Artificial valve prosthesis with sealing device

Abstract

The present application belongs to the field of medical devices, and specifically relates to an artificial valve prosthesis with a sealing device, comprising a stent, an artificial valve leaflet and a sealing device, wherein the artificial valve leaflet is arranged in the stent, and the sealing device is at least partially arranged outside the stent, the sealing device comprises a sealing frame and a leak-proof component connected to the sealing frame, the sealing frame is connected to the stent, and the stent provides a fulcrum for the sealing frame, the sealing frame comprises a first curved segment and a second curved segment, after the stent is installed in place, at least a portion of the first curved segment is in contact with the heart tissue wall, when the heart tissue squeezes the sealing device, the first curved segment rotates around the fulcrum toward the center of the stent, and the first curved segment drives the second curved segment to rotate in the same direction, so that the sealing device is always in contact with the native valve ring to prevent the problem of paravalvular leakage.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to an artificial valve prosthesis with a sealing device. Background Art

[0002] From the perspective of heart structure, whether it is the mitral valve, tricuspid valve, or aortic valve, they all have special physiological structures, making it very difficult to accurately position and fix the product. In particular, the position of the mitral valve in the heart and its complex anatomical structure pose great challenges to mitral valve replacement. Mitral valve regurgitation is the most common mitral valve disease. There are usually two treatment methods for mitral valve regurgitation patients: repair and replacement. Repair is the first and best method, but in fact, many dysfunctional valves cannot be treated by repair methods. At this time, mitral valve replacement (MVR) is required.

[0003] Patent CN109199640B discloses an artificial valve prosthesis, including a stent and a valve, wherein the stent includes a valve sewing section and an atrial section, the valve is fixedly connected to the valve sewing section, the valve sewing section is connected to the atrial section, the atrial section is composed of radial rod-shaped support members, the rod-shaped support members include two main support members and at least one auxiliary support member, one end of the rod-shaped support member is fixedly connected to the valve sewing section as a fixed end, the other end of the rod-shaped support member is free as a free end, a flexible skirt is arranged between adjacent rod-shaped support members, the atrial section can adapt to a D-shaped structure when it is fully released, and the connecting line of the free ends of the main support members constitutes the The straight section of the D-shaped structure, the free end of the auxiliary support member is located on the arc section of the D-shaped structure. The technical defects of this solution are: the atrial segment is formed by the support member and the skirt, the skirt fits the atrial wall to prevent paravalvular leakage, the skirt is composed of memory alloy wire and a coating, the atrium will squeeze the skirt during contraction and relaxation, causing the memory alloy wire to deform, resulting in wrinkles on the skirt, which cannot completely fit the native valve ring, resulting in paravalvular leakage. In particular, the artificial valve prosthesis of this application has an eccentric structure, so that the anterior valve area corresponding to the skirt is larger than the posterior valve area. The large area of ​​the skirt makes its adhesion worse, and more serious paravalvular leakage will occur.

[0004] Patent CN212522083U discloses a heart valve, including a valve support, a flow blocker and a valve leaflet, wherein the flow blocker and the valve leaflet are arranged on the valve support, and the flow blocker includes a first flow blocker and a second flow blocker, wherein the first flow blocker is arranged on the inner surface of the valve support, or the first flow blocker is arranged on the outer surface of the valve support, or the first flow blocker is arranged on the inner surface and the outer surface of the valve support; the second flow blocker is arranged on the outer surface of the valve support and is located on the outer surface of the first flow blocker, and the second flow blocker is arranged on the outer surface of the valve support. A viscous layer for slowing down the blood flow rate is arranged on the surface away from the first baffle membrane. The technical defect of this solution is that the heart valve prevents paravalvular leakage by means of the first baffle membrane and the second baffle membrane. The surface of the second group of flow membranes is provided with a viscous layer for slowing down the blood flow rate. After a period of time, the blood flow coagulates on the viscous layer to form a thrombus, which fills the gap between the surface of the heart valve and the heart tissue, thereby blocking the paravalvular blood flow. However, the atrium will squeeze the second baffle membrane during contraction and relaxation, and the thrombus will rub against the second baffle membrane, and there is a risk of the thrombus being displaced following the movement of the blood flow.

[0005] Therefore, technicians in this field are committed to developing an artificial valve prosthesis with a sealing device, so that the valve prosthesis can be closely attached to the native valve ring in real time after implantation, avoiding problems such as paravalvular leakage caused by the atrial wall squeezing the stent or the sealing device during heart beating, resulting in the sealing device being unable to fit closely to the native valve ring.

[0006] Application Contents

[0007] The technical problem to be solved by the present invention is to provide an artificial valve prosthesis with a sealing device, so that the valve prosthesis can be closely attached to the native valve ring in real time after implantation, avoiding the problem that the sealing device cannot be closely attached to the native valve ring when squeezed by the atrial wall, resulting in paravalvular leakage and the like.

