CN217186592U - Valve prosthesis - Google Patents

Abstract

The utility model discloses a valve prosthesis, valve prosthesis includes: valve support, diaphragm, valve leaf, one-way conduction device. The valve support comprises a first support and a second support which are sequentially arranged from inside to outside, the diaphragm comprises a first diaphragm and a second diaphragm, the first diaphragm is arranged on the inner circumferential surface and/or the outer circumferential surface of the first support, and the second diaphragm is arranged on the outer circumferential surface and/or the inner circumferential surface of the second support. The valve leaflet is arranged in the first support, the one-way conduction device is arranged between the first support and the second support, and the one-way conduction device is configured to be opened when the valve leaflet is opened so as to enable fluid between the first support and the second support to flow out, and to be closed when the valve leaflet is closed. Therefore, the blood can flow in one direction between the first bracket and the second bracket, the accumulation of the blood between the first bracket and the second bracket is avoided, the formation of thrombus is prevented, and the blood backflow is avoided.

Description

Valve prosthesis

Technical Field

The utility model relates to the field of medical equipment, especially, relate to a valve prosthesis.

Background

The human heart includes the left atrium, left ventricle, right atrium, and right ventricle. Blood flows through the various chambers, the flow direction of which is controlled by heart valves in the heart which act as one-way valves. The mitral valve is located between the left atrium and the left ventricle, the mitral valve is opened in diastole, blood flows from the left atrium to the left ventricle, and the mitral valve is closed in systole, so that the blood is prevented from flowing back to the left atrium from the left ventricle.

Mitral Regurgitation (MR) is the most prevalent valve disease. During ventricular systole, the MR-diseased mitral valve does not close completely, resulting in a regurgitation of blood back into the left atrium and even the pulmonary veins. To compensate for the regurgitated blood, the heart increases stroke volume to pump more blood. Long-term MR lesions can lead to elevated left atrial pressure, myocardial hypertrophy, enlarged left atrium, pulmonary hypertension, atrial fibrillation and even heart failure.

For moderate and severe reflux patients, the traditional treatment mode is to repair or replace the patients through surgical thoracotomy, but the operation has high risk and long recovery period, and is not suitable for high-risk operation groups such as elderly patients and patients with complications. The catheter-mediated treatment has small trauma and quick recovery, and is more and more accepted by doctors and patients. Transcatheter mitral valve replacement provides a new option for patients who are not suitable for open surgery by placing a valve prosthesis in an interventional manner to replace the function of the native mitral valve. However, due to the complex anatomical features of the human mitral valve, mitral valve replacement still has many problems to be solved, such as hemodynamic disturbance after implantation of a valve prosthesis, thrombus formation, etc.

SUMMERY OF THE UTILITY MODEL

The utility model discloses aim at solving one of the technical problem that exists among the prior art at least. Therefore, an object of the present invention is to provide a valve prosthesis, which can reduce the risk of blood accumulating between the first stent and the second stent to form thrombus, and can avoid blood backflow.

A valve prosthesis according to an embodiment of the present invention comprises: the valve support comprises a first support and a second support which are sequentially arranged from inside to outside, the diaphragm comprises a first diaphragm and a second diaphragm, the first diaphragm is arranged on the inner circumferential surface and/or the outer circumferential surface of the first support, and the second diaphragm is arranged on the outer circumferential surface and/or the inner circumferential surface of the second support. The leaflets are disposed within the first stent, the one-way conduction device is disposed between the first stent and the second stent, the one-way conduction device is configured to open to allow fluid between the first stent and the second stent to flow out when the leaflets are open and to close when the leaflets are closed.

According to the utility model discloses valve prosthesis through setting up the one-way device that switches on, can realize the blood unidirectional flow between first support circumference direction, the second support circumference direction, can avoid blood to pile up in the clearance between the circumference direction of first support and second support, prevent to form the thrombus, avoid blood against the current simultaneously, reduce the number of times for remedying this part blood heart against the current is pulsating, reduce the condition such as the cardiac muscle hypertrophy that probably appears, pulmonary artery high pressure, atrial fibrillation and heart failure.

