Ex-vivo Tumor Margin Assessment via MRI Sample Holder

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Solution Overview

Problem

Current methods lack real-time means to assess the margin status of excised breast tumors during surgery, leading to potential incomplete removal of cancerous tissue and subsequent re-operations, as standard pathological evaluation can take days to weeks and is not feasible for breast tissue due to high fat content.

Innovation Solution

A system utilizing an MRI scanner with a sample holder that allows for intra-operative margin assessment by evaluating the surface of the excised lump, providing real-time feedback to surgeons on the presence of cancerous tissue, thereby reducing re-operation rates without replacing definitive pathological evaluation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If standard pathological evaluation is used to assess margin status, then accurate detection of cancerous tissue is achieved, but the evaluation time is extended to days or weeks

Engineering Contradiction:
Improvemargin status detection accuracyVSAvoidevaluation time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent applies preliminary action by performing margin assessment during the surgical procedure itself rather than after. The MRI scanner is brought into the operating room to evaluate the excised tissue immediately, allowing the surgeon to make real-time decisions about whether additional tissue needs to be removed, thereby eliminating the days or weeks delay associated with standard pathological evaluation.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces MRI imaging as an intermediary method between surgical excision and final pathological evaluation. This intermediary technique provides rapid feedback on margin status without replacing the definitive pathological assessment, bridging the time gap between surgery and final diagnosis.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of time

If frozen sections are used for rapid margin assessment, then evaluation time is reduced, but the method cannot be applied to breast tissue due to high fat content

Engineering Contradiction:
Improveevaluation timeVSAvoidapplicability to breast tissue
Core Design Contradiction:
Loss of timeVSAdaptability or versatility

Solution Approach 1:

The patent replaces the mechanical frozen section technique with MRI imaging for margin assessment. MRI does not require freezing or sectioning of the tissue, making it compatible with breast tissue's high fat content while still providing rapid evaluation during surgery.

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

3Measurement precision

If MRI scanning is performed on irregularly shaped excised lumps, then comprehensive margin assessment is achieved, but the scanning complexity and time increase

Engineering Contradiction:
Improvemargin assessment completenessVSAvoidscanning procedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies segmentation by dividing the margin assessment into multiple sequential scans of different faces of the excised lump. The sample holder can be repositioned to scan each face individually, making the complex task of assessing irregularly shaped tissue manageable through systematic segmentation of the scanning process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses the sample holder to position and reposition the excised lump in different orientations and dimensions within the MRI scanner. This allows comprehensive scanning of all faces and margins of irregularly shaped tissue by utilizing multiple spatial dimensions and angles.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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 real-time confirmation of clean margins during lumpectomy procedures, significantly reducing the need for additional surgeries by providing immediate feedback on the completeness of tumor removal, while maintaining the necessity of definitive pathological evaluation for final assessment.

Implementation Method 1

magnetic resonance of nuclei of atoms in the tissue sample

Methodology Applied
Scientific EffectMagnetic resonance: Magnetic Field

Implementation Method 2

detecting electromagnetic radiation emitted by the excited nuclei

Methodology Applied
Scientific EffectElectromagnetic radiation detection: Electromagnetic Induction

Data Source

PatentEP2565663B1Tumor margin assessment of ex-vivo sample
Publication Date: 2016.12.14 CLEAR CUT MEDICAL
  • EP2565663B1 patent drawing
  • EP2565663B1 patent drawing
  • EP2565663B1 patent drawing

AI summary

A system (10) for tumor margin assessment of an ex-vivo tissue (18), comprising an MRI scanner (12) controlled by an imaging control unit (14) and characterised by an ex-vivo sample holder (16) for holding a sample of an excised tissue (18), said sample holder (16) being sized such that excised lump edges (24) of said excised tissue (18) are forced against a surface of said sample holder (16) such that said edges (24) change shape to have a predetermined geometry, and wherein said imaging scanner (12) is positioned relative to said sample holder (16) such that said imaging scanner (12) acquires images not of all the tissue (18) but rather of said edges (24) that have predetermined geometry and which are in a sensitive region (40) extending into a peripheral margin of said tissue (18).