Split aortic valve stent

Abstract

The application discloses a split aortic valve stent, which comprises a compressible and inflatable stent body and an anchor, the stent body has an inflow end and an outflow end along an axial direction, the outflow end of the stent body has three connection groups, each connection group is provided with two connection hanging points, each connection hanging point is provided with a stent connection hole, the anchor is composed of three V-shaped connecting rods connected in head-to-tail mode, the junction of adjacent connecting rods is provided with an anchor connection hole and an extension hanging rod, and the stent connection hole and the anchor connection hole are connected through a flexible connecting medium. In the application, the anchor and the stent body are connected through the flexible connecting medium in a split mode, the anchor and the stent body are connected through the flexible medium, so that the anchor and the stent body have a certain overlap in the diameter direction when clamping the human body's own valve leaflets, stronger clamping force is obtained, and the anchoring effect is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of transcatheter aortic valve replacement, in particular to a split aortic valve stent. BACKGROUND

[0002] With the continuous extension of the average life expectancy and the increasingly serious global population aging trend, the incidence of heart valve disease shows a significant increasing trend. In elderly patients, the incidence of heart valve disease ranks third, only next to hypertension and coronary heart disease, with an incidence of 13.3%.

[0003] Heart valve disease includes aortic valve disease, mitral valve disease, tricuspid valve disease, and pulmonary valve disease. Among them, aortic valve disease includes aortic valve stenosis and aortic valve regurgitation. Aortic valve stenosis is mainly caused by valve leaflet calcification, which leads to a decrease in valve leaflet opening area, so that the blood in the left ventricle cannot flow to the aorta, resulting in an increase in intraventricular pressure. Aortic valve regurgitation is mainly in diastole, and the valve leaflet cannot completely close, resulting in blood flowing to the left ventricle, causing an increase in intraventricular pressure.

[0004] In recent years, due to the advantages of small trauma and rapid recovery, transcatheter aortic valve replacement has gradually become a replacement method for surgical operation and is applied to the treatment of aortic valve disease. However, the current transcatheter aortic valve replacement mainly treats aortic valve stenosis disease, mainly represented by the ball expansion valve of Edward Company's Sapien series and the self-expanding valve of Medtronic Company's CoreValve series. There is no mature product on the market that can achieve the purpose of treating aortic valve regurgitation and aortic valve stenosis disease.

[0005] In the prior art, the difficulty in treating aortic valve regurgitation is that aortic valve regurgitation disease does not have a certain degree of valve leaflet calcification compared with aortic valve stenosis disease, and the human body's own valve leaflet is relatively soft, so that the implantation of the valve stent has the problems of positioning difficulty and anchoring difficulty.

[0006] Patent No. CN103002833B: Artificial heart valve and transcatheter delivery endoprosthesis comprising artificial heart valve and stent, discloses an artificial heart valve for transcatheter delivery endoprosthesis used in the treatment of heart valve stenosis (narrow) and / or heart valve insufficiency. In order to solve the above-mentioned purpose of treating aortic valve regurgitation, a positioning arch structure is designed to bear the function of automatic positioning of the stent, and in combination with experiments and other methods, it can be predicted that the positioning arch structure can also clamp the human body's own valve leaflet between the stent and the positioning arch structure when the stent is completely released, so that the artificial heart valve has a better anchoring effect.

[0007] However, in more experiments, it is shown that the artificial heart valve disclosed in the CN103002833B patent is an integral forming structure, and its manufacturing process generally includes laser cutting of metal pipe, heat treatment shaping, leaflet suturing, etc., so that the positioning arch structure does not overlap with the stent, and the body's own leaflet is clamped between the stent and the positioning arch structure, but since there is no overlapping area, the clamping force and anchoring effect cannot meet the needs of some patients. And the aortic valve sinus depth of different patients is different, the height of the three positioning arch structures of the above artificial heart valve is the same, and the corresponding depth cannot be adjusted according to the physiological characteristics of different patients to realize the automatic positioning function. SUMMARY

[0008] Therefore, the purpose of the present application is to solve the above problems of the prior art, and to provide a split type aortic valve stent.

[0009] To solve the above technical problems, the technical scheme of the present application is as follows:

[0010] A split type aortic valve stent, comprising a compressible and expandable stent body and an anchor, the stent body is composed of multiple layers of mesh frames, the stent body has an inflow end and an outflow end along the axial direction, the outflow end of the stent body has three connection groups, each connection group is provided with two connection hanging points, each connection hanging point is provided with a stent connection hole, and a V-shaped valley is arranged between adjacent connection groups;

[0011] The anchor is composed of three V-shaped connecting rods connected end to end, the junction of adjacent connecting rods is provided with an anchor connection hole and an extension hanging rod, and the stent connection hole and the anchor connection hole are connected through a flexible connecting medium;

[0012] When the anchor reaches the sinus bottom of the body's own leaflet, the anchor and the stent body can sandwich the body's own leaflet, and the anchor and the stent body have a certain overlap in the diameter direction.

