The invention relates to the technical field of medical instruments, in particular to a connecting structure of a stent and a valve leaflet for interventional pulmonary valves and interventional aortic valves, and an interventional pulmonary valve and an interventional aortic valve applying the connecting structure.
The first report of success in transcatheter pulmonary valve intervention was in 2000, a valve known as Melody™ transcatheter pulmonary valve (shown in
China is a large country with nearly 1.4 billion people. There are nearly 1 million children with birth defects each year, involving pulmonary valve birth defects, belonging to complex congenital heart disease (referred to as complex CHD). According to “Report on Cardiovascular Disease in China (2017)”, 200 million patients with congenital heart disease in China, about ⅕ of them have complex congenital heart disease. For most of these children, surgical reconstruction of the pulmonary valve and the main pulmonary artery is the only effective treatment. In order to solve this problem, the applicant has a patent entitled “Artificial Pulmonary Artery Valved Duct (ZL 200710064337.9)” for cardiac surgery implantation to reconstruct the right ventricular outflow tract and pulmonary valve, which was approved for registration and marketing in December 2016. Similar inventions include “valved patches for cardiac outflow tract” (ZL 200510082673.7), “valved patches and valved conduits for repair of cardiac outflow tract (U.S. Pat. No. 11/995,106)” and “stentless artificial bioprosthetic valve (ZL 200510082674.1)”.
In view of the problem of durability which is generally concerned with the clinical application of the interventional valve at present, the current research on the durability of the interventional pulmonary valve in the industry patent is still in the initial stage.
In view of this, the technical problem to be solved by the present invention is to provide a connecting structure of a stent and valve leaflet for interventional pulmonary valves and interventional aortic valves, and an interventional pulmonary valve and an interventional aortic valve using the connecting structure, wherein a cushioning portion is arranged on the inner side of a metal stent, so that the valve leaflets can be prevented from being in direct contact with the stent, and the service durability of a valve product is improved.
In order to solve the technical problem, the technical scheme adopted by the invention is to provide a connecting structure of a stent and valve leaflets for interventional pulmonary valves and interventional aortic valves, wherein the stent is a metal mesh tube, the valve leaflets are three fan-shaped valve leaflets arranged on the inner side of the stent, each of the three fan-shaped valve leaflets is provided with a free edge, an arc-shaped bottom edge and valve leaflet junction connecting parts extending on two sides, and three connecting posts are uniformly distributed on the metal mesh tube; and the junction connecting parts on the two sides of each valve leaflet are folded on the inner side of each connecting post to form a cushioning portion, and then are connected and fixed to the connecting posts through sutures.
Furthermore, double columns of holes or double columns of rectangular frames are arranged on each connecting post, the number of the holes is four to eight, and the number of the rectangular frames is two or four.
Furthermore, the junction connecting part is folded once or twice to form the cushioning portion and connected and fixed to the hole or the rectangular frame of the connecting post through sutures.
Furthermore, the material of the stent is an implantable alloy material, the implantable alloy material is a cobalt-based alloy, a nickel-titanium alloy or a stainless steel material, and the material of the valve leaflet is an animal-derived tissue material or a medical polymer material.
The invention also provides an interventional pulmonary valve applying the above connecting structure, which comprises a stent being radially compressible and self-expandable with two ends in a uniform cylindrical flaring shape, three fan-shaped valve leaflets arranged on the inner side of the stent, the three fan-shaped valve leaflets are respectively provided with a free edge, an arc-shaped bottom edge and valve leaflet junction connecting parts extending on the two sides, the stent is a metal mesh tube, and three connecting posts are uniformly distributed on the metal mesh tube; and the junction connecting parts on the two sides of each valve leaflet are folded on the inner side of each connecting post to form a cushioning portion, then are connected and fixed to the connecting posts through sutures, and a coating membrane is arranged on the wall body of the stent.
Furthermore, double columns of holes or double columns of rectangular frames are arranged on each connecting post, the number of the holes is four to eight, and the number of the rectangular frames is two or four. Further, the junction connecting part is folded once or twice to form the cushioning portion and connected and fixed to the hole or the rectangular frame of the connecting post through sutures. Furthermore, the material of the stent is an implantable alloy material, the implantable alloy material is a cobalt-based alloy, a nickel-titanium alloy or a stainless steel material, and the material of the valve leaflet is an animal-derived tissue material or a medical polymer material.
