WO2023029725A1 - Dispositif de transport anti-enchevêtrement, et système de contraction d'anneau transcathéter et son application - Google Patents

Dispositif de transport anti-enchevêtrement, et système de contraction d'anneau transcathéter et son application Download PDF

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Publication number
WO2023029725A1
WO2023029725A1 PCT/CN2022/103488 CN2022103488W WO2023029725A1 WO 2023029725 A1 WO2023029725 A1 WO 2023029725A1 CN 2022103488 W CN2022103488 W CN 2022103488W WO 2023029725 A1 WO2023029725 A1 WO 2023029725A1
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WO
WIPO (PCT)
Prior art keywords
distal end
anchoring
wire
delivery sheath
delivery
Prior art date
Application number
PCT/CN2022/103488
Other languages
English (en)
Chinese (zh)
Inventor
张庭超
郭荣辉
匡经旭
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2023029725A1 publication Critical patent/WO2023029725A1/fr

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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
    • A61F2/2442—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
    • A61F2/2445—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
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a wire-winding-proof delivery device, a transcatheter shrinking ring system including the wire-winding-proof delivery device, and applications thereof.
  • 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 anchors slidably connected to a rope are sequentially implanted in the annulus of the mitral valve through a transcatheter approach, and then the ropes are tightened to shorten the distance between the anchors on the annulus. Tighten the annulus circumferentially, reducing mitral regurgitation.
  • the distal end of the anchor is usually helical or has a sharp point, allowing the anchor to implant into the annulus tissue.
  • the present application aims to provide an anti-winding delivery device, a transcatheter ring shrinkage system and its application, so as to solve the problem of wire winding during anchor implantation, affecting the implantation of the anchor and resulting in surgical failure.
  • the present application proposes an anti-winding conveying device for conveying anchor components and tightening threads.
  • the delivery device includes a delivery sheath and a stop.
  • the tube wall of the delivery sheath is provided with a channel extending from the distal end to the proximal end, the channel communicates with the inner cavity of the delivery sheath, and the distal end of the channel has an opening.
  • the anchor assembly is movably worn on the delivery sheath and connected to the tightening wire.
  • the stopper is provided at the distal end of the delivery sheath, and the stopper is used to close the opening to separate the distal end of the anchor assembly from the tightening wire.
  • the present application provides a transcatheter ring shrinkage system, including an implant, an anchoring device, and the above-mentioned anti-winding delivery device.
  • the implant includes the tightening wire and a plurality of the anchoring components, the anchoring components are detachably connected to the distal end of the anchoring device and worn on the delivery sheath, the delivery The sheath tube is used to deliver the anchor assembly and the tightening wire to the heart tissue, and the anchor device is used to drive the anchor assembly to anchor into the heart tissue.
  • the distal end of the tightening wire is connected to the first anchor assembly for anchoring into the cardiac tissue, and the proximal end of the tightening wire is slidable through all other anchoring components for anchoring into the cardiac tissue.
  • the present application also provides an application of the above-mentioned transcatheter ring shrinkage system, which is used to shrink the valve ring tissue in annuloplasty, or to reduce the volume of the ventricle in ventricular volume reduction. Be careful with chamber volume.
  • a through groove extending from the distal end to the proximal end is opened in the wall of the delivery sheath, and the distal end of the delivery sheath is provided with a At the stop portion of the opening of the closed channel, when the anchor assembly is worn on the delivery sheath and connected to the tightening wire, the anchor assembly is at least partially accommodated in the lumen of the delivery sheath, and the distal end of the anchor assembly Separated from the tightening wire by a stopper so that the portion of the tightening wire that extends distally from where it connects to the anchor assembly is located outside the delivery sheath, thereby preventing the tightening wire from being positioned between the anchor assembly and the delivery sheath Part of the sheath lumen is entangled, avoiding the risk of winding, and facilitating the smooth implantation of the anchoring component.
  • 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 perspective view of the structure of the anchor assembly installed on the distal end of the delivery sheath according to an embodiment of the present application.
  • FIG. 5 is an enlarged schematic view of a V portion in FIG. 4 .
  • Fig. 6 is a schematic three-dimensional structure diagram of an anchor assembly installed on the distal end of a delivery sheath according to another embodiment of the present application.
  • Fig. 7 is an enlarged schematic view of part VII in Fig. 6 .
  • Fig. 8 is a schematic structural diagram of an anchor assembly provided by an embodiment of the present application.
  • Fig. 9 is a perspective exploded structural diagram of the anchor assembly in Fig. 8 .
  • Fig. 10 is a schematic perspective view of an anchor assembly provided in another embodiment of the present application.
  • Fig. 11 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. 12 is a three-dimensional exploded structural diagram of a delivery sheath, an anchor assembly and a tightening wire provided by an embodiment of the present application.
  • Fig. 13 is a three-dimensional structural schematic diagram of the distal end of the retaining wire (that is, the stopper part) threaded into the threading groove of the sleeve.
