Artificial aortic valve sinus complex

Abstract

The present disclosure relates to the field of medical device technology, and more specifically, to an artificial aortic valve sinus complex. The artificial aortic valve sinus complex comprises a leaflet lower edge skirt and leaflets. One side of the leaflet lower edge skirt is adapted to abut and connect to the valve annulus, while the leaflet lower edge is coupled to the other side of the leaflet lower edge skirt to form a valve pocket between the leaflet and the sinus wall. This solution reduces the operational difficulty of aortic valve replacement and improves the success rate of replacement.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and in particular to an artificial aortic valve sinus complex. Background Art

[0002] Complex congenital heart diseases such as pulmonary atresia, tetralogy of Fallot (double outlet right ventricle) with severe pulmonary artery stenosis, complex transposition of the great arteries, and common arterial trunk often require valve replacement due to a lack of connection between the right ventricle and the pulmonary artery, or extreme stenosis (hypoplasia) of the pulmonary valve. Furthermore, loss of aortic valve function due to congenital aortic stenosis and acquired aortic valve disease in children also requires valve replacement. In related technologies, artificial valve materials can be formed by cutting and sewing autologous pericardial sheets or bovine pericardial patches, allowing them to be used during surgery to replace the aortic valve.

[0003] However, the applicant found that since the shape of the above-mentioned artificial aortic valve material is relatively simple, during surgery, the doctor often needs to cut the artificial aortic valve material first, and then use the cut artificial aortic valve to replace the aortic valve. In this process, it is also necessary to ensure that the shape of the valve pocket formed after replacement is close to the shape of the valve pocket in the human body, so as to ensure that the opening and closing functions of the artificial aortic valve after replacement are perfect, thereby increasing the difficulty of the operation of replacing the aortic valve and reducing the success rate of the replacement. Summary of the Invention

[0004] In order to solve the problems in the related art, an embodiment of the present disclosure provides an artificial aortic valve sinus complex.

[0005] In a first aspect, an embodiment of the present disclosure provides an artificial aortic valve sinus complex, the artificial aortic valve sinus complex comprising a valve leaflet lower edge skirt and a valve leaflet;

[0006] One side of the skirt at the lower edge of the leaflet is used to adhere to and connect with the annulus;

[0007] The lower edge of the leaflet is connected to the other side of the skirt of the lower edge of the leaflet to form a valve pocket between the leaflet and the sinus wall.

[0008] In one embodiment of the present disclosure, an upper edge arm protrudes from the outside of the leaflet between the upper edge of the leaflet and the lower edge of the leaflet, and the end of the upper edge arm is used to connect with the sinus wall.

[0009] In one embodiment of the present disclosure, the artificial arterial valve sinus complex further includes an upper arm skirt, one side of the upper arm skirt is connected to the end of the upper arm, and the other side of the upper arm skirt is used to connect to the sinus wall.

[0010] In one embodiment of the present disclosure, the leaflet and the skirt at the lower edge of the leaflet are integrally formed;

[0011] Alternatively, the lower edge of the leaflet is sutured to the other side of the skirt of the lower edge of the leaflet.

[0012] In one embodiment of the present disclosure, the leaflet, the leaflet lower edge skirt and the upper edge arm skirt are integrally formed;

[0013] Alternatively, the lower edge of the leaflet is sutured to the other side of the skirt of the lower edge of the leaflet, and one side of the skirt of the upper edge arm is sutured to the end of the upper edge arm.

[0014] In one embodiment of the present disclosure, the leaflet, the lower edge skirt of the leaflet and the upper edge arm skirt are homologous tissue sheets, chemically modified heterologous tissue sheets or artificial material patches.

[0015] In one embodiment of the present disclosure, the chemically modified xenogeneic tissue piece includes an animal pericardium and an aortic valve that have been treated with anti-calcification modification.

[0016] In one embodiment of the present disclosure, the upper edge of the leaflet is a raised structure that gradually decreases from the middle to both ends.

[0017] In one embodiment of the present disclosure, the artificial arterial valve sinus complex further includes an artificial sinus wall connected to the lower edge skirt of the valve leaflet, and the artificial sinus wall is used to adhere to the sinus wall.

[0018] In one embodiment of the present disclosure, the lower edge skirt of the valve leaflet is connected to the artificial sinus wall via a detachable structure.

[0019] According to the technical solution provided by the embodiment of the present disclosure, the artificial arterial valve sinus complex includes a leaflet lower edge skirt and a leaflet, one side of the leaflet lower edge skirt is used to abut and connect to the valve annulus, and the lower edge of the leaflet is connected to the other side of the leaflet lower edge skirt, which is used to form a valve pocket between the leaflet and the sinus wall. In the operation, the doctor only needs to cut the leaflet lower edge skirt according to the shape of the valve annulus, and then abut and connect one side of the leaflet lower edge skirt to the valve annulus to form a valve pocket between the leaflet and the sinus wall. The shape of the valve pocket has been formed before the replacement, and the shape is relatively close to the shape of the valve pocket in the human body, which can ensure that the opening and closing functions of the artificial arterial valve sinus complex are perfect after the replacement. Therefore, this solution reduces the difficulty of the operation of the aortic valve replacement, thereby improving the success rate of the replacement.

