Prosthetic heart valve and supporting structure thereof

Abstract

The utility model provides an artificial heart valve and a supporting structure thereof. The supporting structure is provided with a first end and a second end which are oppositely arranged in the axial direction of the supporting structure, and the supporting structure comprises an artificial valve ring arranged at the first end and a grid support connected with the artificial valve ring in the axial direction. The artificial valve ring and the grid support are coaxially arranged; the supporting structure further comprises a notch, and the notch comprises a first notch and a second notch. The artificial valve ring is of an open annular structure, and a first notch is formed between the two circumferential ends of the open annular structure. A second notch is formed in the position, corresponding to the first notch, of the grid support. According to the utility model, post-operation conduction block and coronary artery blockage can be avoided, and the difficulty in developing and positioning in an operation is reduced.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical equipment, and particularly relates to an artificial heart valve and a supporting structure thereof. Background Art

[0002] The heart contains four chambers, of which the left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart. The ventricular inflow tract is formed between the atrium and the ventricle, the left ventricular outflow tract is formed between the left ventricle and the aorta, and the right ventricle and the pulmonary artery form the right ventricular outflow tract. There are valves with "one-way valve" functions at the ventricular inflow tract and ventricular outflow tract to ensure the normal flow of blood in the heart chamber; when there is a problem with the valve, the heart's hemodynamics changes and the heart function is abnormal, which is called valvular heart disease.

[0003] At present, traditional surgical treatment is still the first choice for patients with severe valvular disease. However, for patients of advanced age, combined with multiple organ diseases, with a history of open-chest surgery, and with poor heart function, traditional surgical treatment is risky, and some patients do not even have the opportunity for surgery. Transcatheter valve replacement and repair has the advantages of no need for open-chest surgery, less trauma, and faster patient recovery, and has attracted widespread attention from experts and scholars. Different heart valve structures require different anatomical structures and pathological requirements for valve prostheses during interventional treatment. The valves at the left ventricular inflow tract and the right ventricular inflow tract are the mitral valve and the tricuspid valve, respectively. Both valves are combined, including the valve ring, leaflets, chordae tendineae and papillary muscles, and sometimes also include the ventricular wall. The chordae tendineae are the supporting devices connecting the mitral valve leaflets to the myocardium, and are distributed between the leaflets and the ventricular wall. Since the subvalvular structure of the mitral valve plays an important role in maintaining the structure and function of the left ventricle, the native valve structure is preserved as much as possible during surgery. Therefore, the design of the valve prosthesis is required to be high. The tricuspid valve is the atrioventricular valve of the right atrium, and its structure is similar to that of the mitral valve. Implants used to treat native mitral valves can usually also be used for native tricuspid valves. In recent years, the field of heart valves has developed rapidly, but there are still some problems that need to be solved, including:

[0004] First, when implanting the aortic valve, the implantation position of the artificial heart valve is close to the coronary artery orifice, which is easy to block the coronary artery orifice. If the mitral valve and tricuspid valve are implanted, especially the tricuspid valve, the implantation position of the artificial heart valve is close to the atrioventricular node, which increases the risk of conduction block after surgery.

[0005] Second, after implantation of the mitral or tricuspid valve, the artificial heart valve is prone to paravalvular leakage;

[0006] Third, it is difficult to visualize and locate the artificial heart valve during surgery, which increases the difficulty of the surgical operation.

[0007] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art. Utility Model Content

[0008] The utility model aims to provide an artificial heart valve and a supporting structure thereof, which can avoid postoperative conduction block and coronary artery occlusion and reduce the difficulty of intraoperative imaging positioning.

[0009] To achieve the above-mentioned purpose, the utility model provides a support structure for an artificial heart valve, the support structure having a first end and a second end arranged opposite to each other along its own axial direction, the support structure comprising an artificial valve ring arranged at the first end and a grid support axially connected to the artificial valve ring; the artificial valve ring is arranged coaxially with the grid support; the support structure also includes a notch, the notch comprising a first notch and a second notch; the artificial valve ring is an open annular structure to form the first notch between the circumferential ends of the open annular structure; the second notch is provided at a position on the grid support corresponding to the first notch.

