CN116570404B - Valve support and artificial heart valve prosthesis - Google Patents
Valve support and artificial heart valve prosthesis Download PDFInfo
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- CN116570404B CN116570404B CN202310855564.2A CN202310855564A CN116570404B CN 116570404 B CN116570404 B CN 116570404B CN 202310855564 A CN202310855564 A CN 202310855564A CN 116570404 B CN116570404 B CN 116570404B
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic 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 provides a valve support and a prosthetic heart valve prosthesis, which relate to the technical field of medical equipment, wherein a support main body and side wings can be elastically folded so as to be conveniently conveyed to a specified position along a blood vessel; the stent body is of a net-shaped structure formed by a plurality of unit grids, the stent body can prop open an annulus in a spread state, artificial heart valve leaves arranged on the stent body are spread, and two ends of the artificial heart valve leaves penetrate through to form an inlet end and an outlet end for blood to flow; the outer diameter of the side wings in the unfolding state is larger than that of the support main body, the side wings obliquely protrude towards the inlet end, the inlet end is at one side of the ventricle, and the side wings are used for limiting the whole valve support, so that the valve support is prevented from moving towards the ventricle, and the possibility that the valve support falls into the ventricle is reduced; the side wings can be propped against the native valve leaflets in the unfolded state, so that the height of the native valve leaflets is reduced, the coronary artery is exposed to the outside, the coronary artery is prevented from being blocked by the opened native valve leaflets, and the probability of blocking the coronary artery by the native valve leaflets is reduced.
Description
Technical Field
The invention relates to the technical field of medical appliances, and further relates to a valve bracket. The invention further relates to a prosthetic heart valve prosthesis.
Background
The heart valve grows between the atrium and the ventricle and between the ventricle and the aorta to play a role of a one-way valve, ensure the unidirectional movement of blood flow, prevent the backflow of blood, play an important role in ensuring the normal function of the heart, and is divided into an aortic valve, a pulmonary valve, a mitral valve and a tricuspid valve. If the valve becomes too narrow and hardens (stenosis) or fails to close completely (regurgitation), normal blood flow is disturbed.
Heart valve disease is mainly due to abnormal heart valves and their accessory structures caused by inflammation, ischemic necrosis, degenerative changes, myxomatosis, congenital developmental deformity, rheumatic diseases, wounds, and the like. Aortic stenosis is progressive and once a patient develops symptoms such as reduced activity, asthma, etc., more severe symptoms such as syncope, angina pectoris, or even sudden death will occur if left untreated.
The aortic valve minimally invasive replacement operation only needs to open a small opening in one blood vessel (such as thigh) of a patient, extend the catheter from the small opening to a proper position of the heart, and then fix the interventional valve at the original valve position after releasing, thereby achieving the purpose of replacing the original valve function. The interventional valve is equivalent to a large bracket + biological valve, the large bracket mainly plays a role in fixing and supporting, and the biological valve is sewed on the large bracket and is used for controlling the blood flow in and out.
In recent years, various transcatheter aortic valve products have been marketed at home and abroad, including: the product of the Edwardsies' SAPIEN series, the Corevalve series of Medun force, etc., are domestic: the Venus series of the open medical treatment, the Taurus series of the Peijia medical treatment, the Vitaflow series of the minimally invasive heart, and the like. However, the native structure of the aortic valve area of the human body is complex, the left and right coronary openings (coronary openings) are arranged above the valve leaflets, and the left ventricular septum conduction bundle branch is arranged below the valve leaflets, and after the existing artificial aortic valve product is implanted, if the valve position is not good, the heart coronary openings are blocked, so that acute myocardial infarction is caused, and therefore, the coronary stent needs to be implanted; if the valve is not well fixed, the valve can gradually slide into the left ventricle, thereby causing atrioventricular conduction block and needing to implant a permanent cardiac pacemaker; or up to the ascending aorta, causing blockage of the ascending aorta and its corresponding large vessel bifurcation, which still plagues clinical professionals, and also presents higher surgical risk and surgical costs to the patient. The main reason for the blockage of the coronary orifice is that the native valve leaflets are pushed by the prosthetic heart valve prosthesis to the aortic valve Dou Bianyuan, which can block the coronary openings.
It is a technical problem that needs to be solved at present for a person skilled in the art how to reduce the blockage probability of the coronary artery opening and prevent the stent from falling into the ventricle.
Disclosure of Invention
The invention aims to provide a valve support and a prosthetic heart valve prosthesis, which can prevent coronary artery blockage and prevent the support from sliding to a left ventricle and prevent the prosthesis from channeling into an ascending aorta after the prosthetic heart valve prosthesis is implanted into a lesion valve part, such as an aortic valve, thereby improving the success rate of operation and reducing the risk and cost of operation, and the specific scheme is as follows:
the valve support comprises a support main body and at least two side wings which are fixedly connected relatively, wherein the support main body and the side wings can be folded, the support main body and the side wings in the folded state are respectively contracted radially, and the radial dimension of the unfolded state of the support main body is larger than that of the folded state; the side wings are connected to the bracket main body;
the bracket main body is of a net-shaped structure formed by a plurality of meshes, and two ends of the bracket main body are communicated to form an inlet end and an outlet end; the stent body is capable of mounting artificial heart valve leaflets; the stent body is capable of expanding an annulus in an expanded state;
the radial dimension of the outer salient point of the side wing in the unfolding state is larger than that of the bracket main body, and the side wing protrudes obliquely towards the inlet end; the wings are capable of pressing against the native leaflets in the deployed state, thereby reducing the height of the native leaflets, preventing the expanded native leaflets from occluding the coronary ostium, and preventing the valve stent from shifting toward the ventricular direction.
Optionally, the number of flank sets up three, flank circumference equidistance distribute in the periphery of support main part, every flank corresponds a native valve leaf respectively.
Optionally, the outlet end of the stent body is provided with a large mesh, the size of the large mesh is larger than the sizes of other meshes on the stent body, and the large mesh can avoid the coronary artery.
