CN112190365A - Artificial heart valve leaflet and heart valve prosthesis - Google Patents
Artificial heart valve leaflet and heart valve prosthesis Download PDFInfo
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- CN112190365A CN112190365A CN201910611275.1A CN201910611275A CN112190365A CN 112190365 A CN112190365 A CN 112190365A CN 201910611275 A CN201910611275 A CN 201910611275A CN 112190365 A CN112190365 A CN 112190365A
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- heart valve
- valve leaflet
- wall
- leaflet
- prosthetic heart
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- 239000000463 material Substances 0.000 description 6
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- 230000000747 cardiac effect Effects 0.000 description 4
- 230000008602 contraction Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 210000000591 tricuspid valve Anatomy 0.000 description 4
- 238000002513 implantation Methods 0.000 description 3
- 210000004115 mitral valve Anatomy 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 206010018910 Haemolysis Diseases 0.000 description 2
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- 230000006870 function Effects 0.000 description 2
- 210000005240 left ventricle Anatomy 0.000 description 2
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Images
Classifications
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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
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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
The invention relates to a prosthetic heart valve leaflet and a heart valve prosthesis, which comprise at least two small leaves distributed in a ring shape, wherein each small leaf comprises a main body wall and a closing wall which are connected in the axial direction; wherein: the artificial heart valve leaflet has a closed state and an open state; the leaflets are configured such that when the prosthetic heart valve leaflet is in the open state, the closed walls of the leaflets separate; the leaflets are further configured such that when the prosthetic heart valve leaflet is in the closed state, body walls of adjacent leaflets at least partially overlap to cause circumferential closure of the prosthetic heart valve leaflet while closure walls of adjacent leaflets at least partially overlap to cause axial closure of the prosthetic heart valve leaflet. The artificial heart valve leaflet has the advantage that the artificial heart valve leaflet can be completely closed so as to reduce the generation of large trans-valve pressure difference.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an artificial heart valve leaflet and a heart valve prosthesis.
Background
The heart valve includes an aortic valve that joins the left ventricle and the aorta, a pulmonary valve that joins the right ventricle and the pulmonary artery, a mitral valve that joins the left atrium and the left ventricle, and a tricuspid valve that joins the right atrium and the right ventricle. All the heart valves play the role of one-way valves, and the heart valves are opened and closed rhythmically along with the rhythmic contraction and relaxation of the heart in the blood circulation, so that the blood smoothly passes through the valve openings and is prevented from flowing backwards, and the blood circularly flows in a certain direction in the body. When the heart valve is inflamed, the problems of structural damage, fibrosis, adhesion, shortening, myxoma-like lesion, ischemic necrosis, calcium precipitation and the like can be caused, and the normal blood circulation is influenced, so that the heart valve disease is called.
Prosthetic heart valve leaflets are artificial organs that can be implanted into the heart to work in place of heart valves. When the heart valve is seriously ill and cannot be restored and the valve function is improved by adopting valve separation or repair, artificial heart valve replacement is necessary. However, the existing artificial heart valve leaflet still has the problems of insufficient closure height and insufficient leaflet coaptation area, which cause the insufficiency of the artificial heart valve leaflet. When the artificial heart valve leaflet is not completely closed, partial blood backflow can be caused, and large trans-valve pressure difference is caused, and the trans-valve pressure difference is an important hemodynamic parameter for evaluating the function of the artificial heart valve leaflet. Specifically, after the artificial cardiac valve leaflet is implanted into a human body, when blood flows through a valve orifice, the blocking effect of the artificial cardiac valve leaflet on the blood flow generates a trans-valve pressure difference, the greater the velocity gradient of the blood flow, and the shear stress generated by the trans-valve pressure difference is increased, and once the shear stress exceeds a threshold value for damaging blood components, hemolysis or sub-hemolysis can be caused, and even vascular endothelial cells can be damaged.
Disclosure of Invention
The invention aims to provide an artificial heart valve leaflet and a heart valve prosthesis, which can be fully closed to avoid backflow and further avoid generating large trans-valve pressure difference.
