Stent and method for manufacturing thereof

Inventors

Welch, Tre' Raymond

Assignees

Tremedics Medical Devices Inc

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Publication Number

US-9943423-B2

Patent

Publication Date

2018-04-17

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 stent configured to have a furled small-diameter state and an expanded large diameter state. In the furled small-diameter state, the stent includes a first plurality of central lobes arranged at spaced apart intervals and extending longitudinally defining a stent axis, and a second plurality of central lobes arranged at spaced apart intervals and extending longitudinally along the stent axis. The first plurality of central lobes and the second plurality of central lobes define a cylindrical surface of the stent.

The stent further includes at least one peripheral lobe formed on at least one of the first plurality of central lobes and on at least one of the second plurality of central lobes, where the at least one peripheral lobe is oriented within the cylindrical surface and extends longitudinally along the stent axis. The lobes of the first plurality, the second plurality, and the at least one peripheral lobe are formed by a coiled rotation of an element. As the element is rotated in a rotational winding direction, the first plurality of central lobes are formed in a first longitudinal direction along the stent axis and the second plurality of central lobes are formed in a second longitudinal direction along the stent axis.

The opposing winding pattern forms respective first and second helices along the stent axis, and the stent includes dual opposing helical winding forming first and second sets of central lobes with opposing longitudinal directions, and additional coiling forming peripheral lobes extending radially inward within a cylindrical plane. The stent may include longitudinal support rods attached to the lobes and may include a bifurcated medial portion for branch-stent attachment.

Radio-opaque material may be incorporated in the polymer or used as an attached film or sheath for fluoroscopic identification or x-ray visibility. The manufacture may be described as being formed on a mandrel with annealing to retain polymer shape and orientation, supporting flexible delivery and expansion with good mechanical properties and plastic deformation.

Claims Coverage

The document provides coverage centered on one independent claim, with dependent claims refining structural and payload features. The independent claim defines the stent geometry and the opposing helical coiled-rotation formation that yields both a furled small-diameter state and an expanded large-diameter state.

Opposing-helical non-metallic stent with furled and expanded states

A non-metallic stent having a furled small-diameter state and an expanded large diameter state, including first and second pluralities of central lobes defining a cylindrical surface of the stent and at least one peripheral lobe oriented within the cylindrical surface, where the lobes are formed by a coiled rotation of an element that forms respective first and second helices with an opposing winding pattern along the stent axis.

Radio-opaque chemical agent loaded element

The stent includes an element loaded with a chemical agent, where the chemical agent is a radio-opaque agent.

Longitudinal support rods attached to lobes

The stent includes at least one longitudinal rod attached to the first plurality of central lobes and the second plurality of central lobes.

Overall claim coverage focuses on a non-metallic stent formed by coiled rotation to produce opposing helices of central lobes along the stent axis, a peripheral lobe oriented within the cylindrical surface, and dependent refinements adding a radio-opaque chemical-agent payload or longitudinal support rods attached to the lobes.

Stated Advantages

Flexible delivery and expansion.

Good mechanical properties and plastic deformation.

Documented Applications

Branch-stent attachment using a bifurcated medial portion.

Fluoroscopic identification and x-ray visibility via radio-opaque materials.

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