WO2023184639A1 - 抗反流心脏瓣膜支架 - Google Patents

抗反流心脏瓣膜支架 Download PDF

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Publication number
WO2023184639A1
WO2023184639A1 PCT/CN2022/089819 CN2022089819W WO2023184639A1 WO 2023184639 A1 WO2023184639 A1 WO 2023184639A1 CN 2022089819 W CN2022089819 W CN 2022089819W WO 2023184639 A1 WO2023184639 A1 WO 2023184639A1
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WO
WIPO (PCT)
Prior art keywords
heart valve
reflux
valve stent
arc
distal end
Prior art date
Application number
PCT/CN2022/089819
Other languages
English (en)
French (fr)
Inventor
吴明明
王春光
陈海琴
陈大凯
Original Assignee
科凯(南通)生命科学有限公司
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Publication of WO2023184639A1 publication Critical patent/WO2023184639A1/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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets

Definitions

  • the invention relates to the technical field of medical devices, and in particular to an anti-reflux heart valve stent.
  • transcatheter surgery has many advantages such as less trauma and faster recovery, more and more surgeries are being performed through transcatheter surgery.
  • Aortic valve replacement has also changed from the early surgical method to transcatheter aortic valve replacement. Therefore, it is necessary to provide a heart valve stent that can be used for transcatheter aortic valve replacement, is easy to fix, and is firmly fixed.
  • the Chinese invention patent with authorization announcement number CN102413793B and titled "Stent for positioning and anchoring of valve prosthesis at the implantation site in the patient's heart” discloses an expandable stent that includes multiple positioning arcs and multiple a retaining arc configured to be located within a plurality of pockets on the native heart valve and on a first side of a plurality of native heart valve leaflets, the plurality of retaining arcs configured to be located opposite the first side on the second side of the plurality of native heart valve leaflets.
  • the retaining arc is divided into a plurality of arm segments by a plurality of curved edges, and the arm segments are interconnected to form a retaining arc arm, which is in a straight line when the stent is in an unexpanded state.
  • Each arm of the retaining arc has a shape that matches the leaflet of the valve prosthesis attached to the stent.
  • the native valve leaflets are directly sandwiched between the positioning member and the fastening arc, and there is a risk that the native heart valve leaflets will interfere with the artificial heart valve leaflets.
  • aortic valve replacement is usually completed with the help of anti-reflux cardiac stents and delivery devices, and one of the technical challenges that needs to be solved is how to fix the native heart valve leaflets.
  • the native heart valve leaflets are sandwiched between the positioning member and the fastener of the anti-reflux heart stent, which requires the positioning member to have an appropriate opening angle when the anti-reflux heart stent is in an expanded state.
  • the positioning member is usually a curved rod, with both ends fixedly connected to the connecting blocks of the anti-reflux cardiac stent, most of it is in a suspended state after expansion, making it difficult to control the radial expansion angle of the positioning member.
  • the heart valve stent is one of the key devices for heart valve replacement surgery, and the heart valve stent is usually made of medical stainless steel.
  • the connection structure density at the distal end of the heart valve stent in the prior art is relatively high, which increases the burden on the heart valve.
  • the weight of the stent on the one hand, makes the heart valve stent more difficult to handle, and on the other hand, it also increases the material cost.
  • the purpose of this application is to provide an anti-reflux heart valve stent.
  • the present invention provides the following technical solutions.
  • the present application provides an anti-reflux heart valve stent, including a distal end of the anti-reflux heart valve stent close to the apex when the anti-reflux heart valve stent is in an extended state and a distal end of the anti-reflux heart valve stent.
  • the proximal end of the anti-reflux heart valve stent is away from the cardiac apex, and is characterized in that the anti-reflux heart valve stent is constructed to effectively prevent the native heart valve leaflets from intruding on the artificial heart valve leaflets.
  • the present application provides an anti-reflux heart valve stent, including a distal end of the anti-reflux heart valve stent close to the apex when the anti-reflux heart valve stent is in an extended state and a distal end of the anti-reflux heart valve stent.
  • the proximal end of the anti-reflux heart valve stent is away from the cardiac apex when the stent is in an extended state. It is characterized in that the proximal end of the anti-reflux heart valve stent includes a connecting piece and a supporting piece, a positioning piece and a positioning piece arranged between adjacent connecting pieces. Fasteners used to fix artificial heart valve leaflets;
  • the support member includes a first support arm, a second support arm and a distal end of the support member connecting the first support arm and the second support arm, and the first support arm is fixedly connected to the first connecting member , the second support arm is fixedly connected to the second connecting piece, the first connecting piece is adjacent to the second connecting piece;
  • the positioning member includes a first positioning arm, a second positioning arm and a distal end of the positioning member connecting the first positioning arm and the second positioning arm.
  • the first positioning arm is fixedly connected to the first connecting member.
  • the second positioning arm is fixedly connected to the second connecting piece, the first connecting piece is adjacent to the second connecting piece;
  • the fastener includes a first fastening arc, a second fastening arc and a distal end of the fastener connecting the first fastening arc and the second fastening arc, the first fastening arc Fixedly connected to a first connecting piece, the second fastening arc is fixedly connected to a second connecting piece, the first connecting piece being adjacent to the second connecting piece;
  • the positioning member is closer to the distal end of the anti-reflux heart valve stent than the support member, the fastener is closer to the distal end of the anti-reflux heart valve stent than the positioning member, and the support
  • the distal end of the member and the distal end of the positioning member are rods that protrude toward the distal end of the anti-reflux heart valve stent, the support member is disposed on one side of the native heart valve leaflets, and the positioning member is disposed on the native heart valve leaflet. The other side of the heart valve leaflets.
  • the first support arm and the second support arm are linear when the anti-regurgitation heart valve stent is in a compressed state.
  • the first positioning arm and the second positioning arm are linear when the anti-regurgitation heart valve stent is in a compressed state.
  • the distal end of the positioning member has a parabolic structure.
  • the support member has a first opening angle
  • the positioning member has a second opening angle
  • the second opening angle is 4°- 14°
  • the first opening angle is smaller than the second opening angle
  • the vertical distance between the distal end of the positioning member closest to the distal end of the anti-reflux heart valve stent and the farthest distal end of the anti-reflux heart valve stent is 4 mm to 8 mm, preferably 6 mm.
  • the connecting piece includes a connecting block, a connecting web and a connecting frame.
  • One end of the connecting block forms the proximal end of the anti-reflux heart valve stent, and the other end is connected to the connecting frame through the connecting web.
  • the connection frame sequentially includes a support connection part, a positioning part connection part and a fastener connection part.
  • the width of the connecting web is smaller than the width of the connecting block and smaller than the width of the connecting portion of the support.
  • connection frame includes a hollow elongated suture hole.
  • the positioning member includes a pull wire composite ring
  • the pull wire composite ring is fixedly connected to the positioning member, and is located on a side of the positioning member facing the proximal end of the anti-reflux heart valve stent, the pull wire composite ring
  • the ring includes a first through hole and a second through hole, the first through hole is used to install the mark, the second through hole is suitable for penetrating the pull wire, and the second through hole is larger than the first through hole. Proximal to the anti-reflux heart valve stent.
  • the diameter of the first through hole is larger than the diameter of the second through hole.
  • the positioning member includes a pull wire composite ring
  • the pull wire composite ring is fixedly connected to the positioning member, and is located on a side of the positioning member facing the proximal end of the anti-reflux heart valve stent, the pull wire composite ring
  • the ring includes a second through hole adapted to pass the pull wire and is configured to be identifiable by X-rays.
  • the surface of the wire-stayed composite ring is provided with an X-ray opaque marking layer or a high-density metal plating layer; or,
  • the outer contour of the wire-staying composite ring is set to one or more of a gourd shape, a triangular star shape, a prism shape or a cat's claw shape.
  • the pull wire composite ring is disposed at the distal end of the positioning member and is inclined inward relative to the axis of the stent.
  • the support member includes a support member pull wire loop adapted to penetrate a pull wire, the support member pull wire loop is fixedly connected to the support member, and is located at the distal end of the support member toward the anti-reflux heart valve stent. side.
  • the position of the support wire ring is aligned with the position of the wire composite ring.
  • the support member cable loop is tilted outward relative to the support member.
  • the support member cable loop is tilted outward at an angle of 100°-160° relative to the support member.
  • the present application provides an anti-reflux heart valve stent, including a distal end of the anti-reflux heart stent close to the apex when the anti-reflux heart stent is in an extended state;
  • the proximal end of the anti-reflux cardiac stent is far away from the apex of the heart.
  • the proximal end of the anti-reflux cardiac stent includes a connecting piece and a positioning piece and a fastener arranged between adjacent connecting pieces. The feature is that the fastening The positioning member is closer to the distal end of the anti-reflux heart stent than the positioning member.
  • the distal end of the positioning member is a rod protruding toward the distal end of the anti-reflux heart stent.
  • the positioning member is arranged on the native heart valve leaflet. one side, and the fastener is disposed on the other side of the native heart valve leaflet;
  • the positioning member includes a pull wire composite ring, which is fixedly connected to the positioning member and located on a side of the positioning member facing the proximal end of the anti-reflux cardiac stent;
  • the anti-reflux heart valve stent further includes a support member, the support member includes a first support arm, a second support arm and a distal end of the support member connecting the first support arm and the second support arm, the The first support arm is fixedly connected to the first connecting piece, the second supporting arm is fixedly connected to the second connecting piece, and the first connecting piece is adjacent to the second connecting piece;
  • a connection mechanism is provided between the distal end of the support member and the pull wire composite ring.
  • the connecting mechanism is a connecting rod or a folded line structure.
  • the connecting mechanism includes a first connecting rod, a second connecting rod and a diamond-shaped square connecting the first connecting rod and the second connecting rod.
  • One end of the first connecting rod is fixedly connected to the cable composite ring, and the The other end of the second link is fixedly connected to the support member, and the longitudinal axis of the first link and the longitudinal axis of the second link are on the same straight line.
  • the length of the first connecting rod is smaller than the length of the second connecting rod.
  • the connecting mechanism includes a first connecting rod, a second connecting rod and a curved connection portion for connecting the first connecting rod and the second connecting rod, wherein one end of the first connecting rod is connected with a grid.
  • Rod I the other end of the grid connecting rod I is fixedly connected to the grid connecting rod II, and the other end of the grid connecting rod II is fixedly connected to one end of the second connecting rod.
  • the grid connecting rod I is connected to the grid connecting rod I.
  • Rod II is fixedly connected through a curved connection part, wherein the width of the curved connection part is smaller than the width of grid connecting rod I and grid connecting rod II.
  • connection structure adopts an S-shaped structural design, in which the first connecting rod is fixedly connected to the second connecting rod through three connecting rods.
  • the present application provides an anti-reflux heart valve stent, characterized in that the proximal end of the anti-reflux heart valve stent includes a connecting piece and a positioning piece and a fastener disposed between adjacent connecting pieces. , the fastener is used to fix the leaflets of the artificial heart valve;
  • the fastener includes a first fastening arc, a second fastening arc, and a distal end of the fastener connecting the first fastening arc and the second fastening arc;
  • the distal end of the anti-reflux heart valve stent includes a latching end, and the latching end includes a plurality of interconnected latching end structural units.
  • the width of the rods constituting the latching end structural units is smaller at the center and larger at the two ends.
  • the blocking end structural unit is a diamond-shaped square grid, and the blocking end includes 18 blocking end structural units arranged in one layer and connected to each other.
  • the connecting areas of adjacent latching end structural units respectively extend a predetermined length along the circumferential and longitudinal directions of the anti-reflux heart valve stent.
  • the phase The connection area of the structural unit adjacent to the clamping end includes a curved structure that is recessed toward it.
  • a reinforcing mesh is provided between the clamping end and the fastener, the distal end of the reinforcing mesh is fixed to the clamping end, and the proximal end of the reinforcing mesh is fixedly connected to the adjacent fastener. between different fastening arcs of parts.
  • the reinforcing mesh includes a plurality of interconnected reinforcing mesh structural units, the reinforcing mesh structural unit on the proximal side of the reinforcing mesh is fixedly connected to the second fastening arc of the first fastener, and the reinforcing mesh The reinforcing mesh structural unit on the other side of the proximal end is fixedly connected to the first fastening arc of the second fastener.
  • the reinforcing mesh includes a first self-expanding arc, a second self-expanding arc and a third self-expanding arc arranged sequentially in a direction from the distal end of the heart valve stent to the proximal end of the heart valve stent;
  • one end of the first self-expanding arc is fixedly connected to the first fastening arc of the fastener, and the other end is fixedly connected to the second fastening arc of the adjacent fastener, and protrudes toward the distal end of the heart valve stent.
  • both ends of the second self-expanding arc are respectively fixedly connected to the first self-expanding arc and protrude toward the proximal end of the heart valve stent;
  • One end of the third self-expanding arc is fixedly connected to the first fastening arc of the fastener, and the other end is fixedly connected to the second fastening arc of the adjacent fastener, and protrudes toward the distal end of the heart valve stent. ;
  • the first fastening arc of the fastener and the second fastening arc of the adjacent fastener form a first rounded angle;
  • the second self-expanding arc has a second rounded angle,
  • the third self-expanding arc has a third rounded corner, where the third rounded corner does not allow the first rounded corner, and the second rounded corner is larger than the first rounded corner.
  • the reinforcing net is composed of a curved self-expanding arc, a connecting grid and a third self-expanding arc, wherein the curved self-expanding arc is composed of four sections, namely curved arm I, curved arm II, curved arm III, curved arm.
  • Arm IV in which the curved arms I and IV are respectively connected to the fastening arc at 0.25 to 0.33 near the distal end, in which the distal ends of the curved arms I and II are fixedly connected, and the connection is connected to the clamping end, in which the curved arm
  • the distal ends of arm III and curved arm IV are fixedly connected, and the connection is connected to the clamping end.
  • the proximal ends of curved arm II and curved arm III are fixedly connected, and the connection is fixedly connected to the connecting grid.
  • the connecting grid includes two connecting arms. .
  • the coupling arm of the coupling grid is provided with at least one coupling hole suitable for the pulling wire to pass through.
  • the clamping end structural unit is a diamond-shaped structure.
  • the reinforcing mesh structural unit at the far end of the reinforcing mesh shares a vertex with a clamping end structural unit at the clamping end.
  • the reinforcing mesh structural unit at the far end of the reinforcing mesh and the fastener The fastening arcs share one or two edges.
  • the width of the rods constituting the reinforcing mesh structural unit is smaller in the center and larger at the two ends.
  • the reinforcing mesh sequentially includes three interconnected layers, the first layer includes a reinforcing mesh structural unit, and the second layer includes a reinforcing mesh structural unit.
  • the first layer includes two reinforced mesh structural units, and the third layer includes one reinforced mesh structural unit;
  • the reinforcing mesh structural unit of the first layer shares an edge with the second fastening arc of the fastener on its left side, and shares an edge with the first fastening arc of the fastener on its right side;
  • the reinforced mesh structural unit on the left side of the second layer shares an edge with the second fastening arc of the fastener on its left side
  • the reinforced mesh structural unit on the right side of the second layer shares the first fastening arc of the fastener on its right side.
  • Arcs share an edge
  • the reinforced mesh structural unit of the third layer shares a vertex with the clamping end structural unit.
  • the reinforcing mesh structural unit connection areas of the second layer of the reinforcing mesh extend a predetermined length along the circumferential and longitudinal directions of the anti-reflux heart valve stent respectively, and along the circumferential direction of the anti-reflux heart valve stent,
  • the reinforcing mesh structural unit connection area includes a curved structure that is concave toward it.
  • the density of the reinforcing mesh is such that each fastener corresponds to one reinforcing mesh.
  • the anti-reflux heart valve stent further includes a mesh-like coating, and the mesh-like coating is fixed on the inside of the anti-reflux heart valve stent.
  • the mesh-like covering is fixed to the anti-reflux heart valve stent by sewing with each component of the anti-reflux heart valve stent.
  • the grid-like coating is woven from longitudinal threads and transverse threads, and the angle between the longitudinal threads and the transverse threads is set to 60° to 90°.
  • the anti-reflux heart valve stent further includes an artificial valve leaflet
  • the artificial valve leaflet includes an artificial valve leaflet main body, an ear portion and a fastener
  • the outer contour of the artificial valve leaflet main body includes an artificial valve leaflet facing toward the artificial valve leaflet.
  • the concave area of the leaf is the concave area of the leaf.
  • the artificial valve leaflet further includes an anti-wear edge strip, and the anti-wear edge strip is provided on the outer contour of the artificial valve leaflet main body.
  • the artificial valve leaflet is fixed to the connection member of the anti-reflux heart valve stent by a wavy suture or a surrounding suture.
  • the support member Since the native valve leaflets are clamped by the support member and the positioning member, the clamping is relatively more reliable. At the same time, the support member also facilitates the self-expansion of the heart valve stent more smoothly, increasing the radial force during self-expansion.
  • Figure 1 shows a perspective view of a heart valve stent in an extended state according to an embodiment of the present application.
  • Figure 2 shows a perspective view of the heart valve stent shown in Figure 1 from another angle.
  • Figure 3 shows an expanded view of the heart valve stent shown in Figure 1.
  • Figure 4 shows a partial enlarged view of area B in Figure 3.
  • FIG. 5 shows a partial enlarged view of area C in FIG. 3 .
  • FIG. 6 shows a perspective view of the heart valve stent shown in FIG. 1 after the artificial heart valve leaflets are installed and in an extended state.
  • FIG. 7 shows a top view of the perspective view shown in FIG. 6 .
  • Figure 8 shows a perspective view of a heart valve stent in an extended state according to another embodiment of the present application.
  • FIG. 9 shows a perspective view of the heart valve stent shown in FIG. 8 including pull wires.
  • Figure 10 shows a perspective view of an anti-reflux cardiac stent in an extended state according to an embodiment of the present application.
  • Figure 11 shows an expanded view of the anti-reflux cardiac stent shown in Figure 1 .
  • FIG. 12 shows a partial enlarged view of area B in FIG. 2 .
  • FIG. 13 shows a partial enlarged view of area C in FIG. 2 .
  • Figure 14A shows a schematic view I of a connection mechanism according to another embodiment.
  • Figure 14B shows a schematic diagram II of a connection mechanism according to another embodiment.
  • Figure 14C shows a schematic diagram III of a connection mechanism according to another embodiment.
  • Figure 14D shows a partial enlarged view of area B in Figure 14A.
  • Figure 15 shows a perspective view of an anti-reflux heart stent with artificial heart valve leaflets installed.
  • Figure 16 shows a perspective view of an anti-reflux heart valve stent in an extended state according to another embodiment.
  • Figure 17 shows an expanded view of the anti-reflux cardiac stent shown in Figure 16.
  • FIG. 18 shows a partial enlarged view of area A in FIG. 17 .
  • FIG. 19 shows a partial enlarged view of area B in FIG. 17 .
  • Figure 20 shows a perspective view of an anti-reflux heart valve stent in an extended state according to another embodiment.
  • Figure 21 shows an expanded view of the anti-reflux cardiac stent shown in Figure 20.
  • FIG. 22 shows a partial enlarged view of area A in FIG. 21 .
  • FIG. 23 shows a partial enlarged view of area B in FIG. 21 .
  • Figure 24 shows a perspective view of an anti-reflux heart valve stent in an extended state according to another embodiment.
  • Figure 25 shows an expanded view of the anti-reflux cardiac stent shown in Figure 24.
  • FIG. 26 shows a partial enlarged view of area A in FIG. 25 .
  • Figure 27 shows a perspective view of an anti-reflux heart valve stent in an extended state according to another embodiment.
  • FIG. 28 shows a partial enlarged view of area A in FIG. 25 .
  • Figure 29A shows a guyed composite ring according to another embodiment.
  • Figure 29B shows a guyed composite ring according to another embodiment.
  • Figure 29C shows a guyed composite ring according to another embodiment.
  • Figure 29D shows a guyed composite ring according to another embodiment.
  • Figure 30 shows a perspective view of an anti-reflux heart valve stent in an extended state according to another embodiment.
  • FIG. 31 shows a partial enlarged view of area A in FIG. 30 .
  • Figure 32 shows an expanded view of the anti-reflux cardiac stent shown in Figure 30.
  • FIG. 33 shows a partial enlarged view of area A in FIG. 32 .
  • FIG. 34 shows a partial enlarged view of area B in FIG. 32 .
  • Figure 35 shows a perspective view of an anti-reflux heart valve stent in an extended state according to another embodiment.
  • FIG. 36 shows a partial enlarged view of area A in FIG. 35 .
  • Figure 37 shows an expanded view of the anti-reflux cardiac stent shown in Figure 35.
  • FIG. 38 shows a partial enlarged view of area A in FIG. 37 .
  • FIG. 39 shows a partial enlarged view of area B in FIG. 37 .
  • FIG. 40 shows a perspective view of an anti-reflux heart valve stent in an extended state after installation of a mesh membrane according to another embodiment.
  • Figure 41 shows a perspective view of the anti-reflux heart valve stent in an extended state after installing a prosthetic valve leaflet according to yet another embodiment.
  • Figure 42 shows a schematic diagram of a mesh-like coating according to one embodiment.
  • Figure 43 shows a schematic diagram of an artificial valve leaflet according to one embodiment.
  • FIG. 44 shows a partial enlarged view of the recessed area in FIG. 43 .
  • Figure 45 shows a schematic diagram of an artificial valve leaflet according to another embodiment.
  • Figure 46 shows a schematic diagram of an artificial valve leaflet according to another embodiment.
  • Figure 47 shows a perspective view of the anti-reflux heart valve stent in an extended state after installing the artificial valve leaflets according to yet another embodiment.
  • Figure 48 shows a partial enlarged view of area A in Figure 47.
  • Figure 49 shows a perspective view of the anti-reflux heart valve stent in an extended state after installing the artificial valve leaflets according to yet another embodiment.
