Mitral valve replacement system

Abstract

The invention provides a mitral valve replacement system in the technical field of medical instruments, and the mitral valve replacement system comprises a valve stent, a fixing ring and a shearing part, the fixing ring is arranged around the end face of the valve stent, and the shearing part is oppositely arranged on one side of the valve stent. The fixing ring surrounds the groove in the end face of the valve support to limit the moving direction of the valve support, so that the valve support is stably located at the native mitral valve ring, and the butterfly buckle is arranged on the valve support to buckle and clamp the native mitral valve leaflet. The fixing ring is tied and hooped at the groove in the end face of the valve support of the artificial heart valve, so that the artificial heart valve is stably positioned at the original mitral valve annulus, displacement of the artificial heart valve caused by external force factors such as blood flow impact force is prevented, and then the perivalvular leakage problem caused by displacement is avoided; the native mitral valve anterior leaflet is cut open through the cutting part, and then the cut native mitral valve anterior leaflet is buckled and clamped through the butterfly buckle, so that blood flowing through the native mitral valve anterior leaflet smoothly circulates, and the problem that the left ventricular outflow tract is obstructed is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a mitral valve replacement system. Background Art

[0002] With the aggravation of the global population aging, the incidence of heart valve diseases is increasing year by year. As one of the common heart valve diseases, the treatment demand for mitral valve is constantly increasing. The development of minimally invasive techniques such as transcatheter mitral valve replacement (TMVR) provides new options for mitral valve replacement. These techniques have the advantages of no need for thoracotomy, small surgical trauma, high safety, etc., and are especially suitable for elderly and high-risk patients. At present, there are several TMVR devices on the market and in research and development globally, including products with different paths such as transapical and transseptal. The emergence of these products provides more personalized treatment options for patients.

[0003] Although transcatheter mitral valve replacement (TMVR) has the advantages of small trauma and quick recovery, there are still some significant disadvantages and challenges. The following are the main disadvantages of transcatheter mitral valve replacement:

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

[0005] Paravalvular leakage is a unique complication after valve replacement, mostly caused by abnormal valve position. Approximately 3.5% of patients need to close the paravalvular leakage after TMVR, and the probability of hemolysis in patients with paravalvular leakage is about 3%. Although surgical operation is the main method for treating paravalvular leakage, the surgical technique is difficult, with many complications and high mortality.

[0006] 2. LVOT obstruction: Left ventricular outflow tract obstruction (LVOT obstruction) is one of the main complications of TMVR treatment. It is reported that LVOT obstruction exists in about 7% - 9% of TMVR cases, especially in patients with mitral annulus calcification, and 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. Summary of the Invention

[0007] Aiming at the defects in the prior art, the purpose of the present invention is to provide a mitral valve replacement system.

[0008] According to a mitral valve replacement system provided by the present invention, it includes a valve stent, a fixing ring and a shearing member. The fixing ring is arranged around the end face of the valve stent, and the shearing member is relatively arranged on one side of the valve stent;

[0009] The fixing ring closely surrounds and fits into the groove at the end face of the valve stent, and the fixing ring limits the moving direction of the valve stent, so that the valve stent is stably positioned at the native mitral valve annulus;

[0010] And a butterfly buckle is arranged on the valve stent, and the butterfly buckle is used to clamp the anterior leaflet of the native mitral valve.

[0011] In some embodiments, the valve stent includes a skirt stent, a stent body, as well as fixing pieces and suture pieces;

[0012] The skirt stent is connected to the top end of the stent body, and a plurality of the fixing pieces and a plurality of the suture pieces are connected to the bottom end of the stent body.

[0013] In some embodiments, the skirt stent includes curved rods, connecting rods, and an outer extension layer. The outer extension layer includes outer extension units and co-connection units, and one co-connection unit is arranged between every two outer extension units. A plurality of the outer extension units are interconnected through a plurality of the co-connection units to form the outer extension layer;

[0014] One ends of a plurality of the curved rods are connected to one end of the stent body, and the other ends of the plurality of the curved rods are connected to the outer extension units;

[0015] V-shaped connecting rods are arranged between a plurality of the curved rods, and two ends of the connecting rods are connected to the side end parts of the curved rods on both sides.

