Adjustable anti-reflux stent and prosthetic valve device

Abstract

The application discloses an anti-reflux support and artificial valve device convenient to adjust and relates to the technical field of medical devices.The anti-reflux support convenient to adjust comprises connecting pieces, positioning pieces, fastening pieces, fixing pieces, clamping ends and marking pieces, the connecting pieces are arranged at intervals in the circumferential direction at the proximal end of the anti-reflux support convenient to adjust; the positioning pieces and the fastening pieces are arranged between adjacent connecting pieces, the positioning pieces and the fastening pieces are respectively curved towards the proximal end of the anti-reflux support convenient to adjust, and the clamping space for clamping the native valve leaflets is formed between the positioning pieces and the fastening pieces in the relaxed state; the fixing pieces are provided with pull wire through holes, the pull wire through holes are used for the pull wire to pass through so as to adjust the relaxation degree of the positioning pieces; the marking pieces are connected with the fixing pieces in correspondence, the pull wire through holes are at least partially exposed to the marking pieces; the clamping ends are arranged at the proximal end of the fastening pieces, and the anti-reflux support convenient to adjust is anchored in the installation environment through the clamping ends.The application can quickly and accurately capture the position of the native valve leaflets and improve safety.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an easily adjustable anti-reflux stent and artificial valve device. Background Technology

[0002] Due to its advantages such as minimal invasiveness and rapid recovery, transcatheter aortic valve replacement (TVR) is increasingly being used in surgeries. In surgeries where the native heart valve is replaced with an artificial valve due to disease, taking aortic valve replacement for aortic regurgitation as an example, early surgical methods required cutting the sternum to suture the artificial valve to the aortic annulus. Currently, this has gradually changed to TVR. An anti-regurgitation stent is an important device in TVR aortic valve replacement, often fabricated from nickel-titanium tubing. During the procedure, the anti-regurgitation stent, with the artificial valve leaflets sutured, is first gripped and then delivered via a delivery system. The stent is then released, causing it to expand and open the artificial valve leaflets while simultaneously fixing the native valve leaflets.

[0003] Chinese patent CN105125322A, published on December 9, 2015, discloses a novel artificial valve prosthesis. The stent comprises three clamping components and a support segment. The clamping components are located opposite the closure surface of the autologous valve leaflet during aortic sinus positioning and in the natural state. The support segment is located on one side of the closure surface of the autologous valve leaflet in the natural state. Therefore, after the artificial valve prosthesis is fully released, the autologous valve leaflet is located between the clamping components and the support segment. However, the installation environment for each novel artificial valve prosthesis varies. During positioning, the entire prosthesis needs to be adjusted multiple times using a delivery device to clamp the flexible autologous valve leaflet and initially position the clamping components opposite the closure surface of the autologous valve leaflet. This results in low positioning efficiency and can easily damage the installation environment during the adjustment process.

[0004] Therefore, it is necessary to develop an anti-backflow bracket that is easy to install and has higher safety. Summary of the Invention

[0005] The purpose of this application is to provide an easily adjustable anti-reflux stent and artificial valve device, which solves the problems of low positioning efficiency and easy damage to the installation environment caused by the need to adjust the position of the entire anti-reflux stent multiple times during the positioning process.

[0006] To achieve the above objectives, the present invention provides the following technical solution.

[0007] This application provides an easily adjustable anti-backflow stent, comprising: Connectors, each of which is circumferentially spaced at the proximal end of the easily adjustable anti-backflow support; The positioning element and the fastener are provided between adjacent connecting elements. The positioning element and the fastener are respectively bent toward the proximal end of the adjustable anti-backflow stent. In the extended state, in the radial direction of the adjustable anti-backflow stent, the proximal end of the positioning element is located outside its corresponding fastener. A clamping space for clamping the original leaflet is formed between the positioning element and the fastener. A fixing member is connected to the proximal end of the positioning member. The fixing member is provided with a pull wire through hole for the pull wire to pass through, so as to adjust the extension degree of the positioning member. A marker is connected to the fixing member, and the pull wire passes through the hole, at least partially exposed through the marker. The locking end is located at the proximal end of the fastener, and the easily adjustable anti-backflow bracket is anchored in the installation environment through the locking end.

[0008] Optionally, the marker is C-shaped, and the marker extends from its proximal end to its distal end, surrounding the proximal and distal ends of the fixing member.

[0009] Optionally, the marking member includes a first fixed plate and a central marking portion, the central marking portion corresponding to the outer surface of the fixing member, the first fixed plate extending from one end connected to the central marking portion to the other end, first conforming to the outer surface of the fixing member, then penetrating the fixing member, and then bending along the inner surface of the fixing member.

[0010] Optionally, the marking element further includes a second fixing plate, which extends from one end connected to the central marking portion to the other end, first adhering to the outer surface of the fixing element, then penetrating the fixing element, and then bending along the inner surface of the fixing element; or first adhering to the outer surface of the fixing element, then penetrating the positioning element, and then bending along the surface of the positioning element.

[0011] Optionally, the first fixing plate is connected to the distal end of the central marking portion, and the second fixing plate is connected to the proximal end of the central marking portion; The first fixing plate and the second fixing plate are bent in the same or opposite directions along the surface of the fixing member or the positioning member.

[0012] Optionally, the marking element further includes a first side portion, which partially conforms to a first side surface of the fixing element and partially conforms to the inner surface of the fixing element; The marking element also includes a second side portion, which partially conforms to the second side surface of the fixing element and partially conforms to the inner surface of the fixing element.

[0013] Optionally, the first fixed plate passes through the through hole of the pull wire; The inner wall of the hole through which the pull wire passes includes a connecting surface and a limiting surface. The connecting surface is used to fit against the first fixed plate, and the limiting surface clamps the first fixed plate to prevent the first fixed plate from shifting in the circumferential direction. The limiting surface and the connecting surface form the inner wall of the wire through hole; The limiting surface is arched.

[0014] Optionally, the fixing member includes a fixing plate and a limiting part. The two ends of the fixing plate are respectively connected to the positioning member and the limiting part. At the connection between the fixing plate and the limiting part, the surface of the limiting part protrudes at least partially from the surface of the fixing plate. The marking member is at least partially located on the fixing plate, and the pull wire through hole is provided on the limiting part.

[0015] Optionally, the positioning element includes a first positioning arm, a second positioning arm, and a proximal end of the positioning element, wherein the first positioning arm and the second positioning arm are connected through the proximal end of the positioning element; the proximal end of the fixing element is connected to the proximal end of the positioning element.

[0016] Optionally, the adjustable anti-reflux stent further includes an auxiliary component, at least one of the positioning components is provided with the auxiliary component, and the two ends of the auxiliary component are respectively connected to the first positioning arm and the second positioning arm; one or more V-shaped auxiliary portions with openings facing the proximal end of the adjustable anti-reflux stent are formed between the two ends of the auxiliary component; the outer surface of the V-shaped auxiliary portion is used to conform to the inner wall of the blood vessel. The V-shaped auxiliary part includes a first auxiliary arm, a second auxiliary arm, and a distal end of the auxiliary part, wherein the first auxiliary arm and the second auxiliary arm are connected through the distal end of the auxiliary part; When the easily adjustable anti-backflow support is in the extended state, the distal end of the first auxiliary arm bends toward the direction of its corresponding second auxiliary arm; the distal end of the second auxiliary arm bends toward the direction of its corresponding first auxiliary arm, and the proximal end of the first auxiliary arm bends toward the direction away from its corresponding second auxiliary arm; the proximal end of the second auxiliary arm bends toward the direction away from its corresponding first auxiliary arm. The auxiliary component has multiple V-shaped auxiliary parts arranged circumferentially, and the proximal end of the V-shaped auxiliary part near the first positioning arm is located in the middle of the first positioning arm. In the axial direction of the easily adjustable anti-backflow bracket, the distal end of the V-shaped auxiliary part in the contracted state is flush with or lower than the distal end of the positioning member, while in the extended state, the distal end of the V-shaped auxiliary part is higher than the distal end of the positioning member.

[0017] Optionally, the fastener includes a first fastening arm, a second fastening arm, and a fastener proximal end connecting the first fastening arm and the second fastening arm, wherein the first fastening arm and the second fastening arm are respectively connected to two adjacent connectors; The connector includes a positioning member connecting part, a fastener connecting part, and a sewing part. The sewing part has a sewing through hole and is located between the positioning member connecting part and the fastener connecting part. The connector also includes a connecting block and a web plate. The connecting block is connected to the positioning member connecting part through the web plate. The width of the web plate is smaller than the width of the connecting block.

