Valve stent for mitral valve replacement

Abstract

The invention relates to the technical field of medical instruments, in particular to a valve stent for mitral valve replacement, which comprises an integrally formed annular stent, one end of the stent extends to be provided with an anchoring part, and the other end of the stent extends to be provided with a connecting part; the connecting part comprises a connecting arm, the connecting arm comprises a bending section and a connecting section which are connected with each other, the bending section integrally extends out of the stent, and the connecting section is provided with a flexible section used for being attached to the atrial wall; the anchoring part comprises a bendable anchoring arm, and the end, away from the support, of the anchoring arm is provided with a clamping part used for anchoring the valve and a fixing part used for preventing the valve from rotating. The valve support has the advantages that anchoring performance of the valve support is enhanced, and perivalvular leakage risk is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve stent for mitral valve replacement. Background Art

[0002] As the global population ages, the incidence of heart valve disease is increasing year by year. Mitral valve disease, a common heart valve disease, is facing increasing demand for treatment. The development of minimally invasive techniques, such as transcatheter mitral valve replacement (TMVR), has provided new options for mitral valve replacement. While these minimally invasive procedures offer advantages such as minimal trauma and rapid recovery, they also present significant drawbacks and challenges.

[0003] The transfemoral mitral valve is released into the patient's body through a delivery device. However, during the operation, the anchoring effect is usually poor, and the native leaflets or chordae tendineae are damaged during the anchoring process, which may lead to valve displacement, paravalvular leakage, etc. Therefore, the existing technology needs to be improved. Summary of the Invention

[0004] The purpose of the present invention is to provide a valve stent for mitral valve replacement, aiming to solve the problem of poor valve anchoring effect in the prior art, effectively increase the anchoring performance of the valve during surgery, improve the sealing effect, and thus reduce the risk of paravalvular leakage.

[0005] The present invention is achieved through the following technical solutions: A valve stent for mitral valve replacement, comprising an integrally formed annular stent, one end of which is provided with an anchoring portion, and the other end of which is provided with a connecting portion; The connecting portion includes a connecting arm, the connecting arm includes a curved section and a connecting section connected to each other, the curved section extends integrally from the stent, and the connecting section is provided with a flexible section for fitting against the atrial wall; The anchoring portion comprises a bendable anchoring arm. An end of the anchoring arm away from the stent is provided with a clamping portion for anchoring the valve and a fixing portion for preventing the valve from rotating.

[0006] Preferably, the flexible section is provided with a continuous S-shaped structure.

[0007] Preferably, the connecting section is provided with a connecting hole, and the flexible section is located between the connecting hole and the curved section.

[0008] Preferably, the clamping portion comprises a bendable first clamping body and a second clamping body that are bifurcated and extended from one end away from the stent. The first clamping body and the second clamping body are adapted to each other and are used to clamp the valve.

[0009] Preferably, the first clamping body and the second clamping body are overlapped along the thickness direction of the anchoring arm.

[0010] Preferably, the first clamping body and the second clamping body are both configured as V-shaped clamping bodies, and one end of the V-shaped clamping body is connected to the anchoring arm.

[0011] Preferably, the connecting arm is arranged in a counterclockwise direction with the center of the bracket as a reference.

[0012] Preferably, the fixing portion comprises a groove formed in the anchoring arm, wherein a bendable anchoring member adapted thereto is provided in the groove.

[0013] Preferably, the groove includes a first through groove and a second through groove. The anchoring member in the first through groove and the anchoring member in the second through groove have the same bending direction; Or the bending direction of the anchor member in the first through groove is opposite to that of the anchor member in the second through groove.

[0014] Preferably, the anchoring member and the anchoring arm are integrally formed.

[0015] Preferably, the anchor is provided with a piercing end.

[0016] Preferably, the bracket is composed of a plurality of hollow compression units arranged circumferentially as a whole, and the anchoring portion and the connecting portion are respectively located at two ends of the compression unit.

[0017] Preferably, the compression unit includes a plurality of folding parts arranged along the folding direction of the bracket, and a connecting rod is axially arranged between the plurality of folding parts.

[0018] Preferably, the folding portion includes a first folding arm and a second folding arm, one end of the first folding arm is connected to one end of the second folding arm, and the other end of the first folding arm is arranged opposite to the other end of the second folding arm and corresponds to the folding direction.

[0019] Preferably, the connecting rod comprises a wave-shaped rod.

