Disclosure of Invention
The present invention is directed to solving the deficiencies of the prior art by providing a dual disc atrioventricular valve replacement device which aims to solve at least one of the above-mentioned technical problems to a certain extent.
In order to achieve the above purpose, the present invention provides the following technical solutions:
a double-disc-shaped atrioventricular valve replacement device comprises a hard straight cylinder frame, a lower disc part, an elastic anchoring frame and artificial valve blades. The hard straight cylinder frame is provided with a cavity channel penetrating through two ends of the hard straight cylinder frame, one end of the hard straight cylinder frame extends out of the lower disc part, and the lower disc part is flared and extends outwards along the radial direction of the hard straight cylinder frame; the elastic anchoring frame comprises a column part and a ring part, wherein the column part is sleeved on the outer side of the rigid straight cylinder frame, the inner edge of the ring part is connected with the column part, one end of the column part, which is far away from the ring part, is connected with the rigid straight cylinder frame, one end of the ring part, which is close to the lower disc part, is provided with an upper disc surface encircling the periphery of the rigid straight cylinder frame, and the artificial valve leaf is fixed in a cavity channel and/or the lower disc part of the rigid straight cylinder frame.
The elastic anchoring frame in the double-disc-shaped atrioventricular valve replacement device is arranged on the outer side of the hard straight cylinder frame in a more flexible manner, so that the distance between the elastic anchoring frame and the lower disc part is easy to control during processing and manufacturing. Moreover, the structural design of the double-disc atrioventricular valve replacement device is beneficial to shortening the distance between the elastic anchoring frame and the lower disc part, preventing the adjacent anatomical structure at the setting position from being influenced, and simultaneously controlling the rigid straight cylinder frame to be in a proper length so as to be convenient for better suturing the artificial valve leaflet.
The lower disc portion is flared so that it more easily retains the valve from the ventricular side when released. The artificial valve is trefoil, is a biological valve or a polymer valve, and is sewed on the straight cylinder part and the lower disc part of the hard straight cylinder frame. Because the lower disc part is horn-shaped, the artificial valve leaflet suture is horn-shaped extending from the straight cylinder part to the abduction, the suture height of the valve leaflet can be improved, and the oblique suspension bridge effect is achieved, so that the vertical tensile resistance of the valve is larger, the durability of the valve is improved, and meanwhile, the design increases the opening area of the valve orifice of the artificial valve leaflet, and the artificial valve leaflet suture is more suitable for the occurrence of a narrow valve orifice of the mitral valve.
In some embodiments, the location of the connection of the edge of the artificial leaflet to the stiff straight cylinder frame is on the side of the elastic anchoring frame remote from the lower disc portion.
Through making the edge of artifical lamella and the hookup location of hard straight section of thick bamboo frame be located the one side that the lower wall portion was kept away from to the elasticity anchor frame, can avoid the waist position of hard straight section of thick bamboo frame to receive the excessive deformation of artifical lamella that leads to when radial compression to guarantee the involution of artifical lamella, and then keep hemodynamic stability.
In some embodiments, the rigid straight cylinder frame, the lower disc portion and the elastic anchoring frame can be radially contracted, and the artificial valve leaflet can be synchronously contracted along with the rigid straight cylinder frame.
After the hard straight cylinder frame, the lower disc part, the elastic anchoring frame and the artificial valve are contracted, the whole circumferential size of the double-disc-shaped atrioventricular valve replacement device is reduced, so that the double-disc-shaped atrioventricular valve replacement device is conveniently loaded into the catheter conveying device.
In some embodiments, the elastic anchoring frame is woven from memory alloy wires with a biocompatible membrane attached to the elastic anchoring frame.
The braided elastic anchoring frame has excellent elastic deformation capability, can better adapt to a special valve ring structure, prevents the valve periphery from leaking, and can adapt to a special planing structure, thereby avoiding the influence of excessive radial force on the contraction and the relaxation of the valve ring.
In some embodiments, the rigid straight tube holder is made from a metal tube having a memory alloy effect by laser cutting.
