WO2023088392A1 - 一种分体式可精准锚定的介入环中瓣系统 - Google Patents

一种分体式可精准锚定的介入环中瓣系统 Download PDF

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Publication number
WO2023088392A1
WO2023088392A1 PCT/CN2022/132662 CN2022132662W WO2023088392A1 WO 2023088392 A1 WO2023088392 A1 WO 2023088392A1 CN 2022132662 W CN2022132662 W CN 2022132662W WO 2023088392 A1 WO2023088392 A1 WO 2023088392A1
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WIPO (PCT)
Prior art keywords
valve
ring
anchoring
interventional
stent
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PCT/CN2022/132662
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English (en)
French (fr)
Inventor
金磊
魏来
吴康健
吴嘉
范志豪
李丽艳
Original Assignee
北京佰仁医疗科技股份有限公司
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Application filed by 北京佰仁医疗科技股份有限公司 filed Critical 北京佰仁医疗科技股份有限公司
Priority to EP22894922.8A priority Critical patent/EP4434495A1/en
Priority to AU2022392687A priority patent/AU2022392687A1/en
Priority to CA3238585A priority patent/CA3238585A1/en
Publication of WO2023088392A1 publication Critical patent/WO2023088392A1/zh

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    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0052—T-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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • the invention relates to an artificial biological heart valve, in particular to a split-type interventional ring-in-valve system that can be precisely anchored.
  • the present invention intends to set a stable and regular circular support structure in the previously implanted mitral valve annulus or tricuspid annulus, so as to provide stable and precise interventional anchoring for the ball-expanded valve in the annulus.
  • the valve-in-the-intervention ring system of the present invention is composed of two parts: a valve-in-the-intervention ring anchoring bracket and a valve-in-the-intervention artificial biological ring.
  • a custom-made one corresponding to the shape, structure and size of the valve annulus can be automatically adapted to the valve annulus through positioning and release, and can be combined and clamped with the supra and subvalvular tissues ; and then through the catheter, the valve in the artificial biological ring is transported to the anchoring valve frame, and the ball is expanded and released, so that the valve in the ring and the anchoring bracket are assembled and combined in the body.
  • the center of the previously implanted annulus is coaxial to achieve precise anchoring of the valve in the intervening annulus to obtain a treatment effect similar to or better than that of ViV.
  • a split-type interventional ring-in-valve system that can be precisely anchored, the system includes a split interventional ring-in-valve anchoring bracket and an interventional artificial biological ring-in-valve.
  • the shape and structure of the valve-in-annular anchoring stent matched the three-dimensionally reconstructed annulus and the real structures above and below the valve in patients who had previously implanted an annuloplasty ring and suffered postoperative valve failure.
  • valve-in-annular anchoring stent is first delivered to the patient's failed valve annulus to be released, deformed, and engaged with the supravalvular and subvalvular tissues of the failed valve annulus;
  • the valve-in-annular anchoring stent is released, and the valve support of the intervening bioartificial annulus is deformed and expanded to the functional state of the intervening annulus, so that the annulus anchoring stent is deformed again and placed in the expanded intervening annulus.
  • the re-deformation of the valve anchoring stent in the intervening ring causes the anchoring stent to rejoin and anchor with the subvalvular structure.
  • the recombined anchoring is a preset anchoring for realizing precise and regular circles.
  • the valve-in-annulus system also includes a delivery assembly, the delivery assembly includes an interventional ring-in-valve anchoring stent delivery set and an interventional ring-in-valve delivery set, and the interventional ring-in-valve anchoring stent delivery set includes a delivery catheter, an interventional ring Mid-lobe anchor stent loader.
  • the previously implanted annuloplasty rings are all kinds of mitral annuloplasty rings implanted for various causes of mitral regurgitation, or various types of tricuspid annuloplasty rings implanted for various causes of tricuspid regurgitation ring; the shape and structure of the valve anchoring stent in the intervention ring are accurately matched with the type of the valve ring implanted before and the real shape and anatomical structure of the three-dimensional reconstruction of personalized image data of postoperative valve failure; The intervening valve anchoring stent and the intervening bioartificial annulus are introduced separately, and then reassembled into one in vivo.
  • the re-deformation of the intervening valve anchoring stent and the diseased mitral The valve or tricuspid valve and the subvalvular tissue complete the regular circular preset anchoring, realize the valve anchoring in the interventional artificial biological ring from the stress of the previously implanted valve ring shape, and obtain the long-lasting stability of the regular circular anchoring.
  • the valve in the intervening ring is the mitral valve in the ring, the tricuspid valve in the ring or the aortic valve in the ring.
  • the valve-in-the-intervention anchoring stent has a compressed state placed in the catheter, a first anchoring state after being released through the catheter, and a second anchoring state after being combined with the valve in the interventional ring, the first anchoring state
  • the valve-in-annulus anchoring stent is deformed after being released by the catheter to engage with the tissues above and below the valve annulus of the failed valve; in the second anchoring state, the valve-in-annular anchoring
  • the stent undergoes secondary deformation through the expansion of the intervening valve in the ring, and combines with the intervening valve in the ring to complete the final anchoring combination with the subvalvular tissue of the patient's failed valve ring.
  • the valve in the interventional artificial biological ring is transported by the catheter to the valve in the interventional ring in the first state.
  • the secondary deformation is combined with the expanded intervening artificial bio-annular valve to realize the pre-regular circular pre-planning between the anchoring bracket and the patient's mitral or tricuspid valve leaflet or subvalvular tissue. set anchor.
  • the valve anchoring stent in the interventional ring is processed and shaped into a large atrial surface according to the anatomical structure after three-dimensional reconstruction based on the type, shape and size of the previously implanted valve ring and personalized image data.
  • valve anchoring stent Small conical funnel shape on the ventricle surface, the deformation and back shape of the valve anchoring stent in the interventional ring are adapted to the supravalvular and subvalvular tissue characteristics of the failed mitral or tricuspid valve after being released through the catheter Aligned joints and buttresses to reshape the regular circular preset structure; in the second anchoring state, in the interventional ring in the first anchoring state, the valve anchoring stent is delivered and introduced through the catheter The valve in the artificial biological ring is inserted and released by the ball expansion, and it is integrated with the anchoring bracket of the valve in the interventional ring, so that the anchoring bracket of the valve in the interventional ring is expanded from the original conical funnel shape to a cylinder together with the valve in the interventional ring Shaped, the centripetal clamping produced by the secondary deformation, tightly combined with the intervening valve in the ring, and at the same time complete the tight pre-set anchoring with the patient's mitral valve or
  • the real structure of the three-dimensional reconstruction is a digital image model or a 3D printed simulation entity model
  • the real structure of the three-dimensional reconstruction is a three-dimensional image of virtual simulation after digital conversion of comprehensive images of CT, ultrasound and nuclear magnetic field and corresponding 3D printing Simulation solid model.
  • the anchoring bracket of the valve in the ring is an umbrella tube-shaped bracket structure, including the atrium surface, the ventricle surface and the anchoring bracket connection between the two.
  • the umbrella shape that matches the real shape of the three-dimensional reconstruction is the first grid part; the ventricular surface is a plurality of positioning hook loops that match the real shape of the three-dimensional reconstruction of the patient's diseased annulus subvalvular image data; the anchor
  • the connecting part of the fixed bracket is funnel-shaped with a round mouth and has a second grid part.
  • the first anchoring state of the connecting part of the valve-in-annular anchoring stent is the first anchoring state after being delivered and released through the catheter, which is the shape-setting memory state outside the body of the stent. Taper, the taper is 5-45 degrees; the connecting part of the anchoring bracket is deformed and expanded from the first anchoring state to the cylindrical second anchoring state.
  • the positioning hook loops are two and the two leaflets of the patient's mitral valve (the mitral valve ring), or three are precisely matched with the junction of the three leaflets of the tricuspid valve (the tricuspid valve ring).