Furthermore, the stent is provided with a plurality of columns of axial supporting rods arranged between the connecting posts, six rows of transversely extending circumferential supporting rods are arranged between the connecting posts and the axial supporting rods, the lower first, second and third rows of circumferential supporting rods define the inflow end of the stent, the fourth, fifth and sixth rows of circumferential supporting rods define the outflow end of the stent, and each row of circumferential supporting rods consists of a plurality of groups of angular supporting rods connected together; each group of supporting rods is in the shape of a deformable V, the deformation angle is 0-90 degrees, each row of circumferential supporting rods and a plurality of columns of axial supporting rods form a plurality of rows of rhombic or honeycomb grids, and a coating membrane on the body wall of the stent is sewn to the grids in the middle row of the stent. Further, the angle between the outer edge of the balloon-expanded stent and its axis is between 0° and 30°.
The invention also provides an interventional aortic valve applying the above connecting structure, which comprises a sent that can be radially compressible and in a slightly flaring shape after being expanded by a balloon, three fan-shaped valve leaflets arranged on the inner side of the stent, the three fan-shaped valve leaflets are respectively provided with a free edge, an arc-shaped bottom edge and valve leaflet junction connecting parts extending on the two sides, the stent is a metal mesh tube, and three connecting posts are uniformly distributed on the metal mesh tube; and the junction connecting parts on the two sides of each valve leaflet are folded on the inner side of each connecting post to form a cushioning portion, then are connected and fixed to each of the connecting posts through sutures, and a coating membrane is arranged on the body wall of the stent.
Furthermore, double columns of holes or double columns of rectangular frames are arranged on each connecting post, the number of the holes is four to eight, and the number of the rectangular frames is two or four. Further, the junction connecting part is folded once or twice to form the cushioning portion and connected and fixed to the hole or the rectangular frame of the connecting post through sutures. Furthermore, the material of the stent is an implantable alloy material, the implantable alloy material is a cobalt-based alloy, a nickel-titanium alloy or a stainless steel material, and the material of the valve leaflet is an animal-derived tissue material or a medical polymer material.
Furthermore, the stent is provided with a plurality of columns of axial supporting rods arranged between the connecting posts, three rows of transversely extending circumferential supporting rods are arranged between the connecting posts and the axial supporting rods, the lower first row of circumferential supporting rods define the inflow end of the stent, the second row of circumferential supporting rods and the third row of circumferential supporting rods spaced from the first row define an outflow end of the stent, and each row of circumferential supporting rods consists of a plurality of groups of angular supporting rods connected together; each group of supporting rods is in the shape of a deformable V, the deformation angle is 0-90 degrees, each group of circumferential supporting rods in the first row and the second row are arranged in parallel and opposite to the direction of each group of circumferential supporting rods in the third row, and a coating membrane on the body wall of the stent is sewn between the first row of circumferential supporting rods and the second row of circumferential supporting rods.
Furthermore, the stent is provided with four rows of transversely extending circumferential supporting rods and a plurality of columns of axial supporting rods arranged between the circumferential supporting rods, wherein the lower first and second row of circumferential supporting rods define the inflow end of the stent, the third and fourth row of circumferential supporting rods define the outflow end of the stent, each row of circumferential supporting rods consists of a plurality of groups of angular supporting rods connected together, and each group of supporting rods is in a deformable V shape; the deformation angle is 0-90 degrees, a plurality of columns of axial supporting rods and a plurality of groups of circumferential supporting rods are mutually connected to form a honeycomb space, and a coating membrane on the body wall of the stent is sewn between the first row of circumferential supporting rods and the third row of circumferential supporting rods.
Further, a coating membrane is sewn between the first row of circumferential supporting rods and the second row of circumferential supporting rods outside the body wall of the stent.
Further, the angle between the outer edge of the balloon-expanded stent and its axis is between 0° and 30°.
