Recoverable heart valve stent and heart valve device

Abstract

The utility model discloses a recoverable heart valve stent and a heart valve device, the recoverable heart valve stent comprises: an outer stent, a grid located at an outflow end on the outer stent bends and extends inwards to form three locking tail ends, the three locking tail ends are uniformly distributed along the circumferential direction of the outer stent; the outer support is provided with connecting rods extending towards the interior of the outer support, the intersection point of the two connecting rods forms a connecting point, and three connecting points evenly distributed along the circumference are arranged in the outer support. The inner valve frame is arranged in the outer support, and the inner valve frame is connected to the outer support through the connecting point. The heart valve device comprises a heart valve support and an artificial valve, and a valve ring of the artificial valve is provided with a plurality of cavities. And the recovery control is simple and convenient.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical equipment, and in particular relates to a recyclable heart valve stent and a heart valve device. Background Art

[0002] After the heart valve device is delivered to the heart by the valve delivery device, it may not be positioned accurately after being released, which may affect the working effect, such as whether the valve opening and closing is normal, whether the anti-valvular leakage design of the skirt position works, etc. Therefore, it is necessary to recover the heart valve device and repeat the positioning before it is completely unlocked to ensure the working effect of the heart valve device.

[0003] However, current heart valve stents are mostly focused on their working effects during implantation, and the stent structure is complex in design, especially the double-layer stent structure is more complex, which makes it difficult to control or impossible to recycle during recovery. Summary of the invention

[0004] The utility model aims to provide a recyclable heart valve stent and a heart valve device, so as to solve the problem that the heart valve stent is difficult to control or cannot be recycled.

[0005] The technical solution is as follows:

[0006] The recyclable heart valve stent of the utility model comprises:

[0007] An outer bracket, wherein the grid at the outflow end of the outer bracket is bent and extended inwardly to form three locking ends, and the three locking ends are evenly distributed along the circumference of the outer bracket;

[0008] The outer bracket is provided with a connecting rod extending toward the inside of the outer bracket, the intersection of two connecting rods forms a connecting point, and the outer bracket is provided with three connecting points evenly distributed along the circumference;

[0009] The inner valve frame is arranged in the outer frame, and the inner valve frame is connected to the outer frame through the connection point.

[0010] In one of the embodiments, the inflow end of the outer bracket is connected to a flange, and the flange is provided with a plurality of grids, and each grid is provided with a plurality of grid rods extending from the same position in the grid at different angles in the grid.

[0011] In one embodiment, a plurality of first anchoring structures and second anchoring structures are provided on the outer bracket along the circumferential direction, and the second anchoring structure is located below the first anchoring structure.

[0012] In one embodiment, the second anchoring structure is connected to two adjacent connection points, each of the two connection points is connected to one of the locking ends, and the connecting arms adjacent to all the locking ends connected to the connection points of the two connection points and the second anchoring structure form an avoidance position.

[0013] In one embodiment, the first anchoring structure includes a first barb disposed on a connecting arm of the mesh of the external support, and also includes a second barb disposed on a connecting point of the mesh of the external support, and the first barb and the second barb have different heights.

[0014] In one of the embodiments, the connecting rod is provided on two adjacent connecting arms in two adjacent grids of the outer bracket, and the extending direction of the connecting rod is inclined upward.

[0015] In one embodiment, the connecting rod is a fixing member for suturing an artificial valve.

[0016] In one embodiment, there is a radial gap between the periphery of the inner valve frame and the periphery of the outer stent.

[0017] In one of the embodiments, a lower connecting edge and an upper connecting edge are further provided, and the lower connecting edge and the upper connecting edge are both sutured to the inner valve frame and the outer support.

[0018] The heart valve device of the utility model comprises:

[0019] Any one of the above heart valve stents;

[0020] The artificial valve is used for suturing on the inner valve frame of the heart valve support, and the valve ring of the artificial valve is provided with a plurality of cavities.

