Integrated heart valve stent capable of preventing coronary artery opening from being blocked

Abstract

The invention discloses an integrated heart valve stent capable of preventing coronary artery opening blockage, and relates to the field of heart valve stent integrated heart valve stents. The integrated heart valve stent capable of preventing the coronary artery opening from being blocked comprises a main stent body and a plurality of sets of positioning pieces used for being inserted into the sinus floor of a heart valve. The main body support comprises multiple sets of full supporting pieces and multiple sets of semi-supporting pieces which are sequentially connected, and the multiple sets of full supporting pieces which are sequentially connected are arranged between the sets of semi-supporting pieces. Coronary artery passing holes and supporting holes are formed in each group of semi-supporting pieces. And the positioning piece is connected with the full supporting piece or the semi-supporting piece. By means of the arrangement, the coronary artery opening is prevented from being blocked while the supporting force of the main body support is guaranteed, a follow-up coronary artery repairing instrument can be allowed to enter from the coronary artery passing hole, and meanwhile the risk of perivalvular leakage is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of heart valve stents, and particularly to an integrated heart valve stent for preventing coronary orifice blockage. BACKGROUND

[0002] Heart valve disease belongs to structural heart disease, and the valve often hinders normal blood flow due to abnormal stenosis or insufficiency, thereby causing functional damage to the heart. In terms of valve lesion location, the mitral valve and the aortic valve bear the most pressure and are most susceptible to disease, so the incidence of disease of these two valves is higher. At present, there are about 4.1 million patients in China with aortic valve regurgitation (AR) related diseases, of which about 15%-20% of symptomatic severe patients are the main population in need of treatment, and about 800,000 patients need to receive related treatment, and valve replacement is an extremely effective treatment method.

[0003] At present, the main way for artificial heart valve replacement is traditional surgical thoracotomy and transcatheter intervention surgery. Surgical valve replacement is the most mature treatment method, but 30% of patients cannot undergo surgical treatment due to high age, poor left ventricular function, severe comorbidities, and other reasons, and interventional valve replacement becomes an alternative choice. In recent years, transcatheter intervention therapy has the advantages of minimally invasive, low risk, and rapid recovery.

[0004] The current application is widely used for treating aortic valve regurgitation. The stent mainly includes two structures. One is a split cutting stent, which is cut into a stent body and a positioning device, and then connected by a high polymer line. The split cutting stent has poor positioning accuracy, which is not conducive to the accurate positioning of the valve. After the valve is implanted, the junction with the native valve has poor alignment, which is not conducive to the hemodynamics of the valve. In addition, the split stent also increases the consumption of the nickel-titanium tube of the single valve stent, which is not conducive to the reduction of the cost of the valve. The other structure is an integrated cutting stent. The integrated cutting stent can enhance the positioning accuracy, has strong junction alignment with the native valve, has good hemodynamic performance, and can enhance the utilization rate of the nickel-titanium tube, which is helpful to further reduce the cost of the valve. However, the positioning member of the widely used integrated cutting stent is often hollowed out from the stent body. Therefore, the part where the positioning member is located does not have a corresponding diamond grid to block the native valve leaflet. The native valve leaflet has the risk of invading the artificial valve leaflet. After the invasion, it may interfere with the opening and closing movement of the artificial valve leaflet, and then affect its long-term functionality. For example, patent US20090216310A1 discloses a <stent for positioning and anchoring a valve prosthesis in a patient's heart implant site>, which is a typical integrated cutting stent. However, due to the shortcomings and defects of the cutting process and design process, the position of the stent body corresponding to the positioning arch in the patent is hollowed out without any related shielding, which leads to the direct contact between the native valve leaflet and the artificial valve leaflet, and the risk of native valve leaflet invasion into the artificial valve leaflet and the risk of paravalvular leakage. However, if the hollowed-out position is directly filled, the coronary orifice will be blocked, resulting in poor coronary orifice. Therefore, how to reduce the risk of paravalvular leakage without blocking the coronary orifice has become a key problem.

[0005] In summary, there is an urgent need for an integrated heart valve stent that can reduce the risk of paravalvular leakage without blocking the coronary orifice. SUMMARY

[0006] To solve the above-mentioned related technical problems, the present application discloses an integrated heart valve stent for preventing coronary orifice blockage, which comprises a stent body and a plurality of positioning members for inserting into the heart valve sinus. The stent body comprises a plurality of full support members and a plurality of half support members connected in sequence, and a plurality of full support members connected in sequence are arranged between each group of half support members. The half support members are provided with a coronary through hole and a support hole. The positioning member is connected with the full support member or the half support member.

