Multi-pleated Balloon for Uniform Polymer Scaffold Expansion

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Solution Overview

Problem

Polymeric scaffolds face challenges in retaining structural integrity during crimping and balloon expansion, with issues of non-uniform deployment, structural failure, and inadequate retention force on delivery balloons, which are not adequately addressed by existing methods.

Innovation Solution

A multi-pleated balloon with 6 to 15 pre-made pleats is used for crimping the polymer scaffold, allowing for increased balloon-scaffold retention and uniform expansion by maintaining pleats in a partially reduced state during crimping, and inflating the balloon after the scaffold has been partially crimped to enhance retention and expansion uniformity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a polymeric scaffold is crimped to a delivery balloon, then the scaffold can be delivered to the target site, but the scaffold may become separated from the balloon during transit due to insufficient retention force

Engineering Contradiction:

Improvescaffold retention on balloonVSAvoidtransit through tortuous anatomy

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The balloon is pre-inflated to a partially expanded state before crimping the scaffold, creating initial retention geometry that prevents scaffold separation during delivery

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The balloon is maintained at elevated temperature during crimping to increase polymer compliance and retention force, then cooled to maintain the crimped configuration during transit

Inventive Principle:

Principle #35Parameter changes

2Length of moving object

If the scaffold is crimped to a small diameter, then it can be delivered through the catheter, but structural failure or excessive cracking occurs during crimping or expansion

Engineering Contradiction:

Improvescaffold diameterVSAvoidstructural integrity

Core Design Contradiction:

Length of moving objectVSStrength

Solution Approach 1:

The scaffold is crimped at elevated temperature where the polymer is more compliant, allowing reduction to small delivery diameter without causing structural failure or excessive cracking

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The balloon is pre-inflated to support the scaffold during crimping, distributing stresses uniformly and preventing localized structural failure

Inventive Principle:

Principle #10Preliminary action

3Reliability

If the scaffold is deployed from the balloon, then it expands to support the lumen, but non-uniform deployment occurs leading to acute or fatigue failure

Engineering Contradiction:

Improvedeployment uniformityVSAvoidfatigue life

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The balloon is divided into multiple pleats that unfold in a controlled sequence, ensuring uniform expansion forces are applied to the scaffold segments

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The balloon is pre-inflated to a partially expanded state during crimping, pre-positioning the pleats to unfold uniformly during deployment

Inventive Principle:

Principle #10Preliminary action

4Strength

If more material is used in the scaffold to increase strength, then it can support lumen walls, but the scaffold becomes heavier and requires thicker struts

Engineering Contradiction:

Improvelumen support capabilityVSAvoidscaffold mass

Core Design Contradiction:

StrengthVSWeight of moving object

Solution Approach 1:

The scaffold material properties are changed by controlling polymer composition and crystallinity, achieving high strength-to-weight ratio without increasing mass or strut thickness

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS9283100B2Polymer scaffold with multi-pleated balloon

Publication Date: 2016.03.15 ABBOTT CARDIOVASCULAR SYSTEMS INC

AI summary

A medical device includes a polymer scaffold crimped to a balloon. The balloon is formed with between 6 and 15 pleats to provide a uniform expansion of the scaffold when the balloon is inflated. Also provided are methods for crimping a scaffold to a multi-pleated balloon and methods for making a multi-pleated balloon.