A tricuspid valve prosthesis fixed to the interventricular septum with sealing means

Abstract

The application belongs to the field of medical devices, and particularly relates to a tricuspid valve prosthesis with a sealing device fixed on an atrioventricular septum, which comprises a stent, artificial valve leaflets, a sealing device and an anchoring member, the artificial valve leaflets are arranged in the stent, the proximal end of the stent is fixed on the atrioventricular septum tissue of a patient through the anchoring member, the sealing device comprises an atrium section, one end of the atrium section is connected to a fixed point at the distal end of the stent and extends downward to form a ventricle section which is convex to the outside of the stent, after the stent is installed in place, at least part of the atrium section is attached to the atrium wall, the native valve ring is located between the atrium section and the ventricle section, when the atrium wall extrudes the sealing device, the other end of the atrium section swings towards the center of the stent with the fixed point as a fulcrum, and the atrium section further drives the ventricle section to rotate towards the atrium direction with the fixed point as the fulcrum.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, in particular to a tricuspid valve prosthesis with sealing device fixed on the interventricular septum. BACKGROUND

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

[0003] Traditional treatment methods for mitral and tricuspid valve diseases include drug treatment for 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, the typical open chest and open heart surgery has too much invasiveness, needs to establish extracorporeal circulation, and has a high incidence of complications and infection risk. Many patients cannot tolerate the huge surgical risk and can only wait for death helplessly.

[0004] Patent CN201922307893.5 discloses an interventional artificial heart valve and medical device, comprising a valve support and an anchoring part, the valve support has a body section and a skirt section of the inflow end; the body section includes a plurality of circumferentially arranged support parts; at least part of the support parts extends radially outward and towards the inflow end direction; the anchoring part includes at least two anchor pieces; the anchor piece has a circular arc section, an auxiliary section and a connecting part; the free end of the circular arc section has a connecting part, which can be detachably connected with the connecting element; the auxiliary section is connected to the circular arc section, and the auxiliary section is arranged on the side close to the outflow end and close to the body part relative to the circular arc section, for restraining the human heart valve. The outer peripheral edge of the skirt section in the technical solution is provided with a downward structure, which is used for cooperating with the anchoring part to anchor the autologous valve ring. Although it can play a certain effect of preventing regurgitation, since the skirt section is composed of several main support rod pieces, the skirt section cannot completely fit the autologous valve ring, or after the skirt section fits the autologous valve ring, due to the large gap between the adjacent support rod pieces, the gap part will be separated from the autologous valve ring during the beating of the heart, causing serious blood regurgitation; and the regurgitation degree of the two end regions of the autologous valve leaflet and the central region of the valve leaflet is also different, for example: the regurgitation degree of the central region of the valve leaflet is greater than that of the two end regions of the valve leaflet, and the gap between the adjacent support rod pieces of the skirt section in the scheme is large, and the support rod piece does not fall on the corresponding part of the valve ring of the central region of the valve leaflet or only one or two support rod pieces fall on the corresponding part of the valve ring of the central region of the valve leaflet, which will cause the skirt section to not fit tightly enough with the corresponding part of the valve ring of the central region of the valve leaflet, and during the continuous blood pumping of the heart, a gap is easily generated between the sealing device and the heart tissue, causing regurgitation.

[0005] Therefore, the person skilled in the art is committed to developing a tricuspid valve prosthesis with a sealing device fixed on the interventricular septum, so that the valve prosthesis can tightly adhere to the autologous valve ring in real time after implantation, avoiding the problem that the atrial wall extrudes the sealing device, causing it to not tightly adhere to the autologous valve ring, and causing blood regurgitation and other problems. SUMMARY

[0006] The technical problem to be solved by the present application is to provide a tricuspid valve prosthesis with a sealing device fixed on the interventricular septum, so that the valve prosthesis can tightly adhere to the autologous valve ring in real time after implantation, avoiding the problem that the atrial wall extrudes the sealing device, causing it to not tightly adhere to the autologous valve ring, and causing blood regurgitation and other problems.

