Expandable sutureless valve

Abstract

The application provides an expandable suture-free valve, and relates to the field of medical devices, which comprises a valve frame, a valve and a sealing ring; the valve frame comprises a plurality of overlapping units and a plurality of sets of limiting structures, the plurality of overlapping units are sequentially and end-to-end overlapped along the circumference to form an annular structure; each overlapping unit comprises a grid part, an overlapping part I and an overlapping part II; the overlapping part I and the overlapping part II of each two adjacent overlapping units are overlapped and matched inside and outside and are limited by the limiting structures; the limiting structures allow the two to relatively slide along the circumference of the annular structure until being self-locked at a certain relative position under the action of an external force which expands the annular structure along the radial direction from inside to outside, so as to expand and lock the radial dimension of the annular structure. The expandable suture-free valve can be secondarily expanded by a balloon after being implanted at a target position, so that the problem of the narrow valve orifice area of the newly implanted valve is effectively improved, and the symptom improvement effect after the operation is ensured and the long-term survival rate of the patient is improved.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and in particular to an expandable sutureless flap. Background Technology

[0002] Aortic stenosis (AS) is one of the most common heart valve diseases in the elderly, and the choice of treatment depends mainly on the patient's age and surgical risks.

[0003] (1) Surgical valve repair: For young and low-risk patients, conventional surgical aortic valve replacement (SAVR) is the standard treatment. This surgery requires the removal of the diseased valve and precise suturing of the artificial valve through open-chest surgery under cardiac arrest and cardiopulmonary bypass support. Although the effect is certain, the surgery is highly invasive and time-consuming.

[0004] (2) Using interventional valves: For elderly or high-risk patients, transcatheter aortic valve replacement (TAVR) is the preferred procedure due to its minimally invasive nature. However, this technique cannot completely remove calcified lesions and has limitations in terms of the accuracy and durability of interventional valve positioning.

[0005] (3) Using traditional “sutureless valve”: With the development of TAVR technology, a new type of surgical valve has emerged – “sutureless valve”. It uses multiple composite anchoring mechanisms to replace the traditional suture valve, which relies on sutures to fix the valve in the appropriate position. By avoiding circular sutures, the operation time is shortened, and more importantly, the ischemic time is shortened. In addition, the operation is usually performed under direct vision, which reduces the difficulty of the operation. However, clinical observations have revealed that regardless of which type of valve is used, the "artificial valve-patient mismatch" (PPM) phenomenon may occur after valve implantation. This phenomenon manifests as a persistent increase in transvalvular pressure gradient and insufficient effective valve orifice area after surgery, affecting the improvement of symptoms. In particular, when the bioprosthetic valve reaches the decay stage and requires intervention again, the effective orifice area of ​​the newly implanted valve will further shrink, leading to more severe hemodynamic disturbances and reducing the long-term survival rate of patients. This effect is particularly pronounced in patients with small aortic valve annulus (usually defined as annulus area ≤430mm²). Summary of the Invention

[0006] The purpose of this invention is to provide an expandable sutureless flap to alleviate the aforementioned technical problems in the prior art.

[0007] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions: This invention provides an expandable sutureless valve, comprising a valve frame, a valve membrane fixedly connected to the valve frame, and a sealing ring sleeved and fixedly connected to the proximal exterior of the valve frame; The petal frame includes multiple overlapping units and multiple sets of limiting structures; Multiple overlapping units are sequentially overlapped end to end along the circumferential direction to form a ring structure; each overlapping unit includes a grid portion and overlapping portion one and overlapping portion two respectively connected to opposite sides of the grid portion; in each pair of adjacent overlapping units, overlapping portion one of one overlapping unit and overlapping portion two of another overlapping unit overlap and cooperate in the radial direction of the ring structure to form an inner overlapping portion and an outer overlapping portion that overlap inside and outside; Each set of overlapping inner and outer layer overlaps is limited by a set of limiting structures; the limiting structures are configured to prevent the overlapping inner and outer layer overlaps from separating from each other, and to allow the inner and outer layer overlaps to slide relative to each other along the circumference of the annular structure until they self-lock at a certain relative position when the annular structure is subjected to an external force that expands radially from the inside to the outside, thereby expanding and locking the radial dimension of the annular structure.

[0008] In an optional implementation, in each set of overlapping inner and outer layers: The limiting structure includes at least two limiting holes provided in the outer layer overlap and at least two elastic buckle strips provided on the outer peripheral surface of the inner layer overlap, with one end of the elastic buckle strip curving outward along the radial direction of the annular structure to form a buckle end; All of the limiting holes are arranged at intervals along the circumference of the annular structure, and all of the elastic buckle strips are arranged at intervals along the circumference of the annular structure; When the inner and outer overlapping portions are locked in a certain relative position, at least one of the elastic buckle strips snaps into or passes through the corresponding limiting hole.

