CN117695060A

CN117695060A - Transcatheter valve stent

Info

Publication number: CN117695060A
Application number: CN202311718764.XA
Authority: CN
Inventors: 金昌�; 李柯
Original assignee: Xinyi Medical Technology Beijing Co ltd
Current assignee: Xinyi Medical Technology Beijing Co ltd
Priority date: 2023-12-14
Filing date: 2023-12-14
Publication date: 2024-03-15

Abstract

The invention provides a transcatheter valve stent, which relates to the technical field of medical appliances and comprises a grid cylindrical stent body and an anchoring structure; the grid cylindrical support body comprises an inflow support section, a main support section and an outflow support section; the inflow bracket section comprises a limit section with the outer diameter larger than the outer diameter of each part of the inner main body bracket section; the anchoring structure comprises barbs, and the axial direction of the grid cylindrical support body is along: the barb is in a closed ring shape, the far end of the barb is connected with the main body support section or the outflow support section, and the near end of the barb extends to the main body support section and extends outwards along the radial direction of the main body support section. The invention relieves the problems of difficult anchoring of the TMVR valve, easy blockage of the outflow passage of the left chamber, easy occurrence of paravalvular leakage and the like in the prior art, and reduces the delivery diameter of the valve.

Description

Transcatheter valve stent

Technical Field

The invention relates to the technical field of medical instruments, in particular to a transcatheter valve stent.

Background

Heart valves are important components of the heart, for example, the mitral valve, which is located between the left atrium and the left ventricle, which receives oxygen-enriched blood from both lungs, flows through the mitral valve into the left ventricle, and is then pumped throughout the body. Mitral valve architecture includes four parts, including leaflet, annulus, chordae, papillary muscles, any one or more of which may be dysstructural or dysfunctional, resulting in mitral insufficiency. When the left ventricle contracts, blood flows back into the left atrium, creating mitral regurgitation. Mitral regurgitation affects the quality of life of the patient and, in severe cases, can endanger the patient's life.

Transcatheter mitral valve replacement (Transcatheter Mitral Valve Replacement, TMVR), is a method of using catheter intervention to compressively load a prosthetic mitral valve in vitro into a delivery system, deliver it along a vascular path or puncture tip to the native mitral valve annulus, and releasably secure the prosthetic valve prosthesis at the mitral valve annulus to replace the native valve, restoring the normal function of the mitral valve.

The path progress of TMVR is relatively slow, presenting a great challenge, mainly in the following aspects:

(1) Difficulty in anchoring valve

Since most mitral valve annulus tissues have no obvious calcification, the valve annulus changes dynamically, the pressure in the left ventricular systole cavity is huge, and the fixation is difficult.

(2) Left Ventricular Outflow Tract (LVOT) is prone to blockage

The mitral valve prosthesis presses against the aorta, resulting in a reduced left ventricular outflow tract opening area, an increased pressure gradient, and reduced left ventricular emptying, resulting in reduced cardiac output.

(3) Easily cause the problem of perivalvular leakage

The mitral valve annulus is a dynamic saddle-shaped structure that assumes a D-shape and dynamically changes as the heart muscle contracts and relaxes, which anatomical feature tends to lead to problems with paravalvular leakage, while, in order to reduce LVOT obstruction, a short valve frame and waisted design is required, which in turn necessarily leads to an increased likelihood of paravalvular leakage of the implanted mitral valve prosthesis.

(4) Valve delivery diameter is larger

Because the whole valve of the mitral valve is large and various external anchoring structures of the valve are arranged, the delivery diameter of the compressed mitral valve is overlarge when the valve is implanted.

Disclosure of Invention

The present invention aims to provide a transcatheter valve stent, which alleviates the above-mentioned technical problems in the prior art.

In order to achieve the above purpose, the embodiment of the present invention adopts the following technical scheme:

the embodiment of the invention provides a transcatheter valve stent, which comprises a grid tubular stent body and an anchoring structure;

the grid cylindrical support body comprises an inflow support section, a main support section and an outflow support section; the proximal end of the outflow stent segment is connected to the distal end of the main body stent segment; the distal end of the inflow stent section is connected to the proximal end or a part close to the proximal end of the main body stent section; the inflow bracket section comprises a limit section with the outer diameter being larger than the outer diameter of each part of the main bracket section; the peripheral surface of the inflow bracket section is connected with an inflow section sealing skirt; the circumference of the main body support section is connected with a sealing skirt;

the anchoring structure comprises barbs, and the axial direction of the grid cylindrical support body is along: the barb is in a closed ring shape, the far end of the barb is connected with the main body support section or the outflow support section, and the near end of the barb extends to the main body support section and extends outwards along the radial direction of the main body support section.

In some alternative embodiments, the transcatheter valve stent may be used alone, with artificial leaflets attached to the inside of its sealing skirt; in other alternative embodiments, the transcatheter valve stent described above may also be used as an external stent in combination with an internal stent graft: an inner covered stent is connected in the outflow stent section, an artificial valve leaflet is connected at the inner side of the covered film of the inner covered stent, and the covered film of the inner covered stent is connected with the sealing skirt of the inflow section or the sealing skirt of the circumferential surface of the main stent section so as to prevent leakage between the inner covered stent and the transcatheter valve stent, wherein the inner covered stent is preferably a cylindrical covered stent; when the covering film of the covering film inner bracket is connected with the sealing skirt on the circumferential surface of the main bracket section, the connecting part is positioned at the far end of the sealing skirt, so that the surface area of the connecting part material is reduced while the leakage is prevented, the valve can be more easily received, and the formation of larger blood flowing dead angles is avoided on the outer circumferential surface of the opening side of the valve leaf, thereby reducing the possibility of thrombus formation. In addition, the device can be used as a separate stent to be implanted into a body in advance, and then any valve without an anchoring unit which can be expected to be matched (such as a conventional balloon-expanded interventional aortic valve) is implanted, so that a valve-in-valve structure is realized.

