WO2023246120A1 - 人工心脏瓣膜 - Google Patents

人工心脏瓣膜 Download PDF

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Publication number
WO2023246120A1
WO2023246120A1 PCT/CN2023/075388 CN2023075388W WO2023246120A1 WO 2023246120 A1 WO2023246120 A1 WO 2023246120A1 CN 2023075388 W CN2023075388 W CN 2023075388W WO 2023246120 A1 WO2023246120 A1 WO 2023246120A1
Authority
WO
WIPO (PCT)
Prior art keywords
groove
artificial
stent
artificial valve
valve leaflet
Prior art date
Application number
PCT/CN2023/075388
Other languages
English (en)
French (fr)
Inventor
杨威
魏勇强
Original Assignee
江苏臻亿医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 江苏臻亿医疗科技有限公司 filed Critical 江苏臻亿医疗科技有限公司
Publication of WO2023246120A1 publication Critical patent/WO2023246120A1/zh

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Classifications

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

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to an artificial heart valve.
  • the human heart is divided into four chambers: left atrium, left ventricle, right atrium and right ventricle.
  • the membrane that separates the atrium from the ventricle is called the atrioventricular valve.
  • the atrioventricular valve is composed of leaflets, annulus, chordae tendineae and papillary muscles. The leaflets can open or close and function as a one-way valve so that blood can only flow from the atrium to the corresponding ventricle.
  • the atrioventricular valve that separates the left atrium from the left ventricle is the mitral valve
  • the atrioventricular valve that separates the right atrium from the right ventricle is the tricuspid valve.
  • transcatheter valve replacement Compared with traditional surgery, transcatheter valve replacement has the advantages of no need for thoracotomy, less trauma, and faster patient recovery, and has attracted widespread attention from experts and researchers.
  • the artificial heart valve leaflets of the replaced artificial heart valve are prone to stress concentration at the folds, which may lead to tearing or damage of the artificial heart valve leaflets, which can reduce the durability of the artificial heart valve.
  • Pleated prosthetic valve leaflets will also increase the risk of calcification of the prosthetic valve leaflets.
  • the object of the present invention is to provide an artificial heart valve in which the artificial valve leaflets can be evenly fixed on the stent, which can reduce the wrinkles of the artificial valve leaflets after being fixed and improve the uniformity of the force of the artificial valve leaflets, thereby improving the artificial heart valve leaflets. Durability and anti-calcification properties of heart valves after implantation.
  • the present invention provides an artificial heart valve, including a stent and an artificial valve leaflet.
  • the stent includes an interconnected grid and a first groove wall, and the first groove wall is formed to accommodate a portion of the heart valve.
  • the first groove of the artificial valve leaflet, the artificial valve leaflet can pass through the first groove and be connected with the first groove wall to achieve the fixation of the artificial valve leaflet on the stent.
  • the artificial valve leaflet can be bent after passing through the first groove, and can be sutured with the first groove wall through a suture line.
  • the stent has an inflow end and an outflow end opposite to each other along its axial direction, and the artificial valve leaflet can be bent toward the inflow end or toward the outflow end after passing through the first groove. fold.
  • the first groove is arranged along the circumference of the stent, and the shape of the first groove matches the shape of the artificial valve leaflet.
  • the first groove is an arc-shaped groove
  • the first groove is arranged symmetrically with respect to the axis of the bracket, and the width of the first groove in a direction perpendicular to its own extension is 0.1 mm ⁇ 1mm.
  • the stent further includes a second groove wall connected to the grid, the second groove wall enclosing a second groove for accommodating part of the artificial valve leaflets, part of the artificial valve leaflets The leaf can pass through the second groove and sew with the second groove wall.
  • the artificial valve leaflet includes a protruding part, a recessed part, an arc part and a smooth part, and the number of the protruding parts and the recessed parts is two; the two protruding parts are respectively connected with the smooth part.
  • the two opposite ends of the arc part are connected; the two recessed parts are respectively connected with the opposite ends of the arc part; each recessed part is connected with the corresponding one of the protruding parts;
  • the arc portion is used to pass through the first groove and is used to sew with the first groove wall; the protruding portion is used to pass through the second groove and is used to sew with the second groove wall. Wall suturing.
  • the second groove extends along the axial direction of the bracket, the length of the second groove in the direction of its own extension is 1 mm to 10 mm, and the length of the second groove in the direction perpendicular to its own extension is Width is 0.1mm ⁇ 2mm.
  • the artificial valve leaflet and the stent are sutured on the outer peripheral surface of the stent.
  • the suture line includes a line body and two knots respectively provided at opposite ends of the line body; after the artificial valve leaflet and the stent are sutured, the line body and the knots are are located on the outer peripheral surface of the stent.
  • the artificial valve leaflet is provided with multiple suture holes along its circumference;
  • the suture thread is used to pass through each of the suture holes in sequence, and after passing through each of the suture holes, it is connected to the first groove wall. wall connection.
  • the number of the suture lines is at least two, and each suture line is used to pass through a predetermined number of suture holes.
  • all the suture holes on the artificial valve leaflet are evenly distributed, and all the suture holes are symmetrically arranged on the artificial valve leaflet.
  • the artificial valve leaflet includes an arc portion, which is used to pass through the first groove and be sutured with the first groove wall; the distance between adjacent suture holes is 0.1mm ⁇ 3mm; the distance between the suture hole and the edge of the arc portion is 0.1mm ⁇ 5mm; the diameter of the suture hole is 0.1mm ⁇ 2mm.
  • the artificial heart valve includes: a stent and an artificial valve leaflet.
  • the stent includes an interconnected grid and a first groove wall.
  • the first groove wall is enclosed and formed to accommodate part of the artificial valve.
  • the first groove of the leaflet, the artificial valve leaflet can pass through the first groove and be connected with the first groove wall to achieve the fixation of the artificial valve leaflet on the stent.
  • the artificial valve leaflets can be fixedly connected to the first groove wall of the stent, so that the artificial valve leaflets can be evenly fixed on the stent, which can reduce the wrinkles of the artificial valve leaflets after being fixed and improve the blood flow of the artificial valve leaflets. It can improve the uniformity of force under impact and reduce the risk of stress concentration of artificial valve leaflets, thereby improving the durability and anti-calcification performance of artificial heart valves after implantation.
  • the artificial valve leaflets can pass through the first groove, and the part where the artificial valve leaflets penetrate and the first groove wall can be sutured on the outer peripheral surface of the stent, which can effectively avoid
  • the stress concentration of the artificial valve leaflets at the pins further improves the uniformity of force on the artificial valve leaflets and the durability and anti-calcification performance of the artificial heart valve after implantation.
  • Figure 1 is a simplified structural schematic diagram of an artificial heart valve in a preferred embodiment of the present invention, in which the dotted line is the axis of symmetry of the artificial valve leaflet;
  • Figure 2 is a partial structural schematic diagram of the bracket at a first observation angle in a preferred embodiment of the present invention
  • Figure 3 is a simplified top view of an artificial heart valve in a preferred embodiment of the present invention.
  • Figure 4 is a partial axial cross-sectional schematic diagram of an artificial heart valve in a preferred embodiment of the present invention.
  • Figure 5 is a partial structural diagram of the bracket at a second observation angle in a preferred embodiment of the present invention.
  • Figure 6 is a schematic structural diagram of an artificial valve leaflet in a preferred embodiment of the present invention.
  • Figure 7 is a partial structural schematic diagram of the artificial heart valve at a first observation angle in a preferred embodiment of the present invention.
  • Figure 8 is a partial structural schematic diagram of the artificial heart valve at a second viewing angle in a preferred embodiment of the present invention.
  • Figure 9 is a simplified top view of the artificial valve leaflets after suturing in a preferred embodiment of the present invention, in which there is only one suture line for sewing the artificial valve leaflets;
  • FIG 10 is a partially enlarged schematic diagram of the artificial valve leaflet after suturing in another preferred embodiment of the present invention.
