Retrofitted Mammography System for 3D Specimen Imaging

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Solution Overview

Problem

Current methods for evaluating positive margins during breast lumpectomy surgery, such as 2D specimen evaluation and histopathology, are inadequate for confident detection, leading to high re-excision rates and delays, as they do not provide sufficient 3D information in a timely manner.

Innovation Solution

An intraoperative specimen imaging system is developed by retrofitting a mammography imaging system with a specimen holding system that rotates the tissue sample up to 360 degrees, enabling the acquisition of 3D images using existing mammography imaging systems, which can be used in the operating room to assess margins during surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If 2D specimen evaluation is performed using commercial imaging system, then imaging can be performed in operating room, but insufficient 3D information is provided for confident margin detection

Engineering Contradiction:
Improve3D informationVSAvoidimaging system complexity
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The patent applies dimensionality change by transitioning from 2D mammography imaging to 3D tomographic imaging of lumpectomy specimens. The system acquires multiple 2D projection images at different angles and reconstructs them into 3D volumetric data, enabling comprehensive margin assessment in three dimensions while maintaining compatibility with existing mammography infrastructure.

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

Solution Approach 2:

The patent makes existing mammography imaging systems multi-functional by enabling them to perform both traditional breast imaging and specimen imaging capabilities. Through software modifications and optional rotational mechanisms, the same hardware platform serves dual purposes, reducing the need for separate specialized equipment.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If specimen is sent to radiology department for imaging, then adequate imaging capability is available, but delay and scheduling issues are introduced

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

Solution Approach 1:

The patent enables preliminary action by allowing specimen imaging to be performed immediately in the operating room during the surgical procedure itself. The specimen can be imaged before leaving the surgical suite, providing real-time feedback for margin assessment and eliminating the need for post-operative scheduling delays.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The operating room becomes self-sufficient for specimen imaging needs through the integrated system. The mammography imaging system, when modified with specimen imaging capabilities and rotational mechanisms, allows the surgical team to perform comprehensive 3D margin assessment independently without requiring external radiology department resources.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If histopathology is used for margin evaluation, then gold standard accuracy is achieved, but more than a day delay occurs before results

Engineering Contradiction:
Improvemargin evaluation accuracyVSAvoidresults availability time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent creates a radiographic copy or surrogate representation of the specimen's internal structure through 3D tomographic reconstruction. While not replacing histopathological analysis entirely, the 3D imaging provides a detailed radiographic model that can identify suspicious areas requiring targeted pathological examination, potentially reducing the need for extensive routine processing delays.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent applies partial action by using 3D imaging to assess margins in high-risk areas or when positive margins are suspected, rather than requiring full histopathological processing for all cases. This selective approach maintains gold standard accuracy for critical decisions while reducing unnecessary processing time for clearly negative margins.

Inventive Principle:
Principle #16Partial or excessive action

4Adaptability or versatility

If existing mammography system is retrofitted with specimen holding system, then 3D imaging capability is enabled, but device complexity increases

Engineering Contradiction:
Improveimaging system versatilityVSAvoidsystem configuration complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent applies nesting by placing the specimen holder and rotational mechanism within the existing mammography system framework. The specimen imaging capabilities are nested within the established hardware architecture, utilizing the existing X-ray tube, detector, and control systems while adding only the necessary rotational and positioning components.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent merges specimen imaging functionality with the existing mammography system by integrating software controls and hardware components. The rotational mechanism, specimen holder, and imaging software are combined into a unified system that operates through the existing control interface, minimizing the need for separate complex subsystems.

Inventive Principle:
Principle #5Merging (Combining)

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 solution provides high-resolution 3D images that can confidently detect or rule out positive margins, potentially reducing re-excision rates to zero by enabling accurate margin assessment during surgery, thus improving surgical outcomes and reducing costs.

Implementation Method 1

emitting radiation from a radiation source of the mammography imaging system to acquire imaging data of the tissue sample at the different angular positions

Methodology Applied
Scientific EffectX-Ray: X-Ray

Data Source

PatentUS11692951B2System and method for specimen imaging using an existing mammography imaging system
Publication Date: 2023.07.04 GE PRECISION HEALTHCARE LLC
  • US11692951B2 patent drawing
  • US11692951B2 patent drawing
  • US11692951B2 patent drawing

AI summary

An intraoperative specimen imaging system is provided. The intraoperative specimen imaging system includes a mammography imaging system configured to acquire imaging data. The intraoperative specimen imaging system also includes a specimen holding system configured to hold a tissue sample, wherein the specimen holding system is retrofittedly coupled to the mammography imaging system, wherein the intraoperative specimen imaging system is configured to acquire imaging data for generating three-dimensional (3D) images of the tissue sample.