Valve prosthesis

Abstract

The valve prosthesis comprises a support, a covering film and a valve leaflet assembly, a main body portion of the support comprises a plurality of suture rods arranged at intervals in the circumferential direction, the two ends of each suture rod are connected with an outflow end and an inflow end respectively, the covering film comprises a first covering film, and the first covering film is arranged on the side wall of the support and connected with the valve leaflet assembly. The first covering film comprises a first covering film connecting part and a first covering film main body, the first covering film connecting part protrudes towards the outflow end, the first covering film connecting part comprises a valve angle connecting part and a transition part which are connected with each other, the valve angle connecting part is connected with the valve leaflet and the suture rod, and the transition part is used for connecting the valve angle connecting part and the first covering film main body; the supporting structure is arranged on the transition part and is fixed on the transition part, so that the surface of the transition part is flattened, the transition part is kept in an unfolded state, the transition part can be prevented from being unflattened due to wrinkles, and blood is prevented from being retained in the transition part to generate thrombus.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional medical devices, in particular to a valve prosthesis. BACKGROUND

[0002] When the native heart valve is narrowed, or the native valve leaks or regurgitates (such as calcification of the valve leaflet), heart valve replacement can be performed. In one treatment scheme, the native valve can be removed and replaced with a valve prosthesis. The valve prosthesis includes a stent, a covering and valve leaflets. In order not to block the coronary blood flow or re-intervention for coronary surgery, the middle part of the stent is in a hollow state except for the suture rods used to suture the valve corners of the valve leaflets. The valve leaflets are arranged inside the stent and connected to the suture rods through the valve corners of the valve leaflets, and the covering is wrapped around the inflow end of the stent. At this time, the area below the valve corner of the valve leaflet sutured on the suture rod (that is, the area towards the inflow end) is wrapped by the covering, and the covering in this area is prone to wrinkle and be uneven before and after the valve prosthesis is released or with the beating of the heart. Blood is prone to stagnate in this area, thereby causing thrombosis. SUMMARY

[0003] Therefore, it is necessary to provide a valve prosthesis, which includes an inflow end and an outflow end, the valve prosthesis includes a stent, a covering and a valve leaflet assembly, the stent includes an outflow end, a main body and an inflow end connected in sequence, the main body includes a plurality of suture rods arranged circumferentially and spaced apart, both ends of the suture rod are connected to the outflow end and the inflow end respectively, the valve leaflet assembly includes a plurality of valve leaflets, and adjacent two valve leaflets are sutured on the same suture rod, the covering is arranged at least on the inflow end, the covering includes a first covering, the first covering is arranged on the side wall of the stent and connected to the valve leaflet assembly, the first covering includes a first covering connecting part and a first covering main body, the first covering connecting part is protruded towards the outflow end, the first covering connecting part includes a valve corner connecting part and a transition part connected to each other, the valve corner connecting part is connected to the valve leaflet and the suture rod, and the transition part is connected between the valve corner connecting part and the first covering main body, wherein a support structure is arranged on the transition part, and the support structure is fixed on the transition part to smooth the surface of the transition part.

[0004] Compared with the prior art, the valve prosthesis has the following beneficial effects:

[0005] The valve prosthesis comprises a plurality of suture rods arranged in a circumferential direction, the two ends of the suture rods are connected to the outflow end and the inflow end respectively, so that the coronary blood flow is not blocked or the coronary surgery is performed by re-intervention, meanwhile, the first covering film comprises a first covering film connecting part and a first covering film main body, the first covering film connecting part is protruded towards the outflow end, the first covering film connecting part comprises a commissure connecting part and a transition part connected to each other, the commissure connecting part is connected to the valve leaflet and the suture rod, the transition part is connected between the commissure connecting part and the first covering film main body, a support structure is arranged on the transition part, the support structure is fixed on the transition part to smooth the surface of the transition part, before and after the valve prosthesis is released or along with the contraction and diastole of the heart, the transition part can be prevented from being wrinkled and uneven, so that blood is prevented from being retained in the transition part to generate thrombus, and a safety hazard is avoided. BRIEF DESCRIPTION OF DRAWINGS

[0006] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the embodiments or the prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments described in the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0007] Figure 1 A structure diagram of the valve prosthesis in an embodiment of the present application;

