Heart mitral valve replacement device

Abstract

The invention relates to the technical field of medical instruments, and discloses a heart mitral valve replacement device which comprises a first covering film, and the surface of one end of the first covering film is connected with a left atrial side positioning piece. The left atrial side positioning piece is tightly attached to a mitral valve ring, the atrial side positioning piece and the lower edges of valve leaflets form clamping force through chordae tendineae, the displacement phenomenon of the valve in the heartbeat process is effectively avoided, the success rate of the valve replacement operation is greatly increased, the displacement risk is reduced, the three-leaf valve is opened and closed in the shape of three valve leaflets, and the valve replacement efficiency is improved. In the blood flowing process, the valve leaflets can be smoothly opened and closed, blood flow resistance is reduced, blood backflow is avoided, recovery and maintenance of heart functions are facilitated, and the valve can be conveniently stored in a conveying device in the implanting process due to the compressible deformation and shape memory functions of the nickel-titanium alloy net and the ventricular side positioning piece; and accurate release is realized after the target position is reached, so that the surgical operation is simpler and more convenient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a cardiac mitral valve replacement device. Background Art

[0002] The cardiac mitral valve plays a crucial role in the human blood circulation system. It is located between the left atrium and the left ventricle and acts like a one-way valve, precisely controlling the direction of blood flow. During each heartbeat of the heart, when the left atrium contracts, the mitral valve opens, allowing blood to flow smoothly from the left atrium into the left ventricle. When the left ventricle relaxes, the mitral valve quickly closes, effectively preventing blood from flowing back into the left atrium. This precise opening and closing mechanism ensures the efficiency and stability of cardiac blood circulation, providing sufficient oxygen and nutrients to all tissues and organs throughout the body. Multiple factors can cause the mitral valve to malfunction. When the mitral valve has severe lesions, valve replacement surgery is an important treatment method. Therefore, there is a particular need for a cardiac mitral valve replacement device.

[0003] However, existing cardiac mitral valve replacement mechanisms are prone to displacement in the environment of cardiac beating and blood flow, which affects the valve function. The operation during surgical implantation is complex, the valve is prone to deformation during the delivery process, and the position is inaccurate during release. Summary of the Invention

[0004] (I) Technical Problems to be Solved

[0005] In view of the deficiencies of the prior art, the present invention provides a cardiac mitral valve replacement device, which solves the problems of being prone to displacement in the environment of cardiac beating and blood flow, complex operation during surgical implantation, easy deformation during the delivery process, and inaccurate position during release.

[0006] (II) Technical Solutions

[0007] To achieve the above object, the present invention provides the following technical solution: A cardiac mitral valve replacement device includes a first membrane. The inner surface of the first membrane is fixedly connected with a nitinol mesh. The inner surface of the nitinol mesh is fixedly connected with a three-leaf valve. The outer surface of the first membrane is fixedly connected with a ventricular side positioning member. One side surface of the ventricular side positioning member is fixedly connected with barbs. One end surface of the first membrane is connected with a left atrium side positioning member.

[0008] Preferably, the nitinol mesh is integrally formed and is a shape memory metal that can be compressed and deformed.

[0009] Preferably, the left atrium side positioning member is a shape memory metal that can be compressed and deformed. When unfolded, the left atrium side positioning member is semicircular. When compressed, it can be received into the delivery device. The outer ring of the left atrium side positioning member can closely abut against the mitral valve annulus when unfolded.

[0010] Preferably, a diamond-shaped mesh structure is provided on the upper surface of the left atrial side positioning member.

[0011] Preferably, multiple groups of barbs are provided on one surface of the ventricular side positioning member. Multiple groups are provided on the outer surface of the first membrane of the ventricular side positioning member, and the ventricular side positioning member corresponds to the left atrial side positioning member.

[0012] Preferably, the nitinol mesh, the three-lobe valve, and the first membrane form a valve body.

[0013] Preferably, both the ventricular side positioning member and the left atrial side positioning member are made of materials with shape memory functions, and the materials are nitinol or cobalt-chromium.

[0014] Preferably, the three-lobe valve is composed of biological materials, and the valve leaflets of the three-lobe valve are semi-circular.

[0015] Preferably, the ventricular side positioning member can pass through the chordae tendineae and abut against the lower edge of the mitral valve leaflet to form a stable clamping force with the left atrial side positioning member.

[0016] Preferably, the ventricular side positioning member has elasticity, and a second membrane is provided on the surfaces of the ventricular side positioning member and the left atrial side positioning member.