The hard straight cylinder frame can be easily obtained by a laser cutting mode, and the obtained hard straight cylinder frame has higher qualification rate.
In some embodiments, the upper disc surface is a conical surface, and the upper disc surface is gradually far away from the lower disc portion from the inner side of the upper disc surface to the outer side of the upper disc surface.
The conical upper disc surface can be well attached to an annular structure and fixed on the atrial side of a mitral valve orifice, so that the valve replacement device is prevented from shifting and falling off to the ventricular side, stable anchoring is provided, and paravalvular leakage is further prevented.
In some embodiments, the cone angle of the upper disc surface is 125-165 degrees, when the cone angle of the upper disc surface is within the range, the upper disc surface can be further ensured to be attached to the annular structure, stable anchoring is provided, and meanwhile, peripheral leakage of the valve is further prevented.
In some embodiments, the end of the rigid straight cylinder frame far away from the lower disc part is provided with a plurality of connecting parts, the connecting parts are distributed at intervals along the circumference of the rigid straight cylinder frame, and the connecting parts are provided with through holes.
The connecting part can realize the stable cooperation of the double-disc-shaped atrioventricular valve replacement device and the conveying device, and is convenient for conveying operation.
In some embodiments, the diameter of the lower disc portion gradually increases from one end of the lower disc portion adjacent to the rigid straight barrel to the other end of the lower disc portion, thereby capturing the orifice of the ventricular surface, resulting in a more secure fixation of the dual disc atrioventricular valve replacement device.
In some embodiments, a plurality of limiting blocks are arranged at one end of the lower disc part far away from the hard straight cylinder frame, and limiting holes are defined between the limiting blocks and the lower disc part when the double-disc-shaped atrioventricular valve replacement device is in a contracted state.
When the double-disc-shaped atrioventricular valve replacement device is in a contracted state, a limiting hole defined between the limiting block and the lower disc part can be used for being connected with the conveying device, so that the double-disc-shaped atrioventricular valve replacement device and the conveying device are ensured to be stably fixed.
In some embodiments, the artificial valve leaflet is fixed in the cavity of the rigid straight cylinder frame in a sewing way, and the mounting way of the artificial valve leaflet is simpler, thereby being beneficial to reducing the production cost.
In some embodiments, the ring body part has a single-layer structure, and the column body part comprises a first column body and/or a second column body, wherein the first column body is positioned between the ring body part and the lower disc part, and the second column body and the first column body are respectively positioned at two sides of the ring body part; one end of the first column body and the second column body, which are far away from the ring body part, are connected with the hard straight cylinder frame, and one end of the first column body and the second column body, which is close to the ring body part, is a free end and is connected with the inner edge of the ring body part.
By connecting the inner edge of the ring body with the free ends of the first and/or second cylinders, the ring body is provided with a better deformability for adapting to the heart tissue.
In some embodiments, the ring body portion includes a first ring body and a second ring body, the lower surface of the first ring body forms an upper disk surface, the second ring body is located at one side of the first ring body away from the lower disk portion, and the outer edge of the second ring body is connected with the outer edge of the first ring body; the column body part comprises a first column body and a second column body, the first column body is positioned between the first ring body and the lower disc part, one end of the first column body is connected with the inner edge of the first ring body, and the other end of the first column body is connected with the hard straight column frame; the second column body and the first column body are respectively positioned at two sides of the ring body part, one end of the second column body is connected with the inner edge of the second ring body, and the other end of the second column body is connected with the hard straight column frame.
The sealing effect between the elastic anchoring frame and the valve annulus can be further improved by arranging the ring body part into a double-layer structure, so that the leakage of the valve periphery is prevented. And moreover, the first column body and the second column body are utilized to realize the installation of the elastic anchoring frame, so that the installation difficulty of the elastic anchoring frame is reduced. Meanwhile, the double-layer bracket increases the radial supporting force of the bracket, can expand the narrow mitral valve orifice, and increases the orifice opening area of the artificial valve.