Optionally, the size of the macro-mesh is larger than the size of the side flaps, so that in a folded state the side flaps can be folded into the macro-mesh.
Optionally, a side of the macro-mesh near the outlet end is not closed, and an edge of the macro-mesh is used for fixing the artificial heart valve leaflet.
Optionally, an outer Peng Gan capable of being folded is fixedly arranged on the bracket main body, the radial dimension of an outer salient point of the outer Peng Gan in the unfolded state is larger than that of the bracket main body, and the outer Peng Gan protrudes obliquely towards the outlet end;
the outer Peng Gan can be pressed against the ascending aorta near the juncture of the aortic valve sinus to prevent the valve holder from shifting toward the ascending aorta.
Optionally, the outer edges of the flanks and/or the outer peng rod are smooth arcuate curves;
and/or the outer convex points of the side wings are provided with width-increasing areas, and the side wings are propped against the native valve leaflets through the width-increasing areas;
and/or, the outer convex point of the outer Peng Gan is provided with a width-increasing region, and the outer Peng Gan is pressed near the junction of the ascending aorta and the aortic valve sinus through the width-increasing region.
Optionally, the outer Peng Gan corresponds to the side wings one by one, and two ends of the outer Peng Gan and two ends of the side wings are respectively fixed on different support rods arranged on the support main body.
Optionally, the outer Peng Gan is a closed ring structure with ends fixed on the same bracket rod of the bracket main body; and there is a connection point between two adjacent out-expansion rods.
Optionally, the edge of the side wing is connected with the bracket main body through a side wing supporting rod.
Optionally, the side wings are provided with reinforcing grids for improving the strength of the side wings.
And/or the outer peng rod is provided with a reinforcing grid for improving the strength of the outer Peng Gan.
Optionally, the height h1 of the bracket main body is between 19 and 30mm, and the distance h2 between the bottom of the macro-mesh and the inlet end of the bracket main body is between 4 and 10 mm;
and/or the diameter of the inlet end of the bracket main body is between 19 and 32 mm;
and/or, the expansion angle of the side wings ranges from 18 degrees to 60 degrees;
and/or the horizontal distance between the outer salient points of the side wings and the outer side of the bottom of the bracket main body is 4-19mm;
and/or the length of the side wings is 12-22mm.
Optionally, the total height h3 of the stent body and the outer Peng Gan is between 31-50 mm;
and/or the Peng Qi angle of the outer Peng Gan is from 5 to 70 degrees;
and/or the length of the outer expansion rod is 5-30mm.
The invention also provides a prosthetic heart valve prosthesis comprising the valve stent of any one of the above, wherein the valve stent is provided with prosthetic heart valve leaflets;
the artificial heart valve leaflet is a biological tissue material valve or an artificial synthetic polymer material valve;
and/or, the valve stent is nickel-titanium memory alloy.
The invention provides a valve support, wherein a support main body and side wings are relatively and fixedly connected, both the support main body and the side wings can be elastically folded, and the support main body and the side wings are respectively contracted radially in a folded state so as to be conveniently conveyed to a designated position along a blood vessel; the stent body is of a net-shaped structure formed by a plurality of unit grids, the stent body can prop open an annulus in a spread state, artificial heart valve leaves arranged on the stent body are spread, and two ends of the artificial heart valve leaves penetrate through to form an inlet end and an outlet end for blood to flow; the radial dimension of the outer salient point of the side wing in the unfolding state is larger than that of the support main body, the side wing protrudes obliquely towards the inlet end, the inlet end is at one side of the ventricle, and the side wing is used for limiting the whole valve support, so that the valve support is prevented from moving towards the ventricle, and the possibility that the valve support falls into the ventricle is reduced; the side wings can be propped against the native valve leaflets in the unfolded state, so that the height of the native valve leaflets is reduced, the coronary artery is exposed to the outside, the coronary artery is prevented from being blocked by the opened native valve leaflets, and the probability of blocking the coronary artery by the native valve leaflets is reduced.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic front view of a valve stent according to a first embodiment of the present invention in a deployed state;
FIG. 2 is an enlarged view of a portion of the dashed box of FIG. 1;
FIG. 3 is a schematic top view of a valve stent according to a first embodiment of the present invention in a deployed state;
FIG. 4 is a schematic front view showing the use state of a first embodiment of a valve stent according to the present invention;
FIG. 5 is a schematic top view illustrating a first embodiment of a valve stent according to the present invention in use;
FIG. 6 is a schematic front view of a valve stent according to a first embodiment of the present invention folded;
FIG. 7 is a schematic front view of a valve stent according to a second embodiment of the present invention in a deployed state;
FIG. 8 is a schematic top view of a second embodiment of a valve stent according to the present invention in a deployed state;
FIG. 9 is a schematic view of a first construction of a side flap provided with a reinforcing mesh;
FIG. 10-1 is a schematic front view of a second construction of a wing provided with a wing support bar;
FIG. 10-2 is a schematic side view of a second construction of a wing provided with a wing support bar;
fig. 11 is a schematic structural view of an outer Peng Gan provided with reinforcing mesh;
FIG. 12 is a schematic front view of an embodiment of a prosthetic heart valve prosthesis according to the present invention in a deployed state;
fig. 13 is a schematic top view of an embodiment of a prosthetic heart valve prosthesis according to the present invention in a deployed state.
The drawings include:
the heart valve comprises a bracket main body 1, a large mesh 11, a bracket rod 12, a side wing supporting rod 13, a side wing 2, an outer Peng Gan 3, an artificial heart valve leaflet 4 and a reinforcing grid 5;
native valve I, annulus II, valve Dou, ascending aorta IV, and coronary ostia V.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The present invention will be further described in detail below with reference to the drawings and detailed description for the purpose of enabling those skilled in the art to better understand the aspects of the present invention.
