Balloon Implant Placement Using Visual Markers Without Fluoroscopy

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Solution Overview

Problem

Implantation of implantable medical devices (IMDs) is challenging due to the difficulty in determining the position of an inflatable balloon relative to an introducer without using fluoroscopic imaging, which can be harmful to patients.

Innovation Solution

The use of visual markers on the implantable medical device, such as zone visual markers, rotation visual markers, and radiopaque markers, allows clinicians to determine the position and alignment of the balloon relative to the introducer without fluoroscopy, ensuring safe and consistent implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopic imaging is used to determine balloon position relative to introducer, then measurement precision is improved, but patient exposure to harmful radiation increases

Engineering Contradiction:

Improveballoon position determinationVSAvoidpatient radiation exposure

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

Visual markers are introduced as intermediary elements that enable indirect observation of balloon position. The markers serve as mediators between the balloon-introducer system and the clinician's visual assessment, allowing position determination without direct fluoroscopic imaging of the balloon itself.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the fluoroscopic imaging system (electromagnetic/radiation-based) with a visual marker system (optical/mechanical). This substitution eliminates radiation exposure while maintaining the ability to determine balloon position through visual alignment of markers with the introducer.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If visual markers are used to determine balloon position, then patient safety is improved by eliminating radiation, but ease of operation may be worsened due to limited visual visibility

Engineering Contradiction:

Improvepatient radiation exposureVSAvoidvisual assessment difficulty

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The visual markers are designed with specific color properties to enhance visibility. By utilizing color contrast and optical characteristics, the markers become more easily distinguishable during the implantation procedure, improving ease of visual assessment while maintaining radiation-free operation.

Inventive Principle:

Principle #32Color changes

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 method enhances patient safety by eliminating the need for harmful fluoroscopic imaging and improves the success rate of IMD implantation procedures.

Implementation Method 1

a balloon mechanically supported by the device body

Methodology Applied

Scientific EffectInflation:

Data Source

PatentUS20260021292A1System for placement of a medical device including an inflatable balloon

Publication Date: 2026.01.22 MEDTRONIC INC

AI summary

An implant tool system includes an implantable medical device. The implantable medical device includes a zone visual marker positioned on an exterior surface of the device. The zone visual marker includes a distal end of the zone visual marker. The distal end of the zone visual marker aligning with the proximal end of an introducer indicates when to withdraw the introducer. The zone visual marker further includes a proximal end of the zone visual marker. The proximal end of the zone visual marker aligning with the proximal end of the introducer indicates when to inflate a balloon carried by the device and affix the distal end of the implantable medical device to the target site via a fixation mechanism.