Valve fixing ring for replacement for pure aortic regurgitation

Abstract

The present invention relates to the technical field of valve repair. Disclosed is a valve fixing ring for replacement for pure aortic regurgitation. The valve fixing ring comprises a main body, protruding portions, and a connector, wherein the main body comprises a first end and a second end, the second end having a first position and second position relative to the first end; the protruding portions are connected to the main body, a plurality of protruding portions being distributed at intervals in the extension direction of the main body; and the connector is connected to the first end, the connector being configured to connect to an implantation device. When the second end is in the first position, the main body is in a ring shape, the second end is close to the connector, and each protruding portion at least partially protrudes from the surface of the main body and extends outwards in the radial direction of the ring shape; when the second end is in the second position, the main body is in a linear shape for easy storage, and each protruding portion fits to the surface of the main body. The valve fixing ring provided in the present invention can be delivered through the inside of a small catheter, and creates a strong fixing force between same and an aortic sinus, which can effectively prevent the valve fixing ring from slipping into a left ventricle outflow tract from the aortic sinus.

Description

Valve retaining ring for simple aortic regurgitation replacement Technical Field

[0001] The present invention relates to the technical field of valve repair, and in particular to a valve fixing ring for simple aortic regurgitation replacement. Background Art

[0002] Transcatheter aortic valve replacement (TAR) has become a first-line treatment for elderly patients with aortic stenosis. It can also be used for patients with aortic stenosis and varying degrees of aortic regurgitation. However, TAR is not routinely recommended for the treatment of isolated aortic regurgitation. Patients with aortic regurgitation have a hard, non-calcified aortic valve mass that can easily cause the implanted valve stent to dislodge and slip. Therefore, for patients with isolated aortic regurgitation, a suitable stent system needs to be designed to enhance its fixation.

[0003] Summary of the Invention

[0004] In order to solve the deficiencies of the prior art, the present invention provides a valve fixing ring for simple aortic regurgitation replacement.

[0005] To achieve the above objectives, the present invention provides the following technical solutions:

[0006] A valve fixing ring for simple aortic regurgitation replacement comprises a main body, a protrusion and a connector; wherein the main body comprises a first end and a second end, the second end having a first position and a second position relative to the first end; the protrusion is connected to the main body, and a plurality of protrusions are spaced apart along the extension direction of the main body; the connector is connected to the first end, and the connector is used to connect to an implant device; when the second end is in the first position, the main body is annular, the second end is adjacent to the connector, and at least part of the protrusion protrudes from the surface of the main body and extends outward along the radial direction of the ring; when the second end is in the second position, the main body is in a linear shape that is easy to be received, and the protrusion fits the surface of the main body.

[0007] Compared to existing technologies, the valve retaining ring of this invention can be straightened before surgery to facilitate delivery within the sheath, thereby reducing surgical difficulty. Once implanted at the target location, the raised portion of the valve retaining ring anchors in the aorta, strengthening the fixation between the valve retaining ring and the aortic sinus, preventing the valve retaining ring from slipping from the aortic sinus into the left ventricular outflow tract. The valve retaining ring for simple aortic regurgitation replacement described in this solution, while containing the word "replacement" in its name, does not constitute a limitation of the product; it can function independently or in conjunction with a replacement membrane frame.

[0008] In some embodiments, the protrusion includes a fixed end and a free end, the fixed end is fixedly connected to the main body; when the second end is in the first position, the free end is separated from the main body; when the second end is in the second position, the free end is in contact with the surface of the main body.

[0009] The structure of the raised portion in this embodiment can be realized during the cutting process of the main body, which has the advantage of simple processing and manufacturing process.

[0010] In some embodiments, the protrusion also includes a deformation section; when the second end is in the first position, the deformation section protrudes from the surface of the main body and extends radially outward along the ring shape; when the second end is in the second position, the deformation section fits the surface of the main body.

[0011] The arc-shaped protrusion in this embodiment simplifies the delivery of the valve fixing ring in the sheath, which helps to reduce the difficulty of the operation.

[0012] In some embodiments, the valve fixing ring for replacing isolated aortic regurgitation further includes a drawstring connected to the second end, and the drawstring can pass through the connector in one direction.