The implantation mode of the double-disc atrioventricular valve replacement device can adopt a transfemoral vein-atrioventricular septum mode or a transapical mode. Firstly, loading a double-disc-shaped atrioventricular valve replacement device on a conveying device, entering a left ventricle, retracting the conveying device, releasing the ventricular side of the double-disc-shaped atrioventricular valve replacement device and the lower disc part of a rigid straight cylinder frame, moving the whole conveying system to enable the lower disc part to be close to the ventricular side of a mitral valve orifice and clamp the orifice, continuously releasing the double-disc-shaped atrioventricular valve replacement device, opening an elastic anchoring frame on the atrial side, enabling the double-disc-shaped atrioventricular valve replacement device to be fixed at the mitral valve orifice, then performing clinical imaging and hemodynamic evaluation, and completely releasing the double-disc-shaped atrioventricular valve replacement device if a satisfactory effect is achieved; if satisfactory results are not achieved, the dual disc atrioventricular valve replacement device can be fully retrieved to the delivery device and withdrawn.
Compared with the prior art, the double-disc-shaped atrioventricular valve replacement device provided by the invention has the advantages that the coaxiality of the conveying device and the mitral valve of a human body is not required to be considered, an accurate bending system is not required to be adopted for the conveying device, the operation is more convenient, and the processing of the conveying device is simpler. The double-disc-shaped atrioventricular valve replacement device can be recycled after being released, so that the placement position of the double-disc-shaped atrioventricular valve replacement device can be conveniently adjusted secondarily in vivo.
The double-disc-shaped atrioventricular valve replacement device provided by the invention has the following beneficial effects:
1. the expanded lower disc part of the double-disc atrioventricular valve replacement device and the outward inclined high-adjustment bridge valve leaflet suture mode can increase the long-term durability of the valve, increase the area of the valve orifice, and are more suitable for a narrow mitral valve orifice;
2. the hard straight cylinder frame and the elastic anchoring frame are radially supported in double layers, so that a narrow mitral valve orifice can be expanded, and the narrow mitral valve orifice is more suitable for a narrow mitral valve;
3. the double-disc atrioventricular valve replacement device adopts the structural design of double discs and one waist, has the anchoring principle and technical operation similar to those of the prior heart-shaped plugging device, is reliable in anchoring and simple in operation, and has low requirements on processing and manufacturing of a conveying device.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, based on the examples herein, which are within the scope of the invention as defined by the claims, will be within the scope of the invention as defined by the claims.
Example 1
Referring to fig. 1-3, the present embodiment provides a dual disc atrioventricular valve replacement device comprising a rigid straight cylinder frame 1, a lower disc portion 2, a resilient anchor frame 3 and artificial leaflets 4. The hard straight cylinder frame 1 is provided with a cavity channel penetrating through the upper end and the lower end of the hard straight cylinder frame, a film for reducing perivalvular leakage is covered outside the cavity channel, one end of the hard straight cylinder frame 1 extends out of the lower disc part 2, and the lower disc part 2 is flared and extends outwards along the radial direction of the hard straight cylinder frame 1; the elastic anchoring frame 3 comprises a column part 32 and a ring part 31, the column part 32 is sleeved on the outer side of the rigid straight cylinder frame 1, the inner edge of the ring part 31 is connected with the column part 32, one end of the column part 32 far away from the ring part 31 is connected with the rigid straight cylinder frame 1, and one end of the ring part 31 close to the lower disc part 2 is provided with an upper disc surface surrounding the periphery of the rigid straight cylinder frame 1; the artificial valve leaf 4 is fixed in the cavity channel of the hard straight cylinder frame 1 and/or the lower disc part 2.
The artificial leaflet 4 in this embodiment forms a valve structure that controls the unidirectional flow of blood, which is disposed inside the elastic anchoring frame 3, fixed in place at the native valve of the human body by the upper and lower disc portions 2 of the elastic anchoring frame 3. When the double disc atrioventricular valve replacement device is delivered to a target site, the elastic anchoring frame 3 and the lower disc portion 2 are held against the atrium and ventricle wall by the radial support force of the disc portion, while the rigid straight cylinder frame 1 is held against the annulus position by the radial support force.
