CN116869705A

CN116869705A - Aortic regurgitation support with positioning piece flexible

Info

Publication number: CN116869705A
Application number: CN202310838434.8A
Authority: CN
Inventors: 王春光; 耿肖肖; 戴志成; 葛云龙; 陈真; 龚书珺; 吴明明; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-03-28
Filing date: 2022-11-08
Publication date: 2023-10-13
Also published as: CN116849870A; CN115105259B; CN219000725U; CN218792637U; CN218356471U; CN219000720U; CN116807684A; CN115624416A; CN218356470U; CN117752468A; CN117752467A; CN115670750A; CN116849869A; CN218356472U; CN219332099U; WO2023184639A1; CN115381597A; CN115105259A; CN116807686A; CN218792636U

Abstract

The application discloses an aortic reflux bracket with a flexible positioning piece, which relates to the technical field of medical appliances and comprises a plurality of holding pieces, a plurality of positioning pieces and an anchoring part, wherein the upper side of one holding piece is correspondingly provided with one positioning piece, the outflow end of the positioning piece is fixedly connected with the outflow end of the holding piece, and the inflow end of the holding piece is provided with the anchoring part; wherein, the outflow end of setting element is wave line crooked pole structure, and does benefit to the setting element and catches native valve leaf, and need not the horizontal direction and remove the adjustment support, the operation degree of difficulty has been reduced, set up to wave line crooked pole structure through the setting element outflow end, the stability of setting element centre gripping native valve leaf has been increased, the range of deformation of setting element outflow end junction has been reduced, reduce the injury of setting element inflow end to the aortic sinus bottom, the direct tearing power to artifical valve leaf of suture line has been reduced through the abrasionproof strip setting, the life of artifical heart valve has been improved, do benefit to the permanent work in the human body of artifical heart valve.

Description

Aortic regurgitation support with positioning piece flexible

The present application claims priority from chinese patent application 2022103159315, whose application date is 2022, 03 and 28. The present application incorporates the entirety of the above-mentioned chinese patent application.

Technical Field

The application relates to the technical field of medical appliances, in particular to an aortic regurgitation bracket with a positioning piece which is flexible.

Background

Because of the advantages of small trauma and quick recovery, the transcatheter operation is becoming increasingly popular. Aortic valve replacement has also changed from early surgical procedures to transcatheter aortic valve replacement.

Chinese patent publication No. CN102413793B entitled "stent for positioning and anchoring of valve prosthesis at implantation site in heart of patient" discloses an expandable stent, which requires alignment of a plurality of positioning arches and a plurality of aortic native valve leaflets during implantation, insertion of the positioning arches into aortic sinuses, and number of times of beating of one's heart can reach 20 hundred million times, whereas after the aortic native valve is replaced with an artificial heart valve, the artificial heart valve needs to withstand the impact of blood flow in the aorta in diastole (left ventricular diastole), at this time the inflow end of the positioning arches will strike aortic sinus bottom many times, the positioning arches without buffering structure will impact aortic sinus bottom rigidly, and in the course of implantation of the stent, the positioning arches are relatively bad due to relatively straight structure, deformation occurs mainly at the connection of the positioning arches and stent, such as native valve leaflets press the positioning arches, deformation mainly depends on the connection of the positioning arches and the stent is easily damaged due to the large deformation of the positioning arches and the stent.

For this reason, it is desirable to provide a heart valve stent (regurgitation stent) that can be adapted for transcatheter aortic valve replacement with a relatively flexible positioning arc (member).

Disclosure of Invention

Aiming at the problem that the positioning arc is not flexible enough in the prior art, the application provides the aortic regurgitation bracket with the positioning piece being flexible, thereby solving the problem that the positioning arc of the regurgitation bracket is not flexible enough.

In order to achieve the above purpose, the present application provides the following technical solutions:

the aortic regurgitation support comprises a plurality of retainers, a plurality of retainers and an anchoring part, wherein the upper side of one retainer is correspondingly provided with one retainer, the outflow end of the retainer is fixedly connected with the outflow end of the retainer, and the inflow end of the retainer is provided with the anchoring part;

wherein, the outflow end of setting element is wave line crooked pole structure.

Preferably, the wavy line bending bar structure shown is formed by alternating transverse U-shaped structural bars.

Preferably, at least one positioning piece is controlled by a stay wire, and the openable angle range of the positioning piece relative to the axis of the bracket is 20-90 degrees under the control of the stay wire.

Preferably, a stay wire compound ring is arranged on the inner side of the inflow end of the positioning piece, a stay wire hole is formed in the outflow end of the stay wire compound ring, and the inflow end portion of the stay wire compound ring is used for developing.

Preferably, the stay wire compound ring comprises a connecting rod and a stay wire ring, wherein the inflow end of the connecting rod is fixedly connected with the inflow end of the positioning piece, the outflow end of the connecting rod is fixedly connected with the stay wire ring, and the stay wire ring is provided with a stay wire hole.

Preferably, the positioning member and the retaining member have cooperating shapes that retain the native leaflets of the heart valve between the positioning member and the retaining member.

Preferably, the diameter of the circle (O1) at the edges of the two sides of the inflow end of the positioning member is smaller than the diameter of the circle (O2) at the edges of the middle parts of the two sides of the inflow end of the positioning member.

Preferably, the outflow end of the positioning piece is fixedly connected with the outflow end of the retaining piece through an extension rod, a leaflet stitching hole is formed in the extension rod and used for fixing the outflow end of the artificial leaflet, and the outflow end of the artificial leaflet is closer to the outflow end of the bracket than the outflow end of the retaining piece.

