CN115252222A

CN115252222A - Transcatheter valve replacement device and stent thereof

Info

Publication number: CN115252222A
Application number: CN202210771183.1A
Authority: CN
Inventors: 韦承涛; 陈晓; 张旭东; 陈晟达; 吴维; 刘冰冰; 张铭宇
Original assignee: Shanghai Hanling Medical Devices Co ltd
Current assignee: Shanghai Hanling Medical Devices Co ltd
Priority date: 2022-06-30
Filing date: 2022-06-30
Publication date: 2022-11-01

Abstract

The invention provides a transcatheter valve replacement device and a stent thereof, relating to the technical field of heart valves. A transcatheter replacement valve stent includes a stent body and an anchoring structure. The stent main body is a cylindrical frame structure which can be radially compressed and expanded and has a pressing and holding state and an expanding state; the anchoring structure is arranged on the outer ring of the bracket main body around the bracket main body in a circle and is suitable for anchoring the bracket main body; the anchoring structure at least partially overlaps the stent body in a radial direction when the stent body is in a crimped state, such that the transcatheter replacement valve stent forms a double-layered frame structure when crimped. The invention can solve the problem of difficult bending adjustment in a narrow space in the process of conveying the replacement valve stent in the prior art, can shorten the length of the replacement valve stent after being pressed and held, and has short length of the bending adjustment sheath tube, so that the replacement valve stent can avoid a bending part with a larger angle in the process of releasing in the narrow space, and the bending adjustment sheath tube is easier to bend.

Description

Transcatheter valve replacement device and stent thereof

Technical Field

The invention relates to the technical field of heart valves, in particular to a transcatheter valve replacement device and a stent thereof.

Background

Transcatheter Mitral Valve Replacement (TMVR) does not require thoracotomy, cardiac arrest, and extracorporeal circulation, greatly reducing surgical trauma, and becoming a further research hotspot following Transcatheter Aortic Valve Replacement (TAVR). The replacement valve needs a large-angle bending after puncture of the ventricular septum, and the replacement operation can be performed perpendicular to the plane of the mitral valve. However, the size of the left ventricle space of a human body is different not only in different disease courses, but also in individuals of different people, and in the existing mitral valve replacement valve stent delivery process, the defects of difficult bending adjustment and higher requirements on the mechanical strength and performance of the bending adjustment sheath of the delivery system exist in the narrow space of the left ventricle.

Disclosure of Invention

The invention aims to solve the technical problem of overcoming the defect of difficult bending adjustment in a narrow space in the delivery process of a replacement valve stent in the prior art, thereby providing a transcatheter replacement valve device and a stent thereof.

To address the above-mentioned problems, one aspect of the present invention provides a transcatheter replacement valve stent comprising a stent body and an anchoring structure. The stent main body is a cylindrical frame structure which can be radially compressed and expanded and has a pressing and holding state and an expanding state; the anchoring structure is arranged around the periphery of the bracket main body; when the stent main body is in a press-holding state, at least part of the anchoring structure is overlapped with the stent main body in the radial direction, so that the transcatheter replacement valve stent forms a double-layer frame structure when being pressed and held; in the deployed state of the stent body, the anchoring structure expands toward the outside of the stent body to anchor the stent body.

Optionally, the anchoring structure includes a plurality of anchors spaced around the periphery of the bracket body, the anchors have a fixed end and a free end, and the fixed end is connected to the bracket body; in the deployed state of the stent body, the free ends expand radially outward of the stent body and are adapted to provide a radial anchoring force to the stent body.

Optionally, the anchor comprises an anchor rod comprising a first rod segment, a second rod segment, and an intermediate rod segment connecting the first rod segment and the second rod segment; the intermediate lever section is the pole of bending, and the first end of first pole section, second pole section all is connected with the first end of support main part and constitutes the stiff end, and the second end of first pole section, second pole section all extends towards the second end of support main part along the axial to connect through the intermediate lever section and be closed loop construction, the intermediate lever section constitutes the free end.

Optionally, the outer contour of the bending point of the middle rod segment is a rounded arc.

Optionally, at least half of the number of the intermediate rod segments of the plurality of anchoring rods are bent radially closer to or further away from the stent body to prevent puncturing of myocardial tissue.

Optionally, the first rod segment includes a first bending portion and a second bending portion sequentially arranged from the first end to the second end, the first bending portion is convexly curved along a radial direction close to the support body, and the second bending portion is convexly curved along a radial direction away from the support body; the second pole segment is structurally identical to the first pole segment.

Optionally, the fixed end is connected to the first end of the stent body, and the free end extends towards the second end of the stent body, so that when the stent body is in the crimped state, at least one of the stent body and the anchoring structure is completely overlapped with the other in the radial direction.

Optionally, still include the pannier structure, the pannier structure sets up around the periphery of support main part, and the support main part is in under the expansion state, and anchoring structure and the cooperation of pannier structure for the centre gripping autologous leaflet.

Optionally, the apron strut structure is annular frame structure, and the inner circle of apron strut structure is connected with the second end of support main part, and the outer lane of apron strut structure expands towards the outside of support main part.

Optionally, the skirt strut structure includes the first skirt strut section of being connected with the support main part and the second skirt strut section of being connected with first skirt strut section, and the support main part is crooked to be kept away from along support main part radially to first skirt strut section, and the support main part is crooked to be close to along support main part radially to the second skirt strut section and sets up.

Optionally, a grid opening is arranged between the first apron supporting section and the bracket main body or between the first apron supporting section and the second apron supporting section, and the free end extends into the grid opening.

Optionally, a reinforcing structure is connected between two adjacent anchors.

Optionally, the reinforcing structure includes a reinforcing rod, the reinforcing rod is a combination of one or more of V-shaped, U-shaped and W-shaped, and two ends of the reinforcing rod are respectively connected to two adjacent anchors.

