Anchoring device for a prosthetic heart valve and prosthetic heart valve system

Abstract

The application provides an anchoring device of an artificial heart valve and an artificial heart valve system, the artificial heart valve system comprising an anchoring device and an artificial heart valve, the anchoring device comprising an anchoring section and a supporting section which are connected to each other in an axial direction, the anchoring section having a first cavity in the shape of a ring capable of accommodating the artificial heart valve; the supporting section is arranged on one side of the anchoring section in the axial direction, the supporting section comprising at least two elastic wires arranged in sequence along the circumference of the anchoring section, one end of each of the elastic wires being connected to the anchoring section, and the other end of each of the elastic wires extending away from the anchoring section. The anchoring device can realize the anchoring of the artificial heart valve by using the structure of a predetermined cavity, and is not required to cross the native valve annulus when implanted, thereby effectively preventing the generation of paravalvular leakage after the implantation of the artificial heart valve.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an anchoring device for an artificial heart valve and an artificial heart valve system. Background Technology

[0002] Transcatheter mitral valve replacement (TMVR) is a procedure that uses a catheter to deliver an artificial heart valve via a delivery system, compressing it outside the body. The valve is then transported along a vascular pathway or through the apex of the heart to the mitral valve annulus, where it is released and fixed to replace the native valve. Compared to traditional surgical procedures, mitral valve replacement does not require cardiopulmonary bypass, is less invasive, allows for faster patient recovery, and significantly improves postoperative hemodynamic parameters. Furthermore, the transatrial septal approach via the femoral vein is less invasive and has a wider range of recipients compared to the apical approach.

[0003] Although mitral valve replacement technology has advanced rapidly, the anchoring methods for artificial heart valves still have certain limitations. Traditional anchoring methods mainly involve designing anchoring spikes to grasp the leaflets to fix the artificial heart valve, or by over-sizing the artificial heart valve body. However, both of these anchoring methods can easily cause damage to the original leaflets or compression of the original valve annulus tissue, thus adversely affecting the patient's recovery.

[0004] Existing artificial heart valve technologies employ a design where the anchoring device is separate from the artificial heart valve itself. For example, an artificial heart valve may consist of a multi-turn docking coil and a cylindrical valve body. This separation of the anchoring device and valve body effectively avoids compression of the native valve annulus and minimizes damage to the valve leaflets. It also reduces the size of the delivery system components, facilitating its movement within the body. However, this docking coil includes both atrial and ventricular segments. The connection between these segments passes through the native valve annulus, posing a risk of paravalvular leakage at the annulus. Furthermore, the complex release process and precise positioning of the docking coil increase the difficulty of the artificial heart valve implantation surgery, demanding a high level of operator skill. The prolonged surgical time also negatively impacts the patient's health. Summary of the Invention

[0005] To address the technical problems existing in the prior art, the present invention aims to provide an anchoring device and an artificial heart valve system. The anchoring device can anchor the artificial heart valve using the structure of a predetermined chamber, and does not need to cross the original valve annulus during implantation, thereby effectively preventing paravalvular leakage after the artificial heart valve is implanted.

[0006] To achieve at least one of the above objectives, the present invention provides an anchoring device for an artificial heart valve, comprising an anchoring section and a support section axially connected to each other; the anchoring section has an annular first cavity capable of accommodating the artificial heart valve, and when the anchoring section is deformed under force, it is adapted to the external contour of the artificial heart valve to apply an anchoring force to the artificial heart valve.

[0007] The support section is disposed on one side of the anchoring section along the axial direction. The support section includes at least two elastic wires arranged sequentially along the circumference of the anchoring section. One end of each elastic wire is connected to the anchoring section, and the other end extends away from the anchoring section.

[0008] The anchoring device is configured such that the anchoring section is disposed at the petal ring of the predetermined object, and the support section is disposed in the predetermined cavity of the predetermined object and can be fixed in the predetermined cavity by elastic force.

[0009] Optionally, in the radial direction of the anchoring device, the maximum outer diameter of the expanded support section is greater than the inner diameter of the part where the predetermined chamber contacts the support section, and / or, in the axial direction of the anchoring device, the axial height of the expanded support section is greater than the axial height of the predetermined chamber.

[0010] Optionally, at least a portion of the contour of the elastic filament along its extension direction is curved.

[0011] Optionally, at least a portion of the contour of the elastic filament along its extension direction is arc-shaped or wavy.

[0012] Optionally, the elastic wire includes clearance sections, all of which together define a second cavity for accommodating at least a portion of the artificial heart valve, and the inner diameter of the second cavity is larger than the inner diameter of the first cavity after the anchoring device expands.

[0013] Optionally, the anchoring device for the artificial heart valve further includes a fixing portion connected to at least a portion of the other end of the elastic wire, the fixing portion being disposed in the predetermined chamber.

[0014] Optionally, the fixing part is a fixing ring, and after the anchoring device expands, the inner diameter of the fixing ring is smaller than the inner diameter of the first cavity.

[0015] Optionally, all the elastic wires are evenly distributed circumferentially along the anchoring section.

[0016] Optionally, the anchoring section is a coil structure made of wire, and the coil structure has at least one coil turn.

[0017] To achieve the above objectives, the present invention also provides an artificial heart valve system, comprising an artificial heart valve and an anchoring device for the artificial heart valve as described in any one of the present inventions, wherein the artificial heart valve is accommodated in the anchoring device and fixed in a predetermined object by the anchoring device.