In order to achieve the above objects, the present invention provides a prosthetic heart valve leaflet comprising at least two leaflets distributed in a ring shape, and each of the leaflets comprises a main body wall and a closing wall connected in an axial direction; wherein:
the artificial heart valve leaflet has a closed state and an open state;
the leaflets are configured such that when the prosthetic heart valve leaflet is in the open state, the closed walls of the leaflets separate;
the leaflets are further configured such that when the prosthetic heart valve leaflet is in the closed state, body walls of adjacent leaflets at least partially overlap to cause circumferential closure of the prosthetic heart valve leaflet while closure walls of adjacent leaflets at least partially overlap to cause axial closure of the prosthetic heart valve leaflet.
Optionally, the leaflets are further configured such that when the prosthetic heart valve leaflet is in the open state, body walls of adjacent leaflets at least partially overlap.
Optionally, when the artificial heart valve leaflet is in the closed state, the artificial heart valve leaflet is in a funnel-shaped structure and the closing walls of adjacent leaflets at least partially overlap to close the tips of the funnel-shaped structure.
Optionally, the leaflets are configured to be automatically repositioned upon release of the external force to enable the prosthetic heart valve leaflet to return from the open state to the closed state.
Optionally, the leaflets are configured to be automatically contractible upon release of an external force to enable the prosthetic heart valve leaflet to return from the open state to the closed state.
Optionally, the leaflet has an elastic modulus of 0.2GPa to 2.5 GPa.
Optionally, the leaflets are made of a shape memory material.
Optionally, the body wall comprises an engaging wall, a curved wall and an extending wall connected in sequence in the axial direction; the curved wall is arc-shaped in the axial section of the artificial heart valve leaflet; the extension wall is connected with the closing wall;
when the artificial heart valve leaflet is in the open state, the curved walls of adjacent leaflets at least partially overlap and the extended walls of adjacent leaflets at least partially overlap.
Optionally, an end surface of the engaging wall away from the curved wall is taken as a reference surface, an included angle between the extending wall and the reference surface is β, an included angle between the closing wall and the reference surface is α, and α > β.
Optionally, an angle between a tangent line at a connection point of the joining wall and the curved wall and the reference plane is θ, an angle between a tangent line at a connection point of the curved wall and the extending wall and the reference plane is γ, and α > γ > β, γ < θ.
Optionally, alpha is more than or equal to 30 degrees and less than or equal to 90 degrees, beta is more than or equal to 30 degrees and less than or equal to 90 degrees, gamma is more than or equal to 30 degrees and less than or equal to 90 degrees, and theta is more than or equal to 60 degrees and less than or equal to 90 degrees.
Further, to achieve the above object, the present invention provides a heart valve prosthesis comprising:
a stent having opposing inflow and outflow ends; and
the artificial heart valve leaflet is arranged in the bracket, and the main body wall is connected with the bracket.
Optionally, the body wall includes an engagement wall, a curved wall, and an extension wall connected in series in the axial direction, wherein the engagement wall is connected with the inflow end of the holder.
Optionally, the stent has a stent annulus position corresponding to an annulus of a heart, and the attachment position of the body wall and the closure wall corresponds to the stent annulus position when the prosthetic heart valve leaflet is in the closed state.
Optionally, the skirt comprises an inner skirt and an outer skirt which are connected with each other; the inner skirt is arranged on the inner side surface of the inflow end of the bracket; the outer skirt edge is arranged on the outer side surface of the inflow end of the support, and the edge of the outer skirt edge is wavy.
Compared with the prior art, the artificial heart valve leaflet and the heart valve prosthesis have the following advantages:
first, the artificial heart valve leaflet of the present invention comprises at least two leaflets, and each leaflet has a main body wall and a closing wall arranged in sequence from an inflow end to an outflow end of a heart valve prosthesis, wherein when the artificial heart valve leaflet is in a closed state, the main body walls of adjacent leaflets at least partially coincide, and the closing walls of adjacent leaflets also at least partially overlap such that the artificial heart valve leaflet is closed.
Second, when the heart valve is in the open position, the body walls of adjacent leaflets still partially overlap, which ensures complete closure of the heart valve in the closed position.