  • Figure 11 is a partially enlarged schematic diagram of the artificial valve leaflet after suturing in another preferred embodiment of the present invention.
  • Bracket 1 Bracket 1; grid 11; first groove wall 12; first groove 13; inflow end 14; outflow end 15; second groove wall 16; second groove 17; artificial valve leaflet 2; suture hole 21; protruding portion 22; recessed portion 23; arc portion 24; smooth portion 25; suture 3; thread body 31; knot 32; Skirt 4.
  • orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation or be constructed in a specific orientation. and operation, and therefore cannot be construed as limitations of the present invention.
  • the terms “installation”, “connection”, “fixing” and other terms should be understood in a broad sense.
  • it can be a fixed connection, a detachable connection, or an integrated connection.
  • It can be a mechanical connection, a direct connection, or a connection through an intermediate medium, or an internal connection between two components or an interactive relationship between two components, unless otherwise clearly limited.
  • the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
  • “plurality” means at least two, such as two or three or more.
  • a preferred embodiment of the present invention provides an artificial heart valve for connecting with the native valve annulus and replacing the natural mitral valve or tricuspid valve.
  • the artificial heart valve includes a stent 1 and
  • the artificial valve leaflet 2 and the stent 1 include an interconnected grid 11 and a first groove wall 12.
  • the first groove wall 12 encloses a first groove 13 for accommodating part of the artificial valve leaflet 2.
  • the artificial valve leaflet 2 can pass through Pass through the first groove 13 and connect with the first groove wall 12 to achieve fixation of the artificial valve leaflet 2 on the stent 1 .
  • the fixation method of the artificial valve leaflets 2 is usually to sew the artificial valve leaflets 2 to the grid 11 of the stent 1. Since the position to be fixed on the artificial valve leaflets 2 is inconsistent with the structure of the grid 11, This causes some wrinkles to occur on the surface of the artificial valve leaflet 2 after the artificial valve leaflet 2 is fixed on the stent 1 . After the artificial heart valve is implanted in the body, since the surface of the artificial valve leaflet 2 will be impacted by blood flow for a long time, the artificial valve leaflet 2 will be unevenly stressed and local stress concentration will occur, which may lead to damage and calcification of the artificial valve leaflet 2 .
  • the artificial valve leaflet 2 provided by the present invention can be fixedly connected to the first groove wall 12 of the stent 1, and the artificial valve leaflet 2 can be evenly fixed on the stent 1 through the connection between the artificial valve leaflet 2 and the adjacent first groove wall 12. , this can reduce the wrinkles of the artificial valve leaflets 2 after they are fixed, make the force of the artificial valve leaflets 2 more uniform, and reduce the risk of stress concentration of the artificial valve leaflets 2, thereby improving the durability of the artificial heart valve after implantation and the artificial heart valve anti-calcification properties.
  • the stent 1 can provide several functions for the artificial heart valve, including serving as the main structure of the artificial heart valve, carrying the internal artificial valve leaflets 2, and connecting with the delivery system.
  • This application does not limit the structure of the stent 1.
  • the stent 1 can be prepared by braiding or laser cutting.
  • This application does not limit the material of the stent 1.
  • the stent 1 can be made of elastic materials such as nickel-titanium alloy or other materials with shape memory properties.
  • the stent 1 can also be made of titanium alloy, cobalt-chromium alloy, MP35N, 316 stainless steel and other materials. The preparation is of course not limited to this.
  • the stent 1 can also be made of a biocompatible metal frame or a laser-cut fixed metal tube, or a material that can be elastically or plastically deformed, such as a balloon-expandable material.
  • the artificial valve leaflet 2 can dynamically switch between open and closed states. In the closed state, the artificial valve leaflets 2 can be tightened or converged in a sealing and abutting manner.
  • the artificial valve leaflet 2 may be composed of two or three leaflets (the artificial valve leaflet 2 includes three leaflets in Figure 3).
  • the present invention does not limit the material of the artificial valve leaflet 2.
  • the artificial valve leaflet 2 can be formed of any suitable material or combination of materials.
  • the artificial valve leaflet 2 can be made of biological tissue material, such as chemically stable tissue from the heart valve of an animal, or pericardial tissue from an animal, such as bovine pericardium, sheep pericardium, pig pericardium or horse pericardium.
  • the tissue is preferably obtained from bovine pericardial tissue.
  • the artificial valve leaflet 2 can also be made of small intestinal submucosal tissue.
  • the artificial valve leaflet 2 may also be made of synthetic materials, which may include expanded polytetrafluoroethylene or polyester.
  • the synthetic material may also include one of thermoplastic polycarbonate urethane, polyether urethane, segmented polyether urethane, silicone polyether urethane, silicone-polycarbonate urethane, and ultra-high molecular weight polyethylene. one or more combinations.
  • the synthetic material may also include biocompatible polymers, such as polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, and other fluorine-containing polymers.
  • biocompatible polymers such as polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, and other fluorine-containing polymers.
  • This application also does not limit the shape of the grid 11 of the bracket 1.
  • the shape of the grid 11 can be set to a square, rectangle, or rhombus.
  • the artificial valve leaflet 2 can be bent after passing through the first groove 13, and can be sutured to the first groove wall 12 through the suture line 3, so that the artificial valve leaflet 2 can be connected to the first groove wall 12 of the stent 1
  • the suture has a large suture area, thereby achieving a firm connection between the artificial valve leaflet 2 and the stent 1 .
  • the portion of the artificial valve leaflet 2 that passes through the first groove 13 and is bent can be sutured to the first groove wall 12 .
  • the suture 3 can be made of PTFE, ePTFE or PE.
  • the artificial heart valve further includes a skirt 4 arranged along the outer peripheral surface of the stent 1 , and the skirt 4 is sewn to the stent 1 through a suture line 3 .
  • the skirt 4 can first be sutured to the outer peripheral surface of the stent 1 through the suture line 3, and then the artificial valve leaflet 2 and the stent 1 can be sutured.
  • the artificial valve leaflets 2 and the stent 1 may be sutured first, and then the skirt 4 may be sutured to the outer peripheral surface of the stent 1 .
  • the skirt 4 can be made of knitted, woven or woven polyester fabric, PTFE or ePTFE as needed.
  • the bracket 1 has an inflow end 14 and an outflow end 15 that are axially opposite.
  • the artificial valve leaflet 2 can be bent toward the inflow end 14 after passing through the first groove 13 (refer to FIG. 7 ).
  • the artificial valve leaflet 2 can also pass through the first groove 13 and then be bent toward the outflow end 15 (see FIG. 9 ). More specifically, as shown in Figure 4, after the artificial valve leaflet 2 passes through the first groove 13 of the stent 1, the artificial valve leaflet 2 can be bent toward the inflow end 14 with reference to the direction a in the figure, or can also be bent with reference to the direction a in the figure.
  • the b direction is bent toward the outflow end 15, and the specific bending direction of the artificial valve leaflet 2 can be set as needed.
  • the first groove 13 is arranged along the circumferential direction of the bracket 1 .
  • the first groove 13 has an annular structure.
  • the artificial valve leaflet 2 can pass through the first groove 13 to achieve the fixation of the entire outer peripheral surface of the artificial valve leaflet 2 to the first groove wall 12 .
  • the first groove 13 can also be a part of the annular structure. In this case, the artificial valve leaflet 2 can pass through the first groove 13 to realize the connection between part of the outer peripheral surface of the artificial valve leaflet 2 and the first groove wall 12 . fixed.
  • the shape of the first groove 13 matches the shape of the artificial valve leaflet 2, so that the distance between the artificial valve leaflet 2 and the first groove wall 12 after passing through the first groove 13 is basically the same, so as to realize the artificial valve leaflet. 2 evenly fixed on the bracket 1.