[0018] The artificial heart valve anchoring device and artificial heart valve system provided by this invention can fix the artificial heart valve to the heart valve annulus through the anchoring device. In specific implementation, the anchoring section of the anchoring device is set at the position of the original valve annulus, and the anchoring section is fixed by means of the anchoring of the support section in the atrium or ventricle. In this method, since the anchoring device only sets the support section on one side of the axial direction of the anchoring section, the support section does not need to cross the original valve annulus, thereby effectively preventing paravalvular leakage. At the same time, this anchoring method also avoids damage to the original valve leaflet or compression of the original valve annulus tissue. The surgery has good safety and reliability and is beneficial to the patient's postoperative recovery.

[0019] The artificial heart valve anchoring device provided by this invention achieves anchoring solely through the elasticity of the support segment and the interference fit between it and the atrium or ventricle, and through the interference fit between the first cavity of the anchoring segment and the artificial heart valve. This method results in a simple structure, and the anchoring segment can be automatically moved to the desired implantation position by releasing it from any position in the atrium or ventricle during implantation. This simplifies the implantation process of the anchoring device, reduces the difficulty of implantation, and improves the reliability and convenience of artificial heart valve surgery. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the anchoring device in Embodiment 1 of the present invention;

[0021] Figure 2 This is a schematic diagram of the anchoring device in a preferred embodiment of Embodiment 2 of the present invention;

[0022] Figure 3 This is a schematic diagram of the anchoring device in another preferred embodiment of the present invention;

[0023] Figure 4 This is a schematic diagram of the anchoring device in Embodiment 3 of the present invention;

[0024] Figure 5 This is a schematic diagram of the application scenario of the anchoring device in Embodiment 3 of the present invention.

[0025] In the figure: Anchoring devices 100, 200, 300; Anchoring sections 110, 210, 310; First cavities 111, 211, 311; Support sections 120, 220, 320; Elastic wires 121, 221, 321; Avoidance sections 222, 322; Fixing parts 130, 230; Artificial heart valve 400; Outflow section 410; Valve annulus section 420; Flange section 430. Detailed Implementation

[0026] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present invention.

[0027] The terms “center,” “longitudinal,” “lateral,” “length,” “width,” “thickness,” “upper,” “lower,” “front,” “rear,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” “outer,” “clockwise,” “counterclockwise,” “axial,” “radial,” and “circumferential” indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0028] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "fixation," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between them; they can refer to a direct connection or a connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances. In this document, the term "radial" refers to the direction parallel to the native valve annulus after the anchoring device is implanted in the heart, i.e., the radial direction of the native valve annulus; the term "axial" refers to the direction perpendicular to the native valve annulus after the anchoring device is implanted in the heart, i.e., the axial direction of the native valve annulus.

[0029] The core idea of ​​this invention is to provide an anchoring device and system for an artificial heart valve. This device securely anchors the artificial heart valve to the native valve annulus in the heart, such as the aortic, tricuspid, or mitral valve, thereby replacing the original heart valve (aortic, tricuspid, or mitral valve). It should be understood that the heart contains four chambers: the left atrium (LA), right ventricle (RV), right atrium (RA), and left ventricle (LV). During the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs synchronously. The thin membrane separating the atria and ventricles is called the atrioventricular valve. Each atrium is connected to its corresponding atrial valve via the atrial vestibule. The atrioventricular valves act as one-way valves, ensuring normal blood flow within the heart chambers. The atrioventricular valve between the left atrium and left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery, allowing blood to flow to the lungs; then, blood flows through the pulmonary veins to the left atrium. The aortic valve guides blood flow through the aorta to the rest of the body.

[0030] During ventricular filling (diastole), the aortic and pulmonary valves close to prevent blood from flowing back into the ventricles; simultaneously, the mitral and tricuspid valves open to allow blood to flow from the atria into the corresponding ventricles. During ventricular systole (emptying), the mitral and tricuspid valves close to prevent blood from flowing from the atria into the corresponding ventricles; simultaneously, the aortic and pulmonary valves open to allow blood to be pumped out of the ventricles and through the aorta and pulmonary artery to reach the whole body and lungs; then the left and right atria relax to allow peripheral blood to flow back into the left and right atria.

[0031] When the atrioventricular valves malfunction, they often fail to close properly. The atrioventricular valves typically consist of an annulus, leaflets, chordae tendineae, and supporting structures. The mitral valve has two leaflets, and the tricuspid valve has three. The contact between these leaflets closes or seals the mitral or tricuspid valve, preventing blood flow between the ventricles and atria during ventricular systole. Incomplete sealing between the leaflets of the mitral and tricuspid valves is called valvular regurgitation or malcontinence. In this case, during ventricular systole, blood in the ventricles can flow back into the corresponding atria through the gap between the mitral or tricuspid valves. This often leads to heart failure, reduced blood flow, decreased blood pressure, and reduced oxygen levels reaching the body's tissues. Furthermore, atrioventricular regurgitation can cause blood to flow from the left atrium back into the pulmonary veins, causing pulmonary congestion. Severe atrioventricular regurgitation, if left untreated, can lead to permanent disability or death.

[0032] As mentioned in the background section, traditional artificial heart valves can cause damage to the native leaflet or compression of the native valve annulus tissue during anchoring, as well as the risk of paravalvular leakage at the native valve annulus, and also have problems such as complex surgical procedures.

