CN115227451A - Transcatheter valve replacement device and stent thereof - Google Patents

Abstract

The invention provides a transcatheter valve replacement device and a stent thereof, and relates to the technical field of heart valves. A transcatheter replacement valve stent includes a stent body and a clamping mechanism. Wherein, the bracket main body is a cylindrical frame structure which can be radially compressed and expanded; fixture sets up around support main part periphery, and fixture includes skirt strut structure and the anchoring structure of being connected with the support main part respectively, and skirt strut structure and anchoring structure cooperate, are suitable for centre gripping autologous leaflet. The invention can solve the problem of artificial valve displacement in the prior art, clamps the autologous valve leaflet stably by matching the anchoring structure with the skirt support structure, can ensure that the artificial valve is not displaced, and avoids valve leakage or other complications.

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). Most of the existing transcatheter mitral valve replacement systems rely on radial supporting force to anchor or clamp the artificial valve, and the radial supporting force anchoring easily causes the artificial valve to shift due to insufficient anchoring force, thereby causing paravalvular leakage or other complications. Accordingly, there is a need to provide a transcatheter replacement valve that is capable of anchoring stability.

Disclosure of Invention

Therefore, the technical problem to be solved by the present invention is to overcome the defect of the artificial valve displacement in the prior art, and to provide 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 a clamping mechanism. 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; fixture sets up around the periphery of support main part, and fixture includes skirt strut structure and the anchoring structure who is connected with the support main part respectively, is in the state of expanding at the support main part, and skirt strut structure and anchoring structure cooperate, are suitable for the centre gripping autologous valve leaflet.

Optionally, the skirt support structure is arranged at the first end of the bracket main body; the skirt support structure encircles the stent body for a circle and expands towards the outside of the stent body.

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 outside crooked setting of first skirt strut section, the inside crooked setting of second skirt strut section.

Optionally, the anchoring arrangement includes a plurality of anchors spaced around the periphery of the stent body, the anchors cooperating with the skirt structure for gripping the native valve leaflets.

Optionally, the anchoring element comprises an anchoring rod, a first end of which is connected to the stent body and a second end of which extends towards the skirt structure and cooperates with the skirt structure for gripping the autologous leaflets.

Optionally, the second end of the anchor rod is provided with a protective structure.

Optionally, the protective structure includes an expansion block protruding from the anchor rod, and an outer contour of the expansion block is a smooth curve.

Optionally, the second end of the anchor rod is bent towards one side to form the guard structure.

Optionally, the second end of the anchor rod is bent close to the stent body; or, the second end of the anchor rod is bent away from the stent body.

Optionally, the arc line curved by the second end of the anchoring rod is a major arc to adapt to the posterior tip of the mitral valve; alternatively, the second end of the anchoring rod may be curved in a minor arc to accommodate the anterior cusp of the mitral valve.

Optionally, the plurality of anchoring elements are divided into a first clamping group and a second clamping group, the second ends of the anchoring rods of the first clamping group are bent close to the stent body, and the second ends of the anchoring rods of the second clamping group are bent away from the stent body.

Optionally, a reinforcing structure is connected between two adjacent anchor rods.

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

Optionally, the first end of the anchor rod is connected to the second end of the stent main body, and in the crimped state, the anchor rod does not overlap with the stent main body in the radial direction of the stent main body.

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

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

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

Optionally, be connected with sealed skirt cloth in the skirt strut structure, the inboard of support main part is located around support main part round laminating to sealed skirt cloth, and the first end and the skirt strut structural connection of sealed skirt cloth, the second end of sealed skirt cloth extends towards the second 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, which are suitable for replacing the aortic valve of the patient; in some special medical conditions, the prosthetic valve may also be provided in four pieces.

The invention has the following advantages:

1. compared with the prior technical scheme of anchoring by means of radial supporting force, the anchoring structure provided by the invention can be matched with the skirt support structure to clamp the autologous valve leaflets stably, so that the artificial valve is prevented from shifting, and perivalvular leakage or other complications are avoided. In addition, because the skirt support structure is located the atrium side of autologous leaflet, can the root of centre gripping autologous leaflet, the centre gripping effect is better for it is more stable after the valve release is replaced to the pipe.

2. 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.

3. The second end of anchor pole sets up protective structure, can prevent that the tip of anchor pole from stabbing cardiac muscle tissue or autologous valve leaf, brings unnecessary damage to the patient.

