Transcatheter heart valve replacement system

Abstract

The present application relates to a kind of trans-catheter heart valve replacement system, which is composed of artificial heart valve and valve anchoring device, wherein the valve anchoring device can be wrapped outside valve chordae tendineae, while capturing native valve leaflet, providing positioning point for subsequent implantation of artificial heart valve;Artificial heart valve can be implanted in heart, and replace the physiological function of native valve.The valve anchoring device and artificial heart valve can be matched and positioned, in order to prevent the two from being too tight and continuous extrusion, friction and causing chordae tendineae rupture, there are two kinds of cooperation between them: the first cooperation state, can let artificial heart valve and valve anchoring device abut each other, ensure the stability of structure and position when the two are matched with each other;Second cooperation state, there is gap between artificial heart valve and valve anchoring device at this time, so that native valve leaflet or chordae tendineae can pass through, to reduce the contact area between valve replacement system and chordae tendineae as much as possible, avoid extruding chordae tendineae.

Description

Technical Field

[0001] This invention relates to the field of medical devices for cardiac interventional procedures, and more particularly to a transcatheter heart valve replacement system. Background Technology

[0002] In recent years, the incidence of valvular heart disease has increased significantly, with studies showing that the incidence rate in the elderly population over 75 years old is as high as 13.3%. Surgical treatment remains the preferred treatment for patients with severe valvular disease. In recent years, transcatheter valve replacement / repair has gradually matured and become widely used.

[0003] Compared to traditional valve products, a current transcatheter heart valve replacement system consists of two parts: an artificial valve and an anchoring device. The system works as follows: the anchoring device (catching ring) is implanted transcatheterically beneath the patient's valve annulus. The catching ring passes through the gap between the chordae tendineae and the ventricular wall beneath the valve annulus and is secured to the patient's valve annulus by wrapping around the chordae tendineae, forming a valve anchoring device. The artificial valve is implanted transcatheterically into the patient's heart and is released and deployed within the anchoring device (catching ring). The artificial valve is then fixed within the anchoring device, ultimately replacing the patient's valve.

[0004] After the aforementioned transcatheter heart valve replacement system is implanted in the patient, the artificial valve and anchoring device fit tightly together circumferentially, trapping the patient's chordae tendineae and valve leaflets between them. With each heartbeat, the chordae tendineae are constantly compressed and rubbed against the implanted valve, potentially causing chordae tendineae rupture and displacement of the anchoring device and artificial valve.

[0005] Given the above shortcomings, how to redesign the position or structural relationship between artificial valves and anchoring devices, while ensuring a stable connection between the two and the chordae tendineae, and avoiding compression or friction on the chordae tendineae, has become an urgent technical problem to be solved. Summary of the Invention

[0006] This invention discloses a transcatheter heart valve replacement system, which aims to solve the technical problems existing in the prior art.

[0007] The present invention adopts the following technical solution:

[0008] A transcatheter heart valve replacement system is provided, including an artificial heart valve and a valve anchoring device;

[0009] The valve anchoring device includes a fixing part, which includes at least one annular member; the valve anchoring device can be positioned outside the native valve chordae tendineae and conforms to changes in the native valve annulus morphology;

[0010] Artificial heart valves include valve stents, at least a portion of which defines a flow channel for blood flow; artificial heart valves can be positioned medial to the native valve and replace the physiological functions of the native valve.

[0011] At least a portion of the valve stent mates with the annular member; the mate between the valve stent and the annular member includes a first mating state and a second mating state, which are circumferentially spaced apart.

[0012] The first fitting state is configured such that the valve stent and the annular component abut against each other, with an interference fit or an overfit;

[0013] The second mating configuration is as follows: there is a gap between the valve stent and the annular member, and the two are in a gap fit; the gap between them is used to accommodate the chordae tendineae or the original leaflets.

[0014] As a preferred technical solution, the valve stent includes a main body, and at least a portion of the main body cooperates with an annular member;

[0015] The outer periphery of the main body is provided with a protrusion, and / or the inner periphery of the annular member is provided with a recess;

[0016] The protrusion protrudes along the radial direction of the main body and is used to form a first mating state with the annular member; the area without the protrusion can form a second mating state with the annular member.

[0017] The recessed portion is recessed in the radial direction of the annular member to form a second mating state with the main body portion, while the area without the recessed portion can form a first mating state with the main body portion.

[0018] As a preferred technical solution, the outer periphery of the main body is provided with a protrusion, and the inner periphery of the annular component is provided with a recess; the protrusion and the recess are staggered in the circumferential direction.

[0019] As a preferred technical solution, the protrusion is arched and disposed on the outer periphery of the main body, and the inner surface of the protrusion is adapted to the outer periphery contour of the main body;

[0020] The arc length of the protrusion is not greater than half the circumference of the main body; the vertical length of the protrusion is not less than the vertical width of the fixed part.

[0021] As a preferred technical solution, the main body is provided with at least two protrusions, and the adjacent protrusions are arranged at equal or unequal intervals; the space between the adjacent protrusions is used to accommodate chordae tendineae or native leaflets.

[0022] As a preferred technical solution, the main body is provided with at least two protrusions; the protrusions are provided with equal or unequal wall thickness in the circumferential direction, and / or, the protrusions are provided with equal or unequal wall thickness in the axial direction.

[0023] As a preferred technical solution, the protrusion includes a rigid polymer material or a metal material, and is fixed to the main body by means of bonding, welding, hinge, fusion, riveting, or integral molding.

[0024] As a preferred technical solution, the recess is configured as a variable diameter section on the annular member, and the variable diameter section is waist-shaped; the gap between the variable diameter section and the main body is used to accommodate the tendineae or the original leaflets.

[0025] As a preferred technical solution, the annular component has at least two recesses, and adjacent recesses are spaced equidistantly or unequally.

[0026] As a preferred technical solution, the fixing part is provided with at least two annular components, and the recesses on adjacent annular components are positioned corresponding to each other.

[0027] As a preferred technical solution, the valve stent includes a main body;

[0028] In the cross-section of the main body and the fixed part, one is circular and the other is non-circular; the two are tangent in some sections and separate in some sections, and the separated area is used to accommodate the tendineae or the original leaflets.