[0033] To address at least one technical problem in the prior art, the present invention improves the anchoring device for an artificial heart valve. Specifically, the anchoring device includes an anchoring section and a support section axially connected to each other. The anchoring section has an annular first cavity capable of accommodating the artificial heart valve and, when the anchoring section is deformed under force, adapts to the external contour of the artificial heart valve to apply an anchoring force to the artificial heart valve. The support section is disposed on one side of the anchoring section along the axial direction and includes at least two elastic wires arranged sequentially along the circumference of the anchoring section. One end of each elastic wire is connected to the anchoring section, and the other end extends away from the anchoring section. The anchoring device is configured such that the anchoring section is used to be disposed at the valve annulus of a predetermined object, and the support section is used to be disposed in a predetermined chamber of the predetermined object and can be fixed in the predetermined chamber by elastic force. This configuration allows the anchoring device to anchor the artificial heart valve using a predetermined chamber such as the atrium or ventricle. This anchoring method not only avoids damage to the native valve leaflet or compression of the native valve annulus tissue, but also ensures that the support segment does not need to cross the native valve annulus during implantation, effectively preventing paravalvular leakage. It also simplifies the surgical procedure and reduces its difficulty. It should be understood that the predetermined object refers to the main body on which the artificial heart valve will be implanted, generally referring to the human heart. The predetermined chamber refers to a chamber within the heart capable of accommodating and fixing the support segment; the predetermined chamber can be an atrium or ventricle, preferably an atrium.

[0034] The present invention will now be described in detail with reference to the accompanying drawings and preferred embodiments. Unless otherwise specified, the following embodiments and features can complement or combine with each other.

[0035] <Example 1>

[0036] like Figure 1 As shown, a preferred embodiment of the present invention provides an anchoring device 100 for an artificial heart valve. The anchoring device 100 includes an anchoring section 110 and a support section 120 axially connected to each other. The support section 120 defines the position of the anchoring section 110. Specifically, the support section 120 primarily supports the anchoring section 110 using native myocardial tissue such as the atrial or ventricular wall to prevent displacement of the anchoring section 110 during the cardiac cycle. The support section 120 is only located on one side of the anchoring section 110 along its axial direction to avoid crossing the native valve annulus. The support section 120 includes at least two elastic wires 121 arranged sequentially along the circumference of the anchoring section 110. One end of each elastic wire 121 is connected to the anchoring section 110, and the other end extends away from the anchoring section 110. Specifically, the extending direction of the elastic wire 121 is parallel to the axial direction of the anchoring section 110, or forms an angle of less than or equal to 90° with the axial direction of the anchoring section 110. The axial direction of the anchoring section 110 here refers to the direction from the anchoring section 110 to the support section 120.

[0037] The anchoring segment 110 has an annular first cavity 111 capable of accommodating the artificial heart valve. When the anchoring segment 110 is deformed under force, it adapts to the external contour of the artificial heart valve to apply an anchoring force to the artificial heart valve. After the anchoring force is applied, the artificial heart valve and the anchoring segment 110 are fixed to each other. Specifically, when the artificial heart valve is released within the anchoring device 100, the anchoring segment 110 expands under the force of the artificial heart valve release, causing elastic and / or plastic deformation. When the anchoring segment 110 deforms, it adapts to the external contour of the artificial heart valve, thereby generating an anchoring force to the artificial heart valve, so that the anchoring segment 110 and the artificial heart valve are sealed and fixedly connected.

[0038] A preferred embodiment of the present invention also provides an artificial heart valve system, including an artificial heart valve and an anchoring device 100. The artificial heart valve is housed in the anchoring device 100, thereby providing an anchoring force to the artificial heart valve within the heart. The anchoring device 100 provided by the present invention can be implanted and fixed before the artificial heart valve, thus providing the anchoring force required for anchoring the artificial heart valve in advance.

[0039] More specifically, after the anchoring device 100 is implanted into the human heart and released, the anchoring segment 110 is located at the original valve annulus, and the support segment 120 is released into the atrium or ventricle. The support segment 120 is anchored in the atrium or ventricle by the elastic force exerted on its inner wall by the wall, thus also anchoring the anchoring segment 110 at the original valve annulus. This arrangement, on the one hand, places the support segment 120 only on one side of the anchoring segment 110, eliminating the need for the support segment 120 to cross the original valve annulus, thereby effectively preventing paravalvular leakage. On the other hand, this anchoring method avoids damage to the original valve leaflet or compression of the original valve annulus tissue, while also simplifying the surgical procedure and reducing its difficulty.

[0040] It should also be understood that the anchoring device 100 provided by this invention has virtually no impact on the movement of the native leaflet during release. That is, the implantation process of the anchoring device 100 does not hinder the basic function of the native leaflet. This ensures that the heart can continue its normal cyclical movement throughout the implantation process without the need for an external pulmonary machine or cardiac arrest, thereby reducing the difficulty of the surgery and providing the operator with more time to adjust the implantation position of the anchoring device 100 and to better prepare for the implantation of the artificial heart valve. This significantly reduces patient discomfort and increases the success rate of the surgery. Furthermore, the anchoring device 100 of this invention does not require an anchoring spur or oversized artificial heart valves for fixation, thus avoiding damage to the native leaflet or compression of the native valve annulus tissue. This results in minimal surgical trauma and is more conducive to postoperative recovery for the patient.

[0041] It should be understood that the elastic wire 121 is made of elastic material, which allows the support segment 120 to elastically deform in the radial and / or axial directions of the anchoring device 100. When the support segment 120 is released in the atrium or ventricle, the elastic deformation of the support segment 120 allows it to apply an elastic force to the inner wall of the atrium or ventricle, so that the support segment 120 can use the elastic force to achieve a firm connection with the atrium or ventricle, thereby ensuring that the anchoring segment 110 remains in the implantation position throughout the cardiac cycle.

[0042] Preferably, the anchoring device 100 is fixed in the atrium, such as the right or left atrium. In a specific embodiment, the anchoring device 100 can enter the atrium through the interatrial septum or the apex of the heart, and release the anchoring segment 110 and the support segment 120 in the atrium. After release, the anchoring segment 110 can naturally shift to the position of the original valve annulus under the action of the expansion force of the support segment 120, while the support segment 120 can apply an elastic force to the inner wall of the atrium after release, so that the anchoring segment 110 is anchored at the position of the original valve annulus.

