Anchoring device for heart valve

By designing a spiral coil-shaped anchoring device without atrial segments, using the spiral coil-shaped structure of elastic material to grab the native petal leaflets or chondromes, the damage and compression problems of the anchoring device to the native tissue in the prior art are solved. Achieve better anchoring effect and simplified implantation process.

CN113303947BActive Publication Date: 2025-01-10SHANGHAI TRULIVE MEDTECH CO LTD +1
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Patent Information

Application Number
CN202110673344.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2021-06-17
Publication Date
2025-01-10
Estimated Expiration
2041-06-17

AI Technical Summary

Technical Problem

The existing heart valve anchoring device is designed to easily cause damage to the native valve leaflets or compress the native valve annulus tissue, affecting the patient's recovery.

Method used

It uses a spiral coil-shaped anchor section made of elastic material, including an anchor section and a grasping section. The anchor section does not include an atrial section. Through the radius of curvature and line spacing of the spiral coil, it can grasp the native petal leaflets or tendon chondria by itself. Reduce the size of the delivery system and simplify the implantation process.

Benefits of technology

It is achieved to reduce compression on native tissue while maintaining the anchoring effect, simplify the delivery device and implantation steps, improve the anchoring effect and adapt to the shape of the valve prosthesis.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to the field of medical devices, and in particular to an anchoring device for a heart valve, the anchoring device comprising a ventricular segment, the ventricular segment comprising an anchoring segment and a grasping segment, the anchoring segment being in the shape of a spiral coil, the radius of curvature of the spiral coil being constant, the spacing between each line of the spiral coil being the same, and the anchoring device not including an atrial segment. The anchoring device is made of an elastic material. The anchoring device of the present invention adopts a design in which the valve and the anchoring device are separated, which can reduce the radial size of the delivery sheath of the delivery system while maintaining the anchoring effect. When the anchoring device is released, the grasping segment can grasp the native leaflet or chordae by itself, which changes the anchoring ring structure in the prior art, does not require a guide wire, and the anchoring segment can surround the native leaflet by itself, thereby simplifying the delivery device and the delivery steps, while having a good anchoring effect and adapting to the shape of the valve prosthesis.
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Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to an anchoring device for a heart valve. Background Art

[0002] The heart contains four chambers, the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). The pumping action of the left and right sides of the heart generally occurs synchronously throughout the cardiac cycle. The valves that separate the atria from the ventricles are called the atrioventricular valves, which act as one-way valves to ensure the normal flow of blood in the heart chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs; blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.

[0003] At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unimpeded flow from the atria into the corresponding ventricles. Shortly after the beginning of ventricular systole (i.e., ventricular emptying), the tricuspid and mitral valves normally close, thereby preventing backflow from the ventricles into the corresponding atria.

[0004] When problems occur with the atrioventricular valves, they are unable to function properly, resulting in improper closure. The atrioventricular valves are complex structures that typically include a valve ring, native leaflets, chordae tendineae, and supporting structures. Each atrium is connected to its valve by the atrial vestibule. The mitral valve has two leaflets, and the attachment or coaptation of the corresponding surfaces of each leaflet to each other helps provide closure or sealing of the valve, thereby preventing blood from flowing in the wrong direction. The failure of the leaflets to seal during ventricular contraction is called malcoaptation, and can allow blood to flow backwards (regurgitation) through the valve. Heart valve regurgitation can have serious consequences for the patient, often leading to heart failure, reduced blood flow, lowered blood pressure, and / or reduced oxygen flow to the body's tissues. Mitral regurgitation can also cause blood from the left atrium to flow back into the pulmonary veins, causing congestion. Severe valvular regurgitation, if not treated, can lead to permanent disability or death.

[0005] Transcatheter mitral valve replacement (TMVR) is a method of catheter intervention, which compresses the artificial valve into the delivery system outside the body, delivers it to the mitral valve ring along the vascular path or through the apex, and releases and fixes the artificial valve at the mitral valve ring to replace the native valve. Compared with surgical operations, TMVR does not require an extracorporeal circulation assist device, is less invasive, and allows patients to recover quickly. The hemodynamic indicators of patients after surgery can be significantly improved. Compared with the apical route, the atrial septal route through the femoral vein is less invasive and has a wider audience.