[0018] Optionally, the locking end includes a plurality of locking end structural units, which are sequentially connected and form a hollow structure; the locking end structural unit includes a first locking unit facing the proximal end of the fastener and connected thereto, and a second locking unit located between adjacent first locking units; The positioning end structural unit includes a first connecting rod, a second connecting rod, a third connecting rod, and a fourth connecting rod that are connected and enclosed in sequence. The connection between the first connecting rod and the fourth connecting rod forms the distal end of the positioning end structural unit, and the connection between the second connecting rod and the third connecting rod forms the proximal end of the positioning end structural unit. When the easily adjustable anti-backflow support is in its extended state: the distal ends of the first connecting rod and the fourth connecting rod bend towards each other, the proximal ends of the second connecting rod and the third connecting rod bend towards each other, the proximal ends of the first connecting rod and the fourth connecting rod bend away from each other, and the distal ends of the second connecting rod and the third connecting rod bend away from each other.

[0019] Optionally, the adjustable anti-backflow bracket further includes a reinforcing mesh disposed between adjacent fasteners, the proximal end of the reinforcing mesh being connected to the distal end of the locking end; The reinforcing mesh includes a first self-expanding arc, with two adjacent fasteners connected to each end of the first self-expanding arc, and the locking end connected to the middle of the first self-expanding arc. The reinforcing mesh also includes a second self-expanding arc and a third self-expanding arc, the second self-expanding arc and its corresponding third self-expanding arc being distributed along the axial direction or along the circumferential direction.

[0020] Optionally, there are three connectors; The connectors are evenly distributed along the circumference of the easily adjustable anti-backflow bracket; Each of the aforementioned positioning components is provided with a fixing component; In the axial direction of the easily adjustable anti-backflow bracket, the distance between the proximal end of the positioning member and the proximal end of the locking end is between 4mm and 8mm. When the adjustable anti-backflow support is in the extended state: the positioning member gradually extends from its distal end to its proximal end in a direction away from the axis of the adjustable anti-backflow support, and the opening angle of the positioning member relative to the axis is between 2° and 14°; the locking end gradually extends from its distal end to its proximal end in a direction away from the axis, and the outward expansion angle of the locking end relative to the axis is between 6° and 14°. The connector, the positioning component, the fixing component, the fastener, and the locking end are integrally formed.

[0021] The present invention also provides an artificial valve device, comprising: An adjustable anti-backflow support as described in any of the preceding items; A pull wire passes through a pull wire through hole, and one pull wire controls the degree of extension of one or more of the positioning elements.

[0022] Optionally, the artificial valve device also includes: The film is applied and fixed to the fastener; Artificial leaflets, fixed to the membrane and the connector, are used to control the opening and closing of the installation channel; A leak-proof skirt is provided at the locking end to prevent side leakage from the easily adjustable anti-backflow bracket.

[0023] Compared with the prior art, the beneficial effects of this application are as follows: (1) The positioning component and fastener form a clamping space. A fixing component is set on the positioning component, and a pull wire through hole is set on the fixing component. During the positioning of the easily adjustable anti-reflux stent, the degree of expansion of the positioning component can be controlled by simply pulling the pull wire, and the size of the clamping space can be adjusted. Therefore, the doctor can flexibly control the expansion of the positioning component according to the specific conditions of the installation environment, quickly and accurately capture the position of the original leaflet, reduce the number of times the anti-reflux stent is repeatedly adjusted, and improve the positioning efficiency. At the same time, during the positioning process, the degree of expansion of the positioning component is flexibly controlled to avoid scratching human tissue, which improves the safety of the easily adjustable anti-reflux stent.

[0024] (2) A fixation device is set at the proximal end of the positioning device, and a marker is installed using the fixation device. The doctor can observe the position of the marker in the image during the operation, thereby quickly determining whether the proximal end of the positioning device reaches the sinus floor and determining the positioning information of the anti-reflux stent that is easy to adjust.

[0025] (3) The pull wire is passed through the hole and set on the fixing part, and the marker is installed on the fixing part. The function of controlling the extension of the positioning part and the function of positioning the adjustable anti-backflow stent are integrated into the position of the fixing part. While realizing these two functions, the length of the adjustable anti-backflow stent is not increased, avoiding the risk that the adjustable anti-backflow stent may touch His bundle or other human tissues due to its large length. At the same time, it also has the effect of compact structure and high space utilization.

[0026] (4) During the operation, the expansion of the positioning device can be flexibly controlled according to the specific conditions of the installation environment. Thus, the doctor can control the contraction of the positioning device according to the needs of the operation, and then use the delivery device to control the easily adjustable anti-reflux stent to be withdrawn a certain distance along the blood vessel, thereby achieving the reciprocating fine adjustment of the easily adjustable anti-reflux stent without damaging human tissue.

[0027] (5) The two ends of the positioning component are connected to the two connecting components one by one. The middle part of the positioning component is bent towards the apex to form the proximal end of the positioning component. When the pull line is pulled in and out, the positioning component moves around its two ends. The pull line is passed through the hole and set at the proximal end of the positioning component. The lever arm of the positioning component is large, which reduces the difficulty of controlling the movement of the positioning component. Attached Figure Description

[0028] The technical features and advantages of the present invention will be more fully understood by taking into account the accompanying drawings and the following detailed description.

[0029] Figure 1 This is a schematic diagram of the easily adjustable anti-backflow support of Embodiment 1 of the present invention in its extended state; Figure 2 This is an unfolded view of the easily adjustable anti-backflow stent of Embodiment 1 of the present invention in its contracted state, in which the markings are hidden; Figure 3 This is a front view of the easily adjustable anti-backflow support in its extended state according to Embodiment 1 of the present invention, in which the markings are omitted; Figure 4 for Figure 1 Enlarged view of part A; Figure 5 for Figure 2 Enlarged view of part B; Figure 6 This is a schematic diagram of the structure of the marker in Embodiment 1 of the present invention; Figure 7 This is a partial structural schematic diagram of an easily adjustable anti-backflow support according to another embodiment of the present invention; Figure 8 This is a partial structural schematic diagram of an easily adjustable anti-backflow support according to another embodiment of the present invention; Figure 9This is a schematic diagram of the easily adjustable anti-backflow support of Embodiment 2 of the present invention in its extended state; Figure 10 This is an unfolded view of the easily adjustable anti-backflow stent of Embodiment 2 of the present invention in its contracted state, in which the markings are hidden; Figure 11 This is a front view of the easily adjustable anti-backflow support of Embodiment 2 of the present invention in its extended state, where the markings are omitted; Figure 12 for Figure 9 Enlarged view of part C; Figure 13 for Figure 11 Enlarged view of part D; Figure 14 This is a partial structural diagram of Embodiment 2 of the present invention, used to illustrate the structure at the proximal end of the positioning member; Figure 15 This is a partial structural diagram of Embodiment 2 of the present invention, used to illustrate the structure at the proximal end of the positioning member; Figure 16 This is a schematic diagram of the structure of the marking member in Embodiment 2 of the present invention, wherein the first fixed plate, the second fixed plate, the first side portion, and the second side portion are in a non-bent state; Figure 17 This is a schematic diagram of the structure of the marking member in Embodiment 2 of the present invention, wherein the first fixed plate, the second fixed plate, the first side portion, and the second side portion are in a bent state; Figure 18 This is a schematic diagram of an easily adjustable anti-backflow support structure according to Embodiment 3 of the present invention, in which the markings are omitted; Figure label: Connector 1 Positioning component connecting part 11 Fastener connection part 12 Suture 13 Suture through hole 131 Connector block 14 Web 15 Positioning component 2 First positioning arm 21 Second positioning arm 22 Positioning component proximal end 23 24 slotted holes Auxiliary Component 3 V-shaped auxiliary part 31 First auxiliary arm 311 Second auxiliary arm 312 Auxiliary part distal end 313 Fastener 4 First fastening arm 41 Second fastening arm 42 Fastener proximal end 43 Card position 5 Carding end structural unit 51 First connecting rod 511 Second connecting rod 512 Third connecting rod 513 Fourth connecting rod 514 First card slot unit 52 Second card slot unit 53 Marker 6 Middle mark position 61 First fixed board 62 Central Marking Section 63 Second fixed board 64 First side 65 Second side 66 Fastener 7 Limiting part 71 Fixed plate 72 Pull the wire through hole 73 Connection surface 731 Limiting surface 732 First side view 74 Second side 75 Strengthen Network 8 First self-expanding arc 81 Second self-expansion arc 82 Third self-expansion arc 83 Detailed Implementation Unless otherwise defined, the technical or scientific terms used in this specification and claims shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0030] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0031] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0032] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0033] In any of the following embodiments, the adjustable anti-reflux stent has one end close to the apex of the heart and the other end far from the apex in the use state. During the description, the "proximal end" of a component refers to the end of the component close to the apex in the use state, and correspondingly, the "distal end" of a component refers to the end of the component far from the apex in the use state. The adjustable anti-reflux stent in any of the following embodiments can be extended and compressed. In the use state, it is in an extended state, defined as the "stretched state"; in the non-use state, for ease of storage and protection, it is artificially compressed radially to a certain state, defined as the "contracted state". In the following description of the adjustable anti-reflux stent, the terms "circumferential," "axial," "radial," and "axis" are all relative to the adjustable anti-reflux stent. It should be noted that "axial" here refers generally to the direction of the "axis," without any positional limitation. For example, when the "axis" extends vertically, "axial" is understood as the "vertical direction," not just the location of the "axis." When the outer surface of a component is mentioned in the following description, it refers to the side of the component that is opposite to the axis of the adjustable anti-reflux stent, i.e., the side opposite to the inner wall of the blood vessel. The following description of the adjustable anti-reflux stent involves the native leaflets. The side of the native leaflets that is in contact with each other when they are functioning normally is defined as the closure surface, and the side of the native leaflets opposite to the closure surface is defined as the non-closure surface.

