Aortic regurgitation stent with easily bendable positioning part

Abstract

The present application discloses an aortic regurgitation stent with an easily bendable positioning member, which relates to the field of medical device technology, and comprises a plurality of retaining members, a plurality of positioning members and an anchoring portion, wherein a positioning member is correspondingly arranged 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 inflow end of the retaining member is provided with an anchoring portion; wherein, the outflow end of the positioning member is a wavy curved rod structure, which is beneficial for the positioning member to capture the native valve leaflet without the need to move and adjust the stent horizontally, thereby reducing the difficulty of the operation; by setting the outflow end of the positioning member to a wavy curved rod structure, the stability of the positioning member in clamping the native valve leaflet is increased, the deformation amplitude of the connection at the outflow end of the positioning member is reduced, and the damage of the inflow end of the positioning member to the aortic sinus bottom is reduced; the anti-wear strip is set to reduce the tearing force of the suture line directly on the artificial valve leaflet, thereby improving the service life of the artificial heart valve and facilitating the long-term operation of the artificial heart valve in the human body.

Description

[0001] This application claims the benefit of Chinese patent application No. 2022103159315, filed on March 28, 2022. This application incorporates the entirety of the aforementioned Chinese patent application. Technical Field

[0002] The present application relates to the technical field of medical devices, and in particular to an aortic regurgitation stent with a flexible positioning member. Background Art

[0003] Due to the advantages of transcatheter surgery, such as minimal trauma and rapid recovery, more and more surgeries are being performed using transcatheter surgery. Aortic valve replacement has also evolved from an early surgical procedure to a transcatheter approach.

[0004] The Chinese invention patent with authorization announcement number CN102413793B and titled "Stent for positioning and anchoring the implantation site of a valve prosthesis in the patient's heart" discloses an expandable stent. During the implantation process, it is necessary to align multiple positioning arcs with multiple native aortic valve leaflets and insert the positioning arc into the aortic sinus. The number of heart beats in a person's lifetime can be as many as 2 billion times. After the native aortic valve is replaced by an artificial heart valve, during the diastole (left ventricular diastole), the artificial heart valve needs to withstand the impact of blood flow from the aorta. At this time, the positioning arc is inserted into the aortic sinus. The inflow end of the positioning arc will impact the aortic sinus bottom multiple times, and the positioning arc without a buffer structure will rigidly impact the aortic sinus bottom, which may easily cause damage to the aortic sinus bottom. Secondly, during the implantation of the stent, since the positioning arc is a relatively straight structure, the flexibility of the positioning arc is relatively poor. During the implantation of the positioning arc, deformation mainly occurs at the connection between the positioning arc and the stent. For example, the native valve leaflet presses against the positioning arc, and the force deformation of the positioning arc mainly depends on the connection between the positioning arc and the stent, which may easily cause excessive deformation stress at the connection between the positioning arc and the stent and damage the stent.

[0005] To this end, it is necessary to provide a heart valve stent (regurgitation stent) that can be used for transcatheter aortic valve replacement and has a relatively flexible positioning arc (piece). Summary of the Invention

[0006] In view of the problem that the positioning arc in the prior art is not flexible enough, the present application provides an aortic regurgitation stent with an easily bendable positioning member, thereby solving the problem that the positioning arc of the regurgitation stent is not flexible enough.

[0007] To achieve the above objectives, this application provides the following technical solutions:

[0008] An aortic regurgitation stent with a flexible positioning member, comprising a plurality of retaining members, a plurality of positioning members, and an anchoring portion, wherein a positioning member is provided on the upper side of each retaining 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;

[0009] Wherein, the outflow end of the positioning member is a wavy curved rod structure.

[0010] Preferably, the wavy curved rod structure is formed by alternating transverse U-shaped structural rods.

[0011] Preferably, at least one of the positioning members is controlled by a pull wire, and under the control of the pull wire, the positioning member can be opened to an angle ranging from 20° to 90° relative to the axis of the bracket.

[0012] Preferably, a wire drawing compound ring is provided on the inner side of the inflow end of the positioning member, a wire drawing hole is provided on the outflow end of the wire drawing compound ring, and the inflow end portion of the wire drawing compound ring is used for development.

[0013] Preferably, the wire drawing composite ring includes a connecting rod and a wire drawing ring, the inflow end of the connecting rod is fixedly connected to the inflow end of the positioning member, the outflow end of the connecting rod is fixedly connected to the wire drawing ring, and the wire drawing ring is provided with a wire drawing hole.

[0014] Preferably, the positioning member and the retaining member have cooperative shapes to retain the native leaflets of the heart valve between the positioning member and the retaining member.

[0015] Preferably, the diameter of the circle (O1) where the edges on both sides of the inflow end of the positioning member are located is smaller than the diameter of the circle (O2) where the edges of the middle parts on both sides of the inflow end of the positioning member are located.

[0016] Preferably, the outflow end of the positioning member is fixedly connected to the outflow end of the retaining member through an extension rod, and a leaflet suture hole is provided inside the extension rod. The leaflet suture hole is used to fix the outflow end of the artificial leaflet, and the outflow end of the artificial leaflet is closer to the outflow end of the stent than the outflow end of the retaining member.

[0017] Preferably, the artificial valve leaflet includes an artificial valve leaflet main body and an artificial valve leaflet ear arranged at the outflow end of the artificial valve leaflet main body, the artificial valve leaflet ear passes through the valve leaflet suture hole to wrap the extension rod, the edge of the inflow end of the artificial valve leaflet main body is connected to the coating, the coating is installed on the inner side of the bracket, and the outflow end of the coating is connected to the retaining member, the inflow end of the coating is connected to the anchoring part, and an anti-wear strip is provided at the connection between the edge of the inflow end of the artificial valve leaflet main body and the coating, the anti-wear strip is a folded structure, the cross-section of the anti-wear strip is a U-shaped structure, and the edge of the inflow end of the artificial valve leaflet main body is arranged inside the folded anti-wear strip.

