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Publication Number
US-12343269-B2
Publication Date
2025-07-01
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 also has a central lumen open at the proximal and distal ends of the stent for the passage of a guide wire. A method for using the stent and a kit containing the stent are also disclosed.
Core Innovation
The invention is a stent that includes an elongated body with a proximal end and a distal end. The stent has an open spiral channel formed on the exterior surface of the body to provide fluid communication between the proximal end and the distal end, and the elongated body further includes a tapered tip at the proximal end to facilitate advancement of the stent inside a body lumen and a wide distal flare at the distal end to prevent migration and increase stability of the stent.
The stent also includes a central lumen that is open at the proximal and distal ends for the passage of a guide wire. The central lumen is not in fluid communication with the open spiral channel, separating guide-wire passage from the spiral-channel fluid communication. The description further associates the exterior open spiral/helical channels with proximal-to-distal fluid communication and specifies channel rotation rate ranges including at least about 1 twist per inch and ranges including about 1.5–2.5 or about 1.5–3.5 twists per inch.
The described stent arrangement can include anti-migration devices and radio-opacity, and is applied to biliary strictures and pancreatic strictures. A stent emplacement method is described using an entry portal, guide wire advancement, stent advancement along the guide wire to a target site, and withdrawing the guide wire. A placement kit is also described as including the stent and a guide wire together with components such as a pushing catheter, introducer sheath/tube, cannula, sphincterotome, and a radio-opaque substance for visibility.
Claims Coverage
The independent claim set comprises four independent claim families identified by the provided claim IDs (clm-00001 through clm-00005). Across these, the inventive features are centered on an exterior open spiral channel providing proximal-to-distal fluid communication, a separate central guide-wire lumen not in fluid communication with the spiral channel, and structural features to facilitate advancement and improve stability and migration resistance, with dependent refinements regarding rotation rate and additional claims directed to placement method and placement kit.
Exterior open spiral channel providing proximal-to-distal fluid communication
An open spiral channel formed on the exterior surface of the elongated body to provide fluid communication between the proximal end and the distal end.
Proximal tapered tip to facilitate advancement
A tapered tip at the proximal end to facilitate advancement of the stent inside a body lumen.
Wide distal flare to prevent migration and increase stability
A wide distal flare at the distal end that prevents migration and increases stability of the stent.
Separate central guide-wire lumen not in fluid communication
A central lumen open at the proximal and distal ends of the stent for the passage of a guide wire, wherein the central lumen is not in fluid communication with the open spiral channel.
Rotation rate constraint for the spiral channel
A rotation rate constraint for the open spiral channel, including at least about 1.5–2.5 twists per inch or at least about 2 twists per inch (as specified in the dependent refinements).
Entry portal and guide-wire based stent emplacement sequence
A method for placing a stent in a subject including creating an entry portal to a contiguous vessel/duct/lumen, advancing a guide wire to a target site, advancing the stent along the guide wire to the target site, and withdrawing the guide wire.
Placement kit including the stent and a guide wire
A kit for stent placement that includes the stent and a guide wire.
Overall, the claims focus on a stent with an exterior open spiral channel for proximal-to-distal fluid communication combined with a separate central guide-wire lumen that is not in fluid communication with the spiral channel, supported by a proximal tapered tip and a wide distal flare for advancement and stability. Dependent refinements further constrain the spiral-channel rotation rate, while separate claims cover a guide-wire based stent emplacement method and a placement kit comprising the stent and guide wire.
Stated Advantages
Prevents migration and increases stability of the stent.
Facilitates advancement of the stent inside a body lumen.
Documented Applications
Biliary strictures.
Pancreatic strictures.
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