WO2022012011A1 - 一种人工心脏瓣膜 - Google Patents

一种人工心脏瓣膜 Download PDF

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Publication number
WO2022012011A1
WO2022012011A1 PCT/CN2021/072482 CN2021072482W WO2022012011A1 WO 2022012011 A1 WO2022012011 A1 WO 2022012011A1 CN 2021072482 W CN2021072482 W CN 2021072482W WO 2022012011 A1 WO2022012011 A1 WO 2022012011A1
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WO
WIPO (PCT)
Prior art keywords
anchoring frame
stent
heart valve
valve
anchoring
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2021/072482
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English (en)
French (fr)
Inventor
赵婧
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Trulive Medtech Co Ltd
Original Assignee
Shanghai Trulive Medtech Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202010680139.0A external-priority patent/CN111772879B/zh
Priority claimed from CN202021389484.0U external-priority patent/CN212395131U/zh
Application filed by Shanghai Trulive Medtech Co Ltd filed Critical Shanghai Trulive Medtech Co Ltd
Priority to EP21785740.8A priority Critical patent/EP3960129A4/en
Priority to US17/606,017 priority patent/US20220304801A1/en
Publication of WO2022012011A1 publication Critical patent/WO2022012011A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0034—D-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • the invention relates to the technical field of medical devices, in particular to a heart valve prosthesis for implantation in the heart.
  • the heart contains four chambers, the left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart.
  • the ventricular inflow tract is formed between the atrium and the ventricle, the left ventricle and the aorta form the left ventricular outflow tract, and the right ventricle and the pulmonary artery form the right ventricular outflow tract.
  • TMVR Transcatheter mitral valve replacement
  • the diameter of the native annulus of the mitral valve is larger, and accordingly, the leaflet area of the artificial valve is also larger. The larger the leaflet area, the worse the fatigue resistance.
  • the diameter of the delivery catheter is large, which increases the difficulty of delivery and the risk of vascular damage.
  • the structure of the atrioventricular valve assembly is complex. If the height of the prosthetic valve is too high, it will affect the native heart structure and heart function, touch the papillary muscle and other heart tissue abnormalities, and at the same time easily cause left ventricular outflow tract obstruction (LVOT), induce adverse postoperative effects.
  • LVOT left ventricular outflow tract obstruction
  • the tricuspid valve also suffers from high subvalvular height and right ventricular outflow tract obstruction.
  • the present invention provides an artificial heart valve, which can solve the above-mentioned defects in the prior art.
  • An artificial heart valve comprising a stent main body for supporting artificial valve leaflets, and an anchoring frame for anchoring the stent main body to the valve annulus;
  • the anchoring frame is arranged at a predetermined position close to the outflow tract side, so
  • the bracket body is disposed at a predetermined position outside the anchor frame and away from the outflow channel side, and the anchor frame is abutted against and connected to the bracket body.
  • the heart valve is implanted at the valve annulus to replace the original valve leaflets to achieve the function of opening and closing blood channels.
  • the stent body and the anchoring frame are used for supporting the leaflets and anchoring, respectively, and the radial dimension of the stent body is small, so the size of the artificial valve leaflet placed on the stent body is also smaller, improving the performance of the stent.
  • the fatigue resistance of the valve leaflet is improved; the size of the valve leaflet is reduced, so the material of the valve leaflet is also reduced accordingly; compared with the traditional double-layer stent nested inside and outside, the stent body and the anchoring frame of the present invention are connected side by side.
  • the size of the anchor frame is relatively smaller, so there is less material for the anchor frame and skirt material overlying it; the less material, the smaller the size after crimping, and the easier it is to crimp and load.
  • the prosthetic mitral valve can drive blood flow along the side wall of the ventricle, the blood can turn smoothly, creating a large vortex, which shoots blood to the aorta and then flows throughout the body.
  • the valve leaflets are located on the stent body, and the stent body is more offset to the side of the ventricular wall. , thereby promoting the recovery of ventricular function, especially in vulnerable patients with severely compromised cardiac conditions.
  • the outer peripheral side of the anchoring frame and the outer peripheral side of the bracket body abut against each other, and are connected at the abutting place. With such a structure, surface-to-surface contact can be formed between the anchor frame and the stent body, so the connection between the two is more stable.
  • the abutting part of the anchoring frame and the stent body is a single-layer structure, which can save the material of the heart valve.
  • the anchoring frame or the bracket body is a non-closed structure.
  • the non-enclosed structure can reduce the material of the anchor frame or the stent body.
  • the anchoring frame is an opening structure in the axial direction, the anchoring frame is pressed against the outer periphery of the bracket main body at the opening, and the open end of the anchoring frame is connected with the bracket main body; or the bracket main body is in the axial direction.
  • the bracket main body abuts the outer periphery of the anchoring frame at the opening, and the open end of the bracket main body is connected with the anchoring frame.
  • the opening structure arranged along the axial direction makes it possible to further reduce the material of the valve stent and the skirt material covering it without affecting the function of the anchoring frame or the main body of the stent, making it easier to crimp and hold the valve prosthesis. freed.
  • a part of the anchoring frame is an open structure
  • the part against which the bracket body abuts is a non-opening structure
  • other parts of the anchoring frame are non-opening structures
  • the The part against which the bracket body abuts is an opening structure
  • the anchoring frame has a notch structure, the notch structure is located in the outflow section of the anchoring frame, and the notch structure is configured to face the direction of the outflow channel.
  • the notched structure prevents the anchoring frame from spanning the ventricular wall, so the prosthetic heart valve does not push the ventricular wall too far against the right side of the aortic valve or the left side of the pulmonary valve.
  • the notch structure disposed in the outflow section reduces the sub-valve height of the frame portion, reducing the risk of outflow tract obstruction.
  • the valve includes artificial valve leaflets, and the valve leaflets are arranged on the main body. One end of the leaflet is connected to the body portion, and free ends of the leaflet are joined therebetween.
  • the artificial valve leaflet replaces the original valve leaflet to realize the function of opening and closing the blood channel.
  • the heart valve further includes at least one connecting ear, through which the heart valve is connected
  • the ear is connected to the delivery system; the connection ear is provided at the end of the inflow section or the end of the outflow section of the stent body, or the connection ear is provided at the end of the inflow section or the outflow section of the anchor frame. Ends.