After the artificial heart valve is implanted to the position of the diseased aortic valve, the left and right coronary artery V is easily blocked after the native valve I is pushed by the bracket to be close to the aortic valve Dou; in addition, if the artificial heart valve prosthesis is fixed by only depending on the radial force between the stent main body and the valve annulus II or the acting force of the grid on the stent main body and the primary valve leaflet I, the stent is easy to slide to the ventricle, thereby causing conduction block and needing to implant a permanent cardiac pacemaker; in addition, the existing on-market artificial heart valve prosthesis cannot obtain better results in the aspect of treating aortic valve regurgitation, the problem that the valve is pushed to the coronary artery V to cause blockage exists, and the problems that the stent cannot act with a diseased valve, the stent is unstable in anchoring, easy to move and the like easily occur.
As shown in fig. 1 to 3, the invention provides a valve stent, which comprises a stent main body 1, at least two side wings 2 and other structures, wherein the stent main body 1 and the side wings 2 are relatively and fixedly connected, and the upper edges of the side wings 2 are connected with the stent main body 1 in combination with the view shown in fig. 1; the support main body 1 and the side wings 2 are elastic, the support main body 1 and the side wings 2 can be elastically folded, the side wings 2 are close to the support main body 1 during folding, the support main body 1 is folded, the support main body 1 in a folded state is radially contracted, the side wings 2 are radially contracted, and the radial size of the whole valve support is reduced during folding. The radial dimension of the stent body 1 in the unfolded state is larger than that of the stent body in the folded state; in some embodiments, the connection of the side wings 2 is unfolded synchronously with the stent body 1 as the stent body transitions from the collapsed state to the expanded state; the invention also encompasses cases where the side wings 2 are not deployed synchronously with the stent body 1, for example, hereinafter referred to as stent struts 12, the stent struts 12 in the deployed state may be radially retracted or extended, in which case the connection is located at the retraction or extension.
The bracket main body 1 is a net cylindrical structure formed by a plurality of unit grids, when unfolded, a cylindrical structure is formed, the structure forming the cylindrical surface is the unit grids connected with each other, and when folded, the size of the unit grids is reduced, so that a space is reserved for folding. The stent body 1 has both ends penetrating to form an inlet end and an outlet end, the inlet end and the outlet end being provided for blood to flow, and when the stent body 1 is mounted in a blood vessel, the outer surface of the stent body 1 fully or partially contacts the inner wall of the blood vessel, and blood flows from the inlet end to the outlet end. As shown in fig. 1 and 4, the lower end of the holder body 1 is an inlet end, the upper end is an outlet end, and the flow direction of blood is shown by an arrow in fig. 4.
The artificial heart valve 4 can be installed to the support main part 1, and artificial heart valve 4 connects in the inboard of support main part 1, and artificial heart valve 4 provides the support by support main part 1, and support main part 1 is fixed in the blood vessel, and artificial heart valve 4 is used for substituting the function that primary valve I played unidirectional current, only allows blood to flow from the entry end to the exit end, and blood can't reverse flow. Such as an aortic valve located between the aorta and the ventricle, the artificial heart valve leaflet 4 is adapted to open when blood flows from the ventricle to the aorta and to close when blood flows from the aorta to the ventricle.
The stent body 1 can open the valve annulus in the expanded state, and the stent body 1 has a circular or elliptical cross section in the expanded state, and in one embodiment, the stent body 1 has a cylindrical or elliptical cylindrical shape, preferably a cylindrical or nearly cylindrical shape, and in another embodiment, the stent body may have a structure with different radial dimensions, such as an upper or lower radially contracted shape. When the bracket main body 1 is completely unfolded, the outer surface of the bracket main body 1 is in contact with the inner wall of the vascular tissue, the radial dimension of the outer wall of the bracket main body 1 is slightly larger than the inner diameter dimension of the inner wall of the vascular tissue, the bracket main body 1 and the inner wall of the vascular tissue form interference fit, the bracket main body 1 radially extrudes the inner wall of the vascular tissue to a certain extent, and the bracket main body 1 is positioned by utilizing the acting force between the bracket main body 1 and the inner wall of the vascular tissue, so that the probability of displacement of the bracket main body 1 in the axial direction is reduced.
The radial dimension of the outer salient point of the side wing 2 in the unfolding state is larger than that of the support main body 1, namely, at least a part of the structure of the side wing 2 protrudes out of the support main body 1 in the unfolding state, the side wing is fixed on the support main body 1, the side wing 2 protrudes obliquely towards the inlet end, namely, an included angle smaller than 90 degrees is formed between the extending direction of the side wing 2 and the inlet end of the axis direction of the support main body 1, and an extending component exists in the direction of the side wing 2 towards the inlet end. The position of the wing 2 with the largest convex radial dimension is the convex point (or called the tail end, the lowest point of the wing 2 is shown in fig. 1), the position of the outer convex point is the position with the largest radial dimension, the position of the outer convex point is closer to the inlet end than the fixed point of the wing 2, and the wing 2 can be pressed against the native valve leaflet I in the unfolded state, so that the height of the native valve leaflet I is reduced, the expanded native valve leaflet is prevented from blocking the coronary orifice, and the valve stent is prevented from moving towards the ventricular direction.
With reference to fig. 4, the lower end of valve II is attached to the ventricle, the inner diameter of valve II is smaller than the inner diameter of valve Dou, and a transition portion of contracted size is formed at the junction of valve II and valve Dou; the inner diameter of the aorta IV is smaller than the inner diameter of the valve Dou, forming a transition of reduced size at the junction of the aorta IV and the valve Dou. The primary valve leaflet I is a valve leaflet which grows on the valve annulus II and is positioned in the valve Dou, the primary valve leaflet I is provided with three valve leaflets, under normal conditions, the primary valve leaflet I plays a role in one-way cut-off, and when the primary valve leaflet I is diseased and can not work normally, the artificial heart valve leaflet 4 replaces the primary valve leaflet I to play a role in one-way cut-off.
