An artificial bioprosthetic valve stent, a pre-implantable artificial bioprosthetic valve, an implantation system and uses

Abstract

This invention discloses an artificial bioprosthetic valve stent, a pre-positionable artificial bioprosthetic valve, an implantation system, and its application. The artificial bioprosthetic valve stent may include: a valve frame, a valve seat, an anchor seat, and three anchor blocks fitted on the anchor seat; the valve frame has three leaflet supports; the valve seat is an annular metal seat, with the valve frame embedded above the valve seat and sutured to the valve seat through a covering; the anchor seat is a balloon-expandable annular metal seat, located on the side opposite to the valve frame and sutured to the valve seat through a covering; the three anchor blocks correspond to the positions of the three leaflet supports in the valve frame; the artificial bioprosthetic valve stent has a first state and a second state; in the first state, the area where the anchor blocks are located on the anchor seat is concave radially inward along the anchor seat, and the outer diameter of the circle containing the outer edges of the three anchor blocks is smaller than the outer diameter of the valve seat; in the second state, the anchor seat is annular, and the outer diameter of the circle containing the outer edges of the three anchor blocks is larger than the outer diameter of the valve seat.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an artificial bioprosthetic valve stent, a pre-positionable artificial bioprosthetic valve, an implantation system, and its applications. Background Technology

[0002] Aortic valve replacement (AVR) is the primary treatment for aortic valve disease. However, in clinical practice, the problem of aortic annular stenosis or aortic root stenosis (collectively referred to as "small aortic annulus," SAA) is becoming increasingly prominent, especially in AVR patients with congenital heart disease, rheumatic heart disease with predominantly stenotic aortic stenosis, those who are small in stature or overweight, and those with dysplasia of the aortic root (including the sinoductal commissure, annulus, and outflow tract). Due to limitations in local anatomy, these patients often cannot receive an artificial valve of sufficient diameter, leading to postoperative problems such as high transvalvular pressure gradient, poor hemodynamic improvement, and increased left ventricular afterload. This not only affects cardiac function recovery and long-term quality of life and survival rate but may also accelerate the deterioration of the bioprosthetic valve.

[0003] Small aortic annulus (SAA) is generally defined as a condition where a prosthetic valve with a diameter greater than 21 mm cannot be implanted during surgical aortic valve replacement (SAVR), or where the average diameter of the aortic annulus measured by CT during transcatheter aortic valve replacement (TAVR) is ≤23 mm. Statistics show that SAA accounts for about one-third of AVR surgeries in Europe and America, while the aortic annulus anatomy is generally smaller in Asian populations, resulting in a higher incidence of SAA, predominantly affecting female patients. After AVR, SAA patients often experience patient-prosthesis mismatch (PPM) due to the small effective orifice area (EOA) relative to the body surface area, leading to increased mortality, ischemic cardiovascular events, and stroke risk, and difficulty meeting the patient's cardiac output requirements during rest and exercise.

[0004] In surgical aortic valve replacement (SAVR), severe post-operative peripheral pulse (PPM) has been proven to be significantly associated with increased mortality. PPM is a key indicator of postoperative hemodynamics, and its potential impact on long-term prognosis remains significant. With the trend of increasingly younger patients undergoing valve intervention, reducing PPM risk and optimizing effective valve diameter design will become important directions for future device development and surgeon decision-making.

[0005] Currently, SAVR combined with aortic root enlargement is the main surgical strategy for treating small aortic valve annulus. However, this surgery is highly invasive and complex, prolonging aortic clamping and cardiopulmonary bypass time, and may lead to complications such as bleeding and valvular dysfunction. To reduce surgical trauma, sutureless or rapidly deployable valves (such as Perceval S, 3F Enable, and Intuity) are increasingly used clinically. These valves are easy to implant, shorten operation time, and have good hemodynamic performance. However, these valves still have problems such as a higher incidence of postoperative palpitations, fatigue, bradycardia, arrhythmias, and paravalvular leaks. Summary of the Invention

[0006] This invention was developed to stably anchor artificial bioprosthetic valves to save surgical time and avoid postoperative palpitations, fatigue, bradycardia, heart failure induced by bradycardia, arrhythmia, and paravalvular leakage.

[0007] As one aspect of the present invention, an embodiment of the present invention provides an artificial biological valve stent, which may include: a valve frame, a valve seat, an anchor seat, and three anchor blocks sleeved on the anchor seat;

[0008] The valve frame has three leaflet supports; the valve seat is an annular metal seat, the valve frame is embedded above the valve seat and is stitched to the valve seat through a covering; the anchor is a balloon-expandable annular metal seat, the anchor is located on the side opposite to the valve frame and is stitched to the valve seat through a covering; the three anchor blocks correspond to the positions of the three leaflet supports in the valve frame;

[0009] The artificial bio-valve stent has a first state and a second state;

[0010] In the first state, the area where the anchoring block is located is concave in the radial direction of the anchoring seat, and the outer diameter of the circle containing the outer edges of the three anchoring blocks is smaller than the outer diameter of the petal seat; in the second state, the anchoring seat is annular, and the outer diameter of the circle containing the outer edges of the three anchoring blocks is larger than the outer diameter of the petal seat.

[0011] In one embodiment, the valve seat is a unidirectional, limit-expandable annular metal seat;

[0012] In the first state, the outer diameter of the valve seat is smaller than that in the second state;

[0013] In the first state, the ratio of the outer diameter of the petal seat to the outer diameter of the anchor seat is 1.04:1 to 1.1:1;

[0014] In the second state, the ratio of the outer diameter of the petal seat to the outer diameter of the anchor seat is 1:1.

[0015] In one embodiment, the length of the anchor block along the circumferential direction of the anchor seat is 5-7 mm; the width of the anchor block along the radial direction of the anchor seat is 4-6 mm; and the height of the anchor block perpendicular to the length and width directions is 4-7 mm.

[0016] In one embodiment, along the radial direction of the anchor seat, the width of the anchor block located outside the anchor seat accounts for 15% to 20% of the total width of the anchor block.

[0017] In one embodiment, in the second state, the ratio of the outer diameter of the petal seat to the outer diameter of the circle containing the outer edges of the three anchor blocks is 1:1.1 to 1:1.3.

[0018] In one embodiment, the positions of the three anchor blocks can be adjusted within a predetermined circumferential region on the anchor seat.

[0019] In one embodiment, the petal seat is composed of several overlapping and interconnected seat units with staggered front and rear sections. The front end of each seat unit is provided with a first rivet, a limiting protrusion, and a first elongated groove from the outside to the inside. The rear end of each seat unit is provided with a second elongated groove that mates with the first rivet at the front end of the adjacent seat unit, a second limiting hole and a first limiting hole that mate with the limiting protrusion, and a second rivet that mates with the first elongated groove. The first elongated groove of each seat unit mates with the second rivet of the adjacent seat unit and can move in one direction. The second elongated groove of each seat unit mates with the first rivet of the adjacent seat unit and can move in one direction. The limiting protrusion of each seat unit can move in one direction in the first limiting hole and the second limiting hole of the adjacent seat unit, respectively.

[0020] As another aspect of the present invention, an embodiment of the present invention provides a pre-positionable artificial bioprosthetic valve, which may include: three leaflets and the aforementioned artificial bioprosthetic valve support; the three leaflets are sutured to three leaflet struts in the valve support; the size specifications of the three leaflets are matched with the size specifications of the valve seat in the second state.

[0021] As another aspect of the present invention, the present invention provides a pre-positionable artificial bioprosthetic valve implantation system, which may include: a valve holder, an artificial bioprosthetic valve delivery mechanism and the above-mentioned pre-positionable artificial bioprosthetic valve;

[0022] The valve holder is sutured to the pre-positionable artificial bioprosthetic valve;

[0023] The artificial bioprosthetic valve delivery mechanism is connected to the valve holder.

[0024] In one embodiment, the valve holder may include: three integrally formed connecting claws and a first connecting seat;

[0025] The connecting claw has a suture hole at one end away from the first connecting seat; the valve holder is connected to the suture of the covering material outside the leaflet support of the valve frame in the pre-positionable artificial bio-valve through the suture hole.

[0026] The first connector is ring-shaped and has an installation port for connecting to the artificial bio-valve delivery mechanism.

[0027] In one embodiment, the periphery of the first connector is provided with a marking platform for marking valve size.

[0028] As another aspect of the present invention, an embodiment of the present invention provides an application of the above-described artificial bio-valve stent in a pre-positionable artificial bio-valve implantation system.

[0029] As another aspect of the present invention, embodiments of the present invention provide an application of the above-described prepositionable artificial biovalve in a prepositionable artificial biovalve implantation system.

[0030] The beneficial effects of the above-mentioned technical solutions provided in the embodiments of the present invention include at least the following:

[0031] This invention provides an artificial bioprosthetic valve stent, a pre-positionable artificial bioprosthetic valve, an implantation system, and its application. The artificial bioprosthetic valve stent features two functional zones: a valve seat and an anchoring seat. In a first state, the area where the anchoring blocks are positioned on the anchoring seat is radially concave, and the outer diameter of the circle containing the outer edges of the three anchoring blocks is smaller than the outer diameter of the valve seat, significantly reducing the overall radial profile of the stent and facilitating its pre-positioning in the delivery system and delivery to the target location. In a second state, the anchoring seat expands into a ring shape, and the outer diameter of the circle containing the outer edges of the anchoring blocks is larger than the outer diameter of the valve seat, enabling three-point mechanical anchoring of the three anchoring blocks corresponding to the leaflet strut positions. This design not only significantly shortens the operation time and reduces extracorporeal circulation trauma but also effectively avoids excessive compression of the valve annulus tissue caused by the expansion of traditional circumferential full-ring stents, reducing postoperative complications such as arrhythmias. Furthermore, the differentiated expansion of the valve seat and anchoring seat achieves stable fixation and effective sealing, ensuring anchoring reliability while reducing paravalvular leakage. It is particularly suitable for minimally invasive valve replacement surgery in patients with small aortic valve annulus, combining the advantages of simple operation, reliable positioning, and optimized hemodynamics.

[0032] Other features and advantages of the invention will be set forth in the following description, and will be apparent in part from the description, or may be learned by practicing the invention. The objects and other advantages of the invention may be realized and obtained by means of the structures particularly pointed out in the written description and the accompanying drawings.

