Reflux valve stent

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a reflux valve stent. A reflux valve support comprises a plurality of retaining parts and a plurality of positioning parts, one retaining part corresponds to one positioning part, the outflow end of each positioning part is fixedly connected with the outflow end of the corresponding retaining part, and the inflow end of each retaining part is provided with an anchoring part; a plurality of barbs are arranged in the circumferential direction of the anchoring part, and the free ends of the barbs are opposite to the inflow end of the positioning piece. According to the design that the inflow end of the positioning piece corresponds to the barbs, the inflow end of the positioning piece and the barbs clamp the aortic valve ring at two opposite positions in the axial direction, a two-way fixing structure is achieved, and the purpose that the aortic valve ring is well clamped through the positioning piece and the barbs is effectively achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a regurgitant valve stent. Background Art

[0002] Aortic valve regurgitation refers to the aortic valve located between the left ventricle and the aorta. It opens when the ventricle contracts, and the blood in the left ventricle enters the aorta and flows to the whole body. It closes when the ventricle relaxes, preventing the blood in the aorta from flowing back into the left ventricle. If aortic regurgitation occurs, the aortic valve cannot close tightly during diastole, causing blood to flow back from the aorta into the left ventricle.

[0003] The Chinese patent "A kind of aortic regurgitant valve stent with a flexible positioning part" (publication number: CN115624416A) provides an aortic regurgitant valve stent, the movement of the valve away from the ventricle is mainly restricted by the anchoring part to engage the aortic valve ring, which is unstable. Summary of the invention

[0004] The present invention aims to provide a regurgitant valve stent in view of the technical problem that the existing aortic regurgitant valve stent mainly relies on an anchoring portion to engage the aortic valve ring, and the stent fixation is unstable.

[0005] In order to solve the above technical problems, the first aspect of the present invention provides a regurgitant valve stent, comprising a plurality of retaining members and a plurality of positioning members, wherein one retaining member is provided with a corresponding positioning member, and an outflow end of the positioning member is fixedly connected to an outflow end of the retaining member;

[0006] The inflow end of the positioning member is a wave rod structure in a compressed state and is located on the upper side of the inflow end of the retaining member;

[0007] The inflow end of the positioning member extends to the outside of the retaining member and crosses the inflow end of the retaining member in an expanded state.

[0008] Optionally, in the regurgitant valve stent as described above, the inflow end of the positioning member is covered with a positioning member coating.

[0009] Optionally, in the aforementioned regurgitant valve stent, the covering membrane is respectively connected to the positioning rods on both sides of the inflow end of the positioning member by sutures.

[0010] Optionally, in the aforementioned regurgitant valve stent, a wire pull ring is provided on the inner side of the inflow end of the positioning member, and the wire pull ring is connected to the inflow end of the positioning member via a connecting rod;

[0011] The covering film is respectively connected to the positioning rods on both sides of the inflow end of the positioning member and the connecting rod through sutures.

[0012] Optionally, in the regurgitant valve stent as described above, the middle portion of the membrane is fixed by passing sutures through the pull wire ring.

[0013] Optionally, in the aforementioned regurgitant valve stent, a polymer film is provided between the coating and the positioning member, so that a double-layer coating structure is formed at the inflow end of the positioning member.

[0014] Optionally, in the aforementioned regurgitant valve stent, the covering membrane is animal tissue, and the animal tissue is preferably bovine pericardium or porcine pericardium, etc.

[0015] Optionally, in the aforementioned regurgitant valve stent, the polymer membrane is made of PET, ePTFE or FEP.

[0016] Optionally, in the aforementioned regurgitant valve stent, in the expanded state, the axial distance from the inflow end of the positioning member to the inflow end of the regurgitant valve stent does not exceed 15 mm, preferably 6 mm to 10 mm.

[0017] Optionally, the width of the middle portion of the barb is greater than the width of both ends of the barb.

[0018] Optionally, in the regurgitant valve stent as described above, in a compressed state, the middle portion of the inflow end of the positioning member is a bent structure, and both sides of the bent structure have at least another bent structure to form a wave rod structure.

[0019] In order to solve the above technical problems, the second aspect of the present invention provides a regurgitant valve stent, comprising a plurality of retaining members and a plurality of positioning members, wherein one retaining member is provided with a corresponding positioning member, the outflow end of the positioning member is fixedly connected to the outflow end of the retaining member, and the inflow end of the retaining member is provided with the anchoring portion;

[0020] A plurality of barbs are arranged on the circumference of the anchoring portion, and the free ends of the barbs are arranged opposite to the inflow end of the positioning member.

[0021] Optionally, in the aforementioned regurgitant valve stent, the axial distance between the inflow end of the positioning member and the free end of the barb is H, wherein 1mm≤H≤6mm, preferably 2mm≤H≤4mm.

[0022] Optionally, in the aforementioned regurgitant valve stent, the length of the barb is not less than 1.0 mm, and the length of the barb is preferably not less than 2 mm.

[0023] Optionally, in the aforementioned regurgitant valve stent, the inflow end of the barb is connected to the anchoring portion as a fixed end, and the outflow end of the barb is arranged opposite to the inflow end of the positioning member as a free end.

[0024] Optionally, in the regurgitant valve stent as described above, the fixed end of the barb is inclined outward, and the free end of the barb is inclined inward relative to the fixed end to remain parallel to the axis of the regurgitant valve stent.

[0025] Optionally, in the aforementioned regurgitant valve stent, the fixed end of the barb is inclined outward by 7° to 15°.

[0026] Optionally, in the regurgitant valve stent as described above, the fixed end of the barb is tilted outward to a middle position and then tilted inward to a free end of the barb.

[0027] Optionally, the number of groups of the barbs is consistent with the number of the positioning elements;

[0028] A group of the barbs comprises a plurality of barbs, and a free end of at least one barb in the same group is arranged opposite to the inflow end of the positioning member.

[0029] Optionally, the outer diameter of the middle portion of the anchoring portion is larger than the outer diameter of the outflow end of the anchoring portion and the outer diameter of the inflow end of the anchoring portion, so that the anchoring portion forms a middle outward expansion structure;

[0030] The inflow end of the barb is arranged as a fixed end at the middle outward expansion structure of the anchoring part.

[0031] Optionally, the anchoring portion is formed by connecting a plurality of diamond-shaped grids with their middle portions expanding outwards in a circumferential direction;

[0032] The inflow end of the barb is arranged at the connection of two adjacent diamond-shaped grids.

[0033] The positive and progressive effects of the present invention are:

[0034] 1. The inflow end of the positioning piece is a wave-bar structure in the compressed state, and in the expanded state after expansion, the wave-bar structure opens to form a larger inflow end of the positioning piece. The larger inflow end of the positioning piece increases the contact area between the positioning piece and the bottom of the aortic valve sinus, so that when the stent is subjected to force in the direction of the ventricle, the inflow end of the positioning piece can effectively disperse the force, thereby preventing the problem of aorta puncture caused by the sharp inflow end of the positioning piece.

[0035] Since the positioning member and the retaining member need to cooperate to effectively capture the native valve leaflet, the inflow end of the positioning member cannot be closer to the inflow end of the stent than the inflow end of the retaining member, and the length from the inflow end of the positioning member to the inflow end of the stent cannot be too large, otherwise the stent will extend greatly into the ventricular outflow tract, resulting in limited axial length of the anchoring portion, limiting the space of the anchoring portion structure. The wavy line structure at the inflow end of the positioning member allows the inflow end of the positioning member to extend across the inflow end of the retaining member after the stent is expanded. Therefore, while ensuring the length from the inflow end of the positioning member to the inflow end of the stent, a larger space is created for the setting of the anchoring portion.

