WO2023050788A1 - 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
WO2023050788A1
WO2023050788A1 PCT/CN2022/089329 CN2022089329W WO2023050788A1 WO 2023050788 A1 WO2023050788 A1 WO 2023050788A1 CN 2022089329 W CN2022089329 W CN 2022089329W WO 2023050788 A1 WO2023050788 A1 WO 2023050788A1
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WO
WIPO (PCT)
Prior art keywords
heart valve
artificial heart
outflow end
connection
stent
Prior art date
Application number
PCT/CN2022/089329
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English (en)
French (fr)
Inventor
吴明明
吴意
王春光
陈大凯
Original Assignee
科凯(南通)生命科学有限公司
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Application filed by 科凯(南通)生命科学有限公司 filed Critical 科凯(南通)生命科学有限公司
Publication of WO2023050788A1 publication Critical patent/WO2023050788A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets

Definitions

  • the invention relates to the technical field of medical devices, in particular to an artificial heart valve.
  • Cardiovascular disease is the number one health killer worldwide. At present, there are nearly 300 million patients with cardiovascular diseases in my country. According to incomplete statistics, about 10,000 people die from cardiovascular diseases every year, accounting for 45% of the total number of deaths from all diseases.
  • Heart valve disease is a very common heart disease in my country, and among them, valve damage caused by rheumatic fever is the most common.
  • senile valvular disease, coronary heart disease, and heart valvular disease caused by myocardial infarction are becoming more and more common.
  • the incidence rate of valvular heart disease in my country is 2.5%-3.2%, and the incidence rate of valvular heart disease among the elderly over 75 years old is as high as 13.3%.
  • Mild valvular heart disease can be treated with drugs, but for severe valvular heart disease, only surgery can be used to replace the heart valve.
  • transcatheter aortic replacement also known as TAVR replacement
  • TAVR replacement transcatheter aortic replacement
  • It mainly pre-presses the artificial heart valve, punctures the femoral artery or other suitable blood vessels, and uses the delivery system to deliver the artificial heart valve to the diseased aortic valve.
  • the delivery system uses the delivery system to deliver the artificial heart valve to the diseased aortic valve.
  • move the crimped artificial heart valve onto the balloon inject high-pressure liquid or gas into the balloon to expand the balloon, and drive the valve to expand, so as to complete the placement of the artificial heart valve.
  • It belongs to minimally invasive surgery, with less surgical trauma, short operation process and quick postoperative recovery.
  • the present application provides an artificial heart valve.
  • the artificial heart valve can avoid the artificial heart valve having a bone-like structure with two thick ends and a thin middle part, and it can also prevent the balloon from being damaged due to uneven force during the expansion process.
  • the artificial heart valve can achieve more uniform compression and contraction.
  • the artificial heart valve greatly improves the safety of use without significantly increasing the cost, and provides stronger support for the health of patients. It has the advantages of good use effect and rich application scenarios, and has huge market potential.
  • the artificial heart valve includes a plurality of leaflets and an artificial heart valve support, and the leaflets are connected to the artificial heart valve support.
  • the stent is an annular stent capable of shrinking and expanding radially, and the stent includes an inflow end and an outflow end.
  • the inflow end includes a plurality of interconnected inflow end frame units and a plurality of inflow end connection areas, the plurality of interconnected inflow end frame units are gyro-shaped hollow frame units, and the inflow end connection areas are two adjacent inflow end frames The area where units are connected to each other.
  • the frame unit at the inflow end includes a first protruding portion and a second protruding portion, the first protruding portion protrudes toward the outflow end along the axial direction of the bracket, and the second protruding portion protrudes along the axial direction of the bracket
  • the direction is convex, and the vertical distance between the first protrusion and the line connecting the two adjacent inflow end connection areas is less than or equal to the vertical distance between the second protrusion and the line connecting the two adjacent inflow end connection areas.
  • the outflow end includes a plurality of interconnected outflow end frame units and a plurality of outflow end connection areas, the plurality of interconnected outflow end frame units are hexagonal hollow frame units, and the outflow end connection areas are two adjacent outflow end The area where frame elements are connected to each other.
  • the frame unit at the inflow end further includes a first connection portion and a second connection portion, the first connection portion is located between the first raised portion and the connection area of the inflow end, and the second connection portion is located at the second raised portion and the inflow connection area.
  • the width of the connection area of the inflow end along the circumferential direction of the stent is greater than twice the average value of the widths of the first connecting portion and the second connecting portion along the circumferential direction of the stent.
  • the length of the connection region of the inflow end along the axial direction of the stent is 1 to 3 times the average width of the first connecting portion and the second connecting portion along the circumferential direction of the stent.
  • the ratio of the distance between two adjacent inflow-end connection regions to the distance between the first protrusion and the second protrusion of the inflow-end frame unit is 0.8 ⁇ 1.
  • the inner top of the first raised portion, the inner top of the second raised portion and/or the outer top of the second raised portion is arc-shaped or elliptical.
  • the width of the connection area of the outflow end along the circumferential direction of the stent is smaller than the width of the connection area of the inflow end along the circumferential direction of the stent.
  • the outflow end frame unit includes a third protruding portion and a fourth protruding portion, the third protruding portion protrudes toward the outflow end along the axial direction of the bracket, and the fourth protruding portion protrudes along the axis of the bracket Projecting in a direction away from the outflow end.
  • the frame unit at the outflow end further includes a third connection part and a fourth connection part, the third connection part is located between the third protrusion and the connection area of the outflow end, and the fourth connection part is located between the fourth protrusion and the connection area of the outflow end between.
  • the inner top of the third raised portion, the outer top of the third raised portion and/or the inner top of the fourth raised portion is arc-shaped or elliptical.
  • between two adjacent third connection parts between two adjacent fourth connection parts, between a third connection part and adjacent outflow end connection areas and/or the fourth connection
  • the circular arc connection between the head and the adjacent outflow end connection area between two adjacent third connection parts, between two adjacent fourth connection parts, between a third connection part and adjacent outflow end connection areas and/or the fourth connection.
  • At least one outflow end connection area is provided with a suture part, and the suture part is a sheet-like structure with a wide middle and narrow ends arranged along the axial direction of the stent.
  • the third connecting portion and the adjacent sewing portion and/or the fourth connecting portion and the adjacent sewing portion are connected in an arc.
  • the bracket further includes a transition section disposed between the inflow end and the outflow end, the transition section includes a plurality of interconnected transition section frame units and a plurality of transition section connection areas, and a plurality of interconnected transition section frames
  • the unit is a gyro-shaped hollow frame unit, and the connection area of the transition section is the area where two adjacent transition section frame units are connected to each other.
  • the frame unit of the transition section includes a fifth protruding portion and a sixth protruding portion, the fifth protruding portion protrudes toward the direction of the outflow end along the axial direction of the bracket, and the sixth protruding portion protrudes toward a direction away from the outflow end along the axial direction of the bracket The direction is convex.
  • the vertical distance between the fifth protrusion and the line connecting the two adjacent transition sections is equal to the vertical distance between the sixth protrusion and the line connecting the two adjacent transition sections.
  • the ratio between the distance between the connecting regions of two adjacent transition sections and the distance between the fifth protrusion and the sixth protrusion is greater than 1.
  • the frame unit of the transition section further includes a fifth connecting portion and a sixth connecting portion, the fifth connecting portion is located between the fifth raised portion and the connecting area of the transition section, and the sixth connecting portion is located at the sixth raised portion and the transition section connecting the regions.
  • the ratio of the length of the connecting region of the transition section along the axial direction of the stent to the average width of the fifth connecting portion and the sixth connecting portion along the circumferential direction of the stent is 0.8-1.3.
  • the ratio of the length of the connecting region of the transition section along the axial direction of the stent to the average width of the fifth connecting portion and the sixth connecting portion along the circumferential direction of the stent is 1 ⁇ 1.1.
  • the leaflet includes: a tail part of the leaflet, and the outer side of the tail part of the leaflet is a protruding structure, and the outer edge of the protruding structure is connected with the artificial heart valve support.