[0020] Compared with the prior art, the present invention has the following advantages and beneficial effects: 1. The stent in this technical solution is manufactured using an integrated molding process, which increases the compressibility of the stent, making it easier to compress and correspondingly reducing the manufacturing cost; 2. The connecting arm is flexible and can bend during valve positioning. It can be used in conjunction with the anchoring part to clamp the patient's valve annulus or atrial wall, thereby more stably fixing the valve and preventing the valve from shifting toward the ventricle or atrial side, thereby effectively increasing the anchoring effect of the valve. 3. The anchoring arm has a bendable effect. During the positioning of the valve, it can bend and then rotate to hook the chordae tendineae. At the same time, the bending and rotation process of the anchoring arm also wraps and tightens the valve, thereby effectively increasing the anchoring effect of the valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The drawings described herein are used to provide a further understanding of the embodiments of the present invention, constitute a part of this application, and do not constitute a limitation of the embodiments of the present invention. In the drawings: Figure 1 A schematic structural diagram of a valve stent for mitral valve replacement provided by an embodiment of the present invention; Figure 2 It is a partial enlarged schematic diagram of point A in the figure; Figure 3 A schematic diagram of another arrangement of anchoring members provided in an embodiment of the present invention; Figure 4 A partial schematic diagram of a valve stent for mitral valve replacement provided by an embodiment of the present invention after being flattened and unfolded; Figure 5 A schematic diagram of the compressed structure of a valve stent for mitral valve replacement provided in an embodiment of the present invention.

[0022] Markings and corresponding parts names in the accompanying drawings: 100- bracket, 110- compression unit, 111- folding portion, 112- connecting rod, 200- anchoring portion, 210- anchoring arm, 220- clamping portion, 221- first clamping body, 222- second clamping body, 230- fixing portion, 231- first through slot, 232- second through slot, 233- anchoring member, 234- piercing end, 300- connecting portion, 310- connecting arm, 311- bent section, 312- connecting section, 313- flexible section, 314- S-shaped structure, 315- connecting hole, 410- first folding arm, 420- second folding arm. DETAILED DESCRIPTION

[0023] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with examples and drawings. The exemplary embodiments of the present invention and their descriptions are only used to explain the present invention and are not intended to limit the present invention.

[0024] In the following description, numerous specific details are set forth to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that these specific details are not necessarily required to practice the present invention. In other instances, well-known structures, circuits, materials, or methods are not described in detail to avoid obscuring the present invention.

[0025] Throughout this specification, references to "one embodiment," "an embodiment," "an example," or "an example" mean that a particular feature, structure, or characteristic described in connection with the embodiment or example is included in at least one embodiment of the present invention. Therefore, appearances of the phrases "one embodiment," "an embodiment," "an example," or "an example" in various places throughout this specification are not necessarily all referring to the same embodiment or example. Furthermore, the particular features, structures, or characteristics may be combined in one or more embodiments or examples in any suitable combinations and / or subcombinations. Furthermore, it will be understood by those of ordinary skill in the art that the figures provided herein are for illustrative purposes only and are not necessarily drawn to scale. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0026] In the description of the present invention, the terms "front", "back", "left", "right", "up", "down", "vertical", "horizontal", "high", "low", "inside", "outside", etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings. 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 direction, be constructed and operated in a specific direction. Therefore, they should not be understood as limiting the scope of protection of the present invention.

[0027] Example like Figure 1 and 5 As shown, this embodiment provides a valve stent 100 for mitral valve replacement, including an annular stent 100, which is made by an integrated molding process; for example, mold casting, 3D printing, laser cutting and other processes; the center of the stent 100 is used to place the valve; the upper end of the stent 100 is provided with a connecting portion 300 for connecting to a conveying device, and the lower end is provided with an anchoring portion 200, the anchoring portion 200 includes an anchoring arm 210, one end of the anchoring arm 210 is connected to the connection between the compression units 110, and the anchoring arm 210 is bendable. During the positioning process of the valve, the anchoring arm 210 bends and then rotates to hook the tendon cord. At the same time, the native valve can also be wrapped and tightened during the bending and rotation process of the anchoring arm 210, thereby effectively increasing the anchoring effect of the valve.

[0028] like Figure 1 and Figure 4 As shown, in this embodiment, one end of the anchoring arm 210 extends from between the connection points of the lower layer's circumferentially arranged folding portions 111, so that the axial length of the stent 100 is shorter after compression, facilitating surgical operations.