[0007] In an embodiment, the main body support includes an upper wave-shaped rod and a lower wave-shaped rod. Each group of full supports is connected to the upper wave-shaped rod and forms a plurality of first meshes. Each group of full supports and each group of half supports are connected to the lower wave-shaped rod and form a plurality of second meshes. Third meshes are formed between adjacent full supports, and third meshes are formed between adjacent full supports and half supports. Each half support is connected to the upper wave-shaped rod and forms a coronary artery passing hole, and each half support is connected to the lower wave-shaped rod and forms a support hole.

[0008] In an embodiment, each group of full supports includes a full support rod upper portion and a full support rod lower portion, and the full support rod upper portion and the full support rod lower portion are connected in the same group of full supports. Each group of half supports includes a half support rod upper portion and a half support rod lower portion, and the half support rod upper portion and the half support rod lower portion are connected in the same group of half supports. The positioning member includes a left positioning rod and a right positioning rod, and the fixed end of the left positioning rod and the fixed end of the right positioning rod are located at the connection between adjacent full supports and half supports, and the left positioning rod and the right positioning rod are not located at the same connection. In the same group, the free end of the left positioning rod is detachably connected to the free end of the right positioning rod.

[0009] In an embodiment, the upper wave-shaped rod includes a plurality of first upper wave-shaped rod segments, each first upper wave-shaped rod segment corresponds to each full support upper portion and is connected to form a plurality of first meshes, and a plurality of adjacent first upper wave-shaped rod segments correspond to each half support upper portion and are connected to form a plurality of coronary artery passing holes. The lower wave-shaped rod includes a plurality of lower wave-shaped rod segments, each lower wave-shaped rod segment corresponds to each full support lower portion and is connected to form a plurality of second meshes, and each lower wave-shaped rod segment corresponds to each half support lower portion and is connected to form a plurality of second meshes.

[0010] In an embodiment, the upper wave-shaped rod further includes a plurality of second upper wave-shaped rod segments, and a plurality of first upper wave-shaped rod segments are arranged between each second upper wave-shaped rod segment. Each second upper wave-shaped rod segment corresponds to each half support upper portion and is connected to form a plurality of coronary artery passing holes, and the height of the second upper wave-shaped rod segment is greater than that of the first upper wave-shaped rod segment.

[0011] In an embodiment, the second upper wave-shaped rod segment includes a second wave-shaped rod left segment and a second wave-shaped rod right segment, and the included angle θ between the second wave-shaped rod left segment and the second wave-shaped rod right segment ranges from 60° to 130°.

[0012] In an embodiment, the free end of each left positioning rod includes a left outwardly expanded bottom portion, and the average width of the left outwardly expanded bottom portion is greater than the average width of the left positioning rod excluding the left outwardly expanded bottom portion. The free end of each right positioning rod includes a right outwardly expanded bottom portion, and the average width of the right outwardly expanded bottom portion is greater than the average width of the right positioning rod excluding the right outwardly expanded bottom portion.

[0013] In an embodiment, the free end of each left positioning rod is provided with a left connecting hole, and the free end of each right positioning rod is provided with a right connecting hole. When the left positioning rod and the right positioning rod are connected in the same set of positioning members, the connecting rope is wound in the left connecting hole and the right connecting hole.

[0014] In an embodiment, the free end of each left positioning rod is provided with a groove, and the free end of each right positioning rod is provided with a protrusion, and the groove and the protrusion are detachably connected. When the left positioning rod and the right positioning rod are connected in the same set of positioning members, the protrusion is arranged in the groove.

[0015] In an embodiment, a plurality of developing members are sleeved on the main support and / or the positioning member.

[0016] In an embodiment, the positioning member is asymmetrically shaped, wherein the left positioning rod or the right positioning rod is a curved structure.

[0017] In an embodiment, an anchor is arranged on each lower vertex of the second grid, or the anchors are arranged at intervals on the lower vertices of the second grid.

