Valve stent for mitral valve replacement

Abstract

The invention relates to the technical field of medical instruments, in particular to a mitral valve replacement valve stent which comprises an integrally-formed annular stent body, an anchoring part is arranged at one end of the stent body in an extending mode and comprises a bendable anchoring arm, and a clamping part used for anchoring a valve is arranged at the end, away from the stent body, of the anchoring arm. And a fixing part for preventing the valve from rotating. The method has the beneficial effects that the anchoring performance of the valve is enhanced, and the perivalvular leakage risk is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a mitral valve replacement valve stent. BACKGROUND

[0002] With the aggravation of global population aging, the incidence of heart valve disease is also increasing year by year. As one of the common heart valve diseases, the treatment demand of mitral valve is increasing. The development of minimally invasive technology such as transcatheter mitral valve replacement (TMVR) provides a new choice for mitral valve replacement. Although these minimally invasive surgeries have the advantages of small trauma and rapid recovery, there are still some significant shortcomings and challenges.

[0003] The transfemoral mitral valve is released in the body through a delivery device, but during the operation, it usually faces the problems of poor anchoring effect and damage to the native leaflet or chordae during the anchoring process, resulting in valve displacement, paravalvular leakage and other conditions. Therefore, the prior art still needs to be improved. SUMMARY

[0004] The purpose of the present application is to provide a mitral valve replacement valve stent, which aims to solve the problem of poor anchoring effect of the valve in the prior art, effectively increase the anchoring performance of the valve during the operation process, and improve the sealing effect, thereby reducing the risk of paravalvular leakage.

[0005] The present application is realized by the following technical scheme: A mitral valve replacement valve stent comprises an annular stent formed integrally, an anchoring portion is provided at one end of the stent, the anchoring portion comprises a bendable anchoring arm, a clamping portion for anchoring the valve is provided at the end of the anchoring arm away from the stent, and a fixing portion for preventing the valve from rotating is provided.

[0006] Preferably, the clamping portion comprises a bendable first clamping body and a second clamping body which extend out from the end of the stent away from the stent, and the first clamping body and the second clamping body are adapted to each other and used for clamping the valve.

[0007] Preferably, the first clamping body and the second clamping body are arranged in overlapping manner along the thickness direction of the anchoring arm.

[0008] Preferably, the first clamping body and the second clamping body are both provided as V-shaped clamping bodies, and one end of the V-shaped clamping body is connected with the anchoring arm.

[0009] Preferably, the anchoring arm is arranged in counterclockwise direction with the center of the stent as the reference.

[0010] Preferably, the fixing portion comprises a groove provided in the anchoring arm, and a bendable anchoring member is arranged in the groove.

[0011] Preferably, the groove comprises 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.

[0012] Preferably, the anchoring member and the anchoring arm are integrally formed.

[0013] Preferably, the anchor is provided with a piercing end.

[0014] 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.

[0015] 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.

[0016] 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.

[0017] Preferably, it further includes a connecting portion, which is located at the other end of the bracket. The connecting portion includes a bendable connecting arm, and the connecting arm is integrally formed with the bracket.

[0018] 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 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 valve is also wrapped and tightened during the bending and rotation process of the anchoring arm.

[0019] 3. The setting of the clamping part and the fixing part ensures that when the anchoring arm contacts the mitral valve annulus or leaflet, the clamping part and the leaflet are in surface contact, which increases the contact area and can play a certain buffering role, thereby preventing damage to the valve annulus or leaflet; at the same time, the fixing part can fix the valve after the valve is released to prevent it from rotating, effectively increasing the anchoring effect of the valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] 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 mitral valve replacement stent 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 mitral valve replacement stent provided by an embodiment of the present invention after being flattened and unfolded; Figure 5 A schematic diagram of the compressed structure of a mitral valve replacement stent provided by an embodiment of the present invention; 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

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] Example like Figure 1 and 5 As shown, this embodiment provides a mitral valve replacement valve stent 100, including an annular stent 100, which is made by an integrated molding process, such as 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, and 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.

