Bioprosthetic valve replacement and bioprosthetic valve system

Abstract

The application relates to a biological valve replacement and a biological valve system. The biological valve replacement comprises a cylindrical valve leaf and a support assembly. The cylindrical valve leaf comprises a first end, a second end and a channel passing through the first end and the second end, the channel comprising an opening arranged at the second end, the first end comprising a plurality of overlapping portions, the cylindrical valve leaf being capable of transforming between a first state and a second state, in the first state, the overlapping portions overlap with each other to close the channel, in the second state, the overlapping portions are separated from each other to open the channel. The support assembly comprises a plurality of support strips, the support strips being connected to the outer wall of the cylindrical valve leaf, and the plurality of support strips are uniformly and spacedly arranged around the outer wall of the cylindrical valve leaf in the circumferential direction of the cylindrical valve leaf. Wherein, the overlapping portions are arranged between adjacent support strips. The application can increase the effective valve orifice area and reduce the transvalvular pressure difference.

Description

Technical Field

[0001] This application relates to the field of bioprosthetic valve technology, and in particular to a bioprosthetic valve replacement material and a bioprosthetic valve system. Background Technology

[0002] In the clinical treatment of valvular heart disease, stent bioprosthetic valves are currently the most widely used treatment devices, and their related technologies have matured, occupying an important position in clinical applications. These stent bioprosthetic valves achieve valve function through their inherent structure, and their standardized size design adapts to the annular sizes of most adult patients, providing an effective solution for minimally invasive treatment of valvular heart disease.

[0003] However, the rigid stents of existing bioprosthetic valves occupy part of the space inside the valve annulus, resulting in a relatively small effective opening area, often producing a high transvalvular pressure gradient, and poor long-term performance. Summary of the Invention

[0004] This application provides a biological valve replacement material and a biological valve system that can increase the effective valve orifice area and reduce transvalvular pressure gradient.

[0005] This application provides a biological valve replacement device, comprising a cylindrical leaflet and a support assembly. The cylindrical leaflet includes a first end, a second end, and a channel penetrating both ends. The channel includes an opening at the second end. The first end includes multiple overlapping portions. The cylindrical leaflet is capable of switching between a first state and a second state. In the first state, the overlapping portions overlap to close the channel; in the second state, the overlapping portions separate to open the channel. The support assembly includes multiple support strips connected to the outer wall of the cylindrical leaflet. The support strips are evenly spaced around the outer wall of the cylindrical leaflet along its circumference. Overlapping portions are provided between adjacent support strips.

[0006] The bioprosthetic valve replacement device of this application embodiment realizes the opening and closing of the channel through the overlapping part of the cylindrical valve leaflet, and is equipped with support strips evenly spaced in the circumferential direction, with overlapping parts between adjacent support strips. The support strips are the junction points of the overlapping parts and the force points when the overlapping parts are closed. This can ensure the flexibility and sealing of the opening and closing of the cylindrical valve leaflet, and can also form stable support for the cylindrical valve leaflet through the support components.

[0007] In some feasible ways, one end of the support bar extends beyond the first end.

[0008] By setting a support strip with one end extending beyond the first end of the tubular leaflet, the space occupied by the valve annulus is reduced while providing support for the tubular leaflet, thereby increasing the effective valve orifice area, improving hemodynamic performance, and thus reducing transvalvular pressure gradient.

[0009] In some feasible implementations, the support assembly includes two support bars, the first end of which includes two overlapping portions, the support bars and overlapping portions being alternately arranged circumferentially along the cylindrical leaflet.

[0010] By setting the support component as two support bars and two overlapping parts, and alternating the two support bars and two overlapping parts along the circumference of the tubular leaflet, the structural design of the support component can be simplified, the manufacturing difficulty and cost can be reduced, while ensuring the support stability of the support bars on the tubular leaflet and the opening and closing flexibility of the overlapping parts, making the overall structure of the bioprosthetic valve replacement more compact, adaptable to small-sized valve annulus, and further improving the convenience of implantation and the reliability of use.

