CN115969578A - A transcatheter heart valve replacement system - Google Patents

Abstract

The invention relates to a transcatheter heart valve replacement system, which is composed of an artificial heart valve and a valve anchoring device, wherein the valve anchoring device can surround the outside of the valve chordae, capture the original valve leaflets, and serve as the implantation of the subsequent artificial heart valve. The insertion provides an anchor point; the artificial heart valve can be implanted in the heart and replace the physiological function of the original valve. The valve anchoring device and the artificial heart valve can cooperate and position each other. In order to prevent the chordal tendon from being broken due to the tight cooperation between the two and the continuous extrusion and friction, there are two cooperation states between the two: the first cooperation state, which can Let the artificial heart valve and the valve anchoring device touch each other to ensure the stability of the structure and position when the two cooperate with each other; in the second mating state, there is a gap between the artificial heart valve and the valve anchoring device at this time, so that the original leaflets Or the chord tendineum can pass through it, so as to minimize the contact area between the valve replacement system and the chord tendon, and avoid squeezing the chord tendon.

Description

A transcatheter heart valve replacement system

technical field

The invention relates to the field of medical devices for cardiac intervention, in particular to a transcatheter heart valve replacement system.

Background technique

In recent years, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in the elderly population >75 years old is as high as 13.3%. Surgical treatment is still the first choice for patients with severe valvular disease, but for patients with advanced age, multiple organ diseases, history of open chest surgery, and poor cardiac function, the EuroSCORE and/or STS scores are high, and the surgical mortality rate is high , and even some patients lost the chance of surgery. In recent years, transcatheter valve implantation/repair has gradually matured and been widely used.

Compared with traditional valve products, a current transcatheter heart valve replacement system consists of two parts: an artificial valve and an anchoring device. The working principle of the system is as follows: the anchoring device (fishing ring) is implanted under the valve annulus of the patient through a catheter, the fishing ring passes through the gap between the chordae tendon and the ventricular wall under the valve annulus, and is fixed by winding the chordae tendon At the valve annulus of the patient, a valve anchoring device is formed; the prosthetic valve is implanted into the patient's heart through a catheter, released and deployed in the anchoring device (fishing ring). The prosthetic valve is secured within the anchoring device, which eventually replaces the patient's valve.

After the above-mentioned transcatheter heart valve replacement system is implanted in the patient's body, since the artificial valve and the anchoring device are tightly fitted in the circumferential direction, the patient's chordae and leaflets are sandwiched between the artificial valve and the anchoring device. As the patient's heart beats, the two constantly squeeze and rub against the chordae, which may rupture the chordae and dislodge the anchoring device and artificial valve.

Based on the above deficiencies, how to redesign the position or structural relationship between the artificial valve and the anchoring device, under the premise of ensuring the stable connection between the two and the chord tendineum, and avoiding the extrusion or friction of the two on the chord tendon has become an urgent problem to be solved. technical problems.

Contents of the invention

The invention discloses a transcatheter heart valve replacement system, aiming to solve the technical problems existing in the prior art.

The present invention adopts following technical scheme:

Provide a transcatheter heart valve replacement system, including an artificial heart valve and a valve anchoring device;

The valve anchoring device includes a fixing part, and the fixing part includes at least one annular member; the valve anchoring device can be positioned outside the native valve chordae and conforms to changes in the shape of the native valve ring;

The artificial heart valve includes a valve stent, and at least a part of the valve stent defines a flow channel for blood circulation; the artificial heart valve can be positioned inside the original valve and replace the physiological function of the original valve;

At least a partial area of the valve support cooperates with the annular member; the joint between the valve support and the annular member includes a first mating state and a second mating state, and the first mating state and the second mating state are circumferentially spaced apart;

The first fit state is configured as follows: the valve support and the annular member abut against each other, and the two are interference fit or over fit;

The second fit state is configured as follows: there is a gap between the valve support and the annular member, and the two are in a gap fit; the gap between the two is used to accommodate the chordae or the native valve leaflet.

As a preferred technical solution, the valve support includes a main body, and at least a partial area of the main body cooperates with the annular member;

The outer periphery of the main body is provided with a convex part, and/or, the inner periphery of the ring member is provided with a concave part;

The protrusion protrudes along the radial direction of the main body, and is used to form a first mating state with the ring member, and the area where the protrusion is not provided can form a second mating state with the ring member;

The recessed portion is recessed along the radial direction of the ring member for forming a second mating state with the main body, and an area not provided with the recessed portion can form a first mating state with the main body.

As a preferred technical solution, a protrusion is provided on the outer periphery of the main body, and a recess is provided on the inner periphery of the ring member; the protrusions and recesses are alternately arranged in the circumferential direction.

As a preferred technical solution, the raised portion is arched and arranged on the outer periphery of the main body, and the inner surface of the raised portion matches the outer peripheral contour of the main body;

The arc length of the raised portion is not greater than half of the circumference of the main body; the length of the raised portion in the vertical direction is not less than the width of the fixed portion in the vertical direction.

As a preferred technical solution, the main body part is provided with at least two protrusions, and the adjacent protrusions are equidistantly or unequally spaced; the space between the adjacent protrusions is used to accommodate the chordae tendineae or the original leaflets.

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 have equal or unequal wall thickness in the axial direction Wall thickness settings.

As a preferred technical solution, the protruding part is made of hard polymer material or metal material, and is affixed to the main body by bonding, welding, hinged, welded, hinged, riveted or integrally formed.

As a preferred technical solution, the concave portion is configured as a diameter-reducing section on the ring member, and the diameter-reducing section is waist-shaped; the gap between the diameter-reducing section and the main body is used to accommodate the chordae tendineae or the original leaflet.

As a preferred technical solution, the ring member is provided with at least two recessed portions, and adjacent recessed portions are equidistantly or unequally spaced.

As a preferred technical solution, the fixing part is provided with at least two ring members, and the positions of the recesses on adjacent ring members correspond to each other.