Thirdly, the leaflets of the invention can be automatically restored after the external force is relieved, so that the artificial heart valve leaflet can be automatically closed, and the problem of incomplete closure caused by the deviation of the implantation position can be avoided. For this purpose, the leaflets are preferably made of a material having an elastic modulus of 0.2GPa to 2.5GPa or a shape memory material so that the prosthetic heart valve leaflet automatically returns to the closed state after opening following contraction of the heart.
Fourthly, the connecting position of the main body wall and the closing wall is equivalent to the position of a bracket valve ring of the bracket, which is beneficial to improving the closing height of the artificial heart valve leaflet and further improving the closing performance of the artificial heart valve leaflet.
Drawings
Fig. 1a is a top view of a prosthetic heart valve leaflet according to an embodiment of the present invention, illustrating the prosthetic heart valve leaflet in a closed state;
fig. 1b is a top view of the prosthetic heart valve leaflet of fig. 1a in an open state;
fig. 2 is a schematic structural view of leaflets of the artificial heart valve leaflet according to an embodiment of the present invention;
FIG. 3 is a schematic structural view of the leaflets shown in FIG. 1a being stacked to form a prosthetic heart valve leaflet;
FIGS. 4a and 4b are schematic structural views of leaflets provided in accordance with an embodiment of the invention;
FIG. 5 is a schematic illustration of the slope relationship of leaflets provided by the invention according to an embodiment;
fig. 6a is a schematic structural view of a heart valve prosthesis according to an embodiment of the invention, in which the artificial heart valve leaflets are in a closed state;
fig. 6b is a schematic structural view of a heart valve prosthesis according to an embodiment of the invention, in which the artificial heart valve leaflet is in an open state;
FIG. 7 is a schematic diagram of the construction of a skirt of a heart valve prosthesis according to one embodiment of the present invention.
In the figure:
1000-artificial heart valve leaflet;
1100-leaflets; 1100 a-first leaflet, 1100 b-second leaflet, 1100 c-third leaflet, 1140 d-fourth leaflet;
1110-a body wall;
1111-mating wall, 1112-curved wall, 1113-extension wall;
1120-a closure wall;
2000-bracket;
2100-inflow end, 2200-outflow end;
3000-skirt;
3100 inner skirt, 3200 outer skirt.
Detailed Description
In order to make the objects, advantages and features of the present invention more apparent, embodiments of the artificial heart valve leaflet and the heart valve prosthesis according to the present invention will be described in detail with reference to the accompanying drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.
As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents, and the plural forms "a plurality" includes two or more referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations. The same or similar reference numbers in the drawings identify the same or similar elements.
The leaflets mentioned in the following description, unless stated as native leaflets, refer uniformly to prosthetic heart leaflets.
Referring to fig. 1a and 1b in conjunction with fig. 2 and 3, an artificial heart valve leaflet 1000 according to an embodiment of the present invention has an open state and a closed state, wherein the artificial heart valve leaflet 1000 shown in fig. 1a is in the closed state, and the artificial heart valve leaflet 1000 shown in fig. 1b is in the open state.
Specifically, the artificial cardiac leaflet 1000 includes at least two leaflets 1100 arranged in a ring shape, each of the leaflets 1100 includes a main body wall 1110 and a closing wall 1120 that are sequentially connected in an axial direction, where the main body wall 1110 and the closing wall 1120 are sequentially arranged from an inflow end to an outflow end of the artificial cardiac leaflet prosthesis, that is, the "axial direction" refers to a direction parallel to a blood flow direction after the artificial cardiac leaflet 1000 is implanted into a heart. The ring shape may have a regular shape such as a circle, a rectangle, a regular polygon, or other irregular shapes, and for convenience of understanding, a circle is illustrated in this embodiment, and thus, a direction perpendicular to the blood flow direction is a radial direction of the artificial heart valve leaflet 1000. In the following description, the artificial heart valve leaflet of the present embodiment is explained assuming that the leaflet 1100 is more than two and at least two leaflets 1100 are arranged in a circular shape, but this should not be construed as limiting the present invention.