  • the first groove 13 is an arc-shaped groove, and the curvature of the first groove 13 is consistent with the curvature when the artificial valve leaflet 2 is connected to the stent 1, so that the artificial valve leaflet 2 can be sutured.
  • the suture lines 3 at different positions have the same shape, which can reduce the surface wrinkles of the artificial valve leaflet 2 after being sutured, so that the surface of the artificial valve leaflet 2 can receive even force after implantation.
  • the first groove 13 is arranged symmetrically with respect to the axis of the stent 1. At this time, the first groove 13 can match the shape of the artificial valve leaflet 2, and the wrinkles on the surface of the artificial valve leaflet 2 less. It should be understood that the axis of the stent 1 here refers to the straight line in the axial direction of the stent 1 .
  • the width of the first groove 13 in the direction perpendicular to its own extension is 0.1 mm to 1 mm to adapt to the thickness of different artificial valve leaflets 2 .
  • the width of the first groove 13 in the direction perpendicular to its own extension is 0.1 mm to 0.5 mm, so as to adapt to different specifications of commonly used artificial valve leaflets 2 .
  • the stent 1 further includes a second groove wall 16 connected to the grid 11 .
  • the second groove wall 16 encloses a second groove 17 for accommodating part of the artificial valve leaflets 2 . It can pass through the second groove 17 and be sutured with the second groove wall 16, so that the artificial valve leaflet 2 can be more firmly fixed on the stent 1 through suturing with the second groove wall 16.
  • the artificial valve leaflet 2 includes a protruding part 22 , a recessed part 23 , an arc part 24 and a smooth part 25 .
  • the number of the protruding parts 22 and the recessed parts 23 is two; the two protruding parts 22 are respectively connected to the opposite ends of the smooth part 25; the two recessed parts 23 are respectively connected to the opposite ends of the arc part 24, each Each recessed part 23 is connected to a corresponding protruding part 22 , that is, the artificial valve leaflet 2 includes a protruding part 22 , a smooth part 25 , a protruding part 22 , a recessed part 23 , an arc part 24 , and a recessed part 23 connected in sequence.
  • Both the protruding portion 22 and the arc portion 24 can protrude toward the outside of the artificial valve leaflet 2 relative to the recessed portion 23 , that is, the artificial valve leaflet 2 forms a recess at the recessed portion 23 .
  • the arc portion 24 is used to pass through the first groove 13 and is used to sew with the first groove wall 12
  • the protruding portion 22 is used to pass through the second groove 17 and is used to sew with the first groove wall 12.
  • the two groove walls 16 are sutured, so that the artificial valve leaflet 2 can be further firmly fixed on the stent 1 through the second groove 17, thereby preventing the artificial valve leaflet 2 from being displaced under long-term impact of blood flow.
  • the position of the second groove 17 corresponds to the position of the protruding portion 22 of the artificial valve leaflet 2
  • the shape of the second groove 17 corresponds to the shape of the protruding portion 22 of the artificial valve leaflet 2.
  • the recess 23 is used to abut the connection between the first groove wall 12 and the second groove wall 16 to define the fixed position of the artificial valve leaflet 2 on the stent 1 , that is to say, the artificial valve leaflet 2 and the stent 1
  • the recessed portion 23 can abut the connection between the first groove wall 12 and the second groove wall 16 so that the artificial valve leaflet 2 cannot continue to move outward in the radial direction of the stent 1 .
  • the “outward” direction in this application refers to the direction radially away from the axis of the stent 1
  • the “inward” direction refers to the direction radially toward the axis of the stent 1 .
  • the protruding portion 22 passes through the second groove 17 and is sewn to the second groove wall 16 through the suture line 3 .
  • the protruding length of the protruding portion 22 on the artificial valve leaflet 2 is greater than the protruding length of the arc portion 24 on the artificial valve leaflet 2 (that is, the arc portion 24 relative to the protruding length of the recessed portion 23), this allows the protruding portion 22 to have a larger suturing area during suturing to ensure that the artificial valve leaflet 2 is firmly fixed.
  • the number of artificial leaflets 2 of the artificial heart valve is multiple, and adjacent artificial valve leaflets 2 can be closed by the contact of adjacent smooth portions 25 .
  • the number of the artificial valve leaflets 2 is two; when the artificial heart valve replaces the tricuspid valve, the number of the artificial heart valve leaflets 2 is three ( See Figure 3).
  • the shape of the smooth portion 25 includes but is not limited to an upper arc (an arc protruding in a direction away from the arc portion 24), a lower arc ( An arc concave toward the arc portion 24) or a straight line.
  • the shape of the smooth portion 25 is preferably an upper arc, so that when multiple artificial valve leaflets 2 are closed, the smooth portions 25 of adjacent artificial valve leaflets 2 can contact and seal with each other to achieve complete closure of the multiple artificial valve leaflets 2 closure.
  • the dotted line in FIG. 6 is the axis of symmetry of the artificial valve leaflet 2 , that is, the line connecting the midpoint of the arc portion 24 and the midpoint of the smooth portion 25 .
  • the artificial valve leaflet 2 is arranged symmetrically with respect to the connecting line, and the two protruding parts 22 and the two recessed parts 23 are both arranged symmetrically with respect to the connecting line. This can further improve the efficiency of the artificial valve leaflet 2 after implantation. Uniformity of force.
  • the second groove 17 extends along the axial direction of the bracket 1 .
  • the protrusion 22 can penetrate into the second groove 17 in the vertical direction and be sewn with the second groove wall 16 .
  • the second groove 17 is rectangular, the length of the second groove 17 in its own extension direction is 1 mm to 10 mm, and the width of the second groove 17 in the direction perpendicular to its own extension is 0.1 mm to 2 mm.
  • the length of the second groove 17 in the direction of its own extension is 3 mm ⁇ 6 mm, and the width of the second groove 17 in the direction perpendicular to its own extension is 0.4 mm ⁇ 1 mm, so as to adapt to the different types of commonly used artificial valve leaflets 2 Specification.
  • the artificial valve leaflet 2 and the stent 1 are sutured on the outer peripheral surface of the stent 1.
  • the suture line 3 and the stitches on the artificial valve leaflet 2 that is, the artificial valve leaflet 2 passes through
  • the holes formed by the sutures 3) are evenly distributed on the outside of the stent 1.
  • the outside of the stent 1 refers to the side of the stent 1 away from its own axis
  • the inside of the stent 1 refers to the side of the stent 1 close to its own axis.
  • the pins on the artificial valve leaflet 2 are on the inside of the stent 1, the pins are exposed to the stress-bearing area of the artificial valve leaflet 2.
  • the artificial valve leaflet 2 is easily prone to stress concentration at the pins under the long-term impact of blood flow, and the artificial valve leaflets 2 are torn or calcified near the pins.
  • the pins on the artificial valve leaflet 2 are all arranged on the outside of the stent 1.
  • the force-bearing area) is complete and continuous, which can reduce or even avoid the stress concentration on the surface of the artificial valve leaflet 2, so it can improve the uniformity of the force on the artificial valve leaflet 2 and reduce the risk of calcification of the artificial valve leaflet 2.
  • the artificial valve leaflet 2 and the stent 1 can also be sutured on the inner peripheral surface of the stent 1.
  • the sutures 3 and the stitches on the artificial valve leaflet 2 are distributed inside the stent 1.
  • the artificial valve leaflet 2 is provided with a plurality of suture holes 21 along its circumferential direction.
  • the suture thread 3 is used to pass through each suture hole 21 in sequence, and is connected to the first groove wall 12 after passing through each suture hole 21 .
  • the suture 3 can bypass the first groove wall 12 after passing through each suture hole 21 and continue to penetrate the adjacent suture hole 21. In this way, the artificial valve leaflet 2 and the stent 1 are sutured.