  • Sealing strip the sealing strip is a bendable structure, the outer side of the sealing strip is connected to the inner side of the tail of the valve leaflet, the side where the inner side is located is perpendicular to the plane where the tail of the valve leaflet is located, and the other two opposite sides of the sealing strip are respectively provided with fixed ends, fixed The end is folded and wrapped with clips to form a fixing part, which is fixedly connected with the artificial heart valve bracket through the fixing part.
  • Two adjacent valve leaflets are sequentially connected by a fixing member to form a valve body, and the ends of the inner surfaces of the sealing strips in the two adjacent valve leaflets are in contact so that the middle part of the valve body can be opened and closed in one direction.
  • the artificial heart valve further includes a first suture film, which is sutured to all the frame units at the inflow end of the artificial heart valve stent and completely covers the hollow area of the frame unit at the inflow end.
  • the artificial heart valve further includes an outer skirt, one end of the outer skirt includes a sawtooth structure, the sawtooth structure matches the shape of the inflow end of the artificial heart valve support, and is sutured and fixed with the artificial heart valve support.
  • the protruding structure outside the caudal part of the leaflet is an inner skirt fixed on the outer side of the caudal part by suturing, and the inner skirt matches the shape of the outer edge of the caudal part of the leaflet.
  • Fig. 1 is the structural representation of a kind of artificial heart valve in one embodiment of the present application
  • Fig. 2 is the expanded structure schematic diagram of a kind of four-layer artificial heart valve support in an embodiment as shown in Fig. 1;
  • Fig. 3 is the three-dimensional structure schematic diagram of a kind of four-layer artificial heart valve support in an embodiment as shown in Fig. 2;
  • Fig. 4 is the front view of a kind of four-layer artificial heart valve support in an embodiment as shown in Fig. 2;
  • Fig. 5 is the partially enlarged schematic view of the inflow end of the artificial heart valve support in an embodiment as shown in Fig. 2;
  • Fig. 6 is the partially enlarged schematic diagram of the outflow end of the artificial heart valve support in an embodiment as shown in Fig. 2;
  • Fig. 7 is the partially enlarged schematic view of the A region of the outflow end of the artificial heart valve support in an embodiment as shown in Fig. 6;
  • Fig. 8 is the partially enlarged schematic view of the B area of the outflow end of the artificial heart valve support in an embodiment as shown in Fig. 6;
  • Fig. 9 is a partially enlarged schematic view of the transition section of the artificial heart valve support in an embodiment as shown in Fig. 2;
  • Fig. 10 is a structural schematic diagram of the crimping state of a kind of artificial heart valve support in an embodiment as shown in Fig. 2;
  • Fig. 11 is the schematic diagram of the gyroscopic hollow frame unit of the inflow end of a kind of artificial heart valve support in an embodiment as shown in Fig. 2;
  • Figure 12 is a schematic diagram of the unfolded structure of a four-layer artificial heart valve stent in an embodiment of the present application
  • Figure 13 is a schematic diagram of the unfolded structure of a three-layer artificial heart valve stent in an embodiment of the present application
  • Fig. 14 is a schematic diagram of the installation structure of multiple leaflets in an embodiment as shown in Fig. 1;
  • Fig. 15 is a schematic structural view of the valve leaflet in an embodiment as shown in Fig. 1;
  • Fig. 16 is a schematic structural view of the clip in an embodiment as shown in Fig. 1;
  • Fig. 17 is a schematic diagram of the relative positions of the clip and the valve leaflet in an embodiment as shown in Fig. 1;
  • Fig. 18 is a schematic structural view of another valve leaflet in an embodiment as shown in Fig. 1;
  • Fig. 19 is a schematic structural view of the first suture film in an embodiment as shown in Fig. 1;
  • Figure 20 is a schematic structural view of the outer skirt in an embodiment as shown in Figure 1;
  • Fig. 21 is a schematic structural view of the inner skirt in an embodiment as shown in Fig. 1 .
  • first”, “second”, etc. are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features.
  • a feature defined as “first”, “second”, etc. may expressly or implicitly include one or more of that feature.
  • “plurality” means two or more.
  • connection should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention based on specific situations.
  • the embodiment of the present application relates to an artificial heart valve as shown in FIG.
  • the brackets 200 are connected.
  • the prosthetic heart valve stent 200 is an annular stent capable of radial contraction and expansion, and the prosthetic heart valve stent 200 includes an inflow end 210 and an outflow end 220 .
  • the inflow end 210 as shown in Figure 5 comprises a plurality of interconnected inflow end frame units 211 and a plurality of inflow end connection regions 212, and a plurality of interconnected inflow end frame units 211 are gyroscope-shaped hollow frame units, and the inflow end connections
  • the area 212 is an area where two adjacent inflow end frame units 211 are connected to each other.
  • the inflow end frame unit 211 includes a first protruding portion 213 and a second protruding portion 214. The first protruding portion 213 protrudes toward the outflow end 220 along the axial direction of the bracket, and the second protruding portion 214 protrudes along the axial direction of the bracket.
  • the axial direction protrudes toward the direction away from the outflow end 220, and the vertical distance between the first protrusion 213 and the line connecting the two adjacent inflow end connection areas 212 is less than or equal to the second protrusion 214 and the two adjacent The vertical distance between the lines connecting the two inflow end connection areas 212.
  • the annular inner contour of the top-shaped hollow frame unit is as shown in FIG. 11 .
  • the annular internal profile of the gyro-shaped hollow frame unit can be connected smoothly by the first straight line AB, the first quadratic curve BC, the second straight line CD, the second quadratic curve DE, the third straight line EF, the third straight line It is composed of a quadratic curve FG, a fourth straight line GH and a fourth quadratic curve HA.
  • the length of the first straight line AB is equal to that of the second straight line CD
  • the length of the third straight line EF is equal to that of the fourth straight line GH.
  • the length of the first straight line AB or the second straight line CD is greater than or equal to the lengths of the third straight line EF and the third straight line GH.
  • the first conic curve BC is a parabola convex toward the direction of the outflow end 220 and includes a maximum value P1.
  • the third quadratic curve FG is a parabola protruding away from the outflow end 220 and includes a maximum value P3.
  • the parabolic opening of the first quadratic curve BC is less than or equal to the parabolic opening of the third quadratic curve FG.
  • the second quadratic curve DE is an arc protruding outward in the circumferential direction away from the longitudinal axis of the frame unit 211 at the inflow end, and includes a maximum value P2.
  • the fourth quadratic curve HA is an arc protruding outward in the circumferential direction away from the longitudinal axis of the frame unit 211 at the inflow end, and includes a maximum value P4.
  • the second quadratic curve DE and the fourth quadratic curve HA are symmetrical to each other.
  • the maximum values P2 and P4 are on the same horizontal height, and the vertical distance from the maximum value P1 to the horizontal height is greater than or equal to the vertical distance from the maximum value P3 to the horizontal height.
  • the vertical distance from the maximum value P1 to the horizontal height may be 1-2.5 times the vertical distance from the maximum value P3 to the horizontal height.
  • the length of the frame profile formed by P4-P1-P2 extending along the longitudinal axis of the inflow end frame unit 211 is greater than or equal to the length of the frame profile formed by P4-P3-P2 extending along the longitudinal axis of the inflow end frame unit 211. length.
  • the outflow end 220 as shown in Figure 6 comprises a plurality of interconnected outflow end frame units 221 and a plurality of outflow end connection areas 222, and a plurality of interconnected outflow end frame units 221 are hexagonal hollow frame units, and the outflow end
  • the connection area 222 is an area where two adjacent outflow end frame units 221 are connected to each other.
  • the inflow end frame unit 211 further includes a first connection portion 215 and a second connection portion 216, the first connection portion 215 is located between the first raised portion 213 and the inflow end connection area 212, and the second connection portion 216 is located between the second projection 214 and the inflow connection region 212 .
  • the width of the inflow end connecting region 212 along the circumferential direction of the stent is greater than twice the average value of the widths of the first connecting portion 215 and the second connecting portion 216 along the circumferential direction of the stent.
  • the length of the inflow end connecting region 212 along the axial direction of the stent is 1 to 3 times the average width of the first connecting portion 215 and the second connecting portion 216 along the circumferential direction of the stent.
  • it may be 1 times, 1.2 times, 1.5 times, 1.6 times, 1.8 times, 2 times, 2.2 times, 2.5 times, 2.6 times, 2.8 times or 3 times.