When the prosthetic heart valve leaflet 1000 is in the open state, the closing walls 1120 of the leaflets 1100 are separated from each other without overlapping. And when the prosthetic heart valve leaflet 1000 is in the closed state, the closing walls 1120 of the leaflets 1100 are brought closer together to at least partially overlap the main body walls 1110 of the leaflets to thereby cause circumferential closure of the prosthetic heart valve leaflet 1000, while the closing walls 1120 of any adjacent leaflets 1100 are at least partially overlapped to cause axial closure of the prosthetic heart valve leaflet 1000. It is understood that "overlap" herein refers to a state in which any adjacent leaflets 1100 are superposed and attached to each other.
Further, when the prosthetic heart valve leaflet 1000 is in the open state, the main body walls 1110 of any adjacent leaflets 1100 partially overlap, so that when the prosthetic heart valve leaflet 1000 is in the closed state, it can be ensured that it is reliably closed circumferentially. Preferably, when the prosthetic heart valve leaflet 1000 is in the closed state, the prosthetic heart valve leaflet 1000 forms a funnel-shaped structure, when the closing walls 1120 of any two adjacent leaflets 1000 at least partially overlap to close the tips of the funnel-shaped structure.
Fig. 3 shows the positional relationship of a part of the leaflet 1100 when the artificial heart valve leaflet 1000 is in the open state. More specifically in conjunction with fig. 3, the four leaflets 1100 are arranged about a central axis and are circumferentially stacked, such that, when viewed from the direction from the closure wall 1120 toward the main body wall 1110, the four leaflets 1100 are identified as a first leaflet 1100a, a second leaflet 1100b, a third leaflet 1100c, and a fourth leaflet 1100d, respectively, in a clockwise order. The second leaflet 1100b is positioned outside the first leaflet 1100a during the opening or closing of the prosthetic heart valve leaflet 1000, and a portion of the second leaflet 1100b always overlaps the first leaflet 1100 a; the third leaflet 1100c is outside the second leaflet 1100b, and a portion of the third leaflet 1100c always overlaps the second leaflet 1100 b; the fourth leaflet 1100d is located outside the third leaflet 1100c, and a part of the fourth leaflet 1100d always overlaps the third leaflet 1100c, and so on, until the ends of the main body walls 1110 of all the leaflets 1100 far from the closing wall 1120 form a ring to form a complete artificial heart valve leaflet 1000. When the prosthetic heart valve leaflet 1000 is contracted to the closed state, the closing walls 1120 of the leaflets 1100 are close to each other and the closing walls 1120 of the adjacent leaflets 1100 are partially overlapped until the prosthetic heart valve leaflet 1000 forms a funnel-shaped structure with closed periphery and closed tip, at which time the overlapping area of the main body walls 1110 of the adjacent leaflets 1100 is larger than that of the main body walls 1110 of the adjacent leaflets 1100 in the open state.
In the embodiment of the present invention, on the one hand, when the artificial heart valve leaflet 1000 is in the open state, there is still a partial overlap between the main body walls 1110 of the adjacent leaflets 1100, so as to ensure that the adjacent main body walls 1110 have a sufficient coaptation area when the artificial heart valve leaflet 1000 is in the closed state to ensure the closing effect of the artificial heart valve leaflet 1000 in the circumferential direction; on the other hand, when the artificial cardiac valve leaflet 1000 is in the closed state, because the main body wall 1110 has a certain thickness, the tip of the funnel-shaped structure formed by the main body wall 1110 has a small hole, and by providing the closing wall 1120 on the leaflet 1100, the adjacent closing walls 1120 can block the small hole when being overlapped in sequence, and the closing wall 1120 can also increase the closing height of the artificial cardiac valve leaflet 1000, further improve the closing performance of the artificial cardiac valve leaflet 1000 in the axial direction, so that the artificial cardiac valve leaflet 1000 can be completely closed, thereby effectively preventing blood from flowing back and avoiding generating a large trans-valve pressure difference. It should be understood that the "height" mentioned herein refers to a length in the axial direction of the artificial heart valve leaflet 1000.
Preferably, the leaflets 1100 form an arcuate configuration in the circumferential direction, and the overlapping portions of the body walls 1110 can better conform when the leaflets 1100 are stacked and collapsed to the closed position to improve the closing effect.
