Transcatheter replacement valve device and its stent

Abstract

The application provides a kind of replacement valve device and its support by catheterization, it is related to heart valve technical field.The replacement valve support by catheterization includes support main body, anchoring structure, skirt support structure and sealing membrane.The sealing membrane is circumferentially closed cylindrical structure, sealing membrane includes the first sealing section and the second sealing section being arranged along the axial direction and being connected with each other, the first sealing section is tightly arranged on part or all of skirt support structure, the second sealing section is tightly arranged on part or all of support main body;Sealing membrane is arranged on the inner side and / or outer side of skirt support structure and support main body.The application can solve the problem that sealing membrane and valve support do not fit in the prior art, poor sealing, leading to sealing membrane in blood, leading to paravalvular leakage or causing other complications, with high degree of fit, good sealing, can avoid sealing membrane in blood, effectively avoid paravalvular leakage or cause other complications.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of heart valve, in particular to a transcatheter replacement valve device and a stent. BACKGROUND

[0002] Transcatheter mitral valve replacement (TMVR) does not require thoracotomy, cardiopulmonary bypass or cardioplegia, greatly reducing surgical trauma, and has become another research hotspot after transcatheter aortic valve replacement (TAVR). In the existing transcatheter mitral valve replacement device, the sealing membrane on the valve stent does not fit the valve stent, the sealing performance is poor, the sealing membrane is filled with blood, and paravalvular leakage or other complications are caused. SUMMARY

[0003] The technical problem to be solved by the present application is to overcome the defects in the prior art that the sealing membrane does not fit the valve stent, the sealing performance is poor, the sealing membrane is filled with blood, and paravalvular leakage or other complications are caused, so as to provide a transcatheter replacement valve device and a stent thereof.

[0004] In order to solve the above problems, the present application provides a transcatheter replacement valve stent, which comprises a stent body, an anchoring structure, a skirt support structure and a sealing membrane. The stent body is a cylindrical frame structure that can be radially compressed and expanded, and has a compressed state and an expanded state; the anchoring structure is a frame structure arranged around the outer periphery of the stent body; when the stent body is in the expanded state, the anchoring structure expands towards the outside of the stent body to anchor the stent body; the skirt support structure is an annular frame structure, the skirt support structure is arranged at the first end of the stent body, and the diameter of the skirt support structure is not less than the diameter of the stent body; the sealing membrane is a cylindrical structure composed of a first sealing segment and a second sealing segment arranged in the axial direction and connected to each other, the first sealing segment is arranged on part or all of the skirt support structure, and the second sealing segment is arranged on part or all of the stent body; the sealing membrane is arranged on the inner side and / or the outer side of the skirt support structure and the stent body.

[0005] Optionally, the sealing membrane comprises a first sealing layer and a second sealing layer, the first sealing layer is arranged on the inner side of the stent body and the skirt support structure, and the second sealing layer is arranged on the outer side of the stent body and the skirt support structure.

[0006] Optionally, the first end of the first sealing layer and the second sealing layer extends to the end of the skirt support structure, and the second end of the first sealing layer extends to the second end of the stent body.

[0007] Optionally, the skirt support structure comprises an outward expanding segment and an inward retracting segment arranged in the axial direction, one end of the outward expanding segment is connected with the stent body, and the other end of the outward expanding segment expands towards the outside of the stent body; one end of the inward retracting segment is connected with the outward expanding segment, and the other end of the inward retracting segment retracts towards the inside of the stent body.

[0008] Optionally, the stent body is a rhombic grid structure composed of a plurality of support rods, and the sealing membrane is connected to the support rods.

[0009] Optionally, the anchoring structure is a closed frame structure; when the stent body is in the compressed state, the anchoring structure at least partially overlaps the stent body in the radial direction, so that the transcatheter replacement valve stent forms a double-layer frame structure when compressed.

[0010] Optionally, the anchoring structure includes a plurality of anchoring members arranged at intervals around the outer periphery of the stent body, the anchoring members are provided with fixed ends and free ends, the fixed ends are connected to the stent body; when the stent body is in the expanded state, the free ends expand outward along the radial direction of the stent body, and are adapted to provide radial anchoring force for the stent body.

[0011] Optionally, the anchoring member has at least two connecting portions, the anchoring member is connected to the stent body through the connecting portions to form the fixed end, and the adjacent two connecting portions are connected by a support portion to form a closed loop structure; when the stent body is in the expanded state, the support portion expands towards the outside of the stent body to anchor the stent body, and the support portion forms the free end.

[0012] Optionally, the support portion has a bending structure.

[0013] Optionally, the outer contour of the bending structure is a smooth curve.

[0014] Optionally, the anchoring member has a first connecting portion and a second connecting portion, the bending structure includes a first bending segment connected to the first connecting portion, and a second bending segment connected to the second connecting portion, the first bending segment and the second bending segment have a relative torsion angle therebetween, so that the anchoring structure forms a spiral closed frame structure.

[0015] Optionally, the relative torsion angle of the first bending segment and the second bending segment is 45°-135°.

[0016] Optionally, the relative torsion angle of the first bending segment and the second bending segment is 90°.

[0017] Optionally, the fixed end is connected to the second end of the stent body, and the free end extends towards the first end of the stent body, so that when the stent body is in the compressed state, at least one of the stent body and the anchoring structure is completely overlapped in the radial direction with the other.

[0018] Optionally, the anchoring member includes an anchoring rod, both ends of the anchoring rod are fixed ends, and the middle of the anchoring rod is bent to form a free end.

[0019] Optionally, a reinforcing structure is connected between the adjacent two anchoring members.

[0020] Optionally, the reinforcing structure comprises reinforcing rods, the reinforcing rods are in one or more combinations of V-shaped, U-shaped, W-shaped, and two ends of the reinforcing rods are connected with two adjacent anchor members respectively.

[0021] Optionally, the second end of the stent body and / or the skirt structure is provided with a conveying connection structure, the conveying connection structure comprises a plurality of connection rods arranged around the stent body, the first end of the connection rod is connected with the second end of the stent body and / or the skirt structure, the second end of the connection rod extends away from the first end along the axial direction of the stent body, and a hooking part is arranged at the end portion, the hooking part is suitable for being connected with a conveying system.