[0020] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Other features, objectives and advantages of the present disclosure will become more apparent through the following detailed description of non-limiting embodiments in conjunction with the accompanying drawings. In the accompanying drawings:

[0022] Figure 1 A front view of a prosthetic aortic valve sinus complex according to an embodiment of the present disclosure is shown.

[0023] Figure 2 A top view of a prosthetic aortic valve sinus complex according to an embodiment of the present disclosure is shown.

[0024] Figure 3 A longitudinal cross-sectional view of a prosthetic aortic valve sinus complex according to an embodiment of the present disclosure is shown.

[0025] Figure 4 A front view of a prosthetic aortic valve sinus complex according to an embodiment of the present disclosure is shown.

[0026] Figure 5 A top view of a prosthetic aortic valve sinus complex according to an embodiment of the present disclosure is shown.

[0027] Figure 6 A longitudinal cross-sectional view of a prosthetic aortic valve sinus complex according to an embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0028] Hereinafter, exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings so that those skilled in the art can easily implement them. In addition, for the sake of clarity, parts not related to the description of the exemplary embodiments are omitted in the accompanying drawings.

[0029] In the present disclosure, it should be understood that terms such as "include" or "have" are intended to indicate the presence of features, numbers, steps, actions, components, parts, or combinations thereof disclosed in the present specification, and are not intended to exclude the possibility that one or more other features, numbers, steps, actions, components, parts, or combinations thereof exist or are added.

[0030] It should also be noted that, in the absence of conflict, the embodiments and features of the embodiments of the present disclosure may be combined with each other. The present disclosure will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0031] In this disclosure, if it involves operations of obtaining user information or user data or displaying user information or user data to others, such operations are all authorized and confirmed by the user, or actively selected by the user.

[0032] In the related art, when replacing an aortic valve, an autologous pericardium sheet or a bovine pericardium patch can be cut and sewn to form an artificial aortic valve material, so that the artificial aortic valve material can be used to replace the aortic valve during surgery.

[0033] However, the applicant found that since the shape of the above-mentioned artificial aortic valve material is relatively simple, during surgery, the doctor often needs to cut the artificial aortic valve material first, and then use the cut artificial aortic valve to replace the aortic valve. In this process, it is also necessary to ensure that the shape of the valve pocket formed after replacement is close to the shape of the valve pocket in the human body, so as to ensure that the opening and closing functions of the cut artificial aortic valve are perfect after replacement.

[0034] For example, the artificial aortic valve sinus complex material formed by cutting and sewing an autologous pericardial sheet or a bovine pericardial patch is usually square in shape. During the operation, the doctor needs to first cut the square artificial aortic valve sinus complex material to obtain an artificial aortic valve sinus complex that is closer to the shape of the leaflets of the aortic valve. During the replacement, the doctor manually sets the shape of the artificial aortic valve sinus complex to form a valve pocket between the artificial aortic valve sinus complex and the sinus wall, so that the shape of the valve pocket is closer to the shape of the valve pocket in the human body, so as to ensure that the opening and closing functions of the cut artificial aortic valve sinus complex are perfect after replacement.

[0035] Therefore, the above scheme increases the difficulty of the aortic valve replacement operation and reduces the success rate of the replacement.

[0036] To solve the above-mentioned problems, the technical solution provided by the embodiments of the present disclosure provides an artificial aortic valve sinus complex, the artificial aortic valve sinus complex comprising a leaflet lower edge skirt and a leaflet, wherein one side of the leaflet lower edge skirt is used to abut and connect with the valve annulus, and the lower edge of the leaflet is connected to the other side of the leaflet lower edge skirt, so as to form a valve pocket between the leaflet and the sinus wall. In particular, during surgery, since the doctor only needs to cut the leaflet lower edge skirt according to the shape of the valve annulus, and then abut and connect one side of the leaflet lower edge skirt with the valve annulus, a valve pocket can be formed between the leaflet and the sinus wall. The shape of the valve pocket is formed before replacement, and the shape is relatively close to the shape of the valve pocket in the human body, which can ensure that the opening and closing functions of the artificial aortic valve sinus complex are perfect after replacement. Therefore, this solution reduces the difficulty of performing aortic valve replacement, thereby improving the success rate of replacement.

