CN115624416A

CN115624416A - Aorta regurgitation support that setting element is easily crooked

Info

Publication number: CN115624416A
Application number: CN202211391341.7A
Authority: CN
Inventors: 王春光; 耿肖肖; 郭应强; 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: 2023-01-20
Anticipated expiration: 2042-11-08
Also published as: CN218356471U; CN219000720U; CN115105259A; CN115624416B; CN116807686A; CN115381597A; CN117752468B; CN117752468A; CN115381598A; CN218792637U; CN116849869A; CN115105259B; CN116807685A; CN222566034U; CN116849871A; CN117752467A; CN117752467B; CN219000725U; WO2023184639A1; CN116807684A

Abstract

The application discloses an aorta reverse flow bracket with a flexible positioning piece, which relates to the technical field of medical instruments and comprises a plurality of holding pieces, a plurality of positioning pieces and anchoring parts, wherein one positioning piece is correspondingly arranged on the upper side of one holding 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 end that flows of setting element is wave line bending rod structure, and do benefit to the setting element and catch native valve leaflet, and need not the horizontal direction and remove the adjustment support, the operation degree of difficulty has been reduced, it sets up to wave line bending rod structure to flow the end through the setting element, the stability of the native valve leaflet of setting element centre gripping has been increased, the deformation range of the setting element end junction that flows has been reduced, reduce the injury of setting element inflow end to the aortic sinus end, the power of tearing that the stylolite is direct to artifical valve leaflet 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

Aorta counter-current support with flexible positioning part

The present application claims priority from chinese patent application 2022103159315 filed on 28.03.2022. The present application refers to the above-mentioned chinese patent application in its entirety.

Technical Field

The application relates to the technical field of medical equipment, in particular to an aortic regurgitation support with a flexible positioning piece.

Background

Since the way of performing surgery via a catheter has many advantages such as less trauma and fast recovery, more and more surgeries are beginning to be performed via a catheter. Aortic valve replacement was also changed from the earlier surgical approach to transcatheter aortic valve replacement.

Chinese patent publication No. CN102413793B entitled "stent for positioning and anchoring of a valve prosthesis at an implantation site in a heart of a patient" discloses an expandable stent, which requires aligning a plurality of positioning arches with a plurality of native aortic valve leaflets during implantation, inserting the positioning arches into the aortic sinus, and the number of beats of a person's lifetime can be as many as 20, and after the native aortic valve is replaced with a prosthetic heart valve, the prosthetic heart valve needs to withstand the impact from the blood flow in the aorta during diastole (left ventricular diastole), at which time the inflow ends of the positioning arches will impact the aortic sinus floor many times, and the positioning arches without a buffer structure will impact the aortic sinus floor rigidly, easily causing damage to the aortic sinus floor, and during the stent implantation, because the positioning arches are relatively straight structures, the flexibility of the positioning arches is relatively high, and during the implantation with poor positioning arches, deformation occurs mainly at the junctions of the positioning arches with the native valve, such as the pressure positioning arches, and the positioning arches of the positioning arches are easily damaged by the stress at the junctions of the positioning arches with the stent.

For this reason, it is desirable to provide a heart valve stent (regurgitation stent) which can be adapted for transcatheter aortic valve replacement and which is relatively flexible in positioning the arcs.

Disclosure of Invention

The utility model provides a flexible aorta regurgitation support of setting element to the problem that the location arc is not nimble enough among the prior art is directed against to this application to solve the problem that the location arc of regurgitation support is not nimble enough.

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

an aortic regurgitation bracket with a flexible positioning piece comprises a plurality of holding pieces, a plurality of positioning pieces and anchoring parts, wherein one positioning piece is correspondingly arranged on the upper side of one holding piece, the outflow end of each positioning piece is fixedly connected with the outflow end of the holding piece, and the inflow end of each holding piece is provided with the anchoring part;

wherein, the outflow end of the positioning piece is of a wavy line bending rod structure.

Preferably, the wavy wire bent rod structure is formed by alternating transverse U-shaped structural rods.

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

Preferably, a pull-wire composite ring is arranged on the inner side of the inflow end of the positioning member, a pull-wire hole is formed in the outflow end of the pull-wire composite ring, and the inflow end of the pull-wire composite ring is used for developing.

Preferably, the pull wire composite ring comprises a connecting rod and a pull wire ring, an inflow end of the connecting rod is fixedly connected with an inflow end of the positioning piece, an 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.

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

Preferably, the diameter of the circle (O1) on which the edges of the two sides of the inflow end of the positioning member are located is smaller than the diameter of the circle (O2) on which the edges of the middle part of the two sides of the inflow end of the positioning member are located.

Preferably, the outflow end of the positioning member is fixedly connected with the outflow end of the holding member through an extension rod, a leaflet suture hole is formed in the extension rod, the leaflet suture hole is used for fixing the outflow end of the artificial leaflet, and the outflow end of the artificial leaflet is closer to the support outflow end than the outflow end of the holding member.

Preferably, artificial valve leaflet includes the artificial valve leaflet main part and sets up in the artificial valve leaflet ear of artificial valve leaflet main part outflow end, the artificial valve leaflet ear passes the leaflet and sews up hole parcel extension rod, artificial valve leaflet main part inflow end edge is connected with the tectorial membrane, the tectorial membrane is installed in the support inboardly, and tectorial membrane outflow end is connected with the holder, and the tectorial membrane inflow end is connected in anchor portion, artificial valve leaflet main part inflow end edge is provided with the wear strip with tectorial membrane junction, the wear strip is folding structure, the cross section of wear strip is U type structure, artificial valve leaflet main part inflow end edge sets up in the folding inside the wear strip.