Preferably, the artificial valve leaflet comprises an artificial valve leaflet main body and an artificial valve She Erbu arranged at the outflow end of the artificial valve leaflet main body, wherein the artificial valve She Erbu penetrates through a leaflet suture hole to wrap an extension rod, the inflow end edge of the artificial valve leaflet main body is connected with a coating, the coating is arranged on the inner side of a bracket, the outflow end of the coating is connected with a retainer, the inflow end of the coating is connected with an anchoring part, an anti-abrasion strip is arranged at the joint of the inflow end edge of the artificial valve leaflet main body and the coating, the anti-abrasion strip is of a folding structure, the cross section of the anti-abrasion strip is of a U-shaped structure, and the inflow end edge of the artificial valve leaflet main body is arranged inside the folding anti-abrasion strip.

Preferably, the folding part of the wear strip is provided with 3-10 stress notches.

Preferably, the inflow end of the membrane is everted from inside the stent to outside the stent to form an anchor portion skirt.

Preferably, the outflow end fixedly connected with connecting portion of setting element, connecting portion are used for being connected with conveying system, connecting portion includes the connecting web, the outflow end of setting element is connected to the inflow end of connecting web, the outflow end of connecting web is connected with the connecting block, the circumference width of connecting block is greater than the circumference width of connecting web.

Preferably, the inflow end portion of the retainer assumes a water droplet type configuration in the compressed state, the inflow end portion of the retainer assumes a U-shaped configuration in the expanded state, and the inflow end portion of the retainer assumes a water droplet type configuration in the compressed state.

Preferably, the inflow end of the holder is fixedly connected with the anchoring portion, the inside of the holder is provided with a reinforcing support portion, the outflow end of the reinforcing support portion is connected with the holder, and the inflow end of the reinforcing support portion is connected with the anchoring portion.

Preferably, the inflow end of the holder is not connected to the anchor portion, and the holder is connected to the anchor portion through a reinforcing support portion.

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 that of the inflow end of the anchoring portion.

Preferably, the bracket comprises three holders connected circumferentially.

Compared with the prior art, the application provides the aortic regurgitation support with the positioning piece being flexible. The beneficial effects are as follows:

1. the opening angle of the positioning piece can be controlled by a stay wire: in the transcatheter reverse flow stent implantation process, the positioning piece is required to capture the native valve leaflets, namely the positioning piece is required to be inserted into the non-closed surface of the native valve leaflets, and the retainer is positioned on the closed surface of the native valve leaflets so as to clamp the native valve leaflets, but because the aortic valve leaflets are generally composed of three native valve leaflets, when the positioning piece captures all the native valve leaflets, the positioning piece can capture two of the three native valve leaflets easily, but the positioning piece captures the three native valve leaflets at one time is relatively difficult, because the three native valve leaflets are enclosed into a circle, each native valve leaflet is adjacent, difficult to adjust, and the native valve leaflets are movable, the three native valve leaflets are relatively difficult to capture at one time.

2. The outflow end of the positioning piece is arranged into a wave line bending rod structure: when the locating piece is used for clamping the primary valve leaflet, the outflow end of the locating piece corresponds to the outflow end of the primary valve leaflet, the contact area between the locating piece and the primary valve leaflet is increased through the bent structure, the stability of the locating piece for clamping the primary valve leaflet is effectively increased, secondly, when the stay wire is used for controlling the locating piece to open a larger angle, the locating piece can be opened through bending by the bent structure part in an open mode, the deformation amplitude of the connecting part of the outflow end of the locating piece is reduced, the damage possibly caused by the deformation stress of the locating piece is reduced, finally, the locating piece has certain elasticity in the axial direction through the bent structure, and when blood reflux is blocked in the diastole, the impact force of blood reflux can be buffered, and the damage of the inflow end of the locating piece to the aortic sinus bottom is reduced.

3. The artificial valve leaflet and the tectorial membrane are connected through the structure that the wear-resistant strip is folded: the edge of the inflow end of the artificial valve main body is arranged inside the folded anti-abrasion strip, the edge of the artificial valve main body is completely wrapped, the edge tearing resistance of the artificial valve main body is effectively improved, when the suture is used for fixing the artificial valve and the covering film, the acting force generated by the suture line positioned at the artificial valve She Nace (close to the axis direction of the bracket) is directly acted on the artificial valve compared with the traditional anti-abrasion strip positioned between the artificial valve and the covering film, so that the acting force generated by the suture line positioned at the artificial valve She Nace (close to the axis direction of the bracket) is easy to damage the artificial valve, the edge of the artificial valve main body is completely wrapped by the folded anti-abrasion strip with the U-shaped structure, the force generated by the suture line is completely acted on the anti-abrasion strip, the tearing force of the suture line to the artificial valve is directly reduced, the service life of the artificial heart valve is prolonged, and the artificial heart valve can work in a human body for a long time.

Drawings

The specific features of the application related to the application are shown in the appended claims. A better understanding of the features and advantages of the application in accordance with the present application will be obtained by reference to the exemplary embodiments and the accompanying drawings that are described in detail below. The drawings are briefly described as follows:

FIG. 1 is a schematic view of a reverse flow stand and marker according to an embodiment of the present application;

FIG. 2 is an expanded view of the reverse flow stent of FIG. 1;

FIG. 3 is an enlarged view of a portion of FIG. 2;

FIG. 4 is a front view of a reverse flow stand according to another embodiment of the present application;

FIG. 5 is a schematic view of the reverse flow stand of FIG. 4;

FIG. 6 is a schematic view of the structure of the reverse flow stand and the C-shaped member in FIG. 4;

FIG. 7 is an enlarged view of a portion of FIG. 6;

FIG. 8 is a schematic structural view of a C-shaped member;

FIG. 9 is an expanded view of the reverse flow stent of FIG. 4;

FIG. 10 is an enlarged view of a portion of FIG. 9;

FIG. 11 is an enlarged view of a portion of FIG. 10;