[0011] In some feasible implementations, the support assembly includes three support bars, with three overlapping portions at the first end, the support bars and overlapping portions being alternately arranged circumferentially along the cylindrical leaflet.

[0012] By configuring the support assembly with three support bars and three overlapping sections, and arranging these three support bars and three overlapping sections alternately along the circumference of the tubular valve leaflet, the stability and uniformity of the support assembly's support for the tubular valve leaflet can be further improved, reducing the possibility of displacement or deformation of the tubular valve leaflet during opening and closing. At the same time, the distribution of the overlapping sections is more rational, ensuring a tight seal when the channel is closed and smoothness when it is opened, thus improving the long-term effectiveness of the bioprosthetic valve replacement.

[0013] In some feasible ways, the length of the support bar extending beyond the first end is less than or equal to one time the diameter of the cylindrical leaflet.

[0014] By setting the length of the support bar extending beyond the first end to be less than or equal to one times the diameter of the tubular leaflet, this length design ensures that the support bar provides effective support for the tubular leaflet, balancing support stability and implantation fit, and further reducing the surgical risks associated with valve implantation.

[0015] In some feasible implementations, the support bar includes a first connecting portion that is connected to the outer wall of the cylindrical leaflet.

[0016] By setting a first connecting part, and connecting the first connecting part to the outer wall of the cylindrical leaflet, the support force is transmitted more evenly, reducing the possibility of stress concentration at the connection between the support bar and the cylindrical leaflet, which could lead to damage to the cylindrical leaflet.

[0017] In some feasible implementations, the support bar also includes a second connection portion along the radial direction of the tubular leaflet, the second connection portion being connected to the outer wall of the first connection portion facing away from the tubular leaflet, the second connection portion being configured to connect to the vessel wall.

[0018] By setting a second connecting part, which is connected to the outer wall of the first connecting part facing away from the cylindrical leaflet and used to connect with the blood vessel wall, the connection between the first connecting part and the second connecting part can make the connection between the support strip and the cylindrical leaflet and the blood vessel wall more secure, improve the fixation stability of the bioprosthetic valve replacement after implantation, reduce the risk of displacement, and improve the stability of long-term use.

[0019] In some feasible implementations, the width of the second connector along the radial direction of the tubular valve leaflet is less than or equal to 1 cm. By limiting the width of the second connector along the radial direction of the tubular valve leaflet to less than or equal to 1 cm, this sufficient width increases the contact area between the second connector and the vessel wall, reduces the pressure at the contact site, and decreases the possibility of damage to the vessel wall due to excessive local pressure. Simultaneously, it improves the connection stability between the support strip and the vessel wall, further reducing the possibility of loosening or displacement of the bioprosthetic valve replacement after implantation, thus enhancing its safety and reliability.

[0020] In some feasible implementations, the end faces of the first end and the second end are planar or wavy surfaces.

[0021] By designing the end faces of both the first and second ends of the tubular leaflet as wavy surfaces, the wavy surfaces increase the toughness and adaptability of the leaflet end faces, reducing the possibility of tearing or abrasion during opening and closing, and extending the lifespan of the leaflet. Simultaneously, the wavy structure better conforms to the physiological morphology of the blood vessel wall and valve annulus, reducing irritation to surrounding tissues and improving post-implantation compatibility.

[0022] This application provides a bioprosthetic valve system, which includes a bioprosthetic valve replacement and a bioprosthetic pad strip. The bioprosthetic pad strip is configured to connect to a second end of the bioprosthetic valve replacement, so that the bioprosthetic pad strip and the second end clamp and fix the valve annulus.

[0023] The bioprosthetic valve system of this application embodiment, by setting up a bioprosthetic valve replacement and a bioprosthetic pad, with the bioprosthetic pad and bioprosthetic valve replacement working together to fix the valve annulus, enhances the fixation effect after implantation and reduces the risk of bioprosthetic valve replacement displacement and leakage. At the same time, the bioprosthetic pad can buffer the force between the bioprosthetic valve replacement and the valve annulus, reducing damage to the valve annulus, further adapting to children and patients with small valve annulus, preserving the development space of the valve annulus, and improving the long-term effectiveness and safety of surgical treatment.