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

Preferably, the inflow end of the membrane everts from the inside of the stent to the outside of the stent to form an anchoring portion outer 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 are including connecting the web, the inflow end of connecting the web is connected with the outflow end of setting element, the outflow end of connecting the web is connected with the connecting block, the circumference width of connecting block is greater than the circumference width of connecting the web.

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

Preferably, the inlet end of the holder is fixedly connected to the anchor portion, the holder is internally provided with a reinforcing support portion, the outlet end of the reinforcing support portion is connected to the holder, and the inlet end of the reinforcing support portion is connected to the anchor portion.

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

Preferably, the anchoring portion is formed by circumferentially connected diamond-shaped mesh connections, and the diameter of the outflow end of the anchoring portion is smaller than the diameter of the inflow end of the anchoring portion.

Preferably, the stent comprises three retaining members connected circumferentially.

In contrast to the prior art, the present application provides an aortic regurgitation stent with a flexible spacer. The method has the following beneficial effects:

1. the opening angle of the positioning piece can be controlled by a pull wire: in the implantation process of the transcatheter regurgitation stent, the positioning piece is required to be used for capturing 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 retaining piece is positioned on the closed surface of the native valve leaflets, so as to clamp the native valve leaflets, however, the aortic valve leaflets generally consist of the three native valve leaflets, when the positioning piece captures all the native valve leaflets, the positioning piece which is easier can capture two of the native valve leaflets, and the three native valve leaflets can be captured at one time, but the three native valve leaflets are difficult to adjust relatively, because the three native valve leaflets surround a circle, each native valve leaflet is adjacent to each other and is difficult to adjust, and the native valve leaflets are movable, so that the three native valve leaflets can be captured at one time, the positioning piece can be controlled by at least one of the positioning piece, the opening angle of the positioning piece and the axis of the stent can be controlled by using the pull wire, the positioning piece can be opened at a larger angle by using the pull wire, so that the positioning piece can be closer to the non-closed surface of the native valve leaflets, thereby being beneficial to native valve leaflets, the native valve leaflets can be captured without moving and adjusting the positioning piece in the horizontal direction, the operation time can be saved, and the operation difficulty can be reduced.

2. The outflow end of the positioning piece is arranged into a wavy line bending rod structure: the setting element is when the native leaflet of centre gripping, the outflow end of setting element corresponds the outflow end of native leaflet, crooked structure has increased the area of contact of setting element and native leaflet, the effectual stability that increases the native leaflet of setting element centre gripping, secondly, when using the stay wire control setting element to open bigger angle, the deformation that the setting element was opened can be crooked by crooked structural component and open the setting element, the deformation range of setting element outflow end junction has been reduced, the damage that its deformation stress probably caused has been reduced, and finally, crooked structure also makes the setting element have certain elasticity in axial direction, when blocking blood palirrhea in diastole, can cushion the palirrhea impact force of blood, reduce the injury of setting element inflow end to aortic sinus floor.

3. Set up to folding structure through the abrasionproof strip and connect artificial valve leaf and tectorial membrane: set up artificial valve leaf main part inflow end edge in the folding inside the abrasionproof strip, the edge of artificial valve leaf main part is wrapped up completely, the effectual edge tear resistance who increases the artificial valve leaf main part, and when using the fixed artificial valve leaf of stylolite and tectorial membrane, only be located between artificial valve leaf and the tectorial membrane for its traditional abrasionproof strip, the effort that lies in the inboard (being close to support axis direction) suture line production of artificial valve leaf will direct action on artificial valve leaf, consequently, the effort that lies in the inboard (being close to support axis direction) suture line production of artificial valve leaf damages artificial valve leaf very easily, and folding, the abrasionproof strip of U type structure, wrap up the whole edge of artificial valve leaf main part completely, the power that the suture line produced acts on the abrasionproof strip completely, the direct tear power to artificial valve leaf of styled having reduced the suture line, the life of artificial heart valve has been improved, it works in the human body to do benefit to the artificial heart valve for a long time.

Drawings

The specific features of the invention to which this application relates are set forth in the appended claims. The features and advantages of the invention to which the present application relates will be better understood by reference to the exemplary embodiments and drawings described in detail below. The drawings are briefly described as follows:

FIG. 1 is a schematic view of a reflux scaffold and marker "according to an embodiment of the present application;

FIG. 2 is an expanded view of the reflux scaffold of FIG. 1;

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

FIG. 4 is a front view of a reflux shelf according to another embodiment of the present application;

FIG. 5 is a schematic view of the reflux shelf of FIG. 4;

FIG. 6 is a schematic view of the reflow frame and the C-shaped member of 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 part;

FIG. 9 is an expanded view of the reflux scaffold of FIG. 4;

FIG. 10 is an enlarged partial view of FIG. 9;

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

FIG. 12 is a schematic view of a reflux scaffold according to another embodiment of the present application;

FIG. 13 is an enlarged partial view of FIG. 12;

FIG. 14 is an expanded view of the reflux scaffold of FIG. 12;

FIG. 15 is a schematic view of a reflux scaffold 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 reflux scaffold of FIG. 15;

FIG. 18 is a schematic view of a reflux scaffold according to another embodiment of the present application;

