Biodegradable Stent Closed-Cell Strut Design

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Solution Overview

Problem

Current biodegradable shape memory polymer stents face challenges in achieving an optimal combination of mechanical, biochemical, and technological characteristics, leading to issues such as low radial force and suboptimal configuration, which affects their performance and deployment in vascular applications.

Innovation Solution

A biodegradable shape memory stent with a closed-cell structure is developed, featuring a sinusoidal shape and optimized strut configuration, made from a polymer with specific molecular weight and polydispersity index, allowing for improved mechanical properties and mass production suitability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If a biodegradable polymer material is used to create shape memory stents, then the stent can degrade over time and avoid long-term foreign body presence, but the radial force and mechanical strength are reduced compared to metal stents

Engineering Contradiction:
Improvestent degradation timeVSAvoidradial force
Core Design Contradiction:
Duration of action of stationary objectVSStrength

Solution Approach 1:

The patent employs composite polymer structures combining different biodegradable polymer components with complementary properties. The first polymer provides shape memory effect while the second polymer enhances mechanical strength and radial force, creating a synergistic composite material that resolves the contradiction between biodegradability and mechanical performance

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent applies different polymer materials to different regions or layers of the stent structure. By optimizing the local composition and properties of each layer, the stent achieves adequate radial force in critical areas while maintaining overall biodegradability and shape memory functionality

Inventive Principle:
Principle #3Local quality

2Strength

If the stent wall is arranged in a webbed configuration, then the stent can provide structural support, but the operational lumen diameter of the vessel is decreased

Engineering Contradiction:
Improvestructural supportVSAvoidoperational lumen diameter
Core Design Contradiction:
StrengthVSArea of stationary object

Solution Approach 1:

The patent divides the stent wall into discrete, optimized strut segments rather than continuous webbed structures. This segmentation allows blood flow to pass more freely through the stent framework while the strategically positioned segments provide necessary structural support, thus increasing the effective operational lumen diameter

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs curved and sinusoidal strut configurations instead of straight rigid elements. The curved geometry distributes mechanical support more efficiently while creating larger open spaces for blood flow, effectively increasing the operational lumen diameter without compromising structural integrity

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Length of moving object

If the stent is crimped to a small delivery diameter, then the stent can be delivered through catheters, but the ratio of inner diameters before and after crimping affects deployment performance

Engineering Contradiction:
Improvedelivery diameterVSAvoiddeployment performance
Core Design Contradiction:
Length of moving objectVSReliability

Solution Approach 1:

The patent utilizes the dynamic shape memory properties of the polymer material to enable the stent to transition between crimped and expanded states. The material's viscoelastic behavior and glass transition characteristics allow reversible deformation, enabling reliable deployment from a small delivery diameter to the final expanded configuration without permanent damage

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent controls the crimping and deployment process by manipulating temperature and mechanical stress parameters. By heating the stent above its glass transition temperature during crimping and then allowing it to cool and self-expand, the patent optimizes the diameter ratio and ensures reliable deployment performance while minimizing structural damage

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

The stent achieves a favorable ratio of inner diameters before and after crimping, enhanced radial force, and predictable degradation, ensuring effective vascular support and reduced risk of detachment or migration, while maintaining mechanical properties for an extended period.

Implementation Method 1

biodegradable endovascular shape memory polymer stents

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Polymer

Implementation Method 2

The polymer may be obtained by copolymerization of monomers selected from the following group: L-lactide, D-lactide, D,L-lactide, meso-lactide, glycolide, ε-caprolactone, trimethylene carbonate, p-dioxanone

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentUS11096808B2Biodegradable intravascular shape memory stent
Publication Date: 2021.08.24 RESOTECH MEDICAL SOLUTIONS LLC FZ
  • US11096808B2 patent drawing
  • US11096808B2 patent drawing
  • US11096808B2 patent drawing

AI summary

Biodegradable self-expanding polymer stent has an outer diameter of 0.25-40 mm, length of 5-250 mm, and closed-cell wall structure formed by struts, where ratio of inner diameter values before crimping and after crimping is in a range of 3 to 5, and made of a copolymer obtained from L-lactide, D-lactide, D,L-lactide, meso-lactide, glycolide, ε-caprolactone, trimethylene carbonate, p-dioxanone and compounds comprising functional groups capable of photopolymerization; supramolecular structure of the copolymer is oriented substantially circularly in a transversal cross section of the stent. Method of manufacturing includes extruding a tube of a polymer material; annealing the extruded polymer tube; laser cutting the extruded polymer tube to form a stent workpiece; heating the stent to above glass transition temperature of the polymer, crimping the stent workpiece uniformly over the entire outer surface thereof, and quenching at about minus 20 degrees Celsius; placing the quenched stent on a delivery means.