[0034] Example 1 Please see Figures 1 to 6Understanding this embodiment. This embodiment provides an easily adjustable anti-regurgitation stent for use in heart valve replacement surgery. The easily adjustable anti-regurgitation stent, in its contracted state, is transported to the appropriate position via a delivery device and ultimately operates in its extended state. The easily adjustable anti-regurgitation stent has a hollow structure with open edges. The hollow portion is used to house an artificial leaflet to replace the original leaflet and achieve its function.

[0035] The easily adjustable anti-backflow bracket includes a bracket body and a marking component 6. The bracket body has a hollow structure with openwork around its sides. The bracket body includes a connector 1, a positioning component 2, a fastener 4, a fixing component 7, and a locking end 5.

[0036] Connector 1 is located at the distal end of the adjustable anti-backflow bracket and is spaced circumferentially along the adjustable anti-backflow bracket. Adjacent connectors 1 are connected by positioning elements 2 and fasteners 4, that is, positioning elements 2 and fasteners 4 are provided between any group of adjacent connectors 1.

[0037] The two ends of the positioning member 2 are connected to the two adjacent connecting members 1 in a one-to-one correspondence. The part between the two ends of the positioning member 2 is bent toward the proximal end of the anti-backflow bracket that is easy to adjust, that is, the positioning member 2 is bent toward the direction away from the connecting member 1, so that the positioning member 2 forms a shape with the opening facing the distal end of the anti-backflow bracket that is easy to adjust.

[0038] Similarly, the two ends of the fastener 4 are connected one-to-one with the two adjacent connectors 1. The portion between the two ends of the fastener 4 is bent toward the proximal end of the adjustable anti-backflow bracket, that is, the fastener 4 is bent toward the direction away from the connector 1, so that the fastener 4 forms a shape with the opening toward the distal end of the adjustable anti-backflow bracket.

[0039] The openings formed by the positioning element 2 and the fastener 4 face the same direction. In the axial direction, the fastener 4 is closer to the proximal end of the adjustable anti-reflux stent relative to its corresponding positioning element 2. In the extended state, in the radial direction, the proximal end of the positioning element 2 protrudes relative to the fastener 4, that is, the proximal end of the positioning element 2 is located outside its corresponding fastener 4. Thus, a clamping space for clamping the native leaflet is formed between the positioning element 2 and the fastener 4, which facilitates the insertion of the positioning element 2 between the native leaflet and the inner wall of the blood vessel, and places the native leaflet in the clamping space, thereby realizing the positioning of the adjustable anti-reflux stent.

[0040] The fixing member 7 is connected to the proximal end of the positioning member 2. The fixing member 7 is provided with a pull wire through hole 73, through which the pull wire passes to adjust the degree of extension of the positioning member 2.

[0041] The marker 6 is made of non-transparent metal. The marker 6 is connected to the fixing member 7. The marker 6 is detachably installed on the fixing member 7. The wire through hole 73 is at least partially exposed on the marker 6. That is, the marker 6 can partially occupy or cover the wire through hole, but will not completely cover the wire through hole 73.

[0042] The locking end 5 is located near the center of the fastener 4 and serves as an anchor. The adjustable anti-backflow bracket is anchored in the installation environment through the locking end to prevent the adjustable anti-backflow bracket from moving away from the apex.

[0043] Postoperatively, the positioning element 2 is positioned between the non-closed surface of the original leaflet and the inner wall of the blood vessel. The outer surface of the positioning element 2 contacts the inner wall of the blood vessel, and the inner surface contacts the non-closed surface of the original leaflet. The proximal end of the positioning element 2 contacts the sinus floor. A channel is formed between the closed surfaces of each original leaflet, and the fastener 4 is located inside this channel, i.e., the fastener 4 is located on one side of the closed surface of the original leaflet. This channel provides space for the artificial leaflet, which can be directly or indirectly installed on the fastener 4 to replace the original leaflet and realize its function.

[0044] As can be seen from the above description, the embodiments of the present invention have at least the following advantages: (1) The positioning component 2 and the fastener 4 form a clamping space. A fixing component 7 is set on the positioning component 2, and a pull wire through hole 73 is set on the fixing component 7. During the positioning of the easily adjustable anti-reflux stent, the extension degree of the positioning component 2 can be controlled by simply pulling the pull wire, and the size of the clamping space can be adjusted. Therefore, the doctor can flexibly control the extension of the positioning component 2 according to the specific conditions of the installation environment, quickly and accurately capture the position of the original leaflet, reduce the number of times the anti-reflux stent is repeatedly adjusted, and improve the positioning efficiency. At the same time, during the positioning process, the extension degree of the positioning component 2 is flexibly controlled to avoid scratching human tissue, which improves the safety of the easily adjustable anti-reflux stent.

[0045] (2) A fixation member 7 is set at the proximal end of the positioning member 2, and a marker 6 is installed using the fixation member 7. The doctor can observe the position of the marker 6 in the image during the operation, thereby quickly determining whether the proximal end of the positioning member 2 has reached the sinus floor and determining the positioning information of the anti-reflux stent that is easy to adjust.

[0046] (3) The pull wire is passed through the hole 73 and set on the fixing member 7, and the marker 6 is installed on the fixing member 7. The function of controlling the extension of the positioning member 2 and the function of positioning the adjustable anti-backflow stent are integrated in the position of the fixing member 7. While realizing these two functions, the length of the adjustable anti-backflow stent will not be increased, avoiding the risk that the adjustable anti-backflow stent will touch His bundle or other human tissues due to its large length. At the same time, it also has the effect of compact structure and high space utilization.

[0047] (4) During the operation, the positioner 2 can be flexibly extended according to the specific conditions of the installation environment. Thus, the doctor can control the positioner 2 to open according to the needs of the operation, and then use the delivery device to control the adjustable anti-reflux stent to be withdrawn a certain distance along the blood vessel, thereby achieving the reciprocating fine adjustment of the adjustable anti-reflux stent without damaging human tissue.

[0048] (5) The two ends of the positioning member 2 are connected to the two connecting members 1 in a one-to-one correspondence. The middle part of the positioning member 2 is bent towards the apex to form the proximal end of the positioning member 2. When the pull line is pulled in and out, the positioning member 2 moves around its two ends. The pull line is passed through the hole 73 and placed at the proximal end of the positioning member 2. The lever arm of the positioning member 2 is large, thereby reducing the difficulty of controlling the movement of the positioning member 2.

