Anti-leak reflux stent

Abstract

The application discloses a reflux support capable of preventing peripheral leakage, which comprises a plurality of holding members, a plurality of positioning members and an anchoring part, one positioning member is arranged on the upper side of one holding member in correspondence, the outflow end of the positioning member is fixedly connected with the outflow end of the holding member, the inflow end of the holding member is provided with the anchoring part, the inflow end of the holding member is in U-shaped structure, and a leakage-proof membrane is connected to the U-shaped structure of the holding member. The reflux support capable of preventing peripheral leakage is provided with the leakage-proof membrane at the U-shaped structure of the inflow end of the holding member, the inner leakage-proof membrane is arranged to effectively avoid the occurrence of blood valve peripheral leakage, the outer leakage-proof membrane is tightly combined with the inner wall of the aortic blood vessel, the outer leakage-proof membrane further prevents the occurrence of blood peripheral leakage, and the outer leakage-proof membrane is arranged on the outer side of the support, so that the outflow end of the outer leakage-proof membrane is effectively prevented from rubbing against the artificial valve leaf, and the damage to the artificial valve leaf is reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a reflux stent that prevents leakage. Background Technology

[0002] The aortic valve is located between the left ventricle and the aorta. Its main function is to prevent blood ejected into the aorta from flowing back into the left ventricle. If aortic valve insufficiency occurs, blood will flow back from the aorta into the left ventricle, which is what we commonly call aortic regurgitation. Aortic regurgitation increases the workload on the left ventricle, and severe regurgitation can lead to heart failure and ultimately sudden death.

[0003] Traditional aortic valve replacement surgery is a surgical procedure that requires patients to undergo open-chest surgery and establish cardiopulmonary bypass. As a result, it is not only expensive but also carries significant surgical risks, and patients have a long recovery time after surgery.

[0004] In recent years, with the continuous improvement of medical standards, TAVI technology has developed rapidly. As the third mode after surgical aortic valve replacement and drug therapy, transcatheter aortic valve implantation has begun to receive more and more attention from the public due to its use of minimally invasive cardiac catheter technology, which does not require open-chest surgery, resulting in less trauma, shorter operation time, and faster patient recovery. The development of TAVI technology is also changing rapidly.

[0005] A regurgitation stent is proposed in Chinese patent: Stent for positioning and anchoring valve prosthesis at the implantation site in a patient's heart (Publication No.: CN102413793A). It discloses a retaining arc, but the distance between the inflow end of the retaining arc and the annular ring is the shortest. Therefore, the contact area between the stent and the inner wall of the aorta is the smallest. As a result, blood leakage is very likely to occur at this location. Moreover, the stent cannot effectively prevent the stent from moving away from the heart, that is, moving away from the left ventricle along the aorta.

[0006] Therefore, a reflux stent to prevent paravalvular leakage is proposed. Its structure is simple and requires only a small modification, but it solves the long-standing problem of paravalvular leakage and the stent can be securely fixed. Summary of the Invention

[0007] This invention addresses the technical problem of perivalvular leakage in existing reflux stents, aiming to provide a reflux stent with a simple structure that solves the problem of perivalvular leakage.

[0008] One of the objectives of this invention is to provide a backflow support for preventing leakage, which includes multiple retaining members, multiple positioning members, and an anchoring part. A positioning member is correspondingly provided on the upper side of one of the retaining members. The outflow end of the positioning member is fixedly connected to the outflow end of the retaining member. The anchoring part is provided on the inflow end of the retaining member. The inflow end of the retaining member has a U-shaped structure, and a leak-proof membrane is connected to the U-shaped structure of the retaining member.

[0009] Preferably, the leak-proof membrane includes an inner leak-proof membrane that covers the inside of the U-shaped structure of the retainer.

[0010] Preferably, the leak-proof membrane further includes an outer leak-proof membrane that covers the outside of the U-shaped structure of the retainer.

[0011] Preferably, the inflow end of the retainer is connected to the outflow end of the anchoring part, and the outer side of the inflow end of the anchoring part is covered with an outer skirt.

[0012] Preferably, the outer skirt is integrally connected to the outer leak-proof membrane.

[0013] Preferably, the inner side of the backflow bracket is provided with a membrane covering the inflow end of the retainer to the anchoring part, and the membrane is connected to the outer skirt.

[0014] Preferably, the coating is connected to the outer skirt by stitching, adhesive bonding, or integral molding.

[0015] The present invention can further solve the technical problem that the stent cannot be securely fixed to the heart implantation site in the prior art. In order to solve this technical problem, the present invention provides a plurality of barbs in the circumferential direction of the anchoring part of the regurgitation stent, and the barbs are inclined outward at 5° to 15°.

[0016] Preferably, the anchoring part is formed by connecting several diamond-shaped grids laterally, and the inflow end of the barb is connected to the inflow end of the anchoring part.

[0017] Preferably, at least one of the positioning elements can control its opening angle relative to the support axis.

[0018] Preferably, the positioning element is controlled by a pull wire, and the opening angle range of the positioning element relative to the axis of the support is 20° to 60° under the control of the pull wire.

[0019] Preferably, the positioning element is controlled by a pull wire, and the opening angle range of the positioning element relative to the axis of the bracket is 60° to 90° under the control of the pull wire.

[0020] Preferably, the inflow end of the positioning element is provided with a pull wire hole.

[0021] Preferably, the positioning element and the retaining element have cooperative shapes that can hold the native leaflet of the heart valve between the positioning element and the retaining element.

[0022] Preferably, a reinforcing member is provided in the middle of the positioning member, and the two ends of the reinforcing member are respectively connected to the inner sides of the two sides of the positioning member.

[0023] Preferably, the outlet end of the positioning member and the outlet end of the retaining member are fixedly connected by an extension rod.

[0024] The positive and progressive effects of this invention are as follows:

[0025] This invention goes beyond simply covering the inflow end of the retainer to the anchoring portion with a membrane. The anti-perivalvular leakage stent of this invention further incorporates an anti-leakage membrane at the U-shaped structure of the inflow end of the retainer. This anti-leakage membrane effectively prevents blood perivalvular leakage. Furthermore, the anti-leakage membrane of this invention can consist solely of an inner anti-leakage membrane located inside the stent, or solely of an outer anti-leakage membrane located outside the stent, or simultaneously of both inner and outer anti-leakage membranes. The outer anti-leakage membrane adheres tightly to the inner wall of the aorta, further preventing blood perivalvular leakage. The design of the outer anti-leakage membrane being located outside the stent effectively prevents friction between the outflow end of the outer anti-leakage membrane and the artificial valve leaflet, thereby reducing damage to the artificial valve leaflet. In addition, this invention also covers the outer side of the inflow end of the anchoring portion of the regurgitation stent with an outer skirt, further improving the anti-perivalvular leakage performance of the regurgitation stent.