  • the positioning hook loop is released through the catheter prior to the atrial surface of the ring-in-valve anchoring stent, and inserted into the matching position of the junction of the patient's ring-in-valve anchoring stent, Realize that the atrial surface of the positioning anchoring stent matches the shape of the patient's atrium; in the second anchoring state after the valve anchoring stent in the intervention ring is deformed, the periphery of the connecting part of the positioning hook loop and the anchoring stent is filled in the valve Between the inner annulus and the junction of the intervening valve in the annulus.
  • the positioning hook loop is filled in the eccentric area of the previously implanted valve annulus, so that the central axis of the connecting part of the valve anchoring stent in the ring is coaxial with the center of the previously implanted valve annulus.
  • the ventricular surface of the valve-in-annular anchoring stent has several anchoring hook loops, which extend from the connecting part to the ventricular surface and then turn over to match the real subvalvular tissue shape of the three-dimensional reconstruction of the patient's failed subannulus image data.
  • the anchoring hook loop In the first anchoring state of the valve-in-the-ring anchoring stent, after the anchoring hook loop is released through the catheter, it is aligned with the tissue under the annulus of the failed valve in the patient, and in the second anchoring state of the valve-in-the-ring anchoring stent Next, the plurality of anchoring hook loops form a clamping part through deformation and the joint force of the atrial surface and the connecting part of the valve-in-annular anchoring stent. The valve leaflets and subvalvular tissue are intertwined and tightly combined.
  • the number of said anchoring hook loops is 2-9, preferably 4-6.
  • the end of the atrial surface of the connecting part of the valve in the ring anchoring bracket is provided with a plurality of fixed struts or bent brackets for embedding the valve in the ring support, and the fixed struts or brackets are bent along the direction of the atrial plane Extending axially, its ends are bent toward the axis of the anchoring stent.
  • the connecting part of the valve-in-the-ring anchoring bracket is provided with several ends for embedding the outflow end of the valve-in-ringing bracket to be bent centripetally, and these centripetal bendings are connected with the atrium surface end of the connecting part of the valve-in-ring anchoring bracket
  • a plurality of fixed struts or bent upper and lower encircles are arranged on the inner part for embedding the atrial end of the middle valve stent in the intervention ring to form an integrated body with the anchor bracket to ensure zero displacement of the middle valve in the intervention ring.
  • the first mesh portion and the second mesh portion of the valve-in-the-ring anchoring stent are formed by unit meshes composed of compressible diamond meshes, V-shaped meshes, and/or hexagonal or polygonal meshes, so The first mesh part is adaptively connected to the second mesh part.
  • the outer periphery of the grid part of the atrium surface is 1-2 mm away from the patient's atrium wall, preferably 1.5 mm apart.
  • the diameter of the inner peripheral edge of the second grid portion matches the outer diameters of various sizes and specifications of the petals in the interventional artificial biological ring.
  • the surface of the ring-in-valve anchoring stent is covered with a layer of medical polymer film.
  • connection between the atrial surface, the ventricular surface and the anchoring stent of the valve-in-the-ring anchoring stent is a three-dimensional formed structure or a split connection structure after laser integral cutting.
  • the anchoring bracket is made of metal material or non-metallic material with shape memory and recoverable performance, and the anchoring bracket is made of nickel-titanium alloy.
  • the valve in the interventional artificial biological ring includes a radially compressible cobalt-chromium alloy stent that can be expanded by a balloon to form a cylindrical shape, or a radially compressible self-expandable nickel-titanium alloy stent that is cylindrically shaped.
  • the valve frame is cobalt-based alloy cobalt or chromium alloy or nickel-titanium alloy.
  • the intervening valve-in-annular anchoring stent delivery device and the intervening bio-annular valve-in-annulus delivery device can be approached via the inferior vena cava via the femoral vein, or via the superior vena cava via the jugular vein or the subclavian vein. Intravenous delivery to the tricuspid valve position; for the mitral annulus, transapical or left atrium or transseptal approach through the femoral vein to the mitral valve position.
  • Fig. 1 is a physical view of different types of mitral and tricuspid annuloplasty rings implanted in the prior art.
  • Fig. 2 is a physical diagram of various forming rings in the prior art.
  • 3A-B are schematic diagrams of implanting a valve-in-ring system into a plastic ring according to an embodiment of the present invention.
  • Fig. 4 is a schematic diagram of the implantation of the valve-in-the-ring system according to an embodiment of the present invention.
  • Fig. 5 is a schematic diagram of the implantation of the valve-in-the-ring system according to an embodiment of the present invention.
  • Fig. 6 is a schematic diagram of an interventional ring-in-valve system according to an embodiment of the present invention.
  • Fig. 7 is a schematic diagram of a valve anchoring stent in an interventional ring according to an embodiment of the present invention.
  • FIGS. 8-10 are schematic diagrams of valve anchoring stents in interventional rings with various shapes according to embodiments of the present invention.
  • 11A-B are schematic diagrams of fixing struts and centripetal bending of an anchoring stent according to an embodiment of the present invention.
  • 12A-C are schematic diagrams of the first anchoring state of the valve anchoring stent in the interventional ring according to an embodiment of the present invention.
  • FIGS. 13A-C are schematic diagrams of the second anchoring state of the valve anchoring stent in the interventional ring according to an embodiment of the present invention.
  • Fig. 14 is a schematic diagram of secondary anchoring of the anchoring hook loop and chordae after the interventional mitral valve anchoring stent is implanted into a human body according to an embodiment of the present invention.
  • Fig. 15 is a schematic diagram of a valve in an interventional artificial biological ring according to an embodiment of the present invention.
  • Figure 16 is a schematic diagram of a delivery system according to an embodiment of the present invention.
  • 17A-E are schematic diagrams of the process of anchoring a stent to a valve in an interventional ring through a transapical approach according to an embodiment of the present invention.
  • Figure 18A-C is a schematic diagram of the process of delivering the anchoring stent through the transapical approach to the middle valve of the ring according to an embodiment of the present invention.
  • 19A-D are schematic diagrams of the process of anchoring a stent in the intervening intervening ring through the femoral vein via the femoral vein according to an embodiment of the present invention.
  • Figure 20A-C is a schematic diagram of the process of delivering the anchoring stent into the middle valve of the transatrial septal interventional ring through the femoral vein according to an embodiment of the present invention.
  • 21A-C are schematic diagrams of the process of inserting a valve anchoring stent into an interventional ring via a composite approach according to an embodiment of the present invention.
  • 22A-D are schematic diagrams of the process of delivering an anchoring stent through a compound approach to the valve in the interventional ring according to an embodiment of the present invention.
  • Fig. 23A-F is a schematic diagram of the interventional ring-in-valve system of this application according to the embodiment of the present invention for tricuspid valve intervention.
  • 24A-B are schematic diagrams of positioning hook loops of the anchoring stent filling the eccentric region of the previously implanted annulus according to an embodiment of the present invention.
  • a split-type interventional ring-in-valve system that can be accurately anchored according to the present invention includes a separate interventional ring-in-valve anchoring bracket 10 and an interventional artificial biological ring-in-valve 20.
  • the shape and structure of the valve anchoring stent in the interventional ring match the three-dimensionally reconstructed valve ring and the real structures above and below the valve after implantation of the annuloplasty ring30 in patients with postoperative valve failure.
  • valve anchoring stent in the interventional ring is first delivered to the patient’s failed valve annulus for release, deformation, and engagement with the supravalvular and subvalvular tissue of the failed valve annulus; the valve in the interventional artificial biological ring is delivered to the The anchoring bracket of the valve in the intervening ring is released, and the valve bracket of the intervening bioartificial ring is deformed and expanded to the functional state of the intervening valve in the ring, so that the anchoring bracket of the valve in the ring is deformed and expanded again.
  • the valve-in-annulus unites, and at the same time, the re-deformation of the valve-in-the-annulus anchoring stent causes the anchoring stent to rejoin and anchor with the subvalvular structure.
  • the intervening valve-in-the-valve anchoring stent is one of the key components of the intervening ring-in-the-valve system of the present invention.