[0022] Another aspect of the present application provides a transcatheter replacement valve device comprising the transcatheter replacement valve stent of any one of the above technical solutions.

[0023] Optionally, an artificial valve is arranged on the inner side of the stent body, the artificial valve is sutured and connected to the sealing membrane; the artificial valve is provided with two pieces, suitable for replacing the mitral valve of a patient; or the artificial valve is provided with three pieces, suitable for replacing the aortic valve of a patient; or the artificial valve is provided with four pieces, suitable for the heart valve of a special patient.

[0024] The present application has the following advantages:

[0025] 1. By using the technical solution of the present application, since the sealing membrane is provided with a first sealing section and a second sealing section, the first sealing section of the sealing membrane can be attached to the skirt structure, and the second sealing section of the sealing membrane can be attached to the stent body. Through this upper and lower segmented structure, the present application can make the attachment of the sealing membrane, the skirt structure and the stent body more high, and the sealing performance better, effectively avoiding paravalvular leakage or causing other complications.

[0026] 2. The sealing membrane is provided with two layers, the first sealing layer is tightly arranged on the inner side of the stent body and the skirt structure, and the second sealing layer is tightly arranged on the outer side of the stent body and the skirt structure. The first sealing layer and the second sealing layer cover the skirt structure and the stent body. In this way, the inner and outer sides of the stent body and the skirt structure are tightly arranged with the sealing membrane, further improving the sealing performance of the sealing membrane, and avoiding the blood in the sealing membrane, further reducing the probability of paravalvular leakage.

[0027] 3. The first end of the first sealing layer extends to the end portion of the skirt structure, and the second end of the first sealing layer extends to the second end of the stent body. The area covered by the sealing membrane of the stent body is increased, which can further improve the sealing performance of the transcatheter replacement valve stent and further prevent paravalvular leakage.

[0028] 4. The skirt support structure comprises an outwardly expanding section and an inwardly retracting section, the outwardly expanding section expands towards the outside of the stent body, and the inwardly retracting section retracts towards the inside of the stent body; the outwardly expanding section can facilitate the positioning of the transcatheter replacement valve stent after release, and can cooperate with the anchoring structure to hold the native valve leaflets, so as to anchor the stent body stably; the inwardly retracting section can first eliminate the sharp end of the outwardly expanding section after the stent body is compressed, so that the whole structure can be released from the delivery system more smoothly; secondly, the inwardly retracting section and the outwardly expanding section are reversely bent, and the inwardly retracting section applies an internal force to the outwardly expanding section; when the native valve leaflets are held by the anchoring structure, the inwardly retracting section can apply a force from the atrium to the ventricle to the outwardly expanding section, so as to enhance the holding force of the anchoring structure and the skirt support structure on the native valve leaflets, and make the transcatheter replacement valve stent anchor more stably; finally, the inwardly retracting section can also effectively prevent the problem of myocardial injury caused by the shrinkage of the left atrium after compensation disappears after surgical treatment.

[0029] 5. By arranging the sealing film, the artificial valve can be directly sewn on the sealing film; on the one hand, since the edge of the artificial valve is arc-shaped, direct sewing on the sealing film can be sewn along the shape, so as to ensure better sealing performance of the sewing and prevent paravalvular leakage; on the other hand, the stent body does not need to be provided with a larger sewing window for sewing the artificial valve, so that the width of the support rod has higher consistency and the mechanical properties are more uniform; at the same time, since the sewing window for the valve leaflet is cancelled and the width of the support rod is reduced, the radial size of the stent body is smaller after being compressed, so that a smaller diameter delivery system can be used during the operation, and the passability in the blood vessel is better.

[0030] 6. The delivery connection structure is arranged on the second end of the stent body and / or the skirt support structure, so that the transcatheter replacement valve device can meet two access methods of transseptal and transapical, and the appropriate access method can be selected according to the actual situation of the patient, so as to improve the difficulty of transcatheter replacement valve surgery. BRIEF DESCRIPTION OF DRAWINGS

[0031] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the description of the specific embodiments or the prior art. Obviously, the drawings described below are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0032] Figure 1 A structure schematic view of the transcatheter replacement valve stent provided by the embodiment of the present application is shown (including a stent body, a skirt support structure and a sealing film);

[0033] Figure 2 A structure schematic view of the transcatheter replacement valve stent provided by the embodiment of the present application is shown (including a stent body, a skirt support structure and a sealing film); Figure 1 A radial cross-sectional view of the transcatheter replacement valve stent provided by the embodiment of the present application is shown.

[0034] Figure 3 a top view of the Figure 1 ;

[0035] Figure 4 a front view of the Figure 1 with the sealing film removed;

[0036] Figure 5 a front view of the Figure 4 ;

[0037] Figure 6 a top view of the Figure 4 ;

[0038] Figure 7 a structural schematic diagram of a transcatheter replacement valve stent provided by an embodiment of the application (including a stent body, a skirt support structure, and an anchoring structure);

[0039] Figure 8 a radial section view of the Figure 7 ;

[0040] Figure 9 a top view of the Figure 7 ;

[0041] Figure 10 a perspective view of the anchoring structure in the Figure 7 ;

[0042] Figure 11 a top view of the anchoring structure in the Figure 7 ;

[0043] Figure 12 a structural schematic diagram in a release process;

[0044] Figure 13 a structural schematic diagram of a working state of the transcatheter replacement valve device after release.

[0045] Explanation of reference signs:

[0046] 1, support body; 2, anchoring structure; 21, anchor; 211, anchor rod; 212, connecting part; 2121, first connecting part; 2122, second connecting part; 213, supporting part; 214, bending structure; 2141, first bending section; 2142, second bending section; 3, skirt support structure; 31, outward expansion section; 32, inward contraction section; 33, grid opening; 4, reinforcing structure; 41, reinforcing rod; 5, delivery connection structure; 51, connecting rod; 52, hanging part; 6, sealing membrane; 61, first sealing layer; 611, first sealing section; 612, second sealing section; 62, second sealing layer; 7, artificial valve; 8, autologous valve leaflet; 9, left atrium; 10, left ventricle; 20, myocardial tissue; 30, atrial septum; 40, bending sheath; 50, suture. DETAILED DESCRIPTION

[0047] The technical solutions of the present application will be described in detail below with reference to the drawings. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0048] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", "third" are only for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0049] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0050] In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0051] In order to facilitate the introduction of the technical solutions of the present application, the following will be described in detail in combination with the drawings and specific embodiments, but the embodiments should not be regarded as limiting the present application.