[0029] The anchoring arm 210 is provided with a clamping portion 220 at one end away from the stent 100. The clamping portion 220 includes a first clamping body 221 and a second clamping body 222 that are bendable. Figure 2 As shown, the first clamping body 221 and the second clamping body 222 are adapted to each other, and the first clamping body 221 and the second clamping body 222 are both V-shaped clamping bodies, and the size of the first clamping body 221 is slightly larger than the size of the second clamping body 222; when the two clamping bodies are not bent, the first clamping body 221 and the second clamping body 222 are overlapped along the thickness direction of the anchoring arm 210, which can keep the two clamping bodies and the anchoring arm 210 in the same plane and will not affect the delivery process of the valve, as shown in Figures and Figures. When not in use, one end of the first clamping body 221 and one end of the second clamping body 222 are parallel to each other and overlap up and down, and the first clamping body 221 wraps around the second clamping body 222 as a whole; when in use, the ends of the first clamping body 221 and the second clamping body 222 connected to the anchoring arm 210 are staggered from each other to form a clamping opening; and the first clamping body 221 and the second clamping body 222 have a certain width, so when contacting the mitral valve annulus or leaflets, they can be converted from line contact to surface contact, thereby increasing the buffering effect and preventing damage to the annulus or leaflets.

[0030] It should be noted that, in some other embodiments, the first clamping body 221 and the second clamping body 222 may also be configured in other shapes.

[0031] Furthermore, the anchoring arm 210 is configured with a fixing portion 230, which includes a groove and a bendable anchoring member 233 disposed in the groove. Figures 1 to 3 As shown in the figure, in this embodiment, a groove is provided on the anchoring arm 210 near the two clamping bodies, which passes through the anchoring arm 210. An anchor 233 is provided in the groove. The anchor 233 is integrally formed with the anchoring arm 210, and the portion where the anchor 233 is connected to the anchoring arm 210 can be bent. After the anchoring arm 210 is rotated and wrapped around the tendon, the sharp piercing end 234 provided on the anchor 233 will penetrate into the leaflet that is in contact with it and lock it, thereby preventing the valve from rotating back after being released and avoiding the occurrence of slippage.

[0032] Preferably, the groove includes a first through groove 231 and a second through groove 232, and the anchoring member 233 in the first through groove 231 and the anchoring member 233 in the second through groove 232 have the same bending direction; Figure 2 and Figure 3 As shown, in this embodiment, the first through groove 231 and the second through groove 232 are arranged side by side, and the bending directions of the anchoring members 233 in the first through groove 231 and the second through groove 232 are the same. After the anchoring arm 210 is rotated and wrapped around the tendon cord, the sharp piercing ends 234 provided on the two anchoring members 233 will penetrate into the leaflet that is in contact with its anchoring arm 210, and cooperate with the first clamping body 221 and the second clamping body 222 to achieve a better anchoring effect on the valve.

[0033] Preferably, the bending directions of the anchoring member 233 in the first through groove 231 and the anchoring member 233 in the second through groove 232 are opposite. Figure 2 As shown, in some other embodiments, the anchor 233 in the first through groove 231 is bent from bottom to top, and the anchor 233 in the second through groove 232 is bent from top to bottom. After the insertion end 234 penetrates the leaflet, the bending directions of the two anchors 233 are relative, which can better fix the valve and better prevent the valve from rotating after the valve is released.

[0034] It should be noted that, in some other embodiments, multiple grooves can be provided, and the specific number is not limited.

[0035] It should be noted that if Figure 2 and Figure 3 As shown, the anchoring member 233 and the anchoring arm 210 are integrally formed. In this embodiment, when the first through groove 231 and the second through groove 232 are excavated on the anchoring arm 210, the anchoring member 233 is manufactured in the groove.

[0036] Preferably, in some other embodiments, the anchoring arm 210 is arranged in a counterclockwise direction with the center of the stent 100 as a reference.

[0037] In the above embodiment, if Figure 1 As shown, multiple compression units 110 are arranged circumferentially and integrally formed into an annular mesh hollow stent 100, which makes the stent 100 more compressible and easier to compress, and correspondingly reduces the cost of processing and manufacturing. The center of the annular stent 100 is used to install the valve to be used in the operation; the anchoring portion 200 is integrally formed with the compression unit 110 and is used to fix the tendon cord. A single compression unit 110 is composed of two folding portions 111 arranged in the axial direction of the stent 100 and a connecting rod 112 for connecting the folding portions 111. The two folding portions 111 are arranged in the same direction, and the overall structure of the folding portion 111 is similar to a V-shaped structure. When the stent 100 is compressed, as shown in FIG. Figure 4 and Figure 5 As shown, the two folding portions 111 are folded in the same direction, so when the bracket 100 is folded or compressed, the multiple compression units 110 are gradually folded and compressed together, and the bracket 100 will not overlap in the wall thickness direction; both ends of the folding portion 111 are connected to the end of the connecting rod 112, and the connecting rod 112 is located between every two folding portions 111 and is also arranged along the axial direction of the bracket 100, so that when the bracket 100 is compressed, the multiple compression units 110 can be compressed to minimize the diameter of the bracket 100 according to the connecting rod 112.