[0007] In order to solve the above technical problems, the present application solves the above technical problems by the following technical scheme:

[0008] According to one aspect of the present application, a tricuspid valve prosthesis with a sealing device fixed on an interventricular septum comprises a stent, an artificial valve leaflet, a sealing device and an anchor, the artificial valve leaflet is arranged in the stent, and the proximal end of the stent is fixed on the interventricular septum tissue of a patient through the anchor, the sealing device comprises an atrial segment, one end of the atrial segment is connected to a fixed point at the distal end of the stent and extends downward to form a ventricular segment which is convex to the outside of the stent, after the stent is installed in place, at least part of the atrial segment is attached to the atrial wall, the native valve ring is located between the atrial segment and the ventricular segment, when the atrial wall extrudes the sealing device, the other end of the atrial segment swings toward the center of the stent with the fixed point as a fulcrum, and the atrial segment further drives the ventricular segment to rotate toward the atrium with the fixed point as a fulcrum.

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

[0010] As a further improvement of the present application, after the tricuspid valve prosthesis is implanted, the atrial segment is tightly attached to the native valve ring and the atrial wall, and the atrial wall extrudes the free edge of the atrial segment, the free edge of the atrial segment is folded toward the center of the stent, further, the atrial segment drives the ventricular segment to fold toward the distal end of the stent and tightly attach to the lower part of the native valve ring, which can effectively prevent the blood in the ventricle from flowing to the atrium, thereby effectively preventing paravalvular leakage.

[0011] As a further improvement of the present application, the atrial segment can conform to the anatomical morphology of the atrial wall, and the atrial segment also has a certain rigidity, so that when the atrial wall extrudes the sealing device, the atrial wall drives the other end of the atrial segment to move closer to the center of the stent, and the atrial segment drives the ventricular segment to fold toward the distal end of the stent with the fixed point as a fulcrum.

[0012] As a further improvement of the present application, a flexible fabric layer is provided between the atrial segment and the ventricular segment, after the tricuspid valve prosthesis is implanted, the native valve ring is attached to the fabric layer, and when the atrium contracts, the atrial wall extrudes the sealing device, the other end of the atrial segment drives the fabric layer to pull the ventricular segment upward, so that the ventricular segment folds toward the distal end of the stent and tightly attaches to the native valve ring.

[0013] As a further improvement of the present application, the flexible fabric layer can use polyester fabric with good extensibility, so that after the native valve ring is attached to the fabric layer, there is a certain elastic space, which ensures that the native valve ring can be tightly attached to the fabric layer in real time, preventing paravalvular leakage during heart movement.

[0014] As a further improvement of the application, the sealing device is arranged in an arc structure on the cross section where the axis of the stent is located; the arc structure facilitates clamping the native annulus, and the arc structure can make the atrial segment fold upward to drive the ventricular segment to fold upward after the atrial segment is forced to fold, so that the ventricular segment can be tightly attached to the lower part of the native annulus.

[0015] As a further improvement of the application, the atrial segment of the sealing device is configured to be adapted to abut against the native annulus and the atrial wall tissue, and the cross-sectional area of the atrial segment is greater than that of the native annulus on the cross section perpendicular to the axis of the stent.

[0016] As a further improvement of the application, the ventricular segment is provided with a first protrusion, a second protrusion and a third protrusion, which are respectively located at the junctions of the native leaflets after the tricuspid prosthesis is implanted. Since the junctions of the leaflets are more prone to regurgitation due to the absence of the native leaflets, the ventricular segment is provided with the first protrusion, the second protrusion and the third protrusion at the junctions of the adjacent leaflets to further fill the junctions of the leaflets and prevent blood regurgitation.

[0017] As a further improvement of the application, the first protrusion is arranged at the junction of the anterior leaflet and the posterior leaflet, the second protrusion is arranged at the junction of the anterior leaflet and the septal leaflet, and the third protrusion is arranged at the junction of the posterior leaflet and the septal leaflet.

[0018] As a further improvement of the application, the distal end of the stent is provided with a first rod, a second rod and a third rod, and the first rod, the second rod and the third rod are respectively located on the corresponding native annulus at the junctions of the native leaflets; the first rod, the second rod and the third rod are respectively axially corresponding to the positions of the first protrusion, the second protrusion and the third protrusion, which can further compensate for the positions of the junctions of the leaflets to avoid regurgitation at the junctions of the leaflets.

[0019] As a further improvement of the application, the free ends of the first rod, the second rod and the third rod extend to the outside of the atrial segment, and the free ends of the first rod, the second rod and the third rod are bent towards the distal end of the stent to abut against the atrial wall; since the regurgitation at the junctions of the leaflets is relatively serious, the free ends of the first rod, the second rod and the third rod extend to the outside of the atrial segment to further compensate for the positions of the junctions of the leaflets in cooperation with the first protrusion, the second protrusion and the third protrusion, so that the sealing device can fill the junctions of the leaflets to avoid regurgitation.