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

[0017] The first frame layer includes frame units one and connection units one, and one connection unit one is arranged between every two frame units one. A plurality of the frame units one are interconnected through a plurality of the connection units one in the same layer to form the first frame layer;

[0018] The second frame layer includes frame units two and connection units two, and one connection unit two is arranged between every two frame units two. A plurality of the frame units two are interconnected through a plurality of the connection units two in the same layer to form the second frame layer;

[0019] The third frame layer includes frame units three and connection units three, and one connection unit three is arranged between every two frame units three. A plurality of the frame units three are interconnected through a plurality of the connection units three in the same layer to form the third frame layer.

[0020] In some embodiments, the butterfly buckle is arranged at any position on the second frame layer, and the butterfly buckle includes a first fastener and a second fastener;

[0021] Moreover, the first fastener is disposed within a first frame unit, the second fastener is disposed within another frame unit, and the first and second fasteners are arranged in pairs with a frame unit interposed therebetween.

[0022] In some embodiments, the epitaxial unit is a rhombic epitaxial unit, the first frame unit is a rhombic first frame unit, the second frame unit is a rhombic second frame unit, and the third frame unit is a rhombic third frame unit.

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

[0024] Moreover, a rectangular sewing hole is provided in the middle of the sewing member, and the sewing hole is used to pass a sewing thread to sew the biological valve onto the stent body.

[0025] In some embodiments, the fixing ring includes a head end and an elastic long tube, the head end is a conical head end, and the elastic long tube is a circular hollow structure elastic long tube;

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

[0027] In some embodiments, multiple layers of raised buckles are provided on the head end, and multiple layers of inner grooves are provided in the tail end. The head end and the tail end are connected end to end through corresponding fitting of the raised buckles and the inner grooves, so that the fixing ring shrinks and fits around the end face groove of the valve stent;

[0028] Moreover, the raised buckle is made of a metal material or a polymer material, and the raised buckle is arranged at an angle of 30° - 60° on the end face of the head end.

[0029] In some embodiments, the shearing member extends out of the opening on the catheter, and shearing blades are provided on both the upper and lower sides of the shearing member;

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

[0031] In some embodiments, the valve stent is made of nitinol, the fixing ring is made of a metal material or a polymer material, the shearing member is made of a polymer material, and the shearing blades are made of a metal material.

[0032] In some embodiments,

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

[0034] 1. In the present invention, in the surrounding state, the fixing ring is tightly clamped and attached to the groove at the end face of the valve support of the artificial heart valve, so that the artificial heart valve is stably positioned at the native mitral valve annulus, preventing the artificial heart valve from shifting due to external force factors such as blood flow impact force, and thus avoiding the problem of paravalvular leakage caused by the shift.

[0035] 2. In the present invention, the native anterior mitral leaflet is cut by the cutting blade on the shearing member extending from the catheter, and then the two sides of the cut native anterior mitral leaflet are respectively clamped by the butterfly buckles on the second frame layer of the valve support, so that the blood flowing through the native anterior mitral leaflet can flow smoothly back and forth, avoiding the problem of obstruction in the left ventricular outflow tract. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] By reading the following detailed description of the non-restrictive embodiments with reference to the accompanying drawings, other features, objects and advantages of the present invention will become more apparent:

[0037] Figure 1 It is an axonometric direction structural schematic diagram of the fixing ring hoop of a mitral valve replacement system of the present invention on the valve support in the fully deployed state;

[0038] Figure 2 It is a front view direction structural schematic diagram of the fixing ring hoop of a mitral valve replacement system of the present invention on the valve support in the fully deployed state;

[0039] Figure 3 It is a side view direction structural schematic diagram of the fixing ring hoop of a mitral valve replacement system of the present invention on the valve support in the fully deployed state;

[0040] Figure 4 It is a top view direction structural schematic diagram of the fixing ring hoop of a mitral valve replacement system of the present invention on the valve support in the fully deployed state;

