The present disclosure generally relates to the field of minimally invasive medical devices, and in particular, relates to an interventional valve stent and an aortic valve.
In view of problems in prior arts, the purpose of the present disclosure is to provide an interventional valve stent and an aortic valve, which overcomes the problem that the two ends of the valve stent in prior arts are easy to damage the tissue when the valve stent expands. The stress concentration of the oblique rods in the midstream section may be reduced by effectively accepting the stress transmitted by the oblique rods in the midstream section. Thus, the oblique rods in the midstream section may be more likely to expand under stress, to reach the expansion rate of the oblique rods at two ends, thereby reducing or alleviating an adverse effect of the expansion of the two ends of the valve stent to form a dog-bone structure.
Embodiments of the present disclosure provides an interventional valve stent. The interventional valve stent may include a valve stent defining a frame lumen. The valve stent may include straight rods connecting an upstream port and a downstream port, and oblique rods connected between the straight rods. An upstream section, a midstream section, and a downstream section may be sequentially formed along a direction from the upstream port to the downstream port. When the valve stent expands from a compressed state to an expanded state, an expansion strain provided by the oblique rods located in the midstream section to a circumferential direction of the valve stent may be greater than an expansion strain provided by the oblique rods located in the upstream section and/or the downstream section to the circumferential direction of the valve stent to compensate for a rate difference between a rate of circumferential expansion of the midstream section and a rate of circumferential expansion of the upstream section and/or a rate of circumferential expansion of the downstream section.
In some embodiments, during an expansion process of the valve stent, the rate of circumferential expansion of the midstream section may be the same as the rate of circumferential expansion of the upstream section and/or the rate of circumferential expansion of the downstream section.
In some embodiments, the straight rods may be distributed in parallel in a column direction, and the oblique rods may be distributed between the straight rods in multiple rows along a row direction perpendicular to the column direction.
In some embodiments, from a middle of the valve stent to two ends of the valve stent, rod widths of the oblique rods located in different rows may increase sequentially.
In some embodiments, from the middle of the valve stent to the two ends of the valve stent, the rod widths of the oblique rods located in different rows may increase linearly or in stages in an order of rows.
In some embodiments, from a middle of the valve stent to two ends of the valve stent, wall thicknesses of the oblique rods located in different rows may increase sequentially.
In some embodiments, from the middle of the valve stent to the two ends of the valve stent, the wall thicknesses of the oblique rods located in different rows may increase linearly or in stages in an order of rows.
In some embodiments, the oblique rods may be connected in a V-shaped arrangement between two adjacent straight rods to form an included angle between rods. From a middle of the valve stent to two ends of the valve stent, included angles between rods of the oblique rods located in different rows may increase sequentially.
In some embodiments, from the middle of the valve stent to the two ends of the valve stent, the included angles between rods of the oblique rods located in different rows may increase linearly or in stages in an order of rows.
Embodiments of the present disclosure provides an interventional valve stent. The interventional valve stent may include a valve stent defining a frame lumen. The valve stent may include straight rods connecting an upstream port and a downstream port, and oblique rods connected between the straight rods. An upstream section, a midstream section, and a downstream section may be sequentially formed along a direction from the upstream port to the downstream port. When the valve stent expands from a compressed state to an expanded state, an expansion strain provided by the oblique rods located in the midstream section to a circumferential direction of the valve stent may be greater than an expansion strain provided by the oblique rods located in the upstream section and/or the downstream section to the circumferential direction of the valve stent to compensate for a rate difference between a rate of circumferential expansion of the midstream section and a rate of circumferential expansion of the upstream section and/or a rate of circumferential expansion of the downstream section. The straight rods may be distributed in parallel in a column direction, and the oblique rods may be distributed between the straight rods in multiple rows along a row direction perpendicular to the column direction. The oblique rods may be connected in a V-shaped arrangement between two adjacent straight rods to form an included angle between rods. The oblique rods may satisfy a requirement: from a middle of the valve stent to two ends of the valve stent, rod widths, wall thicknesses, and included angles between rods of the oblique rods located in different rows all increase sequentially.
