A valve holder for mitral valve replacement

Abstract

The application relates to the technical field of medical devices, in particular to a valve support for mitral valve replacement, which comprises an annular support formed integrally, one end of the support is provided with an anchoring part, and the other end is 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 to each other, the bending section is integrally extended from the support, and the connecting section is provided with a flexible section used for abutting against the atrial wall; the anchoring part comprises a bendable anchoring arm, one end of the anchoring arm away from the support 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 beneficial effects that the anchoring performance of the valve support is enhanced, and the risk of paravalvular leakage is reduced.

Description

TECHNICAL FIELD

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

[0002] With the intensification 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 techniques 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 of the patient through the delivery device, but in the operation process, it usually faces the problems of poor anchoring effect and damage to the native leaflet or chordae tendineae during the anchoring process, thereby causing valve displacement, paravalvular leakage and the like, so the prior art still needs to be improved. SUMMARY

[0004] The purpose of the present application is to provide a valve stent for mitral valve replacement, 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:

[0006] A valve stent for mitral valve replacement, comprising a ring-shaped stent formed integrally, one end of the stent being provided with an anchoring portion, and the other end being provided with a connecting portion;

[0007] The connecting portion comprises a connecting arm, the connecting arm comprising a curved segment and a connecting segment connected to each other, the curved segment being integrally extended from the stent, and the connecting segment being provided with a flexible segment for abutting against the atrial wall;

[0008] The anchoring portion comprises a bendable anchoring arm, one end of the anchoring arm away from the stent being provided with a clamping portion for anchoring the valve, and a fixing portion for preventing the valve from rotating.

[0009] Preferably, the flexible segment is provided with a continuous S-shaped structure.

[0010] Preferably, the connecting segment is provided with a connecting hole, and the flexible segment is located between the connecting hole and the curved segment.

[0011] Preferably, the clamping portion comprises a bendable first clamping body and a second clamping body bifurcated and extended from one end away from the stent, the first clamping body and the second clamping body being adapted to each other and used for clamping the valve.

[0012] Preferably, the first clamping body and the second clamping body are arranged in overlapping along the thickness direction of the anchoring arm.

[0013] Preferably, the first clamping body and the second clamping body are both arranged as V-shaped clamping bodies, one end of the V-shaped clamping body is connected with the anchoring arm.

[0014] Preferably, the connecting arm is arranged in a counterclockwise direction with the center of the stent as a reference.

[0015] Preferably, the fixing part comprises a groove arranged on the anchoring arm, and a bendable anchoring part is arranged in the groove.

[0016] Preferably, the groove comprises a first through groove and a second through groove,

[0017] The bending direction of the anchoring part in the first through groove is the same as that of the anchoring part in the second through groove;

[0018] Or the bending direction of the anchoring part in the first through groove is opposite to that of the anchoring part in the second through groove.

[0019] Preferably, the anchoring part is integrally formed with the anchoring arm.

[0020] Preferably, the anchoring part is provided with a piercing end.

[0021] Preferably, the stent is integrally composed of a plurality of hollow compression units arranged circumferentially, and the anchoring part and the connecting part are respectively located at two ends of the compression unit.

[0022] Preferably, the compression unit comprises a plurality of folding parts arranged in the folding direction of the stent, and a connecting rod is arranged between the plurality of folding parts in the axial direction.

[0023] Preferably, the folding part comprises a first folding arm and a second folding arm, one end of the first folding arm and one end of the second folding arm are connected with each other, the other end of the first folding arm and the other end of the second folding arm are arranged opposite to each other and correspond to the folding direction.

[0024] Preferably, the connecting rod comprises a wave-shaped rod.

[0025] Compared with the prior art, the present application has the following advantages and beneficial effects:

[0026] 1. The stent in the technical solution is manufactured by an integral molding process, so that the compressibility of the stent is greater, thereby being more easily compressed, and the manufacturing cost is also reduced accordingly.

[0027] 2. The connecting arm has a bendable effect, which can be bent during the positioning of the valve, and can be used in cooperation with the anchoring part to clamp the annulus or the atrial wall of the patient, thereby more stably fixing the valve and preventing the valve from shifting to the ventricle or atrium side, thereby effectively increasing the anchoring effect on the valve.