[0013] The pull rope provided in this embodiment can ensure that the valve fixing ring can provide sufficient clamping force so that the native valve is stably clamped between the valve fixing ring and the valve stent, further preventing the valve stent from falling off and sliding.

[0014] In some embodiments, the pull rope is provided with a knot, and the connecting part includes a lock body, a locking plate and a connecting body; the lock body includes a first side plate, a second side plate and a connecting plate, a wire threading groove is provided between the first side plate and the second side plate, the first side plate and the second side plate are connected by the connecting plate, and the first end is connected to the connecting plate; the locking plate is fixedly connected to the first side plate and / or the second side plate, the locking plate includes an elastic part located in the wire threading groove, the angle between the elastic part and the connecting plate is less than 90 degrees, and a notch is provided at one end of the elastic part, and the notch defines a hole for the one-way passage of the pull rope between the locking plate and the connecting plate; one end of the connecting body is movably connected to the lock body, and the connecting body is used to connect to the implant device.

[0015] In this embodiment, a relatively simple structure is used to realize the one-way passage of the pull rope through the connecting piece, which has the advantages of simple manufacturing process and stable performance.

[0016] In some embodiments, the lock body also includes a first rotating shaft located between the first side plate and the second side plate, the first rotating shaft is connected to the first side plate and / or the second side plate, one end of the connecting body is rotatably connected to the first rotating shaft, and the connecting body can rotate around the first rotating shaft.

[0017] The rotational connection between the connector and the lock body is achieved by the first rotating shaft. During the process of implanting the valve fixing ring into the target position of the human body, the position of the connector can be flexibly adjusted to facilitate the rapid and accurate placement of the valve fixing ring in the ideal position.

[0018] In some embodiments, when the second end is in the first position, the connector is perpendicular to the plane where the main body is located.

[0019] By rotating the connector to a position perpendicular to the plane where the main body is located, the valve fixing ring can be easily put on the native valve, reducing the difficulty of the surgical operation.

[0020] In some embodiments, when the second end is in the second position, the connector is collinear with the main body.

[0021] Placing the connector and the main body in the same line is beneficial for ensuring that the sheath has a smaller diameter, while also facilitating the delivery of the valve fixing ring within the sheath.

[0022] In some embodiments, the connecting member also includes a baffle rod parallel to the first rotating shaft, the baffle rod is connected to the first side plate and / or the second side plate, and a rope entry hole for the rope knot to pass through is provided between the baffle rod and the first rotating shaft, and the rope entry hole is located on the extension line of the axis of the main body.

[0023] The provided blocking rod can prevent the second end of the main body from being misaligned with the connecting piece, ensuring that the main body remains in the same plane after being bent into a ring, thereby ensuring a strong fixing force between the valve fixing ring and the aortic sinus.

[0024] In some embodiments, an end cap is provided on the end surface of the second end, and one end of the pull rope is connected to the center of the end cap, further ensuring that the main body remains in the same plane after being bent into a ring.

[0025] In some embodiments, the connector is provided with external threads for connecting with an implant device.

[0026] After the valve fixing ring is delivered to the target position of the human body and fixed, the push rod can be separated from the connector by rotating the push rod, which is simple and convenient to operate.

[0027] In some embodiments, the locking plate further includes a first fixing portion and a second fixing portion, the elastic portion is located between the first fixing portion and the second fixing portion, a first mounting hole is provided on the first side panel, a second mounting hole is provided on the second side panel, the first fixing portion is inserted into the first mounting hole, and the second fixing portion is inserted into the second mounting hole.

[0028] In this embodiment, the assembly method between the lock plate and the lock body is very simple, which helps to reduce the difficulty of processing.

[0029] In some embodiments, the connecting member further includes a boss, on which is provided a second rotating shaft perpendicular to the main body, and an insertion hole and a pin hole connected to the insertion hole are provided at one end of the main body adjacent to the connecting member, the boss is inserted into the insertion hole, and the second rotating shaft is inserted into the pin hole.

[0030] During the process of the main body deforming from a straight line to a ring shape, the connecting piece can rotate around the second rotating axis at a certain angle to adapt to the deformation of the main body, so that the deformed valve fixing ring has a more ideal shape, ensuring that the connecting piece on the valve fixing ring can also fit closely with the human body's native valve, thereby achieving the effect of preventing the valve stent from falling off or sliding.

