A structure of a valve seat and a biological valve

Abstract

The application discloses a valve seat structure and a biological valve. The valve seat structure comprises a basic valve seat, wherein the basic valve seat is an annular structure with two free ends, and the basic valve seat can be expanded to have a larger diameter when the basic valve seat is subjected to an expanding force from inside to outside; a flexible limiting member is arranged between the two free ends of the basic valve seat, the flexible limiting member can be unfolded when the basic valve seat is expanded, and the continuous expansion of the basic valve seat can be limited when the flexible limiting member is completely unfolded; the flexible limiting member is in a whole tubular structure, and the two ends of the flexible limiting member are respectively fixedly arranged on the two free ends of the basic valve seat. In the application, the structure of the flexible limiting member is arranged, so that the flexible limiting member can form a whole structure with the basic valve seat to the maximum extent, the influence of the arrangement of the flexible limiting member on the integrity of the valve seat structure is reduced, and the influence of the flexible limiting member on the human body is reduced.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of biological valve, and particularly relates to a valve seat structure for a biological valve and a biological valve adopting the valve seat structure. BACKGROUND

[0002] Heart valve disease is a common disease among heart diseases. In surgical operation, the diseased valve or damaged valve can be replaced or repaired. In a traditional valve replacement operation, the damaged leaflet is usually cut off and the valve ring is shaped to accept a replacement artificial valve.

[0003] An artificial heart valve usually comprises a support structure arranged at a valve assembly, which is usually made of a rigid structure and can be made of various biocompatible materials such as metal, plastic, ceramic, etc. The service life of a biological valve is usually 10-20 years, and the valve performance will decrease after reaching the service life. At this time, the patient is usually old and the body function is difficult to accept surgical operation, and currently an interventional valve is usually implanted in the original implanted biological valve. However, due to the influence of the original biological valve leaflet and the interventional valve frame, the implanted interventional valve is at least one size smaller than the original biological valve, which will greatly reduce the overall blood flow passage area (valve opening area) of the implanted biological valve, so that the postoperative heart blood flow dynamic condition cannot meet the needs of the patient's body, resulting in poor postoperative effect. SUMMARY

[0004] The purpose of the present application is to provide a valve seat structure and a biological valve, which solves the problem of poor effect of the biological valve after implanting an interventional valve.

[0005] The present application is realized by the following technical solutions:

[0006] A valve seat structure comprises a basic valve seat, which is an annular structure having two free ends. When the basic valve seat is subjected to an expanding force from inside to outside, the basic valve seat can be expanded to have a larger diameter.

[0007] A flexible limiting member is arranged between the two free ends of the basic valve seat. When the basic valve seat is expanded, the flexible limiting member can be unfolded, and when the flexible limiting member is completely unfolded, the continuous expansion of the basic valve seat can be limited. The flexible limiting member is in a tubular structure as a whole, and its two ends are respectively fixedly covered or sleeved on the two free ends of the basic valve seat, so that the flexible limiting member can cover or sleeve the area between the two free ends of the basic valve seat as a whole. In the unfolded state, the incomplete unfolded state and the unfolding process of the flexible limiting member, a part of the flexible limiting member is arranged in a tubular folded state outside one of its fixed ends, and the folded part always covers or sleeves outside the basic valve seat.

[0008] As a further improvement of the above technical solution, the flexible limiting member is provided with a notch along its axial direction from one end to the other end, so that when the flexible limiting member covers or sets the base valve seat, the outer edge of one side of the base valve seat set in the flexible limiting member can be exposed outside the flexible limiting member, and at this time the flexible limiting member covers both sides of the base valve seat symmetrically or asymmetrically.

[0009] As a further improvement of the above technical solution, the notch extends through the other end of the flexible limiting member, so that the end of the fixed end of the flexible limiting member covers both sides of the base valve seat, and the folded part of the flexible limiting member is located outside the fixed end of the flexible limiting member.