[0038] It should be noted that in the above embodiment, three folding portions 111 are provided along the axial direction, so that the bracket 100 has two layers of compression units 110 in the axial direction; in other embodiments, the size and number of the compression units 110 may vary without specific limitation.

[0039] Preferably, the folding portion 111 includes a first folding arm 410 and a second folding arm 420, one end of the first folding arm 410 and one end of the second folding arm 420 are connected to each other, and the other end of the first folding arm 410 is arranged opposite to the other end of the second folding arm 420 and corresponds to the folding direction.

[0040] like Figure 1 、 Figure 4 as well as Figure 5 As shown, in this embodiment, one end of the first folding arm 410 and one end of the second folding arm 420 are connected to each other, and the other ends extend in a direction away from each other and are connected to the adjacent first folding arm 410 or the second folding arm 420. The first folding arm 410 and the second folding arm 420 are symmetrical in structure and symmetrically arranged to form a V-shaped structure. The connecting rod 112 is arranged between the connection points of the upper and lower groups of corresponding folding arms. At the same time, the connection point of the first folding arm 410 and the second folding arm 420 extends in the axial direction of the downward bracket 100; when the bracket 100 is compressed, the ends of the first folding arm 410 and the second folding arm 420 that are away from each other approach the connection point of the two connecting arms 310.

[0041] It should be noted that, in some other embodiments, the connection between the first folding arm 410 and the second folding arm 420 may also extend upward along the axial direction of the bracket 100 .

[0042] Preferably, the connecting rod 112 comprises a wave-shaped rod.

[0043] like Figure 4 As shown, the connecting rod 112 is wavy in shape, and the two ends of the wavy rod are respectively connected between the connection points of the first folding arm 410 and the second folding arm 420 arranged circumferentially in the upper layer and between the connection points of the two corresponding circumferentially arranged folding arms in the lower layer. The connecting rod 112 is set to be wavy, which can make the stent 100 have a certain flexibility when it is in a clamped state. When transported across the atrial septum, the valve stent 100 can produce better bending characteristics, thereby cooperating with the conveyor to adjust the bend, greatly increasing the passability of the valve delivery, and improving the success rate of the operation.

[0044] Preferably, the connecting portion 300 includes a bendable connecting arm 310, which is integrally formed with the compression unit 110 and is used to connect to a conveying device, such as Figure 1As shown, in this embodiment, one end of the connecting arm 310 extends from the connection between the upper, circumferentially arranged first folding arm 410 and the second folding arm 420, making the axial length of the stent 100 shorter after compression, facilitating surgical operation; the connecting arm 310 has a certain bending effect, and when the valve is positioned, the connecting arm 310 can be rotated to hook the chordae tendineae and tighten them. This effectively improves the anchoring performance of the valve. In addition, this structure can also effectively reduce paravalvular leakage and prevent outflow from obstruction.

[0045] Preferably, Figure 1 and Figure 4 As shown, the connecting arm 310 includes a curved segment 311 and a connecting segment 312 connected to each other. The cross-sectional size of the connecting segment 312 is larger than the cross-sectional size of the curved segment 311, which is used to increase the connection stability with the delivery device; the curved segment 311 is integrally extended from the stent 100, and is anchored on the left atrium side of the patient after being bent during use, and can cooperate with the anchoring arm 210 to clamp the valve ring or the atrial wall, thereby more stably fixing the valve and preventing it from shifting toward the ventricle or atrial side; the connecting segment 312 is provided with a flexible segment 313 for fitting the atrial wall. The setting of the flexible segment 313 can have better flexibility and fit, so that the connecting arm 310 has a good fit with the atrial wall, reducing the risk of paravalvular leakage.

[0046] Preferably, a connecting hole 315 is provided on the connecting arm 310, and the connecting hole 315 is used to adapt to the conveying device.

[0047] like Figure 1 and Figure 4 As shown, the connecting hole 315 is opened at the end of the connecting arm 310 away from the compression unit 110, and is used to connect and adapt to the valve delivery device. In this embodiment, the connecting hole 315 is circular. In other embodiments, the shape of the connecting hole 315 can also be set to be specifically adapted according to the delivery device.