[0017] (III) Beneficial Effects

[0018] Compared with the prior art, the present invention provides a cardiac mitral valve replacement device, which has the following beneficial effects:

[0019] 1. For this cardiac mitral valve replacement mechanism, the coordinated work of the left atrial side positioning member and the ventricular side positioning member realizes the precise positioning and stable fixation of the valve at the mitral position. The left atrial side positioning member closely adheres to the mitral valve annulus, and the ventricular side positioning member forms a clamping force with the lower edge of the valve leaflet through the chordae tendineae, effectively avoiding the displacement of the valve during the heartbeat process, greatly improving the success rate of valve replacement surgery, and reducing the displacement risk.

[0020] 2. For this cardiac mitral valve replacement mechanism, the three-lobe valve opens and closes in the shape of three valve leaflets. During blood flow, the valve leaflets can open and close smoothly, reducing blood flow resistance, avoiding blood backflow, and being beneficial to the recovery and maintenance of cardiac function.

[0021] 3. For this cardiac mitral valve replacement mechanism, the compressible deformation and shape memory functions of the nitinol mesh and the ventricular side positioning member enable the valve to be conveniently accommodated in the delivery device during implantation and accurately released after reaching the target position, making the surgical operation more convenient. Description of the Drawings

[0022] Figure 1Schematic diagram of the overall structure of a mitral valve replacement device proposed by the present invention;

[0023] Figure 2 Connection diagram of the three - leaf valve and the first film of a mitral valve replacement device proposed by the present invention;

[0024] Figure 3 Schematic diagram of the cooperating structure between the first film and the ventricular - side positioning member of a mitral valve replacement device proposed by the present invention;

[0025] Figure 4 Schematic diagram of the cooperating structure between the ventricular - side positioning member and the barb of a mitral valve replacement device proposed by the present invention;

[0026] Figure 5 Schematic diagram of the cooperating structure between the three - leaf valve and the nitinol mesh of a mitral valve replacement device proposed by the present invention;

[0027] Figure 6 Schematic diagram of the nitinol mesh structure of a mitral valve replacement device proposed by the present invention.

[0028] In the figure: 1. First film; 2. Nitinol mesh; 3. Three - leaf valve; 4. Ventricular - side positioning member; 5. Barb; 6. Left - atrium - side positioning member. Detailed implementation manners

[0029] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0030] Please refer to Figure 1-6 , the present invention provides a technical solution: a mitral valve replacement device, including a first film 1, a nitinol mesh 2 is fixedly connected to the inner surface of the first film 1, a three - leaf valve 3 is fixedly connected to the inner surface of the nitinol mesh 2, a ventricular - side positioning member 4 is fixedly connected to the outer surface of the first film 1, a barb 5 is fixedly connected to one side surface of the ventricular - side positioning member 4, and a left - atrium - side positioning member 6 is connected to one end surface of the first film 1.

[0031] Furthermore, the nitinol mesh 2 is integrally formed. The nitinol mesh 2 is a shape memory metal and can be compressed and deformed. With the above structure, during use, before the valve implantation, by utilizing the compressible and deformable characteristics of the nitinol mesh 2, the nitinol mesh 2 is compressed and stored in the delivery device, facilitating the delivery of the valve to the mitral valve position of the heart through instruments such as catheters. After reaching the target position, the nitinol mesh 2 restores its original shape by virtue of the characteristics of the shape memory metal, providing a stable support structure for the valve, maintaining the shape of the valve, and ensuring that components such as the trileaflet valve 3 can function properly. The characteristics of integral formation and shape memory metal make the valve delivery process more convenient, reducing the difficulty and risk of surgical operations. At the same time, the stable support structure ensures the stability of the valve during long-term use, helping to extend the service life of the valve and reducing functional abnormalities caused by unstable valve structures.

[0032] Furthermore, the left atrial side positioning member is a shape memory metal and can be compressed and deformed. When the left atrial side positioning member is deployed, it is semicircular. When compressed, it can be received into the delivery device. When the left atrial side positioning member is deployed, its outer ring can closely abut against the mitral valve annulus. With the above structure, during use, during the valve implantation surgery, after the left atrial side positioning member 6 reaches the mitral valve position with the delivery device and unfolds, the semicircular outer ring of the left atrial side positioning member 6 closely fits with the mitral valve annulus. Relying on the friction force and the degree of fit generated by this close contact, the initial positioning of the valve on the atrial side is achieved, and the valve is stabilized on the atrial side of the mitral valve.