[0008] In order to solve the above technical problems, the present application is solved by the following technical solutions:

[0009] An artificial valve prosthesis with a sealing device comprises a stent, an artificial valve leaflet and a sealing device, wherein the artificial valve leaflet is arranged in the stent, and the sealing device is at least partially arranged outside the stent. The sealing device comprises a sealing frame and a leak-proof component connected to the sealing frame, the sealing frame is connected to the stent, and the stent provides a fulcrum for the sealing frame, the sealing frame comprises a first curved segment and a second curved segment, after the stent is installed in place, at least a portion of the first curved segment is in contact with the heart tissue wall, when the heart tissue squeezes the sealing device, the first curved segment rotates around the fulcrum toward the center of the stent, and the first curved segment drives the second curved segment to rotate in the same direction.

[0010] The purpose of the present invention can be further achieved by the following technical solutions:

[0011] According to an embodiment, the leakage-proof component includes a first leakage-proof film, and the first leakage-proof film covers the surfaces of the first curved section and the second curved section.

[0012] According to one embodiment, after the artificial valve prosthesis is implanted, the first curved segment is in close contact with the native valve ring and the atrial wall; and when the atrial wall squeezes the sealing device, the second curved segment rotates toward the distal end of the stent and is in close contact with the native valve ring, effectively preventing the blood in the ventricle from flowing to the atrium and solving the paravalvular leakage problem.

[0013] According to one embodiment, the first curved section is connected to the distal portion of the stent.

[0014] According to one embodiment, the leak-proof component includes a second leak-proof membrane, one end of which is connected to the first curved segment or the second curved segment, and the other end is also connected to the first curved segment or the second curved segment; and the second leak-proof membrane is flexible, and after the stent is released, the second leak-proof membrane fits with the autologous valve ring.

[0015] According to one embodiment, both ends of the second anti-leakage membrane are connected to the first curved section.

[0016] According to one embodiment, both ends of the second anti-leakage membrane are connected to the second curved section.

[0017] According to one embodiment, the distal end of the second leak-proof membrane is connected to the first curved segment, the proximal end of the second leak-proof membrane is connected to the second curved segment, and the second leak-proof membrane is not elastic. When the first curved segment rotates upward, the first curved segment can drive the second leak-proof membrane to lift the second curved segment.

[0018] According to one embodiment, the second anti-leakage membrane can be made of polyester cloth with excellent extensibility.

[0019] According to an embodiment, the leakage-proof component comprises a third leakage-proof membrane, one end of the third leakage-proof membrane is connected to the second curved section, and the other end is free.

[0020] According to one embodiment, after the artificial valve prosthesis is implanted, when the left ventricle is squeezed, the blood flow impacts the third leak-proof membrane, so that the third leak-proof membrane is closely attached to the lower side of the mitral valve ring.

[0021] According to one embodiment, the third anti-leakage membrane is connected to the outer periphery of the second curved segment.

[0022] According to one embodiment, after the artificial valve prosthesis is implanted, the first curved segment is in close contact with the native valve ring and the atrial wall; and when the atrial wall squeezes the sealing device, the second curved segment rotates toward the distal end of the stent and is in close contact with the native valve ring.

[0023] According to one embodiment, the two ends of the second leak-proof membrane are respectively connected to the first curved segment and the second curved segment. After the artificial valve prosthesis is implanted, the autologous valve ring fits the second leak-proof membrane, and when the atrium contracts, the atrial wall squeezes the sealing device, and the free end of the first curved segment drives the second leak-proof membrane to pull the second curved segment upward, so that the second curved segment rotates toward the distal end of the stent and fits tightly to the autologous valve ring.

[0024] According to one embodiment, the first curved section and the second curved section are connected in one piece; and the first curved section and the second curved section are in a "tiger's mouth" shape at the connection point.

[0025] According to one embodiment, the overall bending direction of the second bending section is toward the distal direction.

[0026] According to one embodiment, the stent includes a main body segment and an atrial segment, the atrial segment includes a plurality of fitting rods, and the fitting rods are connected to the first curved segment; and, on the cross-section where the central axis of the stent is located, the shape of the fitting rods is substantially the same as the shape of the first curved segment, and both are arc-shaped.

[0027] According to one embodiment, the second curved section includes an arc portion and a convex portion. When the artificial valve prosthesis is implanted, the convex portion is located at the junction of the native valve leaflets.

[0028] According to one embodiment, the second curved section comprises two protrusions, and the protrusions are located at the junction of the anterior leaflet and the posterior leaflet of the mitral valve after the valve prosthesis is installed.

[0029] According to one embodiment, the second curved section includes three protrusions, which are respectively located at the junction of the anterior leaflet and the posterior leaflet of the tricuspid valve, the junction of the anterior leaflet and the septal leaflet, and the junction of the posterior leaflet and the septal leaflet after the valve prosthesis is installed.