As shown in fig. 6a, in practice, the artificial heart valve leaflet 1000 is implanted into the heart through the stent 2000. The stent 2000 has an inflow end 2100 and an outflow end 2200, wherein the inflow end 2100 refers to an inlet end of blood and the outflow end 2200 refers to an outlet end of blood. The artificial heart valve leaflet 1000 is disposed on the inner side of the stent 2000, and one end of the main body wall 1110 of each leaflet 1100, which is away from the closing wall 1120, is connected to the inflow end 2100 of the stent 2000. The stent 2000 used in embodiments of the present invention may be any of the existing stents.
Generally, the closed height of the prosthetic heart valve leaflet 1000 is at least 3mm, and in order to ensure the closed height of the prosthetic heart valve leaflet 1000, the height of the connection position of the closing wall 1120 and the main body wall 1110 when the prosthetic heart valve leaflet 1000 is in the closed state should be equivalent to the height of the stent annulus 2300. In other words, when the prosthetic heart valve leaflet 1000 is in the closed state, the connection site of the closing wall 1120 and the main body wall 1110 is the same or substantially the same as the position of the stent annulus in the axial direction of the prosthetic heart valve leaflet 1000. In addition, the height of the closing wall 1120 should be greater than 1mm, that is, the length of the closing wall 1120 in the axial direction of the prosthetic heart valve leaflet 1000 is greater than 1mm when the prosthetic heart valve leaflet 1000 is in the closed state. In addition, the shape of the closing wall 1120 is not strictly limited, and the planar expansion shape may be a triangle, a rectangle, or other shapes. It should also be noted that the stent annulus is the location of the stent 2000 corresponding to the annulus in the heart and is well known to those skilled in the art.
With continued reference to fig. 6a in conjunction with fig. 6b, when the prosthetic heart valve leaflet 1000 expands from the closed state to the open state, the leaflets 1100 expand radially outward and close to the stent 2000 with risk of bending damage, for which the body wall 1110 is provided in three parts. In detail, as shown in fig. 2, the body wall 1110 includes an engaging wall 1111, a curved wall 1112, and an extending wall 1113, which are connected in sequence. Wherein the engagement wall 1111 is adapted to be connected to the inflow end 2100 of the stent 2000, the curved wall 1112 is made of an elastic material and has an arc shape in an axial section of the prosthetic heart valve leaflet 1000, and the extension wall 1122 is connected to the closing wall 1120. Because the curved wall 1112 has elasticity and is an arc-shaped structure, the leaflet 1110 has stronger bending resistance when being expanded, the durability of the leaflet 1110 can be effectively improved, and the service life of the artificial heart valve leaflet 1000 is further prolonged. In addition, referring to fig. 3, in order to ensure the closing effect of the artificial heart valve leaflet 1000, when the artificial heart valve leaflet 1000 is in the open state, the curved walls 1112 of the adjacent leaflets 1100 at least partially overlap, and the extension walls 1113 of the adjacent leaflets 1100 should also at least partially overlap.
With continued reference to fig. 2, the engagement wall 1111 of the leaflet is comparable in circumferential dimension to the curved wall 1112, and both may be rectangular in planar development. The planar development shape of the extension wall 1113 may be trapezoidal. Of course, the leaflet 1100 shown in fig. 2 is only one specific shape and is not the only choice, for example, fig. 4a and 4b show the shapes of two other leaflets 1100, wherein in the leaflet 1100 shown in fig. 4a the planar development of the extension wall 1113 is triangular, whereas in the leaflet 1100 shown in fig. 4b the planar development of the extension wall 1113 is triangular and the axial dimension of the coaptation wall 1111 is smaller than the circumferential dimension of the curved wall 1112. Further, it is to be understood that in the various leaflet 1100 configurations illustrated herein, the extension walls 1112 are each axially straight, and in fact, the extension walls 1112 can also be axially arcuate. That is, the shape of the leaflet 1100 is not particularly emphasized in the embodiments of the present invention, as long as it can satisfy that the curved walls 1112 of the adjacent leaflets 1100 at least partially overlap and the extension walls 1113 of the adjacent leaflets 1100 also at least partially overlap (i.e., the main body walls 1110 of the adjacent leaflets 1100 partially overlap) when the artificial heart valve leaflet 1000 is in the open state.