[0029] As a preferred technical solution, the cross-section of the main body is circular, and the cross-section of the fixing part is elliptical, with two tangent points;

[0030] Alternatively, the cross-section of the main body is circular, and the cross-section of the fixing part is triangular ring-shaped, with three tangent points between them;

[0031] The gap between adjacent tangent points of the cross-sections of the main body and the fixation part is used to accommodate the tendineae or the original leaflets.

[0032] As a preferred technical solution, the cross-section of the main body is elliptical or D-shaped, and the cross-section of the fixing part is circular, with two tangent points; the gap between the tangent points is used to accommodate the tendineae or the original leaflets.

[0033] As a preferred technical solution, the valve stent is provided with a first connector, which is disposed on the outer surface of the protrusion or the outer surface of the main body, and the first connector has a tendency to extend toward the fixing part; the first connector may or may not pierce the original leaflet and cooperate with the annular component.

[0034] And / or, the fixing part is provided with a second connector, which tends to extend toward the main body; the second connector may or may not pierce the original leaflet and cooperate with the main body.

[0035] As a preferred technical solution, the first connector includes several anchor arms, which are disposed on the outside of the protrusion or the main body and extend radially outward;

[0036] The anchoring arm bends away from the direction of blood flow; or, the anchoring arm bends in the direction of blood flow.

[0037] As a preferred technical solution, the first connector includes several magnetic components, which are disposed on the outer peripheral surface of the protrusion or inside the protrusion near the outer peripheral surface.

[0038] As a preferred technical solution, the second connector includes several magnetic components, which are disposed on the outer surface of the fixing part or inside the part close to the outer surface.

[0039] As a preferred technical solution, the valve stent includes a main body and a skirt;

[0040] The skirt has a flange-shaped structure, and the small-diameter end of the skirt connects to the main body; the main body includes several interconnected polygonal grid structures.

[0041] As a preferred technical solution, the fixing part includes multiple annular components, with adjacent annular components connected end to end, forming a spiral structure.

[0042] As a preferred technical solution, the fixing part includes multiple annular components, each annular component being a closed ring, the multiple annular components being arranged axially parallel, and adjacent annular components being elastically connected.

[0043] The technical solution adopted in this invention can achieve the following beneficial effects:

[0044] (1) This invention provides a transcatheter heart valve replacement system, comprising an artificial heart valve and a valve anchoring device, wherein the valve anchoring device can surround the lateral side of the valve chordae tendineae, capturing the native valve leaflet while providing a positioning point for subsequent implantation of the artificial heart valve; the artificial heart valve can be implanted into the mitral or tricuspid valve and replace the physiological function of the native valve. The valve anchoring device and the artificial heart valve can cooperate with each other to avoid undesirable displacement of the artificial heart valve during the cardiac cycle due to tissue relaxation / contraction. To prevent chordae tendineae rupture due to excessive tightness and continuous compression and friction, there are two mating states between the valve anchoring device and the artificial heart valve: The first mating state allows the artificial heart valve and the valve anchoring device to abut against each other, with an over-fit or interference fit, ensuring the structural and positional stability of the valve anchoring device and the artificial heart valve when they are mated; the second mating state has a gap between the artificial heart valve and the valve anchoring device, allowing the native leaflet or chordae tendineae to pass through, minimizing the contact area between the valve replacement system and the chordae tendineae, and avoiding compression of the chordae tendineae, which could cause rupture.

[0045] (2) In some preferred embodiments of the present invention, the artificial heart valve includes a valve stent, and the main body of the valve stent is provided with a protrusion; the valve anchoring device includes a fixing part, the fixing part has one or more annular members, and the annular members are provided with a recess; the protrusion and the recess can be provided simultaneously, or only one of them can be provided, but when they are provided simultaneously, the protrusion and the recess are staggered; wherein, the gap between the circumferentially adjacent protrusions can be used to accommodate the original leaflet or chordae tendineae, and the gap between the recess itself and the valve stent can also be used to accommodate the original leaflet or chordae tendineae.

[0046] (3) In some preferred embodiments of the present invention, in the cross-section of the main body and the fixing part, one of them is circular and the other is non-circular, and it is necessary to ensure that the two are tangent in some sections and separate in some sections; the tangent point represents the first matching state, ensuring the stability of the structure and position when the valve anchoring device and the artificial heart valve are matched; the separation point represents the second matching state, avoiding compression of the chordae tendineae and causing its breakage.

[0047] (4) In some preferred embodiments of the present invention, a first connector is provided on the outside of the valve stent. The first connector may be an anchoring arm or a magnetic component. When the first connector is an anchoring arm, the anchoring arm may extend radially through the original leaflet and abut against the valve anchoring device, so that the two can be stably connected and the artificial heart valve cannot easily detach from the valve anchoring device. Even if the heart experiences or suffers a large-scale tremor, or the original valve develops organic lesions again, the replacement system of the present application can still function normally. When the first connector is a magnetic component, it is preferable to use the same magnetic component as that provided in the valve anchoring device, so as to provide both magnetic connection and greater friction force at the same time.

[0048] (5) In some preferred embodiments of the present invention, a second connector may be provided on the inner side of the valve anchoring device. The second connector may be an anchoring arm or a magnetic component. When the second connector is an anchoring arm, the anchoring arm may pierce the original leaflet radially inward, or may be further connected to the first connector on the artificial heart valve. When the first connector is a magnetic component, at least a portion of the artificial heart valve is also configured as a magnetic component or has ferromagnetism. In this case, the valve anchoring device and the artificial heart valve are magnetically connected.

[0049] (6) In a preferred embodiment of the present invention, the inflow end of the artificial heart valve is provided with a skirt portion, which is flange-shaped and has a rigid skeleton. A sealing membrane is sewn on its outer side to fill the gap between the artificial heart valve and the valve anchoring device, which can effectively prevent paravalvular leakage and reduce surgical risks. Attached Figure Description

[0050] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0051] Figure 1 This is a schematic diagram of the structure of an artificial heart valve in a preferred embodiment of the present invention, as disclosed in Embodiment 1 of the present invention;

[0052] Figure 2 This is a schematic diagram of the valve anchoring device in a preferred embodiment of the present invention disclosed in Embodiment 1;

[0053] Figure 3 This is a schematic diagram of the valve anchoring device in another preferred embodiment of the present invention disclosed in Embodiment 1;

[0054] Figure 4 This is a diagram showing the coordination state of the artificial heart valve and the valve anchoring device in a preferred embodiment of the present invention, as disclosed in Embodiment 1 of the present invention.