Optionally, the second end of the stent main body is provided with a conveying connection structure, the conveying connection structure comprises a plurality of connecting rods arranged around the stent main body at intervals, one ends of the connecting rods are connected with the second end of the stent main body, the other ends of the connecting rods extend along the axial direction of the stent main body away from the second end of the stent main body, and a hanging part is arranged at the end part and is suitable for being connected with a conveying system.

Optionally, the stent main body is provided with a plurality of leaflet suture ears around the circumference of the stent main body.

Another aspect of the present invention provides a transcatheter replacement valve device comprising the transcatheter replacement valve stent of any one of the above aspects.

Optionally, the support main part has the skirt strut structure, and the structural sealed skirt cloth that is connected with of skirt strut, sealed skirt cloth locate the inboard of support main part around support main part round laminating ground, and the first end and the skirt strut structural connection of sealed skirt cloth, the second end of sealed skirt cloth extends towards the first end of support main part.

Optionally, the transcatheter replacement valve stent further comprises a leaflet suture ear, the second end of the sealing skirt partially or completely covering the leaflet suture ear.

Optionally, the transcatheter replacement valve stent further comprises a leaflet suture ear, and the inner side of the stent main body is positioned at the leaflet suture ear and is connected with a prosthetic valve in a suture way; the artificial valve is provided with two pieces which are suitable for replacing the mitral valve of a patient; or, the artificial valve is provided with three pieces and is suitable for replacing the aortic valve of the patient; or, the artificial valve is provided with four pieces, which is suitable for the heart valve of a special patient.

The invention has the following advantages:

1. by utilizing the technical scheme of the invention, because the bracket main body is in a pressing and holding state, at least part of the anchoring structure is overlapped with the bracket main body in the radial direction, compared with the existing replacement valve bracket, the length of the replacement valve bracket after being pressed and held can be shortened, so that the length of the bending sheath tube occupied in the conveying system is short, the replacement valve bracket can avoid a bending part with a larger angle in the release process in a narrow space, the bending sheath tube is easier to bend, and the mechanical strength and performance requirements on the bending sheath tube of the conveying system are reduced.

2. In the crimping state, at least one of the stent main body and the anchoring structure is completely overlapped with the other in the radial direction, so that the axial length of the crimped valve replacement stent through the catheter can be shortened to the maximum extent, and the bending difficulty of the bending sheath tube is further reduced in the conveying process.

3. The first rod section and the second rod section of the anchoring rod are connected into a closed-loop structure through the middle rod section, so that the strength of the anchoring rod is improved, the supporting force of the anchoring rod around the circumference of the stent main body is improved, circumferential displacement is not easy to occur after the replacement valve stent is anchored, and compared with the structure of a single anchoring rod, the replacement valve stent is more stable in anchoring; in addition, because the anchoring rod is in a closed loop structure, compared with a single anchoring rod, the anchoring rod provided by the invention is easier to span the chordae tendineae, so that the chordae tendineae are prevented from being pulled, and unnecessary injury is caused to a patient.

4. The outer contour of the bending part of the middle rod section of the anchoring rod is in a smooth arc shape, so that the free end of the anchoring rod is in a smooth structure, and complications caused by stabbing autologous valve leaflets or myocardial tissues in the anchoring process of the anchoring structure can be effectively prevented.

5. At least half of the middle rod segments in the anchoring rods are bent close to or far away from the main body of the stent along the radial direction, and the differential arrangement of the anchoring rods enables the replacement valve stent to be respectively suitable for the anterior tip and the posterior tip of the mitral valve, so that the transcatheter replacement valve stent is more suitable for the physiological characteristics of the mitral valve while ensuring that myocardial tissues or autologous valve leaflets are not punctured.

6. Compared with the technical scheme of simply depending on the anchoring structure to provide radial supporting force for anchoring, the self-body valve leaflet clamping device can clamp the self-body valve leaflet through the matching of the anchoring structure and the skirt support structure, is stable in clamping, can ensure that the artificial valve does not shift, and avoids the perivalvular leakage or other complications. Especially, after the catheter replacement valve stent is released, the skirt support structure is positioned on the atrium side of the autologous valve leaflets, the anchoring structure is positioned on the ventricle side, the free ends of the anchoring elements extend into the grid openings of the skirt support structure, the roots of the autologous valve leaflets can be clamped, the clamping effect is better, and the catheter replacement valve stent is more stable after being released.

7. The skirt support structure expands towards the outer side of the stent main body, so that the clamping area of the skirt support structure and the anchoring structure to the autologous valve leaflets can be enlarged, and the anchoring of the artificial valve is more stable.

8. Connect additional strengthening between two adjacent anchor poles, additional strengthening can further improve anchor pole's intensity and stability, and the effectual skew that prevents the anchor pole avoids shifting through the pipe replacement valve and influences the clamping stability with the autologous valve ring, avoids taking place the valve perivalvular leak.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 shows a schematic view of one configuration of a transcatheter replacement valve stent provided in example 1 of the present invention;

FIG. 2 shows a front view of FIG. 1;

FIG. 3 shows a top view of FIG. 1;

FIG. 4 shows a schematic structural view of the stent body of FIG. 1;

FIG. 5 shows a front view of FIG. 4;

FIG. 6 shows a schematic structural view of the anchoring structure of FIG. 1;

FIG. 7 shows a front view of FIG. 6;

FIG. 8 shows a top view of FIG. 6;

fig. 9 is a schematic structural view showing the clamping of native valve leaflets after the release of the transcatheter replacement valve stent provided by the embodiment 1 of the invention;

FIG. 10 shows a schematic structural view of a transcatheter replacement valve stent provided in accordance with example 2 of the present invention;

FIG. 11 shows a schematic structural view of the anchoring structure of FIG. 10;

FIG. 12 shows a front view of FIG. 11;