[0041] Figure 5 It is an axonometric direction structural schematic diagram of the valve support of a mitral valve replacement system of the present invention in the fully deployed state;

[0042] Figure 6 It is a front view direction structural schematic diagram of the valve support of a mitral valve replacement system of the present invention in the fully deployed state;

[0043] Figure 7 It is a side view direction structural schematic diagram of the valve support of a mitral valve replacement system of the present invention in the fully deployed state;

[0044] Figure 8 It is a top view direction structural schematic diagram of the valve support of a mitral valve replacement system of the present invention in the fully deployed state;

[0045] Figure 9Schematic diagram of the partial enlarged structure of the fixing member and the suture member on the valve stent in the fully deployed state of a mitral valve replacement system according to the present invention;

[0046] Figure 10 Schematic diagram of the structure of the fixing ring in the extended state of a mitral valve replacement system according to the present invention;

[0047] Figure 11 Schematic diagram of the structure of the fixing ring in the surrounding state of a mitral valve replacement system according to the present invention;

[0048] Figure 12 Schematic diagram of the partial enlarged structure of the fixing ring in the surrounding state of a mitral valve replacement system according to the present invention;

[0049] Figure 13 Schematic diagram of the head-to-tail corresponding fitting structure of the fixing ring in the surrounding state of a mitral valve replacement system according to the present invention;

[0050] Figure 14 Axonometric direction structure schematic diagram of the catheter and the shear member of a mitral valve replacement system according to the present invention;

[0051] Figure 15 Front view direction structure schematic diagram of the catheter and the shear member of a mitral valve replacement system according to the present invention;

[0052] Figure 16 Side view direction structure schematic diagram of the catheter and the shear member of a mitral valve replacement system according to the present invention;

[0053] Figure 17 Schematic diagram of the working state of the valve stent in the fully deployed state implanted at the native mitral valve annulus in the heart in Example 2 of a mitral valve replacement system according to the present invention;

[0054] Figure 18 Schematic diagram of the partial enlarged working state of the valve stent in the fully deployed state implanted at the native mitral valve annulus in the heart in Example 2 of a mitral valve replacement system according to the present invention Figure 1 ;

[0055] Figure 19 Schematic diagram of the partial enlarged working state of the valve stent in the fully deployed state implanted at the native mitral valve annulus in the heart in Example 2 of a mitral valve replacement system according to the present invention Figure 2 (The shear member cuts open the native mitral valve anterior leaf, and the butterfly buckles respectively clamp the two sides of the cut native mitral valve anterior leaf);

[0056] Figure 20 Front view direction structure schematic diagram of the valve stent in the fully deployed state in Example 2 of a mitral valve replacement system according to the present invention;

[0057] Figure 21 Schematic diagram of the structure of the valve stent in the fully deployed state in the top view direction in Embodiment 2 of a mitral valve replacement system of the present invention;

[0058] Figure 22 Schematic diagram of the structure of the hoop fixing ring on the valve stent in the fully deployed state in the front view direction in Embodiment 2 of a mitral valve replacement system of the present invention.

[0059] Reference numerals:

[0060] Valve stent 1 Frame unit three 1231

[0061] Skirt stent 11 Connection unit three 1232

[0062] Bending rod 111 Fixing part 13

[0063] Connecting rod 112 Limiting hole 131

[0064] Epitaxial layer 113 Suture 14

[0065] Epitaxial unit 1131 Suture hole 141

[0066] Common connection unit 1132 Fixing ring 2

[0067] Stent main body 12 Head end 21

[0068] Frame layer one 121 Protruding buckle 211

[0069] Frame unit one 1211 Elastic long tube 22

[0070] Connection unit one 1212 Tail end 221

[0071] Frame layer two 122 Inner groove 2211

[0072] Frame unit two 1221 Catheter 3

[0073] Connection unit two 1222 Opening 31

[0074] Butterfly buckle 12221 Shearing part 4

[0075] Fastener one 122211 Shearing blade 41

[0076] Fastener two 122212 Native mitral valve annulus 5

[0077] Frame layer three 123 Native mitral valve anterior leaf 6 Detailed implementation manners

[0078] The present invention will be described in detail below in conjunction with specific embodiments. The following embodiments will help those skilled in the art to further understand the present invention, but do not limit the present invention in any form. It should be noted that for those of ordinary skill in the art, several changes and improvements can be made without departing from the concept of the present invention. These all belong to the protection scope of the present invention.

