Artificial heart valve and medical device

Abstract

The present invention relates to an artificial heart valve and a medical device, comprising a valve support and an anchoring portion, wherein the valve support has a body section and a skirt section at an outflow end; a valve leaf section is arranged in the body section; the skirt section has a flange at the edge of one side of the outflow end; the anchoring portion comprises an atrial support portion and a joint portion; the anchoring portion is made of at least one spherical spiral elastic wire; the anchoring portion can be elastically deformed at least radially and axially to conform to the shape change of the atrium; the valve support is arranged in a space surrounded by the anchoring portion, and the joint portion is connected to the flange. Since the anchoring portion has better elastic deformation ability in radial and axial directions, the overall compliance of the artificial heart valve is greatly improved, so that it can ensure that the artificial valve is effectively fixed in the atrium and better conform to the normal physiological function of the atrium.

Description

Technical Field

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

[0002] Heart valves are membrane-like structures that can be opened and closed in the organs of humans or certain animals. There are four valves in everyone's heart, namely the aortic valve connecting the left ventricle and the aorta, the pulmonary valve connecting the right ventricle and the pulmonary artery, the mitral valve connecting the left atrium and the left ventricle, and the tricuspid valve connecting the right atrium and the right ventricle. They all act as one-way valves, so that blood can only flow from one direction to another and cannot flow back. Mitral regurgitation can lead to myocardial remodeling, progressive ventricular enlargement, and ultimately heart failure. In the prior art, transcatheter mitral valve replacement (TMVR) surgery has emerged, which uses a catheter intervention method to compress the artificial valve into the delivery system outside the body, deliver it to the human mitral valve ring, and release and fix 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, has less trauma, and the patient recovers quickly. The hemodynamic indicators of patients after surgery can be significantly improved. However, this method will destroy the natural valve ring tissue of the human body and is an irreversible replacement surgery.

[0003] In the art, there has emerged an artificial heart valve in which a valve stent is designed to be spherical so as to occupy the atrial space for anchoring. This artificial heart valve is positioned as a whole on the natural valve ring tissue of the human body after implantation, and does not affect the normal function of the natural valve leaflets. Furthermore, since the valve stent does not enter the ventricle, it will not cause ventricular outflow tract obstruction.

[0004] However, due to the different sizes of human atria, it is necessary to design a variety of different specifications of such spherical artificial heart valves according to the specific size of the atria, which has low adjustment flexibility. At the same time, compared with conventional valve stents, the existing spherical valve stents use a large number of metal struts, which increases the probability of thrombosis, and the compliance of the stent is poor, and its shape cannot fully match the normal movement requirements of the heart. In addition, the valve stent of such spherical artificial heart valves is fixed to the metal stent as a whole, and it is impossible to achieve precise customization according to the size of the human atria. Summary of the invention

[0005] The invention discloses an artificial heart valve and a medical device, aiming to solve the technical problems existing in the prior art.

[0006] The present invention adopts the following technical scheme: a highly compliant artificial heart valve, comprising: a valve stent, the valve stent having a body section and a skirt section at the outflow end; a valve leaf section is arranged in the body section; the skirt section has a flange at the edge of one side of the outflow end;

[0007] An anchoring portion, comprising an atrial support portion and a joint portion; the anchoring portion is made of at least one spherical spiral elastic wire; the anchoring portion can be elastically deformed at least in radial and axial directions to conform to the shape change of the atrium;

[0008] The valve stent is disposed in a space surrounded by the anchoring portion, and the engaging portion is connected to the flange.

[0009] As a preferred technical solution, the joint portion is fixedly connected to the flange.

[0010] As a preferred technical solution, the fixing method is preferably welding, crimping, or riveting.

[0011] As a preferred technical solution, the engaging portion is detachably connected to the flange.

[0012] As a preferred technical solution, the detachable connection method is preferably attachment, snap-on connection, or plug-in connection.

[0013] As a preferred technical solution, the flange has at least one first connection mechanism, and the engaging portion of the anchoring portion has at least one second connection mechanism matching the first connection mechanism.