FIG. 13 shows a top view of FIG. 11;

FIG. 14 shows a schematic view of a transcatheter replacement valve stent provided in accordance with example 3 of the present invention;

FIG. 15 shows a schematic structural view of the anchoring structure of FIG. 14;

FIG. 16 shows a top view of FIG. 15;

FIG. 17 shows a schematic structural view of a transcatheter replacement valve stent provided in accordance with example 4 of the present invention;

FIG. 18 shows a schematic structural view of the anchoring structure of FIG. 17;

FIG. 19 shows a top view of FIG. 18;

FIG. 20 is a schematic view of one embodiment of a transcatheter replacement valve stent provided in accordance with example 5 of the present invention;

FIG. 21 shows a schematic structural view of the anchoring structure of FIG. 20;

FIG. 22 shows a top view of FIG. 21;

FIG. 23 shows a schematic of one configuration of a sealing skirt in a transcatheter replacement valve provided in accordance with an embodiment of the present invention;

FIG. 24 shows another structural schematic of a sealing skirt in a transcatheter replacement valve provided in accordance with an embodiment of the invention;

fig. 25 is a schematic structural view showing a state in which the sealing skirt of fig. 22 is sewn to the holder main body;

FIG. 26 illustrates a bottom view of one configuration of a transcatheter replacement valve provided in accordance with example 6 of the present disclosure;

fig. 27 shows a schematic view of a transcatheter replacement valve provided by an embodiment of the present invention during delivery.

Description of the reference numerals:

1. a stent main body; 11. the valve leaf is sewed with the ear; 2. an anchoring structure; 21. an anchor; 211. an anchor rod; 2111. a first pole segment; 2111A, a first bending portion; 2111B, a second bending portion; 2112. a second pole segment; 2113. an intermediate pole segment; 3. a skirt support structure; 31. a first skirt strut section; 32. a second skirt strut section; 33. a grid port; 4. a reinforcing structure; 41. a reinforcing bar; 5. a transport connection structure; 51. a connecting rod; 52. a hanging part; 6. sealing the skirt cloth; 61. a triangular extension section; 7. a prosthetic valve; 8. autologous valve leaflets; 81. rear tip; 82. a front tip; 9. the left atrium; 10. a left ventricle; 20. myocardial tissue; 30. the atrial septum; 40. and (4) bending the sheath tube.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

For convenience of describing the technical scheme of the present invention, the following detailed description is provided in conjunction with the accompanying drawings and specific embodiments, but the embodiments should not be construed as limiting the present invention.

Example 1

A transcatheter replacement valve stent is made of nickel-titanium alloy materials with shape memory function, can be radially compressed, is delivered through a catheter, and is released after reaching a position, so that the stent can realize radial self-expansion and can be expanded into a prefabricated shape. Referring to fig. 1-8, a transcatheter replacement valve stent includes a stent body 1 and an anchoring arrangement 2. Wherein, the stent body 1 is a cylindrical frame structure which can be radially compressed and expanded, and reference can be made to fig. 4 and 5; the stent body 1 has a crimped state and a deployed state; the anchoring structures 2 are arranged around the periphery of the stent body 1; when the stent main body 1 is in a press-holding state, at least part of the anchoring structure 2 is overlapped with the stent main body 1 in the radial direction, so that the transcatheter replacement valve stent forms a double-layer frame structure when being pressed and held; in the deployed state of the stent body 1, the anchoring structures 2 are expanded toward the outside of the stent body 1 to anchor the stent body 1, that is, after the transcatheter replacement valve stent is delivered to a target site, the stent body 1 is anchored by the anchoring structures 2 after being deployed.

By utilizing the technical scheme of the invention, because the stent main body 1 in a pressing and holding state and the anchoring structure 2 are at least partially overlapped with the stent main body 1 in the radial direction, compared with the existing replacement valve stent, the length of the pressed and held replacement valve stent can be greatly shortened, so that the length of the bending sheath 40 occupied by the replacement valve stent in a conveying system is short, the replacement valve stent can avoid a bending part with a larger angle in a releasing process in a narrow space, the bending sheath 40 is easier to bend, and the requirements on the mechanical strength and the performance of the bending sheath 40 of the conveying system are reduced.

The transcatheter replacement valve stent provided by the invention is suitable for aortic valve or mitral valve replacement. The technical solution of the present invention is described here by taking a mitral valve replacement valve stent as an example.

Referring to fig. 25, the delivery system includes a bending-adjusting sheath 40, the bending-adjusting sheath 40 is inserted into the bending-adjusting sheath 40 after the artificial valve 7 carried by the ductal replacement valve stent is crimped, the bending-adjusting sheath 40 passes through the atrial septum 30 from the right atrium and enters the left atrium 9, at this time, bending of approximately 90 ° is required, the head end of the bending-adjusting sheath 40 is in a transverse state when passing through the atrial septum 30 and continues to advance, and entering the left ventricle 10 is required to be bent from a transverse direction to a vertical direction, that is, the bending-adjusting sheath 40 has a bending-adjusting head end approximately 90 ° to the main body thereof, which is also the region with the largest bending-adjusting angle in the whole replacement operation. However, in the prior art, the axial length of the crimped replacement valve stent is greater than the axial length of the crimped replacement valve stent in the expanded state, the left atrium 9 has a narrow space and a large bending difficulty, and the crimped replacement valve stent is loaded in the bending sheath 40, so that the bending difficulty is greater, and the requirements on the mechanical strength and the performance of the bending sheath 40 are higher.

Further, referring to fig. 1 to 8, the stent body 1 has a first end and a second end which are oppositely arranged, and the first end of the stent body 1 is a lower end and is also an outflow end when viewed in the orientation of fig. 2; the second end of the stent body 1 is the upper end and is also the inflow end.