[0024] In some feasible implementations, the bio-pad strip includes multiple suture units spaced apart along the length of the bio-pad strip, the length of which is the same as the circumferential direction of the tubular leaflet.

[0025] By setting the bio-pad strip into multiple suture units spaced apart along the length of the bio-pad strip, the suture units facilitate segmented suturing of the bio-pad strip and valve annulus during surgery, improving the convenience and precision of suturing. At the same time, it makes the fixation force after suturing more uniform, reducing the possibility of valve annulus damage due to excessively tight suturing or displacement of bio-valve replacement due to excessively loose suturing, and further reducing surgical risks.

[0026] In some feasible implementations, the bio-pad strip includes a breakable connector, through which adjacent suture units are connected.

[0027] By incorporating breakable connectors between adjacent suture units, the bioprosthetic pad maintains its integral structure preoperatively, facilitating intraoperative positioning and manipulation. During surgery, excess suture units can be broken according to the actual size of the valve annulus and suture requirements, ensuring the bioprosthetic pad length matches the valve annulus specifications. Furthermore, the breakable connectors spontaneously break off postoperatively as the valve annulus grows, without restricting its development. This caters to the individual needs of children and patients with small valve annulus, improving the adaptability and surgical outcomes of the bioprosthetic valve system. Attached Figure Description

[0028] The features, advantages, and technical effects of exemplary embodiments of this application will now be described with reference to the accompanying drawings.

[0029] Figure 1 This is a schematic diagram of the structure of the cylindrical leaflet in the first state according to some embodiments of this application; Figure 2 A schematic diagram of the structure of the cylindrical leaflet in the second state provided in some embodiments of this application, viewed from a first perspective. Figure 3 A schematic diagram of the structure of the cylindrical leaflet in the second state, provided in some embodiments of this application, from a second perspective. Figure 4 for Figure 3 Enlarged diagram of A in the middle; Figure 5 This is a schematic diagram of the assembled structure of the bio-valve replacement material and bio-pad strip provided in some embodiments of this application.

[0030] The accompanying drawings are not necessarily drawn to scale.

[0031] Explanation of reference numerals in the attached figures: 1. Tubular leaflet; 11. First end; 111. Overlap; 12. Second end; 121. Opening; 13. Channel; 2. Support component; 21. Support bar; 211. First connecting part; 212. Second connecting part; 3. Biological pad strip; 31. Suture unit; 32. Breakable connector; S1, The length of the support bar extends beyond the first end; S2, the width of the second connecting part. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0033] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used in the description of this application is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms "comprising" and "having," and any variations thereof, in the description, claims, and accompanying drawings of this application are intended to cover non-exclusive inclusion. The terms "first," "second," etc., in the description, claims, or accompanying drawings of this application are used to distinguish different objects, not to describe a specific order or hierarchy.

[0034] In this application, the reference to "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment that is mutually exclusive with other embodiments.

[0035] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "attachment" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0036] In the embodiments of this application, the same reference numerals denote the same components, and for the sake of brevity, detailed descriptions of the same components are omitted in different embodiments. It should be understood that the thickness, length, width, and other dimensions of various components in the embodiments of this application shown in the accompanying drawings, as well as the overall thickness, length, width, and other dimensions of the integrated device, are merely illustrative and should not constitute any limitation on this application.

[0037] In this application, "multiple" means two or more (including two).

[0038] like Figures 1 to 4 As shown in the figure, this application provides a biological valve replacement device, which includes a cylindrical valve leaflet 1 and a support assembly 2.

[0039] The cylindrical leaflet 1 includes a first end 11, a second end 12, and a channel 13 penetrating the first end 11 and the second end 12. The channel 13 includes an opening 121 at the second end 12. The first end 11 includes multiple overlapping portions 111. The cylindrical leaflet 1 can switch between a first state and a second state. In the first state, the overlapping portions 111 overlap each other to close the channel 13. In the second state, the overlapping portions 111 separate each other to open the channel 13. The support assembly 2 includes multiple support bars 21. The support bars 21 are connected to the outer wall of the cylindrical leaflet 1. Along the circumference of the cylindrical leaflet 1, the multiple support bars 21 are evenly spaced around the outer wall of the cylindrical leaflet 1. Among them, overlapping portions 111 are provided between adjacent support bars 21.

