Plasticized Nylon Balloon Material for Angioplasty

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Solution Overview

Problem

Medical balloons used in angioplasty procedures require a balance between high strength for burst resistance and flexibility for navigation through tortuous vessels, but existing high-strength polymers like nylons are often stiff and lack the desired flexibility and trackability, and the addition of plasticizers to enhance flexibility can compromise biocompatibility.

Innovation Solution

Development of a plasticized nylon material using an amide-containing plasticizer, specifically compounds with defined structural formulas, combined with Nylon-12, to enhance flexibility and trackability while maintaining high strength, which includes compounding the nylon with the plasticizer using techniques like extrusion and ensuring compatibility with E-beam sterilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If high-strength polymers like nylons are used for burst resistance, then strength is improved, but flexibility and trackability deteriorate

Engineering Contradiction:
Improveburst strengthVSAvoidflexibility and trackability
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The patent changes the chemical composition parameters of the nylon polymer by incorporating specific plasticizer molecules (such as N-butylbenzenesulfonamide and related compounds) into the nylon matrix. This chemical parameter modification reduces the glass transition temperature and increases chain mobility, thereby improving flexibility and trackability while preserving the high tensile strength needed for burst resistance in angioplasty balloons.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite material system combining nylon polymer with specially designed plasticizer molecules. The plasticizer acts as a molecular lubricant between polymer chains, creating a composite structure that maintains the structural integrity and strength of nylon while adding flexibility through the plasticizer's molecular structure. This composite approach resolves the contradiction between strength and flexibility.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If plasticizer is added to enhance flexibility, then flexibility is improved, but biocompatibility deteriorates

Engineering Contradiction:
ImproveflexibilityVSAvoidbiocompatibility
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by designing plasticizer molecules with specific functional groups (sulfonamide, carboxylic acid, hydroxyl) that provide localized biocompatible interactions at the polymer-plasticizer interface and at the device-tissue interface. The plasticizer molecules are strategically structured to maintain flexibility in the bulk material while presenting biocompatible surfaces when in contact with biological tissues, thus resolving the contradiction between flexibility enhancement and biocompatibility maintenance.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS10729817B2Medical device and plasticized nylon
Publication Date: 2020.08.04 MEDTRONIC VASCULAR INC
  • US10729817B2 patent drawing
  • US10729817B2 patent drawing
  • US10729817B2 patent drawing

AI summary

A medical device, such as a dilatation balloon, including plasticized nylon, and plasticized nylon.