Valve stent, aortic valve and mitral valve

Abstract

The invention discloses a valve stent, an aortic valve and a mitral valve, and the valve stent comprises a valve stent which is of a latticed annular stent structure formed by cutting a metal tube; the outer frame is of a latticed or semi-latticed annular support structure formed by cutting a metal pipe, the outer frame wraps the outer side of the valve frame and is connected with the valve frame, and a first positioning unit is integrally formed on the outer frame; the first positioning unit comprises a plurality of supporting legs arranged in the circumferential direction of the outer frame, and the supporting legs are obtained by outwards bending and forming two adjacent edges in the grids or half grids of the outer frame in the circumferential direction, so that when the outer frame is implanted into the implantation position of the inner side of the autologous valve leaflet, the first positioning unit can be supported on the inner side of the autologous valve ring; the valve support is limited to move in the direction opposite to the heart blood flow direction. When the valve support is anchored through the outer support, the valve support provided with the outer support can still have the small radial size, and the implanting difficulty of the valve and the requirement for a conveying system are lowered.

Description

Technical Field

[0001] The present invention belongs to the field of biomedical technology, and in particular relates to a valve stent, an aortic valve and a mitral valve. Background Art

[0002] Heart valve disease usually includes two categories. One is valve stenosis caused by excessive calcification, which is manifested by hardening of the valve leaflets and valve rings due to calcification, restricted valve leaflet movement, increased transvalvular pressure difference, and difficulty in blood supply. The other is increased reflux due to incomplete valve closure. In this type of patients, valve calcification is not obvious.

[0003] Taking the implantation of aortic valve as an example, transcatheter aortic valve replacement technology can often only be used for patients with calcified aortic valve stenosis. For patients with aortic valve regurgitation, the autologous valve cannot provide stable anchoring for the implanted valve, which can easily cause the implanted valve to be pressed from the arterial blood vessel into the ventricle or displaced toward the distal end under the action of blood flow pressure. Although the problem of stable anchoring of the aortic valve at the implantation position can be solved by setting structures such as barbs on the valve frame of the aortic valve and anchoring the valve frame through the barbs, the setting of barbs on the valve frame will also bring about problems such as increased valve frame specifications, resulting in increased difficulty in designing the valve delivery system and increasing the difficulty of aortic valve implantation. Correspondingly, the same problem also exists in the implantation of mitral valves. Summary of the invention

[0004] The object of the present invention is to provide a valve stent, an aortic valve and a mitral valve to solve the problems existing in the implantation and anchoring of the valve.

[0005] The present invention is achieved through the following technical solutions:

[0006] Valve stent, including:

[0007] The valve frame is a grid-shaped annular support structure formed by cutting a metal tube;

[0008] The outer frame is a grid-shaped or semi-grid-shaped annular support structure formed by cutting a metal tube, the outer frame is disposed on the outer side of the valve frame and connected to the valve frame, and a first positioning unit is integrally formed on the outer frame;

[0009] The first positioning unit includes a plurality of supporting feet arranged along the circumference of the outer frame, and the supporting feet are cantilever support structures formed by bending outward two circumferentially adjacent edges of a grid or half grid of the outer frame, so that when the outer frame is implanted into the implantation position on the inner side of the native valve leaflet, the supporting feet can support the inner side of the native valve ring to limit the movement of the valve support in a direction opposite to the direction of heart blood flow.

[0010] In some embodiments, the external frame is a diamond grid-shaped or semi-grid-shaped support structure, and the supporting feet are formed by bending two sides of the grid or semi-grid outward.

[0011] In some embodiments, the outer frame is a diamond-shaped grid-like support structure, and the supporting legs are formed by truncating adjacent grids along the circumferential direction and bending two sides of the adjacent grids outward at the truncation position.

[0012] In some embodiments, the anchoring end of the supporting foot is a flat-head structure or a structure with a pointed end.