[0010] In some embodiments, the shape of the outer peripheral surface of the support structure matches the shape of the native valve annulus and can change as the morphology of the native valve annulus changes.

[0011] In some embodiments, the support structure is configured such that the outer circumferential surface of the support structure is circular when the ventricle is in diastole, and is further configured such that the outer circumferential surface of the support structure is D-shaped when the ventricle is in contraction.

[0012] In some embodiments, the support structure also has at least one of the following features;

[0013] The width of the second notch along the circumferential direction decreases from the first end to the second end;

[0014] The maximum width of the second notch extending in the circumferential direction is the same as or different from the width of the first notch extending in the circumferential direction;

[0015] The maximum width of the second notch is N times the width of the grid in the grid bracket, where N is a positive integer greater than 1;

[0016] The height of the notch extending in the axial direction is M times the height of the grid in the grid support, where M is a positive integer greater than or equal to 1.

[0017] In some embodiments, the maximum width of the second gap is 2 times, 4 times, or 6 times the width of the grid in the grid support.

[0018] In some embodiments, the second notch is V-shaped or rectangular.

[0019] In some embodiments, the center angle of the first notch is 15°-120°.

[0020] In some embodiments, the center angle of the first notch is 30°-90°.

[0021] In addition, based on the same inventive concept, the utility model also provides an artificial heart valve, which is provided with any one of the supporting structures of the artificial heart valve described.

[0022] In some embodiments, the notch is axially aligned with a connection point of two adjacent artificial leaflets in the artificial heart valve, and / or the artificial heart valve further includes a skirt having a break corresponding to the notch.

[0023] Compared with the prior art, the artificial heart valve and its supporting structure of the utility model have at least the following advantages:

[0024] The support structure of the above artificial heart valve includes: an artificial valve ring arranged at the first end and a grid support axially connected to the artificial valve ring; the artificial valve ring is arranged coaxially with the grid support; the support structure also includes a notch, and the notch includes a first notch and a second notch; the artificial valve ring is an open annular structure to form the first notch between the two circumferential ends of the open annular structure; the second notch is provided at a position corresponding to the first notch on the grid support. With such a configuration, the above support structure can form an incompletely closed structure through the notch, which can not only reduce the risk of postoperative conduction block and coronary artery obstruction, but also be suitable for patients with more complex mitral and tricuspid non-circular valve rings, and can also increase the structural recognition during intraoperative image development and positioning, thereby facilitating intraoperative development and positioning of the valve and reducing the difficulty of surgical operation.

[0025] Since the artificial heart valve provided in the present application and the supporting structure of the artificial heart valve provided in the present application belong to the same inventive concept, the artificial heart valve provided in the present application at least has all the beneficial effects of the supporting structure of the artificial heart valve provided in the present application. Therefore, the beneficial effects of the artificial heart valve provided in the present application will not be described one by one here. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation on the present invention.

[0027] Figure 1 It is a schematic diagram of the structure of an artificial heart valve provided by the utility model according to one embodiment;

[0028] Figure 2 It is a schematic structural diagram of an artificial valve ring of an artificial heart valve provided by the utility model according to one embodiment;

[0029] Figure 3 It is a structural schematic diagram of a support structure of an artificial heart valve provided by the utility model according to an embodiment;

[0030] Figure 4 This is a schematic diagram of an application scenario of an artificial heart valve provided by the utility model according to an embodiment of the present invention being implanted into an aortic valve;

[0031] Figure 5 This is a schematic diagram of an application scenario of an artificial heart valve implanted into a tricuspid valve according to an embodiment of the present invention;

[0032] Figure 6 It is a schematic structural diagram of an artificial heart valve provided by the utility model according to an embodiment, which is initially circular and adapted to the native valve ring;

[0033] Figure 7 It is a structural schematic diagram of an artificial heart valve provided by the utility model according to an embodiment, which is D-shaped and adapted to the native valve ring when the ventricle contracts;

[0034] Figure 8 It is a schematic diagram of a local structure in which the gap width is twice the grid width provided by the utility model according to an embodiment;

[0035] Fig. 9 It is a schematic diagram of a local structure in which the gap width is 4 times the grid width provided by the utility model according to an embodiment;

[0036] Fig.10 It is a schematic diagram of a local structure in which the gap width is 6 times the grid width provided by the utility model according to an embodiment;

[0037] Fig.11 is an intraoperative development image of an artificial heart valve provided in a comparative embodiment;

[0038] Fig.12 This is a development image during artificial heart valve surgery provided by the utility model according to one embodiment.

