CN113558825B

CN113558825B - An interventional valve stent and valve

Info

Publication number: CN113558825B
Application number: CN202110842126.3A
Authority: CN
Inventors: 王建安; 刘先宝; 扶志彬; 于大伟
Original assignee: Hangzhou Xinchang Medical Instrument Co ltd
Current assignee: Hangzhou Xinchang Medical Instrument Co ltd; Zhejiang University ZJU
Priority date: 2021-07-26
Filing date: 2021-07-26
Publication date: 2025-04-15
Anticipated expiration: 2041-07-26
Also published as: CN113558825A

Abstract

The application relates to an interventional valve support and a valve, the valve support comprises a body part, the body part is provided with a plurality of flap openings, the flap openings are provided with side walls, at least one first supporting part is arranged in at least part of the flap openings, and the first supporting part is connected with the side walls. According to the application, the first supporting part is arranged in the orifice of the valve support, so that the supporting performance of the valve support can be improved, and after the valve is placed in a patient, the supporting force of the valve support and a diseased valve of the patient can be improved, so that the risk that the valve falls off from the diseased valve is reduced, the position accuracy of the valve is improved, the working performance of the valve is improved, and the safety of the patient is ensured.

Description

Interventional valve support and valve

Technical Field

The application relates to the technical field of medical equipment, in particular to an interventional valve support and a valve.

Background

Traditional heart valve replacement surgery is an open, high-invasive procedure, is traumatic to the procedure and requires extracorporeal circulation, is at high risk, and is prone to adverse effects such as massive hemorrhage, infection, arrhythmia, etc. during the procedure, resulting in patients taking even several months to recover. Although the aortic valve replacement through the apex of the heart approach has small operation wound, the heart of the patient is still wounded, and long-time pain is brought in the recovery process. In recent years, researchers have focused on performing prosthetic heart valve replacement without opening the chest cavity or placing the patient in extracorporeal circulation in an effort to minimize trauma, the biological valve being capable of being deployed across the patient's own valve, thereby avoiding excision of the patient's diseased valve.

Because the biological valve is supported on the self valve of the patient, the risk of falling off exists when the support force of the valve support in the biological valve is insufficient or the support force of the valve support in the biological valve is not fixed, and the life safety of the patient is affected.

Disclosure of Invention

The application provides an interventional valve support and a valve, wherein the valve support has good supporting and fixing performances and can prevent the valve from falling off.

The first aspect provides an interventional valve stent comprising a body portion provided with a plurality of petals having side walls;

At least one first supporting part is arranged in at least part of the flap openings, and the first supporting part is connected with the side wall.

In one possible design, the first support divides the orifice into at least one quadrilateral configuration.

In one possible design, the first support comprises at least a first section and a second section that are bent relatively;

Along the first direction, the first section is connected with one end of the second section, and the other ends of the first section and the second section are respectively connected with the corresponding side walls.

In one possible design, the first section, the second section, and the sidewall are the same length such that the first section, the second section, and the sidewall enclose a diamond or square.

In one possible design, at least two first supporting portions are disposed in the flap opening along the second direction, and a preset distance is provided between adjacent first supporting portions.

In one possible design, at least part of the first support can be convex towards the outside of the orifice, or at least part of the first support can be concave towards the outside of the orifice.

In one possible design, the orifice is hexagonal in shape.

In one possible design, the material of the valve stent comprises cobalt-based alloy, stainless steel, or nickel titanium.

In a second aspect, the application provides a valve comprising:

a valve stent, which is the interventional valve stent;

And the valve leaflet is mounted on the valve bracket.

In one possible design, the valve is a balloon expandable valve.

According to the application, the first supporting part is arranged in the orifice of the valve support, so that the supporting performance of the valve support can be improved, the supporting force of the valve support and a lesion valve of a patient can be improved after the valve is placed in the patient, and the anchoring capacity of the valve in an interventional operation is improved, so that the risk that the valve falls off from the lesion valve is reduced, the position accuracy of the valve is improved, the working performance of the valve is improved, and the safety of the patient is ensured.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application as claimed.