4. The anchoring elements are divided into a first clamping group and a second clamping group, the bending direction of the second end of the anchoring rod of the first clamping group is opposite to that of the second end of the anchoring rod of the second clamping group, in addition, the bending arc of the second end of the anchoring rod of the first clamping group is a major arc, the bending arc of the second end of the anchoring rod of the second clamping group is a minor arc, the first clamping group and the second clamping group are arranged in a differentiated mode and can be respectively adaptive to the anterior cusp and the posterior cusp of the mitral valve, so that the transcatheter replacement valve stent is more adaptive to the physiological characteristics of the mitral valve while guaranteeing that myocardial tissue or autologous valve leaflets are not punctured.

5. Connect additional strengthening between two adjacent anchor poles, additional strengthening can improve the intensity and the stability of anchor pole, and the effectual skew that prevents the anchor pole avoids shifting through the pipe replacement valve and influences the axiality with the autologous valve ring, avoids taking place the valve perivalvular leakage.

6. Under the state of pressing and holding, the anchoring rod can be turned over to extend along the axial of the main body of the stent, so that only a single layer of the valve stent is replaced through the catheter, the conveying size of the valve stent replaced through the catheter can be effectively reduced, and the conveying process is more smooth.

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 embodiments or the prior art descriptions 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 structural view of a transcatheter replacement valve stent provided in accordance with example 1 of the present invention;

FIG. 2 illustrates a front view of a transcatheter replacement valve stent provided in accordance with example 1 of the present invention;

FIG. 3 shows a top view of a transcatheter replacement valve stent provided in accordance with example 1 of the present disclosure;

FIG. 4 shows an axial cut-away view of a transcatheter replacement valve stent provided in accordance with example 1 of the present invention;

FIG. 5 shows a schematic structural view of a transcatheter replacement valve stent with the anchoring structures removed;

FIG. 6 shows a front view of FIG. 5;

fig. 7 shows a schematic structural view of the anchor rods of the first clamping group and the anchor rods of the second clamping group provided in embodiment 1 of the present invention;

fig. 8 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. 9 shows a schematic structural view of a transcatheter replacement valve stent provided in accordance with example 2 of the present invention;

FIG. 10 shows a front view of FIG. 9;

FIG. 11 shows a schematic structural view of a transcatheter replacement valve stent provided in accordance with example 3 of the present invention;

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

FIG. 13 shows a schematic structural view of a transcatheter replacement valve stent provided in accordance with example 4 of the present invention;

FIG. 14 shows a cut-away view in the axial direction of FIG. 13;

FIG. 15 shows a schematic structural view of the anchoring structure of FIG. 13;

FIG. 16 shows a schematic structural view of a transcatheter replacement valve stent provided in accordance with example 5 of the present invention;

FIG. 17 shows a schematic structural view of the anchoring structure of FIG. 16;

FIG. 18 shows a schematic of one configuration of a sealing skirt in a transcatheter replacement valve provided in accordance with an embodiment of the invention;

FIG. 19 shows a schematic view of the anchoring structure in a crimped state and in a deployed state;

FIG. 20 shows another schematic of a sealing skirt in a transcatheter replacement valve provided in accordance with an embodiment of the invention;

fig. 21 is a schematic structural view showing a state in which the sealing skirt is sewn to the holder main body in fig. 20.

Description of the reference numerals:

1. a stent body; 2. a skirt support structure; 21. a first skirt strut section; 22. a second skirt strut section; 3. an anchoring structure; 30. an anchor; 300. an anchor rod; 31. a first clamping group; 32. a second clamping group; 4. A native leaflet; 41. rear tip; 42. a front tip; 5. a protective structure; 51. an extension block; 6. a reinforcing structure; 61. a reinforcing bar; 7. a transport connection structure; 71. a connecting rod; 72. a hanging part; 8. the valve leaf is sewed with the ear; 9. sealing the skirt cloth; 91. a triangular extension section; 10. a prosthetic valve; 11. the left atrium; 12. A left ventricle; 13. myocardial tissue; 14. the atrial septum.

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 simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular 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 and may be, for example, fixedly connected, detachably connected, or integrally connected; 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 according to specific situations by those of ordinary skill in the art.