[0026] The anti-peripheral leakage reflux stent of the present invention has several barbs in the circumferential direction of the anchoring part. In practical application, the barbs are inserted into the ventricular wall or valve annulus, which can effectively prevent the stent from moving away from the heart along the aorta, so that the stent can be securely fixed at the heart implantation site. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the anti-leakage backflow support of the present invention;

[0028] Figure 2 for Figure 1 A front view of the anti-flow bracket in the middle;

[0029] Figure 3 This is a schematic diagram of the structure of the anti-flow support in one embodiment of the present invention;

[0030] Figure 4 for Figure 3 The unfolded diagram of the anti-flow support in the middle;

[0031] Figure 5 for Figure 4 A magnified view of a portion of the image;

[0032] Figure 6 This is a schematic diagram of the structure of the reflux support in another embodiment of the present invention;

[0033] Figure 7 for Figure 6 The unfolded diagram of the anti-flow support in the middle;

[0034] Figure 8 for Figure 7 A magnified view of a portion of the image;

[0035] Figure 9 This is a schematic diagram of the structure of the reflux support in another embodiment of the present invention;

[0036] Figure 10 for Figure 9 The unfolded diagram of the anti-flow support in the middle;

[0037] Figure 11 for Figure 10 A magnified view of a portion of the image;

[0038] Figure 12 for Figure 1 A schematic diagram showing the connection between the central counterflow support and the C-type component;

[0039] Figure 13 for Figure 12 A magnified view of a portion of the text;

[0040] Figure 14 This is a structural diagram of a C-type component;

[0041] Figure 15 for Figure 1 The unfolded diagram of the anti-flow support in the middle;

[0042] Figure 16 for Figure 15 A magnified view of a portion of the text;

[0043] Figure 17 for Figure 16 A magnified view of a portion of the text;

[0044] Figure 18 This is a schematic diagram of a reflux support structure according to another embodiment of the present invention;

[0045] Figure 19 for Figure 18 A magnified view of a portion of the text;

[0046] Figure 20 for Figure 18 The unfolded diagram of the anti-flow support in the middle;

[0047] Figure 21 This is a schematic diagram of the compression state structure of the reflux support according to another embodiment of the present invention;

[0048] Figure 22 for Figure 21 A magnified view of a portion of the text;

[0049] Figure 23 This is a schematic diagram of the structure of the reflux support, membrane, artificial valve leaflet and inner leak-proof membrane of the present invention;

[0050] Figure 24 This is a schematic diagram of the structure of the reflux stent, the membrane, the artificial valve leaflet, the inner leak-proof membrane, and the outer leak-proof membrane of the present invention.

[0051] Figure 25 This is a schematic diagram of the structure of the external leak-proof membrane of the present invention;

[0052] Figure 26 This is a schematic diagram of the structure of the reflux support, membrane, artificial valve, inner leak-proof membrane, outer leak-proof membrane and outer skirt of the present invention;

[0053] Figure 27 This is a schematic diagram of the structure of the artificial leaflet and the anti-wear strip of the present invention;

[0054] Figure 28 This is a developed view of the anti-wear strip of the present invention;

[0055] Figure 29 This is a schematic diagram of an artificial leaflet, anti-abrasion strip, and coating structure according to the present invention;

[0056] Figure 30 This is a schematic diagram of another artificial petiole, anti-abrasion strip, and coating structure of the present invention;

[0057] Figure 31 A schematic diagram showing the capture of the positioning element of the regurgitation stent of the present invention being opened to align with the native aortic valve leaflets;

[0058] Figure 32 This is a schematic diagram showing the positioning element of the regurgitation stent of the present invention aligned with the native aortic leaflet and inserted into the aortic sinus;

[0059] Figure 33 This is a schematic diagram of the sheath system, delivery system, and support in one embodiment of the present invention;

[0060] Figure 34 for Figure 33 A schematic diagram of the sheath removal system of the delivery system of the present invention;

[0061] Figure 35 for Figure 33 A schematic diagram of the structure of the conveying system of the present invention with the ear-covered tube removed from the distal portion;

[0062] Figure 36 for Figure 33 A schematic diagram of the structure of the conveying system of the present invention with the support fully released;

[0063] Figure 37 This is a schematic diagram of the structure of the remote portion of the conveying system in another embodiment of the present invention;

[0064] Figure 38 for Figure 37 A schematic diagram of the structure of the conveying system of the present invention with the ear-covered tube removed from the distal portion;

[0065] Figure 39 This is an unfolded view of a reflux support according to another embodiment of the present invention;

[0066] Figure 40 This is an unfolded view of a reflux support according to another embodiment of the present invention;

[0067] Figure 41 This is a schematic diagram of the aortic native leaflet. Detailed Implementation

[0068] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0069] It should be noted that in this text, the height direction is essentially along the axis of the artificial heart valve. Except for the specific description shown in the figure, the terms "high," "low," "up," and "down" directly mentioned in this text refer to the state closer to the inflated state (e.g., ...). Figure 1 (As shown) The location of the outflow end of the artificial heart valve, where "low" or "down" refers to its position near the inflow end when the valve is inflated, and "inflow end" refers to its upstream position in the direction of blood flow, i.e., the end where the stent first passes through the blood when inflated. Figure 2 The inflow end is shown as 1000; its "outflow end" refers to the downstream position in the direction of blood flow, that is, the end of the stent when the blood leaves the expanded state, such as... Figure 2 The outflow end shown is 2000.

[0070] like Figures 1 to 2As shown, the anti-peripheral leakage regurgitation stent of the present invention includes multiple retaining members 1, multiple positioning members 2, and an anchoring part 8. A positioning member 2 is correspondingly disposed on the upper side of each retaining member 1. The outflow end of the positioning member 2 is fixedly connected to the outflow end of the retaining member 1. The inflow end of the retaining member 1 is provided with an anchoring part 8, and the anchoring part 8 is provided with a plurality of barbs 12 in the circumferential direction. The inflow ends of the barbs 12 are connected to the inflow ends of the anchoring part 8. In practical applications, the original valve leaflet is held by the positioning members 2 and retaining members 1, the anchoring part 8 is secured to the aortic valve annulus, and the barbs 12 are inserted into the ventricular wall or valve annulus, allowing the regurgitation stent to be reliably and stably fixed at the position of the original aortic valve.

