CN218899817U - Aortic valve device - Google Patents

Abstract

The utility model relates to an aortic valve device, which comprises an inflow end and an outflow end, wherein the inflow end is one end of blood flowing into the aortic valve device, the outflow end is one end of blood flowing out of the aortic valve device, the aortic valve device comprises a bracket, valve leaflets and a sealing ring, the valve leaflets are fixed in the bracket, the sealing ring is arranged on the inflow end of the bracket, the sealing ring is in an inverted truncated cone shape, and the minimum radial dimension of one side of the sealing ring, which is close to the outflow end, is larger than the maximum radial dimension of one side of the sealing ring, which is close to the inflow end. When acting on the aorta, the inverted truncated cone-shaped sealing ring has one end with larger radial dimension just clamped on the aortic valve ring, so that the perivalvular leakage can be effectively prevented. Meanwhile, the sealing ring is arranged in an inverted circular truncated cone shape, so that the part with larger radial dimension is close to one side of the outflow end, the sealing ring can be prevented from pressing ventricular conduction tissues, and further the sealing ring is prevented from affecting heart beating and blood flowing.

Description

Aortic valve device

Technical Field

The utility model relates to the field of interventional medicine, in particular to an aortic valve device.

Background

At present, the surgical operation treatment for treating the heart valve disease is mainly valve replacement operation, but the existing valve cannot be tightly attached to an annulus, so that the phenomenon of paravalvular leakage is generated, and the existing valve is easy to squeeze ventricular conduction tissues to influence the beating of the heart.

Disclosure of Invention

To overcome the problems in the prior art, the present utility model provides an aortic valve assembly.

The technical problem to be solved by the utility model is to provide an aortic valve device, which comprises an inflow end and an outflow end, wherein the inflow end is one end of blood flowing into the aortic valve device, the outflow end is one end of blood flowing out of the aortic valve device, the aortic valve device comprises a bracket, valve leaflets and a sealing ring, the valve leaflets are fixed in the bracket, the sealing ring is arranged on the inflow end of the bracket, the sealing ring is in an inverted truncated cone shape, and the minimum radial dimension of one side of the sealing ring, which is close to the outflow end, is larger than the maximum radial dimension of one side of the sealing ring, which is close to the inflow end.

In some embodiments of the present utility model, the seal ring includes a seal ring support woven from woven wires, the seal ring support including a plurality of lattice structures, two adjacent lattice structures being connected to each other, the plurality of lattice structures enclosing to form a ring-shaped seal ring support.

In some embodiments of the utility model, the dimension of the mesh structure in the circumferential direction of the seal ring support near the outflow end is greater than the dimension of the mesh structure in the circumferential direction of the seal ring support near the inflow end.

In some embodiments of the present utility model, an end of the mesh structure near the outflow end protrudes toward the central axis of the seal ring support to form a first hanging wire structure; and one end of the grid structure, which is close to the inflow end, protrudes towards the central axis of the sealing ring support to form a second hanging wire structure.

In some embodiments of the present utility model, the seal ring includes an annular seal ring support, the seal ring support includes a plurality of groove structures and inflow end connection structures, inflow ends of two adjacent groove structures are connected through the inflow end connection structures, and outflow ends of two adjacent groove structures are separated from each other.

In some embodiments of the utility model, the annular sealing ring stent is in a wave-like configuration after being cut flat and deployed along a longitudinal central axis parallel to the aortic valve apparatus.

In some embodiments of the utility model, a minimum dimension of the outflow end of the groove structure in the sealing ring carrier circumferential direction is greater than a maximum dimension of the inflow end of the groove structure in the sealing ring carrier circumferential direction.

In some embodiments of the utility model, the seal ring further comprises a cover film covering the surface of the seal ring support and a skirt wrap surrounding the cover film and the seal ring support.

In some embodiments of the utility model, the outflow end of the stent is inclined to the central axis of the stent to form a constriction.

In some embodiments of the utility model, the ratio of the height of the constriction to the height of the stent ranges from: 2/35 to 3/20; or/and the included angle between the direction of the closing-up structure facing the outflow end and the direction of the support in the axial direction and facing the outflow end ranges from 5 degrees to 20 degrees.