[0031] In some embodiments, the valve retaining ring for isolated aortic regurgitation replacement further comprises a membrane covering the outer side of the main body, with the protrusion located within the membrane. When the second end is in the first position, the protrusion compresses and deforms the membrane to form a skirt structure. The membrane referred to herein is used to promote endothelialization and reduce thrombosis, and preferably takes the form of a molecular membrane or a biological membrane.

[0032] The provided skirt structure not only improves the stability of the valve fixing ring, but also helps to increase the speed of endothelialization of the device.

[0033] In some embodiments, a developing layer or a developing block is provided on the main body.

[0034] The provided developing layer enables the valve fixing ring to have good developing performance, making it easy to confirm the position of the valve fixing ring in the human body through ultrasound images and DSA transmission images during surgery.

[0035] In some embodiments, when the second end of the main body is in the first position, the outer diameter of the ring formed by the main body is 20 to 35 mm. Within this size range, the protrusion located on the outside of the main body can be stably anchored in the aorta, thereby preventing the valve fixing ring and the valve stent from slipping.

[0036] In some embodiments, the protrusion is integrally formed with the main body.

[0037] The raised portion and the main body are manufactured by an integrated molding process, which is conducive to simplifying the processing process and can also ensure that the raised portion and the main body are firmly connected.

[0038] The valve fixing ring provided by the present invention can be delivered in a smaller catheter through shape deformation, reducing surgical trauma; after release, the convex structure has a strong fixing force with the aortic sinus, which can effectively prevent the valve fixing ring from slipping from the aortic sinus into the left ventricular outflow tract. The device can provide a fixed support force for subsequent interventional aortic valve, thereby realizing the safe and effective treatment of patients with simple aortic valve regurgitation using the current clinical interventional aortic valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0040] FIG1 is a structural diagram of an embodiment of the present invention, in which the second end of the main body is located at a first position.

[0041] FIG2 is a structural diagram of another embodiment of the present invention, in which the second end of the main body is located at a first position.

[0042] FIG3 is a perspective view of a connecting member according to an embodiment of the present invention.

[0043] FIG4 is a top view of the connecting member in the embodiment of the present invention.

[0044] FIG5 is a cross-sectional view taken along line AA in FIG4 .

[0045] FIG6 is a schematic diagram of the pull rope passing through the connecting piece.

[0046] FIG. 7 is a structural diagram of a locking piece according to an embodiment of the present invention.

[0047] FIG8 is a structural diagram of an embodiment of the present invention when the second end of the main body is located at the second position.

[0048] FIG9 is a partial enlarged view of point B in FIG8 .

[0049] FIG10 is a partial enlarged view of point C in FIG8 .

[0050] FIG11 is a schematic diagram of a valve fixing ring according to an embodiment of the present invention when it is retracted into the sheath.

[0051] FIG. 12 is a schematic diagram showing a valve fixing ring in FIG. 1 or FIG. 2 after a biofilm is sheathed on the outer side of the main body.

[0052] FIG13 is a schematic diagram of an embodiment of the present invention when implanted in a human body.

[0053] FIG14 is a partial enlarged view of point D in FIG13.

[0054] FIG15 is a partial enlarged view of point E in FIG14 .

[0055] FIG16 is a schematic diagram of the valve fixing ring and the valve stent according to an embodiment of the present invention when used in conjunction with each other.

[0056] The following are the descriptions of the reference numerals:

[0057] In the figure: 1. Main body; 11. First end; 111. Insertion hole; 112. Pin hole; 12. Second end; 121. End cap; 2. Raised portion; 21. Fixed end; 22. Deformed section; 23. Free end; 3. Connector; 31. Lock body; 311. First side plate; 3111. First mounting hole; 312. Second side plate; 3121. Second mounting hole; 313. Connecting plate; 314. First rotating shaft; 315 , threading groove; 32, locking piece; 321, elastic part; 3211, notch; 322, first fixing part; 323, second fixing part; 33, connector; 34, stop rod; 35, boss; 36, second rotating shaft; 37, rope entry hole; 4, pull rope; 41, knot; 5, traction line; 6, push rod; 7, sheath; 8, biomembrane; 100, valve fixing ring; 200, native valve; 300, valve stent. DETAILED DESCRIPTION

[0058] To make the objectives, technical solutions, and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other implementations obtained by those of ordinary skill in the art without inventive effort are within the scope of protection of the present invention.