[0006] Although mitral valve replacement technology has developed rapidly, there are still some recognized difficulties in valve design, such as valve anchoring. Traditional anchoring methods are mainly designed by designing anchor claws to grab the native valve leaflets, or the valve body is oversized (oversize means that the design size of the artificial valve is larger than the size of the native tissue, so that the artificial valve will squeeze the native tissue after release, thereby producing an anchoring effect). However, these two anchoring methods are prone to damage the native valve leaflets or compress the native valve ring tissue, which has an adverse effect on the patient's recovery. Summary of the invention

[0007] In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide an anchoring device for a heart valve to solve the problems in the prior art.

[0008] To achieve the above-mentioned purpose and other related purposes, the present invention provides an anchoring device for a heart valve, wherein the anchoring device includes a ventricular segment, the ventricular segment includes an anchoring segment, the anchoring segment is in the shape of a spiral coil, the curvature radius of the spiral coil is constant, the spacing between each line of the spiral coil is the same, and the anchoring device does not include an atrial segment.

[0009] Preferably, the anchoring device is made of elastic material.

[0010] Preferably, a gripping section is extended from one end of the anchoring section, and the gripping section is in the shape of a spiral coil.

[0011] Preferably, the number of turns of the coil of the grabbing section is 0.5-3 turns.

[0012] Preferably, the radius of curvature of the grasping section is greater than the radius of curvature of the anchoring section.

[0013] The present invention also provides a heart valve replacement device, which includes an anchoring device of the heart valve and a valve prosthesis. The valve prosthesis is configured to be fully or partially placed in an internal space formed by the anchoring device.

[0014] The present invention also provides use of the heart valve anchoring device and / or the heart valve replacement device in preparing a heart valve replacement product.

[0015] The present invention also provides a heart valve replacement system, which includes a heart valve replacement device and a delivery system.

[0016] Preferably, the delivery system comprises a delivery sheath, a delivery catheter and a connector, the delivery catheter is sleeved inside the delivery sheath, and the connector is connected to the delivery catheter.

[0017] Preferably, the connecting piece is a connecting wire or a butt joint.

[0018] As described above, the heart valve anchoring device of the present invention has the following beneficial effects:

[0019] 1. When the anchoring device is released, the native leaflets or chordae can be grasped by the patient.

[0020] 2. The design of separating the valve and the anchoring device can reduce the radial size of the delivery sheath of the delivery system while maintaining the anchoring effect.

[0021] 3. The anchoring ring structure in the prior art has been changed, and no guide wire is required. The valve can surround the native leaflet by itself, which simplifies the delivery device and the delivery steps.

[0022] 4. Good anchoring effect and adaptive valve prosthesis shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 Shown is a schematic diagram of an anchoring device for a heart valve of the present invention.

[0024] Figure 2 Shown is a schematic diagram of the valve prosthesis of the present invention and its implantation process.

[0025] Figure 3 It shows a schematic cross-sectional structure diagram of the heart valve replacement device of the present invention after implantation.

[0026] Figure 4 Shown is a schematic diagram of a connector according to an embodiment of the present invention.

[0027] Figure 5 A schematic diagram of a connector according to another embodiment of the present invention is shown.

[0028] Figure 6 Shown is a schematic diagram of the implantation process of the anchoring device of the heart valve of the present invention.

[0029] Component number description

[0030] 1 Ventricular segment

[0031] 11 Anchoring section

[0032] 111 Free end of anchoring segment

[0033] 111a Through hole

[0034] 12 Crawl segment

[0035] 121 Grab segment free end

[0036] 2 Valve prosthesis

[0037] 21 outflow section

[0038] 22 Valve ring segment

[0039] 23 Inflow section

[0040] 31 Delivery Sheath

[0041] 32 Delivery Catheter

[0042] 33 Connectors

[0043] 331 Threaded end

[0044] 332 Smooth End

[0045] 41 Aorta

[0046] 42 Primary leaflets

[0047] 43 Chordae tendineae

[0048] h Height DETAILED DESCRIPTION

[0049] The following is a description of the implementation of the present invention by means of specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0050] See also Figures 1 to 6 . It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change in the proportional relationship, or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the effects and purposes that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0051] like Figure 1 As shown, the present invention provides an anchoring device for a heart valve, the anchoring device includes a ventricular segment 1, the ventricular segment 1 includes an anchoring segment 11, the anchoring segment 11 is in the shape of a spiral coil, the curvature radius of the spiral coil is constant, the line spacings of the spiral coil are the same, and the anchoring device does not include an atrial segment.

