Radiopaque Markings on Medical Balloon Working Surface

Solution Overview

Problem

Current medical balloons used for angioplasty face challenges in precise location identification during procedures, misalignment issues due to tolerance stack-ups and balloon expansion, and prolonged inflation/deflation times, which can lead to geographic misplacement of the working surface and false deflation perceptions.

Innovation Solution

Incorporating strategically positioned radiopaque markings on the balloon surface to enhance locatability and visibility under fluoroscopy, allowing for accurate positioning of the working surface without increasing the balloon's diameter or complexity, and using these markings to differentiate between inflated and deflated states.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Difficulty of detecting and measuring

If radiopaque markings are added to the balloon surface, then visibility and locatability of the working surface is improved, but device complexity increases

Engineering Contradiction:

Core Design Contradiction:

Difficulty of detecting and measuringVSDevice complexity

Solution Approach 1:

The patent applies radiopaque markings (analogous to color changes in visual detection) on the balloon surface to enhance visibility under fluoroscopy. These markings create radiopaque patterns that are easily detectable during the procedure, allowing physicians to accurately locate the working surface without adding complex mechanical or electronic components to the balloon structure.

Inventive Principle:

Principle #32Color changes

2Measurement precision

If marker bands are attached to the catheter shaft, then the position of the working surface can be located, but misalignment occurs due to tolerance stack-ups and balloon expansion

Engineering Contradiction:

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The radiopaque markings are pre-positioned directly on the balloon surface at locations that correspond to the working surface boundaries in both deflated and inflated states. This preliminary positioning ensures that regardless of balloon expansion or catheter flexing, the markings remain accurately aligned with the working surface, eliminating the misalignment problems associated with shaft-mounted markers.

Inventive Principle:

Principle #10Preliminary action

3Difficulty of detecting and measuring

If contrast agent is used to inflate the balloon, then visibility under X-ray is improved, but inflation and deflation times are prolonged

Engineering Contradiction:

Core Design Contradiction:

Difficulty of detecting and measuringVSLoss of time

Solution Approach 1:

The patent extracts the visibility function from the inflation medium (contradicting the conventional approach of using contrast agent as both inflation fluid and visibility provider). Instead, the visibility function is provided by radiopaque markings on the balloon surface, which remain visible regardless of the inflation medium used. This allows the use of non-contrast agents like saline or carbon dioxide for inflation, significantly reducing inflation and deflation times while maintaining visibility.

Inventive Principle:

Principle #2Taking out (Extraction)

4Difficulty of detecting and measuring

If contrast agent is used for balloon inflation, then radiographic visibility is enhanced, but the risk of iodine exposure to sensitive patients increases

Engineering Contradiction:

Core Design Contradiction:

Difficulty of detecting and measuringVSObject-affected harmful factors

Solution Approach 1:

The radiopaque markings serve as an intermediary that provides radiographic visibility without requiring the use of contrast agents containing iodine. These markings are made from radiopaque materials such as barium sulfate or tungsten, which provide the necessary X-ray visibility while being safe for patients with iodine sensitivity, thus mediating between the need for visibility and the need to avoid harmful substances.

Inventive Principle:

Principle #24Intermediary (Mediator)

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

Enables precise identification and accurate positioning of the balloon's working surface, reducing procedural inefficiencies and the risk of misplacement, while maintaining the balloon's profile and reducing the need for contrast agents.

Implementation Method 1

at least one radiopaque identifier for indicating a location of the working surface... having a first radiographic quality for identifying the location of the first end of the working surface and a second radiographic quality at a location other than at the first end of the working surface

Methodology Applied

Scientific EffectX-ray absorption: Absorption (EM radiation)

Data Source

PatentUS11771873B2Medical balloon with radiopaque identifier for precisely identifying the working surface

Publication Date: 2023.10.03

AI summary

A balloon (12) having a drug carried on a working surface (W) of the balloon wall and a radiopaque identifier (30) identifying the location of the drug (D) on the balloon (12), wherein a portion of the balloon is coated with a radiopaque material to which a drug formulation adheres, and uncoated areas are not covered by the drug (D) or the drug (D) is adhered to the working surface (W), that is not treated with radiopaque material.