系统，其特征在于，所述收紧线的近端与所述输送件的远端之间可拆卸连接。
  8. 如权利要求7所述的经导管缩环系统，其特征在于，所述收紧线的近端设有第一螺纹部，所述输送件的远端设有第二螺纹部，所述第一螺纹部与所述第二螺纹部螺接。
  9. 如权利要求7所述的经导管缩环系统，其特征在于，所述收紧线的近端设有卡槽，所述输送件的远端设有与所述卡槽适配的卡扣。
  10. 如权利要求2所述的经导管缩环系统，其特征在于，所述经导管缩环系统还包括连接于所述输送件近端的引线件，所述引线件的近端具有锥形头部。
  11. 如权利要求1-10任一项所述的经导管缩环系统，其特征在于，所述收紧线的硬度大于或等于所述输送件的硬度。
  12. 如权利要求11所述的经导管缩环系统，其特征在于，所述收紧线采用具有生物相容性的金属材料制成，所述金属材料包括钨、镍钛、钽、金及其合金中的至少一种。
  13. 如权利要求11所述的经导管缩环系统，其特征在于，所述输送件采用具有生物相容性的高分子材料制成，所述高分子材料包括聚乙烯、聚酰胺、聚丙烯、聚氨酯及超高分子量聚乙烯中的至少一种。
  14. 如权利要求1-10任一项所述的经导管缩环系统，其特征在于，所述经导管缩环系统还包括收线器，所述收线器包括壳体和可转动地设置于所述壳体内的绕线轴，所述收线器向所述输送件的远端移动以使所述收紧线的近端活动地穿过所述壳体及所述绕线轴，所述绕线轴相对于所述壳体转动以卷绕所述收紧线，所述绕线轴停止转动时，所述收紧线被锁紧于所述绕线轴与所述壳体之间的径向空间内。
  15. 如权利要求1-10任一项所述的经导管缩环系统，其特征在于，所述经导管缩环系统还包括至少一个间隔件，所述间隔件沿所述输送件输送并穿装至所述收紧线上，所述间隔件位于两个所述锚定组件之间。
  16. 如权利要求1-10任一项所述的经导管缩环系统，其特征在于，所述锚定组件包括锚定件和设于所述锚定件上的穿线结构，所述收紧线的远端连接用于锚入所述心脏组织的第一个所述锚定组件的穿线结构，所述收紧线的近端滑动穿过用于锚入所述心脏组织的其他所述锚定组件的穿线结构。
  17. 如权利要求16所述的经导管缩环系统，其特征在于，所述收紧线穿过用于锚入所述心脏组织的第一个所述锚定组件的穿线结构后使所述收紧线的远端形成第二环圈。
  18. 如权利要求16所述的经导管缩环系统，其特征在于，所述经导管缩环系统还包括输送鞘管和锚定装置，所述锚定装置穿装于所述输送鞘管的内腔中，所述锚定件穿装于所述输送鞘管的远端内腔中，所述锚定组件与所述锚定装置的远端可拆卸连接。
  19. 如权利要求18所述的经导管缩环系统，其特征在于，所述经导管缩环系统还包括止挡部，所述输送鞘管的管壁自远端端部开设有向近端延伸的通槽，所述通槽连通所述输送鞘管的内腔，所述通槽的远端具有开口，所述止挡部设于所述输送鞘管的远端，所述止挡部用于封闭所述开口以将所述锚定件的远端与所述收紧线隔开。
  20. 如权利要求19所述的经导管缩环系统，其特征在于，所述穿线结构整体位于所述输送鞘管的内腔中，所述收紧线穿过所述通槽进入所述输送鞘管的内腔与所述穿线结构连接。
  21. 如权利要求19所述的经导管缩环系统，其特征在于，所述穿线结构至少部分自所述通槽露出而位于所述输送鞘管的外部，所述收紧线与所述穿线结构位于所述输送鞘管外部的部分连接。
  22. 如权利要求19所述的经导管缩环系统，其特征在于，所述止挡部活动设于所述输送鞘管的远端，所述止挡部的近端沿所述输送鞘管的轴向延伸，所述止挡部的远端适配所述输送鞘管的周向且在不受外力作用时封闭所述开口。
  23. 如权利要求18所述的经导管缩环系统，其特征在于，所述锚定装置包括驱动管及穿装在所述驱动管中的连接杆，所述锚定件的近端设有第一连接部，所述驱动管的远端设有与所述第一连接部可拆卸连接的第二连接部，所述连接杆轴向穿设于配合连接的所述第一连接部及所述第二连接部中使所述锚定组件与所述锚定装置保持连接，所述驱动管用于驱动所述锚定组件锚入所述心脏组织。
  24. 如权利要求1所述的经导管缩环系统，其特征在于，所述心脏组织包括二尖瓣瓣环、三尖瓣瓣环、左心室壁、右心室壁。
  25. 权利要求1-24任一项所述的经导管缩环系统的应用，其特征在于，所述经导管缩环系统用于在瓣环成形术中收缩瓣环，或在心室减容术中减小心室容积。
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Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114392010B (zh) * 2021-09-03 2024-04-30 杭州德晋医疗科技有限公司 经导管缩环系统及其应用
CN115737203A (zh) * 2021-09-03 2023-03-07 杭州德晋医疗科技有限公司 防绕线的锚定组件、植入物及经导管心脏修复系统
CN114392011A (zh) * 2021-09-03 2022-04-26 杭州德晋医疗科技有限公司 防绕线的输送装置、经导管缩环系统及其应用
CN114533348B (zh) * 2022-04-27 2022-08-26 杭州德晋医疗科技有限公司 收线系统
WO2023235620A1 (en) * 2022-06-04 2023-12-07 The Board Of Trustees Of The Leland Stanford Junior University Adjustable aortic annuloplasty rings for symmetric annulus reduction and methods for use
CN116531148B (zh) * 2023-07-05 2023-10-20 科瑞迈吉(北京)医疗科技有限公司 一种用于瓣膜修复手术的锁线系统