  • the ratio of the distance between two adjacent inflow-end connection areas 212 to the distance between the first protrusion 213 and the second protrusion 214 of the inflow-end frame unit 211 is 0.8-1 , for example, could be 0.9.
  • the remaining part of the inflow end 210 outside the inflow end connecting region 212 has the same width.
  • the inner top of the first raised portion 213 , the inner top of the second raised portion 214 and/or the outer top of the second raised portion 214 are arc-shaped or elliptical.
  • the top inner side of the first raised portion 213, the top inner side of the second raised portion 214 and/or the top outer side of the second raised portion 214 may be in the shape of an arc of 130°-150° , for example, can be 130°, 140° or 150°.
  • the width of the outflow end connection area 222 along the circumferential direction of the stent is smaller than the width of the inflow end connection area 212 along the circumferential direction of the stent.
  • the width of the outflow end connection area 222 along the circumferential direction of the stent is less than half of the width of the inflow end connection area 212 along the circumferential direction of the stent.
  • two adjacent outflow end frame units 221 may share a side as the outflow end connection area 222 .
  • the outflow end frame unit 221 includes a third protruding portion 223 and a fourth protruding portion 224, the third protruding portion 223 protrudes toward the outflow end 220 along the axial direction of the bracket, and the fourth protruding portion
  • the raised portion 224 protrudes away from the outflow end 220 along the axial direction of the bracket.
  • the outflow end frame unit 221 also includes a third connection part 225 and a fourth connection part 226, the third connection part 225 is located between the third protrusion part 223 and the outflow end connection area 222, and the fourth connection part 226 is located in the fourth protrusion Between the part 224 and the outflow end connection area 222.
  • the inside of the top of the third protrusion 223 , the outside of the top of the third protrusion 223 and/or the inside of the top of the fourth protrusion 224 are arc-shaped or elliptical.
  • the inner top of the third raised portion 223, the outer top of the third raised portion 223 and/or the inner top of the fourth raised portion 224 may be in the shape of an arc of 130°-150° , for example, can be 130°, 140° or 150°.
  • a partially enlarged view of the third raised portion 223 is shown in FIG. 7 .
  • the design of the third raised portion 223 in a circular or elliptical arc shape can prevent the third raised portion 223 from being crimped during delivery or expansion. After contacting and clamping the balloon, the balloon will be broken due to uneven force during the expansion process, and it can also prevent the stent from being unable to expand smoothly due to excessive compression.
  • between two adjacent third connection parts 225, between two adjacent fourth connection parts 226, between the third connection part 225 and the adjacent outflow end connection area 222 and/or Or the fourth connecting portion 226 is connected to the adjacent outflow end connecting region 222 in an arc.
  • the angle of the arc may be 130°-150°, for example, 130°, 140° or 150°.
  • the circular arc connection between two adjacent third connection parts 225 and between the third connection part 225 and the adjacent outflow end connection area 222 may be as shown in FIG. 8 .
  • the remaining portion of the outflow end 220 outside the outflow end connecting region 222 has the same width.
  • the prosthetic heart valve stent 200 can be in a symmetrical and uniform crimping state as shown in FIG.
  • the abnormal state that is, the asymmetrical pressure grip.
  • At least one outflow end connection area 222 is provided with a suture part 227, and the suture part 227 is a sheet-like structure with a wide middle and narrow ends arranged along the axial direction of the stent.
  • at least two sewing holes 228 are provided on the sewing portion 227 .
  • the third connecting portion 225 and the adjacent sewing portion 227 and/or the fourth connecting portion 226 and the adjacent sewing portion 227 are connected in an arc.
  • the angle of the arc may be 130°-150°, for example, 130°, 140° or 150°.
  • the bracket further includes a transition section 230 as shown in FIG. 9 disposed between the inflow end 210 and the outflow end 220.
  • the transition section 230 includes a plurality of interconnected transition section frame units 231 and a plurality of transition sections.
  • the connection area 232 the plurality of interconnected transition section frame units 231 are top-shaped hollow frame units, and the transition section connection area 232 is an area where two adjacent transition section frame units 231 are connected to each other.
  • the bracket may further include single, double or multiple rows of interconnected transition section frame units 231 and transition section connection areas 232 .
  • the transition section frame unit 231 includes a fifth protruding portion 233 and a sixth protruding portion 234.
  • the fifth protruding portion 233 protrudes toward the outflow end 220 along the axial direction of the bracket, and the sixth protruding portion 234 protrudes along the axial direction of the bracket.
  • the axial direction protrudes in a direction away from the outflow end 220 .
  • the vertical distance between the fifth protruding portion 233 and the connecting area 232 of two adjacent transition sections is equal to the distance between the sixth protruding portion 234 and the connecting area 232 of two adjacent transition sections.
  • the vertical distance of the line is equal to the distance between the sixth protruding portion 234 and the connecting area 232 of two adjacent transition sections.
  • the ratio of the distance between the connecting regions 232 of two adjacent transition sections to the distance between the fifth raised portion 233 and the sixth raised portion 234 is greater than 1.
  • the ratio of the distance between the connecting regions 232 of two adjacent transition sections to the distance between the fifth raised portion 233 and the sixth raised portion 234 is greater than 1.2.
  • the transition section frame unit 231 further includes a fifth connection part 235 and a sixth connection part 236, the fifth connection part 235 is located between the fifth raised part 233 and the transition section connection area 232, and the sixth connection part 236 is located between the sixth raised portion 234 and the transition section connection area 232 .
  • the bracket when the bracket includes a single row of transition section frame units 231 and a transition section connection area 232, the fifth connection portion 235 coincides with the fourth connection portion 226 of the outflow end 220, and the sixth connection portion 236 coincides with the inflow end.
  • the first connecting portion 215 of 210 overlaps.
  • the ratio of the length of the transition section connecting region 232 along the axial direction of the stent to the average width of the fifth connecting portion 235 and the sixth connecting portion 236 along the circumferential direction of the stent is 0.8 ⁇ 1.3.
  • the ratio of the length of the transition section connecting region 232 along the axial direction of the stent to the average width of the fifth connecting portion 235 and the sixth connecting portion 236 along the circumferential direction of the stent is 1-1.1. If the connecting area 232 of the transition section is too long, the transition section 230 is not easy to expand, and the diameter of the two ends of the stent is large and the transition section is small.
  • the expansion performance of the transition section 230 can be guaranteed, and the operation safety and reliability can be improved.
  • the embodiment of the present application also relates to an artificial heart valve stent as shown in FIG. 12 .
  • the artificial heart valve stent 600 includes an inflow end 610 , an outflow end 620 , and a transition section 630 comprising a double-layer transition section frame unit and a transition section connection area.
  • the structure of the artificial heart valve stent 600 may be similar to that of the artificial heart valve stent 200 described in FIGS. 1 to 11 .
  • the embodiment of the present application also relates to an artificial heart valve stent as shown in FIG. 13 .
  • the artificial heart valve stent 700 includes an inflow end 710, an outflow end 720, and a transition section 730 comprising a single-layer transition section frame unit and a transition section connection area.
  • the structure of the artificial heart valve stent 700 may be similar to that of the artificial heart valve stent 200 described in FIGS. 1 to 11 .
  • a plurality of leaflets 100 as shown in Figure 15 are sequentially connected to form a valve body 110 whose outer circumference is a ring structure, and the valve body 110 and the artificial heart valve support
  • the inner wall of the valve body 200 is fixedly connected, and the middle part of the valve body 110 can be opened and closed in one direction.
  • a plurality of valve leaflets 100 for example, three valve leaflets 100, forms a ring-shaped valve body 110, which has a function similar to that of a "one-way valve".
  • the leaflets 100 shown in FIG. 15 each include a leaflet tail 121 , a sealing strip 122 and a fixing member 123 .
  • the outer side of the leaflet tail 121 is a protruding structure, and the outer edge of the protruding structure is connected with the artificial heart valve support 200 , specifically, the outer edge of the protruding structure can be connected with the inner wall of the artificial heart valve support 200 .