[0013] In some embodiments, the anchoring end of the supporting leg is a fork-shaped structure.

[0014] In some embodiments, the outer frame and the valve frame are connected by binding wires.

[0015] In some embodiments, the grid of the outer frame and the grid of the petal frame are arranged in a one-to-one correspondence, and a limiting groove is set at the end of the outer frame grid. The outer frame and the petal frame are connected by a binding wire at the position of the limiting groove and the binding wire falls into the limiting groove.

[0016] In some embodiments, a guide unit is disposed at one end of the outer frame, the guide unit is an annular support structure integrally formed with the outer frame, and the guide unit is disposed on the outer side of the valve frame;

[0017] The structural distribution density of the guide unit in the circumferential direction is smaller than that of the outer frame, so that when the valve stent is in a contracted state, the guide unit has a larger contraction and deformation space than the outer frame.

[0018] In some embodiments, the guide unit includes a plurality of guide feet arranged along the circumferential direction, and an end of the guide foot away from the outer frame is arranged in an inverted U-shaped or inverted V-shaped structure.

[0019] In some embodiments, the outer frame is a grid-like support structure, and a second positioning unit is integrally formed on the proximal end of the outer frame;

[0020] The second positioning unit includes a plurality of limit pins arranged along the circumference of the outer frame, and the limit pins are formed by bending outward two circumferentially adjacent edges in the grid of the outer frame, so that when the outer frame is implanted into the implantation position on the inner side of the native valve leaflet, the second positioning unit can be clamped on the end face of the native valve ring to limit the movement of the valve stent in the direction of the heart's blood flow.

[0021] On the other hand, some embodiments of the present invention further provide an aortic valve, comprising the valve support and an artificial valve disposed in the valve support;

[0022] The outer frame is arranged at the proximal end of the valve frame, and the anchoring end of the support foot is extended toward the proximal end of the outer frame to limit the movement of the aortic valve toward the proximal end.

[0023] On the other hand, some embodiments of the present invention further provide a mitral valve, comprising the valve support and an artificial valve arranged in the valve support, wherein the supporting legs are supported on the inner side of the native valve ring to limit the movement of the mitral valve toward the distal end.

[0024] In some embodiments, the anchoring end of the support leg is extended toward the proximal end of the outer frame.

[0025] In some embodiments, the anchoring end of the support leg is extended toward the distal end of the outer frame.

[0026] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0027] The valve frame and the outer frame of the valve stent of the present invention both adopt a grid structure cut from a metal tube, and a first positioning unit and a second positioning unit for anchoring are integrally formed on the outer frame, and the supporting feet and the limiting feet are formed by bending two edges of the grid. When the thickness of the outer frame is small, the supporting feet and the limiting feet can have the structural strength and rigidity required for anchoring, and can provide a stable supporting force for the valve stent. While the valve stent is anchored by the outer frame, the valve stent provided with the outer frame can still have a smaller radial dimension.

[0028] Based on the above structural design, the radial dimension of the valve stent with an outer frame provided in the present invention is only increased by 1-2F (1F is 0.33mm) compared with the size of the original valve stent; accordingly, the size of the sheath tube of the delivery system for valve implantation only needs to be increased by 1-2F, which reduces the difficulty of valve implantation and the requirements for the delivery system.

[0029] The outer frame of the valve stent of the present invention is implanted into the inner side of the native valve leaflet, and the length required for the support feet to achieve anchoring support on the native valve ring is shorter, so that the support feet can have better rigidity. In this way, when the thickness specification of the outer frame is small, it can still provide a stable anchoring support force for the valve stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0031] Figure 1It is a schematic diagram of the valve stent structure of the aortic valve according to an embodiment of the present invention.

[0032] Figure 2 It is a front view of the valve support structure of the aortic valve according to an embodiment of the present invention.

[0033] Figure 3 Schematic diagram of the valve frame structure of the aortic valve according to an embodiment of the present invention.

