Stent with Localized Structural Differentiation for Vessel Support

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Solution Overview

Problem

Current stents face challenges such as restenosis, abrupt reclosure, and non-uniform expansion, which can lead to increased trauma and biological responses, particularly in areas like coronary vessels, due to their design and material properties, and there is a need for improved flexibility, visibility, and drug delivery capabilities.

Innovation Solution

A radially expandable stent with a filamental structure featuring arcuate crowns and elongated struts with varying widths and radii, designed for enhanced lateral bending and radial expansion, with strain distribution focused at transition regions, and a method for delivering bioactive agents through a coated substrate for improved tissue interaction and reduced restenosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a stent is designed with uniform structure throughout, then manufacturing is simplified, but it cannot provide different flexibility characteristics needed for different treatment sites

Engineering Contradiction:
Improveflexibility characteristics for different treatment sitesVSAvoidstent structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The stent incorporates different structural characteristics at different locations: the first end portion has a first structural characteristic providing first flexibility, the second end portion has a second structural characteristic providing second flexibility, and the middle portion has a third structural characteristic. This local differentiation allows the stent to adapt to various treatment site requirements while maintaining a relatively simple overall design.

Inventive Principle:
Principle #3Local quality

2Reliability

If a stent has rigid structure to prevent restenosis, then vessel support is improved, but trauma at treatment site increases

Engineering Contradiction:
Improverestenosis preventionVSAvoidtrauma at treatment site
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The stent applies different structural characteristics to different portions: rigid structures in middle portions provide support to prevent restenosis, while more flexible structures at end portions reduce trauma to the treatment site. This localized differentiation allows simultaneous achievement of both reliability and reduced harm.

Inventive Principle:
Principle #3Local quality

3Manufacturing precision

If balloon pressure is increased to achieve uniform stent expansion, then expansion uniformity improves, but trauma at stent ends increases

Engineering Contradiction:
Improvestent expansion uniformityVSAvoidtrauma at stent ends
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The stent's differentiated structural characteristics allow different portions to expand at different rates during balloon inflation. The middle portion with higher radial strength expands later, while end portions with greater flexibility expand earlier, achieving more uniform overall expansion without requiring excessive balloon pressure that would cause end trauma.

Inventive Principle:
Principle #3Local quality

4Object-affected harmful factors

If stent ends are made flexible to reduce trauma, then trauma reduction improves, but expansion uniformity deteriorates

Engineering Contradiction:
Improvetrauma at stent endsVSAvoidexpansion uniformity
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The stent incorporates flexible structures at end portions to reduce trauma while maintaining rigid or semi-rigid structures in middle portions to ensure proper expansion uniformity. This localized structural differentiation allows both objectives to be achieved simultaneously.

Inventive Principle:
Principle #3Local quality

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The stent design provides improved flexibility and uniform expansion, reducing restenosis rates and trauma, while enabling effective drug delivery and enhanced visibility through customized material strain distribution and bioactive agent elution.

Implementation Method 1

The stent undergoes lateral or radial deflection with strain distribution primarily at transition regions between struts and crown shoulders on opposite sides of crown peaks of the stent's filamental pattern

Methodology Applied
Scientific EffectStrain distribution: Deformation

Implementation Method 2

a method for delivering bioactive agents through a coated substrate for improved tissue interaction and reduced restenosis

Methodology Applied
Scientific EffectElution: Diffusion

Data Source

PatentEP3505142B1Implantable and lumen-supporting stents
Publication Date: 2020.10.28 CELONOVA BIOSCIENCES INC
  • EP3505142B1 patent drawingFigure 1A~1B
  • EP3505142B1 patent drawingFigure 1C~1D
  • EP3505142B1 patent drawingFigure 2A~2B

AI summary

An implantable stent includes multiple circumferential segments that surround a bore and are connected in series along a length to form a tubular wall. Multiple adjacent alternating opposite facing crowns arranged along each segment's circumference are bridged by struts. The struts include a series of staggered arcuate edges with limited flats to provide a limited region of maximum width between significantly extended reducing diameter tapers at either end where they transition into the crowns. Connections between adjacent segments are wider and stiffer than the struts and strut-crown transitions in the segments. The crowns include inner and outer radii with off-set centers along a common axis to provide medial crown peaks along the axis that are wider than the narrowed crown shoulders on either side of the axis and from which the tapered struts extend.