[0009] In an optional embodiment, the snap-fit ​​end includes an extension section one; one end of the extension section one is fixedly connected or integrally connected to the outer peripheral surface of the inner layer overlap portion, and the radial distance between the extension section one and the outer peripheral surface of the inner layer overlap portion gradually increases from the end of the extension section one connected to the inner layer overlap portion to the other end of the extension section one.

[0010] In an optional embodiment, the snap-fit ​​end further includes an extension section two; One end of the second extension segment is integrally connected to the end of the first extension segment away from the second overlapping portion; The second extension segment is parallel to the outer peripheral surface of the inner layer overlap portion, or the radial distance between the second extension segment and the outer peripheral surface of the inner layer overlap portion gradually decreases from the end where the second extension segment connects to the first extension segment to the other end of the second extension segment.

[0011] In an optional implementation, the second extension segment and the first extension segment are connected by a circular arc transition.

[0012] In an optional implementation, in each set of overlapping inner and outer layers: The limiting structure also includes a guide hole one provided in the inner layer overlap, a guide hole two provided in the outer layer overlap, and a limiting fastener assembled in the guide hole one and the guide hole two; Both the first guide hole and the second guide hole extend circumferentially along the annular structure; The limiting fastener includes a central connecting rod and limiting heads connected to both ends of the central connecting rod; along the radial direction of the annular structure: the central connecting rod passes through the first guide hole and the second guide hole, one of the limiting heads is limited to the inner side of the inner layer overlap, and the other limiting head is limited to the outer side of the outer layer overlap, and the central connecting rod can slide within the first guide hole and the second guide hole along the circumference of the annular structure.

[0013] In an optional embodiment, in each set of overlapping inner and outer layers, along the radial direction of the annular structure: The limiting head of the limiting fastener located on the inner side of the inner layer overlap has its side surface facing the inner layer overlap and is in contact with the inner circumferential surface of the inner layer overlap; the limiting head of the limiting fastener located on the outer side of the outer layer overlap has its side surface facing the outer layer overlap and is in contact with the outer circumferential surface of the outer layer overlap.

[0014] In an optional embodiment, the two side walls of each of the guide hole one and the guide hole two extending circumferentially along the annular structure are planar side walls. The circumferential surface of the central connecting rod has a first plane and a second plane arranged opposite to each other; the first plane slides in cooperation with the sidewall of the plane located on the same side of the first guide hole and the second guide hole; the second plane slides in cooperation with the sidewall of the plane hole located on the other side of the first guide hole and the second guide hole.

[0015] In an alternative embodiment, the body of the sealing ring is made of an elastomer; and / or, a plurality of exposed stitching coils are provided circumferentially on the sealing ring.

[0016] In particular, in the embodiments of the present invention, "and / or" means that the first feature before "and / or" and the second feature after "and / or" include the following specific settings: (1) only the first feature is set, and the second feature is not set; (2) only the second feature is set, and the first feature is not set; (3) the first feature and the second feature are set at the same time.

[0017] The embodiments of the present invention can achieve at least the following beneficial effects: In this embodiment of the invention, the expandable sutureless valve has at least four forms: natural form, first form, second form, and third state. The first form is the state after the valve frame is radially compressed; the second state is the stable working state after the valve frame is radially expanded to the required radial size; and the third state is the state after secondary expansion. The process of the expandable sutureless valve from its natural form to its first form needs to be carried out at a certain temperature / temperature range (e.g., 0°C-8°C) below the phase transition temperature, during which the valve is radially contracted to a certain size along with the valve frame. The process of the expandable sutureless valve from its first form to its second form can be carried out at a certain temperature (e.g., body temperature) after the expandable sutureless valve is implanted into the patient and the radial restraint on the valve frame is released. The valve then expands to its second form along with the valve frame. At this time, the sealing ring is placed on the original valve annulus, and the lower part of the sealing ring is compressed by the original valve annulus to form a stable working state slightly smaller than the natural form size of the valve frame, providing the valve with a certain degree of radial support and sealing capability. The transition from the second to the third stage occurs after the failure of the initially implanted expandable sutureless valve, during which a new valve is implanted into the expandable sutureless valve a second time. This is achieved by inserting a balloon into the valve frame of the initially implanted expandable sutureless valve, which is then used to expand the valve frame a second time. Ultimately, the annular structure of the valve frame is expanded to a larger radial dimension, and the radial dimension of the annular structure is locked by the aforementioned limiting structure. At this point, a new valve of a larger size is implanted into the expanded valve frame a second time, effectively improving the problem of narrowing of the valve orifice area after the new valve is implanted, ensuring the improvement of postoperative symptoms and improving the long-term survival rate of patients.