[0049] In this embodiment, the main body of the support is integrally formed. In other words, the connector 1, positioning component 2, fastener 4, fixing component 7, and locking end 5 are integrally formed. During processing, it can be cut from a nickel-titanium alloy tube. After the main body of the support is cut out, it is in a contracted state. Further processing can obtain an extended state. Admittedly, in some other embodiments, the main body of the support is formed by connecting multiple parts, which is also within the protection scope of this invention.

[0050] Continue reading Figures 1 to 3 In this embodiment, there are three connectors 1, and correspondingly, there are three positioning members 2 and three fasteners 4, which better accommodates the three native valve structures of the aorta. In some other embodiments, as an alternative, the number of connectors 1 can be set to other integers, such as 2, 4, 5, etc.

[0051] In this embodiment, the connectors 1 are evenly distributed along the circumference of the easily adjustable anti-reflux stent, resulting in a relatively uniform force between each connector 1 and the inner wall of the blood vessel. This reduces the risk of damage caused by uneven distribution of the connectors 1 leading to localized stress concentration on the inner wall of the blood vessel. Admittedly, in some other embodiments, the varying spacing between adjacent connectors 1 is also within the scope of protection of this invention.

[0052] In this embodiment, all positioning elements 2 and all fasteners 4 adopt the same structure, further improving the uniformity of the force between the easily adjustable anti-reflux stent and the vascular wall. Admittedly, in other embodiments, different structures may be used for the positioning elements 2 and / or different structures for the fasteners 4, which are also within the scope of protection of this invention.

[0053] In this embodiment, each positioning element 2 is provided with a fixing element 7. Correspondingly, each positioning element 2 also has a pull wire through hole 73 and a marker 6, so that the degree of expansion of each positioning element 2 can be controlled. In practical applications, the degree of expansion of each positioning element 2 can be controlled synchronously, individually, or any two can be controlled synchronously. When the pull wire controls the synchronous opening and closing of each positioning element 2, the opening angle of each positioning element 2 can be the same, and the positioning element 2 can quickly capture the original leaflet, thereby quickly implanting the easily adjustable anti-reflux stent into the human body. However, when facing irregular and / or original leaflet deformed due to lesions, it is difficult to insert the positioning element 2 between the non-closed surface of the original leaflet and the inner wall of the blood vessel. The pull wire can be used to individually control the opening angle of the positioning element 2 to capture the corresponding original leaflet, thereby improving the accuracy and efficiency of positioning the easily adjustable anti-reflux stent during the operation.

[0054] The fixing member 7 gradually approaches the axis of the adjustable anti-reflux support from its proximal end to its distal end. It can also be understood that the fixing member 7 is inclined relative to the axis, so that the distal end of the fixing member 7 can abut against the non-closed surface of the original leaflet.

[0055] The fixing member 7 includes a limiting part 71 for preventing the marker 6 from detaching from the distal end of the fixing member 7. The fixing member 7 also includes a fixing plate 72, on which the marker 6 is mounted. One end of the fixing plate 72 is connected to the positioning member 2, and the other end is connected to the limiting part 71. At the connection between the fixing plate 72 and the limiting part 71, at least a portion of the surface of the limiting part 71 protrudes relative to the surface of the fixing plate 72 to limit the marker 6. A pull wire through hole 73 is provided on the limiting part 71.

[0056] In practical applications, the length of the fixing plate 72 can be set to be greater than the length of the marker 6. The marker 6 can be displaced axially along the fixing plate 72, so as to leave a margin for the installation of the marker 6 and facilitate the quick installation of the positioning part 2. As an alternative, the distal end of the marker 6 can be abutted against the limiting part 71, and the proximal end of the marker 6 can be abutted against the proximal end of the fixing part 7 or against the positioning part 2, so that the displacement freedom of the marker 6 on the axis is constrained, eliminating the risk of damage to the inner wall of the blood vessel and the original valve leaflet caused by the axial movement of the marker 6.

[0057] In this embodiment, the limiting part 71 is a plate with a circular outline. In some other embodiments, as an alternative, the limiting part 71 may be a protrusion structure located on the fixing plate 72, or a baffle partially embedded in the fixing plate 72.

[0058] like Figure 6As shown, in this embodiment, the marker 6 is C-shaped and extends from its proximal end to its distal end. The marker 6 surrounds the proximal and distal ends of the fixing member 7, that is, the marker 6 surrounds the surface of the fixing plate 72. In specific applications, the marker 6 can be a bendable plate. During installation, the middle marking position 61 of the bendable plate is attached to the fixing plate 72 of the fixing member 7, and then the two sides of the bendable plate are bent twice continuously against the fixing plate 72. The thickness of the middle marking position 61 can be set to be less than the thickness of other positions of the bendable plate, which effectively reduces the influence of the marker 6 on the flatness of the outer side of the positioning member 2 and reduces the impact of the unevenness of the proximal end of the positioning member 2 on the inner wall of the blood vessel.

[0059] Continue reading Figures 1 to 3 In this embodiment, when the adjustable anti-reflux stent is in its extended state, the positioning member 2 gradually extends from its distal end to its proximal end away from the axis of the adjustable anti-reflux stent. This can also be understood as the positioning member 2 being axially inclined relative to the adjustable anti-reflux stent, so that the distal end of the positioning member 2 abuts against the non-closed surface of the original leaflet. In this embodiment, the opening angle of the positioning member 2 relative to the axis is between 2° and 14°, which improves the fixation effect of the original leaflet without pressing the original leaflet into the installation channel and affecting the operation of the artificial leaflet.

[0060] refer to Figure 3 To understand this, in the extended state, the distance H between the proximal end of the positioning member 2 and the proximal end of the locking end 5 along the axial direction of the easily adjustable anti-backflow stent can be any value between 4mm and 8mm. This reduces the risk of the locking end 5 contacting the His bundle. This embodiment uses 6mm; other embodiments may use 4mm or 8mm.

[0061] like Figures 1 to 3 As shown, the positioning element 2 includes a first positioning arm 21, a second positioning arm 22, and a proximal end 23. The proximal ends of the first positioning arm 21 and the second positioning arm 22 are connected by the proximal end 23. In this embodiment, the first positioning arm 21 and the second positioning arm 22 are symmetrically arranged, and the proximal end 23 is located in the middle of the positioning arm. Figure 2 As shown, when the easily adjustable anti-reflux stent in its contracted state is cut along the axial direction and unfolded, the first positioning arm 21 and the second positioning arm 22 are straight, and the proximal end 23 of the positioning element is arc-shaped. The arc-shaped proximal end 23 of the positioning element increases the contact area with the sinus floor, reduces the contact stress with the sinus floor, and reduces the risk of damage to the sinus floor and the risk of valve annulus rupture.

[0062] The adjustable anti-reflux stent also includes an auxiliary component 3. At least one positioning component 2 is provided with the auxiliary component 3. One or more openings are formed between the two ends of the auxiliary component 3, facing the proximal end of the adjustable anti-reflux stent. The openings of the V-shaped auxiliary component 31 face opposite directions to the openings formed by the positioning component 2. The outer surface of the V-shaped auxiliary component 31 is used to conform to the inner wall of the blood vessel, increasing the contact area with the inner wall of the blood vessel and increasing the support force in the radial and circumferential directions.

[0063] As can be seen from the above, this embodiment has at least the following advantages: (1) An auxiliary component 3 is provided on the positioning component 2. The outer surface of the auxiliary component 3 contacts the blood vessel, which increases the contact area between the adjustable anti-reflux stent and the inner wall of the blood vessel, improves the static friction between the two, and reduces the risk of displacement of the adjustable anti-reflux stent relative to the inner wall of the blood vessel, thereby improving the positional stability of the adjustable anti-reflux stent. On the other hand, it also increases the contact area between the adjustable anti-reflux stent and the original leaflet, improves the fixation effect on the original leaflet, thereby enhancing the functional stability of the adjustable anti-reflux stent.

[0064] (2) The adjacent connecting parts 1 and the positioning parts 2 between them together form an open hollow area with the opening facing upward. By setting the auxiliary part 3 in the hollow area and making the outer surface of the auxiliary part 3 contact the blood vessel, the radial and circumferential support of the adjustable anti-reflux stent is enhanced, and the positional stability of the adjustable anti-reflux stent is further improved. At the same time, the contact area with the original leaflet is increased, and the fixation effect on the original leaflet is improved, thereby further improving the functional stability of the adjustable anti-reflux stent.