[0014] As a preferred technical solution, the first connecting mechanism is a fixing hole arranged on the flange, and the second connecting mechanism is an insert matching the fixing hole; the insert has a locking mechanism to prevent it from coming out.

[0015] As a preferred technical solution, the joint portion of the anchoring portion has a higher elastic coefficient than that of the atrial supporting portion.

[0016] As a preferred technical solution, the joint portion and the atrial support portion are made of the same material, and the joint portion has a larger cross-sectional area than the atrial support portion;

[0017] Alternatively, the joint portion is made of a material having a higher elastic coefficient than the atrial support portion;

[0018] Alternatively, the junction portion has a higher density of turns of the elastic wire than the atrial support portion.

[0019] As a preferred technical solution, the anchoring portion further has a reinforcing sealing ring, which is a band-shaped portion extending outward from the elastic wire of a partial section of the joint portion.

[0020] As a preferred technical solution, the strip-shaped portion is made of biocompatible fabric.

[0021] As a preferred technical solution, the valve stent and the anchoring portion are both capable of contracting and expanding in the radial direction.

[0022] As a preferred technical solution, the skirt segment is a trumpet-shaped structure, the main body segment is roughly cylindrical, and the small-diameter end of the trumpet-shaped structure of the skirt segment is connected to the main body segment.

[0023] As a preferred technical solution, the skirt segment is composed of an arc-shaped connecting piece and a flange connected to the outer side thereof, and the arc-shaped connecting piece is in a broken line shape or a wave shape.

[0024] As a preferred technical solution, the flange is roughly in the shape of a circular broken line or wave, the number of arc-shaped connectors is the same as the number of wave crests or wave troughs of the flange, and each arc-shaped connector is connected to a corresponding wave crest or wave trough position.

[0025] As a preferred technical solution, a sealing film is provided on the outer surface of the valve stent.

[0026] As a preferred technical solution, the cross-section of the skirt segment is a D-shaped or elliptical closed loop surrounded by a plurality of convex curves.

[0027] As a preferred technical solution, the outer surface of the atrial support portion and / or the engaging portion has a plurality of barb structures, and the barb structures are used to pierce and engage with the valve ring tissue or the atrial inner wall tissue.

[0028] The present invention also provides a medical device for improving heart valve function, comprising:

[0029] At least one valve stent, the valve stent having a body section and a skirt section at the outflow end; the body section is provided with a valve leaf portion; the skirt section has a flange at an edge on one side of the outflow end; the flange has at least one first connecting mechanism;

[0030] A plurality of anchoring parts of different specifications, wherein the anchoring parts include an atrial support part and a joint part; the anchoring part is made of at least one spherical spiral elastic wire; the anchoring part can be elastically deformed at least in radial and axial directions to adapt to the shape change of the atrium; the joint part has at least one second connection mechanism matching the first connection mechanism;

[0031] The plurality of anchoring parts of different specifications have atrial supporting parts of different specifications, and the plurality of anchoring parts of different specifications all have coupling parts of the same specifications, so that the coupling parts are connected to the flange via a first connecting mechanism and a second connecting mechanism.

[0032] The technical solution adopted by the present invention can achieve the following beneficial effects: the artificial heart valve of the present invention is designed as a supra-annular valve, which is suitable for implantation into the left atrium or right atrium of the human heart via the femoral vein to replace the diseased mitral valve or tricuspid valve to perform functions. After implantation, it will not damage the normal physiological function of the human valve leaflets, and can also avoid outflow tract obstruction, which can reduce the probability of thrombosis. The anchoring part has a roughly spherical shape that matches the atrial structure. Since the anchoring part has better elastic deformation ability in radial and axial directions, the overall compliance of the artificial heart valve is greatly improved. Therefore, it can ensure that the artificial valve is effectively fixed in the atrium, while better complying with the normal physiological function of the atrium. In addition, the present invention can be precisely customized according to the size of the human atrium, such as selecting the specific shape and size of the valve support and the anchoring part according to the size of the valve ring and the atrium. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions explain the present invention and do not constitute improper limitations on the present invention. In the drawings:

[0034] Figure 1 This is a schematic diagram of the structure of an artificial heart valve disclosed in Example 1 of the present invention;

[0035] Figure 2 This is a plan view of the valve stent disclosed in Example 1 of the present invention.