  • the suture hole 21 on the artificial valve leaflet 2 can be processed by laser cutting, stamping or other mechanical processing.
  • the suture hole 21 can be prepared by laser cutting.
  • the suture 3 includes a thread body 31 and two knots 32 respectively provided at opposite ends of the thread body 31 . After the artificial valve leaflet 2 and the stent 1 are sutured, the thread body 31 and the knot 32 are located on the outer peripheral surface of the stent 1 .
  • the artificial valve leaflet 2 is sutured as follows: the suture 3 is knotted to form a first knot 32 and penetrated into the suture hole 21 from the outside of the stent 1, and then the suture 3 passes through the adjacent suture holes 21 in turn and The artificial valve leaflet 2 is sutured to the first groove wall 12, and finally the suture line 3 passes from the inside of the stent 1 to the outside of the stent 1 and is knotted to form another knot 32.
  • the suture 3 (including the thread body 31 and the knot 32) and the pins on the artificial valve leaflet 2 are always located outside the stent 1, so as to reduce the risk of stress concentration when the artificial valve leaflet 2 is impacted by blood flow and avoid artificial Damage and calcification of leaflet 2.
  • the suturing method of the artificial valve leaflets 2 can be selected as continuous suturing or interrupted suturing.
  • the continuous suturing method is to use only one suture thread 3 to pass through adjacent suture holes 21 in sequence to sew the artificial valve leaflet 2 and the first groove wall 12 .
  • the interrupted suturing method is to use two or more suture threads to sew the artificial valve leaflet 2 and the first groove wall 12 , wherein each suture thread 3 is only used to sew a part of the artificial valve leaflet 2 .
  • the interrupted suturing method can sew two regions of the artificial valve leaflet to the stent 1, and the suturing of each region and the stent 1 is independent of each other.
  • the suture 3 between the artificial valve leaflet 2 and the stent 1 breaks in a certain area, causing the artificial valve leaflet 2 and the stent 1 to separate in this area, the separation of the stent 1 and the artificial valve leaflet 2 in this area will not affect the stents in other areas. 1 and the artificial valve leaflet 2.
  • the artificial valve leaflet 2 can continue to be fixed on the stent 1 and work. This can greatly improve the anti-calcification performance of the artificial valve leaflet 2 and the overall durability of the artificial valve leaflet 2.
  • the number of sutures 3 is at least two, and each suture 3 is used to pass through a predetermined number of suture holes 21 , that is, the suturing method of the artificial valve leaflet 2 is interrupted suture.
  • each suture 3 The thread 3 is only used to sew a predetermined number of sewing holes 21 with the first groove wall 12 .
  • the predetermined number of suture holes 21 means that one suture 3 can pass through at least two suture holes 21 , and the actual number of suture holes 21 through which the suture 3 passes can be set according to actual needs.
  • the number of suture holes 21 through which one suture 3 passes can be appropriately reduced, so that the artificial valve leaflet can 2.
  • the number of mutually independent regions increases and the area of independent regions decreases.
  • each suture 3 can pass through three suture holes 21 , and one suture hole 21 is spaced between the suture holes 21 where the two knots 32 of the suture 3 are located.
  • each suture 3 can pass through 4 suture holes 21, and the suture holes 21 where the two knots 32 of the suture 3 are located are spaced by 2 suture holes. twenty one.
  • all the suture holes 21 on the artificial valve leaflet 2 are evenly distributed. At this time, the distance between all the suture holes 21 on the artificial valve leaflet 2 is equal. This can make the distribution of the suture lines 3 more even after the artificial valve leaflet 2 is sutured. , so that the suture position of the artificial valve leaflet 2 on the stent 1 is accurate, it can also reduce the wrinkles of the artificial valve leaflet 2 after suturing, and ensure that the artificial valve leaflet 2 is evenly stressed after implantation, so it can further reduce the stress of the artificial valve leaflet 2 Risk of tearing.
  • all suture holes 21 are symmetrically distributed on the artificial valve leaflet 2 .
  • the two separated parts of the artificial valve leaflet 2 can receive the same force, thereby ensuring the uniformity of the force on the artificial valve leaflet 2 .
  • adjacent suture holes The spacing of 21 can be set from 0.1mm to 3mm.
  • the distance between the suture hole 21 and the edge of the arc portion 24 can be set to 0.1 mm ⁇ 5 mm, and the diameter of the suture hole 21 can be set to 0.1 mm ⁇ 2 mm.
  • the distance between adjacent suture holes 21 is 0.5 mm ⁇ 1.5 mm
  • the distance between the suture holes 21 and the edge of the arc part 24 is 1 mm ⁇ 3 mm
  • the diameter of the suture holes 21 is 0.2 mm ⁇ 1 mm.
  • the artificial leaflets 2 of the artificial heart valve can be fixedly connected to the first groove wall 12 of the stent 1, so that the artificial valve leaflets 2 can be evenly fixed on the stent 1.
  • This can Reduce the wrinkles of the artificial valve leaflet 2 after being fixed, improve the uniformity of the force of the artificial valve leaflet 2 under the impact of blood flow, and reduce the risk of stress concentration of the artificial valve leaflet 2, thereby improving the durability of the artificial heart valve after implantation and anti-calcification properties.
  • the artificial valve leaflet 2 can pass through the first groove 13, and the part where the artificial valve leaflet 2 penetrates can be sutured with the first groove wall 12 on the outer peripheral surface of the stent 1, so that It can effectively avoid the stress concentration of the artificial valve leaflet 2 at the pins, further improve the uniformity of the force of the artificial valve leaflet 2 and the durability of the artificial heart valve after implantation.