[0043] This application does not limit the elastic material used to prepare the support segment 120, as long as it is a metallic or polymeric material capable of elastic deformation. For example, the material of the support segment 120 can be one or more combinations of stainless steel, titanium alloy, and nickel-titanium alloy. The material of the support segment 120 can also be a polymeric material, such as nylon. The support segment 120 can be a one-piece molded structure, such as by cutting to form multiple elastic wires 121. The support segment 120 can also be a modular molded structure, where the elastic wires 121 are individually manufactured and then connected to the anchoring segment 110. The materials of the multiple elastic wires 121 can be the same or different, and each elastic wire 121 can be prepared from one or more materials, for example, segments of different types of materials can be connected to form the elastic wire 121. The elastic wire 121 can be a solid or hollow structure, as long as it can provide sufficiently strong support. The cross-sectional shape of the elastic wire 121 is not limited; it can be circular, annular, or rectangular, or it can be a variable diameter or variable cross-section design, meaning that the cross-sectional dimensions or shapes of the same elastic wire 121 differ at different locations to meet the design requirements of the anchoring device 100. To increase the frictional force of the elastic wire 121 during anchoring, i.e., to further enhance the anchoring effect of the support section 120 within the core, a high-friction coefficient coating can be applied to the surface of the elastic wire 121. The high-friction coefficient coating can be one or more of polyethylene, polytetrafluoroethylene, and PET materials, or a combination thereof.

[0044] This application does not limit the number of elastic wires 121. Preferably, all elastic wires 121 are evenly distributed circumferentially along the anchoring segment 110. Even distribution here can be understood as the elastic wires 121 having the same spacing. This simplifies the structure and size of the anchoring device 100, improves the anchoring effect, and allows the anchoring segment 110 to move automatically to the desired implantation location even when released from any position in the atrium or ventricle during implantation. This simplifies the implantation process and reduces the difficulty of implantation, thereby improving the reliability and convenience of artificial heart valve surgery.

[0045] Continue to refer to Figure 1 As shown, in this embodiment, the support section 120 includes four elastic wires 121, which are evenly distributed along the circumference of the anchoring section 110. Of course, in other embodiments, the number of elastic wires 121 in the support section 120 can also be set to 2, 3, 5, 6 or more.

[0046] Preferably, the anchoring segment 110 is a coil structure made of wire, wherein the coil structure is at least a partial loop. In one embodiment, the anchoring segment 110 may be made of wire of one material. In another embodiment, the anchoring segment 110 may also be formed by connecting segments of wire of two or more materials, for example, wires of different kinds may be connected to each other to form an anchoring ring. In a specific embodiment, such as Figure 1 As shown, the anchoring segment 110 is a single annular structure forming an anchoring ring, which facilitates the implantation of the anchoring segment 110 at the location of the original valve annulus and also facilitates the distribution of the elastic wire 121 circumferentially within the anchoring segment 110. Besides the single annular structure shown, the anchoring segment 110 can also be composed of multiple coaxial annular structures, which are fixedly connected. Specifically, the anchoring segment 110 may include multiple parallel anchoring rings distributed axially, which are sequentially connected. The diameters of the multiple anchoring rings can be the same or different, preferably different, to better fit the contour of the implanted heart valve. In another specific embodiment, the anchoring segment 110 is a helical coil. Typically, the number of turns in the helical structure is 1-5 turns, which refers to the number of turns of the helical coil. Preferably, it is 1-2 turns, allowing the anchoring segment 110 to easily undergo elastic deformation during implantation and expansion of the artificial heart valve.

[0047] This application does not limit the material used to prepare the anchoring segment 110. Preferably, the anchoring segment 110 is made of an elastic material. The anchoring segment 110 is at least capable of elastic deformation in the radial direction of the anchoring device 100, so that the anchoring segment 110 can be better fixed and sealed with the artificial heart valve, thereby effectively preventing paravalvular leakage. This application does not limit the elastic material used to prepare the anchoring segment 110; any metal or polymer material capable of elastic deformation is acceptable. In the embodiments of this invention, the material of the anchoring segment 110 can be one or more combinations of stainless steel, titanium alloy, and nickel-titanium alloy. The material of the anchoring segment 110 can also be a polymer material, such as nylon, polyethylene, polyurethane, silicone, etc.

[0048] This application does not limit the cross-sectional shape of the wire used to prepare the anchoring section 110. The cross-sectional shape of the wire can be circular, annular, or rectangular, or it can be a design with varying diameter or cross-section, that is, the cross-sectional dimensions or shapes of the same wire are different at different locations to meet the design requirements of the anchoring device 100. To increase the frictional force during anchoring of the anchoring section 110, that is, to further increase the anchoring effect of the anchoring section 110 in the heart, a high-friction coefficient coating layer can be coated on the surface of the wire used to prepare the anchoring section 110. Here, the high-friction coefficient coating layer can be one or more of polyethylene, polytetrafluoroethylene, and PET materials.

[0049] In one example, the anchoring section 110 and the support section 120 can be made from different wires, and then connected to form the anchoring device 100. That is, the anchoring section 110 and the support section 120 are made separately and then connected to each other. In other examples, the same wire can be wound sequentially to form the anchoring section 110 and the support section 120 to form an integrated anchoring device 100.

[0050] Reference Figure 1 As shown, in the radial direction of the anchoring device 100, the maximum outer diameter D1 of the expanded support section 120 is greater than the inner diameter of the part of the atrium or ventricle that contacts the support section 120. This arrangement allows the support section 120 to be anchored in the radial direction with an interference fit with the atrium or ventricle, thereby enabling a more secure connection between the support section 120 and the atrium or ventricle.

