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Publication Number
US-11207199-B2
Publication Date
2021-12-28
Expiration Date
Abstract
A stent is disclosed that has an elongated body composed of a bioabsorbable polymer having a proximal end, a distal end, two open spiral channels formed on the exterior surface of the body to provide fluid communication between the proximal end and the distal end. The stent has a central lumen open at the proximal and distal ends of the stent for the passage of a guide wire. The stent also has an anti-migration device used for immobilization of the stent at the target site.
Core Innovation
The invention describes a stent comprising an elongated body of biodegradable material with a proximal end and a distal end. The exterior surface includes at least one open spiral channel formed to provide fluid communication between the proximal end and the distal end, and the central lumen is open at the proximal and distal ends for passage of a guide wire.
The central lumen has an oval or elliptical cross-section and is not in fluid communication with the exterior open spiral channel. The stent includes at least two anti-migration tails extending beyond at least one end of the elongated body in a longitudinal direction, and the at least two anti-migration tails extending from the at least one end form a Y-shape with the elongated body.
The anti-migration tails are blunt-shaped at their ends. The configuration combines fluid communication through the open spiral channel with independent guide-wire passage through the central lumen, while using the Y-shaped anti-migration tails to resist migration and maintain positioning.
Claims Coverage
The independent claim requires a biodegradable polymer stent architecture with separated fluid communication and guide-wire passage, plus a specific Y-shaped anti-migration tail arrangement with blunt-shaped ends. The inventive features are implemented through one independent claim with multiple dependent refinements focusing on tail geometry and configuration.
Separated open spiral channel and central guide-wire lumen
An elongated body composed of a biodegradable material having a proximal end and a distal end; at least one open spiral channel formed on the exterior surface to provide fluid communication between the proximal end and the distal end; and a central lumen open at the proximal and distal ends for passage of a guide wire, wherein the central lumen comprises an oval or elliptical cross-section and is not in fluid communication with the at least one open spiral channel.
Y-shaped anti-migration tails extending beyond an end
The stent comprises at least two anti-migration tails extending beyond at least one end of the elongated body in a longitudinal direction, wherein the at least two anti-migration tails extending from at least one end of the elongated body form a Y-shape with the elongated body.
Blunt-shaped tail ends
The anti-migration tails are blunt-shaped at their ends.
Overall, the claim coverage centers on a biodegradable stent with exterior open spiral channels for fluid communication that are structurally separated from an oval/elliptical central guide-wire lumen, combined with at least two Y-shaped anti-migration tails extending beyond an end and having blunt-shaped ends. Dependent claims further refine tail geometry and tailoring.
Stated Advantages
Improved flow and migration resistance compared with simulated and reported testing outcomes.
Good deliverability/trackability/visibility.
Acceptable safety, including histopathology findings reported in the document.
Documented Applications
Use as a stent in biliary/pancreatic ducts, including example use in an ERCP procedure described in the document.
Animal studies reported using a porcine model, and a human clinical study reported with 24 patients.
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