A heart valve stent and its prosthesis
By combining the catch structure of the heart valve stent with the inflow tract flange, the problems of poor fatigue resistance and high delivery difficulty of the mitral valve prosthesis are solved, realizing low-risk delivery and low-interference valve replacement, and reducing the risk of paravalvular leakage and left ventricular outflow tract obstruction.
Patent Information
- Application Number
- CN201910223986.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2019-03-22
- Publication Date
- 2025-11-21
- Estimated Expiration
- 2039-03-22
AI Technical Summary
In the existing technology, the leaflet area of the mitral valve prosthesis is large, resulting in poor fatigue resistance, high delivery difficulty, high risk of vascular damage, and risks of subvalvular interference and left ventricular outflow tract obstruction.
The stent design utilizes a heart valve structure that clamps the original leaflet to the inflow tract mesh using an apron structure. Combined with the inflow tract flange and apron structure, it achieves anchoring, reduces the outer diameter of the leaflet, decreases the diameter of the delivery system catheter, and reduces the risk of vascular injury. Furthermore, the apron apron fixes the free leaflet, reducing left ventricular outflow tract obstruction caused by anterior leaflet movement during systole.
It improves the fatigue resistance of valve prostheses, reduces delivery difficulty and the risk of vascular injury, reduces subvalvular tissue interference and left ventricular outflow tract obstruction, and reduces the possibility of paravalvular leakage.
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Figure CN111714250B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to an interventional medical device, in particular to a heart valve stent and a prosthesis thereof. BACKGROUND
[0002] The heart contains four chambers, the left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart. The atrium and ventricle form the ventricular inflow tract, the left ventricle and the aorta form the left ventricular outflow tract, and the right ventricle and the pulmonary artery form the right ventricular outflow tract. There are valves with "one-way valve" function at the inflow tract and outflow tract, which ensure the normal flow of blood in the heart chamber. When the valve is problematic, the cardiac hemodynamics changes and the heart function is abnormal, which is called valvular heart disease.
[0003] With the development of social economy and the aging of the population, the incidence of valvular heart disease has increased significantly, and research shows that the incidence of valvular heart disease in people over 75 years old is as high as 13.3%. Surgical treatment is still the preferred treatment for patients with severe valvular disease, but for elderly patients with multiple organ diseases, a history of thoracotomy, and poor cardiac function, the risk of surgery is high, and the surgical mortality rate is high, and even some patients lose the opportunity for surgery. Transcatheter valve implantation / repair surgery has the advantages of no need for thoracotomy, small trauma, and rapid recovery of patients, and has received widespread attention from experts and scholars.
[0004] The mitral valve, also known as the mitral valve, is located in the left ventricular inflow tract, and its main structure is the mitral valve complex, including the mitral valve annulus, the valve leaflet, the chordae tendineae, and the papillary muscle, and some literature also includes the ventricular wall. The mitral valve annulus is a dense connective tissue around the atrioventricular orifice of the left atrium, and the anterior annulus is composed of part of the non-coronary annulus of the aortic valve, part of the left coronary annulus, and the left and right fibrous triangles, and the posterior annulus is the posterior leaflet attachment. The anterior leaflet of the mitral valve is a fibrous extension of the aortic valve, which forms the left ventricular inflow tract with the posterior leaflet, and forms the left ventricular outflow tract with the interventricular septum. The chordae tendineae of the mitral valve serve as a support device connecting the mitral valve leaflet to the myocardium, and are distributed between the leaflet and the myocardium. The subvalvular structure of the mitral valve plays an important role in maintaining the left heart structure and function.
[0005] The tricuspid valve, as the atrioventricular valve of the right heart, has a similar structure to the mitral valve, also containing valve leaflets, annulus, chordae tendineae, papillary muscles, and myocardium. Therefore, the structure of the heart valve prosthesis for replacing the native mitral valve can also be applied to replace the native tricuspid valve, and the size of the prosthetic valve is different according to the size of the native valve.
[0006] Although the field of mitral valve replacement has developed rapidly, there are some recognized difficulties in the design of valve prostheses:
[0007] 1. Compared with the aortic valve, the native annulus diameter of the mitral valve is larger, and accordingly, the leaflet area of the artificial valve is also very large. The larger the leaflet area, the worse the fatigue resistance of the valve prosthesis. At the same time, the larger the leaflet area, the larger the size of the stent required, and the larger the diameter of the catheter used to deliver the valve prosthesis, increasing the difficulty of delivery and the risk of vascular injury.