[0036] Figure 3 It is a three-dimensional schematic diagram of the valve stent disclosed in Example 1 of the present invention;

[0037] Figure 4 It is a three-dimensional schematic diagram of the anchoring portion disclosed in Example 1 of the present invention;

[0038] Figure 5 It is a plan view of the anchoring portion disclosed in Example 1 of the present invention;

[0039] Figure 6 A top view of the valve stent disclosed in Example 1 of the present invention;

[0040] Figure 7 A schematic diagram of a valve stent with a sealing membrane disclosed in Example 1 of the present invention;

[0041] Figure 8 This is a schematic diagram of the artificial heart valve disclosed in Example 1 of the present invention being implanted into the atrium;

[0042] Fig. 9 It is a three-dimensional schematic diagram of the valve stent disclosed in Example 2 of the present invention;

[0043] Fig.10 It is a schematic plan view of the valve stent disclosed in Example 2 of the present invention;

[0044] Fig.11 A top view of the valve stent disclosed in Example 2 of the present invention;

[0045] Fig.12 is a three-dimensional schematic diagram of an artificial heart valve disclosed in Example 2 of the present invention;

[0046] Fig.13 It is a three-dimensional schematic diagram of the valve stent disclosed in Example 3 of the present invention;

[0047] Fig.14 A schematic plan view of the valve stent disclosed in Example 3 of the present invention;

[0048] Fig.15 This is a schematic diagram of a medical device for improving heart valve function disclosed in Example 4 of the present invention.

[0049] Description of reference numerals:

[0050] Atrium 1; human heart valve 2; valve ring 3; artificial heart valve 300; valve support 10, 10', 10"; anchoring portion 20; main body section 11; skirt section 12; metal mesh 111; connecting ear 112; leaflet portion 113; arc-shaped connecting members 121, 121', 121"; flanges 122, 122', 122"; first connecting mechanism 123; atrial support portion 21; joint portion 22; second connecting mechanism 221; sealing membrane 13; medical device 400 for improving heart valve function. DETAILED DESCRIPTION

[0051] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise.

[0052] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0053] As described herein, when the artificial heart valve is a mitral valve, the "outflow tract" refers to the left ventricular outflow tract, and when the artificial heart valve is a tricuspid valve, the "outflow tract" refers to the right ventricular outflow tract. As described herein, "spherical" or "substantially spherical" means that the outer side of the structure roughly passes through a spherical surface, rather than actually having a spherical surface, and those skilled in the art should understand that the spherical shape refers to a substantially spherical shape that matches the atrial space, rather than an absolute spherical surface.

[0054] Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0055] Example 1

[0056] This example 1 provides a highly compliant artificial heart valve 300 to solve the problems existing in the prior art. Figure 1-Figure 4 The artificial heart valve 300 includes a valve support 10 and an anchoring portion 20, and the anchoring portion 20 is generally spherical. For different patients, the shape and size of the atria may be different. Those skilled in the art should understand that the shape and size of the anchoring portion 20 can be adaptively changed according to the patient's condition.

[0057] The anchoring portion 20 is composed of at least one elastic wire wound in a spiral. The anchoring portion 20 has strong elasticity and at least radial and axial deformation capabilities, and can adapt to the shape changes of the atrium. The anchoring portion 20 can undergo axial elastic deformation, radial elastic deformation, and transverse elastic deformation. Among them, radial elastic deformation refers to the compression and tension deformation generated along the radial direction of the anchoring portion 20, and transverse elastic deformation refers to the deformation of the axis of the anchoring portion 20 due to the transverse application of force. Preferably, the anchoring portion 20 has weak axial deformation resistance and transverse deformation resistance, and has relatively strong radial deformation resistance.