[0033] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. Attached Figure Description

[0034] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used in conjunction with embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings:

[0035] Figure 1 A structural diagram of a hybrid prosthetic aortic valve provided in the prior art;

[0036] Figure 2 This is a structural diagram of a support frame provided in the prior art;

[0037] Figure 3 This is a structural diagram of the artificial bioprosthetic valve stent (first state before dilation) provided in an embodiment of the present invention;

[0038] Figure 4 This is a structural diagram of the artificial bio-valve stent (second state after expansion) provided in an embodiment of the present invention;

[0039] Figure 5 This is a structural diagram of a pre-positionable artificial bioprosthetic valve (first state before expansion) provided in an embodiment of the present invention;

[0040] Figure 6 This is a structural diagram of a pre-positionable artificial bioprosthetic valve (second state after expansion) provided in an embodiment of the present invention;

[0041] Figure 7 This is a physical image of a pre-configurable artificial bio-valve (first state before expansion) provided in an embodiment of the present invention;

[0042] Figure 8 This is a physical image of a pre-configurable artificial bio-valve (in normal use after expansion) provided in an embodiment of the present invention;

[0043] Figure 9 This is one of the structural diagrams of the anchoring seat and anchoring block provided in the embodiments of the present invention;

[0044] Figure 10 This is the second structural diagram of the anchoring seat and anchoring block provided in the embodiments of the present invention; Figure 11 for Figure 9 A magnified view of a section at point A in the middle;

[0045] Figure 12 This is the third structural diagram of the anchoring seat and anchoring block provided in the embodiments of the present invention;

[0046] Figure 13 The image shows the actual application effect of the pre-configurable artificial bio-valve provided in the embodiments of the present invention.

[0047] Figure 14This is a structural diagram showing the connection between a pre-positionable artificial bioprosthetic valve (first state before dilation) and a valve holder provided in an embodiment of the present invention;

[0048] Figure 15 This is a structural diagram showing the connection between a pre-positionable artificial bioprosthetic valve (second state after expansion) and a valve holder provided in an embodiment of the present invention;

[0049] Figure 16 This is a front view of the valve holder provided in an embodiment of the present invention;

[0050] Figure 17 This is a top view of the valve holder provided in an embodiment of the present invention;

[0051] Figure 18 A schematic diagram of the artificial bio-valve delivery mechanism (before dilation) provided in an embodiment of the present invention;

[0052] Figure 19 A schematic diagram of the artificial bio-valve delivery mechanism (after expansion) provided in an embodiment of the present invention;

[0053] Figure 20 for Figure 18 Cross-sectional view;

[0054] Figure 21 for Figure 20 A magnified view of a section at point B in the middle;

[0055] Figure 22 for Figure 20 A magnified view of a section at point C;

[0056] Figure 23 for Figure 20 A magnified view of a section at point D;

[0057] Figure 24 for Figure 20 A magnified view of a section at point E in the middle;

[0058] Figure 25 This is a sectional view of multiple components of the artificial bio-valve delivery mechanism provided in an embodiment of the present invention;

[0059] Figure 26 This is an overall structural diagram of the second connector provided in an embodiment of the present invention;

[0060] Figure 27 This is an overall structural diagram of the second connector provided in an embodiment of the present invention;

[0061] Figure 28 This is an overall structural diagram of the pre-positionable artificial bioprosthetic valve implantation system (before dilation) provided in an embodiment of the present invention;

[0062] Figure 29This is an overall structural diagram of the pre-positionable artificial bioprosthetic valve implantation system (after expansion) provided in an embodiment of the present invention;

[0063] Among them, 1-artificial bioprosthetic valve stent; 2-valve leaflet; 3-valve holder; 4-artificial bioprosthetic valve delivery mechanism;

[0064] 11-Valve frame; 12-Valve seat; 13-Anchor seat; 14-Anchor block; 15-Covering material;

[0065] 111-Leaf support; 121-Seat unit; 122-First rivet; 123-Limiting protrusion; 124-First elongated groove; 125-Second elongated groove; 126-First limiting hole; 127-Second limiting hole; 128-Second rivet;

[0066] 31-Connecting claw; 32-First connecting seat; 33-Sewing hole; 34-Installation port; 35-Marking platform;

[0067] 401-Connector; 402-First connector; 403-Second connector; 404-Spring; 405-Handle; 406-Outer tube; 407-Inner tube; 408-Third connector; 409-Second connector; 410-Balloon; 411-First axial clearance; 412-Sealing ring; 413-Second channel; 414-Third channel;

[0068] 4011-Limiting boss; 4021-First connecting hole; 4031-Limiting post; 4032-Second connecting hole; 4033-Spine; 4034-First channel; 4051-Third connecting hole; 4052-Fourth connecting hole; 4091-Cap body; 4092-Cylinder body; 4093-Circumferential protrusion; 4094-Gutter; 4095-Snap-fit ​​part;

[0069] 100 - Hybrid prosthetic aortic valve; 101 - Skirt; 102 - Valve tip marker; 103 - Arch marker; 104 - Valve union column; 105 - Stent frame; 106 - Top; 107 - Mesh strut. Detailed Implementation

[0070] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0071] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," "outer," "far," "near," "front," and "rear," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0072] 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 fixed 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 can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0073] The applicant previously developed and proposed a pre-positionable artificial bio-aortic valve (application publication number CN116196151A), which increases the valve size through balloon dilation, thereby avoiding aortic root enlargement surgery and creating conditions for subsequent valve-in-valve treatment. However, this valve still needs to be fixed to the autologous valve annulus with sutures one stitch at a time. This suture fixation method takes up a lot of surgical time and has the disadvantages of long operation time, large trauma, and insufficient suturing, which can easily lead to paravalvular leakage.

[0074] In addition, there is a hybrid prosthetic aortic valve in the existing technology, referring to... Figure 1 and Figure 2 As shown, the lower part of the hybrid prosthetic aortic valve 100 is sutured to a skirt 101 via a covering. The aortic valve 100 has three distinct valve tip markers 102 around its periphery. An elongated arcuate marker 103 extends between two of the valve tip markers 102, centered on the valve union column 104. The arcuate marker 103 can be formed by a printed indicator or by sewing one or more sutures of appropriate length along a suitable area. Figure 1 In the hybrid prosthetic aortic valve 100 shown, the skirt 101 is internally covered with a stent frame 105 (see Figure 2The stent frame 105 no longer has a mesh strut 107 in its top region 106. This design improves the structure of existing aortic valves and can reduce postoperative palpitations, fatigue, decreased ventricular rate, bradycardia-dependent heart failure, and arrhythmias. Although this hybrid prosthetic aortic valve attempts to alleviate postoperative arrhythmias by improving the skirt structure and stent frame 105 design, these symptoms are not fundamentally improved because it relies on circumferential stent expansion and anchoring.

[0075] In summary, current technologies still lack an artificial bioprosthetic valve solution that can simultaneously achieve rapid anchoring, effectively avoid paravalvular leakage, significantly reduce the risk of postoperative arrhythmias, and is suitable for patients with small aortic annulus. Therefore, there is an urgent need to propose a novel valve design to overcome the aforementioned multiple clinical challenges.

[0076] During the research and development process, the inventors discovered that existing valve products could not simultaneously address surgical efficiency, anchoring stability, postoperative complication control, and the specific needs of patients with small aortic valve annulus. To address common issues such as long surgical time, high incidence of paravalvular leaks, and postoperative symptoms like palpitations, fatigue, decreased ventricular rate, bradycardia-dependent heart failure, and arrhythmias, the inventors attempted to make separate technical improvements, but individual adjustments failed to achieve the desired results.

[0077] To overcome this predicament, the inventors shifted their research approach, systematically integrating and studying the aforementioned problems. They abandoned the traditional anchoring method that relied on circumferential expansion to compress the valve annulus. Instead, they designed an anchoring seat at the bottom of the valve, with three independently adjustable anchoring blocks on it. By optimizing the geometry and outer diameter of the anchoring seat, the three rubber anchoring blocks can precisely conform to and anchor to the aortic valve annulus, thereby achieving rapid and stable fixation of the valve on the ventricular surface and significantly shortening the operation time.

[0078] Meanwhile, to effectively prevent paravalvular leakage, the inventors further optimized the valve seat that houses the valve leaflets. By designing the valve seat as a unidirectional, limit-expansion structure, it can form a morphologically stable support ring after balloon dilation, thereby tightly adhering to the aortic valve annulus and surrounding tissues, structurally sealing potential paravalvular leakage gaps.

[0079] The ingenuity of this invention lies in its synergistic design of bottom-mounted anchoring and upper expansion sealing, which not only solves the problems of cumbersome and time-consuming traditional valve implantation procedures but also effectively reduces the incidence of paravalvular leakage. More importantly, by avoiding the continuous high-pressure expansion of the circumferential region in the valve annulus region, it significantly reduces mechanical stimulation to surrounding tissues, thereby effectively reducing the risk of a series of related complications such as postoperative palpitations, fatigue, bradycardia, and arrhythmias. In particular, it provides a novel solution for patients with small aortic valve annulus that combines excellent hemodynamic performance with good long-term prognosis.

[0080] This invention provides an artificial bioprosthetic valve stent, as shown in the following embodiment. Figures 3-13 As shown, the artificial bioprosthetic valve stent 1 may include: a valve frame 11, a valve seat 12, an anchor 13, and three anchor blocks 14 sleeved on the anchor seat 13; the valve frame 11 has three leaflet supports 111; the valve seat 12 is an annular metal seat, the valve frame 11 is embedded above the valve seat 12 and is sutured to the valve seat 12 through a covering 15; the anchor seat 13 is a balloon-expandable annular metal seat 410, the anchor seat 13 is located on the side opposite to the valve frame 11 and is connected to the valve seat 12 through the covering 15. 2. Suture connection; the three anchor blocks 14 correspond to the positions of the three leaflet supports 111 in the valve frame 11; the artificial biological valve stent 1 has a first state and a second state; in the first state, the area where the anchor blocks 14 are set on the anchor seat 13 is radially concave inward along the anchor seat 13, and the outer diameter of the circle where the outer edges of the three anchor blocks 14 are located is smaller than the outer diameter of the valve seat 12; in the second state, the anchor seat 13 is annular, and the outer diameter of the circle where the outer edges of the three anchor blocks 14 are located is larger than the outer diameter of the valve seat 12.

[0081] It should be noted that the material of the covering 15 in this embodiment can be polyester, and the material of the suture used for sewing can also be polyester. The material of the anchor block 14 can be elastic polymer materials such as rubber and silicone, and its shape can be cube, cuboid, column, or rugby ball. Preferably, the edges and corners of the anchor block 14 are rounded. It should also be noted that the petal seat 12 in this embodiment can be an existing fixed-size annular metal seat.