Further, referring to fig. 6 and 7, the anchoring structure 2 includes a plurality of anchoring elements 21 spaced around the outer circumference of the stent body 1, the anchoring elements 21 having fixed ends and free ends, the fixed ends being connected to the stent body 1, and the free ends of the anchoring structure 2 expanding radially outward of the stent body 1 in the expanded state of the stent body 1 and adapted to provide radial supporting force to the stent body 1 to anchor the stent body 1. In a preferred embodiment, the fixed end is connected to the first end of the stent body 1, and the free end extends toward the second end of the stent body 1, so that when the stent body 1 is in a crimped state, at least one of the stent body 1 and the anchoring structure 2 is completely overlapped with the other in the radial direction. This maximizes the length of overlap between the anchoring structure 2 and the stent body 1 in the radial direction, and minimizes the length of the crimped replacement valve stent. In this embodiment, since the second end of the stent main body 1 is further connected with the skirt structure 3, the total axial length of the skirt structure 3 and the stent main body 1 is greater than the axial length of the anchor 21 in the crimped state, that is, the stent main body 1 completely overlaps with the anchor 21 in the radial direction in the crimped state.

A plurality of anchor 21 that the periphery interval of support main part 1 set up can provide the radial holding power around its a week for support main part 1, guarantees support main part 1 anchor stable. In a preferred embodiment, the plurality of anchoring elements 21 are uniformly spaced around the circumference of the stent body 1, so that the stent body 1 is uniformly supported in the circumferential direction, and the stent body 1 is ensured not to be displaced in the radial direction.

Further, anchor 21 includes an anchor rod 211, and referring to fig. 6 and 7, anchor rod 211 includes a first rod segment 2111, a second rod segment 2112, and an intermediate rod segment 2113 connecting first rod segment 2111 and second rod segment 2112; the intermediate post segment 2113 is a bent post, which may resemble the shape of the letter "n" or "m". The first ends of the first and

second sections

2111, 2112 are connected to the first end of the stent body 1 to form the fixed end, the second ends of the first and

second sections

2111, 2112 extend axially toward the second end of the stent body 1 and are connected by the intermediate section 2113 to form a closed loop, and the intermediate section 2113 forms the free end. The anchoring rod 211 can be seen as a rod, which is bent from the middle part, both ends of which are connected to the first end of the holder body 1 to form said fixed end, and the bent middle part extends towards the second end of the holder body 1 to form said free end.

The first rod section 2111 and the second rod section 2112 of the anchoring rod 211 are connected into a closed-loop structure through the middle rod section 2113, so that the strength of the anchoring rod 211 is improved, meanwhile, the supporting force of the anchoring rod 211 around the circumferential direction of the stent main body 1 is improved, circumferential displacement is not easy to occur after the replacement valve stent is anchored, and compared with a structure of a single anchoring rod 211, one end of which is connected with the stent main body 1, and the other end of which is a free end, the replacement valve stent is more stable in anchoring; in addition, since the anchor rod 211 is a closed loop structure, the anchor rod 211 of the present invention is easier to cross the chordae tendineae than a single anchor rod 211, avoiding pulling the chordae tendineae and causing unnecessary injury to the patient.

Further, the outer contour of the bent portion of the middle bar section 2113 is a smooth arc. The outer contour here means an outer contour on the side of the bent projection.

The middle rod section 2113 is used as the free end of the anchoring rod 211 to directly contact with the autologous valve leaflet 8 or the myocardial tissue 20 of the patient, and the outer contour of the bending part of the middle rod section 2113 of the anchoring rod 211 is set to be a smooth arc shape, so that the anchoring structure 2 can be effectively prevented from stabbing the autologous valve leaflet 8 or the myocardial tissue 20 in the anchoring process, and complications are caused.

Further, of the plurality of anchor rods 211, there are at least half as many intermediate rod segments 2113 that are bent radially toward or away from the stent body 1 to accommodate the posterior tip 81 of the mitral valve.

At least half of the number of intermediate stem segments 2113 of the plurality of anchoring stems 211 are bent radially closer to or further from the stent body 1, and this differential arrangement of the anchoring stems 211 enables the replacement valve stent to adapt to the anterior cusp 82 and the posterior cusp 81 of the mitral valve, respectively, so that the transcatheter replacement valve stent better adapts to the physiological properties of the mitral valve while ensuring that the myocardial tissue 20 or the native valve leaflets 8 are not punctured. Specifically, the mitral valve has an anterior tip 82 and a posterior tip 81, and referring to fig. 9, the anterior tip 82 is proximal to the interatrial septum 30, the posterior tip 81 is distal to the interatrial septum 30, and the posterior tip 81 is attached to the myocardial tissue 20. Therefore, the anchoring bar 211 near the anterior tip 82 portion does not have to take into account the problem of puncturing the myocardial tissue 20, while the anchoring bar 211 near the posterior tip 81 portion takes into account the problem of puncturing the myocardial tissue 20 and puncturing the native leaflets 8. To accommodate this physiological characteristic, the present embodiment, as a preferred embodiment, provides a differential arrangement of anchor rods 211. Referring to fig. 1 to 8, in the present embodiment, 6 anchor rods 211 are provided, and are uniformly spaced around the stent body 1. These 6 anchor rods 211 are equally divided into two clamping groups, the first clamping group comprising 3 anchor rods 211 with the intermediate rod segments 2113 of the 3 anchor rods 211 being free from bending in the radial direction of the stent body 1, accommodating the anterior tip 82, the second clamping group comprising the other 3 anchor rods 211 with the intermediate rod segments 2113 of the 3 anchor rods 211 being bent in the radial direction of the stent body 1 close to the stent body 1, accommodating the posterior tip 81 of the mitral valve. Because the middle rod section 2113 is a bent rod, and the outer contour of the bent part is a smooth circular arc, no matter the bent part is positioned at the front tip 82 and the rear tip 81, the puncture can be avoided. The anchoring rod 211 of the second clamping group at the rear tip 81 is used for clamping the root of the autologous valve leaflet 8 because the middle rod section 2113 can be subsequently matched with the skirt support structure 3, the middle rod section 2113 is bent along the radial direction of the support main body 1, not only the myocardial tissue 20 can be prevented from being punctured, but also the root of the autologous valve leaflet 8 can be prevented from being punctured, in addition, after the bending, the anchoring rod 211 is matched with the skirt support structure 3, the area for clamping the autologous valve leaflet 8 is increased, and the anchoring stability of the support main body 1 can be further improved.