[0018] During the surgery, a minimally invasive aortic valve replacement is performed under visual guidance, combined with cardiopulmonary bypass. First, the original aortic valve leaflets and calcified tissue are removed. Then, the expandable sutureless valve is radially compressed and inserted into the sheath of the delivery system outside the body. The expandable sutureless valve changes from its natural shape to its first radially compressed shape. Next, under direct vision, the tip of the delivery system sheath is placed at the aortic valve annulus, and the expandable sutureless valve is released. After release, the valve expands along with the valve frame from its first shape to its second shape, where the sealing ring adheres to the original valve annulus, and the valve can then begin to function normally. When the initially implanted valve reaches the end of its service life and requires a replacement valve, a balloon is used to expand the initially implanted valve again. The circumference and radial dimensions of the expandable sutureless valve will increase, and the valve will change from its second shape to its third shape along with the valve frame. This ensures that the newly implanted valve can have a larger circumference and radial dimensions, effectively improving the problem of narrowing of the valve orifice area after the second implantation and improving the treatment effect.

[0019] In summary, compared with the prior art, the expandable sutureless flap provided in this embodiment can achieve at least the following beneficial effects: (1) Compared with the treatment method of surgically suturing the valve in the prior art, the surgery using the expandable sutureless valve provided in this embodiment is less traumatic (belonging to the type of minimally invasive surgery), which can reduce patient damage. At the same time, since it does not require full valve annulus suturing, it can reduce operation time, reduce cardiopulmonary bypass time, and reduce the learning curve for doctors. (2) Compared with the treatment method using interventional valves in the prior art, the use of the expandable sutureless valve provided in this embodiment can remove the original calcified valve leaflets, improve the surgical effect, and the surgery is completed under visual observation, making the operation easier and avoiding radiation hazards. (3) Compared with the treatment method using traditional sutureless flaps in the prior art, the expandable sutureless flap provided in this embodiment can be used for surgery. When the expandable sutureless flap is radially compressed (the first state mentioned above), the size that can be radially compressed is smaller, which can increase the field of vision during the operation and make it easier for doctors to operate. (4) In the prior art, when the first implanted valve reaches the end of its service life, a new valve needs to be implanted into the patient. Regardless of whether the first implanted valve is a surgically sutured valve, an interventional valve, or a traditional sutureless valve, the radial dimension of the second implanted valve is usually slightly smaller than that of the first implanted valve; otherwise, it would be difficult to operate with the existing implantation methods. However, the smaller effective opening area of ​​the second implanted valve will affect the postoperative effect, not only affecting the improvement of symptoms but also leading to more serious hemodynamic disorders and reducing the patient's long-term survival rate. When the expandable sutureless valve provided in this embodiment is implanted for the first time, if the valve fails, its frame can be expanded outward with a balloon to increase the circumferential length and radial dimension of the valve. Then, a new valve is implanted into the frame. As a result, the new valve implanted in the second implantation has a larger circumference and radial dimension than the new valves that can be implanted with existing technology, so as to effectively improve the problem of narrowing of the valve orifice area of ​​the newly implanted valve, ensure the improvement of postoperative symptoms and improve the long-term survival rate of patients. Attached Figure Description

[0020] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0021] Figure 1 Anatomical diagram of the human heart structure Figure 1 ; Figure 2 Anatomical diagram of the human heart structure Figure 2 ; Figure 3 Anatomical diagram of the human heart structure Figure 3 ; Figure 4 A schematic diagram of the overall structure of the expandable sutureless flap provided in an embodiment of the present invention. Figure 1 ; Figure 5 A schematic diagram of the overall structure of the expandable sutureless flap provided in an embodiment of the present invention. Figure 2 ; Figure 6 A schematic diagram of the overall structure of the expandable sutureless flap provided in an embodiment of the present invention. Figure 3 ; Figure 7 A schematic diagram of the combined structure of the expandable sutureless valve frame and valve provided in an embodiment of the present invention. Figure 1 ; Figure 8 A schematic diagram of the combined structure of the expandable sutureless valve frame and valve provided in an embodiment of the present invention. Figure 2 ; Figure 9 for Figure 8 A cross-sectional view of the structure in the first locked state along line AA; Figure 10 for Figure 9 A schematic diagram of the local structure of region B1 in the middle; Figure 11 for Figure 8 A cross-sectional view of the structure in the second locked state along line AA; Figure 12 for Figure 11 A schematic diagram of the local structure of region B2 in the middle; Figure 13 A schematic diagram of an optional structure of the elastic snap strip in the expandable sutureless flap provided in an embodiment of the present invention; Figure 14 A schematic diagram of another optional structure of the elastic snap-fit ​​strip in the expandable sutureless flap provided in the embodiments of the present invention; Figure 15 A schematic diagram of the overall structure of the overlapping unit of the flap frame in the expandable sutureless flap provided in an embodiment of the present invention; Figure 16 A schematic diagram of the cooperative structure of the overlapping part one, overlapping part two, guide hole one, guide hole two and limiting fastener in the expandable sutureless flap provided in the embodiment of the present invention; Figure 17 A schematic diagram of the component structure of the limiting fastener in the expandable sutureless flap provided in the embodiments of the present invention. Figure 1 ; Figure 18A schematic diagram of the component structure of the limiting fastener in the expandable sutureless flap provided in the embodiments of the present invention. Figure 2 .