[0008] 2. The atrioventricular valve assembly has a complex structure, and if the subvalvular height of the prosthesis valve is too high, it will affect the native heart structure and heart function, cause chordae tendineae rupture, touch the papillary muscle and other abnormal heart tissues, and easily cause left ventricular outflow tract obstruction, inducing adverse postoperative effects.
[0009] 3. Due to the presence of unsecured free leaflets, systolic anterior motion (SAM) may occur, causing left ventricular outflow tract obstruction. SAM refers to the movement of unsecured native leaflets during ventricular systole due to heartbeats.
[0010] 4. The stent is difficult to anchor and has a risk of displacement. SUMMARY
[0011] The technical problem to be solved by the present application is to provide a heart valve stent and a prosthesis thereof, wherein the leaflet diameter of the valve prosthesis is small, the fatigue resistance of the valve is good, and the difficulty of delivery and the risk of vascular injury are reduced.
[0012] The technical solution adopted by the present application to solve the above technical problem is to provide a heart valve stent, which comprises a stent body, the stent body has an inflow and an outflow connected in an axial direction, the inflow and the outflow are both composed of interconnected mesh structure units, the stent body is provided with a grab ear structure extending towards the proximal end of the inflow, the proximal end of the inflow is outwardly folded, and a gap is formed between the proximal end of the grab ear structure and the inflow.
[0013] Preferably, the outer diameter of the distal end of the outflow is smaller than the outer diameter of the distal end of the inflow.
[0014] Preferably, the grab ear structure comprises front side grab ears and rear side grab ears, the front side grab ears and the rear side grab ears are unevenly distributed in the circumferential direction of the stent body, the central angle of the front side grab ears distributed in the circumferential direction ranges from 10° to 120°, and the central angle of the rear side grab ears distributed in the circumferential direction ranges from 30° to 330°.
[0015] Preferably, the grab ear structure further comprises front leaf grab ears, the central angle of the front leaf grab ears distributed in the circumferential direction ranges from 330° to 30°, and barbs or sawteeth are arranged on the side of the front leaf grab ears facing the stent body.
[0016] Preferably, the ear structure is a cantilever structure with a fixed end and a free end, the fixed end of the ear structure is located on the outflow tract, and a gap is formed between the free end and the inflow tract.
[0017] Preferably, the ear structure is a rod structure, the fixed end is located at the end of the outflow tract, and the free end is spherical or ellipsoidal.
[0018] Preferably, the free end of the front ear is outwardly folded, and the free end of the rear ear is inwardly folded.
[0019] Preferably, the ear structure is integrally formed with the stent body, or the ear structure and the stent body are connected by riveting, welding or buckling.
[0020] Preferably, the two ends of the ear structure are fixed on the stent body, and the ear structure and the grid structure unit of the stent body form a closed structure.
[0021] Preferably, the proximal end port of the inflow tract has an outer diameter of 35-75mm, the rigidity of the inflow tract is greater than that of the outflow tract, the height of the outflow tract in the axial direction is 5-20mm, and the outer diameter is 21-55mm.
[0022] Another technical solution adopted by the present application to solve the above technical problems is to provide a heart valve prosthesis, comprising a heart valve stent and a valve, the valve is fixedly arranged on the inner surface of the stent body, and the heart valve stent is the above-mentioned heart valve stent.
