CN215875097U

CN215875097U - Valve stent applied to aortic valve regurgitation

Info

Publication number: CN215875097U
Application number: CN202120488250.XU
Authority: CN
Inventors: 潘文志; 周达新; 葛均波
Original assignee: Shanghai Hanyu Medical Technology Co ltd
Current assignee: Shanghai Hanyu Medical Technology Co ltd
Priority date: 2021-03-08
Filing date: 2021-03-08
Publication date: 2022-02-22
Anticipated expiration: 2031-03-08

Abstract

The utility model relates to a valve stent applied to aortic valve regurgitation, belonging to the technical field of medical instruments. Comprises a main body bracket, a fixing piece, a bridging bracket, a skirt edge, an artificial valve leaflet and a connecting piece; the bridging bracket is connected to the lower end of the main body bracket, and the connecting piece is connected to the lower end of the bridging bracket; the main body support is provided with a fixing part at one end close to the aorta, and the main body support is provided with an artificial valve leaflet and a skirt edge. The utility model overcomes the defects of the prior art and provides the valve stent for treating aortic regurgitation, which can be firmly fixed at the aortic valve annulus and can realize transfemoral implantation and release.

Description

Valve stent applied to aortic valve regurgitation

Technical Field

The utility model relates to a valve stent applied to aortic valve regurgitation, belonging to the technical field of medical instruments.

Background

Transcatheter Aortic Valve Replacement (TAVR) is performed by compressing a stent with a biologic valve outside the body into a catheter, and then delivering the valve stent along the peripheral vessel or apex to the aortic root for release and fixation at the native aortic annulus to replace the native aortic valve. Currently, transcatheter aortic valve replacement has become the first line treatment for elderly patients, especially those with surgically high risk aortic stenosis. For patients with aortic valve regurgitation, TAVR is not currently recommended internationally as a treatment for this. Different from a patient with aortic stenosis, the autologous aortic valve of the aortic regurgitation patient has no calcified hard mass, so the valve stent commonly used in clinic at present is easy to slide and cannot be well fixed due to the straight cylinder structure.

Aiming at the situation that the aortic valve regurgitation valve is easy to slide, J-valve (Chinese patent numbers CN110013357A, CN 210697902U) adds 3U-shaped valve anchors at the periphery on the basis of a valve support, and plays a role in assisting valve fixation to prevent the valve from sliding. However, such a design of J-valve makes the valve stent bulky, the delivery system is up to 27F, and it can only be implanted transapically. Jena Valve (Chinese patent No. CN 103002833B) adopts a similar design, three reinforcing parts are added on a valve stent to play a role in assisting and fixing, and the design can only be implanted through the apex of the heart. The Chinese patent No. CN 20451236U, CN105662652A adds a W-shaped outer ring fixing ring on the basis of the valve stent, but still can not solve the difficult problem of realizing transfemoral implantation.

Chinese patent nos. CN103108611B (Accurate Neo) and CN105476731A designed a valve capable of transfemoral release that also contained an auxiliary anchoring element, but the anchoring element was small and oriented towards the aortic arch (not inserted into the aortic sinus), and the anchoring element was poorly fixed, and was not suitable for patients with aortic valve regurgitation, but only for patients with aortic stenosis. Chinese patent No. CN105496606A provides a valve stent, which comprises a support frame and three circular connecting claws. The design of the valve stent can only adopt a method of respectively releasing the upper (aortic valve side) and lower (left ventricular outflow tract), and in the actual release process, because the valve stent on the aortic valve side is not completely released in the process, three circular connecting claws are not fully opened and cannot be supported to the bottom of an aortic sinus, the valve stent is difficult to be positioned to the accurate position, and the release through the femoral artery is difficult to realize in the actual application. Chinese patent No. CN11329621A provides a transcatheter prosthetic valve, a delivery system, i.e., a delivery method, which is theoretically a prosthetic aortic valve that can be released via the femoral artery. However, in actual research, development and processing, the valve stent at the outflow end of the stent has insufficient length and cannot suture biological valves, and the inflow end of the stent is too long and not closed, so that the outflow tract of the left ventricle and the mitral valve of a human body are pressed, and complications such as conduction block, mitral valve injury and the like are generated. Therefore, in summary, the TAVR valves for treating aortic regurgitation in the prior art have the problems of difficult fixation at the native valve annulus, only transapical implantation, low maneuverability of transfemoral implantation, etc.

