CN113558825A

CN113558825A - Novel intervention type valve support and valve

Info

Publication number: CN113558825A
Application number: CN202110842126.3A
Authority: CN
Inventors: 扶志彬; 于大伟; 侯文博; 王建安; 刘先宝
Original assignee: Hangzhou Xinchang Medical Instrument Co ltd
Current assignee: Hangzhou Xinchang Medical Instrument Co ltd
Priority date: 2021-07-26
Filing date: 2021-07-26
Publication date: 2021-10-29

Abstract

The present application relates to a novel interventional valve stent and valve, the valve stent comprising a body portion provided with a plurality of valve orifices having side walls; at least one first supporting part is arranged in at least part of the valve opening, and the first supporting part is connected with the side wall. In this application, through set up first supporting part in valve support's valve mouth, this first supporting part can improve valve support's support performance, and after valve was put into the patient internally, can improve valve support and patient's pathological change valve's holding power to reduce the risk that this valve drops from pathological change valve, improve the position precision of valve, thereby improve the working property of valve, and ensure patient's safety.

Description

Novel intervention type valve support and valve

Technical Field

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

Background

Traditional heart valve replacement surgery is an open high-invasive procedure, has large surgical trauma and needs extracorporeal circulation, has high surgical risk, and is easy to have adverse reactions such as heavy bleeding, infection, arrhythmia and the like during the surgery, so that patients can recover even in months. Aortic valve replacement via apical approach still causes trauma to the heart of a patient although the surgical wound is small, and brings long-time pain in the recovery process. In recent years, researchers have been working on achieving prosthetic heart valve replacement without opening the chest or placing the patient in extracorporeal circulation, in an effort to minimize trauma, and the biological valve can be placed across the patient's own valve to avoid cutting the patient's diseased valve.

Because the biological valve is supported on the self-valve of the patient, the supporting force of the valve support in the biological valve is insufficient or the biological valve is not fixed properly, so that the risk of falling off exists, and the life safety of the patient is influenced.

Disclosure of Invention

The application provides a novel intervention formula valve support and valve, and this valve support's support nature and fixity can be better, can prevent that the valve from droing.

The present first aspect provides a novel interventional valve stent comprising a body portion provided with a plurality of valve orifices having side walls;

at least one first supporting part is arranged in at least part of the valve opening, 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 supporting part at least comprises a first section and a second section which are bent oppositely;

along a 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 a possible design, along the second direction, at least two first supporting portions are arranged in the valve orifice, and a preset distance is reserved between the adjacent first supporting portions.

In one possible design, at least part of the first support portion may be convex towards the outside of the orifice, or at least part of the first support portion may 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 includes a cobalt-based alloy, stainless steel, or nickel titanium.

A second aspect of the present application provides a valve comprising:

the valve stent is the novel interventional valve stent;

a leaflet mounted to the valve support.

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

In this application, through set up first supporting part in valve support's valve mouth, this first supporting part can improve valve support's support performance, and after valve was put into the patient internally, can improve valve support and patient's pathological change valve's holding power, improve the anchoring ability of valve in intervening in the operation simultaneously to reduce the risk that this valve drops from pathological change valve, improve the position precision of valve, thereby improve the working property of valve, and ensure patient's safety.

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.

Drawings

FIG. 1 is a schematic structural view of a valve provided herein in a first embodiment;

FIG. 2 is a schematic structural view of a valve provided herein in another embodiment;

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

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

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

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

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

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

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

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

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

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

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

figure 14 is a top view of the leaflet of figures 1 and 2.

Reference numerals:

1-a valve stent;

11-a body portion;

111-a first mounting port;

112-a second mounting port;

12-orifice of the valve;

121-sidewalls;

13-a first support;

131-a first section;

132-a second segment;

14-a second support;

2-valve leaflets;

21-a first leaflet;

22-a second leaflet;

23-a 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 present application and together with the description, serve to explain the principles of the application.

Detailed Description

For better understanding of the technical solutions of the present application, the following detailed descriptions of the embodiments of the present application are provided with reference to the accompanying drawings.

It should be understood that the embodiments described are only a few embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

The terminology used in the embodiments of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in the examples of 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 one type of association that describes an associated object, meaning that three relationships may exist, e.g., a and/or B may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

It should be noted that the terms "upper", "lower", "left", "right", and the like used 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 addition, in this context, it will also be understood that when an element is referred to as being "on" or "under" another element, it can be directly on "or" under "the other element or be indirectly on" or "under" the other element via an intermediate element.