In order to better achieve the closing effect of the prosthetic heart valve leaflet 1000, the slopes of the respective portions of the leaflet 1100 may also be optimally designed. The slope here refers to an angle between each portion of the leaflet 1100 and a reference plane, which is an end surface of the joining wall 1111 away from the curved wall 1112. In detail, as shown in fig. 5, an included angle between the extension wall and the reference plane is β, an included angle between the closing wall and the reference plane is α, and α > β; more preferably, an angle between a tangent line at a connecting point of the engaging wall and the curved wall and the reference plane is θ, an angle between a tangent line at a connecting point of the curved wall and the extending wall and the reference plane is γ, and α > γ > β, γ < θ, and α ≦ 30 ° or more and ≦ 90 °, β ≦ 30 ° or more and ≦ 90 °, θ ≦ 60 ° or more and ≦ 90 °.
In addition, each of the existing artificial heart valve leaflets is similar to a natural heart valve (i.e., aortic valve, pulmonary valve, mitral valve, and tricuspid valve), and needs to be connected with papillary muscles after being implanted into the heart so that the contraction and expansion of the artificial heart valve leaflets are controlled by the heart. Specifically, the artificial heart valve leaflet expands with the contraction of the heart and closes with the relaxation of the heart, i.e., the existing artificial heart valve leaflet can only open and close passively under the condition of force. However, in actual use, the artificial cardiac valve leaflet is often not closed well along with the diastole of the heart due to the deviation of the implantation position of the artificial cardiac valve leaflet, so that light reflux or local reflux occurs, and the problem of incomplete closure of the artificial cardiac valve leaflet is caused. In view of this, when the artificial heart valve leaflet 1000 according to the embodiment of the present invention is in the open state, the leaflet 1100 is configured to be automatically repositioned after the external force is removed, so that the artificial heart valve leaflet 1000 is restored to the closed state. Specifically, the leaflet 1100 can be made of a material with an elastic modulus between 0.2GPa and 2.5GPa, such as Polyurethane (PU), Polyethylene (PE), etc.; alternatively, the leaflets 1100 can be made of a shape memory material, such as nitinol or the like. In this manner, the artificial heart valve leaflet 1000 is in the closed state when not subjected to an external force, and the artificial heart valve leaflet 1000 may not need to be connected to papillary muscles after being implanted into the heart. When the heart contracts, the blood flows and the artificial cardiac valve 1000 expands under the action of the blood flow force, and when the heart relaxes, the blood flow force disappears and the artificial cardiac valve 1000 automatically retracts to the closed state.
Further, embodiments of the present invention also provide a heart valve prosthesis, including: a stent 2000 having opposing inflow and outflow ends 2100, 2200; and the artificial heart valve leaflet 1000 as described above, which is disposed on the inner surface of the stent 2000, and the body wall 1110 is connected to the inflow end 2100. More specifically, the engagement wall 1111 of the body wall 1110 is connected to the inflow end 2100.
As described above, the stent 2000 may be any one of existing stents, and in particular, the stent 2000 has a mesh shape and a cross-sectional shape corresponding to the artificial heart valve leaflet 1000, for example, the stent 2000 has a circular cross-section. The stent 2000 may be made of a biocompatible plastic expandable material known in the art, such as medical stainless steel or cobalt-chromium alloy, or may be a self-expandable material such as nitinol. The stent 2000 may be cut from tubing or braided from wire. The main body wall 1110, specifically, the coaptation wall 1111, of the artificial heart valve leaflet 1000 is fixed to the inflow end 2100 of the stent 2000 by suturing 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 coupled to the inflow end 2100 of the stent 2000. When the heart valve prosthesis is implanted in a heart to replace a native heart valve, particularly a mitral valve or a tricuspid valve, a skirt 3000 is 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 which are connected to each other, wherein the inner skirt 3100 is disposed on an inner side of the bracket 2000, the outer skirt 3200 is disposed on an outer side of the bracket 2000, and the inner skirt 3100 and the outer skirt 3200 may be integrated. Preferably, the edge of the outer skirt 3200 remote from the inner skirt 3100 is undulated to reduce the amount of material used. The skirt 3000 may be made of a medical polymer material such as polyethylene terephthalate (PET), which is conventional in the art, and the skirt 3000 may be fixed to the frame 2000 by various methods such as sewing, heat-bonding, and gluing.