  • Anchor bracket connection part 13 the atrium surface is umbrella-shaped, and has an umbrella-shaped shape that matches the real shape of the three-dimensional reconstruction of the patient's atrial surface image data, which is the first grid part;
  • the ventricular surface is a positioning hook Annulus 121, two leaflets with the patient's mitral valve (mitral valve ring), or three and three leaflets of the tricuspid valve (tricuspid valve ring) for precise alignment and matching;
  • the stent connection part is funnel-shaped with a round mouth and has a second grid part.
  • the first anchoring state of the connecting part of the valve-in-annular anchoring stent is the first anchoring state after being delivered and released through the catheter, which is the shape-setting memory state outside the body of the stent.
  • Taper the taper is 5-45 degrees; the connecting part of the anchoring bracket is deformed and expanded from the first anchoring state to the cylindrical second anchoring state.
  • the positioning hook loop is released through the catheter prior to the atrial surface of the ring-in-valve anchoring stent, and inserted into the matching position of the junction of the patient's ring-in-valve anchoring stent, Realize that the atrial surface of the positioning anchoring stent matches the shape of the patient's atrium; in the second anchoring state after the valve anchoring stent in the intervention ring is deformed, the periphery of the connecting part of the positioning hook loop and the anchoring stent is filled in the valve Between the inner annulus and the junction of the intervening valve in the annulus.
  • the positioning hook loop is filled in the eccentric area of the previously implanted valve annulus, so that the central axis of the connecting part of the valve anchoring stent in the ring is coaxial with the center of the previously implanted valve annulus.
  • the ventricular surface of the valve-in-annular anchoring stent has several anchoring hook loops 122, which extend from the connecting part to the ventricular surface and then turn over to match the real subvalvular tissue shape of the three-dimensional reconstruction of the patient's failed subannulus image data. .
  • the anchoring hook loop In the first anchoring state of the valve-in-the-ring anchoring stent, after the anchoring hook loop is released through the catheter, it is aligned with the tissue under the annulus of the failed valve in the patient, and in the second anchoring state of the valve-in-the-ring anchoring stent Next, the plurality of anchoring hook loops form a clamping part through deformation and the joint force of the atrial surface and the connecting part of the valve-in-annular anchoring stent. The valve leaflets and subvalvular tissue are intertwined and tightly combined.
  • the shape of the atrial surface of the valve anchoring stent in the intervention ring and the size of the coverage area and the shape, quantity, length, angle and structural relationship of the stent ventricular surface and the anchoring hook loop 122 are all based on the preoperative CT and ultrasound images of the individual patient.
  • valve anchoring stent After three-dimensional reconstruction (3mensio), the real structure of the patient's atrium (above the valve) and ventricle (below the valve), and the real size of each radius measured by the image are accurately matched with the structure, so as to make the interventional ring
  • the processing drawing of the valve anchoring stent is finally customized into a personalized ring-in-valve anchoring stent through laser cutting and three-dimensional forming processing of a specific nickel-titanium memory alloy tube.
  • the valve-in-the-annulus anchoring stent processed and manufactured according to the real image data of the patient is the state before the stent is crimped, and it is also the first anchoring state after the stent is delivered into the annulus through the catheter and released.
  • the second anchoring state of the valve-in-the-ring anchoring stent is when the valve-in-ring anchoring stent is delivered into the anchoring stent through the catheter, and the valve is expanded by balloon-assisted expansion so that the valve-in-ring anchoring stent is anchored by the first anchoring state.
  • the state is transformed into the second anchoring state, and the deformation force of the stent is combined with the ball expansion force released by the valve in the intervention ring to form a whole, and at the same time, several anchoring hook loops are inserted into the ventricular surface of the subvalvular anchoring stent 122.
  • the self-adaptive alignment is combined with the chordal space and the subvalvular tissue.
  • the fixed strut at the atrial end of the connecting structure deforms into the second anchoring state, and the fixed strut 111 is encircled centripetally and is axially parallel, so that the end of the fixed strut Together with the bent back hook 112 at the ventricular end of the connecting part, it buckles the struts at both ends of the valve support in the intervention ring.
  • the stent is precisely integrated into one body to ensure zero displacement of the valve in the interventional ring.
  • the split-type interventional ring-in-valve system that can be accurately anchored in the present invention, the interventional artificial biological ring-in-valve, because of the combination of anchoring brackets, the valve frame structure of the valve only serves for the reasonable support of the three leaflets, It includes a cobalt-chromium alloy stent that is radially compressible and can be expanded into a cylindrical shape by a balloon, or a nickel-titanium alloy stent that is radially compressible and self-expandable and becomes a cylindrical shape, and three fan-shaped valves are arranged inside the stent Each leaflet has a free edge, an arc-shaped bottom edge, and leaflet junction connecting parts extending on both sides, and the support is a metal mesh tube or various forms of crimpable valve holders that can support the junction of the three leaflets.
  • the valve frame is cobalt-based alloy cobalt or chromium alloy or nickel-titanium alloy.
  • a split-type interventional ring-in-valve system that can be accurately anchored in the present invention also includes a delivery assembly, the delivery assembly includes an interventional ring-in-valve anchoring stent delivery kit and an interventional artificial biological ring-in-valve delivery kit.
  • the valve anchoring stent delivery kit includes a delivery catheter, a valve anchoring stent loader in the interventional ring.
  • the delivery kit of the valve in the artificial biological ring includes a delivery device for the valve in the artificial biological ring, a guide sheath, a valve crimping device and a pressure pump.
  • valve-in-the-intervention anchoring stent delivery device and the valve-in-the-intervention artificial ring delivery device can be implemented for patients with mitral valve failure after mitral annuloplasty via the femoral vein through the interatrial septum, apical puncture or left atrial puncture.
  • the treatment of ViR; ViR can also be used for patients with tricuspid valve failure after tricuspid annuloplasty via the inferior vena cava via the femoral vein or via the superior vena cava via the jugular or subclavian vein.
  • the content of the present invention is summarized as follows: 1 Separate anchoring stent design and intervening valve in the interventional ring are intervened separately, and then assembled and combined in the heart; 2 The three-dimensional real shape reconstructed based on the preoperative personalized annulus and the image data of supravalvular and subvalvular structures and structure, personalized design and manufacture of anchoring stents with a specific shape and structure; 3Using the junction of the valve leaflets, through the specially designed positioning hooks, accurately locate the atrial surface of the anchoring stent and fill the inner edge of the irregular valve ring, artificially construct A regular circular anchoring support structure; 4The flap in the interventional ring is introduced into the anchoring stent and released in the first anchoring state, and the anchoring stent is deformed into the second anchoring state with the help of the ball expansion force released by the flap in the intervening ring.
  • the valve can be integrated with the second anchoring state of the anchoring stent in the valve annulus, and at the same time, the subvalvular tissue can be fastened again to complete the final stable and regular circular anchoring; 5After the anchoring stent is released, the In the first state, the deformation automatically adapts to insertion with cardiac diastole, personalized anatomical alignment, stalemate and clamping; in the second state, the intervention is realized through the deformation process of fitting the valve in the intervention ring with the help of ball expansion surgery The release control of the valve in the ring achieves automatic precision and zero displacement.
  • the transapical approach is mostly familiar to cardiac surgeons.
  • the loaded anchoring stent is delivered to the failed mitral annulus of the patient via the apical approach, and the positioning hook is released to complete the positioning; the atrial surface, the stent connection structure and the ventricular surface of the anchoring stent are sequentially released to make the ventricular surface
  • the anchoring hooks and loops are aligned and combined; the anchoring stent transporter is withdrawn, and the middle valve of the interventional ring loaded in advance is delivered to the anchoring stent along the original route, and then the middle valve of the interventional ring is assisted by a balloon to make the anchoring
  • the stent is deformed into the second anchoring state, realizing precise integration with the valve in the interventional ring, and fastening with the subvalvular tissue at the same time to complete the final anchoring.
  • the transseptal approach through the femoral vein is a method familiar to cardiologists.