[0021] The technical solution provided by the utility model has the following advantages and effects:

[0022] By setting three locking ends on the heart valve stent, and the locking ends are evenly distributed along the circumference of the outer stent, the number of locking ends is small, and the control during recovery is simple and convenient. In addition, the outer stent and the inner valve stent are connected by three connecting points formed by connecting rods, and the connection between the inner valve stent and the outer stent is simple. The linkage between the outer stent and the inner valve stent can be achieved only by applying force on the locking ends, which is convenient for recovery control. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A front view of the heart valve stent provided in this embodiment;

[0024] Figure 2 A top view of the heart valve stent provided in this embodiment;

[0025] Figure 3 A three-dimensional diagram of the heart valve stent provided in this embodiment;

[0026] Figure 4 This is a front view of the heart valve stent of this embodiment after the artificial valve is sutured;

[0027] Figure 5 A top view of the heart valve stent of this embodiment after the artificial valve is sutured;

[0028] Figure 6 is a front view of the artificial valve of this embodiment;

[0029] Figure 7 is a three-dimensional diagram of the artificial valve of this embodiment;

[0030] Figure 8 is a front view of the skirt of this embodiment;

[0031] Fig. 9 This is a front view of the heart valve stent after the skirt is sutured in this embodiment;

[0032] Fig.10 A top view of the heart valve stent after the skirt is sutured in this embodiment;

[0033] Fig.11 A stereogram of an upper connecting edge / a lower connecting edge;

[0034] Fig.12 A front view of the heart valve stent after the lower connecting edge is installed in this embodiment;

[0035] Fig.13 This is a schematic diagram of the heart valve device after recovery in this embodiment.

[0036] Description of reference numerals:

[0037] 100, heart valve stent, 110, outer stent, 111, connecting arm, 112, connecting point, 113, inflow end, 114, outflow end, 115, locking end, 116, connecting point, 117, connecting rod, 118, flange, 118a, mesh rod, 119, first anchoring structure, 119a, first barb, 119b, second barb, 120, second anchoring structure, 120a, connecting arm, 121, avoidance position, 122, skirt,

[0038] 130, inner valve frame, 131, inner valve frame unit,

[0039] 150. Artificial valve, 151. Cavity,

[0040] 170, upper connecting edge, 190, lower connecting edge,

[0041] 200. Heart valve device. DETAILED DESCRIPTION

[0042] In order to facilitate the understanding of the present invention, specific embodiments of the present invention will be described in more detail below with reference to the accompanying drawings.

[0043] Unless otherwise specified or defined, the "first, second..." used in this article is merely used to distinguish names and does not represent a specific quantity or order.

[0044] Unless specifically stated or defined otherwise, the term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0045] It should be noted that, in this article, "fixed to" or "connected to" may be directly fixed or connected to an element, or may be indirectly fixed or connected to an element. "Inflow end" and "outflow end" refer to the direction in which the heart blood flows through the valve stent. Although "inflow end" and "outflow end" are not restrictive, "inflow end" generally refers to the end close to the blood flowing into the valve stent, and "outflow end" generally refers to the end close to the blood flowing out of the heart valve stent.

[0046] In view of the problem that current heart valve stents are difficult or impossible to recycle, the utility model sets three locking ends at the outflow end of the outer stent, connects the inner valve frame and the outer stent through three connection points, and the inner valve frame and the outer stent can be linked to each other, and the release and recovery operations of the inner valve frame and the outer stent are achieved through the locking ends. There are only three locking ends and only three connection points between the inner valve frame and the outer stent, so the recovery control is simple and convenient.

[0047] See also Figure 1-3 ,in, Figure 1 A front view of the heart valve stent provided in this embodiment, Figure 2 A top view of the heart valve stent provided in this embodiment, Figure 3A three-dimensional diagram of the heart valve stent provided for this embodiment. The heart valve stent 100 of this embodiment is a double-layer stent, including an outer stent 110 and an inner valve stent 130. The outer stent 110 is formed by interconnecting a number of hollow grids, most of which are similar to rhombuses, with the connecting arms 111 of the grids forming the edges of the rhombuses, and the connecting points 112 of the grids forming the vertices of the rhombuses. The connecting points 112 of one grid are connected to the connecting points 112 of another grid to achieve the interconnection between the grids. Blood flows in from the top of the outer stent 110 and flows out from the bottom of the outer stent 110. Therefore, the top is also called the inflow end 113, and the bottom is also called the outflow end 114. The grid of the outflow end 114 of the outer stent 110 is bent into the outer stent 110 and extends obliquely downward to form a locking end 115. The locking end 115 is used to connect with the heart valve delivery device to facilitate loading into the sheath and to achieve a recovery function before unlocking.