Disclosure of Invention

The utility model aims to solve the technical problems that in the prior art, a TAVR valve for treating aortic regurgitation is difficult to fix at a native valve annulus, can be implanted only through an apex of the heart and has low operability in implantation through a femoral artery. In the utility model, the upward direction refers to the direction pointing to one end of the aorta when the valve stent is implanted at the aortic valve position, and the downward direction refers to the opposite direction pointing to the outflow tract of the left ventricle; the proximal end refers to the end close to the operator, and the distal end refers to the end far away from the operator.

In order to solve the problems, the technical scheme adopted by the utility model is to provide a valve support applied to aortic valve regurgitation, which comprises a main body support, a fixing piece, a bridging support, a skirt edge, an artificial valve leaflet and a connecting piece, wherein the main body support is provided with a plurality of fixing pieces; the bridging bracket is connected to the lower end of the main body bracket, and the connecting piece is connected to the lower end of the bridging bracket; the main body support is provided with a fixing part at one end close to the aorta, and the main body support is provided with an artificial valve leaflet and a skirt edge.

Preferably, cavity channels which are communicated with the ventricle and the aorta are arranged among the main body bracket, the bridging bracket and the connecting piece.

Preferably, the main body support is a straight cylindrical grid-shaped support.

Preferably, one end of the fixing member is provided with a round and blunt free end extending towards the ventricle for inserting into the bottom of the aortic sinus, and the other end of the fixing member is connected to the outer side of the main body support.

Preferably, the number of the fixing pieces is set to 2 or more.

Preferably, a bridging bracket is arranged at one end of the main body bracket close to the ventricle, and the bridging bracket is of a grid-shaped bracket structure with a lower end cone shape and gathered towards the central shaft of the main body bracket.

Preferably, one end of the bridging bracket close to the ventricle is provided with a connecting piece for movably connecting the valve bracket with the delivery system.

Preferably, the outer side of the main body bracket is provided with a skirt for preventing the leakage around the valve; the main body bracket is provided with an artificial valve leaflet.

Preferably, the main body bracket, the fixing piece and the bridging bracket are made of memory alloy; the main body bracket and the fixing piece which are arranged in the catheter of the delivery system are set to be in a non-overlapping state.

Preferably, the artificial valve leaflet is a valve prosthesis which is sewn on the main body support and is used for opening or closing a cavity channel, and the artificial valve leaflet is made of biological tissues or high molecular materials.

Preferably, the skirt is made of a biocompatible polymer material.

Compared with the prior art, the utility model has the following beneficial effects:

the aortic valve stent comprises a large fixing part, can be firmly fixed at the aortic sinus, is not easy to displace and can treat aortic regurgitation;

the unique design and release mode of the bridging bracket can realize the implantation and release through femoral artery;

the bridging bracket is folded towards the center, so that the left ventricular outflow tract and the mitral valve cannot be pressed at the left ventricular outflow tract, and related complications cannot be generated;

the main body bracket, the fixing piece and the bridging bracket are integrally formed, the structure is firm, the processing is relatively simple, the main body bracket, the fixing piece and the bridging bracket are not mutually overlapped in the axial direction, a small sheath tube can be retracted, and conditions are provided for transfemoral femoral artery implantation.

Drawings

Fig. 1 is a schematic structural diagram of a valve stent applied to aortic regurgitation in accordance with the present invention.

Fig. 2 is a top view of a valve stent for aortic regurgitation according to the present invention.

Fig. 3 is a schematic diagram of the valve stent for aortic regurgitation in vitro release according to the present invention.

The states during the release process are illustrated by (a) - (d) in the figure.

Fig. 4 is a schematic view of the in vivo release of a valve stent for aortic regurgitation according to the present invention.

Reference numerals: 1. a main body support; 2. a fixing member; 3. a bridging scaffold; 4. a skirt edge; 5. artificial valve leaflets; 6. a connecting member.