[0030] According to one embodiment, the sealing device also includes an elastic wire, which is fixedly connected to the second leak-proof membrane. The second leak-proof membrane and the elastic wire are combined to form an elastic adaptive segment. The elastic adaptive segment produces compliant deformation as the autologous valve ring expands and contracts, and the elastic adaptive segment is always in contact with the autologous valve ring.

[0031] According to one embodiment, during pre-installation, the first curved segment is attached to the distal end of the stent, the second curved segment is attached to the proximal end of the stent, and the elastic adaptive segment is stretched. When the stent is installed in place, the second curved segment is rotated toward the distal end of the stent, and the elastic adaptive segment fits the autologous valve ring. Subsequently, the first curved segment is rotated toward the proximal end of the stent, so that the autologous valve ring is clamped between the first curved segment and the second curved segment.

[0032] According to one embodiment, during pre-installation, the elastic thread is straightened, and the length of the elastic thread is equal to the axial length of the second anti-leakage membrane.

[0033] According to one embodiment, the elastic wire is a shape memory alloy.

[0034] According to one embodiment, when the atrial wall squeezes the sealing device, the first curved segment rotates toward the center line of the stent, and at the same time, the first curved segment drives the second curved segment to rotate toward the distal end of the stent.

[0035] According to one embodiment, the first curved segment is connected to the atrium segment, and the second curved segment is connected to the outer surface of the main body segment.

[0036] According to one embodiment, during pre-installation, the first curved segment is attached to the distal end of the stent, the second curved segment is attached to the proximal end of the stent, and the elastic adaptive segment is stretched. When the stent is installed in place, the second curved segment is rotated toward the distal end of the stent, and the elastic adaptive segment fits the autologous valve ring. Subsequently, the first curved segment is rotated toward the proximal end of the stent, so that the autologous valve ring is clamped between the first curved segment and the second curved segment.

[0037] According to one embodiment, after the artificial valve prosthesis is implanted, when the native valve ring contracts, the native valve ring abuts against and fits the elastic adaptive segment, and the elastic adaptive layer is stretched. When the native valve ring expands, the elastic adaptive segment contracts, and the native valve ring remains attached to the elastic adaptive segment.

[0038] According to one embodiment, a flexible skirt is provided between the fitting rods; and a buffer structure is provided at the free end portion of the fitting rod.

[0039] According to one embodiment, the buffer structure is located at the distal end of the fitting rod. The buffer structure can not only avoid piercing the atrial wall, but also better conform to the atrial wall to achieve a good fitting effect, avoid gaps and blood reflux.

[0040] According to one embodiment, the fitting rod comprises a first arc member and a second arc member, the first arc member conforms to the position of the valve ring, and the second arc member conforms to the shape of the atrium; and the bending direction of the first arc member is away from the center line of the stent, and the bending direction of the second arc member is toward the center line of the stent.

[0041] According to one embodiment, the atrial segment extends beyond the distalmost end of the first curved segment.

[0042] According to one embodiment, a cross-sectional area of ​​a projection surface of a first curved segment disposed on an anterior leaflet of the mitral valve is larger than a cross-sectional area of ​​a projection surface of a first curved segment disposed on an anterior leaflet of the mitral valve.

[0043] According to one embodiment, the atrial segment and the main body segment are integrally formed.

[0044] According to one embodiment, the first curved segment is connected to the atrial segment, and the strength of the atrial segment is greater than the strength of the first curved segment.

[0045] According to one embodiment, the stent further includes a fixing member and a limiting ring, wherein the fixing member is connected to the proximal end of the main body segment, and the limiting ring is connected to the fixing member.

[0046] According to one embodiment, when the stent is pre-installed, the fixing member is entirely located at the proximal end of the main body segment, and when the artificial valve prosthesis is released, the fixing member flips over to clamp the native leaflet between the main body segment and the fixing member, and the limiting ring embraces the native leaflet.

[0047] According to one embodiment, when the stent is pre-installed, the fixing member is entirely located at the proximal end of the main body segment, and when the artificial valve prosthesis is released, the fixing member flips over to clamp the native leaflet between the main body segment and the fixing member, and the limiting ring embraces the native leaflet.

[0048] According to an embodiment, the fulcrum is located at a distal portion of the body segment.

[0049] According to one embodiment, a film is attached to the surface of the bracket.