  • the heart valve further includes a skirt for sealing.
  • the skirt is used to achieve the sealing function to ensure that the single channel of blood flows from the inflow end of the heart valve to the outflow end of the valve prosthesis, which can effectively prevent paravalvular leakage and regurgitation.
  • the stent body and the anchoring frame of the present invention are respectively used for supporting the leaflet and anchoring, and the radial dimension of the stent body is small, so the size of the artificial valve leaflet is small, and the The fatigue resistance of the valve leaflet; the size of the valve leaflet is reduced, so the valve leaflet material is also reduced; compared with the traditional double-layer stent nested inside and outside, the stent body and the anchoring frame of the present invention adopt a structure of left and right side-by-side connection, and the anchorage The size of the frame is reduced, so there is less material and skirt material to anchor the frame; less material results in a smaller size after crimping and easier crimping and loading.
  • valve leaflets are located on the stent body, and the stent body is more offset to the side of the ventricular wall, and the blood flow tends to flow along the ventricular side wall, which is more beneficial to maintain the natural "blood flow of the left atrium.” vortex", thereby promoting the recovery of ventricular function, especially in vulnerable patients with severely compromised cardiac conditions.
  • the stent body and the anchoring frame of the present invention adopt the structure of left and right side-by-side connection, so that surface-to-surface contact is formed between the stent body and the anchoring frame, so the connection between the two is more stable.
  • the anchoring frame of the present invention is also configured with a notch structure.
  • the notch structure faces the outflow tract, the notch structure prevents the anchoring frame from crossing the ventricular wall, so the artificial heart valve will not make the ventricular wall abut against the aortic valve too much.
  • the right side or the left side of the pulmonary valve can reduce the influence of the artificial heart valve body on the heart function; when the anchoring frame is a non-closed structure along the axial direction, the opening structure arranged along the axial direction does not affect the anchoring frame or the main body of the stent.
  • the material of the valve stent and the skirt material covering it can be further reduced, making it easier to hold and release the valve prosthesis.
  • Fig. 1 is the partial structural representation of the artificial heart valve of embodiment 1 of the present invention
  • FIG. 2 is a schematic plan view of the artificial heart valve according to Embodiment 1 of the present invention.
  • FIG. 3 is a schematic perspective view of the artificial heart valve of Embodiment 1 of the present invention.
  • FIG. 4 is a schematic structural diagram of the anchoring frame of Embodiment 1 of the present invention.
  • Fig. 5 is the top-view structure schematic diagram of the anchoring frame of Embodiment 1 of the present invention.
  • FIG. 6 is another schematic perspective view of the artificial heart valve of Embodiment 1 of the present invention.
  • FIG. 7 is another structural schematic diagram of the anchoring frame of Embodiment 1 of the present invention.
  • FIG. 8 is a schematic structural diagram of a stent body according to Embodiment 1 of the present invention.
  • FIG. 9 is a schematic top view of the stent body according to Embodiment 1 of the present invention.
  • FIG. 10 is a schematic structural diagram of another stent body according to Embodiment 1 of the present invention.
  • FIG. 11 is a schematic top view of another bracket body according to Embodiment 1 of the present invention.
  • FIG. 12 is a schematic diagram of the implantation of the artificial heart valve in the heart of Embodiment 1 of the present invention.
  • FIG. 13 is a schematic diagram of the artificial heart valve of Embodiment 3 of the present invention.
  • FIG. 14 is a schematic diagram of another artificial heart valve according to Embodiment 3 of the present invention.
  • FIG. 15 is a schematic diagram of yet another artificial heart valve according to Embodiment 3 of the present invention.
  • FIG. 16 is a schematic perspective view of an artificial heart valve of Embodiment 4 of the present invention.
  • Bracket main body 110 main body inflow section 111; main body transition section 112; main body outflow section 113; hanging lug 114; anchoring frame 210; inflow section 211; transition section 212; 215; notch structure 216; frame open end 300; main body open end 301.
  • proximal end and distal end are used as orientation terms, wherein “proximal end” refers to the end close to the apex of the heart during the operation; “distal end” refers to the end away from the apex of the heart.
  • proximal end refers to the end close to the apex of the heart during the operation; “distal end” refers to the end away from the apex of the heart.
  • Heart valve and “artificial heart valve” have the same meaning.
  • the "outflow tract” refers to the left ventricular outflow tract
  • the "outflow tract” refers to the right ventricular outflow tract.
  • “circular-like” refers to hexagons and polygons with more than six sides whose nature is close to a circle
  • “flower-shaped” refers to the shape of the outer edge of a petal. As described herein, square includes rectangles and squares.
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • installed should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • FIGS. 1-12 are schematic diagrams of the heart valve in this embodiment, wherein the heart valve includes a stent body 110 for supporting the artificial valve leaflets, and The stent main body 110 is anchored to the anchoring frame 210 at the valve annulus; the anchoring frame 210 is arranged at a predetermined position close to the left ventricular outflow tract, the stent main body 110 is arranged at a predetermined position outside the anchoring frame 210 and away from the left ventricular outflow tract, the anchoring frame 210 abuts against and connects with the bracket body 110 .
  • the stent main body 110 is provided with at least two artificial valve leaflets, the number of artificial valve leaflets may be the same as or different from the original valve leaflets, and each valve leaflet is arranged along the circumference of the stent main body 110 .
  • the leaflets can be fixed to the stent body 110 by direct connection or indirect connection, with the free ends of the leaflets engaged with each other.
  • the material of the valve leaflet is animal pericardium or polymer material, animal pericardium such as pig pericardium, bovine pericardium, and polymer material such as PET or PTFE.
  • the number of artificial valve leaflets and the valve leaflet material can be set according to actual clinical needs, which will not be repeated here.
  • the stent body 110 and the anchoring frame 210 are connected side by side.
  • the stent body 110 and the anchoring frame 210 are used for supporting the leaflets and anchoring, respectively.
  • the radial direction of the stent body 110 The size is smaller, so the size of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved; the size of the valve leaflet is reduced, so the material of the valve leaflet is reduced.