[0065] (3) The distal end of the adjustable anti-reflux stent makes point contact with the inner wall of the blood vessel through the connector 1, and also makes linear contact through the V-shaped auxiliary part 31. This improves the continuity of the contact area between the distal end of the adjustable anti-reflux stent and the inner wall of the blood vessel in the circumferential direction, thereby improving the positional stability of the adjustable anti-reflux stent. At the same time, it also improves the continuity of the contact area between the distal end of the adjustable anti-reflux stent and the original leaflet in the circumferential direction, further improving the positional stability of the adjustable anti-reflux stent.

[0066] (4) The positioning member 2 bends away from the connecting member 1. The opening formed by the positioning member 2 faces the distal end of the adjustable anti-backflow bracket. The opening of the V-shaped auxiliary part 31 faces the opposite direction to the opening formed by the positioning member 2. Thus, the distal end of the V-shaped auxiliary part 31 is closer to the cross section where the connecting part 1 is located, or can be located at the cross section where the connecting part 1 is located. In the axial direction, the distance between the proximal end of the positioning member 2 and the connecting member 1 is large, making it difficult to provide a large circumferential support force for the connecting member 1. On the contrary, the distal end of the V-shaped auxiliary part 31 is closer to the cross section where the connecting member 1 is located. Therefore, the auxiliary part 3 can more effectively share the force at the connecting member 1 and cooperate with the connecting member 1 to improve the circumferential support force of the adjustable anti-backflow bracket.

[0067] (5) Compared with the structure of the auxiliary component 3 consisting of a single V-shaped auxiliary part 31, the auxiliary component 3 of this embodiment includes at least two V-shaped auxiliary parts 31. The angle of each V-shaped auxiliary part 31 is smaller, the deformation of the V-shaped auxiliary part 31 during the process from the contracted state to the extended state is small, and it is not easy to break, which improves the reliability of the adjustable anti-backflow support.

[0068] (6) The proximal end of the adjustable anti-reflux stent can be anchored by the locking end 5, and the distal end can be fixed on the inner wall of the blood vessel by the connector 1 and the auxiliary part 3. The position between the proximal and distal ends of the adjustable anti-reflux stent can also be supported on the inner wall of the blood vessel by the positioning part 2. Thus, the adjustable anti-reflux stent has higher stability and reliability as a whole.

[0069] like Figures 1 to 3 As shown, the bending amplitude of the positioning member 2 is greatest at its proximal end 23. The two ends of the auxiliary member 3 are connected to the first positioning arm 21 and the second positioning arm 22, respectively. Thus, in the circumferential direction, as the auxiliary member 3 extends from one end to the other, it crosses the position corresponding to the proximal end 23 of the positioning member. That is, the auxiliary member 3 crosses the area of ​​large bending amplitude of the positioning member 2, optimizing the stress distribution between the auxiliary member 3 and the positioning member 2. Admittedly, in some other embodiments, as an alternative, both ends of the auxiliary member 3 are disposed on the first positioning arm 21 or the second positioning arm 22, which is also within the scope of protection of this invention.

[0070] like Figures 1 to 3As shown, in this embodiment, along the axial direction of the easily adjustable anti-reflux stent, the proximal end of the V-shaped auxiliary part 31 is located at the middle of the first positioning arm 21. Similarly, the proximal end of the V-shaped auxiliary part 31 is also located at the middle of the second positioning arm 22. In the extended state, the axial distance between the first positioning arm 21 and the second positioning arm 22 is relatively large from the middle of the first positioning arm 21 to its distal end. Setting the V-shaped auxiliary part 31 to extend from the middle of the first positioning arm 21 away from the proximal end of the easily adjustable anti-reflux stent not only enhances the support force but also improves the fixation effect on the original leaflet.

[0071] like Figure 2 As shown, the auxiliary member 3 is provided with multiple V-shaped auxiliary parts 31. In the contracted state, the distal end of the V-shaped auxiliary part 31 is flush with or lower than the distal end of the positioning member 2, which reduces the interference of the auxiliary member 3 on the connection between the connector 1 and the delivery device. Due to the provision of multiple V-shaped auxiliary parts 31, the opening angle of the first auxiliary arm 311 and the second auxiliary arm 312 is small during the process of the stable anti-reflux stent from the contracted state to the extended state. Therefore, the change amplitude of the auxiliary member 3 relative to the axis is small. So, in the extended state, the distal end of the V-shaped auxiliary part 31 is higher than the distal end of the positioning member 2. Thus, the area between the two distal ends of the positioning member 2 can not only be supported on the inner wall of the blood vessel by the distal end of the auxiliary member 3, but also contact the inner wall of the blood vessel and the original valve leaflet by the proximal end of the auxiliary member 3.

[0072] In this embodiment, each positioning member 2 is provided with an auxiliary member 3, that is, each of the three positioning members 2 has at least two V-shaped auxiliary parts 31, which makes the distal end of the adjustable anti-reflux stent more uniformly stressed in the circumferential direction, reducing the risk of damage caused by uneven distribution of the connector 1 leading to local stress concentration on the vascular wall.

[0073] Continue reading Figures 1 to 3 In this embodiment, the auxiliary component 3 has two V-shaped auxiliary parts 31, that is, two V-shaped auxiliary parts 31 are respectively provided on the three positioning components 2. This not only ensures that the deformation of the V-shaped auxiliary parts 31 is small during the switching between the contracted and extended states, but also ensures that the elasticity of the auxiliary component 3 is moderate. One end of each V-shaped auxiliary part 31 is connected to the positioning component 2, and the other end is connected to another V-shaped auxiliary part 31.

[0074] like Figures 1 to 3As shown, the V-shaped auxiliary part 31 includes a first auxiliary arm 311, a second auxiliary arm 312, and a distal end 313. The first auxiliary arm 311 and the second auxiliary arm 312 are connected by the distal end 313, avoiding a sharp angle between the distal ends of the first auxiliary arm 311 and the second auxiliary arm 312. This reduces the risk of damage to the vascular wall or the original valve leaflet during elastic deformation and switching between the extended and contracted states. In this embodiment, the distal end 313 of the auxiliary part adopts an arc-shaped structure, further ensuring safety.

[0075] like Figure 2 As shown, when the easily adjustable anti-backflow support in its contracted state is cut along the axial direction and unfolded, the first auxiliary arm 311 and the second auxiliary arm 312 are in a straight line shape.

[0076] like Figure 1 and Figure 3 As shown, when the easily adjustable anti-backflow support is in the extended state, the first auxiliary arm 311 and the second auxiliary arm 312 have curved structures. Specifically, the distal end of the first auxiliary arm 311 bends towards its corresponding second auxiliary arm 312, and the distal end of the second auxiliary arm 312 bends towards its corresponding first auxiliary arm 311. This results in a relatively small angle formed by the distal ends of the V-shaped auxiliary parts 31. When switching between the extended and retracted states, the distal ends of the V-shaped auxiliary parts 31 can better absorb the force and are less prone to breakage. The proximal end of the first auxiliary arm 311 bends away from its corresponding second auxiliary arm 312, and the proximal end of the second auxiliary arm 312 bends away from its corresponding first auxiliary arm 311. This not only optimizes the force distribution but also reduces the angle formed by the connection points of adjacent V-shaped auxiliary parts 31. When switching between the extended and retracted states, this connection point can better absorb the force and is less prone to breakage. The V-shaped auxiliary part 31 is configured in the above structure, that is, the proximal end and the distal end of the first auxiliary arm 311 have different bending directions, and the proximal end and the distal end of the second auxiliary arm 312 have different bending directions. Without increasing the straight distance between the proximal end and the distal end of the auxiliary part 3, the total length of the auxiliary part 3 is increased, the contact area between the auxiliary part 3 and the vascular wall and the original valve is increased, and the stability and reliability of the easily adjustable anti-reflux stent are improved.

[0077] like Figure 1 and Figure 3 As shown in this embodiment, when the easily adjustable anti-reflux stent is in the extended state, the first auxiliary arm 311 extends smoothly along the curve from its proximal end to its distal end, and the second auxiliary arm 312 extends smoothly along the curve from its proximal end to its distal end. This not only helps to optimize the force distribution, but also reduces the risk of friction against the inner wall of the blood vessel and the original valve leaflet.