[0055] Figure 5 for Figure 4 Cross-sectional view;

[0056] Figure 6 This is a schematic diagram of the structure of an artificial heart valve in a preferred embodiment of the present invention, as disclosed in Embodiment 2 of the present invention;

[0057] Figure 7 This is a schematic diagram of the valve anchoring device in a preferred embodiment of the present invention, as disclosed in Embodiment 2 of the present invention;

[0058] Figure 8 This is a top view of a valve anchoring device in a preferred embodiment of Embodiment 2 of the present invention;

[0059] Figure 9 This is a diagram showing the coordination state of the artificial heart valve and the valve anchoring device in a preferred embodiment of Embodiment 2 of the present invention.

[0060] Figure 10 for Figure 9 A bottom view;

[0061] Figure 11 for Figure 9 Cross-sectional view;

[0062] Figure 12 This is a diagram showing the use of the valve anchoring device in the heart according to a preferred embodiment of the present invention, as disclosed in Embodiment 2 of the present invention.

[0063] Figure 13This is a diagram showing the intracardiac use of a heart valve replacement system in a preferred embodiment of Embodiment 2 of the present invention.

[0064] Figure 14 This is a cross-sectional view of the artificial heart valve and the valve anchoring device after being combined in a preferred embodiment of Embodiment 3 of the present invention;

[0065] Figure 15 This is a diagram showing the coordination state of the artificial heart valve and the valve anchoring device in a preferred embodiment of the present invention, as disclosed in Embodiment 4 of the present invention.

[0066] Figure 16 for Figure 15 Cross-sectional view;

[0067] Figure 17 This is a diagram showing the coordination state of the artificial heart valve and the valve anchoring device in a preferred embodiment of the present invention, as disclosed in Embodiment 5 of the present invention.

[0068] Figure 18 for Figure 17 Cross-sectional view.

[0069] Explanation of reference numerals in the attached figures:

[0070] Valve stent 100, main body 110, protrusion 120, anchoring arm 130, skirt 140;

[0071] Valve anchoring device 200, annular components 210, 210', elastic connector 220, recess 230;

[0072] Left atrium 300, left ventricle 400, native leaflet 500, chordae tendineae 600. Detailed Implementation

[0073] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0074] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or a magnetic connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0075] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0076] To address the problems existing in the prior art, embodiments of the present invention provide a transcatheter heart valve replacement system, which includes an artificial heart valve and a valve anchoring device 200; the valve anchoring device 200 includes a fixing part, the fixing part including at least one annular member 210; the valve anchoring device 200 can be positioned outside the native valve chordae tendineae 600 and conforms to changes in the morphology of the native valve annulus; the artificial heart valve includes a valve stent 100, at least a portion of the valve stent 100 defining a flow channel for blood flow; the artificial heart valve can be positioned inside the native valve and replace the native valve. The physiological function of the valve stent 100; at least a portion of the valve stent 100 cooperates with the annular member 210; the cooperation between the valve stent 100 and the annular member 210 includes a first cooperation state and a second cooperation state, which are circumferentially spaced apart; the first cooperation state is configured such that the valve stent 100 and the annular member 210 abut against each other, and the two are in an interference fit or an overfit; the second cooperation state is configured such that there is a gap between the valve stent 100 and the annular member 210, and the two are in a gap fit; the gap between the two is used to accommodate the chordae tendineae 600 or the original leaflet 500.

[0077] Example 1

[0078] To address the problems existing in the prior art, this embodiment provides a transcatheter heart valve replacement system that can be applied to any valve in the heart; for ease of explanation, this embodiment uses transcatheter mitral valve replacement as an example.

[0079] refer to Figures 1-5The heart valve replacement system includes an artificial heart valve and a valve anchoring device 200. The artificial heart valve includes at least a metal valve stent 100 and an artificial leaflet. The valve stent 100 has a body portion 110, within which a flow channel for blood flow is defined. The valve anchoring device 200 includes a fixing portion having one or more annular members 210 that can be implanted at the chordae tendineae 600 plexus of the mitral valve and can provide at least radial force to cooperate with and interact with the artificial heart valve implanted in the mitral valve. The cooperation of the two can reduce the size of the natural mitral valve and reduce mitral regurgitation. At the same time, the valve anchoring device 200 can securely anchor the position of the artificial heart valve, effectively preventing displacement of the artificial heart valve during myocardial movement.

[0080] Preferably, the artificial leaflet is made of commercially available porcine aortic valve, bovine pericardial valve, or porcine pericardial valve, or is made of a biocompatible polymer material, and is used to replace the physiological function of the original leaflet 500; preferably, the artificial leaflet is sewn to the inside of the valve stent 100.

[0081] In a preferred embodiment, the valve stent 100 is made of a biocompatible metal and has both collapsed and expanded forms. It can be delivered into the human body in a collapsed form and can be radially expanded by balloon inflation, mechanical dilator or its own shape memory properties. After being implanted in the heart and expanded, it takes the form of a roughly mesh-like tube, with the central part passing through a defined space for blood flow. The valve stent 100 can be anchored at the original valve annulus and accommodate the artificial valve leaflet.

[0082] Optionally, when the valve stent 100 is configured as a self-expanding stent, the valve stent 100 is made of a shape memory alloy, such as a nickel-titanium alloy or a copper-aluminum-nickel alloy; alternatively, when the valve stent 100 is configured as a balloon-expandable or mechanically expandable stent, the valve stent 100 is made of materials such as stainless steel or cobalt-based alloys.

[0083] In a preferred embodiment, the valve stent 100 is a self-expanding stent. The shape memory alloy material is processed by methods including but not limited to weaving, laser cutting, welding, riveting, and threading to form a multi-row interconnected polygonal grid structure. Adjacent grid structures are connected by elastic wave rods or nodes. The grid structure can be set as a rhomboid grid or a hexagonal grid. Preferably, the upper and lower diagonals of the grid structure are both V-shaped.

[0084] like Figure 1 In a preferred embodiment, the main body 110 of the valve stent 100 has a cylindrical or similar cylindrical structure, which can be positioned in the transition area connecting the original leaflet 500 and the chordae tendineae 600 of the mitral valve, and cooperate with the valve anchoring device 200.

[0085] Preferably, the cross-section of the main body 110 is circular, elliptical, D-shaped, or other shapes that are compatible with the mitral valve annulus.