[0010] As a further improvement of the above technical solution, the two ends of the flexible limiting member are respectively fixed and connected on the base valve seat by binding lines; preferably, the base valve seat is provided with a notch at the position where the flexible limiting member is fixed.

[0011] As a further improvement of the above technical solution, the flexible limiting member does not break under the expansion force of 5-10 atmospheres.

[0012] As a further improvement of the above technical solution, the base valve seat is provided with a notch at the position where the flexible limiting member is fixed.

[0013] As a further improvement of the above technical solution, the base valve seat is provided with a fixed member between the two free ends for fixing and connecting the two free ends, the fixed member limits the free movement of the two free ends, so that the base valve seat can form a complete annular structure in the initial state, and when the base valve seat is subjected to an expansion force of a certain size, the fixed member breaks and fails to release the restraint of the two free ends; preferably, the fixed member does not break under the expansion force of 0-2 atmospheres, and breaks and fails under the expansion force of 2-5 atmospheres.

[0014] As a further improvement of the above technical solution, the fixed member is a valve capsule fixedly covering the abutting or overlapping surface of the two free ends of the base valve seat.

[0015] As a further improvement of the above technical solution, the valve capsule is obtained by dissolving or melting the valve capsule material and coating it between the abutting parts of the two free ends of the base valve seat or on the overlapping surface of the two free ends, and then solidifying and forming.

[0016] As a further improvement of the above technical solution, the valve capsule is made of a plastic material with elasticity, preferably silicone or polyurethane; preferably, the valve capsule is made of a plastic material with elasticity, preferably silicone or polyurethane.

[0017] As a further improvement of the above technical solution, the base valve seat is a double-layer structure formed by rolling a metal plate or strip in a ring direction, and the two layers of metal plates or strips are fixedly connected, and one or two layers of metal plates or strips are cut along the axial direction to form two free ends arranged in a matching lap joint on the base valve seat.

[0018] In another aspect, the application also provides a biological valve using the valve seat structure.

[0019] Compared with the prior art, the application has the following beneficial effects:

[0020] The valve seat structure in the application adopts a non-closed structure form, which can be expanded to the required specification diameter under external force, to solve the limitation of the specification size of the interventional valve when the interventional valve is implanted, and the flexible limiting member is arranged at the free end of the valve seat structure to limit the unlimited expansion of the valve seat structure under the expansion force, thereby ensuring the safety of the valve seat structure during use. By setting the structure of the flexible limiting member, the flexible limiting member can form an integral structure with the base valve seat to the greatest extent, thereby reducing the impact of the flexible limiting member on the integrity of the valve seat structure, and the flexible limiting member can always maintain good adhesion with the base valve seat in the unfolded state, the partially unfolded state, or the unfolding process, thereby further reducing the impact of the introduction and use of the flexible limiting member on the human body.

[0021] The valve seat capsule structure is arranged at the two free ends of the base valve seat in the valve seat structure, so that a closed structure is formed between the two non-closed free ends, thereby ensuring the stability and integrity of the valve seat structure before expansion, and further improving the practical performance of the valve seat structure. At the same time, the lap joint structure formed between the valve seat capsule and the double-layer metal structure of the base valve seat can form good cooperation, so that the valve seat structure has good elastic performance and better integrity. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the application, the drawings in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the application, and therefore should not be considered as limiting the scope. For those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0023] Figure 1 FIG. 1 is a structural schematic diagram of an embodiment of the valve seat structure of the application.

[0024] Figure 2 FIG. 2 is a partial schematic view of the valve seat structure of the application. Figure 1

[0025] Figure 3 ​A structural schematic diagram of one embodiment of the base valve seat in the valve seat structure of the present application.

[0026] Figure 4 A structural schematic diagram of one embodiment of the base valve seat in the valve seat structure of the present application. Figure 3 A local structural schematic diagram at B.

[0027] Figure 5 A structural schematic diagram of one embodiment of the base valve seat in the valve seat structure of the present application.