[0078] Fastener 4 includes a first fastening arm 41, a second fastening arm 42, and a proximal end 43 connecting the first fastening arm 41 and the second fastening arm 42. The distal end of the first fastening arm 41 and the distal end of the second fastening arm 42 are respectively connected to two adjacent connectors 1. Figure 2 As shown, when the adjustable anti-backflow support in the contracted state is cut along the axial direction and unfolded, the first fastening arm 41 and the second fastening arm 42 are straight, and the proximal end 43 of the fastener is arc-shaped; when the adjustable anti-backflow support is in the extended state, the first fastening arm 41 and the second fastening arm 42 are curved.

[0079] like Figures 1 to 3 As shown, the connector 1 includes a positioning connector 11, a fastener connector 12, and a suture part 13. The suture part 13 is provided with a suture through hole 131 for suturing the distal end of the artificial valve. In this embodiment, the suture through hole 131 is an elongated hole, which improves the convenience of suturing. The suture part 13 is located between the positioning connector 11 and the fastener connector 12.

[0080] like Figures 1 to 3 As shown, the connector 1 also includes a connecting block 14 and a web 15. The connecting block 14 is connected to the positioning connector 11 via the web 15. The width of the web 15 is smaller than the width of the connecting block 14. During the delivery of an adjustable anti-reflux stent via catheter, the connecting block 14 is connected to the delivery device. In use, the connecting block 14 is attached to the inner wall of the blood vessel.

[0081] Continue reading Figures 1 to 3 In this embodiment, when the adjustable anti-backflow stent is in the extended state: the locking end 5 gradually extends away from the axis of the adjustable anti-backflow stent from its distal end to its proximal end, and the outward expansion angle of the locking end 5 relative to the axis of the adjustable anti-backflow stent is between 6° and 14°.

[0082] like Figures 1 to 3 As shown, the positioning end 5 includes several positioning end structural units 51. In this embodiment, the positioning end structural units 51 are sequentially connected and form a hollow structure, thereby facilitating a more uniform and stable positioning effect of the proximal end of the adjustable anti-backflow stent throughout the entire circumference. In some other embodiments, as an alternative, the positioning end structural units 51 can be spaced out and distributed along the circumference of the adjustable anti-backflow stent.

[0083] The locking end structural unit 51 includes a first locking unit 52 directly opposite to and connected to the proximal end of the fastener 4, and a second locking unit 53 located between adjacent first locking units 52. An odd number of second locking units 53 are arranged between adjacent first locking units 52, such as 5 or 7 second locking units 53. This ensures that during the switching between the extended and contracted states, the deformation of the first locking units 52 and the second locking units is small, and the radial and circumferential support forces of the entire locking end 5 are within an optimal range. It should be noted that the first locking units 52 and the second locking units 53 can adopt the same structure; this embodiment defines different names based on their different positions.

[0084] like Figures 1 to 3 As shown, the locking end structure unit 51 includes several connecting rods, specifically including a first connecting rod 511, a second connecting rod 512, a third connecting rod 513, and a fourth connecting rod 514 that are connected and enclosed in sequence. During the switching between the contracted state and the extended state, the deformation at the connection point of the adjacent connecting rods is relatively large, and correspondingly, the stress at these positions is relatively large. In this embodiment, each connecting rod adopts a structure that is thick at both ends and thin in the middle, which optimizes the stress distribution of the connecting rod.

[0085] The connection between the first connecting rod 511 and the fourth connecting rod 514 forms the distal end of the locking end structural unit 51, and the connection between the second connecting rod 512 and the third connecting rod 513 forms the proximal end of the locking end structural unit 51. When the easily adjustable anti-backflow support is in its extended state: the distal ends of the first connecting rod 511 and the fourth connecting rod 514 bend towards each other, and the proximal ends of the second connecting rod 512 and the third connecting rod 513 bend towards each other; the proximal ends of the first connecting rod 511 and the fourth connecting rod 514 bend away from each other, and the distal ends of the second connecting rod 512 and the third connecting rod 513 bend away from each other; for example... Figure 2 As shown, when the adjustable anti-backflow support in its contracted state is cut along the axis and unfolded, the first connecting rod 511, the second connecting rod 512, the third connecting rod 513 and the fourth connecting rod 514 are respectively in a straight line shape.

[0086] like Figures 1 to 3As shown, the easily adjustable anti-reflux stent also includes a reinforcing mesh 8 disposed between adjacent fasteners 4, with the proximal end of the reinforcing mesh 8 connected to the distal end of the locking end 5. By using the reinforcing mesh 8 to connect adjacent fasteners 4 and the locking end 5 between two fasteners 4, the radial and circumferential support force of the easily adjustable anti-reflux stent is improved, and the degree of deformation caused by external forces is reduced. The reinforcing mesh 8 also effectively prevents the original leaflet from intruding into the installation channel and interfering with the operation of the artificial leaflet. In this embodiment, a reinforcing mesh 8 is provided between any two adjacent fasteners 4, meaning the easily adjustable anti-reflux stent has three reinforcing meshes 8.

[0087] The reinforcing mesh 8 includes a first self-expanding arc 81. Two adjacent fasteners 4 are connected to the two ends of the first self-expanding arc 81, and a locking end 5 is connected to the middle of the first self-expanding arc 81. In its extended state, the first self-expanding arc 81 forms an opening facing the distal end of the easily adjustable anti-backflow support. By simultaneously connecting two fasteners 4 and the locking end 5 using the first self-expanding arc 81, the stability between the fasteners 4 and the locking end 5 is enhanced. In this embodiment, the end of the first self-expanding arc 81 is connected to the middle position of either the first fastening arm 41 or the middle position of the second fastening arm 42 to obtain better radial and circumferential support and stability.

[0088] The reinforcing net 8 also includes a second self-expanding arc 82 and a third self-expanding arc 83. In the extended state, the openings of the second self-expanding arc 82 and the third self-expanding arc 83 face opposite directions. The second self-expanding arc 82 and the third self-expanding arc 83 can have different positional relationships. Some of these positional relationships are explained below: like Figures 1 to 3 As shown, the second self-expanding arc 82 and its corresponding third self-expanding arc 83 are distributed along the circumference of the adjustable anti-backflow bracket, and the two are connected at the middle position; the two ends of the second self-expanding arc 82 are respectively connected to the fastener 4 and the first self-expanding arc 81, and the two ends of the third self-expanding arc 83 are respectively connected to another fastener 4 and the first self-expanding arc 81. like Figure 7 As shown, in some other embodiments, the second self-expanding arc 82 and its corresponding third self-expanding arc 83 are distributed along the circumference of the adjustable anti-backflow bracket, and the two are close to each other but not connected in the middle position; the two ends of the second self-expanding arc 82 are respectively connected to the fastener 4 and the first self-expanding arc 81, and the two ends of the third self-expanding arc 83 are respectively connected to another fastener 4 and the first self-expanding arc 81. like Figure 8 As shown, the second self-expanding arc 82 and its corresponding third self-expanding arc 83 are distributed along the axial direction of the adjustable anti-backflow bracket, and the two are not connected in the middle position; the two ends of the second self-expanding arc 82 are connected to two adjacent fasteners 4 in a one-to-one correspondence, and the two ends of the third self-expanding arc 83 are respectively connected to the first self-expanding arc 81. In some other embodiments, the second self-expanding arc 82 and its corresponding third self-expanding arc 83 are distributed along the axial direction of the adjustable anti-backflow bracket and are connected at the middle position; the two ends of the second self-expanding arc 82 are connected to two adjacent fasteners 4 in a one-to-one correspondence, and the two ends of the third self-expanding arc 83 are respectively connected to the first self-expanding arc 81.

[0089] Example 2 This embodiment provides an easily adjustable anti-backflow bracket. The difference from Embodiment 1 lies in the structure of the marker 6, the fixing member 7, and the positioning member 2. The other parts of this embodiment are the same as in Embodiment 1. The following description, in conjunction with the appendix... Figures 9 to 17 A detailed explanation is provided.