[0052] In the present invention, the anchoring device may also be referred to as an anchoring coil.

[0053] The anchoring device is made of an elastic material. The elastic material is, for example, an elastic wire. In a preferred embodiment, the anchoring device is made of one or more elastic wires. The elastic wire can undergo large elastic deformation in the axial direction, radial direction, and circumferential direction. The anchoring device has elasticity, and its elasticity is determined by the material and shape.

[0054] The material of the elastic wire is selected from metal materials and / or polymer materials. The metal material is selected from one or more of the following: stainless steel, titanium and titanium alloy, nitinol. The polymer material is, for example, nylon. The elastic wire can be made of two or more of the above materials in sections.

[0055] The cross section of the elastic thread is circular or rectangular. The cross section area of ​​the elastic thread can be constant, that is, the thickness of the elastic thread is uniform, and the cross section area can also be variable.

[0056] In one embodiment, a covering layer is provided on the surface of the elastic wire. In one embodiment, the covering layer is a coating or a sleeve. The coating is formed by spraying an organic material, for example. The sleeve is a hollow tube that can be sleeved outside the elastic wire. The hollow tube can be seamlessly extruded or wound and sewn. The covering layer is made of materials such as polyethylene, polytetrafluoroethylene, PET, etc., or a combination thereof.

[0057] The number of turns of the coil of the anchoring section 11 is at least 1. In a preferred embodiment, the number of turns of the coil of the anchoring section 11 is 3.

[0058] The shape of each coil in the helical coil of the anchoring section 11 is selected from arc, circle or ellipse. The curvature radius of each coil of the anchoring section 11 is 5-20 mm.

[0059] The line pitch of the spiral coil is the pitch between adjacent spirals.

[0060] The main function of the anchoring segment 11 is to provide anchoring force for the artificial valve.

[0061] In one embodiment, a covering layer is provided on the surface of the anchoring section 11. The covering layer can further enhance the anchoring effect and increase the high friction coefficient on the surface to improve the anchoring friction force.

[0062] In one embodiment, a gripping section 12 is extended from one end of the anchoring section 11 , and the gripping section 12 is in the shape of a spiral coil.

[0063] The number of turns of the coil of the grabbing section 12 is 0.5-3 turns. The grabbing section 12 can be composed of a single arc or multiple arcs. The radius of curvature of each arc segment of the grabbing section 12 is 5-30 mm.

[0064] The main function of the grasping segment 12 is to grasp native tissues such as native leaflets and chordae tendineae to guide the subsequent anchoring segment 11 to position and play an anchoring role.

[0065] In one embodiment, a covering layer is provided on the surface of the gripping section 12 .

[0066] The covering layer can further increase the gripping effect and reduce the friction coefficient on the surface to reduce the resistance of the gripping section 12 during its travel.

[0067] After the grabbing section 12 is connected to one end of the anchoring section 11 , the grabbing section 12 and the anchoring section 11 each have a free end, namely, a grabbing section free end 121 and an anchoring section free end 111 .

[0068] The free end 111 of the anchoring section is connected to the delivery system. Depending on the delivery system used when the anchoring device is implanted in the body, different components may be provided at the free end 111 of the anchoring section. For example, a thread or a through hole 111a may be provided. The shape of the through hole 111a is not specifically limited, for example, the cross section may be circular, rectangular or waist-shaped. The axis of the through hole 111a may be perpendicular or parallel to the plane of the anchoring device. This arrangement enables the anchoring device to be firmly connected to the delivery system, thereby preventing the anchoring device from slipping during the input process.

[0069] It should be noted that the movement of the native valve will be affected to a certain extent during the release process and after the anchoring device is completely released, but the basic functions of the native valve can still operate normally. Therefore, the heart can maintain normal function during the operation without the need for an external heart-lung machine or heart arrest. This allows physicians to have more time to prepare for the subsequent implantation of the valve prosthesis or perform the operation.

[0070] The line spacing between the grabbing section 12 and the anchoring section 11 is the same as or different from the line spacing in the anchoring section 11, as long as the height h of the anchoring device of the heart valve is appropriate. The height h of the anchoring device of the heart valve is 3 to 20 mm.