Embodiments of the present disclosure provides an aortic valve. The aortic valve may include an interventional valve stent as described above, and a valve leaflet arranged in a frame lumen formed by the valve stent.
The interventional valve stent and the aortic valve of the present disclosure are conducive to enhancing the internal stress transmission of the oblique rods in the midstream section during the expansion of the valve stent. The stress concentration of the oblique rods in the midstream section may be reduced by effectively accepting the stress transmitted by the oblique rods in the midstream section. Thus, the oblique rods in the midstream section may be more likely to expand under stress, to reach the expansion rate of the oblique rods at two ends, thereby reducing or alleviating the adverse effect of the expansion of the two ends of the valve stent to form a dog-bone structure.
Other features, objectives, and advantages of the present disclosure may become more apparent by reading the detailed description of non-limiting embodiments with reference to the following drawings.
Example embodiments may be described more comprehensively with reference to the accompanying drawings. However, the example embodiments can be implemented in many forms and should not be understood as limited to the embodiments described herein. On the contrary, these embodiments are provided to make the present disclosure comprehensive and complete, and the concept of the example embodiments can be conveyed to those skilled in the art comprehensively. The same reference numerals in the drawings denote the same or similar structures, and thus the repeated descriptions may be omitted.
In some embodiments, the expansion strain provided by the oblique rods 2 to the circumferential direction of the valve stent may refer to an extent to which the oblique rods 2 in different rows in the valve stent expand outward to the circumferential direction of the valve stent after being strained, wherein compared with the oblique rods 2 in the upstream section 10 and the oblique rods 2 in the downstream section 30, the oblique rods 2 in the midstream section 20 may be more likely to expand outward after being stressed, such that, compared with prior arts, the midstream section 20 is easier to bulge out in a S direction (circumferential bulge out at the same time). Subject to the mutual pull and limitation between the oblique rods 2 and the straight rods 1, the sharps at the two ends of the interventional valve stent 100 may no longer open outward, thereby reducing or alleviating the adverse effect of the outward expansion of the two ends of the valve stent to form a dog-bone structure.
In some embodiments, the expansion strain provided by the oblique rods 2 located in the midstream section 20 to the circumferential direction of the valve stent may only be greater than the expansion strain provided by the oblique rods 2 located in the upstream section 10 to the circumferential direction of the valve stent.
In some embodiments, the expansion strain provided by the oblique rods 2 located in the midstream section 20 to the circumferential direction of the valve stent may only be greater than the expansion strain provided by the oblique rods 2 located in the downstream section 30 to the circumferential direction of the valve stent.
In some embodiments, the expansion strain provided by the oblique rods 2 located in the midstream section 20 to the circumferential direction of the valve stent may be greater than the expansion strain provided by the oblique rods 2 located in the upstream section 10 to the circumferential direction of the valve stent, and may also be greater than the expansion strain provided by the oblique rods 2 in the downstream section 30 to the circumferential direction of the valve stent.
In the present disclosure, the oblique rods may satisfy at least one or a combination of two or more of the following conditions.
From a middle of the valve stent to two ends of the valve stent, rod widths of the oblique rods 2 located in different rows may increase sequentially. In some embodiments, the rod width of the oblique rod 2 may be a width dimension (a dimension in a width direction perpendicular to a length direction of the oblique rod 2) of a rectangular area where the oblique rod 2 is exposed on a surface of the frame lumen.
From the middle of the valve stent to the two ends of the valve stent, wall thicknesses of the oblique rods 2 located in different rows may increase sequentially. In some embodiments, the wall thickness of the oblique rod 2 may be a thickness dimension of the oblique rod 2 along a diameter direction of the lumen based on the frame lumen where it is located.
From the middle of the valve stent to the two ends of the valve stent, included angles between rods of the oblique rods located in different rows may increase sequentially. The included angle between rods may be an included angle formed by the two oblique rods 2 arranged in a V shape.
