A mitral valve replacement device

Abstract

The utility model provides a kind of mitral valve replacement device in the technical field of medical equipment, including valve support, fixed ring and shear piece, fixed ring is set around valve support end face, and shear piece is oppositely arranged in valve support side. Fixed ring is limited its moving direction around the groove at valve support end face, so that valve support is stably fixed in native mitral valve annulus, and butterfly buckle clamping native mitral valve leaflet is set on valve support. The utility model is fixed by fixed ring hoop in the groove at valve support end face of artificial heart valve, so that artificial heart valve is stably fixed in native mitral valve annulus, prevent artificial heart valve from being displaced due to blood flow impact force and other external factors, to avoid the problem of perivalvular leakage caused by displacement, and the native mitral valve anterior leaflet is cut by shear piece, and then the native mitral valve anterior leaflet is cut by butterfly buckle clamping, so that the blood flowing through native mitral valve anterior leaflet flows smoothly, avoid left ventricular outflow tract obstruction problem.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a mitral valve replacement device. Background Technology

[0002] With the increasing aging of the global population, the incidence of valvular heart disease is also rising year by year. As one of the most common valvular heart diseases, the demand for mitral valve treatment is constantly increasing. The development of minimally invasive techniques such as transcatheter mitral valve replacement (TMVR) has provided new options for mitral valve replacement. These techniques have advantages such as not requiring open-heart surgery, minimal surgical trauma, and high safety, making them particularly suitable for elderly and high-risk patients. Currently, several TMVR devices are available on the market and under development globally, including products using different pathways such as transapical and transseptal approaches. The emergence of these products provides patients with more personalized treatment options.

[0003] While transcatheter mitral valve replacement (TMVR) offers advantages such as minimal invasiveness and rapid recovery, it still presents some significant drawbacks and challenges. The main disadvantages of TMVR are as follows:

[0004] 1. Difficulty in positioning and anchoring: The mitral valve has a complex anatomical structure and dynamics, which makes the delivery, positioning, anchoring, and sealing of the artificial valve within the patient's body more difficult. Inaccurate positioning or anchoring may lead to complications such as paravalvular leakage.

[0005] Paravalvular leak is a complication specific to valve replacement, mostly caused by abnormal valve position. Approximately 3.5% of patients with paravalvular leak require closure after TMVR, and about 3% of these patients experience hemolysis. Although surgery is the primary treatment for paravalvular leak, it is technically challenging, has many complications, and a high mortality rate.

[0006] 2. LVOT Obstruction: Left ventricular outflow tract obstruction (LVOT obstruction) is one of the major complications of TMVR treatment. It has been reported that LVOT obstruction occurs in approximately 7%–9% of TMVR cases, especially in patients with mitral annular calcification, where the LVOT obstruction rate is as high as 11%. LVOT obstruction is associated with poor prognosis and may lead to symptoms such as heart failure. Utility Model Content

[0007] In view of the deficiencies in the prior art, the purpose of this utility model is to provide a mitral valve replacement device.

[0008] A mitral valve replacement device according to the present invention includes a valve support, a fixing ring and a shearing member. The fixing ring is arranged around the end face of the valve support, and the shearing member is arranged opposite to one side of the valve support.

[0009] The fixing ring tightly surrounds and fits the groove on the end face of the valve stent, and the fixing ring limits the movement direction of the valve stent, so that the valve stent is stably positioned at the original mitral valve annulus.

[0010] Furthermore, the valve stent is equipped with a butterfly buckle, which is used to fasten the original anterior leaflet of the mitral valve.

[0011] In some embodiments, the valve stent includes a skirt stent, a stent body, and fasteners and sutures;

[0012] The skirt bracket is connected to the top of the bracket body, and the plurality of fasteners and the plurality of sewing pieces are connected to the bottom of the bracket body.

[0013] In some embodiments, the skirt support includes a bending rod, a connecting rod, and an epitaxial layer. The epitaxial layer includes epitaxial units and common connection units, and a common connection unit is provided between every two epitaxial units. Multiple epitaxial units are interconnected through multiple common connection units to form the epitaxial layer.

[0014] One end of each of the multiple bending rods is connected to one end of the support body, and the other end of each of the multiple bending rods is connected to the extension unit;

[0015] A V-shaped connecting rod is provided between the multiple bending rods, and the two ends of the connecting rod are connected to the side ends of the two bending rods.