  • Figure 50 shows a partial enlarged view of area A in Figure 49.
  • first”, “second”, etc. are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features. Thus, features defined by “first,” “second,” etc. may explicitly or implicitly include one or more of such features. In the description of the present invention, unless otherwise specified, "plurality" means two or more.
  • connection should be understood in a broad sense.
  • it can be connected or detachably connected. , or integrally connected; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two components.
  • connection should be understood in a broad sense.
  • it can be connected or detachably connected. , or integrally connected; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two components.
  • proximal refers to the side of the delivery device or in the direction of the user-manipulated end when the heart valve stent is in an extended state.
  • distal end refers to the side away from the delivery device or the side away from the end manipulated by the user when the heart valve stent is in the extended state.
  • proximal end refers to the side close to the apex of the heart when the heart valve stent is in an extended state.
  • distal end refers to the side away from the cardiac apex when the heart valve stent is in an extended state.
  • This embodiment provides a heart valve stent.
  • the heart valve stent of this embodiment will be described in detail below with reference to Figures 1-7.
  • FIGS. 1-3 show a perspective view of the heart valve stent 1 according to Embodiment 1 when it is in an extended state
  • FIG. 2 shows a perspective view of the heart valve stent 1 according to this embodiment from another angle
  • FIG. 3 shows a perspective view of the heart valve stent 1 according to this embodiment.
  • the heart valve stent 1 in this embodiment may include a distal end of the heart valve stent close to the apex when the heart valve stent is in an extended state and a distal end far away from the apex when the heart valve stent is in an extended state.
  • the proximal end of the heart valve stent may include a connecting member 14 and a supporting member 11, a positioning member 12 and a fastener 13 disposed between adjacent connecting members.
  • the support member 11 and the positioning member 12 can be used to fix the native heart valve leaflets, while the fastener 13 can be used to fix the artificial heart valve leaflets.
  • the support member 11 may include a first support arm 111, a second support arm 112, and a support distal end 113 connecting the first support arm 111 and the second support arm 112.
  • the first support arm 111 is fixedly connected to the first connecting piece
  • the second supporting arm 112 is fixedly connected to the second connecting piece
  • the first connecting piece is adjacent to the second connecting piece.
  • the positioning member 12 may include a first positioning arm 121, a second positioning arm 122, and a positioning member distal end 123 connecting the first positioning arm and the second positioning arm.
  • the first positioning arm 121 is fixedly connected to the first connecting piece
  • the second positioning arm 122 is fixedly connected to the second connecting piece, and the first connecting piece is adjacent to the second connecting piece.
  • the fastener 13 includes a first fastening arc 131, a second fastening arc 132, and a fastener distal end 133 connecting the first fastening arc and the second fastening arc.
  • the first fastening arc is fixedly connected to the first connecting piece
  • the second fastening arc is fixedly connected to the second connecting piece
  • the first connecting piece is adjacent to the second connecting piece.
  • the positioning member 12 is closer to the distal end of the heart valve stent than the support member 11
  • the fastener 13 is closer to the distal end of the heart valve stent than the positioning member 12
  • the distal end 113 of the support member and the distal end 123 of the positioning member are rods protruding toward the distal end of the heart valve stent.
  • the support member 11 is disposed on one side of the native heart valve leaflets
  • the positioning member 12 is disposed on the other side of the native heart valve leaflets.
  • the heart valve stents described herein also include a support member 11, so that the native valve leaflets can be sandwiched between the support member 11 and the positioning member 12.
  • the support member 11 prevents the native valve leaflets from intruding on the artificial valve.
  • the support member also facilitates the self-expansion of the heart valve stent more smoothly, increasing the radial force during self-expansion. .
  • the first support arm and the second support arm are linear.
  • the first positioning arm and the second positioning arm are linear.
  • the first positioning arm and the second positioning arm are designed to be linear to facilitate compression. When fully compressed, they occupy the smallest space, that is, the adjacent first support arm and the second support arm will be fully close together when compressed.
  • the linear structure can ensure that the two will not interfere during compression. Therefore, the purpose of the first positioning arm and the second positioning arm being linear is also to fully close together without interference during compression.
  • this bracket is cut from a steel pipe.
  • the linear design also facilitates processing, shortens the processing path, and reduces processing costs.
  • the distal end of the positioning member has a parabolic structure, which reduces the contact stress between the positioning member and the sinus bottom and prevents the annulus from rupturing.
  • the width of the fastener 13 is wider than the width of the support member 11 and the positioning member 12 to provide strong support.
  • the support member when the heart valve stent is in an extended state, the support member has a first opening angle, the positioning member has a second opening angle, and the second opening angle is 4 °-14°, and the first opening angle is smaller than the second opening angle.
  • the positioning member 12 and the fastener 13 create a certain opening angle, which facilitates the positioning member 12 to capture the valve leaflets and reduces the difficulty of the operation.
  • the positioning member 12 can be used to prevent the valve from shifting in the ventricular direction, and promote the distal end of the artificial valve leaflet to align with the native valve leaflet, so as to restore the function of the native valve to the greatest extent, while maintaining the artificial valve in the position of the original native valve.
  • the artificial valve can replace the native valve very well, reducing the impact on blood flow and reducing the occurrence of thrombus, and the setting of the second opening angle of 4°-14° can make the positioning member 12 and the fastener 13 It can clamp the native valve to prevent the native valve from moving freely.
  • the native valve leaflets and the stent are closely attached, reducing paravalvular leakage.
  • the vertical distance between the distal end of the positioning member closest to the distal end of the heart valve stent and the farthest distal end of the heart valve stent is 4mm-8mm, preferably 6mm.
  • the distal end of the latching end is outwardly expanded relative to the proximal end of the latching end, and the angle at which the distal end of the latching end is outwardly expanded relative to the proximal end of the latching end is 6°-14°.
  • the reason for the need for external expansion is to prevent the lightweight heart valve stent from displacing toward the aorta and acting as an anchor. At the same time, the reason for not creating an excessively large angle is to prevent contact with the His bundle, thereby affecting the normal beating of the heart and endangering life.
  • the distal end of the heart valve stent also includes a latching end 16 and a reinforcing mesh 15, and a hollow structure 17 exists between the latching end 16 and the reinforcing mesh 15.
  • the number of rhombus-shaped squares at the locking end 16 is 18, which effectively increases the compressibility of the heart valve stent, and the width of the rods constituting the rhombus-shaped squares is gradual (thin in the middle and wide at both ends), so that Optimize the fatigue resistance of the bracket.
  • the heart valve stent described in this article only includes 18 diamond-shaped squares
  • the heart valve stent only needs a reinforcing mesh 15 between adjacent fastening arcs to connect the clamping ends, which can form a large number of hollow parts, effectively It reduces the weight of the heart valve stent and is easy to compress, and the width of the rods forming a diamond-shaped square is gradually changed (thin in the middle and wide at both ends) to optimize the fatigue resistance of the stent.
  • the presence of the reinforcing mesh 15 can not only increase the structural strength of the middle part of the stent, but also isolate the autogenous valve leaflets to prevent infringement of the artificial valve leaflets.
  • the distal end of the lightweight heart valve stent may include a latching end 16 , which includes a plurality of latching end structural units 161 connected to each other to form the latching end structure.
  • the width of the rod 162 of the unit 161 is smaller in the center and larger at the two ends.
  • the rod 162 of the locking end structural unit 161 may be symmetrical, with the width in the middle being the smallest, and then smoothly becoming larger toward both ends without a stepwise mutation. The edges of rod 162 are therefore smooth.
  • the blocking end structural unit 161 is a diamond-shaped square grid, and the blocking end 16 may include 18 blocking end structural units 161 arranged in one layer and connected to each other. Adjacent card end structural units 161 can be connected to each other by sharing a vertex.
  • the connection areas of the adjacent latching end structural units 161 respectively extend a predetermined length along the circumferential and longitudinal directions of the lightweight heart valve stent. Along the circumferential direction of the lightweight heart valve stent, the adjacent latching ends
  • the structural unit connection area includes a curved structure 163 recessed towards it.
  • the width of both ends of the rod 162 is the widest, the position of the rod 162 near the connecting area of the blocking end structural unit 161 is the widest and the most difficult to deform. Therefore, greater stress will be generated during the process of compression and expansion, and it is easy to As a result, the rod 162 is broken near the connection area of the blocking end structural unit 161 .
  • the bending stress of the rod 62 near the connection area of the clamping end structural unit 161 is reduced, and the compression and self-expansion process of the clamping end of the stent can be prevented to prevent the rod 162 from breaking.
  • a reinforcing mesh 15 is provided between the clamping end 16 and the fastener 13, and the distal end of the reinforcing mesh 15 is fixed to the clamping position. End 16 , the proximal end of the reinforcing mesh 15 is fixedly connected between different fastening arcs of adjacent fasteners 13 .
  • the reinforcing mesh 15 includes a plurality of interconnected reinforcing mesh structural units 151, and the reinforcing mesh structural unit 151 on the proximal side of the reinforcing mesh is fixedly connected to the second part of the first fastener.
  • the clamping end structural unit 151 is a diamond-shaped structure, and the reinforcing mesh structural unit at the far end of the reinforcing mesh shares a vertex with a clamping end structural unit at the distal end.
  • the structural unit and the fastening arc of the fastener share one or two edges.
  • the width of the rods 152 constituting the reinforcing mesh structural unit 151 is smaller in the center and larger at the two ends.
  • the reinforcing mesh 15 sequentially includes three interconnected layers, and the first layer includes a As for the reinforced mesh structural unit, the second layer includes two reinforced mesh structural units, and the third layer includes one reinforced mesh structural unit.
  • the reinforcing mesh structural unit of the first layer shares an edge with the second fastening arc of the fastener on its left side, and shares an edge with the first fastening arc of the fastener on its right side.
  • the reinforced mesh structural unit on the left side of the second layer shares an edge with the second fastening arc of the fastener on its left side, and the reinforced mesh structural unit on the right side of the second layer shares the first fastening arc of the fastener on its right side.
  • the reinforced mesh structural unit of the third layer shares a vertex with the clamping end structural unit.
  • the reinforcing mesh structural unit connection areas of the second layer of the reinforcing mesh extend for a predetermined length respectively along the circumferential and longitudinal directions of the lightweight heart valve stent, and along the circumferential direction of the lightweight heart valve stent.
  • the reinforcing mesh structural unit connection area includes a curved structure 153 recessed toward it.
  • the function of the bending structure 153 in the connection area of the reinforcing mesh structural unit is similar to that of the bending structure 163 in the connection area of the structural unit at the clamping end. It can prevent the rod 152 from breaking during the compression and self-expansion process of the clamping end of the bracket.
  • the connecting member 14 may include a connecting block 141 , a connecting web 142 and a connecting frame 143 .
  • One end of the connecting block 141 forms the proximal end of the heart valve stent, and the other end is connected to the connecting frame 143 through the connecting web 142.
  • the connecting block 141 is for connecting with a conveyor that transports the heart valve stent.
  • the connection frame 143 may include a support connection part, a positioning part connection part and a fastener connection part in sequence.
  • the support connection portion may be symmetrical, with one side connected to the first support arm of the first support member and one side connected to the second support arm of the adjacent second support member.
  • the upper edge of the connection point between the support arm and the connecting frame is a smooth arc, and the angle of the arc is 100°-160°.
  • the lower edge of the connection between the support arm and the connecting frame is also a smooth arc, and the angle of the arc is an acute angle.
  • the support arm of the support member includes point X.
  • the first support arm or the second support arm is bent at point X.
  • the deformation point is away from the connection frame, reducing stress concentration. Because both the support member and the positioning member are connected to the connection frame 143, and the space of the connection frame 143 is limited, if the support connection part and the positioning part connection part in the connection frame are very close to each other.
  • the deformation position of the support member relative to the connection frame and the deformation position of the positioning member relative to the connection frame are both at the connection, and the support member and the positioning member are located on both sides of the valve respectively, so if the deformation positions of the two relative to the connection frame are too If the deformation area is too close, it is easy to produce a large shear force on the native valve close to the connecting frame, thereby damaging the valve. Moreover, if the deformation zone is too close, stress concentration may easily occur, causing the connection between the support/positioning member and the connecting frame to break.
  • the deformation position of the support member relative to the connecting frame is shifted to the X point away from the connecting frame, which solves the problem of easily generating large shear force on the native valve close to the connecting frame.
  • the position of each deformation zone becomes further away, which also prevents the problem of excessive stress concentration.
  • the width of the connecting web is smaller than the width of the connecting block and smaller than the width of the connecting portion of the support.
  • the connection frame includes a hollow elongated suture hole 144 .
  • One end of the elongated suture hole 144 may be provided at the support connection part, and the other end may be provided at the positioning part connection part or the fastener connection part.
  • the elongated suture hole 144 allows the proximal edge of the artificial valve leaflet to be sutured directly through the suture hole without adding a suture gasket, and the edge of the artificial valve leaflet is sutured to the fastening arc. This suturing method is relatively traditional.
  • gaskets and stent extrusion to fix the leaflets first reduces the number of external parts of the stent, and the absence of gaskets is also conducive to further compression of the stent. If there are gaskets, it will not only affect the compression of the stent, but also Even sometimes the prosthetic valve leaflets are damaged when the stent is compressed by a smaller stent.
  • the positioning member may include a pull wire composite ring 124, which is fixedly connected to the positioning member and located on a side of the positioning member facing the proximal end of the heart valve stent,
  • the pull cord composite ring includes a first through hole 1241 and a second through hole 1242.
  • the first through hole is used to install a mark
  • the second through hole is suitable for penetrating the pull cord
  • the second through hole is larger than the The first through hole is closer to the proximal end of the heart valve stent.
  • the diameter of the first through hole is larger than the diameter of the second through hole.
  • the pull-wire composite ring structure provided at the far end of the positioning member 12 combines the installation of the pull-wire and the marker "marker" (the marker is radiopaque) into one position, effectively reducing the space occupied by the product. Using one position, the opening and closing control and positioning of the positioning piece can be realized, which not only improves the compression performance of the product and facilitates the delivery of the product using the catheter, but also helps reduce the difficulty of surgical operations by opening the positioning piece.
  • the pull-wire composite ring structure has two through holes. The large hole is for placing marker points to facilitate accurate positioning of implantation and ensure that the positioning part touches the sinus bottom. The small hole is convenient for penetrating the pull-wire. During the implantation process, the positioning part is controlled by the pull-wire.
  • the pull-wire composite ring is disposed at the distal end of the positioning member and is tilted inward relative to the axis of the stent to prevent the proximal end of the pull-wire composite ring from colliding with the aortic wall during the rocking process of the stent, thereby causing damage.
  • Aorta severe cases may cause aortic dissection in the user, threatening the user's life. Therefore, the positioning member can be pulled toward the outside of the heart valve stent through the pulling wire.
  • the distal end of the heart valve stent also includes a latching end 16 and a reinforcing mesh 15, and a hollow structure 17 exists between the latching end 16 and the reinforcing mesh 15.
  • the number of rhombus-shaped squares at the locking end 16 is 18, which effectively increases the compressibility of the heart valve stent, and the width of the rods constituting the rhombus-shaped squares is gradual (thin in the middle and wide at both ends), so that Optimize the fatigue resistance of the bracket.
  • the heart valve stent described in this article only includes 18 diamond-shaped squares
  • the heart valve stent only needs a reinforcing mesh 15 between adjacent fastening arcs to connect the clamping ends, which can form a large number of hollow parts, effectively It reduces the weight of the heart valve stent and is easy to compress, and the width of the rods forming a diamond-shaped square is gradually changed (thin in the middle and wide at both ends) to optimize the fatigue resistance of the stent.
  • the presence of the reinforcing mesh 15 can not only increase the structural strength of the middle part of the stent, but also isolate the autogenous valve leaflets to prevent infringement of the artificial valve leaflets.
  • the heart valve stent may include three structurally identical support members, positioning members, fasteners and connecting members. Adjacent connecting parts are connected through supporting parts, positioning parts and fasteners. At the same time, adjacent support parts, positioning parts and fasteners are connected through connecting parts.
  • the heart valve stent When the heart valve stent is in an extended state, it is essentially cylindrical.
  • the artificial heart valve leaflets can be sandwiched between the support member and the positioning member, as shown in Figures 6 and 7.
  • Embodiment 2 The difference between Embodiment 2 and Embodiment 1 is that the support member includes a support member pull wire loop 114 adapted to penetrate the pull wire.
  • the support member wire ring 114 is fixedly connected to the support member and is located on a side of the support member facing the distal end of the heart valve stent.
  • the description of the characteristics of the heart valve stent in Embodiment 1 with reference to the drawings is also applicable to this embodiment and will not be described again.
  • the position of the support member wire ring is aligned with the position of the wire composite ring.
  • the support member cable ring is tilted outward relative to the support member.
  • the support member cable ring is tilted outward at an angle ⁇ of 100°-160° relative to the support member. , so that the support wire ring is tilted outward relative to the axis of the stent.
  • the heart valve stent of this embodiment can reduce the difficulty of clamping the native valve leaflets between the positioning member and the support member in Embodiment 1.
  • a pull wire ring is added to the distal end of the support member, and a pull wire 3 is used to control the positioning member.
  • the pull wire 3 controls the support member so that the positioning member opens outward and the support member bends inward, thereby forming a larger gap between the two, making it easier for the native leaflets to be sandwiched between the positioning member and the support member.
  • Embodiment 3 provides an anti-reflux cardiac stent.
  • a connection structure is provided between the support member and the positioning member.
  • the anti-reflux cardiac stent of this embodiment will be described in detail below with reference to Figures 10-13.
  • FIG. 10 shows a perspective view of the anti-reflux cardiac stent 1 according to this embodiment when it is in an extended state
  • FIG. 11 shows an expanded view of the anti-reflux cardiac stent 1 according to this embodiment.
  • the anti-reflux cardiac stent 1 may include a distal end of the anti-reflux cardiac stent close to the apex when the anti-reflux cardiac stent is in an extended state and a distal end of the anti-reflux cardiac stent.
  • the proximal end of the anti-reflux cardiac stent away from the cardiac apex when the cardiac stent is in the extended state.
  • the proximal end of the anti-reflux cardiac stent may include a connector 14 and a positioning member 12 and a fastener 13 disposed between adjacent connectors. The fastener 13 can be used to fix the leaflets of the artificial heart valve.
  • the support member 11 may include a first support arm 111, a second support arm 112, and a support distal end 113 connecting the first support arm 111 and the second support arm 112.
  • the first support arm 111 is fixedly connected to the first connecting piece
  • the second supporting arm 112 is fixedly connected to the second connecting piece
  • the first connecting piece is adjacent to the second connecting piece.
  • the positioning member 12 may include a first positioning arm 121, a second positioning arm 122, and a positioning member distal end 123 connecting the first positioning arm and the second positioning arm.
  • the first positioning arm 121 is fixedly connected to the first connecting piece
  • the second positioning arm 122 is fixedly connected to the second connecting piece, and the first connecting piece is adjacent to the second connecting piece.
  • the fastener 13 includes a first fastening arc 131, a second fastening arc 132, and a fastener distal end 133 connecting the first fastening arc and the second fastening arc.
  • the first fastening arc is fixedly connected to the first connecting piece
  • the second fastening arc is fixedly connected to the second connecting piece
  • the first connecting piece is adjacent to the second connecting piece.
  • the positioning member 12 is closer to the distal end of the anti-reflux heart stent than the support member 11
  • the fastener 13 is closer to the distal end of the anti-reflux heart stent than the positioning member 12 .
  • the distal end 113 of the support member and the distal end 123 of the positioning member are rods protruding toward the distal end of the anti-reflux cardiac stent.
  • the positioning member 12 is disposed on one side of the native heart valve leaflet, and the fastener 13 is disposed on the other side of the native heart valve leaflet.
  • the anti-reflux cardiac stent described herein also includes a support member 11.
  • the support member 11 enables the anti-reflux cardiac stent to self-expand more smoothly and increases the diameter during self-expansion. Xiang Li.
  • the positioning member 12 is provided with a cable composite ring 124 , and a connecting mechanism 18 is provided between the cable composite ring 124 and the support member 11 .
  • the distal end 113 of the support member and the pull wire composite ring 124 are connected together through the connection mechanism 18 . If the stiffness of the connecting mechanism, supporting parts and positioning parts is strong enough, the three can be considered to be a whole.
  • the beneficial effects of providing the connecting mechanism 18 are as follows.
  • the connecting mechanism, the supporting member and the positioning member are integrated into a clamping assembly. First of all, because after the clamping component clamps the valve, the stent is always washed by blood, and people are also moving, so the stent is not completely static relative to the valve, but a relatively dynamic process. Therefore, the stress on the clamping component is constantly changing, and it is in a state of constant deformation.
  • the clamping component Even if the movement range is relatively small, the clamping component is prone to fatigue fracture relative to the connection position. There are two connection points, and the cross-sectional area of each connection is small, so the internal stress generated during deformation is small, which increases the fatigue life.
  • the design of the connecting mechanism of the clamping component is mainly to prevent the support and positioning parts from moving separately, resulting in inconsistent clamping forces. For example, if the supporting part is tightly clamped and the positioning part is loose, the setting of the positioning part will be lost. Clamping effect. On the contrary, if the positioning piece is clamped tightly and the supporting piece is loose, the supporting piece will lose its clamping effect. Therefore, the two are connected together through the connecting mechanism so that they can move together.
  • the distance between the far ends of the two is always changing, and If the two are connected through a connecting mechanism, the distance between the two distal ends will no longer change, so the opening angle of the clamping component is limited, or the force required to open the clamping component is increased. Because of this The two not only need to overcome the force when opening, but also need more force to achieve the deformation of the two so that the distance between the distal ends of the two remains unchanged, thus enhancing the performance of the clamping component when clamping the valve. Strong and not easy to loosen.