[0039] [Description of reference numerals is as follows]:

[0040] 100-artificial heart valve; 110-support structure; 111-artificial valve ring; 112-grid support; 113-first notch; 114-second notch; 1101-first end; 1102-second end; 120-artificial valve leaflet; 130-skirt; 131-inner skirt; 132-outer skirt; W1-grid width; W2-maximum width of the second notch; A-notch; B-lowest point. DETAILED DESCRIPTION

[0041] The following describes the implementation of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific implementations, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner, so the diagram only shows the components related to the present invention rather than drawing according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0042] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise of being possible to implement, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0043] As used in this specification, the singular forms "one", "an", and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between two elements or an interactive relationship between two elements. Relational terms such as the terms "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly indicate the number of technical features indicated. It should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0044] The utility model aims to provide an artificial heart valve and a supporting structure thereof, aiming to solve the problems of postoperative conduction block and coronary artery obstruction and reduce the difficulty of intraoperative imaging positioning.

[0045] In one application scenario, the artificial heart valve provided by the utility model does not block the opening of the coronary artery after being implanted in the aortic valve, and facilitates intraoperative imaging and positioning, thereby reducing the difficulty of surgical operation.

[0046] In other application scenarios, the artificial heart valve provided by the utility model does not block the atrioventricular node after being implanted in the mitral valve or tricuspid valve, and basically no conduction block will occur. It can also effectively eliminate reflux and reduce the risk of paravalvular leakage. At the same time, it is convenient for intraoperative imaging and positioning, reducing the difficulty of surgical operation.

[0047] In order to make the purpose, advantages and features of the utility model clearer, the utility model is further described in detail in conjunction with the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the utility model. The same or similar figure marks in the drawings represent the same or similar parts. The "axial" mentioned herein generally refers to the central axis direction of the artificial heart valve, and the "circumferential" refers to the direction surrounding the central axis of the artificial heart valve.

[0048] Please refer to Figures 1 to 3 The utility model provides an artificial heart valve 100, including a support structure 110, an artificial valve leaflet 120 and a skirt 130. The support structure 110 can provide several functions for the artificial heart valve 100, including serving as the main structure of the valve, carrying the internal artificial valve leaflet 120, etc. The support structure 110 is a hollow cylindrical structure, in which the artificial valve leaflet 120 is arranged in the inner cavity, and the artificial valve leaflet 120 is sutured and fixed to the support structure 110 and the skirt 130.

[0049] The artificial valve leaflets 120 can dynamically switch between open and closed states; in the closed state, each artificial valve leaflet 120 is closed or converged in a sealed abutment manner, acting as a "one-way valve"; in the open state, each artificial valve leaflet 120 opens away from each other to allow blood to flow through. The artificial valve leaflet 120 can be formed of any suitable material or a combination of multiple materials. The material of the artificial valve leaflet 120 can be selected from biological tissue, such as chemically stable tissue from the heart valve of an animal (such as a pig), or pericardial tissue of an animal, such as cow (bovine pericardium) or sheep (sheep pericardium) or pig (porcine pericardium) or horse (equine pericardium), preferably bovine pericardial tissue. Optionally, the artificial valve leaflet 120 has a surface treated with (or reacted with) an anticoagulant, and the anticoagulant includes but is not limited to heparinized polymers.