As a preferred technical solution, the valve support includes a main body;

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

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

Alternatively, the cross-section of the main body is circular, and the cross-section of the fixing portion is triangular, and the two have three points of contact;

The space between the adjacent tangent points of the cross-sections of the body portion and the fixation portion is used to accommodate the chordae or native valve leaflets.

As a preferred technical solution, the cross-section of the main body is oval or D-shaped, and the cross-section of the fixed part is circular, and the two have two tangent points; the space between the tangent points is used to accommodate the chordae tendineae or the original valve leaflets .

As a preferred technical solution, the valve support is provided with a first connecting piece, the first connecting piece is arranged on the outer surface of the raised portion or the outer surface of the main body, and the first connecting piece has a tendency to extend toward the fixed portion; the first connecting piece Puncture or not pierce the native valve leaflet and cooperate with the annular member;

And/or, the fixing part is provided with a second connecting part, and the second connecting part has a tendency to extend toward the main part; the second connecting part pierces or does not pierce the original leaflet, and cooperates with the main part.

As a preferred technical solution, the first connecting piece includes several anchoring arms, and the anchoring arms are arranged 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; alternatively, the anchoring arm is bent in a direction conforming to the blood flow.

As a preferred technical solution, the first connecting piece includes several magnetic components, and the magnetic components are arranged on the outer peripheral surface of the protruding portion or approach the interior of the outer peripheral surface.

As a preferred technical solution, the second connecting piece includes several magnetic components, and the magnetic components are arranged on the outer surface of the fixing part or the interior close to the outer surface.

As a preferred technical solution, the valve support includes a main body and a skirt;

The skirt is in the shape of a flange, and the small-diameter end of the skirt is connected to the main body; the main body includes several interconnected polygonal grid structures.

As a preferred technical solution, the fixing part includes a plurality of ring members, and adjacent ring members are connected end to end to form a helical structure.

As a preferred technical solution, the fixing part includes a plurality of ring members, each ring member is in a closed ring shape, the plurality of ring members are axially arranged in parallel, and adjacent ring members are elastically connected.

The technical scheme adopted in the present invention can achieve the following beneficial effects:

(1) The present invention provides a transcatheter heart valve replacement system, which consists of a prosthetic heart valve and a valve anchoring device, wherein the valve anchoring device can surround the outside of the valve chordae, and capture the original valve leaflets for subsequent artificial heart valves. The implantation of the heart valve provides an anchor point; the artificial heart valve can be implanted in the mitral valve and 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 prevent the artificial heart valve from undesired displacement due to tissue expansion/contraction during the cardiac cycle. In order to prevent the chordal tendon from being broken due to excessive tightness and continuous extrusion and friction, there are two cooperation states between the valve anchoring device and the artificial heart valve: the first cooperation state allows the artificial heart valve and the valve anchor The devices abut against each other, and the two are over-fit or interference-fit to ensure the stability of the structure and position when the valve anchoring device and the artificial heart valve cooperate with each other; the second cooperation state, at this time, there is a gap between the artificial heart valve and the valve anchoring device. A gap is present to allow the native valve leaflets or chordae to pass through to minimize the contact area between the valve replacement system and the chordae and avoid pinching the chordae and causing it to rupture.

(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 raised portion; the valve anchoring device includes a fixing portion, and the fixing portion has one or several ring members, There is a concave part on the ring member; the convex part and the concave part can be set at the same time, or only one of them can be provided, but when they are set at the same time, the convex part and the concave part are arranged alternately; wherein, the gap between the circumferentially adjacent convex parts It can be used to accommodate native valve leaflets or chordae, and the gap between the recess itself and the valve support can also be used to accommodate native valve leaflets or chordae.

(3) In some preferred embodiments of the present invention, in the cross-section of the main body part 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 in the partial area The segments are tangent to each other, and some segments are separated; the tangent point between the two represents the first cooperation state, which ensures the stability of the structure and position when the valve anchoring device and the artificial heart valve cooperate with each other; the distance between the two represents the first cooperation state. 2. In the coordinated state, avoid squeezing the chord and cause it to break.

(4) In some preferred embodiments of the present invention, a first connecting piece is arranged outside the valve support, and the first connecting piece can be an anchoring arm or a magnetic member; when the first connecting piece is an anchoring arm, the anchoring arm can be It passes through the original valve leaflet radially and abuts against the valve anchoring device, so that the two can be connected stably, and the artificial heart valve cannot be easily separated from the valve anchoring device, even if the heart occurs or suffers a large tremor, or the original valve relapses For organic lesions, the replacement system of the present application can still function normally; when the first connector is a magnetic member, it is preferable to use the same magnetic member as that set in the valve anchoring device, in order to provide magnetic connection and larger of friction.

(5) In some preferred embodiments of the present invention, a second connecting piece can be provided inside the valve anchoring device, and the second connecting piece can be an anchoring arm or a magnetic member; when the second connecting piece is an anchoring arm , the anchoring arm can pierce the original valve leaflet radially inward, or be further connected with the first connecting piece on the artificial heart valve; when the first connecting piece is a magnetic member, at least some sections of the artificial heart valve are also set It is a magnetic component or has ferromagnetism, and at this time, the valve anchoring device is magnetically connected with the artificial heart valve.

(6) In a preferred embodiment of the present invention, the inflow end of the artificial heart valve is provided with a skirt portion, the skirt portion is in the shape of a flange, and is provided with a hard skeleton, and a sealing film is sewn on its outside for Filling the gap between the artificial heart valve and the valve anchoring device can effectively prevent paravalvular leakage and reduce the risk of surgery.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings that need to be used in the description of the embodiments will be briefly introduced below, which constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions explain the present invention , does not constitute an improper limitation of the present invention. In the attached picture:

FIG. 1 is a schematic structural view of an artificial heart valve in a preferred embodiment disclosed in Example 1 of the present invention;

Fig. 2 is a schematic structural view of a valve anchoring device in a preferred embodiment disclosed in Example 1 of the present invention;

Fig. 3 is a schematic structural view of a valve anchoring device in another preferred embodiment disclosed in Example 1 of the present invention;