  • the connecting mechanism 18 may be a connecting rod. In another embodiment, the connecting mechanism 18 may also be a folded line structure. In a specific implementation, the pull wire composite ring 124 is fixedly connected to the positioning member 12 and is located on the side of the positioning member 12 facing the proximal end of the anti-reflux cardiac stent.
  • the pull cord composite ring includes a first through hole 1241 and a second through hole 1242, the first through hole is used to install a mark, and the second through hole is suitable for penetrating the pull cord, And the second through hole is closer to the proximal end of the anti-reflux cardiac stent than the first through hole.
  • the diameter of the first through hole is larger than the diameter of the second through hole.
  • the pull-wire composite ring structure has two through holes.
  • the large hole is for placing marker points to facilitate accurate positioning of implantation and ensure that the positioning part touches the sinus bottom.
  • the small hole is convenient for penetrating the pull-wire.
  • the positioning part is controlled by the pull-wire.
  • the open angle makes it easier to capture the leaflets and reduce the difficulty of operation.
  • the wire composite ring is provided at the distal end of the positioning member and is inclined inward relative to the axis of the stent. Therefore, the positioning member can be pulled toward the outside of the anti-reflux cardiac stent through the pulling wire.
  • connection mechanism between the cable composite ring and the support member enables synchronous control of the opening and closing of the positioning member and the support member, thereby increasing the radial maneuverability of the anti-reflux cardiac stent.
  • the setting of the connecting mechanism also increases the contact area between the artificial heart valve leaflets and the artificial anti-reflux heart stent. As mentioned above, this arrangement can increase the fatigue resistance of artificial anti-reflux cardiac stents.
  • the first support arm and the second support arm are linear.
  • the first positioning arm and the second positioning arm are linear.
  • the first positioning arm and the second positioning arm are linear.
  • the first positioning arm and the second positioning arm are designed to be linear to facilitate compression. When fully compressed, they occupy the smallest space, that is, the adjacent first support arm and the second support arm will be fully close together when compressed.
  • the linear structure can ensure that the two will not interfere during compression. Therefore, the purpose of the first positioning arm and the second positioning arm being linear is also to fully close together without interference during compression.
  • this bracket is cut from a steel pipe.
  • the linear design also facilitates processing, shortens the processing path, and reduces processing costs.
  • the distal end of the positioning member has a parabolic structure, which reduces the contact stress between the positioning member and the sinus bottom and prevents the annulus from rupturing.
  • the support member when the anti-reflux cardiac stent is in an extended state, the support member has a first opening angle, the positioning member has a second opening angle, and the second opening angle is 4°-14°, and the first opening angle is smaller than the second opening angle.
  • the positioning member 12 and the fastener 13 create a certain opening angle, which facilitates the positioning member 12 to capture the valve leaflets and reduces the difficulty of the operation.
  • the positioning member 12 can be used to prevent the valve from shifting in the ventricular direction, and promote the distal end of the artificial valve leaflet to align with the native valve leaflet, so as to restore the function of the native valve to the greatest extent, while maintaining the artificial valve in the position of the original native valve.
  • the artificial valve can replace the native valve very well, reducing the impact on blood flow and reducing the occurrence of thrombus, and the setting of the second opening angle of 4°-14° can make the positioning member 12 and the fastener 13 It can clamp the native valve to prevent the native valve from moving freely.
  • the native valve leaflets and the stent are closely attached, reducing paravalvular leakage.
  • the distal end of the positioning member is closest to the distal end of the anti-reflux cardiac stent and the farthest distal end of the anti-reflux cardiac stent (i.e., the locking end 16 described below)
  • the vertical distance is 4mm-8mm, preferably 6mm.
  • the distal end of the latching end is outwardly expanded relative to the proximal end of the latching end, and the angle at which the distal end of the latching end is outwardly expanded relative to the proximal end of the latching end is 6°-14°.
  • the reason for the need for external expansion is to prevent the lightweight heart valve stent from displacing toward the aorta and acting as an anchor. At the same time, the reason for not creating an excessively large angle is to prevent contact with the His bundle, thereby affecting the normal beating of the heart and endangering life.
  • the width of the fastener 13 is wider than the width of the support member 11 and the positioning member 12 to provide strong support.
  • the connecting member 14 may include a connecting block 141 , a connecting web 142 and a connecting frame 143 .
  • One end of the connecting block 141 forms the proximal end of the anti-reflux cardiac stent, and the other end is connected to the connecting frame 143 through the connecting web 142.
  • the connecting block 141 is for communicating with a transporter that delivers the anti-reflux cardiac stent. Make a connection.
  • connection frame 143 may sequentially include a support connection part, a positioning part connection part, and a fastener. Connection part.
  • the support connection portion may be symmetrical, with one side connected to the first support arm of the first support member and one side connected to the second support arm of the adjacent second support member.
  • the upper edge of the connection point between the support arm and the connecting frame is a smooth arc, and the angle of the arc is 100°-160°.
  • the lower edge of the connection between the support arm and the connecting frame is also a smooth arc, and the angle of the arc is an acute angle.
  • the support arm of the support member includes point X.
  • the first support arm or the second support arm is bent at point X.
  • the deformation point is away from the connection frame, reducing stress concentration. Because both the support member and the positioning member are connected to the connection frame 143, and the space of the connection frame 143 is limited, if the support connection part and the positioning part connection part in the connection frame are very close to each other.
  • the deformation position of the support member relative to the connection frame and the deformation position of the positioning member relative to the connection frame are both at the connection, and the support member and the positioning member are located on both sides of the valve respectively, so if the deformation positions of the two relative to the connection frame are too If the deformation area is too close, it is easy to produce a large shear force on the native valve close to the connecting frame, thereby damaging the valve. Moreover, if the deformation zone is too close, stress concentration may easily occur, causing the connection between the support/positioning member and the connecting frame to break.
  • the deformation position of the support member relative to the connecting frame is shifted to the X point away from the connecting frame, which solves the problem of easily generating large shear force on the native valve close to the connecting frame.
  • the position of each deformation zone becomes further away, which also prevents the problem of excessive stress concentration.
  • the width of the connecting web is smaller than the width of the connecting block and smaller than the width of the connecting portion of the support.
  • the connection frame includes a hollow elongated suture hole 144 .
  • One end of the elongated suture hole 144 may be provided at the support connection part, and the other end may be provided at the positioning part connection part or the fastener connection part.
  • the elongated suture hole 144 allows the proximal edge of the artificial valve leaflet to be sutured directly through the suture hole without adding a suture gasket, and the edge of the artificial valve leaflet is sutured to the fastening arc. This suturing method is relatively traditional.
  • gaskets and stent extrusion to fix the leaflets first reduces the number of external parts of the stent, and the absence of gaskets is also conducive to further compression of the stent. If there are gaskets, it will not only affect the compression of the stent, but also Even sometimes the prosthetic valve leaflets are damaged when the stent is compressed by a smaller stent.
  • the distal end of the anti-reflux cardiac stent also includes a latching end 16 and a reinforcing mesh 15. There is a hollow structure 17 between the latching end 16 and the reinforcing mesh 15.
  • the number of diamond-shaped squares on the locking end 16 is 18, which effectively increases the compressibility of the anti-reflux cardiac stent, and the width of the rods that constitute the diamond-shaped squares is gradual (thin in the middle and wide at both ends) , to optimize the fatigue resistance of the bracket.
  • the anti-reflux cardiac stent described in this article only includes 18 diamond-shaped squares
  • the anti-reflux cardiac stent only needs a reinforcing mesh 15 between adjacent fastening arcs to connect the latching ends, which can form a large number of The hollow part effectively reduces the weight of the anti-reflux cardiac stent and facilitates compression.
  • the width of the rods forming a diamond-shaped square is gradually changed (thin in the middle and wide at both ends) to optimize the anti-fatigue performance of the stent.
  • the presence of the reinforcing mesh 15 can not only increase the structural strength of the middle part of the stent, but also isolate the native valve leaflets to prevent infringement of the artificial valve leaflets.
  • the anti-reflux cardiac stent may include three structurally identical support members, positioning members, fasteners and connecting members. Adjacent connecting parts are connected through supporting parts, positioning parts and fasteners. At the same time, adjacent support parts, positioning parts and fasteners are connected through connecting parts.
  • the anti-reflux cardiac stent When the anti-reflux cardiac stent is in an extended state, it is essentially cylindrical.
  • the artificial heart valve leaflets can be sandwiched between the support member and the positioning member, as shown in Figure 15.
  • Embodiment 4 The difference between Embodiment 4 and Embodiment 3 is that the connecting mechanism 18 is a connecting rod containing rhombus squares.
  • the connection mechanism 18 may include a first link 181 , a second link 182 , and a diamond-shaped square 183 connecting the first link 181 and the second link 182 .
  • One end of the first connecting rod 181 can be fixedly connected to the second through hole of the cable composite ring 124 , and the other end can be fixedly connected to a vertex of the rhombus square 183 .
  • One end of the second link can be fixedly connected to the support member, and the other end can be fixedly connected to the other vertex of the rhombus square 183 .
  • the longitudinal axes of the first link 181 and the second link 182 may be on the same straight line, and the length of the first link 181 may be smaller than the length of the second link 182 .
  • the diamond-shaped square grid 183 is composed of two grid connecting rods I1831 and two grid connecting rods II1832, in which one end of the two grid connecting rods I1831 is jointly connected to one end of the first connecting rod 181 , one end of the two lattice connecting rods II 1832 is jointly connected to one end of the second connecting rod 182, and the other end (free end) of the lattice connecting rod I 1831 is fixedly connected to the other end (free end) of the lattice connecting rod II 1832.
  • the other end (free end) of the lattice connecting rod I 1831 is fixedly connected to the other end (free end) of the lattice connecting rod II 1832 through a curved connection part 184, wherein the width L2 of the curved connection part 184 is smaller than the width L2 of the lattice connecting rod I 1831.
  • the width L1 of the connecting rod II 1832 makes it easier for the grid connecting rod I 1831 and the grid connecting rod II 1832 to move with each other. Compared with the method of directly connecting the distal end 113 of the support member and the cable composite ring 124 through a connecting rod, the alignment of the positioning member is reduced. Effects of distal flexibility.
  • the stent When, for example, a person jumps or the stent is impacted by blood, the stent will be driven to move up and down. At this time, the distal end of the positioning piece will slam against the bottom of the aortic valve annulus. Because the positioning piece is connected with a connecting mechanism through a composite pull wire ring, the positioning piece will be damaged. The distal height of the aortic valve annulus is relatively strong, and the bottom of the aortic valve annulus will be damaged to a certain extent under multiple collisions.
  • the connecting mechanism has a certain degree of flexibility, which can greatly reduce the stiffness of the distal end of the positioning piece and reduce the distance of the positioning piece. End-to-end injury to the base of the aortic annulus.
  • the connecting mechanism may include a zigzag structure.
  • the folded line structure may be a connecting rod containing half of a rhombus square, that is, the folded line structure includes: a first connecting rod 181, and one end of the first connecting rod 181 is connected to a lattice connecting rod I 1831, The other end of the grid link I 1831 is fixedly connected to the grid link II 1832, and the other end of the grid link II 1832 is fixedly connected to one end of the second link 182.
  • the grid link I and the grid link II The curved connection part 184 is fixedly connected, and the width of the curved connection part 184 is smaller than the width of the lattice connecting rod I 1831 and the lattice connecting rod II 1832. This makes it easier for the lattice connecting rod I 1831 and the lattice connecting rod II 1832 to move with each other, compared with directly connecting through the connecting rods.
  • the manner in which the distal end 113 of the support member and the pull wire composite ring 124 reduce the impact on the flexibility of the distal end of the positioning member. When, for example, a person jumps or the stent is impacted by blood, the stent will be driven to move up and down.
  • the distal end of the positioning piece will slam against the bottom of the aortic valve annulus. Because the positioning piece is connected with a connecting mechanism through a composite pull wire ring, the positioning piece will be damaged.
  • the distal height of the aortic valve annulus is relatively strong, and the bottom of the aortic valve annulus will be damaged to a certain extent under multiple collisions.
  • the connecting mechanism has a certain degree of flexibility, which can greatly reduce the stiffness of the distal end of the positioning piece and reduce the distance of the positioning piece. End-to-end injury to the base of the aortic annulus.
  • the folding line structure can also adopt an S-shaped structural design as shown in Figure 14C, that is, the first connecting rod 181 is fixedly connected to the second connecting rod 182 through three connecting rods, but the folding line structure does not Limited to this, the first connecting rod 181 can be fixedly connected to the second connecting rod 182 through several connecting rods. Preferably, several connecting rods between the first connecting rod 181 and the second connecting rod 182 can be connected through curved connecting parts. 184 to connect.
  • the lengths of the first link 181 and the second link 182 can be zero, that is, the components between the first link 181 and the second link 182 can be directly fixed. Connected to the distal end 113 of the support member and the pull wire composite ring 124.
  • Embodiment 5 The difference between Embodiment 5 and Embodiment 1 lies in the structure of the reinforcing mesh. Since the angle between adjacent fastening arcs is small, when the anti-reflux heart valve stent self-expands, it is easy to self-expand not in place. Therefore, a reinforcing net with large radial support force is added to achieve its expansion to the predetermined position. size.
  • the reinforcing mesh may include a first self-expanding arc 151 and a second self-expanding arc 152 arranged sequentially in a direction from the distal end of the heart valve stent to the proximal end of the heart valve stent. and the third self-expanding arc 153.
  • One end of the first self-expanding arc is fixedly connected to the first fastening arc of the fastener, and the other end is fixedly connected to the second fastening arc of the adjacent fastener, and protrudes toward the distal end of the heart valve stent.
  • Two ends of the second self-expanding arc are respectively fixedly connected to the first self-expanding arc and protrude toward the proximal end of the heart valve stent.
  • One end of the third self-expanding arc is fixedly connected to the first fastening arc of the fastener, and the other end is fixedly connected to the second fastening arc of the adjacent fastener, and protrudes toward the distal end of the heart valve stent.
  • the width of the first self-expanding arc is greater than the width of the second self-expanding arc and the third self-expanding arc.
  • the size of the first self-expanding arc is larger than that of the second self-expanding arc and the third self-expanding arc, and its span is also the largest. Therefore, the first self-expanding arc needs to provide greater radial support force to ensure its stable support. performance, so the width of the first self-expanding arc is wider.
  • the reinforced network configuration composed of the first self-expanding arc, the second self-expanding arc, and the third self-expanding arc, it can not only still prevent the native valve from invading the artificial valve, but also solve the problem of This solves the problem of weak radial support between adjacent fastening arcs and insufficient self-expansion.
  • the first self-expanding arc 151 is composed of two self-expanding arms I 1511.
  • the proximal ends of the two self-expanding arms I are fixedly connected to the middle positions of the two fastening arcs.
  • the two self-expanding arms I The distal ends of I are connected to each other, and the connection point and the clamping end are also fixedly connected.
  • the second self-expanding arc 152 is composed of two self-expanding arms II 1521.
  • the distal ends of the two self-expanding arms II are fixedly connected to the middle positions of the two self-expanding arms I respectively.
  • the proximal end of arm II is connected.
  • the length of the self-expanding arm II is not greater than half the length of the self-expanding arm I.
  • the length of the self-expanding arm II is half the length of the self-expanding arm I;
  • the third self-expanding arc 153 is composed of two self-expanding arms III 1531.
  • the proximal ends of the two self-expanding arms III are respectively fixedly connected to the 1/4 of the proximal ends of the two fastening arcs.
  • the distal ends of the two self-expanding arms II are connected.
  • the length of the self-expanding arm III is not greater than half the length of the self-expanding arm II.
  • the length of the self-expanding arm III is half of the length of the self-expanding arm II;
  • the above design can realize reasonable utilization of space, and its structure can be realized by using only one pipe.
  • the first fastening arc of the fastener and the second fastening arc of the adjacent fastener form a first rounded corner 154;
  • the second self-expanding arc has a There are two rounded corners 155 and the third self-expansion arc has a third rounded corner 156 .
  • the third fillet 156 is not larger than the first fillet 154 formed by its corresponding adjacent fastening arc, because the closer to the connection of the proximal end of the fastener, the smaller the space, that is, the greater the amount of material, that is, there is no material.
  • the second fillet 155 is larger than the first fillet 154.
  • the second rounded corner 155 is a rounded corner formed by the connection of the two self-expanding arms II 1521 that is larger than the corresponding second self-expanding arc 152 .
  • the first self-expansion arc 151, the second self-expansion arc 152 and the third self-expansion arc 153 are provided, but this does not mean that the reinforcing mesh is only provided with three self-expansion arcs.
  • a new self-expanding arc is set inside the arc 152, and the fillet formed by the connection of the two self-expanding arms of the new self-expanding arc is not larger than the fillet formed by the connection of the two self-expanding arms II 1521 of the corresponding second self-expanding arc 152.
  • the rounded corners, and the width of the self-expanding arm of the new self-expanding arc is smaller than the self-expanding arm of the connected self-expanding arc, so as to reduce the space occupation rate.
  • the new self-expanding arc can also be set with a new self-expanding arc. , in the same way, a new self-expanding arc can also be set inside the third self-expanding arc, but the total number of self-expanding arcs in the reinforced mesh shall not exceed 5, so as not to affect the compression performance of the anti-reflux stent.
  • This embodiment provides an anti-reflux heart valve stent without a support member.
  • Example 6 The difference between Example 6 and Example 1 is that it does not contain a support member.
  • the anti-reflux heart valve stent of this embodiment does not include a support member.
  • the proximal end of the positioning member is connected to the proximal end of the connecting frame, or the proximal end of the positioning member is connected to the distal end of the connecting web, and the connection between the positioning member and the connecting web forms the connection frame. near end. Because the support ribs are eliminated in the above structural design, the proximal end of the positioning member can be set closer to the proximal end of the anti-reflux heart valve stent, thereby increasing the distance from the proximal end to the distal end of the positioning member, that is, increasing the positioning member.
  • the positioning piece Clamps the space of the native valve leaflets, so when facing the native valve leaflets of the larger main (pulmonary) artery, the positioning piece will not be unable to be inserted into the sinus bottom due to the obstruction of the native valve leaflets, and the distal end of the positioning piece can be fully inserted to the sinus bottom, which prevents the distal end of the positioning member from being unable to be inserted into the sinus bottom, causing the anti-reflux heart valve stent to be displaced under the large pressure difference generated during ventricular diastole, causing the distal end of the positioning member to impact the sinus The situation of the bottom of the sinus occurs, causing damage to the sinus bottom.
  • the connecting rod at the clamping end adopts a design that is thin in the middle and thick at both ends, which optimizes the fatigue resistance of the bracket.
  • the middle position is too thin, it will affect the radial support force of the clamping end. Therefore, it is necessary to optimize the fatigue resistance of the clamping end of the bracket on the basis of ensuring the radial support force of the clamping end. Therefore, the minimum width X of the connecting rod at the clamping end should be controlled within the range of 0.53 to 0.93 times the maximum width dimension Y. .
  • This embodiment provides an anti-reflux heart valve stent without a support member.
  • Example 7 The difference between Example 7 and Example 5 is that it does not contain a support member.
  • the anti-reflux heart valve stent of this embodiment does not include a support member.
  • the proximal end of the positioning member is connected to the proximal end of the connecting frame, (or the proximal end of the positioning member is connected to the distal end of the connecting web, and the connection between the positioning member and the connecting web forms a connecting frame (proximal end)
  • the above structural design eliminates the supporting ribs, so the proximal end of the positioning member can be set closer to the proximal end of the anti-reflux heart valve stent, thus increasing the distance from the proximal end to the distal end of the positioning member.
  • the space for the positioning piece to clamp the native valve leaflets is increased. Therefore, when facing the native valve leaflets of the larger main (pulmonary) artery, the positioning piece will not be unable to be inserted into the sinus bottom due to the obstruction of the native valve leaflets.
  • the positioning piece is far away from the sinus bottom. The end can be fully inserted into the sinus bottom, preventing the distal end of the positioning member from being unable to be inserted into the sinus bottom and causing the anti-reflux heart valve stent to be displaced under the large pressure difference generated during ventricular diastole, making the positioning member far away
  • the tip may impact the sinus floor, causing damage to the sinus floor.
  • Embodiment 8 lies in the structure of the wire-stayed composite ring.
  • the distal end of the traditional positioning member is provided with a marker "marker” (the marker is radiopaque).
  • the marker is radiopaque.
  • the setting of the “marker” facilitates the positioning and implantation of the stent to a certain extent, there are still problems with the "marker” Risk of shedding. If the “marker” falls off and enters other organs along with the blood flow, this will seriously affect the safety of the user.
  • the surface of the cable composite ring is provided with an X-ray opaque marking layer or a high-density metal plating is added to the surface of the cable composite ring, so that the cable composite ring can be seen more clearly under X-rays.
  • the cable composite ring can be made into a special shape, such as gourd type, triangular star shape, prismatic shape, cat claw shape, etc., so that the operator can quickly identify the cable composite ring. , replacing the marker "marker”.
  • Embodiment 9 The difference between Embodiment 9 and Embodiment 7 lies in the structure of the reinforcing mesh.
  • the reinforcing mesh 15 is composed of a curved self-expanding arc 157, a connecting grid 158 and a third self-expanding arc 153.
  • the curved self-expanding arc 157 is composed of four sections, namely curved arm I1571, curved arm II1572, curved arm III1573, and curved arm IV1574.
  • crank arm I and the crank arm IV are respectively connected to the fastening arc at 0.25 to 0.33 near the distal end (the fastener is composed of two fastening arcs), and the distal ends of the crank arm I and the crank arm II are fixedly connected, and the connection
  • the distal ends of curved arms III and IV are fixedly connected, and the connection is connected with the clipping end.
  • the proximal ends of curved arms II and III are fixedly connected, and the connections are fixedly connected.
  • the coupling lattice includes two coupling arms 1581.