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Abstract

本发明提供一种人工心脏瓣膜，包括支架和人工瓣叶，所述支架包括相互连接的网格和第一槽壁，所述第一槽壁围合形成用于容纳部分所述人工瓣叶的第一凹槽，所述人工瓣叶能够穿过所述第一凹槽并与所述第一槽壁连接，以实现所述人工瓣叶在所述支架上的固定。该人工心脏瓣膜的人工瓣叶能够在支架上均匀的固定，如此可减少瓣叶固定后的褶皱，并提升瓣叶受力的均匀性，进而可提高人工心脏瓣膜植入后的耐久性和抗钙化性能。

Description

人工心脏瓣膜 技术领域
本发明涉及医疗器械技术领域，特别涉及一种人工心脏瓣膜。
背景技术
随着社会经济的发展和人口老龄化的加重，老年性瓣膜病以及冠心病、心机梗死后引起的瓣膜病变也越来越常见。研究表明，超过13.3％的75岁以上的老年人患有不同程度的瓣膜性心脏病。心脏瓣膜疾病已逐渐成为威胁人类健康的重要原因之一。
人体的心脏分为左心房、左心室、右心房和右心室共四个腔室，将心房与心室分开的薄膜被称为房室瓣。房室瓣由瓣叶、瓣环、腱索和***肌组成，所述瓣叶能够打开或关闭并起到单向阀的作用，以使血液仅能由心房流向相应的心室。其中，将左心房与左心室分开的房室瓣为二尖瓣，将右心房与右心室分开的房室瓣为三尖瓣。
与传统外科手术相比，经导管瓣膜的置换术具有无需开胸、创伤小、患者恢复快等优点、已受到专家学者的广泛关注。然而，置换后的人工心脏瓣膜在血流的长期冲击下，其人工瓣叶在褶皱处较易产生应力集中而导致人工瓣叶的撕裂或破损，如此可降低人工心脏瓣膜的耐久性，具有褶皱的人工瓣叶还将提高人工瓣叶的钙化风险。
发明内容
本发明的目的在于提供一种人工心脏瓣膜，其中人工瓣叶能够在支架上均匀地固定，如此可减少人工瓣叶固定后的褶皱，并提升人工瓣叶受力的均匀性，进而可提高人工心脏瓣膜植入后的耐久性和抗钙化性能。
为实现上述目的，本发明提供一种人工心脏瓣膜，包括支架和人工瓣叶，所述支架包括相互连接的网格和第一槽壁，所述第一槽壁围合形成用于容纳部分所述人工瓣叶的第一凹槽，所述人工瓣叶能够穿过所述第一凹槽并与所述第一槽壁连接，以实现所述人工瓣叶在所述支架上的固定。
可选的，所述人工瓣叶能够在穿过所述第一凹槽后弯折，并能够通过缝合线与所述第一槽壁缝合。
可选的，所述支架具有沿其轴向相对的流入端和流出端，所述人工瓣叶在穿过所述第一凹槽后能够朝向所述流入端弯折或朝向所述流出端弯折。
可选的，所述第一凹槽沿所述支架的周向布置，所述第一凹槽的形状与所述人工瓣叶的形状相匹配。
可选的，所述第一凹槽为弧形凹槽，所述第一凹槽关于所述支架的轴线对称设置，且所述第一凹槽在垂直自身延伸方向上的宽度为0.1mm～1mm。
可选的，所述支架还包括与所述网格连接的第二槽壁，所述第二槽壁围合形成用于容纳部分所述人工瓣叶的第二凹槽，部分所述人工瓣叶能够穿过所述第二凹槽并与所述第二槽壁缝合。
可选的，所述人工瓣叶包括突出部、凹陷部、圆弧部和平滑部，所述突出部和所述凹陷部的数量均为两个；两个所述突出部分别与所述平滑部的相对两端连接；两个所述凹陷部分别与所述圆弧部的相对两端连接；每个所述凹陷部与对应的一个所述突出部连接；
所述圆弧部用于穿过所述第一凹槽，并用于与所述第一槽壁缝合；所述突出部用于穿过所述第二凹槽，并用于与所述第二槽壁缝合。
可选的，所述第二凹槽沿所述支架的轴向延伸，所述第二凹槽在自身延伸方向上的长度为1mm～10mm，所述第二凹槽在垂直自身延伸方向上的宽度为0.1mm～2mm。
可选的，所述人工瓣叶和所述支架在所述支架的外周面上进行缝合。
可选的，所述缝合线包括线体和分别设置在所述线体的相对两端的两个结头；在所述人工瓣叶和所述支架缝合后，所述线体和所述结头均位于所述支架的外周面上。
可选的，所述人工瓣叶沿自身周向设置有多个缝合孔；
当所述人工瓣叶与所述第一槽壁缝合时，所述缝合线用于依次穿过每个所述缝合孔，且在穿过每个所述缝合孔后均与所述第一槽壁连接。
可选的，所述缝合线的数量为至少两根，每根所述缝合线用于穿过预定数量的缝合孔。
可选的，所述人工瓣叶上的所有所述缝合孔均匀分布，所有所述缝合孔在所述人工瓣叶上对称设置。
可选的，所述人工瓣叶包括圆弧部，所述圆弧部用于穿过所述第一凹槽，并用于与所述第一槽壁缝合；相邻所述缝合孔的间距为0.1mm～3mm；所述缝合孔与所述圆弧部的边缘的距离为0.1mm～5mm；所述缝合孔的直径为0.1mm～2mm。
在本发明提供的人工心脏瓣膜中，包括：支架和人工瓣叶，所述支架包括相互连接的网格和第一槽壁，所述第一槽壁围合形成用于容纳部分所述人工瓣叶的第一凹槽，所述人工瓣叶能够穿过所述第一凹槽并与所述第一槽壁连接，以实现所述人工瓣叶在所述支架上的固定。如此配置后，使得人工瓣叶能够与支架的第一槽壁固定连接，从而可实现人工瓣叶在支架上的均匀固定，如此可减少人工瓣叶固定后的褶皱，提升人工瓣叶在血流的冲击下受力的均匀性，并降低人工瓣叶的应力集中风险，继而可提升人工心脏瓣膜植入后的耐久性和抗钙化性能。
本发明提供的人工心脏瓣膜中，所述人工瓣叶能够穿过第一凹槽，并能够将人工瓣叶穿入的部分与第一槽壁在支架的外周面上进行缝合，如此可有效避免人工瓣叶在针脚处的应力集中，进一步提升人工瓣叶受力的均匀性和人工心脏瓣膜植入后的耐久性和抗钙化性能。
附图说明
图1为本发明一优选实施例中人工心脏瓣膜的简化结构示意图，其中，虚线为人工瓣叶的对称轴线；
图2为本发明一优选实施例中支架在第一观察角度下的部分结构示意图；
图3为本发明一优选实施例中人工心脏瓣膜的简化俯视示意图；
图4为本发明一优选实施例中人工心脏瓣膜的部分轴向截面示意图；
图5为本发明一优选实施例中支架在第二观察角度下的部分结构示意图；
图6为本发明一优选实施例中人工瓣叶的结构示意图；
图7为本发明一优选实施例中人工心脏瓣膜在第一观察角度下的部分结构示意图；
图8为本发明一优选实施例中人工心脏瓣膜在第二观察角度下的部分结构示意图；
图9为本发明一优选实施例中的人工瓣叶缝合后的简化俯视示意图，其中，缝合人工瓣叶的缝合线为一根；
图10为本发明另一优选实施例中的人工瓣叶缝合后的局部放大示意图，其中，缝合人工瓣叶的缝合线为多根，且每根缝合线的两个结头中间间隔一个缝合孔；
图11为本发明另一优选实施例中的人工瓣叶缝合后的局部放大示意图，其中，缝合人工瓣叶的缝合线为多根，且每根缝合线的两个结头中间间隔两个缝合孔。
[附图标记说明如下]：
支架1；网格11；第一槽壁12；第一凹槽13；流入端14；流出端15；
第二槽壁16；第二凹槽17；人工瓣叶2；缝合孔21；突出部22；凹陷部23；圆弧部24；平滑部25；缝合线3；线体31；结头32；裙边4。
具体实施方式
以下结合附图和具体实施例对本发明作进一步详细说明。根据下面说明，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”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。
在本发明中，除非另有明确的规定和限定，术语“安装”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，可以是直接相连，也可以通过中间媒介相连，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限 定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。本发明的描述中，“多个”的含义是至少两个，例如两个或三个或更多个等。
