Cardiac outflow tract valved patch

Abstract

The present disclosure relates to the field of medical device technology, and specifically to a cardiac outflow tract valved patch, which includes a sinus wall support sheet and a valve leaflet; the lower edge of the valve leaflet is arc-shaped, and the lower edge of the valve leaflet is connected to the sinus wall support sheet, and a valve pocket is formed between the valve leaflet and the sinus wall support sheet; between the upper edge of the valve leaflet and the lower edge of the valve leaflet, an upper edge arm protrudes from the outside of the valve leaflet, and the end of the upper edge arm is used to connect to the sinus wall support sheet. After the heart is repaired with the cardiac outflow tract valved patch in this scheme, as the size of the cardiac outflow tract increases, the extension of the upper edge arm increases accordingly, so that the size of the opening of the valve pocket formed between the valve leaflet and the sinus wall support sheet also increases accordingly, thereby ensuring that the aortic valve will not be incompletely closed.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and in particular to a cardiac outflow tract valved patch. 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 reconstruction of the pulmonary valve structure and function due to the lack of connection between the right ventricle and the pulmonary artery, or extreme stenosis (dysplasia) of the pulmonary valve. Loss of aortic valve function caused by congenital aortic stenosis and acquired aortic valve disease in children requires aortic valve repair. In related technologies, allogeneic valved conduits, porcine valve Dacron conduits, bovine jugular vein conduits, bovine pericardial valved conduits or patches can be used as repair materials for the cardiac outflow tract.

[0003] However, the applicant has found that after the cardiac outflow tract is repaired with the above-mentioned repair material, the size of the cardiac outflow tract will also increase as the patient grows and develops. As a result, since the size of the opening of the valve pocket is fixed, the aortic valve may become incompletely closed, thereby damaging the aortic valve function and requiring the patient to undergo another or multiple surgeries. Therefore, how to ensure that after the cardiac outflow tract is repaired, the aortic valve will not become incompletely closed as the patient grows and develops is a problem that needs to be solved urgently. Summary of the invention

[0004] In order to solve the problems in the related art, an embodiment of the present disclosure provides a cardiac outflow tract valved patch.

[0005] In a first aspect, a cardiac outflow tract valved patch is provided in an embodiment of the present disclosure, wherein the cardiac outflow tract valved patch comprises a sinus wall support piece and a valve leaflet;

[0006] The lower edge of the valve leaflet is arc-shaped, and the lower edge of the valve leaflet is connected to the sinus wall support piece, and a valve pocket is formed between the valve leaflet and the sinus wall support piece;

[0007] An upper edge arm protrudes from the outside of the valve leaflet between the upper edge of the valve leaflet and the lower edge of the valve leaflet, and the end of the upper edge arm is used to be connected to the sinus wall support piece.

[0008] In one embodiment of the present disclosure, the sinus wall support piece and the valve leaflet are integrally formed.

[0009] In one embodiment of the present disclosure, the lower edge of the valve leaflet is sutured to the sinus wall support piece, and the end of the upper edge arm is used to be sutured to the sinus wall support piece.

[0010] In one embodiment of the present disclosure, the sinus wall support sheet and the valve leaflet are homologous tissue sheets, chemically modified heterologous tissue sheets, or artificial material patches.

[0011] In one embodiment of the present disclosure, the chemically modified heterogeneous tissue piece includes an animal pericardium or an aortic valve that has been subjected to an anti-calcification modification.

[0012] In one embodiment of the present disclosure, the sinus wall support piece is rectangular.

[0013] In one embodiment of the present disclosure, the upper edge of the sinus wall support piece extends upward by 1-5 cm from the connection between the end of the upper edge arm and the sinus wall support piece, the side edge of the sinus wall support piece extends laterally by 1-5 cm from the connection between the end of the upper edge arm and the sinus wall support piece, and the lower edge of the sinus wall support piece extends downward by 1-5 cm from the connection between the lower edge of the leaflet and the sinus wall support piece.

[0014] In one embodiment of the present disclosure, the upper edge of the leaflet is a convex structure that gradually decreases from the middle to both ends.

[0015] According to the technical solution provided by the embodiment of the present disclosure, the heart outflow tract valve patch includes a sinus wall support piece and a valve leaflet; the lower edge of the valve leaflet is arc-shaped, and the lower edge of the valve leaflet is connected to the sinus wall support piece, and a valve pocket is formed between the valve leaflet and the sinus wall support piece; an upper edge arm protrudes from the outside of the valve leaflet between the upper edge of the valve leaflet and the lower edge of the valve leaflet, and the end of the upper edge arm is used to connect to the sinus wall support piece. After the heart is repaired based on the above-mentioned heart outflow tract valve patch, as the size of the heart outflow tract increases, the extension of the upper edge arm connected to the sinus wall support piece increases accordingly, so that the size of the opening of the valve pocket formed between the valve leaflet and the sinus wall support piece also increases accordingly, thereby ensuring that the aortic valve will not be incompletely closed.

