A tricuspid valve prosthesis fixed to the interventricular septum to prevent paravalvular leakage

Abstract

This application belongs to the field of medical devices, and particularly relates to a tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage, which includes a stent, artificial valve leaflets, a sealing device, and an anchor. The artificial valve leaflets are arranged inside the stent, and the proximal end of the stent is fixed on the interventricular septum tissue of the patient through the anchor. The sealing device is connected to the stent. The sealing device includes a plurality of sealing rods and an elastic adaptation layer. The sealing rods are arranged in an arc structure, and the elastic adaptation layer covers or connects the free end portion of the sealing rods. After the stent is installed in place, the autologous valve annulus abuts and fits against the elastic adaptation layer. Moreover, the elastic adaptation layer can generate a compliant deformation with the expansion of the autologous valve annulus, so that the elastic adaptation layer always abuts against the autologous valve annulus.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and particularly relates to a tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage. Background Art

[0002] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular dilation, and tricuspid annulus dilation. Clinically, the manifestations of the causes of tricuspid regurgitation (such as left heart failure, pulmonary hypertension, etc.) are common. After tricuspid regurgitation occurs, right heart failure symptoms such as fatigue, ascites, edema, hepatic pain, indigestion, and anorexia are aggravated. Mild tricuspid regurgitation has no obvious clinical symptoms, but when severe regurgitation occurs, surgical treatment is required.

[0003] Traditional treatment methods for mitral and tricuspid valve diseases include drug treatment applicable to mild to severe regurgitation and surgical methods with corresponding surgical indications. Among them, surgical methods also include valve replacement and valve repair. In surgical methods, typical open-chest and open-heart surgeries are overly invasive, require extracorporeal circulation, and have a high incidence of complications and infection risks. Many patients cannot tolerate the huge surgical risks and can only helplessly wait for death.

[0004] In a self-adaptive cardiac valve prosthesis in Patent CN201610921109.8, a stent and an artificial valve are disclosed. The stent includes a leak-proof ring and a valve sewing section. The leak-proof ring is connected to the valve sewing section. The artificial valve is fixedly connected to the valve sewing section. The valve sewing section is at least partially located between the patient's own valve leaflets. In a cross-section perpendicular to the central axis of the artificial valve, the cross-sectional area of the valve sewing section is smaller than the cross-sectional area of the patient's own valve annulus, so that the valve sewing section does not directly radially expand the patient's own valve annulus. In a free state, the cross-sectional area of the leak-proof ring is larger than the cross-sectional area of the patient's own valve annulus, and the leak-proof ring can conform to the uneven contour of the atrial wall or the patient's own valve annulus. Although the leak-proof ring in this technical solution can cover the entire autologous valve annulus with a relatively large cross-sectional area, the outer peripheral edge of the leak-proof ring cannot completely fit the autologous valve annulus. During the contraction and relaxation of the atrium, the leak-proof ring will be squeezed, resulting in paravalvular leakage. Especially when the leak-proof ring has an eccentric structural design to adapt to the fixed position of the stent, the areas of the anterior valve region and the posterior valve region corresponding to the leak-proof ring are relatively large. The large-area leak-proof ring makes its tightness worse, and more serious paravalvular leakage will occur.

[0005] Therefore, those skilled in the art are committed to developing a tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage, so that no matter whether the autologous valve annulus is in a contracted or relaxed state after the valve prosthesis is implanted, the sealing device always abuts against the autologous valve annulus, avoiding problems such as paravalvular leakage in the implanted prosthesis. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage, so that regardless of whether the autologous valve annulus is in a systolic or diastolic state after the valve prosthesis is implanted, the sealing device always abuts against the autologous valve annulus, avoiding problems such as paravalvular leakage in the implanted prosthesis.

[0007] To solve the above technical problem, the present application is solved by the following technical solutions:

[0008] The technical solution adopted to solve the technical problem of the present invention is: a tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage, including a stent, artificial valve leaflets, a sealing device and an anchor. The artificial valve leaflets are arranged inside the stent, and the proximal end of the stent is fixed on the interventricular septum tissue of the patient through the anchor. The sealing device is connected to the stent. The sealing device includes a plurality of sealing rods and an elastic adaptation layer. The sealing rods are arranged in an arc structure, and the elastic adaptation layer covers or connects the free end portions of the sealing rods. After the stent is installed in place, the autologous valve annulus abuts against and fits the elastic adaptation layer, and the elastic adaptation layer can generate a compliant deformation with the expansion of the autologous valve annulus, so that the elastic adaptation layer always abuts against the autologous valve annulus.