The detailed operation of the heart valve prosthesis will be described herein below by way of example in which the heart valve prosthesis is implanted in the heart to control blood flow between the right atrium and the right ventricle in place of the tricuspid valve.
First, the heart valve prosthesis is delivered to the working position and expanded to the working size using conventional methods, with the inflow end 2100 of the stent 2000 facing the right atrium and the outflow end 2200 of the stent 2000 facing the right ventricle.
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 prevent blood from flowing back to the right atrium. During this time, 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 by the blood flow force, and the blood flows into the right ventricle. Thereafter, the heart relaxes, and the artificial cardiac leaflet 1000 automatically returns to the closed state due to the structure and material of the leaflet 1100 itself.
According to the artificial heart valve leaflet 1000 and the heart valve prosthesis in the embodiment of the invention, the closed wall 1120 is arranged on the leaflet 1100, and the leaflet 1100 is arranged in a layer-by-layer overlapping manner to form the artificial heart valve leaflet 1000, so that the artificial heart valve leaflet 1000 has good closure performance, backflow can be effectively prevented, the possibility of forming a large trans-valve pressure difference is reduced, and the working effect of the artificial heart valve leaflet 1000 is improved. Further, by preparing the leaflet 1100 from an elastic material or a shape memory material having an elastic modulus greater than 0.2GPa, the prosthetic heart valve leaflet 1000 can be automatically returned to the closed state, thereby avoiding the problem of regurgitation due to deviation in the implantation position.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (14)
1. A prosthetic heart valve leaflet comprising at least two leaflets distributed in an annular shape, and each of the leaflets comprising a main body wall and a closing wall connected in an axial direction; wherein:
the artificial heart valve leaflet has a closed state and an open state;
the leaflets are configured such that when the prosthetic heart valve leaflet is in the open state, the closed walls of the leaflets separate;
the leaflets are further configured such that when the prosthetic heart valve leaflet is in the closed state, body walls of adjacent leaflets at least partially overlap to cause circumferential closure of the prosthetic heart valve leaflet while closure walls of adjacent leaflets at least partially overlap to cause axial closure of the prosthetic heart valve leaflet.
2. The prosthetic heart valve leaflet of claim 1, wherein the leaflets are further configured such that when the prosthetic heart valve leaflet is in the open state, body walls of adjacent leaflets at least partially overlap.
3. The prosthetic heart valve leaflet as claimed in claim 1 or 2, wherein the prosthetic heart valve leaflet has a funnel-shaped structure and the closing walls of adjacent leaflets at least partially overlap to close the tips of the funnel-shaped structure when the prosthetic heart valve leaflet is in the closed state.
4. The prosthetic heart valve leaflet of claim 1 or 2, wherein the leaflet is configured to be automatically repositioned after release of the external force to enable the prosthetic heart valve leaflet to return from the open state to the closed state.
5. The prosthetic heart valve leaflet of claim 4, wherein the leaflet has an elastic modulus of 0.2GPa to 2.5 GPa.
6. The prosthetic heart valve leaflet of claim 4, wherein the leaflet is made of a shape memory material.
7. The prosthetic heart valve leaflet as claimed in claim 2, wherein the main body wall includes a joining wall, a curved wall and an extending wall which are connected in this order in the axial direction; the curved wall is arc-shaped in the axial section of the artificial heart valve leaflet; the extension wall is connected with the closing wall;
when the artificial heart valve leaflet is in the open state, the curved walls of adjacent leaflets at least partially overlap and the extended walls of adjacent leaflets at least partially overlap.
8. The prosthetic heart valve leaflet as claimed in claim 7, wherein the end surface of the coaptation wall away from the curved wall is a reference plane, the angle between the extension wall and the reference plane is β, the angle between the closure wall and the reference plane is α, and α > β.