[0086] More preferably, the inflow end of the valve stent 100 also has a skirt portion 140, which can be positioned at the annulus of the mitral valve. The skirt portion 140 is preferably configured as a flange-shaped structure. The skirt portion 140 includes a skeleton portion, which can optionally be made of cut metal tubes or woven metal wires. A sealing membrane is wrapped around the outside of the skeleton portion to prevent paravalvular leakage. Both the main body portion 110 and the skirt portion 140 are capable of radial expansion and compression, ensuring that they are compressed during delivery in the blood vessel and then open by self-expansion upon reaching the mitral valve.

[0087] refer to Figure 2 In a preferred embodiment, the valve anchoring device 200 includes a plurality of closed annular members 210', adjacent annular members 210' are elastically connected, and adjacent annular members 210' are arranged axially parallel to each other to form a fixing part. Preferably, the plurality of annular members 210' do not undergo radial deformation, and are used to support the main body 110 of the valve stent 100, and are matched and anchored to it; while the elastic connectors 220 between adjacent annular members 210' can provide the axial deformation capability of the valve anchoring device 200 to adapt to the morphological changes of myocardial tissue throughout the cardiac cycle.

[0088] Preferably, the annular member 210 is made of shape memory metal, preferably a nickel-titanium alloy, and the elastic connector 220 is also made of shape memory metal and is fixed to the annular member 210' by welding or pressing. Preferably, multiple elastic connectors 220 are symmetrically distributed along the circumference of the annular member 210', and each elastic connector 220 is parallel to the axial direction of the valve anchoring device 200.

[0089] Preferably, the annular component 210' is arranged in a straight line in the conveying device during transport. The two ends of the annular component 210' are provided with snap-fit ​​structures, which can be set as pins and grooves, such as the connection structure in Highlife. After reaching the left ventricle 400 and releasing the annular component 210', its shape returns from a straight line to an annular shape, and the ends are connected. The snap-fit ​​structures at both ends complete a stable connection, realizing the capture of the original leaflet 500 by the valve anchoring device 200.

[0090] Preferably, the valve anchoring device 200 includes at least two annular members 210', and the distance between adjacent annular members 210' is 1.0-5.0 mm; preferably, the axial length of the fixing part of the valve anchoring device 200 is adapted to the length of the main body 110 of the valve stent 100; preferably, the inner diameter of the valve anchoring device 200 is adapted to the outer diameter of the main body 110 of the valve stent 100.

[0091] Furthermore, the shape and size of the atrium / valve / ventricle may vary for different patients. Those skilled in the art will understand that the specific size of the valve anchoring device 200 and the number of the annular members 210' provided can be adaptively changed according to the patient's condition.

[0092] like Figure 3 In another preferred embodiment, the valve anchoring device 200 is configured as a generally spiral structure. In this case, the valve anchoring device 200 can be considered as being composed of multiple open-loop annular members 210 connected end to end, with each spiral being an annular member 210. On the one hand, the spiral structure can provide both axial and radial deformation capabilities to adapt to the morphological changes of myocardial tissue throughout the cardiac cycle, and is also more convenient during surgical placement. On the other hand, the structure can provide radially inward contraction force to support the main body 110 of the valve stent 100, matching and anchoring it to it.

[0093] In a preferred embodiment, the valve anchoring device 200 is formed by a pre-formed shape memory metal spiral, preferably a nickel-titanium alloy, which is capable of elastic deformation at least in the radial and axial directions to adapt to changes in the shape of the myocardial tissue; when delivered, the valve anchoring device 200 can be delivered in a straight line within the body and can be released within the left ventricle 400 and then wrap around the chordae tendineae 600.

[0094] Preferably, the valve anchoring device 200 includes at least two annular members 210, with a distance of 1.0-5.0 mm between adjacent annular members 210; preferably, the valve anchoring device 200 includes at least a fixing portion, the axial length of which is adapted to the length of the main body 110 of the valve stent 100; preferably, the inner diameter of the fixing portion is adapted to the outer diameter of the main body 110 of the valve stent 100. In some optional embodiments, the valve anchoring device 200 further includes an atrial fixing portion and / or a ventricular fixing portion, the distal ends of which extend toward the atrium or ventricle, respectively, for better positioning of the valve anchoring device 200 at the patient's heart valve.

[0095] Furthermore, the shape and size of the atrium / valve / ventricle may vary for different patients. Those skilled in the art will understand that the specific size of the valve anchoring device 200 and the number of the annular members 210 provided can be adapted to the patient's condition.

[0096] In this embodiment, a spiral-shaped annular member 210 is preferably used as an example, but it is understood that the same configuration in this embodiment can also be applied to a closed-loop annular member 210.

[0097] refer to Figure 4 , Figure 5 Preferably, a portion of the valve stent 100 mates with the annular member 210; the mating area between the valve stent 100 and the annular member 210 includes a first mating state and a second mating state, which are circumferentially spaced apart. Preferably, the first mating state is configured such that the valve stent 100 and the annular member 210 abut against each other, exhibiting an interference fit or a transition fit; preferably, the second mating state is configured such that there is a gap between the valve stent 100 and the annular member 210, exhibiting a gap fit, the gap between the valve stent 100 and the annular member 210 being used to accommodate the chordae tendineae 600 or the original leaflet 500.

[0098] Preferably, the gap formed by the second mating state is used to accommodate the chordae tendineae 600. Taking the mitral valve as an example, the chordae tendineae 600 in the human mitral valve are mostly distributed at both ends of the aortic leaflet and the parietal leaflet (at A1P1 and A3P3). In a preferred embodiment, after the artificial heart valve and the valve anchoring device 200 are implanted in the patient's body, by adjusting their angles and positions, the position of the second mating state coincides with the position of the chordae tendineae 600, so that the chordae tendineae 600 can pass through the gap between the valve stent 100 and the annular member 210, avoiding the artificial heart valve and the valve anchoring device 200 from squeezing and rubbing the chordae tendineae 600.

[0099] Preferably, a protrusion 120 is provided in a portion of the main body 110 of the valve stent 100. The protrusion 120 protrudes in the radial direction of the main body 110 and is used to abut against the annular member 210 to form a first mating state. The area without the protrusion 120 can be clearance-fitted with the annular member 210 to form a second mating state.