Detailed Description

In order to make the utility model more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:

as shown in fig. 1, the present invention provides a valve stent for aortic regurgitation, comprising a main body stent 1, a holder 2, a bridging stent 3, a skirt 4, an artificial leaflet 5 and a connecting piece 6; the main body bracket 1 is connected with a connecting piece 6 through a bridging bracket 3; the bridging bracket 3 is connected with the lower end of the main body bracket 1, and the connecting piece 6 is arranged at the lower end of the bridging bracket 1; the main body support 1 is provided with a fixing part 2 at one end close to the aorta, and the main body support 1 is provided with an artificial valve leaflet 5 and a skirt edge 4. And cavity channels which are communicated with the ventricle and the aorta and are communicated with each other are arranged among the main body bracket 1, the bridging bracket 3 and the connecting piece 6. One end of the fixing member 2 is a blunt free end extending towards the ventricle for inserting into the bottom of the aortic sinus, and the other end of the fixing member 2 is connected to the outer side of the main body support 1. The number of the fixing pieces 2 is set to 2 or more. One end of the main body support 1 close to the ventricle is provided with a bridging support 3, and the bridging support 3 is of a grid support structure with a conical lower end folded towards the central shaft of the main body support 1. One end of the bridging bracket 3 close to the ventricle is provided with a connecting piece 6 for movably connecting the valve bracket with the delivery system. The outer side of the main body bracket 1 is provided with a skirt edge 4 for preventing the valve from leaking; the main body bracket 1 is provided with an artificial valve leaflet 5 at one side close to the aorta. The main body bracket 1, the fixing piece 6 and the bridging bracket 3 are made of memory alloy. The artificial valve leaflet 5 is a valve prosthesis that is sutured to the main body stent 1 and opens or closes a lumen channel, and is made of a biological tissue (e.g., bovine pericardium, porcine pericardium, etc.) or a polymer material. The skirt edge 4 is made of a high polymer material with biocompatibility.

Examples

To overcome the deficiencies of the prior art, the present invention provides a valve stent for treating aortic regurgitation that is both securely fixed at the aortic valve annulus and is implanted and released trans-femoral, as shown in fig. 1. Comprises a main body bracket 1, a fixing piece 2, a bridging bracket 3, a skirt edge 4, an artificial valve leaf 5 and a connecting piece 6.

The main body support 1 of the valve support is a cylindrical or approximately cylindrical structure and is a support formed by a plurality of rhombic grid unit grids. The stent is a short stent, the length of the stent is shorter than that of the prior self-expansion in the prior art, and the length of the stent is 10-30mm, so that the risk of main coronary artery occlusion is reduced, and a channel is reserved for subsequent coronary artery intervention.

One end of the fixing piece 2 is a round and blunt free tail end, and the other end is connected to the aorta side of the main body bracket 1; and the round free tail end is a structure extending downwards and outwards, the whole body is in a shape of an arc, a lug, a triangle or an ellipse, and the number of the round free tail ends is 3. The fixing part 2 can be inserted into the bottom of the aortic sinus after being released from the delivery sheath, and plays a role in fixing the whole valve stent.

The bridging support 3 is connected with the lower end of the main body support 1, is of a latticed support structure with the lower end folded towards the center, and is provided with a connecting piece 6 at the lower end, so that the connection with a conveying system can be realized. The traditional valve stent implanted through the femoral artery is connected with a conveying system through a connecting piece positioned on the aorta side (the upper end of the stent), and the valve stent is released from bottom to top when released in the operation; the present invention is connected to the delivery system by a connector 6 (at the lower end of the valve stent) at the left ventricular outflow tract bridge, and the valve stent is released from top to bottom during the surgical operation (see fig. 3). Because the main body support 1 is shorter, the bridging support 3 is equivalent to the extension of the length of the main body support 1 in the axial direction, so that the main body support 1 can be expanded into an intermediate form, namely a conical form (the short support can only be in a strip shape when being released from the sheath and then directly jumps to a completely released barrel shape) in the process of releasing the sheath, and the fixing piece 2 at the upper end of the main body support 1 can be fully unfolded and can be inserted into the bottom of the aortic sinus instead of slipping from the center of the annulus of a human body. Meanwhile, the lower end of the bridging bracket 3 is folded towards the center, so that the left ventricular outflow tract and the mitral valve of a human body cannot be pressed at the left ventricular outflow tract, and related complications cannot be generated.

The main body support 1, the fixing piece 2 and the bridging support 3 are made of memory alloy and are formed by integrally cutting a nickel-titanium tube through laser. Has shape memory and self-expanding properties; the delivery catheter can be compressed in vitro and expanded in vivo to return to the working state. The main body bracket 1 and the fixing piece 2 are made into a final working state by cutting the same nickel-titanium tube into hollow grids through laser, and then carrying out heat setting to make the hollow grids expand and deform. When the main body support 1 and the fixing piece 2 are compressed to the conveying conduit, the main body support and the fixing piece are in a state of being carved on a nickel titanium pipe during heat setting, and the cross section of the main body support and the fixing piece is not overlapped, so that the main body support and the fixing piece can be compressed to enter a small conveying sheath pipe.