[0018] Advantages

[0019] 1) The integrated heart valve stent for preventing coronary orifice blockage provided by the present application is provided with a main support and a plurality of sets of positioning members for inserting into the heart valve sinus bottom. A plurality of sets of full support members and a plurality of sets of half support members are sequentially connected in the main support, a plurality of sets of full support members are arranged between each set of half support members, and each set of full support member is connected with the main support. Each set of half support member is connected with the main support and forms a plurality of coronary through holes, and each set of half support member is provided with a support hole. The positioning member is connected with the full support member or the half support member. Through the above arrangement, the present application can prevent the coronary orifice from being blocked while ensuring the support force of the main support, and can allow subsequent coronary repair instruments to enter from the coronary through hole, while reducing the risk of paravalvular leakage.

[0020] 2) The positioning member in the integrated heart valve stent for preventing coronary orifice blockage provided by the present application includes a left positioning rod and a right positioning rod. The fixed end of the left positioning rod and the fixed end of the right positioning rod are arranged at the connection of each set of full support member, and the left positioning rod and the right positioning rod are arranged at different connections. The free end of the left positioning rod and the free end of the right positioning rod are detachably connected. Through the above arrangement, the present application effectively prevents the direct contact between the native leaflet and the artificial leaflet, and reduces the risk of the native leaflet invading the artificial leaflet.

[0021] 3) The free end of the left positioning rod in the integrated heart valve stent for preventing coronary orifice blockage provided by the application comprises a left outwardly expanded bottom, and the free end of the right positioning rod comprises a right outwardly expanded bottom. Through the above arrangement, when the free end of the left positioning rod and the free end of the right positioning rod are connected, the bottom of the positioning rod is flat, the sharpness of the head end of the positioning member is reduced, and the damage of the positioning member to the sinus floor is reduced. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 The structure of the integrated heart valve stent for preventing coronary orifice blockage after deployment.

[0023] Figure 2 Another structure of the integrated heart valve stent for preventing coronary orifice blockage after deployment.

[0024] Figure 3 The structure of the left connecting hole and the right connecting hole in the integrated heart valve stent for preventing coronary orifice blockage.

[0025] Figure 4 The structure of the left outwardly expanded bottom and the right outwardly expanded bottom in the integrated heart valve stent for preventing coronary orifice blockage.

[0026] Figure 5 The structure of the buckle and the slot in the integrated heart valve stent for preventing coronary orifice blockage.

[0027] Figure 6 The structure of the developing member and the fixing ring in the integrated heart valve stent for preventing coronary orifice blockage.

[0028] Figure 7 The schematic diagram of the included angle θ in the integrated heart valve stent for preventing coronary orifice blockage.

[0029] REFERENCE NUMERALS

[0030] Main stent 1

[0031] Full support 11

[0032] Full support upper part 11.1

[0033] Full support lower part 11.2

[0034] Half support 12

[0035] Half support upper part 12.1

[0036] Half support lower part 12.2

[0037] Upper wave rod 13

[0038] First upper wave section 13.1

[0039] Second upper wave section 13.2

[0040] Lower wave rod 14

[0041] Lower wave section 14.1

[0042] Positioning component 2

[0043] Left positioning rod 21

[0044] Left outward expansion at the bottom 21.1

[0045] Left connecting hole 21.2

[0046] Groove 21.3

[0047] Right positioning rod 22

[0048] Right outward expansion at the bottom 22.1

[0049] Right connecting hole 22.2

[0050] Protrusion 22.3

[0051] Developed Part 3

[0052] Anchor 4

[0053] Fixed ring 5

[0054] First mesh 801

[0055] Second mesh 802

[0056] Third mesh 803

[0057] Coronary artery perforation 901

[0058] Support hole 902 Detailed Implementation

[0059] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. In the description of the present invention, it should be noted that the terms "left side", "right side", "upper side", "lower side", "above", "below", "fixed end", "free end", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0060] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0061] Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0062] Before detailing the embodiments, some explanations are provided: The artificial aortic valve of the present invention is housed in the main support 1, and the opening direction of the artificial aortic valve is consistent with the blood flow direction L. Specifically, both the native aortic valve and the artificial aortic valve include two states: a first state of "closed state" and a second state of "open state". When blood flows through the aortic valve in the direction L, the aortic valve changes from the "closed state" to the "open state". After the blood passes through, the aortic valve changes back from the "open state" to the "closed state". In order to deliver the present invention to the designated location of the aortic valve through the aorta, the device is in a "gripping" state during the transportation process using a catheter. The overall radius of the device is small and the arrangement of the various structures is relatively close. When the device reaches the designated location, the catheter controls the device to expand outward and enter the "expanded" state. The "expanded" state of the device is the final working state.