[0050] The skirt 130 may include at least one of an inner skirt 131 and an outer skirt 132. Preferably, the inner skirt 131 and the outer skirt 132 exist at the same time for better sealing. The skirt 130 is sutured and fixed to the support structure 110 and the artificial valve leaflet 120. It can be understood that the inner skirt 131 is arranged in the inner cavity of the support structure 110, and covers part of the inner surface or the entire inner surface of the support structure 110. The outer skirt 132 is arranged on the outside of the support structure 110, mainly covering part of the outer surface of the support structure 110. The outer skirt 132 is usually only arranged at the inflow end of the support structure 110 and covers the outer surface at the inflow end, while the inner skirt 131 at least covers the inner surface at the inflow end, and further can cover the entire inner surface of the support structure 110 (see Figure 1 ).

[0051] Specifically, the support structure 110 has a first end 1101 and a second end 1102 that are disposed opposite to each other along its axial direction; one of the first end 1101 and the second end 1102 is an inflow end, and the other is an outflow end. Figure 1 As described, for implantation of the mitral valve and the tricuspid valve, the first end 1101 is the inflow end, and the second end 1102 is the outflow end. For implantation of the aortic valve, the first end 1101 is the outflow end, and the second end 1102 is the inflow end. In addition, the support structure 110 includes an artificial valve ring 111 disposed at the first end 1101 and a mesh support 112 axially connected to the artificial valve ring 111, and the artificial valve ring 111 and the mesh support 112 are arranged coaxially. The provision of the artificial valve ring 111 can enhance the strength of the mesh support 112 and increase the stability of the structure.

[0052] The artificial valve ring 111 mainly adopts rigid and elastic materials, including various biocompatible polymers and metals or alloys. The artificial valve ring 111 is more suitable for shape memory elastic material, and nickel-titanium alloy is more commonly used, but it is not limited to this. The mesh stent 112 adopts the same or different material as the artificial valve ring 111. The mesh stent 112 can be made of nickel-titanium alloy or biocompatible metal. The mesh stent 112 can be laser engraved from a metal tube, or woven from silk threads. The mesh stent 112 is more suitable for a cutting stent. The mesh stent 112 can be made into various shapes and sizes, without limitation.

[0053] In some optional embodiments, the artificial valve ring 111 and the grid support 112 are integrally formed. In another optional embodiment, the artificial valve ring 111 and the grid support 112 are separate molded structures, and the two are assembled and connected together after being independently molded. The fixing method between the artificial valve ring 111 and the grid support 112 is not limited, and some optional fixing methods include welding, suturing, riveting, gluing, etc.

[0054] In order to solve the problems of conduction block and coronary artery occlusion in traditional heart stents, the present application improves the support structure 110 so that the support structure 110 also includes a notch A (see the position circled by a dotted line), the notch A includes a first notch 113 and a second notch 114, the first notch 113 is arranged on the artificial valve ring 111, and the second notch 114 is arranged on the grid stent 112. For more details, please refer to Figure 2 The artificial valve ring 111 is an open annular structure, and a first notch 113 is formed between the two circumferential ends of the open annular structure. In some optional embodiments, the artificial valve ring 111 has a substantially arc-shaped structure, which is formed by bending a piece of wire into an open annular structure. Figure 3A second notch 114 is provided on the grid bracket 112 at a position corresponding to the first notch 113 . The first notch 113 and the second notch 114 are basically connected to form an integrated notch A.

[0055] It can be seen that the support structure 110 forms a circumferentially incompletely closed structure at the first end 1101 through the notch A. For some beneficial effects brought by this structure, please refer to Figure 4 and Figure 5 .

[0056] like Figure 4 As described above, when the artificial heart valve 100 provided by the utility model is implanted in the aortic valve, the notch A is aligned with the coronary artery 10, thereby maintaining the patency of the coronary artery, effectively solving the problem of the valve prosthesis blocking the coronary artery after surgery. In addition, for the mitral valve and tricuspid valve, the implantation position of the heart stent is aligned with the atrioventricular node 20 (see Figure 5 ) is very close, and it is easy to come into contact and squeeze with the atrioventricular node 20, causing conduction block; Based on this, taking the tricuspid valve as an example, Figure 5 As described, when the artificial heart valve 100 provided by the utility model is implanted in the tricuspid valve, the notch A is aligned with the atrioventricular node 20, which can prevent the artificial heart valve 100 from contacting and squeezing the atrioventricular node 20, thereby preventing the occurrence of conduction block.