[0033] Furthermore, a diamond-shaped mesh structure is provided on the upper surface of the left atrial side positioning member 6. With the above structure, during use, after the valve is implanted, the outer ring of the left atrial side positioning member 6 closely fits with the mitral valve annulus to complete the positioning. At this time, the diamond-shaped mesh structure on the upper surface of the left atrial side positioning member 6 begins to function. This structure generates a supporting force by expanding outwards, further enhancing the connection stability between the left atrial side positioning member 6 and the valve annulus. At the same time, the left atrial side positioning member 6 is connected to the first membrane 1. Relying on this connection relationship, the left atrial side positioning member 6 can cover the atrial side leaflet of the mitral valve. During the heartbeat and blood flow, the pressure borne by the valve is dispersed, making the fixation of the valve on the atrial side more stable. The increased radial supporting force effectively improves the fixation effect of the valve on the atrial side, reduces the risk of valve displacement, ensures that the valve always remains in the correct position, and maintains the normal valve function.

[0034] Further, multiple groups of barbs 5 are provided on one side surface of the ventricular-side positioning member 4. Multiple groups of the ventricular-side positioning member 4 are provided on the outer surface of the first film 1. The ventricular-side positioning member 4 corresponds to the left atrial-side positioning member 6. With the above structure, when in use, it is optimal to set six ventricular-side positioning members 4 and two left atrial-side positioning members 6. Three ventricular-side positioning members 4 are set as a group, and each group of three cooperates with one ventricular-side positioning member 4 to clamp. When the ventricular-side positioning member 4 reaches the ventricular side of the mitral valve along with the delivery device, it passes through the chordae tendineae by virtue of its own elasticity and shape memory function. During the process of passing through the chordae tendineae, multiple groups of barbs 5 can firmly hook the chordae tendineae or surrounding tissues, preventing the ventricular-side positioning member 4 from slipping out of the chordae tendineae. Multiple groups of ventricular-side positioning members 4 cooperate with each other to fix the valve from different positions, making the fixation of the valve on the ventricular side more firm. The design of the barbs 5 and multiple groups of ventricular-side positioning members 4 significantly enhances the fixation effect of the valve on the ventricular side. This stable fixation method effectively prevents the valve from shifting during heart beating and blood flow, ensures that the valve can function stably, and reduces the occurrence of blood reflux and other situations.

[0035] Further, the nitinol mesh 2, the three-leaf valve 3, and the first film 1 constitute the valve body. With the above structure, when in use, the nitinol mesh 2 serves as the support framework of the valve body. By virtue of the integral molding and shape memory characteristics of the nitinol mesh 2, it is compressed and stored before valve implantation and resumes its original shape after reaching the target position, providing stable support for the entire valve. The three-leaf valve 3 is located inside the nitinol mesh 2 and performs opening and closing actions according to the direction and pressure change of blood flow during heart blood circulation. When blood flows from the left atrium to the left ventricle, the impact force of the blood flow causes the three-leaf valve 3 to open, allowing blood to pass through smoothly. When there is a tendency of blood backflow, the three-leaf valve 3 closes under pressure to prevent blood from flowing back. The first film 1 is wrapped on the outside. On the one hand, it protects the internal structures such as the nitinol mesh 2 and the three-leaf valve 3 from being eroded by impurities in the blood. On the other hand, the first film 1 provides a smooth surface, reducing the resistance of blood flow and ensuring that blood can pass through the valve smoothly. The valve body composed of this combination simulates the structure and function of the human own mitral valve, can effectively replace the diseased mitral valve, maintain normal heart blood circulation, the stable support structure ensures the stability of the valve during long-term use, and the good opening and closing function effectively prevents blood reflux.

[0036] Furthermore, both the ventricular-side positioning member 4 and the left-atrium-side positioning member 6 are made of materials with shape memory function. The materials are nitinol or cobalt-chromium. Through the setting of the above structure, during use, during the delivery of the valve, both the ventricular-side positioning member 4 and the left-atrium-side positioning member 6 are compressed and stored in the delivery device, and at this time their shapes change. When the delivery device reaches the mitral valve position, the ventricular-side positioning member 4 and the left-atrium-side positioning member 6 return to the preset shape by virtue of the shape memory function. After the ventricular-side positioning member 4 restores its shape, it can accurately pass through the chordae tendineae and cooperate with the left-atrium-side positioning member 6. After the left-atrium-side positioning member 6 restores its shape, the outer ring can closely abut against the mitral valve annulus, realizing the precise positioning and stable fixation of the valve.