The elastic anchoring frame 3 in the present embodiment is installed on the outer side of the rigid straight cylinder frame 1 in a more flexible manner so that the distance between the elastic anchoring frame 3 and the lower disc portion 2 is easily controlled at the time of manufacturing. Moreover, the structural design of the double disc atrioventricular valve replacement device helps to shorten the distance between the elastic anchoring frame 3 and the lower disc portion 2, prevent the influence on the adjacent anatomical structure at the setting position, and simultaneously control the rigid straight cylinder frame 1 to a proper length so as to facilitate better suturing of the artificial valve leaflet 4.
In this embodiment, the connection location of the edge of the artificial leaflet 4 with the rigid straight cylinder frame 1 is located at the side of the elastic anchoring frame 3 remote from the lower disc portion 2, said artificial leaflet 4 not being shown in fig. 1. The suture position of the artificial valve leaflet 4 and the hard straight cylinder frame 1 is positioned above the elastic anchoring frame 3, so that the excessive deformation of the artificial valve leaflet 4 caused by radial compression of the waist position of the hard straight cylinder frame 1 can be avoided, the involution of the artificial valve leaflet 4 is ensured, and the hemodynamic stability is further maintained. In addition, the artificial leaflet 4 may have a longer suture length, thereby avoiding affecting the hemodynamic function of the artificial leaflet 4, preventing premature decay of the artificial leaflet 4.
In this embodiment, the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 can be radially contracted, and the artificial valve leaflet 4 can be synchronously contracted along with the rigid straight cylinder frame 1, and the fully contracted double-disc-shaped atrioventricular valve replacement device is shown in fig. 14. The double-disc-shaped atrioventricular valve replacement device provided by the embodiment can be conveyed to a native valve position of a human body through a conveying device after being contracted in the radial direction so as to replace the native mitral valve of the human body to work. Three-or multi-leaflet prosthetic valve 4 is mounted within the chamber of the self-expanding rigid straight cylinder frame 1, and prosthetic valve 4 can be contracted simultaneously with rigid straight cylinder frame 1 to reduce its circumferential dimension for loading into a catheter delivery device.
The elastic anchoring frame 3 is formed by weaving memory alloy wires, and the biocompatible film 6 is attached to the elastic anchoring frame 3. As shown in fig. 1, the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 all have the structural characteristics of hollowed meshes, and the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 can be easily compressed by the structure. The woven elastic anchoring frame 3 has excellent elastic deformation capability, can better adapt to a special valve ring structure, prevents the valve periphery from leaking, and can adapt to a special planing structure, thereby avoiding the influence of excessive radial force on the contraction and the relaxation of the valve ring.
In this embodiment, the rigid straight cylinder frame 1 is hollow and cylindrical, the rigid straight cylinder frame 1 is made of a metal pipe with a memory alloy effect by laser cutting, the rigid straight cylinder frame 1 has stronger deformation resistance than the elastic anchor frame 3, and the biocompatible film 6 is attached to the rigid straight cylinder frame 1 and the lower disc part 2. In the process of conveying the double-disc-shaped atrioventricular valve replacement device into a human body, the cylindrical hard straight cylinder frame 1 can be better matched with a D-shaped valve ring, and the difficulty of operation is reduced.
In this embodiment, the upper disc surface is a conical surface with a cone angle of 130 degrees, and gradually moves away from the lower disc portion 2 from the inner side of the upper disc surface to the outer side of the upper disc surface. The conical upper disc surface can be well attached to the annular structure, stable anchoring is provided, and meanwhile, perivalvular leakage is further prevented. In order to realize stable cooperation of the double-disc-shaped atrioventricular valve replacement device and the conveying device, one end of the hard straight cylinder frame 1, which is far away from the lower disc part 2, is provided with a plurality of connecting parts 5, the connecting parts 5 are distributed at intervals along the circumferential direction of the hard straight cylinder frame 1, and the connecting parts 5 are provided with through holes 51.