[0036] 2. In order to reduce the damage caused by the impact of the inflow end of the positioning piece on the aortic sinus bottom, the inflow end of the positioning piece is coated with a film.

[0037] The coating is preferably connected to the inflow end of the positioning piece through sutures, but the sutures are respectively arranged on the positioning rods and / or connecting rods of the pull wire ring on both sides of the inflow end of the positioning piece. The sutures do not fix the coating through the wave rod structure at the inflow end of the positioning piece, which is beneficial to the bending deformation of the wave rod structure.

[0038] In order to prevent the coating from sliding toward the inflow end of the positioning member, the middle part of the coating is fixed by passing a suture thread through a wire ring, thereby preventing the coating from sliding axially.

[0039] In order to prevent the stent from wearing the coating, a polymer film is provided on the inner side of the coating, which effectively prevents the stent from wearing the coating. The coating and the polymer film form a double-layer coating structure to cover the inflow end of the positioning piece, thereby increasing the elasticity of the inflow end of the positioning piece and further reducing the damage of the inflow end of the positioning piece to the aortic sinus floor.

[0040] 3. The design of the corresponding arrangement of the inflow end of the positioning piece and the barbs, the two clamp the aortic valve ring at two relative positions in the axial direction, realize a bidirectional fixed structure, and effectively realize the purpose of better clamping the aortic valve ring by the positioning piece and the barbs. Compared with clamping the aortic valve leaflets, the leaflets can shake, so the position of the leaflets is not unique, so the stent can still shake with the shaking of the leaflets, while the position of the valve ring is stable and will not shake, so the present invention uses the cooperation of the positioning piece and the barbs to clamp the aortic valve ring, and realizes the firm fixation of the stent. Secondly, it is clinically found that in the case of the aortic valve leaflets (normally three-leaflet valves) with two-leaflet valves, four-leaflet valves or deformed valves, the positioning piece may need to be inserted obliquely into the aortic sinus. At this time, the leaflets are not conducive to clamping, and the cooperation of the positioning piece and the barbs can also realize the firm fixation of the stent in the case of two-leaflet valves, four-leaflet valves or deformed valves.

[0041] 4. The barbs are structured to tilt outwards from the inflow end to the outflow end and then tilt inwards until they are parallel to the axis of the regurgitant valve stent. The advantages are:

[0042] When blood passes through the stent, it will cause the stent to shake. At this time, the barbs that are only tilted outwards will find it difficult to provide circumferential riveting force to the stent. Therefore, the barbs that are only tilted outwards may be pulled out, and then repeatedly inserted into human tissue, causing damage to the aortic valve ring. After the barbs that are tilted inwards are inserted into human tissue, their free ends remain parallel to the axis of the stent, so they can provide a circumferential riveting force for the stent, allowing the aortic valve ring and the anchoring part to fit effectively, which not only prevents the circumferential shaking of the stent, but also reduces paravalvular leakage between the aortic valve ring and the anchoring part.

[0043] If the barbs that are only tilted outward cannot be fully inserted into human tissue, when the stent is subjected to axial force, the barbs are easy to scratch and tear human tissue. However, the free ends of the barbs that are relatively tilted inward will not scratch and tear human tissue because the free ends are basically parallel to the axis of the stent. Moreover, when the heart is in the systolic phase and the stent is subjected to force in the direction of the aorta, the barbs can be inserted deeper into the human tissue and can fix the stent more securely. On the contrary, when the heart is in the diastolic phase and the stent is subjected to force in the direction of the ventricle, due to the limitation of the positioning member, the stent will not move in the direction of the ventricle in large quantities. Since the free ends of the barbs are parallel to the axis of the stent, the sliding of the barbs at this time will not completely separate the barbs from the inserted human tissue, so the barbs will not be repeatedly pulled out and then inserted into the human body.

[0044] Since the anchoring portion needs to be compressed and placed in the loading chamber, and the barbs that are only inclined outward have their free ends always facing outward and pointing to the outflow end, when the loading chamber moves toward the inflow end relative to the stent, the relatively sharp free ends of the barbs are very easy to be inserted into the loading chamber, causing the loading chamber to be unable to move smoothly, making it impossible to release the anchoring portion of the stent, and further causing difficulty in or even failure to release the inflow end of the stent, seriously threatening the life and health of the implantee. In the present invention, the barbs with free ends inclined inward can be retracted so that the free ends of the barbs point to the stent and contact the loading chamber with the middle parts of the barbs. At this time, the free ends of the barbs will not contact the loading chamber, thereby not affecting the axial movement of the loading chamber, which is beneficial to the smooth release of the anchoring portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The disclosure of the present invention will become more apparent with reference to the accompanying drawings. It should be understood that these drawings are only for illustrative purposes and are not intended to limit the scope of protection of the present invention. In the drawings:

[0046] FIG. 1( a ) is a schematic structural diagram of a regurgitant valve stent in an expanded state according to an embodiment of the present invention;

[0047] FIG1( b ) is a partial enlarged view of FIG1( a );

[0048] FIG2( a ) is a schematic structural diagram of a regurgitant valve stent in a compressed state according to an embodiment of the present invention;

[0049] FIG2( b ) is a front view of FIG2( a );

[0050] FIG2(c) is a partial enlarged view of FIG2(a);

[0051] Figure 3 This is a schematic diagram of an expanded state of a regurgitant valve stent according to an embodiment of the present invention;

[0052] Figure 4 A partial structural diagram of the inflow end of the positioning member in an embodiment of the present invention covered with a coating;

[0053] Figure 5 A cross-sectional view of an embodiment of the present invention in which the inflow end of the positioning member is coated with a double-layer coating structure;

[0054] FIG6( a ) is another schematic diagram of the structure of the regurgitant valve stent in an expanded state according to an embodiment of the present invention;

[0055] FIG6( b ) is a partial enlarged view of FIG6( a );

[0056] Figure 7 A schematic diagram of an application of an embodiment of the present invention;

[0057] FIG8( a ) is another schematic diagram of the structure of the regurgitant valve stent in an expanded state according to an embodiment of the present invention;

[0058] FIG8( b ) is a partial enlarged view of FIG8( a );

[0059] FIG8( c ) is a schematic diagram of FIG8( a ) in an unfolded state;

[0060] FIG9( a ) is a schematic diagram of a structure of a leak-proof membrane in an embodiment of the present invention;

[0061] FIG9( b ) is a schematic diagram of a structure in which an inner anti-leakage membrane is provided inside the inflow end of the retaining member in an embodiment of the present invention;

[0062] FIG9(c) is a schematic diagram of a structure in which an outer anti-leakage membrane is added to the outer side of the inflow end of the retaining member in an embodiment of the present invention;

[0063] FIG9( d ) is a schematic diagram of a structure in which a coating is provided on the anchoring portion in an embodiment of the present invention;

[0064] FIG10( a ) is another schematic diagram of the structure of the regurgitant valve stent in an expanded state according to an embodiment of the present invention;

[0065] FIG10( b ) is a schematic diagram of a structure in which a coating is provided on the inner side of FIG10( a ) and an inner anti-leakage film is provided on the inner side of the inflow end of the retaining member;

[0066] FIG10( c ) is a schematic diagram of a structure in which a coating is provided on the inner side of FIG10( a ) and an outer anti-leakage film is provided on the outer side of the inflow end of the retaining member;