Drawings

FIG. 1 is a schematic view of a valve according to a first embodiment of the present application;

FIG. 2 is a schematic view of a valve according to another embodiment of the present application;

FIG. 3 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in a first embodiment;

FIG. 4 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in a second embodiment;

FIG. 5 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in a third embodiment;

FIG. 6 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in a fourth embodiment;

FIG. 7 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in a fifth embodiment;

FIG. 8 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in a sixth embodiment;

FIG. 9 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in a seventh embodiment;

FIG. 10 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in an eighth embodiment;

FIG. 11 is a schematic view of a portion of the valve stent of FIG. 1;

FIG. 12 is a schematic view of the valve stent of FIG. 2;

FIG. 13 is a schematic view of a portion of the valve stent of FIGS. 1 and 2 in a ninth embodiment;

Fig. 14 is a top view of the leaflet of fig. 1 and 2.

Reference numerals:

1-a valve stent;

11-a body portion;

111-a first mounting port;

112-a second mounting port;

12-flap opening;

121-sidewalls;

13-a first support;

131-first stage;

132-a second section;

14-a second support;

2-leaflet;

21-a first leaflet;

22-a second leaflet;

23-third leaflet;

3-skirt edge;

X-a first direction;

Y-second direction.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the application and together with the description, serve to explain the principles of the application.

Detailed Description

For a better understanding of the technical solution of the present application, the following detailed description of the embodiments of the present application refers to the accompanying drawings.

It should be understood that the described embodiments are merely some, but not all, embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

The terminology used in the embodiments of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

It should be understood that the term "and/or" as used herein is merely an association relationship describing the associated object, and means that there may be three relationships, e.g., a and/or B, and that there may be three cases where a exists alone, while a and B exist together, and B exists alone. In addition, the character "/" herein generally indicates that the front and rear associated objects are an "or" relationship.

It should be noted that, the terms "upper", "lower", "left", "right", and the like in the embodiments of the present application are described in terms of the angles shown in the drawings, and should not be construed as limiting the embodiments of the present application. In the context of this document, it will also be understood that when an element is referred to as being "on" or "under" another element, it can be directly on the other element or be indirectly on the other element through intervening elements.

The embodiment of the application provides a valve and a valve support 1 thereof, as shown in fig. 1 and 2, the valve comprises the valve support 1, valve leaflets 2 and a skirt 3, wherein the valve leaflets 2 and the skirt 3 are arranged on the valve support 1, the valve leaflets 2 are positioned in a space formed by the valve support 1, the valve support 1 can be in a grid structure, and the skirt can seal grids of the valve support 1 through different designs and sewing, so that blood can be prevented from flowing back from a primary valve gap when blood in a heart flows back. Wherein, the material of the skirt 3 can be PET, PTFE or biological tissue material.

The expansion mode of the valve can comprise a balloon expansion mode and a self-expansion mode, wherein the balloon expansion mode is used for placing a balloon in the transcatheter aortic valve, the valve is expanded by pressurization after being input into a body through a conveying system, and then the valve is driven to expand and anchor at a lesion position, the self-expansion mode is used for realizing expansion through the inherent characteristics of the transcatheter aortic valve stent material, when the valve is placed into a human body, the transcatheter aortic valve is radially compressed and placed in a conveying system catheter, and after the valve is placed into the human body, the catheter is retracted, so that the valve can be self-expanded to the original size without restraint, and then the valve is anchored at the lesion position. Thus, the valve that expands in the manner of a balloon is a balloon-expanded valve and the valve that expands in the manner of a self-expanding valve is a self-expanding valve.