Specifically, referring to fig. 7 or 12, the first stem segment 2111 includes a first bending portion 2111A and a second bending portion 2111B sequentially arranged from the first end to the second end, the first bending portion 2111A is convexly bent toward the stent body 1 in the radial direction, and the second bending portion 2111B is convexly bent away from the stent body 1 in the radial direction. When the stent main body 1 is unfolded, the autologous valve leaflet 8 can be clamped between the anchoring rod 211 and the stent main body 1, and the first bending part 2111A and the second bending part 2111B are bent towards opposite directions, so that the anchoring rod 211 has elastic force towards one side of the stent main body 1, namely the clamping force between the anchoring rod 211 and the stent main body 1 is enhanced, the autologous valve leaflet 8 can be further clamped, and the stent main body 1 can be anchored stably. In this embodiment, the first stem segment 2111 and the second stem segment 2112 are identical in structure.

Further, through pipe replacement valve support still include the skirt strut structure 3, and skirt strut structure 3 sets up around the periphery of support main part 1, and support main part 1 is in the state of expanding, and skirt strut structure 3 expands towards the outside of support main part 1, and with the anchoring structure 2 cooperation of the same outside expansion, constitutes fixture for centre gripping autologous leaflet 8.

Compared with the technical scheme of simply depending on the anchoring structure 2 to provide radial supporting force to anchor the stent main body 1, the self-body valve leaflet bracket can clamp the self-body valve leaflet 8 through the matching of the anchoring structure 2 and the skirt support structure 3, is stable in clamping, ensures that the stent main body 1 is not easy to displace along the axial direction and the circumferential direction of the stent main body 1, and avoids the perivalvular leakage or other complications. In addition, through pipe replacement valve release back, because skirt structure 3 is located the atrium side of autologous valve leaf 8, anchoring structure 2 is located the ventricle side, can carry out the centre gripping to the root of autologous valve leaf 8, and the centre gripping effect is better, and especially when the heart contracts, anchoring structure 2 and skirt structure 3 centre gripping are tighter for through pipe replacement valve release back anchor is more stable.

Specifically, the apron structure 3 is an annular frame structure, the inner ring of the apron structure 3 is connected with the second end of the support main body 1, and the outer ring of the apron structure 3 extends towards the outer side of the support main body 1.

The outer ring of the skirt support structure 3 is larger in size than the diameter of the stent body 1. After release of the transcatheter replacement valve stent, the skirt structure 3 is located in the left atrium 9, i.e. on the upper side of the native valve leaflet 8 of the patient. The outer side of the skirt support structure 3 towards the support main body 1 is expanded, so that the clamping area of the skirt support structure 3 and the anchoring structure 2 to the autologous valve leaflet 8 can be enlarged, and the support main body 1 is anchored more stably.

Further, referring to fig. 4, the skirt support structure 3 includes a first skirt support section 31 connected to the support main body 1 and a second skirt support section 32 connected to the first skirt support section 31, the first skirt support section 31 is radially away from the support main body 1 along the support main body 1 and is arranged to be bent, and the second skirt support section 32 is radially close to the support main body 1 and is arranged to be bent along the support main body 1.

In a preferred embodiment, the first skirt section 31 is smoothly connected to the stent body 1, and the first skirt section 31 is smoothly connected to the second skirt section 32. The skirt support structure 3 may be visualized as a dish-type net support as shown in fig. 1, 4 or 5. The skirt structure 3 provides support for the stitching of the flexible sealing skirt 6. The sealing skirt 6 will be described later. Referring to fig. 4, the second skirting segment 32 is bent to fit the myocardial tissue 20 or the atrial septum 30, thereby improving the sealing effect.

Further, the skirt structure 3 has a grid opening 33, and the free end of the anchor 21 extends into the grid opening 33, i.e. the intermediate bar section 2113 of the anchor bar 211 extends into the grid opening 33. Specifically, a grid opening 33 is formed between the first skirt section 31 and the second skirt section 32, or between the second skirt section 32 and the stent main body 1. The skirt structure 3 is provided with a plurality of mesh openings 33 around the circumference of the stent body 1, and after the replacement valve stent is released, each mesh opening 33 corresponds to the middle rod section 2113 of each anchoring rod 211 one by one. As described above, referring to fig. 9, after the transcatheter replacement valve stent is released, the skirt structure 3 is positioned in the left atrium 9, i.e., at the upper portion of the native valve leaflet 8, the anchoring rod 211 is positioned in the left ventricle 10, i.e., at the lower portion of the native valve leaflet 8, and the skirt structure 3 and the anchoring rod 211 clamp the native valve leaflet 8 therebetween. When the ventricle contracts, the anchoring rod 211 is matched with the skirt support structure 3 to clamp the autologous valve leaflet 8, so that the valve is prevented from being displaced by the catheter replacement, and the paravalvular leakage is prevented.

Skirt strut structure 3's net mouth 33 has at least two skirt struts to play clamping action to autologous leaflet 8, compare in anchoring rod 211 and skirt strut structure 3's single skirt strut correspond the scheme of cooperation centre gripping autologous leaflet 8, anchoring rod 211's second end extends to skirt strut structure 3's net mouth 33 department, there are two skirt struts and anchoring rod 211 cooperation centre gripping autologous leaflet 8 at least, the clamping area is big, the centre gripping is more stable, guarantee through the difficult circumference and the axial aversion of taking place along support main part 1 of pipe replacement valve.