[0040] In some feasible methods, the bioprosthetic valve replacement is inserted entirely into the patient's target valve annulus, with the second end 12 of the tubular leaflet 1 facing the valve annulus. Multiple support strips 21 of the support assembly 2 are attached to the outer wall of the tubular leaflet 1 and spread circumferentially along the valve annulus, providing stable support to the valve annulus and surrounding tissues, thus completing the implantation and positioning of the bioprosthetic valve replacement. After implantation, when blood flows towards the channel 13 of the tubular leaflet 1, the blood pushes the multiple overlapping portions 111 of the first end 11 of the tubular leaflet 1 to separate, causing the tubular leaflet 1 to change to a second state, opening the channel 13 and allowing blood to pass smoothly through the channel 13 and the opening 121 of the second end 12. When blood tends to flow back, the backflow force causes the multiple overlapping portions 111 of the first end 11 of the tubular leaflet 1 to overlap, changing the tubular leaflet 1 to a first state, closing the channel 13, thereby preventing blood backflow.

[0041] The bioprosthetic valve replacement device of this application embodiment realizes the opening and closing of the channel 13 through the overlapping portion 111 of the cylindrical valve leaflet 1. The overlapping portion 111 is provided between the circumferentially evenly spaced support strips 21 and adjacent support strips 21. The support strips 21 are the junction points of the overlapping portions 111 and the force points when the overlapping portions 111 are closed. This can ensure the flexibility and sealing of the opening and closing of the cylindrical valve leaflet 1, and can also form a stable support for the cylindrical valve leaflet 1 through the support component 2.

[0042] In some feasible ways, the cylindrical leaflet 1 can be made of expanded polytetrafluoroethylene material, but is not limited to.

[0043] In some feasible ways, one end of the support bar 21 extends beyond the first end 11.

[0044] By setting a support bar 21 with one end of the support bar 21 extending beyond the first end 11 of the tubular leaflet 1, the support bar 21 provides support for the tubular leaflet 1 while reducing the occupation of the internal space of the valve annulus, increasing the effective valve orifice area, improving hemodynamic performance, and thus reducing the possibility of transvalvular pressure gradient.

[0045] In this embodiment, the flexible support strip 21 undergoes slight deformation under external force, and can adapt to slight deformation as the tubular leaflet 1 opens and closes. Simultaneously, the flexible support strip 21 itself provides support, thus offering stable support for the tubular leaflet 1. The flexible support strip 21 neither restricts the separation and overlap of the overlapping portion 111 of the tubular leaflet 1, nor restricts the physiological morphology of the blood vessel wall and the outer wall of the tubular leaflet 1 to reduce tissue irritation, while also possessing sufficient support to provide a stable point of application for the overlapping portion 111 of the tubular leaflet 1 and assist in the smooth opening and closing of the valve.

[0046] In some examples, the support bar 21 may be, but is not limited to, made of pericardium material.

[0047] In some feasible ways, such as Figure 2 As shown, the support component 2 includes two support bars 21, and the first end 11 includes two overlapping portions 111. The support bars 21 and the overlapping portions 111 are alternately arranged along the circumference of the cylindrical leaf 1.

[0048] By setting the support component 2 as two support bars 21 and the first end 11 as two overlapping parts 111, and the two support bars 21 and the two overlapping parts 111 are alternately arranged along the circumference of the cylindrical leaflet 1, the structural design of the support component 2 can be simplified, the manufacturing difficulty and cost can be reduced, and the support stability of the support bars 21 on the cylindrical leaflet 1 and the opening and closing flexibility of the overlapping parts 111 can be ensured. This makes the overall structure of the bioprosthetic valve replacement more compact, adaptable to small-sized valve annulus, and further improves the convenience of implantation and the reliability of use.