[0052] Embodiment 1

[0053] The transcatheter replacement valve stent provided by the application is suitable for aortic valve replacement or mitral valve replacement. The technical solutions of the application are described below by taking a mitral valve replacement valve stent as an example.

[0054] With reference to Figures 1-13 The transcatheter replacement valve stent comprises a stent body 1, an anchoring structure 2, a skirt support structure 3, and a sealing membrane 6. The stent body 1 is a cylindrical frame structure that can be radially compressed and expanded, and has a compressed state and an expanded state. The anchoring structure 2 is a frame structure arranged around the outer periphery of the stent body 1. When the stent body 1 is in the expanded state, the anchoring structure 2 expands towards the outer side of the stent body 1 to anchor the stent body 1. The skirt support structure 3 is an annular frame structure, and the skirt support structure 3 is arranged at the first end of the stent body 1. The diameter of the skirt support structure 3 is not less than the diameter of the stent body 1. The sealing membrane 6 is a circumferentially closed cylindrical structure, and the sealing membrane 6 comprises a first sealing section 61 and a second sealing section 62 arranged in the axial direction and connected to each other. The first sealing section 61 is arranged in close contact with part or all of the skirt support structure 3, and the second sealing section 62 is arranged in close contact with part or all of the stent body 1. The sealing membrane 6 is arranged on the inner side and / or the outer side of the skirt support structure 3 and the stent body 1.

[0055] According to the technical solutions of the application, the first sealing section 61 of the sealing membrane 6 can be in close contact with the skirt support structure 3, and the second sealing section 62 of the sealing membrane 6 can be in close contact with the stent body 1, because the sealing membrane 6 is provided with the first sealing section 61 and the second sealing section 62. The sealing membrane 6 of the application has a higher close contact degree with the skirt support structure 3 and the stent body 1, and has better sealing performance, which effectively avoids paravalvular leakage or causes other complications.

[0056] Optionally, the stent body 1 is a rhombic lattice structure composed of a plurality of support rods, and the sealing membrane 6 is connected to the support rods.

[0057] Specifically, in this embodiment, the sealing membrane 6 comprises a first sealing layer 61 and a second sealing layer 62. The first sealing layer 61 is arranged on the inner side of the stent body 1 and the skirt support structure 3, and the second sealing layer 62 is arranged on the outer side of the stent body 1 and the skirt support structure 3.

[0058] Since the sealing film 6 is provided with two layers, the first sealing layer 61 is tightly arranged on the inner side of the stent main body 1 and the skirt support structure 3, and can provide an attachment point for the connection of the artificial valve 7. Since the artificial valve 7 is arc-shaped, compared with being directly sewn on the support rod of the stent main body 1, the arrangement of the first sealing layer 61 can facilitate the close sewing of the artificial valve 7, and the sealing performance is better, which can prevent blood reflux on the inner side of the stent main body 1 and prevent paravalvular leakage. The second sealing layer 62 is tightly arranged on the outer side of the stent main body 1 and the skirt support structure 3, and the second sealing film 6 has a higher degree of adhesion to the heart tissue, which can prevent blood reflux from the outer side of the stent main body 1 and prevent paravalvular leakage. The first sealing layer 61 and the second sealing layer 62 cover the skirt support structure 3 and part or all of the stent main body 1, which further improves the sealing performance of the sealing film 6, and can avoid blood infusion in the sealing film 6, and further reduces the probability of paravalvular leakage.

[0059] Optionally, the first end of the first sealing layer 61 extends to the end of the skirt support structure 3, and the second end of the first sealing layer 61 extends to the second end of the stent main body 1. Referring to Figure 1 , the first sealing layer 61 covers the skirt support structure 3 and the stent main body 1 from the inner side. In this way, the area of the sealing film 6 covering the stent main body 1 is increased, which can further improve the sealing performance of the transcatheter replacement valve stent and further prevent paravalvular leakage.

[0060] The first end of the second sealing layer 62 extends to the end of the skirt support structure 3, and is sewn and connected with the first sealing layer 61 at the end of the skirt support structure 3. The second end of the second sealing layer 62 extends to the second end of the stent main body 1. In order to facilitate the connection of the anchoring structure 2 and the stent main body 1, the outer side of the second end of the stent main body 1 is exposed outside the second sealing layer 62, as shown in Figure 1 or Figure 2 , the exposed part of the stent main body 1 is used for connection with the anchoring structure 2.

[0061] Optionally, among the first sealing layer 61 and the second sealing layer 62, the first sealing segment 611 and the second sealing segment 612 are connected by a circumferential suture line 50. Specifically, the first sealing layer 61 is divided into two segments, and is connected and jointed at the connection of the skirt support structure 3 and the stent main body 1. The second sealing layer 62 is also divided into two segments, and is also connected and jointed at the connection of the skirt support structure 3 and the stent main body 1. Because the diameters of the stent main body 1 and the skirt support structure 3 are different, this segmented structure can make the first sealing layer 61 and the second sealing layer 62 have a higher degree of adhesion to the stent main body 1 and the skirt support structure 3 respectively, avoid blood infusion between the first sealing layer 61 and the second sealing layer 62, have better sealing performance, and further reduce the probability of paravalvular leakage.

[0062] In this embodiment, the first sealing layer 61 and the second sealing layer 62 are connected with the stent main body 1 and the skirt support structure 3 by the suture line 50 respectively.Figure 1 The stitching line 50 between the first sealing section 611 and the second sealing section 612 in the first sealing layer 61 is hidden in the middle of the first sealing layer 61, Figure 1 and Figure 2 The stitching line 50 between the first sealing section 611 and the second sealing section 612 in the first sealing layer 61 is hidden in the middle of the first sealing layer 61,

[0063] In the embodiment, the first sealing layer 61 and the second sealing layer 62 are separately arranged. Of course, in some other embodiments, the first sealing layer 61 and the second sealing layer 62 can be integrally arranged, the first sealing layer 61 and the second sealing layer 62 are formed by folding the sealing film 6 to form the first sealing layer 61 and the second sealing layer 62, and the fold between the first sealing layer 61 and the second sealing layer 62 is arranged at the end of the skirt support structure 3. Since the conveying connection structure 5 can be arranged on the skirt support structure 3, a hole can be formed at the fold for connecting the skirt support structure 3 and the conveying connection structure 5. When the first sealing layer 61 and the second sealing layer 62 are integrally arranged, the first sealing layer 61 and the second sealing layer 62 can be formed by 3D cutting.