  • Fig. 14 is a schematic perspective view of the anchor assembly partially inserted into the casing.
  • Fig. 15 is a schematic perspective view of the anchor assembly installed on the distal end of the delivery sheath according to another embodiment of the present application.
  • FIG. 16 is a schematic diagram of the retaining wire (that is, the stop portion) in FIG. 15 retreating to the proximal end to the opening of the unclosed channel at its distal end.
  • Fig. 17 is a schematic perspective view of the anchor assembly installed on the distal end of the delivery sheath according to yet another embodiment of the present application.
  • Fig. 18 is a schematic diagram of the connection between the anchoring assembly and the anchoring device according to an embodiment of the present application.
  • Fig. 19 is a schematic diagram of separation of the anchoring assembly and the anchoring device in Fig. 18 .
  • Fig. 20 is an axial cross-sectional view of the anchor assembly in Fig. 18 when it is connected to the anchor device.
  • Fig. 21 is an axial cross-sectional view of an anchoring device provided in an embodiment of the present application installed in a delivery device.
  • Fig. 22 is a schematic diagram of the pusher pushing the spacer.
  • FIG. 23 is a schematic illustration of a delivery sheath advancing a septum.
  • Fig. 24 is a three-dimensional structural schematic view of the tightening wire passing through the wire take-up device.
  • Fig. 25 is a schematic perspective view of the wire retractor in Fig. 24 with the proximal part of the housing removed.
  • Fig. 26 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. 27 is an axial sectional view of the detachable connection between the wire take-up device and the distal end of the adjustment device.
  • 28 to 32 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 (perpendicular to the axis and perpendicular to the section radius)
  • 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 includes 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 implant 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 sheath 51 .
  • the anchoring assembly 34 is detachably connected to the distal end of the anchoring device 10 and is worn through the delivery sheath 51, the anchoring device 10 is worn in the lumen of the delivery sheath 51, and the delivery sheath 51 is used for the anchoring assembly 34 and the tightening wire 32 are delivered to the annulus.
  • the anchoring device 10 is used to drive the anchor assembly 34 into the annulus.
  • the distal portion 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 delivery sheath 51 can be driven by adjusting the bending angle of the distal end of the guiding device 70.
  • the distal end is curved.
  • Each anchoring component 34 includes an anchoring piece 340 for anchoring into the valve annulus and a threading structure disposed on the anchoring piece 340 , and the anchoring piece 340 is passed through the inner lumen of the distal end of the delivery sheath 51 .
  • the distal end of the tightening wire 32 is connected to the threading structure of the first anchoring component 34 anchored into the valve annulus, and the proximal end of the tightening wire 32 slides through the threading structure of the other anchoring components 34 anchored into the valve annulus.
  • 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.
  • 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 moves axially to the distal end in the lumen of the second guiding sheath 72 of the guiding device 70 until the delivery sheath 51 abuts against the valve annulus, and then the anchoring device 10 is placed in the delivery sheath.
  • 51 inner drive anchor assembly 34 is anchored into the valve 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 tube 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 inner cavity of the delivery sheath 51.
  • the distal end of the groove 512 has an opening.
  • the delivery device 50 also includes a stopper 55 disposed at the distal end of the delivery sheath 51, the stopper 55 is used to close the distal opening of the channel 512 to separate the distal end of the anchor assembly 34 from the tightening wire 32 .
  • the through groove 512 extending from the distal end to the proximal end is opened in the tube wall of the delivery sheath 51, and the distal end of the delivery sheath 51 is provided with a At the stopper portion 55 that closes the opening at the distal end of the channel 512, when the anchor assembly 34 is worn on the delivery sheath 51 and connected to the tightening wire 32, at least part of the anchor assembly 34 (such as the anchor 340) is accommodated in the In the lumen of the delivery sheath 51, and the distal end of the anchoring assembly 34 is separated from the tightening wire 52 by a stopper 55, so that the tightening wire 32 can be connected to the distal end from the place where it is connected to the anchoring assembly 34
  • the extended part is located outside the delivery sheath 51, thereby preventing the tightening wire 32 from being entangled with the part of the anchor assembly 34 located in the inner cavity of the delivery sheath 51 (that is, the
  • the proximal end of the through groove 512 may be closed, or extend along the axial direction of the delivery sheath 51 to penetrate the proximal end of the delivery sheath 51 .
  • the proximal end of the through groove 512 is closed, and the through groove 512 does not pass through opposite ends of the delivery sheath 51 , so that the delivery sheath 51 has high structural strength.
  • 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 and the threading structure are located outside the delivery sheath 51 part of the connection. In this way, the radial dimension of the delivery sheath 51 can be reduced. It can be understood that the threading structure of the anchor assembly 34 is at least partly exposed from the through groove 512, that is, the threading structure is partly located in the lumen of the delivery sheath 51, and partly located outside the delivery sheath 51; or the whole threading structure is located in the delivery sheath 51 of the exterior.
