Radiopaque Marker with Deformable Gap for Vascular Stent Positioning

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Solution Overview

Problem

Current vascular devices, such as stents, face challenges in accurate positioning and tracking due to the complexity of treating vascular disorders near critical tissues, especially in cranial areas where access is restricted, leading to difficulties in confirming correct placement during procedures.

Innovation Solution

A radiopaque marker system is introduced, featuring an elongated body made of biocompatible materials like platinum alloy or tantalum, which can be securely attached to stent struts using a mechanism that allows for unobstructed insertion and subsequent securement, enhancing visibility under imaging techniques and preventing unintended removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Difficulty of detecting and measuring

If a radiopaque marker is attached to a stent strut, then visibility under imaging techniques is improved, but the device complexity increases

Engineering Contradiction:
Improvevisibility under imagingVSAvoiddevice complexity
Core Design Contradiction:
Difficulty of detecting and measuringVSDevice complexity

Solution Approach 1:

The marker body is formed as a single integrated piece with the gap feature built-in, combining the marker function with the attachment mechanism in one component rather than using separate parts

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The marker body is made from a flexible or malleable radiopaque material that can be deformed to close the gap, allowing the marker to transition from an open state during insertion to a closed state for secure attachment

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If the marker body is deformed to close the gap, then the marker is securely attached to the strut, but the manufacturing precision requirements increase

Engineering Contradiction:
Improvemarker attachment securityVSAvoidgap closure precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The marker body transitions from a static open configuration during insertion to a dynamic closed configuration after attachment, allowing the structure to adapt its state based on the operational phase

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The physical state of the marker body changes through deformation, altering the gap dimension from open to closed, which secures the marker to the strut while maintaining manufacturing feasibility

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If the gap remains open for strut insertion, then the ease of operation is improved, but the reliability of marker retention decreases

Engineering Contradiction:
Improvestrut insertion easeVSAvoidmarker retention
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The marker structure dynamically transitions from an open state that allows easy strut insertion to a closed state that provides reliable retention, with the gap serving as a temporary feature only during the insertion phase

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The gap is pre-formed in the marker body to facilitate strut insertion before the marker is deployed, and subsequent deformation closes the gap to secure the marker in place

Inventive Principle:
Principle #10Preliminary action

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

The radiopaque marker system provides reliable and quick placement of highly visible markers on vascular devices, improving locatability and reducing the risk of misplacement during vascular procedures, especially in sensitive areas like the brain.

Implementation Method 1

an elongated body formed of a biocompatible radiopaque material that enhances locating the marker when using at least one imaging technique

Methodology Applied
Scientific EffectRadiopacity: Absorption (EM radiation)

Data Source

PatentEP3701915B1Improved radiopaque marker for vascular devices
Publication Date: 2023.06.07 DEPUY SYNTHES PROD INC
  • EP3701915B1 patent drawingFigure 1~3
  • EP3701915B1 patent drawingFigure 4~7
  • EP3701915B1 patent drawingFigure 8~9

AI summary

A marker to assist locating a device such as an expandable stent within vasculature of a patient, including an elongated body formed of a biocompatible radiopaque material that enhances locating the marker when using at least one imaging technique. The body has a first end, a second end, an inner surface, an outer surface, and at least two opposing edges extending between the first and second ends and establishing a boundary between the inner surface and the outer surface. The inner surface of the body defines a passageway extending between the first and second ends. In a first condition, the body defines a gap between the at least two opposing edges, the gap enabling unobstructed communication of the passageway with the outer surface of the body. In a second condition, the gap is obstructed to substantially prevent communication of the passageway with the outer surface of the body.