WO2021004462A1 - 一种人工心脏瓣叶及心脏瓣膜假体 - Google Patents

一种人工心脏瓣叶及心脏瓣膜假体 Download PDF

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Publication number
WO2021004462A1
WO2021004462A1 PCT/CN2020/100712 CN2020100712W WO2021004462A1 WO 2021004462 A1 WO2021004462 A1 WO 2021004462A1 CN 2020100712 W CN2020100712 W CN 2020100712W WO 2021004462 A1 WO2021004462 A1 WO 2021004462A1
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WIPO (PCT)
Prior art keywords
heart valve
artificial heart
wall
valve leaflet
leaflet
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PCT/CN2020/100712
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English (en)
French (fr)
Inventor
金亮
刘世红
赵婧
陈国明
李�雨
Original Assignee
上海微创心通医疗科技有限公司
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Publication of WO2021004462A1 publication Critical patent/WO2021004462A1/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
    • 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

Definitions

  • the invention relates to the technical field of medical devices, in particular to an artificial heart valve leaflet and a heart valve prosthesis.
  • Heart valves include the aortic valve connecting the left ventricle and the aorta, the pulmonary valve connecting the right ventricle and the pulmonary artery, the mitral valve connecting the left atrium and the left ventricle, and the tricuspid valve connecting the right atrium and the right ventricle. All heart valves act as a one-way valve. With the rhythmic contraction and relaxation of the heart in the blood circulation, the heart valves also open and close rhythmically, allowing blood to pass through the valve orifices smoothly and prevent reflux. The blood circulates in a certain direction in the body.
  • heart valve disease When the heart valve is inflamed, it will cause structural damage, fibrosis, adhesion, shortening, myxoma-like lesions, avascular necrosis, calcium deposits and other problems, affecting normal blood circulation. This is called heart valve disease. .
  • the artificial heart valve leaflet is an artificial organ that can be implanted into the heart to replace the heart valve.
  • the heart valve disease is severe and cannot be restored or improved with valve separation or repair, artificial heart valve replacement must be used.
  • the existing artificial heart valve leaflet still has the problem of incomplete closure of the artificial heart valve leaflet due to insufficient closing height and insufficient leaflet joint area.
  • the transvalvular pressure difference is an important hemodynamic parameter for evaluating the function of the artificial heart valve leaflet.
  • the blocking effect of the artificial heart valve leaflet on blood flow will produce a transvalvular pressure difference.
  • the greater the transvalvular pressure difference the speed of blood flow
  • the greater the gradient the resulting shear stress also increases, and once the shear stress exceeds the threshold of damage to blood components, hemolysis or sub-hemolysis will occur, and even damage to vascular endothelial cells.
  • the purpose of the present invention is to provide an artificial heart valve leaflet and a heart valve prosthesis, which can be fully closed to avoid regurgitation, thereby avoiding a large transvalvular pressure difference.
  • an artificial heart valve leaflet which includes at least two leaflets distributed in a ring shape, and each leaflet includes a main body wall and a closed wall connected in the axial direction;
  • the artificial heart valve leaflet has a closed state and an open state
  • the at least two leaflets are configured to separate the closed walls of the at least two leaflets when the artificial heart valve leaflets are in the open state;
  • the at least two leaflets are also configured such that when the artificial heart valve leaflets are in the closed state, the main body walls of the adjacent leaflets at least partially overlap to close the artificial heart valve leaflets in the circumferential direction, and at the same time The closed walls of the adjacent leaflets at least partially overlap to close at least one end of the artificial heart valve leaflet in the axial direction.
  • the at least two leaflets are further configured such that when the artificial heart valve leaflet is in the open state, the main body walls of the adjacent leaflets at least partially overlap.
  • the artificial heart valve leaflet when the artificial heart valve leaflet is in the closed state, the artificial heart valve leaflet has a funnel-shaped structure and the closed walls of adjacent leaflets at least partially overlap to close the tip of the funnel-shaped structure Closed.
  • the at least two leaflets are configured to close the wall and separate under the action of an external force so that the artificial heart valve leaflet is in the open state, and the at least two leaflets can be automatically reset after the external force is released to make
  • the closing wall at least partially overlaps so that the artificial heart valve leaflet can be restored from the open state to the closed state.
  • the at least two leaflets are configured to close the wall and separate under the action of an external force so that the artificial heart valve leaflet is in the open state, and the at least two leaflets can automatically contract after the external force is released to make
  • the closing wall at least partially overlaps so that the artificial heart valve leaflet can be restored from the open state to the closed state.
  • the elastic modulus of each leaflet is greater than 0.2 GPa-2.5 GPa.
  • each of the leaflets is made of a shape memory material.
  • each of the main body walls includes a joint wall, a curved wall, and an extension wall that are sequentially connected in the axial direction;
  • the curved wall is arc-shaped in the axial section of the artificial heart valve leaflet;
  • the extension wall Connected with the closed wall;
  • the curved walls of the adjacent leaflets at least partially overlap, and the extension walls of the adjacent leaflets at least partially overlap.
  • the angle between the extension wall and the reference surface is ⁇
  • the angle between the closed wall and the reference surface is ⁇ , and ⁇ > ⁇ .
  • the angle between the tangent at the connection point of the joining wall and the curved wall and the reference plane is ⁇
  • the tangent at the connection point of the curved wall and the extension wall is the same as the reference plane
  • the angle between is ⁇ , and ⁇ > ⁇ > ⁇ , ⁇ .
  • a heart valve prosthesis provided by the present invention includes:
  • the stent has opposite inflow and outflow ends;
  • the aforementioned artificial heart valve leaflet is arranged in the stent, and the main body wall of the artificial heart valve leaflet is connected to the stent.
  • the main body wall includes a joining wall, a curved wall, and an extension wall that are sequentially connected in the axial direction, wherein the joining wall is connected to the inflow end of the bracket.
  • the stent has a position of the stent annulus corresponding to the annulus of the heart, and when the artificial heart valve leaflet is in the closed state, the main body wall is close to the closed wall of the artificial heart valve leaflet.
  • the connection position corresponds to the position of the stent annulus.
  • the heart valve prosthesis further includes a skirt, the skirt includes an inner skirt and an outer skirt that are connected; the inner skirt is arranged on the inner side of the inflow end of the stent; the outer skirt The edge is arranged on the outer side surface of the inflow end of the bracket, and the edge of the outer skirt away from the inner skirt is wavy.
