Regurgitant valve stent

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to a regurgitant valve stent. A regurgitant valve stent comprises a plurality of retaining members and a plurality of positioning members, wherein a positioning member is provided corresponding to one retaining 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 an anchoring portion; a plurality of barbs are provided 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. The design of the corresponding arrangement of the inflow end of the positioning member of the present invention and the barbs clamp the aortic valve ring at two relative positions in the axial direction, thereby realizing a bidirectional fixed structure and effectively achieving the purpose of better clamping the aortic valve ring through the positioning member and the barbs.

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 to 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 "Aortic regurgitation valve stent with a bendable positioning member" (publication number: CN115624416A) provides an aortic regurgitation valve stent, which mainly relies on the anchoring part to engage the aortic valve ring to limit the valve movement away from the ventricle, and 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 aforementioned 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 the 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 spans the inflow end of the retaining member in an expanded state.

[0008] Optionally, in the aforementioned regurgitant valve stent, 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 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 pull wire ring is provided on the inner side of the inflow end of the positioning member, and the pull wire 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 piece and the connecting rod through sutures.

[0012] Optionally, in the aforementioned regurgitant valve stent, the middle portion of the membrane is fixed by passing a suture through the pull wire ring.

[0013] Optionally, in the aforementioned regurgitant valve stent, a polymer film is provided between the covering membrane and the positioning member, so that a double-layer covering 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 aforementioned regurgitant valve stent, 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 aforementioned 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 provided 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 serves as a fixed end connected to the anchor portion, and the outflow end of the barb serves as a free end and is disposed opposite to the inflow end of the positioning member.

[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 aforementioned regurgitant valve stent, 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 central 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 progress effect of the present invention is:

[0034] 1. The inflow end of the positioning piece is a wave-rod structure in the compressed state, and in the expanded state after expansion, the wave-rod 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, 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 into the ventricular outflow tract in large quantities, resulting in limited axial length of the anchoring portion, which limits the space of the anchoring portion structure. The wavy line structure of 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 covered with a film.

[0037] The covering of the membrane 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 covering 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 covering film from sliding toward the inflow end of the positioning member, the middle part of the covering film is fixed by passing a suture thread through a drawstring ring, thereby preventing the covering film 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. In addition, a double-layer coating structure is formed by the coating and the polymer film 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 bottom of the aortic sinus.

[0040] 3. The inflow end of the positioning piece and the barbs are designed to correspond to each other, and the two clamp the aortic valve ring at two relative positions in the axial direction, realizing a bidirectional fixed structure, and effectively achieving the purpose of better clamping the aortic valve ring through 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. Therefore, the present invention uses the cooperation of the positioning piece and the barbs to clamp the aortic valve ring, thereby achieving a firm fixation of the stent. Secondly, it is clinically found that in the case of aortic valve leaflets (normally tricuspid valves) with bicuspid valves, quadcuspid 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 achieve a firm fixation of the stent in the case of bicuspid valves, quadcuspid valves or deformed valves.

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

[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, so that the aortic valve ring and the anchoring part can be effectively fitted, 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 the human tissue, the barbs will easily scratch and tear the human tissue when the stent is subjected to axial force. However, the barbs with relatively inward-tilted free ends will not scratch or tear the 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 penetrate deeper into the human tissue and 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, the stent will not move significantly in the direction of the ventricle due to the limitation of the positioning member. 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 reinserted into the human body.

[0044] Since the anchoring portion needs to be compressed and placed into the loading chamber, and the barbs that are only tilted 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 insert 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 making it difficult or even impossible 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 tilted inward can be retracted so that the free ends of the barbs point to the stent, and the middle parts of the barbs contact the loading chamber. At this time, the free ends of the barbs will not contact the loading chamber, and will not affect the axial movement of the loading chamber, which is conducive 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 for illustrative purposes only and are not intended to limit the scope of protection of the present invention. In the drawings:

[0046] FIG1( a ) is a schematic structural diagram of a regurgitant valve stent in an expanded state according to an embodiment of the present invention;

[0047] Figure 1(b) is a partial enlarged view of Figure 1(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] Figure 2(b) is a front view of Figure 2(a);

[0050] Figure 2(c) is a partial enlarged view of Figure 2(a);

[0051] Figure 3 This is a schematic diagram of a deployed 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 film;

[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 structural diagram of the regurgitant valve stent in an expanded state according to an embodiment of the present invention;