Compared with the prior art, the aortic valve device has the following advantages: when acting on the aorta, the inverted truncated cone-shaped sealing ring has one end with larger radial dimension just clamped on the aortic valve ring, so that the perivalvular leakage can be effectively prevented. Simultaneously, set up the sealing ring as the shape of falling round platform, make its radial dimension great part be close to outflow end one side, then can avoid the sealing ring oppression ventricle conductive tissue, and then avoid the sealing ring influences the flow of heart beat and blood.

Drawings

Fig. 1 is a schematic structural view of an aortic valve unit according to an embodiment of the present utility model.

Fig. 2 is a schematic view of a sealing ring support structure of an aortic valve unit according to an embodiment of the utility model.

FIG. 3 is a schematic diagram of a stent-graft seal of an aortic valve apparatus according to an embodiment of the utility model.

FIG. 4 is a schematic view of a sealing ring holder of an aortic valve unit according to another embodiment of the utility model.

Fig. 5 is a schematic view showing a seal ring separation structure of an aortic valve unit according to an embodiment of the utility model.

Fig. 6 is a schematic diagram of a stent structure of an aortic valve apparatus according to an embodiment of the present utility model.

Fig. 7 is a schematic view showing a stent deployment structure of an aortic valve apparatus according to an embodiment of the present utility model.

Fig. 8 is an enlarged view at a in fig. 7.

The attached drawings are used for identifying and describing: 100. an aortic valve device; 1. a bracket; 2. valve leaves; 3. a seal ring; 30. weaving filaments; 31. a seal ring support; 311. a grid structure; 301. a peak; 302. a connection section; 303. a trough; 312. a trough structure; 313. an inflow end connection structure; 314. an outflow end connection structure; 315. a connection part; 3111. a first hanging wire structure; 3112. a second hanging wire structure; 32. coating a film; 33. a skirt cloth; 11. a wave structure; 12. a straight rod; 13. sinus curved rod; 111. a closing-in structure; 112. a waveform; 121. the valve leaves are fixedly positioned; 131. a bending part.

Detailed Description

Exemplary embodiments of the present utility model will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present utility model are shown in the drawings, it should be understood that the present utility model may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the utility model to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

For purposes of more clarity in describing the structure of the present application, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical arts. Specifically, "distal" means an end far from the operator during a surgical operation, "proximal" means an end near the operator during a surgical operation, "axial" means a length direction thereof, and "radial" means a direction perpendicular to the "axial".

Referring to fig. 1, an aortic valve apparatus 100 is provided for treating aortic valve disorders. The aortic valve apparatus 100 includes an inflow end, which is an end where blood flows into the aortic valve apparatus 100, and an outflow end, which is an end where blood flows out of the aortic valve apparatus 100. The aortic valve device 100 comprises a stent 1, valve leaflets 2 and a sealing ring 3, wherein the valve leaflets 2 are fixed in the stent 1, the sealing ring 3 is arranged on the inflow end of the stent 1, and the sealing ring 3 is in an inverted truncated cone shape, namely in an inverted truncated cone shape structure. The minimum radial dimension of the side of the sealing ring 3 near the outflow end is larger than the maximum radial dimension of the side of the sealing ring 3 near the inflow end. When acting on the aorta, the inverted cone-shaped sealing ring 3 has one end with larger radial dimension just clamped on the aortic valve ring, so that the perivalvular leakage can be effectively prevented. Meanwhile, if the portion of the seal ring 3 having a large radial dimension is disposed at the intermediate position or at a position near the inflow end, it is possible to press the ventricular conduction tissue to affect the beating of the heart. The sealing ring 3 is arranged in an inverted truncated cone shape, so that a part with a larger radial dimension is close to one side of the outflow end, and the sealing ring 3 can be prevented from pressing ventricular conduction tissues, and further the sealing ring 3 is prevented from affecting heart beating and blood flow.

In other embodiments of the present utility model, the sealing ring 3 may be further configured such that the radial dimension of the middle is smaller than the radial dimension of the outflow end and the inflow end, thereby forming an i-like structure.