[0063] Furthermore, the integrated cardiac valve stent for preventing coronary artery ostial blockage described in this invention is a stent that carries an artificial aortic valve, capable of carrying the artificial aortic valve and fixing it in the position of the native aortic valve. In use, firstly, the positioning element 2 is inserted into the sinus base of the native aortic valve, at which point each native aortic valve should be located between the positioning element 2 and the main stent 1. Secondly, the main stent 1 is released, causing it to expand and compress the native aortic valve, thus rendering it ineffective. At this point, the replacement of the native aortic valve with the artificial aortic valve is complete, and the artificial aortic valve replaces the native aortic valve in achieving "opening" and "closing".

[0064] Example 1

[0065] This embodiment provides an integrated cardiac valve stent to prevent coronary artery ostium blockage. (See attached document.) Figure 1 The system includes a main stent 1 and multiple sets of positioning elements 2 for insertion into the sinus base of the heart valves. The main stent 1 contains multiple sets of full support elements 11 and multiple sets of semi-support elements 12 connected sequentially. Multiple sets of full support elements 11 are positioned between each set of semi-support elements 12. The number of full support elements 11 between each set of semi-support elements 12 should not be limited, but generally, two sets of full support elements 11 are provided between each set of semi-support elements 12. The spacing of two sets of full support elements 11 between each set of semi-support elements 12 ensures that the size of the main stent 1 after expansion is not excessive, while also ensuring sufficient support after expansion. (Continue reading...) Figure 1 Each set of full support members 11 is connected to the main support 1, and each set of semi-support members 12 is connected to the main support 1, forming multiple coronary artery passage holes 901. Each semi-support member 12 has a support hole 902. It is worth noting that the coronary artery passage holes 901 prevent the semi-support members 12 from obstructing the coronary ostium, ensuring the patency of the coronary ostium, and allowing subsequent coronary artery repair instruments to enter through the coronary artery passage holes 901. Preferably, see [reference needed]. Figure 1There are three semi-support members 12 and three coronary artery passage holes 901. When using this device, only one coronary artery orifice needs to be aligned with one of the coronary artery passage holes 901. The three coronary artery passage holes 901 make the structure of the main stent 1 more symmetrical, preventing the center of gravity from shifting. In addition, the support holes 902 have two main functions: 1) As a shielding element, they prevent blood from flowing back through the coronary artery passage holes 901, effectively reducing paravalvular leakage. 2) As an expansion element, when the artificial aortic valve is in the target position but not yet released, the main stent 1 is in a "gripped" state, and the support holes 902 are also in a "gripped" state. During the expansion of the main stent 1 from the "gripped" state, the support holes 902 provide a certain expansion force, allowing the main stent 1 to expand fully and rapidly, while simultaneously pushing the positioning member 2 to open outward more quickly, making it easier for the positioning member 2 to cross the native aortic valve and thus more smoothly insert into the base of the native aortic valve sinus. (Continue reading...) Figure 1 Positioning element 2 is connected to full support element 11 or semi support element 12. As described above, positioning element 2 is used to insert into the base of the native aortic valve sinus. The number of positioning elements 2 matches the number of native aortic valves in the patient. Normally, there are three positioning elements 2, but if the patient has defects in only two native aortic valves, the number of positioning elements 2 is set to two.

[0066] In one specific embodiment, see Figure 1 The main support 1 includes an upper wave bar 13 and a lower wave bar 14. Each set of full support members 11 is connected to the upper wave bar 13 to form multiple first grids 801. That is, each full support member 11 is individually connected to the upper wave bar 13 to form a first grid 801, and the number of first grids 801 is equal to the number of full support members 11. Each set of full support members 11 and each set of half support members 12 are connected to the lower wave bar 14 to form multiple second grids 802. That is, each full support member 11 or half support member 12 is individually connected to the lower wave bar 14 to form a second grid 802, and the number of second grids 802 is equal to the sum of the number of full support members 11 and half support members 12. A third grid 803 is formed between adjacent full support members 11 and between adjacent full support members 11 and half support members 12. The number of third grids 803 is equal to the sum of the number of full support members 11 and half support members 12. (Continue reading...) Figure 1 Each set of semi-support members 12 is connected to the upper wave rod 13 to form a coronary artery passage hole 901. That is to say, each semi-support member 12 is individually connected to the upper wave rod 13 to form a coronary artery passage hole 901, and the number of coronary artery passage holes 901 is equal to the number of semi-support members 12.