[0016] 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 present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] 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:

[0018] Figure 1 A front view of a cardiac outflow tract valved patch according to an embodiment of the present disclosure is shown.

[0019] Figure 2 A front view of a leaflet is shown according to an embodiment of the present disclosure.

[0020] Figure 3 A schematic structural diagram showing a leaflet in an expanded state according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0021] 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.

[0022] 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, behaviors, components, parts, or a combination thereof disclosed in the present specification, and are not intended to exclude the possibility that one or more other features, numbers, steps, behaviors, components, parts, or a combination thereof exist or are added.

[0023] It should also be noted that, in the absence of conflict, the embodiments and features in 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.

[0024] In the related art, allogeneic valved conduits, porcine valved Dacron conduits, bovine jugular vein conduits, bovine pericardial valved conduits or patches can be used as repair materials for the cardiac outflow tract.

[0025] However, the applicant has found that after the cardiac outflow tract is repaired with the above-mentioned repair material, the size of the cardiac outflow tract will increase with the growth of the patient. As a result, since the size of the opening of the valve pocket is fixed, the aortic valve may become incompletely closed, thereby damaging the aortic valve function and requiring the patient to undergo another or multiple surgeries.

[0026] Therefore, how to ensure that after the cardiac outflow tract is repaired, the aortic valve will not become incompletely closed as the patient grows and develops is a problem that needs to be solved urgently.

[0027] In order to solve the above problems, the present disclosure provides a cardiac outflow tract valved patch.

[0028] According to the technical solution provided by the embodiment of the present disclosure, the cardiac outflow tract valve patch includes a sinus wall support piece and a valve leaflet; the lower edge of the valve leaflet is arc-shaped, and the lower edge of the valve leaflet is connected to the sinus wall support piece, and a valve pocket is formed between the valve leaflet and the sinus wall support piece; an upper edge arm protrudes from the outside of the valve leaflet between the upper edge of the valve leaflet and the lower edge of the valve leaflet, and the end of the upper edge arm is used to connect to the sinus wall support piece. After the heart is repaired based on the above-mentioned cardiac outflow tract valve patch, as the size of the cardiac outflow tract increases, the extension of the upper edge arm connected to the sinus wall support piece increases accordingly, so that the size of the opening of the valve pocket formed between the valve leaflet and the sinus wall support piece also increases accordingly, thereby ensuring that the aortic valve will not be incompletely closed.

[0029] Figure 1 A front view showing a cardiac outflow tract valved patch according to an embodiment of the present disclosure, Figure 2showing a front view of a leaflet according to an embodiment of the present disclosure, Figure 3 FIG. 2 is a schematic diagram showing a structure of a leaflet in an expanded state according to an embodiment of the present disclosure. Figure 1-Figure 3 As shown, the cardiac outflow tract valved patch comprises: a sinus wall support piece 100 and a valve leaflet 200;

[0030] The lower edge 101 of the leaflet 200 is arc-shaped, and the lower edge 101 of the leaflet 200 is connected to the sinus wall support piece 100, and a valve pocket 103 is formed between the leaflet 200 and the sinus wall support piece 100;

[0031] An upper edge arm 103 protrudes from the outside of the leaflet 200 between the upper edge 102 of the leaflet 200 and the lower edge 101 of the leaflet 200 , and the end of the upper edge arm 103 is used to connect with the sinus wall support piece 100 .

[0032] In one embodiment of the present disclosure, the sinus wall support sheet and the valve leaflet are homologous tissue sheets, chemically modified heterologous tissue sheets, or artificial material patches.

[0033] In one embodiment of the present disclosure, the chemically modified heterogeneous tissue piece includes an animal pericardium or an aortic valve that has been subjected to an anti-calcification modification.

[0034] According to the technical solution provided by the embodiment of the present disclosure, the cardiac outflow tract valve patch includes a sinus wall support piece and a valve leaflet; the lower edge of the valve leaflet is arc-shaped, and the lower edge of the valve leaflet is connected to the sinus wall support piece, and a valve pocket is formed between the valve leaflet and the sinus wall support piece; an upper edge arm protrudes from the outside of the valve leaflet between the upper edge of the valve leaflet and the lower edge of the valve leaflet, and the end of the upper edge arm is used to connect to the sinus wall support piece. After the heart is repaired based on the above-mentioned cardiac outflow tract valve patch, as the size of the cardiac outflow tract increases, the extension of the upper edge arm connected to the sinus wall support piece increases accordingly, so that the size of the opening of the valve pocket formed between the valve leaflet and the sinus wall support piece also increases accordingly, thereby ensuring that the aortic valve will not be incompletely closed.