[0048] There are three locking ends 115, which are evenly distributed along the circumference of the external support 110, that is, when the center lines of the locking ends 115 are projected on the horizontal plane, the angle between each two center lines is 120 degrees. The locking ends 115 are bent inwardly of the external support 110, which can reduce the damage of the locking ends 115 to the chordae tendineae and papillary muscles.

[0049] The inner valve frame 130 is installed in the outer support 110 and is used to sew the artificial valve 150. In order to facilitate the recovery control, three connection points 116 are set on the outer support 110, and the inner valve frame 130 is connected to the outer support 110 through these three connection points 116. Specifically, two adjacent grids are selected on the outer support 110, and then the connection rods 117 that are inclined upward are connected to the two adjacent connection arms 111 in the two grids, that is, each of the two connection arms 111 is connected to a connection rod 117, and the two connection rods 117 intersect inside the outer support 110, and the intersection point is the connection point 116 for connecting the outer support 110 and the inner valve frame 130. It should be noted that the specific shape of the connecting rod 117 inclined upward is not limited. It is preferably as shown in the present embodiment, first slowly upward at a small angle to the horizontal plane and then quickly upward at a large angle, similar to an exponential curve inclined upward. The connecting rod 117 of this shape can effectively isolate the inner valve frame 130 and the outer bracket 110, and play a buffering effect; it can also be an arc inclined upward or a straight line inclined upward. A total of six connecting rods 117 are arranged on the outer bracket 110, forming three connection points 116, and the three connection points 116 are evenly distributed along the circumference. Through these three connection points 116, the inner valve frame 130 can be installed in the outer bracket 110. During recovery, based on this structure of three connection points 116 evenly distributed circumferentially in the same horizontal plane, the outer bracket 110 and the inner valve frame 130 can be linked to achieve radial contraction of the heart valve bracket 100. Since the connection between the inner valve frame 130 and the outer support 110 is simple, it is also simple and convenient to recover. Moreover, since the connection point 116 is the intersection point of the connecting rod 117, it is equivalent to setting the connecting rod 117 between the inner valve frame 130 and the outer support 110, and the connection of the inner valve frame 130 is more stable.

[0050] Since the connecting rod 117 extends upwardly and obliquely toward the inside of the outer stent 110 to form the connection point 116, a radial gap exists between the periphery of the inner valve frame 130 and the periphery of the outer stent 110, that is, there is a radial deviation between the inner valve frame 130 and the outer stent 110. When the heart valve stent is working, the connecting rod 117 forms a buffer for the inner valve frame 130, and when the outer stent 110 is deformed, the inner valve frame 130 will not be deformed, and the outer stent 110 has less interference with the coaptation of the leaflets of the artificial valve 150.

[0051] In this embodiment, when suturing the artificial valve 150, the artificial valve 150 is also sutured to the connecting rod 117, that is, the connecting rod 117 serves as a fixing part for suturing the artificial valve 150, so that the structure of the heart valve stent 100 is simpler and convenient for recovery control.

[0052] The inner valve frame 130 includes three inner valve frame units 131 evenly arranged along the circumferential direction, and each inner valve frame unit 131 is shaped like an upright brim. The top end of the inner valve frame unit 131 is located near the inflow end 113 of the outer support 110.

[0053] By connecting the locking end 115 to the heart valve stent 100 and controlling the locking end 115, the heart valve stent 100 can be released and recovered before being completely unlocked, and the positioning of the heart valve stent 100 can be repeated to ensure that the heart valve stent 100 is accurately positioned, thereby improving the working effect of the heart valve device 200 (the artificial valve 150 is installed in the heart valve stent 100 to constitute the heart valve device 200).