In some embodiments, the unidirectional conducting device comprises: and one end of the flanging is connected with the end part of one of the first diaphragm and the second diaphragm, and the other end of the flanging extends towards the direction of the other one of the first diaphragm and the second diaphragm. The other end of the cuff is spaced apart from an end of the other of the first and second diaphragms when the leaflets are open, and the other end of the cuff abuts an end of the other of the first and second diaphragms when the leaflets are closed.

In some embodiments, the unidirectional conducting device further comprises: at least one elastic structure, the elastic structure is connected between the valve support and the flanging, and the elastic structure always pulls the flanging towards the direction far away from the flanging.

In some embodiments, the valve support is provided with at least one connecting rod extending towards the flange, the connecting rod is formed with a first through hole, and one end of the elastic structure far away from the flange is matched with the first through hole.

In some embodiments, the other end of the flange is provided with a supporting frame, a second through hole is formed in the supporting frame, and one end of the elastic structure, which is adjacent to the flange, is fitted in the second through hole.

In some embodiments, the support frame is a memory metal member.

In some embodiments, the septum further comprises a third septum coupled between the first septum and the second septum, the third septum having at least one opening formed therein. The unidirectional flux device includes: the blocking piece is arranged at the opening to open and close the opening, the blocking piece opens the opening when the valve blades are opened, and the blocking piece closes the opening when the valve blades are closed.

In some embodiments, a portion of an edge of the flap is connected to the third diaphragm, another portion of the edge of the flap is spaced apart from the third diaphragm when the leaflets are open, and another portion of the edge of the flap is in contact with the third diaphragm to close the opening when the leaflets are closed.

In some embodiments, one end of the flap is pivotally connected to the third diaphragm, and the other end of the flap is pivotable about the one end of the flap to open and close the opening.

In some embodiments, the flap has an area greater than an area of the opening.

Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.

Drawings

The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:

fig. 1 is a schematic view of a valve prosthesis closed according to an embodiment of the present invention.

Fig. 2 is a schematic view of the structure section of the turn-ups closing according to the embodiment of the present invention.

Fig. 3 is a schematic view of a valve prosthesis opening according to an embodiment of the present invention.

Fig. 4 is a schematic sectional view of a structure in which a turn-up is opened according to an embodiment of the present invention.

Fig. 5 is a schematic view of the cooperation of the first membrane, the flange and the support rim according to an embodiment of the present invention.

Fig. 6 is a schematic structural view of a valve stent according to an embodiment of the present invention.

Fig. 7 is an enlarged view of portion P in fig. 6.

Fig. 8 is a schematic cross-sectional view of the elastic structure when the flange is closed according to an embodiment of the present invention.

Fig. 9 is a schematic cross-sectional view of an elastic structure when the cuff is opened according to an embodiment of the present invention.

Fig. 10 is a schematic diagram of the cooperation of the spring, the connecting rod and the flange according to the embodiment of the present invention.

Fig. 11 is a schematic view of the elastic structure, the connecting rod and the flange according to the embodiment of the present invention.

Fig. 12 is a schematic cross-sectional view of a septum according to an embodiment of the invention.

Fig. 13 is a schematic view of a third diaphragm cooperating with a baffle according to an embodiment of the present invention.

Fig. 14 is a schematic view of a third membrane in cooperation with a baffle according to another embodiment of the present invention.

Reference numerals:

a valve prosthesis 100;

a valve stent 10; a first bracket 11; a second bracket 12; a connecting rod 13; a first through hole 131;

a diaphragm 20; a first diaphragm 21; a second septum 22; a third diaphragm 23; an opening 231;

a leaflet 30; a flanging 40; a support frame 41; a second through hole 411;

an elastic structure 50; a baffle 60; a one-way conduction device 70; a connecting member 80.

Detailed Description

Embodiments of the present invention are described in detail below, the embodiments described with reference to the drawings being exemplary, and a valve prosthesis 100 according to embodiments of the present invention is described below with reference to fig. 1-14.

The valve prosthesis 100 according to the embodiment of the present invention includes: valve support 10, septum 20, valve leaflets 30, and one-way conduction device 70.