[0100] Preferably, the protrusion 120 is arched and disposed on the outer periphery of the main body 110. The inner surface of the protrusion 120 is adapted to the outer periphery contour of the main body 110 to ensure that the protrusion 120 can change synchronously with the expansion and contraction of the main body 110 of the valve stent 100. This facilitates the control of the volume of the artificial heart valve in the delivery system, so that it will not cause difficulties in delivery due to excessive volume or irregular contour.

[0101] Preferably, at least two protrusions 120 are provided circumferentially on the main body 110, and the arc length of each protrusion 120 is not greater than half the circumference of the main body 110. This arrangement ensures that there are gaps between the protrusions 120, which facilitate the passage of the chordae tendineae 600 or the original leaflet 500 through these gaps after engagement with the valve anchoring device 200. Figure 5 More preferably, after engaging with the valve anchoring device 200, the cross-sectional dimension of the gap between adjacent protrusions 120 in the circumferential direction needs to be greater than the cross-sectional dimension of the chordae tendineae 600 or the original leaflet 500 at this location.

[0102] In a preferred embodiment, the length of the protrusion 120 in the vertical direction is not less than the width of the fixing part in the vertical direction. That is, when there are multiple annular members in the fixing part, the length of the protrusion 120 in the vertical direction is not less than the width of the multiple annular members in the vertical direction, so that the protrusion 120 can have a first engagement state and a second engagement state with each annular member 210 of the fixing part, ensuring that the tendineae 600 or the original leaflet 500 can pass through the gap between the protrusion 120 and the fixing part. More preferably, the second engagement state formed by the protrusion 123 and the annular member 210 can at least ensure that the tendineae 600 can pass through.

[0103] In another preferred embodiment, the length of the protrusion 120 in the vertical direction is not less than the width of the annular member 210 in the vertical direction. That is, when there are multiple annular members in the fixing part, each annular member 210 is provided with a protrusion 120 at the point where it abuts against the main body 110. Preferably, a number of protrusions 120 are arranged circumferentially along the valve stent 100, and then each circumferentially arranged protrusion 120 is axially distributed with multiple protrusions 120 along the same axis. The number of axial protrusions 120 is the same as the number of annular members 210 on the fixing part, so as to ensure that the number and position of the protrusions 120 correspond one-to-one with the annular members 210.

[0104] In a preferred embodiment, each annular member 210 is provided with a protrusion 120 at the point where it abuts against the main body 110, and the plurality of axially arranged protrusions 120 are arranged on the same axis. Furthermore, the thickness of the plurality of axially arranged protrusions 120 gradually increases from the valve annulus towards the ventricle, that is, in the vertical direction, the thickness of the protrusions 120 gradually increases from top to bottom, to ensure that the valve stent 100 can have a gap with the annular member 210 at least at the chordae tendineae 600 to accommodate the chordae tendineae 600. In one preferred embodiment, adjacent protrusions 120 are arranged at equal intervals; in another preferred embodiment, adjacent protrusions 120 are arranged at unequal intervals; more preferably, since the anterior leaflet of the mitral valve primary leaflet 500 is large and the posterior leaflet is small, the size and / or volume of the chordae tendineae 600 connected to the anterior and posterior leaflets are different. When two protrusions 120 are provided, the gap formed by the two protrusions 120 at one end is slightly larger to accommodate the larger size / volume of the chordae tendineae 600; the gap formed by the two protrusions 120 at the other end is slightly smaller to accommodate the smaller size / volume of the chordae tendineae 600.

[0105] Preferably, the multiple protrusions 120 may have the same or different arc lengths, and the gap size formed between adjacent protrusions 120 can be changed by the different arc lengths and positions of the multiple protrusions 120.

[0106] Preferably, the protrusions 120 have the same or different protrusion thicknesses in the circumferential direction. Taking two protrusions 120 as an example, when the sizes of the chordae tendineae 600 connected to the anterior and posterior leaflets of the mitral valve primary leaflet 500 differ significantly, the protrusion thickness of the protrusion 120 is preferably thicker at one end and slightly thinner at the other. The other protrusion 120 is also configured to be thicker at one end and slightly thinner at the other, with the thicker end facing each other and the thinner end facing each other. After the thicker protrusion 120 abuts against the annular member 210, it can form a larger gap with the adjacent protrusion 120 to accommodate the larger chordae tendineae 600. After the thinner protrusion 120 abuts against the annular member 210, it can form a smaller gap with the adjacent protrusion 120 to accommodate the smaller chordae tendineae 600.

[0107] Optionally, the protrusion 120 is made of a rigid polymer material or a metal material and is fixed to the main body 110 by means of bonding, welding, hinge, fusion, riveting or integral molding.

[0108] Preferably, a first connector is provided on the valve stent 100. The first connector tends to extend toward the fixing part, and it can pierce or not pierce the original leaflet 500 and cooperate with the annular member 210.

[0109] In one preferred embodiment, the first connector is disposed on the mesh structure of the main body 110 of the valve stent 100 where the protrusion 120 is not provided; in another preferred embodiment, the first connector is disposed in the area of ​​the protrusion 120 of the valve stent 100, the first connector can be fixed to the mesh structure and penetrate the protrusion 120, or the first connector is disposed on the outer surface of the protrusion 120.

[0110] In a preferred embodiment, the first connector is configured as a plurality of anchoring arms 130. Preferably, the plurality of anchoring arms 130 can be attached to the outer surface of the valve stent 100 or the protrusion 120 in the compressed state, and extend radially outward toward the valve stent 100 in the released state, and at least penetrate into the original leaflet 500. More preferably, the anchoring arms 130 extend out of the original leaflet 500 and stably abut against the valve anchoring device 200.

[0111] Preferably, the anchoring arm 130 may be made of shape memory alloy, polymer, fiber or other polymeric material, and is fixed to the outer surface of the valve stent 100 or the protrusion 120 by welding, pressing or riveting.

[0112] Optionally, the anchoring arm 130 extends radially outward toward the outflow end; preferably, the anchoring arm 130 extends radially outward and toward the inflow end, corresponding to the mitral valve, that is, extending radially obliquely upward, forming a barb-like structure. When the anchoring arm 130 passes through the original leaflet 500, it can abut against the lower side of the annular member, so that the valve stent 100 and the valve anchoring device 200 are tightly connected and a stable anchoring force is generated, preventing the valve stent 100 from displacing during cardiac activity.