[0064] Optionally, referring to Figures 4-6 The skirt support structure 3 comprises an outward expanding section 31 and an inward collecting section 32 arranged in the axial direction. One end of the outward expanding section 31 is connected with the stent main body 1, and the other end of the outward expanding section 31 expands towards the outside of the stent main body 1. One end of the inward collecting section 32 is connected with the outward expanding section 31, and the other end of the inward collecting section 32 is collected towards the inside of the stent main body 1. The edges of the inward collecting section 32 are connected in a loop, forming a closed annular frame. This arrangement makes the circumferential direction of the skirt support structure 3 more stable, and the force on the skirt support structure 3 is more uniform. After the paravalvular leakage device is replaced by the transcatheter replacement valve device, the circumferential force on the stent main body 1 is uniform, the stability is strong, the coaxiality of the skirt support structure 3 and the stent main body 1 is ensured, and the circumferential deviation is less likely to occur.

[0065] The outer expansion section 31 of the skirt support structure 3 can facilitate the positioning of the transcatheter replacement valve stent after release, and can cooperate with the anchoring structure 2 to clamp the native valve leaflet 8, so as to anchor the stent body 1 stably; the inner retraction section 32 can first eliminate the sharp end of the outer expansion section 31 extending outward after the stent body 1 is compressed, so that the whole is released more smoothly from the delivery system; further, the inner retraction section 32 and the outer expansion section 31 are reversely bent, and an internal force is formed on the outer expansion section 31; when cooperating with the anchoring structure 2 to clamp the native valve leaflet 8, the inner retraction section 32 can exert a force from the atrial side to the ventricular side on the outer expansion section 31, so as to enhance the clamping force of the anchoring structure 2 and the skirt support structure 3 on the native valve leaflet 8, and make the transcatheter replacement valve device anchor more stably; finally, it can also effectively prevent the problem of myocardial injury caused by the shrinkage of the left atrium 9 after the compensatory disappearance after the surgical treatment. It should be noted here that in the pathology of mitral regurgitation, part of the blood flow of the left ventricle 10 will flow back to the left atrium 9 during the systole of the heart. Since the left atrium 9 receives both the blood flow from the pulmonary vein and the blood flow from the left ventricle 10, the left atrium 9 compensates for hypertrophy. The blood ejected from the left atrium 9 to the left ventricle 10 during diastole increases, and the left ventricle 10 compensates for hypertrophy. After the treatment of mitral valve replacement surgery, since the closure of the mitral valve is restored to normal, the problem of blood reflux disappears, and after a certain period of time, the left ventricle 10 gradually returns to normal volume. At this time, due to the recovery of the left ventricle 10, the heart wall will also shrink, at this time, if the outer expansion section of the skirt support structure 3 is a sharp end extending outward, it is easy to cause the problem of myocardial injury. The inner retraction section 32 in the present application can solve this problem.

[0066] Optionally, the anchoring structure 2 is a closed frame structure; when the stent body 1 is in the compressed state, the anchoring structure 2 at least partially overlaps the stent body 1 in the radial direction, so that the transcatheter replacement valve stent forms a double-layer frame structure when compressed. This arrangement can solve the problem of difficulty in bending the sheath tube 40 during delivery due to the excessive length of the transcatheter replacement valve stent after compression.

[0067] The stent body 1 in the crimped state, because the anchoring structure 2 at least partially overlaps with the stent body 1 in the radial direction, compared with the existing replacement valve stent, the present application can greatly shorten the length of the replacement valve stent after crimping, so that the replacement valve stent occupies a short length of the bending sheath 40 in the delivery system, the replacement valve stent can avoid large angle bending in the narrow space in the delivery process, so that the bending sheath 40 is easier to bend, and the mechanical strength and performance requirements of the bending sheath 40 of the delivery system are reduced. In addition, because the anchoring structure 2 is a closed frame structure arranged around the outer periphery of the stent body 1, compared with the existing multiple independent anchoring rods 211, after the transcatheter replacement valve stent is released, a more stable anchoring force can be provided, the closed frame structure has mutual force, high overall strength, and can provide more stable support force for the stent body 1, effectively preventing the stent body 1 from moving circumferentially.

[0068] Referring to Figure 12 , the delivery system includes a bending sheath 40, the transcatheter replacement valve stent carrying the artificial valve 7 is loaded into the bending sheath 40 after being crimped, the bending sheath 40 passes through the atrial septum 30 from the right atrium into the left atrium 9, at this time, a bending of about 90° is needed, the head end of the bending sheath 40 is in a transverse state when passing through the atrial septum 30, and continues to advance to enter the left ventricle 10, which needs to be bent from transverse to vertical, that is, the head end of the bending sheath 40 and the main body part thereof are bent at about 90°, which is also the area with the largest bending angle in the entire replacement surgery process. However, in the prior art, the axial length of the replacement valve stent after crimping is greater than the axial length in the expanded state, the left atrium 9 is narrow, the bending is difficult, and the loading of the replacement valve stent in the crimped state in the bending sheath 40 makes the bending more difficult and the mechanical strength and performance requirements of the bending sheath 40 higher. In the embodiment, the replacement valve stent is arranged in a double-layer structure, which greatly shortens the length of the replacement valve stent after crimping, so that the replacement valve stent is located at the head end of the bending sheath 40 and avoids the largest bending position of the bending sheath 40, referring to Figure 12 , there is no replacement valve stent in the bending sheath 40 with the largest bending angle, which greatly reduces the bending difficulty, improves the efficiency and success rate of the replacement surgery, and also reduces the mechanical strength and performance requirements of the bending sheath 40, thereby reducing the cost of the bending sheath 40.

