Catheter Balloon Non-Distensible Seals

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Solution Overview

Problem

Balloon catheters face challenges such as length change during inflation, limited large diameter expansion capability, and difficulties in navigating tortuous passageways due to the need for a low profile and sustained pressures, which affect their performance in medical procedures.

Innovation Solution

The development of a wrapped balloon with integrated non-distensible regions, where varying wrap angles create distensible and non-distensible areas, allowing for controlled expansion and sealing, enhancing the balloon's shape and seal strength while maintaining compatibility with the catheter shaft.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the balloon is made of elastomeric material for easy expansion and contraction, then the balloon can be readily pressure-expanded and contracted for removal, but the balloon cannot maintain a non-distensible seal region to prevent length change during inflation

Engineering Contradiction:

Improveballoon expansion and contractionVSAvoidballoon length stability

Core Design Contradiction:

Ease of operationVSStability of the object's composition

Solution Approach 1:

The balloon is segmented into distinct regions: distensible regions made of elastomeric material for expansion/contraction, and non-distensible seal regions with different material properties that maintain length stability. This segmentation allows different parts of the balloon to perform different functions simultaneously.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the balloon are given different local qualities - the seal regions have non-distensible material properties while the body regions have elastomeric properties. This local differentiation enables the balloon to expand radially while maintaining axial length stability at critical seal locations.

Inventive Principle:

Principle #3Local quality

2Ease of operation

If the balloon is designed with low profile for navigating tortuous passageways, then the catheter can be easily inserted and navigated, but the balloon has limited large diameter expansion capability

Engineering Contradiction:

Improvecatheter navigationVSAvoidballoon expansion capability

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The balloon transitions from a compressed, low-profile state during insertion to an expanded, high-capacity state during operation. The non-distensible seal regions provide structural support that enables large diameter expansion while the distensible regions allow dynamic size change for navigation and treatment.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The balloon uses composite construction with non-distensible seal regions providing structural strength and expansion capability, while distensible regions provide flexibility for navigation. This composite approach enables both low profile for insertion and large diameter expansion for treatment.

Inventive Principle:

Principle #40Composite materials

3Strength

If the balloon length changes during inflation, then the balloon can expand to large diameter, but the placement precision and control during procedures deteriorates

Engineering Contradiction:

Improveballoon expansion capabilityVSAvoidballoon placement precision

Core Design Contradiction:

StrengthVSManufacturing precision

Solution Approach 1:

The balloon is divided into non-distensible seal regions that maintain fixed length and distensible body regions that expand radially. This segmentation ensures that expansion occurs in controlled dimensions, maintaining placement precision while achieving large diameter capability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Instead of allowing the entire balloon to expand in all directions, the invention inverts the approach by constraining expansion to radial directions only at distensible regions, while seal regions maintain fixed axial length. This inverted constraint strategy achieves large diameter expansion without length change.

Inventive Principle:

Principle #13The other way round (Inversion)

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

This solution provides improved balloon performance by maintaining shape and seal integrity during inflation, increasing pressure capability, and enabling non-catastrophic failure modes, thus enhancing the effectiveness of balloon catheters in medical procedures.

Implementation Method 1

the wrapped balloon material is configured to expand with essential radial symmetry to a predetermined diameter upon application of a predetermined pressure thereto

Methodology Applied

Scientific EffectPressure expansion: Pressure Increase

Implementation Method 2

integrated non-distensible, or less distensible regions on an inflatable balloon

Methodology Applied

Scientific EffectElastic resistance: Elasticity

Data Source

PatentEP2412399B1Methods of forming catheter balloons with integrated non-distensible seals and corresponding balloons

Publication Date: 2019.10.02 WL GORE & ASSOC INC

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AI summary

A catheter balloon with integral non-distending regions having a plurality of layers which wind around the balloon material and overlap to form an angle of between 45 and 90 degrees relative to each other upon inflation, and methods of making the non-distending regions are provided.