[0022] Icons: 1-Valve frame; 2-Valve; 3-Overlap unit; 31-Overlap section one; 32-Overlap section two; 33-Grid section; 34-Inner overlap section; 35-Outer overlap section; 41-Limiting hole; 42-Elastic buckle strip; 421-Buckling end; 4211-Extension section one; 4212-Extension section two; 51-Guide hole one; 52-Guide hole two; 53-Limit fastener; 531-Middle connecting rod; 532-Limit head; 6-Sealing ring; 61-Sealing coil. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0024] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0025] It should be noted that similar labels and letters in the accompanying drawings indicate similar items. Therefore, once an item is defined in one accompanying drawing, it does not need to be further defined and explained in subsequent accompanying drawings.

[0026] In the description of this invention, it should be noted that: Unless otherwise explicitly specified and limited, the terms "set," "install," and "connect" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal 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.

[0027] The terms “proximal end,” “distal end,” “front end,” “rear end,” “axial,” “radial,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is usually placed during use. They are used only for the convenience of describing the 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. Therefore, they should not be construed as limiting the invention.

[0028] The terms “first”, “second”, etc. are used only for distinguishing descriptions and do not indicate totality or relative position in time and / or space, nor should they be construed as indicating or implying relative importance.

[0029] The following describes some embodiments of the present invention in detail with reference to the accompanying drawings.

[0030] like Figures 1 to 3 As shown, the human heart consists of four chambers: the left atrium, left ventricle, right atrium, and right ventricle. Each atrium is connected to one of the two ventricles, and each ventricle is connected to one of the two aortas. Heart valves grow between the atria and ventricles, and between the ventricles and aortas, acting as one-way valves to ensure unidirectional blood flow and prevent backflow, playing a crucial role in maintaining normal heart function.

[0031] The aortic valve is located between the left ventricle and the ascending aorta. During cardiac systole, the opening of the aortic valve allows blood ejected from the left ventricle to enter the ascending aorta through the aortic valve orifice, and then into the systemic arterial system. The aortic valve consists of three semilunar leaflets: the left leaflet, the right leaflet, and the posterior leaflet. Behind each leaflet, the aortic wall bulges outward, forming the aortic sinus. When the valve is normally shaped, the three leaflets meet towards the center along their junctional margins, supporting the blood column within the aorta and preventing backflow into the left ventricle. During ventricular systole, the upward rush of blood pushes the aortic valve leaflets away from the center of the aortic lumen; during ventricular diastole, the leaflets passively descend back into the center of the aortic lumen.

[0032] Based on this, this embodiment provides an expandable sutureless flap. After it is implanted into the patient's body, the inflow end of the blood flow is its proximal end, and the outflow end of the blood flow is its distal end.

[0033] Reference Figures 4 to 8 The expandable sutureless flap includes a valve frame 1, a valve membrane 2 fixedly connected to the valve frame 1, and a sealing ring 6 fitted and fixedly connected to the proximal exterior of the valve frame 1. The valve frame 1 is made of shape memory alloy materials such as nickel-titanium alloy, possessing self-expanding elastic properties. The valve frame 1 includes multiple overlapping units 3 and multiple sets of limiting structures. The multiple overlapping units 3 overlap sequentially end-to-end along the circumferential direction to form a ring structure. Each overlapping unit 3 includes a mesh portion 33, and overlapping portions 31 and 32 respectively connected to opposite sides of the mesh portion 33. Figure 15As shown, in each pair of adjacent overlapping units 3, the overlapping part 31 of one overlapping unit 3 and the overlapping part 32 of the other overlapping unit 3 overlap and cooperate in the radial direction of the annular structure to form an inner overlapping part 34 and an outer overlapping part 35 that overlap inside and outside.

[0034] Each set of overlapping inner layer overlap 34 and outer layer overlap 35 is limited by a set of limiting structures. The limiting structures are configured to prevent the overlapping inner layer overlap 34 and outer layer overlap 35 from separating from each other, and to allow the inner layer overlap 34 and outer layer overlap 35 to slide relative to each other along the circumference of the annular structure until they are self-locked at a certain relative position when the annular structure is subjected to an external force that expands radially from the inside to the outside, thereby expanding and locking the radial dimension of the annular structure.

[0035] The sealing ring 6 is used to suture the expandable sutureless valve to the patient's original valve annulus after the valve is implanted into the target position, so as to seal the gap between the outer peripheral surface of the implanted valve frame 1 and the original valve annulus and avoid paravalvular leakage after the expandable sutureless valve is implanted. The annular structure of the sealing ring 6 and the valve frame 1 is fixedly connected by means including but not limited to suture connection.