[0051] This application does not limit the cross-sectional shape of the expanded support segment 120, as long as at least a portion of the outer diameter of the expanded cross-section can form an interference fit with the atrium or ventricle. Preferably, the shape of a portion of the outer contour of the expanded support segment 120 matches the shape of the contact area to increase the contact area and enhance the anchoring force. For example, the shape of the outer contour of the expanded support segment 120 can be spherical or near-spherical, resulting in better anchoring. Furthermore, the outer contour of the expanded support segment 120 can also be other shapes, such as elliptical or cylindrical.

[0052] It should also be understood that in existing anchoring devices, the docking coil must be released from the junctional leaflet to release the atrial or ventricular segment coil. During release, the coil plane must be parallel to the original valve annulus, and the released atrial or ventricular segment coil must encircle the entire original valve leaflet. This process is time-consuming and requires a high level of operator skill, which not only prolongs the patient's surgical time and causes significant pain, but also greatly increases the risk of subsequent surgical failure due to inaccurate placement of the docking coil. In contrast, this application distributes the elastic wire 121 of the support segment 120 evenly along the circumference of the anchoring segment 110, allowing the anchoring device 100 to be released at any position within the predetermined chamber without needing to find a specific angle and orientation to release the support segment 120. The anchoring device 100 can then move automatically to the desired implantation location. Specifically, after the anchoring segment 110 is released, it can automatically move to the original valve annulus position. After the elastic wires 121 on the support segment 120 are fully released and expanded, the symmetrically arranged elastic wires 121 can automatically adjust the implantation position until each elastic wire 121 can provide the same amount of elastic force to the predetermined cavity. Therefore, after the anchoring device 100 is released in the predetermined cavity, both the anchoring segment 110 and the support segment 120 in the anchoring device 100 can automatically move to the required implantation position. This simplifies the implantation difficulty of the anchoring device 10, greatly improves the efficiency and success rate of the operation, and reduces the patient's pain.

[0053] To ensure that the anchoring segment 110 is accurately positioned at the location of the original valve annulus, the inner diameter of the first cavity 111 typically corresponds to the size of the original valve annulus. In this embodiment, for example, the inner diameter of the first cavity 111 is 35mm to 55mm. This allows the outer diameter of the anchoring segment 110 to be greater than or equal to the inner diameter of the original valve annulus, enabling the anchoring segment 110 to be better anchored and sealed at the location of the original valve annulus. This application does not limit the shape of the anchoring segment 110. Preferably, the shape of the expanded outer contour of the anchoring segment 110 corresponds to the inner contour of the original valve annulus for better anchoring. For example, the expanded shape of the anchoring segment 110 can be circular or elliptical.

[0054] This application does not impose any particular limitation on the outline shape of the elastic filament 121 along the extension direction. At least a portion of the outline of the elastic filament 121 along the extension direction may be curved, that is, the outline shape of the elastic filament 121 along the extension direction may be curved, or formed by connecting curves and straight lines. Preferably, at least a portion of the outline of the elastic filament 121 along the extension direction may be arc-shaped or wavy. (Continuing to refer to...) Figure 1 As shown, in this embodiment, the elastic wire 121 in the support segment 120 is arc-shaped, which allows the elastic wire 121 to better fit the predetermined cavity, thereby increasing the anchoring force and preventing damage to the myocardial tissue. Of course, in other embodiments, the elastic wire 121 in the support segment 120 may also be wavy, such as S-shaped or non-S-shaped.

[0055] Preferably, the anchoring device 100 further includes a fixing portion 130 connected to at least a portion of the elastic wires 121 at the other end away from the anchoring section 110. That is, the fixing portion 130 can be connected to all or only a portion of the elastic wires 121, and is used to be positioned within the predetermined chamber. This configuration ensures that the elastic wires 121 connected to the fixing portion 130 do not deform or move during the cardiac cycle, or only undergo minor deformation and movement. This allows the elastic wires 121 connected to the fixing portion 130 to consistently apply elastic force to the predetermined chamber, thus guaranteeing that the supporting section 120 provides stable fixation and support to the anchoring section 110 throughout the cardiac cycle. This prevents the anchoring section 110 from moving inside the heart, which could lead to surgical failure. Furthermore, since the fixing part 130 can be connected to the end of the elastic wire 121 away from the anchoring section 110, it can prevent the end of the elastic wire 121 from directly contacting and scratching the inner wall of the predetermined chamber, thereby further ensuring the safety and reliability of the anchoring device 100 implantation. Of course, in other embodiments, the anchoring device 100 of the artificial heart valve may not have a fixing part, so that the ends of all elastic wires 121 away from the anchoring section 110 can extend freely.

[0056] In this embodiment, the fixing part 130 is a fixing ring. After the anchoring device 100 expands, the inner diameter of the fixing ring can be less than, equal to, or greater than the inner diameter of the first cavity 111 formed after the anchoring section 110 expands. Preferably, the inner diameter of the fixing part 130 after expansion is smaller than the inner diameter of the first cavity 111 after the anchoring section 110 expands, so that the fixing part 130 configured in this way will not hinder the periodic movement of the heart. In other embodiments, the fixing part 130 may also be a non-ring structure, for example, it may be configured as a fixing block or other structure connected to at least a portion of the elastic wire 121.

