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Publication Number
US-12004978-B2
Publication Date
2024-06-11
Expiration Date
Abstract
A dual opposing helical stent having a furled, small-diameter state and an expanded, large-diameter state. In the furled, small-diameter state, the stent includes a plurality of central lobes arranged at spaced-apart intervals and extending longitudinally defining a stent axis. The stent also includes peripheral lobes formed on the plurality of central lobes. The terminal ends of the stent are welded in a middle section of the stent. A method and technique for manufacturing the stent is also disclosed.
Core Innovation
The invention relates to a stent having a furled, small-diameter state and an expanded, large-diameter state. The stent includes a polymer element coiled to form a first plurality of central lobes arranged longitudinally along a stent axis from a first end to a second end, together with a second plurality of central lobes and a third plurality of central lobes extending from a middle section of the stent to the opposite ends.
At least one peripheral lobe is provided on each of the first plurality of central lobes, the second plurality of central lobes, and the third plurality of central lobes. The second plurality of central lobes and the third plurality of central lobes form an opposing winding pattern to the first plurality of central lobes along the stent axis, and in another configuration the first plurality of central lobes and the third plurality of central lobes form an opposing winding pattern to the second plurality of central lobes along the stent axis.
A method for forming the stent includes winding the polymer element to create the furled, small-diameter state and the expanded, large-diameter state. The method includes winding central lobes in a first rotational direction and winding a reserve portion in a second rotational direction such that central lobes have an opposing winding pattern and at least one peripheral lobe is wound in each central lobe during winding.
The polymer element includes biodegradable polymer fibers, and the loaded polymer fiber can include radio-opaque material and/or a drug or therapeutic agent, including curcumin and niacin as well as anti-inflammatory and anti-proliferative materials. The polymer arrangement supports mechanical integrity in the furled and expanded states, while the radio-opaque loading supports visibility and the drug loading supports therapeutic delivery.
Claims Coverage
The document includes three independent claims covering a polymer-based stent and methods for forming the stent. Across these claims, the inventive subject matter includes three longitudinal central-lobe pluralities, at least one peripheral lobe on each central lobe, terminal ends positioned in the middle section, and an opposing winding pattern along the stent axis.
Winding polymer element into longitudinally spaced central lobes with opposing winding pattern
Forming a stent in a furled, small-diameter state includes winding a polymer element to form a first plurality of central lobes arranged longitudinally along a stent axis from a first stent end to a second stent end, and winding to form second and third pluralities such that the second plurality of central lobes and the third plurality of central lobes form an opposing winding pattern to the first plurality of central lobes along the stent axis.
Terminal ends positioned in the middle section
The polymer element is wound so that a first terminal end and a second terminal end are located in the middle section of the stent.
Peripheral lobes wound on each central lobe
During winding of the first plurality of central lobes, the second plurality of central lobes, and the third plurality of central lobes, at least one peripheral lobe is wound in each of the central lobes.
Stent structure with three pluralities of longitudinal central lobes
A stent having a furled, small-diameter state and an expanded, large-diameter state is provided, the stent comprising a polymer element coiled to form a first plurality of central lobes arranged longitudinally along a stent axis from a first end to a second end, together with a second plurality of central lobes extending from a middle section of the stent to the first end and a third plurality extending from the middle section of the stent to the second end.
Method using opposing winding pattern from middle section and terminal ends in middle section
Forming a stent includes winding a polymer element in a first rotational direction to form a first plurality of central lobes from a middle section to a first stent end, winding to form a second plurality from the first stent end to a second stent end, and winding to form a third plurality from the second stent end to the middle section, wherein the terminal ends are in the middle section and the first and third pluralities form an opposing winding pattern to the second plurality along the stent axis.
Collectively, the independent claims define a polymer-based stent movable between furled small-diameter and expanded large-diameter states, a coiled polymer element forming three longitudinally arranged central-lobe pluralities, at least one peripheral lobe associated with each central lobe during formation, terminal ends located in the middle section, and an opposing winding pattern between central-lobe pluralities along the stent axis.
Stated Advantages
Mechanical integrity in the furled and expanded states.
Radio-opaque loading supports visibility.
Drug loading supports therapeutic delivery.
Documented Applications
Not explicitly described in patent.
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