[0036] In this embodiment, the expandable sutureless valve has at least four forms: natural form, first form, second form, and third state. The first form is the state after the valve frame 1 is radially compressed; the second state is the stable working state after the valve frame 1 is radially expanded to the required radial size; and the third state is the state after secondary expansion. The process of the expandable sutureless valve from its natural form to its first form needs to be carried out at a certain temperature / temperature range (e.g., 0°C-8°C) below the phase transition temperature, during which the valve 2 is radially contracted to a certain size along with the valve frame 1. The process of the expandable sutureless valve from its first form to its second form can be carried out at a certain temperature (e.g., body temperature) after the expandable sutureless valve is implanted into the patient and the radial restraint on the valve frame 1 is released. The valve 2 then expands to its second form along with the valve frame 1. At this time, the sealing ring 6 is placed on the original valve annulus, and the lower part of the sealing ring 6 is compressed by the original valve annulus to form a stable working state slightly smaller than the size of the valve frame's natural form, providing a certain degree of radial support and sealing for the valve 2. The process from the second to the third stage occurs after the failure of the initially implanted expandable sutureless valve, during which a new valve is implanted into the expandable sutureless valve a second time. This is achieved by inserting a balloon into the valve frame 1 of the initially implanted expandable sutureless valve, using the balloon to expand the valve frame 1 a second time, ultimately expanding the annular structure of the valve frame 1 to a larger radial dimension, and locking the radial dimension of the annular structure through the aforementioned limiting structure. At this point, a new valve of a larger size is implanted into the expanded valve frame 1 a second time, effectively improving the problem of narrowing of the valve orifice area after the new valve is implanted, ensuring the improvement of postoperative symptoms and improving the long-term survival rate of patients.

[0037] During the surgery, a minimally invasive aortic valve replacement is performed under visual guidance, combined with cardiopulmonary bypass. First, the original aortic valve leaflets and calcified tissue are removed. Then, the expandable sutureless valve is radially compressed and inserted into the sheath of the delivery system outside the body. The expandable sutureless valve changes from its natural shape to its first radially compressed shape. Next, under direct vision, the tip of the delivery system sheath is placed at the aortic valve annulus, and the expandable sutureless valve is released. After release, the valve expands along with the valve frame from its first shape to its second shape, where the sealing ring adheres to the original valve annulus, and the valve can then begin to function normally. When the initially implanted valve reaches the end of its service life and requires a replacement valve, a balloon is used to expand the initially implanted valve again. The circumference and radial dimensions of the expandable sutureless valve will increase, and the valve will change from its second shape to its third shape along with the valve frame. This ensures that the newly implanted valve can have a larger circumference and radial dimensions, effectively improving the problem of narrowing of the valve orifice area after the second implantation and improving the treatment effect.

[0038] In summary, compared with the prior art, the expandable sutureless flap provided in this embodiment can achieve at least the following beneficial effects: (1) Compared with the treatment method of surgically suturing the valve in the prior art, the surgery using the expandable sutureless valve provided in this embodiment is less traumatic (belonging to the type of minimally invasive surgery), which can reduce patient damage. At the same time, since it does not require full valve annulus suturing, it can reduce operation time, reduce cardiopulmonary bypass time, and reduce the learning curve for doctors. (2) Compared with the treatment method using interventional valves in the prior art, the use of the expandable sutureless valve provided in this embodiment can remove the original calcified valve leaflets, improve the surgical effect, and the surgery is completed under visual observation, making the operation easier and avoiding radiation hazards. (3) Compared with the treatment method using traditional sutureless flaps in the prior art, the expandable sutureless flap provided in this embodiment can be used for surgery. When the expandable sutureless flap is radially compressed (the first state mentioned above), the size that can be radially compressed is smaller, which can increase the field of vision during the operation and make it easier for doctors to operate. (4) In the prior art, when the first implanted valve reaches the end of its service life, a new valve needs to be implanted into the patient. Regardless of whether the first implanted valve is a surgically sutured valve, an interventional valve, or a traditional sutureless valve, the radial dimension of the second implanted valve is usually slightly smaller than that of the first implanted valve; otherwise, it would be difficult to operate with the existing implantation methods. However, the smaller effective opening area of ​​the second implanted valve will affect the postoperative effect, not only affecting the improvement of symptoms but also leading to more serious hemodynamic disorders and reducing the patient's long-term survival rate. When the expandable sutureless valve provided in this embodiment is implanted for the first time, if the valve fails, its frame can be expanded outward with a balloon to increase the circumferential length and radial dimension of the valve. Then, a new valve is implanted into the frame. As a result, the new valve implanted in the second implantation has a larger circumference and radial dimension than the new valves that can be implanted with existing technology, so as to effectively improve the problem of narrowing of the valve orifice area of ​​the newly implanted valve, ensure the improvement of postoperative symptoms and improve the long-term survival rate of patients.