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 valve replacement 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 expansion into a prefabricated shape. Referring to fig. 1-8, a transcatheter replacement valve stent includes a stent body 1 and a clamping mechanism. Wherein, the stent body 1 is a cylindrical frame structure which can be radially compressed and expanded, and reference can be made to fig. 5 and 6; the stent body 1 has a crimped state and a deployed state, see fig. 19. Fixture sets up around the periphery of support main part 1, and fixture includes skirt strut structure 2 and the anchoring structure 3 of being connected with support main part 1 respectively, and when support main part 1 was in the expanded condition, skirt strut structure 2 and anchoring structure 3 cooperation are suitable for centre gripping autologous leaflet 4.

Compared with the prior technical scheme of anchoring by means of radial supporting force, the anchoring structure 3 is matched with the skirt support structure 2 to clamp the autologous valve leaflet 4 stably, so that the transcatheter replacement valve 10 is prevented from being displaced, and perivalvular leakage or other complications are avoided. In addition, because the skirt support structure 2 is located the atrium side of autologous leaflet 4, can the root of centre gripping autologous leaflet 4, the clamping effect is better for it is more stable after the valve release is replaced to the pipe.

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.

Further, referring to fig. 1-8, the stent body 1 has a first end and a second end disposed opposite to each other, and the first end of the stent body 1 is an upper end and also an inflow end as viewed in the orientation of fig. 2; the second end of the stent body 1 is the lower end and is also the outflow end. The first end of support main part 1 is located to the skirt strut structure 2, and the skirt strut structure 2 encircles support main part 1 a week and expands towards the outside of support main part 1. The outer ring of the skirt support structure 2 is larger than the diameter of the support body 1. After release of the transcatheter replacement valve stent, the skirt structure 2 is positioned in the left atrium 11, i.e. on the upper side of the native valve leaflet 4 of the patient. The outer side of the skirt support structure 2 towards the stent main body 1 is expanded, so that the clamping area of the skirt support structure 2 and the anchoring structure 3 to the autologous valve leaflet 4 can be enlarged, and the artificial valve 10 is anchored more stably.

Further, referring to fig. 1 to 8, the skirt structure 2 includes a first skirt section 21 connected to the stent body 1 and a second skirt section 22 connected to the first skirt section 21, the first skirt section 21 being outwardly curved and the second skirt section 22 being inwardly curved. In a preferred embodiment, the first skirt section 21 is smoothly connected with the stent body 1, and the first skirt section 21 is smoothly connected with the second skirt section 22. It should be noted that the first skirt section 21 is bent outward, that is, the first skirt section 21 is bent toward a side away from the center of the holder main body 1, and correspondingly, the second skirt section 22 is bent inward, that is, the second skirt section 22 is bent toward a side close to the holder main body 1. Thus, the first and second skirt sections 21 and 22 are bent in opposite directions. The skirt structure 2 may be visualized as a dish-type mesh support, as shown in fig. 1, 5 and 6, the skirt structure 2 providing support for the stitching of a flexible sealing skirt 9. The sealing skirt 9 will be described later. Referring to fig. 4, the second skirt section 22 can be bent to fit the myocardial tissue 13 or the atrial septum 14, thereby improving the sealing effect. A grid opening is arranged between the first skirt section 21 and the second skirt section 22 or between the second skirt section 22 and the stent main body 1.

Further, the anchoring structure 3 comprises a plurality of anchors 30 spaced around the periphery of the stent body 1, the anchors 30 being engaged with the skirt structure 2 for gripping the native valve leaflets 4.

Further, in the present embodiment, referring to fig. 1 to 8, the anchoring member 30 includes an anchoring rod 300, a first end of the anchoring rod 300 is connected to the stent body 1, and a second end of the anchoring rod 300 extends toward the skirt structure 2 and cooperates with the skirt structure 2 to clamp the native valve leaflets 4 when the ventricle contracts, thereby preventing the transcatheter replacement valve from being displaced and preventing paravalvular leakage.

In the orientation of fig. 2, the first end of anchor rod 300 is the lower end in fig. 2, and correspondingly, the second end of anchor rod 300 is the upper end in fig. 2. As mentioned above with reference to fig. 8, after the catheter replacement valve stent is released, the skirt structure 2 is located in the left atrium 11, i.e. at the upper portion of the native valve leaflet 4, the anchor rod 300 is located in the left ventricle 12, i.e. at the lower portion of the native valve leaflet 4, and the skirt structure 2 and the anchor rod 300 clamp the native valve leaflet 4 therebetween.