[0069] Further, referring to Figure 5 , the stent body 1 has a first end and a second end arranged oppositely, so that Figure 5 , the first end of the stent body 1 is the upper end, which is also the inflow end; and the second end of the stent body 1 is the lower end, which is also the outflow end. Referring to Figure 13 , after the stent body 1 is released, the first end of the stent body 1 is located in the left atrium 9, and the second end of the stent body 1 is located in the left ventricle 10.

[0070] Further, referring to Figures 7-11 , the anchoring structure 2 comprises a plurality of anchoring members 21 which are spaced apart around the outer periphery of the stent body 1, the anchoring members 21 are provided with a fixed end and a free end, the fixed end is connected with the stent body 1, and in the expanded state of the stent body 1, the free end of the anchoring structure 2 expands outward in the radial direction of the stent body 1, and is adapted to provide radial support force for the stent body 1, so as to anchor the stent body 1. As a preferred embodiment, the fixed end is connected with the second end of the stent body 1, that is Figure 1 , the part of the stent body 1 which is not covered by the second sealing layer 62 in the stent body 1. The free end extends towards the first end of the stent body 1, so that when the stent body 1 is in the crimped state, at least one of the stent body 1 and the anchoring structure 2 is completely overlapped in the radial direction with the other. In this way, the length of the radial overlap between the anchoring structure 2 and the stent body 1 can be maximized, and the length of the replacement valve stent after crimping can be shortened to the greatest extent. In the present embodiment, since the first end of the stent body 1 is connected with the skirt structure 3, the total length of the skirt structure 3 and the stent body 1 in the axial direction is greater than the axial length of the anchoring member 21 in the crimped state, that is, the stent body 1 is completely overlapped with the anchoring member 21 in the radial direction in the crimped state.

[0071] The plurality of anchoring members 21 which are spaced apart around the outer periphery of the stent body 1 can provide radial support force around the stent body 1, and ensure the stable anchoring of the stent body 1. As a preferred embodiment, the plurality of anchoring members 21 are uniformly spaced apart around the outer periphery of the stent body 1, so that the circumferential direction of the stent body 1 is uniformly supported, and the radial displacement of the stent body 1 is prevented.

[0072] Further, referring to Figure 10 and Figure 11 , Figure 10 10-2 and Figure 11The structure of the single anchor rod 211 is shown in FIG. 11-2. The anchor 21 is arranged around the outer periphery of the stent body 1, and has at least two connecting portions 212. The anchor 21 is connected to the stent body 1 through the connecting portions 212 to form the fixed end described above. The two adjacent connecting portions 212 are connected through a support portion 213 to form a closed loop structure. When the stent body 1 is in the expanded state, the support portion 213 expands towards the outside of the stent body 1, and provides a radial support force to anchor the stent body 1. The support portion 213 forms the free end described above. When the stent body 1 is in the expanded state, the anchor 21 releases the outer periphery of the stent body 1 and expands outwardly. The anchor 21 can provide a radial anchoring force to the stent body 1 to fix the stent body 1. As a preferred embodiment, a plurality of anchors 21 are arranged end to end on the stent body 1, or a plurality of anchors 21 are uniformly spaced on the stent body 1. When the adjacent anchors 21 are spaced apart, the anchors 21 are all connected to the stent body 1 to form a closed loop frame structure, or can be connected through a reinforcing structure 4 to form a closed loop frame structure, as shown in FIGS. 10 and Figure 11 The reinforcing structure 4 will be described later. The plurality of anchors 21 can provide more balanced anchoring force to the outer periphery of the stent body 1, so that the anterior and posterior cusps of the mitral valve can be uniformly clamped to ensure stable clamping.

[0073] Further, in this embodiment, the anchor 21 includes an anchor rod 211, as shown in FIG. 11-2. Figures 7-11 The two ends of the anchor rod 211 are the connecting portions 212, and the middle portion of the anchor rod 211 is bent to form the support portion 213. The connecting portion 212 of the anchor rod 211 is connected to the second end of the stent body 1. When the stent body 1 is in the expanded state, the support portion 213 of the anchor rod 211 extends towards the first end of the stent body 1.

[0074] Further, the support portion 213 has a bending structure 214. The number of bending structures 214 can be one or more. For example, when the support portion 213 has one bending structure 214, the anchor rod 211 is similar to the letter "n" type. When the support portion 213 has three bending structures 214, the anchor rod 211 is similar to the letter "m" type.

[0075] The middle portion of the anchor rod 211 is provided with the bending structure 214, and the two ends of the anchor rod 211 are connected to the stent body 1. Compared with the single anchor rod 211 scheme in which one end is connected to the stent body 1 and the other end is a free end, the present application has better support force and stability, and can prevent the stent body 1 from being circumferentially offset.

[0076] Specifically, in this embodiment, the middle portion of the anchor rod 211 is provided with the bending structure 214, as shown in FIG. 11-2. Figure 10As shown in FIG. 10-2, the middle of the anchoring rod 211 is bent so that both ends of the anchoring rod 211 are directed towards the second end of the stent main body 1, and the two ends of the anchoring rod 211, i.e. the two connecting portions 212, are connected with the second end of the stent main body 1. When the stent main body 1 is in the expanded state, the bent structure 214 in the middle of the anchoring rod 211 extends towards the first end of the stent main body 1. Of course, the connecting portions 212 are not limited to the two ends of the anchoring rod 211, but can also be other parts close to the two ends.

[0077] Further, the outer contour of the bent structure 214 is a smooth curve.

[0078] The outer contour of the bent structure 214 is a smooth curve, which can prevent the anchoring member 21 from injuring the myocardial tissue 20 or puncturing the native valve leaflet 8. In addition, during the operation, the single anchoring rod 211 will inevitably pull the chordae tendineae during the release process. However, because the present application has a smooth bent structure 214, it is easier to pass through the chordae tendineae, thereby solving the problem of pulling the chordae tendineae.

[0079] Further, the anchoring member 21 has a first connecting portion 2121 and a second connecting portion 2122, with reference to Figure 10 and Figure 11 The bent structure 214 includes a first bent segment 2141 connected with the first connecting portion 2121 and a second bent segment 2142 connected with the second connecting portion 2122, and the first bent segment 2141 and the second bent segment 2142 have a relative torsion angle, so that the anchoring structure 2 forms a spiral closed frame structure.