  • the threading structure is at least partially exposed from the through groove 512 , and the tightening wire 32 can be connected to the part of the threading structure outside the delivery sheath 51 , the connection operation is simple, and the tightening line 32 is located outside the delivery sheath 51 as a whole.
  • the portion of the tightening wire 32 that extends proximally from where it connects with the threading structure can also be located in the lumen of the delivery sheath 51 .
  • the threading structure of the anchoring assembly 34 may be entirely located in the lumen of the delivery sheath 51, that is, the anchoring assembly 34 is entirely located in the inner lumen of the delivery sheath 51, and the tightening wire 32 passes through the channel 512 Enter the lumen of the delivery sheath 51 and connect to the threading structure of the anchor assembly 34 .
  • the part where the tightening wire 32 is connected to the anchor assembly 34 is located in the lumen of the delivery sheath 51 , and the rest of the tightening wire 32 can be located outside the delivery sheath 51 .
  • the anchoring member 340 includes an anchoring portion 341 and an anchoring seat 343 connected to a proximal end of the anchoring portion 341 .
  • the anchoring seat 343 is used for detachable connection with the distal end of the anchoring device 10
  • the anchoring portion 341 is used for anchoring into the annulus of heart tissue 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 anchor into heart tissue such as the annulus, and the anchoring component 34 is not easy to fall off after implantation.
  • the anchoring portion 341 may have another suitable configuration that enables the anchoring portion 341 to engage and substantially fixate to tissue, such as but not limited to barbs, hooks, tines, etc., And in order to facilitate transportation, at least part of the barbs and hooks are made of materials with shape memory function.
  • the threading structure of the anchoring component 34 includes a connecting piece 345 movably sleeved on the anchor seat 343 and a threading ring 347 movably connected with the connecting piece 345 , and the tightening wire 32 is connected to the threading ring 347 .
  • the threading ring 347 is 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.
  • Tight wire 32 is integrally located on the outside of delivery sheath 51 .
  • the threading ring 347 is at least partially exposed from the through groove 512 , which means that the threading structure enters the through groove 512 when the anchor assembly 34 is worn on the delivery sheath 51 so that the threading ring 347 is at least partially exposed from the through groove 512 .
  • part of the threading ring 347 is exposed from the through groove 512 , that is, part of the threading ring 347 is located outside the delivery sheath 51 .
  • the threading ring 347 is entirely exposed from the through groove 512 , that is, the threading ring 347 is entirely located outside the delivery sheath 51 .
  • the connecting piece 345 can also 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 component is designed on the anchoring portion 341 so that the connecting piece 345 does not Just drop from the anchor piece 340 .
  • 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 tightening wire 32 is connected to the anchor assembly 34 by connecting the threading ring 347 .
  • the distal end of the tightening wire 32 is connected to the first anchoring assembly 34 for anchoring into the valve annulus, and the proximal end of the tightening wire 32 can slide through the threads of other anchoring assemblies 34 for anchoring into the valve annulus.
  • Ring 347 Specifically, the tightening wire 32 is folded in half after passing through the threading ring 347 of the first anchoring assembly 34 used for anchoring into the valve annulus, and the distal end of the tightening wire 32 is fixed through the crimping tube 33, and the crimping tube 33 cannot be threaded through. Ring 347.
  • the pressing tube 33 can be made of a metal material with good biocompatibility (such as but not limited to stainless steel) and pressed through a press, so as to fix the distal end of the tightening wire 32 .
  • the pressure 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 pressure tube 33 .
  • 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 at least partially pass through the through groove 512.
  • the tightening wire 32 Exposed and located outside the delivery sheath 51 , the tightening wire 32 is connected to the part of the threading ring 347 outside the delivery sheath 51 , and the tightening line 32 can be located outside the delivery sheath 51 as a whole after being connected to the threading ring 347 .
  • 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, and the threading ring 347 is located outside the delivery sheath tube 51 as a whole, and the threading space is smaller. Larger, more conducive to the tightening line 32 to pass through the threading ring 347, and the connection operation is easier. 5 and 7, the axial length of the slot 512 is greater than the axial distance H between the proximal end of the connecting piece 345 and the distal end of the anchoring part 341 (see FIG.
  • the opening at the distal end of the through groove 512 is provided with a chamfer or a rounded corner, so that the opening at the distal end of the through groove 512 is flared. It can be understood that, during the process of wearing the anchor assembly 34 on the distal end of the delivery sheath 51, when the threading ring 347 is partly located in the lumen of the delivery sheath 51 and partly located outside the delivery sheath 51, the distal end The flaring shape of the opening is more conducive for the threading ring 347 to enter the through groove 512 , thereby facilitating the assembly of the anchor assembly 34 .