[0058] according to Figure 5 The anchoring portion 20 has an atrial support portion 21 and a joint portion 22, and the side of the elastic wire close to the outflow end is the joint portion 22 ( Figure 5 The rest of the elastic thread is the atrial support portion 21 ( Figure 5 area above the dashed line).

[0059] according to Figure 2 The valve support 10 has a body section 11 and a skirt section 12 at the outflow end; according to Figure 6 The body section 11 is provided with a leaflet portion 113 ; the skirt section 12 has a flange 122 at the edge on the outflow end side.

[0060] The skirt section 12 is preferably a trumpet-shaped structure, and the small diameter end of the trumpet-shaped structure is connected to the body section 11, and the large diameter end of the trumpet-shaped structure is a flange 122. Preferably, the skirt section 12 is composed of an arc-shaped connecting member 121 and a flange 122 connected to the outside thereof. The flange 122 is annular, preferably a roughly circular broken line or wavy shape, so as to be easier to shrink or to help control the shrinkage diameter, so as to adapt to the size of the valve ring opening of different patients.

[0061] The body section 11 is substantially cylindrical and is surrounded by a metal mesh 111 , and the small diameter end of the trumpet-shaped structure of the skirt section 12 is connected to the body section 11 .

[0062] according to Figure 7 , a sealing film 13 is provided on the outer surface of the valve stent 10, preferably by suturing. The sealing film 13 covers all or most of the outer surfaces of the main body section 11 and the skirt section 12. The leaflet portion 113 is provided in the main body section 11, specifically, it is sewn on the support rod of the valve stent 10. The multiple leaflets of the leaflet portion 113 are completely wrapped in the sealing film 13. When the leaflets are closed, the backflowing blood is completely confined in the space formed by the sealing film and the leaflets in the closed state.

[0063] The lower end of the sealing film 13 is connected to the flange 122. To increase the connection strength, the sealing film 13 can be wrapped around the flange 122, folded in half and then sewn.

[0064] Preferably, the cross section of the skirt section 12 is a D-shaped or elliptical closed loop surrounded by two convex curves, or a D-shaped closed loop surrounded by three convex curves. Preferably, the flange 122 is also non-circular, preferably a D-shaped or elliptical closed loop surrounded by two convex curves, or a D-shaped closed loop surrounded by three convex curves.

[0065] like Figure 8 As described above, after the artificial heart valve 300 is at least placed in the atrium, the valve support 10 is disposed in the anchoring portion 20, and the joint portion 22 of the anchoring portion 20 is connected to the flange 122 of the valve support 10. Preferably, the atrial support portion 21 and the body segment 11 are not in direct contact, and a certain gap is left between the two, so that the atrial support portion 21 and the body segment 11 will not touch each other during the beating of the heart.

[0066] In one embodiment, the joint 22 and the flange 122 are fixedly connected. In this embodiment, the artificial heart valve 300 has the valve stent 10 and the anchoring portion 20 fixedly connected during the preparation process, and there is no need to perform a connection step during use, and the two are retracted into the catheter or cannula for standby use. The joint 22 of the anchoring portion 20 and the flange 122 of the valve stent 10 can be fixedly connected in a manner existing in the prior art, preferably by welding, crimping, or riveting. In a medical use scenario, since the anchoring portion 20 is elastic, the artificial heart valve 300 can better adapt to the atrial size of different patients to a certain extent.

[0067] In another embodiment, the joint 22 and the flange 122 are detachably connected. Those skilled in the art should understand that this detachable connection method can be selected from any existing applicable connection method, preferably attachment, clamping, and plugging. The artificial heart valve 300 is composed of a valve stent 10 and an anchoring portion 20. In a medical use scenario, an anchoring portion 20 of a certain specification is selected according to the shape and size of the patient's atrium. After being connected to the valve stent 10, it is retracted into a catheter or a cannula, and then the implantation surgery of the artificial heart valve 300 is performed.