[0057] In this way, the artificial heart valve 100 and its supporting structure 110 provided by the utility model can effectively avoid the risks of postoperative conduction block and coronary artery obstruction by setting the notch A. At the same time, by setting the artificial valve ring 111 at the position of the second notch 114 of the mesh stent 112, the strength lost by the mesh stent 112 due to the second notch 114 can be compensated, thereby playing a better supporting role and ensuring the stability of the structure.

[0058] On the other hand, please refer to Fig.11 The conventional heart stent 200 described has no special structural design, and thus the development image under DSA imaging is relatively symmetrical and uniform. Such an image cannot provide a basis for the valve implantation position, thus increasing the difficulty of surgical operation.

[0059] Specifically in the present application, the notch A can also be used as an image mark to locate the artificial heart valve 100. Fig.12 The image of notch A can be clearly seen under DSA imaging (digital silhouette angiography). Based on the image of notch A, the valve implantation position can be identified, allowing medical staff to more accurately place the artificial heart valve 100 and reduce the difficulty of intraoperative positioning and implantation of the artificial heart valve 100.

[0060] In a further improvement, the presence of the notch A also enables the artificial heart valve 100 to be suitable for patients with more complex mitral and tricuspid valve non-circular annuli, thereby expanding the scope of application and reducing or even eliminating paravalvular leakage.

[0061] Please refer to Figure 6 and Figure 7 Compared with the regular circular structure of the aortic valve, the mitral and tricuspid valve rings (i.e., the native rings 30) both present an irregular "saddle" shaped structure (also referred to as a "D" shaped structure), and the shape of the native rings 30 changes throughout the cardiac cycle. In this regard, the traditional heart stent 200 is prone to regurgitation after implantation. In addition, the applicant has found that the traditional heart stent 200 itself is a completely circumferentially closed annular structure. Even if it is initially designed as a "D" shaped flange anti-valvular leakage structure, the structure itself cannot adapt to the morphological changes of the native rings 30 throughout the cardiac cycle, and cannot be closely attached to the native tissue at any time, which makes paravalvular leakage prone. In short, the native ring 30 only presents an approximately D-shaped structure when the artificial valve leaflet 120 is closed. If the heart stent is designed to be D-shaped from the beginning, it is obviously unable to adapt to the dynamic changes of the native ring 30, which leads to paravalvular leakage.

[0062] To this end, the outer peripheral shape of the support structure 110 provided in the present application preferably matches the shape of the native valve ring 30, and can change with the shape of the native valve ring 30. Here, shape matching mainly includes shape matching during ventricular diastole and ventricular contraction, thereby reducing paravalvular leakage. In a preferred embodiment, the support structure 110 is configured so that the outer peripheral shape is circular when the ventricle is in diastole (see Figure 6 ), and is also configured so that the outer peripheral surface is D-shaped when the ventricle contracts (see Figure 7 ); This is more advantageous for implantation in mitral and tricuspid valves.

[0063] Here, please refer to Figure 6 When the ventricle is in diastole, the native valve ring 30 is circular, and the shape of the artificial heart valve 100 at this time just matches it, which is also circular; please refer to Figure 7When the ventricle contracts, the native valve ring 30 becomes smaller and gradually changes to a "D shape". During this process, since the grid support 112 and the artificial valve ring 111 both have a certain rigidity, they will resist the contraction of the native valve ring 30 and the ventricle, and the gap A will gradually decrease, so that the circumferential ends of the artificial valve ring 111 gradually approach each other, and the part of the artificial heart valve 100 that contacts the native valve ring 30 will also be reduced accordingly. At the same time, the artificial heart valve 100 will be tightly attached to the native tissue due to resisting the native valve ring 30; then, when the ventricle starts to relax again, because the artificial valve ring 111 and the grid support 112 have a certain memory elastic function, they can gradually restore their initial shape in the absence of external force or the weakening of external force. In this way, the artificial heart valve 100 provided in the present application can better follow the changes in the morphology of the native valve ring 30, so that the artificial heart valve 100 can adapt to the changes of the native valve ring 30 during the entire cardiac cycle and adapt to it. It can always be close to the native tissue, and paravalvular leakage is not likely to occur. In addition, the notch A helps the support structure 110 to adapt to the native valve ring 30.