[0113] Optionally, the shape, size, tilt angle, etc. of the anchor arms 130 set at different positions can be the same or different from each other; optionally, the anchor arms 130 can be set on one or more rows of grid structure and can be circumferentially symmetrically distributed or circumferentially staggered.

[0114] In a preferred embodiment, the first connector is configured as a plurality of magnetic components; preferably, the magnetic components are disposed on the outer surface of the valve stent 100 or the outer surface of the protrusion 120 or the interior of the protrusion 120 close to the outer surface.

[0115] Preferably, the annular member 210 is made of a ferromagnetic metal material, so that even if only a magnetic member is provided on the valve stent 100, magnetic attraction between the annular member 210 and the valve stent 100 can be achieved.

[0116] Preferably, the magnetic component can be made of neodymium iron boron alloy, which is characterized by small size, light weight and strong magnetism, in order to provide a greater magnetic attraction.

[0117] In a preferred embodiment, the fixing part of the valve anchoring device 200 is further provided with a second connector, which has a tendency to extend toward the main body 110, and can pierce or not pierce the original leaflet 500, and cooperate with the main body 110.

[0118] Preferably, the second connector is also configured as several magnetic components, which are disposed on the outer surface of the fixing part or close to the inner surface of the fixing part; more preferably, when both the annular component 210 and the valve stent 100 are provided with magnetic components, the magnetic components can be symmetrically distributed or staggered along the circumference, but it is necessary to ensure that the positions match each other so as to ensure that the annular component 210 and the valve stent 100 can attract each other.

[0119] Preferably, when magnetic components are provided only on the main body 110 of the valve stent 100, the annular component 210 shall be provided with a ferromagnetic material at least in the section corresponding to the first connector; when multiple magnetic components are provided only on the annular component 210, the main body 110 of the valve stent 100 shall be provided with a ferromagnetic material at least in the section corresponding to the second connector.

[0120] In this embodiment, the method of using the above-mentioned transcatheter heart valve replacement system is as follows:

[0121] During delivery, the valve anchoring device 200 is linearly positioned within the delivery device. It travels through the delivery device via a blood vessel or through the apex of the heart to reach the left ventricle 400, and is then delivered between the mitral valve chordae tendineae 600 and the wall of the left ventricle 400. The valve anchoring device 200 passes through the gap between the chordae tendineae 600 and the wall of the left ventricle 400, is delivered along the wall of the left ventricle 400, and ultimately wraps around the chordae tendineae 600. Figure 12 On the one hand, it enables the capture of the mitral valve leaflets, and on the other hand, it provides anchor points for the subsequent implantation of artificial heart valves.

[0122] The artificial heart valve is compressed via a delivery device and introduced through the femoral vein. After passing through the interatrial septum to reach the mitral valve, it is released. The protrusion 120 of the valve stent 100 abuts against the radially inner side of the fixing part of the valve anchoring device 200, forming a first engagement state. The area of ​​the main body 110 without the protrusion 120 fits with the valve anchoring device 200 with a gap, forming a second engagement state. In this state, the gap between the main body 110 and the valve anchoring device 200 can accommodate the native leaflet 500 or the chordae tendineae 600. The first connector on the main body 110 expands radially outward and abuts against the lower side of the annular member, achieving further anchoring of the artificial heart valve through friction. The skirt 140 is correspondingly positioned on the left atrium 300 side of the mitral valve to prevent paravalvular leakage and reduce surgical risks. Figure 13 .

[0123] Because the artificial heart valve has at least two protrusions 120, there will be at least two gaps between the artificial heart valve and the valve anchor. Before the artificial heart valve is fully released, its direction is changed by rotation so that the gap appears at the patient's chordae tendineae 600 (such as A1P1 and A3P3 of the mitral valve). Ultimately, the chordae tendineae 600 can pass through the gap, avoiding the artificial heart valve and the valve anchor 200 from squeezing or rubbing the chordae tendineae 600, which would cause the chordae tendineae 600 to tear.

[0124] Example 2

[0125] refer to Figures 9-13 Taking mitral valve implantation as an example, this embodiment provides a transcatheter heart valve replacement system, which also includes an artificial heart valve and a valve anchoring device 200. Preferably, the protrusion 120 is no longer provided on the outer side of the artificial heart valve. Figure 6 Other structures are the same as in Embodiment 1 above; preferably, the valve anchoring device 200 in this embodiment can be configured as several closed-loop structures or spiral structures; the features already described in Embodiment 1 above are naturally inherited in this embodiment and will not be repeated.

[0126] like Figure 7 , Figure 8 Preferably, the valve anchoring device 200 includes several annular members 210, each annular member 210 having a recess 230 on its inner circumference. The recess 230 can be clearance-fitted with the main body 110 of the valve stent 100 to form a second fit, the gap between which can accommodate the original leaflet 500 or chordae tendineae 600; the area without the recess 230 can abut against the main body 110 to form a first fit. (Refer to...) Figures 9-11 .

[0127] In a preferred embodiment, the recess 230 is configured as a tapering section on the annular member 210; the tapering section is waist-shaped; the gap between the tapering section and the main body 110 is used to accommodate the chordae tendineae 600. Specifically, the tapering section is waist-shaped at least on the side facing the main body 110. Preferably, after the valve anchoring device 200 is engaged with the artificial heart valve, the cross-sectional dimension of the gap between the recess 230 and the artificial heart valve needs to be larger than the cross-sectional dimension of the chordae tendineae 600 at this location.

[0128] In a preferred embodiment, each annular member 210 is provided with at least two recesses 230 spaced apart in the circumferential direction, and adjacent recesses 230 are spaced at equal or unequal intervals. Specifically, each recess 230 corresponds to at least one or more tendons 600, and the position of the recess 230 on the annular member 210 matches the position of the tendons 600.

[0129] Because the anterior leaflet of the mitral valve primary leaflet 500 is large and the posterior leaflet is small, the size and / or volume of the chordae tendineae 600 connecting the anterior and posterior leaflets differ. Therefore, optionally, each recess 230 may have the same or different arc lengths; optionally, each recess 230 may have the same or different variable diameter dimensions to accommodate chordae tendineae 600 of different shapes / sizes / volumes.