With reference to fig. 4 and 5, the coronary artery port v has two coronary artery ports which are respectively grown on the valve sinus iii, the position of the coronary artery port v corresponds to the positions of two of the native valve leaflets i, and if the side wings 2 provided by the present invention are not provided, the native valve leaflets i are spread by the stent body 1, and the height of the upper ends of the native valve leaflets i is higher (closer to the aorta iv), possibly causing the obstruction of the coronary artery port v. In the invention, at least two side wings 2 are arranged, each side wing 2 can correspondingly press down one native valve leaflet I, so that the two native valve leaflets I corresponding to the coronary artery V are pressed down, the height of the native valve leaflet I pressed down by the side wings 2 is lower (the native valve leaflet I is closer to the annulus II), and the native valve leaflet I cannot block the coronary artery V, so that the probability that the coronary artery is blocked by the native valve leaflet is reduced.
Because the side wings 2 are protruded out of the support body 1 in the unfolded state, and the support body 1 expands outwards to squeeze the valve annulus II, the side wings 2 cannot slide into the ventricle below through the valve annulus II, the valve support is prevented from moving towards the ventricle, and the possibility that the valve support falls into the ventricle is reduced.
Based on the scheme, the number of the side wings 2 is preferably three, so that circumferential positioning is facilitated, and more side wings 2 can be arranged; the flank 2 is circumference equidistance and distributes in the periphery of support main part 1, and every flank 2 corresponds a native valve leaf respectively, and the effort that every flank 2 can push down a native valve leaf I promptly makes each angle receive evenly unanimous, can avoid support main part 1 to take place the slope. The side wings 2 can be pressed against the lower wall of the valve sinus III or the valve annulus II, and the support of the lower wall of the valve sinus III or the valve annulus II is used for supporting the support body 1, so that the support body 1 is prevented from moving downwards, and the ventricular wall is prevented from being pressed more.
The outlet end of the stent main body 1 is provided with big meshes 11, the size of the big meshes 11 is larger than other grid sizes on the stent main body 1, and the big meshes 11 can be used for avoiding the coronary artery port V. Referring to fig. 1 and 4, the bracket main body 1 is provided with a plurality of unit grids with uniform sizes, and the shapes of the unit grids are not limited, and the unit grids can be diamond grids or regular hexagon grids; the big mesh 11 is arranged at the outlet end of the bracket main body 1, which is equivalent to cutting off a part of the mesh wall surface at the outlet end of the bracket main body 1, and a part of the unit meshes are missing on the bracket main body 1 to form the big mesh 11, and the edge of the big mesh 11 is formed by a plurality of unit mesh edges which are arranged. Because the large mesh 11 part has no solid structure, the blockage of the coronary artery opening V can be avoided, the subsequent coronary artery operation is also facilitated, an avoidance space is provided for the instrument of the coronary artery operation, and the instrument of the coronary artery operation is facilitated to extend into the coronary artery opening V.
The shape and the size of the side wings 2 and the big meshes 11 can ensure that the side wings 2 are smoothly folded in the sleeve in the folding process and the folding state, and can be smoothly pulled out from the sleeve. Further, the size of the macro-mesh 11 is larger than that of the side wings 2 in the invention, so that the side wings 2 can be folded into the macro-mesh 11 in a folded state, the side wings 2 are folded in the sleeve or are separated from the sleeve without interference, the valve stent is required to be put in the sleeve in the folded state in operation, the valve stent is transferred to a proper position by the sleeve, and then the sleeve is pulled out to release the valve stent. The folded side wings 2 include two kinds, the side wings 2 being flush or lower than the stand main body 1: one is that the outer surface of the side flap 2 when folded is flush with the outer surface of the main body 1 of the stand, and the other is that the outer surface radial dimension of the side flap 2 when folded is smaller than the outer surface radial dimension of the main body 1 of the stand. With reference to fig. 6, since the profile of the macro-mesh 11 is larger than the profile of the side wings 2, when the side wings 2 are folded and compressed, the side wings 2 can completely enter the range of the macro-mesh 11, and since the macro-mesh 11 has no solid structure, the macro-mesh 11 forms an avoidance space for the side wings 2, the side wings 2 can completely retract into the stent body 1, when the side wings 2 are folded and retracted, the side wings 2 can be flush with the surface of the stent body 1, the outer diameter of the stent body 1 is not increased, and the delivery of the stent to the lesion position of the native valve through a catheter is not affected.
The side of the big mesh 11 close to the outlet end is not closed, the edge of the big mesh 11 is of an arc-shaped structure which is not closed, and the edge of the big mesh 11 is used for fixing the artificial heart valve leaflet 4. The artificial heart valve 4 is correspondingly arranged at the big mesh 13, the upper edge of the artificial heart valve 4 does not exceed the uppermost end of the support rod 12 of the big mesh 11, the lower edge of the artificial heart valve 4 can be slightly higher or lower than the lowest end of the big mesh 11, and the side edge of the artificial heart valve 4 is mostly positioned in the edge of the big mesh 13.
The number of the artificial heart valve leaflets 4 is 3, but the number of the macro-mesh 11 may be not 3, but may be 2 or more than 3, and at this time, the macro-mesh 11 does not correspond to the artificial heart valve leaflets 4; when the number of the artificial heart valve leaflets 4 is 2, the side edges of the artificial heart valve leaflets 4 are fixed on the grid frame of the unit grid, and when the number of the artificial heart valve leaflets is other, the shape and the structure of the unit grid can be adjusted, and the side edges of the artificial heart valve leaflets 4 are fixed on the grid frame of the unit grid.
The positions of the big meshes 11 close to the outlet ends can also be connected with each other through connecting rods, the outlet ends of the big meshes 11 are closed by the connecting rods, the rigidity of the big meshes 11 is improved, but the big meshes 11 still form avoidance for the hollowed-out areas, and the structure is also included in the protection scope of the invention. The connecting rods may also serve as connection points for the wings 2, the wings 2 being supported by the connecting rods.
As a preferred scheme, the valve stent is of a nickel-titanium memory alloy structure, namely, a stent main body and side wings forming the valve stent are of a nickel-titanium memory alloy structure, and the valve stent comprises an outer Peng Gan 3 which is described later and is of a nickel-titanium memory alloy structure.