9. The prosthetic heart valve leaflet as claimed in claim 8, wherein an angle between a tangent line at a connection point of the coaptation wall and the curved wall and the reference plane is θ, an angle between a tangent line at a connection point of the curved wall and the extension wall and the reference plane is γ, and α > γ > β, γ < θ.
10. The artificial heart valve leaflet as claimed in claim 9, wherein α is 30 ° or more and 90 ° or less, β is 30 ° or more and 90 ° or less, γ is 30 ° or more and 90 ° or less, and θ is 60 ° or more and 90 ° or less.
11. A heart valve prosthesis, comprising:
a stent having opposing inflow and outflow ends; and
the prosthetic heart valve leaflet of any one of claims 1-10, disposed within the stent and the body wall is coupled to the stent.
12. The heart valve prosthesis of claim 11, wherein the body wall comprises a coaptation wall, a curved wall, and an extension wall sequentially connected in an axial direction, wherein the coaptation wall is connected to the inflow end of the stent.
13. The heart valve prosthesis of claim 11 or 12, wherein the body wall has a stent annulus position corresponding to an annulus of a heart, and wherein the attachment position of the body wall to the closure wall corresponds to the stent annulus position when the prosthetic heart valve leaflet is in the closed state.
14. The heart valve prosthesis of claim 11 or 12, further comprising a skirt comprising an inner skirt and an outer skirt connected to each other; the inner skirt is arranged on the inner side surface of the inflow end of the bracket; the outer skirt edge is arranged on the outer side surface of the inflow end of the support, and the edge of the outer skirt edge, which is far away from the inner skirt edge, is wavy.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910611275.1A CN112190365A (en) | 2019-07-08 | 2019-07-08 | Artificial heart valve leaflet and heart valve prosthesis |
| PCT/CN2020/100712 WO2021004462A1 (en) | 2019-07-08 | 2020-07-07 | Artificial heart valve leaflet and heart valve prosthesis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910611275.1A CN112190365A (en) | 2019-07-08 | 2019-07-08 | Artificial heart valve leaflet and heart valve prosthesis |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112190365A true CN112190365A (en) | 2021-01-08 |
Family
ID=74004281
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910611275.1A Withdrawn CN112190365A (en) | 2019-07-08 | 2019-07-08 | Artificial heart valve leaflet and heart valve prosthesis |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN112190365A (en) |
| WO (1) | WO2021004462A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115778635A (en) * | 2023-01-30 | 2023-03-14 | 上海蓝帆博奥医疗科技有限公司 | Artificial heart valve |
| CN117547383A (en) * | 2024-01-12 | 2024-02-13 | 佰仁医疗(江苏)有限公司 | Aortic prosthetic heart valve |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1729687A4 (en) * | 2004-01-22 | 2007-05-02 | Advanced Surgical Design & Man | Heart valve |
| US8257434B2 (en) * | 2007-12-18 | 2012-09-04 | Cormatrix Cardiovascular, Inc. | Prosthetic tissue valve |
| EP3007652A2 (en) * | 2013-06-14 | 2016-04-20 | Hazu GmbH | Method and device for treatment of valve regurgitation |
| WO2015038458A1 (en) * | 2013-09-12 | 2015-03-19 | St. Jude Medical, Cardiology Division, Inc. | Stent designs for prosthetic heart valves |
| CN210990935U (en) * | 2019-07-08 | 2020-07-14 | 上海微创心通医疗科技有限公司 | Artificial heart valve leaflet and heart valve prosthesis |
-
2019
- 2019-07-08 CN CN201910611275.1A patent/CN112190365A/en not_active Withdrawn
-
2020
- 2020-07-07 WO PCT/CN2020/100712 patent/WO2021004462A1/en active Application Filing
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115778635A (en) * | 2023-01-30 | 2023-03-14 | 上海蓝帆博奥医疗科技有限公司 | Artificial heart valve |
| CN115778635B (en) * | 2023-01-30 | 2023-05-26 | 上海蓝帆博奥医疗科技有限公司 | Artificial heart valve |
| CN117547383A (en) * | 2024-01-12 | 2024-02-13 | 佰仁医疗(江苏)有限公司 | Aortic prosthetic heart valve |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2021004462A1 (en) | 2021-01-14 |
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