[0130] Preferably, the fixing part has at least two annular members 210, and the recesses 230 on adjacent annular members 210 are positioned corresponding to each other. That is, multiple recesses 230 are arranged circumferentially along one annular member 210, and then the recesses 230 on adjacent annular members 210 are arranged axially along the same axis, with the positions of the axial recesses 230 corresponding one-to-one, so as to ensure that the tendon chord 600 can pass through the gap formed by the recesses 230 on several annular members 210, and avoid the tendon chord 600 being unable to pass through due to the staggered positions of the recesses 230 on adjacent annular members 210.

[0131] In this embodiment, the method of using the above-mentioned transcatheter heart valve replacement system is the same as in Embodiment 1 above. The difference is that before the valve anchoring device 200 is fully released, its direction is adjusted by rotation so that the recess 230 corresponds to the patient's chordae tendineae 600 (such as A1P1 and A3P3 of the mitral valve). Ultimately, the chordae tendineae 600 can pass through the gap, avoiding the artificial heart valve and the valve anchoring device 200 from squeezing or rubbing the chordae tendineae 600, which would cause the chordae tendineae 600 to tear.

[0132] Example 3

[0133] Taking mitral valve implantation as an example, this embodiment provides a transcatheter heart valve replacement system, which also includes an artificial heart valve and a valve anchoring device 200. The features described in Embodiment 1 above are naturally inherited in this embodiment.

[0134] like Figure 14 Preferably, the valve stent 100 has a protrusion 120 on its outer side and a recess 230 on its annular member 210, with the protrusion 120 and the recess 230 staggered in the circumferential direction. More preferably, after the valve anchoring device 200 is engaged with the artificial heart valve, the annular member 210 corresponding to the area of ​​the main body 110 where the protrusion 120 is not provided has a recess 230, so that a larger gap can be made between adjacent protrusions 120, further increasing the space for accommodating the chordae tendineae 600.

[0135] Example 4

[0136] In this embodiment, a transcatheter heart valve replacement system is provided, which includes an artificial heart valve and a valve anchoring device 200.

[0137] refer to Figure 15 , Figure 16 Preferably, in the cross-sections of the main body 110 and the fixing part, one is circular and the other is non-circular; the two are tangent in some sections, and the tangent area is the first mating state; they are separated in some sections, and the separated area is the second mating state, and the separated area is used to accommodate the tendineae 600 or the original leaflet 500.

[0138] Optionally, the cross-section of the main body 110 is circular, and the cross-section of the fixing part is elliptical, triangular, D-shaped, or similar, ensuring that the cross-sections of the main body 110 and the fixing part have at least two points of contact. Those skilled in the art should understand that if the cross-sections of the main body 110 and the fixing part have only one point of contact, it indicates that their dimensions do not match and they cannot be anchored to each other at the original valve ring.

[0139] In a preferred embodiment, the cross-section of the main body 110 is circular, and the cross-section of the fixing part is elliptical. The two have two tangent points, and the other areas are separate. The tangent points are the first fitting state, and the separate areas are the second fitting state. Preferably, the minor axis of the ellipse of the fixing part's cross-section should not be greater than the diameter of the cross-section of the main body 110, so as to ensure that the fixing part and the main body 110 can be overfitted or interference-fitted at the tangent points, so that the two can fit stably. Preferably, the major axis of the ellipse of the fixing part's cross-section should be greater than the diameter of the cross-section of the main body 110, so as to ensure that the tendon 600 can pass through the gap between the fixing part and the main body 110.

[0140] In another preferred embodiment, the main body 110 has a circular cross-section, and the fixing part has a triangular annular cross-section. The two have three tangent points, and the other areas are separate. The tangent points are in a first mating state, and the separate areas are in a second mating state. The gap between adjacent tangent points corresponds to the separate areas and also corresponds to the three protruding corners of the triangular annular ring. This space is used to accommodate the tendineae 600.

[0141] In this embodiment, the method of using the above-mentioned transcatheter heart valve replacement system is the same as in Embodiment 1 above. The difference is that before the valve anchoring device 200 is fully released, its direction is adjusted by rotation so that its outward protruding area corresponds to the patient's chordae tendineae 600 (such as A1P1 and A3P3 of the mitral valve). Ultimately, the chordae tendineae 600 can pass through the gap between the valve anchoring device 200 and the artificial heart valve, avoiding the artificial heart valve and the valve anchoring device 200 from squeezing or rubbing the chordae tendineae 600, which would cause the chordae tendineae 600 to tear.

[0142] Example 5

[0143] In this embodiment, a transcatheter heart valve replacement system is provided, which includes an artificial heart valve and a valve anchoring device 200.

[0144] refer to Figure 17 , Figure 18 Preferably, in the cross-sections of the main body 110 and the fixing part, one is circular and the other is non-circular; the two are tangent in some sections, and the tangent area is the first mating state; they are separated in some sections, and the separated area is the second mating state, and the separated area is used to accommodate the tendineae 600 or the original leaflet 500.

[0145] Preferably, the cross-section of the fixing part is circular, and the cross-section of the main body 110 is elliptical or D-shaped, ensuring that the cross-sections of the main body 110 and the fixing part have at least two tangent points, with the gap between the tangent points used to accommodate the tendineae 600. Those skilled in the art will understand that if the cross-sections of the main body 110 and the fixing part have only one tangent point, it indicates that their dimensions do not match and they cannot be anchored to each other at the original valve annulus.

[0146] Unlike Embodiment 4 described above, the cross-section of the main body 110 is not set to another polygon, as this could affect blood flow. The reason for setting its cross-section to a D-shape is that the cross-section of the native mitral valve is mostly D-shaped, so this setting can better fit the patient's native valve.

[0147] Preferably, the major axis of the elliptical cross-section of the main body 110 should not be less than the diameter of the cross-section of the fixing part, so as to ensure that the fixing part and the main body 110 can be overfitted or interference-fitted at the tangent point, so that the two can be stably fitted; preferably, the minor axis of the elliptical cross-section of the main body 110 should be less than the diameter of the cross-section of the fixing part, so as to ensure that the tendon 600 can pass through the gap between the fixing part and the main body 110.

[0148] In this embodiment, the method of using the above-mentioned transcatheter heart valve replacement system is the same as in Embodiment 1 above. The difference is that, before the artificial heart valve is fully released, its direction is adjusted by rotation so that the chordae tendineae 600 can pass through the gap between the valve anchoring device 200 and the artificial heart valve, thereby avoiding the artificial heart valve and the valve anchoring device 200 from squeezing or rubbing the chordae tendineae 600 and causing tearing of the chordae tendineae 600.