[0050] Compared with the prior art, the advantages of this application are:

[0051] 1. In the prior art, the valve prosthesis prevents paravalvular leakage by fitting the skirt to the atrial wall. However, the inner wall of the atrium is not regular and smooth. The atrium will squeeze the skirt during contraction and relaxation. At the same time, the squeezing force on the skirt at different positions is also different, which makes the skirt prone to wrinkles. Blood can enter the atrium through the gap between the valve ring and the valve prosthesis, and the gap between the atrial wall and the skirt, causing blood reflux and other problems. The present application solves the above problems. The sealing device includes a sealing frame and a leak-proof component connected to the sealing frame. The sealing frame includes a first curved segment and a second curved segment. The bracket is connected to the first curved segment and provides a fulcrum for the first curved segment. When the atrium is in diastole, the stent is connected to the first curved segment and provides a fulcrum for the first curved segment. The first curved section fits the atrial wall, the second leak-proof membrane fits the native valve ring, and the valve prosthesis is in close contact with the inner wall of the heart; when the atrium contracts, the sealing device is squeezed by the atrial wall, and the first curved section rotates around the fulcrum toward the center of the stent. This movement of the first curved section, on the one hand, drives the second curved section to rotate around the fulcrum toward the atrium, so that the second curved section fits the native valve ring. On the other hand, the leak-proof component includes a second leak-proof membrane. The first curved section can drive the second leak-proof membrane to lift the second curved section, so that the second curved section rotates toward the distal end to fit closely with the native valve ring, which helps to ensure the fitting function of the second leak-proof membrane and the second curved section, and effectively solves the problem of paravalvular leakage.

[0052] 2. Different from the prior art, the second leak-proof membrane connects the first curved section and the second curved section, and the second leak-proof membrane is flexible and has good ductility, so that the autologous valve ring can have a certain deformation space after being attached to the second leak-proof membrane, ensuring that the autologous valve ring can be tightly attached to the second leak-proof membrane in real time to prevent paravalvular leakage during heart movement.

[0053] 3. Different from the existing technology, since there is no leaflet barrier at the junction of the native leaflets, regurgitation is more likely to occur. The second curved section includes an arc portion and a convex portion. When the valve prosthesis is implanted, the convex portion is located at the junction of the native leaflets, adapting to the physiological shape inside the heart, thereby preventing blood reflux and comprehensively preventing the problem of paravalvular leakage.

[0054] 4. Different from the prior art, the first curved segment and the second curved segment are connected in one piece. When the first curved segment is squeezed, the first curved segment drives the second curved segment to rotate toward the distal end of the stent. It is worth mentioning that the stent includes a main body segment and an atrial segment, and the first curved segment is connected to the atrial segment. The advantages of this design are: on the one hand, whether the stent or the first curved segment is squeezed, the second curved segment can rotate accordingly to fit the native valve ring; on the other hand, when the atrium is diastolic, since the strength of the atrial segment is greater than that of the first curved segment, the atrial segment will drive the first curved segment to return to its original state to fit the atrial wall, and the compliance The rotation of the atrial segment is strengthened and the coordination with the heart is high; thirdly, the atrial segment is connected to the main segment, and the fulcrum on which the first curved segment and the atrial segment rotate is located at the distal part of the main segment. Due to the stable structure of the main segment, the rotation function of the second curved segment can be guaranteed no matter how many times the first curved segment is squeezed, which effectively prolongs the service life of the artificial valve prosthesis and has great clinical significance. In addition, during the diastole and contraction of the heart, the degree of squeezing of the first curved segment is different, and the position of the fulcrum located at the distal part of the main segment will also change accordingly. Therefore, the force points of the stent are not in one position, the stent is not easily damaged, and the fatigue life is high.

[0055] 5. Different from the prior art, the sealing device of the present invention further comprises an elastic thread, which is fixedly connected to the second leak-proof membrane, and the two form an elastic adaptation section. After the prosthesis is implanted, the elastic adaptation section is in close contact with the native valve ring, and the native valve ring is located between the first curved section and the second curved section, in an embedded state, and has a fixing effect. At the same time, the elastic adaptation section realizes compliance changes with the contraction or expansion of the native valve ring, so that the elastic adaptation layer can always stick to the native valve ring, thereby preventing blood from flowing back.

[0056] 6. Different from the prior art, the leakage-proof component also includes a third leakage-proof membrane which is connected to the second curved section at one end and is free at the other end. When the third leakage-proof membrane is impacted by blood flow from the direction of the ventricle, it will move along the direction of blood flow so that it can fit under the native valve ring. In addition, during the contraction and compression of the heart, the shape of the native valve ring is sometimes irregular. At this time, the second curved section cannot be completely fitted with the native valve ring, which makes blood reflux easy to occur. The third leakage-proof membrane is arranged on the periphery of the second curved section, which can effectively prevent the occurrence of blood reflux.

[0057] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below and are predictable and understandable to those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] The above-mentioned features and advantages and other features and advantages of these embodiments and the manner in which they are achieved will become more apparent, and the embodiments of the present application can be better understood by referring to the following description together with the accompanying drawings, in which:

[0059] Figures 1a to 1d FIG. 1 is a schematic diagram of the overall structure of the artificial valve prosthesis of the present invention, wherein Figure 1d It is a principle diagram of the second curved section rotating along with the first curved section, and the dotted line refers to the schematic diagram of the rotation of the first curved section and the second curved section after the sealing device is squeezed.