When the device is used, a conveyor comprising an outer tube, a supporting inner tube, a bracket far-end restraint and a bracket near-end restraint is selected, the bracket near-end restraint can be arranged independently of the outer tube, the supporting inner tube and the bracket far-end restraint, for example, a restraint wire or a restraint film sleeve and other structures are used, the device can also comprise a push-pull tube penetrating through the lumen of the supporting inner tube and a guide head connected to the front end of the push-pull tube, and a concave restraint groove is formed in the end face of the rear end of the guide head; the far-end restraint part of the bracket can be arranged independently of the outer pipe, the inner supporting pipe and the near-end restraint part of the bracket, and can also be directly fixed at the front end of the inner supporting pipe;

during assembly, the transcatheter valve stent is radially compressed in a front side space positioned at the front end of the supporting inner tube in the outer tube in a mode that the inflow stent section of the stent faces forwards and the outflow stent section faces backwards, so that barbs of the transcatheter valve stent are radially compressed in the outer tube, the inflow stent section of the transcatheter valve stent is radially restrained by a proximal restraint (the proximal restraint can also radially restrain the proximal end position of the main body stent section but the proximal restraint cannot restrain the barbs), and the distal end of the outflow stent section of the transcatheter valve stent is axially restrained by a distal restraint;

Then, pushing the front end of the conveyor to a specified position from the direction of a ventricle to an atrium, enabling a proximal restraint to pass through an annulus to enter the atrium, enabling the proximal end of a barb to stay in the ventricle, at the moment, withdrawing the outer tube, releasing the barb, expanding the barb, pushing the conveyor forward integrally, driving the transcatheter valve support to push forward until obvious resistance exists, enabling the barb to prop against the annulus, at the moment, releasing the restraint of the proximal restraint on the inflow support section, enabling the inflow support section to be released in the atrium, and enabling a limit section with the outer diameter larger than the outer diameter of each part of the main support section to prevent the inflow support section from entering the ventricle from the atrium;

finally, the restriction of the distal end restriction piece on the distal end of the outflow stent section is released, the outflow stent section is released in the ventricle, the transcatheter valve stent completely recovers the original shape, and the whole conveyor is withdrawn from the patient.

If a transfemoral approach is used, the release logic is similar to that described above, and the barbs are released first, and the inflow stent segment is released after the transcatheter valve stent is moved proximally as a whole, and when the transcatheter valve stent is used for the tricuspid valve, the release logic is similar depending on the implantation path.

The above-mentioned through pipe valve support overall structure that this embodiment provided is simple, the transportation process is convenient, more importantly, when it implants in the patient, the barb grabs earlier and blocks the lamella She Yiyu and prevent to release the in-process through pipe valve support aversion, after the release, support the valve annulus through the barb and further prevent the aversion after the valve implantation, the anchoring is simple and fix a position accurately, the emergence of all kinds of aversions has been prevented, on this basis, the spacing section of inflow support section external diameter more than main part support section everywhere external diameter can prevent to inflow support section from entering into the ventricle from the atrium, with barb and barb cooperation fully prevent the problem that the valve periphery leaks appear.

In addition, in this embodiment, the barb is designed in a closed loop shape, so that the damage of the barb to the annulus, the native valve leaflet and the native heart tissue of the patient can be reduced, wherein in this embodiment, preferably, the proximal end of the barb is rounded with less damage to the patient. The proximal end of the barb extends outwards along the radial direction of the main body stent section, so that when the barb is released, the barb is outwards opened by a larger angle, the grabbing of the barb to the native valve leaflet in the process of releasing the transcatheter valve stent is facilitated, and the operation is simplified; meanwhile, the extrusion of the native tissue to the free end (proximal end) of the barb is easy to enable the barb to form a conical structure, so that the positioning of the transcatheter valve stent in a ventricle is realized, and the movement of the stent to the atrial side is reduced.

According to the technical scheme, the anchoring of the transcatheter valve stent is achieved, the operability of the transcatheter valve stent releasing process is improved to the greatest extent, the valve shifting problem possibly occurring in the releasing process and after the releasing process is solved, and meanwhile, the barb structure is matched with the structural design of the inflow stent section, so that the sealing and positioning of the transcatheter valve stent are improved.

For the other problems in the prior art described above, solutions can be obtained in some alternative implementations of the present embodiment:

In some alternative implementations of the present embodiment, one of the body stent segment and the outflow stent segment that is connected to the barb is a barb connection segment; among them, more preferable is: the relative positions of the barbs and the barb connection sections satisfy: and in the radial shrinkage state of the grid cylindrical support body, the barbs are respectively positioned in different cell hollowed areas in the circumferential direction of the barb connecting section.

Further preferably, the barb and the grid cylindrical support body are formed by cutting the same pipe fitting by laser; in the radial shrinkage state of the grid cylindrical support body: the axial height of the cell hollowed-out area of the barb is larger than the axial height of the cell hollowed-out area of other areas of the grid cylindrical support body.

Still further preferably, in the mesh tube-shaped stent body, at least the main stent section and the outflow stent section are mesh stents each having a diamond-shaped cell. Wherein, for each cell where the barb is located: two inclined support beams which are combined into a V shape and flow out of the cells at the furthest end of the support section in the same axial direction are combined with two inclined support beams which are combined into an inverted V shape and flow out of the cells at the near end of any cell of the main support section, and the inclined support beams are butted, and the butted diamond-shaped middle area is left empty; the distal ends of the barbs are connected between two inclined support beams combined into a V shape at the most distal unit cell of the outflow support section.