Fig. 4 is a diagram of the cooperation state of the artificial heart valve and the valve anchoring device in a preferred embodiment disclosed in Example 1 of the present invention;

Fig. 5 is a sectional view of Fig. 4;

Fig. 6 is a schematic structural view of an artificial heart valve in a preferred embodiment disclosed in Example 2 of the present invention;

Fig. 7 is a schematic structural view of a valve anchoring device in a preferred embodiment disclosed in Example 2 of the present invention;

Fig. 8 is a top view of a valve anchoring device in a preferred embodiment disclosed in Example 2 of the present invention;

Fig. 9 is a diagram of the cooperation state of the artificial heart valve and the valve anchoring device in a preferred embodiment disclosed in Example 2 of the present invention;

Figure 10 is a bottom view of Figure 9;

Figure 11 is a cross-sectional view of Figure 9;

Fig. 12 is a diagram of the use state of the valve anchoring device in the heart in a preferred embodiment disclosed in Example 2 of the present invention;

Fig. 13 is a diagram of the use state of the heart valve replacement system in the heart in a preferred embodiment disclosed in Example 2 of the present invention;

Fig. 14 is a cross-sectional view of the artificial heart valve and the valve anchoring device in a preferred embodiment disclosed in Example 3 of the present invention;

Fig. 15 is a diagram of the cooperation state of the artificial heart valve and the valve anchoring device in a preferred embodiment disclosed in Example 4 of the present invention;

Fig. 16 is a sectional view of Fig. 15;

Fig. 17 is a diagram of the cooperation state of the artificial heart valve and the valve anchoring device in a preferred embodiment disclosed in Example 5 of the present invention;

FIG. 18 is a cross-sectional view of FIG. 17 .

Explanation of reference signs:

Valve support 100, main body 110, protrusion 120, anchoring arm 130, skirt 140;

Valve anchoring device 200, ring members 210, 210', elastic connector 220, recess 230;

Left atrium 300, left ventricle 400, native leaflet 500, chordae 600.

Detailed ways

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 specific embodiments of the present invention and 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 states otherwise.

In the description of the present invention, it should be noted that unless otherwise specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it can be mechanically connected or magnetically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations. In addition, in the description of the present application, the terms "first", "second" and the like are only used to distinguish descriptions, and cannot be understood as indicating or implying relative importance.

Apparently, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

In order to solve the problems existing in the prior art, an embodiment of the present invention provides a transcatheter heart valve replacement system, the system includes an artificial heart valve and a valve anchoring device 200; the valve anchoring device 200 includes a fixing part, and the fixing part includes At least one annular member 210; the valve anchoring device 200 can be positioned on the outside of the native valve chordae 600, and conform to the change in the shape of the native valve ring; the artificial heart valve includes a valve support 100, and at least a part of the valve support 100 defines a blood supply The flow channel of circulation; the artificial heart valve can be positioned on the inside of the original valve, and replace the physiological function of the original valve; at least part of the valve support 100 cooperates with the ring member 210; the valve support 100 and the ring member 210 cooperate with each other. A mating state, a second mating state, the first mating state and the second mating state are set at intervals in the circumferential direction; the first mating state is configured as: the valve support 100 and the ring member 210 abut against each other, and the two are interference fit or excessive Fit; the second fit state is configured as follows: there is a gap between the valve support 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 600 or the native leaflet 500 .

Example 1

In order to solve the problems existing in the prior art, this embodiment provides a transcatheter heart valve replacement system, which can be applied to any valve in the heart; Cube replacement is used as an example.

1-5, the heart valve replacement system includes an artificial heart valve and a valve anchoring device 200; the artificial heart valve at least includes a metal valve support 100 and artificial valve leaflets, the valve support 100 has a main body 110, and in the main body 110 A flow channel for blood circulation is defined; the valve anchoring device 200 includes a fixed part, and the fixed part has one or more annular members 210, which can be implanted at the chordae 600 plexus of the mitral valve and can provide at least a radial effect Force, to cooperate with the artificial heart valve implanted in the mitral valve, and interact with it, the cooperation of the two can reduce the size of the natural mitral valve, reduce mitral valve regurgitation; at the same time, the valve anchoring device 200 can fasten Anchoring the position of the artificial heart valve effectively prevents the displacement of the artificial heart valve during myocardial movement.

Preferably, the artificial valve leaflet is made of a commercially available porcine aortic valve, bovine pericardial valve or porcine pericardial valve, or is made of a biocompatible polymer material to replace the physiological function of the original valve leaflet 500; Preferably, the artificial valve leaflet is sewn on the inner side of the valve support 100 .

In a preferred embodiment, the valve stent 100 is made of biocompatible metal, has two forms, collapsed and expanded, and can be delivered in the human body in the collapsed form, and can be inflated by a balloon, The mechanical dilator or its own shape memory property expands radially, and after being implanted in the heart and expands, it is roughly in the shape of a network tube, the middle part of which penetrates the defined space for blood to flow; the valve stent 100 can be anchored at the original valve annulus, And accommodate artificial valve leaflets.

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 nickel-titanium alloy or copper-aluminum-nickel alloy; optionally, when the valve stent 100 is configured as a balloon In the case of an expandable or mechanically expandable stent, the valve stent 100 is made of materials such as stainless steel or cobalt-based alloy.

In a preferred embodiment, the valve stent 100 is a self-expanding stent, and the shape memory alloy material is processed, including but not limited to braiding, laser cutting, welding, rivet connection, thread connection, etc., to form multiple rows Interconnected polygonal grid structure; adjacent grid structures are connected by wave rods or nodes with certain elasticity, wherein the grid structure can be set as rhombus grid or hexagonal grid; preferably, the grid structure Both upper and lower diagonal corners are V-shaped.

As shown in Fig. 1, in a preferred embodiment, the main body 110 of the valve stent 100 is cylindrical or similar to a cylindrical structure, and can be positioned in the connection transition area between the original valve leaflet 500 and the chordae 600 of the mitral valve, and Cooperate with the valve anchoring device 200 .

Preferably, the cross-section of the main body 110 is circular, elliptical, D-shaped or other shapes suitable for the mitral valve annulus.