  • Put the loaded anchoring stent through the femoral vein enter the right atrium through the inferior vena cava, pass through the interatrial septum into the patient's failed mitral annulus, release the positioning hook loop to complete the positioning), and release the anchoring stent sequentially on the ventricular surface , the stent connection structure and the atrium surface, so that the ventricular surface anchoring hook loops are aligned and combined, which is the first anchoring state of the anchoring stent; withdraw the anchoring stent transporter, and place the loaded interventional ring along the original route.
  • the compound approach method is suitable for cases where the cardiac structure is complex according to preoperative image analysis, and the anchoring alignment and firmness of the designed interventional anchoring stent are uncertain in the first state.
  • the loaded anchoring stent is delivered to the failed mitral valve annulus via the apical approach, the positioning hook is released for positioning, the atrial surface and connecting part of the anchoring stent are released sequentially, and then the ventricular surface of the anchoring stent is released for use.
  • the alignment of the anchoring hook and loop is combined, which is the first state of the anchoring stent, and the anchoring stent transporter is not withdrawn to pull the anchoring stent; then, at the same time, through the venous route where the guide wire has been placed in advance, through the interatrial septum
  • the loaded middle valve of the interventional ring is transported into the anchoring stent, and the middle valve of the interventional ring is assisted by balloon expansion, so that the anchoring stent is deformed into the second anchoring state, realizing self-precise integration with the middle valve of the interventional ring.
  • the subvalvular tissue forms a clamping and fastening combination to complete the final anchoring; withdraw the valve transporter in the interventional ring, confirm that the second anchoring state of the anchoring stent is the designed state and the anchoring stent is firmly anchored, and then withdraw the anchoring stent transporter.
  • valve-in-the-ring system at the tricuspid valve position the most common approach is through the femoral vein from the inferior vena cava to the right atrium to reach the tricuspid valve position, and its embodiment is the same as the mitral valve position 2 Transfemoral vein from the right atrium The atrium passes through the interatrial septum, and the same path is taken from the femoral vein to the right atrium, see Figure 23.
  • the interventional ring-in-valve system of the present invention has been confirmed to be feasible by carrying out the above-mentioned technical solution in animal experiments.
  • the significance of the present invention lies in: 1Split design, the anchoring of the valve is handed over to the precisely designed anchoring bracket, so that the valve bracket of the valve in the intervention ring is only responsible for the symmetrical support of the three valve leaflets, which is the most suitable for artificial biological intervention.
  • the valve meets the symmetry of the valve leaflets and the synchrony of opening and closing, and the durable and stable structural guarantee; 2
  • the anchoring bracket and the valve in the intervention ring are implanted anteriorly and posteriorly respectively, and are tightly combined again in the valve ring to ensure zero displacement of the valve.
  • the anchoring bracket is designed according to the real anatomical shape and structure of the 3D reconstruction of preoperative image data, which realizes positioning, release, and valve support.