[0055] Figure 6(b) is a partial enlarged view of Figure 6(a);

[0056] Figure 7 This is a schematic diagram of an application of an embodiment of the present invention;

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

[0058] Figure 8(b) is a partial enlarged view of Figure 8(a);

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

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

[0061] FIG9( b ) is a schematic diagram of a structure in which an inner leak-proof membrane is added to the inner side of 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 anchor portion in an embodiment of the present invention;

[0064] FIG10( a ) is another schematic structural diagram of a 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 membrane 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] FIG11( a ) is a schematic diagram of a positioning member of a regurgitant valve stent according to an embodiment of the present invention aligned with a native aortic valve leaflet and inserted into the aortic sinus;

[0068] FIG11( b ) is a schematic diagram of the regurgitant valve stent after the anchoring portion is released and expanded according to 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, with the positioning member opened at a certain angle;

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

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

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

[0073] Figure 13 Schematic diagram of the structure 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. Those skilled in the art will readily understand the other advantages and benefits of the present invention from the disclosure herein. The present invention may also be implemented or applied through various other specific embodiments, and the details in this specification may be modified or altered based on different perspectives and applications without departing from the spirit of the present invention.

[0075] It should be noted that, unless there is any conflict, the following embodiments and features therein may be combined with each other.

[0076] In the description of the present invention, it should be noted that, for directional words, such as the terms "outside", "middle", "inside", "outside", etc., the directions and positional relationships indicated are based on the directions or positional relationships shown in the accompanying 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 scope of protection of the present invention.

[0077] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features. Therefore, the terms "first" and "second" may explicitly or implicitly refer to one or more of these features. Throughout the description of the present invention, "several" and "a number" mean two or more, unless otherwise 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 when it is 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 when it is 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 it is 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] Example 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, wherein one retaining member 1 corresponds to one positioning member 2, and the outflow end of the positioning member 2 is 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 Figure 2(a), Figure 2(b) and Figure 3 The inflow end of the positioning member 2 in the compressed state is a wave-bar structure 2a and is located above the inflow end of the retaining member 1. Referring to Figure 1(a), the inflow end of the positioning member 2 in the expanded state extends to the outside of the retaining member 1 and crosses the inflow end of the retaining member 1.

[0082] Because the inflow end of the positioning member 2 is a wave-bar structure 2a in its compressed state, it expands after expansion, forming a larger inflow end. This larger inflow end increases the contact area between the positioning member and the aortic valve sinus floor, effectively dispersing the force applied to the stent toward the ventricle, thus preventing the aorta from being punctured by the sharp 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 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 be extended 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, referring to Figure 4 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 2 is covered with a membrane 3.

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

[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 via sutures 31. The sutures 31 do not secure the coating 3 through the wave-shaped bar structure 2a at the inflow end of the positioning member. Therefore, the coating 3 is not torn during the straightening and bending of the wave-shaped bar structure 2a, thereby facilitating the bending deformation of the wave-shaped bar structure 2a.

[0086] In this embodiment, referring to FIG. 1( b ) and Figure 4 , a wire loop 5 is provided on the inner side of the inflow end of the positioning member 2, and the wire loop 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 loop 5 is as follows Figure 1(a) to Figure 2(b) 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, and 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 smoothly capture the native valve leaflet.

[0087] Reference Figure 4 The covering film 3 is connected to the positioning rods 21 and the connecting rods 51 on both sides of the inflow end of the positioning piece by sutures 31. In this way, the covering film 3 can be reliably fixed to the inflow end of the positioning piece on both sides and in the middle 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 its lower part connected to the inflow end of the positioning member 2 is regarded as a connecting rod 51.

[0089] In this embodiment, referring 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 pull ring 5 to prevent the coating 3 from sliding axially.

[0090] In this embodiment, referring to Figure 5 To prevent stent coating 3 from abrading, a polymer film 4 is disposed on the inner side of the coating 3, specifically between the coating 3 and the positioning element 2, creating a double-layered covering structure at the inflow end of the positioning element 2. This double-layered covering effectively prevents stent coating 3 from abrading. Furthermore, the coating 3 and the polymer film 4 form a double-layered covering structure that covers the inflow end of the positioning element, increasing its elasticity and further reducing damage to the aortic sinus floor from the inflow end of the positioning element.