[0028] 3. The anchoring arm has a bendable effect, during the positioning of the valve, bending can occur, and then the rotating hooking of the chordae tendineae, while the bending and rotating of the anchoring arm also winds up the valve, thus effectively increasing the anchoring effect on the valve. BRIEF DESCRIPTION OF DRAWINGS

[0029] The drawings described herein are intended to provide further understanding of the embodiments of the present application, form a part of the specification, and do not constitute a limitation on the embodiments of the present application. In the drawings:

[0030] Figure 1 A structural schematic diagram of a valve support for mitral valve replacement is provided for the embodiments of the present application;

[0031] Figure 2 A partial enlarged schematic diagram of A in the figure;

[0032] Figure 3 A schematic diagram of another setting mode of the anchoring member is provided for the embodiments of the present application;

[0033] Figure 4 A partial schematic diagram of a valve support for mitral valve replacement after being laid flat for the embodiments of the present application;

[0034] Figure 5 A structural schematic diagram of a valve support for mitral valve replacement after being compressed for the embodiments of the present application.

[0035] Markings in the drawings and corresponding names of parts:

[0036] 100 - support, 110 - compression unit, 111 - folding part, 112 - connecting rod, 200 - anchoring part, 210 - anchoring arm, 220 - clamping part, 221 - first clamping body, 222 - second clamping body, 230 - fixing part, 231 - first through slot, 232 - second through slot, 233 - anchoring member, 234 - piercing end, 300 - connecting part, 310 - connecting arm, 311 - bending section, 312 - connecting section, 313 - flexible section, 314 - S-shaped structure, 315 - connecting hole, 410 - first folding arm, 420 - second folding arm. DETAILED DESCRIPTION

[0037] In order to make the purpose, technical scheme and advantages of the present application more clear and obvious, the present application will be further described in detail below in combination with embodiments and drawings, the illustrative embodiments of the present application and the description thereof are only used to explain the present application, and do not constitute a limitation on the present application.

[0038] In the following description, numerous specific details are set forth to provide a thorough understanding of the present application. However, it will be apparent to one skilled in the art that the present application can be practiced without the specific details. In other instances, well-known structures, circuits, materials or the like have not been described in order to avoid obscuring the present application.

[0039] Reference throughout this specification to "one embodiment", "an embodiment", "one example", or "an example" means that a particular feature, structure, or characteristic described in connection with the embodiment or example is included in at least one embodiment of the application. Thus, the appearances of the phrases "in one embodiment", "in an embodiment", "in one example", or "in 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 can be combined in any suitable

[0040] In the description of the present application, the terms "front", "back", "left", "right", "top", "bottom", "vertical", "horizontal", "high", "low", "inner", "outer", and the like, indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, only for the convenience of describing the present application and simplifying the description, and do not indicate or imply 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 limiting the scope of protection of the present application.

[0041] Embodiment

[0042] As shown in Figure 1 and 5 In this embodiment, a valve support 100 for mitral valve replacement is provided, which includes an annular support 100 made by an integrated process; for example, mold casting, 3D printing, laser cutting process; the center of the support 100 is used to place the valve; the upper end of the support 100 is provided with a connecting part 300 for connecting the conveying device, and the lower end is provided with an anchoring part 200, the anchoring part 200 includes an anchoring arm 210, one end of the anchoring arm 210 is connected to the connecting part between the compression units 110, the anchoring arm 210 is bendable, in the positioning process of the valve, the anchoring arm 210 is bent, then rotates to hook the chordae tendineae, and at the same time, the original valve is also wound and tightened in the bending and rotating process of the anchoring arm 210, so as to effectively increase the anchoring effect on the valve.

[0043] As shown in Figure 1 and Figure 4As shown, in the present embodiment, one end of the anchoring arm 210 is connected by the lower layer, circumferentially arranged folding part 111 between the connecting parts, so that the length of the stent 100 in the axial direction is shorter after compression, facilitating the surgical operation.