  • the sealing strip 122 is a bendable structure, the outer side of the sealing strip 122 is connected to the inner side of the leaflet tail 121, the inner side of the sealing strip 122 is perpendicular to the plane where the leaflet tail 121 is located, and the other two opposite sides of the sealing strip 122 are respectively
  • a fixed end 124 is provided, and the fixed end 124 is folded and wrapped with a clip 125 to form a fixing part 123 , which is fixedly connected with the artificial heart valve support 200 through the fixing part 123 .
  • FIG. 15 it is the valve leaflet 100 in the unbent state of the sealing strip 122 , and the fixed ends 124 are formed by extending outward on the left and right sides of the sealing strip 122 .
  • the thickness of clip 125 as shown in Figure 16 is preferably 0.1 millimeter-0.5 millimeter, and clip 125 is provided with at least one clip sewing hole 126, through clip sewing hole 126, fixed end 124 is sutured through suture thread and wrapped clip Tablet 125.
  • the leaflet may also be shown in FIG. 18 , and the leaflet includes a leaflet main body 131 , a sealing strip 132 and a fixing member.
  • the outer edge of the leaflet body 131 is connected with the inner wall of the artificial heart valve support 200 .
  • the sealing strip 132 is a bendable structure, the outer side of the sealing strip 132 is connected to the inner side of the leaflet body 131 , and the inner side of the sealing strip 132 is perpendicular to the plane where the leaflet body 131 is located.
  • the other two opposite sides of the sealing strip 132 are respectively provided with fixed ends 134 , and the fixed ends 134 are turned over and wrapped with clips to form a fixing piece, and are fixedly connected with the artificial heart valve support 200 through the fixing piece.
  • two adjacent valve leaflets 100 are sequentially connected to form a valve body 110 through the fixing member 123 through the suturing hole 126 of the clip to form a valve body 110 , and the ends of the inner surfaces of the sealing strips 122 in the two adjacent valve leaflets 100 are in contact with each other.
  • the central part of the valve body 110 can be opened and closed in one direction.
  • a plurality of valve leaflets 100 are fixedly connected with the artificial heart valve support 200 by the fixture 123, they are also sewed with the artificial heart valve support 200 through the clip suture holes 126 to realize connection and fixation.
  • fixing the plurality of valve leaflets 100 It is fixed in the artificial heart valve stent 200 along the direction of blood flow.
  • the mitral valve device designed in the present invention is designed as a plurality of leaflets 100, and the plurality of leaflets 100 are fixed by clips 125 to form a fixture 123, and then
  • the way of suturing into the artificial heart valve stent 200 enhances the strength and stability of the axial valve leaflet 100, and changes the point contact between the leaflet 100 and the artificial heart valve stent 200 into a line contact, reducing the flow of blood.
  • the tension of the partial leaflets 100, especially the distal leaflets 100 makes the structure more stable.
  • the way of longitudinal stitching ensures its "one-way valve" function and effectively improves its bearing capacity against reverse pressure.
  • the artificial heart valve further includes a first suture film 300 as shown in FIG. 19
  • the first suture film 300 may be a polymer film.
  • the first suture film 300 may be sutured to all the frame units 211 at the inflow end of the prosthetic heart valve stent 200 , and completely cover the hollow portion of the frame unit 211 at the inflow end.
  • the first seaming film 300 can also be sewn with at least part of the frame unit 231 of the transition section, and completely cover the hollow part of the frame unit 231 of the transition section.
  • the first suturing film 300 can prevent paravalvular leakage and avoid blocking the coronary artery.