The skirt support structure 3 is a ring-shaped frame structure, and the anchor rods 211 are arranged in plurality at intervals around the stent body 1, so that a plurality of clamping points are formed around the stent body 1 between the skirt support structure 3 and the anchor rods 211. In this embodiment, anchor rod 211 is evenly spaced around support main body 1a week and is set up, like this for anterior cusp 82 and posterior cusp 81 of mitral valve can both receive even clamping-force, guarantee that the centre gripping is stable.

In addition, when the middle rod section 2113 of the anchor rod 211 is bent towards one side along the radial direction of the stent main body 1 and is matched with the skirt strut structure 3, because the anchor rod 211 has elastic deformation capacity, the bent part can provide clamping force towards the inner side of the stent main body 1, and the first skirt strut section 31 is bent towards the outer side of the stent main body 1, the two are oppositely arranged and mutually cater, so that the clamping effect of the anchor rod 211 and the skirt strut structure 3 is enhanced, and the clamping is more stable.

Further, a reinforcing structure 4 is connected between two adjacent anchors 21.

The reinforcing structure 4 is connected between two adjacent anchoring rods 211, the reinforcing structure 4 can further improve the strength and stability of the anchoring rods 211, effectively prevent the anchoring rods 211 from shifting, avoid the influence on the clamping stability with the autologous valve annulus caused by the displacement of the valve stent replaced by a catheter, and ensure the uniform distribution and the transverse stability of each anchoring rod 211, and the horizontal stability can be also said in the view of the position of fig. 2, thereby avoiding the valve leakage caused by the circumferential displacement of the stent main body 1.

Further, the reinforcing structure 4 includes a reinforcing rod 41, the reinforcing rod 41 is one or a combination of V-shaped, U-shaped and W-shaped, and two ends of the reinforcing rod 41 are respectively connected to two adjacent anchoring members 21. Specifically, in this embodiment, the stiffener 41 is V-shaped, with one end of the stiffener 41 being connected to the first segment 2111 of one anchor bar 211 and the other end of the stiffener 41 being connected to the second segment 2112 of the other anchor bar 211. The reinforcing bar 41 is attached to the stent body 1 by sewing with a suture, which is omitted from the drawings. The V-shape, U-shape, and W-shape mean that the shape of the stiffener 41 is substantially the same, and the stiffener 41 and the stent body 1 are connected by sewing, so the installation direction of the stiffener 41 is not limited, and in the example of the V-shaped stiffener 41, the tip of the V-shaped stiffener 41 faces the second end of the stent body 1, and in the present embodiment, the tip of the V-shaped stiffener 41 faces downward when viewed from the orientation of fig. 7. Of course, in some other embodiments, the tip of the V-shaped stiffener 41 may be disposed upward. Further, the position of connection of the reinforcing bar 41 is not limited to the first end of the stent body 1, and may be located in the middle of the stent body 1, and in this case, in order not to affect the expansion of the anchor rod 211, the reinforcing bar 41 may not be connected to the stent body 1, and the reinforcing bar 41 integrally connects the plurality of anchor elements 21 to form a closed frame, thereby further improving the circumferential stability of the anchor structure 2.

Further, the second end of the support main body 1 is provided with a conveying connecting structure 5, the conveying connecting structure 5 comprises a plurality of connecting rods 51 which are arranged around the support main body 1 at intervals, one ends of the connecting rods 51 are connected with the second end of the support main body 1, the other ends of the connecting rods 51 extend along the axial direction of the support main body 1 far away from the second end of the support main body 1, hanging parts 52 are arranged at the end parts of the connecting rods, and the hanging parts 52 are suitable for being connected with a conveying system. The hanging part 52 protrudes from the connecting rod 5171, which is beneficial to providing an acting point for the connection of the stent body 1 and the delivery system, and meanwhile, the skirt support structure 3 can be prevented from generating impact force in the releasing process, which causes the displacement of the anchor 21 and even causes heart damage. In this embodiment, the connecting rods 51 are provided with six connecting rods, and are uniformly spaced around the bracket body 1, and the hanging part 52 is a cross rod perpendicular to the connecting rods 51. Of course, the hanging part 52 may be a ring or other structure protruding from the connecting rod 51.

Further, the stent body 1 is provided with a plurality of leaflet suture ears 11 around the circumference of the stent body 1. The leaflet sewing ears 11 provide sewing holes in the stent body 1, providing support for sewing of the prosthetic valve 7 of a bio-or non-bio-flexible material.

Example 2

This embodiment provides a modified embodiment, with reference to fig. 10-13, differing from embodiment 1 in that the middle segments 2113 of the three anchoring rods 211 of the second clamping group are bent away from the stent body 1.

Example 3

This embodiment provides a modified embodiment, and referring to fig. 14 to 16, the difference from embodiment 2 is that 12 anchor rods 211 are provided around the

stent body

1, and 6 anchor rods are provided for each of the first and second clamp groups.

Example 4

This example provides a modified embodiment, and with reference to fig. 17 to 19, differs from example 2 in that 6 anchor rods 211 are not distinguished to accommodate either the front tip 82 or the rear tip 81, and the intermediate rod segments 2113 of the 6 anchor rods 211 are each bent away from the stent body 1.

Example 5

This embodiment provides a modified embodiment, and referring to fig. 20 to 22, the difference from embodiment 4 is that 12 anchor rods 211 are provided at regular intervals around the outer circumference of the stent body 1.

Of course, the anchoring structure 2 is not limited to the structures of the above 5 embodiments.

Example 6

The present example provides a transcatheter replacement valve device comprising the transcatheter replacement valve stent of any one of examples 1-5.