The valve prosthesis 100 may be used to replace native valve structures such as mitral valve, tricuspid valve, aortic valve, and pulmonary valve, and the replacement of the mitral valve by the valve prosthesis 100 is described as an example, but does not represent a limitation thereto.

Specifically, as shown in fig. 1 to 4, the valve holder 10 includes a first holder 11 and a second holder 12 which are sequentially disposed from inside to outside, and the diaphragm 20 includes a first diaphragm 21 and a second diaphragm 22, the first diaphragm 21 being disposed on an inner circumferential surface and/or an outer circumferential surface of the first holder 11, and the second diaphragm 22 being disposed on an inner circumferential surface and/or an outer circumferential surface of the second holder 12. The leaflets 30 are disposed within the first stent 11 through the first membrane 21, the one-way conduction device 70 is disposed between the first stent 11 and the second stent 12, the one-way conduction device 70 is configured such that the one-way conduction device 70 opens to allow fluid between the first stent 11 and the second stent 12 to flow out when the leaflets 30 are open, and the one-way conduction device 70 closes when the leaflets 30 are closed. Here, "fluid" may refer to blood of a human body.

For example, the valve leaflet 30 may replace a native mitral valve when the valve prosthesis 100 is disposed between the left atrium and the left ventricle, when the left ventricle is relaxed, the flow direction of blood is from the left atrium to the left ventricle, at this time, the valve leaflet 30 of the valve prosthesis 100 is opened, the one-way conduction device 70 is opened, most of the blood may flow into the left ventricle through the opened valve leaflet 30, and another part of the blood flowing between the first stent 11 and the second stent 12 may flow into the left ventricle from the left atrium through the one-way conduction device 70, and the one-way conduction device 70 may be disposed to prevent the blood from pooling or forming a vortex between the first stent 11 and the second stent 12, which may cause a thrombus due to poor blood circulation. When the left ventricle contracts, blood flows from the left ventricle into the aorta, the valve leaflets 30 of the valve prosthesis 100 are pressed closed, and the one-way conduction device 70 is also pressed closed to prevent backflow of blood to the left atrium.

The first bracket 11 and the second bracket 12 are connected to each other, for example, the bottom end of the first bracket 11 is bent outward to be connected to the bottom end of the second bracket 12, so that an inner and outer double-layered bracket is formed through the bending at the connection, and the first bracket 11 is located at the inner side of the second bracket 12. The first diaphragm 21 is disposed on the inner circumferential surface and/or the outer circumferential surface of the first support 11, that is, the first diaphragm 21 is disposed on one of the inner circumferential surface and the outer circumferential surface of the first support 11, or the first diaphragm 21 is disposed on both the inner circumferential surface and the outer circumferential surface of the first support 11. For example, the first diaphragm 21 is disposed on the inner peripheral surface of the first holder 11, that is, the first diaphragm 21 is connected to the side of the first holder 11 away from the second holder 12. The second diaphragm 22 is disposed on the inner circumferential surface and/or the outer circumferential surface of the second support 12, that is, the second diaphragm 22 is disposed on one of the inner circumferential surface and the outer circumferential surface of the second support 12, or the first diaphragm 21 is disposed on both the inner circumferential surface and the outer circumferential surface of the second support 12. For example, the second diaphragm 22 is provided on the outer peripheral surface of the second holder 12, that is, the second diaphragm 22 is provided on the side of the second holder 12 away from the first holder 11. The first and second diaphragms 21 and 22 may be fixed to the first and second brackets 11 and 12, respectively, by sewing. A leaflet 30 is disposed within the first stent 11. A one-way conduction device 70 is arranged between the first support 11 and the second support 12, and a channel formed after the one-way conduction device 70 is opened is positioned at the outer periphery side of the channel formed after the valve leaflet 30 is opened. When the valve leaflets 30 are opened, the one-way conduction device 70 is also opened, and the fluid between the first stent 11 and the second stent 12 flows in one direction.

The first support 11 is used for installing and fixing the valve leaflets 30 through the first membrane 21, and the first support 11 can provide support for the valve leaflets 30 and the first membrane 21. The leaflets 30 are used to replace the native valve, e.g., the mitral valve. The first membrane 21 may act as a seal in the circumferential direction of the first frame 11 and facilitate a suture connection with the leaflets 30 such that the leaflets 30 are secured within the first frame 11.