Furthermore, in some alternative implementations of the present embodiment, it is preferable that the distal end of each of the barbs is connected to the support beam of the barb connection section by a respective transition beam;

and/or, the barbs are arranged in series and are arranged on each cell in the same circumferential direction of the barb connection section;

and/or the barb is in a structure which is turned outwards in radial direction relative to the barb connection section; and the included angle between the distal end section of the barb and the axial direction of the grid cylindrical support body is B1, and the included angle between the proximal end section of the barb and the central axis of the barb connecting section is B2, then: b1 > B2 is more than or equal to 0.

In some alternative implementations of this embodiment, it is more preferable that the radial plane at the distal-most end of the inflow stent section is an annulus plane, and the axial spacing between the proximal ends of the barbs and the annulus plane is 0.5mm-5mm; the proximal ends of the barbs extend radially outwardly from the body stent segment a radial length of 1mm to 8mm.

In some alternative implementations of this embodiment, it is preferred that the anchoring structure further comprises barbs; the barb distal end is connected to the body support section and the barb proximal end extends radially outwardly along the body support section.

Further preferably, the barb is provided with two layers along the axial direction, and the included angle between the barb and the axial direction is 10-60 degrees.

In some alternative implementations of this embodiment, it is preferred that the outer diameter of the distal section of the inflow stent section decreases from the proximal end to the distal end.

In some optional implementations of the present embodiment, more preferably, the main body support section includes a proximal section, a middle section and a distal section that are connected to each other, and the outer diameter of the proximal section of the main body support section gradually increases from the proximal end to the distal direction, the outer diameter of the distal section of the main body support section gradually decreases from the proximal end to the distal direction, and if the axial length of the middle section of the main body support section front She Ce is L1 and the axial length of the middle section of the main body support section rear She Ce is L2, then 0.ltoreq.l1 < L2;

and/or, with the included angle between the outer peripheral surface of the front She Ce of the inflow support section and the horizontal being A1, and with the included angle between the outer peripheral surface of the rear She Ce of the inflow support section and the horizontal being A2, then: a1 > A2.

In some alternative implementations of the present embodiment, it is preferable that the radial cross-sectional outer profile of the inflow stent section is D-shaped with a flatter section being front She Ce and an arcuate section being rear She Ce; the radial section outer contour of the outflow bracket section is circular; and/or the distal end of the outflow bracket section is provided with a conveying fixed claw.

In some alternative implementations of this example, the inflow stent section has a hardness < the main body stent section has a hardness < the outflow stent section.

In some alternative implementations of this embodiment, the inflow segment seal skirt is disposed on an outer circumferential surface of the inflow housing segment. And/or: the outer peripheral surface of the main body support section is also connected with a peripheral sealing skirt, and the peripheral sealing skirt is positioned on the inner side of the anchoring structure.

In particular, in the context of the present invention, the foregoing "and/or" means "and/or" preceding structures are either simultaneously or alternatively arranged with "and/or" following structures.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic overall structure of a first alternative structure of a transcatheter valve stent according to an embodiment of the present invention (sealing skirt not shown);

FIG. 2 is a view of the transcatheter valve stent of FIG. 1 from the proximal end in a distal direction (sealing skirt not shown);

FIG. 3 is a front view of a half-frame (sealing skirt not shown) taken through a first alternative configuration of the catheter valve stent along line A-A of FIG. 2;

FIG. 4 is a schematic view of the initial position of the connection of the distal ends of barbs to the body of the lattice cylindrical stent in the transcatheter valve stent structure of FIGS. 1-3;

FIG. 5 is a schematic view of the overall structure of a second alternative configuration of a transcatheter valve stent according to an embodiment of the present invention (sealing skirt not shown);

FIG. 6 is a view of the transcatheter valve stent of FIG. 5 from the proximal end looking in a distal direction (sealing skirt not shown);

FIG. 7 is a front view of a half-frame (sealing skirt not shown) taken through a second alternative configuration of the catheter valve stent along line B-B of FIG. 6;

FIG. 8 is a schematic view of the initial position of the connection of the distal ends of barbs to the mesh tubular stent body in the transcatheter valve stent structure of FIGS. 5-6;

FIG. 9 is a front view of a transcatheter valve stent with an inflow segment sealing skirt and a peripheral sealing skirt attached thereto, in accordance with an embodiment of the present invention;

fig. 10 is a schematic view of an assembly structure with an inner frame (sealing skirt is not shown) when the transcatheter valve stent according to the embodiment of the present invention is used as an outer stent;

FIG. 11 is a view of the assembled structure of FIG. 10 from the proximal end in a distal direction (sealing skirt not shown);

FIG. 12 is a front view of the mounting structure taken along line C-C of FIG. 11 (sealing skirt not shown);

FIG. 13 is a schematic view of the overall structure of the inner frame of FIG. 10 (sealing skirt not shown);

FIG. 14 is a schematic view of the catheter valve stent with a sealing skirt attached thereto from the perspective of FIG. 11;

fig. 15 is a schematic view showing a first step of implanting the transcatheter valve stent according to the present embodiment;

FIG. 16 is an enlarged view of the portion of the structure at the location D in FIG. 15;

FIG. 17 is a schematic view showing a second step of implanting the transcatheter valve stent according to the present embodiment;

FIG. 18 is an enlarged view of the portion of FIG. 17 at E;

FIG. 19 is an axially extending profile view of an overall peripheral surface of a transcatheter valve stent according to the present embodiment;

figure 20 is a schematic view of the angle between the barb and the central axis of the barb connection.