[0035] In one embodiment of the present disclosure, the sinus wall support piece and the valve leaflet are integrally formed.

[0036] Exemplarily, the sinus wall support piece and the valve leaflet can be integrally formed based on additive manufacturing technology or the like.

[0037] In this technical solution, the structural strength of the heart outflow tract valved patch can be increased by integrally molding the sinus wall support sheet and the valve leaflet.

[0038] In one embodiment of the present disclosure, the lower edge of the valve leaflet is sutured to the sinus wall support piece, and the end of the upper edge arm is used to be sutured to the sinus wall support piece.

[0039] In this technical solution, by using the lower edge of the valve leaflet to sew with the sinus wall support piece and the end of the upper edge arm to sew with the sinus wall support piece, the processing difficulty of the heart outflow tract valved patch can be reduced and the manufacturing cost can be reduced.

[0040] In one embodiment of the present disclosure, the sinus wall support piece is rectangular.

[0041] Exemplarily, the upper edge of the sinus wall support piece can extend upward by 1-5 cm from the connection between the end of the upper edge arm and the sinus wall support piece, the side edge of the sinus wall support piece can extend laterally by 1-5 cm from the connection between the end of the upper edge arm and the sinus wall support piece, and the lower edge of the sinus wall support piece can extend downward by 1-5 cm from the connection between the lower edge of the leaflet and the sinus wall support piece.

[0042] In this technical solution, by making the sinus wall support piece into a rectangular shape, it is convenient to cut the sinus wall support piece later.

[0043] In one embodiment of the present disclosure, the upper edge of the leaflet is a convex structure that gradually decreases from the middle to both ends.

[0044] In this technical solution, by making the upper edge of the leaflet a convex structure that gradually descends from the middle to both ends, the leaflet can be made closer to the shape of the aortic valve in the human body, so that the leaflet can be better anastomosed with other aortic valves.

[0045] The above description is only a preferred embodiment of the present disclosure and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the present disclosure is not limited to the technical solution formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the above features are replaced with the technical features with similar functions disclosed in the present disclosure (but not limited to) by each other.

Claims

1. A cardiac outflow tract valved patch, characterized in that: The cardiac outflow tract valved patch comprises a sinus wall support piece and a valve leaflet; The lower edge of the valve leaflet is arc-shaped, and the lower edge of the valve leaflet is connected to the sinus wall support piece, and a valve pocket is formed between the valve leaflet and the sinus wall support piece; 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 support sheet; The cardiac outflow tract valved patch is used to repair the heart, ensuring that in the repaired heart, as the size of the cardiac outflow tract increases, the extension of the upper edge arm increases accordingly, thereby increasing the size of the opening of the valve pocket formed between the valve leaflet and the sinus wall support plate.

2. The cardiac outflow tract valved patch according to claim 1, characterized in that: The sinus wall support piece is integrally formed with the valve leaflet.

3. The cardiac outflow tract valved patch according to claim 1, characterized in that: The lower edge of the leaflet is sutured to the sinus wall support piece, and the end of the upper edge arm is used for sutured to the sinus wall support piece.

4. The cardiac outflow tract valved patch according to claim 1, characterized in that: The sinus wall support sheet and the valve leaflet are homologous tissue sheets, chemically modified heterologous tissue sheets or artificial material patches.

5. The cardiac outflow tract valved patch according to claim 4, characterized in that: The chemically modified heterogeneous tissue piece comprises an animal pericardium or an aortic valve that has been subjected to an anti-calcification modification.

6. The cardiac outflow tract valved patch according to claim 1, characterized in that: The sinus wall supporting piece is rectangular.

7. The cardiac outflow tract valved patch according to claim 6, characterized in that: The upper edge of the sinus wall support piece extends upward by 1-5 cm from the connection between the end of the upper edge arm and the sinus wall support piece, the side edge of the sinus wall support piece extends laterally by 1-5 cm from the connection between the end of the upper edge arm and the sinus wall support piece, and the lower edge of the sinus wall support piece extends downward by 1-5 cm from the connection between the lower edge of the leaflet and the sinus wall support piece.

8. The cardiac outflow tract valved patch 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.

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