Medical Balloon with Embedded Filar Elements for Burst Resistance

Solution Overview

Problem

Current balloon catheters face issues with circumferential bursting during medical procedures, leading to fragments of the balloon being difficult to recover, as existing solutions like thickening the material or adding strengthening elements compromise flexibility and expandability.

Innovation Solution

Incorporating longitudinal filar elements made of strong, flexible materials like Kevlar or Dyneema into the balloon wall to prevent circumferential tear propagation, ensuring the balloon remains attached to the catheter in case of a burst, without affecting radial expansion or flexibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the thickness of the balloon wall material is increased to prevent circumferential burst, then the strength and reliability of the balloon is improved, but the flexibility and compressibility of the balloon deteriorates, leading to an increased balloon and introducer profile

Engineering Contradiction:

Improveresistance to circumferential burstVSAvoidballoon profile and flexibility

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The balloon wall is constructed as a composite structure combining a thin polymer membrane with embedded filar elements (such as braided or mesh reinforcement). This composite construction provides the strength and burst resistance of thick material while maintaining the flexibility and low profile of thin material, as the filar elements are distributed throughout the wall thickness rather than requiring uniform thickening.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The reinforcement is applied locally where needed - the filar elements are embedded within the balloon wall material at strategic positions to provide circumferential strength without requiring the entire balloon wall to be uniformly thickened. This allows the balloon to maintain flexibility in non-critical areas while having enhanced burst resistance where the filar elements are positioned.

Inventive Principle:

Principle #3Local quality

2Reliability

If strengthening elements such as braiding or meshes are added to the balloon structure to reduce the chance of balloon burst, then the reliability of the balloon is improved, but the device complexity and balloon profile increase

Engineering Contradiction:

Improveresistance to circumferential burstVSAvoidballoon structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The strengthening filar elements are merged with the balloon wall material itself, forming an integrated composite structure rather than adding separate external layers. The filar elements are embedded within the polymer matrix, combining the structural reinforcement function with the balloon wall material into a single unified component, reducing overall device complexity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The balloon wall is constructed as a composite structure combining a thin polymer membrane with embedded filar elements (such as braided or mesh reinforcement). This composite construction provides the strength and burst resistance of thick material while maintaining the flexibility and low profile of thin material, as the filar elements are distributed throughout the wall thickness rather than requiring uniform thickening.

Inventive Principle:

Principle #40Composite materials

3Strength

If the balloon wall is thickened to prevent circumferential tear propagation, then the strength and reliability of the balloon is improved, but the radial expandability and flexibility of the balloon deteriorates

Engineering Contradiction:

Improveresistance to circumferential tear propagationVSAvoidradial expandability and flexibility

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

The balloon wall is constructed as a composite structure combining a thin polymer membrane with embedded filar elements (such as braided or mesh reinforcement). This composite construction provides the strength and burst resistance of thick material while maintaining the flexibility and low profile of thin material, as the filar elements are distributed throughout the wall thickness rather than requiring uniform thickening.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The reinforcement is achieved through discrete filar elements distributed throughout the balloon wall rather than a continuous thick layer. These segmented reinforcement elements provide tear propagation resistance while allowing the surrounding thin polymer material to maintain flexibility and radial expandability.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS11040177B2Medical balloon with incorporated fibers

Publication Date: 2021.06.22 COOK MEDICAL TECHNOLOGIES LLC

AI summary

A balloon catheter assembly comprises a balloon having attached to or in its wall one or more filar elements, extending from one end of the balloon to the other. The filar elements are made of a material which is at least as flexible as the material forming the walls of the balloon. In the event of circular burst of the balloon, the filar element(s) prevent disconnection of the material of the balloon into two or more separate pieces. The filar element(s) become attached to or in the material of the balloon wall when the raw material is inflated to the shape of a mold. The filar elements may comprise a natural fiber, a synthetic fiber or a metal wire.