The second frame 12 may rest against the atrial wall of the atrium, the second frame 12 may provide support for a second membrane 22, the second membrane 22 may be sutured to the second frame 12, the second membrane 22 may act as a seal in the circumferential direction of the second frame 12, and the second membrane 22 attached to the second frame 12 may bring the valvular prosthesis 100 into close contact with the atrial wall of the atrium preventing fluid flow through the gap between the valvular prosthesis 100 and the atrial wall of the atrium.

From this, through setting up one-way device 70 that switches on, can realize the blood unidirectional flow between first support 11 circumferential direction, second support 12 circumferential direction, can avoid blood to pile up at the clearance between the circumferential direction of first support 11 and the circumferential direction of second support 12, prevent to form the thrombus, avoid blood adverse current simultaneously, reduce to compensate the number of times of blood heart beat of this part adverse current, reduce the condition such as cardiac muscle hypertrophy, pulmonary artery high pressure, atrial fibrillation and heart failure that probably appear.

In some embodiments, as shown in fig. 6, the first holder 11 has a cylindrical shape, and the second holder 12 has a spherical upper portion and a cylindrical lower portion. The first diaphragm 21 is disposed on the first support 11 and is adapted to the shape of the first support 11. The second diaphragm 22 is disposed on the second support 12 to conform to the shape of the second support 12. In addition, the top of the second bracket 12 is provided with a connector 80 to connect the bracket bar of the second bracket 12.

In some embodiments, as shown in fig. 2 and 4, the one-way communication device 70 includes a flange 40, one end of the flange 40 is connected to an end of one of the first and second diaphragms 21 and 22, and the other end of the flange 40 extends toward the other of the first and second diaphragms 21 and 22. When the leaflets 30 are open, the other end of the cuff 40 and the end of the other of the first and second diaphragms 21, 22 are spaced apart from each other; when the leaflets 30 are closed, the other end of the cuff 40 abuts the end of the other of the first and second diaphragms 21, 22.

One end of the cuff 40 may be connected to one of the first and second diaphragms 21, 22 and to an end of the first or second diaphragm 21, 22. For example, one end of the cuff 40 may be attached to the end of the first diaphragm 21, and the other end of the cuff 40 is a free end. When the valve leaflets 30 are open, the free end of the cuff 40 can move away from the end of the second diaphragm 22 under the pressure of the fluid, enabling the flow of fluid between the first stent 11 and the second stent 12, avoiding accumulation between the first stent 11 and the second stent 12; when the leaflets 30 close, the free end of the cuff 40, i.e. the end of the cuff 40 remote from the first diaphragm 21, and the end of the second diaphragm 22, come to rest against each other due to the reduction of the fluid pressure, creating a closure between the first support 11 and the second support 12, avoiding the backflow of fluid from between the first support 11 and the second support 12.

Therefore, by arranging the flanging 40 at one end part of the first diaphragm 21 and the second diaphragm 22, when the valve leaflets 30 are opened, the free end of the flanging 40 moves to enable fluid between the first support 11 and the second support 12 to flow out, so that thrombus formation caused by accumulation is avoided, and meanwhile, when the valve leaflets 30 are closed, the free end of the flanging 40 can be tightly attached to the end part of the other one of the first diaphragm 21 and the second diaphragm 22 to form a seal between the first support 11 and the second support 12, so that the load of the heart caused by the reverse flow of the fluid is avoided.

In some embodiments, the end face of the other end of the cuff 40 extends beyond a side surface of the other of the first diaphragm 21 and the second diaphragm 22 that is distal from the one of the first diaphragm 21 and the second diaphragm 22. It can be understood that, taking the case that the flange 40 is disposed on the first diaphragm 21 as an example, one end of the flange 40 (i.e. the other end of the flange 40) far away from the first diaphragm 21 exceeds one side of the second diaphragm 22 far away from the first diaphragm 21, i.e. the outer diameter of the flange 40 is larger than the outer diameter of the end of the second diaphragm 22, and when the end of the flange 40 far away from the first diaphragm 21 contacts the end of the second diaphragm 22 to form a one-way passage, and is closed, the flange 40 can completely close the space between the first diaphragm 21 and the second diaphragm 22, i.e. effectively close the gap between the first support 11 and the second support 12, thereby effectively avoiding the reverse flow of fluid.