  • the distal ends of the two connecting arms 1581 are connected to each other, and their joints are fixedly connected to the self-expanding arc.
  • the lengths of the curved arm I, the curved arm II, the curved arm III, and the curved arm IV of the curved self-expanding arc are equal.
  • the proximal ends of the connecting arms are connected to each other, and their connections are fixedly connected to the third self-expanding arc.
  • the third self-expanding arc includes two self-expanding arms III, in which the proximal ends of the self-expanding arms III are connected to the fastening arc, and are connected The point is close to the Q length of the proximal end of the fastening arc.
  • the Q value is less than or equal to 1/4 of the fastening arc length.
  • the length Z of the self-expanding arm III is not less than 0.8Q, so that the connection grid will support the third self-expanding arc and
  • the curved self-expanding arc promotes the self-expansion of the anti-reflux stent to a certain extent and will not block the pulling of the third self-expanding arc and the curved self-expanding arc, thereby affecting the expansion of the anti-reflux stent.
  • the axial height H of the connecting grid is the third self-expanding arm.
  • the distance between the expansion arc and the curved self-expanding arc will increase with the expansion of the anti-reflux stent, so that the purpose of supporting the third self-expanding arc and the curved self-expanding arc cannot be achieved, so the distance from the expansion arm III
  • the length Z is not less than 0.8Q, and the interval from 0.6 to 0.8 is mainly used as a coefficient buffer.
  • Embodiment 10 The difference between Embodiment 10 and Embodiment 9 lies in the structure of the reinforcing mesh.
  • coupling holes 1582 are provided on the coupling arms 1581 of the coupling grid 158, and one or more coupling holes can be provided on each coupling arm.
  • one coupling hole is provided, In the middle of the coupling arm.
  • the coupling holes are evenly distributed on the coupling arms.
  • the sutures used here are elastic. In order to achieve a certain degree of flexibility in the connection grid, there can still be a certain degree of flexibility.
  • connection grid in the circumferential length L direction, but at the same time limits the increase of the connection grid in the circumferential length L, so the axial height H of the connection grid will increase, so the connection grid will provide a greater force to support the third
  • the three self-expanding arcs and the curved self-expanding arc further promote the opening of the third self-expanding arc and the curved self-expanding arc, allowing the anti-reflux stent to self-expand to achieve the desired effect.
  • the connecting arms In order to realize that the two connecting arms of the connecting lattice can bend to both sides respectively when expanding, the connecting arms have an arc structure.
  • the concave surface of the arc structure faces inward and the convex surface of the arc structure faces outside.
  • This embodiment provides an anti-reflux heart valve stent, which further includes a mesh-like coating fixed on the inside of the anti-reflux heart valve stent.
  • the mesh-like covering 3 is fixed to the anti-reflux heart valve stent 1 by sewing with each component of the anti-reflux heart valve stent 1.
  • the artificial valve leaflet 2 can be sutured to the mesh covering 3 .
  • the traditional method of sewing artificial valve leaflets to the anti-reflux heart valve stent is to sew the artificial valve leaflets and the anti-reflux heart valve stent, such as fastening arcs, but the surface of the fastening arcs is artificially smooth, so the artificial valve cannot be fixed. Reliable, by setting the fastening arc into a curved shape, or adding fixing holes. In order to ensure the strength of the fastening arc, the width of the fastening arc is increased, which increases the volume of the anti-reflux heart valve stent, causing anti-reflux It is difficult to compress the heart valve stent, and the expected compression resistance of the heart valve stent against reflux cannot be achieved.
  • the anti-reflux stent Since the diameter of the self-expanding anti-reflux stent that needs to be compressed is small, the material thickness and width are greatly limited. Therefore, the anti-reflux stent is expected to be compressed without excessive external force interference, such as The force from the coating.
  • the coating used in traditional anti-reflux stents is mostly made of PET woven material, and the woven patterns are mostly horizontal and vertical, that is, the horizontal and vertical lines of the PET woven fabric are 90° perpendicular to each other.
  • the PET woven fabric When sutured, the PET woven fabric
  • the longitudinal line and the axis of the anti-reflux stent are parallel to each other, and the transverse line is parallel to the circumferential direction of the anti-reflux stent. Therefore, during the compression process of the anti-reflux stent, the coating and the stent are fixed.
  • the length of the longitudinal line of the PET woven fabric is determined, and the anti-reflux stent will grow during the compression process, especially the length of the upper and lower connecting points of the diamond-shaped connecting rods at the clamping end. increase, but the vertical line (hereinafter referred to as the vertical line) that fixes the PET coating will not grow, so the vertical line at this time will block the diamond-shaped structure at the clamping end from compressing the side length, so at this time the diamond-shaped structure is affected by external forces.
  • the compression continues, but the longitudinal line has always blocked the compression of the diamond structure. Therefore, under the action of the two forces of compression and compression resistance, the diamond structure at the clamping end is easily deformed and damaged.
  • the compression-blocking force generated by the traditional horizontal and vertical PET coating not only acts on the diamond-shaped structure at the clamping end, but also acts on the diamond-shaped structure and fasteners of the reinforcing mesh, blocking the compression of both. , thereby affecting the compression of the entire stent, and even the force generated to prevent the anti-reflux stent may cause damage to the entire stent during the compression process.
  • the anti-reflux heart valve stent is covered with a mesh woven from PET material, and the covering 3 is sutured with each component of the anti-reflux heart valve stent, Because the anti-reflux heart valve stent is intricate, the covering can be firmly fixed on the inside of the anti-reflux heart valve stent. Since the size of the anti-reflux heart valve stent will change, if the artificial valve leaflets are sutured with the anti-reflux heart valve stent, the size and shape of the artificial valve leaflets will also need to change as the anti-reflux heart valve stent changes. It reduces the versatility of the artificial valve leaflets and increases the cost. Moreover, because it is necessary to ensure that the performance parameters of the artificial valve leaflets meet the requirements, changing the size and shape of the valve requires redesigning to meet the standards, so the artificial valve leaflets are not versatile. It will also increase the design intensity of designers.
  • the combination of artificial valve leaflets and coating is used, compared with the traditional method of using integral artificial valve leaflets to cover the entire anti-reflux heart valve stent, which increases the compressibility of the anti-reflux heart valve stent because the PET used
  • the thickness of the mesh woven with the material is smaller than that of the artificial valve leaflet, which reduces the occupation of the internal space of the anti-reflux heart valve stent, thereby increasing the compressibility of the anti-reflux heart valve stent.
  • Prosthetic leaflets may comprise one or more synthetic materials, engineered biological tissue, biologic leaflet tissue, pericardial tissue, cross-linked pericardial tissue, aortic root tissue, chemically or biologically processed/treated tissue, or combinations thereof .
  • the pericardial tissue is selected from the group consisting of, but not limited to, bovine, equine, porcine, ovine, and human tissue, or combinations thereof.
  • the distal end of the artificial valve leaflet is no longer fixedly connected to the fastening arch but spans the fastening arch and is fixedly connected to the covering of the fastening arch and the anti-reflux heart valve stent at the clamping end.
  • the coating can be penetrated arbitrarily using sutures, the artificial valve leaflets can be firmly connected to the coating, and the density of the sutures can be increased to improve the sealing performance between the artificial valve leaflets and the coating.
  • it prevents blood from leaking through the joint position of the artificial valve leaflet and the covering membrane, and by suturing the covering membrane and the artificial valve leaflet, the operator does not need to frequently bypass the suture line around the fastening arch or fixing hole, which reduces the operator's time. reduce labor intensity and improve efficiency.
  • the artificial valve leaflets are sutured with the stent, then as the stent changes, the artificial valve leaflets will inevitably move with the stent, and the movement of the stent is rigid relative to the coating, that is, the movement state is fixed , so the artificial valve leaflets and the stent are sutured.
  • the stent will tear the artificial valve leaflets, and the artificial valve leaflets and the covering film are sutured together.
  • the covering film is relatively soft and allows a certain degree of displacement. Therefore, there will be no strong tearing force on the artificial valve leaflets, ensuring the safety of the artificial valve leaflets.
  • the PET woven fabric in order for the coating to adapt to the anti-reflux stent, is designed to improve the fixation method of the artificial valve leaflets and the connection frame.
  • PET woven fabric can usually be woven from vertical threads (warp threads) and horizontal threads (weft threads).
  • the angle between the longitudinal lines and the horizontal lines of the PET woven fabric is set to 60° to 90°.