[0039] Reference Figures 7 to 15 In an optional embodiment of this example, in each set of overlapping inner layer overlap portions 34 and outer layer overlap portions 35: the limiting structure of the petiole frame 1 includes at least two limiting holes 41 provided in the outer layer overlap portion 35 and at least two elastic locking strips 42 provided on the outer peripheral surface of the inner layer overlap portion 34. One end of the elastic locking strip 42 is radially outward along the annular structure of the petiole frame 1 to form a locking end 421. All the limiting holes 41 are arranged at intervals along the circumferential direction of the annular structure of the petiole frame 1, and all the elastic locking strips 42 are arranged at intervals along the circumferential direction of the annular structure of the petiole frame 1. When the overlapping inner layer overlap portion 34 and outer layer overlap portion 35 are locked in a certain relative position, the locking end 421 of at least one elastic locking strip 42 is engaged with or passes through the corresponding limiting hole 41.

[0040] For example, such as Figure 9 and Figure 10 As shown, in the first locked state, the outer overlapping part 35 and the inner overlapping part 34 are locked in a relative position. At this time, it can correspond to the natural form of the petiole frame 1 or the second form of the petiole frame 1. However, the radial dimension of the petiole frame 1 has not yet reached the maximum size that can be expanded. When a balloon is inserted into the petiole frame 1 and the petiole is used to expand the petiole frame 1 radially, the radial dimension of the petiole frame 1 can continue to expand. like Figure 11 and Figure 12 As shown, in the second locked state, the radial dimension of the petal frame 1 is radially expanded to a larger radial dimension, and the overlapping outer layer 35 and the overlapping inner layer 34 are self-locked at another corresponding relative position. At this time, the third form of the petal frame 1 can be obtained.

[0041] With the above structure, the valve 1 can be positioned in at least two preset radial dimensions (e.g. Figure 9 , Figure 10 The first locking state shown and Figure 11 , Figure 12The second locking state shown is stable and self-locking; and multiple sets of "clasp ends 421 snapping into or passing through the corresponding limiting holes 41" are arranged circumferentially, which automatically complete the snapping into the hole action during balloon pressurization. The operation is simple and efficient, and the inner layer overlap 34 and the outer layer overlap 35 after locking are structurally stable and reliable under dynamic conditions such as blood flow impact and myocardial contraction. The elastic buckle strip 42 can be integrally formed with the overlapping part of the overlapping unit 3 by cutting and processing, or it can be connected to the overlapping part of the overlapping unit 3 by welding, riveting or other fixed connection methods.

[0042] Reference Figure 13 In this embodiment, the snap-on end 421 of the elastic snap-on strip 42 includes an extension section 4211. One end of the extension section 4211 is fixedly connected or integrally connected to the outer peripheral surface of the inner layer overlap portion 34. The radial distance between the extension section 4211 and the outer peripheral surface of the inner layer overlap portion 34 gradually increases from the end of the extension section 4211 connected to the inner layer overlap portion 34 to the other end of the extension section 4211. In this structure, the progressive radial distance design of the extension section 4211 plays a guiding role, making it easier for the snap-on end 421 to be aligned and inserted into the limiting hole 41, thus reducing the difficulty of operation.

[0043] Reference Figure 14 Optionally, the snap-fit ​​end 421, in addition to the aforementioned extension section one 4211, also includes extension section two 4212; one end of extension section two 4212 is integrally connected to the end of extension section one 4211 away from the inner layer overlap portion 34. In some more specific structures, extension section two 4212 is parallel to the outer peripheral surface of the inner layer overlap portion 34 (not shown), or, as... Figure 14 As shown, the radial distance between the outer peripheral surface of extension segment 4212 and the inner layer overlap portion 34 gradually decreases from the end where extension segment 4212 connects to extension segment 4211 to the other end of extension segment 4212 (extension segment 4212 forms a radially inwardly buckled elastic end structure). When the inner layer overlap portion 34 and the outer layer overlap portion 35 overlap internally and externally, the outer peripheral surfaces of extension segment 4212 and the outer layer overlap portion 35 are parallel to each other (not shown), or, as... Figure 14 As shown, the radial distance between the second extension section 4212 and the outer peripheral surface of the outer layer overlap 35 gradually decreases from the end where the second extension section 4212 is connected to the first extension section 4211 to the other end of the second extension section 4212 (the second extension section 4212 forms a radially inward elastic end structure).

[0044] In this structure, the combined design of extension section one 4211 and extension section two 4212 provides multi-level constraints, further enhancing the bonding force between the snap-on end 421 and the limiting hole 41, and further preventing the outer overlapping part 35 and the inner overlapping part 34 from loosening when facing pressures such as high blood flow impact and myocardial contraction, thereby improving the effective service life of the expandable sutureless flap in the patient's body.

[0045] When the snap-on end 421 includes extension section one 4211 and extension section two 4212, preferably, the extension section two 4212 and extension section one 4211 are connected by an arc transition to reduce the stress concentration points of the overall structure of the elastic snap-on strip 42, improve its overall strength and durability, and at the same time help the snap-on end 421 to pass smoothly through the limiting hole 41.