[0067] In one specific embodiment, see Figure 1Each set of full support components 11 includes an upper part 11.1 and a lower part 11.2 of the full support rod. Within the same set of full support components 11, the upper part 11.1 and the lower part 11.2 of the full support rod are connected. For details, please refer to [link / reference]. Figure 1 The full support member 11 is X-shaped, while the upper part 11.1 and the lower part 11.2 of the full support rod are both V-shaped. The upper part 11.1 of the full support rod has an upward-opening V-shape, and the lower part 11.2 of the full support rod has a downward-opening V-shape. (See reference...) Figure 1 Each set of semi-support members 12 includes an upper part 12.1 and a lower part 12.2 of a semi-support rod. Within the same set of semi-support members 12, the upper part 12.1 and the lower part 12.2 of the semi-support rod are connected. For details, please refer to [link / reference]. Figure 1 Both the upper part 12.1 and the lower part 12.2 of the semi-support rod are W-shaped. The upper part 12.1 of the semi-support rod is an upward-opening W-shape, and the lower part 12.2 of the semi-support rod is a downward-opening W-shape. The upper part 12.1 and the lower part 12.2 of the semi-support rod are connected to form a support hole 902.

[0068] Before describing the positioning element 2, a brief explanation of the manufacturing process of heart valve stents is needed: Although heart valve stents are in an "expanded" state, i.e., ring-shaped, current heart valve stent manufacturing involves cutting and carving on a metal tube. This means the laser cutting pattern for the heart valve stent is planar, and a circle is cut around the metal tube according to this plane to form the main stent. Therefore, this manufacturing method means that if the positioning element 2 remains connected, the overlapping portion must be hollowed out during manufacturing to ensure that the positioning element 2 can be cut. This large-area hollowing increases the risk of potential paravalvular leakage and the risk of the native leaflet invading the artificial leaflet. Therefore, this invention designs a positioning element 2 to solve the above problems. (See reference...) Figure 1 The positioning component 2 includes a left positioning rod 21 and a right positioning rod 22. The fixed ends of both the left and right positioning rods 22 are located at the connection points of adjacent full support members 11 and half support members 12, but the connection points of the left and right positioning rods 21 and 22 are different. Within the same group, the free ends of the left and right positioning rods 21 and 22 are detachably connected. Through this design, the present invention effectively prevents direct contact between the native leaflet and the artificial leaflet, reducing the risk of the native leaflet invading the artificial leaflet.

[0069] Next, some specific embodiments are provided to illustrate the "detachable connection between the free end of the left positioning rod 21 and the free end of the right positioning rod 22" mentioned above: First, refer to Figure 3Each left positioning rod 21 has a left connecting hole 21.2 on its free end, and each right positioning rod 22 has a right connecting hole 22.2 on its free end. In the same group of positioning components 2, when the left positioning rod 21 is connected to the right positioning rod 22, the connecting rope is wound around the left connecting hole 21.2 and the right connecting hole 22.2. Additionally, the size of the left connecting hole 21.2 and the right connecting hole 22.2 should be approximately equal to the thickness of the connecting rope to ensure connection strength and prevent the connecting rope from swaying within the left connecting hole 21.2 and the right connecting hole 22.2. (See the second option.) Figure 4 Each left positioning rod 21 has a groove 21.3 on its free end, and each right positioning rod 22 has a protrusion 22.3 on its free end. The grooves 21.3 and protrusions 22.3 are detachably connected. In the same group of positioning components 2, when the left positioning rod 21 and the right positioning rod 22 are connected, the protrusion 22.3 is located in the groove 21.3. Alternatively, the groove 21.3 can also be located on the right positioning rod 22, and the protrusion 22.3 can also be located on the left positioning rod 21. As a supplement, the groove 21.3 can be teardrop-shaped, pentagonal-shaped, or triangular, and the protrusion 22.3 can also be teardrop-shaped, pentagonal-shaped, or triangular, etc.

