Method for manufacturing stent using shape memory alloy wire, stent manufactured thereby, and jig for manufacturing same
Inventors
Shin, Kyong Min • HONG, Young ill • PARK, Se Ik
Assignees
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Abstract
The present invention relates to a stent that uses a shape memory alloy wire, the stent being an expansion device installed on a part of a body lumen, which is constricted, or which has been constricted, so as to widen the passage of the lumen in response to the lesion part. The purpose of the present invention is to provide a method for manufacturing a stent using a shape memory alloy wire such that the stent maintains a high degree of conformability in a bent portion of a body lumen in which the same is inserted while substantially improving rigidness and durability against continuously applied fatigue, a stent manufactured thereby, and a jig for manufacturing the same.
Core Innovation
The patent relates to manufacturing a stent using a shape memory alloy wire and provides a jig for the manufacturing. The jig includes a body formed in a vertically long cylindrical shape, and the circumference of the body forms a hollow part of the stent to be manufactured. Detachable pins interconnect the wire by being inserted at multiple split positions around the body in X and Y-axis directions to form an interconnected pattern on the jig.
The jig uses equator lines and dividing lines arranged to form a rhombic geometry in a cell grid pattern on the circumferential surface. The equator lines are divided by being spaced by a horizontal diagonal distance (Ph) in the X-axis direction from an arbitrary selected origin, and the equator lines are divided by a horizontal diagonal distance (Ph) at locations apart by a length (Ph1) bisecting the equator line. In a longitudinal direction, the dividing lines are divided by a length (Pv1) bisecting a reference dividing line and by a vertical diagonal distance (Pv) of a cell forming the rhombic geometry.
The interconnected pattern comprises a plurality of first stent loops and a plurality of second stent loops, connected by first connecting portions and second connecting portions, respectively. The first stent loops overlap the second stent loops such that the first connection portions overlap the second connecting portions, and the overlap is configured with an offset pitch (Pv2) by forming dividing lines at locations apart from a reference dividing line.
The patent describes that the manufacturing structure is aimed at improving fatigue resistance and conformability at bent lumen portions by reducing stress concentration at hook placement in the overlapped rhombic-cell structure. It further reports multi-axis stent fatigue test results showing improved expansion and shrinkage fatigue performance compared with a conventional configuration, and it states manufacturability and productivity advantages for the jig and stent manufacturing.
Claims Coverage
The document includes at least one independent claim directed to the jig structure for manufacturing a stent from a shape memory alloy wire, defining the jig geometry and the overlap of first and second stent loops via an offset pitch and overlapping connecting portions. The provided claims identify 3 inventive features.
Vertically long cylindrical jig with pin-interconnected wire at X-Y split positions
A jig for manufacturing a stent using a shape memory alloy wire, the jig comprising a body formed in a vertically long cylindrical shape with a circumference forming a hollow part of a stent to be manufactured, and detachable pins interconnecting the wire by being inserted at multiple split positions around the body in X and Y-axis directions.
Rhombic equator-line and dividing-line grid spacing on the circumferential surface
The jig equator lines are divided by being spaced by a horizontal diagonal distance (Ph) in an X-axis direction from an arbitrary selected origin, and the equator lines are further divided by locations apart by a length (Ph1) bisecting the equator line; in a longitudinal direction, dividing lines are divided by a length (Pv1) bisecting a reference dividing line and by a vertical diagonal distance (Pv) of a cell forming the rhombic geometry.
Overlapped first and second stent loops with overlapping connecting portions via offset pitch (Pv2)
The pins on the jig are inserted into intersections where the first to sixth pattern portions and the first a to sixth a pattern portions are passed to form an interconnected pattern comprising a plurality of first stent loops connected by first connecting portions and a plurality of second stent loops connected by second connecting portions, wherein the first stent loops including the first connection portions overlap the second stent loops including the second connecting portions; and the dividing lines include locations apart by an offset pitch (Pv2) from the reference dividing line.
The core coverage is the jig that uses rhombic equator-line/dividing-line grid spacing to determine pin insertion positions and to form an interconnected pattern of overlapping first and second stent loops, with overlap characterized by an offset pitch (Pv2) and overlapping connecting portions. Dependent refinements further specify offset-pitch double-connection behavior and pitch-length relationships, and include at least one narrowing condition excluding hook coupling between the first and second stent loops.
Stated Advantages
Improved fatigue resistance at bent lumen portions.
Improved conformability at bent lumen portions.
Reduction of stress concentration by dispersing hook placement in the overlapped geometry.
Improved deployment characteristics, including lower deploy force and reduced profile.
Improved multi-axis stent fatigue test performance, reporting at least 2× expansion cycles and at least 6× shrinkage cycles versus a conventional configuration.
Manufacturability/productivity advantages for the jig and stent manufacturing.
Documented Applications
Manufacturing a stent from a shape memory alloy wire using the described jig structure with an overlapped geometry for bent lumen portions.
Use in deployment-related performance evaluation, including multi-axis stent fatigue test performance for expansion and shrinkage fatigue.
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