In some embodiments, as shown in fig. 8-11, the unidirectional conducting device 70 further comprises: at least one elastic structure 50, the elastic structure 50 being connected between the valve support 10 and the cuff 40, the elastic structure 50 normally pulling the cuff 40 away from the cuff 40.

The flange 40 has a closed position and an open position. For example, when one end of the cuff 40 is connected to the end of the first diaphragm 21, the other end of the cuff 40 is in contact with the end of the second diaphragm 22 in a closed position and the end remote from the second diaphragm 22 is in an open position. In order to facilitate the smooth movement of the flap 40 between the open position and the closed position, a resilient structure 50 is provided between the flap 40 and the valve support 10. When the blood between the first bracket 11 and the second bracket 12 is more, the pressure applied to the flange 40 is larger, the flange 40 moves from the closed position to the open position, the elastic structure 50 is stretched, after the blood between the first bracket 11 and the second bracket 12 flows into the left ventricle, the pressure applied to the flange 40 is reduced, and at the moment, the elastic structure 50 drives the flange 40 to return to the closed position from the open position by utilizing the self-restoring capability. From this, elastic construction 50's setting can be convenient for drive the turn-ups 40 motion, for turn-ups 40 provides the power of closing, and the simple structure of one-way conduction device 70 can effectively reduce piling up of blood between first support 11 and the second support 12.

In some embodiments, as shown in fig. 6 and 7, at least one connecting rod 13 extending towards the flange 40 is provided on the valve support 10, a first through hole 131 is formed on the connecting rod 13, and an end of the elastic structure 50 away from the flange 40 is fitted at the first through hole 131.

For example, at least one connecting rod 13 may be disposed on the second bracket 12 corresponding to the free end of the flange 40, one end of the connecting rod 13 is fixed to the second bracket 12, the other end of the connecting rod 13 overhangs toward the flange 40, and a certain gap is left between the connecting rod 13 and the flange 40, so as to mount the elastic structure 50 on the overhanging end of the connecting rod 13. The overhanging end of the connecting rod 13 may be provided with a first through hole 131 for connecting one end of the elastic structure 50, and the other end of the elastic structure 50 is connected with the flange 40.

Therefore, the connecting rod 13 is arranged on the valve support 10, and the first through hole 131 is formed in one end, close to the flange 40, of the connecting rod 13, so that the elastic structure 50 is conveniently connected with the valve support 10, and the convenience and the reliability of connection between the elastic structure 50 and the valve support 10 are improved.

In some embodiments, as shown in fig. 5, the other end of the flange 40, i.e. the free end of the flange 40, is provided with a supporting frame 41, the supporting frame 41 is formed with a second through hole 411, and one end of the elastic structure 50 adjacent to the flange 40 is fitted at the second through hole 411.

For example, a support frame 41 is disposed at an end of the flange 40 away from the first membrane 21, the support frame 41 is located at an outer edge of the end of the flange 40 away from the first membrane 21, and the flange 40 and the support frame 41 are fixedly connected by sewing, bonding, or welding. The outer diameter of the support frame 41 is larger than the outer diameter of the bottom end of the second frame 12, so that when the flange 40 is in the closed position, the sealing effect on the gap between the first frame 11 and the second frame 12 can be ensured, and the blood can be prevented from flowing backwards. The supporting frame 42 is provided with a plurality of second through holes 411 at positions opposite to the plurality of first through holes 131, and when the elastic structure 50 is connected to the valve stent 10 and the flange 40, one end of the elastic structure is connected to the first through holes 131, and the other end of the elastic structure is connected to the second through holes 411. From this, be equipped with second through-hole 411 on the support frame 41 to elastic construction 50 and the adaptation of second through-hole 411 increase the fastness that elastic construction 50 and turn-ups 40 are connected, and the mode of connection is simple, reduces the installation degree of difficulty of valvular prosthesis 100.