If the prosthetic heart valve prosthesis is secured by means of radial forces between the stent body and the annulus ii or by co-acting the mesh on the stent body with the forces of the native leaflets i, in some cases stent migration up into the ascending aorta will occur, causing problems with bifurcation blockage of the ascending aorta and its corresponding large vessels. Therefore, on the basis of any one of the above technical schemes and the combination thereof, the outer part Peng Gan 3 which can be elastically folded is fixedly arranged on the bracket main body 1, the radial dimension of the outer convex point of the outer part Peng Gan in the unfolded state is larger than that of the bracket main body 1, the outer part Peng Gan 3 is obliquely protruded towards the outlet end, namely, the extending direction of the outer expansion rod 3 forms an included angle smaller than 90 degrees with the outlet end in the axial direction of the bracket main body 1, and the outer part Peng Gan has an extending component towards the outlet end. The outer Peng Gan has the greatest outward radial dimension at the point of outward bulge (or tip, the highest point of the outer wand 3 shown in fig. 1) which is located closer to the outlet end than the fixed point of the outer wand 3. The outer expansion rod 3 can be pressed near the junction of the ascending aorta IV and the aortic valve sinus, so that the valve stent is prevented from moving towards the ascending aorta IV. The outer expansion rod 3 is used for pressing the junction between the ascending aorta IV and the aortic valve sinus III, but is not completely positioned at the ascending aorta IV, and is of a convergent structure with a tapered inner diameter, and is tapered from the valve Dou to the ascending aorta IV, so that the position of the whole valve support is limited, and the whole valve support is prevented from moving towards the ascending aorta IV. The valve stent provided by the invention is provided with the side wings 2 and the outward expansion rod 3, so that various problems can be solved: the problem that the primary valve leaflet I blocks the coronary artery V is solved, and the problem of upward movement and downward movement of the valve stent is solved (only the side wings 2 are arranged, so that the problem of downward movement of the valve stent can be solved, and the upward movement can be better avoided by arranging the outward expansion rod 3); meanwhile, the valve stent can be implanted through the strand, has small wound, is simple to release and operate, and can effectively improve the operation time and the postoperative recovery time.
In connection with fig. 1, the present invention provides a specific arrangement of the valve stent (in the following description, if reference is made to the structural shapes of the side wings 2 and the macro-mesh 11 and the added features thereof, those skilled in the art will understand that the corresponding structural shapes of the side wings 2 and the macro-mesh 11 and the added features thereof can also be applied to the embodiment of the valve stent without the outer expansion rod 3), the outer edges of the side wings 2 and the outer edges of the outer expansion rod 3 are both smooth arc curves, and the side wings 2 and the outer Peng Gan 3 are both smooth arc curves or obtuse angles, preferably smooth arc curves, so as to avoid sharp corners and avoid stress concentration and damage to the side walls and the valve annulus.
The side wings 2 and the outer Peng Gan 3 are respectively in a V-shaped or U-shaped shape, and the side wings 2 or the outer expansion rod 3 are formed by a solid arc-shaped structure.
In some embodiments, the outer convex points of the side wings 2 and/or the outer convex points of the outer expansion rods 3 are provided with areas with increased width, namely, the side wings 2 and the outer Peng Gan are in unequal width shapes with large width near the outer convex points and small width at other positions; the outer salient points of the side wings 2 and the outer convex points of the outer expansion rods 3 are respectively contacted with the inner wall of the vascular tissue through the increased width regions, the pressure on the inner wall of the vascular tissue can be reduced through the larger width, the contact area of the side wings 2 and the primary valve blades I is increased, and the damage to the primary valve blades I is reduced. It should be noted that the side flaps 2 and the outer portions Peng Gan 3 may be of an equal width structure having a larger overall width.
The support body 1 is provided with the support rods 12, the support rods 12 can be formed by support bodies between two adjacent big meshes 11, the width of the support rods 12 is set according to the size shape of the big meshes, and preferably, the width of the support rods 12 is gradually reduced along the outlet direction of the support body 1. Preferably, the uppermost ends of the support rods have no grid structure. As shown in fig. 2. Preferably, the side wings 2 are attached to the upper ends of the support rods. Preferably, the outer expansion rod 3 is connected to the uppermost end of the bracket rod. As an embodiment, the bracket rod 12 is gradually retracted or extended in radial dimension along the direction of the outlet of the bracket main body 1, or may be provided with a structure such as concave in the middle, convex on the upper and lower sides, and the like, as required.
In some embodiments, the outer portions Peng Gan 3 are in one-to-one correspondence with the side wings 2, and referring to fig. 1 and 3, the outer portions Peng Gan are respectively arranged in three with the side wings 2, and the circumferential positions of the outer portions Peng Gan are mutually corresponding with the circumferential positions of the side wings 2. The two ends of the outer expansion rod 3 and the two ends of the side wings 2 are respectively fixed on different support rods 12 arranged on the support main body 1, as shown in fig. 1 and 2, the outer Peng Gan and the side wings 2 are of non-closed arc structures, the two ends of the outer expansion rod 3 are fixed points, and the two ends are respectively fixed on the two different support rods 12; the two ends of the side wing 2 are fixed points, and the two ends are respectively fixed on two different support rods 12. The width of the bracket bar 12 is greater than the width of other positions of the bracket body 1, that is, the width of the bracket bar 12 is greater than the width of the frame constituting the unit mesh on the bracket body 1, thereby improving the connection support strength. The preferred construction of the side wings 2 and outer expansion rods 3 attached to the support rods 12 allows for a more compact construction, and the side wings 2 and outer Peng Gan 3 may be attached to the edges of, for example, a large mesh 11.
In other embodiments, referring to fig. 7 and 8, the outer portion Peng Gan 3 is a closed ring structure fixed on the same support rod 12 of the support body 1 from end to end; in some preferred embodiments, the ring structure may be provided with reinforcing mesh to increase the strength of the out-peng rod 3. The connecting points exist between two adjacent outward expansion rods 3, and the structural strength of the outward expansion rods 3 is increased by fixedly connecting the adjacent outward expansion rods 3 with each other; in this embodiment, the bracket bar 12 has a width larger than other positions of the bracket body 1, thereby improving the supporting strength and reducing the deformation amplitude.