[0068] Preferably, if Figure 3 As shown, the flange 122 has at least one first connection mechanism 123, preferably 2-4; the joint portion 22 of the anchoring portion 20 has at least one second connection mechanism 221 matching the first connection mechanism 123. As a preferred technical solution, the first connection mechanism 123 is a fixing hole provided on the flange, and the second connection mechanism 221 is an insert matching the fixing hole; the insert has a locking mechanism to prevent it from coming out, so as to avoid accidental separation of the valve support 10 and the anchoring portion 20 during the process of contraction, expansion, and placement after the artificial heart valve 300 is assembled. In this embodiment, when the sealing film 13 covers the flange 122, the sealing film 13 should reserve a window at the position of the fixing hole. It should be understood that the window will not destroy the sealing property of the sealing film 13 to blood.

[0069] Preferably, combined Figure 5 , the joint part 22 of the anchoring part 20 has a higher elastic coefficient than the atrial support part 21, or the joint part 22 has a higher mechanical strength than the atrial support part 21. The joint part 22 is anchored at the position of the valve ring 3. By enhancing the mechanical strength of the joint part 22, a greater clamping force can be applied to the valve ring tissue clamped between the spiral elastic wire of the atrial support part 21 and the flange of the skirt section 12, so as to appropriately reduce the size of the patient's valve ring tissue, improve the closing integrity of the human heart valve 2 (natural leaflet), further reduce the reflux of blood from the ventricle to the atrium, and enhance the treatment effect.

[0070] Preferably, the joint 22 and the atrial support portion 21 are made of the same material, and the joint 22 has a larger cross-sectional area than the atrial support portion 21 (not shown in the figure); preferably, the joint 22 and the atrial support portion 21 are made of the same metal pipe using a laser cutting process, and the joint 22 has a wider cutting width. In another embodiment, the joint 22 and the atrial support portion 21 are made of different materials and then connected to form the anchoring portion 20; specifically, the joint 22 is made of a material with a higher elastic coefficient than the atrial support portion 21, while maintaining the same or similar diameter or cross-sectional area.

[0071] Preferably, if Figure 5 As shown, the number of turns of the elastic wire wound on the joint 22 is higher than that on the atrial support part 21, thereby providing a higher mechanical strength per unit volume. After the artificial heart valve 300 is placed in the atrium, the anchoring part 20 firmly fixes the valve support 10 on the inflow end of the diseased human heart valve 2, and with the beating of the heart, the atrial support part 21 of the anchoring part 20 benefits from better radial and axial elastic deformation capabilities and provides better compliance, while providing a smaller reaction force to the atrial wall as possible while providing stable anchoring. The joint 22 of the anchoring part 20 benefits from higher mechanical strength, which ensures the radial stability of the valve support 10 and can apply a greater clamping force to the valve ring tissue.

[0072] Preferably, the joint 22 of the anchoring portion 20 also has a reinforced sealing ring (not shown in the drawings). Preferably, the reinforced sealing ring is a band-shaped portion extending outward from the elastic wire of a partial section of the joint, and the band-shaped portion is made of a biocompatible fabric. Preferably, 1 to 1.5 weeks of elastic wire at the end of the joint radially extend outward by 1 to 15 mm to form a band-shaped portion. The biocompatible fabric is preferably but not limited to any one of PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), e-PTFE or PU (polyurethane) or a combination of at least two of them. In a preferred embodiment, the reinforced sealing ring and the sealing membrane 13 are made of the same material, or even formed as one piece.

[0073] Preferably, the valve stent 10 and the anchoring portion 20 can both contract and expand radially; before the implantation operation, the valve stent 10 and the anchoring portion 20 are in a contracted state; Figure 8 As shown, after the artificial heart valve 300 is pushed into place, a balloon catheter is used to expand the valve stent 10 and / or the anchoring portion 20, or the anchoring portion 20 can be elastically expanded.