FIG. 12 is a schematic view of a reverse flow stand according to another embodiment of the present application;

FIG. 13 is an enlarged view of a portion of FIG. 12;

FIG. 14 is an expanded view of the reverse flow stent of FIG. 12;

FIG. 15 is a schematic view of a reverse flow stand according to another embodiment of the present application;

FIG. 16 is an enlarged view of a portion of FIG. 15;

FIG. 17 is an expanded view of the reverse flow stent of FIG. 15;

FIG. 18 is a schematic view of a reverse flow stand according to another embodiment of the present application;

FIG. 19 is an expanded view of the reverse flow stent of FIG. 18;

FIG. 20 is an expanded view of a reverse flow stent according to another embodiment of the present application;

FIG. 21 is an expanded view of a reverse flow stent according to another embodiment of the present application;

FIG. 22 is a schematic view showing a compressed state of a reverse flow stent according to another embodiment of the present application;

FIG. 23 is an enlarged view of a portion of FIG. 22;

FIG. 24 is a schematic view of the structure of an artificial leaflet and wear strip of the present application;

FIG. 25 is an expanded view of the wear strip of the present application;

FIG. 26 is a schematic view of an artificial leaflet, wear strip and film structure of the present application;

FIG. 27 is a schematic view of another artificial leaflet, wear strip and film structure of the present application;

FIG. 28 is a schematic view of the structure of a regurgitant stent, a coating film and artificial valve leaflet according to the present application;

FIG. 29 is a schematic view of the structure of a regurgitant stent, a stent graft, artificial leaflets and an outer skirt in the present application;

FIG. 30 is a schematic illustration of the application with the positioning member of the regurgitation stent open in preparation for alignment of the native aortic valve leaflets for capture;

FIG. 31 is a schematic view of a positioning member of a regurgitation stent of the present application aligned with the native aortic valve leaflet and inserted into the aortic sinus;

FIG. 32 is a schematic view of the distal portion of the delivery system of the present application;

FIG. 33 is a schematic view of the distal portion of the delivery system of the present application with the outer catheter removed;

fig. 34 is a schematic view of an aortic native valve leaflet.

Reference numerals illustrate:

100. stent, 300, distal delivery system, 301, outer catheter, 302, inner catheter, 303, cannula, 304, middle catheter, 30401, groove, 1, holder, 2, positioner, 201, wavy line bending rod structure, 3, stiffener, 4, extension rod, 401, leaflet suture hole, 5, connection, 501, connection web, 502, connection block, 6, reinforcing support, 7, pull wire composite ring, 701, pull wire ring, 702, connection rod, 703, C-shaped member, 70301, C-shaped outer sidewall, 70302, C-shaped two sidewalls, 7C, pull wire composite ring, 7C01, marker insertion hole, 77, pull wire hole, 8, anchor, 9, artificial leaflet, 901, artificial leaflet She Zhuti, 902, artificial leaflet She Erbu, 10, covering, 1001, outer skirt, 11, wear strip, 1101, stress gap, 1102, fold line, 11', conventional wear strip, 1000, inflow end, 2000, outflow end.

Detailed Description

Other advantages and effects of the present application will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present application with reference to specific examples. The application may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present application. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict.

It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element.

It should be noted that, in this context, the height direction is substantially along the axis of the prosthetic heart valve, except as specifically described herein, reference is made directly herein to high, low, up, down, etc., where "high", "up" refer to the position of the outflow end of the prosthetic heart valve in the proximal expanded state (as shown in fig. 1), and "low", "down" refer to the position of the inflow end of the prosthetic heart valve in the proximal expanded state, where "inflow end" refers to the position in the upstream direction of blood flow, i.e., the end of the stent that first passes blood in the expanded state, as shown in fig. 4, where "outflow end" refers to the position in the downstream direction of blood flow, i.e., the end of the stent that exits the expanded state, as shown in fig. 4, and the outflow end 2000.

The application provides a technical scheme that: the utility model provides a flexible aortic regurgitation support of setting element, includes a plurality of holders 1, a plurality of location 2 piece and anchoring portion 8, and the upside of a said holder corresponds to and sets up a setting element, the outflow end of setting element 2 and the outflow end fixed connection of holder 1, the inflow end of holder 1 is provided with anchoring portion 8, utilizes setting element 2 and holder 1 centre gripping native valve leaf, reuse anchoring portion 8 card on the aortic valve annulus to make this regurgitation support stable existence in aortic native valve position;

as shown in fig. 12-14, the outflow end of the positioning member 2 is a wavy curved rod structure 201, which mainly has three points, firstly, when the positioning member 2 clamps the native valve leaflet, the outflow end of the positioning member 2 corresponds to the outflow end of the native valve leaflet, that is, the free end of the native valve leaflet, the wavy curved rod structure 201 increases the contact area between the positioning member 2 and the native valve leaflet, effectively increases the stability of the positioning member 2 clamping the native valve leaflet, secondly, when the stay wire is used to control the positioning member 2 to open at a larger angle, the open deformation of the positioning member 2 can be partially bent by the wavy curved rod structure 201 to open the positioning member 2, so that the deformation amplitude of the connection part of the outflow end of the positioning member 2 is reduced, the damage of the connection part of the outflow end of the positioning member 2 possibly caused by the deformation stress of the positioning member 2 is reduced, and finally, the wavy curved rod structure 201 also enables the positioning member 2 to have a certain elasticity in the axial direction, and can buffer the impact force of blood when the blood is blocked from flowing back in the diastole stage, and the damage of the inflow end of the positioning member 2 to the aortic sinus is reduced.

