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Publication Number
US-11224528-B2
Publication Date
2022-01-18
Expiration Date
Abstract
A stent is disclosed that has an elongated body having a proximal end, a distal end, at least one open spiral channel 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 stent for placement in a subject, including an elongated body having a proximal end and a distal end. At least one exterior open spiral channel is formed on the exterior surface of the body to provide fluid communication between the proximal end and the distal end, and the stent includes a central lumen open at the proximal and distal ends for the passage of a guide wire.
In embodiments, the at least one open spiral channel has a rotation rate between about 1.5 and 3.5 twists per inch, and in some claims between about 1.5 and 2.5 twists per inch. The description further includes optional more than one open spiral channel, exterior spiral channels integrally formed on the exterior surface of an elongated body, and a central lumen having a circular cross-section.
The stent and placement method are described in relation to in situ expansion based on absorption of body fluid, including expansion from a pre-implantation diameter (Dpre) to a post-implantation diameter (Dpost). The description further identifies stent constructions using bioabsorbable polymers, and biological agents may be included, including chemotherapeutic agents, antimicrobial agents, and gene transfer agents.
A method of emplacing the stent is described by establishing an entry portal into a vessel, duct or lumen contiguous with a target site, advancing a guide wire to the target site, advancing the stent along the guide wire, and withdrawing the guide wire.
Claims Coverage
The independent claim covers a method of emplacing a stent with an elongated body, exterior open spiral channel(s) providing proximal-to-distal fluid communication, and a central guide-wire lumen, with a quantitative spiral rotation rate between about 1.5 and 3.5 twists per inch. The claim also requires establishing an entry portal, advancing a guide wire to a target site, advancing the stent along the guide wire, and withdrawing the guide wire.
Portal-to-target stent emplacement with guide-wire advancement
A method of emplacing a stent in a subject by establishing an entry portal into a vessel, duct or lumen contiguous with a target site, advancing a guide wire through the entry portal and to the target site, advancing the stent along the guide wire to the target site, and withdrawing the guide wire.
Exterior open spiral channel for proximal-to-distal fluid communication
A stent having an elongated body with a proximal end and a distal end, and at least one open spiral channel formed on the exterior surface to provide fluid communication between the proximal end and the distal end.
Rotation rate bounded exterior spiral channel
The at least one open spiral channel has a rotation rate of between about 1.5 and 3.5 twists per inch.
Central guide-wire lumen open at proximal and distal ends
A central lumen open at the proximal and distal ends of the stent for the passage of a guide wire.
In situ expansion by absorption of body fluid
The stent expands in situ after implantation by absorbing body fluid, increasing its diameter from a pre-implantation diameter (Dpre) to a larger post-implantation diameter (Dpost).
Biological agent included on the stent
The stent includes a biological agent.
Biological agent selected from specified categories
The biological agent is selected from chemotherapeutic agents, antimicrobial agents, or gene transfer agents.
Tighter spiral rotation rate range
The at least one open spiral channel has a rotation rate between about 1.5 and 2.5 twists per inch.
Exterior spiral channels and central lumen geometry
Open spiral channels are integrally formed on the exterior surface of an elongated body, with a central lumen having a circular cross-section.
Overall, the claim set is directed to a guide-wire based stent emplacement method using an elongated stent with exterior open spiral channel(s) that provide proximal-to-distal fluid communication under a specified twists-per-inch rotation rate, plus a central lumen for guide-wire passage. Dependent features further restrict rotation rate, add biological agent categories, and define in situ expansion from Dpre to Dpost via absorption of body fluid, alongside specific structural geometry refinements.
Stated Advantages
Reduced migration and reduced clogging are described as functional/clinical advantages of the stent.
Optimized flow is described using twists-per-inch control of the open spiral channel rotation rate.
Reduced need for sequential exchanges is described for biodegradable stents.
Documented Applications
Treatment of duct stricture is described, including pancreatic/biliary duct stricture via ERCP.
A kit for stent placement is described including the stent, a guide wire, and optionally a pushing catheter/sheath/cannula/sphincterotome/radio-opaque dye.
An ERCP example flow is described in the document.
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