Icon: 100-a grid cylindrical bracket body; 110-inflow stent sections; 120-a main body stent section; 130-outflow stent sections; 140-conveying fixed claws; 151-inflow segment seal skirt; 152-peripheral sealing skirt; 153-sealing skirt; 210-barbs; 2101-transition beams; 211-first barbs; 212-a second barb; 213-third barb; 214-fourth barbs; 220-barb; 300-tectorial membrane internal support; 41-an outer tube; 42-supporting the inner tube; 43-stent proximal constraint; 44-stent distal constraint.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It should be noted that: like reference numerals and letters designate like items in the drawings, and thus once an item is defined in one drawing, no further definition or explanation thereof is necessary in the subsequent drawings.

In the description of the present invention, it should be noted that the terms "proximal," "distal," "inner," "outer," and the like indicate an orientation or a positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the inventive product is conventionally put in use, merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or element in question must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance. In particular, in the present invention, after implantation, the upstream in the blood flow direction is the "proximal end", and the downstream in the blood flow direction is the "distal end".

In the description of the present invention, it should also be noted that, unless explicitly specified and limited otherwise, the terms "disposed," "mounted," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

Some embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following embodiments and features of the embodiments may be combined with each other without conflict.

The present embodiment provides a transcatheter valve stent, which includes a mesh tubular stent body 100 and an anchoring structure, with reference to fig. 1 to 9, such that after implantation, the upstream in the blood flow direction is the "proximal end" and the downstream in the blood flow direction is the "distal end"; the mesh tube stent body 100 includes an inflow stent section 110, a main stent section 120, and an outflow stent section 130; the proximal end of outflow stent section 130 is connected to the distal end of main body stent section 120; the distal end of the inflow stent section 110 is connected to the proximal end of the main body stent section 120 or to a location on the main body stent section 120 near the proximal end of the main body stent section 120. When the distal end of the inflow stent section 110 is connected to a location on the main body stent section 120 near the proximal end, the proximal end of the main body stent section 120 may be parallel to the distal end of the inflow stent section 110 or may pass radially inward through the proximal end of the inflow stent section 110. The peripheral surface of the inflow bracket section 110 is connected with an inflow section sealing skirt 151; a sealing skirt 153 is attached to the perimeter of the body support section 120, wherein the inflow section sealing skirt 151 is preferably attached to the perimeter of the inflow support section 110 and is preferably, but not limited to, a fluffy skirt.

Wherein the inflow stent section 110 comprises a spacing section having an outer diameter greater than the outer diameter of the main body stent section 120 everywhere; the anchoring structure then comprises barbs 210, along the axial direction of the mesh tubular stent body 100: the barb 210 is in a closed ring shape, which is not a ring, but can be an elliptical ring, a square ring or other regular or irregular closed rings; the distal ends of barbs 210 are connected to the body stent segment 120 or the outflow stent segment 130, and the proximal ends of barbs 210 extend into the body stent segment 120 and extend radially outward along the body stent segment 120.

In some alternative implementations of this embodiment, the transcatheter valve stent described above may be used alone with artificial leaflets attached to the inside of its sealing skirt 153; the stent can also be used as an outer stent and a covered inner stent, and specifically, as shown in fig. 10 to 14: an inner stent graft 300 is connected to the inside of the outflow stent segment 130, artificial leaflets are connected to the inner side of the stent graft 300, and the stent graft of the inner stent graft 300 is connected to the inflow segment sealing skirt 151 or the sealing skirt 153 on the circumferential surface of the main stent segment 120, so that leakage between the inner stent graft 300 and the transcatheter valve stent is prevented, and the inner stent graft 300 is preferably a cylindrical stent graft as shown in fig. 13; when the covering membrane of the covered stent 300 is connected with the sealing skirt 153 of the circumferential surface of the main body stent section 120, the connection part is positioned at the far end of the sealing skirt 153 of the main body stent section, the surface area of the material of the connection part is reduced while the leakage is prevented, so that the valve can be more easily received, and the formation of a larger blood flow dead angle is avoided on the outer circumferential surface of the opening side of the valve leaflet, thereby reducing the possibility of thrombus formation. In addition, the above-mentioned transcatheter valve stent can also be used as a separate stent to be implanted into the body in advance, and then any valve (such as a conventional balloon-expanded interventional aortic valve) without an anchoring unit which can be expected to be matched is implanted, so that a valve-in-valve structure is realized.

In use, as shown in fig. 15 to 18, the illustrated type conveyor is selected: the device comprises an outer tube 41, a supporting inner tube 42, a bracket distal end restraint 44 and a bracket proximal end restraint 43, wherein the bracket proximal end restraint 43 can be arranged independently of the outer tube 41, the supporting inner tube 42 and the bracket distal end restraint 44, for example, a restraint wire or a restraint film sleeve and other structures are used, and the device can also comprise a push-pull tube penetrating through the tube cavity of the supporting inner tube 42 and a guide head connected to the front end of the push-pull tube, wherein the end face of the rear end of the guide head is provided with a concave restraint groove; the distal bracket restraint member 44 may be provided independently of the outer tube 41, the inner support tube 42 and the proximal bracket restraint member 43, or may be directly fixed to the front end of the inner support tube 42 as shown in fig. 15 to 18, and may be a fixed sleeve or a fixed hook;

during assembly, the transcatheter valve stent is radially compressed in the outer tube 41 in a manner that the stent inflow stent section 110 faces forward and the stent outflow stent section 130 faces backward, so that the barbs 210 of the transcatheter valve stent are radially compressed in the outer tube 41, the inflow stent section 110 of the transcatheter valve stent is radially restrained by the stent proximal restraining element 43 (the stent proximal restraining element 43 can also radially restrain the proximal end position of the main body stent section 120 but the stent proximal restraining element 43 cannot restrain the barbs 210), and the distal end of the transcatheter valve stent outflow stent section 130 is axially restrained by the stent distal restraining element 44;

