A mitral valve replacement valve stent

Abstract

The application relates to the technical field of medical devices, in particular to a mitral valve replacement valve support which comprises an annular support formed integrally, one end of the support is provided with an anchoring part, the anchoring part comprises a bendable anchoring arm, the anchoring arm is provided with a clamping part for anchoring a valve at the end away from the support, and a fixing part for preventing the valve from rotating. The beneficial effect is that the anchoring performance of the valve 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 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:

[0006] 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.

[0007] 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.

[0008] Preferably, the first clamping body and the second clamping body are arranged in overlapping manner along the thickness direction of the anchoring arm.

[0009] Preferably, the first clamping body and the second clamping body are both arranged as V-shaped clamping bodies, and one end of the V-shaped clamping body is connected with the anchoring arm.

[0010] Preferably, the anchoring arm is arranged in counterclockwise direction with the center of the stent as the reference.

[0011] Preferably, the fixing portion comprises a groove provided in the anchoring arm, and a bendable anchoring member is arranged in the groove.

[0012] Preferably, the groove comprises a first through groove and a second through groove,

[0013] The bending direction of the anchor in the first through groove is the same as that of the anchor in the second through groove.

[0014] Or the bending direction of the anchor in the first through groove is opposite to that of the anchor in the second through groove.

[0015] Preferably, the anchor is integrally formed with the anchor arm.

[0016] Preferably, the anchor is provided with a piercing end.

[0017] Preferably, the stent is integrally formed by circumferentially arranging a plurality of hollow compression units, and the anchor portion and the connecting portion are respectively located at two ends of the compression unit.

[0018] Preferably, the compression unit comprises a plurality of folding portions arranged in the folding direction of the stent, and a connecting rod is arranged between the plurality of folding portions in the axial direction.

[0019] Preferably, the folding portion 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 to each other, and the other end of the first folding arm and the other end of the second folding arm are oppositely arranged and correspond to the folding direction.

[0020] Preferably, it further comprises a connecting portion located at the other end of the stent, and the connecting portion comprises a bendable connecting arm integrally formed with the stent.

[0021] Compared with the prior art, the present application has the following advantages and beneficial effects:

[0022] 1. The stent in the technical solution is manufactured by an integral forming process, so that the compressibility of the stent is greater, thereby being more easily compressed, and the manufacturing cost is also correspondingly reduced.

[0023] 2. The anchor arm has a bendable effect, can be bent during positioning of the valve, and then rotated to hook the chordae tendineae, and also winds and tightens the valve during the bending and rotating of the anchor arm.

[0024] 3. The arrangement of the clamping portion and the fixing portion makes the anchor arm contact the mitral valve annulus or leaflet when the clamping portion contacts the leaflet, which is surface contact, increases the contact area and can play a certain buffering role, thereby preventing damage to the annulus or leaflet; at the same time, the fixing portion can fix the valve after the valve is released, preventing it from rotating, effectively increasing the anchoring effect on the valve. BRIEF DESCRIPTION OF DRAWINGS

[0025] The drawings described herein are intended to provide further understanding of the embodiments of the present application, form a part of the specification, and are not intended to constitute limitations of the embodiments of the present application. In the drawings:

[0026] Figure 1 A structure schematic diagram of a mitral valve replacement valve stent provided by the embodiments of the present application;

[0027] Figure 2 A local enlarged schematic diagram of A in the figure;

[0028] Figure 3 A setting mode schematic diagram of another anchor provided by the embodiments of the present application;

[0029] Figure 4 A local schematic diagram of a mitral valve replacement valve stent provided by the embodiments of the present application after being laid flat and unfolded;

[0030] Figure 5 A structure schematic diagram of a mitral valve replacement valve stent provided by the embodiments of the present application after being compressed;

[0031] Markings in the drawings and corresponding component names:

[0032] 100-stent, 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-anchor, 234-piercing end, 300-connecting part, 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

[0033] In order to make the objects, technical solutions and advantages of the present application clearer, further detailed description will be made to the present application 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 limitations of the present application.

[0034] In the following description, a large number of specific details are set forth in order to provide a thorough understanding of the present application. However, it will be apparent to one of ordinary skill in the art that the present application can be practiced without these specific details. In other instances, well-known structures, circuits, materials or methods have not been described in detail in order to avoid obscuring the present application.

[0035] Reference throughout this specification to "one embodiment", "an embodiment", "one design", or "a design" means that a particular feature, structure, or characteristic described in connection with the embodiment or design is included in at least one embodiment of the application. Thus, appearances of the phrases "one embodiment", "an embodiment", "one design", or "a design" in various places throughout this specification are not necessarily all referring to the same embodiment or design. Furthermore, the particular features, structures, or characteristics can be combined in any suitable

[0036] In the description of the 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 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 application.

[0037] Embodiment

[0038] As shown in Figure 1 and 5 , in this embodiment, a mitral valve replacement valve stent 100 is provided, which includes an annular stent 100, which is made by an integral forming process, such as mold casting, 3D printing, laser cutting, etc. The center of the stent 100 is used to place the valve. The upper end of the stent 100 is provided with a connecting part 300 for connecting the delivery device, and the lower end is provided with an anchoring part 200, which includes an anchoring arm 210, one end of which is connected to the connecting part between the compression units 110. The anchoring arm 210 is bendable, and during the positioning of the valve, the anchoring arm 210 is bent and then rotated to hook the chordae tendineae, and at the same time, the original valve is also wound and tightened during the bending and rotating of the anchoring arm 210, thus effectively increasing the anchoring effect on the valve.