[0037] Figure 1 A front view showing an artificial aortic valve sinus complex according to an embodiment of the present disclosure, Figure 2 A top view of an artificial aortic valve sinus complex according to an embodiment of the present disclosure is shown; Figure 3 FIG. 1 shows a longitudinal cross-sectional view of an artificial aortic valve sinus complex according to an embodiment of the present disclosure. Figure 1-Figure 3As shown, the artificial aortic valve sinus complex includes a leaflet lower edge skirt 100 and a leaflet 200; one side of the leaflet lower edge skirt 100 is used to adhere to the valve annulus and be connected to the valve annulus; the lower edge 201 of the leaflet 200 is connected to the other side of the leaflet lower edge skirt 100, and is used to form a valve pocket 301 between the leaflet 200 and the sinus wall 300.

[0038] In one implementation of the present disclosure, the leaflet and the lower edge skirt of the leaflet are integrally formed; or, the lower edge of the leaflet and the other side of the lower edge skirt of the leaflet are sutured.

[0039] In one embodiment of the present disclosure, the leaflets and the lower edge of the leaflets can be homologous tissue sheets, chemically modified heterologous tissue sheets, or artificial material patches. The chemically modified heterologous tissue sheets include animal pericardium and aortic valves that have been treated with anti-calcification treatment.

[0040] In the technical solution provided by the embodiment of the present disclosure, the artificial arterial valve sinus complex includes a leaflet lower edge skirt and a leaflet, one side of the leaflet lower edge skirt is used to abut and connect to the valve annulus, and the lower edge of the leaflet is connected to the other side of the leaflet lower edge skirt, which is used to form a valve pocket between the leaflet and the sinus wall. In particular, since during surgery, the doctor only needs to cut the leaflet lower edge skirt according to the shape of the valve annulus, and then abut and connect one side of the leaflet lower edge skirt to the valve annulus, a valve pocket can be formed between the leaflet and the sinus wall. The shape of the valve pocket has been formed before replacement, and the shape is relatively close to the shape of the valve pocket in the human body, which can ensure that the opening and closing functions of the artificial arterial valve sinus complex are perfect after replacement. Therefore, this solution reduces the difficulty of the operation of replacing the aortic valve, thereby improving the success rate of replacement.

[0041] In one embodiment of the present disclosure, Figure 4 FIG2 shows a front view of an artificial aortic valve sinus complex according to an embodiment of the present disclosure. Figure 4 As shown, an upper edge arm 400 protrudes from the outside of the leaflet 200 between the upper edge 202 of the leaflet 200 and the lower edge 201 of the leaflet 200 , and the end of the upper edge arm 400 is used to connect with the sinus wall 300 .

[0042] In the above technical solution, after the aortic valve is replaced based on the artificial aortic valve sinus complex, as the diameter of the artery increases, the extension of the upper edge arm increases accordingly, so that the size of the valve pocket opening also increases accordingly, thereby ensuring that the artificial aortic valve sinus complex will not have incomplete closure.

[0043] In one embodiment of the present disclosure, Figure 4As shown, the artificial arterial valve sinus complex further includes an upper arm skirt 500 , one side of which is connected to the end of the upper arm 400 , and the other side of which is used to connect to the sinus wall 300 .

[0044] In one embodiment of the present disclosure, the leaflet, the leaflet lower edge skirt and the upper edge arm skirt are integrally formed;

[0045] Alternatively, the lower edge of the leaflet is sutured to the other side of the skirt of the lower edge of the leaflet, and one side of the skirt of the upper edge arm is sutured to the end of the upper edge arm.

[0046] In one embodiment of the present disclosure, the leaflet, the lower edge skirt of the leaflet and the upper edge arm skirt are homologous tissue sheets, chemically modified heterologous tissue sheets or artificial material patches.

[0047] In one embodiment of the present disclosure, the chemically modified xenogeneic tissue piece includes an animal pericardium and an aortic valve that have been treated with anti-calcification modification.

[0048] In the above technical solution, when replacing the aortic valve based on the artificial aortic valve sinus complex, the doctor can directly attach and connect the other side of the upper arm skirt to the sinus wall, thereby reducing the difficulty of the operation when replacing the aortic valve and improving the success rate of the replacement.

[0049] In one embodiment of the present disclosure, the upper edge of the leaflet is a raised structure that gradually decreases from the middle to both ends.

[0050] In this technical solution, by making the upper edge of the valve leaflet a raised structure that gradually descends from the middle to both ends, the artificial aortic valve sinus complex can be made closer to the shape of the aortic valve in the human body, and the closure condition of the artificial aortic valve sinus complex and other autologous aortic valves can be better.

[0051] In one embodiment of the present disclosure, Figure 5 A top view of an artificial aortic valve sinus complex according to an embodiment of the present disclosure is shown; Figure 6 FIG. 1 shows a longitudinal cross-sectional view of an artificial aortic valve sinus complex according to an embodiment of the present disclosure. Figure 5-6 As shown, the artificial arterial valve sinus complex further includes an artificial sinus wall 600 detachably connected to the lower edge skirt 100 of the valve leaflet, and the artificial sinus wall 600 is used to adhere to the sinus wall.