FIG. 19 is an expanded view of the reflux scaffold of FIG. 18;

FIG. 20 is a deployment view of a reflux scaffold according to another embodiment of the present application;

FIG. 21 is a deployment view of a reflux scaffold according to another embodiment of the present application;

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

FIG. 23 is an enlarged partial view of FIG. 22;

fig. 24 is a schematic structural view of the artificial leaflet and the 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 a structure of an artificial leaflet, an abrasion-proof strip and a covering film according to the present application;

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

fig. 28 is a schematic structural view of a regurgitation scaffold, a coating film, an artificial leaflet according to the present application;

FIG. 29 is a schematic view of the structures of a regurgitation supporter, a covering membrane, an artificial leaflet, and an outer skirt in this application;

FIG. 30 is a schematic view of a regurgitation stent positioning element of the present application opened to align the native aortic valve leaflets in preparation for capture;

FIG. 31 is a schematic view of the positioning member of the stent in alignment with the native aortic valve leaflets and inserted into the aortic sinus of the subject application;

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 present application with the outer catheter removed from the distal portion of the delivery system;

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

Description of reference numerals:

100. a stent, 300, a delivery system distal end, 301, an outer catheter, 302, an inner catheter, 303, a sleeve, 304, a middle catheter, 30401, a groove, 1, a retainer, 2, a retainer, 201, a wavy wire curved rod structure, 3, a stiffener, 4, an extender, 401, a leaflet suture hole, 5, a connector, 501, a connecting web, 502, a connector block, 6, a stiffener support, 7, a pull wire composite ring, 701, a pull wire ring, 702, a connector rod, 703, a C-shaped member, 70301, a C-shaped outer sidewall, 70302, a C-shaped sidewall, 7C, a pull wire composite ring, 7C01, a marker insertion hole, 77, a pull wire hole, 8, an anchor, 9, a prosthetic leaflet, 901, a prosthetic leaflet body, 902, a prosthetic leaflet ear, 10, a cover film, 1001, an outer skirt, 11, a wear strip, a stress notch, 1101, a fold line, 11', a conventional wear strip, 1000, an inflow end, 2000, an outflow end.

Detailed Description

The following embodiments of the present application are described by specific examples, and other advantages and effects of the present application will be readily apparent to those skilled in the art from the disclosure of the present application. The present application is capable of other and different embodiments and its several details are capable of modifications and/or changes in various respects, all without departing from the spirit of the present application. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.

It should be noted that, in this document, 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. Also, 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. The term "comprising", without further limitation, means that the element so defined is not excluded from the group consisting of additional identical elements in the process, method, article, or apparatus that comprises the element.

It should be noted that, in this context, the height direction is substantially along the axis of the prosthetic heart valve, and except for the specific description as shown in the figures, the terms "high", "upper", "lower", and the like are directly mentioned herein, and the terms "high", "upper" and "lower" refer to positions close to the outflow end of the prosthetic heart valve in the expanded state (as shown in fig. 1), the terms "low" and "lower" refer to positions close to the inflow end of the prosthetic heart valve in the expanded state, the terms "inflow end" and "inflow end" refer to positions upstream in the direction of blood flow, i.e., the end of the stent that first passes through blood in the expanded state, such as the inflow end 1000 shown in fig. 4, and the terms "outflow end" and "refer to positions downstream in the direction of blood flow, i.e., the end of the stent that leaves the expanded state, such as the outflow end 2000 shown in fig. 4.

The application provides a technical scheme: an aortic regurgitation bracket with a flexible positioning piece comprises a plurality of retaining elements 1, a plurality of positioning elements 2 and anchoring parts 8, wherein a positioning piece is correspondingly arranged on the upper side of one retaining element, the outflow end of the positioning element 2 is fixedly connected with the outflow end of the retaining element 1, the inflow end of the retaining element 1 is provided with the anchoring parts 8, native valve leaflets are clamped between the retaining elements 2 and the retaining elements 1, and then the anchoring parts 8 are clamped on an aortic annulus, so that the regurgitation bracket is stably positioned at a native valve of the aorta;

as shown in fig. 12-14, the outflow end of the positioning element 2 is a wavy line curved rod structure 201, and the significant advantages brought by such an arrangement are three points, first, when the positioning element 2 clamps the native valve leaflet, the outflow end of the positioning element 2 corresponds to the outflow end of the native valve leaflet, that is, the free end of the native valve leaflet, the wavy line curved rod structure 201 increases the contact area between the positioning element 2 and the native valve leaflet, and effectively increases the stability of the positioning element 2 in clamping the native valve leaflet, and second, when the positioning element 2 is opened at a larger angle by using a pull wire to control the deformation of the positioning element 2, the positioning element 2 can be partially bent and opened by the wavy line curved rod structure 201, so as to reduce the deformation amplitude at the outflow end connection of the positioning element 2, reduce the damage to the outflow end connection of the positioning element 2 due to the deformation stress, and finally, the wavy line curved rod structure 201 also makes the positioning element 2 have certain elasticity in the axial direction, and when blood backflow is blocked in the diastole, the impact force caused by the inflow end of the positioning element 2 can be buffered, and the injury to the aortic sinus floor of the aortic sinus.

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 range of the wavy-line bent rod structure 201 is relatively large, such as an S-shape, or the wavy-line bent rod structure 201 formed by the transverse U-shaped structural rods alternately can effectively increase the elasticity of the positioning member 2 in the axial direction.