[0018] Preferably, the folded portion of the anti-wear strip is provided with 3 to 10 stress notches.

[0019] Preferably, the inflow end of the coating is turned outward from the inside of the stent to the outside of the stent to form an outer skirt of the anchoring portion.

[0020] Preferably, the outflow end of the positioning member is fixedly connected with a connecting portion, and the connecting portion is used to connect to the conveying system. The connecting portion includes a connecting web, the inflow end of the connecting web is connected to the outflow end of the positioning member, and the outflow end of the connecting web is connected to a connecting block, and the circumferential width of the connecting block is greater than the circumferential width of the connecting web.

[0021] Preferably, the inflow end portion of the retaining member presents a teardrop-shaped structure in a compressed state, the inflow end portion of the retaining member presents a U-shaped structure in an expanded state, and the inflow end portion of the positioning member presents a teardrop-shaped structure in a compressed state.

[0022] Preferably, the inflow end of the retaining member is fixedly connected to the anchoring portion, a reinforcing support portion is provided inside the retaining member, the outflow end of the reinforcing support portion is connected to the retaining member, and the inflow end of the reinforcing support portion is connected to the anchoring portion.

[0023] Preferably, the inflow end of the retaining member is not connected to the anchoring portion, and the retaining member is connected to the anchoring portion via a reinforcing support portion.

[0024] Preferably, the anchoring portion is formed by connecting circumferentially connected diamond grids, and the diameter of the outflow end of the anchoring portion is smaller than the diameter of the inflow end of the anchoring portion.

[0025] Preferably, the bracket includes three circumferentially connected retaining members.

[0026] Compared with the prior art, the present application provides an aortic regurgitation stent with a flexible positioning member, which has the following beneficial effects:

[0027] 1. The opening angle of the positioning member can be controlled by a pull wire: During the transcatheter regurgitation stent implantation process, the positioning member needs to be used to capture the native leaflet, that is, the positioning member needs to be inserted into the non-closed surface of the native leaflet, and the retaining member is located on the closed surface of the native leaflet to clamp the native leaflet. However, since the aortic valve leaflet is generally composed of three native leaflets, the positioning member can easily capture two of them when capturing all the native leaflets, but it is relatively difficult to capture three native leaflets at a time, because the three native leaflets are surrounded in a circle, and each native leaflet is adjacent and difficult to adjust. In addition, the native leaflets are movable, so it is relatively difficult to capture three native leaflets at a time. In the regurgitation stent of the present application, at least one of the positioning members can control the opening angle. Here, a pull wire can be used to control the opening angle of the positioning member and the axis of the stent. The pull wire is used to open the positioning member to a larger angle, making it easier to approach the non-closed surface of the native leaflet, thereby facilitating the positioning member to capture the native leaflet without the need to move and adjust the stent horizontally, saving operation time and reducing surgical difficulty.

[0028] 2. The outflow end of the positioning piece is set as a wavy curved rod structure: when the positioning piece clamps the native valve leaflet, the outflow end of the positioning piece corresponds to the outflow end of the native valve leaflet. The curved structure increases the contact area between the positioning piece and the native valve leaflet, effectively increasing the stability of the positioning piece in clamping the native valve leaflet. Secondly, when the pull wire is used to control the positioning piece to open at a larger angle, the deformation of the positioning piece can be bent open by the curved structural part, reducing the deformation amplitude of the connection at the outflow end of the positioning piece and reducing the damage that may be caused by its deformation stress. Finally, the curved structure also makes the positioning piece have a certain elasticity in the axial direction. When blocking blood reflux during cardiac diastole, it can buffer the impact of blood reflux and reduce the damage of the inflow end of the positioning piece to the aortic sinus bottom.

[0029] 3. The artificial valve leaflet and the covering are connected by setting the anti-wear strip as a folding structure: the edge of the inflow end of the artificial valve leaflet body is set inside the folded anti-wear strip, and the edge of the artificial valve leaflet body is completely wrapped, which effectively increases the tear resistance of the edge of the artificial valve leaflet body. Moreover, when using sutures to fix the artificial valve leaflet and the covering, compared with the traditional anti-wear strip that is only located between the artificial valve leaflet and the covering, the force generated by the suture on the inner side of the artificial valve leaflet (close to the axis direction of the stent) will directly act on the artificial valve leaflet. Therefore, the force generated by the suture on the inner side of the artificial valve leaflet (close to the axis direction of the stent) can easily damage the artificial valve leaflet. The folded, U-shaped anti-wear strip completely wraps the edge of the artificial valve leaflet body, and the force generated by the suture acts completely on the anti-wear strip, reducing the direct tearing force of the suture on the artificial valve leaflet, thereby improving the service life of the artificial heart valve and facilitating the long-term operation of the artificial heart valve in the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The specific features of the inventions of this application are set forth in the appended claims. The features and advantages of the inventions of this application can be better understood by referring to the exemplary embodiments described in detail below and the accompanying drawings. A brief description of the drawings is as follows:

[0031] Figure 1 This is a schematic structural diagram of a reflux stent and a marker "marker" according to an embodiment of the present application;

[0032] Figure 2 for Figure 1 Expanded view of the reflux stent in [ 1 ];

[0033] Figure 3 for Figure 2 A partial magnified view in ;

[0034] Figure 4 This is a front view of a reflux stent according to another embodiment of the present application;

[0035] Figure 5 for Figure 4 Schematic diagram of the structure of the mid-reflux stent;

[0036] Figure 6 for Figure 4 Schematic diagram of the structure of the mid-reflux stent and C-shaped piece;

[0037] Figure 7 for Figure 6 A partial magnified view in ;

[0038] Figure 8 It is a structural diagram of the C-type component;

[0039] Figure 9 for Figure 4 Expanded view of the reflux stent in [ 1 ];

[0040] Figure 10 for Figure 9 A partial magnified view in ;

[0041] Figure 11 for Figure 10 A partial magnified view in ;