[0052] In one implementation of the present disclosure, multiple breakpoints can be set along the connecting line between the artificial sinus wall and the lower edge of the leaflet skirt, so that a tear line structure is formed along the connecting line, so that the two can be torn along the tear line structure during surgery to separate the two; alternatively, the artificial sinus wall and the lower edge of the leaflet skirt can be bonded so that the two can be separated during surgery.

[0053] The lower edge of the leaflet skirt 100 and the artificial sinus wall 600 can be integrally formed. After suturing, the artificial sinus wall 600 can be cut away along the valve annulus. When used to replace the left and right coronary valves, the artificial sinus wall 600 needs to be removed. When used to replace a noncoronary valve or a pulmonary valve, the artificial sinus wall can be retained and used to reinforce the native sinus wall.

[0054] In the above technical solution, the artificial arterial valve sinus complex also includes an artificial sinus wall that is detachably connected to the lower edge of the valve leaflet skirt, and the artificial sinus wall is used to adhere to the sinus wall. Before the operation, the artificial sinus wall can fix the shape of the lower edge of the valve leaflet skirt, so that the shape of the artificial arterial valve sinus complex is not easily deformed, further ensuring that the shape of the artificial arterial valve sinus complex is closer to the shape of the valve pocket in the human body, so that the opening and closing functions of the artificial arterial valve sinus complex after replacement are perfect; and during the operation, after the doctor adheres the artificial sinus wall to the sinus wall and adheres and connects one side of the lower edge of the valve leaflet skirt to the sinus wall, the artificial sinus wall can be separated from the lower edge of the valve leaflet skirt, thereby not affecting the normal function of the artificial arterial valve sinus complex.

[0055] The above description is merely a preferred embodiment of the present disclosure and an illustration of the technical principles employed. Those skilled in the art should understand that the scope of the invention herein is not limited to technical solutions formed by specific combinations of the aforementioned technical features. It also encompasses other technical solutions formed by any combination of the aforementioned technical features or their equivalents, without departing from the inventive concept. For example, a technical solution formed by replacing the aforementioned features with (but not limited to) technical features with similar functions disclosed in this disclosure.

Claims

1. An artificial aortic valve sinus complex, characterized in that: The artificial arterial valve sinus complex includes a valve leaflet lower edge skirt and a valve leaflet; One side of the lower edge of the leaflet skirt is used to adhere to the valve ring and be connected to the valve ring; The lower edge of the leaflet is connected to the other side of the skirt of the lower edge of the leaflet, so as to form a leaflet pocket between the leaflet and the sinus wall; An upper edge arm protrudes from the outside of the leaflet between the upper edge of the leaflet and the lower edge of the leaflet, the end of the upper edge arm is used to connect with the sinus wall, and the extension of the upper edge arm increases with the increase of the diameter of the artery; The artificial arterial valve sinus complex further includes an upper arm skirt, one side of the upper arm skirt is connected to the end of the upper arm, and the other side of the upper arm skirt is used to connect to the sinus wall.

2. The artificial aortic valve sinus complex according to claim 1, characterized in that: The leaflet and the skirt at the lower edge of the leaflet are integrally formed; Alternatively, the lower edge of the leaflet is sutured to the other side of the skirt of the lower edge of the leaflet.

3. The artificial aortic valve sinus complex according to claim 1, characterized in that: The leaflet, the leaflet lower edge skirt and the upper edge arm skirt are integrally formed; Alternatively, the lower edge of the leaflet is sutured to the other side of the lower edge skirt of the leaflet, and one side of the upper edge arm skirt is sutured to the end of the upper edge arm.

4. The artificial aortic valve sinus complex according to claim 1, characterized in that: The leaflet, the leaflet lower edge skirt and the upper edge arm skirt are homogeneous tissue pieces, chemically modified heterogeneous tissue pieces or artificial material patches.

5. The artificial aortic valve sinus complex according to claim 4, characterized in that: The chemically modified heterogeneous tissue piece comprises animal pericardium and arterial valve that have been subjected to anti-calcification modification.

6. The artificial aortic valve sinus complex according to claim 1, characterized in that: The upper edge of the leaflet is a convex structure that gradually descends from the middle to both ends.

7. The artificial aortic valve sinus complex according to claim 1, characterized in that: The artificial arterial valve sinus complex further comprises an artificial sinus wall connected to the lower edge skirt of the valve leaflet, and the artificial sinus wall is used to adhere to the sinus wall.

8. The artificial aortic valve sinus complex according to claim 7, characterized in that: The lower edge skirt of the valve leaflet is connected to the artificial sinus wall via a detachable structure.

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