[0067] FIG. 11( a ) is a schematic diagram of a positioning member of a regurgitant valve stent according to an embodiment of the present invention being aligned with a native aortic valve leaflet and inserted into the aortic sinus;

[0068] FIG11( b ) is a schematic diagram of the anchoring portion of the regurgitant valve stent after being released and expanded in an embodiment of the present invention;

[0069] FIG11( c ) is a schematic diagram of a positioning member of a regurgitant valve stent according to an embodiment of the present invention opened at a certain angle;

[0070] FIG12( a ) is a schematic diagram of the structure of a sheath system, a delivery system and a regurgitant valve stent in an embodiment of the present invention;

[0071] FIG12( b ) is a schematic structural diagram of the delivery system of the present invention in FIG12( a ) with the ear-hanging covering tube removed from the distal end portion;

[0072] FIG12( c ) is a schematic structural diagram of the regurgitant valve stent in the delivery system of the present invention shown in FIG12( a ) being completely released;

[0073] Fig.13 It is a schematic structural diagram of the distal end portion of the delivery system in another embodiment of the present invention. DETAILED DESCRIPTION

[0074] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0075] It should be noted that the following embodiments and features therein may be combined with each other if there is no conflict.

[0076] In the description of the present invention, it should be noted that directional words such as the terms "outside", "middle", "inside", "outside", etc., which indicate directions and positional relationships, are based on the directions or positional relationships shown in the drawings. They 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 direction, be constructed and operated in a specific direction, and cannot be understood as limiting the specific protection scope of the present invention.

[0077] In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. Therefore, the definition of "first" and "second" features can explicitly or implicitly include one or more of the features. In the description of the present invention, "several" and "a number" mean two or more, unless otherwise clearly and specifically defined.

[0078] In the description of the present invention, it should be noted that the height direction is substantially along the direction of the axis of the regurgitant valve stent. In addition to the specific description as shown in the figure, the high, low, up, down, etc. directly mentioned in this article, the "high" and "up" refer to the position of the outflow end of the regurgitant valve stent close to the expanded state (as shown in Figure 1 (a)), and the "low" and "down" refer to the position of the inflow end of the regurgitant valve stent close to the expanded state. The "inflow end" refers to the upstream position according to the direction of blood flow, that is, the end of the stent through which blood first passes when in the expanded state, such as the inflow end 10000 shown in Figure 1 (a); the "outflow end" refers to the downstream position according to the direction of blood flow, that is, the end of the stent when the blood leaves the expanded state, such as the outflow end 20000 shown in Figure 1 (a).

[0079] Embodiment 1:

[0080] 1(a), 2(a) and 2(b), an embodiment of the present invention provides a regurgitant valve stent, comprising a plurality of retaining members 1 and a plurality of positioning members 2, one retaining member 1 corresponding to one positioning member 2, the outflow end of the positioning member 2 being fixedly connected to the outflow end of the retaining member 1. In the present application, the connection between two or more components may be a direct connection between the components or an indirect connection between the components.

[0081] Referring to Figures 2(a), 2(b) and Figure 3 The inflow end of the positioning member 2 is a wave bar structure 2a in a compressed state and is located on the upper side of the inflow end of the retaining member 1. Referring to FIG. 1(a), the inflow end of the positioning member 2 extends to the outside of the retaining member 1 and crosses the inflow end of the retaining member 1 in an expanded state.

[0082] Since the inflow end of the positioning member 2 is a wave rod structure 2a in a compressed state, after it expands, the wave rod structure 2a opens to form a larger positioning member inflow end. The larger positioning member inflow end increases the contact area between the positioning member and the aortic valve sinus bottom, so that when the stent is subjected to a force in the direction of the ventricle, the positioning member inflow end can effectively disperse the force, thereby preventing the problem of aorta puncture caused by the sharpness of the positioning member inflow end. Since the positioning member 2 and the retaining member 1 need to cooperate to effectively capture the native leaflet, the inflow end of the positioning member cannot be closer to the inflow end of the stent than the inflow end of the retaining member, and the length from the inflow end of the positioning member to the inflow end of the stent cannot be too large, otherwise the stent will extend into the ventricular outflow tract in large quantities, resulting in a limited axial length of the anchoring portion, which limits the axial space of the anchoring portion structure. The anchoring portion requires a certain radial support force and compression performance to ensure that the anchoring portion can fit with the valve ring and that the stent can be smoothly delivered after compression. Now, through the wavy line structure 2a at the inflow end of the positioning member, the inflow end of the positioning member 2 can extend to cross the inflow end of the retaining member 1 after the stent is expanded. Therefore, while ensuring that the distance between the inflow end of the positioning member 2 and the inflow end of the stent does not increase, a larger axial space is created for the setting of the anchoring portion, and a better-performing anchoring portion structure can be set.

[0083] In this embodiment, refer to Figure 4 In order to reduce the damage caused by the impact of the inflow end of the positioning member on the aortic sinus bottom, the inflow end of the positioning member 2 is covered with a coating 3.

[0084] In this embodiment, the coating 3 is connected to the inflow end of the positioning member 2 through the suture line 31 during the coating process.

[0085] In this embodiment, the coating 3 is connected to the positioning rods 21 on both sides of the inflow end of the positioning member 2 through sutures 31. The sutures 31 do not fix the coating 3 through the wave bar structure 2a at the inflow end of the positioning member, and the coating 3 will not be torn during the straightening and bending of the wave bar structure 2a, thereby facilitating the bending deformation of the wave bar structure 2a.

[0086] In this embodiment, referring to FIG. 1( b ) and Figure 4 , a wire pull ring 5 is provided on the inner side of the inflow end of the positioning member 2, and the wire pull ring 5 is connected to the inflow end of the positioning member 2 through a connecting rod 51. The inner side of the inflow end of the positioning member 2 refers to the upper side of the positioning member 2. Since the positioning member 2 is a V-shaped structure as a whole, its concave side (i.e., the upper side) is its inner side. Obviously, the position of the wire pull ring 5 is as follows: Figure 1(a) to Figure 2(b) The through hole in the middle of the wire pull ring 5 can be regarded as a wire pull hole for passing the wire pull, and the wire pull is used to control the positioning member 2 to open a larger angle through the wire pull hole, so that the positioning member 2 can smoothly capture the native valve leaflet.

[0087] Reference Figure 4 The covering film 3 is respectively connected to the positioning rods 21 and the connecting rods 51 on both sides of the inflow end of the positioning member through sutures 31. In this way, the covering film 3 can be reliably fixed to the inflow end of the positioning member on both sides and the middle part without being fixed by the wave bar structure 2a.

[0088] In this embodiment, the specific structure of the wire pull ring 5 is not limited to the structure shown in Figure 1 (b) of the present invention. For example, a wire pull composite ring is provided on the inner side of the inflow end of the positioning member 2. The wire pull composite ring can be a wire pull ring 5 directly connected to the inflow end of the positioning member 2, or an opening is provided at the inflow end of the positioning member 2, and the lower part connected to the inflow end of the positioning member 2 is regarded as a connecting rod 51.

[0089] In this embodiment, refer to Figure 4 In order to prevent the coating 3 from sliding toward the inflow end of the positioning member, the middle part of the coating 3 is fixed by passing the suture thread 32 through the wire ring 5 to prevent the coating 3 from sliding axially.