[0074] Preferably, the outer surface of the atrial support portion 21 and / or the joint portion 22 has a plurality of barb structures, that is, the elastic wire forming the atrial support portion 21 and / or the joint portion 22 is provided with barb structures outwardly, and those skilled in the art should understand that the barb structures are provided outwardly in a direction away from the anchor portion 20, but the specific direction of the barbs is not limited to the radial direction. The barb structures are used to penetrate and engage the valve ring tissue or the atrial inner wall tissue to provide a better and more stable anchoring effect.

[0075] Preferably, the artificial heart valve 300 also has a plurality of developing points. After the heart valve stent is implanted in the human body, usually, the doctor needs to determine whether the implantation position is accurate through the developing points set on the implanted artificial heart valve 300. Moreover, since the heart valve is a three-dimensional structure, it is usually necessary to determine whether its spatial position is accurate, so it is necessary to determine whether its spatial position is accurate through the positions of a plurality of developing points. In order to facilitate the determination of the spatial position of the heart valve stent after implantation, the flange 122 of the skirt section 12 of the heart valve stent of this embodiment is provided with two or three developing points. The skirt section 12 is a D-shaped structure as an example for explanation. When the cross section is a D-shaped closed loop composed of a first convex curve and a second convex curve, the curvature of the first convex curve is greater than the curvature of the second convex curve, and the first convex curve is a symmetrical curve, two or three developing points are provided in the flange section corresponding to the first convex curve.

[0076] Preferably, multiple developing points are also provided on the anchoring portion 20, preferably at multiple positions of the body segment 11 and / or the skirt segment 12, for example, 2-3 developing points are provided at the maximum diameter of the body segment 11, to assist doctors in checking the matching effect of the anchoring portion 20 with the atrium into which it is placed, such as whether each position of the anchoring portion 20 is stably anchored with the atrium wall. At the same time, it can be checked whether the connection relationship or matching relationship between the anchoring portion 20 and the valve stent 10 is as expected.

[0077] Preferably, the number and position of the multiple developing points on the anchoring portion 20 match the multiple developing points on the flange 122. For example, if two developing points are provided on the flange 122, two developing points are also provided on the anchoring portion 20, and the connecting lines of the two developing points are parallel to each other.

[0078] according to Figure 3 Preferably, a plurality of connecting ears 112 are provided at the top of the main body section 11 for cooperating with the artificial valve unhooking mechanism and the artificial valve delivery device to complete the delivery of the artificial heart valve 300 .

[0079] Example 2

[0080] according to Figure 9-12, this embodiment 2 provides a preferred structure of the valve stent 10'. The valve stent 10' has a main body section and a skirt section at the outflow end; a leaflet portion is arranged in the main body section; and a flange 122' is provided on the edge of the skirt section on one side of the outflow end. The skirt section is a trumpet-shaped structure, and the small diameter end of the trumpet-shaped structure is connected to the main body section, and the large diameter end of the trumpet-shaped structure is a flange 122'. The skirt section is composed of an arc-shaped connector 121' and a flange 122' connected to its outer side. Different from embodiment 1, the arc-shaped connector 121' is in a zigzag shape or a wavy shape, specifically, the configuration when unfolded into a plane is in a zigzag shape or a wavy shape, and the structure is then bent into an arc as a whole. The arc-shaped connector 121' is preferably as follows Figure 9-11 The semicircular wave shape described in , comprises 3-5 semicircular bends, preferably 4 semicircular bends.

[0081] The flange 122 is in the shape of a circular ring and can be elastically deformed so as to more easily cooperate with the deformation of the arc-shaped connecting piece 121 ′ to adapt to the shape and size of the valve ring of different patients.

[0082] Fig.12 This is the state where the valve stent 10 ′ is connected to the anchoring portion 20 .

