Bioabsorbable Stent Degradation Profile Control

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Solution Overview

Problem

Current bioresorbable scaffold projects face challenges in achieving controlled degradation profiles, which is crucial for maintaining mechanical support and ensuring complete absorption without adverse events, limiting their commercialization and effectiveness in vascular treatments.

Innovation Solution

The method involves determining the number average molecular weight (Mn(0)) and monomer content of bioabsorbable polymers using degradation kinetic models to control the degradation time and radial strength loss of stent scaffolding, allowing for tailored degradation profiles that ensure adequate patency and complete absorption within specific time frames.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If bioabsorbable polymer scaffolding is used to provide temporary mechanical support, then the stent can be completely absorbed after serving its function, but the degradation profile is difficult to control precisely

Engineering Contradiction:
Improvedegradation timeVSAvoiddegradation profile control
Core Design Contradiction:
Duration of action of stationary objectVSManufacturing precision

Solution Approach 1:

The patent controls the degradation profile by precisely adjusting polymer parameters including number average molecular weight (Mn), monomer content, and composition. By establishing quantitative relationships between these parameters and degradation characteristics, the invention enables predictable control over degradation time and radial strength loss, resolving the contradiction between complete absorption and controlled degradation profile.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the stent degrades completely to allow absorption, then no long-term complications occur, but the mechanical support is lost before adequate patency is achieved

Engineering Contradiction:
Improvecomplete absorptionVSAvoidpatency duration
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent applies preliminary action by pre-degrading the polymer scaffolding in controlled conditions before implantation. This pre-degradation step allows precise control over the degradation profile, ensuring that the stent maintains mechanical support for the required patency duration while guaranteeing complete absorption afterward, thus resolving the contradiction between reliability and duration.

Inventive Principle:
Principle #10Preliminary action

3Strength

If higher molecular weight polymer is used to maintain radial strength, then mechanical support is improved, but degradation time increases excessively

Engineering Contradiction:
Improveradial strengthVSAvoiddegradation time
Core Design Contradiction:
StrengthVSDuration of action of stationary object

Solution Approach 1:

The patent resolves this contradiction by controlling the number average molecular weight (Mn) within specific ranges and adjusting monomer content to achieve the desired balance. By establishing quantitative relationships between Mn, monomer content, and degradation characteristics, the invention enables optimization of both radial strength and degradation time, preventing excessive degradation time while maintaining adequate mechanical support.

Inventive Principle:
Principle #35Parameter changes

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

This approach enables the development of bioabsorbable stents with controlled degradation profiles, providing sustained mechanical support and ensuring safe, complete absorption, thereby enhancing vascular treatment efficacy and reducing long-term complications.

Implementation Method 1

The stent must be able to satisfy a number of mechanical requirements... degradation kinetic model of the bioabsorbable polymer

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentUS8834776B2Control of degradation profile of bioabsorbable poly(l-lactide) scaffold
Publication Date: 2014.09.16 ABBOTT CARDIOVASCULAR SYSTEMS INC
  • US8834776B2 patent drawing
  • US8834776B2 patent drawing
  • US8834776B2 patent drawing

AI summary

Methods of controlling the degradation profile of a biodegradable stent scaffolding are disclosed. Disclosed methods include controlling features of the degradation profile including the time to loss of radial strength and the degradation time of the stent.