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

[0092] In this embodiment, the polymer film 4 is made of 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 portion of the inflow end of the positioning member 2 is a bent structure, and there is at least another bent structure on both sides of the bent structure to form a wave rod structure 2a.

[0095] Specifically, such as Figure 3As shown, in the compressed state, the middle portion of the inflow end of the positioning member 2 forms a U-shaped bend. 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 positioned on the upper side of the U-shaped structure, preferably in the middle of the upper side of the U-shaped structure. A bend similar to an inverted U-shaped structure is formed on each side of the U-shaped structure, resulting in a wave-shaped rod structure 2a having three bends 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 delivered, 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, referring 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 at the inflow end of the retainer 1 effectively prevents blood from flowing back, blood can still flow out of the U-shaped structure at the inflow end of the retainer 1 and pass through the gap between the anchor portion 8 and the inner wall of the aorta, causing paravalvular leakage. To address the problem of paravalvular leakage, the present application provides a leak-proof membrane 11 connected to the U-shaped structure at the inflow end of the retainer 1.

[0100] In this embodiment, referring to FIG9( 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 extend beyond 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 and has no fixed edge. An excessively long outflow end edge of the inner leak-proof membrane 111 may cause it to fluctuate with blood flow, resulting in instability of the regurgitant valve stent and multiple collisions with the prosthetic valve leaflets.

[0101] In this embodiment, referring to FIG9(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. This design makes up for the shortcomings of the inner leak-proof membrane: when the artificial valve leaflets are opened, the outflow end of the inner leak-proof membrane 111 is too close to the artificial valve leaflets, and the inner leak-proof membrane 111 often rubs against the artificial valve leaflets, thereby causing damage to the artificial valve leaflets. 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, causing 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 and causing 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 the damage that the outer leak-proof membrane 112 may cause to the artificial valve leaflets. 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 and has no fixed edge. 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 this 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 this 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, such as 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 end of the inner leak-proof membrane 111 and the outer leak-proof membrane 112.

[0103] Example 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. One positioning member 7 is provided for each retaining member 6, the outflow end of the positioning member 7 being fixedly connected to the outflow end of the retaining member 6, and the inflow end of the retaining member 6 being provided with an anchoring portion 8. The anchoring portion 8 is provided with a plurality of barbs 9 along its circumference, with the free ends 9a of the barbs 9 being disposed opposite 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 achieving 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. Therefore, the present invention utilizes the cooperation of the positioning member 7 and the barb 9 to clamp the aortic valve ring 10, thereby achieving a firm fixation of the stent. Secondly, it is clinically found that in the case of aortic valve leaflets (normally tricuspid valves) with bicuspid valves, quadcuspid valves or deformed 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 achieve a firm fixation of the stent in the case of bicuspid valves, quadcuspid valves or deformed 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 this embodiment, another structure of the barb is provided. The middle width of the barb 9 is greater than the width of the two ends of the barb, that is, the inflow end of the barb is narrower. First, it can reduce the space occupied by the barb 9 on the anchoring part and reduce the internal stress generated at the connection between the barb 9 and the anchoring part 8 during the compression process. Secondly, it can make the barb 9 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 part can make the barb better riveted into the human tissue. It should be stated here that no matter which form of the above-mentioned barb structure, it can be used as the barb 9 of this application.

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

[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 FIG6( 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 so as to tilt outwards and then inwards from the inflow end to the outflow end until they are parallel to the axis of the regurgitant valve stent. This 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 tilted outwards are difficult to provide circumferential riveting force to the stent. Therefore, the barbs 9 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 9 that are tilted inwards are inserted into human tissue, their free ends 9a are 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 part 8 can be effectively fitted, which not only prevents the circumferential shaking of the stent, but also reduces paravalvular leakage between the aortic valve ring and the anchoring part 8.

[0114] If the barbs 9 that are only tilted outward cannot fully penetrate the human tissue, the barbs 9 will easily scratch and tear the human tissue when the stent is subjected to axial force. However, the barbs 9 with relatively inward tilted free ends 9a will not scratch or tear the human tissue because the free ends 9a are substantially parallel to the axis of the stent. Moreover, when the stent is subjected to a force away from the ventricle, the barbs 9 can penetrate deeper into the human tissue, thus more securely fixing the stent. Conversely, when the stent is subjected to a force toward the ventricle, the stent will not move significantly toward the ventricle due to the restriction of the positioning member 7. Since the free ends 9a of the barbs 9 are parallel to the axis of the stent, the sliding of the barbs 9 will not completely separate the barbs 9 from the inserted human tissue, so the barbs 9 will not be repeatedly pulled out and reinserted into the human body.