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

In some embodiments, in the process of implantation of the reflux stent through the catheter, the positioning piece 2 needs to be used for capturing the native valve leaflets, namely, the positioning piece 2 needs to be inserted into the non-closed surface of the native valve leaflets, and the retainer 1 is positioned on the closed surface of the native valve leaflets, so that the retainer 1 and the positioning piece 2 clamp the native valve leaflets, but since the aortic native valve leaflets are generally composed of three native valve leaflets (as shown in fig. 34), the positioning piece 2 is generally at least three, corresponding to all the native valve leaflets needing to be captured, the positioning piece 2 can capture two of the native valve leaflets at one time, but is relatively difficult to capture three native valve leaflets at one time, and when the positioning piece 2 and the native valve leaflets are aligned, the positioning piece 2 is necessarily far away from and close to the non-closed surface of the native valve leaflets when the stent 100 is moved in the horizontal (vertical stent 100 axis), and the capturing time of the native valve leaflets is also very important, so that all the positioning piece 2 is relatively difficult to capture three valve leaflets at one time, and thus the opening angle of the positioning piece 2 can be controlled to be more easily by the opening the stent 2, and the opening angle of the positioning piece can be controlled to enable the positioning piece 2 to be more easily controlled to be opened for opening the position the open and the valve leaflets to be more difficult to capture the position by using at least three of the open the axial surfaces of the stent 2;

Here, at least one positioning piece 2 is controlled by a stay wire, the openable angle range of the positioning piece 2 relative to the axis of the bracket 100 is 20 ° to 60 °, such as 21 °, 23 °, 25 °, 28 °, 30 °, 33 °, 35 °, 38 °, 40 °, 43 °, 45 °, 48 °, 50 °, 53 °, 55 °, 58 °, 60 °, under the control of the stay wire, when the positioning piece 2 is captured or aligned with the non-closed surface of the native valve, the positioning piece 2 can be opened by a larger angle without horizontally moving the bracket 100, so as to obtain a larger radial overhanging size, and the positioning piece 2 is aligned with the non-closed surface of the native valve, so that the positioning piece 2 of the bracket 100 captures the native valve smoothly;

further, the positioning member 2 can be opened by an angle ranging from 60 ° to 90 ° relative to the axis of the stent 100 under the control of the pull wire, where a larger angle is opened, for example, approximately 90 °, and another main purpose is to remedy the failure of the positioning member 2 to capture the native valve leaflet, that is, although the positioning member 2 is opened by the pull wire to a larger angle (as shown in fig. 30) before capturing the native valve leaflet, to facilitate capturing the native valve leaflet, and then pushing the positioning member 2 into the non-closed surface of the native valve leaflet (as shown in fig. 31) moves the stent 100 toward the ventricle, but due to, for example: the original valve leaves are moved in the pushing process of the positioning piece 2, and the imaging equipment is at an poor angle, the development is unclear, and the like, so that the positioning piece 2 cannot be successfully inserted into the non-closed surface of the original valve leaves, the traditional bracket 100 which cannot control the opening angle of the positioning piece 2 can only be retracted, namely, the positioning piece 2 is withdrawn from the non-closed surface of the original valve leaves, the capturing of the original valve leaves is carried out again, the positioning piece 2 can be opened at a larger angle, for example, 75 degrees, 76 degrees, 77 degrees, 78 degrees, 79 degrees, 80 degrees, 81 degrees, 82 degrees, 83 degrees, 84 degrees, 85 degrees, 86 degrees, 87 degrees, 88 degrees, 89 degrees and 90 degrees, under the condition that the retraction of the bracket 100 is not carried out, the inflow end of the positioning piece 2 which is not inserted into the non-closed surface of the original valve leaves is opened to a position higher than the outflow end of the original valve leaves which is not captured, the positioning piece 2 is put down again, so that secondary capturing of the native valve leaflet is realized, because the stent 100 is in a compressed state at this time, enough space is reserved in the aorta to open the positioning piece 2, although the inflow end of the positioning piece 2 possibly touches the aortic wall, the time is short, namely the inflow end of the positioning piece 2 does not touch the aortic wall any more in the later period, and the positioning piece 2 is opened in the compressed state of the stent 100, namely the opening of the positioning piece 2 in the compressed state of the stent 100 does not form an excessive horizontal outline dimension of the stent 100, namely no large force is generated on the aortic wall, so that the positioning piece 2 can be opened at a relatively large angle under the control of a pull wire to secondarily capture the native valve leaflet.

In some embodiments, as shown in fig. 1-3, the inner side of the inflow end of the positioning member 2 is provided with a pull-wire compound ring 7C, where the inner side of the inflow end of the positioning member 2 is the upper side of the positioning member 2, and since the positioning member 2 is a V-shaped like structure as a whole, the concave side (i.e., the upper side) thereof is the inner side, it is apparent that the position of the pull-wire compound ring 7C is also clearly shown in fig. 1-3, since the positioning member 2 needs to capture the native valve leaflet, the position of the inflow end of the positioning member 2 is particularly important, the position of the inflow end of the positioning member 2 can be clearly shown on the imaging device, the inflow end portion of the pull-wire compound ring 7C is used for developing, the embodiment herein is to use the mark-inserting hole 7C01 opened at the inflow end of the pull-wire compound ring 7C, and a marker is embedded in the marker embedding hole 7C01 (the marker is radiopaque) so as to facilitate the accurate positioning implantation of the positioning piece 2, ensure that the positioning piece 2 can accurately capture the native valve leaflet and insert into the sinus floor, the outflow end of the guy wire compound ring 7C is provided with a guy wire hole 77, the guy wire hole 77 is used for penetrating guy wires, the guy wire is used for controlling the positioning piece 2 to open a larger angle through the guy wire hole 77, the positioning piece 2 is convenient for capturing the native valve leaflet, the operation difficulty is reduced, and meanwhile, the guy wire compound ring 7C structure arranged at the inflow end of the positioning piece 2 combines the guy wire control and developing function into one position (guy wire compound ring 7C), the space utilization of the product is effectively improved, and the description is that although the guy wire compound ring 7C is in the shape of a gourd in the figures 1-3, the shape of the guy wire compound ring comprises but is not limited to the shape of a gourd, the stay wire composite ring 7C may be rectangular, triangular, oval, etc. and may have a specific shape, or may have an auxiliary recognition function, for example, may be a gourd shape, rectangular, triangular, oval, etc. in the imaging device, so that it is more beneficial to observation.

