Prosthetic valves

Abstract

The present invention provides an artificial valve, comprising: a stent, the stent comprising a first mesh segment, a second mesh segment and a limiting segment connected to each other, the second mesh segment being located between the first mesh segment and the limiting segment, the second mesh segment forming a barrel-shaped structure, the diameter of the first mesh segment increasing from the direction close to the second mesh segment to the direction away from the second mesh segment, the limiting segment having an outward flange; a sealing film, the sealing film being arranged on the stent; and a leaflet, the leaflet being arranged on the second mesh segment so that the flow direction of the fluid is from the first mesh segment to the limiting segment. The technical solution of the present invention effectively solves the problem of circumferential positioning and fixation of the existing interventional tricuspid valve.

Description

Technical Field

[0001] The present invention relates to the technical field of artificial prosthetic devices, and in particular to an artificial valve. Background Art

[0002] The natural heart valves (aortic, pulmonary, tricuspid and mitral valves) play a very important role in ensuring the supply of blood to the body.

[0003] Artificial valves are used to treat heart valve disease. When problems occur with natural heart valves, artificial valves are used to replace natural valves. Since the tricuspid valve ring is a "D"-shaped structure and there is a coronary sinus between the inferior vena cava and the tricuspid valve orifice, accurate circumferential positioning of the artificial valve for tricuspid valve replacement is particularly important; and while ensuring accurate valve positioning, effectively avoiding the coronary sinus and firmly fixing it are also essential requirements for the tricuspid valve. Summary of the invention

[0004] The main purpose of the present invention is to provide a tricuspid valve, the distal imaging point can solve the problem of inaccurate circumferential positioning of the tricuspid valve in the prior art; the distal limiting structure indicates the release position on the one hand, and fixes the valve on the other hand. At the same time, the notch design of the valve itself can avoid blocking the coronary sinus after implantation, ensuring the normal function of the valve.

[0005] In order to achieve the above-mentioned purpose, the present invention provides an artificial valve, comprising: a stent, the stent comprising a first grid segment, a second grid segment and a limiting segment connected to each other, the second grid segment is located between the first grid segment and the limiting segment, the second grid segment forms a barrel-shaped structure, the diameter of the first grid segment increases from the direction close to the second grid segment to the direction away from the second grid segment, and the first grid segment has an avoidance gap, and the limiting segment has an outward flange; a sealing membrane, the sealing membrane is arranged on the stent; and leaflets, the leaflets are arranged on the second grid segment so that the flow direction of the fluid is from the first grid segment to the limiting segment.

[0006] Furthermore, the limiting segment is connected to the second grid segment. The limiting segment is at least one "U"-shaped structure. The middle of the limiting segment extends toward the first grid segment. Both ends of the "U"-shaped structure are respectively connected to the second grid segment.

[0007] Furthermore, the limiting segment is a plurality of “U”-shaped structures, and the plurality of “U”-shaped structures are evenly distributed at the first end of the second grid segment.

[0008] Furthermore, there are three "U"-shaped structures and three petals, and the three petals are arranged in one-to-one correspondence with the three "U"-shaped structures.

[0009] Furthermore, the first grid segment is a trumpet-shaped structure, and the first grid segment is composed of two, three or multiples of three petal-shaped support bars, and the support bars are evenly arranged in the circumferential direction.

[0010] Furthermore, the avoidance gap of the first grid segment is a fan-shaped structure.

[0011] Furthermore, the bracket also includes a plurality of connecting ears, and the plurality of connecting ears are arranged at the first end of the first grid segment.

[0012] Furthermore, the bracket is made by cutting or weaving.

[0013] Furthermore, the stent also includes a barb connected to the second mesh segment and extending in a direction away from the central axis of the second mesh segment.

[0014] Furthermore, the barbs extend obliquely toward the first mesh segment.

[0015] Furthermore, there are multiple barbs, the angle between the barbs and the outer side wall of the second grid segment is between 10 degrees and 80 degrees, and the length of the barbs is between 1 mm and 10 mm.