  • the anchor frame 210 and the skirt have less material, the less material, the smaller the size after crimping, and the easier crimping and loading.
  • the prosthetic mitral valve can drive blood flow along the side wall of the ventricle, the blood can turn smoothly, creating a large vortex, which shoots blood to the aorta and then flows throughout the body.
  • the valve leaflets are located on the stent body, and the stent body is more offset to the side of the ventricular wall. , thereby promoting the recovery of ventricular function, especially in vulnerable patients with severely compromised cardiac conditions.
  • the outer peripheral side of the anchoring frame 210 and the outer peripheral side of the bracket main body 110 abut against each other and are connected at the abutting place 215 . Referring to FIG. 1 , FIG. 2 , FIG. 3 , and FIG.
  • FIG. 3 and FIG. 6 are schematic perspective views of the artificial heart valve, respectively.
  • the stent body 110 is a cylinder
  • the anchoring frame 210 and the stent body 110 form abutment from the distal edge to the proximal end edge, and are connected at the abutting position 215 .
  • a surface-to-surface contact is formed between the bracket body 110 and the anchor frame 210, so the connection between the two is more stable.
  • the bracket body 110 and the anchoring frame 210 can also be abutted and connected at a predetermined position between the two ends.
  • the abutting area and abutting area between the bracket main body 110 and the anchoring frame 210 , and the connection site between the bracket main body 110 and the anchoring frame 210 should be selected according to actual needs, and are not used to limit the protection scope of the present invention.
  • the anchoring frame 210 includes an inflow section 211, a transition section 212, and an outflow section 213.
  • the inflow section 211 is fixed in the left atrium
  • the transition section 212 is fixed at the valve annulus
  • the outflow section 213 extends into the left ventricle.
  • the outflow segment 213 is configured to extend away from the left ventricular outflow tract.
  • the outflow section 213 of the anchoring frame 210 gradually moves away from the left ventricular outflow tract, which can reduce the influence of the heart valve of this embodiment on the heart function and prevent conduction block.
  • the distance between the outflow segment 213 and the axis of the stent body 110 is R, wherein from the distal end to the proximal end, R gradually decreases in a linear manner, as shown in Fig. 6, the outflow section 213 is a slope at this time.
  • R can also be selected to gradually decrease in a non-linear manner, such as a curved surface, which can also reduce the risk of left ventricular outflow tract obstruction.
  • the included angle between the tangent line of the outflow segment 213 and the axial direction is ⁇ , and ⁇ is an acute angle. If the included angle ⁇ is too small, the degree of deviation of the outflow section 213 from the outflow tract is too small, increasing the risk of outflow tract obstruction. If the included angle ⁇ is too large, the resistance of the crimping will increase, so the included angle ⁇ is preferably 30° ⁇ 60° range.
  • the stent main body 110 in this embodiment is a cylinder, including a main body inflow section 111 , a main main body transition section 112 and a main main body outflow section 113 .
  • the bracket body 110 may also be an elliptical cylinder (as shown in FIG. 10 ), a cone, or a combined structure of a cylinder and a vertebral body.
  • the cross section of the bracket main body 110 is a circle (as shown in FIG. 9 ).
  • the cross section of the bracket main body 110 can also be configured as a circular shape, a D shape, a flower shape, or a combination of structure. As shown in FIG. 11 , the cross section of the bracket body 110 is flower-shaped.
  • the bracket main body 110 is a mesh structure composed of multiple rows of units.
  • the constituent units in this embodiment are rhombus structures, and the rhombus mesh surface has the advantages of a simple forming process and a flatter mesh surface.
  • the constituent units may also be triangular, square, pentagonal, teardrop-shaped, or other mesh units that can form a closed shape.
  • the stent body 110 is used to fix the valve leaflets, so its specific shape and the shape of its constituent units can be selected according to actual needs, and are not used to limit the protection scope of the present invention.
  • the proximal end of the main body outflow section 113 of the stent body 110 is also provided with a hanging ear 114, and the hanging ear 114 is used to connect with the delivery system to ensure that the heart valve is loaded into the delivery system, the valve is released from the delivery system and The valve's position relative to the delivery system remains unchanged during delivery.
  • the hanging ears 114 may also be provided at the distal end of the main body inflow section 111 , or at both ends of the stent body 110 at the same time.
  • the stent body 110 should have a certain elastic deformation ability, and be crimped in the delivery system during delivery.
  • the stent body 110 in this embodiment is manufactured by cutting a nickel-titanium alloy pipe, the outer diameter of the pipe is 5-15 mm, and the diameter size after shaping is selected according to actual needs.
  • the material of the stent body 110 also includes an elastically or plastically deformable material, such as balloon-expandable, or may be shaped to transition between a contracted delivery state and an expanded deployed state in response to temperature changes memory alloy.
  • the stent body 110 can be made of Nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum-chromium, or other biocompatible metals known to those skilled in the art become.
  • the outer peripheral side of the anchoring frame 210 can be pre-configured to have the same curvature as the outer peripheral side of the bracket body 110 , that is, a structure in which part of the peripheral side is recessed toward the center, It is then fixed to the outer periphery of the stent body 1 .
  • the anchoring frame 210 is a cylinder, and the anchoring frame 210 is connected to the outer peripheral side of the bracket main body 110 . After the connection is completed, the bracket main body 110 and the anchoring frame 210 form a mutually abutting structure.
  • the anchoring frame 210 may be configured as a cylinder, an elliptical cylinder, a cone, or a combination of cylinders and cones.
  • the cross-sectional shape of the anchor frame 210 may be circular, D-shaped, quasi-circular, flower-shaped, or other irregular shapes, or a combination of these shapes.
  • the anchoring frame 210 is a mesh structure composed of multiple rows of units, and in this embodiment, the units are diamond-shaped units. Of course, in other embodiments, the cells may also be triangular, square, pentagonal, quasi-circular, drop-shaped, etc., which can form a closed-shaped grid cell.
  • the shape of the anchoring frame 210, the shape, quantity, and arrangement of the units should be selected according to actual needs, and are not limited here.