In some embodiments, as shown in fig. 4-8, by inserting a marker "into the marker insertion hole 7C01 at the inflow end of the pull wire composite ring 7C (as shown in fig. 1), although the positioning member 2 can be positioned by observing the inflow end, the size of the marker" is limited by the size limitation of the marker insertion hole 7C01 at the inflow end of the pull wire composite ring 7C (as shown in fig. 1), which is not beneficial to the observation in developing or the difficulty in observing due to the smaller size of the marker ", and in order to increase the developing function of the pull wire composite ring 7, the pull wire composite ring 7 comprises a connecting rod 702 and a pull wire ring 701, a C-shaped member 703 is mounted on the connecting rod 702, and the C-shaped member 703 is made of a radiopaque metal and can present a clear image under an imaging device, moreover, because the C-shaped member 703 is wrapped on the connecting rod 702, as shown in FIG. 8, the C-shaped member 703 is a member with a cross section similar to that of a C, and the opening of the C-shaped member 703 can be opened and closed for being mounted on the connecting rod 702, wherein one side of the C-shaped member 703 far away from the axial direction of the bracket 100 is a C-shaped outer side wall 70301, the side walls clamped on two sides of the circumferential direction of the connecting rod 702 are C-shaped side walls 70302, in order to reduce the unevenness of the outer surface of the wire drawing composite ring 7 caused by the C-shaped member 703, the thickness of the C-shaped outer side wall 70301 is smaller than that of the C-shaped side walls 70302, the C-shaped member 703 is wrapped on the connecting rod 702, so that the volume of the C-shaped member 703 is relatively larger, the observation is more convenient, the observation difficulty is reduced, the inflow end of the connecting rod 702 is fixedly connected with the inflow end of the positioning member 2, the outflow end of the connecting rod 702 is fixedly connected with the wire drawing ring 701, the maximum outline dimension of the stay wire ring 701 is larger than the width (circumferential) dimension of the connecting rod 702, so that the C-shaped piece 703 is prevented from sliding off from the connecting rod 702, the C-shaped piece 703 is firmly limited between the inner side of the inflow end of the positioning piece 2 and the stay wire ring 701, the stay wire ring 701 is provided with a stay wire hole 77, the stay wire hole 77 is used for penetrating a stay wire, and the stay wire is used for controlling the positioning piece 2 to open a larger angle through the stay wire hole 77.

In some embodiments, in order to better enable the stent 100 to clamp the native valve leaflet, the positioning member 2 and the retaining member 1 have a cooperative shape, i.e., the positioning member 2 has a shape substantially the same as that of the retaining member 1, and the native valve leaflet of the heart valve is clamped between the positioning member 2 and the retaining member 1, and since the positioning member 2 has a shape substantially the same as that of the retaining member 1, the native valve leaflet can be firmly and effectively fixed.

In some embodiments, as shown in fig. 9-11, since the positioning member 2 needs to be inserted into the bottom of the aortic sinus, in diastole, i.e. when the left ventricle is in diastole, and the aortic valve (the prosthetic heart valve/the stent 100) is closed to prevent the blood from flowing back to the heart from the aorta, the prosthetic heart valve needs to bear a certain reverse pressure to prevent the blood from flowing back, since the positioning member 2 is inserted into the aortic sinus, the inflow end of the positioning member 2 will be pushed down against 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, the contact area between the inflow end of the positioning member 2 and the bottom of the aortic sinus is increased, the diameter of the circle (O1) on the edges on both sides of the inflow end of the positioning member 2 is smaller than the diameter of the circle (O2) on the edges on the middle part on both sides of the inflow end of the positioning member 2, and further, the inflow end of the positioning member 2 can be wrapped, for example, the inflow end of the positioning member 2 can be wrapped with the same material as the artificial valve 9, so that the inflow end of the positioning member 2 forms a relatively soft inflow end of the positioning member 2.

In some embodiments, the middle part of setting element 2 is provided with reinforcement 3, and the effective area of contact of setting element 2 and native valve leaf that has increased of being provided with of reinforcement 3, the both ends of reinforcement 3 are connected in the inboard on the both sides of setting element 2 respectively, and in this embodiment, reinforcement 3 is the structure of V type, can realize the compression and the inflation of reinforcement 3, and the both ends of reinforcement 3 are close to setting element 2 outflow end portion relatively with the setting element 2 junction, and it also effectually increases the circumference holding power of setting element 2 outflow end, has increased the stability of whole support 100.