Then, the front end of the conveyor is pushed to a designated position from the ventricular atrial direction, the proximal constraint element passes through the valve annulus to enter the atrium, the proximal end of the barb 210 stays in the ventricle, at this time, as shown in fig. 15 and 16, the outer tube 41 is withdrawn, the barb 210 is released, the barb 210 is expanded, then the conveyor is pushed forward as a whole, the transcatheter valve stent is driven to push forward until obvious resistance exists, the barb 210 can prop against the valve annulus, at this time, the constraint of the proximal constraint element on the inflow stent segment 110 is released in the atrium, and the inflow stent segment 110 can be prevented from entering the ventricle from the atrium by the limiting section with the outer diameter larger than the outer diameter of the main stent segment 120 at all positions;

finally, as shown in fig. 17 and 18, the distal end constraint of the outflow stent segment 130 is released, the outflow stent segment 130 is released into the ventricle, the transcatheter valve stent is fully restored to its original configuration, and the entire delivery device is withdrawn from the patient.

If a transfemoral approach is used, the release logic is similar to that described above, and the barbs 210 are released first, and the inflow stent segment 110 is released after the transcatheter valve stent has been moved proximally as a whole, and the release logic is similar when the transcatheter valve stent is used with the tricuspid valve, depending on the implantation path.

The above-mentioned through pipe valve support overall structure that this embodiment provided is simple, the transportation process is convenient, more importantly, when it is implanted in the patient, barb 210 grabs earlier and blocks valve She Yiyu and prevent to release the in-process through pipe valve support aversion, after the release, support the valve annulus through barb 210 and further prevent the aversion after the valve is implanted, the anchoring is simple and the location is accurate, the emergence of all kinds of aversions has been prevented, on this basis, inflow support section 110 external diameter is greater than the spacing section of main part support section 120 external diameter everywhere, can prevent inflow support section 110 from entering into the ventricle from the atrium, with barb 210 cooperation fully prevent the problem that the perivalvular leaks appear.

In addition, in this embodiment, the barb 210 is of a closed annular design that reduces damage to the patient's annulus, native valve leaflets, and native heart tissue from the barb 210, wherein the proximal end of the barb 210 is preferably rounded with less damage to the patient. The proximal end of the barb 210 extends radially outwards along the main body stent section 120, so that when the barb 210 is released, the barb 210 opens outwards by a larger angle, thereby facilitating the grabbing of the barb 210 on the native valve leaflet in the process of releasing the transcatheter valve stent, and simplifying the operation; meanwhile, the extrusion of the native tissue to the free end (proximal end) of the barb 210 tends to cause the barb 210 to form a tapered structure, thereby achieving positioning of the transcatheter valve stent in the ventricle and reducing movement of the stent to the atrial side.

The above-mentioned technical solution of the present embodiment maximizes the operability of the transcatheter valve stent releasing process and the valve displacement problem that may occur during and after the releasing process while realizing the transcatheter valve stent anchoring, and at the same time, the barbs 210 cooperate with the structural design of the inflow stent section 110, increasing the sealing and positioning of the transcatheter valve stent.

In more detail:

in this embodiment, one of the main body support section 120 and the outflow support section 130 connected to the barb 210 is a barb connection section; among them, more preferable is:

(1) The relative positions of the barbs 210 and barb connection segments satisfy: in the radially contracted state of the mesh tubular stent body 100, each barb 210 is respectively located in different cell hollowed-out areas in the circumferential direction of the barb connecting section, and the arrangement mode comprises, but is not limited to, that when a pipe is cut, the spacing between the cells is controlled; the design can ensure that when the barb 210 and the grid tubular stent body 100 are radially compressed in the outer tube 41 during assembly, the barb 210 is not radially added with any stent beam of the grid tubular stent body 100, and does not independently occupy the diameter of the compressed catheter valve stent, so as to maximally reduce the delivery diameter of the compressed catheter valve stent, minimize the diameter of the valve stent, and be beneficial to reducing the overall outer diameter of the outer tube 41 of the delivery device, thereby solving the problem of large valve delivery diameter in the prior art, and achieving the effects of being more convenient to deliver and reducing the damage to the vascular and organ tissues of a patient;

In this preferred embodiment, it is further preferred, but not limited to, that the barbs 210 are laser cut from the same tube as the mesh tube stent body 100, and that the mesh tube stent body 100 is in a radially contracted state: the axial height of the cell hollowed-out area provided with the barb 210 in the barb connecting section is larger than that of the cell hollowed-out areas in other areas of the grid cylindrical support body 100, and the design can further ensure that the axial length is longer and the opening angle is larger after the barb 210 is opened under the action of the support force of the support body so as to increase the anchoring effect; wherein, still more preferably, in the grid cylindrical stent body, at least the main stent section 120 and the outflow stent section 130 are grid stents with diamond-shaped unit cells; wherein for each cell where each barb 210 is located: two inclined support beams which are combined into a V shape from the most far end cells of the outflow support section 130 and two inclined support beams which are combined into an inverted V shape from the near end of any cell of the main support section 120 are butted in the same axial direction, and the butted diamond middle area is left to be manufactured; the distal ends of barbs 210 are connected between two diagonal stent beams combined into a "V" shape that flow out of the distal-most cells of stent segment 130;

The above preferred structure makes it easier to make the barb 210 perform structural layout on the mesh tubular stent body 100, and is easier to manufacture, and at the same time, it is easy to adjust the number of the integral barb 210 by controlling the number of the oblique stent beams combined into a V-shape in the circumferential direction, the increase of the barb 210 can make the anchoring more stable after the release of the catheter valve stent into the patient, two oblique stent beams combined into a V-shape from two cells at the farthest end of the stent section 130 in the axial direction are combined with two oblique stent beams combined into an inverted V-shape from two oblique stent beams at the proximal end of any cell of the main stent section 120, and the diamond middle area after the butt joint is left, so that the axial length and layout of the barb 210 are better. Wherein, the barbs 210 can be continuously arranged between every two inclined support beams combined into a V shape in the circumferential direction of the distal end of the outflow support section 130, or can be arranged in every other V shape combination, or can be arranged in other circumferential layout according to actual requirements, wherein, if continuously arranged, the anchoring effect is best; if spaced apart, the strength of the transcatheter valve stent can be maximized, especially in the case where the leaflets are disposed directly inside the transcatheter valve stent, the structure can maximize the stent strength, improving stent durability.