In some embodiments, during the transcatheter stent implantation, the positioning element 2 is required to capture the native leaflets, i.e. the positioning element 2 is required to be inserted into the non-closed surface of the native leaflets, and the retaining element 1 is located on the closed surface of the native leaflets, so that the retaining element 1 and the positioning element 2 clamp the native leaflets, but since the native aortic leaflets generally consist of three native leaflets (as shown in fig. 34), the positioning element 2 generally has at least three positioning elements corresponding to all the native leaflets to be captured, an easier positioning element 2 can capture two of the native leaflets, and capture three of the native leaflets at one time is relatively difficult, since the three native leaflets enclose a circle, when the positioning element 2 and the native leaflets are aligned, when the stent 100 is moved in the horizontal (vertical to the axis of the stent 100), there must be native leaflet non-closed surfaces that the positioning element 2 is far away from and close to, and when the native leaflets are also movable under the effect of blood, it is important to capture the timing, so that all the positioning elements 2 capture three native leaflets at one of the leaflet at one positioning element 2 at a time is relatively difficult to capture the native leaflets, so that the positioning element 2 can be more easily moved in the direction of the opening of the native leaflets, and the positioning element 2 can be more easily controlled by the positioning element 100, so that the positioning element 2 can be moved in the horizontal (vertical direction, and the positioning element 100) to control the angle of the native leaflets can be more easily opened stent, so that the positioning element 2 is more easily controlled by the positioning element 2;

here, at least one of the positioning elements 2 is controlled by a pulling wire, the openable angle range of the positioning element 2 relative to the axis of the support 100 under the control of the pulling wire is 20 ° to 60 °, for example, 21 °, 23 °, 25 °, 28 °,30 °, 33 °, 35 °, 38 °,40 °, 43 °, 45 °, 48 °,50 °, 53 °, 55 °, 58 °, 60 °, and when the positioning element 2 catches or aligns with the non-closed surface of the native valve leaflet, the support 100 does not need to be moved horizontally, a larger radial outward extension size can be obtained by opening the positioning element 2 by a larger angle, and the positioning element 2 aligns with the native non-closed surface of the native valve leaflet, so that the positioning element 2 of the support 100 catches the native valve leaflet smoothly;

further, the positioning element 2 can be opened at an angle ranging from 60 ° to 90 ° relative to the axis of the stent 100 under the control of the pulling wire, wherein a larger angle, for example, close to 90 °, is opened, and another main purpose of the positioning element 2 is to remedy the failure of capturing the native leaflets, namely, although the positioning element 2 is opened at a larger angle (as shown in fig. 30) before capturing the native leaflets by the pulling wire control to facilitate capturing the native leaflets, and then the positioning element 2 is pushed into the non-closed surface of the native leaflets (as shown in fig. 31) to move the stent 100 towards the ventricle, but because, for example: the native valve leaflet is moved in the pushing process of the positioning element 2, the angle of the imaging device is not good, the development is not clear, and the like, which causes observation errors and other reasons, so that the positioning element 2 is not successfully inserted into the non-closed surface of the native valve leaflet, the traditional support 100 which can not control the opening angle of the positioning element 2 only can retreat the support 100, namely the positioning element 2 is withdrawn from the non-closed surface of the native valve leaflet to capture the native valve leaflet again, now the positioning element 2 can be opened by a large angle, such as 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 support 100 is not retreated, the inflow end of the positioning element 2 which is not inserted into the non-closed surface of the native valve leaflet is opened to a position higher than the outflow end of the native valve leaflet which is not captured, put down setting element 2 again, realized the secondary catching to native valve leaflet, because support 100 is in the state of compression this moment, consequently have sufficient space to open setting element 2 in the aorta, although the inflow end of possible setting element 2 can touch the aorta wall, but its duration is short, the later stage is no longer opened promptly, setting element 2 inflow end no longer touches the aorta wall, and open under support 100 is in the state of compression, it can not form too big support 100 horizontal outline size to open setting element 2 under support 100 compression state promptly, can not produce great power to the aorta wall promptly, consequently setting element 2 can open relatively great angle and carry out the secondary catching to native valve leaflet under the control of acting as go-between.

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-string composite ring 7C, where the inner side of the inflow end of the positioning member 2 refers to the upper side surface of the positioning member 2, and since the positioning member 2 is a structure similar to a V shape as a whole, and the concave side (i.e., the upper side surface) is the inner side thereof, it is obvious that the position of the pull-string composite ring 7C is clearly shown in fig. 1-3, and since the positioning member 2 needs to capture native valve leaflets, the position of the inflow end of the positioning member 2 is particularly important, and in order that the position of the inflow end of the positioning member 2 can be clearly displayed on the imaging device, the inflow end portion of the pull-string composite ring 7C is used for visualization, and the embodiment is provided that the marking insertion hole 7C01 is opened at the inflow end of the pull-string composite ring 7C, and a marker "is embedded in the marker embedding hole 7C01, so as to facilitate the precise positioning and implantation of the positioning member 2, ensure that the positioning member 2 can accurately catch the native valve leaflets and insert into the sinus floor, while the outflow end of the pull wire composite ring 7C is provided with a pull wire hole 77, the pull wire hole 77 is used for passing through a pull wire, the pull wire controls the positioning member 2 to open a larger angle through the pull wire hole 77, so as to facilitate the positioning member 2 to catch the native valve leaflets and reduce the operation difficulty, and meanwhile, the structure of the pull wire composite ring 7C arranged at the inflow end of the positioning member 2 combines the pull wire control and the development function into one position (the pull wire composite ring 7C), so as to effectively improve the space utilization rate of the product, it should be noted that, although the pull wire composite ring 7C is in the shape of a gourd in fig. 1-3, the shape includes but is not limited to the shape of a gourd, the stay wire composite ring 7C can be in a rectangular shape, a triangular shape, an oval shape and the like, and can also have a function of assisting recognition by adopting a specific shape, for example, the stay wire composite ring can be in a gourd shape, a rectangular shape, a triangular shape, an oval shape and the like in an image device, so that the observation is facilitated.