[0080] The relative torsion angle between the first bent segment 2141 and the second bent segment 2142 of the bent structure 214 makes the first bent segment 2141 and the second bent segment 2142 have a strong interaction force. When the stent main body 1 is released and subjected to external force, the stent main body 1 tends to shift circumferentially. However, because of the interaction force between the first bent segment 2141 and the second bent segment 2142, the first bent segment 2141 and the second bent segment 2142 restrict each other, thereby maintaining the fixed position of the stent main body 1, ensuring the clamping stability between the stent main body 1 and the native annulus, and preventing the stent main body 1 from circumferentially shifting.

[0081] Further, the relative torsion angle between the first bent segment 2141 and the second bent segment 2142 is 45°-135°.

[0082] As a specific embodiment, the relative torsion angle between the first bent segment 2141 and the second bent segment 2142 is 45°.

[0083] Of course, as another specific embodiment, the relative torsion angle between the first bent segment 2141 and the second bent segment 2142 is 135° Of course, as another specific embodiment, the relative torsion angle between the first bent segment 2141 and the second bent segment 2142 is 135°

[0084] As a preferred embodiment, the relative torsion angle between the first bending section 2141 and the second bending section 2142 is 90°.

[0085] When the anchor 21 is an anchor rod 211, the connecting section 212 and the supporting section 213 are integrated, and the anchor rod 211 is bent at the middle part to form the anchor 21. When the relative torsion angle exists between the first bending section 2141 and the second bending section 2142, the force point is at the two ends of the anchor rod 211 because the middle part of the anchor rod 211 is twisted, and the force arm is long, as shown in 11-3 in the description, so only a small bending force is needed to form the anchor 21. Figure 11

[0086] When the stent body 1 is in the expanded state, the skirt structure 3 and the anchor structure 2 cooperate to form a first clamping mechanism, and the clamping mechanism is suitable for clamping the native valve leaflet 8. The anchor structure 2 of the present application can provide radial support and can also clamp the native valve leaflet 8 through the cooperation of the anchor structure 2 and the skirt structure 3 to form the first clamping mechanism, so as to prevent the trans-catheter replacement valve stent from moving and further avoid paravalvular leakage or other complications. In addition, because the skirt structure 3 is located on the atrial side of the native valve leaflet 8, it can clamp the root of the native valve leaflet 8, the clamping is more stable, and the trans-catheter replacement valve stent is less likely to move in the radial and axial directions of the stent body 1.

[0087] Specifically, the supporting section 213 cooperates with the outward expanding section 31 of the skirt structure 3 to clamp the native valve leaflet 8 when the ventricle contracts, thereby preventing the trans-catheter replacement valve stent from moving and preventing paravalvular leakage.

[0088] From the perspective of Figure 5 , the skirt structure 3 expands towards the outside of the stent body 1, the anchor rod 211 is also located on the outside of the stent body 1, and the skirt structure 3 and the supporting section 213 of the anchor rod 211 form a first clamping mechanism on the outer periphery of the stent body 1, as previously described with reference to Figure 13 , after the trans-catheter replacement valve stent is released, the skirt structure 3 is located in the left atrium 9, i.e., on the upper part of the native valve leaflet 8, and the anchor rod 211 is located in the left ventricle 10, i.e., on the lower part of the native valve leaflet 8, and the skirt structure 3 and the anchor rod 211 clamp the native valve leaflet 8 therebetween.

[0089] With reference to Figure 13 , the outward expanding section 31 can be bent to fit the myocardial tissue 20 or the atrial septum 30, thereby improving the sealing effect and preventing paravalvular leakage. The outward expanding section 31 and the inward contracting section 32, or the outward expanding section 31 and the stent body 1, have a mesh opening 33 therebetween.

[0090] As a preferred embodiment, the supporting section 213 of the anchor rod 211 extends into the mesh opening 33. ​

[0091] The skirt support structure 3 is a ring-shaped frame structure, and the anchor rod 211 surrounds the stent body 1, so that multiple clamping points are formed between the skirt support structure 3 and the anchor rod 211 around the stent body 1. Referring to Figures 9-11 In the embodiment, 12 anchor rods 211 are provided, and specifically, the support portions 213 of the anchor rods 211 extend to the grid openings 33 of the skirt support structure 3. The grid openings 33 of the skirt support structure 3 can be clamped by at least two skirt support rods to the native valve leaflet 8. Compared with the scheme in which the anchor rod 211 is matched with a single skirt support rod of the skirt support structure 3 to clamp the native valve leaflet 8, the support portions 213 of the anchor rods 211 extend to the grid openings 33 of the skirt support structure 3, and at least two skirt support rods are matched with the anchor rod 211 to clamp the native valve leaflet 8, so that the clamping area is large and the clamping is more stable.

[0092] After the stent body 1 is deployed, at least part of the first bending section 2141 is attached to the outer wall of the stent body 1 to form a second clamping mechanism for clamping the native valve leaflet 8. The second bending section 2142 can provide pressure for clamping due to the relative torsion angle between the first bending section 2141 and the second bending section 2142, so that the second clamping mechanism clamps more tightly. The 12 anchor members 21 around the stent body 1 form a cylindrical clamping surface with the stent body 1, the clamping area is increased, and the native valve leaflet 8 is clamped together with the first clamping mechanism, so that the clamping is more stable, and the sealing effect is also better.

[0093] Further, the adjacent two anchor members 21 are connected with the reinforcing structure 4, which can further improve the strength and stability of the anchor member 21, further prevent the stent body 1 from being deviated in the circumferential direction, ensure the transverse stability of the anchor structure 2, Figure 8 which can also be said as the horizontal stability, ensure the clamping stability between the stent body 1 and the native valve annulus, and avoid the paravalvular leakage caused by the displacement of the stent body 1.