The skirt structure 2 is a ring-shaped frame structure, and the anchor rods 300 are provided 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 structure 2 and the anchor rods 300. As a preferred embodiment, the anchoring rods 300 are evenly spaced around the stent body 1 around its circumference, so that both the anterior cusp 42 and the posterior cusp 41 of the mitral valve can receive even clamping force, ensuring stable clamping. Referring to fig. 1 to 8, in the present embodiment, 12 anchoring rods 300 are provided, and in particular, the second ends of the anchoring rods 300 may extend to the mesh openings of the skirt support structure 2. The net mouth of skirt strut structure 2 has at least two skirt struts to play clamping action to autologous valve leaflet 4, compares in the scheme that single skirt strut of anchor rod 300 and skirt strut structure 2 corresponds cooperation centre gripping autologous valve leaflet 4, and the second end of anchor rod 300 extends to the net mouth department of skirt strut structure 2, has two skirt struts and anchor rod 300 cooperation centre gripping autologous valve leaflet 4 at least, and the centre gripping area is big, and the centre gripping is more stable. In addition, because the skirt support structure 2 is arranged at the first end of the stent main body 1, namely the upper end in fig. 2, and the second end of the anchoring rod 300 extends towards the skirt support structure 2, the skirt support structure 2 and the anchoring rod 300 can clamp the root of the autologous valve leaflet 4, compared with the radial supporting anchoring mode by the anchoring rod 300, the root of the autologous valve leaflet 4 clamped by the present embodiment can be clamped more stably, and the radial and axial displacement of the stent main body 1 along the replacement valve through the catheter is ensured not to easily occur.

Further, the second end of the anchor rod 300 is provided with a protective structure 5. Since the second end of the anchoring rod 300 is engaged with the skirt support structure 2 for gripping the autologous valve leaflets 4 of the patient. That is, the second end of the anchoring rod 300 directly contacts with the autologous leaflet 4 or the myocardial tissue 13 of the patient, and the protective structure 5 can effectively prevent the second end of the anchoring rod 300 from puncturing the autologous leaflet 4 or the myocardial tissue 13.

Specifically, referring to fig. 1 to 8, the protective structure 5 includes an expansion block 51 protruded from the anchor rod 300, and an outer contour of the expansion block 51 is a rounded curve. In order to reduce the size of the compressed stent for delivery, as a preferred embodiment, referring to fig. 7, the outer contour of the expansion block 51 is circular, and the expansion block 51 has a flat round-stem shape. The 12 expanding blocks 51 of the anchoring rods 300 surrounding the circumference of the stent main body 1 are all arranged facing one side of the center of the stent main body 1, so that when the stent main body 1 is unfolded, the second ends of the anchoring rods 300 do not stab myocardial tissues 13 or autologous valve leaflets 4, and when the stent main body 1 is pressed, the whole body of the transcatheter replacement valve stent has a smaller conveying size.

The mitral valve has an anterior tip 42 and a posterior tip 41, and referring to fig. 8, the anterior tip 42 is proximal to the interatrial septum 14, the posterior tip 41 is distal to the interatrial septum 14, and the posterior tip 41 is attached to the myocardial tissue 13. Therefore, the anchoring rod 300 near the anterior tip 42 does not have to take into account the problem of puncturing the myocardial tissue 13, while the anchoring rod 300 near the posterior tip 41 takes into account the problem of puncturing the myocardial tissue 13 and puncturing the native leaflets 4. To accommodate this physiological characteristic, the present embodiment, as a preferred embodiment, provides a differential arrangement of the anchor rods 300. Referring to fig. 1 to 8, in the present embodiment, 12 anchor rods 300 evenly spaced around the stent body 1 are divided into two groups, namely, a first clamping group 31 and a second clamping group 32, the first clamping group 31 is 6 anchor rods 300 near the front tip 42, and the second clamping group 32 is 6 anchor rods 300 near the rear tip 41. The first clamping group 31 is for clamping the anterior apex 42 of the mitral valve and the second clamping group 32 is for clamping the posterior apex 41 of the mitral valve. Since the front tip 42 does not have to consider the problem of puncturing the myocardial tissue 13, the second end of the anchor rod 300 provided in the first clamping group 31 is provided with the expansion block 51, and the expansion block 51 has a round-stem shape. The second ends of the anchoring rods 300 of the second clamping group 32 are bent toward the stent main body 1 to avoid puncturing the myocardial tissue 13 and the native valve leaflets 4, and a lightening hole may be formed in the middle of the expansion block 51 to reduce the overall weight of the transcatheter replacement valve stent.