[0028] Figure 6 A structural schematic diagram of the connection between the flexible limiting member and the base valve seat in the valve seat structure of the present application.

[0029] Figure 7 A structural schematic diagram of the valve seat capsule in the valve seat structure of the present application.

[0030] Wherein: 10, base valve seat, 101, free end, 102, notch;

[0031] 20, flexible limiting member, 201, fixed end, 202, notch, 203, folded part;

[0032] 30, valve seat capsule. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical scheme and advantages of the embodiments of the present application more clear, the technical scheme of the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all the embodiments.

[0034] The valve seat structure is a component of a biological valve. When meeting the conventional functional properties and performance requirements of the biological valve, based on the conventional biological valve, when an interventional valve needs to be implanted, the interventional valve model to be implanted is one smaller than the biological valve previously implanted due to the deformation of the valve seat structure, thereby reducing the blood flow passage area after the interventional valve is implanted. In view of this problem, the valve seat structure is set as an expandable structure, so that when the interventional valve is implanted, the balloon can be used to expand the valve seat structure in the original biological valve, increase the inner diameter size of the valve seat structure, and at this time, the size of the interventional valve to be implanted again can be increased.

[0035] However, in the actual operation process, the force of the balloon when expanding the surgical valve seat is often large. When the valve seat structure is expanded and expanded, if the size of the valve seat structure cannot be effectively limited, it may cause serious damage to the original human body valve ring, and even cause life danger. Therefore, when the valve seat structure is designed as an expandable structure, how to limit the size of the valve seat expansion diameter and avoid unlimited expansion is a problem that needs to be solved.

[0036] Meanwhile, it is also necessary to consider that the stent structure, as a component of the biological valve, does not need to be expanded in the initial use stage after being implanted into the human body, and in this stage the stent structure needs to provide stable support for the biological valve as a stable structural member, and needs to maintain a stable shape and be able to withstand the normal diastolic pressure during the operation of the human heart without deformation, so high requirements are also put forward for the stability of the structure of the stent structure before expansion. How to balance the contradiction between the stability and expandability of the stent structure is also a problem to be considered.

[0037] In addition, as a device implanted into the human body, the structure also has some requirements different from the conventional requirements, such as the use of what kind of structure in the stent structure to limit the stent structure during expansion, and the introduction and use of the limiting structure during expansion to reduce the additional impact on the human tissue, which needs to consider the cooperation or fit between the limiting structure and the stent structure in the initial state and during expansion, which is also very important in the design of the stent structure.

[0038] Based on the above problems and actual needs, with reference to Figures 1 to 4 The stent structure in the embodiment includes a basic stent 10, which is a ring structure with two free ends 101. Of course, the ring structure here is only defined from the perspective of the overall structure form that can form a closed loop structure, and in the specific structure, it can be a circular ring or other conventional structures of existing stents in the circumferential direction, with reference to Figure 3 and 5 When the basic stent is subjected to an expanding force from the inside to the outside, such as the force provided by balloon expansion, the basic stent can be expanded to have a larger diameter.