More preferably, the inflow end of the valve support 100 also has a skirt portion 140, the skirt portion 140 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 Including the skeleton part, optionally, the skeleton part of the skirt part 140 can be cut from a metal tube or braided from a metal wire; the outside of the skeleton part is covered with a sealing film to prevent paravalvular leakage. Both the main body portion 110 and the skirt portion 140 can be radially expanded and compressed to ensure that they are in a compressed state when delivered in blood vessels, and then open by self-expansion after reaching the mitral valve.

Referring to FIG. 2 , in a preferred embodiment, the valve anchoring device 200 includes several closed ring members 210 ′, adjacent ring members 210 ′ are elastically connected, and the adjacent ring members 210 are axially connected to each other. arranged in parallel to form a fixed part. Preferably, the plurality of annular members 210' do not deform radially, and are used to support the main body 110 of the valve stent 100, match and anchor with each other; and the elastic connectors 220 between adjacent annular members 210' can provide valve The axial deformability of the anchoring device 200 is adapted to the shape change of the myocardial tissue throughout the cardiac cycle.

Preferably, the ring member 210 is made of shape memory metal, preferably nickel-titanium alloy, and the elastic connector 220 is also made of shape memory metal, and is fixedly connected to the ring member 210' by welding or crimping. Preferably, there are multiple elastic connectors 220 symmetrically distributed along the circumferential direction of the annular member 210', and each elastic connector 220 is parallel to the axial direction of the valve anchoring device 200.

Preferably, the annular member 210' can be linearly arranged in the conveying device during transportation, and the two ends of the annular member 210' are provided with snap-in structures, and the snap-in structures can be set as pins and grooves, such as High l The connection structure in the ife, after reaching the left ventricle 400 and releasing the annular member 210', its shape is restored from a straight line to a ring, and the end to end is connected, and the snap-in structure at both ends completes a stable connection, realizing 200 pairs of valve anchoring devices Capture of native leaflet 500 .

Preferably, the valve anchoring device 200 includes at least two ring members 210', and the distance between adjacent ring members 210' is 1.0-5.0 mm; preferably, the axial length of the fixing part of the valve anchoring device 200 is the same as the The length of the main body 110 of the stent 100 is adapted; 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 .

Further, for different patients, the shape and size of the atrium/valve/ventricular will be different, and those skilled in the art can understand that the specific size of the valve anchoring device 200 and the number of ring members 210' provided Adaptive changes can be made according to the patient's condition.

As shown in FIG. 3 , in another preferred embodiment, the valve anchoring device 200 is configured in a substantially helical structure. Each helix is a ring-shaped member 210; on the one hand, the helical structure can provide both axial and radial deformation capabilities to adapt to changes in the shape of myocardial tissue throughout the cardiac cycle. It is also more convenient. On the other hand, this structure can provide a radially inward contraction force to support, match and anchor the main body portion 110 of the valve stent 100 .

In a preferred embodiment, the valve anchoring device 200 is helically wound by a pre-shaped shape-memory metal, preferably a nickel-titanium alloy, which can be elastically deformed at least radially and axially to conform to changes in the shape of myocardial tissue When the valve anchoring device 200 is delivered, it can be delivered in a straight line in the human body, and can wrap around the chordae 600 after being released in the left ventricle 400 .

Preferably, the valve anchoring device 200 includes at least two ring members 210, and the distance between adjacent ring members 210 is 1.0-5.0 mm; preferably, the valve anchoring device 200 includes at least a fixing part, and the axial length of the fixing part is It 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 part and/or a ventricular fixing part, the distal ends of which extend toward the atrium or ventricle respectively, for better positioning the valve anchoring device 200 on the patient. at the heart valve.

Further, for different patients, the shape and size of the atrium/valve/ventricle will be different. Those skilled in the art can understand that the specific size of the valve anchoring device 200 and the number of ring members 210 provided can vary. Adaptive changes according to the patient's condition.

In this embodiment, the ring member 210 with a spiral structure is preferably used as an example for illustration, but it can be understood that the same configuration in this embodiment is also applicable to the ring member 210 with a closed loop structure.

With reference to Fig. 4, Fig. 5, preferably, the partial area of valve support 100 cooperates with annular member 210; 2. Set the circumferential interval in the matching state. Preferably, the first fit state is configured as follows: the valve stent 100 and the ring member 210 abut against each other, and the two are an interference fit or over fit; preferably, the second fit state is configured as: the valve support 100 and the ring member 210 There is a gap between them, and the two form a gap fit, and the gap between the valve support 100 and the ring member 210 is used to accommodate the chordae 600 or the native valve leaflet 500 .

Preferably, the gap formed by the second mating state is used to accommodate the chordae 600. Taking the mitral valve as an example, the chordae 600 at the mitral valve of the human body are mostly distributed at both ends of the aortic valve leaflet and the wall leaflet (A1 P1 and A3P3); in a preferred embodiment, when both the artificial heart valve and the valve anchoring device 200 are implanted in the patient's body, by adjusting the angle and position of the two, the position of the second mating state is consistent with that of the tendon The positions of the cords 600 are coincident, and the cords 600 can pass through the gap between the valve support 100 and the ring member 210, so as to prevent the prosthetic heart valve and the valve anchoring device 200 from squeezing and rubbing the cords 600.

Preferably, a raised portion 120 is provided in a partial area of the main body 110 of the valve stent 100, and the raised portion 120 protrudes along the radial direction of the main body 110 for abutting against the ring member 210 to form a first mating state ; The area where the protrusion 120 is not provided can be clearance fit with the ring member 210 to form a second fit state.

Preferably, the raised portion 120 is arched and arranged on the outer periphery of the main body 110, and the inner surface of the raised portion 120 is adapted to the outer peripheral contour of the main body 110, so as to ensure that the raised portion 120 can accompany the main body 110 of the valve stent 100 The expansion and contraction changes synchronously, which is convenient to control 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 abnormal contour.