[0083] Example 3

[0084] according to Figure 13-14 , this embodiment 2 provides a preferred structure of a valve stent 10". The valve stent 10" has a main body section and a skirt section at the outflow end; a leaflet portion is arranged in the main body section; the edge of the skirt section on one side of the outflow end has a flange 122". The skirt section is a trumpet-shaped structure, and the small diameter end of the trumpet-shaped structure is connected to the main body section, and the large diameter end of the trumpet-shaped structure is the flange 122". The skirt section is composed of an arc-shaped connector 121" and a flange 122" connected to its outer side. The arc-shaped connector 121" is in a broken line shape or a wavy shape. The arc-shaped connector 121" is preferably as follows Figure 9-11 The semicircular wave shape described in the embodiment 2 is different from the embodiment 2 in that the flange 122" is roughly annular in shape or wave shape, so as to be easier to shrink or to help control the shrinkage diameter. Fig.12 The flange 122" is preferably in a roughly circular shape composed of sinusoidal wave lines. The number of arc-shaped connectors 121" is the same as the number of wave crests or wave troughs of the flange 122". Preferably, each arc-shaped connector 121" is connected to a corresponding wave trough position of the flange 122" to achieve the most ideal shrinkage effect.

[0085] Example 4

[0086] In a medical scenario, patients have different ages, genders, heights, weights, pathological conditions, etc., so the atria of the patients may have different shapes and / or sizes. Fig.15As shown, this embodiment provides a medical device 400 for improving the function of a heart valve. When the joint 12 is detachably connected to the flange 122, the medical device 400 provides a combination of a plurality of different specifications of valve stents 10 and a plurality of different specifications of anchoring parts 20. The doctor selects the best-fitting valve stent 10 and anchoring part 20 based on the data of the patient's atrium obtained by the test.

[0087] Fig.15 The medical device 400 for improving the function of a heart valve can be considered as a set of an artificial heart valve 300, which includes:

[0088] At least one valve stent 10, the valve stent 10 has a body section 11 and a skirt section 12 at the outflow end; the body section 11 is provided with a leaflet portion 113; the skirt section 12 has a flange 122 at the edge of the outflow end; the flange 122 has at least one first connecting mechanism 123; in a preferred embodiment, only one specification of valve stent 10 is provided. In a preferred embodiment, valve stents 10 of multiple specifications can be provided, and the best fitting one is selected according to different valve rings.

[0089] A plurality of anchoring parts 20A, 20B, 20C of different specifications, each of which is roughly spherical and is formed by spirally winding at least one elastic wire; the anchoring parts 20A, 20B, 20C have at least radial and axial deformation capabilities and can adapt to the shape change of the atrium; the anchoring parts 20A, 20B, 20C have an atrial support part 21 and a joint part 22; the joint part 22 has at least one second connection mechanism 221 matching the first connection mechanism 123;

[0090] A plurality of anchoring parts 20A, 20B, 20C of different specifications have atrial support parts 21 of different specifications, such as Fig. 9 As shown, the atrial support parts 21 of the three anchoring parts have three sets of different radial and axial parameters, namely W1 and H1, W2 and H2, W3 and H3, respectively, and multiple anchoring parts 20A, 20B, 20C of different specifications all have the same specification of the connecting part 22, so that the connecting part 22 is connected to the flange 122 via the first connecting mechanism 123 and the second connecting mechanism 221.

[0091] The specific features of the valve stent 10 and the anchoring portion 20 in Example 4 refer to the description in Examples 1-3 and will not be repeated here.

[0092] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. An artificial heart valve, characterized in that: include: - a valve stent, the valve stent comprising a body section and a skirt section at the outflow end; a valve leaflet portion is arranged in the body section; and an edge of the skirt section at one side of the outflow end has a flange; - Anchoring portion, comprising an atrial support portion and a joint portion; the anchoring portion is made of at least one elastic wire in a spherical spiral; the anchoring portion is capable of elastic deformation in at least radial and axial directions to conform to the shape change of the atrium; The valve support is arranged in the space surrounded by the anchoring portion, and the joint portion is fixedly connected or detachably connected to the flange; The joint has higher mechanical strength than the atrial support portion, so that the joint can apply a greater clamping force to the annular tissue clamped between the spiral elastic wire of the atrial support portion and the flange of the skirt segment, thereby reducing the size of the patient's annular tissue.

2. The artificial heart valve according to claim 1, characterized in that: The fixing method is welding, pressing or riveting.