[0034] Figure 4 This is a schematic structural diagram of an implementation scheme of an outer frame of an aortic valve according to an embodiment of the present invention.

[0035] Figure 5 This is a front view of the structure of an embodiment of the aortic valve outer frame of the present invention.

[0036] Figure 6 This is a cutting diagram of an implementation manner of the outer frame of the aortic valve in an embodiment of the present invention.

[0037] Figure 7 This is a cutting diagram of another implementation manner of the outer frame of the aortic valve according to an embodiment of the present invention.

[0038] Figure 8 Schematic diagram of the outer frame structure formed by interlacing multiple layers of grids in the aortic valve according to an embodiment of the present invention.

[0039] Fig. 9 This is a cutting diagram of the outer frame formed by interlacing multiple layers of grids in the aortic valve according to an embodiment of the present invention.

[0040] Fig.10 Schematic diagram of the outer frame structure that can form a half grid structure in the aortic valve according to an embodiment of the present invention.

[0041] Fig.11 This is a cutting diagram of an outer frame that can form a half-grid structure in the aortic valve according to an embodiment of the present invention.

[0042] Fig.12 This is a schematic diagram of the implanted state of the aortic valve according to an embodiment of the present invention.

[0043] Fig.13 Schematic diagram of the aortic valve structure according to an embodiment of the present invention.

[0044] Fig.14 This is a schematic structural diagram of an implementation scheme of a valve stent for a mitral valve according to an embodiment of the present invention.

[0045] Fig.15 This is a schematic structural diagram of another embodiment of the valve stent for the mitral valve of the embodiment of the present invention.

[0046] Fig.16This is a cutting diagram of an implementation of an outer frame with a guide unit according to an embodiment of the present invention.

[0047] Fig.17 It is a schematic structural diagram of an expanded state of an outer frame with a guide unit according to an embodiment of the present invention.

[0048] Fig.18 This is a cutting diagram of another embodiment of an outer frame with a guide unit according to an embodiment of the present invention.

[0049] Fig.19 This is a cutting diagram of another embodiment of an outer frame with a guide unit according to an embodiment of the present invention.

[0050] Fig. 20 This is a cutting diagram of another embodiment of an outer frame with a guide unit according to an embodiment of the present invention.

[0051] in:

[0052] 10. Petal frame;

[0053] 20, outer frame, 201, grid, 202, connecting part, 203, limiting groove, 21, supporting foot, 211, anchoring end, 22, limiting foot, 23, guiding foot;

[0054] 30. artificial valve, 31. valve leaflets, 32. sealing skirt;

[0055] 41. Autologous valve leaflets, 42. Autologous valve annulus. DETAILED DESCRIPTION

[0056] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

[0057] In order to solve the problem of anchoring the implanted valve, traditional implanted valves usually use anchoring feet or anchoring stents to provide support for the valve stent. The support and anchoring method used is usually to support the anchoring stent on the native valve ring. The anchoring stent is usually set on the outside of the native valve leaflet so that the anchoring stent can be stably supported on the native valve ring.

[0058] The problem with this anchoring method is that, due to the need to match the native valve leaflets and enable the anchoring stent to support the native valve ring, the anchoring stent usually needs to have a certain length, resulting in a larger size of the anchoring stent and poor rigidity. To ensure the rigidity of the anchoring stent, it needs to have a larger thickness. The setting of this anchoring stent structure on the implanted valve tends to greatly increase the overall size of the implanted valve, so that during the implantation operation, the sheath size required on the delivery system will be greatly increased. We know that due to the limitation of the size of human blood vessels, the size of the sheath of the delivery system will directly affect the implantation operation of the valve. Therefore, every 1F increase in the radial size of the valve stent in the contracted state will greatly increase the design size of the sheath of the delivery system and the difficulty of valve implantation.

[0059] One of the purposes of the improvement made to the valve stent by the present invention is to minimize the increase in the radial dimension of the valve while achieving stable support for the valve.