[0042] Figure 12 This is a schematic diagram of the structure of a reflux stent according to another embodiment of the present application;

[0043] Figure 13 for Figure 12 A partial magnified view in ;

[0044] Figure 14 for Figure 12 Expanded view of the reflux stent in [ 1 ];

[0045] Figure 15 This is a schematic diagram of the structure of a reflux stent according to another embodiment of the present application;

[0046] Figure 16 for Figure 15 A partial magnified view of the ;

[0047] Figure 17 for Figure 15 Expanded view of the reflux stent in [ 1 ];

[0048] Figure 18 This is a schematic diagram of the structure of a reflux stent according to another embodiment of the present application;

[0049] Figure 19 for Figure 18 Expanded view of the reflux stent in [ 1 ];

[0050] Figure 20 This is an expanded view of a reflux stent according to another embodiment of the present application;

[0051] Figure 21 This is an expanded view of a reflux stent according to another embodiment of the present application;

[0052] Figure 22 This is a schematic structural diagram of a compressed state of a reflux stent according to another embodiment of the present application;

[0053] Figure 23 for Figure 22 A partial magnified view of the ;

[0054] Figure 24 Schematic diagram of the structure of the artificial valve leaflet and the anti-wear strip in this application;

[0055] Figure 25 This is an expanded view of the wear strip in this application;

[0056] Figure 26 This is a schematic diagram of an artificial valve leaflet, anti-wear strip and covering structure in this application;

[0057] Figure 27 This is a schematic diagram of another artificial valve leaflet, anti-wear strip and covering structure in this application;

[0058] Figure 28 Schematic diagram of the structure of the reflux stent, graft, and artificial valve leaflet in this application;

[0059] Figure 29 This is a schematic diagram of the structure of the reflux stent, membrane, artificial valve leaflet, and outer skirt in this application;

[0060] Figure 30 A schematic diagram of the positioning element of the anti-flow stent in the present application being opened to align with the native aortic valve leaflet in preparation for capture;

[0061] Figure 31 A schematic diagram of the positioning element of the anti-flow stent in the present application being aligned with the native aortic valve leaflet and inserted into the aortic sinus;

[0062] Figure 32 This is a schematic diagram of the structure of the distal part of the delivery system in this application;

[0063] Figure 33 This is a schematic diagram of the structure of the delivery system in this application without the outer catheter at the distal end;

[0064] Figure 34 Schematic diagram of the native aortic valve leaflets.

[0065] Description of reference numerals:

[0066] 100, stent, 300, distal end of delivery system, 301, outer catheter, 302, inner catheter, 303, sleeve, 304, middle catheter, 30401, groove, 1, retaining member, 2, positioning member, 201, wavy curved rod structure, 3, reinforcement member, 4, extension rod, 401, leaflet suture hole, 5, connecting part, 501, connecting web, 502, connecting block, 6, strengthening support part, 7, pull wire composite ring, 701, pull wire ring, 702, connecting rod, 70 3. C-shaped part, 70301. C-shaped outer wall, 70302. C-shaped two side walls, 7C. Pull wire composite ring, 7C01. Marking embedded hole, 77. Pull wire hole, 8. Anchoring part, 9. Artificial valve leaflet, 901. Artificial valve leaflet main body, 902. Artificial valve leaflet ear, 10. Cover, 1001. Outer skirt, 11. Anti-wear strip, 1101. Stress notch, 1102. Folding line, 11', traditional anti-wear strip, 1000. Inflow end, 2000. Outflow end. DETAILED DESCRIPTION

[0067] The following describes the embodiments of the present application through specific examples. Those skilled in the art can easily understand the other advantages and effects of the present application from the content disclosed in this specification. The present application can also be implemented or applied through other different specific embodiments. The details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present application. It should be noted that the following embodiments and features in the embodiments can be combined with each other unless they conflict.

[0068] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a..." does not exclude the presence of additional identical elements in the process, method, article, or device comprising the element.

[0069] It should be noted that, in this article, the height direction is substantially along the direction of the axis of the artificial heart valve. Except for the specific description shown in the figure, the high, low, upper, lower, etc. directly mentioned in this article refer to the height direction when the valve is close to the expanded state (such as Figure 1 The position of the outflow end of the artificial heart valve is shown in the figure. The "lower" and "lower" refer to the position close to the inflow end of the artificial heart valve when it is in the expanded state. The "inflow end" refers to the position upstream in the direction of blood flow, that is, the end of the stent that first passes through the blood when it is in the expanded state. Figure 4 The inflow end 1000 shown in FIG. 1 is a “outflow end”, which 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. Figure 4 Outflow end 2000 is shown.

[0070] The present application provides a technical solution: an aortic regurgitation stent with a flexible positioning member, comprising a plurality of retaining members 1, a plurality of positioning members 2, and an anchoring portion 8. A positioning member is provided on the upper side of each retaining member, the outflow end of the positioning member 2 is fixedly connected to the outflow end of the retaining member 1, and the inflow end of the retaining member 1 is provided with the anchoring portion 8. The positioning member 2 and the retaining member 1 are used to clamp the native valve leaflet, and then the anchoring portion 8 is used to clamp the aortic valve ring, so that the regurgitation stent is stably located at the native aortic valve position.

[0071] like Figure 12-14As shown, the outflow end of the positioning member 2 is a wavy curved rod structure 201. There are three significant advantages brought about by this arrangement. First, when the positioning member 2 clamps the native leaflet, the outflow end of the positioning member 2 corresponds to the outflow end of the native leaflet, that is, the free end of the native leaflet. The wavy curved rod structure 201 increases the contact area between the positioning member 2 and the native leaflet, effectively increasing the stability of the positioning member 2 in clamping the native leaflet. Secondly, when the pull wire is used to control the positioning member 2 to open a larger angle, the deformation of the positioning member 2 can be partially bent by the wavy curved rod structure 201 to open the positioning member 2, reducing the deformation amplitude of the connection at the outflow end of the positioning member 2 and reducing the damage to the connection at the outflow end of the positioning member 2 that may be caused by its deformation stress. Finally, the wavy curved rod structure 201 also makes the positioning member 2 have a certain elasticity in the axial direction. When blocking blood reflux during cardiac diastole, it can buffer the impact force of blood reflux and reduce the damage of the inflow end of the positioning member 2 to the aortic sinus bottom.