[0016] In some embodiments, the support body includes a first frame layer, a second frame layer, and a third frame layer;

[0017] The first frame layer includes a first frame unit and a first connecting unit, and a first connecting unit is provided between every two first frame units. Multiple first frame units are interconnected on the same layer through multiple first connecting units to form the first frame layer.

[0018] The second frame layer includes a second frame unit and a second connection unit, and a second connection unit is provided between every two second frame units. Multiple second frame units are interconnected in the same layer through multiple second connection units to form the second frame layer.

[0019] The third frame layer includes a third frame unit and a third connecting unit, with a third connecting unit provided between every two third frame units. Multiple third frame units are interconnected in the same layer through multiple third connecting units to form the third frame layer.

[0020] In some embodiments, the butterfly buckle is disposed at any point on the second frame layer, and the butterfly buckle includes fastener one and fastener two;

[0021] Furthermore, the first fastener is installed in one frame unit two, and the second fastener is installed in another frame unit two, with the first fastener and the second fastener being installed in pairs with a frame unit two spaced apart.

[0022] In some implementations, the extension unit is a rhombus extension unit, the first frame unit is a rhombus frame unit, the second frame unit is a rhombus frame unit, and the third frame unit is a rhombus frame unit.

[0023] In some embodiments, an elliptical limiting hole is provided at one end of the fixing member, and the valve stent is snapped onto the sheath of the artificial heart valve delivery device through the limiting hole in the compressed state;

[0024] Furthermore, a rectangular suture hole is provided in the center of the suture piece, which is used to pass through the suture thread to suture the bioprosthetic valve onto the stent body.

[0025] In some embodiments, the fixing ring includes a head end and an elastic tube, wherein the head end is a tapered head end and the elastic tube is a circular hollow elastic tube.

[0026] The head end is connected to one end of the elastic tube, and the other end of the head end is the tail end, with the outer diameter of the head end being smaller than the inner diameter of the tail end.

[0027] In some embodiments, the head end is provided with multiple layers of protruding buckles, and the tail end is provided with multiple layers of inner grooves. The protruding buckles are fitted into the inner grooves in a corresponding manner, and the head end and the tail end are connected end to end, so that the fixing ring shrinks and fits into the groove on the end face of the valve stent.

[0028] Furthermore, the protruding buckle is made of metal or polymer material, and the protruding buckle is set at an angle of 30° to 60° on the end face of the head.

[0029] In some embodiments, the shearing member extends from an opening in the conduit, and shearing blades are provided on the upper and lower sides of the shearing member;

[0030] The native anterior mitral leaflet is cut open by the shearing blade, and the butterfly buckle is used to clamp the cut native anterior mitral leaflet on both sides respectively.

[0031] In some embodiments, the valve stent is made of nickel-titanium alloy, the fixing ring is made of metal or polymer, the shearing element is made of polymer, and the shearing blade is made of metal.

[0032] In some implementations,

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] 1. This utility model uses a fixing ring that is tightly fastened to the groove on the end face of the valve stent of the artificial heart valve in a circumferential state, so that the artificial heart valve is stably positioned at the original mitral valve annulus, preventing the artificial heart valve from shifting due to external forces such as blood flow impact, thereby avoiding paravalvular leakage caused by displacement.

[0035] 2. This utility model uses a shearing blade on a shearing piece extending from the catheter to cut open the native anterior leaflet of the mitral valve. Then, the butterfly buckle on the second frame layer of the valve stent is used to clamp the two cut sides of the native anterior leaflet of the mitral valve, so that the blood flowing through the native anterior leaflet of the mitral valve can flow smoothly back and forth, avoiding obstruction of the left ventricular outflow tract. Attached Figure Description

[0036] Other features, objects, and advantages of this invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings:

[0037] Figure 1 This is an isometric structural diagram of the fixing ring of the mitral valve replacement device of this utility model on the valve stent in the fully deployed state.

[0038] Figure 2 This is a schematic diagram of the front view of the fixing ring of the mitral valve replacement device of this utility model on the valve stent in the fully deployed state.

[0039] Figure 3 This is a side view of the structure of the fixing ring of the mitral valve replacement device of the present invention on the valve stent in the fully deployed state;

[0040] Figure 4 This is a top view of the structure of the fixing ring of the mitral valve replacement device of this utility model on the valve stent in the fully deployed state.