[0008] Figure 2 A structure diagram of the covering film in an embodiment of the present application;

[0009] Figure 3 An expanded structure diagram of the covering film in an embodiment of the present application;

[0010] Figure 4 A structure diagram of the stent in an embodiment of the present application;

[0011] Figure 5 A structure diagram of the valve prosthesis in an embodiment of the present application;

[0012] Figure 6 An expanded structure diagram of the stent in an embodiment of the present application;

[0013] Figure 7 A compressed structure diagram of the stent in an embodiment of the present application;

[0014] Figure 8 A structure diagram of part of the valve prosthesis in an embodiment of the present application;

[0015] Figure 9Part structure diagram of the valve prosthesis in an embodiment of the present application is shown in the figure.

[0016] Figure 10 Part structure diagram of the valve prosthesis in an embodiment of the present application is shown in the figure.

[0017] Figure 11 Part structure diagram of the valve prosthesis in an embodiment of the present application is shown in the figure. DETAILED DESCRIPTION

[0018] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application will be described in detail below with reference to the drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. It will be apparent, however, to one skilled in the art that the present application can be practiced without some or all of these specific details. In other instances, well known process steps have not been described in detail in order to avoid unnecessarily obscuring the present application. The use of the same reference numerals in different drawings indicates similar or identical components.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0020] In the field of interventional medical devices, the "distal end" is generally defined as the end that is distal to the operator during a procedure, and the "proximal end" is defined as the end that is proximal to the operator during a procedure. A valve prosthesis generally includes an open state and a closed state, in which blood flow can pass through the valve prosthesis when the valve prosthesis is in the open state, and blood flow is blocked by the valve prosthesis when the valve prosthesis is in the closed state. In the open state of the valve prosthesis, with reference to Figure 1 , the end through which blood flow enters the valve prosthesis is defined as the inflow end 242, and the end through which blood flow exits the valve prosthesis is defined as the outflow end 241.

[0021] The present embodiment provides a valve prosthesis 200 for interposition in a valve position of an aortic valve, a mitral valve, a tricuspid valve, a pulmonary valve, or a vascular valve, etc., to replace a native valve to achieve heart valve replacement. As shown in Figure 1 The valve prosthesis 200 includes a stent 210, a covering 260, and a leaflet assembly 230, the stent 210 includes an outflow end portion 211, a main body portion 212, and an inflow end portion 213 connected in sequence, the main body portion 212 includes a plurality of suture rods 2121 arranged circumferentially and spaced apart, the two ends of the suture rod 2121 are connected to the outflow end portion 211 and the inflow end portion 213 respectively, the leaflet assembly 230 includes a plurality of leaflets 2301, adjacent two leaflets 2301 are sutured on the same suture rod 2121, and the covering 260 is arranged at least at the inflow end portion 213.

[0022] Referring to Figure 2 and Figure 3 , the covering 260 includes a first covering 2601, the first covering 2601 is arranged on the side wall of the stent 210 and connected with the leaflet assembly 230, the first covering 2601 includes a first covering connecting part 2601a and a first covering main body 2601b, the first covering connecting part 2601a is protruded towards the outflow end 241, the first covering connecting part 2601a includes a commissure connecting part 2601a1 and a transition part 2601a2 connected with each other, the commissure connecting part 2601a1 is connected with the leaflet 2301 and the suture rod 2121, the transition part 2601a2 is connected between the commissure connecting part 2601a1 and the first covering main body 2601b. Further combining Figure 1 , the transition part 2601a2 is provided with a support structure 300, the support structure 300 is fixed on the transition part 2601a2 to flatten the surface of the transition part 2601a2, so that the transition part 2601a2 remains in an unfolded state. Wherein, the support structure 300 can be fixed on the transition part 2601a2 by sewing, gluing or welding.