  • the proximal end of the outflow section 213 of the anchoring frame 210 is further provided with a fixing ear 214, and the fixing ear 214 is used for connecting with the delivery system to ensure that the heart valve is loaded into the delivery system, and the valve is released from the delivery system and the valve.
  • the relative position to the conveying system remains unchanged during the conveying process.
  • the fixing ears 214 may also be provided at the distal end of the inflow section 211 , or at both ends of the anchoring frame 210 at the same time.
  • the stiffness of the anchoring frame 210 should be less than the stiffness of the stent body 110 .
  • the anchoring frame 210 of this embodiment is woven from a nickel-titanium alloy, and the weaving process enables the anchoring frame 210 to have better deformability, and is easy to be crimped and transported.
  • the anchoring frame 210 may also employ elastically or plastically deformable materials, such as balloon-expandable, or may be responsive to temperature changes to transition between a contracted delivery state and an expanded deployed state shape memory alloys.
  • connection between the bracket main body 110 and the anchoring frame 210 is performed at the contact point, specifically, riveting, welding, snapping, and suturing can be used for connection, and an appropriate connection can be selected according to the materials of the bracket main body 110 and the anchoring frame 210 Way.
  • the heart valve of this embodiment further includes a skirt for sealing.
  • the skirt can be arranged on the inner surface, outer surface, or both of the inner and outer surfaces of the bracket body 110, or arranged on the inner surface, outer surface, or both of the inner and outer surfaces of the anchor frame 210.
  • the skirt is used to achieve the sealing function to ensure that the single channel of blood flows from the inflow end of the heart valve to the outflow end of the valve prosthesis, which can effectively prevent paravalvular leakage and regurgitation.
  • the material of the skirt is animal pericardium or biocompatible polymer material, animal pericardium such as pig pericardium and bovine pericardium, and biocompatible polymer material such as PET and PTFE.
  • the area, layout area and material of the skirt should be set according to the actual clinical needs, which is not limited here.
  • the anchoring form of the valve prosthesis is not limited. Flanges may be provided on the stent main body 110 and the anchoring frame 210, and an Oversize anchoring form may be used; the stent main body 110 and the anchoring frame 210 may also be provided with thorns, anchoring claws, etc.
  • the structure grabs the native tissue, and can also be fixed by anchoring the tether to the ventricular wall, or using a combination of various methods for anchoring.
  • This embodiment provides a tricuspid valve artificial heart valve.
  • the structure of the heart valve in this embodiment is similar to that of Embodiment 1, except that the stent body 110 of this embodiment is implanted in the valve annulus in the right ventricular inflow tract
  • the anchoring frame 210 is fixed at a predetermined position near the right ventricular outflow tract.
  • the outflow segment 213 is positioned gradually away from the RV outflow tract, thereby reducing the risk of RV outflow tract obstruction.
  • This embodiment provides an artificial heart valve, which is an improvement on the basis of Embodiment 1 or Embodiment 2, wherein the abutment 215 of the anchoring frame 210 and the stent body 110 is a single-layer structure.
  • FIG. 13 is a schematic diagram of the artificial heart valve of this embodiment, wherein the anchoring frame 210 is a non-closed structure. That is, the anchoring frame 210 is an open structure along the axial direction, and its cross-section is C-shaped. The opening end of the anchoring frame 210 in the axial direction is the frame opening end 300, and the frame opening end 300 abuts against the outer periphery of the bracket body 110, and connect.
  • FIG. 14 is a schematic diagram of the artificial heart valve of this embodiment, wherein the stent body 110 is a non-closed structure, the stent body 110 is an opening structure along the axial direction, and its cross section is C
  • the open end of the bracket main body 110 is the main body open end 301, and the main body open end 301 abuts the outer periphery of the anchoring frame 210 and is connected.
  • a part of the anchoring frame 210 is a non-closed structure, and the part against which the bracket body 110 abuts is a closed structure, and the other part of the anchoring frame 210 is a closed structure, The part against which the bracket body 110 abuts is a non-closed structure.
  • the anchoring frame 210 is opened at a predetermined position at the proximal end and is opened at a predetermined position at the distal end of the stent body 110 , wherein the frame open end 300 abuts the stent body 110, the open end 301 of the main body abuts the outer periphery of the anchoring frame 210, so that the abutment 215 is a single-layer structure.
  • the opening structure arranged in the axial direction makes it possible to further reduce the material of the valve stent and the skirt material covering it without affecting the function of the anchoring frame 210 or the stent body 110, which is easier to compress the valve prosthesis. Grip and release.
  • This embodiment provides an artificial heart valve, which is an improvement on the basis of Embodiment 1, Embodiment 2 or Embodiment 3, wherein a gap structure 216 is configured on the outflow section of the anchoring frame 210, see FIG. 16 .
  • the notch structure 216 is arranged toward the outflow channel side.
  • the notched structure 216 prevents the anchoring frame from spanning the ventricular wall, so the artificial heart valve does not make the ventricular wall too much against the right side of the aortic valve or the left side of the pulmonary valve, which can reduce the impact of the artificial heart valve body on cardiac function.
  • the notch structure 216 reduces the subvalvular height of the outflow segment 213, thereby reducing the risk of outflow tract obstruction.
  • the shape and area of the notch structure 216 should be configured according to clinical needs, and are not used to limit the protection scope of the present invention.