  • the reason for setting this angle is that the angle formed by any two directly connected connecting rods (the supplementary angle of an acute or obtuse angle) in the diamond-shaped structure of the clamping end and its reinforcing net is in the range of 60° to 90°, so that The angle formed by the longitudinal and transverse lines of the PET woven fabric is consistent with the angle formed by the connected connecting rods in the rhombus structure (the supplementary angle of the acute or obtuse angle).
  • the angle formed by the connected connecting rods in the rhombus structure is 90°
  • the angle between the longitudinal and transverse lines of the PET woven fabric is also 90°
  • the connected connecting rods in the rhombus structure The angle formed is generally not less than 60°. If the angle is too small, it will affect its circumferential support force.
  • the PET woven cloth fixedly connected to the connecting rod of the diamond-shaped structure will move with the connecting rod.
  • the upper and lower connection points of the connecting rod of the diamond-shaped structure are also connected by several vertical lines and horizontal lines.
  • the connection is made up of lines rather than a vertical line (horizontal line).
  • the ears 403 of the artificial valve leaflets pass through the connecting frame 143, and bypass the side posts of the connecting frame so that the tail ends of the ears return to the anti-reflux valve.
  • the inside of the stent is fitted with the artificial valve leaflet at the connection between the main body of the artificial valve leaflet and the ear, and the wavy suture 5 is passed through the artificial valve leaflet located in the same connection frame, and the tail end of the ear part of the artificial valve leaflet is tightly connected
  • the artificial valve leaflets are fixed and the adjacent artificial valve leaflets are close to the stent.
  • the wavy fold line means that the suture line is sutured along the path of the wavy line. Its main purpose is to increase the contact area between the tail end of the ear of the artificial valve leaflet and the connection between the ear of the artificial valve leaflet, thereby increasing stability. , and also increases the contact area at the ear connection of adjacent artificial valve leaflets, preventing blood reflux on the side of the artificial valve leaflets close to the stent.
  • the artificial valve leaflets have a certain elasticity, and only wavy sutures are used to fix the artificial valve leaflets, under the elasticity of the artificial valve leaflets, the artificial valve leaflets will be The leaflets slide relative to the side columns of the connecting frame, thus affecting the effect of the artificial valve leaflets. Therefore, it is necessary to increase the wrapping force of the artificial valve leaflets on the side columns, so the surrounding suture line 6 is added.
  • each adjacent surrounding suture line is independent, and the surrounding suture line circles the connecting frame so that the ears of the artificial valve leaflets closely fit the side columns.
  • the adjacent surrounding suture lines pass through the valleys on both sides of the wavy suture line in turn, effectively preventing the surrounding suture line from only tearing the artificial valve leaflets on one side of the wavy suture line, affecting the performance and safety of the artificial valve leaflets. service life.
  • the surrounding suture line is formed from a clockwise spirally wound surrounding suture line and another counterclockwise spirally wound surrounding suture line from top to bottom.
  • each spiral wound The surrounding suture line adopts an integrated spiral surrounding suture line, which is simple to operate and firmly fixed. There are no excessive suture ends, which increases the stability of use.
  • the one here does not refer to a suture line, but can also be a
  • the bundle suture is a number of sutures.
  • the two sutures pass through the valleys on both sides of the wavy suture in sequence, preventing the connection frame from producing asymmetrical forces due to suturing, thus causing tearing force on the artificial valve leaflets and affecting the force of the artificial valve.
  • the ear portion of the artificial valve leaflet is inclined downward relative to the upper horizontal line of the main body of the artificial valve leaflet.
  • the main reason is that in order to further shorten the length of the reflux stent, the distance between the connecting frame and the connecting frame is The distance between the distal end of the artificial valve leaflet and the distal end of the artificial valve leaflet is shorter than the proximal end of the artificial valve leaflet. Therefore, in order to smoothly place the ear of the artificial valve leaflet into the connection frame, it needs to be tilted downward.
  • the artificial valve leaflet 2 may include an artificial valve leaflet body 404, an ear portion 403, a fastener 401 and an inner concave area 402.
  • the main body of the artificial valve leaflet is set in a general V-shape, but there are concave areas on both sides of the main body of the artificial valve leaflet near the distal end. Its main purpose is to accommodate fasteners. Since the fasteners During the compression process, it will change from a curved shape to a straight shape.
  • the traditional artificial valve leaflets are convex in the concave area (hereinafter referred to as the convex area), which will cause a larger problem when the fasteners are straightened.
  • the resistance force causes excessive extrusion at the suture position of the artificial valve leaflets, especially at the midpoint of the convex area, where the extrusion is the most serious.
  • the concave area of this design is concave, so the distance from the midpoint of the concave area to the fastener is short, that is, the artificial valve leaves use less material and have a larger space to accommodate the material extruded during the extrusion process. , so during the process of straightening the fastener, there will be no excessive compression of the suture position of the valve leaflets.
  • the distal end of the main body of the artificial valve leaflet is provided with an anti-wear edge strip 405, which is combined with the main body of the artificial valve leaflet by suturing, and is firmly fixed, and the anti-wear edge strip is provided Firstly, it increases the tear resistance of the distal end of the main body of the artificial valve leaflet. Secondly, it reduces the damage to the artificial valve leaflet caused by the friction between the distal end of the main body of the artificial valve leaflet and the covering membrane, increases the service life of the artificial valve leaflet, and is anti-wear.
  • the setting of the edge strips is also equivalent to a buffer layer between the artificial valve leaflets and the coating, which effectively buffers the tearing force of the artificial valve leaflets on the coating during the opening and closing process, and increases the service life of the anti-reflux stent.
  • the inner coating of the clamping end is the leak-proof skirt.
  • the distal end of the clamping end is provided with a leak-proof skirt (not shown in the figure), and the outer side of the clamping end is also covered with film, and the distal end of the outer side is covered with film all the way to the fastening arch.
  • the outer coating of the stuck end can be the inner coating everted to the outside, or it can be a single coating, which effectively prevents side leakage of the reflux stent and increases the side leakage prevention performance of the stent.

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Abstract

一种抗反流心脏瓣膜支架(1)，包括在抗反流心脏瓣膜支架(1)处于伸展状态时靠近心尖的抗反流心脏瓣膜支架远端以及在抗反流心脏瓣膜支架(1)处于伸展状态时远离心尖的抗反流心脏瓣膜支架近端，抗反流心脏瓣膜支架(1)构造成能有效地避免原生心脏瓣膜瓣叶侵扰人工心脏瓣膜瓣叶。

Description

抗反流心脏瓣膜支架 技术领域
本发明涉及医疗器械技术领域，具体涉及一种抗反流心脏瓣膜支架。
背景技术
由于经导管进行手术的方式具有创伤小、恢复快等诸多优点，因此越来越多的手术都开始采用经导管进行手术。主动脉瓣置换术也由早期的外科开刀方式改变为经导管进行主动脉瓣的置换。为此，需要提供一种可以适用于经导管进行主动脉瓣置换、便于固定，且固定牢靠的心脏瓣膜支架。
授权公告号为CN102413793B且标题为“用于瓣膜假体在病人心脏中的植入部位的定位和锚定的支架”的中国发明专利披露了一种可扩张支架，其包括多个定位弧和多个保持弧，所述定位弧构成位于原生心瓣膜上的多个囊袋内且位于多个原有心瓣膜小叶的第一侧上，所述多个保持弧被构造为位于与第一侧相对的所述多个原生心瓣膜小叶的第二侧上。所述保持弧被多个弯曲边缘划分成多个臂段，所述臂段互联形成保持弧臂，其在支架未扩展状态时成直线。所述保持弧的各臂具有与被附着于支架的瓣膜假体的小叶匹配的形状。但在该现有技术披露的心脏瓣膜支架中，将原生瓣叶直接夹在定位件与紧固弧之间，存在原生心脏瓣膜瓣叶侵扰人工心脏瓣膜瓣叶的风险。
此外，主动脉瓣的置换通常要借助抗反流心脏支架和输送器来完成，其中需要解决的技术难题之一如何固定原生心脏瓣膜瓣叶。现有技术中通过将原生心脏瓣膜瓣叶夹合在抗反流心脏支架的定位件和紧固件之间，这要求定位件在抗反流心脏支架处于扩展状态时，具有合适的张开角度。但因为定位件通常是一根弯曲的杆，两端分别与抗反流心脏支架的连接块固定连接，膨胀之后大部分处于悬空状态，使得定位件沿径向的扩展角度难以控制。
另外，心脏瓣膜支架是实现心脏瓣膜置换手术的关键器械之一，而心脏瓣膜支架通常由医用不锈钢材料制成，现有技术中的心脏瓣膜支架远端的连接结构密度偏高，增加了心脏瓣膜支架的重量，这一方面使得心脏瓣膜支架更难以操控，另一方面也增加了材料成本。
为此，本领域持续需要开发定位精准、易于操控、轻量化的抗反流心脏瓣膜支架。
发明内容
本申请之目的在于提供一种抗反流心脏瓣膜支架。
为实现上述目的，本发明提供如下所述的技术方案。
在第一方面中，本申请提供一种抗反流心脏瓣膜支架，包括在该抗反流心脏瓣膜支架处于伸展状态时靠近心尖的抗反流心脏瓣膜支架远端以及在该抗反流心脏瓣膜支架处于伸展状态时远离心尖的抗反流心脏瓣膜支架近端，其特征在于，所述抗反流心脏瓣膜支架构造成能有效地避免原生心脏瓣膜瓣叶侵扰人工心脏瓣膜瓣叶。
在第二方面中，本申请提供一种抗反流心脏瓣膜支架，包括在该抗反流心脏瓣膜支架处于伸展状态时靠近心尖的抗反流心脏瓣膜支架远端以及在该抗反流心脏瓣膜支架处于伸展状态时远离心尖的抗反流心脏瓣膜支架近端，其特征在于，所述抗反流心脏瓣膜支架近端包括连接件以及设置在相邻连接件之间的支撑件、定位件和紧固件，所述紧固件用于固定人工心脏瓣膜瓣叶；
其中，所述支撑件包括第一支撑臂、第二支撑臂以及连接所述第一支撑臂和所述第二支撑臂的支撑件远端，所述第一支撑臂固定连接至第一连接件，所述第二支撑臂固定连接至第二连接件，所述第一连接件与所述第二连接件相邻；
其中，所述定位件包括第一定位臂、第二定位臂以及连接所述第一定位臂和所述第二定位臂的定位件远端，所述第一定位臂固定连接至第一连接件，所述第二定位臂固定连接至第二连接件，所述第一连接件与所述第二连接件相邻；
其中，所述紧固件包括第一紧固弧、第二紧固弧以及连接所述第一紧固弧和所述第二紧固弧的紧固件远端，所述第一紧固弧固定连接至第一连接件，所述第二紧固弧固定连接至第二连接件，所述第一连接件与所述第二连接件相邻；
其中，所述定位件比所述支撑件更靠近所述抗反流心脏瓣膜支架远端，所述紧固件比所述定位件更靠近所述抗反流心脏瓣膜支架远端，所述支撑件远端和所述定位件远端为朝向所述抗反流心脏瓣膜支架远端凸起的杆，所述支撑件设置在原生心脏瓣膜瓣叶的一侧，且所述定位件设置在原生心脏瓣膜瓣叶的另一侧。
优选地，当所述抗反流心脏瓣膜支架处于压缩状态时，所述第一支撑臂和所述第二支撑臂为线性的。
优选地，当所述抗反流心脏瓣膜支架处于压缩状态时，所述第一定位臂和所述第二定位臂为线性的。
优选地，所述定位件远端为抛物线结构。
优选地，当所述抗反流心脏瓣膜支架处于伸展状态时，所述支撑件具有第一张开角度，所述定位件具有第二张开角度，所述第二张开角度为4°-14°，且所述第一张开角度小于 所述第二张开角度。
优选地，所述定位件远端最靠近所述抗反流心脏瓣膜支架远端之处与所述抗反流心脏瓣膜支架远端最远处的垂直距离为4mm-8mm，优选地为6mm。
优选地，所述连接件包括连接块、连接腹板以及连接框架，所述连接块的一端形成所述抗反流心脏瓣膜支架近端，另一端通过所述连接腹板与所述连接框架连接，沿着从所述抗反流心脏瓣膜支架近端到所述抗反流心脏瓣膜支架远端的方向，所述连接框架依次包括支撑件连接部分、定位件连接部分以及紧固件连接部分。
优选地，所述连接腹板的宽度小于所述连接块的宽度，且小于所述支撑件连接部分的宽度。
优选地，所述连接框架包括中空的长条形缝合孔。
优选地，所述定位件包括拉线复合环，所述拉线复合环固定连接至所述定位件，且位于所述定位件朝向所述抗反流心脏瓣膜支架近端的一侧，所述拉线复合环包括第一通孔和第二通孔，所述第一通孔用于安装标记，所述第二通孔适于穿入拉线，且所述第二通孔比所述第一通孔更靠近所述抗反流心脏瓣膜支架近端。
优选地，所述第一通孔的孔径大于所述第二通孔的孔径。
优选地，所述定位件包括拉线复合环，所述拉线复合环固定连接至所述定位件，且位于所述定位件朝向所述抗反流心脏瓣膜支架近端的一侧，所述拉线复合环包括适于穿入拉线第二通孔，且构造成能被X射线识别。
优选地，所述拉线复合环的表面设置不透X射线标记层或者高密度金属镀层；或者，
所述拉线复合环的外部轮廓被设置成葫芦型、三角星型、棱型或者猫爪型中的一种或多种。
优选地，所述拉线复合环设置在所述定位件远端，且相对于支架轴线向内倾斜。
优选地，所述支撑件包括适于穿入拉线的支撑件拉线环，所述支撑件拉线环固定连接至所述支撑件，且位于所述支撑件朝向所述抗反流心脏瓣膜支架远端的一侧。
优选地，当所述抗反流心脏瓣膜支架处于压缩状态时，所述支撑件拉线环的位置与所述拉线复合环的位置对齐。
优选地，所述支撑件拉线环相对于所述支撑件向外倾斜，优选地，所述支撑件拉线环相对于所述支撑件向外倾斜角度为100°-160°。
在第三方面中，本申请提供一种抗反流心脏瓣膜支架，包括在该抗反流心脏支架处于伸展状态时靠近心尖的抗反流心脏支架远端以及在该抗反流心脏支架处于伸展状态时远 离心尖的抗反流心脏支架近端，所述抗反流心脏支架近端包括连接件以及设置在相邻连接件之间的定位件和紧固件，其特征在于，所述紧固件比所述定位件更靠近所述抗反流心脏支架远端，定位件远端为朝向所述抗反流心脏支架远端凸起的杆，所述定位件设置在原生心脏瓣膜瓣叶的一侧，且所述紧固件设置在原生心脏瓣膜瓣叶的另一侧；