[0041] Figure 5 This is an isometric structural diagram of the valve stent in the fully deployed state of a mitral valve replacement device according to this utility model.

[0042] Figure 6 This is a front view structural diagram of the valve stent in the fully deployed state of the mitral valve replacement device according to this utility model.

[0043] Figure 7 This is a side view of the valve stent in the fully deployed state of the mitral valve replacement device of this utility model.

[0044] Figure 8 This is a top view of the valve stent in the fully deployed state of the mitral valve replacement device of this utility model.

[0045] Figure 9 This is a partially enlarged structural diagram of the fixation and suture components on the valve support in the fully deployed state of the mitral valve replacement device of this utility model.

[0046] Figure 10 This is a schematic diagram of the structure of the fixed ring of the mitral valve replacement device in the extended state.

[0047] Figure 11 This is a schematic diagram of the structure of a mitral valve replacement device in the state of the fixed ring surrounding the device.

[0048] Figure 12 This is a partially enlarged structural diagram of a mitral valve replacement device in the state of the fixed ring surrounding the device.

[0049] Figure 13 This is a schematic diagram of the end-to-end fitting structure of the fixed ring of the mitral valve replacement device of this utility model in the state of being surrounded by the fixed ring;

[0050] Figure 14 This is a schematic diagram of the axial direction structure of the catheter and shearing element of the mitral valve replacement device of this utility model.

[0051] Figure 15 This is a schematic diagram of the catheter and shearing component of a mitral valve replacement device according to the present invention from the front view direction.

[0052] Figure 16 This is a side view of the catheter and shearing components of a mitral valve replacement device according to this utility model.

[0053] Figure 17 This is a schematic diagram of the fully deployed valve stent implanted in the original mitral valve annulus in the heart during Embodiment 2 of the mitral valve replacement device of this utility model.

[0054] Figure 18 This is a magnified view of a portion of the fully deployed valve stent implanted in the heart at the original mitral valve annulus in Embodiment 2 of the mitral valve replacement device of this utility model. Figure 1 ;

[0055] Figure 19 This is a magnified view of a portion of the fully deployed valve stent implanted in the heart at the original mitral valve annulus in Embodiment 2 of the mitral valve replacement device of this utility model. Figure 2 (The shearing piece cuts open the original anterior leaflet of the mitral valve, and the butterfly buckle fastens the cut original anterior leaflets on both sides respectively);

[0056] Figure 20This is a schematic diagram of the valve stent in its fully deployed state in the main view direction of Embodiment 2 of the mitral valve replacement device of this utility model;

[0057] Figure 21 This is a top view of the valve stent in the fully deployed state in Embodiment 2 of the mitral valve replacement device of this utility model.

[0058] Figure 22 This is a front view structural diagram of the clamping and fixing ring on the valve stent in the fully deployed state in Embodiment 2 of the mitral valve replacement device of this utility model.

[0059] Figure label:

[0060] Valve stent 1 Frame unit three 1231

[0061] Skirt bracket 11 Connecting unit three 1232

[0062] Bending rod 111, fastener 13

[0063] Connecting rod 112, limiting hole 131

[0064] Epitaxial layer 113, stitching 14

[0065] Epitaxial unit 1131, seam hole 141

[0066] Common connection unit 1132, fixing ring 2

[0067] Support body 12, head end 21

[0068] Frame layer 121 protruding buckle 211

[0069] Frame Unit 1211 Elastic Long Tube 22

[0070] Connection Unit 1212 Tail End 221

[0071] Frame layer 2 122 Inner groove 2211

[0072] Frame Unit 2 1221 Conduit 3

[0073] Connection unit 2 1222 Opening 31

[0074] Butterfly buckle 12221 Cut piece 4

[0075] Fastener 122211, Shearing Blade 41

[0076] Fastener 2 122212 Original mitral valve annulus 5

[0077] Frame layer 3 123 Original mitral valve anterior leaflet 6 Detailed Implementation

[0078] The present invention will now be described in detail with reference to specific embodiments. These embodiments will help those skilled in the art to further understand the present invention, but do not limit the present invention in any way. It should be noted that those skilled in the art can make several changes and improvements without departing from the concept of the present invention. These all fall within the protection scope of the present invention.