3. The artificial heart valve according to claim 1, characterized in that: The detachable connection is by attachment.

4. The artificial heart valve according to claim 1, characterized in that: The detachable connection is in the form of a snap connection.

5. The artificial heart valve according to claim 1, characterized in that: The detachable connection is in the form of plug-in.

6. The artificial heart valve according to any one of claims 3 to 5, characterized in that: The flange has at least one first connection mechanism, and the engaging portion of the anchoring portion has at least one second connection mechanism matching the first connection mechanism.

7. The artificial heart valve according to claim 6, characterized in that: The first connection mechanism is a fixing hole arranged on the flange, and the second connection mechanism is an insert matching the fixing hole; the insert has a locking mechanism to prevent it from coming out.

8. The artificial heart valve according to claim 1, characterized in that: The engagement portion of the anchoring portion has a higher modulus of elasticity than the atrial support portion.

9. The artificial heart valve according to claim 8, characterized in that: The joint portion and the atrial support portion are made of the same material, and the joint portion has a larger cross-sectional area than the atrial support portion; Alternatively, the joint portion is made of a material having a higher elastic coefficient than the atrial support portion; Alternatively, the junction portion has a higher density of turns of the elastic wire than the atrial support portion.

10. The artificial heart valve according to claim 1, characterized in that: The anchoring portion also has a reinforcing sealing ring which is a band-shaped portion extending outwardly from the elastic wire of a partial section of the engaging portion.

11. The artificial heart valve according to claim 10, characterized in that: The strip-shaped portion is made of biocompatible fabric.

12. The artificial heart valve according to claim 1, characterized in that: The valve support and the anchoring portion can both contract and expand radially.

13. The artificial heart valve according to claim 1, characterized in that: The skirt section is a trumpet-shaped structure, the main body section is substantially cylindrical, and the small-diameter end of the trumpet-shaped structure of the skirt section is connected to the main body section.

14. The artificial heart valve according to claim 1, characterized in that: The skirt section is composed of an arc-shaped connecting piece and a flange connected to the outer side thereof, and the arc-shaped connecting piece is in a broken line shape or a wave shape.

15. The artificial heart valve according to claim 14, characterized in that: The flange is roughly in the shape of a broken line or a wave in a circular ring. The number of arc-shaped connecting members is the same as the number of wave crests or wave troughs of the flange, and each arc-shaped connecting member is connected to a corresponding wave crest or wave trough position.

16. The artificial heart valve according to claim 1, characterized in that: A sealing film is arranged on the outer surface of the valve support.

17. The artificial heart valve according to claim 1, characterized in that: The cross section of the skirt section is a D-shaped or elliptical closed loop surrounded by a plurality of convex curves.

18. The artificial heart valve according to claim 1, characterized in that: The outer surface of the atrial support portion and / or the engaging portion has a plurality of barb structures, and the barb structures are used to penetrate into and engage with the valve ring tissue or the atrial inner wall tissue.

19. A medical device for improving heart valve function, characterized in that: Also includes: - at least one valve support, the valve support having a body section and a skirt section at the outflow end; the valve leaflet portion is arranged in the body section; The skirt section has a flange at the edge of the outflow end; the flange has at least one first connecting mechanism; - A plurality of anchoring parts of different specifications, wherein the anchoring parts include an atrial support part and a joint part; the anchoring part is made of at least one elastic wire in a spherical spiral; the anchoring part can be elastically deformed at least in the radial direction and the axial direction to adapt to the shape change of the atrium; the joint part has at least one second connection mechanism matching the first connection mechanism; the joint part has a higher mechanical strength than the atrial support part, so that the joint part can apply a greater clamping force to the valve ring tissue clamped between the spiral elastic wire of the atrial support part and the flange of the skirt section, thereby reducing the size of the patient's valve ring tissue; The plurality of anchoring parts of different specifications have atrial supporting parts of different specifications, and the plurality of anchoring parts of different specifications all have coupling parts of the same specifications, so that the coupling part and the flange are detachably connected via a first connecting mechanism and a second connecting mechanism.

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