[0060] In some embodiments, reference Figure 1 , Figure 2 , Figure 3 and Figure 4 , the valve stent includes:

[0061] The valve frame 10 is a grid-shaped annular stent structure cut and formed by a metal tube and is used to set an artificial valve;

[0062] The outer frame 20 is a grid-shaped or semi-grid-shaped annular support structure formed by cutting a metal tube, the outer frame is disposed on the outer side of the valve frame and connected to the valve frame, and a first positioning unit is integrally formed on the outer frame;

[0063] The first positioning unit includes a plurality of supporting feet 21 arranged along the circumference of the outer frame. The supporting feet are cantilever support structures formed by bending outward two circumferentially adjacent edges of the grid or half grid of the outer frame, so that when the outer frame is implanted into the implantation position on the inner side of the native valve leaflet, the anchoring end of each supporting foot can be supported on the inner side of the native valve ring to limit the movement of the valve support in the direction opposite to the direction of cardiac blood flow.

[0064] Taking the aortic valve as an example, the blood flow of the heart flows outward from the ventricles. At this time, the support leg supports the valve to limit the movement of the aortic valve toward the ventricles, so as to solve the problem that the aortic valve is easily moved toward the ventricles and slides into the ventricles under the action of blood flow pressure.

[0065] The valve stent provided in the embodiment of the present invention can be used in stent systems such as aortic valve, mitral valve, tricuspid valve, etc. In addition to self-expanding stents, it can also be applied to other types of stents, such as balloon-expandable and mechanically-expandable valves.

[0066] In some embodiments, the outer frame 20 is a diamond grid or semi-grid support structure, and the support legs 21 are formed by bending two sides of the grid or semi-grid outward. Figure 4 , Fig.10 Taking the outer frame of the diamond grid structure as an example, the outer frame is formed by connecting multiple diamond grids in the circumferential direction, and the support feet on the outer frame are V-shaped bracket structures formed by two adjacent edges of two adjacent diamond grids, or formed by bending two edges of the same diamond grid. Fig.10 It is a diamond-shaped half-grid structure, and the support foot is a cantilever support structure formed by bending two sides of the half-grid outward. At this time, the support foot is a support structure with two elastic arms, so that the support foot can have higher structural strength and rigidity.

[0067] In some embodiments, the outer frame is a diamond-shaped grid-shaped support structure, and the support legs are formed by truncating adjacent grids along the circumferential direction and bending two sides of the adjacent grids outward at the truncation position. Figure 4 , Fig.10 Taking the structure shown in as an example, a structure in which the support legs 21 and the connection parts 202 of the grid are staggered is formed along the circumference of the outer frame.

[0068] In some embodiments, reference Figure 4 , Figure 5 , Figure 6 and Figure 7 The anchoring end of the supporting foot used to support the autologous valve ring can be set to a flat-head structure or a structure with a pointed tip. In this case, the anchoring end 211 of the supporting foot is used to connect with the autologous valve ring, and the structure of the anchoring end is set so that the supporting foot can form a stable connection with the autologous valve ring.

[0069] Taking the structure with a pointed end as an example, refer to Figure 7 The anchoring end of the support leg is a fork-shaped structure, that is, the anchoring end 211 of the support leg has two tips, which can form a stable and reliable connection between the anchoring end and the native valve ring. This fork-shaped anchoring end is easy to achieve in the cutting and molding of the external frame.

[0070] The outer frame can be configured as a structure in which multiple layers of diamond grids 201 are staggered in the axial direction according to the type of the valve frame and the required supporting position of the supporting foot; Figure 8 and Fig. 9 Taking the structure shown as an example, the outer frame is a structure formed by two layers of diamond grids staggered in the axial direction. At this time, the axial size of the outer frame is 1.5 times the diagonal of the diamond grid, and the support foot 21 is formed by bending the two sides of the diamond grid near the distal end. In this way, when the size of the diamond grid is small, the support foot can be adjusted to the required support position by setting the number of layers of the diamond grid and forming the support foot at the appropriate position.

