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Publication Number
US-11464657-B2
Publication Date
2022-10-11
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. A polymer element is coiled to form first, second, and third pluralities of central lobes arranged longitudinally along a stent axis from a first end to a second end, with at least one peripheral lobe disposed on each of the central lobes in the furled state.
The polymer element rotates in a first rotational direction to form the first plurality of central lobes, rotates in a second rotational direction to form the second plurality of central lobes, and again rotates in the first rotational direction to form the third plurality of central lobes. The second plurality and the third plurality form an opposing winding pattern to the first plurality along the stent axis, and the terminal ends of the polymer element are positioned in a middle section.
The expanded state behavior is described such that peripheral lobes plasticize and create rigid regions for structural integrity and elastic recoil. Optional features include longitudinal support rods secured to central lobes, radio-opacity using radio-opaque materials, and drug loading with extended release options using biodegradable polymers such as PDLA and related biodegradable polymers.
Claims Coverage
Two independent claims define a polymer-coiled stent with furled small-diameter and expanded large-diameter states, opposing winding patterns, and terminal ends located in a middle section. The inventive features are refined by dependencies addressing peripheral-lobe arrangement, polymer fiber/material types, and loading with radio-opaque and/or drug materials.
Opposing winding polymer-lobe architecture with furled and expanded states
A stent having a furled, small-diameter state and an expanded, large-diameter state, including a polymer element coiled to form first, second, and third pluralities of central lobes arranged longitudinally along a stent axis, where at least one peripheral lobe is on each of the first, second, and third pluralities, and where the second plurality and the third plurality form an opposing winding pattern to the first plurality along the stent axis.
Terminal ends located in the middle section
A stent according to the furled-state architecture in which the terminal ends of the polymer element are in the middle section.
Central-lobe rotation in first and second rotational directions
A stent in which the polymer element rotates in a first rotational direction to form the first plurality of central lobes and the polymer element rotates in a second rotational direction to form the second plurality of central lobes, with additional rotation in the first rotational direction to form the third plurality, and each plurality forms longitudinal spacing as the polymer element moves from the first end to the second end, from the middle section to the first end, and from the second end to the middle section, respectively.
Terminal-end positioning without opposing pattern (second independent claim form)
A stent having a furled, small-diameter state and an expanded, large-diameter state, with a polymer element coiled to form first, second, and third pluralities of central lobes with at least one peripheral lobe on each of the first, second, and third pluralities, where the second and third pluralities form an opposing winding pattern to the first along the stent axis, and where the terminal ends of the polymer element are in the middle section.
Across both independent claims, the core claimed concept is a polymer element coiled into multiple longitudinally arranged central lobes with peripheral lobes, where opposing winding patterns are formed by rotation in first and second rotational directions and the terminal ends of the polymer element are located in a middle section.
Stated Advantages
Alleviating failure of welds during balloon expansion in larger-diameter stents.
Creating rigid regions for structural integrity and elastic recoil via plasticization of peripheral lobes (PLLA).
Documented Applications
Stent deployment by balloon catheter, including expansion to a larger-diameter stent and resulting mechanical behavior of peripheral lobes during balloon expansion.
Imaging/visualization use via optional radio-opacity using radio-opaque materials (e.g., barium sulfate, water-soluble iodine, platinum).
Drug-eluting use by loading the polymer fiber with materials including curcumin, niacin, anti-inflammatory drugs, and anti-proliferative drugs (including extended release options).
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