以下结合附图和优选实施例对本发明作详细的说明。在不冲突的情况下，下述的实施方式及实施方式中的特征可以相互补充或相互组合。
如图1和图2所示，本发明一优选实施例提供一种人工心脏瓣膜，用于与原生瓣环连接并替代天然的二尖瓣或三尖瓣，所述人工心脏瓣膜包括支架1和人工瓣叶2，支架1包括相互连接的网格11和第一槽壁12，第一槽壁12围合形成用于容纳部分人工瓣叶2的第一凹槽13，人工瓣叶2能够穿过第一凹槽13并与第一槽壁12连接，以实现人工瓣叶2在支架1上的固定。
在传统的人工心脏瓣膜中，人工瓣叶2的固定方法通常是将人工瓣叶2缝合在支架1的网格11上，由于人工瓣叶2上需要固定的位置与网格11的结构不一致，这就使得人工瓣叶2在支架1上固定后，人工瓣叶2的表面产生一些褶皱。在人工心脏瓣膜植入体内后，由于人工瓣叶2的表面会长期受到血流的冲击，使得人工瓣叶2受力不均，局部产生应力集中，进而可导致人工瓣叶2的损坏和钙化。
本发明提供的人工瓣叶2能够与支架1的第一槽壁12固定连接，并可通过人工瓣叶2与相邻第一槽壁12的连接实现人工瓣叶2在支架1上的均匀固定，如此可减少人工瓣叶2固定后的褶皱，使得人工瓣叶2受力更加均匀，并降低人工瓣叶2的应力集中风险，从而可提升人工心脏瓣膜植入后的耐久性和人工心脏瓣膜的抗钙化性能。
本申请实施例中，支架1能够为人工心脏瓣膜提供若干功能，包括用作人工心脏瓣膜的主体结构、承载内部人工瓣叶2、与输送***连接等。本申请对支架1的结构不作限定，例如支架1可采用编织的方式制备或由激光切割制备而成。本申请对支架1的材料亦不作限定，例如支架1可采用镍钛合金等弹性材料或其他具有形状记忆特性的材料制备，支架1还可采用钛合金、钴铬合金、MP35N、316不锈钢等材料进行制备，当然不限于此，支架1也可以选择生物相容性金属框架或激光切割的固定金属管制备，或选择可弹性或可塑性变形的材料制备，例如采用球囊可扩张的材料制备。
进一步地，人工瓣叶2可在打开和闭合两种状态间动态切换。在所述闭合状态中，人工瓣叶2可以以密封和抵接的方式合紧或会合。可选地，人工瓣叶2可由两片或三片小叶组成(图3中人工瓣叶2包括三片小叶)。
本发明对人工瓣叶2的材料不作限定，人工瓣叶2可由任意合适的材料或材料的组合形成。在一些实施例中，人工瓣叶2可选择生物组织材料，例如取自动物的心脏瓣膜中化学性能稳定的组织，或者取自动物的心包组织，例如牛心包、羊心包、猪心包或马心包组织，优选取自牛心包组织。在另一些实施例中，人工瓣叶2也可以由小肠粘膜下组织制成。在其他实施例中，人工瓣叶2还可由合成材料制备，所述合成材料可包括膨体聚四氟乙烯或聚酯。可选地，所述合成材料还可包括热塑性聚碳酸酯聚氨酯、聚醚聚氨酯、分段聚醚聚氨酯、有机硅聚醚聚氨酯、有机硅-聚碳酸酯聚氨酯、以及超高分子量聚乙烯中的一种或多种组合。较佳的，所述合成材料还可包括生物相容的聚合物，例如聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯基吡咯烷酮、聚氯乙烯、其它的含氟聚合物、有机硅聚酯、硅氧烷聚合物、硅氧烷低聚物以及硅氧烷内酯中的一种或多种组合，以及使用它们的嵌段共聚物。
本申请对支架1的网格11的形状亦不作限定，例如可将网格11的形状设置为正方形、长方形或菱形等。
进一步地，人工瓣叶2能够在穿过第一凹槽13后弯折，并能够通过缝合线3与第一槽壁12缝合，如此可使人工瓣叶2与支架1的第一槽壁12缝合时具有较大的缝合面积，从而实现人工瓣叶2和支架1的牢固连接。在本实施例中，可将人工瓣叶2中穿过第一凹槽13并弯折的部分与第一槽壁12进行缝合。本申请对缝合线3的材料不作限定，例如可采用PTFE、ePTFE或PE等材料制作缝合线3。
继续参照图1，所述人工心脏瓣膜还包括沿支架1的外周面设置的裙边4，裙边4通过缝合线3与支架1缝合。在一实施例中，可先将裙边4通过缝合线3缝合在支架1的外周面上，再将人工瓣叶2与支架1进行缝合。在另一实施例中，也可先将人工瓣叶2与支架1进行缝合，再将裙边4缝合在支架1的外周面上。本申请对裙边4的材料不作限定，裙边4可根据需要选用针织、梭织或编织的聚酯织物、PTFE或ePTFE等材料制备。
参照图2所示，所述支架1具有沿轴向相对的流入端14和流出端15。在一实施例中，人工瓣叶2能够在穿过第一凹槽13后朝向流入端14弯折(参照图7)。在另一实施例中，人工瓣叶2还能够穿过第一凹槽13后朝向流出端15弯折(参照图9)。更详细的，如图4所示，在人工瓣叶2穿过支架1的第一凹槽13后，人工瓣叶2可参照图中的a方向朝向流入端14弯折，也可参照图中的b方向朝向流出端15弯折，人工瓣叶2具体的弯折方向可根据需要进行设置。
优选的，第一凹槽13沿支架1的周向布置。在一优选实施例中，第一凹槽13为环形结构，此时人工瓣叶2可穿过第一凹槽13而实现人工瓣叶2的整个外周面与第一槽壁12的固定。在其他实施例中，第一凹槽13也可为环形结构的一部分，此时人工瓣叶2可穿过第一凹槽13而实现人工瓣叶2的部分外周面与第一槽壁12的固定。
进一步地，第一凹槽13的形状与人工瓣叶2的形状相匹配，从而使人工瓣叶2穿过第一凹槽13后与第一槽壁12的距离基本相同，以实现人工瓣叶2在支架1上的均匀固定。
在本实施例中，第一凹槽13为弧形凹槽，且第一凹槽13的弧度与人工瓣叶2与支架1连接时的弧度相一致，如此在人工瓣叶2缝合时可使不同位置缝合线3的形态一致，从而能够减少人工瓣叶2缝合后的表面褶皱，使得人工瓣叶2的表面植入后能够受力均匀。
参照图2所示，在本实施例中，第一凹槽13关于支架1的轴线对称设置，此时第一凹槽13能够匹配人工瓣叶2的形状，且人工瓣叶2的表面的褶皱较少。应理解，此处支架1的轴线是指支架1的轴向上的直线。
进一步地，第一凹槽13在垂直自身延伸方向上的宽度为0.1mm～1mm，以适配不同人工瓣叶2的厚度。优选的，第一凹槽13在垂直自身延伸方向上的宽度为0.1mm～0.5mm，以适配常用的人工瓣叶2的不同规格。
参照图5所示，支架1还包括与网格11连接的第二槽壁16，第二槽壁16围合形成用于容纳部分人工瓣叶2的第二凹槽17，部分人工瓣叶2能够穿过第二凹槽17并与第二槽壁16缝合，如此可使人工瓣叶2通过与第二槽壁16的缝合更加牢靠的固定在支架1上。
参照图6所示，在一实施例中，所述人工瓣叶2包括突出部22、凹陷部23、圆弧部24和平滑部25。所述突出部22和凹陷部23的数量均为两个；两个突出部22分别与平滑部25的相对两端连接；两个凹陷部23分别与圆弧部24的相对两端连接，每个凹陷部23与对应的一个突出部22连接，也即人工瓣叶2包括首尾依次连接的突出部22、平滑部25、突出部22、凹陷部23、圆弧部24、凹陷部23。其中，突出部22和圆弧部24均能够相对于凹陷部23朝向人工瓣叶2的外侧突伸，也即人工瓣叶2在凹陷部23处形成凹缺。参照图7和图8所示，圆弧部24用于穿过第一凹槽13，并用于与第一槽壁12缝合，突出部22用于穿过第二凹槽17，并用于与第二槽壁16缝合，如此可通过第二凹槽17进一步使人工瓣叶2牢固的固定在支架1上，从而可避免人工瓣叶2在血流的长期冲击下发生移位。