[0071] However, during transcatheter regurgitation stent implantation, it is necessary to use positioning element 2 to capture the native leaflet. That is, positioning element 2 needs to be inserted into the non-closed surface of the native leaflet, while retaining element 1 is located on the closed surface of the native leaflet, so that retaining element 1 and positioning element 2 clamp the native leaflet. However, since the aortic native leaflet is generally composed of three native leaflets, there are generally at least three positioning elements 2, corresponding to all the native leaflets that need to be captured. Positioning element 2 can easily capture two of the native leaflets, but capturing all three native leaflets at once is relatively difficult. This is because when the three native leaflets are arranged in a circle and the positioning element 2 is aligned with the native leaflets, the positioning element 2 will inevitably move away from and towards the non-closed surface of the native leaflets when the support 100 is moved in the horizontal direction (vertical to the axis of the support 100). Moreover, the native leaflets are also mobile under the influence of blood, so the timing of their capture is also very important. Therefore, it is relatively difficult for all positioning elements 2 to capture all three native leaflets at once, which will prolong the operation time due to the inability to capture all three native leaflets. Therefore, in order to better capture the native leaflets, the opening angle of at least one of the positioning elements 2 can be controlled. Here, a pull line can be used to control the opening angle between the positioning element 2 and the axis of the support 100. By using the pull line to open the positioning element 2 to a larger angle, it is easier for it to approach the non-closed surface of the native leaflets, thus facilitating the positioning element 2 to capture the native leaflets without the need to move and adjust the support 100 in the horizontal direction.

[0072] In some embodiments, the positioning member 2 is controlled by a pull wire. Under the control of the pull wire, the opening angle of the positioning member 2 relative to the axis of the support 100 is in the range of 20° to 60°, such as 21°, 23°, 25°, 28°, 30°, 33°, 35°, 38°, 40°, 43°, 45°, 48°, 50°, 53°, 55°, 58°, and 60°. When the positioning member 2 is captured or aligned with the non-closed surface of the original leaflet, the support 100 can be moved horizontally without needing to move the support 100. By opening the positioning member 2 at a larger angle, a larger radial extension dimension can be obtained, and the positioning member 2 can be aligned with the non-closed surface of the original leaflet, so that the positioning member 2 of the support 100 can successfully capture the original leaflet.

[0073] In some embodiments, the positioning element 2 is controlled by a pull wire. Under the control of the pull wire, the positioning element 2 can open to an angle range of 60° to 90° relative to the axis of the support 100. A larger opening angle, such as close to 90°, serves another primary purpose: to allow for remediation if the positioning element 2 fails to capture the native leaflet. That is, although the positioning element 2 can be opened to a larger angle (e.g., before capturing the native leaflet) by the pull wire control, it can still provide a remedy. Figure 31 (As shown) to facilitate the capture of the native leaflet, and then the positioning element 2 is pushed into the non-closed surface of the native leaflet (as shown). Figure 32 As shown, the stent 100 is being moved towards the ventricle. However, due to reasons such as movement of the native leaflet during the movement of the positioning element 2, poor imaging angle, or unclear imaging leading to observation errors, the positioning element 2 fails to successfully insert into the non-closed surface of the native leaflet. Traditional stents 100, which cannot control the opening angle of the positioning element 2, can only be retracted, i.e., the positioning element 2 is removed from the non-closed surface of the native leaflet, requiring a re-capture of the native leaflet. Now, the positioning element 2 can open at a larger angle, such as 75°, 76°, 77°, 78°, 79°, 80°, 81°, 82°, 83°, 84°, 85°, 86°, 87°, 88°, 89°, and 90°. Without retracting the stent 100, the non-closed surface of the native leaflet can be successfully re-captured. The inflow end of the positioning element 2 on the non-closed surface of the native leaflet is opened to a position higher than the outflow end of the uncaptured native leaflet. Then, the positioning element 2 is lowered, which realizes the secondary capture of the native leaflet. Since the stent 100 is in a compressed state at this time, there is enough space in the aorta to open the positioning element 2. Although the inflow end of the positioning element 2 may touch the aortic wall, the duration is short, that is, it will not open again later. The inflow end of the positioning element 2 no longer touches the aortic wall, and it is opened in the state of the stent 100 being compressed. That is, opening the positioning element 2 in the state of the stent 100 compression will not form an excessively large horizontal outer contour size of the stent 100, that is, it will not generate a large force on the aortic wall. Therefore, the positioning element 2 can be opened at a relatively large angle under the control of the pull wire to capture the native leaflet for a second time.

[0074] In some embodiments, such as Figures 3-5 As shown, one or more pull wire holes 77 can be directly provided at the inflow end of the positioning member 2. The structure is simple. The pull wire hole 77 is used to pass a pull wire through, and the positioning member 2 can be opened to a larger angle by using the pull wire through the pull wire hole 77.

[0075] In some embodiments, such as Figures 6-8 As shown, a pull ring 7A is provided on the inner side of the inflow end of the positioning member 2. Here, 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, its concave side (i.e., the upper side) is its inner side. Obviously, the position of the pull ring 7A is as follows: Figures 6-8This is also clearly stated in the text. Because directly setting the pull wire hole 77 at the inflow end of the positioning member 2 may reduce the strength of the inflow end of the positioning member 2, which is not conducive to the compression and expansion of the inflow end of the positioning member 2. Therefore, the pull wire ring 7A is provided with a pull wire hole 77. The pull wire hole 77 is used to pass the pull wire through the pull wire hole 77, and the pull wire is used to control the positioning member 2 to open to a larger angle through the pull wire hole 77.

[0076] In some embodiments, such as Figure 9-11 As shown, a drawstring composite ring 7C is provided on the inner side of the inflow end of the positioning member 2. Here, 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, its concave side (i.e., the upper side) is its inner side. Obviously, the position of the drawstring composite ring 7C is as follows: Figures 9-11 This is also clearly shown in the diagram. Since the positioning element 2 needs to capture the original leaflet, the position of the inflow end of the positioning element 2 is particularly important. In order for the position of the inflow end of the positioning element 2 to be clearly displayed on the imaging device, the inflow end portion of the pull wire composite ring 7C is used for development. The embodiment given here uses a marking embedding hole 7C01 at the inflow end of the pull wire composite ring 7C, and embeds a marker (the marker is not radiolucent) in the marking embedding hole 7C01 to facilitate the precise positioning of the positioning element 2. The positioning element 2 is designed to accurately capture the native leaflet and insert it into the sinus floor. The outlet end of the pull-wire composite ring 7C has a pull-wire hole 77 for the pull-wire to pass through. The pull-wire, passing through the pull-wire hole 77, controls the positioning element 2 to open to a greater angle, facilitating the capture of the native leaflet and reducing operational difficulty. Simultaneously, the pull-wire composite ring 7C structure at the inlet end of the positioning element 2 combines pull-wire control and imaging functions in one location (pull-wire composite ring 7C), effectively improving the product's space utilization. It should be noted that although in such... Figures 9-11 The pull-wire composite ring 7C is shaped like a gourd, but its shape includes, but is not limited to, a gourd shape. The pull-wire composite ring 7C can be rectangular, triangular, elliptical, etc. Moreover, by adopting a specific shape, it can also have the function of assisting recognition. For example, it can be presented as a gourd shape, rectangle, triangle, ellipse, etc. in imaging equipment, which is more conducive to observation.