Through the above structures, when the valve stent is expanding, the oblique rods 2 in the midstream section 20 may provide a stronger expansion strain (stronger than the upstream section 10 and/or the downstream section 30) to the circumferential direction of the valve stent to compensate for a rate difference between a rate of circumferential expansion of the midstream section 20, and a rate of circumferential expansion of the upstream section 10 and/or the downstream section 30, such that the rate of circumferential expansion of the midstream section 20 is substantially the same as the rate of circumferential expansion of the upstream section 10 and/or the downstream section 30, but this is not limited. Thus, the diameters of the interventional valve stent in the upstream section 10, the midstream section 20, and the downstream section 30 may be substantially the same, avoiding the situation that the two ends of the expanded valve stent are sharp, avoiding unnecessary damage to the aortic tissue effectively, and preventing the valve stent from loosening or even slipping on the aortic sinus ring.
As shown in
The interventional valve stent 102 in the present embodiment may be mainly supported by the oblique rods and the straight rods in structure. The oblique rods may be the main structural part that control the mechanical properties of the valve stent's compression and expansion. The oblique rods in the same row may have the same width and size. The oblique rods of the aortic valve stent may be divided into five rows according to the principle from top to bottom. The common rod type design may be that the widths of the rods in the five rows are the same. Such design may be relatively simple and direct, and the processing technology may be simple and convenient. However, since the oblique rods in the middle part have straight rods at the two ends to control a state of expansion movement, but the oblique rods at the two ends of the head and tail do not, the situation may lead to the dog bone effect.
As shown in
For example, a change of rod width between rods in adjacent rows may be from 0.01 mm to 0.10 mm, but not limited thereto.
For example, the change of rod width between rods in adjacent rows may be 0.02 mm, but not limited thereto.
For example, the width of the oblique rod in the middle row of the interventional valve stent may be 0.26 mm, from the middle to both two ends of the interventional valve stent, a gradual change of rod width between adjacent oblique rods may be 0.02 mm, and the oblique rods in the rows at the two ends may be 0.29 mm, but not limited thereto.
The present disclosure, the rod widths of the oblique rods at the two ends may be widened, and the increase of the rod widths may cause the current expansion rate of the oblique rods to decrease, so that the expansion rate of the oblique rods at the two ends and the expansion rate of the oblique rods in the middle can be kept consistent, or appropriately slowed down, so as to eliminate or reduce the dog bone effect. During design, it is necessary to keep the gradual change of the rod width, that is, add a margin rod width of 2d at the two ends to an initial rod width, the two ends close to the middle end may be the initial rod width adds the margin rod width of d, and the middle rod width may be the initial design rod width. Thus, the change of rod width is not abrupt and the transition is smooth.
The following table takes the 26 mm aortic valve stent as an example for parallel comparison (comparison between all rod widths are 0.36 mm and a gradual change of rod width is 0.02 mm)
From the comparison results in the above table, it can be seen that the structure of the gradual change of rod width of the interventional valve stent 102 in the present disclosure reduces the deviation between the inflow end and the middle section, and the deviation between the outflow end and the middle section, achieving the effect of reducing the dog bone effect.
A gradual change of included angle between rods may also properly eliminate the dog bone effect. As shown in
For example, from the middle of the valve stent to the two ends of the valve stent, the included angles between rods of the oblique rods 2 in different rows may increase linearly and sequentially in an order of rows, but the present disclosure is not limited thereto.
For example, the included angle between rods of the oblique rods in the middle row of the aortic valve stent may be 120° (an angle range of the included angle between rods of the oblique rods in the middle row may be from 90° to 150°, or from 110° to 130°, or) 120°. From the middle to the two ends, a change of the included angle between rods between adjacent oblique rods may be from 2° to 20° (e.g., from 4° to 10°, or from 6° to) 7°, but not limited to thereto.