[0071] The external frame can also adopt other structural forms. Fig.10 and Fig.11 Taking the structure shown in the figure as an example, the outer frame obtained by cutting and forming is a serpentine structure connected in sequence at the head and tail, and the two sides spaced in sequence are bent outward to form the supporting feet. Fig.10 The semi-grid annular support structure shown in . This outer frame can also well match the structure of the valve frame, can form a good connection with the valve frame when it is sleeved on the valve frame, and occupies less space.

[0072] The outer frame is made of thin-walled metal tubes, which are cut into a grid structure by laser, and the connecting parts of the grid are cut, and then formed after post-forming and heat treatment.

[0073] The outer frame can be made of the same material as the valve frame, or other materials that can be used for valve stents.

[0074] The outer frame and the petal frame can be connected by binding wires, or by other connection methods such as welding or riveting.

[0075] It is easy to understand that the outer frame and the valve frame serving as the valve stent have two different forms, one is the contracted form when installed in the sheath of the delivery system, and the other is the expanded form that can expand to fit the human tissue after implantation.

[0076] When the binding wire is used for connection, the grids of the outer frame and the grids of the petal frame are arranged in one-to-one correspondence, and a limiting groove 203 is arranged at the end of the outer frame grid, and the binding wire is used to connect the outer frame and the petal frame at the position where the limiting groove is located, and the binding wire falls into the limiting groove 203. The displacement of the outer frame in the circumferential direction is limited by the cooperation between the limiting groove and the binding wire, so as to achieve a stable connection between the outer frame and the petal frame.

[0077] Although the outer frame arranged on the outside of the valve frame has a good size, a protruding step structure is formed on the circumferential surface of the valve frame at the end of the outer frame. When the valve stent is installed into the sheath tube of the delivery system, the step structure will be stuck at the end of the sheath tube, making it difficult to install the valve stent into the sheath tube.

[0078] To address this problem, in some embodiments, reference is made to Fig.16 , Fig.17 , Fig.18 , Fig.19 and Fig. 20A guide unit is provided at one end of the outer frame. The guide unit is an annular support structure integrally formed with the outer frame. The guide unit and the outer frame are obtained by integrally cutting and forming a metal tube. The guide unit is actually a part of the outer frame. The guide unit and the outer frame are distinguished only for the convenience of expression. Similarly, the guide unit is provided on the outer side of the petal frame. It is easy to understand that based on the role of the guide unit, the guide unit is provided on the end of the outer frame facing the installation direction.

[0079] The structural distribution density of the guide unit in the circumferential direction is less than that of the outer frame, so that when the valve stent is in a contracted state, the guide unit has a larger contraction and deformation space than the outer frame. Fig.16 , Fig.19 and Fig. 20 , the structural distribution density of the guide unit and the outer frame in the circumferential direction refers to the sparseness of the distribution of the structural parts contained in the guide unit or the outer frame in the circumferential direction. Usually, in order to ensure that the outer frame has sufficient structural strength, the structural parts of the outer frame are arranged densely in the contracted state, while the guide unit does not need to have high structural strength and can be set to a sparsely distributed structure. Obviously, this guide unit with a sparse distribution setting can have a larger shrinkage and deformation space than the outer frame in the contracted state; when the outer frame with the guide unit is installed in the sheath tube, since the guide unit is more easily squeezed and deformed in the radial direction, the guide unit can be more easily installed in the sheath tube. When the guide unit enters the sheath tube, the guide unit can play a guiding role in the installation of the outer frame, so that the outer frame can be easily installed in the sheath tube.

[0080] The guide unit includes a plurality of guide feet 23 arranged along the circumferential direction. The guide feet 23 are arranged at intervals relative to the grid structure of the outer frame in the circumferential direction, forming a sparse distribution on the outer frame.

