Disposable Compression Paddle With Detachable Needle Guide
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Solution Overview
Problem
Upright stereotactic biopsies are expensive and require specialized expertise, limiting their use to sophisticated environments, while existing MRI-guided biopsies are time-consuming and costly due to the need for high-precision instrumentation and expensive equipment.
Innovation Solution
A compression paddle assembly with a detachable needle guide, designed for use with existing x-ray mammography or tomosynthesis systems, utilizing low-cost, disposable components to enable accurate and efficient needle biopsies by leveraging high-performance imaging capabilities, allowing for biopsies to be performed with low-cost needle positioning and breast stabilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If dedicated upright stereotactic assemblies with high-precision instrumentation are used, then biopsy accuracy and localization precision are improved, but device cost and operational expense increase significantly
Solution Approach 1:
The compression paddle is designed to serve multiple functions: it acts as both a compression device for mammography and a support structure for needle biopsy guidance. The grid system with numbered positions and lettered rows provides localization capabilities without requiring a dedicated stereotactic assembly, allowing one device to perform multiple biopsy-related functions.
Solution Approach 2:
The grid system acts as an intermediary between the imaging system and the biopsy needle. Instead of requiring complex dedicated stereotactic instrumentation, the grid provides a simple reference framework that works with existing mammography equipment to achieve accurate needle positioning through coordinate-based localization.
2Measurement precision
If complex localization equipment and dedicated stereotactic assemblies are used, then needle positioning accuracy is improved, but procedure time and operational complexity increase
Solution Approach 1:
The grid is pre-positioned on the compression paddle with predetermined numbered positions and lettered rows before the biopsy procedure begins. This preliminary setup eliminates the need for complex real-time localization calculations during the procedure, allowing rapid needle positioning by simply referencing the pre-established coordinate system.
Solution Approach 2:
The compression paddle surface is segmented into a grid system with discrete numbered positions and lettered rows. This segmentation divides the continuous positioning problem into discrete, easily referenceable locations, simplifying the localization process and reducing the time required to identify and access target positions.
3Device complexity
If disposable low-cost components are used instead of dedicated instrumentation, then device cost is reduced, but mechanical stability and positioning reliability may worsen
Solution Approach 1:
The compression paddle with grid system is designed as a disposable component that can be discarded after use. This eliminates the need for expensive dedicated stereotactic assemblies while providing sufficient positioning reliability for the procedure. The disposable nature ensures consistency and eliminates wear-related reliability issues.
Solution Approach 2:
The grid system is merged directly into the compression paddle structure, creating a single integrated component. This combination ensures that the grid and paddle move together as one unit, maintaining relative positioning stability and reliability without requiring separate adjustment mechanisms that could introduce error or reduce reliability.
Data Source
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AI summary
A system and method for performing breast needle biopsies is described. Using the concepts of the present invention, needle biopsies may be performed using low cost, disposable components and leveraging the high performance imaging capabilities of present mammography or tomosynthesis system to achieve results similar to those provided by dedicated upright stereotactic assemblies having dedicated, high precision instrumentation. The components of the present invention may include a compression paddle having a support structure sized to position a needle guide in either a CC or lateral orientation. The support structure is advantageously detachable from the compression paddle. The compression paddle may be packaged in a disposable kit including the needle guide, an introducer and a stylet. Such a disposable kit may be distributed with a biopsy needle of varying types including a core biopsy needle and vacuum assisted biopsy needle.