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Abstract

一种人工心脏瓣膜，包括支撑人工瓣叶的支架主体（110）及将支架主体（110）锚固至瓣环处的锚固框架（210）；锚固框架（210）配置在靠近流出道侧的预定位置处，支架主体（110）配置在锚固框架（210）外且远离流出道侧的预定位置处，锚固框架（210）与支架主体（110）相抵靠且连接。相对于单层支架，支架主体（110）与锚固框架（210）分别用于支撑瓣叶以及锚固，支架主体（110）的径向尺寸较小，所以人工瓣叶的尺寸也较小，提高了瓣叶的耐疲劳性能；瓣叶的尺寸变小了，所以瓣叶材料也相应减少；相对于内外嵌套的双层支架，锚固框架（210）的尺寸减小，因此锚固框架（210）的材料和裙边材料更少；材料越少，压握后尺寸越小，且越容易压握和装载。

Description

一种人工心脏瓣膜 技术领域
本发明涉及医疗器械技术领域，具体涉及一种用于植入心脏内的心脏瓣膜假体。
背景技术
心脏含有四个心腔，左心房与左心室位于心脏左侧，右心房与右心室位于心脏右侧。心房与心室间形成心室流入道，左心室与主动脉形成左室流出道，右心室与肺动脉形成右室流出道。在室流入道和室流出道处存在具有“单向阀”功能的瓣膜，保证心腔内血液的正常流动。当该瓣膜出现问题时，心脏血液动力学改变，心脏功能异常，称为瓣膜性心脏病。
二尖瓣返流会导致心肌重构，心室进行性扩大，最终导致心力衰竭。经导管二尖瓣置换手术(TMVR)采用导管介入的方法，将人工瓣膜在体外压缩到输送系统，送达人体二尖瓣瓣环处，并将人工瓣膜释放固定在二尖瓣瓣环处替换原生瓣膜。与外科手术相比，TMVR无须体外循环辅助装置，创伤小、病人恢复快，术后患者血流动力学指标可以得到明显改善。
虽然二尖瓣瓣膜置换技术飞速发展，但是在瓣膜的设计上仍存在一些公认的难题，比如：
1、相较于主动脉瓣，二尖瓣的原生瓣环直径较大，相应地，人工瓣膜的瓣叶面积也要很大。瓣叶面积越大，耐疲劳性能越差。
2、针对现有二尖瓣瓣膜假体，输送导管的直径很大，增加了输送的难度和血管损伤的风险。
3、房室瓣组合体结构复杂，如果假体瓣膜瓣下高度过高会影响原生心脏结构与心脏功能，触碰乳头肌等心脏组织异常，同时易引起左室流出道阻塞(LVOT)，诱发不良的术后影响。
三尖瓣膜同样存在瓣膜瓣下高度过高和右室流出道阻塞的问题。
发明内容
本发明提供了一种人工心脏瓣膜，可以解决现有技术中的上述缺陷。
本发明的技术方案如下：
一种人工心脏瓣膜，包括用于支撑人工瓣叶的支架主体，及用于将所述支架主体锚固至瓣环处的锚固框架；所述锚固框架配置在靠近流出道侧的预定位置处，所述支架主体配置在所述锚固框架外且远离所述流出道侧的预定位置处，所述锚固框架与所述支架主体相抵靠且连接。
心脏瓣膜植入瓣环处，用于替代原生瓣叶实现开启和关闭血液通道的功能。相对于现有的单层支架，采用支架主体与锚固框架分别用于支撑瓣叶以及锚固，支架主体的径向尺寸较小，所以置于支架主体上的人工瓣叶的尺寸也较小，提高了瓣叶的耐疲劳性能；瓣叶的尺寸变小了，所以瓣叶材料也相应减少；相对于传统内外嵌套的双层支架，本发明的支架主体与锚固框架为左右并列连接的结构，锚固框架的尺寸相对更小，因此锚固框架的材料和覆于其上的裙边材料更少；材料越少，压握后尺寸越小，且越容易压握和装载。
研究表明，若人工二尖瓣瓣膜能够驱动血液沿着心室侧壁流动，血液可以平稳转弯，产生一个很大的涡流，从而将血液射向主动脉，继而流向全身。左右结构的心脏瓣膜，瓣叶位于支架主体上，而支架主体向心室壁一侧偏移较多，血流会倾向于沿着心室侧壁流动，更有益于保持左心房自然“血流漩涡”，从而促进心室功能的恢复，尤其是在心脏状况严重受损的脆弱患者中。较佳的，所述锚固框架的外周侧与所述支架主体外周侧相互抵靠，且在抵靠处连接。这样的结构，锚固框架与支架主体之间可以形成面-面接触，因此两者之间的连接更加稳固。
较佳的，所述锚固框架与所述支架主体的抵靠处为单层结构，可以节省心脏瓣膜的材料。
较佳的，所述锚固框架或所述支架主体为一非封闭结构。非封闭结构能够减少锚固框架或所述支架主体的材料。
较佳的，所述锚固框架沿轴向为一开口结构，锚固框架在开口处抵至支架主体外周，所述锚固框架的开口端与所述支架主体连接；或所述支架主体沿轴向为一开口结构，支架主体在开口处抵至锚固框架外周，所述支架主体的开口端与所述锚固框架连接。沿轴向设置的开口结构，使得在不影响锚固框架或支架主体的功能的前提下，能够进一步减少瓣膜支架的材料，以及覆于其上的裙边材料，更易于瓣膜假体的压握和释放。
较佳地，在抵靠处，所述锚固框架的一部分为开口结构，所述支架主体与之抵靠的部分为非开口结构，同时所述锚固框架的其它部分为非开口结构，而所述支架主体与之抵靠的部分为开口结构。
较佳的，所述锚固框架具有一缺口结构，所述缺口结构位于所述锚固框架的流出段，且所述缺口结构配置为朝向流出道的方向。缺口结构使得锚固框架不会跨越心室壁面，因此人工心脏瓣膜不会使心室壁过于抵靠在主动脉瓣的右侧或肺动脉瓣左侧。同时，配置在流出段的缺口结构减小了框架部的瓣下高度，降低了流出道阻塞的风险。
优选的，所述瓣膜包括人工瓣叶，瓣叶布设在主体部。所述瓣叶一端连接至所述主体部，瓣叶的自由端之间接合。
瓣膜在工作状态下，由人工瓣叶替代原生瓣叶实现开启和关闭血液通道的功能。
为了防止心脏瓣膜在输送系统中发生相对移动，使其在运送过程中顺利的植入预定位置，并完成脱离、释放，所述心脏瓣膜还包括至少一连接耳，所述心脏瓣膜通过所述连接耳与输送系统相连；所述连接耳设于所述支架主体的流入段的端部或流出段的端部，或所述连接耳设于所述锚固框架的流入段的端部或流出段的端部。
较佳的，所述心脏瓣膜还包括用于密封的裙边。裙边用于实现密封功能，保证血液的单一通道为自心脏瓣膜的流入道端流向瓣膜假体的流出道端，能够有效防止瓣周漏以及反流。
与现有技术相比，本发明的有益效果如下：