[0070] In a supplementary embodiment, the connection between the left positioning rod 21 and the right positioning rod 22 may also be wrapped with a film. On the one hand, wrapping with film can ensure the stability of the connection. On the other hand, wrapping with film can increase the imaging effect under ultrasound.

[0071] In another supplementary embodiment, see [link to supplementary embodiment]. Figure 5 Each left positioning rod 21 has a left outwardly flared bottom 21.1 on its free end. The average width of the left outwardly flared bottom 21.1 is greater than the average width of the left positioning rod 21 that does not include the left outwardly flared bottom 21.1. (Continue reading...) Figure 4 Each right positioning rod 22 has a right outwardly flared bottom 22.1 on its free end. The average width of the right outwardly flared bottom 22.1 is greater than the average width of the right positioning rod 22 that does not include the right outwardly flared bottom 22.1. This design allows for a smoother connection between the left positioning rod 21 and the right positioning rod 22, reducing damage to the sinus floor of the heart valve when the positioning element 2 is inserted, while also improving stability.

[0072] In one specific embodiment, see Figure 1 The upper wave bar 13 includes multiple first upper wave bar segments 13.1 connected in sequence. Each first upper wave bar segment 13.1 corresponds one-to-one with the upper part 11.1 of each full support member and is connected to form multiple first grids 801. (Continue reading...) Figure 1Multiple adjacent first upper wave bar segments 13.1 are connected to the upper part 12.1 of each half-support member to form multiple coronary artery passage holes 901. Generally, two adjacent first upper wave bars 13.1 are connected to the upper part 12.1 of one half-support member to form one coronary artery passage hole 901. See reference. Figure 1 The lower wave bar 14 includes multiple lower wave bar segments 14.1, each lower wave bar segment 14.1 is connected to the lower part 11.2 of each full support member to form multiple second grids 802, and each lower wave bar segment 14.1 is connected to the lower part 12.2 of each half support member to form multiple second grids 802.

[0073] In one specific embodiment, see Figure 2 The upper wave bar 13 also includes multiple second upper wave bar segments 13.2, with multiple first upper wave bar segments 13.1 between each second upper wave bar segment 13.2. Generally, there are two first upper wave bar segments 13.1 between each second wave bar segment 13.2. It is worth noting that the number of full support members 11 between each semi-support member 12 should be consistent with the number of first upper wave bar segments 13.1 between each second upper wave bar segment 13.2. (Continue reading...) Figure 2 Each second upper wave bar segment 13.2 corresponds one-to-one with and connects to the upper part 12.1 of each semi-support member to form multiple coronary artery passage holes 901. Compared with the scheme where the coronary artery passage hole 901 is formed by multiple adjacent first upper wave bars 13.1 and the upper part 12.1 of the semi-support member, the use of the second upper wave bar segment 13.2 and the upper part 12.1 of the semi-support member to form the coronary artery passage hole 901 can effectively reduce the excessive expansion force generated by multiple adjacent first upper wave bars 13.1, thereby reducing the impact on the original heart valve caused by the main stent 1 during the expansion process due to excessive expansion force, and reducing the risk of accidental expansion when the main stent 1 is in the closed stage. In a preferred embodiment, referring to Figure X, the second upper wave bar segment 13.2 can extend upward and exceed the height of the first upper wave bar segment 13.1, thereby further reducing the expansion force of the second upper wave bar segment 13.2.

[0074] In one specific embodiment, the first upper wave section 13.1, the second upper wave section 13.2, and the lower wave section 14.1 are V-shaped, with the first upper wave section 13.1 and the second upper wave section 13.2 forming an upward-opening V-shape, and the lower wave section 14.1 forming a downward-opening V-shape. Then, continue referring to... Figure 2The first grid 801, the second grid 802, and the third grid 803 are all rhomboid in shape. The first grid 801 is a rhomboid with a shorter top and a longer bottom, the second grid 802 is a rhomboid of equal length, and the third grid 803 is a rhomboid with a longer top and a shorter bottom. This arrangement ensures that the first grid 801, the second grid 802, and the third grid 803 provide a certain amount of support while maintaining appropriate expansion force, thus guaranteeing the smooth expansion of the main support 1.

