阅读说明：本技术 一种支架瓣膜 (Stent valve ) 是由 阮成民 肖建平 林育坤 曾杰 姜小飞 于 2021-10-08 设计创作，主要内容包括：本发明涉及医疗器械领域,具体而言,涉及一种支架瓣膜。支架瓣膜包括瓣膜本体和瓣膜支架；瓣膜支架包括密封段、引流段、过渡段、装配段和操控段；密封段、引流段、过渡段、装配段和操控段依次连接；瓣膜本体设置在装配段的内部。本发明通过密封段、引流段、过渡段和装配段的设置,将瓣膜本体进行固定,通过操控段对整体进行操控,提高了操控的便捷性,进而能够在较小的创伤的情况下,减少了操作的失误,最终达到减少并发症发生的目的。(The invention relates to the field of medical equipment, in particular to a stent valve. The stent-valve comprises a valve body and a valve stent; the valve stent comprises a sealing section, a drainage section, a transition section, an assembly section and a control section; the sealing section, the drainage section, the transition section, the assembling section and the control section are sequentially connected; the valve body is disposed inside the fitting section. According to the invention, the valve body is fixed through the arrangement of the sealing section, the drainage section, the transition section and the assembling section, and the whole valve body is controlled through the control section, so that the control convenience is improved, the operation errors are reduced under the condition of smaller trauma, and the purpose of reducing the occurrence of complications is finally achieved.)

1. A stent-valve comprising a valve body and a valve stent;

the valve stent comprises a sealing section, a drainage section, a transition section, an assembly section and a control section;

the sealing section, the drainage section, the transition section, the assembly section and the control section are sequentially connected;

the valve body is disposed inside the fitting section.

2. The stent-valve of claim 1, wherein a diameter of an end of the sealing section distal to the drainage section is larger than a diameter of an end of the sealing section proximal to the drainage section.

3. The stent-valve of claim 1, wherein a diameter of an end of the transition section connecting the drainage section is larger than a diameter of an end of the transition section connecting the assembly section.

4. The stent-valve of claim 1, wherein the manipulation section comprises a plurality of overhanging ends, wherein a mesh opening formed between the overhanging ends and the mounting section is larger than a mesh opening of the mounting section.

5. The stent-valve of claim 1, wherein the skirt of the valve body is disposed in correspondence with the transition section.

6. The stent-valve of claim 1, wherein the sealing section is provided with a tab at an end thereof away from the drainage section, and the manipulation section is provided with a tab at an end thereof away from the assembly section.

7. The stent-valve of claim 1, wherein the width of the connecting rods between any two adjacent mesh nodes on the valve stent is greater at both ends than in the middle of the connecting rods.

8. The stent-valve of claim 7, wherein the width of the connecting rods varies to be continuously gradual.

9. The stent-valve of claim 7, wherein the connecting rod has a width of 0.3mm to 0.5mm at both ends and a width of 0.2mm to 0.4mm at a middle portion of the connecting rod.

10. The stent-valve of claim 1, wherein the valve body is disposed within the valve stent by sewing, heat staking, or adhesive.

Technical Field

The invention relates to the field of medical equipment, in particular to a stent valve.

Background

The tricuspid valve, the right atrioventricular valve, connects the right atrium and the right ventricle of the heart. The tricuspid valve acts as a "one-way valve" to ensure that blood circulation must flow from the right atrium to the right ventricle and through a certain amount of flow. When the right ventricle of the heart contracts, blood in the chamber is squeezed, the blood impacts the valve, the tricuspid valve is closed, and the blood does not pour into the right atrium.

The pathophysiological changes in cardiac tricuspid insufficiency are mainly manifested in two aspects: firstly, the load of the right ventricle is aggravated and the right heart function is not complete due to the reverse blood flow and the pressure caused by the tricuspid valve regurgitation, and then the right atrium and the ventricle are enlarged, the tricuspid valve annulus is enlarged, and the tricuspid valve regurgitation is further increased to form a vicious circle; the reverse blood flow and the pressure thereof cause high pressure in the right atrium and the upper and lower vena cava, blood backflow obstruction, blood stasis of important organs and cause corresponding dysfunction, such as liver, renal insufficiency, digestive dysfunction, blood coagulation dysfunction and the like, and in addition, the right heart dysfunction can also cause the reduction of right heart blood discharge and pulmonary oxygenation dysfunction; the high pressure, hypertonic condition of the right atrium can also lead to atrial fibrillation and further worsen the state of cardiac function, with severe patient survival rates of less than 70% with severe tricuspid valve reactions, and a risk of death.