[0079] Example 1

[0080] like Figure 1-16 As shown, the mitral valve replacement device of this invention includes a valve support 1, a fixing ring 2, and a shearing member 4. The fixing ring 2 is arranged around the end face of the valve support 1, and the shearing member 4 is arranged opposite to one side of the valve support 1. By tightly surrounding and fitting the groove on the end face of the valve support 1 with the fixing ring 2, the fixing ring 2 limits the movement direction of the valve support 1, so that the valve support 1 is stably positioned at the original mitral valve annulus 5. Furthermore, a butterfly buckle 12221 is provided on the valve support 1, which is used to clamp the original mitral valve anterior leaflet 6.

[0081] The valve stent 1 includes a skirted stent 11, a stent body 12, fixation members 13, and sutures 14. The skirted stent 11 is connected to one end of the stent body 12, and multiple fixation members 13 and multiple sutures 14 are connected to the other end of the stent body 12. The skirted stent 11 includes curved rods 111, connecting rods 112, and an epitaxial layer 113. The epitaxial layer 113 includes epitaxial units 1131 and common connection units 1132, with a common connection unit 1132 between every two epitaxial units 1131. Multiple epitaxial units 1131 are interconnected through multiple common connection units 1132 to form the epitaxial layer 113. One end of each curved rod 111 is connected to the top of the stent body 12, and the other end of each curved rod 111 is connected to the bottom end of the epitaxial unit 1131. Connecting rods 112 are provided between the multiple curved rods 111, and both ends of the connecting rods 112 are connected to the side ends of the curved rods 111 on both sides. The support structure 12 includes a first frame layer 121, a second frame layer 122, and a third frame layer 123. The first frame layer 121 includes frame units 1211 and connecting units 1212, with one connecting unit 1212 between every two frame units 1211. Multiple frame units 1211 are interconnected on the same layer through multiple connecting units 1212 to form the first frame layer 121. The second frame layer 122 includes frame units 2221 and connecting units 2222, with one connecting unit 2222 between every two frame units 2221. Multiple frame units 2221 are interconnected on the same layer through multiple connecting units 2222 to form the second frame layer 122. Frame layer 3 123 includes frame unit 3 1231 and connecting unit 3 1232, with one connecting unit 3 1232 between every two frame units 3 1231. Multiple frame units 3 1231 are interconnected on the same layer through multiple connecting units 3 1232 to form frame layer 3 123. A butterfly buckle 12221 is disposed at any point on frame layer 2 122, and the butterfly buckle 12221 includes fastener 1 122211 and fastener 2 122212. Fastener 1 122211 is disposed within one frame unit 2 1221, and fastener 2 122212 is disposed within another frame unit 2 1221. Fastener 1 122211 and fastener 2 122212 are arranged in pairs, with a gap of one frame unit 2 1221 between them. The extension unit 1131 adopts a rhombus extension unit, the frame unit 1211 adopts a rhombus frame unit 1, the frame unit 2 1221 adopts a rhombus frame unit 2, and the frame unit 3 1231 adopts a rhombus frame unit 3.

[0082] A limiting hole 131 is provided at one end of the fixing member 13. When the valve stent 1 is compressed, it is snapped onto the sheath of the artificial heart valve delivery device through the limiting hole 131. A suture hole 141 is provided in the center of the suture member 14. The suture hole 141 is used to pass through the suture suture to suture the bioprosthetic valve onto the stent body 12. The fixing ring 2 includes a head end 21 and an elastic tube 22. The head end 21 is tapered, and the elastic tube 22 is a circular hollow elastic tube. The head end 21 is connected to one end of the elastic tube 22, and the other end of the elastic tube 22 is a tail end 221. The outer diameter of the head end 21 is smaller than the inner diameter of the tail end 221. The head end 21 is provided with multiple layers of protruding buckles 211, and the tail end 221 is provided with multiple layers of inner grooves 2211. The protruding buckles 211 and the inner grooves 2211 are fitted together, and the head end 21 and the tail end 221 are connected end to end, so that the fixing ring 2 shrinks and fits into the groove on the end face of the valve stent 1.

[0083] The shearing member 4 extends from the opening 31 on the catheter 3, and shearing blades 41 are provided on the upper and lower sides of the shearing member 4. The original anterior leaflet 6 of the mitral valve is cut open by the shearing blades 41, and the butterfly buckle 12221 is used to clamp the cut original anterior leaflet 6 on both sides respectively.