[0016] Furthermore, the artificial valve also includes a developing component, and the developing component is arranged on the bracket.

[0017] Furthermore, the developing component is located at the vertices of the outward flange of the limiting section (13), and the developing component on at least one vertex is different from that on other vertices, which can be used to distinguish the circumferential positioning of the valve.

[0018] Furthermore, the first grid segment is provided with a sealing film, the first grid segment has an avoidance gap, and the developing component is arranged corresponding to the avoidance gap.

[0019] Furthermore, the cross section of the second grid segment is "D"-shaped.

[0020] Furthermore, the vertices of the outward flanges of the limiting segment are respectively provided with three display locations, wherein the display locations of the vertices of the flanges corresponding to the avoidance notches of the first grid segment along the axial direction are provided with three display points for easy display of the position. As shown in the figure, the number of display points of the three display locations is different.

[0021] By applying the technical solution of the present invention, the artificial valve is transported to a position beyond the target position in the right ventricle through a conveying device. The limiting segment is first released. According to the developing point of the vertex of the limiting segment, the conveyor is rotated as a whole to adjust the circumferential direction of the artificial valve so that the "D"-shaped structure of the valve after release can correspond to the "D"-shaped valve ring of the tricuspid valve. The artificial valve is withdrawn, and the flange of the limiting segment will contact the distal end of the natural leaflet or the tendon to form a blocking limit. Then the conveying device releases the second mesh segment, and the diameter of the second mesh segment increases and is stuck in the tricuspid valve ring. Finally, the first mesh segment is released, and the diameter of the first mesh segment increases from the direction close to the second mesh segment to the direction away from the second mesh segment, so that the first mesh segment will form a limit in another direction to prevent the valve from falling into the right ventricle. The above structure makes the fixing effect of the artificial valve at the tricuspid valve better. The technical solution of the present invention effectively solves the problems of adaptability and circumferential positioning of the artificial valve and human organs. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0023] Figure 1 A schematic front view of an embodiment of an artificial valve according to the present invention is shown;

[0024] Figure 2 Shows Figure 1 A schematic top view of an artificial valve;

[0025] Figure 3 A schematic top view of an artificial valve according to another embodiment of the artificial valve of the present invention is shown;

[0026] Figure 4 Shows Figure 1 A schematic front view of a stent for an artificial valve; and

[0027] Figure 5 Shows Figure 4 A schematic top view of a bracket; and

[0028] Figure 6 A schematic structural diagram of another embodiment of the artificial valve stent of the present invention is shown.

[0029] The above drawings include the following reference numerals:

[0030] 10. Bracket; 11. First grid segment; 12. Second grid segment; 13. Limiting segment; 131. "U"-shaped structure; 14. Barb; 15. Connecting ear; 20. Sealing membrane; 30. Leaflet; 40. Developing component; 50. Avoidance notch. DETAILED DESCRIPTION

[0031] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0032] like Figures 1 to 6 As shown, the artificial valve of this embodiment includes: a stent 10, a sealing membrane 20 and a leaflet 30. The stent 10 includes a first mesh segment 11, a second mesh segment 12 and a limiting segment 13 connected to each other, the second mesh segment 12 is located between the first mesh segment 11 and the limiting segment 13, the second mesh segment 12 is surrounded by a barrel-shaped structure, the diameter of the first mesh segment 11 increases from the direction close to the second mesh segment 12 to the direction away from the second mesh segment 12, and the first mesh segment 11 is an irregular shape with an avoidance notch, and the limiting segment 13 has an outward flange. The sealing membrane 20 is arranged on the stent 10. The leaflet 30 is arranged on the second mesh segment 12 so that the flow direction of the fluid is from the first mesh segment 11 to the limiting segment 13.