Referring to fig. 2 and 3, in an embodiment of the present utility model, the seal ring 3 includes a seal ring support 31 woven by the woven wires 30, the seal ring support 31 includes a plurality of grid structures 311, two adjacent grid structures 311 are connected to each other, and the plurality of grid structures 311 enclose to form a ring-shaped seal ring support 31. Specifically, the seal ring holder 31 is formed by winding a braid wire 30 around an annular mold and heat-setting. The knitting mode of the knitting yarn 30 is to knit a circle of knitting yarn ring with a wave-shaped structure on the annular mold in one direction, and the knitting yarn ring has a wave crest 301, a connecting section 302 and a wave trough 303. Then knitting a loop of the wavy structure in the opposite direction with the peaks 301 of the second loop of knitted loops axially aligned with the valleys 303 of the first loop of knitted loops, the connecting segments 302 of the second loop of knitted loops being wrapped around the connecting segments 302 of the first loop of knitted loops, the valleys 303 of the second loop of knitted loops axially aligned with the peaks 301 of the first loop of knitted loops. Finally, two adjacent grid structures 311 are mutually wound and connected, and a plurality of grid structures 311 are enclosed to form an annular sealing ring support 31. The seal ring support 31 woven by the method has a stable structure, so that the woven wires 30 cannot shift during film coating, and the positions of the woven wires 30 do not need to be adjusted during film coating, so that the seal ring support 31 is easier to be coated.

Further, the mesh structure 311 has a dimension R1 on the side closer to the outflow end than a dimension R2 on the side closer to the inflow end in the circumferential direction of the seal ring holder 31. So that the annular sealing ring support 31 formed by enclosing the grid structures 311 has an inverted truncated cone-shaped structure with a larger diameter at one end and a smaller diameter at the other end.

In an embodiment of the present utility model, the material of the braided wire 30 may be a material having elasticity, such as nickel-titanium wire, silica gel, and the like, and preferably nickel-titanium wire.

With continued reference to fig. 1, the height L1 of the sealing ring 3 should be less than or equal to the length of the inflow end of the bracket 1, so as to avoid that the length of the sealing ring 3 is greater than the inflow end of the bracket 1, so that the sealing ring 3 covers the released portion of the bracket 1 and further hinders the release of the bracket 1. And at the same time, the occurrence of neoplasms due to the too long length of the sealing ring 3 can be avoided. In the specific embodiment of the utility model, the height L1 of the sealing ring 3 is 12mm-14mm. The horizontal distance L2 between the portion of the seal ring 3 having the largest radial dimension and the portion having the smallest radial dimension is 4mm to 7mm.

Referring to fig. 4, in other embodiments of the present utility model, the seal ring 3 may include an annular seal ring holder 31, and the seal ring holder 31 is formed by cutting nickel-titanium sheet. Specifically, the seal ring support 31 is formed into a ring structure by heat setting after being cut from nickel-titanium sheet. The seal ring holder 31 cut from a nickel titanium sheet includes a plurality of groove structures 312 and a plurality of inflow end connection structures 313, and two adjacent groove structures 312 are connected by the inflow end connection structures 313. That is, one end of the groove-shaped structure 312 is a closed end, the other end is a free end, and the free ends of two adjacent groove-shaped structures 312 are connected by the inflow end connection structure 313. Further, one of the groove structures 312 includes an outflow end connecting structure 314 and two connecting portions 315, and the outflow end connecting structure 314 and the two connecting portions 315 are connected end to enclose the groove structure 312. Specifically, an end of one of the connection parts 315 is connected to one end of the outflow end connection structure 314, the other end of the outflow end connection structure 314 is connected to an end of the other connection part 315, an end of the connection part 315 remote from the outflow end connection structure 314 is connected to one end of the inflow end connection structure 313, and the other end of the inflow end connection structure 313 is connected to an end of the connection part 315 of the other groove structure 312. Finally, the connection manner of the groove structure 312 and the inflow end connection structure 313 is as follows: one of the groove structures 312 is connected to one of the inflow end connection structures 313, the inflow end connection structure 313 is connected to the next groove structure 312, the next groove structure 312 is connected to the next inflow end connection structure 313, and so on, a plurality of groove structures 312 are connected to a plurality of inflow end connection structures 313 to form the wavy seal ring support 31. I.e. the ring-shaped sealing ring holder 31 is in a wave-like configuration after being cut out and spread out parallel to the longitudinal centre axis of the aortic valve unit 100.