Further, a reinforcing structure 6 is connected between adjacent two anchor rods 300. The reinforcing structure 6 can improve the strength of the anchoring rod 300 and the stability of anchoring, effectively prevent the anchoring rod 300 from deviating along the circumferential direction of the stent main body 1, avoid the coaxiality of the valve ring and the autologous valve ring from being influenced by the displacement of the valve through catheter replacement, and ensure the uniform distribution and the transverse stability of each anchoring rod 300, and when seen in the direction of fig. 2, the horizontal stability can be said, and the valve leakage caused by the displacement of the stent main body 1 is avoided.

Further, the reinforcing structure 6 includes a reinforcing rod 61, the reinforcing rod 61 is one or a combination of V-shaped, U-shaped and W-shaped, and two ends of the reinforcing rod 61 are respectively connected to two adjacent anchors 30. In this embodiment, the reinforcing bar 61 is V-shaped.

Furthermore, in the process of releasing the whole transcatheter replacement valve stent from the sheath, if the release position is not positioned accurately, the transcatheter replacement valve stent can be recovered, namely, the transcatheter replacement valve stent is integrally recovered into the sheath, and the transcatheter replacement valve stent is released again after the position is adjusted. In order to ensure that the entire transcatheter replacement valve stent can be smoothly recovered, in a compressed state, the tip of the V-shaped reinforcing rod 61 faces the same direction as the release direction of the transcatheter replacement valve stent. During release, the second end of the stent body 1 is released before the first end, i.e., the lower end of the stent body 1 is released before the upper end in fig. 2, and the tip of the V-shaped reinforcing rod 61 faces downward in the crimped state, i.e., when positioning inaccuracies require the retrieval of the transcatheter replacement valve stent into the sheath, the tip of the V-shaped reinforcing rod 61 faces downward.

Further, the transcatheter replacement valve stent is entirely radially compressed and received in the sheath. In order to reduce the transportation size, the first end of the anchor rod 300 is connected with the second end of the stent body 1, and is integrally formed by tooling heat treatment. Referring to fig. 19, in the crimped state, the second end of the single anchor rod 300 is folded around the first end of the anchor rod 300, so that the anchor rod 300 extends in the axial direction of the stent body 1, that is, the anchor rod 300 is in a straightened state without overlapping with the stent body 1 in the radial direction; in the unfolded state, the second end of the anchor rod 300 is turned over around the first end of the anchor rod 300 in the reverse direction, so that the anchor rod 300 overlaps the stent body 1 in the radial direction of the stent body 1. In the orientation of fig. 2, the tip of the V-shaped reinforcement 61 faces downward in the squeezed state, and after deployment, the anchor rod 300 is folded back outward around its first end to assume the state shown in fig. 2, i.e., the deployed state, in which the tip of the V-shaped reinforcement 61 faces upward.

Existing replacement valves rely on radial support to anchor, and to provide greater anchoring force, the overall radial dimension of the stent has to be increased, which can lead to conduction block; in addition, the stent is large in size after being crimped, so that the delivery resistance is increased, and the delivery of the instrument is difficult. In the invention, under the pressing and holding state, the anchoring rod 300 can be folded to extend along the axial direction of the stent main body 1, so that the transcatheter replacement valve stent has only a single layer under the pressing and holding state, the stent main body 1, the skirt support structure 2, the anchoring rod 300, the valve leaflet suture ear 8 and the conveying connection structure 7 are connected into a whole, the conveying size of the transcatheter replacement valve stent can be effectively reduced, the conveying process is ensured to be smoother, and the recoverability of the transcatheter replacement valve stent is ensured. It should be noted that "retrieving" here means that the released portion is again retracted into the sheath.

Further, the first end of the support main body 1 is provided with a conveying connection structure 7, the conveying connection structure 7 comprises a plurality of connecting rods 71 which are arranged around the support main body 1 in a circle, one ends of the connecting rods 71 are connected with the first end of the support main body 1, the other ends of the connecting rods 71 extend along the axial direction of the support main body 1 far away from the first end of the support main body 1, hanging parts 72 are arranged at the end parts of the connecting rods, and the hanging parts 72 are suitable for being connected with a conveying system. The hanging part 72 protrudes from the connecting rod 71, which is beneficial to providing an acting point for connecting with a conveying system, and meanwhile, the skirting structure 2 can be prevented from generating impact force in the releasing process, so that the anchoring part 30 is prevented from being displaced and even causing heart damage. In this embodiment, the connecting rods 71 are provided with six connecting rods, and are uniformly spaced around the bracket body 1, and the hanging parts 72 are cross rods perpendicular to the connecting rods 71. Of course, the hanging part 72 may be a ring or other structure protruding from the connecting rod 71.