The connecting member 6 is a structure of a protrusion connected to the lower end of the bridging bracket 3, and is a releasable connection for the delivery system. The connecting element 6 is arranged in a circular, oval or ear-like configuration. The central part of the connecting piece 6 may be hollowed out.

The artificial valve leaflet 5 is an artificial valve sewn in the cavity of the main body bracket 1, is a three-leaflet valve and is made of bovine pericardium, porcine pericardium or high polymer materials.

The skirt 4 is made of a biocompatible polymer material and covers the periphery of the main body support 1 to prevent the leakage around the valve.

The implantation and release process of the valve stent of the utility model is as follows (as shown in figure 4): firstly, pressing a valve stent into a strip shape outside the body, filling the strip shape into a conveying sheath tube, and conveying the strip shape into the root of an aorta through a femoral artery; wherein, the valve bracket is wholly surrounded on the central rod of the delivery system, the connecting piece 6 which is protruded at the lower end of the bridging bracket 3 is fixed on the connecting structure of the central rod of the delivery sheath, and the whole valve bracket is positioned in the capsule cavity at the far end of the delivery sheath (as a picture in fig. 4); secondly, pushing the capsule cavity at the far end of the delivery sheath tube to the far end, exposing the aortic end of the valve stent out of the capsule cavity and releasing the aortic end of the valve stent, and expanding the upper end of the main stent 1 and the fixing piece 2 first (as shown in a b figure in fig. 4); push the whole delivery sheath towards the left ventricle, so that the fixing member 2 moves towards and is fixed in the aortic sinus (as shown in c in fig. 4); fourthly, the capsule cavity at the far end of the conveying sheath tube is continuously pushed to the far end, so that the bridging bracket 3 is released, and the bridging bracket 3 is expanded; the connecting structure of the connecting piece 6 and the central rod of the conveying sheath is released, and finally the whole valve stent is released (as shown in a d picture in figure 4), and the stent is fixed at the active valve ring of the human body.

While the utility model has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the utility model. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims

1. A valve support applied to aortic valve regurgitation is characterized in that: comprises a main body bracket, a fixing piece, a bridging bracket, a skirt edge, an artificial valve leaflet and a connecting piece; the bridging bracket is connected to the lower end of the main body bracket, and the connecting piece is connected to the lower end of the bridging bracket; the main body support is provided with a fixing part at one end close to the aorta, and the main body support is provided with an artificial valve leaflet and a skirt edge.

2. The valve stent applied to aortic valve regurgitation of claim 1 wherein: and cavity channels which are communicated with the ventricle and the aorta are arranged among the main body bracket, the bridging bracket and the connecting piece.

3. The valve stent applied to aortic valve regurgitation of claim 1 wherein: the main body support is a straight cylindrical latticed support.

4. The valve stent applied to aortic valve regurgitation of claim 1 wherein: one end of the fixing piece is a round and blunt free end which extends towards the ventricle and is used for being inserted into the bottom of the aortic sinus, and the other end of the fixing piece is connected to the outer side of the main body support.

5. The valve stent applied to aortic valve regurgitation of claim 4 wherein: the number of the fixing pieces is set to be greater than or equal to 2.

6. The valve stent applied to aortic valve regurgitation of claim 1 wherein: one end of the main body support, which is close to the ventricle, is provided with a bridging support which is of a latticed support structure with a lower end cone shape and is folded towards the central shaft of the main body support.

7. The valve stent for aortic valve regurgitation as claimed in claim 6 wherein: and one end of the bridging bracket, which is close to the ventricle, is provided with a connecting piece for movably connecting the valve bracket and the delivery system.

8. The valve stent applied to aortic valve regurgitation of claim 1 wherein: the outer side of the main body bracket is provided with a skirt edge for preventing the valve from leaking around; the main body bracket is provided with an artificial valve leaflet.

9. The valve stent applied to aortic valve regurgitation of claim 1 wherein: the main body bracket, the fixing piece and the bridging bracket are made of memory alloy; the main body bracket and the fixing piece which are arranged in the catheter of the delivery system are set to be in a non-overlapping state.

10. The valve stent applied to aortic valve regurgitation of claim 1 wherein: the artificial valve leaflet is a artificial valve which is sewn on the main body support and used for opening or closing a cavity channel, and is made of biological tissues or high polymer materials.

11. The valve stent applied to aortic valve regurgitation of claim 1 wherein: the skirt is made of a high polymer material with biocompatibility.