The following table is verified by finite element analysis: take the 26 mm aortic valve stent as an example to verify the influence of the gradual change of included angle between rods on the dog bone effect (parallel comparison condition: comparison between all included angles between rods are 120 degrees and the gradual change of included angle between rods, the gradual change of included angle between rods is 7 degrees). The numerical comparison verification:
From the comparison results in the above table, it can be seen that the structure of the gradual change of included angle between rods of the interventional valve stent 103 in the present disclosure reduces the deviation between the inflow end and the middle section, and the deviation between the outflow end and the middle section, achieving the effect of reducing the dog bone effect.
For example, from the middle of the valve stent to the two ends of the valve stent, the wall thicknesses of the oblique rods located in different rows may increase linearly, but not limited thereto.
For example, the wall thicknesses of the oblique rods in the middle row of the interventional valve stent 104 may be 0.47 mm (a range of the wall thickness may be from 0.20 mm to 0.80 mm, e.g., the wall thicknesses may range from 0.47 mm to 0.50 mm), and from the middle to the two ends, a change of the wall thickness of each row may be from 0.01 mm to 0.10 mm (e.g., 0.02 mm), and the initial thickness may be 0.50 mm, but not limited thereto.
Obviously, the interventional valve stent 105 may have the structural features of the three interventional valve stents (the interventional valve stent 102 to the interventional valve stent 104: from the middle to the two ends, the gradual change of the rod width of oblique rods, the gradual change of the included angle between rods of the oblique rods, and the gradual change of the wall thickness of the oblique rods, which is not be repeated here) at the same time, which may effectively enhance the internal stress transmission of the oblique rods in the midstream section. By effectively accepting the stress transmitted from the oblique rods in the midstream section, the stress concentration of the oblique rods in the midstream section may be significantly reduced, so that the oblique rods in the midstream section may be more likely to be expanded under force, and the expansion rate of the oblique rods at both two ends can be achieved, thereby reducing or alleviating the adverse effect of the expansion of the two ends of the valve stent to form a dog-bone structure.
Embodiments of the present disclosure may also provide an aortic valve. The aortic valve may include the above-mentioned interventional valve stent, and a valve leaflet arranged in a frame lumen formed by the valve stent. The aortic valve may have structural features of any of the above-mentioned interventional valve stents, which is conducive to enhancing the internal stress transmission of the oblique rods in the midstream section. By effectively accepting the stress transmitted from the oblique rods in the midstream section, the stress concentration of the oblique rods in the midstream section may be reduced, so that the oblique rods in the midstream section may be more likely to be expanded under force, and the expansion rate of the oblique rods at both two ends can be achieved, thereby reducing or alleviating the adverse effect of the expansion of the two ends of the valve stent to form a dog-bone structure.
To sum up, the purpose of the present disclosure may be to provide an interventional valve stent and an aortic valve, which is conducive to enhancing the internal stress transmission of the oblique rods in the midstream section. By effectively accepting the stress transmitted from the oblique rods in the midstream section, the stress concentration of the oblique rods in the midstream section may be reduced, so that the oblique rods in the midstream section may be more likely to be expanded under force, and the expansion rate of the oblique rods at both two ends can be achieved, thereby reducing or alleviating the adverse effect of the expansion of the two ends of the valve stent to form a dog-bone structure.
The above content is a further detailed description of the present disclosure in combination with specific preferred embodiments, and it cannot be assumed that the specific implementation of the present disclosure is limited to these descriptions. For those of ordinary skill in the technical field of the present disclosure, without departing from the concept of the present disclosure, some simple deduction or replacement can also be made, which should be considered as belonging to the protection scope of the present disclosure.
Number | Date | Country | Kind |
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202010924332.4 | Sep 2020 | CN | national |
This application is a Continuation of International Application No. PCT/CN2021/086495, filed on Apr. 12, 2021, which claims priority to Chinese Patent Application No. 202010924332.4, field on Sep. 4, 2020, the contents of each of which are hereby incorporated by reference.
Number | Date | Country | |
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Parent | PCT/CN2021/086495 | Apr 2021 | US |
Child | 18178454 | US |