[0072] In some embodiments, as Figure 15-17 As shown, in order to further increase the elasticity of the positioning member 2 in the axial direction, the bending amplitude of the wavy curved rod structure 201 is relatively large, such as S-shaped, or the wavy curved rod structure 201 formed by alternating transverse U-shaped structural rods can effectively increase the elasticity of the positioning member 2 in the axial direction.

[0073] In some embodiments, during the transcatheter reflux stent implantation process, it is necessary to use the positioning member 2 to capture the native leaflet, that is, the positioning member 2 is inserted into the non-closed surface of the native leaflet, and the retaining member 1 is located on the closed surface of the native leaflet, so that the retaining member 1 and the positioning member 2 clamp the native leaflet. However, since the native aortic leaflet is generally composed of three native leaflets (such as Figure 34 As shown), there are generally at least three positioning members 2, corresponding to all the native leaflets that need to be captured. It is relatively easy for the positioning member 2 to capture two of the native leaflets, but it is relatively difficult to capture three native leaflets at a time, because the three native leaflets form a circle. When the positioning member 2 is aligned with the native leaflets, when the stent 100 is moved horizontally (perpendicular to the axis of the stent 100), there must be a non-closed surface of the native leaflets that the positioning member 2 moves away from and approaches, and the native leaflets are also active under the action of blood, so the timing of capture is also very important. Therefore, it is relatively difficult for all positioning members 2 to capture three native leaflets at a time, resulting in the operation time being extended due to the inability to capture the three native leaflets. Therefore, in order to better capture the native leaflets, the opening angle of at least one of the positioning members 2 is controlled. Here, a pull wire can be used to control the opening angle of the positioning member 2 and the axis of the stent 100. The pull wire is used to open the positioning member 2 to a larger angle, making it easier to approach the non-closed surface of the native leaflets, thereby facilitating the positioning member 2 to capture the native leaflets without the need to move and adjust the stent 100 horizontally;

[0074] Here, at least one of the positioning members 2 is controlled by a pull wire. Under the control of the pull wire, the positioning member 2 can be opened at an angle of 20° to 60° relative to the axis of the stent 100, for example, 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 native leaflet, there is no need to horizontally move the stent 100. By opening the positioning member 2 at a larger angle, a larger radial outward dimension can be obtained, and the positioning member 2 can be aligned with the non-closed surface of the native leaflet, so that the positioning member 2 of the stent 100 can smoothly capture the native leaflet.

[0075] Furthermore, the positioning member 2 can be opened to an angle of 60° to 90° relative to the axis of the stent 100 under the control of the pull wire. The larger angle, for example, close to 90°, is used to provide a remedy after the positioning member 2 fails to capture the native leaflet, that is, although the positioning member 2 is opened to a larger angle (such as 90°) before capturing the native leaflet by the pull wire, the positioning member 2 can still be opened to a larger angle (such as 90°) before capturing the native leaflet. Figure 30 As shown) to facilitate the capture of the native leaflet, and then push the positioning member 2 into the non-closed surface of the native leaflet (as shown Figure 31 As shown in the figure, the stent 100 is about to be moved toward the ventricle, but due to reasons such as: the native leaflet moves during the pushing process of the positioning member 2, the imaging equipment has a bad angle, the imaging is not clear, etc., which lead to observation errors, the positioning member 2 fails to be successfully inserted into the non-closed surface of the native leaflet. The traditional stent 100 that cannot control the opening angle of the positioning member 2 can only retreat the stent 100, that is, withdraw the positioning member 2 from the non-closed surface of the native leaflet and re-capture the native leaflet. Now the positioning member 2 can open a larger angle, such as 75°, 76°, 77°, 78°, 79°, 80°, 81°, 82°, 83°, 84°, 85°, 86°, 87°, 88°, 89°, 90°. Without retreating the stent 100, the non-closed surface of the native leaflet will be The inflow end of the positioning member 2 on the non-closed surface of the native leaflet is opened to a position higher than the outflow end of the uncaught native leaflet, and then the positioning member 2 is lowered to achieve 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 member 2. Although the inflow end of the positioning member 2 may touch the aortic wall, its duration is short, that is, it will no longer open in the later stage, and the inflow end of the positioning member 2 will no longer touch the aortic wall, and it is opened when the stent 100 is in a compressed state, that is, opening the positioning member 2 in the compressed state of the stent 100 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 member 2 can be opened to a relatively large angle under the control of the pull wire to perform secondary capture of the native leaflet.

[0076] In some embodiments, as Figure 1-3 As shown, a wire 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 as a whole, its concave side (i.e., the upper side) is its inner side. Obviously, the position of the wire composite ring 7C is as shown in FIG. Figure 1-Figure 3 It is also clearly shown in the figure that since the positioning member 2 needs to capture the native leaflet, the position of the inflow end of the positioning member 2 is particularly important. In order to clearly display the position of the inflow end of the positioning member 2 on the imaging device, the inflow end of the pull-wire composite ring 7C is used for imaging. The embodiment given here is to open a marking embedding hole 7C01 at the inflow end of the pull-wire composite ring 7C, and embed a marking member "marker" (the marking member "marker" is non-radiopaque) in the marking embedding hole 7C01, so that the positioning member 2 can accurately locate the implant. The positioning member 2 is inserted into the sac to ensure that the positioning member 2 can accurately capture the native leaflet and insert it into the sinus bottom, and the outflow end of the pull wire composite ring 7C is provided with a pull wire hole 77, and the pull wire hole 77 is used to pass 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 77, so that the positioning member 2 can capture the native leaflet and reduce the difficulty of operation. At the same time, the pull wire composite ring 7C structure provided at the inflow end of the positioning member 2 combines the pull wire control and the development function into one position (pull wire composite ring 7C), which effectively improves the space utilization of the product. It should be noted here that, although in the case of Figure 1-Figure 3 The middle pull wire composite ring 7C is in the shape of a gourd, but its shape includes but is not limited to the shape of a gourd. The pull wire composite ring 7C can be rectangular, triangular, elliptical and other shapes, and adopting a specific shape can also make it have the function of auxiliary identification, such as presenting a gourd shape, rectangle, triangle, elliptical and other shapes in the imaging device, which is more conducive to observation.