[0020] As a further improvement of the application, the free end portions of the first rod, the second rod and the third rod are provided with a buffer structure, which not only avoids injuring the atrial wall, but also better conforms to the atrial wall to achieve good abutment effect and avoid gaps and blood regurgitation.

[0021] As a further improvement of the present application, a flexible skirt is arranged between the first, second and third rods; after the tricuspid valve prosthesis is installed in place, the first, second and third rods abut against the atrial wall, and the flexible skirt is arranged between adjacent rods, which can conform to and abut against the atrial wall.

[0022] As a further improvement of the present application, in a natural state, the free end of the ventricular segment is curved towards the distal end of the stent; the free end of the ventricular segment cooperates with the atrial segment to tightly abut against the native valve annulus tissue, effectively increasing the clamping force of the sealing device on the native valve annulus, and achieving better leak prevention effect.

[0023] According to another aspect of the present application, a tricuspid valve prosthesis with a sealing device fixed on the interventricular septum comprises a stent, artificial valve leaflets, a sealing device and an anchor, the artificial valve leaflets are arranged in 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 comprises an atrial segment and a ventricular segment, and the distal end of the stent is provided with a support rod, wherein the atrial segment is fixedly connected with the support rod, at least part of the atrial segment abuts against the atrial wall after the stent is installed in place, the native valve annulus is located between the atrial segment and the ventricular segment, and when the atrial wall extrudes the sealing device, the free end of the support rod is drawn towards the center of the stent, and the ventricular segment is folded towards the distal end of the stent.

[0024] Compared with the prior art, the present application has the following advantages:

[0025] 1. 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 native valve annulus, so that the sealing device can completely cover the entire native valve annulus, and the free edge part of the atrial segment abuts against the atrial wall, so as to achieve a better leak prevention effect. However, the inner wall surface of the atrium is not very regular and smooth, so the extrusion force of the atrial wall on the atrial segment is larger at some positions, which causes the atrial segment to wrinkle and gaps to appear, resulting in blood reflux. In addition, after the prosthesis is implanted for a long time, the atrium will be reconstructed and reduced to the size before the disease, which also causes the extrusion force of the atrial wall on the sealing device to be too large, causing the atrial segment to wrinkle and gaps to appear, thereby causing blood reflux. In an embodiment of the present application, the stent is fixed on the interventricular septum tissue of the patient by the anchor, which can effectively limit the axial movement of the stent, so that the stent can be firmly fixed in the heart. In addition, the sealing device comprises an atrial segment and a ventricular segment, when the atrial segment is extruded by the atrial wall, the ventricular segment will fold towards the distal end of the stent with the fixed point as the fulcrum and abut tightly below the native valve annulus, effectively avoiding the gaps caused by the extrusion of the atrial wall on the atrial segment, and preventing paravalvular leakage.

[0026] 2. In an embodiment of the present application, different from the prior art, the applicant discovers that there is a large depression between the free wall of the right ventricle and the annulus of the tricuspid valve, and the degree of depression varies among different patients, resulting in different anchoring positions for different patients, which makes it difficult to ensure the anchoring effect. According to the discovered characteristics of the heart structure, the applicant designs the technical solution of the present application. When the technical solution of the present application is applied to the tricuspid valve, it can make good use of the flatness of the septal leaflet of the tricuspid valve and the interventricular septum to fix the heart valve prosthesis through the interventricular septum, thereby solving the problem of difficult anchoring due to different degrees of depression between the free wall of the patient's ventricle and the septal leaflet, reducing the difficulty of anchoring when the tricuspid valve is implanted, and improving the reliability of implanting the valve prosthesis.

[0027] 3. In an embodiment of the present application, different from the prior art, the pressure difference of the atrioventricular valve is large. The applicant creatively uses the characteristic that the thickness of the muscle fiber tissue of the interventricular septum is greater than that of the free wall of the ventricle to fix the heart valve prosthesis through the interventricular septum, thereby avoiding the occurrence of serious symptoms such as heart rupture caused by anchoring the heart valve prosthesis on the fragile free wall of the left ventricle.