[0059] 1 to 16 , this embodiment provides a valve fixing ring 100 for simple aortic regurgitation replacement, which includes a main body 1, a protruding portion 2, and a connecting member 3; wherein the main body 1 includes a first end 11 and a second end 12, and the second end 12 has a first position and a second position relative to the first end 11; the number of the protruding portions 2 is six, each of which is connected to the main body 1, and the six protruding portions 2 are equidistantly spaced along the extension direction of the main body 1; the connecting member 3 is connected to the first end 11, and the connecting member 3 is used to connect to the implant device; the first end 11 of the main body 1 in FIG1 and FIG2 The two ends 12 are located in the first position. When the second end 12 is located in the first position, the main body 1 is in a closed circular shape, the second end 12 of the main body 1 contacts the connecting piece 3, and at least part of the protrusion 2 protrudes from the surface of the main body 1 and extends outward along the radial direction of the ring. In other words, the distance from the outermost end of the protrusion 2 to the center of the ring is greater than the outer diameter of the main body 1; in Figures 8 and 11, the second end 12 of the main body 1 is located in the second position. When the second end 12 is located in the second position, the main body 1 is in a straight line that is easy to be received, and the protrusion 2 is embedded in the surface of the main body 1 or fits tightly with the surface of the main body 1.

[0060] The connector 3 of the present invention can be a metal component or a polymer structure with sufficient strength, one end of which is fixedly connected to the first end 11 of the main body 1 by welding, riveting, or bonding. As shown in Figure 1, the main body 1 of the valve retaining ring 100 is cut and shaped from a metal tube with shape memory function, or as shown in Figure 8, is braided from a metal wire with shape memory function. In the embodiments shown in Figures 1 and 8, the raised portion and the main body are integrally molded. The use of an integral molding process for the raised portion and the main body facilitates simplified manufacturing while also ensuring a secure connection between the raised portion and the main body.

[0061] Before delivering the valve retaining ring 100 into the human body, the ring is first stretched into a straight shape and the protrusion 2 is compressed to bring it closer to the main body 1. After this process, the ring 100 is in the shape shown in FIG8 . The connector 3 on the ring 100 is then connected to the push rod 6 of the implantation device, and the ring 100 is then pulled into the sheath 7 . The state of the ring 100 after being received into the sheath 7 is shown in FIG11 . At this point, the diameter of the ring 100 is smaller than the inner diameter of the sheath 7 and significantly larger than the diameter of the push rod 6 . After the ring 100 is deformed into a straight shape (or strip shape), the sheath 7 used with the ring 100 can have a smaller diameter, which not only facilitates insertion of the sheath 7 into the human body but also facilitates delivery of the ring 100 within the sheath 7, significantly reducing the difficulty of the procedure.

[0062] The implantation process of the valve retaining ring 100 is as follows: first, the valve retaining ring 100 is delivered to the target location (the aortic root) in the human body via the sheath 7. Then, the valve retaining ring 100 is pushed out of the sheath 7 using the push rod 6. Because the valve retaining ring 100 is made of a shape-memory alloy, during the push-out process, the valve retaining ring 100 gradually returns to its annular shape as the release length increases, and the protrusion 2 separates from the main body 1. After separation from the main body 1, the protrusion 2 is anchored in the aorta, thereby strengthening the fixing force between the valve retaining ring 100 and the aortic sinus and preventing the valve retaining ring 100 from slipping from the aortic sinus into the left ventricular outflow tract.

[0063] In some embodiments, the raised portion 2 includes a fixed end 21 and a free end 23. The fixed end 21 is fixedly connected to the main body 1. When the second end 12 of the main body 1 is in the first position, the free end 23 is separated from the main body 1. When the second end 12 of the main body 1 is in the second position, the free end 23 is in contact with the surface of the main body 1. The raised portion 2 also includes a deformable segment 22 located between the fixed end 21 and the free end 23. When the second end 12 is in the first position, the deformable segment 22 protrudes from the surface of the main body 1 and extends outward along the radial direction of the annular shape, thereby forming an overall arc shape of the raised portion 2. When the second end 12 is in the second position, the deformable segment 22 is in contact with the surface of the main body 1.