The embodiment of the application provides a valve and a valve support 1 thereof, as shown in fig. 1 and 2, the valve comprises a valve support 1, a valve leaflet 2 and a skirt 3, wherein the valve leaflet 2 and the skirt 3 are both mounted on the valve support 1, and the valve leaflet 2 is positioned in a space formed by the valve support 1; the valve support 1 can be of a grid structure, the skirt edge seals the grid of the valve support 1 through different designs and sewing, and blood can be prevented from flowing back from the gaps of the native valve when the blood of the heart flows back. Wherein, the material of the skirt 3 can be PET, PTFE, 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 that a balloon is placed in a transcatheter aortic valve, and the valve is pressurized to expand the balloon after being delivered into a body through a delivery system so as to drive the valve to expand and be anchored at a lesion position; the self-expanding expansion mode realizes expansion through inherent characteristics of a transcatheter aortic valve stent material, when the stent is placed into a human body, the transcatheter aortic valve is radially compressed and placed in a catheter of a delivery system, and after the stent is placed into the human body, the catheter is withdrawn, so that the valve can be self-expanded to the original size under the unconstrained condition so as to be anchored at a diseased position. Thus, a valve that is balloon-expanded in an expansion manner is a balloon-expanded valve, and a valve that is self-expanding in an expansion manner is a self-expanding valve.

After the valve is placed in a human body, taking the view shown in fig. 1 and 2 as an example, blood flows from top to bottom, and under the pressure of the blood, the valve leaf 2 is opened, so that the blood passage of the valve is opened, and at this time, the valve is in an open state; when the pressure of the blood disappears, the valve leaf 2 can be deformed and closed, thereby blocking the blood channel of the valve and preventing the blood from flowing backwards, and at the moment, the valve is in a closed state. Meanwhile, the valve can be supported at the diseased valve of the human body after being placed in the human body, so that the valve can work instead of the diseased valve. Therefore, the valve needs to be ensured to be in the position after being placed in the human body, namely, the valve needs to be placed and then falls off after being placed in the human body.

In the embodiment of the present application, as shown in fig. 3 to 10, the valve stent 1 includes a body portion 11, the body portion 11 is provided with a plurality of orifices 12, the orifices 12 have a side wall 121, wherein at least one first supporting portion 13 is disposed in at least part of the orifices 12, and the first supporting portion 13 is connected to the side wall 121.

In this embodiment, through set up first supporting part 13 in the valve mouth 12 at valve support 1, this first supporting part 13 can improve valve support 1 along the support performance of first direction X (radial), and after the valve was put into the patient, can improve the holding power of valve support 1 and patient's pathological change valve to reduce the risk that this valve drops from pathological change valve, improve the position precision of valve, thereby improve the working property of valve, and ensure patient's safety.

In addition, as shown in fig. 8 to 10, in the present embodiment, during the operation of the valve, under the pressure of blood, the first supporting portion 13 can be deformed, for example, the first supporting portion 13 can be protruded toward the outer side of the valve stent 1, or can be recessed toward the inner side of the valve stent 1, so as to improve the effect of riveting the valve and the native valve annulus, and further reduce the risk of the valve falling off.

Specifically, as shown in fig. 3 to 7, the first support part 13 divides the orifice 12 into at least one quadrangular structure.

As described above, the valve needs to be expanded after being placed in the body of the patient, that is, the valve needs to be deformed, so that the valve stent 1 needs to have good deformability, and since the quadrilateral structure has a characteristic of being easily deformed when being stressed, when the first supporting portion 13 partitions the valve orifice 12 into the quadrilateral 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 segment 131 and a second segment 132 bent oppositely; along the first direction X, the first segment 131 is connected to one end of the second segment 132, and the other ends of the two are respectively connected to the corresponding sidewalls 121.

In this embodiment, after the first section 131 and the second section 132 bent relatively are connected with the two sidewalls 121 of the orifice 12, a quadrilateral structure is enclosed, and at this time, the first section 131 and the second section 132 can improve the support performance of the valve stent 1, that is, when the valve stent 1 is subjected to an external force along the first direction X, the first section 131 and the second section 132 can play a role in supporting; meanwhile, when the valve stent 1 is expanded, the first segment 131 and the second segment 132, which are bent relatively, can be deformed at the position where they are connected, thereby facilitating the expansion of the valve stent 1.

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

More specifically, as shown in FIGS. 3-7, the first segment 131, the second segment 132, and the sidewall 121 are the same length such 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 section 131, the second section 132 and the sidewall 121 form a diamond or a square, the diamond or the square has a high deformation stability under an external force, and the diamond or the square has an advantage of convenient processing and improves the appearance of the valve stent 1.

