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Publication Number
US-11596532-B2
Publication Date
2023-03-07
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 relates to a method of making a stent that includes forming an elongated body comprising a biodegradable material, with a proximal end, a distal end, and a central lumen open at the proximal and distal ends for the passage of a guide wire. The elongated body is twisted to form at least one open spiral channel on the exterior surface to provide fluid communication between the proximal end and the distal end. The central lumen is not in fluid communication with the open spiral channels.
The stent geometry is optimized by adjusting a rotation rate of the spiral channels along the stent based on an optimized fluid flow rate between the proximal end and the distal end, and by optimizing flexibility of the stent. The at least one open spiral channel has a rotation rate of at least 1 twist per inch, and dependent refinements specify that the rotation rate may be between about 1.5 and 3.5 twists per inch. The approach maintains the central lumen in a separate function from the exterior open spiral channels while enabling proximal-to-distal fluid communication.
The described implementations further disclose optional structures and manufacturing and characterization features, including forming the elongated body by extrusion, incorporating radio-opaque substances, and providing anti-migration devices. The document also reports shaping stent geometry for a target lumen by recording a target lumen’s shape using optical photography and/or optical videography, and then shaping corresponding zones and connector regions of the stent.
Additional optional stent delivery and deployment are described as expandable/foldable delivery mechanisms, and in situ expansion behavior is addressed via pre- versus post-implantation diameters.
Claims Coverage
One independent claim is provided, centered on a making method that combines biodegradable stent construction, exterior open spiral channels for proximal-to-distal fluid communication, separation from a guide-wire central lumen, and optimization of geometry via spiral-channel rotation rate to achieve both fluid flow and flexibility, with a minimum twist-per-inch limitation.
Biodegradable stent body with separate guide-wire lumen
Form an elongated body comprising a biodegradable material with a proximal end, a distal end, and a central lumen open at the proximal and distal ends for the passage of a guide wire, wherein the central lumen is not in fluid communication with the open spiral channels.
Open spiral exterior channels providing proximal-to-distal fluid communication
Twist the elongated body to form at least one open spiral channel on the exterior surface to provide fluid communication between the proximal end and the distal end.
Geometry optimization via rotation rate of spiral channels for fluid flow and flexibility
Shape the stent’s geometry by optimizing fluid flow rate between the proximal end and the distal end, and optimizing flexibility of the stent, by adjusting a rotation rate of the spiral channels along the stent based on the optimized fluid flow rate.
Minimum spiral rotation rate constraint
Provide that the at least one open spiral channel has a rotation rate of at least 1 twist per inch.
The independent claim(s) cover making a biodegradable stent with an exterior open spiral channel structure that yields proximal-to-distal fluid communication while keeping the guide-wire central lumen not in fluid communication, and defining stent geometry through rotation-rate adjustment of the spiral channels to optimize both fluid flow and flexibility under a minimum twist-per-inch requirement.
Stated Advantages
Increased migration resistance (reported in simulated testing).
Improved crush resistance (reported in simulated testing).
Higher flow rate (reported in simulated testing).
Reduce clogging/migration and avoid repeat extraction procedures (reported as stated intent in the document summary).
Documented Applications
Animal porcine bile duct study for biliary strictures, including feasibility and safety-efficacy study descriptions.
Human clinical study for biliary strictures and pancreatic strictures, including ERCP and related feasibility/safety-efficacy study descriptions.
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