[0149] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of the present invention.

Claims

1. A transcatheter heart valve replacement system, characterized in that, Including artificial heart valves and valve anchoring devices; The valve anchoring device includes a fixing part, the fixing part including at least one annular member; the valve anchoring device can be positioned outside the native valve chordae tendineae and adapt to changes in the native valve annulus morphology; The artificial heart valve includes a valve stent, at least a portion of which defines a flow channel for blood flow; the artificial heart valve is capable of being positioned medial to the native valve and replacing the physiological function of the native valve. At least a portion of the valve stent mates with the annular member; the mate between the valve stent and the annular member includes a first mating state and a second mating state, the first mating state and the second mating state being circumferentially spaced apart and coexisting simultaneously; The first mating state is configured such that the valve stent and the annular member abut against each other, and the two are in an interference fit or an overfit; The second mating state is configured such that there is a gap between the valve stent and the annular member, and the two are in a gap fit; the gap between them is used to accommodate the chordae tendineae or the original leaflets.

2. The transcatheter heart valve replacement system according to claim 1, characterized in that, The valve stent includes a main body portion, at least a portion of which cooperates with the annular member. The outer periphery of the main body is provided with a protrusion, and / or the inner periphery of the annular member is provided with a recess; The protrusion protrudes along the radial direction of the main body and is used to form the first mating state with the annular member; the area without the protrusion can form the second mating state with the annular member. The recessed portion is recessed in the radial direction of the annular member to form a second mating state with the main body portion, and the area without the recessed portion can form a first mating state with the main body portion.

3. The transcatheter heart valve replacement system according to claim 2, characterized in that, The outer periphery of the main body is provided with a protrusion, and the inner periphery of the annular member is provided with a recess; the protrusion and the recess are staggered in the circumferential direction.

4. The transcatheter heart valve replacement system according to claim 2, characterized in that, The protrusion is arched and disposed on the outer periphery of the main body, and the inner surface of the protrusion is adapted to the outer periphery contour of the main body; The arc length of the protrusion is not greater than half the circumference of the main body; the length of the protrusion in the vertical direction is not less than the width of the fixing part in the vertical direction.

5. The transcatheter heart valve replacement system according to claim 4, characterized in that, The main body is provided with at least two protrusions, and adjacent protrusions are arranged at equal or unequal intervals; the space between adjacent protrusions is used to accommodate chordae tendineae or native leaflets.

6. The transcatheter heart valve replacement system according to claim 4, characterized in that, The main body is provided with at least two protrusions; the protrusions are provided with equal or unequal wall thickness in the circumferential direction, and / or, the protrusions are provided with equal or unequal wall thickness in the axial direction.

7. The transcatheter heart valve replacement system according to any one of claims 2-6, characterized in that, The protrusion is made of rigid polymer material or metal material and is fixed to the main body by means of bonding, welding, hinge, fusion, riveting or integral molding.

8. The transcatheter heart valve replacement system according to claim 2, characterized in that, The recessed portion is configured as a variable-diameter section on the annular member, the variable-diameter section being waist-shaped; the gap between the variable-diameter section and the main body is used to accommodate chordae tendineae or native leaflets.

9. The transcatheter heart valve replacement system according to claim 8, characterized in that, The annular component has at least two recesses, and adjacent recesses are spaced equidistantly or unequally.

10. The transcatheter heart valve replacement system according to claim 8 or 9, characterized in that, The fixing part is provided with at least two of the annular components, and the recesses on adjacent annular components are positioned corresponding to each other.

11. The transcatheter heart valve replacement system according to claim 1, characterized in that, The valve stent includes a main body; In the cross-section of the main body and the fixed part, one is circular and the other is non-circular; the two are tangent in some sections and separate in some sections, and the separated area is used to accommodate the chordae tendineae or the original leaflets.

12. The transcatheter heart valve replacement system according to claim 11, characterized in that, The main body has a circular cross-section, and the fixing part has an elliptical cross-section, with two tangent points. Alternatively, the main body has a circular cross-section, and the fixing part has a triangular annular cross-section, with three tangent points; The gap between adjacent tangent points of the cross-sections of the main body and the fixing part is used to accommodate chordae tendineae or native leaflets.

13. The transcatheter heart valve replacement system according to claim 11, characterized in that, The main body has an elliptical or D-shaped cross-section, and the fixing part has a circular cross-section, with two tangent points; the gap between the tangent points is used to accommodate the tendineae or the original leaflets.

14. The transcatheter heart valve replacement system according to claim 2 or 11, characterized in that, The valve stent is provided with a first connector, which is disposed on the outer surface of the main body and has a tendency to extend toward the fixing part; the first connector may or may not pierce the original leaflet and cooperates with the annular member. And / or, the fixing part is provided with a second connector, the second connector having a tendency to extend toward the main body; the second connector may or may not pierce the original leaflet and cooperate with the main body.

15. The transcatheter heart valve replacement system according to claim 14, characterized in that, The first connector includes several anchor arms, which are disposed on the outside of the protrusion or the main body and extend radially outward; The anchoring arm is bent in a direction away from the blood flow; or, the anchoring arm is bent in a direction in accordance with the blood flow.

16. The transcatheter heart valve replacement system according to claim 14, characterized in that, The first connector includes several magnetic components; The magnetic component is disposed on the outer surface of the valve stent, or the magnetic component is disposed on the outer peripheral surface of the protrusion, or the magnetic component is disposed inside the protrusion close to the outer peripheral surface.

17. The transcatheter heart valve replacement system according to claim 14, characterized in that, The second connector includes several magnetic components, which are disposed on the outer surface of the fixing part or inside the part close to the outer surface.

18. The transcatheter heart valve replacement system according to claim 1, characterized in that, The valve stent includes a main body and a skirt portion; The skirt portion has a flange-shaped structure, and the small-diameter end of the skirt portion is connected to the main body portion; The main body includes several interconnected polygonal mesh structures.

19. The transcatheter heart valve replacement system according to claim 1, characterized in that, The fixing part includes a plurality of ring-shaped components, with adjacent ring-shaped components connected end to end in a spiral structure.

20. The transcatheter heart valve replacement system according to claim 1, characterized in that, The fixing part includes a plurality of ring components, each ring component being a closed ring, the plurality of ring components being arranged axially parallel, and adjacent ring components being elastically connected.

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