[0044] The end of the anchoring arm 210 away from the stent 100 is configured with a clamping part 220, which includes a bendable first clamping body 221 and a second clamping body 222, as shown in Figure 2 As shown, the first clamping body 221 and the second clamping body 222 are adapted to each other, both of which are V-shaped clamping bodies, and the size of the first clamping body 221 is slightly larger than that 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 arranged in the thickness direction of the anchoring arm 210, so that the two clamping bodies remain in a plane with the anchoring arm 210, without affecting the delivery process of the valve, as shown in the figures. In the unused 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 each other, and the first clamping body 221 wraps the second clamping body 222 as a whole; in the use state, the ends of the first clamping body 221 and the second clamping body 222 connected to the anchoring arm 210 are staggered, thereby forming a clamping opening; and the first clamping body 221 and the second clamping body 222 have a certain width, so that when contacting the mitral annulus or the valve leaflet, the line contact can be converted to the surface contact, increasing the buffering effect and preventing damage to the annulus or the valve leaflet.

[0045] It should be noted that in other embodiments, the first clamping body 221 and the second clamping body 222 can also be arranged in other shapes.

[0046] Further, the anchoring arm 210 is configured with a fixing part 230, which includes a groove and a bendable anchoring part 233 arranged in the groove, as shown in Figures 1 to 3 As shown in the figure, in the present embodiment, a groove penetrating the anchoring arm 210 is provided on the anchoring arm 210 near the two clamping bodies, and the anchoring part 233 is arranged in the groove, the anchoring part 233 is integrally formed with the anchoring arm 210, and the part of the anchoring part 233 connected to the anchoring arm 210 can be bent, after the anchoring arm 210 is rotated and wound around the chordae tendineae, the sharp piercing end 234 arranged on the anchoring part 233 will pierce into the valve leaflet attached thereto, and be locked, thereby preventing the valve from rotating and releasing, and avoiding the occurrence of slippage.

[0047] Preferably, the groove includes a first through groove 231 and a second through groove 232, the anchoring part 233 in the first through groove 231 and the anchoring part 233 in the second through groove 232 have the same bending direction; as shown in Figure 2 and Figure 3As shown, in the embodiment, the first through groove 231 and the second through groove 232 are arranged side by side, and the bending directions of the anchor members 233 in the first through groove 231 and the second through groove 232 are the same. After the anchor arms 210 are rotated to wind the chordae tendineae, the sharp piercing ends 234 arranged on the two anchor members 233 pierce into the leaflets that are combined with the anchor arms 210, and cooperate with the first clamping body 221 and the second clamping body 222 to achieve better anchoring effect on the valve.

[0048] Preferably, the bending directions of the anchor members 233 in the first through groove 231 and the second through groove 232 are opposite. Figure 2 As shown, in other embodiments, the anchor members 233 in the first through groove 231 are bent from bottom to top, and the anchor members 233 in the second through groove 232 are bent from top to bottom. After the piercing ends 234 pierce into the leaflets, because the bending directions of the two anchor members 233 are opposite, better fixing effect on the valve can be achieved, and the device can better prevent rotation after the valve is released.

[0049] It should be noted that in other embodiments, a plurality of grooves can be arranged, and the specific number is not limited.

[0050] It should be noted that, as shown in Figure 2 and Figure 3 As shown, the anchor members 233 are integrally formed with the anchor arms 210; in the embodiment, the anchor members 233 are manufactured in the grooves at the same time when the first through groove 231 and the second through groove 232 are excavated on the anchor arms 210.

[0051] Preferably, in other embodiments, the anchor arms 210 are arranged in the counterclockwise direction with the center of the stent 100 as the reference.

[0052] In the above embodiment, as shown in Figure 1 As shown, the plurality of compression units 110 are arranged in the circumferential direction and integrally formed into a ring-shaped mesh-shaped hollow stent 100, so that the compressibility of the stent 100 is larger, and the stent 100 is more easily compressed, and the manufacturing cost is also reduced. The center of the ring-shaped stent 100 is used to install the valve to be used in surgery; the anchor portion 200 is integrally formed with the compression unit 110 and is used to fix the chordae tendineae. Each compression unit 110 is composed of two folding portions 111 arranged in the axial direction of the stent 100 and a connecting rod 112 used to connect 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 Figure 4 and Figure 5As shown, the two folding portions 111 are folded in the same direction, so that when the stent 100 is folded or compressed, the plurality of compression units 110 are gradually folded and compressed together, and the stent 100 does not overlap in the wall thickness direction; the two ends of the folding portion 111 are connected with the end of the connecting rod 112, and the connecting rod 112 is located between every two folding portions 111 and is arranged in the axial direction of the stent 100, so that when the stent 100 is compressed, the plurality of compression units 110 can minimize the diameter of the compressed stent 100 through the connecting rod 112.