[0077] In some embodiments, as Figure 4-8 As shown, by pulling the wire composite ring 7C (as Figure 1 As shown in FIG. 1 , the inflow end of the positioning member 2 is opened to mark the embedded hole 7C01 and the marker "marker" is embedded. Although such a setting can realize the observation and positioning of the inflow end of the positioning member 2, it is also limited by the wire composite ring 7C (as shown in FIG. Figure 1As shown in the figure, the size of the inflow end marker embedded hole 7C01 is limited, resulting in a smaller volume of the marker "marker", which is not conducive to observation during development or the smaller volume of the marker "marker" makes it more difficult to observe. In order to increase 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, and a C-shaped member 703 is installed on the connecting rod 702. The C-shaped member 703 is made of non-radiopaque metal and can present a clear image under the imaging device. Moreover, since the C-shaped member 703 is wrapped on the connecting rod 702, as shown in the figure, Figure 8 As shown, the C-shaped part 703 is a part with a cross section similar to a C-shape, and the opening of the C can be opened and closed, and is used to be installed on the connecting rod 702. Here, the side of the C-shaped part 703 away from the axial direction of the bracket 100 is the C-shaped outer wall 70301, and the side walls clamped on both sides of the circumferential direction of the connecting rod 702 are the C-shaped side walls 70302. In order to reduce the unevenness of the outer surface of the wire composite ring 7 caused by the C-shaped part 703, the thickness of the C-shaped outer wall 70301 is less than the thickness of the C-shaped side walls 70302. Since the C-shaped part 703 is wrapped on the connecting rod 702, the volume of the C-shaped part 703 is relatively The larger the size, the easier it is to observe, and the lower 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 wire pull ring 701. The maximum outline size of the wire pull ring 701 here is larger than the width (circumferential) size of the connecting rod 702, thereby preventing the C-shaped member 703 from sliding 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 wire pull ring 701. The wire pull ring 701 is provided with a wire pull hole 77, and the wire pull hole 77 is used to pass the wire through which the positioning member 2 is controlled to open to a larger angle.

[0078] In some embodiments, in order to better enable the stent 100 to clamp the native leaflets, the positioning member 2 and the retaining member 1 have a cooperative shape, that is, 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.

[0079] In some embodiments, as Figures 9-11As shown, since the positioning member 2 needs to be inserted into the bottom of the aortic sinus, during the diastole of the heart, that is, the left ventricle is in the diastolic state, the aortic valve (artificial heart valve / stent 100) is closed to prevent blood from flowing back from the aorta to the heart, so the artificial heart valve needs to withstand a certain reverse pressure to prevent blood from flowing back. Since the positioning member 2 is inserted into the aortic sinus, the inflow end of the positioning member 2 will press down the bottom of the aortic sinus. In order to prevent the positioning member 2 from puncturing the aortic sinus, the inflow end of the positioning member 2 is made relatively flat to increase the contact area between the inflow end of the positioning member 2 and the bottom of the aortic sinus. Therefore, the diameter of the circle (O1) where the edges on both sides of the inflow end of the positioning member 2 are located is smaller than the diameter of the circle (O2) where the edges of the middle part of the inflow end of the positioning member 2 are located. Furthermore, the inflow end of the positioning member 2 can also be wrapped, for example, the inflow end of the positioning member 2 is wrapped with the same material as the artificial valve leaflet 9 to form a relatively soft inflow end of the positioning member 2.

[0080] In some embodiments, a reinforcement member 3 is provided in the middle of the positioning member 2. The provision of the reinforcement member 3 effectively increases the contact area between the positioning member 2 and the native leaflet. The two ends of the reinforcement member 3 are respectively connected to the inner sides of the two sides of the positioning member 2. In this embodiment, the reinforcement member 3 is a V-shaped structure, which can realize the compression and expansion of the reinforcement member 3. The connection between the two ends of the reinforcement member 3 and the positioning member 2 is relatively close to the outflow end of the positioning member 2, which also effectively increases the circumferential support force of the outflow end of the positioning member 2, thereby increasing the stability of the entire stent 100.

[0081] In some embodiments, since each person is an individual and thus the aortic valve may have slight differences, the outflow end of the positioning member 2 is fixedly connected to the outflow end of the retaining member 1 via an extension rod 4, thereby increasing the ability of the positioning member 2 to adjust relative to the retaining member 1. This also allows the length of the entire stent 100 to be adjusted to a certain extent, making it suitable for a wider range of people.