[0057] <Example 2>

[0058] For clarity, the anchoring device 200 in Embodiment 2 uses a different reference numeral than the anchoring device 100 in Embodiment 1. However, even with the different reference numerals, the embodiment of the anchoring device 100 in Embodiment 1 is equally applicable to the anchoring device 200 in Embodiment 2 for the same parts. The following description focuses primarily on the differences from Embodiment 1; for the same parts, please refer to Embodiment 1.

[0059] Reference Figure 2 and Figure 3 As shown, a preferred embodiment of the present invention provides an anchoring device 200 for an artificial heart valve. The anchoring device 200 includes an anchoring section 210 and a support section 220 axially connected to each other. The anchoring section 210 has an annular first cavity 211 capable of accommodating the artificial heart valve. The support section 220 is disposed on one side of the anchoring section 210 along its axial direction and includes at least two elastic wires 221 arranged sequentially along the circumference of the anchoring section 210. One end of each elastic wire 221 is connected to the anchoring section 210, and the other end extends away from the anchoring section 210. Preferably, the anchoring device 200 further includes a fixing part 230. The implementation of the fixing part 230 is described in Embodiment 1 and will not be repeated here.

[0060] The anchoring device 200 in this embodiment is more elongated and flatter than the anchoring device 100 in Embodiment 1. That is, the axial height H of the anchoring device 200 after expansion is greater. This configuration makes the axial height H of the support segment 220 after expansion greater than the axial height of the predetermined cavity in the axial direction of the anchoring device 200. That is, the support segment 220 is interference-fitted with the predetermined cavity in the axial direction. Since the anchoring segment 210 is in contact with the original valve annulus and cannot continue to move, the fixing part 230 can apply elastic force to the predetermined cavity in the axial direction, thereby making the support segment 220 more firmly connected to the predetermined cavity, while ensuring that the anchoring segment 210 can be better fixed at the implantation position.

[0061] Reference Figure 2As shown, in the radial direction of the anchoring device 200, the maximum outer contour of the expanded support section 220 in this embodiment may not contact the predetermined chamber to form an interference fit. Therefore, the size of the maximum outer diameter D2 of the expanded support section 220 is not limited. In this case, if the elastic wire 221 is arc-shaped, the bending radius may be the same as or different from the bending radius of the elastic wire 121 in Embodiment 1. Preferably, the bending radius of the elastic wire 221 in this embodiment is smaller. With this setting, during the cardiac cycle, the elastic wire 221 interferes with or does not interfere with the cardiac movement, thus ensuring the normal periodic movement of the heart and preventing deformation and movement of the elastic wire 221 due to the cardiac movement, further ensuring the anchoring force of the anchoring device 200. In other embodiments, in the radial direction of the anchoring section 210, the maximum outer contour of the expanded support section 220 in this embodiment may also contact the predetermined chamber to form an interference fit. In this case, the bending radius of the elastic wire 221 is relatively large.

[0062] See also Figure 5 This invention also provides an artificial heart valve 400. The artificial heart valve 400 can adopt an existing structure, specifically including an outflow segment 410 and a valve annulus segment 420 connected to each other. In some cases, the artificial heart valve also includes a flange segment 430. The outflow segment 410, valve annulus segment 420, and flange segment 430 are axially connected in sequence, and after the artificial heart valve expands, the inner diameter of the flange segment 430 is larger than the inner diameter of the valve annulus segment 420. However, this application does not limit the shape of the artificial heart valve 400. The shape of the artificial heart valve 400 can be any shape, such as cylindrical, conical, or with a waist-shaped design.

[0063] To enable the implantation of an artificial heart valve 400 with a flange segment 430 within the anchoring device 200, see [reference needed]. Figure 3 As shown, the elastic wire 221 in this embodiment includes a clearance section 222. The clearance sections 222 on all the elastic wires 221 collectively define a second cavity (not labeled). The second cavity is used to accommodate at least a portion of the artificial heart valve 400 (e.g., the flange section 430 of the artificial heart valve 400). After the anchoring device 200 expands, the inner diameter of the second cavity is larger than the inner diameter of the first cavity 211, so as to avoid interference between the anchoring device 200 and the flange section 430 of the artificial heart valve 400, which could lead to damage or displacement of the artificial heart valve 400, thereby preventing surgical failure and avoiding endangering the patient's life. Of course, when the implanted artificial heart valve 400 does not include the flange section 430, the clearance section 222 may not be provided on the elastic wire 221.

[0064] <Example 3>

[0065] For clarity, the anchoring device 300 in Embodiment 3 uses a different reference numeral than the anchoring device 100 in Embodiment 1. However, even with the different reference numerals, the embodiment of the anchoring device 100 in Embodiment 1 is equally applicable to the anchoring device 300 in Embodiment 3 for the same parts. The following description focuses primarily on the differences from Embodiment 1; for the same parts, please refer to Embodiment 1.

[0066] See Figure 4 As shown, a preferred embodiment of the present invention provides an anchoring device 300 for an artificial heart valve. The anchoring device 300 includes an anchoring section 310 and a support section 320 that are axially connected to each other. The anchoring section 310 has a first cavity 311 capable of accommodating the artificial heart valve. The support section 320 is disposed on one side of the anchoring section 310 along the axial direction. The support section 320 includes at least two elastic wires 321 arranged sequentially along the circumference of the anchoring section 310. One end of each elastic wire 321 is connected to the anchoring section 310, and the other end extends away from the anchoring section 310.

[0067] Unlike Embodiment 1, the support section 320 in this embodiment includes six elastic wires 321. The six elastic wires 321 are symmetrically arranged about the axis of the anchoring section 310 to achieve automatic positioning after the anchoring device 300 is released. In Embodiment 1, the number of elastic wires 121 is four. A larger number of elastic wires 121 can further enhance the anchoring force of the support section 320.