[0077] In some embodiments, such as Figure 12-14 As shown, by using the wire-drawing composite ring 7C (such as...) Figure 9 As shown, the inflow end of the positioning element 2 is positioned by inserting a marker into the 7C01 hole. While this allows for observation and positioning of the inflow end, it is also limited by the pull wire composite ring 7C (as shown). Figure 9As shown, the size limitation of the inlet-end mark embedding hole 7C01 results in a small volume of the marker, which is not conducive to observation during development, or rather, the small size of the marker makes observation difficult. To enhance the development function of the pull-wire composite ring 7, the pull-wire composite ring 7 includes a connecting rod 702 and a pull-wire ring 701. A C-shaped component 703 is installed on the connecting rod 702. This C-shaped component 703 is made of radiopaque metal, allowing for clear image presentation under imaging equipment. Furthermore, since the C-shaped component 703 is wrapped around the connecting rod 702, as... Figure 14 As shown, the C-shaped component 703 is a component with a cross-section resembling a C shape. The opening of the C-shape can be opened and closed for mounting on the connecting rod 702. The side of the C-shaped component 703 furthest from the axis of the bracket 100 is the outer C-shaped wall 70301, and the side walls sandwiched on both sides of the connecting rod 702 in the circumferential direction are the two C-shaped side walls 70302. To reduce the unevenness of the outer surface of the wire-drawing composite ring 7 caused by the C-shaped component 703, the thickness of the outer C-shaped wall 70301 is less than the thickness of the two C-shaped side walls 70302. Since the C-shaped component 703 is wrapped around the connecting rod 702, its volume is relatively small. The larger size makes observation easier and reduces the difficulty of observation. The inflow end of the connecting rod 702 is fixedly connected to the inflow end of the positioning member 2, and the outflow end of the connecting rod 702 is fixedly connected to the pull wire ring 701. The maximum outline dimension of the pull wire ring 701 is larger than the width (circumferential) dimension of the connecting rod 702, thereby preventing the C-shaped member 703 from slipping off the connecting rod 702 and firmly restricting the C-shaped member 703 between the inner side of the inflow end of the positioning member 2 and the pull wire ring 701. The pull wire ring 701 is provided with a pull wire hole 77, which is used to pass a pull wire. The pull wire is used to control the positioning member 2 to open to a larger angle through the pull wire hole 77.

[0078] In some embodiments, in order to better clamp the native leaflet with the stent 100, the positioning member 2 and the retaining member 1 have cooperative shapes, that is, the shape of the positioning member 2 is approximately the same as that of the retaining member 1, and the native leaflet of the heart valve is clamped between the positioning member 2 and the retaining member 1. Since the shape of the positioning member 2 is approximately the same as that of the retaining member 1, the native leaflet can be securely and effectively fixed.

[0079] In some embodiments, such as Figures 15-17As shown, since the positioning element 2 needs to be inserted into the bottom of the aortic sinus, during the diastolic phase of the heart, i.e., when the left ventricle is in a diastolic state, the aortic valve (artificial heart valve / stent 100) is closed to prevent blood from flowing back from the aorta to the heart. Therefore, the artificial heart valve needs to withstand a certain reverse pressure to prevent blood backflow. Since the positioning element 2 is inserted into the aortic sinus, the inflow end of the positioning element 2 will press down on the bottom of the aortic sinus. In order to prevent the positioning element 2 from puncturing the aortic sinus, the inflow end of the positioning element 2 is made relatively flat to increase the contact area between the inflow end of the positioning element 2 and the bottom of the aortic sinus. Therefore, the diameter of the circle (O1) on both sides of the inflow end of the positioning element 2 is smaller than the diameter of the circle (O2) on the middle part of both sides of the inflow end of the positioning element 2. Furthermore, the inflow end of the positioning element 2 can also be wrapped, for example, by using the same material as the artificial valve leaflet 9 to wrap the inflow end of the positioning element 2, so as to form a relatively soft inflow end of the positioning element 2.

[0080] In some embodiments, such as Figures 18-20 As shown, the outflow end of the positioning element 2 is a wavy curved rod structure 201. This design offers three main advantages: First, when the positioning element 2 clamps the original leaflet, its outflow end corresponds to the outflow end of the original leaflet, i.e., the free end of the original leaflet. The wavy curved rod structure 201 increases the contact area between the positioning element 2 and the original leaflet, effectively increasing the stability of the positioning element 2 clamping the original leaflet. Second, when using a pull wire to control the opening angle of the positioning element 2, the deformation of the opening can be partially achieved by the wavy curved rod structure 201, reducing the deformation amplitude at the outflow end connection of the positioning element 2 and minimizing potential damage to the outflow end connection caused by deformation stress. Finally, the wavy curved rod structure 201 also gives the positioning element 2 a certain degree of elasticity in the axial direction. When blocking blood backflow during diastole, it can buffer the impact of blood backflow, reducing damage to the aortic sinus floor from the inflow end of the positioning element 2. Of course, to further increase the axial elasticity of the positioning element 2, such as... Figures 21-23 As shown, the wavy curved bar structure 201 has a relatively large bending amplitude, such as S-shaped, or the wavy curved bar structure 201 formed by alternating transverse U-shaped structural bars, which can effectively increase the elasticity of the positioning member 2 in the axial direction.

[0081] In some embodiments, a reinforcing member 3 is provided in the middle of the positioning member 2. The reinforcing member 3 effectively increases the contact area between the positioning member 2 and the original leaflet. The two ends of the reinforcing member 3 are respectively connected to the inner sides of the two sides of the positioning member 2. In this embodiment, the reinforcing member 3 has a V-shaped structure, which can realize the compression and expansion of the reinforcing member 3. The two ends of the reinforcing member 3 are relatively close to the outlet end of the positioning member 2, which also effectively increases the circumferential support force of the outlet end of the positioning member 2 and increases the stability of the entire support 100.