  • the upper and subvalvular tissues are automatically combined and clipped, reshaping the regular circular preset structure, and making the anchoring of the intervening valve more precise;
  • 4The split design is expected to improve and solve the problem caused by the type of annuloplasty ring implanted before.
  • the treatment process of the valve in the precise interventional ring the analysis of relevant data, the shape design, processing and manufacturing of the interventional aortic valve anchoring stent, the relevant data obtained during the whole process of interventional treatment, and postoperative follow-up data, etc., are used as independent data units Accumulate a large amount of personalized image data, anchoring stent design and manufacturing parameters, interventional treatment process and postoperative results and other related data, gradually realize the split type can accurately anchor the interventional ring valve system, and implement intelligent interventional treatment and scale.

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Abstract

一种分体式可精准锚定的介入环中瓣系统，包括分体的介入环中瓣锚定支架（10）和介入人工生物环中瓣（20），介入环中瓣锚定支架（10）的形态和结构与此前植入过瓣膜成形环（30）发生术后瓣膜失功的患者影像数据经三维重建后的瓣环及瓣上和瓣下的真实结构相匹配，介入环中瓣锚定支架（10）首先被输送至患者失功瓣环内释放、形变、与失功瓣环的瓣上和瓣下组织对位接合；介入人工生物环中瓣（20）被输送至介入环中瓣锚定支架（10）内释放，介入人工生物环中瓣（20）的瓣膜支架形变扩启至介入环中瓣的功能状态，使介入环中瓣锚定支架（10）再次形变与扩启的介入环中瓣结合，同时介入环中瓣锚定支架（10）的再次形变致介入环中瓣锚定支架（10）与瓣下结构再次结合而锚定。

Description

一种分体式可精准锚定的介入环中瓣系统 技术领域
本发明涉及一种人工生物心脏瓣膜，特别涉及一种分体式可精准锚定的介入环中瓣系统。
背景技术
根据我国瓣膜性心脏病加权患病率3.8％的估计，我国约有2500万瓣膜病患者(BMC Cardiovasc Disord.2021,21:339)，因大部分必须要救治的国内患者年龄均在65岁或以下，所以通过瓣膜外科行人工瓣膜置换和瓣膜成形手术修复，应该在未来相当长的时期内作为主要治疗手段。前者需要植入人工心脏瓣膜，后者则需要植入瓣膜成形环来完成瓣膜修复。据估计，2021年三尖瓣成形术用三尖瓣成形环约26000枚，二尖瓣成形术用二尖瓣成形环约14000余枚，累计用环数量已经显著超过人工生物瓣的数量，并且每年还在以两位数增长。进一步看，由于国内瓣膜成形术普及推广的时间和手术经验的积累有限，特别是瓣膜退行性变的比例较欧美国家偏低，致使这些植入瓣膜成形环行瓣膜成形术修复的术后患者，不可避免在进入高龄时面临瓣膜的再次失功，故不得不需要介入环中瓣(ViR)治疗。
据为数可观的文献报道，因之前植入的瓣膜成形环材质、结构和形态的不同(图1)，与介入瓣中瓣(ViV)相比，无论是ViR的术后并发症，还是术后中期环中瓣的功能以及生活质量都远不如ViV的治疗效果好。研究者们认为，ViR的这些问题主要源于此前植入瓣膜成形环的材质、形态和结构的不规则导致ViR植入后变形和不可避免的更多瓣周漏。为此，本发明提供了一种分体式的介入环中瓣系统的设计。
发明内容
本发明意在此前植入的二尖瓣环或三尖瓣环内先设置一个稳定、规则圆形的支撑结构，以此重设为球扩的环中瓣提供稳定精准的介入锚定。本发明的介入环中瓣系统是由一个介入环中瓣锚定支架和一个介入人工生物环中瓣两部分共同构成，发明的核心要点是依据术前个性化影像数据经三维重建后的瓣环及瓣上和瓣下的真实解剖结构，定制加工一个与瓣环形态、结构、尺寸相对应，通过定位释放可自动适应性于瓣环内、与瓣上和瓣下组织进行性结合和夹持；随后再经导管把介入人工生物环中瓣输送至该锚定瓣架内球扩释放，以致使介入的环中瓣与锚定支架实现体内组装结合，通过锚定支架连接部的中轴与先前植入瓣环的中心同轴，实现介入环中瓣的精准锚定，以获得类似或优于ViV的治疗效果。
本发明所采取的具体的技术方案为：一种分体式可精准锚定的介入环中瓣系统，该系统包括分体的介入环中瓣锚定支架和介入人工生物环中瓣，所述介入环中瓣锚定支架的形态和结构与此前植入过瓣膜成形环发生术后瓣膜失功的患者影像数据经三维重建后的瓣环及瓣上和瓣下的真实结构相匹配，所述介入环中瓣锚定支架首先被输送至患者失功瓣环内释放、形变、与失功瓣环的瓣 上和瓣下组织对位接合；所述介入人工生物环中瓣被输送至所述介入环中瓣锚定支架内释放，所述介入人工生物环中瓣的瓣膜支架形变扩启至介入环中瓣的功能状态，使所述环中瓣锚定支架再次形变与扩启的介入环中瓣结合，同时所述介入环中瓣锚定支架的再次形变致锚定支架与瓣下结构再次结合锚定。
进一步，所述再次结合锚定为是实现精准规则圆形的预设锚定。所述环中瓣系统还包括输送组件，所述输送组件包括介入环中瓣锚定支架输送套件和介入环中瓣输送套件，所述介入环中瓣锚定支架输送套件包括输送导管、介入环中瓣锚定支架装载器。所述此前植入过的瓣膜成形环为各类病因二尖瓣关闭不全被植入的各类二尖瓣成形环，或各类病因三尖瓣关闭不全被植入的各类三尖瓣成形环；所述介入环中瓣锚定支架的形态和结构与所之前植入的瓣环的类型和发生术后瓣膜失功的个性化影像数据经三维重建的真实形态和解剖结构精准匹配；所述介入环中瓣锚定支架和介入人工生物环中瓣先后分别路入，然后在体内再组装合二为一，所述介入环中瓣锚定支架的因介入瓣膜释放再次形变与病变二尖瓣或三尖瓣及瓣下组织完成规则圆形的预设锚定，实现介入人工生物环中瓣锚定免于此前植入瓣环形状的应力影响，获得规则圆形锚定的持久稳定。所述介入环中瓣为环中二尖瓣、环中三尖瓣或环中主动脉瓣。所述介入环中瓣锚定支架具有置于导管内的压缩状态、经导管释放后的第一锚定状态和与介入环中瓣结合后的第二锚定状态，所述第一锚定状态下，所述环中瓣锚定支架经所述导管释放后形变与患者失功瓣环瓣上和瓣下的组织对位接合；所述第二锚定状态下，所述环中瓣锚定支架经介入的环中瓣扩启而二次形变，与介入环中瓣结合同时完成与患者失功瓣环的瓣下组织最终锚定结合。所述第二锚定状态下，为所述介入人工生物环中瓣被导管输送至第一状态下的介入环中瓣锚定支架内球扩释放，球扩外力使环中瓣锚定支二次形变，与被扩启的所述介入人工生物环中瓣结合为一体，实现锚定支架与患者二尖瓣位或三尖瓣位的瓣叶或瓣下的组织完成事先规则圆形的预设锚定。所述第一锚定状态下，所述介入环中瓣锚定支架依据此前被植入瓣环的类型、形状和尺寸以及个性化影像数据经三维重建后解剖结构，被加工定形为心房面大、心室面小的圆锥形漏斗状，所述介入环中瓣锚定支架经导管输入并释放后的形变和回形适应患者失功的二尖瓣或三尖瓣的瓣上和瓣下组织个性化对位接合、对持，以重塑规则圆形的预设结构；所述第二锚定状态下，在所述第一锚定状态的介入环中瓣锚定支架内，经导管输送导入介入人工生物环中瓣并被球扩释放，与介入环中瓣锚定支架结合为一体，使介入环中瓣锚定支架由原来的圆锥形漏斗状与介入的环中瓣一起被扩为圆柱状，二次形变产生的向心回形夹持，与介入的环中瓣紧密结合的同时完成与患者二尖瓣位或三尖瓣位及瓣下组织紧密的预设锚定。