In addition, the supporting frame 41 is arranged, so that the strength of the structure of one end, away from the first diaphragm 21, of the flanging 40 can be increased, and the situation that the flanging 40 between the first diaphragm 21 and the second diaphragm 22 is not closed tightly due to deformation of the flanging 40 to generate backflow is avoided.

In some embodiments, the support frame 41 is a memory metal member. The memory metal is a special metal material which can restore the original macroscopic shape in another temperature range after plastic deformation in a certain temperature range, the support frame 41 made of the memory metal can keep a compressed shape for a long time so as to facilitate the implantation of the valve prosthesis 100, and can form an expanded shape under the action of the internal temperature after the implantation is finished so as to realize the function of supporting the flanging 40.

In some embodiments, as shown in fig. 8-10, the elastic structure 50 is a bungee cord or spring. That is, the elastic structure 50 may be a part having elastic restorability, and one end of a bungee cord or a spring may be connected with the first through hole 131 and the other end thereof is connected with the second through hole 411. Therefore, the shape of the elastic structure 50 is not limited, the cuff 40 can move between the closed position and the open position under the action of the elastic structure 50, and the structure of the elastic structure 50 is simple, which is beneficial to reducing the manufacturing cost. The elastic cord may be connected to the first through hole 131 and the second through hole 411 by sewing or fastening. The spring may be connected to the first and second through holes 131 and 411 by sewing, welding, or screwing.

In some embodiments, the resilient structure 50 is part of the valve stent 10, i.e., the resilient structure 50 can be manufactured and formed with the valve stent 10 by an integral molding technique. The production and processing procedures are reduced, and the production efficiency and the overall structural strength of the valve prosthesis 100 are improved.

As shown in fig. 11, the connecting rod 13 is partially bent in an S-shaped configuration in a direction overhanging the cuff 40 to form the elastic structure 50. The elastic structure 50 is an elastic component, and is not limited in particular, and a structure having elasticity like an S-shape or a spiral shape should be considered within the scope of protection.

In some embodiments, the elastic structure 50 is plural, for example, the number of the elastic structures 50 may be 2 to 12, and the plural elastic structures 50 are spaced apart along the circumference of the first diaphragm 21. Thus, the provision of a plurality of resilient structures 50 helps to increase the reliability of the attachment of the valve stent 10 to the cuff 40, facilitating the closing and opening of the cuff 40 to even out the forces on the cuff 40.

In some embodiments, as shown in figures 12 and 13, the diaphragm 20 further includes a third diaphragm 23, the third diaphragm 23 coupled between the first diaphragm 21 and the second diaphragm 22, the third diaphragm 23 having at least one opening 231 formed therein. The unidirectional flux device 70 includes: at least one flap 60, the flap 60 being provided at the opening 231 to open and close the opening 231, the flap 60 opening the opening 231 when the leaflets 30 are open, and the flap 60 closing the opening 231 when the leaflets 30 are closed.

The third diaphragm 23 is provided with openings 231, and the number of the openings 231 may be determined according to the use environment, for example, the number of the openings 231 is 2-12, and the openings are uniformly spaced along the circumferential direction of the third diaphragm 23. A stop 60 is provided on the side of the third membrane 23 remote from the valve holder 10 opposite the opening 231, i.e. a stop 60 is provided on the lower surface of the third membrane 23 opposite the opening 231. The number of the flaps 60 corresponds one-to-one to the openings 231. The first diaphragm 21, the second diaphragm 22 and the third diaphragm 23 may be integrated with each other. The flap 60 can fit over the third membrane 23 to form a seal against the opening 231 when the leaflets 30 are closed, and the flap 60 moves downward under fluid pressure to form a fluid flow path when the leaflets 30 are open.

Therefore, by arranging the third diaphragm 23 and providing the opening 231 and the baffle 60 adapted to the opening 231 on the third diaphragm 23, the structural strength of the connection between the first diaphragm 21 and the second diaphragm 22 is improved, the first diaphragm 21 and the second diaphragm 22 are integrally formed conveniently, the process flow of processing the first diaphragm 21 and the second diaphragm 22 is reduced, and the sealing property between the first diaphragm 21 and the second diaphragm 22 is improved.