[0082] Furthermore, in order to improve the closing performance of the outflow end of the artificial valve leaflet 9, a valve leaflet suture hole 401 is provided inside the extension rod 4. The valve leaflet suture hole 401 is used to fix the outflow end of the artificial valve leaflet 9. The outflow ends of adjacent artificial valve leaflets 9 are tightly combined and pressed together through the valve leaflet suture hole 401, effectively preventing blood from flowing back through the closed part of the outflow end of the artificial valve leaflet 9. Figure 28As shown, by the arrangement of the extension rod 4, the outflow end of the artificial valve leaflet 9 cooperates with the extension rod 4 to form a closed interval of the outflow end of the artificial valve leaflet 9 that is longer in the axial direction, thereby increasing the sealing between the artificial valve leaflets 9. Because the extension rod 4 is arranged on the upper side of the outflow end of the retaining member 1, the outflow end of the artificial valve leaflet 9 is closer to the outflow end of the stent 100 than the outflow end of the retaining member 1, thereby also making the closed interval of the outflow end of the artificial valve leaflet 9 formed closer to the outflow end of the stent 100 than the outflow end of the retaining member 1. The extension rod 4 is effectively utilized to extend the axial length of the artificial valve leaflet 9, thereby preventing the axial length of the non-closed interval of the artificial valve leaflet 9 from being shortened due to the increase in the length of the closed interval of the artificial valve leaflet 9. Because the flexibility of an artificial valve leaflet 9 that is too short is relatively weak, it is relatively difficult for the artificial valve leaflet 9 to open and close. The axial growth of the closed interval of the outflow end of the artificial valve leaflet 9 is achieved by extending the rod 4, and the axial length of the non-closed interval of the artificial valve leaflet 9 is not affected.

[0083] In some embodiments, as Figure 24-29 As shown, the artificial valve leaflet 9 includes an artificial valve leaflet main body 901 and an artificial valve leaflet ear 902 arranged at the outflow end of the artificial valve leaflet main body 901, the artificial valve leaflet ear 902 passes through the valve leaflet suture hole 401 and wraps the extension rod 4, the edge of the inflow end of the artificial valve leaflet main body 901 is connected to the membrane 10, the membrane 10 is installed on the inner side of the bracket 100, and the outflow end of the membrane 10 is connected to the retaining member 1, the inflow end of the membrane 10 is connected to the anchoring part 8, and an anti-wear strip 11 is provided at the connection between the edge of the inflow end of the artificial valve leaflet main body 901 and the membrane 10. The setting of the anti-wear strip 11 first increases the tear resistance of the inflow end of the artificial valve leaflet 9, and secondly reduces the damage to the artificial valve leaflet 9 caused by the friction between the inflow end of the artificial valve leaflet 9 and the membrane 10, thereby improving the artificial valve leaflet 9. The service life of the artificial valve leaflet 9 is prolonged, and the setting of the anti-wear strip 11 is equivalent to a buffer layer between the artificial valve leaflet 9 and the coating 10, which effectively buffers the tearing force of the artificial valve leaflet 9 on the coating 10 during the opening and closing process, thereby increasing the service life of the artificial heart valve; further, the anti-wear strip 11 is designed as follows: the anti-wear strip 11 is a folded structure, that is, the cross section of the anti-wear strip 11 is a U-shaped structure, and the inflow end edge of the artificial valve leaflet body 901 is arranged inside the folded anti-wear strip 11, which completely wraps the edge of the artificial valve leaflet body 901, effectively increasing the tear resistance of the edge of the artificial valve leaflet body 901, and when using sutures to fix the artificial valve leaflet 9 and the coating 10, compared with the use of traditional anti-wear strips 11' (such as Figure 26As shown), the traditional anti-wear strip 11' is only located between the artificial valve leaflet 9 and the membrane 10. Therefore, the force generated by the suture line on the inner side of the artificial valve leaflet 9 (close to the axial direction of the stent 100) will directly act on the artificial valve leaflet 9. When the artificial valve leaflet 9 is subjected to the impact of blood, the connection between the artificial valve leaflet main body 901 and the membrane 10 will definitely be torn to a certain extent. Therefore, the force generated by the suture line on the inner side of the artificial valve leaflet 9 (close to the axial direction of the stent 100) can easily damage the artificial valve leaflet 9, causing the artificial valve leaflet 9 to fail, and then the entire artificial heart valve fails (but it should be noted here that in this application, the connection between the membrane 10 and the artificial valve leaflet 9 can be but is not limited to the traditional anti-wear strip 11'), and the folded, U-shaped anti-wear strip 11 completely wraps the edge of the entire artificial valve leaflet main body 901, and the force generated by the suture line completely acts on the anti-wear strip 11, which reduces the direct tearing force of the suture line on the artificial valve leaflet 9, improves the service life of the artificial heart valve, and is beneficial to the long-term work of the artificial heart valve in the human body.

[0084] In some embodiments, as Figure 25 As shown, since the edge of the artificial valve leaflet 9 is curved, when the anti-wear strip 11 is folded, material extrusion and overlapping will occur. In order to solve this phenomenon, the folding part of the anti-wear strip 11 is provided with 3 to 10 stress notches 1101, thereby reducing the phenomenon of material extrusion and overlapping when the anti-wear strip 11 is folded. Here, the stress notch 1101 can be provided on the outside of the folding line 1102 or on the inside of the folding line 1102. Furthermore, the material of the anti-wear strip 11 on both sides of the folding line 1102 can be an integral structure, or it can be formed by connecting different materials at the folding line 1102 through suturing, gluing, etc.

[0085] In some embodiments, in order to reduce the friction damage between the anti-wear strip 11 and the artificial valve leaflet 9, and to ensure that the anti-wear strip 11 and the artificial valve leaflet 9 have the same mechanical properties as much as possible, to ensure that the artificial valve leaflet 9 has better opening and closing stability, the anti-wear strip 11 and the artificial valve leaflet 9 are made of the same material.

[0086] In some embodiments, as Figure 29As shown, since the outer side of the anchoring portion 8 (away from the axial direction of the stent 100) needs to be in contact with the aortic valve ring to limit the displacement of the stent 100 in the axial direction away from the left ventricle, the anchoring portion 8 will often be in contact with the aortic valve ring. In order to reduce the damage to the valve caused by the exposed anchoring portion 8 of the stent 100, the inflow end of the coating 10 is turned outward from the inside of the stent 100 to the outside of the stent 100 to form an outer skirt 1001 of the anchoring portion 8. Furthermore, the outer skirt 1001 can be made of a strong and durable material, such as woven PET laser cut or otherwise formed, or other synthetic or natural materials can be used. The outer skirt 1001 can be an integrated structure with the coating 10, or it can be connected to the coating 10 by suturing, gluing, etc.