[0071] The radius of curvature of the grasping section 12 is greater than that of the anchoring section 11. The larger radius of curvature of the grasping section 12 is more conducive to grasping, thereby grasping the native leaflet or chordae tendineae. The anchoring section 11 has a small radius of curvature to provide the radial force required for anchoring.

[0072] The anchoring device in the prior art contains an atrial segment, which is placed in the atrium after the anchoring device is implanted in the body. The atrial segment will compress the valve ring and easily damage the native valve leaflet, which is not conducive to the patient's recovery. Since the anchoring device of the present application only includes the ventricular segment and does not include the atrial segment, it will not compress the valve ring and can also prevent the anchoring device from falling off.

[0073] The present invention further provides a heart valve replacement device, which comprises an anchoring device of the heart valve and a valve prosthesis 2. The valve prosthesis 2 is configured to be fully or partially placed in an internal space formed by the anchoring device.

[0074] like Figure 2 As shown, the valve prosthesis 2 is a cylindrical shape with two ends opened, and includes an outflow section 21 and a valve ring section 22 connected to each other. The outflow section 21 is configured to be fully or partially placed in the internal space formed by the anchoring device, and / or the valve ring section 22 is configured to be fully or partially placed in the internal space formed by the anchoring device.

[0075] In a preferred embodiment, the valve prosthesis 2 further comprises an inflow section 23 connected to the valve ring section 22. The inflow section 23 is configured as a flange structure, which can make the valve prosthesis 2 more stable and prevent paravalvular leakage.

[0076] The cylindrical shape is a hollow shape, for example, it can be a cylindrical shape, a conical shape, a waist-shaped shape or other cylindrical shapes.

[0077] The valve prosthesis 2 can replace the natural mitral valve or tricuspid valve. The valve prosthesis 2 enters the atrium via the inferior vena cava or other pathways, passes through the atrial septum and enters the internal space formed by the anchoring device, and can then be released in the anchoring device by means of one-time balloon expansion or self-expansion segmented sheath withdrawal.

[0078] The cross-sectional structure of a heart valve replacement device after implantation in the body Figure 3 As shown in the figure, the valve prosthesis 2 is provided with an inflow section 23, and the outflow section 21 is approximately cylindrical, and the implantation site is the mitral valve. The valve ring section 22 is located at the native valve ring, and the native tissue (native valve leaflets or tendons) is affected by the anchoring device and the valve prosthesis 2, and fits the outer contour surface of the valve prosthesis 2. The anchoring device is evenly wrapped around the native valve leaflets or tendons, thereby providing anchoring force. The free end 121 of the grasping section and the free end 111 of the anchoring section fit the native valve leaflets or valve to reduce the impact on the blood flow of the heart.

[0079] The present invention also provides use of the heart valve anchoring device and / or the heart valve replacement device in preparing a heart valve replacement product.

[0080] The anchoring device and the valve prosthesis 2 in the heart valve replacement product are introduced through different routes.

[0081] The present invention also provides a heart valve replacement system, which includes a heart valve replacement device and a delivery system.

[0082] The delivery system is a device for implanting a heart valve replacement device into a human body.

[0083] like Figure 2 and 6As shown, the delivery system includes a delivery sheath 31, a delivery catheter 32 and a connector 33. The delivery catheter 32 is sleeved in the delivery sheath 31, and the connector 33 is connected to the delivery catheter 32. The delivery system may also include other components, such as a handle.

[0084] In such Figure 4 In the embodiment shown, the connector 33 is a connecting thread. The connecting thread is selected from metal elastic wire, surgical suture, tether or strip, etc. The connecting thread can be made of one or more materials. The material of the connecting thread is, for example, one or more of nickel titanium, stainless steel, nylon, and other biocompatible materials. The number of connecting threads can be one or more. In this embodiment, the free end 111 of the anchoring segment is provided with a through hole 111a. The connecting thread can pass through the through hole 111a and enter the delivery catheter 32 and then be connected to the handle or other components of the delivery system, or it can be fixed to the through hole 111a in other ways. Preferably, the connecting thread can leave a little margin inside or outside the delivery catheter 32 so as not to hinder the free end 111 of the anchoring segment from retreating and fitting to the outer contour of the valve when the anchoring device is unwound. After the implantation of the valve prosthesis 2 is completed, the connecting thread is cut and pulled out of the delivery system.