[0026] 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.

[0027] 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, so that the two clamping bodies and the anchoring arm 210 are kept in the same plane, which will not affect the delivery process of the valve. Figure 5 and Figure 1In the folded state, one end of the first clamping body 221 and one end of the second clamping body 222 are parallel to each other and overlap vertically, with the first clamping body 221 completely surrounding the second clamping body 222. In the unfolded state, the ends of the first clamping body 221 and the second clamping body 222 connected to the anchoring arm 210 are staggered to form a clamping opening. The first clamping body 221 and the second clamping body 222 have a certain width, so when contacting the mitral valve annulus or leaflets, the contact can be converted from line contact to surface contact, thereby increasing the cushioning effect and preventing damage to the annulus or leaflets.

[0028] 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.

[0029] Preferably, further, the anchoring arm 210 is configured with a fixing portion 230, and the fixing portion 230 includes a groove and a bendable anchoring member 233 disposed in the groove, such as 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.

[0030] 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.

[0031] 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 2As 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.

[0032] It should be noted that, in some other embodiments, multiple grooves can be provided, and the specific number is not limited.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] Preferably, the folding part 111 comprises 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.

[0038] As shown in Figure 1 , Figure 4 and Figure 5 , in the 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 end extends away from each other and is connected to the adjacent first folding arm 410 or second folding arm 420, the first folding arm 410 and the second folding arm 420 are symmetrically structured and arranged to form a V-shaped structure, the connecting rod 112 is arranged between the connecting positions of the corresponding folding arms of the upper and lower groups, and at the same time, the connecting positions of the first folding arm 410 and the second folding arm 420 extend downward along the axis direction of the stent 100; when the stent 100 is compressed, the ends of the first folding arm 410 and the second folding arm 420 away from each other move closer to the connecting position of the two connecting arms 310.

[0039] It should be noted that in other embodiments, the connecting positions of the first folding arm 410 and the second folding arm 420 can also extend upward along the axis direction of the stent 100.

[0040] Preferably, the connecting rod 112 comprises a wave-shaped rod.

[0041] As shown in Figure 4 , the connecting rod 112 is in the shape of a wave, and the two ends of the wave-shaped rod are respectively connected between the connecting positions of the circumferentially arranged first folding arm 410 and second folding arm 420 on the upper layer and the corresponding circumferentially arranged two folding arms on the lower layer, the connecting rod 112 is arranged in a wave shape, which can make the stent 100 have a certain flexibility when it is in a compressed state, and the valve stent 100 can have better bending characteristics when it is transported through the interatrial septum, thereby cooperating with the bending device to adjust the bending, greatly increasing the passability of the valve transport and improving the success rate of the operation.

[0042] Preferably, the connecting part 300 comprises a bendable connecting arm 310, the connecting arm 310 is integrally formed with the compression unit 110 and is used to connect the delivery 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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 mitral valve replacement stent, characterized in that: The invention comprises an integrally formed annular bracket (100), one end of which is provided with an anchoring portion (200). 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 mitral valve replacement stent 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.

3. The mitral valve replacement stent according to claim 2, 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).

4. The mitral valve replacement stent according to claim 3, 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).

5. The mitral valve replacement stent 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.

6. The mitral valve replacement stent 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.

7. The mitral valve replacement stent according to claim 6, 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.

8. The mitral valve replacement stent according to claim 7, characterized in that: The anchoring member (233) and the anchoring arm (210) are integrally formed.

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

10. The mitral valve replacement stent 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).

11. The mitral valve replacement stent according to claim 10, 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).

12. The mitral valve replacement stent according to claim 11, 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.

13. The mitral valve replacement stent according to claim 1, characterized in that: It also includes a connecting portion (300), the connecting portion (300) is located at the other end of the bracket (100), the connecting portion (300) includes a bendable connecting arm (310), and the connecting arm (310) is integrally formed with the bracket (100).

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