  • the artificial heart valve leaflet and heart valve prosthesis of the present invention have the following advantages:
  • the artificial heart valve leaflet of the present invention includes at least two leaflets, and each leaflet has a main body wall and a closing wall arranged in sequence from the inflow end to the outflow end of the heart valve prosthesis, wherein when the artificial heart valve leaflet is in a closed state At this time, the main body walls of adjacent leaflets at least partially overlap, and the closed walls of adjacent leaflets also overlap at least partially to seal the artificial heart valve leaflets.
  • the leaflets of the present invention can preferably be automatically reset after the external force is released, so that the artificial heart valve leaflets can be automatically closed, which can avoid the problem of incomplete closure due to the deviation of the implanted position.
  • the leaflets are preferably made of a material with an elastic modulus greater than 0.2 GPa, or a shape memory material, so that the artificial heart valve leaflet can automatically return to the closed state after opening with the contraction of the heart.
  • connection position of the main body wall and the closing wall is equivalent to the position of the stent ring of the stent, which helps to increase the closing height of the artificial heart valve leaflet, thereby improving the closure of the artificial heart valve leaflet.
  • Figure 1a is a top view of an artificial heart valve leaflet according to an embodiment of the present invention, in which the artificial heart valve leaflet is in a closed state;
  • Fig. 1b is a top view of the artificial heart valve leaflet shown in Fig. 1a in an open state;
  • FIG. 2 is a schematic diagram of the structure of the leaflets of the artificial heart valve leaflet according to an embodiment of the present invention
  • Fig. 3 is a schematic diagram of the structure of the artificial heart valve leaflet formed by superimposing the leaflets shown in Fig. 1a;
  • FIGS. 4a and 4b are respectively structural schematic diagrams of leaflets provided according to an embodiment of the present invention.
  • Fig. 5 is a schematic diagram of the slope relationship of the leaflets according to an embodiment of the present invention.
  • Fig. 6a is a schematic structural diagram of a heart valve prosthesis according to an embodiment of the present invention, in which the artificial heart valve leaflets are in a closed state;
  • Fig. 6b is a schematic structural diagram of a heart valve prosthesis according to an embodiment of the present invention, in which the artificial heart valve leaflet is in an open state;
  • Fig. 7 is a schematic structural diagram of a skirt of a heart valve prosthesis according to an embodiment of the present invention.
  • valve leaflets mentioned in the following description unless specified as native valve leaflets, all refer to artificial heart valve leaflets.
  • an artificial heart valve leaflet 1000 provided by an embodiment of the present invention has an open state and a closed state, wherein Figure 1a shows the artificial heart valve leaflet 1000 The schematic diagram in the closed state, FIG. 1b shows the schematic diagram when the artificial heart valve leaflet 1000 is in the open state.
  • the artificial heart valve leaflet 1000 includes at least two leaflets 1100 arranged in a ring shape, and each leaflet 1100 includes a main body wall 1110 and a closing wall 1120 that are sequentially connected in the axial direction.
  • the main body wall 1110 and the closing wall 1120 are arranged in sequence, that is, the "axial direction" refers to the direction parallel to the blood flow after the artificial heart valve leaflet 1000 is implanted in the heart .
  • the ring shape can be a regular shape such as a circle, a rectangle, a regular polygon, etc., or other irregular shapes.
  • a circle is taken as an example for description in this embodiment, so that it is perpendicular to the blood flow direction.
  • the direction of is the radial direction of the artificial heart valve leaflet 1000.
  • the closed walls 1120 of the leaflet 1100 are separated from each other without overlapping.
  • the closed walls 1120 of the leaflets 1100 are close to each other so that the main body wall 1110 of the leaflets at least partially overlap to seal the artificial heart valve leaflet 1000 in the circumferential direction.
  • the closed walls 1120 of adjacent leaflets 1100 at least partially overlap to seal the artificial heart valve leaflet 1000 in the axial direction.
  • the artificial heart valve leaflet 1000 is closed at the end where the closed wall 1120 is located.
  • the "overlapping" herein refers to a state where any adjacent leaflets 1100 are superimposed and attached to each other.
  • the main body walls 1110 of any adjacent leaflets 1100 partially overlap, so that when the artificial heart valve leaflet 1000 is in the closed state, it can be ensured that its circumferential direction is reliable. Closed.
  • the artificial heart valve leaflet 1000 when the artificial heart valve leaflet 1000 is in the closed state, the artificial heart valve leaflet 1000 forms a funnel-shaped structure. At this time, the closed walls 1120 of any two adjacent leaflets 1000 at least partially overlap to seal the The tip of the funnel-shaped structure.
  • FIG. 3 shows the positional relationship of part of the leaflets 1100 when the artificial heart valve leaflet 1000 is in the open state. More specifically with reference to FIG. 3, four leaflets 1100 are arranged around a central axis and stacked in a circumferential direction. For example, from the direction of the closed wall 1120 to the main body wall 1110, the four leaflets 1100 are arranged in a counterclockwise order. They are marked as the first leaflet 1100a, the second leaflet 1100b, the third leaflet 1100c, and the fourth leaflet 1100d.
  • the second leaflet 1100b is located outside the first leaflet 1100a, and a part of the second leaflet 1100b always overlaps the first leaflet 1100a; the third leaflet 1100b
  • the leaflet 1100c is located outside the second leaflet 1100b, and a part of the third leaflet 1100c always overlaps the second leaflet 1100b;
  • the fourth leaflet 1100d is located outside the third leaflet 1100c, and the fourth leaflet 1100d
  • a part of the third leaflet 1100c always overlaps with the third leaflet 1100c, and so on, until the end of the main body wall 1110 of all leaflets 1100 away from the closed wall 1120 forms a ring shape to form a complete artificial heart valve leaflet 1000.
  • the closed walls 1120 of the leaflets 1100 approach each other and the closed walls 1120 of the adjacent leaflets 1100 partially overlap until the artificial heart valve leaflet 1000 forms a peripheral surface and a tip.
  • the overlapping area of the main body wall 1110 of the adjacent leaflets 1100 at this time is larger than the overlapping area of the main body wall 1110 of the adjacent leaflets 1100 in the open state.
  • the main body walls 1110 of adjacent leaflets 1100 are still partially overlapped, so as to ensure that the artificial heart valve leaflets 1000 are adjacent to each other in the closed state.