The surgical operation is the most main treatment means for the tricuspid regurgitation at present, but has the defects of large trauma, more complications, high mortality rate and the like. With the progress of biomedical materials and the development of medical imaging, the transcatheter valve replacement and repair treatment makes breakthrough progress, and becomes a hotspot of interventional cardiology. Transcatheter treatment of tricuspid valve disease progresses relatively late relative to the other three heart valves, mostly in the animal experimental phase. Although animal experiments successfully completed transcatheter in situ tricuspid valve placement to treat tricuspid regurgitation, the risk of valve-bearing stent detachment was high and could not be clinically applied. Therefore, based on the limitations of the current surgical operations, it is necessary to find a tricuspid valve regurgitation treatment method which has the advantages of small trauma, simple operation and few complications.

Disclosure of Invention

The invention aims to provide a stent-valve which has less trauma, less complications and more convenient operation when in use.

The embodiment of the invention is realized by the following steps:

the invention provides a stent-valve, which comprises a valve body and a valve stent;

the valve stent comprises a sealing section, a drainage section, a transition section, an assembly section and a control section;

the sealing section, the drainage section, the transition section, the assembly section and the control section are sequentially connected;

the valve body is disposed inside the fitting section.

In an alternative embodiment, the diameter of the end of the sealing section remote from the drainage section is larger than the diameter of the end of the sealing section close to the drainage section.

In an alternative embodiment, the diameter of the end of the transition section connecting the flow-directing section is larger than the diameter of the end of the transition section connecting the fitting section.

In an alternative embodiment, the handling section comprises a plurality of overhanging ends, and the mesh formed between the overhanging ends and the fitting section is larger than the mesh of the fitting section.

In an alternative embodiment, the skirt of the valve body is disposed in correspondence with the transition section.

In an optional embodiment, the sealing section and the control section are provided with a mounting hole, and the mounting hole is provided with a mounting hole.

In an alternative embodiment, the width of the two ends of the connecting rod between any two adjacent grid nodes on the valve stent is greater than the width of the middle of the connecting rod.

In an alternative embodiment, the width of the connecting rod is varied to a continuously gradual change.

In an alternative embodiment, the width of the two ends of the connecting rod is 0.3mm-0.5mm, and the width of the middle part of the connecting rod is 0.2mm-0.4 mm.

In alternative embodiments, the valve body is disposed within the valve holder by sewing, heat staking, or adhesive.

The embodiment of the invention has the beneficial effects that:

through the setting of sealing section, drainage section, changeover portion and assembly section, fix the valve body, control the convenience of controlling through controlling the section to whole, and then can be under the condition of less wound, reduced the error of operation, finally reach the purpose that reduces the complication and take place.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.

FIG. 1 is a schematic structural view of a stent-valve provided in accordance with an embodiment of the present invention;

FIG. 2 is a top view of a stent-valve provided by an embodiment of the present invention;

FIG. 3 is a bottom view of a stent-valve provided by an embodiment of the present invention;

FIG. 4 is a schematic structural diagram of a connecting rod of a stent-valve according to an embodiment of the present invention;

fig. 5-7 are schematic views illustrating the arrangement of the hangers of the stent-valve according to the embodiment of the invention.

Icon: 1-a sealing section; 2-a drainage section; 3-a transition section; 4-assembling the sections; 5-a manipulation section; 6-hanging a lug; 7-a valve body; 8-skirt edge; 9-a valve stent; 10-a connecting rod; 11-mesh nodes.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of 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 present invention, 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 derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or the orientations or positional relationships that the products of the present invention are conventionally placed in use, and are only used for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

Furthermore, the terms "horizontal", "vertical", "overhang" and the like do not imply that the components are required to be absolutely horizontal or overhang, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly and may, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Some embodiments of the present invention are described in detail below with reference to fig. 1-4. The embodiments described below and the features of the embodiments can be combined with each other without conflict.

The invention provides a stent-valve, comprising a valve body 7 and a valve stent 9; the valve stent 9 comprises a sealing section 1, a drainage section 2, a transition section 3, an assembly section 4 and a control section 5; the sealing section 1, the drainage section 2, the transition section 3, the assembly section 4 and the control section 5 are connected in sequence; the valve body 7 is arranged inside the fitting section 4.

The stent valve can prevent blood backflow of blood vessels at any position in a body, and regulate blood pressure of blood vessels or internal organs, thereby treating and reducing the heart blood backflow of patients with atrial fibrillation.

Wherein, the valve body 7 is the main working part, and the valve body 7 is implanted into the blood vessel or replaces other native valves, so that the reverse flow of the blood at the position can be prevented without influencing the forward flow of the blood.