[0053] It should be noted that in the above embodiment, three folding portions 111 are arranged in the axial direction, so that there are two layers of compression units 110 in the axial direction of the stent 100; in other embodiments, the size and number of the compression units 110 can be changed and are not specifically limited.

[0054] Preferably, the folding portion 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 with 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.

[0055] As shown in Figure 1 , Figure 4 and Figure 5 , in the present embodiment, one end of the first folding arm 410 and one end of the second folding arm 420 are connected with each other, and the other end extends away from each other and is connected with 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, and the connecting rod 112 is arranged between the connection positions of the upper and lower groups of corresponding folding arms, and at the same time, the connection positions of the first folding arm 410 and the second folding arm 420 extend downward along the axial 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 connection position of the two connecting arms 310.

[0056] It should be noted that in some other embodiments, the connection positions of the first folding arm 410 and the second folding arm 420 can also extend upward along the axial direction of the stent 100.

[0057] Preferably, the connecting rod 112 comprises a wave-shaped rod.

[0058] As shown in Figure 4As shown, the connecting rod 112 is in a wavy shape, and the two ends of the wavy rod are connected between the connecting places of the circumferentially arranged first and second folding arms 410 and 420 on the upper layer and the corresponding circumferentially arranged two folding arms on the lower layer. The wavy shape of the connecting rod 112 can make the stent 100 have a certain flexibility when it is in the compressed state, and the valve stent 100 can have better bending characteristics when it is delivered through the interatrial septum, so as to be adjusted in bending by the delivery device, greatly increasing the passability of the valve delivery and improving the success rate of the operation.

[0059] Preferably, the connecting part 300 comprises a bendable connecting arm 310 which is integrally formed with the compression unit 110 and is used for connecting the delivery device, such as Figure 1 As shown, in the embodiment, one end of the connecting arm 310 extends from between the connecting places of the circumferentially arranged first and second folding arms 410 and 420 on the upper layer, so that the length of the stent 100 in the axial direction is shorter after being compressed, facilitating the 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 and wind the chordae tendineae, thereby effectively increasing the anchoring performance of the valve. In addition, the structure can also effectively reduce the paravalvular leakage and prevent the outflow to the obstruction.

[0060] Preferably, as shown in Figure 1 and Figure 4 The connecting arm 310 comprises a bending section 311 and a connecting section 312 which are connected to each other, and the cross-sectional size of the connecting section 312 is larger than that of the bending section 311, so as to increase the connection stability with the delivery device. The bending section 311 is integrally extended from the stent 100 and is anchored to the left atrium side of the patient after being bent in use, and cooperates with the anchoring arm 210 to clamp the annulus or the atrial wall, thereby more stably fixing the valve and preventing it from moving to the ventricle or atrium side. The connecting section 312 is provided with a flexible section 313 for abutting against the atrial wall. The flexible section 313 can have better flexibility and abutting property, so that the connecting arm 310 has a good abutting with the atrial wall and reduces the risk of paravalvular leakage.

[0061] Preferably, the connecting arm 310 is provided with a connecting hole 315 which is used for adapting to the delivery device.

[0062] As shown in Figure 1 and Figure 4 The connecting hole 315 is arranged at the end of the connecting arm 310 away from the compression unit 110 and is used for adapting to the delivery device of the valve. In the embodiment, the connecting hole 315 is in a circular shape, and in other embodiments, the shape of the connecting hole 315 can be set according to the delivery device.

[0063] It should be noted that in the above embodiment, the connecting arm 310 adopts a continuous S-shaped structure 314, as shown in FIG. 1. In surgery, the continuous S-shaped structure 314 can produce a certain flexibility, can change a certain deformation along with the shape change of the annulus or atrial wall, thereby producing a better sealing effect, and can reduce the damage to the annulus or atrium.