It will be appreciated that the outflow end connecting structure 314 may be circular arc, rectangular, zigzag, etc., and the sealing ring support 31 may have a sinusoidal wave structure, square wave structure, zigzag wave structure, etc. after being spread and unfolded along a longitudinal center axis parallel to the aortic valve unit 100.

The inflow end connection structure 313 is disposed proximate the inflow end and the outflow end connection structure 314 is disposed proximate the outflow end. The size of the outflow end connecting structure 314 along the circumferential direction of the sealing ring support 31 is greater than the size of the inflow end connecting structure 313 along the circumferential direction of the sealing ring support 31, so that the radial size of one side of the sealing ring 3 close to the outflow end is greater than the radial size of one side of the sealing ring 3 close to the inflow end, and the sealing ring 3 is in an inverted truncated cone shape.

It will be appreciated that in other embodiments of the present utility model, the seal ring support 31 may also be made of silicone by molding, specifically, injecting liquid silicone into a hot mold, and then solidifying, cooling and shaping the seal ring support 31 into a ring shape.

Referring to fig. 3 and 5, in an embodiment of the utility model, an end of the grid structure 311 near the outflow end protrudes toward the central axis of the seal ring support 31 to form a first hanging wire structure 3111, i.e. the peak 301 protrudes toward the central axis of the seal ring support 31 to form a first hanging wire structure 3111. One end of the grid structure 311 near the inflow end protrudes toward the central axis of the seal ring bracket 31 to form a second hanging wire structure 3112, that is, the trough 303 protrudes toward the central axis of the seal ring bracket 31 to form a second hanging wire structure 3112. The sealing ring 3 further comprises a covering film 32 and a skirt cloth 33, wherein the covering film 32 is provided with two layers, one layer of covering film 32 covers the outer surface of the sealing ring support 31, and the other layer of covering film 32 covers the inner surface of the sealing ring support 31. The cover film 32 completely covers the whole sealing ring support 31 through the two layers of the cover films 32, and the stability of the sealing ring support 31 can be kept by the two layers of the cover films 32, so that the sealing ring support 31 is more stable in structure. The skirt cloth 33 is wrapped on the covering film 32, and the skirt cloth 33 completely wraps the whole covering film 32 and the sealing ring support 31 and is sewn on the sealing ring support 31 through the first hanging wire structure 3111 and the second hanging wire structure 3112. Specifically, the suture thread for sewing the skirt cloth 33 sequentially passes through the plurality of first hanging thread structures 3111 of the plurality of mesh structures 311, thereby sewing the side of the skirt cloth 33 near the outflow end to the seal ring holder 31. And then, the other suture thread sequentially passes through a plurality of second hanging thread structures 3112 of a plurality of grid structures 311, so that one side of the skirt cloth 33 near the inflow end is sutured on the sealing ring bracket 31. Thereby firmly sewing the whole skirt cloth 33 to the seal ring holder 31. The first hanging wire structure 3111 and the second hanging wire structure 3112 may enable the skirt cloth 33 to be sewn to the seal ring bracket 31 more conveniently and stably.

It will be appreciated that the peaks 301 may protrude toward the central axis of the seal ring holder 31 toward the inflow end, may protrude toward a direction perpendicular to the central axis of the seal ring holder 31, or may protrude toward the central axis of the seal ring holder 31 toward the outflow end.

Further, after the seal ring holder 31 is sewn to the skirt 33, the seal ring 3 may be sewn to the holder 1 by sewing a thread through the skirt 33 and the seal ring 3. Specifically, the suture passes through the skirt 33 and then through the bracket 1, thereby fixing the seal ring 3 to the bracket 1.

In other embodiments of the present utility model, the cover film 32 may further include a layer, for example, a layer of the cover film 32 covers the inner surface and the outer surface of the seal ring support 31, a layer of the cover film 32 covers the outer surface of the seal ring support 31, or a layer of the cover film 32 covers the inner surface of the seal ring support 31. The skirt cloth 33 may cover only a part of the cover film 32 and the seal ring holder 31, for example, the skirt cloth 33 covers the seal ring holder 31 provided with the first hanging wire structure 3111 and the second hanging wire structure 3112. The skirt wrap 33 may also be omitted.