Further, in this embodiment, a sealing skirt cloth 6 is connected to the skirt structure 3, and the structure of the sealing skirt cloth 6 is shown in fig. 23. In this embodiment, the skirt fabric 6 is a PET mesh fabric. Sealed skirt cloth 6 locates the inboard of support main part 1 around the 1 round laminating of support main part, and the first end and the skirt strut structure 3 of sealed skirt cloth 6 are connected, and the second end of sealed skirt cloth 6 extends towards the first end of support main part 1.

Further, as a modified embodiment, as shown in fig. 24, the sealing skirt cloth 6 may further be provided with a triangular extension section 61 at the second end of the sealing skirt cloth 6, to give a higher sealing effect, and the position where the sealing skirt cloth 6 is sewn on the stent body 1 is shown in fig. 25, in this embodiment, the stent body 1 is a rhombic grid structure, and the triangular extension section 61 of the sealing skirt cloth 6 is adapted to a triangular window exposed by the rhombic grid of the stent body 1.

Furthermore, the transcatheter replacement valve stent also comprises a valve leaflet suture ear 11, and the second end part of the sealing skirt cloth 6 or the valve leaflet suture ear 11 is completely covered, so that the sealing effect can be effectively enhanced, and the perivalvular leakage can be prevented.

Further, the inner side of the stent main body 1 is positioned at the leaflet sewing ear 11 and is connected with a prosthetic valve 7 in a sewing way; the prosthetic valve 7 is provided with two pieces, suitable for replacing the mitral valve of the patient; alternatively, the prosthetic valve 7 is provided with three pieces, see fig. 26, adapted to replace the aortic valve of the patient; alternatively, the prosthetic valve 7 is provided with four pieces, adapted to the heart valve of a particular patient.

A percutaneous catheter is a catheter that is inserted into the skin with a needle. All catheters are hollow catheters allowing fluid to enter the body or excess fluid to be removed from the body through the catheter to a suitable disposal container.

A method of using a transcatheter replacement valve device for a mitral valve, comprising the steps of:

step S1: puncturing a femoral vein on one side of a patient, sending a guide wire and a puncturing sheath into the right atrium, puncturing the interatrial septum 30, and entering the left ventricle 10 through the mitral valve;

step S2: loading the transcatheter replacement valve device into a corresponding delivery system, and delivering the delivery system along a guide wire track into the left ventricle 10;

and step S3: adjusting the direction of the conveying system through the marks on the conveying system, enabling the second clamping group of the anchoring rod 211 to turn to the back leaf surface of the mitral valve, releasing the anchoring rod 211, adjusting the position to enable the anchoring rod 211 of the second clamping group to push to the root part of the back leaf, enabling the anchoring rod 211 of the first clamping group to push to the root part of the front leaf of the mitral valve, continuously releasing the leaflet suture ear 11 and the skirt support structure 3 at the atrium end, enabling the skirt support structure 3 to be supported at the bottom of the atrium, and finally releasing the conveying connecting structure 5;

and step S4: the delivery system of the interventional mitral valve is withdrawn to the right atrium and sent to the atrial septum 30 occluder to occlude the atrial septum 30, and the operation is completed.

In the above steps, the sheath tube is withdrawn in one direction to complete the three steps of positioning, fixing and releasing, so that the radial size of the conveying system is effectively reduced, and the compression and damage of the head end of the conveying system to the compartment space are reduced.

The operation process comprises the following steps: the puncture femoral vein enters the way through the interatrial septum 30, the puncture ventricular septum establishes a guide wire track from the left ventricle 10 to the right ventricle, the guide wire is sent into the interventional transcatheter replacement valve device, the anchoring rod 211 is released, the sheath is withdrawn, and the artificial valve 7 is released. The atrial septum 30 is sealed and the operation is over.

According to the above description, the present patent application has the following advantages:

1. the length of the replacement valve stent after being crimped can be shortened, and the length of the occupied bending sheath tube 40 is short, so that the replacement valve stent can avoid a bending part with a larger angle in the release process in a narrow space, and the bending sheath tube 40 is easier to bend;

2. the anchoring rod 211 is connected with the stent main body 1 to form a closed loop structure, so that the strength of the anchoring rod 211 is improved, and the circumferential supporting force is provided for the stent main body 1, so that the replacement valve stent is not easy to displace circumferentially after being anchored, and the anchoring is more stable;

3. the free end of the anchoring rod 211 is of a smooth structure, which can effectively prevent the anchoring structure 2 from stabbing the autologous valve leaflet 8 or the myocardial tissue 20 to cause complications in the anchoring process;

4. the anchoring rod 211 is arranged to adapt to the difference between the front tip 82 and the back tip 81, so as to ensure that the myocardial tissue 20 or the autologous valve leaflet 8 is not punctured;

5. the anchoring structure 2 is matched with the skirt support structure 3 to clamp the autologous valve leaflets 8, and can clamp the roots of the autologous valve leaflets 8, so that the clamping is stable, the artificial valve 7 can be prevented from moving, and the perivalvular leakage or other complications are avoided;

6. reinforcing structure 4 can further improve the intensity and the stability of anchor pole 211, and the effectual skew that prevents anchor pole 211 avoids shifting through the pipe replacement valve and influences the clamping stability with the autologous valve ring, avoids taking place the valve perivalvular leakage.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. A transcatheter replacement valve stent, comprising:

the bracket main body (1) is a cylindrical frame structure which can be radially compressed and expanded and has a pressing and holding state and an expanded state;

an anchoring structure (2), the anchoring structure (2) being arranged around the periphery of the stent body (1); in the crimped state of the stent main body (1), the anchoring structure (2) at least partially overlaps the stent main body (1) in the radial direction, so that the transcatheter replacement valve stent forms a double-layer frame structure when crimped; in the deployed state of the stent body (1), the anchoring structure (2) expands toward the outside of the stent body (1) to anchor the stent body (1).