[0054] A flange 118 is connected to the inflow end 113 of the external support 100, and the flange 118 is formed by connecting a plurality of (12 in this embodiment) triangular grids. In order to reduce paravalvular leakage, a tree structure is also provided in each grid of the flange 118. Specifically, a plurality of grid rods 118a extend into the grid at different angles at the same position on the bottom edge of each grid, and all the grid rods 118a in each grid are connected to form a tree shape. The grid rods 118a of the above-mentioned tree-like structure can increase the contact surface between the flange 118 and the heart tissue, play the role of paravalvular sealing, and can more effectively prevent paravalvular leakage.

[0055] In order to prevent the artificial valve 150 from moving upward when the heart valve stent 100 is working after the heart valve stent 100 is unlocked, a plurality of first anchoring structures 119 and a plurality of second anchoring structures 120 are arranged circumferentially on the outer stent 100, and the second anchoring structure 120 is arranged below the first anchoring structure 119. The first anchoring structure 119 and the second anchoring structure 120 form a double anchoring structure. Specifically, the first anchoring structure 119 includes a first barb 119a and a second barb 119b of different heights, and the second barb 119b is arranged below the first barb 119a. The first barb 119a is arranged on the connecting arm 111 of the grid of the outer stent 110, and a certain position on the connecting arm 111 is bent and extended toward the outside of the outer stent 110 to form the first barb 119a, and the free end of the first barb 119a is provided with a spike. The second barb 119b is arranged on the connection point 112 of the grid of the outer stent 110, such as extending from the connection point 112 to the outside of the outer stent 110 to form the second barb 119b, and the free end of the second barb 119b is also provided with a spike. The first anchoring structure 119 is used to penetrate into the valve ring and the valve leaflet to play an anchoring role, preventing the artificial valve 150 from moving upward.

[0056] The locking end 115 is connected to the connection point 112 of the outer support 110. A second anchoring structure 120 is provided between two adjacent connection points 112 of two adjacent locking ends 115. Specifically, the second anchoring structure 120 includes two intersecting connecting arms 120a, each connecting arm 120a is connected to one connection point 112, and the second anchoring structure 120 is also called a barb. The second anchoring structure 120 is used to hook the leaflets or chordae tendineae to play an anchoring role and prevent the artificial valve 150 from moving upward. The second anchoring structure 120 and the two adjacent connecting arms of the two adjacent locking ends 115 form a vacant area, which is also called an avoidance position 121, which is used to align the ventricular outflow tract position to avoid obstruction.

[0057] Figure 4-5 The heart valve device formed by suturing the artificial valve to the inner valve frame is shown, wherein Figure 4 This is a front view of the heart valve stent of this embodiment after suturing the artificial valve. Figure 5 FIG. 1 is a top view of the heart valve stent of this embodiment after suturing the artificial valve. In order to further prevent paravalvular leakage, the artificial valve 150 used in this embodiment is as follows: Figure 6-7 As shown ( Figure 6 shows a front view of an artificial valve, Figure 7 1 shows a three-dimensional view of an artificial valve), a plurality of cavities 151 are provided at the valve ring of the artificial valve 150, and when the paravalvular leakage blood flows back into the cavity 151, a thrombus will be formed in the cavity 151, thereby blocking the paravalvular leakage gap. The shape of the cavity 151 is not limited, and a circular small hole can be sutured at the valve ring as in the present embodiment as the cavity 151, or a polygonal small hole can be sutured as the cavity 151.

[0058] A skirt 122 is also sewn onto the outer bracket 110. Figure 8 The front view of the skirt used in this embodiment. The effect of suturing to the heart valve stent is as follows Figure 9-10 As shown, Fig. 9 This is the front view of the heart valve stent after the skirt is sutured. Fig.10 This is a top view of the heart valve stent after the skirt is sutured.