[0084] Specifically, in this embodiment, such as Figure 5 As shown, the extension unit 1131, frame unit one 1211, frame unit two 1221 and frame unit three 1231 all adopt a rhomboid structure to achieve better hydrodynamic performance, which can significantly improve the blood flow dynamics effect and facilitate the smooth flow of blood through the valve stent 1.

[0085] Specifically, in this embodiment, such as Figure 8 As shown, by suturing the bioprosthetic valve to the valve stent 2, after the valve stent 2 is fully released, the skirt stent 11 also extends outward. When the artificial heart valve using the valve stent 1 is working, its effective opening area of ​​the artificial valve leaflet is larger than that of existing artificial heart valves on the market, which makes it easier for blood to flow smoothly back and forth through the artificial heart valve, thus helping the patient's heart to function normally after valve replacement.

[0086] Specifically, in this embodiment, such as Figure 8 As shown, the connecting rod 112 adopts a V-shaped connecting rod. Compared with the use of a general straight connecting rod, the V-shaped connecting rod on the skirt support 11 has more contractile elasticity, which is more conducive to the valve stent 1 containing the skirt support 11 being loaded into the sheath of the artificial heart valve delivery device in a compressed state.

[0087] Meanwhile, after the valve stent 1 is implanted and deployed in the heart, the skirt stent 11 with V-shaped connecting rods has better hydrodynamic performance, which can improve the blood flow dynamics and facilitate the smooth flow of blood through the valve stent 1.

[0088] Specifically, in this embodiment, such as Figure 9 As shown, the limiting hole 131 is an elliptical limiting hole. The fixing member 13 is fastened to a specific position on the sheath of the artificial heart valve delivery device through the elliptical limiting hole. Compared with the general circular limiting hole, the elliptical limiting hole has a larger range of motion. When fastening, the fixing member 13 can move in the axial direction, which makes it easy to adapt and install on the sheath of various models of artificial heart valve delivery devices, thus improving versatility.

[0089] Specifically, in this embodiment, such as Figure 9 As shown, the suture hole 141 is a rectangular suture hole. Compared with the general circular suture hole, the rectangular suture hole can expand the suture threading range, making the bioprosthetic valve and valve stent 1 more tightly sutured during suturing and less likely to fall off.

[0090] Specifically, in this embodiment, such as Figure 10 and Figure 14 As shown, the fixing ring 2 and its protruding buckle 211 are both made of polymer material, and the protruding buckle 211 is set at an angle of 60° on the end face of the head end 21. The valve support 1 is made of nickel-titanium alloy, the shearing part 4 is made of polymer material, and the shearing blade 41 is made of metal material.

[0091] Specifically, in this embodiment, such as Figure 14-16 As shown, the opening 31 is a rectangular opening, and the inner width of the rectangular opening is greater than the outer width of the shearing piece 4, which makes it convenient for the shearing piece 4 to extend or retract from the rectangular opening without causing jamming, thus avoiding affecting the smooth progress of the replacement surgery.

[0092] Example 2

[0093] like Figure 17-22 As shown, the mitral valve replacement device of this invention includes a valve support 1, a fixing ring 2, and a shearing member 4. The fixing ring 2 is arranged around the end face of the valve support 1, and the shearing member 4 is arranged opposite to one side of the valve support 1. By tightly surrounding and fitting the groove on the end face of the valve support 1 with the fixing ring 2, the fixing ring 2 limits the movement direction of the valve support 1, so that the valve support 1 is stably positioned at the original mitral valve annulus 5. Furthermore, a butterfly buckle 12221 is provided on the valve support 1, which is used to clamp the original mitral valve anterior leaflet 6.

[0094] Specifically, in this embodiment, such as Figure 17-19As shown, in the state where the valve stent 1 of this utility model is not fully released, a shearing member 4 extends from the catheter 3 and the shearing blade 42 on the shearing member 4 cuts open the original anterior leaflet 6 of the mitral valve.

[0095] After the valve stent 1 of this utility model is fully released, the two original mitral valve anterior leaflets 6 that have been cut open are respectively clamped by the butterfly buckles 12221 on the frame layer 2 122 of the valve stent 1, so that the blood flow in the direction of the original mitral valve anterior leaflet 6 can flow smoothly back and forth, solving the problem of obstruction of the left ventricular outflow tract after replacement.