(2) As shown in fig. 4, the distal end of each barb 210 is connected to the support beam of the barb connection section by a transition beam 2101. The structure of the transition beam 2101 is easy to reduce the overall outward expanding rigidity of the barb 210, and when the outflow stent section 130 is changed from a radial constraint state to a released state by the conveyor during release, the whole barb 210 is outwards expanded by a larger angle under the drive of the outflow stent section 130 which is radially constrained;

and/or, as shown in fig. 20, the barb 210 is in a radially-everted configuration relative to the barb connection segment; and the included angle between the distal end section of the barb 210 and the axial direction of the mesh tubular stent body 100 is B1, and the included angle between the proximal end section of the barb 210 and the central axis of the barb connection section is B2, then: b1 is larger than B2 and is larger than or equal to 0, and the structure enables each barb 210 to have larger outward expansion amplitude when being opened, so that the proximal end of the barb 210 is closer to the root of an annulus after being implanted, the anchoring effect of the barb 210 is enhanced, and meanwhile, the distal end of the barb 210 is not damaged to the organ tissues of a patient by puncturing the ventricle; overall, the greater the angle B (B1 and B2) and the outward extension of the barb 210, the greater the angle at which the barb 210 flares during release, and the easier it is to operate, while the greater the distance at which the barb 210 extends outward, the more pronounced the taper of its free end (proximal end) deformation, the more beneficial it is to increase valve anchoring and reduce paravalvular leakage.

(3) The barbs 210 are arranged in series on each cell in the same circumferential direction of the barb connection section; the specific number of the barbs 210 is not limited, and may be set according to actual needs, for example, as shown in fig. 2, 6 and 11, the barbs 210 include a first barb 211 and a second barb 212 respectively disposed at two ends of the anterior leaflet side of the transcatheter valve stent, a third barb 213 and a fourth barb 214 respectively disposed between two ends of the anterior leaflet side of the transcatheter valve stent and respectively near the middle portion, and a fifth barb 210 disposed at the middle portion of the posterior She Ce of the transcatheter valve stent, and the number and the position are preferably set to conform to the native valve She Tezheng; wherein, the best setting mode is: the barbs 210 are arranged in succession in respective cells arranged in the same circumferential direction of the barb connection sections to maximize the anchoring effect.

Furthermore, preferably, the radial plane at the distal-most end of the inflow stent section 110 is the annulus plane, and the axial spacing between the proximal end of the barb 210 and the annulus plane is 0.5mm-5mm, further preferably 1mm-3mm; the proximal ends of the barbs 210 extend radially outwardly from the body stent segment 120 a radial length of 1mm to 8mm, and more preferably 2mm to 5mm.

In this embodiment, to further prevent the valve stent from moving from the ventricle into the atrium after implantation, it is preferable that the anchoring structure further includes barbs 220; the distal ends of the barbs 220 are connected to the body stent section 120, and the proximal ends of the barbs 220 extend radially outwardly along the body stent section 120. When the anchoring structure includes both barbs 210 and 220, the barbs 220 and barbs 210 are radially compressed within the outer tube 41 simultaneously when assembled; pushing the front end of the delivery device from the ventricle to the atrium, allowing the proximal constraint to pass through the annulus and enter the atrium, and allowing the proximal end of barb 210 to reside in the ventricle, at which time, as shown in fig. 15 and 16, outer tube 41 is withdrawn, barb 210 and barb 220 are released, and barb 210 and barb 220 are expanded; finally, as shown in fig. 17 and 18, the distal end constraint of the outflow stent segment 130 is released, the outflow stent segment 130 is released into the ventricle, the transcatheter valve stent fully resumes its original configuration, the barbs 220 penetrate the native leaflets, and the entire delivery device is withdrawn from the patient. Further increasing anchoring stability; in addition, when the barb 210 is singly arranged, the barb 220 can be prevented from losing the anchoring function from the ventricle to the atrium when the valve stent is released, and the barb 220 and the atrium supplement each other under the impact force of blood flow, specifically, the barb 220 can not be completely penetrated into the valve leaflet and fastened at the moment when the catheter valve stent is released by the conveyor, the valve stent can be pushed to the atrium by the jumping generated by the impact of blood flow or the release of the valve stent, at the moment, the barb 210 props against the valve annulus to effectively prevent the valve stent from falling into the atrium completely, the main anchoring function is realized, the barb 220 is penetrated into the valve She Yuefa stably along with the increase of time, the number of anchor points is increased, the anchoring function of the barb 210 is shared to a certain extent, the impact force born by each anchor point is reduced, the tissue damage caused by overlarge stress of the local point is avoided, and the barb 210 and the barb 220 supplement each other.

The use of the barbs 220 for anchoring native leaflets or heart tissue may further increase the anchoring capability of the transcatheter valve, and in particular, the structure of the transcatheter valve stent provided in this embodiment may further increase the anchoring capability of the transcatheter valve stent because the particular arrangement of the barbs 210 increases the anchoring effect of the valve stent without increasing the overall delivery diameter of the transcatheter valve stent after increasing the anchoring mechanism of the barbs 220, and the cooperation of the barbs 210 and the barbs 220 in this structure fuses the different anchoring mechanisms and greatly increases the anchoring capability of the transcatheter valve stent.