[0079] Embodiment 1

[0080] As Figure 1-16 shown, the mitral valve replacement system of the present invention 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 relatively arranged on one side of the valve stent 1. By tightly surrounding and fitting the fixing ring 2 at the groove of the end face of the valve stent 1, the fixing ring 2 limits the moving direction of the valve stent 1, so that the valve stent 1 is stably positioned at the native mitral valve annulus 5. And a butterfly buckle 12221 is arranged on the valve stent 1, and the butterfly buckle 12221 is used to clamp the native mitral valve anterior leaflet 6.

[0081] The valve stent 1 includes a skirt stent 11, a stent body 12, as well as fixing members 13 and suturing members 14. The skirt stent 11 is connected to one end of the stent body 12, and a plurality of fixing members 13 and a plurality of suturing members 14 are connected to the other end of the stent body 12. The skirt stent 11 includes curved rods 111, connecting rods 112, and an extension layer 113. The extension layer 113 includes extension units 1131 and co-connection units 1132, and one co-connection unit 1132 is arranged between every two extension units 1131. A plurality of extension units 1131 are interconnected through a plurality of co-connection units 1132 to form the extension layer 113. One ends of a plurality of curved rods 111 are connected to the top end of the stent body 12, and the other ends of the plurality of curved rods 111 are connected to the bottom ends of the extension units 1131. Connecting rods 112 are arranged between the plurality of curved rods 111, and both ends of the connecting rods 112 are connected to the side end portions of the curved rods 111 on both sides. The stent body 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 connection units 1212, and one connection unit 1212 is arranged between every two frame units 1211. A plurality of frame units 1211 are interconnected through a plurality of connection units 1212 in the same layer to form the first frame layer 121. The second frame layer 122 includes frame units 1221 and connection units 1222, and one connection unit 1222 is arranged between every two frame units 1221. A plurality of frame units 1221 are interconnected through a plurality of connection units 1222 in the same layer to form the second frame layer 122. The third frame layer 123 includes frame units 1231 and connection units 1232, and one connection unit 1232 is arranged between every two frame units 1231. A plurality of frame units 1231 are interconnected through a plurality of connection units 1232 in the same layer to form the third frame layer 123. A butterfly buckle 12221 is arranged at any position on the second frame layer 122, and the butterfly buckle 12221 includes a first buckle 122211 and a second buckle 122212. The first buckle 122211 is arranged within one frame unit 1221, the second buckle 122212 is arranged within another frame unit 1221, and the first buckle 122211 and the second buckle 122212 are arranged in pairs with a frame unit 1221 spaced therebetween on the left and right. The extension unit 1131 adopts a diamond-shaped extension unit, the frame unit 1211 adopts a diamond-shaped first frame unit, the frame unit 1221 adopts a diamond-shaped second frame unit, and the frame unit 1231 adopts a diamond-shaped third frame unit.

[0082] A limiting hole 131 is provided at one end of the fixing member 13. In the compressed state, the valve stent 1 is buckled on the sheath of the artificial heart valve delivery device through the limiting hole 131. And a suture hole 141 is centrally provided on the suture member 14. The suture hole 141 is used to pass a suture to suture the biological valve to the stent main body 12. The fixing ring 2 includes a head end 21 and an elastic long tube 22. The head end 21 is a conical head end, and the elastic long tube 22 is a circular hollow elastic long tube. The head end 21 is connected to one end of the elastic long tube 22, and the other end of the elastic long tube 22 is the tail end 221. The outer diameter of the head end 21 is smaller than the inner diameter of the tail end 221. A plurality of layers of protruding buckles 211 are provided on the head end 21, and a plurality of layers of inner grooves 2211 are provided in the tail end 221. Through the corresponding fitting of the protruding buckles 211 and the inner grooves 2211, the head end 21 and the tail end 221 are connected end to end, so that the fixing ring 2 shrinks and binds to fit at the end face groove of the valve stent 1.