Preferably, at least two protrusions 120 are arranged at intervals in the circumferential direction of the main body 110, and the arc length of each protrusion 120 is not greater than half of the circumference of the main body 110. This arrangement can ensure that the protrusions 120 and the protrusions There is a gap between the parts 120, and after being fitted with the valve anchoring device 200, it is convenient for the chordae 600 or the original valve leaflet 500 to pass through the gap, as shown in FIG. 5 . More preferably, after mating with the valve anchoring device 200 , the gap cross-sectional size of the adjacent protrusion 120 in the circumferential direction needs to be larger than the cross-sectional size of the chordae 600 or the native valve leaflet 500 here.

In a preferred embodiment, the length of the raised portion 120 in the vertical direction is not less than the width of the fixed portion in the vertical direction, that is, when there are multiple ring-shaped members in the fixed portion, the raised portion 120 is vertically The length in the direction is not less than the width of a plurality of ring members in the vertical direction, so that the protruding part 120 and each ring member 210 of the fixing part can have a first mating state and a second mating state, ensuring that the chordae 600 or The native valve leaflet 500 can pass through the gap between the protruding part 120 and the fixing part. More preferably, the second mating state formed by the protruding part 123 and the ring member 210 can at least ensure the passing of the chordae 600 .

In another preferred embodiment, the length of the protruding portion 120 in the vertical direction is not less than the width of the ring member 210 in the vertical direction, that is, when there are multiple ring members in the fixing portion, each ring member 210 Protruding parts 120 are provided at the abutting parts of the main body part 110; preferably, several protruding parts 120 are arranged along the circumference of the valve support 100, and then each protruding part 120 arranged in the circumferential direction is distributed more axially along the same axis. The number of protrusions 120 in the axial direction is the same as the number of ring members 210 on the fixing part, so as to ensure that the number and position of the protrusions 120 correspond to the ring members 210 one by one.

In a preferred embodiment, each annular member 210 is provided with a raised portion 120 at the abutting portion of the main body portion 110, and the plurality of axially arranged raised portions 120 are arranged on the same axis, further, the axially arranged The thickness of the plurality of protrusions 120 gradually increases from the annulus to the ventricle, that is, in the vertical direction, the thickness of the protrusions 120 gradually increases from top to bottom, so as to ensure that the valve support 100 at least in the chordae There can be a gap at 600 from the ring member 210 to accommodate the chord 600 . In a preferred embodiment, the adjacent protrusions 120 are equidistantly arranged; in another preferred embodiment, the adjacent protrusions 120 are not equidistantly arranged; more preferably, due to the mitral valve The anterior leaflet 500 of the native leaflet 500 is large and the posterior leaflet is small, so the size and/or volume of the chordae 600 connected to the anterior leaflet and the posterior leaflet are different. When two protrusions 120 are provided, the two protrusions 120 forms a slightly larger gap at one end for accommodating a larger size/volume chord 600; the two protrusions 120 form a slightly smaller gap at the other end for accommodating a smaller size/volume chord 600.

Preferably, the plurality of protrusions 120 may have the same or different arc lengths, and the size of the gap formed between adjacent protrusions 120 may be changed by varying the arc lengths and positions of the plurality of protrusions 120 .

Preferably, the protrusions 120 have the same or different protrusion thicknesses in the circumferential direction; taking two protrusions 120 as an example, when the anterior leaflet and the posterior leaflet of the original mitral valve leaflet 500 are connected, the chordae 600 When the size difference is large, the protrusion thickness of the raised portion 120 is preferably thicker at one end and slightly thinner at the other end, and the other raised portion 120 is also set to be thicker at one end and slightly thinner at the other end, and the thicker end is opposite to the thinner end. In contrast, after the thicker protrusion 120 abuts against the ring member 210, it can form a larger gap with the adjacent protrusion 120 for accommodating the larger size/volume chordae 600, while the thicker After the thin protrusion 120 abuts against the ring member 210 , it can form a smaller gap with the adjacent protrusion 120 for accommodating the chord 600 with smaller size/volume.

Optionally, the protruding part 120 is made of hard polymer material or metal material, and is fixed to the main body part 110 by bonding, welding, hinged, welded, hinged, riveted or integrally formed.

Preferably, a first connecting piece is provided on the valve support 100 , the first connecting piece has a tendency to extend toward the fixing portion, it can pierce or not pierce the original valve leaflet 500 , and cooperate with the ring member 210 .

In a preferred embodiment, the first connecting member is arranged on the grid structure of the main body portion 110 of the valve stent 100 without the raised portion 120; in another preferred embodiment, the first connecting member is arranged on the valve stent In the region of the raised part 120 , the first connecting part can be fixed on the grid structure and penetrate through the raised part 120 , or the first connecting part can be arranged on the outer surface of the raised part 120 .

In a preferred embodiment, the first connecting piece is configured as several anchoring arms 130. Preferably, the several anchoring arms 130 can be attached to the valve support 100 or the protrusion 120 in the compressed state of the valve support 100. The outer surface extends radially outward of the valve support 100 in the released state and penetrates at least into the native valve leaflet 500, more preferably, the anchoring arm 130 passes through the native valve leaflet 500 and is stabilized with the valve anchoring device 200 Abut.

Preferably, the anchoring arm 130 can be made of memory alloy, polymer, fiber or other polymer materials, and is fixed on the outer surface of the valve support 100 or the protrusion 120 by welding, crimping or riveting.

Optionally, the anchoring arm 130 extends radially outward toward the direction of the outflow end; preferably, the anchoring arm 130 extends radially outward and toward the direction of the inflow end, corresponding to the middle of the mitral valve, that is, extending radially obliquely upward , forming a barb-like structure. When the anchoring arm 130 passes through the native valve leaflet 500, it can abut against the underside of the annular member, so that the valve support 100 and the valve anchoring device 200 are closely combined and generate a stable anchoring force, preventing the valve support 100 from Displacement occurs during the cardiac cycle.

Optionally, the shapes, sizes, and inclination angles of the anchor arms 130 arranged at different positions may be the same or different from each other; optionally, the anchor arms 130 may be arranged in one or more rows of grid structures , and can be circumferentially symmetrically distributed or circumferentially staggeredly distributed.