[0082] The artificial bioprosthetic valve stent 1 provided in this embodiment of the invention has two functional zones: a valve seat 12 and an anchoring seat 13. In the first state, the area on the anchoring seat 13 where the anchoring blocks 14 are set is radially concave and the outer diameter of the circle containing the outer edges of the three anchoring blocks 14 is smaller than the outer diameter of the valve seat 12, which significantly reduces the overall radial profile of the stent, making it easier to pre-place it in the delivery system and deliver it to the target location. In the second state, the anchoring seat 13 expands into a ring shape and the outer diameter of the circle containing the outer edges of the anchoring blocks 14 is larger than the outer diameter of the valve seat 12, so that the three anchoring blocks corresponding to the positions of the leaflet support 111 can accurately achieve three-point mechanical anchoring. This structural design not only significantly shortens the operation time and reduces cardiopulmonary bypass trauma, but also effectively avoids excessive compression of the valve annulus tissue by the traditional circumferential full-ring stent, reducing the occurrence of postoperative complications such as arrhythmia. Furthermore, the differentiated expansion of the valve seat 12 and the anchor seat 13 achieves stable fixation and effective sealing, thereby reducing paravalvular leakage while ensuring anchoring reliability. It is especially suitable for minimally invasive valve replacement surgery for patients with small aortic valve annulus, and has the comprehensive advantages of simple operation, reliable positioning and optimized hemodynamics.

[0083] In one embodiment, the above-mentioned valve seat 12 is further optimized, referring to... Figures 3-12 As shown, the above-mentioned valve seat 12 is a unidirectional, limit-expanding annular metal seat; in the first state, the outer diameter of the valve seat 12 is smaller than the outer diameter of the valve seat 12 in the second state; in the first state, the ratio of the outer diameter of the valve seat 12 to the outer diameter of the anchor seat 13 is 1.04:1 to 1.1:1; in the second state, the ratio of the outer diameter of the valve seat 12 to the outer diameter of the anchor seat 13 is 1:1.

[0084] In this embodiment, the artificial bioprosthetic valve stent 1 has an outer diameter ratio (1.04:1~1.1:1) in the first state, making the valve seat 12 slightly larger than the anchor seat 13 during the delivery stage. This is beneficial to the structural compactness of the valve in the pre-positioned state and the ease of loading the artificial bioprosthetic valve delivery mechanism. After the balloon expands to the second state, the outer diameter ratio of the valve seat 12 to the anchor seat 13 reaches 1:1, ensuring that the valve seat 12 and the anchor seat 13 expand synchronously and uniformly. This allows the valve to form a flat and continuous circumferential support structure after implantation, thereby effectively eliminating the radial step difference between the valve seat 12 and the anchor seat 13, enhancing the fit and sealing between the valve and the autologous valve annulus, significantly reducing the risk of paravalvular leakage, and providing a stable and consistent geometric basis for the normal opening and closing of the valve leaflets, thus improving the long-term hemodynamic performance and durability of the artificial bioprosthetic valve.

[0085] In one embodiment, refer to Figure 11 and Figure 12 As shown, the length a of the anchor block 14 along the circumferential direction of the anchor seat 13 is 5-7 mm; the width b0 of the anchor block 14 along the radial direction of the anchor seat 13 is 4-6 mm; and the height c of the anchor block 14 perpendicular to the length and width directions is 4-7 mm.

[0086] This embodiment achieves a good balance between anchoring performance and delivery passability by synergistically optimizing the three-dimensional dimensions of the anchoring block 14. On the one hand, it enables the anchoring block 14 to form a stable mechanical interlock with the autologous valve annulus after balloon dilation, significantly improving the anti-displacement capability and long-term anchoring reliability of the implanted artificial bioprosthetic valve. On the other hand, this size range ensures that the anchoring block 14 has sufficient structural strength to maintain the positional stability of the valve under normal use, while avoiding the impact on the loading diameter of the delivery system or the increase in radial resistance during valve release due to the excessive size of the anchoring block 14. In addition, the reasonable distribution of the anchoring blocks within the above-mentioned size range around the anchoring seat 13 helps to establish a uniform circumferential support force distribution after dilation, avoiding deformation of the valve frame 11 or abnormal leaflet alignment caused by local stress concentration, thereby ensuring the hemodynamic performance and long-term durability of the valve under normal use. By optimizing the size of the anchor block 14, postoperative complications such as palpitations were reduced, and a larger effective opening area was provided for patients with small aortic valve annulus, improving hemodynamic performance. Overall, a combination of rapid and stable implantation and good clinical prognosis was achieved.

[0087] In one embodiment, along the radial direction of the anchor seat 13, the width of the anchor block 14 located outside the anchor seat 13 accounts for 15% to 20% of the total width of the anchor block 14. (Refer to...) Figure 11 As shown, the width of the anchor block 14 located outside the anchor seat 13 is b2, and the total width of the anchor block 14 is b0, that is, b2 accounts for 15% to 20% of b0.

[0088] In this embodiment, the width of the anchor block 14 located radially outside the anchor seat accounts for 15% to 20% of its total width. This proportion ensures that the anchor block 14 has sufficient radial extension after balloon dilation to form a stable mechanical interlock with the autologous valve annulus, thereby providing reliable three-point anchoring force and preventing valve displacement or rotation during cardiac pulsation. Furthermore, it avoids excessive outward extension of the anchor block 14, which could lead to excessive local stress or unnecessary damage to surrounding tissues after implantation. Simultaneously, within this proportion, the anchor block 14 can achieve a coordinated radial dimensional fit with the valve seat, which helps maintain the overall structural balance and fit stability of the stent during dilation, further reducing the risk of paravalvular leakage and improving the long-term durability of the valve after implantation.

[0089] In one embodiment, refer to Figures 3-9 As shown, in the second state, the ratio of the outer diameter of the petal seat 12 to the outer diameter of the circle containing the outer edges of the three anchor blocks 14 is 1:1.1 to 1:1.3.

[0090] In this embodiment, by making the outer diameter of the expanded valve seat 12 slightly smaller than the diameter of the circumscribed circle formed by the three anchor blocks 14, on the one hand, by making the radial projection of the anchor blocks 14 extend beyond the outer edge of the valve seat 12, a clear anchoring radius advantage is formed, ensuring that the three anchor blocks 14 can form a stable mechanical interlock with the autologous valve annulus structure after expansion, effectively resisting the axial displacement and circumferential rotation of the valve during cardiac cycle, and improving the anti-dislodgement and anti-displacement ability of the valve after long-term implantation; on the other hand, this radial size ratio limits the excessive expansion of the anchor blocks, avoiding unnecessary compression or friction on the surrounding tissues due to the anchoring structure occupying too much space, while ensuring the fit and sealing between the valve seat and the inner wall of the autologous valve annulus, thereby achieving an optimized balance between anchoring reliability and implantation safety.

[0091] In one embodiment, refer to Figures 3-9 As shown, the three anchoring blocks 14 can be individually adjusted in their preset areas on the anchoring seat 13. In this embodiment, the three anchoring blocks 14 can be individually adjusted in their preset areas on the anchoring seat 13. During the expansion of the artificial bioprosthetic valve stent from the first state to the second state, this structural feature allows the operator to independently fine-tune the final circumferential fixation position of each anchoring block 14 relative to the anchoring seat 13 according to the actual anatomical structure during surgery. This allows each anchoring block to fit more evenly and stably to the corresponding anchoring site of the autologous valve annulus, thereby improving the fit and stability of the anchoring. This design avoids uneven distribution of anchoring force caused by misalignment between the anchoring blocks 14 and the local structure of the valve annulus, effectively reducing the risk of postoperative valve displacement or paravalvular leakage. On the other hand, through the position adjustment capability, adaptive matching of the anchoring points can be achieved before the stent is fully expanded, thereby improving the reliability of the overall valve anchoring and the long-term stability after implantation. Compared to fixed-position anchoring, this design significantly enhances the product's adaptability to different individual anatomical variations, not only optimizing the anchoring effect and reducing the risk of displacement, but also improving the safety of implantation and long-term functional reliability.

[0092] In one embodiment, refer to Figure 3 and Figure 4As shown, the valve seat 12 of the aforementioned artificial bioprosthetic valve stent 1 is composed of several overlapping and interconnected seat units 121. Each seat unit 121 has a first rivet 122, a limiting protrusion 123, and a first elongated groove 124 at its front end, arranged from the outside inwards. Each seat unit 121 has a second elongated groove 125 that mates with the first rivet 122 at the front end of the adjacent seat unit 121, a second limiting hole 127 that mates with the limiting protrusion 123, and a first limiting hole 126 at its rear end. The first elongated groove 124 of each seat unit 121 engages with the second rivet 128 of the adjacent seat unit 121 and can move in one direction. The second elongated groove 125 of each seat unit 121 engages with the first rivet 122 of the adjacent seat unit 121 and can move in one direction. The limiting protrusion 123 of each seat unit 121 can move in one direction in the first limiting hole 126 and the second limiting hole 127 of the adjacent seat unit 121 respectively.

[0093] In this embodiment, the valve seat 12, through several overlapping and interlocking seat units 121 and mutually cooperating structures such as the first rivet 122, limiting protrusion 123, elongated groove, and limiting hole, achieves unidirectional and limited expansion of the valve seat during balloon 410 expansion. This expansion is controllable, segmented, and irreversible radial expansion. This structure forms a self-locking mechanism after expansion to a preset size, effectively preventing the valve seat 12 from retracting, thereby ensuring a stable and precise support diameter for the artificial bio-valve in vivo, avoiding valve dysfunction or paravalvular leakage due to unstable valve seat 12 dimensions. Simultaneously, this unidirectional limited expansion structure allows the valve seat 12 to maintain a small preset outer diameter in the first state, facilitating loading and delivery. After balloon expansion, it reliably maintains the outer diameter in the second state (normal use state), achieving a balance between delivery and anchoring performance, significantly improving the positioning accuracy and long-term structural stability of valve implantation.

[0094] Specifically, after expansion, the valve seat 12 can be stably locked at a preset size, avoiding paravalvular leakage or structural failure caused by elastic recoil or over-expansion. This ensures that the valve fits tightly with the patient's valve annulus after implantation, improving anchoring stability. It also provides a reliable structural basis for achieving a "larger" implantation during surgery, helping to improve postoperative hemodynamics and reduce the risk of complications. It should be noted that a detailed description of the specific structure of the valve seat 12 in this embodiment can be found in the relevant description in the application publication number CN116196151A, "A Pre-positionable Artificial Biological Aortic Valve," and will not be repeated here.

[0095] The artificial bioprosthetic valve stent 1 provided in this invention, through its innovative structural design, solves several key clinical problems existing in the prior art and achieves significant and synergistic beneficial effects, as detailed below:

[0096] The core of this invention lies in abandoning the traditional artificial valve anchoring method that relies on circumferential expansion and compression of the valve annulus. Instead, it employs a composite mechanism combining a biomimetic, anatomically adapted three-point anchoring with an upper active seal. This design cleverly unifies three traditionally difficult-to-achieve goals: "rapid and stable anchoring," "effective prevention of paravalvular leakage," and "reduction of postoperative complications," achieving synergistic effects. Specific beneficial effects are analyzed below:

[0097] (1) Achieve rapid, stable and minimally invasive anchoring, significantly shortening the operation time.