  • the anchoring seat 343 includes a seat body 3433, a first connecting portion 3431 and an inserting portion 3437 respectively connected to the proximal end and the distal end of the seat body 3433, and a fixing Connected to the support block 3435 of the socket part 3437 .
  • the distal surface of the seat body 3433 abuts against the proximal surface of the support portion, the proximal surface of the support block 3435 abuts against the distal surface of the support portion, and the outer diameters of the seat body 3431 and the support block 3435 are approximately equal and larger than that of the support portion. Therefore, the seat body 3431, the supporting part and the supporting block 3435 are roughly in the shape of an "I" shape, and form an annular connecting groove.
  • the connecting piece 345 is sheathed on the anchor seat 343 , the connecting piece 345 is at least partially received in the connecting groove.
  • the first connecting part 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 defines an insertion hole extending along 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.
  • 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.
  • anchoring portion 341 can also be directly fixedly connected to the distal end surface of the support block 3435 by means of welding, etc., and the support block 3435 is directly fixedly connected to the proximal end surface of the support portion at the proximal end of the seat body 3433, so that there is no need to set an insertion portion 3437.
  • 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 connecting piece 345 is movably sleeved on the supporting portion of the anchor base 343 through the assembly hole 3452 .
  • the connecting hole 3454 is used for movably connecting the threading ring 347 , and the threading ring 347 passes through the connecting hole 3454 of the connecting piece 345 , so as to buckle with the connecting piece 345 to realize the flexible connection between the threading ring 347 and the connecting piece 345 .
  • connection hole 3454 extends along the radial direction of the anchor member 340 .
  • the connecting hole 3454 extends along the axial direction of the anchor 340 .
  • 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 greater than the diameter of the support portion of the anchor seat 343 and smaller than the maximum outer diameter of the anchor seat 343 (that is, the outer diameter of the seat body 3433 and the support block 3435), so that the connecting piece 345 can be movably sleeved on the anchor On the anchor seat 343 and will not fall off from the anchor seat 343.
  • the threading ring 347 can be a ring or an ellipse, and the shape of its axial section can also be a circle or an ellipse.
  • 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 member 345 are both circular holes.
  • the connecting member 345 can rotate 360 degrees around the central axis Z of the anchoring member 340 (see FIGS. . Further, the axial width of the connecting groove of the anchor seat 343 can be greater than the axial thickness of the fitting part 3451, preferably 2-3 times the axial thickness of the fitting part 3451, so that the connecting part 345 can be along the length of the anchoring part 340. Axial movement, that is, the connecting member 345 also has a translational degree of freedom to move along the central axis Z of the anchoring member 340 .
  • the connecting member 345 has two degrees of freedom, including 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 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 fastened to the connecting member 345 can tighten the thread 32
  • the tightening force moves to the state after the tightening line 32 is tightened, and the threading ring 347 is movably connected with the connector 345, and the threading direction of the threading ring 347 can be along the circumferential direction of the annulus, so that the threading ring 347 is movably connected to the ring.
  • the resistance of the tightening line 32 during the contraction process is greatly reduced, and the tightening line 32 does not have a bending situation, and the contraction is stable and smooth. Furthermore, the connecting piece 345 can move along the axial direction of the anchoring piece 340. When the anchoring depths of the anchoring parts 341 of multiple anchoring components 34 are inconsistent, 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 applied force is also greatly reduced, which reduces the force of the anchoring component 34 on the annulus, reduces the risk of damage to the annulus, and avoids the situation that the tightening force of a single anchoring component 34 accounts for a large proportion.
  • the risk of the anchor component 34 falling off is reduced, and the implantation is safer.
  • a clamping end 3455 protrudes from the side of the connector 345 away from the anchor seat 343, and the radial width of the clamping end 3455 is the same as the radial width of the through groove 512.
  • the locking end 3455 is locked in the through groove 512 . In this way, it is possible to prevent the connecting member 345 from rotating to drive the threading ring 347 to rotate during the delivery of the anchor assembly 34 , ensuring stable and smooth delivery of the anchor assembly 34 .
  • the connecting hole 3454 is opened at the clamping end 3455 , and the connecting hole 3454 extends along the radial direction of the anchoring member 340 .
  • a guiding slope 3456 protrudes toward the proximal end of the locking end 3455 along the axial direction of the anchor member 340 .
  • 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 stopper 55 is movably arranged at the distal end of the delivery sheath 51 , and the stopper 55 opens the distal opening of the channel 512 to allow the delivery sheath 51 to be movably worn.
  • the anchor assembly 34 when the anchor assembly 34 is delivered, the stopper portion 55 closes the distal opening of the channel 512 .
  • the stopper 55 is movably provided at the distal end of the delivery sheath 51, and is especially suitable for the case where the threading structure of the anchor assembly 34 (especially the threading ring 347) is at least partially exposed from the through groove 512 and is located outside the delivery sheath 51, By controlling the stopper 55 to open the distal opening of the through groove 512 , the threading structure of the anchor assembly 34 can slide into the through groove 512 from the opening, so that the delivery sheath 51 with a smaller radial dimension can be selected.