  • the first suture film can cover all the inflow end frame units of the fourth layer, all the transition section frame units of the third layer and part of the transition section frame units of the second layer .
  • the first seamed membrane may cover the transition section frame elements of the second layer at intervals.
  • the first suture film may cover all the frame units at the inflow end of the third layer and part of the frame units at the transition section of the second layer.
  • the first seamed membrane may cover the transition section frame elements of the second layer at intervals.
  • the artificial heart valve further includes an outer skirt 400 as shown in FIG.
  • One end of the outer skirt 400 includes a sawtooth structure, which can match the shape of the inflow end 210 of the artificial heart valve support 200, and is sutured and fixed with the artificial heart valve support 200.
  • the sawtooth structure can be connected to the artificial heart valve support.
  • the second protruding part 214 and the second connecting part 216 of the valve support 200 are sutured and fixed.
  • Outer skirt 400 may be used to prevent paravalvular leaks.
  • the artificial heart valve further includes an inner skirt 500 as shown in FIG. 21 .
  • the protruding structure on the outside of the leaflet tail 121 is an inner skirt 500 fixed on the outside of the leaflet tail 121 by suturing.
  • the inner skirt 500 matches the shape of the outer edge of the leaflet tail 121 .
  • the inner skirt 500 can be a polymer film, and the inner skirt 500 can be used to prevent paravalvular leakage.

Abstract

本发明一方面在于提供一种人工心脏瓣膜，包括多片瓣叶和人工心脏瓣膜支架，瓣叶与人工心脏瓣膜支架相连。支架为可径向收缩及扩张的环形支架，支架包括流入端和流出端。流入端包括多个相互连接的流入端框架单元和多个流入端连接区域，多个相互连接的流入端框架单元为陀螺形的中空框架单元。流出端包括多个相互连接的流出端框架单元和多个流出端连接区域，多个相互连接的流出端框架单元为六边形的中空框架单元。该人工心脏瓣膜在不显著增加成本的情况下大幅提升使用安全性，为患者的身体健康提供更加强有力的支持，其具有使用效果好、适用场景丰富等优点，具有巨大的市场潜力。

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，具体涉及一种人工心脏瓣膜。
背景技术
心血管疾病是世界范围内的头号健康杀手。目前，我国的心血管疾病患者已接近3亿人。据不完全统计，每年约有万人因心血管疾病而死亡，占所有疾病致死总人数的45％。
临床上，常见的心血管疾病主要包括冠心病和心脏瓣膜疾病。而心脏瓣膜疾病是我国非常常见的一种心脏疾病，其中，以风湿热导致的瓣膜损害最为常见。随着人口老龄化日益加重，老年性瓣膜病以及冠心病、心肌梗死后引起的心脏瓣膜疾病变也越来越常见。
据流行病学的调查统计，我国心脏瓣膜病的发病率为2.5％-3.2％，其中，超过75岁的老年人的瓣膜性心脏病的发病率高达13.3％。对于症状轻微的瓣膜性心脏病可以采用药物治疗，但是，对于重度的瓣膜性心脏病，只能采取手术的办法更换心脏瓣膜。
传统的更换心脏瓣膜的外科手术需要进行开胸，同时使患者心脏停跳，并建立体外循环系统。此类手术方式创伤大、后期恢复时间长，不是所有的患者，尤其是老年患者，可以耐受的。
目前，经导管主动脉置换术，又称TAVR置换术，已成为心血管疾病治疗最为有效的手段和主流趋势。其主要是将人工心脏瓣膜预先压握，通过在股动脉或其他合适的血管上穿刺，并利用输送系统将人工心脏瓣膜输送到病变的主动脉瓣处，在人工心脏瓣膜被输送到目标位置后，将压握后的人工心脏瓣膜移动到球囊上，向球囊中打入高压液体或气体使球囊扩充，并带动瓣膜膨胀，以完成人工心脏瓣膜的放置。其属于微创手术，手术创伤小，手术过程短，术后恢复快。
但是，在实际过程中，常常会发现现有的人工心脏瓣膜存在使用上的困难。例如，由于通常在使用过程中，人工心脏瓣膜的两端受到的压力较小，因此，其膨胀通常从两端开始并逐渐带动中部膨胀，在一些情况下，会出现两头粗中部细的骨头状结构。此外，在一些情形下，在人工心脏瓣膜输送或膨胀过程中，其帽端两边的斜支撑杆经压握后接触并夹住球囊，致使球囊在后面的膨胀过程中因受力不均匀而破裂。另外，在使用过程中，也发现在压握时存在其他部分已压握完成的情况下，缝合部分仍然保持竖直状态而出现压握不对称的情况。
因此，急需一种新技术来解决上述问题。
发明内容
为弥补现有技术的不足，本申请提供一种人工心脏瓣膜。该人工心脏瓣膜通过使用本申请涉及流入端、流出端和其他部分的独特设计可以避免人工心脏瓣膜出现两头粗中部细的骨头状结构，也可以避免球囊在膨胀过程中因受力不均匀而破裂的情况，同时，在压握状态下，人工心脏瓣膜可以实现更为均匀的受压收缩。此外，该人工心脏瓣膜在不显著增加成本的情况下大幅提升使用安全性，为患者的身体健康提供更加强有力的支持，其具有使用效果好、适用场景丰富等优点，具有巨大的市场潜力。
本申请一方面在于提供一种人工心脏瓣膜，人工心脏瓣膜包括多片瓣叶和人工心脏瓣膜支架，瓣叶与人工心脏瓣膜支架相连。支架为可径向收缩及扩张的环形支架，支架包括流入端和流出端。流入端包括多个相互连接的流入端框架单元和多个流入端连接区域，多个相互连接的流入端框架单元为陀螺形的中空框架单元，流入端连接区域为相邻的两个流入端框架单元相互连接的区域。流入端框架单元包括第一凸起部和第二凸起部，第一凸起部沿支架的轴向方向朝流出端的方向凸出，第二凸起部沿支架的轴向方向朝远离流出端的方向凸出，第一凸起部与相邻的两个流入端连接区域的连线的垂直距离小于或等于第二凸起部与相邻的两个流入端连接区域的连线的垂直距离。流出端包括多个相互连接的流出端框架单元和多个流出端连接区域，多个相互连接的流出端框架单元为六边形的中空框架单元，流出端连接区域为相邻的两个流出端框架单元相互连接的区域。
在一些实施例中，流入端框架单元还包括第一连接部和第二连接部，第一连接部位于第一凸起部和流入端连接区域之间，第二连接部位于第二凸起部和流入端连接区域之间。流入端连接区域沿支架周向上的宽度大于第一连接部和第二连接部沿支架周向上的宽度的平均值的2倍。
在一些实施例中，流入端连接区域沿支架轴向上的长度为第一连接部和第二连接部沿支架周向上的宽度的平均值的1倍至3倍。
在一些实施例中，相邻的两个流入端连接区域之间的距离与流入端框架单元的第一凸起部和第二凸起部之间的距离的比值为0.8～1。
在一些实施例中，第一凸起部的顶部内侧、第二凸起部的顶部内侧和/或第二凸起部的顶部外侧为圆弧形或椭圆弧形。
在一些实施例中，流出端连接区域沿支架周向上的宽度小于流入端连接区域沿支架周向上的宽度。
在一些实施例中，流出端框架单元包括第三凸起部和第四凸起部，第三凸起部沿支架的轴向方向朝流出端的方向凸出，第四凸起部沿支架的轴向方向朝远离流出端的方向凸出。流出端框架单元还包括第三连接部和第四连接部，第三连接部位于第三凸起部和流出端连接区域之间，第四连接部位于第四凸起部和流出端连接区域之间。
在一些实施例中，第三凸起部的顶部内侧、第三凸起部的顶部外侧和/或第四凸起部的顶部内侧为圆弧形或椭圆弧形。
在一些实施例中，相邻的两个第三连接部之间、相邻的两个第四连接部之间、第三连接部和相邻的流出端连接区域之间和/或第四连接部和相邻的流出端连接区域之间圆弧连接。