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

[0084] Specifically, in this embodiment, as Figure 5 shown, the epitaxial unit 1131, the first frame unit 1211, the second frame unit 1221, and the third frame unit 1231 all adopt a rhombus structure to achieve better hydrodynamic performance, which can significantly improve the hemodynamic effect and facilitate the smooth flow of blood flowing back and forth through the valve stent 1.

[0085] Specifically, in this embodiment, as Figure 8 shown, by suturing the biological valve to the valve stent 2, after the valve stent 2 is completely released, the skirt stent 11 also extends outwards. When the artificial heart valve using the valve stent 1 works, the effective opening area of its artificial valve leaf is larger than that of the existing artificial heart valves on the market when they work. It is more convenient for the blood flowing through the artificial heart valve to flow back and forth smoothly, which is beneficial for the patient's heart to function normally after valve replacement.

[0086] Specifically, in this embodiment, as Figure 8 shown, the connecting rod 112 is a V-shaped connecting rod. Using a V-shaped connecting rod on the skirt stent 11 has more contraction elasticity than using a general straight connecting rod, and is more conducive to loading the valve stent 1 including the skirt stent 11 in a compressed state on the sheath of the artificial heart valve delivery system.

[0087] Meanwhile, after the valve stent 1 is implanted and released in the heart and is in an expanded state, the skirt stent 11 with a V-shaped connecting rod has better hydrodynamic performance, which can improve the hemodynamic effect and facilitate the smooth flow of blood back and forth through the valve stent 1.

[0088] Specifically, in this embodiment, as Figure 9 shown, the limiting hole 131 is an oval limiting hole, and the fixing member 13 is buckled on a specific position of the sheath of the artificial heart valve delivery device through the oval limiting hole. Moreover, compared with a general circular limiting hole, the oval limiting hole has a larger range of movement. When buckling, the fixing member 13 can move in the axial direction, which is convenient for fitting and installing on the sheaths of various models of artificial heart valve delivery devices, improving the versatility.

[0089] Specifically, in this embodiment, as Figure 9 shown, the suture hole 141 is a rectangular suture hole. Compared with a general circular suture hole, the rectangular suture hole can expand the threading range of the suture thread, making the biological valve and the valve stent 1 more tightly sutured during suturing and not easily falling off.

[0090] Specifically, in this embodiment, as Figure 10 and Figure 14 shown, the fixing ring 2 and its protruding buckle 211 are both made of polymer materials, and the protruding buckle 211 is arranged at an angle of 60° on the end face of the head end 21. In addition, the valve stent 1 is made of nitinol alloy, the shear member 4 is made of polymer material, and the shear blade 41 is made of metal material.

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

[0092] Embodiment 2

[0093] As Figure 17-22 shown, the mitral valve replacement system of the present invention includes a valve stent 1, a fixing ring 2, and a shear member 4. The fixing ring 2 is arranged around the end face of the valve stent 1, and the shear member 4 is relatively arranged on one side of the valve stent 1. By closely surrounding and fitting the fixing ring 2 at the groove of the end face of the valve stent 1, the fixing ring 2 limits the moving direction of the valve stent 1, so that the valve stent 1 is stably positioned at the native mitral valve annulus 5. And a butterfly buckle 12221 is arranged on the valve stent 1, and the butterfly buckle 12221 is used to clamp the native mitral valve anterior leaflet 6.

[0094] Specifically, in this embodiment, as Figure 17-19As shown, when the valve stent 1 of the present invention is in an incompletely released state, the shearing member 4 is simultaneously extended from the catheter 3, and the native anterior mitral leaflet 6 is cut open by the shearing blade 42 on the shearing member 4.

[0095] After the valve stent 1 of the present invention is completely released, the two cut sides of the native anterior mitral leaflet 6 are respectively clamped by the butterfly buckles 12221 on the second frame layer 122 of the valve stent 1, so that the blood flow in the direction of the native anterior mitral leaflet 6 can flow smoothly back and forth, solving the problem of obstruction in the left ventricular outflow tract after replacement.