[0098] The stent is directly fitted and fixed to the autologous aortic valve annulus via three anchor blocks 14 on its anchor seat 13, avoiding the extensive and time-consuming annulus suturing required in traditional surgical valve procedures. The anchor blocks 14 are designed to match the human anatomy, providing a clear and stable anchoring point. Intraoperative rotational adjustments facilitate precise alignment, improving the certainty and success rate of implantation. The rapid anchoring process significantly reduces the duration of cardiac arrest and cardiopulmonary bypass, thereby lowering the risks of systemic inflammation, coagulation disorders, and organ damage associated with prolonged cardiopulmonary bypass, which is particularly beneficial for elderly and high-risk patients.

[0099] (2) Effectively reduce the incidence of paravalvular leakage and ensure good hemodynamic effects.

[0100] The valve seat 12 features a unidirectional, limit-expansion design. After balloon 410 expansion, it stably expands to a preset size and locks, forming a support ring on the aortic side that closely conforms to the autologous valve annulus and surrounding tissue. This active radial support effectively seals any potential gaps between the valve stent 11 and the autologous tissue. Three-point anchoring provides stable axial fixation, preventing overall valve displacement; while the expansion seal of the upper valve seat 12 provides reliable radial closure. These two elements constitute a dual guarantee, structurally maximizing the prevention of paravalvular leakage. Simultaneously, because no space is required for a pre-existing suture ring, the stent can provide a larger effective opening area for the leaflet 2, which is beneficial for achieving better hemodynamic performance (such as a lower transvalvular pressure gradient) and improving cardiac function.

[0101] (3) Significantly reduces postoperative arrhythmias and related complications

[0102] This invention optimizes the dimensions of the anchor block 14 to ensure it possesses sufficient mechanical strength for stable anchoring, while avoiding undue pressure on surrounding tissues due to excessive size or protrusion. The invention employs a discrete three-point anchoring method to replace the comprehensive compression of the valve annulus by the traditional circumferential annular stent, avoiding direct, large-area contact with critical cardiac regions. Combined with the optimized dimensions of the anchor block 14, this effectively reduces the incidence of postoperative arrhythmias and related complications.

[0103] (4) It is particularly suitable for patients with small aortic valve annulus and leaves room for treatment.

[0104] In its first state (original state), the stent has a small outer diameter, facilitating passage through narrow valve annulus. After expansion to the second state via balloon 410, the ratio of the outer diameter of valve seat 12 to that of anchor seat 13 becomes 1:1, achieving effective radial expansion. This makes it possible to implant a relatively larger valve for patients with small aortic valve annulus, directly alleviating the problem of size mismatch between the patient and the prosthetic valve. The outer contour formed by the expansion of anchor block 14 is larger than the outer diameter of valve seat 12, preventing the anchoring structure from encroaching on the central area of ​​the valve orifice, thus providing sufficient opening space for leaflet 2. The larger effective opening area reduces postoperative transvalvular pressure gradient and improves cardiac output. At the same time, the initially implanted valve has a relatively large inner diameter after expansion, reserving valuable space for future transcatheter "valve-in-valve" intervention after the bioprosthetic valve fails, avoiding the dilemma of being unable to perform secondary minimally invasive intervention due to the initial implanted valve being too small.

[0105] (5) The structural design is reliable and the operation is safe and controllable.

[0106] The unique interlocking unit design of the valve seat 12 ensures dimensional stability after expansion, preventing paravalvular leakage or valvular insufficiency caused by elastic recoil. The dimensions of the anchor block 14 (5-7 mm long, 4-6 mm wide, 4-7 mm high) and its width ratio inside and outside the valve seat (15-20% on the outer side) are optimized to ensure sufficient anchoring force while avoiding excessive protrusion that could damage surrounding tissues. In the second state, the ratio of the outer diameter of the valve seat 12 to the outer diameter of the circle containing the anchor block 14 (1:1.1~1:1.3) ensures coordinated operation of the upper sealing ring and the bottom anchoring system, preventing interference and further enhancing the operational safety and implantation reliability of the overall structure.

[0107] In summary, the artificial bioprosthetic valve stent 1 provided in this embodiment of the invention, through its integrated design of "three-point anatomical anchoring at the bottom + unidirectional expansion and sealing at the top," combined with optimized anchoring block parameters, unidirectional limiting expansion of the valve seat, and multi-level size ratio coordination, successfully solves multiple clinical challenges, including rapid implantation, stable anchoring, long-lasting sealing, reduced complications, and adaptation to small valve annulus anatomy. This stent not only simplifies the surgical procedure and reduces surgical risks, but more importantly, it reduces interference with the physiological structure of the heart, providing patients with a safer, more effective, and better long-term prognosis aortic valve replacement solution.

[0108] Based on the same inventive concept, this invention also provides a pre-positionable artificial bioprosthetic valve, as described above. Figures 5-7 as well as Figure 13As shown, it may include: three leaflets 2 and the aforementioned artificial biological valve stent 1; the three leaflets 2 are sutured to the three leaflet supports 111 in the valve stent 11; the size specifications of the three leaflets 2 match the size specifications of the valve seat 12 in the second state.

[0109] This embodiment achieves precise geometric adaptation between the leaflet 2 and the valve seat 12 in the second state by suturing three leaflet 2 pieces of the same size as the valve seat 12 in the second state to the three leaflet supports 111 of the valve frame 11, and by combining the expandable valve seat 12 and the anchor seat 13 structure. This ensures that the opening and closing shape of the leaflet 2 after expansion is controllable and the alignment is tight, thereby significantly reducing the risk of postoperative paravalvular leakage. Meanwhile, because the valve can be stably anchored by the anchor block without the need for traditional suture fixation, the intraoperative cardiopulmonary bypass time is significantly shortened, and the burden of cardiac function recovery caused by operative trauma is reduced. This reduces the occurrence of palpitations, fatigue, decreased ventricular rate, bradycardia-dependent heart failure, and arrhythmias, making it particularly suitable for clinical scenarios requiring rapid deployment and long-term hemodynamic stability. In addition, during delivery and expansion, the specific connection between the valve holder 3 and the leaflet strut 111 limits valve angle deformation, protects the leaflet 2 from damage by the balloon 410, and ensures the integrity of the valve opening and closing function. Overall, this structure achieves a safer, faster, and more hemodynamically superior "sutureless" valve replacement under conditions of small aortic valve annulus.

[0110] It should be further clarified that the pre-positionable artificial bio-valve provided in this embodiment is a "sutureless" valve, meaning that the valve does not need to be fixed to the aortic valve annulus by sutures. Those skilled in the art will understand that in aortic valve replacement surgery, three sutures are typically placed at the center of the three valve sinuses: the left coronary sinus, the right coronary sinus, and the non-coronary sinus. These three sutures act as traction lines; by pulling these three sutures, the valve annulus can be fully exposed and compressed, creating space and a field of vision for implanting the artificial bio-valve. The aforementioned three sutures do not conflict with the pre-positionable artificial bio-valve provided in this embodiment being a "sutureless" valve, and those skilled in the art should not misunderstand this.

[0111] According to data from the SURE-AVR global registry study (1652 patients), the mean aortic cross-clamp time on the Perceval platform was 51.0 minutes (SD 20.5), and the mean cardiopulmonary bypass time was 77.4 minutes (SD 30.8). Compared to traditional sutured valves, the valve described above in this embodiment is a sutureless valve, reducing the operation time by approximately 12-22 minutes, which is clinically significant for reducing myocardial ischemia time.

[0112] The pre-positionable artificial bioprosthetic valve provided in this embodiment of the invention is based on the aforementioned artificial bioprosthetic valve stent 1, further integrating three leaflets 2 and precisely matching their dimensions with the valve seat 12 in the second state, thereby forming a pre-assembled, ready-to-use complete functional unit. It not only inherits all the core advantages of the artificial bioprosthetic valve stent 1 in the above embodiments, but also achieves superior clinical performance and operational characteristics through overall design and manufacturing processes.

[0113] This pre-positionable bioprosthetic valve offers integrated advantages and enhances performance from stent to complete valve. It organically integrates an innovative stent structure with three bioprosthetic leaflets 2 and a covering 15, forming a unified treatment component. This integrated design avoids the cumbersome intraoperative assembly of leaflet 2 and stent, ensuring consistency and reliability in the suture position, angle, and tension of leaflet 2, and directly translating the mechanical expandability of the stent into immediate opening and closing function after valve implantation. Specific beneficial effects are as follows:

[0114] (1) Achieve "expansion as soon as it works", optimize and ensure postoperative hemodynamic performance.

[0115] The leaflet 2 is precisely matched to the valve seat 12 in the stent. That is, the size of the three leaflets 2 is designed to strictly match the size of the valve seat 12 in the second state (i.e., the normal use state after balloon dilation). This matching relationship ensures that after the valve expands from the first state to the second state with the valve seat 12, the leaflet 2 can achieve normal occlusion and opening / closing functions within the optimized frame geometry without any intraoperative adjustments.

[0116] This design optimizes the effective opening area. Because the valve seat 12 in the second state expands unidirectionally to form a larger inner diameter, and the three anchoring blocks 14 extend and anchor after expansion without encroaching on the central blood flow channel, the overall structure can provide a larger effective opening area for the leaflet 2. This directly results in a significant reduction in transvalvular pressure gradient and an effective increase in cardiac output postoperatively, which is particularly beneficial for improving hemodynamic load in patients with small aortic annulus and heart failure.

[0117] The design pre-optimizes the fluid morphology. The suture position, height, and overlapping relationship of the leaflet 2 on the valve frame have been optimized during the manufacturing stage according to the shape of the valve seat 12 in the second state. This helps to form a regular central blood flow when the valve is open and reduce stress concentration of the leaflet 2 when it is closed, thereby reducing turbulence and stagnant areas, delaying leaflet 2 tissue fatigue and extending valve life.

[0118] (2) Simplify intraoperative procedures and shorten critical surgical time.

[0119] This valve is pre-installed and ready to use. During the manufacturing stage, all sutures between the leaflet 2 and the valve frame 11, the covering 15 and the valve seat 12, and the anchor 13 are completed, and the valve is pre-installed on the valve holder 3 in its first state (original compressed state) or ready for use. The surgeon does not need to assemble the leaflet 2, perform trial valve tests, or adjust the size under cardiopulmonary bypass. It can be used with the valve holder and delivery mechanism immediately after unpacking, which significantly simplifies the surgical preparation process.