[0090] The marker 6 includes a first fixing plate 62 and a central marking portion 63. The central marking portion 63 corresponds to the outer surface of the fixation member 7, facilitating observation via imaging. The central marking portion 63 and the fixing plate 72 are fitted together to increase the friction between them, thereby improving the stability of the marker 6. The first fixing plate 62 and the central marking portion 63 are connected, with a smooth transition at the connection point to reduce the risk of scratching the inner wall of the blood vessel. The first fixing plate 62 extends from one end connected to the central marking portion 63 to the other end, first fitting against the outer surface of the fixation member 7, then penetrating the fixation member 7, and then bending along the inner surface of the fixation member 7 to form a U-shaped structure, thereby positioning the central marking portion 63 on the fixation member 7. Figure 16 As shown, before installing the marker 6 and the bracket body, the first fixing plate 62 is in a flat state. During installation, the first fixing plate 62 is first made to pass through the fixing member 7. After adjusting the middle marking part 63 to fit with the fixing member 7, the first fixing plate 62 is then bent to form a shape as shown. Figure 15 and Figure 17 The state shown.

[0091] Accordingly, the fastener 7 is provided with a hole for the first fixed plate 62 to pass through. For example... Figures 9 to 15 As shown, in this embodiment, the first fixing plate 62 uses a pull wire to pass through the hole 73 and then through the fixing member 7. Figure 13 As shown, the inner wall of the draw wire through hole 73 includes a connecting surface 731 and a limiting surface 732. The connecting surface 731 is used to fit against the first fixed plate 62, and the limiting surface 732 clamps the first fixed plate 62 to prevent circumferential movement of the first fixed plate 62, thereby improving the stability of the marker 6. The limiting surface 732 and the connecting surface 731 form the inner wall of the draw wire through hole 73; the connecting surface 731 is planar, and the limiting surface 732 is arched. In some other embodiments, as an alternative, a square hole independent of the draw wire through hole 73 can be provided on the fixing member 7 for the first fixed plate 62 to pass through.

[0092] In some other embodiments, the marker 6 may be formed by a first fixed plate 62 and a central marking portion 63, but in this embodiment, the marker 6 also includes a second fixed plate 64, such as... Figure 9 , Figure 12 , Figures 14 to 17 As shown, the second fixing plate 64 and the middle marking part 63 are connected, and the two are smoothly transitioned at the connection position to reduce the risk of scratching the inner wall of the blood vessel.

[0093] like Figure 9 , Figure 12 , Figure 14 and Figure 15 As shown, the second fixing plate 64 extends from one end connected to the central marking portion 63 to the other end, first conforming to the outer surface of the fixing member 7, then penetrating through the strip hole 24 on the positioning member 2, and then bending along the surface of the positioning member 2 to form a U-shaped structure, thereby positioning the central marking portion 63 on the fixing member 7. Figure 16 As shown, before installing the marker 6 and the bracket body, the second fixing plate 64 is in a straight state. During installation, the second fixing plate 64 is first made to pass through the fixing member 7. After adjusting the middle marking part 63 to fit with the fixing member 7, the second fixing plate 64 is bent to form a shape as shown. Figure 15 , Figure 17 The state shown. In some other embodiments, as an alternative, the second fixing plate 64 can extend from one end of the connecting middle marking part 63 to the other end, first conforming to the outer surface of the fixing member 7, then penetrating the fixing member 7, and then bending along the inner surface of the fixing member 7, that is, the strip hole 24 is provided on the fixing member 7.

[0094] In this embodiment, the first fixed plate 62 is connected to the distal end of the central marking part 63, and the second fixed plate 64 is connected to the proximal end of the central marking part 63; the first fixed plate 62 and the second fixed plate 64 are bent in the same or opposite directions along the surface of the fixing member 7 or the positioning member 2.

[0095] In some other embodiments, the marker 6 may be formed by a first fixing plate 62, a central marking portion 63, and a second fixing plate 64. However, in this embodiment, the marker 6 also includes a first side portion 65, which partially adheres to the first side surface 74 of the fixing member 7 and partially adheres to the inner surface of the fixing member 7. That is, the first side portion 65 is bent and partially wraps around the fixing member 7. During installation, after adjusting the central marking portion 63 to adhere to the fixing member 7 and the first side portion 65 to adhere to the first side surface 74, the first side portion 65 is controlled to bend along the surface of the fixing member 7 so that it adheres to the inner surface of the fixing member 7.

[0096] In some other embodiments, the marker 6 may be composed of a first fixing plate 62, a central marking portion 63, a second fixing plate 64, and a first side portion 65. However, in this embodiment, the marker 6 also includes a second side portion 66, which partially adheres to the second side surface 75 of the fixing member 7 and partially adheres to the inner surface of the fixing member 7. During installation, after adjusting the central marking portion 63 to adhere to the fixing member 7 and the second side portion 66 to adhere to the second side surface 75, the second side portion 66 is controlled to bend along the surface of the fixing member 7 so that it adheres to the inner surface of the fixing member 7.

[0097] like Figure 15 , Figure 17 As shown, in this embodiment, one end of the first side portion 65 and one end of the second side portion 66 are disposed opposite each other, with a gap between them. In other embodiments, as an alternative, one end of the first side portion 65 and one end of the second side portion 66 may be fitted together or overlapped.

[0098] like Figure 15 , Figure 17 As shown, in this embodiment, there is a distance between the other end of the first fixed plate 62 and the other end of the second fixed plate 64 to make way for the first side portion 65 and the second side portion 66. In other embodiments, as an alternative, there may be a distance between one end of the first side portion 65 and one end of the second side portion 66 to make way for the first fixed plate 62 and the second fixed plate 64.

[0099] It should be noted that: (1) The marker 6 in this embodiment can also be understood as the addition of a first fixed plate 62 and a second fixed plate 64 to the C-type of embodiment 1. In other words, the middle marking position 61 of embodiment 1 and its relationship with the fixing member 7 are equivalent to the middle marking part 63 of this embodiment and its relationship with the fixing member 7. The parts on both sides of the middle marking position 61 in embodiment 1 and their relationship with the fixing member 7 are equivalent to the first side part 65 and the second side part 66 of this embodiment and their relationship with the fixing member 7.

[0100] (2) The only difference between the fastener 7 in this embodiment and that in embodiment 1 is the structure of the wire passing through the hole 73.

[0101] (3) The only difference between the positioning element 2 in this embodiment and that in embodiment 1 is that the positioning element 2 in this embodiment has a strip hole 24.

[0102] The other parts of this embodiment are the same as in Embodiment 1, and will not be repeated here.

[0103] Example 3 The difference between this embodiment and Embodiment 1 is that the adjustable anti-backflow support in this embodiment does not have auxiliary component 3, such as... Figure 18 As shown. The other parts of this embodiment are the same as in Embodiment 1, and will not be described again here.

[0104] Example 4 The difference between this embodiment and embodiment 2 is that the adjustable anti-backflow support in this embodiment does not have auxiliary component 3. The other parts of this embodiment are the same as in embodiment 2, and will not be repeated here.

[0105] Example 5 This invention also provides an artificial valve device, which includes an adjustable anti-regurgitation stent and a pull wire provided in any of the above embodiments. The adjustable anti-regurgitation stent forms an installation channel, and the pull wire is configured to pass through a pull wire through hole 73.

[0106] In this embodiment, each positioning element 2 corresponds to a pull wire, and each positioning element 2 is individually controlled by the pull wire. In some other embodiments, as an alternative, an easily adjustable anti-backflow bracket controls the extension degree of multiple positioning elements 2 by a single pull wire.

[0107] The artificial valve device also includes a diaphragm, artificial valve leaflets, and a leak-proof skirt. The diaphragm is fixed to the fastener 4 and surrounds the inside of the adjustable anti-regurgitation stent to prevent blood from leaking through the perforated areas of the adjustable anti-regurgitation stent. The artificial valve leaflets are fixed to the diaphragm, and the distal ends of the artificial valve leaflets are further fixed to the suture portion 13 of the connector 1. That is, the edges of the distal ends of the artificial valve leaflets are directly sutured through the elongated suture holes 131 without the need for additional suture pads. Compared with the traditional method of using pads and the regurgitation stent to compress the artificial valve leaflets, this method firstly reduces the additional components of the adjustable anti-regurgitation stent, and secondly, the absence of pads facilitates further compression of the adjustable anti-regurgitation stent. If there are pads, not only will the stent compression be affected, but sometimes the artificial valve leaflets may even be damaged when the stent compression size is small. The leak-proof skirt is located at the proximal end of the locking end 5 to prevent lateral leakage of the adjustable anti-regurgitation stent.