[0049] In some feasible implementations, after implantation, the two support strips 21 provide symmetrical support for the tubular leaflet 1. When blood flows in the forward direction, the two overlapping portions 111 separate, allowing the tubular leaflet 1 to open the channel 13; when blood flows backward, the two overlapping portions 111 overlap, allowing the tubular leaflet 1 to close the channel 13. This support assembly 2 and the first end 11 have a simple structure and occupy little space, providing basic and stable support for the tubular leaflet 1, ensuring the normal opening and closing of the tubular leaflet 1, and are suitable for implantation environments with high requirements for structural dimensions.

[0050] In some feasible ways, a bioprosthetic valve replacement including two support bars 21 and two overlaps 111 can be used, but is not limited to, for mitral, tricuspid, aortic, or pulmonary valve positions.

[0051] In some possible implementations, the support assembly 2 includes three support bars 21, and the first end 11 includes three overlapping portions 111, with the support bars 21 and overlapping portions 111 alternately arranged circumferentially along the cylindrical leaflet 1.

[0052] By configuring the support component 2 as three support bars 21 and the first end 11 as three overlapping portions 111, with the three support bars 21 and the three overlapping portions 111 alternately arranged along the circumference of the cylindrical valve leaflet 1, the support stability and uniformity of the support component 2 on the cylindrical valve leaflet 1 can be further improved, reducing the possibility of the cylindrical valve leaflet 1 shifting or deforming during opening and closing. At the same time, the distribution of the overlapping portions 111 is more reasonable, ensuring the sealing of the channel 13 when closed and its smoothness when opened, thus improving the long-term effectiveness of the bioprosthetic valve replacement.

[0053] In some feasible implementations, after implantation, the three support strips 21 are evenly distributed circumferentially, providing balanced and stable support for the tubular valve leaflet 1. During forward blood flow, the three overlapping portions 111 separate, allowing the channel 13 to open more smoothly; during reverse blood flow, the three overlapping portions 111 overlap, making the channel 13 close more tightly. Compared to a structure with two support strips 21 and two overlapping portions 111, this structure offers higher support strength, more uniform stress distribution, better opening and closing stability and sealing effect of the tubular valve leaflet 1, and higher long-term operational reliability.

[0054] In some feasible ways, a bioprosthetic valve replacement including three support bars 21 and three overlapping portions 111 can be used, but is not limited to, for aortic valve or pulmonary valve positions.

[0055] In some feasible ways, such as Figure 2 and Figure 5 As shown, the length S1 of the support bar 21 extending beyond the first end is less than or equal to one time the diameter of the cylindrical leaflet 1.

[0056] By limiting the length of the support strip 21 beyond the first end 11 of the tubular leaflet 1 to less than or equal to one time the diameter of the tubular leaflet 1, this length design ensures that the support strip 21 provides effective support for the tubular leaflet 1, reducing the possibility of implantation difficulties or interference with surrounding vascular tissue due to excessive length of the support strip 21. This balances support stability and implantation compatibility, further reducing the surgical risks associated with valve implantation.

[0057] In some feasible ways, the length of the support bar 21 extending beyond the first end 11 can be trimmed as needed.

[0058] In some feasible ways, the length S1 of the support bar 21 extending beyond the first end is 0.5 times, 0.7 times, 0.8 times, or 1.0 times the diameter of the cylindrical leaflet 1.

[0059] In some feasible embodiments, when the bioprosthetic valve replacement is used in the aortic or pulmonary valve position, the support strip 21 may not extend beyond the first end 11. When the bioprosthetic valve replacement is used in the mitral or tricuspid valve position, the support strip 21 extends beyond the first end 11.

[0060] In some feasible ways, such as Figures 1 to 4 As shown, the support bar 21 includes a first connecting part 211, which is connected to the outer wall of the cylindrical leaflet 1.

[0061] By setting the first connecting part 211 and connecting the first connecting part 211 to the outer wall of the cylindrical leaflet 1, the support force is transmitted more evenly, reducing the possibility of stress concentration at the connection between the support bar 21 and the cylindrical leaflet 1, which could lead to damage to the cylindrical leaflet 1.