进一步，所述三维重建的真实结构为数字影像模型或3D打印的仿真实体模型，所述三维重建的真实结构是CT、超声及核磁的综合影像数字化转换后虚拟仿真的三维图像以及相应的3D打印仿真实体模型。所述环中瓣锚定支架为一伞管形支架结构，包括心房面、心室面和两者之间的锚定支架连接部，所述心房面为伞片状、具有与患者心房面影像数据三维重建的真实形态相匹配的伞片 状，即为第一网格部分；所述心室面为多个与患者病变瓣环瓣下影像数据三维重建真实形态相匹配的定位钩袢；所述锚定支架连接部为圆口漏斗状、具有第二网格部分。所述环中瓣锚定支架连接部第一锚定状态为经导管输送并释放后的第一状态为支架体外的定形记忆状态，所述连接部从心房面到心室面的定形记忆状态具有收缩锥度，所述锥度为5-45度；所述锚定支架的连接部经形变扩张由第一锚定状态变形为圆柱状的第二锚定状态。定位钩袢为两个与患者二尖瓣两瓣叶(二尖瓣环)，或为三个与三尖瓣三个瓣叶(三尖瓣环)交界位置精准对位匹配。所述介入环中瓣锚定支架的第一锚定状态下，所述定位钩袢经导管先于环中瓣锚定支架心房面释放，插入与之匹配的患者环中瓣瓣叶交界位置，实现定位锚定支架心房面与患者心房形态相匹配；所述介入环中瓣锚定支架形变后第二锚定状态下，所述定位钩袢与所述锚定支架的连接部外周充填于瓣环内与介入环中瓣结合部之间。第二锚定状态下，所述定位钩袢充填于先前植入瓣环的偏心区域，使环中瓣锚定支架连接部的中轴与先前植入瓣环的中心同轴。所述环中瓣锚定支架心室面具有数个锚定钩袢，自连接部延伸至心室面后翻折，与患者失功瓣环下影像数据三维重建的真实的瓣下组织形态相匹配。所述环中瓣锚定支架第一锚定状态下，所述锚定钩袢经导管释放后，于患者失功瓣环下组织对位，所述环中瓣锚定支架第二锚定状态下，所述多个锚定钩袢通过形变与环中瓣锚定支架心房面和连接部合力作用形成夹持部，所述多个形变后的锚定钩袢与患者病失功瓣环下的瓣叶及瓣下组织交织而紧密结合。所述锚定钩袢为2-9个，优选为4-6个。所述环中瓣锚定支架的连接部的心房面端部设置有用于嵌入介入环中瓣支架的多个固定支杆或支架弯折，所述固定支杆或支架弯折，沿心房面方向轴向延伸，其端部朝向锚定支架的轴心弯折。所述环中瓣锚定支架的连接部设置有用于嵌入介入环中瓣支架流出端若干端头向心弯折，这些向心弯折与所述环中瓣锚定支架的连接部心房面端部设置用于嵌入介入环中瓣支架心房端的多个固定支杆或弯折上下合围与锚定支架形成嵌合成为一体，确保介入环中瓣释放零移位。所述固定支杆或支架弯折为3-12个，优选为6-9个。所述环中瓣锚定支架第一网格部分和第二网格部分为由可压缩的菱形网格、V形网格和/或六边形或多边形网格构成的单元网格形成，所述第一网格部分与第二网格部分适应性连接。所述心房面的网格部分的外周缘与患者心房壁间隔1-2mm，优选间隔1.5mm。所述第二网格部分的内周缘直径与介入式人工生物环中瓣各种相应大小规格的外径相匹配。所述环中瓣锚定支架表面被覆有一层医用高分子薄膜。所述环中瓣锚定支架的心房面、心室面和锚定支架的连接部为激光一体切割后三维成形结构或分体连接结构。所述锚定支架为具有形状记忆可回形性能的金属材料或非金属材料，所述锚定支架为镍钛合金材质。介入人工生物环中瓣包括径向可压缩，并可被球囊扩张后呈圆柱状的钴铬合金支架，或径向可压缩自膨后呈圆柱状的镍钛合金支架，三个设置于所述支架内侧的扇形瓣叶，三个所述扇形瓣叶均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，所述支架为金属网管。瓣架为钴基合金钴或铬合金或镍钛合金。所述介入环中瓣锚定支架输送器和介入人工生物环中瓣输送器，对于三尖瓣环中瓣可经股静脉由下腔静脉入路，或经颈静脉或锁骨下静脉由上腔静脉输送至三尖瓣位；对于 二尖瓣环中瓣可经心尖或经左心房或经股静脉过房间隔入路至二尖瓣位。
本发明中，每完成一次针对个性化预设实现精准塑形锚定的介入环中瓣治疗过程，所有上述相关数据作为独立的数据单元，累积大量个性化的数据单元，通过大数据的算法以及AI实现所述分体式可精准锚定介入环中瓣系统的智能化、规模化与产业化。
附图说明
图1为现有技术中植入的不同类型的二尖环成形环和三尖瓣成形环瓣实物图。
图2为现有技术中各种成形环实物图。
图3A-B为根据本发明实施例的介入环中瓣系统植入成形环意图。
图4为根据本发明实施例的介入环中瓣系统植入成形示意图。
图5为根据本发明实施例的介入环中瓣系统植入成形示意图。
图6为根据本发明实施例的介入环中瓣系统示意图。
图7为根据本发明实施例的介入环中瓣锚定支架示意图。
图8-10为根据本发明实施例的形态各异的介入环中瓣锚定支架示意图。
图11A-B为根据本发明实施例的锚定支架的固定支杆和向心弯折示意图。
图12A-C为根据本发明实施例的介入环中瓣锚定支架第一锚定状态示意图。
图13A-C为根据本发明实施例的介入环中瓣锚定支架第二锚定状态示意图。
图14为根据本发明实施例的介入二尖瓣锚定支架植入人体后的锚定钩袢与腱索二次锚定示意图。
图15为根据本发明实施例的介入人工生物环中瓣示意图。
图16为根据本发明实施例的输送系统示意图。
图17A-E为根据本发明实施例的经心尖路入介入环中瓣锚定支架过程示意图。
[根据细则26改正，12.01.2023]图18A-C为根据本发明实施例的经心尖路入环中瓣送入锚定支架过程示意图。
图19A-D为根据本发明实施例的经股静脉路入穿房间隔介入环中瓣锚定支架过程示意图。
[根据细则26改正，12.01.2023]图20A-C为据本发明实施例的经股静脉路入穿房间隔介入环中瓣送入锚定支架过程示意图。
图21A-C根据本发明实施例经复合路径路入介入环中瓣锚定支架过程示意图。
图22A-D根据本发明实施例经复合路径路入介入环中瓣送入锚定支架过程示意图。
[根据细则26改正，12.01.2023]图23A-F根据本发明实施例三尖瓣位介入本申请介入环中瓣系统示意图。
图24A-B为根据本发明实施例的锚定支架的定位钩袢充填于先前植入瓣环的偏心区域示意图。
具体实施方式
参阅图3-图6，本发明的一种分体式可精准锚定的介入环中瓣系统，该系统包括分体的介入环中瓣锚定支架10和介入人工生物环中瓣20，所述介入环中瓣锚定支架的形态和结构与此前植入过瓣膜成形环30发生术后瓣膜失功的患者影像数据经三维重建后的瓣环及瓣上和瓣下的真实结构相 匹配，所述介入环中瓣锚定支架首先被输送至患者失功瓣环内释放、形变、与失功瓣环的瓣上和瓣下组织对位接合；所述介入人工生物环中瓣被输送至所述介入环中瓣锚定支架内释放，所述介入人工生物环中瓣的瓣膜支架形变扩启至介入环中瓣的功能状态，使所述环中瓣锚定支架再次形变与扩启的介入环中瓣结合，同时所述介入环中瓣锚定支架的再次形变致锚定支架与瓣下结构再次结合锚定。
参阅图7-图13，介入环中瓣锚定支架是本发明介入环中瓣系统的关键部件之一，为一伞管形支架结构，包括心房面11、心室面12和两者之间的锚定支架连接部13，所述心房面为伞片状、具有与患者心房面影像数据三维重建的真实形态相匹配的伞片状，即为第一网格部分；所述心室面为定位钩袢121，为两个与患者二尖瓣两瓣叶(二尖瓣环)，或为三个与三尖瓣三个瓣叶(三尖瓣环)交界位置精准对位匹配；所述锚定支架连接部为圆口漏斗状、具有第二网格部分。所述环中瓣锚定支架连接部第一锚定状态为经导管输送并释放后的第一状态为支架体外的定形记忆状态，所述连接部从心房面到心室面的定形记忆状态具有收缩锥度，所述锥度为5-45度；所述锚定支架的连接部经形变扩张由第一锚定状态变形为圆柱状的第二锚定状态。所述介入环中瓣锚定支架的第一锚定状态下，所述定位钩袢经导管先于环中瓣锚定支架心房面释放，插入与之匹配的患者环中瓣瓣叶交界位置，实现定位锚定支架心房面与患者心房形态相匹配；所述介入环中瓣锚定支架形变后第二锚定状态下，所述定位钩袢与所述锚定支架的连接部外周充填于瓣环内与介入环中瓣结合部之间。第二锚定状态下，所述定位钩袢充填于先前植入瓣环的偏心区域，使环中瓣锚定支架连接部的中轴与先前植入瓣环的中心同轴。所述环中瓣锚定支架心室面具有数个锚定钩袢122，自连接部延伸至心室面后翻折，与患者失功瓣环下影像数据三维重建的真实的瓣下组织形态相匹配。所述环中瓣锚定支架第一锚定状态下，所述锚定钩袢经导管释放后，于患者失功瓣环下组织对位，所述环中瓣锚定支架第二锚定状态下，所述多个锚定钩袢通过形变与环中瓣锚定支架心房面和连接部合力作用形成夹持部，所述多个形变后的锚定钩袢与患者病失功瓣环下的瓣叶及瓣下组织交织而紧密结合。
介入环中瓣锚定支架心房面的形态以及覆盖面积的大小和支架心室面及锚定钩袢122的形态、数量、长短和角度以及结构关系，都是根据患者个体的术前CT和超声影像数据，经三维重建(3mensio)后患者的心房(瓣上)和心室(瓣下)的真实结构以及图像测量得出的各径限的真实尺寸与结构精准对应匹配，以此制成介入环中瓣锚定支架的加工图纸，通过特定的镍钛记忆合金管材激光切割和三维成形加工，最终定制成个性化的环中瓣锚定支架。