在一些实施例中，至少一个流出端连接区域上设有缝合部，缝合部为沿支架的轴向方向设置的中间宽两端窄的片状结构。
在一些实施例中，第三连接部和相邻的缝合部之间和/或第四连接部和相邻的缝合部之间圆弧连接。
在一些实施例中，支架进一步包括设置于流入端和流出端之间的过渡段，过渡段包括多个相互连接的过渡段框架单元和多个过渡段连接区域，多个相互连接的过渡段框架单元为陀螺形的中空框架单元，过渡段连接区域为相邻的两个过渡段框架单元相互连接的区域。过 渡段框架单元包括第五凸起部和第六凸起部，第五凸起部沿支架的轴向方向朝流出端的方向凸出，第六凸起部沿支架的轴向方向朝远离流出端的方向凸出。
在一些实施例中，第五凸起部与相邻的两个过渡段连接区域的连线的垂直距离等于第六凸起部与相邻的两个过渡段连接区域的连线的垂直距离。
在一些实施例中，相邻的两个过渡段连接区域之间的距离与第五凸起部和第六凸起部之间的距离之间的比值大于1。
在一些实施例中，过渡段框架单元还包括第五连接部和第六连接部，第五连接部位于第五凸起部和过渡段连接区域之间，第六连接部位于第六凸起部和过渡段连接区域之间。过渡段连接区域沿支架轴向上的长度与第五连接部和第六连接部沿支架周向上的宽度的平均值的比值为0.8～1.3。
在一些实施例中，过渡段连接区域沿支架轴向上的长度与第五连接部和第六连接部沿支架周向上的宽度的平均值的比值为1～1.1。
在一些实施例中，瓣叶包括：瓣叶尾部，瓣叶尾部的外侧为突出结构，突出结构的外侧边缘与人工心脏瓣膜支架相连。密封条，密封条为可弯折结构，密封条的外侧连接瓣叶尾部的内侧，内侧所在的侧面与瓣叶尾部所在的平面垂直，密封条的另两个对侧面分别设置有固定端，固定端翻折并包裹有夹片后形成固定件，通过固定件与人工心脏瓣膜支架固定连接。相邻两个瓣叶通过固定件依次连接形成瓣膜体，相邻两个瓣叶中的密封条内侧面端部接触以实现瓣膜体的中部可单向开合。
在一些实施例中，人工心脏瓣膜进一步包括第一缝合膜，第一缝合膜与人工心脏瓣膜支架的全部流入端框架单元缝合，并将流入端框架单元的中空区域完全覆盖。
在一些实施例中，人工心脏瓣膜进一步包括外裙边，外裙边的一端包括锯齿状结构，锯齿状结构与人工心脏瓣膜支架的流入端的形状相匹配，并与人工心脏瓣膜支架缝合固定。
在一些实施例中，瓣叶尾部外侧的突出结构为缝合固定在瓣叶尾部外侧的内裙边，内裙边与瓣叶尾部外侧边缘的形状相匹配。
附图说明
通过结合附图对于本申请的实施方式进行描述，可以更好地理解本申请，在附图中：
图1为本申请的一个实施例中的一种人工心脏瓣膜的结构示意图；
图2为如图1所示的一个实施例中的一种四层人工心脏瓣膜支架的展开结构示意图；
图3为如图2所示的一个实施例中的一种四层人工心脏瓣膜支架的立体结构示意图；
图4为如图2所示的一个实施例中的一种四层人工心脏瓣膜支架的主视图；
图5为如图2所示的一个实施例中的人工心脏瓣膜支架的流入端的局部放大示意图；
图6为如图2所示的一个实施例中的人工心脏瓣膜支架的流出端的局部放大示意图；
图7为如图6所示的一个实施例中的人工心脏瓣膜支架的流出端的A区域的局部放大示意图；
图8为如图6所示的一个实施例中的人工心脏瓣膜支架的流出端的B区域的局部放大示意图；
图9为如图2所示的一个实施例中的人工心脏瓣膜支架的过渡段的局部放大示意图；
图10为如图2所示的一个实施例中的一种人工心脏瓣膜支架的压握状态结构示意图；
图11为如图2所示的一个实施例中的一种人工心脏瓣膜支架的流入端的陀螺形中空框架单元的示意图；
图12本申请的一个实施例中的一种四层人工心脏瓣膜支架的展开结构示意图；
图13本申请的一个实施例中的一种三层人工心脏瓣膜支架的展开结构示意图；
图14为如图1所示的一个实施例中的多个瓣叶的安装结构示意图；
图15为如图1所示的一个实施例中的瓣叶的结构示意图；
图16为如图1所示的一个实施例中的夹片的结构示意图；
图17为如图1所示的一个实施例中的夹片和瓣叶的相对位置示意图；
图18为如图1所示的一个实施例中的另一种瓣叶的结构示意图；
图19为如图1所示的一个实施例中的第一缝合膜的结构示意图；
图20为如图1所示的一个实施例中的外裙边的结构示意图；和
图21为如图1所示的一个实施例中的内裙边的结构示意图。
附图标号说明：
100：瓣叶；110：瓣膜体；121：瓣叶尾部；122：密封条；123：固定件；124：固定端；125：夹片；126：夹片缝合孔；131：瓣叶主体；132：密封条；134：固定端；200：人工心脏瓣膜支架；210：流入端；211：流入端框架单元；212：流入端连接区域；213：第一凸起部；214：第二凸起部；215：第一连接部；216：第二连接部；220：流出端；221：流出端框架单元；222：流出端连接区域；223：第三凸起部；224：第四凸起部；225：第三连接部；226：第四连接部；227：缝合部；228：缝合孔；230：过渡段；231：过渡段框架单元；232：过渡段连接区域；233：第五凸起部；234：第六凸起部；235：第五连接部；236：第六连接部；300：第一缝合膜；400：外裙边；500：内裙边；600：人工心脏瓣膜支架；610：流入端；620：流出端；630：过渡段；700：人工心脏瓣膜支架；710：流入端；720：流出端；730：过渡段。
具体实施方式
除非另作定义，在本说明书和权利要求书中使用的技术术语或者科学术语应当为本发明所属技术领域内具有一般技能的人士所理解的通常意义。
本文中列举的所有的从最低值到最高值之间的数值，是指当最低值和最高值之间相差两个单位以上时，最低值与最高值之间以一个单位为增量得到的所有数值。
在本发明的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”等的特征可以明示或 者隐含地包括一个或者更多个该特征。在本发明的描述中，除非另有说明，“多个”的含义是两个或两个以上。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，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，可以通过具体情况理解上述术语在本发明中的具体含义。
下面将参考附图并结合实施例来详细说明本发明。需要指出的是，在这些实施方式的具体描述过程中，为了进行简明扼要的描述，本说明书不可能对实际的实施方式的所有特征均作详尽的描述。
本申请的实施例涉及如图1所示的一种人工心脏瓣膜，人工心脏瓣膜包括多片瓣叶100和如图1至图11所示的人工心脏瓣膜支架200，瓣叶100与人工心脏瓣膜支架200相连。人工心脏瓣膜支架200为可径向收缩及扩张的环形支架，人工心脏瓣膜支架200包括流入端210和流出端220。
如图5所示的流入端210包括多个相互连接的流入端框架单元211和多个流入端连接区域212，多个相互连接的流入端框架单元211为陀螺形的中空框架单元，流入端连接区域212为相邻的两个流入端框架单元211相互连接的区域。流入端框架单元211包括第一凸起部213和第二凸起部214，第一凸起部213沿支架的轴向方向朝流出端220的方向凸出，第二凸起部214沿支架的轴向方向朝远离流出端220的方向凸出，第一凸起部213与相邻的两个流入端连接区域212的连线的垂直距离小于或等于第二凸起部214与相邻的两个流入端连接区域212的连线的垂直距离。
在一些实施例中，陀螺形的中空框架单元的环形内部轮廓如图11所示。参考图11，陀螺形的中空框架单元的环形内部轮廓可由光滑连接的第一直线AB、第一二次曲线BC、第二直线CD、第二二次曲线DE、第三直线EF、第三二次曲线FG、第四直线GH以及第四二次曲线HA组成。在一个实施例中，第一直线AB与第二直线CD长度相等，且第三直线EF与第四直线GH长度相等。第一直线AB或第二直线CD的长度大于或者等于第三直线EF和第三直线GH的长度。在一个实施例中，第一二次曲线BC为朝向流出端220的方向凸出的抛物线，并包括一个极大值P1。在一个实施例中，第三二次曲线FG为远离流出端220的方向凸出的抛物线，并包括一个极大值P3。在一个实施例中，第一二次曲线BC的抛物线开口小于或等于第三二次曲线FG的抛物线开口。在一个实施例中，第二二次曲线DE为远离流入端框架单元211纵向轴线沿周向向外凸出的弧线，并包括一个极大值P2。在一个实施例中，第四二次曲线HA为远离流入端框架单元211纵向轴线沿周向向外凸出的弧线，并包括一个极大值P4。在一个实施例中，第二二次曲线DE和第四二次曲线HA相互对称。在一个实施例中，极大值P2和P4在同一水平高度上，极大值P1至该水平高度的垂直距离大于或等于极大值P3至该水平高度的垂直距离。在一个实施例中，极大值P1至该水平高度的垂直距离可为极大值P3至该水平高度的垂直距离的1-2.5倍。换句话说，由P4-P1-P2形成的框架轮廓沿着流入端框架单元211纵向轴线延伸的长度大于或等于由P4-P3-P2形成的框架轮廓沿着流入端框架单元211纵向轴线延伸的长度。
如图6所示的流出端220包括多个相互连接的流出端框架单元221和多个流出端连接区域222，多个相互连接的流出端框架单元221为六边形的中空框架单元，流出端连接区域222为相邻的两个流出端框架单元221相互连接的区域。
在一些实施例中，流入端框架单元211还包括第一连接部215和第二连接部216，第一连接部215位于第一凸起部213和流入端连接区域212之间，第二连接部216位于第二凸起部214和流入端连接区域212之间。流入端连接区域212沿支架周向上的宽度大于第一连接部215和第二连接部216沿支架周向上的宽度的平均值的2倍。