[0028] 4. In an embodiment of the present application, different from the prior art, a flexible fabric layer is arranged between the atrial segment and the ventricular segment, and the fabric layer has good ductility, so that the autologous annulus can have a certain elastic space after being attached to the fabric layer, thereby ensuring that the autologous annulus can be attached to the fabric layer in real time and preventing paravalvular leakage during heart movement.

[0029] 5. In an embodiment of the present application, different from the prior art, since there is no leaflet barrier at the junction of the autologous leaflet, regurgitation is more likely to occur. The ventricular segment is provided with a first protrusion, a second protrusion and a third protrusion. After the prosthesis is implanted, the first protrusion, the second protrusion and the third protrusion are respectively located at the junction of the autologous leaflet, so as to further fill the junction of the leaflet, thereby preventing blood regurgitation.

[0030] 6. In an embodiment of the present application, different from the prior art, the distal end of the stent is provided with a first rod, a second rod and a third rod, which not only can increase the anchoring force of the stent in the atrium, but also can cooperate with the protrusions of the ventricular segment to further compensate the position of the junction of the leaflet, thereby avoiding regurgitation at the junction of the leaflet.

[0031] 7. In an embodiment of the present application, different from the prior art, the distal end of the stent is provided with a support rod, and the atrial segment of the sealing device is fixedly connected with the support rod. After the prosthesis is implanted, the autologous annulus is clamped between the atrial segment and the ventricular segment. When the atrial wall squeezes the sealing device, the free end of the support rod moves towards the center of the stent, and the ventricular segment is folded towards the distal end of the stent and attached to the lower side of the autologous annulus, thereby effectively avoiding the occurrence of gaps due to the folding of the atrial segment caused by the squeezing of the atrium, and preventing paravalvular leakage.

[0032] Embodiments of the application can achieve other advantageous technical effects not all listed, which are described in part below and are expected and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF DRAWINGS

[0033] The above-mentioned features and advantages of the embodiments, and other features and advantages of the embodiments, as well as means for materializing them, will become more apparent with reference to the following description and the accompanying drawings, wherein:

[0034] Figures la-lc The schematic diagram of the overall structure of the tricuspid valve prosthesis of the application and the position of the tricuspid valve prosthesis arranged at the annulus.

[0035] Figures 2a-2d The schematic diagram of the specific structure of the atrial segment, the ventricular segment, and the stent of the application.

[0036] Figures 3a-3c The schematic diagram of the atrial wall being extruded, the ventricular segment being folded towards the distal end of the stent and being closely attached to the native annulus. Figure 3c The arrow in the figure means blood, and the distal end of the ventricular segment blocks the blood flow towards the atrium.

[0037] Figure 4a And 4b Another embodiment of the application. DETAILED DESCRIPTION

[0038] The application will be described in further detail below in conjunction with the accompanying drawings and embodiments.

[0039] The proximal end described in the application refers to the end close to the surgical operator, and the distal end described in the application refers to the end away from the surgical operator. Specific embodiments:

[0041] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the application will be set forth. From these descriptions, drawings, and claims, other features, objects, and advantages of the application can be apparent.

[0042] It is to be understood that the embodiments illustrated and described are not intended to be limited to the details shown, since the techniques explicitly included in the present disclosure are comprehensive and will be apparent to those skilled in the art. The illustrated embodiments can be implemented or executed in a variety of ways, and can be implemented or performed with other structures and methods. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, various modifications and changes can be made to the embodiments disclosed herein without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment, can be used with another embodiment, to yield still a further embodiment. Thus, it is intended that the disclosure encompass such modifications and changes and that the disclosure is limited only by the scope of the appended claims and their equivalents.

[0043] Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and not of limitation. The use of terms such as "including" or "comprising" or "having" and variations thereof throughout this disclosure are meant to encompass the item listed thereafter and equivalents thereof as well as additional items.

[0044] The present application will be described in greater detail by reference to various embodiments and examples of aspects of the present application.

[0045] 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 away from the apex of the heart.

[0046] First Embodiment

[0047] The tricuspid valve of the human heart has an anterior leaflet, a posterior leaflet, and a septal leaflet. The anterior leaflet, the posterior leaflet, and the septal leaflet are in a closed state when the heart contracts, and when one of the anterior leaflet, the posterior leaflet, and the septal leaflet cannot normally close in the closed state, i.e., valve regurgitation occurs.