[0037] Furthermore, the three-leaf valve 3 is composed of biological materials. The valve leaflets of the three-leaf valve 3 are semi-circular. Through the setting of the above structure, during use, the three-leaf valve 3 composed of biological materials has good biocompatibility and can reduce the rejection reaction of the human immune system to the valve. Its special design of gradually changing shape from circular to triangular is adapted to the hemodynamics of the heart. When blood flows from the left atrium to the left ventricle, the blood flow impacts the three-leaf valve 3 from the bottom circular area, causing it to gradually open and the triangular part to unfold, allowing the blood to pass smoothly. When there is a tendency of blood backflow, the triangular part quickly closes under the pressure of the backflowing blood, effectively preventing blood from flowing back. This shape change can effectively control the unidirectional flow of blood and maintain the normal blood circulation of the heart.

[0038] Furthermore, the ventricular-side positioning member 4 can pass through the chordae tendineae and abut against the lower edge of the mitral valve leaflet to form a stable clamping force with the left-atrium-side positioning member 6. Through the setting of the above structure, during use, during the valve implantation surgery, when the delivery device transports the valve to the mitral valve position of the heart, the ventricular-side positioning member 4 begins to play a role. It uses its special structure and shape memory characteristics to unfold and pass through the chordae tendineae of the mitral valve after being delivered in place. Since the chordae tendineae of the mitral valve are important structures connecting the valve leaflets and the papillary muscles and are relatively complexly distributed, the ventricular-side positioning member 4 is designed to be able to accurately pass through these chordae tendineae and stably abut against the lower edge of the mitral valve leaflet. At the same time, the left-atrium-side positioning member 6 closely adheres to the mitral valve annulus on the atrial side. In this way, the ventricular-side positioning member 4 on the ventricular side and the left-atrium-side positioning member 6 on the atrial side cooperate with each other to form a stable clamping force on the mitral valve leaflet. During the beating of the heart, regardless of whether the heart is in a systolic or diastolic state, this clamping force can effectively fix the valve in the correct position and ensure that the valve will not be displaced due to the movement of the heart and the flow of blood.

[0039] Furthermore, the ventricular side positioning member 4 is elastic, and a second coating film is provided on the surfaces of the ventricular side positioning member 4 and the left atrial side positioning member 6. With the above-described structure, during use and implantation, due to individual differences in the position and shape of the chordae tendineae, the elasticity enables the ventricular side positioning member 4 to flexibly adapt to different chordae tendineae structures, smoothly pass through the chordae tendineae without causing excessive pulling or damage to the chordae tendineae. When the heart beats, the heart tissue continuously moves and deforms. The elastic ventricular side positioning member 4 can buffer the stress changes brought about by this movement and avoid exerting excessive pressure on the surrounding tissues. In addition, the second coating film on the surfaces of the ventricular side positioning member 4 and the left atrial side positioning member 6 can reduce the frictional resistance when contacting tissues such as the chordae tendineae and valve leaflets, and reduce the wear on the tissues.