[0082] In some embodiments, since each person is an independent individual, there will be slight differences in the aortic valve. Therefore, the outflow end of the positioning member 2 and the outflow end of the retaining member 1 are fixedly connected by the extension rod 4, which increases the adjustment capability of the positioning member 2 relative to the retaining member 1 and can also adjust the length of the entire stent 100 to a certain extent, so as to adapt to a wider range of people.

[0083] In some embodiments, since the inflow end of the retainer 1 is relatively close to the anchoring portion 8, after the stent 100 is installed and expanded, i.e., when the stent 100 is working in the heart, the heart is in diastole (left ventricular diastole). At this time, the blood in the aorta will backflow against the artificial valve leaflet 9. The blood may then flow back along the gap between the original aortic valve leaflet and the stent 100. Obviously, the distance between the inflow end of the retainer 1 and the inflow end of the anchoring portion 8 is relatively short, and the retainer 1 does not have a covering 10 on its upper part, making backflow more likely. Figure 21-22 As shown, the inflow end of the retainer 1 in this application has a teardrop-shaped structure when compressed, and a U-shaped structure when expanded. This design greatly reduces the opening size of the inflow end of the retainer 1 when the stent 100 is working, effectively preventing blood from flowing back through the inflow end of the retainer 1, or in other words, ensuring that the blood backflow is within an allowable range and that a large amount of blood does not flow back through the inflow end of the retainer 1.

[0084] In some embodiments, such as Figure 21-22 As shown, in order to match the shape of the inflow end of the retainer 1, the inflow end of the positioning member 2 has a teardrop-shaped structure when compressed. This design not only matches the retainer 1, but also makes it easier to capture the aortic native leaflet and insert it into the aortic sinus when the positioning member 2 captures the aortic native leaflet, as its circumferential dimension of the inflow end is relatively small.

[0085] In some embodiments, although the U-shaped structure at the inlet end of the retainer 1 effectively prevents blood backflow, blood can still flow out from the U-shaped structure at the inlet end of the retainer 1 and pass through the gap between the anchoring portion 8 and the inner wall of the aorta, thus causing paravalvular leakage. To solve the problem of paravalvular leakage, this application adds an inner leak-proof membrane 1002 to the inner side of the U-shaped structure at the inlet end of the retainer 1, such as... Figure 23 As shown, it should be noted that the outflow end of the inner leak-proof membrane 1002 generally does not exceed the U-shaped structure of the inflow end of the retainer 1. This is because the outflow end of the inner leak-proof membrane 1002 is a suspended edge without a fixed edge. An excessively long outflow end edge of the inner leak-proof membrane 1002 may cause its edge to fluctuate with the blood flow, resulting in instability of the stent 100 and multiple collisions with the artificial valve leaflet 9.

[0086] In some embodiments, such as Figure 24-25 As shown, this application provides an external leak-proof membrane 10A on the outside of the support 100, which covers the U-shaped structure at the inflow end of the retainer 1. This design compensates for... Figure 25 The shortcomings of the inner leak-proof membrane 1002: When the artificial valve leaflet 9 is open, the outflow end of the inner leak-proof membrane 1002 is too close to it, causing frequent friction between the inner leak-proof membrane 1002 and the artificial valve leaflet 9, resulting in damage to the artificial valve leaflet 9. Furthermore, the inner leak-proof membrane 1002 is located inside the stent and cannot fit tightly against the aortic wall, allowing blood to still leak through the gap between the inner leak-proof membrane 1002 and the aortic wall, causing paravalvular leakage. In contrast, the design of the outer leak-proof membrane 10A not only effectively prevents blood from leaking through the U-shaped structure at the inflow end of the retainer 1, but also, because the outer leak-proof membrane 10A fits tightly against the aortic wall, further prevents blood leakage through the gap between the leak-proof membrane and the aortic wall. Meanwhile, the design of the external leak-proof membrane 10A located on the outside of the stent can effectively prevent friction between the artificial valve leaflet 9 and the outflow end of the external leak-proof membrane 10A, and greatly avoid the potential damage to the artificial valve leaflet 9 caused by the external leak-proof membrane 10A. Similarly, the outflow end of the external leak-proof membrane 10A generally does not exceed the U-shaped structure of the inflow end of the retainer 1. This is because the outflow end of the external leak-proof membrane 10A is suspended without a fixed edge. An excessively long edge of the outflow end of the external leak-proof membrane 10A may cause its edge to fluctuate with the blood flow, resulting in instability of the stent 100.

[0087] In some embodiments, the bracket 100 is provided with only an outer leak-proof membrane 10A, or the bracket 100 is provided with only an inner leak-proof membrane 1002. In some embodiments, the bracket 100 may be provided with both an outer leak-proof membrane 10A and an inner leak-proof membrane 1002. Furthermore, when the inner leak-proof membrane 1002 and the outer leak-proof membrane 10A are provided at the same time, the outflow ends of the inner leak-proof membrane 1002 and the outer leak-proof membrane 10A may be connected, for example, by gluing or sewing, thereby increasing the support force of the outflow ends of the inner leak-proof membrane 1002 and the outer leak-proof membrane 10A and reducing the fluctuation between the outflow ends of the inner leak-proof membrane 1002 and the outer leak-proof membrane 10A.

[0088] In some embodiments, such as Figure 1-2 As shown, the inflow end of the retainer 1 is fixedly connected to the anchoring part 8, forming a relatively stable structure.

[0089] In some embodiments, such as Figure 1 As shown, the anchoring part 8 is formed by connecting circumferentially connected diamond-shaped grids, which maintains the compressibility of the anchoring part 8. Furthermore, the anchoring part 8 can also be a broken line structure or other compressible and expandable structures. The diameter of the outflow end of the anchoring part 8 is smaller than the diameter of the inflow end of the anchoring part 8, so that the anchoring part 8 forms a structure in which the inflow end of the anchoring part 8 expands outward relative to the outflow end of the anchoring part 8, so that the anchoring part 8 can reliably contact the valve annulus, thereby limiting the stent 100 from moving away from the heart in the axial direction.

[0090] In some embodiments, such as Figure 1 and Figure 15 As shown, the anchoring portion 8 is provided with barbs 12 in the circumferential direction. The inflow end of the barbs 12 is connected to the inflow end of the anchoring portion 8. The outward tilt angle of the barbs 12 is 5° to 15°, such as 8°, 10°, 13°, etc. When the anchoring portion 8 is in secure contact with the valve annulus, the barbs 12 insert into the ventricular wall or valve annulus, thereby preventing the stent 100 from moving away from the heart along the aorta. It should be noted that the barbs 12 can be evenly distributed in the circumferential direction of the anchoring portion 8 in numbers such as 3 or 6, thereby ensuring that the stent 100 is subjected to uniform force.