[0009] The object of the present invention can also be further realized by the following technical solutions:

[0010] As a further improvement of the present invention, the sealing rod includes a first rod and a second rod. The first rod is arranged above the autologous valve annulus, and the second rod is arranged below the autologous valve annulus. And when the atrial wall presses the free end of the first rod, the free end of the first rod swings towards the center of the stent with the fixed point as the fulcrum, and the first rod further drives the second rod to rotate towards the atrium with the fixed point as the fulcrum.

[0011] As a further improvement of the present invention, the sealing rod can conform to the anatomical shape of the inner wall of the atrium, and the sealing rod also has a certain rigidity, so that when the atrial wall presses the free end of the first rod, the first rod drives the second rod to fold towards the distal end of the stent, so that the second rod abuts against the autologous valve annulus; that is to say, the first rod and the second rod form a seesaw-like lever with the connection point of the sealing rod and the stent as the fulcrum. When one end of the first rod is stressed, the second rod can be pried upwards to fold with the connection point as the fulcrum, so that the second rod abuts against the autologous valve annulus, achieving the effect of preventing backflow.

[0012] As a further improvement of the present invention, the elastic adaptation layer includes elastic filaments and a fabric layer. The elastic filaments are fixedly connected to the fabric layer, and the axial lengths of the elastic filaments and the fabric layer are equal.

[0013] As a further improvement of the present invention, during pre-installation, the first rod member is close to the distal end of the stent, the second rod member is close to the proximal end of the stent, and the elastic adaptation layer is stretched. After the stent is installed in place, the second rod member is folded towards the distal end of the stent, and the elastic adaptation layer fits against the autologous valve annulus. Subsequently, the first rod member is folded towards the proximal end of the stent, so that the autologous valve annulus is clamped between the first rod member and the second rod member, and the elastic adaptation layer can undergo compliant deformation with the expansion or contraction of the autologous valve annulus.

[0014] As a further improvement of the present invention, after the tricuspid valve prosthesis is implanted, when the autologous valve annulus contracts, the autologous valve annulus abuts against and fits against the elastic adaptation layer, and the elastic adaptation layer is stretched. When the autologous valve annulus expands, the elastic adaptation layer contracts, and the autologous valve annulus still adheres to the elastic adaptation layer.

[0015] As a further improvement of the present invention, the sealing rod is arranged in an arc structure. After the tricuspid valve prosthesis is implanted, the first rod member closely adheres to the autologous valve annulus and the atrial wall, and the atrial wall presses the sealing device. The first rod member drives the second rod member to fold towards the distal end of the stent, so that the second rod member closely adheres to the lower part of the autologous valve annulus.

[0016] As a further improvement of the present invention, a support rod member is provided at the distal end of the stent. The first rod member is fixedly connected to the support rod member, and the free end of the support rod member is bent and extends to the outside of the first rod member.

[0017] As a further improvement of the present invention, a flexible skirt is provided between adjacent support rod members; after the tricuspid valve prosthesis is installed in place, the free end portions of the support rod members abut against the atrial wall, and there is a flexible skirt between adjacent support rod members, and the flexible skirt can conform to and fit against the atrial wall.

[0018] As a further improvement of the present invention, a buffer structure is provided at the free end portion of the support rod member. The buffer structure can not only avoid puncturing the atrial wall, but also better conform to the atrial wall, achieving a good abutting effect and avoiding the occurrence of gaps and blood reflux.

[0019] As a further improvement of the present invention, the sealing device is provided with a first protrusion, a second protrusion and a third protrusion in the ventricular part. After the tricuspid valve prosthesis is implanted, the first protrusion, the second protrusion and the third protrusion are respectively located at the junction of the anterior leaflet and the posterior leaflet, the junction of the anterior leaflet and the septal leaflet, and the junction of the posterior leaflet and the septal leaflet, and the outer periphery of the ventricular part is coated with a fabric layer; since the regurgitation at the leaflet junction is relatively severe, the first protrusion, the second protrusion and the third protrusion can further supplement the position of the leaflet junction, so that the sealing device can be filled into the leaflet junction to avoid the occurrence of regurgitation.