[0120] This valve facilitates rapid positioning and rotation during surgery. The complete valve structure provides the surgeon with clear visual reference boundaries (such as the position of the valve support 111 of the valve frame 11, the edge of the covering 15, etc.). Combined with the suture connection point of the covering of the leaflet support 111 corresponding to the connecting claw of the valve holder 3, it provides clear structural feedback when rotating and adjusting the valve position in the body, making it easy to accurately deliver the three anchor blocks 14 to the target position corresponding to the root of the three leaflet junctions of the autologous valve annulus.

[0121] The valve is compatible with standard delivery mechanisms. The pre-positionable valve is designed to work in conjunction with the matching artificial bio-valve delivery mechanism 4 and valve holder 3 to form a standardized operating procedure from loading, in vivo delivery, rotational positioning, balloon dilation to release and withdrawal, reducing the technical learning curve and improving the repeatability and safety of the surgery.

[0122] (3) Synergistic effect of enhancing implant stability and sealing

[0123] The dual functions of the covering 15 are as follows: Promoting tissue endogenous growth: The fabric material (such as polyester) covering the stent provides a good matrix for rapid creeping growth of host tissue post-surgery, which is beneficial for long-term valve stability and biological fixation, further reducing the risk of long-term valve displacement or rotation. Assisting sealing: The covering 15 increases the flexibility and tissue adaptability of the aortic wall contact surface between the stent and the autologous valve annulus, especially in the area where the valve seat 12 adheres to the inner wall of the valve annulus in the second state, better compensating for anatomical irregularities, assisting in improving the sealing effect and reducing the probability of paravalvular leakage. Structural integrity ensures anchoring effect: As a complete component with pre-placed sutures, during balloon dilation, the internal suture connections and the constraint of the covering 15 together maintain the relative positional relationship between the valve seat 12, the anchor seat 13, and the three anchor blocks 14, ensuring that the three anchor blocks 14 move outward and embed into the target anatomical position in a coordinated and synchronous manner, achieving the designed three-point mechanical anchoring force distribution.

[0124] (4) Provides the ability to "upsize" implantation for small aortic valve annulus and reserves space for long-term intervention.

[0125] The valve features a "pre-compression-post-expansion" mechanism. The valve is stored and delivered in a smaller first state, in which the ratio of the outer diameter of the valve seat 12 to the outer diameter of the anchor 13 is 1.04:1 to 1.1:1, and the overall profile is small. After intraoperative expansion to the second state with the assistance of balloon 410, the ratio of the outer diameter of the valve seat 12 to the outer diameter of the anchor 13 becomes 1:1, and the outer diameter of the circle containing the outer edges of the three anchor blocks 14 is larger than the outer diameter of the valve seat 12. This allows surgeons to select and implant a valve one size larger than the measured size of the patient's own valve annulus for patients with small aortic valve annulus without the need for additional root enlargement surgery.

[0126] This direct artificial valve-patient mismatch (PPM): Through the above-mentioned "size-up" implantation, this valve can provide a larger effective opening area within the limited autologous anatomical space. It is an effective means to directly combat the PPM problem from a hemodynamic perspective, which helps to improve postoperative ventricular remodeling and improve long-term survival.

[0127] Reserved space for "valve-in-valve" treatment: Because the valve implanted for the first time has a larger inner diameter in the second state after expansion, it reserves sufficient and valuable internal space for future transcatheter valve-in-valve re-intervention treatment that may be required due to valve failure. This avoids the clinical dilemma of limited secondary minimally invasive intervention pathways due to the small size of the valve implanted for the first time.

[0128] (5) Potential to improve long-term durability and postoperative quality of life for patients

[0129] Optimizing the load environment: By providing a larger opening area and a lower transvalvular pressure gradient, the valve experiences relatively lower mechanical stress during each cardiac cycle, while the left ventricular afterload is more effectively reduced. This may help delay the structural degeneration of the valve leaflet tissue and have a positive impact on postoperative myocardial remodeling.

[0130] Reduced risk of re-intervention: The synergistic sealing design of the expanded anchor block 14 and valve seat 12 significantly reduces the incidence of paravalvular leakage, while the stable three-point anchoring structure avoids the risk of overall valve displacement or rotation. These features together reduce the probability of needing re-operation due to early or mid-term functional abnormalities.

[0131] Improved postoperative exercise tolerance: Excellent hemodynamic release (low pressure gradient, large opening area) combined with lower surgical trauma and complication risk, allows patients to have higher cardiac function reserve during the postoperative recovery period, and is expected to have better exercise tolerance and quality of life than traditional approaches.

[0132] The pre-positionable artificial bioprosthetic valve provided in this invention is not simply a matter of suturing the bioprosthetic leaflet 2 onto a novel stent. Instead, it utilizes the core structural feature of "strict matching of leaflet size with valve seat 12 in the second state," combined with the stent's controllable conversion capability, to create a complete technical solution integrating pre-positioned compression delivery, controllable balloon expansion, immediate normal opening and closing after expansion, three-point anchoring stability, reliable perivalvular sealing, and implantation of small valve annulus size enhancement. For surgeons, this simplifies intraoperative assembly and positioning, and shortens cardiopulmonary bypass time. For patients, especially those with small aortic valve annulus, it means a safer surgical procedure, better postoperative hemodynamics, lower risk of re-intervention, and a more optimistic long-term prognosis.

[0133] Based on the same inventive concept, this invention also provides a pre-positionable artificial bioprosthetic valve implantation system, as described above. Figures 13-28 As shown, the system includes: a valve holder 3, an artificial bioprosthetic valve delivery mechanism 4, and a pre-positionable artificial bioprosthetic valve as described in the above embodiment; the valve holder 3 is sutured to the pre-positionable artificial bioprosthetic valve; and the artificial bioprosthetic valve delivery mechanism 4 is connected to the valve holder 3.

[0134] It should be noted that during the production stage, the pre-positionable artificial bioprosthetic valve and valve holder 3 can be connected by sutures; during transportation and storage, the pre-positionable artificial bioprosthetic valve with valve holder 3 and the artificial bioprosthetic valve delivery mechanism 4 can be separately packaged and stored; during surgery, medical personnel install the pre-positionable artificial bioprosthetic valve with valve holder 3 onto the artificial bioprosthetic valve delivery mechanism 4. (Refer to...) Figure 17 As shown, the valve holder 3 is fitted onto the artificial bio-valve delivery mechanism 4 along the direction of arrow a.

[0135] In this embodiment, the valve holder 3 is sutured to a pre-positionable artificial bioprosthetic valve, and the valve holder 3 is detachably connected to the artificial bioprosthetic valve delivery mechanism 4. During balloon-assisted dilation, the valve holder 3 effectively constrains and limits the leaflet struts 111 (valve feet) of the valve frame 11, significantly inhibiting the outward deformation of the leaflet struts 111 during radial dilation, thus avoiding problems such as poor leaflet alignment or incomplete closure caused by deformation of the leaflet struts 111. At the same time, this connection method prevents the balloon from directly pressing on the leaflet 2 during dilation, reducing the risk of leaflet 2 damage. In addition, the detachable connection between the valve holder 3 and the artificial bioprosthetic valve delivery mechanism 4 facilitates rapid installation and removal during surgery, simplifies the operation process, and shortens the aortic clamping time. This improves the positioning accuracy and dilation stability of valve implantation while ensuring the reliability of the valve's opening and closing function after implantation.

[0136] In one embodiment, refer to Figures 13-16As shown, the valve holder 3 may include: three integrally formed connecting claws 31 and a first connecting seat 32; the end of the connecting claws 31 away from the first connecting seat 32 is provided with a suture hole 33; the valve holder 3 is connected to the suture of the covering 15 outside the leaflet support 111 of the valve frame 11 in the pre-positionable artificial bio-valve through the suture hole 33; the first connecting seat 32 is annular and is provided with an installation port 34 for connecting with the artificial bio-valve delivery mechanism 4.

[0137] In this embodiment, the valve holder 3 is directly sutured to the covering 15 outside the leaflet strut 11 of the valve frame 11 by the integrally formed connecting claw 31 and suture hole 33. This connection method can form a direct and stable circumferential constraint and axial traction on the leaflet strut 111 (foot) area during balloon-assisted dilation 410, effectively suppressing outward displacement or unexpected deformation of the foot caused by dilation force, thereby avoiding misalignment of the leaflet 2 due to strut deformation. At the same time, the quick and detachable connection between the annular first connecting seat 32 and its mounting port 34 of the valve holder 3 and the artificial bioprosthetic valve delivery mechanism 4 simplifies the intraoperative assembly and separation operations, and ensures the overall structural stability of the valve during delivery and positioning, significantly improving the controllability and efficiency of the surgical operation.

[0138] Compared to the existing technology where the connecting claw 31 of the valve holder 3 is connected at the midpoint between the two valve corners (i.e., the leaflet junction), the existing balloon 410 presses against the leaflet 2 during expansion, easily damaging the leaflet 2; and it does not adequately limit the valve corner itself, easily leading to valve corner deformation and incomplete leaflet closure. In this embodiment of the invention, the free end of the connecting claw 31 is connected to the covering 15 outside the leaflet support. When using the balloon 410 to assist in the expansion of a pre-positionable artificial bioprosthetic valve, this connection method can limit valve corner deformation, thereby protecting the leaflet 2 and ensuring its normal closure.

[0139] In one embodiment, refer to Figure 16 As shown, a marking platform 35 for marking valve size is provided on the periphery of the first connecting seat 32. This embodiment, by providing a marking platform 35 for marking valve size on the first connecting seat 32 of the valve holder 3, meets the need for rapid identification and confirmation of valve specifications during surgery. This facilitates doctors and operators to intuitively and accurately obtain the size information of the valve currently in use, avoiding implantation mismatch, repeated adjustments, or surgical delays caused by size confusion or misjudgment. This improves the precision and safety of the surgery, shortens the cardiopulmonary bypass time, and reduces the implantation risk caused by the uncertainty of manual operation.