[0096] Specifically, in this embodiment, such as Figure 20 As shown, the butterfly buckle 12221 on the frame layer 2 122 of the valve stent 1 in Embodiment 2 has a larger bending angle than the butterfly buckle 12221 in Embodiment 1, which is more conducive to clamping the original anterior mitral valve leaflet 6 cut by the shearing piece 4.

[0097] Specifically, in this embodiment, such as Figure 22 As shown, the protruding buckle 211 on the head end 21 and the inner groove 2211 on the tail end 221 of the elastic tube 22 are correspondingly fitted together. The fixing ring 2 is connected end to end, changing from an extended state to a wrapped state. In the wrapped state, the fixing ring 2 shrinks and clamps against the groove on the end face of the valve stent 1 of this utility model in the fully released state. This can prevent the valve stent 1 from moving under the impact of blood flow and other external forces, so that the valve stent 1 is stably positioned at the original mitral valve annulus 5, avoiding paravalvular leakage after valve replacement.

[0098] In Examples 1 and 2, the working steps of the mitral valve replacement device of this utility model are as follows:

[0099] S1. First, the fixed ring 2 in the extended state is pre-implanted into the original mitral valve annulus 5 through a catheter, and the fixed ring 2 is changed from the extended state to the encircling state by operating on the artificial heart valve delivery device.

[0100] S2. Then, the valve stent 1, which has been sutured with a bioprosthetic valve, is compressed by a pressure gripper and loaded onto the sheath of the artificial heart valve delivery device. The sheath containing the artificial heart valve is then inserted into the native mitral valve annulus 5 in the heart through another catheter and begins to release.

[0101] S3. When the artificial heart valve is not fully released in step 2, the shearing piece 4 is brought into the native anterior mitral valve leaflet 6 through the third catheter, namely catheter 3. By operating the artificial heart valve delivery device, the shearing piece 4 extends out from the opening 31 of catheter 3 and the shearing blade 41 on the shearing piece 4 cuts open the native anterior mitral valve leaflet 6.

[0102] At the same time, the artificial heart valve in step 2 is completely released, and the fixing ring 2 in step 1 in the surrounding state limits the artificial heart valve in the fully released state. The fixing ring 2 is tightly wrapped around and attached to the groove on the end face of the valve stent 1, and the butterfly buckle 12221 on the frame layer 2 122 of the valve stent 1 just happens to clamp the two sides of the original mitral valve anterior leaflet 6 that have been cut open.

[0103] Through the above operations, the fixing ring 2 is tightly fastened to the groove on the end face of the valve stent 1 of the artificial heart valve in the surrounding state, so that the artificial heart valve is stably positioned at the original mitral valve annulus 5, preventing the artificial heart valve from shifting due to external forces such as blood flow impact, thereby avoiding paravalvular leakage caused by displacement.

[0104] Furthermore, the native anterior leaflet 6 of the mitral valve is cut open by the shearing piece 4 extending from the catheter 3, and then the butterfly buckle 12221 on the frame layer 2 122 of the valve stent 1 is used to clamp the cut native anterior leaflet 6 on both sides, so that the blood flowing through the native anterior leaflet 6 can flow smoothly back and forth, avoiding obstruction of the left ventricular outflow tract.

[0105] In the description of this application, it should be understood that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0106] The specific embodiments of this utility model have been described above. It should be understood that this utility model is not limited to the specific embodiments described above, and those skilled in the art can make various changes or modifications within the scope of the claims, which do not affect the substantive content of this utility model. Unless otherwise specified, the embodiments and features described in this application can be arbitrarily combined with each other.

Claims

1. A mitral valve replacement device, characterized in that, It includes a valve stent (1), a fixing ring (2) and a shearing member (4). The fixing ring (2) is arranged around the end face of the valve stent (1), and the shearing member (4) is arranged opposite to one side of the valve stent (1). The fixing ring (2) tightly surrounds and fits the groove on the end face of the valve stent (1), and the fixing ring (2) limits the movement direction of the valve stent (1), so that the valve stent (1) is stably positioned at the original mitral valve annulus (5). Furthermore, a butterfly buckle (12221) is provided on the valve stent (1), and the butterfly buckle (12221) clamps the original anterior leaflet of the mitral valve (6).

2. The mitral valve replacement device according to claim 1, characterized in that, The valve stent (1) includes a skirted stent (11), a stent body (12), a fixation element (13), and a suture element (14); The skirt bracket (11) is connected to one end of the bracket body (12), and the plurality of fasteners (13) and the plurality of sewing pieces (14) are connected to the other end of the bracket body (12).

