Stent and method for manufacturing thereof
Inventors
Assignees
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Publication Number
US-9480586-B2
Publication Date
2016-11-01
Expiration Date
Abstract
According to one aspect of the present disclosure, a method and technique for manufacturing a stent are disclosed. The stent is a non-metallic stent having a furled small-diameter state and an expanded large-diameter state where the stent, in the furled small-diameter state, includes a plurality of central lobes arranged at spaced-apart intervals and extending longitudinally defining a stent axis, the plurality of central lobes defining a cylindrical plane of the stent. The stent also includes at least one peripheral lobe formed on at least one of the plurality of central lobes, the peripheral lobe oriented along the cylindrical plane.
Core Innovation
The invention relates to a non-metallic bifurcated stent having a primary stent component and a secondary stent component, where each component has a furled small-diameter state and an expanded large diameter state. The stent is formed from a polymeric element coiled into spaced-apart central lobes, and the coiled element forms central lobes in a non-parallel winding configuration.
The coiled configuration includes a first plurality of spaced-apart central lobes formed as the element extends from a proximal end to a distal end, and a second plurality of spaced-apart central lobes formed as the element returns from the distal end to the proximal end. At least one peripheral lobe is formed on at least one of the first plurality of central lobes and on at least one of the second plurality of central lobes, and the polymeric element can include support rods attached to the lobes.
For bifurcated operation, the primary stent component has a first portion, a second portion, and a medial portion between the first portion and the second portion. The first and second pluralities of central lobes have substantially uniform axial coil pitch in the first and second portions, while the medial portion has a gap between successive central lobes greater than the axial coil pitch in the first and second portions, and the secondary stent component extends from the gap.
The configuration can be retained and aligned by annealing on a mandrel or coiling tool, and radio-opacity can be provided by loading the polymeric element with radio-opaque material or by providing a radio-opaque sheath and/or radio-opaque attachment.
Claims Coverage
The independent claims describe a bifurcated non-metallic stent with two components and define three main inventive features: dual coiled central-lobe formation, a medial gap that receives the secondary component, and component states from furled small-diameter to expanded large diameter.
Non-metallic bifurcated stent with primary and secondary components
A non-metallic bifurcated stent comprising a primary stent component and a secondary stent component, where each component has a furled small-diameter state and an expanded large diameter state, and each comprises a coiled element forming central lobes and peripheral lobes.
First and second pluralities of non-parallel spaced-apart central lobes
An element forms a first plurality of spaced-apart central lobes as it extends from a proximal end to a distal end, and a second plurality of spaced-apart central lobes as it returns from the distal end to the proximal end, with the first plurality of central lobes formed in a non-parallel winding configuration relative to the second plurality.
Medial portion gap greater than axial coil pitch enabling secondary extension
The primary stent component has first, second, and medial portions, the first and second pluralities of central lobes have substantially uniform axial coil pitch in the first and second portions, and the medial portion has a gap between successive central lobes greater than the axial coil pitch, with the secondary stent component extending from the gap.
Radio-opaque sheath on primary or secondary component
A radio-opaque sheath is applied to at least one of the primary stent component and the secondary stent component.
Longitudinal rods attached to central lobes
At least one longitudinal rod is attached to one or more sides of both the first and second pluralities of central lobes.
Poly-L-Lactic Acid polymer fiber element
The bifurcated stent includes an element made from a Poly-L-Lactic Acid polymer fiber.
Catheter-based insertion of primary and secondary components
Both the primary stent component and the secondary stent component are insertable using a delivery catheter.
The claims center on a non-metallic bifurcated stent with coiled, non-parallel spaced-apart central lobes and a medial gap that receives the secondary component, with dependent refinements including radio-opacity, longitudinal support rods, Poly-L-Lactic Acid polymer fiber, and delivery catheter insertability.
Stated Advantages
Improved delivery/expansion ease and mechanical properties.
Documented Applications
Branch stent/secondary insertion enabled by the bifurcated arrangement of the primary medial gap and extension of the secondary stent component.
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