  • the main body wall 1110 has a sufficient joint area to ensure the closure effect of the artificial heart valve leaflet 1000 in the circumferential direction; on the other hand, when the artificial heart valve leaflet 1000 is in the closed state, because the main body wall 1110 has a certain thickness, the main body There is a small hole at the tip of the funnel-shaped structure formed by the wall 1110, and by providing a closed wall 1120 on the leaflet 1100, the adjacent closed walls 1120 can block the small holes when overlapping sequentially, and the closed wall 1120 can also increase
  • the closed height of the artificial heart valve leaflet 1000 further improves the closure of the artificial heart valve leaflet 1000 in the axial direction, so that the artificial heart valve leaflet 1000 can be completely closed at the end of the closed wall 1120, effectively preventing blood reflux and avoiding Large transvalve pressure difference. It should be understood that the “height” mentioned herein refers to the length of the artificial heart valve leaflet 1000 in the axial direction.
  • the leaflet 1100 forms an arc-shaped structure in the circumferential direction, and when the leaflet 1100 is stacked and contracted to the closed state, the overlapping portion of the main body wall 1110 can be better fitted to improve the closing effect.
  • the artificial heart valve leaflet 1000 is implanted into the heart through the stent 2000.
  • the stent 2000 has an inflow end 2100 and a flow out end 2200, wherein the inflow end 2100 refers to the inlet end of blood, and the outflow end 2200 refers to the outlet end of blood.
  • the artificial heart valve leaflet 1000 is arranged on the inner surface of the stent 2000, and the end of the main body wall 1110 of each leaflet 1100 away from the closing wall 1120 is connected to the inflow end 2100 of the stent 2000.
  • the bracket 2000 used in the embodiment of the present invention may be any existing bracket.
  • the closed height of the artificial heart valve leaflet 1000 is at least 3 mm.
  • the closed wall 1120 and the The height of the connection position of the main body wall 1110 should be equivalent to the height of the stent annulus.
  • the connection part of the closed wall 1120 and the main body wall 1110 is the same or approximately the same as the position of the stent valve ring in the axial direction of the artificial heart valve leaflet 1000. the same.
  • the height of the closed wall 1120 should also be greater than 1 mm, that is, when the artificial heart valve leaflet 1000 is in the closed state, the length of the closed wall 1120 along the axial direction of the artificial heart valve leaflet 1000 is greater than 1 mm.
  • the present invention does not make a strict limitation on the shape of the closed wall 1120, and its planar expanded shape can be a triangle, a rectangle, or other shapes.
  • the stent annulus is the position of the stent 2000 corresponding to the annulus in the heart, which is common knowledge in the art.
  • the main body wall 1110 is provided in three parts.
  • the main body wall 1110 includes a joining wall 1111, a curved wall 1112 and an extension wall 1113 connected in sequence.
  • the joint wall 1111 is used to connect with the inflow end 2100 of the stent 2000
  • the curved wall 1112 is made of elastic material
  • the axial section of the artificial heart valve leaflet 1000 is arc-shaped, so The extension wall 1122 is connected to the closing wall 1120.
  • the leaflet 1110 has a strong anti-bending ability when expanding outward, which can effectively improve the durability of the leaflet 1110, thereby increasing the service life of the artificial heart valve leaflet 1000.
  • the curved walls 1112 of adjacent leaflets 1100 at least partially overlap, and the adjacent leaflets 1100
  • the extension wall 1113 should also at least partially overlap.
  • the circumferential dimensions of the joint wall 1111 of the leaflet and the curved wall 1112 are equivalent, and the planar expanded shape of both can be rectangular.
  • the planar expansion shape of the extension wall 1113 may be a trapezoid.
  • the leaflet 1100 shown in FIG. 2 is only one specific shape, and it is not the only choice.
  • FIGS. 4a and 4b show the other two leaflet 1100 shapes, among which the leaflet 1100 shown in FIG. 4a ,
  • the planar expansion shape of the extension wall 1113 is a triangle, and in the leaflet 1100 shown in FIG.
  • the planar expansion shape of the extension wall 1113 is a triangle, and the circumferential dimension of the joint wall 1111 is smaller than the curved The circumferential dimension of the wall 1112.
  • the extension wall 1113 is a straight structure. In fact, the extension wall 1113 may also be an arc structure.
  • the embodiment of the present invention does not particularly emphasize the shape of the leaflet 1100, as long as it can satisfy that when the artificial heart valve leaflet 1000 is in the open state, the curved walls 1112 of adjacent leaflets 1100 are at least partially overlapped, and at the same time, adjacent The extension wall 1113 of the leaflet 1100 also at least partially overlaps (that is, the main body wall 1110 of the adjacent leaflet 1100 partially overlaps).
  • each part of the leaflet 1100 can also be optimized.
  • the slope mentioned here refers to the angle between each part of the leaflet 1100 and the reference surface using the end surface of the joining wall 1111 away from the curved wall 1112 as the reference surface. In detail, as shown in FIG.
  • the angle between the extension wall 1113 and the reference plane is ⁇
  • the angle between the closed wall 1120 and the reference plane is ⁇ , and ⁇ > ⁇ ; more preferably In the axial direction, the angle between the tangent at the connecting point of the joining wall 1111 and the curved wall 1112 and the reference plane is ⁇ , and in the axial direction, the angle between the curved wall 1112 and the extension wall 1113
  • the angle between the tangent at the connection point and the reference plane is ⁇ , and ⁇ > ⁇ > ⁇ , ⁇ , and 30° ⁇ 90°, 30° ⁇ 90°, 30° ⁇ 90°, 60° ⁇ 90°.
  • the existing various artificial heart valve leaflets are similar to natural heart valves (ie aortic valve, pulmonary valve, mitral valve and tricuspid valve), and need to be connected to the papillary muscles to make the artificial heart after implantation in the heart
  • the contraction and expansion of the valve leaflets are controlled by the heart.
  • the artificial heart valve leaflet expands with the contraction of the heart and closes with the diastole of the heart, that is, the opening and closing of the existing artificial heart valve leaflet can only be passively performed under a force.
  • the implantation position of the artificial heart valve leaflet often fails to close well with the diastole of the heart due to the deviation of the implantation position of the artificial heart valve leaflet, resulting in mild reflux or local reflux, and triggering the artificial heart valve The problem of incomplete leaf closure.
  • the leaflet 1100 is configured to automatically reset after the external force is released, so that the artificial heart valve leaflet 1000 can return to the Closed state.
  • the leaflet 1100 may be made of a material with an elastic modulus between 0.2 GPa and 2.5 GPa, such as polyurethane (PU), polyethylene (PE), etc.; or, the leaflet 1100 may also be made of a shape memory material Into nickel-titanium alloys.