In a preferred embodiment, the first connecting piece is configured as several magnetic components; preferably, the magnetic components are arranged on the outer surface of the valve support 100 or the outer surface of the raised portion 120 or the inner surface of the raised portion 120 close to the outside The interior of the surface.

Preferably, the ring member 210 is made of ferromagnetic metal material, so even if only the magnetic member is provided on the valve support 100 , the magnetic attraction between the ring member 210 and the valve support 100 can be realized.

Preferably, the magnetic member can be made of neodymium-iron-boron alloy, which has the characteristics of small size, light weight and strong magnetism, in order to provide greater magnetic attraction.

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

Preferably, the second connecting piece is also configured as a plurality of magnetic members, and the magnetic members are arranged on the outer surface of the fixing part or close to the inner surface of the outer surface; more preferably, when both the ring member 210 and the valve support 100 are provided with magnetic members At this time, the magnetic members can be distributed symmetrically or staggered along the circumference, but it is necessary to ensure that the positions match each other, so as to ensure that the ring member 210 and the valve support 100 can attract each other.

Preferably, when the magnetic member is only provided on the main body portion 110 of the valve stent 100, the ring member 210 must be provided with a ferromagnetic material at least in the section corresponding to the first connecting part; When a magnetic member is used, the main body part 110 of the valve stent 100 must be provided with a ferromagnetic material at least in the section corresponding to the second connecting part.

In this embodiment, the above-mentioned transcatheter heart valve replacement system is used as follows:

When the valve anchoring device 200 is delivered, it is arranged in the delivery device in a straight line, and the delivery device reaches the left ventricle 400 through the blood vessel or the apex, and the valve anchoring device 200 is delivered to the mitral valve chordae 600 and the left ventricle 400 between walls. The valve anchoring device 200 passes through the gap between the chordae 600 and the wall of the left ventricle 400 , is delivered along the wall of the left ventricle 400 , and finally wraps around the chordae 600 , as shown in FIG. 12 . On the one hand, it realizes the capture of the mitral valve leaflet, and on the other hand, it provides an anchor point for the subsequent implantation of the artificial heart valve.

The prosthetic heart valve is compressed by the conveyor and then released through the femoral vein through the interatrial septum to reach the mitral valve. The protruding part 120 of the valve support 100 abuts against the radial inner side of the fixed part of the valve anchoring device 200 , to form the first mating state; the area of the main body 110 without the raised portion 120 is in clearance fit with the valve anchoring device 200 to form a second mating state, at this time, the gap between the main body 110 and the valve anchoring device 200 can be used To accommodate the original valve leaflet 500 or the chordae 600; the first connecting piece on the main body 110 expands radially outwards and abuts against the lower side of the ring-shaped member, and the further anchoring of the artificial heart valve is realized through the friction force between the two ; The skirt portion 140 is correspondingly arranged on the left atrium 300 side of the mitral valve to prevent paravalvular leakage and reduce surgical risks, as shown in FIG. 13 .

Since the prosthetic heart valve is provided with at least two protrusions 120, there are at least two gaps between the prosthetic heart valve and the valve anchor. Before the prosthetic heart valve is completely released, its direction is changed by rotation to make the gap At the patient's chordae 600 (such as A1 P1 and A3P3 of the mitral valve), finally the chordae 600 can pass through the gap, avoiding the prosthetic heart valve and the valve anchoring device 200 from squeezing or rubbing the chordae 600, causing the chordae 600's tear.

Example 2

Referring to Figures 9-13, still taking mitral valve implantation as an example, in this embodiment, a transcatheter heart valve replacement system is provided, which also includes an artificial heart valve and a valve anchoring device 200, preferably The protruding part 120 is no longer provided on the outside of the artificial heart valve, as shown in Figure 6, and other structures are the same as in the above-mentioned embodiment 1; 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 the above-mentioned embodiment 1 are naturally inherited in this embodiment, and will not be repeated here.

As shown in Fig. 7 and Fig. 8, preferably, the valve anchoring device 200 includes several annular members 210, and the inner periphery of the annular members 210 is provided with a recessed portion 230, and the recessed portion 230 can be clearance-fitted with the main body portion 110 of the valve stent 100 to form In the second mating state, the original valve leaflet 500 or the chordae 600 can be accommodated in the gap between the two; the area without the recessed part 230 can abut against the main body 110 to form the first mating state, refer to Fig. 9-Fig. 11 .

In a preferred embodiment, the concave portion 230 is configured as a diameter-reducing section on the ring member 210, and the diameter-reducing section is in a waist shape; the gap between the diameter-reducing section and the main body 110 is used to accommodate the chordae 600. Specifically, at least one side of the reducing section facing the main body 110 is in a waist shape. Preferably, after the valve anchoring device 200 cooperates with the artificial heart valve, the cross-sectional size of the gap between the recessed part 230 and the artificial heart valve needs to be larger than the cross-sectional size of the chordae 600 here.

In a preferred embodiment, each annular member 210 is provided with at least two recessed portions 230 at intervals in the circumferential direction, and adjacent recessed portions 230 are equidistantly or unequally spaced. Specifically, each concave portion 230 corresponds to at least one or several chordae 600 , and the position of the concave portion 230 on the ring member 210 matches the position of the chordae 600 .

Since the anterior leaflet 500 of the original mitral valve leaflet 500 is large and the posterior leaflet is small, there is a difference in the size and/or volume of the chordae 600 connecting the anterior leaflet and the posterior leaflet, so optionally, each depression 230 may have the same or different arc lengths; alternatively, each concave portion 230 may have the same or different variable diameter sizes; so as to adapt to different shapes/sizes/volumes of the chordae 600 .

Preferably, the fixing part has at least two ring members 210, and the positions of the recesses 230 on adjacent ring members 210 correspond to each other. That is, a plurality of recesses 230 are arranged along the circumference of one ring member 210, and then the recesses 230 on adjacent ring members 210 are axially arranged along the same axis, and the positions of the recesses 230 in the axial direction correspond one-to-one to ensure The chord 600 can pass through the gap formed by the recesses 230 on several ring members 210 , avoiding that the positions of the recesses 230 on adjacent ring members 210 are staggered so that the chord 600 cannot pass through.