[0062] In some feasible ways, during the surgical suturing process, the first connecting part 211 of the support strip 21 fits against the outer wall of the tubular leaflet 1 and is fixedly connected to the outer wall of the tubular leaflet 1, thereby achieving a stable assembly between the support strip 21 and the tubular leaflet 1.

[0063] In some examples, the first connecting portion 211 may be connected to the outer wall of the cylindrical leaflet 1 by means of stitching, but not limited to stitching.

[0064] In some possible implementations, the thickness of the first connecting portion 211 may be, but is not limited to, 1 mm, and the width of the first connecting portion 211 may be from 2 mm to 5 mm. For example, the width of the first connecting portion 211 may be 2 mm, 3 mm, 4 mm, 5 mm, or a range of any two of these values. The thickness of the first connecting portion 211 refers to the dimension measured radially along the cylindrical leaflet 1, and the width of the first connecting portion 211 refers to the dimension measured circumferentially along the cylindrical leaflet 1.

[0065] In some possible implementations, the support bar 21 further includes a second connection 212 along the radial direction of the tubular leaflet 1, the second connection 212 being connected to the outer wall of the first connection 211 facing away from the tubular leaflet 1, and the second connection 212 being configured to connect to the blood vessel wall.

[0066] By providing a second connecting part 212, which is connected to the outer wall of the first connecting part 211 facing away from the cylindrical leaflet 1 and used to connect with the blood vessel wall, the connection between the first connecting part 211 and the second connecting part 212 can make the connection between the support strip 21 and the cylindrical leaflet 1 and the blood vessel wall more secure, improve the fixation stability after implantation of the bioprosthetic valve replacement, reduce the risk of displacement, and improve the stability of long-term use.

[0067] In some feasible ways, during surgical suturing, the second connector 212 unfolds toward and adheres to the vessel wall and is fixedly connected to the vessel wall, thereby fixing the bioprosthetic valve replacement in the target position.

[0068] In some examples, the second connection 212 may be connected to the blood vessel wall by means of suturing, but not limited to suturing.

[0069] In some feasible ways, such as Figure 4 As shown, along the radial direction of the cylindrical leaflet 1, the width S2 of the second connecting part is less than or equal to 1 cm.

[0070] In some feasible methods, during surgical implantation, the second connecting part 212 can be trimmed and adjusted according to the actual suture position and fitting size of the blood vessel wall. Along the radial direction of the cylindrical valve leaflet 1, the width S2 of the second connecting part is less than or equal to 1 cm. This width range can meet the needs of the trimming operation. The width of the second connecting part 212 can be trimmed to a suitable size according to the actual suture position, so that the trimmed second connecting part 212 can fully fit the suture area of ​​the corresponding blood vessel wall. This ensures that the second connecting part 212 and the blood vessel wall have sufficient contact area for suture fixation, while reducing the pressure on the surrounding tissue caused by the excessive size of the second connecting part 212, thereby improving the stability and fit of the connection between the support strip 21 and the blood vessel wall.

[0071] In some examples, when the bioprosthetic valve replacement is used in the mitral or tricuspid valve position, the second connecting portion 212 may not be provided. When the bioprosthetic valve replacement is used in the aortic or pulmonary valve position, the second connecting portion 212 is provided.

[0072] In some feasible implementations, the width S2 of the second connection is 0.2 cm, 0.5 cm, 0.8 cm, 1 cm, or a range of any two of these values.

[0073] In some feasible implementations, the thickness of the second connecting portion 212 can be from 1 mm to 3 mm. For example, the thickness of the second connecting portion 212 can be 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, or a range of any two of these values. The thickness of the second connecting portion 212 refers to the dimension measured radially along the cylindrical leaflet 1.

[0074] In some feasible ways, such as Figure 5 As shown, the end face of the first end 11 and the end face of the second end 12 are either flat or wavy surfaces.

[0075] By designing the end faces of the first end 11 and the second end 12 of the tubular leaflet 1 as alternating wavy surfaces, the wavy surfaces can increase the toughness and adaptability of the end faces of the tubular leaflet 1, reduce the possibility of tearing or wear of the end faces during opening and closing, and extend the service life of the tubular leaflet 1. At the same time, the wavy structure can better conform to the physiological morphology of the blood vessel wall and valve annulus, reduce stimulation to surrounding tissues, and improve post-implantation compatibility.