[0023] The heart valve stent and its prosthesis provided by the present application have the following beneficial effects compared with the prior art: the ear structure and the inflow tract grid of the present application clamp the original valve leaflet, replacing the oversize anchoring mode of the existing stent body, so that the outflow tract body, i.e. the valve leaflet suture area, has a smaller outer diameter. The fatigue resistance of the valve leaflet with a smaller outer diameter will be improved, and the diameter of the catheter of the delivery system suitable for the present application can also be set smaller, reducing the difficulty of delivery and the risk of blood vessel injury. The subvalvular height of the heart valve stent required by the valve leaflet with a smaller outer diameter is smaller, the interference of the stent to the subvalvular tissue of the heart (such as papillary muscle, ventricular wall, etc.) is solved, and the heart function and the fatigue resistance of the stent are improved. The reduction of the axial height of the stent also reduces the left ventricular outflow tract obstruction (LVOTO). In particular, the anterior leaflet ear can fix the free valve leaflet and reduce the possibility of blocking the left ventricular outflow tract caused by systolic anterior motion (SAM). In addition, the flange shape of the inflow tract fits the clamping of the ear structure, reducing the risk of paravalvular leakage. BRIEF DESCRIPTION OF DRAWINGS
[0024] Figure 1 Fig. 2 is a structure schematic view of the front direction of a heart valve prosthesis according to an embodiment of the present application;
[0025] Figure 2 Fig. 3 is a structure schematic view of the top direction of a heart valve prosthesis according to an embodiment of the present application;
[0026] Figure 3 Fig. 4 is a structure schematic view of a heart valve stent according to an embodiment of the present application;
[0027] Fig. 4(a) is a schematic view of the circumferential distribution of the ear structure of the heart valve stent according to an embodiment of the present application, and Fig. 4(b) is a schematic view of the angular distribution of the ear structure in the circumferential direction;
[0028] Figure 5 Fig. 5 is a schematic view of the cross section of a native valve;
[0029] Figure 6 Fig. 6 is a schematic view of the use state of a heart valve prosthesis implanted in a human body according to an embodiment of the present application;
[0030] Figure 7 Fig. 7 is a schematic view of the use state of a heart valve prosthesis implanted in a human body according to an embodiment of the present application; Figure 6 Fig. 8 is a schematic view of the use state of a heart valve prosthesis implanted in a human body according to an embodiment of the present application;
[0031] Fig. 9 is a schematic view of the use state of a heart valve prosthesis implanted in a human body according to an embodiment of the present application;
[0032] 1 heart valve prosthesis 2 heart 21 myocardial wall
[0033] 10 stent main body 20 skirt 30 valve 101 inflow
[0034] 102 outflow 103 front ear 104 rear ear 105 anterior leaflet ear
[0035] 101A proximal end of inflow 101B distal end of inflow 102A proximal end of outflow 102B distal end of outflow
[0036] 106 ear 103A fixed end 103B free end 1011 inflow flange
[0037] P posterior leaflet A anterior leaflet L lateral side M medial side
[0038] CL anterior-lateral commissure CM posterior-medial commissure DETAILED DESCRIPTION
[0039] The present application will be further described below in conjunction with the drawings and embodiments.
[0040] The heart valve prosthesis provided by the embodiment is a transcatheter implantable artificial heart valve prosthesis, mainly used for replacing a heart valve. The heart valve prosthesis has the characteristics of small size and good fatigue resistance. The structure of the valve prosthesis can be designed to match the original heart structure, so that the original heart valve can be completely replaced, and the damage to the subvalvular structure is small, and the risk of outflow tract obstruction is low.
[0041] In order to more clearly describe the structural features of the present application, "proximal", "distal", "outward", "inward" are used as directional words, wherein "proximal" means the end close to the operator during the operation; "distal" means the end away from the operator; "outward" means the direction away from the center axis of the stent body; "inward" means the direction close to the center axis of the stent body. The term "or" is generally used in the sense of including "and / or", unless the context clearly indicates otherwise.
[0042] Please refer to Figure 1 、 Figure 2 and Figure 3 , the heart valve stent and its prosthesis have two forms of compression state and expansion state. In the present application, the features of the heart valve stent or its prosthesis in the expanded state are described unless otherwise emphasized. The heart valve prosthesis 1 comprises a heart valve stent, a skirt 20 and a valve 30. The heart valve stent comprises a stent body 10, the stent body 10 has an inflow tract 101 and an outflow tract 102 connected in the axial direction. According to the direction of blood flow, the outflow tract 102 is located downstream of the inflow tract 101. The inflow tract 101 corresponds to the part of the blood flowing into the heart valve prosthesis during valve operation, and the outflow tract 102 corresponds to the part of the blood flowing out of the heart valve prosthesis during valve operation. The stent body 10 is composed of grid-shaped structure units or wave-shaped structure units, which can change in axial form. Axially, it is composed of at least one row of circumferentially connected structure units. Axially, the units can be directly or indirectly connected to each other. Preferably, the grid-shaped structure unit is a structure unit that can form a closed shape, such as a triangle, a rhombus, a pentagon, a hexagon, a water droplet, etc.
[0043] The stent body 10 is provided with a grab ear structure for anchoring and a hanging ear 106 for matching with the delivery system. The grab ear structure is divided into front side grab ear 103, rear side grab ear 104 and front leaf grab ear 105 according to structure and function. The grab ear structure is arranged on the stent body 10 and extends outwardly towards the inflow tract proximal end 101A, preferably from the end of the outflow tract 102 towards the inflow tract proximal end 101A. The hanging ear 106 is located on the end of the inflow tract 101 and / or the end of the outflow tract 102, except for the end of the outflow tract occupied by the grab ear structure.