In some embodiments, as shown in fig. 4-8, by embedding a marker "into a marker insertion hole 7C01 at the inflow end of a pull-wire composite ring 7C (shown in fig. 1), such an arrangement can achieve the visual positioning of the inflow end of the positioning member 2, but is limited by the size of the marker insertion hole 7C01 at the inflow end of the pull-wire composite ring 7C (shown in fig. 1), which results in a small volume of the marker", which is not conducive to the visual observation during visualization or difficult to observe due to the small volume of the marker ", wherein to increase the visualization function of the pull-wire composite ring 7, the pull-wire composite ring 7 includes a connecting rod 702 and a pull-wire ring 701, a C-shaped member 703 is mounted on the connecting rod 702, wherein the C-shaped member 703 is made of radiopaque metal, which can present a clear image under the visualization device, and because the C-shaped member 703 is wrapped on the connecting rod 702, as shown in fig. 8, the C-shaped component 703 is a component with a cross section similar to a C-shape, the opening of the C-shaped component can be opened and closed for being mounted on the connecting rod 702, where one side of the C-shaped component 703 away from the axial direction of the bracket 100 is a C-shaped outer side wall 70301, and the side walls thereof clamped at both sides of the connecting rod 702 in the circumferential direction are C-shaped two side walls 70302, in order to reduce the unevenness of the outer surface of the pull wire composite ring 7 caused by the C-shaped component 703, the thickness of the C-shaped outer side wall 70301 is smaller than the thickness of the C-shaped two side walls 70302, since the C-shaped component 703 is wrapped on the connecting rod 702, the volume of the C-shaped component 703 is relatively large, which is more convenient for observation and reduces the difficulty for observation, the inflow end of the connecting rod 702 is fixedly connected with the inflow end of the positioning element 2, the outflow end of the connecting rod 702 is fixedly connected with the pull wire ring 701, and the maximum outline size of the pull ring 701 is larger than the width (circumferential) size of the connecting rod 702 Thereby preventing the C-shaped part 703 from slipping off the connecting rod 702, and firmly limiting the C-shaped part 703 between the inner side of the inflow end of the positioning part 2 and the pull wire ring 701, wherein the pull wire ring 701 is provided with a pull wire hole 77, the pull wire hole 77 is used for passing a pull wire, and the opening of the positioning part 2 at a larger angle is controlled by the pull wire through the pull wire hole 77.

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 cooperating shapes, that is, the positioning member 2 has a shape substantially 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, so that the native leaflets can be effectively and firmly fixed due to the fact that the positioning member 2 has a shape substantially the same as that of the retaining member 1.

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, during diastole, that is, the left ventricle is in a diastolic state, at which the aortic valve (the artificial heart valve/support 100) is closed to prevent blood from flowing back to the heart from the inside of the aorta, the artificial heart valve needs to bear 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 be pressed down to 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 relatively flattened, and the contact area between the inflow end of the positioning member 2 and the bottom of the aortic sinus is increased, so that the diameter of the circle (O1) where the edges of the two sides of the inflow end of the positioning member 2 are located is smaller than the diameter of the circle (O2) where the edge of the middle portion of the two sides of the inflow end of the positioning member 2 is located, and further, the inflow end of the positioning member 2 can be wrapped, for example, the inflow end of the positioning member 2 is made of a material the positioning member 9, so as to form a relatively soft inflow end of the positioning member 2.

In some embodiments, the middle part of the positioning element 2 is provided with the reinforcing element 3, the setting of the reinforcing element 3 effectively increases the contact area between the positioning element 2 and the native valve leaflet, the two ends of the reinforcing element 3 are respectively connected to the inner sides of the two sides of the positioning element 2, in this embodiment, the reinforcing element 3 is a V-shaped structure, the compression and expansion of the reinforcing element 3 can be realized, the joint of the two ends of the reinforcing element 3 and the positioning element 2 is relatively close to the outflow end part of the positioning element 2, the circumferential supporting force of the outflow end of the positioning element 2 is also effectively increased, and the stability of the whole support 100 is increased.