The ring body 31 in this embodiment includes a first ring body 311 and a second ring body 312, which are of a double-layer structure, wherein the lower surface of the first ring body 311 forms an upper disk surface, the second ring body 312 is located at one side of the first ring body 311 away from the lower disk portion 2, and the outer edge of the second ring body 312 is connected with the outer edge of the first ring body 311. The column body part 32 comprises a first column body 321 and a second column body 322, the first column body 321 is positioned between the first ring body 311 and the lower disc part 2, one end of the first column body 321 is connected with the inner edge of the first ring body 311, and the other end of the first column body 321 is connected with the hard straight cylinder frame 1; the second post 322 and the first post 321 are respectively located at two sides of the ring body 31, one end of the second post 322 is connected with the inner edge of the second ring body 312, and the other end of the second post 322 is connected with the rigid straight cylinder frame 1.
In a specific implementation, the column portion 32 and the rigid straight cylinder frame 1 may be connected by a mechanical connection manner such as embedding, riveting, sleeve interference press-holding, etc.
In this embodiment, from one end of the lower disc portion 2 adjacent to the rigid straight barrel holder 1 to the other end of the lower disc portion 2, the diameter of the lower disc portion 2 gradually increases, and the outer surface of the lower disc portion 2 is a curved surface adapted to the physiological structure of the ventricle. As shown in fig. 2, the diameter of the upper end of the lower plate 2 is the same as that of the rigid straight cylinder frame 1, the diameter of the lower end of the lower plate 2 is larger than that of the upper end, and the lower plate 2 is integrally connected with the rigid straight cylinder frame 1.
Example 2
Referring to fig. 4 and 5, the present embodiment provides another dual disc atrioventricular valve replacement device comprising a rigid straight cylinder frame 1, a lower disc portion 2, a resilient anchor frame 3 and a prosthetic leaflet 4. The hard straight cylinder frame 1 is provided with a cavity which penetrates through the upper end and the lower end of the hard straight cylinder frame 1, one end of the hard straight cylinder frame 1 extends out of the lower disc part 2, and the lower disc part 2 is flared outwards along the radial direction of the hard straight cylinder frame 1; the elastic anchoring frame 3 comprises a column part 32 and a ring part 31, the column part 32 is sleeved on the outer side of the rigid straight cylinder frame 1, the inner edge of the ring part 31 is connected with the column part 32, one end of the column part 32 far away from the ring part 31 is connected with the rigid straight cylinder frame 1, and one end of the ring part 31 close to the lower disc part 2 is provided with an upper disc surface surrounding the periphery of the rigid straight cylinder frame 1; the artificial valve blade 4 is arranged in the cavity and connected with the hard straight cylinder frame 1, the connection position of the edge of the artificial valve blade 4 and the hard straight cylinder frame 1 is positioned at one side of the elastic anchoring frame 3 away from the lower disc part 2, and the artificial valve blade 4 is not shown in fig. 4.
In this embodiment, the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 can be radially contracted, and the artificial valve leaflet 4 can be synchronously contracted along with the rigid straight cylinder frame 1. The elastic anchoring frame 3 is formed by weaving memory alloy wires, the hard straight cylinder frame 1 is hollow cylindrical, the hard straight cylinder frame 1 is made of metal pipes with a memory alloy effect in a laser cutting mode, the deformation resistance of the hard straight cylinder frame 1 is stronger than that of the elastic anchoring frame 3, and the hard straight cylinder frame 1 and the elastic anchoring frame 3 are respectively attached with a biocompatible film 6. As shown in fig. 4, the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 all have the structural characteristics of hollowed meshes, and the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 can be easily compressed by the structure.