  • the artificial heart valve leaflet 1000 is in the closed state when no external force is applied, and the artificial heart valve leaflet 1000 does not need to be connected to the papillary muscle after implanting the artificial heart valve leaflet 1000 into the heart.
  • the artificial heart valve leaflet 1000 expands.
  • the artificial heart valve leaflet 1000 can automatically retract to the closed state.
  • an embodiment of the present invention also provides a heart valve prosthesis, including: a stent 2000 having opposite inflow and outflow ends 2100 and 2200; and the aforementioned artificial heart valve leaflet 1000, which is set on the stent
  • the inner surface of 2000, and the main body wall 1110 is connected to the inflow end 2100. More specifically, the joining wall 1111 of the main body wall 1110 is connected to the inflow end 2100.
  • the stent 2000 can adopt any existing stent.
  • the stent 2000 is grid-shaped and its cross-sectional shape is compatible with the artificial heart valve leaflet 1000.
  • the cross-section of the stent 2000 is Round.
  • the material of the stent 2000 may be a plastic expansion material with biocompatibility known in the art, such as medical stainless steel or a cobalt-chromium alloy, or a self-expandable material such as Nitinol.
  • the stent 2000 can be made by cutting a pipe or braided by metal wires.
  • the main body wall 1110 of the artificial heart valve leaflet 1000 is fixed to the inflow end 2100 of the stent 2000 by suture or other means, so that the artificial heart valve leaflet 1000 can be implanted into the heart through the stent 2000.
  • the heart valve prosthesis may further include a skirt 3000 connected to the inflow end 2100 of the stent 2000.
  • a skirt 3000 needs to be provided at the inflow end 2100 of the stent 2000 to prevent paravalvular leakage.
  • the skirt 3000 may include an inner skirt 3100 and an outer skirt 3200 connected to each other, wherein the inner skirt 3100 is arranged on the inner side of the bracket 2000, and the outer skirt 3200 is arranged on the inner side of the bracket 2000.
  • the inner skirt 3100 and the outer skirt 3200 may be an integral structure.
  • the edge of the outer skirt 3200 away from the inner skirt 3100 is wavy to reduce the amount of material.
  • the material of the skirt 3000 can be a conventional medical polymer material in the field, such as polyethylene terephthalate (PET), and the skirt 3000 can be fixed to it by stitching, thermal laminating, gluing, etc.
  • PET polyethylene terephthalate
  • the detailed working mode of the heart valve prosthesis is introduced by taking the implantation of the heart valve prosthesis into the heart instead of the tricuspid valve to control the blood flow between the right atrium and the right ventricle as an example.