[0081] Reference Fig.16 and Fig.18 , the guide foot 23 can be set to be an inverted U shape; refer to Fig.19 and Fig. 20 The guide foot can also be set to an inverted V shape, so that the end of the guide foot 23 presents an inverted U-shaped, inverted V-shaped gradual transition structure. Based on the same principle, this transition gradual structure can make it easier for the guide unit to be installed in the sheath tube at the end. Of course, if Fig.19 , Fig. 20 As shown, some transition connection structures may be provided between the guide pin and the outer frame, such as a grid structure with a larger mesh size, so that a guide structure with a gradually changing sparseness degree may be formed in the direction from the guide pin to the outer frame.

[0082] In some embodiments, the outer frame 20 is a grid-like support structure, and a second positioning unit is integrally formed on the outer frame at the proximal end;

[0083] The second positioning unit includes a plurality of limiting feet 22 arranged along the circumference of the outer frame, and the limiting feet 22 are formed by bending outward two adjacent edges in the circumferential direction of the grid of the outer frame, so that when the outer frame is implanted at the implantation position inside the native valve leaflet, the second positioning unit can be clamped on the end surface of the native valve ring to limit the movement of the valve stent in the direction of the heart blood flow; Figure 4 and Fig.12 shown.

[0084] This type of external frame with a second positioning unit is usually used in a valve stent for an aortic valve. The first positioning unit on the external frame is arranged close to the distal end of the external frame, and the second positioning unit is arranged at the proximal end of the external frame. The limiting cooperation between the limiting foot of the second positioning unit and the end face of the native valve ring is used to limit the movement of the valve stent toward the distal end, so as to solve the problem that the aortic valve is pushed toward the aortic blood vessel under the action of the cardiac diastolic pressure.

[0085] Based on the improvements made to the valve stent structure in the present invention, on the other hand, some embodiments of the present invention further provide an aortic valve, including:

[0086] The valve frame 10 is a grid-shaped annular stent structure formed by cutting a metal tube, and an artificial valve 30 is arranged in the valve frame; the artificial valve 30 includes a valve leaf 31 and a sealing skirt 32, Fig.13 As shown;

[0087] The outer frame 20 is a grid-shaped or semi-grid-shaped annular stent structure formed by cutting a metal tube. The outer frame is disposed on the outer side of the proximal end of the valve frame and connected to the valve frame. A first positioning unit is integrally formed on the outer frame 20.

[0088] The first positioning unit includes a plurality of supporting feet 21 arranged along the circumference of the outer frame. The supporting feet 21 are cantilever support structures formed by bending outward two circumferentially adjacent edges of a grid or half grid of the outer frame, so that when the outer frame is implanted into the implantation position on the inner side of the native valve leaflet, the first positioning unit can be supported on the inner side of the native valve ring to limit the movement of the aortic valve toward the proximal end.

[0089] A second positioning unit is integrally formed on the proximal end of the outer frame 20; the second positioning unit includes a plurality of limiting feet 22 arranged along the circumference of the outer frame, and the limiting feet 22 are formed by bending outwardly two circumferentially adjacent edges in the grid of the outer frame, so that when the outer frame is implanted at the implantation position on the inner side of the native valve leaflet, the second positioning unit can be clamped on the end face of the native valve ring to limit the movement of the aortic valve toward the distal end.

[0090] The anchoring end of the support foot 21 is extended toward the proximal end of the outer frame, and the limiting foot 22 is also extended toward the proximal end of the outer frame; at this time, the support foot and the limiting foot on the outer frame are both cantilever structures arranged in the same direction. The outer frame of this structure can be better installed in the sheath tube in the contracted state, thereby facilitating the implantation operation of the valve stent.