[0108] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. An easily adjustable anti-backflow support, characterized in that, include: Connectors, each of the connectors being spaced apart circumferentially along the proximal end of the adjustable anti-backflow support; The positioning element and fastener are provided between adjacent connecting elements. The positioning element and the fastener are respectively bent toward the proximal end of the adjustable anti-backflow stent. In the extended state, in the radial direction of the adjustable anti-backflow stent, the proximal end of the positioning element is located outside its corresponding fastener, and a clamping space for clamping the original leaflet is formed between the positioning element and the fastener. The positioning element includes a first positioning arm, a second positioning arm, and a proximal end of the positioning element. The first positioning arm and the second positioning arm are connected through the proximal end of the positioning element. A fixing member is connected to the proximal end of the positioning member. The proximal end of the fixing member is connected to the proximal end of the positioning member. The fixing member is provided with a pull wire through hole for the pull wire to pass through, so as to adjust the extension degree of the positioning member. The fixing member includes a fixing plate and a limiting part. The two ends of the fixing plate are respectively connected to the positioning member and the limiting part. At the connection between the fixing plate and the limiting part, the surface of the limiting part protrudes at least partially from the surface of the fixing plate. The pull wire through hole is provided on the limiting part. A marker is connected to the fixing member, and the pull wire passes through the hole, at least partially exposed through the marker, and the marker is at least partially located on the fixing plate; The marker is positioned between the proximal and distal ends of the fixing member; The locking end is located at the proximal end of the fastener, and the easily adjustable anti-backflow bracket is anchored in the installation environment through the locking end.

2. The easily adjustable anti-backflow support as described in claim 1, characterized in that, The marking member includes a first fixed plate and a central marking portion. The central marking portion corresponds to the outer surface of the fixing member. The first fixed plate extends from one end connected to the central marking portion to the other end, first adhering to the outer surface of the fixing member, then penetrating the fixing member, and then bending along the inner surface of the fixing member.

3. The easily adjustable anti-backflow support as described in claim 2, characterized in that, The marking element further includes a second fixing plate, which extends from one end connected to the central marking part to the other end, first adhering to the outer surface of the fixing element, then penetrating the fixing element, and then bending along the inner surface of the fixing element; or it first adheres to the outer surface of the fixing element, then penetrating the positioning element, and then bending along the surface of the positioning element.

4. The easily adjustable anti-backflow support as described in claim 3, characterized in that, The first fixing plate is connected to the distal end of the central marking portion, and the second fixing plate is connected to the proximal end of the central marking portion; The first fixing plate and the second fixing plate are bent in the same or opposite directions along the surface of the fixing member or the positioning member.

5. The easily adjustable anti-backflow support as described in claim 2, characterized in that, The marking element further includes a first side portion, which partially conforms to the first side surface of the fixing element and partially conforms to the inner surface of the fixing element; The marking element also includes a second side portion, which partially conforms to the second side surface of the fixing element and partially conforms to the inner surface of the fixing element.

6. The easily adjustable anti-backflow support as described in claim 2, characterized in that, The first fixed plate passes through the pull wire through the hole; The inner wall of the hole through which the pull wire passes includes a connecting surface and a limiting surface. The connecting surface is used to fit against the first fixed plate, and the limiting surface clamps the first fixed plate to prevent the first fixed plate from shifting in the circumferential direction. The limiting surface and the connecting surface form the inner wall of the wire through hole; The limiting surface is arched.

7. The easily adjustable anti-backflow support as described in claim 1, characterized in that, The adjustable anti-reflux stent further includes an auxiliary component, at least one of the positioning components is provided with the auxiliary component, and the two ends of the auxiliary component are respectively connected to the first positioning arm and the second positioning arm; one or more openings are formed between the two ends of the auxiliary component facing the proximal end of the adjustable anti-reflux stent in a V-shape; the outer surface of the V-shape auxiliary component is used to conform to the inner wall of the blood vessel. The V-shaped auxiliary part includes a first auxiliary arm, a second auxiliary arm, and a distal end of the auxiliary part, wherein the first auxiliary arm and the second auxiliary arm are connected through the distal end of the auxiliary part; When the adjustable anti-backflow support is in the extended state, the distal end of the first auxiliary arm bends toward the direction of its corresponding second auxiliary arm; The distal end of the second auxiliary arm bends toward its corresponding first auxiliary arm, and the proximal end of the first auxiliary arm bends toward a direction away from its corresponding second auxiliary arm; the proximal end of the second auxiliary arm bends toward a direction away from its corresponding first auxiliary arm. The auxiliary component has multiple V-shaped auxiliary parts arranged circumferentially, with the proximal end of the V-shaped auxiliary part closest to the first positioning arm located in the middle of the first positioning arm. In the axial direction of the easily adjustable anti-backflow bracket, the distal end of the V-shaped auxiliary part in the contracted state is flush with or lower than the distal end of the positioning member, while in the extended state, the distal end of the V-shaped auxiliary part is higher than the distal end of the positioning member.

8. The easily adjustable anti-backflow support as described in claim 1, characterized in that, The fastener includes a first fastening arm, a second fastening arm, and a fastener proximal end connecting the first fastening arm and the second fastening arm. The first fastening arm and the second fastening arm are respectively connected to two adjacent connectors. The connector includes a positioning member connecting part, a fastener connecting part, and a sewing part. The sewing part has a sewing through hole and is located between the positioning member connecting part and the fastener connecting part. The connector also includes a connecting block and a web plate. The connecting block is connected to the positioning member connecting part through the web plate. The width of the web plate is smaller than the width of the connecting block.

9. The easily adjustable anti-backflow support as described in claim 1, characterized in that, The locking end includes a plurality of locking end structural units, which are sequentially connected and form a hollow structure; the locking end structural unit includes a first locking unit facing the proximal end of the fastener and connected thereto, and a second locking unit located between adjacent first locking units; The positioning end structural unit includes a first connecting rod, a second connecting rod, a third connecting rod, and a fourth connecting rod that are connected and enclosed in sequence. The connection between the first connecting rod and the fourth connecting rod forms the distal end of the positioning end structural unit, and the connection between the second connecting rod and the third connecting rod forms the proximal end of the positioning end structural unit. When the easily adjustable anti-backflow support is in its extended state: the distal ends of the first connecting rod and the fourth connecting rod bend towards each other, the proximal ends of the second connecting rod and the third connecting rod bend towards each other, the proximal ends of the first connecting rod and the fourth connecting rod bend away from each other, and the distal ends of the second connecting rod and the third connecting rod bend away from each other.

10. The easily adjustable anti-backflow support as described in claim 1, characterized in that, The adjustable anti-backflow bracket also includes a reinforcing mesh disposed between adjacent fasteners, the proximal end of the reinforcing mesh being connected to the distal end of the locking end; The reinforcing mesh includes a first self-expanding arc, with two adjacent fasteners connected to each end of the first self-expanding arc, and the locking end connected to the middle of the first self-expanding arc. The reinforcing mesh also includes a second self-expanding arc and a third self-expanding arc, the second self-expanding arc and its corresponding third self-expanding arc being distributed along the axial direction of the adjustable anti-backflow support, or along the circumferential direction of the adjustable anti-backflow support.

11. The easily adjustable anti-backflow support as described in any one of claims 1-10, characterized in that: There are three connectors; The connectors are evenly distributed along the circumference of the easily adjustable anti-backflow bracket; Each of the aforementioned positioning components is provided with a fixing component; In the axial direction of the easily adjustable anti-backflow bracket, the distance between the proximal end of the positioning member and the proximal end of the locking end is between 4mm and 8mm. When the adjustable anti-backflow support is in the extended state: the positioning member gradually extends from its distal end to its proximal end in a direction away from the axis of the adjustable anti-backflow support, and the opening angle of the positioning member relative to the axis is between 2° and 14°; the locking end gradually extends from its distal end to its proximal end in a direction away from the axis, and the outward expansion angle of the locking end relative to the axis is between 6° and 14°. The connector, the positioning component, the fixing component, the fastener, and the locking end are integrally formed.

12. An artificial valve device, characterized in that, include: The adjustable anti-backflow support as described in any one of claims 1-10; A pull wire passes through a pull wire through hole, and one pull wire controls the degree of extension of one or more of the positioning elements.

13. The artificial valve device as described in claim 12, characterized in that, Also includes: The film is applied and fixed to the fastener; Artificial leaflets, fixed to the membrane and the connector, are used to control the opening and closing of the installation channel of the easily adjustable anti-backflow support; A leak-proof skirt is provided at the locking end to prevent side leakage of the easily adjustable anti-backflow bracket.

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