在本实施例中，第二凹槽17的设置位置与人工瓣叶2中的突出部22的位置相对应，第二凹槽17的形状与人工瓣叶2的突出部22的形状相对应，以实现突出部22在第二槽壁16处的缝合。
进一步地，凹陷部23用于抵接第一槽壁12和第二槽壁16的连接处，以限定人工瓣叶2在支架1上的固定位置，也就是说，人工瓣叶2与支架1固定时，凹陷部23能够与第一槽壁12和第二槽壁16的连接处相抵接，以使人工瓣叶2不能继续沿支架1的径向向外移动。应知晓，本申请中的“向外”的方向是指径向远离支架1轴线的方向，而“向内”的方向则是指径向朝向支架1轴线的方向。
在本实施例中，突出部22穿过第二凹槽17后通过缝合线3与第二槽壁16缝合。优选的，突出部22在人工瓣叶2上的突伸长度(即突出部22相对于凹陷部23突出的长度)大于圆弧部24在人工瓣叶2上的突伸长度(即圆弧部24相对于凹陷部23突出的长度)，如此可使突出部22在缝合时能够具有更大的缝合面积，以确保人工瓣叶2固定牢固。
参照图3所示，人工心脏瓣膜的人工瓣叶2的数量为多个，且相邻的人工瓣叶2可通过相邻平滑部25的抵接而实现人工瓣叶2的闭合。其中，当人工心脏瓣膜置换二尖瓣时，所述人工瓣叶2的数量为两个；当人工心脏瓣膜置换三尖瓣时，所述人工心脏瓣膜的人工瓣叶2的数量为三个(参见图3)。
本申请对人工瓣叶2中平滑部25的形状不作限定，所述平滑部25的形状包括但不限于上弧线(朝远离圆弧部24的方向突伸的圆弧)、下弧线(朝靠近圆弧部24的方向凹陷的圆弧)、平直线。平滑部25的形状优选为上弧线，如此可在多个人工瓣叶2闭合时，相邻人工瓣叶2的平滑部25能够相互抵接且密封，以实现多个人工瓣叶2的完全闭合。
图6中的虚线为人工瓣叶2的对称轴线，也即圆弧部24的中点与平滑部25的中点的连线。在本实施例中，人工瓣叶2关于所述连线对称设置，同时两个突出部22和两个凹陷部23均关于所述连线对称设置，如此可进一步提高人工瓣叶2植入后受力的均匀性。
参照图5和图8所示，第二凹槽17沿支架1的轴向延伸，此时突出部22可沿竖直方向穿入第二凹槽17内，并与第二槽壁16缝合。在本实施例中，第二凹槽17为长方形，第二凹槽17在自身延伸方向上的长度为1mm～10mm，第二凹槽17在垂直自身延伸方向上的宽度为0.1mm～2mm，以适配不同人工瓣叶2的形状。优选的，第二凹槽17在自身延伸方向上的长度为3mm～6mm，第二凹槽17在垂直自身延伸方向上的宽度为0.4mm～1mm，以适配常用的人工瓣叶2的不同规格。
参照图3所示，在一优选实施例中，人工瓣叶2和支架1在支架1的外周面上进行缝合，此时缝合线3和人工瓣叶2上的针脚(即人工瓣叶2穿过缝合线3形成的孔洞)均分布在支架1的外侧。应理解，支架1的外侧是指支架1远离自身轴线的一侧，所述支架1的内侧是指支架1靠近自身轴线的一侧。
由于人工心脏瓣膜植入人体后，血流会长期冲击支架1的内侧，故当人工瓣叶2上的针脚在支架1的内侧时，所述针脚被暴露在人工瓣叶2的受力区域，使得人工瓣叶2在血流的长期冲击下极易在针脚处产生应力集中，进而使人工瓣叶2在针脚附近发生撕裂或钙化。
本发明中，在人工瓣叶2与支架1缝合时，将人工瓣叶2上的针脚均设置在支架1的外侧，此时设置在支架1内侧的人工瓣叶2(即人工瓣叶2的受力区域)完整且连续，如此可减少甚至避免人工瓣叶2表面的应力集中，故可提高人工瓣叶2受力的均匀性，并降低人工瓣叶2的钙化风险。
当然在其他实施例中，也可将人工瓣叶2和支架1在支架1的内周面上进行缝合，此时缝合线3和人工瓣叶2上的针脚均分布在支架1的内侧。
参照图6～图8所示，在一优选实施例中，所述人工瓣叶2上沿自身周向设置有多个缝合孔21。当人工瓣叶2与第一槽壁12缝合时，缝合线3用于依次穿过每个缝合孔21，且在穿过每个缝合孔21后均与第一槽壁12连接。更详细的，在人工瓣叶2与第一槽壁12缝合时，缝合线3能够在穿过每个缝合孔21后均绕过第一槽壁12并继续穿入相邻的缝合孔21，以此实现人工瓣叶2与支架1的缝合。如此构造，可使人工瓣叶2在支架1上缝合时，缝合线3穿过人工瓣叶2的各位置间的距离均相等，如此可进一步使人工瓣叶2均匀的缝合在支架1上，还可进一步减少人工瓣叶2缝合时在表面形成的褶皱。
本申请对缝合孔21的加工方法不作限定，人工瓣叶2上的缝合孔21可通过激光切割、冲压或其他机械形式加工制备，优选可采用激光切割制备缝合孔21。
参照图9～11所示，缝合线3包括线体31和分别设置在线体31的相对两端的两个结头32。在人工瓣叶2和支架1缝合后，线体31和结头32均位于支架1的外周面上。具体的，人工瓣叶2缝合的方式为：缝合线3打结形成第一个结头32并从支架1的外侧穿入缝合孔21，而后缝合线3依次穿过相邻缝合孔21并将人工瓣叶2与第一槽壁12缝合，最后缝合线3从支架1的内侧穿出至支架1的外侧后打结形成另一个结头32。如此可使缝合线3(包括线体31和结头32)以及人工瓣叶2上的针脚始终位于支架1的外侧，以便降低人工瓣叶2在受到血流冲击时的应力集中风险，避免人工瓣叶2的损坏和钙化。
进一步地，人工瓣叶2的缝合方式可选为连续缝合或间断缝合。所述连续缝合方式为仅使用一根缝合线3依次穿过相邻的缝合孔21，以将人工瓣叶2与第一槽壁12进行缝合。所述间断缝合方式为使用两根以上的缝合线将人工瓣叶2与第一槽壁12进行缝合，其中，每根缝合线3仅用于缝合人工瓣叶2的一部分区域。
当人工瓣叶2采用连续缝合的方式时，一旦人工瓣叶2和支架1之间的缝合线3断裂，人工瓣叶2的所有区域均将与支架1分离，从而导致人工瓣 叶2在支架1上的脱落。相比于连续缝合，采用间断缝合，一方面能够减少人工瓣叶2缝合时形成的材料堆积(即褶皱)，从而可减轻甚至避免人工瓣叶2因材料堆积导致的受力不均，还可提高人工瓣叶2的使用寿命，降低人工瓣叶2的钙化风险。另一方面，间断缝合的缝合方式能够将人工瓣叶2分区域缝合在支架1上，且各区域与支架1的缝合相互独立。当某一区域人工瓣叶2与支架1的缝合线3断裂而导致人工瓣叶2与支架1在该区域分离时，该区域中支架1和人工瓣叶2的分离不会影响其他区域中支架1和人工瓣叶2的连接，此时人工瓣叶2仍可继续被固定在支架1上而进行工作，如此可大大提高人工瓣叶2的抗钙化性能和人工瓣叶2整体的耐久性。
优选的，所述缝合线3的数量为至少两根，且每根缝合线3用于穿过预定数量的缝合孔21，也即人工瓣叶2的缝合方式为间断缝合，此时每根缝合线3仅用于将预定数量的缝合孔21与第一槽壁12进行缝合。应理解，所述预定数量的缝合孔21是指一根缝合线3能够穿过至少两个缝合孔21，缝合线3穿过的缝合孔21的实际数量可根据实际需要进行设置。
为使一根或少数几根缝合线3的断裂对支架1和人工瓣叶2固定连接的影响较小，可适当减少一根缝合线3穿过的缝合孔21的数量，而使人工瓣叶2缝合时相互独立的区域的数量增多而独立区域的面积减小。
参照图10所示，在一具体实施例中，每根缝合线3可穿过3个缝合孔21，且缝合线3的两个结头32所在的缝合孔21之间间隔一个缝合孔21。参照图11所示，在另一具体实施例中，每根缝合线3可穿过4个缝合孔21，且缝合线3的两个结头32所在的缝合孔21之间间隔2个缝合孔21。