In the embodiment shown in fig. 3, after the first support part 13 is provided, the first support part 13 divides the orifice 12 into a quadrangular structure and a hexagonal structure, both of which are deformable during expansion of the valve stent 1.

In another specific 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 preset distance is provided between adjacent first supporting portions 13. Wherein, this preset distance can set up according to actual conditions, as long as make valve support 1 not interfered by two first supporting parts 13 of the in-process of pressing and holding, two first supporting parts 13 of the in-process of pressing and holding of valve support 1 promptly have the clearance along second direction Y, perhaps, two first supporting parts 13 just contact along second direction Y to prevent that two first supporting parts 13 from extrudeing each other and influencing the inflation of valve support 1.

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

The two first supporting portions 13 may each include a first section 131 and a second section 132 bent oppositely, and the first section 131 and the second section 132 are connected to the sidewall 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, thereby dividing the orifice 12 into two quadrangular and one hexagonal configurations.

In each of the above embodiments, the orifice 12 may be hexagonal in shape. Specifically, the shape of the orifice 12 may be a regular hexagon, i.e., the length of each side wall 121 of the orifice 12 is equal.

In this embodiment, when the hexagonal orifice 12 is subjected to an external force, the deformation amounts of the various parts are close to each other, so that the valve stent 1 can be expanded uniformly, the performance of the valve in the body of a patient is improved, and meanwhile, the structure of the valve stent 1 can be simplified, and the appearance performance of the valve is improved.

On the other hand, the material of the valve stent 1 includes cobalt-chromium alloy.

Meanwhile, the first support part 13 is provided at the orifice 12 corresponding to the skirt 3.

One end of a skirt 3 of the traditional valve is fixedly connected with the valve leaflet 2, the other end of the skirt is fixedly connected with the bottom end of the valve support 1, the valve is compressed in a catheter, and when the valve is replaced by a percutaneous intervention heart valve, the valve is expanded at a required position through balloon expansion, so that a native valve is replaced. But native valve or leaflet 2 opens and shuts asynchronously, causes the palirrhea serious, or leaflet 2 calcification is serious, and the opening and shutting is incomplete, either kind of situation, after percutaneous implanted valve is implanted, support 1 all can laminate inseparably with surrounding ring face more easily to make blood flow into the ventricle from valve edge gap, cause the perivalvular leakage, when the perivalvular leakage is serious, lead to patient postoperative complications such as chest distress, short breath, hemolysis, anemia, angina pectoris.

In order to solve the technical problem, as shown in fig. 1 and 2, after the skirt 3 is installed on the valve support 1, the area of the skirt 3 is larger than or equal to that of the valve support 1, so that the skirt 3 can move freely. 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 surrounding ring surface can be filled under the pressure of blood, the valve is tightly attached to the surrounding ring surface after being placed into the human body, the blood is prevented from flowing into a ventricle from the edge of the valve, the perivalvular leakage is reduced, and the purpose of treatment is finally 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 valve is implanted percutaneously, the closed skirt 3 is attached to the ring surface of the native valve more tightly, so that blood can be reduced from flowing into the heart chamber of a patient from the gap of the valve support 1, the perivalvular leakage of the valve is reduced, the occurrence of complications of the patient such as chest distress, shortness of breath, hemolysis, anemia and angina pectoris after valve replacement is reduced, and the safety of the valve is improved.

In one embodiment, the skirt 3 includes 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, for example, the top end and the bottom end are sewn to the valve holder 1. Meanwhile, the area of the skirt 3 between the top end and the bottom end is larger than or equal to that of the valve support 1, and the skirt 3 close to the top end is connected with the skirt 3 close to the bottom end to form a ring structure or a fold structure.

In this embodiment, when the area of the skirt 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 3 between the top end and the bottom end and the valve support 1, and the gap can move freely, so that the gap between the valve and the surrounding annulus can be filled under the pressure of blood, the valve is tightly attached to the surrounding annulus after being placed into a human body, blood is prevented from flowing into a ventricle from the edge of the valve, and the occurrence of perivalvular 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 loop or a corrugated structure on the skirt 3.

When the valve is processed, when the top end and the bottom end of the skirt edge 3 are sewn on the valve support 1, the area of the skirt edge 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 edge 3 can be pinched out to form an annular structure or a folded structure by itself, and then the skirt edge is sewn between the top end and the bottom end from bottom to top or from top to bottom by using needle threads, thereby forming the annular structure or the folded structure.