Referring to fig. 6 and 7, in an embodiment of the present utility model, the stent 1 is made of a nickel-titanium tube by cutting and heat setting. The support 1 comprises a wave structure 11, a straight rod 12 and a sinus bent rod 13, wherein the straight rod 12 is arranged in parallel with the axial direction of the support 1, the wave structure 11 is arranged at two ends of the support 1, two ends of the straight rod 12 are respectively connected with the wave structure 11 at two ends of the support 1, the sinus bent rod 13 is arranged adjacent to the straight rod 12 in the circumferential direction, and two ends of the sinus bent rod 13 are respectively connected with the wave structure 11 at two ends of the support 1. That is, the wave structures 11 are disposed at both ends of the stent 1, and the straight bar 12 and the sinus curved bar 13 are disposed between the two wave structures 11. After the aortic valve device 100 is released at the lesion site, the straight rod 12 serves to support the stent 1, and the sinus crank 13 is clamped to the sinus of the inner wall of the aorta, so that the aortic valve device 100 is stably clamped in the aorta. Through the arrangement of the sinus curved bar 13, the aortic valve device 100 is fixed in the aorta without suture, so that the operation of a doctor is simpler, the operation time is effectively shortened, the extracorporeal circulation time of a patient is shortened, the operation risk is reduced, and the operation safety and smoothness are ensured.

Further, the wave structure 11 disposed at the outflow end of the stent 1 is inclined toward the central axis of the stent 1 to form a constriction structure 111. I.e. the radial dimension of the constriction 111 is smaller than the radial dimension of the stent 1 at other locations than the constriction 111. By providing the constriction 111, the aortic valve assembly 100 can be assembled with easier access to the delivery sheath. Meanwhile, during the operation of implanting the aortic valve apparatus 100, it is necessary to cut the ascending aorta, then implant the aortic valve apparatus 100 into the cut ascending aorta through a conveyor, and then suture the cut ascending aorta. The closing structure 111 is arranged to prevent the outflow end of the stent 1 from scratching the inner wall of the ascending aorta during suturing.

With continued reference to fig. 6, the ratio of the height of the closing-up structure 111 to the height of the bracket 1 is: 2/35-3/20. Specifically, the height L3 of the closing-in structure 111 is 2mm to 4.5mm. The overall height L4 of the bracket 1 is 30mm-35mm. If the ratio of the height of the closing-up structure 111 to the height of the stent 1 is too large, that is, under the same angle, the height of the closing-up structure 111 is too high, which results in too far distance between the closing-up structure 111 and the inner wall of the ascending aorta, the endothelialization of the closing-up structure 111 is incomplete, and the blood flow is affected. If the ratio of the height of the closing-in structure 111 to the height of the bracket 1 is too small, that is, the height of the closing-in structure 111 is too low, the bracket 1 is difficult to shape, and the manufacturing difficulty of the bracket 1 is increased. Therefore, the ratio of the height of the closing-in structure 111 to the height of the bracket 1 is set to be 2/35-3/20, so that the endothelialization of the bracket 1 is ensured to be complete, the manufacturing difficulty of the bracket 1 is reduced, the manufacturing yield of the bracket 1 is ensured, and the manufacturing cost of the bracket 1 is reduced.

Referring to fig. 6 and 8, an included angle α between the closing-in structure 111 and the straight rod 12 is 5 ° -20 °, that is, an included angle between a direction of the closing-in structure 111 toward the outflow end and a direction of the support 1 axially and toward the outflow end, that is, a closing-in angle α of the closing-in structure 111 is 5 ° -20 °. If the closing angle α is too large, the closing structure 111 may easily damage the ascending aorta. If the closing angle α is too small, the distance between the closing structure 111 and the inner wall of the ascending aorta is too long, which results in incomplete endothelialization of the closing structure 111 and affects blood flow. Therefore, the included angle α between the closing-in structure 111 and the straight rod 12 is set to be 5 ° -20 °, so that the complete endothelialization of the closing-in structure 111 can be ensured, and the damage of the closing-in structure 111 to the inner wall of the ascending aorta can be avoided.

Meanwhile, the sealing ring 3 with a certain inclination angle between the closing structure 111 and the inverted truncated cone shape can make the aortic valve unit 100 easier to be loaded and stored on the conveyor, and the success rate of loading and storing the aortic valve unit 100 on the conveyor is higher.