[0060] Figure 2a~2f It is a schematic diagram of the artificial valve prosthesis after implantation, a structural schematic diagram of the sealing device and a structural schematic diagram of the stent of the present invention.

[0061] Figure 3a to 3c It is a schematic diagram of the implantation process of the artificial valve prosthesis of the present invention.

[0062] Figures 4a to 4f The sealing device of the present invention is provided with an embodiment of an elastic wire.

[0063] Figure 5a and 5b This is another embodiment of the present invention.

[0064] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-stent, 11-main section, 12-atrial section, 121-fitting rod, 1211-first arc part, 1212-second arc part, 122-flexible skirt, 123-buffering structure, 13-fixing part, 14-limiting ring, 2-artificial valve leaflet, 3-sealing device, 31-first curved section, 32-second curved section, 321-arc part, 322-raised part, 33-leakage-proof component, 331-first leak-proof membrane, 332-second leak-proof membrane, 333-third leak-proof membrane, 34-elastic thread, 35-elastic adaptation section, 4-fulcrum. DETAILED DESCRIPTION

[0065] The present application is further described in detail below in conjunction with the accompanying drawings and embodiments. Specific embodiment:

[0067] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be described. From these descriptions, drawings and claims, other features, purposes and advantages of the present application can be clearly seen.

[0068] 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 accompanying drawings. The illustrated embodiments may be other embodiments and may be implemented or executed in various ways. Each example is provided by explaining the disclosed embodiments rather than limiting them. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence disclosed in the present application. For example, a feature illustrated or described as part of an embodiment may be used together with another embodiment to still produce another embodiment. Therefore, the present application discloses and covers such modifications and variations within the scope of the appended claims and their equivalent elements.

[0069] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents and additional items.

[0070] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0071] In the present application, “proximal end” refers to the end close to the apex of the heart, and “distal end” refers to the end away from the apex of the heart.

[0072] Embodiment 1

[0073] The mitral valve of the human heart has an anterior leaflet and a posterior leaflet. The anterior leaflet and the posterior leaflet are in a closed state when the heart contracts. When the anterior leaflet or the posterior leaflet cannot close normally in the closed state, valve regurgitation occurs.

[0074] like Figure 1a-1d As shown, according to an example, an artificial valve prosthesis with a sealing device 3 includes a stent 1, an artificial valve leaflet 2 and a sealing device 3, wherein the artificial valve leaflet 2 is arranged in the stent 1, and the sealing device 3 is at least partially arranged outside the stent 1, and the sealing device 3 includes a first curved segment 31, a second curved segment 32 and a leak-proof component 33, the first curved segment 31 is connected to the stent 1, and the stent 1 provides a fulcrum 4 for the first curved segment 31. After the stent 1 is installed in place, at least part of the first curved segment 31 is in contact with the atrial wall. When the atrial wall squeezes the sealing device 3, the first curved segment 31 rotates around the fulcrum 4 toward the center of the stent 1, and the first curved segment 31 drives the second curved segment 32, so that the second curved segment 32 rotates around the fulcrum 4 toward the atrium.

[0075] According to one example, the leakage-proof member 33 includes a first leakage-proof membrane 331, such as Figure 1b As shown, the first anti-leakage membrane 331 covers the surfaces of the first curved section 31 and the second curved section 32 .

[0076] According to one example, after the artificial valve prosthesis is implanted, the first curved section 31 is in close contact with the native valve ring and the atrial wall. Figure 2a As shown; and, when the atrial wall squeezes the sealing device 3, the second curved section 32 rotates toward the distal end of the stent 1 and adheres to the native valve ring, as shown Figure 2b As shown, it effectively prevents blood from flowing from the ventricle to the atrium, solving the problem of paravalvular leakage.

[0077] According to one example, the anti-leakage component 33 includes a second anti-leakage membrane 332, one end of which is connected to the first curved segment 31 or the second curved segment 32, and the other end is also connected to the first curved segment 31 or the second curved segment 32; and the second anti-leakage membrane 332 is flexible, and after the stent 1 is released, the second anti-leakage membrane 332 fits with the autologous valve ring.

[0078] According to one example, the distal end of the second anti-leakage membrane 332 is connected to the first curved section 31, the proximal end of the second anti-leakage membrane 332 is connected to the second curved section 32, and the second anti-leakage membrane 332 is not elastic. When the first curved section 31 rotates upward, the first curved section 31 can drive the second anti-leakage membrane 332 to lift the second curved section 32. Figure 2b shown.