Further, the stent body 1 is provided with a plurality of leaflet suture ears 8 around the circumference of the stent body 1. Referring to fig. 1, 5, 6 and 8, the leaflet suture ears 8 provide suture holes in the stent body 1 that provide support for suturing of a prosthetic valve 10 of a bio-or non-bio-flexible material.

Example 2

This embodiment provides a modified embodiment, which is different from embodiment 1 in that the second end of the anchor rod 300 is bent toward one side to constitute the shielding structure 5. The second end of the anchoring rod 300 is bent toward one side, so that the part of the anchoring rod 300 matched with the skirt support structure 2 is a bent part, but not the end part of the anchoring rod 300, that is, the bent part of the anchoring rod 300 is in direct contact with the autologous valve leaflet 4 or the myocardial tissue 13, and the autologous valve leaflet 4 or the myocardial tissue 13 cannot be punctured due to the fact that the bent part is a smooth curve, so that the protection effect is achieved.

In addition, with the second end of anchor rod 300 towards one side crooked, when cooperating with skirt strut structure 2, because anchor rod 300 has elastic deformation ability for the flexion can provide the clamping force towards support main part 1 inboard, and first skirt strut section 21 is crooked towards support main part 1 outside, and both set up relatively, cater for each other, thereby strengthen anchor rod 300 and skirt strut structure 2's clamping effect, make the centre gripping more stable.

In particular, with reference to fig. 9-17, the second end of the anchor rod 300 is bent inward, i.e. bent close to the stent body 1; or, the second end of the anchor rod 300 is bent outward, that is, away from the stent body 1.

Referring to fig. 9 and 10, in the present embodiment, the second ends of the 12 anchoring rods 300 are all bent toward the inner side of the stent body 1, and the bent arc line is a major arc.

Example 3

This embodiment provides a modified embodiment, and referring to fig. 11 and 12, the difference from embodiment 2 is that the second ends of 12 anchor rods 300 are bent toward the outside, and the arc line in which the second ends of the anchor rods 300 are bent is a major arc. Compared to the solution of embodiment 2 in which the anchor bar 300 is bent toward the inside, the second end of the anchor bar 300 is bent toward the outside in this embodiment, which is easier to form during the heat treatment, higher in production efficiency, and, when cooperating with the conveying system, the structure is more convenient to load and release.

Example 4

This embodiment provides a modified embodiment, and referring to fig. 13 to 15, the difference from embodiment 2 is 12 anchor rods 300, wherein 6 adjacent anchor rods 300 are the first clamping group 31 for clamping the front tip 42, and the other 6 anchor rods 300 are the second clamping group 32 for clamping the rear tip 41. To accommodate physiological differences in the anterior and posterior cusps 42, 41 of the mitral valve, the second ends of the anchor rods 300 of the first clamping group 31 are bent medially and the arc of the bend is a minor arc. The second end of the anchor rod 300 of the second clamping group 32 is bent inwardly and the arc of the bend is the major arc.

Of course, the second end of the anchor rod 300 may also be provided with an expansion block 51 while being bent, such as shown in fig. 1-8.

Example 5

This embodiment provides a modified embodiment, and referring to fig. 16 and 17, the difference from embodiment 3 is 12 anchor rods 300, wherein 6 adjacent anchor rods 300 are the first clamping group 31 for clamping the front tip 42, and the other 6 anchor rods 300 are the second clamping group 32 for clamping the rear tip 41. To accommodate the physiological differences of the anterior cusp 42 and the posterior cusp 41 of the mitral valve, the second ends of the anchor rods 300 of the first clamping group 31 are bent medially and the arc of the bend is a minor arc. The second end of the anchor rod 300 of the second clamping group 32 is bent to the outside, and the bent arc line is a major arc.

