Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11173058-B2
Publication Date
2021-11-16
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
A biodegradable or bioabsorbable stent includes an elongated stent body having a proximal end and a distal end, composed of a biodegradable material and having a central guide-wire lumen open at the proximal and distal ends for passage of a guide wire. Two open spiral channels are formed on the exterior surface to provide fluid communication between the proximal end and the distal end.
The central lumen has a circular, oval or elliptical cross-section and is not in fluid communication with the open spiral channels. The two open spiral channels have a rotation rate of at least 1.5 twists per inch, and the spiral channels can provide proximal-to-distal fluid communication while maintaining separation from the central guide-wire lumen.
The document also describes embodiments and characteristics for clinical use of such a stent, including anti-migration devices and biological or therapeutic agent incorporation. It describes an in situ expandable stent behavior with an increase from a pre-implantation diameter D_pre to a larger post-implantation diameter D_post due to absorption of a body fluid, with D_post greater than D_pre, along with radio-opacity, degradation profiles, and delivery concepts using a pusher or guide-wire assembly.
Claims Coverage
The partial content provides one independent claim and several dependent refinements. The independent claim includes three main inventive structures or requirements: a biodegradable stent with two open spiral channels providing proximal-to-distal fluid communication, a central guide-wire lumen with a specified cross-section that is not in fluid communication with the spiral channels, and a required minimum spiral-channel rotation rate of at least 1.5 twists per inch.
Biodegradable stent with two exterior open spiral channels for proximal-to-distal fluid communication
An elongated body composed of biodegradable material having a proximal end and a distal end, with two open spiral channels formed on an exterior surface to provide fluid communication between the proximal end and the distal end.
Central guide-wire lumen with circular, oval or elliptical cross-section not in fluid communication with spiral channels
A central lumen open at the proximal and distal ends for passage of a guide wire, wherein the central lumen has a circular, oval or elliptical cross-section and is not in fluid communication with the open spiral channels.
Spiral channels having rotation rate of at least 1.5 twists per inch
Two open spiral channels having a rotation rate of at least 1.5 twists per inch.
Method of emplacing the biodegradable stent using guide-wire advancement and withdrawal
A method comprising establishing an entry portal into a vessel, duct or lumen contiguous with a target site, advancing a guide wire through the entry portal to the target site, advancing the stent along the guide wire to the target site, and withdrawing the guide wire.
Spiral-channel rotation rate range refinement
Two open spiral channels whose rotation rate is between about 1.5 and 2.5 twists per inch.
Higher spiral-channel rotation threshold refinement
Two open spiral channels with a rotation rate of at least about 2 twists per inch.
Opposite-side placement of the two open channels
Two open channels positioned on opposite sides of the stent’s exterior surface.
In situ diameter expansion via absorption with D_post greater than D_pre
Diameter expansion in situ after implantation due to absorption of a body fluid, increasing from a pre-implantation diameter D_pre to a larger post-implantation diameter D_post, with D_post greater than D_pre.
Biological agent selection for incorporation
A biological agent chosen from chemotherapeutic agents, antimicrobial agents, or gene transfer agents.
Across the independent and dependent claim refinements provided, coverage centers on a biodegradable elongated stent having two open spiral channels that provide proximal-to-distal fluid communication, while a central guide-wire lumen (circular, oval or elliptical) remains not in fluid communication with those spiral channels; the spiral channels require a rotation rate of at least 1.5 twists per inch, with dependent refinements further specifying tighter rotation ranges and thresholds, channel placement on opposite sides, in situ diameter expansion behavior (D_post > D_pre), and selectable classes of biological agents.
Stated Advantages
Improved flow rates versus control stents.
Improved resistance metrics versus control stents, including migration resistance and crush resistance.
Generally acceptable safety and efficacy outcomes.
Documented Applications
Biliary and pancreatic strictures treated using endoscopic delivery, with an example delivery context including ERCP/endoscopic delivery.
A human study described as involving 24 patients.
An animal study described using a porcine common bile duct.
Interested in licensing this patent?