  • the proximal end of the stopper 55 extends along the axial direction of the delivery sheath 51, and the distal end of the stopper is adapted to the circumferential direction of the delivery sheath 51 and closes the distal opening of the channel 512 when no external force is applied.
  • the stopper 55 is an elongated piece, and at least the distal part of the stopper 55 is made of a material with a shape memory function (such as but not limited to nickel-titanium, nickel-titanium alloy, etc.).
  • the distal end of the blocking portion 55 is made of material with shape memory function, or the entire stop portion 55 is made of material with shape memory function.
  • the distal end of the stopper 55 is a non-closed loop in a natural state, so that the guideline of the stopper 55 is good and easy to retract, and the movement stroke of the stopper 55 can be increased to ensure that the stopper 55
  • the distal end of the stopper 512 can pass through the groove 512 to form a blocking effect, and the distal opening of the through groove 512 is closed firmly and stably, and can ensure that the stopper 55 has sufficient strength and is not easy to break.
  • the distal end of the stopper portion 55 may also be a circumferential arc segment adapted to the delivery sheath 51 in a natural state. It should be noted that the natural state means that the stop portion 55 is not subjected to any external force.
  • the stopper 55 can be a stop wire movably penetrated in the tube wall or the lumen of the delivery sheath 51, and the stop wire can be nickel-titanium A wire whose distal end is heat-set to form an open loop. It can be understood that the distal end of the retaining wire closes the distal opening of the through groove 512 when it is not subjected to external force, and the threading structure of the anchor assembly 34 cannot slide out from the distal opening of the through groove 512 due to the stop of the retaining wire.
  • the radial cross-sectional shape of the retaining wire can be circular, oblate, rectangular, square or other shapes, etc., which is not specifically limited in the present application.
  • the stopper 55 can be fixed on the distal end of the delivery sheath 51 to close the opening at the distal end of the channel 512 .
  • the stopper 55 can be a stopper fixed to the opening of the distal end of the through groove 512 by bonding, welding, etc., and the stopper extends along the radial direction of the delivery sheath 51 To cross the through groove 512, so that the blocking piece closes the distal opening of the through groove 512.
  • the structure of the delivery device 50 provided by the present application will be further described by taking the anchor assembly 34 threaded on the delivery sheath 51, the threading ring 347 is located outside the delivery sheath 51 as a whole, and the stopper 55 is a stop wire as an example. .
  • the delivery device 50 further includes a sleeve 57 fixedly nested in the inner lumen of the distal end of the delivery sheath 51.
  • the sleeve 57 includes a tube body 571 and The annular portion 574 is disposed at the distal end of the tube body 571 .
  • the annular portion 574 has an annular passage 5741, the proximal end of the retaining wire (that is, the stop portion 55) is movably extending axially in the tube wall or lumen of the delivery sheath 51, and the distal end of the retaining wire is movably worn on the In the annular channel 5741.
  • the tubular body 571 is provided with a slot 572 corresponding to the through groove 512 , and the annular portion 574 There is a notch corresponding to the slot 572 .
  • the size of the notch of the annular portion 574 is preferably consistent with the radial width of the slot 572 .
  • the distal end of the retaining wire is inserted into the annular channel 5741 and penetrates the gap of the annular portion 574, so that the gap of the annular portion 574 is closed, that is, the through groove 512 and the narrow gap are closed.
  • the distal opening of slot 572 is closed.
  • the axial length of the tubular body 571 is greater than or equal to the axial length of the anchor assembly 34, and the radial width of the slot 572 is greater than or equal to the radial width of the through groove 512, so that the anchor member 340 of the anchor assembly 34 can completely accommodate
  • the clamping end 3455 of the connector 345 of the anchoring component 34 passes through the notch of the annular portion 574 and the slot 572 of the tube body 571 and is clamped in the through groove 512, so that the threading ring 347 passes through the slot. 572 and the through groove 512 are exposed and are located outside the delivery sheath 51 as a whole.
  • the anchor 340 is threaded in the distal lumen of the delivery sheath 51 by being threaded through the sleeve 57 nested in the distal lumen of the delivery sheath 51 .
  • the shape of the annular channel 5471 is adapted to the non-closed ring at the distal end of the blocking wire, so that the blocking wire can move smoothly without being blocked when opening or closing the distal opening of the channel 512 .
  • the tube body 571 can be made of metal material (such as but not limited to stainless steel) and inserted into the distal lumen of the delivery sheath 51, and fixed by welding, gluing or hot melting.
  • several welding holes are opened on the tube wall of the tube body 571, and the tube body 571 is preferably fixedly connected in the delivery sheath 51 by thermal fusion. The welding holes opened on the tube body 571 make the tube body 571 The fusion with the delivery sheath tube 51 is more efficient and the connection effect is better.