[0140] In one embodiment, refer to Figures 17-28As shown, the artificial bioprosthetic valve delivery mechanism 4 may include: a connector 401, a first connector 402, a second connector 403, a spring 404, a handle 405, an outer tube 406, an inner tube 407, a third connector 408, a second connecting seat 409, and a balloon 410; the proximal end of the connector 401 is used to connect to a ram pump (not shown in the figure), and the distal end of the connector 401 is connected to the proximal end of the first connector 402; the connector 401 has a hollow structure, and a limiting boss 4011 is provided on the inner wall; the second connector 404... The connector 403 is nested inside the connector 401. A spring 404 is sleeved on the second connector 403, with its distal end connected to the second connector 403 and its proximal end limited by a limiting boss 4011. The proximal end of the handle 405 is inserted into the distal end of the first connector 402, and the distal end of the handle 405 is also inserted into the proximal end of the outer tube 406. The second connecting seat 409 is located in the distal region of the outer tube 406 and is detachably connected to the valve holder 3. The inner tube 407 is coaxially sleeved inside the outer tube 406. The proximal end of the inner tube 407 is inserted into the distal end of the first connector 402, and the distal end of the inner tube 407 is sealed to the proximal end of the balloon 410; the third connector 408 is coaxially sleeved inside the inner tube 407, the proximal end of the third connector 408 is inserted into the distal end of the second connector 403, and the distal end of the third connector 408 penetrates the balloon 410 and is sealed to the distal end of the balloon 410; a first channel 4034 is provided on the outer side of the second connector 403; a second channel 41 is formed between the first connector 402 and the third connector 408. 3; A third channel 414 is formed between the inner tube 407 and the third connector 408; physiological saline in the pump is injected into the balloon 410 through the first channel 4034, the second channel 413 and the third channel 414 to expand the pre-positionable artificial bioprosthetic valve from its original state to its normal use state; the central region of the balloon 410 is cylindrical in the expanded state; the height of the central region of the balloon 410 from the second connector 409 in the axial direction is consistent with the height of the valve holder 3 from the anchor seat 13 in the artificial bioprosthetic valve.

[0141] In this embodiment, the valve expansion process using the aforementioned artificial bioprosthetic valve delivery mechanism 4 is as follows: The pump injects saline solution into the balloon 410 through the connector 401, and the spring 404 is compressed during the balloon expansion process; during the process of withdrawing saline solution from the balloon 410, the spring 404 recovers its deformation, and the distal end of the balloon 410 receives a pulling force from the distal end of the third connector 408, causing the balloon 410 to flatten during the deflation process, preventing the balloon 410 from accumulating locally after expansion and compression, which would increase the diameter of the balloon 410 and ultimately affect the balloon 410's passage through the implanted pre-positionable artificial bioprosthetic valve. Since the central region of the balloon 410 is cylindrical in the expanded state, and the axial height of this cylindrical region from the second connecting seat 409 is consistent with the height of the valve holder 3 from the anchoring seat 13 in the artificial bio-valve, the anchoring seat 13 of the valve is precisely positioned within the cylindrical expansion region of the balloon 410 during expansion, thereby obtaining a uniform and stable radial expansion force. This ensures that the valve stent unfolds according to the preset shape and achieves reliable anchoring with the autologous valve annulus.

[0142] It should be noted that the distal end of the third connector 408 penetrates the balloon 410 and is sealed to the distal end of the balloon 410. The sealing connection can be achieved by welding.

[0143] In this embodiment, the artificial bioprosthetic valve delivery mechanism 4, through optimized fluid channel design and spring 404 buffer structure, achieves controllable injection of saline and smooth expansion of balloon 410. It can maintain axial stability and uniform radial deformation of the valve during expansion, effectively preventing local accumulation of balloon 410 after retraction, which would make it difficult to withdraw balloon 410. At the same time, through the precise connection between the valve holder 3 and the leaflet strut, it limits abnormal deformation of the valve angle during expansion, avoiding damage to the leaflet 2 and incomplete closure. Thus, while ensuring rapid and stable anchoring, it significantly improves surgical safety and valve reliability.

[0144] In one embodiment, refer to Figure 26 As shown, the second connecting seat 409 may include: a cap body 4091, a cylindrical body 4092 connected to the cap body 4091, and a circumferential protrusion 4093 disposed on the outer wall of the cylindrical body 4092; the outer diameter of the cylindrical body 4092 is smaller than the outer diameter of the cap body 4091, and the cylindrical body 4092 is provided with a plurality of slots 4094 that match the connecting claws 31 of the valve holder 3, and the opening direction of the slots 4094 is facing away from the cap body 4091; a snap-fit ​​portion 4095 is formed between the circumferential protrusion 4093 and the cap body 4091, and the axial height of the snap-fit ​​portion 4095 matches the axial height of the first connecting seat 32 in the valve holder 3.

[0145] In this embodiment, the second connecting seat 409 is provided with a slot 4094 with its opening direction facing away from the cap body 4091, so that the connecting claw 31 on the valve holder 3 can be stably and conveniently nested into the slot 4094 and form a reliable and rotatable connection with the locking part 4095; together with the axially limiting locking part 4095 formed by the circumferential protrusion 4093 and the cap body 4091, the axial movement of the valve holder 3 can be effectively restricted during delivery to prevent it from accidentally falling off or shifting, thereby improving the operational stability and repeatability of the entire implantation system, and helping to achieve precise alignment and smooth implantation during balloon 410 expansion and valve release.

[0146] In one embodiment, refer to Figure 19 and Figure 20 As shown, a first axial gap 411 is provided between the proximal end of the spring 404 and the limiting boss 4011. In this embodiment, by limiting the first axial gap 411, the spring 404 can be compressed to leave axial deformation space when physiological saline is injected into the balloon 410 to dilate the valve using a pump. Thus, when the physiological saline is withdrawn after dilation, the spring 404 can restore its deformation and apply tension to the distal end, causing the balloon 410 to flatten evenly during contraction. This avoids local accumulation of the balloon 410, which would lead to an increase in diameter, and ensures that the balloon 410 can be smoothly withdrawn from the dilated valve, improving the safety and reliability of the operation.

[0147] In one embodiment, refer to Figure 19 , Figure 21 and Figure 24 As shown, the distal end of the first connector 402 is provided with a stepped first connection hole 4021, and the proximal end of the inner tube 407 is inserted into the first connection hole 4021 and connected to the distal end of the first connector 402.

[0148] This embodiment achieves reliable insertion and accurate positioning of the proximal end of the inner tube 407 and the first connector 402 by setting a stepped first connecting hole 4021. This not only simplifies the assembly process but also ensures the sealing and continuity of the fluid channel, avoiding the risk of leakage during the expansion of the saline balloon 410, thereby improving the operational stability and reliability of the valve implantation system.

[0149] In one embodiment, refer to Figure 19 , Figure 24 and Figure 25 As shown, the proximal end of the second connector 403 is provided with a limiting post 4031 for sleeved spring 404, the distal end of the second connector 403 is provided with a second connecting hole 4032 for insertion into the proximal end of the third connector 408, and the outer surface of the second connector 403 is provided with a plurality of ridges 4033 distributed along the axial direction, and a first channel 4034 is formed between adjacent ridges 4033.

[0150] The structure of the second connector 403 described above in this embodiment has several advantages. First, the setting of the limiting post 4031 and the second connecting hole 4032 enables the spring 404 to be precisely positioned and effectively compressed in the axial direction. Combined with the insertion structure of the third connector 408, this ensures that the inner tube 407 of the artificial bio-valve delivery mechanism 4 experiences uniform force and stable movement during the expansion and contraction of the balloon 410, thereby avoiding wrinkles or accumulation of the balloon 410 due to uneven local force and ensuring the regularity of the valve expansion shape. Second, the first channel 4034 formed by the axial ridge 4033 provides a uniform and smooth flow path for the saline injected by the pump, which not only improves the fluid delivery efficiency but also helps maintain the pressure balance inside and outside the balloon 410, ensuring that the expansion process is controllable and stable, and ultimately improving the accuracy and safety of valve implantation.

[0151] In one embodiment, refer to Figure 19 , Figure 21 and Figure 22 As shown, the proximal end of the handle 405 is provided with a stepped third connection hole 4051 that is inserted into the distal end of the first connector 402, and the distal end of the handle 405 is provided with a stepped fourth connection hole 4052 that is inserted into the proximal end of the outer tube 406.

[0152] In this embodiment, the stepped insertion structure enables multi-level positioning and axial limiting, enhancing the structural stability and assembly precision of the artificial bioprosthetic valve delivery mechanism 4 during operation and preventing component displacement or detachment due to loose connections. Simultaneously, the stepped design facilitates alignment and sealing during assembly, ensuring the continuity and airtightness of the saline channel, and improving the control precision and safety of the balloon 410 expansion process. This ensures that the valve can be stably and accurately expanded to the preset state during implantation.

[0153] In one embodiment, refer to Figure 19 and Figure 23 As shown, the first connector 402 and the second connector 403 are threaded together, and a sealing ring 412 is provided between the first connector 402 and the second connector 403.

[0154] This embodiment achieves reliable mechanical fixation and axial alignment between the first connector 402 and the second connector 403 through a threaded connection, ensuring the stability and torsional resistance of the connection structure during the operation of the artificial bioprosthetic valve delivery mechanism. At the same time, the sealing ring 412 effectively prevents saline from leaking from the interface between the two connectors during the inflation of the balloon 410, ensuring the stable transmission and controllability of the balloon 410 expansion pressure, thereby improving the safety and operational reliability of the valve stent expansion process from its original state to its normal use state.

[0155] This invention provides a detailed description of the specific usage and implantation process of the pre-positionable artificial bioprosthetic valve implantation system. The pre-positionable artificial bioprosthetic valve implantation system provided by this invention integrates a pre-positionable artificial bioprosthetic valve, a valve holder 3, and an artificial bioprosthetic valve delivery mechanism 4. Its core design goal is to achieve rapid, stable, minimally invasive valve implantation with low complication rates. The implantation process of this system is described in detail below with reference to the accompanying drawings and clinical operating procedures:

[0156] (1) Preoperative preparation stage: Before the operation begins, the following preparations need to be completed:

[0157] Pre-connection of the valve to the valve holder 3: Under aseptic conditions, the pre-positionable prosthetic bioprosthetic valve is connected to the valve holder 3. Specifically, sutures are passed through the suture holes 33 at the distal end of the connecting claws 31 of the valve holder 3 and sutured to the covering 15 on the outer side of the leaflet support of the prosthetic bioprosthetic valve frame 11. This step is usually completed during the production process or operating room preparation, resulting in a pre-positionable prosthetic bioprosthetic valve assembly with the valve holder 3.

[0158] System Assembly: Install the pre-positionable artificial bioprosthetic valve assembly with valve holder 3 onto the artificial bioprosthetic valve delivery mechanism 4. The operator holds the handle 405 of the artificial bioprosthetic valve delivery mechanism 4 and aligns the cylinder 4092 of the distal second connecting seat 409 of the artificial bioprosthetic valve delivery mechanism 4 with the mounting port 34 of the first connecting seat 32 of the valve holder 3, along the axial direction (e.g., as shown in the instruction manual). Figure 18 Pushing the valve holder 3 in the direction indicated by the middle arrow a) causes the connecting claw 31 of the valve holder 3 to embed into the slot 4094 of the second connecting seat 409. Simultaneously, the first connecting seat 32 of the valve holder 3 engages with the engaging portion 4095 formed by the cap 4091 of the second connecting seat 409 and the circumferential protrusion 4093. At this point, the valve holder 3 and the artificial bioprosthetic valve delivery mechanism 4 are detachably engaged and can rotate relative to each other circumferentially, facilitating intraoperative adjustment of the valve direction.