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

In the 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 suture ring, and when the heights of the first mounting openings 111 are different, the skirt 3 forms an irregularly-shaped suture ring, so that any one of the two can be tightly attached to the surrounding annulus after implantation, thereby preventing blood from flowing into the ventricle from the edge of the valve, reducing the occurrence of perivalvular leakage, and finally achieving the purpose of treatment.

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

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

In this embodiment, when the skirt 3 is sewn on the valve stent 1, the skirt 3 of a single-layer structure may be placed in the valve stent 1, and then a portion of the skirt 3 extends out of the valve stent 1 through the first mounting hole 111 and is sewn at the first mounting hole 111, so that the skirt 3 is provided on both the inner side and the outer side of the valve stent 1, thereby further reducing the occurrence of perivalvular leakage and improving the performance of the valve. In addition, when the skirt 3 positioned at the inner side and the outer side of the valve support 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 opening 112, and the second mounting opening 112 and the first mounting opening 111 are arranged in the second direction Y, and the leaflet 2 is mounted to the second mounting opening 112 and blocks the second mounting opening 112. As shown in fig. 3, the valve holder 1 has three second mounting openings 112, and the valve includes three leaflets 2, the three second mounting openings 112 are all used for mounting the leaflets 2 (the leaflets 2 can be mounted to 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 leaflet 21, the second leaflet 22 and the third leaflet 23 are symmetrically distributed, and the first leaflet 21, the second leaflet 22 and the third leaflet 23 are the same in size.

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

In this embodiment, when the valve is crimped before being placed in a patient, the valve stent 1 of the valve is deformed by the crimping force, and by providing the second support portion 14, after the valve stent 1 is deformed and contracted, the second support portion 14 can support the valve leaflet 2, so that the valve leaflet 2 is prevented from being crushed by the valve stent 1, and the safety and reliability of the valve are improved.

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

The valve described in the embodiments of the present application is a balloon-expandable valve.

As described above, the valve expansion modes include self-expansion and balloon expansion, for the self-expansion valve, because of the large height of the valve support 1, when the self-expansion valve is used again for the replacement operation of the valve in the future for the patient who already adopts the self-expansion valve, the newly-implanted self-expansion valve risks blocking the coronary artery entrance, while the height of the valve support 1 of the balloon expansion valve is far smaller than that of the valve support of the self-expansion valve, and when the replacement operation of the valve in the valve is carried out again subsequently, the coronary artery entrance is not blocked at all. Thus, balloon-expandable valves are safer.

In addition, the valve in the embodiment of the application is a balloon-expandable valve, so that when the skirt 3 is sewn on the valve support 1, compared with a self-expandable valve, the peripheral sealing structure of the skirt 3 can be realized without a traction rope, and the structure of the valve is simplified.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A new type of interventional valve stent, characterized in that the valve stent (1) comprises a body portion (11), the body portion (11) being provided with a plurality of orifices (12), the orifices (12) having side walls (121);

at least one first supporting part (13) is arranged in at least part of the valve opening (12), and the first supporting part (13) is connected with the side wall (121).

2. The new interventional valve stent of claim 1, characterized in that the first support part (13) divides the orifice (12) into at least one quadrilateral structure.

3. The new type of interventional valve stent according to claim 2, characterized in that the first support part (13) comprises at least a first section (131) and a second section (132) that are relatively bent;

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

4. The novel interventional valve stent of claim 3, wherein the first section (131), the second section (132) and the sidewall (121) are the same length such that the first section (131), the second section (132) and the sidewall (121) enclose a diamond or square shape.

5. The new type of interventional valve stent according to claim 2, characterized in that in the second direction (Y) at least two first supports (13) are provided within the orifice (12) with a predetermined distance between adjacent first supports (13).

6. The novel interventional valve stent of any one of claims 1-5, characterized in that at least part of the first support (13) is outwardly convex towards the outside of the orifice (12) or at least part of the first support (13) is inwardly concave towards the outside of the orifice (12).

7. The novel interventional valve stent of any one of claims 1-5, wherein the valve orifice (12) is hexagonal in shape.

8. A novel interventional valve stent according to any one of claims 1-5, characterized in that the material of the valve stent (1) comprises cobalt-based alloy, stainless steel or nickel titanium.

9. A valve, comprising:

a valve stent (1), wherein the valve stent (1) is a novel interventional valve stent (1) according to any one of claims 1-8;

a leaflet (2), the leaflet (2) being mounted to the valve holder (1).

10. The valve of claim 9, wherein the valve is a balloon-expandable valve.