In this embodiment, the upper disc surface is a conical surface with a cone angle of 160 degrees, and gradually moves away from the lower disc portion 2 from the inner side of the upper disc surface to the outer side of the upper disc surface. The conical upper disc surface can be well attached to the annular structure, stable anchoring is provided, and meanwhile, perivalvular leakage is further prevented. In order to realize stable cooperation of the double-disc-shaped atrioventricular valve replacement device and the conveying device, one end of the hard straight cylinder frame 1, which is far away from the lower disc part 2, is provided with a plurality of connecting parts 5, the connecting parts 5 are distributed at intervals along the circumferential direction of the hard straight cylinder frame 1, and the connecting parts 5 are provided with through holes 51.
The ring body 31 in this embodiment includes a first ring body 311 and a second ring body 312, which are of a double-layer structure, wherein the lower surface of the first ring body 311 forms an upper disk surface, the second ring body 312 is located at one side of the first ring body 311 away from the lower disk portion 2, and the outer edge of the second ring body 312 is connected with the outer edge of the first ring body 311. The column body part 32 comprises a first column body 321 and a second column body 322, the first column body 321 is positioned between the first ring body 311 and the lower disc part 2, one end of the first column body 321 is connected with the inner edge of the first ring body 311, and the other end of the first column body 321 is connected with the hard straight cylinder frame 1; the second post 322 and the first post 321 are respectively located at two sides of the ring body 31, one end of the second post 322 is connected with the inner edge of the second ring body 312, and the other end of the second post 322 is connected with the rigid straight cylinder frame 1.
As shown in fig. 5, the diameter of the lower end of the first post 321 is smaller than that of the upper end thereof, and the upper end of the first post 321 is smoothly transited to the first ring body 311.
In this embodiment, from one end of the lower disc portion 2 adjacent to the rigid straight barrel holder 1 to the other end of the lower disc portion 2, the diameter of the lower disc portion 2 gradually increases, and the outer surface of the lower disc portion 2 is a curved surface adapted to the physiological structure of the ventricle. As shown in fig. 5, the diameter of the upper end of the lower plate 2 is the same as that of the rigid cylindrical frame 1, the diameter of the lower end of the lower plate 2 is larger than that of the upper end, and the lower plate 2 and the rigid cylindrical frame 1 are integrally connected.
Example 3
Referring to fig. 6-8, the present embodiment provides yet another dual disc atrioventricular valve replacement device comprising a rigid straight cylinder frame 1, a lower disc portion 2, a resilient anchor frame 3 and artificial leaflets 4. The hard straight cylinder frame 1 is provided with a cavity which penetrates through the upper end and the lower end of the hard straight cylinder frame 1, one end of the hard straight cylinder frame 1 extends out of the lower disc part 2, and the lower disc part 2 is flared outwards along the radial direction of the hard straight cylinder frame 1; the elastic anchoring frame 3 comprises a column part 32 and a ring part 31, the column part 32 is sleeved on the outer side of the rigid straight cylinder frame 1, the inner edge of the ring part 31 is connected with the column part 32, one end of the column part 32 far away from the ring part 31 is connected with the rigid straight cylinder frame 1, and one end of the ring part 31 close to the lower disc part 2 is provided with an upper disc surface surrounding the periphery of the rigid straight cylinder frame 1; the artificial valve blade 4 is arranged in the cavity and connected with the hard straight cylinder frame 1, and the connection position of the edge of the artificial valve blade 4 and the hard straight cylinder frame 1 is positioned at one side of the elastic anchoring frame 3 away from the lower disc part 2.
In this embodiment, the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 can be radially contracted, and the artificial valve leaflet 4 can be synchronously contracted along with the rigid straight cylinder frame 1. The elastic anchoring frame 3 is formed by weaving memory alloy wires, the hard straight cylinder frame 1 is hollow cylindrical, the hard straight cylinder frame 1 is made of metal pipes with a memory alloy effect in a laser cutting mode, the deformation resistance of the hard straight cylinder frame 1 is stronger than that of the elastic anchoring frame 3, and the hard straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 are all attached with biocompatible films 6. In fig. 6 to 8 of the present embodiment, the biocompatible film 6 on the elastic anchoring frame 3 is not shown. As shown in fig. 6, the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 have the structural characteristics of hollowed mesh, and the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 can be easily compressed by the structure.