[0076] This application provides a biological valve system, such as Figure 5 As shown, it includes a bioprosthetic valve replacement and a bioprosthetic pad strip 3. The bioprosthetic pad strip 3 is configured to connect to the second end 12 of the bioprosthetic valve replacement, so that the bioprosthetic pad strip 3 and the second end 12 clamp and fix the valve annulus.

[0077] In some feasible ways, the valve ring is autologous biological tissue.

[0078] In some feasible configurations, the second end 12 of the bioprosthetic valve replacement, the valve annulus, and the bioprosthetic pad strip 3 are sequentially connected along the radial direction of the opening 121 of the second end 12.

[0079] In some feasible methods, during surgical implantation, the bioprosthetic valve replacement is first placed into the target valve annulus region, and then the bioprosthetic pad 3 is placed on the outside of the valve annulus. The bioprosthetic pad 3, the valve annulus, and the second end 12 of the bioprosthetic valve replacement are simultaneously sutured and fixed to achieve a stable connection between the bioprosthetic pad 3, the bioprosthetic valve replacement, and the valve annulus, thus completing the implantation and positioning of the entire bioprosthetic valve system.

[0080] The bioprosthetic valve system of this application embodiment, by setting up a bioprosthetic valve replacement and a bioprosthetic pad 3, with the bioprosthetic pad 3 and the bioprosthetic valve replacement working together to fix the valve annulus, enhances the fixation effect after implantation and reduces the possibility of bioprosthetic valve replacement displacement and leakage. Simultaneously, the bioprosthetic pad 3 can buffer the force between the bioprosthetic valve replacement and the valve annulus, reducing damage to the valve annulus, further adapting to children and patients with small valve annulus, preserving the developmental space of the valve annulus, and improving the long-term effectiveness and safety of surgical treatment.

[0081] In some feasible ways, the bio-pad strip 3 can be made of materials such as polyester fabric, polytetrafluoroethylene, and polyester resin.

[0082] In some feasible ways, such as Figure 5 As shown, the biological pad strip 3 includes multiple suture units 31, which are spaced apart along the length direction of the biological pad strip 3. The length direction of the biological pad strip 3 is the same as the circumferential direction of the cylindrical leaflet 1.

[0083] By setting the biological pad strip 3 into multiple suture units 31 spaced apart along the length of the biological pad strip 3, the suture units 31 facilitate segmented suturing of the biological pad strip 3 and the valve annulus during the operation, improving the convenience and accuracy of suturing. At the same time, it makes the fixation force after suturing more uniform, reducing the possibility of valve annulus damage due to excessively tight local suturing or displacement of biological valve replacement due to excessively loose local suturing, and further reducing the surgical risk.

[0084] In some feasible methods, multiple suture units 31 are sequentially sutured to the valve annulus along the circumference of the tubular leaflet 1. Each suture unit 31 independently completes the fixation to the valve annulus, so that the biological pad strip 3 and the valve annulus form a segmented and uniformly distributed suture structure, thereby stably connecting the biological valve replacement material to the valve annulus.

[0085] In some feasible implementations, the suture unit 31 is provided with suture points (not shown in the figure) through which it is sutured to the valve annulus.

[0086] In some feasible implementations, the biological pad strip 3 includes a breakable connector 32, through which adjacent suture units 31 are connected.

[0087] By providing a breakable connector 32 between adjacent suture units 31, the bioprosthetic pad 3 can maintain its integral structure preoperatively, facilitating intraoperative positioning and manipulation. During the operation, excess suture units 31 can be broken according to the actual size of the valve annulus and suture requirements, allowing the length of the bioprosthetic pad 3 to match the valve annulus specifications. Simultaneously, the breakable connector 32 can spontaneously break off postoperatively as the valve annulus grows, reducing the possibility of restricting valve annulus growth, thus adapting to the individual needs of children and patients with small valve annulus, and improving the adaptability and surgical outcome of the bioprosthetic valve system.