After the valve is put into a human body, taking the view angles shown in fig. 1 and 2 as an example, blood flows from top to bottom, and under the pressure of the blood, the valve leaves 2 are opened to open the blood channel of the valve, at the moment, the valve is in an open state, when the pressure of the blood is eliminated, the valve leaves 2 can be deformed and closed to block the blood channel of the valve, so that the blood is prevented from flowing backwards, and at the moment, the valve is in a closed state. Meanwhile, after the valve is placed into a human body, the valve can be usually supported at a lesion valve of the human body, so that the lesion valve is replaced to work. Therefore, it is necessary to ensure the position of the valve after the valve is placed in the human body, that is, the valve needs to be placed in the human body and then to be detached.

In the embodiment of the present application, as shown in fig. 3 to 10, the valve support 1 includes a body portion 11, the body portion 11 is provided with a plurality of openings 12, the openings 12 have side walls 121, at least a portion of the openings 12 are provided with at least one first supporting portion 13, and the first supporting portion 13 is connected with the side walls 121.

In this embodiment, by arranging the first supporting portion 13 in the orifice 12 of the valve support 1, the first supporting portion 13 can improve the supporting performance of the valve support 1 along the first direction X (radial direction), and after the valve is placed in the patient, the supporting force of the valve support 1 and the diseased valve of the patient can be improved, so that the risk that the valve falls off from the diseased valve is reduced, the position accuracy of the valve is improved, the working performance of the valve is improved, and the safety of the patient is ensured.

In addition, as shown in fig. 8-10, in the working process of the valve, under the pressure of blood, the first supporting portion 13 can be deformed, for example, the first supporting portion 13 can protrude towards the outer side of the valve support 1 or can be recessed towards the inner side of the valve support 1, so that the riveting effect of the valve and the native valve annulus is improved, and the risk of valve falling is further reduced.

Specifically, as shown in fig. 3 to 7, the first supporting portion 13 separates the orifice 12 into at least one quadrilateral structure.

As described above, the valve needs to be expanded after being placed in the patient, that is, the valve needs to be deformed, so that the valve stent 1 needs to have good deformability, and since the quadrangular structure has the characteristic of being easily deformed when being stressed, when the first supporting portion 13 partitions the orifice 12 into the quadrangular structure, the valve stent 1 has high supporting force and good deformability, thereby improving the performance of the valve.

In one embodiment, as shown in fig. 3 to 7, the first supporting portion 13 at least includes a first section 131 and a second section 132 that are bent relatively, and one end of the first section 131 and one end of the second section 132 are connected along the first direction X, and the other end of the first section and the other end of the second section are respectively connected with the corresponding side wall 121.

In this embodiment, after the first and second sections 131 and 132 that are bent relatively are connected with the two side walls 121 of the orifice 12, a quadrilateral structure is enclosed, at this time, the first and second sections 131 and 132 can improve the supporting performance of the valve support 1, that is, when the valve support 1 is subjected to an external force along the first direction X, the first and second sections 131 and 132 can play a supporting role, and at the same time, when the valve support 1 is expanded, the first and second sections 131 and 132 that are bent relatively can deform at the connecting position of the two sections, thereby facilitating the expansion of the valve support 1.

The included angle between the first segment 131 and the second segment 132 may be any angle between 0 ° and 180 °, as long as the two are not located on the same straight line.

More specifically, as shown in fig. 3 to 7, the lengths of the first segment 131, the second segment 132 and the sidewall 121 are the same, so that the first segment 131, the second segment 132 and the sidewall 121 enclose a diamond or square shape.

In this embodiment, when the first segment 131, the second segment 132 and the side wall 121 enclose a diamond or square, the diamond or square structure has higher stability of deformation under the action of external force, and the diamond or square structure has the advantage of convenient processing, and improves the appearance performance of the valve support 1.

In the embodiment shown in fig. 3, after the first support portion 13 is provided, the first support portion 13 separates the orifice 12 into a quadrilateral and a hexagonal structure, both of which are deformable during expansion of the valve holder 1.

In another embodiment, as shown in fig. 6 and 7, at least two first supporting portions 13 are disposed in the orifice 12 along the second direction Y, and a predetermined distance is provided between adjacent first supporting portions 13. The preset distance may be set according to practical situations, as long as the two first supporting portions 13 do not interfere with each other in the process of pressing the valve support 1, that is, the two first supporting portions 13 have a gap along the second direction Y in the process of pressing the valve support 1, or the two first supporting portions 13 just contact with each other along the second direction Y, so as to prevent the two first supporting portions 13 from mutually pressing and affecting the expansion of the valve support 1.