[0039] As shown in Figure 1 and Figure 4 , in this embodiment, one end of the anchoring arm 210 is connected between the lower layer of the circumferentially arranged folding parts 111, so that the length of the stent 100 in the axial direction is shorter after compression, facilitating surgical operation.

[0040] The end of the anchoring arm 210 away from the stent 100 is configured with a clamping portion 220, which comprises a first clamping body 221 and a second clamping body 222, as shown in Figure 2 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 overlapping along the thickness direction of the anchoring arm 210, so that the two clamping bodies and the anchoring arm 210 are kept in a plane, which will not affect the delivery process of the valve, as shown in Figure 5 and Figure 1 When folded, 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; when unfolded, the ends of the first clamping body 221 and the second clamping body 222 connected to the anchoring arm 210 are staggered with each other, thereby forming a clamping opening; and the first clamping body 221 and the second clamping body 222 have a certain width, so 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.

[0041] 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.

[0042] Preferably, further, the anchoring arm 210 is configured with a fixing portion 230, which comprises a recess and a bendable anchoring piece 233 arranged in the recess, as shown in Figures 1 to 3 In the present embodiment, a recess is formed on the anchoring arm 210 near the two clamping bodies, the recess is provided with the anchoring piece 233, the anchoring piece 233 is integrally formed with the anchoring arm 210, and the part of the anchoring piece 233 connected to the anchoring arm 210 can be bent; after the anchoring arm 210 is rotated to wind the chordae tendineae, the sharp piercing end 234 arranged on the anchoring piece 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 the sliding phenomenon.

[0043] Preferably, the recess comprises a first through slot 231 and a second through slot 232, the anchoring piece 233 in the first through slot 231 and the anchoring piece 233 in the second through slot 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 can pierce into the leaflets 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.

[0044] 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, due to the opposite bending directions of the two anchor members 233, better fixing effect on the valve can be achieved, and the rotation of the device after the valve is released can be better prevented.

[0045] It should be noted that in other embodiments, a plurality of grooves can be provided, and the specific number is not limited.

[0046] It should be noted that, as shown in Figure 2 and Figure 3 As shown, the anchor members 233 and the anchor arms 210 are integrally formed; 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.

[0047] Preferably, in other embodiments, the anchor arms 210 are arranged in the counterclockwise direction with the center of the stent 100 as the reference.

[0048] In the above embodiment, as shown in Figure 1 As shown, the plurality of compression units 110 are arranged circumferentially and integrally formed into a ring-shaped meshed 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] Preferably, the connecting rod 112 comprises a wave-shaped rod.

[0054] 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.

[0055] 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 compression, 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.

[0056] 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 bending 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 atrial 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.

[0057] Preferably, the connecting arm 310 is provided with a connecting hole 315 which is used for adapting to the delivery device.

[0058] 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.

[0059] 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.

[0060] It should be noted that in other embodiments, the connecting arm 310 can also adopt a structure arranged with a plurality of diamond-shaped hollow units.

[0061] 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.

[0062] 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 mitral valve replacement valve stent, characterized by, The application relates to a support (100) for a valve, comprising an annular support (100) formed integrally, one end of the support (100) being provided with an anchoring portion (200), The anchoring portion (200) comprises a bendable anchoring arm (210), the anchoring arm (210) being provided with a clamping portion (220) for anchoring the valve and a fixing portion (230) for preventing the valve from rotating at one end away from the support (100), The clamping portion (220) comprises bendable first and second clamping bodies (221 and 222) which are bifurcated and extend away from one end of the support (100), and the first and second clamping bodies (221 and 222) are adapted to each other and used for clamping the valve. The fixing portion (230) comprises a groove provided in the anchoring arm (210), and the groove is provided with a bendable anchoring member (233) which is adapted to the groove.

2. The mitral replacement valve stent of claim 1, wherein, The first and second clamping bodies (221 and 222) are arranged in overlapping relation along the thickness direction of the anchoring arm (210).

3. The mitral replacement valve stent of claim 2, wherein, The first and second clamping bodies (221 and 222) are both arranged as V-shaped clamping bodies, and one end of the V-shaped clamping bodies is connected with the anchoring arm (210).

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

5. The mitral replacement valve stent of claim 1, wherein, The groove comprises first and second through grooves (231 and 232), The bend direction of the anchoring member (233) in the first through groove (231) is the same as that of the anchoring member (233) in the second through groove (232); Or the bend direction of the anchoring member (233) in the first through groove (231) is opposite to that of the anchoring member (233) in the second through groove (232).

6. The mitral replacement valve stent of claim 5, wherein, The anchoring member (233) is formed integrally with the anchoring arm (210).

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

8. The mitral replacement valve stent of claim 1, wherein, The application further relates to a connecting portion (300) which is located at the other end of the support (100), and the connecting portion (300) comprises a bendable connecting arm (310) which is formed integrally with the support (100).

9. The mitral replacement valve stent of claim 8, wherein, The support (100) is formed integrally by a plurality of hollow compression units (110) arranged in the circumferential direction, and the anchoring portion (200) and the connecting portion (300) are located at two ends of the compression unit (110) respectively.

10. The mitral replacement valve stent of claim 9, wherein, The compression unit (110) comprises a plurality of folding portions (111) arranged in the folding direction of the support (100), and a connecting rod (112) is arranged in the axial direction between the plurality of folding portions (111).

11. The mitral replacement valve stent of claim 10, wherein, The folding portion (111) comprises first and second folding arms (410 and 420), one end of the first folding arm (410) is connected with one end of the second folding arm (420), 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.

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