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

[0097] Specifically, in this embodiment, as Figure 22 shown, by the corresponding fitting of the convex buckle 211 on the head end 21 and the inner groove 2211 on the tail end 221 of the elastic long tube 22, the fixing ring 2 is connected end to end and changes from the extended state to the surrounding state. In the surrounding state, the fixing ring 2 shrinks and binds to fit at the end face groove of the valve stent 1 of the present invention in the completely released state, which can prevent the valve stent 1 from moving due to external forces such as the impact of blood flow, so that the valve stent 1 is stably positioned at the native mitral valve annulus 5, avoiding the occurrence of paravalvular leakage after valve replacement.

[0098] In Embodiment 1 and Embodiment 2, the working steps of a mitral valve replacement system of the present invention are as follows:

[0099] S1. First, the fixing ring 2 in the extended state is implanted in advance at the native mitral valve annulus 5 through a catheter, and the fixing ring 2 is changed from the extended state to the surrounding state by operating on the artificial heart valve delivery device;

[0100] S2. Then, the valve stent 1 with the biological valve already sutured, that is, the artificial heart valve, is loaded onto the sheath of the artificial heart valve delivery device in a compressed state after being compressed by a compressor. The sheath loaded with the artificial heart valve enters the native mitral valve annulus 5 in the heart through another catheter and starts to be released;

[0101] S3. When the artificial heart valve in step 2 is not completely released, the shearing member 4 is brought to the native anterior mitral leaflet 6 through the third catheter, that is, the catheter 3. By operating the artificial heart valve delivery device, the shearing member 4 extends from the opening 31 of the catheter 3, and the native anterior mitral leaflet 6 is cut open by the shearing blade 41 on the shearing member 4;

[0102] Meanwhile, the artificial heart valve in step 2 is fully released, and the fixing ring 2 in the surrounding state in step 1 limits the fully released artificial heart valve. The fixing ring 2 closely surrounds and fits at the groove on the end face of the valve stent 1, and the butterfly buckles 12221 on the second frame layer 122 of the valve stent 1 respectively clamp the two cut sides of the native anterior mitral leaflet 6.

[0103] Through the above operations, the fixing ring 2 in the surrounding state closely binds and fits at the groove on the end face of the valve stent 1 of the artificial heart valve, so that the artificial heart valve is stably positioned at the native mitral annulus 5, preventing the artificial heart valve from shifting due to external factors such as blood flow impact force, and thus avoiding the problem of paravalvular leakage caused by the shift.

[0104] Moreover, the native anterior mitral leaflet 6 is cut by the cutting member 4 extending from the catheter 3, and then the butterfly buckles 12221 on the second frame layer 122 of the valve stent 1 respectively clamp the two cut sides of the native anterior mitral leaflet 6, so that the blood flowing in the direction of the native anterior mitral leaflet 6 can flow smoothly back and forth, avoiding the problem of obstruction in the left ventricular outflow tract.

[0105] In the description of the present application, it should be understood that the orientation or positional relationship indicated by the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0106] The specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the above specific embodiments, and those skilled in the art can make various changes or modifications within the scope of the claims, which does not affect the essence of the present invention. Without conflict, the embodiments of the present application and the features in the embodiments can be combined arbitrarily with each other.

Claims

1. A mitral valve replacement system, 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 oppositely arranged on one side of the valve stent (1). The fixing ring (2) closely fits around the groove at the end face of the valve stent (1). The fixing ring (2) limits the moving direction of the valve stent (1), so that the valve stent (1) is stably positioned at the native mitral valve annulus (5). And a butterfly buckle (12221) is arranged on the valve stent (1), and the butterfly buckle (12221) is used to clamp the native anterior mitral leaflet (6).

2. The mitral valve replacement system according to claim 1, wherein The valve stent (1) includes a skirt stent (11), a stent body (12), a fixing member (13) and a suture member (14). The skirt stent (11) is connected to one end of the stent body (12), and a plurality of the fixing members (13) and a plurality of the suture members (14) are connected to the other end of the stent body (12).