  • the artificial heart valve leaflet 1000 When the heart relaxes and blood is pumped from the right ventricle to the lungs, the artificial heart valve leaflet 1000 is in the closed state to avoid blood reflux to the right atrium. During this period, more blood enters the right atrium. Subsequently, the heart contracts, blood flows in the right atrium, and the artificial heart valve leaflet 1000 expands radially outward to the open state under the action of blood flow force, and blood flows into the right ventricle. After the heart relaxes, the artificial heart valve leaflet 1000 automatically returns to the closed state due to the structure and material of the leaflet 1100 itself.
  • the leaflet 1100 is provided with a closed wall 1120, and the leaflets 1100 are arranged in a layered manner to form the artificial heart valve leaflet 1000, which ensures the artificial heart valve leaflet 1000.
  • the heart valve leaflet 1000 has good closing properties, can effectively prevent regurgitation, reduce the possibility of forming a large transvalvular pressure difference, and improve the working effect of the artificial heart valve leaflet 1000.
  • the leaflet 1100 is prepared by using an elastic material with an elastic modulus greater than 0.2 GPa or a shape memory material, so that the artificial heart valve leaflet 1000 can be automatically reset to the closed state, thereby avoiding reflux caused by deviation of the implant position problem.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

本发明涉及一种人工心脏瓣叶及心脏瓣膜假体，包括分布成环形的至少两个小叶，且每个所述小叶包括在轴向上连接的主体壁和闭合壁；其中，所述人工心脏瓣叶具有闭合状态和打开状态；所述至少两个小叶被配置为当所述人工心脏瓣叶位于所述打开状态时，所述至少两个小叶的闭合壁分离；所述至少两个小叶还被配置为当所述人工心脏瓣叶位于所述闭合状态时，相邻的所述小叶的主体壁至少部分重叠以使所述人工心脏瓣叶的周向封闭，同时相邻的所述小叶的闭合壁至少部分重叠以使所述人工心脏瓣叶的轴向封闭。本发明的优点在于，本发明的人工心脏瓣叶可完全闭合以降低较大的跨瓣压差的产生。

Description

一种人工心脏瓣叶及心脏瓣膜假体 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叶及心脏瓣膜假体。
背景技术
心脏瓣膜包括连结左心室和主动脉的主动脉瓣、连结右心室和肺动脉的肺动脉瓣、连结左心房和左心室的二尖瓣以及连结右心房和右心室的三尖瓣。所有的心脏瓣膜均起到单向阀门的作用，在血液循环中随着心脏节律性的收缩和舒张，心脏瓣膜亦节律性的开放和关闭，使血液顺利通过瓣口并阻止返流，从而使血液在体内按一定的方向循环流动。当心脏瓣膜发生炎症时，会引起结构的损坏、纤维化、粘连、缩短、粘液瘤样性病变、缺血性坏死、钙质沉淀等问题，影响正常的血液循环，此称之为心脏瓣膜病。
人工心脏瓣叶是可植入心脏内以代替心脏瓣膜工作的人工器官。当心脏瓣膜病变严重且不能采用瓣膜分离术或修补术恢复、改善瓣膜功能时，必须采用人工心脏瓣叶置换术。然而现有的人工心脏瓣叶仍存在因闭合高度不够、小叶接合面积不足而导致的人工心脏瓣叶关闭不全的问题。当人工心脏瓣叶闭合不全时会造成部分血液返流并引起较大的跨瓣压差，跨瓣压差是评价人工心脏瓣叶功能的重要血流动力学参数。具体而言，人体内植入人工心脏瓣叶后，血液流经瓣口时，人工心脏瓣叶对血流的阻滞作用会产生跨瓣压差，跨瓣压差越大，血流的速度梯度就越大，由此产生的剪应力亦随之增大，而剪应力一旦超过对血液成分引起破坏的阈值就会引起溶血或亚溶血，甚至引起血管内皮细胞的损伤。
发明内容
本发明的目的在于提供一种人工心脏瓣叶及心脏瓣膜假体，能够充分闭合以避免出现返流，进而避免产生较大的跨瓣压差。
为实现上述目的，本发明提供的一种人工心脏瓣叶，包括分布成环形的 至少两个小叶，且每个所述小叶包括在轴向上连接的主体壁和闭合壁；其中：
所述人工心脏瓣叶具有闭合状态和打开状态；
所述至少两个小叶被配置为当所述人工心脏瓣叶位于所述打开状态时，所述至少两个小叶的闭合壁分离；
所述至少两个小叶还被配置为当所述人工心脏瓣叶位于所述闭合状态时，相邻的所述小叶的主体壁至少部分重叠以使所述人工心脏瓣叶的周向封闭，同时相邻的所述小叶的闭合壁至少部分重叠以使所述人工心脏瓣叶的轴向的至少一端封闭。
可选地，所述至少两个小叶还被配置为当所述人工心脏瓣叶位于所述打开状态时，相邻的所述小叶的主体壁至少部分重叠。
可选地，当所述人工心脏瓣叶位于所述闭合状态时，所述人工心脏瓣叶呈漏斗状结构且相邻的所述小叶的闭合壁至少部分重叠以封闭所述漏斗状结构的尖端封闭。
可选地，所述至少两个小叶被配置为在外力作用下闭合壁分离而使所述人工心脏瓣叶位于所述打开状态，并且所述至少两个小叶在外力解除后能够自动复位而使闭合壁至少部分重叠，以使所述人工心脏瓣叶能够从所述打开状态恢复至所述闭合状态。
可选地，所述至少两个小叶被配置为在外力作用下闭合壁分离而使所述人工心脏瓣叶位于所述打开状态，并且所述至少两个小叶在外力解除后能够自动收缩而使闭合壁至少部分重叠，以使所述人工心脏瓣叶能够从所述打开状态恢复至所述闭合状态。
可选地，每个所述小叶的弹性模量大于0.2GPa-2.5GPa。
可选地，每个所述小叶由形状记忆材料制成。
可选地，每个所述主体壁包括在轴向上依次连接的接合壁、弯曲壁和延伸壁；所述弯曲壁在所述人工心脏瓣叶的轴向截面呈弧形；所述延伸壁与所述闭合壁连接；