[0020] As a further improvement of the present invention, in the natural state, the free end of the second rod member bends towards the distal end of the stent; the cooperation between the free end of the second rod member and the first rod member can firmly abut against the autologous annulus tissue, effectively increasing the clamping force of the sealing device on the autologous annulus and achieving a better anti-leakage effect.

[0021] Compared with the prior art, the advantages of the present application are as follows:

[0022] 1. The opening and closing of the heart valve will cause changes in the diameter of the autologous annulus. However, the existing anti-leakage devices cannot achieve compliance changes following the expansion or contraction of the autologous annulus. That is to say, when the diameter of the autologous annulus changes, the existing anti-leakage devices cannot closely adhere to the autologous annulus tissue in real time, resulting in paravalvular leakage. Different from the prior art, in an embodiment of the present invention, the stent is fixed on the ventricular septum tissue of the patient by using the anchor, which can effectively limit the axial movement of the stent, so that the stent can be firmly fixed in the heart. Moreover, the sealing device is provided with an elastic adaptation layer. After the prosthesis is implanted, the elastic adaptation layer closely adheres to the autologous annulus, and the elastic adaptation layer can achieve compliance changes with the contraction or expansion of the autologous annulus, so that the elastic adaptation layer can always adhere to the autologous annulus, thereby preventing blood from flowing back.

[0023] 2. In the prior art, in the cross-sectional direction perpendicular to the central axis of the stent, the cross-sectional area of the sealing device is larger than that of the autologous annulus, so that the sealing device can completely cover the entire autologous annulus, and the free edge part of the atrial segment should abut against the atrial wall to achieve a better anti-leakage effect. However, the inner wall surface of the atrium is not very regular and smooth. Therefore, the extrusion force of some parts of the atrial wall on the atrial segment is relatively large, resulting in wrinkles and gaps in the atrial segment, leading to blood reflux. In addition, after the prosthesis is implanted for a long time, due to the reduction of valvular regurgitation, the atrium will remodel and shrink to the size before the lesion, which will also cause excessive extrusion force of the atrial wall on the sealing device, resulting in wrinkles and gaps in the atrial segment, thereby causing blood reflux. Different from the prior art, in an embodiment of the present invention, the sealing device includes a sealing rod and an elastic adaptation layer. When the atrial wall squeezes the sealing device, its first rod member will drive the second rod member to fold towards the distal end of the stent, so that the second rod member abuts tightly against the lower part of the autologous annulus, which can effectively avoid blood reflux caused by the atrial squeezing the sealing device, resulting in wrinkles and gaps. At the same time, the sealing rod can prevent blood reflux caused by the atrial squeezing resulting in gaps in the sealing device, and the elastic adaptation layer can generate compliance changes when the autologous annulus expands, so that the elastic adaptation layer can always adhere to the autologous annulus and avoid the occurrence of reflux. The two cooperate with each other. Whether the autologous annulus is in a contracted or diastolic state, the sealing device can always closely adhere to the autologous annulus, avoiding the occurrence of paravalvular leakage.

[0024] 3. Different from the prior art, in an embodiment of the present invention, by creatively utilizing the property that the interventricular septum is relatively stationary during ventricular systole and diastole, the heart valve prosthesis is anchored to the interventricular septum through a rigid support member, restricting the axial movement of the valve prosthesis, so that even during ventricular systole and diastole, the heart valve prosthesis will not move, thereby avoiding the occurrence of paravalvular leakage or valve prosthesis detachment.

[0025] 4. Different from the prior art, in an embodiment of the present invention, the interventricular septum is the septum between the left and right ventricles. When the anchoring position of the heart valve prosthesis is set on the interventricular septum, even if there is slight bleeding caused by puncturing the interventricular septum during the anchoring process, the blood only flows from one ventricle to the other ventricle and still remains in the blood circulation system, without serious problems. However, if the anchoring position is set on the free wall of the ventricle, when there is bleeding caused by puncturing the free wall of the ventricle during the anchoring process, the blood will flow into the pericardium, leading to cardiac tamponade. Therefore, setting the anchoring position of the heart valve prosthesis on the interventricular septum reduces the doctor's operation requirements and reduces the occurrence of other symptoms caused by the implantation of the valve prosthesis.