[0044] The inflow 101 is outwardly turned in shape, i.e. the port of the inflow 101 is turned outwardly, and its maximum outer diameter is greater than the diameter of the annulus of the native valve, preferably 35-75 mm, and its stiffness is higher than that of the outflow 102. The height of the inflow 101 in the axial direction is not particularly limited as long as the anatomy is met, and is preferably 2-12 mm. The purpose of such arrangement is that at least a part of the inflow 101 can be located above the annulus of the native valve to form an inflow flange 1011, which is fitted to the annulus and the atrial wall anatomy, on one hand, the inflow flange 1011 can prevent paravalvular leakage after the skirt 20 is sutured thereon, on the other hand, a gap is formed between the inflow flange 1011 and the proximal end of the ear structure, which can hold the myocardial wall or the native valve leaflet to achieve anchoring. The main body of the inflow 101 can be circular, D-shaped or elliptical, and is preferably D-shaped or elliptical to match the shape of the annulus of the mitral valve. The skirt 20 is sutured on the stent inflow 101 to prevent paravalvular leakage.
[0045] The stent outflow 102 is located on the outflow side of the hemodynamics of the native valve. The outer diameter of the distal end 102B of the outflow is smaller than that of the distal end 101B of the inflow. The height of the stent outflow 102 in the axial direction is preferably 5-20 mm, and its outer diameter is preferably 21-55 mm. The body of the outflow 102 is composed of closed grid structure units, which provide attachment points for the valve leaflets but do not provide support force for the stent. Therefore, compared with the existing outflow structure which provides support force for the stent, the outer diameter of the outflow 102 of the present embodiment is smaller, the smaller outer diameter of the outflow reduces the diameter of the valve leaflet, correspondingly improves the fatigue resistance of the valve leaflet, and at the same time reduces the risk of axial height of the outflow 102, subvalvular interference and left ventricular outflow obstruction (LVOTO).
[0046] Please refer to FIG. 4(a), the ear structure is divided into front ear 103, anterior leaflet ear 105 and rear ear 104 according to structure and function, and the anterior leaflet ear 105 is selected as needed. The ear structure is unevenly distributed in the circumferential direction. As for the angle of distribution, the present application does not have special limitations, and should be adapted according to the human anatomy, and FIG. 4(a) only shows one of the embodiments. FIG. 4(b) is a schematic diagram of the angle distribution of the ear structure in the circumferential direction. Please refer to FIG. 4(b), taking the radius as the starting edge of the center angle, in general, the front ear 103 is distributed in the circumferential direction at a center angle of 10°-120°, preferably 30°-50°. The rear ear 104 is distributed in the circumferential direction at a center angle of 30°-330°, preferably 100°-260°. The anterior leaflet ear 105 is distributed in the circumferential direction at a center angle of 330°-30°, preferably 350°-10°. The number of the three is not particularly limited.
[0047] Please continue to refer to Figure 3As shown in Figure 4, the anterior awl 103 extends from the stent body 10, preferably from the center of the unit grid on the outflow duct 102 or from the end of the outflow duct 102 towards the proximal end 101A of the inflow duct. The anterior awl 103 has a fixed end 103A and a free end 103B, with the free end 103B located away from the stent body 10 and the fixed end 103A, facing towards the inflow duct 101. The axial height of the anterior awl 103 is adjusted according to the axial height of the outflow duct 102 to match the shape of the inflow duct 101. Specific values are not specifically defined in this invention, but are generally 0-10 mm, fitting snugly against the ventricular wall structures on both sides of the left ventricular outflow duct. The preferred clamping position of the anterior awl 103 is... Figure 5 The anterior lateral commissure (CL) region and the posteromedial commissure (CM) region are shown in the diagram.
[0048] Please continue reading Figure 5 The anchoring point of the rear grab ear 104 is Figure 5 In the P region of the posterior leaflet of the mitral valve, namely the areas P1, P2L, P2M, and P3, the anchoring is achieved by the posterior gripper 104 and the inflow flange 1011 working together to form a clamping force. Please refer to [link to relevant documentation]. Figure 6 and 7 The posterior awl 104, after adhering to the ventricular wall, forms a clamping force between itself and the inflow flange 1011, thereby clamping the corresponding myocardial shelf structure. The clamping anchoring force provided by the combined anterior awl 103 and posterior awl 104 reduces the radial support force required for the heart valve prosthesis at the native valve annulus, lowering the risk of tearing the native valve annulus. Simultaneously, it allows the valve prosthesis to have a smaller diameter, improving its fatigue resistance.