In this embodiment, the upper disc surface is a conical surface with a cone angle of 150 degrees, and gradually moves away from the lower disc portion 2 from the inner side of the upper disc surface to the outer side of the upper disc surface. The conical upper disc surface can be well attached to the annular structure, stable anchoring is provided, and meanwhile, perivalvular leakage is further prevented. In order to realize stable cooperation of the double-disc-shaped atrioventricular valve replacement device and the conveying device, one end of the hard straight cylinder frame 1, which is far away from the lower disc part 2, is provided with a plurality of connecting parts 5, the connecting parts 5 are distributed at intervals along the circumferential direction of the hard straight cylinder frame 1, and the connecting parts 5 are provided with through holes 51.
The ring body 31 has a single-layer structure, and the column body 32 includes a first column 321 located between the ring body 31 and the lower disc 2; one end of the first post 321 far away from the ring portion 31 is fixedly connected with the rigid straight cylinder frame 1, and one end of the first post 321 close to the ring portion 31 is a free end and is connected with the inner edge of the ring portion 31. By connecting the inner edge of the ring body 31 with the free end of the first post 321, the ring body 31 is provided with a better deformability for adapting to the heart tissue.
In this embodiment, from one end of the lower disc portion 2 adjacent to the rigid straight barrel holder 1 to the other end of the lower disc portion 2, the diameter of the lower disc portion 2 gradually increases, and the outer surface of the lower disc portion 2 is a curved surface adapted to the physiological structure of the ventricle. As shown in fig. 7, the diameter of the upper end of the lower plate 2 is the same as that of the rigid cylindrical frame 1, the diameter of the lower end of the lower plate 2 is larger than that of the upper end, and the lower plate 2 and the rigid cylindrical frame 1 are integrally connected.
Referring to fig. 6 and 7, in this embodiment, a plurality of limiting blocks 7 are disposed at the lower end of the lower disc portion 2, and when the dual disc-shaped atrioventricular valve replacement device is in a contracted state, a limiting hole 8 having a substantially rectangular shape is defined between the limiting blocks 7 and the lower disc portion 2, as shown in fig. 14.
Example 4
Referring to fig. 9-11, the present embodiment provides yet another dual disc atrioventricular valve replacement device comprising a rigid straight cylinder frame 1, a lower disc portion 2, a resilient anchor frame 3 and artificial leaflets 4. The hard straight cylinder frame 1 is provided with a cavity which penetrates through the upper end and the lower end of the hard straight cylinder frame 1, one end of the hard straight cylinder frame 1 extends out of the lower disc part 2, and the lower disc part 2 is flared outwards along the radial direction of the hard straight cylinder frame 1; the elastic anchoring frame 3 comprises a column part 32 and a ring part 31, the column part 32 is sleeved on the outer side of the rigid straight cylinder frame 1, the inner edge of the ring part 31 is connected with the column part 32, one end of the column part 32 far away from the ring part 31 is connected with the rigid straight cylinder frame 1, and one end of the ring part 31 close to the lower disc part 2 is provided with an upper disc surface surrounding the periphery of the rigid straight cylinder frame 1; the artificial valve blade 4 is arranged in the cavity and connected with the hard straight cylinder frame 1, and the connection position of the edge of the artificial valve blade 4 and the hard straight cylinder frame 1 is positioned at one side of the elastic anchoring frame 3 away from the lower disc part 2.
In this embodiment, the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 can be radially contracted, and the artificial valve leaflet 4 can be synchronously contracted along with the rigid straight cylinder frame 1. The elastic anchoring frame 3 is formed by weaving memory alloy wires, and a biocompatible film 6 is attached to the elastic anchoring frame 3, wherein the hard straight cylinder frame 1 is hollow and cylindrical. As shown in fig. 9, the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 have the structural characteristics of hollowed mesh, and the rigid straight cylinder frame 1, the lower disc part 2 and the elastic anchoring frame 3 can be easily compressed by the structure.