In some embodiments, each individual is an independent individual, so that the aortic valve has slight difference, and therefore, the outflow end of the positioning member 2 is fixedly connected with the outflow end of the holding member 1 through the extension rod 4, so that the adjustment capability of the positioning member 2 relative to the holding member 1 is increased, the length of the whole stent 100 can be adjusted to a certain extent, and the stent can adapt to wider crowds;

further, in order to increase the closing performance of the outflow end of the artificial leaflet 9, a leaflet suture hole 401 is disposed inside the extension rod 4, the leaflet suture hole 401 is used for fixing the outflow end of the artificial leaflet 9, the outflow ends of adjacent artificial leaflets 9 are closely combined and attached together through the leaflet suture hole 401, and backflow of blood through the closed part of the outflow end of the artificial leaflet 9 is effectively prevented, as shown in fig. 28, by disposing the extension rod 4, the outflow end of the artificial leaflet 9 is matched with the extension rod 4 to form a closed interval of the outflow end of the artificial leaflet 9, which is longer in the axial direction, so as to increase the sealing performance between the artificial leaflets 9, because the extension rod 4 is disposed on the upper side of the outflow end of the holder 1, the outflow end of the artificial leaflet 9 is closer to the outflow end of the holder 100 than the outflow end of the holder 1, so that the closed interval of the end of the artificial leaflet 9 is also located at a position closer to the outflow end of the holder 100 than the outflow end of the holder 1, thereby effectively extending the axial direction length of the artificial leaflet 9, preventing the closed interval of the artificial leaflet 9 from being relatively short in the axial direction, and thus preventing the axial direction from affecting the outflow interval of the artificial leaflet 9, and reducing the length of the artificial leaflet 9.

In some embodiments, as shown in fig. 24-29, the artificial leaflet 9 includes an artificial leaflet body 901 and an artificial leaflet ear 902 disposed at the outflow end of the artificial leaflet body 901, the artificial leaflet ear 902 wraps the extension rod 4 through the leaflet suture hole 401, the inflow end edge of the artificial leaflet body 901 is connected with a cover film 10, the cover film 10 is mounted inside the stent 100, the outflow end of the cover film 10 is connected with the holder 1, the inflow end of the cover film 10 is connected with the anchor portion 8, the inflow end edge of the artificial leaflet body 901 is connected with the cover film 10 and is provided with a wear strip 11, the wear strip 11 is disposed to firstly increase the tear resistance of the inflow end of the artificial leaflet 9 and secondly reduce the friction between the inflow end of the artificial leaflet 9 and the cover film 10 to damage the artificial leaflet 9, thereby increasing the service life of the artificial leaflet 9, and the wear strip 11 is also disposed to be equivalent to a buffer layer between the artificial leaflet 9 and the cover film 10, thereby effectively buffering the tearing force of the artificial leaflet 9 on the cover film 10 during the opening and closing process, thereby increasing the service life of the artificial heart valve; further, the wear-resistant strip 11 is designed as follows, the wear-resistant strip 11 is a folded structure, that is, the cross section of the wear-resistant strip 11 is a U-shaped structure, the inflow end edge of the artificial leaflet main body 901 is arranged inside the folded wear-resistant strip 11, so as to completely wrap the edge of the artificial leaflet main body 901, which effectively increases the tear resistance of the edge of the artificial leaflet main body 901, and when the artificial leaflet 9 and the covering film 10 are fixed by using the suture, compared with the conventional wear-resistant strip 11 '(as shown in fig. 26), the conventional wear-resistant strip 11' is only located between the artificial leaflet 9 and the covering film 10, so that the force generated by the suture located inside the artificial leaflet 9 (close to the axial direction of the stent 100) will directly act on the artificial leaflet 9, and when the artificial leaflet 9 is subjected to an impact of blood, the joint between the artificial leaflet main body 901 and the covering film 10 will be subjected to a certain tearing, so that the force generated by the suture located inside the artificial leaflet 9 (close to the axial direction of the stent 100) can easily damage the artificial leaflet 9, causing the artificial leaflet 9, and further the whole artificial valve to fail (but it is not limited to the wear-resistant strip 11, and the life of the artificial leaflet can be completely reduced by the wear-resistant strip 11, and the life of the artificial leaflet can be improved when the artificial leaflet 9 is directly used in the folded artificial leaflet.

In some embodiments, as shown in fig. 25, since the edge of the artificial leaflet 9 is curved, when the wear strip 11 is folded, a phenomenon of material overlapping due to squeezing may occur, and 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 phenomenon of material overlapping due to squeezing when the wear strip 11 is folded, where the stress notches 1101 may be disposed on the outer side of the folding line 1102 or on the inner side of the folding line 1102, and further, the material of the wear strip 11 on both sides of the folding line 1102 may be an integral structure, or may be formed by connecting different materials at the folding line 1102 by sewing, gluing, or the like.

In some embodiments, in order to reduce the friction damage between the wear strip 11 and the artificial leaflet 9 and ensure that the wear strip 11 has the same mechanical properties as the artificial leaflet 9 as much as possible, so as to ensure that the artificial leaflet 9 has better opening and closing stability, the wear strip 11 is made of the same material as the artificial 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 with the aortic annulus for limiting the displacement of the stent 100 in the axial direction away from the left ventricle, the anchoring portion 8 may contact with the aortic annulus frequently, and in order to reduce damage to the valve caused by the anchoring portion 8 of the stent 100 leaking from the inside of the stent 100, the inflow end of the cover film 10 is everted 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, further, the outer skirt 1001 may be formed by laser cutting or otherwise forming a strong and durable material, such as braided PET, or other synthetic or natural materials, and the outer skirt 1001 may be integrated with the cover film 10 or may be connected to the cover film 10 by sewing, gluing, or the like.

In some embodiments, the artificial leaflet 9 can comprise one or more synthetic materials, engineered biological tissues, biological leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, chemically or biologically processed/treated tissues, or combinations thereof, in some embodiments, pericardial tissues are selected from the group consisting of, but not limited to, bovine, equine, porcine, ovine, and human tissues, or combinations thereof.