[0026] 5. Different from the prior art, in an embodiment of the present invention, since there is no valve leaf partition at the junction of the autologous valve leaf, it is more likely to occur regurgitation. The sealing device is provided with a first protrusion, a second protrusion and a third protrusion at the ventricular part. When the prosthesis is implanted, the first protrusion, the second protrusion and the third protrusion are respectively located at the junction of the autologous valve leaf, enabling it to further fill the junction of the valve leaf, thereby preventing blood regurgitation.

[0027] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. Some of these other technical effects may be described below, and are predictable and understandable by those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] By referring to the following description in conjunction with the drawings, these features and advantages and other features and advantages of these embodiments and the manner of achieving them will become more apparent, and the embodiments of the present application can be better understood. In the drawings:

[0029] Figure 1a and 1b are the overall structural schematic diagram of the tricuspid valve prosthesis of the present invention and the schematic diagram of being fixed in the heart.

[0030] Figures 2a to 2c are the schematic diagram and principle diagram of the sealing device of the present invention, and the pre-assembly schematic diagram of the tricuspid valve prosthesis.

[0031] Figures 3a to 3d are the structural schematic diagram of the support rod member of the present invention and the structural schematic diagram of the first protrusion, the second protrusion and the third protrusion. DETAILED DESCRIPTION OF THE INVENTION

[0032] The present application will be further described in detail below in conjunction with the accompanying drawings and embodiments.

[0033] In the present application, the proximal end refers to the end close to the surgical operator, and the distal end refers to the end far from the surgical operator. Specific embodiments:

[0035] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be set forth. From these descriptions, the drawings, and the claims, other features, objects, and advantages of the present application will be apparent.

[0036] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the drawings. The illustrated embodiments may be other embodiments and can be implemented or carried out in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, features illustrated or described as part of one embodiment can be used with another embodiment to still produce additional embodiments. Accordingly, the disclosure of the present application covers such modifications and variations that fall within the scope of the appended claims and their equivalent elements.

[0037] Similarly, it can be understood that the phrases and terms used herein are for the purpose of description and should not be considered restrictive. The use of "including", "comprising", or "having" and their variants herein is intended to open - endedly include the items listed thereafter, their equivalents, and additional items.

[0038] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0039] In the present application, the "proximal end" refers to the end close to the apex of the heart, and the "distal end" refers to the end far from the apex of the heart.

[0040] First Embodiment

[0041] The tricuspid valve of the human heart has an anterior leaflet, a posterior leaflet, and a septal leaflet. The anterior leaflet, posterior leaflet, and septal leaflet are in a closed state during heart contraction. When one of the anterior leaflet, posterior leaflet, and septal leaflet cannot be properly closed in the closed state, valvular regurgitation occurs.

[0042] In the first embodiment, a tricuspid valve prosthesis fixed to the interventricular septum to prevent paravalvular leakage includes a stent 1, an artificial leaflet 2, a sealing device 3, and an anchor 4. The artificial leaflet 2 is disposed within the stent 1, as Figure 1aand 1b As shown, the proximal end of the stent 1 is fixed to the ventricular septal tissue of the patient through the anchor 4. The sealing device 3 is connected to the stent 1. The sealing device 3 includes a plurality of sealing rods 31 and an elastic adaptation layer 32. The sealing rods 31 are arranged in an arc structure. The elastic adaptation layer 32 covers or connects the free end portion of the sealing rods 31. After the stent 1 is installed in place, the autologous valve annulus abuts against and fits the elastic adaptation layer 32. Moreover, the elastic adaptation layer 32 can generate a compliant deformation with the expansion of the autologous valve annulus, so that the elastic adaptation layer 32 always abuts against the autologous valve annulus.

[0043] In the first embodiment, the sealing rod 31 includes a first rod member 311 and a second rod member 312. As Figure 1b and 2a shown, the first rod member 311 is arranged above the autologous valve annulus, and the second rod member 312 is arranged below the autologous valve annulus. Moreover, when the atrial wall presses the free end of the first rod member 311, the first rod member 311 drives the second rod member 312 to fold towards the distal end of the stent 1, so that the second rod member 312 abuts against the autologous valve annulus, as Figure 2b shown.