[0064] As shown in Figure 1 , when the main body 1 is cut from a memory alloy tube, the raised portion 2 can be formed during the cutting process. Specifically, a portion of the tube is reserved during the cutting process to serve as the raised portion 2, which is then formed into an outwardly flaring curved shape through a series of steps. In this embodiment, the curved raised portion 2 simplifies delivery of the valve retaining ring 100 within the sheath 7.

[0065] In some embodiments, the valve retaining ring 100 for replacing isolated aortic regurgitation further includes a drawstring 4 connected to the second end 12, which can be passed through the connector 3 in one direction. When the valve retaining ring 100 is deformed into a ring-shaped state, that is, when the second end 12 of the main body 1 is in the first position, the drawstring 4 can be passed through the connector 3 to prevent the valve retaining ring 100 from being expanded, ensuring that the valve retaining ring 100 can provide sufficient clamping force to stably clamp the native valve 200 between the valve retaining ring 100 and the valve stent 300, further preventing the valve stent 300 from falling off or slipping.

[0066] As shown in Figure 11, in order to enable the pull rope 4 to pass through the connector 3 during the operation, a traction line 5 is passed through the sheath 7; when the valve fixing ring 100 is located in the sheath 7, the second end 12 of the main body 1 is located in the second position, one end of the traction line 5 passes through the connector 3 and is connected to the pull rope 4, and the entire pull rope 4 does not pass through the connector 3; after the valve fixing ring 100 is transported to the target position using the sheath 7, the valve fixing ring 100 is released from the sheath 7 by pushing the push rod 6. During the release process, the traction line 5 is pulled at the same time. The tension provided by the traction line 5 and the pull rope 4 can assist the deformation of the main body 1, so that the main body 1 quickly changes from a straight line to a ring shape. When the second end 12 of the main body 1 is about to contact the connector 3, the pull rope 4 is gradually pulled into the connector 3 under the traction of the traction line 5. After the second end 12 of the main body 1 contacts the connector 3, the traction line 5 is separated from the pull rope 4.

[0067] In the embodiment where a drawstring 4 is provided at the second end 12 of the main body 1, the main body 1 may also be made of a flexible material without memory properties. After the valve fixing ring 100 is released to the target position, the main body 1 may also be made into a ring shape by pulling the drawstring 4.

[0068] In some embodiments, in order to achieve one-way passage of the pull rope 4 through the connector 3, a knot 41 is provided on the pull rope 4. The connector 3 includes a lock body 31, a locking plate 32, and a connector 33. The lock body 31 includes an integrally formed first side plate 311, a second side plate 312, and a connecting plate 313. There is a gap between the first side plate 311 and the second side plate 312 to form a threading groove 315 for the traction line 5 and the pull line to pass through. The first side plate 311 and the second side plate 312 are connected by the connecting plate 313. The first end 11 of the main body 1 is connected to the connecting plate 313; the locking plate 32 is fixedly connected to the first side plate 311 and / or the second side plate 312. The locking plate 32 includes a hole located at The elastic portion 321 in the threading groove 315, the angle between the elastic portion 321 and the connecting plate 313 is less than 90 degrees, so that a non-90-degree inclination angle is formed between the elastic portion 321 and the connecting plate 313, and a notch 3211 is provided at one end of the elastic portion 321, and the notch 3211 defines a hole for the one-way passage of the pull rope 4 between the locking plate 32 and the connecting plate 313; one end of the connector 33 is movably connected to the lock body 31, and the connector 33 is used to connect to the push rod 6 of the implant device.

[0069] As shown in FIG9 , when the second end 12 of the main body 1 is in the second position, the pull line 5 passes through the threading groove 315 and through the notch 3211. After passing through the threading groove 315, the pull line 5 is connected to the pull rope 4. During the process of the main body 1 changing from a straight line to a ring shape, when the second end 12 of the main body 1 is about to contact the connector 3, the pull rope 4 enters the threading groove 315 under the pull of the pull line 5 and passes through the notch 3211 in a forward direction. During this process, the pull rope 4 drives the elastic portion 321 to elastically deform so that the pull rope 4 can pass through the notch 3211. The pulling force provided to the pull rope 4 by the pull line 5 is referred to as the forward pulling force herein. When the second end 12 of the main body 1 is in the second position, the drawstring 4 is inserted into the notch 3211. If the drawstring 4 is subjected to reverse tension, the elastic portion 321 will reduce its tilt angle due to the reverse tension, thereby reducing the size of the hole for the drawstring 4 to pass through. The elastic portion 321 squeezes the drawstring 4 and prevents the drawstring 4 from reversely passing through the notch 3211, thus achieving one-way locking. The knot 41 is much larger than the notch 3211, further enhancing one-way locking.