[0115] Since the anchoring portion 8 needs to be compressed and placed into the loading chamber, and the barb 9 that is only tilted 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 insert into the loading chamber, causing the loading chamber to be unable to move smoothly, making it impossible to release the stent anchoring portion 8, 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 tilted 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, and 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 FIG1(b), a wire loop 5 is provided on the inner side of the inflow end of the positioning member 2, and the wire loop 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 loop 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, and 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 part 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 part 8 expands, the barb 9 cannot immediately penetrate into the human tissue / aortic valve ring. The anchoring part 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 rest against the bottom of the aortic sinus. When the stent is subjected to blood pressure toward the inflow end (pointing toward the ventricle), due to The positioning member 2 does not rest firmly against the aortic valve ring, so the stent will move toward the ventricle, which will increase the risk of the barb 9 coming out of the human tissue, and thus cause the stent to be unreliably fixed. As shown in Figure 11(c), the positioning member can now be controlled to open to a certain angle by a pull wire. During the opening process 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 moving 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 wire, and the inflow end of the positioning member 2 rests against the bottom of the aortic sinus, and the barb 9 also penetrates the human tissue, so that the positioning member 2 and the barb 9 form a good clamping shape for 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, referring 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 can include one, two, or three barbs 9, which correspond to each other and clamp the valve annulus. The two barbs are preferably evenly distributed along the circumference of the regurgitant valve stent to ensure balanced stress on the stent. As shown in Figure 8(b), a group of barbs 9 includes three barbs 9, of which the middle barb 9 is located 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 divided into the middle position, and 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 anchor portion 8 .

[0121] In this embodiment, the axial distance between the inflow end of the positioning member 7 and the inflow end of the regurgitant valve stent does not exceed 15 mm, preferably 6 mm to 10 mm, to prevent the stent from excessively extending 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, resulting in the anchoring portion 8 forming a middle outward expansion structure.

[0123] As shown in FIG10( a ), the outer diameter of the outflow end of the anchor portion 8 is D1 , the outer diameter of the middle portion of the anchor portion 8 is D2 , and the outer diameter of the inflow end of the anchor portion 8 is D3 , then, D2 > D1 and D2 > D3 .

[0124] With the above design, the middle portion of the anchoring portion 8 is outwardly expanded relative to the outflow end, which is conducive to the anchoring portion 8 being stably stuck in the valve annulus and maintaining the stability of the stent, while the inflow end of the anchoring portion 8 is retracted relative to the middle portion, preventing the inflow end from touching the ventricular outflow tract wall and preventing the 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 diamond-shaped grids circumferentially, thereby maintaining the compressibility of the anchoring portion 8. In other embodiments, the anchoring portion 8 may also be a folded line structure or other compressible and expandable structure.

[0126] In this embodiment, the anchoring portion 8 is formed by circumferentially connecting several diamond-shaped grids with their middle portions expanded outward. At this time, in order to allow the barbs 9 to still be smoothly inserted into the valve ring, referring to Figure 10(a), the inflow end of the barb 9 can be set 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 the plurality of diamond-shaped grids expand outward to form a middle-outward expansion structure.

[0128] The circumferential connection point of several diamond-shaped grids can be considered as 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 FIG10( a ), 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 annulus is generally 20mm to 30mm. The aortic valve diameter of patients with annular dilatation increases by 1mm to 5mm, and in some patients, by 8mm or even more. The diameter of the regurgitant valve stent is generally set to correspond to the diameter of the aortic valve annulus (according to the size of the diseased aortic valve annulus). Therefore, the product diameter can vary, such as TARV 23 (23mm outer diameter of the outflow end of the regurgitant valve stent anchoring portion), TARV 31 (31mm outer diameter of the outflow end of the regurgitant valve stent anchoring portion), etc. If the number of diamond grids remains unchanged, if the anchoring portion 8 is formed by overly slender diamond grids, its radial support force is relatively small. If the diamond grids are too short, deformation is difficult, which easily leads to stress concentration and is not conducive to stent compression. In other words, the diamond grids are too short and have poor resilience, making it difficult for the compressed stent to return to its original 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 by designing the outward expansion structure of the middle part of the anchoring portion 8. Under the conditions that the circumference of the inflow end of the regurgitant valve stent remains unchanged and the number of diamond grids remains unchanged, a more reasonable prismatic grid of 2X / Y can be set.