In some embodiments, in order to facilitate the delivery of the stent 100 by a better delivery device, 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 facilitate the delivery of the better delivery device, the connecting portion 5 comprises 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 such design of the connecting portion 5, the connection separation of the distal end 300 of the delivery system from the outflow end of the stent 100 can be facilitated, 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 manipulated by a user) is described in conjunction with fig. 32 and fig. 33, the delivery system is in a compressed state during the delivery process, the distal end 300 of the delivery system comprises an outer catheter 301, the outer catheter 301 is provided with a middle catheter 304 inside, the distal end of the middle catheter 304, the distal catheter 304 is provided with a groove 30401 matched with the connecting portion 5 of the stent 100, the groove 30401 matched with the width of the connecting portion 100 in the connecting portion 5 in the circumferential direction, so that the connecting portion 300 can not be limited by the inner groove 30401 in the inner groove 30401 of the connecting portion 100, and the connecting portion 302 of the connecting catheter 100, so that the connecting portion 302 of the connecting portion 100 can be in the inner groove 30401, the connecting portion 100, and the inner groove 30401 can be in the inner groove 30401, so that the inner groove 30401 of the connecting portion 100 can be limited by the inner groove 30401, the sleeve 303 is connected to the distal end of the inner catheter 302, 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 positioning member 2, the reinforcing member 3, and the like, inside the sleeve 303, 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, when the stent 100 is released, the inner catheter 302 and the sleeve 303 are pushed forward, 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 moved backward, so that the positioning member 2 is released from the sleeve 303, the positioning member 2 is aligned with native aortic valve leaflets, 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 valve leaflets, i.e., the positioning member 2 is inserted into the sinus again, the inner catheter 302 and the sleeve 302 are pushed forward, so that the stent 100 is completely released, and the stent 100 is pulled out of the stent 100 in the radial direction, and the stent 100 is pulled out of the stent delivery groove 300, and the stent delivery groove 300 is completely, so that the stent delivery end covers the stent delivery system, and the stent delivery end is completely, and the stent delivery end is withdrawn from the stent delivery groove 300, and the stent delivery end is fully released, and the stent delivery end is fully extended stent delivery resistance of the stent delivery groove 300, and the stent delivery groove 300 is released, and the stent delivery groove 300 is fully released, and the stent delivery system 100 is fully withdrawn from the stent delivery groove 300, and the stent delivery is fully withdrawn from the stent delivery system 100.

In some embodiments, since the inflow end of the holder 1 is relatively close to the anchoring portion 8, when the stent 100 is expanded, that is, when the stent 100 works in the heart, the heart is in a diastole (left ventricle diastole), and blood in the aorta will impact against the artificial leaflet 9 in a reverse direction, and at this time, the blood may regurgitate along the gap between the native aortic leaflet 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 there is no covering film 10 on the upper portion of the holder 1, and the possibility of regurgitation is high, as shown in fig. 22 and 23, the inflow end of the holder 1 is in a water-drop configuration in a compressed state, and the inflow end of the holder 1 is in a U-shape configuration in an expanded state, so that the size of the opening at the inflow end of the holder 1 when the stent 100 works is greatly reduced, the blood regurgitation through the inflow end of the holder 1 is effectively prevented from occurring, or the blood regurgitation is allowed to be in a range, and a large amount of regurgitation phenomenon does not occur through the inflow end of the holder 1, as shown in fig. 22 and fig. 23, the aortic leaflet 2 is designed to be more easily caught in a state of the native aortic valve 2, and the aortic valve is more easily to be matched with the native aortic valve 2 in the native valve.

In some embodiments, as shown in fig. 5, the inflow end of the holder 1 is fixedly connected with the anchoring portion 8 to form a relatively stable structure, and further, a reinforcing support portion 6 is disposed inside the holder 1, the outflow end of the reinforcing support portion 6 is connected with the holder 1, the inflow end of the reinforcing support portion is connected with the anchoring portion 8, the reinforcing support portion 6 mainly functions to increase the circumferential supporting force of the stent 100 and provide a fixing point for the membrane 10 of the stent 100, further, as shown in fig. 18-21, the reinforcing support portion 6 may be formed by several single links without crossing structure, for example, by two links or four links (as shown in fig. 18 and 19), or by forming the reinforcing support portion 6 by diamond-shaped mesh after forming the diamond-shaped mesh by several links crossing structure (as shown in fig. 20), or by combining both (as shown in fig. 21), and further, the reinforcing support portion 6 may have one or more connection 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, the holder 1 is connected to the anchoring portion 8 through the reinforcing support portion 6, such that the anchoring portion 8 is not directly connected to the holder 1, thereby providing the anchoring portion 8 with a certain flexibility relative to the holder 1 and improving the applicability thereof, and the reinforcing support portion 6 mainly serves to connect the anchoring portion 8 to the holder 1 and also to increase the circumferential supporting force of the stent 100 and to provide a fixing point for the cover 10 of the stent 100.

In some embodiments, as shown in fig. 18, the anchoring portions 8 are formed by diamond-shaped mesh connections connected in the circumferential direction, which maintains the compression performance of the anchoring portions 8, and further, the anchoring portions 8 may also be of polygonal line structures or other structures capable of compressing and expanding, and the diameter of the outflow end of the anchoring portions 8 is smaller than that of the inflow end of the anchoring portions 8, so that the anchoring portions 8 form a structure in which the inflow end of the anchoring portions 8 is expanded outward relative to the outflow end of the anchoring portions 8, so that the anchoring portions 8 can firmly contact with the valve annulus, thereby restricting the stent 100 from moving away from the heart in the axial direction.