It should be noted that the outer expansion rod 3 may take different structural forms, and has the main function of propping against the position between the valve Dou and the ascending aorta iv, limiting the position of the valve support, counteracting the pressure generated by the blood flow from the ventricle to the ascending aorta iv on the artificial heart valve leaflet 4, and preventing the valve support from moving towards the aorta.
In other embodiments, with reference to fig. 10, the side wings 2 are connected to the bracket body 1 by a plurality of side wing support bars 13. The connection points at the two ends of the flank supporting rods 13 are respectively positioned on the edge frame of the flank 2 or the grid frame on the flank 2 and the grid frame near the edge frame of the big mesh 11 or the big mesh 11, and are preferably arranged on the edge frame of the flank 2 and the edge frame of the big mesh 11; the connection points at the two ends of the side wing supporting rods 13 are arranged at the edge frame of the side wing 2 or the edge frame of the big mesh 11, so that the side wing 2 can be folded, the pressing of the side wing 2 to the original valve leaflet is not affected during unfolding, and meanwhile, the side wing supporting rods 13 can be folded and unfolded normally along with folding or unfolding of the side wing 2, and the side wing supporting rods are not broken or fall off from the side wing 2 or the big mesh 11. As a preferred embodiment, the position of the connection point of the edge frame of the side wing 2 is located at the middle position of the edge extending direction of the side wing 2, and at the same time, the position of the connection point between the side wing support rod 13 and the edge frame of the big mesh 11 deviates from the position of the connection point on the edge frame of the side wing 2 corresponding to the edge frame of the big mesh 11 in the folded state, so that the side wing support rod 13 is prevented from being stressed excessively when the side wing 2 is folded, and in this form, the connection point of the side wing 2 is not arranged at the part of the side wing 2 which presses against the native valve leaflet. The side wing support bar 13 may be a single bar, as illustrated in fig. 10-1 and 10-2, but the side wing support bar 13 may be a plurality of bars. The wings in the embodiment with the wing support bar require more force to be applied when they are folded than in the embodiment without the wing support bar. Through the effect of flank bracing piece 13, make flank 2 under the expansion state, receive flank bracing piece 13's support or tensile effect, make and form more tie points between flank 2 and the support main part 1, shape structure is more firm, difficult deformation. The side flap support bar 13 is elastically deformed when the side flap 2 is compressed and folded. The material of the side wing support bar 13 is the same as that of the side wing 2.
Referring to fig. 9, 10 and 11, the side wings 2 and/or the outer Peng Gan 3 in the present invention are provided with reinforcing grids 5, wherein the reinforcing grids 5 are formed by splicing a plurality of diamond-shaped grid structures, and the reinforcing grids 5 are used for improving the strength of the side wings 2 or the outer expansion rods 3.
In connection with fig. 12, it is reported in the literature that the aortic valve Dou is generally between 15 and 20mm in height, and that, in order to ensure that the stent can be completely secured between the aortic annulus ii and the ascending aorta iv, it is preferable that in the expanded state (whether the stent rod 12 is expanded, contracted, or not) the stent body 1 is cylindrical or not), the following relationship is satisfied for each structural dimension:
the height h1 of the bracket main body 1 (the vertical distance between the uppermost end of the bracket rod 12 and the bottom of the bracket main body 1) ranges from 19mm to 30 mm; the distance h2 between the bottom of the macro-mesh 11 and the inlet end of the bracket main body 1 is between 4 and 10mm, the total height h3 between the bracket main body 1 and the outer Peng Gan 3 is between 31 and 50mm when the bracket main body is provided with an outer expansion rod structure, and meanwhile, the side wings and the outer Peng Gan are obliquely protruded.
According to literature reports, the diameter of the aortic valve Dou of the human body is generally between 18 and 30mm, and the diameter d of the inlet end of the stent body 1 is designed between 19 and 32mm in order to ensure that the stent body 1 is tightly fixed with the valve annulus II.
According to literature reports, the maximum diameter of the aortic valve Dou can be between 30-45mm, and the expansion angle α of the wings 2 can be set in the range of 18-60 degrees, preferably in the range of 20-45 degrees.
The angle of expansion β of the outer expansion rod 3 is in the range of 5-70 degrees, more preferably, peng Qi degrees is in the range of 15-45 degrees.
The lateral flanks 2 are preferably located at a horizontal distance of 4-19mm, see the distance L3 in fig. 4, from the outer side of the bottom of the holder body 1, preferably in the range of 4.5-15mm. The above dimension is defined for the dimension when the bracket body 1 is of a cylindrical structure, and for the bracket body 1 is of a non-cylindrical structure, as the horizontal distance of the outer convex point of the side wing 2 from the position of the maximum radial dimension of the bottom of the bracket body 1.
As an embodiment, when the stent body 1 is cylindrical, the stent rod is disposed along the extending direction of the stent body 1 without being radially contracted or expanded. At this time, the side wing 2 is in a state of being expanded and lifted, namely, the side wing 2 rotates axially along the connecting line of the side wing 2 on the bracket rod, and as shown in fig. 1, 2 and 12, the expanding angle α of the side wing 2 is an angle formed by the connecting line of the midpoint of the rotation axis formed by the salient point (the lowest point of the side wing 2 in fig. 1) outside the side wing 2 and the connecting point of the two corresponding bracket rods 12 and the axis of the bracket main body 1; the length of the flank 2, i.e. the distance between the lowest point of the flank 2 and the midpoint of the rotation axis formed by the connection point of the corresponding two carrier bars 12.