[0040] Working principle: before the valve is implanted, the compressible deformation characteristics of the nickel-titanium alloy mesh 2, the ventricular side positioning piece 4 and the left atrial side positioning piece 6 are used to compress the entire valve mechanism and store it in the delivery device, so that it can be delivered to the mitral valve position through the blood vessels through instruments such as catheters. When performing a mitral valve replacement surgery, the delivery device loaded with the valve replacement mechanism is first delivered to the interior of the ventricle through the atrial septal puncture technology. After reaching the target position, the ventricular side positioning piece 4 is first released. After the ventricular side positioning piece 4 is released, it will restore the preset shape by virtue of its shape memory function and use its own The structure allows the barbs 5 on the surface of the ventricular side positioning piece 4 to pass through the chordae tendineae of the mitral valve. The barbs 5 are tightly combined with the chordae tendineae to provide a stable support point for subsequent operations. After the ventricular side positioning piece 4 passes through the chordae tendineae, the doctor operates the delivery device to drag the ventricular side positioning piece 4 upward so that the ventricular side positioning piece 4 abuts the lower edge of the native leaflet of the mitral valve. When it is determined that the ventricular side positioning piece 4 has stably abutted the lower edge of the leaflet, the left atrial side positioning piece 6 is released. The left atrial side positioning piece 6 is semicircular, and the outer ring of the left atrial side positioning piece 6 has a good fit. After release, the outer ring of the left atrial side positioning piece 6 can closely abut the mitral valve ring, thereby The valve is positioned on the atrial side, and the left atrial positioning piece 6 cooperates with the ventricular positioning piece 4 to form a clamping trend for the mitral valve leaflets, further stabilizing the position of the valve in the heart and ensuring that the valve will not be displaced due to heart beating and blood flow. After the left atrial positioning piece 6 and the ventricular positioning piece 4 complete the positioning and preliminary clamping, the valve body in the middle is released. The nickel-titanium alloy mesh 2 is an integrally formed memory metal. It is compressed before release and returns to its original shape after release, providing a stable support frame for the entire valve. The trileaflet valve 3 is located inside the nickel-titanium alloy mesh 2 and plays a key role in the heart's blood circulation. The valve function is that when blood flows from the left atrium to the left ventricle, the impact of the blood flow will cause the tricuspid valve 3 to open, allowing blood to pass smoothly. When the blood tends to flow backward, the tricuspid valve 3 closes under pressure to prevent blood from flowing back. The first membrane 1 is wrapped around the outside, on the one hand to protect the internal structure from erosion by impurities in the blood, and on the other hand to provide a smooth surface to reduce blood flow resistance. At this point, the entire valve replacement mechanism is released and begins to work normally, replacing the diseased mitral valve, ensuring the normal blood circulation function of the heart, and solving structural diseases such as mitral stenosis and regurgitation.

[0041] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent in such process, method, article or device. Without further limitation, an element defined by the statement "comprising an..." does not exclude the existence of additional identical elements in the process, method, article or device comprising the said element.

Claims

1. A heart mitral valve replacement device, comprising a first membrane (1), characterized in that: The inner surface of the first film (1) is fixedly connected to a nitinol mesh (2), the inner surface of the nitinol mesh (2) is fixedly connected to a three - leaf valve (3), the outer surface of the first film (1) is fixedly connected to a ventricular - side positioning member (4), one side surface of the ventricular - side positioning member (4) is fixedly connected to a barb (5), and one end surface of the first film (1) is connected to a left - atrium - side positioning member (6).

2. The heart mitral valve replacement device according to claim 1, characterized in that: The nitinol mesh (2) is integrally formed and is a shape - memory metal that can be compressed and deformed.

3. The heart mitral valve replacement device according to claim 1, wherein: The left - atrium - side positioning member (6) is a shape - memory metal that can be compressed and deformed. When unfolded, the left - atrium - side positioning member (6) is semi - circular. When compressed, it can be retracted into the delivery device. When unfolded, the outer ring of the left - atrium - side positioning member (6) can closely abut against the mitral valve annulus.

4. A heart mitral valve replacement device according to claim 1, characterized in that: The upper surface of the left - atrium - side positioning member (6) is provided with a diamond - shaped mesh structure.

5. The heart mitral valve replacement device according to claim 1, characterized in that: One side surface of the ventricular - side positioning member (4) is provided with multiple groups of barbs (5). The ventricular - side positioning member (4) is provided with multiple groups on the outer surface of the first film (1). The ventricular - side positioning member (4) corresponds to the left - atrium - side positioning member (6).

6. The heart mitral valve replacement device according to claim 1, characterized in that: The nitinol mesh (2), the three - leaf valve (3) and the first film (1) form a valve body.

7. The mitral valve replacement device for the heart according to claim 1, characterized in that: Both the ventricular - side positioning member (4) and the left - atrium - side positioning member (6) are made of materials with shape - memory functions, and the materials are nitinol or cobalt - chromium.

8. The mitral valve replacement device for heart according to claim 1, characterized in that: The three - leaf valve (3) is composed of biological materials, and the valve leaf of the three - leaf valve (3) is semi - lunar.

9. A heart mitral valve replacement device according to claim 1, characterized in that: The ventricular - side positioning member (4) can pass through the chordae tendineae and abut against the lower edge of the mitral valve leaf to form a stable clamping force with the left - atrium - side positioning member (6).

10. A heart mitral valve replacement device according to claim 1, characterized in that: The ventricular - side positioning member (4) has elasticity, and the surfaces of the ventricular - side positioning member (4) and the left - atrium - side positioning member (6) are provided with a second film.

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