In this embodiment, the above-mentioned transcatheter heart valve replacement system is used as in the above-mentioned embodiment 1, the difference is that before the valve anchoring device 200 is completely released, its direction is adjusted by rotation so that the concave part 230 corresponds to the patient's tendon chord 600 (such as A1 P1 and A3 P3 of the mitral valve), finally allowing the chord 600 to pass through the gap, avoiding the prosthetic heart valve and the valve anchoring device 200 from squeezing or rubbing the chord 600, causing tearing of the chord 600 .

Example 3

Still taking mitral valve implantation as an example, in this embodiment, a transcatheter heart valve replacement system is provided, which also includes an artificial heart valve and a valve anchoring device 200, which have been described in the above-mentioned embodiment 1 Features are naturally inherited in this embodiment.

As shown in FIG. 14 , preferably, the outer side of the valve support 100 is provided with a raised portion 120 , and the annular member 210 is provided with a recessed portion 230 , and the raised portion 120 and the recessed portion 230 are alternately arranged in the circumferential direction. More preferably, after the valve anchoring device 200 is fitted with the artificial heart valve, a recessed portion 230 is provided on the annular member 210 corresponding to the area of the main body 110 where no protrusion 120 is provided, so that adjacent protrusions 120 can be Make way for a larger gap to further increase the space for accommodating the chordae 600 .

Example 4

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

Referring to Fig. 15 and Fig. 16, preferably, in the cross section of the main body part 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 A mating state; separated in some sections, the separated area is the second mating state, and the separated area is used to accommodate the chordae 600 or the original leaflet 500 .

Optionally, the cross-section of the main body 110 is circular, and the cross-section of the fixing part is oval, triangular, D-shaped, etc., and at least two tangent points between the main body 110 and the cross-section of the fixing part are ensured. Those skilled in the art should understand that if there is only one tangent point in the cross section of the main body part 110 and the fixing part, it means that the sizes of the two do not match, and they cannot be anchored to each other at the original valve annulus.

In a preferred embodiment, the cross-section of the main body 110 is circular, and the cross-section of the fixing portion is elliptical. The two have two tangent points, and the other areas are separated; The distance from the region is the second mating state; preferably, the minor axis of the ellipse in the cross-section of the fixed part should not be greater than the diameter of the cross-section of the main body 110, so as to ensure that the fixed part and the main body 110 can be over-fit or interference-fit at the tangent point , so that the two can be stably matched; preferably, the major axis of the ellipse in the cross-section of the fixing part should be larger than the diameter of the cross-section of the main body 110, so as to ensure that the chord 600 can pass through the gap between the fixing part and the main body 110 .

In another preferred embodiment, the cross section of the main body part 110 is circular, and the cross section of the fixing part is triangular in shape. The two have three tangent points, and the other areas are separated; the tangent point is the first mating state, The separated area is the second mating state; the space between adjacent tangent points corresponds to the separated area, and also corresponds to the three protruding corners of the triangular ring, and the space is used to accommodate the chord 600 .

In this embodiment, the above-mentioned transcatheter heart valve replacement system is used as in the above-mentioned embodiment 1, the difference is that before the valve anchoring device 200 is completely released, its direction is adjusted by rotation so that its outwardly protruding area corresponds to At the patient's chordae 600 (such as A1 P1 and A3P3 of the mitral valve), the chordae 600 can finally 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 squeezes or rubs against chord 600 , causing tearing of chord 600 .

Example 5

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

Referring to Fig. 17 and Fig. 18, preferably, in the cross section of the main body part 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 A mating state; separated in some sections, the separated area is the second mating state, and the separated area is used to accommodate the chordae 600 or the original leaflet 500 .

Preferably, the cross-section of the fixing part is circular, the cross-section of the main body 110 is oval or D-shaped, and it is ensured that there are at least two tangent points between the main body 110 and the cross-section of the fixing part, and the gap between the tangent points is used To accommodate 600 chordae. Those skilled in the art should understand that if there is only one tangent point in the cross section of the main body part 110 and the fixing part, it means that the sizes of the two do not match, and they cannot be anchored to each other at the original valve annulus.

Different from the above-mentioned Embodiment 4, at this time, it is not selected to set the cross section of the main body 110 as another polygon, otherwise the blood flow may be affected. The reason why the cross-section can be set as D-shaped is that the cross-section of the original mitral valve is mostly D-shaped, so this setting can be more suitable for the patient's original valve.

Preferably, the major axis of the ellipse in the cross-section of the main body 110 should not be smaller than the diameter of the cross-section of the fixed part, so as to ensure that the fixed part and the main body 110 can be over-fit or interference-fit at the tangent point, so that the two can be stably matched Preferably, the minor axis of the ellipse in the cross section of the main body 110 should be smaller than the diameter of the cross section of the fixed part, so as to ensure that the chord 600 can pass through the gap between the fixed part and the main body 110 .

In this embodiment, the above-mentioned transcatheter heart valve replacement system is used as in the above-mentioned embodiment 1, the difference is that before the artificial heart valve is completely released, its direction is adjusted by rotation so that the chordae 600 can pass through the valve anchoring device 200 The gap between the prosthetic heart valve and the prosthetic heart valve prevents the prosthetic heart valve and the valve anchoring device 200 from squeezing or rubbing the chordae 600 , causing tearing of the chordae 600 .

Embodiments of the present invention have been described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementations, and the above-mentioned specific implementations are only illustrative, rather than restrictive, and those of ordinary skill in the art will Under the enlightenment of the present invention, without departing from the gist of the present invention and the protection scope of the claims, many forms can also be made, all of which belong to the protection of the present invention.