所述定位件包括拉线复合环，所述拉线复合环固定连接至所述定位件，且位于所述定位件朝向所述抗反流心脏支架近端的一侧；
所述抗反流心脏瓣膜支架还包括支撑件，所述支撑件包括第一支撑臂、第二支撑臂以及连接所述第一支撑臂和所述第二支撑臂的支撑件远端，所述第一支撑臂固定连接至第一连接件，所述第二支撑臂固定连接至第二连接件，所述第一连接件与所述第二连接件相邻；
所述支撑件远端与所述拉线复合环之间设置有连接机构。
优选地，所述连接机构为连杆或者折线结构。
优选地，所述连接机构包括第一连杆、第二连杆以及连接第一连杆和第二连杆的菱形方格，所述第一连杆的一端固定连接至拉线复合环，所述第二连杆的另一端固定连接至支撑件，且所述第一连杆的纵向轴线和第二连杆的纵向轴线在同一直线上。
优选地，所述第一连杆的长度小于所述第二连杆的长度。
优选地，所述连接机构包括第一连杆、第二连杆以及用于连接该第一连杆和第二连杆的弯曲连接部，其中所述第一连杆的一端连接有一个格连杆Ⅰ，所述格连杆Ⅰ的另一端固定连接格连杆Ⅱ，所述格连杆Ⅱ的另一端固定连接于第二连杆的一端，优选的，所述格连杆Ⅰ与格连杆Ⅱ通过弯曲连接部固定连接，其中弯曲连接部的宽度小于格连杆Ⅰ及格连杆Ⅱ的宽度。
优选地，所述连接结构采用S型的结构设计，其中第一连杆通过三根连杆与第二连杆固定连接。
在第四方面中，本申请提供一种抗反流心脏瓣膜支架，其特征在于，所述抗反流心脏瓣膜支架近端包括连接件以及设置在相邻连接件之间定位件和紧固件，所述紧固件用于固定人工心脏瓣膜瓣叶；
所述紧固件包括第一紧固弧、第二紧固弧以及连接所述第一紧固弧和所述第二紧固弧的紧固件远端；
所述抗反流心脏瓣膜支架远端包括卡位端，该卡位端包括相互连接的若干卡位端结构单元，构成所述卡位端结构单元的杆的宽度中央小两头大。
优选地，所述卡位端结构单元为菱形方格，所述卡位端包括设置成一层且相互连接的 18个卡位端结构单元。
优选地，相邻卡位端结构单元连接区域分别沿着所述抗反流心脏瓣膜支架的周向和纵向延伸预定长度，沿着所述抗反流心脏瓣膜支架的周向方向，所述相邻卡位端结构单元连接区域包括朝向其凹陷的弯曲结构。
优选地，所述卡位端和所述紧固件之间设置有加强网，所述加强网的远端固定至所述卡位端，所述加强网的近端固定连接至相邻紧固件的不同紧固弧之间。
优选地，所述加强网包括若干相互连接的加强网结构单元，所述加强网近端一侧的加强网结构单元固定连接至第一紧固件的第二紧固弧，且所述加强网近端的另一侧的加强网结构单元固定连接至第二紧固件的第一紧固弧。
优选地，所述加强网包括沿着从心脏瓣膜支架远端到心脏瓣膜支架近端的方向依次设置的第一自膨胀弧、第二自膨胀弧和第三自膨胀弧；
其中，所述第一自膨胀弧的一端与紧固件的第一紧固弧固定连接，另一端与相邻紧固件的第二紧固弧固定连接，且朝向心脏瓣膜支架远端凸起；
其中，所述第二自膨胀弧的两端分别固定连接至所述第一自膨胀弧，且朝向心脏瓣膜支架近端凸起；
其中，所述第三自膨胀弧的一端与紧固件的第一紧固弧固定连接，另一端与相邻紧固件的第二紧固弧固定连接，且朝向心脏瓣膜支架远端凸起；
其中，所述第二自膨胀弧和所述第三自膨胀弧之间存在间隙。
优选地，当心脏瓣膜支架处于扩展状态时，紧固件的第一紧固弧与相邻紧固件的第二紧固弧形成第一圆角；第二自膨胀弧具有第二圆角，第三自膨胀弧具有第三圆角，其中第三圆角不答应第一圆角，第二圆角大于第一圆角。
优选地，所述加强网由曲自膨弧、联结格及第三自膨弧组成，其中所述曲自膨弧由四段组成，分别为曲臂Ⅰ、曲臂Ⅱ、曲臂Ⅲ、曲臂Ⅳ，其中曲臂Ⅰ、曲臂Ⅳ分别连接紧固弧靠近远端的0.25到0.33处，其中曲臂Ⅰ、曲臂Ⅱ的远端固定连接，且连接处与卡位端连接，其中曲臂Ⅲ、曲臂Ⅳ的远端固定连接，且连接处与卡位端连接，其中曲臂Ⅱ、曲臂Ⅲ的近端固定连接，且连接处固定连接联结格，联结格包括两个联结臂。
优选地，所述联结格的联结臂上设置有至少一个适于拉线穿过的联结孔。
优选地，所述卡位端结构单元为菱形结构，加强网远端的加强网结构单元与卡位端的一个卡位端结构单元公用一个顶点，加强网远端的加强网结构单元与紧固件的紧固弧共用一条或者两条边。
优选地，构成所述加强网结构单元的杆的宽度中央小两头大。
优选地，沿着从所述心脏瓣膜支架近端到所述心脏瓣膜支架远端的轴向方向，所述加强网依次包括相互连接的三层，第一层包括一个加强网结构单元，第二层包括两个加强网结构单元，第三层包括一个加强网结构单元；
其中，第一层的加强网结构单元与其左边的紧固件的第二紧固弧共用一条边，且与其右边的紧固件的第一紧固弧共用一条边；
其中，第二层左侧的加强网结构单元与其左边的紧固件的第二紧固弧共用一条边，第二层右侧的加强网结构单元与与其右边的紧固件的第一紧固弧共用一条边；
其中，第三层的加强网结构单元与卡位端结构单元共用一个顶点。
优选地，加强网第二层的加强网结构单元连接区域分别沿着所述抗反流心脏瓣膜支架的周向和纵向延伸预定长度，沿着所述抗反流心脏瓣膜支架的周向方向，所述加强网结构单元连接区域包括朝向其凹陷的弯曲结构。
优选地，加强网的设置密度为每个紧固件对应一个加强网。
优选地，所述的抗反流心脏瓣膜支架还包括网格状覆膜，所述网格状覆膜固定在所述抗反流心脏瓣膜支架内侧。
优选地，所述网格状覆膜通过与抗反流心脏瓣膜支架的各部件缝合的方式固定至所述抗反流心脏瓣膜支架。
优选地，所述网格状覆膜由纵线和横线编织而成，纵线与横线的角度设置为60°～90°。
优选地，所述的抗反流心脏瓣膜支架还包括人工瓣叶，所述人工瓣叶包括人工瓣叶主体、耳部和紧固件，所述人工瓣叶主体的外部轮廓包括朝向该人工瓣叶凹陷的内凹区。
优选地，所述人工瓣叶还包括防磨边条，所述防磨边条设置在所述人工瓣叶主体的外部轮廓上。
优选地，所述人工瓣叶通过波浪状缝合线或者围绕缝合线的方式固定至所述抗反流心脏瓣膜支架的连接件。
与现有技术相比，本申请的有益效果在于：
(1)将原生心脏瓣膜瓣叶夹在支撑件和定位件之间，而将紧固件缝合到紧固件，使得原生心脏瓣膜瓣叶和人工心脏瓣膜瓣叶物理上完全分离，从而避免了原生心脏瓣膜瓣叶侵扰人工心脏瓣膜瓣叶；
(2)通过设置拉线复合环和支撑件拉线环，可以减少定位件和支撑件夹合原生心脏瓣膜瓣叶的难度，方便操作；
(3)由于原生瓣叶是由支撑件与定位件进行夹持，夹持相对更加牢靠，同时支撑件也利于该心脏瓣膜支架能够更加顺利的自膨，增加了自膨时的径向力。
附图说明
通过结合附图以及参考以下详细说明更充分地理解本发明的技术特征和优点。
图1显示根据本申请的一种实施方式的心脏瓣膜支架处于伸展状态时的立体图。
图2显示如图1所示的心脏瓣膜支架另一角度的立体图。
图3显示如图1所示的心脏瓣膜支架的展开图。
图4显示图3中区域B的局部放大图。
图5显示图3中区域C的局部放大图。
图6显示图1所示的心脏瓣膜支架安装人工心脏瓣膜瓣叶之后且处于伸展状态时的立体图。
图7显示图6所示立体图的俯视图。
图8显示根据本申请的另一种实施方式的心脏瓣膜支架处于伸展状态时的立体图。
图9显示图8所示的心脏瓣膜支架包括拉线时的立体图。
图10显示根据本申请的一种实施方式的抗反流心脏支架处于伸展状态时的立体图。
图11显示如图1所示的抗反流心脏支架的展开图。
图12显示图2中区域B的局部放大图。
图13显示图2中区域C的局部放大图。
图14A显示根据另一种实施方式的连接机构的示意图Ⅰ。
图14B显示根据另一种实施方式的连接机构的示意图Ⅱ。
图14C显示根据另一种实施方式的连接机构的示意图Ⅲ。
图14D显示图14A中区域B的局部放大图。
图15显示安装了人工心脏瓣膜瓣叶时的抗反流心脏支架立体图。
图16显示根据另一实施方式的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图17显示如图16所示的抗反流心脏支架的展开图。
图18显示图17中区域A的局部放大图。
图19显示图17中区域B的局部放大图。
图20显示根据另一实施方式的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图21显示如图20所示的抗反流心脏支架的展开图。
图22显示图21中区域A的局部放大图。
图23显示图21中区域B的局部放大图。
图24显示根据另一实施方式的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图25显示如图24所示的抗反流心脏支架的展开图。
图26显示图25中区域A的局部放大图。
图27显示根据另一实施方式的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图28显示图25中区域A的局部放大图。
图29A显示根据另一种实施方式的拉线复合环。
图29B显示根据另一种实施方式的拉线复合环。
图29C显示根据另一种实施方式的拉线复合环。
图29D显示根据另一种实施方式的拉线复合环。
图30显示根据另一实施方式的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图31显示图30中区域A的局部放大图。
图32显示如图30所示的抗反流心脏支架的展开图。
图33显示图32中区域A的局部放大图。
图34显示图32中区域B的局部放大图。
图35显示根据另一实施方式的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图36显示图35中区域A的局部放大图。
图37显示如图35所示的抗反流心脏支架的展开图。
图38显示图37中区域A的局部放大图。
图39显示图37中区域B的局部放大图。
图40显示根据另一种实施方式的安装网格状覆膜之后的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图41显示根据又一种实施方式的安装人工瓣叶之后的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图42显示根据一种实施方式的网格状覆膜的示意图。
图43显示根据一种实施方式的人工瓣叶的示意图。
图44显示图43中的内凹区的局部放大图。
图45显示根据另一种实施方式的人工瓣叶的示意图。
图46显示根据另一种实施方式的人工瓣叶的示意图。
图47显示根据又一种实施方式的安装人工瓣叶之后的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图48显示图47中区域A的局部放大图。
图49显示根据又一种实施方式的安装人工瓣叶之后的抗反流心脏瓣膜支架处于伸展状态时的立体图。
图50显示图49中区域A的局部放大图。
具体实施方式
除非另作定义，在本说明书和权利要求书中使用的技术术语或者科学术语应当为本发明所属技术领域内具有一般技能的人士所理解的通常意义。
在本发明的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”等的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中，除非另有说明，“多个”的含义是两个或两个以上。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是相连，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以通过具体情况理解上述术语在本发明中的具体含义。
如本文所述，当描述所述心脏瓣膜支架时，“近端”指的是所述心脏瓣膜支架呈现伸展状态时位于输送装置的一侧或者位于使用者操纵的端部的方向的一侧。相应地，“远端”指的是所述心脏瓣膜支架呈现伸展状态时远离输送装置的一侧或者远离使用者操纵的端部的方向的一侧。在本申请中，当描述所述心脏瓣膜支架时，“近心端”指的是所述心脏瓣膜支架呈现伸展状态时靠近心尖的一侧。相应地，“远心端”指的是所述心脏瓣膜支架呈现伸展状态时远离心尖的一侧。因为本文所述的心脏瓣膜支架经主动脉进行导管输送，所以远端与近心端指同一个位置，近端与远心端指同一个位置。
实施例1
本实施例提供一种心脏瓣膜支架，下面将参考图1-7详细描述本实施例的心脏瓣膜支架。
首先参考图1-3，其中图1显示根据实施例1的心脏瓣膜支架1处于伸展状态时的立体图，图2显示根据本实施例的心脏瓣膜支架1另一角度的立体图，且图3显示根据本实施例的心脏瓣膜支架1的展开图。如图1-3所示，本实施例所述的心脏瓣膜支架1可包括在该心脏瓣膜支架处于伸展状态时靠近心尖的心脏瓣膜支架远端以及在该心脏瓣膜支架处于伸展状态时远离心尖的心脏瓣膜支架近端。心脏瓣膜支架近端可包括连接件14以及设置在相邻连接件之间的支撑件11、定位件12和紧固件13。支撑件11和定位件12可用于固定原生心脏瓣膜瓣叶，同时紧固件13可用于固定人工心脏瓣膜瓣叶。
在本实施例中，支撑件11可包括第一支撑臂111、第二支撑臂112以及连接所述第一支撑臂111和第二支撑臂112的支撑件远端113。第一支撑臂111固定连接至第一连接件，第二支撑臂112固定连接至第二连接件，第一连接件与所述第二连接件相邻。类似地，定位件12可包括第一定位臂121、第二定位臂122以及连接所述第一定位臂和所述第二定位臂的定位件远端123。第一定位臂121固定连接至第一连接件，且第二定位臂122固定连接至第二连接件，所述第一连接件与所述第二连接件相邻。此外，紧固件13包括第一紧固弧131、第二紧固弧132以及连接所述第一紧固弧和所述第二紧固弧的紧固件远端133。所述第一紧固弧固定连接至第一连接件，所述第二紧固弧固定连接至第二连接件，所述第一连接件与所述第二连接件相邻。
在本实施例中，定位件12比所述支撑件11更靠近心脏瓣膜支架远端，紧固件13比定位件12更靠近所述心脏瓣膜支架远端。所述支撑件远端113和所述定位件远端123为朝向所述心脏瓣膜支架远端凸起的杆。所述支撑件11设置在原生心脏瓣膜瓣叶的一侧，且所述定位件12设置在原生心脏瓣膜瓣叶的另一侧。
与传统的心脏瓣膜支架相比，本文所述的心脏瓣膜支架还包括支撑件11，从而可将原生瓣叶夹在支撑件11与定位件12之间，支撑件11阻止了原生瓣叶侵扰人工瓣叶，而且由于原生瓣叶是由支撑件与定位件进行夹持，夹持相对更加牢靠，同时支撑件也利于该心脏瓣膜支架能够更加顺利的自膨，增加了自膨时的径向力。
在一种具体实施方式中，参考图3，当所述心脏瓣膜支架处于压缩状态时，所述第一支撑臂和所述第二支撑臂为线性的。当所述心脏瓣膜支架处于压缩状态时，所述第一定位臂和所述第二定位臂为线性的。将第一定位臂和第二定位臂设计成线性的是为了便于压缩，在进行充分压缩时，其占用的空间最小，即相邻第一支撑臂和第二支撑臂在压缩时会充分靠拢。而且线性的结构可以保证两者在压缩时不会干涉，因此，第一定位臂和第二定 位臂为线性的目的也是为了在压缩时会充分靠拢而不会干涉。另外，本支架采用一根钢管进行切割而成的，线性的设计也利于加工，减短了加工路径，降低了加工成本。
在一种具体实施方式中，所述定位件远端为抛物线结构，减小了定位件与窦底的接触应力，防止瓣环破裂。
在一种具体实施方式中，紧固件13的宽度比支撑件11和定位件12的宽度更宽，以提供强有力的支撑。
在一种具体实施方式中，当所述心脏瓣膜支架处于伸展状态时，所述支撑件具有第一张开角度，所述定位件具有第二张开角度，所述第二张开角度为4°-14°，且所述第一张开角度小于所述第二张开角度。定位件12与紧固件13产生一定的张角，便于定位件12捕捉瓣叶，减少手术难度。定位件12可用于防止瓣膜心室方向移位、促使人工瓣叶的远心端与原生瓣叶对齐，使其最大程度的还原原生瓣膜的功能，而同时保持人工瓣膜能够位于原有原生瓣膜的位置，因此人工瓣膜就很好的替代了原生瓣膜，降低了对血流的影响，减少血栓的发生，而第二张开角度为4°-14°的设置能够使得定位件12与紧固件13能夹紧原生瓣膜，防止原生瓣膜自由运动，同时原生瓣叶与支架紧密贴合，减少了瓣周漏。
在一种具体实施方式中，所述定位件远端最靠近所述心脏瓣膜支架远端之处与所述心脏瓣膜支架远端最远处(即下文描述的卡位端16)的垂直距离为4mm-8mm，优选地为6mm。
在一种具体实施方式中，卡位端的远端的相对于卡位端的近端外扩，并且卡位端的远端相对于卡位端的近端外扩的角度为6°-14°。需要产生外扩的原因是防止轻量化心脏瓣膜支架往主动脉方向位移，起到锚定作用。同时，而不能产生过大的角度原因是防止触碰希氏束，从而影响心脏的正常跳动，危及生命。
在一种具体实施方式中，参考图4和图5，心脏瓣膜支架远端还包括卡位端16和加强网15，在卡位端和16和加强网15之间存在镂空结构17。在本实施例中，卡位端16的菱形方格数量为18个，有效的增加该心脏瓣膜支架的可压缩性，而且构成菱形方格的杆宽是渐变的(中间细两头宽)，以优化支架抗疲劳性能。此外，因为本文所述的心脏瓣膜支架只包括18个菱形方格，本心脏瓣膜支架相邻紧固弧之间只需一个加强网15来连接卡位端即可，可以形成大量镂空部位，有效的降低了该心脏瓣膜支架的重量，而且便于压缩，而且构成菱形方格的杆宽是渐变的(中间细两头宽)，以优化支架抗疲劳性能。此外，加强网15的存在既可以增加支架的中部结构强度，也可以隔离自体瓣叶，以防侵犯到人工瓣叶。
接下来，将参考图4和图5,更加详细地描述卡位端16和加强网15的更多技术特征。
在一种具体实施方式中，首先参考图5，轻量化心脏瓣膜支架远端可包括卡位端16，该卡位端包括相互连接的若干卡位端结构单元161，构成所述卡位端结构单元161的杆162 的宽度中央小两头大。在图5所示的实施方式中，所述卡位端结构单元161的杆162可为对称的，其中间的宽度最小，然后朝着两头的方向平滑地变大，没有台阶性的突变。因此杆162的边缘是光滑的。
在一种具体实施方式中，卡位端结构单元161为菱形方格，卡位端16可包括设置成一层且相互连接的18个卡位端结构单元161。相邻卡位端结构单元161可通过公用一个顶点的方式相互连接。相邻卡位端结构单元161连接区域分别沿着所述轻量化心脏瓣膜支架的周向和纵向延伸预定长度，沿着所述轻量化心脏瓣膜支架的周向方向，所述相邻卡位端结构单元连接区域包括朝向其凹陷的弯曲结构163。因为杆162的两头的宽度最宽，在杆162在靠近卡位端结构单元161连接区的位置最宽且变形也就最困难，所以在压缩与膨胀的过程中会产生较大的应力，容易造成杆162在靠近卡位端结构单元161连接区的位置发生断裂。通过增加弯曲结构163，减小了杆62在靠近卡位端结构单元161连接区的位置的弯曲应力，可以该支架的卡位端的压缩和自膨胀过程，防止杆162发生断裂。
在另一种实施方式中，参考图3和图4，所述卡位端16和所述紧固件13之间设置有加强网15，所述加强网15的远端固定至所述卡位端16，所述加强网15的近端固定连接至相邻紧固件13的不同紧固弧之间。在一种优选的实施方式中，所述加强网15包括若干相互连接的加强网结构单元151，所述加强网近端一侧的加强网结构单元151固定连接至第一紧固件的第二紧固弧，且所述加强网近端的另一侧的加强网结构单元固定连接至第二紧固件的第一紧固弧。换句话说，加强网的近端分别连接至不同紧固件的不同紧固弧，从而实现固定连接。在一种具体实施方式中，所述卡位端结构单元151为菱形结构，加强网远端的加强网结构单元与卡位端的一个卡位端结构单元公用一个顶点，加强网远端的加强网结构单元与紧固件的紧固弧共用一条或者两条边。在一种具体实施方式中，与构成卡位端结构单元161的杆类似，构成所述加强网结构单元151的杆152的宽度中央小两头大。
在一种优选的实施方式中，沿着从所述心脏瓣膜支架近端到所述心脏瓣膜支架远端的轴向方向，所述加强网15依次包括相互连接的三层，第一层包括一个加强网结构单元，第二层包括两个加强网结构单元，第三层包括一个加强网结构单元。第一层的加强网结构单元与其左边的紧固件的第二紧固弧共用一条边，且与其右边的紧固件的第一紧固弧共用一条边。第二层左侧的加强网结构单元与其左边的紧固件的第二紧固弧共用一条边，第二层右侧的加强网结构单元与与其右边的紧固件的第一紧固弧共用一条边。第三层的加强网结构单元与卡位端结构单元共用一个顶点。在该实施方式中，加强网第二层的加强网结构单元连接区域分别沿着所述轻量化心脏瓣膜支架的周向和纵向延伸预定长度，沿着所述轻量化心脏瓣膜支架的周向方向，所述加强网结构单元连接区域包括朝向其凹陷的弯曲结构153。加强网结构单元连接区域的弯曲结构153的作用与卡位端结构单元连接区域的弯曲 结构163的作用类似，可以该支架的卡位端的压缩和自膨胀过程，防止杆152发生断裂。
接下来，将更加详细地描述本实施例的连接件14的结构。回到图1-图3，所述连接件14可包括连接块141、连接腹板142以及连接框架143。所述连接块141的一端形成所述心脏瓣膜支架近端，另一端通过所述连接腹板142与所述连接框架143连接，连接块141是为了与输送心脏瓣膜支架的输送器进行连接。
参考图3，沿着从所述心脏瓣膜支架近端到所述心脏瓣膜支架远端的方向，所述连接框架143可依次包括支撑件连接部分、定位件连接部分以及紧固件连接部分。在一种具体实施方式中，支撑件连接部分可为对称的，一边与第一支撑件的第一支撑臂连接，一边与相邻的第二支撑件的第二支撑臂连接。在一种优选的实施方式中，支撑臂与连接框架连接处的上边缘为平滑的弧线，且弧线的角度为100°-160°。同时，支撑臂与连接框架连接处的下边缘也为平滑的弧线，且弧线的角度为锐角。
回到图3，支撑件的支撑臂包括X点，第一支撑臂或者第二支撑臂在X点处弯曲，变形的点远离了连接框架，减少了受力集中。因为支撑件与定位件都与连接框架143连接，而连接框架143的空间有限，所以如果连接框架中的支撑件连接部分和定位件连接部分位置十分靠近。如果支撑件相对于连接框架的形变位置与定位件相对于连接框架形变的位置都是在连接处，而支撑件与定位件分别位于瓣膜两侧，所以如果两者相对于连接框架形变的位置太近，容易对靠近连接框架的原生瓣膜产生较大的剪切力，从而伤害瓣膜，而且变形区太过接近，也容易发生应力集中，造成支撑件/定位件与连接框架的连接处断裂。此时，需要增大两者相对于连接框架形变位置之间的距离，所以通过增加支撑件与连接框架的横截面积，同时保持支撑件与连接框架的流线型，便于输送器释放改支架，支撑臂与连接框架连接处的上边缘为平滑的弧线，且弧线的角度为100°-160°，而支撑臂与连接框架连接处的下边缘也为平滑的弧线，且弧线的角度为锐角是为了和下侧的定位件与连接框架连接处形成应力集中释放圆弧，防止形成应力集中点，造成支撑件/定位件与连接框架的连接处断裂。在本文所述的心脏瓣膜支架中，支撑件相对于连接框架的变形位置转移到远离连接框架的X点，解决了容易对靠近连接框架的原生瓣膜产生较大的剪切力的问题，而且两个变形区的位置变远，也防止了应力过于集中的问题。
在一种具体实施方式中，所述连接腹板的宽度小于所述连接块的宽度，且小于所述支撑件连接部分的宽度。在另一种实施方式中，所述连接框架包括中空的长条形缝合孔144。长条形缝合孔144的一端可设置在支撑件连接部分，另一端设置在定位件连接部分或者紧固件连接部分。长条形缝合孔144可以实现人工瓣叶的近端边缘直接穿过缝线孔进行缝合，而无需增加缝合垫片，人工瓣叶的边缘与紧固弧进行缝合，这样的缝合方式，相对传统的使用垫片与支架挤压固定瓣叶的方式，首先减少了支架的外附加的零部件，而且没有了垫 片，也有利于支架的进一步压缩，如果有垫片，不仅仅影响支架压缩，甚至有时在支架压缩支架较小的情况下会损坏人工瓣叶。
在另一种实施方式中，所述定位件可包括拉线复合环124，所述拉线复合环固定连接至所述定位件，且位于所述定位件朝向所述心脏瓣膜支架近端的一侧，所述拉线复合环包括第一通孔1241和第二通孔1242，所述第一通孔用于安装标记，所述第二通孔适于穿入拉线，且所述第二通孔比所述第一通孔更靠近所述心脏瓣膜支架近端。在一种具体实施方式中，所述第一通孔的孔径大于所述第二通孔的孔径。定位件12的远端设置的拉线复合环结构，将拉线与标记“marker”(标记是不透射线的)的安装结合到一个位置，有效的降低了产品的空间占有率。利用一个位置，可以实现定位件的开合控制与定位，不仅提高了产品的压缩性能，利于产品使用导管进行输送，而且定位件可以张开还利于降低手术操作的难度。拉线复合环结构有两个通孔，大孔是为了放置marker点，以便于植入精准定位，确保定位件触及窦底，小孔方便穿入拉线，在植入过程中，通过拉线控制定位件张角，方便捕获瓣叶，减小操作难度。在一种优选的实施方式中，所述拉线复合环设置在所述定位件远端，且相对于支架轴线向内倾斜，防止支架晃动过程中，拉线复合环近端碰撞主动脉壁，从而损伤主动脉，严重的可能会导致使用者发生主动脉夹层，而威胁使用者生命。从而可通过拉线将定位件向心脏瓣膜支架外部牵拉。