当所述人工心脏瓣叶位于所述打开状态时，相邻的所述小叶的弯曲壁至少部分重叠，相邻的所述小叶的延伸壁至少部分重叠。
可选地，以所述接合壁远离所述弯曲壁的端面为基准面，所述延伸壁与所述基准面间的夹角为β，所述闭合壁与所述基准面间的夹角为α，且α>β。
可选地，所述接合壁与所述弯曲壁连接点处的切线与所述基准面间的夹角为θ，所述弯曲壁与所述延伸壁的连接点处的切线与所述基准面间的夹角为γ，且α>γ>β，γ<θ。
可选地，30°≤α≤90°，30°≤β≤90°，30°≤γ≤90°，60°≤θ≤90°。
此外，为实现上述目的，本发明提供的一种心脏瓣膜假体，包括：
支架，具有相对的流入端和流出端；以及
如前所述的一种人工心脏瓣叶，设置于所述支架内，且所述人工心脏瓣叶的主体壁与所述支架连接。
可选地，所述主体壁包括在轴向上依次连接的接合壁、弯曲壁和延伸壁，其中所述接合壁与所述支架的流入端连接。
可选地，所述支架具有与心脏的瓣环相对应的支架瓣环位置，当所述人工心脏瓣叶位于所述闭合状态时，所述主体壁与所述人工心脏瓣叶的闭合壁的连接位置与所述支架瓣环位置相对应。
可选地，所述心脏瓣膜假体还包括裙边，所述裙边包括相连的内裙边和外裙边；所述内裙边设置于所述支架的流入端的内侧面；所述外裙边设置于所述支架的流入端的外侧面，且所述外裙边远离所述内裙边的边缘呈波浪形。
与现有技术相比，本发明的人工心脏瓣叶和心脏瓣膜假体具有如下优点：
第一、本发明的人工心脏瓣叶包括至少两个小叶，且每一小叶具有从心脏瓣膜假体的流入端到流出端依次布置的主体壁和闭合壁，其中当人工心脏瓣叶位于闭合状态时，相邻的小叶的主体壁至少部分重合，且相邻的小叶的闭合壁亦至少部分重叠使得人工心脏瓣叶封闭。
第二、当心脏瓣膜位于打开状态时，相邻的小叶的主体壁仍有部分重合，这样做确保了心脏瓣膜在闭合状态时的完全闭合。
第三、本发明的小叶优选在解除外力后能够自动复位，使得人工心脏瓣叶能够自动闭合，这样做可避免因植入位置偏移而出现闭合不全的问题。为 此，所述小叶优选由弹性模量大于0.2GPa的材料制成，或由形状记忆材料制成，以使人工心脏瓣叶随心脏收缩而打开后能够自动恢复至闭合状态。
第四、所述主体壁与所述闭合壁的连接位置与所述支架的支架瓣环位置相当，有助于提高人工心脏瓣叶的闭合高度，进而改善人工心脏瓣叶的闭合性。
附图说明
图1a是本发明根据一实施例提供的人工心脏瓣叶的俯视图，图示中人工心脏瓣叶位于闭合状态；
图1b是图1a所示人工心脏瓣叶位于打开状态时的俯视图；
图2是本发明根据一实施例提供的人工心脏瓣叶的小叶的结构示意图；
图3是图1a所示小叶叠置构成人工心脏瓣叶的结构示意图；
图4a和图4b分别是本发明根据一实施例提供的小叶的结构示意图；
图5是本发明根据一实施例提供的小叶的坡度关系示意图；
图6a是本发明根据一实施例提供的心脏瓣膜假体的结构示意图，图中人工心脏瓣叶位于闭合状态；
图6b是本发明根据一实施例提供的心脏瓣膜假体的结构示意图，图中人工心脏瓣叶位于打开状态；
图7是本发明根据一实施例提供的心脏瓣膜假体的裙边的结构示意图。
图中：
1000-人工心脏瓣叶；
1100-小叶；1100a-第一小叶，1100b-第二小叶，1100c-第三小叶，1100d-第四小叶；
1110-主体壁；
1111-接合壁，1112-弯曲壁，1113-延伸壁；
1120-闭合壁；
2000-支架；
2100-流入端，2200-流出端；
3000-裙边；
3100-内裙边，3200-外裙边。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明提出的人工心脏瓣叶及心脏瓣膜假体的实施例作进一步详细说明。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。
如在本说明书和所附权利要求中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个或两个以上的对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“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或两个元件的相互作用关系。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。附图中相同或相似的附图标记代表相同或相似的部件。
以下描述中提到的瓣叶，除非说明是原生瓣叶，一律指的是人工心脏瓣叶。
请参阅图1a和图1b，并结合图2和图3，本发明实施例提供的一种人工心脏瓣叶1000具有一打开状态和一闭合状态，其中图1a所示的是人工心脏瓣叶1000位于所述闭合状态时的示意图，图1b所示的是人工心脏瓣叶1000位于所述打开状态时的示意图。
具体的，所述人工心脏瓣叶1000包括至少两个排布呈环形的小叶1100，每个所述小叶1100包括在轴向上依次连接的主体壁1110和闭合壁1120，这里，从人工心脏瓣叶假体的流入端到流出端，依次布置所述主体壁1110和闭合壁1120，也即，所述“轴向”是指将人工心脏瓣叶1000植入心脏后与血液 流向相平行的方向。所述环形可为圆形、矩形、正多边形等规则形状，也可为其他的不规则形状，为便于理解，本实施例中以圆形为例进行说明，如此，与所述血液流向相垂直的方向为人工心脏瓣叶1000的径向。以下描述中，假定小叶1100为超过两个且至少两个小叶1100布置呈圆形来说明本实施例的人工心脏瓣叶，但不应以此作为对本发明的限定。
当所述人工心脏瓣叶1000位于所述打开状态时，小叶1100的闭合壁1120相互分离而不重叠。而当所述人工心脏瓣叶1000位于所述闭合状态时，小叶1100的闭合壁1120相互靠近以使小叶的主体壁1110至少部分重叠进而使得所述人工心脏瓣叶1000的周向封闭，同时任意相邻小叶1100的闭合壁1120至少部分重叠以使所述人工心脏瓣叶1000的轴向封闭，在此，主要指所述人工心脏瓣叶1000在所述闭合壁1120所在的一端封闭。可理解，这里的“重叠”指的是在任意相邻小叶1100相互叠置并贴合的状态。
进一步地，当所述人工心脏瓣叶1000位于所述打开状态时，任意相邻小叶1100的主体壁1110部分重合，从而当人工心脏瓣叶1000位于所述闭合状态时可确保其周向可靠地封闭。较佳地，当所述人工心脏瓣叶1000位于所述闭合状态时，所述人工心脏瓣叶1000形成漏斗状结构，此时任意相邻两个小叶1000的闭合壁1120至少部分重叠以封闭所述漏斗状结构的尖端。