In some embodiments, as shown in fig. 34, the native aortic valve leaflet of a human is generally composed of three native valve leaflets, and the corresponding stent 100 comprises three retaining elements 1 connected circumferentially and three positioning elements 2, so that each native valve leaflet has the corresponding retaining element 1 and positioning element 2 to clamp.

In addition, the stent 100 can be made by cutting a nickel titanium tube, but it should be noted that the material used can be any material that can be implanted into the human body and has elasticity.

Although embodiments of the present application have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and alterations can be made in these embodiments 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. An aortic regurgitation bracket with a flexible positioning piece comprises a plurality of holding pieces, a plurality of positioning pieces and anchoring parts, wherein one positioning piece is correspondingly arranged on the upper side of one holding piece, the outflow end of each positioning piece is fixedly connected with the outflow end of the holding piece, and the inflow end of each holding piece is provided with the anchoring part;

wherein, the outflow end of setting element is wave line bending rod structure.

2. The flexible retainer aortic regurgitation support of claim 1 wherein the undulating wire curved bar structures are formed by alternating transverse U-shaped structural bars.

3. An aortic regurgitation stent having flexible positioning members as claimed in claim 1 or claim 2 wherein at least one of the positioning members is controlled by a pull wire, and the positioning member is openable by the pull wire through an angle in the range of 20 ° to 90 ° with respect to the axis of the stent.

4. The flexible aortic regurgitation stent of claim 3 wherein the inner side of the inflow end of the positioning member is provided with a composite pull wire ring, the outflow end of the composite pull wire ring is provided with a pull wire hole, and the inflow end of the composite pull wire ring is used for visualization.

5. The flexible retaining member aortic regurgitation stent of claim 4, wherein the pull wire complex ring comprises a connecting rod and a pull wire ring, the inflow end of the connecting rod is fixedly connected with the inflow end of the retaining 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 flexible retainer aortic regurgitation stent of claim 1 wherein the retainer and the retaining member have cooperating shapes to retain the native leaflets of the heart valve between the retainer and the retaining member.

7. The aortic regurgitation stent having the easily bendable spacer as set forth in claim 1, wherein the diameter of the circle (O1) on which the edges of the inflow end of the spacer are located is smaller than the diameter of the circle (O2) on which the edges of the middle portion on both sides of the inflow end of the spacer are located.

8. The flexible retaining member aortic regurgitation stent of any one of claims 1 to 7 wherein the retaining member has an outflow end fixedly connected to the outflow end of the retaining member by an extension rod, the extension rod having a leaflet suture hole formed therein for securing the outflow end of the artificial leaflet positioned closer to the stent outflow end than the outflow end of the retaining member.

9. The flexible aortic regurgitation support of claim 8, wherein the artificial leaflet comprises an artificial leaflet main body and artificial leaflet ears arranged at the outflow end of the artificial leaflet main body, the artificial leaflet ears pass through the leaflet suture holes to wrap the extension rod, the inflow end edge of the artificial leaflet main body is connected with the covering membrane, the covering membrane is arranged inside the support, the outflow end of the covering membrane is connected with the retaining element, the inflow end of the covering membrane is connected with the anchoring part, an abrasion-proof strip is arranged at the joint of the inflow end edge of the artificial leaflet main body and the covering membrane, the abrasion-proof strip is of a folding structure, the cross section of the abrasion-proof strip is of a U-shaped structure, and the inflow end edge of the artificial leaflet main body is arranged inside the folding abrasion-proof strip.

10. The flexible retainer aortic regurgitation support of claim 9 wherein the folded section of the wear strip is provided with 3-10 stress notches.

11. The flexible retainer aortic regurgitation stent of claim 9 wherein the inflow end of the membrane everts from the inside of the stent to the outside of the stent forming an anchoring outer skirt.

12. The flexible retaining member aortic regurgitation stent of claim 1 wherein the outflow end of the retaining member has a connecting section fixedly attached thereto for connection with a delivery system, the connecting section including a connecting web, the inflow end of the connecting web being connected to the outflow end of the retaining member, the outflow end of the connecting web having a connecting block attached thereto, the connecting block having a circumferential width greater than the circumferential width of the connecting web.

13. The flexible retainer member aortic reflux stent as set forth in any one of claims 1-12, wherein the inflow end portion of the retention member assumes a drop-shaped configuration when in a compressed state, the inflow end portion of the retention member assumes a U-shaped configuration when in an expanded state, and the inflow end portion of the retainer member assumes a drop-shaped configuration when in a compressed state.

14. The aortic regurgitation stent having a flexible retainer in accordance with claim 1, wherein the retaining member has an inflow end fixedly connected to the anchoring portion, and the retaining member has a reinforcing support portion provided therein, and 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.

15. The aortic regurgitation stent of claim 14 wherein the inflow end of the retaining member is free of attachment to the anchoring portion and the retaining member is attached to the anchoring portion by a stiffening support portion.

16. A flexible aortic reflux stent as set forth in any one of claims 1, 14 or 15, wherein the anchoring portions are formed by circumferentially connected diamond-shaped mesh connections, the diameter of the outflow end of the anchoring portions being smaller than the diameter of the inflow end of the anchoring portions.

17. The flexible retainer aortic regurgitation stent of any one of claims 1-16 wherein the stent includes three retaining members connected circumferentially.