[0070] To achieve a movable connection between the connector 33 and the lock body 31, the lock body 31 further includes a first rotating shaft 314 located between the first side plate 311 and the second side plate 312. The first rotating shaft 314 is connected to the first side plate 311 and / or the second side plate 312. One end of the connector 33 is rotatably connected to the first rotating shaft 314, allowing the connector 33 to rotate about the first rotating shaft 314. The rotational connection between the connector 33 and the lock body 31 achieved by the provision of the first rotating shaft 314 allows the position of the connector 33 to be flexibly adjusted during implantation of the valve retaining ring 100 at a target location in the human body, thereby facilitating quick and accurate placement of the valve retaining ring 100 at the desired location.

[0071] When the second end 12 of the main body 1 is in the first position, the connector 33 is perpendicular to the plane where the main body 1 is located. As shown in Figures 13 and 14, after the valve fixing ring 100 is released at the target position in the body, the main body 1 becomes annular. By rotating the connector 33 to a position perpendicular to the plane where the main body 1 is located, the valve fixing ring 100 can be easily placed on the native valve 200, reducing the difficulty of the surgical operation. When the second end 12 of the main body 1 is in the second position, the connector 33 is collinear with the main body 1. As shown in Figure 11, when the valve fixing ring 100 is located in the sheath 7, the second end 12 of the main body 1 is in the second position. Making the connector 33 collinear with the main body 1 is conducive to ensuring that the sheath 7 has a smaller diameter, and at the same time, it can also facilitate the delivery of the valve fixing ring 100 in the sheath 7.

[0072] In some embodiments, the connector 3 further includes a stopper 34 parallel to the first rotating shaft 314. The stopper 34 is connected to the first side plate 311 and / or the second side plate 312. A rope entry hole 37 for passing the rope knot 41 is provided between the stopper 34 and the first rotating shaft 314. The rope entry hole 37 is located on an extension of the axis of the main body 1. An end cap 121 is provided on the end surface of the second end 12, and one end of the pull rope 4 is connected to the center of the end cap 121. As shown in FIG1 , when the second end 12 of the main body 1 is in the first position, the pull rope 4 passes through the rope entry hole 37 and into the threading groove 315, thereby confining the insertion position of the pull rope 4 within the rope entry hole 37. This prevents misalignment between the second end 12 of the main body 1 and the connector 3, ensures that the main body 1 remains in the same plane after being bent into a ring shape, and further ensures a strong fixing force between the valve retaining ring 100 and the aortic sinus.

[0073] In order to facilitate the connection between the connector 33 and the push rod 6 of the implant device, an external thread for connecting to the push rod 6 of the implant device is provided on the connector 33. After the valve fixing ring 100 is sent into the target position of the human body and fixed, the push rod 6 can be separated from the connector 33 by rotating the push rod 6. The operation is simple and convenient.

[0074] To connect the locking plate 32 to the lock body 31, the locking plate 32 further includes a first fixing portion 322 and a second fixing portion 323. The elastic portion 321 is located between the first fixing portion 322 and the second fixing portion 323. A first mounting hole 3111 is defined on the first side panel 311, and a second mounting hole 3121 is defined on the second side panel 312. The first fixing portion 322 is inserted into the first mounting hole 3111, and the second fixing portion 323 is inserted into the second mounting hole 3121. As shown in FIG3 , the first and second side panels 311 and 312 are approximately rectangular. The first and second mounting holes 3111 and 3121 are elongated and parallel to each other, with the first mounting holes 3111 being arranged substantially along the diagonal of the first side panel 311. As shown in FIG7 , the locking plate 32 is cut from a metal sheet, with two parallel slits cut into the metal sheet to form the first fixing portion 322, the second fixing portion 323, and the elastic portion 321. In this embodiment, the assembly method between the lock piece 32 and the lock body 31 is very simple, which helps to reduce the difficulty of processing.