在一些实施例中，流入端连接区域212沿支架轴向上的长度为第一连接部215和第二连接部216沿支架周向上的宽度的平均值的1倍至3倍。例如，可以是1倍、1.2倍、1.5倍、1.6倍、1.8倍、2倍、2.2倍、2.5倍、2.6倍、2.8倍或3倍。
在一些实施例中，相邻的两个流入端连接区域212之间的距离与流入端框架单元211的第一凸起部213和第二凸起部214之间的距离的比值为0.8～1，例如，可以为0.9。
在一些具体的实施例中，流入端210在流入端连接区域212之外的其余部分宽度相同。
在一些实施例中，第一凸起部213的顶部内侧、第二凸起部214的顶部内侧和/或第二凸起部214的顶部外侧为圆弧形或椭圆弧形。在一些具体的实施例中，第一凸起部213的顶部内侧、第二凸起部214的顶部内侧和/或第二凸起部214的顶部外侧可以为130°～150°的圆弧形，例如，可以是130°、140°或150°。通过第一凸起部213的圆弧形或椭圆弧形结构设计，可以避免人工心脏瓣膜支架200在压握过程中被过度压握而导致结构变形或无法正常扩张等不利情况的发生。此外，通过第二凸起部214的圆弧形或椭圆弧形结构设计，可以避免戳破外部球囊。
在一些实施例中，流出端连接区域222沿支架周向上的宽度小于流入端连接区域212沿支架周向上的宽度。优选的，流出端连接区域222沿支架周向上的宽度小于流入端连接区域212沿支架周向上的宽度的一半。在具体的实施例中，相邻的两个流出端框架单元221可以共用一条边作为流出端连接区域222。
在一些实施例中，流出端框架单元221包括第三凸起部223和第四凸起部224，第三凸起部223沿支架的轴向方向朝流出端220的方向凸出，第四凸起部224沿支架的轴向方向朝远离流出端220的方向凸出。流出端框架单元221还包括第三连接部225和第四连接部226，第三连接部225位于第三凸起部223和流出端连接区域222之间，第四连接部226位于第四凸起部224和流出端连接区域222之间。
在一些实施例中，第三凸起部223的顶部内侧、第三凸起部223的顶部外侧和/或第四凸起部224的顶部内侧为圆弧形或椭圆弧形。在一些具体的实施例中，第三凸起部223的顶部内侧、第三凸起部223的顶部外侧和/或第四凸起部224的顶部内侧可以为130°～150°的圆弧形，例如，可以是130°、140°或150°。第三凸起部223的局部放大图如图7所示，通过第三凸起部223的圆弧形或椭圆弧形结构设计，可以避免输送或扩张过程中第三凸起部223经压握后接触并夹住球囊，致使球囊在膨胀过程中因受力不均匀而破裂，也可以避免支架因过度压握而无法顺利扩张。
在一些实施例中，相邻的两个第三连接部225之间、相邻的两个第四连接部226之间、第三连接部225和相邻的流出端连接区域222之间和/或第四连接部226和相邻的流出端连接区域222之间圆弧连接。该圆弧的角度可以是130°～150°，例如，可以是130°、140°或150°。其中，相邻的两个第三连接部225之间和第三连接部225和相邻的流出端连接区域222之间的圆弧连接可以如图8所示。通过该圆弧设置，也可以避免支架因过度压握而无法顺利扩张。
在一些实施例中，流出端220在流出端连接区域222之外的其余部分宽度相同。通过该结构设计，可以使人工心脏瓣膜支架200在压握状态下呈现如图10所示的对称且均匀的压握状态，并可以避免由于宽度不同导致局部支撑力过大而产生的压握后的非正常状态，即压握不对称的情况。
在一些实施例中，至少一个流出端连接区域222上设有缝合部227，缝合部227为沿支架的轴向方向设置的中间宽两端窄的片状结构。在一些具体的实施例中，缝合部227上设有至少两个缝合孔228。
在一些实施例中，第三连接部225和相邻的缝合部227之间和/或第四连接部226和相邻的缝合部227之间圆弧连接。该圆弧的角度可以是130°～150°，例如，可以是130°、140°或150°。
在一些实施例中，支架进一步包括设置于流入端210和流出端220之间的如图9所示的过渡段230，过渡段230包括多个相互连接的过渡段框架单元231和多个过渡段连接区域232，多个相互连接的过渡段框架单元231为陀螺形的中空框架单元，过渡段连接区域232为相邻的两个过渡段框架单元231相互连接的区域。在一些具体的实施例中，支架可以进一步包括单排、双排或多排相互连接的过渡段框架单元231和过渡段连接区域232。
过渡段框架单元231包括第五凸起部233和第六凸起部234，第五凸起部233沿支架的轴向方向朝流出端220的方向凸出，第六凸起部234沿支架的轴向方向朝远离流出端220的方向凸出。
在一些具体的实施例中，第五凸起部233与相邻的两个过渡段连接区域232的连线的垂直距离等于第六凸起部234与相邻的两个过渡段连接区域232的连线的垂直距离。
在一些实施例中，相邻的两个过渡段连接区域232之间的距离与第五凸起部233和第六凸起部234之间的距离之间的比值大于1。优选的，相邻两个过渡段连接区域232之间的距离与第五凸起部233和第六凸起部234之间的距离之间的比值大于1.2。通过该结构设计，可以使过渡段框架单元231的纵向长而轴向短，进而可以防止支架因扩张困难，而出现两头粗中部细的骨头状结构，使支架扩张更为均匀，使用效果好。
在一些实施例中，过渡段框架单元231还包括第五连接部235和第六连接部236，第五连接部235位于第五凸起部233和过渡段连接区域232之间，第六连接部236位于第六凸起部234和过渡段连接区域232之间。在一些实施例中，当支架包括单排过渡段框架单元231和过渡段连接区域232时，第五连接部235与流出端220的第四连接部226重合，而第六连接部236与流入端210的第一连接部215重合。
过渡段连接区域232沿支架轴向上的长度与第五连接部235和第六连接部236沿支架周向上的宽度的平均值的比值为0.8～1.3。优选的，过渡段连接区域232沿支架轴向上 的长度与第五连接部235和第六连接部236沿支架周向上的宽度的平均值的比值为1～1.1。过渡段连接区域232太长容易导致过渡段230不易膨胀，而导致支架直径两端大过渡段小的情况，在人工瓣膜植入人体后易发生与瓣环卡合不紧的风险，容易产生脱落风险而导致瓣膜植入失败。因此，通过本申请涉及的过渡段连接区域232的特殊结构设计，可以使过渡段230扩张性能得到保证，提高手术安全性和可靠性。
本申请的实施例还涉及一种如图12所示的人工心脏瓣膜支架。人工心脏瓣膜支架600包括流入端610、流出端620以及包含双层的过渡段框架单元和过渡段连接区域的过渡段630。人工心脏瓣膜支架600的结构可以与图1至图11所述的人工心脏瓣膜支架200近似。
本申请的实施例还涉及一种如图13所示的人工心脏瓣膜支架。人工心脏瓣膜支架700包括流入端710、流出端720以及包含单层的过渡段框架单元和过渡段连接区域的过渡段730。人工心脏瓣膜支架700的结构可以与图1至图11所述的人工心脏瓣膜支架200近似。
在如图14所示的多个瓣叶100的安装结构中，多片如图15所示的瓣叶100依次连接形成外圆周为圆环结构的瓣膜体110，瓣膜体110与人工心脏瓣膜支架200的内侧壁固定连接，瓣膜体110的中部可单向开合。在一些实施例中，通过多个瓣叶100，例如三个瓣叶100，围成了圆环结构的瓣膜体110，具备类似“单向阀”功能。
如图15所示的瓣叶100均包括瓣叶尾部121、密封条122和固定件123。瓣叶尾部121的外侧为突出结构，突出结构的外侧边缘与人工心脏瓣膜支架200相连，具体的，突出结构的外侧边缘可以与人工心脏瓣膜支架200的内侧壁连接。密封条122为可弯折结构，密封条122的外侧连接瓣叶尾部121的内侧，密封条122的内侧所在的侧面与瓣叶尾部121所在的平面垂直，密封条122的另两个对侧面分别设置有固定端124，固定端124翻折并包裹有夹片125后形成固定件123，通过固定件123与人工心脏瓣膜支架200固定连接。如图15所示，为密封条122未弯折状态下的瓣叶100，在密封条122的左右两侧面向外延伸形成固定端124。如图16所示的夹片125的厚度优选0.1毫米-0.5毫米，夹片125上设置有至少一个夹片缝合孔126，经夹片缝合孔126将固定端124经缝合线缝合并包裹住夹片125。
在另一些实施例中，瓣叶还可以如图18所示，瓣叶包括瓣叶主体131、密封条132和固定件。瓣叶主体131的外侧边缘与人工心脏瓣膜支架200的内侧壁连接。密封条132为可弯折结构，密封条132的外侧连接瓣叶主体131的内侧，密封条132的内侧所在的侧面与瓣叶主体131所在的平面垂直。密封条132的另两个对侧面分别设置有固定端134，固定端134翻折并包裹有夹片后形成固定件，并通过固定件与人工心脏瓣膜支架200固定连接。
参照图17，相邻两个瓣叶100通过固定件123经夹片缝合孔126用缝合线缝合依次连接形成瓣膜体110，相邻两个瓣叶100中的密封条122内侧面端部接触以实现瓣膜体110的中部可单向开合。多个瓣叶100在通过固定件123与人工心脏瓣膜支架200固定连接时，也经夹片缝合孔126与人工心脏瓣膜支架200用缝合线缝合实现连接固定，固定时，将多个瓣叶100沿血液流动方向固定于人工心脏瓣膜支架200内。虽然原生瓣为二尖瓣，但考虑到结构的稳定性，本发明设计的二尖瓣瓣膜装置设计成多片瓣叶100，多片瓣叶100由夹片125固定形成固定件123，再进行缝合到人工心脏瓣膜支架200内的方式，增强了轴 向瓣叶100的强度和稳定性，将瓣叶100与人工心脏瓣膜支架200的点接触变成了线接触，减小血流通过时，局部瓣叶100，特别是远端瓣叶100的拉力，使结构更加稳固。纵向缝合的方式保证了其“单向阀”功能的同时有效提高了其对反向压力的承载能力。