[0023] The above-mentioned valve prosthesis 200 includes a plurality of suture rods 2121 arranged circumferentially and spaced apart by arranging the main body part 212, the two ends of the suture rod 2121 are connected with the outflow end part 211 and the inflow end part 213 respectively, so as not to block the coronary blood flow or to perform coronary surgery by re-intervention, at the same time, the first covering 2601 includes a first covering connecting part 2601a and a first covering main body 2601b, the first covering connecting part 2601a is protruded towards the outflow end 241, the first covering connecting part 2601a includes a commissure connecting part 2601a1 and a transition part 2601a2 connected with each other, the commissure connecting part 2601a1 is connected with the leaflet 2301 and the suture rod 2121, the transition part 2601a2 is used to connect the commissure connecting part 2601a1 and the first covering main body 2601b, the transition part 2601a2 is provided with a support structure 300, the support structure 300 is fixed on the transition part 2601a2 to flatten the surface of the transition part 2601a2, so that the transition part 2601a2 remains in an unfolded state, before and after the valve prosthesis 200 is released or with the contraction and relaxation of the heart, the transition part 2601a2 can be prevented from being wrinkled and not flat, so as to prevent blood from being retained in the transition part 2601a2 to generate thrombus and avoid safety hazards.

[0024] In the embodiment, the covering 260 further includes a second covering 2602 connected with the first covering 2601, the first covering 2601 is arranged on the inner wall of the stent 210, and the second covering 2602 is arranged on the outer wall of the stent. In other embodiments, only the first covering 2601 can be arranged.

[0025] In the embodiment, the support structure 300 comprises a rod structure 3000, which is connected with at least one of the suture rod 2121 and the inflow end 213.

[0026] Specifically, referring to Figure 4 , the support structure 300 comprises a closed structure 300a surrounded by the rod structure 3000, which is compressed as the stent 210 is radially contracted and expanded as the stent 210 is radially expanded, so that the valve prosthesis 200 is better adaptable and flexible, thereby adapting to the compression and release process of the valve prosthesis 200 and the contraction and expansion process of the heart. Further, the rod structure 3000 comprises a first rod 301, a second rod 302 and a third rod 303, which sequentially surround the closed structure 300a in the same clockwise direction as the suture rod 2121, wherein at least the third rod 303 of the first rod 301, the second rod 302 and the third rod 303 is part of the inflow end 213, so that the support structure 300 and the inflow end 213 can share a part of the structure, which can simplify the preparation process of the stent 210, while reducing the number of rods to reduce the compression diameter of the valve prosthesis, thereby enabling the valve prosthesis to enter a smaller sheath, thereby reducing damage to the human body and facilitating operation. In the embodiment, two closed structures 300a are provided on the same transition portion 2601a2, which are respectively arranged on both sides of the suture rod 2121 and share one suture rod 2121. In other embodiments, one or more closed structures 300a can be provided on the same transition portion 2601a2.

[0027] In another embodiment, referring to Figure 5 and Figure 6 , the rod structure 3000 comprises a first rod 301 and a second rod 302, which sequentially surround the closed structure 300a as the suture rod 2121, wherein at least one of the first rod 301 and the second rod 302 has a curved shape, such as the second rod 302 comprising a first rod portion 302a and a second rod portion 302b, which are connected to each other to form a curved shape, and the end of the first rod 301 connected with the second rod 302 also has a curved shape, referring to Figure 6 and Figure 7 , the curved shape can make the support structure 300 more easily compressed as the stent 210 is radially contracted and expanded as the stent 210 is radially expanded, and more flexible. In the embodiment, the first rod 301 can also be part of the inflow end 213. In other embodiments, the first rod 301 and the second rod 302 can be movably connected, which can also achieve more flexible activity of the stent through mechanical movable connection.

[0028] In another embodiment, referring to Figure 8 , the support structure 300 comprises support units 300b, one end of the support units 300b is connected with at least one of the suture rods 2121 and the inflow end portion 213, the support units 300b comprise at least one free end 300b1, and the support units 300b comprise rod-like structures 3000. In the embodiment, the support units 300b are staggered on both sides of the suture rods 2121, and in other embodiments, referring to Figure 9 , the support units 300b can also be symmetrically distributed on both sides of the suture rods 2121. In an embodiment, referring to Figure 10 , the support units 300b comprise Y-shaped or multi-branch-shaped structures, so as to better support the transition portion 2601a2, and also to achieve the effect of being easier to compress along with the radial contraction of the stent 210 and the closed structure to expand along with the radial expansion of the stent 210.