For the structure of the barb 220 in this embodiment, it is preferable that the barb 220 is provided with two layers along the axial direction, and the included angle between the barb 220 and the axial direction is 10 ° -60 °, and more preferably 20 ° -50 °, under this angle, which is more favorable for the barb 220 to penetrate into the native valve leaflet and maintain the excellent anchoring effect after penetrating, and the angle is not too large as to expand outwards, and scratch the tissue of the patient.

In this embodiment, the inflow stent section 110 includes a plurality of specific positioning structures, such as, but not limited to, a distal section of the inflow stent section 110 having an outer diameter that is gradually reduced from the proximal end to the distal end as shown in fig. 1-9, which are larger than the outer diameter of the main body stent section 120.

With continued reference to fig. 1-9, it is further preferred that the proximal end of the inflow stent section 110 has an inwardly turned corolla-like configuration.

In some alternative but non-limiting configurations of this embodiment, the body stent segment 120 comprises a proximal segment, a middle segment and a distal segment that are interconnected, and the outer diameter of the proximal segment of the body stent segment 120 increases gradually from proximal to distal, the outer diameter of the distal segment of the body stent segment 120 decreases gradually from proximal to distal, while avoiding the sliding of the transcatheter valve stent from the ventricle into the atrium, and the limited support force provided by the drum-shaped portion formed by the increasing outer diameter of the proximal segment of the body stent segment 120 from proximal to distal, may reduce the upward force of the barbs 210 to reduce damage to the patient's annulus and native leaflets, which may further increase the anchoring performance of the transcatheter valve stent, with the largest diameter portion of the middle segment further preventing movement of the transcatheter valve stent from the ventricle into the atrium. Preferably, as shown in fig. 19, the axial length of the middle section of the front blade side of the main body support section 120 is L1, and the axial length of the middle section of the rear She Ce of the main body support section 120 is L2, and then 0.ltoreq.l1 < L2. So that the middle section of the main body support section 120 and the rear She Ce is relatively longer, the sealing is ensured, and the middle section of the front blade side is shorter and quickly contracted, thereby achieving the effect of avoiding LVOT blocking.

To further avoid LVOT blockage, it is preferable that the angle between the outer peripheral surface of the front blade side of the inflow support section 110 and the horizontal is A1, and the angle between the outer peripheral surface of the rear blade side of the inflow support section 110 and the horizontal is A2: a1 > A2.

In this embodiment, the radial cross-sectional outer profile of the inflow stent section 110 is preferably D-shaped with a flatter section being the front She Ce and an arcuate section being the rear She Ce; the radial cross-section outer profile of the outflow stent section 130 is designed to be circular so that the inflow stent section 110 and the main body stent section 120 are more closely attached to the native annulus anatomy, which is more advantageous for the transcatheter valve stent to attach to the native annulus, reducing paravalvular leakage to a maximum extent, reducing the blockage of the left ventricular outflow orifice, avoiding LVOT blockage, and due to the more regular shape and smaller size, the valve She Naijiu performance and hydrodynamic properties are better to further alleviate the problem of poor valve durability in the prior art.

In this embodiment, in order to better constrain the distal end of the transcatheter valve stent within the outer tube 41, a delivery fixing jaw 140 is preferably provided at the distal end of the outflow stent section 130 of the transcatheter valve stent, so that the distal stent constraining member 44 and the delivery fixing jaw 140 can be releasably connected to perform corresponding constraint, and when the transcatheter valve stent is used as the outer stent to be matched with the stent-graft 300, a connecting hole may be provided at the connection between the delivery fixing jaw 140 and the distal end of the outflow stent section 130, so that the distal end of the stent-graft 300 is riveted to the distal end of the outflow stent section 130, and of course, the distal end of the stent-graft 300 and the distal end of the outflow stent section 130 may be connected together by a sewing connection or the like.

Further, in the present embodiment, it is preferable but not limited to: the inflow stent segment 110 has a hardness less than the main stent segment 120 and less than the outflow stent segment 130 to maintain good apposition and hemodynamics, and the particular arrangement may be such that the transcatheter valve stent is made by cutting tubing and the hardness is controlled by controlling the width of the cutting beams of each segment.

To further prevent paravalvular leakage, in this embodiment, preferably, the outer peripheral surface of the main body support section 120 is further connected with a peripheral sealing skirt 152 (different from the sealing skirt 153 for connection with the artificial leaflet), and the peripheral sealing skirt 152 is located inside the barbs 210 and 220; the peripheral sealing skirt 152 is designed to further reduce the passage of blood flow through the gap between the annulus and the outer peripheral surface of the body mount segment 120, further preventing paravalvular leakage, and preferably the peripheral sealing skirt 152 is a fluffy skirt.

Finally, it should be noted that:

1. in the present specification, "and/or" means "and/or" preceding structure is provided simultaneously or alternatively with "and/or" following structure;

2. in the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described by differences from other embodiments, and identical and similar parts between the embodiments are only required to be seen with each other; the above embodiments in the present specification are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.