[0046] Reference Figure 7 , Figure 8 as well as Figures 15 to 18 In an optional embodiment of this example, in each set of overlapping inner layer overlap portion 34 and outer layer overlap portion 35: the limiting structure of the petal frame 1 further includes a guide hole 51 provided in the inner layer overlap portion 34, a guide hole 52 provided in the outer layer overlap portion 35, and a limiting fastener 53 assembled in the guide hole 51 and the guide hole 52; the guide hole 51 and the guide hole 52 both extend circumferentially along the annular structure of the petal frame 1; the limiting fastener 53 includes a central connecting rod 531 and limiting heads 532 connected to both ends of the central connecting rod 531. Along the radial direction of the annular structure of the petal frame 1: the central connecting rod 531 passes through the guide hole 1 51 and the guide hole 2 52, one limiting head 532 is limited to the inner side of the inner overlapping part 34, and the other limiting head 532 is limited to the outer side of the outer overlapping part 35. The central connecting rod 531 can slide in the guide hole 1 51 and the guide hole 2 52 along the circumference of the annular structure of the petal frame 1.

[0047] In this structure, by providing guide holes 51 and 52 on the outer overlapping portion 35 and inner overlapping portion 34 of two adjacent overlapping units 3, and assembling limiting fasteners 53, a dual constraint of circumferential reciprocating movement limitation and radial limitation is formed for the overlapping outer overlapping portion 35 and inner overlapping portion 34. This ensures the stable connection of the outer overlapping portion 35 and inner overlapping portion 34 of two adjacent overlapping units 3, preventing the outer overlapping portion 35 and inner overlapping portion 34 from loosening during use. At the same time, guide holes 51 and 52 extend circumferentially along the annular structure of the valve frame 1, providing a clear circumferential guiding path for the relative movement of the two adjacent overlapping units 3 when the valve frame 1 is expanded. This ensures that the shape of the expanded valve frame 1 can meet the surgical requirements without uncontrollable deformation problems that would affect the surgical outcome.

[0048] like Figure 15As shown, in each set of overlapping inner layer overlaps 34 and outer layer overlaps 35, along the radial direction of the annular structure of the petal frame 1: the limiting head 532 of the limiting fastener 53 located on the inner side of the inner layer overlap 34 has its side surface facing the inner layer overlap 34 in contact with the inner circumferential surface of the inner layer overlap 34; the limiting head 532 of the limiting fastener 53 located on the outer side of the outer layer overlap 35 has its side surface facing the outer layer overlap 35 in contact with the outer circumferential surface of the outer layer overlap 35.

[0049] The above structure can further limit unnecessary radial displacement of the outer layer overlap 35 and the inner layer overlap 34 when the diameter of the petal frame 1 is expanded, and further improve the stability of the annular structure of the expanded petal frame 1.

[0050] In an optional embodiment of this example, the two side walls of each of the guide holes 51 and 52 extending circumferentially along the annular structure of the petal frame 1 are planar side walls; the circumferential surface of the central connecting rod 531 has a first plane and a second plane arranged opposite to each other; the first plane slides in cooperation with the planar side wall of the guide holes 51 and 52 located on the same side; the second plane slides in cooperation with the planar side wall of the guide holes 51 and 52 located on the other side, so as to avoid relative rotation between two adjacent overlapping units 3.

[0051] The above structure can further improve the path certainty of the relative movement of two adjacent overlapping units 3 when expanding the diameter of the petal frame 1, so as to further improve the morphological consistency and structural stability of the expanded petal frame 1.

[0052] Reference Figures 1 to 6 In an optional embodiment of this invention, the sealing ring 6, which is a ring structure surrounding the valve frame 1 circumferentially on the proximal outer surface of the valve frame 1, is made of an elastomer. Optionally, the sealing ring 6 further includes a polymer fabric membrane (polyester fabric, etc.) wrapped around its elastomer body; and / or, optionally, a plurality of exposed suture loops 61 are provided circumferentially on the sealing ring 6 for point-suturing the sealing ring 6 to the aortic valve annulus after implantation.

[0053] Finally, it should be noted that the above embodiments and optional implementations in this specification are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing optional implementations, or equivalent substitutions can be made to some or all of the technical features therein. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention. Furthermore, it is emphasized again that, in the absence of conflict, the features of the embodiments and optional implementations in the embodiments in this specification can be combined with each other.

Claims

1. An expandable sutureless flap, characterized in that, It includes a valve frame (1), a valve (2) fixedly connected to the valve frame (1), and a sealing ring (6) sleeved and fixedly connected to the proximal outside of the valve frame (1). The petal frame (1) includes multiple overlapping units (3) and multiple sets of limiting structures; Multiple overlapping units (3) are sequentially overlapped end to end along the circumference to form a ring structure; each overlapping unit (3) includes a grid part (33) and overlapping part one (31) and overlapping part two (32) respectively connected to opposite sides of the grid part (33); in each pair of adjacent overlapping units (3), overlapping part one (31) of one overlapping unit (3) and overlapping part two (32) of the other overlapping unit (3) overlap and cooperate in the radial direction of the ring structure to form an inner overlapping part (34) and an outer overlapping part (35) that overlap inside and outside. Each set of overlapping inner layer overlaps (34) and outer layer overlaps (35) is limited by a set of limiting structures. The limiting structures are configured to prevent the overlapping inner layer overlaps (34) and outer layer overlaps (35) from separating from each other, and to allow the inner layer overlaps (34) and outer layer overlaps (35) to slide relative to each other along the circumference of the annular structure until they are self-locked at a certain relative position under the action of an external force that expands the annular structure from the inside to the outside in the radial direction, thereby expanding and locking the radial dimension of the annular structure.