[0039] As a limitation of the expansion size of the basic stent, a flexible limiting member 20 is arranged between the two free ends of the basic stent 10, which is an expandable structure when the basic stent expands, and can resist the expanding force brought by the balloon to limit the continuous expansion of the basic stent when the flexible limiting member is fully expanded. Here, in order to improve the overallity and fit between the flexible limiting member and the basic stent in any state as mentioned above, the structure of the flexible limiting member is designed. Specifically, with reference to Figure 1 , 26. The flexible restraint 20 is designed as a cylindrical structure, which can be a closed cylinder or a partially open cylindrical structure. Both ends of the flexible restraint 20 are fixedly covered or fitted onto the two free ends 101 of the base valve seat, forming a close fit between the flexible restraint and the base valve seat at the two fixed ends 201. At this time, the flexible restraint can completely cover or fit the area between the two free ends of the base valve seat, forming a good covering and fit with the base valve seat. Simultaneously, as a deformable structure, the flexible restraint 20 deforms along with the base valve seat during its expansion. To control the degree of fit between it and the base valve seat during deformation, a portion of the flexible restraint is kept in a cylindrical folded structure outside one of its fixed ends in the unexpanded, partially expanded, and unfolded states. This folded portion 203 always covers or fits the outside of the base valve seat. It is clear from existing technology and common sense that the structure of this folded portion 203 represents a state of a flexible material when it is not fully expanded. The outer side of the fixed end 201 mentioned here is relative to the other fixed end of the flexible restraint and the base flap seat. The outer side of the fixed end refers to the direction away from the other fixed end. This arrangement facilitates the storage of the flexible restraint in the initial state, so as to minimize the impact on the specifications and size of the base flap seat, and facilitates the flexible restraint to unfold better, the stability of the unfolding process, and the unfolded shape. Of course, the possibility of setting this folding structure in other directions is not excluded, such as setting it in the direction of the other fixed end. These are all easily conceived based on the structure of this embodiment.

[0040] As a preferred implementation method, such as Figure 2 As shown, a notch 202 is provided on the flexible restraint 20 along its axial direction from one end to the other. When the flexible restraint covers or is fitted onto the base valve seat, one outer edge of the base valve seat 10 fitted inside the flexible restraint can be exposed outside the flexible restraint. In this case, the flexible restraint 20 is symmetrically or asymmetrically fitted onto both sides of that portion of the base valve seat relative to the base valve seat 10. The purpose of this structure is to facilitate the installation of the flexible restraint on the base valve seat and to ensure that the flexible restraint maintains a good folding shape after installation.

[0041] In a preferred embodiment, the notch 202 extends through and passes through the other end of the flexible restrictor 20, so that the fixed end of the flexible restrictor 20 is covered and disposed on both sides of the base flap seat 10. At this time, the folded part of the flexible restrictor is located outside the fixed end of the flexible restrictor, so as to further facilitate the installation and setting of the flexible restrictor.

[0042] In particular, the flexible restriction member 20 as a foldable component, the material used should be foldable flexible material, such as fabric, silk, film and other materials with low elasticity or elasticity, which can be made on the basis of the prior art.

[0043] The two ends of the flexible restriction member 20 are fixedly connected to the two free ends 101 of the base valve seat by binding lines. The base valve seat 10 is provided with a notch 102 at the position where the flexible restriction member is fixed. When the flexible restriction member is fixed, it is tied and fixed at the notch position to reliably connect the flexible restriction member and the base valve seat. Of course, other structures such as fixing holes can be provided on the base valve seat as auxiliary structures for fixing the flexible restriction member.

[0044] The arc distance between the two fixed ends of the flexible restriction member 20 is the increased circumference of the preset expanded base valve seat. The flexible restriction member itself and the connecting force between the flexible restriction member and the base valve seat should be able to withstand the expansion pressure of 5-10 atm of the balloon 5 without being damaged.

[0045] As a preferred embodiment, in order to make the non-closed valve seat structure stable before expansion, with reference to Figure 7 In this embodiment, a rigid member for fixedly connecting the pair of two free ends 101 is provided between the two free ends 101 of the base valve seat 10. The rigid member is used to restrict the free movement of the two free ends, so that the base valve seat can form a complete annular structure in the initial state, and has the characteristic that when the base valve seat is subjected to a set size of expansion force, the rigid member can be damaged and failed to release the restraint of the two free ends. It is contemplated that the rigid member here is a structural member with the above functions, which can be connected to the two free ends by existing conventional structures such as binding, bonding, etc. Generally, the rigid member should be able to withstand the expansion pressure of 0-2 atm without being damaged, so that the base valve seat can maintain good integrity and stability before expansion; when subjected to an expansion force of 2-5 atm, it should be able to fail to achieve its role in the base valve seat of this structure.

