Method for expansion and deployment of polymeric structures including stents
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-8636787-B2
Publication Date
2014-01-28
Expiration Date
Abstract
The invention is to methods of deploying polymeric biodegradable or non biodegradable stents by use of stepwise creases in the pressure placed upon the inner diameter of the stent to slowly increase the stent diameter. In one embodiment, the pressure on the interior stent diameter is slowly increased. The stent is allowed to acclimate to this diameter for a set period of time, and then the pressure is again increased. This series of steps continues until the stent reaches its final diameter and a final period of acclimatization is maintained prior to the removal of the deployment/delivery device.
Core Innovation
The invention relates to a method for deploying a stent to maintain the mechanical integrity and shape of the stent. The method forms a stent comprising at least one polymer, increases the temperature of the stent to about 37° C for a period of time of at least about 60 seconds, and introduces the stent into the duct or vessel.
The method increases pressure on the interior diameter of the stent and detects stent expansion. After detecting expansion, the method maintains the same pressure on the interior diameter for at least 10 seconds without further expanding the stent, so that the stent acclimates, and repeats the pressure-increase and constant-pressure acclimation steps in a step-wise manner until the stent is at its final desired deployment diameter.
The method maintains the stent temperature below its glass-transition temperature throughout steps (III)-(VI). A further refinement maintains the pressure for at least about 30 seconds once the stent is at its final desired deployment diameter so that the stent acclimates to the final deployment diameter.
Claims Coverage
Independent claim coverage comprises three independent claims that share a common stent-deployment framework, with process timing, detection, step-wise pressure acclimation, and glass-transition temperature control, while one claim restricts the polymer to be biodegradable.
Acclimation during step-wise interior-diameter pressure during deployment
forming a stent comprising at least one polymer; increasing the temperature of the stent to about 37° C for a period of time of at least about 60 seconds; introducing the stent into the duct or vessel; increasing the pressure on the interior diameter of the stent; detecting the stent expansion; maintaining the same pressure on the interior diameter of the stent for at least 10 seconds, without further expanding the stent, so that the stent acclimates; repeating steps (IV) through (VI) until the stent is at its final desired deployment diameter.
Maintaining temperature below glass-transition temperature during deployment steps
the temperature of the stent is maintained below its glass-transition temperature throughout steps (III)-(VI).
Pressure maintained after final desired deployment diameter reached
the pressure is maintained for a period of at least about 30 seconds once the stent is at its final desired deployment diameter so that the stent acclimates to the final deployment diameter.
Polymer is biodegradable
the at least one polymer is biodegradable.
Across the independent claims, the inventive core is maintaining stent mechanical integrity and shape by heating to about 37° C, applying interior-diameter pressure in a step-wise manner with detection and constant-pressure acclimation periods, including an additional acclimation period at the final deployment diameter, and keeping the stent temperature below its glass-transition temperature; one claim further requires the polymer to be biodegradable.
Stated Advantages
Maintain the mechanical integrity and shape of the stent during deployment.
Documented Applications
No documented applications found
Interested in licensing this patent?