[0091] In some embodiments, the barbs 12 are located in the diamond-shaped grid directly below the inflow end of the retainer 1. In this case, the barbs 12 are facing the middle of the native leaflet held by the retainer 1, which helps the barbs 12 to fix the stent more stably. For example, when the barbs 12 cannot penetrate the ventricular wall or valve annulus, since the barbs 12 are facing the middle of the native leaflet, when the stent slides away from the heart, the barbs 12 can be inserted into the native leaflet to continue to maintain the stability of the stent, preventing the stent from moving away from the heart along the aorta, so that the stent can be securely fixed at the heart implantation site.

[0092] In some embodiments, in order to increase the closure performance of the outflow end of the artificial leaflet 9, a leaflet suture hole 401 is provided inside the extension rod 4. The leaflet suture hole 401 is used to fix the outflow end of the artificial leaflet 9. The outflow ends of adjacent artificial leaflets 9 are tightly joined together through the leaflet suture hole 401, which effectively prevents blood from flowing back through the closure of the outflow end of the artificial leaflet 9.

[0093] In some embodiments, such as Figures 26-30 As shown, the artificial leaflet 9 includes an artificial leaflet body 901 and an artificial leaflet ear 902 disposed at the outflow end of the artificial leaflet body 901. The artificial leaflet ear 902 passes through the leaflet suture hole 401 and wraps around the extension rod 4. The inflow end edge of the artificial leaflet body 901 is connected to the covering membrane 10. The covering membrane 10 is installed inside the bracket 100, and the outflow end of the covering membrane 10 is connected to the retainer 1. The inflow end of the covering membrane 10 is connected to the anchoring part 8. An anti-abrasion strip 11 is provided at the connection between the inflow end edge of the artificial leaflet body 901 and the covering membrane 10. The design of the anti-abrasion strip 11 primarily increases the tear resistance of the inflow end of the artificial valve leaflet 9. Secondly, it reduces the damage to the artificial valve leaflet 9 caused by friction between the inflow end of the artificial valve leaflet 9 and the covering membrane 10, thereby improving the service life of the artificial valve leaflet 9. Furthermore, the anti-abrasion strip 11 also acts as a buffer layer between the artificial valve leaflet 9 and the covering membrane 10, effectively buffering the tearing force exerted by the artificial valve leaflet 9 on the covering membrane 10 during opening and closing, thus increasing the service life of the artificial heart valve. Further, the anti-abrasion strip 11 is designed as follows: the anti-abrasion strip 11 has a folded structure (e.g., Figure 23 As shown), the cross-section of the anti-abrasion strip 11 is U-shaped. The inflow edge of the artificial leaflet body 901 is located inside the folded anti-abrasion strip 11, completely wrapping the edge of the artificial leaflet body 901. This effectively increases the tear resistance of the edge of the artificial leaflet body 901. Moreover, when using sutures to fix the artificial leaflet 9 and the covering 10, compared with the use of traditional anti-abrasion strips 11' (such as...), the... Figure 24As shown, the traditional anti-abrasion strip 11' is only located between the artificial leaflet 9 and the diaphragm 10. Therefore, the force generated by the sutures located on the inner side of the artificial leaflet 9 (near the axis of the stent 100) will directly act on the artificial leaflet 9. When the artificial leaflet 9 is subjected to the impact of blood, the connection between the artificial leaflet body 901 and the diaphragm 10 will inevitably be torn to a certain extent. Therefore, the force generated by the sutures located on the inner side of the artificial leaflet 9 (near the axis of the stent 100) can easily damage the artificial leaflet 9, causing the artificial leaflet 9 to fail, and then the entire artificial heart valve to fail. (However, it should be noted that in this application, the connection between the diaphragm 10 and the artificial leaflet 9 can be, but is not limited to, the traditional anti-abrasion strip 11'. The folded, U-shaped anti-abrasion strip 11 completely wraps the edge of the artificial leaflet body 901. The force generated by the sutures is completely applied to the anti-abrasion strip 11, which reduces the tearing force of the sutures on the artificial leaflet 9, improves the service life of the artificial heart valve, and facilitates the long-term operation of the artificial heart valve in the human body.

[0094] In some embodiments, such as Figure 28 As shown, since the edge of the artificial leaflet 9 is curved, material compression and overlap will occur when the anti-wear strip 11 is folded. In order to solve this problem, 3 to 10 stress gaps 1101 are provided in the folded part of the anti-wear strip 11 to reduce the material compression and overlap phenomenon when the anti-wear strip 11 is folded. Here, the stress gaps 1101 can be set on the outside of the fold line 1102 or on the inside of the fold line 1102. Furthermore, the material of the anti-wear strip 11 located on both sides of the fold line 1102 can be a one-piece structure or it can be formed by connecting different materials at the fold line 1102 by sewing, gluing or other means.

[0095] In some embodiments, in order to reduce frictional damage between the anti-wear strip 11 and the artificial petiole 9, and in order to ensure that the anti-wear strip 11 and the artificial petiole 9 have the same mechanical properties as much as possible, so as to ensure that the artificial petiole 9 has better opening and closing stability, the anti-wear strip 11 and the artificial petiole 9 are made of the same material.

[0096] In some embodiments, such as Figure 26As shown, since the outer side of the anchoring part 8 (away from the axis of the stent 100) needs to contact the aortic valve annulus to limit the displacement of the stent 100 in the axial direction away from the left ventricle, the anchoring part 8 will frequently contact the aortic valve annulus. In order to reduce the damage to the valve caused by the exposed anchoring part 8 of the stent 100, the inflow end of the covering 10 is turned outward from the inside of the stent 100 to the outside of the stent 100 to form the outer skirt 1001 of the anchoring part 8. Furthermore, the outer skirt 1001 can be made of a strong and durable material, such as woven PET laser-cut or other materials, or other synthetic or natural materials. The outer skirt 1001 can be an integral structure with the covering 10, or it can be connected to the covering 10 by means of sewing, gluing or other methods.

[0097] In some embodiments, the outer skirt 1001 can be an integral structure with the outer leak-proof membrane 10A. Of course, this integral structure can be formed by stitching, gluing, or molding to combine the outer skirt 1001 with the outer leak-proof membrane 10A.