3. The mitral valve replacement system according to claim 2, wherein, The skirt stent (11) includes a curved rod (111), a connecting rod (112) and an extension layer (113). The extension layer (113) includes extension units (1131) and co - connecting units (1132). And one co - connecting unit (1132) is arranged between every two of the extension units (1131). A plurality of the extension units (1131) are interconnected through a plurality of the co - connecting units (1132) to form the extension layer (113). One ends of a plurality of the curved rods (111) are connected to one end of the stent body (12), and the other ends of the plurality of the curved rods (111) are connected to the extension units (1131). Connecting rods (112) are arranged between the plurality of the curved rods (111), and both ends of the connecting rod (112) are connected to the side ends of the curved rods (111) on both sides.

4. The mitral valve replacement system according to claim 3, characterized in that, The stent body (12) includes a first frame layer (121), a second frame layer (122) and a third frame layer (123). The first frame layer (121) includes first frame units (1211) and first connecting units (1212). And one first connecting unit (1212) is arranged between every two of the first frame units (1211). A plurality of the first frame units (1211) are interconnected through a plurality of the first connecting units (1212) in the same layer to form the first frame layer (121). The second frame layer (122) includes second frame units (1221) and second connecting units (1222). And one second connecting unit (1222) is arranged between every two of the second frame units (1221). A plurality of the second frame units (1221) are interconnected through a plurality of the second connecting units (1222) in the same layer to form the second frame layer (122). The frame layer three (123) includes frame unit three (1231) and connection unit three (1232), and one connection unit three (1232) is arranged between every two frame units three (1231). A plurality of frame units three (1231) are interconnected on the same layer through a plurality of connection units three (1232) to form the frame layer three (123).

5. The mitral valve replacement system according to claim 4, characterized in that, The butterfly buckle (12221) is arranged at any position on the frame layer two (122), and the butterfly buckle (12221) includes buckle one (122211) and buckle two (122212); The buckle one (122211) is arranged within one frame unit two (1221), the buckle two (122212) is arranged within another frame unit two (1221), and the buckle one (122211) and the buckle two (122212) are arranged in pairs with one frame unit two (1221) spaced therebetween.

6. The mitral valve replacement system according to claim 5, characterized in that, The epitaxial unit (1131) includes a rhombic epitaxial unit, the frame unit one (1211) includes a rhombic frame unit one, the frame unit two (1221) includes a rhombic frame unit two, and the frame unit three (1231) includes a rhombic frame unit three.

7. The mitral valve replacement system according to claim 2, wherein, One end of the fixing member (13) is provided with a limit hole (131), and in a compressed state, the valve stent (1) is buckled on the sheath of the artificial heart valve delivery device through the limit hole (131); A suture hole (141) is centrally arranged on the suture member (14), and the suture hole (141) is used to pass a suture to suture the biological valve to the stent body (12).

8. The mitral valve replacement system according to claim 1, wherein The fixing ring (2) includes a head end (21) and an elastic long tube (22), and the head end (21) includes a conical head end, and the elastic long tube (22) includes a circular hollow structure elastic long tube; The head end (21) is connected to one end of the elastic long tube (22), and the other end of the head end (21) is a 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 system according to claim 8, wherein, A plurality of layers of raised buckles (211) are arranged on the head end (21), and a plurality of layers of inner grooves (2211) are arranged inside the tail end (221); Through the corresponding engagement of the raised buckles (211) and the inner grooves (2211), the head end (21) and the tail end (221) are connected end to end, so that the fixing ring (2) shrinks and binds to fit at the end face groove of the valve stent (1); The material of the raised buckle (211) is any one of a metal material or a polymer material, and the raised buckle (211) is arranged at an angle of 30° - 60° on the end face of the head end (21).

10. The mitral valve replacement system according to claim 5, characterized in that, The shearing member (4) extends out from the opening (31) of the catheter (3), and shearing blades (41) are arranged on the upper and lower sides of the shearing member (4); The native anterior mitral leaflet (6) is cut open by the shearing blades (41), and the butterfly buckle (12221) is used to respectively clamp the two sides of the cut native anterior mitral leaflet (6).

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