As shown in fig. 1, 2 and 12, the expansion angle α of the side wing 2 is the angle formed by the midpoint of the connecting line between the convex point (the lowest point of the side wing 2 in fig. 1) outside the side wing 2 and the corresponding two bracket rods 12 and the axis of the bracket main body 1; the length of the side flap 2, i.e. the distance between the lowest point of the side flap 2 and the midpoint of the line segment between the connection points of the side flaps 2 corresponding to the two bracket bars 12.
Here, the preferred embodiment is a structure in which the bracket bar connection is the uppermost end of the bracket bar 12, and is also the connection point of the side wing 2 and the bracket bar 12. When the outer portion Peng Gan 3 is provided in the structure of the bracket, it is also the connection point between the outer portion Peng Gan 3 and the bracket bar 12.
The L1 and the expansion angle α thus set enable the distal end of the lateral wing 2 to be pressed as far as possible over the native leaflet i or the annulus ii, while enabling the height position of the stent rod 12 to be within a predetermined range, for example, a range relative to the height position over the annulus ii.
In combination with fig. 1 and 12, the expansion angle β of the outer expansion rod 3, that is, the angle formed by the connection line between the top end of the outer expansion rod Peng Gan and the midpoint of the line segments of the two corresponding bracket rods 12 and the axis of the bracket main body 1, is set to be 5-70 degrees, preferably 15-45 degrees, and the vertical height of the top end of the outer expansion rod Peng Gan from the connection part of the bracket rods 12 is (h 3-h 1) in the range of 1-15mm; the length L2 of the out-expansion rod 3, i.e. the distance between the top end of the out-expansion rod Peng Gan and the midpoint of the line segment between the connection points of the out-side Peng Gan of the corresponding two support rods 12, is in the range of 5-30mm, preferably in the range of 7-20mm.
In other non-preferred embodiments, for example, when the connection point between the side wing 2 and the support rod 12 or the macro-mesh 11 is provided on the other edge of the macro-mesh 11, the expansion angle α of the side wing 2 and the expansion rod 3, respectively, and the length L thereof may be within the above-mentioned parameter ranges.
It should be noted that, in connection with fig. 3 and 5, in this embodiment, the outer diameter of the side wing 2 in the unfolded state is larger than the outer diameter of the outer expansion rod 3, but the present invention is not limited thereto, and needs to be matched with the size of the corresponding position of the inner wall of the blood vessel.
The invention also provides a prosthetic heart valve prosthesis, which comprises the valve bracket, wherein the prosthetic heart valve leaflet 4 is arranged on the valve bracket; the artificial heart valve leaflet 4 is a biological tissue material valve or an artificial synthetic polymer material valve. The artificial heart valve prosthesis is propped against the upper part of the valve annulus II through the side wings 2, so that the position of the artificial heart valve prosthesis is limited, namely, the side wings 2 act on the primary valve leaflet I and extend and prop against the space formed by the valve sinus III, and when blood flows back from the ascending aorta IV to the ventricle, the artificial heart valve leaflet 4 is closed; the side wings 2 can be propped against the upper part of the valve annulus II under the side wings 2 in the unfolding state to counteract the pressure generated by the backflow of blood flow to the heart chamber on the artificial heart valve leaves 4, so that the artificial heart valve prosthesis is prevented from sliding to the heart chamber to generate conduction block, and the stable implantation of the heart valve prosthesis is realized; the outer expansion rod 3 is used for pressing the junction between the ascending aorta IV and the aortic valve sinus III, but not all the outer expansion rod is positioned at the junction between the ascending aorta IV and the aortic valve sinus III, so that the artificial heart valve prosthesis is prevented from upwards moving, namely, when blood flows from a ventricle to the ascending aorta IV, the artificial heart valve leaflet 4 is opened, the outer expansion rod 3 is pressed at the junction between the ascending aorta 8 and the aortic valve sinus 7, the pressure generated by the blood flowing into the ascending aorta IV on the artificial heart valve leaflet 4 is counteracted, and the artificial heart valve prosthesis is prevented from upwards moving.
Specifically, the valve stent is made of memory alloy, preferably nickel-titanium memory alloy, and preferably adopts a memory alloy structure; biological tissue material valves adopted by the artificial heart valve 4 comprise pig pericardium and cow pericardium; the artificial synthetic polymer material valve adopted by the artificial heart valve leaflet 4 comprises polyether polyurethane, polycarbonate polyurethane, polysiloxane polyurea polyurethane, polysiloxane type polyoxime polyurethane, polytetrafluoroethylene, polystyrene elastomer and polyisobutylene elastomer. The valve stent adopts nickel-titanium memory alloy, the nickel-titanium memory alloy can automatically recover to an unfolding state, in the operation process, the valve stent is folded and compressed into the sleeve, the folding state is kept, after the valve stent moves to a designated position along with the sleeve, the sleeve is retracted to release the valve stent, and the valve stent automatically unfolds and expands under the elastic action of the valve stent and is propped against the corresponding position in a blood vessel. As another embodiment, the stent body of the valve stent is chrome cobalt alloy and the wings and outer Peng Gan are nickel titanium memory alloy. The valve stent is folded and compressed onto the balloon catheter and is positioned in the sleeve, the folded state is kept, after the valve stent moves to a designated position along with the balloon catheter, the sleeve is retracted, the side wings and the outer Peng Gan are opened, the balloon expands to open the stent main body and is pressed to the corresponding position in the blood vessel.