[0090] In this embodiment, refer to Figure 5 In order to prevent the stent from wearing the coating 3, a polymer film 4 is provided inside the coating 3, that is, a polymer film 4 is provided between the coating 3 and the positioning member 2, so that a double-layer coating structure is formed at the inflow end of the positioning member 2. The double-layer coating structure effectively prevents the stent from wearing the coating 3, and also forms a double-layer coating structure by the coating 3 and the polymer film 4 to coat the inflow end of the positioning member, thereby increasing the elasticity at the inflow end of the positioning member and further reducing the damage of the inflow end of the positioning member to the aortic sinus bottom.

[0091] In this embodiment, the membrane 3 is animal tissue, and the animal tissue is preferably bovine pericardium or porcine pericardium.

[0092] In this embodiment, the material of the polymer film 4 is PET, ePTFE or FEP.

[0093] In this embodiment, in the expanded state, the axial distance from the inflow end of the positioning member 2 to the inflow end of the regurgitant valve stent does not exceed 15 mm, preferably 6 mm to 10 mm.

[0094] In this embodiment, referring to FIG. 2(a), FIG. 2(b) and Figure 3 In the compressed state, the middle part of the inflow end of the positioning member 2 is a bending structure, and there is at least another bending structure on both sides of the bending structure to form a wave rod structure 2a.

[0095] Specifically, Figure 3As shown, in the compressed state, the middle of the inflow end of the positioning member 2 is a bending structure of a U-shaped structure. When the inflow end of the positioning member 2 is provided with a pull ring 5 and a connecting rod 51, the inflow end of the connecting rod 51 is arranged on the upper side of the U-shaped structure, preferably in the middle of the upper side of the U-shaped structure. The two sides of the U-shaped structure each have a bending structure of an inverted U-shaped structure, so that a wave rod structure 2a with three bending structures is formed at the inflow end of the positioning member 2.

[0096] The number of bending structures of the wave rod structure 2a at the inflow end of the positioning member 2 can be determined according to the width of the inflow end of the retaining member 1 in the compressed state, so that in the compressed state, the inflow end of the positioning member 2 needs to be compressed and confined within the inflow end of the retaining member 1, so that when the regurgitant valve stent is transported, a single-layer stent is formed as a whole to reduce the radial diameter.

[0097] In this embodiment, in order to better enable the regurgitant valve stent to clamp the native leaflets, the positioning member 2 and the retaining member 1 have a cooperative shape, that is, in the expanded state, the shape of the positioning member 2 is roughly the same as that of the retaining member 1, and the native leaflets of the heart valve are clamped between the positioning member 2 and the retaining member 1. Since the shape of the positioning member 2 is roughly the same as that of the retaining member 1, the native leaflets can be firmly and effectively fixed.

[0098] In this embodiment, refer to Figure 9(a) to Figure 9(d) The inflow end of the retaining member 1 is a U-shaped structure, and a leak-proof membrane 11 is connected to the U-shaped structure of the retaining member 1.

[0099] Although the U-shaped structure of the inflow end of the retainer 1 can effectively prevent blood from flowing back, blood can still flow out from the U-shaped structure of the inflow end of the retainer 1 and pass through the gap between the anchoring portion 8 and the inner wall of the aorta to cause paravalvular leakage. In order to solve the problem of paravalvular leakage, the present application connects a leak-proof membrane 11 to the U-shaped structure of the inflow end of the retainer 1.

[0100] In this embodiment, referring to FIG. 9( b ), an inner leak-proof membrane 111 is provided inside the U-shaped structure at the inflow end of the retainer 1. It should be noted that the outflow end of the inner leak-proof membrane 111 generally does not exceed the U-shaped structure at the inflow end of the retainer 1. This is because the outflow end of the inner leak-proof membrane 111 is suspended without a fixed edge, and an excessively long outflow end edge of the inner leak-proof membrane 111 may cause its edge to fluctuate with the blood flow, causing the regurgitant valve stent to be unstable and to collide with the artificial valve leaflet multiple times.

[0101] In this embodiment, referring to FIG. 9( c ), an outer leak-proof membrane 112 is added to the outside of the U-shaped structure at the inflow end of the retainer 1. Such a design makes up for the shortcomings of the inner leak-proof membrane: when the artificial valve leaflet is opened, the outflow end of the inner leak-proof membrane 111 is too close to the artificial valve leaflet, and the inner leak-proof membrane 111 often rubs against the artificial valve leaflet, thereby causing damage to the artificial valve leaflet. Moreover, the inner leak-proof membrane 111 is located on the inner side of the stent and cannot fit tightly with the inner wall of the aorta. Blood can still pass through the gap between the inner leak-proof membrane 111 and the inner wall of the aorta to cause paravalvular leakage. The design of the outer leak-proof membrane 112 not only effectively prevents blood from passing through the U-shaped structure at the inflow end of the retainer 1 to cause paravalvular leakage, but also because the outer leak-proof membrane 112 fits tightly with the inner wall of the aorta, it can further prevent blood from leaking through the gap between the leak-proof membrane 11 and the inner wall of the aorta. At the same time, the design of the outer leak-proof membrane 112 being located on the outside of the stent can effectively avoid friction between the artificial valve leaflets and the outflow end of the outer leak-proof membrane 112, and to a great extent avoid possible damage to the artificial valve leaflets caused by the outer leak-proof membrane 112. Similarly, the outflow end of the outer leak-proof membrane 112 generally does not exceed the U-shaped structure of the inflow end of the retaining member 1. This is because the outflow end of the outer leak-proof membrane 112 is suspended without a fixed edge, and an excessively long edge of the outflow end of the outer leak-proof membrane 112 may cause its edge to fluctuate with the blood flow, causing instability in the regurgitant valve stent.

[0102] In the present embodiment, the regurgitant valve stent is only provided with an outer leak-proof membrane 112, or the regurgitant valve stent is only provided with an inner leak-proof membrane 111. In the present embodiment, the regurgitant valve stent can be provided with an outer leak-proof membrane 112 and an inner leak-proof membrane 111 at the same time. Furthermore, when the inner leak-proof membrane 111 and the outer leak-proof membrane 112 are provided at the same time, the outflow end of the inner leak-proof membrane 111 and the outer leak-proof membrane 112 can be connected, for example, by gluing, sewing, etc., thereby increasing the supporting force of the outflow end of the inner leak-proof membrane 111 and the outer leak-proof membrane 112, and reducing the fluctuation between the outflow ends of the inner leak-proof membrane 111 and the outer leak-proof membrane 112.

[0103] Embodiment 2:

[0104] 1(a) and 6(a), an embodiment of the present invention provides a regurgitant valve stent, comprising a plurality of retaining members 6 and a plurality of positioning members 7, wherein one retaining member 6 is provided with one positioning member 7, the outflow end of the positioning member 7 is fixedly connected to the outflow end of the retaining member 6, and the inflow end of the retaining member 6 is provided with an anchoring portion 8. A plurality of barbs 9 are provided on the circumference of the anchoring portion 8, and the free end 9a of the barb 9 is arranged opposite to the inflow end of the positioning member 7.

[0105] The inflow end of the positioning member 7 is designed to correspond to the barb 9, such as Figure 7As shown, the two clamp the aortic valve ring 10 at two relative positions in the axial direction, realizing a bidirectional fixed structure, and effectively realizing the purpose of better clamping the aortic valve ring 10 by the positioning member 7 and the barb 9. Compared with clamping the aortic valve leaflets, the leaflets can shake, and the position of the leaflets is not unique, so the stent can still shake with the shaking of the leaflets, while the position of the valve ring is stable and will not shake, so the present invention uses the cooperation of the positioning member 7 and the barb 9 to clamp the aortic valve ring 10, and realizes the firm fixation of the stent. Secondly, it is clinically found that in the case of the aortic valve leaflets (normally three-leaflet valves) with two-leaflet valves, four-leaflet valves or abnormal valves, the positioning member 7 may need to be inserted obliquely into the aortic sinus. At this time, the leaflets are not conducive to clamping, and the cooperation of the positioning member 7 and the barb 9 can also realize the firm fixation of the stent in the case of two-leaflet valves, four-leaflet valves or abnormal valves.