[0048] In the first embodiment, a tricuspid valve prosthesis having a sealing device 3, as shown in FIG. 1, includes a stent 1, an artificial leaflet 2, a sealing device 3, and an anchor 4, the artificial leaflet 2 is disposed in the stent 1, as shown in FIG. 2. Figures la-lc Figure 2d ​As shown, and the proximal end of the stent 1 is fixed on the patient's interventricular septum tissue through the anchor 4, the sealing device 3 comprises an atrial segment 31, one end of the atrial segment 31 is connected to the fixed point 32 located at the distal end of the stent 1, and extends downward to form a ventricular segment 33 which is convex to the outside of the stent 1, after the stent 1 is installed in place, at least part of the atrial segment 31 is attached to the atrial wall, the native valve ring is located between the atrial segment 31 and the ventricular segment 33, when the atrial wall squeezes the sealing device 3, the atrial wall drives the other end of the atrial segment 31 to move towards the center of the stent 1, and the atrial segment 31 drives the ventricular segment 33 to fold towards the distal end of the stent 1 and tightly attach to the lower side of the native valve ring with the fixed point 32 as the fulcrum, effectively avoiding the gap caused by the folding of the atrial segment 31 due to the squeezing of the atrium, and preventing paravalvular leakage.

[0049] More details of the embodiment of the anchor 4 (also known as "anchor needle", "anchor pin", etc.) in this embodiment are described in detail in the patent application No. 202120566797.7 of the same applicant, the content of which is incorporated by reference into the present application; the proximal end of the stent 1 is fixed on the patient's interventricular septum through the anchor needle, this kind of anchoring method can avoid the relative axial movement of the stent 1, and after the stent 1 is implanted, the sealing device 3 will relatively displace radially, and during the radial shaking, the atrial wall will squeeze the atrial segment 31, at this time, the ventricular segment 33 will be raised upwards and tightly attached to the lower side of the native valve ring, avoiding blood regurgitation, as shown in Figures 3a-3c

[0050] However, after the stent 1 is implanted, it will displace radially with the beating of the heart, resulting in that the sealing device 3 cannot tightly attach to the native valve ring or the atrial tissue, thereby causing regurgitation.

[0051] In the first embodiment, when the tricuspid valve prosthesis is implanted, the atrial segment 31 tightly attaches to the native valve ring and the atrial wall, and the atrial wall squeezes the free edge of the atrial segment 31, the free edge of the atrial segment 31 is folded towards the center of the stent 1, further, the atrial segment 31 drives the ventricular segment 33 to fold towards the distal end of the stent 1 and tightly attach to the lower side of the native valve ring, which can effectively prevent the blood in the ventricle from flowing to the atrium, thereby effectively preventing paravalvular leakage.

[0052] ​In this first embodiment, a flexible fabric layer 5 is provided between the atrial segment 31 and the ventricular segment 33. After the tricuspid valve prosthesis is implanted, the autologous valve annulus adheres to the fabric layer 5. Furthermore, when the atrium contracts, the atrial wall compresses the sealing device 3, and the other end of the atrial segment 31 pulls the fabric layer 5 upwards, causing the ventricular segment 33 to fold towards the distal end of the stent 1 and adhere tightly to the autologous valve annulus. The flexible fabric layer 5 can be made of polyester fabric with good extensibility, allowing for a certain amount of elastic space after the autologous valve annulus adheres to the fabric layer 5, ensuring that the autologous valve annulus can adhere tightly to the fabric layer 5 in real time, preventing paravalvular leakage during cardiac motion. Figure 3c As shown.

[0053] In this first embodiment, the sealing device 3 is arranged in an arc shape on the cross section where the central axis of the support 1 is located. The arc shape facilitates clamping the autologous valve annulus, and the arc shape allows the atrial segment 31 to bend under force and drive the ventricular segment 33 to bend upward, so that the ventricular segment 33 can be closely attached to the lower part of the autologous valve annulus.

[0054] In this first embodiment, the atrial segment 31 of the sealing device 3 is configured to abut against the autologous valve annulus and atrial wall tissue, and the cross-sectional area of ​​the atrial segment 31 is larger than the cross-sectional area of ​​the autologous valve annulus in a cross-section perpendicular to the central axis of the stent 1.