[0079] According to an example, the flexible second anti-leakage membrane 332 can be made of polyester cloth with good extensibility.

[0080] According to one example, after the artificial valve prosthesis is implanted, the first curved segment 31 is in close contact with the native valve ring and the atrial wall; and when the atrial wall squeezes the sealing device 3, the second curved segment 32 rotates toward the distal end of the stent 1 and is in close contact with the native valve ring.

[0081] According to one example, the two ends of the second leak-proof membrane 332 are respectively connected to the first curved segment 31 and the second curved segment 32. After the artificial valve prosthesis is implanted, the native valve ring fits the second leak-proof membrane 332, and when the atrium contracts, the atrial wall squeezes the sealing device 3, and the free end of the first curved segment 31 drives the second leak-proof membrane 332 to pull the second curved segment 32 upward, so that the second curved segment 32 rotates toward the distal direction of the stent 1 and fits closely to the native valve ring.

[0082] According to an example, the first curved segment 31 and the second curved segment 32 are connected in one piece; and the first curved segment 31 and the second curved segment 32 are in a "tiger's mouth" shape at the connection, such as Figure 2c shown.

[0083] According to one example, the stent 1 includes a main body segment 11 and an atrial segment 12. Figure 2d As shown, the atrial segment 12 includes a plurality of fitting rods 121, and the fitting rods 121 are connected to the first curved segment 31; and, on the cross section where the central axis of the stent 1 is located, the shape of the fitting rods 121 is substantially the same as that of the first curved segment 31, and both are arc-shaped.

[0084] According to an example, the second curved section 32 includes an arc portion 321 and a convex portion 322. Figure 2f As shown, when the artificial valve prosthesis is implanted, the protrusion 322 is located at the junction of the native valve leaflets.

[0085] According to an example, the second curved section 32 includes two protrusions 322 , and the protrusions 322 are located at the junction of the anterior leaflet and the posterior leaflet of the mitral valve after the valve prosthesis is installed.

[0086] According to an example, a flexible skirt 122 is provided between the fitting rods 121; and a buffer structure 123 is provided at the free end of the fitting rod 121. Figure 1c and 2e shown.

[0087] According to one example, the buffer structure 123 is located at the distal end of the fitting rod 121. The buffer structure 123 can not only avoid piercing the atrial wall, but also better conform to the atrial wall to achieve a good fitting effect, avoid gaps, and prevent blood reflux.

[0088] According to an example, the fitting rod 121 includes a first arc part 1211 and a second arc part 1212. Figure 2e As shown, the first arc component 1211 conforms to the position of the valve ring, and the second arc component 1212 conforms to the shape of the atrium; and the bending direction of the first arc component 1211 is away from the center line of the stent 1, and the bending direction of the second arc component 1212 is toward the center line of the stent 1.

[0089] According to one example, the cross-sectional area of ​​the projection surface of the first curved segment 31 disposed on the anterior leaflet of the mitral valve is larger than the cross-sectional area of ​​the projection surface of the first curved segment 31 disposed on the anterior leaflet of the mitral valve.

[0090] According to one example, the atrial segment 12 and the main body segment 11 are integrally formed.

[0091] According to one example, the atrial segment 12 extends beyond the distal end of the first curved segment 31. Figure 1a shown.

[0092] According to one example, the fulcrum 4 is located at the distal end of the main body segment 11, such as Figure 1c shown.

[0093] According to an example, the first curved segment 31 is connected to the atrial segment 12 , and the strength of the atrial segment 12 is greater than the strength of the first curved segment 31 .

[0094] According to one example, the stent 1 further includes a fixing member 13 and a limiting ring 14, wherein the fixing member 13 is connected to the proximal end of the main body segment 11, and the limiting ring 14 is connected to the fixing member 13. Figure 3a shown.

[0095] According to one example, when the stent 1 is pre-installed, the fixing member 13 is located as a whole at the proximal end of the main body section 11. When the artificial valve prosthesis is released, the fixing member 13 is turned over to clamp the autologous valve leaflet between the main body section 11 and the fixing member 13, and the limiting ring 14 embraces the autologous valve leaflet. Figure 3b and 3c shown.

[0096] Embodiment 2

[0097] The second embodiment is substantially the same as the first embodiment except that, in the second embodiment, the sealing device 3 further comprises an elastic thread 34 , and the elastic thread 34 is combined with the second anti-leakage membrane 332 to form an elastic adaptation section 35 .

[0098] like Figure 4a and 1b As shown, an artificial valve prosthesis with a sealing device 3 includes a stent 1, an artificial valve leaflet 2 and a sealing device 3, wherein the artificial valve leaflet 2 is arranged in the stent 1, and the sealing device 3 is at least partially arranged outside the stent 1, and the sealing device 3 includes a first curved segment 31, a second curved segment 32 and a leak-proof component 33, the first curved segment 31 is connected to the stent 1, and the stent 1 provides a fulcrum 4 for the first curved segment 31, after the stent 1 is installed in place, at least part of the first curved segment 31 is in contact with the atrial wall, when the atrial wall squeezes the sealing device 3, the first curved segment 31 rotates around the fulcrum 4 toward the center of the stent 1, and the first curved segment 31 drives the second curved segment 32, so that the second curved segment 32 rotates around the fulcrum 4 toward the atrium.