With continued reference to fig. 7, the waveform structure 11 has 18 pairs of waveforms 112, that is, two waveforms 112 aligned with each other along the axial direction of the waveform structure 11 are a pair of waveforms 112, and 18 pairs of waveforms 112 are total. The number of the straight rods 12 is 3, the number of the sinus curved rods 13 is 6, the straight rods 12 are arranged in a axisymmetric manner along the central axis of the bracket 1, and the sinus curved rods 13 are arranged in a axisymmetric manner along the central axis of the bracket 1. If the waveform 112 of the waveform structure 11 exceeds 18 pairs, it may result in difficulty in compressing the aortic valve apparatus 100, which may result in difficulty in compressing the aortic valve apparatus 100 into a conveyor. If the number of the waves 112 of the wave structure 11 is less than 18 pairs, the stent 1 cannot be tightly attached to the inner wall of the ascending aorta. The waveform 112 of the waveform structure 11 is set to 18 pairs most suitably. Further, the number of the straight bars 12 is set to 3, and the number of the sinus curved bars 13 is set to 6. The wave form 112, the straight rod 12 and the sinus curved rod 13 are all multiples of 3, so that the straight rod 12 and the sinus curved rod 13 are more uniformly distributed after being symmetrically arranged along the central axis of the bracket 1. Thereby making the aortic valve assembly 100 more uniformly stressed and more conforming to the inner wall of the ascending aorta.

In other embodiments of the present utility model, the height L3 of the necking structure 111 may also be 1mm-5.5mm, and specifically, the height L3 of the necking structure 111 may be 2mm, 2.5mm, 3mm, and so on. The overall height L4 of the bracket 1 can also be 25mm-40mm. Specifically, the height L4 of the entire stand 1 may be 30mm, 32mm, 34mm, or the like. The included angle α between the closing-in structure 111 and the straight rod 12 may also be 0 ° -30 °, specifically, the included angle α may be 4 °, 25 °, 30 °, etc. The number of the straight bars 12 may be 2, 4, 6, 9, etc., and the number of the sinus curved bars 13 may be 2, 4, 9, 12, etc.

With continued reference to fig. 7, in the embodiment of the present utility model, the straight rod 12 is provided with leaflet fixing units 121, the leaflet fixing units 121 are in a hollow structure, the number of the leaflets 2 is 3, two ends of one leaflet 2 are respectively fixed on two adjacent leaflet fixing units 121, and a portion of the leaflet 2 close to the inflow is fixed on the skirt cloth 33. The sinus crank 13 is provided with a bending portion 131 which is provided in a sine wave bending manner. Specifically, both ends of one of the valve leaflets 2 are respectively fixed to two adjacent valve leaflet fixing positions 121, and the portion of this valve leaflet 2 adjacent to the inflow is sewn to the skirt cloth 33 by a suture thread, so that the valve leaflet 2 is firmly fixed in the stent 1. The curved portion 131 of the sinus curve 13 may be caught at the sinus of the aorta to support the aortic valve unit 100. And the sinusoidal bending arrangement of the bending portion 131 can make the sinus curve 13 perform expansion release better and make the aortic valve unit 100 more uniformly stressed.

Compared with the prior art, the aortic valve device has the following advantages:

1. according to the aortic valve device, when the inverted truncated cone-shaped sealing ring acts on an aorta, one end with a larger radial size is just clamped on the aortic valve ring, so that the perivalvular leakage can be effectively prevented. Simultaneously, set up the sealing ring as the shape of falling round platform, make its radial dimension great part be close to outflow end one side, then can avoid the sealing ring oppression ventricle conductive tissue, and then avoid the sealing ring influences the flow of heart beat and blood.

2. The sealing ring support formed by enclosing the grid structure is stable in structure, and is not easy to shift during film covering, so that the sealing ring support is easier to cover the film.

3. When the aortic valve device is clamped at the aortic valve lesion position, the aortic valve device can be extruded to generate a trend of moving towards the inflow end, and the part of the inverted conical structure, with the larger radial dimension, of the sealing ring can be tightly attached to the valve annulus of the aortic valve all the time, so that the part of the sealing ring, with the larger radial dimension, is prevented from crossing the valve annulus and cannot be tightly attached to the valve annulus.