[0049] The anterior leaflet grasper 105 is mainly used to limit the movement of the primary leaflet; it can be set or not, depending on the needs. Please refer to... Figure 5 The anterior leaflet awl 105 is located in the A2 region (i.e., A2L and A2M) of the anterior leaflet of the mitral valve. The anterior leaflet awl 105 has a limiting function on the native leaflet, clamping the native leaflet between the anterior leaflet awl 105 and the inflow flange 1011. On the one hand, this reduces the risk of left ventricular outflow tract obstruction (LVOTO) caused by systolic anterior leaflet movement (SAM), and on the other hand, it enhances the seal between the prosthetic valve and the native valve annulus, reducing the possibility of paravalvular leakage. Preferably, the side of the anterior leaflet awl 105 that is in contact with the native leaflet (i.e., the part that needs to be clamped with the inflow flange 1011) has a certain degree of roughness, such as being provided with barbs or being serrated, to increase the friction between the cantilever structure of the anterior leaflet awl 105 and the leaflet, and improve the anchoring stability.
[0050] The ear structure and the stent body 10 can be integrally machined, or connected by riveting, welding, buckling or any other stable connection method.
[0051] Preferably, the ear structure is a cantilever structure, and the gap between the free end of the cantilever and the inflow flange 1011 is selected according to the anatomical size of the annulus and the myocardial wall to provide the required pre-tightening force for clamping the myocardial wall, and the cantilever has strong rigidity to ensure that it does not deform and fall off when clamping the myocardial wall. Here, "strong rigidity" means that the cantilever does not deform and fall off, without specific numerical limits. As an option, the cantilever structure is a rod structure, and the fixed point of each cantilever structure to the stent body 10 is one position, which is located on the mesh of the outflow tract 102 or the end of the outflow tract 102, and the free end is a spherical, ellipsoidal or other shape without obvious corners. Preferably, the free end of the front ear 103 is outward, as shown in Figure 3 and 5 , to facilitate cooperation with the inflow flange 1011 to clamp the myocardial wall in the CL region and the CM region. The free end of the rear ear 104 is inward, as shown in Figure 3 and 5 , to prevent damage to the myocardial tissue by clamping the valve prosthesis on the myocardial wall in the P2 region. The free end of the anterior leaflet ear 105 is outward, as shown in Figure 3 and 5 , to facilitate cooperation with the inflow flange 1011 to clamp the valve leaflet in the A2 region.
[0052] In another embodiment, the ear structure and the mesh unit of the stent body 10 form a closed structure, which is different from the cantilever structure, and both ends of the ear structure are fixed on the stent body 10 without a free end. The proximal end of the closed structure cooperates with the inflow flange 1011 to provide clamping force to the myocardial wall. In addition, the distal end of the closed structure can also provide a certain support force to the valve stent to reduce the size of the stent outflow tract 102.
[0053] The ear 106 is used to match the delivery system of the heart valve prosthesis, to achieve the loading and release of the valve prosthesis. The ear 106 is the structure for the valve prosthesis to finally separate from the delivery system, so the ear 106 is located on the end of the inflow tract 101 or / and the outflow tract 102, except for the outflow tract end occupied by the ear structure (front ear 103, rear ear 104, anterior leaflet ear 105). Specifically, according to the implantation method of the valve prosthesis and the function of the delivery system, the ear 106 can be distributed at the end of the inflow tract 101, corresponding to the release process of the outflow tract 102 first; the ear 106 can also be distributed at the end of the outflow tract 102, corresponding to the release process of the inflow tract 101 first; the ear 106 can also be distributed at the end of the outflow tract and the end of the inflow tract, corresponding to the release process of bidirectional release, which can choose to release the ear on one side first or choose to release the ears on both sides at the same time.
[0054] The stent body 10 is covered with a skirt 20 made of pericardium or other biocompatible polymer material, which cooperates with the valve 30 to form a single blood flow channel. Preferably, the valve 30 is arranged on the inner surface of the stent body 10, and the skirt 20 is sewn on the inner surface or the outer surface of the inflow flange 1011.
[0055] The stent body 10 is made of a metal material with memory characteristics (i.e. with self-expanding performance) and biocompatibility, preferably a nickel-titanium alloy pipe is cut to manufacture. The outer diameter of the metal pipe is preferably 5-15 mm, and the diameter size after shaping can be selected according to the actual needs of the heart valve stent.