[0099] According to one example, the sealing device 3 further comprises an elastic thread 34, the elastic thread 34 is fixedly connected to the second leak-proof membrane 332, the second leak-proof membrane 332 and the elastic thread 34 are combined to form an elastic adaptation section 35, the elastic adaptation section 35 produces compliant deformation as the native valve ring expands and contracts, and the elastic adaptation section 35 is always close to the native valve ring, such as Figure 4a and 4b shown.

[0100] According to one example, during pre-installation, the first curved section 31 is attached to the distal end of the stent 1. Figure 4c-4e As shown, the second curved segment 32 is attached to the proximal end of the stent 1, and the elastic adaptive segment 35 is stretched. When the stent 1 is installed in place, the second curved segment 32 is rotated toward the distal end of the stent 1, and the elastic adaptive segment 35 is attached to the autologous valve ring. Subsequently, the first curved segment 31 is rotated toward the proximal end of the stent 1, so that the autologous valve ring is clamped between the first curved segment 31 and the second curved segment 32.

[0101] According to one example, during pre-installation, the elastic thread 34 is straightened, and the length of the elastic thread 34 is equal to the axial length of the second anti-leakage membrane 332. After release, the elastic thread 34 fits the shape of the native valve ring as a whole, such as Figure 4f shown.

[0102] According to one example, when the atrial wall squeezes the sealing device 3 , the first curved segment 31 rotates toward the center line of the stent 1 , and at the same time, the first curved segment 31 drives the second curved segment 32 to rotate toward the distal end of the stent 1 .

[0103] According to one example, the first curved segment 31 is connected to the atrial segment 12 , and the second curved segment 32 is connected to the outer surface of the main body segment 11 .

[0104] According to one example, after the artificial valve prosthesis is implanted, when the autologous valve ring contracts, the autologous valve ring abuts against and fits the elastic adaptation segment 35, the elastic adaptation layer is stretched, and when the autologous valve ring expands, the elastic adaptation segment 35 contracts, and the autologous valve ring is still attached to the elastic adaptation segment 35, such as Figure 4b shown.

[0105] The remaining structures and concepts of the second embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0106] Embodiment 3

[0107] The third embodiment is substantially the same as the first embodiment except that, in the third embodiment, the sealing device 3 further includes a third anti-leakage membrane 333 .

[0108] like Figure 5a and 1b As shown, an artificial valve prosthesis with a sealing device 3 includes a stent 1, an artificial valve leaflet 2 and a sealing device 3, wherein the artificial valve leaflet 2 is arranged in the stent 1, and the sealing device 3 is at least partially arranged outside the stent 1, and the sealing device 3 includes a first curved segment 31, a second curved segment 32 and a leak-proof component 33, wherein the first curved segment 31 is connected to the stent 1, and the stent 1 provides a fulcrum 4 for the first curved segment 31, and after the stent 1 is installed in place, at least part of the first curved segment 31 is in contact with the atrial wall, and when the atrial wall squeezes the sealing device 3, the first curved segment 31 rotates around the fulcrum 4 toward the center of the stent 1, and the first curved segment 31 drives the second curved segment 32, so that the second curved segment 32 rotates around the fulcrum 4 toward the atrium.

[0109] According to one example, the anti-leakage component 33 includes a third anti-leakage membrane 333, one end of the third anti-leakage membrane 333 is connected to the second curved section 32, and the other end is free. Figure 5a shown.

[0110] According to one example, after the artificial valve prosthesis is implanted, when the left ventricle is squeezed, the blood flow impacts the third leak-proof membrane 333, so that the third leak-proof membrane 333 is closely attached to the lower side of the mitral valve ring.

[0111] According to an example, the third anti-leakage membrane 333 is connected to the outer periphery of the second curved section 32 .

[0112] According to an example, during the process of cardiac contraction and compression, the shape of the native valve ring is sometimes irregular, so that the second leak-proof membrane 332 cannot completely fit the native valve ring, so that blood reflux is likely to occur. The third leak-proof membrane 333 is arranged on the periphery of the second curved section 32, which can effectively prevent the occurrence of blood reflux. Figure 5b shown.

[0113] The remaining structure and concept of the third embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0114] The above contents are only preferred embodiments of the present application. For ordinary technicians in this field, according to the concept of the present application, there may be changes in the specific implementation methods and application scopes. The contents of this specification should not be understood as limiting the present application.