[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] A too small retraction angle α results in ineffective retraction of the inflow end of the anchoring portion 8, leaving a high probability of the inflow end of the anchoring portion 8 contacting the ventricular outflow tract. However, a too large retraction angle α can cause the membrane-covered anchoring portion 8 to block blood flow through the ventricular outflow tract, increasing resistance (and reducing the effective opening area of ​​the valve) and hindering endothelialization of the anchoring portion 8. The present invention avoids these 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, where 32°≤α≤36°. This restriction not only prevents the inflow end of the anchoring portion 8 from contacting the ventricular outflow tract, but also prevents the retracted inflow end of the anchoring portion from causing significant resistance to blood flow and facilitates endothelialization of the inflow end of the regurgitant valve stent.

[0137] In this embodiment, a coating is provided only between the middle of the anchoring portion 8 and the outflow end of the anchoring portion 8, and 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 a 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 in the diamond grid without forming human tissue protruding relative to the surface of the ventricular outflow tract, which can prevent the retracted 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] 9( d ), in this embodiment, 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 retaining member 6 is provided with an inner leak-proof membrane 111, the covering 100 is connected to the inner leak-proof membrane 111, or the inner leak-proof membrane 111 is not provided, and the covering 100 covers the U-shaped structure of the retaining member 6.

[0143] 10( c ), if an outer anti-leakage membrane 112 is provided at the U-shaped structure of the retainer 6 , the covering film 100 is connected to the inner anti-leakage membrane 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 Example 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 Example 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, the "distal end" refers to the side of the delivery system away from the end manipulated by the user) includes a hook covering tube 301, and a middle tube 304 is arranged inside the hook covering tube 301. The distal end of the middle tube 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 matches the distal end shape of the middle tube 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 bracket 1000 can be stably confined in the groove 30401 in the axial direction, as shown in Figure 12 (b). The ear-shaped covering tube 301 surrounds the middle conduit 304, preventing the connecting portion 500 of the stent 1000 from popping out of the groove 30401. This also keeps the outflow end of the stent 1000 in a compressed state. An inner conduit 302 is disposed within the middle conduit 304. The inner conduit 302 passes through the interior of the stent 1000 and is connected to a cannula 303 at its distal end. The cannula 303 is disposed outside the distal end of the inner conduit 302, leaving a gap between the cannula 303 and the inner conduit 302 for mounting the stent 1000. It should be noted that, as shown in FIG12( a ), only the anchoring portion 8 of the stent 1000 is contained within the cannula 303, i.e., within the gap between the cannula 303 and the inner conduit 302. The positioning member 2 is retracted by the sheath system 400, ensuring that the inflow end of the stent 1000 is compressed and ultimately delivered in this 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 part 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. However, due to the curved design of the barb 9, after the anchoring part 8 expands, the barb 9 cannot immediately penetrate into the human tissue / aortic valve ring. The anchoring part 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 rest against the bottom of the aortic sinus. When the stent is subjected to blood pressure toward the inflow end (pointing toward 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 falling 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 member can be controlled to open to a certain angle by pulling the wire. During the process of opening 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 pulling the wire, and the inflow end of the positioning member 2 is against the bottom of the aortic sinus, and the barb 9 also penetrates the human tissue, so that the positioning member 2 and the barb 9 form a good clamping shape for the aortic valve ring, achieving a better clamping effect, that is, by repeatedly opening the positioning member 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 member 2.

[0151] Next, the ear-loop covering tube 301 is retracted, causing the connection portion 500 of the stent 1000 to lose its circumferential restraint and pop out of the groove 30401. The outflow end of the stent 1000 is now free from the distal end 300 of the delivery system, completing the release of the entire stent 1000, as shown in Figure 12(c). The delivery system 2000 is then withdrawn from the body, leaving the stent 1000 stably retained in the heart.