[0033] By applying the technical solution of the present invention, the artificial valve is transported to a position beyond the target position in the right ventricle through a conveying device. The limiting segment is first released. According to the developing point of the vertex of the limiting segment, the conveyor is rotated as a whole to adjust the circumferential direction of the artificial valve so that the "D"-shaped structure of the valve after release can correspond to the "D"-shaped valve ring of the tricuspid valve. The artificial valve is withdrawn, and the flange of the limiting segment will contact the distal end of the natural leaflet or the tendon to form a blocking limit. Then the conveying device releases the second mesh segment, and the diameter of the second mesh segment increases and is stuck in the tricuspid valve ring. Finally, the first mesh segment is released, and the diameter of the first mesh segment increases from the direction close to the second mesh segment to the direction away from the second mesh segment, so that the first mesh segment will form a limit in another direction to prevent the valve from falling into the right ventricle. The above structure makes the fixing effect of the artificial valve at the tricuspid valve better. The technical solution of the present invention effectively solves the problems of adaptability and circumferential positioning of the artificial valve and human organs. The avoidance notch can avoid the position of the coronary sinus ostium, and at the same time can ensure that the atrioventricular node is not compressed and the blood of the coronary sinus is not blocked from flowing back to the right atrium. The first grid segment 11 can be a regular shape such as a sieve hole, or an irregular shape.

[0034] like Figure 1 and Figure 3As shown, in the technical solution of this embodiment, the limiting segment 13 is connected to the second grid segment 12, and the limiting segment 13 is at least one "U"-shaped structure 131, and the vertex of the "U"-shaped structure 131 extends toward the first grid segment 11. The "U"-shaped structure 131 is easy to set up and process, and the "U"-shaped structure 131 has a smooth transition, which will not cause damage to the organs of the body. The bending part of the "U"-shaped structure 131 is an arc transition, which ensures that the stress of the stent 10 will not be concentrated, and will not harm the organs and tissues of the body. It should be noted that the artificial valve of this embodiment can be used to replace the mitral valve or tricuspid valve of the human body. The limiting segment 13 can also be a "V"-shaped structure, or a wavy structure.

[0035] like Figure 3 As shown, in the technical solution of this embodiment, the two ends of the "U"-shaped structure are respectively connected to the second mesh segment 12. The above structure is compact and easy to use. Specifically, the limiting segment 13 and the second mesh segment 12 and the first mesh segment 11 can be laser cut by a tube, so that the connection between the first mesh segment 11, the second mesh segment 12 and the limiting segment 13 has a smooth transition. The same product can also be made by weaving wire.

[0036] like Figure 1 and Figure 3 As shown, in the technical solution of this embodiment, the limiting segment 13 is a plurality of "U"-shaped structures, and the plurality of "U"-shaped structures are evenly distributed at the first end of the second grid segment 12. This ensures that the artificial valve is subjected to a relatively balanced force when it interacts with body tissue. Specifically, the plurality of "U"-shaped structures can be arranged at intervals, or the ends of adjacent "U"-shaped structures can be connected at the same connection point, so that the limiting segment 13 composed of the plurality of "U"-shaped structures is a wavy structure. Further specifically, there are three "U"-shaped structures, and there are three leaflets 30, and the three leaflets 30 are arranged one by one corresponding to the three "U"-shaped structures. The above structure further ensures that the installation of the artificial valve is relatively stable. Taking the tricuspid valve as an example, the three "U"-shaped structures are in contact with the leaflets or myocardial tissue for positioning and fixing; then the second grid and the first grid are released, and the valve is stuck at the tricuspid valve. When the ventricle relaxes, blood flows from the right atrium into the right ventricle through the artificial valve; when the heart contracts, the blood pressure closes the artificial valve, putting pressure on the valve toward the atrium. The three "U"-shaped structures and tissues provide a reaction force to fix the valve in the tricuspid valve position.

[0037] like Figure 1 and Figure 3As shown, in the technical solution of this embodiment, the first grid segment 11 is a trumpet-shaped structure. The trumpet-shaped structure of the first grid segment 11 ensures that the first grid segment 11 forms a limit on another angle of the artificial valve, that is, the artificial valve will not fall into the ventricle from the installation position. On the other hand, since the sealing film 20 is installed on the first grid segment 11 and the second grid segment, when the first grid segment 11 and the second grid segment 12 are in contact with the body's tissue, paravalvular leakage is avoided. The first grid segment 11 is composed of two, three or multiples of three petal-shaped support bars, and the support bars are evenly arranged circumferentially. The avoidance gap of the first grid segment 11 is a fan-shaped structure. Specifically, a petal-shaped support bar does not need to be provided with a coating, so that the avoidance gap has connecting ribs, and the connecting ribs connect the support bars on both sides of the avoidance gap. Of course, the avoidance gap may also be provided with connecting ribs.