[0087] In some embodiments, the artificial valve leaflet 9 may comprise one or more synthetic materials, engineered biological tissues, biological valve leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, chemically or biologically processed / treated tissues, or combinations thereof. In some embodiments, the pericardial tissue is selected from but not limited to a group consisting of bovine, equine, porcine, sheep, and human tissues or a combination thereof.

[0088] In some embodiments, in order to facilitate the stent 100 to better cooperate with the delivery device for delivery, the outflow end of the positioning member 2 is fixedly connected with a connecting portion 5, and the connecting portion 5 is used to connect with the delivery system. Further, in order to better cooperate with the delivery device for delivery, the connecting portion 5 includes a connecting web 501, 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 a connecting block 502, and the circumferential width of the connecting block 502 is greater than the circumferential width of the connecting web 501. Through such a design of the connecting portion 5, the connection and separation between the distal end 300 of the delivery system and the outflow end of the stent 100 can be facilitated. Figure 32 、 Figure 33The working principle of the distal end 300 of the delivery system (the "distal end" in this embodiment refers to the side of the delivery system away from the end manipulated by the user) is described. During the delivery process, the stent 100 is in a compressed state. The distal end 300 of the delivery system includes an outer catheter 301. A middle catheter 304 is provided inside the outer catheter 301. The distal end of the middle catheter 304 is provided with a groove 30401 that matches the connecting portion 5 of the stent 100. The circumferential width of the outflow end of the connecting portion 5 is greater than the circumferential width of the connecting web 501, 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 stent 100 The connecting portion 5 can be stably restricted in the groove 30401 in the axial direction, and the outer conduit 301 surrounds the middle conduit 304, so that the connecting portion 5 of the stent 100 cannot pop out from the groove 30401, and the outflow end of the stent 100 is also in a compressed state. An inner conduit 302 is provided inside the middle conduit 304, and the inner conduit 302 passes through the interior of the stent 100. A sleeve 303 is connected to the distal end of the inner conduit 302. The sleeve 303 is provided on the outside of the distal end of the inner conduit 302, and a gap for installing the stent 100 is left between the sleeve 303 and the inner conduit 302. The sleeve 303 compresses the inflow end of the stent 100, including the inflow end of the positioning member 2, the reinforcement member 3, etc., inside its sleeve 303. That is, the gap between the sleeve 303 and the inner catheter 302, thereby keeping the inflow end of the stent 100 in a compressed state, and finally transporting the stent 100 in a compressed state. When releasing the stent 100, the inner catheter 302 and the sleeve 303 are pushed first, so that the positioning member 2 is released from the sleeve 303. Of course, by pulling back the outer catheter 301 and the middle catheter 304 together, the stent 100 is driven to move backward, so that the positioning member 2 is released from the sleeve 303. The positioning member 2 is aligned with the native aortic leaflet, and the outer catheter 301 and the middle catheter 304 (or the outer catheter 301, the middle catheter 304 and the inner catheter 302) are pushed forward so that the positioning member 2 captures the native leaflet, that is, the positioning member 2 is inserted into the aortic sinus. At this time, Push the inner catheter 302 and the sleeve 303 forward to completely release the inflow end of the stent 100, that is, the inflow end of the stent 100 is completely detached and released from the sleeve 303, and then pull back the outer catheter 301 or push the middle catheter 304 forward to make the connecting part 5 of the stent 100 or the groove 30401 of the middle catheter 304 detach from the coverage of the outer catheter 301. At this time, the connecting part 5 of the outflow end of the stent 100 has no radial expansion resistance. Under the expansion action of the stent 100, the connecting part 5 pops out of the groove 30401, so that the outflow end of the stent 100 detaches from the distal end 300 of the delivery system, thereby completing the complete release of the entire stent 100, and then the delivery system is withdrawn from the human body, and the stent 100 will remain stably in the heart.

[0089] 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, that is, when the stent 100 is working in the heart, the heart is in diastole (left ventricular diastole), and the blood in the aorta will reversely impact the artificial valve leaflet 9. At this time, the blood may flow back along the gap between the native 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 short, and there is no covering 10 on the upper part of the retainer 1, so the possibility of backflow is greater. Figure 22 、 Figure 23 As shown, the inflow end portion of the retainer 1 presents a teardrop-shaped structure when in a compressed state, and the inflow end portion of the retainer 1 presents a U-shaped structure when in an expanded state, which greatly reduces the opening size of the inflow end of the retainer 1 when the stent 100 is working, effectively preventing the blood from flowing back through the inflow end of the retainer 1, or making the blood backflow within the allowable range, and preventing a large amount of blood from flowing back through the inflow end of the retainer 1. Further, as Figure 22 、 Figure 23 As shown, in order to match the shape of the inflow end of the retaining member 1, the inflow end portion of the positioning member 2 presents a teardrop-shaped structure when in a compressed state. Such a design not only matches the retaining member 1, but also when the positioning member 2 captures the native aortic valve leaflet, the circumferential size of the inflow end of the positioning member 2 is relatively small, making it easier to capture the native aortic valve leaflet and insert it into the aortic sinus.

[0090] In some embodiments, as Figure 5 As shown, the inflow end of the retainer 1 is fixedly connected to the anchoring portion 8 to form a relatively stable structure. Further, a reinforcing support portion 6 is provided inside the retainer 1, the outflow end of the reinforcing support portion 6 is connected to the retainer 1, and the inflow end of the reinforcing support portion is connected to the anchoring portion 8. The main function of the reinforcing support portion 6 is to increase the circumferential support force of the stent 100 and provide a fixing point for the coating 10 of the stent 100. Further, as shown Figures 18-21 As shown in the middle reinforcement support part 6, the reinforcement support part 6 can be composed of a plurality of single connecting rods without a cross structure, for example, two connecting rods are independently composed or four connecting rods are independently composed (such as Figure 18 、 Figure 19 As shown), it can also be formed by forming a diamond grid by a plurality of connecting rods intersecting the structure, and forming a reinforcing support portion 6 (as shown in FIG. Figure 20 ), or a combination of the two (as shown in Figure 21 As shown), further, the reinforcing support portion 6 can have one connection point or multiple connection points with the anchoring portion 8.