[0075] In one specific embodiment, see Figure 7 The second upper wave section 13.2 includes a left section and a right section, with an included angle θ between them of 60° to 130°. Preferably, the included angle θ is 80° to 110°. With this configuration, the second upper wave section 13.2 can provide greater radial support force after the main support 1 expands. In a preferred embodiment, the height of the second upper wave section 13.2 does not exceed the height of the first upper wave section 13.1, to further provide radial support force after the main support 1 expands.

[0076] In one specific embodiment, see Figure 1 and Figure 2 Anchoring elements 4 are provided on all lower wave-shaped sections 14.1. Alternatively, anchoring elements 4 are provided at intervals on lower wave-shaped sections 14.1. Alternatively, anchoring elements 4 are provided on lower wave-shaped sections 14.1 connected to the lower part 11.2 of the full support member. Alternatively, anchoring elements 4 are provided on lower wave-shaped sections 14.1 connected to the lower part 11.2 of the semi-support member. By providing anchoring elements 4 on lower wave-shaped sections 14.1 as described above, the anchoring elements 4 can contact and penetrate the native heart valve after the main stent 1 expands, further improving the stability of the main stent 1.

[0077] In one specific embodiment, see Figure 6 Multiple developing elements 3 are sleeved on the main support 1 or positioning element 2. Preferably, multiple developing elements 3 are sleeved on the positioning element 2. Alternatively, refer to [link to relevant documentation]. Figure 6 The upper wave bar 13 is equipped with multiple retaining rings 5. Alternatively, see [reference needed]. Figure 1 and Figure 2 The positioning element 2 is asymmetrical in shape, wherein the left positioning rod 21 or the right positioning rod 22 is a curved structure.

[0078] This embodiment also provides a method of using the integrated cardiac valve stent for preventing coronary artery ostium blockage described in this invention, as follows: 1) Insert a catheter into the main stent 1 and make the main stent 1 fit against the catheter, so that the main stent 1 is in a crimped state. 2) After the catheter transports the main stent 1 to the aortic valve, the positioning element 2 is aligned with each aortic valve and inserted to the bottom of each aortic valve sinus. 3) At this time, the aortic valve should be located between the main stent 1 and the positioning element 2. Then, release the main stent 1, causing it to expand. 4) Align one of the coronary arteries through the orifice 901 with the coronary foramen. After the main stent 1 expands, the artificial valve located in the main stent 1 begins to function. Thus, the replacement of the original cardiac valve is completed.

[0079] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make several improvements and substitutions without departing from the technical principles of the present invention, and these improvements and substitutions should also be considered within the scope of protection of the present invention.

Claims

1. An integrated cardiac valve stent for preventing coronary artery ostium blockage, characterized in that: It includes a main support (1) and multiple positioning devices (2) for insertion into the sinus base of the heart valve; The main support (1) is provided with multiple sets of full support members (11) and multiple sets of semi support members (12) connected in sequence. Multiple sets of full support members (11) are provided between each set of semi support members (12). Each set of full support members (11) is connected to the main support (1). Each set of semi support members (12) is connected to the main support (1) and forms multiple coronary artery passage holes (901). Each set of semi support members (12) is provided with support holes (902). The positioning element (2) is connected to the full support element (11) or the half support element (12).

2. The integrated cardiac valve stent for preventing coronary artery ostium blockage according to claim 1, characterized in that: The main support (1) includes an upper wave bar (13) and a lower wave bar (14); Each set of full support members (11) is connected to the upper wave bar (13) to form multiple first grids (801); each set of full support members (11) and each set of half support members (12) are connected to the lower wave bar (14) to form multiple second grids (802); a third grid (803) is formed between adjacent full support members (11) and between adjacent full support members (11) and half support members (12); Each of the semi-support members (12) is connected to the upper wave bar (13) and forms a coronary artery passage hole (901).

3. The integrated cardiac valve stent for preventing coronary artery ostium blockage according to claim 2, characterized in that: Each group of full support members (11) includes an upper part (11.1) and a lower part (11.2) of a full support rod. In the same group of full support members (11), the upper part (11.1) and the lower part (11.2) of the full support rod are connected. Each group of half support members (12) includes an upper part (12.1) and a lower part (12.2) of a half support rod. In the same group of half support members (12), the upper part (12.1) and the lower part (12.2) of the half support rod are connected to form a support hole (902). The positioning component (2) includes a left positioning rod (21) and a right positioning rod (22). The fixed ends of the left positioning rod (21) and the right positioning rod (22) are both located at the connection points of the adjacent full support component (11) and the half support component (12), and the connection points of the left positioning rod (21) and the right positioning rod (22) are not the same. In the same group, the free end of the left positioning rod (21) and the free end of the right positioning rod (22) are detachably connected.