In this embodiment, the upper disc surface is a conical surface, the cone angle of the conical surface is 150 degrees, and the upper disc surface is gradually far away from the lower disc part 2 from the inner side of the upper disc surface to the outer side of the upper disc surface. The conical upper disc surface can be well attached to the annular structure, stable anchoring is provided, and meanwhile, perivalvular leakage is further prevented. In order to realize stable cooperation of the double-disc-shaped atrioventricular valve replacement device and the conveying device, one end of the hard straight cylinder frame 1, which is far away from the lower disc part 2, is provided with a plurality of connecting parts 5, the connecting parts 5 are distributed at intervals along the circumferential direction of the hard straight cylinder frame 1, and the connecting parts 5 are provided with through holes 51.
In this embodiment, the ring body 31 has a single-layer structure, and the column portion 32 includes a second column 322, where the second column 322 and the lower disc 2 are located at two sides of the ring body 31; one end of the second post 322 far away from the ring body 31 is fixedly connected with the rigid straight cylinder frame 1, and one end of the second post 322 close to the ring body 31 is a free end and is connected with the inner edge of the ring body 31.
In this embodiment, from one end of the lower disc portion 2 adjacent to the rigid straight barrel holder 1 to the other end of the lower disc portion 2, the diameter of the lower disc portion 2 gradually increases, and the outer surface of the lower disc portion 2 is a curved surface adapted to the physiological structure of the ventricle. As shown in fig. 10, the diameter of the upper end of the lower plate 2 is the same as that of the rigid cylindrical frame 1, the diameter of the lower end of the lower plate 2 is larger than that of the upper end, and the lower plate 2 and the rigid cylindrical frame 1 are integrally connected.
Example 5
Referring to fig. 13, this embodiment differs from embodiment 3 only in the inclination direction of the first ring body 311 of the elastic anchoring frame 3, that is, embodiment 5 of the present invention can be obtained by replacing the elastic anchoring frame 3 in embodiment 3 with the elastic anchoring frame 3 in fig. 12.
The double-disc atrioventricular valve replacement device is delivered to a target position in a human body through a delivery device, and then the delivery device is utilized for deployment or release. The method comprises two modes: the transapical approach and the transfemoral vein-atrial septum approach.
Release implant mode one: after the double-disc-shaped atrioventricular valve replacement device is delivered to a target position by the delivery device, the lower disc part 2 of the double-disc-shaped atrioventricular valve replacement device is released at the annular position, the elastic anchoring frame 3 is released, the ring body part 31 and the lower disc part 2 of the elastic anchoring frame 3 respectively abut against the atrium and the ventricle wall by radial supporting force, and meanwhile, the middle rigid straight cylinder frame 1 abuts against the annular position by radial supporting force.
Releasing the implantation mode II: the sleeve 14 of the double disc-shaped atrioventricular valve replacement device is slowly retracted in the direction of the centripetal tip, the elastic anchoring frame 3 is released first, and then the lower disc part 2 is released. The dual disc atrioventricular valve replacement device is coupled to a delivery device, the dual disc atrioventricular valve replacement device is positioned at a target location using the delivery device, and the dual disc atrioventricular valve replacement device is completely dissociated from the delivery device after evaluating the functionality of the dual disc atrioventricular valve replacement device.
In the operation process, whether through the transapical approach or the femoral vein approach, the double-disc atrioventricular valve replacement device has the advantages of being convenient to operate and smooth to retract and release, and the double-disc valve replacement device can be recycled after being released, so that the placement position of the double-disc valve replacement device can be conveniently adjusted in vivo for the second time, and the double-disc valve replacement device is placed at an ideal position and achieves a stronger fixing effect.
The foregoing is merely illustrative of the present invention, and the present invention is not limited thereto, and any person skilled in the art will readily recognize that variations or substitutions are within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.