In some embodiments, as shown in fig. 13, a portion of the edge of flap 60 is attached to third membrane 23 by, for example, stitching. Another part of the edge of the flap 60 and the third diaphragm 23 are spaced apart from each other when the leaflets 30 are open, and another part of the edge of the flap 60 and the third diaphragm 23 are in contact to close the opening 231 when the leaflets 30 are closed.

Part of the edge of the flap 60 is connected to the third diaphragm 23 in the circumferential direction of the opening 231, part of the edge is not connected to the third diaphragm 23, and when the leaflet 30 is opened, the edge of the flap 60 that is not connected to the third diaphragm 23 by the fluid pressure forms a flow channel so that the fluid between the first stent 11 and the second stent 12 can smoothly flow away. The flap 60 has a restoring capability, and when the valve leaflets 30 are closed, the flap 60 can contact the third membrane 23 to form a closure of the opening 231, preventing fluid from flowing back.

In some embodiments, as shown in fig. 14, one end of the flap 60 is pivotally connected to the third diaphragm 23, and the other end of the flap 60 is pivotable about one end of the flap 60 to open and close the opening 231. I.e. one side of the flap 60 is pivotally connected relative to the third membrane 23, the other side of the flap 60 is moved away from the third membrane 23 when the leaflets 30 are open. The pivoting member connecting the flap 60 and the third diaphragm 23 may be a torsion spring or the like. When the valve leaflets 30 close, the pivoting member brings the flap 60 into contact with the third diaphragm 23 gradually under its own elastic force to close the opening 231. The blocking piece 60 can be installed in a frame formed by memory metal, the rigidity of the memory metal is utilized to facilitate the arrangement of a pivoting member to realize the pivoting connection with the third diaphragm 23, and the blocking piece 60 is supported conveniently, so that the blocking piece 60 is prevented from being distorted and deformed. Thus, one end of the flap 60 is pivotally connected to the third membrane 23 and the other end is pivotally opened and closed, increasing the manner in which the flap 60 is connected to the third membrane 23 to accommodate different environments, increasing the versatility and versatility of the solution of the valve prosthesis 100.

Optionally, the area of the flap 60 is larger than the area of the opening 231, so as to facilitate the contact between the flap 60 and the third diaphragm 23 when the valve leaflet 30 is closed, so as to better close the opening 231 and avoid the backflow of the fluid.

In some embodiments, the shape of the opening 231 is circular, elliptical, semicircular, semi-elliptical, or polygonal. The shape of the opening 231 is not limited, so that the valve prosthesis 100 can select a proper opening 231 to meet the requirements of use according to different actual use scenes.

In some embodiments, the baffle 60 is a piece of biological tissue or polymer material, such as a piece of bovine pericardium or a piece of PET (Polyethylene terephthalate), so that the baffle 60 is closer to the environment of use, has good adaptability, and reduces rejection when the valve prosthesis 100 is implanted into a human body.

With reference to fig. 1 to 14, by providing the first stent 11 and the second stent 12 in the valvular prosthesis 100, and the first membrane 21 attached to the inner circumferential surface and/or the outer circumferential surface of the first stent 11 and the second membrane 22 attached to the inner circumferential surface and/or the outer circumferential surface of the second stent 12, the leaflet 30 is provided in the first stent 11 and can be attached to the first membrane 21 by sewing, and the second membrane 22 can be stopped against the atrial wall of the atrium, thereby avoiding the uncertainty of the flow direction of the fluid on the valvular stent 10 and avoiding the fluid from flowing from the gap between the valvular prosthesis 100 and the atrial wall.

The one-way conduction device 70 is formed between the first support 11 and the second support 12, and the one-way conduction device 70 comprises a flange 40 with one end connected with one of the first diaphragm 21 or the second diaphragm 22, or a third diaphragm 23 which simultaneously connects the first diaphragm 21 and the second diaphragm 22. When the one-way conduction device 70 includes the burring 40, the burring 40 can be opened and closed. When the one-way conduction device 70 includes the third diaphragm 23, an opening 231 may be provided on the third diaphragm 23, and a flap 60 is provided on the third diaphragm 23 so as to be opposite to the opening 231, and the flap 60 can close and open the opening 231. The flanging 40 has similar functions with the baffle 60, and can avoid the accumulation of blood between the first support 11 and the second support 12, effectively dredge the accumulated blood, so as to avoid the formation of thrombus, and effectively prevent the occurrence of adverse current, and the conditions of heart failure, myocardial hypertrophy and the like caused by the frequent beating of the heart due to insufficient blood stored in the ventricle are caused.