[0029] Further, referring again to Figure 6 and Figure 8 , the stent 210 comprises a plurality of stent rods 2100, and the rod diameter of at least part of the rod-like structures 3000 of the support structure 300b is smaller than the rod diameter of the stent rods 2100, so as to achieve the effect of being easier to compress along with the radial contraction of the stent 210 and the closed structure to expand along with the radial expansion of the stent 210, while also achieving the effect of supporting the transition portion 2601a2.

[0030] Further, referring to Figures 8 to 10 , the free end 300b1 of the rod-like structure 3000 is softer than other positions of the rod-like structure 3000, so as to avoid the free end from piercing through the transition portion 2601a2, and to achieve better safety.

[0031] Referring to Figure 11 , in another embodiment, the suture rods 2121 are fixed on the transition portion 2601a2 by means of a third suture line 2204, and the third suture line 2204 is provided with a plurality of cross-stitch points 2204a along the suture rods 2121, which also achieves the effect of flattening the transition portion 2601a2, while not needing to design additional rod-like structures.

[0032] The technical features of the above-described embodiments can be combined in any manner. In order to make the description concise, all possible combinations of the technical features in the above-described embodiments are not described, and as long as the combinations of the technical features do not exist contradictions, it should be considered that they are within the scope of the present disclosure.

[0033] The above-described embodiments only express several implementation manners of the utility model, the description is more specific and detailed, but can not therefore be understood as the limitation of the utility model patent range. It should be pointed out that for ordinary skilled person in the art, without departing from the utility model concept, several modifications and improvements can be made, which belong to the protection range of the utility model. Therefore, the protection range of the utility model patent should be subject to the appended claims.

Claims

1. A valve prosthesis comprising an inflow end and an outflow end, characterized in that, The valve prosthesis comprises a stent, a cover and a leaflet assembly, the stent comprises an outflow end, a main body and an inflow end connected in sequence, the main body comprises a plurality of suture rods arranged in a circumferential direction, two ends of the suture rods are connected to the outflow end and the inflow end respectively, the leaflet assembly comprises a plurality of leaflets, two adjacent leaflets are sutured on the same suture rod, the cover is arranged at least on the inflow end, the cover comprises a first cover, the first cover is arranged on the side wall of the stent and connected to the leaflet assembly, the first cover comprises a first cover connecting part and a first cover main body, the first cover connecting part is protruded towards the outflow end, the first cover connecting part comprises a commissure connecting part and a transition part connected to each other, the commissure connecting part is connected to the leaflet and the suture rod, the transition part is connected between the commissure connecting part and the first cover main body, wherein a support structure is arranged on the transition part, the support structure is fixed on the transition part to smooth the surface of the transition part.

2. The valve prosthesis of claim 1, wherein, The support structure comprises a rod structure, the rod structure is connected to at least one of the suture rod and the inflow end.

3. The valve prosthesis of claim 2, wherein, The support structure comprises a closed structure surrounded by the rod structure, the closed structure is compressed when the stent is radially contracted, and the closed structure is expanded when the stent is radially expanded.

4. The valve prosthesis of claim 3, wherein, The rod structure comprises a first rod, a second rod and a third rod, the first rod, the second rod, the third rod and the suture rod surround the closed structure in sequence in the same clock direction, wherein at least the third rod among the first rod, the second rod and the third rod is a part of the inflow end.

5. The valve prosthesis of claim 3, wherein, The rod structure comprises a first rod and a second rod, the first rod, the second rod and the suture rod surround the closed structure, wherein at least one of the first rod and the second rod has a curved shape, or the first rod and the second rod are movably connected.

6. The valve prosthesis of claim 2, wherein, The support structure comprises a support unit, one end of the support unit is connected to at least one of the suture rod and the inflow end, and the support unit comprises at least one free end.

7. The valve prosthesis of claim 6, wherein, The support unit comprises a Y shape or a multi-branch shape.

8. The valve prosthesis of claim 2, wherein, The stent comprises a plurality of stent rods, and a rod diameter of at least part of the rod structure of the support structure is smaller than a rod diameter of the stent rods.

9. The valve prosthesis of claim 6, wherein, The free end in the rod structure is softer than other positions in the rod structure.

10. The valve prosthesis of claim 1, wherein, The suture rod is arranged on the surface of the transition part and fixed to the transition part by a suture line, a plurality of cross suture points are arranged on the suture line along the suture rod, and the support structure comprises a plurality of the cross suture points.

Images