[0085] In such Figure 5 In the embodiment shown, the connector 33 is a butt joint, one end of which is a threaded end 331 and the other end is a smooth end 332. In this embodiment, one end of the delivery catheter 32 is provided with a thread matching the threaded end 331. When implanted, the smooth end 332 of the butt joint is fixedly connected to the free end 111 of the anchoring segment. The fixed connection is selected from welding or clamping connection.

[0086] The heart valve of the present invention is selected from the mitral valve or the tricuspid valve.

[0087] The implantation process of the heart valve replacement system of the present invention is as follows:

[0088] The anchor release process is as follows Figure 2, the delivery sheath 31 can enter the left ventricle via the aorta 41 or other paths, and then the delivery catheter 32 is released from the delivery sheath 31, and the delivery catheter 32 forms a semicircular or other arc-shaped trajectory along the ventricular wall, and the trajectory surrounds part of the native tissue (native leaflets and / or chordae tendineae), thereby forming a release path for the anchoring device. After the trajectory release is completed, the anchoring device can be pushed into the left ventricle through the delivery catheter 32. The free end 121 of the grasping segment is released first. Because of its large radius of curvature, it can also travel along the ventricular wall to grasp the native leaflets 42 and / or chordae tendineae 43, forming a circular arc coil that is approximately parallel to the valve ring. The remaining part of the anchoring device will continue to be released along the grasping segment trajectory. As the anchoring device is advanced, the smaller diameter anchoring segment 11 begins to enter the ventricle, and the anchoring segment 11 can further wrap the native leaflets 42 and / or chordae tendineae 43 into the anchoring device. Continue to advance the anchoring device until the free end 111 of the anchoring segment is out of the delivery catheter 32, and the release of the anchoring device is completed.

[0089] The process of implanting a valve prosthesis Figure 3 After the anchoring device is released, the valve prosthesis 2 begins to be implanted. The valve prosthesis 2 enters the atrium via the inferior vena cava or other paths, passes through the atrial septum and enters the anchoring device, and is then released in the anchoring device by means of a one-time balloon expansion or a self-expanding segmented sheath withdrawal. The anchoring segment 11 will expand in diameter after being subjected to force, and the anchoring device will produce elastic and / or plastic deformation. When the anchoring segment 11 is deformed, it will adaptively adapt to the outer contour of the implanted valve prosthesis 2 and produce an anchoring force on the valve prosthesis 2. When the anchoring segment 11 is deformed by expansion, the coil of the grasping segment 12 will unwind, that is, the free end 121 of the grasping segment will retreat along the coil. Preferably, after the grasping segment 12 is unwound, it will also be close to the outer contour of the valve prosthesis 2 to provide an anchoring effect. When the anchoring segment 11 is deformed by expansion, the free end 111 of the anchoring segment also has a tendency to unwind. At this time, the degree of unwinding can be controlled by the connector 33, and the free end 111 of the anchoring segment can also be unwound to avoid affecting the outflow of ventricular blood. After the free end 111 of the anchoring section is unwound, it is closely attached to the outer contour of the valve prosthesis 2 to provide an anchoring effect. After the valve prosthesis 2 is completely released and it is confirmed that the valve prosthesis 2 and the anchoring device have been firmly implanted in the set position, the delivery system is withdrawn, and the connection between the connector 33 and the free end 111 of the anchoring section of the anchoring device is released, thereby withdrawing the delivery system, completing the implantation of the entire valve prosthesis 2 and the anchoring device. The cross-sectional structure of the heart valve replacement device after implantation in the body is as follows: Figure 3 shown.