[0064] Return to reference Figure 2 In some optional embodiments, the center angle θ of the first notch 113 is 15°-120°, optionally, 15°, 30°, 45°, 60°, 75°, 90°, 100°, 110°, 120° or other angles. In a preferred embodiment, in combination with actual anatomy, the center angle θ of the first notch 113 is 30°-90°, such as 30°, 60° or 90°. The center angle θ of the first notch 113 is suitable, can ensure the stability of the structure, and can be applied to different patients.

[0065] The second notch 114 can have various shapes and sizes, and the preferred shape is V-shaped or rectangular or other shapes that are easy to process and do not affect the structural stability. Rectangular means a rectangle or a square. Figure 1 and Figure 3 As described in the above, the second notch 114 is generally V-shaped, which not only avoids conduction block and coronary artery occlusion, but also takes into account the structural strength. Therefore, preferably, the width of the second notch 114 along the circumferential extension decreases from the first end 1101 to the second end 1102.

[0066] The maximum width of the second notch 114 extending in the circumferential direction is the same as or different from the width of the first notch 113 extending in the circumferential direction. If the maximum width of the second notch 114 is different from the width of the first notch 113, the width of the first notch 113 extending in the circumferential direction may be smaller than or larger than the maximum width of the second notch 114 extending in the circumferential direction. In a preferred embodiment, the width of the first notch 113 extending in the circumferential direction is the same as the maximum width of the second notch 114 extending in the circumferential direction.

[0067] In some optional embodiments, the maximum width W2 of the second gap 114 is N times the grid width W1 in the grid support 112, where N is a positive integer greater than 1, which facilitates making the gap A by reducing the number of grids. This is explained below by way of example.

[0068] like Figure 8 As shown, in some embodiments, the maximum width W2 of the second notch 114 is twice the grid width W1 in the grid bracket 112 .

[0069] like Fig. 9 As shown, in some embodiments, the maximum width W2 of the second notch 114 is 4 times the grid width W1 in the grid bracket 112 .

[0070] like Fig.10 As shown, in some embodiments, the maximum width W2 of the second notch 114 is 6 times the grid width W1 in the grid bracket 112 .

[0071] Of course, in some other embodiments, the maximum width W2 of the second notch 114 may also be an odd-numbered multiple or other even-numbered multiple of the grid width W1 in the grid bracket 112 .

[0072] It should also be understood that, in addition to the width mentioned above, the notch A should also have a suitable height, which is neither too large to reduce the structural strength and cause leakage, nor too small to achieve the desired effect. Preferably, the height of the notch A extending axially is M times the height of the grid in the grid stent 112, where M is a positive integer greater than or equal to 1. The height of the notch A should be understood as the distance from the lowest point B of the notch A to the artificial valve ring 111. Optionally, the height of the notch A along the axial direction is less than or equal to 80 mm. Preferably, the lowest point B of the notch A does not exceed the outer skirt 132, that is, the notch A is within the coverage of the outer skirt 132 and is not exposed outside the skirt. The grid height is the distance between the two farthest points of a single grid in the axial direction, and the grid width is the distance between the two farthest points of a single grid in the circumferential direction.

[0073] In addition, in order to improve the support of the grid stent 112 for the artificial valve leaflets 120 and to allow the grid stent 112 to have enough positions to sew the artificial valve leaflets 120, in a preferred embodiment, the connection points of two adjacent artificial valve leaflets 120 are aligned with the notch A in the axial direction. Figure 1 In the described situation, the connection point of the two artificial valve leaflets 120 is axially aligned with the lowest point B of the notch A, and the lowest point B is the position closest to the second end 1102. Here, axial alignment means that the connection point of the two adjacent artificial valve leaflets 120 can pass through the notch A, for example, pass through the lowest point B, and have the same circumferential position as the lowest point B if it moves axially.