Wherein, the valve support 9 is the auxiliary delivery and positioning part of the valve. The valve stent 9 is a high-elasticity metal tube, such as a nickel-titanium or cobalt-chromium alloy tube, and is formed by laser cutting and shaping. The valve-stent 9 can maintain its circular cross-section when subjected to a uniform radial force to reduce its diameter, thereby allowing the valve-stent 9 to be stored in a reduced diameter manner for delivery into a small-sized delivery system.

Specifically, in the present embodiment, the valve stent 9 includes five parts, namely a sealing section 1, a drainage section 2, a transition section 3, an assembling section 4 and a manipulating section 5.

In general, the sealing section 1 is a stent edge of a blood inflow end, and the inflow end of the sealing section 1 has a larger diameter, so that the radial expansion force of the valve stent 9 at the edge can be increased, and the edge of the valve stent 9 is more tightly attached to a vessel wall, thereby preventing blood from flowing in from the outside of the valve stent 9; the drainage end is provided with a larger grid, so that the contact area of the valve stent 9 and the blood vessel can be increased, the friction force between the valve stent 9 and the blood vessel is increased, and the function of fixing the valve stent 9 is achieved; the transition section 3 is of variable diameter and is connected with the drainage section 2 and the assembly section 4; the assembly section 4 is provided with a smaller diameter to adapt to the size of the valve body 7 and has a denser grid so as to facilitate the sewing of the valve body 7; the control section 5 is composed of a larger grid, has better deformation capacity, and can enable the valve stent 9 to be more easily loaded into a conveying sheath.

In the embodiment, the stent-valve can be implanted into any blood vessel in the body, and plays a role in one-way drainage or choke flow at any position in the blood vessel.

In the present embodiment, the sealing section 1 and the transition section 3 of the valve stent 9 can prevent the stent from moving axially downward, and the control section 5 of the valve stent 9 can prevent the valve stent 9 from moving axially upward, so as to complete the axial position of the valve stent 9 in the blood vessel and prevent the valve stent 9 from moving due to blood pressure.

In this embodiment, the valve stent 9 can be made of non-super-elastic metal or polymer material and deployed in the blood vessel by means of balloon expansion.

Specifically, in the present embodiment, the valve stent 9 may be woven by using a super elastic material.

In this embodiment, the valve body 7 may be made of a polymer material with good biocompatibility.

In an alternative embodiment, the diameter of the end of the sealing section 1 remote from the drainage section 2 is larger than the diameter of the end of the sealing section 1 close to the drainage section 2.

Specifically, in this embodiment, the diameter of the sealing section 1 is increased, so that the sealing section 1 can be attached to the inner wall of the blood vessel, the sealing performance between the valve stent 9 and the blood vessel is ensured, and blood can completely pass through the valve body 7.

In an alternative embodiment, the diameter of the end of the transition section 3 connected to the flow-directing section 2 is larger than the diameter of the end of the transition section 3 connected to the mounting section 4.

In this embodiment, the diameter of the transition section 3 is changed to be gradual, so that the transition section 3 can be better attached to the inner wall of the blood vessel.

In an alternative embodiment, the handling section 5 comprises a plurality of overhanging ends, the mesh formed between the overhanging ends and the fitting section 4 being larger than the mesh of the fitting section 4.

Specifically, in this embodiment, because how the main effect of controlling section 5 is to control valve stent 9, input the support valve into the heart, be greater than the mesh of controlling section 5 with the mesh of overhanging end, can enough satisfy the user demand of controlling section 5, and increased behind the mesh, can be more convenient for control section 5, also reduced valve stent 9's material cost simultaneously.

In an alternative embodiment, the skirt 8 of the valve body 7 is arranged in correspondence with the transition section 3.

In this embodiment, the valve body 7 includes two parts, namely a valve leaflet and a skirt 8, wherein when the valve body 7 is fixed, the skirt 8 is arranged at a position corresponding to the transition section 3, so that the eversion of the skirt 8 is matched with the different diameters of the transition section 3, and the stability of the valve body 7 arranged inside the valve support 9 can be further ensured.

In this embodiment, the transition section 3 where the skirt 8 is arranged can enable the skirt 8 to be tightly attached to the vessel wall, so as to reduce the probability of valve leakage.

Specifically, in the present embodiment, the valve leaflet is disposed on the assembling section 4 of the valve support 9, and can be opened and closed according to the pressure of blood flow to prevent the blood from flowing reversely; the shirt rim 8 sets up in the changeover portion 3 and the drainage end of support, and the cladding is in valve support 9's interior circle, for sealed drainage part, and the laminating degree of multiplicable apparatus and vascular wall avoids blood to directly erode valve support 9, reduces the valve week and leaks and reduce the risk of thrombus formation.