[0059] In order to assist in fixing the inner valve frame 130 and prevent paravalvular leakage, an upper connecting edge 170 and a lower connecting edge 190 are provided between the inner valve frame 130 and the outer support 110. Fig.10 and Fig.12 In this embodiment, the upper connecting edge 170 and the lower connecting edge 190 have the same structure, both of which are hollow truncated cones, and the material is the same as that of the skirt, which can be a low-porosity woven fabric, such as polyester, synthetic fiber fabric or polytetrafluoroethylene fiber (PTFE). The specific structure of the upper connecting edge 170 and the lower connecting edge 190 is as follows: Fig.11The lower connecting edge 190 is sutured to the bottom end of the inner valve frame 130, and the upper connecting edge 170 is sutured to the top end of the outer support 110. Specifically, the inner periphery of the lower connecting edge 190 and the inner periphery of the upper connecting edge 170 are sutured to the inner valve frame 130, and the outer periphery of the lower connecting edge 190 and the outer periphery of the upper connecting edge 170 are sutured to the outer support 110. The upper connecting edge 170 and the lower connecting edge 190 can block the radial gap between the inner valve frame 130 and the outer support 110 to prevent paravalvular leakage and enhance the stability of the inner valve frame 130.

[0060] In summary, by setting three locking ends on the heart valve stent, and the locking ends are evenly distributed along the circumference, the number of locking ends is small, and the control during recovery is simple and convenient. In addition, the outer stent and the inner valve stent are connected by three connection points, and the connection between the inner valve stent and the outer stent is simple. The linkage between the outer stent and the inner valve stent can be achieved only by applying force on the locking ends, which is convenient for recovery control. The state of the heart valve device of this embodiment after recovery is as follows: Fig.13 In addition, a tree-like structure is provided on the flange to play the role of paravalvular sealing and more effectively prevent paravalvular leakage; a double anchoring structure is also provided on the external stent to prevent the artificial valve from moving upward.

[0061] The above embodiments are not exhaustive enumerations based on the present invention, and there may be multiple other implementations not listed. Any replacement and improvement made without violating the concept of the present invention shall fall within the protection scope of the present invention.

Claims

1. A recyclable heart valve stent, characterized in that: include: An outer bracket, wherein the grid at the outflow end of the outer bracket is bent and extended inwardly to form three locking ends, and the three locking ends are evenly distributed along the circumference of the outer bracket; The outer bracket is provided with a connecting rod extending toward the inside of the outer bracket, the intersection of two connecting rods forms a connecting point, and the outer bracket is provided with three connecting points evenly distributed along the circumference; The inner valve frame is arranged in the outer frame, and the inner valve frame is connected to the outer frame through the connection point.

2. The recyclable heart valve stent according to claim 1, characterized in that: The inflow end of the outer bracket is connected with a flange plate, and a plurality of grids are arranged on the flange plate. Each grid is provided with a plurality of grid rods extending from the same position in the grid at different angles in the grid.

3. The recyclable heart valve stent according to claim 1, characterized in that: The outer bracket is provided with a plurality of first anchoring structures and second anchoring structures along the circumferential direction, and the second anchoring structures are located below the first anchoring structures.

4. The recyclable heart valve stent according to claim 3, characterized in that: The second anchoring structure is connected to two adjacent connection points, each of the two connection points is connected to one of the locking ends respectively, and the connecting arms adjacent to all the locking ends connected to the connection points of the two connection points and the second anchoring structure form an avoidance position.

5. The recyclable heart valve stent according to claim 3, characterized in that: The first anchoring structure includes a first barb disposed on a connecting arm of the mesh of the outer support, and also includes a second barb disposed on a connecting point of the mesh of the outer support, and the first barb and the second barb have different heights.

6. The recyclable heart valve stent according to claim 1, characterized in that: The connecting rod is provided on two adjacent connecting arms in two adjacent grids of the outer bracket, and the extending direction of the connecting rod is inclined upward.

7. The recyclable heart valve stent according to claim 6, characterized in that: The connecting rod is a fixing member used for suturing the artificial valve.

8. The recyclable heart valve stent according to claim 1, characterized in that: There is a radial gap between the periphery of the inner valve frame and the periphery of the outer stent.

9. The recyclable heart valve stent according to claim 1, characterized in that: A lower connecting edge and an upper connecting edge are also provided, and the lower connecting edge and the upper connecting edge are both sutured with the inner valve frame and the outer support.

10. A heart valve device, characterized in that include: The heart valve stent according to any one of claims 1 to 9; The artificial valve is used for suturing on the inner valve frame of the heart valve support, and the valve ring of the artificial valve is provided with a plurality of cavities.

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