[0152] In some embodiments, reference Figure 1312( b ), the distal end 300 of the delivery system includes a hook wrap tube 301, a middle conduit 304 is provided inside the hook wrap tube 301, and a groove 30401 matching the connecting portion 500 of the stent 1000 is provided at the distal end of the middle conduit 304, and 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, and 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 part of the inner catheter 302. There is a gap between the sleeve 303 and the inner catheter 302 for installing the stent 1000. It should be noted that the sleeve 303 retracts the inflow end of the stent 1000, including the inflow end of the positioning member 2 and the anchoring portion 8, into the interior of its sleeve 303, that is, 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 first pushed forward to release the positioning member 2 from the sleeve 303. Of course, by pulling back the ear cover tube 301 and the middle catheter 304 together, the stent 1000 is moved backward to release the positioning member 2 from the sleeve 303. Alternatively, the positioning member 2 can be aligned with the native aortic valve leaflets, and the ear cover tube 301 and the middle catheter 304 (or the ear cover tube 301, the middle catheter 304 and the inner catheter 302) are pushed forward to allow the positioning member 2 to capture the native valve leaflets, that is, to insert the positioning member 2 into the aortic sinus. At this time, 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 barb 9 adjustment step is performed. Then pull back the ear-hanging covering tube 301 or push forward the middle tube 304, so that the connecting part 500 of the stent 1000 or the groove 30401 of the middle tube 304 is out of the coverage of the ear-hanging covering tube 301. At this time, the connecting part 500 of the outflow end of the stent 1000 has no radial expansion resistance. Under the expansion action of the stent 1000, the connecting part 500 pops out from 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 has been described in detail above with reference to the embodiments of the accompanying drawings. A person skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention. The scope of protection of the present invention shall be determined by the scope defined by the appended 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 the outflow end of the retaining member, and an inflow end of the retaining member is provided with an anchoring portion; the positioning member cooperates with the retaining member to capture the native valve leaflet; It is characterized in that The anchoring portion is provided with a plurality of barbs on its circumference, wherein the free ends of the barbs are arranged opposite to the inflow end of the positioning member, and the barbs are used to be inserted into human tissue, and the positioning member cooperates with the barbs to clamp the aortic valve ring; The inflow end of the barb is connected to the anchor portion as a fixed end, and the outflow end of the barb is arranged as a free end opposite to the inflow end of the positioning member; 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; 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.

2. The regurgitant valve stent according to claim 1, wherein: The axial distance between the inflow end of the positioning member and the free end of the barb is H, where 1 mm ≤ H ≤ 6 mm; and / or, the length of the barb is not less than 1.0 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.

3. The regurgitant valve stent according to claim 2, wherein: 2mm≤H≤4mm, the length of the barb is not less than 2mm; the axial distance from the inflow end of the positioning member to the inflow end of the regurgitant valve stent is 6mm~10mm.

4. The regurgitant valve stent according to claim 1, wherein: The width of the middle portion of the barb is greater than the width of the two ends of the barb.

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

6. The regurgitant valve stent according to claim 4, wherein: 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, wherein: The number of groups of barbs is consistent with the number of 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, wherein: The anchoring portion is formed by connecting a plurality of diamond-shaped grids with their central portions expanding outwards in a circumferential direction; The inflow end of the barb is arranged at the connection of two adjacent diamond-shaped grids.

9. The regurgitant valve stent according to any one of claims 1 to 8, wherein: 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 spans the inflow end of the retaining member in an expanded state.

10. The regurgitant valve stent according to claim 9, wherein: The inflow end of the positioning member is covered with a positioning member coating.

11. The regurgitant valve stent according to claim 10, wherein: The covering film is 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 through 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 through sutures.

12. The regurgitant valve stent according to claim 11, wherein: The middle part of the covering is fixed by passing a suture through the pull-wire ring.

13. The regurgitant valve stent according to claim 10, wherein: 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.

14. The regurgitant valve stent according to claim 13, wherein: The covering film is animal tissue.

15. The regurgitant valve stent according to claim 14, wherein: The animal tissue is bovine pericardium or porcine pericardium; the material of the polymer membrane is PET, ePTFE or FEP.

16. The regurgitant valve stent according to claim 1, wherein: The barbs are adjusted in the following manner: After the anchoring portion of the regurgitant valve stent is released through a delivery system and the anchoring portion is expanded, the positioning member is controlled to open to a preset angle by a pull wire, wherein the pull wire is connected to a pull wire ring provided on the inner side of the inflow end of the positioning member; Moving the regurgitant valve stent toward the inflow end through the delivery system, and after moving to a preset distance, pulling the regurgitant valve stent toward the outflow end through the delivery system so that the barbs are 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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