4. The integrated cardiac valve stent for preventing coronary artery ostium blockage according to claim 3, characterized in that: The upper wave bar (13) includes a plurality of first upper wave bar segments (13.1) connected in sequence. Each first upper wave bar segment (13.1) corresponds one-to-one with the upper part (11.1) of each full support member and is connected to form a plurality of first grids (801). A plurality of adjacent first upper wave bar segments (13.1) are connected to the upper part (12.1) of each half support member to form a plurality of coronary artery passage holes (901). The lower wave bar (14) includes multiple lower wave bar segments (14.1), each of the lower wave bar segments (14.1) is connected one-to-one with the lower part (11.2) of each full support member to form multiple second grids (802), and each of the lower wave bar segments (14.1) is connected one-to-one with the lower part (12.2) of each half support member to form multiple second grids (802).

5. The integrated cardiac valve stent for preventing coronary artery ostium blockage according to claim 4, characterized in that: The upper wave bar (13) also includes a plurality of second upper wave bar segments (13.2), and a plurality of first upper wave bar segments (13.1) are provided between each second upper wave bar segment (13.2); Each of the second upper wave bar segments (13.2) corresponds one-to-one with the upper part (12.1) of each of the semi-support members and is connected to form a plurality of coronary artery passage holes (901).

6. The integrated cardiac valve stent for preventing coronary artery ostium blockage according to claim 5, characterized in that: The second upper wave bar segment (13.2) includes a second wave bar left segment and a second wave bar right segment, and the included angle θ between the second wave bar left segment and the second wave bar right segment is 60° to 130°.

7. The integrated cardiac valve stent for preventing coronary artery ostial blockage according to claim 3, characterized in that: The free end of each of the left positioning rods (21) includes a left outwardly flared bottom (21.1), the average width of which is greater than the average width of the left positioning rod (21) without the left outwardly flared bottom (21.1); the free end of each of the right positioning rods (22) includes a right outwardly flared bottom (22.1), the average width of which is greater than the average width of the right positioning rod (22) without the right outwardly flared bottom (22.1).

8. The integrated cardiac valve stent for preventing coronary artery ostium blockage according to claim 3, characterized in that, It also includes any one of the following technical features: a) Each of the left positioning rods (21) has a left connecting hole (21.2) on its free end, and each of the right positioning rods (22) has a right connecting hole (22.2) on its free end; in the same group of positioning components (2), when the left positioning rod (21) and the right positioning rod (22) are connected, the connecting rope is wrapped in the left connecting hole (21.2) and the right connecting hole (22.2); b) Each of the left positioning rods (21) has a groove (21.3) on its free end, and each of the right positioning rods (22) has a protrusion (22.3) on its free end. The groove (21.3) and the protrusion (22.3) are detachably connected. In the same group of positioning components (2), when the left positioning rod (21) and the right positioning rod (22) are connected, the protrusion (22.3) is located in the groove (21.3).

9. The integrated cardiac valve stent for preventing coronary artery ostium blockage according to claim 3, characterized in that, It also includes any one of the following technical features: a) Multiple developing elements (3) are sleeved on the main support (1) and / or positioning element (2); b) The positioning element (2) is asymmetrical in shape, wherein the left positioning rod (21) or the right positioning rod (22) is a curved structure; c) The upper wave bar (13) is provided with multiple fixing rings (5).

10. The integrated cardiac valve stent for preventing coronary artery ostium blockage according to claim 4, characterized in that: An anchor (4) is provided on the lower wave section (14.1), and the anchor (4) satisfies any of the following technical features: a) The anchoring element (4) is provided on each of the lower wave bar sections (14.1); b) The anchoring element (4) is provided at intervals on the lower wave bar segment (14.1); c) The anchor (4) is provided on the lower wave bar section (14.1) connected to the lower part (11.2) of the full support member; d) The anchor (4) is provided on the lower wave bar segment (14.1) connected to the lower part (11.2) of the semi-support member.

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