In some embodiments, since each person is an independent individual, there is a slight gap between the aortic valve, so the outflow end of the positioning member 2 and the outflow end of the holding member 1 are fixedly connected through the extension rod 4, which increases the adjusting capability of a certain positioning member 2 relative to the holding member 1, and can adjust and control the length of the whole stent 100 to a certain extent, so that the device can be suitable for a wider population;

further, in order to increase the closure performance of the outflow end of the artificial valve leaflet 9, the inside of the extension rod 4 is provided with the valve leaflet suture hole 401, the valve leaflet suture hole 401 is used for fixing the outflow end of the artificial valve leaflet 9, the outflow ends of the adjacent artificial valve leaflets 9 are tightly combined and attached together through the valve leaflet suture hole 401, the backflow of blood is effectively prevented from occurring at the closed position of the outflow end of the artificial valve leaflet 9, as shown in fig. 28, the outflow ends of the artificial valve leaflets 9 are matched with the extension rod 4 through the arrangement of the extension rod 4, an artificial valve leaflet 9 outflow end closure section with a longer axial direction is formed, the tightness between the artificial valve leaflets 9 is increased, because the extension rod 4 is arranged on the upper side of the outflow end of the retainer 1, the outflow ends of the artificial valve leaflets 9 are closer to the outflow end of the bracket 100 than the outflow end of the retainer 1, the formed closure section of the artificial valve leaflet 9 is also located at a position closer to the outflow end of the bracket 100 than the outflow end of the retainer 1, the axial direction of the artificial valve leaflet 9 is effectively prolonged, the axial direction of the artificial valve leaflet 9 is not prolonged, the axial direction of the artificial valve leaflet 9 is prevented from being increased, the axial direction of the artificial valve leaflet 9 is not to be prolonged, and the axial direction of the artificial valve leaflet 9 is not prolonged, and the axial direction is not prolonged, and the artificial valve leaflet 9 is not longer than the axial, because the artificial valve leaflet 9 is not longer than the closed, and the artificial valve leaflet 9 is not longer than the closed.

In some embodiments, as shown in fig. 24-29, the artificial valve leaflet 9 includes an artificial valve leaflet main body 901 and an artificial valve She Erbu disposed at an outflow end of the artificial valve leaflet main body 901, the artificial valve She Erbu wraps the extension rod 4 through the valve leaflet suture hole 401, an inflow end edge of the artificial valve leaflet main body 901 is connected with the covering film 10, the covering film 10 is mounted inside the support 100, the outflow end of the covering film 10 is connected with the retainer 1, the inflow end of the covering film 10 is connected with the anchoring portion 8, an anti-abrasion strip 11 is disposed at a connection position between the inflow end edge of the artificial valve leaflet main body 901 and the covering film 10, the anti-abrasion strip 11 firstly increases the tearing resistance of the inflow end of the artificial valve leaflet 9, secondly reduces the damage to the artificial valve leaflet 9 due to the friction between the inflow end of the artificial valve leaflet 9 and the covering film 10, improves the service life of the artificial valve leaflet 9, and the arrangement of the anti-abrasion strip 11 is equivalent to a buffer layer between the artificial valve leaflet 9 and the covering film 10, effectively buffering the service life of the artificial valve leaflet 9 against the tearing force of the covering film 10 during the opening and closing of the heart valve; further, the wear-resistant strip 11 is designed as follows, the wear-resistant strip 11 is in a folded structure, that is, the cross section of the wear-resistant strip 11 is in a U-shaped structure, the edge of the inflow end of the artificial valve main body 901 is arranged inside the folded wear-resistant strip 11, the edge of the artificial valve main body 901 is completely wrapped, the edge tearing resistance of the artificial valve main body 901 is effectively increased, when the suture line is used for fixing the artificial valve 9 and the covering film 10, compared with the conventional wear-resistant strip 11 '(shown in fig. 26), the conventional wear-resistant strip 11' is only positioned between the artificial valve 9 and the covering film 10, so that the acting force generated by a suture line positioned on the inner side (close to the axis direction of the bracket 100) of the artificial valve 9 directly acts on the artificial valve 9, and when the artificial valve main body 9 is impacted by blood, the joint of the artificial valve main body 901 and the covering film 10 is necessarily subjected to certain tearing, so that the acting force generated by the suture line positioned on the inner side (close to the axis direction of the bracket 100) of the artificial valve main body 901 is very easy to damage the artificial valve main body 9, and the artificial valve 9 is caused, and the whole artificial valve is failed, compared with the conventional wear-resistant strip 11 is used for directly wrapping the suture line, and the effect of the artificial valve is reduced, and the service life of the artificial valve is improved.

In some embodiments, as shown in fig. 25, since the edge of the artificial leaflet 9 is curved, a material extrusion overlapping phenomenon occurs when the wear strip 11 is folded, and in order to solve this phenomenon, the folded portion of the wear strip 11 is provided with 3 to 10 stress notches 1101, so as to reduce the material extrusion overlapping phenomenon of the wear strip 11 when folded, where the stress notches 1101 may be disposed outside the fold line 1102 or inside the fold line 1102, further, the material of the wear strip 11 located at both sides of the fold line 1102 may be a unitary structure, or may be formed by connecting different materials at the fold line 1102 by stitching, gluing, or the like.

In some embodiments, in order to reduce friction damage between the wear-resistant strip 11 and the artificial valve leaflet 9, and also to ensure that the wear-resistant strip 11 has the same mechanical properties as the artificial valve leaflet 9 as much as possible, so as to ensure that the artificial valve leaflet 9 has better opening and closing stability, the material of the wear-resistant strip 11 is the same as that of the artificial valve leaflet 9.

In some embodiments, as shown in fig. 29, since the outer side of the anchoring portion 8 (away from the axial direction of the stent 100) needs to contact the aortic annulus to limit the displacement of the stent 100 away from the left ventricle, the anchoring portion 8 will often contact the aortic annulus, and in order to reduce damage to the valve by the leaking anchoring portion 8 of the stent 100, the inflow end of the stent 10 is turned out from the inner side of the stent 100 to the outer side of the stent 100 to form the outer skirt 1001 of the anchoring portion 8, and further, the outer skirt 1001 may be made of a solid, durable material, such as a woven PET laser cut or otherwise formed material, or other synthetic or natural materials, and the outer skirt 1001 may be integrally formed with the stent 10, or may be connected to the stent 10 by stitching, gluing, or the like.