  • the annular portion 574 includes an annular seat 5742 disposed at the distal end of the tube body 571 and an annular seat cover 5744 mated with the annular seat 5742 , the annular seat 5742 and the annular An annular channel 5741 is formed between the seat covers 5744 .
  • the annular seat cover 5744 has a gap corresponding to the slot 572 , so that the annular portion 574 has a gap corresponding to the slot 572 .
  • the notch size of the annular portion 574 is smaller than 1/3 of the length of the annular channel 5741, that is to say, the notch size of the annular portion 574 is smaller than 1/3 of the length of the non-closed loop at the distal end of the retaining wire. Preferably it is 1/6.
  • the size of the notch of the annular portion 574 is reasonably set to ensure that the retaining wire can close the notch of the annular portion 574, thereby closing the distal openings of the through groove 512 and the slot 572, and making the distal reset of the retaining wire easier and more stable.
  • the wall or lumen of the delivery sheath 51 is provided with a stop channel (not shown in the figure) along the axial direction
  • the tube body 571 is provided with a channel connecting the stop channel and the annular channel 5741
  • the threading groove 5711, the proximal end of the retaining wire moves through the threading groove 5711 and extends along the axial direction of the blocking channel, and then extends to the outside of the patient's body.
  • the distal end of the threading groove 5711 is arc-shaped and communicates with the annular channel 5471, and the proximal end of the threading groove 5711 communicates with the stop channel.
  • the distal end of the wire threading groove 5711 is set in an arc shape, so that the retaining wire can move smoothly between the wire threading groove 5711 and the annular channel 5471 .
  • the sleeve 57 also includes a cover plate 577, which is an arc-shaped sheet structure as a whole, and is fixedly connected with the tube body 571 by means of welding or the like. The cover plate 577 is used to limit the movement of the retaining wire in the wire threading groove 5711, thereby enhancing the retractability of the retaining wire.
  • the distal end of the delivery sheath 51 is also provided with a butt joint 59 .
  • the butt joint 59 is cylindrical as a whole, and its distal end can be connected with the proximal end of the tube body 571 by spot welding, and its proximal end and the delivery sheath tube 51 can be melted and connected with polyether block polyamide, thereby strengthening the connection between the tube body 571 and the delivery sheath.
  • the connection strength of the pipe 51 is also provided with a butt joint 59 .
  • the butt joint 59 is cylindrical as a whole, and its distal end can be connected with the proximal end of the tube body 571 by spot welding, and its proximal end and the delivery sheath tube 51 can be melted and connected with polyether block polyamide, thereby strengthening the connection between the tube body 571 and the delivery sheath.
  • the connection strength of the pipe 51 is also provided with a butt joint 59 .
  • the proximal end of the retaining wire moves through the threading groove 5711 and extends proximally in the stop channel of the delivery sheath 51, and the retaining wire maintains a straight state in the stop channel and extends to the outside of the patient's body. Pulling or releasing the retaining wire opens or closes the gap of the annular portion 574 , thereby opening or closing the distal openings of the through groove 512 and the slot 572 .
  • the anchoring assembly 34 can be pushed through the anchoring device 10 worn in the delivery sheath 51 to be released from the distal end of the delivery sheath 51, and the anchoring assembly 34 can be driven in through the anchoring device 10.
  • the wall or lumen of the delivery sheath 51 is axially provided with a stopper channel, and the distal end of the stopper channel runs through the wall of the delivery sheath 51 and is located in the channel.
  • the retaining wire (that is, the stop part 55) is movably worn in the stop channel, and the far end of the retaining wire protrudes from the far end of the stop channel, and the far end of the retaining wire forms a ring to close the far end of the through groove 512 opening (as shown in Figure 15).
  • the delivery device 50 may not be provided with a sleeve 57 , which simplifies the structure of the delivery device 50 .
  • the outer peripheral wall of the distal end of the delivery sheath 51 can be sleeved with an annular sheath 58, and the annular sheath 58 has a gap corresponding to the through groove 512, and the outer peripheral wall of the distal end of the delivery sheath 51 is in contact with the annular sheath 58.
  • An annular slot is formed between the casings 58 , the far end of the stop channel communicates with the annular slot, and the far end of the retaining wire is movably fitted in the annular slot.
  • the retaining wire can be limited to move in the annular slot, which can ensure that the retaining wire closes the opening of the through groove 512, and can also enhance the retractability of the retaining wire.
  • the movable distance of the retaining wire needs to be greater than the radial width of the through groove 512, so that the distal opening of the through groove 512 can be fully opened, so as not to hinder the anchoring assembly.
  • the threading structure of 34 slides out from through groove 512.
  • the diameter of the wire should not be too small.
  • the diameter of the wire is 0.2 mm to 0.8 mm.
  • the number of the retaining wire can also be one, and it only needs to ensure that the length of the retaining wire passing through the annular channel 5741 can close the distal openings of the through groove 512 and the slot 572 .