Claims (20)

1. A transcatheter heart valve replacement system, comprising an artificial heart valve and a valve anchoring device; The valve anchoring device includes a fixing part, and the fixing part includes at least one annular member; the valve anchoring device can be positioned on the outside of the native valve chordae, and conforms to changes in the shape of the native valve ring; The artificial heart valve includes a valve stent, at least a part of the valve stent defines a flow channel for blood circulation; the artificial heart valve can be positioned on the inner side of the original valve, and replace the physiological function of the original valve; At least a partial area of the valve support cooperates with the ring member; the position where the valve support cooperates with the ring member includes a first mating state and a second mating state, and the first mating state is matched with the second mating state. Coordinate state circumferential interval setting; The first fit state is configured as follows: the valve support and the annular member abut against each other, and the two are interference fit or over fit; The second mating state is configured as follows: there is a gap between the valve support and the ring member, and the two are in a gap fit; the gap between the two is used to accommodate the chordae or the native valve leaflet. 2. The transcatheter heart valve replacement system according to claim 1, wherein the valve support comprises a main body, and at least a partial area of the main body cooperates with the annular member; The outer periphery of the main body is provided with a convex part, and/or, the inner periphery of the ring member is provided with a concave part; The protrusion protrudes along the radial direction of the main body for forming the first mating state with the ring member, and the area where the protrusion is not provided can form the ring member with the ring member. second mating state; The recessed portion is recessed along the radial direction of the ring member for forming the second mating state with the main body portion, and the area where the recessed portion is not provided can form the first mating state with the main body portion state. 3. The transcatheter heart valve replacement system according to claim 2, wherein a protrusion is provided on the outer periphery of the main body, and a recess is provided on the inner periphery of the ring member; the protrusion and The depressions are arranged in a staggered manner in the circumferential direction. 4. The transcatheter heart valve replacement system according to claim 2, wherein the raised portion is arched and arranged on the outer periphery of the main body, and the inner surface of the raised portion is in contact with the main body. Compatible with the outer peripheral contour; The arc length of the protruding portion is not greater than half of the circumference of the main body; the vertical length of the protruding portion is not less than the vertical width of the fixing portion. 5. The transcatheter heart valve replacement system according to claim 4, wherein the main body part is provided with at least two protrusions, and the adjacent protrusions are equally or unequally spaced Setting; between the adjacent protrusions is used to accommodate the chordae or native valve leaflets. 6. The transcatheter heart valve replacement system according to claim 4, wherein the main body part is provided with at least two raised parts; the raised parts have equal or unequal wall thickness in the circumferential direction. Thickness is set, and/or, the said raised part is set in the axial direction with equal wall thickness or unequal wall thickness. 7. The transcatheter heart valve replacement system according to any one of claims 2-6, characterized in that, the raised portion comprises a hard polymer material or a metal material, and is bonded, welded, hinged, welded, It is fixedly connected with the main body in the way of hinge joint, riveting or integral forming. 8. The transcatheter heart valve replacement system according to claim 2, wherein the concave portion is configured as a diameter-reducing section on the ring member, and the diameter-reducing section is waist-shaped; The gap between the reduced-diameter section and the main body is used for accommodating the chordae tendineae or native leaflets. 9 . The transcatheter heart valve replacement system according to claim 8 , wherein the annular member is provided with at least two of the depressions, and the adjacent depressions are equidistant or unequal. 10. The transcatheter heart valve replacement system according to claim 8 or 9, wherein the fixing part is provided with at least two ring members, and the positions of the recesses on adjacent ring members are mutually correspond. 11. The transcatheter heart valve replacement system according to claim 1, wherein the valve support comprises a main body; In the cross section of the main body part and the fixed part, one is circular, and the other is non-circular; the two are tangent in some sections, and separated from each other in some sections, and the separated area is used to accommodate Chordae or native leaflets. 12. The transcatheter heart valve replacement system according to claim 11, wherein the cross-section of the main body is circular, the cross-section of the fixing part is elliptical, and the two have two tangent points; Alternatively, the cross-section of the main body part is circular, and the cross-section of the fixing part is triangular in shape, and the two have three points of tangency; The space between the adjacent tangent points of the cross-section of the body portion and the fixation portion is used to accommodate the chordae or native valve leaflets. 13. The transcatheter heart valve replacement system according to claim 11, wherein the cross-section of the main body is oval or D-shaped, the cross-section of the fixing part is circular, and both have two Cut points; the space between the cut points is used to accommodate the chordae or native valve leaflets. 14. The transcatheter heart valve replacement system according to claim 2 or 11, wherein the valve support is provided with a first connecting piece, and the first connecting piece is arranged on the outer surface of the raised portion or On the outer surface of the main body part, the first connecting part has a tendency to extend toward the fixing part; the first connecting part pierces or does not pierce the original leaflet, and cooperates with the ring member; And/or, the fixing part is provided with a second connecting part, and the second connecting part has a tendency to extend toward the main part; the second connecting part pierces or does not pierce the original leaflet, and is compatible with the The main body parts cooperate with each other. 15. The transcatheter heart valve replacement system according to claim 14, wherein the first connecting piece comprises several anchoring arms, and the anchoring arms are arranged on the protrusion or the main body and extending radially outward; The anchoring arm is bent in a direction away from the blood flow; or, the anchoring arm is bent in a direction conforming to the blood flow. 16. The transcatheter heart valve replacement system according to claim 14, wherein the first connecting piece comprises several magnetic members, and the magnetic members are arranged on the outer peripheral surface of the protrusion or approach the outer periphery The interior of the surface. 17. The transcatheter heart valve replacement system according to claim 14, wherein the second connecting piece comprises several magnetic members, and the magnetic members are arranged on the outer surface of the fixing part or approach the outer surface internal. 18. The transcatheter heart valve replacement system according to claim 1, wherein the valve support comprises a main body portion 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; The body portion includes a number of interconnected polygonal mesh structures. 19. The transcatheter heart valve replacement system according to claim 1, wherein the fixing part comprises a plurality of ring members, and adjacent ring members are connected end to end, forming a helical structure. 20. The transcatheter heart valve replacement system according to claim 1, wherein the fixing part comprises a plurality of annular members, each of which is in a closed ring shape, and the axial direction of the plurality of annular members is They are arranged in parallel, and the adjacent ring members are elastically connected.

Images