[0046] As a specific implementable structure, the rigid member here can be a valve capsule 30 fixedly covered on the abutting or overlapping surface of the two free ends 101 of the base valve seat 10, with reference to Figure 7The petal seat bag 30 can be formed by dissolving or melting the raw material used for the petal seat bag, and then coating the surface between the abutting portions of the two free ends of the base petal seat or the surface of the overlapping portions of the two free ends. After the petal seat bag is solidified and shaped, the petal seat bag is formed. At this time, the petal seat bag is in a sleeve shape and is sleeved between the two free ends of the petal seat bag to form a fixed connection with the two free ends. When the base petal seat is subjected to an expansion force, the petal seat bag is damaged under the action of a shearing force, and the fixation and restriction of the two free ends are released. The petal seat bag 30 can be made of a plastic material with elasticity, such as silicone or polyurethane. The thickness of the petal seat bag is controlled within the range of 0.02-0.18 mm. Here, the petal seat bag is made of an elastic material, which can stably connect the base petal seat while having good fatigue resistance under the action of a continuous diastolic force, thereby improving the performance and service life of the petal seat bag.

[0047] As a preferred embodiment, refer to Figure 3 、 4 and 5, the base petal seat 10 is a double-layer structure formed by rolling a metal plate or a metal strip in a ring direction. The two layers of metal plates or metal strips are fixedly connected by welding to form an overall ring structure to increase the elasticity of the base petal seat. One layer of metal plate or strip is cut, or the two layers of metal plate or strip are cut at intervals to form two free ends 101 arranged in a matching overlapping manner on the base petal seat, so that the double-layer structure formed by rolling can form a good match on the overall structure while forming an overlapping structure. As shown in Figure 2 and 3 , the base petal seat structure is a double-layer structure formed by rolling a metal sheet. The two ends of the metal sheet are located on the inner side and the outer side of the ring structure and are arranged oppositely. At this time, the inner layer of metal plate is cut at a position away from the end of the metal sheet by a certain distance, so that a non-closed loop base petal seat is obtained, and the two free ends of the base petal seat form an overlapping matching structure of the inner and outer single-layer metal plates.

[0048] This embodiment is a biological valve which adopts the petal seat structure in the above-mentioned embodiments and has the functions of the corresponding petal seat structure.

[0049] That is, as a more preferred embodiment, the biological valve can adopt a multi-layer petal seat structure in a circumferential spiral shape, which includes a base petal seat, a flexible restriction member, and a petal seat bag. The biological valve adopting this petal seat structure can realize the A and B working states.

[0050] In the A working state, it is the initial use state of the biological valve, in which the valve seat capsule is fixedly connected to the two free ends of the base valve seat, meets the size and use requirements of the biological valve in the initial use state, and can withstand the normal diastolic force of the heart valve ring, and the base valve seat can always maintain good integrity and stability; at this time, the flexible limiting member is folded and rolled up and arranged on the base valve seat in this working state.

[0051] In the B working state, it is the expansion use state of the valve seat structure in the biological valve, in which an interventional valve is re-implanted in the biological valve, at this time the biological valve can be expanded by a balloon, the valve seat capsule is torn and damaged under the expansion force of the balloon, the restraint of the free end of the base valve seat is released, the two free ends of the base valve seat are relatively separated, the flexible limiting member is gradually pulled open in this process, the diameter of the base valve seat is increased, until the flexible limiting member is tensioned, and the diameter of the base valve seat is limited again through the flexible limiting member to meet the size requirements of the implanted interventional valve; after the interventional valve is implanted, the interventional valve supports the expanded base valve seat, so that the flexible limiting member is always in the open and tight state. Generally, according to the size requirements of the implanted interventional valve, the diameter of the base valve seat in the B working state is 1-4mm larger than that in the A working state.

[0052] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship of the product in use, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element must have a particular orientation, be constructed and operated in a particular orientation, therefore it cannot be understood as a limitation of the present application.