在一种具体实施方式中，参考图4和图5，心脏瓣膜支架远端还包括卡位端16和加强网15，在卡位端和16和加强网15之间存在镂空结构17。在本实施例中，卡位端16的菱形方格数量为18个，有效的增加该心脏瓣膜支架的可压缩性，而且构成菱形方格的杆宽是渐变的(中间细两头宽)，以优化支架抗疲劳性能。此外，因为本文所述的心脏瓣膜支架只包括18个菱形方格，本心脏瓣膜支架相邻紧固弧之间只需一个加强网15来连接卡位端即可，可以形成大量镂空部位，有效的降低了该心脏瓣膜支架的重量，而且便于压缩，而且构成菱形方格的杆宽是渐变的(中间细两头宽)，以优化支架抗疲劳性能。此外，加强网15的存在既可以增加支架的中部结构强度，也可以隔离自体瓣叶，以防侵犯到人工瓣叶。
在附图所示的实施方式中，心脏瓣膜支架可包括3个结构相同的支撑件、定位件、紧固件和连接件。相邻的连接件通过支撑件、定位件和紧固件相连。同时，相邻的支撑件、定位件和紧固件又通过连接件相连。当心脏瓣膜支架处于伸展状态时，基本上成圆筒状。人工心脏瓣膜瓣叶则可夹在支撑件和定位件之间，如图6和7所示。
实施例2
实施例2与实施例1的不同之处在于所述支撑件包括适于穿入拉线的支撑件拉线环 114。
参考图8和图9，所述支撑件拉线环114固定连接至所述支撑件，且位于所述支撑件朝向所述心脏瓣膜支架远端的一侧。在实施例1中结合附图对心脏瓣膜支架特征的描述也适用于本实施例，在此不再赘述。
在一种具体实施方式中，当所述心脏瓣膜支架处于压缩状态时，所述支撑件拉线环的位置与所述拉线复合环的位置对齐。在一种具体实施方式中，所述支撑件拉线环相对于所述支撑件向外倾斜，优选地，所述支撑件拉线环相对于所述支撑件向外倾斜角度α为100°-160°，从而支撑件拉线环相对于支架的轴线向外倾斜，这样的设置使得该支撑件拉线环不会干涉到人工瓣叶，而且此时支撑件拉线环朝向瓣膜，能够使得瓣膜更加牢靠的固定在支撑件与定位件之间。
本实施例的心脏瓣膜支架可降低实施例1将原生瓣叶夹合到定位件与支撑件之间的难度，在支撑件的远端增加拉线环，通过一根拉线3控制定位件，一根拉线3控制支撑件，使得定位件向外侧打开，而支撑件向内侧弯曲，从而使两者形成较大的间隙，便于将原生瓣叶夹入定位件与支撑件之间。
实施例3
本实施例提供一种抗反流心脏支架，实施例3与实施例1的不同之处在于支撑件和定位件之间设置有连接结构。下面将参考图10-13详细描述本实施例的抗反流心脏支架。
首先参考图10和图11，其中图10显示根据本实施例的抗反流心脏支架1处于伸展状态时的立体图，图11显示根据本实施例的抗反流心脏支架1的展开图。
如图10和图11所示，本实施例所述的抗反流心脏支架1可包括在该抗反流心脏支架处于伸展状态时靠近心尖的抗反流心脏支架远端以及在该抗反流心脏支架处于伸展状态时远离心尖的抗反流心脏支架近端。抗反流心脏支架近端可包括连接件14以及设置在相邻连接件之间的定位件12和紧固件13。紧固件13可用于固定人工心脏瓣膜瓣叶。
在本实施例中，支撑件11可包括第一支撑臂111、第二支撑臂112以及连接所述第一支撑臂111和第二支撑臂112的支撑件远端113。第一支撑臂111固定连接至第一连接件，第二支撑臂112固定连接至第二连接件，第一连接件与所述第二连接件相邻。类似地，定位件12可包括第一定位臂121、第二定位臂122以及连接所述第一定位臂和所述第二定位臂的定位件远端123。第一定位臂121固定连接至第一连接件，且第二定位臂122固定连接至第二连接件，所述第一连接件与所述第二连接件相邻。此外，紧固件13包括第一紧固弧131、第二紧固弧132以及连接所述第一紧固弧和所述第二紧固弧的紧固件远端133。所述第一紧固弧固定连接至第一连接件，所述第二紧固弧固定连接至第二连接件，所述第 一连接件与所述第二连接件相邻。
在本实施例中，定位件12比支撑件11更靠近抗反流心脏支架远端，紧固件13比定位件12更靠近所述抗反流心脏支架远端。支撑件远端113和定位件远端123为朝向所述抗反流心脏支架远端凸起的杆。定位件12设置在原生心脏瓣膜瓣叶的一侧，且紧固件13设置在原生心脏瓣膜瓣叶的另一侧。
与传统的抗反流心脏支架相比，本文所述的抗反流心脏支架还包括支撑件11，支撑件11使得该抗反流心脏支架能够更加顺利地自膨，增加了自膨时的径向力。与此同时，定位件12上设置有拉线复合环124，拉线复合环124和支撑件11之间设置有连接机构18。
在一种具体实施方式中，通过连接机构18将支撑件远端113与拉线复合环124连接在一起。如果连接机构、支撑件及定位件的刚度足够强，可以认为三者就是一个整体。设置连接机构18的有益效果如下所述。为了便于描述，将连接机构、支撑件及定位件形成的整体为夹合组件。首先，因为夹合组件在夹合瓣膜后，由于支架一直受到血液的冲刷，而且人也是运动的，所以支架并不是完全相对于瓣膜是静止的状态，而是相对的动态过程。所以夹合组件受力情况也是不断变化的，是一直变形动作的状态，即使动作幅度比较小，所以夹合组件相对与连接位置容易发生疲劳断裂，而三者结合的夹合组件，与连接件有两个连接点，而每一个连接处的截面积小，在变形时产生的内应力小，增加了疲劳寿命。其次，夹合组件的连接机构的设计，主要是防止支撑件和定位件各自运动，产生不一致的夹合力，例如：支撑件夹合较紧，而定位件较松，则定位件的设置失去了夹合作用。而相反，定位件夹合较紧，支撑件较松，则支撑件的设置失去了夹合作用。所以通过连接机构将两者连接到一起，使其共同运动，进一步解释，支撑件和定位件在打开的过程中(假设不设置连接机构)，两者的远端的距离一直是变化的，而如果通过连接机构将两者进行连接，那么其两者远端的距离将不再改变，所以就限制了夹合组件的张开角度，或说增加夹合组件打开时所需要的力，因为此时两者不仅仅是需要克服张开时的力，还需要有更多的力去实现两者的变形而使得两者的远端的距离保持不变，所以增强了夹合组件在夹紧瓣膜时的力，不容易松开。
在本实施例中，连接机构18可为一根连杆。在另一种实施方式中，连接机构18也可为折线结构。在一种具体实施方式中，所述拉线复合环124固定连接至所述定位件12，且位于所述定位件12朝向所述抗反流心脏支架近端的一侧。
在一种优选的实施方式中，所述拉线复合环包括第一通孔1241和第二通孔1242，所述第一通孔用于安装标记，所述第二通孔适于穿入拉线，且所述第二通孔比所述第一通孔更靠近所述抗反流心脏支架近端。在一种具体实施方式中，所述第一通孔的孔径大于所述第二通孔的孔径。定位件12的远端设置的拉线复合环结构，将拉线与标记“marker”(标 记是不透射线的)的安装结合到一个位置，有效的降低了产品的空间占有率。利用一个位置，可以实现定位件的开合控制与定位，不仅提高了产品的压缩性能，利于产品使用导管进行输送，而且定位件可以张开还利于降低手术操作的难度。拉线复合环结构有两个通孔，大孔是为了放置marker点，以便于植入精准定位，确保定位件触及窦底，小孔方便穿入拉线，在植入过程中，通过拉线控制定位件张角，方便捕获瓣叶，减小操作难度。在一种优选的实施方式中，所述拉线复合环设置在所述定位件远端，且相对于支架轴线向内倾斜。从而可通过拉线将定位件向抗反流心脏支架外部牵拉。
拉线复合环和支撑件之间的连接机构使得能同步控制定位件和支撑件的开合，增加了抗反流心脏支架的径向操控性。连接机构的设置还增加了人工心脏瓣膜瓣叶与人工抗反流心脏支架的接触面积。如上所述，这种设置可以增加人工抗反流心脏支架的耐疲劳性能。
在一种具体实施方式中，参考图11，当所述抗反流心脏支架处于压缩状态时，所述第一支撑臂和所述第二支撑臂为线性的。当所述抗反流心脏支架处于压缩状态时，所述第一定位臂和所述第二定位臂为线性的。当所述心脏瓣膜支架处于压缩状态时，所述第一定位臂和所述第二定位臂为线性的。将第一定位臂和第二定位臂设计成线性的是为了便于压缩，在进行充分压缩时，其占用的空间最小，即相邻第一支撑臂和第二支撑臂在压缩时会充分靠拢。而且线性的结构可以保证两者在压缩时不会干涉，因此，第一定位臂和第二定位臂为线性的目的也是为了在压缩时会充分靠拢而不会干涉。另外，本支架采用一根钢管进行切割而成的，线性的设计也利于加工，减短了加工路径，降低了加工成本。
在一种具体实施方式中，所述定位件远端为抛物线结构，减小了定位件与窦底的接触应力，防止瓣环破裂。
在一种具体实施方式中，当所述抗反流心脏支架处于伸展状态时，所述支撑件具有第一张开角度，所述定位件具有第二张开角度，所述第二张开角度为4°-14°，且所述第一张开角度小于所述第二张开角度。定位件12与紧固件13产生一定的张角，便于定位件12捕捉瓣叶，减少手术难度。定位件12可用于防止瓣膜心室方向移位、促使人工瓣叶的远心端与原生瓣叶对齐，使其最大程度的还原原生瓣膜的功能，而同时保持人工瓣膜能够位于原有原生瓣膜的位置，因此人工瓣膜就很好的替代了原生瓣膜，降低了对血流的影响，减少血栓的发生，而第二张开角度为4°-14°的设置能够使得定位件12与紧固件13能夹紧原生瓣膜，防止原生瓣膜自由运动，同时原生瓣叶与支架紧密贴合，减少了瓣周漏。
在一种具体实施方式中，所述定位件远端最靠近所述抗反流心脏支架远端之处与所述抗反流心脏支架远端最远处(即下文描述的卡位端16)的垂直距离为4mm-8mm，优选地为6mm。
在一种具体实施方式中，卡位端的远端的相对于卡位端的近端外扩，并且卡位端的远 端相对于卡位端的近端外扩的角度为6°-14°。需要产生外扩的原因是防止轻量化心脏瓣膜支架往主动脉方向位移，起到锚定作用。同时，而不能产生过大的角度原因是防止触碰希氏束，从而影响心脏的正常跳动，危及生命。
在一种具体实施方式中，紧固件13的宽度比支撑件11和定位件12的宽度更宽，以提供强有力的支撑。
接下来，将更加详细地描述本实施例的连接件14的结构。回到图1和图2，所述连接件14可包括连接块141、连接腹板142以及连接框架143。所述连接块141的一端形成所述抗反流心脏支架近端，另一端通过所述连接腹板142与所述连接框架143连接，连接块141是为了与输送抗反流心脏支架的输送器进行连接。
参考图2，沿着从所述抗反流心脏支架近端到所述抗反流心脏支架远端的方向，所述连接框架143可依次包括支撑件连接部分、定位件连接部分以及紧固件连接部分。在一种具体实施方式中，支撑件连接部分可为对称的，一边与第一支撑件的第一支撑臂连接，一边与相邻的第二支撑件的第二支撑臂连接。在一种优选的实施方式中，支撑臂与连接框架连接处的上边缘为平滑的弧线，且弧线的角度为100°-160°。同时，支撑臂与连接框架连接处的下边缘也为平滑的弧线，且弧线的角度为锐角。
回到图2，支撑件的支撑臂包括X点，第一支撑臂或者第二支撑臂在X点处弯曲，变形的点远离了连接框架，减少了受力集中。因为支撑件与定位件都与连接框架143连接，而连接框架143的空间有限，所以如果连接框架中的支撑件连接部分和定位件连接部分位置十分靠近。如果支撑件相对于连接框架的形变位置与定位件相对于连接框架形变的位置都是在连接处，而支撑件与定位件分别位于瓣膜两侧，所以如果两者相对于连接框架形变的位置太近，容易对靠近连接框架的原生瓣膜产生较大的剪切力，从而伤害瓣膜，而且变形区太过接近，也容易发生应力集中，造成支撑件/定位件与连接框架的连接处断裂。此时，需要增大两者相对于连接框架形变位置之间的距离，所以通过增加支撑件与连接框架的横截面积，同时保持支撑件与连接框架的流线型，便于输送器释放改支架，支撑臂与连接框架连接处的上边缘为平滑的弧线，且弧线的角度为100°-160°，而支撑臂与连接框架连接处的下边缘也为平滑的弧线，且弧线的角度为锐角是为了和下侧的定位件与连接框架连接处形成应力集中释放圆弧，防止形成应力集中点，造成支撑件/定位件与连接框架的连接处断裂。在本文所述的心脏瓣膜支架中，支撑件相对于连接框架的变形位置转移到远离连接框架的X点，解决了容易对靠近连接框架的原生瓣膜产生较大的剪切力的问题，而且两个变形区的位置变远，也防止了应力过于集中的问题。
在一种具体实施方式中，所述连接腹板的宽度小于所述连接块的宽度，且小于所述支撑件连接部分的宽度。在另一种实施方式中，所述连接框架包括中空的长条形缝合孔144。 长条形缝合孔144的一端可设置在支撑件连接部分，另一端设置在定位件连接部分或者紧固件连接部分。长条形缝合孔144可以实现人工瓣叶的近端边缘直接穿过缝线孔进行缝合，而无需增加缝合垫片，人工瓣叶的边缘与紧固弧进行缝合，这样的缝合方式，相对传统的使用垫片与支架挤压固定瓣叶的方式，首先减少了支架的外附加的零部件，而且没有了垫片，也有利于支架的进一步压缩，如果有垫片，不仅仅影响支架压缩，甚至有时在支架压缩支架较小的情况下会损坏人工瓣叶。
在一种具体实施方式中，参考图11到图13，抗反流心脏支架远端还包括卡位端16和加强网15，在卡位端和16和加强网15之间存在镂空结构17。在本实施例中，卡位端16的菱形方格数量为18个，有效的增加该抗反流心脏支架的可压缩性，而且构成菱形方格的杆宽是渐变的(中间细两头宽)，以优化支架抗疲劳性能。此外，因为本文所述的抗反流心脏支架只包括18个菱形方格，本抗反流心脏支架相邻紧固弧之间只需一个加强网15来连接卡位端即可，可以形成大量镂空部位，有效的降低了该抗反流心脏支架的重量，而且便于压缩，而且构成菱形方格的杆宽是渐变的(中间细两头宽)，以优化支架抗疲劳性能。此外，加强网15的存在既可以增加支架的中部结构强度，也可以隔离原生瓣叶，以防侵犯到人工瓣叶。
在附图所示的实施方式中，抗反流心脏支架可包括3个结构相同的支撑件、定位件、紧固件和连接件。相邻的连接件通过支撑件、定位件和紧固件相连。同时，相邻的支撑件、定位件和紧固件又通过连接件相连。当抗反流心脏支架处于伸展状态时，基本上成圆筒状。人工心脏瓣膜瓣叶则可夹在支撑件和定位件之间，如图15所示。
实施例4
实施例4与实施例3的不同之处在于连接机构18为含菱形方格的连杆。
具体来说，参考图14A，连接机构18可包括第一连杆181，第二连杆182，以及连接第一连杆181和第二连杆182的菱形方格183。第一连杆181的一端可固定连接到拉线复合环124的第二通孔，另一端固定连接到菱形方格183的一个顶点。第二连杆的一端可固定连接到支撑件，另一端固定连接到菱形方格183的另一个顶点。第一连杆181和第二连杆182的纵向轴线可在同一直线上，且第一连杆181的长度可小于第二连杆182的长度。
优选地，参考图14A和图14D，构成菱形方格183由两个格连杆Ⅰ1831和两个格连杆Ⅱ1832组成，其中两个格连杆Ⅰ1831的一端共同连接于第一连杆181的一端，两个格连杆Ⅱ1832的一端共同连接于第二连杆182的一端，所述格连杆Ⅰ1831的另一端(自由端)与格连杆Ⅱ1832的另一端(自由端)固定连接。
优选地，所述格连杆Ⅰ1831的另一端(自由端)与格连杆Ⅱ1832的另一端(自由端) 通过弯曲连接部184固定连接，其中弯曲连接部184的宽度L2小于格连杆Ⅰ1831及格连杆Ⅱ1832的宽度L1，这样使得格连杆Ⅰ1831与格连杆Ⅱ1832更容易相互活动，相对于直接通过一根连杆连接支撑件远端113与拉线复合环124的方式，降低了对定位件远端的柔性的影响。当例如人跳动或支架受到血液冲击时，会带动支架产生上下运动，此时定位件的远端会砰击主动脉瓣环底部，因为定位件通过复合拉线环连接有连接机构，所以造成定位件的远端高度较强，主动脉瓣环底部在多次碰撞下，会产生一定的损伤，而连接机构的具有一定的柔度，可以大幅度降低定位件远端的刚度，减少了定位件远端对主动脉瓣环底部的伤害。
最后，连接机构可包括折线结构。具体来说，参考图5B，其中折线结构可以是含有一半菱形方格的连杆，即折线结构包括：第一连杆181，所述第一连杆181的一端连接有一个格连杆Ⅰ1831，所述格连杆Ⅰ1831的另一端固定连接格连杆Ⅱ1832，所述格连杆Ⅱ1832的另一端固定连接于第二连杆182的一端，优选的，所述格连杆Ⅰ与格连杆Ⅱ通过弯曲连接部184固定连接，其中弯曲连接部184的宽度小于格连杆Ⅰ1831及格连杆Ⅱ1832的宽度，这样使得格连杆Ⅰ1831与格连杆Ⅱ1832更容易相互活动，相对于直接通过连杆连接支撑件远端113与拉线复合环124的方式，降低了对定位件远端的柔性的影响。当例如人跳动或支架受到血液冲击时，会带动支架产生上下运动，此时定位件的远端会砰击主动脉瓣环底部，因为定位件通过复合拉线环连接有连接机构，所以造成定位件的远端高度较强，主动脉瓣环底部在多次碰撞下，会产生一定的损伤，而连接机构的具有一定的柔度，可以大幅度降低定位件远端的刚度，减少了定位件远端对主动脉瓣环底部的伤害。
在另一种实施方式中，折线结构也可以如图14C所示，采用S型的结构设计，即第一连杆181通过三根连杆进行与第二连杆182固定连接，但折线结构并不限于此，第一连杆181可以通过若干根连杆进行与第二连杆182固定连接,优选的，第一连杆181与第二连杆182之间的若干根连杆可以通过弯曲连接部184进行连接。
对于上述连接机构18的实施例，需要声明的是，第一连杆181与第二连杆182的长度可以为零，即第一连杆181与第二连杆182之间的部件可以直接固定连接到支撑件远端113与拉线复合环124。
实施例5
实施例5与实施例1的不同之处在于加强网的结构不同。由于相邻紧固弧之间的角度较小，所以在该抗反流心脏瓣膜支架自膨胀时，容易自膨胀不到位，所以增加具有较大径向支撑力的加强网来实现其膨胀到预定尺寸。
参考图16-19，在本实施例中，所述加强网可包括沿着从心脏瓣膜支架远端到心脏瓣 膜支架近端的方向依次设置的第一自膨胀弧151、第二自膨胀弧152和第三自膨胀弧153。所述第一自膨胀弧的一端与紧固件的第一紧固弧固定连接，另一端与相邻紧固件的第二紧固弧固定连接，且朝向心脏瓣膜支架远端凸起。所述第二自膨胀弧的两端分别固定连接至所述第一自膨胀弧，且朝向心脏瓣膜支架近端凸起。所述第三自膨胀弧的一端与紧固件的第一紧固弧固定连接，另一端与相邻紧固件的第二紧固弧固定连接，且朝向心脏瓣膜支架远端凸起。所述第二自膨胀弧和所述第三自膨胀弧之间存在间隙。
在一种具体实施方式中，第一自膨弧的宽度大于第二自膨弧与第三自膨弧的宽度。第一自膨弧的尺寸相对第二自膨弧、第三自膨弧的尺寸大，而且跨度也最大，所以第一自膨弧需要提供更大的径向支撑力，依此保证其稳定支撑性能，所以第一自膨弧的宽度较宽，通过第一自膨弧、第二自膨弧、第三自膨弧构成的加强网设置，不仅依旧能够防止原生瓣膜侵入人工瓣膜，而且还解决了相邻紧固弧之间径向支撑力弱，自膨胀不到位的问题。
在一种具体实施方式中，第一自膨弧151由两个自膨臂Ⅰ1511构成，两个自膨臂Ⅰ的近端分别与两个紧固弧的中部位置固定连接，两个自膨臂Ⅰ的远端相互连接，且连接处与卡位端也固定连接。
在一种具体实施方式中，第二自膨弧152由两个自膨臂Ⅱ1521构成，两个自膨臂Ⅱ的远端分别与两个自膨臂Ⅰ的中部位置固定连接，两个自膨臂Ⅱ的近端相连接。自膨臂Ⅱ的长度不大于自膨臂Ⅰ长度的一半，优选的，自膨臂Ⅱ的长度为自膨臂Ⅰ长度的一半；
在一种具体实施方式中，第三自膨弧153由两个自膨臂Ⅲ1531构成，两个自膨臂Ⅲ的近端分别与两个紧固弧靠近近端的1/4处固定连接，两个自膨臂Ⅱ的远端相连接。自膨臂Ⅲ的长度不大于自膨臂Ⅱ的长度一半，优选的，自膨臂Ⅲ的长度为自膨臂Ⅱ长度的一半；
上述的设计，可以实现空间的合理利用，而且实现一个管材就可以实现其结构。
在本实施例中，当心脏瓣膜支架处于扩展状态时，紧固件的第一紧固弧与相邻紧固件的第二紧固弧形成第一圆角154；第二自膨胀弧具有第二圆角155，第三自膨胀弧具有第三圆角156。第三圆角156不大于其对应的相邻紧固弧形成的第一圆角154，因为越靠近紧固件近端的连接处，其空间越小，即材料的数量越多，即无材料占据空间越少，假设第三圆角156大于第一圆角154，该抗反流支架在被压缩时，两个自膨臂Ⅲ由于在两个紧固弧之间，所以两个自膨臂Ⅲ靠近的距离相对于两个紧固弧靠近的距离会更小，所以两个自膨臂Ⅲ会非常靠近，因此过大的第三圆角156会阻止两个自膨臂Ⅲ相互靠近，甚至阻挡相邻紧固弧靠近，所以会造成该反流支架压缩困难，甚至在压缩的过程中过大的第三圆角156会因为过渡的挤压而发生断裂，而第二圆角155对应的第二自膨弧152具有较大的跨度，所以需要提供足够大的支撑力以满足其实现较大的跨度，所以第二圆角155是大于第一圆角154的，显然，类似与上述第三圆角156与第二第一圆角154的大小关系的原因，第二 圆角155是大于所对应的第二自膨弧152的两个自膨臂Ⅱ1521连接处所形成的圆角。
在本实施例中，设置有第一自膨弧151、第二自膨弧152及第三自膨弧153，但是这并不代表加强网仅仅设置三个自膨弧，可以在第二自膨弧152的内侧设置一个新的自膨弧，而新的自膨弧的两个自膨臂连接处所形成的圆角不大于对应的第二自膨弧152的两个自膨臂Ⅱ1521连接处所形成的圆角，而且新的自膨弧的自膨臂的宽度并且小于其连接的自膨弧的自膨臂，以此减少空间占用率，新的自膨弧还可以再设置新的自膨弧，同理，第三自膨弧的内侧也可以设置新的自膨弧，但是加强网总的自膨弧数量不超过5个，以免影响该抗反流支架的压缩性能。
实施例6
本实施例提供一种不含支撑件的抗反流心脏瓣膜支架。
实施例6与实施例1的不同之处在于不含支撑件。
如图20-23所示，与实施例1所述的抗反流心脏瓣膜支架相比，本实施例的抗反流心脏瓣膜支架不包含支撑件。
通过取消支撑件，将定位件的近端与连接框架的近端连接，或定位件的近端与连接腹板的远端进行连接，并且定位件与连接腹板的连接处就形成连接框架的近端。上述结构设计因为取消了支撑筋，所以定位件的近端能够设置的更加靠近该抗反流心脏瓣膜支架近端的位置，进而增加了定位件近端到远端的距离，即增加了定位件夹合原生瓣叶的空间，所以在面对较大的主(肺)动脉的原生瓣叶时，定位件不会因为原生瓣叶的阻挡而无法插入窦底，定位件远端能够充分的插入到窦底，防止了定位件的远端因无法插入窦底而造成该抗反流心脏瓣膜支架在心脏心室舒张期间产生的较大的压差下发生位移，使得定位件远端会冲击到窦底的情况出现，而造成窦底伤害。
此外，如图23所示，卡位端的连杆采用中间细、两头粗的设计，优化了支架抗疲劳性能，但是中间位置过细，则会影响卡位端的径向支撑力。所以需要在保证卡位端径向支撑力的基础上，以优化支架卡位端的抗疲劳性能，所以卡位端连杆的最小宽度X应控制在最大宽度尺寸Y的0.53～0.93倍的范围内。
实施例7
本实施例提供一种不含支撑件的抗反流心脏瓣膜支架。
实施例7与实施例5的不同之处在于不含支撑件。
如图24-26所示，与实施例1所述的抗反流心脏瓣膜支架相比，本实施例的抗反流心脏瓣膜支架不包含支撑件。通过取消支撑件，将定位件的近端与连接框架的近端连接，(或 定位件的近端与连接腹板的远端进行连接，并且定位件与连接腹板的连接处就形成连接框架的近端)，上述结构设计因为取消了支撑筋，所以定位件的近端能够设置的更加靠近该抗反流心脏瓣膜支架近端的位置，进而增加了定位件近端到远端的距离，即增加了定位件夹合原生瓣叶的空间，所以在面对较大的主(肺)动脉的原生瓣叶时，定位件不会因为原生瓣叶的阻挡而无法插入窦底，定位件远端能够充分的插入到窦底，防止了定位件的远端因无法插入窦底而造成该抗反流心脏瓣膜支架在心脏心室舒张期间产生的较大的压差下发生位移，使得定位件远端会冲击到窦底的情况出现，而造成窦底伤害。
实施例8
实施例8与实施例7的不同之处在于拉线复合环的结构不同。
具体来说，传统的定位件远端设置有标记“marker”(标记是不透射线的)，虽然“marker”的设置在一定程度上便捷了支架的定位植入，但是却存在着“marker”脱落的风险。如果“marker”脱落后随着血液流动进入其它器官，这将会严重影响使用者的安全。而现在取消“marker”安装孔，而是将拉线复合环的表面设置不透X射线标记层或在拉线复合环的表面增加高密度金属镀层等，使得拉线复合环能够在X射线下更加清晰。
在另一种实施方式中，参考图27-29，可以把拉线复合环做成特别的形状，如葫芦型，三角星型，棱型，猫爪型等，便于操作人员能够快速识别拉线复合环，以此替代标记“marker”。
本领域技术人员易于理解，本实施例结合拉线复合环所描述的特征也适用于其它实施例。
实施例9
实施例9与实施例7的不同之处在于加强网的结构不一样。
参考图30到图34，在该实施例中，加强网15由曲自膨弧157、联结格158及第三自膨弧153组成。曲自膨弧157由四段组成，分别为曲臂Ⅰ1571、曲臂Ⅱ1572、曲臂Ⅲ1573、曲臂Ⅳ1574。其中曲臂Ⅰ、曲臂Ⅳ分别连接紧固弧靠近远端的0.25到0.33处(紧固件由两个紧固弧构成)，其中曲臂Ⅰ、曲臂Ⅱ的远端固定连接，且连接处与卡位端连接，其中曲臂Ⅲ、曲臂Ⅳ的远端固定连接，且连接处与卡位端连接，其中曲臂Ⅱ、曲臂Ⅲ的近端固定连接，且连接处固定连接联结格，联结格包括两个联结臂1581。
两个联结臂1581的远端位置相互连接，并且其连接处固定连接曲自膨弧，其中曲自膨弧的曲臂Ⅰ、曲臂Ⅱ、曲臂Ⅲ、曲臂Ⅳ的长度相等，两个联结臂的近端位置相互连接，并且其连接处固定连接第三自膨弧，第三自膨弧包括两个自膨臂Ⅲ，其中自膨臂Ⅲ的近端 与紧固弧连接，且连接点在靠近紧固弧近端Q长度的位置，Q值小于等于1/4的紧固弧长度，自膨臂Ⅲ的长度Z不小于0.8Q，从而实现联结格会支撑第三自膨弧和曲自膨弧，在一定程度上促进了该抗反流支架的自膨胀，不会阻挡牵拉第三自膨弧和曲自膨弧，而影响该抗反流支架膨胀，该数据的得出是通过计算发现，这里需要说明的，相邻紧固件的张开角度一般小于60°，当自膨臂Ⅲ的长度Z小于0.6Q时，联结格的轴向高度H，也就是第三自膨弧和曲自膨弧之间的距离，会随着该抗反流支架的膨胀而增大，从而无法达到支撑第三自膨弧和曲自膨弧的目的，所以取自膨臂Ⅲ的长度Z不小于0.8Q，其中0.6～0.8的区间主要是做系数缓冲区。