  • 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.
  • first connecting part 3431 and the second connecting part 122 are docked, the respective S-shaped buckles of the anchor seat 343 and the driving tube 12 are snapped together, and the inner cavities of the two are communicated, and are mounted on the driving tube 12.
  • the distal end of the inner connecting rod 14 protrudes from the distal end of the driving tube 12 and is inserted into the lumen of the first connecting part 3431 and the second connecting part 122, thereby limiting the separation of the first connecting part 3431 and the second connecting part 122 , so that the anchoring assembly 34 is kept connected with the driving tube 12, and the anchoring assembly 34 can be driven to rotate by rotating the driving tube 12, so that the anchoring part 341 is anchored into the valve annulus.
  • 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 delivery device 50 further includes an elastic filling tube 54 for filling the gap extending axially between the delivery sheath 51 and the anchoring device 10 .
  • the elastic filling tube 54 is used to fill the axially extending gap between the delivery sheath 51 and the driving tube 12 of the anchoring device 10, so that the driving tube 12 will not be excessively deformed when transmitting torque and thrust, and avoid driving
  • the stroke loss at the proximal end of the tube 12, and the excellent elastic properties of the elastic filling tube 54 can also provide a certain degree of bending back straightness at the distal end of the delivery sheath 51.
  • the elastic filling tube 54 may be a spring tube.
  • the implant 30 further includes at least one spacer 36, the spacer 36 is worn on the tightening wire 32, and the spacer 36 is located between two adjacent anchors. Between components 34. It can be understood that the spacer 36 can prevent the excessive tightening of the tightening wire 32 from causing the distance between two adjacent anchoring components 34 to be too short and damage the valve annulus. The tightening force received by the anchoring component 34 ensures that the anchoring component 34 is implanted stably.
  • the spacer 36 is a cylindrical member with a certain length, preferably made of a biocompatible material. The spacer 36 can be wrapped with a membrane to reduce the risk of heart tissue such as valve annulus being damaged by the spacer 36 .
  • a spacer 36 may be provided between any two adjacent anchor assemblies 34 of the plurality of anchor assemblies 34 of the implant 30, or two or more anchor assemblies at intervals may be arranged.
  • the component 34 is provided with a spacer 36 , 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 tightening wire 32 to move through.
  • the tightening wire 32 passes through the guide hole 92 of the pusher 90, and the pusher 90 pushes the spacer 36 along the tightening wire 32 into the second guide of the guide device 70.
  • the delivery sheath 51 is threaded in the second introducer sheath 72 to advance the septum 36 in the second introducer sheath 72 .
  • the delivery sheath 51 and the anchoring device 10 are withdrawn, and the spacer 36 is worn at the proximal end of the tightening wire 32 and the tightening wire 32
  • the pushing member 90 pushes the spacer 36 into the second guiding sheath 72 of the guiding device 70 along the tightening wire 32 along the pushing direction b.
  • the pusher 90 is taken out, and the second anchor assembly 34 worn on the delivery sheath 51 is threaded on the tightening wire 32 through the threading ring 347 exposed outside the delivery sheath 51, and the delivery sheath 51 further Worn in the second guiding sheath 72 , the spacer 36 is located on the distal side of the delivery sheath 51 .
  • the delivery sheath 51 moves axially and distally in the second guiding sheath 72, and the spacer 36 can be pushed to the valve annulus, and then the anchoring device 10 pushes the second anchoring assembly 34 out.
  • the sheath 51 is delivered and the second anchor assembly 34 is anchored into the annulus such that the spacer 36 is positioned between the two anchor assemblies 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 delivery device 50 further includes a delivery member 53, the distal end of the tightening wire 32 is connected to the first anchoring assembly 34 for anchoring into the annulus, and the delivery member The distal end of 53 is connected to the proximal end of tightening wire 32, and the proximal end of delivery element 53 extends outside the body.
  • the anchoring assembly 34, the spacer 36, etc. can be worn on the tightening wire 32 through the delivery of the delivery member 53, so that the tightening wire 32 can choose an appropriate implant length, so that it is not necessary to adjust the tightening wire 32 in the body. Cutting is performed to avoid the falling off of particles on the wire, and the shrinking ring operation is safer.
  • the distal end of the tightening wire 32 is connected to the first anchoring assembly 34 for anchoring into the valve annulus, and the other anchoring assemblies 34 for anchoring into the valve annulus are delivered along the delivery member 53 and worn to the Tighten on line 32.
  • the spacer 36 is also conveyed along the conveyor 53 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 proximal end of the tightening wire 32 is folded in half to form a U shape, and the delivery member 53 passes through the double fold of the tightening wire 32 to realize a detachable connection.
  • the conveying member 53 may also be detachably connected to the tightening wire 32 through threaded connection, snap connection, etc., which will not be described in detail.