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030233142A1 (en) * 2002-06-13 2003-12-18 Guided Delivery Systems, Inc. Devices and methods for heart valve repair
CN104055604A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种带锚定装置的心脏瓣膜植入器械
CN106573129A (zh) * 2014-06-19 2017-04-19 4科技有限公司 心脏组织束紧
CN111374799A (zh) * 2018-12-29 2020-07-07 杭州德晋医疗科技有限公司 一种单窗导引的瓣膜缩环系统
CN111655200A (zh) * 2018-01-24 2020-09-11 瓦尔泰克卡迪欧有限公司 瓣环成形术结构的收缩
US20210145584A1 (en) * 2019-10-29 2021-05-20 Valtech Cardio, Ltd. Annuloplasty and tissue anchor technologies
CN113040978A (zh) * 2019-12-27 2021-06-29 杭州德晋医疗科技有限公司 经导管锚钉植入装置及经导管锚钉植入系统
CN113116430A (zh) * 2019-12-31 2021-07-16 杭州德晋医疗科技有限公司 防止缠绕的锚钉及锚钉输送器
CN114392011A (zh) * 2021-09-03 2022-04-26 杭州德晋医疗科技有限公司 防绕线的输送装置、经导管缩环系统及其应用
CN114392010A (zh) * 2021-09-03 2022-04-26 杭州德晋医疗科技有限公司 经导管缩环系统及其应用

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2004308508B2 (en) * 2003-12-23 2011-03-10 Sadra Medical, Inc. Repositionable heart valve

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030233142A1 (en) * 2002-06-13 2003-12-18 Guided Delivery Systems, Inc. Devices and methods for heart valve repair
CN106573129A (zh) * 2014-06-19 2017-04-19 4科技有限公司 心脏组织束紧
CN104055604A (zh) * 2014-07-07 2014-09-24 宁波健世生物科技有限公司 一种带锚定装置的心脏瓣膜植入器械
CN111655200A (zh) * 2018-01-24 2020-09-11 瓦尔泰克卡迪欧有限公司 瓣环成形术结构的收缩
CN111374799A (zh) * 2018-12-29 2020-07-07 杭州德晋医疗科技有限公司 一种单窗导引的瓣膜缩环系统
US20210145584A1 (en) * 2019-10-29 2021-05-20 Valtech Cardio, Ltd. Annuloplasty and tissue anchor technologies
CN113040978A (zh) * 2019-12-27 2021-06-29 杭州德晋医疗科技有限公司 经导管锚钉植入装置及经导管锚钉植入系统
CN113116430A (zh) * 2019-12-31 2021-07-16 杭州德晋医疗科技有限公司 防止缠绕的锚钉及锚钉输送器
CN114392011A (zh) * 2021-09-03 2022-04-26 杭州德晋医疗科技有限公司 防绕线的输送装置、经导管缩环系统及其应用
CN114392010A (zh) * 2021-09-03 2022-04-26 杭州德晋医疗科技有限公司 经导管缩环系统及其应用

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