[0075] In some embodiments, the connector 3 further includes a boss 35, on which is disposed a second rotating shaft 36 perpendicular to the main body 1. The main body 1, adjacent to the connector 3, is provided with a socket 111 and a pin hole 112 connected to the socket 111. The boss 35 is inserted into the socket 111, and the second rotating shaft 36 is inserted into the pin hole 112. When the main body 1 is cut from tubing, the through hole in the tubing itself constitutes the aforementioned socket 111. In this embodiment, the second rotating shaft 36 can be detachably connected to the boss 35, and can be a pin. During the process of the main body 1 transforming from a straight line to an annular shape, the connector 3 can rotate around the second rotating shaft 36 by a certain angle to accommodate the deformation of the main body 1. This allows the deformed valve retaining ring 100 to have a more ideal shape, ensuring that the connector 3 on the valve retaining ring 100 can also closely fit the native human valve 200, thereby preventing the valve stent 300 from falling off or slipping.

[0076] In some embodiments, the valve retaining ring 100 for simple aortic regurgitation replacement further includes a biomembrane 8 covering the outer surface of the main body 1, with the raised portion 2 positioned within the biomembrane 8. When the second end 12 is in the first position, the raised portion 2 compresses and deforms the biomembrane 8 to form a skirt structure. The biomembrane 8 may be a polymer membrane, such as a woven or fibrous membrane with good biocompatibility, such as PET or PTFE, or processed animal pericardium. The skirt structure not only enhances the stability of the valve retaining ring 100 but also helps accelerate the endothelialization of the device.

[0077] To facilitate intraoperative confirmation of the position of the valve retaining ring 100 within the human body via ultrasound and DSA radiographic imaging, the valve retaining ring 100 can be provided with excellent imaging properties, such as by providing a developing layer or block on the main body 1 or by adding a developing component to the material making up the main body 1. During implantation of the valve retaining ring 100, the position of the valve retaining ring 100 can be observed via DSA radiographic imaging. If the position is not ideal, the position of the valve retaining ring 100 can be adjusted by pushing or retracting the push rod 6. Furthermore, the sheath 7 is preferably an adjustable bend sheath 7, so that the valve retaining ring 100 can be adjusted to the aortic root by adjusting the distal angle of the sheath 7.

[0078] As shown in Figures 1 and 2 , when the second end 12 of the main body 1 is in the first position, the outer diameter of the ring formed by the main body 1 is 20 to 35 mm. Within this size range, the protrusion 2 located on the outside of the main body 1 can be stably anchored in the aorta, thereby preventing the valve retaining ring 100 and the valve stent 300 from slipping. In some embodiments, the main body 1 is roughened near the native human valve 200, for example, by increasing its surface roughness with a special coating or creating a concave and convex structure with sutures and a coating.

[0079] FIG16 is a schematic diagram of using the valve fixing ring 100 to fix the valve stent 300 at the aorta. As shown in the figure, the native human valve 200 is sandwiched between the valve fixing ring 100 and the valve stent 300 .

[0080] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A valve fixing ring for simple aortic regurgitation replacement, characterized in that: include: a body including a first end and a second end, the second end having a first position and a second position relative to the first end; A raised portion, the raised portion is connected to the main body, and a plurality of the raised portions are distributed at intervals along the extension direction of the main body; A connector, the connector being connected to the first end and being used to connect to an implant device; When the second end is located at the first position, the main body is annular, the second end is adjacent to the connecting member, and at least a portion of the protrusion protrudes from the surface of the main body and extends outwardly along the radial direction of the annular shape; When the second end is located at the second position, the main body is in a linear shape that is easy to be stored, and the protrusion is in contact with the surface of the main body.

2. The valve fixing ring for simple aortic regurgitation replacement according to claim 1, characterized in that: The protrusion includes a fixed end and a free end, the fixed end is fixedly connected to the main body; when the second end is located at a first position, the free end is separated from the main body; when the second end is located at a second position, the free end is in contact with the surface of the main body.