4. The first hanging wire structure and the second hanging wire structure can enable the skirt cloth to be sewn on the sealing ring support more conveniently and stably.

5. Through the arrangement of the sinus curved bar, the aortic valve device is not required to be fixed in the aorta in a sewing mode, so that the operation of a doctor is simpler, the operation time is effectively shortened, the extracorporeal circulation time of a patient is shortened, the operation risk is reduced, and the operation safety and smoothness are ensured.

6. The arrangement of the closing-in structure enables the ascending aorta to avoid scratch on the inner wall of the ascending aorta caused by the outflow end of the bracket when the ascending aorta is sutured.

7. The included angle alpha between the closing-in structure and the straight rod is set to be 5-20 degrees, so that the closing-in structure can be completely endothelialized, and damage to the inner wall of the ascending aorta caused by the closing-in structure can be avoided.

8. The ratio of the height of the closing-in structure to the height of the support is set to be 2/35-3/20, so that the endothelialization of the support is guaranteed to be complete, the manufacturing difficulty of the support is reduced, the manufacturing yield of the support is guaranteed, and the manufacturing cost of the support is reduced.

The above description is only of the preferred embodiments of the present utility model and is not intended to limit the utility model, but any modifications, equivalents, improvements, etc. within the principles of the present utility model should be included in the scope of the present utility model.

Claims (10)

1. An aortic valve assembly comprising an inflow end for blood inflow into the aortic valve assembly and an outflow end for blood outflow from the aortic valve assembly, wherein: the aortic valve device comprises a support, valve leaflets and a sealing ring, wherein the valve leaflets are fixed in the support, the sealing ring is arranged on the inflow end of the support, the sealing ring is in an inverted truncated cone shape, and the minimum radial dimension of one side of the sealing ring, which is close to the outflow end, is larger than the maximum radial dimension of one side of the sealing ring, which is close to the inflow end.

2. The aortic valve apparatus as claimed in claim 1, wherein: the sealing ring comprises a sealing ring support formed by braiding wires, the sealing ring support comprises a plurality of grid structures, two adjacent grid structures are connected with each other, and the grid structures are enclosed to form an annular sealing ring support.

3. The aortic valve apparatus as claimed in claim 2, wherein: the dimension of the grid structure, which is close to the outflow end, along the circumferential direction of the sealing ring support is larger than the dimension of the grid structure, which is close to the inflow end, along the circumferential direction of the sealing ring support.

4. The aortic valve apparatus as claimed in claim 2, wherein: one end, close to the outflow end, of the grid structure protrudes towards the central axis of the sealing ring support to form a first hanging wire structure; and one end of the grid structure, which is close to the inflow end, protrudes towards the central axis of the sealing ring support to form a second hanging wire structure.

5. The aortic valve apparatus as claimed in claim 1, wherein: the sealing ring comprises an annular sealing ring support, the sealing ring support comprises a plurality of groove structures and inflow end connecting structures, inflow ends of two adjacent groove structures are connected through the inflow end connecting structures, and outflow ends of two adjacent groove structures are separated from each other.

6. The aortic valve apparatus as claimed in claim 5, wherein: the annular sealing ring support is in a wave-shaped structure after being cut, spread and unfolded along a longitudinal central shaft parallel to the aortic valve device.

7. The aortic valve apparatus as claimed in claim 5, wherein: the minimum dimension of the outflow end of the groove-shaped structure along the circumferential direction of the sealing ring support is larger than the maximum dimension of the inflow end of the groove-shaped structure along the circumferential direction of the sealing ring support.

8. The aortic valve apparatus as claimed in any one of claims 2 to 7, wherein: the sealing ring further comprises a covering film and skirt cloth, wherein the covering film covers the surface of the sealing ring support, and the skirt cloth wraps the covering film and the sealing ring support.

9. The aortic valve apparatus as claimed in claim 1, wherein: the outflow end of the support inclines to the central axis of the support to form a closing-in structure.

10. The aortic valve apparatus as claimed in claim 9, wherein: the height ratio range of the closing-in structure to the height of the bracket is as follows: 2/35 to 3/20; or/and the included angle between the direction of the closing-up structure towards the outflow end and the direction of the support in the axial direction and towards the outflow end ranges from 5 degrees to 20 degrees.

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