Optical Reference Mark for Stent Deployment Positioning

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Solution Overview

Problem

Existing stent insertion systems face challenges in accurately positioning self-expanding stent devices within body vessels due to reliance on X-ray markers, which expose operators and patients to radiation, and require complex and expensive sensor equipment, leading to potential errors and vessel trauma during deployment.

Innovation Solution

An insertion system with optical and physical reference marks that allow continuous visual monitoring of the stent device's axial position without additional detection equipment, ensuring precise placement and reducing the need for X-ray monitoring and complex sensors, thereby simplifying the deployment process and minimizing vessel trauma.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If X-ray markers are used to monitor stent device position during deployment, then measurement precision is improved, but object-affected harmful factors increase due to radiation exposure

Engineering Contradiction:
Improveposition monitoring precisionVSAvoidradiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the X-ray based monitoring system with an optical reference mark system. The optical reference mark is positioned on the insertion system at a known location relative to the stent device, allowing visual monitoring of stent position without radiation exposure. This substitutes the mechanical/X-ray detection system with a simple optical visualization system.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent creates a visual copy or representation of the stent device position through the optical reference mark. The reference mark serves as a visual indicator that replicates the positional information of the stent device relative to the vessel, allowing operators to monitor deployment without direct X-ray imaging.

Inventive Principle:
Principle #26Copying

2Measurement precision

If complex sensor equipment is used to detect stent device position, then measurement precision is improved, but device complexity increases

Engineering Contradiction:
Improveposition detection precisionVSAvoidsensor equipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex sensor equipment with a simple optical reference mark system. The reference mark provides visual positional information without requiring electronic sensors, signal processing systems, or complex detection equipment, thereby maintaining measurement precision while dramatically reducing device complexity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The optical reference mark is a simple, inexpensive visual indicator that can be integrated into the single-use insertion system. It provides the necessary positional information without the cost and complexity of expensive, sensitive sensor technologies.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Shape

If the sheath is retracted to deploy the stent device, then the stent device expands to its functional shape, but the axial position of the stent device may shift relative to the landing zone

Engineering Contradiction:
Improvestent device expansionVSAvoidaxial position accuracy
Core Design Contradiction:
ShapeVSManufacturing precision

Solution Approach 1:

The patent implements visual feedback through the optical reference mark positioned on the insertion system. During sheath retraction and stent deployment, the operator can continuously monitor the position of the reference mark relative to anatomical landmarks or other reference points, providing real-time feedback to maintain accurate axial positioning while the stent expands.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The optical reference mark is pre-positioned on the insertion system at a known location relative to the stent device and deployment zone before the procedure begins. This preliminary positioning establishes a visual reference framework that guides the operator throughout the deployment process, ensuring accurate axial positioning is maintained from the start.

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 system enables safe and accurate placement of stent devices by providing a visual aid for operators to maintain the stent's position relative to the landing zone, reducing the risk of misplacement and vessel damage, and eliminating the need for costly and sensitive sensor technologies.

Implementation Method 1

the stent device, by virtue of the resiliency of the metal frame or metal stent, expands back to its original shape in the portion of the stent device released from the sheath

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP2165683B1Insertion system for deployment of catheter-based stent devices
Publication Date: 2013.11.13 JOTEC
  • EP2165683B1 patent drawingFigure 1
  • EP2165683B1 patent drawingFigure 2
  • EP2165683B1 patent drawingFigure 3

AI summary

An insertion system for release of a self-expanding stent device (18) in a body vessel comprises a first grip (33), which is fixedly connected to a shaft (15), a second grip (36), which is mounted on the shaft (15) to be movable in axial direction, a sheath (19), which, in a distal portion thereof, keeps the stent device radially compressed and which is fixedly connected to the second grip (36), and a retention element (17), which is fixedly connected to the shaft (15) and is guided in the sheath (19), wherein the retention element (17) holds the stent device (18) in its axial position relative to the first grip (33) when the sheath (19) is being retracted. Reference means (25) with an optical reference mark (26) are provided for continuous monitoring of the axial position of the stent device (18). (Fig. 6)