第一，相对于现有单层支架的结构，本发明的支架主体与锚固框架分别用于支撑瓣叶以及锚固，支架主体的径向尺寸较小，所以人工瓣叶的尺寸较小，提高了瓣叶的耐疲劳性能；瓣叶的尺寸变小了，所以瓣叶材料也减少了；相对于传统内外嵌套的双层支架，本发明的支架主体与锚固框架采用左右并列连接的结构，锚固框架的尺寸减小了，因此锚固框架的材料和裙边材料更少；材料越少，压握后尺寸越小，且越容易压握和装载。此外，左右结构的心脏瓣膜，瓣叶位于支架主体上，而支架主体向心室壁一侧偏移较多，血流会倾向于沿着心室侧壁流动，更有益于保持左心房自然“血流漩涡”，从而促进心室功能的恢复，尤其是在心脏状况严重受损的脆弱患者中。
第二，本发明的支架主体与锚固框架采用左右并列连接的结构，使支架主体、锚固框架之间形成面-面接触，因此两者之间的连接更加稳固。
第三，本发明的锚固框架还配置有缺口结构，当缺口结构朝向流出道时，缺口结构使得锚固框架不会跨越心室壁面，因此人工心脏瓣膜不会使心室壁过于抵靠在主动脉瓣的右侧或肺动脉瓣左侧，能够降低人工心脏瓣膜体对心脏功能的影响；当锚固框架沿轴向为一非封闭结构时，沿轴向设置的开口结构，使得在不影响锚固框架或支架主体的功能的前提下，能够进一步减少瓣膜支架的材料，以及覆于其上的裙边材料，更易于瓣膜假体的压握和释放。
当然，实施本发明的任一产品并不一定需要同时达到以上所述的所有优点。
附图说明
图1是本发明实施例1的人工心脏瓣膜的部分结构示意图；
图2是本发明实施例1的人工心脏瓣膜的俯视示意图；
图3是本发明实施例1的人工心脏瓣膜的示意性透视图；
图4是本发明实施例1的锚固框架的结构示意图；
图5是本发明实施例1的锚固框架的俯视结构示意图；
图6是本发明实施例1的人工心脏瓣膜的另一示意性透视图；
图7是本发明实施例1的锚固框架的另一结构示意图；
图8是本发明实施例1的支架主体的结构示意图；
图9是本发明实施例1的支架主体的俯视示意图；
图10是本发明实施例1的另一支架主体的结构示意图；
图11是本发明实施例1的又一支架主体的俯视示意图；
图12是本发明实施例1的人工心脏瓣膜植入心脏内的示意图；
图13是本发明实施例3的人工心脏瓣膜的示意图；
图14是本发明实施例3的另一人工心脏瓣膜的示意图；
图15是本发明实施例3的又一人工心脏瓣膜的示意图；
图16是本发明实施例4的人工心脏瓣膜的示意性透视图。
附图标记：支架主体110；主体流入段111；主体过渡段112；主体流出段113；挂耳114；锚固框架210；流入段211；过渡段212；流出段213；固定耳214；抵靠处215；缺口结构216；框架开口端300；主体开口端301。
具体实施方式
为了更加清楚地描述本发明的结构特征，采用“近端”、“远端”作为方位词，其中“近端”表示在手术过程中靠近心尖的一端；“远端”表示远离心尖的一端。“心脏瓣膜”和“人工心脏瓣膜”具有相同的含义。
如本文所述的，当人工心脏瓣膜为二尖瓣膜时，“流出道”指的是左室流出道，当人工心脏瓣膜为三尖瓣膜时，“流出道”指的是右室流出道。如本文所述的，“类圆形”指的是六边形及边数在六以上的多边形，其性质接近于圆，“花形”指的是花瓣外边缘的形状。如本文所述的，方形包括长方形和正方形。
在本发明的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所述的方位或位置关系，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”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
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，可以是固定连接，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，可以具体情况理解上述术语在本发明中的具体含义。
在本发明的描述中，需要说明的是，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。
下面结合具体实施例，进一步阐述本发明。应该理解，这些实施例仅用于说明本发明，而不用于限定本发明的保护范围。在实际应用中本领域技术人员根据本发明做出的改进和调整，仍属于本发明的保护范围。
实施例1
本实施例提供一种二尖瓣人工心脏瓣膜，参见图1-图12，为本实施例的心脏瓣膜的示意图，其中，心脏瓣膜包括用于支撑人工瓣叶的支架主体110，及用于将支架主体110锚固至瓣环处的锚固框架210；锚固框架210配置在靠近左室流出道的预定位置处，支架主体110配置在锚固框架210外且远离左室流出道的预定位置处，锚固框架210与支架主体110相抵靠且连接。
支架主体110内配置有至少两片人工瓣叶，人工瓣叶的数量可以与原生瓣叶相同或者不同，每一瓣叶沿支架主体110的周向布置。瓣叶可以通过直接连接或间接连接的方式固定至支架主体110，瓣叶的自由端之间相互接合。瓣叶的材料为动物心包或高分子材料，动物心包如猪心包、牛心包，高分子材料如PET或PTFE。人工瓣叶的数量、瓣叶材料可以根据实际临床需要进行设置，此处不再赘述。
本实施例中，支架主体110与锚固框架210为左右并列连接的结构，相对于现有的单层支架，支架主体110与锚固框架210分别用于支撑瓣叶以及锚固，支架主体110的径向尺寸较小，所以人工瓣叶的尺寸较小，提高了瓣 叶的耐疲劳性能；瓣叶的尺寸变小了，所以瓣叶材料减少。相对于传统内外嵌套的双层支架，锚固框架210和裙边材料更少，材料越少，压握后尺寸越小，且越容易压握和装载。