[0106] In this embodiment, referring to FIG. 1( b ), in the expanded state, the axial distance between the inflow end of the positioning member 7 and the free end 9 a of the barb 9 is H, wherein 1 mm ≤ H ≤ 6 mm, preferably 2 mm ≤ H ≤ 4 mm.

[0107] In this embodiment, the length of the barb 9 is not less than 1.0 mm, and preferably not less than 2 mm, thereby achieving stable embedding of the barb 9 and effectively clamping the aortic valve ring 10 through the positioning piece 7 and the barb 9.

[0108] In the stent, the middle width of the barb is greater than the width of the outflow end of the barb. Generally, the middle width of the barb is equal to or less than the width of the inflow end of the barb. In the present embodiment, another structure of the barb is provided, and the middle width of the barb 9 is greater than the width of both ends of the barb, that is, the inflow end of the barb is narrower. Firstly, the space occupied by the barb 9 on the anchoring portion can be reduced, and the internal stress generated at the connection between the barb 9 and the anchoring portion 8 during the compression process can be reduced. Secondly, the barb 9 can be made more flexible, and the narrow width of the outflow end is conducive to the insertion of the barb into the valve ring, while the larger width of the middle portion can make the barb better riveted into the human tissue. It should be stated here that any form of the above-mentioned barb structure can be used as the barb 9 of the present application.

[0109] In this embodiment, the inflow end of the barb 9 is connected to the anchoring portion 8 as the fixed end 9 b , and the outflow end of the barb 9 is arranged opposite to the inflow end of the positioning member 7 as the free end 9 a .

[0110] In this embodiment, the fixed end 9b of the barb 9 is inclined outward, and the free end 9a of the barb 9 is inclined inward relative to the fixed end 9b to remain parallel to the axis of the regurgitant valve stent.

[0111] As shown in FIG. 6( a ), the axis of the regurgitant valve stent is axis A, the axis of the free end 9 a of the barb 9 is axis B, and axis B is parallel to axis A.

[0112] The barbs 9 are structured to first tilt outwards and then tilt inwards from the inflow end to the outflow end until they remain parallel to the axis of the regurgitant valve stent, which has the following advantages:

[0113] When blood passes through the stent, it will cause the stent to shake. At this time, the barbs 9 that are only inclined outwards can hardly provide a circumferential riveting force to the stent. Therefore, the barbs 9 that are only inclined outwards may be pulled out, and then repeatedly inserted into human tissue, causing damage to the aortic valve ring. After the barbs 9 that are inclined inwards are inserted into human tissue, their free ends 9a remain parallel to the axis of the stent, so they can provide a circumferential riveting force for the stent, so that the aortic valve ring and the anchoring portion 8 can be effectively fitted, which not only prevents the circumferential shaking of the stent, but also reduces the paravalvular leakage between the aortic valve ring and the anchoring portion 8.

[0114] If the barbs 9 that are only tilted outward cannot be fully inserted into the human tissue, when the stent is subjected to an axial force, the barbs 9 are easy to scratch and tear the human tissue. However, the barbs 9 with free ends 9a that are relatively tilted inward will not scratch and tear the human tissue because the free ends 9a are basically parallel to the axis of the stent. Moreover, when the stent is subjected to a force away from the ventricle, the barbs 9 can be inserted deeper into the human tissue, and the stent can be fixed more securely. On the contrary, when the stent is subjected to a force toward the ventricle, due to the limitation of the positioning member 7, the stent will not move toward the ventricle in large quantities. Since the free ends 9a of the barbs 9 are parallel to the axis of the stent, the sliding of the barbs 9 at this time will not completely separate the barbs 9 from the inserted human tissue, so the barbs 9 will not be repeatedly pulled out and then inserted into the human body.

[0115] Since the anchoring portion 8 needs to be compressed and placed in the loading chamber, and the barb 9 which is only inclined outward has its free end 9a always facing outward and pointing to the outflow end, when the loading chamber moves toward the inflow end relative to the stent, the relatively sharp free end 9a of the barb 9 is very easy to be inserted into the loading chamber, causing the loading chamber to be unable to move smoothly, making it impossible to release the anchoring portion 8 of the stent, and further causing difficulty in or even failure to release the stent, seriously threatening the life and health of the implantee. In the present invention, the barb 9 with the free end 9a inclined inward can be retracted so that the free end 9a of the barb 9 points to the stent, and the middle part of the barb 9 contacts the loading chamber. At this time, the free end 9a of the barb 9 will not contact the loading chamber, thereby will not affect the axial movement of the loading chamber, which is conducive to the smooth release of the anchoring portion 8.

[0116] In this embodiment, the fixed end 9b of the barb 9 is inclined outward by 7° to 15°, for example, 9°, 11°, 12°, 14°, etc.

[0117] In this embodiment, referring to FIG. 1( b ), a wire pull ring 5 is provided on the inner side of the inflow end of the positioning member 2, and the wire pull ring 5 is connected to the inflow end of the positioning member 2 via a connecting rod 51. The inner side of the inflow end of the positioning member 2 refers to the upper side of the positioning member 2. Since the positioning member 2 is a V-shaped structure as a whole, its concave side (i.e., the upper side) is its inner side. Obviously, the position of the wire pull ring 5 is as follows: Figure 1(a) to Figure 2(b) It is also clearly indicated. The through hole in the middle of the pull wire ring 5 can be regarded as a pull wire hole for passing the pull wire. The pull wire is used to control the positioning member 2 to open a larger angle through the pull wire hole, so that the positioning member 2 can successfully capture the native valve leaflet. When the stent 1000 (i.e., the regurgitant valve stent of the present invention) is implanted, as shown in Figure 11 (a), the positioning member 2 is generally inserted into the aortic sinus first, and then the anchoring portion 8 is released as shown in Figure 11 (b). At this time, the position of the barb 9 is confirmed, but due to the curved design of the barb 9, after the anchoring portion 8 expands, the barb 9 cannot immediately penetrate into the human tissue / aortic valve ring. The anchoring portion 8 needs to move toward the outflow end to allow the barb 9 to penetrate into the human tissue. However, if the stent 1000 is pulled directly toward the outflow end (away from the ventricle), although the barb 9 will be inserted into the aortic valve ring, it will also drive the positioning member 2 to move backward toward the outflow end, and then the positioning member 2 cannot be against the bottom of the aortic sinus. When the stent is subjected to blood pressure toward the inflow end (towards the ventricle), due to If the positioning member 2 is not firmly against the aortic valve ring, the stent will move toward the ventricle, which will increase the risk of the barb 9 coming out of the human tissue, thereby causing the stent to be unreliably fixed. As shown in Figure 11(c), the positioning member can now be controlled to open at a certain angle by a pull line. During the opening of the positioning member, the inflow end of the positioning member 2 will leave the bottom of the aortic sinus. At this time, the stent 1000 can be moved to continue to move toward the ventricle. After moving a certain distance, the stent 1000 is pulled away from the ventricle so that the barb 9 is inserted into the human tissue. At this time, the pulled positioning member 2 is lowered by the pull line, and the inflow end of the positioning member 2 is against the bottom of the aortic sinus, and the barb 9 also penetrates into the human tissue, so that the positioning member 2 and the barb 9 form a good shape for clamping the aortic valve ring, achieving a better clamping effect, that is, by repeatedly opening the positioning member 2, the stent can be moved toward the ventricle, so that the insertion position of the barb 9 can be controlled, and the aortic valve ring can be accurately clamped in cooperation with the positioning member 2.