3. The valve fixing ring for simple aortic regurgitation replacement according to claim 1, characterized in that: The protrusion also includes a deformation section; when the second end is located at the first position, the deformation section protrudes from the surface of the main body and extends outward along the radial direction of the ring; when the second end is located at the second position, the deformation section fits with the surface of the main body.

4. The valve fixing ring for simple aortic regurgitation replacement according to claim 1, characterized in that: The invention also comprises a drawstring connected to the second end, wherein the drawstring can pass through the connecting member in one direction.

5. The valve fixing ring for simple aortic regurgitation replacement according to claim 4, characterized in that: The pull rope is provided with a knot, and the connecting piece comprises: A lock body, the lock body comprising a first side plate, a second side plate and a connecting plate, a wire threading groove is provided between the first side plate and the second side plate, the first side plate and the second side plate are connected through the connecting plate, and the first end is connected to the connecting plate; A locking plate, the locking plate is fixedly connected to the first side plate and / or the second side plate, the locking plate comprises an elastic portion located in the threading groove, the angle between the elastic portion and the connecting plate is less than 90 degrees, one end of the elastic portion is provided with a notch, and the notch defines a hole between the locking plate and the connecting plate for the draw cord to pass through in one direction; A connector, one end of which is movably connected to the lock body, and the connector is used to be connected to the implant device.

6. The valve fixing ring for simple aortic regurgitation replacement according to claim 5, characterized in that: The lock body also includes a first rotating shaft located between the first side plate and the second side plate, the first rotating shaft is connected to the first side plate and / or the second side plate, one end of the connecting body is rotatably connected to the first rotating shaft, and the connecting body can rotate around the first rotating shaft.

7. The valve fixing ring for simple aortic regurgitation replacement according to claim 6, characterized in that: When the second end is at the first position, the connecting body is perpendicular to the plane where the main body is located.

8. The valve fixing ring for simple aortic regurgitation replacement according to claim 7, characterized in that: When the second end is in the second position, the connector is collinear with the main body.

9. The valve fixing ring for simple aortic regurgitation replacement according to claim 6, characterized in that: The connecting member also includes a baffle rod parallel to the first rotating shaft, the baffle rod is connected to the first side plate and / or the second side plate, and a rope entry hole for the rope knot to pass through is provided between the baffle rod and the first rotating shaft, and the rope entry hole is located on the extension line of the axis of the main body.

10. The valve fixing ring for simple aortic regurgitation replacement according to claim 9, characterized in that: An end cover is provided on the end surface of the second end, and one end of the pull rope is connected to the center of the end cover.

11. The valve fixing ring for simple aortic regurgitation replacement according to claim 5, characterized in that: The connector is provided with an external thread for connecting with the implant device.

12. The valve fixing ring for simple aortic regurgitation replacement according to claim 5, characterized in that: The locking plate also includes a first fixing portion and a second fixing portion, the elastic portion is located between the first fixing portion and the second fixing portion, a first mounting hole is provided on the first side plate, a second mounting hole is provided on the second side plate, the first fixing portion is inserted into the first mounting hole, and the second fixing portion is inserted into the second mounting hole.

13. The valve fixing ring for simple aortic regurgitation replacement according to claim 5, characterized in that: The connecting member also includes a boss, on which a second rotating shaft perpendicular to the main body is provided, and an insertion hole and a pin hole connected to the insertion hole are provided at one end of the main body adjacent to the connecting member, the boss is inserted into the insertion hole, and the second rotating shaft is inserted into the pin hole.

14. The valve fixing ring for simple aortic regurgitation replacement according to any one of claims 1 to 13, characterized in that: It also includes a film wrapped around the outside of the main body, and the protrusion is located inside the body; when the second end is located at the first position, the protrusion presses the film to deform to form a skirt structure.

15. The valve fixing ring for simple aortic regurgitation replacement according to any one of claims 1 to 13, characterized in that: A developing layer or a developing block is arranged on the main body.

16. The valve fixing ring for simple aortic regurgitation replacement according to any one of claims 1 to 13, characterized in that: When the second end is located at the first position, the outer diameter of the ring formed by the main body is 20-35 mm.

17. The valve fixing ring for simple aortic regurgitation replacement according to any one of claims 1 to 13, characterized in that: The protrusion is integrally formed with the main body.

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