[0013] Preferably, the flexible connecting medium is a nickel-titanium alloy material or a high molecular material suture.

[0014] Preferably, the junction of each adjacent connecting rod is provided with two anchor connection holes.

[0015] Preferably, the two connection hanging points of each connection group correspond to two anchor connection holes, and the flexible connecting medium passes through the two connection hanging points and the two anchor connection holes in sequence to form a "ladder-shaped" structure.

[0016] In the above preferred solution, the flexible connecting medium forming the "ladder-shaped" structure has a ladder-shaped quadrilateral stable structure, and in the state of full release of the anchor and the stent body, the four sides of the flexible connecting medium are kept in a "tight" state, so that the anchor and the stent body have a certain degree of freedom to automatically adapt to the optimal fitting state, and can also avoid the state of excessive sliding of the anchor relative to the stent body.

[0017] Preferably, the direction of the extension hanging rod is toward the outflow end of the axis direction, and the extension hanging rod is connected with a delivery system for delivering the split aortic valve stent.

[0018] Further, when the anchor reaches the sinus floor of the human body autograft leaflet, the two V-shaped valleys of the stent body are toward the human body coronary orifice.

[0019] Further, the multi-layer mesh framework of the stent body includes diamond meshes and special-shaped meshes, and the two sides of the V-shaped valley are both special-shaped meshes. Due to the arrangement of the V-shaped valley toward the human body coronary orifice, the special-shaped mesh structure has a larger mesh for blood flow, so that the coronary orifice has better blood flow dynamics.

[0020] Preferably, the three V-shaped connecting rods of the anchor all have a height adapted to the depth of the sinus floor of the human body autograft leaflet.

[0021] Preferably, the anchor and the stent body are both made of nickel-titanium alloy.

[0022] The technical solution of the present application has the following advantages:

[0023] 1. The split aortic valve stent provided by the present application adopts a split structure of the anchor and the stent body connected by a flexible connecting medium, realizes the effect that the shape of the anchor and the height of each V-shaped connecting rod can be freely adjusted, and is suitable for the physiological structure of different patients; and through the connection of the flexible medium, when the anchor and the stent body clamp the human body autograft leaflet, the anchor and the stent body have a certain

[0024] overlap in the diameter direction, so as to obtain stronger clamping force and further improve the anchoring effect. BRIEF DESCRIPTION OF DRAWINGS

[0025] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiments or prior art description. Obviously, the drawings in the following description are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0026] Figure 1is a three-dimensional structure schematic diagram of a split aortic valve stent provided by the present application in an embodiment;

[0027] Figure 2 is a three-dimensional schematic diagram of a stent body provided by the present application in an embodiment Figure 1 ;

[0028] Figure 3 is a three-dimensional schematic diagram of a stent body provided by the present application in an embodiment Figure 2 ;

[0029] Figure 4 is a three-dimensional schematic diagram of an anchor provided by the present application in an embodiment.

[0030] Label explanation: 1, stent body, 2, anchor, 3, flexible connection medium, 11, connection group, 12, connection hanging point, 13, stent connection hole, 14, V-shaped wave trough, 15, special-shaped hole, 16, rhombic hole, 21, connecting rod, 22, anchor connection hole, 23, extension hanging rod, 101, inflow end, 102, outflow end. DETAILED DESCRIPTION

[0031] The technical solutions of the present application will be described clearly and completely below in conjunction with the drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0032] In the description of the present application, it should be noted that the orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first", "second", "third" are only for the purpose of description,

[0033] and cannot be understood as indicating or implying relative importance.

[0034] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0035] In addition, the technical features involved in the different embodiments of the application described below can be combined with each other as long as they do not conflict with each other.

[0036] As shown in Figures 1-4 A split aortic valve stent, a split aortic valve stent, a split aortic valve stent, comprising a compressible and inflatable stent body 1 and an anchor 2, the stent body 1 is composed of multiple layers of mesh frame, the stent body has an inflow end 101 and an outflow end 102 along the axial direction, the outflow end 102 of the stent body 1 has three connection groups 11, each connection group is provided with two connection hanging points 12, each connection hanging point 12 is provided with a stent connection hole 13, and a V-shaped valley 14 is arranged between adjacent connection groups.

[0037] As shown in Figure 4 The anchor 2 is composed of three V-shaped connecting rods 21 connected end to end, the junction of adjacent connecting rods 21 is provided with an anchor connection hole 22 and an extension hanging rod 23, and the stent connection hole 13 and the anchor connection hole 22 are connected through a flexible connecting medium 3.

[0038] When the anchor 2 reaches the sinus floor of the human body's native valve leaflet, the anchor 2 and the stent body 1 can sandwich the human body's native valve leaflet, and the anchor and the stent body have a certain overlap in the diameter direction.