[0118] In this embodiment, refer to Figure 8(a) to Figure 8(c) The number of groups of barbs 9 is consistent with the number of positioning members 7. A group of barbs 9 may include 1, 2, or 3 barbs 9, which correspond to each other and clamp the valve ring. Moreover, the barbs 9 are preferably evenly distributed along the circumference of the regurgitant valve stent to ensure balanced stress of the stent. As shown in FIG8(b), a group of barbs 9 includes 3 barbs 9, wherein a barb 9 in the middle is arranged corresponding to the inflow end of the positioning member 7.

[0119] In this embodiment, the fixed end 9b of the barb 9 is tilted outward to the middle position and then tilted inward to the free end 9a of the barb 9. The barb 9 is bounded by the middle position, the inflow end side at the middle position is an outward tilted structure, and the outflow end side at the middle position is an inward tilted structure.

[0120] In this embodiment, the inflow end of the barb 9 is connected to the inflow end of the anchoring portion 8 .

[0121] In this embodiment, the axial distance from the inflow end of the positioning member 7 to the inflow end of the regurgitant valve stent does not exceed 15 mm, preferably 6 mm to 10 mm, to prevent the stent from extending excessively into the ventricular outflow tract.

[0122] Because the distance from the positioning member 7 to the inflow end of the stent is limited, in this embodiment, the outer diameter of the middle portion of the anchoring portion 8 is larger than the outer diameter of the outflow end of the anchoring portion 8 and the outer diameter of the inflow end of the anchoring portion 8, so that the anchoring portion 8 forms a middle outward expansion structure.

[0123] As shown in FIG. 10( a ), the outer diameter of the outflow end of the anchoring portion 8 is D1 , the outer diameter of the middle portion of the anchoring portion 8 is D2 , and the outer diameter of the inflow end of the anchoring portion 8 is D3 , then, D2>D1 and D2>D3 .

[0124] After the above design, the middle part of the anchoring portion 8 is expanded outward relative to the outflow end, which is conducive to the anchoring portion 8 being stably stuck in the valve ring and maintaining the stability of the stent, while the inflow end of the anchoring portion 8 is contracted relative to the middle part to prevent its inflow end from touching the ventricular outflow tract wall and prevent its inflow end from accidentally touching the His bundle, so that a relatively longer anchoring portion can be set.

[0125] In this embodiment, the anchoring portion 8 is formed by connecting a plurality of rhombus-shaped grids in a circumferential direction, thereby maintaining the compressibility of the anchoring portion 8. In other embodiments, the anchoring portion 8 may also be a fold line structure or other compressible and expandable structures.

[0126] In this embodiment, the anchoring portion 8 is formed by circumferentially connecting a number of diamond-shaped grids with expanded middle portions. In order to allow the barb 9 to be smoothly inserted into the valve ring, referring to FIG. 10( a ), the inflow end of the barb 9 can be arranged at the connection between adjacent diamond-shaped grids, keeping the inflow end of the barb 9 at the maximum outer diameter of the anchoring portion 8, so that the barb 9 can fully contact the aortic valve ring for riveting.

[0127] In this embodiment, the axial middle portions of a plurality of diamond-shaped grids expand outward to form a middle-portion outward expansion structure.

[0128] It can be considered that the circumferential connection point of several diamond-shaped grids is the axial middle part, which expands outward to form a middle-outward expansion structure.

[0129] In this embodiment, the number of diamond grids is n, and 12≤n≤27.

[0130] In this embodiment, referring to FIG. 10( a ), when the diamond grid is in an expanded state, the distance from the outflow end of the diamond grid to the connection between adjacent diamond grids is X, and the circumferential length of the diamond grid is Y.

[0131] This is because the diameter of the aortic valve ring is generally 20mm to 30mm, and the diameter of the aortic valve of patients with valve ring dilatation increases by 1mm to 5mm, and some patients increase by 8mm or even more. The diameter of the regurgitant valve stent is generally set corresponding to the diameter of the aortic valve ring (according to the size of the aortic valve ring with lesions), so the diameter of the product can also be multiple, such as TARV 23 (the outer contour diameter of the outflow end of the anchoring part of the regurgitant valve stent is 23mm), TARV 31 (the outer contour diameter of the outflow end of the anchoring part of the regurgitant valve stent is 31mm), etc. In the case where the number of diamond grids remains unchanged, if the anchoring part 8 surrounded by too slender diamond grids is set, its radial support force is relatively small, and the deformation of too short diamond grids is difficult, which is easy to produce stress concentration, which is not conducive to the compression of the stent, or the too short diamond grid has poor resilience, and the compressed stent is difficult to return to the initial diameter after self-expansion.

[0132] The present invention can ensure that the prismatic grid of the anchoring portion 8 has a sufficiently long length X through the outward expansion structure design of the middle part of the anchoring portion 8, and can set a more reasonable prismatic grid of 2X / Y under the condition that the circumference of the inflow end of the regurgitant valve stent remains unchanged and the number of diamond grids remains unchanged.

[0133] The length X of the diamond grid and the circumferential length Y of the diamond grid mentioned in the present invention are both the lengths of the regurgitant valve stent in the expanded state.

[0134] In this embodiment, referring to FIG. 10( a ), the inflow end of the anchoring portion 8 is a retracted structure retracted inwardly relative to the middle portion of the anchoring portion 8 , and the retracted angle of the inflow end of the anchoring portion 8 is α, then 15°≤α≤45°.

[0135] If the retraction angle α is too small, the retraction effect of the inflow end of the anchoring portion 8 is not obvious, and the possibility of the inflow end of the anchoring portion 8 touching the ventricular outflow tract is still very high. If the retraction angle α is too large, the anchoring portion 8 with the membrane will block the blood flow through the ventricular outflow tract, which will increase the resistance (and also reduce the effective opening area of ​​the valve) and will be unfavorable to the endothelialization of the anchoring portion 8. The present invention avoids the above problems by limiting the retraction angle α.

[0136] In this embodiment, the retraction angle of the inflow end of the anchoring portion 8 is α, and 32°≤α≤36°. With such a limitation, not only the inflow end of the anchoring portion 8 is not easy to touch the ventricular outflow tract, but also the retracted inflow end of the anchoring portion will not cause a large resistance to the circulation of blood, and is conducive to the endothelialization of the inflow end of the regurgitant valve stent.

[0137] In this embodiment, a coating is only provided between the middle of the anchoring portion 8 and the outflow end of the anchoring portion 8, while no coating is provided between the middle of the anchoring portion 8 and the inflow end of the anchoring portion 8. No coating is provided from the middle to the inflow end, and the inflow end of the anchoring portion without coating is not prone to endothelialization of the stent, that is, the exposed metal rod is not prone to endothelialization by human tissue attachment, so that blood can flow through the gaps of the diamond grid without forming human tissue protruding relative to the surface of the ventricular outflow tract, which can prevent the gathered inflow end of the anchoring portion from generating greater resistance to the blood, and is conducive to the smooth passage of blood through the ventricular outflow tract.