In an alternative embodiment, the end of the sealing section 1 away from the drainage section 2 and the end of the control section 5 away from the assembly section 4 are provided with lugs 6.

Specifically, in this embodiment, the hangers 6 are disposed at both ends of the valve stent 9, so that the valve stent 9 can be implanted into any position in the blood vessel through any passage in a predetermined flow blocking direction, i.e., the valve stent 9 can be delivered from any direction of the implantation target site.

Specifically, in the present embodiment, the hanging lug 6 provided on the operation section 5 is on the extending end, and the hanging lug 6 provided on the sealing section 1 is on any connecting rod 10 thereof.

Wherein, the hangers 6 arranged on the control section 5 and the hangers 6 arranged on the middle sealing section 1 are uniformly arranged by taking the central axis of the valve support 9 as a central axis.

In this embodiment, the hanging loop 6 can be disposed in various ways, such as a ring shape, a bent shape, etc., as shown in fig. 5-7, as long as it can facilitate the connection of the valve stent.

In this embodiment, the original shape of the valve stent 9 is a circular shape as a whole, and after the valve stent 9 is implanted into a body, such as a blood vessel or a native valve, a certain shape deformation is generated according to the different implantation positions, so that the shape deformation may be changed into an oval shape or other irregular shapes in a certain section, thereby facilitating the fixation of the valve stent 9 in the blood vessel.

Therefore, the connecting rods 10 between any two adjacent grid nodes 11 on the valve stent 9 are required to have better fatigue performance, and the strain capacity of the connecting rods can be better ensured.

To achieve the above function, in an alternative embodiment, the width of the two ends of the connecting rod 10 between any two adjacent grid nodes 11 on the valve stent 9 is greater than the width of the middle of the connecting rod 10.

Specifically, in the present embodiment, each connecting rod 10 of the valve stent 9 is configured to have a wide end and a narrow middle.

More specifically, in the present embodiment, the rod width of both ends of the connecting rod 10 may be set to 0.3mm to 0.5mm, and the minimum rod width of the middle of the connecting rod 10 may be set to 0.2mm to 0.4 mm.

In the valve support 9 with the arrangement mode, in the transition from the retraction conveying system to the two states of release in the blood vessel, the deformation of each single connecting rod 10 can be uniformly distributed to each position on the rod length of the connecting rod 10, the breakage caused by overlarge strain of the valve support 9 is reduced, the maximum deformation capacity of the valve support 9 is increased, the supporting force distribution of the valve support 9 is optimized, and the fatigue performance of the valve support 9 is improved.

When the connecting rod 10 is in the same width with the valve stent 9, the maximum width of the cross section of the connecting rod is generally set to be 0.3mm-0.5mm, the stress is concentrated at the turning point after the connecting rod is expanded and deformed, the connecting rod is easy to break, and the fatigue performance is poor; fig. 4 shows the valve stent 9 with different widths at the two ends and the middle position of the connecting rod 10, the deformation quantity of the connecting rod is uniformly distributed at each position in the length direction of the connecting rod 10, the local strain quantity is small, and the design can reduce the stress of the stent deformation and increase the deformation capacity and the fatigue performance of the stent.

Specifically, in the present embodiment, the cross section of the connecting rod 10 is circular or fan-shaped, and it may be square or other shapes.

In an alternative embodiment, the width of the connecting rod 10 varies in a continuous gradual change.

Specifically, in this embodiment, the width of the connecting rod 10 changes gradually into a continuous gradual change, which changes into a curve, and can adapt to the stress distribution of the supporting force, thereby improving the fatigue performance of the valve stent 9.

In alternative embodiments, the valve body 7 is arranged in the valve holder 9 by sewing, heat-fusing or adhesive bonding.

The valve leaf and the skirt edge 8 are connected through sewing, and both can be made through cutting and sewing by using animal pericardium, and have high fatigue strength and good biocompatibility.

The valve can be attached to the inner circle of the mounting section 4 of the valve holder 9 by heat fusion or adhesive bonding.

The leaflets are joined to the skirt 8 by heat fusion or adhesive bonding or the like.

The leaflets and skirt 8 can be sewn or bonded together by laser cutting.

The embodiment of the invention has the beneficial effects that:

through the setting of sealing section 1, drainage section 2, changeover portion 3 and assembly section 4, fix valve body 7, control the convenience of controlling through controlling section 5 to whole, and then can be under the condition of less wound, reduced the error of operation, finally reach the purpose that reduces the complication and take place.

The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes will occur to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.