[0038] like Figure 1 As shown, in the technical solution of this embodiment, the stent 10 further includes a plurality of connecting ears 15, and the plurality of connecting ears 15 are arranged at the first end of the first mesh segment 11. The arrangement of the connecting ears 15 facilitates the connection between the artificial valve and the delivery device. Specifically, a connecting hole is arranged on the connecting ear 15, and the end with a small diameter of the first mesh segment 11 is connected to the second mesh segment 12.

[0039] like Figure 1 As shown, in the technical solution of this embodiment, the stent 10 also includes a barb 14, which is connected to the second mesh segment 12 and extends in a direction away from the central axis of the second mesh segment 12, pointing in the direction of the first mesh. The second mesh segment 12 is provided with a barb 14, which can penetrate into the tissue around the autologous valve to play a fixing role. In the technical solution of this embodiment, the angle between the barb 14 and the central axis of the second mesh segment 12 is 10 degrees to 80 degrees, preferably 60 degrees. The length of the barb 14 is between 1 mm and 10 mm.

[0040] like Figure 1 As shown, in the technical solution of this embodiment, there are multiple barbs 14. The structure of multiple barbs 14 makes the artificial valve and body tissue have more points of force, and the fixation of the artificial valve is more stable. Specifically, the number of barbs 14 is three groups or multiples of three groups.

[0041] like Figure 1 and Figure 3 As shown, in the technical solution of this embodiment, the length of the barb 14 is 1 mm to 10 mm. Preferably, the length of the barb 14 is 3 mm. The barb 14 fixes the artificial valve without stabbing other organs due to being too long, or causing unstable fixation due to being too short.

[0042] like Figure 4 and Figure 5As shown, in the technical solution of this embodiment, the artificial valve also includes a developing component 40, and the developing component 40 is arranged on the bracket 10. The arrangement of the developing component 40 facilitates circumferential positioning. The developing component 40 can be a metal with good developing properties, such as platinum, gold, or platinum-iridium alloy. After the artificial valve enters the body, with the assistance of the developing device, the developing component 40 can be clearly displayed on the device screen to help the valve be clearly positioned.

[0043] like Figure 4 and Figure 5 As shown, in the technical solution of this embodiment, the developing component 40 is located at the distal vertex of the "U"-shaped structure of the limiting section, and at least one "U"-shaped structure has a developing component. The developing component 40 can be at multiple "U"-shaped structure vertices, but the developing component on at least one vertex is different from the other vertices, which can distinguish the circumferential direction of the artificial valve. When multiple "U"-shaped structures have developing points, the valve positioning is more accurate. Figure 4 In the embodiment, the three or more "U"-shaped structure vertices are provided with developing components 40, and the number of developing components at each vertex is different, namely 1, 2, and 3, and each vertex can be distinguished from each other. When the distal end of the valve is released from the sheath, the circumferential position of the valve can be confirmed according to the different developing components, and the "D"-shaped structure valve can be made to correspond to the "D"-shaped anatomical structure of the human body by rotating the delivery system, and then the valve can be completely released.

[0044] like Figure 4 As shown, in the technical solution of this embodiment, the first grid segment 11 is provided with a sealing film 20, and the first grid segment 11 has an avoidance notch. The avoidance notch can effectively avoid the coronary vein orifice, and the developing component 40 is arranged corresponding to the leaflet, so that the position of the leaflet can be determined by the position of the developing component 40 to determine whether it is properly placed.