图3示出了人工心脏瓣叶1000位于所述打开状态时，部分小叶1100的位置关系。结合图3更具体来说，四片小叶1100围绕一中心轴线布置并且周向层叠设置，例如从所述闭合壁1120向所述主体壁1110的方向看，按逆时针的顺序将四片小叶1100分别记为第一小叶1100a、第二小叶1100b、第三小叶1100c和第四小叶1100d。在人工心脏瓣叶1000打开或闭合的过程中，所述第二小叶1100b处于所述第一小叶1100a的外侧，且第二小叶1100b始终有一部分与所述第一小叶1100a重叠；所述第三小叶1100c处于所述第二小叶1100b的外侧，且第三小叶1100c始终有一部分与所述第二小叶1100b重叠；所述第四小叶1100d处于所述第三小叶1100c的外侧，且第四小叶1100d始终有一部分与所述第三小叶1100c重叠，以此类推，直至所有的小叶1100的主体壁1110远离所述闭合壁1120的端部形成环形而构成一完整的人工心脏瓣叶1000。当 所述人工心脏瓣叶1000收缩至所述闭合状态时，小叶1100的闭合壁1120相互靠近并且相邻小叶1100的闭合壁1120部分重叠，直至所述人工心脏瓣叶1000形成一周面和尖端均封闭的漏斗状结构，此时相邻小叶1100的主体壁1110的重叠面积较打开状态时相邻小叶1100的主体壁1110的重叠面积大。
本发明实施例中，一方面在人工心脏瓣叶1000位于所述打开状态时，使相邻小叶1100的主体壁1110间仍有部分重叠，以确保人工心脏瓣叶1000在闭合状态时相邻的主体壁1110具有足够的接合面积以保证人工心脏瓣叶1000周向上的闭合效果；另一方面，所述人工心脏瓣叶1000位于所述闭合状态时，因所述主体壁1110存在一定厚度，主体壁1110形成的漏斗状结构的尖端存在一小孔，而通过在小叶1100上设置闭合壁1120，相邻的闭合壁1120在依次重叠时可以封堵所述小孔，并且闭合壁1120还能够增加人工心脏瓣叶1000的闭合高度，进一步改善人工心脏瓣叶1000在轴向上的闭合性，使得人工心脏瓣叶1000在闭合壁1120所在的一端能够完全封闭，有效防止血液返流，避免产生较大的跨瓣压差。应理解的是，本文所述及的“高度”指的是在人工心脏瓣叶1000的轴向上的长度。
作为优选，所述小叶1100在周向上形成弧形结构，并且小叶1100在叠置并收缩至所述闭合状态时，主体壁1110的重叠部分可以更好地贴合，以改善闭合效果。
如图6a所示，实际应用时，所述人工心脏瓣叶1000通过支架2000植入心脏。所述支架2000具有一流入端2100和一流出端2200，其中所述流入端2100是指血液的入口端，所述流出端2200是指血液的出口端。所述人工心脏瓣叶1000被设置于所述支架2000的内侧面，且各小叶1100的主体壁1110远离所述闭合壁1120的一端与所述支架2000的流入端2100连接。本发明实施例所使用的支架2000可以为现有的任一种支架。
一般而言，所述人工心脏瓣叶1000的闭合高度至少为3mm，为确保人工心脏瓣叶1000的闭合高度，当人工心脏瓣叶1000位于所述闭合状态时，所述闭合壁1120与所述主体壁1110的连接位置的高度应当与支架瓣环的高度相当。换言之，当人工心脏瓣叶1000位于所述闭合状态时，所述闭合壁1120 与所述主体壁1110的连接部位与所述支架瓣环在人工心脏瓣叶1000的轴向上的位置相同或大致相同。此外，所述闭合壁1120的高度还应大于1mm，即当所述人工心脏瓣叶1000位于所述闭合状态时，所述闭合壁1120沿人工心脏瓣叶1000的轴向上的长度大于1mm。另外，本发明对于闭合壁1120的形状并不做严格的限定，其平面展开形状可以是三角形，也可以是矩形，还可以是其他形状。还应说明的是，对于本领域技术人员而言，所述支架瓣环是所述支架2000与所述心脏中的瓣环相对应的位置，是本领域的公知常识。
请继续参阅图6a并结合图6b，当所述人工心脏瓣叶1000从所述闭合状态扩张至所述打开状态时，所述小叶1100沿径向外扩并靠近所述支架2000而具有弯折损伤的风险，对此，所述主体壁1110被设置为三部分。详细地，如图2所示，所述主体壁1110包括依次连接的接合壁1111、弯曲壁1112和延伸壁1113。其中，所述接合壁1111用于与所述支架2000的流入端2100连接，所述弯曲壁1112由弹性材料制成，且其在所述人工心脏瓣叶1000的轴向截面呈弧形，所述延伸壁1122与所述闭合壁1120连接。因所述弯曲壁1112具有弹性并且为弧形结构，小叶1110在外扩时具有较强的抗弯折能力，可有效提高小叶1110的耐久性，进而提高所述人工心脏瓣叶1000的使用寿命。另外，请参考图3，为确保人工心脏瓣叶1000的闭合效果，当所述人工心脏瓣叶1000位于所述打开状态时，相邻小叶1100的弯曲壁1112至少部分重叠，相邻小叶1100的延伸壁1113也应至少部分重叠。
请继续参考图2，所述小叶的接合壁1111与所述弯曲壁1112的周向尺寸相当，且两者的平面展开形状均可为矩形。所述延伸壁1113的平面展开形状可为梯形。当然，图2所示的小叶1100仅为一种具体形状，其并不是唯一的选择，例如，图4a和图4b示出了另外两种小叶1100的形状，其中图4a所示的小叶1100中，所述延伸壁1113的平面展开形状呈三角形，而在图4b所示的小叶1100中，所述延伸壁1113的平面展开形状为三角形，且所述接合壁1111的周向尺寸小于所述弯曲壁1112的周向尺寸。此外，还应理解的是，在本文所列举的各种小叶1100的结构中，所述延伸壁1113均为平直结构，实际上，延伸壁1113也可以是弧形结构。即，本发明实施例并不特别强调所述小 叶1100的形状，只要其能够满足在人工心脏瓣叶1000位于所述打开状态时，相邻小叶1100的弯曲壁1112至少部分重叠的同时，相邻小叶1100的延伸壁1113也至少部分重叠(即相邻小叶1100的主体壁1110部分重叠)即可。
为更好地实现所述人工心脏瓣叶1000的闭合效果，还可对所述小叶1100的各部分的坡度进行优化设计。这里所述的坡度是指，以所述接合壁1111远离所述弯曲壁1112的端面为基准面，所述小叶1100的各个部分与该基准面的夹角角度。详细地，如图5所示，所述延伸壁1113与所述基准面间的夹角为β，所述闭合壁1120与所述基准面间的夹角为α，且α>β；更优地，在轴向上所述接合壁1111与所述弯曲壁1112连接点处的切线与所述基准面间的夹角为θ，在轴向上所述弯曲壁1112与所述延伸壁1113的连接点处的切线与所述基准面间的夹角为γ，且α>γ>β,γ<θ，并且30°≤α≤90°，30°≤β≤90°，30°≤γ≤90°，60°≤θ≤90°。
此外，现有的各类人工心脏瓣叶均类似于天然的心脏瓣膜(即主动脉瓣、肺动脉瓣、二尖瓣及三尖瓣)，在植入心脏后需要与乳头肌相连以使人工心脏瓣叶的收缩和扩张皆受心脏的控制。具体而言，人工心脏瓣叶随心脏的收缩而扩张，并随心脏的舒张而闭合，即现有的人工心脏瓣叶的打开和闭合都只能在受力的情况下被动地进行。但是，在实际使用时，往往因人工心脏瓣叶的植入位置偏移而导致其不能很好地随心脏的舒张而闭合，从而出现轻度返流或局部返流情况，并引发人工心脏瓣叶闭合不全的问题。有鉴于此，本发明实施例所述的人工心脏瓣叶1000位于所述打开状态时，所述小叶1100被配置为解除外力后能够自动复位，以使所述人工心脏瓣叶1000恢复至所述闭合状态。具体地，所述的小叶1100可由弹性模量介于0.2GPa-2.5GPa的材料制成，如聚氨酯(PU)、聚乙烯(PE)等材料；或者，所述小叶1100也可由形状记忆材料制成，如镍钛合金等。如此，所述人工心脏瓣叶1000在不受外力作用时位于所述闭合状态，在将该人工心脏瓣叶1000植入心脏后可无需与乳头肌相连。当心脏收缩时血液流动并且在血液流动力的作用下，人工心脏瓣叶1000扩张，当心脏舒张时血液流动力消失，人工心脏瓣叶1000便可自动回缩至所述闭合状态。