上述按患者影像真实数据加工制造环中瓣锚定支架为支架压握前的状态，也是支架经导管输送至瓣环内释放后的第一锚定状态。介入环中瓣锚定支架的第二锚定状态是当介入环中瓣经导管输送至锚定支架内，通过球囊辅助扩张，瓣膜被扩启使环中瓣锚定支架由第一锚定状态形变为第二锚定状态，凭借支架的形变的回形力与介入环中瓣释放的球扩力相结合成为一体，同时对位插入瓣下锚定支架心室面的数个锚定钩袢122，随着心脏的舒缩过程自动适应性对位结合于腱索间隙及瓣下组 织，在介入环中瓣球扩外力的作用下，随着锚定支架由第一锚定状态转为第二锚定状态的形变，与腱索和瓣下组织也紧密结合在一起实现最终锚定。与此同时，锚定支架第一锚定状态下，其连接结构心房端固定支杆随着形变为第二锚定状态，固定支杆111向心合围呈轴向平行，使固定支杆端头与连接部心室端的弯折回钩112合力扣住介入环中瓣支架两端的支杆上，这种锚定支架与介入环中瓣尖瓣两端的自动吻扣结构，使介入环中瓣膜与锚定支架精准结合成为一体，确保介入环中瓣的0移位。
本发明所述的分体式可精准锚定的介入环中瓣系统，所述介入人工生物环中瓣，因为有锚定支架结合，其瓣膜的瓣架结构只服务于三瓣叶的合理支撑，包括径向可压缩，并可被球囊扩张后呈圆柱状的钴铬合金支架，或径向可压缩自膨后呈圆柱状的镍钛合金支架，三片设置于所述支架内侧的扇形瓣叶，均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，所述支架为金属网管或可支撑三瓣叶交界固定的各种形态可压握的瓣膜支架。瓣架为钴基合金钴或铬合金或镍钛合金。
本发明一种分体式可精准锚定的介入环中瓣系统还包括输送组件，所述输送组件包括介入环中瓣锚定支架输送套件和介入人工生物环中瓣输送套件，所述介入环中瓣锚定支架输送套件包括输送导管、介入环中瓣锚定支架装载器。所述介入人工生物环中瓣输送套件包括介入人工生物环中瓣输送器、导引鞘、瓣膜压握器和充压泵。所述介入环中瓣锚定支架输送器和介入人工生物环中瓣输送器可经由股静脉穿房间隔、心尖穿刺或左房穿刺入路对二尖瓣成形术后患者二尖瓣失功实施ViR的治疗；也可经股静脉由下腔静脉入路，或经颈静脉或锁骨下静脉由上腔静脉入路对三尖瓣成形术后患者三尖瓣失功实施ViR治疗。
本发明内容总结如下：①分体的锚定支架设计和介入环中瓣分别介入，然后在心内组装结合；②依据术前个性化瓣环及瓣上和瓣下结构影像数据重建的三维真实形态和结构，个性化设计和加工制造特定形态结构的锚定支架；③利用瓣叶交界，通过专设的定位钩袢，准确定位锚定支架的心房面并充填不规则瓣环内缘，人工构建一个规则圆形的锚定支撑结构；④介入环中瓣导入第一锚定状态下锚定支架内释放，借助介入环中瓣释放的球扩外力使锚定支架形变为第二锚定状态，在介入环中瓣可与锚定支架第二锚定状态于瓣环内嵌合成一体，同时实现再次将瓣下组织扣紧，完成最终稳定规则圆形的锚定；⑤锚定支架释放后的第一状态形变随心脏舒缩自动适应性插入、个性化解剖顺位接合、相持和夹合；第二状态下，与介入环中瓣于环内借球扩外科相嵌合的形变过程实现介入环中瓣的释放操控达到自动精准和零移位。
具体地，本发明所采取的技术方案和实施方式是：
1、二尖瓣位实施例
①经心尖路入(参与图17-图18)
经心尖路入多为心外科医生熟悉的实施方式。首先把装载好的锚定支架经心尖路入输送至患者失功的二尖瓣环内，释放定位钩袢,完成定位；顺序释放锚定支架心房面、支架连接结构和心室面， 使心室面锚定钩袢对位结合；撤出锚定支架输送器，沿原路把事先装载好的介入环中瓣输送至锚定支架内，然后通过球囊辅助扩启介入环中瓣，使锚定支架形变为第二锚定状态，实现与介入环中瓣自行精准结合，同时与瓣下组织的扣紧，完成最终锚定。
②经股静脉由右心房穿过房间隔入路(参阅图19-图20)
经股静脉穿房间隔入路为心内科医生熟悉的实施方式。把装载好的锚定支架经股静脉入路，经由下腔静脉入右房，穿房间隔至患者失功的二尖瓣环内，释放定位钩袢完成定位)，顺序释放锚定支架心室面、支架连接结构和心房面，使心室面锚定钩袢对位结合，即为锚定支架的第一锚定状态；撤出锚定支架输送器，沿原路把装载好的介入环中瓣输送至锚定支架内，然后通过球囊辅助扩启介入环中瓣，使锚定支架形变为第二锚定状态，实现与介入环中瓣自行精准结合，同时与瓣下组织形成扣紧并结合，完成最终锚定。
③经复合路入途径，参阅图21-图22。
复合路入方式适合术前经影像分析心脏结构复杂，所设计的介入锚定支架第一状态锚定对位结合牢固性不确定的病例。把装载好的锚定支架经心尖路入送至患者失功的二尖瓣环内，释放定位钩袢定位，顺序释放锚定支架的心房面和连接部，然后释放锚定支架的心室面使锚定钩袢对位结合,即为锚定支架的第一状态，不撤锚定支架输送器以拉住锚定支架；然后，同时经事先已放入导丝的静脉路入，穿房间隔把装载好的介入环中瓣输送至锚定支架内，通过球囊辅助扩启介入环中瓣，使锚定支架形变为第二锚定状态，实现与介入环中瓣自行精准结合，同时与瓣下组织形成夹持扣紧结合，完成最终锚定；撤出介入环中瓣输送器，确认锚定支架第二锚定状态为设计状态并锚定牢固后撤出锚定支架输送器。
三尖瓣位的介入环中瓣系统的实施例，最常见的路入为经股静脉由下腔静脉至右心房达三尖瓣位，其实施例与二尖瓣位②经股静脉由右心房穿过房间隔入路中，经股静脉至右心房相同路径，参阅图23。
本发明的介入环中瓣系统，已经动物实验实施了以上所述的技术方案，业已确认是可行的。
本发明实现的意义在于：①分体式设计，把瓣膜的锚定交给精准设计的锚定支架，使介入环中瓣的瓣膜支架只负责对三个瓣叶的对称支撑，为介入的人工生物瓣满足瓣叶的对称和启闭的同步所必须的、持久稳定的结构保障；②锚定支架和介入环中瓣分别前、后植入，在瓣环内再次紧密结合，确保瓣膜的0移位，同时避免了一体的介入环中瓣结构因结构复杂难以压握和输送困难；③依据术前影像数据三维重建的真实解剖形态和结构个性化设计锚定支架，实现了定位释放可与瓣上和瓣下组织自动适应性结合和夹，重塑规则圆形的预设结构，使介入的瓣膜锚定的更精准；④分体式的设计有望改善和解决因之前植入的瓣膜成形环种类、形态和结构各异所致失功后再介入治疗诸多并发症，以获得更好治疗效果；⑤以上所述的分体式可精准锚定的介入环中瓣系统，每完成一次个性化预设的精准介入环中瓣的治疗过程，对相关数据的分析、介入主动脉瓣锚定支架的形态设计、加 工制造、介入治疗全过程获得的相关数据以及术后随访数据等，作为独立的数据单元，累积大量个性化影像数据、锚定支架设计以及加工制造参数、介入治疗过程及术后结果等相关数据，逐步实现所述分体式可精准锚定介入环中瓣系统，实施介入治疗的智能化与规模化。

Claims (30)

  1. 一种分体式可精准锚定的介入环中瓣系统，其特征在于，
    该系统包括分体的介入环中瓣锚定支架和介入人工生物环中瓣，
    所述介入环中瓣锚定支架的形态和结构与此前植入过瓣膜成形环发生术后瓣膜失功的患者影像数据经三维重建后的瓣环及瓣上和瓣下的真实结构相匹配，所述介入环中瓣锚定支架首先被输送至患者失功瓣环内释放、形变、与失功瓣环的瓣上和瓣下组织对位接合；
    所述介入人工生物环中瓣被输送至所述介入环中瓣锚定支架内释放，所述介入人工生物环中瓣的瓣膜支架形变扩启至介入环中瓣的功能状态，使所述环中瓣锚定支架再次形变与扩启的介入环中瓣结合，同时所述介入环中瓣锚定支架的再次形变致锚定支架与瓣下结构再次结合而锚定。
  2. 根据权利要求1所述的分体式可精准锚定的介入环中瓣系统，其特征在于，所述再次结合锚定为是实现精准规则圆形的预设锚定。
  3. 根据权利要求1所述的分体式可精准锚定的介入环中瓣系统，其特征在于，所述环中瓣系统还包括输送组件，所述输送组件包括介入环中瓣锚定支架输送套件和介入环中瓣输送套件，所述介入环中瓣锚定支架输送套件包括输送导管、介入环中瓣锚定支架装载器。
  4. 根据权利要求1所述的分体式可精准锚定的介入环中瓣系统，其特征在于，所述此前植入过的瓣膜成形环为各类病因二尖瓣关闭不全被植入的各类二尖瓣成形环，或各类病因三尖瓣关闭不全被植入的各类三尖瓣成形环；所述介入环中瓣锚定支架的形态和结构与所之前植入的瓣环的类型和发生术后瓣膜失功的个性化影像数据经三维重建的真实形态和解剖结构精准匹配；所述介入环中瓣锚定支架和介入人工生物环中瓣先后分别路入，然后在体内再组装合二为一，所述介入环中瓣锚定支架的因介入瓣膜释放再次形变与病变二尖瓣或三尖瓣及瓣下组织完成规则圆形的预设锚定，实现介入人工生物环中瓣锚定免于此前植入瓣环形状的应力影响，获得规则圆形锚定的持久稳定。
  5. 根据权利要求1所述的分体式可精准锚定的介入环中瓣系统，其特征在于，所述介入环中瓣为环中二尖瓣和环中三尖瓣。
  6. 根据权利要求1所述的分体式可精准锚定的介入环中瓣系统，其特征在于，所述介入环中瓣锚定支架具有置于导管内的压缩状态、经导管释放后的第一锚定状态和与介入环中瓣结合后的第二锚定状态，
    所述第一锚定状态下，所述环中瓣锚定支架经所述导管释放后形变与患者失功瓣环瓣上和瓣下的组织对位接合；
    所述第二锚定状态下，所述环中瓣锚定支架经介入的环中瓣扩启而二次形变，与介入环中瓣结合同时完成与患者失功瓣环的瓣下组织最终锚定结合。