[0091] The outer frame 20 is a hollow grid structure, referring to Figure 4 Taking the outer frame of the diamond grid structure as an example, the limit foot on the outer frame is a V-shaped bracket structure formed by two sides of the diamond grid. At this time, the limit foot is a bracket structure with two elastic arms, so that it can have higher structural strength and rigidity.

[0092] The limiting feet 22 are formed by bending outwardly the two edges of the grid close to the heart end, so that when the external frame is implanted in the position of the native valve ring, it can be stuck on the end surface of the native valve ring to play a limiting role.

[0093] The limiting feet on the outer frame 20 can be arranged in a diamond grid arrangement with a spacing between two adjacent limiting feet, or other arrangements can be adopted.

[0094] Based on the elasticity of the supporting feet and the limiting feet, when the aortic valve stent is contracted and stored in the sheath of the delivery system, the supporting feet and the limiting feet can be attached to the contracted valve stent; and because the supporting feet and the limiting feet are both extended toward the distal end, it is convenient to store the supporting feet and the limiting feet in the sheath, making the implantation operation of the aortic valve convenient.

[0095] When this aortic valve is formed, refer to Fig.13 , set the outer frame 20 to the proximal end of the valve frame, then fold the sealing skirt 32 of the artificial valve outward and cover it to the outside of the outer frame 20, and then use sutures to connect the sealing skirt, the outer frame and the valve frame.

[0096] Reference Fig.12 When the aortic valve is implanted into the human body, in the expanded state, the supporting feet 21 of the external frame 20 are located on the inner side of the native valve leaflets 21 and supported at the position where the native valve ring 42 is located, and the limiting feet 22 of the external frame 20 are cooperated and clamped on the end surface of the native valve ring. Through the cooperation between the supporting feet, the limiting feet and the native valve ring, the aortic valve is stably anchored at the implantation position.

[0097] Based on the improvement of the valve support structure in the present invention, on the other hand, some embodiments of the present invention also provide a mitral valve, referring to Fig.14 and Fig.15 ,include:

[0098] The valve frame is a grid-shaped annular stent structure formed by cutting a metal tube, and an artificial valve is arranged in the valve frame;

[0099] The outer frame is a grid-shaped or semi-grid-shaped annular support structure formed by cutting a metal tube. The outer frame is arranged on the outer side of the proximal end of the valve frame and connected to the valve frame. A first positioning unit is integrally formed on the outer frame.

[0100] The first positioning unit includes a plurality of supporting feet arranged along the circumference of the outer frame, and the supporting feet are formed by bending outwardly two circumferentially adjacent edges in the grid of the outer frame, so that when the outer frame is implanted into the implantation position on the inner side of the native valve leaflet, the first positioning unit can be supported on the inner side of the native valve ring to limit the movement of the mitral valve toward the distal end.

[0101] like Fig.14 The anchoring end 211 of the support foot 21 is extended toward the proximal end of the outer frame. The mitral valve of this structure is usually suitable for implantation via the femoral artery.

[0102] like Fig.15 The anchoring end 211 of the support leg 21 is extended toward the distal end of the outer frame. The mitral valve of this structure is usually suitable for transapical implantation.

[0103] Along the axial direction of the outer frame, the first positioning unit can be set in two groups, and the two groups of first positioning units include a plurality of support feet arranged along the circumference of the outer frame. Taking the outer frame of the diamond grid structure as an example, one group of support feet 21 is formed by truncating adjacent grids along the circumference and bending the two sides of the adjacent grids outward at the truncation position, and the other group of support feet 21 is formed by bending the two sides of the grid outward, and the two groups of support feet are staggered in the circumferential direction.

[0104] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. used to indicate the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship commonly placed when the product of the invention is used. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0105] In addition, if the terms "horizontal" or "vertical" appear in the description of the present invention, it does not mean that the components are required to be absolutely horizontal or suspended, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0106] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood in combination with specific circumstances.