[0039] In a preferred embodiment, the flexible connecting medium is a high molecular material suture. Through appropriate experimental adjustment, a nickel-titanium alloy material processed by a heat treatment forming process can also be used, wherein the nickel-titanium alloy material can be a single wire or a plurality of single nickel-titanium alloy wires wound together.

[0040] As shown in Figure 4 In this embodiment, the junction of each adjacent connecting rod is provided with two anchor connection holes 22.

[0041] In this embodiment, the two connection hanging points 13 of each connection group correspond to two anchor connection holes 22, and the flexible connecting medium 3 passes through the two connection hanging points 13 and the two anchor connection holes 22 in sequence, forming a "ladder-shaped" structure.

[0042] As shown in Figure 1As shown, in the preferred embodiment, the flexible connecting medium forming the "ladder-shaped" structure has a ladder-shaped quadrilateral stabilizing structure, and in the state where the anchor and the stent body are completely released, the four sides of the flexible connecting medium are kept in a "tight" state, so that the anchor and the stent body can automatically adapt to the optimal fitting state with a certain degree of freedom, and can also avoid the state where the anchor slides excessively relative to the stent body.

[0043] In a preferred embodiment, the extension hanging rod 23 is directed towards the outflow end 102 of the axis direction, and the extension hanging rod 102 is connected with a delivery system (not shown in the figure) for delivering a split aortic valve stent.

[0044] In another preferred embodiment, when the anchor 2 reaches the sinus floor of the human native valve leaflet, the two V-shaped valleys 14 of the stent body 1 are directed towards the human coronary orifice.

[0045] Please refer to Figure 3 As shown, in the embodiment, the multi-layer mesh framework of the stent body includes diamond meshes 16 and special-shaped meshes 15, and the two sides of the V-shaped valley 14 are both special-shaped meshes 15 (as shown by the area with black lines in the figure). Due to the arrangement of the V-shaped valley 14 towards the human coronary orifice, the structure of the special-shaped mesh 15 has a larger mesh for blood flow, so that the coronary orifice has a better blood flow dynamics. Figure 3

[0046] In the embodiment, the three V-shaped connecting rods 21 of the anchor 2 all have a height that is adapted to the depth of the sinus floor of the human native valve leaflet.

[0047] In the embodiment, the anchor 2 and the stent body 1 are both made of nickel-titanium alloy.

[0048] Since the anchor and the stent body are not integrally formed, the shape of the anchor and the height of the connecting rod can be customized in multiple models, which has higher adaptability and lower customization cost than the existing technology, and can also be assembled with the standardized stent body through the flexible connecting medium before the operation, which is beneficial to reduce the production cost and improve the adaptability to different patients.

[0049] Obviously, the above embodiments are only examples for clearly illustrating, but not limiting the embodiments. Based on the above description, other different forms of changes or variations can be made by those skilled in the art. Here, all the embodiments need not and cannot be exhausted. The obvious changes or variations derived therefrom are still within the protection scope of the present application.​

Claims

1. A split aortic valve stent, characterized in that, The stent body is composed of multiple layers of mesh frames, and has an inflow end and an outflow end along the axial direction, the outflow end of the stent body has three connection groups, each connection group is provided with two connection hooks, each connection hook is provided with a stent connection hole, and V-shaped valleys are arranged between adjacent connection groups; The anchor is composed of three V-shaped connection rods connected end to end, the junction of adjacent connection rods is provided with an anchor connection hole and an extension hook rod, and the stent connection hole and the anchor connection hole are connected through a flexible connection medium; When the anchor reaches the sinus floor of the human body's native valve leaflet, the anchor and the stent body can sandwich the human body's native valve leaflet, and the anchor and the stent body have a certain overlap in the diameter direction; The junction of each adjacent connection rod is provided with two anchor connection holes, the two connection hooks of each connection group correspond to the two anchor connection holes, the flexible connection medium passes through the two connection hooks and the two anchor connection holes in sequence, and a "ladder-shaped" structure is formed.

2. The split aortic valve stent of claim 1, wherein, The flexible connection medium is made of nickel-titanium alloy or high molecular material suture.

3. The split aortic valve stent of claim 1, wherein, The direction of the extension hook rod is toward the outflow end of the axial direction, and the extension hook rod is connected with a delivery system for delivering a split aortic valve stent.

4. The split aortic valve stent of claim 1, wherein, When the anchor reaches the sinus floor of the human body's native valve leaflet, the two V-shaped valleys of the stent body face the human body's coronary orifice.

5. The split aortic valve stent of claim 4, wherein, The multiple layers of mesh frames of the stent body include diamond-shaped mesh and special-shaped mesh, and the two sides of the V-shaped valley are special-shaped mesh.

6. The split aortic valve stent of claim 1, wherein, The three V-shaped connection rods of the anchor have a height adapted to the depth of the sinus floor of the human body's native valve leaflet.

7. The split aortic valve stent of claim 1, wherein, The anchor and the stent body are made of nickel-titanium alloy.

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