The invention has the beneficial effects that: the invention provides a connecting structure of a stent and valve leaflets for interventional pulmonary valves and interventional aortic valves, and an interventional aortic valve and an interventional pulmonary valve applying the connecting structure. Due to the fact that the animal-derived tissue material is folded at the inner side of the valve leaflet junction connection tissue to form a cushioning portion, and then the cushioning portion is connected and fixed on the connecting post of the stent through sutures, the valve leaflets can be prevented from being rubbed or scratched by the metal stent in the opening and closing processes; and due to the fact that the connecting posts in the connecting structure are double rows of holes or rectangular frame routing, the sutures at the seams of the junction connecting parts of the valve leaflets are fully fixed with the holes or the rectangular frame, stress concentration of the valve leaflets in the opening and closing processes can be avoided, use durability of the interventional aortic valve or the interventional pulmonary valve is improved, and a durable effect equivalent to that of a surgical valve is achieved. On the basis of the original product, the artificial biological pulmonary valve is implanted in a minimally invasive catheter-passing mode in the pulmonary valve of the present application, and particularly, for adult patients with complex cardiac surgery who have been operated to reconstruct the right ventricular outflow tract for many years, they can be treated without another thoracic surgery. The invention aims to design a valve stent, in particular to a connecting structure of the stent and a valve leaflet, and based on the experience of successful application of a surgical bioprosthetic valve previously, the connection and fixation of the valve leaflet and the stent are key points of firmness and durability of an interventional artificial bioprosthetic valve. In this manner, an interventional pulmonary valve having hemodynamic characteristics and durability consistent with the surgical artificial bioprosthetic valve of the enterprise will be obtained by the present invention. Meanwhile, the invention can also be used for sewing an interventional aortic valve.
The present invention provides a connecting structure of a stent and a valve leaflet for an interventional aortic valve or an interventional pulmonary valve, and an interventional aortic valve and an interventional pulmonary valve using the connecting structure. The following detailed description illustrates specific embodiments with the understanding that the specific embodiments described herein are merely illustrative of the invention and are not intended to be limiting thereof. The connecting structure of the stent and the valve leaflet can be used for interventional pulmonary valves and interventional aortic valves.
The interventional aortic valve has a “lower” end and an “upper” end. In the context of this application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, the lower end of the interventional aortic valve is its inflow end and the upper end of the interventional aortic valve is its outflow end.
Referring to
Referring again to
When the valve leaflets of the interventional aortic valve are opened, due to the existence of the cushioning portion 24, the valve leaflets can be prevented from being rubbed or scratched by the metal stent in the opening and closing processes; and due to the fact that the connecting posts in the connecting structure are double rows of holes routing, the sutures at the seams of the junction connecting parts of the valve leaflets are fully fixed with the holes or the rectangular frame, stress concentration of the valve leaflets in the opening and closing processes can be avoided, use durability of the interventional aortic valve or the interventional pulmonary valve is improved, and a durable effect equivalent to that of a surgical valve is achieved.
The interventional aortic valve of the example has a stent structure different from that of Example 1, and other structures are substantially the same as those of Example 1. In some cases, a larger outflow end and a larger stent height are required. Referring to
Interventional pulmonary valves are commonly used for interventional therapy of the right ventricular outflow tract.
The interventional pulmonary valve of the present example is mainly different from the interventional aortic valves of Examples 1 and 2 of the present invention in that the shape of the stent is different. Referring to
The connecting post 61 of the interventional pulmonary valve of the example is of a double-row hole design, and the fan-shaped valve leaflets can be fixed to the stent in the same connection manner as in the Example 1.
The stent in all examples may be implemented as, but is not limited to, a cobalt-based alloy or nickel-titanium alloy or stainless steel material or other implantable alloy material stent or the like, and is not specifically limited thereto; the valve leaflet is an animal-derived tissue material or a medical polymer material, for example, any one of a porcine pericardium, a bovine pericardium or a sheep pericardium tissue material or any one of medical polymer materials, and is not specifically limited thereto. The suture is any one of medical polymer materials.
Finally, it should be noted that: the above examples are merely illustrative of the technical solutions of the present invention and are not intended to be limiting thereof; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art will appreciate that: the technical solutions of the above-mentioned embodiments can still be modified, or some or all of the technical features thereof can be equivalently replaced; these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.
Number | Date | Country | Kind |
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201910274554.3 | Apr 2019 | CN | national |
Filing Document | Filing Date | Country | Kind |
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PCT/CN2020/083087 | 4/3/2020 | WO | 00 |