Intraoperative Imaging System for Microscopic Disease Detection
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Solution Overview
Problem
Current surgical methods struggle to visualize and remove microscopic residual disease (MRD) and microscopic lymph node involvement (mLNI) intraoperatively, leading to increased recurrence rates and the need for additional treatments, as existing imaging technologies are ineffective in real-time identification during surgery.
Innovation Solution
An intraoperative imaging system using a photosensitive array of optical detectors with a method of illumination and image processing to enhance spatial resolution, coupled with a targeted molecular agent for labeling cancer cells, allowing for time-gated imaging and background subtraction, enabling real-time visualization of tumor cells within the tumor bed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional surgical methods are used without specialized imaging, then the surgical procedure is simple and quick, but microscopic residual disease cannot be visualized leading to incomplete resection
Solution Approach 1:
The imaging system is integrated within the surgical resection device itself, with the photosensitive array embedded in the distal end of the surgical instrument. This nesting approach allows the imaging functionality to be contained within the existing surgical device structure, minimizing additional complexity while enabling microscopic disease detection during resection.
Solution Approach 2:
The surgical device is designed to perform multiple functions: mechanical resection of tissue and simultaneous optical imaging of microscopic disease. The distal end of the resection device incorporates a photosensitive array that can detect fluorescent signals from labeled cancer cells, allowing the same device to both cut tissue and image residual disease, eliminating the need for separate imaging equipment.
2Reliability
If additional margins of healthy tissue are removed to ensure complete resection, then the chance of leaving microscopic disease behind is reduced, but morbidity and risk to healthy tissue increase
Solution Approach 1:
The patent uses fluorescent molecular agents that bind to cancer cells, causing them to emit light at specific wavelengths when excited. This optical signaling creates a visual contrast between malignant and healthy tissue, allowing surgeons to precisely identify and remove only cancerous cells while preserving healthy tissue, thereby reducing morbidity while maintaining complete resection reliability.
Solution Approach 2:
The imaging system provides real-time visual feedback during the resection process, allowing the surgeon to continuously monitor the resection bed for residual fluorescently-labeled cancer cells. This immediate feedback enables the surgeon to adjust the resection boundaries dynamically, removing tissue only where cancer cells are detected, thus avoiding unnecessary removal of healthy tissue while ensuring complete cancer removal.
3Measurement precision
If definitive identification of microscopic residual disease is performed using molecular staining and microscopic visualization in pathology laboratory, then accurate detection is achieved, but the timing is too late for intraoperative guidance
Solution Approach 1:
The patent replaces the mechanical process of tissue sectioning, staining, and microscopic examination performed in the pathology laboratory with an optical detection system. The photosensitive array detects fluorescent signals emitted by cancer cells labeled with molecular agents, providing immediate visual identification of microscopic disease during surgery without requiring tissue processing delays.
Solution Approach 2:
Molecular agents that bind to cancer cells are administered to the patient before surgery, allowing the cancer cells to be pre-labeled and ready for detection. This preliminary labeling action enables the imaging system to detect microscopic disease immediately during the surgical procedure, eliminating the time delay associated with post-operative pathology processing.
4Productivity
If crude methods are used to evaluate tumor in the operating room, then the evaluation can be performed intraoperatively, but the identification of microscopic residual disease is not definitive
Solution Approach 1:
The patent changes the detection parameter from gross visual inspection or crude intraoperative methods to fluorescent optical detection at the cellular level. By using molecular agents that specifically bind to cancer cells and emit fluorescent signals, the system achieves definitive identification of microscopic residual disease with high sensitivity and specificity, far surpassing crude evaluation methods while maintaining intraoperative timing.
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 precise localization and identification of microscopic disease during surgery, reducing the need for additional treatments by ensuring complete resection in a single operation, thereby improving oncologic outcomes and reducing morbidity and costs.
Implementation Method 1
a photosensitive array of optical detectors with a method of illumination and image processing to enhance spatial resolution
Implementation Method 2
targeted molecular agent for labeling cancer cells, allowing for time-gated imaging and background subtraction
Data Source
AI summary
The disclosed apparatus, systems and methods relate to devices, systems and methods for intra-operative imaging.