[0068] The difference from Embodiment 1 lies in the shape of the elastic wire 321 in this embodiment, which is wavy, like an S-shape. This allows the support section 320 to have a larger contact area when it comes into contact with the predetermined cavity, thereby enabling the support section 320 to be firmly connected to the predetermined cavity and thus better supporting and fixing the anchoring section 310. In this application, the number of bends of the elastic wire 321 is not limited; the elastic wire 321 can be bent any number of times before connecting to the anchoring section 310.

[0069] Reference Figure 4 As shown, in this embodiment, in the radial direction of the anchoring device 300, the maximum outer diameter D3 of all expanded support segments 320 is greater than the inner diameter of the portion where the predetermined cavity contacts the support segment 320. This arrangement allows the support segment 320 to have an interference fit with the predetermined cavity in the radial direction, thereby further strengthening the connection between the support segment 320 and the predetermined cavity. Furthermore, in this embodiment, the outer contour formed by the elastic wire 321 in the support segment 320 can be spherical or cylindrical. A spherical shape is preferred, as this allows the outer contour of the elastic wire 321 to better approximate the shape of the predetermined cavity, ensuring that each elastic wire 321 in the support segment 320 can contact the predetermined cavity and apply an elastic force to it.

[0070] Continue to refer to Figure 4 As shown, unlike Embodiment 1, the elastic wires 321 in the support segment 320 extend independently without intersecting each other, and the top of the elastic wires 321 has no fixing part. This allows each elastic wire 321 to move independently with the periodic movement of the heart when in contact with the predetermined chamber, thus enabling the elastic wires 321 to better adapt to various shapes of the predetermined chamber and ensuring that the support segment 320 is always firmly connected to the predetermined chamber. In addition, the design of having no fixing part at the end of the elastic wire 321 also helps to reduce the overall height of the anchoring device 300, thereby reducing the size of the anchoring device 300 after compression, simplifying the delivery device, and reducing the difficulty of implanting the anchoring device 300.

[0071] Reference Figure 4 and Figure 5 As shown, in one specific embodiment, to enable the implantation of an artificial heart valve 400 with a flange segment 430 within the anchoring device 300, each elastic wire 321 of the support segment 320 in this embodiment includes a clearance segment 322. The clearance segments 322 on all elastic wires 321 collectively define a second cavity (not labeled). This second cavity is used to accommodate at least a portion of the artificial heart valve 400 (e.g., it can accommodate the flange segment 430 of the artificial heart valve 400). Furthermore, after the anchoring device 300 expands, the inner diameter of the second cavity is larger than the inner diameter of the first cavity 311. The clearance segment 322 prevents interference between the anchoring device 300 and the flange segment 430 of the artificial heart valve 400, thus avoiding damage or movement of the artificial heart valve 400. Of course, when the implanted artificial heart valve 400 does not include the flange segment 430, the clearance segment 322 may not be provided on the elastic wire 321.

[0072] A preferred embodiment of the present invention also provides a method for delivering an anchoring device for an artificial heart valve. The working state of the anchoring device 300 can be switched between a contracted state and an expanded state. The method for delivering the anchoring device 300 includes:

[0073] The anchoring device 300 is retracted into the external device, and the retracted anchoring device 300 can enter the predetermined chamber with the external device; the anchoring section 310 is released and expanded; the external device is moved to move the expanded anchoring section 310 to a predetermined position; the support section 320 is released and expanded, and each elastic wire 321 in the expanded support section 320 can apply an elastic force to the inner wall of the predetermined chamber.

[0074] Furthermore, a preferred embodiment of the present invention also provides a method for delivering an artificial heart valve system, wherein the delivery method of the anchoring device 300 is as described above, wherein the working state of the artificial heart valve can also be switched between a systolic state and a dilated state, and the delivery method of the artificial heart valve includes:

[0075] After the anchoring device 300 is fully released, the artificial heart valve is retracted into the external device and moved with the external device into the first cavity 311 of the anchoring device 300; the artificial heart valve is released and radially expanded, and the anchoring segment 310 applies an anchoring force to the expanded artificial heart valve to anchor it at a predetermined position. It should be understood that the predetermined position in this document refers to the implantation location of the anchoring segment 310; in this embodiment, the predetermined position refers to the location of the original valve annulus. The external device in this document refers to a device capable of carrying the compressed anchoring device within a predetermined object (e.g., the human heart); in this embodiment, the external device refers to a delivery system for the anchoring device or the artificial heart valve.

[0076] See Figure 5 As shown, in this embodiment, the anchoring device 300 can be implanted into the left atrium LA, and the artificial heart valve 400 can be released into the first cavity 311 of the anchoring device 300 to replace and replace the natural mitral valve.

[0077] The following example of mitral valve replacement surgery illustrates the implantation process of the anchoring device 300 and the artificial heart valve 400:

[0078] Reference Figure 5 As shown, the anchoring device 300 can be delivered to the left atrium (LA) via the interatrial septum or apex through the delivery system. After implantation, the anchoring segment 310 and support segment 320 of the anchoring device 300 can be released at any position in the left atrium (LA). Because the support segment 320 is symmetrically arranged about the axis of the anchoring segment 310, the anchoring segment 310 can automatically move to the original valve annulus position after release, and each elastic wire 321 of the support segment 320 can automatically contact the inner wall of the left atrium (LA) and apply elastic force to the left atrium (LA). After the support segment 320 is fully released, the operator can withdraw the delivery system to complete the implantation of the anchoring device 300. After the anchoring device 300 is implanted, the implantation of the artificial heart valve 400 begins. Figure 5The artificial heart valve 400 includes an outflow segment 410, a valve annulus segment 420, and a flange segment 430 connected axially in sequence. After the artificial heart valve 400 is expanded, the inner diameters of the outflow segment 410 and the flange segment 430 are both larger than the inner diameter of the valve annulus segment 420. During implantation, the artificial heart valve 400 can be delivered to the left atrium LA via the interatrial septum, inferior vena cava, apex of the heart, or other pathways through the delivery system. The outflow segment 410 is placed in the left ventricle LV, the flange segment 430 is placed in the left atrium LA, and the valve annulus segment 420 is placed in the first lumen 311 of the anchoring segment 310. After the artificial heart valve 400 is implanted, the artificial heart valve 400 is expanded in diameter by balloon expansion or by self-expanding sheath descaling. During this expansion, the anchoring segment 310 in the anchoring device 300 will undergo elastic or plastic deformation. When the anchoring segment 310 deforms, it can adapt to the shape of the valve annulus segment 420 in the artificial heart valve 400 and fully fix and seal with the valve annulus segment 420. Thus, the anchoring device 300 and the artificial heart valve 400 are fixedly connected as a whole, and the artificial heart valve 400 is anchored at the original valve annulus position through the anchoring device 300.

[0079] Furthermore, since the inner diameters of the outflow segment 410 and the flange segment 430 are both larger than the inner diameter of the annulus segment 420, after the artificial heart valve 400 is enlarged, the flange segment 430 can be located in the second cavity of the anchoring device 300 in the left atrium (LA), and the outflow segment 410 can be located in the left ventricle (LV). At this time, the larger-radius outflow segment 410 and flange segment 430 can axially limit the annulus segment 420 of the artificial heart valve 400, ensuring that the annulus segment 420 can only be located at the position of the anchoring segment 310, thus ensuring that the artificial heart valve 400 cannot move axially after implantation. After the artificial heart valve 400 is fully enlarged, the operator can withdraw the delivery system after confirming that the artificial heart valve 400 and the anchoring device 300 are firmly implanted in the set position, thereby completing the implantation surgery of the artificial heart valve 400 and the anchoring device 300.

[0080] It should also be understood that the implantation process of the anchoring device 100 in Embodiment 1 and the anchoring device 200 and artificial heart valve 400 in Embodiment 2 can be referred to Embodiment 3, and will not be described in detail hereafter. In addition, the artificial heart valve system provided in the embodiments of the present invention may include the anchoring device provided in any of the embodiments.

[0081] In summary, the anchoring device and artificial heart valve system provided by this invention can fix the artificial heart valve to the heart valve annulus through the anchoring device. In specific implementation, the anchoring section of the anchoring device is set at the position of the native valve annulus, and the anchoring section is fixed by anchoring the support section in the atrium or ventricle. In this method, since the anchoring device only sets the support section on one axial side of the anchoring section, the support section does not need to cross the native valve annulus, thereby effectively preventing paravalvular leakage. At the same time, this anchoring method also avoids damage to the native valve leaflet or compression of the native valve annulus tissue. The surgery has good safety and reliability and is beneficial to the patient's postoperative recovery.

[0082] The artificial heart valve anchoring device provided by this invention achieves anchoring solely through the elasticity of the support segment and the interference fit between it and the atrium or ventricle, and through the interference fit between the first cavity of the anchoring segment and the artificial heart valve. This method results in a simple structure, and the anchoring segment can be automatically moved to the desired implantation position by releasing it from any position in the atrium or ventricle during implantation. This simplifies the implantation process of the anchoring device, reduces the difficulty of implantation, and improves the reliability and convenience of artificial heart valve surgery.

[0083] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. An anchoring device for an artificial heart valve, characterized in that, It includes an anchoring section and a support section that are axially connected to each other; the anchoring section has an annular first cavity capable of accommodating an artificial heart valve, and is adapted to the external contour of the artificial heart valve when the anchoring section is deformed by force, so as to apply an anchoring force to the artificial heart valve; the anchoring section is a coil structure made of wire, and the coil structure has at least one coil turn. The support section is disposed on one side of the anchoring section along the axial direction. The support section includes at least two elastic wires arranged sequentially along the circumference of the anchoring section. One end of each elastic wire is connected to the anchoring section, and the other end extends away from the anchoring section. The elastic wires in the support section do not intersect and extend independently. Each elastic wire can move independently when it comes into contact with a predetermined cavity of a predetermined object. The maximum outer diameter of the expanded support section is greater than the inner diameter of the part of the predetermined cavity that contacts the support section. The anchoring device is configured such that the anchoring section is disposed at the petal ring of the predetermined object, and the support section is disposed in the predetermined cavity of the predetermined object and can be fixed in the predetermined cavity by elastic force.

2. The anchoring device for an artificial heart valve as described in claim 1, characterized in that, The elastic filament has at least a curved shape in its outline along its extension direction.

3. The anchoring device for an artificial heart valve as described in claim 2, characterized in that, The elastic filament has at least a portion of its outline along its extension direction in an arc or wavy shape.

4. The anchoring device for an artificial heart valve as described in claim 2, characterized in that, The elastic wire includes clearance sections, and the clearance sections on all the elastic wires together define a second cavity for accommodating at least a portion of the artificial heart valve, and when the anchoring device expands, the inner diameter of the second cavity is larger than the inner diameter of the first cavity.

5. The anchoring device for an artificial heart valve as described in any one of claims 1-4, characterized in that, All of the elastic wires are evenly distributed circumferentially along the anchoring section.

6. An artificial heart valve system, characterized in that, The invention includes an artificial heart valve and an anchoring device for the artificial heart valve as described in any one of claims 1-5, wherein the artificial heart valve is to be housed in the anchoring device and fixed in a predetermined object by the anchoring device.

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