[0055] In this first embodiment, the ventricular segment 33 is provided with a first protrusion 331, a second protrusion 332, and a third protrusion 333, as follows: Figure 2b As shown, after the tricuspid valve prosthesis is implanted, the first protrusion 331, the second protrusion 332, and the third protrusion 333 are located at the junction of the leaflets. Since regurgitation is more likely to occur at the junction of the leaflets without the obstruction of the leaflets, the ventricular segment 33 is specifically designed with the first protrusion 331, the second protrusion 332, and the third protrusion 333 at the junction of adjacent leaflets, so that they can further fill the junction of the leaflets, thereby preventing blood regurgitation.

[0056] In this first embodiment, the first protrusion 331 is located at the junction of the anterior and posterior leaflets, the second protrusion 332 is located at the junction of the anterior and septal leaflets, and the third protrusion 333 is located at the junction of the posterior and septal leaflets.

[0057] In this first embodiment, the distal end of the bracket 1 is provided with a first rod 311, a second rod 312, and a third rod 313, as follows: Figure 2aThe first rod 311, the second rod 312 and the third rod 313 are respectively located on the corresponding native valve annulus at the junction of the valve leaflets, and the positions of the first rod 311, the second rod 312 and the third rod 313 axially correspond to the positions of the first protrusion 331, the second protrusion 332 and the third protrusion 333, which can further compensate the positions of the junction of the valve leaflets to avoid regurgitation at the junction of the valve leaflets.

[0058] The free ends of the first rod 311, the second rod 312 and the third rod 313 extend to the outside of the atrium section 31, and the free ends of the first rod 311, the second rod 312 and the third rod 313 are bent to the distal end direction of the stent 1 to be suitable for abutting the atrium wall. Since the regurgitation at the junction of the valve leaflets is relatively serious, the free ends of the first rod 311, the second rod 312 and the third rod 313 extend to the outside of the atrium section 31, which can cooperate with the first protrusion 331, the second protrusion 332 and the third protrusion 333 to further compensate the junction of the valve leaflets, so that the sealing device 3 can fill the junction of the valve leaflets to avoid the occurrence of regurgitation.

[0059] In the first embodiment, the free end part of the first rod 311, the second rod 312 and the third rod 313 is provided with a buffer structure 315, as shown in the figure. Figure 2c The buffer structure 315 can not only avoid scratching the atrium wall, but also better conform to the atrium wall to achieve good abutting effect and avoid gaps and blood regurgitation.

[0060] In the first embodiment, a flexible skirt 314 is arranged between the first rod 311, the second rod 312 and the third rod 313. After the tricuspid prosthesis is installed in place, the first rod 311, the second rod 312 and the third rod 313 abut the atrium wall, and there is a flexible skirt 314 between the adjacent rods. The flexible skirt 314 can conform to and abut the atrium wall.

[0061] In the first embodiment, in a natural state, the free end of the ventricle section 33 is bent to the distal end direction of the stent 1. The free end of the ventricle section 33 cooperates with the atrium section 31 to tightly abut the native valve annulus tissue, effectively increases the clamping force of the sealing device 3 on the native valve annulus, and achieves better leakage prevention effect.

[0062] Second embodiment

[0063] The second embodiment is basically the same as the first embodiment. The difference is that in the second embodiment, the distal end of the stent 1 is provided with a support rod 6, and the atrium section 31 of the sealing device 3 is fixedly connected with the support rod 6.

[0064] A tricuspid valve prosthesis with sealing device 3, comprising a stent 1, artificial valve leaflets 2, sealing device 3 and anchoring member 4, the artificial valve leaflets 2 are arranged in the stent 1, and the proximal end of the stent 1 is fixed on the patient's interventricular septal tissue through the anchoring member 4, the sealing device 3 comprises an atrial segment 31 and a ventricular segment 33, the distal end of the stent 1 is provided with a support rod 6, wherein the atrial segment 31 is fixedly connected with the support rod 6, after the stent 1 is installed in place, at least part of the atrial segment 31 is attached to the atrial wall, the native valve ring is located between the atrial segment 31 and the ventricular segment 33, when the atrial wall extrudes the sealing device 3, the free end of the support rod 6 is close to the center of the stent 1, and the ventricular segment 33 is folded and attached to the lower part of the native valve ring in the direction of the distal end of the stent 1, effectively avoiding the gap caused by the folding of the atrial segment 31 due to the extrusion of the atrium, preventing the occurrence of paravalvular leakage, as shown in Figure 4a and 4b .

[0065] In the second embodiment, the tricuspid valve prosthesis is also provided with a clamping member 7 for clamping the native valve leaflets.

