Point-of-use calibration system for iron ion detection

Solution Overview

Problem

Current minimally invasive spinal procedures lack objective, reliable, and real-time feedback for detecting critical tissues and bodily fluids, leading to risks of iatrogenic injuries due to operator dependence and anatomical variability, with no existing device providing consistent verification of needle placement in critical anatomic structures.

Innovation Solution

A calibration verification system using a multi-chambered vial with distinct ionic solutions and an ion-detection needle connected to a feedback system, allowing for point-of-use calibration to verify the accuracy of the needle by differentiating between low and high iron ion concentrations, providing real-time feedback through indicators and displays.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If operator-dependent methods (tactile feel, contrast agents, anatomical landmark palpation) are used for detecting critical tissues, then practitioner experience and training can improve detection accuracy, but iatrogenic injury can still occur independently of practitioner experience due to anatomic variability

Engineering Contradiction:

Improvedetection accuracyVSAvoidconsistency of detection

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent replaces operator-dependent mechanical detection methods (tactile feel, palpation) with an automated ion detection system that uses a needle equipped with an ion detector to objectively detect ions in bodily fluids. This substitution eliminates reliance on practitioner experience while providing consistent, reliable detection across different operators and anatomical variations.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system incorporates real-time feedback through an ion detector that provides immediate objective information about needle placement and proximity to critical structures. This feedback loop allows the operator to adjust needle position based on quantitative ion concentration data, improving both detection accuracy and reliability regardless of practitioner experience level.

Inventive Principle:

Principle #23Feedback

2Measurement precision

If additional training and experience are provided to practitioners, then detection capability may improve, but outcomes from the procedure can still vary considerably due to anatomic variability

Engineering Contradiction:

Improvedetection capabilityVSAvoidhandling of anatomic variability

Core Design Contradiction:

Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent replaces operator-dependent mechanical detection methods (tactile feel, palpation) with an automated ion detection system that uses a needle equipped with an ion detector to objectively detect ions in bodily fluids. This substitution eliminates reliance on practitioner experience while providing consistent, reliable detection across different operators and anatomical variations.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system adapts to anatomic variability by monitoring changes in ion concentration parameters in real-time. As the needle encounters different tissues and fluids with varying ion compositions, the detector provides quantitative data that allows the operator to identify critical structures regardless of their location or the patient's unique anatomy.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If no objective verification device is used, then device complexity is reduced, but the safety and reliability of needle placement cannot be ensured

Engineering Contradiction:

Improveverification of needle placementVSAvoidsystem complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces operator-dependent mechanical detection methods (tactile feel, palpation) with an automated ion detection system that uses a needle equipped with an ion detector to objectively detect ions in bodily fluids. This substitution eliminates reliance on practitioner experience while providing consistent, reliable detection across different operators and anatomical variations.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The needle system performs self-verification by incorporating an ion detector directly into the needle structure. The needle automatically detects and reports ion concentrations as it is advanced, providing self-contained verification of needle placement without requiring separate verification devices or complex external systems.

Inventive Principle:

Principle #25Self-service

4Measurement precision

If a calibration system with multiple chambers and ionic solutions is implemented, then point-of-use calibration accuracy is improved, but device complexity increases

Engineering Contradiction:

Improvecalibration accuracyVSAvoidcalibration system structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple calibration chambers containing different ionic solutions into a single integrated calibration device. This merged structure allows sequential access to multiple calibration standards through a single needle insertion, providing comprehensive calibration without requiring multiple separate devices or complex setup procedures.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The calibration system is segmented into multiple chambers, each containing a specific ionic solution with known concentration. This segmentation allows the system to provide multiple calibration points and standards within a single device, enabling comprehensive calibration verification while maintaining a manageable and portable structure.

Inventive Principle:

Principle #1Segmentation

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 provides objective, reliable, and real-time feedback, reducing the risk of iatrogenic injuries by ensuring accurate needle placement and minimizing operator dependence, thereby enhancing the safety and effectiveness of minimally invasive spinal procedures.

Implementation Method 1

an ion detector is disposed on the distal end... providing real-time feedback through indicators and displays

Methodology Applied

Scientific EffectIon detection:

Data Source

PatentUS20240237929A1Point-of-use calibration system for iron ion detection system

Publication Date: 2024.07.18 ACIES MEDICAL LLC

AI summary

A point-of-care ion calibration system that may utilize acquis solutions that contain different concentrations of ions. In some instances, the system utilizes a multi-chambered device wherein each separate chamber may contain a different concentration of ions. These concentrations may calibrate an ion detector which may be disposed within the end of a needle. The ion detector may pass into each chamber to obtain an ion level that may be feedback to an end-user. If the end-user cannot differentiate the feedback from varying ion concentrations, then the detector may not be working correctly and may be discarded.