  • the conveying member 53 can also be non-detachably connected with the tightening wire 32, and the conveying member 53 can be withdrawn from the body by cutting the conveying member 53 outside the body.
  • the catheter retractor 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 device 38 is transported along the conveying member 53 and is worn on the tightening wire 32.
  • the wire take-up device 38 is used to adjust the tightening wire 32 to adjust the distance between a plurality of anchor assemblies 34, and after adjusting a plurality of anchor components.
  • the spacing between the components 34 locks the tightening wire 32 behind.
  • a wire take-up 38 is used to tighten the take-up wire 32 to reduce the spacing between the plurality of anchor assemblies 34 .
  • 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 casing 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.
  • Via 3832 When the wire take-up device 38 is worn on the conveying member 53, the conveying member 53 first passes through a wire hole 3816 into the installation space 3816 of the housing 381, then passes through the through hole 3832 of the bobbin 383, and then passes through another wire hole 3816. Hole 3818 extends out of housing 381 .
  • 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 column 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 limiting post 385, and the proximal part of the limiting 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 delivery member 53 can be omitted, and the length of the tightening wire 32 is long enough to extend outside the body of the patient.
  • the tightening wire 32 can be tightened to achieve After shrinking the ring to achieve the best effect of alleviating reflux, the tightening thread 32 can be locked and cut through the locking nails of the prior art.
  • 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 shrinkage system 1 The application process and work of the transcatheter ring shrinkage system 1 according to the embodiment of the present application will be described below with reference to Fig. 2, Fig. 3 and Fig. 28 to 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 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 threading ring 347 of the first anchoring assembly 34 is exposed from the through groove 512 as a whole, tightened
  • the 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 uses 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 piece 53; Pass through the threading ring 347 of the second anchoring assembly 34 (the second anchoring assembly 34 has been connected to the distal end of the anchoring device 10 and passed through the delivery sheath 51) and push the delivery sheath in the guide device 70 Tube 51, the first spacer 36 and the second anchor assembly 34 are delivered along the delivery member 53 by the forward push of the delivery sheath 51 to be worn on the tightening wire 32 and delivered to the vicinity of the annulus, the spacer 36 is interposed between the first anchor assembly 34 and the second anchor assembly 34 .
  • 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 device 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 device 38, and the wire take-up device 38 is sent to the tightening wire 32 along the conveying member 53; Then, the rotating tube 84 of the adjusting device 80 is rotated forward, so that the winding shaft 383 of the wire take-up device 38 adjusts the length of the tightening wire 32 on the valve annulus to reduce the distance between multiple anchoring components 34, thereby driving the valve ring to 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 tricuspid annuloplasty, and details 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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  • Health & Medical Sciences (AREA)
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  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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Abstract

L'invention concerne un dispositif de transport anti-enchevêtrement (50), et un système de contraction d'anneau transcathéter (1) et son application. Le dispositif de transport (50) est conçu pour transporter un ensemble d'ancrage (34) et un fil d'enroulement (32). Le dispositif de transport (50) comprend une gaine de transport (51) et une partie d'arrêt (55). Une paroi de tube de la gaine de transport (51) est pourvue d'une rainure traversante (512) s'étendant vers une extrémité proximale à partir d'une partie d'extrémité distale, la rainure traversante (512) étant en communication avec une cavité interne de la gaine de transport (51), et une extrémité distale de la rainure traversante (512) ayant une ouverture. L'ensemble d'ancrage (34) est monté mobile dans la gaine de transport (51) de manière pénétrante, et est relié au fil d'enroulement (32). La partie d'arrêt (55) est disposée au niveau de l'extrémité distale de la gaine de transport (51), et la partie d'arrêt (55) est conçue pour sceller l'ouverture afin de séparer une extrémité distale de l'ensemble d'ancrage (34) vis-à-vis du fil d'enroulement (32). Dans le dispositif de transport (50), la rainure traversante (512) et la partie d'arrêt (55) sont disposées au niveau de l'extrémité distale de la gaine de transport (51), de sorte que la partie du fil d'enroulement (32) s'étendant à partir d'une articulation entre le fil d'enroulement (32) et l'ensemble d'ancrage (34) vers l'extrémité distale est située à l'extérieur de la gaine de transport (51), et par conséquent, cela empêche le fil d'enroulement (32) de s'enchevêtrer avec la partie de l'ensemble d'ancrage (34) située à l'intérieur de la gaine de transport (51), ce qui permet de réduire le risque d'enchevêtrement et de faciliter l'implantation en douceur de l'ensemble d'ancrage (34).
PCT/CN2022/103488 2021-09-03 2022-07-01 Dispositif de transport anti-enchevêtrement, et système de contraction d'anneau transcathéter et son application WO2023029725A1 (fr)

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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
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
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
CN116269941B (zh) * 2023-05-11 2023-08-08 科瑞迈吉(北京)医疗科技有限公司 环缩力单点可调的瓣膜缩环手术系统

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