[0094] Further, the reinforcing structure 4 includes a reinforcing rod 41, and the reinforcing rod 41 is one or a combination of V-shaped, U-shaped, and W-shaped. In the embodiment, the two ends of the reinforcing rod 41 are respectively connected with the adjacent two connecting portions 212. Referring to Figure 10 In the embodiment, the reinforcing rod 41 is V-shaped. The reinforcing rod 41 is attached to the stent body 1 and is connected by suturing with the suturing line 50, which is omitted in the drawings. The V-shaped, U-shaped, and W-shaped refer to the shape of the reinforcing rod 41, and since the reinforcing rod 41 is connected with the stent body 1 by suturing, the arrangement direction of the reinforcing rod 41 is not limited. Taking the V-shaped reinforcing rod 41 as an example, in the embodiment, the tip of the V-shaped reinforcing rod 41 faces the second end of the stent body 1, and Figure 7The tip of the V-shaped reinforcing rod 41 is downwardly directed. Of course, in some other embodiments, the tip of the V-shaped reinforcing rod 41 can be upwardly directed. In addition, the connecting position of the reinforcing rod 41 is not limited to the fixed end of the anchoring rod 211, but can be located at the middle of the anchoring rod 211. In this case, in order not to affect the unfolding of the anchoring rod 211, the reinforcing rod 41 can not be connected with the stent main body 1, and the reinforcing rod 41 connects the plurality of anchoring members 21 into a closed frame, further improving the circumferential stability of the anchoring structure 2.

[0095] Optionally, the second end of the stent main body 1 and / or the skirt support structure 3 is provided with a delivery connection structure 5. The delivery connection structure 5 includes a plurality of connecting rods 51 arranged around the stent main body 1. The first end of the connecting rod 51 is connected with the second end of the stent main body 1 and / or the skirt support structure 3. The second end of the connecting rod 51 extends away from the first end of the connecting rod 51 along the axial direction of the stent main body 1, and a hanging part 52 is arranged at the end. The hanging part 52 is suitable for being connected with a delivery system.

[0096] Specifically, in the present embodiment, referring to Figure 13 , the first end of the connecting rod 51 is connected with the skirt support structure 3. The second end of the connecting rod 51 extends away from the first end of the connecting rod 51 along the axial direction of the stent main body 1, and a hanging part 52 is arranged at the end. The hanging part 52 is suitable for being connected with a delivery system. The delivery connection structure 5 is arranged on the skirt support structure 3, and the applicable access is through the atrial septum 30. Of course, in some other embodiments, the delivery connection structure 5 is arranged on the second end of the stent main body 1, and the applicable access is through the heart apex.

[0097] Of course, in some other embodiments, the delivery connection structure 5 can be arranged at both ends, that is, the delivery connection structure 5 is arranged on the skirt support structure 3 and the second end of the stent main body 1. When the structure is released, it can be released from both ends.

[0098] The hanging part 52 protrudes from the connecting rod 51, which is beneficial to provide a fulcrum for connection with the delivery system. At the same time, it can prevent impact force from being generated during the release process of the skirt support structure 3, causing the anchoring member 21 to be displaced or even causing damage to the heart. In the present embodiment, six connecting rods 51 are arranged around the stent main body 1 at uniform intervals, and the hanging part 52 is a cross rod arranged perpendicular to the connecting rod 51. Of course, the hanging part 52 can also be a circular ring or other structure protruding from the connecting rod 51. Of course, in some other embodiments, the connecting rod 51 can also be arranged in 12 or other quantities.

[0099] The arrangement of the delivery connection structure 5 on the second end of the stent main body 1 and / or the skirt support structure 3 makes the transcatheter replacement of the valve stent meet the two access methods of through the atrial septum 30 and through the heart apex, which is convenient for selecting the appropriate access method according to the actual situation of the patient, thereby improving the difficulty of transcatheter replacement of the valve surgery.

[0100] Embodiment 2

[0101] The transcatheter replacement valve device comprises the transcatheter replacement valve stent of any one of the above technical solutions.

[0102] Optionally, the inner side of the stent body 1 is provided with an artificial valve 7, and the artificial valve 7 is sutured to the first sealing layer 61; the artificial valve 7 is provided with two pieces, which is suitable for replacing the mitral valve of the patient; or the artificial valve 7 is provided with three pieces, which is suitable for replacing the aortic valve of the patient; or the artificial valve 7 is provided with four pieces, which is suitable for the heart valve of a special patient.

[0103] The artificial valve 7 is directly sutured to the first sealing layer 61, and the first sealing layer 61 is directly sutured to the stent body 1, so that a larger suture window or a leaflet suture ear does not need to be arranged on the stent body 1, the width of the support rod has higher consistency, and the mechanical properties are more uniform; at the same time, since the leaflet suture window or the leaflet suture ear is cancelled, the width of the support rod is reduced, so that the radial size of the stent body 1 is smaller after being pressed, thereby the smaller diameter delivery system can be used for delivery in the operation process, and the passability in the blood vessel is better.

[0104] A percutaneous catheter is a catheter inserted through the skin with a needle. All catheters are hollow tubes that allow fluid to enter the body or allow excess body fluid to be drained out of the body through the catheter into an appropriate disposal container.

[0105] The method for using the transcatheter replacement valve device suitable for the mitral valve comprises the following steps.

[0106] Step S1: puncture the femoral vein of the patient on one side, send the guide wire and the puncture sheath into the right atrium, puncture the interatrial septum 30, pass through the mitral valve and enter the left ventricle 10;

[0107] Step S2: load the transcatheter replacement valve device into the corresponding delivery system, and send the delivery system into the left ventricle 10 along the guide wire track;

[0108] Step S3: adjust the direction of the delivery system through the mark on the delivery system, release the anchor rod 211 first, then release the stent body 1 and the skirt support structure 3, so that the skirt support structure 3 is supported at the bottom of the left atrium 9, and finally release the delivery connection structure 5;

[0109] Step S4: withdraw the delivery system for interventional mitral valve to the right atrium, send it into the interatrial septum 30 occluder, occlude the interatrial septum 30, and complete the operation.

[0110] In the above steps, the positioning, fixing and releasing steps are completed by one-way withdrawal of the sheath, which effectively reduces the radial size of the delivery system and reduces the compression and damage of the head end of the delivery system to the interventricular septum.

[0111] Surgical procedure: puncture femoral vein through atrial septum 30 approach, puncture interventricular septum, establish left ventricular 10 to right ventricular guide wire track, send in interventional catheter replacement valve device along guide wire, release anchor rod 211, retreat sheath, release replacement valve. Block atrial septum 30, end of operation.