Of course, the anchoring structure 3 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, the transcatheter replacement valve further comprises a sealing skirt 9, the sealing skirt 9 being configured as shown in fig. 18. Referring to fig. 8, the sealing skirt cloth 9 is connected to the skirt support structure 2, the sealing skirt cloth 9 is fitted around the support body 1 to the inner side of the support body 1, the first end of the sealing skirt cloth 9 is connected to the skirt support structure 2, and the second end of the sealing skirt cloth 9 extends toward the second end of the support body 1.

Further, as a modified embodiment, as shown in fig. 20, the sealing skirt 9 may be further provided with a triangular extension 91 at the distal end to give a higher sealing effect, and the sealing skirt 9 is sewn on the stent body 1 at a position shown in fig. 21, and the triangular extension 91 of the sealing skirt 9 is fitted with the triangular window exposed by the diamond mesh of the stent body 1.

Furthermore, the transcatheter replacement valve stent also comprises a valve leaflet suture ear 8, and the second end part of the sealing skirt 9 partially or completely covers the valve leaflet suture ear 8, 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 connected with a prosthetic valve 10 through a valve leaflet suture ear 8 in a suture way; the prosthetic valve 10 is provided with two pieces adapted to replace the mitral valve of a patient; alternatively, the prosthetic valve 10 is provided with three pieces adapted to replace the patient's aortic valve; or, the artificial valve is provided with four pieces and is suitable for the heart valve of a special patient.

A percutaneous catheter is a catheter that is inserted into the skin with a needle. All catheters are hollow catheters that allow fluid to enter the body or allow excess fluid to be removed from the body through the catheter and into 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 14, and entering the left ventricle 12 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 12;

and step S3: adjusting the direction of the conveying system through the mark on the conveying system, enabling the second clamping group 32 of the anchoring rod 300 to turn to the back leaf surface, releasing the anchoring rod 300, adjusting the position to enable the anchoring rod 300 of the second clamping group 32 to push to the root part of the back leaf, enabling the anchoring rod 300 of the first clamping group 31 to push to the root part of the front leaf, continuously releasing the valve leaflet suture ear 8 and the skirt support structure 2 at the atrium end, enabling the skirt support structure 2 to support at the bottom of the atrium, and finally releasing the conveying connecting structure 7;

and step S4: the conveying system for the intervention mitral valve is withdrawn to the right atrium 11 and sent to the interatrial septum stopper to block the interatrial septum 14, 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 a way through the interatrial septum 14, the puncture ventricular septum establishes a guide wire track from the left ventricle 12 to the right ventricle, the guide wire is sent into the interventional transcatheter replacement valve device, the anchoring rod 300 is released, the sheath is withdrawn, and the artificial valve 10 is released. The atrial septum 14 is sealed and the procedure is over.

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

1. the skirt support structure 2 and the anchoring structure 3 are matched to form a clamping mechanism which can clamp the autologous valve leaflet 4, prevent the valve stent from displacing through a catheter and prevent the valve periphery from leaking;

2. the end part of the anchoring rod 300 is provided with the protective structure 5, which can effectively prevent the autologous valve leaflets 4 from being punctured or the myocardial tissues 13 from being punctured;

3. the anchoring elements 30 are divided into a first clamping group 31 and a second clamping group 32, which are respectively adapted to the anterior cusp 42 and the posterior cusp 41 of the mitral valve, and are arranged in a differentiated manner to be more adapted to the physiological characteristics of the mitral valve;

4. anchor rod 300 links as an organic whole with support main part 1, for support main part 1 and anchor rod 300 are single-layer construction when pressing and holding, have effectively reduced and have carried the size, are convenient for release and retrieve.

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 (20)

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;

fixture, surround the periphery setting of support main part (1), fixture including respectively with skirt strut structure (2) and anchor structure (3) that support main part (1) is connected, support main part (1) is in under the expansion state, skirt strut structure (2) and anchor structure (3) cooperation are suitable for centre gripping autologous leaflet (4).

2. The transcatheter replacement valve stent according to claim 1, wherein the skirt structure (2) is provided at the first end of the stent body (1), the skirt structure (2) encircling the stent body (1) around the circumference and expanding towards the outside of the stent body (1).

3. The transcatheter replacement valve stent according to claim 2, wherein the skirt structure (2) comprises a first skirt section (21) connected to the stent body (1) and a second skirt section (22) connected to the first skirt section (21), the first skirt section (21) being outwardly curvedly disposed and the second skirt section (22) being inwardly curvedly disposed.