[0066] The remaining structure and concept of the second embodiment are similar to those of the first embodiment, and therefore will not be described again here.

[0067] The above is only the preferred embodiment of the present application, and for those skilled in the art, according to the idea of the present application, the specific implementation and application range can be changed, and the content of the description should not be understood as the limitation of the present application.

Claims

1. A tricuspid valve prosthesis fixed on the interventricular septum with a sealing device, comprising a stent, artificial valve leaflets, a sealing device and an anchoring member, the artificial valve leaflets are arranged in the stent, and the proximal end of the stent is fixed on the interventricular septum tissue of the patient through the anchoring member, characterized in that: the sealing device comprises an atrial segment, one end of the atrial segment is connected to a fixed point at the distal end of the stent, and extends downward to form a ventricular segment which protrudes outward of the stent, after the stent is installed in place, at least part of the atrial segment is attached to the atrial wall, the native valve annulus is located between the atrial segment and the ventricular segment, when the atrial wall squeezes the sealing device, the other end of the atrial segment swings towards the center of the stent with the fixed point as the fulcrum, and the atrial segment further drives the ventricular segment to rotate towards the atrium with the fixed point as the fulcrum. wherein 2. The tricuspid valve prosthesis fixed on the interventricular septum with a sealing device according to claim 1, characterized in that: the sealing device is arranged in an arc structure on the cross section where the axis of the stent is located.

3. The tricuspid valve prosthesis fixed on the interventricular septum with a sealing device according to claim 1, characterized in that: the atrial segment of the sealing device is configured to be suitable for attaching to the native valve annulus and the atrial wall tissue, and the cross-sectional area of the atrial segment is larger than that of the native valve annulus on the cross section perpendicular to the axis of the stent.

4. The tricuspid valve prosthesis fixed on the interventricular septum with a sealing device according to claim 1, characterized in that: the ventricular segment is provided with a first protrusion, a second protrusion and a third protrusion, and the first protrusion, the second protrusion and the third protrusion are respectively located at the junction of the native valve leaflets after the tricuspid valve prosthesis is implanted. wherein 5. The tricuspid valve prosthesis fixed on the interventricular septum with a sealing device according to claim 4, characterized in that: the distal end of the stent is provided with a first rod member, a second rod member and a third rod member, and the first rod member, the second rod member and the third rod member are respectively located on the corresponding native valve annulus at the junction of the native valve leaflets.

6. The tricuspid valve prosthesis fixed on the interventricular septum with a sealing device according to claim 5, characterized in that: the free ends of the first rod member, the second rod member and the third rod member extend to the outside of the atrial segment, and the free ends of the first rod member, the second rod member and the third rod member are bent towards the distal end of the stent to be suitable for attaching to the atrial wall. wherein 7. The tricuspid valve prosthesis fixed on the interventricular septum with a sealing device according to claim 6, characterized in that: flexible skirts are provided between the first rod member, the second rod member and the third rod member.

8. The tricuspid valve prosthesis fixed on the interventricular septum with a sealing device according to claim 1, characterized in that: wherein ​ ​ wherein, ​ ​ wherein ​ ​ wherein ​ ​ wherein In a natural state, the free end of the ventricular segment is curved toward the distal end of the stent.

9. A tricuspid prosthesis fixed on the interventricular septum with a sealing device, comprising a stent, artificial valve leaflets, a sealing device and an anchor, the artificial valve leaflets are arranged in the stent, and the proximal end of the stent is fixed on the interventricular septum tissue of the patient through the anchor, characterized in that: the sealing device comprises an atrial segment and a ventricular segment, the distal end of the stent is provided with a support rod, wherein the atrial segment is fixedly connected with the support rod, at least part of the atrial segment is attached to the atrial wall after the stent is installed in place, the native valve annulus is located between the atrial segment and the ventricular segment, when the atrial wall extrudes the sealing device, the free end of the support rod is close to the center of the stent, and the ventricular segment is folded toward the distal end of the stent, a flexible fabric layer is arranged between the atrial segment and the ventricular segment, the native valve annulus is attached to the fabric layer after the tricuspid prosthesis is implanted, and when the atrium contracts, the atrial wall extrudes the sealing device, the other end of the atrial segment pulls the fabric layer to lift the ventricular segment, so that the ventricular segment is folded toward the distal end of the stent and tightly attached to the native valve annulus.

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