In some embodiments, the prosthetic leaflet 9 can comprise one or more synthetic materials, engineered biological tissue, biological leaflet tissue, pericardial tissue, crosslinked pericardial tissue, aortic root tissue, chemically or biologically processed/treated tissue, or a combination thereof, in some embodiments, pericardial tissue is selected from the group consisting of but not limited to bovine, equine, porcine, ovine, and human tissue, or a combination thereof.

In some embodiments, in order to facilitate the better matching of the stent 100 with the delivery device for delivery, the outflow end of the positioning member 2 is fixedly connected with a connecting portion 5, the connecting portion 5 is used for connecting with a delivery system, further, in order to better match the delivery device for delivery, the connecting portion 5 includes a connecting web 501, the inflow end of the connecting web 501 is connected with the outflow end of the positioning member 2, the outflow end of the connecting web 501 is connected with a connecting block 502, the circumferential width of the connecting block 502 is greater than the circumferential width of the connecting web 501, by designing such connecting portion 5, the connection and disconnection of the distal end 300 of the delivery system from the outflow end of the stent 100 can be facilitated, and the working principle of 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) will be described with reference to fig. 32 and 33, the stent 100 is in a compressed state during the delivery of the delivery system, the distal end 300 of the delivery system comprises an outer catheter 301, a middle catheter 304 is arranged inside the outer catheter 301, a groove 30401 matched with the connecting part 5 of the stent 100 is arranged at the distal end of the middle catheter 304, the circumferential width of the outflow end of the connecting part 5 is larger than that of a groove 30401 matched with the shape of the distal end of the middle catheter 304 corresponding to the circumferential width of a connecting web 501, the distal end size of the groove 30401 can pass through the connecting web 501 and can not pass through a connecting block 502, the connecting part 5 of the stent 100 can be stably limited in the groove 30401 in the axial direction, the outer catheter 301 surrounds the middle catheter 304, the connecting part 5 of the stent 100 can not pop out of the groove 30401, meanwhile, the outflow end of the stent 100 is in a compressed state, an inner catheter 302 is arranged inside the middle catheter 304, the inner catheter 302 passes through the inner part of the stent 100, the distal end of the inner catheter 302 is connected to the sleeve 303, the sleeve 303 is disposed outside the distal end portion of the inner catheter 302, a gap for mounting the stent 100 is left between the sleeve 303 and the inner catheter 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 the sleeve 303 thereof, i.e., the gap between the sleeve 303 and the inner catheter 302, thereby maintaining the inflow end of the stent 100 in a compressed state, and finally, the stent 100 is delivered in a compressed state, and when the stent 100 is released, the inner catheter 302 and the sleeve 303 are pushed previously, so that the positioning member 2 is released from the sleeve 303, and of course, by pulling the outer catheter 301 and the middle catheter 304 together, the stent 100 is driven to move backward, so that the positioning member 2 can also be released from the sleeve 303, the positioning member 2 can be aligned with the native aortic valve, and pushing forward the outer catheter 301 and the middle catheter 304 (or the outer catheter 301, the middle catheter 304 and the inner catheter 302) so that the positioning member 2 captures the native valve leaflet, i.e. the positioning member 2 is inserted into the aortic sinus, pushing forward the inner catheter 302 and the sleeve 303 again at this time so that the inflow end of the stent 100 is completely released, i.e. the inflow end of the stent 100 is completely released from the sleeve 303, then pulling back the outer catheter 301 or pushing forward the middle catheter 304 so that the connecting portion 5 of the stent 100 or the groove 30401 of the middle catheter 304 is out of the coverage area of the outer catheter 301, at this time, the connecting portion 5 of the outflow end of the stent 100 has no expansion resistance in the radial direction, under the expansion action of the stent 100, the connecting portion 5 pops out of the groove 30401, so that the outflow end of the stent 100 is out of the distal end 300 of the delivery system, thus completing the complete release of the whole stent 100, then withdrawing the delivery system from the human body, and the stent 100 will stably stay in the heart.

In some embodiments, since the inflow end of the holder 1 is relatively close to the anchoring portion 8, after the stent 100 is mounted and expanded, i.e. when the stent 100 is operated in the heart, the heart is in diastole (left ventricular diastole), at this time, blood in the aorta will reversely impact the artificial valve leaflet 9, at this time, blood may flow back along the gap between the native valve leaflet of the aorta and the stent 100, it is obvious that the distance from the inflow end of the holder 1 to the inflow end of the anchoring portion 8 is short, and the upper portion of the holder 1 has no coating 10, and the possibility of back flow is high, as shown in fig. 22 and 23, by which the inflow end portion of the holder 1 assumes a droplet-shaped configuration in a compressed state, and the inflow end portion of the holder 1 assumes a U-shaped configuration in an expanded state, so that the opening size of the inflow end of the holder 1 is greatly reduced when the stent 100 is operated, and the back flow of blood is effectively prevented from occurring through the inflow end of the holder 1, or so that the occurrence of back flow of blood is in a permissible range, and the back flow of the blood is prevented from occurring through the inflow end of the holder 1, and the inflow end of the holder 1 is largely back-flowing, and the inflow end of the blood is not formed, as shown in a large amount, and the inflow end of the holder is caught by the native valve 2, and the inflow end is located in a droplet-shaped configuration, and the inflow end is easily in a droplet-shaped configuration, and the shape, and the inflow end is located in the shape, and the opposite to the inflow end of the aortic valve 2, and the inflow end is positioned in the primary valve, and the inflow end.