In summary, the artificial heart valve prosthesis and the valve stent provided by the invention are provided with the big mesh 11, the side wings 2 and the outer Peng Gan, the big mesh 11 can avoid blocking the coronary artery V, and the subsequent coronary artery operation is also facilitated; the structure of the side wings 2 can reduce the height of the primary valve leaflet I and fix the position of the heart valve prosthesis, and when the valve stent is in a unfolded state, the side wings 2 face outwards Peng Qi to prop against the primary valve leaflet I, so that the height of the primary valve leaflet I can be reduced, and the risk that the coronary artery port V of the coronary artery is blocked by the primary valve leaflet I is reduced; meanwhile, the side wings 2 can be just propped against the upper part of the valve ring II, so that the prosthetic heart valve prosthesis is prevented from sliding towards the ventricle, the risk of atrioventricular block is reduced, and the risk of implantation of a permanent cardiac pacemaker is reduced. In addition, the outward expansion rod 3 can be pressed near the ascending aorta IV and the aortic valve Dou, but not be completely positioned at the ascending aorta IV, and can also prevent the stent from channeling upwards to the ascending aorta IV. The side wings 2 of the invention can be completely compressed in the big mesh 11 structure of the stent main body 1, the compression volume of the stent 1 is not increased, the invention is suitable for various catheter implantation techniques such as transfemoral implantation, and the like, has small wound and simple operation.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (10)
1. The valve stent is characterized by comprising a stent main body (1) and at least two side wings (2) which are fixedly connected relatively, wherein the stent main body (1) and the side wings (2) can be folded, the stent main body (1) and the side wings (2) in a folded state are respectively contracted radially, and the radial dimension of the stent main body (1) in an unfolded state is larger than that of the stent main body in a folded state; the side wings (2) are connected to the bracket main body (1);
the bracket main body (1) is of a net-shaped structure formed by a plurality of unit grids, and two ends of the bracket main body are communicated to form an inlet end and an outlet end; the bracket main body (1) can be provided with artificial heart valve leaflets (4); the stent body (1) is capable of expanding an annulus in an expanded state;
the radial dimension of the outer salient point of the side wing (2) in the unfolded state is larger than that of the bracket main body (1), and the side wing (2) protrudes obliquely towards the inlet end; the side wings (2) are used for pressing the lower surfaces of the primary valve leaflets in an unfolding state, so that the heights of the primary valve leaflets are reduced, the expanded primary valve leaflets are prevented from blocking the coronary artery, and the valve stent is prevented from moving towards the ventricle direction;
the outlet end of the bracket main body (1) is provided with a big mesh (11), the size of the big mesh (11) is larger than the sizes of other unit meshes on the bracket main body (1), the big mesh (11) is used for avoiding the coronary artery, avoiding the blockage of the coronary artery, providing an avoidance space for the instrument of the coronary artery operation, and facilitating the instrument of the coronary artery operation to extend into the coronary artery; the macro-mesh (11) has a size larger than the side wings (2) such that in a folded state the side wings (2) can be folded into the macro-mesh (11);
the number of the side wings (2) is three, the side wings (2) are circumferentially distributed at equal intervals on the periphery of the bracket main body (1), and each side wing (2) corresponds to one primary valve leaf respectively;
an outer Peng Gan (3) which can be folded and furled is fixedly arranged on the support main body (1), the radial dimension of an outer convex point of the outer Peng Gan (3) in the unfolded state is larger than the radial dimension of the support main body (1), and the outer Peng Gan (3) protrudes obliquely towards the outlet end; the outer Peng Gan (3) can be pressed near the junction of the ascending aorta and the aortic valve sinus, so that the valve support is prevented from moving towards the ascending aorta;
the outer Peng Gan (3) corresponds to the side wings (2) one by one, the outer Peng Gan (3) is fixedly connected with two ends of the side wings (2), and two ends of the outer Peng Gan (3) and two ends of the side wings (2) are respectively fixed on different support rods (12) arranged on the support main body (1).
2. Valve holder according to claim 1, characterized in that the side of the macro-mesh (11) near the outlet end is not closed, the edges of the macro-mesh (11) being used for fixation of the artificial heart valve leaflet (4).
3. Valve holder according to claim 1, characterized in that the outer edges of the flanks (2) and/or the outer Peng Gan (3) are smoothly curved;
and/or the outer convex point of the side wing (2) is provided with a width-increasing area, and the side wing (2) is pressed against the primary valve leaflet through the width-increasing area;
and/or, the outer convex point of the outer Peng Gan (3) is provided with a width-increasing area, and the outer Peng Gan (3) is pressed near the junction of the ascending aorta and the aortic valve sinus through the width-increasing area.
4. Valve stent according to claim 1, characterized in that the outer Peng Gan (3) is a closed ring structure fixed end to end on the same stent rod (12) as the stent body (1); and there is a connection point between two adjacent outer Peng Gan (3).
5. Valve holder according to claim 1, characterized in that the edges of the wings (2) are connected to the holder body (1) by wing support bars (13).
6. Valve stent according to claim 1, characterized in that the side wings (2) are provided with reinforcing grids (5), which reinforcing grids (5) serve to increase the strength of the side wings (2).
7. Valve stent according to claim 1, characterized in that the outer Peng Gan (3) is provided with a reinforcement grid (5), the reinforcement grid (5) being used to increase the strength of the outer Peng Gan (3).
8. Valve stent according to claim 1, characterized in that the height h1 of the stent body (1) is between 19-30mm, the spacing h2 of the bottom of the macro-mesh (11) from the inlet end of the stent body (1) is between 4-10 mm;
and/or the diameter of the inlet end of the bracket main body (1) is between 19 and 32 mm;
and/or the expansion angle of the side wing (2) is 18-60 degrees;
and/or the horizontal distance between the outer salient points of the side wings (2) and the outer side of the bottom of the bracket main body (1) is 4-19mm;
and/or the length of the side wing (2) is 12-22mm.
9. Valve stent according to claim 1, characterized in that the total height h3 of the stent body (1) and the outer Peng Gan (3) is between 31-50 mm;
and/or the Peng Qi angle of the outer Peng Gan (3) is 5-70 degrees;
and/or the length of the outer Peng Gan (3) is 5-30mm.
10. A prosthetic heart valve prosthesis, characterized in that it comprises a valve stent according to any one of claims 1 to 9, said valve stent being fitted with prosthetic heart valve leaflets (4);
the artificial heart valve leaflet (4) is a biological tissue material valve or an artificial synthetic polymer material valve;
and/or, the valve stent is nickel-titanium memory alloy.
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| CN202310855564.2A CN116570404B (en) | 2023-07-13 | 2023-07-13 | Valve support and artificial heart valve prosthesis |
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Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116570404A (en) | 2023-08-11 |
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