[0112] Obviously, the above embodiments are only examples for clearly illustrating, but not limitation to the embodiments. Other different forms of changes or variations can be made on the basis of the above description for those skilled in the art. Here, all the embodiments need not and can not be exhausted. The obvious changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. A transcatheter valve replacement stent, characterized in that, include: The support body (1) is a cylindrical frame structure that can be radially compressed and unfolded, and has a pressed state and an unfolded state; Anchoring structure (2) is a frame structure arranged around the outer periphery of the support body (1); when the support body (1) is in the unfolded state, the anchoring structure (2) extends outward toward the support body (1) to anchor the support body (1); the anchoring structure (2) includes a plurality of anchoring members (21) spaced apart around the outer periphery of the support body (1), the anchoring member (21) has at least two connecting parts (212), and two adjacent connecting parts (212) are connected by a support part (213) to form a closed loop structure; the support part (213) has a bending structure (214), the outer contour of the bending structure (214) is a smooth curve; A skirt structure (3) is a ring frame structure. The skirt structure (3) is located at the first end of the support body (1). The diameter of the skirt structure (3) is not less than the diameter of the support body (1). A sealing membrane (6) is a circumferentially closed cylindrical structure. The sealing membrane (6) includes a first sealing section (611) and a second sealing section (612) that are arranged axially and connected to each other. The first sealing section (611) is tightly attached to all of the skirt structure (3), and the second sealing section (612) is tightly attached to all of the support body (1). The sealing membrane is located on the inner and / or outer sides of the skirt structure (3) and the support body (1). The anchor (21) has a first connecting part (2121) and a second connecting part (2122). The bending structure (214) includes a first bending segment (2141) connected to the first connecting part (2121) and a second bending segment (2142) connected to the second connecting part (2122). The first bending segment (2141) and the second bending segment (2142) have a relative torsion angle, so that the anchor (2) forms a spiral closed frame structure.

2. The transcatheter valve replacement stent according to claim 1, characterized in that, The sealing film (6) includes a first sealing layer (61) and a second sealing layer (62). The first sealing layer (61) is disposed on the inner side of the support body (1) and the skirt structure (3), and the second sealing layer (62) is disposed on the outer side of the support body (1) and the skirt structure (3).

3. The transcatheter valve replacement stent according to claim 2, characterized in that, The first end of the first sealing layer (61) and the second sealing layer (62) extends to the end of the skirt structure (3), and the second end of the first sealing layer (61) extends to the second end of the support body (1).

4. The transcatheter valve replacement stent according to claim 1, characterized in that, The skirt structure (3) includes an outwardly expanding section (31) and an inwardly contracting section (32) arranged along the axial direction. One end of the outwardly expanding section (31) is connected to the support body (1), and the other end of the outwardly expanding section (31) extends outward toward the outside of the support body (1). One end of the inwardly contracting section (32) is connected to the outwardly expanding section (31), and the other end converges inward toward the inside of the support body (1).

5. The transcatheter valve replacement stent according to claim 1, characterized in that, The main body of the support (1) is a diamond-shaped grid structure composed of several support rods, and the sealing film (6) is connected to the support rods.

6. The transcatheter valve replacement stent according to claim 1, characterized in that, The anchoring structure (2) is a closed frame structure; when the stent body (1) is in the gripping state, the anchoring structure (2) overlaps at least partially with the stent body (1) in the radial direction, so that the transcatheter valve replacement stent forms a double-layer frame structure when gripped.

7. The transcatheter valve replacement stent according to claim 6, characterized in that, The anchor (21) has a fixed end and a free end. The fixed end is connected to the support body (1). When the support body (1) is in the unfolded state, the free end extends outward along the radial direction of the support body (1) to provide radial anchoring force to the support body (1).

8. The transcatheter valve replacement stent according to claim 7, characterized in that, The anchor (21) is connected to the support body (1) via the connecting part (212) to form the fixed end; when the support body (1) is in the unfolded state, the support part (213) extends toward the outside of the support body (1) to anchor the support body (1), and the support part (213) forms the free end.

9. The transcatheter valve replacement stent according to claim 8, characterized in that, The relative torsion angle between the first bending segment (2141) and the second bending segment (2142) is 45° to 135°.

10. The transcatheter valve replacement stent according to claim 9, characterized in that, The relative torsion angle between the first bending segment (2141) and the second bending segment (2142) is 90°.

11. The transcatheter valve replacement stent according to any one of claims 7-10, characterized in that, The fixed end is connected to the second end of the support body (1), and the free end extends toward the first end of the support body (1), so that when the support body (1) is in a gripping state, at least one of the support body (1) and the anchoring structure (2) completely overlaps the other in the radial direction.

12. The transcatheter valve replacement stent according to claim 7, characterized in that, The anchoring element (21) includes an anchor rod (211), the two ends of which are the fixed ends, and the middle part of the anchor rod (211) is bent to form the free end.

13. The transcatheter valve replacement stent according to claim 12, characterized in that, A reinforcing structure (4) connects two adjacent anchors (21).

14. The transcatheter valve replacement stent according to claim 13, characterized in that, The reinforcing structure (4) includes a reinforcing rod (41), which is a combination of one or more of the V-shaped, U-shaped, and W-shaped types. The two ends of the reinforcing rod (41) are respectively connected to two adjacent anchors (21).

15. The transcatheter valve replacement stent according to claim 14, characterized in that, The second end of the support body (1) and / or the skirt structure (3) is provided with a conveying connection structure (5), the conveying connection structure (5) includes a plurality of connecting rods (51) arranged around the support body (1), the first end of the connecting rod (51) is connected to the second end of the support body (1) and / or the skirt structure (3), the second end of the connecting rod (51) extends away from its first end along the axial direction of the support body (1), and a hook part (52) is provided at the end, the hook part (52) is adapted to be connected to the conveying system.

16. A transcatheter valve replacement device, characterized in that, Includes the transcatheter valve replacement stent according to any one of claims 1-15.

17. The transcatheter valve replacement device according to claim 16, characterized in that, The stent body (1) has an artificial valve (7) on its inner side, and the artificial valve (7) is sutured to the sealing membrane (6); the artificial valve (7) has two pieces, which is suitable for replacing the mitral valve of the patient; or, the artificial valve (7) has three pieces, which is suitable for replacing the aortic valve of the patient; or, the artificial valve (7) has four pieces, which is suitable for heart valves of special patients.

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