Integrated Tissue Sensor Tool for Clean Margin Assessment
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Solution Overview
Problem
Current breast conserving therapy faces challenges in accurately localizing tumors due to difficulties in guide wire placement, estimating tumor extent, and ensuring a clean margin of healthy tissue during surgical excision, leading to potential re-excision procedures and aesthetic and emotional impacts on patients.
Innovation Solution
A hand-held, integrated tool equipped with a tissue-type sensor and a distance-measuring sensor for real-time determination of tissue type and clean margin width, allowing for continuous imaging and correction of the incision path during tumor removal, ensuring complete excision with healthy tissue margins.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If guide wire placement is used to localize tumor, then tumor localization is achieved, but placement accuracy and reliability are poor
Solution Approach 1:
The patent replaces the mechanical guide wire placement system with an imaging-based localization system. The imaging modality (mammography, CT, ultrasound) provides visual guidance for tumor localization, eliminating the need for physical guide wire insertion and improving both accuracy and reliability through real-time imaging feedback.
Solution Approach 2:
The patent introduces an imaging modality as an intermediary between the surgeon and the tumor. The imaging system acts as a mediator that provides visual information about tumor location and extent, enabling more precise localization without relying on mechanical guide wires that are difficult to place accurately.
2Reliability
If larger tissue margin is removed to compensate for imprecision, then clean margin is ensured, but aesthetic impact and tissue loss increase
Solution Approach 1:
The patent replaces imprecise mechanical estimation of tumor extent with imaging-based visualization. The imaging modality allows the surgeon to see the actual tumor boundaries, enabling precise excision that maintains clean margins while minimizing the amount of healthy tissue removed, thereby reducing aesthetic impact.
Solution Approach 2:
Instead of removing excessive tissue to compensate for imprecision, the patent enables precise action by using imaging guidance. The surgeon can remove exactly the amount of tissue needed - sufficient to ensure clean margins but no more - eliminating the need for over-resection that causes aesthetic problems.
3Measurement precision
If real-time imaging is implemented, then clean margin assessment is improved, but device complexity increases
Solution Approach 1:
The patent merges multiple functions into a single integrated tool: the imaging modality, the sensor for detecting tissue properties, and the measurement system are combined in one device. This integration allows real-time clean margin assessment during surgery without requiring multiple separate complex systems.
Solution Approach 2:
The integrated tool performs multiple functions: it provides imaging of the tumor, detects tissue properties through sensors, measures clean margin dimensions, and guides the excision process. This multi-functionality reduces the need for multiple separate devices and streamlines the surgical workflow.
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 a clean margin and precise tumor removal, reducing the need for re-excision and improving patient outcomes by ensuring all cancerous tissue is contained within healthy tissue, minimizing tissue removal and aesthetic impact.
Implementation Method 1
a sensor for detecting electromagnetic properties of the examined tissue
Implementation Method 2
a sensor for measuring a distance to an interface with another type of tissue
Data Source
AI summary
An integrated tool is provided, having a tissue-type sensor, for determining the tissue type at a near zone volume of a tissue surface, and a distance-measuring sensor, for determining the distance to an interface with another tissue type, for (i) confirming an existence of a clean margin of healthy tissue around a malignant tumor, which is being removed, and (ii) determining the depth of the clean margin. The integrated tool may further include a position tracking device and an incision instrument. The soft tissue may be held within a fixed frame, while the tumor is being removed. Additionally a method for malignant tumor removal is provided, comprising, fixing the soft tissue within a frame, performing imaging with the hand-held, integrated tool, from a plurality of locations and orientations around the soft tissue, reconstructing a three-dimensional image of the soft tissue and the tumor within, defining a desired clean margin on the reconstructed image, calculating a recommended incision path, displaying the recommended path on the reconstructed image, and cutting the tissue while determining its type, at the near zone volume of the incision surface. The method may further include continuously imaging with the cutting, continuously correcting the reconstructed image and the recommended incision path, and continuously determining the tissue type, at the near zone volume of the incision surface.