[0090] The anchoring device of the present invention is implanted through the aortic route, and the valve prosthesis is implanted from another route. The implantation method of the present invention can achieve that the delivery system of the anchoring device is not withdrawn when the valve prosthesis is implanted, and the anchoring device is always fixed through the delivery system until the valve prosthesis is in place. This implantation method provides a basis for the anchoring device of the present invention not including the atrial segment. The anchoring device without the atrial segment reduces the compression and blockage of the heart tissue, and the anchoring device can be initially released in the ventricle by entering from the aorta instead of from the atrial septum route, and the force changes after the valve prosthesis is released, thereby providing anchoring force. In the prior art, the anchoring device and the valve prosthesis are implanted through the same route of the apex or the atrial septum, so when the valve prosthesis is implanted, the delivery system must be withdrawn. At this time, after the delivery system is withdrawn, if the anchoring device does not contain the atrial segment to fix it, then the anchoring device is easy to slip off, so that the anchoring device must include the atrial segment. Therefore, the atrial segment of the anchoring device in the prior art can fix the anchoring device during the period when the delivery system is withdrawn when the valve prosthesis is implanted, ensuring that the anchoring device does not slip off.

[0091] In summary, the present invention effectively overcomes various shortcomings of the prior art and has high industrial utilization value.

[0092] The above embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Anyone familiar with the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by a person of ordinary skill in the art without departing from the spirit and technical concept disclosed by the present invention shall still be covered by the claims of the present invention.

Claims

1. A heart valve replacement device, characterized in that: The heart valve replacement device comprises a heart valve anchoring device and a valve prosthesis (2), wherein the anchoring device comprises a ventricular segment (1), wherein the ventricular segment (1) comprises an anchoring segment (11), wherein the anchoring segment (11) is in the shape of a spiral coil, wherein the radius of curvature of the spiral coil is constant, and the spacing between the lines of the spiral coil is the same; the anchoring device does not comprise an atrial segment, wherein one end of the anchoring segment (11) is provided with a gripping segment (12), wherein the gripping segment (12) is in the shape of a spiral coil, wherein the radius of curvature of the gripping segment (12) is greater than the radius of curvature of the anchoring segment (11), and wherein the gripping segment (12) comprises a gripping segment free end (121); the valve prosthesis (2) is configured to be fully or partially placed in the internal space formed by the anchoring device, wherein the gripping segment (12) is in the shape of a spiral coil, wherein the radius of curvature of the gripping segment (12) is greater than the radius of curvature of the anchoring segment (11), and wherein the gripping segment (12) comprises a gripping segment free end (121); The valve prosthesis (2) is cylindrical with two ends open, and comprises an outflow section (21), a valve ring section (22) and an inflow section (23) connected in sequence; the outflow section (21) is configured to be suitable for being placed in whole or in part in the internal space formed by the anchoring device, the valve ring section (22) is configured to be suitable for being placed in whole or in part in the internal space formed by the anchoring device, and the inflow section (23) is configured to be a flange structure. The anchoring device and the valve prosthesis (2) are separate, and the anchoring device is made of elastic material. The shape of the anchoring device matches the shape of the delivery sheath in the delivery system. During delivery, the free end (121) of the grasping section is first released to form a circular arc coil approximately parallel to the valve ring, and the remaining part of the anchoring device is then released.

2. The heart valve replacement device according to claim 1, characterized in that: A covering layer is provided on the surface of the elastic material.

3. The heart valve replacement device according to claim 1, characterized in that: The number of turns of the coil of the grabbing section (12) is 0.5-3 turns.

4. The heart valve replacement device according to claim 1, characterized in that: The height h of the anchoring device is 3 to 20 mm.

5. Use of the heart valve replacement device according to any one of claims 1 to 4 in the preparation of heart valve replacement products.

6. The use according to claim 5, characterized in that The anchoring device and the valve prosthesis (2) in the heart valve replacement product are introduced through different routes.

7. A heart valve replacement system, characterized in that: The heart valve replacement system comprises the heart valve replacement device and delivery system described in any one of claims 1-4.

8. The heart valve replacement system according to claim 7, characterized in that: The delivery system comprises a delivery sheath (31), a delivery catheter (32) and a connector (33); the delivery catheter (32) is sleeved inside the delivery sheath (31), and the connector (33) is connected to the delivery catheter (32).

9. The heart valve replacement system according to claim 8, characterized in that: The connecting piece (33) is a connecting thread, and the free end (111) of the anchoring section is correspondingly provided with a through hole (111a).

10. The heart valve replacement system according to claim 8, characterized in that: The connecting piece (33) is a docking joint, one end of which is a threaded end (331) and the other end is a smooth end (332). Accordingly, one end of the delivery catheter (32) is provided with a thread matching the threaded end (331), and the smooth end (332) is configured to be suitable for connection with the free end (111) of the anchoring section.

Citation Information

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