Polymer Stent Crimping Temperature Control for Balloon Retention

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Solution Overview

Problem

Polymeric stents face challenges in retaining structural integrity and maintaining mechanical properties during crimping and deployment, with existing methods being unreliable for predicting behavior and prone to fractures, and lacking effective retention on balloons for delivery through tortuous anatomy.

Innovation Solution

A controlled crimping process is employed, heating the polymer stent to a temperature between 48°C and 54°C to enhance retention force on the balloon without causing detrimental effects on mechanical properties, using a heated crimper to deform the stent to a reduced diameter while maintaining its shape and strength.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the polymer stent is crimped at room temperature, then the crimping process is simpler, but the retention force on the balloon is insufficient and the stent may dislodge during delivery

Engineering Contradiction:
Improvecrimping process simplicityVSAvoidstent retention on balloon
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies parameter changes by heating the polymer stent to a specific temperature range (48°C to 54°C) during crimping. This temperature parameter modification increases the polymer's ductility and allows for better retention force on the balloon without causing detrimental effects on mechanical properties after deployment.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the polymer stent is heated to increase retention force, then the stent retains better on the balloon, but the mechanical properties and structural integrity may be compromised

Engineering Contradiction:
Improvestent retention on balloonVSAvoidstent structural integrity
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent precisely controls the heating temperature parameter within a narrow range (48°C to 54°C) to achieve the desired balance. This controlled parameter change provides sufficient retention force while avoiding temperatures that would compromise the polymer's mechanical properties and structural integrity during deployment.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent incorporates feedback mechanisms by monitoring and controlling the heating process to ensure the polymer stent reaches the optimal temperature range without exceeding it. This feedback control prevents overheating that could damage the stent's mechanical properties while ensuring adequate retention force is achieved.

Inventive Principle:
Principle #23Feedback

3Productivity

If conventional crimping methods are used, then the process is faster, but the polymer stent is prone to fractures and cracks

Engineering Contradiction:
Improvecrimping speedVSAvoidstent fracture resistance
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent modifies the temperature parameter during crimping to enhance the polymer's ductility and fracture resistance. By heating to 48°C to 54°C, the material becomes more compliant and less prone to cracking during deformation, while the process is optimized to maintain reasonable productivity.

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 process significantly improves the retention force of the polymer stent on the balloon, reducing the risk of fractures and maintaining the stent's structural integrity during deployment, allowing for effective delivery and deployment within the body lumen.

Implementation Method 1

heating the polymer stent to a temperature between 48°C and 54°C

Methodology Applied
Scientific EffectThermal heating: Heating

Implementation Method 2

plastic deformation of the polymer scaffolding of the stent

Methodology Applied
Scientific EffectPlastic deformation: Plasticity

Data Source

PatentUS9757897B2Methods for crimping a polymeric stent onto a delivery balloon
Publication Date: 2017.09.12 ABBOTT CARDIOVASCULAR SYSTEMS INC
  • US9757897B2 patent drawing
  • US9757897B2 patent drawing
  • US9757897B2 patent drawing

AI summary

A medical device-includes a polymer stent crimped to a catheter having an expansion balloon. The stent is crimped to the balloon by a process that includes heating the stent to a temperature below the polymer's glass transition temperature to improve stent retention without adversely affecting the mechanical characteristics of the stent when later deployed to support a body lumen.