[0056] In summary, unlike the anchoring method of oversize fit of the existing stent body, the heart valve prosthesis provided in the embodiment is anchored by clamping the native leaflet through the cooperation between the ear structure and the inflow tract grid. This anchoring method makes the outflow tract body, i.e. the leaflet suture area, have a smaller outer diameter, and the anti-fatigue performance of the smaller diameter leaflet will be improved, at the same time, the diameter of the catheter of the delivery system adapted to the invention can also be set smaller, reducing the difficulty of delivery and the risk of vascular injury. The smaller diameter of the leaflet requires a smaller subvalvular height of the stent, which solves the interference of the stent with the subvalvular tissue of the heart (such as papillary muscle, ventricular wall, etc.), and improves the heart function and the anti-fatigue performance of the stent. The reduction of the axial height of the stent reduces the obstruction of the left ventricular outflow tract (LVOTO). In particular, the anterior leaflet ear 105 can fix the free leaflet, reducing the possibility of blocking the left ventricular outflow tract caused by the systolic anterior leaflet movement (SAM). In addition, the conforming shape of the inflow flange 1011 assists the clamping of the ear structure, reducing the risk of paravalvular leakage.
[0057] Although the present application has been disclosed in its preferred embodiments with reference to the drawings, it will be apparent to those skilled in the art that modifications and improvements can be made without departing from the spirit and scope of the application, and it is intended to cover in the claims any such modifications and improvements that fall within the scope of the application.
Claims
1. A heart valve stent, characterized by, The heart valve stent comprises a stent body having an inflow passage and an outflow passage connected axially, the inflow passage and the outflow passage are both composed of interconnected mesh structure units, the stent body is provided with a grab ear structure extending towards the proximal end of the inflow passage, the proximal end of the inflow passage is folded outward, at least a part of the inflow passage is located above the annulus of the native valve to form an inflow passage flange, a gap is formed between the proximal end of the grab ear structure and the inflow passage flange to clamp the myocardial wall to achieve anchoring; the grab ear structure comprises a front side grab ear, a rear side grab ear and a front leaf grab ear, the front side grab ear and the rear side grab ear are unevenly distributed in the circumferential direction along the stent body, the central angle of the front side grab ear distributed in the circumferential direction ranges from 10° to 120°, the central angle of the rear side grab ear distributed in the circumferential direction ranges from 30° to 330°, and the central angle of the front leaf grab ear distributed in the circumferential direction ranges from 330° to 30°, the grab ear structure is a cantilever structure having a fixed end and a free end, the fixed end of the grab ear structure is located on the outflow passage, and a gap is formed between the free end and the inflow passage flange; the front side grab ear is used to adhere to and clamp the ventricular wall structure on both sides of the left ventricular outflow tract; the rear side grab ear is used to adhere to the ventricular wall behind and form a clamping force between the inflow passage flange to clamp the corresponding annulus structure; the front leaf grab ear is used to clamp the native valve leaflet between the front leaf grab ear and the inflow passage flange.
2. The heart valve support of claim 1, wherein, The outer diameter of the distal end of the outflow passage is smaller than the outer diameter of the distal end of the inflow passage.
3. The heart valve support of claim 1, wherein, The front leaf grab ear is provided with barbs or sawteeth on the side facing the stent body.
4. The heart valve support of claim 1, wherein, The grab ear structure is a rod-shaped structure, the fixed end is located at the end of the outflow passage, and the free end is spherical or ellipsoidal.
5. The heart valve support of claim 1, wherein, The free end of the front side grab ear is folded outward, and the free end of the rear side grab ear is folded inward.
6. The heart valve support of claim 1, wherein, The grab ear structure is integrally formed with the stent body, or the grab ear structure and the stent body are connected by riveting, welding or buckling.
7. The heart valve support of claim 1, wherein, The two ends of the grab ear structure are fixed on the stent body, and the grab ear structure and the mesh structure units of the stent body form a closed structure.
8. The heart valve support of claim 1, wherein, The outer diameter of the proximal end port of the inflow passage is 35-75 mm, the rigidity of the inflow passage is greater than that of the outflow passage, the height of the outflow passage in the axial direction is 5-20 mm, and the outer diameter is 21-55 mm.
9. A heart valve prosthesis comprising a heart valve stent and a valve fixedly arranged on an inner surface of a main body of the stent, characterized in that, The heart valve stent is the heart valve stent according to any one of claims 1-8.
Citation Information
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Sequentially deployed transcatheter mitral valve prosthesis
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