Therefore, the valve prosthesis 100 of the present invention can effectively avoid the accumulation of blood in the valve holder 10, reduce the risk of thrombus formation, and avoid the unnecessary burden of the relevant body caused by the blood flowing from the ventricle to the atrium, thereby maintaining the life health of the human body.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", and the like, indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for convenience of description and simplicity of description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore, should not be construed as limiting the present invention.

In the description of the present invention, "the first feature" and "the second feature" may include one or more of the features. In the description of the present invention, "a plurality" means two or more. In the description of the present invention, the first feature being "on" or "under" the second feature may include the first and second features being in direct contact, and may also include the first and second features not being in direct contact but being in contact via another feature therebetween. In the description of the invention, the first feature being "on", "above" and "above" the second feature includes the first feature being directly above and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an illustrative embodiment," "an example," "a specific example," or "some examples" or the like mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example.

While embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that: various changes, modifications, substitutions and alterations can be made to the embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims (10)

1. A valve prosthesis, comprising:

the valve support comprises a first support and a second support which are arranged from inside to outside in sequence;

the diaphragm comprises a first diaphragm and a second diaphragm, the first diaphragm is arranged on the inner circumferential surface and/or the outer circumferential surface of the first support, and the second diaphragm is arranged on the inner circumferential surface and/or the outer circumferential surface of the second support;

a leaflet disposed within the first stent;

a one-way conduction device disposed between the first stent and the second stent, the one-way conduction device configured to open to allow fluid between the first stent and the second stent to flow out when the leaflets are open and to close when the leaflets are closed.

2. The valve prosthesis of claim 1, wherein the one-way conduction means comprises:

a flange, one end of which is connected to an end of one of the first diaphragm and the second diaphragm, and the other end of which extends toward the other of the first diaphragm and the second diaphragm;

the other end of the cuff is spaced apart from an end of the other of the first and second diaphragms when the leaflets are open, and the other end of the cuff abuts an end of the other of the first and second diaphragms when the leaflets are closed.

3. The valve prosthesis of claim 2, wherein the one-way conduction means further comprises:

at least one elastic structure, the elastic structure is connected between the valve support and the flanging, and the elastic structure always pulls the flanging towards the direction far away from the flanging.

4. The valve prosthesis of claim 3, wherein the valve support is provided with at least one connecting rod extending towards the flange, the connecting rod is formed with a first through hole, and one end of the elastic structure far away from the flange is matched with the first through hole.

5. The valve prosthesis of claim 3 or 4, wherein the other end of the cuff is provided with a support frame, a second through hole is formed in the support frame, and one end of the elastic structure adjacent to the cuff is fitted in the second through hole.

6. The valve prosthesis of claim 5, wherein the support frame is a memory metal piece.

7. The valve prosthesis of claim 1, wherein the septum further comprises a third septum coupled between the first septum and the second septum, the third septum having at least one opening formed therein;

the unidirectional flux device includes:

the blocking piece is arranged at the opening to open and close the opening, the blocking piece opens the opening when the valve blades are opened, and the blocking piece closes the opening when the valve blades are closed.

8. The valve prosthesis of claim 7, wherein a portion of an edge of the flap is connected to the third membrane;

another partial edge of the flap and the third diaphragm are spaced apart from each other when the valve leaflets are open, and another partial edge of the flap is in contact with the third diaphragm to close the opening when the valve leaflets are closed.

9. The valve prosthesis of claim 7, wherein one end of the flap is pivotally connected to the third membrane, and the other end of the flap is pivotable about the one end of the flap to open and close the opening.

10. The valve prosthesis of claim 7, wherein an area of the flap is greater than an area of the opening.

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