[0138] In this embodiment, referring to FIG9( d ), when the regurgitant valve stent is provided with the anti-leakage membrane 11 , the covering membrane 81 of the anchoring portion 8 is connected to the anti-leakage membrane 11 . At this time, the barbs 9 extend out of the covering membrane 81 .

[0139] When the coating 81 of the anchoring portion 8 is located on the inner side of the regurgitant valve stent, the coating 81 of the anchoring portion 8 is connected to the inner anti-leakage membrane 111 .

[0140] When the coating 81 of the anchoring portion 8 is located outside the regurgitant valve stent, the coating 81 of the anchoring portion 8 is connected to the outer anti-leakage membrane 112 .

[0141] In this embodiment, referring to FIG. 10( b ) and FIG. 10 ( c ), a coating 100 covering the retaining member 6 to the middle of the anchoring portion 8 is provided on the inner side of the regurgitant valve stent.

[0142] 10 (b), if the U-shaped structure of the retaining member 6 is provided with an inner anti-leakage membrane 111, the coating 100 is connected to the inner anti-leakage membrane 111, or the inner anti-leakage membrane 111 is not provided, and the coating 100 covers the U-shaped structure of the retaining member 6.

[0143] 10( c ), if an outer anti-leakage film 112 is provided at the U-shaped structure of the retainer 6 , the coating 100 is connected to the inner anti-leakage film 111 .

[0144] In this embodiment, the covering film is connected to the inner anti-leakage film by sewing, gluing or integrally forming.

[0145] In this embodiment, the inflow end of the retaining member 6 is fixedly connected to the anchoring portion 8 to form a relatively stable structure.

[0146] In this embodiment, the retaining member 6 in this embodiment adopts the retaining member 1 in each embodiment of Embodiment 1, which will not be described in detail here.

[0147] In this embodiment, the positioning member 7 in this embodiment adopts the positioning member 2 in each embodiment of Embodiment 1, which will not be described in detail here.

[0148] In this embodiment, referring to FIG. 12( a ), when the stent 1000 is implanted in the heart, the stent 1000 and the delivery system 2000 are placed in the sheath system 400 and then enter the heart through the sheath system 400. During the delivery process, the stent 1000 in the sheath system 400 is in a compressed state. The distal end 300 of the delivery system (in this embodiment, "distal end" refers to the side of the delivery system that is away from the end operated by the user) includes an ear-hanging sheathing tube 301, and a middle conduit 304 is arranged inside the ear-hanging sheathing tube 301. The distal end of the middle conduit 304 is provided with a groove 30401 that matches the connecting portion 500 of the bracket 1000. The circumferential width of the outflow end of the connecting portion 500 is greater than the circumferential width of the connecting web 501, and the groove 30401 that matches the distal end shape of the middle conduit 304 corresponds to the circumferential width of the connecting web 501. The distal end size of the groove 30401 can pass through the connecting web 501 but cannot pass through the connecting block 502, so that the connecting portion 500 of the bracket 1000 can be stably confined in the groove 30401 in the axial direction, as shown in Figure 12(b). The ear-hanging covering tube 301 surrounds the middle conduit 304, so that the connecting portion 500 of the stent 1000 cannot pop out from the groove 30401, and the outflow end of the stent 1000 is also in a compressed state. The inner conduit 302 is arranged inside the middle conduit 304, and the inner conduit 302 passes through the inside of the stent 1000, and the sleeve 303 is connected to the distal end of the inner conduit 302. The sleeve 303 is arranged outside the distal end of the inner conduit 302, and a gap for installing the stent 1000 is left between the sleeve 303 and the inner conduit 302. It should be noted that, as shown in FIG. 12(a), only the anchoring portion 8 of the stent 1000 is folded in the gap between the sleeve 303 and the inner conduit 302, and the positioning member 2 is folded by the sheath system 400 to ensure that the inflow end of the stent 1000 is in a compressed state and finally transported in a compressed state.

[0149] When the stent 1000 reaches the designated position, the stent 1000 is released. The sheath system 400 is withdrawn first. It should be noted that since the inner wall of the sheath system 400 is smooth and the distal end of the positioning member 2 is also flat, the sliding conveying operation can be completed smoothly. During the withdrawal of the sheath system 400, the positioning member 2 gradually extends. When the sheath system 400 retreats a certain distance, the positioning member 2 will lose its circumferential restraining force and thus bounce outward, forming a state as shown in Figure 11 (a), which can then be used to capture the native aortic valve leaflets.

[0150] Generally, after the positioning member 2 is inserted into the aortic sinus, the inner catheter 302 is used to push the sleeve 303 forward, as shown in Figure 11(b), so that the anchoring portion 8 is released from the gap between the sleeve 303 and the inner catheter 302. At this time, the position of the barb 9 is confirmed, but due to the curved design of the barb 9, after the anchoring portion 8 expands, the barb 9 cannot immediately penetrate into the human tissue / aortic valve ring. The anchoring portion 8 needs to move toward the outflow end to allow the barb 9 to penetrate into the human tissue. However, if the stent 1000 is pulled directly toward the outflow end (away from the ventricle), although the barb 9 will be inserted into the aortic valve ring, it will also drive the positioning member 2 to move backward toward the outflow end, and then the positioning member 2 cannot be against the bottom of the aortic sinus. When the stent is subjected to blood pressure toward the inflow end (towards the ventricle), since the positioning member 2 is not firmly against the aortic valve ring, the stent will move toward the ventricle, which will increase the risk of the barb 9 coming out of the human tissue, thereby causing the stent to be unreliably fixed. As shown in Figure 11(c), the barb 9 adjustment step is performed at this time: the positioning piece can be controlled to open a certain angle by pulling the wire. During the process of opening the positioning piece, the inflow end of the positioning piece 2 will leave the bottom of the aortic sinus. At this time, the stent 1000 can be moved to continue to move toward the ventricle. After moving a certain distance, the stent 1000 is pulled away from the ventricle to allow the barb 9 to insert into the human tissue. At this time, the pulled positioning piece 2 is lowered by pulling the wire again, and the inflow end of the positioning piece 2 is against the bottom of the aortic sinus, and the barb 9 also penetrates into the human tissue, so that the positioning piece 2 and the barb 9 form a good shape for clamping the aortic valve ring, achieving a better clamping effect, that is, by repeatedly opening the positioning piece 2, the stent 1000 can be moved toward the ventricle, so that the insertion position of the barb 9 can be controlled, and the aortic valve ring can be accurately clamped in cooperation with the positioning piece 2.

[0151] Next, the ear-hanging covering tube 301 is retracted, so that the connection portion 500 of the stent 1000 loses the circumferential restraining force and pops out from the groove 30401. At this time, the outflow end of the stent 1000 is separated from the distal end 300 of the delivery system, and the entire stent 1000 is released, that is, the state shown in Figure 12 (c). After that, the delivery system 2000 is withdrawn from the human body, and the stent 1000 will remain stably in the heart.