[0088] In some feasible methods, during surgical implantation, a moderate external force can be applied to the breakable connection 32 between adjacent suture units 31 on the bio-pad strip 3 according to the actual size of the valve annulus and suture requirements, causing the breakable connection 32 to break, thereby removing the excess suture unit 31, so that the length of the bio-pad strip 3 matches the size of the valve annulus, and then the connection and fixation between the bio-pad strip 3 and the valve annulus is completed through the retained suture unit 31.

[0089] As the pediatric patient's valve annulus gradually grows and expands after surgery, the slow traction force generated by the valve annulus will act on the biological pad strip 3. The breakable connection 32 between adjacent suture units 31 can break on its own under the action of growth stress, so that the constraint between adjacent suture units 31 is gradually released, providing a suitable space for the growth and development of the valve annulus and reducing the possibility of the biological valve system causing excessive restriction on the growth of the valve annulus.

[0090] In some feasible ways, the breakable connection 32 may be made of an absorbable material, but is not limited to.

[0091] In some examples, the breakable connection 32 may be made of materials such as polycaprolactone, poly(DL-lactide-glycolic acid), collagen nanofibers, or polylactic acid.

[0092] Although this application has been described with reference to preferred embodiments, various modifications can be made thereto and components can be replaced with equivalents without departing from the scope of this application. In particular, the technical features mentioned in the various embodiments can be combined in any manner, provided there is no structural conflict. This application is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A biological valve replacement material, characterized in that, include: A cylindrical leaflet includes a first end, a second end, and a channel penetrating the first end and the second end. The channel includes an opening at the second end. The first end includes multiple overlapping portions. The cylindrical leaflet is capable of switching between a first state and a second state. In the first state, the overlapping portions overlap each other to close the channel. In the second state, the overlapping portions separate each other to open the channel. A support assembly includes multiple support bars connected to the outer wall of the tubular leaflet. The multiple support bars are evenly spaced around the outer wall of the tubular leaflet along the circumference of the tubular leaflet. Each support bar includes a first connecting portion and a second connecting portion. The first connecting portion is connected to the outer wall of the tubular leaflet along the radial direction of the tubular leaflet. The second connecting portion is connected to the first connecting portion facing away from the outer wall of the tubular leaflet and is configured to connect to the blood vessel wall. The overlapping portion is provided between adjacent support bars.

2. The biological valve replacement material according to claim 1, characterized in that, One end of the support bar extends beyond the first end.

3. The biological valve replacement material according to claim 2, characterized in that, The support assembly includes two support bars, the first end of which includes two overlapping portions, and the support bars and the overlapping portions are alternately arranged along the circumference of the cylindrical leaflet.

4. The biological valve replacement material according to claim 2, characterized in that, The support assembly includes three support bars, and the first end includes three overlapping portions. The support bars and the overlapping portions are alternately arranged along the circumference of the cylindrical leaflet.

5. The biological valve replacement according to any one of claims 3 or 4, characterized in that, The length of the support bar extending beyond the first end is less than or equal to one time the diameter of the cylindrical leaflet.

6. The biological valve replacement according to any one of claims 3 or 4, characterized in that, Along the radial direction of the cylindrical leaflet, the width of the second connecting portion is less than or equal to 1 cm.

7. The biological valve replacement according to any one of claims 3 or 4, characterized in that, The end face of the first end and the end face of the second end are either flat or wavy surfaces.

8. A biological valve system, characterized in that, include: The bioprosthetic valve replacement as described in any one of claims 1 to 7, A bio-pad strip, the bio-pad strip being configured to connect to the second end of the bio-valve replacement, such that the bio-pad strip and the second end clamp and fix the valve annulus.

9. The biological valve system according to claim 8, characterized in that, The biological pad strip includes multiple suture units, which are spaced apart along the length of the biological pad strip, and the length of the biological pad strip is the same as the circumferential direction of the cylindrical leaflet.

10. The biological valve system according to claim 9, characterized in that, The biological pad strip includes a breakable connector, through which adjacent suture units are connected.

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