2. The transcatheter replacement valve stent according to claim 1, wherein the anchoring structure (2) comprises a plurality of anchors (21) spaced around the circumference of the stent body (1), the anchors (21) having fixed ends and free ends, the fixed ends being connected to the stent body (1); in the expanded state of the stent main body (1), the free end expands outwards along the radial direction of the stent main body (1) and is suitable for providing radial anchoring force for the stent main body (1).

3. The transcatheter replacement valve stent of claim 2, wherein the anchor (21) comprises an anchor rod (211), the anchor rod (211) comprising a first rod segment (2111), a second rod segment (2112), and an intermediate rod segment (2113) connecting the first rod segment (2111) and the second rod segment (2112); the middle rod section (2113) is a bending rod, the first ends of the first rod section (2111) and the second rod section (2112) are connected with the bracket main body (1) to form the fixed end, the second ends of the first rod section (2111) and the second rod section (2112) extend along the axial direction of the bracket main body (1) and are connected into a closed loop structure through the middle rod section (2113), and the middle rod section (2113) forms the free end.

4. The transcatheter replacement valve stent according to claim 3, wherein the outer profile of the bend of the middle rod segment (2113) is a rounded arc.

5. The transcatheter replacement valve stent according to claim 3, wherein of the plurality of anchoring rods (211) at least half of the number of intermediate rod segments (2113) are bent radially closer to or further from the stent body (1) to prevent puncturing of myocardial tissue (20).

6. The transcatheter replacement valve stent according to claim 3, wherein the first stem segment (2111) includes a first bending portion (2111A) and a second bending portion (2111B) arranged in sequence from the first end to the second end, the first bending portion (2111A) being convexly curved radially closer to the stent body (1), and the second bending portion (2111B) being convexly curved radially away from the stent body (1); the second pole segment (2112) is structurally identical to the first pole segment (2111).

7. The transcatheter replacement valve stent according to any one of claims 2-6, wherein the fixed end is connected to a first end of the stent body (1) and the free end extends towards a second end of the stent body (1), such that when the stent body (1) is in a crimped state, there is full overlap of at least one of the stent body (1) and the anchoring structure (2) with the other in a radial direction.

8. The transcatheter replacement valve stent according to any one of claims 2-7, further comprising a skirt support structure (3), the skirt support structure (3) being disposed around a periphery of the stent body (1), the stent body (1) being in the deployed state, the anchoring structure (2) cooperating with the skirt support structure (3) for clamping a native valve leaflet (8).

9. The transcatheter replacement valve stent according to claim 8, wherein the skirt structure (3) is an annular frame structure, an inner ring of the skirt structure (3) being connected with the second end of the stent body (1), an outer ring of the skirt structure (3) expanding towards the outside of the stent body (1).

10. The transcatheter replacement valve stent according to claim 9, wherein the skirt structure (3) comprises a first skirt section (31) connected to the stent body (1) and a second skirt section (32) connected to the first skirt section (31), the first skirt section (31) being curved away from the stent body (1) in a radial direction of the stent body (1), the second skirt section (32) being curved closer to the stent body (1) in the radial direction of the stent body (1).

11. The transcatheter replacement valve stent according to claim 10, wherein there is a grid opening (33) between the first skirt section (31) and the stent body (1) or between the first skirt section (31) and the second skirt section (32), the free end extending into the grid opening (33).

12. The transcatheter replacement valve stent according to any one of claims 2-11, wherein a reinforcing structure (4) is connected between two adjacent anchors (21).

13. The transcatheter replacement valve stent according to claim 12, wherein the reinforcing structure (4) comprises a reinforcing rod (41), the reinforcing rod (41) being a combination of one or more of V-shaped, U-shaped, W-shaped, the ends of the reinforcing rod (41) being connected to two adjacent anchors (21), respectively.

14. The transcatheter replacement valve stent according to any one of claims 1-13, wherein the second end of the stent body (1) is provided with a delivery connection structure (5), the delivery connection structure (5) comprises a plurality of connecting rods (51) arranged at intervals around the stent body (1), one end of each connecting rod (51) is connected with the second end of the stent body (1), the other end of each connecting rod (51) extends away from the second end of the stent body (1) along the axial direction of the stent body (1), and a hanging part (52) is arranged at the end part, and the hanging part (52) is suitable for being connected with a delivery system.

15. The transcatheter replacement valve stent according to any one of claims 1-14, wherein the stent body (1) is provided with a plurality of leaflet suture ears (11) around the circumference of the stent body (1).

16. A transcatheter replacement valve device comprising the transcatheter replacement valve stent of any one of claims 1-15.

17. The transcatheter replacement valve device according to claim 16, wherein the stent body (1) has a skirt structure (3), a sealing skirt (6) being connected to the skirt structure (3), the sealing skirt (6) being snugly provided inside the stent body (1) around a circle of the stent body (1), a first end of the sealing skirt (6) being connected to the skirt structure (3), and a second end of the sealing skirt (6) extending towards the first end of the stent body (1).

18. The transcatheter replacement valve device according to claim 17, wherein the transcatheter replacement valve stent further comprises a leaflet suture ear (11), the second end of the sealing skirt (6) partially or completely covering the leaflet suture ear (11).

19. The transcatheter replacement valve device according to any one of claims 16-18, wherein the transcatheter replacement valve stent further comprises a leaflet suture ear (11), wherein a prosthetic valve (7) is sutured to the inside of the stent body (1) at the leaflet suture ear (11); the artificial valve (7) is provided with two pieces, which are suitable for replacing the mitral valve of a patient; or, the artificial valve (7) is provided with three pieces, suitable for replacing the aortic valve of the patient; or the artificial valve (7) is provided with four pieces and is suitable for the heart valve of a special patient.