[0152] In some embodiments, reference Fig.13, the stent 1000 is in a compressed state during the delivery process of the delivery system. Similar to FIG. 12( b), the distal end 300 of the delivery system includes a hook wrap tube 301, and a middle conduit 304 is arranged inside the hook wrap tube 301. The distal end of the middle conduit 304 is provided with a groove 30401 matching the connecting portion 500 of the stent 1000. The circumferential width of the outflow end of the connecting portion 500 is greater than the circumferential width of the connecting web 501, and the groove 30401 corresponding to the distal end shape of the middle conduit 304 matches the distal end shape of the middle conduit 304. The distal end size of the groove 30401 can pass through the connecting web 501 but cannot pass through the connecting block 502, so that the connecting portion 500 of the stent 1000 can be stably confined in the groove 30401 in the axial direction, and the hook wrap tube 301 surrounds the middle conduit 304, so that the stent 1 000's connecting portion 500 cannot pop out from the groove 30401, and at the same time, the outflow end of the stent 1000 is also in a compressed state. An inner catheter 302 is arranged inside the middle catheter 304, and the inner catheter 302 passes through the interior of the stent 1000. The distal end of the inner catheter 302 is connected to the sleeve 303, and the sleeve 303 is arranged on the outside of the distal end of the inner catheter 302. A gap for installing the stent 1000 is left between the sleeve 303 and the inner catheter 302. It should be noted that the sleeve 303 gathers the inflow end of the stent 1000, including the inflow end of the positioning member 2 and the anchoring portion 8, inside the sleeve 303, that is, in the gap between the sleeve 303 and the inner catheter 302, thereby keeping the inflow end of the stent 1000 in a compressed state, and finally transporting the stent 1000 in a compressed state.

[0153] When releasing the stent 1000, the inner catheter 302 and the sleeve 303 are pushed forward to release the positioning member 2 from the sleeve 303. Of course, by pulling back the ear-covering tube 301 and the middle catheter 304 together, the stent 1000 is driven to move backward to release the positioning member 2 from the sleeve 303. Alternatively, the positioning member 2 can be aligned with the native aortic leaflet, and the ear-covering tube 301 and the middle catheter 304 (or the ear-covering tube 301, the middle catheter 304 and the inner catheter 302) are pushed forward to capture the native leaflet, that is, the positioning member 2 is inserted into the aortic sinus, and the inner catheter 302 and the sleeve 303 are pushed forward again to completely release the inflow end of the stent 1000, that is, the inflow end of the stent 1000 is completely released from the sleeve 303. Then, the step of adjusting the barb 9 is performed. Thereafter, the ear hook covering tube 301 is pulled back or the middle catheter 304 is pushed forward, so that the connecting portion 500 of the stent 1000 or the groove 30401 of the middle catheter 304 is out of the coverage of the ear hook covering tube 301. At this time, the connecting portion 500 of the outflow end of the stent 1000 has no radial expansion resistance. Under the expansion action of the stent 1000, the connecting portion 500 pops out of the groove 30401, so that the outflow end of the stent 1000 is out of the distal end 300 of the delivery system, thereby completing the complete release of the entire stent 1000. After that, the delivery system is withdrawn from the human body, and the stent 1000 will remain stably in the heart.

[0154] The present invention is described in detail above in conjunction with the embodiments of the accompanying drawings. A person skilled in the art can make various variations of the present invention according to the above description. Therefore, some details in the embodiments should not be construed as limiting the present invention, and the present invention shall be protected by the scope defined by the attached claims.

Claims

1. A regurgitant valve stent, comprising a plurality of retaining members and a plurality of positioning members, wherein one retaining member is provided with a corresponding positioning member, an outflow end of the positioning member is fixedly connected to an outflow end of the retaining member, and an inflow end of the retaining member is provided with the anchoring portion; It is characterized in that A plurality of barbs are arranged on the circumference of the anchoring portion, and the free ends of the barbs are arranged opposite to the inflow end of the positioning member.

2. The regurgitant valve stent according to claim 1, characterized in that: The axial distance between the inflow end of the positioning member and the free end of the barb is H, wherein 1 mm ≤ H ≤ 6 mm, preferably 2 mm ≤ H ≤ 4 mm; and / or, the length of the barb is not less than 1.0 mm, and the length of the barb is preferably not less than 2 mm; And / or, the axial distance from the inflow end of the positioning member to the inflow end of the regurgitant valve stent does not exceed 15 mm, preferably 6 mm to 10 mm.

3. The regurgitant valve stent according to claim 1, characterized in that: The width of the middle portion of the barb is greater than the width of the two ends of the barb.

4. The regurgitant valve stent according to claim 1, characterized in that: The inflow end of the barb is connected to the anchoring portion as a fixed end, and the outflow end of the barb is arranged opposite to the inflow end of the positioning member as a free end; The fixed end of the barb is inclined outward, and the free end of the barb is inclined inward relative to the fixed end to remain parallel to the axis of the regurgitant valve stent.

5. The regurgitant valve stent according to claim 4, characterized in that: The fixed end of the barb is inclined outward by 7° to 15°.

6. The regurgitant valve stent according to claim 4, characterized in that: The fixed end of the barb tilts outward to a middle position and then tilts inward to a free end of the barb.

7. The regurgitant valve stent according to claim 1, characterized in that: The number of groups of the barbs is consistent with the number of the positioning elements; A group of the barbs comprises a plurality of barbs, and a free end of at least one barb in the same group is arranged opposite to the inflow end of the positioning member.

8. The regurgitant valve stent according to claim 1, characterized in that: The outer diameter of the middle portion of the anchoring portion is larger than the outer diameter of the outflow end of the anchoring portion and the outer diameter of the inflow end of the anchoring portion, so that the anchoring portion forms a middle outward expansion structure; The inflow end of the barb is arranged as a fixed end at the middle outward expansion structure of the anchoring part.

9. The regurgitant valve stent according to claim 8, characterized in that: The anchoring portion is formed by connecting a plurality of diamond-shaped grids with the middle portion expanding outwards in a circumferential direction; The inflow end of the barb is arranged at the connection of two adjacent diamond-shaped grids.

10. The regurgitant valve stent according to any one of claims 1 to 9, characterized in that: The inflow end of the positioning member is a wave rod structure in a compressed state and is located on the upper side of the inflow end of the retaining member; The inflow end of the positioning member extends to the outside of the retaining member and crosses the inflow end of the retaining member in an expanded state.

11. The regurgitant valve stent according to claim 10, characterized in that: The inflow end of the positioning piece is covered with a positioning piece coating.

12. The regurgitant valve stent according to claim 11, characterized in that: The covering film is respectively connected to the positioning rods on both sides of the inflow end of the positioning member through sutures; Alternatively, a wire draw ring is provided on the inner side of the inflow end of the positioning member, and the wire draw ring is connected to the inflow end of the positioning member via a connecting rod; the covering film is respectively connected to the positioning rods on both sides of the inflow end of the positioning member and the connecting rod via sutures.

13. The regurgitant valve stent according to claim 12, characterized in that: The middle part of the covering membrane is fixed by passing a suture through the drawstring ring.

14. The regurgitant valve stent according to claim 11, characterized in that: A polymer film is arranged between the coating and the positioning member, so that a double-layer coating structure is formed at the inflow end of the positioning member.

15. The regurgitant valve stent according to claim 14, characterized in that: The covering membrane is animal tissue, and the animal tissue is preferably bovine pericardium or porcine pericardium; The material of the polymer film is preferably PET, ePTFE or FEP.

16. The regurgitant valve stent according to claim 1, characterized in that: The barbs are adjusted in the following manner: After the regurgitant valve stent releases the anchoring portion through a delivery system and the anchoring portion expands, the positioning member is controlled to open to a preset angle by a pull wire, and the pull wire is connected to a pull wire ring provided on the inner side of the inflow end of the positioning member; The regurgitant valve stent is moved toward the inflow end by the delivery system, and after being moved to a preset distance, the regurgitant valve stent is pulled toward the outflow end by the delivery system so that the barb is inserted into the first target position; The positioning member is lowered and pulled up by the pull line, and the inflow end of the positioning member abuts against the second target position, so that the positioning member and the corresponding barb form a bidirectional fixed structure.

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