[0098] In some embodiments, such as Figure 1 and Figure 26 As shown, by setting the extension rod 4, the outflow end of the artificial leaflet 9 cooperates with the extension rod 4 to form a longer axially closed section of the outflow end of the artificial leaflet 9, which increases the sealing between the artificial leaflets 9. Because the extension rod 4 is set on the upper side of the outflow end of the retainer 1, the outflow end of the artificial leaflet 9 is closer to the outflow end of the support 100 than the outflow end of the retainer 1. Thus, the closed section of the outflow end of the artificial leaflet 9 is also located closer to the outflow end of the support 100 than the outflow end of the retainer 1. The extension rod 4 effectively extends the axial length of the artificial leaflet 9, preventing the shortening of the axial length of the non-closed section of the artificial leaflet 9 due to the increase in the length of the closed section. Because an artificial leaflet 9 that is too short has relatively weak flexibility, making it relatively difficult to open and close the artificial leaflet 9, the axial growth of the closed section of the artificial leaflet 9 achieved by the extension rod 4 does not affect the axial length of the non-closed section of the artificial leaflet 9.

[0099] In some embodiments, the artificial leaflet 9 may comprise one or more synthetic materials, engineered biological tissue, bio-leaflet tissue, pericardial tissue, cross-linked pericardial tissue, aortic root tissue, chemically or biologically processed / treated tissue, or combinations thereof. In some embodiments, the pericardial tissue is selected from, but not limited to, tissues from cattle, horses, pigs, sheep, and humans, or combinations thereof.

[0100] In some embodiments, in order to facilitate better coordination between the support 100 and the conveying device for conveying, the outlet end of the positioning member 2 is fixedly connected to a connecting part 5, which is used to connect with the conveying system.

[0101] In some embodiments, such as Figure 1-2 As shown, in order to better cooperate with the conveying device for conveying, the connecting part 5 includes a connecting web 501 and a connecting block 502. The inflow end of the connecting web 501 is connected to the outflow end of the positioning member 2, and the outflow end of the connecting web 501 is connected to the connecting block 502. The circumferential width of the connecting block 502 is greater than the circumferential width of the connecting web 501. With such a design of the connecting part 5, it is easy to connect and separate the far end 300 of the conveying system from the outflow end of the support 100.

[0102] In some embodiments, such as Figure 33-36 As shown, when the stent 100 is implanted into the heart, the stent 100 and the delivery system 300 are placed into the sheath system 400, and then enter the heart through the sheath system 400. During the delivery process, the stent 100 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 away from the end operated by the user) includes an ear loop covering tube 301. A central catheter 304 is disposed inside the ear loop covering tube 301. The distal end of the central catheter 304 is provided with a groove 30401 that matches the connecting part 5 of the stent 100. The circumferential width of the outlet end of the connecting part 5 is greater than the circumferential width of the connecting web 501. The groove 30401, which matches the shape of the distal end of the central catheter 304, is such that the distal end of the groove 30401 can pass through the connecting web 501 but cannot pass through the connecting block 502, so that the connecting part 5 of the stent 100 can be stably confined in the groove 30401 in the axial direction. Figure 35 As shown. The ear loop covering tube 301 surrounds the central guide tube 304, preventing the connecting part 5 of the bracket 100 from popping out of the groove 30401, and also keeping the outlet end of the bracket 100 in a compressed state. An inner guide tube 302 is provided inside the central guide tube 304, passing through the interior of the bracket 100. A sleeve 303 is connected to the distal end of the inner guide tube 302. The sleeve 303 is located outside the distal portion of the inner guide tube 302, and a gap is left between the sleeve 303 and the inner guide tube 302 for mounting the bracket 100. It should be noted that, as Figure 33 As shown, only the anchoring part 8 of the support 100 is gathered inside the sleeve 303, i.e., in the gap between the sleeve 303 and the inner guide tube 302. The positioning member 2 and the reinforcing member 3 are gathered together by the sheath system 400 to ensure that the inflow end of the support 100 is in a compressed state and is ultimately transported in a compressed state.

[0103] Once the support 100 reaches the designated position, the release of the support 100 begins. First, the sheath system 400 is retracted. It should be noted that because the inner wall of the sheath system 400 is smooth, and the distal ends of the positioning member 2 and the reinforcing member 3 are also flat, the sliding conveying operation can be completed smoothly. During the retraction of the sheath system 400, the positioning member 2 and the reinforcing member 3 gradually extend. When the sheath system 400 has retracted a certain distance, the positioning member 2 and the reinforcing member 3 will lose their circumferential restraint, thus springing outwards to form a... Figure 32 The state of the stent in the middle can then be used to capture the aortic native leaflet. After capturing the aortic native leaflet, the cannula 303 is pushed forward using the inner catheter 302, causing the anchoring part 8 to disengage from the gap between the cannula 303 and the inner catheter 302. Then, the loop cover tube 301 is pulled back, causing the connecting part 5 of the stent 100 to lose the circumferential binding force and pop out from the groove 30401. At this time, the outflow end of the stent 100 is separated from the distal end 300 of the delivery system, thus completing the release of the entire stent 100. Figure 36 The state shown is as follows. The delivery system 300 is then removed from the body, and the stent 100 will remain stably in the heart.

[0104] In some embodiments, such as Figures 37-38 As shown, during the conveying process, the support 100 is in a compressed state. The distal end 300 of the conveying system includes a lug-covered tube 301. A central guide tube 304 is disposed inside the lug-covered tube 301. The distal end of the central guide tube 304 has a groove 30401 that matches the connecting portion 5 of the support 100. The circumferential width of the outlet end of the connecting portion 5 is greater than the circumferential width of the connecting web 501. The groove 30401, matching the shape of the distal end of the central guide tube 304, allows passage through the connecting web 501 but not through the connecting block 502, thus ensuring the connection portion of the support 100... 5 can be stably confined within the groove 30401 in the axial direction, while the ear-covering tube 301 surrounds the central guide tube 304, preventing the connecting part 5 of the bracket 100 from popping out of the groove 30401. This also keeps the outlet end of the bracket 100 in a compressed state. An inner guide tube 302 is provided inside the central guide tube 304, passing through the interior of the bracket 100. A sleeve 303 is connected to the distal end of the inner guide tube 302, positioned outside the distal portion of the inner guide tube 302. A gap is left between the sleeve 303 and the inner guide tube 302 for mounting the bracket 100. It should be noted that, as... Figure 38 As shown, the sleeve 303 gathers the inflow end of the stent 100, including the inflow end of the positioning member 2 and the reinforcing member 3 and the anchoring part 8, together inside the sleeve 303, that is, in the gap between the sleeve 303 and the inner guide tube 302, thereby keeping the inflow end of the stent 100 in a compressed state, and finally transporting the stent 100 in a compressed state.