[0074] As can be understood by those skilled in the art, the artificial leaflet 120 is basically symmetrical as a whole, and includes a leaflet fixed edge, a leaflet free edge, and a leaflet commissure; both ends of the leaflet free edge and the leaflet fixed edge are leaflet commissures, that is, the leaflet commissures are between the two adjacent ends of the leaflet free edge and the leaflet fixed edge. The leaflet fixed edge starts at the leaflet commissure, and the bottom (i.e., the lowest point) of the leaflet fixed edge is the position closest to the inflow end. Therefore, the connection point of the two artificial leaflets 120 is the junction position of the commissures of the two adjacent artificial leaflets 120.

[0075] It should be further explained that, in some embodiments, if the first end 1101 is an inflow end, and the inner surface and / or outer surface of the inflow end is covered with a skirt 130, then the skirt 130 should also be provided with a break corresponding to the notch A. In some other embodiments, if the first end 1101 is an outflow end, and the skirt 130 covers the entire inner surface of the support structure 110, then the skirt 130 is provided with a break at the position of the notch A, otherwise the skirt 130 does not need to be provided with a break. Therefore, the skirt 130 can be selectively provided with a break corresponding to the notch A as needed.

[0076] In summary, the artificial heart valve 100 and its supporting structure 110 of the utility model can reduce the risk of conduction block and coronary artery obstruction by setting the notch A, and can be applied to more complex non-circular patient valve rings, thereby expanding the scope of application. It can also reduce or completely eliminate the paravalvular leak of the mitral and tricuspid valves, and at the same time help to enhance the recognition of intraoperative imaging positioning.

[0077] Although the utility model is disclosed as above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the utility model without departing from the spirit and scope of the utility model. Thus, if these modifications and variations of the utility model fall within the scope of the utility model and its equivalent technology, the utility model is also intended to include these modifications and variations.

Claims

1. A support structure for an artificial heart valve, the support structure having a first end and a second end arranged opposite to each other along its own axial direction, characterized in that: The support structure includes an artificial valve ring arranged at the first end and a grid support axially connected to the artificial valve ring; the artificial valve ring and the grid support are arranged coaxially; the support structure also includes a notch, which includes a first notch and a second notch; the artificial valve ring is an open annular structure to form the first notch between the circumferential ends of the open annular structure; the second notch is provided at a position on the grid support corresponding to the first notch.

2. The support structure of an artificial heart valve according to claim 1, characterized in that: The shape of the outer peripheral surface of the support structure matches the shape of the native valve ring and can change as the morphology of the native valve ring changes.

3. The support structure of an artificial heart valve according to claim 2, characterized in that: The support structure is configured such that the outer peripheral surface of the support structure is circular when the ventricle is in diastole, and is also configured such that the outer peripheral surface of the support structure is D-shaped when the ventricle is in contraction.

4. The support structure of an artificial heart valve according to claim 1, characterized in that: The support structure also has at least one of the following features; The width of the second notch along the circumferential direction decreases from the first end to the second end; The maximum width of the second notch extending in the circumferential direction is the same as or different from the width of the first notch extending in the circumferential direction; The maximum width of the second notch is N times the width of the grid in the grid bracket, where N is a positive integer greater than 1; The height of the notch extending in the axial direction is M times the height of the grid in the grid support, where M is a positive integer greater than or equal to 1.

5. The support structure of an artificial heart valve according to claim 4, characterized in that: The maximum width of the second notch is 2 times, 4 times or 6 times the width of the grid in the grid support.

6. The support structure of an artificial heart valve according to claim 1, characterized in that: The second notch is V-shaped or rectangular.

7. The support structure of an artificial heart valve according to claim 1, characterized in that: The center angle of the first notch is 15°-120°.

8. The support structure of an artificial heart valve according to claim 7, characterized in that: The center angle of the first notch is 30°-90°.

9. An artificial heart valve, characterized in that: A support structure for an artificial heart valve as described in any one of claims 1 to 8 is provided.

10. The artificial heart valve according to claim 9, characterized in that: The notch is axially aligned with a connection point of two adjacent artificial leaflets in the artificial heart valve, and / or the artificial heart valve further includes a skirt, and the skirt is provided with a break corresponding to the notch.

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