[0091] In some embodiments, as Figures 18-21As shown, the inflow end of the retaining member 1 is not connected to the anchoring portion 8, and the retaining member 1 is connected to the anchoring portion 8 through the reinforcing support portion 6, so that the anchoring portion 8 is not directly connected to the retaining member 1, thereby making the anchoring portion 8 have a certain flexibility relative to the retaining member 1, thereby improving its applicability. The main function of the reinforcing support portion 6 is to connect the anchoring portion 8 to the retaining member 1, while also increasing the circumferential support force of the stent 100 and providing a fixing point for the coating 10 of the stent 100.

[0092] In some embodiments, as Figure 18 As shown, the anchoring portion 8 is formed by connecting circumferentially connected diamond grids, which maintains the compression performance of the anchoring portion 8. Furthermore, the anchoring portion 8 can also be other compressible and expandable structures such as a broken line structure. The diameter of the outflow end of the anchoring portion 8 is smaller than the diameter of the inflow end of the anchoring portion 8, so that the anchoring portion 8 forms a structure in which the inflow end of the anchoring portion 8 expands outward relative to the outflow end of the anchoring portion 8, so that the anchoring portion 8 can firmly contact the valve ring, thereby limiting the stent 100 from moving away from the heart in the axial direction.

[0093] In some embodiments, as Figure 34 As shown, the native leaflet of the human aorta is generally composed of three native leaflets, and the corresponding stent 100 includes three circumferentially connected retaining members 1 and three corresponding positioning members 2, so that each native leaflet is clamped by a corresponding retaining member 1 and positioning member 2.

[0094] In addition, the stent 100 can be cut from a nickel-titanium tube, but it should be noted that the material used can be any elastic material that can be implanted in the human body.

[0095] Although the embodiments of the present application have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and variations may be made to these embodiments without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.

Claims

1. An aortic regurgitation stent with a flexible positioning member, comprising a retaining member and a positioning member, wherein the 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; At least one of the positioning members is controlled by a pull wire, the pull wire controlling the opening angle of the positioning member relative to the axis of the stent when the stent is compressed, and the positioning member is opened to a position higher than the outflow end of the native valve leaflet under the control of the pull wire without retracting the stent; The positioning member is inserted into the aortic sinus, and the outflow end of the positioning member is fixedly connected to the outflow end of the retaining member through an extension rod. A reinforcement member is provided in the middle of the positioning member, and the two ends of the reinforcement member are respectively connected to the inner sides of both sides of the positioning member. The reinforcement member is a V-shaped structure. Under the control of the pull wire, the opening angle range of the positioning member relative to the axis of the bracket is 20° to 90°.

2. The aortic regurgitation stent with a flexible positioning member according to claim 1, characterized in that: The inflow end of the positioning member is reopened under the control of the pull wire to capture the native valve leaflet for a second time.

3. The aortic regurgitation stent with a flexible positioning member according to claim 1, wherein: A wire drawing compound ring is provided inside the inflow end of the positioning member, a wire drawing hole is provided at the outflow end of the wire drawing compound ring, and the inflow end portion of the wire drawing compound ring is used for development.

4. The aortic regurgitation stent with a flexible positioning member according to claim 3, characterized in that: The wire drawing composite ring includes a connecting rod and a wire drawing ring. The inflow end of the connecting rod is fixedly connected to the inflow end of the positioning member. The outflow end of the connecting rod is fixedly connected to the wire drawing ring. The wire drawing ring is provided with a wire drawing hole.

5. The aortic regurgitation stent with a flexible positioning member according to claim 1, wherein: The positioning member and the retaining member have cooperative shapes to retain the native leaflets of the heart valve therebetween.

6. The aortic regurgitation stent with a flexible positioning member according to claim 1, wherein: The diameter of the circle (O1) where the edges of both sides of the inflow end of the positioning member are located is smaller than the diameter of the circle (O2) where the edges of the middle parts of both sides of the inflow end of the positioning member are located.

7. The aortic regurgitation stent with a flexible positioning member according to claim 1, wherein: The outflow end of the positioning member is fixedly connected to a connecting portion, which is used to connect to a conveying system. The connecting portion includes a connecting web, the inflow end of the connecting web is connected to the outflow end of the positioning member, and the outflow end of the connecting web is connected to a connecting block, and the circumferential width of the connecting block is greater than the circumferential width of the connecting web.

8. The aortic regurgitation stent with a flexible positioning member according to any one of claims 1 to 7, characterized in that: The inflow end of the retaining member is fixedly connected to the anchoring portion, a reinforcing support portion is provided inside the retaining member, the outflow end of the reinforcing support portion is connected to the retaining member, and the inflow end of the reinforcing support portion is connected to the anchoring portion.

9. The aortic regurgitation stent with a flexible positioning member according to claim 8, characterized in that: The anchoring portion is formed by connecting circumferentially connected diamond grids, and the diameter of the outflow end of the anchoring portion is smaller than the diameter of the inflow end of the anchoring portion.

10. The aortic regurgitation stent with a flexible positioning member according to any one of claims 1 to 7, characterized in that: A leaflet suturing hole is provided inside the extension rod, and the leaflet suturing hole is used to fix the outflow end of the artificial leaflet. The outflow end of the artificial leaflet is closer to the outflow end of the stent than the outflow end of the retaining member.

11. The aortic regurgitation stent with a flexible positioning member according to any one of claims 1 to 7, characterized in that: The inflow end portion of the retaining member presents a teardrop-shaped structure in a compressed state, the inflow end portion of the retaining member presents a U-shaped structure in an expanded state, and the inflow end portion of the positioning member presents a teardrop-shaped structure in a compressed state.

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