4. The transcatheter replacement valve stent according to any one of claims 1-3, wherein the anchoring structure (3) comprises a plurality of anchors (30) spaced around the circumference of the stent body (1), the anchors (30) cooperating with the skirt structure (2) for gripping native valve leaflets (4).

5. The transcatheter replacement valve stent according to claim 4, wherein the anchor (30) comprises an anchor rod (300), a first end of the anchor rod (300) being connected to the stent body (1), a second end of the anchor rod (300) extending towards the skirt structure (2) and cooperating with the skirt structure (2) for gripping a native valve leaflet (4).

6. The transcatheter replacement valve stent according to claim 5, wherein the second end of the anchoring rod (300) is provided with a protective structure (5).

7. The transcatheter replacement valve stent according to claim 6, wherein the protective structure (5) comprises an expansion block (51) protruding from the anchoring rod (300), the outer contour of the expansion block (51) being a rounded curve.

8. The transcatheter replacement valve stent according to claim 6, wherein the second end of the anchoring rod (300) is bent towards one side constituting the guard structure (5).

9. The transcatheter replacement valve stent according to claim 8, wherein the second end of the anchoring rod (300) is bent close to the stent body (1); or, the second end of the anchor rod (300) is bent away from the stent body (1).

10. The transcatheter replacement valve stent of claim 9, wherein the second end of the anchoring rod (300) is curved in an arc that is a major arc to accommodate the posterior apex of the mitral valve; or, the second end of the anchoring rod (300) is curved in a minor arc to accommodate the anterior cusp of the mitral valve.

11. The transcatheter replacement valve stent of claim 10, wherein the plurality of anchors (30) are divided into a first clamping group (31) and a second clamping group (32), the second ends of the anchor rods (300) of the first clamping group (31) being bent close to the stent body (1), the second ends of the anchor rods (300) of the second clamping group (32) being bent away from the stent body (1).

12. The transcatheter replacement valve stent according to any one of claims 5-11, wherein a reinforcement structure (6) is connected between two adjacent anchor rods (300).

13. The transcatheter replacement valve stent according to claim 12, wherein the reinforcing structure (6) comprises a reinforcing rod (61), the reinforcing rod (61) being a combination of one or more of V-shaped, U-shaped, W-shaped, the ends of the reinforcing rod (61) being connected to two adjacent anchors (30), respectively.

14. The transcatheter replacement valve stent according to any one of claims 5-13, wherein a first end of the anchoring rod (300) is connected with a second end of the stent body (1), the anchoring rod (300) not overlapping the stent body (1) in a radial direction of the stent body (1) in a crimped state of the stent body (1).

15. The transcatheter replacement valve stent according to any one of claims 1-14, wherein the stent body (1) is provided at a first end thereof with a delivery connection structure (7), the delivery connection structure (7) comprises a plurality of connecting rods (71) arranged around the stent body (1), one ends of the connecting rods (71) are connected with the first end of the stent body (1), the other ends of the connecting rods (71) extend away from the first end of the stent body (1) in the axial direction of the stent body (1), and a hanging part (72) is arranged at the end part, and the hanging part (72) is adapted to be connected with a delivery system.

16. The transcatheter replacement valve stent according to any one of claims 1-15, wherein the stent body (1) is provided with a plurality of leaflet suture ears (8) around the circumference of the stent body (1).

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

18. The transcatheter replacement valve device according to claim 17, wherein a sealing skirt (9) is connected to the skirt structure (2), the sealing skirt (9) being snugly provided inside the stent body (1) around a circle of the stent body (1), a first end of the sealing skirt (9) being connected to the skirt structure (2), a second end of the sealing skirt (9) extending towards the second end of the stent body (1).

19. The transcatheter replacement valve device according to claim 18, wherein the transcatheter replacement valve stent further comprises a leaflet suture ear (8), the second end of the sealing skirt (9) partially or completely covering the leaflet suture ear (8).

20. The transcatheter replacement valve device according to any one of claims 17-19, wherein the transcatheter replacement valve stent further comprises a leaflet suture ear (8), wherein a prosthetic valve (10) is sutured to the inside of the stent body (1) at the leaflet suture ear (8); the prosthetic valve (10) is provided with two pieces adapted to replace the mitral valve of a patient; or, the prosthetic valve (10) is provided with three pieces, adapted to replace the aortic valve of a patient; or the artificial valve (8) is provided with four pieces and is suitable for the heart valve of a special patient.

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