进一步地，本发明实施例还提供了一种心脏瓣膜假体，包括：支架2000，具有相对的流入端2100和流出端2200；以及如前所述的人工心脏瓣叶1000，设置于所述支架2000的内表面，且所述主体壁1110与所述流入端2100连接。更为具体地，所述主体壁1110的接合壁1111与所述流入端2100连接。
如前所述，支架2000可以采用现有的任何一种支架，具体地，所述支架2000为网格状且其截面形状与所述人工心脏瓣叶1000相适应，例如，支架2000的截面呈圆形。所述支架2000的材质可以是本领域已知的具有生物相容性的塑性膨胀材料，例如医用不锈钢或钴铬合金，也可以是自膨胀性材料例如镍钛合金。支架2000可由管材切割而成，也可通过金属丝编织而成。所述人工心脏瓣叶1000的主体壁1110，具体为接合壁1111通过缝合或其他方式固定于所述支架2000的流入端2100，以使人工心脏瓣叶1000可通过支架2000植入心脏。
所述心脏瓣膜假体还可进一步地包括与所述支架2000的流入端2100相连接的裙边3000。当所述心脏瓣膜假体植入心脏代替天然心脏瓣膜，特别是代替二尖瓣或三尖瓣时，需要在支架2000的流入端2100设置裙边3000以防止瓣周漏的产生。
所述裙边3000可包括相互连接的内裙边3100和外裙边3200，其中所述内裙边3100设置于所述支架2000的内侧面，所述外裙边3200设置于所述支架2000的外侧面，所述内裙边3100和所述外裙边3200可为一体结构。作为优选，所述外裙边3200远离所述内裙边3100的边缘呈波浪形，以减少材料的用量。所述裙边3000的材质可以是本领域常规的医用高分子材料例如聚对苯二甲酸乙二醇酯(PET)，裙边3000可采用缝合、热覆合、胶粘等多种方式固定于所述支架2000上。
接下来本文以将所述心脏瓣膜假体植入心脏以代替三尖瓣控制右心房和右心室之间的血流为例来介绍所述心脏瓣膜假体的详细工作方式。
首先，采用常规方法将所述心脏瓣膜假体输送至工作位置，并膨胀至工作尺寸，且所述支架2000的流入端2100朝向右心房，所述支架2000的流出端2200朝向右心室。
当心脏舒张，血液从右心室泵送至肺时，人工心脏瓣叶1000位于所述闭合状态，以避免血液返流至右心房。在这期间，更多的血液进入右心房。随后，心脏收缩，右心房内的血液流动，人工心脏瓣叶1000在血液流动力的作用下沿径向向外扩张至所述打开状态，血液流入右心室。之后，心脏舒张，人工心脏瓣叶1000因其小叶1100自身的结构和材料的作用而自动恢复至所述闭合状态。
本发明实施例中的人工心脏瓣叶1000和心脏瓣膜假体，通过在小叶1100上设置闭合壁1120，并且采用层层叠置的方式布置所述小叶1100以形成人工心脏瓣叶1000，保证了人工心脏瓣叶1000具有良好的闭合性，可有效防止返流，降低形成较大跨瓣压差的可能性，提高人工心脏瓣叶1000的工作效果。更进一步地，通过采用弹性模量大于0.2GPa的弹性材料或形状记忆材料制备小叶1100，使得人工心脏瓣叶1000可以自动复位至所述闭合状态，从而避免因植入位置偏差而引起的返流问题。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (14)

  1. 一种人工心脏瓣叶，其特征在于，包括分布成环形的至少两个小叶，且每个所述小叶包括在轴向上连接的主体壁和闭合壁；其中：
    所述人工心脏瓣叶具有闭合状态和打开状态；
    所述至少两个小叶被配置为当所述人工心脏瓣叶位于所述打开状态时，所述至少两个小叶的闭合壁分离；
    所述至少两个小叶还被配置为当所述人工心脏瓣叶位于所述闭合状态时，相邻的所述小叶的主体壁至少部分重叠以使所述人工心脏瓣叶的周向封闭，同时相邻的所述小叶的闭合壁至少部分重叠以使所述人工心脏瓣叶的轴向的至少一端封闭。
  2. 根据权利要求1所述的人工心脏瓣叶，其特征在于，所述至少两个小叶还被配置为当所述人工心脏瓣叶位于所述打开状态时，相邻的所述小叶的主体壁至少部分重叠。
  3. 根据权利要求1或2所述的人工心脏瓣叶，其特征在于，当所述人工心脏瓣叶位于所述闭合状态时，所述人工心脏瓣叶呈漏斗状结构且相邻的所述小叶的闭合壁至少部分重叠以封闭所述漏斗状结构的尖端封闭。
  4. 根据权利要求1或2所述的人工心脏瓣叶，其特征在于，所述至少两个小叶被配置为在外力作用下闭合壁分离而使所述人工心脏瓣叶位于所述打开状态，并且所述至少两个小叶在外力解除后能够自动复位而使闭合壁至少部分重叠，以使所述人工心脏瓣叶能够从所述打开状态恢复至所述闭合状态。
  5. 根据权利要求4所述的人工心脏瓣叶，其特征在于，每个所述小叶的弹性模量大于0.2GPa-2.5GPa。
  6. 根据权利要求4所述的人工心脏瓣叶，其特征在于，每个所述小叶由形状记忆材料制成。
  7. 根据权利要求2所述的人工心脏瓣叶，其特征在于，每个所述主体壁包括在轴向上依次连接的接合壁、弯曲壁和延伸壁；所述弯曲壁在所述人工心脏瓣叶的轴向截面呈弧形；所述延伸壁与所述闭合壁连接；
    当所述人工心脏瓣叶位于所述打开状态时，相邻的所述小叶的弯曲壁至少部分重叠，相邻的所述小叶的延伸壁至少部分重叠。
  8. 根据权利要求7所述的人工心脏瓣叶，其特征在于，以所述接合壁远离所述弯曲壁的端面为基准面，所述延伸壁与所述基准面间的夹角为β，所述闭合壁与所述基准面间的夹角为α，且α>β。
  9. 根据权利要求8所述的人工心脏瓣叶，其特征在于，所述接合壁与所述弯曲壁连接点处的切线与所述基准面间的夹角为θ，所述弯曲壁与所述延伸壁的连接点处的切线与所述基准面间的夹角为γ，且α>γ>β，γ<θ。
  10. 根据权利要求9所述的人工心脏瓣叶，其特征在于，30°≤α≤90°，30°≤β≤90°，30°≤γ≤90°，60°≤θ≤90°。
  11. 一种心脏瓣膜假体，其特征在于，包括：
    支架，具有相对的流入端和流出端；以及
    如权利要求1-10中任一项所述的人工心脏瓣叶，设置于所述支架内，且所述人工心脏瓣叶的主体壁与所述支架连接。
  12. 根据权利要求11所述的心脏瓣膜假体，其特征在于，所述主体壁包括在轴向上依次连接的接合壁、弯曲壁和延伸壁，其中所述接合壁与所述支架的流入端连接。
  13. 根据权利要求11或12所述的心脏瓣膜假体，其特征在于，所述支架具有与心脏的瓣环相对应的支架瓣环位置，当所述人工心脏瓣叶位于所述闭合状态时，所述主体壁与所述人工心脏瓣叶的闭合壁的连接位置与所述支架瓣环位置相对应。
  14. 根据权利要求11或12所述的心脏瓣膜假体，其特征在于，所述心脏瓣膜假体还包括裙边，所述裙边包括相连的内裙边和外裙边；所述内裙边设置于所述支架的流入端的内侧面；所述外裙边设置于所述支架的流入端的外侧面，且所述外裙边远离所述内裙边的边缘呈波浪形。
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