[0107] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Any simple modification or equivalent change made to the above embodiment based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A valve stent, characterized in that: include: The valve frame is a grid-shaped annular support structure formed by cutting a metal tube; The outer frame is a grid-shaped or semi-grid-shaped annular support structure formed by cutting a metal tube, the outer frame is disposed on the outer side of the valve frame and connected to the valve frame, and a first positioning unit is integrally formed on the outer frame; The first positioning unit includes a plurality of supporting feet arranged along the circumference of the outer frame, and the supporting feet are cantilever support structures formed by bending outward two circumferentially adjacent edges of a grid or half grid of the outer frame, so that when the outer frame is implanted into the implantation position on the inner side of the native valve leaflet, the supporting feet can support the inner side of the native valve ring to limit the movement of the valve support in a direction opposite to the direction of heart blood flow.

2. The valve stent according to claim 1, characterized in that: The outer frame is a diamond grid-shaped or semi-grid-shaped support structure, and the supporting feet are formed by bending two sides of the grid or semi-grid outwards.

3. The valve stent according to claim 1, characterized in that: The outer frame is a diamond-shaped grid-shaped support structure, and the support legs are formed by truncating adjacent grids along the circumferential direction and bending two sides of the adjacent grids outward at the truncation position.

4. The valve stent according to any one of claims 1 to 3, characterized in that: The anchoring end of the supporting foot is a flat-head structure or a structure with a pointed end.

5. The valve stent according to any one of claims 1 to 3, characterized in that: The anchoring end of the supporting foot is a fork-shaped structure.

6. The valve stent according to any one of claims 1 to 3, characterized in that: The outer frame and the valve frame are connected by binding wires.

7. The valve stent according to claim 6, characterized in that: The grids of the outer frame and the grids of the petal frame are arranged in a one-to-one correspondence, and a limiting groove is arranged at the end of the outer frame grid. A binding wire is used to connect the outer frame and the petal frame at the position of the limiting groove and the binding wire falls into the limiting groove.

8. The valve stent according to claim 1, characterized in that: A guide unit is disposed at one end of the outer frame, and the guide unit is an annular support structure formed integrally with the outer frame, and the guide unit is disposed on the outer side of the valve frame; The structural distribution density of the guide unit in the circumferential direction is smaller than that of the outer frame, so that when the valve stent is in a contracted state, the guide unit has a larger contraction and deformation space than the outer frame.

9. The valve stent according to claim 8, characterized in that: The guide unit comprises a plurality of guide feet arranged along the circumferential direction, and one end of the guide foot away from the outer frame is arranged in an inverted U-shaped or inverted V-shaped structure.

10. The valve stent according to claim 1 or 8, characterized in that: The outer frame is a grid-shaped support structure, and a second positioning unit is integrally formed on the proximal end of the outer frame; The second positioning unit includes a plurality of limit pins arranged along the circumference of the outer frame, and the limit pins are formed by bending outward two circumferentially adjacent edges in the grid of the outer frame, so that when the outer frame is implanted into the implantation position on the inner side of the native valve leaflet, the second positioning unit can be clamped on the end face of the native valve ring to limit the movement of the valve stent in the direction of the heart's blood flow.

11. An aortic valve, characterized in that A valve stent comprising any one of claims 1 to 10 and an artificial valve arranged in the valve stent; The outer frame is arranged at the proximal end of the valve frame, and the anchoring end of the support foot is extended toward the proximal end of the outer frame to limit the movement of the aortic valve toward the proximal end.

12. A mitral valve, characterized in that It comprises the valve support as described in any one of claims 1 to 9 and an artificial valve arranged in the valve support, wherein the supporting legs are supported on the inner side of the native valve ring to limit the movement of the mitral valve toward the distal end.

13. The mitral valve according to claim 12, characterized in that: The anchoring end of the support foot is extended toward the proximal end of the outer frame.

14. The mitral valve according to claim 12, characterized in that: The anchoring end of the support foot is extended toward the distal end of the outer frame.

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