Claims

1. An artificial valve prosthesis with a sealing device, comprising a stent, an artificial valve leaflet and a sealing device, wherein the artificial valve leaflet is arranged in the stent, and the sealing device is at least partially arranged outside the stent, characterized in that: The sealing device includes a sealing frame and a leak-proof component connected to the sealing frame, the sealing frame is connected to the bracket, and the bracket provides a fulcrum for the sealing frame, the sealing frame includes a first curved section and a second curved section, after the bracket is installed in place, at least part of the first curved section is in contact with the heart tissue wall, when the heart tissue squeezes the sealing device, the first curved section rotates around the fulcrum toward the center of the bracket, and the first curved section drives the second curved section to rotate in the same direction; the first curved section and the second curved section are connected in one piece; and the first curved section and the second curved section are in a "tiger's mouth" shape at the connection, the second curved section includes an arc portion and a convex portion, and when the artificial valve prosthesis is implanted, the convex portion is located at the junction of the autologous leaflets.

2. The artificial valve prosthesis with a sealing device according to claim 1, characterized in that: The anti-leakage component includes a first anti-leakage film, and the first anti-leakage film covers the surfaces of the first curved section and the second curved section.

3. The artificial valve prosthesis with a sealing device according to claim 1, characterized in that: The anti-leakage component includes a second anti-leakage membrane, one end of which is connected to the first curved segment or the second curved segment, and the other end is also connected to the first curved segment or the second curved segment; and the second anti-leakage membrane is flexible, and after the stent is released, the second anti-leakage membrane fits with the autologous valve ring.

4. The artificial valve prosthesis with a sealing device according to claim 1, characterized in that: The anti-leakage component comprises a third anti-leakage membrane, one end of the third anti-leakage membrane is connected to the second curved section, and the other end is free.

5. The artificial valve prosthesis with a sealing device according to claim 2, characterized in that: When the artificial valve prosthesis is implanted, the first curved section is in close contact with the native valve ring and the atrial wall; and when the atrial wall squeezes the sealing device, the second curved section rotates toward the distal end of the stent and is in close contact with the native valve ring.

6. The artificial valve prosthesis with a sealing device according to claim 3, characterized in that: The two ends of the second leak-proof membrane are respectively connected to the first curved segment and the second curved segment. After the artificial valve prosthesis is implanted, the native valve ring fits the second leak-proof membrane, and when the atrium contracts, the atrial wall squeezes the sealing device, and the free end of the first curved segment drives the second leak-proof membrane to pull the second curved segment upward, so that the second curved segment rotates toward the distal end of the stent and fits closely to the native valve ring.

7. The artificial valve prosthesis with a sealing device according to claim 1, characterized in that: The stent includes a main body section and an atrial section, the atrial section includes a plurality of fitting rods, and the fitting rods are connected to the first curved section; and on the cross section where the central axis of the stent is located, the shape of the fitting rods is substantially the same as that of the first curved section, and both are arc-shaped.

8. The artificial valve prosthesis with a sealing device according to claim 3, characterized in that: The sealing device also includes an elastic thread, which is fixedly connected to the second leak-proof membrane. The second leak-proof membrane and the elastic thread are combined to form an elastic adaptive section. The elastic adaptive section produces compliant deformation as the autologous valve ring expands and contracts, and the elastic adaptive section always sticks to the autologous valve ring.

9. The artificial valve prosthesis with a sealing device according to claim 8, characterized in that: During pre-installation, the first curved segment is attached to the distal end of the stent, the second curved segment is attached to the proximal end of the stent, and the elastic adaptive segment is stretched. When the stent is installed in place, the second curved segment is rotated toward the distal end of the stent, and the elastic adaptive segment fits the autologous valve ring. Subsequently, the first curved segment is rotated toward the proximal end of the stent, so that the autologous valve ring is clamped between the first curved segment and the second curved segment.

10. The artificial valve prosthesis with a sealing device according to claim 7, characterized in that: A flexible skirt is provided between the fitting rods; and a buffer structure is provided at the free end portion of the fitting rod.

11. The artificial valve prosthesis with a sealing device according to claim 7, characterized in that: The first curved segment is connected to the atrial segment, and the strength of the atrial segment is greater than the strength of the first curved segment.

12. The artificial valve prosthesis with a sealing device according to claim 7, characterized in that: The stent further comprises a fixing member and a limiting ring, wherein the fixing member is connected to the proximal end of the main body segment, and the limiting ring is connected to the fixing member.

13. The artificial valve prosthesis with a sealing device according to claim 12, characterized in that: When the stent is pre-installed, the fixing part is entirely located at the proximal end of the main body segment. When the artificial valve prosthesis is released, the fixing part flips over to clamp the autologous valve leaflet between the main body segment and the fixing part, and the limiting ring embraces the autologous valve leaflet.

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