Stent and method for manufacturing thereof

Inventors

Welch, Tre′ Raymond

Assignees

Tremedics Medical Devices Inc

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Publication Number

US-9155640-B2

Patent

Publication Date

2015-10-13

Expiration Date


Abstract

According to one aspect of the present disclosure, a method and technique for manufacturing a stent is 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 having 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, where the first plurality of central lobes extends in a coiled manner from a proximal end of the stent to a distal end of the stent. A second plurality of central lobes is arranged at spaced apart intervals and extends longitudinally in the direction of the stent axis, extending from the distal end to the proximal end in a coiled manner.

The coiled rotation is configured to create opposing rotational winding directions along the stent axis. In one configuration, the first plurality of central lobes is formed with a clockwise rotational winding direction from the proximal end to the distal end, and the second plurality of central lobes is formed with a counterclockwise rotational winding direction from the proximal end to the distal end. In another configuration, the first and second pluralities of central lobes are formed in a non-parallel winding configuration relative to each other to form respective first and second helices having an opposing winding pattern along the stent axis.

In both configurations, 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. The at least one peripheral lobe extends radially inward toward an internal area of the stent, and the document further describes optional longitudinal support rods positioned on one or more sides of the central lobes, including configurations where the rod is attached to internal sides.

The document further describes a medial bifurcated or high-axial-pitch portion for branch attachment, variations in coil pitch and lobe spacing, and radio-opacity strategies including radio-opaque material loaded in a polymer, radio-opaque agents for fluoroscopic visibility, and radio-opaque metal or radio-opaque sheathed films.

Claims Coverage

The partial set of independent claims includes three independent claims (clm-00001, clm-00011, clm-00014). Across these claims, the inventive features center on a non-metallic stent that transitions between a furled small-diameter state and an expanded large diameter state using coiled rotational formation of central lobes, with opposing winding patterns between first and second pluralities, and with at least one peripheral lobe formed on the central lobe pluralities.

Opposing coiled central lobes with peripheral lobes

A non-metallic stent having a furled small-diameter state and an expanded large diameter state, comprising first and second pluralities of central lobes arranged at spaced apart intervals and extending longitudinally defining a stent axis, where each lobe of the first plurality of central lobes, the second plurality of central lobes and the at least one peripheral lobe is formed by a coiled rotation of an element, and where the first plurality and the second plurality are formed with clockwise and counterclockwise rotational winding directions, respectively, from proximal end to distal end, with at least one peripheral lobe extending radially inward toward an internal area of the stent.

Non-parallel winding configuration for first and second central lobe pluralities

A non-metallic stent having a furled small-diameter state and an expanded large diameter state, comprising an element forming a first plurality of spaced apart central lobes from a proximal end of the stent to a distal end, each first plurality central lobe formed by a coiled rotation of the element, and a second plurality of spaced apart central lobes formed as the element returns from the distal end to the proximal end, each second plurality central lobe formed by a coiled rotation of the element, wherein the first plurality of central lobes are formed in a non-parallel winding configuration relative to the second plurality of central lobes, and wherein 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.

Opposing-helical winding pattern along the stent axis

A non-metallic stent having a furled small-diameter state and an expanded large diameter state, comprising 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, and 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, wherein each lobe of the first plurality of central lobes, the second plurality of central lobes, and the at least one peripheral lobe is formed by a coiled rotation of an element, and wherein the first plurality of central lobes are formed longitudinally in a first direction along said stent axis in a rotational winding direction and the second plurality of central lobes are formed longitudinally in a second direction along said stent axis in the rotational winding direction to form respective first and second helices having an opposing winding pattern along the stent axis.

Across the independent claims, the coverage centers on coiled-rotation formation of central lobes for a non-metallic transformable stent, with an opposing winding pattern created by clockwise vs counterclockwise winding, a non-parallel winding configuration, or first-and-second helices with opposing winding along the stent axis, together with at least one peripheral lobe formed on the central lobe pluralities.

Stated Advantages

Flexible delivery and expansion.

Mechanical properties with plastic deformation.

Reduces catheter insertion interference by keeping peripheral lobes in the cylindrical plane via annealing.

Documented Applications

Branch attachment using a medial high-axial-pitch (bifurcated) portion.

X-ray/fluoroscopic identification using radio-opacity strategies.

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