[0048] It should be noted that in the above embodiment, the connecting arm 310 has a continuous S-shaped structure 314, as specifically shown in FIG1 . During surgery, the continuous S-shaped structure 314 can generate a certain degree of flexibility and can deform to a certain extent as the shape of the valve annulus or atrial wall changes, thereby achieving a better sealing effect and reducing damage to the valve annulus or atrial wall.

[0049] It should be noted that, in some other embodiments, the connecting arm 310 may also adopt a structure in which a plurality of diamond-shaped hollow units are arranged.

[0050] The above embodiments of the present invention focus on the differences between the various embodiments. As long as the different optimization features between the various embodiments are not contradictory, they can be combined to form a better embodiment. Considering the simplicity of the text, they will not be repeated here.

[0051] The specific implementation methods described above further illustrate the objectives, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above description is only a specific implementation method of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A valve stent for mitral valve replacement, comprising an integrally formed annular stent (100), characterized in that: An anchoring portion (200) is provided at one end of the bracket (100), and a connecting portion (300) is provided at the other end. The connecting portion (300) includes a connecting arm (310), the connecting arm (310) includes a curved section (311) and a connecting section (312) connected to each other, the curved section (311) integrally extending from the stent (100), and the connecting section (312) is provided with a flexible section (313) for fitting against the atrial wall; The anchoring portion (200) includes a bendable anchoring arm (210), and one end of the anchoring arm (210) away from the stent (100) is provided with a clamping portion (220) for anchoring the valve and a fixing portion (230) for preventing the valve from rotating.

2. The valve stent for mitral valve replacement according to claim 1, characterized in that: The flexible section (313) is provided with a continuous S-shaped structure (314).

3. The valve stent for mitral valve replacement according to claim 2, characterized in that: The connecting section (312) is provided with a connecting hole (315), and the flexible section (313) is located between the connecting hole (315) and the curved section (311).

4. The valve stent for mitral valve replacement according to claim 1, characterized in that: The clamping portion (220) includes a bendable first clamping body (221) and a second clamping body (222) that are bifurcated and extended from one end away from the stent (100). The first clamping body (221) and the second clamping body (222) are adapted to each other and are used to clamp the valve.

5. The valve stent for mitral valve replacement according to claim 4, characterized in that: The first clamping body (221) and the second clamping body (222) are arranged to overlap along the thickness direction of the anchoring arm (210).

6. The valve stent for mitral valve replacement according to claim 5, characterized in that: The first clamping body (221) and the second clamping body (222) are both configured as V-shaped clamping bodies, and one end of the V-shaped clamping body is connected to the anchoring arm (210).

7. The valve stent for mitral valve replacement according to claim 1, characterized in that: The anchoring arm (210) is arranged in a counterclockwise direction with the center of the bracket (100) as a reference.

8. The valve stent for mitral valve replacement according to claim 1, characterized in that: The fixing portion (230) comprises a groove formed in the anchoring arm (210), wherein a bendable anchoring member (233) adapted thereto is provided in the groove.

9. The valve stent for mitral valve replacement according to claim 8, characterized in that: The groove includes a first through groove (231) and a second through groove (232), The anchoring member (233) in the first through groove (231) and the anchoring member (233) in the second through groove (232) have the same bending direction; Or the bending directions of the anchoring member (233) in the first through groove (231) and the anchoring member (233) in the second through groove (232) are opposite.

10. The valve stent for mitral valve replacement according to claim 8, characterized in that: The anchoring member (233) and the anchoring arm (210) are integrally formed.

11. The valve stent for mitral valve replacement according to claim 8, characterized in that: The anchoring member (233) is provided with a piercing end (234).

12. The valve stent for mitral valve replacement according to claim 1, characterized in that: The bracket (100) is composed of a plurality of hollow compression units (110) arranged circumferentially as a whole, and the anchoring portion (200) and the connecting portion (300) are respectively located at two ends of the compression unit (110).

13. The valve stent for mitral valve replacement according to claim 12, characterized in that: The compression unit (110) includes a plurality of folding portions (111) arranged along the folding direction of the bracket (100), and connecting rods (112) are axially arranged between the plurality of folding portions (111).

14. The valve stent for mitral valve replacement according to claim 13, characterized in that: The folding portion (111) includes a first folding arm (410) and a second folding arm (420), one end of the first folding arm (410) and one end of the second folding arm (420) are connected to each other, and the other end of the first folding arm (410) and the other end of the second folding arm (420) are arranged opposite to each other and correspond to the folding direction.

15. The mitral valve replacement stent according to claim 13, characterized in that: The connecting rod (112) comprises a wave-shaped rod.

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