[0159] Piping connection: Connect the connector 401 (pump connector 401) at the proximal end of the artificial bio-valve delivery mechanism 4 to the piping of the external pump, ensuring a secure and sealed connection.

[0160] (2) Valve delivery and positioning stage: After the system assembly is completed and the necessary surgical conditions such as cardiopulmonary bypass are established for the patient, the valve is delivered and positioned.

[0161] Establish delivery path: Based on the surgical approach (such as via aortic incision), the artificial bio-valve delivery mechanism 4 and the valve loaded at its front end are delivered into the target area of ​​the patient's aortic root.

[0162] Initial positioning: Under the guidance of imaging such as X-ray fluoroscopy or echocardiography, the artificial bioprosthetic valve delivery mechanism is slowly advanced so that the entire artificial bioprosthetic valve spans the patient's own diseased aortic valve annulus. The system position is adjusted to ensure that the valve anchor 13 and its three anchor blocks 14 are located on the ventricular side (i.e., below the valve annulus), while the valve seat 12 and valve frame 11 are partially located on the aortic side (i.e., above the valve annulus).

[0163] Precise alignment: The key step is to align the three anchor blocks 14 with the root of the three leaflet 2 junctions of the patient's own aortic valve annulus (i.e., the three physiological indentation positions). The medical staff can gently rotate the handle 405 of the artificial bioprosthetic valve delivery mechanism 4, which will rotate the valve holder 3 and the valve as a whole. By observing the markings on the valve (if any) or combining the anatomical landmarks in the imaging, the precise alignment of the anchor blocks 14 with the root of the leaflet 2 junctions can be achieved.

[0164] (3) Balloon 410 dilation and valve release stage: After the valve position is accurately adjusted, balloon 410 dilation is performed to change the valve from its "original state" to its "normal use state":

[0165] Inflation and expansion of balloon 410: The ram pump is activated to inject saline solution into the artificial bioprosthetic valve delivery mechanism 4. The saline solution flows sequentially through: the inside of connector 401, the first channel 4034 formed by the outer ridge 4033 of the second connector 403, the second channel 413 between the first connector 402 and the third connector 408, and the third channel 414 between the inner tube 407 and the third connector 408, finally entering and inflating balloon 410.

[0166] Valve morphology transformation: As the balloon 410 inflates and expands, its radial force acts on the pre-positionable artificial bioprosthetic valve fitted outside the balloon 410. During this process: the valve seat 12 (unidirectional, limitable expansion ring) expands radially under the pressure of the balloon 410. Due to its unique interlocking structure of the seat unit 121 (first rivet 122, limit protrusion 123, and the engagement of the elongated groove and the limit hole), this expansion is unidirectional and limitable. When expanded to the preset size (the normal operating size matching the selected valve model), the structure self-locks to prevent retraction, thereby forming a stable, fitted support ring on the aortic side, effectively sealing potential paravalvular leak channels. The anchor seat 13 expands and anchors simultaneously, causing the three anchor blocks 14 on it to move outward. Anchor block 14 is precisely pushed into and fitted into the root depression at the junction of the three leaflets 2 of the autologous valve annulus, forming a stable three-point mechanical anchor. This anchoring method avoids the continuous pressure on the valve annulus tissue caused by the circumferential expansion of traditional stents.

[0167] Leaflet 2 protection: Throughout the dilation process, the connecting claw 31 of the valve holder 3 is directly sutured to the covering 15 outside the leaflet support, effectively constraining and limiting the leaflet angles of the valve frame 11. This prevents the leaflet angles from excessively deforming or twisting outward under the pressure of the balloon 410, thereby protecting the leaflets 2 sutured to the valve frame 11 from damage and ensuring that the leaflets 2 can properly align after dilation, avoiding incomplete closure.

[0168] Balloon 410 decompression and repositioning: After confirming that the valve is fully dilated and stably anchored, the pressure pump is operated to aspirate saline, causing the balloon 410 to depressurize and contract. During this process, the spring 404 sleeved on the second connector 403 plays a role: the spring 404, which is compressed during the inflation and expansion of the balloon 410, recovers its deformation during decompression. Its restoring force is transmitted through the second connector 403 and the third connector 408, applying an axial tension to the distal end of the balloon 410. This tension helps the balloon 410 to contract evenly and smoothly, avoiding local wrinkles or accumulation of the balloon 410 material, ensuring that the outer diameter of the contracted balloon 410 is small, allowing it to be smoothly withdrawn from the inside of the expanded and fixed artificial bioprosthetic valve without interfering with or moving the implanted valve.

[0169] (4) Withdrawal of artificial bioprosthetic valve delivery device

[0170] Valve holder 3 separation: After the balloon 410 is fully contracted and the valve position and function are confirmed to be good, the suture connecting the valve holder 3 connecting claw 31 and the leaflet support covering 15 is cut.

[0171] System Removal: Carefully withdraw the artificial bioprosthetic valve delivery mechanism 4, together with the valve holder 3, along the delivery path from the patient's body. The valve holder 3 disengages from the locking portion 4095 of the second connector 409, completing the separation. At this point, the pre-positionable artificial bioprosthetic valve has been successfully implanted and fixed in the patient's aortic valve annulus.

[0172] (5) Postoperative effects

[0173] Through the above-described implantation process, the present invention achieves the following clinical advantages:

[0174] Rapid anchoring: Three-point anchoring is performed using the physiological structure at the root of the leaflet 2 junction, which significantly shortens the time required for traditional suturing and reduces cardiopulmonary bypass time and related risks.

[0175] Stable fixation and low paravalvular leakage: The active expansion of the upper valve seat 12 fits tightly against the valve annulus, and together with the three-point anchoring at the bottom, it provides excellent initial fixation force and sealing, effectively reducing the incidence of paravalvular leakage.

[0176] Reduced complications: By avoiding the circumferential high-pressure expansion of the annular stent, the stimulation and compression of the cardiac conduction system and surrounding tissues are reduced, which helps to reduce postoperative arrhythmia complications such as palpitations, conduction block, and bradycardia.

[0177] Leaflet 2 protection function: The unique valve holder 3 connection method protects the leaflet 2 structure during expansion, ensuring normal opening and closing function after valve implantation.

[0178] Suitable for small aortic valve annulus: Allows for the implantation of relatively larger valves (achieved through balloon 410 expansion), improves the effective ostium area, helps alleviate patient-prosthetic valve mismatch, and is particularly beneficial for patients with small aortic valve annulus.

[0179] The prepositionable artificial bioprosthetic valve implantation system provided in this embodiment of the invention is a complete surgical solution integrating a prepositionable artificial bioprosthetic valve, a valve holder 3, and an artificial bioprosthetic valve delivery mechanism 4. The coordinated operation of all components of the system enables safe, precise, and efficient operation of the valve throughout the entire process from preparation and delivery to anchoring and release. Its specific beneficial effects are as follows:

[0180] I. Advantages of System Integration: Achieving Optimization and Control of the Entire Process

[0181] The core value of this system lies in combining innovative valve products with specially designed delivery tools to create a seamless clinical workflow. This systematic design not only leverages the structural advantages of the valve but also ensures that these advantages are perfectly realized during surgery through innovative tools, solving the critical transformation from "excellent product" to "successful implantation."

[0182] II. A detailed description of the core beneficial effects

[0183] (1) Achieve precise, controllable and stable valve delivery and release

[0184] The key pivotal role of valve holder 3:

[0185] A reliable connection method: The valve holder 3 is directly sutured to the covering 15 outside the leaflet support of the valve frame 11 via its connecting claw 31. Compared with existing technologies (such as connecting at the junction of the leaflets 2), this connection method provides a more direct and stronger constraint on the valve angle when the balloon 410 expands.

[0186] Effective protection of leaflet 2: Under the above connection method, the radial force of balloon 410 during expansion is evenly distributed through valve holder 3, which effectively prevents excessive outward extension or deformation of leaflet support, thereby avoiding incomplete closure of leaflet 2 due to leaflet angle deformation, and also avoiding damage caused by balloon 410 directly pressing against leaflet 2.

[0187] Rotatable positioning: The valve holder 3 and the second connecting seat 409 of the artificial biological valve delivery mechanism 4 are engaged by a snap-fit, allowing the surgeon to easily rotate the entire valve assembly according to anatomical landmarks during delivery, so that the three anchor blocks 14 are precisely aligned with the root of the junction of the three leaflets 2 of the autologous valve annulus, achieving anatomical adaptation and anchoring.

[0188] Optimized design of artificial bioprosthetic valve delivery mechanism 4:

[0189] A clear three-channel fluid system: The design of the first channel 4034, the second channel 413, and the third channel 414 ensures that the flow path of physiological saline from the pump to the balloon 410 is smooth and controllable, and the pressure is accurately transmitted. This is the basis for achieving stable and uniform expansion of the balloon 410.

[0190] Spring 404 Reset Mechanism: A spring 404 is installed on the second connector 403, with a first axial gap 411 reserved. This design allows the balloon 410 to receive an axial tension from the distal end when it contracts (depressurizes). This tension causes the balloon 410 to flatten and retract evenly, effectively preventing local accumulation and wrinkling of the balloon 410 material, and avoiding an increase in diameter due to poor balloon retraction. This ensures that the balloon 410 can be safely and smoothly withdrawn from the already expanded and fixed valve, preventing disturbance to the implanted valve.

[0191] Modular design and sealing: The various connectors (such as the first connector 402 and the second connector 403) are connected by threaded connections with sealing rings 412, and the handle 405 adopts a stepped insertion hole, which ensures the structural rigidity, operational stability and sealing of the fluid channel of the system, prevents intraoperative leakage and ensures the safety and reliability of the operation.

[0192] (2) It greatly simplifies the surgical procedure and significantly shortens the cardiopulmonary bypass time.

[0193] "Ready-to-use" rapid preparation: The valve and valve holder 3 are pre-connected before or off-site during the operation. During the operation, the surgeon only needs to simply insert the valve holder 3 into the second connector 409 of the artificial bioprosthetic valve delivery mechanism 4 to complete the system assembly, eliminating the time-consuming steps such as cumbersome valve loading and valve testing in traditional surgery.

[0194] Rapid anchoring instead of sutures: The system is designed to support sutureless or rapid valve deployment. Once the valve is accurately positioned, anchoring and sealing can be completed within minutes by balloon 410 dilation, replacing the most time-consuming valve annulus suturing step in traditional surgery.