In some embodiments, as shown in fig. 5, the inflow end of the retainer 1 is fixedly connected with the anchoring portion 8 to form a relatively stable structure, further, a reinforced support portion 6 is disposed inside the retainer 1, the outflow end of the reinforced support portion 6 is connected with the retainer 1, the inflow end of the reinforced support portion is connected with the anchoring portion 8, the reinforced support portion 6 mainly functions to increase the force of the circumference Xiang Zhicheng of the bracket 100, and simultaneously provides a fixing point for the covering film 10 of the bracket 100, further, as shown in fig. 18-21, the reinforced support portion 6 may be formed by a plurality of single connecting rods without a cross structure, for example, two connecting rods independently form or four connecting rods independently form (as shown in fig. 18 and 19), or after a diamond grid is formed by a plurality of connecting rods cross structure, the reinforced support portion 6 is formed by a diamond grid (as shown in fig. 20), or a combination of the two connecting rods form (as shown in fig. 21), and further, the reinforced support portion 6 may have one or a plurality of connecting points with the anchoring portion 8.

In some embodiments, as shown in fig. 18-21, the inflow end of the holder 1 is not connected to the anchoring portion 8, and the holder 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 holder 1, thereby enabling the anchoring portion 8 to have a certain flexibility with respect to the holder 1, improving the applicability thereof, and the main function of the reinforcing support portion 6 is to connect the anchoring portion 8 to the holder 1 while also increasing the force of the periphery Xiang Zhicheng of the stent 100 while providing a fixing point for the covering film 10 of the stent 100.

In some embodiments, as shown in fig. 18, the anchoring portion 8 is formed by connecting circumferentially connected diamond grids, so as to maintain the compression performance of the anchoring portion 8, further, the anchoring portion 8 may be in other compressible and expandable structures such as a fold line structure, and the diameter of the outflow end of the anchoring portion 8 is smaller than that of the inflow end of the anchoring portion 8, so that the anchoring portion 8 forms a structure that the inflow end of the anchoring portion 8 is flared relative to the outflow end of the anchoring portion 8, so that the anchoring portion 8 can firmly contact with the valve annulus, and further, the stent 100 is limited from being far away from the heart in the axial direction.

In some embodiments, as shown in fig. 34, the native aortic valve leaflet of the human is generally composed of three native valve leaflets, and the corresponding stent 100 includes three holders 1 circumferentially connected, and three positioners 2, so that each native valve leaflet has a corresponding holder 1 and positioner 2 to hold.

In addition, the present stent 100 may be cut using a nickel-titanium tube, but it should be noted that the material used may be any material that can be implanted into the human body and has high elasticity.

Although 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 alterations can be made therein without departing from the principles and spirit of the application, the scope of which is defined in the appended claims and their equivalents.

Claims

1. The aortic regurgitation support with the positioning piece being flexible comprises a retaining piece and the positioning piece, wherein the retaining piece is correspondingly provided with the positioning piece, and the outflow end of the positioning piece is fixedly connected with the outflow end of the retaining piece;

at least one positioning piece is controlled by a stay wire, the stay wire controls the opening angle of the positioning piece relative to the axis of the support in the compressed state of the support, and the positioning piece is opened to a position higher than the outflow end of the native valve leaflet under the stay wire control without the support backing.

2. The stent of claim 1, wherein the stent has an open angle in the range of 20 ° to 90 ° relative to the stent axis under control of the pull wire.

3. The stent of claim 2, wherein the inflow end of the stent reopens under control of a pull wire to capture the native valve leaflet a second time.

4. The flexible aortic regurgitation stent of claim 1, wherein the inner side of the inflow end of the stent is provided with a pull wire compound ring, the outflow end of the pull wire compound ring is provided with a pull wire hole, and the inflow end portion of the pull wire compound ring is used for developing.

5. The flexible aortic regurgitation stent of claim 4, wherein the pull wire composite ring comprises a connecting rod and a pull wire ring, wherein the inflow end of the connecting rod is fixedly connected with the inflow end of the positioning member, the outflow end of the connecting rod is fixedly connected with the pull wire ring, and the pull wire ring is provided with a pull wire hole.

6. The positioner pliable aortic regurgitation stent of claim 1, wherein the positioner and retainer have cooperating shapes that retain native leaflets of a heart valve between the positioner and retainer.

7. The stent of claim 1, wherein the diameter of the circle (O1) at the edges of the inflow end of the stent is smaller than the diameter of the circle (O2) at the edges of the middle portion of the inflow end of the stent.

8. The flexible aortic regurgitation stent of claim 1, wherein the outflow end of the positioning member is fixedly connected with a connecting portion, the connecting portion is configured to connect with a delivery system, the connecting portion comprises a connecting web, the inflow end of the connecting web is connected with the outflow end of the positioning member, the outflow end of the connecting web is connected with a connecting block, and the circumferential width of the connecting block is greater than the circumferential width of the connecting web.

9. The stent of any one of claims 1-8, wherein the inflow end of the holder is fixedly connected to the anchor, the inside of the holder is provided with a reinforcing support, the outflow end of the reinforcing support is connected to the holder, and the inflow end of the reinforcing support is connected to the anchor.

10. The stent of claim 9, wherein the anchoring portion is formed of circumferentially connected diamond-shaped mesh connections, the outflow end of the anchoring portion having a smaller diameter than the inflow end of the anchoring portion.

11. The flexible aortic regurgitation stent of any one of claims 1 to 8, wherein a stiffening member is disposed in the middle of the stent, and two ends of the stiffening member are respectively connected to inner sides of two sides of the stent.

12. The flexible aortic regurgitation stent of any one of claims 1 to 8, wherein the outflow end of the positioning member is fixedly coupled to the outflow end of the retainer by an extension rod, and wherein the extension rod is internally provided with leaflet suture holes for securing the outflow end of the artificial leaflet, the outflow end of the artificial leaflet being closer to the stent outflow end than the outflow end of the retainer.

13. The stent of any one of claims 1-8, wherein the inflow end portion of the retainer assumes a droplet-shaped configuration in the compressed state, the inflow end portion of the retainer assumes a U-shaped configuration in the expanded state, and the inflow end portion of the retainer assumes a droplet-shaped configuration in the compressed state.