[0044] In the first embodiment, during preloading, the first rod member 311 abuts against the distal end of the stent 1, and the second rod member 312 abuts against the proximal end of the stent 1. As Figure 2c shown, the elastic adaptation layer 32 is stretched. After the stent 1 is installed in place, the second rod member 312 folds towards the distal end of the stent 1. Moreover, the elastic adaptation layer 32 fits the autologous valve annulus. Subsequently, the first rod member 311 folds towards the proximal end of the stent 1, so that the autologous valve annulus is clamped between the first rod member 311 and the second rod member 312. Moreover, the elastic adaptation layer 32 can generate a compliant deformation with the expansion or contraction of the autologous valve annulus.

[0045] In the first embodiment, the elastic adaptation layer 32 includes elastic filaments 321 and a fabric layer 322. As Figure 2a and 2c shown, the elastic filaments 321 are fixedly connected to the fabric layer 322. Moreover, the axial lengths of the elastic filaments 321 and the fabric layer 322 are equal.

[0046] In the first embodiment, after the tricuspid valve prosthesis is implanted, when the autologous valve annulus contracts, the autologous valve annulus abuts against and fits the elastic adaptation layer 32, and the elastic adaptation layer 32 is stretched. When the autologous valve annulus expands, the elastic adaptation layer 32 contracts. Moreover, the autologous valve annulus still adheres to the elastic adaptation layer 32.

[0047] In the first embodiment, the sealing rod 31 is arranged in an arc structure. After the tricuspid valve prosthesis is implanted, the first rod 311 closely adheres to the autologous valve annulus and the atrial wall. Moreover, the atrial wall presses the sealing device 3, and the first rod 311 drives the second rod 312 to fold towards the distal end of the stent 1, so that the second rod 312 closely adheres to the lower part of the autologous valve annulus, which can effectively avoid blood reflux caused by the atrial squeezing of the sealing device 3 resulting in wrinkles and gaps. At the same time, the sealing rod 31 can prevent blood reflux caused by the atrial squeezing resulting in gaps in the sealing device 3, and the elastic adaptation layer 32 can produce a compliant change when the autologous valve annulus expands, so that the elastic adaptation layer 32 can always fit the autologous valve annulus to avoid the occurrence of reflux. The two cooperate with each other. Whether the autologous valve annulus is in a contracted or diastolic state, the sealing device 3 can always closely adhere to the autologous valve annulus to avoid the occurrence of paravalvular leakage.

[0048] In the first embodiment, a support rod member 5 is provided at the distal end of the stent 1. The first rod 311 is fixedly connected to the support rod member 5, and the free end of the support rod member 5 is bent and extends to the outside of the first rod 311, as Figures 3a to 3c shown.

[0049] In the first embodiment, a flexible skirt 6 is provided between adjacent support rod members 5; after the tricuspid valve prosthesis is installed in place, the free end portions of the support rod members 5 abut against the atrial wall, and there is a flexible skirt 6 between adjacent support rod members 5. The flexible skirt 6 can conform to and fit the atrial wall.

[0050] In the first embodiment, a buffer structure 51 is provided at the free end portion of the support rod member 5, as Figure 3a shown. The buffer structure 51 can not only avoid puncturing the atrial wall, but also better conform to the atrial wall to achieve a good abutting effect and avoid the occurrence of gaps and blood reflux.

[0051] In the first embodiment, the sealing device 3 is provided with a first protrusion 33, a second protrusion 34 and a third protrusion 35 in the ventricular part, as Figure 3d shown. After the tricuspid valve prosthesis is implanted, the first protrusion 33, the second protrusion 34 and the third protrusion 35 are respectively located at the autologous valve leaflet junctions; since the reflux at the valve leaflet junctions is relatively severe, the first protrusion 33, the second protrusion 34 and the third protrusion 35 further supplement the valve leaflet junctions, so that the sealing device 3 can fill the valve leaflet junctions to avoid the occurrence of reflux.

[0052] In the first embodiment, in the natural state, the free end of the second rod member 312 bends towards the distal end of the bracket 1; the cooperation between the free end of the second rod member 312 and the first rod member 311 can tightly abut against the autologous annulus tissue, effectively increasing the clamping force of the sealing device 3 on the autologous annulus and achieving a better leakage prevention effect.

[0053] The above content is only a preferred embodiment of the present application. For those of ordinary skill in the art, according to the idea of the present application, there will be changes in the specific implementation manners and application scopes. The content of this specification should not be construed as a limitation to the present application.