[0195] Reduced cardiac arrest time: The simplification of the above procedures directly leads to a significant reduction in aortic clamping time and cardiopulmonary bypass time. This reduces the risk of systemic complications associated with prolonged cardiopulmonary bypass, such as inflammatory responses, coagulation disorders, and kidney damage, which is particularly beneficial for elderly and high-risk patients.

[0196] (3) Ensure and enhance the final effect of valve implantation

[0197] Ensuring a high anchoring success rate: The system's rotatable design and clear valve / valve holder 3 structure allow the operator to intuitively and accurately align the anchor block 14 with the physiological depression under image guidance, improving the success rate and stability of three-point anchoring and reducing the risk of anchoring failure or paravalvular leakage due to inaccurate alignment from an operational perspective.

[0198] Ensuring valve function: As mentioned earlier, the valve holder 3's protection mechanism for the valve angle is crucial to ensuring that the leaflet 2 can open and close normally after implantation, preventing insufficiency. This function of the system directly translates the advantages of the product design into good valve function for the patient after surgery.

[0199] Enhancing surgical safety: The spring 404 reset mechanism prevents the risk of difficulty in withdrawing the balloon 410; the reliable sealing design prevents fluid leakage; and the overall system stability reduces unexpected events during the procedure. These designs collectively improve the safety margins of the entire implantation process.

[0200] (4) Provide surgeons with an excellent operating experience and controllability

[0201] Ergonomically designed: The 405 handle is easy to grip and operate, and the force is transmitted directly.

[0202] The operation steps are intuitive: assembly, delivery, rotation, expansion, and withdrawal are clearly defined, reducing the learning curve.

[0203] The feedback was clear: the pressure of balloon 410 dilation was controllable, the valve self-locked through valve seat 12 after dilation, and the valve holder 3 was reliably connected, giving the surgeon clear feedback and enhancing the confidence and controllability of the surgery.

[0204] (5) Particularly suitable for minimally invasive and complex anatomical scenarios

[0205] Suitable for small incision surgery: The entire system is compact in design and the operation steps are simplified, making it very suitable for surgery through minimally invasive suprasternal incision or right anterior chest incision, thus promoting the minimally invasive development of aortic valve replacement surgery.

[0206] Addressing the challenges of small aortic valve annulus: This system is a key tool for realizing the clinical strategy of "implanting a larger valve for a small annulus." Its delivery and controlled expansion capabilities make it possible to safely implant a larger pre-positioned valve without enlarging the root.

[0207] The pre-positionable artificial bioprosthetic valve implantation system provided in this invention is a meticulously designed, integrated solution combining instrumentation and workflow. It is not merely a delivery tool, but a key enabling system that ensures the safe, precise, and repeatable translation of innovative valve design concepts into clinical efficacy. Through the valve holder 3's valve angle protection and rotational positioning functions, and the artificial bioprosthetic valve delivery mechanism 4's controllable hydrodynamics and safe withdrawal mechanism, this system successfully addresses common operational risks in rapid valve deployment applications, such as leaflet 2 injury, inaccurate anchoring, and difficulty in withdrawing the balloon 410. Ultimately, this system enables surgeons to complete aortic valve replacement surgery, especially for patients with small aortic annulus valves, with less time, less trauma, higher controllability, and greater safety, ultimately allowing patients to benefit from better implantation outcomes and better postoperative recovery.

[0208] Based on the same inventive concept, this embodiment of the invention also provides an application of the above-mentioned artificial bio-valve stent 1 in a pre-positionable artificial bio-valve implantation system.

[0209] In this embodiment, the artificial bioprosthetic valve stent 1 is applied in a pre-positionable artificial bioprosthetic valve implantation system. By combining the artificial bioprosthetic valve stent 1 with three anchoring blocks 14 with the artificial bioprosthetic valve delivery mechanism 4, stable anchoring can be achieved during surgery without traditional suture operations, significantly shortening cardiopulmonary bypass time and reducing surgical trauma. The stent is precisely anchored at the root of the junction of the three leaflets 2 of the autologous valve annulus through the anchoring blocks 14. At the same time, the unidirectionally expandable valve seat 12 enhances the seal, effectively reducing the risk of paravalvular leakage and postoperative complications such as conduction block and arrhythmia, thus improving the safety and long-term efficacy of implantation. The specific implementation and beneficial effects of this application can be referred to in the detailed description of the artificial bioprosthetic valve stent 1 described above, and will not be repeated here.

[0210] Based on the same inventive concept, this embodiment of the invention also provides an application of the above-mentioned prepositionable artificial biovalve in a prepositionable artificial biovalve implantation system.

[0211] In this embodiment, the application of the prepositionable artificial bioprosthetic valve in the prepositionable artificial bioprosthetic valve implantation system, through the coordinated operation of the artificial bioprosthetic valve with the artificial bioprosthetic valve delivery mechanism 4 and the valve holder 3, achieves further optimization of its clinical operation performance and long-term stability while retaining the advantages of the original prepositioned valve structure. Specifically, the prepositionable artificial bioprosthetic valve is anchored at the root of the junction of the three leaflets 2 of the autologous valve annulus by three anchoring blocks 14, and combined with the unidirectional limiting expansion structure of the valve seat 12, effectively avoiding conduction block and paravalvular leakage problems caused by traditional circumferential expansion; at the same time, with the help of the valve holder 3 designed in the artificial bioprosthetic valve delivery mechanism 4, the suture connection between the valve holder 3 and the leaflet support covering 15, the optimization of the balloon 410 drainage channel, and the spring 404 reset mechanism, the positioning accuracy during valve expansion, the protection of the leaflet 2, and the postoperative morphological stability are ensured. This application significantly shortens the operation time and reduces the risks of cardiopulmonary bypass, making it particularly suitable for minimally invasive treatment of patients with small aortic valve annulus. It also reserves structural space for potential subsequent valve-in-valve intervention, achieving a synergistic effect of rapid anchoring, reduced complications, and improved hemodynamics. The specific implementation and beneficial effects of this application can be found in the detailed description of the pre-positionable artificial bioprosthetic valve described above; further details are omitted here.

[0212] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. This disclosure is not limited to the precise structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. Thus, if these modifications and variations of the invention fall within the scope of the invention's equivalents, the invention is also intended to include these modifications and variations.

Claims

1. An artificial bioprosthetic valve stent, characterized in that, include: The petal frame, petal seat, anchor seat, and three anchor blocks fitted onto the anchor seat; The valve frame has three leaflet supports; the valve seat is an annular metal seat, the valve frame is embedded above the valve seat and is stitched to the valve seat through a covering; the anchor is a balloon-expandable annular metal seat, the anchor is located on the side opposite to the valve frame and is stitched to the valve seat through a covering; the three anchor blocks correspond to the positions of the three leaflet supports in the valve frame; The artificial bio-valve stent has a first state and a second state; In the first state, the area where the anchoring block is located is concave in the radial direction of the anchoring seat, and the outer diameter of the circle containing the outer edges of the three anchoring blocks is smaller than the outer diameter of the petal seat; in the second state, the anchoring seat is annular, and the outer diameter of the circle containing the outer edges of the three anchoring blocks is larger than the outer diameter of the petal seat.

2. The artificial bioprosthetic valve stent according to claim 1, characterized in that, The valve seat is a unidirectional, expandable, ring-shaped metal seat; In the first state, the outer diameter of the valve seat is smaller than that in the second state; In the first state, the ratio of the outer diameter of the petal seat to the outer diameter of the anchor seat is 1.04:1 to 1.1:1; In the second state, the ratio of the outer diameter of the petal seat to the outer diameter of the anchor seat is 1:

1.

3. The artificial bioprosthetic valve stent according to claim 1, characterized in that, The length of the anchor block along the circumferential direction of the anchor seat is 5-7 mm; the width of the anchor block along the radial direction of the anchor seat is 4-6 mm; and the height of the anchor block perpendicular to the length and width directions is 4-7 mm.

4. The artificial bioprosthetic valve stent according to claim 3, characterized in that, Along the radial direction of the anchor seat, the width of the anchor block located outside the anchor seat accounts for 15% to 20% of the total width of the anchor block.

5. The artificial bioprosthetic valve stent according to claim 3, characterized in that, In the second state, the ratio of the outer diameter of the petal seat to the outer diameter of the circle containing the outer edges of the three anchor blocks is 1:1.1 to 1:1.

3.

6. The artificial bioprosthetic valve stent according to any one of claims 1 to 5, characterized in that, The positions of the three anchor blocks can be adjusted in the preset circumferential areas on the anchor seats.

7. The artificial bioprosthetic valve stent according to any one of claims 2 to 5, characterized in that, The petal seat is composed of several overlapping and interconnected base units. The first end of each base unit is provided with a first rivet, a limiting protrusion, and a first elongated groove from the outside to the inside. The last end of each base unit is provided with a second elongated groove that mates with the first rivet at the first end of the adjacent base unit, a second limiting hole and a first limiting hole that mate with the limiting protrusion, and a second rivet that mates with the first elongated groove. The first elongated groove of each base unit mates with the second rivet of the adjacent base unit and can move in one direction. The second elongated groove of each base unit mates with the first rivet of the adjacent base unit and can move in one direction. The limiting protrusion of each base unit can move in one direction in the first limiting hole and the second limiting hole of the adjacent base unit, respectively.

8. A pre-positionable artificial bioprosthetic valve, characterized in that, include: Three leaflets and an artificial bioprosthetic valve stent as described in any one of claims 1 to 7; The three leaflets are stitched to the three leaflet supports in the valve frame; the dimensions of the three leaflets match the dimensions of the valve seat in the second state.

9. A pre-positionable artificial bioprosthetic valve implantation system, characterized in that, include: Valve holder, artificial bioprosthetic valve delivery mechanism, and the pre-positionable artificial bioprosthetic valve as described in claim 8; The valve holder is sutured to the pre-positionable artificial bioprosthetic valve; The artificial bioprosthetic valve delivery mechanism is connected to the valve holder.

10. The pre-positionable artificial bioprosthetic valve implantation system according to claim 9, characterized in that, The valve holder includes: three integrally formed connecting claws and a first connecting seat; The connecting claw has a suture hole at one end away from the first connecting seat; the valve holder is connected to the suture of the covering material outside the leaflet support of the valve frame in the pre-positionable artificial bio-valve through the suture hole. The first connector is ring-shaped and has an installation port for connecting to the artificial bio-valve delivery mechanism.

11. The pre-positionable artificial bioprosthetic valve implantation system according to claim 10, characterized in that, The periphery of the first connector is provided with a marking platform for marking valve size.

12. The application of an artificial bioprosthetic valve stent as described in any one of claims 1 to 7 in a pre-positionable artificial bioprosthetic valve implantation system.

13. The application of the prepositionable artificial bioprosthetic valve as described in claim 8 in a prepositionable artificial bioprosthetic valve implantation system.

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