研究表明，若人工二尖瓣瓣膜能够驱动血液沿着心室侧壁流动，血液可以平稳转弯，产生一个很大的涡流，从而将血液射向主动脉，继而流向全身。左右结构的心脏瓣膜，瓣叶位于支架主体上，而支架主体向心室壁一侧偏移较多，血流会倾向于沿着心室侧壁流动，更有益于保持左心房自然“血流漩涡”，从而促进心室功能的恢复，尤其是在心脏状况严重受损的脆弱患者中。本实施例中，锚固框架210的外周侧与支架主体110外周侧相互抵靠并且在抵靠处215进行连接。参见图1、图2、图3、图6，其中，图3、图6分别为人工心脏瓣膜的示意性透视图。支架主体110为一圆柱体，锚固框架210与支架主体110自远端边缘至近端边缘之间形成抵靠，并在抵靠处215进行连接。支架主体110与锚固框架210之间形成面-面接触，因此两者之间的连接会更加稳固。当然，在其他实施例中，支架主体110与锚固框架210也可以在两个端部之间的预定位置处抵靠连接。支架主体110与锚固框架210之间抵靠的区域、抵靠面积，支架主体110与锚固框架210之间的连接位点应该根据实际需求进行选择，并不用于限制本发明的保护范围。
锚固框架210包括流入段211、过渡段212和流出段213，流入段211固定在左心房内，过渡段212固定在瓣环处，流出段213延伸至左心室内。
继续参见图1、图2、图4、图6、图7，在一个优选实施例中，在靠近左室流出道一侧，流出段213被构造为远离左室流出道的方向延伸。当心脏瓣膜植入后，锚固框架210的流出段213逐渐远离左室流出道，能够降低本实施例的心脏瓣膜对心脏功能的影响，防止传导阻滞。
本实施例中，在靠近左室流出道一侧，流出段213与支架主体110轴心之间的距离为R，其中，自远端至近端，R以线性的方式逐渐减小，如图6所示，此时流出段213为一斜坡面。当然，在其他实施例中，R还可以选择以非线性的方式逐渐减小，如弧形面，同样能够实现降低左室流出道阻塞的风险。
继续参见图7，靠近左室流出道一侧，流出段213的切线与轴向的夹角为α，α为锐角。若夹角α太小，则流出段213偏离流出道的程度太小，增大流出道阻塞的风险，若夹角α太大，则会增加压握的阻力，因此夹角α优选在30°～60°范围内。
参见图8，本实施例中的支架主体110为一圆柱体，包括主体流入段111、主体过渡段112和主体流出段113。当然，在其他实施例中，支架主体110还可以为一椭圆柱体(如图10所示)、圆锥体，还可以是柱体和椎体的组合结构。本实施例中，支架主体110的横截面为一圆形(如图9所示)，在其他实施例中，支架主体110的横截面还可以配置为类圆形、D形或花形，或组合结构。如图11所示，支架主体110的横截面为花形。
支架主体110为由多排单元组成的网状结构，本实施例的组成单元为菱形结构，菱形网面具有成型工艺简单，网面更加平整的优点。在其他替换实施例中，所述组成单元还可以为三角形、方形、五边形、水滴形等可形成封闭形状的网格单元。支架主体110用于固定瓣叶，因此其具体的形状、组成单元的形状可以根据实际需求进行选择，并不用于限制本发明的保护范围。
继续参见图8、图10，支架主体110的主体流出段113的近端还设置有挂耳114，挂耳114用于与输送系统相连，保证心脏瓣膜装载进入输送系统、瓣膜释放脱离输送系统及瓣膜在输送过程中与输送系统的相对位置不变。当然，在其他实施例中，挂耳114还可以设于主体流入段111的远端，或同时设于支架主体110的两个端部。
由于心脏瓣膜需经输送系统植入体内，因此支架主体110应具有一定的弹性形变能力，输送时被压握在输送系统内。本实施例的支架主体110采用镍钛合金管材切割制造，管材外径为5～15mm，根据实际需要选取定型后的直径尺寸。在其他实施例中，支架主体110的材料还包括可弹性或可塑性变形的材料，如球囊可扩张的，或者可以是响应温度变化以在收缩的递送状态和扩张的展开状态之间转变的形状记忆合金。具体的，支架主体110可以采用如镍钛诺、钛合金、钴铬合金、MP35n、316不锈钢、L605、Phynox/Elgiloy、铂铬，或如本领域技术人员已知的其它生物相容性金属制成。
继续参见图4，为本实施例的锚固框架210的结构示意图，锚固框架210的外周侧可以预先配置为与支架主体110外周侧相同的曲率，即构造为部分周侧向中心处凹陷的结构，再固定至支架主体1外周。
在一个可选实施例中，锚固框架210为一柱体，锚固框架210与支架主体110外周侧连接，连接完成后，支架主体110与锚固框架210形成相互抵靠的结构。锚固框架210可以配置为圆柱体、椭圆柱体、圆锥体，或者柱体与椎体的组合。锚固框架210的横截面形状可以为圆形、D形、类圆形、花形或其他不规则形状，或者这些形状的组合。
锚固框架210为由多排单元组成的网状结构，本实施例中，所述单元为菱形单元。当然，在其他实施例中，所述单元还可为三角形、方形、五边形、类圆形、水滴形等可形成封闭形状的网格单元。锚固框架210的形状、单元的形状、数量、排列方式应根据实际需要进行选择，此处不再限制。
在另一可选实施例中，锚固框架210的流出段213近端还设置有固定耳214，固定耳214用于与输送系统相连，保证心脏瓣膜装载进入输送系统、瓣膜释放脱离输送系统及瓣膜在输送过程中与输送系统的相对位置不变。当然，在其他实施例中，固定耳214还可以设于流入段211的远端，或同时设于锚固框架210的两个端部。
由于心脏瓣膜压握入输送系统进行输送，锚固框架210的刚度应小于支架主体110的刚度。优选地，本实施例的锚固框架210采用镍钛合金编织而成，编织工艺使锚固框架210具有较好的形变能力，易于压握和输送。当然，在其他实施例中，锚固框架210还可以也采用可弹性或可塑性变形的材料，如球囊可扩张的，或者可以是响应温度变化以在收缩的递送状态和扩张的展开状态之间转变的形状记忆合金。如采用如镍钛诺、钛合金、钴铬合金、MP35n、316不锈钢、L605、Phynox/Elgiloy、铂铬，或如本领域技术人员已知的其它生物相容性金属制成。
本实施例中，支架主体110、锚固框架210的接触位点处进行连接，具体可以采用铆接、焊接、卡扣、缝合的方式连接，可以根据支架主体110、锚固框架210的材料选择合适的连接方式。