Claims

1. A transcatheter valve stent, characterized by: comprises a grid cylindrical bracket body (100) and an anchoring structure;

the grid cylindrical stent body (100) comprises an inflow stent section (110), a main stent section (120) and an outflow stent section (130); the proximal end of the outflow stent segment (130) is connected to the distal end of the main body stent segment (120); the distal end of the inflow stent section (110) is connected to the proximal end or a location near the proximal end of the main body stent section (120); the inflow stent section (110) comprises a spacing section having an outer diameter greater than the outer diameter of the main body stent section (120) everywhere; the peripheral surface of the inflow bracket section (110) is connected with an inflow section sealing skirt (151); the circumference of the main body support section (120) is connected with a sealing skirt (153);

the anchoring structure comprises barbs (210) along the axial direction of the mesh cylindrical stent body (100): the barb (210) is in a closed ring shape, the distal end of the barb (210) is connected with the main body support section (120) or the outflow support section (130), and the proximal end of the barb (210) extends to the main body support section (120) and extends outwards along the radial direction of the main body support section (120).

2. The transcatheter valve stent of claim 1, wherein: taking one of the main body support section (120) and the outflow support section (130) connected with the barb (210) as a barb connection section; wherein:

The relative positions of the barbs (210) and the barb connection sections satisfy: under the radial shrinkage state of the grid cylindrical support body (100), each barb (210) is respectively located in different cell hollow areas in the circumferential direction of the barb connecting section.

3. The transcatheter valve stent of claim 2, wherein: the barb (210) and the grid cylindrical support body (100) are formed by cutting the same pipe fitting by laser; in the radially contracted state of the mesh cylindrical stent body (100):

the axial height of the cell hollowed-out area of the barb (210) is larger than the axial height of the cell hollowed-out area of other areas of the grid cylindrical support body (100).

4. A transcatheter valve stent as claimed in claim 3, wherein: in the grid cylindrical support body, at least the main support section (120) and the outflow support section (130) are grid supports with diamond-shaped unit grids; wherein for each cell where the barb (210) is located:

two inclined support beams which are combined into a V shape at the most distal unit lattice of the outflow support section (130) and two inclined support beams which are combined into an inverted V shape at the near end of any unit lattice of the main support section (120) are butted in the same axial direction, and the butted diamond-shaped middle area is left to be empty; the distal ends of the barbs (210) are connected between two diagonal bracing beams combined into a "V" shape of the distal-most cell of the outflow bracing segment (130).

5. The transcatheter valve stent of claim 1, wherein: taking one of the main body support section (120) and the outflow support section (130) connected with the barb (210) as a barb connection section; wherein:

the distal end of each barb (210) is connected with a support beam of the barb connection section through a transition beam (2101);

and/or, the barbs (210) are arranged in a continuous way and are arranged on each cell in the same circumferential direction of the barb connection section;

and/or the barb (210) is in a radially everted configuration relative to the barb connection section; and the included angle between the distal end section of the barb (210) and the axial direction of the grid cylindrical support body (100) is B1, and the included angle between the proximal end section of the barb (210) and the central axis of the barb connecting section is B2, then: b1 > B2 is more than or equal to 0.

6. The transcatheter valve stent of claim 1, wherein: taking a radial plane at the most distal end of the inflow stent section (110) as an annular plane, wherein an axial distance between a proximal end of the barb (210) and the annular plane is 0.5mm-5mm; the proximal ends of the barbs (210) extend radially outwardly from the body stent segment (120) a radial length of 1mm to 8mm.

7. The transcatheter valve stent of claim 1, wherein: the proximal end of the barb (210) is rounded.

8. The transcatheter valve stent of claim 1, wherein: the anchoring structure further includes barbs (220);

the distal end of the barb (220) is connected to the body stent section (120), and the proximal end of the barb (220) extends radially outwardly along the body stent section (120).

9. The transcatheter valve stent of claim 8, wherein: the barb (220) is provided with two layers along the axial direction, and the included angle between the barb (220) and the axial direction is 10-60 degrees.

10. The transcatheter valve stent of claim 1, wherein: the outer diameter of the distal section of the inflow stent section (110) gradually decreases from the proximal end toward the distal end.

11. The transcatheter valve stent of claim 1, wherein:

the main body support section (120) comprises a proximal end section, a middle section and a distal end section which are connected with each other, the outer diameter of the proximal end section of the main body support section (120) gradually increases from the proximal end to the distal end, the outer diameter of the distal end section of the main body support section (120) gradually decreases from the proximal end to the distal end, the axial length of the middle section on the front blade side of the main body support section (120) is L1, the axial length of the middle section of the rear She Ce of the main body support section (120) is L2, and then L1 is more than or equal to 0 and less than L2;

And/or, with the included angle between the front leaf side outer peripheral surface of the inflow support section (110) and the horizontal being A1, and with the included angle between the rear She Ce outer peripheral surface of the inflow support section (110) and the horizontal being A2, then: a1 > A2.

12. The transcatheter valve stent of claim 1, wherein: the radial section of the inflow bracket section (110) has a D-shaped outer profile, the straighter section is a front She Ce, and the arc section is a rear She Ce; the radial cross-section outer profile of the outflow stent section (130) is circular;

and/or, the distal end of the outflow bracket section (130) is provided with a conveying fixed claw (140).

13. The transcatheter valve stent of claim 1, wherein: the hardness of the inflow stent section (110) is less than the hardness of the main body stent section (120) is less than the hardness of the outflow stent section (130).

14. The transcatheter valve stent of claim 1, wherein:

an artificial valve leaf is connected to the inner side of the sealing skirt (153);

or, an inner stent (300) with a covering film is connected inside the outflow stent section (130), an artificial valve blade is connected inside the covering film of the inner stent (300), and the covering film of the inner stent (300) with the inflow section sealing skirt (151) or the sealing skirt (153) on the peripheral surface of the main stent section (120) is connected.

15. The transcatheter valve stent of claim 1, wherein: the inflow section sealing skirt (151) is arranged on the outer peripheral surface of the inflow bracket section (110); and/or, a peripheral sealing skirt (152) is also connected to the peripheral surface of the main body support section (120), and the peripheral sealing skirt (152) is positioned on the inner side of the anchoring structure.