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

Taewoong Medical Co Ltd

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Publication Number

US-10806612-B2

Patent

Publication Date

2020-10-20

Expiration Date


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 invention relates to a stent using a shape memory alloy wire in which interconnecting is performed by using the shape memory alloy wire and the stent has hooks and cells through direction changing of the wire and hook coupling between the wires. The stent is formed by dividing equator lines (A1 to A14) and dividing dividing lines (B1 to B14) on a circumferential surface of a jig with spacings that form a rhombic geometry. At each intersection of the equator lines and the dividing lines, the stent wire is bent or crossed to continuously repeat a unit cell to form a first stent (10).

The invention further forms a second stent (20) that is vertically overlapped with the first stent by vertically spacing the unit cell downward by an offset pitch (Pv2). As a result, two sides provided at equiangular positions of the overlapped first and second stents are spaced by the offset pitch (Pv2), and a geometrically wide overlapping space (30) is formed by overlapping. This structure uses the same rhombic unit-cell arrangement and the vertical overlap relationship defined by the offset pitch.

A geometrically indexed unit-cell pattern is implemented by connecting intersections while defining horizontal diagonal distance (Ph) and vertical diagonal distance (Pv) as rhombic cell spacings. The invention describes the wire routing as crossings between intersection points in accordance with diagonal distances including L and 2L, and repeating unit-cell interconnection along the longitudinal direction. A first stent is produced by continuously repeating the unit cell, and a second stent is produced with a shifted origin and then overlapped to form the wide overlapping space (30).

Claims Coverage

The document contains one independent claim. The claim covers a shape memory alloy wire stent with rhombic, repeating unit-cell geometry defined by indexed equator/dividing lines, and with a vertically overlapped second stent shifted by an offset pitch to create a geometrically wide overlapping space, where hook coupling and direction changing at wire intersections form cells and connect wires.

Rhombic unit-cell stent defined by indexed equator and dividing lines

A stent having dividing equator lines (A1 to A14) spaced by a horizontal diagonal distance (Ph) and dividing dividing lines (B1 to B14) spaced by a vertical diagonal distance (Pv) and offset pitch (Pv2), where at each intersection of the equator lines and the dividing lines the stent wire is bent or crossed to form a rhombic geometry and a continuously repeated unit cell to form a first stent (10).

Vertically overlapped first and second stents by offset pitch forming wide overlapping space

Vertically spacing the unit cell downward by the offset pitch (Pv2) such that a second stent (20) same as the first stent is overlapped with the same, whereby two sides at equiangular positions are spaced by the offset pitch (Pv2) and a geometrically wide overlapping space (30) is formed by overlapping.

Hooks and hook coupling via direction changing at wire interconnections

A stent using a shape memory alloy wire in which interconnecting is performed by using the shape memory alloy wire and the stent has hooks and cells through direction changing of the wire and hook coupling between the wires.

Across the independent claim coverage, the inventive focus is on an indexed rhombic repeating unit-cell geometry formed by equator/dividing line spacing and wire bending/crossing at intersections, and forming a second stent by vertically overlapping the first stent using an offset pitch to create a geometrically wide overlapping space, together with hook coupling enabled by direction changing of the shape memory alloy wire.

Stated Advantages

Improved fatigue resistance.

Reduced deployment force/profile.

Overlap enables increased stiffness/strength while maintaining conformability.

Multi-axis fatigue testing indicates at least ~2× expansion and ~6× shrinkage fatigue performance versus a conventional stent.

Documented Applications

No documented applications found

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