[0045] like Figure 4 and Figure 5 As shown, as another embodiment, the cross section of the second grid segment 12 is "D" shaped, and the avoidance notch of the first grid segment axially corresponds to the connection between the straight segment and the arc segment of the "D" shape. The above structure better adapts to the structure of human organs.

[0046] The valve is in a "D" shape, and the three leaflets 30 are not completely the same, and the shape of the leaflets on the straight sides is different from the shape of the leaflets on the curved sides.

[0047] The outer wall of the stent 10 is provided with barbs 14, which can penetrate the tissue around the valve when the heart valve (artificial valve) is released to the target position, thereby strengthening the fixation. After the heart valve is released, the barbs 14 penetrate the human valve and are not easily displaced.

[0048] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. An artificial valve, characterized in that: include: A bracket (10), the bracket (10) comprising a first grid segment (11), a second grid segment (12) and a limiting segment (13) which are connected to each other, the second grid segment (12) being located between the first grid segment (11) and the limiting segment (13), the second grid segment (12) forming a barrel-shaped structure, the diameter of the first grid segment (11) increasing from a direction close to the second grid segment (12) to a direction away from the second grid segment (12), the first grid segment (11) having an avoidance notch, and the limiting segment (13) having an outward flange; A sealing film (20), the sealing film (20) being arranged on the support (10); A flap (30), the flap (30) being arranged on the second mesh segment (12) so that the flow direction of the fluid is from the first mesh segment (11) to the limiting segment (13); The limiting segment (13) is connected to the second grid segment (12), the middle portion of the limiting segment (13) extends in the direction of the first grid segment (11), and the two ends of the "U"-shaped structure are respectively connected to the second grid segment (12); The limiting segment (13) is a plurality of "U"-shaped structures, and the plurality of "U"-shaped structures are evenly distributed at the far end of the second grid segment (12); The artificial valve further comprises a developing component, which is arranged on the support (10); the developing component is located at the distal vertex of the limiting section (13), and the developing component on at least one vertex is different from that on the other vertices, and is used to distinguish the circumferential positioning of the valve, and the developing component is a metal.

2. The artificial valve according to claim 1, characterized in that: There are three "U"-shaped structures and three leaflets (30).

3. The artificial valve according to claim 1, characterized in that: The first grid segment (11) is a trumpet-shaped structure, and the first grid segment (11) is composed of two, three or multiples of three petal-shaped support bars, and the support bars are evenly arranged in the circumferential direction.

4. The artificial valve according to claim 3, characterized in that: The first grid segment (11) contains an avoidance gap and is a fan-shaped structure.

5. The artificial valve according to claim 1, characterized in that: The stent (10) further comprises a plurality of connection ears (15), wherein the plurality of connection ears (15) are arranged at the proximal end of the first mesh segment (11).

6. The artificial valve according to claim 1, characterized in that: The bracket (10) is manufactured by cutting or weaving.

7. The artificial valve according to any one of claims 1 to 6, characterized in that: The bracket (10) further comprises a barb (14), wherein the barb (14) is connected to the second mesh segment (12) and extends in a direction away from the central axis of the second mesh segment (12).

8. The artificial valve according to claim 7, characterized in that: The barbs (14) extend outwardly and obliquely in the direction of the first mesh segment (11).

9. The artificial valve according to claim 8, characterized in that: There are a plurality of barbs (14); the angle between the barbs (14) and the outer side wall of the second mesh segment (12) is between 10 and 80 degrees; and the length of the barbs is between 1 mm and 10 mm.

10. The artificial valve according to any one of claims 1 to 6, characterized in that: The first grid segment (11) is provided with the sealing film (20), and the notch is avoided from being covered by the sealing film.

11. The artificial valve according to claim 10, characterized in that: The cross section of the second grid segment (12) is in the shape of a letter D, and the avoidance notch is connected at the junction of the straight segment and the lower edge of the arc segment of the letter D.

12. The artificial valve according to claim 11, characterized in that: The limiting section (13) and the apex of the outwardly facing flange corresponding to the "D"-shaped straight section are provided with a developing point, which indicates the direction and position of the valve when released, and performs circumferential positioning.

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