Claims

1. A tricuspid valve prosthesis fixed to the interventricular septum to prevent paravalvular leakage, comprising a stent, artificial valve leaflets, a sealing device and an anchor. The artificial valve leaflets are arranged inside the stent, and the proximal end of the stent is fixed to the interventricular septum tissue of the patient through the anchor. The sealing device is connected to the stent, and it is characterized in that: The sealing device includes a plurality of sealing rods and an elastic adaptation layer. The sealing rods are arranged in an arc structure. The elastic adaptation layer covers or connects the free end portions of the sealing rods. After the stent is installed in place, the autologous valve annulus abuts and fits against the elastic adaptation layer. Moreover, the elastic adaptation layer can generate compliant deformation with the expansion of the autologous valve annulus, so that the elastic adaptation layer always abuts against the autologous valve annulus. The connection point between the sealing rod and the stent is a fixed point. The sealing rod includes a first rod member and a second rod member. The first rod member is arranged above the autologous valve annulus, and the second rod member is arranged below the autologous valve annulus. Moreover, when the atrial wall presses the free end of the first rod member, the free end of the first rod member swings towards the center of the stent with the fixed point as the fulcrum. Moreover, the first rod member further drives the second rod member to rotate towards the atrium with the fixed point as the fulcrum.

2. The tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage as claimed in claim 1, wherein: The elastic adaptation layer includes elastic filaments and a fabric layer. The elastic filaments are fixedly connected to the fabric layer. Moreover, the axial lengths of the elastic filaments and the fabric layer are equal.

3. The tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage as claimed in claim 1, wherein: During preloading, the first rod member abuts against the distal end of the stent, the second rod member abuts against the proximal end of the stent, and the elastic adaptation layer is stretched. After the stent is installed in place, the second rod member folds towards the distal end of the stent, and the elastic adaptation layer fits against the autologous valve annulus. Subsequently, the first rod member folds towards the proximal end of the stent, so that the autologous valve annulus is clamped between the first rod member and the second rod member. Moreover, the elastic adaptation layer can generate compliant deformation with the expansion or contraction of the autologous valve annulus.

4. The tricuspid valve prosthesis fixed to the interventricular septum to prevent paravalvular leakage as claimed in claim 1, wherein: After the tricuspid valve prosthesis is implanted, when the autologous valve annulus contracts, the autologous valve annulus abuts and fits against the elastic adaptation layer, and the elastic adaptation layer is stretched. When the autologous valve annulus expands, the elastic adaptation layer contracts. Moreover, the autologous valve annulus still adheres to the elastic adaptation layer.

5. The tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage as claimed in claim 1, wherein: The sealing rods are arranged in an arc structure. After the tricuspid valve prosthesis is implanted, the first rod member closely adheres to the autologous valve annulus and the atrial wall. Moreover, the atrial wall presses the sealing device, and the first rod member drives the second rod member to fold towards the distal end of the stent, so that the second rod member closely adheres to the lower part of the autologous valve annulus.

6. The tricuspid valve prosthesis fixed on the interventricular septum to prevent paravalvular leakage as claimed in claim 1, wherein: The distal end of the stent is provided with a support rod member. The first rod member is fixedly connected to the support rod member, and the free end of the support rod member bends and extends to the outside of the first rod member.

7. The tricuspid valve prosthesis fixed to the interventricular septum to prevent paravalvular leakage as claimed in claim 6, wherein: A flexible skirt is arranged between adjacent support rod members.

8. The tricuspid valve prosthesis fixed to the interventricular septum to prevent paravalvular leakage according to claim 1, characterized in that: The sealing device is provided with a first protrusion, a second protrusion and a third protrusion in the ventricular part. After the tricuspid valve prosthesis is implanted, the first protrusion, the second protrusion and the third protrusion are respectively located at the junctions of the autologous valve leaflets.

9. The tricuspid valve prosthesis fixed to the interventricular septum to prevent paravalvular leakage according to claim 8, characterized in that: The outer periphery of the ventricular part is covered with a fabric layer.

10. The tricuspid valve prosthesis fixed to the interventricular septum to prevent paravalvular leakage as claimed in claim 1, wherein: In the natural state, the free end of the second rod member bends towards the distal end of the stent.

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