In this embodiment, when at least two first supporting portions 13 are disposed in the orifice 12, the orifice 12 can be divided into at least two quadrangles, and the at least two quadrangles can further promote expansion of the valve stent 1 when the valve stent 1 is expanded.

Wherein, the two first supporting parts 13 may include a first segment 131 and a second segment 132 which are bent relatively, and the first segment 131 and the second segment 132 are connected with the side wall 121 of the orifice 12. In the embodiment shown in fig. 6 and 7, two first support portions 13 are provided in the orifice 12 in the second direction Y, so as to divide the orifice 12 into two quadrangular and one hexagonal structures.

In the above embodiments, the shape of the orifice 12 may be hexagonal. Specifically, the shape of the orifice 12 may be regular hexagonal, i.e., the length of each sidewall 121 of the orifice 12 is equal.

In this embodiment, when the hexagonal orifice 12 receives an external force, the deformation amounts of the various parts are similar, so that the valve support 1 can expand uniformly, the performance of the valve in the patient is improved, and meanwhile, the structure of the valve support 1 can be simplified, and the appearance performance of the valve is improved.

On the other hand, the material of the valve holder 1 comprises cobalt chrome alloy.

Meanwhile, the first support portion 13 is provided at the flap port 12 corresponding to the skirt 3.

One end of a skirt 3 of the traditional valve is fixedly connected with a valve leaflet 2, the other end of the skirt is fixedly connected with the bottom end of a valve bracket 1, the valve is compressed in a catheter, and when the percutaneous interventional heart valve is replaced, the skirt is expanded at a required position through balloon expansion, so that the original valve is replaced. However, the primary valve is either asynchronous in opening and closing of the valve leaflet 2, serious in reflux, serious in calcification of the valve leaflet 2 and incomplete in opening and closing, and in either case, after the percutaneous implanted valve is implanted, the stent 1 is more easily attached to the surrounding annulus and is not tight, so that blood flows into the ventricle from the gap at the edge of the valve, perivalvular leakage is caused, and when the perivalvular leakage is serious, chest distress, shortness of breath, hemolysis, anemia, angina and other complications occur after a patient is operated.

In order to solve this technical problem, as shown in fig. 1 and 2, after the skirt 3 is mounted on the valve holder 1, the area of the skirt 3 is greater than or equal to the area of the valve holder 1 so that the skirt 3 can freely move. Therefore, after the valve is placed into a human body, the skirt edge 3 can move freely, so that gaps between the valve and the peripheral annulus can be filled under the pressure of blood, the valve is tightly attached to the peripheral annulus after being placed into the human body, blood is prevented from flowing into a ventricle from the edge of the valve, the occurrence of paravalvular leakage is reduced, and finally the aim of treatment is achieved.

More specifically, as shown in fig. 1 and 2, the skirt 3 is closed along the circumference of the valve holder 1. After the percutaneous implantation of the valve, the closed skirt 3 is tightly attached to the annulus of the primary valve, so that the inflow of blood from the gap of the valve support 1 into the heart chamber of a patient can be reduced, the paravalvular leakage of the valve is reduced, the occurrence of chest distress, short breath, hemolysis, anemia, angina and other complications of the patient after the valve replacement operation is reduced, and the safety of the valve is improved.

In a specific embodiment, the skirt 3 comprises a top end and a bottom end along the height of the valve holder 1, and the top end and the bottom end are mounted to the valve holder 1, e.g. the top end and the bottom end are sewn to the valve holder 1. Meanwhile, between the top and bottom ends, the area of the skirt 3 is greater than or equal to the area of the valve holder 1, and the skirt 3 near the top end and the skirt 3 near the bottom end are connected to form a ring-shaped structure or a pleated structure.