更优选的，人工瓣叶2上的所有缝合孔21均匀分布，此时人工瓣叶2上的所有缝合孔21的间距均相等，如此可使人工瓣叶2缝合后缝合线3的分布较为均匀，以使人工瓣叶2在支架1上的缝合位置准确，还可减少人工瓣叶2缝合后的褶皱，并确保人工瓣叶2植入后受力均匀，故可进一步降低人工瓣叶2的撕裂风险。
参照图6所示，所有缝合孔21在人工瓣叶2上对称分布。以使人工瓣叶2被分隔而成的两部分能够受力一致，进而可确保人工瓣叶2受力的均匀性。
进一步地，为确保人工瓣叶2能够承受一定的血流冲击力，相邻缝合孔 21的间距可设置为0.1mm～3mm。此外，为便于人工瓣叶2与支架1的缝合，缝合孔21与圆弧部24的边缘的距离可设置为0.1mm～5mm，缝合孔21的直径可设置为0.1mm～2mm。在一优选实施例中，相邻缝合孔21的间距为0.5mm～1.5mm，缝合孔21与圆弧部24的边缘的距离为1mm～3mm，缝合孔21的直径为0.2mm～1mm，以适配常用的人工瓣叶2的不同规格。
综上，本发明提供的人工心脏瓣膜中，人工心脏瓣膜的人工瓣叶2能够与支架1的第一槽壁12固定连接，从而可实现人工瓣叶2在支架1上的均匀固定，如此可减少人工瓣叶2固定后的褶皱，并提升人工瓣叶2在血流的冲击下受力的均匀性、降低人工瓣叶2的应力集中风险，继而可提升人工心脏瓣膜植入后的耐久性和抗钙化性能。
本发明提供的人工心脏瓣膜中，人工瓣叶2能够穿过第一凹槽13，并能够将人工瓣叶2穿入的部分与第一槽壁12在支架1的外周面上进行缝合，如此可有效避免人工瓣叶2在针脚处的应力集中，进一步提升人工瓣叶2受力的均匀性和人工心脏瓣膜植入后的耐久性。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于本发明的保护范围。

Claims (14)

  1. 一种人工心脏瓣膜，包括支架和人工瓣叶，其特征在于，所述支架包括相互连接的网格和第一槽壁，所述第一槽壁围合形成用于容纳部分所述人工瓣叶的第一凹槽，所述人工瓣叶能够穿过所述第一凹槽并与所述第一槽壁连接，以实现所述人工瓣叶在所述支架上的固定。
  2. 如权利要求1所述的人工心脏瓣膜，其特征在于，所述人工瓣叶能够在穿过所述第一凹槽后弯折，并能够通过缝合线与所述第一槽壁缝合。
  3. 如权利要求2所述的人工心脏瓣膜，其特征在于，所述支架具有沿其轴向相对的流入端和流出端，所述人工瓣叶在穿过所述第一凹槽后能够朝向所述流入端弯折或朝向所述流出端弯折。
  4. 如权利要求1所述的人工心脏瓣膜，其特征在于，所述第一凹槽沿所述支架的周向布置，所述第一凹槽的形状与所述人工瓣叶的形状相匹配。
  5. 如权利要求1所述的人工心脏瓣膜，其特征在于，所述第一凹槽为弧形凹槽，所述第一凹槽关于所述支架的轴线对称设置，且所述第一凹槽在垂直自身延伸方向上的宽度为0.1mm～1mm。
  6. 如权利要求2所述的人工心脏瓣膜，其特征在于，所述支架还包括与所述网格连接的第二槽壁，所述第二槽壁围合形成用于容纳部分所述人工瓣叶的第二凹槽，部分所述人工瓣叶能够穿过所述第二凹槽并与所述第二槽壁缝合。
  7. 如权利要求6所述的人工心脏瓣膜，其特征在于，所述人工瓣叶包括突出部、凹陷部、圆弧部和平滑部，所述突出部和所述凹陷部的数量均为两个；两个所述突出部分别与所述平滑部的相对两端连接；两个所述凹陷部分别与所述圆弧部的相对两端连接；每个所述凹陷部与对应的一个所述突出部连接；
    所述圆弧部用于穿过所述第一凹槽，并用于与所述第一槽壁缝合；所述突出部用于穿过所述第二凹槽，并用于与所述第二槽壁缝合。
  8. 如权利要求6所述的人工心脏瓣膜，其特征在于，所述第二凹槽沿所述支架的轴向延伸，所述第二凹槽在自身延伸方向上的长度为1mm～10mm，所述第二凹槽在垂直自身延伸方向上的宽度为0.1mm～2mm。
  9. 如权利要求2-8中任一项所述的人工心脏瓣膜，其特征在于，所述人工瓣叶和所述支架在所述支架的外周面上进行缝合。
  10. 如权利要求9所述的人工心脏瓣膜，其特征在于，所述缝合线包括线体和分别设置在所述线体的相对两端的两个结头；在所述人工瓣叶和所述支架缝合后，所述线体和所述结头均位于所述支架的外周面上。
  11. 如权利要求2-8中任一项所述的人工心脏瓣膜，其特征在于，所述人工瓣叶沿自身周向设置有多个缝合孔；
    当所述人工瓣叶与所述第一槽壁缝合时，所述缝合线用于依次穿过每个所述缝合孔，且在穿过每个所述缝合孔后均与所述第一槽壁连接。
  12. 如权利要求11所述的人工心脏瓣膜，其特征在于，所述缝合线的数量为至少两根，每根所述缝合线用于穿过预定数量的缝合孔。
  13. 如权利要求11所述的人工心脏瓣膜，其特征在于，所述人工瓣叶上的所有所述缝合孔均匀分布，所有所述缝合孔在所述人工瓣叶上对称设置。
  14. 如权利要求11所述的人工心脏瓣膜，其特征在于，所述人工瓣叶包括圆弧部，所述圆弧部用于穿过所述第一凹槽，并用于与所述第一槽壁缝合；相邻所述缝合孔的间距为0.1mm～3mm；所述缝合孔与所述圆弧部的边缘的距离为0.1mm～5mm；所述缝合孔的直径为0.1mm～2mm。
PCT/CN2023/075388 2022-06-24 2023-02-10 人工心脏瓣膜 WO2023246120A1 (zh)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6461382B1 (en) * 2000-09-22 2002-10-08 Edwards Lifesciences Corporation Flexible heart valve having moveable commissures
CN106456322A (zh) * 2014-03-11 2017-02-22 爱普贡公司 人工单瓣叶瓣膜及输送设备
CN106714733A (zh) * 2014-09-15 2017-05-24 W.L.戈尔及同仁股份有限公司 带有保持元件的假体心脏瓣膜
CN107106294A (zh) * 2014-12-18 2017-08-29 W.L.戈尔及同仁股份有限公司 带有机械联接的瓣叶的假体瓣膜
CN109925094A (zh) * 2017-12-18 2019-06-25 先健科技(深圳)有限公司 人工心脏瓣膜

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6461382B1 (en) * 2000-09-22 2002-10-08 Edwards Lifesciences Corporation Flexible heart valve having moveable commissures
CN106456322A (zh) * 2014-03-11 2017-02-22 爱普贡公司 人工单瓣叶瓣膜及输送设备
CN106714733A (zh) * 2014-09-15 2017-05-24 W.L.戈尔及同仁股份有限公司 带有保持元件的假体心脏瓣膜
CN107106294A (zh) * 2014-12-18 2017-08-29 W.L.戈尔及同仁股份有限公司 带有机械联接的瓣叶的假体瓣膜
CN109925094A (zh) * 2017-12-18 2019-06-25 先健科技(深圳)有限公司 人工心脏瓣膜

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