实施例10
实施例10与实施例9的不同之处在于加强网的结构不一样。
参考图35-39，在该实施方式中，联结格158的联结臂1581上设置有联结孔1582，其每个联结臂上的联结孔可以设置一个或多个，当联结孔设置一个时，设置在联结臂的中部。当联结孔设置多个时，联结孔均匀分布在联结臂上。此时，通过缝合线分别穿过两个联结臂上的联结孔，并拉紧缝合线，这里采用的缝合线是具有弹性的，为了实现联结格具有一定的灵活性，依旧可以有一定程度的周向长度L方向上的变形，但同时限制联结格在周向长度L上的增大，所以联结格的轴向高度H将会增大，所以联结格会提供一个更大的力去支撑第三自膨弧和曲自膨弧，从而更加促进了第三自膨弧的张开与曲自膨弧的张开，使得该抗反流支架能够自膨胀达到预期效果。
为了实现联结格的两个联结臂在膨胀时能够分别向两侧弯曲，联结臂为弧线结构，相对于联结格，其弧线结构的凹面朝向内侧，弧线结构的凸面朝向外侧。
实施例11
本实施例提供一种抗反流心脏瓣膜支架，其还包括网格状覆膜，所述网格状覆膜固定在所述抗反流心脏瓣膜支架内侧。
参考图40和41，在一种具体实施方式中，所述网格状覆膜3通过与抗反流心脏瓣膜支架1的各部件缝合的方式固定至所述抗反流心脏瓣膜支架。人工瓣叶2则可缝合到网格状覆膜3上。
传统的人工瓣叶缝合到抗反流心脏瓣膜支架上的方式为人工瓣叶与抗反流心脏瓣膜支架，例如紧固弧进行缝合，但是紧固弧表面人工是光滑的，那么人工瓣膜固定不牢靠，通过紧固弧设置为曲线形状，或增加固定孔，为了保证紧固弧的强度，所以增加紧固弧的宽度，这就使得抗反流心脏瓣膜支架的体积变大，造成抗反流心脏瓣膜支架的压缩困难， 无法达到预期的压缩抗反流心脏瓣膜支架。
由于自膨胀抗反流支架需要压缩的直径较小，所以在材料厚度及其宽度都受到了很大的限制，所以该抗反流支架希望在压缩时，不会受到过多的外力干扰，例如来自覆膜的作用力。
传统的抗反流支架采用的覆膜多为PET编织的材料，而编织的纹路多为横平竖直，即PET编织布的横线与纵线相互垂直90°，而在缝合时，PET编织布的纵线与该抗反流支架的轴线相互平行，而横线与该抗反流支架的周向方向相平行，所以在该抗反流支架压缩过程中，由于覆膜与支架相固定。所以，PET编织布的纵线长度是确定的，而该抗反流支架在压缩的过程中会增长，尤其是卡位端的菱形结构的连杆相互连接点中的上下两个连接点的长度会增加，而与其固定PET覆膜的纵线(下称：纵线)并不会增长，所以此时的纵线就会阻挡卡位端的菱形结构压缩边长，所以此时菱形结构在外力的作用下继续压缩，而纵线却一直阻挡菱形结构压缩，所以此时的卡位端的菱形结构在压缩和阻挡压缩的两个力的作用下，极易产生菱形结构的变形而损坏菱形结构。但是这里需要说明的是，传统的横平竖直的PET覆膜产生的阻挡压缩的力不仅仅作用于卡位端的菱形结构，也作用于加强网的菱形结构及紧固件，阻挡两者的压缩，从而影响整个支架的压缩，甚至其产生的阻止该抗反流支架的作用力在使得整个支架在压缩过程中造成支架损坏。
参考图40和图41，在一种具体实施方式中，该抗反流心脏瓣膜支架使用PET材料编织的网布进行覆膜，覆膜3通过与抗反流心脏瓣膜支架的各部件进行缝合，因为抗反流心脏瓣膜支架错综复杂，从而使得覆膜能够牢靠的固定在抗反流心脏瓣膜支架内侧。由于抗反流心脏瓣膜支架的尺寸会改变，人工瓣叶如果与抗反流心脏瓣膜支架相缝合，那么随着抗反流心脏瓣膜支架的变化，人工瓣叶的尺寸和形状也需要跟着变化，降低了人工瓣叶的通用性，增加了成本，而且因为需要保证人工瓣叶的性能参数符合要求，所以改变瓣膜大小和形状需要重新进行设计使其达到标准，所以人工瓣叶人工不具备通用性也会增加了设计人员的设计强度。
采用人工瓣叶与覆膜相结合的方式，与传统的使用整体人工瓣叶覆盖整个抗反流心脏瓣膜支架的方式相比，增加了抗反流心脏瓣膜支架的可压缩性，因为使用的PET材料编织的网布的厚度小于人工瓣叶，降低了对抗反流心脏瓣膜支架内部空间的占用，所以增加了抗反流心脏瓣膜支架的可压缩性。
人工瓣叶可包含一种或多种合成材料、工程化生物组织、生物瓣叶组织、心包组织、交联心包组织、主动脉根组织、经化学或生物加工/处理的组织，或它们的组合。在一些实施例中，心包组织选自但不限于由牛、马、猪、绵羊及人的组织或它们组合所组成的群组。
在本实施例中，人工瓣叶的远端固定方式不再是与紧固弓固定连接而是跨过紧固弓，与紧固弓与卡位端抗反流心脏瓣膜支架的覆膜固定连接，由于覆膜是可以使用缝合线任意穿透的，所以可以使人工瓣叶紧固的与覆膜进行连接，而且可以增加缝合的密度，使其人工瓣叶与覆膜之间的密封性能更好，防止了血液通过人工瓣叶与覆膜的结合位置发生泄漏，而且通过覆膜与人工瓣叶进行缝合，操作人员无需使缝合线频繁的绕过紧固弓或固定孔，降低了操作人员的劳动强度，提高了效率。
在一种具体实施方式中，人工瓣叶如果与支架相缝合，那么随着支架的变化，人工瓣叶也必然随着支架运动，而且支架的运动相对于覆膜是刚性的，即运动状态固定，所以人工瓣叶和支架缝合，在该抗反流支架压缩过程中，支架会对人工瓣叶产生撕扯，而人工瓣叶和覆膜相缝合，覆膜相对柔软，并允许一定程度的位移，所以不会对人工瓣叶产生强有力的撕扯力，保证了人工瓣叶的安全。
在一种具体实施方式中，为了覆膜能够适应该抗反流支架，对PET编织布的进行设计，改善了人工瓣叶与连接框架固定方式。
PET编织布通常可由纵线(经线)和横线(纬线)编织而成。参考图42，PET编织布的纵线与横线的角度设置为60°～90°。设置该角度的原因在于：卡位端及其加强网的菱形结构中的任意两个直接连接的连杆形成的夹角(锐角或钝角的补角)的范围是60°～90°，所以使得PET编织布的纵线与横线形成的夹角与菱形结构中的相连接的连杆形成的夹角(锐角或钝角的补角)一致。需要声明的是，当菱形结构中的相连接的连杆形成的夹角是90°时，PET编织布的纵线与横线的角度也为90°，而菱形结构中的相连接的连杆形成的夹角一般不小于60°，如果角度过小，会影响其周向支撑力。
而在缝合时，需要确保PET编织布的纵线与菱形结构的其中一个连杆平行固定在支架上，而由于横线与纵线形成的夹角与菱形结构中锐角是相同的，所以与该固定有PET编织布的连杆与直接连接的相邻连杆会与PET编织布的横线相平行。此时横线与该连杆进行固定。以此类推，卡位端及加强网的菱形结构的各个连杆会分别与PET编织布的纵线或横线平行并固定连接。此时在压缩该抗反流支架时，与菱形结构连杆固定连接的PET编织布会伴随连杆运动，而此时菱形结构的连杆的上下连接点之间也是通过若干根纵线与横线构成，而不是由一根纵线(横线)构成连接。在PET编织布的横线与纵线在伴随着菱形结构的连杆运动时，远离相对于该抗反流支架轴线倾斜的横线或纵线逐渐变成与轴线平行的状态，此时横线与纵线的两端的轴向距离(指沿着该抗反流支架的轴线方向的距离)会逐渐增大。此时PET编织布的轴线距离随着该抗反流支架压缩一起变长，从而不会阻挡该反流支架压缩变形。
在一种具体实施方式中，如图47和48所示，人工瓣叶的耳部403穿过连接框架143， 并绕过连接框架的侧柱使其耳部尾端由回到该抗反流支架的内部，并与人工瓣叶主体与耳部连接处的人工瓣叶相贴合，并通过波浪状缝合线5贯穿位于同一连接框架的人工瓣叶，将人工瓣叶耳部尾端紧密的与人工瓣叶结合，并且将相邻的人工瓣叶的主体与耳部连接处(下称：耳部连接处)紧密的贴合，实现了人工瓣叶的固定以及相邻人工瓣叶靠近支架侧的紧密结合。需要声明的是，波浪状折线是指缝合线按照波浪线的路径进行缝合，其主要目的是增大了人工瓣叶耳部尾端与人工瓣叶耳部连接处的接触面积，增加了稳定性，同时也增加了相邻人工瓣叶的耳部连接处的接触面积，防止了人工瓣叶靠近支架侧的血液反流。
在一种具体实施方式中，如图49和50所示，因为人工瓣叶具有一定的弹性，而仅仅使用波浪状缝合线固定人工瓣叶，在人工瓣叶的弹性作用下，会造成人工瓣叶相对连接框架的侧柱滑动，从而影响人工瓣叶的效果，所以需要增加人工瓣叶对侧柱的包裹力，所以增加围绕缝合线6。
第一个实施例，每一个相邻的围绕缝合线都是独立的，该围绕缝合线围绕连接框架一圈，使得人工瓣叶的耳部紧密的贴合侧柱。而相邻的围绕缝合线依次从波浪状缝合线两侧的凹谷处穿过，有效的防止了围绕缝合线仅仅撕拉波浪状缝合线一侧的人工瓣叶，影响人工瓣叶的性能及使用寿命。
第二个实施例，围绕缝合线自上而下是一个顺时针螺旋缠绕的围绕缝合线与另一个逆时针螺旋缠绕的围绕缝合线形成的，相对于上述的独立围绕缝合线，每一个螺旋缠绕的围绕缝合线采用一体的螺旋的围绕缝合线，操作简单，而且固定牢靠，没有过多的缝合线端头，增加了使用稳定性，这里的一个并不是指一根缝合线，也可以是一束缝合线即若干根缝合线，两个缝合线依次穿过波浪状缝合线两侧的凹谷，防止了连接框架因为缝合产生不对称的力，从而对人工瓣叶产生撕扯力，影响力人工瓣叶的性能及使用寿命。
在一种具体实施方式中，人工瓣叶设置的耳部相对于人工瓣叶主体上平线向下倾斜，其主要原因是：为了进一步的缩短该反流支架的长度，所以连接框架的位置距离人工瓣叶的远端相对于人工瓣叶的近端距离人工瓣叶的远端而言，距离会更短，所以人工瓣叶的耳部为了能够顺利放入连接框架内，所以需要向下倾斜，而且向下倾斜的两个人工瓣叶耳部在连接框架的作用下会相互平行，所以此时人工瓣叶主体上平线就会弯曲，利于工瓣叶的闭合。
在一种具体实施方式中，如图42-45所示，人工瓣叶2可包括人工瓣叶主体404、耳部403、紧固件401和内凹区402。在一种具体实施方式中，人工瓣叶主体设置为大体的V型，但是在人工瓣叶主体靠近远端的两侧设置有内凹区，其主要目的是适应紧固件，由于紧固件在压缩过程中会从曲型转变为直线型，传统的人工瓣叶在内凹区位置是外凸的(下 称外凸区)，这将会在紧固件变直的过程中产生较大的阻抗力，从而造成人工瓣叶缝合位置过渡挤压的情况，尤其是其外凸区的中点位置，产生的挤压情况是最严重的。而本设计的内凹区是内凹的，所以内凹区的中点到紧固件的距离短，即人工瓣叶的用料少，具有较大的空间容纳挤压过程中挤压的材料，所以在紧固件变直的过程中，不会对瓣叶的缝合位置产生过渡的挤压情况。
在一种具体实施方式中，参考图46，人工瓣叶主体的远端变远设置有防磨边条405，采用缝合的方式与人工瓣叶主体结合，其固定牢靠，而且防磨边条设置首先是增加了人工瓣叶主体远端的抗撕裂能力，其次是降低了人工瓣叶主体远端与覆膜的摩擦对人工瓣叶的损伤，提高了人工瓣叶的使用寿命，而且防磨边条的设置也相当于人工瓣叶与覆膜之间的缓冲层，有效的缓冲了人工瓣叶在开合过程中对覆膜的撕扯作用力，增加了该抗反流支架的使用寿命。
在该实施方式中，卡位端内侧覆膜即为防漏裙边。
在一种具体实施方式中，卡位端的远端设置有防漏裙边(图中未示出)，采用卡位端外侧也覆膜的方式，外侧覆膜远心端一直到紧固弓的近心端，其卡位端外侧覆膜可以是内侧覆膜外翻至外侧，也可以是单独一个覆膜，有效的防止反流支架产生侧漏，增加了该支架的防侧漏性能。
对于本领域技术人员而言，显然本发明不限于上述示范性实施例的细节，而且在不背离本发明的精神或基本特征的情况下，能够以其他的具体形式实现本发明。因此，无论从哪一点来看，均应将实施例看作是示范性的，而且是非限制性的，本发明的范围由所附权利要求而不是上述说明限定，因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。不应将权利要求中的任何附图标记视为限制所涉及的权利要求。

Claims (44)

  1. 一种抗反流心脏瓣膜支架，包括在该抗反流心脏瓣膜支架处于伸展状态时靠近心尖的抗反流心脏瓣膜支架远端以及在该抗反流心脏瓣膜支架处于伸展状态时远离心尖的抗反流心脏瓣膜支架近端，其特征在于，所述抗反流心脏瓣膜支架构造成能有效地避免原生心脏瓣膜瓣叶侵扰人工心脏瓣膜瓣叶。
  2. 如权利要求1所述的抗反流心脏瓣膜支架，包括在该抗反流心脏瓣膜支架处于伸展状态时靠近心尖的抗反流心脏瓣膜支架远端以及在该抗反流心脏瓣膜支架处于伸展状态时远离心尖的抗反流心脏瓣膜支架近端，其特征在于，所述抗反流心脏瓣膜支架近端包括连接件以及设置在相邻连接件之间的支撑件、定位件和紧固件，所述紧固件用于固定人工心脏瓣膜瓣叶；
    其中，所述支撑件包括第一支撑臂、第二支撑臂以及连接所述第一支撑臂和所述第二支撑臂的支撑件远端，所述第一支撑臂固定连接至第一连接件，所述第二支撑臂固定连接至第二连接件，所述第一连接件与所述第二连接件相邻；
    其中，所述定位件包括第一定位臂、第二定位臂以及连接所述第一定位臂和所述第二定位臂的定位件远端，所述第一定位臂固定连接至第一连接件，所述第二定位臂固定连接至第二连接件，所述第一连接件与所述第二连接件相邻；
    其中，所述紧固件包括第一紧固弧、第二紧固弧以及连接所述第一紧固弧和所述第二紧固弧的紧固件远端，所述第一紧固弧固定连接至第一连接件，所述第二紧固弧固定连接至第二连接件，所述第一连接件与所述第二连接件相邻；
    其中，所述定位件比所述支撑件更靠近所述抗反流心脏瓣膜支架远端，所述紧固件比所述定位件更靠近所述抗反流心脏瓣膜支架远端，所述支撑件远端和所述定位件远端为朝向所述抗反流心脏瓣膜支架远端凸起的杆，所述支撑件设置在原生心脏瓣膜瓣叶的一侧，且所述定位件设置在原生心脏瓣膜瓣叶的另一侧。
  3. 如权利要求2所述的抗反流心脏瓣膜支架，其特征在于，当所述抗反流心脏瓣膜支架处于压缩状态时，所述第一支撑臂和所述第二支撑臂为线性的。
  4. 如权利要求2所述的抗反流心脏瓣膜支架，其特征在于，当所述抗反流心脏瓣膜支架处于压缩状态时，所述第一定位臂和所述第二定位臂为线性的。
  5. 如权利要求4所述的抗反流心脏瓣膜支架，其特征在于，所述定位件远端为抛物线结构。
  6. 如权利要求2所述的抗反流心脏瓣膜支架，其特征在于，当所述抗反流心脏瓣膜支架处于伸展状态时，所述支撑件具有第一张开角度，所述定位件具有第二张开角度，所述第二张开角度为4°-14°，且所述第一张开角度小于所述第二张开角度。
  7. 如权利要求2所述的抗反流心脏瓣膜支架，其特征在于，所述定位件远端最靠近所述抗反流心脏瓣膜支架远端之处与所述抗反流心脏瓣膜支架远端最远处的垂直距离为4mm-8mm，优选地为6mm。
  8. 如权利要求2所述的抗反流心脏瓣膜支架，其特征在于，所述连接件包括连接块、连接腹板以及连接框架，所述连接块的一端形成所述抗反流心脏瓣膜支架近端，另一端通过所述连接腹板与所述连接框架连接，沿着从所述抗反流心脏瓣膜支架近端到所述抗反流心脏瓣膜支架远端的方向，所述连接框架依次包括支撑件连接部分、定位件连接部分以及紧固件连接部分。
  9. 如权利要求8所述的抗反流心脏瓣膜支架，其特征在于，所述连接腹板的宽度小于所述连接块的宽度，且小于所述支撑件连接部分的宽度。
  10. 如权利要求8所述的抗反流心脏瓣膜支架，其特征在于，所述连接框架包括中空的长条形缝合孔。
  11. 如权利要求2-10中任一项所述的抗反流心脏瓣膜支架，其特征在于，所述定位件包括拉线复合环，所述拉线复合环固定连接至所述定位件，且位于所述定位件朝向所述抗反流心脏瓣膜支架近端的一侧，所述拉线复合环包括第一通孔和第二通孔，所述第一通孔用于安装标记，所述第二通孔适于穿入拉线，且所述第二通孔比所述第一通孔更靠近所述抗反流心脏瓣膜支架近端。
  12. 如权利要求11所述的抗反流心脏瓣膜支架，其特征在于，所述第一通孔的孔径大于所述第二通孔的孔径。
  13. 如权利要求2-10中任一项所述的抗反流心脏瓣膜支架，其特征在于，所述定位件包括拉线复合环，所述拉线复合环固定连接至所述定位件，且位于所述定位件朝向所述抗反流心脏瓣膜支架近端的一侧，所述拉线复合环包括适于穿入拉线第二通孔，且构造成能被X射线识别。
  14. 如权利要求13所述的抗反流心脏瓣膜支架，其特征在于，所述拉线复合环的表面设置不透X射线标记层或者高密度金属镀层；或者，
    所述拉线复合环的外部轮廓被设置成葫芦型、三角星型、棱型或者猫爪型中的一种或多种。
  15. 如权利要求11所述的抗反流心脏瓣膜支架，其特征在于，所述拉线复合环设置在所述定位件远端，且相对于支架轴线向内倾斜。
  16. 如权利要求11所述的抗反流心脏瓣膜支架，其特征在于，所述支撑件包括适于穿入拉线的支撑件拉线环，所述支撑件拉线环固定连接至所述支撑件，且位于所述支撑件朝向所述抗反流心脏瓣膜支架远端的一侧。
  17. 如权利要求16所述的抗反流心脏瓣膜支架，其特征在于，当所述抗反流心脏瓣膜支架处于压缩状态时，所述支撑件拉线环的位置与所述拉线复合环的位置对齐。
  18. 如权利要求16所述的抗反流心脏瓣膜支架，其特征在于，所述支撑件拉线环相对于所述支撑件向外倾斜，优选地，所述支撑件拉线环相对于所述支撑件向外倾斜角度为100°-160°。
  19. 如权利要求1所述的抗反流心脏瓣膜支架，包括在该抗反流心脏支架处于伸展状态时靠近心尖的抗反流心脏支架远端以及在该抗反流心脏支架处于伸展状态时远离心尖的抗反流心脏支架近端，所述抗反流心脏支架近端包括连接件以及设置在相邻连接件之间的定位件和紧固件，其特征在于，所述紧固件比所述定位件更靠近所述抗反流心脏支架远端，定位件远端为朝向所述抗反流心脏支架远端凸起的杆，所述定位件设置在原生心脏瓣膜瓣叶的一侧，且所述紧固件设置在原生心脏瓣膜瓣叶的另一侧；
    所述定位件包括拉线复合环，所述拉线复合环固定连接至所述定位件，且位于所述定位件朝向所述抗反流心脏支架近端的一侧；
    所述抗反流心脏瓣膜支架还包括支撑件，所述支撑件包括第一支撑臂、第二支撑臂以及连接所述第一支撑臂和所述第二支撑臂的支撑件远端，所述第一支撑臂固定连接至第一连接件，所述第二支撑臂固定连接至第二连接件，所述第一连接件与所述第二连接件相邻；
    所述支撑件远端与所述拉线复合环之间设置有连接机构。
  20. 如权利要求19所述的抗反流心脏瓣膜支架，其特征在于，所述连接机构为连杆或者折线结构。
  21. 如权利要求20所述的抗反流心脏瓣膜支架，其特征在于，所述连接机构包括第一连杆、第二连杆以及连接第一连杆和第二连杆的菱形方格，所述第一连杆的一端固定连接至拉线复合环，所述第二连杆的另一端固定连接至支撑件，且所述第一连杆的纵向轴线和第二连杆的纵向轴线在同一直线上。
  22. 如权利要求21所述的抗反流心脏瓣膜支架，其特征在于，所述第一连杆的长度小于所述第二连杆的长度。
  23. 如权利要求20所述的抗反流心脏瓣膜支架，其特征在于，所述连接机构包括第一连杆、第二连杆以及用于连接该第一连杆和第二连杆的弯曲连接部，其中所述第一连杆的一端连接有一个格连杆Ⅰ，所述格连杆Ⅰ的另一端固定连接格连杆Ⅱ，所述格连杆Ⅱ的另一端固定连接于第二连杆的一端，优选的，所述格连杆Ⅰ与格连杆Ⅱ通过弯曲连接部固定连接，其中弯曲连接部的宽度小于格连杆Ⅰ及格连杆Ⅱ的宽度。
  24. 如权利要求20所述的抗反流心脏瓣膜支架，其特征在于，所述连接结构采用S型的结构设计，其中第一连杆通过三根连杆与第二连杆固定连接。
  25. 如权利要求1所述的一种抗反流心脏瓣膜支架，其特征在于，所述抗反流心脏瓣膜支架近端包括连接件以及设置在相邻连接件之间定位件和紧固件，所述紧固件用于固定人工心脏瓣膜瓣叶；
    所述紧固件包括第一紧固弧、第二紧固弧以及连接所述第一紧固弧和所述第二紧固弧的紧固件远端；
    所述抗反流心脏瓣膜支架远端包括卡位端，该卡位端包括相互连接的若干卡位端结构单元，构成所述卡位端结构单元的杆的宽度中央小两头大。
  26. 如权利要求25所述的抗反流心脏瓣膜支架，其特征在于，所述卡位端结构单元为菱形方格，所述卡位端包括设置成一层且相互连接的18个卡位端结构单元。
  27. 如权利要求26所述的心脏瓣膜支架，其特征在于，相邻卡位端结构单元连接区域分别沿着所述抗反流心脏瓣膜支架的周向和纵向延伸预定长度，沿着所述抗反流心脏瓣膜支架的周向方向，所述相邻卡位端结构单元连接区域包括朝向其凹陷的弯曲结构。
  28. 如权利要求25-27中任一项所述的抗反流心脏瓣膜支架，其特征在于，所述卡位端和所述紧固件之间设置有加强网，所述加强网的远端固定至所述卡位端，所述加强网的近端固定连接至相邻紧固件的不同紧固弧之间。
  29. 如权利要求28所述的抗反流心脏瓣膜支架，其特征在于，所述加强网包括若干相互连接的加强网结构单元，所述加强网近端一侧的加强网结构单元固定连接至第一紧固件的第二紧固弧，且所述加强网近端的另一侧的加强网结构单元固定连接至第二紧固件的第一紧固弧。
  30. 如权利要求28所述的抗反流心脏瓣膜支架，其特征在于，所述加强网包括沿着从心脏瓣膜支架远端到心脏瓣膜支架近端的方向依次设置的第一自膨胀弧、第二自膨胀弧和第三自膨胀弧；
    其中，所述第一自膨胀弧的一端与紧固件的第一紧固弧固定连接，另一端与相邻紧固件的第二紧固弧固定连接，且朝向心脏瓣膜支架远端凸起；
    其中，所述第二自膨胀弧的两端分别固定连接至所述第一自膨胀弧，且朝向心脏瓣膜支架近端凸起；
    其中，所述第三自膨胀弧的一端与紧固件的第一紧固弧固定连接，另一端与相邻紧固件的第二紧固弧固定连接，且朝向心脏瓣膜支架远端凸起；
    其中，所述第二自膨胀弧和所述第三自膨胀弧之间存在间隙。
  31. 如权利要求30所述的抗反流心脏瓣膜支架，其特征在于，当心脏瓣膜支架处于扩展状态时，紧固件的第一紧固弧与相邻紧固件的第二紧固弧形成第一圆角；第二自膨胀弧具有第二圆角，第三自膨胀弧具有第三圆角，其中第三圆角不答应第一圆角，第二圆角大于第一圆角。
  32. 如权利要求28所述的抗反流心脏瓣膜支架，其特征在于，所述加强网由曲自膨弧、联结格及第三自膨弧组成，其中所述曲自膨弧由四段组成，分别为曲臂Ⅰ、曲臂Ⅱ、曲臂Ⅲ、曲臂Ⅳ，其中曲臂Ⅰ、曲臂Ⅳ分别连接紧固弧靠近远端的0.25到0.33处，其中曲臂Ⅰ、曲臂Ⅱ的远端固定连接，且连接处与卡位端连接，其中曲臂Ⅲ、曲臂Ⅳ的远端固定连接，且连接处与卡位端连接，其中曲臂Ⅱ、曲臂Ⅲ的近端固定连接，且连接处固定连接联结格，联结格包括两个联结臂。
  33. 如权利要求32所述的抗反流心脏瓣膜支架，其特征在于，所述联结格的联结臂上设置有至少一个适于拉线穿过的联结孔。
  34. 如权利要求28所述的抗反流心脏瓣膜支架，其特征在于，所述卡位端结构单元为菱形结构，加强网远端的加强网结构单元与卡位端的一个卡位端结构单元公用一个顶点，加强网远端的加强网结构单元与紧固件的紧固弧共用一条或者两条边。
  35. 如权利要求29所述的抗反流心脏瓣膜支架，其特征在于，构成所述加强网结构单元的杆的宽度中央小两头大。
  36. 如权利要求28所述的抗反流心脏瓣膜支架，其特征在于，沿着从所述心脏瓣膜支架近端到所述心脏瓣膜支架远端的轴向方向，所述加强网依次包括相互连接的三层，第一层包括一个加强网结构单元，第二层包括两个加强网结构单元，第三层包括一个加强网结构单元；
    其中，第一层的加强网结构单元与其左边的紧固件的第二紧固弧共用一条边，且与其右边的紧固件的第一紧固弧共用一条边；
    其中，第二层左侧的加强网结构单元与其左边的紧固件的第二紧固弧共用一条边，第二层右侧的加强网结构单元与与其右边的紧固件的第一紧固弧共用一条边；
    其中，第三层的加强网结构单元与卡位端结构单元共用一个顶点。
  37. 如权利要求36所述的抗反流心脏瓣膜支架，其特征在于，加强网第二层的加强网结构单元连接区域分别沿着所述抗反流心脏瓣膜支架的周向和纵向延伸预定长度，沿着所述抗反流心脏瓣膜支架的周向方向，所述加强网结构单元连接区域包括朝向其凹陷的弯曲结构。
  38. 如权利要求28所述的抗反流心脏瓣膜支架，其特征在于，加强网的设置密度为每个紧固件对应一个加强网。
  39. 如权利要求25所述的抗反流心脏瓣膜支架，其特征在于，还包括网格状覆膜，所述网格状覆膜固定在所述抗反流心脏瓣膜支架内侧。
  40. 如权利要求39所述的抗反流心脏瓣膜支架，其特征在于，所述网格状覆膜通过与抗反流心脏瓣膜支架的各部件缝合的方式固定至所述抗反流心脏瓣膜支架。
  41. 如权利要求39所述的抗反流心脏瓣膜支架，其特征在于，所述网格状覆膜由纵线和横线编织而成，纵线与横线的角度设置为60°～90°。
  42. 如权利要求39-42中任一项所述的抗反流心脏瓣膜支架，其特征在于，还包括人工瓣叶，所述人工瓣叶包括人工瓣叶主体、耳部和紧固件，所述人工瓣叶主体的外部轮廓包括朝向该人工瓣叶凹陷的内凹区。
  43. 如权利要求42所述的抗反流心脏瓣膜支架，其特征在于，所述人工瓣叶还包括防磨边条，所述防磨边条设置在所述人工瓣叶主体的外部轮廓上。
  44. 如权利要求42所述的抗反流心脏瓣膜支架，其特征在于，所述人工瓣叶通过波浪状缝合线或者围绕缝合线的方式固定至所述抗反流心脏瓣膜支架的连接件。
PCT/CN2022/089819 2022-03-28 2022-04-28 抗反流心脏瓣膜支架 WO2023184639A1 (zh)

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