[0105] During stent 100 deployment, first push the inner catheter 302 and cannula 303 forward to release the positioning element 2 from the cannula 303. Alternatively, by pulling back the loop cover tube 301 and the middle catheter 304 together, the stent 100 can be moved backward to release the positioning element 2 from the cannula 303. Align the positioning element 2 with the aortic native leaflet and push the loop cover tube 301 and the middle catheter 304 (or the loop cover tube 301, the middle catheter 304, and the inner catheter 302) forward to allow the positioning element 2 to capture the native leaflet, i.e., insert the positioning element 2 into the aortic sinus. At this point, push the inner catheter 302 and cannula 303 forward again to completely release the inflow end of the stent 100. Release means that the inflow end of the stent 100 is completely detached from the cannula 303. Then, the loop cover tube 301 is pulled back or the middle catheter 304 is pushed forward, so that the connecting part 5 of the stent 100 or the groove 30401 of the middle catheter 304 is removed from the coverage of the loop cover tube 301. At this time, the connecting part 5 of the outflow end of the stent 100 has no radial expansion resistance. Under the expansion of the stent 100, the connecting part 5 pops out from the groove 30401, so that the outflow end of the stent 100 is detached from the distal end 300 of the delivery system, thus completing the complete release of the entire stent 100. After that, the delivery system is removed from the human body, and the stent 100 will remain stably in the heart.

[0106] In some embodiments, such as Figure 1 and Figure 15 As shown, the retaining member 1 has a reinforcing support 6 inside. The outflow end of the reinforcing support 6 is connected to the retaining member 1, and the inflow end of the reinforcing support 6 is connected to the anchoring part 8. The main function of the reinforcing support 6 is to increase the circumferential support force of the bracket 100 and to provide a fixing point for the film 10 of the bracket 100. Further, as... Figure 39 and Figure 40 As shown, the reinforcing support 6 can be composed of several single connecting rods without intersection, such as two connecting rods independently or four connecting rods independently (e.g., Figure 15 (As shown), it can also be formed by several intersecting links to create a diamond-shaped grid, and then the diamond-shaped grid forms a reinforcing support 6 (as shown). Figure 39 (as shown), or a combination of both (such as) Figure 40 As shown), furthermore, the reinforcing support 6 may have one or more connection points with the anchoring part 8.

[0107] In some embodiments, such as Figure 1 , Figure 15 , Figure 39 and Figure 40As shown, the inflow end of the retainer 1 is not connected to the anchoring part 8. The retainer 1 is connected to the anchoring part 8 through the reinforcing support part 6, so that the anchoring part 8 is not directly connected to the retainer 1. This makes the anchoring part 8 relatively flexible to the retainer 1 and improves its applicability. The main function of the reinforcing support part 6 is to connect the anchoring part 8 to the retainer 1, and also to increase the circumferential support force of the bracket 100, while providing a fixing point for the film 10 of the bracket 100.

[0108] In some embodiments, such as Figure 41 As shown, the human aortic primary leaflet is generally composed of three primary leaflets. The corresponding stent 100 includes three retainers 1 connected circumferentially, and three positioning members 2, so that each primary leaflet has a corresponding retainer 1 and positioning member 2 for clamping.

[0109] In addition, this stent 100 can be cut from a nickel-titanium tube, but it should be noted that the material used can be any material that can be implanted in the human body and is elastic.

[0110] The present invention has been described in detail above with reference to the accompanying drawings and embodiments. Those 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, and the scope of protection of the present invention shall be defined by the appended claims.

Claims

1. A backflow preventer for preventing leakage, comprising a plurality of retaining members, a plurality of positioning members, and an anchoring part, wherein a positioning member is correspondingly disposed on the upper side of one of the retaining members, the outflow end of the positioning member is fixedly connected to the outflow end of the retaining member, and the anchoring part is disposed on the inflow end of the retaining member, wherein the inflow end of the retaining member has a U-shaped structure, characterized in that, A leak-proof membrane is connected to the U-shaped structure of the retainer; the leak-proof membrane includes an inner leak-proof membrane, which covers the inside of the U-shaped structure of the retainer. The leak-proof membrane also includes an outer leak-proof membrane, which covers the outside of the U-shaped structure of the retainer; Wherein, the outflow end of the inner leak-proof membrane does not exceed the U-shaped structure of the inflow end of the retainer; the outflow end of the outer leak-proof membrane does not exceed the U-shaped structure of the inflow end of the retainer.

2. The anti-leakage backflow bracket as described in claim 1, characterized in that, The inflow end of the retainer is connected to the outflow end of the anchoring part, and the outer side of the inflow end of the anchoring part is covered with an outer skirt.

3. The anti-leakage backflow bracket as described in claim 2, characterized in that, The outer skirt is integrally connected to the outer leak-proof membrane.

4. The anti-leakage backflow bracket as described in claim 2, characterized in that, The inner side of the counterflow bracket is provided with a membrane covering the inflow end of the retainer to the anchoring part, and the membrane is connected to the outer skirt.

5. The anti-leakage backflow bracket as described in claim 4, characterized in that, The coating is connected to the outer skirt by stitching, gluing, or integral molding.

6. The anti-leakage backflow bracket as described in claim 1, characterized in that, The anchoring part of the counterflow bracket is provided with several barbs in the circumferential direction, and the barbs are inclined outward at 5°~15°.

7. The anti-leakage backflow bracket as described in claim 6, characterized in that, The anchoring part is formed by connecting several diamond-shaped grids laterally, and the inflow end of the barb is connected to the inflow end of the anchoring part.

8. The anti-leakage backflow bracket as described in claim 1, characterized in that, At least one of the positioning elements can control its opening angle relative to the support axis.

9. The anti-leakage backflow bracket as described in claim 8, characterized in that, The positioning component is controlled by a pull wire, and under the control of the pull wire, the positioning component can open at an angle of 20° to 60° relative to the axis of the support.

10. The anti-leakage backflow bracket as described in claim 8, characterized in that, The positioning component is controlled by a pull wire, and under the control of the pull wire, the positioning component can open at an angle of 60° to 90° relative to the axis of the support.

11. The anti-leakage backflow bracket as described in any one of claims 8-10, characterized in that, The inflow end of the positioning component is provided with a pull-wire hole.

12. The anti-leakage backflow bracket as described in claim 8, characterized in that, The positioning element and the retaining element have cooperative shapes that hold the original leaflet of the heart valve between the positioning element and the retaining element.

13. The anti-leakage backflow bracket as described in claim 8, characterized in that, A reinforcing member is provided in the middle of the positioning member, and the two ends of the reinforcing member are respectively connected to the inner sides of the two sides of the positioning member.

14. The anti-leakage backflow bracket as described in claim 8, characterized in that, The outlet end of the positioning member and the outlet end of the retaining member are fixedly connected by an extension rod.

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