In this embodiment, when the area of the skirt edge 3 between the top end and the bottom end is larger than the area of the valve support 1, a gap is formed between the skirt edge 3 between the top end and the bottom end and the valve support 1, so that the gap between the valve and the peripheral annulus can be filled under the pressure of blood, the valve is tightly attached to the peripheral annulus after being placed into a human body, the blood is prevented from flowing into the ventricle from the edge of the valve, and the occurrence of paravalvular leakage is reduced. At the same time, when the skirt 3 near the top end and the skirt 3 near the bottom end are joined, it is helpful to form a ring-shaped structure or a wrinkle structure on the skirt 3.

When the top end and the bottom end of the skirt 3 are sewn on the valve support 1 during valve processing, the area of the skirt 3 between the top end and the bottom end is larger than or equal to the area of the valve support 1, so that the skirt 3 can pinch an annular structure or a fold structure by itself, and then a needle thread is sewn between the top end and the bottom end from bottom to top or from top to bottom, thereby forming the annular structure or the fold structure.

In another embodiment, as shown in fig. 11, the valve holder 1 includes a plurality of first mounting openings 111, the skirt 3 is mounted on the first mounting openings 111 and seals the first mounting openings 111, and the plurality of first mounting openings 111 are located at the same height along the second direction Y, so that the skirt 3 has the annular structure shown in fig. 1.

In yet another embodiment, as shown in fig. 12, the plurality of first mounting openings 111 are located at different heights along the second direction Y, so that the skirt 3 is in a pleated structure.

In the above two embodiments, the structure enclosed by the skirt 3 is determined according to the position of each first mounting opening 111, that is, when each first mounting opening 111 is located at the same height, the skirt 3 forms an annular sewing ring, when the heights of each first mounting opening 111 are different, the skirt 3 forms an irregularly shaped sewing ring, and whichever can be tightly attached to the surrounding annulus after implantation, so that blood is prevented from flowing into the ventricle from the valve edge, the occurrence of paravalvular leakage is reduced, and finally the therapeutic purpose is achieved.

In addition, the skirt 3 is sewn to the valve holder 1 at the first mounting opening 111, so that the valve does not need to provide a support frame for the skirt 3, but the skirt 3 is sewn directly to the valve holder 1, thereby simplifying the structure of the valve.

In each of the above embodiments, as shown in fig. 1 and 2, the skirt 3 has a single-layer structure, and a part of the skirt 3 is located inside the valve holder 1 and another part protrudes outside the valve holder 1 through the first mounting opening 111.

In this embodiment, when the skirt 3 is sewn to the valve holder 1, the skirt 3 with a single layer structure may be placed in the valve holder 1, and then a part of the skirt 3 extends out of the valve holder 1 through the first mounting opening 111 and is sewn at the first mounting opening 111, so that both the inner side and the outer side of the valve holder 1 have the skirt 3, thereby further reducing the occurrence of paravalvular leakage and improving the performance of the valve. In addition, when the skirt 3 positioned on the inner side and the outer side of the valve bracket 1 is of an integrated structure, the sewing difficulty of the skirt 3 can be simplified, and the strength and the reliability of the skirt can be improved.

On the other hand, as shown in fig. 3, the valve holder 1 includes a second mounting port 112, and the second mounting port 112 is arranged in the second direction Y with the first mounting port 111, and the leaflet 2 is mounted to the second mounting port 112 and blocks the second mounting port 112. The valve support 1 has three second mounting openings 112 as shown in fig. 3, and the valve includes three valve leaflets 2, where the three second mounting openings 112 are all used for mounting the valve leaflets 2 (the valve leaflets 2 can be mounted on the second mounting openings 112 by sewing or bonding), and the included angle between the three second mounting openings 112 is 120 °, as shown in fig. 14, so that the first valve leaflets 21, the second valve leaflets 22 and the third valve leaflets 23 are symmetrically distributed, and the first valve leaflets 21, the second valve leaflets 22 and the third valve leaflets 23 are the same in size.