  7. 根据权利要求6所述的分体式可精准锚定的介入环中瓣系统，其特征在于，所述第二锚定状态下，为所述介入人工生物环中瓣被导管输送至第一状态下的介入环中瓣锚定支架内球扩释放， 球扩外力使环中瓣锚定支二次形变，与被扩启的所述介入人工生物环中瓣结合为一体，实现锚定支架与患者二尖瓣位或三尖瓣位的瓣叶或瓣下的组织完成事先规则圆形的预设锚定。
  8. 根据权利要求6所述的分体式可精准锚定的介入环中瓣系统，其特征在于，所述第一锚定状态下，所述介入环中瓣锚定支架依据此前被植入瓣环的类型、形状和尺寸以及个性化影像数据经三维重建后解剖结构，被加工定形为心房面大、心室面小的圆锥形漏斗状，所述介入环中瓣锚定支架经导管输入并释放后的形变和回形适应患者失功的二尖瓣或三尖瓣的瓣上和瓣下组织个性化对位接合、对持，以重塑规则圆形的预设结构；
    所述第二锚定状态下，在所述第一锚定状态的介入环中瓣锚定支架内，经导管输送导入介入人工生物环中瓣并被球扩释放，与介入环中瓣锚定支架结合为一体，使介入环中瓣锚定支架由原来的圆锥形漏斗状与介入的环中瓣一起被扩为圆柱状，二次形变产生的向心回形夹持，与介入的环中瓣紧密结合的同时完成与患者二尖瓣位或三尖瓣位及瓣下组织紧密的预设锚定。
  9. 根据权利要求1-3任一所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述三维重建的真实结构为数字影像模型或3D打印的仿真实体模型，所述三维重建的真实结构是CT、超声及核磁的综合影像数字化转换后虚拟仿真的三维图像以及相应的3D打印仿真实体模型。
  10. 根据权利要求6任一所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，
    所述环中瓣锚定支架为一伞管形支架结构，包括心房面、心室面和两者之间的锚定支架连接部，所述心房面为伞片状、具有与患者心房面影像数据三维重建的真实形态相匹配的伞片状，即为第一网格部分；所述心室面为多个与瓣叶交界精准对位的定位钩袢；所述锚定支架连接部为圆口漏斗状、具有第二网格部分。
  11. 根据权利要求10所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于所述环中瓣锚定支架连接部第一锚定状态为经导管输送并释放后的第一状态为支架体外的定形记忆状态，所述连接部从心房面到心室面的定形记忆状态具有收缩锥度，所述锥度为5-45度；所述锚定支架的连接部经形变扩张由第一锚定状态变形为圆柱状的第二锚定状态。
  12. 根据权利要求10所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，定位钩袢为两个与患者二尖瓣两瓣叶(二尖瓣环)，或为三个与三尖瓣三个瓣叶(三尖瓣环)交界位置精准对位匹配。
  13. 根据权利要求10所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述介入环中瓣锚定支架的第一锚定状态下，所述定位钩袢经导管先于环中瓣锚定支架心房面释放，插入与之匹配的患者二尖瓣或三尖瓣的瓣叶交界位置，实现定位锚定支架心房面与患者心房形态相匹配；所述介入环中瓣锚定支架形变后第二锚定状态下，所述定位钩袢与所述锚定支架的连接部外周充填于瓣环内与介入环中瓣结合部之间。
  14. 根据权利要求13所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，第二锚定 状态下，所述定位钩袢充填于先前植入瓣环的偏心区域，使环中瓣锚定支架连接部的中轴与先前植入瓣环的中心同轴。
  15. 根据权利要求10所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述环中瓣锚定支架心室面具有数个锚定钩袢，自连接部延伸至心室面后翻折，与患者失功瓣膜的瓣下影像数据三维重建的真实瓣下组织形态相匹配。
  16. 根据权利要求15所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述环中瓣锚定支架第一锚定状态下，所述锚定钩袢经导管释放后，于患者失功瓣环下组织对位，所述环中瓣锚定支架第二锚定状态下，所述多个锚定钩袢通过形变与环中瓣锚定支架的心房面和连接部合力作用形成夹持部，所述多个形变后的锚定钩袢与患者失功瓣环下的瓣叶及瓣下组织交织而紧密结合。
  17. 根据权利要求10所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述锚定钩袢为2-9个，优选为4-6个。
  18. 根据权利要求10所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述环中瓣锚定支架的连接部的心房面端部设置有用于嵌入介入环中瓣支架的多个固定支杆或支架弯折，所述固定支杆或支架弯折，沿心房面方向轴向延伸，其端部朝向锚定支架的轴心弯折。
  19. 根据权利要求10所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述环中瓣锚定支架的连接部设置有用于嵌入介入环中瓣支架流出端若干端头向心弯折，这些向心弯折与所述环中瓣锚定支架的连接部心房面端部设置用于嵌入介入环中瓣支架心房端的多个固定支杆或弯折上下合围与锚定支架形成嵌合成为一体，确保介入环中瓣释放零移位。
  20. 根据权利要求19所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述固定支杆或支架弯折为3-12个，优选为6-9个。
  21. 根据权利要求10所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述环中瓣锚定支架第一网格部分和第二网格部分为由可压缩的菱形网格、V形网格和/或六边形或多边形网格构成的单元网格形成，所述第一网格部分与第二网格部分适应性连接。
  22. 根据权利要求6所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述心房面的网格部分的外周缘与患者心房壁间隔1-2mm，优选间隔1.5mm。
  23. 根据权利要求6所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述第二网格部分的内周缘直径与介入式人工生物环中瓣各种相应大小规格的外径相匹配。
  24. 根据权利要求1-3任一所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述环中瓣锚定支架表面被覆有一层医用高分子薄膜。
  25. 根据权利要求1-3任一所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述环中瓣锚定支架的心房面、心室面和锚定支架的连接部为激光一体切割后三维成形结构或分体连 接结构。
  26. 根据权利要求1-3任一所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，所述锚定支架为具有形状记忆可回形性能的金属材料或非金属材料，所述锚定支架为镍钛合金材质。
  27. 根据权利要求1所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，介入人工生物环中瓣包括径向可压缩，并可被球囊扩张后呈圆柱状的钴铬合金支架，或径向可压缩自膨后呈圆柱状的镍钛合金支架，三个设置于所述支架内侧的扇形瓣叶，三个所述扇形瓣叶均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，所述支架为金属网管。
  28. 根据权利要求22所述的分体式可精准锚定的人工生物环中瓣系统，其特征在于，瓣架为钴基合金钴或铬合金或镍钛合金。
  29. 根据权利要求1-2所述的分体式可精准锚定的介入环中瓣系统，其特征在于，所述介入环中瓣锚定支架输送器和介入人工生物环中瓣输送器，对于三尖瓣环中瓣可经股静脉由下腔静脉入路，或经颈静脉或锁骨下静脉由上腔静脉输送至三尖瓣位；对于二尖瓣环中瓣可经心尖或经左心房或经股静脉过房间隔入路至二尖瓣位。
  30. 根据权利要求1-26所述的分体式可精准锚定的介入环中瓣系统，其特征在于，每完成一次针对个性化预设实现精准塑形锚定的介入环中瓣治疗过程，所有上述相关数据作为独立的数据单元，累积大量个性化的数据单元，通过大数据的算法以及AI实现所述分体式可精准锚定介入环中瓣系统的智能化、规模化与产业化。
PCT/CN2022/132662 2021-11-17 2022-11-17 一种分体式可精准锚定的介入环中瓣系统 WO2023088392A1 (zh)

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