[0053] In addition, the terms "horizontal", "vertical" and the like in the description of the present application do not mean that the components must be absolutely horizontal or vertical, but can be slightly inclined. For example, "horizontal" only means that its direction is more horizontal relative to "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0054] In the description of the present application, it also needs to be explained that, unless explicitly specified and limited, if the terms "set", "install", "connect", "connect" appear, they should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0055] The above is only the preferred embodiment of the present application, not any form of limitation on the present application, any simple modification, equivalent change of the above embodiment according to the technical essence of the present application falls within the protection scope of the present application.

Claims

1. A valve seat structure, characterized in that, Includes a base valve seat, which is an annular structure with two free ends. When the base valve seat is subjected to an expansion force from the inside out, the base valve seat can expand to have a larger diameter. A flexible limiting member is provided between the two free ends of the basic valve seat. The flexible limiting member can be unfolded when the basic valve seat expands, and can limit the continued expansion of the basic valve seat when the flexible limiting member is fully unfolded. The flexible limiting member is cylindrical in shape, and is a closed cylinder or a partially open cylindrical structure. Its two ends are respectively fixedly covered or sleeved on the two free ends of the basic valve seat, so that the flexible limiting member can completely cover or sleeve the area between the two free ends of the basic valve seat. In the unfurled state, the partially unfolded state and during the unfolding process, a part of the flexible limiting member is folded in a cylindrical shape on the outside of one of its fixed ends. The outside of the fixed end refers to the side facing away from the other fixed end, and this folded part always covers or sleeves the outside of the basic valve seat. A fixing member is provided on the base petal seat between its two free ends for fixing the two free ends. The fixing member is used to restrict the free movement of the two free ends, so that the base petal seat can form a complete ring structure in the initial state. When the base petal seat is subjected to an expansion force of a set size, the fixing member will fail and release the restraint on the two free ends.

2. The valve seat structure according to claim 1, characterized in that, The flexible limiting member has a notch along its axial direction from one end to the other, so that when the flexible limiting member covers or is sleeved on the base valve seat, one outer edge of the base valve seat sleeved inside the flexible limiting member can be exposed outside the flexible limiting member. At this time, the flexible limiting member covers and is symmetrically or asymmetrically covering both sides of this part of the base valve seat.

3. The valve seat structure according to claim 2, characterized in that, The notch extends through the other end of the flexible restraint, so that the fixed end of the flexible restraint covers both sides of the base flap seat, and the folded portion of the flexible restraint is located outside the fixed end of the flexible restraint.

4. The valve seat structure according to claim 1, characterized in that, The two ends of the flexible restraint are respectively fixedly connected to the base valve seat by binding wires.

5. The valve seat structure according to claim 4, characterized in that, The base valve seat has a slot at the position of the fixed flexible restraint.

6. The petal seat structure according to any one of claims 1-4, characterized in that, The flexible restraint does not break under the expansion force of 5-10 atmospheres.

7. The valve seat structure according to claim 1, characterized in that, The fixed component does not break under an expansion force of 0-2 atmospheres, but fails under an expansion force of 2-5 atmospheres.

8. The valve seat structure according to claim 1, characterized in that, The fixing component is a valve seat capsule that is fixedly covered and installed on the surface of the docking or overlapping part at the two free ends of the base valve seat.

9. The valve seat structure according to claim 8, characterized in that, The valve capsule is obtained by dissolving or melting the valve capsule material, coating it between the joints of the two free ends of the base valve capsule or on the surface of the overlapping part of the two free ends, and then curing it.

10. The valve seat structure according to claim 9, characterized in that, The valve capsule is made of elastic plastic material.

11. The valve seat structure according to claim 10, characterized in that, The valve capsule is made of silicone and polyurethane materials.

12. The valve seat structure according to claim 1, characterized in that, The base petal seat is a double-layer structure made of metal plates or strips rolled in a circular direction. The two layers of metal plates or strips are fixedly connected. One or two layers of metal plates or strips are cut along their axial direction to form two free ends that are fitted and overlapped on the base petal seat.

13. A biological valve employing the valve seat structure described in any one of claims 1-12.

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