Optical Assay System for Intraoperative Tumor Margin Assessment
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Solution Overview
Problem
Current methods for assessing tumor margins during surgical procedures, such as intraoperative frozen section and touch prep cytology, are limited by the need for specialized personnel, prolonged processing times, and inadequate coverage of tumor margins, leading to high rates of re-excision in breast cancer surgeries.
Innovation Solution
An optical assay system with a biological sample containment and illumination apparatus that uses multiple electromagnetic radiation probes to illuminate and image tumor margins, allowing for rapid and reliable assessment of tissue properties, including the presence of normal and neoplastic cells, through the detection of reflected or emitted radiation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intraoperative frozen section and touch prep cytology are used to assess tumor margins, then the need for re-excision can be reduced, but the surgical time is prolonged (20-40 minutes) and requires specially trained personnel
Solution Approach 1:
The patent replaces the mechanical and chemical processing system of frozen section and touch prep cytology with an optical detection system. The optical assay system uses electromagnetic radiation probes to directly detect tumor cells in tissue sections, eliminating the need for freezing, cutting, and staining processes that consume 20-40 minutes, thereby reducing surgical time while maintaining assessment accuracy
Solution Approach 2:
The patent changes the detection parameter from morphological examination (requiring frozen section and touch prep) to optical property detection (absorption, scattering, fluorescence). This parameter change enables rapid direct detection of tumor cells without time-consuming tissue processing, resolving the contradiction between assessment reliability and surgical time
2Reliability
If intraoperative frozen section and touch prep cytology are used to assess tumor margins, then the need for re-excision can be reduced, but these techniques have not been widely adopted due to limited coverage of tumor margins (less than 1% of the margins are examined)
Solution Approach 1:
The patent divides the tumor margin assessment into multiple discrete measurement points distributed across the entire margin surface. By positioning multiple optical probes at different locations, the system can systematically survey the entire margin area rather than examining only a small portion, thereby increasing coverage from less than 1% to comprehensive coverage while maintaining assessment reliability
Solution Approach 2:
The patent transitions from two-dimensional surface examination to three-dimensional optical property measurement. The optical probes detect tumor cells throughout the tissue depth, providing volumetric assessment that complements surface examination and enables comprehensive margin coverage by examining multiple depth levels at each measurement point
3Ease of manufacture
If pathologist examination is used to assess tumor margins, then the assessment can be performed with existing infrastructure, but the process requires prolonged surgical time and specialized personnel training
Solution Approach 1:
The patent enables the surgical system to perform self-diagnosis through automated optical detection. The optical assay system automatically identifies tumor cells and provides margin status determination without requiring pathologist expertise, transforming the process from expert-dependent to system-independent and eliminating the need for specialized personnel training while maintaining infrastructure compatibility
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 rapid and reliable intraoperative assessment of tumor margins, reducing the need for re-excision surgeries by providing a robust and efficient method for determining the extent of tissue removal, thereby improving surgical outcomes.
Implementation Method 1
detecting electromagnetic radiation reflected from or emitted by a biological sample
Implementation Method 2
A plurality of electromagnetic radiation probes is provided for illuminating the plural locations of the biological sample via the probe receiving locations with electromagnetic radiation generated by an electromagnetic radiation source and for detecting electromagnetic radiation reflected or emitted by the biological sample via the probe receiving locations
Data Source
AI summary
The subject matter described herein includes an optical assay system for intraoperative assessment of tumor margins. According to one aspect, the subject matter described herein includes a biological sample containment and illumination apparatus for holding a biological sample for illumination by a plurality of electromagnetic radiation probes. The biological sample containment and illumination apparatus includes a plurality of frame members positioned with respect to each other to form an interior space for receiving a biological sample. At least one of the plurality of frame members includes a plurality of probe receiving locations for receiving a plurality of electromagnetic radiation probes. The probe receiving locations position the probes with respect to the biological sample to allow illumination of plural locations of the biological sample by the probes.