Medical device suitable for location in a body lumen
Inventors
Heraty, Kevin • Mullins, Liam • Gilson, Paul • Burke, Martin G.
Assignees
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Publication Number
US-10966847-B2
Publication Date
2021-04-06
Expiration Date
Abstract
A medical device suitable for location in a body lumen is movable between a first loaded configuration and a second loaded configuration. The device has an unloaded configuration which is intermediate the first loaded configuration and the second loaded configuration. The device can be a stent for deployment in a blood vessel.
Core Innovation
The invention relates to a method of employing a medical device in a body lumen, wherein the medical device is a stent. The stent is deployed and expanded in the body lumen so that the body lumen is deformable between an unloaded state and a loaded state, where in the loaded state the body lumen is more curved than in the unloaded state. After deployment and expansion, the stent is deformable between a first loaded configuration and a second loaded configuration, and it has an unloaded configuration intermediate the first loaded configuration and the second loaded configuration.
In the unloaded configuration intermediate the first and second loaded configurations, at least part of the longitudinal axis of the stent is helically shaped with an amplitude in which the amplitude of the helical longitudinal axis divided by the diameter of the stent changes across configurations. In the unloaded configuration the amplitude divided by the diameter is in a range of 0.3 to 0.9, and in the second loaded configuration the amplitude divided by the diameter is greater than in the unloaded configuration. In the first loaded configuration at least part of the longitudinal axis is one of straight and helical and the amplitude divided by the diameter is in a range of 0 to 0.5.
The deploying is performed so that after deployment and expansion when the body lumen is in the unloaded state the stent is in the first loaded configuration, and when the body lumen is in the loaded state the stent is in the second loaded configuration. In one aspect, when the stent is axially compressed by 6% from the first loaded configuration to the second loaded configuration, the maximum strain in the stent, at any stage at or between the first and second loaded configurations, is less than or equal to 0.7%.
The described geometries are directed to reducing deformation and strain compared with devices transitioning directly between extreme configurations.
Claims Coverage
Two independent claims are identified: clm-00001 and clm-00014. Across these, there are multiple inventive features centered on maintaining an unloaded intermediate configuration and controlling helical relative amplitude, and in one claim limiting maximum strain under axial compression as the stent transitions between first and second loaded configurations corresponding to unloaded and loaded lumen curvature states.
Deforming a stent between first and second loaded configurations with an intermediate unloaded configuration
A method of employing a stent in a body lumen, where after deployment and expansion the stent is deformable between a first loaded configuration and a second loaded configuration and has an unloaded configuration intermediate the first loaded configuration and the second loaded configuration, with the body lumen deformable between an unloaded state and a loaded state that is more curved in the loaded state.
Helically shaped longitudinal axis with configuration-dependent amplitude relative to stent diameter
In the unloaded and second loaded configurations at least part of the longitudinal axis of the stent is helically shaped, and the amplitude of the helical longitudinal axis divided by the diameter of the stent is greater in the second loaded configuration than in the unloaded configuration, with the unloaded configuration amplitude divided by diameter in the range of 0.3 to 0.9 and the first loaded configuration amplitude divided by diameter in the range of 0 to 0.5.
Deploying so lumen state corresponds to first and second loaded stent configurations
Deploying the stent in the body lumen so that after deployment and expansion when the body lumen is in the unloaded state the stent is in the first loaded configuration, and when the body lumen is in the loaded state the stent is in the second loaded configuration.
Axially compressing between configurations with limited maximum strain
Deploying and expanding the stent and, when the stent is in the deployed, expanded configuration, deforming the stent to a first loaded configuration and deforming the stent to a second loaded configuration, where the stent has an unloaded configuration intermediate the first and second loaded configurations and, when the stent is axially compressed by 6% from the first loaded configuration to the second loaded configuration, the maximum strain in the stent, at any stage at or between the first and second loaded configurations, is less than or equal to 0.7%.
The independent claims cover a stent-deployment method where an intermediate unloaded configuration is maintained during deformation between a first loaded configuration and a second loaded configuration linked to a lumen that becomes more curved when loaded. The claims additionally constrain the relative helical amplitude of the longitudinal axis across unloaded, first loaded, and second loaded configurations, and one claim further limits maximum strain under a specified axial compression from the first to the second loaded configuration.
Stated Advantages
Reduced deformation and strain compared with devices that transition directly between extreme configurations.
Documented Applications
No documented applications found
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