在一些具体的实施例中，人工心脏瓣膜还包括如图19所示的第一缝合膜300，第一缝合膜300可以是高分子薄膜。第一缝合膜300可以与人工心脏瓣膜支架200的全部的流入端框架单元211缝合，并将流入端框架单元211的中空部分完全覆盖。第一缝合膜300还可以与至少部分的过渡段框架单元231缝合，并将该部分过渡段框架单元231的中空部分完全覆盖。第一缝合膜300可以防瓣周漏，又可以避免堵住冠状动脉。在人工心脏瓣膜支架包括四层结构的实施例中，第一缝合膜可覆盖第四层的所有流入端框架单元、第三层的所有过渡段框架单元以及部分的第二层的过渡段框架单元。例如，第一缝合膜可间隔地覆盖第二层的过渡段框架单元。在在人工心脏瓣膜支架包括三层结构的实施例中，第一缝合膜可覆盖第三层的所有流入端框架单元以及部分的第二层的过渡段框架单元。例如，第一缝合膜可间隔地覆盖第二层的过渡段框架单元。
在一些具体的实施例中，人工心脏瓣膜还包括如图20所示的外裙边400，外裙边400可以是高分子薄膜，并设置于人工心脏瓣膜支架200的外侧。外裙边400的一端包括锯齿状结构，锯齿状结构可以与人工心脏瓣膜支架200流入端210的形状相匹配，并与人工心脏瓣膜支架200缝合固定，具体的，该锯齿状结构可以与人工心脏瓣膜支架200的第二凸起部214和第二连接部216缝合固定。外裙边400可以用于防瓣周漏。
在一些具体的实施例中，人工心脏瓣膜还包括如图21所示的内裙边500。瓣叶尾部121外侧的突出结构为缝合固定在瓣叶尾部121外侧的内裙边500，内裙边500与瓣叶尾部121外侧边缘的形状相匹配。内裙边500可以是高分子薄膜，内裙边500可以用于防瓣周漏。
以上的具体实施例，对本发明的目的、技术方案和有益效果进行了进一步详细说明，所应理解的是，以上仅为本发明的具体实施例而已，并不用于限制本发明，凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (20)

  1. 一种人工心脏瓣膜，所述人工心脏瓣膜包括多片瓣叶和人工心脏瓣膜支架，所述瓣叶与所述人工心脏瓣膜支架相连；所述支架为可径向收缩及扩张的环形支架，所述支架包括流入端和流出端，其特征在于，
    所述流入端包括多个相互连接的流入端框架单元和多个流入端连接区域，所述多个相互连接的流入端框架单元为陀螺形的中空框架单元，所述流入端连接区域为相邻的两个所述流入端框架单元相互连接的区域；所述流入端框架单元包括第一凸起部和第二凸起部，所述第一凸起部沿所述支架的轴向方向朝所述流出端的方向凸出，所述第二凸起部沿所述支架的轴向方向朝远离所述流出端的方向凸出，所述第一凸起部与相邻的两个所述流入端连接区域的连线的垂直距离小于或等于所述第二凸起部与相邻的两个所述流入端连接区域的连线的垂直距离；
    所述流出端包括多个相互连接的流出端框架单元和多个流出端连接区域，所述多个相互连接的流出端框架单元为六边形的中空框架单元，所述流出端连接区域为相邻的两个所述流出端框架单元相互连接的区域。
  2. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述流入端框架单元还包括第一连接部和第二连接部，所述第一连接部位于所述第一凸起部和所述流入端连接区域之间，所述第二连接部位于所述第二凸起部和所述流入端连接区域之间；所述流入端连接区域沿所述支架周向上的宽度大于所述第一连接部和所述第二连接部沿所述支架周向上的宽度的平均值的2倍。
  3. 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述流入端连接区域沿所述支架轴向上的长度为所述第一连接部和所述第二连接部沿所述支架周向上的宽度的平均值的1倍至3倍。
  4. 根据权利要求1所述的人工心脏瓣膜，其特征在于，相邻的两个所述流入端连接区域之间的距离与所述流入端框架单元的所述第一凸起部和所述第二凸起部之间的距离的比值为0.8～1。
  5. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述第一凸起部的顶部内侧、所述第二凸起部的顶部内侧和/或所述第二凸起部的顶部外侧为圆弧形或椭圆弧形。
  6. 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述流出端连接区域沿所述支架周向上的宽度小于所述流入端连接区域沿所述支架周向上的宽度。
  7. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述流出端框架单元包括第三凸起部和第四凸起部，所述第三凸起部沿所述支架的轴向方向朝所述流出端的方向凸出，所述第四凸起部沿所述支架的轴向方向朝远离所述流出端的方向凸出；所述流出端框架单元还包括第三连接部和第四连接部，所述第三连接部位于所述第三凸起部和流出端连接区域之间，所述第四连接部位于所述第四凸起部和流出端连接区域之间。
  8. 根据权利要求7所述的人工心脏瓣膜，其特征在于，所述第三凸起部的顶部内侧、所述第三凸起部的顶部外侧和/或所述第四凸起部的顶部内侧为圆弧形或椭圆弧形。
  9. 根据权利要求7所述的人工心脏瓣膜，其特征在于，相邻的两个所述第三连接部之间、相邻的两个所述第四连接部之间、所述第三连接部和相邻的所述流出端连接区域之间和/或所述第四连接部和相邻的所述流出端连接区域之间圆弧连接。
  10. 根据权利要求7所述的人工心脏瓣膜，其特征在于，至少一个所述流出端连接区域上设有缝合部，所述缝合部为沿所述支架的轴向方向设置的中间宽两端窄的片状结构。
  11. 根据权利要求10所述的人工心脏瓣膜，其特征在于，所述第三连接部和相邻的所述缝合部之间和/或所述第四连接部和相邻的所述缝合部之间圆弧连接。
  12. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述支架进一步包括设置于所述流入端和所述流出端之间的过渡段，所述过渡段包括多个相互连接的过渡段框架单元和多个过渡段连接区域，所述多个相互连接的过渡段框架单元为陀螺形的中空框架单元，所述过渡段连接区域为相邻的两个所述过渡段框架单元相互连接的区域；所述过渡段框架单元包括第五凸起部和第六凸起部，所述第五凸起部沿所述支架的轴向方向朝所述流出端的方向凸出，所述第六凸起部沿所述支架的轴向方向朝远离所述流出端的方向凸出。
  13. 根据权利要求12所述的人工心脏瓣膜，其特征在于，所述第五凸起部与相邻的两个所述过渡段连接区域的连线的垂直距离等于所述第六凸起部与相邻的两个所述过渡段连接区域的连线的垂直距离。
  14. 根据权利要求12所述的人工心脏瓣膜，其特征在于，相邻的两个所述过渡段连接区域之间的距离与所述第五凸起部和所述第六凸起部之间的距离之间的比值大于1。
  15. 根据权利要求14所述的人工心脏瓣膜，其特征在于，所述过渡段框架单元还包括第五连接部和第六连接部，所述第五连接部位于所述第五凸起部和所述过渡段连接区域之间，所述第六连接部位于所述第六凸起部和所述过渡段连接区域之间；所述过渡段连接区域沿所述支架轴向上的长度与所述第五连接部和所述第六连接部沿所述支架周向上的宽度的平均值的比值为0.8～1.3。
  16. 根据权利要求15所述的人工心脏瓣膜，其特征在于，所述过渡段连接区域沿所述支架轴向上的长度与所述第五连接部和所述第六连接部沿所述支架周向上的宽度的平均值的比值为1～1.1。
  17. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述瓣叶包括：
    瓣叶尾部，所述瓣叶尾部的外侧为突出结构，所述突出结构的外侧边缘与所述人工心脏瓣膜支架相连；
    密封条，所述密封条为可弯折结构，所述密封条的外侧连接所述瓣叶尾部的内侧，内侧所在的侧面与所述瓣叶尾部所在的平面垂直，所述密封条的另两个对侧面分别设置有固定端，所述固定端翻折并包裹有夹片后形成固定件，通过所述固定件与所述人工心脏瓣膜支架固定连接；
    相邻两个所述瓣叶通过所述固定件依次连接形成瓣膜体，相邻两个所述瓣叶中的密封条内侧面端部接触以实现所述瓣膜体的中部可单向开合。
  18. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述人工心脏瓣膜进一步包括第一缝合膜，第一缝合膜与人工心脏瓣膜支架的全部流入端框架单元缝合，并将流入端框架单元的中空区域完全覆盖。
  19. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述人工心脏瓣膜进一步包括外裙边，所述外裙边的一端包括锯齿状结构，所述锯齿状结构与所述人工心脏瓣膜支架的流入端的形状相匹配，并与所述人工心脏瓣膜支架缝合固定。
  20. 根据权利要求17所述的人工心脏瓣膜，其特征在于，所述瓣叶尾部外侧的突出结构为缝合固定在瓣叶尾部外侧的内裙边，所述内裙边与所述瓣叶尾部外侧边缘的形状相匹配。
PCT/CN2022/089329 2021-09-28 2022-04-26 一种人工心脏瓣膜 WO2023050788A1 (zh)

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