进一步的，本实施例的心脏瓣膜还包括用于密封的裙边。裙边可以布设于支架主体110的内表面、外表面，或者内外表面同时布设，或布设于锚固框架210的内表面、外表面，或者内外表面同时布设。裙边用于实现密封功能，保证血液的单一通道为自心脏瓣膜的流入道端流向瓣膜假体的流出道端，能够有效防止瓣周漏以及反流。其中，裙边的材料为动物心包或生物相容性高分子材料，动物心包如猪心包、牛心包，生物相容性高分子材料如PET、PTFE。裙边布设的区域、布设面积以及材料应根据实际的临床需求进行设置，此处不再限制。
本实施例中不限定瓣膜假体的锚固形式，可以在支架主体110、锚固框架210上设置法兰，采用Oversize的锚固形式；也可以在支架主体110、锚固框架210设置刺、锚爪等锚固结构对原生组织进行抓取，还可以采取系绳锚固到心室壁的方式进行固定，或者采用多种方式组合的形式进行锚固。
实施例2
本实施例提供一种三尖瓣人工心脏瓣膜，本实施例的心脏瓣膜的结构与实施例1的类似，不同之处在于，本实施例的支架主体110植入在右室流入道内的瓣环处，锚固框架210固定在靠近右室流出道的预定位置处。
为了降低心脏瓣膜对右室流出道的影响，流出段213设置为逐渐远离右室流出道，从而降低右室流出道阻塞的风险。
实施例3
本实施例提供一种人工心脏瓣膜，是在实施例1或实施例2的基础上做的改进，其中，锚固框架210与支架主体110的抵靠处215为单层结构。
在一个实施例中，参见图13，为本实施例的人工心脏瓣膜的示意图，其中，锚固框架210为非封闭结构。即锚固框架210沿轴向方向为一开口结构，其横截面为C形，锚固框架210的沿轴向的开口端为框架开口端300，框架开口端300抵靠至支架主体110的外周，并连接。
在另一实施例中，参见图14，为本实施例的人工心脏瓣膜的示意图，其中，支架主体110为一非封闭结构，支架主体110沿轴向方向为一开口结构， 其横截面为C形，支架主体110的开口端为主体开口端301，主体开口端301抵至锚固框架210外周，并连接。
在另一可选实施例中，在抵靠处215，锚固框架210的一部分为非封闭结构，而支架主体110与之抵靠的部分为封闭结构，且锚固框架210的其它一部分为封闭结构，而支架主体110与之抵靠的部分为非封闭结构。参见图15，为本实施例的心脏瓣膜的示意性透视图，锚固框架210的近端的预定位置处开口，支架主体110远端的预定位置处开口，其中，框架开口端300抵至支架主体110外周，主体开口端301抵至锚固框架210外周，从而使抵靠处215为单层结构。
沿轴向设置的开口结构，使得在不影响锚固框架210或支架主体110的功能的前提下，能够进一步减少瓣膜支架的材料，以及覆于其上的裙边材料，更易于瓣膜假体的压握和释放。
实施例4
本实施例提供一种人工心脏瓣膜，是在实施例1、实施例2或实施例3的基础上做的改进，其中，锚固框架210的流出段配置有一缺口结构216，参见图16。缺口结构216朝向流出道侧布设。
缺口结构216使得锚固框架不会跨越心室壁面，因此人工心脏瓣膜不会使心室壁过于抵靠在主动脉瓣的右侧或肺动脉瓣左侧，能够降低人工心脏瓣膜体对心脏功能的影响。
缺口结构216降低了流出段213的瓣下高度，从而降低了流出道阻塞的风险。缺口结构216的形状、面积应根据临床需要进行配置，并不用于限制本发明的保护范围。
以上公开的仅为本发明优选实施例。优选实施例并没有详尽叙述所有的细节，也不限制该发明仅为所述的具体实施方式。显然，根据本说明书的内容，可作很多的修改和变化。本说明书选取并具体描述这些实施例，是为了更好地解释本发明的原理和实际应用，从而使所属领域技术人员能很好地利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。

Claims (10)

  1. 一种人工心脏瓣膜，其特征在于，包括用于支撑人工瓣叶的支架主体，及用于将所述支架主体锚固至瓣环处的锚固框架；所述锚固框架配置在靠近流出道侧的预定位置处，所述支架主体配置在所述锚固框架外且远离所述流出道侧的预定位置处，所述锚固框架与所述支架主体相抵靠且连接。
  2. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述锚固框架的外周侧与所述支架主体外周侧相互抵靠，且在抵靠处连接。
  3. 根据权利要求1或2所述的人工心脏瓣膜，其特征在于，所述锚固框架与所述支架主体的抵靠处为单层结构。
  4. 根据权利要求3所述的人工心脏瓣膜，其特征在于，所述锚固框架或所述支架主体为非封闭结构。
  5. 根据权利要求4述的人工心脏瓣膜，其特征在于，所述锚固框架沿轴向为一开口结构，所述锚固框架的开口端与所述支架主体连接；或所述支架主体沿轴向为一开口结构，所述支架主体的开口端与所述锚固框架连接。
  6. 根据权利要求3所述的人工心脏瓣膜，其特征在于，在抵靠处，所述锚固框架的一部分为开口结构，所述支架主体与之抵靠的部分为非开口结构，同时所述锚固框架的其它部分为非开口结构，而所述支架主体与之抵靠的部分为开口结构。
  7. 根据权利要求1、2、4、5或6所述的人工心脏瓣膜，其特征在于，所述锚固框架具有一缺口结构，所述缺口结构位于所述锚固框架的流出段，且所述缺口结构配置为朝向流出道的方向。
  8. 根据权利要求1所述的人工心脏瓣膜，其特征在于，还包括至少一连接耳，所述心脏瓣膜通过所述连接耳与输送系统相连；所述连接耳设于所述支架主体或设于所述锚固框架。
  9. 根据权利要求1所述的心脏瓣膜假体，其特征在于，所述瓣膜包括人工瓣叶，瓣叶布设在主体部。
  10. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述锚固框架或所述 支架主体还布设有用于密封的裙边。
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