As shown in fig. 13, a second support portion 14 is provided at the second mounting port 112, the second support portion 14 for supporting the leaflet 2 in the first direction X.

In this embodiment, when the valve is pressed and held before being placed in the patient, the valve support 1 of the valve is deformed by the pressing and holding force, and by providing the second supporting portion 14, after the valve support 1 is deformed and contracted, the second supporting portion 14 can support the valve leaflet 2, so as to prevent the valve leaflet 2 from being crushed by the valve support 1, and improve the safety and reliability of the valve.

Wherein, as shown in fig. 13, the second support portion 14 may extend in a first direction X so as to be able to radially support the leaflet 2 during crimping of the valve.

The valve in the embodiment of the application is a balloon expansion valve.

As described above, the expansion modes of the valve include a self-expanding type and a balloon expanding type, and for the self-expanding valve, since the height of the valve stent 1 is large, when the self-expanding valve is used again for a replacement operation of "valve-in-valve" for a patient who has already adopted the self-expanding valve in the future, the newly implanted self-expanding valve has a risk of blocking the coronary artery inlet, while the valve stent 1 Gao Duyuan of the balloon expanding valve is much smaller than the height of the valve stent of the self-expanding valve, and the coronary artery inlet is not blocked at all when the replacement operation of "valve-in-valve" is performed again later. Thus, the safety of the balloon expandable valve is higher.

In addition, the valve in the embodiment of the application is a balloon expansion valve, so that when the skirt 3 is sewn on the valve bracket 1, compared with a self-expansion valve, the circumferential closing structure of the skirt 3 can be realized without a traction rope, thereby simplifying the structure of the valve.

The above is only a preferred embodiment of the present application, and is not intended to limit the present application, but various modifications and variations can be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. An interventional valve stent, characterized in that the valve stent (1) comprises a main body (11), the main body (11) is provided with a plurality of valve openings (12), and the valve openings (12) have side walls (121);

Wherein, along the second direction (Y), at least part of the valve opening (12) is provided with at least two first support portions (13), the first support portions (13) being connected to the side wall (121), and the at least two first support portions (13) being capable of dividing the valve opening (12) into at least two quadrilaterals;

The valve support (1) comprises a second mounting opening (112), wherein a second supporting portion (14) is provided at the second mounting opening (112), wherein the leaflets (2) of the valve can be mounted on the second mounting opening (112) and seal the second mounting opening (112), wherein the second supporting portion (14) extends along a first direction (X), and is used to support the leaflets (2) in a radial direction when the valve is pressed and gripped.

2. The invasive valve stent according to claim 1, characterized in that the first support portion (13) comprises at least a first section (131) and a second section (132) that are bent relative to each other;

Along a first direction (X), one end of the first section (131) is connected to the second section (132), and the other ends of the two are respectively connected to the corresponding side wall (121).

3. The interventional valve stent according to claim 2, characterized in that the first section (131), the second section (132) and the side wall (121) are of the same length so that the first section (131), the second section (132) and the side wall (121) form a rhombus or a square.

4. The interventional valve stent according to claim 2, characterized in that there is a preset distance between adjacent first supporting portions (13).

5. The interventional valve stent according to any one of claims 1 to 4, characterized in that at least a portion of the first support portion (13) can bulge outward toward the outside of the valve orifice (12), or at least a portion of the first support portion (13) can be concave toward the outside of the valve orifice (12).

6. The invasive valve stent according to any one of claims 1 to 4, characterized in that the shape of the valve opening (12) is hexagonal.

7. The invasive valve stent according to any one of claims 1 to 4, characterized in that the material of the valve stent (1) comprises cobalt-based alloy, stainless steel or nickel titanium.

8. A valve, characterized in that the valve comprises:

A valve stent (1), wherein the valve stent (1) is the interventional valve stent (1) according to any one of claims 1 to 7;

A valve leaflet (2), wherein the valve leaflet (2) is mounted on the valve support (1).

9. The valve according to claim 8 is characterized in that the valve is a balloon-expandable valve.