2. The expandable sutureless flap according to claim 1, characterized in that, In each group of overlapping inner layer (34) and outer layer (35): The limiting structure includes at least two limiting holes (41) provided on the outer layer overlap (35) and at least two elastic buckle strips (42) provided on the outer peripheral surface of the inner layer overlap (34). One end of the elastic buckle strip (42) is raised outward along the radial direction of the annular structure to form a buckle end (421). All of the limiting holes (41) are arranged at intervals along the circumference of the annular structure, and all of the elastic buckle strips (42) are arranged at intervals along the circumference of the annular structure; When the inner overlapping portion (34) and the outer overlapping portion (35) are locked in a certain relative position, the snapping end (421) of at least one of the elastic snap strips (42) snaps into or passes through the corresponding limiting hole (41).

3. The expandable sutureless flap according to claim 2, characterized in that, The snap-fit ​​end (421) includes an extension section (4211); one end of the extension section (4211) is fixedly connected or integrally connected to the outer peripheral surface of the inner layer overlap (34), and the radial distance between the extension section (4211) and the outer peripheral surface of the inner layer overlap (34) gradually increases from the end of the extension section (4211) connected to the inner layer overlap (34) to the other end of the extension section (4211).

4. The expandable sutureless flap according to claim 3, characterized in that, The latch end (421) also includes an extension section two (4212); One end of the second extension segment (4212) is integrally connected to the end of the first extension segment (4211) away from the second overlapping part (32); The second extension segment (4212) is parallel to the outer peripheral surface of the inner layer overlap (34), or the radial distance between the second extension segment (4212) and the outer peripheral surface of the inner layer overlap (34) gradually decreases from the end where the second extension segment (4212) connects to the first extension segment (4211) to the other end of the second extension segment (4212).

5. The expandable sutureless flap according to claim 4, characterized in that, The second extension segment (4212) and the first extension segment (4211) are connected by an arc transition.

6. The expandable sutureless flap according to claim 2, characterized in that, In each group of overlapping inner layer (34) and outer layer (35): The limiting structure also includes a guide hole 1 (51) provided in the inner layer overlap (34), a guide hole 2 (52) provided in the outer layer overlap (35), and a limiting fastener (53) assembled in the guide hole 1 (51) and the guide hole 2 (52). Both the first guide hole (51) and the second guide hole (52) extend circumferentially along the annular structure. The limiting fastener (53) includes a central connecting rod (531) and limiting heads (532) connected to both ends of the central connecting rod (531); along the radial direction of the annular structure: the central connecting rod (531) passes through the first guide hole (51) and the second guide hole (52), one of the limiting heads (532) is limited to the inner side of the inner layer overlap (34), and the other limiting head (532) is limited to the outer side of the outer layer overlap (35), and the central connecting rod (531) can slide in the first guide hole (51) and the second guide hole (52) along the circumference of the annular structure.

7. The expandable sutureless flap according to claim 6, characterized in that, In each group of overlapping inner layer overlaps (34) and outer layer overlaps (35), along the radial direction of the annular structure: The limiting head (532) of the limiting fastener (53) located inside the inner layer overlap (34) has its side surface facing the inner layer overlap (34) in contact with the inner circumferential surface of the inner layer overlap (34); the limiting head (532) of the limiting fastener (53) located outside the outer layer overlap (35) has its side surface facing the outer layer overlap (35) in contact with the outer circumferential surface of the outer layer overlap (35).

8. The expandable sutureless flap according to claim 6, characterized in that, The two side walls of each of the guide hole one (51) and the guide hole two (52) extending circumferentially along the annular structure are planar side walls; The circumferential surface of the central connecting rod (531) has a first plane and a second plane arranged opposite to each other; the first plane is slidably engaged with the sidewall of the plane located on the same side of the first guide hole (51) and the second guide hole (52); the second plane is slidably engaged with the sidewall of the plane hole located on the other side of the first guide hole (51) and the second guide hole (52).

9. The expandable sutureless flap according to any one of claims 1-8, characterized in that, The main body of the sealing ring (6) is made of an elastomer; and / or, a plurality of exposed stitching coils (61) are provided circumferentially on the sealing ring (6).

10. The expandable sutureless flap according to any one of claims 1-8, characterized in that, The main body of the sealing ring (6) is wrapped with a polymer fabric membrane.

Images