3. The mitral valve replacement device according to claim 2, characterized in that, The skirt support (11) includes a bending rod (111), a connecting rod (112), and an epitaxial layer (113). The epitaxial layer (113) includes epitaxial units (1131) and common connection units (1132), and a common connection unit (1132) is provided between every two epitaxial units (1131). Multiple epitaxial units (1131) are interconnected through multiple common connection units (1132) to form the epitaxial layer (113). One end of each of the multiple bending rods (111) is connected to one end of the support body (12), and the other end of each of the multiple bending rods (111) is connected to the extension unit (1131); A connecting rod (112) is provided between the plurality of the bending rods (111), and the two ends of the connecting rod (112) are connected to the side ends of the bending rods (111) on both sides.

4. The mitral valve replacement device according to claim 3, characterized in that, The main body of the support (12) includes frame layer one (121), frame layer two (122) and frame layer three (123); The first frame layer (121) includes a first frame unit (1211) and a first connecting unit (1212), and a first connecting unit (1212) is provided between every two first frame units (1211). Multiple first frame units (1211) are interconnected in the same layer through multiple first connecting units (1212) to form the first frame layer (121). The second frame layer (122) includes a second frame unit (1221) and a second connection unit (1222), and a second connection unit (1222) is provided between every two second frame units (1221). Multiple second frame units (1221) are interconnected in the same layer through multiple second connection units (1222) to form the second frame layer (122). The third frame layer (123) includes a third frame unit (1231) and a third connecting unit (1232), and a third connecting unit (1232) is provided between every two third frame units (1231). Multiple third frame units (1231) are interconnected in the same layer through multiple third connecting units (1232) to form the third frame layer (123).

5. The mitral valve replacement device according to claim 4, characterized in that, The butterfly buckle (12221) is disposed at any point on the second frame layer (122), and the butterfly buckle (12221) includes fastener one (122211) and fastener two (122212); Furthermore, the first fastener (122211) is disposed in a frame unit two (1221), and the second fastener (122212) is disposed in another frame unit two (1221). The first fastener (122211) and the second fastener (122212) are arranged in pairs with a frame unit two (1221) spaced apart.

6. The mitral valve replacement device according to claim 5, characterized in that, The extension unit (1131) includes a rhombus extension unit, the first frame unit (1211) includes a rhombus frame unit, the second frame unit (1221) includes a rhombus frame unit, and the third frame unit (1231) includes a rhombus frame unit.

7. The mitral valve replacement device according to claim 2, characterized in that, A limiting hole (131) is provided at one end of the fixing member (13), and the valve stent (1) is snapped onto the sheath of the artificial heart valve delivery device through the limiting hole (131) in the compressed state; Furthermore, a suture hole (141) is provided in the center of the suture (14), and the suture hole (141) is used to pass through the suture thread to suture the bioprosthetic valve onto the stent body (12).

8. The mitral valve replacement device according to claim 1, characterized in that, The fixing ring (2) includes a head end (21) and an elastic tube (22), wherein the head end (21) includes a tapered head end and the elastic tube (22) includes a circular hollow elastic tube. The head end (21) is connected to one end of the elastic tube (22), and the other end of the head end (21) is the tail end (221), and the outer diameter of the head end (21) is smaller than the inner diameter of the tail end (221).

9. The mitral valve replacement device according to claim 8, characterized in that, The head end (21) is provided with multiple layers of protruding buckles (211), and the tail end (221) is provided with multiple layers of inner grooves (2211); The protruding buckle (211) is fitted into the inner groove (2211) in a corresponding manner, and the head end (21) and the tail end (221) are connected end to end, so that the fixing ring (2) shrinks and clamps against the groove on the end face of the valve stent (1); Furthermore, the protruding buckle (211) is made of either metal or polymer material, and the protruding buckle (211) is set at an angle of 30° to 60° on the end face of the head end (21).

10. The mitral valve replacement device according to claim 5, characterized in that, The shearing member (4) extends from the opening (31) on the conduit (3), and shearing blades (41) are provided on the upper and lower sides of the shearing member (4); The native anterior mitral leaflet (6) is cut open by the shearing blade (41), and the butterfly buckle (12221) clamps the cut sides of the native anterior mitral leaflet (6).

Images