[0064] It should be noted that in other embodiments, the connecting arm 310 can also adopt a structure arranged with multiple diamond-shaped hollow units.

[0065] The above embodiment of the present application focuses on the differences between the various embodiments. The different optimization features between the various embodiments can be combined to form a more optimal embodiment without contradiction. In view of the brevity of the text, it will not be repeated here.

[0066] The above specific embodiments further illustrate the purpose, technical solutions and beneficial effects of the present application. It should be understood that the above description is only a specific embodiment of the present application and is not used to limit the protection scope of the present application. Any modification, equivalent replacement, improvement, etc. within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A valve stent for mitral valve replacement, comprising a ring-shaped stent (100) which is integrally formed, characterized in that, The upper end of the support (100) is provided with a connecting part (300), and the lower end is provided with an anchoring part (200); The connecting part (300) comprises a connecting arm (310), the connecting arm (310) comprises a bending segment (311) and a connecting segment (312) connected to each other, the bending segment (311) is integrally extended from the support (100), the connecting segment (312) is provided with a flexible segment (313) for abutting the atrial wall, the flexible segment (313) is provided with a continuous S-shaped structure (314), the connecting segment (312) is provided with a connecting hole (315), and the flexible segment (313) is located between the connecting hole (315) and the bending segment (311). The anchoring part (200) comprises a bendable anchoring arm (210), one end of the anchoring arm (210) away from the support (100) is provided with a clamping part (220) for anchoring the valve, and a fixing part (230) for preventing the valve from rotating.

2. The valve stent for mitral valve replacement of claim 1, wherein, The clamping part (220) comprises a bendable first clamping body (221) and a second clamping body (222) bifurcated and extended from one end away from the support (100), the first clamping body (221) and the second clamping body (222) are matched with each other and used for clamping the valve.

3. The valve stent for mitral valve replacement of claim 2, wherein, The first clamping body (221) and the second clamping body (222) are arranged in overlapping manner along the thickness direction of the anchoring arm (210).

4. The valve stent for mitral valve replacement of claim 3, wherein, The first clamping body (221) and the second clamping body (222) are both provided as V-shaped clamping bodies, one end of the V-shaped clamping body is connected with the anchoring arm (210).

5. The valve stent for mitral valve replacement of claim 1, wherein, The anchoring arm (210) is deviated in counterclockwise direction with the center of the support (100) as the reference.

6. The valve stent for mitral valve replacement of claim 1, wherein, The fixing part (230) comprises a groove opened in the anchoring arm (210), and a bendable anchoring piece (233) matched with the groove is arranged in the groove.

7. The valve stent for mitral valve replacement of claim 6, wherein, The groove comprises a first through groove (231) and a second through groove (232), The bending direction of the anchoring piece (233) in the first through groove (231) is the same as that of the anchoring piece (233) in the second through groove (232); Or the bending direction of the anchoring piece (233) in the first through groove (231) is opposite to that of the anchoring piece (233) in the second through groove (232).

8. The valve stent for mitral valve replacement of claim 6, wherein, The anchoring piece (233) is integrally formed with the anchoring arm (210).

9. The valve stent for mitral valve replacement of claim 6, wherein, The anchoring piece (233) is provided with a piercing end (234).

10. The valve stent for mitral valve replacement of claim 1, wherein, The support (100) is integrally composed of a plurality of hollow compression units (110) arranged circumferentially, and the anchoring part (200) and the connecting part (300) are respectively located at two ends of the compression unit (110).

11. The valve stent for mitral valve replacement of claim 10, wherein, The compression unit (110) comprises a plurality of folding parts (111) arranged in the folding direction of the support (100), and a connecting rod (112) is arranged between the plurality of folding parts (111) in the axial direction.

12. The valve stent for mitral valve replacement of claim 11, wherein, 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) is arranged opposite to the other end of the second folding arm (420) and corresponds to a folding direction.

13. The valve stent for mitral valve replacement of claim 11, wherein, The connecting rod (112) comprises a wave-shaped rod.

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